key: cord- - ddb de authors: meslin, eric m.; garba, ibrahim title: biobanking and public health: is a human rights approach the tie that binds? date: - - journal: hum genet doi: . /s - - - sha: doc_id: cord_uid: ddb de ethical principles guiding public health and genomic medicine are often at odds: whereas public health practice adopts collectivist principles that emphasize population-based benefits, recent advances in genomic and personalized medicine are grounded in an individualist ethic that privileges informed consent, and the balancing of individual risk and benefit. indeed, the attraction of personalized medicine is the promise it holds out to help individuals get the “right medicine for the right problem at the right time.” research biobanks are an effective tool in the genomic medicine toolbox. biobanking in public health presents a unique case study to unpack some of these issues in more detail. for example, there is a long history of using banked tissue obtained under clinical diagnostic conditions for later public health uses. but despite the collectivist approach of public health, the principles applied to the ethical challenges of biobanking (e.g. informed consent, autonomy, privacy) remain individualist. we demonstrate the value of using human rights as a public health ethics framework to address this tension in biobanking by applying it to two illustrative cases. at first blush, the ethical foundations guiding public health and genomic medicine are at odds: whereas public health practice adopts collectivist principles that emphasize utilitarian and population-based benefits, genomic (and especially personalized) medicine is squarely grounded in an individualist ethic that emphasizes autonomous decisionmaking for personal benefits. one definition of public health illustrates its breadth and focus: the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors -biological, behavioral, social, and environmental -in developing effective interventions (childress et al. ) . lawrence o. gostin ( ) further highlights the critical role of collective entities like communities and governments in ensuring the public's health because although individuals, given the means, can do many things to protect their own health, there are health benefits such as a healthy environment, safe roads, potable water and clean air that require ''organized and sustained community activities''. in short, public health programs deliver to populations health benefits that cannot be effectively secured on an individual or small group basis (childress et al. ) . in contrast, genomic medicine-sometimes conflated with personalized medicine-has been described as an endeavor that ''will provide a link between an individual's molecular and clinical profiles, allowing physicians to make the right patient-care decisions and allowing patients the opportunity to make informed and directed lifestyle decisions for their future well-being'' (ginsburg and mccarthy ) . it envisions medical care in which ''drugs and drug doses are made safer and more effective because they are chosen according to an individual's genetic makeup'' (lesko ) . others, such as the ickworth group (burke et al. ) , characterize personalized medicine as any medical ''care that is tailored to the individual or stratified by the population subgroup''. common to all of these definitions is the emphasis on customizing therapy to the individual patient. indeed, for as long as clinicians have been caring for patients, medicine has been personalized (ramsey ) , but it is the accelerant of genetic technology that has led some to think that today's medicine has the potential to be even more ''personalized'' than its historical predecessors. of course, with the benefit of further reflection, the contrast between personalized medicine and public health is not so stark. for instance, the collectivist approach of public health does not preclude a role for clinical interventions and choices at the individual level. moreover, the claim that the treatment of a sick individual improves the health of the population of which she is a member is all but tautologous. vaccination is an example that fits both conditions. seen this way, personalized medicine and public health are not mutually exclusive, but rather incompletely overlapping. the goals of public health practice certainly include the impact on the health of individuals, and included in the potential value of a genomic approach to medical care is its generalizability to the public's health, for example through better screening and prevention programs (burke et al. ). recognition of this potential for demonstrating the relationship between public health and genomics is evident in a new area of study complete with its own journal, public health genomics that hopes to address some of these very issues. it has been noted, for instance, that a better understanding of what lies between the genes that make up the genome, the role of the environment on gene expression and the role of the interaction between genes will help us to know why some individuals remain healthy while others are more susceptible to genetic diseases. this understanding will also benefit the public health sector where the prevention and expression of communicable and infectious diseases, for example, is related in part to understanding genetic susceptibility… ). the ickworth group recently examined the potential for genomics and personalized medicine to inform public health practice and concluded that much still needs to be done before the promise can be realized (burke et al. ) . in particular, they made six recommendations: . efforts to integrate genomics into public health and practice should continue. . an appropriate research infrastructure for generating an evidence base for genomic medicine needs to be established and maintained. . model public health genomics programs and clinical services need to be developed, implemented and evaluated. . international collaborations should be promoted. . appropriate genetic services and genome-based research should be fostered within low and middle income countries. . programs, research and strategies in public health genomics should be informed by accepted ethical principles and practices. such qualified support for the potential for genomic impact on public health is not surprising, as others have commented on the status of promises made and kept (evans et al. ; hall et al. ) . biobanking is a useful case study to unpack issues at the intersection of genomics and public health. the storied history of the many uses of biological materials that help to improve the understanding, clinical diagnosis and treatment of human disease is long and impressive with detailed reports of the clinical value of banked specimens dating to the early eighteenth century (ackerknecht ; korn ) . without access to stored specimens of blood, urine, tumors, body tissues, dna and other human biological materials, important advances in cancer, infectious disease, cardiovascular care and mental disorders would not have been possible (nat'l bioethics adv. comm. ) . for example, the pap smear would not have been developed (younge et al. ) and the nonsteroidal estrogen hormone, diethylstilbestrol (des), would not have been found to be carcinogenic (herbst ) . without the knowledge gained from autopsies of korean war veterans, science would have known less about the age of onset for atherosclerosis (enos et al. ) . moreover, the cdc would not have been able to isolate and understand the hantavirus (wrobel ) and researchers would not have been able to make progress on certain brain tumors . no doubt researchers hoping to understand the impact of radiation leaks on residents near the fukushima nuclear plant in japan will make use of the chernobyl tissue bank established in to study the effects from (until this point) the world's foremost nuclear plant disaster (http://www. chernobyltissuebank.com). the completion of the human genome sequence (and other genomes) greatly expanded the capacity of science to use and obtain greater value from both previously collected biological specimens and those still to be collected (meslin and quaid ) . for example, the international community, led by canadian researchers, was able to rapidly sequence the sars virus from obtained specimens (marra et al. ) . others used similar technology for the h n virus (graham et al. ; zhang and chen ), dramatically shortening the time it took to understand the nature of the threat and prepare a public health response. moreover, the prospect of using genome technology on already stored specimens for enhanced genetic diagnostics, drug development, and even domestic and international security threat analysis (meslin ; bugl et al. ; atlas ) offers a glimpse into the future of a genetically-informed public health capacity for nation-states. indeed, it is the fortuitous combination of genomics and pharmacology that gives rise to the most promising example of personalized medicine-the field of pharmacogenomics (evans ; evans et al. ; desta and flockhart ) . just as the past benefits to human health from using banked human biological materials stand on their own merit, any future benefits will need to be assessed over time. for us, the important challenge is whether the ethical and legal basis for using banked materials is sufficient to support its expanded use in more areas of public health practice and research. in other words, while we acknowledge that the boundary between the two domains is by no means a stark one; the failure to appreciate what makes them different may prevent productive engagement between these two domains of health care to serve the health interests of society. several explanations have been offered for why public health approaches to health and disease differ from clinical medical approaches, each of which have ethical valence. one theory credits medicine's increasing focus early in the twentieth century on treating the biological causes of disease, and public health's contrasting occupation with the social and environmental causes of illness, resulting in efforts geared toward health promotion and prevention (khoury et al. ). the vectors of medicine and public health diverged further when schools of medicine and public health in the united states were officially separated in (khoury et al. ), in part due to the conflicting goals of professionals in the fields (porter ) . additional ideas include ''the rise of medical authority with the expansion of hospital-based specialist practices'' (porter ) as well as a corresponding split between individualist and collectivist modes of analysis in the social sciences (arah ). this disciplinary, professional and institutional dissociation between the two fields has been blamed for the current gap between personal medical care and public health (arah ). the public health approach presupposes that an exclusive focus on the treatment of individuals is not sufficient to protect, promote and sustain effectively the health of a population. this is evident in the work and writings of public health practitioners such as the sanitarians (susser and susser a) , thomas mckeown (szreter ) , geoffrey rose (marmot ) , dan e. beauchamp (kass ) , marc lappe (kass ) , marvin susser (susser and susser b) , ezra susser (march and susser ) , norman daniels (kass ) , paula braveman (braveman et al. ) and the world health organization (who) commission on the social determinants of health among numerous others (marmot ) . whatever the historical source of the ''schism'' between clinical medicine and public health (khoury et al. ), the gap between them translates directly into the ethical plane. the individuating drive of personalized medicine could make the breach felt all the more keenly, especially when values of individual and population health conflict. for instance, genomics research has focused on ''individually rare single gene disorders,'' prompting warnings that such investments redirect limited resources from ''efforts to address the social and environmental causes of ill health'' (khoury et al. ) . moreover, the challenge of ethical analysis is exacerbated by a disparity in the maturity of ethical frameworks governing medicine and public health. whereas early bioethics scholarship often focused on the individual patient receiving care and to ethical principles supporting this relationship, a similar comprehensive and widelyaccepted ethical framework for public health is yet to be established (nixon and forman ; mann ; callahan and jennings ) . tellingly, nancy e. kass ( ) observes that the language of public health was conspicuously absent among the early bioethicists, despite some achievements with implications for public health ethics. daniel callahan and bruce jennings ( ) likewise point out the focus in bioethics on novel medical technologies in clinical settings at the expense of social and economic inequities. another reason an individualist outlook has prevailed in bioethics is that some public health interventions are conducted on the individual rather than the population level. for instance, postwar antismoking campaigns in great britain set a trend that involved educating and influencing individual behavior and lifestyles (porter ) . the approach, later adopted to combat heart disease, obesity and cancer, helped solidify the individualist and behavioral model already prevalent in clinical medicine (beauchamp ; porter ) . hence, the population perspective implicit in public health ethics was at times at odds with the individualist methods employed to serve the public's health. a further rationale for the individualist bias of hum genet ( ) : - bioethics is the backlash against the misuse of populationbased policies in the field of eugenics, resulting in an understandable suspicion of collectivist bioethical analysis (pernick ; kirkman ; lombardo ). these factors have combined to generate a rich framework for ethical analysis, but one that has remained individualist in orientation. the inadequacy of the framework was noted by bioethicists such as dan e. beauchamp who argued, against the prevailing political valorization of individual autonomy, that a framework that privileged ''individual interests'' and ''market justice'' was detrimental to public health (kass ). beauchamp suggested that public health might require its own ''ethic,'' a proposal taken up by marc lappé ( ) who differentiated medical ethics from public health ethics. as the new millennium unfolded, several efforts were undertaken to establish frameworks for public health ethics. among these was the american public health association's (apha) adoption of the public health code of ethics in early . the apha was the first national organization to adopt the code (thomas et al. ) , which is based on the public health leadership society's principles of the ethical practice of public health. the code is relatively narrow in scope, catering primarily to an audience in traditional public health institutions such as public health departments and schools of public health (thomas et al. ) . moreover, it focuses on public health practice rather than research, and has in view the united states' public health system. meanwhile, efforts were underway to mainstream another and more comprehensive ethical framework for public health ethics in the form of human rights. the appeal and promise of human rights as an ethics framework for public health was articulated by the late jonathan mann: given that the major determinants of health status are societal in nature, it seems evident that only a framework that expresses fundamental values in societal terms, and a vocabulary of values that links directly with societal structure and function, can be useful to the work of public health. for this reason, modern human rights, arising entirely outside the health domain, and seeking to articulate the societal level preconditions for human well-being, seems a more useful framework, vocabulary, and template for public health efforts to analyze and respond directly to the societal determinants of health than any framework inherited from the past biomedical or public health tradition. (mann ) apart from the capacity of human rights to speak in ''societal terms,'' a crucial part of mann's argument was his identification of the goals of human rights as virtually inseparable from those of health, i.e., human well-being (mann ) . although a human rights perspective has the practical advantage over other frameworks of being realized in (mostly international) law, it also benefits from being rooted in an established and fertile ethical vision. human rights can be traced back to the ancient world, but we describe here the prevailing view, which has origins in the writings of such philosophers as hugo grotius, thomas hobbes, jean jacques-rousseau and john locke. modern human rights assume that all persons possess inherent dignity and certain inalienable rights by the simple fact of their being human. the words ''inherent'' and ''inalienable'' mean these things belong to them naturally and are not granted to them by any political authority. to advance their individual and common well-being, however, people give up certain rights to set up a government that serves their needs. a functioning human rights framework is based on the proposition that a government should not take more rights from people than people give to the government in the first place. on this view, the government exists to ensure the well-being of the individuals who give up certain rights in exchange for certain protections and benefits from the government. the same applies to the community they jointly establish. from this analysis, the traditional roles of government include such things as collective security, the administration of justice, the protection of property and, relevant for our purposes, the promotion of the public's health. seen in this way, a human rights perspective provides an ethical framework for describing the conditions under which the government can protect and promote both individual and community well-being. with the onset of the cold war, however, rights that were part of a single ethical vision in the universal declaration of human rights ( ) were gradually split into two categories. the two classes of rights reflected the ideological priorities of the contending sides and were enshrined in two separate treaties in the s. the international covenant on civil and political rights ( ) (iccpr) reflected the capitalist and liberal emphasis on such rights as free speech, freedom of movement, freedom of religion, the right to vote and the right to privacy. these civil and political rights required governments to refrain from interfering with the liberties of their individual citizens. on the other hand, the international covenant on economic, social and cultural rights ( ) (icescr), spearheaded by the communist eastern bloc, focused on such priorities as the right to work, the right to housing, the right to education and the right to health-rights that require governments to take some kind of action for the benefit of the whole society. in part due to their being costlier than civil and political rights and also because of their questionable justiciability (i.e., their enforcement in courts of law) (tarantola ) , social and economic rights were not given the same priority as civil and political rights by governments. the main result of this focus on individualist civil and political rights is that many governments have not invested as heavily in addressing issues at societal or population level-issues such as housing, education and health. hence, human rights norms in the twentieth century have developed along broadly individualist rather than collectivist lines. roberto adorno ( ) describes the potential for human rights as a framework for biomedicine and public health in the global context. he notes that ''[a]s our world becomes increasingly interconnected and threats to the global public health continue to proliferate, it is hard to see how the global governance of health could be managed without assigning an integral role to human rights''. the reasons he provides in support of a human rights framework include the fact that much biomedical activity has clear human rights implications (e.g., the rights to life and physical integrity); human rights have developed into a transcultural ethical discourse with the potential for setting common standards; and there are few if any other viable mechanisms that can serve as a ''global normative foundation''. considering the then incipient unesco universal declaration on bioethics and human rights, t. a. faunce ( ) noted the increasing application of human rights to address challenges traditionally considered within the sole purview of bioethics and medical ethics. in the narrower context of genomics, knoppers ( ) has argued that benefit-sharing in the context of genetic research ''is an aspect of fundamental human rights and serves to counterbalance the effects of commercialization and patenting''. she has also proposed human rights as a compelling model for policy governing new genetic technologies (knoppers ) . these developments notwithstanding, commentators have been quick to point out the limitations of adopting human rights approach for public health and genome-based medicine. meier and mori ( ) criticize the ''limited, atomized right to health'' contained in the icescr, a provision that establishes neither a robust individual right to health nor an effective means of ensuring public health. similarly, adorno ( ) acknowledges the criticism ''that human rights are conceived as excessively individualist for non-western mentalities and lack a significant concern for personal duties and for the common interest of society''. with particular reference to the field of genomics, iles ( ) points to two specific shortcomings of human rights as an ethical framework, both of which are traceable to the individualist orientation of the current system. his first criticism is that such a framework pays inadequate attention to the structural and social effects of genetic information. he argues that because economic, racial, ethnic and power disparities already exist between groups in societies, genetic information used without ethical oversight can exacerbate these differences and result in discrimination and exclusion. iles infers that human rights may adequately protect individuals facing genetic profiling in employment or insurance contexts, but it is questionable whether the framework's individualist lens can monitor the effects of genetic information on relations between and among groups. iles' second criticism of the applicability of human rights as a foundation for ethical uses of genomics is that individual freedom of choice regarding the use of genetic information can have an aggregate population-wide effect. for example, the choice parents make to have a ''normal'' child rather than one with a ''comparatively inert and tolerable'' disorder is not only heavily influenced by society's values but also determines eventually the society's constitution (iles ) . a narrow focus on individual choice, therefore, may obscure the effects of the uses of genetic information on a society. the preceding discussion demonstrates that even human rights as a framework for public health ethics are not immune from the individualist approach that characterized early bioethics. toward the end of the cold war, however, there were renewed efforts to reintegrate the individualist civil and political rights with the community-oriented economic and social rights (meier and fox ) . we outline three of these developments below. the first development is the increasing recognition of a category of rights known as ''solidarity'' or third-generation rights (wellman ) . the phrase ''third-generation'' distinguishes solidarity rights from the more individualist civil and political rights (''first-generation'' rights) and the more collectivist social, economic and cultural rights (''second-generation'' rights). like the other two generations of rights, solidarity rights were a response to a particular set of problems facing the international community. these included ''securing peace after the first and second world wars, achieving freedom for colonial peoples, reducing the gross economic inequalities between developed and underdeveloped countries, and preserving a healthy environment when the technologies in one nation seriously damage an environment shared by all nations'' (wellman ) . solidarity rights, in other words, are aimed at conditions that can be addressed only by global efforts rather than the laws of any single country. the classic examples of solidarity rights are the rights to peace, development, a healthy environment, self-determination, humanitarian intervention, communication and ownership of the common heritage of humankind (wellman ; monshipouri et al. ) . apart from requiring the concerted efforts of all countries, solidarity rights have two other criteria: first, that the rights belong to peoples (i.e., groups), not just individuals; second, that obligations apply to all actors on the international scene, not just governments. more recently, solidarity has been described as a key ethical foundation for biobanks (chadwick and berg ) . from an ethical perspective, solidarity rights complement first-and second-generation rights. whereas firstgeneration rights protect individuals from the abuses of their governments (e.g., no torture or arbitrary arrests), and second-generation rights enable individuals to claim benefits from their governments (e.g., education, housing), solidarity rights recognize that individuals cannot reach their full potential without ''cooperative participation in the social life of the various communities to which they belong'' (wellman ) . hence, solidarity rights further establish in human rights the ethical principle that human well-being has a communal dimension that goes beyond an individual citizen's relationship with her government. the second development emphasizing a collectivist approach in human rights is growth in the area of indigenous peoples' rights. the united nations general assembly adopted the declaration on the rights of indigenous peoples in . what makes this declaration unique is that it explicitly recognizes a category of ''collective'' rights. until the declaration's adoption, human rights were concerned primarily with ''the rights of the individual against the state, without much attention to the collective and associational dimensions of human existence beyond the state'' (anaya ) . in an historic shift, the declaration recognizes rights to indigenous peoples as groups rather than merely as individual members of their communities. it is a particular instance of the ethical principle underlying solidarity rights, which proposes that community is not an elective component of human well-being. this development, moreover, has significant ethical implications for the involvement of indigenous peoples in research and in access to health benefits, and exemplifies the relevance of indigenous perspectives on genomics research generally (dodson and williamson ) . the third and final development pertains to regional human rights instruments. the major global regions are encouraged to adopt their own treaties, thereby customizing global human rights norms to their particular situations for more effective implementation. of particular relevance is the african charter on human and peoples' rights (also known as the banjul charter), which was adopted by the organization of african unity (now the african union) in , and which includes ''a mixture of all three generations of rights'' (shepherd ) . as its official title suggests, the banjul charter includes the concept of peoples' rights, which, like the collective rights of indigenous peoples, is a version of group rights. the banjul charter deliberately omits a definition of the term ''people,'' thereby leaving the term open to several interpretations, e.g., persons struggling to gain political independence, persons living in a territory and sharing certain characteristics, or simply all people living in a country (kiwanuka ) . whatever their precise legal definition, peoples' rights in the banjul charter are based on the african philosophical belief that a human being is not ''an isolated and abstract individual, but an integral member of a group animated by a spirit of solidarity'' (kiwanuka ) . the kinship between this african principle and the ethical norms undergirding solidarity rights and the rights of indigenous peoples discussed above is evident. they all recognize the importance of community to human wellbeing and reject an approach to human rights that focuses exclusively on the individual. these three developments demonstrate how human rights have been finding ways to complement the protection of individual rights with approaches that recognize the ethical importance of community. these attempts to expand the vision of human rights beyond the individual are analogous to the efforts of public health ethicists to develop a population perspective that transcends the clinical encounter between a single patient and her caregiver. this similarity makes the human rights framework a compelling candidate for analyzing the ethics of biobanking and public health. as with early debates in medical ethics and bioethics generally, much of the ethical and legal attention in biobanking has been individualistic, focusing on informed consent (beskow and dean ; brekke and sirnes ) , privacy protections (chen et al. ; evans ) , and risks of exploitation, especially in vulnerable populations (lo ; bernhardt et al. ; dodson and williamson ) . important as these topics are, some now believe the time has come to update the ethical/legal dialog about biobanks to accommodate broader social and political perspectives (meslin and cho ; kaye ; caulfield et al. ) . it is against this backdrop that our analysis is set. a human rights approach may offer two advantages over other potential public health ethics frameworks. first, it may avoid having to resolve the seemingly interminable debate about the proper approach to obtaining individual informed consent for research using human biological materials. in situations in which groups may be consulted, approached and from which permission to participate in biobanks may be sought, informed consent may be necessary but not a sufficient mechanism for engaging a community. second, it recognizes the institutionalization and application of human rights discourse at international forums by providing tools for discussing the values of public health across national borders. this is important in light of observations by recent commentators of a linguistic shift with both practical and ethical implications: the gradual transition of the term ''international health'' to ''global health.'' ''international health'' was used to describe a technical endeavor conducted jointly by developing countries and their partners in the industrialized world through such large institutions as the world health organization (who) and care international (elmendorf ) . it was useful in this context to distinguish between ''international'' and ''domestic'' health. in contrast, the term ''global health'' reflects an acknowledgment that intensifying interaction between countries through trade and travel renders national borders increasingly immaterial for health challenges (elmendorf ) . the shift in terms represents the change from health conceived as an issue for diplomacy and knowledge transfer between countries to health conceived as a common asset and concern of the international community. importantly, the terminological shift from ''international'' to ''global health'' is also reflected in the bioethics literature (chadwick et al. ) . a specific example of the application of ''global'' rather than ''international'' health is the ''one world, one health'' initiative, a framework that builds on efforts to contain the avian influenza outbreak (fao et al. ) . the initiative is built on the premise that infectious diseases have potentially national, regional and international effects, thus requiring approaches that are not only ''interdisciplinary'' and ''cross-sectoral'' but indeed global. the changes signified by the term ''global health'' have implications for biobanking in many ways (burke et al. ) . public health genomics research is becoming ''increasingly international and collaborative'' resulting from the need for larger and more diverse datasets to evaluate genetic differences within groups (ickworth ). aided by more robust bioinformatics, genotypic and phenotypic data will be employed with greater frequency to study the significance of genetic variation (mendoza ). this will involve the use of larger databases and the consolidation of samples from sites around the globe (meslin and goodman ; ickworth ) . this raises the obvious challenge of harmonizing norms concerning privacy and confidentiality across jurisdictions and, beyond that, consideration of the varied cultural norms guiding data sharing particularly when information moves between developed and lower and middle income countries (lmic) (chalmers ; holman et al. ; asslaber and zatloukal ) . biobanking in the global public health arena is also faced with the challenge of determining research priorities given the different health problems facing populations in developed and lmic. although both regions face the complex diseases of urbanization (e.g., cancer, heart disease, diabetes), environmental factors like climate change and resource scarcity are likely to affect lmic more profoundly than their developed country counterparts. this is especially troubling given that a research imbalance exists between the regions: although african populations are ''the 'root and branch of genetic variability''' the bulk of genomic research is conducted by developed countries and among european populations (ickworth ). fortunately, new initiatives such as h africa may begin to redress this historic injustice (nordling ) . these challenges confirm the need for an ethical framework that can be understood and implemented at global forums. s. h. e. harmon ( ) echoes the need for global frameworks ''given the rise of predictive medicine (involving genetic research and clinical genetics), which is driven by private global operators, thereby suggesting a need for regulatory responses which are similarly global''. although a who report on genetic databases concludes that biobanks are based more on ''communal value'' than on ''individual gain,'' the reality is that the ethics of biobanking has been analyzed predominantly in the traditional individualist bioethical categories of confidentiality, autonomy and informed consent (knoppers and chadwick ) . the fact has not been lost on some commentators. garrath williams, for instance, discusses the daunting task of developing ethical principles for large-scale biobanks. he attributes the difficulty in part to an excessive focus on the individual research subject's right to informed consent, an emphasis he finds inconsistent with the inevitably collective nature of large-scale biobanking (williams ) . williams maintains that this conceptual incongruity obscures important ethical questions about how research priorities are set and how to accommodate the diverse motives of actors in health care systems. he warns that ignoring analyses that transcend individualist frameworks may, paradoxically, end up harming the interests of individuals (williams ) . human rights can make no original contributions to the ethics of biobanking if they are incapable of transcending their individualist biases. the second challenge of a human rights framework for biobanking involves developments in global politics. the observation by knoppers and chadwick ( ) that genetic research has compelled ''a public and therefore a political examination of personal and social values'' illustrates the close connection between politics and ethics in biobanking. therefore, ethical analyses of international biobanking and public health that omit the global political context will likely remain deficient. the developments in global politics that pose the greatest challenge to human rights as an ethical framework for biobanking are efforts, in the context of globalization, to entrench policies that entail an increasing delegation of governmental responsibilities to private actors. in a publication on health and human rights, who ( ) notes that [w]ithin the human rights community, certain trends associated with globalization have raised concern with respect to their effect on states' capacity to ensure the protection of human rights, especially for the most vulnerable members of society. located primarily in the economic-political realm of globalization, these trends include: an increasing reliance upon the free market; a significant growth in the influence of international financial markets and institutions in determining national policies; cutbacks in public sector spending; the privatization of functions previously considered to be the exclusive domain of the state; and the deregulation of a range of activities with a view to facilitating investment and rewarding entrepreneurial initiative. these trends serve to reduce the role of the state in economic affairs, and at the same time increase the role and responsibilities of private (non-state) actors, especially those in corporate business, but also those in civil society. this transfer of responsibilities from governments to private actors is critical because the operation of international law depends both on governments assuming legal obligations by signing agreements and on these governments being held accountable for fulfilling the responsibilities they undertake. generally speaking and despite recent changes in international criminal law, private actors are not accountable under public international law, the branch of international law to which human rights belong (jessberger ) . hence, the transfer of governmental responsibilities such as health provision to private actors removes a growing number of issues from the direct supervision of human rights. governments retain the duty to ensure that private actors such as transnational corporations do not violate human rights, but monitoring and enforcing the norms remains a major challenge (gruskin et al. ; tarantola ) . we conclude this discussion with two examples of key ethical issues raised by the prospect of expanding international biobanking: the first addressing differences in national laws governing biobanks, and the second addressing ethical obligations of transnational corporations operating in lmic. various commentators have discussed the problem for international biobanking arising from the absence of common regulations applying across country borders. the regulatory terrain has been depicted as ''a patchwork of national laws, regulations and ethics advisory body guidelines'' (maschke ) , and comparisons have proven ''laborious and defy generalizations'' (helgesson et al. ). the discrepancies in ethical rules governing such issues as consent and secondary uses raise obvious barriers to the principled collection of tissue samples and the development of personalized medicine. adopting human rights as a public health ethic is not an ideal guide for drafting specific rules governing individual focused biobanking issues such as consent, privacy and secondary uses. however, such an ethic can inform efforts to determine the general principles that should govern the activity of biobanking as a broader societal undertaking. human rights can do this by integrating three concepts: ( ) collective rights (from international human rights); ( ) global public goods (from economics); and ( ) the common heritage of humanity (from international environmental law). we have discussed above the welcome and increasing recognition of community-oriented socio-economic rights as well as solidarity rights in international human rights toward the end of the cold war. we noted also how the change was reflected in the explicit recognition of ''collective'' rights in the united nations declaration on the rights of indigenous peoples. these rights ''operate at an international level to assure public goods that can only be enjoyed in common with similarly-situated individuals and thus cannot be realized through individual rights claims against the state'' (meier and fox ) . the premise grounding the recognition of collective rights is that the realization of some human rights is simply not reducible to their exercise by an aggregate of individuals. harmon ( ) writes that social solidarity has been incorporated, even if implicitly, into unesco's major instruments on genomic research, namely the universal declaration on the human genome and human rights ( ) and the universal declaration on bioethics and human rights ( ) . he maintains that the emergent notion of social solidarity mitigates the excesses of modern individualism and is ''grounded in the recognition that individuals are socially embedded''. his analysis of the unesco documents describes a solidarity based on the fundamental unity of all humans, a focus on ''the collective, the observance of duties and the creation and preservation, through personal and collective action, of a just and decent society''. the notion that the human genome is the ''common heritage of humanity'' has been eloquently defended (knoppers a ), but has not avoided the disquiet among some commentators, some of whom suggest that the human genome be classified as a common resource rather than the common heritage of humanity (spectar ; resnik ) . developed in the context of international law governing the management of resources in outer space and the high seas, this concept is founded on three basic principles: ''( ) absence of private property rights i.e. the right [usually of governments] to use resources but not to own them; ( ) international management of all uses of the common heritage; and ( ) sharing of benefits derived from such use'' (white ) . also included in the concept is an obligation to use the resource in a peaceful and responsible way, keeping the resource accessible to all and considering the interests of future generations (knoppers a) . in economic terms, a global public good is a good ''for which the cost of extending the service to an additional person is zero and for which it is impossible or expensive to exclude individuals from enjoying'' (nordhaus ) . a global public good is marked by two criteria: that the good be non-excludable and non-rivalrous. stated differently, ''[a] good is non-excludable if persons cannot be excluded from accessing it, and non-rivalrous if one person's use of the good does not diminish the supply of that good'' (chadwick and wilson ) . a classic example is a lighthouse that lights the sea and which is not diminished in its use by multiple sailors (chadwick and wilson ) . other examples include a global positioning system (gps) whose value is not compromised by multiple users, or the eradication of an infectious disease, the benefits of which cannot be diverted from any susceptible persons (nordhaus ) . it has been argued that both genetic information (knoppers and fecteau ; chadwick and wilson ) and public health (meier and fox ) should be classified as global public goods in this same way. these three concepts have been integrated by several commentators in efforts to develop ethics frameworks for public health and biobanking. meier and fox ( ) consider public health a public good and make a case for its recognition in international law as a collective right. knoppers ( a) notes growing support in international normative documents for the human genome to be classified as the common heritage of humanity, and argues, as do chadwick and wilson ( ) , that genetic databases should be considered a global public good (knoppers and fecteau ; knoppers b; chadwick and wilson ) . the combination of features from all three concepts can provide the basic constituents of a human rights public health ethic for international biobanking. first, collective rights, premised conceptually on the fact that certain rights can be protected only in groups, is virtually analogous to the population perspective of public health, which presumes that certain health challenges require society-wide, rather than individual, interventions. the kinship of the two perspectives is highlighted in the argument made by meier and fox ( ) that public health be recognized as a collective right. second, the classification of genetic databases as the common heritage of humanity, which precludes private ownership while requiring shared uses and benefits, buttresses the view that biobanks should be managed under principles that consider the whole of humanity rather than narrower interests, no matter how seemingly benign. again, these principles would share an affinity with the principles of public health that target the health of the whole population. third, the arguments for the status of genetic information as a non-rivalrous and non-excludable global public good also support an approach to managing biobanks that recognizes the public character of the resource. together, these features ground the management of international biobanking in a framework that keeps foremost the population perspective of public health. biobanking and developments in personalized medicine entail the involvement of private investors. commentators have pointed out the costs associated with this infusion of private funding. they raise concerns that such involvement may influence the type of research, distort the process by restricting the direction of research, prevent collaboration, and restrict the sharing of the raw data generated by the research. it also might prevent the results of the research being disseminated effectively or cause publication bias. most importantly, it may serve to reduce public trust in the research process. some evidence suggests that potential participants may be less willing to engage in research if this is privately funded (as they perceive themselves to be more exposed to potential exploitation) (ickworth ). the risks expand significantly when, as projected, biobanking expands globally. most lmics have vulnerable populations and lax to minimal research regulation. but even where lmic governments have the ability to regulate research activity, we have noted above the growing trend under globalization for governments to delegate traditional responsibilities to private actors. this constitutes a major administrative and ethical challenge in the regulation of biobanks because, as a rule, governments rather than private actors assume international obligations (ratner ). the situation requires an ethical framework for protecting vulnerable populations living under governments either unwilling or incapable of protecting their interests. in , john ruggie was appointed the united nations special representative of the secretary general (srsg) on business and human rights for an initial term of years. ruggie's primary charge was to clarify the human rights obligations of companies operating internationally and the responsibilities of host governments to regulate such businesses (u.n. comm. on human rights ). in extending the srsg's mandate another years in , the human rights council observed that weak national legislation and implementation cannot effectively mitigate the negative impact of globalization on vulnerable economies, fully realize the benefits of globalization or derive maximally the benefits of activities of transnational corporations and other business enterprises and that therefore efforts to bridge governance gaps at the national, regional and international levels are necessary… (u.n. human rights council ) the appointment of the srsg underscores the ethical implications of international trade and politics. it also testifies to the potential of human rights as a framework for addressing global governance challenges. the srsg fulfills his mandate through research, consultations and workshops that lead to recommendations, standards and tools for the use of businesses and other stakeholders. in the course of his mandate, the srsg has developed a human rights framework for business in the global economy. the framework (known as the ''un framework'') has three pillars: the duty of governments to protect their citizens from human rights violations by third parties (particularly international businesses); the responsibility of businesses to respect human rights (typically contained in corporate codes of conduct); and the establishment of remedies for people whose human rights have been violated (u.n. spec. rep. of the sec. gen. ). the un framework provides a useful tool for helping mitigate the regulatory hazards associated with privatelyfunded biobanking enterprises in lmics. by further clarifying the responsibilities of both host governments and foreign investors, the un framework increases the chances that clear laws regulating biobanking will be passed by lmic governments. effective biobanking governance models (kaye and stranger ) are necessary if biobanking is to benefit public health as governments remain the primary actors in public heath practice. moreover, by ensuring the availability of remedies for violations, the un framework reduces the incentive of foreign investors to take advantage of weak and/or corrupt governments unwilling to implement existing biobanking regulations. the un framework was endorsed by the human rights council in june , thereby enhancing its credibility as a global ethical standard for regulating international business activity. this endorsement ensures that the un framework will help guarantee that the projected extension of especially privately financed biobanking to lmics will take into account the public health interests of lmic populations. we have taken the view that one of the ethical challenges raised by genomic medicine reflects an enduring problem in public health: the appropriate balancing of individual and collective values, rights and interests. biobanking in the context of public health genomics reflects a unique case study in this classical problem because it must accommodate both individual and community interests (including multiple types of affected communities). while no single ethical-legal framework has been accepted to bridge this gap, we believe that a renewed attention to a human rights perspective in the context of global health may offer a way forward. medicine at the paris hospital human dignity and human rights as a common ground for a global 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-qwxkn j authors: aceng, jane ruth; ario, alex r.; muruta, allan n.; makumbi, issa; nanyunja, miriam; komakech, innocent; bakainaga, andrew n.; talisuna, ambrose o.; mwesigye, collins; mpairwe, allan m.; tusiime, jayne b.; lali, william z.; katushabe, edson; ocom, felix; kaggwa, mugagga; bongomin, bodo; kasule, hafisa; mwoga, joseph n.; sensasi, benjamin; mwebembezi, edmund; katureebe, charles; sentumbwe, olive; nalwadda, rita; mbaka, paul; fatunmbi, bayo s.; nakiire, lydia; lamorde, mohammed; walwema, richard; kambugu, andrew; nanyondo, judith; okware, solome; ahabwe, peter b.; nabukenya, immaculate; kayiwa, joshua; wetaka, milton m.; kyazze, simon; kwesiga, benon; kadobera, daniel; bulage, lilian; nanziri, carol; monje, fred; aliddeki, dativa m.; ntono, vivian; gonahasa, doreen; nabatanzi, sandra; nsereko, godfrey; nakinsige, anne; mabumba, eldard; lubwama, bernard; sekamatte, musa; kibuule, michael; muwanguzi, david; amone, jackson; upenytho, george d.; driwale, alfred; seru, morries; sebisubi, fred; akello, harriet; kabanda, richard; mutengeki, david k.; bakyaita, tabley; serwanjja, vivian n.; okwi, richard; okiria, jude; ainebyoona, emmanuel; opar, bernard t.; mimbe, derrick; kyabaggu, denis; ayebazibwe, chrisostom; sentumbwe, juliet; mwanja, moses; ndumu, deo b.; bwogi, josephine; balinandi, stephen; nyakarahuka, luke; tumusiime, alex; kyondo, jackson; mulei, sophia; lutwama, julius; kaleebu, pontiano; kagirita, atek; nabadda, susan; oumo, peter; lukwago, robinah; kasozi, julius; masylukov, oleh; kyobe, henry bosa; berdaga, viorica; lwanga, miriam; opio, joe c.; matseketse, david; eyul, james; oteba, martin o.; bukirwa, hasifa; bulya, nulu; masiira, ben; kihembo, christine; ohuabunwo, chima; antara, simon n.; owembabazi, wilberforce; okot, paul b.; okwera, josephine; amoros, isabelle; kajja, victoria; mukunda, basnet s.; sorela, isabel; adams, gregory; shoemaker, trevor; klena, john d.; taboy, celine h.; ward, sarah e.; merrill, rebecca d.; carter, rosalind j.; harris, julie r.; banage, flora; nsibambi, thomas; ojwang, joseph; kasule, juliet n.; stowell, dan f.; brown, vance r.; zhu, bao-ping; homsy, jaco; nelson, lisa j.; tusiime, patrick k.; olaro, charles; mwebesa, henry g.; woldemariam, yonas tegegn title: uganda’s experience in ebola virus disease outbreak preparedness, – date: - - journal: global health doi: . /s - - - sha: doc_id: cord_uid: qwxkn j background: since the declaration of the th ebola virus disease (evd) outbreak in drc on st aug , several neighboring countries have been developing and implementing preparedness efforts to prevent evd cross-border transmission to enable timely detection, investigation, and response in the event of a confirmed evd outbreak in the country. we describe uganda’s experience in evd preparedness. results: on august , the uganda ministry of health (moh) activated the public health emergency operations centre (pheoc) and the national task force (ntf) for public health emergencies to plan, guide, and coordinate evd preparedness in the country. the ntf selected an incident management team (imt), constituting a national rapid response team (nrrt) that supported activation of the district task forces (dtfs) and district rapid response teams (drrts) that jointly assessed levels of preparedness in designated high-risk districts representing category ( districts) and category ( districts). the moh, with technical guidance from the world health organisation (who), led evd preparedness activities and worked together with other ministries and partner organisations to enhance community-based surveillance systems, develop and disseminate risk communication messages, engage communities, reinforce evd screening and infection prevention measures at points of entry (poes) and in high-risk health facilities, construct and equip evd isolation and treatment units, and establish coordination and procurement mechanisms. conclusion: as of may , there was no confirmed case of evd as uganda has continued to make significant and verifiable progress in evd preparedness. there is a need to sustain these efforts, not only in evd preparedness but also across the entire spectrum of a multi-hazard framework. these efforts strengthen country capacity and compel the country to avail resources for preparedness and management of incidents at the source while effectively cutting costs of using a “fire-fighting” approach during public health emergencies. a week after declaring the end of the th ebola virus disease (evd) outbreak in equateur province of the democratic republic of congo (drc) on july th, , the ministry of health of the drc confirmed a new evd outbreak in the eastern drc, north kivu province on august , [ ] . six health zones, including beni, butembo, oicha, mabalako, and musienene in north-kivu province, and mandima in ituri province have since reported confirmed and probable evd cases. within a month, evd cases ( confirmed, probable), including deaths ( % case-fatality rate) had been reported with an additional nine suspected cases pending laboratory testing for evd [ ] . north kivu province shares borders with uganda in the east, and there is frequent cross-border movement due to trade, farming, healthcare, and social activities. in addition, north kivu and ituri provinces have been the centre of interethnic clashes for some time now, and harbor over a million displaced persons, with active rebel activities causing prolonged insecurity. since december , there has been a continuous influx of refugees into uganda, resulting in a high risk of evd introduction into the country. evd is a severe, often fatal illness in humans. initial human infection with ebola virus (ebov) occurs through contact with an infected animal, such as a fruit bat or non-human primate [ ] . the virus spreads from person to person via direct contact with the blood or body fluids of an ebov-infected symptomatic person or dead body. entry of the body fluids (urine, saliva, sweat, faeces, vomit, breast milk, vaginal fluid, and semen) through broken skin or mucous membranes in the eyes, nose, or mouth can lead to infection [ ] . the spread of ebola zaire strain can be effectively prevented through vaccination, as demonstrated by a ring vaccination trial held in guinea during the west african evd outbreak [ ] . guinea was the epicenter and the initial site of the largest-ever evd outbreak, leading to intense transmission in guinea as well as the neighbouring countries of liberia and sierra leone. transmission to neighbouring countries was associated with illprepared health systems and poor inter-governmental coordination, factors that led to poor disease surveillance, insufficient infection prevention and control and clinical care. liberia, guinea and sierra leone had a long history of socio-economic underdevelopment due to civil conflict leading to very weak and severely underresourced health systems. the outbreak was further exacerbated by infected persons crossing the highly porous borders of the countries involved [ , ] . as a result, this outbreak caused significant mortality, with reported case-fatality rates of up to %. evd outbreaks have also occurred in the central african nations of gabon ) , the democratic republic of congo (drc) ( , , , , , , , , ) , sudan( ), and uganda ( , , , ) [ , ] . uganda's largest documented evd outbreak occurred in - in gulu district, registering cases and deaths [ ] . in this paper, we describe uganda's experience in preparedness to prevent evd introduction into the country and limit its spread in case of an outbreak. the approach adopted by the country focused on comprehensively addressing objectives of epidemic preparedness and reponse, including anticipation/prediction so that epidemics do not occur, early detection, and rapid and effective response. the epidemic preparedness process constituted all the activities that were undertaken by moh and its partners from national to health facility levels to enable readiness to effective response to evd outbreak in uganda from august when evd outbreak was declared in the drc to the time of writing this paper. the reports of the national task force (ntf) and its subcommittees were reviewed to inform the content of the paper. the preparedness efforts included activation of coordination mechanisms, functionalising subcommittees of the ntf, classifying districts by risk level and conducting risk assessment and mapping exercise which informed development of the national evd response plan. to assess the country readiness, a major simulation exercise was conducted. the moh activated the public health emergency operations centre (pheoc), ntf and district task forces (dtfs) for coordination of the evd preparedness. the ntf is multi-sectoral and multi-disciplinary in nature and comprises key ministries, agencies, and departments as well as partners and relevant stakeholders and works through its subcommittees (fig. ) . the ntf which is chaired by the director general of health services and co-chaired by who, held an urgent meeting on the nd of august to discuss evd preparedness and prevention of spillover from drc into uganda. the ntf developed a multi-agency incident management system (ims) to coordinate preparedness efforts and guide central and field evd activities. the major ims components are command and management of preparedness activities, resource management, communication, and information management. the ntf assigned an incident management commander (imc) and team, made of technical subcommittee team leads encompassing the eleven key who evd preparedness components, including: ) epidemiological surveillance (contact tracing, capacities at poes, and laboratory incorporated); ) case management and infection prevention and control (ipc) including psycho-social support, waste management and safe and dignified burials; ) risk communication and community engagement; ) vaccination, therapeutics, and research; ) emergency coordination including budgeting and resource mobilisation; and ) logistics [ ]. the imt was responsible for planning and managing preparedness resources and activities, guiding activity implementation through the dtfs, and reporting back progress from each district to the ntf. after the initial risk assessment, districts bordering north kivu and ituri provinces were categorized as high-risk for evd importation, as moderate-risk, and the remaining districts as low-risk. through the ims, all high-risk and moderate-risk districts were supported to formulate and/or reactivate their dtfs to constitute sub-committees for the core preparedness and coordinate interventions at district level. the dtfs comprised the district political, civic, security, and health leadership as well as technical advisors from different partners working in the districts. as a result of the complexity of the evd situation in drc, civil unrest and refugee influx, several national development partners became involved in evd preparedness. the ntf, with support from who, developed a partners' coordination matrix to avoid duplication of efforts, facilitate identification of preparedness gaps, support monitoring of implementation of the preparedness plan and realise the importance of impact on competing health interests. the matrix specified who should be doing what, where, and when (also known as the ws), as well as the evd preparedness goal, objectives, strategies, budget, funding sources, funding gaps, donors, and implementing agencies in the respective high-risk districts. guided by this matrix, the moh and partner institutions provided district-level financial and technical support for preparedness activities (figs. and ). figure shows total amount of money spent by each implementing partner while fig. shows the contribution by each donor to the preparedness efforts. the matrix was updated regularly based on feedback from ntf members. a dashboard was developed and updated promptly to display the financial and technical progress as well as the ws. the ntf classified district evd transmission risk into categories. category included high-risk districts that have physical borders, direct routes, and refugee influx from the affected provinces in drc as well as the central business disticts of kampala capital city and wakiso. category included moderate-risk districts that have physical borders with drc but no direct route to evdaffected regions, and category included low-risk districts in the rest of the country (fig. ) . the ntf deployed the nrrt to the districts to conduct rapid risk assessments and report within the first h of deployment followed by subsequent updates as the outbreak situation evolved. the ntf adapted and used the who evd preparedness checklist to assess the districts' level of preparedness. the checklist is composed of key components and core capacities and tasks for both districts and health facilities that are required for a district to be operationally ready [ ] . through face-to-face interviews with key informants and discussions with the drrt, the nrrt scored activities under each core capacity of preparedness. the assessment team verified responses by looking at documented evidence and implementation of the recommended core capacities at the district and health facility level. the nrrt held group discussions with health facility teams on epidemiological surveillance, case management, ipc, laboratory and contact tracing. scores were assigned to each of the core capacity components (green for complete/in place and red for incomplete/not yet in place) and then percentages of the total tasks that were completed for each core capacity were computed for fig. national budget and financial contribution to evd preparedness by implementing partner each district. any district with a level of preparedness component at ≤ % was considered unprepared (red), between and % was considered as fairly ready (yellow), and those above % were considered prepared for that component. the nrrt used the assessment results to identify capacity gaps for additional support to strengthen alert and response in the high and moderate risk districts. to establish drc population movements and patterns across the drc-uganda border, the population connectivity across borders (pop-cab) tool developed by us cdc was used to document, record, analyze, and map risks associated with population movements across borders. the nrrt held key informant interviews with the district health team (dht), which included the district health officers, surveillance focal persons, health inspectors and health educators, and local leaders at known border poes and along priority porous borders. several official and non-official high-risk crossing points for population movement from drc across border districts were identified. trained facilitators also interviewed township chairpersons, town clerks, subcounty chiefs, mayors, and transport operatives in the high-risk locations. in addition, focus group discussions (fgds) with village leaders, community health workers in the cited high-risk locations for drc population were held. the fgds were guided by an adapted popcab fgd guide to gather information about the type of people crossing the border, their points of origin, congregation points, reasons for entering uganda, duration of their stay and destinations. gps coordinates for each of the locations were recorded. we developed summaries from key informant interviews and focus group discussions aided with sketch maps to track crossborder movements and indicate key locations for the drc population. the facilitators integrated participatory mapping with spatially-accurate, printed maps in the key informant interviews and focus group discussions to identify location information for priority points of interest and travel routes. respondents described population movement patterns associated with refugees who leave the uganda settlements to visit their relatives in drc and return back to uganda. in addition, they described the patterns of persons newly-arriving from the drc to established refugee reception centers and resettlements areas in uganda such as kyangwali in hoima district or kyaka ii in kyegegwa district, as well as drc traders traveling across lakes albert and george to major markets in towns in the ugandan border and non-border districts for business, and others who fly directly to entebbe international airport from goma, eastern drc. the drrt used the results to identify several official and non-official high-risk border locations with population movement from drc into border districts. these exercises revealed multiple drc travelers' destinations to towns as far as uganda's capital city of kampala. a mapping exercise was conducted by the international organization for migration (iom) to establish the numbers, locations, and traveler flow of the numerous non-official border crossing points that exist between the drc and uganda through which people travel for social, business, and health reasons. this enabled with support from development partners and relevant stakeholders, the ntf developed the national evd contingency plan to address the identified gaps in preparedness, and to support timely detection, response, and immediate containment of a potential evd case in uganda. this plan was developed in line with guidance provided in the international health regulations (ihr) for countries to develop core capacities to prevent, protect against, and rapidly respond to public health threats, including evd. the plan was developed based on the rapid assessment preparedness reports, past experiences, and lessons learnt during the previous evd outbreaks in uganda [ ] . the plan was also developed based on the one health approach to global health security at both national and subnational levels. this approach requires coordination across multiple sectors of government including human and animal health, agriculture, wildlife, water and environment, security, immigration and law enforcement. framework for each of the components of preparedness and was costed accordingly. it highlighted a package of interventions for the districts in the risk categories. after several cross-border contacts were made and points of entry coordination exchanges took place at local levels, the ntf and moh engaged with the drc ministère de la santé publique (ministry of public health) to convene a cross-border health meeting. attendees included the east african countries at risk of introduction of evd cases from the drc in october . following this meeting, a bilateral ministerial meeting was held in goma, drc, in december . the first meeting was designed to formalize crossborder collaboration and local-level exchange of information between affected countries, meanwhile the second meeting was meant to result in developing and signing of the uganda-drc memorandum of understanding (mou) on cross-border collaboration for public health preparedness and response. the mou enabled establishment of four surveillance zones between uganda and the drc. the nrrt trained dhts, health and non-health frontline workers including members of security forces, village health teams (vhts) and political leaders on evd case definitions and distributed copies of case investigation forms and contact tracing guidelines in assessed health facilities. health facilities formed surveillance teams to heighten surveillance and active case search in order to detect any alert or suspect cases. volunteers were trained on evd screening at border poes and refugee reception centers with support from various partners. a poe coordination committee developed a poe toolkit which was approved by the ntf and adapted for use by moh. the poe teams screened everyone crossing into uganda from drc with infrared thermometers for body temperature, including all refugees at reception centers. persons found with elevated body temperatures (> degrees celsius) were further screened for ebolalike symptoms. the nrrt trained laboratory health workers on specimen collection from suspected evd cases and triple packaging for transportation to the uganda virus research institute (uvri) for testing. with support from partners, ambulances were stationed in each of the category high-risk districts for rapid transportation of specimens to the uvri viral haemorrhagic fever (vhf) program laboratory in entebbe, ensuring delivery of samples within h of collection. in addition, the moh conducted a pilot of an electronic system to track collected samples to improve the monitoring of laboratory results turnaround time. other actions undertaken in the preparedness period include modifications of the specimen collection, sample chains of custody and packing list forms. these modifications aimed to strengthen the existing biosecurity mechanisms of the national laboratory services. by end of may , ebola alerts were verified countrywide (fig. ) . although up through june, no specimen collected from an alert tested ebola positive, other vhf pathogens were detected in samples from alert cases including crimean congo haemorrhagic fever [ ] and rift valley fever [ ] . the dtfs identified clinical staff including clinicians and community health workers whom the nrrt trained on evd case definitions, transmission, clinical presentation, community surveillance, reporting, ipc, and case management including dignified safe burial. the trainings included simulation exercises such as donning and doffing of evd ppe for case management and safe burial. during the trainings, the nrrt disseminated evd guidelines and standard operating procedures (sops) for patient management and, safe and dignified burial. the nrrt also helped the dtfs to designate and setup evd isolation units at specified hospitals and health facilities ready to provide care to evd patients. with support from partners, moh constructed ten ebola treatment units (etus) at designated hospitals in highrisk districts. the nrrt conducted ipc assessments and instituted hand-washing and disinfection measures and positioned hand-washing stations at major health care facilities, official and high-risk unofficial poes, refugee transit and reception centers, and other relevant public places in the high and moderate risk districts. with support from partners, moh trained district-based ipc trainers who trained and mentored all relevant health facility workers on ipc practices in handling suspect, probable and confirmed evd patients including safe waste management, and safe dignified burials. the ntf logistics sub-committee conducted logistics assessments in at least five of the high-risk districts to determine a baseline, and then used the data for forecasting and quantification for medical, ipc, ppe, and laboratory needs for the districts. with support from the nrrt, the dtfs developed emergency contingency plans and budgets to facilitate evd preparedness activities, which were reviewed and approved by the ntf. the moh with support from partner agencies purchased and distributed ppe and other relevant supplies to all designated district hospitals and health facilities for case management. a number of development partners and international agencies supported the moh financially to avail the preparedness logistics and supplies to the districts. the ntf generated a press statement which was read by the minister of health on rd august to inform the public about the evd outbreak in drc and increase alertness for surveillance in the high-and moderaterisk districts and the rest of the country. the ntf risk communication subcommittee developed subsequent press releases for the minister of health, the committee also developed the risk communication plan, radio spot messages, reviewed, printed and translated iec materials which were translated in fifteen most spoken local languages in the high-and moderate-risk districts across the western border of uganda to ensure reach to the general public. information specified signs and symptoms of evd, the need to seek urgent medical care in case symptoms arise, and the importance of safe burial of the dead. evd information was disseminated regularly through local newspapers, popular radio, and television stations. in addition, the dtfs disseminated iec on evd through regular radio talk shows, spot messages, and posters in high-risk communities. they also supported trained community volunteers to carry out communal and door-to-door evd health education. the ntf sought ethical and institutional approval for prophylactic use of the rvsv-zebov vaccine currently used in the drc based on its demonstrated protective efficacy against the ebola virus-zaire type. this particular vaccine was being administered in drc and had demonstrated positive protective results and potency against the ebola virus-zaire type [ ] . the aim of the initial ebola vaccination campaign was to protect frontline health and non-health workers in uganda under a compassionate-use strategy to protect persons at potential risk for evd in advance of an outbreak. once approval was granted, the moh, with support from the who, secured vaccine doses, established and trained national vaccination teams, organized cold chain logistics, selected districts and mostat-risk workers in health care facilities, poes and other locations (laboratories, airport, etc.), and commenced voluntary vaccination. vaccination proceeded according to a site-by-site plan ranking highest-to lowest-risk sites for evd case introduction from the drc. the vaccination campaign planning committee used popcab results from identified districts to inform their decisions about which heath care facilities and poe to target during the initial vaccination campaign. an additional doses of vaccines were later secured to scale up the vaccination exercise. by the end of april , uganda had vaccinated health workers in high-risk districts (fig. . the vaccination team in their wisdom selected health workers they considered more at risk compared to others and targeted those for vaccination rather than vaccinate all health workers. this was the first time ebola vaccination was conducted as part of a country's preparedness response. a who joint monitoring and assessment of evd preparedness in uganda conducted in december showed significant progress, with up to % readiness nationally. the moh therefore recommended a fullscale simulation exercise to test the operational capabilities of all components of the preparedness and response plan. a full-scale simulation exercise (fsx) was conducted in april to test the preparedness and response systems at three levels of operation: community, district, and national. the exercise was conducted in a highly stressful environment, simulating actual response conditions. the exercise simulated three suspected cases of evd. the first case tested the response systems at a designated land poe in kasese district (mpondwe border point), and referral to an ebola treatment unit (etu), while the second came through entebbe international airport. the third case tested community surveillance and reception of an evd suspected case in a non-etu facility in kasese district, and subsequently safe and dignified burial when the patient died. the coordination structures at national and district levels were also tested. in all scenarios, detection of a suspected evd case was timely, though reporting from the community to the national level was delayed. the simulation exercise identified strengths and gaps in the development and implementation of preparedness and response measures. the exercise also identified areas for improvement in coordination of the response at district level, safe referral of evd suspected cases, infection prevention and control, and management of severely ill patients. it was recommended that preparedness efforts prioritize skilling health care providers through intensified supervision, mentorships and drills. the conflation of political instability and rebel activities coupled with community mistrust in the outbreak response in eastern drc have made it very difficult for the drc and its partners to control what has now become the second-largest and -longest evd outbreak recorded in history [ ] . as a result, the outbreak continues to rage on and on many months after it was declared, and the number of confirmed evd cases in the drc have been increasing, with new cases being declared closer to the ugandan border [ ] . at the same time, uganda continues to receive a large influx of people from drc through official and unofficial poes, posing a huge strain on the border screening efforts put in place. moreover, evd preparedness efforts are showing multiple signs of fatigue from all sides and is thus becoming increasingly hard to sustain, with funding and resources still inadequate to cover all high-risk districts, and yet the need to sustain the preparedness momentum at both national and district levels is greater than ever. a day after the official declaration of the th evd outbreak in the drc, uganda's moh initiated a quick evd preparedness response by activating the ntf and pheoc to a response level and mandating its members and partners to plan, mobilize resources and coordinate implementation of the full range of evd preparedness pillar activities. with support from several partner organizations, uganda was able to activate the ntf and create an active ims and a partner coordination matrix, mobilize resources and carry out preparedness activities in designated high-and moderate-risk districts on its western border with drc as well as on adjacent borders with rwanda and south sudan and the central urban hubs of kampala and entebbe, linked to population movements from and to the drc's outbreak hotspots. in addition, uganda has established multi-sectoral and multidisciplinary national and district task forces, and technical subcommittees for each preparedness pillar that advise the ntf and act as liaisons between the ntf and the high-and moderate-risk districts. these quick actions were most influenced by uganda's experiences with four previous evd outbreaks [ ] . with this experience and support from partners, activation was quick and was established with relative ease. the lasting impact of these efforts is a high likelihood that it could generate momentum towards national and partners' commitments to support long-term emergency preparedness for future outbreaks. the who recommends evd preparedness activities in countries with close proximity to evd epicenters to enable them respond should there be any importation of evd cases. uganda is among nine priority countries neighboring drc since the present th evd outbreak started [ ] . after the evd outbreak in west africa, the who proposed an agenda for changing its strategy in the face of epidemic and pandemic threats, which has been largely accepted by who member states, including uganda. through this agenda, who was able to support uganda with a quick, proactive, result-driven, resourced and well-equipped team. indeed, uganda, supported by its internationally recognized national vhf program at uvri, was the first neighboring country in the who-afro region to initiate and engage in a fully-fledged emergency preparedness and response program, which also included prophylactic use of ebola vaccination. the preparedness assessment found that all highand moderate-risk ugandan districts had less than a % score for evd readiness at baseline. it also found that the average score for evd preparedness was highest in laboratory and lowest in budgets, safe burials, and contact tracing. these findings were similar to who's initial assessments done across evd african countries neighboring drc during the evd outbreak as well as what was found by who in the evd preparedness assessment for west african countries ( ). the unhcr, iom and medical teams international (mti) that provide active health, border, and mobility care for refugees in the settlements had already put in place measures to strengthen evd preparedness such as evd trainings, evd screening, ipc measures, and dissemination of evd iec materials. following the idsr guidelines, the national surveillance system was strengthened with training of all national and district surveillance focal persons and facilitation for timely detection, reporting, and investigation of evd alerts with focus on cross-border surveillance and early patient triage at high-risk referral health care facilities. the eoc continues to provide timely information about disease epidemics while the ntf closely continues to guide, monitor, and supervise the preparedness activities. the country has built capacity and established a good laboratory network within districts, regional referral hospitals, and at the national level to collect, package, store and transport samples to the national vhf program laboratory at uvri. the vhf program laboratory at uvri is a regional diagnostic referral laboratory for vhf and routinely screens all suspect specimens for ebola (bundibugyo, sudan), marburg, cchf and rvf. there is also well-developed local capacity for social mobilisation during epidemics with engagement of political, local and religious leaders. many health workers have been trained in evd case management and provided with updated guidelines and sops with support from several partner agencies. nine months after the declaration of the th evd outbreak in the drc, uganda continues to conduct preparedness activities to prevent introduction and spread of evd into the country. while who continues to support this effort, the duration and extent of this outbreak has come as a surprise to many. as a result, governments, donors, and partners have all been stretched to a point where the preparedness strategy needs to be revisited. specifically, it is important to redefine strategies in order to both maintain the readiness momentum at a time where the risk of outbreak spillover has increased, as well as to plan for the human, technical, and financial resources needed to balance this protracted effort with the rest of the national health security agenda. this agenda requires at least equal time, efforts, and resources as evd preparedness, yet the capacity of an atrisk country like uganda is limited and cannot address both needs fully. a who meeting on strengthening partnership for improving ebola preparedness and readiness took place at the end of april and this issue was addressed. as the evd outbreak continues in drc, the risk of cross-border transmission remains imminent. subsequently, the country has plans to expand and intensify preparedness activities to additional districts, with a special focus on the use of universal precautions and ways to strengthen and sustain ipc practices at all health facilities in high-risk districts. the broad evd preparedness workgroup continues to strengthen cross-border collaboration and to engage the community in door-todoor risk communication and surveillance in all highrisk districts. there is also need to accelerate vaccination of at-risk frontline health workers in the other high-risk districts. the moh, with support from partner agencies, has started to conduct drills and simulation exercises in the most at-risk districts bordering the drc to evaluate preparedness and response capacity. the moh also plans to improve sample transportation and re-establish a national border health unit that has been inactive for many years. within the first month of declaration of the th evd outbreak in drc, uganda's moh had established a strong coordination and surveillance system to effectively alert and respond to any evd suspect case and to mitigate risk of importation of evd into uganda. with continued technical and financial support from many partners, the country has strengthened evd preparedness and timely detection, investigation and response to evd alerts. sustained efforts are required to support refreshing of health workers, provision of infection control supplies, maintenance of infrastructure, provision of equipment for case referral and isolation, regular drills and simulation exercises in key technical areas, continued risk communication, community engagement, resource mapping as well as countrywide coordination. on june , uganda detected its first cases of evd as a result of a spillover event from the drc. while the details of the cases will be presented in another paper, cases were quickly recognized, specimens safely collected and efficiently transported for diagnostic testing and confirmation at uvri. case patients were rapidly relocated to an etu for isolation and care. as of june , no secondary transmission from these three cases have occurred in uganda, a clear demonstration of the effectiveness of the uganda preparedness program. afenet: african field epidemiology network africa centres for disease control and prevention; china cdc: chinese centre for disease control and prevention; dfid: department of international development dho: district health officer; dht: district health team; drc: democratic republic of congo; drrt: district rapid response team; dtf: district task force; etu: ebola treatment unit; evd: ebola virus disease; fao: food and agriculture organisation of the united nations; fgd: focus group discussion; ghsa: global health security agenda; idi: infectious diseases institute, uganda; ihr: international health regulations; imc: incident management commander iom: international organisation for migration makerere university school of public health; moh: ministry of health mti: medical teams international; muwrp: makerere university walter reed project; nrrt: national rapid response team; ntf: national task force undp: united nations development program; unhcr: united nations high commissioner for refugees; unicef: united nations children's fund; urcs: uganda red cross society; usaid: united states agency for international development; us-cdc: united states centers for disease control and prevention; uvri: uganda virus research institute; vhf: viral haemorrhagic fever; vht: village health team; wfp: world food program; who: world health organisation organisation, country office, kampala, uganda. world health organization -afro african risk capacity, kampala, uganda. united nations children's fund, kampala, uganda. civil aviation authority, entebbe, uganda. united states agency for international development democratic republic of congo: ebola virus disease -external situation report ebola virus: symptoms, treatment, and prevention signs and symptoms | ebola hemorrhagic fever | cdc ebola vaccine to help tackle drc outbreak ebola virus disease) | cdc [internet] a systems view and lessons from the ongoing ebola virus disease (evd) outbreak in west africa outbreak of ebola virus disease in guinea: where ecology meets economy years of ebola virus disease outbreaks | - outbreak west africa | history | ebola (ebola virus disease) | cdc [internet] efficacy and effectiveness of an rvsv-vectored vaccine expressing ebola surface glycoprotein: interim results from the guinea ring vaccination cluster-randomised trial ebola virus disease) | cdc [internet] ebola viral hemorrhagic disease outbreak in west africa-lessons from uganda who-regional-strategic-evd-operational-readiness springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we thank all partners for the technical and financial support which made the country prepare for an evd outbreak. special appreciation goes to the following organisations and agencies: afenet, africa the moh/ntf undertook the planning, coordination, and implementation of the preparedness activities. jra, ara, anm, im, mn and ytw participated in design development, data collection and management, and manuscript writing. all authors offered technical assistance for data management, manuscript development and reviewed the manuscript for intellectual content. all authors contributed to the write up, read and approved the final manuscript. the evd preparedness activities were supported by the uganda ministry of health, international agencies and development partners. the data sets and the reports that support this write up belong to the moh uganda. due to confidentiality reasons, the data sets and reports are not publically available. however, the data sets and the reports could be availed upon reasonable request and with permission from the moh uganda.ethics approval and consent to participate not applicable. not applicable. the authors declare that they have no competing interests. key: cord- - klurh a authors: houtrow, amy title: addressing burnout: symptom management versus treating the cause date: - - journal: j pediatr doi: . /j.jpeds. . . sha: doc_id: cord_uid: klurh a nan over the last decade, burnout among physicians and other health care providers has received considerable attention. what is the optimal way to address what appears to be a growing pattern of burnout among pediatric providers, subject to administrative and productivity burdens, while they care for pediatric patients, who themselves often have expensive and complex, multi-system diseases? what is the best path to wellness for providers? in this volume of the journal, hente et al consider one solution. they report a pilot study of providers in the cincinnati children's hospital medical center cystic fibrosis clinic who took part in six mindfulness-based, cognitive therapy sessions in order to assess the efficacy of this therapy to reduce stress and improve provider well-being. after the intervention, participants had improvements in empathy, depersonalization, perspectivetaking, perceived stress, anxiety, negative affect, and resilience. the research team undertook this intervention due to the high risk of burnout for their interdisciplinary team. , symptoms of burnout classically include malaise, fatigue, frustration, cynicism and inefficacy. the personal, health system, and financial costs of burnout are substantial. in a baseline evaluation, prior to initiating the mindfulness intervention, the cystic fibrosis interdisciplinary team endorsed numerous stressors and scored in the average range for work-related stress. the researchers should be applauded for their use of numerous validated tools and the length of time for follow-up in this study. demonstrating sustained benefits at months is impressive. as in this pilot study, many of the efforts to address burnout focus on techniques to reduce stress or improve resilience. , mindfulness has been associated with positive impacts for health care providers, so this intervention was logical to pursue. , that said, what is more important is addressing the underlying reasons health care providers experience burnout in the first place. this approach would be akin to treating the disease itself, rather than just treating the symptoms. to treat the disease effectively, we should recognize that burnout in health care has an important cause: moral injury. , as defined by the syracuse university moral injury project, moral injury is "the damage done to one's conscience or moral compass when that person perpetrates, witnesses, or fails to prevent acts that transgress one's moral beliefs, values, or ethical codes of conduct." although much of the research in the area of moral injury is conducted with war veterans, there is a growing emphasis and a body of literature that frames the experience of health care providers in terms of moral injury. , health care providers have a fiduciary responsibility to their patients. we are taught how to advocate best for our patients' needs by uncovering disease and providing effective treatments using shared decision-making techniques. this responsibility is deeply ingrained in us, and we have given over our lives to this work. when health care providers cannot act in accordance with our moral obligations to our patients, profound psychological distress can result. , it is morally distressing, for example, to have increasing clinical productivity standards coupled with additional administrative tasks that infringe upon the patient-provider relationship. repeatedly, health care providers face circumstances when they cannot provide optimal care because of a malalignment with the values and objectives of the health care environment in which they work. symptom interventions, such as mindfulness training, are valuable and can play an important role in the management of clinician distress, but a shift to addressing the root causes is truly necessary. focusing on burnout suggests that the health care provider has the problem and that the locus of intervention should be at the provider level. the implication is that health care providers who experience burnout (over half of us) are not mindful enough or not resilient enough. , , it may seem insulting to many health care providers to be told that their distress is their weakness and that their symptoms can be adequately addressed with meditation or mindfulness. it should be distressing when care of patients is hindered by increasing work expectations make providing that care effectively nearly impossible. health care providers are in a double bind that no amount of "goat yoga" will fix. of course, working day in and day out under unfavorable circumstances severely challenges our ability to fulfill their ethical commitments to provide the best care. in the immediate short term, we should that the moral injury crisis in health care will worsen. in light of the covid- pandemic, health care workers have faced knowing that they must do what they can with limited and depleted resources. the basic essence of moral injury for a health care provider is going against what is known to be the right and just thing to do because of circumstances beyond their control. we have seen this moral injury play out in real time during this pandemic. , , health care providers are putting their own health (and subsequently their families' health) at risk when treating patients without proper personal protective equipment. health care providers are overwhelmed while watching patients struggle and having so little to offer them. health care providers are emotionally exhausted holding the hands of dying patients without their family members at the bedside because of the infection risk. health care workers suffer when the public health response is inadequate. the souls of health care providers are hurt when capacity is exceeded and people die because of it. looking toward a future when covid- looms less large, it will be imperative to focus on fixing what is broken in the way we deliver health care. optimizing population health and the health of individual patients will require attending to the misaligned goals of health care providers, health insurers, hospital administrators, regulators, and the public. in the realignment of health care, patients' needs should be the top priority and everything that does not facilitate the achievement of improving the health, functioning, and well-being of patients and populations should reconsidered. although mindfulness practices, relaxation techniques, exercise, and the like will still have a role in the management of burnout, what we really need is collective action to promote clinician well-being that helps health care providers carry out their lives' work--to provide the best possible care to the patients and communities whom we serve. association between physician burnout and patient safety, professionalism, and patient satisfaction: a systematic review and metaanalysis beyond burnout -redesigning care to restore meaning and sanity for physicians the staff burn-out syndrome in alternative institutions estimating the attributable cost of physician burnout in the united states a mindfulness course decreases burnout and improves wellbeing among healthcare providers the impact of mindfulness-based interventions on doctors' well-being and performance: a systematic review systematic review of mindfulness practice for reducing job burnout clarifying the language of clinician distress the moral injury project reframing clinician distress: moral injury not burnout covid- and experiences of moral injury in front-line key workers the toughest triage -allocating ventilators in a pandemic to care is human -collectively confronting the clinician-burnout crisis changes in burnout and satisfaction with work-life balance in physicians and the general us working population between clinician wellness during the covid- pandemic: extraordinary times and unusual challenges for the allergist/immunologist supporting the health care workforce during the covid- global epidemic key: cord- - bnj s authors: blouin, chantal; dubé, laurette title: global health diplomacy for obesity prevention: lessons from tobacco control date: - - journal: j public health policy doi: . /jphp. . sha: doc_id: cord_uid: bnj s to date the global health diplomacy agenda has focused primarily on infectious diseases. policymakers have not dedicated the same level of attention to chronic diseases, despite their rising contribution to the global burden of disease. negotiation of the framework convention on tobacco control provides an apt example from global health diplomacy to tackle diet-related chronic diseases. what lessons can be learned from this experience for preventing obesity? this article looks at why a global policy response is necessary, at the actors and interests involved in the negotiations, and at the forum for diplomacy. global health diplomacy involves new forms of collective action and negotiation of new rules and norms to address global health challenges. traditionally, nation states have dominated these processes, having negotiated internationally to address cross-border health risks since the mid-nineteenth century. today a diverse group of other non-state actors participate, impelled by the increasing impact of globalisation on health systems and population health. given the more immediate interdependence and stronger cross-border linkages associated with epidemics, the global health diplomacy agenda remains focused on infectious diseases, virus sample sharing, pandemic flu , and sars. with such diseases, the ability of one country to protect the health of its population can directly depend on whether another country has the capacity to detect and respond to mobile, readily transmissible communicable pathogens, and vice versa. y by contrast [to such interdependence], interconnectedness does not involve relationships of mutual dependence among states and, thus, does not provide robust incentives for reciprocal undertakings to lower risks. in global health, interconnectedness is often a feature of non-communicable disease problems. for example, the export by a developed country of processed foods high in added sugars and salts may contribute to the prevalence of childhood or adult obesity in a developing country, but the health, security, and economic well-being of people in the developed country do not depend on whether the developing country controls and reduces the prevalence of obesity in its territory. as emphasis on infectious diseases continues, we concentrate here on an example of global health diplomacy to tackle chronic diseases: the framework convention on tobacco control (fctc). in , a technical group of the world health organization (who) recommended that the who 'take the lead in the development of an international code on the commercial promotion of food and beverages to children' (p. ) to address the rise of obesity in children globally. in anticipation of these negotiations over the global marketing of food to children, we analyse lessons learned from the fctc for use in diplomatic efforts to prevent diet-related chronic diseases. the fctc is a treaty negotiated among member states of the who during the years - . it took effect on february ; by november , the signatory countries numbered . with more than five million tobacco-related deaths per year, tobacco use is the single most preventable cause of death in the world. the fctc countries committed themselves to raising taxes on tobacco products, regulating packaging and labelling of tobacco products, banning tobacco advertising and promotion, and installing measures to reduce illicit trade in tobacco products and sales to minors. the treaty does not offer a blueprint for the elimination of tobacco use or for the banning of international trade in tobacco products; instead it creates an international legal framework for collective action on tobacco control. to examine the negotiation of this treaty, we use a simple analytical framework identifying ( ) the specific problem requiring cross-border collective action, ( ) the key actors, ( ) their interests and 'stake' in this problem, ( ) the potential forum or process for negotiations and ( ) the potential scenarios for collective action. we conducted this exercise based on secondary literature. we discuss lessons to be learned from the negotiations of the fctc for potential applicability to diet-related chronic disease prevention, and, more specifically, the rise in obesity prevalence worldwide. the problem of increasing obesity shares some characteristics with both previous examples, infectious diseases and tobacco; there are also some important differences. although national policies can often be effectively implemented without international collaboration, the globalisation of marketing strategies of the tobacco industry has rendered these insufficient. 'advertising and smuggling do not stop at national borders' (brundtland, p. ). trade liberalisation, including reduction in trade barriers for tobacco products, has facilitated market access for tobacco companies and contributed to increasing tobacco use in many developing countries. two decades of bilateral, regional and multilateral trade agreements adopted by many nations engendered significantly greater competition in domestic tobacco marketsaccompanied by reduced prices for tobacco products and dramatic increases in the advertising and promotion of these products. , growing numbers of investment protection treaties have facilitated international industry in establishing its presence and expanding marketing of foreign products to capture local markets. signatories of these treaties are expected to decrease restrictions on the entry and operation of foreign investments and protect them against adverse government regulations. multinational tobacco companies undermine the regulatory authority of national governments through public relations and lobbying strategies. this problem is especially acute in developing countries, given the asymmetry of resources between large global tobacco companies and the governments of small countries. problems addressed by global health diplomacy for tobacco control do not involve great interdependence among nations, creating 'a weaker foundation for diplomatic action' (fidler, p. ). high levels of tobacco-related disease in one country do not directly affect the health of the citizens of another. thus, global health diplomacy on issues of lesser interdependence is more arduous than in instances where countries directly feel the impact of the actions (or inaction) of their neighbours. who member states were able to come to an agreement on tobacco control, and therefore it is possible that other factors, including common challenges for regulating the industry, can provide sufficient impetus for success in global health diplomacy for chronic disease prevention. many participants engaged in negotiating the fctc, including the who itself as a 'policy entrepreneur' secretariat, while promoting collective actions at the global level. the who also ensured the support and collaboration of the world bank and other united nations agencies. national governments remained central actors, with their ministries (trade, foreign policy, finance, taxation, customs and development working with health) adding multi-sectoral dimensions to the collaboration. the active role of developing countries in shaping the treaty stimulated progress toward the agreement. regional coalitions of countries, including one formed by the delegates from africa, strengthened their negotiating positions. highincome countries, including the united states, japan and germany, boldly advocated a minimalist fctc. what has been the role of the tobacco industry in the negotiations of the fctc? it was not united in opposition to stringent regulation. [t]he strategic responses to emergent regulation adopted by tobacco companies diverged significantly according to their respective market status. y [for instance] bat was at the forefront of industry hostility to the who's approach, as might be predicted given that its comparative commercial strengths lie in developing regions where accelerated regulation would be expected to have the greatest impact. (collin and lee, pp. - ) pharmaceutical companies were also party to these negotiations. with the who they explored how nicotine replacement treatments could be made more widely available. non-governmental organisations took part, both as observers of the negotiating sessions and as advocates who pressured governments and others key actors to adopt strong tobacco control provisions. the framework convention alliance, comprising nearly organisations from over countries, emerged as the key non-government actor to support the signing, ratification and implementation of the fctc. the wide membership increased the likelihood that most of the delegations in geneva would be pressured at home to adopt strong tobacco control provisions and to promote these actively throughout the negotiations. in contrast to other issues in global health diplomacy, in tobacco control commercial interests are very clear: measures to limit tobacco use would reduce the market and profits. although markets had already stagnated and decreased in industrial countries, rapid growth of tobacco use in developing countries meant that a global treaty would threaten tobacco companies operating in these new and dynamic markets. some firms demonstrated their opposition to the treaty by mounting a lobbying campaign against it and systematically searched for allies within governments. other firms attempted to focus discussion on the few issues on which common ground could be found, for example how to limit underage use. fidler distinguishes a transformative approach to global health diplomacy from an instrumental one. the motivation for the first is the 'possibility of centering international relations on health as the normative engine of political cooperation and progress'; for the second, participants attempt 'to use health instrumentally to achieve other foreign policy and diplomatic goals' (fidler, p. ). while the global health activists in ngos adopted a transformative approach, the national governments adopt strategies where both approaches co-exist. ministries of public health generally sought support for strong tobacco control measures, taking the transformative approach. but in their efforts to organise inter-sectoral collaboration among stronger domestic institutions including law enforcement or finance, health ministries often pursued international collaboration for instrumental reasons -to strengthen their positions nationally. similarly, the who used the fctc negotiations to attack tobacco-related health threats as well as to re-establish its status and credibility among un agencies after years of decline under weak management without clear vision; tobacco control became part of the strategy to reposition the organisation as a 'department of consequence'. a who initiative was to host the fctc negotiations at its geneva headquarters. although the who possessed treaty-making powers since its inception, it had never exerted these, instead using its power to adopt international regulations and non-binding resolutions. the fctc reflects influence from the framework-protocol approach often used in international environmental law, where the 'states agree to a framework treaty that contains only general obligations but establishes the diplomatic machinery that will push the legal regime to more specificity and effectiveness' (fidler, p. ). thus, the framework convention on tobacco control sets obligations for signatories whose members commit to continuing negotiations within the context of specific protocols. accordingly, in the who hosted the first session of the intergovernmental negotiating body on a protocol on illicit trade in tobacco. although negotiations of the fctc remain in the tradition of the state-centric approach and forum to address global health challenges, they involve some newer multi-actor and multi-level interactions. in addition to their very active campaigning, some nongovernmental organisations came to be recognised participants in negotiations along with state delegations. to address the problems related to global marketing and advertising of tobacco products and the pressure from multinationals on national governments to curb regulatory actions, the who and its member governments, supported by a number of non-governmental actors, promoted the development of a multilateral treaty. this committed them to tobacco control measures on price and taxes, exposure to environmental tobacco smoke, package and labelling requirements, product content, educational campaigns, restrictions on advertising, sponsorships and promotion, clinical intervention, subsidies and agricultural policies, and restrictions on youth access to tobacco and liability. these are domestic policies to be implemented at the national level. why, then, were international negotiations needed to achieve such policy outcomes? the international commitments changed domestic political dynamics. the adoption and implementation of tobacco control measures strengthened the positions of public health advocates vis-à -vis pressure from multinational tobacco companies. moreover, the treaty addressed the impact of globalisation of marketing and advertising of tobacco. once all signatory governments agreed to restrict advertising and marketing of tobacco products, the treaty overcame the limitation of previously divergent national policies. the fctc differs from previous treaties as it does not address problems between countries. rather, it tackles problems that all countries share. some have suggested that treaty negotiations on national regulations to promote healthy diets would not be so different from the experience with tobacco control. an important consideration is the extent of interdependence among nations as a key incentive for cross-border collaboration. what other incentives will lead national governments and other actors to pursue collective actions globally (or regionally)? strengthening the position of national regulators and public health agencies to take on wellorganised lobbying became an incentive for cross-border collaboration. liberal policies on tobacco marketing in one country or lax enforcement of anti-smuggling law could impact tobacco use in another country. adoption of trade liberalisation and international trade agreements that have had a direct impact on tobacco availability and use, especially in developing countries, also involved interdependence. the fctc does not fully address this issue; although tension between trade liberalisation and tobacco control was evident in negotiations, the final text is silent on precedence of international trade law over the fctc. it will be useful to study this further given the importance of international trade agreements for healthy diets. although fctc negotiations led to a multilateral treaty under the aegis of the who, those pursuing obesity reduction should not focus too narrowly on this specific forum. a key impact of fctc negotiations lies outside the formal treaty: global networking among public health advocates inside and outside government and the diffusion of policies. following intense international interactions on experiences with tobacco control policies, countries accelerated the adoption of new measures. as collin and lee observe, national policy development and fctc negotiations clearly interacted. once canada adopted large graphic health warnings, thailand, brazil and the european union replicated them. important impacts of the recent global health diplomacy on tobacco control include global mobilisation of civil society in support of the fctc and the rise of a large coalition, the framework convention alliance. what are the lessons we can draw from the experience of global diplomacy on tobacco control for obesity and diet-related chronic disease prevention? first, which actors need to be involved in the process? political leadership, strong mobilisation and advocacy from well-organised groups globally are crucial in triggering and sustaining a global policy response such as an international treaty. whether a critical mass of political capital is available at this point in the area of diet and nutrition remains to be seen. second, global health diplomacy on obesity will require a much stronger engagement with developing countries. many of these countries perceive the discussions as more relevant to industrial countries despite the rapid growth of obesity in emerging and middle-income developing countries. with regard to diet and nutrition, the needs and concerns of developing countries will be more complex [than in tobacco control y]. the goal should be to promote the optimal diets for all. it also requires that greater attention be paid to the complex agricultural and economic issues related to subsidies and decisions about what is cultivated. such concerns would need to be well integrated in the agenda to assure inclusion of developing country interests in the negotiations. third, we highlight the importance of a multi-sectoral approach, engaging a wide range of actors outside the health sector, including commercial ones. some may provide leadership. a diverse group of businesses produce, process, distribute, market and sell food and drinks. for tobacco control, the ultimate public health goal is elimination of the industry. obviously the food industry plays an essential role, and the policy 'end game' for chronic diseases is transformation to a health-oriented food system, not the extinction of the industry or many of its activities. as interests of some food industry actors (industries dealing in fresh fruits and vegetables) merge with those promoting global public policies for healthier diets, meaningful collaboration against obesity is likely to be easier to achieve. the fourth and final lesson relates to the forum for discussion and negotiation. the literature reveals different perspectives. some representatives from the food industry object to the fctc model, as an international treaty entails an adversarial approach that would be counterproductive: in many ways you could say the tobacco convention has laid out for the public health sector a road map which we should not follow for food. we should be doing almost the opposite. instead of shaming and blaming we need to find ways of working with the industry. others suggest that the fctc precedent, a binding international treaty, would provide a useful tool for regulating the food industry, especially for snack foods, sodas, fast foods and prepared foods that to blame for the great increase in obesity. they remain sceptical about the possibility of productive collaboration with commercial actors given the ways in which interests diverge. another argument made in favour of the fctc approach is the power of multilateral negotiations to mobilise groups to act nationally and locally and to increase the exchange of policy innovation. emily lee suggested that motivation to adopt the framework-convention model involving an incremental approach to standard-setting, instead of one single detailed treaty for tobacco control, derived from anticipation of strong opposition from the tobacco industry. she also argued that the rationale applies in this case to obesity, and once again this incremental approach will be more likely to succeed. based on these lessons, we conclude that global health diplomacy for obesity prevention requires a much higher level of mobilisation of political leaders, civil society organisations, governments and non-state actors in developing countries, and engagement with the many private actors in the agri-food industries before healthy diet proponents are ready to negotiate a treaty similar to the fctc. in order to progress as rapidly as possible, future analytical work should identify what issues could be more easily tackled in a collaborative manner, and for which issues regulation and a treaty would be the most effective instruments. given that marketing of food to children is already on the global diplomatic agenda, researchers may want to focus on this. we draw a fifth and final lesson -beyond selection of an instrument or a forum for negotiations -on the importance of the process itself. preparation for negotiations, mobilisation of civil society organisations, dialogue with industry, consultation with experts, and sharing of information among national health agencies are all necessary steps leading to negotiations. this process itself can foster the adoption of pro-health policies at the local, national, regional and global level. ongoing discussions around a who code on the marketing of food to children are not yet taking place in the context of formal, multilateral negotiations, but they may already be influencing discourse and practices for tackling childhood obesity. investing in these pre-negotiation exercises is an integral part of global health diplomacy for obesity prevention. the globalization of public health: the first years of international health diplomacy trade policy and health: from conflicting interests to policy coherence influenza virus samples, international law, and global health diplomacy avian and pandemic influenza: progress and problems with global health governance pandemic influenza: public health preparedness for the next global health emergency global surveillance, national surveillance, and sars forthcoming) health in foreign policy: an analytical overview preventing chronic diseases: how many lives can be saved? marketing of food and non-alcoholic beverages to children navigating the global health terrain: preliminary considerations on mapping global health diplomacy. world health organization globalization, trade, and health working paper series achieving worldwide tobacco control the demand for cigarettes in taiwan: domestic versus imported cigarettes. nankang, taipei: the institute of economics impact of american cigarette advertising on imported cigarette consumption in osaka building a national strategy on trade and health global change and health: mapping the challenges of global non-healthcare influences on health the framework convention on tobacco control: the politics of global health governance the framework convention on tobacco control: promising start, uncertain future globalization and the politics of health governance: the framework convention on tobacco control global health governance: a conceptual review. centre on global change and health, london school of hygiene and tropical medicine and who the development of international health policies -accountability intact? lessons from tobacco control for the obesity control movement the economics of tobacco control: towards an optimal policy mix ( ) trade, food, diet and health: perspectives and policy options improving diet and physical activity: lessons from controlling tobacco smoking heath challenge think tank ways forward toward 'health-friendly' local and global food chains to fight childhood obesity the world health organization global strategy on diet, physical activity, and health turning strategy into action the authors acknowledge the financial support of the who collaborating centre on non-communicable disease policy at the public health agency of canada. key: cord- - euy u k authors: wang, yadong; li, xiangrui; yuan, yiwen; patel, mahomed s. title: a multi-method approach to curriculum development for in-service training in china’s newly established health emergency response offices date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: euy u k objective: to describe an innovative approach for developing and implementing an in-service curriculum in china for staff of the newly established health emergency response offices (heros), and that is generalisable to other settings. methods: the multi-method training needs assessment included reviews of the competency domains needed to implement the international health regulations ( ) as well as china’s policies and emergency regulations. the review, iterative interviews and workshops with experts in government, academia, the military, and with hero staff were reviewed critically by an expert technical advisory panel. findings: over participants contributed to curriculum development. of the competency domains identified as essential for hero staff, nine were developed into priority in-service training modules to be conducted over . weeks. experts from academia and experienced practitioners prepared and delivered each module through lectures followed by interactive problem-solving exercises and desktop simulations to help trainees apply, experiment with, and consolidate newly acquired knowledge and skills. conclusion: this study adds to the emerging literature on china’s enduring efforts to strengthen its emergency response capabilities since the outbreak of sars in . the multi-method approach to curriculum development in partnership with senior policy-makers, researchers, and experienced practitioners can be applied in other settings to ensure training is responsive and customized to local needs, resources and priorities. ongoing curriculum development should reflect international standards and be coupled with the development of appropriate performance support systems at the workplace for motivating staff to apply their newly acquired knowledge and skills effectively and creatively. the outbreak of severe acute respiratory syndrome (sars) in was a watershed moment for china [ ] . it triggered major health reforms [ ± ] and led to an increase in public health funding of about % by , accounting for a rise in spending from . % to . % of the gross domestic product [ ] . subsequent emergencies that echoed the imperative for reforms included the outbreaks of influenza h n in birds and humans [ ± ] , melamine contamination of milk formula that affected over , chinese children [ ] , and the earthquake in sichuan that resulted in over deaths, displaced about million people and led to the mobilization of over medical workers [ ] . the reforms to strengthen china's emergency preparedness and response capabilities included new laws and regulations [ ± ], increased support for training and research, and the adoption of international best practice [ ± , ] . to help implement the new laws, health emergency response offices (hero) were established within china's health administration units at the national, provincial and municipal levels, in centers for disease control (cdc) and in tertiary hospitals [ ] . the heros within any one province now collectively employ around staff members, and their role is to help develop and coordinate preparedness planning and emergency response within their jurisdictions, as well as implement the international health regulations ( ) (ihr) [ ] . however, because staff members were recruited opportunistically from diverse professional backgrounds into the newly established heros, they had not been trained systematically in emergency preparedness and response previously. while they received in-service training, this was offered in an ad hoc manner, was not preceded by a needs assessment [ ] , and was aimed primarily at improving knowledge of the new laws that did not translate directly into strengthening performance of the heros [ , ] . at the global level, perennial threats of the pandemic spread of infectious diseases like sars and influenza, as well as the sequelae of earthquakes, tsunamis, bioterrorism and complex humanitarian emergencies, heightened awareness of the need to strengthen national, regional and global capacity in prevention, preparedness and response to public health emergencies. in , the world association for disaster and emergency medicine (wadem) proposed a framework for disaster health to facilitate the development of educational programs in the field [ ] . efforts were directed at identifying and defining criteria for assessing disaster health-related competencies, standards for guiding curricular development, and exploring the methods, duration and desired outcomes of training [ ± ]. australia for example, developed a national framework for disaster health education to provide guidance for educators to achieve a standardized and integrated approach across the country [ ] . australia adapted the wadem recommendations to target seven educational levels, and outlined the curricular contents and outcomes for each level; the seven levels were defined as ) informing the community, ) raising awareness of health workers, ) providing basic knowledge and skills for health workers, ) advancing the knowledge of health workers who play lead roles in disaster management, ) enhancing expert knowledge among a small group of health workers, ) targeting specialist level amongst a small group of individuals, and ) encouraging research and innovation to further develop the knowledge base of disaster health [ ] . in recognition of the national need for an in-service program to target the``level four'' health staff as defined by wadem, i.e.`h ealth workers who played lead roles in disaster health management'' [ ] , china's ministry of health (moh) commissioned the capital medical university in to develop and implement a competency-based curriculum to help strengthen the performance of the new cadre of hero staff. an immediate priority was to address the who requirements for countries to meet the core capacity requirements for implementing the ihr by june [ ] . this paper outlines the consultative process used to conduct the training needs assessment and develop the curriculum for implementation across china, with support from who. the multi-method approach to curriculum development can be applied in other settings to ensure training is responsive and customized to local needs, resources and priorities. we did not submit the study proposal for ethics approval because we conducted meetings and interviews with study informants on a voluntary basis for the sole purpose of identifying training needs at the workplace; we did not gather any personal information or attributes about individual informants beyond their age and past work experience. figure outlines the approach for developing the in-service curriculum using addie as the basic framework for instructional design [ ] . each of the five phases of this model ± assessment, design, development, implementation, and evaluation ± were reviewed critically by a technical advisory panel (tap). the panel offered suggestions for strengthening the curriculum development process, as well as the content, relevance and quality of the curriculum. the multi-method training needs assessment and subsequent steps of the addie model are detailed below. we defined a competency as``a cluster or related knowledge, skills, and attitudes that reflects a major portion of one's job (a role or responsibility), that correlates with performance on the job, that can be measured with well-accepted standards, and that can be improved with training and development'' [ ] . a competency domain incorporated an inter-related group of competencies for performing specified tasks. in order to identify the list of competency domains against which training needs of hero staff could be assessed, we collated data from three sets of references. the first was from the ihr core capacities necessary to detect, assess, report and respond to emergencies [ ] . the second set of references was from interrelated chinese laws and regulations: the emergency response law which is the legal framework for managing emergencies [ ] , the national health emergency training outline which identifies the knowledge and skills to be targeted by training programs [ ] , and the regulations on preparedness for and response to emerging public health hazards which outlines preparedness and response activities [ , ] . the final set of references was selected from chinese publications on general guidelines for training health workers [ ] and from curricula for training technical staff based in disease surveillance units, laboratories and the environmental health sector [ ± , ± ]. we assessed tasks, roles and responsibilities, and training needs of hero staff through face-to-face interviews of eleven experienced key informants; they included health emergency experts from the government, the military and the academic sector, and senior staff of heros. we also explored their awareness of existing training activities and the associated relative strengths and weaknesses, their preferences on modes of curriculum delivery and the optimal duration of in-service training. we collected data on the same issues through self-administered questionnaires to a group of hero staff members from across china when they attended a training workshop in beijing. china's ministry of health (moh) appointed a technical advisory panel (tap) to critically review and offer comments and suggestions on all aspects of the needs assessment and curriculum development process, as well as on the relevance and quality of the curriculum. the eight panel members were nationally acknowledged experts in public health emergencies from the moh, cdcs, heros and the academy of military medical science. we used the results of the needs assessment to design the draft curriculum that included the topics listed in figure . each of the identified competency domains was targeted through a selfcontained module that could be run independently of the other modules. each module encompassed theories, laws, concepts and tools and techniques essential for hero staff to perform effectively in their work. we developed questionnaires for hero staff to invite their comments and suggestions on the curriculum design, and the expected level of need and potential demand for the training. the questionnaires were disseminated with the draft curriculum to hero staff members at the provincial and municipal levels and health staff responsible for responding to emergencies at the local level. we also invited comments on the curriculum from the technical advisory panel and staff of the who office in china. we used their feedback to revise the draft curriculum. the revised curriculum was endorsed by the technical advisory panel and the ministry of health before it was implemented, monitored and evaluated between june and november . the key tasks of hero staff in their respective jurisdictions were identified as coordination of the development and implementation of preparedness plans and early warning surveillance systems, mobilization of emergency response teams, and implementation of the ihr [ ] . the list of competency domains associated with these tasks is shown in table . domains to were transcribed from both the ihr [ , ] and the chinese references [ , , ] . domains to were explicit only in the latter set of references; although implicit in the ihr capacities, study respondents suggested they be considered as discrete competency domains. of the health professionals to whom questionnaires were distributed, ( . %) responded with comments and suggestions; selected characteristics of these respondents are summarized in table . of the respondents, just under two-thirds were aged years and over, % had worked previously as clinical practitioners, % as preventive health (public health) practitioners, and % as health administrators. overall, % had less than years experience in emergency response work. the major weaknesses the respondents, key informants and the technical advisory panel identified in existing training programs were the didactic methods used for classroom teaching and the emphasis on hazard-specific approaches (such as for responding to sars or pandemic influenza or earthquakes), and on acquiring knowledge of the new laws and regulations rather than on addressing the challenges to their implementation. furthermore, while training programs in the past had targeted knowledge and skills required by technical staff such as epidemiologists, laboratory scientists and environmental staff, they had not incorporated skills in mobilizing, managing and coordinating teams across multiple sectors, disciplines and agencies. the respondents stressed the need for adopting interactive learning methods and problemsolving exercises in the classroom, as had been suggested in chinese publications [ ± ]. they supported replacing thè hazard-specific' approach with the`all hazards' approach to managing emergencies, development of a competency-based curriculum with modules that addressed specific sets of competency domains, and limiting the duration of in-service training to about to weeks so these interfered minimally with trainees' regular work responsibilities. after discussions with the key informants and tap, of the competency domains shown in table were to be developed into the individual modules shown in table . they included six of the eight ihr-related competencies, while the remaining two, national legislation' and`national co-ordination' were omitted because they were directed mainly at national-level decisionmakers. the other five domains were specified in the chinese references, namely on-site organization during response, decisionmaking processes for alerting the community, resource management and stockpiling, risk assessment and management, and evaluation of response to emergencies. the remaining seven domains shown in table were not developed into modules because they were considered to be a lower priority for health managers and could not be included in the first round of in-service training to be conducted over a limited ± week timeframe. the proportion of the respondents who expressed a high level of need for these modules are shown in table . case studies and desktop simulation exercise were both ranked as the preferred training method by % of respondents, followed by lectures ( %) and case studies ( %). the median preferred time for each module was . days. to accommodate this request and complete the course within weeks, we included only nine . laboratory [ , , ] domains not explicit in the ihr core capacities . health promotion and community education [ ] . resource management and stockpiling [ , , ] . risk assessment and management [ , , ] . monitoring compliance with laws and regulations [ , ] . decision-making processes for alerting the community [ , ] . medical rescue [ ] . on-site organization during response [ , ] . managing recovery after an emergency [ , , ] . evaluation of response to emergencies [ , ] . research on emergencies [ ] doi: . /journal.pone. .t modules, and excluded modules for two domains considered not to be priorities for heros: human resources and laboratory. the curriculum was revised to incorporate feedback from the stakeholders. two trainers prepared each module to be run over to . days; one was typically a university academic with nationally acknowledged expertise in emergencies, and the other, a senior staff member of a hero. each module would be delivered through three sessions: a lecture on relevant theories, concepts and tools and techniques that were followed by a case study and a desktop simulation exercise; the latter two sessions were conducted with small groups of to participants as an opportunity to apply, experiment with, and consolidate the knowledge acquired from the lectures. before the course, trainees were to be provided with readings for each module, and invited to prepare appropriate material from their workplace for a case study relevant to at least one module; this could include a preparedness plan, report on a risk assessment, a risk communication plan, or other reports on an emergency event. the trainers then prepared case studies either from the participants' material, or designed them de novo based on their own experiences. an example of the former was a case study based on a jurisdictional preparedness plan and where participants had to identify strengths, weaknesses and contentious issues, and to explore alternative options in the light of the newly acquired knowledge from the lectures. on returning home, they were expected to review and revise their jurisdictional plan using a similar learning approach with their local team members. an example of a case study designed by the facilitator was the assessment and management of the risk of an infectious disease outbreak at a conference attended by about international participants. each small group would then be expected to present a minute report for further discussions at a plenary, with a synthesis of key learning points. an example of a desktop simulation exercise developed by the facilitator was an earthquake scenario where participants had to convene a national response team, to mobilize them within a safe operational base near the affected zone, and then arrange the logistics for transporting and storing essential medical supplies and equipment. each small group would prepare and submit written responses to the evolving scenario to which they would receive feedback from the facilitators. the delivery of the modules was to be monitored to document attendance of trainers and trainees, the content of the training materials and the mode of delivery of each module. the evaluation plan was derived from the four kirkpatrick levels of evaluation [ ] ; the first two levels,`reaction' to the learning content and environment and`learning' (or acquisition of new knowledge) were both assessed immediately after each module. the next two levels,`behavior' at the workplace and`results' (or the benefits of change in behavior at the workplace) were assessed three months later. the results of the needs assessment and curriculum were presented, debated and finalized at a workshop with key informants, tap members and senior hero staff. the first in-service course was delivered to a class of hero staff members from provinces across china; each participant had at least one undergraduate degree and over two-year's work experience in emergency response. the monitoring and evaluations activities were implemented as planned, and the results will be published separately. this study on developing an in-service curriculum for new professional cadre of hero staff from across the country adds to the literature on china's health reforms and enduring efforts to strengthen emergency response capabilities following on the sars outbreak and other emergencies [ ± ] . it describes the multimethod approach used to identify training needs systematically, and to adopt international best practice in partnership with senior decision-makers and content experts from the government, academia and the military. the study revealed the overwhelming need to replace didactic teaching, the classical method used across china, with active learning and training methods. the consultative process for developing the curriculum was designed to address the scale of the challenge for coordinating planning and training activities across jurisdictions that cover a population of over . billion people, and where most provinces have more than million residents. the process required active engagement with experts in government, academia and the military, as well as inputs from immediate potential beneficiaries. the expert technical advisory panel played a critical role through each step in the addie model, and endorsed the curriculum development process as well as the contents of the curriculum. the ihr ( ) core capacities are aimed at minimizing the international impact of communicable disease emergencies and chemical, radiation and nuclear accidents [ , ] . however, they are also essential for timely and effective detection of, and responses to, the emerging threat at its source. china's reforms to strengthen preparedness and response capabilities [ ± , ± ] therefore incorporated the ihr core capacities as well as the competency domains identified as priorities based on china's recent experiences with emergencies [ ± ]. the overwhelming rejection of didactic teaching methods by the study respondents and the need to replace these with active learning and teaching methods was encouraging news for the curriculum designers. this approach is consistent with the two chinese symbols that depict``learning'' (f`: xue  xõ Â) -`acquisition of knowledge' and`repeated practice' as inseparable sides of the one coin. training aimed at strengthening performance has to create opportunities for active learning and experimentation with problem solving exercises to apply and consolidate newly acquired knowledge and skills. the curriculum marks the beginning of a new journey for strengthening the performance of the recently established heros in jurisdictions across china. this initial effort focused strongly on meeting the who requirements for developing the core capacities required to implement the ihr [ ] , and in particular, to strengthen the competencies of the``level four'' health staff [ ] who play lead roles in emergency planning and management. our approach for identifying and developing competencies and standards are consistent with those published by wadem in [ , ] , and in many ways resemble those used in australia [ ] . the initial list of competency domains were derived from the eight core capacities required to implement the ihr [ ] and the disaster management cycle of prevention, preparedness, response and recovery [ ] , both of which are embedded in chinese laws and regulations [ ± ] . the scope of the task and all aspects of the needs assessment and identification of the competencies were developed through iterative inputs from subject matter experts in the ministry of health, academia and the military. the mode of curriculum delivery was based on blended learning methods implicit in bloom's taxonomy as outlined in the australian framework [ ] . the duration of training for the level four workers in australia is recommended for hours [ ] ; by contrast, our course was conducted over hours because the target group had received little training in the past and included workers with diverse sets of past experience. however, consistent with the wadem guidelines [ ± ], china needs to reconcile its curriculum with international standards and expand its efforts to develop and standardize training frameworks for the other six wadem levels [ ] , as well as interconnect with the``crosscutting'' competencies of workers from the other disciplines that participate in emergency responses [ ] . adopting the international standards and practice will also enhance communications, inter-agency cooperation and inter-operability across china's national borders. the major limitation of our training is that it helps develop only the knowledge, skills and attitudes essential for working in the field of emergency preparedness and response. we recognize that training constitutes but one component of a package of activities needed to strengthen the performance of hero staff. training must be linked with an appropriate performance support system [ ] that motivates staff to apply the newly acquired knowledge and skills, and in this way, to start contributing effectively and creatively to the workplace. the support system includes a congenial work environment; explicit guidelines, supervision as well as feedback on the quality of their performance; appropriate resources such as materials, equipment and computer software; and incentives such as financial and non-financial rewards for good performance as well as opportunities for career development [ ] . the multi-method approach to curriculum development by engaging actively with senior policy-makers, researchers, and experienced practitioners can be applied in other country settings to ensure training is responsive and customized to local training needs, resources and priorities. china's engagement with global health diplomacy: was sars a watershed communicable disease control in china: from mao to now progress in tuberculosis control and the evolving public-health system in china emergence and control of infectious diseases in china melamine and the global implications of food contamination emergency medical rescue efforts after a major earthquake: lessons from the wenchuan earthquake order of the president of the people's republic of china national emergency plan for responding to public health emergencies order of the state council of the people's republic of china regulations on preparedness for and response to emergent public health hazard ministry of health of the people's republic of china the major points of work to health emergency office in fifty-eighth world health assembly resolution wha . : revision of the international health regulations assessment of capacity for logistics investigation and analysis on current status of emergency training to staffs of centers for disease control and prevention in heilongjiang province chinese health economics : ± the current situation and development of emergency management training system in china china emergency management : ± international guidelines and standards for education and training to reduce the consequences of events that may threaten the health status of a community white paper on identifying and assessing competencies in disaster health world association for disaster and emergency medicine white paper on setting standards for selecting a curriculum in disaster health world association for disaster and emergency medicine a national framework for disaster health education in australia ihr monitoring framework: checklist and indicators for monitoring progress in the development of ihr core capacities in states parties. who designing effective instruction the quest for competence beijing: china financial & economic publishing house investigation on demand for public health emergency system of health workers in guangzhou evaluating the effectiveness of an emergency preparedness training programme for public health staff in china improving emergency preparedness capability of rural public health personnel in china the survey on china adult teaching mode study in recent twenty years adult teaching methods and patterns evaluating training programs: the four levels san francisso: berrett updating the behavior engineering model key: cord- -ie xisg authors: zhong, shuang; clark, michele; hou, xiang-yu; zang, yuli; fitzgerald, gerard title: progress and challenges of disaster health management in china: a scoping review date: - - journal: glob health action doi: . /gha.v . sha: doc_id: cord_uid: ie xisg background: despite the importance of an effective health system response to various disasters, relevant research is still in its infancy, especially in middle- and low-income countries. objective: this paper provides an overview of the status of disaster health management in china, with its aim to promote the effectiveness of the health response for reducing disaster-related mortality and morbidity. design: a scoping review method was used to address the recent progress of and challenges to disaster health management in china. major health electronic databases were searched to identify english and chinese literature that were relevant to the research aims. results: the review found that since considerable progress has been achieved in the health disaster response system in china. however, there remain challenges that hinder effective health disaster responses, including low standards of disaster-resistant infrastructure safety, the lack of specific disaster plans, poor emergency coordination between hospitals, lack of portable diagnostic equipment and underdeveloped triage skills, surge capacity, and psychological interventions. additional challenges include the fragmentation of the emergency health service system, a lack of specific legislation for emergencies, disparities in the distribution of funding, and inadequate cost-effective considerations for disaster rescue. conclusions: one solution identified to address these challenges appears to be through corresponding policy strategies at multiple levels (e.g. community, hospital, and healthcare system level). d isaster health management is fast becoming a unique specialty around the world, with its governing theories and principles ( ) . essential phases of disaster management to improve the effectiveness of the disaster health response have made use of the 'pprr' continuum of prevention and mitigation (p), preparation and planning (p), response and relief (r), and recovery (r) ( , ) . the ultimate goal of disaster health management is to reduce the impact of disasters on human health and wellbeing by providing urgent health interventions and ongoing health care during and after disasters ( , ) . during a disaster, the healthcare system becomes a high profile element, critical to the immediate health response and recovery phase. the system itself can be impacted directly by the consequences of the disaster while at the same time being expected to have the capacity to respond to the sudden increase in the demand associated with the disasters ( , ) . the system, because it provides continuous health care, can be viewed as community infrastructure essential to the life-preserving front-line response ( ) . most of the extant research has occurred in high-income countries, such as the united states of america and has focused on the health system's disaster management (disaster health management), or the capability to supply medical services during disasters ( , , , ) . however, there is little available information from low-and middle-income countries ( ) . china, one such country, has been severely affected by multiple kinds of disasters including natural and manmade disasters and pandemics of infectious diseases ( , ) . to date, disaster management research into the health system in mainland china is in its infancy. while many studies in the chinese language have been published in national medical journals, they often lack scientific rigor (e.g. inappropriate study design, and the lack of empirical data). only a small number of investigators have published their studies in peer-reviewed international journals. moreover, few studies have evaluated the effectiveness of the current disaster arrangements. thus, there is an opportunity for researchers to share china's experience with international communities about the impact that disasters have on the health response systems. hence, it is essential to identify the full extent of the challenges that confront china in order to gain an understanding of those areas that require policy improvement and to assist in identifying strategies into the future. these challenges can also be used to benchmark with some high-income countries (e.g. the united states) to identify any gaps and priorities for improving disaster health management strategies. this paper aims to provide an overview of the status of disaster health management in china. it has several objectives: ) to identify the progress or current status of disaster management of the healthcare system in china; ) to identify current challenges; ) to discuss future strategies to overcome these challenges; and ) to identify future research directions. the 'pprr' disaster management continuum can be used to identify the progress and the challenges within each management phase. then corresponding strategies are proposed to promote the overall effectiveness of the health system response during and after major disasters and to reduce disaster-related mortality and morbidity by providing continuous healthcare. the aim of this review was to provide an overview of the extent of the challenges of disaster management rather than to undertake an in-depth assessment of individual studies. for this reason, we conducted a scoping review rather than a systematic review. the aim of the scoping review was to rapidly map the key concepts underpinning the research area using the main sources and types of evidence available ( ) . a scoping review can be used to address topics that are too broad for a systematic review, or have not been previously reviewed comprehensively ( ) . although we did not use meta-analysis (an approach commonly used for systematic reviews), systematic review methods were used where possible to minimize bias in the identification and inclusion of the studies ( ) . the 'pprr' continuum offered a preliminary framework which was used as a guide to identify the progress and challenges of disaster health management. the major health electronic databases including pro-quest, pubmed, ebsco, sciencedirect, web of science, and the chinese biomedical literature database were searched to identify publications such as public reports and peer-reviewed journal articles, which were relevant to the research aims. the search terms and their logical relation (e.g. and) were: 'disaster or emergency' and 'medical or health or hospital' and 'management or preparedness or response'. additional references were identified through an examination of the references from recent pertinent publications (snowballing) and through scrutiny of the contents pages of highly relevant journals for the previous years. the research inclusion criteria were: ) journal articles, governmental and institutional reports written in english or chinese in the past two decades; ) studies comprising relevant evaluations of the status or description of the progress and challenges of disaster management (i.e. disaster prevention, preparedness, responsiveness, and recovery) of the healthcare system in china; and ) other jurisdictions that had direct relevance to disaster health management in china (e.g. disaster healthcare management, disaster medical responses, emergency medical care, and emergency healthcare systems). the research exclusion criteria were: ) studies that only focused on disaster management of specific healthcare systems of other countries, without any implications to china; and ) studies with no detailed evaluations or descriptions that could assist in informing the identification or description of the progress and challenges of disaster health management in china. the article titles were scanned by two reviewers independently for relevance to the research aims; then the abstracts were appraised for relevance, significance, and utility. next, the full text format was retrieved for the remaining publications and analyzed in relation to their contributions to two areas: the identification of the main progress and challenges of disaster health management in china and the description of such progress and challenges. initially, a total of potentially eligible publications were retrieved. of these, were excluded through the screening of their titles and abstracts. after scanning the full text of the remaining publications, relevant publications were identified as potentially relevant to the current study; they included governmental and institutional reports and journal articles written in english or chinese. after an analysis of these publications, all were assessed as relevant to the study's aims, and thus were included in the review. over the past decade, china has witnessed a series of major disasters. as a consequence the ability of the health shuang zhong et al. system to respond to disasters has improved significantly. many of the resultant changes that have occurred stem from the lessons learned from these disasters and were implemented in an attempt to better respond to disasters in the future. first, in response to the sars crisis, the government acted to improve the prevention and management of infectious diseases. these initiatives included the establishment of a national infectious disease surveillance system and independent infectious disease hospitals; improved isolation facilities in emergency departments (ed); the upgrading of the isolation wards; improved training and monitoring of hospital staff in infection-control procedures; and improved compliance with the use of personal protection equipment ( Á ). a national integrated emergency response system has also been developed and promoted. china's national committee for disaster reduction (ncdr) was established in as the state inter-agency coordination body. it comprises ministries and departments, as well as military agencies and social groups ( ). the integrated system seeks to ensure the effective management of resources and rescue personnel from different facilities throughout china ( ) . in addition, there has been an integration of military medical resources into the disaster management system. the army hospitals have advantages that include: intrinsic infrastructure, well-trained staff, modern equipment, and communications and transportation systems ( , ) . in , china began establishing medical emergency teams across the country to respond to different disasters ( ) . many of these teams can be deployed from military hospitals. army hospitals are fully equipped with portable medical equipment and independent living supplies, so that they do not need to use local supplies ( , ) . they provide healthcare services by establishing temporary field hospitals, accepting and transferring patients, or providing expert rescue teams onsite ( , ) . despite this progress, there remain challenges that hinder efficient disaster health management in china. such challenges have been caused mainly because china is still in the early stages of health disaster management development ( ) . these challenges were identified and extracted from the literature and described in detail below. health infrastructure safety the world conference on disaster reduction endorsed a number of policies to ensure that 'all new hospitals are built with a level of resilience that strengthens their capacity to remain functional in disaster situations' ( , ) . disaster-resilient infrastructure is a primary guarantee for health care organizations to maintain their functions during disasters; they achieve this outcome through their ability to resist and absorb disaster impacts on physical facilities. resilient infrastructure includes not only physical strength but also back-up for the systems. however, no standard has been endorsed or enforced to ensure that healthcare facilities can resist natural disasters. in addition, back-up systems (e.g. electricity, water, and communication) were not fully considered when many hospitals were being built. for example the health facilities in the earthquake-prone areas of western and rural china rarely comply with the standards of construction, nor are their back-up systems required to resist natural disasters ( ) . the sichuan earthquake caused the collapse of . % of healthcare buildings in the worst affected areas ( ) . as a consequence, a large proportion of the county hospitals were destroyed or lost their critical systems. it is also noted that a number of the township hospitals and village clinics required temporary facilities to support their ongoing roles ( ) . thus, in china, the low standard of disaster-resilient infrastructure is the first challenge to efficient disaster response ( ) . an effective disaster response can be achieved only through sufficient preparedness before the occurrence of any disaster ( ) . however, several studies based on hospital evaluation surveys have revealed that china is still in the early stages of developing hospital emergency preparedness ( , , ) . in many provinces, hospitals were found not to have specific disaster plans for natural disasters that have a low frequency of occurrence (e.g. earthquakes and floods), novel infectious diseases, or terrorism attacks (particularly biological, nuclear, and radiation attacks) ( , , ) . moreover, the health facilities in many regions have a low level of essential preparedness in relation to disaster vulnerability analysis, disaster stockpiles, coordination with other institutions, emergency training in disaster first-aid, rescue, and the use of specialized supplies ( , , , ) . western and rural area hospitals are even less prepared, having lower proportions of these essential preparedness aspects ( , , ) . the availability of medical devices and equipment, especially the miniaturization and portability of medical devices, are crucial for the initial disaster medical response, as well as for onsite rescue ( ) . for instance, portable kidney doppler ultrasonography devices are effective for initial diagnoses and triage during mass casualty disasters ( ) . however, there are still inadequate portable medical devices in china. as happened during the wenchuan earthquake, an enormous amount of hospital equipment was unavailable in the hardest hit areas, with the larger equipment not being appropriate for onsite triage and treatment. further, during this event, most of the rescue teams were not prepared; they did not have portable radiography machines or ultrasonography facilities ( ) . such inadequacy may impede the ability of the rescue teams to provide first-line medical treatment during future natural disasters ( ) . emergency supplies are also an essential component of hospital disaster preparedness ( ) . while one study recently found that more than % of tertiary hospitals in the shandong province had stockpiles of emergency supplies (e.g. medicine, food, water, stretcher, and tourniquet), only a small number ( . %) of hospitals had signed a memorandum of understanding with other regional hospitals to share these supplies during disasters ( ) . disaster medical response capability a rapid and effective medical response by the local health services can be seen as the front-line of rescue efforts. this response is critical for facilitating the process of field triage, transport, and transfer ( ) . consideration of these factors assists the rational allocation of healthcare resources during disasters. currently, several crucial aspects for an effective health response are inadequate. the establishment of the triage criteria, based on the severity of the disaster and the availability of the health resources, is central to improving healthcare capacity during disasters ( , ) . a simple triage and rapid treatment (start) method was established after the wenchuan earthquake to facilitate site triage and injury classification ( ) . however, no standard triage procedure or guidelines have been fully adopted in china. instead, most hospitals have adopted disaster triage procedures from the general procedures used in ed ( , ) . the skills of the emergency staff in disaster management such as disaster triage skills were also found to be wanting, mainly due to the lack of targeted and appropriate disaster education and training programs. for example, the literature revealed that a large proportion of doctors had not received any formal training in triage, effectively relying on their own judgment which might cause bias, a delay in treatment or even waste scarce resources ( , ) . in addition, medical students also failed to receive appropriate disaster training. they acquire their training and skills in the inpatient wards of large tertiary care hospitals in urban areas where the emphasis is on making the right diagnosis rather than on the principles of triage and emergency management ( ) . to be effective, it is essential that hospitals surge their patient-care capacity in a short period of time after a disaster (e.g. within Á hours) ( Á ). however, chinese disaster surge capacity still lags behind other countries such as the united states ( ) . as revealed by previous research, most secondary and tertiary hospitals in beijing acknowledge they have insufficient surge (extra) beds to meet the demands during disasters, such as an infectious disease epidemic. the surge beds accounted for only . % of all the fixed beds after the sars crisis in ( ) . in , only . % of the tertiary hospitals in shandong province were able to surge patient-care beds, with the total surge capacity being . %, within hours ( ) . two reasons were identified for this low surge capacity. first, there was a lack of a hospital surging plan that used flexible surging strategies during disasters ( , , Á ) . for instance, in , only . % of the tertiary hospitals in the shandong province had surging plans; only . % of the hospitals adopted a variety of flexible procedures for surging their beds (e.g. through the early discharge of patients, the cancellation of elective admissions, or the transfer of patients). second, the health system was already under increased pressure from the growing daily demand ( , , ) . this human resource shortage compounded the limited surge capacity of the hospitals during disasters. as noted earlier, during the earthquake, the local healthcare workers were overwhelmed by the large number and the severity of casualties ( ) . when the acute phase of a disaster ends, the challenge moves to sustaining the long-term rehabilitation of the population, particularly those with disabilities and chronic diseases ( , ) . the psychological intervention guidelines for public emergencies were sued by the ministry of health. the guidelines stipulated two phases for psychological interventions. the first phase, the acute phase, occurs when general psychological counselling is used to reduce the incidence of posttraumatic stress disorder. the second phase, the chronic phase, occurs when psychological interventions are focused on issues associated with depression ( ) . however, to date, few programs exist for the evaluation and identification of psychological problems (especially during the chronic phase) of the population in the disaster areas. as a result, the targeted interventions remain inadequate for the treatment of large numbers of victims with psychological problems (e.g. postinjury stress disease), or for victims with the potential for psychological problems that arise during disasters ( ) . two factors underpin this inadequacy. first, psychological problems have become common especially during natural disasters and infectious disease outbreaks and these affect both the victims and the rescuers ( ). however, psychological problems have not received the same emphasis that physical illnesses and injuries receive. second, the local medical staff have not been welltrained in managing severe psychological effects, even in disaster prone areas ( , ) . further, there has been a nationwide shortage of senior experienced doctors and mental health professionals, which contributes to the lack of sensitivity to patients' psychological needs and impedes the supply of post disaster psychosocial interventions ( , ) . this workforce shortage became apparent during the wenchuan earthquake. in essence, there were insufficient professionals in the local area and they could not be dispatched at short notice to respond to the psychosocial problems ( ) . shuang zhong et al. several supporting systems were found to be wanting in terms of aiding the delivery of disaster relief emergency services, namely: the fragmentation of emergency health service systems, the lack of specific emergency legislation, the disparities in funding distribution, and inadequate cost-effective considerations. these systems are discussed below. fragmentation of emergency health service system. the prehospital emergency service is arguably the least developed aspect of the emergency medical service system. there are large variations in the structure of the pre-hospital emergency service across china ( ) . some large cities have independent pre-hospital emergency services, while others rely on hospitals ( ) . hence, the roles of hospital eds and emergency service centers overlap in some large cities such as beijing and shenyang ( ) . moreover, there is no official guideline, protocol, or legal standard for patient management and transfer between these two sectors. during disasters, the independence of these two sectors can lead to inefficiencies and the waste of valuable resources ( , ) . in most regions, pre-hospital emergency services lack effective cooperation with the fire and police departments. a lack of cooperation may result in the loss of precious rescue time for advanced pre-hospital medical care. lack of specific emergency legislation. in china, the legal foundation for disaster management has been established through the 'act on tackling emergency affairs ( )' ( , ) . however the document is not specific enough to be implemented in the local area. in addition, there are numerous legal obstacles that hinder appropriate disaster health management. first, there is a lack of a guaranteed reimbursement to the disaster healthcare services; this lack of reimbursement may encourage perverse financial disincentives. this situation may effectively discourage hospitals from becoming involved in disaster preparedness ( ) . without legal guarantees, few insurance companies will accept insurance for health staff working in the disaster areas ( ) . in addition, there is the need to have similar hospital command and control systems across hospitals in all responding sites, to ensure the maximum efficiency of mutual aid. however, to date, there is no such overarching command and control guideline to assist the different areas of china. this lack of legal clarification may impede the formulation of an integrated response system for disaster command, control and cooperation ( ) . also, the responsibility and authority of the different levels of government, the army facilities, and the non-governmental organizations are not clearly defined within the law. for non-profit organizations this vagueness may cause chaos during disasters ( ) . for example, the lushan earthquake highlighted the difficulties that can arise in the absence of a legal system to recruit and coordinate the volunteers. in that instance, the individual volunteers and unauthorized organizations entering the disaster area created road congestion and inadvertently, unnecessary casualties ( ) . further, without the legal enforcement to release details to the public about the use of donations, embezzlement of some of the donations for the wenchuan earthquake occurred. this event caused a credibility crisis for the public in regard to the donations given to the government-organized ngos (non-governmental organizations) ( ) . disparities in funding distribution. the funding gaps and the disparities in the distribution of funds present major challenges for healthcare organizations providing medical care during a disaster response ( ) . the first disparity occurs between the funding of urban and rural areas. for example, healthcare resources, modern healthcare facilities, and physicians are concentrated mainly in the urban areas while the rural areas are less well resourced ( , ) . there is also a tension between the allocation of resources for the immediate day-to-day needs and for disaster preparedness. in addition, investments that are put toward the improvement of emergency preparedness may compromise other more urgent programs such as primary healthcare in rural and western areas ( ). in addition, most funding was used for the reimbursement of actual expenses after a disaster. the government finance report indicates that most government funding was used for the wenchuan earthquake rescue (the central government invested . billion rmb, about us$ . billion), while the earthquake relief and preparedness funding amounted to . billion rmb (about us$ . billion). finally, since the health system reforms were introduced in the s, healthcare organizations have turned their attention to revenue-generating services ( ) . as a result, hospitals and professionals can be paid significantly more for their clinical services than their disaster-related work ( ) . thus, without sufficient financial allocations the motivation of hospitals to improve their disaster preparedness is likely to remain low. inadequate cost-effective considerations. the cost-effectiveness of disaster management is easily neglected especially during catastrophic disasters. when the disaster occurs the decisions about who and what to send to the disaster zone might be determined by dogma, rather than by scientific analysis ( ) . for instance, during natural disasters, a large number of search and rescue teams are dispatched to the disaster zones and part of the purpose of their role is moral inspiration ( ) . however, if there is an oversupply of search and rescue teams, the influx of too many teams may become a burden on the limited supplies for the victims, such as food, shelter, sanitation, and healthcare services ( ) . occasionally, outside aid agencies have been known to rush manpower, equipment, and supplies to a disaster area regardless of the local requirements, and without coordination with the other local organizations' plans and resources; this situation may lead to the waste of resources and result in low efficiency ( , ) . for instance, during a disaster, supplies are delivered from the outside (such as clothes and foods); these donations can be useless as they are inappropriate for the current situation. moreover, receiving these donations may cause a waste of valuable warehouse space and manpower. also, because the source is unknown, the donated items may need to be sterilized properly, which uses even more resources ( ) . several contributions have been made by this review to the broader body of knowledge. first, the review identified comprehensively the progress and challenges of disaster health management in china; this outcome was achieved through the extraction of relevant information from the literature, in both the english and chinese languages. indeed, the topic was found to be poorly covered. importantly, the review offered the opportunity to assess and evaluate the current status of disaster health management. it also provided a foundation for further in-depth analysis of the individual challenges and the progress achieved. second, some challenges involved the internal aspects of the health system while others arose from the external environment. the 'pprr' disaster management continuum integrates the internal challenges; it also offers a preliminary framework which can be used to highlight the progress and the weaknesses of each management phase. further, this continuum can be used to develop a proposed multi-strategic approach to address corresponding challenges with a view to enhancing disaster management in the future. most of the information that informed this scoping review of disaster health management in china was in the format of qualitative descriptions and analyses. because the topic has been poorly researched, few quantitative studies with empirical data were available for appraisal. further, these quantitative studies had limitations including the short length of the study period and the examination of samples of hospitals in a small number of locations or regions, for example, beijing, sichuan, and shandong. because of the limited amount of research in the literature, and in particular empirical research, the current study used scoping review methods to locate research materials that could then be used for a systematic review. despite the aforementioned limitations, the methods were appropriate for a policy analysis topic such as the current study which sought to identify the current status of and challenges to health disaster management in china. the limitations identified in the literature in terms of need for more rigorous research designs and information on health services in more areas of china provide considerable potential for future research. the current study revealed that the healthcare facilities' preparedness for disasters was under challenge by the vulnerability of the physical infrastructure, inadequate disaster plans, and disaster resourcing, and funding considerations. to enhance local disaster preparedness, multiple strategies need to be adopted. first, the local prioritized hazards need to be evaluated, while strict structural standards need to be enforced; these aspects are essential for reducing casualties from disasters ( , ) . for example, in the hardest hit area of the lushan earthquake, . % of the public buildings built after the wenchuan earthquake were still functional and able to be used. as a result, the new structural standards reduced the impact of the disaster on human health and wellbeing ( ) . second, operational disaster plans for healthcare facilities need to be devised, in advance. in addition, they need to take into consideration the communities' resources, hazards and other unique factors ( , ) . third, healthcare organizations need to have the capacity to be self-sufficient for the first to hours; this disaster coping capacity is essential as it may take this long for supplies to be delivered from the outside ( ) . fourth, non-governmental mutual assistance, as well as a social insurance mechanism, needs to be strengthened to decrease the gap between the governmental funding and the actual costs of the disaster relevant work ( , ) . finally, funds need to be allocated to local primary healthcare centers and hospitals to assist their roles in providing adequate capability as the first disaster responders ( ) . the scoping review revealed that research on surge capacity exists in developed countries, such as the united states; however, its concept and strategies are not fully adopted in the chinese context. nevertheless, some international surge strategies would appear to have the potential to be adapted into the chinese disaster-planning environment. these surge strategies would include: providing staff with onsite accommodation, and the training of non-clinical staff to support the fully trained staff ( , ) , cancelling elective surgery in order to focus on critical care ( ) , triaging the resources, and providing patients with adjusted standards of healthcare during the period of the disaster ( , ). other strategies would include converting non-clinical areas for surging clinical space (prepared in advance, with available power, water, oxygen, equipment and telecommunication) ( , , ) ; early discharge of stable inpatients or referring them to ancillary healthcare services (e.g. nursing homes and primary healthcare centers) ( , , ) ; and obtaining cooperative agreements with other facilities and off-site hospitals ( , ) . such considerations have the potential to assist the country to surge its capacity during times of disaster. in china, psychological interventions, triage skills, and other disaster management skills are limited by inadequate education in disaster management. thus, appropriate education or training curricula need to be developed and implemented to address these issues in the long term ( ) . such courses need to be available for hospital professionals as part of their ongoing professional development. systematic and ongoing training of staff in disaster skills and equipment usage should be conducted in highrisk communities. for example, staff should be trained in how to triage a large number of patients and with limited resources. the training programs used in other countries could be implemented but with appropriate modification to fit the chinese environment, as necessary. the american medical association has developed two courses that have this potential, but which are largely directed to the initial triage and management in the field and in the ed, namely the basic disaster life support course, and the advanced disaster life support course ( ) . currently, the fragmentation or lack of coordination of the emergency systems in china hinders efficient disaster management. the close coordination of the medical rescue services (e.g. government and non-government, domestic and international) is essential to overcoming this challenge ( ) . such cooperative channels should include strengthening effective cooperation from pre-hospital centers, hospital ed, and fire and police departments ( ) ; establishing a unified command and information platform for governmental agencies, national delegations, and ngos ( , ) ; and, finally, strengthening ngos, particularly with respect to their management of volunteers. a system similar to the us national verification system that would enable or facilitate the quick identification, recruitment and coordination of the medical volunteers is worthy of consideration ( ). based on this review, a number of research questions have been proposed with the aim of providing scientific evidence as the basis for disaster health management in china and facilitating policy-making that would overcome future challenges. these questions are listed below: q : how can the new concept of 'disaster preparedness' and 'surge capacity' be best implemented to prepare the local health system as the first disaster responder and integrate the health system into the local planning network? q : can user-friendly and validated tools be developed to evaluate hospital capability to cope with disasters? in order to evaluate the hospitals' actual ability to cope with disasters, the relevant validated evaluation tools will need to be tested during disaster simulations to identify the beneficial factors. hence, the tools can be used to monitor and analyze hospital response performance through the disaster drills. q : how can the research-to-policy interface be bridged? for example, can context-specific domestic disaster guidelines or plans be formulated to encourage vulnerable healthcare organizations to take adequate actions before or during disasters? can a minimum number of items be identified that should be stored in ed and which take into account specific regional and geographic needs and resources. q : how can evidence-based research be used to determine and specify whether the levels of ability are linked to a desirable outcome, and is the outcome regarded as adequate? for example, in terms of surge capacity, the thresholds for the extent of, and rapidity for, surge capacity should be investigated with considerations being given to different regional conditions. effective disaster management of the health system is essential for disaster response. this paper has identified the progress of and challenges to the chinese health system in providing continuous health care services during disasters. these challenges emanate from both the internal components of the health organizations and the external environment, which can directly or indirectly impede effective disaster health management. solutions that were identified to address these challenges require corresponding policy strategies at community, hospital and healthcare system levels. disaster 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streichert, laura title: steps to a sustainable public health surveillance enterprise a commentary from the international society for disease surveillance date: - - journal: online j public health inform doi: . /ojphi.v i . sha: doc_id: cord_uid: uj sph more than a decade into the (st) century, the ability to effectively monitor community health status, as well as forecast, detect, and respond to disease outbreaks and other events of public health significance, remains a major challenge. as an issue that affects population health, economic stability, and global security, the public health surveillance enterprise warrants the attention of decision makers at all levels. public health practitioners responsible for surveillance functions are best positioned to identify the key elements needed for creating and maintaining effective and sustainable surveillance systems. this paper presents the recommendations of the sustainable surveillance workgroup convened by the international society for disease surveillance (isds) to identify strategies for building, strengthening, and maintaining surveillance systems that are equipped to provide data continuity and to handle both established and new data sources and public health surveillance practices. online journal of public health informatics * issn - * http://ojphi.org * vol. in , the institute of medicine (iom) reported that the public health system in the united states had a multitude of deficiencies that impact the ability to effectively conduct public health surveillance. these included outdated and vulnerable technologies; a public health workforce lacking training and reinforcements; lack of real-time surveillance and epidemiological systems; and ineffective and fragmented communications networks. while considerable headway has been made since the iom report was published, there is still evidence of a need for further improvements. a recent report by trust for america's health, for example, found that there are persistent gaps in the ability of state and local public health agencies to respond to events ranging from bioterrorist threats to natural disasters and disease outbreaks. the question is-how can we reduce these gaps? nationwide and globally, rapid changes in health information systems, cloud computing technologies, communications, and global connections are catalyzing a re-examination of disease surveillance as an enterprise that needs coordinated and integrated system elements. sustainable surveillance, which we define as ongoing data collection, analysis, and application, coupled with a capability to respond to novel demands, is needed to ensure that public health agencies can perform reliably regardless of shifts in public health funding and priorities. the isds sustainable surveillance workgroup identified the following steps to maintain and advance the public health surveillance enterprise: . recognize systematic and ongoing public health surveillance as a core public health function that is essential for population health, economic stability, and national security. . create and support funding mechanisms that reinforce enterprise (i.e., integrated systems), rather than categorical (i.e., disease or program specific) surveillance infrastructures and activities in order to reduce inefficient silos, leverage resources, and foster synergies. . oppose further cuts to spending for surveillance activities. . invest in surveillance workforce development to build competencies and improve organizational capacity to utilize technological advances in surveillance practice. . advance a rigorous surveillance research and evaluation agenda that will deepen the understanding of community health, identify best practices, and provide evidence for decision-making. public health surveillance is defined as, "the systematic and ongoing collection, management, analysis, interpretation, and dissemination of information for the purpose of informing the actions of public health decision makers." in addition to providing information about the health status of our communities, surveillance is a foundation of emergency preparedness, food safety, infectious disease outbreak prevention and control, chronic disease assessments, and other key areas that protect the health, economy, and security of the public. while public health surveillance policy and practice have been indicated as priorities for policymakers at the national and global levels, [ ] [ ] [ ] [ ] questions remain about how to move forward from planning to implementation, especially in a time of critical cuts to federal funding. progress in health information technology (it) and the increased use of electronic data and new data streams offer great potential for innovation in surveillance science and practice. for instance, the self-reporting of health information through social media (e.g., twitter), as well as crowdsourcing projects such as flu near you (www.flunearyou.org) offer new options for collecting timely data. in addition, the health information technology for economic and clinical health (hitech) act, legislated as part of the american recovery and reinvestment act (arra) of , is fueling the adoption of electronic health record (ehr) systems in the u.s. in return for financial subsidies to implement ehr systems, hospitals and doctors are required to share data for public health purposes with the intent to improve both population health outcomes and the quality of clinical practice. sustainable surveillance systems have the potential to advance both of these goals. the value of public health surveillance . recognize systematic and ongoing public health surveillance as a core public health function that is essential for population health, economic stability, and national security. public health surveillance data is the foundation of public health programs and is required for a number of purposes, including: to demonstrate the size and impact of the public health problem being addressed by a program; to identify the population groups to which additional prevention efforts should be directed; to determine whether the problem is growing in size or abating; to provide feedback to data providers; and as part of an overall program evaluation strategy. the significant health impacts and economic costs of disease outbreaks illustrate the critical importance of effective public health surveillance and rapid response, as well as the cost of inaction. table provides examples of the health and financial burdens posed by some naturally occurring and intentional infectious disease outbreaks. the values reported in table do not fully reflect additional indirect costs of diseases and their potentially crippling effects on a community, nor do they address costs that are underreported/ unreported due to lack of data. higher rates of illness, for example, can lead to lower worker productivity, while premature mortality can reduce the size of the labor force, both of which have economic ramifications. there is growing evidence that these economic and societal costs can be mitigated by surveillance systems that are stable; a stable system provides the best foundation for identifying whether the problem being addressed is getting bigger or smaller or disproportionately affecting a section of the population, etc., while still allowing flexibility to provide useful information quickly about emerging issues. the optimum mix of stability and flexibility will depend on the purpose(s) of surveillance and the particular health condition under surveillance. for example, in ojphi the case of sars, an effective surveillance system has the potential to decrease the size of an epidemic by one-third and the duration by weeks, with significant cost savings. another study found that the early detection of an outbreak of highly infectious bacterial meningitis saved approximately $ for every dollar invested in infectious disease surveillance. yet another evaluation of surveillance practice found that technological improvements in a sentinel influenza-like illness (ili) surveillance system in virginia saved over $ , ( , hours) in staff-time during the - influenza seasons. ongoing surveillance can also inform the design and evaluation of prevention and intervention programs in order to control the escalating costs associated with chronic diseases in the u.s. and abroad. some experts forecast that chronic disease prevention programs could save up to $ . billion per year by , while others predict applying electronic medical record implementation and networking to the prevention and management of chronic disease will exceed the currently projected $ billion in annual savings. siloed surveillance systems are outdated, inefficient, and incapable of meeting today's demands for electronic data exchange and for the informatics capabilities needed to use the information for maximum benefit. integrated programs and collaboration, on the other hand, facilitate the efficient management of the complex, varied, and proliferating issues and information sources that exist today. the nature of public health surveillance also lends itself to multiple-purpose approaches in that strategies for preventing and controlling diseases, such as west nile virus, are to a great extent the same as for an influenza epidemic, a foodborne disease outbreak, or a bioterrorist attack. technology that enhances communication and data sharing across disease programs, surveillance systems, and even across jurisdictions increases the ease of obtaining and disseminating useful information to a broad audience, including public health agencies, healthcare providers, policymakers, and the general public. , this rapid information exchange not only facilitates timely response, but can also reduce emergency room visits, hospital admissions, and even costs of care. however, many health departments currently have systems that are not flexible enough to respond to changing health it needs, which makes it difficult to deliver information when and where it is needed. disease or program-specific funding also exacerbates program vulnerability to funding and budgetary cuts. for example, when funding is earmarked for specific purposes (e.g., emergency preparedness and associated surveillance systems), and then is reduced, such as has occurred for public health emergency preparedness cooperative agreement funding through cdc in the past seven years, it can undermine and reverse efforts to establish sustainable systems that serve multiple crosscutting purposes throughout public health. by contrast, an enterprise approach provides a cohesive framework that will better equip public health practitioners to address the challenges of processing large volumes of electronic data, and the concomitant analytical and visualization requirements. specifically, enterprise funding supports a reliable, flexible infrastructure that can adapt to technological and information requirement changes, and allows for ongoing data collection and the integration of new data sources to advance all-hazard preparedness. a white house memo acknowledged how programmatic funding can lead to inefficiencies and redundancies in system acquisitions and usage and called for applying technological and human resources across programs. by encouraging collaboration within and between departments, surveillance professionals can take advantage of shared platforms and resources to optimize data collection, analysis, storage, and dissemination, thus helping to reduce operational costs and improve efficiency. for example, collaboration could create opportunities for the effective integration of syndromic and reportable disease data for public health use. a lack of consistent and sustainable funding is hampering the necessary expansion and improvement of public health surveillance systems at local, state, and national public health agencies. a survey of local health departments conducted by the national association of city and county health officials (naccho) found that % of local health departments reported insufficient funding as one of their major barriers to modernizing their it systems. health data collection systems that take advantage of recent technological advances have proven to be more cost effective and sustainable in the long-term. stable funding is essential to supporting the adoption of hardware and software systems as they become available, leading to a robust and sustainable public health surveillance infrastructure able to integrate, manage, and communicate the plethora of data necessary to generate actionable results. the new age of disease surveillance requires a skilled public health workforce able to manage large volumes of increasingly complex electronic information, to understand the data flows, and to extract meaning from them. this calls for sophisticated and integrated competencies in public health informatics, epidemiology, statistics, and other areas, and the ability to present findings, draw conclusions, and make recommendations based on surveillance data. furthermore, in addition to needing people who can effectively operate existing surveillance systems and carry out tasks (such as the onboarding process for collecting newly available ehr data) there is also demand for people who can identify and assess new opportunities for surveillance and design new systems that take advantage of these opportunities. online journal of public health informatics * issn - * http://ojphi.org * vol. , no. , attracting and retaining experts in these fields is especially challenging in light of the comparatively low base salaries allotted to public health workers compared to the salaries of technology-intensive positions in other sectors. to align the surveillance workforce with new demands, the isds sustainable surveillance workgroup suggests the following approaches: • provide training programs for existing and prospective public health workers to equip themselves with the necessary expertise and skills to work in rapidly evolving it systems. • promote public health careers at the primary, secondary, undergraduate, and graduate levels across disciplines. • provide competitive salaries to recruit and retain a workforce skilled in public health surveillance and informatics. . advance a rigorous research and evaluation agenda that will deepen the understanding of community health, identify best practices, and provide evidence to inform decision-making. research and evaluation play an important role in connecting the processes of information collection, information use for decision-making, and translation of decisions to actions and measurable outcomes. research-based evidence and evaluation results can help to identify the limitations and benefits of different surveillance procedures for better decision-making and more effective resource allocation. investing in research and applying the rigors of science to public health surveillance questions leads to informed decisions on how best to direct efforts and resources. in addition, periodic evaluations of surveillance infrastructuresthe systems and people-are needed to assess return on investment and opportunities for quality improvement. effective and efficient surveillance systems are proven to save money and lives. the ability to detect and respond to known and emerging pathogens is central to protecting and maintaining population health. the breakdown or absence of a stable public health surveillance infrastructure, on the other hand, can undermine efforts to mitigate disease outbreaks and other public health events. public health surveillance systems built on a strong infrastructure of core workforce competencies, information systems, and organizational capacity, and supported by consistent and enterprise-based funding, are essential if we are to understand and respond to the real and growing threats to population health. by providing political commitment and financial support to this issue, decision makers can play an active role in advancing the health of individuals, communities, and nations. the future of the public's health in the st century ready or not? -protecting the public's health from diseases, disasters, and bioterrorism international epidemiological association. a dictionary of epidemiology the white house public health surveillance and informatics program office blueprint version . ": updating public health surveillance for the st century sixty-fifth world health assembly: world health organization act enforcement interim final rule hitech. u.s. department of health and human services public health surveillance and meaningful use regulations: a crisis of opportunity improved diagnostic accuracy of group a streptococcal pharyngitis with use of real-time biosurveillance measuring and valuing productivity loss due to poor health: a critical review summary of probable sars cases with onset of illness from estimating the global economic costs of sars learning from sars: preparing for the next disease outbreak: workshop summary investigation of bioterrorism-related anthrax total decontamination cost of the anthrax letter attacks epidemiology: infectious diseases: preparing for the future avian influenza: economic and social impacts officials warn of pertussis outbreak. abc news local health department costs associated with response to a school-based pertussis outbreak california west nile virus website economic cost analysis of west nile virus outbreak health department releases costs of salmonella probe. bismarck tribune global epidemics and impact of cholera. world health organization geneva: world health organization different epidemic curves for severe acute respiratory syndrome reveal similar impacts of control measures analysis of the value of local public health operations spending. public health -muskegon county cost-effectiveness of influenza-like illness sentinel surveillance in virginia. virginia department of health world bank return on investments in public health: saving lives and can electronic medical record systems transform health care? potential health benefits, savings, and costs strengthening the nation's public health infrastructure: historic challenge, unprecedented opportunity mission creep: public health surveillance and medical privacy fast access to records helps fight epidemics. the new york times state-by-state update report on preparedness and response white house office of management and budget. omb circular a- revised. the white house integration of syndromic surveillance data into public health practice at state and local levels in north carolina the status of local health department informatics. results from the naccho informatics needs assessment. national association of city and county health officers replacing paper data collection forms with electronic data entry in the field: findings from a study of community-acquired bloodstream infections in pemba, zanzibar design and operation of state and local infectious disease surveillance systems the public health enterprise: examining our twenty-first-century policy challenges the public health infrastructure and our nation's health public health's infrastructure, a status report to the u.s. senate appropriations committee key: cord- -q o nxs authors: ruscio, bruce a.; brubaker, michael; glasser, joshua; hueston, will; hennessy, thomas w. title: one health – a strategy for resilience in a changing arctic date: - - journal: int j circumpolar health doi: . /ijch.v . sha: doc_id: cord_uid: q o nxs the circumpolar north is uniquely vulnerable to the health impacts of climate change. while international arctic collaboration on health has enhanced partnerships and advanced the health of inhabitants, significant challenges lie ahead. one health is an approach that considers the connections between the environment, plant, animal and human health. understanding this is increasingly critical in assessing the impact of global climate change on the health of arctic inhabitants. the effects of climate change are complex and difficult to predict with certainty. health risks include changes in the distribution of infectious disease, expansion of zoonotic diseases and vectors, changing migration patterns, impacts on food security and changes in water availability and quality, among others. a regional network of diverse stakeholder and transdisciplinary specialists from circumpolar nations and indigenous groups can advance the understanding of complex climate-driven health risks and provide community-based strategies for early identification, prevention and adaption of health risks in human, animals and environment. we propose a regional one health approach for assessing interactions at the arctic human–animal–environment interface to enhance the understanding of, and response to, the complexities of climate change on the health of the arctic inhabitants. w hile circumpolar collaboration on health and the environment has never been greater, the magnitude and complexity of the health challenges facing the arctic are daunting. looking forward, a comprehensive approach to health will catalyse actions that protect the health of the region's people, animals and environment. this can be achieved with a regional one health approach among the nations and permanent participants of the circumpolar north. understanding the health risks of climate change in the arctic will require scientists, policy makers, communities and public health experts to collaborate beyond the confines of their disciplines and borders, and one health provides an approach to detect the emergence of climate-sensitive health threats in the region. as a shared regional approach, one health can enhance disease prevention and resiliency for arctic inhabitants. while biologists, climatologists, geographers and oceanographers define the arctic differently, for the purpose of this article, the circumpolar region consists of regions wholly or partly located above n and includes approximately million square kilometres. the countries of this region include canada, the kingdom of denmark (specifically, greenland and the faroe islands), finland, iceland, norway, russia, sweden and the united states. the region is home to diverse environments and populations of plants, animals and people living in some of the most extreme conditions on the planet. the physical and biological environments are diverse and include temperate rainforest, boreal forest, tundra, polar desert and cold oceans. there are approximately million human inhabitants in the region that are ethnically diverse with dozens of indigenous groups ( ) . many of these people still have traditional subsistence economies based upon gathering wild plants, hunting fishing and herding of reindeer ( , ) . the region is known as being both rugged and resilient, due in part to the persistent cold temperatures and the largely frozen condition of the land and sea. however, as the arctic warms and the lands and ice thaw, the region is increasingly fragile. arctic temperatures have risen at twice the rate of other parts of the world resulting in decreased sea ice, coastal erosion, changes in precipitation magnitude and frequency, permafrost thawing and altered distribution of plant and animal species ( ) . the associated health risks for humans and animals include potential changes in pathogen and vector demographics affecting disease patterns; degradation of drinking water quality and availability, food quality and availability, and changes in animal and plant species health, among others ( Á ). rapid change and recognition of the emerging health threats have resulted in a concerted effort to enhance regional and international partnerships to share best practices in disease surveillance and prevention strategies ( , ) . understanding the evolving health threats and anticipating and managing risks influenced by the dynamic impacts of climate change in the arctic will require innovative science, novel tools and even greater integration of efforts. the implications of health risks Á to arctic populations and those beyond Á calls for broad and diverse stakeholder collaborations to advance the fundamental understanding of emerging health threats, and the development of shared initiatives that decrease vulnerabilities of human and animal communities and the environment. an integrated and holistic approach will be essential for providing the evidence of links between climate change and health risks to support sound policy development. one health represents an approach for developing and sustaining broad transdisciplinary collaboration for the early identification, prevention and mitigation of health risks in human, animals and the environment. while there are slightly varying definitions of one health, most are similar to this european union definition: one health is an integrated approach to health that focuses on the interactions between animals, humans and their diverse environments. it encourages collaborations, synergies and cross-fertilization of all professional sectors and actors in general whose activities may have an impact on health. ( ) one health recognizes that understanding these interactions and interdependencies necessitate an integrated perspective ( , ) . one health is not new, though it has gained significant attention over the past decade. an integrated approach to animal, human and environmental health issues can be traced to ancient times. the concept of one health in the modern age evolved from the theory of one medicine developed by sir william osler in the late s and further elaborated by calvin schwabe in the s ( , ) . recent attention to one health can, in part, be attributed to acknowledgement of complex health-related issues associated with rapidly growing populations, increasing speed and magnitude of human travel and migrations, environmental degradation, and disturbance, societal instability and climate change. visible effects of these forces are expansion, range shift and new emergence of animal, plant and human diseases ( , ) . the vast majority of emerging disease outbreaks over the past years have been due to zoonotic or vector-borne disease. these health risks are evident in the emergence, re-emergence and/or global spread over the past decade of a wide range of infectious diseases: hanta virus, ebola, h n influenza (which reached pandemic levels in ), highly pathogenic avian influenza (h n ), west nile virus, rift valley fever virus, norovirus, dengue and chikungunya viruses, severe acute respiratory syndrome, marburg, e. coli o :h , yersinia pestis (plague) and bacillus anthracis (anthrax) ( ) . while animal health, human health and environmental health are intricately linked, our approach to understand these health risks are mostly independent. the needed collaboration and communication across and between scientific disciplines has been lacking or non-existent. one health advances a sustained partnership across disciplines and has demonstrated accomplishments in understanding complex health risks (see www.onehealthinitiative.com/ and www.cdc.gov/ onehealth/in-action/index.html). further, by focusing on the interface of humans, animal and the environment, one health can help predict outbreaks of disease through a more in-depth understanding of the development and transmission of diseases. there is a need to advance the fundamental understanding of climate change impacts on arctic health and provide the quantitative evidence base for enhanced decisionmaking that will lead to scientifically sound and societally supported public policies. one health is a particularly well-suited approach to advance the understanding of the constantly changing health threats resulting from the direct and indirect impacts of climate change in the arctic. specifically, an arctic one health approach can enhance surveillance capacity to monitor climate-sensitive health risks; advance a regional baseline understanding of the interaction between human and animal disease and disease vectors and increase the understanding of the relationship between climate changes and emerging of health risks and benefits. the circumpolar north provides an optimal venue for a regional one health approach. first, the components of a one health approach are already evident ( ) . there is a strong history of local, national, regional and international cooperation among diverse stakeholders in addressing human, animal and environmental health issues ( , ) . second, one health can enhance the exchange of information and take into account local and traditional knowledge and participatory communitybased approaches in identifying and responding to health issues. at the core of a one health approach are those stakeholders in close proximity to the natural environment and include local communities and indigenous peoples. third, there are on-going programs, systems and networks working in close collaboration that include local and regional government, multidisciplinary science communities, research institutes, academia, non-governmental agencies, the private sector, civil societies, native organizations and other stakeholders ( , ) . one example of a transdisciplinary organization is the alaska one health group. the one health group was formed in and is hosted by the alaska native tribal health consortium and the u.s. centers for disease control, arctic investigations program. the group participants include professionals in the fields of plant, wildlife and environmental health and management, and public health, among others with representative from canada, alaska, and other parts of the united states. they meet quarterly to discuss emerging one health issues, to consider events that are indicative of environmental and climate change and to provide a forum for identifying areas of common interest and collaboration (see www.anthc.org/chs/ces/ climate/aohg.cfm). the group maintains a current web accessible one health map, which provides a visual aide to help track emerging and trending events. the maps include events screened from news reports, selected posts from the local environmental observer (leo) network and additions made by group members. updates on trending events are also provided and presentations by topic experts. trending topics have included important food security events such as increases in toxicity and frequency of harmful algal blooms and die-offs of fish, sea mammals and birds. fourth, arctic stakeholders are experienced at integrating collaborative scientific and health policy development across disciplines, cultures and borders ( ) . networks are in place that coordinate different aspects of arctic health including environmental monitoring, animal and human disease surveillance and reporting ( ) . fifth, there is recognition of the need for an operational, multidisciplinary and holistic model for assessing and responding to all health risks ( ) . finally, there is a track record of policy makers receptive to and influenced by knowledge from diverse scientific and traditional disciplines. for example, scientific data and indigenous traditional knowledge have resulted in evidence-based policy development in the united states, canada and nordic countries on research agendas, interpreting data and local community policy formulation ( ) . it is also important to highlight the efforts that have enhanced international partnerships for sharing best practices in disease surveillance and prevention strategies on health risks across the circumpolar countries ( ) . international collaborations on policies, programmes and initiatives in the arctic have supported the integration of stakeholders and disciplines since human health became a specific focus for research in with the establishment of the nordic council committee for arctic medical research ( , ) (see table i ). two working groups under the artic council focussing on human health include the arctic monitoring and assessment program and the sustainable development working group formed in and , respectively ( ) . in , the arctic council established the arctic human health expert group (ahheg) to more fully integrate the assessment of human health risks with environmental issues ( ) . the charter of the ahheg is to advance collaboration between all stakeholders on integrated efforts to attendant human health issues with knowledge gained through environmental and community-based research. in , the health ministries of the arctic states issued the nuuk declaration, which describes the prioritized areas of concern and actions on health issues and specifically identifies circumpolar cooperation on assessing climate change impacts on health ( ) . also in , the arctic council established the international circumpolar surveillance climate change and infectious disease group to strengthen the integration of animal and human health systems to minimize disease emergence in the arctic ( , , ) . harmonizing existing efforts and creating a sustained regional one health approach will entail an implementation strategy, supporting policies, a critical mass of engaged stakeholders at both grassroots and leadership levels, and sustained commitment in the form of funding and time. paradigm shifts are not easy. assessments of the adoption of the one health approach have concluded that while the concept and principles have been broadly accepted and endorsed, operationalizing has been more challenging ( , ) . these challenges include poorly defined unifying one health efforts, a lack of one health champions and partners, limited resource and policy hurdles, among others. however, calls for guidance on how to move beyond concept has resulted in recommendations and roadmaps outlining steps, programme metrics and programme assessments to operationalize one health ( , ) . an implementing strategy for arctic one health approach will benefit from using one of the recently developed one health operationalizing ''road maps.'' two examples include the work done by the university of minnesota and us department of agriculture (usda), and andrea meisser and anne levy goldblum ( , ) . developing a strategy with process steps, progress measures and well-defined milestones will be crucial in obtaining broad-based support for a regional one health effort. the implementation strategy process can, and should, assess vulnerabilities, evaluate alternative strategies and programmes for health risks identification and assessments, assess the costs and benefits of those various options and promote their adoption and/or adaptation. tools for moving this strategy forward are described below. the university of minnesota and the usda developed the one health systems mapping and analysis resource toolkit (oh-smart), an interactive mapping process and framework for a one health approach to infectious disease threats. the oh-smart has been successfully used to analyse connections between and among public health, animal health and wildlife sectors, and facilitate improvements in the context of one health operationalization ( ) . the tool provides an approach for developing system-based maps detailing agency and stakeholder interactions specific to one health challenges. the information and data promote stakeholder awareness to analyse processes and strengthen interactions. the oh-smart process would be applied to increase the awareness of arctic cross-disciplined partners and activities, to analyse current practices and to create a shared understanding of the current status of one health approaches. the resulting assessment and baseline information would be used to illuminate the way forward for a one health approach for the arctic region, see fig. . the second tool is an outcome of a meeting of one health experts in bellagio, italy, to assess the global progress of the adoption of the one health approach ( ) . this group of experts conducted a global inventory of on-going one health efforts and evaluated each programme against an assessment tool for achieving transformational change. while initially developed as an assessment instrument, the authors identified applicability as a change model tool for the transformation of one health approaches to operationalized programmes. five components of change were identified and characterized in this transformation roadmap: mobilize commitment, shared vision, organization and human resource alignment, operationalization and transformation. each component involves processes needed to successfully achieve programme transformation. the tool identifies both activities and policies requirements. further, as a guide with assessment criteria, the road map can be used to measure progress and help identify technical, agencies and policy hurdles and opportunities to achieve an operationalized one health end point. the transformation would not necessarily proceed in a linear manner and would build on existing programs and activities, incrementally advancing to a fully integrated regional one health approach (see table ii ). climate change impacts on the arctic region are rapid and dramatic. for arctic inhabitants, with deep cultural connection to the environment, the associated health risks to humans, animals and the environment are increasingly apparent in everyday life. currently, we lack a full understanding of these risks to humans, animals and the arctic environment. now it is the time for a new comprehensive perspective of climate change impacts on arctic health. one health is a transdisciplinary approach ideally suited for addressing health issues in complex systems such as the arctic. the one health approach promotes collaborative approaches to the collection, analysis and interpretation of a wide range of data to anticipate and respond to the rapidly changing environment and its health impacts on human and animal communities. a one health approach can provide critical lead time and early warning of impending dangers while stimulating more innovative collaborative intervention options for prevention and response. an integrated one health approach addressing the potential health effects at the humanÁanimalÁenvironment interface will enhance the resilience of arctic communities and the environment in the circumpolar region. greater scientific understanding of the threats can contribute new tools for effective policy to reduce the burden of health risks and support capacity-building and preparedness. these tools include methods for assessing vulnerability, health and disease screening strategies and programmes for characterizing climate risks, identifying adaptation options, and weighing the costs and benefits of different policies. consideration should be given to regional one health approach in the arctic. recently developed one health programme assessment instruments and change models can help the multiple affected stakeholders and communities catalyse transformational changes in behaviours, infrastructure and capacity. additionally, the tools can be used as metrics to assess progress, and to report success and hurdles to stakeholders, the community and policy makers. a regional one health approach, with multiple disciplines working together locally, nationally and internationally at the humanÁanimalÁenvironment interface collect and share experiences of arctic stakeholders,current situation across the region on one health initiatives/programs define/characterize local and regional processes and initiatives addressing arctic health challenges conduct an arctic-wide disease outbreak table top exercise to describe stakeholders, processes communication, collaboration and structure as a gap analysis process develop arctic specific innovative ideas, platforms,and opportunities to harmonize and strengthen regional systems will significantly contribute to effectively manage climate change and its impact on the health of the arctic. the health impacts of climate change in the arctic are real and expanding. while adopting a one health transdisciplinary approach represents a major paradigm shift, many short-term opportunities exist for quick wins despite limited resources. an incremental approach following the innovation maxim ''think big, start small, scale fast'' has the potential for significant sustained health benefits for the arctic into the future. ecohealth Á the health of ecosystems representing the complex interactions between people, social and economic conditions, culture and the natural environment. holistic approach Á a systems approach. a focus on, or concerned with, the complete system rather than with the analysis of, treatment of, or dissection into parts. resiliency Á the ability to absorb perturbations and disturbances before fundamental changes occur in the system ( ) . the ability to successfully adapt to adversity. transdisciplinary Á collaboration in which exchanging information, altering discipline-specific approaches, sharing resources and integrating disciplines achieves a common scientific goal ( ) . the findings 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force. one health: a new professional imperative the other branch of medicine: a historiography of veterinary medicine from a canadian perspective veterinary medicine and human health social and environmental risk factors in the emergence of infectious diseases one health and climate change: linking environmental and animal health to human health the global one health paradigm: challenges and opportunities for tackling infectious disease at the human, animal, and environment interface in low-resource settings climate change and infectious diseases in the arctic: establishment of a circumpolar working group the circumpolar health movement comes full circle, part i. historical relevance of the proceedings of the international congresses on circumpolar health identifying indigenous peoples for health research in a global context: a review of perspectives and challenges climate change health assessment: a novel approach for alaska native communities circumpolar health collaborations: a description of players and call for further dialogue working with northern communities to build collaborative research partnerships: perspectives from early career researchers arctic health policy: contribution of scientific data the nordic council for arctic medical research: history, aims and achievements circumpolar health research network improving human health in the arctic: the expanded role of the arctic council's sustainable development working group the arctic health declaration international circumpolar surveillance, an arctic network for surveillance of infectious diseases international circumpolar surveillance: prevention and control of infectious diseases: Á . oulu: circumpolar health suppl operationalizing the one health approach: the global governance challenges us center for disease control and prevention. operationalizing ''one health'': a policy perspective-taking stock and shaping an implementation roadmap assessing global adoption of one health approaches operationalizing one health for local governance. in: one health: the theory and practice of integrated health approaches making one health operational: strengthening interagency coordination through systems mapping and analysis biodiversity in the functioning of ecosystems: an ecological synthesis the potential of transdisciplinary research for sustaining and extending linkages between the health and social sciences the authors have not received any funding or benefits from industry or elsewhere to conduct this study.process steps for a regional arctic one health has the future state/vision been achieved?does is require modification?have the goals and objectives been achieved?-what impact has been achieved? -has the documented impact been shared broadly with health professionals, policy makers, politicians, partners and stakeholders?a strategy for health resilience in the arctic key: cord- -axv kys authors: van beveren, laura; rutten, kris; hensing, gunnel; spyridoula, ntani; schønning, viktor; axelsson, malin; bockting, claudi; buysse, ann; de neve, ine; desmet, mattias; dewaele, alexis; giovazolias, theodoros; hannon, dewi; kafetsios, konstantinos; meganck, reitske; Øverland, simon; triliva, sofia; vandamme, joke title: a critical perspective on mental health news in six european countries: how are “mental health/illness” and “mental health literacy” rhetorically constructed? date: - - journal: qual health res doi: . / sha: doc_id: cord_uid: axv kys in this study, we aim to contribute to the field of critical health communication research by examining how notions of mental health and illness are discursively constructed in newspapers and magazines in six european countries and how these constructions relate to specific understandings of mental health literacy. using the method of cluster-agon analysis, we identified four terminological clusters in our data, in which mental health/illness is conceptualized as “dangerous,” “a matter of lifestyle,” “a unique story and experience,” and “socially situated.” we furthermore found that we cannot unambiguously assume that biopsychiatric discourses or discourses aimed at empathy and understanding are either exclusively stigmatizing or exclusively empowering and normalizing. we consequently call for a critical conception of mental health literacy arguing that all mental health news socializes its audience in specific understandings of and attitudes toward mental health (knowledge) and that discourses on mental health/illness can work differently in varying contexts. media coverage on mental illness and its effect on public beliefs and attitudes toward mental health problems have long been and still are a topic of scholarly interest (cabrera et al., ; mcginty et al., ) . previous research has shown that mainstream media often negatively associate mental illness with danger, violence, and sensation, which might contribute to social and self-stigma and hinder people experiencing mental distress from seeking (professional) help (corrigan et al., (corrigan et al., , savage et al., ) . mental health literacy initiatives and awareness campaigns aimed at educating the public about mental illness, its causes, and available treatments options are considered valuable tools in the reduction of stigma and in the encouragement of more appropriate help-seeking behavior (jorm, ; kelly et al., ; wahlbeck, ) . central to many of these literacy projects is the "mental illness as a disease like any other" approach. this approach aims to replace beliefs, myths, and moralistic understandings of the nature, cause, and treatment of mental illnesses with bioneurological scientific facts, which are considered to improve public attitudes toward mental illness by reducing perceived individual responsibility and blame (gardner, ; read et al., ) . the emphasis on such medical literacy has been related to linear understandings of news media as means to transmit takenfor-granted scientific information to a lay audience (hallin & briggs, ; seale, ) . critical health communication researchers have critiqued this approach: rather than focusing on the scientific and medical accuracy of health news coverage, these scholars emphasize the constructed nature of health news and have indicated the need for more research that recognizes and studies the different ways in which media are actively involved in the social construction of what constitutes health and illness (dutta, ; lupton, ; zoller & kline, ) . in this study, we aim to contribute to the field of critical health communication research by examining how notions of mental health, mental illness, and mental health literacy are discursively constructed in the mental health reporting of newspapers and magazines in six european countries. in the following sections, we first align ourselves with critical-discursive theories of mental health/illness. next, we connect these perspectives to the field of critical health communication by drawing on briggs and hallin's ( ) recently developed framework of biocommunicability. this framework conceptualizes the different ways in which media constructions of (mental) health and (mental) illness operate in the governing of the healthy citizen as they implicitly communicate to the audience ideas on what constitutes legitimate (mental) health knowledge and who produces, circulates, and consumes it. following the arguments of briggs and hallin ( ) , this study is thus not concerned with demonstrating the value of mental health news in enhancing the scientific and medical literacy of the readers, but rather aims to study how all news stories communicate specific ideas on mental health/illness and on how different actors should engage with mental health (knowledge). scholars and advocates from various disciplinary fields have emphasized the epistemologically and ontologically ambiguous nature of mental illness and have contested the uncritical adoption of psychiatry, clinical practice, and their classifications of mental health and illness as scientific-objective, neutral, and acultural (bracken & thomas, ; kleinman, ; pickersgill, ) . drawing on conceptions of human (inter)subjectivity as embedded in social, historical, and cultural contexts, these authors instead disclose mental health/illness as a value-laden notion that is grounded in specific cultural constructions of the relationship between mind, body, and society (teo, ) . building on the works of foucault, rose ( rose ( , ) has studied the cultural impact of psychiatric discourse on our understandings of (mental) illness and health. he illustrates how neoliberal and biopsychiatric subjectivities currently intersect in discourses that center around the enterprising self, which have increasingly come to occupy domains of life such as leisure, education, and media. in this process of biomedicalization, the enterprising self appears as a rational subject that manages social risks, which now appear as the individual genomic risk (to develop a mental disorder) that everyone carries, by constant self-monitoring and by making well-informed health and lifestyle decisions (see also clarke et al., ; dumit, ) . the framework of biocommunicability, recently developed by briggs and hallin ( ) , is especially concerned with the performative and pedagogical power of health news in the production of cultural understandings of health, disease, biomedicine, and the healthy citizen more generally. the framework aims to elaborate on the concept of biomedicalization by relating it to the process of biomediatization, referring to media's "co-production of medical objects and subjects through complex entanglements between epistemologies, technologies, biologies, and political economies" (p. ). in line with criticalinterpretive perspectives on health communication (on this, see dutta, ; lupton, ; zoller & kline, ) , briggs and hallin ( ) consider public health and medicine on the hand, and communication and media on the other as impinging upon and co-producing one another, rather than as two separate spheres, with the role of the latter reduced to representing to an audience that needs to be informed about the preexisting medical objects and subjects of the former (seale, ) . indeed, the fact that psy-discourses are no longer confined to traditional professional and institutional psy-domains and have instead come to occupy mainstream and popular media channels (binkley, ; kirkman, ) requires an understanding of mental health news as actively negotiating cultural legitimacy for specific conceptions of mental health/illness (knowledge) (kurchina-tyson, ) . according to briggs and hallin ( ) , the performative or biopedagogical power of health news manifests itself in the two layers that can be distinguished in each health news story: in addition to providing the audience with cultural understandings of health and disease, they teach the public about what counts as valuable health knowledge, who produces it, how it circulates, and who receives it. health news is thus performative and pedagogical in the sense that it interpellates different actors to take different positions toward health knowledge and socializes the audience in specific ideas of what counts as biocommunicable success (accepting ascribed positions) or biocommunicable failure (failing to take up or challenging ascribed positions). although the framework of biocommunicability focuses on health and disease in general, kate holland ( , a , b has engaged with it to study how media and communication figure in the biopolitics of mental health/illness in particular. the framework of biocommunicability distinguishes three cultural, normative models of production, circulation, and reception of (mental) health knowledge, each of them "woven into the words and images of stories themselves" (briggs & hallin, , p. ) . the model of biomedical authority assumes media communication on health to follow a linear-hierarchical trajectory in which biomedical authorities produce health knowledge that is subsequently communicated to a not-yet-knowing and passive lay audience. distinctions between knowledge and nonknowledge about health are constructed in terms of good science (i.e., objective facts, technological progress) versus bad science (i.e., pseudo-science, myths, and beliefs) (briggs & hallin, ) . in this context, health news often appears as a form of health education given its commitment to enhance the public's medical and scientific literacy (hallin & briggs, ) . with regard to mental health, this model can be related to the "mental illness as an illness like any other" approach to mental health literacy (read et al., ) . the patient-consumer model, which according to briggs and hallin ( ) has overruled the dominance of the former model, assumes a more agentic role for the service user/patient and shifts biocommunicable power relations to introduce a concept of the public as consisting of rational and active information seeking individuals that are capable of making choices and managing their own health/treatment (briggs & hallin, ) . this resonates with rose's ( ) notion of the enterprising self, with (mental) health appearing as a commodity that should be actively and responsibly pursued by everyone. in this context, (mental) health journalism takes up the role of informing the public about all of the treatment choices available, often drawing on the genre of first person celebrity-accounts or stories about persons overcoming their (risk of developing) mental health problems (binkley, ; briggs & hallin, ; holland, ) . again, (mental) health news acts as a form of health education, with mental health literacy appearing as a matter of access to information to make the right health decisions, and as an asset that might actually "do much of the work" and reduce either the need for or the unnecessary use of (costly) public services (teghtsoonian, , p. ) . the public sphere model disrupts the traditional biocommunicable hierarchies evident in the two previous models by considering health, medicine, and science as value-laden, contingent, and contestable notions that can and should be debated publicly. service users/patients and the public at large are addressed as citizens who have both stakes in public health discussions and valuable contributions to make. by being an (implicit) ally to the public or taking up an activist stance themselves, journalists support a process of renegotiating what counts as legitimate or expert knowledge about health (briggs & hallin, ) . with specific regard to mental health/illness, much of the activist and theoretical work in this area has been done by advocates, researchers, and professionals involved in the critical disability and survivor movements, whose efforts have called attention to the complex interplay of the material, historical, cultural, and political constituents of mental health problems (goodley et al., ; lefrançois et al., ) . in an important note on the three models, briggs and hallin ( ) remark that the discursive workings of a health news story often cannot be confined to one particular model, but rather form biocommunicable cartographies in which different models combine and intersect in complex, sometimes contradictory ways. the complexity of mental health/illness news thus calls for an analysis that goes beyond binary classifications of media representations as either positive or negative. in the next section, we explain how we set up a qualitative study using rhetorical analysis as a methodological lens to examine the cultural understandings of mental health/illness and the biocommunicable cartographies produced and circulated in mental health news in six european countries. this study is part of the larger "mentally-together for better mental health care" research project. the project has received funding from the european parliament and aims to gather qualitative information on mental health professionals' and service users/patients' perspectives and the public mental health debate to gain a better understanding of notions of access and quality in european mental health services. in the project, researchers from six european countries, that is, cyprus, greece, belgium, the netherlands, sweden, and norway, collaborate to form an interdisciplinary research team that covers the disciplines of clinical and social psychology, public health studies, and discursive-rhetorical studies. the selection of the six countries was informed by their scores on the euro health consumer index which includes countries measured on indicators. the six countries reflect an adequate amount of european diversity considering patient rights and information, accessibility of health care, health outcomes, range and reach of services provided, prevention efforts, and use of pharmaceuticals. furthermore, the selection of three pairs of countries allows for a diversity in economic-political and cultural contexts (e.g., with the economic situation of greece and cyprus largely characterized by the consequences of the "crisis years" and severe austerity measures), yet also assures the inclusion of countries with comparable cultural contexts, but different mental health service systems (e.g., the norwegian system being much more centralized than the swedish system). the project was ethically approved by the ghent university ethical commission on march , (for more information, see http:// mentally-project.eu/). data were collected through a systematic key word search in mainstream media sources in all six european countries. more specifically, in each country, the two most read quality newspapers and popular newspapers were searched as well as the most read senior's, men's, women's, lifestyle, sports, popular scientific, tv, opinion/ news, and teen magazine. it has been argued that various new media, such as social media, blogs, and websites, have become important sites of information exchange, social support, and even mental health service itself (giles & newbold, ; lal & adair, ; moorhead et al., ) . nevertheless, newspapers can still be considered mainstream in the sense that they remain influential in the construction and dispersion of public understandings of mental health (chadwick, ) , or, as briggs and hallin ( ) stipulate, in "setting the terms of public debate" (p. ). our search was limited to the online content of the sources with the aim of developing an online database to store the collected data. as we collected both freely accessible articles and articles that were behind a paywall, we had access to largely the same content of the paper versions of the sources. moreover, given the fact that in , more than nine out of households in the netherlands, sweden and norway, more than eight out of households in belgium and cyprus, and more than three out of four households in greece had internet access (eurostat, ), we believe that online information (especially of mainstream media sources) represents not an exhaustive, but a representative sample of all information content in the particular countries. given the various ways to name mental health (problems), we used a broad range of key terms that were scanned for in all text, including "mental health," "mental wellbeing," "mental illness," "mental disorder," "psychiatric problems," "psychological issues," as well as the names of specific mental health issues, such as "depression," "burn-out," "schizophrenia," and "bipolar disorder." data collection covered a period of weeks between september and october resulting in a data set of articles. table presents an overview of the collected data for each of the six european countries. all of the newspaper and magazine articles that mentioned one of the key terms were included in the study and were descriptively coded using the following tags: title, date, language, and abstract (one-sentence summary) of the article, "who speaks" in the article (e.g., academic scholar, celebrity, professional), target group (e.g., adolescents, women), mental health issue (e.g., depression, burn-out), newspaper section (e.g., science, lifestyle, opinion piece), and key terms evident in the article. based on the reading and descriptive coding of the articles, each country identified the five main topics in their public mental health debates. an overview of these topics is provided in table . we selected a smaller subset of data for the interpretive analysis of the cultural understandings of mental health/ illness and the biocommunicable cartographies produced and circulated in the newspaper and magazine articles. each country selected five representative articles for each of their five main topics. to include less dominant perspectives, all countries also selected an additional five articles that did not belong to any of the five main categories. this resulted in a data set of articles. our interpretive analysis specifically builds on the field of rhetoric as a methodological framework. in line with discursive studies of "mental health/illness," a rhetorical analysis attempts to account for the complexity in how people make sense of "mental health/illness" and associated service use (sims-schouten & riley, ). rhetorical studies of mental health communication, however, are particularly concerned with how certain understandings of mental health/illness become persuasive and thus productive in the constitution of the healthy subject, and how and why they appeal to specific audiences that are either already there, assumed, or created (dumit, ) . in this study, we conducted a rhetorical cluster-agon analysis to (a) first identify larger patterns in the media sources' cultural construction of mental health/illness and (b) then gain deeper insight into the rhetorical strategies that are used to persuade people of both these understandings and their concomitant biocommunicable positions. the first stage of the analysis thus takes a more inductive approach and examines what understandings of mental health/illness mainstream media currently rely on, while the second stage more deductively draws on the framework of biocommunicability to explain how these understandings of mental health/illness are rhetorically constructed and how they persuade the audience of specific ideas on who produces, circulates, and consumes valuable and legitimate mental health knowledge (cf. mental health literacy) (on the importance of using qualitative methods to understand both the what and the how of health communication, see foley et al., ) . the analytical method of cluster-agon analysis is primarily based on the assumption that when we communicate, our terminology comes together in associational clusters (burke, ) . the analysis then, is aimed at identifying "what goes with what" (positive terms, such as synonyms, characteristics, comparisons) and "what goes against what" (negative or agon terms, such as negations, terms in competition, or at odds with each other) in these clusters and how these linguistic patterns (re)produce certain understandings of reality (foss, ) . a cluster-agon analysis consists of three steps. first, the key terms of the rhetorical action have to be determined, which in our case corresponded with the search terms each article was tagged with during the descriptive analysis (e.g., mental illness, mental wellbeing, depression, and so on). next, the researcher examines the contexts in which the key terms occur and identifies the terms that positively and negatively cluster national and international trends related to mental health issues around the key term in these contexts. to interpret what terms are most meaningfully associated with the key terms, the principles of frequency, location, and emphasis can be applied. in a third and final step, the text is interpreted by discerning wider discursive patterns in the associations or oppositions discovered in the clusters (for a more extensive explanation, see foss, ) . to deal with the issue of analyzing materials in different languages, each researcher analyzed the articles of their geographical area individually for the first two steps of the rhetorical cluster-agon analysis and then reported on the results in english by providing an overview of each article's key terms, positive clusters terms, and agon cluster terms using a shared template. the third step of the analysis was performed by the researchers with expertise in the domain of rhetorical and discursive studies and was reported back to the research team to make sure the findings of the study aligned with the rest of the team's interpretations of the data. we identified four dominant terminological clusters in the newspaper and magazines' mental health reporting, with mental health/illness conceptualized in terms of (a) danger and risk, (b) a lifestyle issue, (c) a unique story and experience, and (d) social trends and factors. below, we describe how each of these understandings is rhetorically constructed by discursively associating and disassociating specific groups of cluster terms. we also elaborate on how each of the clusters communicates specific ideas on what counts as valuable mental health knowledge (cf. mental health literacy) by relating them to the three models of biocommunicability. in each of the six countries' public mental health debates, we identified a cluster that approaches mental health problems in terms of danger, risk, and violence. this cluster is most apparent in news articles that relate mental health problems to (pseudo-)criminal activities, with the terminology used to refer to people with mental health problems ranging from judicial language (e.g., the accused, the offender) to biomedical language (e.g., psychiatric patient) and language that relates to madness (e.g., a disturbed person, a sick mind). interestingly, these terminologies do not appear as the agon of one another, but instead paradoxically intersect. for example, in one article, a woman who struggles with mental health problems is referred to as both a "notorious troublemaker"/"attacker" and a "vulnerable psychiatric patient"/"sweet lady." especially in the case of serious crimes that seem to have no clear motive, such as a parent murdering a child or a very young perpetrator committing a violent crime, news reports ambiguously draw on terminology that refers to both determinism and agency. statements such as "there was no intention or motive," "i wasn't myself," or "i couldn't control my impulses," suggest a passive role for the individual involved and instead consider mental illness to be both the explanation and the agent of the action. still, individual responsibility is implied as is illustrated in terms such as "remorse," "apologize," or "mental illness is used as an excuse." a more explicit reference to the assumption of agency can be found in judges' or journalists' indication that the person who committed a crime did not seek psychological help in time or did not take their medication on a regular basis (table ) . the association of mental health issues with danger, risk, and threat is a trope that, as holland ( a) notes, is not specifically accounted for in the model of briggs and hallin ( ) which focuses on the issue of health news more generally. however, our data suggest that news coverage that relates mental health problems to crime is still largely informed by the biocommunicable model of biomedical authority, with most of the terminology surrounding the concept of mental distress referring to biomedical psychiatry (i.e., illness, disorder, diagnosis, treatment, medication, and psychiatric expert). interestingly, within this cluster, the biomedical authority model might work as both a destigmatizating force by taking away part of the blame and responsibility for the crimes committed, and as a stigmatizing force by reinforcing conceptions of mental illness as medical dysfunctions that cannot be remedied. the language reflecting the agency of the person with mental health problems illustrates that the patient-consumer model operates in this cluster as well. by associating crime and punishment with reluctance to turn to professional help in time or to take one's medication in a responsible way, news stories on crimes committed by people with mental illnesses can function as examples of biocommunicable failure to manage one's mental health. another group of articles that reinforces both the biomedical authority and the patient-consumer model by relating mental health problems to danger and risk, consists of news reports that disseminate recent research findings on what increases or decreases the possibility of developing mental health problems. central to the terminology of these articles is the concept of "risk," that functions to present mental illness as an ever-present threat to "healthy individuals" and "healthy societies." in line with the biocommunicable model of biomedical authority, journalists generally take on the role of passing on scientific expert knowledge on what constitutes a "risk profile" or who belongs to a "risk group" to a not-yet-knowing audience. specific demographic groups, in our data mostly adolescents, the elderly and (pregnant) women, are singled out as "especially vulnerable" and thus especially responsible to manage their risk of developing mental difficulties. only very rarely, journalists comment on the fact that there is no consensus on the validity of certain research findings yet among scholars and (mental health) professionals. our cluster analysis furthermore shows that scientific terminology often intersects with neurological and technological terminology to create the equation that more technology equals more individual, neurological, statistical data which, in its turn, is assumed to lead to less risk of mental health problems and thus healthy individuals and healthy societies (table ). in several news articles, economic interests are integrated in the formula as well, with the costs of persons who experience mental health problems (in terms of economic, social and human capital) presented as posing an economic threat to healthy societies. although the first cluster mainly focuses on "mental illness" or "mental health problems," this cluster emphasizes the importance of actively pursuing "mental wellbeing," "quality of life," and even "happiness" (table ). in the public mental health debates, the first and second cluster often do not operate as each other's agons. rather, they intersect in prevention logics that take the individual as their primary object of intervention and that are heavily embedded in the patient-consumer model of biocommunicability and its notion of the enterprising self. within this cluster, news articles encourage the general public to actively manage their mental health, with the key to a healthy mental life to be found in a healthy lifestyle, which includes healthy eating habits, healthy sleeping patterns, physical exercise, and a responsible use of technology and social media. the strong presence of lifestyleterminology (way of life, life attitudes) in conjunction with self-terminology (self-improvement, self-care, self-regulation) suggests that taking care of one's mental condition is not only primarily a responsibility of the individual, but also a lifelong commitment. within this cluster, mental health literacy appears as a prominent aspect of mental health care and is conceived of as a pedagogical project with news and magazine articles "informing" and "educating" the audience with "tips," "tricks," and "advice" on how to maintain a healthy lifestyle. although this lifestyle journalism has a clear relation to the patient-consumer model, we identified examples of biomedical authority within this cluster as well. in several of the articles, the association of mental health and lifestyle is underpinned by biomedical scientific and professional expert knowledge, often invoking neurological explanations referring to the brain and hormones. nevertheless, this cluster complements traditional authoritative knowledge on mental health/illness with new sources of information, including expert advice from life coaches, labor experts, and health insurance companies, advertisements from pharmaceutical companies, and insights from people who personally experienced mental health issues. we identified examples of people sharing experiences of dealing with mental health problems with a larger public in all of the six countries' media sources. in some of the countries, these so-called "first person accounts" even dominated public discussions of mental health/illness. the term "story" and other narrative terminology seems of particular importance to people's description of their (or a friend's or relative's) experiences of dealing with mental health problems and of processes of stereotyping and stigmatization (e.g., "everyone has their own story," "see the story behind people," or "don't judge a book by its cover"), which emphasizes the subjective and personal dimension of experiencing mental health problems. indeed, the testimonials often do not conceptualize mental health problems from a single perspective, as is reflected in the biopsychosocial terminology in this cluster (cf. terminology referring to the bodily, psychological, emotional, and social dimensions of mental health problems). likewise, a variety of potential sources of support are mentioned, including professional help from a family doctor, therapist or psychiatrist, psycho-pharmaceuticals, alternative therapies, and nonprofessional help such as support from friends, family or fellow-sufferers/survivors, and self-care. a closer examination of the testimonials reveals that several stories are built around a linear "made it"-narrative: after people's journey to find the help most suited for them, they reach a point of "peacefulness" or "stability" and "finally feel like themselves self again." such "redemptive story turning points" have been considered important in the process of regaining personal agency (kerr et al., ) . however, one of the messages conveyed to the audience in such stories seems to be that everyone can find out "what works for them," which resonates with conceptions of biocommunicable success within the patient-consumer model. indeed, in one of the news articles, a scholar critiques the "conditional openness" of media toward stories that fit certain "feel good"-narratives. occasionally, we found the third cluster to intersect with the first and second one in articles that report on people's successful attempts to prevent mental health issues (see titles such as "i almost suffered from a burn-out"; table ). understandings of mental health issues in terms of personal stories or experiences also adhere to the more emancipatory dimension of the patient-consumer model as they validate the experience of service users/survivors as a legitimate source of knowledge on "what works best." various testimonies question the dominance of the biomedical psychiatric perspective as the only or most authoritative form of knowledge on mental health problems. they display ambiguous attitudes toward the use of pharmaceuticals, mention negative experiences with professional help or share stories about the beneficial effects of alternative therapies and nonprofessional help. some of these more critical testimonies explicitly speak from a public sphere model of biocommunicability and address their critiques directly to the mental health care system and the politicians, policy makers and professionals behind it (on this, see also cluster ). in most cases, however, the "experience" (or "proximity" in the case of relatives or friends) of people dealing with mental health issues works as a form of "knowledge" or "expertise" to convince people with similar experiences that change is possible and that there is no shame in asking for (professional) help. "knowledge by experience" is ascribed both an informative and a supportive role, as is evident from expressions such as "our insights are like medicine" or "hearing and sharing stories can be therapeutic." in addition, it is engaged with as a means to break persisting stereotypes and taboos surrounding mental health problems and to create a climate in which mental health issues can be talked about more openly. a major rhetorical strategy deployed in the testimonies' antistigmatization work, is the establishment of a process of identification with the readers, emphasizing throughout the stories that people with mental health issues are actually "just like you," that "we are all humans" and that "everybody struggles." interestingly, on some occasions, attempts to identify with the larger public coincide with the creation of new divisions. especially in the case of mental problems such as depression, anxiety, and burn-out, people sometimes emphasize the importance of opening up about mental struggles, yet cluster terms that focus on the individual individual behavior, you, personal, self-care, self-regulation, selfimprovement, self-awareness, self-esteem cluster terms that focus on orientations to act " signs that . . . ," warning signs, " tips to . . . " tricks, advice, advertisement, improve, succeed, reach outcomes and goals, make choices, recognize, prevent, manage, coach, protect, counteract cluster terms that focus on pedagogy educate, train, psycho-education, education, parents, increase your knowledge intersection with economic cluster terms economic interests, profitable, productivity, work, labor expert, efficient, consumers, market, invest, social/human capital, expensive, societal costs, medical costs, destruction of resources intersection with neurological cluster terms brain, neurotransmitters, neuroscientist, hormones, dopamine shots, serotonine, melatonine, brain activity, exercise your brain, a quick and sharp brain, brain development note. adhd = attention-deficit/hyperactivity disorder. simultaneously reassure the audience that they are "not crazy." the language of "craziness" or "madness" is also apparent in some of the more sensationalist media reports "revealing" the mental health problems of celebrities, turning their "confessions" into objects of curiosity and entertainment for the audience (see, for example, clickbait titles such as "doctor, i am crazy and i am dying: greek singer shocks!"). although in the three previous clusters, the individual is most prominently featured as the object of attention, the fourth cluster focuses on the social dimension of mental health/illness (table ) . since this cluster does not have a specific thematic focus, we will elaborate on three topics that frequently recurred, each of them characterized by a specific set of associated cluster terms. the first topic concerns critiques on the organization of the mental health care system, in most cases formulated by (mental health) professionals or service users/ survivors. the problems most frequently targeted in the critiques include the inaccessibility of mental health services, waiting lists getting longer due to a lack of care accommodation, and the system's overreliance on medication as a quick fix for complex psychological problems. politicians, policy makers, pharmaceutical companies, and medical professionals are explicitly addressed as the audience of the critiques, with calls to increase the government's mental health care budget, to develop carecentered instead of administration-centered policies, and to educate professionals on the value of various therapies. the terminology in this cluster pinpoints attention to a question that is often left out in the previous clusters, namely, whether we can guarantee that a person that wants to be helped professionally will be able to find and access appropriate care. this not only raises the question whether our mental health care system allows people to take on the role of the active and empowered patientconsumer, but, on a more fundamental level, challenges the notion as such. for example, in cases where people who need professional help distrust the system (e.g., due to psychotic episodes), putting the responsibility to ask for and find professional help mainly with the individual in mental distress (and their close environment) might hamper their chance of getting the appropriate care. the second topic that draws on social terminology in its discussion of mental health, concerns the identification of societal trends that might impact the wellbeing of the general population. high pressure workplace environments as well as technological developments, social media, and the concomitant expectation of always being available are singled out as leading to "a tsunami" of stress, burn-out, anxiety, and depression. although some articles complement their analysis with calls on employers to develop wellbeing policies or with a more radical rejection of our "performance society" altogether, others turn their attention to the individual again, asking "what we can do to live a life that is free of technostress?" or arguing that "changing our reactions to culture can be liberating." here again, appeals are being made to the "enterprising individual" that, once informed about the social risks threatening its wellbeing, will be able to make the right health choices (see also cluster ). finally, a small number of articles discusses how social inequalities and power differentials in our societies affect the mental wellbeing and mental health care of marginalized groups. furthermore, some articles critique how in current political and ideological debates people who struggle with mental health issues are portrayed as threatening out-groups (together with, for example, people who suffer from drug addiction or prostitutes) as a way to rationalize their exclusion from a society that is not capable of-or not willing to-provide basic needs for the most vulnerable members of its population. the terminology used in these articles differs from the terms traditionally dominating public discussions of mental health/illness. for example, instead of "stigma," concepts such as "discrimination," "violation of rights," and "social exclusion" are used to describe experiences of repression, criminalization or exclusion in society and the mental health care system. orientations to act shift from "hearing and sharing stories as therapy" to "activism," "advocacy," and "political awareness as therapy" with specific attention being paid to the material realities in which people are expected to take care of their mental wellbeing. these articles contained the most outspoken references to a public sphere model of biocommunicability with the unusual targeting cluster terms "mental health care system" mental health system, mental health services, mental health care, waiting lists, no accessibility, no availability, lack of care accommodation, not enough treatment capacity, unacceptable, illegal use of force and isolation cells, medication as quick fix, over prescription and overuse of medication, pharmaceutical companies, selling illness, bureaucracy, market forces in care system, constant monitoring, administration, hold politicians accountable, government fails, participation society fails, policy, financing, budget, resources alternative help circuit (e.g., care farm), person centered care, care time, care centered policy cluster terms "societal trends" technology, social media, facebook, whatsapp, work mail, technostress, information society, labor market, stress, high pressure, high expectations, performance society, neoliberal society, productivity, tsunami of burn-outs, burning boomers, generation z, psychological problems or our time cluster terms "societal power differentials" "experts in discrimination", discrimination, inclusion, diversity policy, violation of rights, democracy, social exclusion, repressive policies, intersectionality, power, politics, marginalized population, equal citizens, government advocacy organizations, voice, activism, organized actions, political awareness as therapy power imbalance and tackling societal issues, unequal society, socioeconomic living conditions, health insurance, financial poverty, neoliberal conservatism, capitalism, productivity, disposable people "experts in therapy," lack of training in "stigmatized identities" chemical imbalance and treating symptoms psychological problems of politicians, policy makers, and mental health professionals as the objects of pedagogical or literacy interventions in which they need to learn from "experts in discrimination." interestingly, in some articles the term "psychological problems" appeared as an agon term, reminding the audience that not all problems can be reduced to individual mental distress and that in some cases "tackling societal issues and power imbalances" rather than "treating symptoms or chemical imbalances" might be the more appropriate way to act. in this study, we examined media coverage on the topic of mental health problems and mental wellbeing in a broad range of newspapers and magazines from six different european countries. we specifically analyzed how the discursive association and disassociation of cluster terms (cf. "what goes with and against what") creates specific understandings of what constitutes the mentally healthy or ill subject. drawing on the framework of biocommunicability, we furthermore sought to examine how each of the clusters relates to the concept of mental health literacy and persuades its audience to take up particular attitudes toward mental health (knowledge). our findings illustrate that public discussions of mental health/illness inevitably draw on terminological clusters, with the clusters of "mental illness as dangerous," "mental wellbeing as a matter of lifestyle," "experiencing mental health problems as a unique story," and "mental illness as socially situated" being the most dominant in our data. while some news and magazine articles clearly aligned with one of the four clusters, we identified many examples where different clusters and biocommunicable models intersected to create complex, sometimes paradoxical, terminological and biocommunicable cartographies. these findings suggest that particular discourses can function differently in public mental health debates and that they cannot be unambiguously judged as either exclusively problematic and stigmatizing or exclusively good and empowering. we argue that the method of rhetorical analysis might respond to the methodological challenge to capture the nonlinear and complex effects of specific discourses on public understandings of and attitudes toward mental health/illness (briggs & hallin, ) , since the rhetorical and productive power of psy-discourses precisely lies in the fact it might accommodate multiple interests (thornton, ) . in our analysis, we indeed identified several examples of the complex and multiple workings of specific discourses (or terminological clusters) in relation to topics such as stigma, empowerment and mental health literacy. for example, discourses of dangerousness and risk, sometimes in coalition with discourses of sensation, were clearly present in our data. this is in line with previous research findings (nairn, ; sieff, ) and was perceived as negative and conforming stereotypes of people with mental difficulties being out of control in many of the first person accounts. although mainstream media thus contribute to the persistence of negative stereotypes, they also take an active role in counteracting them with the taboo-breaking first person accounts appearing as one of the most dominant types of mental health reporting in several of the six countries. the biomedical "mental illness as a disease like any other" approach was often engaged as a tactic to normalize mental illness and taking psycho-pharmaceuticals in particular in these narratives. however, research has shown that increased medical literacy does not necessarily result in increased social acceptance of people with mental illness (schomerus et al., ) and might even strengthen ideas of dangerousness and unpredictability (read et al., ) . our analysis of the crime reports provides an apt illustration of this double rhetorical effect of stigmatization and destigmatization of biopsychiatric and medical discourse. in many of these articles, concepts such as "diagnosis" and "illness" functioned to take away blame, yet also coincided with punitive, law and order, and criminalizing terminology as they strengthened deterministic beliefs that "this person will not change" and "there is too high a risk of relapse." inviting empathy and understanding is considered to be another effective rhetorical strategy of anti-stigmatization and normalization in mental illness narratives (lewiecki-wilson, ) . in our study as well, establishing identification with the audience was central to many of the first person accounts' efforts to normalize the experiences of people with mental health problems. in a few cases, however, people's identification attempts coincided with a reassurance of the audience that they were "not crazy," implying a hierarchy between more and less socially acceptable mental health problems. although our data did not contain explicit references to mental problems considered to belong to the last category, most of the personal narratives and lifestyle advice focused on burnout, depression, suicidal thoughts, anxiety, and mental health problems in general, with bipolar disorder, psychosis, and schizophrenia less frequently or not at all openly discussed. similarly, a study of newspaper coverage on mental illness in the united kingdom indicates that in the past decades coverage for depression has become less stigmatizing, but has remained largely negative for schizophrenia (goulden et al., ) . this could possibly be explained by mainstream media's tendency to sanitize mental health news and focus on upbeat and safe narratives that largely fit biomedical authority and patient-consumer conceptions of biocommunicable success (holland, a) , rather than on stories about schizophrenia and psychosis that have long been associated to "classical madness" (wahl, , p. ). one a more fundamental note, rothfelder and thornton ( ) question whether empathy and understanding are unambiguously desirable rhetorical effects at all. they remark that the growing acceptance and popularization of the term obsessive compulsive disorder (ocd) (cf. expressions such "i am so ocd as well") might have some unproductive effects, such as too simplistic and unquestioned understandings of what ocd is and what it means to live with it. rather than focusing our communication exclusively on empathy and acceptance, we should be more sensitive toward the critical potential of "rhetorical acts that do not seek uncomplicated acceptance or understanding from their audiences" as tools of antistigmatization and resistance (rothfelder & thornton, , p. ) and should look into the diversity of reasons people have for choosing whether or not to disclose their mental health issues (bril-barniv et al., ) . in the same way discourses play various roles in the rhetoric of (de)stigmatization, they can perform differently in the rhetoric of empowerment as well. the findings of our study largely confirm briggs and hallin's ( ) argument that, in the context of (mental) health, current understandings of empowerment are largely embedded in patient-consumer models of biocommunicability, which emphasize client/consumer-centered practice and individual decision-making as leading principles of (mental) health care. similar to the case of biopsychiatric discourse, juhila et al. ( ) argue that empowerment-discourse gains its power from its potential to underpin varying projects of change in current welfare states and services. in our data, logics of agency (e.g., notions of "expertise by experience" in personal narratives) intersected with logics of consumerism (e.g., media presenting a healthy lifestyle as a commodity to be purchased by their readers) and individualization (e.g., translating social problems to problems of individuals being at risk), to create understandings of empowerment that simultaneously affirm the audience's autonomy to make choices and their responsibility to make the right choices. these discourses of responsibilization often prioritize the notion of mental health literacy over mental health service and focus attention to the information and knowledge gaps of individuals or the general public rather than the social and materials contexts in which individuals are expected to monitor their mental health (esposito & perez, ; teghtsoonian, ) . we did encounter some resistance toward these discourses within the fourth cluster, which tried to change the scope of analysis and intervention from the individual to the collective and societal level as well as within some of the personal narratives which addressed shortcomings in mental health practice and policy, rather than in the general public's mental health literacy. although patient-consumer models heavily impacted understandings of empowerment and mental health literacy in our data, there was a clear presence of the biomedical authority model as well, especially in the form of neuro-discourses. we did not elaborate on the bio-neurological perspective as a separate cluster since it nearly always appeared in conjunction with the three first clusters. dumit ( ) notes that neurological conceptions of mental illness have become so persuasive that the brain has almost become a synecdoche for one's identity. when combined with the autonomy as responsibility-logic, this leaves people with the difficult choice between the "toosimple cultural alternatives of either being responsible for your sickness or not being your brain" (dumit, , p. ) . our data did indeed contain some evidence of people trying to negotiate understandings of their neurological (rose, ) or pharmaceutical (dumit, ) selves, balancing between understandings of their mental health problems as "a part of them" versus as "a brain dysfunction that needs to be fixed with medication so i can be myself again." this again reminds us that we cannot simply judge specific discourses as either stigmatizing or empowering and that we need to understand the choices of people with mental health problems to self-identify in certain ways within larger sociocultural understandings of what constitutes good and healthy citizens. this article has aimed to contribute to the field of critical (mental) health communication studies by examining how newspapers and magazines actively mediate public understandings of mental health/illness and simultaneously communicate ideas on who should produce, circulate, and receive mental health knowledge. our analysis of the performative effects of the terminological clusters that underpin public discussions of mental health/illness revealed that we cannot take for granted the straightforward destigmatizing or empowering effects of biopsychatric discourses or discourses aimed at empathy and understanding. we consequently argue that, rather than searching for the ultimate correct and destigmatizing mental health/illness knowledge and discourse, health communication research should examine how discourses work differently in varying contexts and how they might be productive in both the formulation of positive selfidentifications and in the creation of new lines of division and exclusion. in addition, such a "discursive awareness" might be relevant for clinical practice as well, since professionals might become "mindful of the effects of their use of language and make the contingent nature of their knowledge explicit" (lofgren et al., , p. ) . one of the limitations of this study is its restriction to a -week period of news coverage, which means that specific topics might have been overrepresented or missing in our data. however, as our aim was not to track down changes over time in media coverage of mental health/illness, we contend that our data set was comprehensive and diverse enough to allow us to gain insight into larger terminological patterns and complexities in current mental health/illness reporting. in line with lynch and zoller ( ) , we furthermore contend that methodological perspectives from the field of rhetorical studies might offer valuable contributions to the field of health communication, especially because of its potential to study how language constructs specific cultural understanding of health, illness and literacy and how, at particular moments, these constructions become persuasive to particular audiences and particular causes. we confined our analysis to the empirical study of written, online mental health news. however, future studies might fruitfully draw on the framework of biocommunicability and the method of rhetorical analysis to study how cultural understandings of mental health (literacy) are constructed in a variety of other empirical contexts, such as service users' activist and advocacy work, policy documents, or professional discourse. since research has shown that dynamics of media coverage and stigmatization might be different for specific mental health issues, future research might also study the rhetorical effects of specific discourses for specific mental health problems, such as depression, burn-out, or schizophrenia. in addition, although this did not fall within the scope of this study, future research might apply comparative methodologies to gain insight into the potential impact of political, economic and cultural contexts on media coverage of and main themes about mental health within countries. finally, we suggest that mental health awareness campaigns and mental health literacy policy initiatives broaden their scope from focusing on the need of the general public to educate themselves on one form of mental health knowledge to the need for everyone, including journalists, policy makers, professionals, service users, and researchers, to develop a critical mental health literacy, which includes a critical meta-awareness of the ways in which we are all confronted with various cultural constructions of mental health/illness, and "recruited to take our assigned roles in producing, circulating, and receiving health knowledge" (briggs & hallin, , p. iv) . ine de neve works as a research assistent at the department of experimental clinical and health psychology. her research focuses on the perspectives of clinical professionals on the current and prospective belgian mental health care. mattias desmet works as professor and lecturer of psychoanalytic psychotherapy at the department of psychoanalysis and clinical consulting at ghent university. his research focuses on the process and outcome of psychoanalytic psychotherapy. alexis dewaele is professor and coordinator of psync, a consortium within the field of clinical psychology, at ghent university. his research interests include sexual health and identity, social networks, stressors in minority groups and mental wellbeing. theodoros giovazolias is associate professor of counselling psychology at the department of psychology at the university of crete. his research interests include family issues, parent counselling and bullying and victimization. dewi hannon works as a research assistant at the department of experimental clinical and health psychology at ghent university. her research focuses on therapeutic change in the treatment of medically unexplained symptoms. organizational psychology at the psychology department, university of crete and director of the applied psychology laboratory. he is also affiliated to the aristotle university of thessaloniki. his research interests include emotion in interpersonal and social interaction, in hierarchical relationships at work, and in social relationships across cultures. reitske meganck is professor and lecturer of clinical psychology at the department of psychoanalysis and clinical consulting at ghent university. her research interests include the process and outcome of psychoanalytic psychotherapy using mixed method designs in group and single case research. simon overland is adjunct professor at the university of bergen and leads a team of researchers analysing burden of disease and risk factors at the norwegian institute of public health. his research interests include population health, mental wellbeing epidemiology and general public health. sofia triliva is associate professor of clinical psychology at the department of psychology at the university of crete. her research interests include identity formation 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psychiatrica scandinavica health and media: an overview media frames of mental illnesses: the potential impact of negative frames presenting critical realist discourse analysis as a tool for making sense of service users' accounts of their mental health problems depression and mental health in neoliberal times: a critical analysis of policy and discourse critical psychology: a geography of intellectual engagement and resistance race, risk, and pathology in psychiatric culture: disease awareness campaigns as governmental rhetoric. critical studies in media communication media madness: public images of mental illness public mental health: the time is ripe for translation of evidence into practice theoretical contributions of interpretive and critical research in health communication konstantinos kafetsios is also affiliated with aristotle university of thessaloniki, thessaloniki, greece. the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. the authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this work was supported by the european parliament (grant pp- - , topic: pp- - - ) and the ghent university special research fund (doctoral scholarship bof- -doc- ). laura van beveren https://orcid.org/ - - - dewi hannon https://orcid.org/ - - - notes . we recognize that, according to theoretical or political position, terminological preferences to refer to "mental health (issues)" and "service users" can differ. in this article, we will use varying terminology mainly trying to remain as closely as possible to the specific terms used in the public debates and the literature we study. . definitions of "most read" differ according to the information available in each country, for example, highest number of (online) subscribers or highest number of sold copies. laura van beveren works as a doctoral researcher at the department of educational studies at ghent university. her research interests include rhetorical analysis and critical reflection in clinical psychology. key: cord- -zvb bxix authors: connolly, john title: the “wicked problems” of governing uk health security disaster prevention: the case of pandemic influenza date: - - journal: disaster prev manag doi: . /dpm- - - sha: doc_id: cord_uid: zvb bxix purpose: the purpose of this paper is to examine the governance and policy-making challenges in the context of “wicked problems” based on the case of pandemic influenza. design/methodology/approach: the case study research is based on an analysis of official documentation and interviews with policy elites at multiple levels of uk governance. findings: results of this study show that policy actors regard risk communication, the dynamics of international public policy and uk territorial governance as the main governance challenges in the management of influenza at a macro-level. the paper also serves to identify that although contingencies management for epidemiological issues require technical and scientific considerations to feature in governance arrangements, equally there are key “wicked problems” in the context public policy that pervade the health security sector. practical implications: the study indicates the need to build in resources at a national level to plan for policy coordination challenges in areas that might at first be seen as devoid of political machinations (such as technical areas of public policy that might be underpinned by epidemiological processes). the identification of the major governance challenges that emerge from the pandemic influenza case study is a springboard for a research agenda in relation to the analysis of the parallels and paradoxes of governance challenges for health security across eu member states. originality/value: this paper provides a novel interrogation of the pandemic influenza case study in the context of uk governance and public policy by providing a strategic policy lens from perspective of elites. in april the british public were reminded that pandemic influenza (flu), in the context of health security, continues to be a major concern for uk policy-makers. there is recognition by the uk government that a pandemic remains the top health risk for the population (nhs england, ) . the risk of pandemic flu has come into the spotlight recently due to the fact that key measures to prevent such a diseaseinduced disaster may not be effective. a review of the effectiveness of tamiflu [ ] (the main contingencies measure to manage a pandemic) produced by the cochrane collaboration ( jefferson et al., ) , referred to in the rest of this paper as "cochrane review", in the uk concluded that tamiflu had no significant impact on reducing hospital admissions and does not serve to prevent the person to person spread of influenza. this led to pharmaceutical companies retorting by questioning the reliability and validity of the review. uk health authorities responded by insisting that investing in tamiflu remained "a good insurance policy for the population" . the debates around the cochrane review (which are often scientific and epidemiological in nature) also served to highlight the public policy-orientated challenges to managing health security threats such as a pandemic. this paper seeks to delve into the public policy aspects of contingencies management for disease threats from the perspective of policy elites based on the case study of the influenza pandemic in the uk. the paper addresses a lacuna in uk disaster and crisis management literature by contributing to the "governance" aspects managing health security. there are studies which consider crisis management, resilience and risk in the context of uk public policy (e.g. mcconnell, ; drennan and mcconnell, ; brassett et al., ) , however, there are very few case-based research studies which illustrate crisis and disaster governance challenges from the perspective of those institutions and policy actors that are responsible for managing such "wicked problems" from a macro-level policy position. from a public policy point of view, pandemics represent challenges that are unstructured, relentless and cross-cuttingall hallmarks of a wicked problem (weber and khademian, , p. ) . first, as weber and khademian ( , p. ) note, issues that can be viewed in this way are unstructured given that there are high informational demands, there is not always a clear solution to the problem and they have multiple ripple effects. second, the relentlessness of such problems emerges as a result of the fact that the fight is never over and a line cannot be drawn under themthere is no finality. third, cross-cutting refers to the fact that wicked problems involve multiple stakeholders who have a range of views and knowledge within a complex political and economic context. the complexities of disease threats and their transcendence of systems elucidates the fact that health security and pandemic prevention involves trade-offs, require flexibility, resource sharing and collaboration to ensure policy success (durant and legge, ) . other examples of wicked problems include responding and managing climate change, social justice, drug trafficking, immigration, and epidemics. pandemic influenza fits with the notion of a wicked problem given that they call for multi-level and multi-actor responses across territories requiring a high degree of resilience to deal with the contours of the disease (unstructured and cross-cutting). at a population level the risk of a pandemic endures over time as a result of the mutation of disease strains and the impact of pandemics can traced over many years (relentless). indeed, policy-makers are well aware that in the last century alone the , and influenza pandemics have contributed to millions of fatalities as well as vast economic and social disruption (kamradt-scott and mcinnes, , pp. - ) . the case of pandemic influenza is a "way in" to understanding the policy dynamics of the health security sector in the context of disaster research. the issues to emerge from pandemic influenza are likely to have consequences for the governance of other diseases (and, naturally, reference to other diseases will be made in this paper given policy responses to specific diseases do not exist in a vacuum). the question that underpins the paper, therefore, is: what does the case study of pandemic influenza tell us about what policy elites regard as the key "wicked problems" of contingencies management in the context of uk governance? the case study has been interrogated by deploying mixed qualitative methods. the case study method is effective in public policy research for exploring, assessing, conceptualising, and refining explanations for the characteristics and dynamics of social realities or events (lowi, , p. ; eckstein, , pp. - ; flyvbjerg, , p. ) . the approach included a thematic analysis of secondary sources and official government documentationincluding the and house of lords reports into pandemic influenza (hl- , ; hl- , ), the department of health (doh) national framework for responding to an influenza pandemic (doh, ) , the independent review of the influenza pandemic (cabinet office, ), the uk influenza pandemic preparedness strategy (doh, ) and reports of the european commission. the research also involved undertaking in-depth semi-structured elite interviews with policy actors who occupy strategic-level governmental positions in scotland, the uk and in the european commission (the commission being the main policy initiator at the eu level). the analysis of documentation served to support the identification of interviewees and contributed to the themes that structured interview schedules. the interviewees were purposely sampled due to their positions at different tiers of government in the health security policy area. the interview breakdown is as follows: scottish government ¼ interviews (subnational/devolved level); uk government (national) level: public health england (phe) (agency of the uk civil service) ¼ ; westminster/uk parliament ¼ ; uk cabinet office (central ministerial department/headquarters for government) ¼ ; and european commission (health threats unit: ). interviews lasted on average . to hours in length. the scottish and uk level interviews were face-to-face in governmental or parliamentary premises and the interviews with european commission officials took place via teleconference facilities (with the interviewer being present on university premises). there were inconsistencies in terms of the medium by which the interviews were conducted and the necessity for teleconference interviewing was borne out of resource limitations for travel (particularly the high costs for travel between scotland and luxembourg -where the officials were based in the commission). however, these inconsistencies should not necessarily been seen as limitations given that the interviews conducted via teleconference were equally rich in depth and exploratory. interviews were also sought from individuals who work in the area of public health and disease risk management in the doh, however, there was a lack of preparation by such individuals to engage with this research via an interview. the position of the department was that their institutional approach had been detailed sufficiently in strategy documentation (cited earlier in this paper). digital recordings of all the interviews were fully transcribed within hours of the interviews taking place. the interview data was thematically coded around the most significant strategic policy challenges to emerge from the data. it should be noted that the majority of the interviewees felt it to be impossible to "rank" the extent of whether one challenge outweighs another but regarded these challenges to be equally placed on a continuum of policy challenges that were present in the case of pandemic influenza. the quality of the interviews is borne out of the fact that the individuals are situated in strategic-level positions within the institutional environment under investigation (less senior officials, of which there would likely be higher numbers, would be less able to discuss strategic relations across territories). in this respect the quality of the interviews outweighs the need for quantity given the low number of individuals that are in such senior positions in this policy sector (i.e. ten interviews represents a strong sample from a small pool of available data). this approach also serves to highlight the uk health security contribution that emerges from the study in that the interviewees where able to discuss matters of macro, strategic level concern from their perspectives. the interviewees were made up of a senior uk parliamentarian (with a remit for health security) and senior officials working within the areas of contingencies and crisis management for public health at multiple levels of governance (the european commission, uk government departments/agencies and in the scottish government). in short, the paper seeks to identify where the "politics" fits in the area of contingencies and crises management from the perspective of elites in relation to health security within a multilevel governance context. the study accommodates all study protocols which were approved by the author's university ethics committee and by the funding body for the research (carnegie trust, scotland). viewing health security in the context of "disaster" in a similar vein to "crisis", no definition of disaster has been agreed upon in the literature (hood and jackson, ; perry and quarantelli, ) . alexander ( , p. ) has described disaster research as being embedded in a "definitional minefield". analyses have ranged from explaining disasters as the collapse of cultural protections (carr, ) , unique events (rubin and popkin, ), a form of collective stress (barton, ) , systemic events, and a form of a social catalyst (kreps, ) . disasters tend to be events which lead to large-scale damage to human life, damage to the physical environment and have vast economic and social costs. there is a considerable body of literature that has focused on the impact that physical (sometimes expressed as environmental) disasters have had on human activities (alexander, ; steinberg, ) . indeed, human vulnerabilities have been an important defining factor in the classification of an event as a disaster (smith, ) . again, however, there is an analytical grey area between what constitutes a crisis or disaster due to shifting identities and contextual change. for example, analyses have described a shift from threats to disasters (rijpma and van duin, ) and from crises to disasters (davies and walters, ) . the definition(s) applied to analyses seem to be dependent on the discipline using the term and the aims of the researcher because "actors create a definition with different ends in mind" (perry, , p. ) . in this respect, the "securitisation" of health, particularly around pandemic disaster prevention and management in the context of global governance, is now generally accepted by key supranational authorities (who, ; european commission, ) and in the academic literature in the context of global governance (kay and williams, ; connolly, ) . it is argued that health security can be studied and framed in the context of disaster research given that if threats of disease pandemics are not managed effectively, and safeguards are weakened, then a pandemic, and thus pandemonium, will ensueleading to far-reaching damage to human life and produce vast economic social and environmental costs on a global scale. the case of pandemic influenza in the uk the implications of pandemic influenza are "feared by politicians, health practitioners and security experts alike" (kamradt-scott and mcinnes, , p. ). significant concern of a pandemic occurring was heightened as a result of the threat of the avian flu virus in asian countries (h n virus) in and . more recently, fear about human to human transmission of influenza was particularly acute as a result of the h n "swine flu" virus. the threat emerged when the world health organisation (who) declared that there was an outbreak of swine flu following confirmation of human cases in the usa and mexico in april . two confirmed cases of pandemic influenza subsequently emerged which involved a couple who had returned to scotland from mexico (connolly, ) . this led the uk government to increase their stockpile of antivirals (tamiflu) to million (from million). the government's approach was to maintain the policy of containment e.g. through contract tracing and antiviral treatment (cabinet office, , pp. - ) . by june/july the cases of swine flu has reached almost , in countries. the cases of swine flu in the uk reached , and there were pockets of concentration of the disease in birmingham and greater glasgow (cabinet office, , p. ). the who declared the outbreak had moved to pandemic levels which triggered the uk government to procure vaccines to cover per cent of the population. in late november modellers concluded that the pandemic had peaked and a gradual reduction in cases followed (cabinet office, , p. ) . the pandemic led to [ ] deaths during the pandemic in the uk (cabinet office, , p. ). the uk response to the pandemic relied on cooperation between supranational, national and subnational jurisdictions (with uk state level being the "core" crisis management actor through the department of health phe and the uk cabinet office). following the pandemic the government produced a uk influenza pandemic preparedness strategy (doh, ) which, building on the "national framework" for responding to an influenza pandemic (doh, ) , sets out in some detail the key planning assumptions and presumptions for planning for a pandemicincluding a summary of the key roles of government departments and agencies as well as the control strategies in order to mitigate against the impact of a pandemic influenza crisis. an important point, made rather passively in the strategy, is that preparedness and response to the threat is coordinated at local, national and international levels (doh, , pp. - ; connolly, ) . the case of pandemic influenza in highlighted that disease threats, such as pandemic influenza are trans-boundary which can penetrate integrated political and economic systems (such as the european union) and, therefore, call for a large number of organisational actors, at different governance levels, to be engaged in crisis management processes (allison, ; 't hart et al., ) . the resilience literature recognises the importance of considering the implications of when crises outweigh local capacity and there is a need for a multi-level response across borders and tiers of governance (see, e.g. brassett et al., ) . there is general agreement in the literature that local-or state-centric studies of crisis, emergency management, security and risk ('t hart et al., ) need to adapt their analytical frames to consider multi-level systems (coaffee, , p. ). the study "resilience" is characterised by its inexactitude given that, as anderson ( , p. ) , notes it has been referred to in academic circles, amongst other things, as "ethos", "programme", "ideology", "concept", "term", "governing rationality", "doctrine", "discourse", "epistemic field", "logic", "buzzword", "normative or ideal concept", and "strategy of power". however, in the context of health security, we are reminded by the - global ebola outbreaks of the need for international systems to be resilient in terms of being flexible and multi-partnership focused whilst, at the same time, having clarity over institutional roles and responsibilities. this is in order to avoid disorganised and belated responses (as demonstrated by the global response to ebola). in this regard, successful resilience is dependent on being able to navigate complexity given the context of interdependences between governmental and non-state actors across multi-level uk health security and cross-cutting jurisdictional boundaries (bevir, , p. ) which necessitate inter-organisational coordination (perry and lindell, ) . as a result, this warrants the need for contingency planning needs to take place at multiple levels of governance given that internal failures can have implications for the integrated system and have disastrous consequences (see turner and pidgeon, ; boin and mcconnell, ) . these requirements are not always matched by the characteristics of bureaucratic contexts which are known for their conservatism when it comes to institutional change. what is more, conflictual and political behaviours can manifest at different levels or governance and, as a result, a lack of contestation between political and bureaucratic actors cannot be assumed (rosenthal et al., , pp. - ) . yet evidence of this is often masked by the tendency of official governmental documents (such as strategies and contingency planning documents) to be read as if contingency processes (particularly for scientific or epidemiological issues) are in some way non-political in that such documents tend to focus on a range of "manual-like" sequential steps that should be taken in the event of an incident. clarke ( ) discusses the symbolic and political nature of such crisis contingency planning by the use of "fantasy documents". it is the contention that governmental documents that attempt to tame crises or disasters are "little more than vague hopes for remote futures and have virtually no known connection with human capacity or will" (clarke, , p. ) . it is within this context that questions about the "politics" of contingencies and crisis management functions across multiple levels of governance are pursued and, specifically, how this relates to the issue of health security. the case study data indicates that balancing the activities of risk communication with pharmaceutical interests is a major governance challenge in policy-making for pandemic flu (and, arguably, for other diseases). the conclusions of the aforementioned cochrane review questioned whether government investment in a stockpile of "tamiflu" as a contingency measure to safeguard the population matched any potential benefits of taking the medication. the evidence presented by jefferson et al. ( ) suggested that tamiflu moderately reduced the period that individuals would have flu symptoms. this led to pointed media reporting of the issue which included headlines such as "drugs given for swine flu were waste of £ million" (knapton, ) and "what the tamiflu saga tells us about drug trials and big pharmaceuticals" (goldacre, ) . the response from the industry was that the review underestimated the benefits of tamiflu and that they disagreed with the statistical analyses and therefore disagreed with all of the conclusions (gallagher, ) . the uk department of health confirmed that they would not change their public health advice in relation to the use of tamiflu as part of its preparedness planning despite the findings of the cochrane review. it is with key reference to the issue of tamiflu that elite actors suggest that there are challenges with regards to risk communication and, revealingly, the chief medical officer (cmo) for scotland pointed out that "we are not very good in government at conveying the full arguments and why we have decided to continue with the current policy" (keel, ) . for policy-makers the former secretary of state for health, and latterly the chair of the uk parliamentary committee for health, highlighted the difficulties in "communicating the subtleties" of scientific evidence (dorrell, ) . this chimes with the perspectives of the cmo for scotland and the chair of phe who considered that the challenges of "coordinating and digesting advice" (keel, ) that is "unadulterated, clear, properly analysed and packaged for the policy-makers" ) are significant. the wider point here is that scientific evidence is just one consideration by policy-makers and it would almost be impossible for this to not be the case in a politically driven society . a further challenge in terms of risk communication is getting across the message that it will take at least four to six months after a novel virus has been identified and isolated before pharmaceutical manufacturers can make an effective vaccine available (doh, , p. ) . although it could be said that the provision of scientific products by pharmaceutical companies are essential, because they are the only place where new drugs and vaccines and biotechnologies are being developed, the risk for many politicians is that because they are profit-making organisations "it is easy to be accused of favouring a pharmaceutical company because of vested interests" . however, contingency planning for health security requires the need for a stockpile of drugs and vaccines but this undoubtedly remains a political decision because the opportunity cost would be that policy-makers could be accused, in the event of a crisis, of not having appropriate measures in place thus endangering the health of the public (dorrell, ) . pandemic flu served to highlight that risk communication, coupled with industry interests, need to be taken into account when it comes to the management of science-or medical-based areas of public policy. political leaders can have their fate determined by how they respond to crises (boin et al., ) , and investing in a stockpile (even if they are never used), symbolises government readiness ('t hart, ) . the uk department of health has highlighted that in a globalised world it is not possible to prevent, manage and eradicate a new virus in neither the country of origin nor when it penetrates uk borders (doh, , p. ) . it is for this reason that the current chair of ohe, writing back in , noted that reporting and responding to infectious diseases requires collaboration across territories (heymann, , p. ) . heymann ( , p. ) suggested that "[t]his phenomenon is a potential infringement on national sovereignty that compromises the concept that states reign supreme over their territories and peoples". the twin threats of sars and avian influenza served to seal a new approach to health security for disease threats within a globalised world whereby the norms to responding to public health threats are such that reporting is much more the norm in order to eradicate diseases as efficiently and effectively as possible. the rise of surveillance using the internet and international standards and agreements, such as the global influenza surveillance network (of which there are member states), overseen organisations such as the who, has now replaced a situation whereby individual states provide information on disease threats and outbreaks on a voluntary basis (heymann, , p. ) . the relationship between state actors and international policy regimes in the process of contingencies management for health security becomes ever more apparent in the context of eu public policy. the legislative competence of the eu in coordinating contingencies and crisis management arrangements for public health threats has increased after a series of serious disease episodes, such as sars, avian flu and pandemic influenza, which have presented opportunities for closer policy integration and europeanisation (ryan, ) . health security within the eu is coordinated by the directorate general for health and consumer protection of the european commission. the role of the commission has become legally enshrined since the sars outbreak which ended the voluntary arrangement in place for member states to provide data to supranational institutions uk health security (as was the case in terms of providing national level information to the who). there is now a system in place for eu level surveillance in that member states are legally required to statistically report on cases of communicable diseases through the eu health security committee on an annual basis and second, states are obliged to inform each other using an electronic system of outbreaks of one of these communicable disease which could have effects on other member states. yet, enthusiasm for closer integration between states cannot be taken for granted given that given that larger member states (such as the uk, france and germany) have their own systems of contingencies management that have strengthened over time and, therefore, "carrying smaller member states" can be a distraction (phe official, ) . there have also been difficult tensions (which is a key hallmark of "wicked problem") when it comes of the sharing of what some member states would describe as "sensitive data" with each other through the route of the health security committee when it comes to contingency planning. the reason for this is articulated by a senior european commission official: we have member states that plan to vaccinate percent of their population in the event of a pandemic. in other words, percent will not be vaccinated and then you have countries that are providing for percent. clearly if this information becomes public the citizens of the concerned countries -the percent who won't get the vaccine might have some questions to ask of their politicians. the health security committee does not oblige member states to vaccinate everybodythat's not the purpose of the exercisethis is a national decision for how many people they consider suitable or requiring a vaccination. for example it could be public service workers, it could be medical personnel, the armed services, it could be the security services. in germany it was the politicians for some reason. so this is a very political and national decision. what we have done is to take the figures from each member state and formulate a joint tender. so we now have the figures for the different member states which are quite confidential i can tell you and we will make a tender to industry and the industry will be able to apply to supply this vaccine. for senior policy-makers, the governance challenges are grouped around managing public policy dynamics around ensuring closer integration and europeanisation in the knowledge that diseases transcend borders and therefore requires collaboration across territories. however, the complexities come from the politics of using resources to support "weaker" member states and the sensitivities around sharing classified information about who will be prioritised when it comes to implementing a vaccination programme in the event of a pandemic. the wicked problem of uk territorial governance uk policy actors (i.e. in scottish and uk governments) in the area of health security have highlighted the domestic state-level challenges of managing planning for pandemic disease within uk borders and the political dimensions to this process. the uk constitutional arrangements are such that we have devolved governments (with limited powers) in scotland, wales and northern ireland. the governance challenges are complex and this is partly due to the fact that control over health policy in the uk is not straightforward. for example, in the case of scotland public health (i.e. nhs and wider healthcare) is a devolved matter, however, matters of health security that have public health implications (such as bio-terrorism) are reserved matters for the uk government. such challenges are exacerbated when administrations are headed by different political parties at different tiers of governance. for example, the scottish government is headed up by a different political administration to the uk level (the scottish nationalist party) and the case study data has shown there to be evidence that nationalist politics has impacted on approaches to multi-level contingencies management for health security (although, for pandemic influenza specifically, both uk and scottish level elites highlighted that there were strong relationships between public health officials). a scottish government official indicated how the nationalist public health minister, michael matheson, was concerned that documentation on cross-border contingencies management pertaining to health (such as radiation protection and nuclear monitoring) had the word "england" in the title as a result of the creation of "phe" as an executive agency of the uk department of health at uk level in april . this had serious implications for civil servants in scotland in that they had to research and scope out the reasons why there is not the capacity to undertake this type of work at the subnational level in scotland: the current policy arrangements are such that the devolved administrations in the uk contribute to national strategies for preparedness planning and crisis simulations, however, as one senior scottish government official noted, "it is not always the case that the devolved administrations are there and creating plans with the uk government" (scottish government official, ). interviewees from different triers of uk governance agreed that there is mutual interest in maintaining strong relationships across levels of governance both in terms of managing the spread of diseases and ensuring that clear communication channels are in place. this is not to say, however, that there are no political tensions when it comes to multi-level contingencies management for national health and security. a senior official in scottish government gives the example of counterterrorism efforts as part of the operations of the commonwealth games in glasgow . as noted above although counter-terrorism measures have implications for public health, contingencies management arrangements for terrorism are a reserved issue for westminster. this leads to multi-level tensions in terms of information sharing (even to the officials of the host country of the games) given the sensitivities around responses to terrorism: we had an exercise for the commonwealth games and cobra [of the uk cabinet office] was involved. one of the issues that people mentioned quite a lot was the counter-terrorism aspect as that is a big issue. there is an issue in terms of sharing information between parts of the administration. it is clear from such insider perspectives that there are political interests that infiltrate the approach of policy-makers even when it comes to so-called "technical" areas of contingencies and crisis management. the cmo was clear about the fact that there are interests on both sides of the border between scotland and england in terms of maintaining the current arrangements even if the devolution of more powers continues given that diseases and organisms do not stop at the border (keel, ) . in terms of the experience of managing the influenza pandemic the independent review of crisis noted that strong sub-national and national relations were not taken for granted given that "the h n pandemic was the first uk-wide crisis in a devolved policy area, and therefore there could have been inconsistencies and disagreements between the four uk nations during the response" (cabinet office, , p. ). yet the report concluded that "the willingness of the devolved administrations and the department of health to work closely together within a common uk framework was fundamental to the overall success of the response" (cabinet office, , p. ). notwithstanding this encouraging narrative, as noted above, there have been examples of nationalist fervour impacting on the public policy process in scotland which have placed demands on civil servants north of the border. there are also intriguing inter-institutional dynamics here if one considers the fact that reserved areas of public policy (which have health security implications) are legislated for in england (such as counter-terrorism policy which include measures to manage biosecurity) and the uk government can become protectionist when it comes to sharing information with subnational government despite public health being fully devolved to scotland. this serves to demonstrate that the case of public health threats fit with the perspectives of those who consider there to be an "unequal plurality" and a "predominantly asymmetric imbalance" (marsh et al., , p. ) in uk governance. this is certainly the case for the context of contingencies management processes for uk health security. the paper has provided key insights into strategic-level relationships across multiple levels of governance in relation to contingencies management policy-making for health security. it has sought to unpack some of the political multi-level policy complexities associated with managing pandemic influenza as a "wicked problem". contingency management processes in relation to this case study highlights the considerable public policy and political challenges, articulated by for policy elites, in terms of risk communication, the internationalisation and europeanisation of national contingencies management processes and uk national-subnational relations. the lens adopted by this paper, in terms of identifying the perspectives of policy elites, has emerged out of the desire to address a lacuna in uk disaster and crisis research in that there is a dearth of case-based analyses of the challenges and paradoxes of contingencies management processes from a "macro" governance position. by interrogating the case of pandemic influenza the paper highlights that the recent high profile debates over the efficacy of tamiflu instigated by the cochrane review is but one example of the governance challenges that face policy elites. from a practical point of view it is important that risk management registers (i.e. organisational systems for identifying levels of risks and countermeasures) at different tiers of governance address the management of policy and political relations across such levels and that this is continually evaluated as a result of bureaucratic coordination and conflict challenges (which are likely to emerge, in part, by constitutional reforms). this research also presents opportunities for comparative research in terms of the multi-level governance processes for contingencies management in the context of health security. this includes whether the findings of the uk experience are translatable to other state contexts with regards to the management of "wicked problems" from an elite perspective. tamiflu is the antiviral drug stockpiled by uk government to be taken in the event of a pandemic in order to alleviate symptoms and complications of influenza such as pneumonia england related to h n had been recorded, in scotland, in wales and in northern ireland confronting catastrophe: new perspectives on natural disaster towards the development of a standard in emergency planning essence of decision: explaining the cuban missile crisis what kind of thing is resilience key concepts in governance preparing for critical infrastructure breakdowns: the limits of crisis management and the need for resilience the politics of crisis management: public leadership under pressure introduction: an agenda for resilience research in politics and international relations the influenza pandemic -an independent review of the uk response to the influenza pandemic disasters and the sequence-pattern concept of social change 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new answers to old questions from accident to disaster: the response to the hercules crash the bureau-politics of crisis management disaster recovery after hurricane hugo in south carolina, natural hazards research and applications information center interview with the author in the eyes of the beholder? making sense of the systems(s) of disaster(s) acts of god: the unusual history of natural disasters in america man-made disasters wicked problems, knowledge challenges, and collaborative capacity builders in network settings foreign policy and health security an economic theory of democracy uk devolution and the european union: a tale of cooperative asymmetry pandemic influenza preparedness in the asia-pacific region serious cross-border threats to health risk and crisis management in the public sector crises and crisis management: toward comprehensive government decision making the changing world of crises and crisis management about the author the project, funded by the economic and social research council, concerned analysing the dynamics of policy and organisational change in relation to the uk animal health security sector (with particular emphasis on foot and mouth disease and avian flu). the doctoral thesis was awarded the sir walter bagehot prize by the uk political studies association for its contribution to research in public policy and administration. after completing his phd dr connolly worked as a policy adviser in the scottish public sector (nhs health scotland) and returned to academia on a full-time basis in for instructions on how to order reprints of this article, please visit our website: www.emeraldgrouppublishing.com/licensing/reprints.htm or contact us for further details: permissions@emeraldinsight key: cord- -r ii bu authors: butler, colin d.; corvalan, carlos f.; koren, hillel s. title: human health, well-being, and global ecological scenarios date: - - journal: ecosystems doi: . /s - - - sha: doc_id: cord_uid: r ii bu this article categorizes four kinds of adverse effects to human health caused by ecosystem change: direct, mediated, modulated, and systems failure. the effects are categorized on their scale, complexity, and lag-time. some but not all of these can be classified as resulting from reduced ecosystem services. the articles also explores the impacts that different socioeconomic–ecologic scenarios are likely to have on human health and how changes to human health may, in turn, influence the unfolding of four different plausible future scenarios. we provide examples to show that our categorization is a useful taxonomy for understanding the complex relationships between ecosystems and human well-being and for predicting how future ecosystem changes may affect human health. the interconnection between ecosystems and human activity is complex, important, and poorly understood. ecosystems support human health and well-being through their provisioning, regulating, cultural, and supporting services (butler and others ) . shortages of food, fiber, and other ecosystem products adversely affect human health via many direct and indirect pathways. the regulating functions of ecosystems that affect health include the purification of air and fresh water, the reduction of flooding and drought, and range limitation of certain vector-borne diseases. ecosystems also impact mental well-being through provision of cultural services, for example by providing totemic species and sacred groves, landscapes, and water bodies. these influence the aesthetic, recreational, educational, cultural, and spiritual aspects of the human experience. ecosystem changes have also altered the epidemiology of communicable and noncommunicable diseases, including through some pathways that would not be considered as arising from a reduced ecosystem regulating service. this article explores the impact that different plausible future scenarios (cumming and others ; raskin ) may have on health, and it also suggests how changes to health may feedback on and hence modify the course of the future. in doing so, we have categorized the effects of ecosystem change on human health into a useful taxonomy which can help predict which future ecosystem changes will impact human health and how. although positive scenarios are conceivable, in this article we are mainly concerned with how adverse ecosystem changes and reduced ecosystem services may harm future human health. until the very recent past, most human induced ecological changes have had favorable effects on human society and health. human health, judged by average life expectancy, has increased substantially, as has population size (riley, ; tuljapurkar and others ) . the reasons for these increases are well-known and include the mutually reinforcing and interacting elements of improved knowledge, technology, and social organization, including of public health (horiuchi ; szreter ) . a fundamental contributory factor has been the increased human capacity to modify ecosystems, for example, by increasing food supplies, by restricting populations of large carnivores, and by providing more fiber for fuel and shelter. this success is not unqualified. some adverse effects of our increased capacity to modify ecosystems on human health can already be seen. the transformation of ecosystems to provide certain benefits has reduced the scale and integrity of many ecosystems (pimentel and others ) . reduced ecosystem integrity decreases their ability to provide some ecosystem services, which can, in turn, have negative impacts on human health. this relationship is unlikely to be linear and may contain thresholds beyond which incremental loss of ecosystem services has a disproportionately negative effect on human-health and well-being. examples of the negative impacts of ecosystem change on human health abound. national life expectancy has fallen in several countries, including many parts of sub-saharan africa, haiti, russia, north korea, and ethiopia (farmer and others ; shkolnikov and others ; united nations population divisional ) . reduced ecosystem services may explain a part of these declines in national life expectancy and thus may be an underrecognized factor in the slowed rate of increase in global life expectancy. the problems of decreased provision of ecosystem services are often unequally distributed, with the majority of the burden falling on the poor. additionally, poor populations frequently lack the income and other means to substitute or partly compensate for reduced ecosystem services (for example, by boiling microbiologically contaminated water). in addition to the effect of ecosystem services on human health, human health itself influences access to critical ecosystem services and can modify the environmental impacts of human populations. for example, the aids epidemic in sub-saharan africa has reduced the provisioning ecosystem service of food supply (de waal and whiteside ) . the high prevalence of yellow fever and malaria delayed the construction of the panama canal, and sleeping sickness still limits human settlement and thereby affects human access to ecosystem services in parts of central africa (bhalla ) . a major challenge in this field is to apply real world data to conceptual models (miranda and others ) , to validate the models, and to develop approaches that can serve as a vehicle for generating hypothesis-driven research. although realization of these goals remains distant, the conceptual frameworks which will stimulate data acquisition and analysis in this field are developing (butler and others, ) . figure shows one such framework, linking natural and social systems with human wellbeing, of which health is an important component. here we introduce four categories of adverse effects on human health due to ecosystem change as a means to help understand the impacts of the different ecological scenarios on human health and well-being. in ascending order of scale, complexity, and lag-time, we call these adverse effects direct, mediated, modulated, and systems failure (see table ). we emphasize that, at their margins, these categories overlap because drivers may differ on temporal and spatial scales. figure graphically presents these concepts and provides a preliminary attempt to approximate the quantitative impact of the different categories. direct (adverse) health effects are manifested through the immediate impacts of the loss of a useful ecosystem service, such as the provision of sufficient food, clean water, fertile soil or the restriction of erosion and flooding. direct effects occur as the result of physical factors but do not include pathogens per se. miranda and others, ) climate change has recently been recognized as causing a substantial change in the lake tanganyika ecosystem. the fish catch has decreased due to a climate-related reduction in the nutrient supply (o'reilly and others ) . this reduction in ecosystem services places additional economic and nutritional stresses on an already poor and vulnerable human population. although data to measure the health effect of this reduced catch are unlikely to be available, the effect is probably adverse because it causes reduced income and reduced nutrition (verschuren ) . another example is the collapse of cod fishing in the north atlantic, which caused widespread unemployment, mental distress, and social dislocation, but little if any true under nutrition because the social mechanisms operating in canada were able to partially substitute for the lost provisioning services once supplied by the fishery. a third example of a direct health effect from a reduced ecosystem service is the disruption and physical injury caused by flooding. there is increasing recognition that floods are caused by the interaction of climatic and landuse changes (hellin and others, ; zhang and others, ) . there is also increasing evidence that mental and physical health is enhanced by contact with nature (friedman and thomas ) . reduction of the cultural services that ecosystems provide is likely to contribute to the already enormous burden of disease caused by impaired mental health. compared to direct effects, mediated effects have increased causal complexity and, in some cases, involve pathogens. some mediated effects have the potential for high rates of illness and death. there is also often a longer lag between the ecosystem change and the health outcome than for direct effects. however, by definition, mediated effects are insufficient in scale to cause the larger-scaled social collapse that we define as a modulated effect. many infectious and some chronic diseases fall in this category. the epidemiology of many communicable diseases is related to ecological factors. some major nonvector-borne diseases, including tuberculosis, measles, and influenza, are thought to have crossed into human populations because of close contact with domesticated animals (mcneil ; daszak and others, ; oxford and others, ) . changes to biodiversity may be associated with increased numbers of disease-transmitting insects. although contested, there are suggestions that malaria may also have become a significant human disease following the development of agriculture (pennisi ; joy and others ) . more recently, variant creutzfeld-jacob disease, nipah virus, and hendra virus illustrate novel infectious diseases that have entered human populations because of changed and more intensive animal feeding and farming practices (waltner-toews and lang ). the emergence of nipah virus may also have been related to bats fleeing from the intense drought and el niñ o-related fires in indonesia (epstein and others, ) . the long list of other infectious diseases related to ecosystem change (patz and others, ) includes schistosomiasis (li and others, ) , cholera (pascual and others, ) , and lyme disease (jones and others, ; blockstein ) . in many of these cases, the disease has emerged as a result of increased food-producing capacity of ecosystems-a provisioning ecosystem service-for example, by animal domestication, irrigation, dams, and other intensive farming practices. a tradeoff has been the unforeseen increase in the incidence and prevalence of many of these communicable diseases. some mediated health effects have also led to migration, while others have prevented the colonization of certain areas. for example, malaria has long restricted human settlement in lowland areas, including the terai in nepal, and many parts of equatorial africa. some chronic, noninfectious diseases can also be classified as mediated effects of ecosystem change, including allergies, asthma, and some forms of cancer and chronic lung disease. for example, lung cancer and pulmonary fibrosis have become particularly common in the region around the shrunken aral sea, as pesticide-contaminated dust from this human-made desert is inhaled (o'hara and others ). both long-distance dust transport and more localized air pollution are also related to ecosystem service change and have been linked with a number of diseases, including asthma and atopy (monteil ) . there is also increasing evidence that air pollution, often exacerbated by ecosystem change such as land clearing and fires, may aggravate heart disease (pyne ) . future ecosystem change, such as desertification, leading to a decrease in the ecosystem provisioning service of clean air, could thus alter the epidemiology of these diseases. these diseases are classified as mediated rather than direct because their connection to changed ecosystems is more complex than are direct effects. direct and mediated health effects are analogous to the direct and indirect health effects of climate change. in that classification, direct (adverse) health effects include phenomena such as heat stroke, while indirect effects include changes to certain vector-borne diseases because of altered patterns of temperature, humidity, and rainfall, and other effects secondary to extreme weather and adverse economic effects. it is possible that a novel emerging disease could escape from a remote ecosystem to enter the wider human population, as the plague and hiv probably did. however, at least in the case of hiv, its really major (modulated) impact depended on powerful social cofactors, including severe poverty, social practices and taboos, and poor governance (butler a (butler , b . the ecological factors that underlie the recent sars outbreak remain unclear (enserink and normile ) , but its origin and amplification in a region of china, characterized by extremely dense populations of humans and domesticated animals and by poor public health services (anonymous ) , is consistent with the view that human-dominated ecosystems today harbor more danger to population health than does the ''wild'' (oxford and others ) . a plausible example of this principle could be the widespread transmission of multi-or even omni drug-resistant tuberculosis emerging from a prison (tanne ; dye and others, ) . this scenario would have severe economic implications, especially for aviation and other industries perceived as increasing the probability of disease spread. we also identify a larger-scale, more lagged, and more causally complex adverse consequence of adverse ecosystem change, than either direct or mediated effects, which we call a modulated or tertiary effect (figure ). these effects include episodes of state failure, or of nascent or realized large-scale social and economic collapse. the role of environmental factors in the causation of large-scale conflicts, state failure, and social collapse is controversial (deudney ; gleick ; homer-dixon ; uvin ; cramer ) . we agree that causation for the phenomena is complex, but we assert that reduced ecosystem services and other adverse ecosystem changes are frequently a component of the causal webs that lead to these phenomena (butler and others ) . this may be of increasing significance in the near future as evidence accrues that ecosystems are being changed more frequently and at larger scales. there is compelling evidence that reduced ecosystem services were a causal factor for several large-scale social collapses and catastrophes, from both archeological sources (weiss and bradley ) and more recent history. two ancient cases are the collapse of the ancient mesopotamian and the mayan civilizations, contributed to, respectively, by increased salinity (jacobsen and adams ) and drought (haug and others ) . two more recent examples are the irish famine of the s and the rwandan genocide in . the irish famine was caused by the spread of a potato fungus (wilson ) interacting with a refusal by the british government to supply an effective substitute, such as famine relief (sen , pp - ) . the rwandan genocide also occurred as a result of the interaction of multiple factors, including poor governance, long-standing ethnic hatred, and rapid population growth. the violence was inflicted mainly by a large number of unemployed young men (mesquida and weiner ; potts ) , displaced from a livelihood in farming because of the shortage of fertile arable land, thus losing a key ecosystem service (andré and platteau ; butler- a) . in these examples adverse health effects are likely to be larger than those from mediated effects, although in some cases state failure may be limited to small populations, such as for the people of easter island or the norse in medieval greenland. inevitably, ecosystem service changes that contribute to modulated effects will be embedded in a mosaic of social, economic, and political cofactors. in turn, many of these cofactors are likely to have at least partial ecosystem change-dependent causation. depending on the knowledge, bias, and experience of the observer, the causal role of ecological factors in state failure may sometimes be underestimated, or even totally denied. for example, rotberg ( ) identifies the roots of state failure as based in ethnic, religious, linguistic, or other intercommunal enmity. he argues that state failure is ''man-made, not merely accidental nor-fundamentally-caused geographically, environmentally, or externally.'' we do not claim that reduced ecosystem services or other ecosystem changes that lead to adverse health effects are always a ''fundamental'' factor in state failure, but they are often important and usually identifiable. the enmity that rotberg refers to often arises over the distribution of diminishing per capita ecosystem services. there may be increasing recognition of this. for example, o'reilly and others ( ) concludes, in discussing the potential for further reduction in the ecosystem provisioning service of lake tanganyika, that ''the human implications of such subtle, but progressive, environmental changes are potentially dire in this densely populated region of the world, where large lakes are essential natural resources for regional economies.'' ecosystem services as a significant element in state failure may be underrecognized due to our tendency to discount the future possibility of thresholds or emergence. thresholds refer to sudden, nonlinear changes that result from a small increment and that are not intuitively predictable without prior experience (alley and others ; waldrop ; may ) . emergence refers to the new property that becomes apparent beyond the threshold. modulated and systems failure effects (described below) are emergent phenomena that become apparent when linked socioecological systems pass a threshold, caused by the interaction of numerous social, political, and ecological elements. we also describe an even larger scale phenomenon than state failure, as a result of coalescing, interacting modulated effects. we call this phenomenon ''systems failure.'' the increasing connections that insulate diverse human communities from scarcity also create large-scale vulnerabilities, magnifiable by feedbacks such as collapsed global trade, terrorism, technological breakdown, and radiating failure of institutions and governance. collapse could occur on a regional, continental, or even global scale. it is also possible, however, that a reverse state, ''systems success,'' could occur. large-scale epidemics exacerbated by chronic food insecurity, poor governance, and wide-scale conflict are plausible elements of this pathway. drug-resistant bacteria, in part driven by the excessive use of antibiotics in animal husbandry, could contribute to this, as could the emergence of new viruses. however, we stress that novel infectious agents are unlikely to lead to modulated or systems failure effects without significant cofactors. only modulated and systems failure effects are likely to be of sufficient scale to alter the unfolding of the various ecological and socioeconomic scenarios that are described elsewhere in this issue of ecosystems. cumming and others ( ) and raskin ( , this issue) review several socioecological scenarios that may unfold over this century. although all plausible futures are influenced by the same driving forces, these forces evolve in different ways in the different scenarios. demographic, economic, political, cultural, and social factors -including health -are codependent so that each factor will continually influence other factors. each scenario will influence and be influenced by ecological factors as well. just as in the past, the future world will contain a mixture of familiar and novel situations. scenarios seek to coalesce these myriad possibilities into a limited number of theme futures that have strongly plausible elements. although there are dozens of names for the existing environmental scenarios, most can be categorized into a surprisingly small group of core pathways, as described by cumming and others (this issue) . the names of the four scenarios considered in this article are market forces, reformed market, value change, and higher fences (see table ). it is difficult to succinctly describe these scenarios, but a number of axes can be identified along which they vary. for example, there is a spectrum identifiable between comparative economic deregulation (market forces) to a neo-keynesian model, here called reformed market. another spectrum can be identified between a concerted attempt to protect existing ecosystem services (the ''value change'' scenario) and a laissez faire approach to ecosystems and the nonliving environment, such as climate change (the ''market forces'' scenario). a third spectrum is identifiable between trade deregulation (''reformed market'') and continuing or even increased protectionism (''higher fences''). as well, the trend of global income distribution can be predicted from these scenarios, from a continuing increase (''higher fences'') to a marked decrease (''reformed market'' and ''value change''). the state of health for high-and low-income populations can be predicted, largely consequent to the anticipated change in income for each group. three of these scenarios, as very briefly described, are essentially optimistic, because they all assume an increase in income for high-and low-income populations. however, in the higher-fences world, it is conceivable that incomes will decline for populations that currently have a low income, and the increased global inequality in this scenario could exacerbate tensions between low and income populations. cumming and others ( ) examine the assumptions made about ecosystem resilience in each of four scenarios and find that the outcome of different scenarios is influenced by this resilience. table lists some key terms concerning health for both high-and low-income populations in these four scenarios. it also shows our estimation of the probability of changes in the ''health gap,'' that is, the gap between high-and low-income populations with respect to health. at present, for example, the burden of disease from diarrhea (of which nearly % can be attributed to unsafe water, poor sanitation, and hygiene) is over times higher in the least developed countries than in developed ones. the health gaps between high-and low-income populations have been systematically estimated using a measure called ''disability adjusted life years'' which accounts for total years of life lost because of disease and also for partial years of life lost because of disability (world health report ) . it is likely that in three of the four scenarios the health gap will decrease. this is because three of these scenarios assume gradual socioeconomic convergence between populations that are currently rich and poor. these scenarios postulate continued advances in science, technology, and the dissemination of information and expertise. the response to the sars outbreak illustrates the potential for a coordinated response to events that are perceived as sufficiently threatening. if convergence between rich and poor populations occurs, then coordinated responses to numerous health problems that continue to affect poor populations are likely. advances could improve new vaccines, attention to ''orphan'' diseases, and dis-tribution of the improved seeds and agricultural techniques needed to enhance food security. in these scenarios the health of high-income populations is also likely to improve, though not as rapidly as for low-income populations. in only one scenario -called ''barbarization'' (raskin, this issue) or ''higher fences'' (cumming and others, this issue) -is the health gap likely to increase. in this scenario, poor populations are increasingly ignored by the remaining population. food security of the poor is likely to further diminish, perhaps leading to positive feedbacks as malnutrition impairs cognitive development and further hinders education and the chance of skillful social and political responses. in this scenario the health of high-income populations is unlikely to be ideal: we identify obesity, diabetes, and anxiety as likely to increase, with their negative effects only partially countered by improved medical technology. modulated effects could sabotage even optimistic scenarios. table provides an estimation of the chance of systems failure, depending on assumptions concerning the resilience of ecosystems and the linked socioeconomic system. cumming and others ( ) have defined ecosystem resilience as the capacity to absorb anthropogenic impacts without the loss of essential structure or functions. we suggest that it is meaningful to assume that human populations are characterized by social resilience, which modifies their capacity to effectively deal with stress (carpenter and others ) . from a public health perspective, resilience may be defined as the capacity of society to respond to problems and challenges, over the short and long term, in ways that protect and advance public health, over the short and long term. affluence, education, social cooperation, technological capability, and flexibility are important determinants of the size of social buffers and human resilience. we suggest that systems failure effects are more likely to occur in the market-forces and higher-fences scenarios, because inequality between high-and low-income populations is likely to be the greatest in these scenarios. the most optimistic future for human health is likely to be if both ecological and social systems prove highly resilient. in this case both major ecosystem and social services are likely to be preserved even if ecosystem changes (currently perceived by many as adverse) continue to occur at a high rate. on the other hand, the chance of further modulated or even systems failure effects occurring is increased if ecosystem and social systems prove to be brittle. because the size of ecosystem service buffers is falling and the extent of ecosystem service resilience is uncertain, it is prudent to reduce fur- ther ecosystem damage as rapidly as possible. however, it is also prudent to conduct this in a way that minimizes harm to human health. continuing tradeoffs are likely to be required. for example, improving the health of populations in indonesia may require further clearing of forests to generate more income. but this process cannot be continued indefinitely. on the other hand, excessively strict protection of the surviving ecosystems could reduce the size of the socioeconomic buffer, thus perhaps increasing the longterm risk of a modulated effect. in reality, economic and social forces make an extremely rapid transition to full protection of surviving ecosystems unlikely, but it may be just as risky to delay protection in response to only short-term socioeconomic concerns. the causal relationship between ecosystem service change and impact upon human health remains incompletely understood. we have explored how ecosystem services impact human health and have proposed that adverse ecological changes can interact and feedback with dysfunctional social responses, leading to the development of states that we have termed mediated and systems failure. we have grouped the myriad possible interactions and cascading responses between ecosystem services and public health into four categories, a previously undescribed taxonomy which might help us better comprehend how ecosystem change and human health interact to affect the way the future unfolds. we believe that this is an important conceptual advance that will be useful for understanding the relationship between human health and changes in ecosystem services. continued analysis of cases studies, using both quantitative and qualitative methods, will advance our understanding of these relationships. several regions of the world, characterized by substantial ecological and social stresses, may be useful ''natural laboratories'' for this purpose, including sub-saharan africa, indonesia, and northern india. direct and mediated effects, although they may lead to some important changes to the path of the future, are unlikely to seriously compromise the development of regional or global civilization. despite occasional and localized setbacks, human health is likely to generally improve if future ecosystem changes result only in events such as occasional flooding, periodic disease outbreaks, and episodes of air pollution. on the other hand, modulated and systems failure effects, if they occur, have the power to alter the course of society in significant ways. if negative this will cause substantial harm to human health and well-being, and, by exacerbating poor governance, could also further erode ecosystem services. such events could derail even the most optimistic scenario. however, we do not deny the chance that positive systems effects could emerge, especially if ecosystem and social resilience remain high. current trends toward an increasingly large environmental footprint, further climate change, depletion of fossil fuels, and the erosion of existing ecological and social buffers 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pendulum. needs to settle near the middle and acknowledge the importance of numbers small particles add up to big disease risk global scenarios: background review for the millennium ecosystem assessment rising life expectancy: a global history the new nature of nation-state failure development as freedom changes in life expectancy in russia in the s rapid economic growth and the four ds of disruption, deprivation, disease and death: public health lessons from th-century britain for st-century china? drug resistant tb is spreading worldwide a universal pattern of mortality decline in the g countries world population prospects: the revision. the demographic impact of hiv/aids tragedy in rwanda: the political ecology of conflict global change: the heat on lake tanganyika complexity. the emerging science at the edge of order and chaos a new conceptual base for food and agricultural policy: the emerging model of links between agriculture, food, health, environment and society what drives societal collapse? infectious disease: an ecological perspective world health organization china's forest policy for the st century we thank the millennium ecosystem assessment for providing many opportunities to discuss the main ideas expressed in this article with colleagues. we also thank professor d. crawford-brown and two anonymous reviewers for their comments and suggestions. key: cord- -fmg hdm authors: chia, terkuma; oyeniran, oluwatosin imoleayo title: human health versus human rights: an emerging ethical dilemma arising from coronavirus disease pandemic date: - - journal: ethics med public health doi: . /j.jemep. . sha: doc_id: cord_uid: fmg hdm nan the world is contending to contain the outbreak of coronavirus which has now resulted to , mortalities out of the , confirmed cases in countries, areas or territories as at march , [ ] . pandemics are usually characterized by a sense of panic and uncertainties. even though, global preparedness and emergency procedures have been enacted [ ] , the uncertainties surrounding this pandemic raise considerable questions to their adherence. widespread restrictions of varying degrees have been placed on individuals, groups, communities, cities or even whole regions. these restrictions ab initio are in contradiction to civil and human rights. these measures which are now widely implemented in many regions and countries of the globe have thrown up fresh ethical questions. between human health and human rights, which takes primacy? notwithstanding that ethical considerations are at the core of planning and implementation in such public health emergencies [ ] [ ] [ ] , the adherence to these regulations and guidelines in reality is problematic. abuse of individual's rights is known to occur when ethical principles reasonable support from the general public thereby minimizing unpleasant consequences [ ] . on this basis perhaps, the world health organization (who) advised against travel restrictions in the current coronavirus pandemic [ ] . the who's international health regulations (ihr) stipulates how nations could address the global spread of disease and without interfering with human activities [ ] . however, with no definite treatment or vaccine for covid- treatment, many nations have enforced measures which seem to contravene the who guidelines. the virus which originated from china and was subsequently exported to other countries and territories before local transmission within those communities has occasioned draconian measures. given that humans are the vectors as well as the victims, minimizing human interaction through social distancing, quarantine and isolation is the most appropriate action to take [ ] . the use of these methods though old fashioned [ ] , in dealing with pandemics appear to be the most immediate and feasible solution now. in the sars outbreak, these same measures were useful in curbing the disease [ ] . hence, an increasing number of nations are restricting travels in and out of their territories, cancelling public gatherings, enforcing quarantine and isolation on individuals as well as declaring partial or total lockdown of socio-economic activities. [ ] . it is expected that emergency preparedness will impact on not only human health but civil and human rights as well [ ] . just as ethics are central to emergency preparedness, so is paternalism to emergency response. public health ethics differs from clinical ethics in that it requires giving priority to promoting the common good over protecting individual autonomy [ ] . paternalism involves restrictions on freedom for the sake of protecting or promoting that individual's best interest; giving priority to wider societal implications than individual rights. the right of individuals to health includes protecting and preventing them from contacting diseases. this helps to ensure that long term interests take precedence over short term interests. public health policies, which focus primarily on population-level health outcomes, may therefore subordinate the interests and rights of individuals to the common good [ , ] . going by this, there seem to be an unofficial consensus that human health takes primacy over human rights. it is clear that no amount of planning and preparation can suffice in these circumstances. often, health care systems are overwhelmed in public health emergencies, in decision making, allocation of resources, prioritizing of patients etc. nonetheless, these measures must be justified and fully communicated. public engagement and transparency in decision making are important factors to consider [ ] . provision of information is necessary for effectiveness, cooperation and compliance from the populace [ ] . the implemented measures should be for a limited period and as necessary, in safe and humane manner [ ] . while the need for human survival precedes individual rights, balancing individual rights against the community's public health needs cannot be overlooked. who. international health regulations, wha . , nd edn. geneva: world health organization world health organization. global consultation on addressing ethical issues in pandemic influenza planning: summary of discussions ethical guidelines in pandemic influenza law in the time of cholera: disease, state power and quarantines past and future ethical and legal considerations in mitigating pandemic disease: workshop summary updated who recommendations for international traffic in relation to covid- outbreak legal and public policy interventions to advance the population's health isolation, quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus ( -ncov) outbreak battling st-century scourges with a th century toolbox epidemiology and control of sars in singapore planning for pandemic: a new model for governing public health emergencies who should receive life support during a public health emergency? using ethical principles to improve allocation decisions ann intern med public health ethics: mappingthe terrain public health strategies for pandemic influenza: ethics and the law accountability for reasonableness medical countermeasures for pandemic influenza: ethics and the law allocating scarce resources in a pandemic: ethical and public policy dimensions key: cord- -pm kdqdw authors: kreuder-sonnen, christian title: china vs the who: a behavioural norm conflict in the sars crisis date: - - journal: int aff doi: . /ia/iiz sha: doc_id: cord_uid: pm kdqdw this article studies a conflict over two competing norms in which the actors demonstrated incompatible positions not through arguments, but through actions. during the sars crisis, china and the world health organization (who) entered a norm conflict over the precedence of sovereignty or global health security. both resorted to behavioural, not discursive contestation: while the who practically but not rhetorically challenged the sovereignty norm by acting according to the norm of global health security, china—without openly acknowledging it—contravened the basic principles of global health security by acting according to the overlapping sovereignty norm. why and with what consequences do actors choose to contest norms through actions rather than words? the article accounts for the resort to behavioural contestation by pointing to the strategic advantages it offers for furthering a contentious norm understanding without facing the social costs of making it explicit. it furthermore highlights that behavioural contestation may feed back into and change the odds of discursive contestation as its practical effects provide rhetorical resources to (de-)legitimate one or the other position. the propositions are illustrated in the interactions of china and the who during the sars crisis and the subsequent norm development. this article forms part of the special section of the may issue of international affairs on ‘the dynamics of dissent’, guest-edited by anette stimmer and lea wisken. at the height of the sars crisis in spring , the world health organization (who) and china fought a silent battle over the prevalence of two competing norms in global health governance. on the one hand, the established norm of sovereignty, particularly the principle of non-interference, had structured a regime for dealing with infectious disease outbreaks that provided ground rules of conduct but ascribed decision-making authority to member states alone. it explicitly ruled out foreign or supranational interference. on the other hand, the emerging norm of global health security was built on an understanding of infectious disease outbreaks as international security problems requiring supranational coordination and governance capacity. in effect, it implied the subordination of national economic and political interests to global disease detection and containment efforts. its proponents thus sought a prominent role for the who in taking decisions in response to global health emergencies which would entail interference with state sovereignty. by the time of the sars outbreak, this normative tension was far from being resolved. on the contrary, the two central actors in this episode, the chinese government and the who secretariat, turned it into a manifest norm conflict by demonstrating incompatible positional differences over the relative priority of the two norms. intriguingly, however, neither china nor the who resorted to discursive modes of contestation by justifying their respective positions with reference to normative arguments. almost exclusively, they displayed incompatible normative expectations in the way they put the norms into practice. the who acted as if the norm of global health security had already been widely accepted, supplanting those aspects of the sovereignty norm with which it conflicted. without prior legal or political authorization to do so, the organization took a set of unprecedented measures. most importantly, it issued travel warnings for affected regions, devised emergency recommendations, and put pressure on governments (the chinese in particular) to comply-clearly challenging the non-interference severe acute respiratory syndrome. principle. conversely, china acted in accordance with the sovereignty norm as enshrined in the international health regulations (ihr), which provided that member states retained the right to decide whether or not to communicate disease outbreaks to the who and that all activities by the who were dependent on member-state approval. not only did china conceal vital information on the outbreak and defy the travel warnings, it also obstructed on-the-ground inspections by who teams-clearly challenging the norm of global health security. here, then, was a 'behavioural' norm conflict between china and the who, characterized by non-verbal expressions of positional differences. both actors engaged in behavioural contestation, defined in this special section of international affairs as those instances 'when the actions of relevant actors imply the existence of conflicting understandings of the meaning and/or (relative) importance of a norm'. it is thus not about arguments advanced by the actors involved, but about actions in implementation, or interference with implementation, of a norm that reflect divergences in actors' norm valuation. why did the actors resort to behavioural rather than discursive contestation? and with what consequences? by addressing these questions, this article sheds light on the so far understudied phenomenon of behavioural norm contestation and provides first insights on its use by fundamentally different types of actors, namely states and international organizations (ios). moreover, it adds to the norm contestation literature, whose focus has predominantly been tied to 'within-norm contestation', that is, discursive contestation of a single norm, by analysing forms and effects of contestation 'from outside', that is, over the relative priority of two competing norms. in a nutshell, my argument is that the recourse to behavioural rather than discursive contestation on both sides of the conflict can be explained by the strategic benefits reaped from silent forms of contestation when actors must fear a backlash against an open and direct norm challenge. that is, behavioural contestation makes it possible to give effect to a certain conflictual norm understanding without imposing the need to justify the full range of normative implications of this understanding. to the extent that these implications are likely to be rejected, it can be advantageous to conceal them by merely implicitly contesting a norm through particular actions. the who had to fear that open contestation of the sovereignty norm, which was still deeply entrenched and legally valid, would spur defensive reactions by many states concerned about their autonomy, not only the few directly affected by its actions. china, on the other hand, had to fear that open contestation of the norm of global health security by privileging sovereignty would lay bare its low esteem for the health and survival of people beyond its borders; this could not be expected to resonate well with a global public aware of a global health threat. furthermore, i argue that the outcome of such behavioural norm conflicts is likely to depend on the practical effects of the contentious actions. most behavioural contestation will at some point turn into discursive contestation in order to settle the conflict. i hold that the terms of this settlement should be affected by the material effects of the previous contesting behaviour, as these effects influence the extent of actors' rhetorical capacities in discursive contestation. in other words, the practical effects of behavioural contestation influence the outcome of later episodes of discursive contestation. empirically, the article shows that the who's assertive crisis intervention (by which it undermined/contested the sovereignty norm in practice) was widely appreciated as effective and functionally important. the renewed process of revising the ihr after the sars outbreak allowed the who and other proponents of global health security to more forcefully advance their normative agenda by pointing to the positive effects that would accrue from their norm interpretation. today, the who is the leading authority in preventing and containing the international spread of infectious diseases, meagrely funded, but armed with the competence to declare public health emergencies of international concern (pheics) and to autonomously devise emergency measures to cope with them. this stands in stark contrast to the architecture of global health governance prevailing up until the early s, in which the who had been forced to watch the spread of epidemics as a bystander because it lacked the competence to intervene autonomously and the member states refused to authorize such actions. this section of the article shows, first, that the traditional governance arrangement was built on a very strong sovereignty norm which put final responsibility for combating infectious disease outbreaks in the hands of state governments; and second, that, starting in the s, an alternative norm of global health security emerged which put the timely detection and effective containment of infectious disease outbreaks centre stage and thus allowed for infringements on state sovereignty, strictly defined. the international governance of infectious disease has traditionally been approached as a matter of interstate agreements. from the first international this argument builds on the assumption that the extent to which justificatory arguments have the desired effect of being accepted as valid by the audience is strongly influenced by the social and material context in which they unfold. sanitary conferences in the second half of the nineteenth century, states considered the issue of contagious pathogens as a problem of two sorts. on the one hand, they sought protection from diseases imported from other countries. to that end, they applied defensive measures such as quarantines at borders and ports. on the other hand, they had the shared interest of not disproportionately disrupting cross-border travel and trade by imposing such measures excessively on one another. the first intergovernmental agreements regulating this complex issue thus gave particular prominence to the question of how to strike a balance between these two countervailing interests. overall, the ambition was not to contribute to the general betterment of global health conditions or to find ways to cooperatively tackle transnational health threats. instead, states self-interestedly tried to preserve a right to unilaterally impose restrictions on aliens while promoting freedom of action for their own citizens abroad. international rules hence aimed at restricting rather than enhancing states' protection efforts without interfering in their internal affairs. to cede authority to an international institution was out of the question. this understanding of governing infectious disease, which relies on interstate agreements to reduce the negative side-effects of domestic containment efforts without supranational interference, is what i call the sovereignty norm in global health. while it has been softened over time, the sovereignty norm has largely structured the entire governance architecture in global health, including the function and design of the who. in fact, at least before , the who secretariat's formal and informal authority has met a sharply defined limit in member-state sovereignty. the who's constitution essentially ruled out any interference with members' sovereignty through the supranational organ by premising any type of direct intervention in member states on their explicit request or acceptance. the same principle also applied specifically to the surveillance of and response to infectious disease outbreaks. the ihr, adopted in , set out in concrete form both the member states' and the who's rights and duties in this policy field. the purpose of the ihr was and remains to ensure maximum security against the international spread of diseases while keeping interference with international traffic and trade to a minimum. their basic substantive tenets were threefold. first, states had a duty to notify the who regarding outbreaks on their territory of only three infectious diseases, namely cholera, plague and yellow fever. second, states had the duty to maintain certain public health capabilities at ports and airports, and were permitted to international affairs : , take, but not to exceed, certain health measures against the spread of diseases subject to the regulations, such as disinfection, quarantines and the examination of vaccination certificates. third, the who secretariat was required to gather and process all epidemiological information received by member states and to disseminate the relevant information of international importance to all national health administrations. with the consent of the member states concerned, it could also investigate particularly serious outbreaks of the mentioned diseases, in order to assist governments in organizing an appropriate response. before the sars outbreak in late , then, the field of infectious disease outbreak surveillance and control was governed by a 'westphalian' contractual legal order in which political authority resided solely with sovereign states. the who secretariat was relegated to the role of an observer and service provider. the most important restriction to its function in combating infectious diseases was that member states held an effective veto over whether the who could publicize outbreaks on their territory or not, because the secretariat was only allowed to disseminate information officially received from member states. two problems with this governance architecture built on the sovereignty norm led to mounting criticism. on the one hand, it became more and more obvious that states routinely disregarded their reporting obligations under the ihr for fear of economic losses in trade or tourism. on the other hand, the emergence of two risk factors highlighted the shortcomings of the existing governance system in terms of reach and capacity: (a) rising concerns about so-called 'emerging and re-emerging infectious diseases' (eids) that might bring about unknown and/or multi-resistant transmissible pathogens through microbial mutation or adaptation; and (b) analyses of economic and societal globalization from which it became clear that increased volumes and speed of travel and trade could lead to the global spread of infectious diseases within days. in , the world health assembly (wha), the main decision-making body of the who, officially started a reform process for the ihr in order to render the international community better prepared to meet such health threats. in the course of the revision process, the who secretariat, together with transnational health advocates and a small group of like-minded states, promoted an alternative approach to the governance of infectious disease. its radical difference from the prevailing regime lay in the reorientation towards another primary goal: from minimal interference with travel, trade and sovereignty to prevention, early detection and concerted containment of infectious disease outbreaks. the goal was to establish a norm of global health security which was built on the understanding that communicable diseases were by their very nature not a domestic or bilateral matter but always an issue of international concern. moreover, given the potentially disruptive repercussions of large-scale border-crossing pandemics for the social, economic and eventually also political cohesion of affected societies, the collaborative management of outbreaks was portrayed as critical to national and international security. this important shift in priorities also implied that, for the attainment of the global public good of health security, more international cooperation and also more binding obligations for states were necessary. if global health security was to be the primary political goal, state sovereignty could no longer remain inviolable. in effect, the normative shift would strengthen the who's capacities to act on such public health events to the detriment of member states' discretion. it is here that the norm of global health security intersects and conflicts with the sovereignty norm in global health. by the end of , however, the new norm of global health security was far from established in the sense of prevailing over the sovereignty norm and being legally endorsed. in the ihr revision process, member states were very reluctant to agree on a new framework which could curtail their sovereignty. the latest proposal circulating before the sars outbreak partly reflected compromises that had already been struck, but partly also issues that remained to be negotiated. most importantly, it was agreed that the limitation of ihr coverage to the three designated diseases should be given up in favour of an approach based on general risk indicators that would capture all pheics. also, the who secretariat would be allowed to collect, assess (in consultation with the member states concerned) and disseminate outbreak information from non-state sources. on the other hand, the proposal for revising the ihr remained silent on who would have the final say in determining the existence of a pheic and on how this decision would be reached. the proposed development of an algorithm or decision tree seemed to be geared towards the aim of formalizing and thus preregulating the question. in any case, before sars, the question was far from settled and nothing indicated that the who director-general (dg) should be entrusted with this task. the proposal advocated the development of a list of key measures which could be recommended to states by the who, but provided that the concerned states would choose the appropriate measures together with the organization. this sediment of the unfinished ihr revision process reveals the limited degree to which the emerging norm of global health security had been accepted prior to the sars outbreak: the powers conferred upon the who to deal with infectious disease outbreaks remained extremely limited and-apart from the outbreak information issue-mostly subject to member-state agreement. in november , a coronavirus that had emerged in bats in the chinese province of guangdong crossed the species boundary to humans, causing infectious respiratory illness. this hitherto unknown form of pneumonia was later named severe acute respiratory syndrome (sars). sars eventually spread to areas around the world, infected , people and killed of them. this section of the article analyses the actions of china and the who during the sars crisis as representing a behavioural norm conflict over the relative priority of sovereignty and global health security. its peculiar characteristic is that china never openly challenged the who's authority in matters of global health and the who never openly denied china's sovereignty rights. both portrayed the situation on the ground in a way that allowed them to act in accordance with their preferred norm understanding. as a result, the actions of each party de facto conflicted with the other's norm understanding. first, the who's emergency measures to counter sars, including travel warnings and naming and shaming practices, are described as a form of behavioural contestation of the sovereignty norm. second, i show that china counteracted the implicit norm shift by also behaviourally contesting the emerging norm of global health security through misinformation and obstruction. third, i provide an explanation for this behavioural norm conflict, pointing to the potential negative implications for each actor of discursively challenging the respective norm. only days later, dg gro harlem brundtland decided to issue an emergency travel advisory that for the first time named the spreading disease as 'sars' and listed all the eight regions, including in china, from which the who had so far received reports on suspected cases. it said that 'this syndrome, sars, is now a worldwide health threat' and provided information for passengers and airlines on how to detect and deal with infections. while these technical guidelines were well received by most governments around the world in what was widely perceived as a situation of growing crisis, health ministries in several countries also complained that they had not been consulted prior to the who's ringing the alarm bells. this should be no surprise, given that the dg had autonomously and effectively declared sars a global health emergency-a decision with huge potential consequences for traffic, trade and tourism. most importantly, however, the who not only determined that a global health emergency existed; subsequently, it also adopted emergency measures which clearly deviated from the organization's established practice and legal framework-even exceeding the then current ihr reform proposal. in particular, it issued concrete travel warnings for sarsaffected regions without member-state consent and assumed the role of a 'government assessor and critic', breaking with the foremost rule characterizing the who's prior norm structure, namely the inviolability of state sovereignty. as the who received cumulative information that more and more areas around the world had developed local chains of sars transmission that could be connected to international travel, especially from hong kong, its 'worries on these issues became so severe that it took actions unprecedented in the history of the organization'. on april , the who issued a direct travel warning, recommending passengers with destinations in hong kong and the guangdong province of china to postpone all non-essential travel. while the decision to include the chinese province was related to an official government report indicating a sharp rise in sars cases in the region, the chinese authorities had never consented to guangdong being the subject of a global travel warning. in fact, china publicly rejected the warning as unwarranted and demanded it be ignored. the who stood firm, arguing that its recommendations were based on objective risk assessments. in accordance with this approach, it soon extended the travel warnings to cover additional areas in china (beijing and shanxi province) and also in canada international affairs : , (greater toronto area). in the period from april to july , the who advised against travel to a total of ten areas in canada, china, hong kong and taiwan. while it never openly contested the validity of the sovereignty norm or the legal system underpinning its authority, the who's crisis management activities reflected an understanding of the two norms of sovereignty and global health security according to which the first was declining in importance and the second rising in importance. without verbalizing this understanding, the who acted in accordance with the main ideas and principles of global health security and relegated sovereignty to a subordinate position. it thus represents a prime example of behavioural norm contestation. china was not the only country subject to travel restrictions and other emergency recommendations by the who, but it was the first and most strongly affected. from the beginning, it obstructed the who's efforts to interfere with what it perceived to be its internal affairs. in contrast to canada, for example, which disputed the inclusion of the toronto area in the who's list of affected regions subject to travel restrictions on factual grounds but accepted the organization's authority in principle, china did not recognize the who as competent to require information from chinese authorities and tell them how to manage public health. while this became obvious in the way in which china interacted with the who, the chinese government never openly argued that the organization was violating the sovereignty norm and/or that sovereignty should take precedence over global health security. in january and february , the who's surveillance networks detected more and more online rumours and reports of a mysterious disease outbreak in southern china, and on february the secretariat decided to lodge an official request for information with the chinese government. beijing promptly replied, reporting an outbreak of acute respiratory syndrome in guangdong province but stating that it was under control and declining. notwithstanding this denial of the disease's persistence in china, the who included a region in china in its travel warning of april. on the day immediately after its release, the chinese minister of health publicly ignored the who's travel advisory, urged travellers to visit the province and said that 'a mysterious lung ailment that apparently originated there is now under control'. in the following days and weeks, a game of cat and mouse developed between the who and the chinese authorities. who headquarters and field officers in china repeatedly made official requests for information and offered their assistance to china in combating the sars outbreak. however, chinese officials continually understated the actual progress of the disease on the ground and provided both the who and the public with faulty or ambiguous information. moreover, while who teams were indeed formally admitted to inspect outbreak sites to enable them to gain an appreciation of the situation, in practice they were time and again escorted to peripheral locations and denied access to the very centres of the sars epidemic. this went on for a couple of weeks before the who and its dg started openly criticizing, indeed denouncing, the chinese government for covering up the true extent of the sars outbreak in both the guangdong province and later in beijing. these public rebukes directed critical international attention towards china, which eventually felt compelled to react by pledging cooperation and providing transparent information. even so, over the following months china continued to deviate from this path, prompting who officials to resume their criticism and attempts to influence the beijing regime. in late may, who representatives were even quoted as threatening to withdraw all its assistance from and suspend working with beijing if the government did not ensure full compliance and cooperation with the organization. while china's actions were morally and politically highly questionable, they were in accordance with the established and long-undisputed sovereignty norm. the country was effectively under no legal obligation to report cases of sars, a disease outside the purview of the valid ihr rules, or to accept instructions from the who. it would thus be misleading to treat this as a case of simple non-compliance. indeed, china did not comply with the who's prescriptions. but from the chinese perspective, it was the who which had implemented a radical shift in its principles of interaction with states that represented an affront to china's sovereignty. to be sure, it had already become accepted that the who could gather and disseminate information on any disease potentially posing a global health threat; but there was no obligation on member states to actively report these cases, nor was the who empowered to declare a pheic and take measures it deemed necessary. fidler, sars, pp. - . international affairs : , different normative logics. since china, like the who, did not explicitly state its opposition to the other party's approach, but merely demonstrated it in practice, we may speak of a 'behavioural norm conflict' between the two actors over sovereignty and global health security. why did both the who and china resort to behavioural rather than discursive contestation? at first glance, it might appear puzzling that the two actors refrained from direct contestation at the discursive level. for the who, as for ios more generally, norm promotion and advocacy are usually seen as part of its core business. ios profit from ascriptions of legitimacy which bolster their authority as norm entrepreneurs and, by implication, as norm contesters. still, the who, whose expert authority has long been widely appreciated, counteracted the sovereignty norm to advance global health security only behaviourally. for china, on the other hand, the surprise attaching to the choice of behavioural contestation relates to the high degree of legalization of the sovereignty norm in the ihr. formally speaking, the state had the law on its side and could, in purely legal terms, have rejected the who's interference with its internal affairs much more resolutely. and yet the chinese authorities preferred to uphold a semblance of compliance with the who's emergency recommendations while defying them only in practice. while the immediate causes and contexts of their actions are different for the two parties, i hold that both shared the same incentive for behavioural contestation: namely, the avoidance of the social or political costs to be expected from discursive contestation. to substantiate this claim, i resort to counterfactual analysis, carefully constructing hypothetical accounts of the consequences for the two actors of choosing contestation through words and not actions. while obviously not providing causal process accounts, counterfactuals have a strong bearing on the plausibility of arguments about avoidance and may thus usefully be employed to explain choice between a limited number of options. for the who, the problem with discursive contestation stemmed from the fact that the immediacy of the sars crisis and the perceived necessity to react swiftly and assertively stood in conflict with the tenacious struggle among member states on how to reform the ihr and thus give expression to a normative shift in global health governance. in the reform process, the who itself had been a part of the argumentative interaction, openly promoting the norm of global health security and thus discursively contesting the sovereignty norm. but when the sars outbreak began, the norm was not yet established. if it were not to stand idly by while the sars crisis unfolded, the who would have to take a course of action which was incompatible with the sovereignty norm for all practical purposes. it could choose only between justifying its actions by openly arguing that global health security was more important than state sovereignty and refraining from discursive contestation while still acting according to the norm of global health security. the consequences of the first strategy, that of discursive contestation, would most probably have been a strong political backlash against the who, for three main reasons. first, by justifying its actions contravening the sovereignty norm on the basis of the emergent alternative norm of global health security, the organization would have publicly acknowledged that it was purposefully and consciously violating the norm on which its authority structure as an international organization was built. against the background of the restrictive ihr of which were still in force in , this would have led to questions of legality being asked much more forcefully. second, the who's actions were very specifically geared towards a small number of member states which had to undergo infringements of their sovereignty rights, whereas the majority of states remained untouched but benefited from the constraints imposed on others. their sovereignty thus did not seem at stake. had the who discursively contested the sovereignty norm in global health by arguing that the principle of global health security should take precedence, this would have undermined the sovereignty norm in general and thus exposed all states to potential incursion. in all likelihood, this would have been met with far less approval. third, discursive contestation by the who, coupled with its self-empowerment to declare sars a global health emergency and to devise political measures to contain it, would have added a 'constitutional' dimension to the relationship between the who bureaucracy and the member states. in view of the complicated and periodically stalling ihr revision process, in which member states struggled to strike a balance between their wishes to preserve sovereignty and their wishes to build a functional international regime to confront infectious disease outbreaks, the who's self-empowerment would have appeared as a usurpation of political authority. this would have raised the much more fundamental question of who holds the constituent power to determine the allocation of competencies in global health governance. presumably, the member states, even those favouring the norm of global health security, would have felt the need to set bounds to the who's sphere of competence. in sum, the who had little to gain from direct contestation, but much to fear in terms of negative side-effects arising from how its actions would be perceived by member states and thus their willingness to accept the who's radical move. china, on the other hand, was arguably predominantly occupied by the reputation costs it could incur for discursively contesting the approach of global health security on the basis of the sovereignty norm. amid the globally spreading sars crisis and the public panic which it caused, the country simply found itself in a position from which it was very difficult to make normatively convincing arguments against global health security. china's rhetorical resources were extremely limited when it approached the disease as a domestic issue precluding external interference, whereas denying the extent and severity of the outbreak could in fact have negative consequences for states and societies everywhere. in essence, the chinese handling of sars and its attempt to limit the impact on chinese trade and tourism by playing down its actual extent had to seem purely selfish to international observers-whatever the normative underpinning of the actions. openly justifying this practice as being in accordance with the sovereignty norm would merely have given greater exposure to the behaviour and thus opened the door for international criticism. for china too, then, there was little to expect from discursive contestation except the prospect of condemnation by the international community. taking these factors together, the indirect norm conflict between sovereignty and global health security enacted by china and the who reveals a simple explanation for the resort to behavioural rather than discursive contestation: discursive contestation would have been more 'costly' and unlikely to succeed. in both cases, this relates to potentially contestable/normatively questionable elements in the actors' practices which they tried to cover up in the subtlety of behavioural contestation. reconfiguring global health governance after sars: who prevails? the sars crisis proved to be a catalyst for the ihr revision process, which had stagnated or made only slow progress throughout the preceding decade. the wha established an intergovernmental working group (igwg) to draft a revised version of the ihr. it took just two years to substantially revise the existing regulations and agree on previously contentious issues such as the determination of a pheic. the new ihr were formally adopted by the th wha in may and entered into force in . in many respects, the new ihr legally enshrine the principles of global health security and clearly relegate state sovereignty to a secondary position. most importantly, the revised regulations contain elements of a proper who 'emergency constitution' that allocate special powers within the organization for the case of a global public health emergency. member states are now required to report all disease outbreaks and 'health events' with potential international repercussions to the who, and the organization can also draw on non-state sources international affairs : , to assess threats. the ultimate decision about whether health events constitute a pheic rests with the who dg, who 'shall make the final determination on this matter'. the emergency powers for the who that derive from a pheic declaration are basically twofold. on the one hand, the organization is allowed to share with other states parties and make publicly available the information it has received from state or non-state sources-even if the states concerned decline collaboration with the who. on the other hand, the who may issue temporary recommendations regarding health measures to be implemented by the states experiencing the pheic or by other states parties to prevent or reduce the international spread of disease. of course, the who has not become an all-powerful governor of infectious disease outbreaks and member states have not forfeited their sovereignty entirely. in fact, in order to preserve sovereign prerogatives, member states rejected several more far-reaching proposals by the who that would have increased its authority in compliance monitoring and verification. nevertheless, the new ihr legalize fundamental principles of the norm of global health security at the expense of member state sovereignty. compared to the legal arrangement pertaining before the sars crisis, the reforms represent a seismic shift in the architecture of global health governance that reflects one norm more than the other. why did the who's behavioural contestation of the sovereignty norm lead to a normative shift in global health governance, whereas china's attempt at opposition and preservation of the primacy of sovereignty remained futile? with an exclusive focus on the norms at play, the outcome could again seem puzzling. after all, the sovereignty norm was and still is widely shared and established across policy fields. many states routinely reject proposals for more intrusive supranational authority beyond individual control. this also applied to the ihr revision process. after sars, just as in the years before, states remained reluctant to formally relinquish the final authority over infectious disease outbreak control. and yet, in the end they did. what changed? i argue that the most important explanatory factor was endogenous to the who's behavioural contestation. first, as argued above, the fact that the who resorted to behavioural, not discursive contestation helped international affairs : , tame the counter-reaction by the defenders of the sovereignty norm. second, and more importantly, given that behavioural contestation works at the level of implementation action, it can produce material effects traceable to the contesting actors. depending on the perception of these effects by the relevant audience as broadly positive or negative, they may become independent sources of or obstacles to rhetorical power when it comes to discursive contestation. in a nutshell, the practical effects of behavioural contestation can be expected to influence the odds in subsequent discursive contestation. in the case at hand, the who's emergency measures were widely regarded as highly effective in containing the outbreak. this positive perception reflected on the norm of global health security on which the who had implicitly based its actions. it thus unleashed argumentative resources for the proponents of the norm shift. while several member states tried to defend the sovereignty norm by narrowing the range of the organization's competencies under the new ihr, the positive example set by the supranational intervention for the norm of global health security reduced the power of their counter-move. the post-sars negotiation process was kicked off by a working draft of the new ihr, written by the who secretariat, that was circulated in january . throughout the year, who regional offices convened consultation meetings in which country delegations could formulate comments and recommendations to the igwg, which convened two plenary sessions in november and may . in the process, several member states, including china but also canada, the united states and many african and latin american countries, voiced concern over what they considered excessive sovereignty losses that would ensue if the initial who proposal were adopted. however, the opposition to the far-reaching proposals was minimal in comparison to what it could have been if the who's norm contestation in the sars episode had been discursive and direct, and/or the practical effects of behavioural contestation had been less positive. while the critics were able to impose limits on the who's accrual of authority, all states eventually agreed to grant the dg the power to declare a pheic and decide on the measures to be taken in response. arguably, the sars crisis and its handling by the who had set a cognitive framework in which the emphasis on global health security forestalled a return to the 'westphalian' status quo ante. in line with this reasoning, debates about the revised ihr were dominated by security-related arguments which stressed the risk of eids as showcased by sars, and arguments highlighting the effectiveness of the path taken by the who to confront this risk. the first real experience with a previously unknown infectious disease brought into focus the dangers associated with eids in general and thus international affairs : , fundamentally altered the risk calculations of the actors involved. widespread fears of the next outbreak provided argumentative resources to support the who secretariat's claim that an institutionalization of centralized emergency capacities was necessary. these arguments were given further credibility by the cooccurring spread of the h n avian influenza virus in birds in and , which was considered to pose a severe pandemic risk. overall, recent literature agrees that the sars crisis and the discursive framing of global health in its aftermath represent key steps in a progressive 'securitization' of eids by which such pathogens have come to be considered as potentially existential threats to the international community. in promoting the contours of its revision proposal, then, the who could point to sars as representing the prototypical danger associated with eids that needed strong supranational response mechanisms. it could also invoke its own emergency measures as an example of how to successfully contain an outbreak. having led an unprecedented international campaign to halt a previously unknown disease-a campaign that had achieved its goal of ending human-to-human transmission only a few months after the 'discovery' of the disease-the who was given credit for its exceptional measures as effective tools for the governance of this global health crisis. as kamradt-scott observes, 'in the wake of sars, a wide range of diplomats, policy-makers, health professionals, and academics publicly praised the secretariat for its handling of the event'. one of the most outspoken of these academics was david fidler, who claimed that 'stopping sars "dead in its tracks" less than four months after the appearance of this new virus ... will undoubtedly rank as one of the great success stories in the history of global public health efforts on infectious diseases'. media reports of the who's performance also asserted, for example, that 'humanity had never responded so quickly, cohesively and effectively to a new international disease threat'. in the ihr revision process, and during the regional consultations in particular, members of the who secretariat and representatives of the respective regional offices drew heavily on these argumentative resources to convince member states of the appropriateness of the proposed changes. it appears from the documentation of at least some of the regional consultations that the who had even managed to present the general thrust of this approach as established fact in the 'background information' to the meetings, declaring that 'increasing globalization and the emergence of new diseases such as severe acute respiratory syndrome (sars) have highlighted the importance of establishing a more effective basis for coordinating the world health organization (the hague: nijhoff, ), p. . who constitution, art. (c, d) the ihr ( ) were preceded by the largely similar international sanitary regulations (isr), adopted in . prior to the major reform of , the ihr were amended only slightly in and . my references apply to the latter version sars: governance and the globalization of disease world health organization issues emergency travel advisory managing global health security, p. . 'inside the who as it mobilized to fight battle to control sars dutiful agents, rogue actors, or both? staffing, voting rules, and slack in the who and wto managing global health security update -travel advice-hong kong special administrative region of china update -sars outbreak: who investigation team moves to china, new travel advice announced', press release global risk governance in health disease diplomacy; kamradt-scott, managing global health security the politics of global health governance from international sanitary conventions to global health security: the new international health regulations who decides on the exception? in determining the beginning and end of a state of emergency, the dg shall take into account, as well as the who's 'temporary recommendations', the views of an emergency committee whose members are selected by the dg from the ihr expert roster: ihr ( ), arts - . see also adam kamradt-scott, 'the evolving who: implications for global health security contagion and chaos: disease, ecology, and national security in the era of globalization the rational design of io performance problems: explaining the world health organization's failures during the ebola crisis', paper presented at international studies association annual convention from international sanitary conventions the new international health regulations: an historic development for international law and public health', journal of law negotiating the international health regulations, global health programme working paper no disease diplomacy contagion and chaos biosecurity in the global age: biological weapons, public health, and the rule of law disease diplomacy who intergovernmental working group on the revision of the international health regulations, igwg/ ihr/working paper/ documentation of the two igwg meetings, including summary reports of the preceding regional consultations the rational design of io performance problems negotiating the international health regulations pandemic pending disease diplomacy managing global health security; hanrieder and kreuder-sonnen, 'who decides on the exception global risk governance in health, p. ) calculates, the measures enabling containment of the sars outbreak were even cost-effective, considering the counterfactual costs of inaction and the possibility of the disease becoming endemic managing global health security constitutional outlines sars exposed world's weak spots; experts welcome hotline for public health emergencies, new powers for who international affairs : , the response to international threats to human health'. moreover, the who sent senior staff members to the meetings in order to explain the proposed ihr revisions. as exemplified in a statement by dr max hardiman, project leader in the who communicable disease surveillance unit, their approach was to take sars as a prototypical example of a global health threat that would necessarily recur. in his address to the western pacific consultation group, he explained that the revision process was driven by 'the need to respond in a responsible, effective, and credible way to the sudden development of public health events that threaten to spread, as illustrated by the sars experience. further serious and unusual disease events are inevitable.' at the same meeting, dr shigeru omi, who regional director for the western pacific, similarly linked the case of sars to the broader problem of emerging health threats in order to argue for the ihr revisions: 'many of you have been on the front line in the fight against severe acute respiratory syndrome (sars), avian influenza and other emerging infectious diseases. but from these threats also come opportunities. the revision of the international health regulations is such an opportunity.' in the end, this argumentative strategy prevailed to the extent that it achieved an 'absolute common sense of purpose' among the negotiators. 'it was exceptional that governments on this occasion, agreed on the nature of the threat and the nature of the solution.' the sars crisis activated a previously latent norm conflict over the prevalence of rules relating to sovereignty and global health security. with china and the who in leading roles, this conflict remained largely behavioural, with both parties refraining from discursive contestation. instead, they silently expressed their understanding of the relative importance of the two norms through implementation actions. this article has set out to uncover the reasons why these actors opted for behavioural contestation and to understand the feedback effects of this choice on discursive contestation.as this article has shown, the resort to behavioural rather than discursive norm contestation is attributable to the expected social and political costs of openly contesting the norms at issue. behavioural contestation makes it possible to conceal problematic or unpopular implications of the preferred norm understanding that are likely to arouse resistance. actors that 'have something to hide' may thus prefer who regional office for south-east asia, second regional consultation on the proposed revised international health regulations, new delhi, india, june- july , project icp csr , p. . the summary reports of the regional consultation meetings on the ihr revision differ widely in the amount of information provided. while some give a narrative summary of the whole consultation process as well as the verbatim records of selected introductory statements, others merely submitted a few unstructured bullet points. the reports can be found at http://www.who.int/ihr/revisionprocess/commentsregions/en/. contestation by way of implementation action as it delivers them from justifying all the normative implications of their position. china could have openly insisted on the predominance of the non-interference principle over global disease detection and containment efforts, because that was the state of the law. but in doing so it would have had to confront the normative question of why its sovereignty rights were more important than the lives of (a potentially high number of ) people around the world-a question it preferred to avoid. the who could have argued that the goal of mitigating a risk to global health security should trump states' sovereignty rights, justifying the infringement of the principle of non-interference represented by its assertive intervention. yet this would have prompted questions about the legality of its actions and exposed the challenge to the sovereignty norm for all states, not just the ones affected by its actions in this case. by opting for behavioural contestation, the who could avoid that expected backlash.the second claim of the article was that the longer-term consequences of behavioural norm contestation are a function of the practical effects produced by the contentious implementation action. as norm contestation makes the transition (back) from behavioural to discursive forms, the material effects of the contestants' behaviour and their valuation by relevant audiences influence the argumentative resources available to actors. that is, practical effects of behavioural contestation (de)legitimate the norm underlying the contentious behaviour and thus feed back into subsequent episodes of discursive contestation. in the present context, the case-study revealed how the perceived problem-solving effectiveness of the who's intervention-by which it behaviourally contested the sovereignty norm-provided an argumentative resource in discursively contesting the sovereignty norm in the subsequent ihr revision process. this resource proved decisive for the settlement of the norm conflict in favour of global health security.overall, the article testifies to the analytical value of studying forms of norm contestation that rely not on words but on actions. not only does behavioural contestation provide actors with an alternative avenue for expressing a certain norm understanding or a certain understanding of the relationship of two or more norms, it also has distinct effects on norm development. linking actions to arguments, behavioural contestation influences the social and material context in which discursive contestation plays out. future research should enquire further into the conditions under which behavioural contestation eventually leads to progressive norm change or to norm decay. stimmer and wisken, 'the dynamics of dissent'. see also sandholz, 'dynamics of international norm change'. key: cord- -f lr lwj authors: nan title: plans and prospects for the s: beyond peak health? date: - - journal: plos med doi: . /journal.pmed. sha: doc_id: cord_uid: f lr lwj the plos medicine editors discuss prospects for health and development in the coming decade. needs to take place, by whom and even, remarkably, when. how can the doctrine of economic growth, on which many of the tangible and psychological elements of societies depend, be reconciled with the accompanying destructive environmental hazards? the times of global consensus and compromise embodied in the paris climate agreement of , seeking to limit the increases in global temperatures and hence their adverse effects [ ] , have given way to a period of uncertainty and disunity-an era of "me" rather than "we". recall "peak oil", the notion that oil production-yielding fuels essential for most forms of transportation to this day, and with many other apparently indispensable industrial useswould reach a maximum and thereafter decline owing to diminishing success in exploration [ ] . although it seems that a global peak has not yet, and may never be, reached, one can imagine that the consequences of progressive oil scarcity could be dramatic, leading to challenging readjustments of societies and economies to develop alternative sources of energy and reduce reliance on environmentally damaging fuels. today, it seems ludicrous that warnings of a possible peak of oil production in the late th century did not stimulate research and the development of large-scale alternatives alongside the quest for more oilfields. despite the positive vision embodied by the sdgs, could "peak health" have already been reached? although the analogy with peak oil may be debatable, there are signs that life expectancy in the united states and united kingdom has reached a plateau, and may be declining [ ] . health inequalities abound. it is anticipated that improved disease prevention and health provision in developing countries will continue to deliver improvements in life expectancy and reductions in life-years lost to disability and ill health but, in all countries, new health challenges will undoubtedly emerge. we must hope that progress in population health does not slip into reverse gear in the coming decades, driven by factors that could include the transition to non-communicable diseases, vaccine hesitancy, environmental stressors, and anticipated but unpredictable hazards such as antimicrobial resistance. when today's leaders return to the paradigm of consensus from that of confrontation, high on their to-do lists should be to work together to find an area of convergence between economic progress, environmental stabilization and continued improvement in human health and wellbeing, all of which can be assessed with meaningful indicators. must we wait until the gains in health made over recent decades are lost? sustainable development goals: decade of action end tb strategy: global strategy and targets for tuberculosis prevention hepatitis: combating hepatitis b and c to reach elimination by world health organization. urgent health challenges for the next decade growing at a slower pace, world population is expected to reach . billion in and could peak at nearly billion around united nations climate change. the paris agreement nuclear energy and the fossil fuels recent trends in life expectancy across high income countries: retrospective observational study key: cord- -hahqwt x authors: alwan, ala title: responding to priority health challenges in the arab world date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: hahqwt x nan the arab world today faces major challenges to health development, which are captured by papers in this series. after my election as who regional director for the eastern mediterranean in january, , my fi rst task was to work closely with who member states to agree on an agenda to address these challenges. a series of high-level consultations was held with countries and experts, after a process of objective analysis of the health situation in the countries of the region. it is a region of great diversity. although many countries, both arab and non-arab, have made great gains and have built extensive modern networks of health infrastructure with wide deployment of medical technologies, these gains have not been shared across and within countries. many of the challenges cut across the health sector and are shared by all countries. in october, , health ministers of the region agreed on fi ve key priority areas-highly relevant to all countries-and on strategic directions for public health action to tackle them. , the priority areas were aligned with the fi ve categories for priority setting that were endorsed by all who member states during the world health assembly in may, . although these directions were intended to guide the work of who, their focus and nature make them applicable for a much broader range of stakeholders and partners. one of the fi ve priorities is strengthening of health systems. accelerating progress towards universal health coverage by reforming health systems is top priority for who in the region. the aim is to ensure access for all people to quality health services without risk of fi nancial hardship. this is a diffi cult challenge considering the current low levels of prepayment schemes and high out-of-pocket health expenditures in many countries. with support from who, and working closely with the world bank and other partners, countries are beginning to develop a vision, responding to priority health challenges in the arab world i owe special thanks to a large network of arab scientists who have contributed to this series. special thanks go to huda zurayk, rita giacaman, samer jabbour, and iman nuwayhid for their persistent and exceptional commitment to this project. thanks also to idrc for fi nancial support, and to the faculty of health sciences at the american university of beirut for hosting our planning and peer review meetings. evidence-based strategies, and road maps to move toward universal health coverage. some countries have started to plan comprehensive reforms, including in health fi nancing, adopting a multisectoral approach. another priority is the unfi nished agenda of communicable diseases. despite commendable progress in past decades in reducing the burden of these diseases, important challenges remain and new ones continue to emerge. the coverage and quality of immunisation programmes vary. viral hepatitis and malaria are major health problems in some countries. the region has the fastest rate of increase among who regions in the number of hiv infections and the lowest coverage with antiretroviral therapy. it also has two of the world's three remaining pockets of polio. recent outbreaks in countries that had been free of polio for many years represent a major impediment to global eradication eff orts, and led ministers of health to declare polio a regional emergency and mount a comprehensive response. new infections, such as the middle east respiratory syndrome, also continue to emerge. although the international health regulations provide a framework for countries to respond to acute public health threats, countries need to do more to meet the requirements set by the world health assembly for achieving the core capacities for surveillance and response by june, , at the latest. a third priority is maternal and child health; chil dren younger than years and mothers needlessly die each year in the region from avoidable causes. at the present rate of action, the region as a whole will not be able to achieve millennium development goals and . a regional response, the dubai declaration for saving the lives of mothers and children, has been launched, and national acceleration plans are being implemented in high-burden countries, which include seven arab countries. non-communicable diseases are also a crucial challenge, particularly cardiovascular diseases, cancers, and diabetes-the burden of each continues to escalate. in some countries, up to % of those dying from noncommunicable diseases are aged younger than years. the response of countries to the very clear road map for addressing non-communicable diseases outlined in the global strategy and the political declaration of the united nations general assembly of september, , is, so far, inadequate. however, countries have adopted a regional framework for action specifying commitments to implement strategic interventions in governance, prevention of risk factors, surveillance, and health care. some progress is being made but gaps in action remain. the fi fth priority is emergency preparedness and response. protracted emergencies seem almost to have become a way of life in some parts of the region, and more than half of the countries are currently facing either acute or chronic crises. the major source of emergencies is civil unrest and violent confl ict. the consequences are clear in the expanding humanitarian crisis in syria and its neighbours, with rising numbers of people displaced. health systems in all countries aff ected are facing major diffi culties in coping with the demands. collective action and solidarity are needed to deliver health services to refugees and host communities, and to increase the resilience of countries to emergencies and ensure eff ective public health responses during crises. much work is still ahead of us in each of these fi ve areas. health goals in the arab world will only be realised through the building of strong health systems, solid commitment to health promotion, and ensuring that health is con sidered in all government policies. solidarity among countries is of crucial importance. the contribution of high-income countries in the region to achieve better health in low-income countries needs to be scaled up. world health organization, regional offi ce for the eastern mediterranean, nasr city, cairo , egypt alwana@who.int i declare that i have no confl icts of interest. the calls for freedom, social justice, and human dignity that resonate within the arab world have been heard loud and clear but, as yet, are not refl ected in a new development paradigm. the legitimate aspirations of the arab population are suff ocated by deeply polarised societies and a very narrow interpretation of social justice. these two deterrents are a manifestation of failure of the development trajectory to embrace fairness and inclusiveness as core prerequisites for individual and social wellbeing. development has emphasised economic growth and access to services, and employed a narrow translation of social justice in terms of provision of minimum basic needs to the poorest populations. as a result, many arab countries (eg, those of the persian gulf, libya, lebanon, algeria, and tunisia) have been placed in very high or high ranks in terms of the human development index. other arab countries, including those in the low human development index rank, have managed to achieve great improvements on economic and health fronts. notably, before the uprisings in tunisia and egypt, these countries were complimenting themselves on such economic and health improvements and on commitments to poverty reduction. , so where did the arab world go wrong? the people of the region provided the answer to this question. protesters on the streets of cairo, egypt, and in tunisia were asking for fair employment, and recognising that jobs and rewards are off ered on the basis of family connections and political affi liations. young women were making their voices heard by objecting to the continuous assault on their public spaces. lowincome and underserved communities were asking for their just entitlements. they all demanded freedom of expression, political voice, and protection from police brutality. they recognised social justice as fairness in the creation of participatory opportunities, and in empowerment not restricted to remedial welfare handouts. clearly, past failures underlie frustrations with the status quo, and have eroded social fabrics and bred extremism and polarisation in society. overall economic growth, which is equitably distributed, and accessibility to public services are necessary but not suffi cient to bring about social changes that can lead to refutation of ideas such as superiority of one religious group over another, or tolerance to discrimination by sex. arab countries must ensure the foundations of citizenry and non-discrimination by sex, religion, and ethnic or social background. i propose that targeting health equity as a central development goal and as a measure of societal success can go a long way in avoiding the failures of the past. health equity needs to capture people's aspirations for wellbeing, and must be grounded in a transformative understanding of social justice on the basis of fairness and inclusiveness for all. this proposal is in full accordance with the global development discourse. it draws on a rich evidence base linking systematic inequalities in health to their structural causes. such a foundation is, at present, evolving into a growing movement pushing health equity to the forefront. this movement is explicit in crystallising the key diff erences between a social determinants approach to health and a social justice approach to health equity. the social justice approach is not about the size of resources, but their fair allocation and distribution, and contributes an additional value judgment to health equity. it considers health inequality as unfair, not only because it involves denial of a human right, but also because it expresses the inequitable distribution of power, money, and resources. the discourse has now moved from eff ective government into good governance. another distinctive feature of the present health equity movement is its concern with wellbeing and not health equity in the arab world: the future we want the state of health in the arab world, - : an analysis of the burden of diseases, injuries, and risk factors public health in the arab world governance and health in the arab world non-communicable diseases in the arab world the path towards universal health coverage in the arab uprising countries tunisia changing therapeutic geographies of the iraqi and syrian wars health and ecological sustainability in the arab world: a matter of survival health and contemporary change in the arab world importance of research networks: the reproductive health working group, arab world and turkey state formation and underdevelopment in the arab world responding to priority health challenges in the arab world health equity in the arab world: the future we want research and activism for tobacco control in the arab world the making of the lancet series on health in the arab world global action plan for the prevention and control of noncommunicable diseases political declaration of the high-level meeting of the general assembly on the prevention and control of non-communicable diseases the political declaration of the united nations general assembly on the prevention and control of non-communicable diseases: commitments of member states and the way forward. resolution adopted at the fifty-ninth session key: cord- -agvg f authors: schröder-bäck, p.; sass, h.-m.; brand, h.; winter, s. f. title: ethische aspekte eines influenzapandemiemanagements und schlussfolgerungen für die gesundheitspolitik: ein Überblick date: - - journal: bundesgesundheitsblatt gesundheitsforschung gesundheitsschutz doi: . /s - - - sha: doc_id: cord_uid: agvg f infectious diseases are among the major global health threats. although associated with these diseases there are vast ethical challenges, ethics has more focused on other health related issues – e.g. associated with rare diseases, embryo research, genetic diagnosis. nowadays we are facing a possible influenza pandemic caused by a new human influenza virus subtype. this article presents issues and ethical challenges of the pandemic threat. the authors argue that it is necessary to consider ethical implications of pandemic influenza preparedness early on and to include ethical reasoning when deciding on the measures for the pandemic management. bi sher behandelt die literatur, die sich mit gesundheitlichen herausforderungen auseinandersetzt und aus bioethik-fachzirkeln kommt, kaum infektionskrankheiten, sondern eher themen wie embryonenforschung oder gendiagnostik. auf der anderen seite hat sich public health, wenngleich intensiv mit infektionskrankheiten, so doch bisher wenig mit ethik auseinandergesetzt. dies ist erstaunlich, da die fülle an ethischen herausforderungen im kontext von bevölkerungsgesundheit und infektionskrankheiten sehr groß ist. immerhin sind infektionskrankheiten oft verhinder-oder behandelbar und töten doch jährlich millionen menschen [ ] . in der bioethik beschränken sich die diskussionen über infektionskrankheiten auf die mikroebene -wie beispielsweise auf fragen zur behandlungspflicht von Ärzten gegenüber infizierten patienten [ ] . aus der perspektive der bevölkerungsgesundheit sind dies eher probleme von individualbeziehungen, die in der bioethik jedoch verhältnismäßig intensiv diskutiert werden. das bewusstsein, infektionskrankheiten und bevölkerungsgesundheit auch aus sozialethischer perspektive zu behandeln, entwickelt sich erst seit wenigen jahren. war sars plötzlich ein thema für die Öffentlichkeit und eine weltweite herausforderung, auch in ethischer hinsicht. der mögliche ausbruch einer pandemie mit einem neuartigen influenza-a-virus (im folgenden kurz: influenzapandemie) beschäftigt public health, die Öffentlichkeit und auch die politik in den letzten jahren vermehrt. eine gute vorbereitung auf eine pandemie beruht jedoch nicht nur auf einer guten epidemiologischen oder naturwissenschaftlichen basis [ , ] . auch ethische aspekte spielen eine rolle, um humane regelungen und maßnahmen zur bewältigung einer pandemie zu entwickeln. der ehemalige who-direktor für ethik, alex capron, sieht die diskussion ethischer aspekte sogar im herzen politischer entscheidungsprozesse zur pandemiemanagementvorbereitung. ethiker helfen, wertkonflikte aufzudecken, und haben zudem die aufgabe, ethische Überlegungen in die politischen entscheidungsprozesse einzubringen. für capron müssen ethiker vor allem darauf drängen, eine gesundheitspolitische planung transparent zu betreiben und in die bevölkerung zu kommunizieren [ ] . dies korrespondiert auch mit den ethischen leitsätzen der us-amerikanischen centers for disease control and prevention (cdc) [ ] . so kann das vertrauen der bevölkerung erreicht werden, und sie wird partner von politik und verwaltung. der operative wert einer solchen planung liegt darin, dass eine informierte, vertrauende bevölkerung im krisenfall besser mitwirken und mehr compliance zeigen wird als eine, die dem staat aufgrund fehlender informationen misstraut und jede anweisung als handlung gegen die bürger verstehen will. wie wichtig es ist, ethische aspekte in diesem kontext zu berücksichtigen, betonen auch thompson et al [ ] . sie zeigen an der erfahrung ihrer heimatstadt to ronto, welche probleme es im zusammenhang mit dem sars-ausbruch gab, bei dem es im vorfeld keine öffentlichen ethischen diskussionen zum krisenmanagement gegeben hatte. sie beschreiben als folge einen verlust des öffentlichen vertrauens, ein niedriges verantwortungsbewusstsein der krankenhausmitarbeiter, konfusionen über zuständigkeiten bei den beteiligten und eine stigmatisierung vulnerabler gruppen. thompson et al. heben hervor, dass durch eine orientierung an ethischen leitgesichtspunkten einige unnötige kollateralschäden hätten vermieden werden können. mit anderen worten: eine pandemievorbereitung, die ethische aspekte nicht ausreichend berücksichtigt, könnte im ernstfall folgenschwere auswirkungen haben. eine pandemie könnte dann nicht nur in einer moralisch-menschlichen, sondern auch in einer gesundheitlichen katastrophe enden [ ] . ziel dieses aufsatzes ist es, auf die zentralen ethischen herausforderungen hinzuweisen, die im rahmen eines influenzapandemiemanagements zu beachten und zu diskutieren sind. es ist unsere grundlegende these, dass eine frühzeitige erörterung dieser herausforderungen das pandemiemanagement verbessern kann. nur eine frühzeitige adressierung der ethischen und gesundheitspolitischen dilemmata und ihrer möglichen lösungswege bedingt gerechtfertigtes vertrauen der bevölkerung in das management einer krise. angesichts der bedrohung durch eine mögliche influenzapandemie wurden pläne zur vorbereitung und zum management einer solchen erstellt. sie sollen sicherstellen, dass im pandemiefall die gesundheitlichen schäden der bevölkerung gering gehalten werden und das öffentliche leben so weit wie möglich aufrechterhalten wird, sodass nach einer pandemie eine schnelle rückkehr in den geordneten alltag möglich wird. entsprechende pläne gibt es auf kommunaler, regionaler und nationaler ebene sowie auch für einzelne krankenhäuser [ ] . eine effektive und ethisch akzeptable vorbereitung und durchführung eines pandemiemanagements ist eine große herausforderung. diese herausforderung potenziert sich, wenn man eine globale verantwor-tung zugrunde legt, die sich einerseits aus dem moralischen hilfsgebot in anbetracht der menschlichen würde aller personen herleitet und andererseits auch einen instrumentellen wert darin sieht, eine pandemie schnellstmöglich weltweit einzudämmen. durch eine schnelle globale eindämmung werden in positiver rückkopplung auch der eigene schaden gering gehalten sowie die infrastrukturmaßnahmen in entwicklungsländern nicht noch weiter zurückgeworfen. derzeit wird diskutiert, welche ethischen leitgesichtspunkte bei der pandemievorbereitung und dem pandemiemanagement als orientierung dienen können [ ] . plausibel erscheint, dass man mit einem patientenzentrierten medizinethischen hippokratischen ethos oder den bioethischen prinzipien (autonomy, beneficence, nonmaleficence, justice [ ] ) kein hinreichendes ethisches instrumentarium zur verfügung hat [ ] . singer et al. geben alternativ ethische leitgesichtspunkte an. sie schöpfen ihre empfehlung aus den diskussionen, die dem sars-ausbruch in toronto folgten. diese leitgesichtspunkte sind: "individual liberty, protection of the public from harm, poportionality, reciprocity, transparency, privacy, protection of communities from undue stigmatisation, duty to provide care, equity, solidarity" [ ] . auch von anderen autoren kommen vorschläge zur normen-und werteorientierung. schröder-bäck fokussiert auf die prinzipien "menschenwürde, gerechtigkeit, effizienz, gesundheitliche gesamtnutzenmaximierung und verhältnismäßigkeit" [ ] . sass betrachtet die berücksichtigung der leitgesichtspunkte "sicherheit, erziehung, minimax, partnerschaft, effizienz und review" als essenzielle orientierungsmöglichkeiten im zusammenhang mit public health, notstand und ethik [ ] . einige der hier angesprochenen ethischen probleme sollen im folgenden intensiver vorgestellt werden. [ ] . die ethischen herausforderungen bei einer influenzapandemie liegen also vor allem darin, dass mögliche public-health-maßnahmen zum schutz der bevölkerung individuelle freiheiten einschränken können [ ] . zu diesen maßnahmen gehören: offenlegung der erkrankung des einzelnen zwecks surveillance und monitoring gegenüber gesundheitsbehörden und sozialem umfeld bis hin zu zwangsuntersuchungen, impfungen und therapie (ggf. gegen den patientenwillen), isolierung, quarantäne, beschränkung der bewegungs-, versammlungs-und reisefreiheit [ ] . hinzu kommen bei einer influenzapandemie ggf. noch verteilungsprobleme -z. b. von knappen medikamenten, vakzinen, krankenhausbetten oder beatmungsgeräten. verteilungsproblemen ist insbesondere zu beginn einer pandemie zu begegnen, weil in ihren ersten - monaten keine bevölkerungsweite impfung gegen ein neuartiges influenza-a-virus möglich wäre, da ein impfstoff erst nach ausbruch der pandemie entwickelt werden kann, wenn der erreger bekannt ist. gerade für diese Übergangszeit ist die versorgung der bevölkerung mit speziellen antiviralen medikamenten (derzeit werden vor allem die sogenannten neuraminidaseinhibitoren als geeignet angesehen) von großer bedeutung. darüber hinaus kann symptomatisch mit anderen grippemedikamenten, antibiotika, schmerz-, und -beispielsweise bei gegebener situation -auch mit palliativmedikamenten behandelt werden, sodassneben einer bevorratung, verfügbarkeit und bereitstellung von neuraminidaseinhibitoren, atemschutzmasken etc. -auch diese mittel in den vorsorglichen plänen der verteilung und zuweisung berücksichtigt werden müssen. außer um organisatorische und finanzielle aspekte geht es also insbesondere darum, nach welchen kriterien die begrenzt, d. h. nicht für alle unmittelbar und sofort verfügbaren güter zu verteilen sind. die verteilung knapper ressourcen erfolgt (beispielsweise innerhalb von regionen ohne hinreichende bevorratung)sofern sie nicht willkürlich sein soll -auf der basis von prioritätensetzungen, die faktisch harten rationierungen gleichkommen können. für harte rationierung "müssen die kriterien klar und transparent sein und die grenzen scharf gezogen werden. spielraum für individuelle interpretationen darf es dann kaum noch geben" [ ] . priorisierungsschemata müssen auf moralisch robusten fundamenten -dazu kann man kontextsensitive spezifikationen und abwägungen der prinzipien menschenwürde und gerechtigkeit zählen -stehen und transparent sein [ ] . sie müssen vor eintritt der krise bekannt sein, von der Öffentlichkeit mitgetragen werden und antizipativ sowie rekonstruk-zusammenfassung · abstract pandemic threat. the authors argue that it is necessary to consider ethical implications of pandemic influenza preparedness early on and to include ethical reasoning when deciding on the measures for the pandemic management. keywords influenza · pandemic · ethics · rationing · justice · trust bundesgesundheitsbl -gesundheitsforsch -gesundheitsschutz · : - doi . /s - - - © sprin ger me di zin ver lag zu sam men fas sung infektionskrankheiten gehören weltweit zu den größten gesundheitlichen bedrohungen. trotz der daraus auch resultierenden ethischen herausforderungen sind entsprechende diskussionen bisher eher im zusammenhang mit speziellen gesundheitsassoziierten themen geführt worden -z. b. zu seltenen krankheiten, embryonenforschung und gendiagnostik. nun droht aber die möglichkeit einer influenzapandemie in absehbarer zeit. im vorliegenden beitrag werden diese bedrohung und die sich daraus ergebenden ethischen herausforderungen diskutiert. die autoren vertreten die these, dass es erforderlich ist, sich frühzeitig, d. h. bereits in der vorbereitung auf eine pandemie, mit den ethischen implikationen einer solchen auseinanderzusetzen und ethisches urteilen bei der weiterentwicklung von maßnahmenkatalogen zu berücksichtigen. influenza · pandemie · ethik · rationierung · gerechtigkeit · vertrauen infectious diseases are among the major global health threats. although associated with these diseases there are vast ethical challenges, ethics has more focused on other health related issues -e.g. associated with rare diseases, embryo research, genetic diagnosis. nowadays we are facing a possible influenza pandemic caused by a new human influenza virus subtype. this article presents issues and ethical challenges of the tiv nach der krise -hier der pandemieethisch vertretbar sein. priorisierung ist kein gegensatz zu leitgesichtspunkten wie "gleichheit" oder "gerechtigkeit", sondern eine situativ bedingte sonderform: wie in einer triage müssen im sinne des allgemeinwohls die primär zu rettenden und zu schützenden personengruppen bestimmt werden. das sollten in diesem fall die in der krise essenziellen leistungserbringer (in einem umfassenden und nicht nur gesundheitlichen sinne) sein [ ] . dazu könntenwas näher zu bestimmen und zu differenzieren wäre -mitarbeiter in strom-und wasserwerken oder im transport-und lebensmittelbereich, sicherheits-und ordnungskräfte, mitarbeiter in krankenhäusern, drogerien, apotheken und auch niedergelassene Ärzte gehören. die verschiedenen von kotalik ausgewerteten pandemiepläne (aus kanada, dem vereinigten königreich (uk), australien und den usa) nennen alle beispielsweise als gruppen mit der höchsten priorität für impfungen die "health care workers". danach kommen die "providers of essen tial services", danach personengruppen mit einem hohem erkrankungs-bzw. Übertragungsrisiko [ ] . eine ähnliche priorisierung muss im ernstfall je nach bevorratungsgrad auch in bezug auf die antiviralen medikamente vorgenommen werden. die kanadischen und us-amerikanischen priorisierungsmodelle sehen vor, hospitalisierten patienten hier die oberste priorität vor kranken "health care workers" einzuräumen, danach kommen "highest risk outpatients" (usa) bzw. "ill high risk persons" in der kommune. beide pläne sehen einen vorrang der therapie vor der prophylaxe. prinzipiell erscheint es durchaus plausibel "health care workers" und "providers of essential services" zuerst zu versorgen bzw. zu impfen. dies geschieht in der absicht, den gesellschaftlichen interessend. h. allen bürgern -gerecht zu werden und mortalität und morbidität zu reduzieren. auch der deutsche nationale pandemieplan -der nicht explizit ethische kriterien, begründungen oder leitgesichtspunkte nennt -sieht vor, dass zuerst das personal im ambulanten und stationären medizinischen versorgungsbereich, dann die berufsgruppen, die der sicherstellung der öffentlichen ordnung und infrastruktur, also der allgemeinheit zuträglich sind, geimpft werden. weitere priorisierungen sollen im pandemiefall auf der basis konkreter epidemiologischer kriterien getroffen werden. dabei geht es dann darum, die allgemeinen komplikations-und mortalitätsraten zu reduzieren [ ] . die beschreibung der moralischen und professionellen rolle, d. h. der rechte und pflichten der Ärzte und -was noch wenig bearbeitet wurde -der apotheker [ ] im pandemiefall ist eine große herausforderung. schon im vorfeld einer befürchteten pandemie sehen sich viele Ärzte mit problemen konfrontiert, wenn patienten sie bitten, vorsorglich privatrezepte für antivirale medikamente auszustellen. diesem wunsch dürfte häufig stattgegeben werden, auch wenn er aus ärztlicher sicht oft von moralischen skrupeln begleitet sein wird [ ] . das handeln des arztes und letztlich auch des apothekers ist in grenzen nachvollziehbar, falls der patientder sein auftraggeber ist und auf dessen wiederkommen er ökonomisch angewiesen ist [ ] -den klaren diesbezüglichen wunsch äußert. die ärztliche expertise und der heilberufliche auftrag reichen allein nicht aus, den herausforderungen im falle einer befürchteten oder auch tatsächlichen pandemie zu begegnen und gesamtgesellschaftliche public-health-probleme zu lösen. hier kann nur eine generelle entlastung des arztes helfen, etwa indem man es ihm zumindest erschwert (beispielsweise über eine indikationsstellungs-bzw. begründungspflicht), spezielle antivirale medikamente privat zu rezeptieren. hier müssen kluge abwägungen getroffen werden, die mit der ärztlichen individualethik und mit sozialethischen ansprüchen vereinbar sind [ ] . eine zentrale gesundheitspolitische frage, die diskutiert werden muss, betrifft die versorgungsverpflichtung von Ärzten und weiterer im gesundheitswesen beschäftigter, sobald sie sich selbst einer erhöhten ansteckungsgefahr aussetzen. wie weit geht die standesverpflichtung des arztes, seinem patienten gutes zu tun? letztlich brauchen die wichtigen und un-verzichtbaren leistungserbringer -vor allem diejenige, die den kranken in der akutversorgung begegnen -ausreichende sicherheiten, damit sie ihre arbeit auch in der akuten krise wahrnehmen und nicht zu hause bleiben [ ] . zudem kann man ihnen anreize oder kompensationen bieten (z. b. spezielle versicherungsfonds, die auch für andere berufsgruppen wie techniker oder bestatter gelten könnten [ ] auf soziale ereignisse und kontakte ("social mixing") muss in fortgeschrittenen pandemiephasen ggf. verzichtet werdend. h. schulen und öffentliche plätze müssen geschlossen werden, öffentliche veranstaltungen sollten nicht mehr stattfinden [ ] . es muss geklärt sein, wer die verantwortung und wer die befugnis hat, solche maßnahmen durchzusetzen und bei verstoß sanktionen zu erlassen und konsequenzen zu ziehen [ ] . isolation und quarantäne sind weitere konzepte zur eindämmung von infektionen. die beiden begriffe werden fälschlicherweise oft als synonym verwendet. die isolation ist eine maßnahme, um infizierte personen zu separieren, die andere personen anstecken können. in der quarantäne schränkt man hingegen den aktionsradius gesunder personen ein, die expositionsverdächtig waren [ ] . die quarantäne kann einzelpersonen oder größere gruppen betreffen. bei influenzapandemien spielen Übertragungen im familiären bereich eine große rolle, was bei der pandemieplanung berücksichtigt werden muss [ ] . besonders brisant wären distanzierungsmaßnahmen in haushalten und familien, weil diese kleinste gesellschaftliche einheit besonders geschützt ist und für sie grundsätzlich das prinzip der staatlichen nichteinmischung gilt. quarantänemaßnahmen können im pandemiefall ein mittel zum gesundheitsschutz der bevölkerung sein. allerdings muss hier deutlich differenziert werden: eine freiwillige quarantäne ist ethisch wenig herausfordernd, eine unfreiwillige wäre anwendung von zwang, der moralisch gerechtfertigt sein muss. eine unfreiwillige quarantäne wäre ethisch eher zu verantworten, wenn für die betroffene personengruppe therapeutika oder impfstoffe zur verfügung ständen. ist dies jedoch nicht der fall, wird die abwägung, eine quarantäne zu treffen, noch schwieriger. um unangemessenen reaktionen bis hin zur panik in einer krisensituation vorzubeugen, ist es sinnvoll, die bevölkerung rechtzeitig, d. h. im vorfeld, aufzuklären. erforderlich ist in diesem zusammenhang die verbreitung umfassender informationen über die krankheit selbst und auch über selbstverständliche hygienemaßnahmen sowie andere schutzmaßnahmen [ ] . folglich sehen der deutsche nationale pandemieplan sowie die entsprechenden pläne von ländern und kommunen auch die verteilung bürgernaher informationen vor [ ] . informationsmaßnahmen verbessern die mitwirkung des bürgers und erfüllen zudem seinen informationsanspruch [ ] . in diesem sinne ist die bereitstellung umfassender gesundheitsinformationen aus ethischer sicht genauso wichtig wie die transparenz bei der pandemiemanagementvorbereitung sowie bei allokationsentscheidungen und den ihnen zugrunde liegenden ethischen kriterien. informationen und transparenz schaffen letztlich begründetes vertrauen [ ] . die usamerikanischen cdc raten dringend zur transparenz, d. h., sie empfehlen, in einer allgemeinverständlichen sprache darzulegen, was die entscheidungskriterien in härtefällen sind. klarheit und offenheit ergibt sich aus dem ethischen gebot der achtung gegenüber individuen [ ] . eine fachlich gute und ethisch akzeptable vorbereitung auf eine pandemie sieht vor, dass pandemiepläne auf die resultierenden herausforderungen realistische und in der kommune, region und nation erprobte handlungsansätze finden. zur erprobung können beispielsweise Übungen, szenariendiskussionen oder simulationen durchgeführt werden. in diesen sollte man, auch aus ethischen gründen, von notstands-und triagesituationen, also von einem worst-case-szenario ausgehen [ ] . denn gerade in diesen situationen können ethisch relevante aspekte und lösungswege am besten diskutiert und entwickelt werden. aufbauend [ ] . das ecdc hat zudem auch den deutschen influenzapandemieplan evaluiert und mit den anderen influenzaplänen aus der eu verglichen [ ] . bisher sind die spezifisch ethischen aktivitäten auf dieser ebene allerdings noch nicht sehr ausgeformt. es könnte aber eine aufgabe der eu und konkret des ecdcs sein, einen europaweiten ethischen diskurs mit anzustoßen. die globalisierung und die damit verbundene mobilität von menschen ermöglicht eine schnelle ausbreitung ansteckender krankheiten. global gesehen, stellt uns die pandemievorbereitung vor einige organisatorische und ethische herausforderungen. zu den organisatorischen zählen z. b. der aufbau funktionierender informations-und meldewege, von netzwerken aus epidemiologen und biologen sowie die erarbeitung von regeln für reisebeschränkungen. im ernstfall müssen reisewarnungen ausgegeben und es muss über ausbrüche in den betreffenden staaten berichtet werden, dies möglichst ohne stigmatisierungen hervorzurufen. zudem muss von behördlicher seite auf die beibehaltung eines schnellen und zuverlässigen kommunikationsflusses geachtet werden. beim sars-ausbruch lag beispielsweise eine große herausforderung darin, dass sich china nicht als ausbruchsland sah. daraus schließen singer et al.: "it is no longer acceptable for countries to hide health information that can protect others. sharing public health in-formation is part of maintaining the global public good of health protection, and should be encouraged and admired." [ ] im bemühen, ethisch akzeptable antworten auf eine weltweite bedrohung durch eine influenzapandemie zu erhalten, stellt sich im weiteren sinne auch die frage, wie einzelne regierungen die pflichten ihrer eigenen bevölkerung gegenüber mit möglichen pflichten gegenüber anderer länder bevölkerungen abwägen [ ] . ein besonderes augenmerk gilt dabei den entwicklungsländern. die bevölkerungen armer staaten haben wesentlich weniger möglichkeiten, gesundheitskompetenzen zu entwickeln, ihre ernährung und die hygieneverhältnisse sind schlechter, und sie haben einen deutlich schlechteren zugang zu impfungen oder zur gesundheitlichen versorgung im krankheitsfall [ ] . prospektive quantitative analysen zeigen, dass entwicklungsländer mit hoher wahrscheinlichkeit die größte bürde einer influenzapandemie zu tragen hätten. murray et al. gehen davon aus, dass in den oecd-ländern aufgrund der vorhandenen symptomatischen behandlungsmöglichkeiten, von impfungen, der verfügbarkeit von antibiotika zur behandlung von sekundärerkrankungen wie lungenentzündungen sowie aufgrund des deutlich besseren gesundheitsstatus der bevölkerung die auswirkungen einer influenzapandemie weniger drastisch wären als in den entwicklungsländern. hinzu kommt, dass diesen eine umfassende vorbereitung auf eine pandemie nicht möglich ist [ ] . eine besondere unterstützung für entwicklungsländer im vorfeld und fall einer pandemie ist nicht nur aus ethischer perspektive von relevanz, sondern auch politisch klug und vorausschauend [ ] , um die eigenen interessen zu schützen (möglichst geringe auswirkungen auf die bevölkerungsgesundheit, die Ökonomie und die globale stabilität). es wäre aber auch zu erörtern, welche ethischen verpflichtungen entwicklungsländer im rahmen ihrer möglichkeiten gegenüber anderen ländern haben. im rahmen der globalen kommunikation sind die "surveillance systeme" zu betrachten -sowohl in internationaler als auch nationaler perspektive, da es auch in deutschland hier noch verbesserungs-potenzial gibt. mckee und atun zufolge kann ein globales surveillancesystem -das in zeiten des h n -influenzavirus dringend benötigt wird, um die vorboten einer pandemie und ihre weitere entwicklung zu beobachten bzw. die bevölkerung schnellstmöglich schützen zu können -nur so gut sein wie das schwächste mitglied dieses systems. eine besondere herausforderung liegt hier -außer in dem möglichen problem, dass staaten einen ausbruch bewusst nicht meldenin den sogenannten nichtstaaten (nonstates), d. h. in rechtlich unsicheren und nicht weithin anerkannten territorien. deren public-health-systeme bzw. fehlende internationale einbindung hemmen den aufbau eines effizienten globalen surveillancesystems. im kaukasus ist beispielsweise eine public-health-surveillance kaum vorhanden, auch ist es international kaum eingebunden. das exportland taiwan besitzt zwar ein gutes system, steht aber politisch isoliert da. in nordzypern und palästina gibt es probleme aufgrund der politischen teilung. zu den nichtstaaten zählen auch transnistrien, der kosovo, abchasien, die republik bergkarabach und westsahara [ ] . es besteht die notwendigkeit, diese schwächen der surveillance im eigenen sicherheitsinteresse in den blick zu nehmen. jenseits des umstandes, dass die versorgung der personen in nichtstaaten im pandemiefall suboptimal wäre, gibt es noch weitere ethisch relevante aspekte. die nichtanerkennung von personen oder auch von personengruppen bzw. von staaten ist ein prinzipielles moralisches problem, da es missachtung ausdrückt [ ] . nichtanerkennung hat immer mit der nichtbeachtung einzelner personen als zweck an sich, als träger von menschenwürde zu tun [ ] . es ist zu diskutieren, ob es unsere moralische pflicht gegen über diesen ländern ist, ihre situation zu verbessern und ihre anerkennung zu fördern. die verbesserung der surveillancesysteme könnte man ggf. als anlass nehmen, sich in diesen ländern vermehrt zu engagieren, um public health -auch in unserem sinne -sowie anerkennungsprozesse voranzutreiben. in bezug auf die pandemieplanung gibt es also einerseits generelle Überlegungen im eigeninteresse eines staates. in diesem zusammenhang wird gefragt: wie koordinieren wir und wie bereiten wir uns vor, sodass uns eine mögliche influenzapandemie so wenig wie möglich (auch nachhaltig) im eigenen land schadet. andererseits gibt es die ethischen leitgesichtspunkte, die dritten gegen über -d. h. gegenüber den entwicklungsländern und nichtstaaten -zur unterstützenden handlung auffordern. die autoren votieren mit diesem beitrag für eine frühzeitige und philosophischsystematische auseinandersetzung der Öffentlichkeit, politik und verwaltung mit den vielfältigen ethischen aspekten eines pandemiemanagements. im folgenden sollen einige initiativen vorgestellt werden, die diesbezügliche diskurse führen und einige der bereits genannten ethischen aspekte reflektieren. im sommer trafen sich in bellagio, italien, wissenschaftler und experten aus der gesundheitspolitik, um über gerechtigkeitsfragen im zusammenhang mit einer pandemischen influenza zu beraten. vertreten waren neben fachleuten aus den bereichen tiergesundheit, Ökonomie, public health und virologie auch ethiker: der gerechtigkeitsphilosoph allen buchanan, der medizinethiker alex capron und die public-health-ethikerin ruth faden. ihre diskussion fokussierte sich speziell auf die situation und auswirkungen einer influenzapandemie auf die entwicklungsländer bzw. allgemein auf benachteiligte personen und populationen [ ] . auf der tagung wurde ein statement verabschiedet, das ethisch relevante forderungen aufstellt, an denen sich sowohl regierungen als auch nichtregierungsorganisationen (ngos) im falle einer pandemie orientieren können. in dem statement, das prinzipien expliziert, wird zunächst gefordert, dass alle -vor allem auch die unterprivilegierten -personen zugang zu qualitativ guten und verständlichen informationen über die pandemie und über maßnahmen zur eindämmung kollektiver und individueller gesundheitsgefahren erhalten [ ] . wörtlich heißt es: "all people should have ready access to accurate, up-to-date and easily understood information about avian and human pandemic influenza, public policy responses, and appropriate local and individual actions. communications should be tailored to overcome obstacles that disadvantaged groups face in accessing such information." [ ] ferner wird gefordert, alle relevanten stakeholdereinschließlich des privaten sektors -in die unterstützung benachteiligter gruppen zu integrieren. des weiteren sollen surveillancesysteme implementiert werden, die eine stigmatisierung oder diskriminierung benachteiligter gruppen ausschließen. entsprechend muss die effektivität von public-health-maßnahmen auch unter dem gerechtigkeitsaspekt gegenüber benachteiligten bewertet werden. das fünfte prinzip fordert, den entwicklungsländern zugang zu den verfügbaren wissenschaftlichen und sozioökonomischen daten zu eröffnen, sodass ihnen eine optimale vorbereitung auf bzw. bekämpfung einer pandemie ermöglicht wird. als letztes wird ein gerechter und gleicher zugang zu vakzinen und anderen medizinischen bzw. public-health-maßnahmen gefordert -sowohl innerhalb eines landes als auch zwischen ländern [ ] . die who hat einen ersten pandemieplan "influenza pandemic preparedness plan" [ ] herausgegeben, der grundlage für viele nationale influenzapandemiepläne war. gegenwärtig wird von der who ein projekt koordiniert, das sich mit den ethischen fragen der pandemievorbereitungen und des pandemiemanagements befasst. zu diesem "project on addressing ethical issues in pandemic influenza planning" existieren derzeit nur arbeitsgruppenpapiere, die als entwürfe kursieren, sowie eine öffentlich zugängliche tagungsdokumentation [ ] . ein offizielles who-dokument mit dem titel "ethical considerations in pandemic influenza planning" befindet sich in der erstellungsphase. die tagungsdokumenta-tion gibt aber schon einblicke in die (vorläufigen) ergebnisse der arbeitsgruppen [ ] . diese werden im folgenden vorgestellt. von der ersten arbeitsgruppe "promoting equitable access to therapeutic and prophylactic measures" wird die bedeutung der grundlegenden prinzipien effizienz, gleichheit und verantwortlichkeit für die erarbeitung von priorisierungsfestlegungen dargestellt. je nach ihrer gewichtung und ausdifferenzierung resultieren verschiedene priorisierungsschemata für die vergabe von medikamenten und impfstoffen. diskutiert wird u. a., impfstoffe gemäß dem effizienzprinzip vor allem denen zu verabreichen, die potenzielle Überträger der viren sind (z. b. personen, die aufgrund ihrer tätigkeit im krankenhaus viel kontakt mit infizierten haben). die who-arbeitsgruppe "isolation, quarantine, border control and social-distancing methods" weist darauf hin, dass alle maßnahmen eines pandemiemanagements bürger-oder sogar menschenrechtsrelevant sein können. so ist es wichtig, einschränkungen von rechten anhand international akzeptierter kriterien vorzunehmen; beispielsweise immer aus den möglichen maßnahmen die am wenigsten restriktiven zu wählen und nicht zu diskriminieren. hier können ansätze der public-health-ethik helfen, in dilemmasituationen die richtigen abwägungen zu treffen. in der arbeitsgruppe "the role and obligations of health-care workers during an outbreak of pandemic influenza" wird erörtert, wie weit die verpflichtungen der beschäftigten im gesundheitsbereich angesichts der potenziellen risiken gehen, denen sie im fall einer pandemie ausgesetzt sind. in der arbeitsgruppe "issues that arise between governments when developing a multilateral response to a potential outbreak of pandemic influenza" werden die verpflichtungen diskutiert, die staaten einander gegenüber haben, um im falle einer pandemie die durchführung konzertierter aktionen zu ermöglichen. auch soll sichergestellt werden, dass einzelne staaten vulnerable minderheiten nicht als verursacher von pandemien darstellen können und diese damit zu "sündenbö-cken" machen, also sie stigmatisieren oder diskriminieren. zusammenfassend kann festgehalten werden, dass die who also gegenwärtig die ethischen aspekte diskutiert, denen sich einzelne staaten in nationaler und globaler perspektive stellen müssen. das von der who angestoßene globale konsultationsverfahren ist ein wichtiger schritt in der bewusstmachung ethischer aspekte der influenzapandemieplanung. es ist wünschenswert, dass diese diskussionen weltweit von gesundheitspolitikern auf allen staatlichen ebenen rechtzeitig wahrgenommen werden. eingangs wurde kritisch gefragt, warum sich die bioethik nicht hinreichend und verhältnismäßig mit den möglichen folgen und konsequenzen der bedrohung durch infektionskrankheiten befasst hat. natürlich kann man ethikern und angewandten ethikdiskursen nicht vorschreiben, welchen forschungsgegenstand sie wählen sollten. es ist unseres erachtens jedoch notwendig, einen eigenen diskurs zu diesen drängenden fragen anzustoßen. ethiker müssen für public-health-fragen sensibilisiert werden, andererseits muss public-health-wissenschaftlern und praktikern die möglichkeit gegeben werden, mit ethikern in einen interdisziplinären dialog einzutreten [ ] . angestoßen durch die sars-ausbrüche und drohende pandemien, ist dies in ersten ansätzen erfolgt, es beginnt sich eine neue bereichsethik, die public-health-ethik, herauszuschälen. dieser beitrag und die weiteren aufsätze des vorliegenden themenhefts des bundesgesundheitsblatts wollen diesen diskurs auch im deutschsprachigen raum fördern, auf seine dringlichkeit aufmerksam machen und erste methodische und inhaltliche anstöße geben. public-health-ethik liefert einen anderen normativen referenzrahmen als bioethik, weil sich letztere eher individualethisch auf arzt-patient-bzw. forscher-proband-verhältnisse bezieht und hier unter der prämisse, patienten-und bürgerrechte zu stärken, entscheidungskri-terienberatung anstrebt. public-health-ethik hat demgegenüber einen anderen auftrag, andere akteure und netzwerke, andere ziele und methoden. sie liefert mit eigenen grundsätzen einen eigenen ethischen rahmen [ , ] . es ist eine gesundheitspolitische aufgabe auch im sinne einer weit voraus gedachten prävention, public-health-ethik zu institutionalisieren (z. b. durch forschung und lehre an den gesundheitswissenschaftlichen fakultäten, eine eigene wissenschaftliche zeitschrift, fachgesellschaften und wissenschaftliche beiräte), um auch im zusammenhang mit drohenden gesundheitlichen gefährdungen von bevölkerungsgruppen ethische gesichtspunkte noch stärker als bisher in public-health-planungen einbeziehen zu können. weltweit bereiten sich regierungen und verwaltungen mit notfallplänen auf mögliche pandemien vor. dabei wird eine systematisch-philosophische auseinandersetzung mit ethischen aspekten allerdings erst in ansätzen praktiziert [ ] . ein differenziertes bewusstsein über die ethischen herausforderungen und probleme im zusammenhang mit dem management von influenzapandemien ist erst im entstehen und bedarf der weiterentwicklung [ ] . in einer aktuellen usamerikanischen analyse wird bemängelt, dass vorbereitungen und pläne zur bekämpfung von pandemien keine "ethische sprache" verwenden [ ] , d. h. moralische dilemmata noch nicht überall hinreichend mittels ethischer methodiken aufgearbeitet wurden. auch in der neufassung des deutschen nationalen pandemieplans ist an keiner stelle das wort "moral/moralisch" oder "ethik/ethisch" erwähnt, wenngleich den fachlichen reflexionen implizit ethische kriterien zugrunde liegen. es ist notwendig, sich im rahmen der influenzapandemievorbereitung frühzeitig und bewusst auch mit den ethischen implikationen einer solchen explizit auseinanderzusetzen und ethisches urteilen bei der weiterentwicklung des maßnahmenkatalogs zu berücksichtigen. diese public-health-ethischen diskurse zielführend voranzutreiben und dabei die in diesem beitrag dargelegten herausforderungen zu adressieren und darauf antworten zu finden ist eine lohnende aufgaben im schnittfeld von gesundheitspolitik und katastrophenvorbeugung. kor re spon die ren der au tor dr ethics and infectious disease duty to treat or right to refuse? pandemic influenza preparedness: an ethical framework to guide decision making ethical guidelines in pandemic influenza -recommendations of the ethics subcommittee of the advisory 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key: cord- -ntv e s authors: han, qide; chen, lincoln; evans, tim; horton, richard title: china and global health date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: ntv e s nan china is the world's oldest continuous civilization. during the past years, the country has emerged as a strong and confi dent global partner. at home, china has experienced unprecedented material improve ments, doubling its gross domestic product per capita, for example, between and . what are the major challenges for the health of the chinese people? what are the implications for global health? the authors of the papers in this special issue of the lancet on china's health system were invited to address these questions as china's global engagement continues to expand in the opening decade of the st century. - the reasons for commissioning this report are compelling. despite accounting for over a fi fth of the world's population, the importance of china to global health has been under-recognised by the international health community. this perception is changing rapidly, especially after the august, , olympics. there are at least four reasons, contemporary and historical, for china's growing role in global health. first, the sheer demographic weight of china's popula tion undergoing rapid and profound health transitions is of enormous global importance. china is a substantial part of virtually all global health challenges: the prevalence of chronic cardiovascular diseases and cancers; re-emergence of infectious threats such as avian infl uenza; nutritional transitions due to changing food, diet, and physical activity; and new environmental and behavioural threats. [ ] [ ] [ ] for each of these health challenges, what happens in china is a major driver in the dynamics of global health. second, china is a major source of health innovationwhether based on its rich traditional pharmacopoeia, its modern cadres of engineers and scientists, or as a source of social experimentation. for example, artemesinin, the most eff ective drug against the malaria parasite, comes from traditional chinese medicine. china's universities and modern research laboratories are increasingly attracting outsourced research and development investments. community health workers that were pioneered in the s and subsequently refashioned as barefoot village doctors are an acknowledged chinese innovation for primary health care. china, like many other countries, is struggling to manage the public-private mix in health care; its new eff orts to address various market failures are likely to contribute signifi cantly to global understanding of what does and does not work. , , third, china is a major contributor in the control and spread of global health risks, an inevitable aspect of china's growing international participation in the trade of goods, services, and people. in other words, what happens in china is important for the health of others around the world. emergence of new infectious diseases, such as severe acute respiratory syndrome, and persistence of old pathogens (eg, tuberculosis) illustrate why china's health situation has global importance. the spread of transnational health risks is an inevitable aspect of china's participation in global transactions, as recently illustrated by controversy surrounding pet foods, cough syrup, and toothpaste. moreover, as china's energy consumption grows, industrial pollution and carbon production will assume growing global health importance. finally, china's customary reserved role in international institutions is changing as the country assumes more global responsibilities, especially in peace and social sectors such as health. although china's health sector is overwhelmingly internally focused, its global reach is expanding, as shown by its assistance to sub-saharan africa, to where china has dispatched more than health teams. china's success in securing the election of the fi rst chinese head of a un agency, who, marked a turning point of china's participation in global health governance. to probe the scope and depth of china in the context of global health, a collaboration between chinese and international health scientists-convened by the peking university health sciences centre, the lancet, and the china medical board-commissioned this report, including papers: seven theme papers and commentaries. - written by authors, of whom two-thirds are chinese, the report brings together diverse scientifi c evidence about china's major health problems, its current strategies, and china's health future. like many other developing countries, china has experienced dramatic demographic and epidemiological transitions. with a population that is mainly urbanised and elderly, china's major health threats are chronic diseases, now accounting for more than three-quarters of all deaths. patterns of injury are also changing. although china has been successful in the control of infections and maternity-related conditions, these health problems have by no means been eliminated, as exemplifi ed by continuing infectious outbreaks, reproductive health problems, and persistent schistosomiasis. evidence underscores the fact that china faces a daunting health future. behavioural shifts cast a long and dark shadow of burdens due to such risk factors as smoking and changes to diet and physical activity that will be accompanied by new infections, environmental threats, and behavioural pathologies. an important signal of china's stronger political commitment to health is shown by the expanding role of the state in health-care provision and stewardship, together with the mobilisation of communities and civil society for health improvement. the results of these changes are already measurable. china is now on track to reach millennium development goal (mdg) , reducing child mortality by two-thirds between and . this achievement has been made through antipoverty policies, land reform, investments in agriculture, and economic growth, as well as through improved health services. china has also made important progress on mdg , the reduction of maternal mortality. health care in china, however, is distinctive in several ways. first, the scale is vast. whatever the problem or solution, china's health conditions are gigantic in size-with more than million smokers, million people with hypertension, and an estimated million urban migrants, stretching demand for new forms of health care. , second, the speed of health change in china has been extremely rapid. health transitions that took nearly a century in other richer countries have taken place in a few decades in china. , third, china's unique national history and ecology have resulted in great diversity in health conditions and responses. many aspects of health in china will demonstrate both commonality and exceptionalism within the country and among nation states. an example is medical ethics and human rights, in which china has been moving towards universal norms while at the same time contributing a unique tradition of chinese philosophy and values. and fourth, china increasingly has the economic capacity to make profound advances in health. china's spectacular economic growth enables it to augment its investments in health substantially. like many countries facing complex health and healthcare challenges, it is all too easy to oversimplify the situation in china, where there are many unanswered puzzles. even as china has witnessed increasing numbers of deaths from transport injury, for example, it has had a striking but largely unexplained decline in suicides; sociocultural dynamics that generate high male but low female smoking rates are inadequately understood; and many clinical medicine graduates do not end up working as doctors. understanding these and other health conundrums deserves prioritisation, facilitated by a review of research needs and eff orts to improve the quality of and access to relevant health information. achieving health equity is china's main health challenge, in view of the well documented problems of incomplete coverage, uneven access, mixed quality, escalating cost, and high risk of catastrophic health expenditures. the chinese government recognises these challenges and has announced the healthy china initiative to reform disease prevention and health promotion, health-care services, pharmaceutical policies, and health insurance. these eff orts are the latest and most ambitious round of health reforms that aim to tackle growing health inequities. , drastic reforms of health fi nancing (more public investment, improved prevention, universal insurance, containment of costs, enhancement of quality, and alignment of incentives) and human resource development (improved quality and distribution of a quantitatively large workforce) will be necessary. , china has a unique opportunity to mobilise its resources and to harness global knowledge to achieve advances in health, compressing the time and reducing the scale of the disease burden that many other developed countries have had. [ ] [ ] [ ] [ ] [ ] how china fares is important not only for chinese people but also for the global health community. the global importance of china is assured by its size and scale, its wellspring of innovation, and its role in shared risks and interdependent solutions. in the future, china's global-health interactions will undoubtedly acceleratein areas such as science and technology, research and development, clinical trials, and new procedures such as organ transplantation. china will also be the source of social system innovations, such as its real-time online disease surveillance system. history has shown that china can produce and harness knowledge, create innovative approaches, and implement at large-scale eff ective solutions for both its own people as well as the world community. this report aims to initiate long-term collaboration between the lancet and china, together with the china medical board and who, including critically important partners, such as scientists outside china who have strong interests in working with chinese colleagues. the purpose of this collaboration is to introduce china's health system, achievements, and predicaments to the world and to foster scientifi c and institutional alliances that can strengthen the health-and ameliorate the adverse social and environmental determinants of health-of the chinese people. we are at the beginning of this relationship. our report, we hope, has the potential to catalyse progress towards enhanced human health and wellbeing in china. advances in medicine in the th century, along with an ageing population and changes in lifestyles, have altered the nature of diseases. malnutrition and traditional infectious diseases have been replaced by chronic non-communicable diseases and emerging infectious diseases. in china, more than % of deaths are caused by chronic non-communicable diseases. these increasing worldwide needs have placed biomedicine centre stage. the development of biomedical research in china, a country with · billion people, is a massive and unique challenge. initially when china opened its doors via policy tackling the challenges to health equity in china emergence and control of infectious diseases in china emergence of chronic non-communicable diseases in china injury-related fatalities in china: an under-recognised public-health problem china's human resources for health: quantity, quality, and distribution reform of how health care is paid for in china: challenges and opportunities china's health system performance biomedical science and technology in china evolution of china's health-care system traditional chinese medicine anthropology in china's health promotion and tobacco reproductive health in china: improve the means to the end china's hiv/aids epidemic: continuing challenges schistosomiasis control: experiences and lessons from china china's barefoot doctor: past, present, and future medical research ethics in china government and organ transplantation in china internal migration and health in china countdown to for maternal, newborn, and child survival: the report on tracking coverage of interventions key: cord- -gcmpatlb authors: errecaborde, kaylee myhre; macy, katelyn wuebbolt; pekol, amy; perez, sol; o’brien, mary katherine; allen, ian; contadini, francesca; lee, julia yeri; mumford, elizabeth; bender, jeff b.; pelican, katharine title: factors that enable effective one health collaborations - a scoping review of the literature date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: gcmpatlb advocates for a one health approach recognize that global health challenges require multidisciplinary collaborative efforts. while past publications have looked at interdisciplinary competency training for collaboration, few have identified the factors and conditions that enable operational one health. through a scoping review of the literature, a multidisciplinary team of researchers analyzed peer-reviewed publications describing multisectoral collaborations around infectious disease-related health events. the review identified factors that support successful one health collaborations and a coordinated response to health events across three levels: two individual factors (education & training and prior experience & existing relationships), four organizational factors (organizational structures, culture, human resources and, communication), and six network factors (network structures, relationships, leadership, management, available & accessible resources, political environment). the researchers also identified the stage of collaboration during which these factors were most critical, further organizing into starting condition or process-based factors. the research found that publications on multisectoral collaboration for health events do not uniformly report on successes or challenges of collaboration and rarely identify outputs or outcomes of the collaborative process. this paper proposes a common language and framework to enable more uniform reporting, implementation, and evaluation of future one health collaborations. ongoing and emerging health challenges such as infectious disease epidemics, bioterrorism, antimicrobial resistance, and natural disasters require a coordinated response from a highly diverse, collaborative, and trained health workforce. "one health" is a concept and approach intended to meet such demands. though loosely defined, a broadly accepted definition of one health describes it as "the integrative effort of multiple disciplines working to attain optimal health for people, animals, and the environment [ ] [ ] [ ] [ ] world organisation of animal health (oie), n.d.; world health organization, n.d). a one health approach recognizes that complex health challenges are beyond the purview of any one sector or discipline working in isolation [ ] and that a resilient health workforce must be capable of effective and collaborative prevention and detection of, as well as response to emerging health challenges. a one health approach, therefore, calls for collaboration across disciplines, sectors, organizations, and national borders in support of increasingly complex health challenges [ ] [ ] [ ] [ ] [ ] [ ] [ ] . while one health advocates increasingly support collaborative and multi-sectoral approaches to health challenges, no common language or metrics exist to uniformly describe and evaluate such efforts. few studies explicitly analyze the factors and conditions that support effective one health practices and collaborations. this hinders the ability of health professionals to learn from past experiences and improve upon current and future one health policies, partnerships, and practices. this paper seeks to address this gap by analyzing and identifying factors that enable effective multisectoral collaboration and response to health events. in this study, a multidisciplinary team of researchers reviewed a broad scope of literature describing collaborative and multi-sectoral approaches to past health events to understand how such collaborations are commonly described and evaluated and to identify and synthesize enabling factors for one health collaborations. this paper identifies twelve factors related to effective one health implementation and collaboration and concludes with a proposed framework for evaluating future multisectoral one health collaborations. the ultimate aim of this work is to support and improve multisectoral preparedness and response efforts. although its conceptual foundations date back hundreds of years, the formal global health construct known today as one health wasn't officially recognized by international and scholarly bodies until [ ] . the hiv/aids pandemic in the s and the hanta virus outbreak in , made clear that emerging disease threats can cross national borders, cultures and species. with that came a broader recognition that animal and zoonotic diseases pose a serious threat not only to human health but to global health security. policy makers and health practitioners looked to collaborative health efforts as a response to these emerging challenges [ ] . the subsequent decades which were marked by unprecedented global interconnectedness and human mobility [ ] were associated with threats to global health security, including manmade threats, such as the use of anthrax as a bioweapon, and emerging diseases like sars and avian influenza. these challenges necessitated the need for a more formal coordinated action from countries, regions, and the global health community at large to address such health threats. in order to address the afore-mentioned challenges, there have been emergence of major health initiatives and frameworks such as the global health security agenda, the international health regulations-joint external evaluations (ihr-jee), the world health organization (who)-world organisation for animal health (oie) operational framework for good governance at the human-animal interface [ ] , and the world bank's one health operational framework [ ] . a common thread among these initiatives is the emphasis on multisectoral and transdisciplinary collaboration and a call for strengthening human, animal and environmental health systems through a one health approach. the global health community, including those already engaged in one health, continue to grapple with the fundamental questions of what characterizes a successful one health approach, including how to set goals, establish frameworks, facilitate collaborative work, and how to process and measure outcomes [ ] . efforts to measure one health programmatic outcomes and operations are necessary for the improvement of collaborative efforts. this article supports such efforts by ) identifying key factors that support effective collaboration around health events and ) proposing a framework for documenting and evaluating one health collaborations in a more uniform and systematic manner. collaboration is an inherent and explicit part of the one health approach which calls for the active engagement of institutions, managers, and health practitioners across disciplines and sectors [ ] [ ] [ ] [ ] . despite widespread recognition of the importance of a one health approach, there exists a gap in the literature regarding what constitutes a successful one health collaboration. this study draws upon the existing public affairs literature on collaborative, or 'crossboundary' collaborations to understand which factors enable successful collaboration around health events. review of the literature on collaboration. scholars of public policy, organizational partnerships, team science, and multisectoral collaboration have produced a series of theoretical frameworks to describe cross-boundary collaborations and identify which practices make them successful [ ] [ ] [ ] . the focus on collaboration and partnership is not unique to any one discipline, yet there is very little cross-fertilization of research across disciplines. this research builds upon the existing literature on cross-boundary collaborations and applies it to one health collaborations. the conceptual framework for this study focuses on three critical phases of a successful cross-boundary collaboration: adequate starting conditions, an effective process of collaboration, and attention to the outcomes of collaboration [ ] [ ] [ ] [ ] [ ] . starting conditions. there is a general consensus in the literature on cross-boundary collaborations that starting conditions-the conditions in place before any collaborative process begins-impact the process, structures and outcomes of collaborative engagement. these include prior history (e.g. successes, failures, existing partnerships), the environment (e.g. resource imbalances, stakeholder incentives), and relational dynamics (e.g. balances of power, who convenes or facilitates the collaboration, and how and by whom problems are defined) [ , ] . the presence or absence of such conditions influences successes and challenges encountered during the collaborative process. process. beyond starting conditions, many scholars point to the process of collaboration itself and the structures in place to support effective collaboration [ , , , ] . although the terms used for collaboration vary, scholars focusing on the process of collaboration point to the importance of leadership, shared goals, trust and mutual understanding, institutional structures and resources, communication, and data management. measuring outcomes. a review of the literature on collaboration suggests a lack of validated metrics for measuring collaborative effectiveness and performance. several scholars of cross-boundary collaborations, citing works published between and , highlight the importance of measuring the outcomes of collaboration and lament the challenges of describing and evaluating collaborations in a uniform way [ , , , , , [ ] [ ] [ ] . this underscores the importance of understanding which factors support collaborative efforts, and how teams can evaluate their performance and outcomes in association with these factors. the literature on cross-boundary collaborations and its attention to the starting conditions, processes, and outcomes of collaborative approaches have informed this study on the factors that enable effective one health collaborations. the following questions guided this study: what factors (systems, structures, processes, skills, competencies, decisions, and actions) enabled two or more disciplines or sectors to collaborate effectively in a health event? a scoping literature review was conducted to identify key factors that facilitate multisectoral collaborations around major health events such as disease outbreaks using published accounts of actual health events. a scoping review, in contrast to a systematic review, is well-suited for a field such as one health that is still relatively new and evolving, as the method allows for assessment of emerging evidence, as well as a first step in research development [ ] [p. ]. due to the lack of a common language and framework for describing one health collaborations, this scoping review builds that foundation by providing a broad overview of one health collaborations and supporting the synthesis of key concepts, evidence, and research gaps [ , ] . the scoping review was initiated by a multidisciplinary team in january . the team members were composed of individuals with expertise in veterinary medicine, public health, public policy, organization and management leadership studies, international development, monitoring and evaluation, and education. because the researcher is central to the methods and analysis of qualitative research, it was important to select a transdisciplinary research team that could work effectively to address the research questions and to illustrate the disciplines that were represented in the transdisciplinary approach employed for this scoped review. selection of relevant articles. the search included peer-reviewed articles available todate in the u.s. national library of medicine's pubmed database that were searched using specified mesh (medical subject headings) terms. although the multidisciplinary research team has extensive experience in one health, they were not trained in sensitive search strategies [ ] . the research team thus elected to work with a university of minnesota research librarian to develop mesh terms for this study. table provides a list of the key terms used to identify articles discussing multisectoral health events and collaborations. to avoid tautology, it was a deliberate decision to not use "one health" as a search term. instead, drawing upon the researchers' extensive experience in one health, various terms were used to describe one health and similar multidisciplinary and cross-sectoral health collaborations. the underlying assumption was that any articles explicitly addressing one health would be captured using these key terms. this initial mesh search identified , non-duplicated articles. this scoping review was an inductive study of the literature and was conducted in order to support more hypothesis driven research for one health. by design, the authors elected to limit this literature review to the pubmed database at the outset of the study. pubmed is peer-reviewed and peer-led database. articles are selected and included based on scholarly and quality criteria by literature review committees and are tagged by keyword and by article structure, contributing to more accurate retrieval than other databases (e.g. google scholar); accurate retrieval supports the search results are reproducible and reportable, which is critically important for a scoping review of the literature in which it is important for other researchers, no matter their location, to repeat the study. the decision to use one database reflects the exploratory nature of this study and the author's intent to propose further hypothesis-driven research that may include additional databases. this methodological choice is in line with arksey and o'malley ( ) who attest that decisions must be made at the outset of a study to clarify reasons for the coverage of the review in terms of time span and language [ ] [p. [ ] [ ] . initially, citations and abstracts of these articles were screened in two phases. the articles were reviewed for inclusion based on the criteria outlined in table . in the first screening, abstracts met initial inclusion criteria and full articles were procured and reviewed. in the second phase of screening, two further criteria were included to better achieve scoping review objectives. the research team divided into transdisciplinary pairs which included a reviewer from the health sciences and one from the social sciences. each of the articles that met the initial inclusion criteria were divided among the team members and then independently reviewed according to the modified screening criteria. articles were included if both reviewers agreed that they met all initial requirements. in instances where the transdisciplinary reviewers did not agree, the articles were brought to a full research team meeting and reviewed jointly until consensus among all researchers was achieved. this same method of collaborative review was used for the second round of screening and resulted in articles for the final analysis. the prisma diagram below (fig ) illustrates the article search, screening, and review process. . the health event discussed involved an infectious disease challenge; and . the case or event involved at least two sectors or disciplines. inclusion criteria: . articles met initial screening criteria and were included if they met the following targeted requirements: . the article provides a retrospective analysis of an actual health event; . the case or health event involved a noteworthy (describing successes or challenges encountered during health event) interaction among at least two sectors or disciplines. exclusion criteria: articles were excluded if they failed to discuss any specific aspects of collaboration, even if they generally acknowledged the importance of multisectoral collaboration. https://doi.org/ . /journal.pone. .t analysis. the interdisciplinary team conducted an analysis of the articles that explicitly addressed multisectoral collaboration in response to an actual health event. each reviewer coded approximately - selected articles using the qualitative data analysis software, maxqda [ ] . descriptive codes were identified in advance to ensure that baseline data reflected the one health aspects of the articles reviewed. all other codes emerged from the data using a grounded theory approach [ , ] . preliminary and axial coding procedures are outlined in the following section and ensured that inductive and deductive thinking could be related. preliminary coding. a set of predetermined, descriptive codes were used to denote the location and nature of the health event in the articles, including specific infectious agents, factors that enable one health collaboration: a scoping review relevant disease vectors or hosts, and the various entities involved in the collaboration. each paper was coded for the predetermined codes outlined in table . predetermined codes were also used to identify the entities involved in each health event response. the team used the code "roles" to identify individuals or groups who participated in the coordinated response in a formal role based on individual expertise and formal training. while many of these roles represent professions in the health sciences, this category also included representation from the social sciences, media and community relations, government, and engineering. other articles focused on types of training, identified by the research team as "disciplines," (e.g., clinical epidemiology [ ] or food safety [ ] ), or specific professions (e.g., toxicologist [ ] or information technology specialist [ ] versus specific professions). a third type of classification in the literature was more general categorization of sectors involved, such as the traditional designations of public, non-profit, and private/for-profit. axial coding. axial coding was used to construct linkages between "data sets" or, in this scoping review, articles regarding intersectoral collaboration. axial coding is a qualitative research technique to relate data together in order to reveal codes, categories, and subcategories, as well as patterns in the data [ ] . this grounded theory is an iterative process that combines inductive and deductive thinking. each article was first coded to identify any area of text where authors analyzed collaboration around a specified health event. in this process, it became quickly apparent that the review team would need to differentiate between actual and hypothetical forms of collaboration reported. all articles included in the analysis at this stage were retrospective analyses of actual health events, yet many were actually prospective in their analysis and discussion. as an example, several of these articles included suggestions based on what should happen in an ideal scenario, rather than what occurred in practice, thus leaving out key details of the actual event. therefore, a first round of organizing codes differentiated between collaborations that actually happened versus ideal scenarios and hypothetical lessons, allowing the research team to focus the analysis on what actually happened ( table ). the text was further coded to reflect whether the authors were reporting a success factor of collaboration, or a challenge of collaboration. both the successes and challenges reported in the literature were related during the grounded theory thematic analysis and informed the final thematic results reported. after the first round of axial coding was conducted to organize the data, the authors employed a deductive framework developed from the review of literature on multisectoral collaboration [ ] . aligned with this framework, the research team distinguished between starting conditions for collaboration, the process of collaboration itself, and the outcomes of collaboration (table ) . finally, the review team re-examined the passages coded as "actually happened" and "successes". these codes were then related to the deductive codes of starting conditions and process-based factors. an excel table was used to organize axial codes into a table of final results. limitations. the primary limitations of this scoping review are three-fold. first, the literature analysis relies on peer reviewed publications alone, which may have underrepresented collaborative efforts that are more commonly encountered in grey literature. future work may be expanded to include these types of sources. second, there was no consistent framework or language for reporting the successes or challenges of collaboration, and thus, important content may have been missed during the search and review [ ] . the scoping review team tried to overcome this with two strategies, which included building an expanded list of search terms and conducting an iterative review process using two independent transdisciplinary reviewers. both methods offset this limitation and might have minimized the likelihood of missing specific content. third, the researchers could not identify specific metrics for evaluating performance and collaboration in the literature. this meant that an evaluation baseline was not present. however, the research team believes that the final subset of articles represents a diverse crosssection of transdisciplinary efforts around emerging health events. the scoping review yielded peer-reviewed publications explicitly addressing multisectoral collaboration in response to an actual health event. this section describes the nature of the one health collaborations analyzed as well as the various factors that enable one health collaboration. types of one health events analyzed include natural disasters, infectious disease outbreaks, endemic disease, bioterrorism, and biosecurity preparedness. in each of these cases, the underlying multisectoral collaboration was either a preparedness (planned or ongoing collaboration) or response (emergency or ad hoc collaboration) effort. the sample included one health events from around the world. most articles addressed health events in europe/eurasia ( %), the americas ( %), and asia ( %). less represented in this sample were health events taking place in africa ( %), oceania ( %), and the middle east ( %). most health events involved a specific infectious agent ( %), while the remaining % focused on infectious disease challenges such as hospital infections, pest management, or tsunami response. a total of different infectious agents were coded. among the infectious agents identified, % were bacterial, % were viral, and % were protozoal (e.g. malaria). % of these agents primarily affect humans and % are predominantly animal-related. % of the agents were food and water-related, % were insect related, and an additional % were related to environment. overall, % of the infectious agents were considered zoonotic, meaning they spread between humans and animals. relevant disease vectors or hosts represented in more than one publication included bats, cattle, poultry, horses, swine, humans, mosquitoes and midges. involved parties or entities played varied roles and represented diverse disciplines and sectors, as illustrated in table . thematic findings are presented according to the one health collaboration framework, which distinguishes between individual, organizational, and network factors that enable multisectoral and transdisciplinary collaboration at the onset and in the process of addressing a one health event. the team ultimately created organizing categories that reflected the individual, organizational and network levels of collaboration (table ) . these categories were informed by a review of the literature; for the purposes of this discussion, the definition of network is provided by emerson and nabatchi [ ] , and is defined as "the processes and structure of public policy decision making and management that engage people constructively across the boundaries of public agencies [organizations], levels of government, and or the private and civic spheres in order to carry out a public purpose that could not otherwise be accomplished," [p. ]. within each level, the review team created groups of subcategories to further organize codes. the research team identified key factors that support successful multi-sectoral collaborations around major health events. at the individual level, these factors include ) education & training and ) prior experience & existing relationship. organizational factors include ) organizational structures, ) organizational culture, ) human resources, and ) communication. finally, network-level factors include ) network structures, ) relationships, ) leadership, ) management, ) available & accessible resources, and ) the political environment. these final individual, organizational and network factors were then further characterized factors that enable one health collaboration: a scoping review according to their relevance at the start of a collaboration "starting condition" or during the process "process-based" factors of collaboration. the researchers identified that the organizational thematic factors were relevant to both starting conditions and process-based factors so were not separated. the final results of this literature review are thus presented in table . the researchers also coded each paper for outcomes. of all the articles coded, only articles reported on outcomes of collaborations. the outcomes reported included: ( ) cost reduction; ( ) decreased mortality; ( ) decreased morbidity, ( ) multisectoral development opportunities resulted from the collaboration; ( ) improved safety; ( ) effective use of available resources. table . final axial coding process included both inductive and deductive codes and reflects emerging themes for successful collaboration. starting condition factors initial deductive code (table ) process factors initial deductive code (table ) individual (emergent axial code table ) preemptive technical training/ continuing education [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] disease specific technical training [ , , ] preemptive collaborative training [ , ] strong public-sector led training [ ] training and capacity building provided a platform for better collaboration for outbreak [ ] ngos support gov. through staff training [ ] participatory epidemiology training [ ] prior experience & existing relationships (informal/formal) pre-existing multisectoral relationships [ , [ ] [ ] [ ] [ ] previous experience collaborating for health events [ , , ] ad hoc "just-in-time" training shared training & organizational alignment; aggressive, rigorous, just-in-time, and critical trainings for key positions and critical events with monthly follow-up meetings to support compliance [ , ] training and capacity building provided a platform for better collaboration for outbreak response [ ] instituting multisectoral disease specific training; ongoing training-for new and existing systems [ , ] organizational (emergent axial code table ) shared response guidelines [ , ] structures frequently included policies/protocols [ , ] reporting -management protocol -task management -response plan -communications/ communication strategy [ , ] infection planning, control and traceback procedures [ ] systems reporting, laboratory systems [ ] surveillance systems [ , , ] planning; iterative improvement of systems [ , , ] information management system/ database [ , , , ] information sharing (data available and useful) [ , ] ) tool sharing during response [ ] lab systems in place [ ] online system for hr recruitment [ ] intentional multidisciplinary engagement, collaborative capacity [ , , , ] standard operating procedures [ ] interoperability [ ] needs assessment and prioritization [ , ] culture leadership, accountability, ownership, trust, transparency of processes, systems based thinking, cultural awareness and engagement leadership to support the iterative and developmental review of collaborative processes [ ] strong, engaged leadership [ , , , ] accountability; ownership [ , ] cultural engagement; engagement; diversity/ involvement of community [ , ] trust [ , , , ] transparency [ , , ] need to understand each other's' processes [ , ] systems based thinking/ approach [ , ] cultural awareness; engagement of diverse stakeholders to reflect community needs [ ] credibility [ ] existing relationships [ ] institutional knowledge (experience and relationships) [ , ] revise and revisit mandates based on lessons learned [ , ] clearly defined roles and responsibilities [ , , ] resources available and accessible (including human resource allocation) [ , ] informed staff/ staff are aware of systems in place, increased engagement of staff [ , ] reflexive workforce reflexive human resource protocol to ensure positions are adequately filled & workers are incentivized [ , ] reflexive approach [ , ] adaptability to rapidly changing context [ ] rapid start-up response; shared response guidelines [ ] (continued ) factors that enable one health collaboration: a scoping review multi sectoral coordinating mechanisms/ platforms for engagement [ , , , , ] memoranda of understanding, terms of reference or bilateral agreements to support the development of existing relationships that promote ongoing engagement [ , , , ] in this discussion, the research team suggests thematic factors that may be used by practitioners involved in one health activities to more systematically assess the successes and challenges of multisectoral collaboration, including those contributing to successful outcomes. further research is needed to refine and validate these factors and ultimately support more uniform and rigorous assessments of one health collaborations. the axial coding process allowed for factors reported to facilitate or discourage successful collaboration to be categorized as either a relevant starting condition of collaboration, or as relevant to the process of collaboration. during the data analysis, certain themes within each category of individual, organizational and network factors emerged as relevant to "setting the stage" for effective collaborative processes, while other factors were essential to maintaining the process of collaboration itself. the researchers found that this distinction was critical in our understanding of how successful collaborative processes are initiated. the starting conditions presented in this paper represent the collaborative preparedness and planning necessary to support effective one health processes. in addition, the process of collaboration allows for the emergence of new ways of collaborating. this symbiotic relationship between starting conditions and process, allows us to view the entire system of collaboration. in this system, starting conditions influence the process of collaboration, and the process itself can lead to improvement of structures and processes that will now inform improved starting conditions. this cyclical and emergent process is inherent in collaboration and must be accounted for when considering evaluation and systems-based improvements. individual factors. relevant success factors at the onset of a one health event include an individual's education and training, as well as prior experience and existing relationships. many authors identified existing or previous education and training as enabling factors for collaborative success [ , [ ] [ ] [ ] , , , ] . formal technical education and training of individual workers prior to a health event was critical to prepare the necessary human resources for response efforts. authors noted that foundational technical training during an event was often not possible [ , ] , but that preemptive and collaborative planning did support the development of key relationships, and in some cases, the development of shared protocols used in the response. the absence of formalized training opportunities before an event, both individual technical training and collaborative, were frequently reported as a gap and a challenge to effective one health response [ ] [ ] [ ] ] . shared competencies were suggested as a strategy for standardizing protocols and performance across multiple individuals and organizations [ ] . multiple sources also reported the importance of prior experience in collaborative response efforts and how this established existing relationships to support the work, both formal (i.e. required communication through standard operating procedures) and informal (i.e. loosely structured and based on personal relationships and ongoing professional engagement) [ , , , , , ] . when instituted before a health event occurs, these starting conditions were reported to support a more effective collaboration processes. individual factors that supported the process of collaboration were most frequently reported as workers having access to necessary education and training that was available ad hoc or as "just in time" training to support operations during the health event. examples reported include the use of shared training across organizations to additionally support institutional alignment and partnership with community-level organizations to provide training [ , , ] . many of these trainings were reported to be rigorous and responsive with continuous follow-up to support compliance [ , , ] . williams et al [ ] discussed how ongoing multisectoral disease specific training supported workers to operate within new and existing systems while simultaneously sharpening their technical competence. these training and capacity-building opportunities were reported to provide a platform for better collaboration for outbreak response [ ] . however, ad hoc trainings do not replace or diminish the need for foundational technical training, as formalized education and training were reported as a critical starting condition to facilitate quick mobilization in the case of a health event. our literature review uncovered the role for both strong university-based education and training, and the role that ad hoc or "just-in-time" training can play to meet immediate operational needs during process-based response. organizational factors. factors reported to enable organizational-level collaboration were broadly applicable to both the starting conditions and the processes of collaboration. organizational structures, culture and resources were cited as important elements for creating an enabling environment for effective one health collaboration. the organizations serve to connect the individual worker with a network of one health actors. the organizational structures that support collaboration were often discussed as a success factor. these structures include, but are not limited to, the policies and protocols or systems established within organizations to support technical implementation and collaborative efforts. policies and protocols reported to be supportive included technical guidelines and standard operating procedures, as well as management, response and communication strategies and protocols [ , , , , , ] . in addition, organizations reported the need for functional systems for information and resource management and sharing and reporting both surveillance and laboratory results [ , , , , , , , , , ] . these systems were reported to benefit from being adaptive, flexible/reflexive and improved through iterative feedback and monitoring and evaluation [ , , , ] . organizational culture was reported in multiple key areas [ , , , , , , , , [ ] [ ] [ ] ] . the role of organizational leadership was discussed at length in many of the reviewed publications. authors recognized and identified the importance of having strong and engaged leadership [ , , , ] and the need for leadership to support the iterative and developmental review of collaborative processes [ ] . in addition, organizations benefited from having a culture that supported accountability, ownership, cultural engagement and diversity [ , ] . trust and credibility were consistently reported as a key element of organizational success [ , , , ] , as was the need for both an understanding of each other's processes and systems based thinking [ , , , ] . authors reflected on the importance of cultural awareness, transparency of communication processes [ , , , ] and the engagement of diverse stakeholders who were able to reflect community needs [ ] . human resource-related factors appeared in all three levels of analysis. research suggests that workers need to be trained at an individual level, have defined roles and responsibilities at an organizational level, and need to be able to mobilize their efforts at a network level. at an organizational level, human resources are made up of individual contributors and also function as collective entities that reflect employees' prior experiences, existing relationships, and the collective institutional knowledge of its members [ , , , ] serve to benefit the organizations in which they work. clear roles and responsibilities were consistently reported [ , , ] , as well as awareness of systems in place to support ongoing engagement, operations and information sharing [ , ] . additionally, several authors highlighted the importance of a reflexive workforce, i.e. human resources that were readily available and could be mobilized quickly and efficiently to respond to health event in a rapidly changing context [ , , , ] . network factors. starting condition factors reported to enable collaboration at the network level included network structures, existing relationships, available resources in the face of a health event, and the political environment in place to support these efforts. pre-existing network structures were reported to provide a foundation for effective collaborative efforts to occur across participating organizations. established multisectoral coordinating mechanisms (mcms), also referred to as one health platforms or joint task forces, were often reported as key to assisting with collaboration across a network [ , , , , , , , ] . organizational and network structures provided operational standards that crossed relational and organizational boundaries at all levels of the system-individual, organizational and network-which supported the development of formal relationships at each level. analysis suggested that these systems and relationships need to be in place before the health event. mcms provide a formalized operating foundation in which organizations and individuals could contribute, and formalized roles and responsibilities supported effective human resource mobilization in both organizations and networks [ , , , ] . these structures were often supported by formal policies or agreements such as bilateral agreements or memoranda of understanding (mous) [ , , ] . in addition, operating procedures such as the incident command system (ics) also supported effective mobilization of multiple organizations within the mcm [ ] . finally, the importance of formal structures were repeatedly emphasized as a response to "lessons learned" during challenging responses. on the contrary, lack of existing structures was reported to prevent efficient multisectoral engagement in the preparedness and response to health events [ , , ] . several sources indicated that reporting structures and policies at local, regional, national and international levels support continuity of response and effective implementation in response to health events [ , , , , , , , , ] . these reporting structures and policies allowed for information flow between stakeholders, and the coordination of response efforts across a diversity of individuals and organizations participating in preparedness or response efforts [ , , , , ] . established structures created a foundation for network relationships that support effective outbreak response to a health event [ , , , , , , ] . development of formal and informal relationships prior to a health event allowed individuals, organizations and networks to more effectively respond once an emergency arose. the existence of structural agreements in any form such as mcms, mous, shared standard operating procedures (sops) or bilateral agreements were reported to support the further development of existing relationships to promote ongoing engagement prior to and throughout a health event [ , ] . preemptive planning for potential disease threats was reported to strengthen connections and relationships and support multisectoral disease training, sometimes leading to shared protocols [ ] . additionally, the creation of common goals [ , ] and clearly defined, previously established, roles and responsibilities for individual actors and network partners were reported as necessary in network operations [ , , , , , ] . cultural awareness and the inclusion of diverse stakeholders from government, nonprofit, and private sectors from the national to community level, was consistently reported as a success factor for collaborative efforts if included from the start [ , , , , , , , , , ] . availability of resources, including human resources, that can be easily and efficiently mobilized in a health event was considered an important factor for response [ , , , , , , , , , , ] . authors also noted the importance of a supportive political environment to aid in the development and institutionalization of effective collaborative structures [ , , , ] . a supportive political environment was reported to enable the flow of available financial, human and material resources and empowered decision making [ ] . readily available resources supported rapid mobilization of collaborative efforts when a health emergency occurred. this is particularly impactful given that the absence of these resources and actions was noted across the literature as challenges to effective health response. network leadership and management processes were critical to effective multisectoral response efforts. leadership engagement during a health event allowed for the mobilization and needed support for management processes. by utilizing existing structures and decision-making power, leaders and lead agencies can support managers and the process of management across organizations and networks. emergency response protocols, such as the ics, were frequently reported as mechanisms to this end, by concretely providing a leadership and management structure to support ongoing multi-organizational response. it was particularly useful for identifying a lead agency and establishing structures for regular meetings and communications. in the process of collaboration, relevant network factors included network leadership, management, and the effective and efficient mobilization of resources for response. for example, strong and engaged network leadership was noted as an important success factor for collaboration. when established prior to a health event, factors reported to support network collaborations included identifying a lead agency [ , ] , promoting information sharing and joint decision-making across a network [ , , ] , and convening regular multisectoral meetings [ , , ] . in addition, strong leadership was integral for strategic risk communication across the network [ ] . effective network management during an outbreak was reported in the areas of management practices, monitoring and evaluation (m&e), communication, awareness and ongoing stakeholder engagement. management practices included case and task management through the mcm [ ] , regularly scheduled meetings [ , , ] and development of shared response guidelines and management protocols across the network [ , ] . these management practices, when paired with existing structures, can support rapid start up response in the face of health events [ ] . monitoring and evaluation allowed for the iterative review of the collaborative processes during response efforts, as well as the outcomes of the collaborative process [ , , , , , , ] . monitoring and evaluation was reported as integral in being able to show the outcome of interventions as beneficial or not [ , , ] . the importance of communications cannot be overemphasized and was repeatedly reported as an integral factor for building relationships, trust and supportive organizational culture, and for contributing to effective response processes. both the characteristics and the methods of communications were highlighted as important. characteristics of successful communication included the need to be frequent and honest [ , ] ; timely and consistent [ ] ; reflexive and flexible [ ] and prioritized (risk-based) [ ] , and streamlined [ , ] . additionally, characteristics included the need for communications that build trust [ ] and have a clear purpose [ , , ] . these elements were widely reported to support effective communication within and across organizations [ , , , , , , , , , , , , , ] . communication was deemed most effective when it was regular, frequent, and designed to foster awareness and support the engagement of a range of stakeholders, from local through national, regional and international levels. the mcms, or the use of ics, were often cited as important organizing structures for ongoing communication during a health event, supporting meetings, data collection and information sharing [ , , , ] , underscoring the importance of starting conditions to support communications. multiple methods of communication were reported including electronic communications, list-servs, contact lists and regular meetings; in many cases these were supported through existing mcms [ , ] monthly meetings [ , , ] and establishing clear lines of communication [ , , , , ] were reported as critical. these methods were supported by the use of a variety of methods and platforms such as press briefings, websites, television, newspaper, teleconferencing, listserv, available contact lists, local/ regional/ cross-border meetings and periodic reporting [ , , , , , , ] . additionally, leadership and management processes played a key role in supporting or challenging communication; high-level support, resource allocation, and use of good practices across an organization are foundational for good internal and external communication. closely linked with communication was the reported importance of building shared awareness and diverse stakeholder engagement. awareness included information sharing, education campaigns, jointly coordinated communications and public release of reports with all members of the network and with the public [ , , , , , , , , ] . engagement of diverse stakeholders before, during, and after the response was reported as essential; these stakeholders included community and local actors, national governments, intergovernmental organizations, and operating partners [ , , [ ] [ ] [ ] ] . to facilitate communication across stakeholder groups, adams et al. [ ] and butler et al. [ ] underscored the importance of transparent joint communications specifically between responders and community leaders for efficient and effective response. butler et al. [ ] further reported the success of joint interviews held with stakeholders to support shared understanding of response needs. diverse partners, including foreign militaries, were reported to support foundational infrastructure that allowed other international partners to stay involved when supporting a response effort when they would not have been able to serve effectively on their own [ , , ] . common goals, common interests, and perspective sharing amongst stakeholders were reported to support an effective response to a health event [ , , ] . resource mobilization and allocation during an event, relies heavily on the starting conditions, as well as the communication, leadership and management during the process of collaboration. a number of authors pointed to the importance of being able to mobilize both the material and human resources. once again, the involvement of diverse stakeholders, the use of mcms and management systems such as ics were attributed with the ability to draw upon existing resources. processes characterized as successful included establishing a supply chain with standardized access, delivery, allocation and flow [ , , , ] . human resource mobilization benefited from online recruitment [ ] as well as reflexive human resource protocols to ensure that positions were filled and workers are incentivized and rewarded for participation [ , ] . outcomes reported. although the researchers created a code to capture reported outcomes of collaborative efforts, only a small number of authors reported outcomes of their collaborative processes. outcomes were consistently missing or under-reported in the literature reviewed, and this is likely a result of one health outcomes being difficult to characterize. the few reported included the outcomes of cost reduction and improved safety [ ] , decreased mortality [ ] , reduction in mrsa (methicillin-resistant staphylococcus aureus) cases [ ] , increased stakeholder buy-in [ ] , and a report that multisectoral professional development opportunities resulted from the response [ ] . however, implementation of m&e activities was one of the major gaps in the reports of one health collaboration. the majority of articles reviewed never discussed the evaluation of either the process of collaboration or the resulting outputs or outcomes. this creates a pivotal challenge in understanding how to improve one health operations. the authors noted that outcomes of collaborative efforts were consistently missing or underreported in the literature reviewed. language in collaboration. language used to describe one health work continues to be a challenge when working across disciplines. each discipline contributing, and specifically those authors reporting on these interactions, bring their own nomenclature and vernacular [ ] . as also discussed in the limitations of this work, we encountered challenges in how authors reported on which entities were involved in the response to a health event. organizations, sectors and disciplines were characterized in different ways, making is difficult to find a standard classifying system for the coding. considerations for the evaluation of one health. despite an emphasis on the importance of iterative improvements to collaboration, the implementation of monitoring and evaluation activities was one of the major gaps in the reports of one health collaboration. the majority of articles reviewed never discussed the evaluation of either the process of collaboration or the resulting outputs or outcomes. this creates a pivotal challenge in understanding how to improve one health operations. it became clear in the literature review that there was no standard framework for how to evaluate one health processes [ , ] . although networks and collaborators such as the network on the evaluation of one health are making important advances, practical evaluation tools are still needed [ ] . some authors from public affairs, such as emerson and nabatchi ( ) et al. [ ] have proposed a framework for evaluating outputs, outcomes, and what they refer to as "adaptations" of collaborative processes [ , ] . their work is one of the first to propose an integrated framework that captures collaborative results at all levels of the system, from the target population to the participating organizations, and the network as a whole. the results of this scoping review are intended to support the next steps in supporting one health evaluation. using the factors uncovered in this review, the authors have outlined a reporting framework ( table ) that may help practitioners consider their activities in light of important collaborative starting conditions and process-based factors. the researchers propose this to the one health factors that enable one health collaboration: a scoping review community as a tangible next step that may lead to more effective reporting and potentially evaluation of one health efforts in the future. the proposed framework in table recognizes that each factor will be operationalized within the context of the health event and that flexibility in reporting is imperative. this framework may be useful in providing a common language on how practitioners discuss and report on their one health efforts. in the process of conducting this research, the research team encountered many of that same collaborative challenges as described in the articles reviewed. the research team had to negotiate and re-negotiate ways of working, integrate differing points of view and assign roles in ways to leverage expertise but not reinforce bias. additionally, the researchers had to establish and meet internal standards while also achieving the outward facing objective of finishing the analysis and writing of this article. finally, as with any transdisciplinary work, language was consistently a problem. the inherent challenge of interdisciplinary work is in how we talk about collaboration and the terminology we use to describe both theory and practice. for the research team, creating clear definitions supported the development of a common language. differing approaches can be a significant barrier when active collaboration is not structurally supported, valued, and continuously monitored for health and effectiveness. our efforts reinforce the need for training for those skill sets that fall beyond technical sector-specific training. when grappling with the question of which skills were most important in our collaborative process, we determined that the shared objective of collaboration was the foundation for our ability to integrate the differing expertise that each team member brought to the process. simply, we took continual action to achieve our combined goal including reading new literature, considering new frameworks, learning new things, and asking many questions. the subsequent challenge is, of course, that there are very few formal opportunities to gain access to training around these competencies and mindsets in one health teams. most often, as in our case, it is an ad hoc process that rests on the motivations, shared values, and time available within a team to develop in this way. our review suggests that, while this approach worked for us, it would not be a time or resource-effective approach within the context of a health emergency. thus, one health approaches need to be evaluated to help practitioners decide when and how to most effectively collaborate for their intended purposes. of the , article abstracts screened, only met initial inclusion criteria and the full research articles were obtained. of that subset of articles, only discussed the successes, challenges and lessons learned from operational one health response to a health event. a majority of the articles focused broadly on the need for collaboration between multiple sectors or disciplines with little attention to what factors enable an effective one health response effort. the low number of included articles reflects a broader challenge for the one health community, suggesting the necessity that one health researchers move beyond discussing the inherent need for one health, to actually reporting on the processes, outputs and outcomes of their collaborative efforts. as such, no consistent framework or language was found to report on the process, outputs or the outcomes of one health work in the articles reviewed. in the analysis, the research uncovered factors that supported successful health event response. the researchers were able to make important advances by characterizing these factors as important at the start of collaboration or relevant to the process of collaboration. using these factors, the researchers propose a one health reporting framework which when used to report on one health collaborations, can support the further refinement and identification of success factors for one health. these factors may serve as the basis for developing evaluation metrics and the iterative improvement of 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sharing and public communication public health communication with frontline clinicians during the first wave of the influenza pandemic department of defense west nile virus surveillance in collaboration, cholera, and cyclones: a project to improve point-of-use water quality in madagascar a collaborative strategy to tackle tuberculosis in england north india: delivering dots via collaboration with private providers and non-governmental organizations a blueprint to evaluate one health. front public heal key: cord- -fo lq sb authors: zakaria, nasriah; alfakhry, ohoud; matbuli, abeer; alzahrani, asma; arab, noha samir sadiq; madani, alaa; alshehri, noura; albarrak, ahmed i title: development of saudi e-health literacy scale for chronic diseases in saudi arabia: using integrated health literacy dimensions date: - - journal: int j qual health care doi: . /intqhc/mzy sha: doc_id: cord_uid: fo lq sb objective: health literacy has become a global issue, and it is important that patients and individuals are able to use information technology to access health information and educational services. the research objective is to develop a saudi e-health literacy scale (sehl) for measuring e-health literacy among saudis suffering from non-communicable diseases (ncd). methods: overall, relevant papers in related interdisciplinary fields were reviewed to select the most useful literacy dimensions. from these articles, we extracted the most common dimensions used to measure e-health literacy across the disciplines. multiple workshops with multidisciplinary team members reviewed and evaluated items for sehl. results: four key aspects of e-health literacy—use of technology/media, information-seeking, usefulness and confidence—were identified and integrated as e-health literacy dimensions. these will be used to measure e-health literacy among saudi patients with ncds. a translation from arabic to english was performed in order to ensure that translation process was accurate. a sehl scale was developed to measure e-health literacy among saudi patients. by understanding e-health literacy levels, we will be able to create a patient-education system to be used by patients in saudi arabia. conclusions: as information technology is increasingly used by people of all ages all over the world, e-health literacy has been identified as a key factor in determining health outcomes. to date, no comprehensive scale exists to assess e-health literacy levels among speakers of arabic, particularly among people with ncd such as diabetes, cardiovascular diseases and hypertension. literacy is defined as the ability to read and write, whereas health literacy refers to the ability to understand and use health-related information to achieve good health [ ] . e-health literacy refers to the ability to use information technology (it) to improve health outcomes. this study focuses on e-health literacy among patients with non-communicable diseases (ncds). worldwide, million people have died from ncds. in saudi arabia, ncds accounted for % of the national mortality rate [ ] . a major public health problem is diabetes, which is one of the four ncds prioritized by the world health organization (who) [ ] . the prevalence of diabetes has almost doubled globally since , and affecting . % of the world's population in [ ] . prevention requires patients to understand steps and procedures for monitoring their diabetes, and management of diabetes may involve taking insulin or other medication in a consistent manner. therefore, who recommends addressing the key gaps in patients' knowledge in the disease and related health issues. with technology being available literally in everyone's hand, e-health literacy is a key component for disseminating knowledge and ensuring that patients maintain good health. no studies have explored e-health literacy among patients in the middle east. among middle eastern countries, saudi arabia has the highest number of people with internet access: . % of the population [ ] . saudis, especially the younger generation, are increasingly using it to access health information [ ] , and health practitioners and institutions are frequently accessing the internet for information. during the mers corona-virus outbreak in - , for example, the ministry of health used an e-platform, namely twitter, to alert the public about the epidemic as well as to promote health programs. in high-income countries, healthcare efforts can be maximized using it. there are numerous studies on the use of e-health or health it for prevention, treatment, health maintenance and wellness. for example, mobile applications (apps) have been developed to provide information on how to treat cardiovascular issues and diabetes. wellknown websites such as webmd [ ] and the us centers for disease control (cdc) [ ] offer education and information regarding a wide range of health topics. other health portals that are focused on individual health issues, such as the diabetes center, demonstrate the positive impact of it on health maintenance for diabetes patients. despite evidence of high it use, there is no published evidence about whether the saudi population is using it to obtain health information or make decisions, especially regarding ncds such as diabetes, cardiovascular issues and hypertension. further, no studies have measured saudis' e-health literacy. the study was thus carried out to fill the gap in research in this particular area. illiteracy is still a major problem worldwide, especially as it relates to health and healthcare. many studies have found that almost half of the world's adult population is deficient in reading, writing, and computing skills. roughly % of english-speaking patients have inadequate health literacy skills, resulting in poor healthcare, inadequate medical information, and consequently, lack of treatment. this increases the prevalence of diseases, affects patients' overall health and increases patients' chances of hospitalization [ ] . literacy in e-health involves a variety of skills, from choosing which program to use (internet-based or stand-alone), knowing how to use a search engine, and being able to read and evaluate an article or blog post. furthermore, it is helpful to know how to find and use widgets and utilities available on the web, stay up-to-date on health news, understand medical terminology and jargon, and know how to interpret graphs, charts and statistics. one recently proposed framework for literacy [ ] shows different sets of core skills that can be measured in e-health users and divides literacy into traditional (reading and numerical) literacy, health literacy, science literacy, computer literacy, information literacy and media literacy. science literacy means that a person can understand accounts of scientific experiments in healthcare like what is meant by 'a randomized trial'. health literacy is also needed for a person to interpret health outcomes independently, without professional help. according to another study by chew [ ] , having computing and engineering skills is also a measure of health literacy. nutbeam [ ] defined health literacy from both personal and social aspects and proposed several dimensions such as functional, critical and communicative literacy. paakkari and paakkari [ ] , divided health literacy into theoretical knowledge, practical knowledge, critical thinking, self-awareness and citizenship. ishikawa's et al. [ ] work was an extension of nutbeam's work [ ] and paakkari and paakkari [ ] , recommended that researchers use multiple criteria to evaluate health literacy. similarly, chan et al. [ ] suggested that health literacy should encompass multiple forms of literacy, including traditional, health, science, computer, information and media literacies. many previous studies have explored how health literacy affects patients with chronic illness. low literacy is associated with adverse health outcomes and is common, especially in elderly patients. poor health status is more closely associated with low health literacy than with education, income, ethnic background or any other variables. in addition, patients with low health literacy may become ill or be hospitalized more frequently than patients with high or adequate health literacy [ ] . the relationship between low health literacy and illness has been supported in studies about acute and chronic diseases, which show that health literacy skills have a direct impact on health status outcomes [ ] . the ability to read is, all by itself, a predictor of all-cause mortality and cardiovascular death among the elderly. reading fluency is a more powerful variable than education for examining the association between socioeconomic status and health. chang et al. [ ] posited a relationship between health literacy and two outcome measurements: knowledge and prevention behavior. the most recent study by kim and lee [ ] concluded that diabetes management that is sensitive to health literacy is more effective in reducing hba c levels in patients. all evidence indicates that health literacy can have a strong impact on patient care. the more literate the patient, the better he or she will take care of himself or herself. health literacy is an independent variable in this study. in this study, we describe the development of a saudi e-health literacy scale (sehl) for measuring e-health literacy among saudis suffering from ncds, especially diabetes and cardiovascular diseases. such a scale could be used to assess e-health literacy levels to assist healthcare providers in creating effective e-health interventions for these patients (figure ). we began with a literature review, using pubmed and google scholar to retrieve papers on literacy, health literacy and e-health literacy scales. the search was done from october till june and the list of search terms is listed in table . we eventually pared down the selection from papers to . these papers met our inclusion criteria which were: (i) the topic must be either health literacy or e-health literacy, (ii) the paper must have been cited three or more times and (iii) all papers were included in systematic reviews by ishikawa et al., alsayah and boren [ , , ] . the alsayah et al.'s paper [ ] included all the gold standards in health literacy such as test of functional health literacy in adults ( tofhla), rapid estimates of adult literacy in medicine (realm), single item literacy scales (sils) and newest vital signs (nvs). we also looked at the most recent publications by alsayah et al. [ ] and current papers on e-health literacy such as watkins [ ] . we revisited health literacy skills instruments (hlsi) [ ] and the e-health literacy scale (e-heals) [ ] to understand e-health literacy in depth. we decided that we could not use the e-heals scale because it only looks at literacy on the internet, and because most e-heals work must be accompanied by an it skills test [ , , ] . therefore, the e-heals scale was deemed unsuitable for the saudi nationwide study. we conducted two workshops, in january and may , respectively, to gain a better understanding of the selected studies and make sense of the e-health literacy and health literacy dimensions discussed in them. the process of selecting dimensions, extracting items and scales, and assembling a sehl is illustrated in figure . the workshop attendees were health informatics professionals, health educators and clinicians. a matrix (table ) was created to extract the dimensions used in each paper. as we tried to match the papers with the dimensions, we found that some overlapping concepts were used in similar ways; thus, similar concepts were merged into single dimensions. for example, under 'decision making,' we found four areas: understanding, usefulness, remembering and communication. communication was further subdivided into pronunciation and verbalization, reading comprehension, numeracy, decision making, confidence, health-information seeking, navigation and need for assistance. the dimensions for our sehl scale were finalized as follows: (i) usefulness/understanding, (ii) confidence/needs assistance, (iii) information seeking and (iv) use of technology and media. we then list all the related items and scales, and conducted another workshop to clarify the meanings of the items in each category. during this workshop, we also revisited the reasons behind sehl. we considered the following: how patients sought information, how well they understood it, how useful the information was, how comfortable patients were with new health information, and how they used media and technology for health information. the research group felt that it was important that the logistics of collecting data be straightforward and that the scale be easy to be read. it was presented in a language simple enough to suit the culture and context of our study (table ) . in reviewing the papers for table , we discovered some common literacy dimensions used in both health literacy and e-health literacy assessment. for example, the chinese health literacy scale for diabetes (chlsd), developed by leung et al. [ ] for china's population, adapted other gold-standard scales such tofhla to measure the 'understanding' and 'applying' aspects of literacy. another study by garcia-marcinkiewicz et al. [ ] measured health literacy among patients who had undergone anesthesia, in terms of confidence, usefulness and understanding. garcia-marcinkiewicz used a variety of likert scales, such as 'disagree/agree' and 'never/frequently'. our selected papers also included a study done in taiwan by chang et al. [ ] , which measured media literacy as it related to tobacco and alcohol use. we adapted the media literacy dimension used by chang et al., since patients may receive health information from media content such as youtube, educational videos or webtv. an important study in health literacy by nutbeam, paakkari and paakkari, and ishikawa [ , ] used three literacy dimensions: functional, communicative and critical. functional literacy deals with word recognition and comprehension, communicative literacy deals with how patients understand and communicate information about their disease to others, and critical literacy refers to how patients analyze information and make decisions about their disease. xie [ ] investigated the use of the e-heals scale to measure e-health literacy. e-heals was introduced by skinner based on the selected papers, we chose four literacy dimensions for our sehl scale: (i) use of technology/media: this dimension asks patients how fast they learn to navigate websites and how often they make mistakes when using a web page. follow-up questions measure how often they see chronic illnesses represented in various media on the internet. (ii) information seeking: this dimension explores what information patients find, how and where they find it, and asks their preferences regarding obtaining information about health. many of the items included in this section come from the e-heals scale. (iii) understanding/usefulness: this dimension asks patients how useful the information is to them and whether they have difficulty understanding the information given. (iv) confidence/needs assistance: this dimension measures how confident patients are in filling out forms and whether they need any assistance with reading and understanding the materials given to them at the hospital. our effort to develop sehl is consistent with a recent study by bautista and wee [ ] that suggests researchers should define the operational measure for e-health literacy and measure the validity and reliability of e-health literacy scales. to conduct a large-scale study on health education regarding ncds in saudi arabia and other arabic-speaking countries, we needed to develop an e-health literacy scale suitable for our objectives and context. we were able to aggregate a scale that measures e-health literacy based on four dimensions: decision making, information seeking, confidence, and use of media and technology. we did this by reviewing previous studies in health literacy and e-health literacy and by conducting workshops to propose a new scale suitable for measuring e-health literacy levels among the saudi population. this study may later be extended to other arabic-speaking countries, in which no e-health literacy research has been previously done. there are arabic-speaking countries, which represent a total population of~ million. one study published by giacaman et al. [ ] found a high level of health literacy in israeli-occupied palestinian areas as compared to several arab countries, but no measurements of e-health literacy were conducted. besides the research noting the lack of an available scale, no major work has been done towards measuring e-health literacy at the population level in saudi arabia. the world fact website states that basic literacy (reading and writing) levels in saudi arabia are % (compared to the united states with %). however, e-health literacy-defined as the ability to read, write and understand health information using the internet and other it-is only % in the usa [ ] . no other nation has reported its ehealth literacy at the population level. the development of sehl will contribute to our knowledge of e-health literacy as it relates to ncds in the saudi population. the national study that will be conducted in saudi arabia can help determine the prevalence of health information seeking e-health literacy among patients with ncd. in terms of the public health field, this e-health literacy research can help organization build a better patient education system that would promote prevention of ncds. this study also analyzed literacy dimensions identified in other wellknown scales in alsayah et al. 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ehealth literacy intervention for older adults association of ehealth literacy with cancer information seeking and prior experience with cancer screening association of health literacy with self-management behavior in patients with literacy and diabetes self-management health literacy and nurses' communication with type diabetes patients in primary care settings saudi e-health literacy (sehl) prototype in english decision making (understanding and usefulness) a. how useful is it for you to receive information about chronic illness? key: cord- -rtlygovi authors: martineau, fred p. title: people-centred health systems: building more resilient health systems in the wake of the ebola crisis date: - - journal: int health doi: . /inthealth/ihw sha: doc_id: cord_uid: rtlygovi the – west african ebola outbreak demonstrated the extent to which local social and political dynamics shape health system responses to crises such as epidemics. many post-ebola health system strengthening programmes are framed around a notion of health system ‘resilience’ that focuses on global rather than local priorities and fails to account for key local social dynamics that shape crisis responses. post-crisis health system strengthening efforts require a shift towards a more ‘people-centred’ understanding of resilience that attends to the people, relationships and local contexts that constitute health systems and the practices that produce crisis responses. the - west african ebola outbreak demonstrated the profound and pervasive health, economic, political and social consequences of an inadequate health system. the escalation of the epidemic from a single spill-over event to a global public health crisis was driven to a large extent by people's experiences with government health systems that not only struggled to respond effectively to increased requirements and constraints during the epidemic, but had historically frequently failed to meet basic health needs. in a time of crisis, both these factors combined to undermine the trustworthiness and legitimate authority of government health providers and, by implication, that of national and global epidemic response actors. mistrust in the motives, intentions and capacities of formal response personnel led many to seek support and advice elsewhere, contributing to under-reporting of ebola virus disease cases and the persistence of social practices at risk of transmitting ebola virus. conversely, however, in many instances these alternative social institutions also contributed positivelyoften cruciallyto efforts to reduce transmission and mitigate an epidemic's impact on affected individuals and communities. social dynamics between frontline health workers, health managers and the people they serve are thus key determinants of the effectiveness or otherwise of responses to health crises. for health system strengthening initiatives to genuinely improve how health systems respond to major epidemics, commonly framed as building health system 'resilience', they must therefore understand and address the complex and-crucially-locally constituted relationships and structures that shape how different actors respond to crises in practice. yet currently dominant notions of health system resilience are largely framed in global rather than local terms. how then can local, national and global efforts to improve health system responses better engage with the practice of local health system resilience? originating in disciplines as diverse as mental health and engineering, the relevance of a resilience approach to health system strengthening first achieved prominence in the world health assembly's call to member states to 'strengthen the resilience of the health system and society at large'. almedom and tumwine define resilience as 'the capacity of individuals, families, communities, systems, and institutions to anticipate, withstand and/or judiciously engage with catastrophic events and/or experiences'. this definition usefully highlights the many individuals and groups that contribute to a system's overall resilience, as well as foregrounding existing strengths within systems that may be obscured by blanketlabelling a system as 'fragile', but raises a crucial question: whose judgements count as to whether a particular action is 'judicious'? complex health crises such as an ebola epidemic often produce highly contrasting and competing priorities between different health and non-health actors. the weight and voice afforded to different actors during the response affects whose concerns 'matter' operationally. for example, actions taken at a national or global level to contain ebola virus disease transmission often have paradoxically negative consequences for people's capacity to withstand or engage with other threats to wellbeing at a local level, in particular non-ebola health threats, economic opportunities and social cohesion that are a very real threat to survival. the highly centralised command structure adopted during the - epidemic, advantageous for the rapid delivery of clinical and epidemiological resources at scale, proved far less suitable for identifying and responding to these unintended-but foreseeable-consequences. a failure to appreciate and engage with such local priorities was arguably central to the early ineffectiveness of ebola response efforts. while identifying key properties of health systems that are generally associated with resilience is important in galvanising global support around clearly defined foci, it should not be forgotten that in practice such properties are always enacted locally. system properties are highly context-dependent and emerge from complex, locally specific and dynamic interactions between different health and non-health actors. recognising that flexibility, for example, is important in how a health system responds to a major crisis must be complemented by understanding how people within a particular health system might actually become more flexible in their roles or actions, or its knock-on effects on other important health system properties. the capacities of health workers to reprioritise their clinical activities, of people who are unwell to alter their care-seeking practices, or of previously non-health actors to take on new health roles vary hugely between and within health systems, and depend in particular on power and trust relationships between each actor. interventions and system configurations that enable greater resilience in one context may have the opposite effect in another. identifying generalisably efficacious policy prescriptions for building health system resilience is thus problematic. instead, analyses of how health system resilience is enacted in a particular context at a particular time, through what practices, by which people, shaped by what constraining and enabling factors should be embedded within all stages of health system strengthening. post-ebola health system programming requires a shift in policy thinking towards a more local, relational and practiceoriented understanding of health system resilience. such a shift should start by adapting and applying key insights gained from the recent conceptual shift in health systems and policy research towards 'people-centred' health systemsin particular putting people's voices and needs first, and recognising the central importance of relationships and values in driving system change. what health actors do when faced with a crisis depends on their experiences of the possibilities for, and consequences of, action within their given social, political, economic and moral context. importantly, health actors are not limited to those with formal roles in the health service. in the context of a poorly functioning government health service, actors and institutions outside the government health sector (such as nonformal health practitioners, locally influential leaders, social and occupational networks) may have more influence on how people respond to health crises than actors within the government health sector. the nature of relationships between formal and parallel non-formal health crisis response actors is a key determinant of whether they will operate in concert or in conflict. for health system resilience-building to truly take the 'local' seriously, efforts should therefore focus on understanding and reducing local power disparities, building the trustworthiness of health actors and institutions, developing mechanisms for reconciling rather than eclipsing different actors' priorities and addressing them meaningfully in operational decisions both between and during crises. for example, community surveillance initiatives implemented in the later stages of the ebola outbreak in sierra leone look likely to be continued and strengthened as part of post-ebola resilience-building. such approaches are laudably inclusive in engaging constructively with a variety of health and non-health actors and proved effective in identifying potential ebola cases during the outbreak. yet in the long term, restricting surveillance and system response only to events that are epidemiologically important, while excluding others that are as (or more) important to people locally, will undermine the trustworthiness and perceived value of the programme (and thus its contribution to resilience in practice), as well as being a lost opportunity to identify and tackle more pervasive social and political health determinants. several major post-ebola reports have recognised the critical importance of engaging with sociocultural dimensions during responses to major epidemics and other health crises. , this is no less important in preparing health systems for future crises. one way of achieving this would be to extend calls for greater engagement of anthropologists and social scientists in immediate epidemic responses to their involvement in ongoing health system strengthening efforts. this should not be at the expense of building national and global crisis response capacities, in particular strengthening critical human, material and organisational resources. indeed, the ability to provide effective clinical care is a necessary-but, in isolation, insufficient-component of the trustworthiness of a health system, and those who work in it. nor should the role of social scientists be limited to the delivery of community engagement or social mobilisation activities, but in giving policy-relevant insight into local (and broader) sociocultural and political dynamics that shape health system resilience practices. higher level health system strengthening initiatives must embed explicit localised efforts to build mutual trust, respect and dignity between health actors and the communities they serve alongside initiatives to improve the clinical quality of care. taking the local seriously in health systems will improve health and social outcomes not just in times of crisis but in the everyday functioning of the health system. health-system resilience: reflections on the ebola crisis in western africa key experiences of community engagement and social mobilization in the ebola response infectious disease: tough choices to reduce ebola transmission village responses to ebola virus disease in rural sierra leone. an analytical overview. sierra leone: social mobilisation action consortium what is a resilient health system? lessons from ebola world health assembly. resolution wha . . strengthening national health emergency and disaster management capacities and resilience of health systems. geneva: world health organization resilience to disasters: a paradigm shift from vulnerability to strength trust and the development of health care as a social institution explorations on people centredness in health systems a plan for community event-based surveillance to reduce ebola transmission -sierra leone rapid evaluation of the effectiveness of a community event-based surveillance system for ebola virus disease in sierra leone the neglected dimension of global security: a framework to counter infectious disease crises protecting humanity from future health crises: report of the high-level panel on the global response to health crises. advance unedited copy competing interests: none declared.ethical approval: not required. f. p. martineau key: cord- - v brjf authors: nicholson, felicity title: infectious diseases: the role of the forensic physician date: journal: clinical forensic medicine doi: . / - - - : sha: doc_id: cord_uid: v brjf infections have plagued doctors for centuries, in both the diagnosis of the specific diseases and the identification and subsequent management of the causative agents. there is a constant need for information as new organisms emerge, existing ones develop resistance to current drugs or vaccines, and changes in epidemiology and prevalence occur. in the st century, obtaining this information has never been more important. population migration and the relatively low cost of flying means that unfamiliar infectious diseases may be brought into industrialized countries. an example of this was an outbreak of severe acute respiratory syndrome (sars), which was first recognized in . despite modern technology and a huge input of money, it took months for the agent to be identified, a diagnostic test to be produced, and a strategy for disease reporting and isolation to be established. there is no doubt that other new and fascinating diseases will continue to emerge. infections have plagued doctors for centuries, in both the diagnosis of the specific diseases and the identification and subsequent management of the causative agents. there is a constant need for information as new organisms emerge, existing ones develop resistance to current drugs or vaccines, and changes in epidemiology and prevalence occur. in the st century, obtaining this information has never been more important. population migration and the relatively low cost of flying means that unfamiliar infectious diseases may be brought into industrialized countries. an example of this was an outbreak of severe acute respiratory syndrome (sars), which was first recognized in . despite modern technology and a huge input of money, it took months for the agent to be identified, a diagnostic test to be produced, and a strategy for disease reporting and isolation to be established. there is no doubt that other new and fascinating diseases will continue to emerge. for the forensic physician, dealing with infections presents two main problems. the first problem is managing detainees or police personnel who have contracted a disease and may be infectious or unwell. the second problem is handling assault victims, including police officers, who have potentially been exposed to an infectious disease. the latter can be distressing for those involved, compounded, in part, from an inconsistency of management guidelines, if indeed they exist. with the advent of human rights legislation, increasing pressure is being placed on doctors regarding consent and confidentiality of the detainee. therefore, it is prudent to preempt such situations before the consultation begins by obtaining either written or verbal consent from the detainee to allow certain pieces of information to be disclosed. if the detainee does not agree, then the doctor must decide whether withholding relevant details will endanger the lives or health of those working within custody or others with whom they may have had close contact (whether or not deliberate). consent and confidentiality issues are discussed in detail in chapter . adopting a universal approach with all detainees will decrease the risk to staff of acquiring such diseases and will help to stop unnecessary overreaction and unjustified disclosure of sensitive information. for violent or sexual assault victims, a more open-minded approach is needed (see also chapter ) . if the assailant is known, then it may be possible to make an informed assessment of the risk of certain diseases by ascertaining his or her lifestyle. however, if the assailant is unknown, then it is wise to assume the worst. this chapter highlights the most common infections encountered by the forensic physician. it dispels "urban myths" and provides a sensible approach for achieving effective management. the risk of exposure to infections, particularly blood-borne viruses (bbvs), can be minimized by adopting measures that are considered good practice in the united kingdom, the united states, and australia ( ) ( ) ( ) . forensic physicians or other health care professionals should wash their hands before and after contact with each detainee or victim. police officers should be encouraged to wash their hands after exposure to body fluids or excreta. all staff should wear gloves when exposure to body fluids, mucous membranes, or nonintact skin is likely. gloves should also be worn when cleaning up body fluids or handling clinical waste, including contaminated laundry. single-use gloves should only be used and must conform to the requirements of european standard or equivalent ( ) ( ) ( ) . a synthetic alternative conforming to the same standards should also be available for those who are allergic to latex. all staff should cover any fresh wounds (< hours old), open skin lesions, or breaks in exposed skin with a waterproof dressing. gloves cannot prevent percutaneous injury but may reduce the chance of acquiring a bloodborne viral infection by limiting the volume of blood inoculated. gloves should only be worn when taking blood, providing this does not reduce manual dexterity and therefore increase the risk of accidental percutaneous injury. ideally, a designated person should be allocated to ensure that the clinical room is kept clean and that sharps containers and clinical waste bags are removed regularly. clinical waste must be disposed of in hazard bags and should never be overfilled. after use, the clinical waste should be doublebagged and sealed with hazard tape. the bags should be placed in a designated waste disposal (preferably outside the building) and removed by a professional company. when cells are contaminated with body fluids, a professional cleaning company should be called to attend as soon as possible. until such time, the cell should be deemed "out of action." there is a legal requirement in the united kingdom under the environmental protection act ( ) and the control of substances hazardous to health regulations to dispose of sharps in an approved container. in the united states, the division of health care quality promotion on the centers for disease control and prevention (cdc) web site provides similar guidance. in custody, where sharps containers are transported off site, they must be of an approved type. in the united kingdom, such a requirement is contained within the carriage of dangerous goods (classification, packaging and labelling) and use of transportable pressure receptacles regulations . these measures help to minimize the risk of accidental injury. further precautions include wearing gloves when handling sharps and never bending, breaking, or resheathing needles before disposal. sharps bins should never be overfilled, left on the floor, or placed above the eye level of the smallest member of staff. any bedding that is visibly stained with body fluids should be handled with gloves. there are only three acceptable ways of dealing with contaminated bedding: the bbvs that present the most cross-infection hazard to staff or victims are those associated with persistent viral replication and viremia. these include hbv, hcv, hepatitis d virus (hdv), and hiv. in general, risks of transmission of bbvs arise from the possible exposure to blood or other body fluids. the degree of risk varies with the virus concerned and is discussed under the relevant sections. figure illustrates the immediate management after a percutaneous injury, mucocutaneous exposure, or exposure through contamination of fresh cuts or breaks in the skin. hbv is endemic throughout the world, with populations showing a varying degree of prevalence. approximately two thousand million people have been infected with hbv, with more than million having chronic infection. worldwide, hbv kills about million people each year. with the development of a safe and effective vaccine in , the world health organization (who) recommended that hbv vaccine should be incorporated into national immunization programs by in those countries with a chronic infection rate of % or higher, and into all countries by . although countries had achieved this goal by the end of , the poorest countries-often the ones with the highest prevalence-have been unable to afford it. in particular these include china, the indian subcontinent, and sub-saharan africa. people in the early stages of infection or with chronic carrier status (defined by persistence of hepatitis b surface antigen [hbsag] beyond mo) can transmit infection. in the united kindgom, the overall prevalence of chronic hbv is approx . - . % ( , ) . a detailed breakdown is shown in table . the incubation period is approx weeks to months. as the name suggests, the virus primarily affects the liver. typical symptoms include malaise, anorexia, nausea, mild fever, and abdominal discomfort and may last from days to weeks before the insidious onset of jaundice. joint pain and skin rashes may also occur as a result of immune complex formation. infections in the newborn are usually asymptomatic. * in the united kingdom, written consent from the contact must be sent with the sample, countersigned by the health care practitioner and, preferably, an independent police officer. the majority of patients with acute hbv make a full recovery and develop immunity. after acute infection, approx in patients develop liver failure, which may result in death. chronic infection develops in approx % of neonates, approx % of children, and between and % of adults. neonates and children are usually asymptomatic. adults may have only mild symptoms or may also be asymptomatic. approximately - % of chronically infected individuals (depending on age of acquisition) will develop cirrhosis over a number of years. this may also result in liver failure or other serious complications, including hepatocellular carcinoma, though the latter is rare. the overall mortality rate of hbv is estimated at less than %. a person is deemed infectious if hbsag is detected in the blood. in the acute phase of the illness, this can be as long as months. by definition, if hbsag persists after this time, then the person is deemed a carrier. carriers are usually infectious for life. the degree of infectivity depends on the stage of disease and the markers present table . the major routes include parenteral (e.g., needlestick injuries, bites, unscreened blood transfusions, tattooing, acupuncture, and dental procedures where equipment is inadequately sterilized), mucous membrane exposure (including mouth, eyes, and genital mucous membranes), and contamination of broken skin (especially when < hours old). hbv is an occupational hazard for anyone who may come into contact with blood or bloodstained body fluids through the routes described. saliva alone may transmit hbv. the saliva of some people infected with hbv contains hbv-dna concentrations / - / , of that found in their serum ( ) . this is especially relevant for penetrating bite wounds. infection after exposure to other body fluids (e.g., bile, urine, feces, and cerebrospinal fluid) has never been demonstrated unless the fluids are contaminated with blood. intravenous drug users who share needles or other equipment are also at risk. hbv can also be transmitted through unprotected sexual contact, whether homosexual or heterosexual. the risk is increased if blood is involved. sexual assault victims should be included in this category. evidence has shown that the virus may also be spread among members of a family through close household contact, such as through kissing and sharing toothbrushes, razors, bath towels, etc. ( ) ( ) ( ) . this route of transmission probably applies to institutionalized patients, but there are no available data. studies of prisoners in western countries have shown a higher prevalence of antibodies to hbv and other bbvs than the general population ( ) ( ) ( ) ; the most commonly reported risk factor is intravenous drug use. however, the real frequency of transmission of bbvs in british prisons is unknown owing to the difficulty in compiling reliable data. hbv can be transmitted vertically from mother to baby during the perinatal period. approximately % of babies born to mothers who have either acute or chronic hbv become infected, and most will develop chronic hbv. this has been limited by the administration of hbv vaccine to the neonate. in industrialized countries, all prenatal mothers are screened for hbv. vaccine is given to the neonate ideally within the first hours of birth and at least two more doses are given at designated intervals. the who recommends this as a matter of course for all women in countries where prevalence is high. however, the practicalities of administering a vaccine that has to be stored at the correct temperature in places with limited access to medical care means that there is a significant failure of vaccine uptake and response. in industrialized countries, hbv vaccination is recommended for those who are deemed at risk of acquiring the disease. they include the following: . through occupational exposure. . homosexual/bisexual men. . intravenous drug users. . sexual partners of people with acute or chronic hbv. . family members of people with acute or chronic hbv. . newborn babies whose mothers are infected with hbv. if the mother is hbsag positive, then hepatitis b-specific immunoglobulin (hbig) should be given at the same time as the first dose of vaccine. . institutionalized patients and prisoners. ideally, hbv vaccine should be administered before exposure to the virus. the routine schedule consists of three doses of the vaccine given at , , and months. antibody levels should be checked - weeks after the last dose. if titers are greater than miu/ml, then an adequate response has been achieved. in the united kingdom, this is considered to provide protection for - years. in the united states, if an initial adequate response has been achieved, then no further doses of vaccine are considered necessary. vaccine administration after exposure varies according to the timing of the incident, the degree of risk involved, and whether the individual has already been partly or fully vaccinated. an accelerated schedule when the third dose is given months after the first dose with a booster year later is used to prevent postnatal transmission. where risks are greatest, it may be necessary to use a rapid schedule. the doses are given at , , and - days after presentation, again with a booster dose at - months. this schedule is currently only licensed with engerix b. hbig may also be used either alone or in conjunction with vaccine. the exact dose given is age dependent but must be administered by deep intramuscular injection in a different site from the vaccine. in an adult, this is usually into the gluteus muscle. hbig is given in conjunction with the first dose of vaccine to individuals who are deemed at high risk of acquiring disease and the incident occurred within hours of presentation. it is also used for neonates born to mothers who are hbeag-positive. between and % of adults fail to respond to the routine schedule of vaccine. a further full course of vaccine should be tried before deeming the patients as "nonresponders." such individuals involved in a high-risk exposure should be given two doses of hbig administered mo apart. ideally, the first dose should be given within hours after exposure and no later than weeks after exposure. other measures include minimizing the risk of exposure by adopting the safe working practices outlined in subheading . any potential exposures should be dealt with as soon as possible. in industrialized countries blood, blood products, and organs are routinely screened for hbv. intravenous drug users should be encouraged to be vaccinated and to avoid sharing needles or any other drug paraphernalia (see subheading . . .). for staff or victims in contact with disease, it is wise to have a procedure in place for immediate management and risk evaluation. an example is shown in fig. . although forensic physicians are not expected to administer treatment, it is often helpful to inform persons concerned what to expect. tables and outline treatment protocols as used in the united kingdom. detainees with disease can usually be managed in custody. if the detainee is bleeding, then the cell should be deemed out of action after the detainee has left until it can be professionally cleaned. contaminated bedding should be dealt with as described in subheading . . if the detainee has chronic hbv and is on an antiviral agent (e.g., lamivudine), then the treatment course should be continued, if possible. hcv is endemic in most parts of the world. approximately % ( million) of the world's population is infected with hcv ( ) . for many countries, no reliable prevalence data exist. seroprevalence studies conducted among blood donors have shown that the highest prevalence exists in egypt ( - %). this has been ascribed to contaminated needles used in the treatment of schistosomiasis conducted between the s and the s ( ) . intermediate prevalence ( - %) exists in eastern europe, the mediterranean, the middle east, the indian subcontinent, and parts of africa and asia. in western europe, most of central america, australia, and limited regions in africa, including south africa, the prevalence is low ( . - . %). previously, america was included in the low prevalence group, but a report published in ( ) indicated that almost million americans (i.e., . % of the population) have antibody to hcv, representing either ongoing or previous infection. it also states that hcv accounts for approx % of acute viral hepatitis in america. the lowest prevalence ( . - . %) has been found in the united kingdom and scandinavia. however, within any country, there are certain groups that have a higher chance of carrying hcv. these united kingdom figures are given in table . after an incubation period of - weeks, the acute phase of the disease lasts approx - years. unlike hepatitis a (hav) or hbv, the patient is usually asymptomatic; therefore, the disease is often missed unless the individual has reported a specific exposure and is being monitored. other cases are found by chance, when raised liver enzymes are found on a routine blood test. a "silent phase" follows the acute phase when the virus lies dormant and the liver enzymes are usually normal. this period lasts approx - years. reactivation may then occur. subsequent viral replication damages the hepatocytes, and liver enzymes rise to moderate or high levels. eighty percent of individuals who are hcv antibody-positive are infectious, regardless of the levels of their liver enzymes. approximately % of people develop chronic infection, one-fifth of whom progress to cirrhosis. there is a much stronger association with hepatocellular carcinoma than with hbv. an estimated . - . % of patients with hcv-related cirrhosis develop liver cancer ( ) . less than % of chronic cases resolve spontaneously. approximately % of cases are parenteral (e.g., needle-stick, etc.) ( ) . transmission through the sexual route is not common and only appears to be significant if there is repeated exposure with one or more people infected with hcv. mother-to-baby transmission is considered to be uncommon but has been reported ( ) . theoretically, household spread is also possible through sharing contaminated toothbrushes or razors. because the disease is often silent, there is a need to raise awareness among the general population on how to avoid infection and to encourage high-risk groups to be tested. health care professionals should also be educated to avoid occupationally acquired infection. an example of good practice blood or blood-stained body fluids need to be involved for a risk to occur. saliva alone is not deemed to be a risk. the risk from a single needlestick incident is . % (range - %). contact through a contaminated cut is estimated at %. for penetrating bite injuries, there are no data, but it is only considered a risk if blood is involved. blood or blood-stained body fluids have to be involved in transmission through mucous membrane exposure. this may account for the lower-than-expected prevalence among the gay population. follow the immediate management flow chart, making sure all available information is obtained. inform the designated hospital and/or specialist as soon as possible. if the contact is known and is believed to be immunocompromised and he or she has consented to provide a blood sample, it is important to tell the specialist, because the antibody tests may be spuriously negative. in this instance, a different test should be used (polymerase chain reaction [pcr] , which detects viral rna). the staff member/victim will be asked to provide a baseline sample of blood with further samples at - weeks and again at weeks. if tests are negative at weeks but the risk was deemed high, then follow-up may continue for up to weeks. if any of the follow-up samples is positive, then the original baseline sample will be tested to ascertain whether the infection was acquired through the particular exposure. it is important to emphasize the need for prompt initial attendance and continued monitoring, because treatment is now available. a combination of ribavirin (antiviral agent and interferon a- b) ( ) or the newer pegylated interferons ( ) may be used. this treatment is most effective when it is started early in the course of infection. unless they are severely ill, detainees can be managed in custody. special precautions are only required if they are bleeding. custody staff should wear gloves if contact with blood is likely. contaminated bedding should be handled appropriately, and the cell cleaned professionally after use. this defective transmissible virus was discovered in and requires hbv for its own replication. it has a worldwide distribution in association with hbv, with approx million people infected. the prevalence of hdv is higher in southern italy, the middle east, and parts of africa and south america, occurring in more than % of hbv carriers who are asymptomatic and more than % of those with chronic hbv-related liver disease. despite the high prevalence of hbv in china and south east asia, hdv in these countries is rare. hdv is associated with acute (coinfection) and chronic hepatitis (superinfection) and can exacerbate pre-existing liver damage caused by hbv. the routes of transmission and at-risk groups are the same as for hbv. staff/victims in contact with a putative exposure and detainees with disease should be managed as for hbv. interferon-α (e.g., roferon) can be used to treat patients with chronic hbv and hdv ( ) , although it would not be practical to continue this treatment in the custodial setting. hiv was first identified in , years after the first reports were made to the cdc in atlanta, ga, of an increased incidence of two unusual diseases (kaposi's sarcoma and pneumocystis carinii pneumonia) occurring among the gay population in san francisco. the scale of the virus gradually emerged over the years and by the end of , there were an estimated million people throughout the world living with hiv or acquired immunodeficiency syndrome (aids). more than % of the world's population lives in africa and india. a report by the joint united nations programme on hiv/aids and the who in stated that one in five adults in lesotho, malawi, mozambique, swaziland, zambia, and zimbabwe has hiv or aids. there is also expected to be a sharp rise in cases of hiv in china, papua new guinea, and other countries in asia and the pacific during the next few years. in the united kingdom, by the end of , the cumulative data reported that there were , individuals with hiv, aids (including deaths from aids) reported, though this is likely to be an underestimate ( ) . from these data, the group still considered at greatest risk of acquiring hiv in the united kingdom is homosexual/bisexual men, with , of the cumulative total falling into this category. among intravenous drug users, the overall estimated prevalence is %, but in london the figure is higher at . % ( , ) . in the s, up to % of users in edinburgh and dundee were reported to be hiv positive, but the majority have now died. individuals arriving from africa or the indian subcontinent must also be deemed a risk group because % of the world's total cases occur in these areas. the predominant mode of transmission is through unprotected heterosexual intercourse. the incidence of mother-to-baby transmission has been estimated at % in europe and approx % in africa. the transmission rates among african women are believed to be much higher owing to a combination of more women with end-stage disease with a higher viral load and concomitant placental infection, which renders it more permeable to the virus ( , ) . the use of antiretroviral therapy during pregnancy, together with the advice to avoid breastfeeding, has proven efficacious in reducing both vertical and horizontal transmission among hiv-positive women in the western world. for those in third-world countries, the reality is stark. access to treatment is limited, and there is no realistic substitute for breast milk, which provides a valuable source of antibodies to other life-threatening infections. patients receiving blood transfusions, organs, or blood products where screening is not routinely carried out must also be included. the incubation is estimated at weeks to months after exposure. this depends, to some extent, on the ability of current laboratory tests to detect hiv antibodies or viral antigen. the development of pcr for viral rna has improved sensitivity. during the acute phase of the infection, approx % experience a seroconversion "flu-like" illness. the individual is infectious at this time, because viral antigen (p ) is present in the blood. as antibodies start to form, the viral antigen disappears and the individual enters the latent phase. he or she is noninfectious and remains well for a variable period of time ( - years). development of aids marks the terminal phase of disease. viral antigen reemerges, and the individual is once again infectious. the onset of aids has been considerably delayed with the use of antiretroviral treatment. parenteral transmission included needlestick injuries, bites, unscreened blood transfusions, tattooing, acupuncture, and dental procedures where equipment is inadequately sterilized. risk of transmission is increased with deep penetrating injuries with hollow bore needles that are visibly bloodstained, especially when the device has previously been in the source patient's (contact) artery or vein. other routes include mucous membrane exposure (eyes, mouth, and genital mucous membranes) and contamination of broken skin. the higher the viral load in the contact, the greater the risk of transmission. this is more likely at the terminal stage of infection. hiv is transmitted mainly through blood or other body fluids that are visibly blood stained, with the exception of semen, vaginal fluid, and breast milk. saliva alone is most unlikely to transmit infection. therefore, people who have sustained penetrating bite injuries can be reassured that they are not at risk, providing the contact was not bleeding from the mouth at the time. the risk from a single percutaneous exposure from a hollow bore needle is low, and a single mucocutaneous exposure is even less likely to result in infection. the risk from sexual exposure varies, although it appears that there is a greater risk with receptive anal intercourse compared with receptive vaginal intercourse ( ). high-risk fluids include blood, semen, vaginal fluid, and breast milk. there is little or no risk from saliva, urine, vomit, or feces unless they are visibly bloodstained. other fluids that constitute a theoretical risk include cerebrospinal, peritoneal, pleural, synovial, or pericardial fluid. management in custody of staff/victims in contact with disease includes following the immediate management flow chart (fig. ) and contacting the designated hospital/specialist with details of the exposure. where possible, obtain a blood sample from the contact. regarding hbv and hcv blood samples in the united kingdom, they can only be taken with informed consent. there is no need for the forensic physician to go into details about the meaning of the test, but the contact should be encouraged to attend the genitourinary department (or similar) of the designated hospital to discuss the test results. should the contact refuse to provide a blood sample, then any information about his or her lifestyle, ethnic origin, state of health, etc., may be useful for the specialist to decide whether postexposure prophylaxis (pep) should be given to the victim. where only saliva is involved in a penetrating bite injury, there is every justification to reassure the victim that he or she is not at risk. if in doubt, then always refer. in the united kingdom, the current recommended regime for pep is combivir ( mg of zidovudine twice daily plus mg of lamivudine twice daily) and a protease inhibitor ( mg of nelfanivir twice daily) given for weeks ( ) . it is only given after a significant exposure to a high-risk fluid or any that is visibly bloodstained and the contact is known or is highly likely to be hiv positive. ideally, treatment should be started within an hour after exposure, although it will be considered for up to weeks. it is usually given for weeks, unless the contact is subsequently identified as hiv negative or the "victim" develops tolerance or toxicity occurs. weekly examinations of the "victim" should occur during treatment to improve adherence, monitor drug toxicity, and deal with other concerns. other useful information that may influence the decision whether to treat with the standard regimen or use alternative drugs includes interaction with other medications that the "victim" may be taking (e.g., phenytoin or antibiotics) or if the contact has been on antiretroviral therapy or if the "victim" is pregnant. during the second or third trimester, only combivir would be used, because there is limited experience with protease inhibitors. no data exist regarding the efficacy of pep beyond occupational exposure ( ) . pep is not considered for exposure to low-or no-risk fluids through any route or where the source is unknown (e.g., a discarded needle). despite the appropriate use and timing of pep, there have been reports of failure ( , ) . unless they are severely ill, detainees can be kept in custody. every effort should be made to continue any treatment they may be receiving. apply universal precautions when dealing with the detainee, and ensure that contaminated cells and/or bedding are managed appropriately. cases of this highly infectious disease occur throughout the year but are more frequent in winter and early spring. this seasonal endemicity is blurring with global warming. in the united kingdom, the highest prevalence occurs in the -to -years age group. ninety percent of the population over the age of is immune ( ) . a similar prevalence has been reported in other parts of western europe and the united states. in south east asia, varicella is mainly a disease of adulthood ( ) . therefore, people born in these countries who have moved to the united kingdom are more likely to be susceptible to chicken pox. there is a strong correlation between a history of chicken pox and serological immunity ( - %). most adults born and living in industrialized countries with an uncertain or negative history of chicken pox are also seropositive ( - %). in march , a live-attenuated vaccine was licensed for use in the united states and a policy for vaccinating children and susceptible health care personnel was introduced. in summer , in the united kingdom, glaxosmithkline launched a live-attenuated vaccine called varilrix. in december , the uk department of health, following advice from the joint committee on vaccination and immunisation recommended that the vaccine be given for nonimmune health care workers who are likely to have direct contact with individuals with chicken pox. any health care worker with no previous history of chicken pox should be screened for immunity, and if no antibodies are found, then they should receive two doses of vaccine - weeks apart. the vaccine is not currently recommended for children and should not be given during pregnancy. following an incubation period of - days (this may be shorter in the immunocompromised), there is usually a prodromal "flu-like" illness before the onset of the rash. this coryzal phase is more likely in adults. the lesions typically appear in crops, rapidly progressing from red papules through vesicles to open sores that crust over and separate by days. the distribution of the rash is centripetal (i.e., more over the trunk and face than on the limbs). this is the converse of small pox. in adults, the disease is often more severe, with lesions involving the scalp and mucous membranes of the oropharynx. in children, the disease is often mild, unless they are immunocompromised, so they are unlikely to experience complications. in adults (defined as yr or older), the picture is rather different ( ) . secondary bacterial infection is common but rarely serious. there is an increased likelihood of permanent scarring. hemorrhagic chicken pox typically occurs on the second or third day of the rash. usually, this is limited to bleeding into the skin, but lifethreatening melena, epistaxis, or hematuria can occur. varicella pneumonia ranges from patchy lung consolidation to overt pneumonitis and occurs in in cases ( ) . it can occur in previously healthy individuals (particularly adults), but the risk is increased in those who smoke. immunocompromised people are at the greatest risk of developing this complication. it runs a fulminating course and is the most common cause of varicella-associated death. fibrosis and permanent respiratory impairment may occur in those who survive. any suspicion of lung involvement is an indication for immediate treatment, and any detainee or staff member should be sent to hospital. involvement of the central nervous system includes several conditions, including meningitis, guillain-barre, and encephalitis. the latter is more common in the immunocompromised and can be fatal. this is taken as days before the first lesions appear to the end of new vesicle formation and the last vesicle has crusted over. this typically is - days after onset but may last up to days. the primary route is through direct contact with open lesions of chicken pox. however, it is also spread through aerosol or droplets from the respiratory tract. chicken pox may also be acquired through contact with open lesions of shingles (varicella zoster), but this is less likely because shingles is less infectious than chicken pox. nonimmune individuals are at risk of acquiring disease. approximately % of the adult population born in the united kingdom and less than % of adults in the united states fall into this category. therefore, it is more likely that if chicken pox is encountered in the custodial setting, it will involve people born outside the united kingdom (particularly south east asia) or individuals who are immunocompromised and have lost immunity. nonimmune pregnant women are at risk of developing complications. pneumonia can occur in up to % of pregnant women with chicken pox, and the severity is increased in later gestation ( ) . they can also transmit infection to the unborn baby ( ) . if infection is acquired in the first weeks, there is a less than % chance of it leading to congenital varicella syndrome. infection in the last trimester can lead to neonatal varicella, unless more than days elapse between onset of maternal rash and delivery when antibodies have time to cross the placenta leading to either mild or inapparent infection in the newborn. in this situation, varicella immunoglobulin (vzig) should be administered to the baby as soon as possible after birth ( ). staff with chicken pox should stay off work until the end of the infective period (approx - days). those in contact with disease who are known to be nonimmune or who have no history of disease should contact the designated occupational health physician. detainees with the disease should not be kept in custody if at all possible (especially pregnant women). if this is unavoidable, then nonimmune or immunocompromised staff should avoid entering the cell or having close contact with the detainee. nonimmune, immunocompromised, or pregnant individuals exposed to chickenpox should seek expert medical advice regarding the administration of vzig. aciclovir (or similar antiviral agent) should be given as soon as possible to people who are immunocompromised with chicken pox. it should also be considered for anyone over years old because they are more likely to develop complications. anyone suspected of severe complications should be sent straight to the hospital. after chicken pox, the virus lies dormant in the dorsal root or cranial nerve ganglia but may re-emerge and typically involves one dermatome ( ) . the site of involvement depends on the sensory ganglion initially involved. shingles is more common in individuals over the age of years, except in the immunocompromised, when attacks can occur at an earlier age. the latter are also more susceptible to secondary attacks and involvement of more than one dermatome. bilateral zoster is even rarer but is not associated with a higher mortality. in the united kingdom, there is an estimated incidence of . - . per -person years ( ). there may be a prodromal period of paraesthesia and burning or shooting pains in the involved segment. this is usually followed by the appearance of a band of vesicles. rarely, the vesicles fail to appear and only pain is experienced. this is known as zoster sine herpete. in individuals who are immuno-compromised, disease may be prolonged and dissemination may occur but is rarely fatal. shingles in pregnancy is usually mild. the fetus is only affected if viremia occurs before maternal antibody has had time to cross the placenta. the most common complication of shingles is postherpetic neuralgia, occurring in approx % of cases. it is defined as pain lasting more than days from rash onset ( ) . it is more frequent in people over years and can lead to depression. it is rare in children, including those who are immunocompromised. infection of the brain includes encephalitis, involvement of motor neurones leading to ptosis, paralysis of the hand, facial palsy, or contralateral hemiparesis. involvement of the oculomotor division of the trigeminal ganglion can cause serious eye problems, including corneal scarring. shingles is far less infectious than chicken pox and is only considered to be infectious up to days after lesions appear. shingles is only infectious after prolonged contact with lesions. unlike chickenpox, airborne transmission is not a risk. individuals who are immunocompromised may reactivate the dormant virus and develop shingles. people who have not had primary varicella are at risk of developing chickenpox after prolonged direct contact with shingles. despite popular belief, it is untrue that people who are immunocompetent who have had chicken pox develop shingles when in contact with either chicken pox or shingles. such occurrences are merely coincidental, unless immunity is lowered. staff with shingles should stay off work until the lesions are healed, unless they can be covered. staff who have had chickenpox are immune (including pregnant women) and are therefore not at risk. if they are nonimmune (usually accepted as those without a history of chicken pox), they should avoid prolonged contact with detainees with shingles. pregnant nonimmune women should avoid contact altogether. detainees with the disease may be kept in custody, and any exposed lesions should be covered. it is well documented that prompt treatment attenuates the severity of the disease, reduces the duration of viral shedding, hastens lesion healing, and reduces the severity and duration of pain. it also reduces the likelihood of developing postherpetic neuralgia ( ) . prompt treatment with famciclovir (e.g., mg three times a day for days) should be initiated if the onset is d ays or less. it should also be considered after this time if the detainee is over age years. pregnant detainees with shingles can be reassured that there is minimal risk for both the mother and the unborn child. expert advice should be given before initiating treatment for the mother. this tiny parasitic mite (sarcoptes scabiei) has infested humans for more than years. experts estimate that in excess of million cases occur worldwide each year. the female mite burrows into the skin, especially around the hands, feet, and male genitalia, in approx . min. eggs are laid and hatch into larvae that travel to the skin surface as newly developed mites. the mite causes intense itching, which is often worse at night and is aggravated by heat and moisture. the irritation spreads outside the original point of infection resulting from an allergic reaction to mite feces. this irritation may persist for approx weeks after treatment but can be alleviated by antihistamines. crusted scabies is a far more severe form of the disease. large areas of the body may be involved. the crusts hide thousands of live mites and eggs, making them difficult to treat. this so-called norwegian scabies is more common in the elderly or the immunocompromised, especially those with hiv. after a primary exposure, it takes approx - weeks before the onset of itching. however, further exposures reduce the incubation time to approx - days. without treatment, the period of infectivity is assumed to be indefinite. with treatment, the person should be considered infectious until the mites and eggs are destroyed, usually - days. crusted scabies is highly infectious. because transmission is through direct skin-to-skin contact with an infected individual, gloves should be worn when dealing with individuals suspected of infestation. usually prolonged contact is needed, unless the person has crusted scabies, where transmission occurs more easily. the risk of transmission is much greater in households were repeated or prolonged contact is likely. because mites can survive in bedding or clothing for up to hour, gloves should also be worn when handling these items. bedding should be treated using one of the methods in subheading . . professional cleaning of the cell is only warranted in cases of crusted scabies. the preferred treatment for scabies is either permethrin cream ( %) or aqueous malathion ( . %) ( ) . either treatment has to be applied to the whole body and should be left on for at least hours in the case of permethrin and hours for malathion before washing off. lindane is no longer considered the treatment of choice, because there may be complications in pregnancy ( ) . treatment in custody may not be practical but should be considered when the detainee is believed to have norwegian scabies. like scabies, head lice occur worldwide and are found in the hair close to the scalp. the eggs, or nits, cling to the hair and are difficult to remove, but they are not harmful. if you see nits, then you can be sure that lice are also present. the latter are best seen when the hair is wet. the lice bite the scalp and suck blood, causing intense irritation and itching. head lice can only be passed from direct hair-to-hair contact. it is only necessary to wear gloves when examining the head for whatever reason. the cell does not need to be cleaned after use, because the lice live on or near skin. bedding may be contaminated with shed skin, so should be handled with gloves and laundered or incinerated. the presence of live lice is an indication for treatment by either physical removal with a comb or the application of an insecticide. the latter may be more practical in custody. treatment using . % aqueous malathion should be applied to dry hair and washed off after hours. the hair should then be shampooed as normal. crabs or body lice are more commonly found in the pubic, axillary, chest, and leg hair. however, eyelashes and eyebrows may also be involved. they are associated with people who do not bath or change clothes regularly. the person usually complains of intense itching or irritation. the main route is from person to person by direct contact, but eggs can stick to fibers, so clothing and bedding should be handled with care (see subheading . . .). staff should always wear gloves if they are likely to come into contact with any hirsute body part. clothing or bedding should be handled with gloves and either laundered or incinerated. treatment of a detainee in custody is good in theory but probably impractical because the whole body has to be treated. fleas lay eggs on floors, carpets, and bedding. in the united kingdom, most flea bites come from cats or dogs. the eggs and larvae fleas can survive for months and are reactivated in response to animal or human activity. because animal fleas jump off humans after biting, most detainees with flea bites will not have fleas, unless they are human fleas. treatment is only necessary if fleas are seen. after use, the cell should be vacuumed and cleaned with a proprietary insecticide. any bedding should be removed wearing gloves, bagged, and either laundered or incinerated. bedbugs live and lay eggs on walls, floors, furniture, and bedding. if you look carefully, fecal tracks may be seen on hard surfaces. if they are present for long enough, they emit a distinct odor. bedbugs are rarely found on the person but may be brought in on clothing or other personal effects. bedbugs bite at night and can cause sleep disturbance. the detainee does not need to be treated, but the cell should deemed out of use until it can be vacuumed and professionally cleaned with an insecticide solution. any bedding or clothing should be handled with gloves and disposed of as appropriate. staphylococcus aureus is commonly carried on the skin or in the nose of healthy people. approximately - % of the population is colonized with the bacteria but remain well ( ) . from time to time, the bacteria cause minor skin infections that usually do not require antibiotic treatment. however, more serious problems can occur (e.g., infection of surgical wounds, drug injection sites, osteomyelitis, pneumonia, or septicemia). during the last years, the bacteria have become increasingly resistant to penicillin-based antibiotics ( ) , and in the last years, they have become resistant to an increasing number of alternative antibiotics. these multiresistant bacteria are known as methicillinresistant s. aureus (mrsa). mrsa is prevalent worldwide. like nonresistant staphylococci, it may remain undetected as a reservoir in colonized individuals but can also produce clinical disease. it is more common in individuals who are elderly, debilitated, or immunocompromised or those with open wounds. clusters of skin infections with mrsa have been reported among injecting drug users (idus) since in america ( , ) , and more recently, similar strains have been found in the united kingdom in idus in the community ( ) . this may have particular relevance for the forensic physician when dealing with idus sores. people who are immunocompetent rarely get mrsa and should not be considered at risk. the bacteria are usually spread via the hands of staff after contact with colonized or infected detainees or devices, items (e.g., bedding, towels, and soiled dressings), or environmental surfaces that have been contaminated with mrsa-containing body fluids. with either known or suspected cases (consider all abscesses/ulcers of idus as infectious), standard precautions should be applied. staff should wear gloves when touching mucous membranes, nonintact skin, blood or other body fluids, or any items that could be contaminated. they should also be encouraged to their wash hands with an antimicrobial agent regardless of whether gloves have been worn. after use, gloves should be disposed of in a yellow hazard bag and not allowed to touch surfaces. masks and gowns should only be worn when conducting procedures that generate aerosols of blood or other body fluids. because this is an unlikely scenario in the custodial setting, masks and gowns should not be necessary. gloves should be worn when handling bedding or clothing, and all items should be disposed of appropriately. any open wounds should be covered as soon as possible. the cell should be cleaned professionally after use if there is any risk that it has been contaminated. during the last decade, there has been an increasing awareness of the bacterial flora colonizing injection sites that may potentially lead to life-threatening infection ( ) . in , a sudden increase in needle abscesses caused by a clonal strain of group a streptococcus was reported among hospitalized idus in berne, switzerland ( ) . a recent uk study showed that the predominant isolate is s. aureus, with streptococcus species forming just under one-fifth ( % β-hemolytic streptococci) ( ) . there have also been reports of both nonsporing and sporing anerobes (e.g., bacteroides and clostridia species, including clostridia botulinum) ( , ) . in particular, in , laboratories in glasgow were reporting isolates of clostridium novyi among idus with serious unexplained illness. by june , , a total of cases ( definite and probable) had been reported. a definite case was defined as an idu with both severe local and systemic inflammatory reactions. a probable case was defined as an idu who presented to the hospital with an abscess or other significant inflammation at an injecting site and had either a severe inflammatory process at or around an injection site or a severe systemic reaction with multiorgan failure and a high white cell count ( ) . in the united kingdom, the presence of c. botulinum in infected injection sites is a relatively new phenomenon. until the end of , there were no cases reported to the public health leadership society. since then, the number has increased, with a total of cases in the united kingdom and ireland being reported since the beginning of . it is believed that these cases are associated with contaminated batches of heroin. simultaneous injection of cocaine increases the risk by encouraging anerobic conditions. anerobic flora in wounds may have serious consequences for the detainee, but the risk of transmission to staff is virtually nonexistent. staff should be reminded to wear gloves when coming into contact with detainees with infected skin sites exuding pus or serum and that any old dressings found in the cell should be disposed of into the yellow bag marked "clinical waste" in the medical room. likewise, any bedding should be bagged and laundered or incinerated after use. the cell should be deemed out of use and professionally cleaned after the detainee has gone. the health care professional managing the detainee should clean and dress open wounds as soon as possible to prevent the spread of infection. it may also be appropriate to start a course of antibiotics if there is abscess formation or signs of cellulites and/or the detainee is systemically unwell. however, infections can often be low grade because the skin, venous, and lymphatic systems have been damaged by repeated penetration of the skin. in these cases, signs include lymphedema, swollen lymph glands, and darkly pigmented skin over the area. fever may or may not be present, but septicemia is uncommon unless the individual is immunocompromised (e.g., hiv positive). co-amoxiclav is the preferred treatment of choice because it covers the majority of staphylococci, streptococci, and anerobes (the dose depends on the degree of infection). necrotizing fasciitis and septic thrombophlebitis are rare but life-threatening complications of intravenous drug use. any detainee suspected of either of these needs hospital treatment. advice about harm reduction should also be given. this includes encouraging drug users to smoke rather than inject or at least to advise them to avoid injecting into muscle or skin. although most idus are aware of the risk of sharing needles, they may not realize that sharing any drug paraphernalia could be hazardous. advice should be given to use the minimum amount of citric acid to dissolve the heroin because the acid can damage the tissue under the skin, allowing bacteria to flourish. drugs should be injected at different sites using fresh works for each injection. this is particularly important when "speedballing" because crack cocaine creates an anerobic environment. medical help should be requested if any injection site become painful and swollen or shows signs of pus collecting under the skin. because intravenous drug users are at increased risk of acquiring hbv and hav, they should be informed that vaccination against both diseases is advisable. another serious but relatively rare problem is the risk from broken needles in veins. embolization can take anywhere from hours to days or even longer if it is not removed. complications may include endocarditis, pericarditis, or pulmonary abscesses ( , ) . idus should be advised to seek medical help as soon as possible, and should such a case present in custody, then send the detainee straight to the hospital. the forensic physician may encounter bites in the following four circumstances: a detailed forensic examination of bites is given in chapter . with any bite that has penetrated the skin, the goals of therapy are to minimize soft tissue deformity and to prevent or treat infection. in the united kingdom and the united states, dog bites represent approximately three-quarters of all bites presenting to accident and emergency departments ( ) . a single dog bite can produce up to psi of crush force in addition to the torsional forces as the dog shakes its head. this can result in massive tissue damage. human bites may cause classical bites or puncture wounds (e.g., impact of fists on teeth) resulting in crush injuries. an estimated - % of dog bites and - % of human bites lead to infection. compare this with an estimated - % of nonbite wounds managed in accident and emergency departments. the risk of infection is increased with puncture wounds, hand injuries, full-thickness wounds, wounds requiring debridement, and those involving joints, tendons, ligaments or fractures. comorbid medical conditions, such as diabetes, asplenia, chronic edema of the area, liver dysfunction, the presence of a prosthetic valve or joint, and an immunocompromised state may also increase the risk of infection. infection may spread beyond the initial site, leading to septic arthritis, osteomyelitis, endocarditis, peritonitis, septicemia, and meningitis. inflammation of the tendons or synovial lining of joints may also occur. if enough force is used, bones may be fractured or the wounds may be permanently disfiguring. assessment regarding whether hospital treatment is necessary should be made as soon as possible. always refer if the wound is bleeding heavily or fails to stop when pressure is applied. penetrating bites involving arteries, nerves, muscles, tendons, the hands, or feet, resulting in a moderate to serious facial wound, or crush injuries, also require immediate referral. if management within custody is appropriate, ask about current tetanus vaccine status, hbv vaccination status, and known allergies to antibiotics. wounds that have breached the skin should be irrigated with . % (isotonic) sodium chloride or ringer's lactate solution instead of antiseptics, because the latter may delay wound healing. a full forensic documentation of the bite should be made as detailed in chapter . note if there are clinical signs of infection, such as erythema, edema, cellulitis, purulent discharge, or regional lymphadenopathy. cover the wound with a sterile, nonadhesive dressing. wound closure is not generally recommended because data suggest that it may increase the risk of infection. this is particularly relevant for nonfacial wounds, deep puncture wounds, bites to the hand, clinically infected wounds, and wounds occurring more than - hours before presentation. head and neck wounds in cosmetically important areas may be closed if less than hours old and not obviously infected. • dog bites-pasteurella canis, pasteurella multocida, s. aureus, other staphylococci, streptococcus species, eikenella corrodens, corynebacterium species, and anerobes, including bacteroides fragilis and clostridium tetani • human bites-streptococcus species, s. aureus, e. corrodens, and anerobes, including bacteroides (often penicillin resistant), peptostreptococci species, and c. tetani. tuberculosis (tb) and syphilis may also be transmitted. • dog bites-outside of the united kingdom, australia, and new zealand, rabies should be considered. in the united states, domestic dogs are mostly vaccinated against rabies ( ) , and police dogs have to be vaccinated, so the most common source is from racoons, skunks, and bats. • human bites-hbv, hbc, hiv, and herpes simplex. antibiotics are not generally needed if the wound is more than days old and there is no sign of infection or in superficial noninfected wounds evaluated early that can be left open to heal by secondary intention in compliant people with no significant comorbidity ( ) . antibiotics should be considered with high-risk wounds that involve the hands, feet, face, tendons, ligaments, joints, or suspected fractures or for any penetrating bite injury in a person with diabetes, asplenia, or cirrhosis or who is immunosuppressed. coamoxiclav (amoxycillin and clavulanic acid) is the first-line treatment for mild-moderate dog or human bites resulting in infections managed in primary care. for adults, the recommended dose is / mg three times daily and for children the recommended does is mg/kg three times daily (based on amoxycillin component). treatment should be continued for - days. it is also the first-line drug for prophylaxis when the same dose regimen should be prescribed for - days. if the individual is known or suspected to be allergic to penicillin, a tetracycline (e.g., doxycycline mg twice daily) and metronidazole ( mg three times daily) or an aminoglycoside (e.g., erythromycin) and metronidazole can be used. in the united kingdom, doxycycline use is restricted to those older than years and in the united states to those older than years old. specialist advice should be sought for pregnant women. anyone with severe infection or who is clinically unwell should be referred to the hospital. tetanus vaccine should be given if the primary course or last booster was more than years ago. human tetanus immunoglobulin should be considered for tetanus-prone wounds (e.g., soil contamination, puncture wounds, or signs of devitalized tissue) or for wounds sustained more than hours old. if the person has never been immunized or is unsure of his or her tetanus status, a full three-dose course, spaced at least month apart, should be given. penetrating bite wounds that involve only saliva may present a risk of hbv if the perpetrator belongs to a high-risk group. for management, see subheadings . . . and . . . hcv and hiv are only a risk if blood is involved. the relevant management is dealt with in subheadings . . . and . . . respiratory tract infections are common, usually mild, and self-limiting, although they may require symptomatic treatment with paracetamol or a nonsteroidal antiinflammatory. these include the common cold ( % rhinoviruses and % coronaviruses), adenoviruses, influenza, parainfluenza, and, during the summer and early autumn, enteroviruses. special attention should be given to detainees with asthma or the who are immunocompromised, because infection in these people may be more serious particularly if the lower respiratory tract is involved. the following section includes respiratory pathogens of special note because they may pose a risk to both the detainee and/or staff who come into close contact. there are five serogroups of neisseria meningitidis: a, b, c, w , and y. the prevalence of the different types varies from country to country. there is currently no available vaccine against type b, but three other vaccines (a+c, c, and acwy) are available. overall, % of the uk population carry n. meningitidis ( % in the - age group) ( ) . in the united kingdom, most cases of meningitis are sporadic, with less than % occurring as clusters (outbreaks) amongst school children. between and , % of cases were group b, % were group c, and w and a accounted for %. there is a seasonal variation, with a high level of cases in winter and a low level in the summer. the greatest risk group are the under year olds, with a peak incidence under year old. a secondary peak occurs in the -to -year-old age group. in sub-saharan africa, the disease is more prevalent in the dry season, but in many countries, there is background endemicity year-round. the most prevalent serogroup is a. routine vaccination against group c was introduced in the united kingdom november for everybody up to the age of years old and to all firstyear university students. this has since been extended to include everyone under the age of years old. as a result of the introduction of the vaccination program, there has been a % reduction of group c cases in those younger than under years and an % reduction in those under year old ( , ) . an outbreak of serogroup w meningitis occurred among pilgrims on the hajj in . cases were reported from many countries, including the united kingdom. in the united kingdom, there is now an official requirement to be vaccinated with the quadrivalent vaccine (acwy vax) before going on a pilgrimage (hajj or umra), but illegal immigrants who have not been vaccinated may enter the country ( ). after an incubation period of - days ( , ) , disease onset may be either insidious with mild prodromal symptoms or florid. early symptoms and signs include malaise, fever, and vomiting. sever headache, neck stiffness, photophobia, drowsiness, and a rash may develop. the rash may be petechial or purpuric and characteristically does not blanche under pressure. meningitis in infants is more likely to be insidious in onset and lack the classical signs. in approx - % of cases, septicemia is the predominant feature. even with prompt antibiotic treatment, the case fatality rate is - % in meningitis and - % in those with septicemia. ( ). a person should be considered infectious until the bacteria are no longer present in nasal discharge. with treatment, this is usually approx hour. the disease is spread through infected droplets or direct contact from carriers or those who are clinically ill. it requires prolonged and close contact, so it is a greater risk for people who share accommodation and utensils and kiss. it must also be remembered that unprotected mouth-to-mouth resuscitation can also transmit disease. it is not possible to tell if a detainee is a carrier. nevertheless, the risk of acquiring infection even from an infected and sick individual is low, unless the individual has carried out mouth-to-mouth resuscitation. any staff member who believes he or she has been placed at risk should report to the occupational health department (or equivalent) or the nearest emergency department at the earliest opportunity for vaccination. if the detainee has performed mouth-to-mouth resuscitation, prophylactic antibiotics should be given before receiving vaccination. rifampicin, ciprofloxacin, and ceftriaxone can be used; however, ciprofloxacin has numerous advantages ( ) . only a single dose of mg (adults and children older than years) is needed and has fewer side effects and contraindications than rifampicin. ceftriaxone has to be given by injection and is therefore best avoided in the custodial setting. if the staff member is pregnant, advice should be sought from a consultant obstetrician, because ciprofloxacin is not recommended ( ) . for anyone dealing regularly with illegal immigrants (especially from the middle east or sub-saharan africa) (e.g., immigration services, custody staff at designated stations, medical personnel, and interpreters), should consider being vaccinated with acwy vax. a single injection provides protection for years. detainees suspected of disease should be sent directly to the hospital. human tb is caused by infection with mycobacterium tuberculosis, mycobacterium bovis, or mycobacterium africanum. it is a notifiable disease under legislation specific to individual countries; for example, in the united kingdom, this comes under the public health (control of disease) act of . in , the who declared tb to be a global emergency, with an estimated - million new cases and million deaths occurring each year, the majority of which were in asia and africa. however, these statistics are likely to be an underestimate because they depend on the accuracy of reporting, and in poorer countries, the surveillance systems are often inadequate because of lack of funds. even in the united kingdom, there has been an inconsistency of reporting particularly where an individual has concomitant infection with hiv. some physicians found themselves caught in a dilemma of confidentiality until , when the codes of practice were updated to encourage reporting with patient consent ( ) . with the advent of rapid identification tests and treatment and the use of bacillus calmette-guérin (bcg) vaccination for prevention, tb declined during the first half of the th century in the united kingdom. however, since the early s, numbers have slowly increased, with some cases reported in ( ) . in , % of reported cases were from people born outside the united kingdom and % were associated with hiv infection ( , ) . london has been identified as an area with a significant problem. this has been attributed to its highly mobile population, the variety of ethnic groups, a high prevalence of hiv, and the emergence of drug-resistant strains ( . % in ) (phls, unpublished data-mycobnet). a similar picture was initially found in the united states, when there was a reversal of a long-standing downward trend in . however, between and , the number of cases increased from , to , ( ) . there were also serious outbreaks of multidrug-resistant tb (mdr-tb) in hospitals in new york city and miami ( ) . factors pertinent to the overall upswing included the emergence of hiv, the increasing numbers of immigrants from countries with a high prevalence of tb, and perhaps more significantly, stopping categorical federal funding for control activities in . the latter led to a failure of the public health infrastructure for tb control. since , the trend has reversed as the cdc transferred most of its funds to tb surveillance and treatment program in states and large cities. from to , the annual decline averaged by . % ( ) , but the following year this was reduced to %, indicating that there was no room for complacency. the who has been proactive and is redirecting funding to those countries most in need. in october , a global partnership called stop tb was launched to coordinate every aspect of tb control, and by , the partnership had more than member states. a target was set to detect at least % of infectious cases by . the acquisition of tb infection is not necessarily followed by disease because the infection may heal spontaneously. it may take weeks or months before disease becomes apparent, or infection may remain dormant for years before reactivation in later life especially if the person becomes debilitated or immunocompromised. contrary to popular belief, the majority of cases of tb in people who are immunocompetent pass unnoticed. of the reported cases, % involve the lung, whereas nonrespiratory (e.g., bone, heart, kidney, and brain) or dissemination (miliary tb) are more common in immigrant ethnic groups and individuals who are immunocompromised ( ) . they are also more likely to develop resistant strains. in the general population, there is an estimated % lifetime risk of tb infection progressing to disease ( ) . there has been an increase in the number of cases of tb associated with hiv owing to either new infection or reactivation. tb infection is more likely to progress to active tb in hiv-positive individuals, with a greater than % lifetime risk ( ) . tb can also lead to a worsening of hiv with an increase in viral load ( ) . therefore, the need for early diagnosis is paramount, but it can be more difficult because pulmonary tb may present with nonspecific features (e.g., bilateral, unilateral, or lower lobe shadowing) ( ). after an incubation period of - weeks, symptoms may develop (see table ). the main route is airborne through infected droplets, but prolonged or close contact is needed. nonrespiratory disease is not considered a risk unless the mycobacterium is aerosolized under exceptional circumstances (e.g., during surgery) or there are open abscesses. a person is considered infectious as long as viable bacilli are found in induced sputum. untreated or incompletely treated people may be intermittently sputum positive for years. after weeks of appropriate treatment, the individual is usually considered as noninfectious. this period is often extended for treatment of mdr-tb or for those with concomitant hiv. patient compliance also plays an important factor. the risk of infection is directly proportional to the degree of exposure. more severe disease occurs in individuals who are malnourished, immunocompromised (e.g., hiv), and substance misusers. people who are immunocompromised are at special risk of mdr-tb or mycobacterium avium intracellulare (mai). staff with disease should stay off work until the treatment course is complete and serial sputum samples no longer contain bacilli. staff in contact with disease who have been vaccinated with bcg are at low risk of acquiring disease but should minimize their time spent in the cell. those who have not received bcg or who are immunocompromised should avoid contact with the detainee wherever possible. detainees with mai do not pose a risk to a staff member, unless the latter is immunocompromised. any staff member who is pregnant, regardless of bcg status or type of tb, should avoid contact. anyone performing mouth-to-mouth resuscitation with a person with untreated or suspected pulmonary tb should be regarded as a household contact and should report to occupational health or their physician if no other route exists. they should also be educated regarding the symptoms of tb. anyone who is likely to come into repeated contact with individuals at risk of tb should receive bcg (if he or she has not already done so), regardless of age, even though there is evidence to suggest that bcg administered in adult life is less effective. this does not apply to individuals who are immunocompromised or pregnant women. in the latter case, vaccination should preferably be deferred until after delivery. detainees with disease (whether suspected or diagnosed) who have not been treated or treatment is incomplete should be kept in custody for the minimum time possible. individuals with tb who are immunocompromised are usually too ill to be detained; if they are, they should be considered at greater risk of transmitting disease to staff. any detainee with disease should be encouraged to cover his or her mouth and nose when coughing and sneezing. staff should wear gloves when in contact with the detainee and when handling clothing and bedding. any bedding should be bagged after use and laundered or incinerated. the cell should be deemed out of action until it has been ventilated and professionally decontaminated, although there is no hard evidence to support that there is a risk of transmission from this route ( ). on march , , the who issued a global warning to health authorities about a new atypical pneumonia called sars. the earliest case was believed to have originated in the guandong province of china on november , . the causative agent was identified as a new corona virus-sars-cov ( , ) . by the end of june , cases had been reported from different countries, with a total of deaths. approximately % of cases occurred in china (including hong kong, taiwan, and macao). the case fatality rate varied from less than % in people younger than years, % in persons aged - years, % in those aged - years, and more than % in persons years or older. on july , , the who reported that the last human chain of transmission of sars had been broken and lifted the ban from all countries. however, it warned that everyone should remain vigilant, because a resurgence of sars is possible. their warning was well given because in december , a new case of sars was detected in china. at the time of this writing, three more cases have been identified. knowledge about the epidemiology and ecology of sars-cov and the disease remains limited; however, the experience gained from the previous outbreak enabled the disease to be contained rapidly, which is reflected in the few cases reported since december . there is still no specific treatment or preventative vaccine that has been developed. the incubation period is short, approx - days (maximum days), and, despite the media frenzy surrounding the initial outbreak, sars is less infectious than influenza. the following clinical case definition of sars has been developed for public health purposes ( ) . a person with a history of any combination of the following should be examined for sars: • fever (at least °c); and • one of more symptoms of lower respiratory tract illness (cough, difficulty in breathing, or dyspnea); and • radiographic evidence of lung infiltrates consistent with pneumonia or respiratory distress syndrome or postmortem findings of these with no identifiable cause; and • no alternative diagnosis can fully explain the illness. laboratory tests have been developed that include detection of viral rna by pcr from nasopharyngeal secretions or stool samples, detection of antibodies by enzyme-linked immunosorbent assay or immunofluorescent antibody in the blood, and viral culture from clinical specimens. available information suggests that close contact via aerosol or infected droplets from an infected individual provide the highest risk of acquiring the disease. most cases occurred in hospital workers caring for an index case or his or her close family members. despite the re-emergence of sars, it is highly unlikely that a case will be encountered in the custodial setting in the near future. however, forensic physicians must remain alert for the sars symptoms and keep up-to-date with recent outbreaks. information can be obtained from the who on a daily basis from its web site. if sars is suspected, medical staff should wear gloves and a surgical mask when examining a suspected case; however, masks are not usually available in custody. anyone suspected of sars must be sent immediately to the hospital, and staff who have had prolonged close contact should be alerted as to the potential symptoms. the most consistent feature of diseases transmitted through the fecaloral route is diarrhea (see table ). infective agents include bacteria, viruses, and protozoa. because the causes are numerous, it is beyond the remit of this chapter to cover them all. it is safest to treat all diarrhea as infectious, unless the detainee has a proven noninfectious cause (e.g., crohn's disease or ulcerative colitis). all staff should wear gloves when in contact with the detainee or when handling clothing and bedding, and contaminated articles should be laundered or incinerated. the cell should be professionally cleaned after use, paying particular attention to the toilet area. this viral hepatitis occurs worldwide, with variable prevalence. it is highest in countries where hygiene is poor and infection occurs year-round. in temperate climates, the peak incidence is in autumn and winter, but the trend is becoming less marked. all age groups are susceptible if they are nonimmune or have not been vaccinated. in developing countries, the disease occurs in early childhood, whereas the reverse is true in countries where the standard of living is higher. in the united kingdom, there has been a gradual decrease in the number of reported cases from to ( , ) . this results from, in part, improved standards of living and the introduction of an effective vaccine. the highest incidence occurs in the -to -year-old age group. approximately % of people older than years have natural immunity, leaving the remainder susceptible to infection ( ) . small clusters occur from time to time, associated with a breakdown in hygiene. there is also an increasing incidence of hav in gay or bisexual men and their partners ( ) . an unpublished study in london in showed a seroprevalence of % among gay men (young y et al., unpublished). the clinical picture ranges from asymptomatic infection through a spectrum to fulminant hepatitis. unlike hbv and hcv, hav does not persist or progress to chronic liver damage. infection in childhood is often mild or asymptomatic but in adults tends to be more severe. after an incubation period of - days (mean days) symptomatic infection starts with the abrupt onset of jaundice anything from days to weeks after the anicteric phase. it lasts for approximately the same length of time and is often accompanied by a sudden onset of fever. hav infection can lead to hospital admission in all age groups but is more likely with increasing age as is the duration of stay. the overall mortality is less than %, but % of people will have a prolonged or relapsing illness within - months (cdc fact sheet). fulminant hepatitis occurs in less than % of people but is more likely to occur in individuals older than years or in those with pre-existing liver disease. in patients who are hospitalized, case fatality ranges from % in - years olds to nearly % in those older than years ( ). the individual is most infectious in the weeks before the onset of jaundice, when he or she is asymptomatic. this can make control of infection difficult because the disease is not recognized. the main route is fecal-oral through the ingestion of contaminated water and food. it can also be transmitted by personal contact, including homosexuals practicing anal intercourse and fellatio. there is a slight risk from blood transfusions if the donor is in the acute phase of infection. it should not be considered a risk from needlestick injuries unless clinical suspicion of hav is high. risk groups include homeless individuals, homosexuals, idus, travellers abroad who have not been vaccinated, patients with chronic liver disease and chronic infection with hbv and hcv, employees and residents in daycare centers and hostels, sewage workers, laboratory technicians, and those handling nonhuman primates. several large outbreaks have occurred among idus, some with an epidemiological link to prisons ( , ) . transmission occurs during the viremic phase of the illness through sharing injecting equipment and via fecal-oral routes because of poor living conditions ( ) . there have also been reports of hav being transmitted through drugs that have been carried in the rectum. a study in vancouver showed that % of idus had past infection of hav, and they also showed an increased prevalence among homosexual/bisuexual men ( ). staff with disease should report to occupational health and stay off work until the end of the infective period. those in contact with disease (either through exposure at home or from an infected detainee) should receive prophylactic treatment as soon as possible (see subheading . . .). to minimize the risk of acquiring disease in custody, staff should wear gloves when dealing with the detainee and then wash their hands thoroughly. gloves should be disposed of only in the clinical waste bags. detainees with disease should be kept in custody for the minimum time possible. they should only be sent to the hospital if fulminant hepatitis is suspected. the cell should be quarantined after use and professionally cleaned. any bedding or clothing should be handled with gloves and laundered or incinerated according to local policy. detainees reporting contact with disease should be given prophylactic treatment as soon as possible (see subheading . . .). contacts of hav should receive hav vaccine (e.g., havrix monodose or avaxim) if they have not been previously immunized or had disease. human normal immunoglobulin (hnig), mg, deep intramuscular in gluteal muscle should be used in the following circumstances: • has the detainee traveled to africa, south east asia, the indian subcontinent, central/south america, or the far east in the last - months? • ascertain whether he or she received any vaccinations before travel and, if so, which ones. • ask if he or she took malaria prophylaxis, what type, and whether he or she completed the course. • ask if he or she swam in any stagnant lakes during the trip. • if the answer to any of the above is yes, ask if he or she has experienced any of the following symptoms: a fever/hot or cold flushes/shivering. diarrhea ± abdominal cramps ± blood or slime in the stool. a rash. persistent headaches ± light sensitivity. nausea or vomiting. aching muscles/joints. a persistent cough (dry or productive) lasting at least weeks. • take temperature. • check skin for signs of a rash and note nature and distribution. • check throat. • listen carefully to the lungs for signs of infection/consolidation. staff at higher risk of coming in to contact with hav should consider being vaccinated before exposure. two doses of vaccine given - months apart give at least years of protection. there is no specific treatment for hav, except supportive measures and symptomatic treatment. although the chance of encountering a tropical disease in custo dy is small, it is worth bearing in mind. it is not necessary for a forensic physician to be able to diagnose the specific disease but simply to recognize that the detainee/staff member is ill and whether he or she needs to be sent to the hospital (see tables - ) . this is best achieved by knowing the right questions to ask and carrying out the appropriate examination. tables - should be used as an aide to not missing some more unusual diseases. guidance for clinical 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of acyclovir for varicella pneumonia during pregnancy outcome after maternal varicella infection in the first weeks of pregnancy outcome in newborn babies given anti-varicella zoster immunoglobulin after perinatal maternal infection with varicella zoster virus varicella-zoster virus dna in human sensory ganglia epidemiology and natural history of herpes zoster and post herpetic neuralgia clinical applications for changepoint analysis of herpes zoster pain treatment of scabies with permethrin versus lindane and benzoyl benzoate treatment of ectoparasitic infections; review of the english-language literature nasal carriage of staphylococcus aureus: epidemiology and control measures centers for disease control and prevention. community-acquired methicillinresistant staphylococcus aureus infections-michigan methicillinresistant staphylococcus aureus, epidmiologic observations during a community acquired outbreak emergence of pvl-producing strains of staphylococcus aureus bacteriology of skin and soft tissue infections: comparison of infections in intravenous drug users and individuals with no history of intravenous drug use outbreak among drug users caused by a clonal strain of group a streptococcus. dispatchesemerging infectious diseases bacteriological skin and subcutaneous infections in injecting drug users-relevance for custody wound botulism associated with black tar heroin among injecting drug users isolation and identification of clostridium spp from infections associated with injection of drugs: experiences of a microbiological investigation team greater glasgow health board, scifh. unexplained illness among drug injectors in glasgow embolization of illicit needle fragments right ventricular needle embolus in an injecting drug user: the need for early removal departments of emergency medicine and pediatrics, lutheran general hospital of oak brook, advocate health system. emedicine-human bites prevention and treatment of dog bites human bites. department of plastic surgery guidelines for public health management of meningococcal diseases in the uk planning, registration and implementation of an immunisation campaign against meningococcal serogroup c disease in the uk: a success story efficacy of meningococcal serogroup c conjugate vaccine in teenagers and toddlers in england quadrivalent meningoimmunisation required for pilgrims to saudi arabia risk of laboratory-acquired meningococcal disease cluster of meningococcal disease in rugby match spectators immunisation against infectious disease. her majesty's stationery office ciprofloxacin as a chemoprophylactic agent for meningococcal diseaselow risk of anaphylactoid reactions joint formulary committee - . british national formulary notification of tuberculosis an updated code of practice for england and wales statutory notifications to the communicable disease surveillance centre. preliminary annual report on tuberculosis cases reported in england, wales, and the prevention and control of tuberculosis in the united kingdom: uk guidance on the prevention and control of transmission of . hiv-related tuberculosis . drug-resistant, including multiple drug-resistant, tuberculosis. department of health, scottish office control and prevention of tuberculosis in the united kingdom: code of practice epidemiology of tuberculosis in the united states nosocomial transmission of multi-drug resistant tuberculosis among hiv-infected persons-florida the continued threat of tuberculosis tuberculosis-a clinical handbook the white plague: down and out, or up and coming? a prospective study of the risk of tuberculosis among intravenous drug users with human immunodeficiency virus infection influence of tuberculosis on human immunodeficiency virus (hiv- ): enhanced cytokine expression and elevated b -microglobulin in hiv- associated tuberculosis the chest roenterogram in pulmonary tuberculosis patients seropositive for human immunodeficiency virus type coronavirus as a possible cause of severe acute respiratory syndrome epidemiological determinants of spread of causal agents of severe acute respiratory syndrome in hong kong alert, verification and public health management of sars in post-outbreak period age-specific antibody prevalence to hepatitis a in england: implications for disease control phls advisory committee on vaccination and immunisation. guidelines for the control of hepatitis a infection control of a community hepatitis a outbreak using hepatitis a vaccine seroprevalence of and risk factors for hepatitis a infection among young homosexual and bisexual men outbreaks of hepatitis a among illicit drug users identifying target groups for a potential vaccination program during a hepatitis a community outbreak multiple modes of hepatitis a transmission among metamphetamine users past infection with hepatitis a among vancouver street youth, injection drug users and men who have sex with men implications for vaccination programmes key: cord- - agnsbyd authors: turner, bryan stanley; dumas, alex title: vulnerability, diversity and scarcity: on universal rights date: - - journal: med health care philos doi: . /s - - - sha: doc_id: cord_uid: agnsbyd this article makes a contribution to the on-going debates about universalism and cultural relativism from the perspective of sociology. we argue that bioethics has a universal range because it relates to three shared human characteristics,—human vulnerability, institutional precariousness and scarcity of resources. these three components of our argument provide support for a related notion of ‘weak foundationalism’ that emphasizes the universality and interrelatedness of human experience, rather than their cultural differences. after presenting a theoretical position on vulnerability and human rights, we draw on recent criticism of this approach in order to paint a more nuanced picture. we conclude that the dichotomy between universalism and cultural relativism has some conceptual merit, but it also has obvious limitations when we consider the political economy of health and its impact on social inequality. the generic concepts of 'ethics of rights' and 'ethics of duties' (patrão neves )-found implicitly in most official bioethics documents-can be viewed as two relevant ideas for a sociological study of human rights and global health policy. they identify basic human needs and socio-cultural conditions that should be safeguarded by political institutions. the fact that health is now considered a basic good within international conventions is an important point of departure for universal rights to health (unesco ) . the duties that are associated with these rights are also expressed by the moral obligation to develop a social contract that would achieve a modicum of social justice by for example reducing social inequalities. both dimensions of the ethics debate (rights and duties) converge on the notion of 'institution'. in sociology, the problems of developing universal institutions to achieve a civilized level of social protection, while respecting personal autonomy, lie at its core. in an effort to promote 'multidisciplinary and pluralistic dialogue' (unesco ) in bioethics, this article makes a contribution to ongoing debates about universalism and cultural relativism from the perspective of sociology. we argue that bioethics has a universal range because it relates to three shared human characteristics,-human vulnerability, institutional precariousness and scarcity of resources. these three components of our argument provide support for a related notion of 'weak foundationalism' that emphasizes the universality and interrelatedness of human experience, rather than their cultural differences. after presenting a theoretical position on vulnerability and human rights, we draw on recent criticism of this approach in order to paint a more nuanced picture. we conclude that the dichotomy between universalism and cultural relativism has some conceptual merit, but it also has obvious limitations when we consider the political economy of health and its impact on social inequality. the idea that different cultures produce not only different ethics and values but also vastly different ways of experiencing the world has become the dominant assumption of both anthropology and sociology. in terms of philosophical anthropology, our social being-in-the-world is deeply rooted in distinctive and separate sets of cultural practices, often referred to simply as 'habitus' (bourdieu ) . the implication is that we cannot assume that the experiences of sickness and disease, and experiences of the body are universal and it follows that some assumptions of western bioethics cannot be generalized. in sociology the problem of relativism occurs under the general discussion of 'social constructionism', namely that the phenomena of the social world have no consistent or permanent essence; they are always and already produced by social conditions. perhaps the classic illustration of the argument was the work of margaret lock ( ) on the cross-cultural experience of menopause in american and japanese women. she found that, while the discomforts of menopause in the united states were widely prevalent, japanese women did not experience negative symptoms to the same extent. medical sociologists therefore concluded that the social construction of menopause was at the source of its medicalization in some areas of the word. while social constructionism is a basic premise of modern anthropology and sociology, it has certain limitations in the context of rights. we defend the idea some conditions such as human vulnerability, precariousness institutions and scarcity of resources, are common to human societies and can serve as a grounding for future research in bioethics. in short we defend a position that we call 'weak foundationalism'. without rejecting cultural relativism, we argue that humans share a physical embodiment, which has significant consequences regardless of cultural variations. for example, the prospect of post-humanism is threatening to alter what it is to be human and is generating many ethical questions that appear to go beyond cultures or religious denomination; it is in this perspective that the study of embodiment in social sciences is central to ethical life (frank : ) . we also elaborate the notion of institutional precariousness that occurs in context of scarcity. the result is that over many issues we have to co-operate through mutual recognition just in order to survive. we start with the observation that cultural relativism runs up against at least two obvious counter arguments. the first is that the notion of cultural specificity is contradicted by the widespread assumption in the social sciences that globalization is the dominant form of social change in the modern world. globalism is especially evident in the fact that the world is shaped by a common technology and production system. for example, access to medical technology, international vaccination co-ordination efforts, and sharing of information through the world health organisation can be viewed as proof that most countries are to some degree part of globalized networks. while the interaction between global and local cultures often results in hybrid cultures that sociologists describe as a process of 'glocalization', there are important common processes that result in shared problems and experiences. medical anthropologists, by grasping the relativist implications of her work, can too easily ignore one of the conclusions of margaret lock's research, which was that japanese women would come to acquire menopausal difficulties as a result of globalization. this first point is supported primarily by the nature of human ageing, demographic data and considerations on the specificity of the social classification of disease. let us take two examples of the emergence of a common 'health world' with respect to globalization and health. perhaps the most important demographic revolution of the late twentieth century was the decline in female total fertility rates and the greying of human populations. this demographic change is more or less uniform regardless of cultural differences and especially religious differences. by the beginning of this century, only four countries in the world have a fertility rate above five, and half the world's population now live in societies that have fertility rates that are near or below the replacement level (macinnes and pérez diaz : ) . obviously there are important differences. china's one-child policy is very different from the demographic situation of the united states, but there are common global processes: the improvement in female education, the availability of contraceptives, rising prosperity of the middle classes and changing attitudes towards children. in association with changing fertility, there is the longer life expectancy and lower death rates that translate into a strong trend of ageing of the world's population. for most societies demography is central to various health, labour and economic policies. it would also be possible to construct a list of such shared health circumstances related to ageing-cancer, alzheimer's disease, strokes, and so forth. with globalization, there is the rapid transmission of conditions such as hiv/aids, sars, and the annual influenza outbreak. there are also more 'exotic' problems such as the arrival and spread of west nile virus to texas where people died and , were infected in the summer of . we can therefore legitimately argue that in the past humans lived in communities that were more or less isolated and hence diseases with geographically and culturally specific. this communal autonomy and isolation was relative. in the medieval world, the bubonic plague devastated human communities across much of europe. the modern world is very different. an outbreak of sars in east asia can reach ottawa in a matter of days if not hours. another example would be diabetes. there is a worldwide epidemic of diabetes. it is clearly widespread among urban, sedentarized and developed societies from australia to the united states, where lack of exercise, fast food and urbanization contribute to its rising incidence among young people. obviously more efficient detection and monitoring contribute to the growth of the disease, but it is also widespread among indigenous peoples from australian aboriginals to native americans. the second counter argument is the widespread, if not universal, acceptance of human rights. sociologists have suggested that the cultural contexts of moral debate are not as radically incommensurable as many philosophers suggest, and thus the process of globalization has provided a counter-balance to national and cultural diversity (mouzelis ). the contemporary almost universal acceptance of human rights suggests that the globalization of the principles of the declaration of can mitigate if not overcome the fragmentation and diversity of human cultures. there are of course many well-known problems with human rights, such as the difference between the acceptance and enforcement of rights (woodiwiss ). human rights began to emerge on the global political agenda in the s when growing dissatisfaction with the historic the role of states in the international order and widespread recognition of the failures of communism opened up opportunities for rethinking the role of rights in international affairs. human rights emerged as a serviceable ideology for a variety of social movements such as women's internationalism, political dissidents in poland and hungary, and as the basis of global ngo activity. the presidency of jimmy carter, who in his inauguration in declared an absolute commitment to human rights as the basis of american foreign policy, was also an important development. however, the critical turning-point occurred when academic lawyers came to embrace human rights as the normative framework of international law. these lawyers, who began to question the prevailing realist doctrines of international relations theory, embraced human rights as part of their core business (moyn ) . one standard argument against human rights has been that they are western and individualistic. but even this argument has lost a lot of traction. the so-called 'asian values debate' has more or less disappeared. at one stage both mahatir in malaysia and lee kwan yew in singapore sought to ground a view of human rights in confucianism with its emphasis on the family, order and respect, but for critics of these societies such values were thought to be a screen to hide the authoritarianism of their respective regimes (kamaludeen and turner ) . although the spread of human rights is far from complete, there is a growing network of international law that is binding on nations. the united nations convention on the law of the sea ( ) is a significant illustration of this development (charney and smith ) . the growth of legally binding relations within the european community has also been seen by legal scholars as an important example of legal internationalism. for example in the treaty establishing the european coal and steel community made provision for an independent court, the court of justice, to interpret and enforce of the treaty's provisions. another example is the creation of the european court of human rights in . these international legal relations have multiplied with juridical globalization in clear recognition of the need to develop a set of universal norms to address global concerns relating to major issues, especially the environment (charney ) . in addition, important normative instruments developed in bioethics and human rights over the last decades (e.g., declaration of helsinki, belmont report, european convention on bioethics, universal declaration of bioethics and human rights) have identified a number of shared human conditions that should be preserved through political means. the notion of shared vulnerability-that is commonly used in bioethics as an answer to relativistic claims in health policy-is a good example in this regard. generally speaking, the notion of vulnerability holds two meanings. first, the word refers to a universal and persistent character of human beings (e.g., kottow ; luna ; patrão neves ; ruof ) . in some respect, it holds an ontological priority over other bioethical principles (solbakk ) . second, it holds a more variable status, which is dependent on a sociocultural context. socioeconomic inequalities increase vulnerability, and humans thus become vulnerated and, as a consequence, more susceptible to disease and shorter lives (kottow ) . essentially, global rights institutions and conventions protect humans because they are vulnerable. the arguments invoking a 'bioethics of protection' or a 'duty to aid' often put forward the significance of international solidarity as an answer to health inequalities (e.g., schramm and braz ; london ) . as stated in a recent report of the international bioethics committee: ''vulnerability might provide a bridge between the moral 'strangers' of a pluralistic society, thereby enhancing the value of solidarity rather than mere individual interest'' (unesco : ). economic development does not automatically reduce the vulnerability of every sector of society, and hence there is a continuing need for basic forms of protection. vulnerability, diversity and scarcity with respect to recent biotechnological developments, various treaties and conventions on the integrity of the human species testify to the existence of a global risk society. in 'protecting the endangered human ' annas, andrews and isasi ( ) suggest an international treaty prohibiting cloning and inheritable alterations in response to species altering technology: 'prevention … must be based on the recognition that all human are the same, rather than on an emphasis on our difference ' ( : ) . we believe that sociological arguments about globalization and human rights can contribute to philosophical debates in bioethics since the empirical findings of sociological research have an obvious bearing on bioethics and health policy. however we do not want to present a counter argument in terms of various empirical examples. we need to develop our position at a much more fundamental and conceptual level. these examples from our discussion so far indicate that what human beings share in common, even when they are profoundly divided by culture and religion, is their ontological vulnerability. this point has been emphasized in vulnerability and human rights, in which turner ( ) argued from a sociological perspective that the concept of vulnerability, which is derived from the latin vulnus or 'wound', recognises the corporeal dimension of human existence, namely our embodiment; it describes the condition of sentient, embodied creatures, who are exposed to the dangers of their natural environment, and who are conscious of their precarious circumstances. our vulnerability signifies our capacity to be open to wounding, and therefore to be open to the world. this theme of human vulnerability clearly has strong religious connotations. it can be easily related to the christian tradition the symbol of which is the cross of jesus. but it can also be recognized in the teachings of the buddha. in a discussion of the buddhist idea of dukkha or suffering, robert bellah ( : ) notes that it can also be translated as meaning that life is 'unsatisfactory'. one reason life is less than satisfactory is because we experience it as transient and tragic. he concludes that 'fundamentally it is the recognition of the vulnerability and fragility of life' (bellah : ) . one might also relate this concept of human vulnerability to the shi'ite tradition of islam with its profound sense of martyrdom and suffering. these comparisons suggest that vulnerability is not cultural specific but speaks to the human condition as a shared ontology. human beings are ontologically vulnerable and insecure, and their natural environment, uncertain. in order to protect themselves from the uncertainties and challenges of the everyday world, they must build social institutions (especially political, familial and cultural institutions) that come to constitute 'society'. we need a certain level of trust in order to build companionship and friendship to provide us with mutual support in times of uncertainty. we need the creative force of ritual and the emotional ties of common festivals to renew social life and to build effective institutions, and we need the comforts of social institutions as means of fortifying our individual precarious existence. because we are vulnerable, it is necessary to build political institutions to provide for our collective security. these institutions are, however, themselves precarious and they cannot begin to function without effective leadership, political wisdom and good fortune to provide an enduring and reliable social environment. however rituals typically go wrong; social norms offer no firm or enduring blue-print for action in the face of rapid social change; and the guardians of social values-priests, academics, lawyers and politicians-turn out to be all too easily open to corruption, mendacity and self interest. nevertheless the uncertainties and contingencies of everyday life also generate inter-societal patterns of dependency and connectedness, and in psychological terms this shared world of risk and uncertainty results in sympathy, empathy and trust without which society would not be possible. all social life is characterised by this contradictory, unstable and delicate balance between scarcity, solidarity and security. in its report on the principle of respect for human vulnerability and personal integrity, the international bioethics committee notably indicates that the 'most significant worldwide barrier to improving the levels of attainment of health through health care interventions is the scarcity of resources' (unesco : ) . drawing on sociology, in recent publications we have placed greater emphasis on this problem of scarcity (especially on the political economy of scarcity), because we believe that debates about human rights have often neglected some of the basic economic problems associated with rights claims. the idea of scarcity has been a basic assumption of economics in which, considering its most generic meaning, it signifies a shortage of means to achieve desirable ends of action. a shortage of income means that i cannot purchase basic commodities to satisfy needs such as food and shelter. adam smith in the wealth of nations recognized the often negative consequences of swings between years of plenty and years of scarcity, and in the latter case for example in , workers could often be hired for less than subsistence. our arguments relating to vulnerability and precariousness also have an economic dimension by grasping the relationship between vulnerability and economic analysis of environment. in the entropy law and the economic process, nicholas georgescu-roegen ( ) argued that waste is an unavoidable aspect of the development process of modernization, and that human beings inevitably deplete natural resources and create environmental pollution. economic progress merely speeds up the inevitable exhaustion of the earth's natural resources. georgescu-roegen's theory showed that classical economics had neglected the problem of natural scarcity, thinking that technology and entrepreneurship could eventually solve the problem described by thomas malthus of population growth in relation to fixed resources. his economic theory of waste applied the ideas of alfred lotka ( ) on biology to the accumulation of capital. human beings have to rely on what lotka called 'exosomatic instruments' to develop the environment, unlike animals which depend on 'endosomatic instruments'. in some respects this distinction is an old anthropological argument. reptiles evolve wings to fly; human beings create aeroplanes. however, wings involve low entropy solutions and do not deplete natural resources; technological solutions, such as jet-propelled aeroplanes, are high entropic solutions that use up finite energy. because humans are ontologically vulnerable, they develop high entropy strategies that have the unfortunate consequence of creating a precarious environment. more importantly, the entropy law implies a pessimistic conclusion that social conflict is inevitable. because resources are scarce, humans degrade their environment, and they must consequently compete within limited space. these malthusian conditions of social conflict in modern times have been further exacerbated by the mechanization of violence and by the de-stabilising impact of new wars. we can as a result interpret social citizenship as an institutional attempt to reduce conflict through, typically modest, income redistribution in the framework of the nation state, and human rights as conflict-reducing instruments between and within states. as argued by etzioni ( ) , increased social divisions and power of lobby groups can be linked to moral relativism. although this assertion has been criticized, it shows that systems that privileges the virtues of the market and individual freedom, fail to nurture the roots of the community (turner and rojek ) . while recognizing the common vulnerability of human beings, as sociologists we cannot ignore the precariousness of human institutions and the basic condition of scarcity. in order to engage with other human beings as moral agents worthy of our respect, there has to be mutual recognition. this basic starting point of ethics is referred to as 'recognition ethics' (williams ) . in a human community, this basic act of recognition requires some degree of equality. for example, hegel's master-slave analysis takes account of the fact that neither slave nor master can arrive at mutual recognition, because the master perceives the slave as his property, while the slave is too lowly to recognise the master. hence, without some degree of social equality, there can be no ethical community, and hence a system of rights and obligations cannot function. material scarcity undercuts the roots of social community without which conscious, rational agency is always compromised. taking their cue from the critique of liberal theories of rights by karl marx ( - ) , sociologists have remained sceptical about human rights traditions that have no corresponding social policies to secure some minimum level of equality through strategies of redistribution such as progressive taxation (waldron ) . rights to individual freedoms without democratic egalitarianism are thought to be merely symbolic not real claims for recognition. without some degree of equality, however basic, bioethics can have no real purchase on the social world. recognition requires some basic redistribution. the vulnerability thesis has received some criticism because it is very relevant to some human rights but not to others. it is limited by its inability to explain the individual rights of liberalism. in fact, it is often is used to prevent excess freedom that may increase inequalities. it can also be criticised on the grounds that we do not automatically feel responsible for the suffering of others. relativism 'opens the door' to moral queuing principles in function of interest groups and political agendas. in luc boltanski's distant suffering ( ) , there has been some discussion about whether we can sympathize with those with whom we are not connected. our argument that embodiment is a valid basis for the defence the universalism of human rights is partly grounded in the notion of the ubiquity of human misery and suffering. in arthur schopenhauer opened his essay 'on the suffering of the world' ( ) with the observation that every 'individual misfortune, to be sure, seems an exceptional occurrence; but misfortune in general is the rule'. while the study of misery and misfortune has been the stuff of philosophy and theology, there is little systematic study of these phenomena by sociologists. one exception is barrington moore ( : ) who argues in reflections on the causes of human misery that 'suffering is not a value in its own right. in this sense any form of suffering becomes a cost, and unnecessary suffering an odious cost'. in general political opposition to human misery becomes a stand-point that can transcend and unite different cultures and values. a critic might object that suffering is too variable in its cultural manifestations and too indefinite in its meanings and local significance to provide such a common, indeed universal, standpoint. what actually constitutes human vulnerability, diversity and scarcity suffering might well turn out to be culturally and historically specific. those who take note of the cultural variability of suffering have made similar arguments against a common standard of disability. although one could well accept this anthropological argument on the grounds that suffering involves essentially the devaluation of a person as a consequence of accident, affliction or torture, pain is less variable. whereas bankruptcy for example could involve some degree of variable psychological suffering through a loss of face, a toothache is a toothache. if we claim that disability is a social condition (basically the loss of social rights) and thus relative, we might argue that impairment is the underlying condition about which there is less political dispute or philosophical uncertainty. in short, some conditions or states of affairs are less socially constructed than others. suffering is often, perhaps always, a threat to our dignity, which is obviously culturally variable. pain by signalling a deeper somatic malfunction is a threat to our existence. yet another criticism is the medical technology paradox. the more medical science improves our global health condition, the less vulnerable we are. therefore technological progress could make this vulnerability thesis historically specific. in principle if we live longer, because we have become less vulnerable with advances in medical technology, then the relevance of human rights might well diminish. this paradox however helps us to sharpen our argument, which is that we are human, because we are vulnerable. the irony of medical advances is that we could only finally escape our vulnerability by ultimately escaping from our own humanity. technological change threatens to create a post-human world in which, with medical progress, we could in principle live forever. this criticism presents an interesting argument, but there are two potentially important counter-arguments. the first is that, if we could significantly increase our life expectancy, then we would live longer but in all probability with higher rates of discomfort and disability. the quantity of life might increase in terms of years, but there would be a corresponding decline in its quality. a post-human world is a medical utopia that has all the negative features of a brave new world. secondly, medical improvements in the advanced societies are likely to increase the inequality between societies, creating a more unequal and insecure international order. in such a risk society, where human precariousness increases and human vulnerability decreases, the need for human rights protection would continue to be important. the prospect of living forever might require us to inhabit, in max weber's pessimistic metaphor, an 'iron cage' in which our existence is by courtesy of lifesupport machines. a post-human world would in principle require a different ethical system namely a post-human ethics (fukuyama ) . scarcity is nonetheless at the centre of bioethics. for many scholars, scarcity is regarded as socially constructed in the sense that it is produced by a consumer culture in which expectations are elastic and diverse. the theory of positional goods suggests that demand for status goods can be controlled only with great difficulty (hirsch ) . our notion of inescapable vulnerability may be questioned by the optimism often generated by medical technologies that promise to provide replacement organs, brain implants, and a wealth of interventions aims to extend life 'indefinitely'. the task of bioethics is to address the problems of scarcity in societies of abundance and to consider the consequences of medical technology that will increase social inequality. with the scarcity of resources, there is always social competition and conflict-even in the richest societies of the developed world (turner and rojek ) . the occupy wall street slogan-we are the %-may become a relatively permanent feature of social movements in this century. there are few discussions on the nature of scarcity in terms of bioethics. if scarcity itself is not a product of modernity, globalization, or ageing populations, new technologies are important factors involved in the politics of life. bioethics will need to consider its relations to humans suffering and protective institutions. geriatric technologies are bringing new standards of longevity and quality of life, and are generating new social and ethical questions. characteristics of patients such as age, capacity to pay, degree of success of medical intervention, and social value of the individual, are all deciding factors that are used to different degrees that determine access to health care in the face of scarcity (moody ) . the opportunity costs of massive investments of health care for older populations are also being evaluated in terms medical ethics and social justice. ageing societies are faced with the difficult questions of 'choosing who's to live', and under what conditions, by limiting resources for the very old (walters ) . researchers in biogerontology have revived the medical utopia of wanting to significantly extending life well beyond the current human life span, situated approximately at years. whether this life extension is achievable or not is somewhat irrelevant for our discussion. however, the justifications for funding such a project have been interpreted as 'cutting through ethics' turner , ) . our criticism of cultural relativism does not endorse a pure foundationalist approach; we recognize that societies are different and have different value systems. however, we cannot minimise the import of universalist claims because there are shared similarities between humans and potent social forces such as globalization that shape and reshape human experiences. perhaps bioethics is deemed to follow a version of the 'glocalization' model, where, on the one hand, it would acknowledge and act upon the fact that globalized forces are being opposed to the legitimate resistance of local cultures, and on the other hand, it would strongly promote universal thresholds when in comes to health and human rights. our contribution to the understanding of conventional bioethics is also based in the strong assumption that there is always a struggle over scarce resources and that scarcity will continue to dominate the lives of large sections of the population, even within the wealthiest countries (bury ) . bioethics needs political economy. if we do not hold any firm foundationalist arguments in contexts of scarcity, we must recognize the inflation of demand for health technologies, increased competition for scarce resources and increased health inequalities. we note that our argument is somewhat similar to the position taken by hervé juvin ( ) in the coming of the body. for juvin, globalized societies are market-driven and characterized by individualism, indeterminacy, increased concerns over health and body appearance. without a strong and forceful legal framework that overrides individual investments in biomedicine, social inequalities will increase further eroding social and intergenerational relations. opposition to austerity measures in many european societies in may become a regular feature of street politics with growing unemployment and increasing inequality. indignation against visible inequality may evolve into political rage (reich ). furthermore, a strict opposition between universalism and cultural relativism is problematic because related forms of ethics are characterized by mutual recognition and empathy between people of different cultures. these forms of ethics also recognize cultural identity as a key component of agency, and without sufficient agency it is difficult to mobilize individuals to preserve their institutions. political anthropology has been dealing with these tensions for some time; however they are mainly framed in efforts to safeguard cultural diversity, which is quite different from the problem of sustaining human rights and bioethics. sociology has brought more attention towards increasing social inequalities. amongst other things, income inequality underlines new power struggles over life and health between the rich and the poor areas of the world. assuming there is a connection between health and wealth, relativism can nourish liberalism in biomedicine to the expense of vulnerable groups. post-humanists, for example, are transforming the discursive space in which bioethical debates are taking pace, and are proposing a detraditionalization of biomedical practices,-a process described as a moving away from nature and tradition that is essentially market-driven (giddens ) . this opposition to 'tradition' is radically changing the foundations of a politics of life. contemporary health care systems and research policies are faced with ethical questions that are derived from the relationship between the 'infinite demand' for health care services and the 'finite systems' of institutions (foucault ) . scarcity is thus creating an 'ethic of limits' in which universal claims for global health are being challenged by various forms of relativism. in this regard, a sharper focus on social inequalities in bioethics within the on-going discussion on cultural diversity will certainly clarify universal thresholds regarding health status and reinforce key objectives of social justice that are central to all major conventions in human right and bioethics. protecting the endangered human: toward an international treaty prohibiting cloning and inheritable alterations religion in human evolution distant suffering: morality, media and politics pascalian meditations. cambridge: polity press. bury, m. . health, ageing and the lifecourse universal international law international maritime boundaries the life extension project: a sociological critique statecraft and soulcraft: foucault on prolonging life the spirit of community social security the varieties of my body: pain, ethics and illusion the entropy law and the economic process affluence, poverty, and the idea of a post-scarcity society. geneva: united nations research institute for social development the social limits to growth the coming of the body governing as gardening: reflections on soft authoritarianism in singapore. citizenship studies vulnerability: what kind of principle is it? medicine encounters with aging. mythologies of menopause in japan and north america justice and the human development approach to international element of physical biology elucidating the concept of vulnerability. layers not labels transformations of the world's population: the demographic revolution aging and controversies reflections on the causes of human misery and upon certain proposals to eliminate them encyclopedia, genealogy and tradition: a sociocultural critique of macintyre's three moral discourses the last utopia. human rights in history beyond outrage. what has gone wrong with our economy and our democracy, and to fix it vulnerability, vulnerable populations, and policy on the suffering of the world bioethics of protection: a proposal for the moral problems of developing countries the principle of respect for human vulnerability and global bioethics vulnerability and human rights universal declaration of bioethics and human rights report of the international bioethics committee of unesco on social responsibility and health report of the international bioethics committee of unesco on the principle of respect for human vulnerability and personal integrity nonsense on stilts. bentham, burke and marx on the rights of man introduction. in choosing who's to live: ethics and aging hegel's ethics of recognition taking the sociology of rights seriously key: cord- - wfyaxcb authors: ubokudom, sunday e. title: physical, social and cultural, and global influences date: - - journal: united states health care policymaking doi: . / - - - - _ sha: doc_id: cord_uid: wfyaxcb in chap. , we examined the technological environment of the health care policy-making system. specifically, we examined the classification, evolution, and diffusion of medical technology; the effects of medical technology on medical training and the practice of medicine; effects on medical costs, quality of care, and quality of life; effects on access to care; the ethical concerns raised by medical technology; and the practice of technology assessment. we concluded the chapter by observing that the growth of technology, as well as other human endeavors, affects other important aspects of our lives, most notably, the air we breathe, the food we eat, the generation of radioactive by-products and toxic chemicals, the manufacture of illicit drugs, and the generation of natural and man-made hazards. in other words, in addition to their effects on the health care system, technology and other human activities affect many other aspects of our lives that are associated with health. the who's defi nition of health as "a complete state of physical, mental, and social well-being, and not merely the absence of disease or infi rmity" (who ) , is primarily based on the wellness model. in this defi nition, emphasis is put on the fact that health is not merely the absence of disease, but also involves a social dimension. therefore, it also emphasizes the social and fi nancial support systems identifi ed in table . of chap. . this defi nition of health, as involving the combination of physical, mental, and social well-being led to the concept of the "health triangle." the health triangle left out the spiritual dimension of health, which has recently gained signifi cant attention in the literature due to a growing interest in the notion of holistic health. holistic health stresses the importance of all the things that make a person whole and complete. in addition to the three dimensions of the health triangle, of his analysis (szreter , p. ) . subsequent studies revealed that the cessation of the large-scale redistribution of income and wealth from the very rich to the poorest in society had adverse effects on the health of the population. for example, when unhealthy behaviors and lifestyles were held as constant as possible, studies showed that people of lower socioeconomic status were more likely to die prematurely than were people of higher socioeconomic status (isaacs and schroeder , p. ; smith et al. , p. ; davey smith et al. , p. ) . the relationship between physical, social and cultural, and global environmental factors and health status is very well documented. in a letter to the editor of the jama , winkelstein ( winkelstein ( , p. argues that curative medical care, or those practices that are used for the care and rehabilitation of the sick, which involve most of the physical and designed social technologies listed in table . of the previous chapter, is not the same as health care. medical care, as he defi nes it, makes only modest contributions to the health status of the population. on the contrary, the health status of the population is largely determined by a different set of factors that involve important physical, social, and economic components. these include preventive medicine, genetic predisposition, social and economic circumstances, environmental conditions, lifestyles and behaviors, and medical care (mckeown ; kannel et al. ; belloc and breslow , p. ; bunker et al. ; bunker et al. , p. ; marmot et al. marmot et al. , p. bell and standish , p. ; mcginnis et al. , p. ; wilkinson wilkinson , p. . we briefl y examine each of the identifi ed determinants of health below. preventive medicine seeks to minimize the occurrence of illness and disease. unlike the medical model that is reactive and seeks to contain disease and ill-health after they have occurred, preventive medicine is proactive and seeks to minimize the likelihood of the occurrence of disease and ill-health. generally, there are three areas or types of preventive measures, namely: primary prevention, secondary prevention, and tertiary prevention. primary prevention seeks to stop or minimize the development of disease or ill-health before it occurs. primary prevention may involve counseling against smoking, in order to prevent the development of chronic emphysema or chronic obstructive pulmonary disease (copd) and lung cancer. other primary interventions may include the promotion of an active lifestyle or exercise program, in order to minimize the likelihood of excess body fat and heart disease; driver education and mandatory seatbelt and motorcycle helmet laws, in order to reduce motor vehicle accidents and accidental head injuries; vaccinations for various forms of diseases and illnesses, such as measles and rubella, which can minimize the occurrence of early childhood diseases and mortality; and water purifi cation and sewage treatment programs that can minimize the occurrence of typhoid, cholera, and other waterborne diseases. secondary prevention involves the early detection and treatment of disease. health screenings and periodic and regular health examinations, such as hypertension screenings, mammograms, and pap smears, serve as examples of secondary prevention measures. these examples fall under the broad category of health promotion discussed in chap. . the benefi ciaries of these programs are currently healthy people who are targeted to improve their health-related behaviors in order to minimize their chances of developing catastrophic and expensive illnesses. as was discussed in chap. , secondary prevention measures are some of the most cost-effective steps employers take to lower their health benefi t costs ( coffi eld et al. , p. ) . tertiary prevention measures involve steps taken to reduce the complications of diseases or illnesses, or to prevent further illnesses. they involve rehabilitative practices and the monitoring of the process of health care delivery. the infection control practices in hospitals and other improvements in the methods of health care delivery discussed in chap. , under the postindustrial period of the evolution of the health care system, which are intended to reduce the occurrences of nosocomial infections and iatrogenic illnesses, are practical examples of tertiary prevention measures. other examples include patient education, nutrition counseling, and behavior modifi cation programs that seek to prevent the recurrence of disease and illness (timmreck , p. ) . since the mid- s in the united states, there have been signifi cant reductions in heart disease, stroke, personal injury, and non-tobacco-related death rates foege , p. ; banta and jonas , p. ) . similarly, the data presented in table . of chap. show signifi cant declines in death rates related to heart disease, cancer, stroke, infl uenza and pneumonia, chronic liver disease or cirrhosis, human immunodefi ciency virus (hiv) disease, suicide and homicides, from to . these particular declines appear to be the result of preventive health measures, such as early screening, detection and treatment of hypertension, the provision and utilization of pneumonia and infl uenza vaccinations, moderate alcohol intake or abstinence, safe sex practices, suicide prevention and anger management programs, increased use of seatbelts and reductions in driving-underthe-infl uence episodes, smoking cessation, and the lowering of dietary fat and cholesterol. if, at least, some of the declines in mortality discussed above are due to preventive measures, the preventive strategy has yielded signifi cant gains in health. perhaps, it is this recognition of the importance of preventive services that led to the establishment of the us preventive services task force (uspstf) in . most likely, it was the recognition of the crucial role that preventive medicine plays in enhancing population health that led to the convening of the uspstf in by the us public health service. the task force is a leading independent panel of nationally recognized nonfederal experts in prevention and evidencebased medicine. programmatic responsibility for the task force was transferred to the agency for health care research and quality (ahrq) in (uspstf procedure manual ). the uspstf is assigned the responsibility of making evidence-based recommendations that address primary and secondary preventive services targeting conditions that represent a substantial burden in the country, and that are provided in primary care delivery settings or made available through primary care referrals. the task force's recommendations are intended to improve clinical practice and promote the public health. tertiary prevention measures are outside the scope of the uspstf. even though the main audience for task force recommendations is the primary care provider, the recommendations are also used to guide programmatic, funding, and reimbursement decisions by policy-makers, managed care organizations, public and private payers, quality improvement organizations, research institutions, and consumers. beginning at the end of may , the uspstf changed the grades it assigns to its recommendations. it assigns one of fi ve possible letter grades, a, b, c, d, or i, to each of its recommendations, including "suggestions for practice" associated with each grade. the agency also defi nes the levels of certainty regarding the net benefi t of each of its recommendations. the task force's reduction of the grade given for evidence quality from "b" to "c" for routine mammograms in women under the age of years generated signifi cant controversy among health professionals and politicians (kinsman ) . in addition to the mammography recommendations stated above, the uspstf has recently recommended against screening for testicular cancer in adolescent or adult males (grade d recommendation) (uspstf , p. ) . it has also concluded that there was insuffi cient evidence to assess the balance of benefi ts and harms of screening for bladder cancer in asymptomatic adults (moyer , p. ) , and that prostate-specifi c antigen (psa) screening was associated with psychological harms, while its potential benefi ts remained uncertain (lin et al. , p. ) . table . shows the approach adopted by the agency in june , to rank its recommendations. health is dependent upon biological factors. our predispositions to health or disease begin to take shape at the moment of conception. these predispositions are embedded in our genetic code. the genetic code guides the development of the proteins that determine our phenotypes (sizes, shapes, personalities, hair color, etc.) and genotypes or those aspects of our genetic codes that we cannot see, such as the biologic limit of our life expectancies (mcginnis et al. , p. ; khoury et al. ; bell and standish , p. ; starfi eld , p. ; blum ; centers for disease control and prevention (cdc) ) . genetic factors predispose individuals to certain diseases. but although an individual may have a strong likelihood of developing a particular disease, this propensity to develop the disease is signifi cantly enhanced by environmental factors. for example, some studies demonstrate that there is a genetic basis for alcoholism (reich ) . but a person who has never taken a drink will not become an alcoholic. some triggers, in this case, the availability and consumption of alcohol, are necessary for the individual to progress from being genetically predisposed to alcoholism to actually (berkman and breslow ; burnett ; banta and jonas , p. ; davis and webster , p. ) . these examples suggest that the interaction between genetic factors and the environment in producing a particular disease is complex. while people have little or no control over their genetic makeups, the lifestyles and behaviors they freely choose and the surroundings where they live can have signifi cant infl uences on the likelihood of developing a particular disease to which they are genetically predisposed. to further the discussion of the infl uence of genetics on health, mcginnis et al. ( , p. ) cite studies which show that although only about % of deaths in the united states may be attributed to purely genetic diseases, about % of late-onset disorders, such as diabetes, cardiovascular disease, and cancer, have some genetic component. for example, the brca gene accounts for only between and % of breast cancers in the united states; only about % of colon cancers may be explained by genes, and only about % of elevated serum cholesterol levels may be explained by familial hyperlipidemia. similarly, studies of identical twins focusing on the occurrence of schizophrenia, and other twin studies examining the occurrence of dementia in older people, have found that about half of each might be explained by genetic factors. further, while about two-thirds of the risk of obesity might be genetic, the risk is expressed only with exposure to controllable lifestyle factors (baird , p. ; muller , p. ; panjukanta et al. , p. ; kendler kendler , p. rowe and kahn ) . the institute of medicine (iom) ( , p. ) reported that americans in , compared with those who lived in , were healthier, lived longer, and enjoyed lives that were less likely to be marked by injuries, ill health, or premature death. but the gains in health reported by the iom were not shared equally among the population of the united states. at the moment, as was also the case in , gains in health status are not shared fairly or equally by all americans. americans with a good education, those who hold high-paying jobs, and those who live in serene and comfortable neighborhoods live longer and healthier lives than those with lower levels of education and income, and those who live in crime infested, overcrowded, and less comfortable and cohesive urban areas (isaacs and schroeder , p. ; bell and standish , p. ; lantz et al. lantz et al. , p. navarro , p. ; satcher , p. ; williams , p. ; metzler , p. ; kilbourne et al. kilbourne et al. , p. berkman and lochner , p. ) . there are several pathways through which social and economic circumstances affect health. those with good educational achievements are more likely to attain higher socioeconomic status than the poorly educated (angel et al. ; barr ; bartley ; mirowsky and ross , p. ) . people of lower socioeconomic status die earlier and are more susceptible to undesirable life events than people on higher socioeconomic levels, a pattern that holds true in a progressive fashion from the poorest to the richest (mcleod and kessler , p. ; adler et al. , p. ; adler and newman , p. ; guralnik et al. , p. ; mcdonough et al. mcdonough et al. , p. . this trend also holds whether one looks at education or occupation (national center for health statistics , p. ; kaplan and keil , p. ). these differences are said to be due to the fact that people of higher socioeconomic status have healthier behaviors and lifestyles than those of lower socioeconomic status. people of higher socioeconomic status are less likely to smoke, and are far more likely to eat healthier foods and to engage in leisure-time physical exercise (national center for health statistics , p. ; pratt et al. , p. s ; giles-corti and donovan , p. ). according to isaacs and schroeder ( , p. ) , as a result of "a sedentary lifestyle and unhealthy eating habits, obesity and the diseases it fosters now characterize lower-class life." poor eating habits and a sedentary lifestyle alone do not explain the differences in health between high and low socioeconomic people. rather, another explanation for the differentials lies in the distribution of income or the income gradient between the low and high socioeconomic groups. in a study of white americans using census data, undertaken by smith et al. ( , p. ) , men earning less than $ , per year were . times as likely to die prematurely as were those earning $ , or more. a similar study of british civil servants conducted about years before the american study showed that when smoking and other risk factors were controlled for, those who were in the lowest employment category were more than twice as likely to die prematurely of cardiovascular disease as were those in the highest employment category (davey smith et al. , p. ) . the fi ndings of these studies have led to the theory that inequitable distribution of income and wealth, or the socalled income and wealth gradient, causes poor health (sen (sen , p. , daniels et al. ; deaton , p. ). as noted above, the relationship between health and income is referred to as a gradient. this terminology emphasizes the gradual relationship between the two variables. health improvements are directly related to improvements in income throughout the income distribution, and poverty has more than a "threshold" effect on health (deaton , p. ) . the us national longitudinal mortality study (nlms) published by the national institutes of health (nih) ( ) showed that the proportional relationship between income and mortality was the same at all income levels, implying that the absolute reduction in mortality for each dollar of income was much larger at the bottom of the income distribution than at the top. apart from income, mortality is also known to decline with wealth, rank, and with social status (marmot et al. (marmot et al. , p. (marmot et al. , (marmot et al. , p. . similarly, studies also show marked differences in life expectancy by race and by geography or people's places of residence. for example, there is a -year gap in life expectancy between white men who live in the healthiest counties or localities and black men who live in the unhealthiest counties (murray et al. , p. ; gittelsohn , p. ; marmot marmot , p. kawachi and berkman ) . the brief discussion in this section points to the effects of numerous, and possibly interrelated, social and economic factors on health. income might affect health just as health might affect income; the distribution of income and wealth might affect health. similarly, education, race, minority status, geography, employment, housing, discrimination and social isolation, nutrition, lifestyle, stress, health practices, and coping skills might affect health. it does not appear to matter very much which of the above factors is stressed, especially since they are more likely to be interdependent than independent. disease risks exist, most often, along a continuum (rose ) . risks are rarely dichotomous. according to lochner ( , p. ) , there is no clear division between risk and no risk with regard to, for example, levels of blood pressure, cholesterol, alcohol or tobacco use, physical activity, diet and weight, etc. this gradient of risk also exists for many social and environmental conditions, such as socioeconomic status, social isolation, occupational and environmental exposure, and air quality. put differently, the numerous studies on the determinants of health that we are unable to fully summarize individually here for lack of space, point to the fact that even though the human and material resources at our disposal, the foods we eat, our levels of education, the houses we live in, the quality of the environments where we live and work, to name but a few, affect every person's health, the effects may vary in direction and scope from person to person, depending on the differences in their unique circumstances. improvement in environmental conditions is an important goal of the us government, as can be inferred from the emphasis on environmental quality outlined in healthy people . that document clearly states that factors in the physical and social environment play major roles in the health of individuals and communities. the physical environment is operationalized to include the air, water, and soil through which exposure to chemical, biological, and physical agents may occur. the physical environment can harm individual and community health, especially when individuals and communities are exposed to toxic substances, irritants, infectious agents, and physical hazards in homes, schools, and work sites. the physical environment can also promote good health, for example, by providing clean and safe places for people to work, exercise, and play ( healthy people , p. ). therefore, the physical environment is perhaps one of the most important factors that should be considered when classifying the health status of an individual (wikipedia ) . environmental factors, such as air and water quality, exposure to pesticides and toxic waste, and housing conditions, have major effects on health and human development. for example, substandard air and water quality have been directly associated with diseases such as cancer, asthma, certain birth defects, and some neurological disorders (grant makers in health , p. ) . similarly, many forms of cancer are associated with dioxin, polychlorinated biphenyls (pcbs), and mercury (friis ) . also, airborne particulate matter, tobacco smoke, and ground-level ozone, have been known to cause asthma attacks in children. exposure to lead, which can be found in peeling paint or in the soil and air in many poor communities, has been associated with impaired cognitive and behavioral development and low birth weight among children born to exposed mothers, and is also known to cause kidney damage (friis ) . in recognition of the danger of environmental contamination, bell and standish ( , p. ) urge communities to act on their behalf to make changes in the policies that affect their physical, social, and economic environments. they state, plausibly, that "policy, place, and community" matter. combined, policy and community can alter or ameliorate the underlying forces that lie at the heart of the determinants of health. for example, they argue that policy determines the behaviors or things that are allowed, encouraged, discouraged, and prohibited. policy also determines whether industrial facilities will be sited near residential neighborhoods, how industrial facilities treat their neighbors; how dense neighborhoods will be; what materials can be used to build houses; who will live in a neighborhood; whether businesses can locate in a neighborhood; and whether there are tax or other incentives available for locating in a neighborhood (bell and standish , p. ). in the developed communities or countries, environmental epidemiologists are concerned about such things as gene-environment interactions, environment-environment interactions, particulate air pollution, nitrogen dioxide, ground-level ozone, environmental tobacco smoke, radiation, lead, video display terminals, cellular telephones, and persistent organic pollutants (pops) that act as endocrine disruptors. exposure to these downstream or proximate environmental vectors (exposures that are closely related in time and space to the ill-effects they cause) affect both health and well-being (encyclopedia of public health ) . in the developing communities, the primary environmental determinants of health are said to involve biological agents in the air, water, and soil that account for most deaths. for example, diarrheal diseases acquired from contaminated food or water, malaria, intestinal parasitic infections, respiratory diseases caused by biological and chemical agents in both indoor and outdoor air, wreak havoc in the developing countries. these environmental hazards take a far greater toll on human life and suffering in absolute terms compared to those environmental vectors of concern in the developed countries (encyclopedia of public health ) . the above environmental vectors that cause havoc in the developing countries also abound in the poor localities of the united states and other developed countries. wealthy people are more likely to live in better homes and locations where they are less exposed to environmental risks than poor people (friis ; mcleod and kessler , p. ; giles-corti and donovan , p. ; shi and singh , p. ; grant makers in health , p. ) . for example, although the rates of asthma have been rising in the country, the disease affects low-income people disproportionately. whereas the national prevalence rate of childhood and adult asthma is put at about %, some african-american communities report about % of children suffering from asthma. also, puerto rican children are reported to have the highest prevalence of active asthma of any us ethnic or racial group. in california, latino children are reported to be hospitalized for asthma at a rate that is % greater than that of white children. obviously, environmental hazards are some of the reasons for these disparities ( healthy people ; joint center for political and economic studies and policylink , p. ; flores et al. , p. ) . despite the gains in environmental quality since the advent of the environmental movement in the s, mainstream environmental policies neglected the problems identifi ed in low-income communities because the inhabitants of those areas lacked the political and economic resources to press for environmental justice. however, since its start around , the environmental justice movement has resulted in the cleanup of hazardous waste sites, the redevelopment of brown-fi elds, the shutdown of incinerators, and the establishment of parks and conservation areas in low-income communities. additionally, in low-income communities, local pollution problems are being addressed, cleaner and more accessible means of public transportation are made available, and wild lands and unique habitats are being protected (faber and mccarthy ) . these changes are due to interest group pressure, the recognition of the externalities associated with environmental degradation, and the value of a clean environment to the health and well-being of all persons, rich and poor. mcginnis et al. ( , p. ) contend that behavior choices constitute the single most important domain of infl uence over health prospects in the united states. lifestyle and behaviors involve many dimensions, including dietary choices, engagement in physical activity, sexual behavior and recreation, including the choice to smoke and to ingest alcohol, the wearing of motor vehicle seatbelts and motorcycle helmets, and other responsible behavior when operating motor vehicles. because lifestyle and behavioral factors are under the control of individuals, the public is very likely to defi ne lifestyle and behavioral health problems as being self-induced. the choices we make with regard to the many dimensions of lifestyle and behavior enumerated above have signifi cant impacts on personal and population health. for example, dietary factors have been associated with coronary heart disease and stroke; colon, breast, and prostate cancers; and diabetes (us department of health and human services ) . similarly, a sedentary lifestyle has been associated with increased risk for heart disease, osteoporosis, dementia, diabetes, and colon cancer (us department of health and human services ) . furthermore, research shows that diets rich in fruits and vegetables, low-fat dairy foods with reduced saturated and total fat, and low sodium diets can lower blood pressure (appel et al. (appel et al. , p. svetkey et al. , p. ; sacks et al. , p. ) . the primary differences between how we perceive behavioral change now from much earlier perceptions is the great awareness that individual behavior occurs in a social context (berkman and lochner , p. ) , be it the place of work or abode, the family, the place of worship, the peer group, the school system, the stage of development, etc. for example, the results from the national youth risk behavior survey (yrbs) demonstrated that numerous high school students engaged in behaviors that increased their chances of dying from motor vehicle crashes, other unintentional injuries, homicide, and suicide. specifi cally, the survey results showed that . % of those surveyed had rarely or never worn a seatbelt during the days preceding the survey; . % had ridden with a driver who had been drinking alcohol; . % had carried a weapon during the days preceding the survey; . % had drunk alcohol during the days preceding the survey; . % had used marijuana during the days preceding the survey; and . % had attempted suicide during the months preceding the survey (grunbaum et al. , p. ) . the authors of the yrbs concluded that "priority health-risk behaviors, which contribute to the leading causes of mortality and morbidity among youths and adults, are often established during youth, extend into adulthood, are interrelated, and are preventable." the examination of the main causes of death in the united states, which we shall shortly discuss in the next section of this chapter, will shed further light on behavioral risk factors. meanwhile, suffi ce it to say that lifestyle and behavioral factors constitute some of the important determinants of health that health policy must seek to address. even though it is agreed that the contribution of medical care to improved health is not as pronounced as the other factors just examined, curative medical care-those practices, technologies, and organizations that society and the medical profession use to cure and rehabilitate the sick-is nonetheless a key determinant of health (blum ; cdc ) . the centers for disease control and prevention (cdc) estimate that only about % of premature deaths in the united states can be attributed to inadequate access to medical care, while the remaining % can be accounted for by individual lifestyle and behaviors ( %), genetic profi les ( %), and social and environmental conditions ( %) (cdc ) . the reason why medical care is the least important determinant of health is because it is reactive, not proactive-it waits for disease and illness to occur before intervening, so to speak. in other words, while individual and population health are somehow associated with having access to curative care, access to preventive services is of greater signifi cance. therefore, health can improve signifi cantly, and the prevalence of disease can decline dramatically, without effective medical care, due to the other determinants of health (sigerist , p. ; mckeown , p. ; banta and jonas , p. ). this knowledge is very likely the reason why williams and jackson ( , p. ) and isaacs and schroeder ( , p. ) advocate the broadening of the concept of health policy to include the other determinants of health that were not usually seriously considered when discussing health policy. this knowledge, too, is the primary reason for this chapter of the book. we can elaborate further on the importance and relevance of the determinants of health by linking them to the ten leading causes of death in the united states. where possible, the analysis will link the incidences of mortality reported in the country that are associated with each, some, or combinations of the determinants of health. table . shows the ten leading causes of death in the united states for and . we present, below, the ten leading causes of death in the country for and in order to attempt to link some of them to treatable or preventable behaviors and exposures. in other words, we shall attempt to show that most of the deaths can be associated with factors that mainly fall under the social, economic, environmental, and lifestyle and behavioral determinants of health that we have just discussed. most of the ten leading causes of death presented above are nongenetic and can be prevented or treated. diseases of the heart, cancers, cerebrovascular diseases or strokes, chronic lower respiratory diseases, unintentional injuries, diabetes, infl uenza and pneumonia, and infection-and high blood pressure-induced nephritis can be curtailed, prevented, or treated. for example, cigarette smoking is linked with an increased risk of heart disease, chronic lower respiratory disease, and cancer; obesity is a major health risk for diabetes, hypertension, coronary heart disease, and some forms of cancer; alcohol causes a wide variety of accidents and injuries, increases the risks for high blood pressure, irregularities of the heart, and stroke; fl u vaccines can minimize infl uenza deaths; and seeking treatment for infections can prevent septicemia. additionally, although there is a genetic basis for nephrosis and nephrotic syndrome, the conditions can occur as a result of infection (such as strep throat, hepatitis, or mononucleosis), use of certain drugs, and diabetes. furthermore, although age and family history are important risk factors for alzheimer's disease, longstanding high blood pressure and a history of head trauma are suspected risk factors for the disease as well mcginnis and foege ( , p. ) identifi ed and quantifi ed the major external or nongenetic factors that contributed to deaths in the united states in . deaths associated with socioeconomic factors and access to medical care, although important contributors to the total deaths recorded in the country, were not included in the study because of the diffi culty quantifying them independent of the other factors reported in the study. about years after the mcginnis and foege study, mokdad et al. ( mokdad et al. ( , p. ) used a similar methodology to quantify the nongenetic factors that contributed to deaths in . the results of the two studies cited above showed that about half of all deaths that occurred in the united states in both and could also be attributed to a small number of largely controllable behaviors and exposures, including tobacco, diet and activity patterns, alcohol, microbial and toxic agents, fi rearms, sexual behavior, motor vehicle accidents, and illicit drug use. the results of the causes of death studies reported by mcginnis and foege and mokdad and his colleagues are consistent with the fi ndings of the national yrbs cited earlier in this chapter. the survey results showed that in the united states, . % of all deaths among youth and young adults aged - years were due only to four causes: motor vehicle crashes, other unintentional injuries, homicide, and suicide. the deaths attributable to these causes among the identifi ed population group were . , , . , and . %, respectively (grunbaum et al. , p. ) . furthermore, substantial morbidity and social problems were said to result from the approximately , pregnancies that occurred each year among women - years (ventura et al. , p. ) , and from the estimated million cases of sexually transmitted diseases (stds) that occurred each year among persons - years (institute of medicine ; eng and butler ) . similar to the studies on the actual causes of death in the united states in and , the yrbs also found that the leading causes of mortality and morbidity among all age groups in the country were related to behaviors that contributed to unintentional injuries and violence, tobacco use, alcohol and other drug use, sexual behaviors that contributed to unintended pregnancies and stds, including hiv infection, unhealthy dietary behaviors, and sedentary lifestyles. in , almost years after the yrbs discussed above, the cdc quantifi ed the death rates among teenagers aged - years between and . not surprisingly, the ten leading causes of death for the teenage population remained constant throughout the period. they were as follows: accidents or unintentional injuries, % of deaths; homicides, % of teenage deaths; suicide, %; cancer, %; and heart disease, %. further analysis showed that motor vehicle accidents accounted for almost three quarters ( %) of all deaths from unintentional injury; and that non-hispanic black males had the highest death rate among all teenagers, with homicide being the leading cause of death for them (minino ) . the determinants of health that have occupied our attention up to this point are not only affected by the broad national and personal factors we have identifi ed but are also affected by broad global or international factors (shi and singh , p. ) . therefore, the rest of this chapter is devoted to examining the infl uences of global factors on the health care system and the health policymaking process. foreign policies involve the political relationships between countries and the outside world. foreign policy development generally concerns the protection of a country's national interests, usually defi ned in terms of security, economic prosperity, and ideological goals (lee et al. , p. ) . increased globalization has led to the broadening of foreign policy concerns to include health. conversely, it is now recognized that international trade and fi nance, migration and population mobility, environmental change or global warming, the emerging and reemerging infectious disease paradigms, natural disasters, and global insecurity or terrorism have clear and observable consequences for human health (kassalow ; mcinnes and lee , p. ; lee et al. , p. ; katz and singer , p. ; campbell-lendrum et al. , p. ; fidler , p. ; macpherson et al. , p. ; labonte et al. ) . we shall briefl y examine how these components of globalizationinternational trade, population mobility, infectious diseases, global warming or climate change, and natural disasters and terrorism-affect countries' health care and policymaking systems generally, and the united states' health care and policymaking systems in particular. we begin with international trade. the principal agents of global international trade and fi nance include such international agencies as the world bank, the international monetary fund (imf), and the world trade organization (wto). it has been reported that the market-biased or effi ciency-oriented austerity policies these organizations promote or sponsor have resulted in reduced expenditures for social programs in developing countries, thereby impairing population health and slowing the advances in literacy, fertility reduction, and improved reproductive health of the women of the developing countries (kinnon , p. ; gray ; watts ) . some specifi c examples of international trade and fi nance policies include the following: trade liberalization or the lowering of tariffs and other barriers to imports that has led to the doubling of the value of world trade from % of world gdp in to % in (world bank ; the reorganization of production and service provision across multiple national borders by multinational or transnational corporations, such as outsourcing or the pursuit of integration into global value chains, resulting in a global labor market (world bank , p. woodall ) ; the conditions attached to world bank and imf loans, and to the rescheduling of loan payments, including structural adjustment programs (saps); fi nancial liberalization, which exposes national economies to the uncertainties created by large and volatile short-term capital fl ows; the signifi cant growth in the world's urban population caused by transnational economic integration; the promotion of export-oriented agricultural development that does not consider the social and environmental consequences of such actions, which result from the pressures on governments around the world to increase export earnings (stonich and bailey , p. ) ; and the promotion and reinforcement of a market-oriented concept of health sector reform that strongly favors private provision and fi nancing (petchesky ; koivusalo and mackintosh , p. ). critics of the above international trade and fi nance policies argue that it is not at all clear that globalization leads to substantial poverty reduction. they point to the large-scale and extreme unequal distribution of wealth and income in the countries that have been identifi ed as "globalizers" witnessing rapidly growing economies. it is argued that even a little redistribution of income through progressive taxation and targeted social programs would go farther in terms of poverty reduction than many years of solid economic growth (jubany and meltzer ; paes de barros et al. ; de ferranti et al. ) . further, it is argued that as countries compete for foreign direct investment and outsourced production, the need to appear business-friendly may limit their ability to adopt and implement labor standards, occupational safety and health regulations, and other redistributive programs (cornia ) ; global integration of production may cause a sharp decline in the wages of, and demand for, low-skilled workers; large amounts of debt limit the ability of many developing and developed countries to meet other human needs related to health, education, water, public safety, sanitation, nutrition, etc.; globalization may lead to an intensifi cation of worldwide social relations which link distant localities in such a way that local happenings are shaped by events occurring many miles away, and vice versa (giddens , p. ) ; much of the urbanization caused by international fi nance and trade policies occurs in countries that have limited resources to provide urban infrastructures; and the emphasis on private fi nancing and provision of health care leads to large-scale underinsurance and uninsurance in both the developed and developing countries (labonte and schrecker , p. ) . globalization and the quest for exports are also blamed for increased smoking and tobacco-related mortality in the developing countries (murray and lopez , p. ) . also noteworthy is the escalation in the sale of weapons, much of it facilitated by western governments. the wars that have raged on and off in sub-saharan africa, latin america, and asia are tragic examples of the ill effects of aggressive weapon sales to these places (mcmichael and beaglehole , p. ) . although the adverse effects of globalization discussed above tend to affect developing countries more than the united states, there are signifi cant adverse consequences of globalization for the united states as well. some of these include the perpetuation and exacerbation of the gap between the rich and the poor, a large public debt profi le that puts signifi cant pressure on social and other safety net policies and programs, the prevalence of uninsurance and underinsurance, job insecurity and reduced wages, the collapse of large manufacturing businesses, increased availability and demand for illicit drugs, and the emergence of new infectious diseases that spread more easily due to increased migration and population mobility (ubokudom and khubchandani , p. ) . for example, american labor unions complain that the north american free trade agreement (nafta) with canada, mexico, and the united states, which came into force on january , , has led to the loss of american jobs. job loss causes stress, loss of income and the fi nancial means to pay for medical care. from the onset, health issues were not at the heart or margins of foreign policy theory or practice for two reasons. first, the protection and promotion of population health did not factor into world leaders' calculations of what "competition in anarchy" (the condition from which foreign policy dynamics fl ow) required of their countries, nor was health for all seriously (as opposed to rhetorically) considered a pathway to a better world. second, those who were engaged in public health did not participate signifi cantly in discussions of foreign policy (fidler , p. ) . therefore, there were only small and nonsubstantial linkages between health and foreign policy (harris , p. ) . actions linking health issues or problems with foreign policy have been strongest when the potential impact on economic prosperity, national security, the environment, and development is severe. this has resulted in attention to health threats that are acute and severe, those that are projected to result in mass casualties, and those that are believed to be geographically widespread. in contrast, long-term health risks, or health risks that cause minor health problems, affect a limited number of people, or are not geographically widespread, attract little attention in relation to foreign policy. in other words, acute epidemic infections and major public health emergencies, such as natural or human-induced disasters, bioterrorism, and chemical and radiation accidents, have received signifi cant attention (fidler , p. ; lee et al. , p. ; katz and singer , p. ) . a few specifi c examples of "attention-receiving" public health problems include the previously unknown human immunodefi ciency virus/acquired immunodeficiency syndrome (hiv/aids) which appeared in the united states in the early s; the hantavirus, believed to have originated in korea; eastern equine encephalitis, which is found in the eastern and north-central united states, canada, parts of central and south america, and the caribbean islands; western equine encephalitis, which occurs primarily in the western and central united states, canada, and parts of south america; the polio virus that is believed to have originated in india in ; the spread of severe acute respiratory syndrome (sars) from china in ; and the outbreak of the deadly h n -swine flu-infl uenza believed to have originated in mexico (cdc ; shi and singh , p. ; friis , p. ) . in summary, many health problems, particularly infectious diseases, are widely recognized as global concerns that cross national and international boundaries. consequently, countries frequently include in their foreign policies strategies on these diseases that have the potential to threaten their domestic interests. this is likely to lead to higher prioritization, more attention, greater political support, and more funding. for example, in the united states, projections of the impact of hiv/ aids on the workforces of many countries, and the prevalence of hiv among military personnel in several regions of the world, contributed to the determination that hiv/aids was a security issue. similarly, awareness of the havocs caused by previous infl uenza pandemics and the economic impact of the small and short outbreak of sars led to serious preparations by the who and its member states for the next infl uenza pandemic (katz and singer , p. ) . this understanding has led to many international agreements covering health and the environment, including the agreement on sanitary and phytosanitary measures, the international standards organization's classifi cation system for food labeling, the un framework convention on climate change, and the kyoto protocol, to name a few. data from the national aeronautics space administration (nasa) show that the earth's surface has warmed by about . °c between january and november . that period was reported to be the warmest january-november in the nasa goddard institute for space studies (giss) analysis, which covers years. the period was only a few hundredths of a degree warmer than , so it is possible that the fi nal giss results for the full year, , would be warmer or in the same range as . further, the available data also show that the earth's surface has warmed by more than . °c over the past century and by about . °c in the past decades (nasa ) . therefore, contrary to frequent assertions that global warming has slowed in the past decade, global warming has proceeded in the decade that ended in just as fast as it did in the prior decades (nasa ) . the health hazards posed by climate change and global warming are inequitable, diverse, global, and probably irreversible over human time scales (patz et al. , p. ; campbell-lendrum et al. , p. ) . they include increased risks of extreme weather, such as fl oods and storms, fatal heat waves, long-term drought conditions in many areas of the world, surface water pollution and groundwater contamination, the melting of glaciers that supply freshwater to large population centers, salination of sources of agricultural and drinking water, increased rates of water extraction that may precipitate declines in supply, and creating a conducive environment for the global killers that are very sensitive to climatic conditions, such as malaria, diarrhea, and protein-energy malnutrition (campbell-lendrum et al. , p. ; friis , p. ) . as we noted under the actual causes of death, these three global killers cause many deaths in the united states; they are also said to account for about three million deaths worldwide each year (who ) . the relationship between migration, population mobility, and health is receiving renewed attention due to the emerging and reemerging infectious diseases that were discussed previously in this section. the health of both legal and illegal migrants to any country are affected by the determinants of health discussed earlier in this chapter, as well as by the risks that are present in their country of origin or that arise from the migration process itself (macpherson and gushulak , p. ) . this is very true of the united states where a signifi cant portion of the annual population growth is due to migration. the effects of population mobility and migration on the country's health care system and the provision of health services are reported daily in the pages of newspapers. first, there is likely to be increased demand for services due to population growth, whether that growth is due to increased fertility rates or migration. for example, the exponential growth in medicaid expenditures in states that border mexico are said to be due to the increased demand for medical services by illegal immigrants as well as by the medical needs of an aging population. second, offi cials of the states that share boundaries with mexico complain about increased violent crimes committed by illegal immigrants, crimes that take a heavy toll on population health and health care expenditures. third, increased migration compels more health services planning, infrastructure maintenance, development and training of a diverse medical workforce to cater for the increasingly diverse population, and the establishment of public health programs for health promotion, health protection, and disease prevention (macpherson et al. , p. ; cohen et al. , p. ) . and, fourth, the opinion pages of newspapers carry citizens' letters that attribute the success of previous terrorist campaigns to the nearly open border policy the united states maintained prior to september , ( / ). since the / attacks, border security and entry visa requirements have been tightened. border control measures are now centered on inspecting and excluding goods, vessels, and people that pose serious health or terrorist threats to the united states. other countries have similar measures. the world has changed. indeed, the world has changed signifi cantly. while most people are actively planning on how to make their lives better, a few others are actively planning on how to destroy lives and settle political and ideological differences through acts of violence. no place and people are immune from the threats of violence, terrorism, and natural disasters. in the past or years, the united states has experienced disasters that have led to a rethinking of how to keep the population safe. the terrorist attacks in the united states on september , , an unsuccessful attempt to initiate an anthrax epidemic in october , and the devastation caused by hurricane katrina of the atlantic hurricane season led to signifi cant loss of lives and property and revealed defi ciencies in the public health and emergency response systems in the country. because of both underfunding and understaffi ng, and perhaps because the changes that have taken place in the world were not anticipated, the public health system was unable to develop or implement a comprehensive program of preparedness, prevention, response, and recovery (us general accounting offi ce ) . following the disasters, state, local, and federal public health agencies began to identify weaknesses in the nation's public health infrastructure and to reevaluate existing disaster response plans (baker and koplan , p. ). the shortcomings revealed in the nation's disaster response plans elevated public health to an important national instrument for anticipating and dealing with terrorism, infectious disease outbreaks, and natural disasters. the guidance on responses to chemical, biological, radiological, nuclear, and explosive threats provided by the cdc, and by other national organizations and universities, helped individual state governments to develop statewide policies that took their unique concerns into account (ziskin and harris , p. ; shah shah , p. gebbie and turnock , p. ) . public health plans to deal with terrorist threats, infectious diseases, and natural disasters now involve public health agencies at the federal, state, and local levels of government; other government and private agencies, such as the departments of justice and defense; the food and drug administration; private, public, and nonprofi t hospitals, clinics, and nursing homes; private and public practitioners, such as nurses and physicians; blood supply organizations, such as the american red cross; police and fi re departments; and individuals and groups throughout the country. as would be expected, expenditures for government public health activities, while still low relative to expenditures for medical care, rose from $ billion in to about $ . billion in , an increase of . % from (centers for medicare and medicaid services (cms) ) . it remains to be seen if this enthusiasm for public health, demonstrated by increased funding since , can be sustained. the law that is used as the basis for most of the new emergency preparedness measures is the homeland security act of . in addition to the strengthening of the public health infrastructure, the law also called for improved inspections of food products entering the united states. it calls for better measures to contain attacks on food and water supplies, to protect vital infrastructures, such as nuclear facilities, and to track biological materials anywhere in the country. further, the provisions of the law have been used to justify tough and controversial interrogation techniques, such as waterboarding. similarly, presidential executive order , signed by george w. bush on april , , authorizes the apprehension, detention, or conditional release of individuals with suspected communicable diseases, such as sars, cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, and viral hemorrhagic fevers such as ebola (the free dictionary ) . in summation, international trade and fi nance, infectious disease epidemics, global warming and climate change, population mobility, and natural disasters and terrorism signifi cantly affect the united states health care delivery and policymaking systems. in addition, medical technology and us health care professionals and consumers are also affected by global factors. for example, because the united states is widely believed to be the world leader in the development and utilization of high-technology medical protocols, foreign dignitaries come here for specialty care. also, nurses and foreign medical school graduates (fmgs) move to the united states to acquire licenses to practice in the country. this so-called brain drain causes shortages of medical practitioners in the developing countries and alleviates some of the shortages in the health professional shortage areas of the united states. furthermore, telemedicine allows us physicians to transmit radiological images to other countries where they are analyzed at lower costs. on the other hand, us consulting pathologists and radiologists provide their services to other parts of the world. also, advanced medical equipment and supplies that are abandoned here a few years after deployment are shipped to the developing and less technology-intensive developed countries at low costs. the high costs paid by us consumers are used to subsidize the low costs paid by the developing countries (ubokudom and khubchandani , p. ) . this chapter has identifi ed the impacts of physical, social, cultural, and global factors on health and health policymaking. health can be defi ned under the medical or wellness models. the health status of the us population, or the population of any other country for that matter, is largely determined by factors that have important physical, social, and economic dimensions. these include preventive medicine, genetic disposition, social and economic circumstances, environmental conditions, lifestyles and behaviors, and medical care. these determinants of health are associated, in various degrees, with the real or actual causes of death in the country. research demonstrates that most of the deaths in the country are attributable to a small number of largely controllable behaviors and exposures, or due to factors that fall under the preventive, social, economic, environmental, and lifestyle and behavioral determinants of health. these determinants of health are not only affected by the broad national and personal factors identifi ed in the chapter, they are also affected by global or international factors, including trade and fi nance, outbreaks of infectious diseases, climate change, natural disasters, and the threats of terrorism and population mobility. but even though most of the deaths in the country are the result of social, cultural, economic, environmental, and global factors, medical care is also an important determinant of health that cannot be ignored. an insurance card is one of the important factors that infl uence access to medical services. consequently, the next chapter examines demographic factors, most especially americans' ability to access medical services, and the disparities in health among segments of the population. socioeconomic inequalities in health: no easy solution socioeconomic disparities in health: pathways and policies poor families in america's health care crisis a clinical trial of the effects of dietary patterns on blood pressure in why are some people healthy and others not? strengthening the nation's public health infrastructure: historic challenge, unprecedented opportunity in jonas's health care delivery in the united states health disparities in the united states: social class, race, ethnicity and health unemployment and ill health: understanding the relationship communities and health policy: a pathway for change relationship of physical health status and health problems health and ways of living: the alameda county study social determinants of health: meeting at a crossroads planning for health pathways to health: the role of social factors the role of medical care in determining health: creating an inventory of benefi ts genes, dreams, and realities global climate change: implications for international public health policy healthy people: the surgeon general's report on health promotion and disease prevention national health expenditure projections priorities among recommended clinical preventive services the case for diversity in the health care workforce policy reform and income distribution is inequality bad for our health explanations for socioeconomic differentials in mortality: evidence from britain and elsewhere the social context of science: cancer and the environment policy implications of the gradient of health and wealth inequality in latin america & the caribbean: breaking with history? the hidden epidemic: confronting sexually transmitted diseases green of another color: building effective partnerships between foundations and the environmental justice movement the health of latino chindren: urgent priorities, unanswered questions, and a research agenda essentials of environmental health the public health workforce, : new challenges the consequences of modernity socioeconomic status differences in recreational physical activity levels and real and perceived access to a supportive physical environment on the distribution of underlying causes of death social determinants of health false dawn: the delusions of global capitalism youth risk behavior surveillance-united states educational status and active life expectancy among older blacks and whites marrying foreign policy and health: feasible or doomed to fail? united states department of health and human services (usdhhs) deaths: leading causes for institute of medicine (us) committee on health and behavior: research, practice, and policy. health and behavior: the interplay of biological, behavioral, and societal infl uences class-the ignored determinant of the nation's health breathing easier: community-based strategies to prevent asthma the achilles' heel of latin america: the state of the debate on inequality , fpp - . ottawa, canada. canadian foundation for the americas (focal) regional obesity and risk of cardiovascular disease: the framingham study socioeconomic factors and cardiovascular disease: a review of the literature why health is important to u.s. foreign policy health and security in foreign policy neighborhoods and health overview: a current perspective on twin studies of schizophrenia fundamentals of genetic epidemiology advancing health disparities research within the health care system: a conceptual framework world trade: bringing health into the picture statement on the politicization of evidence-based clinical research in commercialization of health care: global and local dynamics and policy responses globalization and the social determinants of health: the role of the global marketplace (part of ) socioeconomic factors, health behaviors, and mortality: results from a nationally representative prospective study of u.s. adults bridging health and foreign policy: the role of health impact assessments religion and health: is there an association, is it valid, and is it causal? benefi ts and harms of prostate-specifi c antigen screening for prostate cancer: an evidence update for the u.s. preventive services task force health and foreign policy: infl uences of migration and population mobility human mobility and population health: new approaches in a globalizing world health inequalities among british civil servants: the whitehall ii study inequalities in death-specifi c explanations of a general pattern the spiritual history religion and depression: a review of the literature religious involvement and mortality: a meta-analytic review income dynamics and adult mortality in the united states the case for more active policy attention to health promotion actual causes of death in the united states health, foreign policy and security the role of medicine: dream socioeconomic status differences in vulnerability to undesirable life events the changing global context of public health septicemia social determinants of health: what, how, why, and now social patterns of distress mortality among teenagers aged - years: united states actual causes of death in the united states screening for bladder cancer: u.s. preventive services task force recommendation statement hereditary colorectal cancer: from bedside to bench and back patterns of mortality by county and race: - . cambridge, ma: harvard center for population and development studies alternative projections of mortality and disability by cause - : global burden of disease study (phs) - ), - . national institutes of health. . a mortality study of . million persons by demographic, social, and economic factors: - follow-up what we mean by social determinants of health meeting the millennium poverty reduction targets in latin america and the caribbean letter: linkage of familial combined hyperlipidaemia to chromosome q -q impact of regional climate change on human health global prescriptions: gendering health and human rights levels of physical activity and inactivity in children and adults in the united states: current evidence and research issues nephrotic syndrome: nephrosis alzheimer's disease; senile dementia-alzheimer's type (sdat) retrieved biologic-marker studies in alcoholism factors infl uencing the view of patients with gynecologic cancer about end-of-life decisions the strategy of preventive medicine successful aging effects on blood pressure of reduced dietary sodium and the dietary approaches to stop hypertension (dash) diet commentary: include a social determinants of health approach to reduce health inequities development as freedom the formation of the emergency medical services delivering health care in america: a systems approach socioeconomic differentials in mortality risk among men screened for the multiple risk factor intervention trial: i. white men resisting the blue revolution: contending coalitions surrounding industrial shrimp farming health services research: a working model effects of dietary patterns on blood pressure: subgroup analysis of the dietary approaches to stop hypertension (dash) clinical trial rethinking mckeown: the relationship between public health and social change severe acute respiratory syndrome (sars) poor diets, little exercise leading cause of preventable illness and deaths world development report : workers in an integrating world an introduction to epidemiology the ecology of health policymaking and reform in the united states of america united states department of health and human services (usdhhs). . the surgeon general's report on nutrition and health physical activity and health: a report of the surgeon general bioterrorism: public health response to anthrax incidents of section : overview of u.s. preventive services task force structure and processes trends in pregnancy rates for the united states, - : an update epidemics in history: disease, power and imperialism unhealthy societies: the affl iction of inequality social sources of racial disparities in health socioeconomic differences in health: a review and redirection men's health: chronic lower respiratory diseases world health organization (who). . preamble to the constitution of the world health organization as adopted by the international health conference state health policy for terrorism preparedness key: cord- -ldkjqco authors: nan title: news date: - - journal: aust vet j doi: . /avj. sha: doc_id: cord_uid: ldkjqco nan r eports of psychological distress, occupational stress and burnout and an increased risk of suicide in the veterinary profession are urgent reminders that veterinary schools, professional organisations and also employers should continue to address these issues. , managerial aspects of the job, long working hours, heavy workload, poor work-life balance, difficult client relations and performing euthanasias have been consistently associated with increased levels of occupational stress. chronic work stress can lead to emotional exhaustion and burnout. female veterinarians, younger veterinarians and those working on their own are at greatest risk of stress and mental health difficulties. , results from a recent observational study conducted at veterinary practices in canada suggest that team effectiveness can improve an individual team member's job satisfaction and offer protection against stress and burnout. the study found that % of veterinary team members were considered to be at a high risk of burnout. the study recommendations are that practice managers: • ensure all team members are kept abreast of changes in the clinic and given opportunities to provide suggestions to improve patient care and client service • recognise team members for their contributions • provide all staff with adequate resources and guidance to complete their jobs in a meaningful fashion and provide opportunities for growth and professional development • ensure all team members have clearly defined roles and are given autonomy to make decisions consistent with their position in the practice • encourage colleagues and supervisors to provide guidance and social support to help team members develop coping skills • take steps to create and maintain a positive work environment -this may include addressing conflicts among co-workers, ensuring all employees are treated equally and fairly, promoting civility and collegiality • consider current staff numbers and individual workloads to prevent excessive workload. providing communication and coping skills training and improving cognitive skills for young professionals may also help to decrease depression, anxiety, stress and burnout. if you are concerned that a colleague, close friend or family member is experiencing mental health difficulties, try talking to them in a supportive manner and encourage them to consult their gp or mental health professional. a -hour telephone counselling service is available for ava members on . this service can also arrange a counsellor to attend veterinary workplaces to help support staff after a traumatic incident. lifeline is another excellent support option: . dogs suffering from osteoarthritis need proven relief from pain and infl ammation. julia nicholls, president a s i write, our policy advisory council (pac) is voting on policies that are under review or newly drafted. so it may be a good time to reflect on why we have these polices and how they are written, as there has also been some debate about the function and process of the pac. ava policies are used as a reference point for the public, the media and members. many of our members sit on external boards and committees and the policies are key documents in these forums. i recently had to respond to a good question as to why our policy on equine dentistry did not completely align with the recommended key principles for veterinary practice acts in australia, which were recently circulated to members (www.ava.com.au/node/ ). the crux of this is that the policy reflects an ideal world, but the veterinary practice acts, which are written for the protection of the public, reflect current reality. we have other policies that do not align with those of key stakeholders or with current legislation. this is healthy and reflects our independence and the democratic process. the ava has approximately policies and position statements. subjects range from live animal export to genetic defects in domestic animals, and from puppy socialisation to cane toad euthanasia. position statements replace policies where there is a significant diversity of opinion among members. many policies reflect our stance on animal welfare issues and this is something to be proud of. the pac consists of a representative from every division and special interest group and meets once a year face-to-face but engages in healthy debate online all year. the full process of policy development may seem long-winded to an outsider. an initial draft is created by a working group and is then discussed by all the councillors until the majority are happy that the policy is suitable to go to all members for comment. members have a chance to comment on draft policies twice each year. the councillors work very hard to gain consensus from the members and to work with each other to get a policy ready for the vote. the october voting round is an electronic vote for policies that have been discussed online or have been out for general member comment. councillors vote whether to move each policy to the next stage in the process, send it back to a working group or abandon it altogether. anything requiring more debate is referred to the face-to-face meeting in may. the final sign off is by the ava board. the structure of the ava's policies is important. they should start with a short statement suitable for a media release or sound bite and then have a section on the underlying philosophy, the evidence and some scientific references. operational matters or procedures linked to the policy are usually included as guidelines. each policy undergoes regular review to maintain currency. some are deleted and others added as the environment changes. the policy compendium is a living document and something that is the envy of other veterinary associations. it is hard to see any shortcuts that would improve the process for member involvement. yet situations occur where we have no policy to fall back on. in the world of the -hour news cycle, topics arise that require an immediate response or at least one faster than the formal policy development process. the changes to higher education funding are a case in point. we do not have a policy on this, but it was clear that the proposed changes pose a threat to the future viability of our profession. we believe that we have to oppose this government policy shift, so we are, hopefully with your support. another example is where we have a policy but it is silent on the particular aspect of the topic under debate. in these circumstances, the board or a consultative group delegated by the board will arrive at an official position in keeping with the spirit of our policies. ideally, a policy will eventually flow from experiences like these. members and board directors have asked a range of questions about our policy development process in recent years: • should there be more scanning and identification of futureproofing policies? pet insurance is an increasingly important element of economic sustainability for many members. it means that clinical veterinarians can provide the best care for their patients and clients, regardless of the cost. unfortunately, there have been a number of teething problems with policies and claims, which led us to form a pet insurance taskforce in . the taskforce's role is to work with the profession and pet insurance companies to identify and then address issues of concern for veterinarians, pet owners and the insurance companies. our ultimate goal is to ensure that pet owners and veterinarians have confidence in pet insurance as a trustworthy and valuable element of pet care. one of the key activities the taskforce has undertaken is to develop a veterinarians guide to pet health insurance. the guide includes: • general information on what pet insurance is (and isn't) • useful facts about the australian market • reasons why more clients don't use pet insurance • techniques for making pet insurance work in your practice and for your clients. it also includes our guidelines for promoting pet insurance, your legal obligations, and what you can and can't say when talking to clients. we've heard from many members who are confused about this area, and the guidelines provide some much needed clarity. a veterinarians guide to pet health insurance is available for download now from the ava website: www.ava.com.au/node/ . on the back of member a survey conducted earlier this year, the taskforce is now gathering more detailed feedback including case studies from members at conferences and other forums. the feedback highlights several areas we believe could be addressed to remove barriers to take-up of pet insurance in australia, including: • the need for a cooling off period so that the pet owner can withdraw from an insurance policy if they are dissatisfied with the exclusions • the need for clearer terms and conditions, and explanations of any exclusions at the time of policy uptake • removing policy exclusions for pre-existing conditions based on entire body systems and unrelated to previous conditions -for example, removal of a toe lump cannot be considered a pre-existing condition just because a dog had a superficial skin infection a year before • making it easier for clients to know if their policy provides cover for particular treatments and diagnostic tests • an improved review of disputed claims by australianregistered veterinarians -we think that an industry review panel of ava members would offer an alternative pathway for appeal to the financial industry ombudsman • moving to electronic submission of claims, and making interactions with the insurers more efficient for veterinarians. we're looking forward to engaging with the insurance companies over these and other issues in the coming weeks. we'll keep you up-to-date with any new developments, and we also plan to develop some more educational resources for veterinarians shortly. with changes to the way the insurance policies and claims process works, we anticipate that more and more pet owners will choose to insure their pets, resulting in more treatment options. it will also mean that veterinarians are working with a system that supports good outcomes for all involved -pets, owners and veterinarians. fun is like life insurance; the older you get, the more it costs. international veterinary, biomedical and business journals at your fingertips vet ed library: www.ava.com.au/library as a vet, you are used to handling your patients with care and understanding, (especially if their bite is worse than their bark). at boq specialist, we adopt the same approach. we've spent nearly years working closely with vets and we've come to know your world as well as we do our own. we know your idiosyncrasies and we can anticipate your needs. so, unlike a conventional bank, we've developed products and services that are carefully designed to meet your business and personal banking requirements. when you call us, you'll always feel you are dealing with one of your own breed. crayfish plague is caused by a water mould, aphanomyces astaci. its native hosts are north american freshwater crayfish and although it produces some minor pathology, does not usually cause death. however, in naïve crayfish (never exposed to the pathogen), the disease causes death and effectively exterminates native crayfish from infected waters in as little as a couple of weeks. historically, north american crayfish were first introduced into europe in the late s for culture and fishery purposes. they carried crayfish plague with them. crayfish plague travelled around europe, with american crayfish that were translocated into european waterways. however, once crayfish plague was introduced to a country, it would also spread rapidly via contaminated fishing gear and water. crayfish plague continues to spread to previously unaffected areas of europe. the effect was severe in areas with a culture of consuming crayfish, particularly scandinavia. national declines in crayfish populations vary from % to % and lakes where crayfish were eliminated became overgrown with aquatic plants. in finland, the estimated cumulative direct loss from crayfish plague over the past years is € million. australia's freshwater crayfish fauna is diverse, with over described species, including a large number that are rare and endangered. crayfish play a crucial role as predators, herbivores and in breaking down detritus in freshwater ecosystems, and are often the largest animals in australian mountain streams. australian crayfish can be split into two broad groups: spiny and smooth-shelled crayfish. spiny crayfish are slow growing, have very large claws and usually prefer clear, cool water. because of their low meat yield and slow growth, they are not farmed. they are important fauna of streams where habitat is suitable, and many have highly restricted distributions, low fecundity and are listed as endangered. the best known of the spiny crayfish is the murray river cray (euastacus armatus). smooth-shelled crayfish include commercially and recreationally important species such as marron (cherax cainii), redclaw crayfish (cherax quadricarinatus), and the ubiquitous 'yabby' (cherax spp.). marron, redclaw and yabbies are farmed in queensland, new south wales, south australia and western australia. marron are primarily farmed in western australia and south australia. annual production varies, but in - it was valued at a$ . million and a$ , , respectively. redclaw production in queensland has declined over the past years and is now valued at a$ , . yabby production for food is limited, mainly from farms in western australia ($ , ) and new south wales ($ , ). redclaw and yabbies have been translocated (legally and illegally) for recreational fishing. many species have substantial cultural importance, and have been a source of food for indigenous people for millennia. crayfish are 'keystone species' in aquatic environments, acting as major processors of organic materials, facilitating the release of energy and nutrients, turning over substrates and aerating soil, and can reach very high biomasses in some systems. some smooth-shelled crayfish are remarkably persistent in dry environments and can survive drought in deep burrows for extended periods. aphanomyces astaci spreads by means of motile zoospores released from mature filaments in infected crayfish. the zoospores are attracted to crayfish cuticle, and the filaments penetrate immediately. zoospores can remain motile for up to days and cysts can survive for weeks (in distilled water). zoospores can re-encyst three times if they do not encounter a host. it is recommended to wait months before attempting to re-stock waters in which crayfish have been killed by crayfish plague, to allow all zoospores to die out. crayfish plague is also spread via contaminated fishing equipment or zoospores in water. american crayfish, including red swamp crawfish (procambarus clarkii) and signal crayfish (pacifastacus leniusculus) are tolerant of infection. they can remain carriers for life, and may exhibit little or no sign of infection. until recently, crayfish plague was only known in temperate to cool climates, but a spanish strain is active at temperatures of - °c. the strain that affects the invasive red swamp crawfish can sporulate at temperatures up to . °c. red swamp crawfish have established in japan, china and taiwan, and populations are sometimes maintained in ornamental fish outlets in the region. thus there is potential for spread of the pathogen throughout the region, either in contaminated water or with live or dead crayfish. freshwater crabs are susceptible to crayfish plague and may act as reservoirs for the pathogen. the chinese mitten crab (eriocheir sinensis) and the european crab (potamon potamios) are both susceptible to infection with crayfish plague. the chinese mitten crab is listed as one of the most invasive species on the planet and has established successfully in europe and north america. australia has very rich and diverse freshwater crab fauna. if infected chinese mitten crabs established in australia, their extensive migration habits (migrating upstream from estuary spawning grounds) could spread crayfish plague inland to crayfish and crab populations. australian crayfish are known to be highly susceptible to crayfish plague. eight species of four genera (including yabbies, cherax destructor) of australian crayfish were experimentally exposed to zoospores of a. astaci. they showed limited or little effective host response to invading filaments. the usual response of crayfish to infection is encapsulation and melanisation of invading filaments. redclaw crayfish and marron have been introduced into many countries for farming purposes. in late , crayfish plague was detected in farmed redclaw crayfish in taiwan. it was detected in five widely spread locations, four of which experienced % mortality, while one experienced % mortality and % morbidity. pathology was not described in the report. as demonstrated by its ability to infect multiple crayfish species, chinese mitten crabs and european crabs, crayfish plague is not very species-specific and could potentially infect most or all australian freshwater crayfish and crab species. it can cause disease and death in crabs, although the effects are not as immediate or dramatic as in crayfish. often the first sign of crayfish plague is the sudden mass death of crayfish in a water body. however, some symptoms do appear, including behavioural changes and external signs. affected crayfish may become active in the day and appear uncoordinated and lethargic. whitish areas in the muscle may be visible through the cuticle under the tail. at very low temperatures (< °c) effects may be slower to emerge, and the disease may be chronic rather than lethal in susceptible species. when american crayfish species (i.e. tolerant of infection but carry it) become infected, the shell may develop dark patches, as the reaction by crayfish to damage is to lay down melanin around the pathogen. these patches are easiest to see on the underside along the abdomen. the identification field guide to aquatic animal diseases of significance to australia provides details of clinical signs and diagnosis for crayfish plague. the aquavetplan disease strategy manual for crayfish plague provides details on gross and clinical signs of the disease. crayfish plague should be differentiated from other possible causes of mass death, such as insecticide poisoning. pcr techniques for detection of the pathogen have been developed. there is an australian and new zealand standard diagnostic procedure detailing methods for diagnosing crayfish plague. the oie manual of diagnostic tests for aquatic animals also provides details on diagnostics to confirm the presence of the pathogen. australian freshwater crayfish are known to be susceptible to crayfish plague fungus. freshwater crayfish are important and dominate in many australian ecosystems, and many species are rare or threatened. many species have restricted distributions, so could become extinct very rapidly if exposed to the disease. crayfish are the basis of an aquaculture industry, as well as supporting recreational and cultural fisheries. the potential consequences of entry of this disease into australia could be severe. the outbreak in taiwan is the first reported case of australian native crayfish being naturally infected by a. astaci and demonstrates the high susceptibility of this tropical crayfish to the pathogen. it caused very high mortalities, suggesting that a similar outbreak in australia could have devastating consequences. some strains of crayfish plague fungus are temperate but others transmit in temperatures up to . °c, suggesting that crayfish plague could infect large areas of australia. american crayfish are widespread in asia. they are regarded as pests in some countries, and until recently crayfish plague had not been reported from asia. the report from taiwan indicates that plague is present and could, potentially, be widespread in the region in feral populations of north american crayfish or chinese mitten crabs. australia has import conditions to restrict the entry of freshwater crayfish or crabs for both environmental and biosecurity reasons. these conditions limit the risk of entry of crayfish plague into australia. however, vigilance for diseases should always be maintained. if an exotic disease is suspected, please call the disease watch hotline for advice and assistance. brett herbert australian government department of agriculture comment on this article at www.ava.com.au/ r abies is present in more than countries across the world, causing more than , human deaths each year, almost all of them in africa and asia and many of them young children. although rabies can infect all warm-blooded animals, the most important source of human infection around the world is an infected dog bite or scratch. australia is one of the few countries that claims freedom from the disease, but as the rabies virus spreads in nearby countries, it is becoming more likely that it will eventually reach our shores. honorary associate professor at the university of sydney, dr helen scott-orr, has been involved in rabies programs in flores, as well as early response and control programs when rabies was first diagnosed in bali in . "rabies is a terrible and terrifying disease when it occurs. it exists in canine populations on several indonesian islands close to our northern shores. in recent years there have been outbreaks on eastern islands, including bali, flores, ambon and the tanimbar islands, which have increased the risk of the disease entering australia. "if it were to reach our border, the most likely place for an incursion is northern australia and the most likely scenario is an illegally imported, infected animal arriving by boat, " dr scott-orr said. dr ted donelan is president of animal management in rural and remote indigenous communities (amrric), which delivers animal health programs in rural and remote aboriginal and torres strait islander communities. dr donelan says that people in isolated indigenous communities are most at threat from a rabies outbreak. "large portions of the northern australian coastline are very sparsely populated. there are significant populations of semi-free-ranging camp dogs, dingos and other wild dogs in and around these communities. if these dogs became infected, they would pose a huge threat to the health and safety of the aboriginal and torres strait islander people living in those areas, " dr donelan said. the australian government has been active in rabies preparedness and prevention. the minister for agriculture, barnaby joyce, recently said, "the work offshore, at our borders and on shore -including the department's engagement with indigenous communities in northern australia as part of the northern australia quarantine strategy (naqs) -is vitally important to ensuring australia maintains its freedom from rabies and other exotic diseases. " since , the department of agriculture has been working in partnership with the indonesian ministry of agriculture to improve the management of emerging infectious diseases. the australia indonesia partnership for emerging infectious diseases is funded by the australian government, with a$ million allocated to developing a more integrated veterinary service capable of preventing, detecting and controlling important endemic and emerging infectious diseases. dr scott-orr and dr donelan agree that the naqs is doing a great deal of work on rabies surveillance, education and preparedness to prevent its introduction to australia. they also believe that australia's ongoing work with neighbouring countries is playing an important part in our protection from the deadly disease. "spending resources on helping our neighbours control rabies helps reduce the risk to australia. it also helps build the pool of professionals with experience in fighting an outbreak, " dr donelan said. preventing the spread of rabies is best achieved through vaccination. dr scott-orr says the most universal knee-jerk reaction from authorities is to kill dogs, but this has proven to be ineffective in containing the virus. "in new incursions, it often spreads insidiously for several months in the dog population before one or more human deaths occur, causing panic. the way to control rabies is to vaccinate dogs. the target for control is at least % of dogs vaccinated every year with a vaccine that has a -year duration of immunity. in addition to this, preventing rapid turnover of the dog population by fertility control is strongly advisable, " dr scott-orr said. • rabies is a vaccine-preventable viral disease that occurs in more than countries and territories. • infection causes tens of thousands of deaths every year, mostly in asia and africa. • % of people who are bitten by suspect rabid animals are children under years of age. • dogs are the source of the vast majority of human rabies deaths. • immediate wound cleansing and immunisation within a few hours after contact with a suspect rabid animal can prevent the onset of rabies and death. • every year, more than million people worldwide receive a post-exposure vaccination to prevent the disease -this is estimated to prevent hundreds of thousands of rabies deaths annually. within australia, dr donelan is encouraging veterinary practitioners who regularly visit remote communities to provide dog health programs to be more proactive in rabies preparedness. "relationships are everything in working with indigenous communities and people who are known, trusted and respected by the locals are far more likely to be given information about sick dogs and gain their cooperation with control measures and vaccination programs, than are outsiders. there is often a healthy mistrust of authority, stemming from experience that usually the prime goal of dog 'management' is to kill the dogs, " dr donelan said. both dr scott-orr and dr donelan advise veterinarians to consider getting vaccinated against rabies for personal protection and to enable them to assist in an outbreak if one was to occur. amrric is currently establishing a register of rabies-vaccinated practitioner members currently servicing or prepared to volunteer in northern australia. "the prevalence of the closely related australian bat lyssavirus (ablv) in both flying foxes and some insectivorous bats, with three human and two equine fatalities recorded, presents another reason for australian vets to consider being vaccinated against rabies. ablv has been found in all states except tasmania and the act, " dr scott-orr said. the media space is becoming more competitive, with more pressure on fewer journalists to file stories in a shorter space of time and when big stories overtake the news, such as the recent terrorist threat, these pressures intensify. total times the ava and its spokespeople feature in the media each year. ava news is not only covered in print, radio and television but increasingly online as well. in fact, between january and september this year, % of our media coverage appeared in online news sites. this reflects people's demand for immediate, up-to-date news and growing preferences to receive information from online sources. you can view some of the online news coverage we've received on the ava website at www.ava.com.au/news- . the ava media program involves identifying and telling positive stories to raise the ava's profile and promote the veterinary profession. the topics we cover include topical policies, response to disease outbreaks and the advocacy work the ava does to support our five strategic priorities. an example of coverage from our advocacy work is the higher education reforms campaign where media coverage has supported our efforts to communicate our position to decision makers in person. significant media coverage was received on this issue. julia nicholls conducted several interviews about the impact the reforms would have on veterinary students and the profession. the story was covered in the sun herald, the sunday age and the sunday canberra times. flow on coverage included wsfm, ue in sydney, ec bega and pr perth, as well as the rural report on abc online. a successful program of stories throughout the year for many of our special interest groups has helped maintain our media profile. these stories have covered heat waves, tick paralysis, parvovirus, behavioural issues, farm safety, dental health, distemper, heartworm, parvovirus, horse heart murmurs, hendra virus, bvdv, pollen, snake bites and swooping magpies. you can view all the ava media releases on the website at www.ava.com.au/mediareleases. ava members also have regular pet advice columns in the west australian and the adelaide advertiser, and a weekly pet radio segment on nm muswellbrook. although stories focussing on companion animals tend to be popular with the media, we continue to increase our influence in the rural media and promote the great work veterinarians do with producers and livestock.  % pets  % livestock  % equine  % legislation / advocacy  % other media releases have been distributed throughout the year to promote sig and division conferences. the publicity program for the ava annual conference was a great success this year and generated media hits. one of the biggest drawcards was the media conference on antimicrobial resistance, which generated more than media hits alone, including radio national and abc radio stations around australia. a panel of experts, who presented papers on the topic at the conference, spoke at the media conference about the facts on antimicrobial resistance in animals and the potential impact on people. although the situation in australia is better than in many other parts of the world, the take home message was that we can't be complacent. australia needs a long-term national surveillance program of antibiotic resistance before any problems get out of hand. you can view some of the coverage at yahoo news (aap) and abc rural. this year's asava conference resulted in a tv news piece on nbn and an interview with david neck on abc brisbane. several media releases to support the world buiatrics congress delivered media impressions in queensland country life, abc rural, the veterinarian and southern cross radio among others. every year the ava conducts media training sessions using professional media trainers to ensure we have a pool of spokespeople to cover every division, sig and potential topic of media interest. we have been very fortunate with the calibre of ava volunteer spokespeople over the years and they have been instrumental in helping us to achieve such excellent exposure for the profession and the ava in the media. comment on this article at www.ava.com.au/ protection against hendra at equestrian events e quine veterinarians australia (eva) has recently advised members on the best-practice approach to managing hendra risk at equestrian events. "managing hendra biosecurity risk at events is extremely challenging due to the nature of the disease and the large number of horses and people intensively interacting, " said nathan anthony, president of eva. "event organisers have a responsibility to ensure a safe environment for horses and people. however, not all event organisers are willing or able to implement and adhere to hendra biosecurity essentials during an equestrian event, " dr anthony said. veterinarians providing services at equestrian events have obligations in relation to work health and safety, and they are expected to provide accurate advice on biosecurity threats. eva has provided recommendations and resources to help veterinarians meet these obligations. "for events in queensland and new south wales, eva advises organisers to implement a mandatory hendra vaccination requirement for all event participants. this is to protect both people and horses from the extremely serious effects of an outbreak at an event, " dr anthony said. "for events in other states and territories, we advise event organisers to require horses travelling from queensland or new south wales to be vaccinated against hendra virus. "eva has developed resources to help vets communicate this advice and to ensure that event organisers acknowledge their responsibility to manage the risk of a hendra outbreak, " he said. a ntimicrobial resistance threatens human and animal health worldwide. antibiotic awareness week australia ( - november) forms part of a global campaign to increase awareness of antimicrobial resistance and to promote responsible use of antimicrobials. the veterinary profession is involved this year through the ava's strategic priority program 'fighting antimicrobial resistance' . the veterinary profession has adopted the one health concept of expanding interdisciplinary collaboration and communications in all aspects of health care for humans and animals. veterinarians are seen by other health professions and the public as key players in the responsible use of antimicrobials, because of our stewardship over a considerable amount of antimicrobial use in companion and food animal species. participating in antibiotic awareness week alongside human health professionals is a key way for veterinarians to demonstrate their commitment to working with others to help solve this global crisis. the focus on antimicrobial resistance and use in humans and animals is increasing around the world, and both the world health organization and world organisation for animal health (oie) are leading policy to extend the useful life of antimicrobials. here in australia, the departments of agriculture and health are developing a national strategy on antimicrobial resistance similar to canada, the united states and the united kingdom. resistance to antibiotics is found in australian hospitals and increasingly in the community. multidrug-resistant bacterial pathogens are becoming more prevalent. patients with resistant infections experience delayed recovery and treatment failure and are more likely to die than patients with non-resistant infections. the profession and the ava have been proactive in addressing antimicrobial resistance concerns, naming 'fighting antimicrobial resistance' as one of the ava's five strategic priorities. recent new resources have included simple one-page guidelines on the principles of responsible prescribing of antimicrobials by veterinarians and a client fact sheet on safe handling of animals being treated with antibiotics. the ava is also currently exploring options to develop new national guidelines to help veterinarians ensure they're making the best decisions when prescribing antibiotics. the australian veterinary journal has recently published several articles on antimicrobial resistance and its effect on our patients and ourselves, including articles on methicillin-resistant staphylococcus aureus (mrsa) in horses, vet hospitals and its carriage by veterinarians. australia is in an enviable position with regard to antimicrobial resistance -we have never allowed the use of fluoroquinolones in food-producing animals, and a recent survey by meat and livestock australia showed low levels of resistance in australian beef. over time, the one health focus on antimicrobial resistance will increase and it's important that veterinarians are proactively involved and informed of their responsibilities when using antimicrobials in all areas of practice, both companion and food animals. in the future, veterinarians may well be more involved in human cases of antimicrobial resistance. for example, family pets may be identified as reservoirs of infection. veterinarians may have to make decisions on whether to use the newest 'big gun' antimicrobial or more conservative treatment. off-label prescribing and compounding practices in food-producing animals may also come under increasing scrutiny. these challenges will provide an opportunity to underscore the importance of veterinary science to the overall health of both humans and animals. veterinarians are not unique in facing this challenge. more than health professionals have already taken a pledge to support the mind me principles: microbiology guides therapy wherever possible indications should be evidence based narrowest spectrum required dosage appropriate to the site and type of infection minimise duration of therapy ensure monotherapy in most cases. indeed, clients may come to expect this approach from all health professions, veterinarians included. jonathan taylor amrric is an independent group of veterinarians, academics and health professionals, both indigenous and non-indigenous, working in the one health framework to improve the health and well-being of companion animals and their communities. since its inception, amrric has focused on developing and implementing sustainable, culturally-sensitive programs in rural and remote aboriginal and torres strait islander communities. this program has seen dozens of veterinarians, nurses and other volunteers from around australia and overseas donate their time and skills in desexing, worming and treating animals in some of the country's most remote communities. the conference, held in darwin in conjunction with the international fund for animal welfare (ifaw), attracted over delegates from australia and around the world. following a welcome to country by larrakia elder bilawara lee, amrric president ted donelan and ifaw regional director, isabel mccrea, opened proceedings. keynote speakers included kate nattrass atema, ifaw's program director companion animals, who discussed the logistics of animal welfare programs in countries ranging from bosnia to bali. dr frank ascione, from the university of denver, has performed extensive research on the link between animal abuse and interpersonal violence. he discussed the relationship between mental health and animal abuse, as well as animal abuse as an indicator of family violence. he also discussed initiatives that had been developed as a result of this research, including pet-friendly shelters for victims of domestic violence. with the threat of a rabies incursion into northern australia presenting a real risk to remote communities, the topic of rabies detection and control was a key theme of the conference. a panel of experts, including nt chief veterinary officer dr malcolm anderson, nt centre for disease control public health physician dr charles douglas, northern australia quarantine strategy veterinary officer joe schmidt and former nsw chief veterinary officer helen scott-orr, participated in a simulated rabies incursion to assess australia's preparedness for such an outbreak. issues raised included the number of vaccinated veterinarians available to assist in such an event, the need for existing relationships with and experience with communities, and understanding of dog population dynamics in remote communities. above all, the conference provided an opportunity for those working at the coalface to connect with others in academia and government and ensure that community animal health and welfare are on the agenda. "what i have learnt there was very motivating and made me see my community from another perspective, " said torres strait island regional council animal management worker, william bero. "it has motivated me to continue in promoting healthy and happy animals equals healthy and safe community. " the study reaffirms much of what we already know, but it is an australian study -which is important, as we don't have much local data, " said dr andrew carter, ava sa division president. "interestingly, the study also noted that two-thirds of incidents involved the dog being provoked. this is significant, as it again points to the need for children to be taught about appropriate interaction with pets, but also highlights the need for adults to step in, " dr carter said. in regard to breed, the study finds that breed-specific legislation is not necessarily effective and proposes the development of a set of well-defined criteria that enables early identification of dangerous dogs on an individual basis. "this is very much in line with our own ava research, which emphasises the importance of education coupled with identification and control of individual 'potentially dangerous' dogs along with 'dangerous' dogs, " dr carter said. the results mirror another recent study of dog bite-related fatalities in the united states. that study, released late last year, looked at fatalities from to . although calculated risk factors could not be specified by the study, the key factors that were found to be present in fatal attacks were: • absence of someone to intervene • the dog and victim were unknown to each other • the dog was not desexed • compromised ability of victims to interact appropriately with dogs • the dogs were isolated from regular positive human interactions (possibly kept outside) • owners' prior mismanagement of dogs • owners' history of abuse or neglect of dogs. importantly, in the majority of fatalities at least four of these factors were in place. the study reinforced other findings relating to breed, stating that dog bite-related fatalities "were characterized by coincident, preventable factors; breed was not one of these. " the paper also notes that although desexing appeared to be a factor, it is uncertain whether this is causal or coincidental. they note that past research "…suggests that owner failure to have their dog spayed or castrated may co-occur with other factors that more directly influence a dog's social competence. " executive officer -sa and nt division comment on this article at www.ava.com.au/ the results support the existing understanding of dog bite incidents: dog bites are most likely to involve children aged - years, who are bitten on the face by a familiar dog and in a familiar environment. esutures is a discount distributor of ethicon, covidien, synthes, bard and arthrex suture, mesh and surgical devices. we specialize in selling brand name products at below market prices in quantities you decide. we stock thousands of surgical devices available by the box or by the individual item, and ready to ship today! no contracts. no minimum orders. fast shipping. all orders ship global priority from the u.s. at a flat rate. order today: info@esutures.com www.esutures.com use promo code: avj for $ off your next order of $ or more.* a ccording to the food and agriculture organisation of the united nations (fao), a recent strain of avian influenza virus in poultry in southeast asia needs to be closely monitored. known as a(h n ), the fao says it represents a new threat to animal health, with recent detection in poultry in the lao pdr and vietnam after first being reported in poultry in china in april . it also represents a threat to the poultry-related livelihoods that contribute to the incomes of hundreds of millions of people in the region. fao's chief veterinary officer, dr juan lubroth, said that influenza viruses are constantly mixing and recombining to form new threats. "h n is particularly worrisome as it's been detected in several places so far from one another. and because it's so highly pathogenic, meaning infected poultry become sick and, within hours, death rates are very high, " dr lubroth said. the world health organisation for animal health (oie), which works together with the fao and the world health organization (who) to support countries' responses to animal and human disease threats, is also monitoring the situation closely. only one case of h n has been reported in humans after contact with exposure to poultry shortly after its detection in china. the person later died. according to the who, although the dynamics of the new strain are still not fully understood, it's unlikely that h n represents an immediate and significant threat to human health. both the who and fao have advised that even if the public health risks posed by h n currently appears to be low, it is still of concern and they recommend that consumers follow appropriate hygiene, food preparation and food safety guidelines. these include washing hands often, cleaning utensils and surfaces used during food preparation and eating only well-cooked poultry meat products. people should also avoid handling sick birds or those that have died of illness. the fao is also urging countries to remain vigilant to prevent further spread of the virus and is recommending that governments in the area support poultry producers in following essential biosecurity measures and standard hygiene precautions. this includes early detection, immediate reporting and rapid response. comment on this article at www.ava.com.au/ d r russell dickens oam is a trailblazer and mentor to countless young and now a bit older veterinarians. dr robert johnson suggested we shine the avj member spotlight on his mentor, dr dickens, so we can share his story with ava members. dr dickens started a veterinary practice in western sydney in and has been protecting australian wildlife and caring for animals, farmers and pet owners ever since. he has seen western sydney transition from a rural, farming community to a burgeoning, densely-populated metropolis and has evolved his practice to meet the changing needs of his community. beyond his practice and research work, dr dickens is a primary producer of angus beef at cullen bullen and has also placed his considerable energy into community activities. he has been a councillor at blacktown council for over years, served as mayor and is currently deputy mayor, while still working at his practice. he is a foundation member of the animal ethics committee at westmead hospital and millennium institute, a rotary paul harris fellow, on the salvation army's advisory board and this year was lauded with the university of sydney's alumni award, which places him among some of the sharpest minds in australia. dr johnson recounted a recent saturday afternoon, when he thought he'd done a stellar day's work after a full week. he finished by pm and thought he'd pop in to visit dr dickens' practice. "i found a packed waiting room with russ methodically managing the clients by himself. when he saw the look on my face, he smiled and said, 'i'm also acting mayor today' , " dr johnson recalled. he also still -almost exclusively -runs his practice's out-of-hours service and has done so since the s. "age is a matter of mind. if you don't mind it doesn't matter, " he quipped. when asked to recall a time he had shared with his mentor that had a particular effect on him, robert chose to share the aftermath of being sent to help a friesian cow with a dislocated hip, some years ago. "russ sent me out to attend to a large heifer and i managed to sedate her, get her to lie down and with the farmer's help and some impressive force, to reduce the dislocation. triumphant, i headed back to the practice where russ looked at me with some surprise. i asked, "why the funny look?" russ said that he had expected me to be covered from head to toe in mud and to provide him with his entertainment for the afternoon. like most other days, we laughed. "russ has taught me the two most important things in my career: that it's fun to be a veterinarian and you should always be prepared to laugh at yourself, " dr johnson said. e ach year the ava recognises those who contribute to and serve the veterinary profession or the association. nominations are now open for the following prizes and awards: this is the ava's most prestigious award for outstanding service by a member or a non-member to veterinary science in australia. nominees who were unsuccessful from the previous two years are automatically included. issued jointly with the australian college of veterinary scientists, the kesteven medal is awarded to members for distinguished contributions to international veterinary science through technical and scientific assistance to developing countries. nominees who were unsuccessful from the previous two years are automatically included. awarded to members for outstanding service to the association. the award is given either to members who have rendered meritorious service to the association, regional divisions, branches or special interest groups, or to persons who are not eligible for membership of the association but have clearly provided meritorious service to those bodies. awarded to eminent non-veterinarians for services to the ava or the veterinary profession. animal health australia, the australian veterinary association and guild insurance have put together a unique framework to cover private practising vets like you to assist in an emergency animal disease response. no other insurer offers this unique cover. for leading veterinary business insurance and professional indemnity insurance call us today for a quote. insurance issued by guild insurance ltd (gil) abn , afsl and subject to terms, conditions and exclusions. gil supports your association through the payment of referral fees. gil will assess an eadr outbreak and make a decision to provide cover on a case by case basis. gil will need to be contacted for the cover to be activated. additional premiums may apply depending on existing cover with gil. for information on the guild veterinary business insurance policy, refer to the product disclosure statement (pds) and policy wording. you can get a copy of the pds by calling . gld avj eadr ad / while you're taking care of an emergency, who's taking care of you? make the right choice. freecall guildinsurance.com.au/eadr d r alex rosenwax from waterloo in sydney, reports that he has had five unrelated unusual cases of rabbit deaths over the past few weeks. all presented with gastrointestinal stasis and were febrile with anorexia. the signs appeared to be consistent with calicivirus and all died within - hours, despite intensive treatment. all came from one general area of sydney, and they had been vaccinated in the past. "i have contacted the dpi and they have confirmed that a new strain of calicivirus has been documented in sydney by elizabeth macarthur agricultural institute (emai) in the past year. that strain is resistant to the vaccine. their signs were similar to the ones in the rabbits we have seen, " said dr rosenwax. rabbit haemorrhagic disease virus (rhdv) is a calicivirus that usually kills % of susceptible adult rabbits within hours, but the molecular mechanisms for this virulence are unknown. it has been used in australia as a biological control agent to reduce rabbit numbers since it was released in . there is also an endemic non-pathogenic australian rabbit calicivirus, rcv-a , that is known to provide some cross-protection to lethal infection with rhdv, and pet rabbits are usually vaccinated against the endemic strain to protect them. australia's chief veterinary officer, dr mark schipp, notified oie of the new strain in january this year. the notification related to the outbreak in sydney where sudden deaths occurred in show rabbits of various ages and both sexes. there were very few clinical signs prior to death. the rabbits had previously been in good health and were vaccinated against the endemic strain of rabbit calicivirus. of the susceptible rabbits, there were cases, and deaths, equating to an apparent morbidity rate of . %, mortality rate of . %, and case fatality rate of . %. gross necropsy findings showed little signs of the heavy haemorrhage usually seen with rhdv. they had more cranial changes. emai reported that the normal elisa test for calicivirus was negative whereas pcr was positive. some of the rabbits were presented to dr rosenwax because they were apparently having seizures. he noted that although his cases were highly suspicious of calicivirus, as the appropriate samples had not been taken, the cases could not be confirmed. a nonformalin-fixed, frozen -g liver sample is required for submission to emai to confirm the presence of the virus. tracing and surveillance of the new strain is underway to determine how many rabbits have been exposed and how widespread the virus is. this may have implications for pet rabbits, as evidence suggests the current vaccine may not be effective against this new strain. this new strain also has implications for rabbit control. the invasive animal cooperative research centre (ia crc) research shows that australian native vegetation is very sensitive to rabbit damage, and as few as . rabbits per hectare can remove all seedlings of the more palatable native trees and shrubs, so delaying natural regeneration. rabbits are australian agriculture's most costly pest animal with the annual cost of over $ million. according to the ia crc, the use of myxomatosis and calicivirus is still limiting rabbit numbers and without them, the annual cost to agriculture from the imported pest would exceed $ billion. however, they report that rabbit numbers are increasing, with research also showing there are a number of rabbit colonies that are immune to the calicivirus. without this virus, other control techniques would need to be tried, including warren ripping, fumigating, shooting and baiting. the ia crc is now involved in studies to evaluate other rhdv strains, mainly because there is increasing genetic resistance in the rabbits to current rhdv strains and young rabbits are acquiring immunity. dr rosenwax reports that in the absence of a definitive diagnosis, his practice has instituted quarantine for all rabbits with suspicious clinical signs. we heard about the contrasting aspects of rural practice in three different areas of australia. all seemed to share similar problems of beef and dairy profitability, increased numbers of graduating veterinarians, competition from paraprofessionals, the cost of travel and the loss of populations from rural towns. david petersen from deniliquin, told us about his practice in the dairy area of the riverina in victoria. there is no water except for irrigation -the gates on the channels are opened at the top levels, and the water 'wooshes' down for about hours per day. they see american holstein cattle, which are big cows with lots of milk, that have poor reproductive function, in an area where daytime temperatures are regularly between and ºc, and ºc at am. the veterinarians keep temperature logs in their cars, and have to throw away medications if they get too hot. sam mcmahon told us of her experiences in setting up the northern territory veterinary services in katherine. with an area of . million km , slightly bigger than nz, uk, ireland and france combined, but with a population of only , , they need a fleet of wd to cover the area. their practice includes going out to stations and indigenous communities and their new branch in alice springs is a . hour road trip away from their main centre. brahman cattle are most common in the humid katherine, and british cattle breeds in the drier alice springs area. comment on this article at www.ava.com.au/ workshop host bill tranter's practice covers km to the north, south and west, with two small animal and equine practices in mareeba. they cover extensive beef in the west of the region as well as herd health management for the more intensive dairy industry. the practice is an integral part of clinical training at james cook university. our first visit was to a relatively small feedlot, with heat-tolerant brahman-cross cattle. the property has . metres of rain annually, and also produces silage. the next stop was at a dairy of between and holstein cows. the tropical grasses grow very slowly except for a flush when it rains in december. they have a year-round calving pattern, and have to produce the same amount of milk throughout the year. their best conception rates are in the cooler winter months, and they also produce silage and grow ryegrass to boost production at that time. bull and heifer reproductive examination was next, with andrew hoare demonstrating the ultrasound probe and showing us ovarian anatomy, and enoch bergman demonstrating the intimacies of bull examination. andrew hoare multitasking i wasn't the only one taking photos communicationthe essential ingredient w ith the increasing amount of technology changing the way we communicate, it can be difficult to find the best medium to engage with all of your stakeholders. despite all these advancements, in particular the role of the internet, text messaging and social media in our lives, there is still no replacement for verbal communication in a work environment. it is verbal communication that is the essential ingredient in building an efficient and harmonious workplace. the key to an efficient workplace is to create an environment that is conducive to open and honest communication. this creates a positive relationship between employee and employer and while this relationship remains positive, then the workplace will usually stay productive. most issues with employees can be resolved through a face-to-face discussion where both parties are able to voice concerns, resolve misunderstandings and get a clear understanding of each party's motivations and the solutions required to overcome any grievances. communication is a two-way process. it involves both the dissemination of information, but even more importantly, the receipt of information through genuine listening. both are equally important for the employee and the employer. firstly, managers need to explain to employees what is expected of them and not simply rely on job descriptions to explain this. employees also have an obligation to ask questions if they are unsure about work requirements and advise managers of any changes that may affect the way they perform the job, or improve the process to deliver expected outcomes. it has often been said that the employment relationship is similar to a marriage. both parties enter into the relationship with the best of intentions, but throughout the relationship there will be good and bad times, which put the relationship to the test. once communication becomes difficult, or either party looks for ways to avoid verbal communication, it is a strong sign that there is a problem. the only way to resolve these problems is to address them as soon as the issue is identified and do this face-to-face. just because an employee chooses to communicate via text, it is never a good idea for a manager to start texting anything more than confirming receipt of the message. it is always best to make a phone call and talk to the employee directly. there can never be too much communication. managers do not have to wait for that annual review, or monthly meeting, to raise a concern or discuss a matter with their employees on any matter. frequent communication on any matter will assist in building relationships. communication must be kept simple and relevant with employees -don't start communicating information that does not affect the employee. importantly, effective communication does not mean gossiping about an employee's personal life; it simply means communicating what is expected of employees and issues that might be affecting their performance and the effect on other stakeholders. in summary, there are three things that are critical to build an efficient workplace ... communication, communication, communication. if you do this well, you will reduce and avoid most workplace relations issues. michelle eamer ava hr advisory service comment on this article at www.ava.com.au/ the material contained in this article is general comment and is not intended as advice on any particular matter. no reader should act or fail to act on the basis of any material contained herein. the material contained in this publication should not be relied on as a substitute for legal or professional advice on any particular matter. suicidal behaviour and psychosocial problems in veterinary surgeons: a systematic review veterinary surgeons and suicide: a structured review of possible influences on increased risk the role of veterinary team effectiveness in job satisfaction and burnout in companion animal veterinary clinics references . nobanis. invasive alien species fact sheet: -aphanomyces astaci. www.nobanis.org the effects of crayfish plague on finland's crayfish economy australian fisheries statistics manual of diagnostic tests for aquatic animals cultured aquatic species information programme: procambarus clarkii (girard, ) the crayfish plague pathogen can infect freshwater-inhabiting crabs defence reactions in and susceptibility of australian and new guinean freshwater crayfish to european-crayfish-plague fungus event summary: crayfish plague (aphanomyces astaci) australian government department of agriculture, fisheries and forestry. identification field guide to aquatic animal diseases of significance to australia. th edn. www.daff.gov.au/animal-plant-health/pests-diseases-weeds/ 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australia antimicrobials and the cattle industry methicillin-resistant staphylococcus aureus in a family and its pet cat nps medicinewise: resistance fighter pledge first-time study of women's and children's hospital bite victims shows that nine in attacks is by a familiar dog retrospective review of dog bite injuries in children presenting to a south australian tertiary children's hospital emergency department policy and model legislative framework co-occurrence of potentially preventable factors in dog bite-related fatalities in the united states rabbit haemorrhagic disease invasive animals cooperative research centre. landscape control -rabbits prices include delivery of print journals to the recipient's address. delivery terms are delivered at place (dap); the recipient is responsible for paying any import duty or taxes. title to all issues transfers fob our shipping point, freight prepaid. we will endeavour to fulfil claims for missing or damaged copies within six months of 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association limited. key: cord- -ju bq authors: last, john title: a brief history of advances toward health date: journal: understanding the global dimensions of health doi: . / - - - _ sha: doc_id: cord_uid: ju bq three major discoveries determined the health and history of the human species. the first occurred almost a million years ago, when our hominid precursors discovered how to use fire to cook the meat they had hunted. they found that cooked meat tasted better, it didn’t go bad so quickly, and eating it was less likely to make them ill. our understanding of nutrition, a basic tenet of public health science, and the art of cooking have been improving ever since. as humans grew fruitful and multiplied, so did the variety and number of their diseases. permanent human settlements transformed ecosystems, and abiding by epidemic theory, the probability of respiratory and fecal-oral transmission of infection rose as population density increased. ecological and evolutionary changes in micro-organisms account for the origins of diarrhea , measles, malaria, smallpox, plague, and many other diseases. micro-organisms evolve rapidly because of their brief generation time and prolific reproduction rates. many that previously had lived in symbiosis with animals began to invade humans, where they became pathogenic. some evolved complex life cycles involving several host species, such as humans and other mammals, humans and arthropods, and humans and freshwater snails. these evolutionary changes in host-parasite relationships occurred at least several millennia before we had created written histories. our oldest written records that have a bearing on health date back about , years. the code of hammurabi (c. bce) contains ideas indicative of insight into the effects on health of diet and behaviour. it also suggests rewards and punishments for physicians who did their jobs well or poorly. information about the impact of diseases, especially of epidemic diseases, from those ancient times has come down to us in myths and biblical accounts of pestilences and plagues, although we cannot reliably identify the nature of the epidemics that afflicted ancient populations. the greek historian thucydides provided a meticulously careful description of an epidemic that struck the athenians in the second year of the peloponnesian war in bce, from which the forces of athens perhaps never fully recovered. modern infectious disease specialists have puzzled over this epidemic. was it typhus, a virulent form of epidemic streptococcal infection, that is, a variant form of scarlet fever, or something completely different? similar questions have been raised about other ancient epidemics, for instance the sweating sickness that recurred many times in mediaeval europe then vanished, never to be seen again, almost , years ago. there has been debate too about the exact nature of the black death, the terrible pandemic that devastated asia minor and the whole of europe in - . this is usually attributed to the plague bacillus, yersinia pestis, but revisionist historians and epidemiologists have raised the possibility that other pathogens, for instance, the anthrax bacillus, might have been responsible. here, as with the plague of the athenians, the plague of justinian, the medieval sweating sickness, the accounts of apparent fulminating epidemic syphilis (that may really have been another sexually transmitted disease or may have been caused by a highly virulent variant of the causative organism of syphilis, treponema pallidum, which has slowly lost its extreme virulence and infectivity), and, indeed, as with all other great epidemics of historical times before the rise of modern microbiology, we can only speculate about the exact aetiology and pathogenesis. this is a rather sterile, albeit fascinating, quest. it is more productive and useful to focus on what we know with reasonable certainty, and it is simplest to describe this knowledge in relation to some of the heroic figures who have contributed to advances in our understanding of epidemics and other diseases that have helped to shape history. this account therefore concentrates on a handful of the heroes of public health through the course of written history. hippocrates , the father of medicine, was also the father of public health. he practised and taught in a school of medicine at the temple of asklepios, near epidaurus in greece, and alone or with members of his school, laid the foundations of rational clinical medicine with careful descriptions of diseases and common sense ideas about ways to manage them. the hippocratic writings contain rich medical wisdom based on careful observation of sick and healthy people and their habits and habitats. epidemics is a series of case records of incidents of diseases, many of which we now know to be caused by infectious agents. the accounts of tetanus, rabies, and mumps, for instance, could have been written by a modern clinician. airs, waters, places outlines environmental health as it was understood two-and-a-half thousand years ago. the relationships of environment, social conditions, and behaviours to health and sickness is made explicit in the timeless advice of the opening paragraph: whoever would study medicine must learn of the following. first, consider the effect of each of the seasons . . . and the differences between them. . . . study the warm and cold winds . . . and the effect of water on health . . . when a physician comes to a district previously unknown to him he should consider its situation and its aspect to the winds . . . and the nature of its water supply . . . whether the land be bare and waterless or thickly covered with vegetation and well-watered, whether in a hollow and stifling, or exposed and cold. lastly, consider the life of the inhabitants-are they heavy drinkers and eaters and consequently unable to stand fatigue, or being fond of work and exercise, eat wisely but drink sparely. in short, study environment and life style, which are very modern concepts. for well over a thousand years after hippocrates' lifetime, human communities were afflicted with ever-present respiratory and gastrointestinal infections that cut deeply into the lives of everyone, and most deeply, as a rule, into the lives of young children who all too often died before they reached adolescence, carried off by measles, scarlet fever, diphtheria, bronchitis, croup, pneumonia, gastroenteritis, or typhoid. from time to time, this steady drain on long life and good health was punctuated by great and terrifying epidemics-smallpox, typhus, influenza, and, most terrible of all, the plague, or the "black death." the causes of these periodic devastations, the contributing reasons to why they happened, were a mystery. many at the time believed they were god' s punishment for sin, or the work of evil spirits. ideas about contagion were rudimentary, even though it had been dimly understood since antiquity that leprosy, perhaps the least contagious of all the infectious diseases, was associated with propinquity and uncleanliness. the th century italian monk, fracastorius, recognized some ways infection can spread. his conclusion, that disease could pass by intimate direct contact from one person to others, was easy to draw because he saw the dramatic epidemic of syphilis that was so obviously spread by sexual intercourse. he described this in a mock heroic poem, syphilis, sive morbis gallicus ( ) about the swineherd syphilis, and how he got and passed on to others the "french disease" then raging in europe. his anti-hero, of course, gave us the name of the disease. fracastorius' s other concepts, contamination by droplet spread and by way of shared contaminated articles, such as clothing and kitchen utensils, were published in de contagione in . fracastorius is important because he made a conceptual breakthrough-he brought about what thomas kuhn calls a paradigm shift in understanding of infection and some ways to control it. after fracastorius, the pathfinders on the road to health became numerous, but mention here will be made of only a handful of public health heroes: paracelsus, john graunt, antoni van leeuwenhoek, bernardino ramazzini, james lind, edward jenner, johann peter frank, john snow, ignaz semmelweiss, and louis pasteur. the swiss alchemist theophrastus bombastus von hohenheim, known as paracelsus ( - ), occupies the junction of medieval alchemy with scientific chemistry, pharmacy, medicine, and environmental health. he was a colourful character, a foul-mouthed drunkard who insulted and sometimes fought those who disagreed with him, whom he considered superstitious nincompoops. he recognized the relationship of goitre to cretinism, the fact that inhaled dusts caused lung disease, and that some common mental disorders were diseases, not caused by witchcraft or 'possession' by evil spirits. he experimented with chemical remedies containing compounds of mercury, lead, and other galenicals, observed their effects, and, thus, could be considered also a founding figure of pharmacology. john graunt ( graunt ( - , a london merchant haberdasher, was an amateur scientist and an early fellow of the royal society. he was interested in the impact of epidemics, especially the plague, and how plague outbreaks caused the numbers of deaths, and the age at death, to vary from one year to another. for over years before his time, parishes had kept records of baptisms and deaths, and what was then understood about causes of death was inscribed in the bills of mortality. graunt collected and analyzed these bills of mortality. he demonstrated statistical differences between males and females, between london and rural areas, and the ebb and flow of epidemics of plague. he published his work in natural and political observations ... upon the bills of mortality (london, ). this work was the foundation for the science of vital statistics. john graunt demonstrated the importance of gathering facts in a systematic manner, to identify, characterize and classify health conditions of public health importance. the diagnostic categories in the bills of mortality tell us what was understood years ago about the variety of human ailments and their causes. the nature of diseases caused by things not visible to the naked eye was long a mystery that began to unravel when antoni van leeuwenhoek ( - ), a dutch linen draper and amateur lens-grinder in delft, perfected the first functioning microscopes, with which he viewed drops of water, vaginal secretions, feces, his own semen, and the detailed structures of plants and insects. he lacked any formal scholarly training but in a series of letters to the royal society of london, he described accurately and in detail all that he saw. he did not suggest that the tiny creatures he was the first to see with his microscope were capable of causing diseases, but he is nonetheless regarded as the first of the 'microbe hunters' who sought and identified the pathogenic micro-organisms responsible for many diseases. bernardino ramazzini ( - ) was an italian physician who observed and classified workers in many occupations, and reported his observations and conclusions about the diseases to which workers in each of these were vulnerable in de morbis artificum diatribe (on the diseases of workers, ). it is a tour de force, a masterly account in the form of sweeping generalizations, and although the evidence supporting these generalizations was often flimsy, ramazzini introduced a new way of thinking about ways in which work conditions can affect health. james lind ( lind ( - was born and educated in edinburgh. he was apprenticed to a surgeon when he was , and spent nine years as a naval surgeon, during which time he saw many cases of scurvy, a disease that disabled and often killed sailors on long ocean voyages. lind thought this disease might be caused by a diet lacking fresh fruit and vegetables. he conducted an experiment, giving different diets to each of several pairs of sailors. this was the first clinical trial ever conducted-although the sample sizes were very small, there was no random allocation, and no informed consent was obtained from the sailors. the two sailors who received fresh oranges and lemons recovered rapidly from the scurvy, the others did not, or got worse. lind also initiated the first effective measures aimed at enhancing hygiene in the british navy, but he is best known for his work on scurvy, reported in a treatise of the scurvy ( ). not only was this the first reported clinical trial, it also was proof that a dietary deficiency can cause disease, that a well-balanced diet is essential for good health. thus lind, like fracastorius, was responsible for an important paradigm shift in the understanding of causes and control of disease. johann peter frank ( - ) studied medicine in heidelberg and strasburg, was a professor of medicine at göttingen and pavia, and taught in many other centres of learning including st petersburg, before he ended his career in vienna where he was professor of medicine at the allegemeines krankenhaus. early in his career he began writing system einer vollständigen medicinischen polizey, his great work on ways to improve population health. this appeared in a series of nine volumes from to . it was, as the title indicates, a system dealing with every then-known way to protect and preserve good health, including community hygiene, personal health protection by cleanliness, and a suggested set of laws and regulations to govern the control of conditions in lodging houses and inns, medical inspection of prostitutes, and so on. edward jenner ( jenner ( - was an english family doctor who practised throughout his life in the village of berkeley, gloucestershire. in his days, smallpox was a ubiquitous threat to life and health. in severe epidemics, it killed up to a quarter of all it attacked. when it did not kill, it often left disfiguring facial pockmarks and if it infected the eyes it caused blindness. the practice of variolation, inoculation into the skin of dried secretions from a smallpox bleb, was invented in china about years ago and spread along the silk route, reaching asia minor in the th century. lady mary wortley montague, wife of the british ambassador to constantinople, described the practice in a letter dated april , , and imported the idea to england when she came home. by the time jenner was a child, variolation had become popular among educated english families as a way to provide some protection against smallpox. jenner knew the popular belief in gloucestershire that people who had been infected with cowpox, a mild disease acquired from cattle, did not get smallpox. he reasoned that since smallpox in mild form was transmitted by variolation, it might be possible similarly to transmit cowpox. a smallpox outbreak in gave him an opportunity to confirm this notion. in he began a courageous and unprecedented experiment-one that would now be unethical, but that has had incalculable benefit for humankind. he inoculated a boy, james phipps, with secretions from a cowpox lesion. in succeeding months, until the summer of , he inoculated others, most of them children, to a total of . all survived unharmed, and none got smallpox. jenner published an inquiry into the causes and effects of the variolae vaccinae in -perhaps the most influential public health treatise of all time. the importance of jenner' s work was immediately recognized and although there were sceptics and hostile opponents, vaccination programs began at once. the frequency and ferocity of smallpox epidemics began to decline early in the th century, but the disease remained a menace until the mid- th century. in , the american epidemiologist donald soper worked out the strategy of containment, in other words, vaccinating all known contacts of every diagnosed case. in , who embarked on a global campaign to eradicate smallpox. the last naturally occurring case was a girl in somalia in . in , the world health assembly proclaimed that smallpox, one of the most deadly scourges of mankind, had been eradicated. at the beginning of the new millennium, samples of smallpox virus are preserved in secure biological laboratories in several countries, but, thanks to edward jenner, this terrible disease need never again take a human life-unless it is used illegally in biological warfare. john snow ( - ) was a london physician, and a founding father of modern epidemiology. (he was also a pioneer anesthetist who invented a new kind of mask to administer chloroform, which he gave to queen victoria to assist at the births of her two youngest children.) snow' s work on cholera demonstrated fundamental intellectual steps that must be part of every epidemiological investigation. he began with a logical analysis of the available facts, which proved that cholera could not be caused by a 'miasma' (emanations from rotting organic matter) as proposed in a theory popular at that time, but must be caused by a transmissible agent, most probably in drinking water. he confirmed the proof with two epidemiological investigations into the great cholera epidemic of . he studied a severe localized epidemic in soho, using analysis of descriptive epidemiological data and spot maps to demonstrate that the cause was polluted water from a pump in broad street. his investigation of a more widespread epidemic in south london involved an inquiry into the source of drinking water used in over households. he compared the water source in houses where cholera had occurred with that in others where it had not. his analysis of the information about cases and their sources of drinking water showed beyond doubt that the cause of the cholera outbreak was water that was being supplied to houses by the southwark and vauxhall water company, which drew its water from the thames downriver, where many effluent discharges polluted the water. very few cases occurred in households supplied with water by the lambeth company, which collected water upstream from london, where there was little or no pollution. john snow reasoned correctly that the cholera must be caused by some sort of agent in the contaminated water supply. this was a remarkable feat, completed years before robert koch identified the cholera bacillus. snow published his work in a monograph, on the mode of communication of cholera ( ). this book has been reprinted in modern editions and is still used as a teaching text. the hungarian physician ignaz semmelweiss ( - ) was a great but tragic figure. working in the obstetric wards of the allgemeines krankenhaus in vienna, he tried to transform traditional but ineffective treatment methods by using logic and statistical analysis to demonstrate the efficacy, or lack of it, when he compared treatment regimens. he believed in the germ theory of disease and was convinced that the terrible death rates from puerperal sepsis must be caused by germs introduced into the raw uterine tissues by birth attendants who did not disinfect their hands. he carried out a meticulous comparative mortality study in his own wards, where he insisted that all birth attendants must cleanse their hands in a disinfectant solution of bleach, and other wards run by senior obstetricians where hand-washing was not routine. his senior colleagues regarded his findings as a gross insult to their professional competence. semmelweiss' s rather abrasive nature and his jewish origins in the anti-semitic atmosphere of th century vienna made matters worse for him. he was hounded out of his hospital post, and ended his life in a mental hospital. his belatedly published comparative statistical analyses of the death rates from puerperal sepsis in his own and other wards of the allgemeines krankenhaus are a model of how to conduct such studies, but, unfortunately, no one in vienna heeded him and young women continued to die of childbed fever for another generation. medical science advanced rapidly in the second half of the th century, applying the exciting discoveries of a new science, bacteriology, which transformed public health. the great bacteriologists of the late th century identified many pathogenic bacteria, classified them, developed ways to cultivate them, and, most important, worked out ways to control their harmful effects, using sera, vaccines, and "magic bullets" such as the arsenical preparations that ehrlich developed to treat syphilis. it would be useful to discuss each of them, but i will focus on just one, louis pasteur ( - ). this french chemist evolved into a bacteriologist, and was a towering figure of th century bacteriology and preventive medicine. in , he had recently been appointed professor of chemistry in lille, and was invited to solve the problem of aberrant fermentation of beer that caused it to taste bad and made it undrinkable. he showed that the problem was caused by bacteria that were killed by heat. in this way he invented the process for heat treatment to kill harmful bacteria, first applied to fermentation of beer, then to milk-the process known ever since as pasteurization that has saved innumerable children from an untimely death. he went on to study and solve many other bacteriological problems in industry and animal husbandry. he developed attenuated vaccines, first to prevent chicken cholera, then, in , to control anthrax, which was a serious threat to livestock and, as well, occasionally to humans. before this, in , he began experiments on rabies, seeking a vaccine to control this disease, which without treatment is invariably fatal. as a result of the success of the anthrax vaccine, he believed that an attenuated rabies vaccine could be made. this, of course, was many decades before the virus was visualized. he prepared and successfully tested his rabies vaccine in on a boy, joseph meister, who had been bitten by a rabid dog. pasteur became not just a national but an international celebrity. born in the same year as louis pasteur, the austro-hungarian monk gregor mendel ( - ) was another amateur scientist, a botanist. experimenting with varieties of garden peas, he cross-pollinated them and observed and recorded the results. unfortunately, he published his findings in an obscure journal where they remained un-noticed for many years, but when they were unearthed about years after his death, gregor mendel was retroactively honoured as the father of a new science, genetics, which soon found many applications in clinical medicine, with the recognition of the fact that many inherited diseases were caused by genetic disorders. almost years after mendel' s death, other discoveries with great public health relevance include development of genetically modified sterile insect vectors of disease, genetically resistant strains of rice, wheat, and so on, and applications of genetic engineering to limit and even control and prevent some recessive inherited disorders. pasteur, henle, koch, virchow, and, soon after, battalions of bacteriologists and pathologists firmly established the fact that micro-organisms caused many diseases-the germ theory was a proven fact, not theory. however, many germ diseases require much more than germs before they can cause their worst damage. tuberculosis is caused by the tubercle bacillus acting in conjunction with poverty, ignorance, overcrowding, poor nutrition, adverse social and economic circumstances, and other enabling and predisposing factors. the diarrheal diseases, including cholera, are caused by various microorganisms, but these get into the gut when ingested with contaminated water or food, that is, they are really caused by poor sanitary and hygienic practices. by late in the th century, many of these factors had been clarified. the stage was set for the health reforms that included the sanitary revolution, the beginnings of a social safety net, provision of immunizations, nutritional supplements for school children, prenatal care for pregnant women, and other essential public health functions we take for granted years later. it required a dedicated army of public health workers to achieve all this. i have singled out and mentioned a mere handful of the public health pathfinders on the road to good health. many others could be added, but that would turn this brief chapter into a weighty monograph. often the physician−pathfinders used their own patients as experimental subjects for their path-finding discoveries. lind' s sailors, jenner' s young friends starting with james phipps, pasteur' s patient joseph meister, and all others known and unknown by name who provided the material for the great discoveries of robert koch and other members of the austrian and german schools of bacteriology, should be remembered and honored too. many others belong in their company: the great german pathologist rudolph virchow recognized that political action as well as rational science are necessary to initiate effective action to control public health problems; edwin chadwick and lemuel shattuck reported on the appalling sanitary conditions associated with the unacceptably high infant and child death rates that prevailed in th century industrial towns; william farr established vital statistics in england as a model for other nations to follow. and so the list grows from a handful of public health pathfinders to whole armies. more was needed than scientific discoveries. such discoveries had to be applied, and this often required drastic changes in the established social and economic order. so, other pathfinders appear on the road to health. they include politicians, administrators, journalists, creative writers, performing artists, and cartoonists. the journalists, creative writers, and artists who transmit the scientific concepts of public health to the general public and to the politicians are indispensable partners in the team that makes it possible for us to advance up the road to better health. the process continues in modern times with investigative journalism and tv documentaries. i have identified five essential ingredients of the processes that brought about the public health reforms called the sanitary revolution of the late th and early th century, and have shown that these five features are essential for the control of all public health problems. . awareness that the problem exists. john graunt began this process with natural and political observations. others consolidated his conceptual breakthrough, and it was applied to great effect after the establishment of formal national vital statistics in england and wales under the inspired leadership of william farr. by farr' s time, widespread literacy, the proliferation of daily newspapers, and word of mouth helped to enhance awareness among thoughtful people everywhere that there were massive public health problems in society at that time. modern computer-based record-keeping and effective health information systems with instantaneous worldwide notification of contagious disease outbreaks with public health significance continue to enhance the process. . understanding the causes. in the second half of the th century, understanding rapidly increased, as epidemiology and bacteriology, and nutritional and environmental sciences explored previously unknown landscapes of aetiology and pathogenesis. the new mass media-daily newspapers-propagated this understanding among literate people throughout the country. from the middle of the th century, news magazines and tv have ensured that knowledge of causal connections-smoking to cancer, diet and lack of exercise to coronary heart disease, alcohol-impaired driving to traffic fatalities, and many more-are very widely disseminated. this, however, has not necessarily led to effective control measures. . capability to control the causes. with astonishing speed, once the initial breakthroughs had occurred, sera and vaccines were developed to control many of the lethal microbial diseases that had plagued earlier generations. improved dietary practices, pasteurization of milk, improved personal hygiene and, above all, environmental sanitation to rid drinking water of polluting pathogens, all advanced rapidly in the final quarter of the th century and the first few decades of the th century. thus many ancient infectious disease scourges have been controlled, most dramatically being, perhaps , the eradication of smallpox. unfortunately, new infectious pathogens including the human immunodeficiency virus, viral tropical haemorrhagic fevers, the coronavirus of severe acute respiratory syndrome, and a score or more of others, have emerged to take their place . . . this is an essential prerequisite to the determination to act upon the problem. it is the most fascinating and challenging aspect of the essential features. this belief is the moral imperative that drives public health reforms. geoffrey vickers described the history of public health as a process of redefining the unacceptable-an endless process of identifying conditions, behaviors, and circumstances that individuals, communities, and cultures must no longer tolerate. throwing the contents of the chamber pot into the street, clearing one' s nostrils on the tablecloth, coughing and spitting on the living-room floor, all became unacceptable in the late th century. many people outside the boundaries of traditional medical science and public health practice played a role in this process. in the era of the great reforms of the th century, they included social reformers like edwin chadwick, journalists like henry mayhew and charles kingsley, novelists like charles dickens, cartoonists in punch and other periodicals-all of whom were aided by the rise of literacy in that period. collectively, they inspired a mood of public outrage that became an irresistible force for reform. in the second half of the th century, this sense of moral outrage found new targets-lighting a cigarette without permission in someone else' s home, carrying infant and child passengers in a car without safety equipment, dumping toxic industrial waste where it harms others, and more. yet, much else remains to be done. . political will. there is always resistance to change, there are always interest groups-often rich and powerful withal-who will do whatever it takes to obstruct necessary improvement. in the era of the sanitary revolution, it was the owners of water companies, factories, and tenement housing who resisted most vigorously. since the s it has been tobacco companies and a host of manufacturers of toxic petrochemical and other dangerous compounds released into the air and water. legislation and regulation are almost always necessary, and inevitably generate opposition. nevertheless, when the other four features-awareness, understanding, capability, and values-are in place, the political will to bring about reforms gathers momentum and usually succeeds eventually. these five essential ingredients required for public health reforms apply to several public health problems that have waxed and waned over time: tobacco addiction, impaired driving, domestic violence, child abuse, irresponsible domestic and industrial waste disposal, and so on. lately, mountainous barriers-of our own making-to maintaining our public health have appeared. the most formidable is a cluster of human-induced changes to global ecosystems and the global commons-the atmosphere, the oceans, wilderness regions, and stocks of biodiversity-that threaten all life and health on earth, not just the life and health of humans. another barrier is perhaps an inherent flaw in the human character that leads many individuals and national leaders to believe that disputes can be settled by violent means. currently, we have so many terrible weapons that violence done by them can and does cause immense suffering, innumerable deaths ( % or more of these deaths, as well as a similar proportion of permanent maiming and disability, are among non-combatants), and appalling damage to ecosystems, the environment, and the fabric of society. sadly, this is rarely recognized as a public health problem. the very first essential ingredient, awareness of the problem, is lacking. both these massive public health problems, in my view, are linked to the insatiable human craving for petroleum fuels, an addiction far more pervasive and dangerous to mankind and the earth than addiction to tobacco. so far in our only partially sentient and insightful civilization, this particular addiction is not even recognized as a public health problem. one public health problem that has been recognized is a worldwide pandemic of tobacco addiction and its many adverse effects on health and long life. recognition of this problem led the delegates to the world health assembly of to approve the framework convention on tobacco control. another universally recognized public health problem is the global pandemic of hiv/aids. tobacco addiction and the hiv/aids pandemic are both associated with the values of modern life and social behavior, including the marketing practices of transnational corporations. surmounting these barriers to health will require social, cultural, and behavioral changes and political action. i am an optimist. i believe that the pace of scientific advances will be maintained in the future, and that values will continue to shift in favor of essential changes towards global ecosystem sustainability. i do not know whether those who follow us will ever reach the ultimate summit or idealized who vision of halfdan mahler' s "health for all," but i am confident that they will continue to climb towards it. de contagione et contagiosis morbis et eorum curatione, libri iii natural and political observations mentioned in a following index and made upon the bills of mortality with reference to the government, religion, trade, growth, air, diseases and the several changes in the said city an inquiry into the causes and effects of the variolae vaccinae a treatise of the scurvy hippocratic writings. harmondsworth: penguin a green history of the world; the environment and the collapse of great civilizations the greatest benefit to mankind; a medical history of humanity from antiquity to the present a history of medicine, . primitive and archaic medicine on the mode of communication of cholera key: cord- - fs f b authors: youde, jeremy title: is universal access to antiretroviral drugs an emerging international norm? date: - - journal: j int relat dev (ljubl) doi: . /jird. . sha: doc_id: cord_uid: fs f b the international community appears to have embraced a new norm — that of universal access to antiretroviral drugs. the process by which this norm has found acceptance raises interesting questions about how norm entrepreneurs frame their arguments, the role of non-state actors in realizing a norm, and the importance of existent complementary norms. to understand the success of the norm of universal antiretroviral access, i examine the failure of an earlier health-related norm — that of universal primary health care. the campaign for universal antiretroviral access points to a need for a more nuanced understanding of norm evolution within the international community and a more holistic vision of which actors can facilitate the realization of a norm. most visible by the  (to provide million hiv-positive persons in the developing world with arv access by the end of ) and all by (to provide universal access by the end of ) campaigns, promotes providing access to these drugs regardless of ability to pay or country of residence. according to the precepts of this new norm, those infected with hiv in developing countries will have access to similar arvs as are available to people in developed countries. in , only , people in low-and middle-income countries had access to arvs. by , the number had jumped fivefold to . million. in addition, low-and middle-income countries offered arvs to at least half of their citizens in need (unaids : ) . all regions of the world have seen dramatic increases in arv availability. because they see it as the right thing to do, national governments, donor states, international organizations, nongovernmental organizations, private philanthropic organizations, and multinational corporations have come together in a coalition to further expand arv access to those individuals who do not have the ability to pay for these drugs. the emergence and apparent adoption of a new norm is, in and of itself, a remarkable event. even more remarkably, this new norm emerged less than years after an earlier attempt to promote universal health care for all failed to take hold within the international community. universal arv access is perhaps the most ambitious global public health campaign undertaken since the successful quest to eradicate smallpox. achieving this target will require international cooperation, vastly increased levels of financial assistance from developed countries, the active participation of international pharmaceutical companies, and rethinking and reapplying international intellectual property rights. perhaps more importantly, this new programme will require the international community to embrace a new norm that places the right to health and health care above concerns about the ability to pay and the sovereign right of states to manage their national health programmes. in their ambition, promoters set explicit deadlines for realizing this new norm's behavioural expectation. even though the  campaign failed to meet its target, the international community has remained energized around this idea of universal arv access and continues to move towards it -though its strategies for doing so are different from those generally recognized by the literature on norm evolution and acceptance. how has this new norm emerged and why has it emerged now? these two questions raise provocative and important concerns about the nature of norm entrepreneurs, the life cycle of norms in the international arena, and how norms evolve over time. in this case, universal arv access' norm entrepreneurs framed their campaign as an issue of individual human rights (an already existent and resonant norm) instead of as a collective public good (as the earlier promoters of universal health care for all did). reframing the norm allowed it to achieve greater success. most research on norm adoption and evolution focuses largely on the role of state actors and nongovernmental organizations, often presenting norms in relatively discrete terms. the case of universal arv access demonstrates the importance of actors who fall outside both traditional state structures and mass social movements. it also shows how norms adapt to changing international contexts to resonate with existing ideas. examining the case of universal arv access, we gain a nuanced view of norm adoption and internalization, a better appreciation for the range of actors important for promoting a norm, and an understanding of the importance of complementary international norms for successful norm adoption. to explain why the norm of universal arv access has emerged when earlier health-related norms failed, i begin by reviewing the literature on how norms evolve and take root within the international community. i then turn my attention to a case of a failed norm: universal primary health care, most prominently embodied in the alma-ata declaration and its attendant health for all by campaign. the third section focuses explicitly on universal arv access: where it came from, how entrepreneurs promoted it, and where we see evidence of its acceptance. i next look at the factors that allowed universal arv access to take root within the international community despite previous health-related norm failures. finally, i tie the specifics of universal arv access' history to our broader understanding of norm evolution, showing how it illustrates the need to reconsider the factors that promote the acceptance of international norms. finnemore defines norms as 'shared expectations about appropriate behaviour held by a community of actors ' ( : ) . a norm spells out how members of a group believe each other should act. it may or may not be explicitly codified, but members of a community understand the standards expected by the norm and hold each other accountable for conducting themselves in a manner consistent with it. it both constrains and enables action by defining the boundaries of acceptable behaviour (klotz : - ) . for example, the norm of sovereignty posits that one state does not have the right to interfere or intervene in the affairs of another state. states share an understanding that following the norm of sovereignty is appropriate behaviour for members of the international community, and those who violate the norm face possible sanctioning. such behavioural expectations are not always formalized by international law or treaties, though they may eventually be; rather, they operate most prominently as a shared social expectation. this social aspect is crucial, since norms can and will change as shared understandings change. to return to the sovereignty example, the behavioural expectations that go along with it today are radically different than those from previous eras (hall ) , and continue to evolve today (wheeler ; finnemore ) . norms go beyond simple behavioural modifications. states begin to reenvision their own identities as they embrace a norm. as states internalize new standards of behaviour, they come to new understandings of themselves. they answer the question 'who am i?' in a different manner. states are willing to forgo the costs associated with upholding normative precepts because these norms are constitutive of how the state sees itself. when a state fails to live up to these behavioural expectations, they justify their actions by referencing the norm itself. in an important sense, the state has violated its own understanding of who it is. instead of taking actions to abide by the rules, states take certain actions and engage in certain behaviours (and refrain from others) because 'good people do (or do not do) x in situations a, b, and c' (fearon : ) . they connect their preferences to policy choices and instruments in different ways as their self-understandings change (kowert and legro : ) . finnemore and sikkink ( ) offer a three-stage 'life cycle' for norms. in the first stage, a norm emerges and is championed by norm entrepreneurs. these entrepreneurs use their organizational platforms (such as a nongovernmental or intergovernmental organization) to promote the norm to members of the international community. they actively promote the norm as 'appropriate or desirable behavior in their community' (finnemore and sikkink : ) . they must persuade a critical mass of important actors to adopt and embrace the norm in order to reach the second stage -the norm cascade. during this second phase, an increasing number of states begin to adopt the norm, even in the absence of domestic pressures or economic self-interests to do so, because they increasingly see it as appropriate. if enough states do this, the norm becomes internalized in the third stage. it becomes 'common sense' and few would even question the behaviours expected by the norm. states abide by the norm and its behavioural expectations because that is just what members of the international community do. it becomes part of the state's sense of itself and its obligations to others. despite the efforts of norm entrepreneurs, not all norms find a home within the international community. scholars have identified three particular factors that appear to increase the likelihood of a norm's acceptance: if its precepts concern the protection of vulnerable populations (keck and sikkink : ) , if the norm contains clear, consistent rules with a previous history of observance (legro : - ) , and if the norm is both coherent and prominent (florini : - ) . if a norm is going to stick, states need to share an understanding of what a given norm means from both a behavioural and a constitutive perspective (van kersbergen and verbeek ) . norm entrepreneurs, according to most scholars, concentrate their attentions at the state level (finnemore and sikkink ; ingebritsen ) . they tailor their actions to encourage government policymakers to change their understanding of a particular issue, modify their behaviour, and incorporate the norm's idea into the state's overall identity. they try to get a critical mass of states to adopt, and eventually internalize, a norm in hopes of creating a norm cascade that leads to the norm becoming 'common sense'. while this focus on states is understandable, it ignores the plethora of actors whose actions can put a norm's ideas into practice. international organizations, nongovernmental organizations, private philanthropic organizations, and even multinational corporations play an ever-increasing role in providing services and taking on traditional governance roles. because of this, norm entrepreneurs have started to recognize the utility of targeting these groups as well. these nonstate actors may have financial resources beyond those available to states. they may also possess a greater level of legitimacy and lack much of the historical baggage of states. universal arv access is not the first health-related norm to be promoted to the international community. in the s and s, norm entrepreneurs sought to inculcate the norm of universal primary health care. despite strenuous efforts by some actors, the international community failed to embrace this norm. the reasons for universal primary health care's failure are highly instructive for understanding universal arv access' apparent success. , delegates from countries and international organizations met in alma-ata, ussr (now almaty, kazakhstan), from to september at the international conference on primary health care. the conference, organized by the world health organization and unicef, was the first international meeting devoted solely to primary health care. unanimously adopted, the alma-ata declaration listed eight crucial components of primary health care: education on health concerns and how to treat them, promoting proper nutrition, ensuring adequate supplies of clean drinking water and proper sanitation, providing maternal and child health care, including family planning, immunizing populations against major infectious diseases, preventing and controlling local endemic diseases, providing appropriate treatment for injuries and illnesses, and providing access to essential drugs (world health organization ) . in order to achieve these goals, the alma-ata declaration set specific targets for signatory states. these goals included: spending at least five per cent of gross national product on health, having per cent of children at the appropriate weight for their age, providing clean water within a -min walk of all homes and adequate sanitation either in the home or the immediate vicinity, making available trained personnel to attend to pregnancy and childbirth, and offering child care for children at least through one year of age (world health organization ) . these programmes sought to make essential health care accessible to all at an affordable cost and in line with a country's sovereign right to selfdetermination (world health organization ) . they afforded the majority of the country's population access to basic health care in line with locally determined needs. if states attained these goals and ensured the provision of primary health care, then it was hoped that the international community could meet its new goal -health for all by . the impetus for promoting this new norm grew out of changes in the international community. the s and s saw a great wave of decolonization and liberation throughout the third world, and new governments often came to power promising better health care for all their citizens. while initially many of these new governments took steps to improve health care, often with the support and aid of western states, services tended to be overly concentrated in urban areas and failed to reach rural areas. this meant that the majority of the population in many newly independent states still had limited access to health care facilities (hall and taylor ) . at the same time, an increasing number of studies criticized the idea that improved health in developing states was simply a matter of transferring western technologies and health care systems to new places. these studies called for a more holistic approach to health care that emphasized integrating health care into overall social development (cueto (cueto : . researchers and activists increasingly called for a 'bottom-up' approach to health care that focused on local needs and ensuring equitable access without an emphasis on large hospitals or expensive technologies (magnussen et al. : ) . china, tanzania, and venezuela successfully trained local personnel to provide essential basic health care programmes. these programmes offered basic yet comprehensive health care services to rural areas. for example, china's 'barefoot doctors' focused their energies on preventative care within the communities from which they were drawn and combined western and traditional cures for treatment (cueto (cueto : . inspired by their example, and drawing upon his own experiences with health care policies in developing countries, who director-general halfdan mahler of denmark called upon the international community to apply the lessons from these cases throughout the world. he urged who and unicef to ensure 'health for all' by changing both the provision of health care in developing countries and the role of developed states in ensuring this aim. the conference in alma-ata concentrated on spreading the message of health for all and devising strategies for putting this idea into practice. it is hard to underestimate how revolutionary the alma-ata declaration and its health for all by programme were. up to this point, health care had generally been considered the sovereign domain of states. previous cooperation on international public health issues, while it certainly existed, had been driven largely by specific disease outbreaks that threatened commercial interests. the international health regulations, adopted in , best reflect this concern. the ihr sought to 'ensure the maximum protection against the international spread of disease with minimum interference with world traffic' (world health organization ). states were required to report outbreaks of and take measures to prevent the spread of yellow fever, cholera, and plague -three diseases whose spread had long been associated with trade and travel (fidler and gostin : ) . the ihr thus made public health concerns subservient to economic relations among states, obligating national governments (and only national governments) to act only when disease threatened trade. the delegates to the alma-ata conference in functioned as norm entrepreneurs. they sought to create a change in how states viewed their responsibilities to their own citizens and those in other countries. much like the campaigns against slavery and apartheid (klotz ) , the alma-ata delegates engaged in normative debates that crossed ideological and economic lines. in the midst of the cold war, they sought to bring together democratic and communist states, encouraging them to look beyond their economic and political self-interest to embrace a greater good for the international community. by promoting the alma-ata declaration and health for all by , norm entrepreneurs sought to have states declare that public health was no longer simply a concern for national governments. they wanted national governments to set specific targets and adopt a normative framework that equated good governance with the provision of adequate health care standards. they encouraged states to move beyond reactive concerns with specific maladies and toward a more proactive holistic understanding of health and health care. universal primary health care's advocates framed their advocacy in relatively amorphous terms. as noted above, they spoke of decolonization, fairness, and development. they saw the provision of primary health care, especially in terms of having developed countries provide funding for such programmes, as an obligation owed to developing states by those who had already prospered. they also framed universal primary health care as a public good -one that required more generalized economic and social development. according to the norm entrepreneurs, the market could not adequately provide primary health care, so the state should do so (gostin : ) . the alma-ata declaration noted that health care inequalities were 'politically, socially, and economically unacceptable andytherefore, of common concern to all countries' (world health organization ) . interestingly, the norm entrepreneurs generally saw the push for universal primary health care as something that developed states should support largely on altruistic grounds. the declaration reads, 'all countries should cooperate in a spirit of partnership and service to ensure primary health care for all people' (world health organization ) . universal primary health care was a public good that developed states should provide in conjunction with developing states out of a sense of moral obligation and fairness and in the spirit of decolonization. this framing shared many affinities with calls for a new international economic order (nieo). indeed, the third clause of the alma-ata declaration specifically located universal primary health care within the broader calls for the nieo. working through the united nations conference on trade and development, developing countries put forward a number of proposals that sought to improve their terms of trade, increase economic assistance, reduce the north-south divide, and rewrite the international economic rules to favor developing states. these proposals all fell under the rubric of the nieo (murphy ) . representatives from developing states argued that the nieo would correct structural imbalances and allow developing states to receive the same benefits as developed states. critics countered that blaming developed states for the lack of development in poorer states was misplaced. they dismissed charges that western development was immoral or that developed states needed to sacrifice their wealth for the benefit of the less fortunate (johnson ). the acceptance of universal primary health care had the potential to be a major shift in the international community's normative framework, as it would fundamentally alter what it meant to be a 'good' state. it could alter the framework from one that emphasized individual responsibility for health care to one that gave governments primary responsibility for ensuring the public's health, both in their own countries and abroad (fidler : ) . despite the efforts of the alma-ata delegates, the goals of health for all by quickly ran into difficulties. it soon became obvious that the norm entrepreneurs were failing to attract a critical mass of supportive states who could further propel and promote the idea of universal primary health care within the international community. no norm cascade developed, and states did not alter their behavioural expectations of themselves or others. the very idea of primary health care itself came under attack as wildly unrealistic and inappropriate. government officials in many developed countries refused to believe that developing states could or should implement the wide-ranging programmes encompassed in health for all by (hall and taylor ) . instead, they proposed a new solution, selective primary health care (sphc), that would provide only those health care services that would have the greatest benefit to children under five (walsh and warren : - ) . primary health care's supporters, the norm entrepreneurs from alma-ata, saw sphc as a betrayal of the incipient norm's core beliefs. wisner ( ) alleged the sphc assumed that poor people were too ignorant to make proper health decisions, ignored existing local infrastructures and cultural practices, overlooked the role of grassroots efforts, and reinforced urban biases. hall and taylor remark, 'in effect, sphc took the decision-making power and control central to phc away from the communities and delivered it to foreign consultants with technical expertiseythese technical experts, often employed by the funding agencies, were subject to the policies of their agencies, not the communities ' ( : ) . sphc undercut the basic goals and ideals of health for all by and the alma-ata declaration. instead of encouraging broadbased participation and the equitable provision of health care to all groups within a society, the move towards sphc encouraged states to think in terms of economic self-interest. it removed the ability of developing states to determine their own needs and the best solutions to address those needs. sphc denied states policy autonomy. in the end, the norm of universal primary health care failed to gain much traction in the international community. its behavioural precepts failed to make an appreciable difference in state actions, and the shifts in identity associated with internalizing a norm never occurred. improvements in health care happened largely on an ad hoc basis with little international coordination or overriding guiding principles. what prevented the norm of universal primary health care from being adopted and internalized by the international community? a cursory examination highlights three key deficiencies. first, universal primary health care's supporters framed the norm as a collective public good. they called on developed states to provide a large outlay of funds to developing states en masse to right a perceived wrong. these pleas arose as the international community was dealing with a global recession, higher oil prices, and great economic uncertainty. few, if any, developed states were inclined to increase their foreign aid budgets. if anything, they were less inclined to provide assistance for health care in developing countries (people's health movement et al., : - ) . further, as part of providing this collective public good, developed states were being asked to allow developing states to independently determine their health care policies (hall and taylor ) . the frame for universal primary health care combined large financial outlays with little oversight, making it rather unpalatable to many developed states. second, the norm of universal primary health care failed to resonate with existing norms in the international community. norm entrepreneurs argued for universal primary health care as an element of a fundamental right to health at a time when the right to health was highly contested. their arguments that universal primary health care fit with a broader context of decolonization and fairness failed to find a perch. in the same way that the nieo largely failed to resonate and led to little but token actions, universal primary health care put forward an idealistic vision that did not resonate with broader trends in the international community at the time. additionally, conceptualizing health as a collective public good with a prominent role for national governments to provide services ran counter to the increasingly prominent rhetoric of neoliberalism and privatization that emerged in the late s and early s (thomas and weber ) . us state department officials also derided universal primary health care as 'too political' and feared how it could potentially alter the balance between themselves and the soviet union (werner ) . when director-general mahler called the soviet union 'a pioneer since the first days of its revolution more than years ago in placing health in the forefront of social goals and in linking its attainment with social justice and economic development' in his opening remarks at alma-ata (heyward ) , government officials in some states feared the relationship between universal primary health care and communism. murphy notes, 'american policy makers held that on fundamentals northern and southern views were incompatibleythey did not want to debate until both north and south had a single view of their common interests' (murphy : ) . interestingly, while american officials worried about how the ideological content of universal primary health care could promote communism and soviet ideals, the soviet union and people's republic of china vigorously disagreed with each other about the nature of universal primary health care (cueto ) . the disagreements between the two leading communist states further undermined universal primary health care's ability to find state supporters. finally, the norm entrepreneurs themselves were poorly placed to influence state governments or promote behavioural changes. universal primary health care's supporters targeted their appeals toward state governments, believing them to be the key to this norm being embraced by the international community. many were delegates to the alma-ata conference. most were bureaucrats either within their national health ministries or the world health organization. they may have had the technical expertise to understand the important of universal primary health care and perhaps the experience to implement it, but they lacked the political sway within governments to get them to reassess their behaviours and identities. in other words, they may have been norm entrepreneurs, but they were poorly placed norm entrepreneurs who lacked the ability to persuade enough others to adopt the norm. health ministries unfortunately have a tendency to be political backwaters with little influence beyond technical matters (vaughan et al. ) . the world health organization also lacked the stature to significantly affect international debates over universal primary health care. it lacked significant financial resources and, despite a near-universal membership, its political clout among member-states was negligible. the world health organization's low status was largely a reflection of the relatively low priority afforded to health within the international community. most states considered health to be a national responsibility and envisioned a limited role for the international community. the world health organization also sought, for much of its history, to consciously avoid political battles so as to avoid antagonizing its members (godlee ) . when it did try to take a more assertive role with universal primary health care, it faced the very real threat of having states like the united states withdraw its funding (walt ) . with the failure of health for all by , international health norms largely fell off the global agenda. the international community came together to combat various diseases, but no overarching normative ideas concerning the behavioural obligations of states to others within the international community received much attention. the  initiative changed things, bringing the idea of the norm of universal arv access to the forefront of the international community. on september , the who, unaids, and the global fund to fight aids, tuberculosis, and malaria announced a new initiative to combat the failure to deliver arvs to people with hiv in developing countries. that year, unaids estimated that six million hiv-positive people in the third world required arvs, but less than eight per cent actually received them. while per cent of those in need in central and south america had access to arvs, only two per cent of those in africa, the continent hardest hit by the aids epidemic, did (world health organization/unaids : - ) . this new programme sought to correct that. it pledged to provide a sustainable and reliable supply of arvs to three million people in the developing world, half the number who needed the drug, by the end of . although the leaders of this effort acknowledged that it was an incredibly ambitious goal, they based their calculations on an article published in in science. the article's authors cautioned that reaching this target would require optimal levels of both financing and technical capabilities. still, they considered it doable (schwartla¨nder et al. ) -as did, apparently, who and unaids. who and unaids declared the lack of arv access to be a global health emergency and an issue that urgently needed to be addressed. the  initiative did not create calls for universal arv access by any means (see, e.g. farmer and headley and , but it focused them and gave them far greater prominence within the international community. instead of being a relatively amorphous call to help people with aids, this new norm framed its calls for action in relatively concrete terms, of providing something tangible to individuals who could not otherwise acquire it, as a human right. by declaring a health emergency, though, the  initiative's promoters hoped to 'propel action and upend ''business as usual'' attitudes'. this new programme would 'demand new commitment and a new way or working across the global health community' (world health organization/unaids : ). to achieve this commitment, they situated the call within a framework of country ownership, human rights, and equity. not only would success require high-level political commitment but also the attendant financial outlays would also be quite high. when announcing the new programme, who estimated that it would cost at least us$ . billion to achieve the target (world health organization/unaids : ). however, the focus was not on the cost, it was on the realization of the norms of respect for universal human rights. who also saw the initiative as promoting the un's human rights agenda in two ways. first, the universal declaration of human rights declares that all people have the right to the highest possible standard of health -a promise reaffirmed to explicitly include hiv/aids during the united nations special session on hiv/aids in . second, the initiative pledged to pay special attention to vulnerable groups who may have limited access to treatment and prevention programmes. by emphasizing equity, the initiative sought to overcome economic barriers that had prevented most people in developing nations from being able to afford arvs. it utilized the ideas of access to essential medicines and non-discrimination in the provision of care evident in the alma-ata declaration. harris and siplon identified a growing recognition, by developed states, of a norm promoting international assistance to developing states as 'the right thing to do ' ( : ) . in their paper, schwa¨rtlander et al. referenced the movement for realizing the right to health in africa as emblematic of the international community's growing respect for this ideal ( : ). the  initiative's own materials were even more explicit. on its website, the initiative proclaimed that its efforts were 'a step towards the goal [sic] of making universal access of hiv/aids prevention and treatment accessible for all who need them as a human right' (world health organization n.d. a; emphasis added). from the earliest days, activists and organizations connected the drive for universal arv access back to the earlier efforts to promote health as a human right. tactically, norm entrepreneurs for universal arv broadened their reach. they did not solely focus on states as the entities responsible for realizing this norm. instead, they called on international organizations, nongovernmental organizations, multinational corporations, and private philanthropic groupsin addition to national governments -to work together. the norm entrepreneurs explicitly recognized this connection, noting, ''' by '' is a target that many organizations are working together to achieve, including national authorities, un agencies, multilateral agencies, foundations, nongovernmental, faith-based and community organizations, the private sector, labour unions and people living with hiv/aids. to succeed, full support and participation from all partners and governments are needed' (world health organization n.d. b). this shift moved the norm from being a collective public good whose realization depended solely on developed states to being targeted toward individuals with diffuse responsibility for protecting the human rights of those in need. such a frame resonated with the increasing international embrace, for better or worse, of public-private partnerships and more holistic interpretations of governance (see bovaird ; flinders , therien and pouliot for detailed discussions on the evolution of public-private partnerships and their associated costs and benefits). spearheading this drive, lee and piot played particularly important roles in mobilizing commitment, attracting international attention and support, and offering guidance. they served as norm entrepreneurs in every sense of the term. they made it their mission to try to convince donors, both governmental and nongovernmental, that the  initiative was in fact achievable. they had to convince a diverse array of actors to work together to find ways to lower the cost of arvs while still allowing the pharmaceutical manufacturers to earn a profit. they needed to get states to re-envision who they were and how they interacted with the rest of the world. they also had to convince states, private organizations, and multinational corporations that this was an issue of individual human rights as well as one in which they could play a significant role. at the end of the  initiative's timeframe, only . million people in developing countries were receiving arv treatment. this was less than half of the initiative's publicly stated goal. in many ways, this was still a remarkable success. in the span of two years, over one million new people gained access to life-prolonging drugs. over per cent of those who needed arvs in the developing world now had them -a significant improvement over the seven per cent who had them in . eighteen countries announced that they had met or exceeded their arv treatment targets (world health organization/ unaids : ). these are stunning accomplishments over an incredibly short period of time. these stunning accomplishments cannot diminish the fact that who and unaids failed to meet their goals. they pledged to provide arvs to half of the people in developing countries who needed them (a number that continued to grow over the two-year period from ), and they failed to do so. even with greater access to arvs, the worldwide rates of hiv infection continued to increase -meaning that even more people now required arv therapy and did not have access to it. critics lambasted the programme for being overly optimistic, relying on unrealistic modelling, and failing to properly coordinate programmes among the myriad of actors involved (economist ) . others noted that national aids control programmes often fell prey to petty turf battles and corruption, making them ineffective (itpc : - ) . despite this apparent failure, the basic norm of universal arv access continues to hold sway within the international community. state governments, international organizations, nongovernmental organizations, private philanthropic organizations, and multinational corporations have repeatedly reaffirmed their belief in the norm and pledged additional funds (though still short of what is necessary) toward its realization. given the apparent failure of the  initiative, it was realistic to assume that the norm of universal arv access was dead. its proponents had set an explicit target with a very explicit timeframe -and they failed to achieve this. remarkably, this was not the case. instead of walking away from failure, the international community has embarked on an even more ambitious goal -all by . all by is the latest attempt to put the emerging norm of universal access to arvs into practice. like the  initiative, all by combines the efforts of state and non-state actors to provide universal arv access as a constituent element of individual human rights. the central goal of all by is universal access to arv treatment. this means, according to most definitions, ' per cent of all people in urgent need of treatment are receiving it' (avert n.d.) . based on current projections, the best estimate is that the all by programme will need to get million people worldwide on arvs by the end of to meet its goals (as a shorthand, some also call this program  ). as with the  initiative, the leaders of all by explicitly state that this effort is designed to mobilize stakeholders, maintain momentum, and encourage states to contribute. the norm entrepreneurs are using their organizational platforms within who and unaids to encourage the adoption and internalization of a new norm. while expressing regret at its inability to achieve its initial target, the who and unaids' final report on the initiative discussed ways to rectify the problems it faced. the report argued the end of the initiative was just the beginning toward ensuring universal arv access for all. this provides evidence for the internalization of the norm through rhetoric and changes in constitutive identities. failure to achieve and the behaviours associated with it were explained within the context of the norm itself. 'the '' by '' target needs to be seen as an interim step toward the ultimate goal of universal access to antiretroviral therapy for those in need of care, as a human right, and within the context of a comprehensive response to hiv/aids' (world health organization /unaids : ) . the g nations, the very nations that provided the vast majority of funding for the programmes that came under the  initiative's umbrella, pledged in july to work toward universal access to arvs worldwide by . at the g summit in gleneagles in july , the leaders of the world's largest economies pledged at least an extra us$ billion in aid annually, part of which would be specifically pledged for universal arv access (office of the prime minister ). two months later, the united nations passed a resolution calling on member states to work toward this goal and to pledge the necessary resources (avert n.d.) . in , the un high-level meeting on aids produced a resolution that stated in part, '[we commit] to pursue all necessary efforts to scale up nationally driven, sustainable and comprehensive responses to achieve broad multisectoral coverage for prevention, treatment, care and support, with full and active participation of people living with hiv, vulnerable groups, most affected communities, civil society and the private sector, towards the goal of universal access to comprehensive prevention programmes, treatment, care and support by ' (united nations ) . african heads of state made a similar pledge in may at a summit in abuja, nigeria (agence france-presse ) . the clinton foundation and the gates foundation have both continued their arv access efforts and have expanded them beyond their initial plans. the international community has clearly embraced the normative rhetoric of universal arv access, tying it to the realization of individual human rights and a broadened conceptualization of governance. the united nations' declaration of commitment on hiv/aids resolved that 'access to medication in the context of pandemics such as hiv/aids is one of the fundamental elements to achieve progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health' (united nations ) . within months of the unveiling of the  initiative, all member states of the who publicly endorsed the program and the norm contained within it. they publicly pledged to aggressively work toward the realization of this goal and, in a broader sense, to ensure that all those who needed arvs could get them. the un economic and social commission for asia and the pacific passed a resolution that called on states in the region to scale up their public health programs specifically in response to the  initiative (unescap ) . in may , over delegates from around the world came together in geneva to coordinate efforts to rapidly scale up efforts to expand access to arvs across political, economic, and religious lines. the us president's emergency plan for aids relief (pepfar), its primary aids programming effort, strongly emphasizes antiretroviral therapy (and its attendant infrastructure), considering it an integral part of its aids programmes and part of the us' obligation as a leading member of international society (office of the global aids coordinator ). when announcing pepfar during his state of the union address, us president george w. bush noted, 'because the aids diagnosis is considered a death sentence, many do not seek treatment. almost all who do are turned away. a doctor in rural south africa describes his frustration. he says, ''we have no medicines. many hospitals tell people, you've got aids, we can't help you. go home and die.'' in an age of miraculous medicines, no person should have to hear those words' (bush ) . this statement received a tremendous amount of applause. making this proclamation during his most important speech of the year shows that the norm of universal arv access is at least fomenting rhetorical changes. four years later, when bush called on congress to reauthorize pepfar by providing us$ billion over the next five years, he highlighted the normative aspects of the programme. acknowledging the costs and the number of people affected by the programme, he emphasized, 'the statistics and dollar amounts i've cited in the fight against hiv/aids are significant. but the scale of this effort is not measured in numbers. this is really a story of the human spirit and the goodness of human heartsyour citizens are offering comfort to millions who suffer, and restoring hope to those who feel forsaken' (bush ) . evidence also shows that recipient states internalized this new norm. within months of the initiative's debut, countries approached who, asking for assistance through this new programme (world health organization : ). these states sought to make the changes in their policies and infrastructure that would allow them to expand the ability of their citizens to access these drugs. they publicly acknowledged that they did not have the resources to enact such a programme, yet by approaching who, they also publicly acknowledged their desire to work with the international community to implement the norm's programme. further, nearly every country has created a country coordinating mechanism (ccm) to receive funding from the global fund and coordinate aids activities. these ccms explicitly incorporate representatives from the public and private sectors to promote the incorporation of all relevant voices (global fund to fight aids, tuberculosis, and malaria n.d.). these efforts show a willingness to adapt state structures in order to facilitate the provision of arvs. non-state actors play an increasingly important role in realizing the behavioural expectations of this new norm. international organizations like the world health organization and the joint united nations program on aids (unaids) serve as conduits of information for the international community. they gather and disseminate data, provide technical resources to actors trying to implement arv access programmes, and sponsor international meetings to facilitate networking. while they also provide some direct funding, they largely focus their energies on supporting the technical and logistical resources needed to bring the norm's objectives to fruition. for funding, the global fund to fight aids, tuberculosis, and malaria emerged in . the global fund is an independent organization, with representatives from donor and recipient governments, nongovernmental organizations and the private sector, with responsibility for funding aids-related programmes. it explicitly does not implement programmes on its own. instead, it provides a centralized source for donors to contribute money and recipients to receive grants to implement programmes (van kerkhoff and szleza ) . unique among most international bodies, the global fund relies upon funds from national governments, nongovernmental organizations, private philanthropies, and the sale of specially branded consumer products (dyer ) . programmes funded by the global fund may be implemented by governments or nongovernmental organizations, broadening the realm of actors who can help realize the behavioural expectations of this new norm. private philanthropies and multinational corporations have also played a significant role in working toward universal arv access' behavioural precepts. the clinton foundation, former us president bill clinton's organization, has focused its energies on transforming the economic incentives for pharmaceutical companies. recognizing that these companies will not produce arvs without an ability to make a profit, the clinton foundation has helped to aggregate demand for arvs. it has sought to 'transform the antiretroviral marketplace from a low-volume, high-margin market to a high-volume, lowmargin market that serves millions of hiv/aids patients' (clinton foundation n.d.) . this strategy significantly reduces the price for arvs while still allowing generic and branded pharmaceutical manufacturers to recoup their investment in developing arvs. the foundation has forcefully argued that it has not asked for charity, but rather sought to ensure supply at an affordable price in the face of large demand (rauch ) . the bill and melinda gates foundation, the world's wealthiest philanthropic organization, collaborated with the government of botswana and the pharmaceutical company merck to create the african comprehensive hiv/aids partnership. this arrangement brings together the financial resources of the gates foundation, the manufacturing and distribution capabilities of merck, and the infrastructure of botswana to deliver arvs to those in need (gates foundation ; ramiah and reich ) . these two efforts demonstrate the significant role that non-state actors play in actualizing universal arv access. it is indeed true that, even with the diversity of actors involved, international funding for universal arv access has remained far below what experts and norm entrepreneurs claim is necessary. six months before the initiative formally ended, 'unaids estimates that at least an additional us$ billion above what is currently pledged is needed for global hiv/aids efforts over the next three years' (world health organization : ; emphasis added). african governments pledged to increase their own budgetary outlays for health programmes within their own borders. by , they promised to devote per cent of their national budgets to health (including hiv/aids programmes) -but none of them met this target by 's end (itpc : ) . funds from some donor states like the united states have come with conditionalities that have hampered their ability to be accessed in a timely and efficient manner. despite this reality, the commitment to realizing the norm of universal arv access appears to remain intact. stephen lewis, the un's special envoy for hiv/aids in africa, proclaimed, 'mind you, i can even now hear the curmudgeonly bleats of the detractors, whining that we will fall short of the target of three million in treatment by the end of this year. tell that to the million people who are now on treatment and who would otherwise be dead. the truth is that the by initiative -which, i predict, will be seen one day as one of the un's finest hours -has unleashed an irreversible momentum for treatment' (un news service ; emphasis added). it is highly significant that no state ever predicated its behaviour on a rejection of the norm. no state stated that universal arv access was undesirable or unworthy. questions did arise as to how best to provide these medications to people in challenging environments and ensuring compliance with the drug regimen's requirements. even these discussions, though, referenced back to the emerging norm of universal arv access. the issue was not one of the appropriateness of universal arv access; it was one of delivery. these actions do not mean that the debates over universal arv access are over. the battles over funding levels alone demonstrate the continued discussion. those debates, though, are not evidence of the lack of a norm. van kersbergen and verbeek ( ) remind us that the details over implementing a new norm's behavioural expectations can continue for a while and even be contentious. what we see with universal arv access is a debate over how to realize the norm, not over whether the norm is appropriate. whereas the attempts to promote a norm of universal primary health care got bogged down in debates over its very appropriateness, universal arv access' norm entrepreneurs appear to have successfully convinced a significant portion of the international community that the basic idea is sound. the norm for universal arv access obviously picks up on some of the same themes as the earlier push for universal primary health care, yet it appears to be having more success in establishing itself and being internalized by the international community. what explains the difference? i suggest two important differences: the norm entrepreneurs themselves and the international normative context. first, norm entrepreneurs themselves make a difference, and this appears particularly true for aids-related issues. in the s, many national governments specifically cited the personal lobbying of jonathan mann, then the head of the united nations' global program on aids, as the reason they increased their contributions to aids control efforts (gordenker et al. : ) . in the case of universal arv access, the effort was really spearheaded by lee, piot, and feachem (mann died in a plane crash in ) . these three had the connections and experience that allowed them access to the highest levels of governments. they also took a very intense personal interest in the promotion of this newly developing norm. all three men had impressive resumes working with hiv/aids and ensuring access to health care in developing nations. lee, who himself died suddenly in may , devoted one of his last speeches to building on the lessons from the  initiative to promote universal arv access (lee ) . in addition, these three key norm entrepreneurs had impressive organizational bases -the world health organization, unaids, and the global fund to fight aids, tuberculosis, and malaria, respectively -from which to promote their norm and encourage states to adopt it. successful norm entrepreneurs can benefit from such a platform. mahler, during the promotion of health for all by , held the same position as lee, so what explains the difference? for one thing, his was a more solitary voice. mahler was essentially the only leader on the international stage promoting universal primary health care. this made his task more daunting. second, international health organizations have greater prominence today than they did in the s and early s. the international community came together to form the global fund, unaids builds on the strengths of multiple un-affiliated agencies, and the who has received greater attention and respect thanks to its successful handling of crises like sars, avian flu, and the asian tsunami recovery efforts. in addition to the efforts of lee, piot, and feachem, a wide range of nongovernmental organizations took an active role in promoting the norm. these groups put pressure on their governments to live up to their promises, provided research to demonstrate the benefits of greater arv access, and worked to forge seemingly odd political coalitions (witness the alliance of irish rock star bono and conservative former us senator jess helms) to promote their cause. groups like the treatment action campaign, healthgap, and the international treatment preparedness campaign have forced governments around the world to respond to the burgeoning movement for universal arv access. the gravitas of figures like bill clinton, nelson mandela, and bill gates adds even more momentum to the calls for universal arv access. in addition, these groups regularly interacted with one another, sharing strategies and collaborating on international efforts. with norm entrepreneurs working from above (at the international organization level) and below (at the nongovernmental organization level), national governments found it harder to resist. second, the international normative environment has changed in a way more favourable to the embrace of universal arv access. cold war tensions, which partially bedeviled debates over universal primary health care, disappeared but it would be a mistake to attribute too much to this change. more importantly, universal arv access has also benefited from the internalization of related complementary norms within the international community. there is increasing recognition of health as a human right (mann et al. ) , which itself builds upon the embrace of universal human rights. farmer has written extensively and eloquently on the connections between health and human rights. he sees medical workers as the new vanguard for promoting human rights, as their actions can actually put the notion of health as a human right into practice. addressing health concerns in an unbiased manner necessarily involves the recognition of social and economic rights when healthcare workers provide these services for their fellow human beings without regard for ability to pay (farmer : ) . in this way, health promotes human rights in a less overtly political manner. within the framework of health as a human right, a number of groups specifically cite hiv/aids as a human rights issue -and a number of states have internalized this framework (youde forthcoming). if states agree with the idea that health is itself a universal human right and that aids, in particular, is a human rights issue, then it is a small stretch to embrace the notion that providing access to the drugs that combat aids is itself an important normative issue. by avoiding frames that emphasize providing collective goods for developing countries and instead focusing on realizing individual rights through broadbased participation, universal arv access' supporters positioned their ideas to resonate with existing international norms. this new norm then became seen as a natural extension of already-existing ideas. it fit in with prevalent norms about individual human rights and public-private partnerships. the growing discussions around health as a human right allows proponents of the norm of universal arv access to frame their issue in a manner that resonates with government officials and the public. advocates can use frames that match with ideas or images already present in a culture to gain support. this can be particularly important when high costs are involved. the proper frame encourages policymakers to look past their financial concerns to understand how that frame matches with an underlying constitutive identity. busby ( ) uses frames to understand how jesse helms, a conservative us senator, and bono, the irish rock star, came together to support debt relief for poor countries when the issue was framed as one of biblical justice. making this appeal in the context of an existing belief -a shared christian faith, in this case -allowed the issue of debt relief to move forward in spite of the financial cost. in the same way, universal arv access' advocates could draw upon the growing recognition that developed states have an obligation to help those less fortunate and that health is a fundamental aspect of dignified human existence (mann et al. ; harris and siplon ) . the international normative environment was thus primed to be more receptive to a call for widespread drug access in the early s that was not present at earlier junctures. in many ways, universal arv access' path to acceptance has so far followed a path similar to that previously trodden by the norm of human rights. like universal arv access, human rights norms not only prescribe certain behaviours but they also allow states who internalize these norms to define themselves as liberal (risse and sikkink : ) . human rights norms did not simply emerge on their own, and states did not adopt them thoughtlessly. instead, the diffusion of human rights norms depended upon a sustained network of domestic and international networks that could connect to policymakers and international regimes. these networks put pressure on states, helped redefine the international normative context in a manner amenable to the embrace of these norms, and empowered actors to appeal for recognition of the norms (risse and sikkink : ) . activists framed human rights norms in ways that would resonate with existing domestic political cultures in various countries (risse and ropp : ) . some states may have initially embraced human rights norms for instrumental reasons (risse and sikkink : ) , but this process itself encouraged states to redefine their identities. human rights norms went from being policy choices to constitutive elements of how states saw themselves and their respect for basic human morality (donnelly : ) . human rights norms depended upon a combination of norm entrepreneurs and a favorable international normative context to succeed -the same processes that have assisted with the internalization of the norm of universal arv access. the moves toward universal access to arv therapy as embodied by the  initiative and all by programme represent the emergence of a new international norm born out of the ashes of an earlier failed attempt to inculcate a norm of universal primary health care access. it demonstrates how norms can evolve within the international community and take on new life when international political situations and norm entrepreneurs change. states are working toward universal arv access despite the very high costs and the potentially negative consequences for western pharmaceutical companies. to uphold the norm, they engage in actions that may not be economically profitable and explain their failures to live up to the norm's obligations in terms of those obligations themselves. this is more than just a story about arvs, though. the emergence of universal arv access enriches our understanding of how and why the international community embraces certain norms. it has shown the importance of moving beyond a state-centric view of norm emergence and adoption. nonstate actors, such as nongovernmental organizations, philanthropic groups, and multinational corporations play an increasingly important role in international governance, and that role extends to their influence on international norms. universal arv access also makes clear the importance of complementary norms for successful adoption. universal primary health care failed, in part, because it did not resonate with dominant norms within the international community at the time. finally, universal arv access highlights just how important framing by norm entrepreneurs can be. universal arv access' supporters cast the issue as one of individual human rights being realized by a broad-based coalition of state and non-state actors. this worked far better than the broader collective public good supported by developed states frame employed in the discussions around universal primary health care. universal arv access is indeed an ambitious goal but it could have immense international benefits. by internalizing this norm, states are redefining their obligations to each other when it comes to providing health care. they are establishing new standards of behaviour, standards by which their actions will be judged by others. international ethical obligations are changing for the better of humanity. earlier efforts to inculcate progressive norms that ensure access to health care may have failed, but contemporary norm entrepreneurs demonstrate that it is indeed possible to foster international health-related norms. african leaders pledge more access to aids, malaria treatment aids treatment target and results: all by public-private partnerships: from contested concepts to prevalent practice bono made jesse helms cry: jubilee , debt relief, and moral action state of the union address president bush announces five-year, $ billion hiv/aids plan hiv/aids initiative: drug access the origins of primary health care and selective primary health care preface the social construction of international human rights new fund-raising scheme fuses profit with philanthropy spin doctors infections and inequalities: the modern plagues pathologies of power: health, human rights, and the new war on the poor what is identity (as we now use the word)?', unpublished manuscript disease and globalized anarchy: theoretical perspectives on the pursuit of global health the new international health regulations: an historic development for international law and public health national interests in international society the purpose of intervention international norm dynamics and political change the politics of public-private partnerships the evolution of international norms working with botswana to confront its devastating aids crisis global fund to fight aids, tuberculosis, and malaria (n.d.) 'country coordinating mechanisms who in retreat: is it losing its influence? health for all beyond : the demise of the alma-ata declaration and primary health care in developing countries' international relations and global ethics of hiv/ aids roadblocks on the road to treatment: lessons from barbados and brazil report of the alma-ata conference scandinavia's role in world politics missing the target: a report of hiv/ aids treatment access from the frontlines the new international economic order', university of chicago graduate school of business selected papers no norms in international relations: the struggle against apartheid transnational activism and global transformations: the anti-apartheid and abolitionist experiences norms, identity, and their limits: a theoretical reprise opening remarks at the consultation on aids and human resources for health which norms matter? revisiting the ''failure'' of internationalism comprehensive versus selective primary health care: lessons for global health policy the emergence of the nieo ideology gleneagles : chairman's summary people's health movement, medact and global equity gauge alliance ( ) global health watch building effective public-private partnerships: experiences and lessons from the african comprehensive hiv/aids partnerships (achap) this is not charity the socialization of international human rights norms into domestic practices: introduction international human rights norms and domestic change: conclusions resource needs for aids the global compact: shifting the politics of international development? the politics of global health governance: whatever happened to ''health for all by declaration of commitment on hiv/aids', general assembly resolution a/res/s- / draft political declaration - high-level meeting on aids regional call for action to enhance capacity-building in public health. resolution / un goal of treating million hiv/aids victims by unlikely to be met linking local knowledge with global action: examining the global fund to fight aids, tuberculosis, and malaria through a knowledge system lens the politics of international norms: subsidiarity and the imperfect competence regime of the european union can ministries of health support primary health care? some suggestions for structural reorganization and planning selective primary health care: an interim strategy for disease control in developing countries who under stress: implications for health policy elusive promise' saving strangers: humanitarian intervention and international society gobi versus phc? some dangers of selective primary health care the by initiative world health organization (n.d. b) 'partnerships: working together for declaration of alma-ata world health organization ( ) international health regulations progress on global access to hiv antiretroviral therapy: an update on '  treating million by : making it happen progress on global access to hiv antiretroviral therapy: a report on ''  '' and beyond hiv/aids as a human rights issue emily atkinson provided invaluable research assistance for this article. i also wish to thank brent steele, tracy slagter, and jird's anonymous reviewers and editors for their thoughtful comments. any errors, of course, are solely my responsibility. key: cord- -s jrbvn authors: katsaliaki, k; mustafee, n title: applications of simulation within the healthcare context date: - - journal: j oper res soc doi: . /jors. . sha: doc_id: cord_uid: s jrbvn a large number of studies have applied simulation to a multitude of issues relating to healthcare. these studies have been published in a number of unrelated publishing outlets, which may hamper the widespread reference and use of such resources. in this paper, we analyse existing research in healthcare simulation in order to categorise and synthesise it in a meaningful manner. hence, the aim of this paper is to conduct a review of the literature pertaining to simulation research within healthcare in order to ascertain its current development. a review of approximately high-quality journal papers published between and on healthcare-related simulation research was conducted. the results present a classification of the healthcare publications according to the simulation techniques they employ; the impact of published literature in healthcare simulation; a report on demonstration and implementation of the studies’ results; the sources of funding; and the software used. healthcare planners and researchers will benefit from this study by having ready access to an indicative article collection of simulation techniques applied to healthcare problems that are clustered under meaningful headings. this study facilitates the understanding of the potential of different simulation techniques in solving diverse healthcare problems. healthcare needs grow and healthcare services become larger, more complex and costly (eveborn et al, ; wand, ). moreover, the intrinsic uncertainty of healthcare demands and outcomes dictates that healthcare policy and management should be based on the evidence of its potential to tackle these stochastic problems. it seems apparent that computer modelling should be valuable in providing evidence and insights in coping with these systems. they can be used to forecast the outcome of a change in strategy or predict and evaluate the implications of the implementation of an alternative policy (wierzbicki, ) . the use of modelling in healthcare is not limited to the management of activities necessary to deliver care alone. it is also used for the study of several topics related to healthcare, for example, air pollution, pharmacokinetics and food poisoning. in this paper, we aim at profiling studies that have designed, applied, described, analysed or evaluated healthcare problems with the use of simulation modelling. computer simulation is a decision support technique that allows stakeholders to conduct experiments with models that represent real-world systems of interest (pidd, ) . it can be used as an alternative to 'learning by doing' or empirical * correspondence: k research (royston, ) . furthermore, simulation modelling gives stakeholders the opportunity to participate in model development and, hopefully, gain a deeper understanding of the problems they face. as a result, decision makers and stakeholders can gain a new perspective on the relationships between the given parameters, the level of systems' performance, the cost-effectiveness and its quality, or risk association. in the field of operations management, simulation is recognised as the second most widely used technique after 'modelling' (amoako-gympah and meredith, ; pannirselvam et al, ) . thus far, there have been a number of reviews in the literature on the applications of simulation to health. fone et al ( ) have conducted a systematic review of the use and value of computer simulation methods in population health and healthcare. reviewed the application of a diverse range of simulation techniques in healthcare settings. brennan and akehurst ( ) and barrios et al ( ) considered the application of simulation in the economic evaluation of health technologies and health products as well as a proposed method for the evaluation of pharmacoecomonic models (hay, ) . dexter ( ) includes a review of computer simulation and patient appointment systems. a number of reviews have focused on the applications of discrete-event simulation (des) in healthcare in general (england and roberts, ) , and more specifically in health clinics (jun et al, ) and healthcare capacity management (smith-daniels et al, ) . gives a personal review of the use of discrete event simulation in health among other fields. however, most reviews limit themselves to either a single application area or/and a single simulation technique. most of the current reviews lack the breadth of simulation techniques, the width of applications coverage and are published in outlets of different fields (eg medical, or, health informatics journals, etc), thus potentially hampering the widespread reference and use of such studies. hence, the purpose of this review is to fill these gaps and categorise and synthesise academic literature pertaining to the use of computer simulation in health problems (a) over a number of unrelated publishing outlets, (b) with a broader scope of simulation techniques and (c) in a variety of health applications. this would, in turn, help in ascertaining the current development in the field of healthcare simulation. in light of the above, by sampling publications pertaining to the application of simulation in the healthcare domain, we hope to realise the following objectives: ( ) to classify publications according to the simulation methods they employ; ( ) to determine the healthcare problems often investigated by these methods and to analyse their trends; ( ) to identify the impact of published simulation research in the healthcare context; ( ) to monitor results' demonstration and implementation; ( ) to identify funding sources for healthcare simulation studies; ( ) to identify software associated with the studies and show their frequency of use. in order to achieve these objectives, we have conducted a review of articles published during the period - . the main objective of this review is to offer a broad and extensive picture of the role of simulation techniques in healthcare. to the best of our knowledge, objectives ( ) and ( ) have not been previously investigated in a single study for all four selected simulation techniques in the health sector, and objectives ( ) to ( ) have not been presented in a published source-with the exception of england and roberts ( ) who presented similar results for discrete event simulation and system dynamics over years ago. it is hoped that the findings of our analysis will be beneficial to the community of simulation and healthrelated academics and practitioners. the remainder of this paper is structured as follows. the next section ('simulation modelling') provides a discussion of the different simulation methods selected for this study. the methodology employed for the research is explained under the 'research methodology' section. the section on 'research paradigm' categorises the applications of simulation under various simulation techniques and healthcare problems-this fulfils objectives ( ) and ( ) . this is followed by the 'research impact' section (fulfils objective ) that identifies some important papers that have been reviewed in our study and measures their impact through a citation-based analysis. the section on 'results implementation, funding sources and analysis of simulation software' presents statistics pertaining to these variables, and thereby fulfils objectives ( ), ( ) and ( ) . the penultimate section presents a 'discussion' of the findings of this study, and the paper concludes with 'conclusions and further reflections' that outline the limitations of our approach and reflect on the contribution of this work. the simulation modelling techniques that were found appropriate for the purposes of this study are monte carlo simulation (mcs), discrete-event simulation (des), system dynamics (sd) and agent-based simulation (abs). journal papers included in this study have been selected based on the criteria that the papers report on the use of one or more of these simulation techniques in the healthcare settings. the choice of simulation techniques was made through interaction with experts in this area but was also backed by the review of jahangirian et al ( ) of simulation in business and manufacturing. the latter identifies the following simulation techniques: des, sd, abs, mcs, intelligent simulation, traffic simulation, distributed simulation, simulation gaming, petri-nets and virtual simulation, excluding simulation for physical design. according to this study, the first five techniques were the most commonly presented/used in the selected papers for that review. initially in our study, we also considered papers that reported on the use of intelligent simulation and parallel & distributed simulation. however, these categories were later dropped owing to the fact that only a few relevant papers pertaining to the aforementioned categories were found in our sample study (one or two for each category). moreover, our choice of simulation techniques is further supported by the study conducted by fone et al ( ) , wherein des, sd and mcs are discussed as popular simulation techniques in healthcare. those who wish to have an introduction to the aforementioned techniques can refer to rubinstein ( ) for mcs, robinson ( ) for des, and sterman ( ) for sd. abs is the most recent of the four simulation methods used since the mid- s. a brief description of abs is provided below. abs is a computational technique for modelling the actions and interactions of autonomous individuals (agents) in a network. the objective here is to assess the effects of these agents on the system as a whole (and 'not to' assess the effect of individual agents on the system). abs is particularly appealing for modelling scenarios in which the consequences on the collective level are not obvious even when the assumptions on the individual level are very simple. this is so because abs has the capability of generating complex properties emerging from the network of interactions among the agents, although the in-built rules of the individual agents' behaviour are quite simple. in this paper, we have conducted a review of literature in healthcare simulation. our review method has been influenced by the systematic literature review approach adopted by eddama and coast ( ) , wherein (a) databases such as isi web of science ® and medline ® were searched using a combination of search terms, (b) papers were screened by reading article titles and abstracts and in accordance to some inclusion criteria, and (c) the contents of the papers selected in the earlier stage were reviewed. our literature profiling methodology consists of two stages and is illustrated in figure . stage is the 'paper selection' stage and it describes the methodology used for the purpose of selecting papers for inclusion in this study. stage is the 'information capturing' stage and it identifies the information that is captured from papers that have been included in the study; the latter is analysed in the subsequent sections of this paper. both the stages of our methodology are further described below. the papers selected for this study were identified from the web of science ® database the web of science ® is one of the largest databases of quality academic journals and provides access to bibliographic information pertaining to research articles published from onwards. it indexes approximately high impact research journals from all around the world spread across approximately different disciplines. our aim was to identify publications with the highest credibility and thus we looked only at journal articles having an impact factor (note: only journals with an impact factor are included in the isi web of science ® database).we do recognise, however, that other bibliographic databases could have also been looked at. but for the purpose of this research, we decided to include only the web of science ® database since this study is not a systematic review but is a sample review of publications in healthcare simulation. the web of science ® has a user-friendly search engine that assists in the refinement of a search by allowing the user to incorporate specific search conditions. our search strategy was driven by the simulation methodology used in the sought after papers. to identify articles that would be incorporated in our study's data set, the following criteria were used: inclusion of the words, 'simulat*' or 'health*' in the article's title and both of the words/phrases ('monte same carlo' and 'health*') or ('discrete same event*' and 'health*') or ('system* same dynamics' and 'health*') or ('agent same based' and 'health*') in the abstract or keywords of the published paper. the same operator returns records in which the terms separated by the operator appear in the same sentence. the use of the asterisk, '*' in the boolean keywords combination, allowed for the inclusion of keyword derivatives in the search options. the search identified only articles and review papers written in the english language the second step involved the screening of these papers. the two authors independently and critically reviewed all the abstracts of papers' and read the full text when necessary. the appraisal was carried out based on certain inclusion criteria as follows: the selected papers should evidently demonstrate strong relation with the healthcare sector or have an impact on healthcare and use the chosen simulation method to describe, analyse or assess the situation. the paper should include at least one paragraph describing the applied simulation method that was used in the study. thus, pure physics simulations and human systems simulations did not fulfil the inclusion criteria. the boundaries between healthrelated papers and non-health-related papers, were not always straightforward. in many papers the impact on human healthcare is provided by a less direct relationship. the reviewers took a flexible approach by including papers in which one could clearly relate the problem described with some kind of health impact. each of the reviewers assessed all abstracts independently and compared the results were compared. in cases of discrepancies, the full text of the paper was examined and, after discussion between the reviewers, a decision was reached for the paper's inclusion or exclusion. this filtering resulted in a set of relevant papers. the full text papers were collected via online or inter-library loan services. the second stage concentrated on the content of the papers in order to answer the six objectives of our study as identified in the introductory section. of the selected papers, mcs seems by far to be ( %) the most applied method dealing with health issues. it is followed by des and sd. finally, the method with the least number of papers is abs-this is not a surprise since it is the most recently developed simulation technique. table (last two columns) lists the results of our screening. the last row of the table ('multiple simulation methods') identifies five papers that use or mention two or more simulation techniques. these ('multiple simulation methods') papers, for simplicity purposes, are described under the research paradigms of the four identified categories as explained in the next section. as this is a sample review, no inferences can be drawn from table as to the impact of each simulation method in healthcare. nonetheless, we believe that the statistics below provide the readers with some understanding of the research trends in this area. the papers that have been included in our review are listed in separate tables [tables - ] . these tables are presented in the relevant sub-sections associated with each simulation technique in question. every paper has a unique identifier beginning with the initials of the simulation method under which it is categorised (mc, des, sd, abs) and is suffixed with a numerical value, for example mc , mc , etc. when many papers are listed in a row under the same category, the prefix is entered only at the beginning and is omitted from the rest of the papers for brevity (eg mc , , ). in the tables, these papers are presented in a descending date of publication order, and this, in turn, shows the research effort over these years. thus, small numbers correspond to the most recent publications and large numbers to the older ones. the vancouver reference style is followed. rather than including the references alphabetically at the end of the paper, we consider this scheme of collecting and tabulating all references pertaining to a particular simulation technique together at the end of each section as important because we feel that it improves the readability of the paper. these tables will also serve as a future reference/study list for the reader. the papers pertaining to the different simulation techniques have been categorised under several general headings/categories. an overview of these categories is presented in table (objective ). this is followed by a discussion of the categories under each of the four identified simulation techniques (objective ). some papers can be categorised under multiple headings and the decision to favour one classification category over the other was based on the relative importance attributed to specific simulation techniques in the discussion part of the paper. mcs is the most predominantly used simulation technique of the four identified techniques. of the reviewed papers in mcs, we found to be suitable for inclusion in our dataset (table ). in the context of healthcare, mcs has generally been used for the following purposes: (a) to assess health risks from exposure to certain elements and determine drug doseresponse portions; this is the most popular sub-category with papers in our sample; (b) as the main approach to modelling used in economic evaluations in healthcare interventions when there is a need to increase the number of states in the model to overcome the homogeneity assumptions inherent in markov models and decision trees (barton et al, ) ( papers); (c) to evaluate the cost-effectiveness of competing technologies or healthcare strategies that require the description of patient pathways over extended time horizons with papers in this sub-category; and (d) for miscellaneous taxonomies, literature review and feasibility studies with papers altogether. each of these four issues will now be looked at in greater depth. health risk assessment numerous environmental and occupational studies have shown a link between the measures of public health and intake of contaminants, via different environmental media and exposure routes such as inhalation, skin and ingestion. twenty-two studies focused on air pollution [mc , , , , , , in such health risk assessments or epidemiological studies, the exact amount of a chemical or contaminant that an individual comes into contact with over a lifetime should ideally be estimated. however, for many obvious reasons this estimation is difficult. simulation studies can fill in data gaps regarding historical exposures by generating these data using parametric functions, which are critical to improving the power of such studies. mcs is the method most commonly used for classical probabilistic risk assessments that uses mathematical or statistical models to estimate the frequency in which an event will occur. this technique is particularly useful when a large number of algorithms are required to address various multipathways of exposure to humans. the use of monte carlo analysis has reformed the practice of exposure assessment and has greatly enhanced the quality of the risk characterisation. moreover, risk assessment studies focus on drug development and dose-response portion [mc , , , , , , , , , , , , , , ] . mcs can be used to determine the probability of target attainment of pharmacodynamic indices by taking the inherent variation of different populations into account. in mcs, the model parameters are treated as stochastic or random variables, by using a probability density function for example, rather than fixed values. the aim of these studies is to establish a population pharmacokinetic model to study the parameters for the drug being administered through an intravenous escalating dosing regimen in healthy subjects, which could, in turn, be used for design of patient protocols with direct therapeutic benefit and maximal safety. these simulations are dependent on the assumptions in the model, including the types and number of subjects in the pharmacokinetic studies and the data used. differences in pharmacokinetic parameters (for different patient populations) and/or data can lead to differences in the target attainment rates obtained with these simulations. studies of these kinds usually derive their data from clinical trials. prognostic and transmission models of health interventions mcs is extensively used to measure the number and impact of medical interventions for the prevention of disease deterioration or disease transmission. many intervention procedures with medical treatment show substantial reductions in disease morbidity or mortality. however, their use is expensive and to some extent determined by local practice, with great variation in the rates of these procedures. the optimum level of such procedures may therefore be uncertain, and this uncertainty is a major problem for both clinicians and health service administrators. it is therefore important to have methods that model the requirements for these interventions at the population level by capturing the movement of individuals between different states based on disease and/or procedure history. such interventions that usually involve patients or disease transmission stages use markov processes to measure the probabilities of transmission. mcs analysis of the markov process is the most useful model for this situation, which also allows the enumeration of events as the above research can easily be adapted or expanded to fit economic data, which evaluate the cost-effectiveness of specific interventions, treatments, tests and health programmes. certain medical conditions have a profound and growing impact on healthcare resource utilisation. in many circumstances the direct expenditures for screening or treatment (with drugs or other therapy) of these conditions have substantially increased due to the overall ageing of the population. therefore, research in this field tries to assess the economic value of a population-based screen-and-treat strategy for diseases or medical conditions compared to alternative strategies or no intervention [mc , , , this is the second most popular category in our study with papers overall after screening (table ). it is said that des can create significantly more insight than mcs in areas such as health economics . and work flow, allocation of resources when sizing and planning beds, rooms, and staff personnel) also bear resemblance to our sub-categories in 'planning healthcare services', as the latter study is focused on a specific area of des and is more analytic. we now discuss each of our des categories according to the number of publications identified in each cluster in a descending order. planning of healthcare services and health interventions des allows decision makers to effectively assess the efficiency of existing healthcare delivery systems such as hospitals [des ], to improve system performance or design and to plan new ones in a risk-free and costless environment by investigating the complex relationships among the different model variables (ie rate of arrivals, time spent in the system, etc) and overcoming bottlenecks. the scope of evaluation can be micro in scale, for example by examining resource needs in terms of scheduling staff and measuring bed and equipment capacity at individual clinics, or macro in proportion (healthcare policy for the entire population). des allows the decision makers to gather insights and obtain approximate results of the differing but competing policies that may be implemented in the future. moreover, since des allows the creation of dynamic population-based models, wherein each entity in the simulation represents an individual, the results could indicate the number of people who may be affected by the adoption of a particular strategy. some as large majorities of the population depend on edible products or by-products from livestock, the health of livestock has a significant effect on public health. health economic models health economic models evaluate the health implications and the economic costs of providing healthcare to the population at large. they usually do so by comparing alternative healthcare interventions aiming to maximise welfare through optimal utilisation of the allocated public health funds. with respect to health economic models, the use of des has been reported for evaluating, among others, the cost of providing dental care to children system dynamics sd can assist the design of healthcare policies by examining how the fundamental structure might influence the progressive behaviour of a system. it takes into consideration factors such as the time variation of both the tangible elements, such as waiting times and healthcare costs, as well as intangible elements, such as patient anxiety and the effects of various pressures on purchasing decisions (taylor and lane, ) . seventeen studies are counted under this technique. the papers pertaining to sd have been categorised under the following headings: (a) public health policy evaluation and economic models, represented in nine papers in our search; (b) modelling healthcare systems and infrastructure disruption (four papers); (c) use of sd as a training tool (three papers); and (d) one review paper of sd for modelling public health matters of disease epidemiology and healthcare capacity [sd ]. the first three categories are described below in the same order as above. the papers are listed in table . public health policy evaluation and economic models sd has been applied for the evaluation of several public health policies. with regard to communicable diseases, sd models were developed to estimate the effect of harm reduction policies for hiv/aids and tuberculosis (such as 'needle-sharing and injection-frequency among drug users and multi-drug resistant tuberculosis control [sd ]) and to assess economic consequences of testing and treating pregnant women for hiv virus with different regimens to avoid prenatal transmission [sd ]. moreover, sd was used in several studies to evaluate the long-term health impact of smoking by comparing policies such as increasing cigarette excise taxes, raising the legal smoking age to [sd ] and introducing tobacco harm reduction policies [sd , , ] . they suggested that a large tax increase would have the largest and most immediate effect on smoking prevalence. control over the cigarette content would bring a net gain in population health, although 'healthier' cigarettes make smoking more attractive and increase tobacco consumption. sd has also been used by health planners to gain a better understanding of diabetes population dynamics [sd ]; to model the feedback effects of reconfiguring health services [sd ] by shifting towards the primary level and bringing services 'closer to home'; to investigate the impact of privacy legislation in the individual health insurance market and the social costs that are borne when applicants do not divulge private information about their medical conditions [sd ]. modelling healthcare systems and infrastructure disruptions a healthcare system consists of many individual sub-parts that interact with each other, for example the national health system (nhs) consists of vast numbers of gp clinics, walkin centres, hospitals, tertiary care centres, a&e, it infrastructure, nhs supply chains, etc. sd allows modelling of several sub-parts of these complex healthcare systems, such as a city's delivery of emergency and on-demand, unscheduled care [sd ], an a&e dynamics of demand pattern, resource deployment and parallel hospital processes [sd ]. in this regard, sd also has the potential to simulate multiple, independent key elements of an infrastructure. innovative modelling and analysis framework based on sd could study the entire system of physical and economic infrastructures, and specifically of healthcare facilities, and propose public responses to infrastructure disruptions [sd ] and disasters [sd ], as well as to reduce the devastating health effects of such phenomena by modelling into a unified whole the relief effort of evacuations, provision of temporary shelters, restoration of electricity and communication lines, etc. training sd has also been used as a tool for training health policymakers. it can facilitate the understanding of the dynamics of an epidemic such as sars [sd ] and explore the applicable combinations of prevention or suppression strategies. moreover, sd provides an opportunity in some educational environments such as in health sciences by allowing students to experiment in the classroom with the use of professional tools. sd software together with calculator-simulators has been used for teaching pharmacokinetics [sd ], and pharmacological system dynamics models have also been developed for the same purpose [sd ]. applications of abs in the healthcare sector are not yet widespread but it has been used to study problems such as the spread of epidemics (bagni et al, ) . the research methodology that we have followed in our review has identified only two papers that have used abs. the papers are listed in table . one study reported an abs model called cancersim, which allows researchers to study the dynamics and interactions of cancer hallmarks and possible therapies [abs ] . the other study [abs ] used software agents to preserve individual health data confidentiality in micro-scale geographical analyses and showed that by limiting the accuracy of geocodes for the purposes of privacy protection, the ability to identify areas of high disease risk is degraded. the five papers that report on several simulation techniques (refer to table ) have been included in the mcs and the des category for the sake of simplicity. three papers report both on mcs and des and were described under the 'prognostic and transmission models of health interventions' [mc , ] and the 'cost-benefit analysis and policy evaluation of medical treatment and disease management programs' [mc ] headings of mcs. moreover, there are two papers that were described under the 'review papers' heading of des. a review paper [des ] that refers simultaneously to des, sd and mcs and a taxonomy paper [des ] that refers to des and sd among other operational research techniques. in this section, we present the citation statistics of a few highly cited papers in the field of healthcare simulation (objective ) ( table ). the table shows the total citations and the average article citations as a means of identifying the impact of these publications. the list is sorted (and therefore publications for inclusion in table are selected) based on the total citation count. however, the authors recognise that the average citation is also a very useful measure as it eliminates the discrepancies caused by the number of years passed since publication. it is generally expected that review papers have more citations than research papers. it is therefore surprising that none of the papers included in the list are review papers. even more surprising is the fact that all papers use the mcs technique as their main method table publications with high number of citations average citations publication of analysis. many of the papers in table present costeffectiveness analyses of specific healthcare applications or disease prevention methods, including the first paper that was published in the journal bone in . it should be noted here that a good number of journals in table are either medical or health-related journals. it is widely accepted that medical journals generally have citations that are much higher compared to the or journals, from which it might be concluded that impact is not incomparable between them. a more stratified representation would shed more light. however, this was out of the main scope of this study. in this section, we examine the evidence of results presentation, implementation (objective ), funding (objective ) and software usage (objective ) from among those papers that were selected for inclusion in this study after screening. of the papers, ( %) present results and have a separate, typically large section supported with tables and graphs to give a full analysis and explanation to the readers. there are seven mcs papers, eight des, three sds and one abs paper, which do not present results. of these, the majority are review and methodology papers. there are only five papers that fall in other categories (health risk assessment; health economic model; planning of healthcare services) and do not demonstrate results in a numerical format in the way described above. yet, implementation of research results is hardly mentioned in these publications, with only a few papers ( out of , . %) reporting on the implementation of results to the stakeholder organisations, in which the case studies were based. six are reported in the mcs category, four in des and one in sd. however, this is not to say that the case-oriented simulation studies that have not implemented their results have gone astray. neither should it be implied that their impact is only academic and does not reflect the real world. looking further at the issue, one may realise that healthcare simulation studies generally have a long gestation period before they reach the ultimate decision makers in a comprehensive format. these decision makers need to decide among a plethora of similar studies, taking into consideration various other factors, and come to a conclusion of turning a specific recommendation from a study into a policy applicable in health organisations and settings. subsequently, it is unlikely that implementation will be part of the paper. moreover, researchers are eager to publish once they have the first results in hand and only very occasionally will they wait until the impact of their method is shown in the real world in order to incorporate it into their paper. perhaps a better measure of the interest in the research being conducted in the healthcare simulation studies is the funding process. of the studies, ( %) have received full or partial funding. of the identified mcs studies, around % mention their project's funding source, % of the des papers, % of the sd papers and % of the abs papers (two papers) report a funding source. many of these papers refer to various sources of funding. table illustrates some of these sources. as can be seen from the table, health departments and national foundations are the major sources of funding, closely followed by pharmaceutical companies. other governmental departments and national institutions also fund healthcare studies. funds for research are also derived from internal university funding and research council grants. from our sampled list of papers, we find that funding seems to be consistent throughout the years. this suggests that there is no identified trend that more funding is provided for healthcare research over the last years or vice versa. finally, we conclude by presenting some statistics on simulation software/programming languages that were used to support model development in the selected studies. it is important to mention that, from our sample of selected papers, only papers acknowledge the software or programming language that was used to develop the model. this data is presented in table (mcs software), table (des software) and table (sd software), respectively. with regard to mcs (table ), @risk and crystal ball were among the most popular software, followed by excel. numerous other software and programs have also been used, some of them specific to health or other applications. the process of building des models involves some form of software. the software can either be a high-level programming language or a commercial, off-the-shelf (cots) simulation package. des software arena is the most popular in this sample review, followed by the programming language borland delphi and cots package simul (table ) . as for sd, the use of only few types of software is reported. vensim is first in the list, closely followed by stella. dynamo comes last (table ) . finally, one of the two abs papers reported the use of the programming language c++ to create cancersim. in general, the rapid growth in simulation software technology has created numerous new application opportunities, including more sophisticated implementations, as well as combining simulation and other methods for complex models and processes. trends from our data analysis suggest that, in the most recent years, cots packages have taken the lead over one-off models that are coded using programming languages. this is explained by the fact that cots simulation packages are rapidly evolving through inclusion of more advanced features (eg -d graphics, parallel processor support, etc). the field of healthcare simulation has evolved significantly over the past years. a great number of health problems have been approached with simulation techniques, which have offered greater precision with regard to resource allocations, evaluations between health strategies and risk assessments. in this review paper reflecting on years of healthcare simulation, we see some trends that apply to the discipline as a whole. looking first at the statistics of our sampled papers, we could derive the conclusion that the proportion of papers published in the field has drastically increased, with more than three-quarters published after . annual paper contributions amounted from one paper in to in . it is, however, surprising that the oldest paper in our data set is from as our search strategy concentrated on identifying healthcare simulation papers published from onwards. one reason for this is possibly that the number of journals indexed by isi wos has swelled with the rising popularity of the internet and the availability of electronic bibliographical information (this may not have been the case during s- s). furthermore, it is arguable that although simulation has been applied to manufacturing, defence, supply chains etc., for a long time, its application in the healthcare context is comparatively new. figure illustrates the historical trends of the healthcare modelling papers for each simulation technique (the only exception is abs which has only two papers). the ascending lines show the increasing number of published papers in the field especially after the mid- s for all three simulation methods. this is in line with the clear increase in simulation usage in the general service sector from the s onwards (robinson, ) . year-to-date figures suggest that this gradual upward trend will continue. it is apparent that during the last years the published papers in this field have drastically increased. a reason might be the possible increase of funding in recent years (murphy and topel, ) . simulation as a technique in health problems is used both as the main methodology of the research and as a supportive method to evaluate the robustness of other methods in different papers. mcs seems to be the most popular simulation technique in health studies, and the majority of papers fall within the health risk assessment category. in this category studies pertaining to air and water pollution, food poisoning and soil contamination are leading in terms of published papers, and drug development and dose-response portion studies follow. cost-benefit analyses health studies with the use of mcs are also popular. they assess the economic value of population-based screen-and-treat alternative strategies for diseases and medical conditions. some of these studies hold the first positions in terms of research impact and are found to have the maximum average number of citations in our dataset. moreover, it is particularly noticeable that of the mcs papers, none were published in an or journal (as defined by the association of business school-abs list). one reason for this may be that mcs is extensively used by health professionals/academics who wish to publish in health-related outlets, or that or academics have lost interest in the use of mcs and have focused in the use of other simulation techniques to tackle health problems. nevertheless, several of the mcs papers identified in our study would fit the aim and scope of or journals. for example mc , , , , , , , , , and many more. in the analysis of the research paradigms categories, it is obvious that some overlap exists among the health applications examined by simulation technique. a very apparent example is that all simulation techniques deal with screening strategies and cost-benefit analysis of medical interventions. assuming that the categorisation of papers was made according to the health problem tackled and regardless of the simulation technique employed, the papers of cost-benefit analysis would be at about the same level of the health risk assessment category. however, many researchers will agree that, although the application area is the same, the extent, the level and the detail at which this is examined differs according to the technique employed. sd takes a holistic approach and thus the health problem or situation is looked at from a more global level to a greater extent. consequently, this technique is appropriate for facilitating health policy making at the macro-level. des and abs examine the health problems in more detail (micro-level), taking into account the properties of individual entities, yet this restricts the extent of the system that can be modelled. therefore, decisions can usually be reached with the use of des and abs only at the operational level. monte carlo simulation incorporates the random sampling element at aggregated level, which makes modelling of population-based diseases easy to handle. when the individual aspect is important then des is more appropriate. moreover, des and sd are more suitable for modelling problems in which the time element plays a significant role, such as utilisation of health services' resources and bed/equipment capacity management. nonetheless, looking at the categories presented in this study, one can see that health risk assessment is pertinent to mcs modelling; planning of health services is most of the times handled with the des models (and less with sd); and training of health students and managers is prevalent in the sd approach. unfortunately, we could not make a distinct category for abs since the sample was so small. moreover, a year-by-year analysis of the number of papers in each research paradigm showed that there are no chroni gaps in the identified categories, and for that reason published research in these general fields are continuous. relatively few of the published healthcare simulation articles reported significant effects that simulation had on the healthcare system being studied. this may imply that, although authors document the model, the issues they model and the model results, there are few real implementation results to report. england and roberts ( ) implied that the reasons behind this are either inadequate models that cannot quantify the impact of the human factor, or the diversity of authority in healthcare facilities, which thwarts the simplicity of a single administrative decision to change the system. the latter problem lies mostly in the political sphere. however, governmental bodies and other national or local council/agency fund a considerable number of studies ( % in our review). in terms of the modelling approach, it seems that the use of cots packages is quite widespread, although many models are still being developed in high-level programming languages that usually have larger capabilities in accommodating complex behaviours of the system modelled. yet, the ease of use that is offered by cots simulation packages allows those who are not computer programmers to develop valid simulation models. this gives the opportunity to a number of people, including some stakeholders of the systems under question to engage in modelling and quantify their problems and the impact of alternative actions. however, in this way, limitations to the models are posed not only by the data availability and the computer operating cost but also by the imagination and capabilities of the modeller and the software. simulation software costs can be high, yet since the mid- s, a number of low cost cots packages have come to the market. the latter have certainly widened access to simulation (robinson, ) . it is widely accepted that one of the most important results of computer simulation in healthcare, as well as in other sectors, is the increased understanding of the systems being modelled, which results from constructing the models. we hope that in the future it will become more imperative that healthcare modellers seek close ties and cooperation with healthcare administrators to ensure utilisation and implementation of the worthwhile models that are developed. however, the exact same anticipation was expressed some years ago (england and roberts, ) . as stated by robinson ( ) , simulation techniques have all followed separate paths in both research and practice until now. a closer integration among simulation techniques conjoined with advances in computing and inclusion of the world wide web could lead to the development of better designed models with faster execution times, high level of graphics and, most importantly, enhanced user interaction. such an advance will be in line with the requirements of the new computer literate generation of users. this is a sample review of healthcare simulation studies, which aims at identifying healthcare problems that are modelled using four popular simulation techniques, namely mcs, des, sd and abs. the specific selection criteria of articles that were reviewed here may have left out a number of noble publications in the field (eg articles that do not mention health in their title topic but refer to health problems with more specific terms such as hospitals, patients, etc; articles that did not appear in journals indexed by isi web of knowledge ® ). the implications of this are that there may be an unintentional bias introduced by the specific keywords search and by isi wos membership, which leaves out newer journals that have not yet met the 'duration of service' required by the isi wos and journals where editorial boards do not wish their journal to have an impact factor. these factors may therefore not be taken into account when basing quality on impact factors. however, the debate as to whether this is right or wrong is outside the scope of this article. we merely wish to provide an analysis of literature within the scope of journals with impact factors and therefore provide some reflection as to the 'health' of healthcare simulation within a potentially metric-driven world. we hope that this study gives an indication of the pulse of research being conducted in the healthcare simulation field, although generalisation of the results may not hold. future research could involve a systematic review of the field including all relevant journals from various academic databases and investigate the relationships between impact factor and non-impact factor journals. this approach could more accurately map the discipline and provide us with statistics of interesting variables similar to the ones presented here and with additional ones, such as popular journals, productive institutions and frequently published authors. future research could also broaden the scope of our literature review by profiling health-related research with the use of other or/ms techniques. for the benefit of healthcare and simulation audience, this paper provides an overview of research published in various journals from across different subject areas in health. this research is likely to help authors, reviewers and editors to better understand the potential of different simulation techniques for solving diverse healthcare problems and can also assist upcoming researchers in developing an appreciation of this research area and the various issues considered worthy of research and publication. furthermore, we hope that healthcare planners, management engineers, as well as researchers will benefit from this study, by having ready access to an up-to-date, indicative collection of articles describing these applications. finally, our study is likely to stimulate researchers to explore other research areas by undertaking comparative/cross-journal studies. monte carlo simulation of animal-product violations incurred by air passengers at an international airport in taiwan a sas/iml program for simulating pharmacokinetic data a clinically based discrete-event simulation of end-stage liver disease and the organ allocation process an analysis of data from two general health surveys found that increased incidence and duration contributed to elevated prevalence of major depression in persons with chronic medical conditions using simulationto assess the sensitivity and specificity of a signal detection tool for multidimensional public health surveillance data pharmacoeconomic assessment of oseltamivir in treating influenza-the case of otherwise healthy danish adolescents and adults human health risk assessment of naturally occurring radioactive materials in produced water-a case study treatment costs in canada of health conditions resulting from chronic hepatitis b infection advances in risk-benefit evaluation using probabilistic simulation methods: an application to the prophylaxis of deep vein thrombosis health economics studies assessing irbesartan use in patients with hypertension, type diabetes, and microalbuminuria estimating the demand for health care with panel data: a semiparametric bayesian approach. health econ improved radial dose function estimation using current version mcnp monte-carlo simulation: model and isc ( )i brachytherapy sources health system costs of out-of-hospital cardiac arrest in relation to time to shock incorporation of statistical uncertainty in health economic modelling studies using second-order monte carlo simulations assessing cost-effectiveness-mental health: introduction to the study and methods population pharmacokinetics of apomine (tm): a meta-analysis in cancer patients and healthy males cardiovascular health and economic effects of smoke-free workplaces costs and net health effects of contraceptive methods predictive assessment of fish health and fish kills in the neuse river estuary using elicited expert judgment parametric analysis of intercellular ice propagation during cryosurgery, simulated using monte carlo techniques a quantitative risk assessment of waterborne cryptosporidiosis in france using second-order monte carlo simulation quantifying human health risks from virginiamycin used inchickens how robust are health plan quality indicators to data loss? a monte carlo simulation study of pediatric asthma treatment an environmental decision-making tool for evaluating ground-level ozone-related health effects use of monte carlo simulation to design an optimized pharmacodynamic dosing strategy for meropenem public health, gis, and spatial analytic tools cost-effectiveness of recombinant versus urinary folliclestimulating hormone in assisted reproduction techniques in the spanish public health care system cost benefit of influenza vaccination in healthy, working adults: an economic analysis based on the results of a clinical trial of trivalent live attenuated influenza virus vaccine bayesian analysis of a self-selection model with multiple outcomes using simulation-based estimation: an application to the demand for healthcare a simulation model for estimating direct costs of type diabetes prevention design techniques for stated preference methods in health economics oseltarnivir for treatment of influenza in healthy adults: pooled trial evidence and cost-effectiveness model for canada clinical trial simulation using therapeutic effect modelling: application to ivabradine efficacy in patients with angina pectoris breaking out of the silo: one health system's experience. american journal of health-system pharmacy in silico toxicology: simulating interaction thresholds for human exposure to mixtures of trichloroethylene, tetrachloroethylene, and , , -trichloroethane. environ. health perspect using monte carlo simulation in life cycle assessment for electric and internal combustion vehicles cost effectiveness of influenza vaccination for healthy persons between ages and years chloroform associated health risk assessment using bootstrapping: a case study for limited drinking water samples a monte carlo simulation for modelling outcomes of aids treatment regimens health risk assessment on residents exposed to chlorinated hydrocarbons contaminated in groundwater of a hazardous waste site simulated effect of tobacco tax variation on latino health in california monte carlo simulation of nitrogen oxides dispersion from a vehicular exhaust plume and its sensitivity studies simulation and assessment of subsurface contamination caused by spill and leakage of petroleum products-a multiphase, multicomponent modelling approach health and economic consequences of hcv lookback an event-by-event probabilistic methodology for assessing the health risks of persistent chemicals in fish: a case study at the palos verdes shelf cost-benefit analysis of a strategy to vaccinate healthy working adults against influenza penetration of particles into buildings and associated physical factors. part i: model development and computer simulations a probabilistic model for silver bioaccumulation in aquatic systems and assessment of human health risks life expectancy as a summary of mortality in a population: statistical considerations and suitability for use by health authorities the use of the tobit model for analyzing measures of health status the use of monte carlo simulation to examine pharmacodynamic variance of drugs: fluoroquinolone pharmacodynamics against streptococcus pneumoniae a case study of stochastic optimization in health policy: problem formulation and preliminary results a model of the health and economic impact of posttransfusion hepatitis c: application to cost-effectiveness analysis of further expansion of hcv screening protocols cost effectiveness of human immunodeficiency virus postexposure prophylaxis for healthcare workers a monte carlo simulation study to investigate the potential of diffraction enhanced breast imaging a stochastic model simulating the feeding-health-production complex in a dairy herd analytic approaches based on life expectancy and suitable for small area comparisons quasi-reml' correlation estimates between production and health traits in the presence of selection and confounding: a simulation study health risk assessment of a modern municipal waste incinerator public health sealant delivery programs: optimal delivery and the cost of practice acts modelling and improving emergency department systems using discrete event simulation. simulation-transactions of the society for modelling and simulation international modelling the economic and health consequences of managing chronic osteoarthritis pain with opioids in germany: comparison of extended-release oxycodone and oros hydromorphone emerging methods in economic modelling of imaging costs and outcomes: a short report on discrete event simulation choice of modelling technique for evaluating health care interventions a simulation study of scheduling clinic appointments in surgical care: individual surgeon versus pooled lists using simulation to improve the blood supply chain combining data mining and discrete event simulation for a value-added view of a hospital emergency department simulation modelling in healthcare: reviewing legacies and investigating futures a taxonomy of model structures for economic evaluation of health technologies. health econ montgomery countys public health service uses operations research to plan emergency mass dispensing and vaccination clinics. interfaces forty years of discrete-event simulation-a personal reflection modelling the economic and health consequences of cardiac resynchronization therapy in the uk modelling the health benefits and economic implications of implanting dual-chamber vs. singlechamber ventricular pacemakers in the uk modelling the treated course of schizophrenia: development of a discrete event simulation model cervical screening programmes: canautomation help? evidence from systematic reviews, an economic analysis and a simulation modelling exercise applied to the uk a clinically based discrete-event simulation of end-stage liver disease and the organ allocation process planning health services with explicit geographical considerations: a stochastic location-allocation approach use of discrete-event simulation to evaluate strategies for the prevention 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fractional polynomials to model continuous risk variables in epidemiology capacity management in health care services: review and future research directions system dynamics modelling simulation applied to health services: opportunities for applying the system dynamics approach the convergence of health care expenditure in the us states modelling as a way of organising knowledge acknowledgements-one of the authors was employed as a research fellow in warwick business school while working on this paper, and wishes to thank the school for supporting this research. we also thank dr simon j. e. taylor for his comments, which have improved the paper. key: cord- -upjhmfca authors: tshilenge mfumu, jean-claude; mercier, annabelle; occello, michel; verdier, christine title: a multiagent-based model for epidemic disease monitoring in dr congo date: - - journal: biomedical engineering systems and technologies doi: . / - - - - _ sha: doc_id: cord_uid: upjhmfca any infectious diseases have been reported in sub-saharan countries over the past decade due to the inefficiency of health structures to anticipate outbreaks. in a poorly-infrastructure country such as the democratic republic of congo (drc), with inadequate health staff and laboratories, it is difficult to respond rapidly to an epidemic, especially in rural areas. as the drc’s health system has three levels (peripheral, regional and national), from the production of health data at the peripheral level to the national level that makes the decision, meantime the disease can spread to many people. lack of communication between health centres of the same health zone and health zones of the same health provincial division does not contribute to the regional response. this article, an extended version of [ ], proposes a well elaborated solution track to deal with this problem by using an agent-centric approach to study by simulation how to improve the process. a new experiment is described by arranging twenty-eight health zones of kinshasa to show how their collaboration can provide unique health data source for all stakeholders and help reducing disease propagation. it concerns also health centres, medical laboratory, provincial health division and rapid riposte teams. the simulation data, provided by provincial health division of kinshasa, concerned cholera outbreak from january to december . the interaction between these agents demonstrated that health zone agent can automatically alert his neighbours whenever he encountered a confirmed case of an outbreak. this action can reduce disease propagation as population will be provided with prevention measures. these interactions between agents have provided models to propose to the current system in order to find out the best that can help reducing decision time. introduction experiencing serious difficulties in improving the living conditions of its population, particularly in the field of basic health care. life expectancy at birth is and respectively for men and women [ ] . the country is currently divided into city-province of kinshasa and other provinces. the provinces are subdivided into territories which are divided into sectors. to facilitate the supervision of health structures, drc health system is divided into three levels [ ] : central, intermediate and peripheral. the nearest level to population is the peripheral area composed of health zones (hz) that coordinate the actions of health facilities. a health zone is divided into health area (ha) containing one or more health centers (hc) and a general referral hospital (grh). the central (national) level defines the policies, strategies and resources of the sector. it enforces strategies and policies at the peripheral level through the intermediate level called the provincial health division (phd), which coordinates primary health care and technical support activities for health zones in a province. provincial health minister (phm) is the political authority of the province. each health zone has a health information bureau (hib) which retrieves aggregated data from all its supervised health area to send to national level for decision measures. hib has a health zone executive team (hzet) that organizes weekly meetings to discuss about suspicious cases to report to hierarchy if needed. health zone executive team manages health facilities (hf) that includes health center and grh. as who member country, drc benefits from the technical and financial support of the partners to respond to epidemics under the conditions stipulated in the international health regulations (ihr) [ ] . all cases of these four diseases must be automatically notified to who: smallpox, poliomyelitis due to wild-type poliovirus, severe acute respiratory syndrome (sars) and cases of human influenza caused by a new subtype. on the ever-changing list of diseases provided by ihr, each country is free to add other diseases, with epidemic potential or not, which constitute a public health problem. access to basic care is difficult for a large part of population. people visit the health facilities in case of extreme emergency. this is more evident in rural areas where the diminishing resources of farmers do not allow them to consult medical services regularly. most of time health care is provided during free medical workers' campaigns. the most usual ways to collect data about cases that must be sent to the hierarchy for decision-making are described below [ ] : -pharmacies must report when same medicines are increasingly purchased by population or when they detect some recurrent treatments; -schools reporting unusual rates of pupil absences due to strange signs and symptoms; figure presents an exhaustive list of actors used in providing health data. despite great efforts to improve disease surveillance and response, drc faces big challenges in identifying, diagnosing and reporting infectious diseases properly due to the remoteness of communities, the inadequate transport and communication infrastructures, and the lack of qualified health staff and laboratory facilities to ensure accurate diagnosis. the challenge, in this paper, is to find new solutions based on real population life and situation to improve health services organization and data sharing in order to detect infectious disease very quickly, organize the response and prevent the spread of disease. in this paper, we present a part of this challenge. we propose a multi-agent system to simulate the interactions between actors working together to organize an optimal response to epidemic detection. when a new case of infectious disease is suspicious in health center, actors will collaborate to report it to provincial health division through health zone executive team. the approach will be based on the current drc heath system processes to extract relevant actors' tasks. the identification of these actors and their tasks will provide the opportunity to simulate a new system that distributes the entire competences of the old heath system to those actors in order to improve their collaboration and eventually shorten the making-decision time response. work-sharing protocols will be proposed to simplify the complexity of the data sources. this paper focuses precisely on improving the process of reporting health data from the peripheral level to the hierarchy for rapid decision-making and anticipate as much as possible the medical response using multi-agent systems (mas). hierarchical dependency between three levels forbids peripheral to directly transmit health data to national level for quick decision. as information must pass through intermediate level (provincial health division), with defective means of communications, it drastically hampers the fight against a propagation of a disease. since decision-making is pushed back to the central level, it can intervene belatedly at the risk of witnessing an alarming spread of an epidemic with high epidemic potential. the next section shows the related work in healthcare and multiagent domains. section describes the healthcare system and problematic in drc. the methodological approach and agent's models are explained in sect. . the model is validated by a simulation presented in sect. . future research directions and conclusion are developed in sect. . information and communication technology is a powerful solution for health care in developing countries [ ] . it made possible the improvement of remote patient follow-up [ ] , controlling the progression of malaria [ ] , improving the uptake of information from health systems [ ] . two main ways of research can be studied in this paper: the use of mobile phone as a relevant medium to rapidly transfer medical data and the multi-agent system that is powerful to simulate organizational skills to anticipate diseases spreading. mobile phone coverage in africa grew from % in , % in to more than % in [ ] . this technology is used to cover numeric fraction. to improve drug adherence and suppression of plasma hiv- rna load in kenyan, mobile phone communication between health-care workers and patients starting antiretroviral therapy was set up [ ] text-message reminders sent to health workers' mobile phones improved and maintained their adherence to treatment guidelines for outpatient pediatric malaria [ ] . phone traces are powerful tools to estimate population migration while investigating an outbreak. these techniques were used to demonstrate the feasibility of rapid estimates and to identify areas at potentially increased risk of outbreaks in haiti. they produced reports on sim card movements from a cholera outbreak area at its immediate onset and within h of receiving data. results suggest that estimates of population movements during disasters and outbreaks can be delivered rapidly and with potentially high validity in areas with high mobile phone. a trial of mobile phone text messaging for diabetes management in an eight-month period to transmit data such as blood glucose levels and body weight to a server that automatically answered with a monthly calculated glycosylated hemoglobin result. the trial results suggest that sms may provide a simple, fast and efficient adjunct to the management of diabetes. in developed countries sms messages have been widely used to remind patients of scheduled appointments car and all, ). similarly, more complex mobile phone applications have shown significant improvement in the follow-up of malaria patients in thailand. the same approaches have been tested in africa as part of the sms reminder package to improve patients' adherence to antimalarial treatment schedules in .six sub saharan countries [ ] . even if text-messaging is the simplest and the most widely easy to use technology function in reporting periodic data from the health system peripheral to control managers, it however needs to be experienced in interventions targeting individual patients, for whom a high facility workload or illiteracy may present a barrier. a multi-agent system is a set of agents situated in a common environment, which interact and try to reach a set of goals. through these interactions, a global behavior, more intelligent than the sum of the local intelligence of multiagent system components, can emerge. by 'agent' we mean a software entity evolving in an environment that it can perceive and within which it reacts. there are several kinds of agents. a reactive agent reacts to the stimuli of the environment. cognitive agents have a more developed intelligence: they manage knowledge and make decisions according to their internal states and according to their perception of the environment. it is provided with autonomous behaviors and some objectives. autonomy is the main concept in the agent issue: it is the ability of agents to control their actions and their internal states. the agents' autonomy implies no centralized control [ ] . when a mas integrates agents on the fly dynamically during the execution, the system is qualified as an opened one. otherwise, it is a closed one. one of the advantages of mas is to model systems where a global description is not possible at any given moment. multi-agent conception is well suitable to model actors described in fig. . simulation based on mas approach has wide potential applications in healthcare. first case, mas approaches are suitable to applications where a complete control is unreachable, the high number of entities or the complexity of entities' behavior make hard to represent the overall system. the second case is related to the monitoring of the epidemics. in a general way, the model of each agents going into action in the system is designed in microscopic level. the environment, the agents' interactions and the social organizations are defined at the macroscopic level. in mas domain, there are numerous methods to approach the analysis and the design of the software application. the methods come from various domains such as object oriented design, knowledge engineering or reproduction of behavior or natural phenomena. the first methods were aaii [ ] which uses an external view (roles services, organization) and internal view (agent design bases on belief desire intention architecture). cassiopée [ ] is a bottom-up approach based on natural behavior and desire [ ] is based on knowledge engineering. the method vowels [ ] allows obtaining modularity at the level of the multi-agents models by decomposing the problem into four elementary facets. other method like gaia [ ] extends the concepts used in classical object engineering and provides a microscopic and a macroscopic view of the software system. there are also complete approaches for developing multi-agents systems from the analysis to the deployment by using mase [ ] or prometheus [ ] . moreover some models al-low the designer to develop the agent like agr [ ] based on agent/group/role or bdi [ ] based on belief/desir/intention. the main concept of all those approaches is the agent and the communication between agents to lead to the main objective of the software. the general classification is clinical, operational, managerial and educational simulation. managerial and operational simulations are closely interrelated. both are the core components for healthcare process management. some challenges and trends of simulation models in healthcare in the past two decades have been developed the design of a web-based clinical decision support system that guides patients with low back pain in making suitable choices on self-referral has been experienced in netherlands. mas is used to describe an approach to the analysis and development of telemedicine systems [ ] , to manage communications in wireless sensor networks [ ] , the epidemiological decision support system [ ] , the care of seniors at home [ ] , decision-making for monitoring and prevention of epidemics [ ] , evaluation of disaster response system [ ] , medical sensor modules in conjunction with wireless communication technology supporting a wide range of services including mobile telemedicine, patient monitoring, emergency management and information sharing between patients and doctors or among the healthcare workers [ ] . mas can be considered as a suitable technology for the realization of applications providing healthcare and social services where the use of data and remote collaborations among users are often the most requirements [ ] . cooperation in agent technology can provide better healthcare than the traditional medical system [ ] . real programs built on the multiagent paradigm are still evolving towards a complete maturity. the variety and complexity of the e-health scenario make it one of the most interesting application fields, able to check the advantages of their use to condition their evolution [ ] . mas was used to monitor a generic medical contact center for chronic disease environment, detect important cases, and inform the healthcare and administrative personnel via alert messages, recommendations, and reports, prompting them to action [ ] . developed mas applications in healthcare can provide a reasonable way to mitigate the cost due to increased demand for services [ ] . an agent-based model (abm) with geospatial and medical details was used to evaluate the efficiency of disaster responders to rescue victims in a mass casualty incident situation in south korea [ ] . abm can cooperate to share tasks between sensors observing a phenomena [ ] , to manage diabetes treatment between caregivers and patients. the usability evaluation of a collaborative information system for dementia assessment built using a usercentered design approach was experienced in norway [ ] . but from several research papers we have reviewed we didn't find a paper addressing abm in sharing tasks from multisource health information to organize a rapid response to a high epidemic potential disease. the patient health care and the reporting of suspicious cases are managed at the peripheral level by health facilities (hf): health centers plus the general referral hospitals. health data collected by the health facilities are transmitted to health zone executive team for consolidation, analyzes and decision-making. aggregated data from entire health zone are also transmitted to provincial health division. each week this intermediate level structure convenes meetings to analyze data from each health zone, decide on actions to take. provincial health division produces consolidated data for its province. provincial health division must transmit the health data from its province to the central level for a second analysis and national consolidation. if suspicious cases reported by health zone require deeper investigation, laboratory tests or kits intervention, provincial health division will ask for technical and financial supports from central level. disease control direction (dcd) is a central respondent at central level. it also organizes weekly meetings to analyze health data from all provinces. it often provides advice and recommendations to provincial health division to monitor suspicious cases in accordance with the national policy of the sector. whenever provincial health division asks for a help, dcd can approach government authorities, special programs, partners and even the international community, to fill up needs. difficulties encountered by health facilities to better report information and structures dependency are well expressed at next section. the first challenge in managing epidemics begins with the multi-sources data processing at the health zone level. national policy has provided list of groups of individuals who can retrieve information from suspicious cases. this information transmitting by phone calls or narrative is not exhaustive. hence, the interest in diversifying the mode of communication by adding text and voice sms, tweets and phone calls on green lines can enhance data completeness. a second difficulty in an accurate identification of suspicious cases is the insufficient number of qualified health staff [ ] . despite training courses organized by health zone executive team for community relays and staff of health facilities, there are gaps in the implementation of the information brought to their attention. for example, the provincial health division can conduct a thorough investigation with qualified staff as soon as the number of suspicious cases reaches the threshold for the pathology. lack of information on the list of the nearest laboratories delays response time to confirm cases and ensure accuracy of diagnosis. hierarchical dependences do not favor communication between structures of the same level such as health areas of a same health zone or of contiguous health areas but belonging to different provincial health division. this lack of dialogue can lead to the non-detection of an epidemic for the simple reason that the number of suspicious cases to organize investigation is not reached in an health zone. however, by combining number of suspicious case found in contiguous health areas, we could detect the pathology at the intersection of the provinces. structures authorized to report information relating to suspicious cases to health zone executive team are health facilities. but, community relays can also report their observations that need to be considered by health facilities. reports concern pathologies described at international sanitary regulations (smallpox, poliomyelitis due to wild polio virus, human influenza and severe acute respiratory syndrome (sars)) and local list of diseases with epidemic eradication measures or elimination and other chronic diseases provided by authorities. as soon as it appears, suspicious cases must be transmitted to health zone executive team by all data providers indicated on fig. . when number of suspicious cases in health zone equals to the threshold of observed pathology, a rapid riposte team (rrt) has to investigate some health center and the population of the concerned health area to make sure the allegation was correct. the investigation of rapid ripost team could result to laboratory tests of some samples. in case of riposte many hierarchical structures such as provincial health division or national level would intervene to provide technical and financial supports. the process used to organize riposte simulation is heavily based upon computer science, mathematics, probability theory and statistics: yet the process of simulation modeling and experimentation remains very much an intuitive art. simulation is a very general and somewhat ill-defined subject. for the purpose of this paper, we will define simulation as «the process of designing a computerized model of a system and conducting experiments for the purpose of understanding the behavior of the system and/or of evaluating various strategies for the operation of the system. thus we will understand the process of simulation to include both the construction of the model and the analytical use of the model for studying a problem shortly described in fig. . health zone executive team analyze the report of surveillance to determine if the number of suspicious case has reached the threshold to order an investigation. rapid ripost team will research new cases at health area according to the clinical definition of case. it will find out new determinants of the outbreak to report to provincial health division in other to realize the response. a final evaluation of outbreak response presented as a report of the process can be shared with other health zone and health facilities. this type of system is well suited to mas using an aeio representation. real system is analyzed with four elements: agent, environment, organizations and interactions between agents. this model will be detailed in the next part. the hierarchical organization of the healthcare system in drc is a good candidate for a multiagent model because there are several kinds of agents with personal goals sharing the same global achievement. in the process described in fig. , the agents use some knowledge and tasks to perform a main goal together: collecting data in order to respond with efficiency to epidemic. at the stage of this research, the simulation's objective is to understand how the drc's healthcare system reacts in epidemic diseases. it is a preliminary work before (i) determining metrics to analyze process simulations and (ii) developing modules in embedded systems -phones or tablets-to assist the end-user in the data collection, coupled with the multiagent system. multiagent-based-simulation (mabs) allows explicitly modeling the behavior of each individual and viewing the emergent system from the interactions between the individuals. morvan in [ ] proposes a survey on mabs and presents several multiagents platforms. in these existing platforms, we have not found solutions which can act as both a simulation system and a tool to end-users on embedded systems. diamond method and its associated simulator mash -multiagent software hardware simulation -developed in lcis laboratory provided the capacity of testing a method in a tool of simulation [ , ] . diamond -decentralized iterative multiagent open network design -is a method that guides the designer from the requirements to the implementation. it is based on a-e-i-o decomposition for agent, environment, interactions and organization of the system. the agent dimension concerns the model of the reactive agent represented by a simple automaton, the cognitive agent manipulating information or a more complex agent based on a knowledge system. the environment is the context in which the agent reacts, its geographic location. the interaction dimension specifies the way the agents communicate; it mainly consists of protocols of interaction or the type of communication. the organization dimension reflects the structural relations between the agents (group, hierarchy, market). these four key concepts are considered under a global angle (the society) and a local one (agent view). the diamond method proposes an analysis phase of the problem in four steps: the situation phase helps to find the society's circumference to be represented by defining the limits of the system, agents and environment; the individual phase concerns the internal functioning of the agents (behavior and the knowledge); the social phase defines the relations between agents, particularly by integrating into its knowledge communication protocols and information structures to understand the society organization and -the phase of socialization consists of integrating the individual agents into the society by adding the social influences into its behavior (possible answers in the requests from the outside, the launch of interaction protocols and the choice to be made according to its position in the organization). we decide to use this method because it allows explicitly designing the behavior of each individual. however, coupled with the mash simulator platform, it is useful to view the emergent system from the interactions between the individuals. the process in fig. can be modelized by agents able to be simulated in the mash simulator. the mash simulation platform was used to simulate systems with embedded and software agents. it is suitable to our problem because we plan to provide a tool for collecting data with phones or tablets applications. to have an individual-centered vision of the process is one of the advantages of this simulation. afterwards, we will be able to contribute to the improvement of the process with an exterior view by proposing changes and ideas to reduce the response time for example. this section shows the steps to break down multiagent system's elements. to start the analysis, each individual agent's behavior is studied. it is a way of seeing things at a micro level. the phenomenon at macro level does not change and the process remains the same even if observer's level changes. the objective is to be able to adjust the behavior of each individual agent and probably to add some skills to certain nodes or node types. the first step of this approach is to find out what to model as agents from information of the process. in our study context, agents are: health centers, general referral hospital, health areas, provincial health division, any national health entity related to the administrative structures, health zone executive team and rapid ripost team for human team working group. figure shows for instance the internal behavior of one agent (rapid ripost team). for each agent, we have to list all its skills, what information will be required to store or to handle and how agent acquires this information. this information should be acquired directly by perception (e.g. the user grasps something) or on demand by asking other nodes (higher hierarchy or same level nodes). in this step, we obtain for each agent a vision of the relevant knowledge to perform its individual tasks. that information is required by agents working in the same environment. the result is a set of tasks that an agent can perform. these tasks correspond to the skills of each node. some skills are executed by one agent without the need of other agents. but to achieve a goal, an agent should have partial information and should ask to other agents to complete their goal. however, this will result to a cooperative behavior in place of an individual one which is entirely internal to agent. this kind of social behavior reflects an interaction between several agents: either to gain information or to share tasks. social behavior. in this second step, we will have to create interactions between nodes for example to back up information (health center to health zone executive team) or to receive orders (health zone executive team from provincial health division). these interactions should intervene between different partner groups such as health areas. in the implementation, we define very simple interaction protocols for data exchange such as receiving information, answers/queries or order to perform a task. for some tasks, such as health alert surrounding areas, it is no longer just a request for information but cooperative behavior brings into play several kinds of agents. to communicate with others, agent uses interaction protocols. we will there-fore express how this behavior will be realized by defining a more sophisticated interaction protocol than query/response. various protocols are available for negotiating, giving orders, waiting for answers. the interaction patterns that will govern this cooperative behavior will be organized between the agents. interaction protocols. the protocol is a part of the agents' knowledge. in our simulation, agents have a list of protocols they should initiate to answer others. for the moment, we use a simple protocol with two states as represented in fig. : "inform" and "inform back". for example, agent a launches an instance of protocol p , with the state s . the agent a receives a call from a with the performative "information" in the state s . a knows the protocol and searches the next transition; it slips into state s and sends an acknowledgment to agent a . a treats the message and the conversation finishes. the acl fipa compliant performatives are used: • rdcmessage.acl_query_ref for queries/answers, • rdcmessage.acl_request for an order to perform a task and, • rdcmessage.acl_inform for inform/acknowledgment. position in the organization. the last step is to consider an agent's position in organization when he initiates interactions with others. an organization should be a hierarchy or a simple group. for example, to alert neighboring health zone, health center agents must know the surrounding areas of health zone, which is a group or an organization in the multiagent system, and make a decision based on its position in this group. the agent's position in the organization is integrated in the decision loop. agent's internal decision making loop. the previous steps showed agent's skills, agent's complex behavior (internal and social) and the knowledge of interaction protocols. on the hypothesis that each agent gets this information, we can now build the agent decision loop. on one hand purely individual behavior runs only with an agent's context information and does not need other agents to complete the agent goal. on other hand, social behavior involves relationships between agents. an individualcentered approach defines agent at micro level so that interactions with other agents have to be merged with the internal behavior in the agent's decision loop. the individual and cooperative behaviors are both integrated into the decision loop. in the individual behavior, a set of tasks is launched in the internal decision loop. in its decision loop, the agent should have to respond to the message from others, which are part of interaction protocols initiated by other agents or parts of the agent interaction patterns. these tasks have to be synchronized with the messages received from others agents. as an external view, huge decision loops, which are decentralized in the several kinds of agents, seem to be synchronized at the system level. but in fact, each agent decides in what state to pass according to its knowledge and the state of its interactions. agents would collaborate to achieve some objectives. to investigate on health area, rapid ripost team must wait for an order from health zone executive team. the later receives health data every week from health center and checks if the threshold of the followed pathology has been reached. the same collaboration is needed between rapid ripost team and health area, rapid ripost team and laboratory. the sequence diagram (fig. ) gives a snapshot of the kind of collaboration found in agents concerned with an outbreak investigation. message format for interaction. the messages exchanged between agents contain sender and receiver agents, protocol information and data to manage like [sender; receiver; conversation; perform; protocol; inst_prot; state_prot; data]. the data follow a format according to the performative. to interact through a message sent by another agent, a simple protocol is established. for instance when rapid ripost team asks a laboratory to perform exams, he has to first check its state to be convinced that it can answer his request. a simple protocol with acknowledgment is used. the agent changes state when he asks for information and when he receives answers to his request (fig. ) . in a future simulation, a negotiation protocol with a call for proposal to several laboratories will be tested. however, the agent launching the conversation should negotiate among laboratories which one is available, near or powerful. the analyze of the cycle of outbreak response presented on . isolated some individuals playing different roles to achieve the objectives assigned to the riposte process. a simple class diagram (fig. ) gives a quick overview of main actors. health center as agent can exchange message with agent 'health area' to get information about rivers crossing the area of its location. since this knowledge is crucial to anticipate cholera epidemic in raining season, this collaboration is very important. rapid riposte team (rrtagent) investigate on suspicious case in a health area which means visiting population and health centers found in it if the disease requires laboratory analyzes to confirm the case rrtagent must take samples and transmit it to laboratoryagent available. reported worldwide due to fear of economic consequences, often insufficient surveillance systems and a lack of standardized terminology to define a case of cholera. the disease results from the absorption by the mouth of water or food contaminated by the cholera vibrio. after a few hours to a few days of incubation, violent diarrhea and vomiting occur, without fever. in the absence of treatment, death occurs in to days, by cardiovascular collapse (fall in blood pressure) in to % of cases. mortality is higher among children, the elderly and vulnerable individuals. the treatment consists essentially of compensating the digestive losses of water and electrolytes. rehydration is given orally or intravenously, depending on the degree of dehydration. the improvement is noticeable after a few hours and healing, without sequelae, is obtained in a few days. antibiotic therapy is recommended by who only for severe dehydration. in dlm is a disease control direction located in kinshasa which collects the national data for disease monitoring. it provided us with ten years data of cholera outbreak from to november . we extracted the data for kinshasa grouped on its health zones to compare with provincial health division's data. provincial health division's data contained more details about health centers that reported the suspicious cases and theirs health area. we analyze the data from first january to december th . we reported cumulated data of each health zone to a map, as shown in fig. , to find their neighboring and try to suggest the best way to establish collaboration between them in order to stop disease propagation. we focus on two groups of health zones. in the first group we have binza-météo, mont-ngafula, kokolo and kintambo. the second contains limete and kingabwa. our hypothesis was: if actors from each heath zone could exchange disease information with their neighbors as soon as an outbreak happens, it would be possible to reduce the propagation. for example, epidemic began at kintambo on january . as the communication and sensitization weren't establish with its neighbors, some weeks after disease was reported from kokolo and binza-météo. to test and evaluate our approach, we adapted mash simulator developed by lcis lab for a wireless sensor multiagent system [ ] . we focus our simulation to these health zones: binza-météo, mont-ngafula, kokolo, kintambo, limete and kingabwa. the simulation concerns precisely kintambo and limete that register more suspicious case of cholera outbreak during and from them other neighboring health zones were affected. the main idea is to see how the future system would react if each actor of health system could perform its own task with autonomy. these experiences could result to many scenarios and the best of them will be proposed to drc's health system to reduce decision time as each actor can execute his talks according to the knowledge of the environment and the outbreak determinants he will be provided with. we chose two health-zones of kinshasa provincial health division for the simulation. kintambo and limete are health zones that register respectively and suspicious cases with death in . the epidemic began from them and the propagation of disease affected their neighbors with an important amount of suspicious cases. kokolo counted cases while binza-météo registered suspicious cases at the same period. to respond to an outbreak noticed at a health center, health staff of the concerning health center must refer to health zone executive team. in their turn, health zone executive team must refer to provincial health division and provincial health division to central level. this chain of hierarchical contacts can enlarge time decision. in our simulation, we worked with these hypotheses: (i) each health center actor must contact immediately its health executive team as soon as it encounted a suspicious case; (ii) health zone executive team cumulate suspicious case and create an rrt when the disease's threshold is reached; (iii) rrt can contact the nearest laboagent able to answer to his request or to use his information to make decision. we considered twenty-eight health zone executive team in yellow or red, forty seven health center in green or blue, rrt in grey one provincial health division and one medical test laboratories (laboagent). the first suspicious case was detected in health center # in green. figure illustrates those actors working as agents. the below map represents health zones in north of kinshasa. the simulation trace file (fig. ) shows the communication between agents. as they are autonomous they perform their own tasks like "cumulate new cases", "conduct the investigation on health zone # " and manage messages like "realize analyzes from health center", "receive sample to_ analyze" or "report suspicious case detected". hzet agents (# and # ) are waiting for a suspicious case message from any hc. whenever health zone executive team agent receives such a message he computes cases and compare with the threshold of disease monitoring to decide the necessity of building a rrt agent able to investigate in health centers around suspicious case in health area. the visited health center will turn from green to blue color. rrt agent could send samples to laboagent while searching for new cases in health areas. the organization of outbreak riposte could depend on the results from laboagent and investigation report from rrt agent. the agents operate independently: hcagent transmits data to health zone executive teamagent, rrtagent completes a full investigation, laboagent conducts medical testing and transmits results to hzetagent and phdagent which manages all information from health zone executive team under its supervision. message synchronization between kinds of agent is done in the agent's decision loop. a protocol with two states is used and implements kqml-like performatives. the four numbers in the message are " " for inform (give information), " " for query information (ask for an information) and " " for request (ask for a task to be done). the agents communicate and achieve their goal by reacting to messages from others or executing their inner task as response to a query. with positive results from laboagent, health zone executive team sends warning and preventive measures to his all health centers. phdagent can also alert the surrounding health zone executive teams. in this paper, we have showed how multi-agent system can improve the organizations' tasks in order to decrease the time to response when an epidemic disease is suspected or detected. a main research result can be highlighted: the use of a multi-agent method previously dedicated to wireless sensors and applied to human organizations. we have proved that the method was generic enough and gave good results with real data and a hierarchical and complex health eco-system. mas is often used in health domain and our paper's result complete the panel of applications with real data and under eco-system constraints. some limits must be underlined: (i) in order to adapt the method, we have defined hypothesis that strongly constraint the models; (ii) the stakeholders have been introduced in the method only with their job characteristics and adding their experience in the simulation can probably enhance the results. nevertheless the multiagent method can cover only one part of the global problem. we discussed about an organizational method useful to enlarge all aspects of the problem laid down. we propose in the future works to widen the approach to take into account different and complementary aspects: health data collection and transmission, health data quality, improvement of the complete riposte process, improvement of the health system organization. in order to, we propose a three-phases innovation method named chicken useful to supervise and improve the epidemic disease riposte: -phase : define the life cycle of the epidemic disease to watch over. -phase : health data monitoring -phase : riposte and feed-back each phase of this innovation method is build with models, methods' fragments, tools coming from different sciences domains and proposes a road map to improve the riposte and the health data quality. then the multiagent method becomes a method's fragment in the wider method chicken. towards an agent-based model to monitor epidemics and chronic diseases in dr congo programme des nations unies pour le développement: rapport sur le développement humain organisation mondiale de la santé rdc: guide technique pour la surveillance intégrée de la maladie et riposte icts for poverty alleviation: basic tool and enabling sector supporting home based health care in south african rural communities using ussd technology mobile phone text messaging: tool for malaria control in africa improving health information systems for decision making across five sub-saharan african countries: implementation strategies from the african health initiative mobile phones and economic development in africa effects of a mobile phone short message service on antiretroviral treatment adherence in kenya (weltel kenya ): a randomised trial the effect of mobile phone text-message reminders on kenyan health workers' adherence to malaria treatment guidelines: a cluster randomised trial a methodology for agent-oriented analysis and design a methodology and modelling technique for systems of bdi agents desire: modelling multiagent systems in a compositional formal framework voyelles the gaia methodology for agent-oriented analysis and design analysis and design using mase and agenttool prometheus: a methodology for developing intelligent agents bdi agents: from theory to practice agents acting and moving in healthcare scenario -a paradigm for telemedical collaboration designing embedded collective systems: the diamond multiagent method modélisation et gestion de flux par systèmes multiagents: application à un système d'aide à la décision en épidémiologie solutions multi-agents pour la prise en charge à domicile des séniors mise en place d'un système d'information décisionnel pour le suivi et la prévention des épidémies evaluation of disaster response system using agent-based model with geospatial and medical details multi-agent system based efficient healthcare service using multi-agent systems to support e-health services a multi agent system for hospital organization multi-agent systems for e-health and telemedicine a multiagent system enhancing home-care health services for chronic disease management multi-agent system applications in healthcare: current technology and future roadmap a multiagent tool to simulate hybrid real/virtual embedded agent societies usability evaluation of a collaborative health information system -lessons from a user-centred design process multi-level agent-based modeling -a literature survey key: cord- -gr vioor authors: fedorowicz, jane; gogan, janis l. title: reinvention of interorganizational systems: a case analysis of the diffusion of a bio-terror surveillance system date: - - journal: inf syst front doi: . /s - - -y sha: doc_id: cord_uid: gr vioor innovation diffusion theory proposed that adopters—whether individuals or organizations—sometimes reinvent an innovation as they gain experience using it. reinvention can enhance (or impede) the likelihood of an is innovation’s acceptance and further diffusion. this paper reports on a case study of biosense, an interorganizational system that was designed as an early detection tool for bio-terror attacks and subsequently modified to better serve this need as well as to operate as a public health system for pinpointing geographic clusters of dangerous/acute disease outbreaks. by examining the interplay among the political and organizational dynamics and technical properties of the biosense system, we shed light on processes affecting reinvention in an interorganizational context. we discuss our findings in light of theories of the diffusion and reinvention of innovations. we use rogers’ ( ) list of factors supporting reinvention to structure the discussion of the fidelity and uniformity of the innovation within the processes it supports in adopting health services organizations. institutionalization of an innovation is dependent not only on its fit with a variety of user requirements or circumstances, but also on user receptivity toward its implementation processes (goodman et al. ; yetton et al. ) . "reinvention" refers to the changes or modifications made to an innovation following its adoption and the processes by which the innovation is changed by its adopters (rogers ) . complex, process-based innovations that are flexible enough to be reinvented to fit the needs of an adopting organization are more likely to be successfully assimilated into organizational routines. innovative information systems (is) may simplify information processing or analysis tasks, as when an organization adopts a new enterprise system, or the innovative information system may provide access to new data, combinations of data, or new analytical tools, as would be the case when supply chain partners introduce an interorganizational system to share data between buyers and suppliers. the new information system may not necessarily utilize new technologies, but is considered an innovation because it enables changes to extant processes and workflows. since both expected and unexpected changes can take place, care must be taken to align the is innovation with critical organizational tasks, as well as to nurture its adoption and implementation processes (yetton et al. ) . the more flexibility inherent in an is-based innovation, the more likely its reinvention will lead to (planned or unplanned) sustainable improvements in organizational work. however, innovation change agents must also ensure that unmonitored or uncontained flexibility does not result in unnecessary organizational churn or user confusion. when the success of the innovation requires buy-in from many organizations as is true with an interorganizational system, the innovation must be malleable enough to fit the requirements, preferences and processes of each partnering organization while preserving the purpose of the collective entity. striking a balance between the ability to customize systems to individuals' or departments' needs (a key benefit of is flexibility) and information-sharing transparency (a key benefit of uniformity) is an ongoing challenge for many organizations. this paper reports on a case study of a public health interorganizational system which was initially designed and promoted as an early detection tool for bio-terror attacks and subsequently was modified to serve a broader and more routine public health purpose: identifying geographic clusters of communicable disease outbreaks. by examining the interplay among emergent political and organizational dynamics and technical properties of the biosense system, we shed some light on the decisions and processes that led to the reinvention of this interorganizational innovation. the paper is organized as follows. first we review prior studies of innovation, with a focus on key findings about reinvention and related processes affecting or resulting from interorganizational system innovations. we explain the methodology employed for the case study, and then describe the biosense initiative, including the context for, design and development of, adoption and early experience with this interorganizational system and reinvention events that took place in the mid-to-late s. we discuss our findings in light of the reviewed literature and offer suggestions for further research on reinvention of interorganizational systems. literature review innovation diffusion theory proposed that adopterswhether individuals or organizations-sometimes adapt or "reinvent" an innovation as they gain experience using it (rogers ; see also rice and rogers ) . herein, we prefer rogers' term "reinvention" to refer to these innovation changes, to distinguish our work from prior is research where the term "adaptation" describes how organizational processes and procedures are changed to accommodate the innovation, without actual changes to the it artifact itself (see for example cooper and zmud ) . reinvention usually enhances the likelihood of an innovation's acceptance and further diffusion. reinvention may affect an individual user (as when an individual customizes software developed by someone else to suit his/her specific requirements) or an organization (as when a new scheduling system is introduced to reduce patient waiting time in a medical facility, then modified to better suit the needs of the adopting organization and/or its users). rogers ( ) proposed that reinvention can be spurred by a variety of factors, including: although rogers called for further research on reinvention especially from an organizational perspective (versus user-adopted technologies, which have been extensively studied), few researchers have focused on reinvention. hays ( ) studied how state policies enacted as laws were reinvented as they were diffused into subsequent states, finding that policies were reinvented based on a combination of social learning, political characteristics, and contextual factors. lewis and seibold ( ) consider two components of innovation reinvention, distinguishing between fidelity (how well the reinvention matches the original intent of the design or intended use) and uniformity (referring to the degree of similarity of use across users). they illustrate their framework in a single organization by studying characteristics of adopting individuals. when considering an innovation that is intended to be adopted by a large number of potentially dissimilar organizations, studying both aspects of fidelity and uniformity at the organizational level is likely to increase understanding of the importance and complexity of reinvention in a largescale diffusion (informal) or dissemination (formal) effort. many studies have examined individuals' and businesses' decisions to adopt or not to adopt various is innovations (e.g., chen et al. ; plouffe et al. ; tan and teo ) as well as potential adopters' propensity to innovate (e.g., agarwal and prasad ) and their post-adoption attitudes and behavior (e.g., karahanna et al. ; parthasarathy and bhattacherjee ) . yetton et al. ( ) are careful to distinguish between innovation characteristics that are more likely to impact individual task performance, and implementation processes that are apt to affect group task performance. however, few studies (e.g., tyre and orlikowski ) focus on information systems reinvention. one paper, which examined several case studies of the adoption and use of efficient consumer response (ecr) technologies, hinted at reinvention in its conclusion that "each organization will enter into a complex series of interactions with other parties in its industry group … [during which] organizations' knowledge and perceptions of ecr will change, their capabilities will change, and their interactions with industry partners will change." (kurnia and johnston , p. ) . this study also emphasized the importance of understanding the processes related to interorganizational innovations, and the emergent nature of the system evolution. other studies also suggest that is innovations, as compared with other innovations, are especially susceptible to reinvention. drawing on earlier work on "intellectual technologies" (curley and pyburn ; see also wildemuth ) , lee ( ) notes that, unlike traditional industrial technologieswhich, due to physical limitations, only support a narrow range of functionsinformation technologies are inherently flexible and their uses are constrained primarily by the skills and imagination of designers and users. this flexibility is a central property of is, and lee calls for further research on the implications of this flexibility. if flexibility/adaptability is a central property of is, then reinvention should be a central concern of research in the diffusion-of-innovations stream. however, as noted earlier, most studies in this stream of is research focus on individual users' decisions to adopt new technologies. fewer studies closely examine reinvention processes or outcomes, either in intra-organizational or interorganizational contexts. one review of the extensive diffusion-ofinnovations literature (chin and marcolin ) concludes that while much attention has been given to factors affecting potential adopters' attitudes and intentions, further study is needed on "the technological context and interactions such as interface design, data structures, training, and actual usage behavior..." (p. , emphasis added). studying the adoption and use of interorganizational systems by collaborating organizations will give researchers insights into the complex world in which both the characteristics of the technology-based innovation and its implementation process combine to determine the role of reinvention in its long term sustainability. although in many ways health care works under a "business" model, its social mission and public nature lead to many different organizational characteristics that are more complex than would be found in a corporate environment. for example, health care professionals must contend with extensive external vigilance (e.g., laws, regulations and government oversight) and unique funding structures (a mix of internal and external sources, the latter usually limited to specific capital projects and loaded with financial and operational restrictions). in addition, unlike the corporate or government sectors, multiple hierarchies exist in the social networks of the medical professions (west et al. ; dopson et al. ) . doctors have flatter, more informal networks than nurses' hierarchical ones. as a result, doctors are more likely to be effective at influencing peers to adopt or reinvent innovations. these social networks are a dominant means for diffusion of innovation in health care. with their complex organizational structures, tangled regulatory oversight and irregular opportunistic funding for innovations, the health services arena provides a rich and complex background in which to study innovation reinvention and diffusion. an extensive literature exists on the diffusion of innovation in health services delivery (e.g., berwick ) . two recent reviews (greenhalgh et al. ; fleuren et al. ) examined hundreds of published articles; each review proposed a model for enhancing the success of health related innovations and improving the quality of publications in this area. the greenhalgh et al. article concludes with an extensive list of research questions, two of which are particularly relevant to the study related in this paper. they are: "how do innovations in health service organizations arise, and in what circumstances? what mix of factors tends to produce 'adoptable' innovations (e.g. ones that have clear advantages beyond their source organization and low implementation complexity and are readily adaptable to new contexts)?" "how are innovations arising as 'good ideas' in local healthcare systems reinvented as they are transmitted through individual and organizational networks, and how can this process be supported or enhanced?" (p. ) this paper addresses these questions by reporting on a case study of an innovative interorganizational system (biosense) and its subsequent reinvention by its users. we use rogers' list of factors supporting reinvention to structure the discussion of the fidelity and uniformity of the innovation within the processes it supports in adopting organizations. the biosense case study was part of a larger study of interagency information sharing in egovernment (fedorowicz et al. & review of other documents available from public sources (journal articles, news accounts, conference presentations). & interviews with three key informants in [ ] [ ] : a statistician at the cdc who played a significant role in designing the biosense system, and two physicians with public health and statistics training who worked in clinical informatics at two participating hospitals who were key players in the diffusion of biosense. a semi-structured interview protocol was utilized, based on a framework that guided all case studies in the larger project. (see appendix.) in interviews lasting one to two hours each, informants were asked to describe their role in biosense and other public health informatics and/or surveillance initiatives and to discuss political, administrative and technical challenges, as well as their thoughts on directions for future interorganizational systems in this domain. the interviews were recorded and professionally transcribed. the authors compared the interview data with the publicly-available sources (from the cdc website, congressional testimony, and other sources) to triangulate on a timeline of events and key facts about biosense and related initiatives. beyond establishing the facts of the biosense case, our analysis of the data utilized an inductive, grounded theory approach. using the constant-comparative method of analysis (see strauss and corbin ) the authors reviewed the data for themes and sub-themes. analysis started with identification of informants' views regarding political, administrative, and technical aspects, as set forth in our interview guide (appendix). then, consistent with grounded theory, the authors utilized open coding to identify portions of the interview and other data that did not readily fall into the pre-defined categories, along with puzzles and apparent contradictions in the accounts of events and perspectives. two of the initial informants were re-contacted-one via email and the other via several telephone conversationsfor clarification of some of these open issues; they were encouraged to add further comments. a case history was then prepared, which was reviewed by two of our informants. minor changes were then made based on their clarification of events and perspectives. in public health, "surveillance" is the systematic gathering of data about disease outbreaks, so that priorities can be set for dispensing vaccines and medicines, instituting quarantines or taking other measures to contain an outbreak and conduct follow-up work. surveillance is not new; the united states began monitoring cholera, smallpox, plague and yellow fever in . in all states were required to report on "notifiable" diseases, and in cdc was given responsibility for aggregating and publishing the states' surveillance data. unfortunately, many diseases are tracked via separate data collection processes and systems, leading to a proliferation of incompatible applications and databases (potts and fraser , p. ) . realizing that these incompatibilities place constraints on the ability of states to collaborate during widespread outbreaks, many public health experts have called recently for greater coordination in traditional public health surveillance activities. in the cdc formed a health information and surveillance systems board to coordinate public health surveillance efforts, with broad representation from state and regional public health agencies. in development of the specifications for a national internet-based health alert network began, and planning soon followed for development of a national electronic disease surveillance system (nedss). cdc announced in : "nedss will electronically integrate and link together a wide variety of surveillance activities and facilitate more accurate and timely reporting of disease information to cdc and state and local health departments. … nedss will include data standards, an internet based communications infrastructure built on industry standards, and policy-level agreements on data access, sharing, burden reduction, and protection of confidentiality." (potts and fraser , p. ) traditional public health disease surveillance, while vital, operates at a slow pace based on verified outbreaks of notifiable diseases. it is not very effective in responding quickly and effectively to outbreaks of rapid-onset, highly contagious diseases. for example, in a waterborne parasitic infection in milwaukee sickened , and killed people (foldy ) . this traumatic event sparked several local early detection initiatives in that region, but over the next decade little progress was made on a nationwide basis. according to centers for disease control and prevention director dr. julie gerberding, traditional surveillance procedures, which aim to confirm that a particular disease is involved, emphasize data accuracy and completeness at the expense of timeliness. dr. gerberding stated that during the post- / anthrax attacks in fall of "the style of not wanting to make a decision until you have all the data gathered and you have the nice tied-up package was a deterrent to effective decision making on a day-to-day basis" (as quoted in altman ; see also henning ; stolberg and miller ) . criticism of cdc's problematic response to the anthrax attacks helped to direct lawmakers' attention to the need for a new kind of surveillance system that would focus on potential bio-terror attacks. in contrast to traditional surveillance which uses data about confirmed diagnoses, near real-time syndromic surveillance aims to "identify illness clusters early, before diagnoses are confirmed and reported to public health agencies, and to mobilize a rapid response…" (henning , p. ) . as compared with disease surveillance, syndromic surveillance analyzes the symptoms that patients are experiencing (versus confirmed diagnoses, which of necessity come later). with this context in place, we now introduce biosense, followed by a discussion of its reinvention led by its early adopters and proponents. . in the same year, harvard medical school physicians in the health care informatics program at children's hospital medical center in boston began developing a pre-diagnostic syndromic surveillance system. both initiatives involved capturing patient chief complaints data. dr. kenneth mandl recalled that interest in bio-terror surveillance was already rising before september , and accelerated rapidly after the attacks: "i started the bio-surveillance program here in after discussions with darpa and the hopkins applied physics lab. it was a very early concept at the time. the clinton administration was interested in … protecting the public against bio-terrorist threats [by] … the use of medical and "nontraditional" data sources for purposes of surveillance. [based on a proposal prepared in ] we received funding from the agency for health care research and quality in for a bio-preparedness contract. the work we were doing became very, very popular in . [even before the / attacks], early in the federal commitment to bio-surveillance went from $ million a year to more like $ million a year. after the attacks in , things really heated up. since we were already on the ground and running, we expanded quite rapidly and i developed a contract with the massachusetts dept of public health to run the massachusetts surveillance system (mss)." thus, before september , , work was already underway (in boston and pittsburgh) to develop regional syndromic surveillance systems for rapid detection. at the national level, efforts were initially focused on developing standards and common systems for traditional disease surveillance, but after the / anthrax attacks the cdc sponsored work on real-time pre-diagnostic syndromic surveillance at the national level, with the biosense system. the biosense project was proposed in and formally funded in spring , shortly after the beginning of the war in iraq. two other national bio-terrorism initiatives were also funded: biowatch, a network of sensors which capture air samples in key cities to detect known bio-terror agents; and bioshield, which aims to rapidly develop, move and store vaccines and therapeutics such as antibiotics as soon as an outbreak is identified. figure illustrates the relationship of biosense with other u.s. public health activities and systems. nedss is responsible for routine disease surveillance (primarily the traditional but consolidated notifiable disease program, which emphasizes reporting of confirmed disease outbreaks), while bio-sense is for syndromic surveillance, i.e., less precise early detection, based on chief complaints, laboratory orders and other data that help identify symptom clusters (henderson ) . table (above) summarizes the evolution of disease surveillance and related work that led to the launching of biosense. with this background on the mission and motivation for developing biosense, we turn now to an examination of how the system and its users adapted to meet a wider spectrum of individual and societal needs. as initially envisioned the focus of the cdc biosense initiative was on developing an early detection tool for bio-terror attacks. the idea was to quickly identify clusters of patients with symptoms related to known biological agents in eleven syndrome groups (fever, respiratory, gastrointestinal, lymphadenitis, specific infection, localized cutaneous lesion, rash, neurologic, botulism-like illness, hemorrhagic illness and severe illness or death; see ma et al. ) . biosense was designed to identify a medium to large scale bio-terrorism outbreak rather than a small-scale/ narrow scope attack (such as the anthrax-by-mail attacks that occurred in the aftermath of / ) which would likely be picked up by alert clinicians. according to one source, "the principal underlying premise … is that the first signs of a covert biological warfare attack will be clusters of victims who change their behavior because they begin to become symptomatic." . from participating hospitals and clinics, biosense would capture prediagnostic data such as chief complaints (a "chief complaint" is the primary symptom that a patient describes upon arrival at an emergency room or clinic) and laboratory orders (which reveal what evidence the doctor is looking for, as compared with lab test results, which help to confirm the doctor's hunch). chief complaint and lab order data were already being captured and stored in electronic form at many hospitals and clinics. the biosense interorganizational system included tools to aggregate data from multiple locations and to perform statistical analyses that would help to identify abnormal clusters of chief-complaints symptoms, lab orders, and other indicators of bio-terror attacks (loonsk ; loonsk et al. ; ma et al. ; mandl, et al. ) . data would be captured in near-real time, aggregated daily, and analyzed once a week unless an unfolding situation warranted a quicker analysis. biosense participants included department of defense (dod) hospital emergency rooms and clinics, veterans affairs (va) emergency departments, va clinics, and lab corp testing locations and patient service centers. when phase i pilot testing began in (gerberding ) the following data were captured: diagnostic codes for chief complaints in dod and va clinics and emergency rooms (up to four codes per patient), several medical procedure codes, laboratory test orders (about , specimens from lab corp daily), and biowatch sensor data. as of , the biosense system collects data from hospitals, department of defense facilities, and veteran's administration facilities in states. biosense was an is innovation that was reinvented in several ways following its adoption. as discussed in the literature review, rogers ( ) found that reinvention can be spurred by one or more of six factors: changes in adopters' knowledge about what the technology can do, adopters' attempts to simplify innovations that are perceived as overly complex ("simplification"), adopters' need to customize a general-purpose tool ("customization"), adaptation to multiple problems, local "pride of ownership", and encouragement (or pressure) by a change agent. consistent with rogers, we found evidence of reinvention corresponding to many of these factors. recognizing that not all of these factors pertain to the reinvention of a particular innovation, in the following sections we emphasize where and how these factors come into play as we present how biosense was adapted by its users and designers. to begin, we note adaptation-related issues related to the fidelity and uniformity of the biosense innovation, in its dissemination among adopting organizations. when proposed in , biosense was planned as an early detection tool for bio-terror attacks, using "real-time syndromic surveillance." as users learned about how the system worked (signaling changes in adopters' knowledge), some began to doubt the system's ability to achieve its intended goal of real-time detection. several argued that an alert physician was more likely to note an early instance of symptoms indicating a possible bio-terror attack or unusual disease outbreak, as had happened in the anthrax attacks. so, very early in the biosense rollout, the first shift came in re-articulating the goal of biosense away from noting the first instance of an occurrence of symptoms that might point to an outbreak, to what the designers referred to as "situational awareness": using data to confirm (or disconfirm) an outbreak, to pinpoint where resources are most needed and to direct resources away from localities that do not show clusters of chief complaint symptoms. biosense rapidly delineates geographic clusters of diseases or symptoms, and (even more important, in the view of one informant) helps to verify that a possible cluster is not cause for concern. our informants emphasized also that biosense was designed to spot geographic and time trends in sanitized (or de-identified) data, not to reveal nuances of individual patient data. thus, as adopters gained more knowledge about the system, they were able to adapt its use to be more effectively employed, reflecting in this instance a small shift away from the system's initial mission of "first detection" to "situational awareness." later, its mission and design were broadened further to support more routine disease surveillance activities (such as quickly identifying clusters of patients with symptoms of flu), representing a significant departure from its original intent (illustrating its adaptation to multiple problems). below, we discuss the factors that led to this and other further changes of mission (infidelity) and its use in both bio-terror and natural epidemic detection (reduction in uniformity). public accounts reveal changes in participants' views about biosense. in , joseph henderson, the cdc's director of the office of terrorism preparedness and emergency response, in testimony before a congressional committee stated: "biosense is being developed to support early event detection activities associated with a possible bio-terrorism threat" (henderson ) . as time passed and criticism intensified, participants came to realize that the biosense tools that allowed chief complaints data to be shared and analyzed among hospitals could, with some modification also be used to confirm suspicions of naturallyoccurring outbreaks, such as sars or west nile virus, as well as food-or water-borne contamination and other communicable diseases. by , the cdc's cio, jim seligman, was quoted as follows (wolfson ) : "we want to make sure the investments we make for terrorism will benefit daily public health, whether we have an event or not. we are trying to avoid building another stovepipe system that would only apply to terrorism and would sit idle . per cent of the time. the surveillance we are doing for a bio-terrorism event will certainly pick up a naturally occurring event at the same time." seligman's encouragement of reinvention shows how biosense's designers were accepting of changes to its initial mission, in that they promoted flexibility of design (reducing fidelity to the original mission) and use (reducing uniformity of user domains). by doing so, he increased the likelihood of institutionalizing the system by promoting its use in routine situations, and it was no longer reserved for detection of very unlikely events. an article published in reflected the change in mission for biosense. the article noted that when considering new data sources for the system, the following criteria were employed (per loonsk et al. earlier presentations about biosense had not listed the "dual-use" criterion. asked about this, an informant explained that in the absence of bio-terror attacks, a consensus had developed among participating hospitals, statisticians and public health officials that they should expand (or customize, in rogers' terms) the system to include symptoms and complaints associated with naturally-occurring outbreaks. with this move to officially condone the dual uses of the system, its designers became supportive change agents for biosense's institutionalization into users' routine processes. the timing was right: no doubt the implications of the sars epidemic abroad was not lost on the biosense participants, and over the next few years the threat of avian flu was also of great concern worldwide. in fall one interviewee described the change in focus as follows: "for a few years people were saying 'the only thing biosense is any good for spotting is influenza.' now it's like, 'holy cow, this is good for influenza!' there's a lot of federal pressure on biosense to beef up in preparation for monitoring avian flu. last year you could say, 'oh it's just influenza.' this year we're very concerned about influenza." here, the "federal pressure" reflects the encouragement of the funding source acting as a change agent for adapting biosense's mission to cover more routine situations. yet a third potential focus shift was hinted at when one interviewee noted that the statistical tools used in biosense to analyze human syndromes could be applied to outbreaks among animals. if enacted, this would be an even more significant example of adaptation to multiple problems, and would be a more severe example of a uniformity departure than the shift from bio-terrorism to naturally occurring epidemics. thus, while the initial intent was narrowly focused on the design and use of biosense for detecting bio-terror attacks, today biosense has a broader, more routine public health mission, and some participants are exploring a further broadening to include animal outbreaks. biosense has continued to evolve as it becomes more widely adopted and as complementary technologies (chircu and kaufman ) become available to support an even more ambitious mission. as can be seen in fig. , the mission of biosense has recently been reinvented yet again in response to changes in the environment. going forward, biosense will aim to "comprehensively monitor the healthcare system of the united states for evidence of acute health threats to the public" by focusing on "early event awareness, health situational awareness, and public health response" ( lenert ) . as can be seen in fig. , the cdc is proposing to set up regional collaboratives to work with health information exchanges (hies) and regional health information organizations (rhios), to collect and analyze clinical data identifiable at the facility level. these new organizations represent pressure by the cdc acting as a change agent to adapt biosense to an even broader set of problems, again demonstrating the flexibility of the system to fit the processes designers and users want it to support. this flexibility permits changes to operational processes in addition to technological enablement, as seen in the next section. . changes to systems and processes yetton et al. ( ) noted that successful adoption at the individual level more frequently involved adjusting innovation characteristics to individual task needs, and at the group level, innovations are significantly impacted by their implementation processes. individuals' reactions to biosense clearly demonstrated the need for simplifying data entry. minimization of manual input was considered especially important. early syndromic surveillance efforts relied on doctors, nurses and administrators to manually fill out checklists of symptoms and other data. this was found to be infeasible; clinicians feel they are simply too busy providing care to take extra time to record information that is not immediately valuable to them. one doctor noted: "if for your bio-surveillance system you require a nurse, administrator or physician to click off new data elements on a daily basis or a per patient basis-even worse!-you're no longer in business." fortunately, in the early years of this century electronic medical records became more pervasive, and in turn more data thus became available in encoded digital form for the biosense effort, enabling adopters to simplify the biosense data capture processes and to increase the likelihood of its success. still, slow progress in health-care standards-setting efforts for free-text clinical descriptions posed an impediment. while much clinical transaction data is now recorded in the national hl standard, free-text descriptions of chief complaints are not yet standardized (there is not yet a fully standardized nomenclature for physicians to describe what they hear from their patients). the codes for various procedures and tests are also not yet uniform; while these tend to be homogeneous within a care setting, they are not standardized across settings. thus, the biosense system and its related processes are constrained by the need for changes in health-care processes and systems to yield better and timelier information for rapid analysis. another challenge pertained to incompatibilities between syndromic surveillance based on pre-diagnostic data such as chief complaints, versus traditional public-health processes. this represented an impediment to adopting biosense, as users were concerned about how its use might require changes to existing processes. one interviewee explained: "public health procedures are geared to receiving a single notification of a possible outbreak, during working hours. and, their processes are not designed for rapid reaction to outbreak news. the emphasis is on telephoning individual clinicians, with a focus on individual-case follow-up." designers were called upon to reiterate that "most of our efforts are really not just in counting cases, but in seeing trends and corroborating." users needed this encouragement to be able to distinguish between biosense's syndromic surveillance methods and processes and prior public health efforts in disease surveillance. more recently, biosense designers have begun to take steps toward integrating biosense with the national electronic disease surveillance system (nedss), bringing together syndromic pre-diagnostic (e.g., chief complaints, lab orders) and diagnostic (e.g., lab results, physician diagnoses) data (lenert ) . this illustrates the continued pressure by adopters to advance the use and usefulness of biosense by further customizing the tool and expanding its reach beyond its initial mission (infidelity). because it is a public good commodity, biosense designers must consider both these users' needs and the needs of society as a whole in establishing its mission and design, as discussed in the next section. rogers proposed that reinvention sometimes occurs thanks to encouragement by a change agent and this turns out to be critical within health care. early proponents included physicians and others who were recognized nationally for their leadership in health information. these champions took advantage of their considerable professional social networks to advocate for system adoption. however, we note that multiple change agents (cdc, state and local public health officials, the media) exerted both positive and negative political pressures which affected the reinvention of biosense. for example, the addition of the "dual use" criterion in could well have been motivated by a desire to find common ground with critics. there were also other political issues. as noted earlier, following the / attacks (and post- / anthrax attacks as well as the iraq war) the total amount of funding for syndromic surveillance increased greatly. in turn, however, this engendered competition as various parties sought to protect their turf. some funds that were previously earmarked for states were transferred to the cdc, which generated some controversy, illustrating the pull of local pride of ownership of a patchwork of systems vs. the added benefits of a national integrated effort. seth foldy, m.d., a spokesperson for the national association of county and city health officials, testifying in before the u.s. house of representatives articulated the need for improved information sharing between health care providers and public health and safety officials: "in the setting of a communicable disease, a covert bio-terrorism attack, or an environmental emergency, poorly informed decisions by either party result in missed opportunities to prevent injury or illness, sometimes on a massive scale…. improving the timeliness, completeness, and accuracy of information exchange in both directions is a critical goal …" (foldy ) . another controversial aspect centered on participants' expectations about the likelihood of future bio-terror attacks. the fall anthrax attack was only the second deliberate large-scale bio-attack in u.s. history (the first was the contamination of oregon salad bars by a cult in ; see mishra, ) . as of this writing, the u.s. has seen no large-scale bio-terror attacks since . as time passed, public health officials and informatics coordinators at participating hospitals became concerned that criticism of the initiative might intensify along with the public's perception that bio-terror was unlikely to affect them. by increasing the call for biosense to expand beyond its initial, limited mission, this array of change agents encouraged expansion of the system to cover additional problems, further demonstrating the adaptability of the underlying initiative. foldy also criticized biosense as competing with the broader consolidated public health information network that was far from completed: "biosense … is a worthy, if highly experimental, project for the nation. however, it is essential to remember that it will be local health departments that, when alerted to abnormal disease trends, will do the legwork to validate such suspicions and actually manage the outbreaks. reduced funding for state and local agencies defeats the overall vision. we urge congress and the administration to support instead the larger cdc vision of a public health information network (phin), an enterprise model of information management across local, state, and federal systems, not just a single component. both nationwide projects and local capacity need support, not one at the expense of the other." (foldy, july ) as of , the cdc has plans to incorporate regional versions and act as a national "broker" for surveillance data (lenert ; also see fig. ). this reflects a move to integrate with the myriad of linked public health monitoring systems envisioned by the cdc, congress and the department of homeland security. with these longer range objectives, the collection of surveillance systems with which individuals and organizations interact will employ common, combined and automated data feeds, in effect simplifying input requirements and user effort. the continued reinvention of biosense into a regionally-based and thus customized component of the country's larger public health surveillance system demonstrates the flexibility of the program and its success as a sustainable means to addressing this complex problem. this case study relied on information in publicly available sources, triangulated against information obtained in interviews with three key informants. while these informants were well positioned to provide useful insights, we are certain that much more could have been learned had we been able to interview a greater number of biosense participants. to fully analyze the biosense case, it would be necessary to closely observe participants' behaviors and concerns during its implementation. in contrast, we relied on a limited number of interviews coupled with information found in public accounts. since innovation diffusion is a dynamic process, an ideal research design would be longitudinal. for example, a study reported by tyre and orlikowski ( ) revealed that the process of reinvention (which they termed "technological adaptation") was heavily influenced by timing, with the greatest amount of reinvention taking place shortly after adoption. routinization subsequently led "the technology and its context of use to congeal, often embedding unresolved problems into organizational practice." rather than observing a process of continuous adaptation (as was predicted by many in the literature) tyre and orlikowski observed long periods during which the innovation was not changed, punctuated by occasional short-lived episodes of reinvention. thus, longitudinal studies remain the gold standard for learning about post-adoption behaviors including reinvention. also, organizational and interorganizational is innovations are more likely to be complex than other innovations and thus require a steep post-adoption learning curve (fichman and kemerer ; purvis et al. ) , which could affect reinvention. furthermore, to derive full value from the adoption of an innovation, an organization may need to invest in complementary technologies and processes (chircu and kauffman ; mcafee and brynjolfsson ) . so, while the properties of the focal innovation can constrain or enable reinvention, it may well be that the properties of the complementary technologies and aspects of the complementary processes may also affect reinvention. biosense is a good example of a flexible is innovation that users adopted and subsequently reinvented. it illustrates the importance of attending to both users' needs and requirements, and the implementation processes controlled by its designers and other change agents. in health care, initiatives need to balance user viewpoints against benefits to the public good, a role undertaken by government change agents. thus, government support of public health initiatives is necessary to garner the funding for wide-ranging interorganizational initiatives. government involvement also opens access to the vast pools of extant data as well as attracting analysts and other users who would gain from its public good benefits. the biosense system, as initially designed, provided a flexible foundation that supported its subsequent adaptation to other applications. the database, analytical tools and coordination structures were aimed at bio-terror preparedness, yet this foundation proved to be well suited (with modifications) to a much wider range of applications which were adapted over time to support the broader, syndromic surveillance activities for influenza and other common outbreaks. there is no indication in either the interview data or the public record that these subsequent broader applications were anticipated when biosense was first proposed. yet as adopters began to work with the system, and technology emerged that enabled broader and easier application to other societal needs, many individuals worked to expand the mission of the system and proposed its use as a flexible tool for many types of analyses. the biosense case reveals evidence that is consistent with rogers' observations about drivers of innovation reinvention. his six factors contributing to innovation reinvention (adopters' knowledge, simplification, customization, adaptability, pride of ownership, and change agent pressure) were clearly evident in the design and implementation of biosense. there was no single stakeholder that initiated the expanded mission of biosense. rather, knowledgeable adopters reacted to the initial system with suggestions for simpler design and less intrusive processes. they recommended expanding the system to include syndromic surveillance for rapid onset diseases such as influenza and later for an even broader set of medical conditions. meanwhile, some stakeholders balked at replacing locally developed efforts with one imposed on them by a national body. physician opinion leaders promoted and eased implementation efforts among their professional peers. the cdc and other change agents worked to meet both user demands and societal needs for early detection, regardless of the medical origin. the cdc, as initiator of biosense, worked with other change agents to obtain mission-oriented funding. taken together, it is clear that many factors combined to shepherd the system from its origin as a "good idea" to one likely to achieve significant societal benefits. no single concern or reaction determined the reinvention path taken by biosense. instead, many stakeholders contributed to the reinvention through the perspective of all six of rogers' factors, even while recognizing that the system's adaptability was a key contributor to its reinvention. these factors served to reinvent the mission over time, leading to increased flexibility by adapting biosense to a broader scope of problems. biosense continues to be an important tool for use in the (hopefully rare) event of a bio-terror attack, but in addition it is already serving as a useful tool for use by public health officials and clinicians in more common outbreaks of naturally occurring acute diseases. the increase in flexibility reduced fidelity to the initial mission and reduced the uniformity of use by customizing it for other purposes and groups of users. what is the role of reinvention in the diffusion of interorganizational systems? we return to the two questions posed by greenhalgh et al. ( , p. ) to highlight biosense findings that would answer this question: "how do innovations in health service organizations arise, and in what circumstances? what mix of factors tends to produce 'adoptable' innovations (e.g. ones that have clear advantages beyond their source organization and low implementation complexity and are readily adaptable to new contexts)?" in this case, we saw a health service innovation arise as a result of the convergence of a political opportunity and a technological solution. on the medical side, we reported on the work of a dedicated set of physician change agents who recognized a gap in an important public health area and saw how information technology could assist in addressing it. they used their extensive professional networks to obtain funding to demonstrate how patient data could be repurposed to detect patterns among symptoms and treatments. at the same time, the government was intent on finding a way to address the homeland security fear of a bio-terror attack, which loosed the purse strings to fund syndromic surveillance projects. the critical events of / and the anthrax scare plus the availability of data collected in health care is further helped to grown nascent programs. in the case of biosense, we see how political feedback, monitoring of social and technology indicators, or the occurrence of critical events can serve as the impetus for a public sector initiative (kingdon ) . designers and supporters of the system were flexible and encouraging in reaction to user requirements and needs. the system itself was adaptable to expanding requirements and user reticence to change processes. every effort was made to not impose additional costs (in time or money) on adopting organizations, and both local and collective benefits accrued from the system's adoption. one very significant "lesson learned" bears note here. the system as originally envisioned was intended to detect infrequent or even highly unlikely events (a bioterror attack). given the low likelihood of such an occurrence, the added value of the system to any one locale could easily be overshadowed by the added "cost" of complying with its extensive data entry requirements. by extending its coverage to more detection of conditions that occur more frequently (such as influenza), the value of the system increased to adopting organizations. the incorporation of a new biosense influenza module for the flu season is evidence of this transition (lipowicz ) . indeed, prior research has found that routine use of a system that also supports emergency situations can greatly increase the acceptance of such a system. for example, the public safety network capwin was initially envisioned to support largescale emergency collaboration. it was only when its value was demonstrated for day-to-day public safety support that it gained a critical mass of adopters (fedorowicz et al. (fedorowicz et al. , . adopters and designers of biosense reached a similar conclusion when they added the "dual use" criteria of supporting both bioterror attacks and natural outbreaks. "how are innovations arising as 'good ideas' in local healthcare systems reinvented as they are transmitted through individual and organizational networks, and how can this process be supported or enhanced?" the case also clearly demonstrates the growth of a 'good idea' from its local roots (in massachusetts and pennsylvania) to a national effort (biosense) to the broader network of linked surveillance systems planned for implementation in the next few years. in addition, the case illustrates how users' reactions to features of an innovation can motivate changes, such as the need to repurpose existing data to deal with users' objections to collecting any new data items. the expansion of biosense to cover both bio-terror attacks and natural outbreaks, and from first awareness to situational awareness, and finally from syndrome to disease detection illustrate several stages of reinvention to address multiple problem areas and the addition of other groups of users. because it is a large and complex interorganizational system, the role of both internal and external change agents became clearly evident. the case also shows the important role of physicians' professional social networks in the diffusion process in health care. the involvement of physician change agents, supportive politicians, and thoughtful users was key, as they collectively implemented a system that was minimally intrusive yet provided assistance for a growing set of problem areas. there are still many signs of adaptation, expansion, and integration in the public health surveillance landscape. biosense continues to adapt and expand its operations. for example, in , plans included adding the new influenza module, connecting to health information exchanges and the national health information network, federating with state and local surveillance data bases to create a national system, and integrating lab reporting with nedss. nedss itself is seeking funding to move into twelve remaining states (weiss ) . other efforts to detect disease outbreaks continue to develop in parallel with biosense. children's hospital in boston is now promoting its new system healthmap, which scours web sources using rss feeds to detect outbreaks around the world (havenstein ) . thus, researchers will continue to be able to study the development of biosurveillance systems over time, to identify patterns of adaptation and better understand the motivations for observed instances of reinvention. furthermore, the domain of emergency response adds a special urgency to this stream of research. in the case of biosense, we are happy to report that our nation has not, at this writing, experienced the sort of bio-terror attack for which it was originally designed and for which it continues to stand at the ready. however, should such an attack occur, there would be great value gained in closely studying how biosense is used in the immediate aftermath and whether such an event would lead the biosense designers and/or users to call for further changes in the system or related processes (such as integration with the biowatch system, which utilizes sensors to capture air samples suggestive of biological or chemical warfare). our results are highly suggestive that the phenomenon of interorganizational systems reinvention is worthy of further, and closer, attention, especially in the domain of emergency response. finally, we concur with lee ( ) , that the flexible adaptability of information systems is an under-studied but important phenomenon. the biosense case leads us to propose that reinvention of information systems is more likely to occur, and the degree of reinvention is likely to be more extensive, than would be true for other innovations. this case illustrates the complexity of reinvention and adaptation within interorganizational systems, particularly the interplay of stakeholder inputs and reactions that can be mapped within the reinvention framework. given the constellation of actors and events affecting systems designed for interorganizational information sharing and collaboration, we believe that in-depth longitudinal case studies offer the most promising methodological avenue for documenting and interpreting the diffusion of interorganizational systems innovation. catalyst prior events/collaborations that provided experience and develop relationships among key participants. events, such as a highly visible disaster or system failure, that triggered the collaboration or propelled it forward. influential supporters within participating organizations or other stakeholder groups. legislative and regulatory requirements that gave rise to a collaboration or constrained its implementation. governance organizing agreements and structures (boards, steering committees, etc.). vision and goals of the collaboration, initially and as the system matures and new participants join. implementation changes required in organizational processes and relationships to support the collaboration. training, staffing, change management. financing funding for the system design and implementation. plan for the long term financial and operational viability. legacy systems previously-installed applications or databases that constrained the design or capabilities of the new system. decisions regarding data sources, definitions, ownership, access rights and restrictions, and stewardship. standards and sourcing criteria decisions regarding de jure or de facto standards data, devices, and interoperability. decisions regarding use of open-source or commercial software for back-end and user-facing technologies. congress authorizes us marine hospital service to monitor cholera, smallpox, plague and yellow fever first summary of notifiable diseases from states all states provide monthly summaries of notifiable diseases cdc assumes responsibility for notifiable disease data collection and publication steering committee on public health information and surveillance system development national electronic disease surveillance system (nedss) project launched. real-time outbreak & disease surveillance (rods) system under development at u. of pittsburgh medical center. real-time syndromic surveillance system proposed by children's nedss architecture v . and public health conceptual data model v nedss assessment and planning phase started in locations. nedss architecture v . , logical data model overview v . , and logical data model data dictionary published cdc recommends that the american college of emergency physicians adopt nedss standards. public health and social services emergency fund provides $ billion for state and local public health preparedness nedss base system v . released and made available to all states. new $ billion preparedness award to states and public health agencies, with stipulation regarding phin standards claire broome states that biosense part i is operational (phase i pilot testing) and includes data from an initial set of data providers such as dod and the veterans administration describes the phin functional requirements for systems implemented to collect, integrate, and analyze data from heterogeneous information sources for the early discovery of a potential public health emergency biosense v . released biosense reported collecting data from hospitals, dod facilities, va facilities a conceptual and operational definition of personal innovativeness in the domain of information technology at disease centers, a shift in mission and metabolism. the new york times disseminating innovations in health care consumer acceptance of virtual stores: a theoretical model and critical success factors for virtual stores the future of diffusion research. the data base for advances in information systems limits to value in electronic commerce-related it investments information technology implementation research: a technological diffusion approach intellectual technologies: the key to improving white-collar productivity no more magic targets! changing clinical practice to become more evidence based the egovernment collaboration challenge: lessons from five case studies a collaborative network for first responders the assimilation of software process innovations: an organizational learning perspective statement on behalf of the national association of county and city health officials before the subcommittee on technology, information policy, intergovernmental relations and the census, house committee on government reform. hearing on "health informatics: what is the prescription for success in intergovernmental information sharing and emergency response? determinants of innovation within health care organizations: literature review and delphi study implementing a national biodefense strategy. testimony before the u.s. house of representatives committee on homeland security, subcommittee on prevention of nuclear and biological attack development of level of institutionalization scales for health promotion programs diffusion of innovations in service organizations: systematic review and recommendations. the milbank quarterly infectious disease surveillance . : crawling the net to detect outbreaks influences on reinvention during the diffusion of innovations cdc's disease surveillance systems efforts. testimony before the subcommittee on emergency preparedness and response, select committee on homeland security, united states house of representatives what is syndromic surveillance? information technology adoption across time: a cross-sectional comparison of pre-adoption and post-adoption beliefs agendas, alternatives, and public policies the need for a processual view of interorganizational systems adoption researching mis exchange of health information between public health and clinical care: the vision, challenges, and benefits innovation modification during intraorganizational adoption healthy opportunity: biosense project can bring dollars and prestige to winning contractors the biosense update. presentation biosense: a national initiative for early detection and quantification of public health emergencies implementation of laboratory order data in biosense early event detection and situation awareness system implementing syndromic surveillance: a practical guide informed by the early experience investing in the it that makes a competitive difference a heightened alert for bio-terrorism: detection system is keeping health officials apprised. the boston globe understanding postadoption behavior in the context of online services richness versus parsimony in modeling technology adoption decisions: understanding merchant adoption of a smart card-based payment system national electronic disease surveillance systems stakeholders meeting report. cdc: march the assimilation of knowledge platforms in organizations: an empirical investigation reinvention in the innovation process diffusion of innovations bio-terror role an uneasy fit for the cdc. the new york times basics of qualitative research: grounded theory procedures and techniques factors influencing the adoption of internet banking windows of opportunity: temporal patterns of technological adaptation in organizations syndrome and outbreak detection using chiefcomplaint data: experience of the real-time outbreak and disease surveillance project seven years and counting: national diseasetracking system still unfinished hierarchies and cliques in the social networks of health care professionals: implications for the design of dissemination strategies an ounce of prevention: jim seligman, cio, centers for disease control. cio insight. online at www successful is innovation: the contingent contributions of innovation characteristics and implementation acknowledgements we wish to thank our biosense contacts for their assistance on this case, and the ibm center for the business of government, which provided support. we also thank christine williams, who contributed valuable insights on this case and others in the broader study. interview and analysis guide (from project documents, web sites, and interviews) jane fedorowicz, the rae d. anderson professor of accounting and information systems, holds a joint appointment in the accountancy and information & process management departments at bentley university. dr. fedorowicz earned ms and phd degrees in systems sciences from carnegie mellon university. she is principal investigator of a national science foundation project team studying design issues for police and government agency collaboration using public safety networks. she also served as principal investigator for the bentley invision project, an international research team housed at bentley examining interorganizational information sharing and the coordination infrastructures supporting these relationships in supply chain, government, and health care. dr. fedorowicz has published over articles in refereed journals and conference proceedings. the association for information systems recognized her contributions to the information systems field by naming her an ais fellow in .janis l. gogan holds edm, mba, and dba degrees from harvard university. a member of the information & process management faculty at bentley university she teaches it management courses and conducts field-based research on complex it projects, inter-organizational information sharing under time pressure, and it-enabled innovation in health care. dr. gogan's publications include teaching cases which have been taught in u.s, european, australian and asian schools, and more than papers in refereed conference proceedings and journals (such as communications of the association for information systems, electronic markets, international journal of electronic commerce, and journal of management information systems). key: cord- -ljc ywy authors: hamaguchi, ryoko; nematollahi, saman; minter, daniel j title: picture of a pandemic: visual aids in the covid- crisis date: - - journal: j public health (oxf) doi: . /pubmed/fdaa sha: doc_id: cord_uid: ljc ywy as a global crisis, covid- has underscored the challenge of disseminating evidence-based public health recommendations amidst a rapidly evolving, often uncensored information ecosystem—one fueled in part by an unprecedented degree of connected afforded through social media. in this piece, we explore an underdiscussed intersection between the visual arts and public health, focusing on the use of validated infographics and other forms of visual communication to rapidly disseminate accurate public health information during the covid- pandemic. we illustrate our arguments through our own experience in creating a validated infographic for patients, now disseminated through social media and other outlets across the world in nearly translations. visual communication offers a creative and practical medium to bridge critical health literacy gaps, empower diverse patient communities through evidence-based information and facilitate public health advocacy during this pandemic and the ‘new normal’ that lies ahead. the covid- pandemic is rapidly becoming the greatest public health crisis of the new millennium. while frontline clinicians and innovative researchers continue to work tirelessly, effective management of this pandemic requires engagement of the public if we are to curb further rises in cases and safely enter a 'new normal.' however, despite the unprecedented connectedness that we are afforded in , disseminating useful, accurate public health information has emerged as a major challenge-one exacerbated by the exponential growth of unverified covid- -related information on social media platforms. critical health literacy gaps further threaten the equity of information access among racial minorities and other vulnerable communities, which are already being disproportionately affected by the pandemic (e.g. % of african americans aged - in the lowest literacy bracket). [ ] [ ] [ ] in this piece, we propose that simple, validated pictorial presentations of data, or infographics-situated at a unique intersection of the arts and public health-can be effective tools to deliver medical information during this pandemic. visual aids and graphics are a powerful medium and have a long history in the broader field of education research, which suggests that the combination of words and simple images into a unified model enhances learning and information retention. during the current covid- pandemic, visuals have emerged as a particularly powerful vehicle of information dissemination. perhaps, the best-known example is the '#flattenthecurve' graphic, a widely circulated image showing the anticipated effects of social distancing efforts. however, there remains a need for simple illustrated resources that consolidate key public health messages and validated clinical evidence into compact visual aids-especially those that can be seamlessly disseminated through social media outlets to reach diverse patient communities. we addressed this need by creating a single-page infographic designed to educate the public about essential covid- -related content (fig. ). evidence-based information, ranging from mechanisms of transmission and risk factors to comparative epidemiological statistics between influenza and covid- , was compiled and reviewed. we distilled this information into a simple infographic with the goals of (i) informing a layperson reader and (ii) guiding providers through a typical conversation about covid- with a loved one, curious patient or the larger public. in order to cater toward a diverse range of health literacy levels, overly complex medical terminology was avoided (i.e. replacing 'shock' with 'severely low blood pressure'), and each graph was annotated with simple interpretations of the data in accessible language to guide interpretation and circumvent potential 'numerical overload.' the final piece underwent rigorous peer review by a team of physicians, including experts in infectious disease, public health and medical education. in the first week following its release on social media, the infographic reached more than people, with nearly readers sharing it among usa and international medical schools, residency and fellowship programs, local municipal governments and even networks of professional comic and graphic artists. to better reach vulnerable communities at risk of limited access to information, the infographic was shared specifically with physician leaders and organizations focused on eliminating racial and ethnic disparities in healthcare. while virtual validation and increased social media visibility cannot be directly extrapolated to public health impact, they do underscore the synergy between social media and effective infographics in promoting rapid transmission of information across interdisciplinary sectors and bridging disparities in access to health information. importantly, there appears to be a global appetite for simple infographics such as the one we piloted. we received direct requests from readers in multiple countries for non-english language versions, as well as offers from international healthcare professionals and students to assist with these translations. we formed an organized coalition of providers, translators, peer reviewers and dedicated illustrators to assist with the production of versions in nearly languages. each of our translators, many of them dedicated providers and advocates for diverse communities domestically and abroadhas disseminated our infographic with a breadth and speed made possible through the networks of social media and the digitally portable nature of a simple visual. our haitian-creole version has been disseminated to patient communities in haiti, and our spanish version was utilized in a spanishlanguage news broadcast targeting the working-class, spanishspeaking communities of los angeles and san diego. such experiences fuel our hope that this developing multilingual library-made possible through the unprecedented connectedness afforded by social media-will serve to further close linguistic barriers that alienate patient communities amidst the english-dominated flow of covid- -related literature released each day. we have combined medical expertise and creative communication to create a validated, accessible and simple public education tool about covid- . as our understanding of this disease continues to evolve, it will be important to clearly identify the areas of uncertainty in order to mitigate the propagation of misinformation and to reflect new evidence in revisions published in all available languages. in the weeks and months to come, we hope to translate the insights from audience feedback and serial revisions into experience-based recommendations on the design, communication and continual improvement of online visual resources in times of public health crises. as dr. danielle ofri expressed in the inaugural article for this section of the journal, '[a]rts and humanities have the potential to serve as a bridge to connect the population and the individual'. the humanities offer a creative medium in the field of public health, which calls for the unconventional integration of seemingly disparate factors of disease-from the microbiology of epidemics to the complex sociopolitical fabric that shapes health on a population level. the visual arts offer an untapped trove of tools to not only reimagine critical issues, such as patient education and global dissemination of public health information, but also engage in important questions about responsible stewardship of graphic data amidst a modern social media landscape that is increasingly uncensored, rapid and visual. covid- has not only caused great human suffering but also shed light on a rapidly evolving information ecosystem that demands creative solutions for equitable, accessible public health communication. amidst this chaos has emerged a unique role for providers-one combining the identities of physician, translator and information liaison, as well as advocate within the broader public health arena. with this new responsibility comes a fresh canvas to engage the power of visual language as a valuable and versatile currency to facilitate public health advocacy, close critical health literacy gaps and inspire socially responsible action among all patient communities. this work was supported by no additional funding sources. social media and emergency preparedness in response to novel coronavirus piaac proficiency levels for literacy hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease -covid-net, states trends and issues in instructional design and technology rh, sn and djm have no additional contributors, prior presentations of this work or conflicts of interests or disclosures to report. rh, sn and djm have no conflicts of interests to report. key: cord- - crtevc authors: moreno sancho, federico; tsakos, georgios; brealey, david; boniface, david; needleman, ian title: development of a tool to assess oral health-related quality of life in patients hospitalised in critical care date: - - journal: qual life res doi: . /s - - - sha: doc_id: cord_uid: crtevc aims and objectives: oral health deteriorates following hospitalisation in critical care units (ccu) but there are no validated measures to assess effects on oral health-related quality of life (ohqol). the objectives of this study were (i) to develop a tool (ccu-ohqol) to assess ohqol amongst patients admitted to ccu, (ii) to collect data to analyse the validity, reliability and acceptability of the ccu-ohqol tool and (iii) to investigate patient-reported outcome measures of ohqol in patients hospitalised in a ccu. methods: the project included three phases: ( ) the development of an initial questionnaire informed by a literature review and expert panel, ( ) testing of the tool in ccu (n = ) followed by semi-structured interviews to assess acceptability, face and content validity and ( ) final tool modification and testing of ccu-ohqol questionnaire to assess validity and reliability. results: the ccu-ohqol showed good face and content validity and was quick to administer. cronbach’s alpha was . suggesting good internal consistency. for construct validity, the ccu-ohqol was strongly and significantly correlated (correlation coefficients . , . and . , p < . ) with global ohqol items. in the validation study, . % of the participants reported a deterioration in self-reported oral health after ccu admission. finally, . % and % of the participants reported considerable negative impacts of oral health in their life overall and quality of life, respectively. conclusions: the new ccu-ohqol tool may be of use in the assessment of oral health-related quality of life in ccu patients. deterioration of ohqol seems to be common in ccu patients. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorised users. during the last years, much emphasis has been placed on the importance of patient-reported outcome measures (prom) in research investigating patients hospitalised in critical care [ ] . it is well established that oral health status is one of the determinants of quality of life [ ] . poor oral health has been shown to negatively impact quality of life across different populations [ ] [ ] [ ] [ ] [ ] [ ] . therefore, it is of concern that recent evidence suggests that hospitalisation is associated with deterioration in oral health as shown by increased plaque levels, gingival bleeding and xerostomia [ , ] . the decline in oral health during hospitalisation is of the utmost electronic supplementary material the online version of this article (https ://doi.org/ . /s - - - ) contains supplementary material, which is available to authorised users. importance: this population is more vulnerable to oral disease, this deterioration may potentially affect their quality of life and poor oral health may result in a greater risk of ventilator associated pneumonia (vap) as it is reported that vap-associated pathogens may translocate from the oral cavity into the lungs. when patients develop vap, this infection results in an increase of mortality, length of ccu stay and cost. a systematic review that included trials and patients concluded that "oral decontamination of mechanically ventilated adults using antiseptics is associated with a lower risk of ventilator associated pneumonia" indicating that fourteen patients would need to receive this intervention to prevent one case of vap [ ] . poor oral health might add an additional burden, affecting the patient's comfort and limiting the ability to eat and speak in these already compromised patients [ ] . therefore, deterioration of oral health in ccu patients might constitute a public health issue, as it could reduce quality of life, with evidence indicating that it also confers an increased risk for nosocomial infections [ ] . a major limiting factor to further research is the absence of a validated tool to measure oral health-related quality of life in ccu patients. commonly used generic ohqol questionnaires include a large number of questions which are irrelevant for the critically ill given their life circumstances, limiting their applicability in this setting. furthermore, these questionnaires take a long time to complete and are not feasible if the patients are frail and severely compromised, as it is the case in a ccu, because of the burden placed on patients and/or healthcare givers. therefore, the aim of this study was to develop and validate a suitable tool to assess the impact of critical care on oral health-related quality of life (ohqol) and to investigate patient-reported outcome measures of ohqol in patients hospitalised in a ccu. the study was conducted in accordance with the principles of the declaration of helsinki (ethical approval nres rec london -fulham, iras project id ). we followed a multi-stage approach similar to that described by guyatt and co-workers [ ] . the project included three phases: (a) initial tool development, (b) pilot study and (c) validation study; see fig. ( ) admitted to ccu for at least h ( ) received level two or level three care as described by the intensive care society standards ( ) able to communicate in english to the nurse/assessor (glasgow coma scale (gcs) of ; richmond agitation sedation scale (rass) score between and ) ( ) at least years of age conceptually, for the development of the questionnaire, we used the definition of ohqol from locker and allen: "the impact of oral disorders on aspects of everyday life that are important to patients and persons, with those impacts being of sufficient magnitude, whether in terms of severity, frequency or duration, to affect an individual's perception of their life overall" [ ] . a literature search was performed which ascertained that no research was available in relation to ohqol in ccu nor were there any validated tools to measure the ohqol of patients at a ccu. we reviewed the literature to identify the most common oral health problems experienced by those hospitalised in ccu. we mapped the items and domains obtained from the literature and sought advice from a panel of experts, including consultants and nurses in critical care and experts in oral care and public health, to compare them against existing ohqol tools validated in other settings. the domains and items were revised and re-presented to the expert panel until consensus was reached. the comprehension of each of the items was initially assessed using the question understanding aid tool (quaid) and items modified as required [ ] . as a result of this initial research, an initial ccu-ohqol tool was created (supplementary files-initial tool). the domain and item revision involved administering the tool in a pilot study involving ccu patients before discharge. the patients assessed the interpretability, relevance and acceptability of the ccu-ohqol. after the questionnaire was completed, the nurses conducted a short interview comprising a series of open-ended questions with regard to the validity of the domains and items of the questionnaire and to identify possibly missing items. the initial tool was modified as necessary. the final version of the ccu-ohqol tool (supplementary files-ccu-ohqol questionnaire) was administered to a larger sample, to assess construct validity, reliability and acceptability. as per the intended final use, the questionnaire was self-administered. there are no definitive criteria for the required sample size in a validation study of this kind. however, previous literature suggests that a sample size of to patients should be sufficient for the proposed analysis [ ] . content validity was assessed through the frequency of endorsement for each item amongst the patients included in the pilot study. for construct validity, the correlation between previously validated global ohqol items [ ] and the score for the items in our questionnaire was analysed using the non-parametric spearman's rank correlation coefficient. furthermore, associations between the ccu-ohqol overall score grouped in categories (i.e. good/fair/poor ohqol) and global ratings of ohrqol were tested using kruskal-wallis non-parametric test. the reliability of the tool was also assessed: internal consistency was measured using cronbach's alpha coefficient and by analysis of the item-total correlation and cronbach's alpha if item deleted. test-retest reliability was tested via intraclass correlation coefficients. differences in self-reported oral health before hospitalisation and at ccu discharge were assessed by wilcoxon signed rank tests. overall scores for the ccu-ohqol were calculated by summing up the response codes since ordinal values were coded for each question as presented in supplementary files-ccu-ohqol questionnaire. the distribution of the participants within categories ("good", "fair" or "poor" ohqol) was investigated as well as the distribution of responses for all individual items. we also assessed three summary variables: severity, prevalence and extent; in a similar fashion to that defined by slade and co-workers [ ] and modified to suit the characteristics of our questionnaire: • severity the sum of ordinal responses • prevalence the percentage of participants answering one or more item with ordinal values or . (i.e. "very bothered", "extremely bothered", "dissatisfied"strongest negative impacts) • extent the number of items per subject answered with ordinal values or the correlation between the global rating qol items, the self-reported oral health items and the score for the items in our questionnaire were analysed using the nonparametric spearman's rank correlation coefficient. the purpose of assessing these correlations was to explore the relationships between self-reported oral health, ohqol and qol overall. furthermore, the associations between self-reported changes in oral health during ccu stay and overall ccu-ohqol score were tested using one-way analysis of variance. analysis was carried out using spss statistics for windows (version . , ibm corp, ny). a total of and subjects were recruited for the pilot and validation study, respectively. the demographic characteristics of the study population for both parts b and c are presented in table . the expert panel agreed that the tool should include items for the following domains: "satisfaction with oral health", "functional limitations", "oral symptoms", "social impact", "self-care" and "psychological impact". subsequently, a pool of items was scrutinised until consensus was reached for a total of items to be included in the initial tool (supplementary files-initial tool, items to ). questions assessing self-reported oral health, three global ohqol items and a global qol item were also included. the analysis of the frequency of endorsement of each item revealed very few items left unanswered ( . %) and a good distribution of endorsement amongst the available responses for each item. in addition, "floor" and "ceiling" effects were not present when the questionnaire was analysed as a composite score. during the short interviews, . % (n = ) of the sample reported that the questions were relevant and participants ( . %) reported that the items related well or very well to their experience during their ccu stay. the addition of questions asking about tooth brushing frequency and bad breath was suggested by five subjects each. the recruitment rate was . % of all subjects asked to participate in the study. the mean time for questionnaire completion was min s (ci % min s- min s). the majority of the sample ( . %) thought that the time to complete the questionnaire was reasonable and they would do it again while reporting that the wording of the questions was good ( . %, n = ) and easy to understand ( . %, n = ). following data collection and analysis of the pilot study, the results were reviewed by the expert panel in critical care and oral health that contributed to the development of the initial tool. as a result, two items relating to bad breath and toothbrushing frequency were incorporated. the final tool was completed by ccu patients. the correlation coefficient between the ccu-ohqol score and the overall score of the global items of ohqol was . (p < . ). furthermore, the ccu-ohqol score was strongly or moderately correlated with all three global items individually (item : . , item : . and item : . ) being all also statistically significant (p < . ). there was an association between the categorised version of the ccu-ohqol tool and the mean rating of the global ohqol tool which was statistically significant (p < . : kruskal-wallis non-parametric test). similar associations and gradients were also observed with each of the global ohqol items when assessed individually (see fig. ). cronbach's alpha coefficient was . . all of the items of the ccu-ohqol tool showed an item-total correlation between . and . (supplementary files-item-total correlation) with the exception of questions ( . ) and question (− . ). these two questions were also the only items where their deletion resulted in an overall increase in cronbach's alpha (item : . ; item ( . ). test-retest reliability was assessed by asking a subset of the subjects (n = ) to complete the questionnaire twice, days apart. the mean intraclass correlation coefficients (iccs) for the scale overall was . ( % ci . - . ). a total of patients were approached to take part in part c of the study and participants were recruited, translating into a recruitment rate of . %. on average, the questionnaires took the participants min and s (ci % min s- min s) to complete. the dimensionality of the tool was assessed using principal component exploratory factor analysis (efa). we retained factors with eigenvalues > and rotated them with "varimax", which is an orthogonal rotation method. items were assigned to retain rotated factors when they had a loading of ≥ . in absolute value. the magnitude of factor loadings, distribution of variance amongst the factors, and the relative correlation of the items with the different factors were assessed. after varimax rotation, the first component explained % of the variance, and the second principal component added . % to the variance explained (see table ). the third, fourth, and fifth components had eigenvalues of . , . , and . , and explained variances were . %, . %, and . %, respectively. fourteen out of the items loaded highly on no more than one particular dimension (see table ). the four items in the first rotated principal component describe functional limitations and include four out of the five items which were included by our expert panel within this dimension and therefore maintained the name of the original dimension. items referring to psychosocial impacts (items and ) were found in the second factor only. in addition, this factor also included items and which were included in the oral symptoms dimension. item may well have been considered by patients as an indicator of a social interaction and this factor was therefore named "psychosocial impacts". the third dimension/factor included the two items measuring symptoms of dry mouth and was therefore named "xerostomia". the main item tapping into the th factor was question . the second highest factor loading (although just short of the cut-off . value) in this dimension was item , which was also the only other item with a factor loading above . for this component. since items and were the two items originally included in the dimension "self-care", this component retained this name. finally, the fourth factor referred to questions and . question was included as an item for "satisfaction with oral health" and seems unrelated to question ; therefore, it is difficult to discern to which specific dimension these items may be tapping and remained unnamed. table . in addition, nearly % of the participants (n = ) experienced negative impacts that bothered them at least "somewhat", . % reported that the negative impacts affected their life overall at least "somewhat" and . % had negative impacts that affected their quality of life at least "somewhat". those who reported a deterioration in self-reported oral health showed a higher mean ccu-ohqol score ( . , ci % . - . ) compared to those whose self-reported oral health did not change ( . , ci % . - . ) although this was not statistically significant (p = . ). the ccu-ohqol showed clear face and content validity. for construct validity, the tool achieved very strong correlations with global ohqol (p < . ) in the expected direction with higher ccu-ohqol scores indicating worse ohqol. furthermore, participants with a "poor ohqol" showed greater impacts in their overall life and quality of life. reliability was adequate with a cronbach's alpha of . , above the acceptable threshold of . [ ] , and adequate test-retest intraclass correlation coefficient of . ( % ci . - . ). therefore, these data suggest that the ccu-ohqol has appropriate characteristics to be used for the stated purpose. according to our results, hospitalisation in ccu has a negative effect on the self-perceived oral health of patients. more interestingly, those who reported a deterioration in self-perceived oral health, also showed a higher mean ccu-ohqol score (poorer ohqol). although the correlation marginally failed to show statistical significance (p = . ), there was a clear trend with nearly a twofold increase in the overall ccu-ohqol score which may have reached significance in a larger sample. this could be understood as initial evidence to suggest that changes in oral health after hospitalisation, as perceived by the patients, may indeed have an effect on their quality of life. we also obtained a cross-sectional view of the ohqol amongst the participants. we use estimates of prevalence, extent and severity as they provide important complimentary information when interpreting ohqol data [ ] . these estimates show significant impacts of oral health on quality of life in our sample. the impacts seem to be more prevalent and intense in the "functional limitations", "oral symptoms" and "self-care" domains and relatively more modest for "psychosocial impact". in addition, the overall qol items revealed that a significant proportion of the sample had impacts that affected their life overall. to date, there are no other studies exploring self-reported oral health and ohqol in the critically ill which precludes comparison of these results. the current results suggest a very strong impact of "xerostomia" in the ohqol of the critically ill. this is consistent with previous evidence reporting that intubated ccu patients have a significantly reduced salivary flow during hospitalisation [ ] . in addition, there are some studies suggesting a deterioration of ohqol in patients admitted to hospital outside ccus [ , ] . similar to our findings, hospitalisation resulted in worsening of oral health and low ohqol in other hospitalised populations [ ] [ ] [ ] . yu and co-workers showed that for chinese geriatric patients, the disruption of the normal daily living routine as a result of hospitalisation translated to a worsening of oral health and low ohqol [ ] . additionally, schimmel and co-workers compared the ohqol of hospitalised stroke patients who presented with hemi-facial and/or limb palsy at the university hospital of geneva (switzerland) to that of subjects with similar age, gender and dental status [ ] . the results also indicated a lower ohqol in the hospitalised population compared with the control group. the ohip-edent [ ] mean score was . ± . in the control group and . ± . in the hospitalised population (p = . ), with higher scores indicating lower ohqol. also in accordance with the previous studies, cornejo et al. [ ] in a cross-sectional study amongst institutionalised elderly in barcelona (spain) found that % of the participants had poor ohqol and this was associated with self-reported poor oral health. all in all, it seems that the decline of quality of life due to a worsening of the oral health might be more marked in unwell and hospitalised patients. extrapolating what we know about the impact of critical care on the hqol and the impact of poor oral health on the ohqol of medically compromised patients as discussed above in addition to the results of our study, it could be possible that some of the deterioration in hqol of the critically ill is due to changes in oral health. in order to improve patient care, we need to know what ohqol means to patients and what experiences they relate to their stay in ccu. experiences of critically ill patients are an important aspect of the quality of the care and are essential to guide bedside decisions in the ccu; they should be placed at the centre of public health debate. the strengths of the study include the systematic process followed to develop the tool tailored to our target population. the ccu-ohqol tool is "patient-centred and incorporates aspects of daily living that patients deem to be important" as the patients themselves were involved in the development of the tool [ ] . ideally, participants could have been involved earlier in the process via interviews at the stage of item generation to further limit the risk of critical items being overlooked. the aim was to develop a questionnaire that would not be burdensome on patients or staff to complete. the time for completion of the questionnaire was short and % of the patients reported they would be happy to repeat the questionnaire if needed. however, we recruited a relatively low number of subjects in the final phase of the project and the low recruitment rates may suggest some degree of selection bias; based on the data presented in table , the population in our study seems to be representative of the patients seen at the ccu at uch. forty-five patients are at the lower end of what would be considered acceptable [ ] . in addition, the sample size for test-retest analysis was also small, precluding meaningful interpretation. completion of the second questionnaire is logistically difficult since many patients may be discharged from the ccu to their homes or to other hospitals. in addition, in the initial development and validation of the tool we did not complete an oral examination to assess objectively the oral health of the participants but rather used a previously validated self-reported measure of oral health. further studies using the ccu-ohqol and including objective clinical assessments of the oral health of the participants would allow assessment of the responsiveness of the tool and also provide an opportunity to compare the questionnaire against other generic ohqol tools. finally, the cross-sectional analysis of the ohqol of the participants should be interpreted with caution since the study was designed with the primary aim of developing and validating the ccu-ohqol tool. without a control group, the changes might have been due to secular effects not related to ccu. it is not clear what the ideal control group should be. nonetheless, assessing the oral health and ohqol of patients admitted to other hospital wards or institutionalised in nursing homes might allow meaningful comparisons even if not representing a true control group [ , ] . it is also worth noting that it has been proposed that some of the changes in ohqol and qol may be due to psychological adjustments such as changes in expectations due to illness which may be particularly relevant in the ccu due to the "response shift" that patients hospitalised in critical care may suffer. further evaluation of the ccu-ohqol tool is needed to test its psychometric properties and its applicability in other ccu settings. future studies should provide information regarding test-retest stability and the ability of the tool to discriminate between groups with different levels of oral health assessed by traditional clinical measures. finally, the responsiveness of the questionnaire could be studied through administration as part of a randomised controlled trial [ ] . as perceived by the patients themselves, our results contribute to the body of evidence suggesting a deterioration in oral health following hospitalisation. more importantly, this deterioration was associated with poorer ohqol indicating that these changes may indeed have an impact in the life and well-being of those hospitalised in a ccu. since the care received at the ccu would ultimately influence the oral health of the critically ill, this is an extremely important finding encouraging the search of new interventions and care pathways to maintain oral health following admission to a ccu, being this an important public health matter. by including this ohqol tool in future research, influential data will be provided to decision makers for the development of health promotion and may help to identify a group of patients for whom new care pathways aimed at improving oral health are needed [ ] . simple ccu nurse-led interventions have already been shown to maintain oral health [ ] and therefore this is an achievable objective. ( ) this study is the first to develop a tool to measure ohqol in patients hospitalised in a ccu: the ccu-ohqol. the new tool has good acceptability, clear face, content and construct validity and satisfactory internal consistency reliability. ( ) for a large proportion of the patients, self-rated oral health deteriorated following hospitalisation in a ccu and this deterioration seems to be associated with poorer oral health-related quality of life. ( ) overall, there were substantial negative effects of oral health on the patient's quality of life during their stay at the ccu with a high prevalence, extent and severity of impacts in the patient's daily living and quality of life. quality of life after intensive care: a systematic review of the literature the concept of positive health: a review and commentary on its application in oral health research effect of arch length on the functional well-being of dentate adults impact of prosthodontic status on oral wellbeing: a cross-sectional cohort study key factors associated with oral health-related quality of life (ohrqol) in hong kong chinese adults with orofacial pain effects of severe dentoalveolar trauma on the qualityof-life of children and parents quality of life and psychological well-being among endodontic patients: a case-control study impact of oral health on the life quality of periodontal patients the impact of hospitalization on oral health: a systematic review the impact of hospitalization on dental plaque accumulation: an observational study oral decontamination for prevention of pneumonia in mechanically ventilated adults: systematic review and meta-analysis guidelines for oral health care for long-stay patients and residents measuring disease-specific quality of life in clinical trials what do measures of 'oral health-related quality of life' measure? quaid: a questionnaire evaluation aid for survey methodologists measuring functioning and well-being. the medical outcomes study approach to what extent do oral disorders compromise the quality of life? impacts of oral disorders in the united kingdom and australia health measurement scales: a practical guide to their development and use interpreting oral health-related quality of life data. community dentistry and oral epidemiology oral health status and development of ventilator-associated pneumonia: a descriptive study impact of oral health status on oral health-related quality of life in chinese hospitalised geriatric patients oral health-related quality of life in hospitalised stroke patients oral health-related quality of life in institutionalized elderly in barcelona (spain) developing short-form measures of oral health-related quality of life changes in dental plaque following hospitalisation in a critical care unit: an observational study measuring change over time: assessing the usefulness of evaluative instruments oral health-related quality of life: what, why, how, and future implications acknowledgements we thank dr jean e. suvan, deborah smyth, magda rocha, georgia bercades, jung hyun ryu, alicia san jose and alison macklin for their help for study coordination, recruitment and collection of data. this project was supported by researchers at the national institute for health research university college london hospitals biomedical research centre.open access this article is distributed under the terms of the creative commons attribution . international license (http://creat iveco mmons .org/licen ses/by/ . /), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the creative commons license, and indicate if changes were made. conflict of interest the authors declare no conflict of interest. ucl and/or uclh and uclh cbrc paid salaries as part of their research/ clinical roles to all authors and researchers involved in the project.ethical approval all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the helsinki declaration and its later amendments or comparable ethical standards (ethical approval nres rec london -fulham, iras project id ).informed consent informed consent was obtained from all individual participants included in the study. key: cord- -erigjz g authors: robertson, colin title: towards a geocomputational landscape epidemiology: surveillance, modelling, and interventions date: - - journal: geojournal doi: . /s - - - sha: doc_id: cord_uid: erigjz g the ability to explicitly represent infectious disease distributions and their risk factors over massive geographical and temporal scales has transformed how we investigate how environment impacts health. while landscape epidemiology studies have shed light on many aspects of disease distribution and risk differentials across geographies, new computational methods combined with new data sources such as citizen sensors, global spatial datasets, sensor networks, and growing availability and variety of satellite imagery offer opportunities for a more integrated approach to understanding these relationships. additionally, a large number of new modelling and mapping methods have been developed in recent years to support the adoption of these new tools. the complexity of this research context results in study-dependent solutions and prevents landscape approaches from deeper integration into operational models and tools. in this paper we consider three common research contexts for spatial epidemiology; surveillance, modelling to estimate a spatial risk distribution and the need for intervention, and evaluating interventions and improving healthcare. a framework is proposed and a categorization of existing methods is presented. a case study into leptospirosis in sri lanka provides a working example of how the different phases of the framework relate to real research problems. the new framework for geocomputational landscape epidemiology encompasses four key phases: characterizing assemblages, characterizing functions, mapping interdependencies, and examining outcomes. results from sri lanka provide evidence that the framework provides a useful way to structure and interpret analyses. the framework reported here is a new way to structure existing methods and tools of geocomputation that are increasingly relevant to researchers working on spatially explicit disease-landscape studies. while the global burden of disease has been shifting from communicable to non-communicable diseases and injuries (murray et al. ) , infectious diseases continue to causes persistent (hiv/aids; tuberculosis; malaria), and episodic (ebola in west africa) public health threats. in both cases, the environment is critical to the risks to human health and wellness posed by infectious agents (lash et al. ; weiss and mcmichael ) , environmental toxins (ard ) , access to healthcare (wang and luo ; kwan ), social disadvantage (wilkinson ) , and stress (shankardass ) . there is a pressing need to develop the theories, tools and datasets that support investigating links between the environment and health. a number of converging trends are currently aiming towards a greater role for geography in studies of environment and human health. firstly, the emergence and re-emergence of infectious pathogens over the last few decades has re-emphasized the importance of local exposures and risks, whether due to environmental or communicable transmission processes that result from complex assemblages of local and globalscale processes. secondly, spatially explicit models of infectious diseases have been developed at a range of spatial and temporal scales-from household-level models of infectious disease spread (riley ) , to global models of the factors driving the spatial distribution of zoonotic pathogens (jones et al. ) . these models require spatial datasets describing every aspect of disease risk from wind patterns to health-seeking behaviours. the use of geographic information systems (gis) is critical to the building and operation of spatially explicit disease risk models. finally, spatial modelling has been improved by the concurrent rise in sources of geographical data to support such modelling efforts across all scales (though not all diseases). the importance of the 'landscape' in emerging, zoonotic, and infectious disease literatures is widely recognized from both a substantive perspective due to greater interdependencies between populations (khan et al. ), incursion into natural areas (e.g., field et al. ) , intensification of livestock production (gerber et al. ; graham et al. ) , wildlife trade (karesh et al. ) as well as more practical considerations due to the abundant data and technologies now available (e.g., vitolo et al. ) . we focus on landscape epidemiology (le) which is interested in the interaction between features of the landscape (and their composition and configuration) with disease and risks of disease. this is distinct from the broader domain of spatial epidemiology, which includes studies of health services and health systems. despite the growing adoption of geographic tools and methodologies, their deployment in infectious disease epidemiology, modelling, and control at the implementation level has been mostly piecemeal and study-specific. lambin et al. ( ) suggested ten propositions which help to situate relationships between landscape change and infection risk, identifying key themes such as connectivity, landscape configuration and composition, the importance of examining processes and patterns at multiple spatial and temporal scales, and human behaviours. while these propositions provide a valuable guide for researchers, they do not provide aid to the use of that knowledge in applied settings. most research into landscape and disease risks assume a better understanding of infection risk will ultimately 'trickle down' to effective uses of that enhanced knowledge. recent advances in understanding of how knowledge is adopted in decision-support contexts, and the translation of knowledge to specific communities of users in application of health research and technologies has shed light on the importance of the types of knowledge and expertise required to make this transaction possible (straus et al. ) . the simple fact that knowledge exists does not necessarily mean that it will be pushed to development and application (estabrooks et al. ) . in this paper we take a different approach, by focusing on three core knowledge use contexts that broadly encompass the majority of spatial epidemiological studies. we aim to develop a single organizational framework for conducting studies of landscape and infectious diseases that situate methods and data within the broader conceptual context and thereby promote more rigorous and transparent study design and interpretation and translation of findings. need for organizing framework for landscape approaches to health the rapid expansion of methods and data available for landscape-oriented epidemiological studies has considerably transformed health-environment research over the last two decades. it is now customary to include landuse/landcover data sensed from satellites, climate data obtained from global repositories of networked weather stations (e.g., worldclim) or from satellite sensors such as the tropical rainfall monitoring mission that provides daily rainfall data for all of asia. also, these data products are increasingly available at a global scale, and as 'pre-processed' information products consumable by spatial models. for example, the worldpop project (http://www. worldpop.org.uk/) aims to provide high-resolution spatially explicit demographic data across south and central americas, asia, and africa (tatem ) . geographically granular case data aggregated over small health areas are also commonplace, both in studies in the developed and developing worlds. data describing other features of the environment such as roads, river networks, water bodies, built-up areas, health care service locations are also increasingly available in even remote parts of the world. we are on the cusp of real-time global-scale epidemiology, whereby 'feeds' describing the important features of the environment for health is updated in real-time. for diseases with immediate environmental components of risk (e.g., arboviruses, heat-related illnesses), the benefits of timely updating of spatially explicit information on risk factors provide opportunities for highly granular public health responses and data-driven policy formulations. further, diseases with longer latencies and more complex risk profiles also stand to benefit from enhanced environmental information. with this data-rich environment in machine-readable forms, and the capacity for automated model-building, it is important to structure analysis using such large, spatially explicit information sources within a broader framework for understanding disease-landscape dynamics (e.g., lambin et al. ) . citizen-based, user-generated, or volunteered data have also become increasingly prevalent, sometimes described as participatory epidemiology (brownstein et al. ). the recent cholera outbreak in haiti provides a salient example, where volunteers on the ground and on the other side of the world contributed data and expertise to the mapping of local environment in support of disease control and health programs. citizen-generated data is also increasingly used in empirical studies themselves, for example-actively in mobile health-reporting apps such as 'outbreaks near me' (freifeld et al. ) as well as passively, when web-search data are repurposed for syndromic surveillance of seasonal influenza (hulth et al. ), in support of what is often called 'epidemiological intelligence'. in landscape epidemiological research, all of these datasets can be accessed, mapped, and integrated via their geographies to derive factors affecting disease risk, and the cumulative risk distribution in space and time. the data processing methods, software, statistical tools, visualization approaches, and reporting mechanisms that drive this research vary considerably, and encompass a wide array of levels and areas of expertise. as such, the place of geocomputation-the tools and methodologies of geographic computing-within this spectrum of approaches is unclear, and more importantly, selecting the appropriate approach for a given study objective is increasingly difficult. reviews of 'gis in epidemiology' have not provided this sort of framework. many reviews have rightly focused on broad overviews of spatial analysis or gis methods and disease (cromley ; rytkönen ) , and/or their application to areas such as animal disease (freier et al. ) , and other areas such as surveillance (robertson et al. ) . the shortcomings of gis approaches to health research and specifically the disconnect between analytical methods and parameters such as neighbourhood weights matrices in disease mapping models, and their epidemiological meaning was highlighted by yang et al. ( ) , whereas fritz et al. ( ) review and compare methods for handling point event data in spatial health research. barrett et al. ( ) reviewed the scope for big data to improve understanding and tracking of health-related behaviours and outcomes. and while the emphasis in health geography over the last two decades has focused largely on social determinants (kearns ; kearns and moon ) , these approaches have bifurcated somewhat from approaches dominant in spatially oriented infectious disease epidemiology, which have remained quantitative and modelling/biomedically oriented. rather than debate the relative merits of these paradigms, it is instructive to re-examine the motivation for these studies in the first place, and perhaps contextualize these differing research frames within a common framework. recent work relating infectious disease risk to climate change has introduced ideas from adaptation research such as vulnerability and adaptive capacity that are conditioned on socioeconomic processes (kienberger and hagenlocher ) is an example of a new generation of integrative spatial studies of health and disease that may be bridging this gap. in this paper, we present a framework oriented around knowledge uses and existing tools in order to provide a methodological grounding for new integrative studies in landscape epidemiology (le). a key requirement for landscape epidemiology is the ability to handle, process, represent, and transform large amounts of data. the backbone of gisrelational database management systems-has provided the technology for this historically, although geojournal ( ) : - rarely identified explicitly in research related to le studies. however, given the increasingly granularity of satellite data, the volume of mobile sensor data, and the advent of 'big data' generally (and real-time epidemiology), these technologies are starting to become insufficient to handle the current data-rich environment. new geocomputational methods for spatial data storage and access may be required for new research in landscape epidemiology-including spatial indexes, data compression algorithms, and knowledge discovery algorithms. for example, social media data streams are by definition 'always on'-and extracting and storing a subset of these defined by space and time into a relational database for the purposes of on-line surveillance of new disease reports induces a delay in the processing chain. application programming interfaces (apis) as a way of accessing data portals algorithmically partially sidestep this issue, but these tools are by their nature reserved for researchers with advanced technical skills. consequently, the 'data processing step' is an increasingly relevant but frequently overlooked component of le studies, as data integration based on geography is often required prior to undertaking any analysis. complex processing chains that incorporate web-based geographic data repositories, cloud-based storage and analysis, and delivery of results via web-map services may encompass the computational tools of neogeography (e.g., openlayers, cartodb, d , leaflet), open data portals and cloud services (e.g., amazon ec ) and a myriad other software tools and packages. situating these methods and tools within their functional context relevant for le will provide an organizational mapping to aid understanding of this complex and rapidly evolving landscape. a key theme in the adaptation of landscape approaches to human health is the explicit recognition of the importance of multiple spatial and temporal scales in the study of health outcomes. while scale has increasingly been emphasized in the health geography literatures, much of this work has been conceptual and theoretical rather than applied. while laying the necessary theoretical foundations for a multi-scale approach to understanding health and disease in populations is an important first step, concrete tools and methodologies are required in order to operationalize these ideas for applied le. geocomputational methods are well-suited to multi-scale analysis, however there are several approaches to multi-scale analysis that can be taken, and little guidance is available to researchers aiming to take a multi-scale approach to le. characterizing features of the landscape at multiple scales is perhaps one of the most widely employed tactics, whether it is compositional factors (e.g., percent forest cover) or configurational properties (e.g., edge density, fragmentation). identifying 'zones' of scale consistency and abrupt changes in landscape properties with scale can provide insight into the appropriate spatial scale of investigation (wu ). this approach is consistent with the landscape ecology paradigm of hierarchical patch dynamics, which may provide a conceptual basis for investigating landscape influences on health in patchy landscapes. the theories, tools and data driving applied le research today have significant potential to improve health of individuals and the allocation of scarce healthcare resources. our aim in proposing the framework that follows is to more clearly organize current methods, provide a structure for research design, and more concretely link methods to knowledge translation and use. surveillance can provide health workers with the baseline knowledge required to judge when and where unusual events are taking place, which can catalyze early responses to outbreaks or changes in disease incidence. knowledge of risk factors can contribute to formulating effective interventions, and identifying areas and populations vulnerable to disease. once knowledge of landscape influences on health and disease is established, this can be applied and integrated into healthcare delivery systems in contextually appropriate ways (lai et al. ). we provide the motivation for our framework through the lens of applied le. while these use-cases are not encompassing of all studies that might employ le approaches, these categories cover the majority of applied research objectives, and as such will provide a useful lens through which to contextualize our organization of geocomputational methods applicable for le. it is worth highlighting that these categories are not mutually exclusive, and often studies and research projects aiming to take a le approach will encompass two or even three of the use-cases. surveillance: what has changed? public health surveillance is defined by the world health organization (who) as continuous, systematic collection, analysis and interpretation of healthrelated data needed for the planning, implementation, and evaluation of public health practice (who ) . a variety of objectives may drive surveillance including outbreak detection, situational awareness, and identifying long term trends, and statistical and computational methods will be specific to the system objective (robertson et al. ). additionally, a variety of information sources may be required to achieve a given public health objective targeted through surveillance (who ). the inclusion of explicit geographical information is now a key component of most actionable public health surveillance systems, including those focused on infections with major landscape components. spatial risk modelling: why are things are where they are? many spatial-epidemiological studies are interested in identifying the factors that contribute to the spatial risk distribution. most regression-type models employed through either generalized linear modelling framework or bayesian hierarchical modelling fall into this category. with respect to landscape risks, a wide variety of modelling methods are now being used such as maxent (phillips et al. ) , random forests (and related methods) (breiman et al. ) , and general additive models employing various nonlinear mappings (hastie and tibshirani ) . the elucidation of spatial risk factors in le can provide key insight into how landscape impacts risk, but often these connections are difficult to identify and confounded with sampling unit and spatial scale (e.g., modifiable areal unit problem). evaluating disease control methods has been largely the domain of mathematical modelling methods that have been developed for outbreaks of infectious diseases, and environmental heterogeneities are rarely included-often because spatially explicit data are lacking and/or relationship to environmental factors are unknown (although see a recent example of the ebola outbreak by merler et al. ) . however policy-scenario modelling in the context of disease control can be used to investigate the effect of different public health policies on health outcomes of interest (e.g., claude et al. ). the required knowledge in order to parameterize models for evaluating interventions is generally very extensive and requires understanding some degree of absolute risk (e.g., lengeler et al. ) . here we propose a functional framework for organizing analytical tasks that are commonly employed as part of le, which we are terming geocomputational landscape epidemiology (gle). geocomputation was defined in openshaw ( ) as the 'application of a computational science paradigm to study a wide range of problems in geographical and earth systems (the geo) contexts'. this definition makes special point to emphasize that the geo includes both human and physical systems, and that geocomputation is part of a wider shift towards computational science in social sciences, natural sciences, and subfields of the humanities disciplines that emphasizes mathematical models, simulation, and high-performance computing. geocomputation is not equivalent to data mining, machine learning, or computer science, but may include aspects of these disciplines (couclelis ) . the defining characteristic of geocomputation is that advanced computational tools and methods are deployed for solving complex geographical problems that would otherwise not be possible. thus the tools in geocomputation do not only provide a faster way of doing calculations, they provide a methodology for conceptualizing new research questions from a computational science perspective, and the tools to answer these questions. geocomputation may be seen as analogous or congruous to the computational science approach to social science generally, described by torrens ( ) as ''making use of computing and informatics in exploring the mechanisms that drive complex social, behavioral, and economic systems'', emphasizing themes of complexity, modelling and simulation, visualization, cyberspaces, semantics, and socio-technical systems. in the natural sciences, advanced computational methods have been deployed for modelling and simulating environmental processes for many years, often as implementations of numerical models. there is a natural fit to apply the tools of geocomputation to landscape epidemiology, which was described originally by pavlovksy ( ) as the concept of the 'natural nidality of human diseases', recognizing that the sources of human disease existed naturally in the environment, varying with climate, soils, elevation, vegetation, and other landscape components. these ideas, most evident for the zoonotic infections for which they were discovered, have also been extended to chronic disease, and recognition of environmental effects on health is now widespread. recent adaptations and extensions have been formulated as ecosystem-health, which focuses on health from an ecological perspective (waltner-toews et al. ) , one health, which emphasizes inter-relatedness of animal and human health (coker et al. ) , and wildlife health (grogan et al. ; stephen ) , which takes a similar approach to the protection and promotion of healthy wildlife populations. we present this framework as a general organizing system for studying disease from an explicitly 'landscape' approach, one which by its nature requires some sophistication in spatial analysis and geographic information handling methodology. more importantly, the framework provided in fig. outlines a knowledge-based organization of geocomputational methods. characterize the assemblage the first component of gle is called 'characterizing the assemblage' and encompasses all methods of analysis that aim to describe a pattern or relationship. this phase usually comes before other phases and often will be the aim of study itself, such as to estimate a realistic distribution of disease risk from aggregated case data. there are two basic approaches to characterizing assemblages, which correspond to the two types of properties associated with a spatial pattern: pattern composition, and pattern configuration. pattern composition includes measures that describe how much of a quantity is distributed on the map, or broadly answer the question 'what is where?' we keep this definition broad as many of the approaches used in geocomputational approaches to le are aimed at answering these types of questions. for example, cluster detection and hotspot mapping methods are examples of this, which might not normally be described as measures of composition. measures of configuration-alternatively, seek to describe the spatial configuration of quantities on the landscape. configurational measures answer the question 'how is x configured on the landscape?'. answers to these types of questions are therefore descriptions of spatial pattern, rather than locations. details about the methods within this part of the framework can be found in table . measures of composition in this context comprise all methods that aim to describe or characterize the spatial or temporal distribution of risks and/or risk factors. as this is an extremely common and broadly defined task, this encompasses many different statistical approaches, but all aim to quantify or explain the distribution. measures of configuration contrast with those of composition as they are aimed at quantifying the spatial configuration of the pattern. the methods here are used to complement compositional measures as part of a gle study, and often have direct epidemiological relevance and can be used as covariates with modelling methods. characterizing functions of a system or disease of interest with geocomputational methods differs from the above as the focus here is on dynamic elements of quantities of interest. many of the methods and approaches noted in this section are more general than geocomputation alone, but do have important or special considerations when implemented in a setting where space is explicit. functional properties include describing inputs, outputs, and connections between different functions that might combine to form a complex system. as the ideas here are very general, we have broken up the concepts into some classes, though emphasize they area all descriptive of functional characteristics, and in most cases, require that basic characterization of the underlying landscapedisease assemblage has already been done. flows: activity patterns, trade flows, animal movement, vector movement many concepts relevant for describing health in le are better described as 'flows' then factors or static measurements of landscape properties. in our framework, flows can be defined as methods, variables, and concepts that describe movement of a quantity of interest in geographic and/or parameter space. in practice, this step of analysis might be used to develop spatial variables that are used in a study aimed at the 'characterize the assemblage' step, or may be the fig. framework for geocomputational landscape epidemiology which moves from lower level complexity of a describing patterns, b describing processes that interact with those patterns, c examining how patterns and processes contribute to disease risk and healthpromoting factors, and d evaluating final information products (maps or other) and link these to research gaps and knowledge uses geojournal ( ) : - objective of analysis. examples of flows include the movement of mosquito vectors with climate change, movement of cattle to markets in a region, commuting patterns of residents of a large metropolitan area, and the flow of capital into resource extraction industries in individual countries or regions. while we don't constrain our description to physical flows (e.g., diurnal movement of people within the city), we emphasize aspects of flows that can be represented and or analyzed within a geocomputational framework. often, non-geographic flows have important properties and expressions that are embedded within geographic space. for example, the use of social network analysis in recent years has increased-in order to identify physical contact tracing and exposure/transmission opportunities, but also to model the flow of knowledge about public health-related factors such as health-promoting activities or risk perceptions within and between vulnerable communities. in complex systems, feedbacks are defined as those components of a system that engage in or foster learning and exhibit behavior. in geocomputation, learning and behavior are increasingly relevant concepts, as algorithms are developed that learn relationships across space from continuous data streams (young ). many of the dynamical models of mathematical modelling center on feedbacks between system components, and estimation of critical epidemiological parameters. while geography has traditionally been excluded or assumed away in these models, the field of spatial statistics has developed spatially explicit extensions to classical epidemiological models (riley et al. ) . however, for le the majority of approaches that are focused on representing connectivity and positive and negative feedback between system components fall into the category of conceptual modelling approaches rather than empirical/mathematical modelling. the translation of conceptual models of complex systems to workable mathematical models that can be fit to observational data is one of the most challenging aspects of gle. in practice, there is often iteration between the approaches described in tables and and those in table . feedbacks can also exist within complex systems designed to represent a health domain that are identifying high risk areas kulldorff and nagarwalla ( ) , getis and ord ( ) and anselin ( ) gravity models effect of commuting patterns on spread of an infectious disease haynes and fotheringham ( ) and balcan et al. ( ) glm in r/spss etc. bishop ( ) and gahegan ( ) programming/applicationspecific geojournal ( ) : - created as loosely coupled ensembles of simple models-which are integrated with an aim of intelligence, situational awareness, or monitoring. events in the context of gle are discrete in space and time, and have relevance for understanding how landscape influences disease dynamics. the international health regulations ( ) define an event as ''a manifestation of disease or an occurrence that creates a potential for disease'' (ihr ) . this includes infectious disease, zoonotic disease, toxic pollution events, and these threats to public health form the basis for the 'event-based surveillance' approach described as part of who's early warning and response system (who ) . events in gle therefore correspond to methods and tools that are required for the handling, processing, and analysis of information sources that provide context or early-warning for occurrences that create potential for landscape-oriented disease (see table ). while the 'phases' above have focused on a categorization of existing methods used in geocomputational approaches to le, we now turn to a phase where the functions described in part are mapped back onto the compositional and configurational patterns described in part . here, we begin to see how interacting components of the system are spatially structured, which functional components share geographic properties, and what the overall controlling contribution of landscape is to the risk profile of interest. this might be considered an integrative or meta-analysis step as this is rarely done within the context of a single study, but generally is part of a review study or systemsbased empirical analysis of existing literature. there are few formal methods available for this step, but these types of meta-analyses or systems analysis are typically depended on when major new health events such as the emergence of a new disease occurs, as they provide a holistic description of the processes that conspired to lead to the event. a good example is provided by wang and eaton ( ) which describes the overall conditions that led to the emergence of sars in southeast china in including documented human-to-human spread, independent transmission events from animal-to-human in four separate cases, and animal-to-animal transmission among palm civet cats in a market environment. an example of a technological approach to this step might be that of healthmap which provides integration of reported health events obtained from the web from all over the world (brownstein et al. ) . through scraping, geocoding, and mapping health event data in a common platform, this platform provides the capacity for 'epidemic intelligence'using space to index health events and draw common cause and connections where they otherwise might not be apparent. this also provides multi-scale exploration of the patterns of outbreaks, from the local to international. the final part of this framework is to examine the outcomes, real or simulated, from the geocomputa- na tional representation of the disease/landscape system of interest. the task of examining the outputs of a model can include visual analysis, pattern comparison measures and sensitivity analyses to changes in model parameters. additionally, this sort of integrated interpretation also considers the advances made in the nonlandscape aspects of the disease that have taken place and may provide alternate (re)-interpretations of patterns. for example, when a new disease emerges, patterns of spread and distribution will be unexplained until the natural reservoir has been isolated and genetic work completed. the objective of this level of analysis is to realize integrated insight into landscape-disease interactions and risk. what follows is a brief case study that highlights the components of the framework in relation to a zoonotic disease of global importance, leptospirosis (bharti et al. ) . the case study is not exhaustive of the framework phases, and includes a review of previously published work and new analysis of a large outbreak in in sri lanka. leptospirosis is a one of the most prevalent zoonoses in the world, affecting millions of people annually every year. the bacterial spirochaete (i.e., leptospira) that gives rise to the disease in humans have a large number of animal reservoirs, including cattle, rodents and foxes. the bacteria are passed from animal reservoirs to the environment through urine-where they can then infect humans. in sri lanka, leptospirosis is historically associated with rice agriculture. transmission occurs when open wounds or skin abrasions come into contact with urine from infected rodents (giving rise to the local name 'rat fever'). diagnostic facilities are limited and the clinical presentation is similar to hantavirus infections (gamage et al. ; sunil-chandra et al. ) , and only a fraction of suspected cases are tested. a large outbreak of suspected leptospirosis occurred in sri lanka in . the reasons for the outbreak remain speculative, but are hypothesized to be at least partially due to expanded cultivation of paddy field areas that resulted from policies aimed at increasing domestic rice production. as part of the programme 'api vavamu, rata nagamu', unused fertile lands were targeted for food production among landholders, many which had not traditionally been involved in farming. the development of this program was a direct response to the global rise in food prices that began accelerating in , with international price of rice increasing % between (kelegama . according to the central bank of sri lanka, rice paddy production increased . % between and (kelegama ) . there are many questions related to the causes of the epidemic of notified cases of leptospirosis in sri lanka in to be investigated, including (a) whether cases truly were leptospirosis or a concurrent outbreak of some other clinically indistinct outbreak as has been theorized (agampodi et al. ); whether the epidemic had strong environmental determinantseither in higher than average rainfall, flooding, or other factors, and whether the epidemic was predictable and (c) what early warning could have been forecast using available data; (d) would the epidemic have happened had the local food production policy not been in place, and finally-(e) what was the importance of variability in clinical suspicion in driving the spike in reported cases. many of these questions have geographical dimensions that warrant and/or necessitate a geocomputational approach. employing the framework outlined in this paper as a guide, we will show how we could approach some of these research questions. starting with part -in many studies where a gle approach is employed, variables related to local meteorology and lu/lc will be the first step towards characterizing the assemblage of relevance for understanding the disease distribution. in many developing countries, these variables exist but are difficult to access or not available directly in digital form, and researchers often rely on long-term normals. depending on the application, these may be suitable candidates, but for most applications and gle contexts daily meteorological observations are required (or a combination of daily and normal)-a step that can require extensive text parsing to transform the data into a format suitable for storage in a geographic database. note that an important precursor to this step is to identify the spatial and temporal scales that are relevant for the study. the key questions we will explore in this analysis relate to the relationship between rainfall and reported cases of leptospirosis during the peak of the epidemic in . as disease reporting occurs over the administrative units scribed for the ministry of health, called medical officer of health (moh) areas in sri lanka, we need to standardize both measures over these geographical units. the potential mechanistic relationships include at least those outlined in table so the actual temporal lag required to investigate the relationship between cases is a key parameter of interest, as this could be used to determine the earlywarning value of rainfall modelling. in order to transform daily rainfall records obtained from the department of meteorology into seamless rainfall maps for the entire country, spatial interpolation modelling was performed. previous comparative analysis of interpolation methods found that thin-plate smoothing splines were a generally effective method for interpolating rainfall in sri lanka (plouffe et al. ) . daily rainfall records were tabulated into monthly totals for each of the stations, and each month was interpolated using tps function in the fields package in r (nychka et al. ) . averaging interpolated total rainfall for each month over each moh area provided concurrent estimates of rainfall and reported cases of leptospirosis over equivalent geographical units. surveillance data for weekly reported cases of leptospirosis by moh area were aggregated by year, and standardized by population to produce estimates of incidence per , for the year in each geographical unit. plots of the time series of annual cases and the monthly rainfall maps were compared visually. simple cross-correlation analysis between case counts and rainfall was used to identify potential temporal lags of importance for early-warning. the monthly time series of cases reveals a large spike in cases in september (fig. ) . the timing of this spike is consistent with peaks in cases in previous years, however the magnitude is much greater and worthy of further investigation. examining the rainfall patterns over evident in fig. , the most striking pattern is the unseasonably intense and extensive rainfall that occurred in march . whether this unusually high amount of rainfall occurred was related to the spike in reported cases on leptospirosis is unclear. correlation analysis revealed both positive and negative associations between incidence and rainfall ( table ) . the highest rank monthly correlations in terms of t-statistic magnitude were july (positive), march (negative), and april (positive). the magnitudes of the correlations were not high; indicating limited predictive potential at least at the scales investigated here. direct comparison of month-tomonth correlations would provide a more robust indicator of the relationship-however power is also reduced due to the smaller numbers and smaller effect sizes. month-to-month cross correlations indicated both positive and negative associations (fig. ) . while some interesting spatial patterns emerge from this analysis, the evidence is insufficient to explain the outbreak in , as key information is missing. note that our previous modelling work of landscape factors related to clusters of high risk found associations between paddy areas, small agricultural holdings, distance to cities and distance to rivers (robertson et al. ). with a basic description of the reported leptospirosis surveillance data now in place, we can move to use this example to motivate additional analyses within the gle framework that would improve our understanding of the dynamics of risk and the causes of the outbreak. the analyses reported in the section above indicated some evidence for a relationship driving at least the endemic cycle of cases, an anomalous event in september which does not have an obvious rainfall signal, and evidence of spatial variability in the relationships, suggesting perhaps both rural agriculture risk profile and a periurban risk profile combining to produce the risk landscape in . a functional analyses would examine the flows, feedbacks, and events that would describe the movement of people, their interaction with the health care system and care-seeking behaviours, application of control mechanisms, distributions of animal reservoirs and their habitats or production chains in the case of livestock, and individual interactions with paddy fields. as these forms of data are much more difficult to obtain than those used in the previous section, a dynamic modelling approach using individual-based models would allow for exploration of the parameter space in a way that we could test alternate scenarios that might lead to the observed pattern. we may also investigate specific events that occurred in september that may explain the spike in reported cases. for example, the year saw heavy fighting as the sri lankan army engaged in an offensive military push to end the civil war with the tamil tigers (ltte) that controlled much of the territory in the north of the country. in early september, the sri lankan army captured the town of mallavi that served as an administrative centre for the ltte. further study could investigate the impact of these events on disease risk and disease reporting. examining the surveillance data, the largest number of reported cases in september was reported from the homagama area; part of the colombo district in western province. this represents a % increase over the next highest reported month in this district, which otherwise follows expected seasonal dynamics. the cause(s) of this spike remains to be investigated, and could range from a simple data entry error, misdiagnoses, to linkages with the activities associated with the end of civil conflict in the north. looking at the weekly surveillance data, the fact that these cases were relatively evenly distributed across the weeks suggest a disease-causing event did occur during this time frame. in order to obtain system-level inferences on the leptospirosis-landscape system being investigated here, several additional studies would be required. we would suggest that these 'higher-level' inferences tend to be qualitative in nature, collaborative in their genesis, and built from shared interpretations of the more quantitative approaches to analyses described earlier. this aspect of analyses, though rarely formally articulated, should constitute a significant step in gle, especially given the highly multi and interdisciplinary nature of team-based research projects including ecologists, biologists, veterinarians, geographers, and social scientists. knowledge translation activities that include workshops, videos, tutorials, and others that optimally translate scientific knowledge to user-communities and knowledge-users is a critical integrative step for realizing 'decision-support' capacity of advanced spatial and statistical modelling efforts. we have presented a framework for gle that provides a categorization of methods commonly used to investigate landscape-disease interactions, can be used to design and frame future studies, and to provide a functional mapping between knowledge uses and methods. the framework is general and extendable, and will situate stronger research design for spatially focused projects in le. 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epidemiological transition: from material scarcity to social disadvantage? early detection, assessment and response to acute public health events: implementation of early warning and response with a focus on event-based surveillance effects of changing scale on landscape pattern analysis: scaling relations spatializing health research: what we know and where we are heading landscape epidemiology and machine learning: a geospatial approach to modeling west nile virus risk in the united states acknowledgments the authors gratefully acknowledge the epidemiological unit of the ministry of health, government of sri lanka, for providing access to the leptospirosis surveillance data used in this paper. conflict of interest none.research involving human participants and/or animals no humans were involved in this research.informed consent no human participants were involved in this study. key: cord- - gzi fo authors: davies, jane; bukulatjpi, sarah; sharma, suresh; davis, joshua; johnston, vanessa title: “only your blood can tell the story” – a qualitative research study using semi- structured interviews to explore the hepatitis b related knowledge, perceptions and experiences of remote dwelling indigenous australians and their health care providers in northern australia date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: gzi fo background: hepatitis b is endemic in the indigenous communities of the northern territory of australia and significantly contributes to liver-related morbidity and mortality. it is recognised that low health literacy levels, different worldviews and english as a second language all contribute to the difficulties health workers often have in explaining biomedical health concepts, relevant to hepatitis b infection, to patients. the aim of this research project was to explore the knowledge, perceptions and experiences of remote dwelling indigenous adults and their health care providers relating to hepatitis b infection with a view to using this as the evidence base to develop a culturally appropriate educational tool. methods: the impetus for this project came from health clinic staff at a remote community in arnhem land in the northern territory, in partnership with a visiting specialist liver clinic from the royal darwin hospital. participants were clinic patients with hepatitis b (n = ), community members (n = ) and key informants (n = ); were indigenous individuals. a participatory action research project design was used with purposive sampling to identify participants. semi-structured interviews were undertaken to explore: current understanding of hepatitis b, desire for knowledge, and perspectives on how people could acquire the information needed. all individuals were offered the use of an interpreter. the data were examined using deductive and inductive thematic analysis. results: low levels of biomedical knowledge about hepatitis b, negative perceptions of hepatitis b, communication (particularly language) and culture were the major themes that emerged from the data. accurate concepts grounded in indigenous culture such as “only your blood can tell the story” were present but accompanied by a feeling of disempowerment due to perceived lack of “medical” understanding, and informed partnerships between caregiver and patient. culturally appropriate discussions in a patient’s first language using visual aids were identified as vital to improving communication. conclusions: having an educational tool in indigenous patient’s first language is crucial in developing treatment partnerships for indigenous patients with hepatitis b. using a culturally appropriate worldview as the foundation for development should help to reduce disempowerment and improve health literacy. significant health disparities exist between indigenous and non-indigenous australians resulting in a [ ] [ ] year average reduction in life expectancy for an indigenous child born between and [ ] . liver disease is the third largest contributor ( %) to this gap in life expectancy with chronic hepatitis b (chb) contributing significantly, in the form of liver cirrhosis and hepatocellular carcinoma (hcc). chb is endemic in the indigenous communities of the northern territory (nt) of australia with prevalence rates estimated to be between . % [for children born in the universal vaccine era ( onwards)] and . % (for adults born pre universal vaccination) [ ] [ ] [ ] [ ] [ ] [ ] [ ] , this is compared to % in australia as a whole [ ] . despite the availability of effective, government subsidised treatments only an estimated % [ ] of all people living with chb in australia are receiving appropriate management for their infection. this disparity in rates of hepatitis b and low uptake of treatment is also seen in other indigenous populations across the world [ , ] . the barriers to people accessing care for chb are multifactorial but among indigenous australians, include gaps in knowledge, low health literacy and challenges in accessing the appropriate care [ ] . both a recent situational analysis [ ] and a qualitative study [ ] in the torres strait region of australia identified low levels of knowledge about chb both in health care providers and indigenous australian patients with chb. christie et al. [ ] have explored views of health literacy in the particular cultural context of remote indigenous communities in the nt, as well as carrying out a scoping study looking at ways to improve health literacy in this region. suggests that "effective health literacy is largely to do with effective communication" (p. ). based on their research, they argue that building on an individual's existing knowledge using a culturally appropriate approach (i.e. a relevant respectful partnership which is mindful of language, worldview, existing knowledge and beliefs) to achieve a shared understanding of the issue at hand is more beneficial than attempts by health practitioners to simply 'transfer' biomedical knowledge to their patients [ ] . although many health promotion or information resources exist for hepatitis b [ ] , all the above [ ] [ ] [ ] [ ] [ ] studies as well as the australian national hepatitis b strategy [ ] highlight the lack of culturally appropriate resources, in particular visual and multimedia resources, available to facilitate shared understandings of hepatitis b and strengthen health literacy. in the context of the nt indigenous population, english is usually a second (or even third or fourth) language; therefore, achieving effective cross cultural or "culturally safe" communication can be challenging, as has been extensively documented in health care settings over the last decade [ ] [ ] [ ] . miscommunication between health providers and patients has been reported to be pervasive, however using interpreters and translators is perceived to be only part of the solution [ ] . different worldviews and knowledge systems that exist among indigenous australians, including alternative concepts of physiology, pathology and disease causation also contribute [ ] . an often misinformed assumption by health providers of shared understandings [ ] , along with the absence of opportunities and resources to construct a body of shared understanding perpetuate this miscommunication. two specific factors, culture and worldview, are increasingly acknowledged as important antecedents contributing to health literacy [ ] [ ] [ ] [ ] . there are a myriad of different definitions of culture; when referring to culture in this paper we use the broad definition of the culture of a society as "… the totality of its shared beliefs, norms, values, rituals, language, history, knowledge and social character" [ ] . participatory projects working with indigenous communities in the design and development of health education resources have been successful in improving health literacy and participation in healthcare in other disease areas [ , ] . the aim of this research project was to explore the knowledge, perceptions and experiences of remote dwelling indigenous adults and their health care providers relating to hepatitis b infection. we also aimed to gauge interest among indigenous participants in further knowledge of this disease and gain perspectives on how and in what format people could best acquire the information they needed. this was the first stage of a wider participatory action research (par) project with the intention of using the results as the evidence base to inform development of a culturally appropriate hepatitis b educational resource. this project was undertaken in northern australia between july and december . it was based at the health clinic of a remote community in arnhem land, km northeast of darwin (the capital of the nt). this community has a population of , with an average age of years; % are indigenous australians and only . % of the population speak english as their first language. there is an average of . people per available bedroom and % of households are considered to be overcrowded. there are three general stores, a school, a library, a health clinic as well as a police station and a community church. the overall project design was based on par principles; specifically, ongoing consultation, reflection and discussion with the community throughout each iterative cycle. jd (a female non-indigenous researcher and clinician with experience in working in a cross cultural environment) and sb (a female indigenous researcher and health worker in the remote community) worked alongside each other in constructing the interview schedule, recruitment, data collection, analysis and interpretation. this paper reports the results of the first part of this project which was the first formal par cycle and provides the evidence base for the development of a culturally appropriate educational tool for hepatitis b, the second phase of the project (details not presented here). however prior to this project informal discussions regarding the issues facing the community with respect to the burden of disease produced by hepatitis b, the lack of community understanding and the difficulties health workers have in explaining hepatitis b to community members had been discussed within clinic meetings and with the visiting liver clinic service. the impetus for the project came from the community clinic. their enthusiasm for the project led to the development of a collaborative research partnership between the community clinic, the royal darwin hospital liver clinic and menzies school of health research and establishment of the formal par process. ethical approval for the study was obtained from the human research ethics committee of the northern territory department of health and menzies school of health research (hrec) as well as miwatj health aboriginal corporation (an aboriginal-controlled health service representing communities across east arnhem land) and charles darwin university. semi-structured interviews were carried out with groups of people; key informants (health clinic staff, community health educators, liver clinic staff -both urban and remote, − and doctors and nurses, indigenous and non-indigenous), indigenous people living with chb and indigenous community members. interviews explored the background of the individual, their hepatitis b knowledge, their experience of health communication/education about hepatitis b, available resources and their perspectives about potentially useful educational tools. all participants were shown two existing resources; an animation about the liver and its function (chosen as it was part of an electronic education package targeted at indigenous australians) and a flip chart, (developed in victoria, australia, intended for use in the clinic setting and aimed mainly at asian individuals) about hepatitis b and asked to comment on them as a way of generating ideas/preferences for any future educational tool. patient and community member interviewees were also asked from where they acquired their knowledge about hbv, what influenced their current understanding, and barriers to understanding (table ) . jd and sb recruited participants into the study and carried out the interviews; both had received specific training in interview techniques prior to the commencement of the project. all patients were given the option of an accredited interpreter in their first language if this was not english both for the process of obtaining written informed consent and the interview itself. a mixture of purposive (non-probability sampling in which the researchers suggest who to approach to be included in the study based on them possessing certain characteristics [ ]) and network (using existing participants to suggest other people to approach [ ] ) sampling was used to recruit individuals from a range of different backgrounds with a proportionate mix of gender, age and hepatitis b status. the majority of participants were recruited through the community clinic and the hospital liver clinic; however some individuals were recruited through the social and professional networks of the research team. interviews were carried out in numerous settings ranging from the community clinic, our hospital clinic, our research institution, individuals' homes and gardens, under trees and at an international conference ( th australasian viral hepatitis conference, auckland, september ). interviews were audio recorded and ranged in duration from to minutes. information collected in yolŋu matha was translated into english in real time by the accredited interpreter and meaning and understanding clarified by sb (bilingual researcher present at all interviews carried out in yolŋu matha) as part of the recording. transcription of the interviews was in english. an audio diary of the real time experience and reflections on the interviews was kept by jd and sb and included in the data analysis. all participants were offered an aud$ electricity voucher in recognition of their time and effort in contributing to the study. in the process of exploring patients' and providers' knowledge, experiences and perceptions of hbv, data emerged on the potential impact of low levels of health literacy on healthcare interactions and therefore future health outcomes as well as the pathways through which this may occur. as such, we have used paasche-orlow & wolf's model [ ] figure of the pathways that exist between low levels of health literacy and poor health outcomes as an organising model for our data analysis. data analysis was carried out by jd and sb, with input from vj and jsd. it commenced with the first interview and was continuous throughout the project. data immersion consisted of carrying out the interviews, reading the transcripts and listening to the audio recordings multiple times on multiple occasions dispersed over time. sections of text were organised into codes based both on the categories covered in the interview schedules and also inductively as the text was digested and understood. codes were also reflected upon with reference to the passche-orlow & wolf model in particular with regard to the similarities and differences in using this model in this particular cultural context (yolŋu people) for this particular disease (hepatitis b). concurrently and inductively the codes were organised into broader categories and themes. on multiple occasions clarification was sought regarding the cultural context of specific terms and ideas from sb. sb returned to individual participants to verbally clarify findings on a number of occasions however transcripts were not routinely returned to participants for checking. data were organised and managed in nvivo (qsr international pty ltd, victoria, australia). jd, sb, ss & jsd are all clinical care providers as well as researchers and acutely aware of the ethical implications of this within this project particularly for those individuals interviewed who were hepatitis b patients. careful explanation of the fact that the research project and an individual's clinical care are completely separate and mutually exclusive was undertaken with the hepatitis b patient group in particular. care was taken to conduct the interviews completely separately in both time and location from any clinical care so as to maintain this separation. we adhered to the rats guidelines in reporting this project. thirty two semi-structured interviews were carried out between july and september . participants consisted of clinic patients with hepatitis b ( ), other community members ( ) and key informants ( ) . twenty-four ( %) were indigenous people. median age of participants was years (iqr - ) and ( %) were female. highest level of education attained was junior school for one individual ( %), secondary school for ( %) and tertiary education for ( %). all participants had the opportunity to use an interpreter; interviews were carried out using a yolŋu matha interpreter (the principal indigenous language spoken in the community). the remainder were carried out in english. knowledge about hepatitis b: "only your blood can tell the true story" there was a distinct lack of biomedical knowledge regarding chb, especially in the people living with chb group, and even among those who had been previously reviewed in the liver clinic and/or were currently on oral antiviral treatment for chb. people living with chb and community members generally acknowledged that they did not know or have any understanding of what hepatitis b was and were commonly unable to attempt any explanation on direct questioning. however, when contextual translation was provided in yolŋu matha some understanding often emerged: "something like that person will get that virus inside the body. sometimes he [the virus] will be gone and sometimes will stay there for bit long. that's the story i know". "when i see people with hepatitis they have a yellowish thing -eye -you know just around the eye balls and that thing to me, it tells me that the person either have a hepatitis or kidney failure". the word "germ" and an understanding of germs being micro-organisms that required a microscope to visualise them was recurrently touched upon, with specific reference to previous education programmes and research projects carried out in the community both by the aboriginal resource development service (ards) in darwin and menzies school of health research. these experiences appeared to have led to an increased understanding of biomedical concepts around infectious diseases in general and were discussed in a positive light. despite this many misconceptions about hepatitis b from a biomedical perspective were identified, particularly around causation and transmission. in particular the ideas that chb can be caused by smoking, lifestyle factors, diet and lack of exercise were frequently reported by community members: "maybe because i was washing myself too much in cold water it may have caused the sickness or me sleeping outside". "when you smoke you get the sickness in the lungs and in the liver". this was also reflected in comments made by numerous people that before "western influences" chb didn't exist as a problem; it was a "new" sickness that people did not really know much about and could be prevented by reverting to a more traditional lifestyle. many people reported that their underlying beliefs about health and disease are based on traditional medicine including sorcery as causation of disease and traditional plant-based remedies as treatments. although there were no bush medicines reported that can be used to specifically treat chb, a remedy made from paper bark trees was described as being used and felt to be effective for liver sickness in general. the biomedical or "balanda" (white person) version of hepatitis b was very much seen as an alternative explanation; new information that didn't exist in previous generations. there was also some confusion surrounding human immunodeficiency virus (hiv) and chb. some community members reported that the two diseases were one and the same sickness. this misunderstanding appeared to contribute significantly to the sense of stigma or shame around a diagnosis of chb, and that it had to be kept a secret because of what it might reveal about sexual orientation or partner preference. as well as this, the opinion that an individual patient may be to blame in some way for acquiring chb, which appeared to be centred on awareness that chb could be sexually acquired, was recurrently voiced. this lack of biomedical knowledge was not confined to the patient and community members. some key informants, both indigenous and non-indigenous, also acknowledged that they found it a difficult area to understand clearly themselves. multiple health professionals reflected on the role of working in an endemic setting seeing a high volume of people living with chb as necessary to achieve true competency in the management of chb, stating that prior to this, their understanding was more superficial. the topic of hepatitis b is part of the routine curriculum studies undertaken by aboriginal health workers (ahw) and this appeared to be the origin of knowledge for this group, as similar concepts and responses were reported. the concepts of mother to child transmission, sexual acquisition and the infectiveness of blood and other body fluids were expressed by several ahws; however they were less clear about the natural history of the disease, the interpretation or meaning of blood test results, and the potential for treatment or intervention. perceptions of hepatitis b: "it's like a silent killer; i can drop dead anywhere so i take my tablets and pray" people living with chb and community member perceptions about chb tended to portray the disease in a negative light, describing it as a "scary sickness", a "serious infection", a "big sickness". people living with chb in particular described fear as a motivating factor for their actions and behaviours, which either pushed them to take their tablets to prevent imminent death or made them too afraid to attend the clinic, so acting as a barrier to receiving any care. within the key informant group there was recurrent reference to the many more urgent competing health priorities in remote communities, such as ischemic heart disease, diabetes and renal disease. chb, owing to its long term, insidious or asymptomatic nature, in combination with the lack of appropriate resources, resulted in it being neglected and often not adequately addressed. multiple logistical issues were also felt to contribute to an almost fatalistic view of what was achievable, such as: the remote and dispersed nature of the patient population; the difficulty accessing secondary care physicians and investigations, especially liver ultrasound; the turnover of health care professionals, and lack of continuity of care. in the context of these factors it was perceived that chb is just too complex a problem to tackle. it was also noted that even where good quality educational resources are available for other diseases, they are rarely used in clinical practice. instead, they sit on a shelf gathering dust or the technology to use them is either not there or does not work. it is not clear if this is because they are not useful, did not have community input into their development or have not been well implemented or evaluated. "people (with hepatitis b) tend to be asymptomatic for long periods in contrast to chronic diseases like ischemic heart disease, chronic airways disease, chronic kidney disease, diabetes, and day to day problems that people can identify as being directly linked to the condition so it tends to be way down the list of priorities". non-indigenous health worker "the system relies on people being involved for the long haul and yet there's not a single clinic where we were outlasted by the clinic or the nurse manager of the clinic or the gp where we were there for longer than anyone else in all of the east arnhem clinics". non-indigenous health worker "i think, i mean working in the top end i've seen a lot of really nice materials that have been developed educationally and flip books and things. in my experience they're rarely used". among non-indigenous key informants there was a perception that it was not possible to translate certain key words such as 'liver' and 'kidney' accurately into yolŋu matha and hence adequate explanations of hepatitis b were challenging to achieve even with a translator. an indigenous community member working as a translator, however, said that this was not true. "most of the time by and large yolŋu are hunter gather people. they can cut up a kangaroo, wallabies; they can identify those things [liver and kidney] pretty well, they can make that distinction. it is common knowledge to be able to identify them, there are clear words for them [liver and kidney] and they are different". non-indigenous individuals in the study (all key informants) tended to significantly overestimate the depth of shared understanding between themselves and indigenous individuals when discussing chb. when reviewing existing resources with the non-indigenous health workers there was recognition that there were too many medical terms and a feeling that they were too detailed in content. however, the general concepts that were explained in these resources were felt to be appropriate. indigenous participants also described an excess use of jargon but also reported that the concepts used were foreign and difficult to relate to. he is saying he's been to the clinic, they have explained several times. sometimes he doesn't understand [what they are saying], especially the doctors. this lack of shared understanding was also touched upon when discussing the use of ahws as translators in the context of clinic consultations about chb. although a few of the doctors with extensive experience of working in a remote community environment had good insight into the difficulties ahw may face in explaining biomedical concepts, there was a general feeling that having an ahw with them during a consultation to translate their biomedical explanation was adequate to achieve a shared understanding. in stark contrast to this, ahw participants reported finding this expectation overwhelming as they did not feel sufficiently equipped to be able to facilitate a satisfactory explanation due to their lack of understanding of what was being said. if i don't understand the message then how am i gonna convey it. multiple patients voiced the concern that they were asked to have many blood tests related to their diagnosis of chb, without receiving adequate explanation of their purpose, and that there was a lack of follow up to receive and discuss the results. this lack of understanding and communication left them feeling worried, angry and frustrated and in several cases like the clinic staff were purposely hiding something from them, resulting in a lived experience of disempowerment and inferiority. "i hold my temper at that time, when i don't get my results back i feel like i need, i want to do something, like smash windows or something here at the hospital". "i figured there was something wrong with me when they kept on requesting more and more bloods from me". "that's one of the things. sometimes doctors hide something to the patient and they don't want to tell straight". the results described so far highlight factors which all contribute to the patient-provider aspect of the paasche-orlow & wolf model (figure ). as well as clearly impacting on an individual's hepatitis b specific health literacy these factors appear to shape healthcare interactions, potentially representing a foundation step in the pathways that exist between low levels of health literacy and poor health outcomes in indigenous australians. indigenous participants across all groups overwhelmingly cited language as the single most important feature of any potential educational resource and also as the most significant barrier to achieving effective cross cultural communication. "she's saying, she doesn't understand, it's not much meaningful. the words are big words, the numbers are not good, and the words are not good. should be in language". on multiple occasions through the process of interviewing (at the request of individuals normally in the patient group), we used a trained interpreter to provide a brief clinic style explanation of chb, and this appeared to be able to significantly increase an individual's understanding of their illness. it was however emphasised repeatedly that the translation process was not simply a case of turning the english into yolŋu matha and that multiple steps were needed; to ensure the individual translating has adequate understanding, to allow/enable contextual translation, to communicate the message via the interpreter in the appropriate language, to check understanding in language, to ask the interpreter to back translate the participant's understanding and to clarify any miscommunication, as well as great care not to simplify the message too much such that the detail was lost. indigenous participants perceived that the best path is to remove all medical jargon and acronyms and translate the simple english into yolŋu matha, using accurate but "culturally safe" concepts. the value and preference for visual aids, again of a culturally safe and accurate nature, was a predominant comment. it became apparent over the duration of the project that there was a lack of shared understanding of the word "silent" between non-indigenous key informants (health workers) and patients in the context of hepatitis b. whereas the non-indigenous health care professional may use the word 'silent' to describe the immune tolerance (early stage chb when viral load is high but minimal liver damage is occurring) or immune control phase (later stage chb following e antibody seroconversion where viral load is low and minimal liver damage is occurring) of hepatitis b, a yolŋu patient or ahw may interpret this to mean that the sickness is brought about by sorcery a , with negative connotations of retribution or punishment. although not held by all, this was a commonly held belief voiced amongst the indigenous people interviewed. culturally important relationships between certain individuals, which health care providers may not be aware of, were seen as a barrier to effective communication. for example; a well-respected senior male elder in the community may feel uncomfortable with having a younger female interpreter in a medical consultation, as it would infer something negative about his knowledge of the subject or ability to understand the health care worker and so decline the assistance of an interpreter altogether. this can then result in the individual having an inadequate understanding of the information presented to them. the importance of gender sensitivity, not only in a clinical scenario but also in any potential educational resource was touched on by individuals in all groups. the ability for people to speak honestly and in detail about hepatitis b was felt to be culturally difficult between individuals of different gender. patients and community members felt this to be more important if the gender mismatch was between two indigenous individuals and not as significant if the second individual was a non-indigenous individual or a health care professional. however some non-indigenous health care professionals felt that consultations between a health worker and patient of the same gender tended to result in improved cross cultural communication and improved rapport. motivation to understand more about hepatitis b: "we want to learn more about this sickness" despite a lack of biomedical knowledge, indigenous participants passionately voiced a desire to understand more about hepatitis b. the importance of telling the full and true story was emphasised, in not missing out the details, but finding a culturally appropriate contextual translation to allow a shared understanding of the important information. indigenous participants were enthusiastic about spreading this knowledge to all to whom it may be relevant in order to allow them to make choices about seeking management. both indigenous people living with chb and community members perceived that the moral and ethical obligation was on "us", the health care providers, the ones giving injections (vaccination) and taking blood tests to ensure patients were appropriately informed. this understanding was felt to be very powerful in facilitating autonomy and respect, as well as being vital to a respectful patienthealth care professional relationship. "she's saying she wants to learn more about this hepatitis b so she can pass the story to her people, to her family. and to encourage them to come to the clinic and have a check-up". a culturally appropriate education resource: what we need… when discussing educational resources, non-indigenous key informants reported that an analogy with hepatitis b using a local animal (e.g. a crocodile or snake) to represent how the virus can lie dormant in the liver and then suddenly attack resulting in serious health consequences would be culturally appropriate. by contrast, indigenous participants generally preferred more medical imagery requesting to see a real human-like figure with a real liver, and a story based in a culturally appropriate setting. one participant remarked that the majority of local animals are hunted as food by community members, so it would be counterproductive to use them to explain a human sickness -people would then think they could get the disease from the animal. a strong desire to understand the detail about hepatitis b was recurrently expressed but the need for contextual translation done in a culturally appropriate way was stressed. in general, indigenous participants reported a preference for an electronic format with an emphasis on interactive pictures and less text. if text is utilised, it was clear from participants that it must be in yolŋu matha and spoken as well as written. there was a recurrent specific request for a separate "women's business" section to speak about the issues specifically related to pregnancy. figure summarises the important aspects from the results which have been taken forward into the process of developing a culturally appropriate tool to aid in the development of effective treatment partnerships for indigenous patients with chb. in light of our results we have adapted paasche-orlow & wolf's model figure to highlight how the relationships between health literacy and poor health outcomes may operate for indigenous australians with respect to hepatitis b. this study documents low levels of biomedical knowledge about hepatitis b which appear to be influenced by a multitude of factors including culture, gender, competing health priorities and a lack of shared understanding. pessimistic almost fatalistic perceptions of the disease predominated across all groups of individuals interviewed. in terms of experiences the major theme identified was communication particularly the importance of having information available in an individual's first language to aid in effective cross cultural communication. indigenous individual's repeatedly expressed a desire for increased knowledge and insight into the ability of this knowledge to reduce disempowerment and improve hepatitis b specific health literacy. ideas as to how to best enable this to happen included using visual aids, electronic formats, simple language and the absolute requirement for information to be available in yolŋu matha. knowledge and beliefs are important patient factors in the patient-provider interaction component of paasche-orlow & wolf's model linking low levels of health literacy and poor health outcomes. a lack of biomedical knowledge about hepatitis b was identified in indigenous individuals across all groups interviewed. this is consistent with data from indigenous individuals in the torres strait [ ] as well as non-indigenous australians from culturally and linguistically diverse backgrounds [ ] . lack of knowledge and erroneous beliefs about hepatitis b, as well as contributing to low levels of health literacy, may lead to a reduced ability or willingness to participate in decision making about management plans. this in turn may influence adherence with the plan and subsequent necessary self-care activities. multiple factors affecting the provider side of the patient-provider interaction were also identified. communication skills to allow shared understandings to be developed as well as insight into how best to achieve this are crucial in our context, where there are multiple competing priorities; however lack of these skills is identified in our results as an ongoing barrier to achieving shared understandings. in the context of australian indigenous peoples where english is not the first language and culture and worldview are very different we would suggest that the patient-provider interaction not only significantly contributes to health literacy but is a pre-requisite to allowing access & utilisation of care and self-care to occur and so ultimately influencing health outcomes ( figure ) . as well as the patient-provider factors described above, extrinsic factors such as support technologies, health education and resources are identified as key factors to allow optimisation of self-care. the wider project that this research is part of was initiated due to a lack of culturally appropriate resources about chb for use in clinical practice. our data identified a real desire for more knowledge and understanding around chb for all in the community to motivate and empower people living with chb and community members, which in turn should increase selfmanagement in relation to chb. our results identify a clear ambition by community members and people living with chb towards 'critical health literacy' as defined by nutbeam et al. [ ] as the tertiary level of health literacy encompassing not only communication of information and development of personal skills but also personal and community empowerment. there is now increasing experience with the use of innovative, interactive, internet, mobile phone and tabletbased resources to improve health literacy in other settings [ , ] . in the context of indigenous australia, several groups have produced apps in the area of mental health [ ] but robust evaluation of their value is still awaited. in northern australia, christie's research group has proposed a tablet-based, easily transportable, touch pad body resource, which does not contain any embedded health messages, but rather focuses on aspects of a healthy body. their vision is that this could be used as the foundation for a further discussion about the impact of chronic diseases on the body and how treatments act to return the body to a healthy state [ ] . the evidence derived from this project that will be taken forward to phase of the par process and used to guide the development of a culturally appropriate educational tool about hepatitis b is summarised in figure . effective communication is not only central to improving health literacy [ ] , it is a crucial element in achieving culturally safe healthcare, which in essence can be defined as "shared respect, shared meaning, shared knowledge and experience of learning together" [ ] . more recently, research suggesting that some indigenous patients believe that health care workers deliberately withhold information from them highlights the extreme lack of trust that can develop as a consequence of ineffective communication [ ] . as communication transcends all aspects of health literacy, hence "culturally safe communication" at both a system and individual level is clearly integral to its improvement. culturally safe communication has also been suggested as being important in reducing ethnic and racial disparities in healthcare [ ] . specifically in the australian aboriginal context, involvement of the local community in developing and implementing health education programmes, so they are culturally safe, has been shown to directly influence their effectiveness [ , , ] and attention to worldview and language are argued to be integral to achieving improvements in health education [ ] . it is therefore disappointing that more than a decade after the publication of cass et al's [ ] paper documenting the pervasive nature of miscommunication between indigenous people and their health care professionals, our results show the major barrier to achieving critical health literacy is still poor cross-cultural communication. consistent with the view of vass et al. [ ] who suggest "the health literacy of indigenous australians can be improved by promoting the oral use of the peoples' first language in the health sphere" indigenous participants anticipate they will better understand and be able to process and act on information given to them in their own language. our results also provide further insight into the complexity of achieving effective and culturally safe communication in this setting, when, for example, the lack of a shared understanding of one word -"silent"which is used so commonly in clinical practice with hepatitis b patients can lead to such significant misunderstanding. we have also highlighted the potential for miscommunication to be perpetuated in health settings when communities are not adequately consulted about health education and health promotion resources. the well-meaning but mistaken beliefs among non-indigenous key informants in this study about the appropriateness of using animal analogies when discussing how hepatitis b affects the liver or the mistaken belief that the lack of a direct translation of a word prohibits meaningful translation of key messages, are two examples from our data. the negative perceptions and fear of hepatitis b as a disease may originate from the low levels of health literacy documented and contribute to stigma and potential non-disclosure of diagnosis as well as having implications for individual clinical care and the success of public health interventions. this pessimism may have been confounded by the lack of shared understanding and different health beliefs about causation in the context of provider-patient interactions. additionally, the non-indigenous key informants in this study perceived that there are multiple logistical barriers and competing priorities to providing effective and appropriate long term care for people living with chb and felt overwhelmed by the task. this negativity is likely to adversely influence an individual's access and utilisation of care and so contribute to the relationships between limited health literacy with inequitable health outcomes as per paasche-orlow & wolf's model. our study is limited by the fact it only included one community and because of multiple previous education and research projects in this community in the discipline of infectious disease, it is likely that this community has higher health literacy that most regarding infectious diseases specifically. cultural practices, traditions and world view may be totally different to other australian indigenous peoples; however, our findings about the importance of communications and shared understandings are likely to transcend region and apply to all indigenous australians. this view is supported by the similarities between our findings, and those of preston-thomas et al., who investigated hbv knowledge in a completely different group of indigenous australians -torres strait islanders. although not directly translatable to other cultures, it is likely that the modified factors highlighted in figure will be of greater importance to those people living with chb from culturally and linguistically diverse backgrounds, particularly if they are receiving care in a country where the language of health care is not their own first language. although low levels of biomedical knowledge about chb are clearly a significant barrier and an important influence on health literacy our findings resonate more clearly with christie et al's [ ] definition of health literacy. in this context, what is really critical to improving health literacy is developing a shared understanding between patients and providers, which hinges on effective communication. if we can use the insight we have gained from this study and work with the people who provided it to develop an educational tool grounded in their culture, in their first language and make it easily accessible, that would be a first step to improving health literacy about chb. qualitative research using a participatory approach holds promise of breaking cross-cultural barriers in health communication and health care. we acknowledge that there will also need to be appropriate implementation and evaluation of the resulting resource to ensure its success. biomedical knowledge about hepatitis b is low in this indigenous community in the northern territory, experiences and perceptions about chb are in general negative and at times nihilistic. however there is a strong desire for increased knowledge and evidence of increased understandings with contextual translation of information. patient provider interactions leading to the development of shared understandings between indigenous people living with chb and the health care professionals looking after them are the foundation for improving health literacy and so health care outcomes related to chb. language and using a culturally appropriate worldview are crucially important in developing an educational resource to aid in developing treatment partnerships for indigenous patients with chb. maintaining a participatory approach to development should help to reduce disempowerment and overcome some of the barriers to its implementation and success. endnote a sorcery as a cause of disease is a commonly held belief in indigenous communities in arnhem land particularly where a death is sudden, unexplained or happens to someone who is seen outwardly as healthy. it can be a form of retribution or punishment but is not always viewed in this way. closing the gap key facts hepatitis b in australian aborigines and torres strait islanders: georgraphical, age and familial distribution of antigen subtypes and antibody hepatitis b virus markers in children and staff in northern territory schools establishment of a surveillance system (utilising midwifes data collection systems) for monitoring the impact of hepatitis b vaccination on the population prevalence of chronic hepatitis b virus infection in australia hepatitis b prevalence and prevention: antenatal screening and protection of infants at risk in the northern territory screening for hepatitis b in east arnhem land: a high prevalence of chronic infection despite incomplete screening incomplete protection against hepatitis b among remote aboriginal adolescents despite full vaccination in infancy the end of the australia antigen? an ecological study of the impact of universal newborn hepatitis b vaccination two decades on the burden of chronic hepatitis b virus infection in australia a national health system response to chronic hepatitis b: using population data to define gaps in clinical care provision distribution of viral hepatitis in indigenous populations of north america and the circumpolar arctic the new zealand hepatitis b screening programme: screening coverage and prevalence of chronic hepatitis b infection responding to australia's national hepatitis b strategy - : gaps in knowledge and practice in relation to indigenous australians a situational 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end confusion. washington dc: the national acadamies the sage dictionary of sociology participatory action research in indigenous health health promotion resources for aboriginal people: lessons learned from consultation and evaluation of diabetes foot care resources network sampling. encyclopedia of survey research methods health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the st century ugandan youth preferences for content in an internet-delivered comprehensive sexuality education programme community desires for an online health information strategy the effectiveness of a suicide prevention app for indigenous australian youths: study protocol for a randomized controlled trial the evolving concept of health literacy cultural safety -what does it mean for our work practice? can cultural competency reduce racial and ethnic health disparities? a review and conceptual model culturally appropriate methods for enhancing the participation of aboriginal australians in health-promoting programs health literacy and australian indigenous peoples: an analysis of the role of language and worldview submit your next manuscript to biomed central and take full advantage of: • convenient online submission • thorough peer review • no space constraints or color figure charges • immediate publication on acceptance • inclusion in pubmed, cas, scopus and google scholar • research which is freely available for redistribution we would like to thank all participants and local health clinic staff who all so generously gave their thoughts and time to contribute to this study. key: cord- -ng xb c authors: lassmann, britta; madoff, lawrence c. title: highlights from the (th) international meeting on emerging diseases and surveillance (imed ) vienna, austria from nov to , date: - - journal: int j infect dis doi: . /j.ijid. . . sha: doc_id: cord_uid: ng xb c nan [ _ t d $ d i f f ] the century of epidemics imed speakers from all regions of the world agreed that over the course of the coming century, epidemics are likely to occur more frequently, as will the risk of global pandemics. the world's increasing population, higher demand for protein, climate change, increasing mobility, social vulnerability and political instability were only a few of the factors discussed that contribute to the projected increase. at the same time, rapid advances in science and improvements in technology and data sharing offer new ways to prevent, detect, predict and respond to those threats. although we are not able to prepare when, where or which pathogen will emerge next, we will be better prepared to prevent the next pandemic. the general public's interest in emerging infectious diseases was highlighted in a poster presentation by dr. [ _ t d $ d i f f ] daniel lucey and colleagues, who showed details of a planned exhibit on ''exploring pandemics: a smithsonian museum endeavor for the public'' at the smithsonian national museum of natural history in washington, dc. the exhibit is scheduled to open in early through early , coinciding with the -year commemoration of the - influenza pandemic and will offer the public an opportunity to explore and understand better epidemics caused by zoonotic viruses from around the world. [ _ t d $ d i f f ] one world -one health: transboundary emerging diseases in humans, animals and wildlife imed opened with a plenary session dedicated to transboundary emerging diseases in an increasingly interconnected world. professor albert osterhaus talked about hiv, avian flu, sars, mers-cov, ebola and zika as some of the diseases that originated in animals and passed to humans. while many of these have been well studied, there remain significant gaps in understanding the linkages of infection, making it challenging to predict and prepare for the next epidemic. several speakers presented results on studies that further examined zoonotic disease spread and aimed at identifying pathogens and environments most conducive to spillover to humans. professor christine kreuder johnson and professor rudovick kazwala discussed results from usaid's emerging pandemic threats predict project, that uses a riskbased strategy to investigate emerging diseases threats. dr. kreuder johnson's team examined common animal hosts and convergent mechanisms involved in past spillovers of zoonotic viruses in order to identify high-risk interfaces for surveillance activities and interventions aimed at prevention. the team found that viruses transmitted to humans had significantly higher host plasticity. in other words, they were reported in a more taxonomically diverse host range. viruses with higher host plasticity were also more likely to amplify viral spillover by secondary human-to-human transmission and have broader geographic spread. dr. kazwala reported on results from the predict project in tanzania where bats, rodents and non-human primates were subjected to molecular virology diagnostic tests and revealed the presence of viruses including novel viruses. international journal of infectious diseases s ( ) - international journal of infectious diseases j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / i j i d during the oral abstract presentation session on one health -diseases across species boundaries, toph allen from ecohealth alliance and colleagues shared results from an updated model assessing the global distribution of zoonotic emerging infectious disease risk. highest risk of emergence was concentrated in tropical regions where wildlife biodiversity is high, human populations dense and growing, and land use change is occurring rapidly. these regions were thought most likely to produce the next emerging infectious disease event, and therefore most valuable for surveillance in wildlife, livestock or people. dr. [ _ t d $ d i f f ] ireen shanta and colleagues from the international centre for diarrheal disease research in bangladesh reported data from a cross sectional survey of , households to identify hotspots of human exposure to rodents, bats and monkeys in bangladesh. they concluded that more than . million people in bangladesh are exposed to rodents each month, more than , to bats and more than , to monkeys putting them at risk for contacts to pathogens from those species. to identify early signals for the emergence, spill over and spread of animal pathogens, dr. julio pinto (food and agricultural organization of the un) then called for a new mindset in the way the international community coordinates and manages disease emergence. the new approach should be multi-disciplinary and should strengthen local capacities in epidemiological analysis, use open analytical tools and gis platforms, integrate new technologies such as mobile devices and rapid diagnostics and be committed to the open sharing of data. since the last imed, flaviviruses have emerged as prominent threats in the world. the flavivirus session addressed the ongoing zika virus epidemic in the americas and other regions of the world and the yellow fever virus outbreak in africa, which threatened to go global. a major concern of the zika virus epidemic is the association of maternal infection with birth defects, a complication that has not been seen with flavivirus infections in humans in the past but has been seen with congenital infections in animals. professor james maclachlan discussed what is known about congenital infections of animals with flaviviruses and highlighted the critical role of the timing of infection. for example, infections with bluetongue virus (btv) have clearly shown the critical role of gestational age in determining outcome. fetuses infected prior to mid-gestation that survive congenital btv infection are born with cavitating central nervous system defects that range from severe hydranencephaly to cerebral cysts (porencephaly). bunyaviruses cause gestational age-dependent teratogenesis in fetal ruminants but, in addition to cavitating central nervous system defects, affected fetuses are born with contracted limbs -congenital hydranencephaly/arthrogryposis syndrome. dr. vanessa van der linden, a pediatric neurologist from recife, in northeastern brazil then gave a heartbreaking description of zika[ _ t d $ d i f f ] -related neurologic complications. recife is one of the areas hardest hit by the zika epidemic and dr. van der linden was one of the first to recognize the microcephaly epidemic in this area. she reported patients suffering from the full range of manifestations including craniofacial disproportion, spasticity, seizures, irritability, brainstem dysfunction, limb contractures including arthrogryposis, hearing and ocular abnormalities, and brain anomalies detected by neuroimaging. she emphasized the importance of vigilant health professionals to recognize changes in the neurodevelopment during the first years of life and the necessity of a team approach to provide the best care to affected children and support for their families. professor oyewale tomori from nigeria highlighted the angolan yellow fever outbreak, the largest in years, that spread to neighboring countries, and quite worrisomely via travelers to asia. despite the long availability of an effective vaccine, the shift of hotspots from west to central africa, failures of vaccination policy and vaccine shortages combined to produce this global threat. rapid urbanization, mass population movements, climate change, and resistance to pesticides and available treatments increase the risk of epidemics in the future, argued dr. mercedes tatay from doctors without borders. current strategies to prevent major outbreaks of disease show limited success. epidemics continue to occur with devastating consequences for less developed countries. she argued that in reality, not all epidemics are viewed equally. the global health security concept at the heart of the international health regulations defines protection against a threat as the main trigger for international action. she concluded that emergency response needs to be prioritized not in competition with long-term goals such as public health surveillance and health systems strengthening. west africa's ebola epidemic was unprecedented with more than , reported cases, more than , reported deaths and more than , survivors. in response to the epidemic, four global commissions were established to critically evaluate the national and global response and to enhance preparedness to prevent, detect, and respond to future infectious disease threats. professor [ _ t d $ d i f f ] daniel lucey summarized the commissions' recommendations including the importance of strengthening national health systems, consolidating and strengthening world health organization (who) emergency and outbreak response activities, and enhancing research and development. who agreed to one of the most profound transformations in the organization's history by establishing a new health emergencies programme. the programme is designed to add operational capabilities for outbreaks and humanitarian emergencies to complement its traditional technical and normative roles. similarly, the recommendations of the review committee on the role of the international health regulations (ihr) was focused on the implementation aspects of the ihr. the implementation of a vaccine trial during an epidemic was discussed by dr. barbara mahon, us cdc lead for the sierra leone trial to introduce a vaccine against ebola (strive), a phase / trial sponsored by cdc in collaboration with the college of medicine and allied health sciences, university of sierra leone, and the ministry of health and sanitation. the trial was designed to accelerate introduction and use of the recombinant vesicular stomatitis virus zaire ebola vaccine (rvsv-zebov) among at-risk people in sierra leone with concurrent evaluation of the efficacy and safety of the vaccine. she talked about the challenges implementing strive in the face of limited infrastructure, high community concern, and changing epidemiology. preliminary analysis of safety data indicated no vaccine-related deaths or other serious adverse events; although strive did not produce an estimate of vaccine efficacy because of low case frequency as the epidemic was controlled, data on safety and immunogenicity will support decisions on licensure of rvsv-zebov. the importance of open data sharing during epidemics and ethical challenges of using big data for early detection and prevention were discussed during a roundtable discussion moderated by professor effy vayenna who was joined by experts from the who, the wellcome trust and the centre on global health security (chatham house, london). the importance of communicating to the press and public during an outbreak and how to best communicate uncertainty was reviewed by helen branswell of the us-based stat news. she noted the importance of building rapport between public health authorities, scientists and journalists prior to the onset of an outbreak. dr. edward rubin presented advances in diagnosis and how the genomic revolution and acceleration of dna sequencing throughput allows us to increasingly consider unbiased metagenomic analysis as a tool to detect emerging diseases. the lack of therapeutics for the next viral epidemic were discussed by professor paul tambyah. in a separate session, the challenges posed by climate change on infectious disease outbreaks and how to best prevent and track diseases in mobile populations were discussed. dr. joel montgomery stated that while researchers are understanding how changes in temperature, precipitation and vegetation phenology impact malaria and certain arbovirus vectors, relatively less attention has been paid to the impact of climate change on neglected tropical diseases (ntd) and the challenges migration may pose to ntd elimination efforts. the ''tracking emerging diseases'' session highlighted innovations in disease surveillance and the increasing role of informal sources to detect unusual health events early. dr. mark smolinski, the chief medical officer and director of global health threats at the skoll global threats fund described a transformation of citizen engagement in public health through systems that empower users to directly report on symptoms of disease via email and smartphone technology. these new and innovative systems provide early warning for outbreaks and other health and safety issues, even before users seek health care, and have the potential to transform rapid risk assessment and epidemiological studies. further exploring the role of informal data sources to detect outbreaks earlier, professor anna thorner discussed how physician searches using uptodate -an evidence based, online, clinical decision making tool that is continuously updated -can be used to detect outbreaks early on before cases are reported and confirmed. the european migrant crisis has raised questions regarding the re-emergence of infectious diseases and the monitoring and screening of migrants arriving in europe and elsewhere. in a session presented in collaboration with the european society for clinical microbiology and infectious diseases, physicians from germany and turkey, both countries with a recent high influx of refugees, talked about their countries' challenges and experiences in providing health care and preventive services to refugees and asylum seekers. they called for uniform screening practices and early access to primary and specialized healthcare and emphasized the need for appropriate vaccination coverage. they were joined by colleagues from italy and switzerland discussing the related topics of disease surveillance and tracing antibiotic resistance in mobile populations. [ _ t d $ d i f f ] antimicrobial resistance in the one health context antibiotic resistance is a major global public health concern and resistance is growing faster than new drugs are being developed. antibiotic resistance needs to be understood in the one health context. the importance of the food chain as a source for emergence and spread of antimicrobial resistance between animals and humans was highlighted in a nation-wide study in lebanon. dr. ghassan matar described a direct transfer of resistant determinants in bacterial clones from animal food products to humans. but understanding antimicrobial resistance is expanding even further, from human and animal antibiotic use to the human influence on resistance in the environment. dr. ursula theuretzbacher noted that the link between the animal and human sector was well studied and led to policy changes in some parts of the world. such regulatory initiatives are still missing in the environmental field which is usually not included in the one health approach to tackle the global resistance problem. the direct release of multidrug resistant bacteria from healthcare settings, antibiotic manufacturing facilities and animal farms into the environment as well as the pollution of the environment with high concentrations of antibiotics create a dangerous resistance reservoir. drs. peter daszak and dennis carroll closed imed with a plenary talk on the proposed ''global virome project'', a global initiative to map all of the planet's viral threats over the next years which would represent a dramatic step towards knowing our viral enemy. researchers so far have identified only the tip of the iceberg of viral threats and even fewer of these viruses had effective vaccines or antiviral agents developed. the speakers presented viral discovery data estimating that there are around , yet-to-be-discovered viral species capable of posing public health threats circulating in the world. they discussed the resources and effort it will take to realize this vision and the technical advances that will make it possible. toward a common secure future: four global commissions in the wake of ebola implementing an ebola vaccine study -sierra leone key: cord- -ind t authors: hwang, stephen w.; dunn, james r. title: homeless people date: journal: handbook of urban health doi: . / - - - _ sha: doc_id: cord_uid: ind t nan environment that warrant scrutiny. for example, both questions will lead to a consideration of the availability of low-cost housing and the ability of the health care system to care for patients with severe mental illness. however, the distinction between these two questions is important as they distinguish factors associated with the likelihood of being homeless due to health reasons versus the likelihood of consequences given homelessness. at another level, it is also important to distinguish if outcomes and their associated factors vary between cities, both in terms of the structural factors that generate homelessness and (given homelessness) health of those who are homeless. these questions frame the issue of the impact of the urban environment on the health of disadvantaged populations. in the course of such discussions, disagreement often arises as to whether homelessness should be considered primarily the consequence of individual vulnerabilities and failings, or the result of structural inequities in the social, economic, housing, and health care systems. rather than creating an either/or distinction, we will approach homelessness as the result of a complex interaction between individual vulnerabilities and structural forces in the urban environment. in most cases, the relative importance of these factors in determining the health of homeless people and the prevalence of homelessness remains the subject of ongoing debate. the burden of illness and disease is extremely high among homeless people (levy and o'connell, ) . however, any consideration of the common health problems of homeless people must first recognize the large degree of heterogeneity among people who are homeless. among street youth, single men, single women, and mothers with children, the patterns of illness differ notably. adolescents suffer from high rates of suicide attempts, sexually transmitted diseases, and pregnancy (greene and ringwalt, ; greene and ringwalt, ; greene, et al., ; feldmann and middleman, ) . female heads of homeless families tend to have far fewer health problems than single homeless women, although their health is poorer than their counterparts in the housed general population (robertson and winkleby, ) . homeless single men have a higher prevalence of alcohol abuse and drug abuse, whereas single women have a higher prevalence of serious mental illness (fischer and breakey, ) . health status also tends to be correlated with a person's history of homelessness. individuals with severe mental illness, substance abuse, and medical conditions are overrepresented among the chronically homeless, whereas those who are homeless for a transient period lasting only a few weeks or months are more likely to be relatively healthy (kuhn and culhane, ) . although chronically homeless people make up only about % of all individuals who experience homelessness in a given year, they account for a disproportionately large share of the demand for shelter beds and health care services for homeless people (burt, ) . in addition, the public's perception of homeless people often reflects a stereotyped image of this highly visible subgroup. cross-national comparisons of disease patterns among homeless people reveal the strong effect of social factors within each country. among homeless men in tokyo, japan, morbidity due to alcohol dependence (but not drug use) is common, as are musculoskeletal injuries incurred doing construction work (takano, et al., b) . in contrast, % of homeless people in amsterdam, the netherlands, suffer from drug abuse or dependence (primarily heroin), and most are chronically homeless (sleegers, c ). the prevalence of serious mental illness and substance abuse is high among homeless persons. in a nationwide u.s. survey of homeless people, % had mental health problems, % had an alcohol and/or drug problem, and % had concurrent mental health and substance use problems (burt, ) . common psychiatric diagnoses among homeless people include major depression, bipolar disorder, schizophrenia, and personality disorders. a systematic review of the prevalence of schizophrenia in homeless persons found rates ranging from to % and a weighted average of % in the ten methodologically strongest studies . characteristics associated with a higher prevalence of schizophrenia were younger age, female sex, and chronic homelessness. marked cross-national variation is seen in the prevalence of schizophrenia, with prevalence rates of - % reported among homeless people in sydney, australia (teesson, et al., ) . the prevalence of substance abuse is extremely high among homeless single adults. in a study from st. louis, missouri, large increases were seen in the prevalence of drug use among homeless men and women between and . in , % of men and % of women had an alcohol or drug use disorder (north, et al., ) . in another study, about three-quarters of homeless adults met criteria for substance abuse or dependence (o'toole, et al., ) . homelessness increases the risk of adverse health outcomes among substance abusers: in five canadian cities, the risk of a non-fatal overdose was twice as high among illicit opiate users who were homeless compared to those who were housed (fischer, et al., ) . homeless adolescents also have very high rates of mental health problems and substance abuse. in a study from seattle, % of street youths had been physically and/or sexually victimized after leaving home, and % met criteria for posttraumatic stress disorder (stewart, et al., ) . across the u.s., % of street youth and % of shelter youth had used illicit drugs other than marijuana since leaving home, in comparison to % of youth who had never been runaway or homeless (greene, et al., ) . street youth use a wide range of drugs, including hallucinogens, amphetamines, sedative/tranquilizers, inhalants, cocaine, and opiates. unfortunately, the initiation of injection drug use is quite common, with an incidence rate of . per person-years among street youth in montreal (roy, et al., ) . infectious diseases are a common cause of health problems in homeless people (raoult, et al., ) . the most serious of these infections include tuberculosis (tb), human immunodeficiency virus (hiv) infection, viral hepatitis, and other sexually transmitted infections. outbreaks of tb among homeless people have been reported frequently, especially in individuals co-infected with hiv (barnes, et al., ; mcelroy, et al., ; morrow, et al., ) . the incidence of active tb in a cohort of homeless people in san francisco between to was per , , or times higher than that seen in the u.s. general population in (moss, et al., ) . homeless people with tb require more hospital-based care than non-homeless people with tb, resulting in average hospital costs that are higher by $ , per patient. (marks, et al., ) contact tracing in the homeless population is difficult, and in one study only % of identified contacts completed treatment for latent tb infection (yun, et al., ) . among street youth, latent tuberculosis is more common than in the general population, but probably less prevalent than among homeless adults. in a study conducted in sydney, australia, % of homeless young people aged - years had latent tb infection (kang, et al., ) . homeless people are at increased risk of hiv infection. data from an older u.s. survey conducted from to in cities found median hiv seroprevalence rates of . % in adult men, . % in adult women, and . % in youths (allen, et al., ) . in more recent studies, hiv seroprevalence was . % among homeless and marginally housed adults in san francisco in , a rate five times higher than in san francisco generally (robertson, et al., ) . hiv infection was present in . % of homeless veterans admitted to residential programs from - (cheung, et al., ) . female street youth and young homeless women who are involved in prostitution are at increased risk of hiv infection, due to both injection drug use and risky sexual behaviors (weber, et al., ) . in one study of homeless adolescents, the hiv infection rate was alarmingly high at % (beech, et al., ) . among substance users, homelessness is associated with higher rates of hiv seroprevalence (surratt and inciardi, ; smereck and hockman, ) . among hivinfected persons, those who are unstably housed (homeless or temporarily staying with friends or family) are less likely to receive adequate health care than those who are stably housed (smith, et al., ) . homeless people are at increased risk of viral hepatitis, primarily due to high rates of injection drug use. infection with hepatitis c was found in % of homeless men in los angeles , % of individuals using a mobile medical van in new york city (rosenblum, et al., ) , and % of homeless persons in oxford, england (sherriff and mayon-white, ) . in a veterans affairs population, the prevalence of anti-hepatitis c virus antibody was . % and the prevalence of hepatitis b surface antigen was . % (cheung, et al., ) . among street youth, the prevalence of these markers of infection was also high: . % and . %, respectively, in montreal (roy, et al., ; and . % and . %, respectively, in a northwestern u.s. city (noell, et al., b) . sexually transmitted diseases (stds) are a particularly serious problem among street youth. in a longitudinal study of homeless adolescents, the annual incidence of chlamydia trachomatis infection was . % in females and . % in males; the annual incidence of herpes simplex virus type was . % in females and . % in males. (noell, et al., ) a study of street youth and sex workers in quebec city, canada found that % of women less than years old were infected with chlamydia trachomatis and . % had neisseria gonorrhoeae (poulin, et al., ) . newer urine-based screening tests make it easier to screen homeless youth for stds in outreach settings (van leeuwen, et al., ) . common chronic diseases, including hypertension, diabetes, chronic obstructive pulmonary disease (copd), seizures, and musculoskeletal disorders, are often undiagnosed or inadequately treated in homeless adults. relatively little research has focused on these medical conditions in the homeless population. the prevalence of hypertension was higher among homeless clinic patients than among nonhomeless patients at an inner-city primary care clinic ( % vs. %) (szerlip and szerlip, ) . the prevalence of diabetes is similar in homeless and non-homeless individuals, but homeless people with diabetes face a number of serious barriers to appropriate disease management, including lack of access to a suitable diet and dif-ficulties coordinating medication administration with meal times (hwang and bugeja, b) . glycemic control was found to be inadequate in % of homeless diabetics in toronto (hwang and bugeja, b) . smoking rates are extremely high (about %) among homeless people (connor, et al., ) . as a result, copd is a common health problem among older adults. in a study of shelter residents in san francisco, the prevalence of copd based on spirometry was %, or more than twice the prevalence in the general population (snyder and eisner, ) . smoking also contributes to the high risk of cancer, especially among homeless single men. in a study from scotland that adjusted for age and socioeconomic deprivation, the incidence of cancer of the oral cavity and pharynx, larynx, esophagus, and lung in homeless men was %, %, %, and % higher than expected, respectively (lamont, et al., ) . homeless people are also less likely to receive recommended cancer screening than the general population: among homeless women age and over in los angeles county, only % had undergone a pap smear and only % had undergone a mammogram within the last year (chau, et al., ) . thus, interventions such as smoking cessation treatment and routine preventive health services may provide significant benefit. although it is not surprising that homeless people with mental illness often receive inadequate care for medical comorbidities, the adequacy of care differs according to type of mental illness. homeless people with schizophrenia receive less detailed physical examinations, fewer primary care visits, and less preventive health services than homeless people with major depression . while it is unknown if these differences are due to patient factors, provider factors, or both, careful attention clearly needs to be paid to the physical health needs of homeless people with psychoses. trauma and injuries are significant hazards associated with life on the street (staats, et al., ) . in a sample of homeless and marginally housed people in san francisco, % of the women and % of the men had been sexually or physically assaulted in the last year (kushel, et al., ) . among women, being homeless (compared to being marginally housed) was associated with a more than -fold increase in the risk of sexual assault. in sydney, australia, % of shelter residents reported experiencing a serious physical assault in their lifetime, and half of the women reported having been raped (buhrich, et al., ) . among homeless youth in los angeles, reported exposure to violence was found to be equally high among males and females (kipke, et al., ) . foot problems are very common among homeless adults due to prolonged standing, long-term exposure to cold and damp, ill-fitting footwear, and inadequate foot hygiene. problems can range in severity from mild blisters and fungal infections to debilitating chronic venous stasis ulcers, cellulitis, diabetic foot infections, and frostbite. other common skin problems include sunburn and bites due to infestations by head lice, body lice, scabies, or bedbugs (stratigos and katsambas, ) . the prevalence of serious dermatologic conditions, while probably quite high among street-dwellers, appears to be relatively low among homeless people living in shelters that provide adequate clothing, laundry facilities, bathing facilities, and medical care. in a study of men staying at such a shelter in boston, the majority of individuals had relatively normal findings on skin examinations (stratigos, et al., ) . dental problems are an extremely prevalent and troubling but often-neglected problem for many homeless people. common conditions include advanced caries, periodontal disease, and ill-fitting or missing dentures. these problems may be related to poverty, lack of access to dental care, and substance use, rather than homelessness per se. in a study comparing homeless and domiciled veterans in veterans affairs rehabilitation programs for substance abusers, the two groups had similarly poor oral health (gibson, et al., ) . given the high prevalence of illness among homeless people and the adverse health effects of homelessness itself, it is not surprising that homeless people have very high mortality rates. men using homeless shelters are to times more likely to die than age-matched men in the general population (barrow, et al., ; hwang, a) . homeless women - years of age have mortality rates that are to times higher than in the general population (cheung and hwang, ) . common causes of death among homeless people under the age of are unintentional injuries, drug overdoses, aids, suicide, and homicide (hwang, et al., ; . in a longitudinal cohort study of street youth in montreal, the standardized mortality ratio was . ; hiv infection, daily alcohol use in the last month, homelessness in the last months, drug injection in the last months, and male sex were independent predictors of mortality (roy, et al., ) . among homeless women, major barriers to contraception include cost, fear of side effects or potential health risks, and the partner's dislike of contraception . pregnancy is particularly common among homeless adolescents. in a u.s. sur vey of runaway females age - years, % of streetdwelling youths and % of those residing in shelters were currently pregnant (greene and ringwalt, ) . in a group of pregnant homeless women, the risk of low birth weight (less than , gm) was %, compared to the national average of % (stein, et al., ) . lack of prenatal care and severity of homelessness (homelessness in the first trimester of pregnancy, number of times homeless, and percentage of life spent homeless) were independent risk factors for low birth weight. the health of children in homeless families has been the focus of relatively little research. some but not all studies of these children have found an increased prevalence of behavioral and mental health problems compared to children in housed low-income families (bassuk, et al., ; vostanis, et al., ) . infectious diseases are a significant concern in these children (ligon, ) . up to % of children in homeless families in new york city suffer from asthma, a rate six times higher than the national rate in children (mclean, et al., c) . the medical literature has usually examined health problems from the perspective of the individual homeless person, and has given relatively little attention to the urban environment within which these health problems arise and must be ameliorated. this section addresses this gap by highlighting dimensions of the urban environment that affect, through interaction with individual vulnerabilities, the prevalence of homelessness and/or the health of homeless people. the following is not intended to be a comprehensive listing, but rather a selection of important determinants about which at least some information is available. these determinants have been grouped into categories encompassing the demographic and physical characteristics of urban centers (population and climate), their socioeconomic and service-delivery structures (income and poverty, social welfare systems, and health care systems), and their spatial and political organization (urban geography and urban governance). although these dimensions may have differential effects on the health of various subgroups of homeless people (e.g., youths, single adults, and families), these differences are not discussed in depth here. homelessness is a problem in cities across the u.s., as demonstrated by the fact that federally-funded health care for the homeless programs exist in cities in all states, the district of columbia, and puerto rico (health care for the homeless information resource center). there is limited information on the relationship between population size and prevalence of homelessness in different urban centers. one reason for this paucity of data is the logistical difficulty of conducting an accurate count of homeless persons, particularly those living on the street. another reason is that point-prevalence counts of the homeless population cannot be used to determine how many individuals are homeless in a city over an entire year, especially given seasonal fluctuations in the homeless population and the fact that homelessness is a transient state. counts of shelter users are particularly informative when all shelters contribute to a common administrative database, because this makes it possible to determine the total number of individuals who use shelters in a particular city over the course of a year, rather than simply the number of shelter users at a single point in time (metraux, et al., ) . in , an estimated . % of the . million residents of philadelphia and . % of the . million inhabitants of new york city stayed at a homeless shelter at least once (culhane, et al., ) . in toronto, canada, . % of the city's total population of . million used a homeless shelter during . these figures are remarkably similar and strikingly high. thus, homelessness is quite common in large urban centers, although for many individuals the duration of homelessness is quite brief. in a u.s. survey of homeless people, % had been homeless for only months or less, % had been homeless for - months, and % had been homeless for more than one year (burt, ) . cross-sectional counts of the number of shelter residents provide an important but somewhat less accurate picture of the homeless population. the maximum size of a city's shelter population is obviously determined by the number of available shelter beds. in a city with few shelters, this can create the illusion of a smaller homeless population than is actually the case. in addition, shelter beds may be less widely available in cities that do not experience severe cold weather in the winter. in the nine largest metropolitan areas in canada, the number of shelter beds per capita ranges more than four-fold, from to per , population (hwang, ) . the number of shelter beds per capita is not significantly correlated with population size. interestingly, the lowest number of shelter beds per capita in canada was observed in vancouver, a city with a very mild climate, and the highest figure was seen in calgary, a city with extremely cold winters. overall, this evidence suggests that episodes of homelessness are quite common among residents of major urban centers, but there is significant variation in the prevalence of homelessness across cities that does not necessarily correlate with population size. a related question is the role of migration in determining the size of the homeless population in urban centers. whereas some homeless people are migrants who were homeless before or upon their arrival in the city, others are local residents who have become homeless. in a nationwide u.s. survey, % of homeless people reported living in the same city where they became homeless (burt, ) . among the % of individuals who had moved from one location to another during their current episode of homelessness, the most common pattern was a net flux from urban fringes and medium-sized cities into large central cities. the most commonly cited reasons for these moves were lack of available jobs, lack of affordable housing, and eviction (burt, ) . climate is an interesting example of a characteristic of the urban environment that affects both the prevalence of homelessness and the health of homeless people. certain cities in warm regions may become a preferred destination for people who are homeless or at high risk for homelessness. as noted above, in cities with warmer climates, a larger proportion of the homeless population is likely to be found on the street rather than in shelters. people living on the street are more likely to be disengaged from the health care and social service systems, and typically these individuals have poorer health than shelter-dwelling homeless people (cousineau, ) . in colder climates, exposure to the elements has an obvious adverse impact on the health of homeless people, who face serious risks from trench foot, frostbite, and injury or death from hypothermia (tanaka and tokudome, ) . conversely, in hot weather, homeless people may experience severe sunburn, heat exhaustion, or heat stroke. the prevalence of severe poverty among the residents of an urban area is certainly an important factor affecting the prevalence of homelessness. poverty alone, however, does not necessarily lead to homelessness. data from nine u.s. cities demonstrate wide variation in the proportion of a city's poor residents that stays at a homeless shelter over the course of one year, ranging from a low of . % to a high of . % (metraux, et al., ) . some have argued, based on historical data, that an increase in the number of unmarried men with very low income is a particularly important explanatory factor for adult homelessness (jencks, ) . during the latter half of the twentieth century, the earning potential of men with limited education was greatly diminished by the decline of manufacturing jobs in urban centers (wilson, ; . at the same time, the availability of open-market sources of low-cost housing such as single-room occupancy hotels and rooming houses shrank steadily due to gentrification and urban renewal (hasson and ley, ) . in this setting, the level of government support for subsidized rental housing plays a key role in determining the availability of units that a low-income individual or family can afford; the 's saw a decline in this support in both the u.s. and the united kingdom (cohen, ) . some have suggested that income distribution, specifically the ratio of middleincome to low-income households within a given city, is an important determinant of homelessness among both single adults and families (o'flaherty, ) . o'flaherty argues that because the construction of new rental housing for lowincome individuals is economically unattractive, the main source of housing for poor people is deteriorating housing stock that has been vacated by middle-income people. o'flaherty theorized that cities with fewer middle-class people relative to the number of poor people have higher rents at the bottom of the market (because middle-income housing is not being "handed down" to the poor), resulting in higher rates of homelessness. members of ethnic and racial minorities are disproportionately represented in the homeless population (e.g., blacks and latinos in the u.s., and aboriginal people in canada) (burt, ; hwang, ) . the higher prevalence of poverty in these disadvantaged groups may explain this observation. however, other race-related factors in the urban environment may contribute to the excess risk of homelessness among people of color, including discrimination in the housing market and segregation of low-income minorities in neighborhoods with fewer economic opportunities than neighborhoods in which low-income whites reside. any discussion of the role that urban poverty plays in causing homelessness also raises questions about nature of the causal relationship between homelessness and poor health. poverty is consistently and strongly associated with poor health (marmot, et al., ) . thus, the poor health observed among homeless people may be explained in large part by the fact that they experience extreme poverty and deprivation, rather than the fact that they happen to be homeless at the present time. this is particularly likely to be the case for individuals who have only recently become homeless, and less so for the chronically homeless, who have been subjected to the adverse health effects of lack of housing for a lengthy period. to extend this concept further, homelessness is a marker for severe poverty in the urban environment, and it may be this level of poverty, rather than the negative impact of homelessness itself, that has the greatest effect on population health in urban centers. this issue is discussed further in section of this chapter. social welfare systems in urban centers have a major impact on both the prevalence of homelessness and the health of homeless people. however, these systems are usually governed at the state or national level, rather than at the municipal level. wide variation is seen in the scope of social welfare programs, with more generous benefits typically seen in countries or regions that have less tolerance for high levels of income inequality and place a higher value on social cohesion (sleegers, b) . for example, eligibility criteria for welfare benefits in the u.s. vary significantly from state to state. some states allow single men to collect welfare, whereas others exclude them. these policies would likely affect the risk of homelessness among low-income single men living in any city within a given state. in addition, u.s. federal funds may not be used to provide temporary aid to needy families (tanf) if an adult in the family has received assistance for more than months, but individual states may elect to continue providing assistance to these families using state funds (state policy documentation project). in coming years, as families that are unable to become self-supporting begin reaching the -month federal time limits on benefits, their risk of becoming homeless may be greatly affected by the policies of the state in which they live. in contrast, most european union countries have extensive social welfare and public housing systems that make family homelessness less common. one area of controversy is whether the provision of cash entitlements or disability benefits has significant effects on the health of homeless people. on one hand, the health of homeless people should improve if public benefits allow them to obtain food, housing, and other essentials of life. on the other hand, increased income could be detrimental to health if the money is used to purchase alcohol or drugs. one of the few studies on this issue examined homeless mentally ill veterans who applied for social security disability insurance (ssdi) or supplemental security income (ssi). the individuals who were eventually awarded benefits did not differ in their past history of substance use from the individuals who were eventually denied benefits. three months after the decision to award or deny benefits, the group that was awarded benefits had significantly higher average total income (by $ per month) and higher quality of life than the group that was denied benefits. there was no evidence of increased alcohol or drug use or deterioration in psychiatric status among those who received benefits (rosenheck, et al., ) . most homeless people depend on their city's shelter system for housing, food, and other social services, and these shelters can therefore have a significant impact on the health of homeless people. the availability and quality of homeless shelters vary greatly. as noted previously, homeless people in cities with few shelter beds are more likely to live on the street or other places not intended for human habitation, with potentially adverse health effects. in addition, the staff at homeless shelters can play an important role in connecting homeless people to social services, job training, housing applications, and substance abuse treatment. the quantity and quality of food provided at shelters determines to a large extent the nutritional value of homeless people's diets, with potential downstream health effects (dachner and tarasuk, ) . finally, the physical environments at shelters range from extremely crowded, poorly ventilated, and unsanitary facilities to modern, clean, and well-run establishments. adverse shelter conditions have an impact on the transmission of tuberculosis and viral respiratory infections and the prevalence of health conditions such as skin infestations and asthma exacerbations. shelter conditions could also plausibly have an effect on mental and emotional well-being among residents. to date, however, little research has examined the effects of the physical shelter environment on the health of homeless persons, with the exception of the relationship between crowding and poor ventilation in shelters and the transmission of tuberculosis (advisory council for the elimination of tuberculosis, b). the organization and financing of the urban health care system has an enormous impact on the health of homeless people, and to some extent on the prevalence of homelessness as well. in the u.s., % of homeless people lack health insurance, creating a significant barrier to obtaining care (kushel, et al., ) . these individuals are dependent on state-or city-based systems designed to provide care for the indigent. in many large urban centers in the u.s., a designated public, county, or charity hospital provides the majority of hospital-based health care for homeless people. some cities have free-care clinics or community health centers that provide ambulatory services for homeless persons as well as other low-income residents. in u.s. cities, federally-funded health care for the homeless programs have established multidisciplinary teams of physicians, nurses, social workers, and outreach workers that provide care to homeless people on the street and in shelters. this limited set of health care providers is typically the only source of care available to homeless people in urban areas in the u.s., and the local funding and staffing level of these organizations is a critical determinant of access to health care. for homeless veterans, the proximity and availability of veterans health administration services is also an important factor. in countries such as canada and the united kingdom that have systems of universal health insurance, homeless people still face non-financial barriers to care. many access problems stem from the fact that a health care system designed to meet the needs of the general population may not accommodate the unique requirements of homeless people (crane and warnes, ; bugeja, a, b) . for example, the provision of universal health insurance does not necessarily result in the establishment of outreach programs for homeless people, appropriate treatment programs for homeless persons with mental illness or substance abuse, or an adequate supply of health care providers who are willing, able, and trained to work with this challenging population (buchanan, et al., ) . in the united kingdom, individuals must register with a general practitioner to obtain primary care, and some physicians are reluctant to accept homeless people into their practice because of their complex needs and the extra workload entailed (wood, et al., ) . health insurance does not protect against the fragmentation and discontinuity of care that homeless people often experience, nor does it eliminate the daily struggle to meet basic survival needs that may cause homeless people to place a lower priority on seeking health care (gelberg, et al., ) . inadequate access to primary health care may result in uncontrolled disease progression and frequent emergency department visits and hospitalizations (han and wells, ) . emergency department visits by homeless people should be seen as an indicator of high levels of unmet health needs, rather than inappropriate health care utilization (kushel, et al., ) . about % of homeless children with severe persistent asthma have had at least one emergency department visit in the last year, a finding indicative of inadequate access to health care and undertreatment of their disease (mclean, et al., ) . because individuals with severe mental illness who do not receive appropriate health care are at high risk of becoming homeless, the health care system can have a direct impact on the prevalence of homelessness. the role of deinstitutionalization in contributing to the problem of homelessness has been discussed extensively. beginning in the 's and 's, the advent of effective anti-psychotic medications to treat schizophrenia and an understandable desire to move people out of chronic mental hospitals, where conditions were sometimes horrendous, led to the discharge of tens of thousands of long-term psychiatric patients (dear and wolch, ; jencks, ) . the number of beds at psychiatric institutions fell precipitously. in theory, these patients were supposed to receive mental health care and social support in the community. in reality, many of these patients received little if any services and ended up swelling the ranks of the homeless population in the 's and 's. today, many decades after these events took place, "deinstitutionalization" is no longer the major cause of homelessness among people with serious mental illness. it is now uncommon for people with psychiatric disorders to have ever been institutionalized for an extended period, and any admissions tend to be quite brief. not surprisingly, individuals with severe illness, few social supports, and/or inadequate access to appropriate outpatient psychiatric care often become homeless. in a sense, homeless shelters have assumed the role that was played by chronic psychiatric hospitals fifty years ago. for these homeless people with severe mental illness, the delivery of appropriate health care is challenging but essential to improving their health and housing status. the assertive community treatment (act) model attempts to address this problem through a team of psychiatrists, nurses, and social workers who follow a small caseload of homeless mentally ill clients, seeking them out in the community to provide high-intensity mental health treatment and case management. studies have found that mentally ill homeless people receiving act spend fewer days hospitalized as a psychiatric inpatient and have somewhat greater improvement in symptoms than those receiving usual care (lehman, et al., ) . however, act is labor-intensive and costly, and its availability is often quite limited. the availability and type of addictive substances in the urban environment have an important effect on the prevalence of homelessness and on the health of homeless people (munoz, et al., ) . the advent of crack cocaine has been clearly implicated in the rise of homelessness in the u.s. in the 's (jencks, ) . in japan, alcoholism is the predominant addiction contributing to homelessness and morbidity among homeless people, whereas in the netherlands, homelessness is closely linked to chronic heroin addiction (takano, et al., a; sleegers, a) . access to addiction treatment is therefore a vital issue for a large proportion of homeless people. a number of treatment modalities for adults have been shown to be effective in controlled studies: admission to a post-detoxification stabilization program results in longer periods of abstinence than direct release into the shelter system (kertesz, et al., ) , and abstinence-contingent work therapy in a longterm residential setting has been shown to improve outcomes (milby, et al., ) . studies have examined the effectiveness of case management for homeless people with addictions, with mixed results (morse, ) . the forces underlying the urban geography of homelessness are aptly described in the seminal work of dear and wolch (dear, et al., ) . they examined how deinstitutionalization, rollbacks in entitlements to social assistance, and changes in the global economy in the late s and early s combined to create complex problems of poverty, inequality, and homelessness in north american cities that persist to this day. dear and wolch ( ) argued that these problems manifested themselves in the specific urban form of the "service-dependent ghetto," which refers to the spatial concentration in the inner city of service-dependent populations (such as people with mental illness, physical handicaps, addictions, or recent incarceration) and the organizations that assist them. while on one hand these can be characterized as areas of "urban blight," dear and wolch ( ) argued that they serve as a supportive environment and adaptive coping mechanism that can have a positive effect on the health and well-being of residents who have few other options. servicedependent ghettos are often the object of antagonism from surrounding communities. paradoxically, however, these more affluent communities often perpetuate the forces that create the service-dependent ghetto and entrench processes of inner-city decay through citizen resistance to housing and services for low-income people and exclusionary land use policies and zoning practices (dear and taylor, ) . in some cities, the tendency has been to isolate high-poverty urban neighborhoods rather than attempt to destroy them. davis argues that in los angeles and other cities, a conscious effort has been made to create geographic and physical barriers (such as expressways) that circumscribe poor and minority neighborhoods and cut them off from the rest of the city (davis, ) . this spatial isolation can further heighten the marginalization of these communities and limit residents' access to goods, services, and economic opportunities that are vital to health. since homeless people spend a great deal of their time in public spaces, the nature of these spaces can have a significant impact on their quality of life. some cities have numerous well-tended public spaces such as parks and squares that are conducive to those who wish to linger or rest, including homeless people. these spaces can serve a socially cohesive function if urban dwellers of diverse backgrounds perceive them to be safe "neutral" spaces in which to gather and socialize. in contrast, other cities have built environments that lack such public spaces and are instead dominated by privatized quasi-public spaces such as shopping malls. nonpurposeful lingering, which would be generally acceptable in a public space such as a park, is perceived as "loitering" in such places. in a relatively trivial but very specific expression of hostility toward homeless people, some cities have installed "bum-proof" benches that are designed to prevent reclining or sleeping on the seat. while these elements of the urban environment seem relatively minor, they may reflect a city's prevailing sentiment towards homeless and poor people that sets the tone of their daily existence (davis, ). homelessness is often perceived as having a negative effect on the quality of life in urban centers. some consider the visible presence of homeless people in parks, street corners, and other public spaces to be a manifestation of "urban disorder" and a barrier to the successful promotion of commerce and tourism. in response to these concerns, a number of cities have enacted by-laws against panhandling, loitering or sleeping in public places, public intoxication, or possession of shopping carts. some cities have instituted aggressive policing strategies to remove homeless people from public spaces (graser, ) . efforts to displace street youth and homeless people rather than offer them any meaningful help might have negative effects on health and in fact increase high-risk behaviors such as survival sex and unsafe injection drug use practices (o'grady and greene, ; wood, et al., ) . homeless people frequently interact with both police and paramedics, but they have much lower levels of trust in police than in paramedics (zakrison, et al., ) . by inhibiting homeless people from calling for needed emergency assistance, this distrust could result in serious harms to health. in a study of injection drug users in san francisco, % of those who had been present with an unconscious heroin overdose victim did not call for emergency services due to fear of police involvement (davidson, et al., ) . police action can also have direct adverse effects on the health through the excessive use of force (cooper, et al., ) . in a study in toronto, % of homeless people reported having been assaulted by a police officer in the last months (zakrison, et al., ) . on a larger scale, issues of urban governance such as fiscal disparities affect all urban dwellers, but have the potential to have a particularly severe impact on homeless and poor people. fiscal disparities typically occur when an older central city with a significant number of high-poverty neighborhoods is surrounded by a ring of higher-income municipalities. the central city's primary revenue stream from property taxes is limited by a weak tax base, but at the same time the city is confronted by a high and rising demand for social services, some of which is driven by the downloading of 'unfunded mandates' by states onto central city municipalities (drier, et al., ) . meanwhile, the nearby ring communities have a strong property tax base and face a lower demand for social services, while at the same time its residents work in the central city and benefit from its economic activities and services (the socalled "free-rider" effect) (orfield, ; drier, et al., ) . these fiscal disparities greatly exacerbate the adverse effects of racial and economic segregation on homeless people and others living in extreme poverty in the central city. in an example of an effort to redress this problem, state legislation in minnesota, the fiscal disparities act, mandates the sharing of commercial property tax between outlying, high tax base municipalities to central city municipalities to assist in the provision of social services. enacted in by the minnesota legislature, the plan pools % of the increase in all communities' commercial/industrial property valuation. all cities and townships keep their pre- tax bases plus % of the annual growth. the pool is then taxed at a uniform rate and redistributed among all local government entities. although this redresses some of the intrametropolitan disparities, it does little to reduce the payoffs of "externalizing" social problems with tools like exclusionary zoning in typically more affluent communities. moreover, the minneapolis-st. paul example depends on the existence of a strong regional-metropolitan level of governance, the met council, which although heavily studied (orfield, ; rusk, ; katz and bradley, ) , is still a concept that is strongly resisted by homeowners' associations, gated communities, and affluent municipalities (mckenzie, ; boudreau and keil, ). an alternative solution is to create cities that encompass lower and higher income areas, rather allowing them to separate into different jurisdictions. in toronto, ontario, this was effectively accomplished through the amalgamation of five contiguous cities into a single urban entity, although the amalgamation was motivated by a desire to increase operating efficiency rather than concern regarding fiscal disparities (boudreau, ) . does homelessness have a sizeable effect on population health? this question raises a number of complex issues. homeless people, especially those who are chronically homeless, tend to have poor health. however, homelessness is a temporary state, not a permanent trait. as many as millions americans experience homelessness over a five year period, but most of these episodes of homelessness are quite brief (link, et al., ) . thus, at any single point in time only a very small proportion of a city's population is without a home. homeless people would therefore be expected to have a minimal impact on indicators of overall population health, such as health status or mortality rates. of course, this assumption may be incorrect in urban centers in the developing world, where extremely large numbers of people often live on the street or in encampments. some have suggested that homelessness may have an adverse effect on public health through the spread of infectious diseases, such as tuberculosis. compared to the general population, homeless people are clearly at increased risk of developing latent tuberculosis, which is not infectious to others, as well as active tuberculosis, which can infect those who come in close contact with the individual. during tuberculosis outbreaks, shelter residents, shelter staff, and health care providers are at increased risk of becoming infected (advisory council for the elimination of tuberculosis, a). to date, however, outbreaks of tuberculosis among homeless people have not spread widely within the general population. the threat of tuberculosis is therefore an important health problem for homeless people, but one that has demonstrated relatively limited potential to affect overall population health in urban areas. the outbreak of severe acute respiratory syndrome (sars) in has raised the specter of rapid and uncontrolled spread of acute respiratory infections through the homeless population. the sars outbreak in toronto was almost entirely confined to travelers returning from abroad, health care workers, and their household contacts (svoboda, et al., ) . no homeless person became infected with sars. if this had happened, the large, transient, and difficult-to-locate shelter population would have made it almost impossible for toronto public health officials to implement their core strategy of identifying and quarantining all "household contacts" of patients with sars. such a situation could have had devastating effects on efforts to prevent the outbreak from spreading into the city's general population. given the threat of a recurrence of sars or the possible emergence of other new and potentially deadly respiratory infections, infection control measures to deal with a severe acute infectious disease outbreak in the homeless population require serious consideration. although this scenario is currently hypothetical, the potential implications for population health are considerable. homelessness may have major implications for population health, for reasons other than those discussed above. emphasis on the direct impact of homelessness on population health may be misplaced. instead, homelessness may be viewed as a sentinel event, a marker for dysfunction in multiple sectors including the housing market, job market, health care system, and social welfare system. homelessness represents the extreme end of a larger distribution of socioeconomic status and housing status, and it attracts attention precisely because of its dire nature. this conceptualization has been well-described in work by rose ( ) . as shown in figure , the curve shown with a solid line represents the distribution of housing quality within a hypothetical population. homelessness represents the extreme low point along the dimension of housing quality. this approach views one's housing situation as a continuum and avoids creating a simple dichotomy between being homeless and being housed. for the sake of this discussion, we assume that housing conditions have an impact on health, an assertion for which there is ample support (fuller-thomson, et al., ; krieger and higgins, ) . figure also illustrates two different approaches to improving health through improving housing conditions. the greatest effect in terms of population health may be gained through approach a (shifting the entire population distribution for the factor upwards slightly, to the distribution curve indicated by a dotted line) rather than approach b (focusing on improving conditions for the highest-risk group at the worst extreme of the distribution). a similar argument could be applied to the relationship between poverty and health, where the x-axis on the diagram would represent income rather than housing quality. the case of asthma is an excellent example of this dilemma. about % of children staying at homeless shelters in new york city have asthma (mclean, et al., a) . although this is a disturbingly high rate, the prevalence of asthma is also very high among inner-city children living in substandard housing (malveaux and fletcher-vincent, ) . because homeless children represent a relatively small proportion of all children living in poverty in a given city, the population health effect of asthma among homeless children is likely to be far smaller than the population health effect of asthma in the much larger number of children who are housed but living in decrepit buildings. while homeless children are a distressing manifestation of urban poverty, they represent "the tip of the iceberg" of the broader issue of poverty and poor housing. thus, the problem of asthma among homeless children may be regarded as an extreme example of a much larger population health concern that may be a more appropriate target for intervention. a consideration of strategies to improve the health of homeless people raises the question of whether our first concern should be to attempt to deal with the problem of homelessness itself, or to intervene to relieve illness among homeless youths, single adults, or families. of course, this is not an either/or proposition. nonetheless, an excessive emphasis on the latter approach might result in producing healthier homeless people, yet fail to recognize that homelessness is the result not only of individual vulnerabilities, but also of deeper structural problems within our society. on the other hand, a focus on the former approach may founder on the assumption that providing homeless people with stable housing will necessarily improve their health. an example of this tension is the emergence of two contrasting service delivery models to meet the needs of chronically homeless adults with concurrent mental illness and substance abuse (tsemberis, et al., ; hopper and barrow, first model, known as the "continuum of care," attempts to move homeless people from the street into transitional congregate housing, in conjunction with a requirement that the individual engage in treatment for their mental illness and addictions. under this model, the person is allowed to make the transition to permanent housing only after they achieve abstinence from alcohol and drugs and their clinical status has been stabilized. in contrast, the "housing first" model is based on the belief that homeless people should be afforded permanent housing as a basic human right, not as a reward contingent on participating in treatment. in this model, homeless people can obtain housing in individual apartments without any preconditions, and they are then offered an array of harm reduction and treatment services through an act team (see section . . above). a recent randomized controlled trial assigned homeless adults with concurrent severe mental illness and substance abuse to one of these two approaches. individuals treated under the "housing first" model spent significantly less time homeless over the follow-up period, and at the end of months about % were in stable housing as compared to only % in the "continuum of care" model. however, there were no significant differences between the two groups in terms of alcohol use, drug use, or psychiatric symptoms. this study highlights the need to acknowledge that ending homelessness is a worthwhile goal in and of itself, but that it is not synonymous with improving the health of homeless people. other strategies include adapting the health care system to better meet the unique needs of homeless adolescents, single men and women, or families. as discussed in section . above, a cornerstone of this effort is the use of multidisciplinary teams providing coordinated care at outreach sites, in combination with more traditional clinic-based health care services. for homeless people with severe mental illness, the availability of act services is vital, but the effectiveness of less resource-intensive systems of mental health care for homeless people needs to be assessed. for those with addictions, the availability of detoxification beds, postdetoxification stabilization programs, and longer-term ( to month) residential addiction treatment programs are important issues. in designing these services, the heterogeneous needs of different subgroups of homeless people (e.g., street youth, single men, single women, and mothers with young children) must be taken into account. while improving conditions at shelters is by no means the preferred route to better health for homeless people, it is important that shelters not contribute to ill health. certainly, the availability of adequate capacity to accommodate everyone who seeks a shelter bed is a reasonable first step towards protecting homeless adults from the elements. adherence to basic standards of cleanliness, nutrition, and food hygiene within shelters and the avoidance of overcrowding and inadequate ventilation are mandatory. perhaps equally important is the creation of a safe and welcoming environment that encourages clients to engage with service providers. at a broader level, interventions are needed to decrease the prevalence of homelessness and address the systemic issues that contribute to homelessness. these efforts may at least in some cases have health benefits as well. for homeless families, there is compelling evidence that the provision of subsidized housing is both necessary and sufficient to end their homelessness (shinn, et al., ) . the "housing first" strategy appears to be more effective in moving homeless people with concurrent mental illness and substance abuse into stable housing; further research is needed to examine the effectiveness of this approach with other subgroups of homeless people. serious attention needs to be paid to the impact of the social welfare system on homelessness and health. restrictions in eligibility for temporary aid for needy families and state-run welfare programs threaten to contribute to a potential rise in homelessness among families and single adults in coming years. further research is needed in this area and on the impact of receipt of welfare or disability benefits on the health of homeless people. finally, upstream from the distinctive and visible issue of homelessness is the larger problem of urban poverty. the existence of entire communities and groups who are cut off from a decent education, employment opportunities, housing, and access to health care should raise extremely troubling questions for anyone who cares about the health of our urban centers. while the adverse health effects of homelessness are clearly severe, this phenomenon is only a specific and extreme example of the larger problem of the effects of poverty and inadequate housing on population health. prevention and control of tuberculosis among homeless persons. recommendations of the advisory council for the elimination of tuberculosis prevention and control of tuberculosis among homeless persons. recommendations of the advisory council for the elimination of tuberculosis hiv infection among homeless adults and runaway youth foci of tuberculosis transmission in central los angeles mortality among homeless shelter residents in new york city determinants of behavior in 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homeless and non-homeless women sex workers in public health measures to control the spread of the severe acute respiratory syndrome during the outbreak in toronto identification of cardiovascular risk factors in homeless adults disease patterns of the homeless in tokyo disease patterns of the homeless in tokyo accidental hypothermia and death from cold in urban areas psychiatric disorders in homeless men and women in inner sydney housing first, consumer choice, and harm reduction for homeless individuals with a dual diagnosis reaching homeless youths for chlamydia trachomatis and neisseria gonorrhea screening in denver mental health problems of homeless children and families: longitudinal study hiv risk profile and prostitution among female street youths when work disappears: the world of the new urban poor. random house the truly disadvantaged : the inner city, the underclass, and public policy displacement of canada's largest public illicit drug market in response to a police crackdown do the homeless get a fair deal from general practitioners? outcomes of contact investigation among homeless persons with infectious tuberculosis homeless people's trust and interactions with police and paramedics key: cord- -z m dur authors: ki, jison; ryu, jaegeum; baek, jihyun; huh, iksoo; choi-kwon, smi title: association between health problems and turnover intention in shift work nurses: health problem clustering date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: z m dur shift work nurses experience multiple health problems due to irregular shifts and heavy job demands. however, the comorbidity patterns of nurses’ health problems and the association between health problems and turnover intention have rarely been studied. this study aimed to identify and cluster shift work nurses’ health problems and to reveal the associations between health problems and turnover intention. in this cross-sectional study, we analyzed data from nurses who worked at two tertiary hospitals in seoul, south korea. data, including turnover intention and nine types of health issues, were collected between march and april . hierarchical clustering and multiple ordinal logistic regressions were used for the data analysis. among the participants, . % expressed turnover intention and the mean number of health problems was . (range – ). using multiple ordinal logistic regressions analysis, it was shown that sleep disturbance, depression, fatigue, a gastrointestinal disorder, and leg or foot discomfort as a single health problem significantly increased turnover intention. after clustering the health problems, four clusters were identified and only the neuropsychological cluster—sleep disturbance, fatigue, and depression—significantly increased turnover intention. we propose that health problems within the neuropsychological cluster must receive close attention and be addressed simultaneously to decrease nurse’s turnover intentions. nurses often work irregular shifts and bear high physical and psychological job demands that may, in turn, jeopardize their health status. specifically, shift work may cause a variety of physical and mental health problems [ ] . the deterioration of nurses' health status could not only lead to a decline in their quality of life but could also affect the quality of care provided by them [ ] . in addition, health problems may affect nurses' turnover, which is a serious issue worldwide [ ] . the high turnover rate of nurses has led to an increase in both direct and indirect costs in the health system and could further protract the shortage of nurses that has lasted for the past several years [ ] . a recent survey of korean nurses reported that about % of shift work nurses cited health problems as their main reason for resigning [ ] . prior studies also show that nurses complained of two or more health problems simultaneously, which may be interrelated [ , [ ] [ ] [ ] . musculoskeletal pain in nurses has been reported in many studies [ , ] , and poor dietary habits due to irregular shift work were reported to cause gastrointestinal disorders [ , ] . sleep disturbance, which is most frequently reported in studies of shift nurses, could lead to mood disorders, such as depression, both of which lead to chronic fatigue [ ] [ ] [ ] . although nurses experience various health problems, there is relatively little research on the relationships between complex health problems in nurses [ ] . moreover, few studies have investigated the relationship between concomitant health problems and turnover intention. because the burden may vary depending on the number and the kind of health problems shift work nurses have [ ] , it may be important to identify specific comorbidity patterns of nurses' health problems through clustering and determine which clusters most affect turnover intention, where a cluster-that is, a comorbid pattern of health problems-can be defined as a group of concurrent or related health problems that can be distinguished from other clusters [ ] . therefore, the purpose of this study was to first characterize shift work nurses' health problems. we then determined the pattern of symptom modalities by clustering the health problems through the hierarchical clustering method. lastly, we identified the impact of health problem clusters on turnover intention. this cross-sectional study was part of the shift work nurses' health and turnover (swnht) study, which is a prospective cohort study designed to investigate the longitudinal relationships between shift work nurses' health and turnover. it was supported by the national research foundation of korea (nrf) grant funded by the korea ministry of science and information and communications technologies and approved by the institutional review board (irb) at two tertiary hospitals in seoul, south korea. data collection was performed from march until april . in the swnht study, we recruited female nurses ( novice nurses who had no exposure to rotating shift work, and nurses with exposure to -hour rotating work, including night shifts, for at least month) ( figure ). because health problems can vary according to sex [ , ] and the swnht study included a survey of nurses' menstrual and gynecological symptoms, the swnht study was limited to female nurses. data were collected three times for novice nurses: before exposure to shift work (novice registered nurse (nrn) t , n = ), after six months of work (nrn t , n = ), and months after t (nrn t , n = ). for experienced registered nurses, data were collected twice: baseline (experienced registered nurse (ern) t , n = ) and months after t (ern t , n = ; see details in section . data collection). int. j. environ. res. public health , , x of could lead to mood disorders, such as depression, both of which lead to chronic fatigue [ ] [ ] [ ] . although nurses experience various health problems, there is relatively little research on the relationships between complex health problems in nurses [ ] . moreover, few studies have investigated the relationship between concomitant health problems and turnover intention. because the burden may vary depending on the number and the kind of health problems shift work nurses have [ ] , it may be important to identify specific comorbidity patterns of nurses' health problems through clustering and determine which clusters most affect turnover intention, where a cluster-that is, a comorbid pattern of health problems-can be defined as a group of concurrent or related health problems that can be distinguished from other clusters [ ] . therefore, the purpose of this study was to first characterize shift work nurses' health problems. we then determined the pattern of symptom modalities by clustering the health problems through the hierarchical clustering method. lastly, we identified the impact of health problem clusters on turnover intention. this cross-sectional study was part of the shift work nurses' health and turnover (swnht) study, which is a prospective cohort study designed to investigate the longitudinal relationships between shift work nurses' health and turnover. it was supported by the national research foundation of korea (nrf) grant funded by the korea ministry of science and information and communications technologies and approved by the institutional review board (irb) at two tertiary hospitals in seoul, south korea. data collection was performed from march until april . in the swnht study, we recruited female nurses ( novice nurses who had no exposure to rotating shift work, and nurses with exposure to -hour rotating work, including night shifts, for at least month) ( figure ). because health problems can vary according to sex [ , ] and the swnht study included a survey of nurses' menstrual and gynecological symptoms, the swnht study was limited to female nurses. data were collected three times for novice nurses: before exposure to shift work (novice registered nurse (nrn) t , n = ), after six months of work (nrn t , n = ), and months after t (nrn t , n = ). for experienced registered nurses, data were collected twice: baseline (experienced registered nurse (ern) t , n = ) and months after t (ern t , n = ; see details in section . . data collection). in this study, we used data collected from october to january (nrn t , n = ) and from march to may (ern t , n = ) to analyze the association between health problems and turnover intention among shift work nurses. in this analysis, we defined shift work as a in this study, we used data collected from october to january (nrn t , n = ) and from march to may (ern t , n = ) to analyze the association between health problems and turnover intention among shift work nurses. in this analysis, we defined shift work as a combination of day, evening, and night shifts; therefore, we excluded four nurses, including three nurses who worked only daytime hours and one nurse who worked from midday to p.m. the primary purpose of the swnht study was to investigate health problems, presenteeism, and turnover intention in shift work nurses. to enroll novice nurses without shift work experience, we distributed and collected survey envelope packages that included survey instructions, consent forms, and a questionnaire on the third day of their work orientation before ward placement. to enroll experienced shift work nurses, we attached a recruitment notice to the ward bulletin boards, and nurses who wished to participate in the study voluntarily contacted the research team. we maximized voluntary participation by protecting confidentiality, ensuring anonymity, and no hospital-associated researchers took part in the data collection process. we collected the follow-up data through an online survey program; their response rates were . % (nrn t , nrn t ) and . % (ern t ). the swnht study questionnaire included questions regarding general and job-related characteristics, health-related variables (e.g., dietary habits, menstrual symptoms, exposure to blood and body fluid, sleep, fatigue, depression, physical activity, etc.), occupational stress, presenteeism, and turnover intention. to objectively verify the sleep scale data, we also obtained actigraphy data from the subjects who consented to wear the actigraphy. the examined demographic characteristics included age (years), education (bachelor's degree or lower/master's degree or higher), marital status (single/married), having children (yes/no), and body mass index (kg/m ). the examined job-related characteristics included work unit (general ward, intensive care unit, delivery room, and emergency room), months of shift work experience, and the average number of night shifts per month. we measured turnover intention since it is the most predictive measure of actual turnover [ ] . in a longitudinal study in europe, nurses who had turnover intentions were more likely to leave their jobs [ ] . in this study, the subjects were asked to choose one of four options (strongly agree, agree, disagree, or strongly disagree) to answer the question: "i plan on staying for the next year" [ ] . the nine health problems in this study were selected by two professors at a nursing college and two nurses in a research team, and were based on reviews of the literature about shift work nurses' health problems [ , , [ ] [ ] [ ] [ ] [ ] . these were ( ) upper musculoskeletal pain (including neck, shoulder, and back pain), ( ) leg or foot discomfort, ( ) sleep disturbance, ( ) fatigue, ( ) depression, ( ) menstrual disorders (including dysmenorrhea and menopause symptoms), ( ) gynecological disorders (including disease of the uterus or ovary), ( ) headaches (including migraine, dizziness, and chronic headaches), and ( ) gastrointestinal disorders (including gastric ulcer, diarrhea, constipation, and stomachache). among the nine health problem categories, sleep disturbance, fatigue, and depression were measured using the instruments described below. for the other six health problem categories, the subjects were asked to indicate the health problems they experienced during the last month with "yes" or "no." to assess the quality of sleep, we used the korean version of the insomnia severity index (isi), which was developed by morin and translated by the korean sleep research society. the insomnia severity scale consists of seven questions related to sleep disorders measured on a -point scale ( - points) for each item. the score ranges from to ; higher scores indicate a lower quality of sleep. a score above indicates sleep disturbance [ ] . the cronbach's alpha value of the korean version of isi was . in our study. fatigue was measured using the fatigue severity scale (fss). the fss consists of nine questions about the degree of fatigue during the past week and is scored from (strongly disagree) to (strongly agree). a higher average score indicates higher fatigue. the criterion for fatigue is more than four points on average [ ] . the cronbach's alpha value of the fss was . in our study. we measured depression using the shortened center for epidemiological studies depression scale (ces-d). the shortened ces-d consists of questions about depressive feelings and thoughts during the past week and is scored from (less than day) to (about - days). higher total scores indicate more depressive symptoms. a total score of or above indicates depression [ ] . the cronbach's alpha value of the shortened ces-d was . in our study. all analyses were performed using sas version . (sas institute inc., cary, nc, usa) and r project for statistical computing software version . . (cran, soule, korea). we confirmed that there were no missing data. the descriptive statistics (frequency, percentage, mean, and standard deviation) for the demographic characteristics were analyzed. pearson's chi-squared test, fisher's exact test, and an analysis of variance were used to identify general characteristics associated with turnover intention. hierarchical clustering was used to group the health problems reported by participants. hierarchical clustering is a statistical method for grouping objects or variables according to the similarity between clusters using a bottom-up approach. in the field of nursing, this technique has been used mainly for symptom clustering of cancer patients; however, it has recently become more widely used in various studies [ ] . the method used for measuring the distance between variables was the squared euclidean distance and the linkage method used for measuring the distance between clusters was the average linkage. the number of final clusters is usually determined by the researchers by taking into account clinical suitability [ ] . multiple ordinal logistic regressions that included covariates, such as education, marital status, having children, body mass index (kg/m ), work unit, months of shift work experience, and the number of night shifts per month, was used to investigate the association of single health problems and clusters of health problems with turnover intention. the four categories of "strongly agree," "agree," "disagree," and "strongly disagree" used for the turnover intention variable satisfied the proportional odds assumption at p > . with the covariates and variables of interest. this study was approved by the institutional review board (irb) at seoul national university hospital (irb no. h- - - ) and the samsung medical center (irb no. - - - ). after agreeing to participate in the study, all nurse participants signed a consent form and completed the baseline questionnaire. the participants were female nurses working shifts, including night shifts. the nurses' mean age was . years (standard deviation (sd) = . ), and . % were over years old. there were no differences in demographic and job-related characteristics between the participants in the two tertiary hospitals. most nurses were single ( . %) and had no children ( . %). the average body mass index (bmi) was . kg/m ; . % of the subjects were underweight and only one subject was obese. the shift work length was months on average, which was highly correlated with age (r = . , p < . ). therefore, we excluded age from the covariates of the multiple ordinal logistic regressions (table ) . one hundred and eleven nurses ( . %) had a turnover intention and nurses ( . %) strongly intended to leave. the turnover intention was statistically higher in subjects who were younger (f = . , p = . ), had no children (χ = . , p = . ), had a lower bmi (f = . , p = . ), and had shorter periods of shift work (f = . , p < . ). the mean number of health problems was . (range - ), with . % (n = ) of participants having more than two health problems. the most frequently reported health problem was upper musculoskeletal pain ( . %), followed by leg or foot discomfort ( . %), fatigue ( . %), and sleep disturbance ( . %). the associations between single health problems and turnover intention using multiple ordinal logistic regressions are provided in table . fatigue (odds ratio (or) = . , % confidence interval (ci) = . - . ), depression (or = . , % ci = . - . ), leg or foot discomfort (or = . , % ci = . - . ), sleep disturbance (or = . , % ci = . - . ), and a gastrointestinal disorder (or = . , % ci = . - . ) were significantly related to turnover intention. based on the hierarchical clustering analysis, four clusters were identified ( figure ): the pain cluster (upper musculoskeletal pain and leg or foot discomfort), the neuropsychological cluster (depression, sleep disturbance, and fatigue), the gynecological cluster (menstrual disorder and gynecological disorder), and the gastrointestinal cluster (headache and gastrointestinal disorder). as a result of our multiple ordinal logistic regression analyses, only the neuropsychological cluster (depression, sleep disturbance, and fatigue) was found to be significantly related to turnover intention. in the neuropsychological cluster, if the participant had only one health problem, it did not relate to turnover intention. if the participant experienced two (or = . , % ci = . - . ) or three (or = . , % ci = . - . ) health problems in the cluster simultaneously, the odds ratio of the turnover intention increased linearly, which was statistically significant (f = . , p < . ; table ). based on the hierarchical clustering analysis, four clusters were identified (figure ): the pain cluster (upper musculoskeletal pain and leg or foot discomfort), the neuropsychological cluster (depression, sleep disturbance, and fatigue), the gynecological cluster (menstrual disorder and gynecological disorder), and the gastrointestinal cluster (headache and gastrointestinal disorder). we investigated the prevalence of shift work nurses' health problems and characterized the patterns of symptom modalities by clustering health problems. we then investigated the association of single health problems and clusters of health problems with turnover intentions. we found that most shift work nurses experienced multiple health problems at the same time. we also found that having more than two health problems in the neuropsychological cluster was significantly related to turnover intention. this study was the first to attempt the clustering of nurses' health problems and explore the relationship between the clusters and turnover intention in shift work nurses. we found that . % of nurses had turnover intention. in previous studies, turnover intention varied from % to % [ ] [ ] [ ] . the first reason for the difference in turnover intention between existing studies and our study could have been the different measurement tools used in each study. while our study asked about future plans regarding turnover, such as "i plan on staying for the next year," other studies asked how often they thought about turnover in the past [ , ] . some studies measured turnover intention with various questions, such as whether they were seeking another job or whether they thought about leaving the nursing profession forever [ , ] . the second reason that turnover intention in our study was higher than in previous studies may be due to different hospital environments. the hospitals where our study was performed were tertiary hospitals in seoul, which had a higher patient severity and higher nurse labor intensity than other hospitals in korea. third, we measured turnover intention and not actual turnover, which is reported to be higher than actual turnover rates [ ] . in , the annual average nurse turnover rate was . % in korea [ ] . we found that fatigue was common in our subjects, highly related to turnover intention, and had the highest odds ratio (or = . , % ci = . - . ). our results were consistent with a previous study that reported a positive correlation between fatigue and turnover intention [ ] . although we could not determine with certainty how long they had suffered from fatigue, it appeared that fatigue was one of the common disabling health problems that lead to turnover intention. fatigue may exert a direct effect on turnover intention since nurses' fatigue has been reported to interfere with work efficiency and concentration and increase the risk of medical error and injury [ , ] . although the direction of causality was not identified, nurses' fatigue was reported to be related to sleep disturbance, poor health, and depression [ , ] . not surprisingly, we found that about % of nurses complained of fatigue and sleep disturbance at the same time and sleep disturbance was associated with turnover intention as a single health problem (or = . , % ci = . - . ). sleep disturbance has received the most attention as a cause of turnover intention among nurses' health problems [ , ] . irregular and insufficient sleep time due to shift work may often cause sleep disturbance, which may affect nurses' physical and mental health [ ] . another finding of interest was that about % of nurses had all three interrelated symptoms of fatigue, sleep disturbances, and depression; this was associated with turnover intention as a single health problem (or = . , % ci = . - . ). depression in nurses is prevalent in many studies, and in one study, the prevalence of depression among nurses was almost twice as high as in other professions [ , , ] . depression may decrease concentration, which reduces the productivity of nursing and affects nurses' judgment, thus increasing occupational injury and turnover intention [ , ] . our study revealed that fatigue, sleep disturbance, and depression may play important roles in increasing turnover intention as a cluster and as individual symptoms. approximately one-third of nurses experienced all three health problems; these findings suggest fatigue, sleep disturbance, and depression in the neuropsychological cluster were correlated with each other. despite the fact that biological and behavioral mechanisms in the development of depression, fatigue, and sleep disturbances are unknown, several studies have reported that these three health problems are related and co-occur [ , ] . most importantly, % of nurses experienced one or more health problems in the neuropsychological cluster and this cluster was associated with turnover intention. moreover, their odds ratio of turnover intention increased linearly as the number of health problems increased within this cluster. future studies should probe the comorbidity of sleep disturbance, depression, and fatigue of shift work nurses and develop comprehensive health promotion to alleviate these three health problems. we found that having a gastrointestinal disorder was another common health problem, which was consistent with the result of a previous study of , korean nurses [ ] . this high prevalence of gastrointestinal disorders among shift work nurses may, first, be due to disturbed circadian rhythm. the gastrointestinal system, like sleep, has a circadian rhythm, which controls bowel movement and the secretion of gastric juices [ ] . second, it might be due to irregular meal times and skipped meals [ ] . although not shown in the result, most of the nurses in our study reported eating irregularly ( . %) and they ate breakfast twice a week, which was lower than the average number of times korean adults eat breakfast [ ] . the most common reason for skipped meals in our study was irregular work times ( . %). considering that having a gastrointestinal disorder was common among shift work nurses and was a single health problem that increased turnover intention, special attention needs to be paid to having regular and sufficient mealtimes as much as possible. in our results, gastrointestinal disorders and headaches formed the gastrointestinal cluster. this connection could be explained by the association between the brain and the stomach through neural, endocrine, and immune pathways and the high prevalence of headaches in patients with a gastrointestinal disorder [ , ] . however, the gastrointestinal cluster was not related to turnover intention. it is possible that headaches, as an individual health problem, had no significant association with turnover intention, which could have decreased the effect of the cluster. furthermore, we presume that headaches as a single health problem were not shown to be associated with turnover intention because headaches are often easily relieved by medication and may not have been as severe as a gastrointestinal disorder. upper musculoskeletal pain, which had the highest prevalence, formed a pain cluster with leg or foot discomfort. nurses work most of the time in a standing position, walking an average of steps ( . miles) per shift [ ] , and high physical demands have been associated with musculoskeletal problems in nurses [ ] . additionally, multi-site musculoskeletal pain has been shown to be more common than single-site pain, especially in women [ ] . unexpectedly, this cluster was not related to turnover intention, although leg or foot discomfort was related to turnover intention. this might be because most nurses ( %) suffered upper musculoskeletal pain regardless of turnover intention and, similar to the gastrointestinal cluster, the association of the pain cluster with turnover intention was reduced by the effect of upper musculoskeletal pain. although the pain cluster did not relate to turnover intention, given that these health problems in the pain cluster had a high prevalence and cause sickness and absence from work and decreased work productivity [ ] , there is a need to investigate the prevalence of musculoskeletal disorders in nurses by workplace and to provide appropriate prevention and treatment programs. although our study provides a new perspective on nurses' health problems, it has some limitations. first, this study relied on self-report measures of health problems, except for three health problems (sleep disturbance, depression, and fatigue). second, we surveyed only the presence of health problems, but not the severity; however, as the participants were nurses with medical knowledge, their judgment of the presence of health problems might be more reliable than that of the general public [ ] , which would partially compensate for the fact that some health problems were not assessed with standardized tools. third, we could not infer the causal relationship from the cross-sectional design of the study. the fourth significant limitation is that this study did not measure how many nurses actually leave their job; therefore, the findings of our study may not apply to actual turnover, as turnover intention does not always lead to actual turnover. fifth, the shift work nurses who participated were all female and from two tertiary hospitals in seoul in korea. therefore, the generalizability of the results is limited. future studies on the comorbidity of sleep disturbance, depression, and fatigue in shift work nurses from various hospitals in various regions, along with the inclusion of male nurses, are recommended. in this study, the association of single health problems and clusters of health problems with turnover intention differed. although fatigue, sleep disturbance, depression, gastrointestinal disorders, and leg or foot discomfort were related to turnover intention as single health problems, after clustering, only the neuropsychological cluster-including fatigue, sleep disturbance, and depression-was related to turnover intention. given that nurses had more than two health problems and turnover intention increased linearly within the neuropsychological cluster, these problems must receive close attention 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uk population study the nurses' health study: lifestyle and health among women this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license key: cord- -dxu ajse authors: kim, sookyung; lee, hyeonkyeong; lee, hyeyeon; loan, bui thi thanh; huyen, le thi thanh; huong, nguyen thi thanh title: prioritizing training needs of school health staff: the example of vietnam date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: dxu ajse competencies of school health staff (shs) members, including school nurses, are crucial to improving child and adolescent health. in vietnam, although shs members are dispatched to schools, they have limited training opportunities. this study identified shs members’ training needs in a province of vietnam. a cross-sectional, online survey was conducted with shs members. the performance and importance of shs members’ competencies were measured using -items and rated by a -point likert scale. shs members’ training priorities were analyzed using the borich needs assessment and the locus for focus model. controlling infectious disease was the highest training priority while implementing health promotion programs was of relatively low priority. the high-priority training needs identified could be rendered mandatory in policy for continuing education of shs members. awareness of the importance of health promotion, which has been emphasized globally, should also be promoted via school health policy. these findings could guide development of future training programs for shs members. establishing children and adolescents' engagement in self-care is crucial to ensure their health in adulthood and ultimately reduce global health inequality [ ] . earlier studies have provided evidence that risky behaviors established during adolescence can continue into adulthood, thereby becoming several leading causes of mortality and morbidity [ ] . attention has been directed toward adolescence in low-and middle-income countries (lmics) as part of their commitment to achieve the sustainable development goals (sdgs) of ensuring healthy lives and promoting well-being for all, at all ages, and decreasing the incidence of non-communicable diseases, which represents the leading cause of preventable mortality [ ] . as schools provide care and education for students for long periods, school is an important setting within which to promote adolescents' health [ ] . well-designed school-based health interventions enable students to build competencies to prevent disease and promote health [ , ] . however, the school health staff (shs) members responsible for school health service and education in lmics have limited capacity. therefore, global collaborative efforts are essential to improve key human resources on the frontline of ensuring students' health; implementation of best practices across countries could represent an improved strategy. shs members play a key role in identifying unmet health needs of school-aged children and promoting health in schools. it is essential to strengthen the ability of shs members to perform their roles adequately. shs members in lmics rarely have opportunities to engage in systematic education and training, and there is considerable variation in their competency [ ] . in many countries, school nurses play an important role in promotion and prevention programs for school health, but in lmics, the proportion of shs members who are skilled health professionals is low [ ] . in vietnam, shs members, including assistant doctors or nurses, are assigned to individual schools and usually attend a -day training session annually, but this does not occur regularly (tien le thi huong, personal communication, july ). the role of shs members in vietnam is specified as "health records management of students and teachers, health education, first aid, care of general illness, and management of health equipment" [ ] . however, systematic school health education and activities would likely be inadequate for students unless the practical competencies of shs members are developed through continuing training. thus, it is necessary to identify shs members' training needs prior to the development of training programs to improve their capacity. accordingly, the purpose of this study was to identify shs members' training needs in a province of vietnam through a global collaboration project. this study used a cross-sectional, descriptive design. it was conducted in quang tri province, one of provinces in vietnam with a population of approximately , and an area of km . quang tri province is located in central north vietnam and consists of two urban towns and eight rural districts. as the corresponding author's university had previously collaborated with a college in quang tri province for several years, this study was conducted in the province to develop a future training program for shs members. an shs member qualified as an assistant doctor or nurse is assigned to each school. in some schools, non-health professionals are responsible for practical work as shs members. the study targeted an entire sample of shs members of all schools, including non-health professionals, responsible for school health in primary and secondary schools in quang tri province in vietnam. out of shs members, who had valid email addresses provided by department of education training (doet) in quang tri province were targeted in this study. the response rate was . % (n = ). twenty shs members were excluded because of missing data, outliers, or duplicate submissions. ultimately, the data of shs members were included in the analysis. the training needs assessment questionnaire (tnaq) developed for the current study consists of three parts: perceived importance of competency for shs members ( items), perceived performance of competency for shs members ( items), and sociodemographic information ( items). the competency items for shs members were developed in multiple steps ( figure ): organizing initial items pertaining to shs members' competencies according to a literature review, back translation, expert review using a content validity index, pretest, and finalization. the items were scored using a five-point likert scale ranging from (not important/confident) to (very important/confident). the cronbach's alpha value assessing internal consistency reliability was . in this study. initial items pertaining to shs members' competencies in vietnam were developed using eight domains from the health teachers' job analysis [ ] , which is consistent with roles of shs member proposed by school health law in korea and vietnam. one domain of "establishing healthy and safe physical environment" based on the monitoring and evaluation guidance for school health programs [ ] . the initial questionnaire consisted of items pertaining to shs members' training int. j. environ. res. public health , , of needs in nine domains: providing emergency care (domain ), providing health education (domain ), operating the school health room (domain ), implementing health screening for students (domain ), controlling infectious diseases (domain ), establishing a healthy and safe physical environment (domain ), providing health counseling (domain ), implementing health promotion programs (domain ), and developing professionalism (domain ). initial items pertaining to shs members' competencies in vietnam were developed using eight domains from the health teachers' job analysis [ ] , which is consistent with roles of shs member proposed by school health law in korea and vietnam. one domain of "establishing healthy and safe physical environment" based on the monitoring and evaluation guidance for school health programs [ ] . the initial questionnaire consisted of items pertaining to shs members' training needs in nine domains: providing emergency care (domain ), providing health education (domain ), operating the school health room (domain ), implementing health screening for students (domain ), controlling infectious diseases (domain ), establishing a healthy and safe physical environment (domain ), providing health counseling (domain ), implementing health promotion programs (domain ), and developing professionalism (domain ). back translation was used to develop culturally appropriate measurements [ ] . a bilingual translator, who was fluent in english and vietnamese and understood school health in vietnam, translated the english version into vietnamese. another english-vietnamese translator, who had not seen the original version, translated the vietnamese version back into english. research team members compared both versions in the original language for inconsistencies, mistranslations, and meaning. in the final step, a committee meeting was held between the research team members and another english-vietnamese translator who was not involved in the previous steps. content validity was assessed by three school health experts in korea and three school health experts in vietnam, consistent with the criteria outlined by lynn [ ] . items with a content validity index of less than . were reviewed by three authors (sk, hl, and hyl) to determine whether the item was necessary for the purpose of the study. two items were deleted ("teaching cardiopulmonary resuscitation and first aid" and "providing group education," as they overlapped with other items), and two items were added ("providing counseling to students with mental or psychological trauma," as proposed by the doet in quang tri province, and "planning health promotion programs," as suggested by a korean expert). one item was modified from "providing counseling to students with abnormal health problems" to "providing counseling to students with health problems." this resulted in a total of items for a pretest. back translation was used to develop culturally appropriate measurements [ ] . a bilingual translator, who was fluent in english and vietnamese and understood school health in vietnam, translated the english version into vietnamese. another english-vietnamese translator, who had not seen the original version, translated the vietnamese version back into english. research team members compared both versions in the original language for inconsistencies, mistranslations, and meaning. in the final step, a committee meeting was held between the research team members and another english-vietnamese translator who was not involved in the previous steps. content validity was assessed by three school health experts in korea and three school health experts in vietnam, consistent with the criteria outlined by lynn [ ] . items with a content validity index of less than . were reviewed by three authors (sk, hl, and hyl) to determine whether the item was necessary for the purpose of the study. two items were deleted ("teaching cardiopulmonary resuscitation and first aid" and "providing group education," as they overlapped with other items), and two items were added ("providing counseling to students with mental or psychological trauma," as proposed by the doet in quang tri province, and "planning health promotion programs," as suggested by a korean expert). one item was modified from "providing counseling to students with abnormal health problems" to "providing counseling to students with health problems." this resulted in a total of items for a pretest. a pretest was conducted with five shs members who were working in schools in the research area, via an online survey [ ] . no items were considered difficult to understand in a vietnamese context. ultimately, items probing shs members' competencies were included in the final tnaq. in cooperation with quang tri medical college and the doet, an online survey was conducted. survey announcements were sent to all shs members via email. after reading an explanation of the study that was provided when accessing the online survey, shs members who wished to participate clicked a button to provide consent. twenty days later, the doet sent a reminder email to consenting shs members. data were collected from july to , . data were analyzed using ibm spss statistics for windows, version . (ibm corp., armonk, ny, usa). participants' characteristics were analyzed using means, standard deviation (sds), frequencies and percentages. a t-test was performed to compare shs member' performance levels according to general characteristics. perceived performance and perceived importance ratings provided by shs member were analyzed using means, sds, and paired t-tests. shs member' training needs were identified using the borich needs assessment [ ] and the locus for focus model [ ] . borich needs assessment identified the "what is" (performance level) and "what should be" (importance level), and weighted the "what should be" (importance level) of each item to determine the priority of items [ ] . the priority of training needs was represented by an x-y plane using the locus for focus model [ ] . the median value of the x axis shows the average score of the importance level, while that of the y axis shows the average score of discrepancy between the importance and performance level (i.e., first quadrant is higher than the average importance level and higher than the average discrepancy between the two levels). the number of items having priority in the borich needs assessment can be decided using the number of items included in the first quadrant (in the right upper quadrant) of the locus for focus model. top ranking consistent items of the borich needs assessment and items in the first quadrant from the locus for focus model represented the highest priority of training needs for shs members [ ] . the study was approved by the institutional review board at the institution with which the first author was affiliated (irb no. y- - ). before the online survey began, the study purpose, anonymity, and confidentiality were explained. participants were advised that clicking the "next" button indicated consent to participate. participants' mean age was . years (sd = . ). approximately . % of participants were assistant doctors or nurses, and . % reported other professions (e.g., accountant and librarian); . % and . % were primary and secondary school staff members, respectively. about . % of the participants worked in schools in urban towns in quang tri province, and . % of schools contained minority students. regarding characteristics related to school health, . % of health education providers were shs members and . % of schools provided regular heath education. of the participants, . % did not receive training regarding school health within the past two years (table ) . perceived performance levels of nurses or physicians' assistants (mean = . ) were significantly higher than those of non-health professionals (mean = . ; t = . , p < . ). perceived performance levels of participants working in secondary schools (mean = . ) were significantly higher than those of participants working in primary schools (mean = . ; t = − . , p = . ). participants who received training in school health within the past two years (mean = . ) reported significantly higher performance than those who had not received such training (mean = . ; t = . , p = . ). there was no significant difference in shs members' performance according to district (t = . , p = . ) or whether schools contain minority students (t = − . , p = . ; table ). participants' mean performance score over all items was . (sd = . ), whereas the overall average importance score was . (sd = . ). the average scores significantly differed between performance and importance (t = . , p < . ) and all items exhibited statistically significant differences between ratings of performance and importance ( table ) . the average score for shs members' training needs was . according to the borich needs assessment. borich needs scores for all items in domain (controlling infectious disease) were higher than the average borich needs score. borich needs scores for ≥ % of items were higher than the average score for domains (providing emergency care), (implementing health screening for students), and (developing professionalism; table ). there was considerable discrepancy in importance and performance in the locus for focus model ( figure ). the first quadrant represented the highest priority, as the importance and discrepancy between importance and performance were higher than average. in total, priority training needs were included in the first quadrant and eight of nine domains (all but domain , implementing health promotion programs). domain (controlling infectious diseases), domain (providing emergency care), and domain (implementing health screening for students) included numerous items pertaining to priority training needs (table ) . fourteen items were both in the top priority items in the borich needs assessment and in the first quadrant of the locus for focus model. ten items, which were derived from only one of the borich needs assessment or the locus for focus model, were not given high priority in training needs (table ) . were included in the first quadrant and eight of nine domains (all but domain , implementing health promotion programs). domain (controlling infectious diseases), domain (providing emergency care), and domain (implementing health screening for students) included numerous items pertaining to priority training needs (table ) . fourteen items were both in the top priority items in the borich needs assessment and in the first quadrant of the locus for focus model. nine items, which were derived from only one of the borich needs assessment or the locus for focus model, were not given high priority in training needs (table ). priority of training needs in the locus for focus model. figure . priority of training needs in the locus for focus model. an online consensus development panel was assembled to obtain agreement regarding training needs and share the survey results. in total, shs members who attended the annual shs members' training responded. all of the top training needs for shs members were agreed upon through consensus, with percentages ranging from . % to . %. this was a nurse-led global health project that aimed to identify the priority of training needs to strengthen the capacity of shs members, who rarely have opportunities to continue professional development. it is worth mentioning that the cooperation of researchers from both countries was beneficial in conducting this needs assessment prior to designing a vietnam-specific training program, as integrating the needs and circumstances of shs members in vietnam and would benefit from evidence accumulated pertaining to korean school health teachers. as part of a global commitment to achieve sdg , the findings provide data to help establish training programs for shs members, who play key roles in providing quality school health service and improving health knowledge and healthy behaviors of students in lmics. the tnaq will be useful in future research in lmics to provide valid and reliable assessments of the performance and importance of shs members' activities. the domain of "controlling infectious diseases" was identified as a top priority area for shs members' training, as lower performance than average was reported while the domain was considered of higher than average importance for all competency items but one. specifically, "building a system of infectious disease control" and "monitoring and managing students with infectious diseases" represented the highest priority training needs. as suggested by kim and colleagues [ ] , it is important to establish systems and action plans in schools that address outbreaks of pandemic diseases. in korea, school health teachers plan and take action in response to infectious diseases in schools appropriately according to the situation, by following an infectious disease manual [ ] distributed by the ministry of education. for example, in general cases of infectious disease, school health teachers confirm vaccination completion of students and encourage vaccination for unvaccinated students; provide preventive education regarding infectious disease for students, parents, and school personnel; and monitor students at-risk of infectious disease and report infected students to public health centers [ ] . during infectious disease outbreaks such as the middle east respiratory syndrome (mers), school health teachers are required to coordinate school health services, develop plans for distributing infection-control supplies, construct referral systems to public health centers and local clinics for screening, and provide health education for both parents and students for preventing infectious disease [ ] . in resource-limited communities in lmics, shs members are expected to play a vital role in responding to both infectious diseases in general and outbreaks, which highlights the need for training programs. providing emergency care (domain ) included the three top-ranking items requiring priority training. according to recommendations on the role of school nurses during emergencies by the national association of school nurses (nasn) [ ] , training content for school nurses should include identifying hazards, serving on planning groups, building emergency response plans, and coordinating first aid response teams; these were identified in the current study as items that should be prioritized in shs members' training. where resources and accessibility of medical facilities are limited in lmics, it would be necessary to strengthen the capacity of shs members to appropriately manage medical emergencies in schools. nasn emphasized shs members as key persons to act as liaisons between community resources [ ] . thus, shs members should be trained to organize community networks and link community transportation resources for urgent patient transfers. in a previous study [ ] , school nurses who were well-trained in medical emergency response plans were confident when managing head/neck injury of students and determining the availability of emergency equipment. note that more than half of the shs members in the current study were non-professionals who reported low competency in several skills. therefore, considerable education regarding how to address emergencies should be provided to shs members. in addition to infectious and emergency care, the shs participants in this study exhibited high training needs in the areas of health screening, counseling students with mental or psychological trauma, and protecting children from danger from road traffic, animals, and fire. according to the american academy of pediatrics on school health [ ] , schools should provide regular and developmental health screening for vision, oral health, hearing, height, and weight for secondary prevention in schools. it is interesting to consider counseling students with mental or psychological trauma and protecting children from danger from road traffic, animals, and fire. in a recent study of vietnamese adults, . % had been exposed to a traumatic event in their life [ ] . children of parents who have experienced traumatic events are likely to experience psychological problems, as evidenced by findings that children of war veterans with post-traumatic stress disorder (ptsd) experience more psychological issues than do children of veteran fathers without ptsd [ ] . in addition, motorcycles are a major form of transportation in vietnam, and mortality of children and adolescents due to motorcycle accidents is high [ ] . further, road traffic injuries are common among older adolescents and those who consume alcohol before riding motorcycles [ ] . this suggests that training for shs members should include strategies to educate adolescents regarding the risks associated with motorcycling. no items were identified as being of high priority in "implementing health promotion programs" (domain ) in the current study. the results are consistent with low levels of awareness of the importance of health promotion [ ] and promoting healthy behaviors among adolescents [ ] in lmics. however, the who has emphasized that schools are of strategic value for guiding preventive health behaviors as a key to health promotion [ ] . the who has further stated that children and adolescents are the most important population for fostering the adoption of healthy lifestyles in the future [ ] . in addition, as school-based health promotion programs exert positive effects on children's and adolescents' health [ , ] , consideration should also be given to efforts to increase awareness about these issues among shs members in the process of developing the training program. providing continuous training for health professionals in areas with shortages of, and low accessibility to, medical resources is crucial [ ] and would ultimately exert a significant effect on children's and adolescents' health [ ] . the current study showed that non-health professionals (e.g., accountants and librarians) in charge of school health demonstrated significantly poorer performance than did health professionals, indicating an urgent need to develop the capacity of the former to provide school health. it is noteworthy that increased training and opportunities for continuous professional development could reduce variation in competency among types of shs professional [ ] . the study was subject to some limitations. it is difficult to generalize the results regarding training needs to all shs members in lmics because the study was conducted in a single province of vietnam. in addition, training needs were examined only via an online survey. further research involving qualitative needs assessment is required to explore the training context in-depth. the current findings support the need for a policy of mandatory training for school health professionals, including nurses. training needs for health promotion were of low priority, but there is a need for political support for long-term health promotion programs for young people and efforts to increase awareness regarding the importance of this issue. this study was conducted to identify training needs of all shs members of a province in vietnam, one of the lmics, in close cooperation with a local college and provincial education department. therefore, this study's strength is that the results can be practically applied to training programs for shs members in the future. it is important to assess shs members' performance in each country at a local level and provide them with needs-based appropriate training. the current findings could be of utility for other developing countries in research and policy pertaining to shs members. this study consisted of a korean-vietnamese collaborative project to identify high-priority training needs of shs members in a province in vietnam. the findings provide empirical evidence that could inform the development of a vietnam-specific training program for shs members. shs members' competencies in lmics with limited resources could exert a significant effect on young people's health. training content should be organized to control infectious diseases and enhance the ability of shs members to manage emergency care in school settings. in addition, long-term health promotion should receive focus. variations in schools' commitment to health and implementation of health improvement activities: a cross-sectional study of secondary 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constant effort in this study. the authors declare no conflict of interests. key: cord- -n zxbuf authors: o’kane, gabrielle title: telehealth—improving access for rural, regional and remote communities date: - - journal: aust j rural health doi: . /ajr. sha: doc_id: cord_uid: n zxbuf nan over the past few years, the alliance has been advocating for improvements to digital health capability and greater access to telehealth services for rural, regional and remote communities. the alliance has been supportive of my health record, e-prescribing, secure messaging and home monitoring, for their potential to enhance health care integration and bolster coordinated care for improved health outcomes of rural, regional and remote communities. however, it has been the fractured implementation of these initiatives that have caused some angst amongst health professionals and consumers alike. for example, effective implementation requires a whole-of-government approach that has the australian digital health agency working collaboratively with the department of infrastructure, transport, regional development and communications. this would ensure that the necessary infrastructure is in place to facilitate full functionality of digital health initiatives. yet we know that not all parts of the country have the telecommunications infrastructure with sufficient bandwidth and connectivity. it is imperative that all australians, regardless of location and treatment environment, are able to benefit from the availability of personal health information at the point of care. if not addressed, the system has the potential to increase health inequities that people in rural and remote australia already experience. further, the australian government has rightly prioritised training for gps and pharmacists to enable them to understand the benefits, features and functionalities of my health record. the government has also provided ehealth practice incentive payments to gps to allow them to keep abreast of changes to digital health and improve their data management and secure messaging systems. however, to achieve a truly integrated digital health system that improves care coordination, allied health professionals, nurse practitioners and aboriginal health practitioners also need to be linked to the system and offered similar incentives. much work still needs to be done to enable the entire health care system to use secure messaging that guarantees both patient privacy and more efficient data exchanges. while the broader digital health transformation of health care may be moving relatively slowly, covid- has been the catalyst to rapidly change the australian government's policy position on telehealth services. this has been very welcome amongst rural health providers and consumers. the rolling out of the temporary medical benefits schedule (mbs) telehealth items since march to gps, medical practitioners, nurse practitioners, midwives and allied health providers has been vital to help reduce the risk of community transmission of covid- and provide protection for patients and health professionals alike. now is the time to capitalise on the government's common-sense approach to averting a health care crisis and embrace the use of digital technologies and telehealth options for a whole range of purposes, settings and demographics. the uptake of telehealth services in general practice between april and june , during the height of the pandemic, was at . % and even higher for mental health services offered by allied health providers and specialists, at . % and . %, respectively. for allied health and specialist providers of care other than mental health, the use of telehealth was lower at . % and . %, respectively. notably, allied health and specialist providers of health services made greater use of videoconferencing telehealth than gps, who only used this modality for . % of services. there appears to be enthusiasm for the continuation of telehealth mbs items amongst the health care sector and consumers. a recent survey conducted by the royal australasian college of physicians during the covid- pandemic reported that % of respondents supported retaining the new telehealth items beyond the current crisis. the survey also found that almost % of the sample of members stated that their patients were more likely to keep their telehealth appointments than their face-to-face appointments, which suggests that the convenience of not having to travel to appointments is highly attractive to consumers, regardless of place of residence. previous research published in this journal has already demonstrated that using telehealth-based models of care can have benefits for those residing in rural and remote communities, the health care provider and the system. , one study showed that telehealth can be successfully applied to the management of patients with a spinal fracture, which allowed the patient to be cared for in their local rural hospital and offered opportunities for allied health professionals to upskill and work to their full scope of practice, while also providing cost efficiencies for the health service. another innovative application of telehealth was an integrated approach to oral health in rural aged care facilities with an oral health therapist screening residents using an intraoral camera probe that transmitted a live feed to a dentist in another health care facility. with so few dentists living in rural and remote australia, there is real opportunity to scale up this sort of application of telehealth for other population groups such as aboriginal and torres strait islander people living in remote communities. in rural and remote education settings, speech pathology teletherapy services have been able to overcome limited connectivity issues by successfully using low-bandwidth videoconferencing facilities. these examples demonstrate that telehealth can offer rural and remote communities a more flexible and convenient mode of access to health care, while also upskilling rural health generalists, parents and educators by linking them and their patients or clients to urban-based specialists. an issue that still needs to be addressed more fully is the quality of telehealth services, particularly when considering the use of telephone versus videoconferencing consultations. certainly from the perspective of specialist physicians, videoconferencing is considered preferable for patient assessment and establishing patient rapport. it is better for communicating with geriatric patients and those with impaired hearing and those from a non-english-speaking background. however, the same survey found that many elderly patients found it difficult dealing with the technology required to use videoconferencing platforms and poor connectivity was also flagged as a problem for those living rurally. one of the recommendations from the report was that government should consider additional funding for videoconferencing and other digital health technology for selected households. the alliance would certainly support such measures, but there must also be resources put towards improving digital health literacy for both consumers and health care providers so that all australians can be enabled to make optimal use of digital and telehealth services. one final consideration in the move to greater access to telehealth services must be about ensuring that rural health private providers are offered protection from telehealth providers that offer no local services. the australian government's recent decision to reform the medicare-subsidised telehealth services is helpful. under stage of the telehealth reforms, the gp telehealth provider will be required to have an ongoing relationship with the patient receiving the care to enable continuous, high quality care. specifically, the patient will have to have seen the same gp or practice in the last months to be eligible to receive the medicare rebate. ultimately, without some safeguards, primary care practices, particularly those in rural and remote communities, may not remain viable, which short-changes rural communities in the long term. inquiry into the my health record system: senate committee on community affairs telehealth during covid- royal australiasian college of physicians. results of racp members' survey of new mbs telehealth attendance items introduced for covid- integrated approach to oral health in aged care facilities using oral health practitioners and teledentistry in rural queensland telehealth-based model of care redesign to facilitate local fitting and management of patients with a spinal fracture requiring a thoracic lumbar sacral orthosis in rural hospitals in new south wales speech-language pathology teletherapy in rural and remote educational settings: decreasing service inequities continuous care with telehealth stage seven australian government key: cord- -eu gvjlx authors: koh, howard k.; cadigan, rebecca o. title: disaster preparedness and social capital date: journal: social capital and health doi: . / - - - - _ sha: doc_id: cord_uid: eu gvjlx the first decade of the st century has pushed the field of disaster preparedness to the forefront of public health. in a few short years, the world has witnessed the far–ranging ramifications of / and anthrax ( ), sars ( ), the indian ocean tsunami ( ), hurricane katrina ( ) and the looming threat of pandemic influenza. societies everywhere are responding to these developments with new policies that commit added resources for protection against future disasters. to date, literature relevant to social capital has focused largely on the value of existing social capital in disaster mitigation and recovery. for example, among environmental scientists, there is growing interest in the role of social capital and global climate change (adger, ; pelling & high, ) . in light of the causal link between global climate change and the increasing incidence of natural disasters such as hurricanes, tsunamis and floods, researchers have identified social capital as an important tool in disaster mitigation. for example, semenza, et al. ( ) found that during the heat wave in chicago, in addition to location (i.e., living on the top floor of building) and access to air conditioning, variables related to social contact and networks were also strong predictors of mortality. specifically, the authors found that individuals who participated in church or social groups had a significantly lower risk of death during the heat wave. it is clear from these findings that social networks and social capital are important tools in community coping with stresses, and serve to mitigate adverse outcomes of disasters and other events associated with climate change. similarly, existing social capital has served as a vital instrument in the recovery and rebuilding efforts following numerous natural disasters. nakagawa and shaw ( ) hypothesized that differing rates of post-disaster recovery following major earthquakes in kobe, japan and gujarat, india could be attributed to disparate levels of existing social capital in the two cities. in the immediate aftermath of the kobe earthquake, neighborhood groups (previously formed in the s to protest polluting factories) quickly reconvened to assist with school evacuation, establish community kitchens, and help protect against looting. these actions accelerated response efforts and served to initiate rebuilding. following hurricane katrina in , a number of observers (garreau, ; turner & zedlewski, ) attributed many of the barriers to rebuilding new orleans to the previously documented low social capital there (putnam, ) . nevertheless, exceptions were notable. for example, within a matter of weeks, select tight-knit groups such as the vietnamese enclave in east new orleans were already engaged in rebuilding efforts (hauser, ; shaftel, ) . many of the , vietnamese in new orleans had previously emigrated to the u.s. in the - s and have since maintained strong social and cultural networks. using a church as headquarters, the vietnamese residents of east new orleans formed neighborhood teams to rebuild, repair, and decontaminate houses, prepare meals for families visiting to check on their property, and drive one another to work, church, and temporary housing. for the preparedness and response phases of preparedness, much of the current efforts are focusing on the process of creating new social capital. one poignant illustration is the dramatic volunteer convergence on new york city following the terrorist attacks on september th, , documented to include over , individuals within two and a half weeks. a qualitative study conducted by lowe and fothergill ( ) found that the primary motivation for volunteering was a need "to contribute something positive and find something meaningful in the midst of a disaster characterized by cruelty and terror" (p. ). the authors characterized the impact of such spontaneous volunteerism on both the community and the volunteers themselves, i.e., affecting both groups and individuals. one volunteer described the work as "honoring our commitment to the american public" (p. ), implying a broad national community. individual impact was noted when "the volunteers found that by working with new groups of people. . . . . they experienced a sense of solidarity with different community members" (p. ). in another example outside of the united states, an estimated million volunteers responded to assist with search and rescue, medical aid, transportation, and provision of shelter following the earthquake in mexico city (dynes & quarantelli, ) . a major benefit of preparedness planning would be to strengthen local public health infrastructure which has been traditionally fragmented and severely underfunded. over a few short years, nascent efforts on preparedness have broadened the initial focus on training federal and state government leaders to include local officials and indeed all members of society. lessons from sars and hurricane katrina have underscored the message that every person has an opportunity and responsibility to protect themselves, their families and their communities. as a result, in the world of public health, emergency preparedness training now extends deeply to the local level with respect to planning, communication and training. in many parts of the united states, efforts have focused attention to regionalization of local public health, surge capacity planning, vulnerable populations, risk communication, and training through exercises and drills. all these efforts have the potential to boost local public health infrastructure and build a legacy of social capital and social networks in local communities. the remainder of this chapter will explain in greater detail how such preparedness efforts apply to dimensions of social capital at the local level, particularly with respect to pandemic influenza preparedness. the threat of pandemic influenza has sparked heightened planning worldwide. the world health organization (who) urges that each country and community develop and regularly update a pandemic preparedness plan. who guidance centers on issues such as surveillance, communications and prioritization of scarce resources. as of december , countries have completed such plans (uscher-pines, omer, barnett, burke & balicer, ) . the united states unveiled its national pandemic influenza plan in november, , addressing areas such as domestic and international surveillance, vaccine development and production, antiviral therapeutics, communications and state/local preparedness. moreover, each of the states has developed and publicized plans, as summarized on www.pandemicflu.gov. all nations understand the importance of priority setting in preparedness planning, although such plans currently vary by rationale of prioritization of antiviral agents, vaccines and other scarce resources (uscher-pines, omer, barnett, burke, & balicer, ) . as "all preparedness is local" however, such plans can only come alive through full engagement at the local level. both bonding and bridging social capital apply throughout such plans. . . . . local/regional planning the current fragmented status of local public health in the united states has left few cities or towns (aside from the major metropolitan areas) capable of responding on their own. for the most part, local health departments lack the personnel, resources or capacity to respond to mass casualties without the support of surrounding communities. to address this challenge, many states have turned to regionalization of resources and services to build emergency preparedness capacity at the local level. a study of state public health preparedness programs conducted in fall, by the association of state and territorial health officials (astho) found that most states tended to subdivide their organizations into regions for preparedness purposes, with more than half of such regions created post- / (beitsch et al., ) . massachusetts, nebraska, illinois, kansas and the northern capital region (greater metropolitan washington dc) are among the states that have done so. for example, massachusetts, a state of . m, traditionally had a highly decentralized local public health system with autonomous cities and towns. nevertheless, after / the state reorganized into seven emergency preparedness regions and subregions (koh, elqura, judge, & stoto, ) . in another example, the primarily rural state of nebraska of . m people has developed regions in efforts to improve capacity. preliminary qualitative information suggests that regionalization has built social capital for groups and individuals. the national association of county and city health officials (naccho) notes that regionalization has promoted coordination (of local public health and partners in public safety and emergency medical services), standardization (of resources and emergency plans) and centralization of local emergency response capability (bashir, lafronza, fraser, brown, & cope, ; hajat, brown, & fraser, ) . in so doing, improved collective efficacy can be realized. analyses have noted that regionalization has served as a foundation for sharing resources, coordinating planning, conducting trainings and improving capacity. for example, in massachusetts, regionalization led to emergency local capacity essential for pandemics and mass casualties, such as establishment of / emergency on-call capacity for all local public health officials in the state (when none previously existed) and mutual aid agreements for over % of local public health departments (compared to none previously). in fact, in the few short years of its existence, regionalization has facilitated the efficient organization of hepatitis a immunization clinics in the face of food borne outbreaks, and coordination of seasonal flu vaccine distribution during the shortages of the - season (koh, shei, judge et al., ) . such examples reflect enhanced social capital within groups (e.g., nurses and allied health professionals) and bridging between groups (local health groups and state public health officials). most notably, regionalization has fostered communication and connections between multiple groups: public health and public safety, interested parties in neighboring towns, local and state leaders, and volunteers across the state. multiple parties that rarely worked together prior to / are now meeting regularly to plan joint responses and clarify roles and responsibilities. planning for pandemics and mass casualties requires ramping up the current national health care system to care for thousands of extra ill patients. building surge capacity in this way can generate bonding and bridging capital, mobilizing and unifying a vast array of societal resources. based on past pandemics, the u.s. department of health and human services (dhhs) has modeled its pandemic planning on scenarios ranging from moderate (such as the and pandemics) to severe (such as the pandemic). current models project as many as m cases nationally, % of cases requiring outpatient medical care, and up to . m requiring hospitalization (hamburg et al., ) . the u.s. centers for disease control and prevention (cdc) has developed the software program flusurge, which provides hospital administrators and public health officials local estimates of the surge in demand for hospital-based services during the next influenza pandemic. the challenge of surge capacity remains enormous, as national trends over the past several decades reflect declining, not increasing, capacity. with this daunting backdrop, the united states is working toward increasing surge capacity, explicitly defined by the u.s. agency for healthcare research and quality ( a) as "a health care system's ability to expand quickly beyond normal services to meet an increased demand for medical care in the event of bioterrorism or other large-scale public health emergencies" (p. ). the u.s. health resources and services administration (hrsa) has offered surge capacity benchmarks with respect to staff, space and supplies, as shown in table . (agency for healthcare research and quality, b) . building staff can be viewed as an exercise in creating bonding capital, i.e., within the community of health care providers. additional personnel needed for deployment in a crisis would include, in addition to physicians (approximately , in the u.s.) and nurses (approximately . m in the u.s.), veterinarians, pharmacists, mental health professionals and a host of other allied health professionals. such providers would not only administer direct care to those who are sick but could also aid with mass prophylaxis efforts to the many more who may be exposed or at risk. to augment this national network, communities across the u.s. are engaging volunteers in emergency response. with respect to space, all hospitals have been charged by hrsa and other organizations to identify additional beds for use in pandemics and emergencies. in addition to staffed beds (beds that are licensed, staffed, and physically available), all acute care hospitals are ascertaining surge capacity by identifying other beds that: are licensed but not staffed, can be made available within hours (by discharging patients and canceling elective procedures) or within hours (through use of non-traditional locations such as hospital cafeterias, chapels, etc.). in the event that hospital capacity is still overwhelmed, professionals across the country are currently identifying other health care facilities such as community health centers (koh, shei, bataringaya et al., ) or even non-medical sites such schools, gymnasiums, armories, and convention centers. considerations for such facilities include dimensions such as bed capacity, sanitary facilities, food services, and security. the shortage of medical supplies has also prompted bridging outside the medical world to other parts of government and society to generate sufficient resources. many have argued that preparing for pandemic influenza first entails mastering the proper coordination of national vaccination efforts for annual seasonal influenza, which yearly leads to , deaths and , hospitalizations (thompson, shay, & weintraub, . in particular, the fragmented nature of the national seasonal influenza vaccine supply became starkly apparent during - , when a national low of m doses led to prioritization of risk groups for immunization for the first time. production for - is now estimated to reach a high of - m doses, however (fauci, ) . shortages of antibiotics and antiviral agents may require interaction with the federal strategic national stockpile (sns), managed by the cdc and dhhs. the sns contains prepackaged pharmaceutical agents that can be deployed to states at the governor's request. all states have prepared preliminary plans for the receipt and management of stockpile materials, and many have initiated planning for emergency dispensing at the local level. acquiring such resources and even determining the resources needed are a tremendous source of activity and controversy. one area involves personal protective equipment (ppe) where, for example, experts differ about recommendations regarding proper use of surgical masks, n respirators and other equipment (institute of medicine board on health sciences policy, ). additionally, ventilators represent a critical limiting physical resource. there are approximately , ventilators in the u.s., with as many as , in use at any given time for medical care; and more that , required during a typical influenza season (osterholm, ) . in the event of a pandemic, the number of patients requiring mechanical ventilation would likely exceed this capacity in excess of % (hamburg et al., ) . all disasters expose disparities. as mentioned previously, hurricane katrina has been a recent disaster that has graphically highlighted vulnerabilities of special populations, the varying levels of social capital within those populations, and the need to ensure equity in preparedness. a survey revealed that % of those who did not evacuate before hurricane katrina were either physically unable to do so or had to care for someone who was physically unable to leave. % of evacuees reported having no health insurance coverage at the time of the hurricane (brodie, weltzien, altman, blendon, & benson, ) . national groups have redoubled efforts to address the needs of special populations, defined by the cdc ( ) as "groups whose needs are not fully addressed by traditional service providers or who feel they cannot comfortably or safely access and use the standard resources offered in disaster preparedness, relief, and recovery" (p. ). they include, but are not limited to: ) those who are physically or mentally disabled (blind, deaf, hard-of-hearing, cognitive disorders, mobility limitations); ) limited or non-english speaking; ) geographically or culturally isolated; ) medically or chemically dependent; ) homeless; ) frail/elderly and children. such groups would need to bridge to resources currently not available to them. issues of trust in, and trustworthiness of, authorities charged to protect them further complicate this issue. planning for special populations has increased recently. such planning may differ dramatically for densely populated urban settings as opposed to more sparsely populated rural settings; each community with its own profile of risks and assets. examples of special populations planning include evacuation planning for elderly immobile populations in nursing homes, targeted risk communication strategies for non-english speaking populations, and coordination of services for people who are homeless, homebound, or medically or chemically dependent. such populations are particularly vulnerable to broader social forces affecting their communities. overcoming social isolation in these instances remains a daunting societal challenge. in a time of crisis, all members of society expect and deserve accurate information that is conveyed simply, clearly, and in a timely fashion. such information is critical not only for all to understand roles and responsibilities in times of crisis but also for how and when to access resources. in this regard, the who, cdc and other organizations have afforded considerable attention and resources to upgrading media plans, training of communicators, and message preparation and delivery. to a great extent, the responsibility for such risk communication will fall on government public health authorities through broad use of the media. this presents special challenges in the u.s., where recent surveys show that less than % of the general public trust government public health authorities "a lot" as a source of useful and accurate information about an outbreak, compared to significantly higher levels in other parts of the world, such as taiwan, hong kong and singapore . in particular, it is unclear exactly how much the public understands the concept of "pandemic influenza" and how it differs from the term "avian influenza". also, there are many other subtleties in communicating relevant information to the public and the press. for example, the uncertain efficacy of antiviral agents for pandemic influenza may not be well known. in chapter of this book, viswanath explores the information disparities affecting populations in society. building public awareness now through regular communication can enhance trust and confidence in advance of any future pandemic. in preparing for a disaster, professionals and the public need continuous education and training. groups such as the federally funded academic centers for public health preparedness have been charged with exploring many such educational avenues, including face-to-face teaching, train-the-trainer initiatives (orfaly et al., ) , distance learning initiatives (moore, perlow, judge, & koh, ) and other modalities. recently, the public health community has moved aggressively into exercises and drills as a favored educational modality (cadigan, biddinger, & koh, ) . mounting a rapid, coordinated, integrated local response to mass casualty events such as pandemic influenza necessitates tight collaboration among a host of participants, including emergency management, public health, law enforcement, fire, emergency medical services, health care providers, public works, municipal government, and community-based organizations. exercises, defined as any event beyond the planning process that gathers people to test or improve preparedness (u.s. department of homeland security, ) , both teach and test such coordination for individuals and organizations. involving representatives from multiple agencies to exercise together in a regular fashion facilitates an iterative cycle of developing plans, training personnel, testing preparedness, and improving plans even further to clarify specific roles and responsibilities. both bonding and bridging capital can be enhanced in this way. for example, tabletop exercises are often organized around multiple tables, with each table representing one local municipality. key government officials from across various agencies work together at each table, while being forced to interact with other towns/tables as well as state agencies. resources can be enhanced by building bonding capital within each professional group, each agency, each town, as well as bridging capital across agencies, communities and between local and state officials. furthermore, since public health disasters are critical but rare, exercises serve the vital function of testing plans in a concrete and memorable fashion. use of local tailored scenarios provides exercise participants with a sense of urgency as well as concrete opportunities to understand the complex coordination involved in local emergency response. furthermore, respondents can test their understanding of the national incident management system and the incident command system. such active, experiential learning appears to have greater educational impact than more conventional, didactic lectures, particularly for rare events (streichert et al., ) . these exercises build social networks of responders. qualitative studies suggest that exercises improve communications with colleagues from other agencies, force participants to address inadequacies in communications systems and protocols, and promote strategies to ensure presentation of consistent messages. by convening with local/regional partners, participants realize potential opportunities to increase capacity by sharing resources with neighboring communities. bringing together participants from a range of disciplines enhances opportunity to learn about the unique services, skills, and expertise offered by others. an ongoing area of research is to quantify these outcomes in a standardized way that demonstrates enhanced preparedness. while we offer our ideas here on the ramifications of social capital on evolving public health preparedness work, much of this information is qualitative and/or preliminary. many observations noted here need verification and validation. furthermore, the intense current focus on community disaster preparedness is still relatively new. academic investigation should verify and extend these concepts, offer more quantitative assessments of social capital as applied to disasters, demonstrate their utility through more rigorous analyses, and ascertain whether initial societal changes found in qualitative studies will be enduring and sustained. moreover, we have presented concepts of social capital as being overwhelmingly positive in their nature when in fact research in other areas has documented possible negative ramifications noted elsewhere in this book. nevertheless, much of the current work regarding public health preparedness can enhance social capital through stabilization and growth of the current fragile public health infrastructure, i.e., workforce capacity and competency, information and data systems, and organizational capacity (cdc, ) . disaster planning has undoubtedly revived and accelerated community discussions about societal planning, obligations, and expectations in a time of crisis. regionalization of local health has generated new local capacity. attention to special populations has renewed emphasis on commitments to equity and raises key questions about obligations of community members to one another. efforts to enroll volunteers through mrc and other initiatives have revitalized discussions on expectations of service in a community. attention to surge capacity, resource shortages and the prospect of alternate sites of care during a mass casualty event has raised explicit discussions about obligations and expectations. agencies have advanced bridging in the common mission of protecting the public. inherent in all planning has been the importance of trust building, particularly in information sharing and risk communication. moreover, such investments may well be helping to build a more cohesive, integrated, prepared national and global community where all understand their interdependence in the midst of a crisis. in a time of social isolation where many are "bowling alone", disaster preparedness efforts may serve as a force that reverses this trend and contributes to a legacy of stronger local public health and a more revitalized society for the future. tyndall centre for climate change research -working paper no surge capacity-education and training for a qualified workforce optimizing surge capacity-regional efforts in bioterrorism readiness local and state collaboration for effective preparedness planning a state-based analysis of public health preparedness programs in the united states attitudes toward the use of quarantine in a public health emergency in four countries experiences of hurricane katrina evacuees in houston shelters: implications for future planning using regional multi-agency exercises to enhance public health preparedness social capital: dealing with community emergencies individual and organizational response to the earthquake in mexico city seasonal and pandemic influenza preparedness: science and countermeasures a sad truth: cities aren't forever. the washington post community organizing: building social capital as a development strategy a killer flu. trust for america's health institute of medicine committee on the future of emergency care in the united states health system reusability of facemasks during an influenza pandemic regionalization of local public health systems in the era of preparedness building community-based surge capacity through a public health and academic collaboration: the role of community health centers emergency preparedness as a catalyst for regionalizing local public health a need to help: emergent volunteer behavior after september th using blended learning in training the public health workforce in emergency preparedness social capital: a missing link to disaster recovery local public health agency infrastructure: a chartbook train-the-trainer as an educational model in public health preparedness preparing for the next pandemic understanding adaptation: what can social capital offer assessments of adaptive capacity? bowling alone. the collapse and revival of american community heat related deaths during the july heat wave in chicago the ninth reward: the vietnamese community in new orleans east rebuilds after katrina. the village voice using problem-based learning as a strategy for cross-discipline emergency preparedness training mrc reaches mrc unit milestone influenza-associated hospitalizations in the united states mortality associated with influenza and respiratory syncytial virus in the united states after katrina: rebuilding opportunity and equity in new orleans priority setting for pandemic influenza: an analysis of national preparedness plans public health workbook to define, locate, and reach special, vulnerable, and at-risk populations in an emergency public health's infrastructure: a status report homeland security exercise and evaluation program, volume i: overview and doctrine avian influenza frequently asked questions key: cord- - w j authors: hung, yuen w; law, michael r; cheng, lucy; abramowitz, sharon; alcayna-stevens, lys; lurton, grégoire; mayaka, serge manitu; olekhnovitch, romain; kyomba, gabriel; ruton, hinda; ramazani, sylvain yuma; grépin, karen a title: impact of a free care policy on the utilisation of health services during an ebola outbreak in the democratic republic of congo: an interrupted time-series analysis date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: w j background: during past outbreaks of ebola virus disease (evd) and other infectious diseases, health service utilisation declined among the general public, delaying health seeking behaviour and affecting population health. from may to july , the democratic republic of congo experienced an outbreak of evd in equateur province. the ministry of public health introduced a free care policy (fcp) in both affected and neighbouring health zones. we evaluated the impact of this policy on health service utilisation. methods: using monthly data from the national health management information system from january to january , we examined rates of the use of nine health services at primary health facilities: total visits; first and fourth antenatal care visits; institutional deliveries; postnatal care visits; diphtheria, pertussis and tetanus (dtp) vaccinations and visits for uncomplicated malaria, pneumonia and diarrhoea. we used controlled interrupted time series analysis with a mixed effects model to estimate changes in the rates of services use during the policy (june–september ) and afterwards. findings: overall, use of most services increased compared to control health zones, including evd affected areas. total visits and visits for pneumonia and diarrhoea initially increased more than two-fold relative to the control areas (p< . ), while institutional deliveries and first antenatal care increased between % and % (p< . ). visits for dtp, fourth antenatal care visits and postnatal care visits were not significantly affected. during the fcp period, visit rates followed a downward trend. most increases did not persist after the policy ended. interpretation: the fcp was effective at rapidly increasing the use of some health services both evd affected and not affected health zones, but this effect was not sustained post fcp. such policies may mitigate the adverse impact of infectious disease outbreaks on population health. abstract background during past outbreaks of ebola virus disease (evd) and other infectious diseases, health service utilisation declined among the general public, delaying health seeking behaviour and affecting population health. from may to july , the democratic republic of congo experienced an outbreak of evd in equateur province. the ministry of public health introduced a free care policy (fcp) in both affected and neighbouring health zones. we evaluated the impact of this policy on health service utilisation. methods using monthly data from the national health management information system from january to january , we examined rates of the use of nine health services at primary health facilities: total visits; first and fourth antenatal care visits; institutional deliveries; postnatal care visits; diphtheria, pertussis and tetanus (dtp) vaccinations and visits for uncomplicated malaria, pneumonia and diarrhoea. we used controlled interrupted time series analysis with a mixed effects model to estimate changes in the rates of services use during the policy (june-september ) and afterwards. findings overall, use of most services increased compared to control health zones, including evd affected areas. total visits and visits for pneumonia and diarrhoea initially increased more than two-fold relative to the control areas (p< . ), while institutional deliveries and first antenatal care increased between % and % (p< . ). visits for dtp, fourth antenatal care visits and postnatal care visits were not significantly affected. during the fcp period, visit rates followed a downward trend. most increases did not persist after the policy ended. interpretation the fcp was effective at rapidly increasing the use of some health services both evd affected and not affected health zones, but this effect was not sustained post fcp. such policies may mitigate the adverse impact of infectious disease outbreaks on population health. what is already known? ► evidence from previous outbreaks of ebola virus disease (evd) and other infectious diseases suggests that the use of primary health services usually declines among the general public, which can lead to important declines in population health. ► to our knowledge, there have been no evaluations of policies or strategies implemented to mitigate the impact of evd outbreaks on the use of health services in any international context. ► the introduction of user fee exemption or other free care policies (fcps) to incentivise health service utilisation have been evaluated in a number of sub-saharan african countries contexts, however, none have been evaluated in the context of an outbreak of evd or other infectious diseases. what are the new findings? ► our findings provide strong evidence that utilisation rates of many primary health services increased with the implementation of the fcp, although most increases were not sustained after the fcp ended. ► total visits and treatments for pneumonia and diarrhoea saw the largest increases while some services, such as those involving needles and blood, were not affected by the fcp. what do the new findings imply? ► the available scientific evidence suggests that fcps may be an effective strategy to mitigate the impact of evd outbreaks on the use of health services among the general public, even in resource poor settings. ► further research is needed to understand how such policies can be better implemented and additional strategies should also be explored. ► routine health information system data can be a useful tool to study the impact of fcps and other short-term policies in low income country settings. introduction widespread disruption to health systems has been observed during previous major outbreaks of infectious diseases. for example, during the - outbreak of ebola virus disease (evd) in west africa, the use of health services greatly declined in heavily affected countries. communities were fearful and lacked trust in the health system, which not only impeded response efforts, but also deterred health seeking behaviour. overall use of health services decreased by % during the peak of the outbreak. reductions were seen for maternal and child health services, as well as treatments for priority diseases such as malaria and hiv. it has been estimated that reductions in the use of health services led to mortality increases similar in magnitude to those directly attributable to evd. moreover, studies have shown that patterns of health seeking behaviour were disrupted for months after the outbreak. as a result, implementing policies to mitigate these impacts should be a priority. in africa, user fee exemption policies or other free care policies (fcps) have been a popular approach to incentivise health service utilisation, especially in the use of maternal and child healthcare services. however, studies have shown mixed evidence with regards to their effectiveness in various contexts. [ ] [ ] [ ] [ ] weak study designs, many of which lacked an adequate control group, may partially explain the mixed evidence. an evaluation of a previous fcp introduced in the democratic republic of congo (drc) in , unrelated to an evd outbreak, also demonstrated mixed results and the programme was not sustained. while fcps have been implemented in previous evd outbreaks in drc, to date, there have been no evaluations of their impact, where in addition to the usual concerns, additional challenges may further limit the effectiveness of such policies. fcps could provide benefits in two ways during an outbreak. first, it could encourage early identification and treatment of the disease itself-a factor that is believed to be a key predictor of ebola survivorship. second, it could help increase or maintain the use of other beneficial health services among the general population. based on the intervention theory of health user fee exemption policies developed by robert et al, a fcp should allow households to obtain health services that were previously unaffordable. however, in the context of an evd outbreak, fear of infection or a lack of trust in the health system may limit the demand for these services. in the evd outbreak in the equateur province of drc, the ministry of public health quickly implemented a temporary fcp in the three evd affected health zones as well as in four neighbouring health zones, primarily motivated by the first of the benefits described above. the implementation was supported by the ongoing health system strengthening for better maternal and child health results project funded by the world bank. in this paper, we evaluate the effect of the fcp on the use of health services at primary health centres (phcs) in equateur province using routinely collected administrative data. the drc is among the largest and most populous countries in africa and also has some of the worst health indicators in the region. the health system is highly decentralised and is challenged with very low levels of funding. to compensate, the health system relies heavily on user fees for financing. however, as over % of the population live in poverty, user fees represent a major barrier to health service utilisation. the drc has provinces which are subdivided into health zones. each health zone is further subdivided into health areas, each of which is equipped with health centres to provide primary health services. in , the drc experienced two separate evd outbreaks: the first happened in equateur province, followed by a second in the eastern region of the country a few months later. the first, which was declared on may , initially began in the ikoko-impenge health area in the bikoro health zone, where two cases of fever were confirmed to be evd and community deaths had been reported. by may , a total of cases and deaths were reported, including probable cases from the iboko and wangata health zones, a distance of nearly km, raising concerns of widespread transmission. in response to the outbreak, the drc ministry of public health, in partnership with the who, established a social awareness campaign and delivered personal protective equipment to the region by may . on may , vaccination campaigns were launched targeting front-line health workers, individuals exposed to confirmed evd cases and contacts of these individuals. additionally, to encourage people at risk to seek medical care and improve surveillance in the community, the ministry of public health implemented a temporary fcp in the health areas affected by the evd epidemic as well as in nearby health zones, beginning in june . the outbreak infected a total of people and led to deaths, including two health workers, before being declared over on july , with cases remained localised to the three health zones. we conducted a retrospective, controlled interrupted time-series (its) study using monthly data to estimate changes in the level and trend in the rate of health service utilisation between january and january at phcs during the equateur province outbreak. controlled its is a very strong quasi-experimental study design that can be used with routinely collected health system data. within equateur province, cases of evd were reported in of the health zones: bikoro (rural), iboko (rural) and wangata (urban). along with these affected zones, four neighbouring health zones (bolenge, ingende, ntondo and mbandaka) also received the fcp, bmj global health which was in effect between june and september (figure ). fcp covered consultations and medications for evd and other health conditions in the targeted areas. payments were made from the government to public health facilities (health centres and hospitals) to support the health workers and the maintenance of the facilities, using an existing payment platform that had previously been established to support a results-based financing programme in the area. the government also distributed medicines covered by the fcp to public facilities. we confirmed the enactment and implementation dates of the fcp with both provincial health administrators and local healthcare workers in equateur province. we extracted monthly data from the health management information system (hmis), an national electronic data collection system based on the district health information system (dhis ) platform. data in this system are input from health facilities' monthly health service use reports at district health offices. significant efforts have been launched in the drc to improve the quality of hmis data, including continual quality assessment activities at both the health zone and facility levels and incentives for report submission and completion. hmis data have been used to retroactively evaluate the impact of the west african evd outbreak on health service utilisation, and to evaluate the impact of other policies in other low-income and middle-income countries contexts using its analysis. for each phc, we extracted the number of visits for the following health services: . overall: ( ) total clinic visits. each health facility reported each of the indicators on a monthly basis. to enable comparisons between health zones, monthly counts were modelled as per-capita monthly rates using the estimated catchment populations for each facility reported in the hmis. these indicators were selected as they represent the majority of health services delivered in phcs ( % of total visits) and had the highest level of data completeness. although routine immunisations and malaria rapid diagnostic testing had been curtailed during the outbreak due to evd transmission concerns, we included these indicators to monitor the overall use of health services in the general population in the context of the evd outbreak. the research protocol was approved by the ethics committees at wilfrid laurier university (canada) and kinshasa school of public health (drc). we tested the following hypotheses: ( ) was the fcp associated with significant changes in health services utilisation at phcs in both evd affected and non-evd affected health zones? if so, what were the magnitude of these changes? ( ) were the changes in health service utilisation sustained throughout the period of the fcp bmj global health implementation and afterwards? ( ) were there any differential effects of the fcp in evd vs non-evd health zones? ( ) were some health services more affected by the fcp than others? our analysis included the phcs in two intervention groups that received the fcp: three evd affected health zones (evd and fcp), as well as in the four neighbouring health zones that received the fcp but were not directly affected by evd (fcp only). phcs in the remaining health zones within equateur province were included as the control group (neither). we fit our models using a two-level mixed-effects negative binomial model to adjust for the clustering of observations from the same health centres over time, and to correct for over-dispersion. all of our models included random intercepts for clinic in order to account for heterogeneity of clinic visit volumes, and an autoregressive structure of one period to account for potential correlation between observations over time. we defined three time periods: pre-intervention (january -march ), intervention (june-september ) and post-intervention (october -january ) based on the timing of the fcp. we excluded the first months of the outbreak (april and may ) from our analysis, as the time period between the onset of the outbreak and the implementation of the fcp was too short to independently test for time trends. each indicator was analysed for level and slope over time, changes in immediate (level) and gradual (slope) in the intervention and post-intervention period, and the interaction of these changes with the different study groups (evd and fcp, fcp only, neither). phcs were excluded from each analysis if data were missing for two or more consecutive months in either the pre-fcp (october and march ), or during evd and fcp (april and september ) periods. thus, we excluded phcs from one health zone (makanza) that had neither evd nor fcp due to lack of consistent reporting. we identified outliers and excluded a phc for a specific indicator if their reported data exceeded eight sd from the mean time trend (< . % of the sample). due to this rule about missing data, number of phcs included in each study group varied by indicator. the samples of phcs for each indicator is included in online supplementary table s a and s b. we then conducted separate controlled its analysis for each of the nine indicators. missing data were accounted for using standard maximum likelihood estimation in the mixed-effects models. additionally, in order to estimate the absolute change of each outcome compared to the counterfactual estimate without the fcp, we used the non-linear (exponential) combination of estimate parameters from the two-level mixed-effects negative binomial model and applied bootstrapping method to construct confidence intervals around the predicted absolute changes in outcome. we simulated data based on the estimates with normally distributed error using bootstrap statistics with resamples within each group. all analyses were conducted using sas v. . . this research was done without patient involvement. patients were not invited to comment on the study design and were not consulted to develop patient relevant outcomes or interpret the results. patients were not invited to contribute to the writing or editing of this document for readability or accuracy. as shown in table , we found that the fcp was associated with changes in the utilisation of many types of services, majority were similar in both the health zones with evd and in neighbouring health zones with fcp only. overall relative to control health zones, rates of total clinic visits increased substantially in fcp health zones following the start of the evd outbreak and we see similar increases in both the evd and fcp health zones and the fcp-only health zones. as shown in figure , visit rates increased more than twofold in evd and fcp health zones (incidence rate ratio ( similar to overall clinic visits, the fcp was associated with a large increase in visits for pneumonia and diarrhoea, and to a smaller extent for malaria visits. figure shows the model results for the rate of clinic visits for pneumonia. compared to facilities in control health zones, clinic visits for pneumonia doubled at the beginning of fcp in evd and fcp health zones (irr: . , % ci: . - . , p< . ) and quadrupled in fcp-only health zones (irr: . , % ci: . - . , p< . ). during the implementation period, visits for pneumonia in evd and fcp health zones had no significant change (irr: . , % ci: . - . , p= . ) while the rate decreased over time in fcp-only health zones (irr: . , % ci: . - . , p< . ). following the end of the fcp, the level of pneumonia visits decreased by % in evd and fcp health zones (p= . ), with no significant difference in the trend in subsequent months (irr: . , % ci: . - . , p= . ). the % decrease in fcp-only health zones was not statistically significant (irr: . , % ci: . - . , p= . ) and the trend reversed after the end of the policy (irr: . , % ci: . - . , p< . ). changes in the levels and trends of visits for diarrhoea following bmj global health the fcp had a comparatively moderate effect on the utilisation of maternal health services both in the evd and fcp health zones and the fcp-only health zones which varied by service type. figure shows vaccination figure shows the results for the administration of first doses of the dtp vaccine. reporting of routine immunisation in the evd and fcp health zones was predominantly from the wangata health zone. compared to control health zones, dtp immunisation had no significant change in the evd and fcp health zones (evd and fcp: irr: . , % ci: . - . , p= . ) and marginal increase in fcp-only health zones (irr: . , % ci: . - . , p= . ). no significant changes were found in the trends nor level after the fcp ended. discussion during disease outbreaks, maintaining the use of health services is important both for diagnosing diseases and ensuring continuity of care for other health issues. we found strong evidence that a fcp implemented in the drc during an ongoing evd outbreak associated with large increases in the rate of utilisation of health services in phcs. the magnitude of this increase was similar in the evd zones compared to neighbouring zones with the fcp but no evd. our findings are consistent with previous studies that found short term effects of fcps in other african contexts, but in stark contrast to the finding that fear and a lack of trust greatly curbed health service utilisation in the west african evd outbreak. despite the increase in the use of health services, the fcp was not equally effective for all indicators. the largest increase was observed in curative visits for pneumonia and diarrhoea, while increases in the treatment of malaria were observed only in the fcp-only zones. preventative services such as first antenatal visit and institutional delivery showed more modest increases. this pattern generally aligns with other fcp studies that have shown greater effectiveness for curative services than preventative services. studies from west africa also suggest the use of curative services recovered and rebounded earlier in the post-outbreak period, compared to preventative services. due to the concern of evd transmission, health facilities may have curbed the delivery of services that involved needles or blood extraction. indeed, the chief medical officer of bikoro health zone reported that evd responders recommended that, during the epidemic, routine immunisation, elective surgeries and malaria rapid diagnostic testing be curbed in the epicentre health zones (dr b loleka, oral communication, may ). the restriction in routine immunisation in the epicentre may have also contributed to reduced reporting on immunisation and malaria diagnosis during the evd outbreak. although these services were not targeted by the fcp, we found some evidence that dtp vaccination and malaria diagnosis did not decrease during the evd period in the reporting phcs, suggesting that such activities were maintained in areas outside of the evd epicentre. our findings also highlight some potential challenges in implementing fcps. the rapid increases in the use of services following the implementation of the policy attenuated over the following months which may be a result of the disruption of the fcp on the local health system. in particular, the sudden increase in demand for primary health services may have overstretched the limited human resources, or disrupted regular operations due to the changes in reimbursements paid to health workers and budgetary constraints during the fcp implementation. these impacts should be considered in future uses of fcp-type policies designed to mitigate the impact of infectious disease outbreaks. our findings also provide some insights that could be useful to decision-makers contemplating setting up similar policies in other infectious disease outbreak contexts, for example, countries currently deciding how to respond to the pandemic of covid- . first, we demonstrate that the policy was effective soon after implementation which was likely due in part to the presence of an existing payment structure that had previously been established in the region and that could quickly be leveraged for this programme. without such a platform, it may be challenging for other countries to implement such a policy in a rapid manner. second, while the intent had always been for the policy to be temporary, our findings suggests that the effectiveness of the policy began to wane soon after implementation, potentially as a result of the lack of longer-term planning. decision-makers should try to better balance the need for short-term effectiveness with the sustainability of the policy, in particular when it is uncertain at the onset how long an outbreak will last. our study has a number of limitations that should be considered when interpreting our results. first, our sample included only health centres and did not include all health facilities. as health centres are the formal health system structure that provide primary health services, we did not include health posts, which provide mainly community health services and health promotion activities. our sample also excluded hospitals and private health facilities. as private facilities are not directly governed by the ministry of public health, their reporting of routine health data is limited. it was not possible for us to include hospitals as their reporting in some health zones was very inconsistent during the outbreak. however, in the appendix we present data from select hospitals and note that similar increases in use of health services were also observed. second, there was a small increase in missing data during the first few months of the evd outbreak, particularly in vaccination and malaria diagnosis. as we excluded health centres with consecutive missing data in this period, our samples for these two indicators did not include all evd health zones. hence, our findings on vaccination and visits for malaria diagnosis may not be generalisable to the entire evd outbreak area. third, we were unable to include an estimate of the level and trend changes following the ebola outbreak as there were only months between the outbreak and the start of the fcp. finally, it is possible that the intervention may have had led to some spillover effects into neighbouring health zones which we are not able to fully control for in our analysis. however, the challenging terrain and large distances to health facilities may have limited spillover effects. plus, if such spillover effects had happened, it is unclear which direction they would have gone, and could have even made it less likely that we were to find an effect. in conclusion, our study demonstrates that the introduction of a fcp was strongly associated with rapid increases in the use of health services, in particular in zones with both the policy and evd. this is in contrast to prior evd outbreaks, wherein countries did not implement fcps at scale and saw large declines in the use of health services, suggesting that such policies may be effective at mitigating the impact of future evd outbreaks. however, the increases were not uniform across all health services and the rapid increases in the use of health services did not continue over the full fcp period. fcps may be an effective way to mitigate the impact of future outbreaks, including the current pandemic of covid- that is now threatening many countries including the drc, on population health, however, more research is needed to better understand the impact in different contexts and how such policies can be effective over time. access to all the data in the study and had final responsibility for the decision to submit for publication. disclaimer the funders of the study had no role in study design, data collection, data analysis, interpretation of data, or writing of the report. map disclaimer the depiction of boundaries on this map does not imply the expression of any opinion whatsoever on the part of bmj (or any member of its group) concerning the legal status of any country, territory, jurisdiction or area or of its authorities. this map is provided without any warranty of any kind, either express or implied. competing interests mrl has consulted for health canada, the health employees' union, the conference board of canada, and provided expert witness testimony for the attorney general of canada. bluesquare has ongoing contracts with a variety of organisations in drc including the ministry of health and the world bank. si, la-s, smm, and hr were paid as individual consultants as part of their collaboration with this project. patient and public involvement patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. provenance and peer review not commissioned; externally peer reviewed. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. orcid ids the - ebola virus disease outbreak and primary healthcare delivery in liberia: timeseries analyses for - the impact of the sars epidemic on the utilization of medical services: sars and the fear of sars women and babies are dying but not of ebola': the effect of the ebola virus epidemic on the availability, uptake and outcomes of maternal and newborn health services in sierra leone health-care access during the ebola virus epidemic in liberia patterns of demand for non-ebola health services during and after the ebola outbreak: panel survey evidence from community-based reports of morbidity, 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and the risk of measles and other childhood infections post-ebola a scoping review of the literature on the abolition of user fees in health care services in africa the impact of user fees on access to health services in low-and middle-income countries assessing the communitylevel impact of a decade of user fee policy shifts on health facility deliveries in kenya how effective and fair is user fee removal? evidence from zambia using a pooled synthetic control picking up the bill -improving health-care utilisation in the democratic republic of congo through user fee subsidisation: a before and after study building a middle-range theory of free public healthcare seeking in sub-saharan africa: a realist review brève situation de la riposte l'épidémie de la maladie virus ebola (mve) dans la province de l'equateur, république démocratique du congo au e jour [brief situation of ebola virus disease (evd) response in equateur province, democratic republic of c. kinshasa, democratic republic of 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epss - rapport final [democratic rebublic of congo evaluation of health services epss acknowledgements we acknowledge that this manuscript was prepared on the haldimand tract, traditional territory of the neutral, anishinaabe and haudenosaunee peoples. we are grateful to all of our key informants, including those in the democratic republic of congo (drc) and elsewhere to helping us obtain information on key parameters related to the outbreak. we also acknowledge qamar mahmood and sofia rossell at international development research centre for their support, jess wilhelm's research assistance on the project, and nicolas de borman's facilitation in facilitating the project and data access.contributors mrl, si, smm and kg conceived the idea. ywh, mrl, si, la-s, gl, smm, hr and kg developed the protocol and contributed to the study design. gl and ro provided study data and assisted with data management. ywh and lc managed and analysed the data, in collaboration with mrl. ywh and kg drafted the manuscript. all authors reviewed the manuscript and contributed to the revision of the manuscript, and approved its final version. the corresponding author had full michael r law http:// orcid. org/ - - - sharon abramowitz http:// orcid. org/ - - - lys alcayna-stevens http:// orcid. org/ - - - grégoire lurton http:// orcid. org/ - - - romain olekhnovitch http:// orcid. org/ - - - gabriel kyomba http:// orcid. org/ - - - hinda ruton http:// orcid. org/ - - - x karen a grépin http:// orcid. org/ - - - key: cord- -jgw nat authors: srinivas, prashanth nuggehalli; henriksson, dorcus kiwanuka; s gordeev, vladimir; decoster, kristof; topp, stephanie m; abimbola, seye title: “together we move a mountain”: celebrating a decade of the emerging voices for global health network date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: jgw nat nan it was otherwise an unremarkable november bus ride from antwerp to montreux; cold, but in the rather warm company of early career researchers who were to soon become the first cohort of emerging voices for global health (ev gh; http://www. ev gh. net). on that ride, early career health system researchers from countries began a journey. little did they know it would continue for over a decade, gathering in its wake, more early career researchers from countries, overwhelmingly from the global south. the ev gh programme has come a long way, from the first meeting at the annual colloquium of institute of tropical medicine, antwerp, belgium, and the subsequent road trip from antwerp to the first global symposium on health systems research at montreux, switzerland. ev gh began as a leadership and capacitybuilding programme incubated within the institute of tropical medicine, antwerp (itm-a) by a team led by professor wim van damme. with an explicit commitment to switching the poles (between the global north to the global south), the team at itm-a sought to design a unique programme to provide early career researchers with communication skills to critically examine global health agendas and events, and more importantly to not become passive consumers of evidence in global health events (such as the one that was, at the time, coming up in montreux). this was a disruptive idea. early career researchers typically enter global events in awe of the authoritative and prominent names featured in keynotes and panels. indeed, the first ev gh programme began by acknowledging the elderly white male high-income country dominance of the global health agenda. the programme wanted to do something about it, beginning at that first symposium in montreux. this year, , marks the th year of this programme and offers an opportunity to look back and look within. in this editorial, alumni and members of the ev gh globally representative elected governance entity share a brief historical overview of the network and subsequently summarise reflections of alumni across all six cohorts till date. the ev gh programme deliberately selects a cohort of - early career researchers in health systems, living or working in lowincome and middle-income countries and with an interest to engage critically on global health issues that have local relevance within their country/local health systems. while scientific merit and excellence have shaped the selection, ev gh peer reviewers and selection committees have rarely relied purely on scientific achievements. an explicit eye for candidates who have a history of critical policy and/or community engagement and ensuring a mix in each cohort of gender, geographical regions and nature of experience with health systems has guided the selection in addition to academic excellence and achievements. each ev gh cohort receives - weeks distance learning programme. participants get to know each other and engage in vibrant discussion and debates on global health topics related to the upcoming health systems research symposium. they also receive interactive online training designed to improve communication skills in oral presentations and posters through design inputs and critical peer review. the ev gh programme has bmj global health built skills that are often not part of university curricula, especially focusing on effective communication in oral presentations, panel discussions and framing and posing questions in meetings and global health events. rather than being taught, often, what participants have found beneficial is the opportunity to develop these skills within an engaging peer-steered learning environment that the programme offers. after going through the ev gh programme, participants have often continued to engage with fellow ev gh alumni in collaborative blogs and opinion pieces often in the international health policies newsletter or on one of several blog platforms offered by international global health journals. these pieces have often sparked critical discussions in countries or regions which participants find to be a strength of the network. participants' skill to confidently speak on global health issues on social media platforms or among colleagues in-country improved through the programme. at the time the ev gh programme was being birthed, the health systems research community was actively involved in field-building activities, trying to raise the profile of what has today come to be recognised as a coherent field-health policy and systems research (hpsr). under the leadership of various global health actors and the who alliance for health policy and systems research, efforts were being made to bring together a society of practitioners of health policy and systems research. the global hpsr community grew from strength-tostrength and eventually launched a society of its own, health systems global (hsg). a biennial global symposium is hosted by hsg as a platform for exchange and community-building, with an explicit focus on peoplecentred health systems, action on social inequalities by addressing the social and political determinants of health, engaging with a wide variety of biomedical, social science and humanities approaches to strengthening health systems and leadership embedded in the global south. ev gh had begun to organically coalesce around these values, such that when hsg announced the possibility of becoming one of its thematic working groups in , ev gh found a home within hsg, while retaining its identity. as the global symposia on health systems research was being hosted from one hpsr centre of excellence to another (beijing, cape town, vancouver and liverpool), ev gh invited universities and institutions, many of them in the global south, to become member organisations of the ev gh network. with a desire to further acquire a more global character and egged on by itm-a to not feel rooted within one high-income country institution, between and , the ev gh established a globally representative governance structure. this governance structure has ev gh representatives from each of the six who regions in a governance committee and with a secretariat established at one of the ev gh member institutes, the institute of public health, bangalore. following each biennial ev gh venture, participants join an email discussion group that serves as a common platform to be in touch with participants from all cohorts. other interested global health researchers are also welcomed to join this open email discussion group. the discussion group serves as a bulletin board for tracking global health events and commentary. it is often the place where collaborative opinion pieces and blogs by ev gh alumni begin. ev gh alumni work with peers rather than with supervisors and this improves their confidence and enables collaborative and multidisciplinary engagements. for many ev gh alumni, being a member of this network has helped them to raise their voice locally and speak with confidence on how global forces could be influencing local change within their settings. the collective engagement every years during the biennial global health systems symposia enables community-building and several ev gh alumni have taken on leadership roles within our network and within the broader hpsr community and beyond. some have become elected members of the hsg board, and others have taken the lead in managing other thematic working groups within hsg, and many others participate actively in other regional and global events while coordinating with fellow ev gh alumni in such fora, leveraging the membership in the network to seek wider change in the health systems and global health community. possibly, the most important take-away message for the ev gh has been the emphasis on the nature of change that the network seeks at local, national, regional and global levels. over the years, the network has nurtured a focus on equity and action on social determinants of health. an equity focus has been embedded in the programmes of various cohorts, including through application of a gender and power lenses, and a more recent focus on climate change and on fragile and conflict affected states. ev gh alumni have continued to apply these lenses to their work in other aspects of health, and as part of a larger advocacy goal that they take on after the programme. given its growth over the years, many ev gh alumni from early cohorts are today established researchers themselves (with a few practitioners, policymakers and advocates as well). there are therefore increasing opportunities for mentorship in-house. either because of a lack of secure funding commitments, or due to the organic nature of its growth, it is likely that the ev gh network will remain informal, even as several alumni identify this as a possible weakness of the network. finding solutions for funding of ev gh without losing bmj global health its inherent flexibilities and getting co-opted to the extent that it becomes one of the usual suspects in global health is a challenge facing the ev gh leadership and a tension that needs to be worked out over the next years. the premise for developing the ev gh programme a decade ago was that global health symposia were plagued by presentations of poor quality and with limited attention to communicating messages to a truly global audience. to enliven, energise and make global health events more vibrant, to improve the global health dialogue and to ensure that they are participatory and truly inclusive of voices from the global south, ev gh programme and its diverse participants challenged head on the text-heavy powerpoint and expert-driven presentation formats, by integrating community voices and prioritising participatory formats like fish-bowls, helping foreground real-world issues and provide a global-south orientation. and indeed, hsg itself, and the organising leadership of subsequent global symposia on health systems research-in beijing ( ), cape town ( ), vancouver ( ) and liverpool ( )-welcomed this changing format. as we prepare for the next symposium in dubai ( ), it is clear that the global hpsr community has come a long way in accepting the need for debate and dialogue on the best ways for challenging the norms and structures that shape social inequalities from the global to the local. with the covid- pandemic continuing unabated in many parts of the globe, the unfinished agenda on multiple fronts ranging from health systems to the sdgs casts a shadow on the response. amid such uncertainty, there is one clear agenda still waiting on the other side of this pandemic; in an era of physical distancing, how to stick together is an important challenge facing the health research community. looking back at the past decade of ev gh, we seek to reaffirm its promise of continuing to incubate disruptive and critical early career leadership within global health. together we move a mountain. long may it continue! contributors all authors participated in the conceptualisation of the article. nsp, dkh, vsg and kd wrote the first draft, and smt, kd and sa reviewed and provided comments. all authors reviewed funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors competing interests all authors (except kd) are alumni of the emerging voices for global health network. nsp, dkh and vsg are either current or earlier elected members of the governing group of the network. all authors have been earlier or currently involved in supporting the network in voluntary capacities provenance and peer review not commissioned; internally peer reviewed. data availability statement no additional data are available open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial health systems global, the new international society for health systems research acknowledgements the ev gh network ( www. ev gh. net) is very grateful to prof. wim van damme and david hercot, who initiated the venture years ago, the many people (aka 'friends of ev') who have generously supported the programme over the years in various ways, the ev secretariat staff at iph in recent years (pragati hebbar, ketki shah, diljith kannan), secretariat staff of partner institutes and co-hosts, including itm (and annelies de potter in particular). the authors would like to thank nityasri sn from the ev gh secretariat in iph, bangalore for steering the process towards this article. the authors would also like to thank generous funders and supporters over the past years, with a special mention for the belgian development cooperation (dgd) and hsg who have been very supportive throughout these years. last but not least, the ev network would not be what it is now without the enthusiasm of the many ev alumni who have together 'moved a mountain' over the past years, and will no doubt continue to do so in the future. key: cord- -cpub oah authors: d’cunha, colin title: sars: lessons learned from a provincial perspective date: - - journal: canadian journal of public health doi: . /bf sha: doc_id: cord_uid: cpub oah nan t o say that sars was a unique threat, and one that challenged public health and the entire health system in ontario could be viewed as somewhat of an understatement. never had the modern public health or the health care system been put to such a test or been put under such pressure to respond as during the two phases of sars outbreaks earlier this year. the very uniqueness and stress that the sars outbreaks placed on our system inevitably revealed the weaknesses and the areas where change or fortification in our public health defenses was needed in order for us to meet successfully future challenges. in ontario, public health services are delivered locally by public health units. funding for public health services in ontario is based on a mixed model with municipal and provincial partners contributing to the funding. while funding is referred to as " / ", in actual fact, the province matches the municipal contribution, and goes further. an additional - % of funding is made available through the community reinvestment fund to offset the increase in municipal costs over the base year. the total funding for the public health sector has gone up by % over years. sars provides an opportunity for a re-examination of the funding arrangement as some local health units have had difficulty in obtaining funding at the municipal level. the absence of surge capacity, locally, provincially and nationally, in public health infrastructure came to the forefront during the outbreak. while many individuals volunteered for the response, other public health functions that they were engaged in had to be put on the back burner. the area of public health human resources has been the subject of many studies since . creating extra capacity takes time as public health professionals take a few years to train. for instance, a fully qualified public health nurse takes years to train, a public health inspector years, a public health physician years post graduation. therefore aggressive investment and strategic planning is needed to meet public health human resource needs. a cadre of trained communicable disease investigators has to be nurtured and made available for deployment on an ongoing basis. other public health professionals should be cross-trained in communicable disease management to create additional surge capacity. epidemiological training is offered nationally through health canada. during the outbreak, the immigrant health resources pool was used successfully. the vast majority of the two provincial rapid response teams assembled were international medical graduates at differing stages on the pathway to qualifying as physicians in ontario/canada. some of these individuals are now considering public health as a career. in ontario, the information technology system in place since the late s was the reportable disease information system (rdis). nothing came of the efforts of a steering committee who undertook to modernize this system in the mid s. the arrival of the integrated public health information system (iphis) at the turn of the millennium aroused an interest in ontario, and a formal commitment to its rollout was made in the spring of . implementation was planned for the spring of on a staggered basis. sars challenged the planned start up. however, an iphis module was developed and used in april during the sars outbreak. at the time of writing, british columbia (where iphis was developed) is evaluating the sars iphis module developed in ontario. modernizing the public health information platform on a regular basis is critical for public health workers regardless of the setting they work in. dedicated funding and staff to evaluate, plan and integrate new changes have to be in place. some of the delays in data transfer between public health agencies can be mitigated with webbased technology. giving different users access to different fields with appropriate safeguards can alleviate privacy concerns. the public health platform developed and used should ideally have the capacity to interact with other systems in society. as public health is all-encompassing, the public health platform for example should be able to access census, economic, environmental, financial and other significant health data. the use of sentinel events in non-human populations cannot be understated. a practical success story is the west nile virus surveillance system where bird and mosquito surveillance served as an early warning system. the global public health intelligence network (gphin) system that scans raw newswire feed provides valuable alerts for influenza pandemic surveillance, based on events around the world. the use of non-prescription drugs can also be used as a sentinel for other conditions. analysis of the sales of diarrheal medications in two communities (saskatchewan and wisconsin ) preceded the discovery of waterborne outbreaks there. clinical interface is also important. strong relationships between public health and our clinical colleagues promote early identification and reporting of public health threats. the median delay in reporting data sets from the field to public health officials was days (with a range from to days). there was a further delay in reporting to the ministry of health and long-term care. the median of the additional delay period was days (with an average of . days). the health protection and promotion act ed within their statutes to monitor and control disease outbreaks, and that adding new, emerging infectious diseases to the legislative scheme may be done quickly and efficiently. the hppa was recently amended to empower the courts to order isolation of individuals in appropriate institutions other than hospitals, where the legal test is met, under section of the act. the hppa also allowed the minister, under section , to order the occupier of any premises to deliver possession of all or part of any facility he or she specified for use as a temporary isolation facility. the new amendment provides that the chief medical officer of health, rather than a medical officer of health, may certify to the minister that the premises are needed for use as a temporary isolation facility anywhere in ontario, for a period of not more than months. in addition, the act was amended to allow a medical officer of health to make a "communicable disease order" under section of the act respecting an entire class of persons, where notice to each member of the class is likely to significantly increase the risk to the health of any person. communication was a focal point; there was a need to communicate with health professionals and the public. although much effort was made to provide open and transparent communications, the result was mixed reviews. communicating during a crisis was a challenge and should never be underestimated. the media has to play an effective role in getting key messages out without being alarmist. in this age of electronic communication, it became obvious that the international world was also monitoring the media to keep abreast of latest developments. communications with stakeholders, in particular health professionals, is a formidable challenge. many if not all health professionals are not electronically linked, thus posing delays in getting key information out in a timely fashion. multiple communication strategies have to be implemented to overcome this hurdle, such as the use of e-mail, fax, paper, web-based and other modalities. sars brought home to health care colleagues the reality that nosocomial infections put them at personal risk. in the early stages, it was apparent that even some procedures as basic as handwashing were not practiced adequately. reinforcing the message to handwash helped increase compliance with this very basic infection control practice. risk assessments have to be done at the system, institution and individual level so that the best and most appropriate level of protection is followed. using the correct approach minimizes the risk of the health care individual being personally infected or carrying it to others. the use of appropriate barriers and precautions has to be continually reinforced at periodic intervals. any new lessons learned have to be incorporated with minimal delay. basic and applied research must be fostered so that a disease's course may be fully understood and that the interventions proposed are necessary. an evaluation of the efforts directed at responding to the outbreak should be conducted. this allows for better preparation for the future. public health emergency preparedness is critical. tabletop and other exercises allow for key players to interact regularly, understand each other's roles and build strong dynamic relationships that mitigate the stress invariably experienced during a crisis. to successfully benefit from the lessons learned requires the commitment and the investment of all levels of government that are responsible for public health. skills enhancement for the health surveillance program, centre for surveillance coordination public health information strategy advisory committee (phisac) personal communication with dr waterborne cryptosporidiosis outbreak assessing the public health threat associated with waterborne cryptosporidiosis: report of a workshop ministry of health and long-term care line list learning from sars: renewal of public health in canada. a report of the national advisory committee on sars and public health key: cord- -naromr a authors: mcleish, caitriona title: evolving biosecurity frameworks date: - - journal: the palgrave handbook of security, risk and intelligence doi: . / - - - - _ sha: doc_id: cord_uid: naromr a the relationship between infectious disease and security concerns has undergone an evolution since the end of the cold war. what was previously seen as two separate domains – public health and national security – have, through various events and disease outbreaks in the last years, become intertwined and as a result biosecurity policies now need to address a spectrum of disease threats that encompass natural outbreaks, accidental releases and the deliberate use of disease as weapons. in the last decade of the twentieth century, particular concern began to be expressed that globalisation was facilitating the spread of infectious disease. in for example the us institute of medicine issued a report which warned "some infectious diseases that now affect people in other parts of the world represent potential threats to the united states because of global interdependence, modern transportation, trade and changing social and cultural patterns" (lederberg et al, , pv) . framing infectious disease in this way was part of a growing appreciation that a series of new security challenges, such as terrorism, drug trafficking, and environmental degradation, were supplanting the more traditional state centric national security concerns of the cold war era. (brower and chalk, ) as remarked upon by james woolsey during his nomination hearing for director of the central intelligence agency in : "in many ways today's threats are harder to observe and understand . . . yes, we have slain a large dragon, but now find ourselves living in a jungle with a bewildering number of poisonous snakes" (woolsey, , p ) . the intelligence community had first taken up the issue of the threat posed by infectious disease in the s in relation to hiv/aids (cia, ) . however a declassified national intelligence estimate from january expanded the scope of diseases that might pose security concerns. the report noted, for example, that since at least thirty previously unknown diseases had been identified and at least twenty older infectious diseases had re-emerged or spread geographically over the same period frequently in drug resistant form. the authors of the report believed that "the spread of infectious diseases results as much from changes in human behaviourincluding lifestyles and land use patterns, increased trade and travel, and inappropriate use of antibiotic drugs-as from mutations in pathogens" and suggested that, new and re-emerging infectious diseases will pose a rising global health threat and will complicate us and global security over the next years. these diseases will endanger us citizens at home and abroad, threaten us armed forces deployed overseas, and exacerbate social and political instability in key countries and regions in which the united states has significant interests. (nic, ) what prompted the release of this national intelligence estimate was the announcement by the then us secretary of state madeline albright that the first un security council session of the new millennium would be devoted exclusively to the threat to africa from hiv/aids. whilst this session is often remarked upon for ultimately leading to resolution on the responsibility of the security council in the maintenance of international peace and security: hiv/aids and international peace-keeping operations, it was the discussions within the session that did much to characterise the evolving nature of the relationship between infectious disease and security concerns. un secretary general kofi annan, for example, noted that the impact of aids in africa was "no less destructive than that of warfare itself and by some measures it was far worse" and went on: nowhere else had aids become a threat to economic, social and political stability on the scale that it now was in southern and eastern africa . . . in already unstable societies . . . that cocktail of disasters was a sure recipe for more conflict. and conflict, in turn, provided fertile ground for further infections. the breakdown of health and education services, the obstruction of humanitarian assistance, the displacement of whole populations and a high infection rate among soldiers . . . all ensured that the epidemic spread ever further and faster. (unsc, ) as president of the security council during this session, us vice-president al gore noted that the links being articulated between hiv/aids and insecurity presented an opportunity to recast the work of the security council for the new century. with echoes of woolsey's comments at his nomination hearing for cia director seven years earlier, gore is reported to have said that for the past years the security council: had dealt with a classic security agenda built upon common efforts to resist aggression, and to stop armed conflict. but while the old threats still faced the global community, there were new forces that now or soon would challenge the international order, raising issues of peace and war . . . includ[ing] the challenges of: the environment; drugs and corruption; terror; and new pandemics. (ibid) three months later, in april , president clinton took the unprecedented step of designating an infectious disease (aids) a threat to us national security (gellman, , pa ) taken together, these actions signalled a "securitization" (buzan et al, ) of infectious disease that resulted in greater political interest and access to larger economic resources so as to tackle to issue on a global scale. in line with the "securitization" thesis, political interest in hiv/ aids has remained high and superior financial resources have indeed been accessed. this included us president george w. bush promising $ billion over five years to international hiv/aids programmes in his state of the union speech. however, selgelid and enemark ( ) note that hiv/ aids is a disease of attrition, meaning that "the effects of these diseases are relatively familiar and slow-acting, they do not concentrate the minds of people and politicians as readily as an unfamiliar and sudden outbreak crisis." consequently it was growing anxiety over a perceived new type of terrorist that may deliberately use infectious disease to further their aims which gave further salience to the relationship between infectious disease and security concerns. the attacks on the world trade center and the pentagon on / fundamentally altered perceived societal vulnerability towards terrorist use of infectious disease. though the events themselves were quite unrelated to biological weapons (i.e. the hostile use of disease), the idea that non state actors, including terrorists, might seek to employ biological weapons to further their aims was lifted from (arguably) a niche concern to a mainstream security issue. calling it niche is not to say that bioterrorism had not been considered a security threat prior to many commentators had noted the potential (see for example stern, ; tucker, tucker, , moodie and roberts, ; smithson and levy, ) ; table top exercises had been conducted, domestic preparedness programmes initiated (guillemin, , p ) , and in countries such as the us, policy directives had been crafted that gave the highest priority to "developing effective capabilities to detect, prevent, defeat and manage the consequences of nuclear, biological or chemical materials or weapons use by terrorists" (united states, ) . however what the / attacks did was alter the global frame of reference about what terrorists writ large might now be prepared to undertake. the attacks appeared to suggest that what had been considered previously as restraining factors on terrorist actions, such as limiting casualties so as not to "risk of alienating the public especially their own supporters" were no longer valid (butler, , p ) . instead this new breed of terrorist and extremist appeared to want to cause casualties on a massive scale, and appeared undeterred by the fear of alienating the public, their own supporters, or indeed by considerations of personal survival. after the sheer destructiveness of / tucker ( ) notes that it was a logical next step for government officials to voice "fears that terrorists might unleash a devastating epidemic" as part of a second wave of attacks and in early october this hypothetical bioterrorism threat became a reality with the first death from inhalational anthrax in the us since . twenty-one others went on to be diagnosed with either inhalational or cutaneous forms of anthrax and five more people died. the source of the exposure was five letters containing anthrax spores anonymously posted to media outlets and members of the senate. coming so soon after the / attacks, these letters created a near hysterical atmosphere. tucker writes: cable news networks hyped the bioterrorism threat with apocalyptic scenarios; postal workers sorted mail wearing rubber gloves and surgical masks; thousands of senate staff members were put on prophylactic antibiotics; and letters addressed to government officials were irradiated with electron beams to kill lingering spores, delaying mail for weeks. meanwhile, tens of thousands of ordinary americans stockpiled ciprofloxacin (a potent antibiotic with potentially dangerous side effects), snapped up gas masks of questionable effectiveness from army supply stores and hoarded canned food and bottled water in anticipation of spreading epidemics and quarantines. (tucker, , p ) although the letters were only posted in the us, the anthrax letter attacks had global impact particularly because of the cognitive link that was made between biological weapons and the perpetrators of the / attacks. in europe for example, civil protection and security forces were put on alert, and public health systems had to deal with numerous items of mail containing powders suspected of being contaminated with anthrax. and at the political level, european countries acted at both the community level and national level. in october for example, the heads of state and government asked for a european level programme to be prepared to improve the cooperation between member states for the evaluation of risks, alerts, and intervention, and the collaboration in the field of research. at the national level many european countries re-examined their preparedness plans and strengthened or implemented new measures designed to prevent the misuse of the biological sciences. this included placing restrictions on physical access to, and work performed with, certain pathogens labelled as "dangerous." european states were not alone in re-examining their preparedness programmes: in the us for example, at least three new pieces of legislation were enacted in quick succession aimed at preventing the misuse of disease and they significantly increased their investment in bio-defences, including medical countermeasures. at the international level, the threat from the deliberate spreading of disease slotted neatly into the global "war on terror" that president bush had launched in the days following / . addressing the united nations general assembly in november bush described terrorists as searching for weapons of mass destruction, the tools to turn their hatred into holocaust. they can be expected to use chemical, biological and nuclear weapons the moment they are capable of doing so. no hint of conscience would prevent it. this threat cannot be ignored. this threat cannot be appeased. civilization, itself, the civilization we share, is threatened. (bush, ) consequently the global community also acted together to combat the threat from bioterrorism. this included a range of activities including "operational" initiatives such as the proliferation security initiative, the g global partnership against the spread of weapons and materials of mass destruction and the global health security initiative as well as broadening the mandate of international organisations such as the world health organisation such that they now had a role in responding to the "natural occurrence, accidental release or deliberate use of biological and chemical agents or radionuclear material that affect health." (wha, ) at the diplomatic level, the work of the biological weapons convention (bwc) now became focused on a broadened understanding of the threat posed by biological weapons, including the possibility of terrorist use of biological agents. the focus prior to had been state level adherence to the norms of the bwc. however if properly implemented at the national level, the convention addresses potential terrorist use by transferring the obligations that states agree tonot to develop, produce, manufacture or stockpile biological and toxin weapons or methods of delivery of such weaponsonto individuals in their territory or under their jurisdiction anywhere. when tabling a number of proposals for future work in late the us delegation noted that "many of these ideas will bear little resemblance to the traditional arms control measures of the past" including the negotiation of a legally binding verification protocol which had recently failed (us department of state, ). these alternative proposals eventually initiated an "intersessional process" where states parties to the bwc meet twice yearly to discuss, promote common understanding and achieve effective action on a number of topics related to this broadened understanding of biological threats. viewed within the bioterrorism/war on terror framing, the political significance of mitigating naturally occurring disease outbreaks was elevated by linking global health engagement with set of efforts to counter violent extremism and bring stability to conflict-prone areas (chreiten, ) . consequently, much of the engagement that took place was therefore focused on africa as home to a number of fragile states with porous borders and groups linked to al qaeda. concurrent with this terrorism-focused framing of the threats posed by infectious disease, another more human security focused framing of disease was forwarded in documents such as the united nations high level panel on threats challenges and change where the challenges of disease were presented as follows: the security of the most affluent state can be held hostage to the ability of the poorest state to contain an emerging disease. because international flight times are shorter than the incubation periods for many infectious diseases, any one of million international airline passengers every year can be an unwitting global disease-carrier. (anan, p ) part of the stimulus for framing of the threats from infectious disease as "without borders" came from the experiences of the severe acute respiratory syndrome (sars) outbreak. the sudden appearance of sars had, by the time the world health organisation (who) declared the outbreak contained in july , spread to countries on all continents, infected more than people and presented an % lethality rate. (who, ) unlike the apocalyptic "dread risk" scenarios for bioterrorism attacks in the same period, sars was a "dread reality": evidence showed sars to be a fast spreading disease that did not require a vector; symptoms appeared to begin an average of four days after exposure to an infected person and mimicked many common diseaseshigh fever, a dry cough and shortness of breath (who, ) and the disease showed no particular geographical affinity. indeed on this last point an association was made early on between sars and travel on commercial airlines (see for example olsen et al, ) which resulted in guidelines being issued regarding travel to and from areas affected by sars that focused on hand hygiene and specified that anyone suspected of having sars should wear a facemask. however, public perception of the risk of becoming infected with sars led to widespread use of facemasks whether on a flight or not (see for example hesketh, . fear of infection was therefore a potent ingredient in the sars epidemic: in toronto, canada, there were reports of "public bus drivers using face masks on routes near chinese communities and empty seats surrounding chinese university students" (schram, , p ) and at the height of the epidemic, despite only eight people in the us having laboratory evidence of sars, eichelberger ( ) notes that % of americans reported avoiding asian businesses. indeed across the us "restaurants, travel agencies and other businesses from new york to san francisco [reported] customer traffic is down by % or more" (hopkins, ) . as with the anthrax letters then, the effects of the sars epidemic were not confined to ill health, or to those countries directly affected. indeed, it was the economic repercussions of the outbreak that came to define the disease. one assessment for example, estimated the total cost of the epidemic to the asian regional economy at us$ billion in gross domestic product for , "that is, over us$ million per person infected by sars," with gross expenditure and business losses being estimated as high as us$ billion (rossi and walker, p - ) the authors also note that this was a shared economic burden whether the country reported infections or not because of the association between airline travel and infection. this is because as elbe ( ) notes the travel and tourism sectors in the region were heavily affected with "room and airline seat bookings to [the region] down in several cases by more than per cent compared to previous years." any lingering doubts about whether the trans-border spread of infectious diseases created security issues were removed by the sars outbreak. sars also drew attention to potential security implications of a wider set of emerging and re-emerging infectious diseases that could no longer be ignored. indeed quickly on the heels of sars epidemic, concern began to be expressed over the pandemic potential of h n avian influenza. sensitised to the potential of an influenza a type pandemic by the outbreak of h n , or "bird flu," fear was now being expressed that h n could mutate or combine with a human influenza virus to form a new virus, capable of sustained human-tohuman transmission (see for example lee and fidler, and who, ). writing in the new york times members of the senate committee on foreign relations, barak obama and richard lugar, framed the relationship between national security and an influenza pandemic as follows: when we think of major threats to our national security the first to come to mind are nuclear proliferation, rogue states and global terrorism. but another kind of threat lurks beyond our shores, one from nature not humansan avian flu pandemic. an outbreak could cause millions of deaths, destablize southeast asia . . . and threaten the security of governments around the world (obama and lugar, ) what h n did, elbe ( ) notes, was render the mere possibility of a future outbreak a sufficient condition for considering an infectious disease as a threat to security and so requiring investment and proactive pandemic preparedness. indeed in january , the international community pledged us$ . billion to fight avian influenza and prepare for a possible human pandemic (beijing declaration, ) . the un high level panel report quoted above also alludes to another vulnerability that was exposed during the sars outbreak, namely the deficiencies in the contemporary reporting system for infectious disease outbreaks. at the time, the who was prevented from responding to an outbreak until it had received official reports from governments (heymann, ) . in the case of sars, there was a three-month delay from onset until the who received official reports from the chinese ministry of health by which time there were over cases and the disease had spread to five countries. part of the inadequacy of that reporting system was the mismatch between the framework under which the who had to work, the international health regulations, and the tools that the who had at its disposal in . for example the who were unable to act despite having "epidemic intelligence networks" such as the global outbreak alert and response network (goarn) in place at the time of the sars outbreak that had picked up on an outbreak prior to the official notification. this intelligence had been gathered by goarn's early warning element which collects and verifies reports and rumours of epidemics from a wide variety of unofficial sources, including nongovernmental organisations, news media, electronic discussion groups such as the program for monitoring emerging diseases, and other official surveillance networks. when the who was eventually able to act, the response side of goarn was activated and within a period of weeks after the first recognised case, a virtual network of eleven leading infectious disease laboratories in nine countries had been established. connected by a secure website and daily teleconferences, the laboratories collaborated to identify the causative agent of sars and to develop a diagnostic test; similar groups were also created to pool clinical knowledge and compare epidemiological data on sars (knobler et al, ) . the who used this information to make recommendations on patient management which included issuing travel recommendations in an attempt to curb, and eventually stop, the international spread of this newly recognised virus (heymann, ) . perhaps the most important legacy of the sars epidemic, and to a lesser extent the h n outbreak, was the sense of urgency it gave to finalising the updates to the international health regulations (ihrs). begun in the mid- s, the revision process had two primary goals: to make use of modern communication technologies to understand where diseases were occurring and had the potential to spread, and to change the international norm for reporting infectious disease outbreaks so that countries were not only expected to report outbreaks, but also respected for doing so (heymann, ) the updates were completed in and went into effect in . amongst the many updates, the establishment of a global surveillance system for public health emergencies was critical. surveillance is defined in the revised ihrs as "the systematic on-going collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary" (who, ). the surveillance system operates from the local to the global level. at the national level each state party is now required to notify who of "all events which may constitute a public health emergency of international concern" including any unexpected or unusual public health event regardless of its origin or source and also requires state parties, as far as is practicable, to inform the who of public health risks identified outside their territories that may cause international disease spread. to assist in compliance with this obligation, the ihrs defines a public health emergency of international concern (pheic) as an extraordinary event which is determined [by the who director-general] . . . (i) to constitute a public health risk to other states through the international spread of disease and (ii) to potentially require a coordinated international response. (ibid) and defines disease as an illness or medical condition irrespective of origin or source, that presents or could present significant harm to humans that does or could threaten human health. (ibid) a decision-tree to assist state parties in defining whether a health related event is a pheic is included, so too a list of diseases for which a single case may constitute a pheic and so must be reported to the who immediately. this list consists of smallpox, poliomyelitis, human influenza caused by new subtypes, and sars. arguably, as a direct result of perceived reluctance on the part of the chinese authorities to be transparent in the early stages of the sars outbreak, the revised ihrs state that the who can collect, analyse and use information "other than notifications or consultations" including from intergovernmental organisations, nongovernmental organisations and actors, and the internet. furthermore the who can now act upon the information gathered by requesting "verification from the state party in whose territory the event is allegedly occurring." when so requested, the state party has hours to give an initial reply to the who, or acknowledge the request from them, and if possible provide the who with available information on the status of the event referred to in the request. this is done through the newly required national focal point for the ihrs, a role established to ease communication between the who and the state party. in permitting the who to act upon that information and requiring states to perform some form of action within hours of that request, the principle of national sovereignty became subordinate to the collective interests of global disease surveillance. this had stalled the revision process, but as katz and fischer ( ) note the "sudden fear of the consequences of a single nation's failure to report an emerging infectionwhether due to lack of will or capacityovercame many of the concerns about sovereignty." although nowhere in the revised ihrs is the word "intentional" or "deliberate" used the scope of the definition of disease within the revised ihrs and the newly expanded role of the who with regard to deliberate disease outbreaks mean that the ihrs do encompass communicable and non-communicable disease events, whether naturally occurring, accidentally caused, or intentionally created. in part, this is because whether deliberate, accidental or naturally occurring, the initial response to the outbreak would be the same, meaning that early warning systems, indeed in general strong public health systems, serve multiple purposes. at the time of writing the ihrs have been in force for nine years and there have been four declared public health emergencies of international concern, including the ebola virus outbreak in west africa, declared a pheic on august . between march , when the outbreak was first reported, and march when the the who director-general declared the pheic at an end the total number of reported cases in the three worst affected countries (guinea, liberia and sierra leone) was , . a small number of cases were also reported in nigeria and mali and a single case reported in senegal; however, these cases were contained, with no further spread in these countries. in addition there were a small number of exported cases in spain ( case); the united states ( cases); the united kingdom ( case) and italy ( case). a review of who's response to this ebola outbreak characterised it as "the most complex outbreak on record . . . [which] devastated families and communities, compromised essential civic and health services, weakened economies . . . isolated affected populations . . . [and] put enormous strain on national and international response capacities, including who's outbreak and emergency response structures" (who, ) . indeed, the strain was such that the international response to the outbreak included the establishment of the first ever united nations emergency health mission, the united nations mission for emergency ebola response or unmeer, after the unanimous adoption of general assembly resolutions / and / , and the adoption of security council resolution ( ) on the ebola outbreak. whilst the idea that health issues and security are linked was by now firmly embedded within the international political consciousness and that response to outbreaks were considered both a national and international responsibility, the ebola outbreak served to highlight a significant mismatch between those ideas and practical realities. the review of the who's response noted above was extremely critical of the response effort on a number of levels. regarding the actions of the who itself, the panel's assessment regarded there to have been "significant and unjustifiable delays" in declaring the ebola outbreak a public health emergency of international concern, despite early warnings about the outbreak from its own staff and from non governmental organisations such as médecins sans frontières, and that the "who does not currently possess the capacity or organizational culture to deliver a full emergency public health response" (who, , p ) . part of the reason for this is that there are no core funds for emergency response and the panel recommended the immediate creation of a contingency fund in support of outbreak response as well as the establishment of a who centre for emergency preparedness and response which would develop the necessary new structures and procedures to achieve full preparedness and response capacity. considering the outbreak in terms of the revised ihrs, the panel also noted that nearly a quarter of who's member states "in violation of the regulations," instituted travel bans and other additional measures not called for by who, "which significantly interfered with international travel, causing negative political, economic and social consequences for the affected countries" (ibid, p ). the panel went on to say that they consider the situation "in which the global community does not take seriously its obligations under the international health regulations ( )a legally binding documentto be untenable" (ibid). implementation statistics for the revised ihrs do indeed demonstrate that many states have had difficulties in implementing what is required of them in this new system. all states were to have the new national core surveillance capabilities in place by june ; however, by that deadline less than % of the who member statesthat is statesreported they had achieved the core capacities; countries requested and obtained an additional two year extension and countries neither submitted an extension request nor indicated that they are in compliance (katz and fischer, , p ) . at the end of the second two-year extension period the who executive board noted that only an additional states ( nations in total) reported that they had fully implemented the revised ihrs (world health organisation, ) . in part to redress these implementation difficulties, the us in partnership with about other countries, ios, ngos and public/private enterprises launched the global health security agenda (ghsa) in february . the ghsa has discrete action packages under the three cluster heading of "prevent, detect and respond" covering issue areas such as antimicrobial resistance, zoonotic diseases, real time surveillance and reporting. eight of these packages relate in whole to the revised ihrs and a package is also specifically dedicated to improving biosafety and biosecurity systems and preventing bioterrorism. the spectrum of issues being addressed by the global health security agenda reflects the evolution of biosecurity issues since the end of the cold war. what had previously been considered as two separate domainspublic health and national securityhave now become merged to create a spectrum of biosecurity issues that encompasses naturally occurring incidents, accidental outbreaks and deliberate use of infectious disease. this intertwining is reflected in both domains: in the public health domain, the who for example had its mandate extended to include responding to deliberate use of biological agents and in the traditional arms control arena, states parties to the biological weapons convention are creating synergistic relations with public health organisations to further their aims of mitigating the effects of a deliberate use should it occur. in addition, the global health security agenda also reflects a change in views regarding responsibility for responding to this spectrum of biosecurity issues: whereas in the security council viewed hiv/aids as posing a threat to a geographically defined area, the sars outbreak in and the potential of an influenza pandemic shortly thereafter illustrated the truly global interconnected nature of the threat and so the shared international responsibility of responding to them. to use an argument put forward by andrew lakoff and stephan collier ( ) , the issue for the future is not whether a disease outbreak can be characterised as a biosecurity threat which requires attention but what kind of biosecurity problem does it present, what kind of techniques are used to assess them and what is the most appropriate kinds of responses. notes . on this see for example central intelligence agency, unclassified report to congress on the acquisition of technology relating to weapons of mass destruction, st july- st december . available at https://www.cia.gov/ library/reports/archived-reports- /july_dec .htm#chemical. . for example: in the uk, the anti-terrorism crime and security act, created a list of "dangerous" pathogens which required additional security requirements and access restrictions. in addition, the secretary of state now had to be informed of any premises where any dangerous substances was kept and used. . in addition to political action, the scientific community also responded to the perceived heightened vulnerability, especially addressing what actions they might take to support national efforts to prepare against deliberate attacks using disease and what actions they needed to take to prevent their work from being deliberately misused and contributing to the development of biological weapons. for more on this see mcleish c ( ) "science and censorship in an age of bioweapons threat" science and culture : , - ; mcleish c and p nightingale ( ) "biosecurity, bioterrorism and the governance of science: the increasing convergence of science and security policy", research policy ( ) - . . for more information on these initiatives see http://www.psi-online.info; http:// www.nti.org/treaties-and-regimes/global-partnership-against-spread-weaponsand-materials-mass-destruction- -plus- -over- -program/ and http://www. ghsi.ca/english/index.asp. . at the time of writing three such intersessional processes have been completed which have focused on topics as diverse as strengthening national implementation of the convention; assistance and cooperation in the events of a biological weapons attack; reviewing relevant developments in science and technology; and awareness efforts amongst scientists. for more information on the biological weapons convention and the intersessional process see www part of the reason for the unprecedented scale of the outbreak was its spread to urban centres including the capital cities of the three worst affected countries foreword' a more secure world: our shared responsibility united nations high level panel on threats challenges and change interrogating bio-insecurities' the global threat of new and re-emerging infectious diseases: reconciling us national security and public health policy review of intelligence on weapons of mass destruction security a new framework for analysis us military global health engagement since / : seeking stability through health the global aids disaster unclassified report to congress on the acquisition of technology relating to weapons of mass destruction sars and new york's chinatown: the politics of risk and blame during an epidemic of fear pandemic security federal agency biodefense funding aids is declared threat to security: white house fears epidemic could destabilize world china in the grip of sars the international response to the outbreak of sars in communicating disease risk: then and now sars scare hurts business in chinatowns international pledging conference on avian and human pandemic influenza the revised international health regulations: a framework for global pandemic response moving forward to the public health response to sars, institute of medicine, forum on microbial threats biosecurity interventions: global health and security in question emerging infections: microbial threats to health in the united states, committee on emerging microbial threats to health, division, institute of medicine avian and pandemic influenza: progress and problems with global health governance science and censorship in an age of bio-weapons threat biosecurity, bioterrorism and the governance of science: the increasing convergence of science and security policy terrorism with chemical and biological weapons: calibrating risks and responses, alexandria, va: chemical and biological arms control institute. national intelligence council ( ) the global infectious disease threat and its implications for the united states grounding a pandemic transmission of the severe acute respiratory syndrome on aircraft assessing the economic impact and costs of flu pandemics originating in asia how popular perceptions of risk from sars are fermenting discrimination hiv/aids, security and ethics ataxia: the chemical and biological terrorism threat and the will terrorists turn to poison? chemical/biological terrorism: coping with a new threat toxic terror: assessing terrorist use of chemical and biological weapons scourge: the once and future threat of smallpox united nations general assembly resolution / ( ) measures to contain and combat the recent ebola outbreak in west africa united nations mission for ebola emergency response un security council holds debate on impact of aids on peace and security in africa on the responsibility of the security council in the maintenance of international peace and security: hiv/aids and international peace-keeping operations united nations security council resolution ( ) peace and security in africa united states department of state ( ) new ways to strengthen the inter-national regime against biological weapons global public health response to natural occurrence, accidental release or deliberate use of biological and chemical agents or radio nuclear material that affect health summary of probable sars cases with onset of illness from pandemic influenza preparedness and response: a who guidance document report of the ebola interim assessment panel world health organization executive board ( ) implementation of the international health regulations originally trained as an historian and philosopher of science, her work focuses on issues relating to governance of dual use technologies and the design of effective mechanisms to prevent misuse of legitimate science and technology key: cord- -hgzneooy authors: david, yadin; judd, thomas title: evidence-based impact by clinical engineers on global patients outcomes date: - - journal: health technol (berl) doi: . /s - - - sha: doc_id: cord_uid: hgzneooy the intersection of technological changes and societal evolution has transformed every aspect of human life. technological advancements are transforming how healthcare knowledge is expanding and accelerating the outreach of critical medical services delivery (jamal et al. in health information management journal ( ): – , ). while this transformation facilitates new opportunities simultaneously it also introduces challenges (jacobzone and oxley, ). appropriate health technology (ht) is vital to new and existing global health care programs. therefore, qualified professionals who can safely guide the development, evaluation, installation, integration, performance assurance, and risk mitigation of ht must be in position to lead. trained clinical engineers (ce) and biomedical engineers (be) have been recognized by the world health organization (who) as the essential practitioners to providing this critically needed guidance. over the past four years, a senior professional group participated in an international project that seeks evidence for the hypothesis - that the engagement of ce and be in guiding ht - impacts positively on patient outcomes, while the alternative is that there is no difference. the group collected published data that was subjected to peer review screening; additional data qualification conditions are described in this paper. the project was initiated at the global ce summit during the first international clinical engineering and health technology management congress (icehtmc) in hangzhou, china in october (global clinical engineering summit at the first international clinical engineering and health technology management congress, ). following the adoption of a resolution to investigate ce contributions to the improvement of world health status, an international survey and literature survey were initiated. during the first two years of this project case studies from countries were identified covering the previous ten years. the results of this survey were presented to health leaders at the world health organization (who) world health assembly in . last year, case studies were added including more countries covering the – period. the combined project contains qualified submissions from countries. the conclusion was that engagement of ce and bme is critical for successful investment in ht and for achieving intended patient outcomes. this paper describes the project’s plan, the results of the literature review performed, and the evidence identified during the process. the intersection of technological changes and social evolution has transformed every aspect of human life [ ] . this transformation is expansive and most obvious in the changes that has been occurring over the past fifty years in the provisioning of healthcare services [ ] . the dependence of health, rehabilitation, and wellness programs on technology for the delivery of services has never been greater [ ] . therefore, it is essential that health technology (ht) be strategically guided and optimally managed [ ] . guidance can only be provided by educated and experienced professionals who can safely lead the full life cycle of the technology, starting with innovation and progressing to development, regulatory compliance, evaluation, installation, training, integration, performance assurance, and risk mitigation. however, these professionals must be familiar with the relationship between contributions from ht and their impact on patient outcomes. the understanding of this relationship is a fundamental requirement for achieving optimal return on investment and improvement of outcomes. such practitioners are critical members of the healthcare team and should be in position to facilitate technology-related plans. beyond the ongoing healthcare burdens of population growth, political and economic instability, disease management, disasters, refugees, accidents, terror attacks, and increasing dependence level on technology, our world of healthcare systems is facing enormous challenges to manage its resources in the twenty-first century. the flood of scientific and technological innovation is radically redefining the nature of healthcare in virtually every dimension, from vascular nanoengineered interventions and predictive diagnostic tests to image guided surgery and remote telehealth-based services at the national and global levels. however, most healthcare systems are not adequately staffed to safely and effectively manage these forces of change. most systems are structured around vertically-expert professions (medical doctors, medical physicists, nurses, administrators), but lack the "horizontal expertise" that trained biomedical and clinical engineers (be&ce) provide. for example, the expertise in assessing and managing the integration and the performance of complex smart systems that have varying areas of service, durations of technological lifecycle [ ] , hardware and software platforms, and middleware in support of integrated medical and surgical services. disproving the myth -that there is a lack of evidence to qualify how much the dependency of ht is well-guided by ce expertise and best practice methodologyled to our examination of published literature and formal presentations of case studies in which ces, bes, and those in similar roles have participated. this allowed us to answer the question whether their participation contributed to improvement in overall healthcare outcomes. in the field of ht management and ce, the incentives to publish studies are lower than it should be, resulting in limited volume of resources to develop best practice measures. despite these perceived limitations, our results were recently published [ ] . in this paper, the focus is on the process used for the selection of data sources and the methodology to qualify their inclusion, described in the methodology section of this paper. on the other hand, over the past years, concerns were expressed that there is a lack of knowledge by government agencies and key stakeholders, coupled with limited recognition for those contributions for the practitioners that guide the deployment, creation and safe deployment of health technology. our data answers these concerns. if the knowledge and the expertise of the global ce community does have a critical role in optimal guidance of ht deployment, how can that expertise be best demonstrated. the collection of the case studies (that were later called success stories) from all over the world can facilitate the determination if there is competency unique to ces around the world that leads the development and optimal management of these technology life cycles. having this knowledge can help to reach better understanding of the required strategy to achieve desired patient outcomes when technology is used in care and rehabilitation management. the ebola virus disease crisis [ ] has demonstrated that multidisciplinary team expertise and collaboration are keys to success. low resources countries in particular face a challenge of improving their health services because, in addition to the above stated challenges, they also have scarce availability of professional expertise trained to address technology-related issues [ ] . varied availability and state of infrastructure and human resources place higher demand on adequate management of ht innovation and deployment. the effective health workforce of the twenty-first century consists of more individual practitioners caring for complex health-issues and thus charged with deploying the most optimal benefits from medical technology, such as proper selection, effectiveness, timely access, and affordable. in academia, government, and industry, teams of be&ce translate design innovations and integrate knowledge of science, engineering, standards and regulations with clinical strategy to create new tools that save and improve lives while building more quality into patient outcomes. in hospitals, be&ce practitioners ensure that proper acquisition, installation, integration and operation of devices and systems are safe and efficient. with the increasing role of technology in the delivery health care services, professional competency of the entire span of the technology lifecycleacross systems and sectorsis critical to achieving the full benefits and best outcomes clinically, economically, and operationally. following the resolution adopted at the first international clinical engineering and health technology management congress [ ] that took place in hangzhou, china, in october , senior members from the ce profession from around the world who participated in the global ce summit [ ] initiated the international project seeking evidence to the hypothesis that the engagement of ce and be in guiding ht deployment positively impacts patient outcomes while the null hypothesis was that there is no difference. the group identified the volume of published data that and developed criteria for inclusion pertinent and qualified publications. the rules are shown in fig. below. several conditions were placed on the total volume of publications and formal presentations that were found. only sources that responded positive to the challenge of the criteria were included in the final examination. to begin with, the source must be subjected to peer-review screening. secondly, the source must include care-related outcomes in the body of the manuscript, thirdly the source had to be published in ifmbe [ ] sponsored publication or event (meeting) proceedings, fourthly, the source must describe how ce or bme practices led to the second criterion of outcomes, and the fifth criterion limit the source inclusion to specific window of time. this window was defined as - for the first phase of this examination, and - for the second phase. during the first two years of the project case studies from countries were identified and satisfied the criteria described in fig. . searching through the time span over a period of previous ten years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the results of the initial review were presented to health leaders from member countries at the who world health assembly in . the interest generated in the project helped to sustain its work and as a result of the continuation of data analysis the team identified and qualified additional case studies from a total of countries covering the period of the - . the combined project's two stages examine and qualified over qualified submissions from countries. next, we looked at the methodology of putting together peer recognized clinical engineering experts from around the world, all members of the ifmbe clinical engineering division and issued a call for collections of papers from around the world, that will demonstrate what is the involvement and what is the contribution of individual programs from around the world in the ce arena. within months, in , we were able to collect a vast volume of evidence that was qualified and filter into specific studies from countries. the literature sources and the results of the examination are presented, grouped into six categories of outcomes impact. the resulting qualified volume of sources were categories into groups. the six groups were created to facilitate decision if sufficient evidence has been accumulated to support conclusion of outcomes. while the six categories were reviewed independently the significant overall commonality is that they all address different aspects of ht technology's impact on outcomes. data collected that met the inclusion criteria was grouped into six categories as follows: through provision of new ht solutions, adaptation of existing, or a combination to address several issues. ease in reaching ht-related health services or facilities in terms of location, time, and ease of approach. positive impact from more efficient and effective deployment of ht at national or policy level. ht's positive impact on health services safety or quality outcomes, or through ht human resource development. establishing or improving htm methodology resulting in improved population health or wellness. improvements achieved due to deployment of internet-based ht tools.following phases of the technology life cycle the analysis of the data began with the group that starts the cycle -with the innovation phase. innovation and the provision of new solutions to existing problems. the next group, reasonable progression to health services. where the question to address was the possible existence of evidence to demonstrate that the access to health care services has increased because of technology management programs. or, did the ht management program established methodologies that improve the overall finance and/or wellness of the population. after that, review of data was conducted with regard to overall impact on national or regional systems or multi-hospital health systems. safety and quality services that dependent on complex technological systems is critical for outcomes and therefore identified with its own group of data technology management group was the next category to be reviewed where ce/bme contributions to organized, integrate, manage, and improve safe and efficient sustainable ht. finally, in a way of looking forward the future, the group of e-technology where telemedicine, image guided interventions, informatics and disaster response operation were grouped together. making assumption that with the introduction of complex technological systems improvements in patient care safety and the quality of services receive were evident. with review of data in these six categories this study was able to cover major activities that are technology-dependent in health. successful source (or submission) was defined as satisfying objective measures developed by the investigators: timeliness, cost saving, deployment or adoption by care providers, impact on services, and overall projection for success. each success metric was evaluated using -point scale against a statement representing the success construct ( = strongly disagree; = strongly agree). timeliness refers to whether the project/submission was implemented in timely manner. this was measure by the statement "the submission will impact outcomes on present time." the cost measure was evaluated on whether the submission's overall costs were within budget constraints and reasonable for the conditions in the region. this was assessed by the statement, "the submission cost objectives can be met in the region." the final two metrics were combined into the statements "the submission will be deployed by its intended users" and "the submission will have a positive impact on those who will adopt it." finally, overall submission success was assessed with the statement "all things considered, the submission will be a success." success was determined when the source received overall rating of or above. sources for data collection included the following: ifmbe/ clinical engineering division (ced) health technologies resources [ ] document provided to the world health assembly, who in may , the nd and rd global forums on medical devices [ ] organized by the world health organization ifmbe/ ced's china and brazil icehtmc [ ] october and september respectively, others [ ] ifmbe journals proceedings and published sources from the period - . the results containing criteria inclusive and qualified data were tabulated and categorized into six categories that are described in tables below. the tables provide detailed information about the category of the submission, the region summitted it, the submission title and authors identification. each of submission is accompanied by hot link facilitating further data and evidence details that the reader is welcome to pursue. the data in these tables with the accompanied links demonstrates that evidence exists for benefit registered in each of the six categories from every region around the world. overall this review identified evidence from case studies received from countries where management of medical devices (as main component of health technologies) made a positive difference over the past twelve years. the results of first phase of the literature survey were incorporated into a document that in may of was successfully presented to the world health assembly consisting of member country delegations of ministry of health from around the world to who in geneva switzerland [ ] . data collection and analysis was conducted over three years period employing the same selection factors as shown in fig. . the analysis shows that volume of evidence exists in the literature to demonstrate the important and critical contributions of ce and bme to the initiation of new and improvement of present care outcomes. these contributions are evident on every continent and every day of the year. not just randomly but continuously x x days. after the completion of the two phases of this literature survey publications from countries document evidence and showing the success of clinical engineering competency serving on the healthcare delivery team (tables , , , , and ). the case studies are actually ht success stories demonstrating, in a limited resource environment, that it is desirable to include professional ht expertise, such as clinical engineers, in national decision-making in order to maximize health systems' services. case studies from the links on the following pages demonstrate these benefits: & access: the ministry of health ht unit-led project in albania that doubled access to critical diagnostic services, such as computed tomography scanners, magnetic resonance and angiography imaging, while reducing equipment downtime to zero, and significantly reducing cost. & health systems: improved coordination between multiple stakeholders in the national laboratory and its satellites in colombia, led by the ministry of health and clinical engineers who partner with experts from academia and industry. & quality & safety: a clinical engineer-led -hospital program in the shanghai region that cooperates with officials, industry, and academic entities, resulting in improved device user satisfaction, tracking of emerging technologies, and closer partnerships with industry. & table innovation & table access & table management & table health systems & table e-technology & table quality & safety in all of the above mentioned topics, data collection, review and validation continued throughout the project period as access to ifmbe sponsored events and related publications was secured in phases. during and we added more evidence that was qualified by our criteria. additional stories from additional of countries, were now increasing the overall count to publications from countries. all with evidence, showing the success from ce involvement in the relationship to improving patient outcomes, and the derived benefits from ht creation, management, and deployment. involvement that is documented through services provided over days a year, h a day, days a week. to be included in the project evidence database, shown in the tables above, each entry must comply with conditions for inclusion and with performance parameters described earlier of timeliness, costsaving, extent of deployment or adoption by care providers, impact on overall services and estimated projection for the entry success. the timeliness parameter complied if an impact has been described in the entry as immediate as in present tense. other parameters were similarly considered similarly. all entries included can be viewed through the on-line links provided in the tables. the hot links to all the resources the task force reviewed and qualified were validated. the tables are color coded to facilitate ease readers interest of seeking additional details for a specific technology category. examples of entries from the table above describe details as follow: in the innovation category, for example, anne-louise smith from adelaide, australia, with a team of clinicians identified a need for solution to specific clinical problem related to retrieval to transfusion of fluids of patients who maybe in a shock. no device was able to meet the need of fulfilling the task without external power source. the entry -bme development of non-electric portable blood/fluid warmer for roadside trauma, describe the critical contribution of ce to create solution, test it, identify and resolve usability barriers and bring it to commercialization. transferring of patients in rural areas is now safer and having better patient outcomes. the engineering expertise and the collaboration with physicians were key factors for the success evident in this entry. in the health systems category: bilal beceren, from turkey, affiliated with ministry of health (moh) of turkey practices at the national ht management program, involved public hospitals. prior to there was no moh based program and knowledge of the medical technology assets deployed. they embarked on national project in that built information about medical assets purchasing, commissioning and facilitated better performance support. ce training was initiated, and maintenance support has increased. the outcomes show that medical technology has been acquired under better terms, more efficiently maintained, the uptime of % for covered inventory now was reachable facilitating better patient care. annual audits conducted since show that from unknown level prior to the program in reached coverage of % of the inventory in the country. national health technology management system for public hospitals in turkey improve the performance and cost efficiency of the technology that patient management is dependent upon. in the access category: ledina picari from the moh in albania, a clinical engineer by training identified concern about the access to diagnostic services. diagnostic imaging technology was not properly maintained and equipment up time did not meet patients' need. in a collaborative national project was initiated to examine the state of equipment management and identify opportunities for increasing access to diagnostic services, to increase clinical availability of diagnostic technology at the local level, and to increase efficient and effective use of public funds. the evidence provided shows that in the volume of ct examinations more than doubled from to exams while the equipment downtime was reduced from almost four months a year down to near days. this is important achievement that in addition delivered the benefit of reducing the maintenance costs from about to % before the project was initiated down to % of the purchase price per annum afterwards. diagnostic technology availability significantly improves patient's outcome. a second example in the access to health services category that bridges to e-technology and specifically a telemedicine program was initiated with ce guidance (yadin david) in houston, texas. the project aimed at connecting rural community in central america village in the safety and quality category, li bin, a ce from shanghai, china, identified the need for having better technology quality control as there was not clear measure in the management of the technology in large network of care providers before . network of care providers facilities in community of million population, hospitals above grade two, and about ce & bme in the region. as result of this project in they changed the conditions from lack of quality standards in purchasing and servicing of diagnostic technology they implemented enhanced management program with collaboration of industry. data sharing and benchmarking information led to better cooperation between the parties, improve service personnel training, the initiation of annual quality improvement reporting and to sustain readiness of technology to serve clinical objectives. they now know that there are billion yuan of medical equipment assets, this is about billion dollars usd that due to ce management improved outcomes for both financial investment in technology and clinical services to patients. the e-technology category has another example of how be & ce contributed to better outcomes, specifically during the devastating earthquake in port-au-prince, haiti. in that occasion, article of new england journal of medicine, march , describes how support staff, including ce, arrived at haiti and within two days after the earthquake, established a field hospital that was able to treat patients, performed surgeries, and delivered babies. the first baby born there was named by his mother 'israel'after the group origin that came to establish the field hospital there. finally, in the ht management category, in brazilian rainforest, we found another evidence for how ce expertise has helped to achieve better patient outcomes and improving care. ryan pinto ferreira from university of campinas, optimal transportation method and assembly all the medical devices that clinicians needed. they transport it over the challenge of difficult route, to be placed in a highly humid rainforest environment. they assembled, commissioned, and operated the equipment and provided support for clinical services that those patients needed. at the who, in the health systems category, adriana velasquez have implemented many technology-based patient care programs that have far reach all over the world. her collaborative efforts perhaps best known through assembling networking of international stake holders during the successful series of global forums on medical devices. another successful contribution she achieved has been the development and dissemination of international publication and resources [ ] for addressing ht issues such as creating a resource for global atlas of medical devices, global model for regulatory framework, medical device policies, compendium of new and emerging health technologies, human resources ht is vital to health and the dependence of health, rehabilitation, and wellness programs that rely on ht for the delivery of their services has never been greater. beyond the ongoing healthcare burdens of population growth, political and economic instability, disease management, disasters, the refugee crisis, accidents, and terror attacks, world healthcare technological systems are facing enormous challenges to be innovative and optimally managed. the transition into health programs for the st century requires the employment of trained competent ce professionals. disease prevention, treatment, and rehabilitation is more efficient and effective when health services are provided with appropriate tools. along with world health organization (who) [ ] , the international it is critical, therefore, that with limited availability of resources, ht must be professionally managed and its creation and deployment over its life-cycle be appropriately guided. this paper describes the extensive study of published data on the vast contributions by ce that positively impact patient outcomes. this finding of this study shows that every region of the world including lowresource regions face a challenge of improving health services while facing varied levels of infrastructure and human resources capacity challenges. ces play vital roles in all stages of healthcare technology life-cycle management. from creation to planning, and from commissioning to utilization and integration; technology-based systems must and can be managed for optimal performance. in each of the technology life-cycle stages the requirement for trained and competent ce input makes critical difference as evidence show in the analyzed data reviewed above. it is our hope that government agencies and other interested parties will have better understanding of ces role and thus will support their inclusion in the healthcare team of professionals. the identified and qualified case studies shown in this manuscript support the need to expand the reach of ce community in order to provide competent guide to management of healthcare technologies around the world. case studiesgrouped in categoriescan assist to formulate national strategies and plans on how to improve the creation and deployment of ht while improving quality of care and efficient use of scares funding. in several countries, case studies demonstrated, this has best been achieved by developing a ht unit at the level of ministry of health that engages the ce community. these studies provide evidence that ht is beneficial; however, at times, deployment of such complex systems when it is not effectively guided and managed may not realize intended outcomes for optimal impact. the who wha resolution . urges member states to create national ht management plans in collaboration with clinical and biomedical engineers. who further clarified the definition of these personnel in - as part of a global survey [ ] in coordination with ifmbe/ced. "trained and qualified biomedical engineering professionals are required to design, evaluate, regulate, maintain and manage medical devices, and train on their safe use in health systems around the world. " these occupations have various names in different countries like clinical engineers, medical engineers, … and related professionals and technicians." we encourage the dissemination of survey tools as describe here to better understand the need for and monitoring of progress towards safe, appropriate and optimal quality care outcomes. the authors express gratitude for the intense work invested by members of the project task force and for kallirroi stavrianou for creating and validating all of evidence links on the tables above. conflict of interest the authors declare that they have no conflict of interest. ethical approval this article does not contain any studies with human participants or animals performed by any of the authors. informed consent informed consent was not obtained since there were individual participants included in the study. using technology to advance global health, proceedings of a workshop, forum on public-private partnerships for global health and safety a 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system for identification of patients in healthcare design of a web-based medical equipment management system for clinical engineering technological surveillance and integrity monitoring of infusion systems implementation of six sigma on corrective maintenance case study at the directorate of biomedical engineering in the jordanian ministry of health human resources for medical devices, the role of biomedical engineers, who, medical devices the impact of health information technology on the quality of medical and health care: a systematic review healthcare expenditure a future in question + & f o r m = e d g h p t & q s = h s & c v i d = & r e f i g = dd b a c f cf &cc=us&setlang=en-us&plvar= &pc=dcts publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- - xf luzi authors: zheng, ya-li; ding, xiao-rong; poon, carmen chung yan; lo, benny ping lai; zhang, heye; zhou, xiao-lin; yang, guang-zhong; zhao, ni; zhang, yuan-ting * title: unobtrusive sensing and wearable devices for health informatics date: - - journal: ieee trans biomed eng doi: . /tbme. . sha: doc_id: cord_uid: xf luzi the aging population, prevalence of chronic diseases, and outbreaks of infectious diseases are some of the major challenges of our present-day society. to address these unmet healthcare needs, especially for the early prediction and treatment of major diseases, health informatics, which deals with the acquisition, transmission, processing, storage, retrieval, and use of health information, has emerged as an active area of interdisciplinary research. in particular, acquisition of health-related information by unobtrusive sensing and wearable technologies is considered as a cornerstone in health informatics. sensors can be weaved or integrated into clothing, accessories, and the living environment, such that health information can be acquired seamlessly and pervasively in daily living. sensors can even be designed as stick-on electronic tattoos or directly printed onto human skin to enable long-term health monitoring. this paper aims to provide an overview of four emerging unobtrusive and wearable technologies, which are essential to the realization of pervasive health information acquisition, including: ) unobtrusive sensing methods, ) smart textile technology, ) flexible-stretchable-printable electronics, and ) sensor fusion, and then to identify some future directions of research. g lobal healthcare systems are struggling with aging population, prevalence of chronic diseases, and the accompanying rising costs [ ] . in response to these challenges, researchers have been actively seeking for innovative solutions and new technologies that could improve the quality of patient care meanwhile reduce the cost of care through early detection/intervention and more effective disease/patient management. it is envisaged that the future healthcare system should be preventive, predictive, preemptive, personalized, pervasive, participatory, patient-centered, and precise, i.e., p-health system. health informatics, which is an emerging interdisciplinary area to advance p-health, mainly deals with the acquisition, transmission, processing, storage, retrieval, and use of different types of health and biomedical information [ ] . the two main acquisition technologies of health information are sensing and imaging. this paper focuses only on sensing technologies and reviews the latest developments in unobtrusive sensing and wearable devices for continuous health monitoring. looking back in history, it is not surprised to notice that innovation in this area is closely coupled with the advancements in electronics. using electrocardiogram (ecg) device as an example, fig. illustrates the evolution of sensing technologies, where the core technologies of these devices have evolved from water buckets and bulky vacuum tubes, bench-top, and portable devices with discrete transistors, to the recent clothing and small gadgets based wearable devices with integrated circuits [ ] . in the future, it may evolve into flexible and stretchable wearable devices with carbon nanotube (cnt)/graphene/organic electronics [ ] . there is a clear trend that the devices are getting smaller, lighter, and less obtrusive and more comfortable to wear. although physiological measurement devices have been widely used in clinical settings for many years, some unique features of unobtrusive and wearable devices due to the recent advances in sensing, networking and data fusion have transformed the way that they were used in. first, with their wireless connectivity together with the widely available internet infrastructure, the devices can provide real-time information and facilitate timely remote intervention to acute events such as stroke, epilepsy and heart attack, particularly in rural or otherwise underserved areas where expert treatment may be unavailable. in addition, for healthy population, unobtrusive and wearable monitoring can provide detailed information regarding their health and fitness, e.g., via mobile phone or flexible displays, such that they can closely track their wellbeing, which will not only promote active and healthy lifestyle, but also allow the objectives of this paper are to provide an overview of unobtrusive sensing and wearable systems with particular focus on emerging technologies, and also to identify the major challenges related to this area of research. the rest of this paper is organised as follows: section ii will discuss unobtrusive sensing methods and systems. section iii will present the recent advances and core technologies of wearable devices and will also highlight the latest developments in smart textile technology and flexible-stretchable electronics. section iv will discuss data fusion methods for sensing informatics as well as the impacts of big data in healthcare. section v will conclude the paper with promising directions for future research. the main objective of unobtrusive sensing is to enable continuous monitoring of physical activities and behaviors, as well as physiological and biochemical parameters during the daily life of the subject. the most commonly measured vital signs include: ecg, ballistocardiogram (bcg), heart rate, blood pressure (bp), blood oxygen saturation (spo ), core/surface body temperature, posture, and physical activities. a conceptual model of unobtrusive physiological monitoring in a home setting is shown in fig. [ ] . unobtrusive sensing can be implemented in two ways: ) sensors are worn by the subject, e.g., in the form of shoes, eyeglasses, ear-ring, clothing, gloves and watch, or ) sensors are embedded into the ambient environment or as smart objects interacting with the subjects, e.g., a chair [ ] , [ ] , car seat [ ] , mattress [ ] , mirror [ ] , steering wheel [ ] , mouse [ ] , toilet seat [ ] , and bathroom scale [ ] . fig. shows some prototypes of the unobtrusive sensing systems developed by different research groups. information can be collected by a smartphone and transmitted wirelessly to a remote center for storage and analysis. in the following section, we will discuss some unobtrusive sensing methods for the acquisition of vital signs. capacitance-coupled sensing method is commonly used for measuring biopotentials such as ecg, electroencephalogram (eeg) and electromyogram (emg) [ ] , [ ] . for this method, the skin and the electrode form the two layers of a capacitor. without direct contact with the body, some issues, such as skin infection and signal deterioration, brought about by adhesive electrodes in long term monitoring can be avoided. some typical implementations of capacitive ecg sensing are summarized in table i . in addition, capacitive sensing can also be used for other applications such as respiratory measurement, e.g., using a capacitive textile force sensor weaved into clothing [ ] , or a capacitive electrical field sensor array placed under a sleeping mattress [ ] . the major challenges in designing these noncontact electrodes lie in the high contact impedance due to the indirect contact and the capacitive mismatch caused by motion artifacts [ ] . it may cause low signal to noise ratio and thus lead to challenges in the frontend analog circuit design. the input impedance of the amplifier has to be extremely large (> tΩ) to reduce the shunt effect formed by the capacitor and the input impedance. moreover, motion artifacts may become more significant in noncontact sensing. some methods have recently been proposed to over- . unobtrusive sensing devices with sensors embedded in daily objects, such as mirror [ ] , sleeping bed [ ] , chair [ ] , steering wheel [ ] , and toilet seat [ ] . come these problems to achieve robust measurement in practical situations. for instance, the gradiometric measurement technique introduced by pang et al. can considerably reduce motion artifacts [ ] . photoplethysmographic (ppg) sensing, which involves a light source to emit light into tissue and a photo-detector to collect light reflected from or transmitted through the tissue, has been widely used for the measurement of many vital signs, such as spo , heart rate, respiration rate, and bp. the signal measured by this method represents the pulsatile blood volume changes of peripheral microvasculature induced by pressure pulse within each cardiac cycle. traditionally, the sensing unit is in direct contact with skin. recent research has shown that sensors can be integrated into daily living accessories or gadgets like ear-ring, glove and hat, to achieve unobtrusive measurement. various table ii. recently, jae et al. [ ] proposed an indirect-contact sensor for ppg measurement over clothing. a control circuit was adopted to adaptively adjust the light intensity for various types of clothings. on the other hand, poh et al. [ ] showed that heart rate and respiration rate can be derived from ppg that was remotely captured from a subject's face using a simple digital camera. however, the temporal resolution of the blood volume detected by this method is restricted by the sample rate of the camera (up to frames per second), thus affecting its accuracy. sphygmomanometer, which has been used over a century for bp measurement, is operated based on an inflatable cuff. conventional methods such as auscultatory, oscillometric, and volume clamp are not suitable for unobtrusive bp measurement. pulse wave propagation method is a promising technique for unobtrusive bp measurement. it is based on the relationship between pulse wave velocity (pwv) and arterial pressure according to moens-korteweg equation. pulse transit time (ptt), the reciprocal of pwv can be readily derived from ppg and ecg in an unobtrusive way. various linear and nonlinear models that expressed bp in terms of ptt have been developed for cuffless bp estimation. the subject-dependent parameters in bp-ptt model should be determined first when using this approach for bp estimation. a very simple way to implement individual calibration is to use the hydrostatic pressure approach, where the subjects are required to elevate their hands to specific heights above/below the heart level [ ] . a theoretical relationship between ptt, bp, and height can be written in ( ) , as shown at the bottom of the page, where b is the subjectdependent parameter characterizing the artery properties, l is the distance traveled by the pulse, p h is the hydrostatic pressure ρgh, and p i is the internal pressure. using the proposed model, the individualized parameters in bp-ptt model can be determined from some simple movements. this model-based cuffless bp measurement method can be implemented in a variety of platforms for unobtrusive monitoring, such as the bed cushion and chair, as shown in fig. . although the accuracy of this method has been validated in many recent studies [ ] , there are concerns over the use of ptt as a surrogate measurement of bp. it has been recognized that the major confounding factors in the present relationship of bp and ptt are vasomotor tone and pre-ejection period [ ] . new models should be developed to include these confounding factors in order to explore the potential of ptt-based method for unobtrusive bp measurement in future. strain sensors are commonly used to measure body motion such as respiration, heart sound and bcg. piezoelectric cable sensor, whose sensing element is piezoelectric polymer, has been used for respiration rate monitoring [ ] . flexible and thin sensors, such as piezoresistive fabric sensors [ ] and film-type sensors like polyvinylidenefluoride film (pvdf) and electromechanical film (emfi) based sensors [ ] have been widely used for cardiopulmonary applications due to the easiness of being embedded into clothing or daily objects like chair or bed. comparative study has been conducted to evaluate the performances of the two different strain sensors in the measurement of body motion [ ] . they have shown that only small differences were found in heart rate measured by pvdf-based and emfi-based sensors especially at supine posture, which was possibly caused by their different sensitivities to different force components. inductive/impedance plethysmography is another widely used method for respiratory measurement and has been developed in the forms of clothing and textile belt [ ] , [ ] . two sinusoid wire coils located at rib cage and the abdomen are driven by a current source that generates high-frequency sinusoidal current. the movement of the chest during respiration causes changes of the inductance of the coils and thus modulates the amplitude of the sinusoidal current, from which the respiratory signal can be demodulated. a recent study compared the performances of four different methods for wearable respiration measurement, including inductive plethysmography, impedance plethysmography, piezoresistive pneumography, and piezoelectric pneumography piezoelectric, and showed that piezoelectric pneumography provided the best robustness to motion artifacts for respiratory rate measurement [ ] . optical fibers have also been adopted for unobtrusive monitoring by embedding them into daily objects or clothes. in contrast to electronic sensors, they are immune to the electromagnetic interference. recently, fiber bragg grating has been proposed as a vibration sensor for bcg measurement, based on the fact that the bragg wavelength is correlated with the grating period in response to the body vibration caused by breathing and cardiac contractions [ ] . a pneumatic cushion based on this method has been developed to monitor the physiological conditions of pilots and drivers [ ] . d'angelo developed an optical fiber sensor embedded into a shirt for respiratory motion detection [ ] . other remote sensing methods have also been proposed for unobtrusive physiological measurement, such as frequency modulated continuous wave doppler radar for bcg measurement [ ] and radiometric sensing for body temperature measurement [ ] . in this section, an overview on the state-of-the-art of wearable systems is presented. several key enabling technologies for the development of these wearable devices, such as miniaturization, intelligence, networking, digitalization and standardization, security, unobtrusiveness, personalization, energy efficiency, and robustness will be discussed. sensor embodiments based on textile sensing, flexible and stretchable electronics are also introduced. a variety of unobtrusive wearable devices have been developed by different research teams as shown in fig. : the watchtype bp device [ ] , clip-free eyeglasses-based device for heart rate and ptt measurement [ ] , shoe-mounted system for the assessment of foot and ankle dynamics [ ] , ecg necklace for long-term cardiac activity monitoring [ ] , h-shirt for heart rate and bp measurement [ ] , an ear-worn activity and gait monitoring device [ ] , glove-based photonic textiles as wearable pulse oximeter [ ] , a strain sensor assembled on stocking for motion monitoring [ ] , and a ring-type device for heart rate and temperature measurement [ ] . these embodiments are capable of providing measurements ubiquitously and unobtrusively. many of them already have a variety of applications in healthcare as well as wellness and fitness training. for example, posture and activity monitoring of the elderly and the disabled, longterm monitoring of patients with chronic diseases like epilepsy, cardiopulmonary diseases, and neurological rehabilitation. implantable sensors: it is worth noting that sensing devices should not be limited to those designed to be worn on the body. there are increasing numbers and varieties of implantable sen- fig. . unobtrusive wearable devices for various physiological measurement developed by different groups: watch-type bp device [ ] , ppg sensors mounted on eyeglasses [ ] , motion assessment with sensors mounted on shoes [ ] , wireless ecg necklace for ambulatory cardiac monitoring (courtesy of imec, netherlands) [ ] , h-shirt for bp and cardiac measurements [ ] , ear-worn activity recognition sensor [ ] , glove-type pulse oximeter [ ] , strain sensors mounted on stocking for motion monitoring [ ] , and ring-type device for pulse rate and spo measurement [ ] . sors have been introduced, which are designed to be implanted inside the human body. for example, cardiomems recently developed a wireless implantable haemodynamic monitoring system, which can provide long-term measurement of pulmonary arterial pressure of patients with heart failure [ ] . a recent clinical study was conducted to validate the safety and effectiveness of this device, and the results showed that the heart-failurerelated hospitalization can be significantly reduced in the group with the implant compared to the control group [ ] . another example is the wireless capsule device that can be pinned on the esophageal to measure ph level over a -hour period for better diagnosis of gastroesophageal reflux disease [ ] . however, the sensor is difficult to be securely attached for the complete sensing periods in some subjects, and premature losing of the capsule has been reported quite often. other technologies such as the development of mucosal adhesive patches could be a potential solution in this regard. another important application for mucosal adhesive patches is to design them as drug delivery systems. by placing these devices inside the gastrointestinal tract and with feedback mechanisms installed, the release of drug can be better controlled. this is anticipated to be helpful to the better management of many chronic diseases, such as diabetes and hypertension. in addition to unobtrusive sensing methods mentioned in the last section, some key technologies should also be developed to implement unobtrusive wearable devices for practical use. zhang's research group summarized these key technologies as "minds" (miniaturization, intelligence, networking, digitalization, standardization) [ ] . the recent development of these technologies will be elaborated as follows together with some other important issues such as unobtrusiveness, security, energyefficiency, robustness, and personalization. ) miniaturization and unobtrusiveness can enhance the comfortness of using wearable devices, and thus increasing the compliance for long-term and continuous monitoring. thanks to the rapid development of integrated circuit technologies and microelectromechanical technologies, the size of processing electronics and inertial measurement units (imus) has been significantly reduced for wearable applications. for instance, brigante et al. recently developed a highly compact and lightweight wearable system for motion caption by careful selection of imus and optimized layout design [ ] . a highly integrated microsystem was designed for cardiac electrical and mechanical activity monitoring, which assembled the multisensor module, signal processing electronics, and powering unit into a single platform with a flexible substrate [ ] . in addition to the integrated design and compact packaging, the development of new measuring principle is another way to achieve miniaturization. the aforementioned ptt-based cuffless bp measuring method is a promising substitute for the widely used cuff-based methods in this regard. further miniaturization can be achieved by using other technologies such as inductive powering where the sensor can be powered partly or completely by rf powering, and the battery can be removed [ ] . as mentioned, capacitive coupling sensing is one commonly used method for unobtrusive capturing of bioelectrical signals, like ecg and eeg. textile sensing is another unobtrusive method for continuously monitoring physiological parameters. a textile-integrated active electrode was presented in [ ] for wearable ecg monitoring, which could maintain signal integrity after a five-cycle washing test. in addition, ppg offers a good way for unobtrusive cardiovascular assessment, such as noninvasive measurement of bp based on ptt. ) networking and security: networking is an integral part of wearable devices to deliver high-efficiency and high-quality healthcare services from the m-health perspective [ ] . the term "bsn"-body sensor network-was coined to harness several allied technologies that underpin the development of pervasive sensing for healthcare, wellbeing, sports, and other applications that require "ubiquitous" and "pervasive" monitoring of physical, physiological, and biochemical parameters in any environment and without activity restriction and behavior modification. bsn can be wired (e.g., interconnect with smart fabric) or wireless (making use of common wireless sensor networks and standards, e.g., ban, wpan (ieee . . ), bluetooth/bluetooth low energy (ble or bluetooth smart), and zigbee). bsn is presently a very popular research topic and extensive progresses have been made in the past decades. related to networking, technical challenges include user mobility, network security, multiple sensor fusion, optimization of the network topology, and communication protocols for energy-efficient transmission [ ] . in a broader sense, networking for sensing can also include wireless personal area network (wpan), wireless local area net-work (wlan) and cellular networks ( g/ g network, gprs, gsm) or wireless wide area network (wwan), which are used to send all the acquired data from wearable devices to data servers for storage and postprocessing. the most critical issue in wpan/wlan technologies is to guarantee the quality of service (qos), which contains latency, transmission power, reliability (i.e., error control) and bandwidth reservation. while for healthcare applications, these issues become more challenging because all the specifications should be satisfied simultaneously. for example, monitoring ecg requires a data rate of tens to hundreds of kilobit/s, end-to-end delay within s and bit error rate of below − [ ] . under some life-critical situations, the compromise between reliability and latency constraint of data transmission is even more prominent. effective error control schemes have been proposed to address this issue, such as the combined use of feed-forward error control (fec) and block interleaving in data-link layer [ ] . for bandwidth demanding applications, such as two-dimensional ( -d) mode of echocardiograph and ultrasound video transmission, to transmit the data with minimal loss of diagnostic information and in real time, the protocol should be designed to optimize the transmission rate, minimize the latency and maximize the reliability. various enhanced protocols on rate control have been proposed for these applications, such as a hybrid solution either using retransmission or retransmission combined with fec techniques depending on the channel conditions [ ] , adapting the sending rate of source encoder according to the mobile link throughput [ ] . security is a critical issue of networking, especially for medical applications. without adequate security, the transmitted information is vulnerable to potential threats, such as eavesdropping, tampering, denial of service, which are caused by unauthorized access. the challenging issues to guarantee security lie in three aspects: how to prevent the disclosure of patient's data, who have the right to access the system, and how to protect the privacy of the user [ ] . securing the data transmission between wearable sensors should be the first step. to secure inter-sensor communications, the most important issue is to design a key agreement for encryption. identity-based symmetric cryptography and asymmetric key cryptography based on elliptic curve have been adopted for bsn [ ] , [ ] . another novel method is based on biometrics traits. since the human body contains its own transmission system such as blood circulation system, it is believed that the information from the system itself can be used to secure the information communication between sensors. meanwhile, since wearable sensors are already there to capture physiological signals, it is convenient to implement encryption schemes using physiological signals in the key agreement. poon et al. firstly proposed to use the interpulse intervals (ipis) as the biometric traits to encrypt the symmetric key, as shown in fig. [ ] . the results showed that a minimum half total error rate of . % was achieved when the signals were sampled at hz and then coded into -bit binary sequences. subsequently, other similar approaches have been proposed [ ] . for example, venkatasubramanian et al. proposed using frequency domain features of ppg as the basis of key agreement [ ] . furthermore, the complexity of the security scheme should also be considered due to the constraints on the energy budget and computational power of the wearable sensor. various potential solutions have been developed, such as the data confidential and user authentication schemes with low complexity realized by minimizing the shared keys [ ] , and mutual authentication and access control scheme based on elliptic curve cryptography with the advantage of energy-efficient [ ] . ) energy-efficiency and digitalization: energy-efficiency is a crucial element of a wearable device that directly affects the design and usability of the device, especially for long-term monitoring applications. there are mainly three strategies to achieve energy-efficient design. the first one is to improve the energy efficiency of the existing energy storage technologies, lithiumion batteries and supercapacitors. liu et al. designed a novel structure of znco o -urchins-on-carbon-fibers matrix to fabricate energy storage device that exhibits a reversible lithium storage capacity of mah/g even after cycles [ ] . fu et al. first adopted commercial pen ink as an active material for supercapacitors. with simple fabrication, the flexible fiber supercapacitors can achieve areal capacitance of . - . mf cm − and power density of up to . mw cm − [ ] . the second is energy-aware design of wearable system. for example, a high-sensitivity near-infrared photo-transistor was recently developed based on an organic bulk heterojunction as shown in fig. (a) [ ] . the results showed that the responsivity of this device can achieve a w − . it has been successfully used for ppg measurement as shown in fig. (b) [ ] . with the high responsivity, this device allows the use of a low-power light source, and thus reducing the power consumption of the sensor. power management approaches, such as dynamic voltage scaling, battery energy optimal techniques and system energy management techniques have also been proposed [ ] . last but not the least is to scavenge energy from the environment or human activities, such as the lower-limb motion and vibration, body heat and respiration, which have great potential to become sustainable power sources for wearable sensors. the mit media lab [ ] has realized an unobtrusive device that scavenged energy from heel-strike of the user with shoe-mounted piezoelectric transducer. recently, leonov [ ] has developed a hidden thermoelectric energy harvester of human body heat. it was integrated into clothing as a reliable powering source. for implantable devices, the preferred power solution is wireless powering. kim et al. have derived the theoretical bound of wireless energy transmit efficiency through tissue. by optimizing the source density, the peak efficiency can achieve × − at around . ghz, which is times larger than that of the conventional near-field coil-based designs [ ] . digitalization is necessary to enable data analysis and storage after acquiring the analog signals from the body with wearable devices. due to the rigorous power constraints of wearable devices, the sampling rate should be minimized to save power whilst not compromising the diagnostic accuracy. for example, the sampling rate for ecg should be no less than hz; otherwise, it will affect the accuracy of measurements [ ] . recently, novel nonuniformly sampling methods have been investigated to compress the representation of ecg signal in which the relevant information is localized in small intervals. one example is the integrate-and-fire sampler that integrates the input signal against an averaging function and the result is compared to a positive or negative threshold as shown in ( ), a pulse will be generated when either of the thresholds is reached. the original signal thus can be represented by a nonuniformly spaced pulse train from the output of the integrate and fire model [ ] . this sampler can be implemented by effective hardware to save power and facilitate sensor miniaturization. however, the tradeoff is that exact reconstruction of the original signal is impossible [ ] . nonetheless, some critical information for accurate diagnosis can be preserved. without reconstruction, a time-based integrate and fire encoding scheme can achieve . % classification rate between normal heartbeats and arrhythmias, which is comparable to other methods [ ] . standardization is a crucial component of any commercial exploitation of wearable devices, as it ensures the quality of the devices and enables interoperability among devices. however, the process of standardization is often very complicated and time consuming, especially in standardizing healthcare devices. health information can be very different ranging from physiological (ecg, body temperature, oxygen saturation, etc.) to physical (posture, activity, etc.). manufacturers tend to define their own proprietary formats and communication protocols. interoperability therefore becomes a major obstacle in integrating devices into healthcare systems. to resolve this issue, standard protocols such as the hl reference information model have been proposed for the integration of different sensing modalities. for instance, loh and lee proposed the use of an oracle healthcare transaction base (htb) system as the platform for integrating different information into a healthcare system [ ] . iso/ieee (x ), initially intended for the implementation of point-of-care devices, is now extended to personal health devices (phd) to address the interoperability problem. this standard provides the communication functionality for a variety of wearable devices (i.e., pulse oximeter, heart rate monitor, bp monitor, thermometer, etc.) and standardizes the format of information for plug-and-play interoperability [ ] . a recent study has validated the feasibility to apply this standard to wearable and wireless systems in home settings [ ] . to meet the needs of some scenarios with limited processing abilities, some amendments have been made based on this standard, such as the adapted data model proposed in [ ] and a new method to implement x phd in a microcontroller-based platform with low-voltage and low-power constraints [ ] . however, very few standards are available for evaluating the accuracy of wearable devices, albeit the necessity of standards to guarantee the reliability of these devices. for example, there are three well-known standards for assessing the accuracy of cuffbased bp measurement devices, i.e., the american association for the advancement of medical instrumentation (aami), the british hypertension society (bhs), and the european society of hypertension (esh). on the other hand, zhang's team has been spear-headed a standard for cuffless bp devices [ ] . in this work, a new distribution model of the measuring difference between the test and the reference device was proposed. the cumulative percentages (cp) of absolute differences between the test device and the reference derived by integrating the probability density function over the required range of limits (l) for normal and general t distribution are shown in ( ) and ( ), respectively: where u, d, and v denote mean, standard deviation, and degree of freedom, respectively. it was found that the agreement between the evaluation results of cuff-based devices by aami and bhs protocols was better for the proposed t distribution ( . %) than normal distribution ( %). the proposed error distribution model was further validated by the goodness-of-fit of datasets obtained from subjects by a ptt-based cuffless bp estimation method to the hypothesized distribution. in addition, this study also proposed new evaluation scales under general t distribution to assess the accuracy of cuffless bp devices, including: mean absolute difference (mad), root mean square difference (rmsd) and mean absolute percentage difference (mapd) as shown in ( ) and ( ) [ ] where s is the scale and equals to d × (v − )/π(v > ). based on ( ) and ( ), a mapping chart to relate the proposed scales with the aami, bhs, and esh evaluation criteria under t distribution was developed. on the other hand, personalization of wearable devices is also important. apart from personalizing the design of the devices, it can be referred to personalizing the sensor calibration, disease detection, medicine, and treatments. taking bp as an example: individualized bp calibration procedure is required for the ptt based unobtrusive bp measurement to ensure the accuracy. the calibration can be implemented through body movement such as hand elevation [ ] . on the other hand, from the perspective of personalized medicine, since bp can be very diverse among individuals, it is necessary to track a person's bp in long-term by wearable devices to establish an individual database for personalized bp management. this can lead to a more precise diagnosis and treatment. artificial intelligence enables autonomic functions of wearable devices, such as sending out alerts and supporting decision making. artificial intelligence may also refer to as context-awareness and useradaption [ ] . various classification methods such as hidden markov model, artificial neural networks, support vector machines, random forests, and neuro-fuzzy inference system have been extensively applied for various healthcare applications. the need of individualized training data, the lack of large scale studies in real-world situations, and the high rate of false alarms are some of the major obstacles that hinder the widespread adoption of sensing technologies in clinical applications. one of the major problems for wearable sensors is motion artifacts. the reduction of motion artifact is still a challenging problem for the development of wearable system due to the overlapping of its frequency band with the desired signal. several methods have been proposed for motion artifacts reduction. for instance, chung et al. [ ] presented a patient-specific adaptive neuro-fuzzy interference system (anfis) motion artifacts cancellation for ecg collected by a wearable health shirt. with anfis, it was able to remove motion artifacts for ecg in real time. adaptive filtering is another commonly used method for motion artifacts removal, and algorithms based on it have been applied for various applications. ko et al. [ ] proposed an adaptive filtering method based on half cell potential monitoring to reduce the artifacts on ecg without additional sensors. poh et al. [ ] embedded an accelerometer in an earring ppg fig. . various wearable garments for physiological and activity monitoring. (a) georgia tech wearable motherboard (smart shirt) for the measurement of ecg, heart rate, body temperature, and respiration rate [ ] ; (b) the ekg shirt system that used interconnection technology based on embroidery of conductive yarn for heart rate [ ] ; (c) the lifeshirt system for the measurement of ecg, heart rate, posture and activity, respiration parameters, bp (peripheral is needed), temperature, spo [ ] ; (d) the protex garment for the measurement of heart rate, breathing rate, body temperature, spo , position, activity, and posture [ ] ; (e) the wealthy system with knitted integrated sensors for the measurement of ecg, heart rate, respiration, and activity monitoring [ ] ; (f) the vtamn system for the measurement of heart rate, breathing rate, body temperature, and activity [ ] ; (g) the h-shirt system for the measurement of ecg, ppg, heart rate, and bp [ ] . sensor to obtain motion reference for adaptive noise cancellation. although adaptive filtering has shown to be an effective method, it requires extensive processing time, which hinders its real-time applications. yan and zhang [ ] developed a robust algorithm, called minimum correlation discrete saturation transform, which is more time efficient than discrete saturation transform that used adaptive filter. other methods, like independent component analysis and least mean square based active noise cancellation, have also been used to remove motion artifacts. in summary, the main issues to be addressed for the ubiquitous use of wearable technologies can be summarized as "super minds" (i.e., security, unobtrusiveness, personalization, energy efficiency, robustness, miniaturization, intelligence, network, digitalization, and standardization). more attentions should be paid to these aspects for the future development of wearable devices. smart textile technology is a promising approach for wearable health monitoring, since it provides a viable solution to integrate wearable sensors/actuators, energy sources, processing, and communication elements within the garment. some representative garment-based systems have been developed as shown in fig. . despite extensive progresses been made in wearable devices for physiological monitoring, little attention has been paid on the other health information such as biochemical and autonomic information that can provide a more comprehensive picture of fig. . flexible and stretchable wearable devices for health care applications developed by different groups: (a) multifunctional epidermal electronic device for electrophysiological, temperature, and strain monitoring [ ] ; (b) a flexible capacitive pressure sensor for radial artery pressure pulse measurement [ ] ; (c) e-skin with pressure and thermal sensors [ ] ; (d) a bandage strain sensor for breathing monitoring [ ] ; (e) electrochemical tattoo biosensors for real-time noninvasive lactate monitoring in human perspiration [ ] . the subject's health state. at this point, textile technology provides feasible solutions to the unobtrusive measurement of these new parameters. for instance, a textile-based sweat rate sensor has recently been developed, which measures the water-vapor pressure gradient by two humidity sensors at different distances from skin [ ] . textile-based ph sensor was also proposed using a colormetric approach with ph sensitive dyes and optoelectronics [ ] . in addition, poh et al. developed conductive fabric electrodes for unobtrusive measurement of electrodermal activity (eda), which can be used for long-term assessment of autonomic nerve activities during daily activities [ ] . this textile sensor has been designed into a wrist-worn device that can provide ambulatory monitoring of autonomic parameters for patients with refractory epilepsy. the strong correlation between eda amplitude and postictal generalized eeg suppression (pges) duration, an autonomic biomarker of seizure intensity, indicates that eda can be used as a surrogate measurement of pges for ambulatory monitoring of epilepsy and thus provides opportunity for the identification of sudden death in epilepsy [ ] . flexible electronics, where electronic circuits are manufactured or printed onto flexible substrates such as paper, cloth fabrics and directly on human body to provide sensing, powering, and interconnecting functions, have a broad range of biomedical applications. they have enabled the development of wearable devices to be thinner, lighter and flexible. the most common methods to fabricate these flexible sensors and other functional circuits on flexible substrates include: inkjet-printing, screen printing, transfer printing [ ] , low temperature deposition, etc. flexible electronics for health monitoring: fig. (b) to (e) shows some cutting-edge flexible wearable systems for health monitoring applications. for example, bao's team developed a high-sensitivity flexible capacitive pressure sensor with polydimethylsiloxane as the dielectric layer [ ] . by microstructuring the dielectric layer and integrating it in a thin-film polymer transistor, it is able to achieve very high sensitivity when driving the flexible pressure-sensitive transistor in the subthreshold regime. this device has been applied to measure a human radial artery pulse wave with high-fidelity as shown in fig. (b) [ ] . other examples include the e-skin with pressure and thermal sensors, and the flexible strain-gauge sensor for breathing monitoring as shown in fig. (c) and (d) [ ] , [ ] . some recent studies have proposed the fabrication of flexible photo-transistor [ ] , which can be used to build ppg sensors. these advances will effectively pave the way for unobtrusive physiological measurements in the future. in addition to the applications in physiological and physical monitoring, flexible electronic technology also begins to play a key role in biochemical sensing. a flexible "nano-electronic nose" was developed by michael et al. by transferring hundreds of prealigned silicon nanowires onto plastic substrate. it would open up new opportunities for wearable or implantable chemical and biological sensing [ ] . another example is the electrochemical tattoo biosensor recently developed by the research team from university of california san diego, as shown in fig. (e) [ ] . it can be easily worn on body for lactate monitoring during aerobic exercise. the performance of this tattoo sensor was evaluated in terms of its selectivity for lactate measurement, the ability of adhering to epidermal surface, and the robustness when exposed to mechanical stretching and bending. the results have showed its potential for unobtrusive and continuous monitoring of lactate during exercise [ ] . flexible sensors with inorganic, organic, and hybrid materials: a variety of organic and inorganic materials have been adopted for the development of flexible sensors. cnt is a very promising carbon based material for the design of flexible devices due to its unique mechanical and electrical properties. a flexible film strain sensor based on cnt has been designed and integrated into fabrics for human motion monitoring [ ] . it can endure strain up to % and achieve high durability of cycles at % strain as well as fast response of ms, which might be used for breath monitoring for the early detection of sudden infant death syndrome in sleeping infants. on the other hand, the printable feature and relative ease of fabrication process make organic materials suitable for the implementation of flexible wearable devices. flexible organic sensors employing thin-film transistor structure for skin temperature measurement and pressure sensing [ ] , [ ] have been proposed. due to the complementary benefits of inorganic and organic materials in terms of electrical conductivity, mechanical properties, and low-cost fabrication process, inorganic and organic hybrid materials have great potential for the development of high-performance flexible wearable devices. for example, a high-performance inorganic and organic hybrid photo detector based on p ht and nanowire was fabricated on a printing paper, which has high flexibility and electrical stability [ ] . lee's team fabricated a flexible organic light emitting diode with modified graphene anode to achieve extremely high efficiency [ ] . xu et al. developed an organic bulk heterojunction based near-infrared photo-transistor [ ] , which can be modified to a flexible device in the future. this device showed great potential for the design of low power ppg sensor due to its ultrahigh responsivity. pang et al. developed a flexible and highly sensitive strain-gauge sensor that is based on two interlocked arrays of high-aspect-ratio pt-coated polymeric nanofibres [ ] . this device is featured by its simple fabrication process as well as the ability of measuring different types of mechanical forces with high sensitivity and wide dynamic range. the assembled device has been used to measure the physical force of heart beat by attaching it directly above the artery of the wrist under normal and exercise conditions. in addition to the aforementioned advances in the design of flexible sensors, flexible technologies also enable other functional circuits such as an inkjet-printed flexible antenna for wireless communication [ ] , flexible batteries with wireless charger [ ] , flexible supercapacitors on graphene paper [ ] and cloth fabrics [ ] for wearable energy storage, etc. although significant advances have been made in flexible electronics, only limited applications in unobtrusive health monitoring have been explored until now. some key challenges still hinder the application of these systems in real life situations for wearable health monitoring, such as engineering new structural constructs from established and new materials to achieve higher flexibility, improving the durability of sensors and interconnects that are frequently exposed to mechanical load, integrating wireless data transmission and powering electronics with the flexible sensors, etc. stretchable electronics for health monitoring: flexible electronics already offers great opportunities in the applications of wearable health monitoring, but is not enough to ensure the conformal integration of the devices with arbitrary curved surfaces. stretchability, which enables the devices bend to extremely small radius and accommodate much higher strain while maintaining the electronic performance, is a more challenging characteristic and renders wider application possibilities. some stretchable systems for health monitoring applications have been proposed. one example is the epidermal electronic system developed by rogers' research group for measuring electrophysiological signals (ecg and emg), temperature, and strain, as shown in fig. (a) . the system consists of multifunctional sensors, processing unit, wireless transmission and powering, which are all mounted on an elastic polymer backing layer. the polymer sheet can be dissolved away, leaving only the circuits adhere to the skin via van der forces [ ] . one problem of this device is that it can easily fall off during bathing or exercise. therefore, they recently developed a new epidermal electronic system that has a total thickness of . m and can be directly printed onto the skin without the polymer backing. a commercially available spray-on bandage is then adopted as adhesives and encapsulants [ ] . other stretchable systems for biomedical applications have also been reported, such as the cnt-based strain sensor for human motion monitoring [ ] , electronic skin [ ] , and other as reviewed in [ ] . a number of methods have been proposed for the fabrication of stretchable electronics, such as led, conductors, electrodes, and thin-film transistors, and can be classified into two groups: exploring innovative structures and engineering new materials. rogers and coworkers [ ] configured the structures into wavy shapes supported by elastomeric substrate. the structure can accommodate up to %- % compressive and tensile strain by changing the wave amplitudes and wavelengths. this buckling approach has also been adopted to fabricate graphene ribbons on stretchable elastomers [ ] . rogers and coworkers also proposed a noncoplanar mesh design with active device islands connected by thin polymer bridges on elastomeric substrates to achieve % level of strain [ ] . recently, white et al. [ ] demonstrated an ultrathin, flexible and stretchable polymer-based light emitting diode (pled), which can be fabricated with very simple processing method. by pressed onto a prestrained elastomer, the ultrathin pled formed a random network of folds when releasing the strain on the elastomer. the experiment showed that the ultrathin pled can be stretched up to % tensile strain. meng et al. [ ] designed and fabricated the assembled fiber supercapacitors composed of two intertwined graphene electrodes that showed highly compressible (strain of %) and stretchable (strain of %) properties, and can be easily woven into textile for wearable applications. new materials can also provide stretchability for electronics. someya's group fabricated a composite film by uniformly dispersing single-walled cnts in polymer matrices [ ] . other stretchable electronics based on nanocomposites such as gold nanoparticle-polyurethane composite as conductor [ ] , graphene oxide nanosheet-conducting polymer as electrode [ ] have also been proposed recently. these nanocomposites achieved both good electronic performance and mechanical robustness. these recent advancements in stretchable electronics will facilitate the adoption of these technologies in healthcare applications. to summarize, with the advances in material, textile, power scavenging, sensing and wireless communications, there has been a rapid increase in the number of new wearable sensing devices launched in the consumer market for sports, wellbeing and healthcare applications. considering the growing interests in these research areas, the number and variety of sensors will continue to grow in a very rapid rate. in addition, following the current trend of sensing development, new type of implantable sensors, such as transient and zero-power implants, could soon become reality. standards have been emerged aiming to standardize these devices as well as the wireless communication and the exchange of information among devices and systems. the development of sensing technology has largely increased the capability of sensor to acquire data, and multiple sensors are expected to provide different viewpoints of the health status of the patients. however, multisensor data fusion is one great challenge because heterogeneous data need to be processed in order to generate unified and meaningful conclusion for clinical diagnosis and treatment [ ] . the fusion of sensing data with other health data such as imaging, bio-markers and gene sequencing and so on is even more challenging. the definitions of data fusion are different in the literature. in [ ] , data fusion is defined as a "multilevel, multifaceted process handling the automatic detection, association, correlation, estimation, and combination of data and information from several sources". a comprehensive review and discussion of data fusion definitions are presented in [ ] . we propose the definition of data fusion as: "to develop efficient methods for automatically or semi-automatically translating the information from multiple sources into a structured representation so that human or automated decision can be made accurately". data fusion is definitely a multidisciplinary research area, which has integrated many techniques, such as signal processing, information theory, statistical estimation and inference, and artificial intelligence. in this section, we will discuss multisensor fusion methods and the fusion of sensing data with other types of health data for clinical decision support. at the end of this section, we will provide a critical on the impact of big data in the healthcare area. since most of health data are accompanied with a large number of noisy, irrelevant and redundant information, which may give spurious signals in clinical decision support, it is therefore necessary to filter the data before fusion. to address this issue, ranked lists of events or attributes clearly relevant to clinical decision-making should be created [ ] . temporal reasoning method has been suggested for detecting associations between clinical entities [ ] . more sophisticated methods such as contextual filters [ ] , statistical shrinkage towards the null hypothesis of no association [ ] were also proposed. how to filter information is definitely clinically meaningful, and it would become more and more important but challenging due to the ever-increasing data types and volumes. multisensor fusion: a number of algorithms have been proposed in the literature for multisensor data fusion. due to heterogeneous nature of the data that need to be combined, different data fusion algorithms have been designed for different applications. these algorithms can utilize different techniques from a wide range of areas, including artificial intelligence, pattern recognition, statistical estimation, and other areas. health informatics has naturally benefited from these abundant literature. for instance, these fusion algorithms can be categorized into the following groups: ) statistical approach: weighted combination, multivariate statistical analysis and its most state-of-the-art data mining algorithm [ ] . among all the statistical algorithms, the arithmetic mean approach is considered as the simplest implementation for data fusion. however, the statistical approach might not be suitable when the data is not exchangeable or when estimators/classifiers have dissimilar performances [ ] . ) probabilistic approach: maximum likelihood methods and kalman filter [ ] , probability theory [ ] , evidential reasoning and more specifically evidence theory are widely used for multisensor data fusion. kalman filter is considered as the most popular probabilistic fusion algorithm because of its simplicity, ease of implementation, and optimality in a mean-squared error sense. however, kalman filter is inappropriate for applications whose error characteristics are not readily parameterized. ) artificial intelligence: artificial cognition including genetic algorithms and neural networks. in many applications, the later approach serves both as a tool to derive classifiers or estimators and as a fusion framework of classifiers/estimators [ ] , [ ] . fusion of sensing data with other health data: it is of vital importance to integrate sensing data with other health data, including genetic, medication, laboratory test, imaging data and narrative reports that provide context information for clinical diagnosis. electronic health record (ehr) reposits these health data in a computer-readable form, which can be used for clinical decision support [ ] . the heterogeneous contents and huge size of ehr bring great challenges for the fusion of these data. bayesian network, neural networks, association rules, pattern recognition and logistic regression have been used to extract knowledge from ehr for patient stratification and predictive purposes in the past years. these methods offer significant advantages to traditional statistical methods because they are able to identify more complex relationships among variables. a comparison has been made among the three different classification methods in terms of their performance in predicting coronary artery disease [ ] . it was found that the multilayer perceptron based neural network method showed the best performance in prediction [ ] . although these studies have shown promising results about the effectiveness of these computerized methods to be a complementary tool of the present statistical models for medical decision support, these methods still suffer from some problems, such as over fitting, computationally expensive, and some of them are difficult to be interpreted by experts. unlike these completely data-driven approaches, fuzzy cognitive map (fcm) is a logical-rule-based method constructed from human experts' knowledge. it models the decision system as a collection of concepts and causal relationships among these concepts using fuzzy logic and neural networks [ ] . it, therefore, can be interpreted by experts and provides transparent information to the experts. however, it could be subjective and may not be reliable by solely relying on experts' knowledge to generate the rules. a new fcm framework was proposed recently [ ] , which extracts fuzzy rules from both experts' knowledge and data using rule extraction methods. this novel framework for fcm system has been used in the radiation therapy for prostate cancer. the early prediction of cardiovascular diseases (cvds) has been a very popular yet challenging research topic, and many fusion works have been conducted in this area. for instance, in an european commission funded project, euheart project, a probabilistic fusion framework was developed to assimilate different health data across scales (e.g., protein level ion channels flux and whole organ deformation) and functions (e.g., mechanical contraction and electrical activation), into a personalized multiphysics cardiac model by minimizing on the discrepancy between the measurements and the estimating derived from the computational model and then to discover new knowledge using the personalized model [ ] . by integrating continuous and real-time sensing data from unobtrusive/wearable devices with the existing health data, the real-time prediction of acute cvd events may become possible. zhang's team has proposed a personalized framework for quantitative assessment of the risk of acute cvd events based on vulnerable plaque rupturing mechanism as shown in fig. [ ] . this framework does not only take traditional risk factors, sensitive biomarkers, blood biochemistry, vascular morphology, plaque information, and functional image information as inputs of the prediction model, but also gathers physiological information continuously from unobtrusive devices and body sensor networks as the trigger factors targeting for real-time risk assessment of acute cardiovascular events. with the increasing number of sensing modalities and low cost sensing devices becoming more accessible to wider populations, the amount and variety of health data have increased rapidly, health data are therefore considered as big data. for example, if we collect the health data related to cardiovascular system, including ecg, ppg, bp waveform, bcg, eeg, emg, ptt, cardiac output, spo , body temperature, and imaging information from computed tomography, magnetic resonance imaging, ultrasound imaging and so on, the size of data collected from all the people in the southern china, from all the people in the china, and from all over the world, are over zettabytes, zettabyes, and over zettabytes per year, respectively. as of year , the size of data sets that are feasible to process in a reasonable amount of time were in the order of exabytes, which means the size of health data is over one thousand times larger than the current limits. based on the " v" definition of big data by gartner, i.e., volume, velocity, variety and value, the characteristics of health data can be summarized as " v": vast, volume, velocity, variety, value, variation. vast is the core feature of health data, i.e., the volume, velocity, variety, value and variation are vast. volume refers to the size of the information. because health data are collected from over a huge amount of people simultaneously, the velocity of the collection of health data can be extremely high. a variety of health data from genetic or molecular level like gene sequences and biomarkers to system levels such as physiological parameters and medical imaging data are now available. if we can build up a systematic analysis framework, we can definitely mine knowledge of great value from the health data. since the biological system of the human being is dynamic and evolving, the health data must be variational. due to the ongoing developments of network, mobile computing and computer storage, the storage and retrieval of big health data have attracted great attentions. with the increasing use of various kinds of long-term monitoring devices, there is an urgent demand for the intelligent management of big health data. a large number of cloud-based storage and retrieval systems are emerging in recent years. through outsourcing the big health data, storage-as-a-service is an emerging solution to alleviate the burden and high cost of large local data storage. some new storage strategies have been proposed, such as storage consolidation and virtualization to optimize the tradeoff between computation and storage capacity [ ] . retrieving specific information from the cloud-based health data is also very challenging. query accuracy and time efficiency are two important metrics to evaluate the performance of the retrieval system. extensive efforts have been made on optimizing the query complexity and expansion strategies to improve the performance of fig. . the framework for the quantitative assessment of the risk of acute cardiovascular events. reproduced from [ ] . the retrieval systems [ ] , [ ] . recently, a standards-based model has been proposed to provide a feasible solution for the management (i.e., collection, storage, retrieval and sharing) of patient-generated personal health data in ehr [ ] . this model described the required components and minimal requirements for data collection and storage, as well as the method for the exchange of health data between patients and ehr providers. up to date, a number of healthcare applications based on cloud computing technology have been reported, such as storage and management of ehrs [ ] , automatic health data collection in health care institutions [ ] , intelligent emergency health care [ ] , radiotherapy, etc. it will further provide opportunities in clinical decision support (particularly for chronic diseases), public health management (e.g., controlling of infectious diseases), development of new drugs, etc [ ] , [ ] . although many cloud-based storage and retrieval systems have recently been proposed, fusion techniques for analyzing big health data are still in the conceptual stage, we believe that with the advances of computing power as well as the increasing availability of more and more interoperable electronic health records in the healthcare ecosystems, the intelligent utilization of big health data will eventually become feasible in the near future. in this paper, an overview of unobtrusive sensing platforms either in wearable form or integrated into environments is presented. although significant progresses in developing these systems for healthcare applications have been made in the past decades, most of them are still in their prototype stages. issues such as user acceptance, reduction of motion artifact, low power design, on-node processing, and distributed interference in wireless networks still need to be addressed to enhance the usability and functions of these devices for practical use. due to the mul-tidisciplinary nature of this research topic, future development will greatly rely on the advances in a number of different areas such as materials, sensing, energy harvesting, electronics and information technologies for data transmission and analysis. in the following, we put forward some promising directions on the development of unobtrusive and wearable devices for future research: ) to develop flexible, stretchable and printable devices for unobtrusive physiological and biochemical monitoring: research on a variety of semiconductor materials, including small-molecule organics and polymers, inorganic semiconducting materials of different nanostructures, like nanotube, nanowire, and nanoribbons and hybrid composite materials, could prosper the design of flexible and stretchable sensors with high optical, mechanical and electrical performance. with the development of flexible, stretchable and printable electronics, wearable devices would evolve to be multifunctional electronic skins or skin-attachable devices, which are very comfortable to wear. meanwhile, other applications of flexible and stretchable devices in wearable health monitoring should be explored. ) to develop wearable physiological imaging platforms, especially unobtrusive ones: physiological information provided by the present wearable systems are generally in one-dimensional ( -d) format. the extension from -d to -d by including spatial information would be desirable to provide more local information. compared to the existing noninvasive imaging modalities (e.g., magnetic resonance imaging, computed tomography, ultrasound, etc.), wearable physiological imaging devices would be much faster to achieve high temporal resolution images, which is expected to provide additional clinical and health information for early diagnosis and treatment of diseases. the existing wearable devices are mainly designed for the continuous monitoring of a person's physiological or physical status. for future development, wearable devices should also play a role in disease intervention through integration with actuators that are implanted inside/on the body. one well-known example is the wearable artificial endocrine pancreas for diabetes management, which is a close-loop system formed by a wearable glucose monitor and an implanted insulin pump. wearable drug delivery systems for bp management can also be developed in the future. ) to develop systematic data fusion framework: to integrate the multimodal and multiscale big health data from sensing, blood testing, bio-marker detection, structural and functional imaging for the quantitative risk assessment and the early prediction of chronic diseases. it is believed that with these future developments, unobtrusive and wearable devices could advance health informatics and lead to fundamental changes of how healthcare is provided and reform the underfunded and overstretched healthcare systems. the global economic burden of non-communicable diseases editorial note on the processing, storage, transmission, acquisition, and retrieval (p-star) of bio, medical, and health information m-health: the development of cuff-less and wearable blood pressure meters for use in body sensor networks epidermal electronics health informatics: unobtrusive physiological measurement technologies contactless and cuffless monitoring of blood pressure on a chair using e-textile materials a smart health monitoring chair for nonintrusive measurement of biological signals the smart car seat: personalized monitoring of vital signs in automotive applications a novel method for the contactless and continuous measurement of arterial blood pressure on a sleeping bed a medical mirror for non-contact health monitoring a fast and easy-to-use ecg acquisition and heart rate monitoring system using a wireless steering wheel a natural contact sensor paradigm for nonintrusive and realtime sensing of biosignals in human-machine interactions the electrically noncontacting ecg measurement on the toilet seat using the capacitivelycoupled insulated electrodes noninvasive measurement of physiological signals on a modified home bathroom scale non-contact low power eeg/ecg electrode for high density wearable biopotential sensor networks respiratory monitoring system on the basis of capacitive textile force sensors a differential capacitive electrical field sensor array for contactless measurement of respiratory rate an ultrawearable, wireless, low power ecg monitoring system wireless and non-contact ecg measurement system-the aachen smartchair development of a wireless capacitive sensor for ambulatory ecg monitoring over clothes a textile integrated longterm ecg monitor with capacitively coupled electrodes wireless non-contact eeg/ecg electrodes for body sensor networks a wireless wearable ecg sensor for long-term applications non-contact ecg sensing employing gradiometer electrodes photoplethysmogram measurement without direct skin-to-sensor contact using an adaptive light source intensity control advancements in noncontact, multiparameter physiological measurements using a webcam mobile monitoring with wearable photoplethysmographic biosensors motion resistant earphone located infrared based heart rate measurement device a wearable reflectance pulse oximeter for remote physiological monitoring multichannel reflective ppg earpiece sensor with passive motion cancellation in-ear vital signs monitoring using a novel microoptic reflective sensor wearable wireless photoplethysmography sensors a flexible, low noise reflective ppg sensor platform for ear-worn heart rate monitoring a novel headset with a transmissive ppg sensor for heart rate measurement cardiovascular monitoring using earphones and a mobile device motion-tolerant magnetic earring sensor and wireless earpiece for wearable photoplethysmography a clipfree eyeglasses-based wearable monitoring device for measuring photoplethysmograhic signals a driver's physiological monitoring system based on a wearable ppg sensor and a smartphone reliable pulse rate evaluation by smartphone modeling of pulse transit time under the effects of hydrostatic pressure for cuffless blood pressure measurements cuff-less and noninvasive measurements of arterial blood pressure by pulse transit time pulse transit time measured from the ecg: an unreliable marker of beat-to-beat blood pressure comparative evaluation of susceptibility to motion artifact in different wearable systems for monitoring respiratory rate a wearable health care system based on knitted integrated sensors film-type sensor materials pvdf and emfi in measurement of cardiorespiratory signals: a review a new method to measure heart rate with emfi and pvdf materials design and implementation of sensing shirt for ambulatory cardiopulmonary monitoring a multimodal transducer for cardiopulmonary activity monitoring in emergency monitoring respiration and cardiac activity using fiber bragg grating-based sensor a system for respiratory motion detection using optical fibers embedded into textiles microwave fmcw doppler radar implementation for in-house pervasive health care system towards core body temperature measurement via close proximity radiometric sensing ambulatory assessment of ankle and foot dynamics a low-power wireless ecg necklace for reliable cardiac activity monitoring on-the-move a h-shirt-based body sensor network for cuffless calibration and estimation of arterial blood pressure bayesian analysis of sub-plantar ground reaction force with bsn photonic textiles for pulse oximetry a stretchable carbon nanotube strain sensor for human-motion detection a mobile-phone-based health management system," in health management-different approaches and solutions sensor positioning for activity recognition using wearable accelerometers champion trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system ambulatory esophageal ph monitoring using a wireless system perspectives on high technologies for low-cost healthcare towards miniaturization of a mems-based wearable motion capture system mechanically flexible wireless multisensor platform for human physical activity and vitals monitoring a low-power, battery-free tag for body sensor networks fabric-based active electrode design and fabrication for health monitoring clothing guest editorial introduction to the special section on m-health: beyond seamless mobility and global wireless health-care connectivity body sensor networks performance analysis of low rate wireless technologies for medical applications design and qos of a wireless system for real-time remote electrocardiography enhanced protocol for real-time transmission of echocardiograms over wireless channels medical qos provision based on reinforcement learning in ultrasound streaming over . g wireless systems monitoring patients via a secure and mobile healthcare system implementation of elliptic-curve cryptography on mobile healthcare devices body sensor network security: an identity-based cryptography approach a novel biometrics method to secure wireless body area sensor networks for telemedicine and mhealth pska: usable and secure key agreement scheme for body area networks plethysmogram-based secure inter-sensor communication in body area networks efficient security mechanisms for mhealth applications using wireless body sensor networks public key cryptographybased security scheme for wireless sensor networks in healthcare advanced rechargeable lithiumion batteries based on bendable znco o -urchins-on-carbon-fibers electrodes fiber supercapacitors utilizing pen ink for flexible/wearable energy storage a high-sensitivity near-infrared phototransistor based on organic bulk heterojunction power-conscious design of wireless circuits and systems energy scavenging with shoe-mounted piezoelectrics thermoelectric energy harvesting of human body heat for wearable sensors midfield wireless powering of subwavelength autonomous devices digital sampling rate and ecg analysis approximate reconstruction of bandlimited functions for the integrate and fire sampler time-based compression and classification of heartbeats medical informatics system with wireless sensor network-enabled for hospitals health informatics personal health device communication, ieee standard p applying the iso/ieee standards to wearable home health monitoring systems ambient assisted living devices interoperability based on osgi and the x standard implementation methodology for interoperable personal health devices with low-voltage low-power constraints evaluation scale to assess the accuracy of cuff-less blood pressure measuring devices mopet: a context-aware and user-adaptive wearable system for fitness training motion artifacts cancellation by adaptive neuro-fuzzy inference system for wearable health shirts motion artifact reduction in electrocardiogram using adaptive filtering based on half cell potential monitoring an efficient motion-resistant method for wearable pulse oximeter biotex-biosensing textiles for personalised healthcare management autonomic changes with seizures correlate with postictal eeg suppression a wearable sensor for unobtrusive, long-term assessment of electrodermal activity wireless communication of vital signs using the georgia tech wearable motherboard fully untegrated ekg shirt based on embroidered electrical interconnections with conductive yarn and miniaturized flexible electronics the lifeshirt: a multi-function ambulatory system monitoring health, disease, and medical intervention in the real world smart garments for emergency operators: the proetex project vtamn -a smart clothe for ambulatory remote monitoring of physiological parameters and activity multifunctional epidermal electronics printed directly onto the skin highly sensitive flexible pressure sensors with microstructured rubber dielectric layers flexible polymer transistors with high pressure sensitivity for application in electronic skin and health monitoring building bionic skin regulating infrared photoresponses in reduced graphene oxide phototransistors by defect and atomic structure control highly ordered nanowire arrays on plastic substrates for ultrasensitive flexible chemical sensors electrochemical tattoo biosensors for real-time noninvasive lactate monitoring in human perspiration pressure sensing using a completely flexible organic transistor ultraflexible solution-processed organic field-effect transistors high-performance organic-inorganic hybrid photodetectors based on p ht:cdse nanowire heterojunctions on rigid and flexible substrates extremely efficient flexible organic lightemitting diodes with modified graphene anode a flexible and highly sensitive strain-gauge sensor using reversible interlocking of nanofibres progress towards the first wireless sensor networks consisting of inkjetprinted, paper-based rfid-enabled sensor tags stretchable batteries with selfsimilar serpentine interconnects and integrated wireless recharging systems flexible energy storage devices based on graphene paper inkjet printing of singlewalled carbon nanotube/ruo nanowire supercapacitors on cloth fabrics and flexible substrates flexible and stretchable electronics for biointegrated devices a stretchable form of single-crystal silicon for high-performance electronics on rubber substrates super-elastic graphene ripples for flexible strain sensors mechanics of noncoplanar mesh design for stretchable electronic circuits ultrathin, highly flexible and stretchable pleds all-graphene core-sheath microfibers for allsolid-state, stretchable fibriform supercapacitors and wearable electronic textiles a rubberlike stretchable active matrix using elastic conductors stretchable nanoparticle conductors with selforganized conductive pathways nanocomposites of reduced graphene oxide nanosheets and conducting polymer for stretchable transparent conducting electrodes multisensor data fusion: a review of the state-of-the-art data fusion lexicon on the definition of information fusion as a field of research feature selection and classification model construction on type diabetic patients' data knowledge-data integration for temporal reasoning in a clinical trial system selecting information in electronic health records for knowledge acquisition temporal pattern discovery in longitudinal electronic patient records data mining concepts and techniques optimal linear combinations of neural networks an expectation-maximization-based interacting multiple model approach for cooperative driving systems possibility theory mining electronic health records: towards better research applications and clinical care comparing performances of logistic regression, classification and regression tree, and neural networks for predicting coronary artery disease knowledge processing with fuzzy cognitive maps a new methodology for decisions in medical informatics using fuzzy cognitive maps based on fuzzy rule-extraction techniques euheart-matters of the heart risk prediction of cardiovascular disease a highly practical approach toward achieving minimum data sets storage cost in the cloud towards effective genomic information retrieval: the impact of query complexity and expansion strategies an analysis of clinical queries in an electronic health record search utility a standards-based model for the sharing of patient-generated health information with electronic health records looking at clouds from both sides: the advantages and disadvantages of placing personal narratives in the cloud a cloud computing solution for patient's data collection in health care institutions emergency healthcare process automation using mobile computing and cloud services opportunities and challenges a pilot study of distributed knowledge management and clinical decision support in the cloud authors' photographs and biographies not available at the time of publication key: cord- -mkr n i authors: mah, catherine l. title: what’s public? what’s private?: policy trade-offs and the debate over mandatory annual influenza vaccination for health care workers date: - - journal: can j public health doi: . /bf sha: doc_id: cord_uid: mkr n i policy decisions about public health services differ from those for personal health services. both require trade-offs between such policy goals as liberty, security, efficiency, and equity. in public health, however, decisions about who will approve, pay for, and deliver services are often accompanied by decisions on when and how to compel individual behaviour. policy becomes complex because different stakeholders interpret evidence differently: stakeholders may assign different weights to policy goals and may even define the same goals differently. in the debate over mandatory annual influenza vaccination for health care workers, for example, proponents as well as opponents of mandatory vaccination may convey arguments in security terms. those in favour of mandatory vaccination emphasize subclinical infections and duty of care (public security) while those opposed emphasize risk of adverse events (personal security). proponents assert less worker absenteeism (efficiency) while opponents stress coercion and alternate personal infection control measures (liberty and individual rights/responsibilities). consequently, stakeholders talk past each other. determining the place of mandatory influenza vaccination for health care workers thus demands reconciling policy trade-offs and clarifying the underlying disputes hidden in the language of the policy debate. les décisions concernant l'orientation des services de santé publique diffèrent de celles qui portent sur les services de santé individuelle. les deux nécessitent des compromis entre les objectifs visés, que ce soit la liberté, la sécurité, l'efficacité ou l'équité. en santé publique toutefois, quand on a décidé qui doit approuver, payer et fournir les services, il faut souvent décider en plus quand et comment imposer des comportements individuels. les politiques de santé publique sont donc plus complexes, car les différents intervenants interprètent les données différemment : ils n'accordent pas nécessairement la même importance à chaque objectif stratégique et peuvent même définir autrement des objectifs identiques. dans le débat sur l'imposition ou non du vaccin antigrippal annuel aux travailleurs de la santé, par exemple, les partisans et les adversaires de la vaccination obligatoire peuvent invoquer la sécurité dans leurs arguments. ceux qui sont pour la vaccination obligatoire insistent sur les infections subcliniques et le devoir de diligence (la sécurité publique), tandis que ceux qui sont contre insistent plutôt sur le risque d'effets secondaires (la sécurité personnelle). les partisans préconisent une diminution de l'absentéisme chez les travailleurs (l'efficacité), tandis que les adversaires mettent en garde contre la coercition et préfèrent d'autres mesures personnelles de contrôle des infections (liberté et droits/responsabilités individuels). on assiste par conséquent à un dialogue de sourds. si l'on veut déterminer l'importance à accorder à la vaccination antigrippale obligatoire des travailleurs de la santé, il faut donc concilier les compromis stratégiques et clarifier les différends qui se cachent sous les mots utilisés dans le débat d'orientation des politiques. mots clés : politiques publiques; personnel médical et paramédical; lois; immunisation; pratiques de santé publique t he question of mandatory annual influenza vaccination for health care workers arises regularly in the process of influenza policy planning. terms such as "duty of care," "autonomy," and "rights" are wielded with considerable force by a variety of well-intentioned stakeholders. the following commentary addresses the policy challenges represented in the language used by proponents and opponents of mandatory annual influenza vaccination for health care workers, in an attempt to shed light on this heated debate. the question of mandatory annual influenza vaccination fits within the rubric of public health. definitions of what constitutes public health differ in terms of scope (scale of the community or population), intent (freedom from disease versus complete well-being), and function ("core" functions versus broad social determinants of health). in comparison with personal health services, however, it is generally accepted that public health incorporates the following dimensions: . public health is principally concerned with the health of populations rather than individuals. . public health assumes that certain goods cannot be provided adequately through market mechanisms; they cannot be restricted to those who wish to pay for them. this is also true for personal health services. in public health, however, the actions of individuals frequently have consequences for others that may not be predictable or apparent (externalities). these externalities may be negative (increased risk of infectious disease transmission) or positive ("herd" immunity). when positive and known, externalities can induce the "free-rider" problem: for example, individuals might be less likely to assume personal risks related to vaccination if they know that they are protected by herd immunity. the free-rider problem is sometimes used as a justification for coercion of individuals: for example, compulsory vaccinations. . public policy for health services recognizes that individuals acting solely in their own interests cannot adequately provide for the health of the popula-tion at large. the corollary is that collective action by the government on the part of its populace is required to achieve a state of public health, including protecting the public against identifiable health risks. , to the extent that governments act to constrain the actions of individuals in the public interest, public health policies represent the exercise of legitimate authority by a government; coercive or not. , , decisions on the financing, delivery and allocation of health services are accompanied by decisions on when and how to compel individual behaviour in the public interest. the issue of mandatoriness, or compulsion (through regulation), is therefore central to the mandatory influenza vaccination debate and should be separated from the issue of the perceived risks and benefits of vaccination itself. mandatory vaccination regulations have long been employed by governments as a public health policy instrument and have been supported by constitutional and common law jurisprudence in the us context. , in canada, a number of statutes and regulations at the federal and provincial/territorial levels govern immunization. from a policy perspective, mandatory vaccination regulations illustrate the tradeoffs that are central to public policy. as deborah stone has observed, four goals or values dominate the policy discourse: equity, efficiency, liberty, and security. policy decisions for the provision of goods such as health care rest largely on the trade-offs between these goals. the trade-off between security and liberty, or in other terms, a government's responsibility to reduce risk in the community and the rights of individuals as protected by law, is highlighted in public health. canadian federal and provincial requirements for compulsory vaccination, for example, are tempered by the presence of individual legal exemptions on religious, medical, or philosophical grounds. should health care workers undergo voluntary annual influenza vaccination? was the ontario government just in its efforts to impose compulsory influenza vaccination for paramedics in ? are there conditions under which mandatory vaccination of health care workers is fair? do the conditions differ for physicians in private offices versus hospital workers? how about volunteers? should mandatory influenza vaccination for health care workers be seen as protecting the public (public health context) or health care workers themselves (occupational health context)? should health care workers be required to take antiviral drugs in addition to/in lieu of vaccination? such questions illustrate the nuances in the tensions between security and liberty at the heart of the debate. as gostin has asked: "how do we know when the public good to be achieved is worth the infringement of individual rights?" complexity in the security/liberty problem also arises through issues unique to vaccination, in general, and annual influenza vaccination, in particular. first, vaccination clearly constitutes a medical intervention. compared to public health regulations such as smoking bans in public spaces, vaccination poses a palpable risk to the individual undergoing the intervention. second, vaccination is unique in that it serves a preventive rather than treatment function in the protection of the public's health. compared with other medical interventions such as compulsory antimicrobial treatment for communicable diseases, mandatory vaccination requires a clear assessment of immediate as well as long-term costs and benefits. finally, annual influenza is exceptional in that vaccines must be modified and readministered annually, according to the shifts in the immune make-up of the predominant viruses circulating worldwide each year. compared to one-time, "emergency" situations where liberty may be more easilyand arguably justifiably -overridden, compulsory annual influenza vaccination requires repeated impositions on the individual. one of the central difficulties in the current state of the mandatory vaccination debate is apparent in contradictions in the language used. different stakeholders interpret evidence differently; stakeholders may assign different weights to policy goals and may even define the same goals differently. consequently, stakeholders talk past each other. consider, for example, arguments emphasizing the "duty of care." [ ] [ ] [ ] [ ] [ ] [ ] [ ] such arguments frame the debate in terms of communal good over individual rights: an explicit valuing of security over liberty. "duty of care" suggests professional responsibility, which in public health has wider connotations than for personal care. public health professionals need to confront the question of to whom they owe a duty of loyalty. , to what extent are health care workers responsible for potentially vulnerable populations, or the community at large? to what extent are health care workers justified in valuing personal interests over those of their patients -and potential patients? in contrast, the language of "coercion" and "voluntary measures" highlights liberty issues, in both the negative (freedom from interference -the right to be free) and positive (freedom to act -opportunity) connotations. "duty of care" arguments thus talk past the opponents of mandatory vaccination, who stress coercion and the effectiveness of alternate personal infection control measures. even if policy-makers were to agree on a single goal, it would still be subject to ideological and normative assumptions. proponents of mandatory influenza vaccination, for example, may assert decreased worker absenteeism as a result of vaccination. though in part a security argument -for decrease in infectious risk to and stability of the health care workforce -this justification also suggests efficiency gains. efficiency also has normative -and negative -connotations: inefficiency means waste. similarly, the idea of security is complex because defining what individuals or societies "need" to be secure includes diverse dimensions. the definition of security in the public health context is particularly problematic because security arguments might be more compelling for specific conditions or in certain populations where ease or risk of disease transmission is high. in terms of language, proponents as well as opponents of mandatory vaccination may convey their arguments in security terms; proponents emphasize subclinical infections among workers and duty of care (public security) while opponents emphasize risk of adverse events (personal security/negative liberty). analysis of voluntary vaccination reveals similar disputes about the meaning of security: simeonsson et al.'s review suggests that "self-protection and personal health" are the top reasons for health worker acceptance of voluntary annual influenza vaccine, while the top reason for non-acceptance was "side effects." in both cases, workers have implied a valuing of personal security over public security. whether mandatory vaccination is "right" or "wrong," "fair," or "just" thus depends on a clear examination of which policy goals we want to achieve as a society. decision models in health care policymaking for personal health services have long taught us that different stakeholders assign different utilities or values to different health outcomes. a "rational" weighing of the evidence may not be sufficient to allow us to make good policy decisions, particularly when the public interest is at stake. in public health policy, recognition of shared goals is paramount. "good" intent, or even "good evidence," cannot be taken for granted as the sole prerequisite for public health policy decisions. determining the place of mandatory vaccination for health care workers demands reconciling policy trade-offs; the first step should be to clarify the underlying disputes hidden in the language of the policy debate. public health, ethics, and human rights: a tribute to the late jonathan mann public health law: power, duty, restraint learning from sars: renewal of public health in canada principles for the justification of public health intervention the end of liberalism: the second republic of the united states health care reform: lessons from canada school vaccination requirements: historical, social, and legal perspectives legislative and regulatory framework for reportable infectious diseases in canada: overview of compendium, draft available online at policy paradox: the art of political decision making, revised edition cats and categories: public and private in canadian healthcare public health law: power, duty, restraint individual rights, collective good and the duty of care national advisory committee on immunization. statement on influenza vaccination for the - season mandatory immunization of health care providers: the time has come influenza vaccination of health care workers: a duty of care semmelweis revisited: the ethics of infection prevention among health care workers requiring influenza vaccination for health care workers: seven truths we must accept counterpoint: in favour of mandatory influenza vaccine for all health care workers virulent epidemics and scope of healthcare workers' duty of care two concepts of liberty point: mandatory influenza vaccination for all health care workers? seven reasons to say randomized, placebocontrolled double blind study on the efficacy of influenza immunization on absenteeism of health care workers influenza vaccination of health care workers: institutional strategies for improving rates key: cord- -h hxroos authors: wielinga, peter r.; schlundt, jørgen title: one health and food safety date: - - journal: confronting emerging zoonoses doi: . / - - - - _ sha: doc_id: cord_uid: h hxroos many, if not most, of all important zoonoses relate in some way to animals in the food production chain. therefore food becomes an important vehicle for many zoonotic pathogens. one of the major issues in food safety over the latest decades has been the lack of cross-sectoral collaboration across the food production chain. major food safety events have been significantly affected by the lack of collaboration between the animal health, the food control, and the human health sector. one health formulates clearly both the need for, and the benefit of cross-sectoral collaboration. here we will focus on the human health risk related to zoonotic microorganisms present both in food animals and food derived from these animals, and typically transmitted to humans through food. some diseases have global epidemic—or pandemic—potential, resulting in dramatic action from international organizations and national agricultural- and health authorities in most countries, for instance as was the case with avian influenza. other diseases relate to the industrialized food production chain and have been—in some settings—dealt with efficiently through farm-to-fork preventive action in the animal sector, e.g. salmonella. finally, an important group of zoonotic diseases are ‘neglected diseases’ in poor settings, while they have been basically eradicated in affluent economies through vaccination and culling policies in the animal sector, e.g. brucella. here we will discuss these three different foodborne disease categories, paying extra attention to the important problem of antimicrobial resistance (amr). in addition, we present some of the one health inspired solutions that may help reduce the threat of several of the foodborne diseases discussed. people in ancient times already understood they could get sick from consumption of infected meat. by keeping their animals healthy, and by using dedicated methods of food preparation and conservation, ancient farmers learned how to improve health and prevent disease. probably the oldest written document about it is 'on airs, waters, and places', written by hippocrates, which describes how human health is influenced by its interaction with the environment. since then, our health situation has improved by applying these simple rules of thumb, and even more through improved technologies such as good animal management, hygiene and biosecurity, vaccination programs and prudent animal drug treatment. nowadays, some of the most feared zoonotic diseases such as anthrax or brucellosis are absent in many countries. however, there are still many important diseases that threaten human health and which have animals as their reservoir. these animal reservoirs range from wildlife to domestic animals, both in companionship and agricultural settings. by the obvious close contact and the sheer number of animals needed for consumption, the animals produced for food form the largest reservoir and production grounds for emerging zoonotic pathogens. actions of authorities to protect society from zoonotic diseases differ significantly according to socio-economic status and the zoonotic pathogen in question. basically, zoonotic diseases related to food animals can be separated into three groups. in the first group are diseases with a potential for global spread and with a dramatic public relations potential, often these diseases have a significant human reservoir showing human-human transmission, e.g. sars, avian influenza and certain types of amr bacteria. the second group is constituted by persistent zoonotic diseases related to the industrialized food production chain, such as salmonella and campylobacter, which are broadly distributed in the farm-to-fork chain. these human pathogens are often non-pathogenic in animals and seem to be distributed in all countries, both rich and poor. in the third group are the 'neglected zoonotic diseases'. they are zoonotic diseases which have been eradicated (or drastically reduced) in affluent economies through vaccination and culling policies, and through introduction of hygienic and animal biosafety management practices. however, in many poor settings these diseases are 'neglected diseases' and receive very little attention from national authorities or even international organizations. this group includes brucella, bovine tb (tuberculosis), i.e. mycobacterium bovis, and many parasitic diseases, e.g. leishmaniasis and cysticercosis. in addition to these traditional infectious diseases there is a new threat of antimicrobial resistant (amr) bacteria. caused by the use of antimicrobials both in human and veterinary medicine this problem has emerged and is now to be recognized as one of the most important threats to human health. although in the detail the control of these groups of diseases differ, they are all most efficiently prevented by a one health approach which considers the full farm-to-fork chain. such preventive and holistic approaches may reduce both the disease burden to human health and the economic burden to developing economies, and therefore represent a significant potential for improvement related to food safety as seen in a one health perspective. through food and feed, direct contact, and via the environment, the human-and the animal microbial flora are in contact with each other. figure . outlines the most important routes of transmission for infectious diseases between humans and animals. via these routes infectious diseases from (food-)animals may enter the human reservoir and vice versa. the foodborne transmission route is probably the most important gateway for this contact, and the vast majority of human infections with enteric zoonotic bacterial pathogens, such as salmonella enterica, campylobacter coli/jejuni, and yersinia enterocolitica, occur through this route. for other diseases there is evidence that transmission also occurs via direct contact between (food) animal and humans, e.g. live-stock associated methicillin resistant staphlylococcus aureus (mrsa) (graveland et al. ) . next, there is transmission via the environment (e.g. surface water or water used to irrigate plants) mainly as a result of spreading of manure into the environment (spencer and guan ; hutchison et al. ) . and though much less frequently reported, there may be transmission of pathogens from humans to animals, which most probably was the meat/milk/eggs etc. direct contact and products (eg.skin) veterinary medicine food & consumer authorities food environment indirect contact via water/air (faeces / urine / corpses) fig. . schematic presentation of important microbial transmission routes via which the human and (food) animals are in contact with each other. in blue control mechanisms are shown, and in red some of the transmission routes that are more difficult to control. via the environment transmission may take place of microorganisms present in excretion products, and in diseased animals and people. in addition, wildlife constitutes a risk, as it holds a broad spectrum of diseases, including many highly pathogenic diseases case for the staphylococcus aureus cc (price et al. ) . in many developing countries, wildlife forms an additional important reservoir for foodborne pathogens, not only through consumption of wildlife. because of often lower bio-safety levels in these countries, direct contact between humans and food animals is generally more frequent, and diseases from the wildlife community may cross over more easily to domestic animals. for instance, the general understanding now is that the sars epidemic in originated in direct human contact with and/or consumption of wildlife, or indirectly through contact between wildlife and domestic animals (guan et al. ; shi and hu ) . wildlife holds a broad spectrum of diseases including some of the most feared, such as ebola, rabies and anthrax and, and in contrast to other food sources, much of the consumption of wildlife goes undetected by food controlling agencies. for these reasons, and because of the global trade in wildlife derived food and other items (pavlin et al. ), consumption of wildlife animals, and the spillover of infectious diseases from wildlife to food/production animals, should not be overlooked. the spread of foodborne zoonoses through the food production chain is often referred to as the 'farm-to-fork ' (or 'farm-to-table' or 'boat-to-throat') chain. it should be noted that risk mitigation solutions under this framework typically have focused on a consideration of the full food production continuum, involving all relevant stakeholders, i.e. a typical one health framework invented before the one health paradigm was defined. figure . tries to capture a generalized picture of a farm-to-fork chain, starting with animal feed and ending in human consumption of animal food products. although a number of very important zoonoses are related to wildlife-and in some cases directly transmitted from wildlife animals-the vast majority of zoonotic disease cases in the world relate to animals that are bred for food purposes. such zoonotic pathogens include bacteria such as brucella, salmonella, campylobacter, verotoxigenic escherichia coli and leptospira; parasites, such as taenia, echinococcus and trichinella; and viruses, such as influenza a h n (avian influenza) and rift valley fever virus. next to these infectious diseases, derived agents such as (microbial) toxins and prions (prusiner ) form another important zoonotic subgroup. diseases originating on the farm can in many cases most efficiently be dealt with on the farm itself, thereby eliminating more complex measures or crosscontamination down the farm-to-fork chain. for example, brucellosis in animals (mainly cattle, sheep and goats) has been eliminated in many countries, thereby virtually eliminating the human disease burden (godfroid and käsbohrer ) . also, some of the main parasites can be effectively controlled at the farm level, and this could work for both taenia solium in pigs (defined by who/fao/oie as a 'potentially eradicable parasite'), as well as, trichinella spiralis which is found in many wild animals and importantly in pigs for human consumption. both parasites have essentially been eliminated from farmed pigs in most northern european countries (who/fao/oie ; gottstein et al. ). however, both diseases still form a serious 'neglected diseases' threat in settings where there is potential for contact between wild and domestic animals. it was primarily the outbreaks of sars and zoonotic influenza, amr (dealt with separately) and bse (bovine spongiform encephalopathy) which alerted the world to the need for a one health approach. outbreaks of viral diseases in humans, originating in or spreading through farm animals (avian flu-h n and swine flu-h n ) have caused major global alerts in the last decade. these influenza outbreaks spread very quickly, either in the animal population (h n ) or directly in the human population (h n ), and formed a global threat for human health. h n was therefore characterized by the world health organization (who) as a pandemic. although in total the human disease burden related to the endemic bacterial zoonoses is probably many fold higher than these influenza outbreaks, it is basically these relatively few but fast spreading outbreaks that have put one health on the global agenda. in addition, the failure to predict, monitor and control the spread of these diseases in animals presented regulators and politicians with a wake-up call, and made them demand (better) cross-sectoral collaboration between the animal and human health sectors. prions, non-living infectious agents, have been a significant burden of disease in animal and man. the most well-known zoonotic prion disease is probably the one causing bovine spongiform encephalopathy (bse) in cows, and new variant creutzfeldt-jakob disease in humans, as represented by the massive outbreak of 'mad cow disease' in the uk in the s and s. this agent, a mutant protein, which mainly sits in the brain, got into the (beef) food chain by the feeding of ruminant derived meat and bone meal to ruminants. prions (prusiner ) , scrapie (the disease in goats), spongiform encephalopathy of rocky mountain elk, transmissible mink encephalopathy, kuru and creutzfeldt-jakob disease were known before the large outbreak of bovine spongiform encephalopathy in the uk. it, however, took some time and great efforts, and an early one health approach, to establish the links between the different animal diseases and the human disease (hill et al. ; prusiner ; ghani et al. ). this insight created a background to efficiently stop the spread of this prion disease, by banning the use of animals in animal feed, and seeing a subsequent decrease of the disease in humans (hoinville ) . in the western world prion diseases have attracted much attention, and their control has resulted in a large economic burden to society. in developing countries, often with less strict rules about the re-use of dead animals, and more direct contact with wildlife, prion diseases may still be endemic though unrecognized. in contrast to the dramatic outbreaks discussed above, many food-related zoonoses are endemic in farm animals and some of the most important of these do actually cause disease in the animals. it should be realized that most countries-including most developing countries-produce large amounts of food animals, and most of the production takes place in some sort of industrialized setting. such settings are invariably linked to a number of important zoonotic pathogens. table . shows three lists of the most important food pathogens, as reported in studies published by the cdc in the usa and by rivm (havelaar et al. ) in the netherlands, as well as a list of pathogens recognized by ecdc as focus organisms for the eu. although widespread, these pathogens are often not recognized as important human pathogens because of their often mild disease syndromes in healthy persons (e.g. limited to diarrhea and vomiting) and because of the complexity of source attribution. however, they do form a serious threat to the vulnerable segments of our societies (i.e. the young, the elderly, the immune-compromised and recovering patients), and some patients may develop long-lasting chronic disorders (e.g. arthritis and neurological disorders) (mckenna ). these facts, together with the sheer number of infections they cause, results in a substantial total burden of disease for these pathogens as expressed in disability-adjusted life years (dalys) (see murray ) . for instance, the study of havelaar et al. ( ) showed that the total burden of the diseases he studied was , dalys, for a total of . million cases and deaths caused by these diseases (in million people). source attribution estimates showed that one-third could be attributed to foodborne transmission. similarly large numbers were reported for the usa (cdc ), where surveillance studies of known pathogens gave an estimated total of . million illnesses, , hospitalization and , deaths attributed to foodborne diseases (in million people). importantly, the latter report also showed that the pathogens studied make up only % of the foodborne diseases, and the majority of % is caused by unknown agents. this situation is probably not unique for the usa, and thus indicates that there is still much health to be gained from improved food safety. table . shows that an almost identical list of disability-adjusted life years (dalys), are a combined estimate of the burden of disease due to both death and morbidity. one daly can be thought of as year of healthy life lost and is often expressed in years of life lost on the population level, and can be thought of as a measure of the gap between current health status and an ideal situation where each individual in the population lives to old age, free from disease and disability (murray ) for the list of the cdc and the netherlands the ranking in terms of incidence, hospitalizations, deaths or daly is given. the list from ecdc was generated by expert consultation and for use as an eu focus list in future disease burden studies important foodborne pathogens are found in europe, and that toxoplasma gondii, listeria monocytogenes, campylobacter, rotaviruses, noroviruses and salmonella, should probably form the key targets for interventions. except for norovirus, these pathogens have been shown to be zoonotic, and find their way to humans via food and the environment ( fig. . ). a one health approach ensuring efficient crosssectoral collaboration and data-sharing, could lay the foundation for a realistic description of the situation, and could help implement sensible cross-sector solutions. building on the idea of one health to control these diseases, there are several countries (especially in northern europe and north america) that have instituted cross-sectoral data collection and collaboration. this is typically done through the construction of zoonosis centers or their equivalents. these centers aim to stimulate and facilitate the collaboration between human, veterinary and food institutes. some examples of such specialized centers are the us national center for emerging and zoonotic infectious diseases (http://www.cdc.gov/ncezid), the british national centre for zoonosis research (http://www.zoonosis.ac.uk/ zoonosis) and danish zoonosis centre which is part of the danish national food institute (http://www.food.dtu.dk/english/research/research_groups/zoonosis_ centre.aspx). two clear examples of what such centers can accomplish are: the reduction of salmonella in food animals in denmark, and the danish integrated approach to combat amr (described below in a separate section). in the danish salmonella reduction program, data sharing across animal, food and human health sectors has enabled science-based solutions, and has most noticeably resulted in significant reductions in human salmonellosis through lowering salmonella prevalence in animals (wegener et al. ) . in relation to laying hens the program started with a simple and inexpensive serological surveillance of egg producers. flocks found positive were either culled and repopulated, or used to produce heat-processed eggs, danish eggs are now considered free of salmonella. next to this arm, a program of surveillance and eradication of infected broiler flocks was setup. the effect of the whole program was measured in term of cases of human salmonellosis, which were found to be significantly reduced as the project progressed in time. the construction and solutions of this program clearly followed one health principles. food, veterinary and human health sciences worked together, using similar detection and (geno)typing techniques, which enabled comparison and sharing of data. this top-down selection of salmonella-free poultry could work in other countries with industrialized food animal production as well. in other countries-including most likely most developing countries, salmonella-positive animals have been imported from big producers in industrialized countries. one such documented example was the import into zimbabwe of salmonella enteritidis via live animals. salmonella entered the country through import of infected poultry in the commercial national production system around , and thereafter spread quickly to the communal sector (small-scale farming), as well as to the human population (matope et al. ). the most likely reason for the spread within zimbabwe was that old animals from the commercial sector were sold to small-scale communal production systems. as the trade of live animals is done on a global level and does not take into account whether the traded animals carry any of the diseases from table . , reducing the prevalence in the commercial sector in producing countries, may also lower the global spread and human disease burden in the rest of the world. the spectrum of neglected diseases is broad and includes diseases caused by bacteria, viruses and parasites. many are found world-wide but their prevalence in the human and animal populations varies according to the local agricultural, demographic and geographic conditions and tradition. for many of the neglected diseases solutions to dramatically decrease the disease burden are well-known, but action is lagging, this is the case for example for many of the parasitic zoonoses. this is the reason why the who refers to these diseases as 'neglected diseases' (who ; molyneux et al. ) . neglected diseases may be categorized into two (strongly overlapping) categories. in the first category are the neglected tropical diseases which include chagas disease, trypanosomiasis, leprosy, rabies, schistosomiasis and others, many of which are zoonotic and parasitic diseases. the second category are the neglected zoonotic diseases, covering many of the diseases above and also some bacterial diseases such as anthrax, bovine tuberculosis (tb), brucellosis, and also cysticercosis and echinococcosis. many of the neglected diseases are carried by wildlife and in poor and rural settings by livestock (e.g. brucellosis, anthrax, leptospirosis, q-fever and bovine tb). in addition, many are food-and waterborne (e.g. brucellosis, cysticercosis/ taeniasis and echinococcosis). in particular, the prevalence of bovine tb appears to be increasing in many poor settings and has been linked to hiv infections as an important factor for progression of a tb infection to an active tb disease (lobue et al. ) . brucellosis and bovine tb in cattle cause lowered productivity in the animal population, but seldom death, and both have largely been eradicated from the bovine population in the developed world by test-and-slaughter programs, which in effect has eliminated the human health problem (godfroid and käsbohrer ) . some of the parasitic diseases (e.g. schistosomiasis, cysticercosis, trematodiasis and echinococcosis) have high mortality rates and long-term sequelae including cancer and neurological disorders. cysticercosis is emerging as a serious public health and agricultural problem in poor settings (garcía et al. ) . humans acquire taenia solium tapeworms when eating raw or undercooked pork contaminated with cysticerci. the route of transmission is, pigs infected through taenia eggs shed in human faeces, and the disease is thus strongly associated with pigs raised under poor hygienic conditions. this means that the cycle of infection can be relatively easily broken by introducing efficient animal management, as has been done in most developed countries. given that % of the rural population in poor countries is dependent on livestock as working animals to survive (fao ) , the effect of these animals carrying a zoonotic disease can be dramatic, both relative to human health directly, but also as it affects the potential to earn an income. this also affects the potential mitigation action; for instance the large-scale culling of animals, which can be a viable solution in rich countries, might be problematic in the poorest countries. such solutions would not only mean loss of food, but also a serious socio-economic disruption, in some cases leading to national instability. some of the recent serious outbreaks of antibiotic resistant (amr) foodborne disease, such as ehec in germany (mellmann et al. ) , have shown us a new problem. there seems to be a global trend with the prevalence of amr rising (who ; danmap ; ecdc ; aarestrup ) . especially dangerous is the emergence of resistance against antimicrobials that are considered critically important in human medicine, and in multidrug resistant (mdr) infections (potron et al. ; kumarasamy et al. ). in the early s antibiotics were first introduced to control bacterial infections in humans. the success in humans led to their introduction in veterinary medicine in the s, where they were used in both production and companion animals. nowadays, antibiotics are also used with intensive fish farming and to control some infectious diseases in plants. their use is thus widespread. antibiotics in animals are mainly used in three ways: ( ) for therapy of individual cases, ( ) for disease prevention (prophylaxis) treating groups of animals, and ( ) as antibiotic growth promoters (agp) treating groups of healthy animals with sub-therapeutic concentrations to promote animal growth. when first introduced, the use of antibiotics led to improved animal health, and subsequently higher levels of both food safety and food security. all use, but in particular the use as agp, resulted in a dramatic rise in the use of antibiotics, and for instance, between and the use in the united states alone went from to , t (who ). however, the use of antibiotics in animals has over the years also resulted in a selective pressure for amr microorganisms, contributing significantly to the human health problem of amr bacteria. notably a number of bacterial strains that were previously susceptible to antibiotics are now in very high frequencies becoming resistant to various antibiotics, some of which are very important as last resort treatment potential for humans (bonten et al. ) . in particular the use as agp is questionable, as the concentrations used are sub-therapeutic which result in the selection for resistance but do not efficiently kill microorganisms. nowadays there are serious efforts by national authorities and some international organizations to reduce the antibiotic overuse in animals (food agricultural organization of the united nations (fao)/world organization for animal health (oie)/who ; who ; u.s. food and drug administration (fda) ( )), especially-but not only-through abolishing their use as agp. however, there seem to be major problems in ensuring cross-sectoral understanding, since the veterinary and medical professions are still in debate about how the amr problem has emerged (phillips et al. ; karp and engberg ; smith et al. ; price et al. ) . to achieve a science-based understanding of the problem, data on amr from both the animal and the human side should be compared, and both risk assessments and source attributions performed in an integrated way. in other words, a one health approach in which human and animal health sectors, including food and environmental sectors, work together, may help to deliver answers needed and suggest ways to reduce problems in both human and animal reservoirs (figs. . and . ). in addition to the factors described above, food production and food trade are now more and more global, and thus some of the food related problems are also global food problems. on the positive side, globalization has helped with some of the important global food issues: it raised food security, made our food more varied and tastier, and even including transport costs in the equation, still has global financial advantages. however, together with the food also the foodborne diseases now travel the globe. and if we do not stay on top of the problem, disease outbreaks might affect large parts of the global food sector negatively, in the end leading to negative health-but will also have financial and socio-economical consequences. a more holistic and pro-active approach to food safety may help prevent future food disasters and build healthy economies. one health approaches to combat zoonotic foodborne diseases need to consider at least three levels, the international level, national level and the farm level where the actual production takes place. to facilitate the work at all these levels, many countries have established specialized zoonosis centers. these centers focus their work on zoonotic diseases and promote collaboration between different sectors, and between different countries. they examine the prevalence of zoonotic diseases in humans and (food-)animals, their routes of transmission, the risk associated with their presence in our food chain, and the relation between human disease and zoonotic transmission. in addition, as our food production system has become increasingly dependent on global trade, the approaches taken by these zoonoses centers (should) also include a global angle. national zoonosis centers may also help tackle the global problems associated with zoonotic diseases. however, at the moment most of this work is done by international and global organization, such as the who, oie, and fao. these three international organizations have recognized that combating zoonoses is best achieved via a one health approach, as stated in their seminal paper 'a tripartite concept note' (fao/oie/who ), in which they express the need to collaborate for a common vision. given the impact zoonotic diseases have in socio-economical terms and on the vulnerable sectors in our societies, a one health vision is also endorsed by the world bank and the united nations children's fund (unicef) (world bank/who/unicef/oie/fao/unsic ). in their common vision, they say that a one health approach may lead to novel and improved solutions, including solutions that have not been considered before because of the high costs involved. for instance, while in some cases vaccination is the ultimate tool to prevent disease, it is not always considered because the costs of mass vaccination are higher than the public health benefit savings, or because of global trade regulations. under a one health approach sharing of costs, as well as other mitigation strategies could likely enable novel ways of reaching sensible solutions (narrod et al. ) . for global infectious disease safety national authorities report to who important outbreaks of human disease which have the potential of cross-border spread, under the auspices of the international health regulations (ihr) (who ) . these regulations also cover foodborne diseases associated with globally traded food. however, given the major impact that such announcements may have on global food trade, such as was the case with bse in the uk or the more recent trade barriers put up after the ehec outbreak in germany, national authorities may have become more careful and restricted in what they report. a global one health approach which both considers human health aspects and socio-economic consequences would therefore be a welcome improvement to the ihr of . next to who, other organizations are active in reporting global infectious disease outbreaks, most notably promed-mail (http://www.promedmail. org), which is an internet based program for monitoring emerging diseases worldwide, set up by the international society for infectious diseases. the program is dedicated to rapid global dissemination of information on outbreaks of infectious diseases and acute exposures to toxins that affect human health, including those in animals and in plants grown for food or animal feed, and thereby supports the one health principles. many of the (international) organizations and governing bodies named above have generated guidelines to control -and disseminate information about-food related zoonoses, such as for instance who's global foodborne infections network (gfn) (www.who.int/gfn), the european food safety authority (efsa) (www.efsa.europa.eu/en/topics/topic/zoonoticdiseases), foodnet from the us centers for disease control and prevention (www.cdc.gov/foodnet) and others. the goal of these networks is essentially the same: to help capacity-building and promote integrated, laboratory based surveillance and intersectional collaboration among human health, veterinary and food-related disciplines to reduce the risk of foodborne infections. the emergence of amr in food animals is a serious threat for modern human medicine. the risks exist that both (i) the overuse by mass prophylaxis and agp in animals, and (ii) the misuse of human critically important antibiotics in animals, will lead to the emergence of new amr organisms which may spread to the human reservoir, and via global food trade spread around the world. in the most critical scenario this will make our arsenal of antibiotics unfit to treat previously treatable infectious disease, and it might take us back to a situation as before world war ii, when antibiotics were not yet used in human medicine. one health principles may help mitigate this risk and deal with the amr problem in an efficient way. collaboration between the fao/who codex alimentarius commission and the oie have generated important guidance on how an integrated approach and the prudent use of antimicrobials may reduce the emergence of amr in (food-)animals and subsequently in humans. previous to this, in the who published the 'global principles for the containment of antimicrobial resistance in animals intended for food' (who ) which all countries should follow to reduce the risk of amr. the three major principles are: • use of antimicrobials for prevention of disease can only be justified where it can be shown that a particular disease is present on the premises or is likely to occur. the routine prophylactic use of antimicrobials should never be a substitute for good animal health management. • prophylactic use of antimicrobials in control programs should be regularly assessed for effectiveness and whether use can be reduced or stopped. efforts to prevent disease should continuously be in place aiming at reducing the need for the prophylactic use of antimicrobials. • use of antimicrobial growth promoters that belong to classes of antimicrobial agents used (or submitted for approval) in humans and animals should be terminated or rapidly phased-out in the absence of risk-based evaluations. these global principles have been supplemented with, ( ) guidance on the prudent use of antibiotics from the codex alimentarius commission together with oie, and ( ) six priority recommendations from who to reduce the overuse of antibiotics in food animals for the protection of human health (who ), being: ( ) require obligatory prescriptions for all antibiotics used for disease control in (food) animals; ( ) in the absence of a public health safety evaluation, terminate or rapidly phase out the use of antibiotics for growth promotion if they are also used for treatment of humans; ( ) create national systems to monitor antibiotic use in food-animals; ( ) introduce pre-licensing safety evaluation of antibiotics [intended for use in food animals] with consideration of potential resistance to human drugs; ( ) monitor resistance to identify emerging health problems and take timely corrective actions to protect human health; ( ) develop guidelines for veterinarians to reduce overuse and misuse of antibiotics in food animals. a recent publication (who ) covers the broader scope of amr in relation to both animals and humans. thus, a 'one health' approach has explicitly been proposed by these international organizations to mitigate the risk of amr. since the occurrence of amr in the food production sector, different programs to contain zoonoses and amr zoonoses have been developed following these principles and guidelines. the danish program to contain amr zoonoses, danmap, has in particular gained international attention and has been analyzed in different publications (who ; hammerum et al. ; aarestrup et al. ) . the reason for this was the early one health approach that the danish government and stakeholders proposed to combat amr. in , after publication of the finding that % of enterococci in all industrial produced chickens in denmark were highly resistant to vancomycin (a last resort drug for human therapy) the government decided that actions had to be taken (wegener et al. ) and set up the danish integrated antimicrobial resistance monitoring and research program (danmap). figure . shows the organization of danmap and how the animal health, food safety and public health sectors work together. the objectives of danmap are: ( ) to quantitatively monitor the consumption of antimicrobials used in (food) animals and humans, ( ) to quantitatively monitor the occurrence of amr in (zoonotic) bacteria in animals, food and humans, ( ) to study and describe the associations between antimicrobial consumption and antimicrobial resistance, and ( ) to identify routes of transmission and areas for further research. next to this an automated/ict program, called vetstat, was introduced to collect quantitative data on all prescribed medicine for animals from veterinarians, pharmacies and feed mills (stege et al. ) . vetstat data on drug usage proved important for understanding the different aspects of the antibiotic usage problem, and to provide tools to control the use. for instance, with the information from vetstat it has been possible for the danish veterinary and food authority (dvfa) to introduce "the yellow card initiative" (dvfa ) . this initiative works similarly to that in football, and farmers and veterinarians get a yellow card when their antimicrobial use is excessive as compared to similar farms. only by reducing the antibiotic use, which may be done for instance by adopting management practices from low users, the card can be retracted. this has not only worked as a stick, it also gives the farmers a sense of how they are doing compared to their colleagues. in the european union several countries have now also started to collect antibiotic usage data and to compare antibiotic use at country level (ema ). surveillance of foodborne infections, and infectious diseases in general, is important to understand the transmission of infectious diseases and identify risks. to do this efficiently data collection should be done in a harmonized way, so data can be compared and integrated. until now, this has been difficult because different human medical, veterinary medical, food and environmental laboratories have been using different techniques for surveillance, making it often almost impossible to compare data. with the introduction of whole genome sequencing (wgs) this problem may be solved. its unbiased way of detecting dna and its single platform (the dna code) for comparing genomic information gives wgs the potential to take disease diagnostics to a new level. some early uses showing the value of wgs for diagnostic and epidemiological purposes were the tracking of the massive cholera outbreak in haiti in (hendriksen et al. ) and by the ehec outbreak that was first detected in germany and later also found in other countries and which could be traced back to egyptian imported fenugreek seed using wgs (mellman et al. ). following up on these successes, an international group of scientists with representatives from oie, who, ec, usfda, us cdc, ecdc, universities and public health institutes, came together in brussels, september , to further discuss the possibilities of using wgs on a larger scale. their simple conclusion was that the technology to use wgs for diagnostic purposes is available, and its potential high, however, to make efficient use of the data, a global genomic database is needed (kupferschmidt ; aarestrup et al. ). such a database should be open to, and supported by, scientists from all fields: human health, animal health, environmental health and food safety, and should include genomic data for all types of microorganisms as well as meta-data to trace back the source of the microorganism. building such a database depends on a global one health approach, and in a one health manner both human health as well as other sectors will benefit from it. an important aspect of pursuing this initiative is that it will not only be beneficial for the developed world, but it may especially be beneficial for developing countries. for them genomic identification will mean a giant leap forward as they do not need to implement the wide variety of specialized methods that are nowadays used in the developed world. if set up in a sensible, inclusive, open-source framework wgs analysis will provide the world with a strong weapon in the fight to combat infectious diseases in all sectors. one health approaches may be synergistic in controlling foodborne zoonotic diseases to support both sufficient food safety, and sustainable food security. clearly, because of the unique situation of transmissibility between humans and animals, zoonoses control relies on the control of the microorganisms in ( ) animals, ( ) the food chain and in ( ) humans. in addition, as zoonoses originate in animals before being transmitted to humans, the most effective interventions may be achieved at the source, i.e. at the farm. to be most effective, approaches to reduce the risk of foodborne zoonoses should include all stakeholders from the human as well as the animal health side. at the transmission level, it will be of major importance to involve food and consumers authorities and related stakeholders (e.g. environmental specialist), to make sure the spillover from the animal reservoir is kept as low as possible. the exact solution will differ per country and type of disease (e.g. in many developing countries neglected diseases may still be of importance). given that % of the rural population in poor countries is still dependent on livestock as working animals to survive, the effect of these animals carrying a zoonosis will work out differently than in the industrialized settings. a number of the most important zoonoses relate directly to food production systems in poor settings which could be reduced dramatically through well-known interventions, such as has been the case for brucella, bovine tb and cysticercosis. furthermore, it is important to realize that much of the one health efforts until now have focused on zoonotic pathogens with a potential for dramatic global spread (such as avian influenza and bse). however, major health gains can be obtained with the endemic zoonotic pathogens. for instance salmonella causes a dramatic global disease burden because of the sheer number of cases and the global spread via food and live animal trade. for salmonella there are efficient methods to reduce the prevalence in food animals. one health approaches in the food sector are complex and involve both public and commercial stakeholders, which may put limitations on what can be done. on the one hand food should be nutritious and adding to one's health. on the other hand most food is commercially produced and traded. as food is a commercial product, one of the ways to make food producers (the supply-side) produce more healthy food, is if the public demands this (the supply-demand balance). therefore, educating the public to buy healthier food may be a way to make food manufacturers produce healthier food. next, there are other stakeholders and fields of science (e.g. industrial sciences or logistics) and policy (e.g. economics) that contribute to the food chain, but which may focus on other aspects than healthy food alone, and their conclusions may conflict with the food safety principles (e.g. the use of agp to improve animal growth). clearly food safety is a complex issue, and integration of all its problems and data is difficult and should best be limited to its essential components. for this reason, countries should learn from experiences abroad that have documented success. there are many examples of one health approaches that have helped lower the risk of zoonotic foodborne disease. key to all approaches has been surveillance of the farm-to-fork chain. surveillance should be done at relevant levels of the chain, at the farm level by the veterinary system, and at the food production stage by food-scientist. findings should be shared and compared with the findings in human medicine, to be able to make decisions about potential risks for human health. thus the animal, food and human sectors need working together, to collect and to share data in such a way that they may be compared. as there are still many different techniques used in all three fields, it is still difficult to compare data. an important development in infectious disease diagnostics will be the introduction of wgs techniques, and the construction of a global, open-access genomic database for microorganisms. in a one health manner, the latter would take diagnostics to a new level, and will greatly improve human, animal and food safety. sustainable farming: get pigs off antibiotics changes in the use of antimicrobials and the effects on productivity of swine farms in denmark integrating genomebased informatics to modernize global disease monitoring, information sharing, and response vancomycin-resistant enterococci: why are they here, and where do they come from? cdc estimates of foodborne illness in the us the danish integrated antimicrobial resistance monitoring and research programme the yellow card initiative annual report of the european antimicrobial resistance surveillance network (ears-net) methodology protocol for estimating burden of communicable diseases trends in the sales of veterinary antimicrobial agents in nine european countries improved animal health for poverty reduction and sustainable livelihoods. fao animal production and health paper the fao-oie-who collaboration -a tripartite concept note food agricultural organization of the united nations (fao)/world organization for animal health (oie)/who ( ) joint fao/oie/who expert workshop on non-human antimicrobial usage and antimicrobial resistance: scientific assessment cysticercosis working group in peru. taenia solium cysticercosis epidemiological determinants of the pattern and magnitude of the vcjd epidemic in great britain brucellosis in the european union and norway at the turn of the twenty-first century epidemiology, diagnosis, treatment, and control of trichinellosis persistence of livestock associated mrsa cc in humans is dependent on intensity of animal contact isolation and characterization of viruses related to the sars coronavirus from animals in southern china danish integrated antimicrobial resistance monitoring and research program disease burden of foodborne pathogens in the netherlands population genetics of vibrio cholerae from nepal in : evidence on the origin of the haitian outbreak the same prion strain causes vcjd and bse decline in the incidence of bse in cattle born after the introduction of the 'feed ban' analyses of livestock production, waste storage, and pathogen levels and prevalences in farm manures comment on: does the use of antibiotics in food animals pose a risk to human health? a critical review of published data emergence of a new antibiotic resistance mechanism in india, pakistan, and the uk: a molecular, biological, and epidemiological study outbreak detectives embrace the genome era tuberculosis in humans and animals: an overview salmonella enteritidis in poultry: an emerging zoonosis in zimbabwe food poisoning's hidden legacy prospective genomic characterization of the german enterohemorrhagic escherichia coli o :h outbreak by rapid next generation sequencing technology zoonoses and marginalised infectious diseases of poverty: where do we stand? quantifying the burden of disease: the technical basis for disability adjusted life years a one health framework for estimating the economic costs of zoonotic diseases on society risk of importing zoonotic diseases through wildlife trade, united states does the use of antibiotics in food animals pose a risk to human health? a critical review of published data european dissemination of a single oxa- -producing klebsiella pneumoniae clone staphylococcus aureus cc : host adaptation and emergence of methicillin resistance in livestock prion diseases and the bse crisis a review of studies on animal reservoirs of the sars coronavirus agricultural antibiotics and human health public health implications related to spread of pathogens in manure from livestock and poultry operations vetstat-the danish system for surveillance of the veterinary use of drugs for production animals food and drug administration (fda) ( ) years of resistance who global principles for the containment of antimicrobial resistance in animals intended for food: report of a who consultation with the participation of the food and agriculture organization of the united nations and the office international des epizooties who global strategy for containment of antimicrobial resistance impacts of antimicrobial growth promoter termination in denmark. the who international review panel's evaluation of the termination of the use of antimicrobial growth promoters in denmark international health regulations neglected tropical diseases: hidden successes, emerging opportunities tackling antibiotic resistance from a food safety perspective in europe guidelines for the surveillance contributing to one world, one health: a strategic framework for reducing risks of infectious diseases at the animal-human-ecosystems interface key: cord- -mi gcfcw authors: davis, mark d m; stephenson, niamh; lohm, davina; waller, emily; flowers, paul title: beyond resistance: social factors in the general public response to pandemic influenza date: - - journal: bmc public health doi: . /s - - - sha: doc_id: cord_uid: mi gcfcw background: influencing the general public response to pandemics is a public health priority. there is a prevailing view, however, that the general public is resistant to communications on pandemic influenza and that behavioural responses to the / h n pandemic were not sufficient. using qualitative methods, this paper investigates how members of the general public respond to pandemic influenza and the hygiene, social isolation and other measures proposed by public health. going beyond the commonly deployed notion that the general public is resistant to public health communications, this paper examines how health individualism, gender and real world constraints enable and limit individual action. methods: in-depth interviews (n = ) and focus groups (ten focus groups; individuals) were conducted with community samples in melbourne, sydney and glasgow. participants were selected according to maximum variation sampling using purposive criteria, including: ) pregnancy in / ; ) chronic illness; ) aged years and over; ) no disclosed health problems. verbatim transcripts were subjected to inductive, thematic analysis. results: respondents did not express resistance to public health communications, but gave insight into how they interpreted and implemented guidance. an individualistic approach to pandemic risk predominated. the uptake of hygiene, social isolation and vaccine strategies was constrained by seeing oneself ‘at risk’ but not ‘a risk’ to others. gender norms shape how members of the general public enact hygiene and social isolation. other challenges pertained to over-reliance on perceived remoteness from risk, expectation of recovery from infection and practical constraints on the uptake of vaccination. conclusions: overall, respondents were engaged with public health advice regarding pandemic influenza, indicating that the idea of public resistance has limited explanatory power. public communications are endorsed, but challenges persist. individualistic approaches to pandemic risk inhibit acting for the benefit of others and may deepen divisions in the community according to health status. public communications on pandemics are mediated by gender norms that may overburden women and limit the action of men. social research on the public response to pandemics needs to focus on the social structures and real world settings and relationships that shape the action of individuals. conclusions: overall, respondents were engaged with public health advice regarding pandemic influenza, indicating that the idea of public resistance has limited explanatory power. public communications are endorsed, but challenges persist. individualistic approaches to pandemic risk inhibit acting for the benefit of others and may deepen divisions in the community according to health status. public communications on pandemics are mediated by gender norms that may overburden women and limit the action of men. social research on the public response to pandemics needs to focus on the social structures and real world settings and relationships that shape the action of individuals. the re-emergence of infectious diseases is a leading public health problem. pandemics and epidemics [ ] including avian influenza, sars, ebola, and pandemic influenzaand the rise of anti-microbial organisms [ ] now threaten the health of populations around the globe. it has been argued that the re-emergence of these diseases marks the end of the golden age of medicine and the dawning of a period where health and security will be undermined by resurgent infectious diseases [ ] . pandemic influenza stands out in this situation because: it spreads quickly around the globe affecting many millions of people; it is associated with, potentially, high mortality, and; the world experienced a highly publicised, though ultimately mild for most, pandemic influenza in / . it is believed that another, more serious influenza pandemic is inevitable, though no-one, as yet, can predict when it will occur. for these reasons, explaining infectious diseases threats to the general public and encouraging them to adapt their health behaviours is high on the public health agenda. in relation to pandemic influenza, public communications feature in preparedness and response planning which requires that members of the general public adopt measures during a public health emergency, including: hygiene (e.g., covering the mouth and nose when sneezing or coughing, washing hands, keeping surfaces clean, avoiding sharing personal items) and the avoidance of close contact with others [ ] . understanding how populations respond is also crucial for the science that supports response planning. for example, mathematical models, which underpin pandemic response planning, factor in biological, psychological and sociological assumptions of how populations respond to infectious diseases [ , ] . effective communications with the general public and understanding how they respond, therefore, have a pivotal role to play in the management of pandemic influenza, in particular, and in the area of emerging infectious diseases, in general. however, knowledge of how to best communicate on pandemics with the general public and how they take up these messages is an emerging field with some inconsistencies [ ] . evaluations of the public health response to the / pandemic influenza claim that public communications were largely successful in preparing and reassuring publics during the emergency [ , ] . these findings need to be read against the fact that the pandemic was a short-lived and ultimately mild public health emergency for most people. there is a view, also, that members of the general public are resistant to pandemic risk messages. some commentary has suggested that the general population is increasingly resistant to public policy on global threats, including climate change and emerging infectious diseases [ ] . surveyswhich dominate the social scientific view on public responsesconducted during the pandemic indicate that populations in the uk and australia were complacent with regard to h n and reported insufficient behavioural responses [ ] [ ] [ ] [ ] [ ] . broad brush, risk communication research has identified that material circumstances and symbolic framing of risk [ ] , inequalities in education and access to media [ ] , (mis)trust in media and governmental advice [ , ] , all shape how members of the general public respond to communications on pandemics. close-focus, qualitative research offers the view that while the general public endorses governmental advice, in the circumstances of the / pandemic they were also unlikely to act in the ways advised by governments [ , ] . there are additional explanations for the apparent resistance on the part of the general public. for example, because they are bombarded with so many messages, including those pertaining to pandemics, members of the general public may by subject to 'health threat fatigue' [ ] . this is not the same as resistance. it is, instead, a dulling of alertness seated in screening out of overwhelming and competing risk messages. members of the general public appear to digest and critically reflect on risk communications messages [ ] , and tailor risk reduction strategies to their personal circumstances [ ] . it is also argued that the general public is only too aware of the 'boy who cried wolf ' syndrome [ ] , where too frequent assertion of danger leads publics to dismiss public health warnings. in addition, audience reception of communications on health is framed by the historic rise of individualism in society [ ] and health systems [ ] . individualism implies that members of the general public take on the view that responsibility for their health is a matter of personal volition and effort. this view is often utilised in health communications that call on people to take care of themselves, but it is a perspective that can obscure factors that are not within the control of the individual. it is also an approach to risk that has a moral loading and therefore a negative effect for those who are unablethrough choice or otherwiseto avoid health harms. exactly how individualism plays out in relation to pandemic influenza warrants further inquiry. because it is so vital that public health authorities communicate with members of the general public as effectively as possible and as there are competing explanations and routes of inquiry available in the literature, it is necessary to re-examine the apparent resistance to communications and advice on the part of the general public. a central challenge is to get beyond prevailing assumptions and build up a theory of public engagement informed by the life worlds of the general public [ ] . understanding why populations fail to sufficiently enact precautions must involve taking account of how lives are lived and the meanings ascribed to the threat of infectious diseases. indeed, what might look like lack of precaution may turn out to be reasonable given the material and symbolic circumstances of affected individuals and populations. a related challenge, then, is re-examining how public health characterises the general public in research on pandemics and in the more general area of emerging infectious diseases. taking these steps is vital to ensure that the public health response and its communications with the general public are as resonant, meaningful and effective as possible. this paper, therefore, uses inductive, qualitative research methods to develop new knowledge on how members of the general population respond to pandemic influenza, set against the backdrop of the assumed resistance on the part of the general public and related critiques, including, health risk fatigue, the risk communication dilemma and individualism. the analysis poses the question: how do members of the general public respond to the threat of pandemic influenza and to the hygiene, social isolation and other measures proposed by public health? by addressing this question in the manner indicated, the paper offers an alternative framing of pandemic influenza perceptions and behaviours in an effort to contribute to the better health of individuals and populations facing risk of infectious diseases. the following analysis was generated in international research (australian research council discovery project dp ) focusing on the responses of members of the general public to the events of alongside interviews with researchers, clinicians and policy-makers [ , ] and analyses of the public policy texts on pandemic influenza control [ ] . this research has examined general public data in light of sociological and psychological perspectives on responses to pandemic influenza [ , [ ] [ ] [ ] [ ] . the present paper synthesises and builds on the research undertaken on the general public, in particular, and introduces new data analysis to address the public health challenge of effective communication and engagement with members of the general public. interview and focus group participants were recruited through community sampling in melbourne, sydney and glasgow. generating data in australia and scotland addressed the international dimension of pandemic influenza and the events of . australia was closely observed by other nations as early stages of the global pandemic in coincided with the southern hemisphere influenza season. the pandemic quickly affected melbourne, which reported a high and early peak of known infections [ , ] . the city, for a time was known as the 'flu capital of the world.' the first confirmed cases in the uk were in scotland among passengers on a flight from mexico to glasgow [ ] . the uk and australia reported [ ] and [ ] deaths, respectively, associated with the h n pandemic. our analysis of interview and focus group texts reveals more convergence than difference between melbourne, sydney and glasgow, perhaps because the pandemic was managed in those cities by public health professionals who were members of a global pandemic response network. the research aimed to identify how members of the general public respond to pandemic influenza so that public health communications can be designed to engage with how its audiences respond to risk messages and how they enact hygiene, social isolation and related measures. four purposive criteria were used to select respondents in each city: women who were pregnant during (or with a new baby); older members of the community ( years of age and older); people with compromised immune systems and or respiratory illness such as asthma; and people who self-identified as being 'healthy' (e.g., no disclosed health problems) and who did not belong to one of the former categories. in addition, selection of participants was conducted to ensure: a balance of male and female participants and a range of ages from years upwards. drawing on interviews and focus groups ensured depth and breadth. interviews explored in-depth discussion of personal experiences of living through the h n pandemic, seasonal influenza and related concerns. focus groups examined social norms concerning precautionary behaviours regarding pandemic influenza. between april and may , people participated in the research (see table ) in interviews and ten focus groups (with participants). interviews included people from the purposive criteria (pregnant = ; + = ; hiv/respiratory illness = ; healthy = ); a gender mix (women = ; men = ), and; an age range of to + years. focus groups included people from the + group ( ); hiv/respiratory illness ( ) and the healthy group ( ); a gender mix (women = ; men = ), and; an age range of to + years. this pattern of participation reflects the challenges of recruiting women who were pregnant in , the very elderly and men. seven respondents reported having been diagnosed with h n ; none through a laboratory-confirmed test (a reflection of our community sampling). a further eleven interviewees reported that a relative, friend or other social contact had been diagnosed, clinically. it needs to be acknowledged, however, that, as influenza is not ordinarily diagnosed with a laboratory confirmed test [ ] , public health professionals and members of the general public identify and manage the infection on the basis of symptoms. indeed, respondents noted difficulty determining whether they had had influenza participants were asked to speak about their experiences with influenza and the public health response to the pandemic. topics for discussion included: health background (including pre-existing medical conditions, other infectious diseases, influenza vaccination); influenza experiences (including knowledge of pandemic influenza, sources of knowledge, experiences with the pandemic and seasonal influenza, prevention of infection, caring for self and/or someone else with infection); public communications (including broadcast and electronic media, public health advice, advice from gps, workplace and schools). verbatim transcripts of interviews and focus groups were analysed using an inductive, theory-building method. all transcripts were open coded to generate themes for analysis. interpretive memoranda were generated which explained each theme and how it connected with existing perspectives on the general public response to pandemic influenza. the research team reviewed these themes and memoranda to ensure that the themes were understood and that they could withstand refutation. this discussion also provided the basis for an agreed coding scheme that was used to re-code all data. key themes were identified for subsequent, in-depth written analysis in the form of technical reports and draft manuscripts. our approach to coding, memo writing and in-depth analysis sustains a dialogue between theory (pre-existing categories derived from social science theory and the relevant literature) and data (inductively-derived themes). this approach avoids the traps of overly dataor theory-driven analysis and ensures that the research has relevance to the field. this paper, therefore, is based on in-depth, nuanced analysis of interview and focus group texts that offers new perspectives and propositions, which provide the basis for interrogating prevailing assumptions regarding the general public response to pandemic influenza. this approach is consistent with social inquiry of the highest standard [ ] . the assumed complacency and resistance on the part of members of the general public was not in evidence in the narratives provided by our research participants. other factors, centred around health individualism and contextual factors such as gender and biomedical situation do appear to influence how people respond to the threat of pandemic influenza. in what follows, we focus on themes that establish and complicate the role of health individualism and its effects in the responses of members of the general public to pandemic influenza. the interviews and focus groups revealed a tension to do with self and other in relation to the threat of pandemic influenza. as we have discussed elsewhere, respondents endorsed the pandemic control measures advocated by public health authorities [ ] . they agreed that hygiene control measures (coughing and sneezing etiquette) and social distancing were valuable. this endorsement held in australia and scotland. characteristically, however, respondents did not believe that pandemic influenza could be prevented in the long run. they believed that the influenza virus was easy to catch and that hygiene measures and social isolation were difficult given that social interaction was needed to sustain work, schooling, the family and daily life. for this reason, respondents focused on strengthening their immunity through, for example, taking vitamins and eating healthy food: i think if you're healthy, keep up your vitamins and eat the right foods, drink healthily, eat healthily and live healthily. exercise. you've got to do all those things. (heather, +, melbourne) this immunity boosting was seen as a prudent defence against the seemingly inevitable moment of exposure and a means of coping with infection when and if it occurred. importantly, this focus on one's body and immunity in the face of seemingly inevitable infection accentuated health individualism, encouraging members of the general public to focus on their body's abilities to resist and cope with infection. there was evidence that immune boosting has the status of a social norm as those who were seen to succumb to infection were sometimes judged as failing to adequately care for themselves, even though it was admitted that the virus was easy to catch. to some extent individualism is an asset for public health interventions that seek behaviour change at the individual level. however, an individualistic approach to pandemic risk may obscure factors that the individual cannot control and, as indicated by the judgement of those who acquired infection, health individualism may be moralising. health individualism was not the only factor influencing how members of the general public perceived risk for pandemic influenza and took action. respondents who had responsibilities for others (e.g., pregnant women, people in couples or caring for people with health problems, families with children) or who saw themselves as vulnerable to influenza (e.g., respiratory illness, immune disorders) focused on social units such as the couple, family and colleagues at work: well given that the flu broke out at xxxx street primary school and my son was three and he was at xxxx street childcare, i pulled him out. so when my husband picked him up that day i was at work. i said, 'take him home. give him a bath. wash his clothes.' yeah. i stopped sending him and i was one week off my maternity leave so i stopped work a week early … i didn't go to the supermarket, didn't really mix. (gill, pregnant, melbourne, - years) it appears, then, that both health individualism and relationships with important others influence what people do. in this regard, social proximity appears to be important, that is, those others who are close to oneself in terms of social and emotional ties and living situation are factored into health precautions. this social proximity also showed up in the ways in which respondents saw geographical distance and low population density as protective. those respondents living further away from the populous 'epicentres' of infectioncentral melbourne, for examplebelieved that they were less likely to encounter someone with the virus. ' we're familiar with chest infections' one important way in which this tension between responsibility to oneself and to others came to light in interviews and focus groups related to differences between the responses of those with pre-existing conditions and those who identified as 'healthy.' those who faced increased risk of serious disease focused on their relationships with othersincluding strangers they might encounter in public spaceslargely in an effort to protect themselves. those with no vulnerabilities showed themselves to be archetypally focused on their individual health. for example, people with severe respiratory illness reported that engagement with the risks of influenza was a 'well trodden path' for them: as lung patients, we're, we're familiar with chest infections and, as joy says, we could, we could have a flu and not know it. and the gp checks us over. and the only way that i know that they'll know whether it's a chest infection or flu, or pneumonia, is for an x-ray. (arthur, lung disease, melbourne, + years) people with pre-existing lung conditions, then, were commonly hyper-vigilant during the pandemic and their accounts were peppered with examples of how social interaction was imbued with risk for them and also some resentment that the healthy majority seemed to not understand the significant threat that influenza infection might pose to their health [ ] . people with immune disorders in our sampleprimarily hivunderstood they needed to be vigilant but saw influenza as a lower priority than their hiv infection and its effective management. older respondents ( +) conveyed judicious vigilance tempered with an unwillingness to be seen to overreact. important in these accounts was awareness of the vectors of transmission and that one's health was to some extent dependent on those with whom one interacted. in contrast, the healthy majority of our respondents saw pandemic influenza as a personal, though distant, health threat. they saw themselves 'at risk' and possibly as 'a risk' to close family, but not as 'a risk' to unknown others (e.g. a person sitting beside them on public transport). this focus on the 'at risk' self to the exclusion of the self as 'a risk' to others underlines how health individualism manifests in the responses of the 'healthy' majority of the general public. this focus of the healthy on their own health risks (at the expense of others) surfaced in narrative on expectations of recovery from influenza: like you sort of just, you think, maybe you just think influenza as a common cold sort of thing. and it's like, 'it'll pass. i might go to the doctor's and get some, something to help me get through it, ' or something. but yeah, i don't know … it's just like, 'just ignore it and push through.' (chris, healthy, melbourne, - years) this interview participant shows how a healthy individual engages with pandemic influenza as a commonplace and personal risk, in contrast to those with pre-existing conditions who have to take pandemic, and even seasonal, influenza seriously. this expectation that one can 'push through' reinforces the previous theme noted with regard to the focus on the capacity of one's body to deal with infection. it is also an orientation to influenza risk that sets the scene for individuals to determine that infection is a risk worth taking since recovery is likely. also, recovery expectations synergise with the belief that infection is difficult to avoid in the long run. this means that people may assume that, while non-pharmaceutical strategies of pandemic control are sensible, their limited utility is set against the likelihood of recovery. this nexus of risk calculation helps explain why segments of populations appear to be complacent in surveys, as noted above. they may in fact be making multi-layered risk assessments of the likelihood of infection, their health status and expectations of recovery. another important provision on health individualism was the gendered meanings of one's response to infection. particularly in domestic settings, the management of respiratory illness was largely feminised. women provided elaborate accounts of managing the respiratory infections of family members while men did not. importantly, the pejorative term 'man flu' was used to denote the over-inflation of mild symptoms to gain sympathy and respite from normal activities, with connotations of questionable masculinity: it's always a little difficult to tell when you're moving from, sort of, a cold through the man flu to proper influenza. (vincent, healthy, sydney, - years) these findings imply that responses to pandemic influenza in real world settings areas with other health problemsassociated with gender roles which shape behaviour, for example, women may be expected to perform infection control and symptom management, while men are expected to not show their symptoms and 'soldier on' or face accusations of 'man flu.' the uniform implementation of social distancing and other protective measures may therefore be compromised. accentuating the role of gender in response to messages concerning pandemic influenza, pregnant women found themselves thrust into a position of particular risk during the / pandemic, at a time when they were already taking responsibility for the well-being of their unborn child. in particular, the prospect of vaccination elicited varied, often emotion-laden, responses: well, (sigh) when you're pregnant everything is about the baby … you just want to try and make your baby as healthy as possible and you want to try and keep your baby safe. (rebecca, pregnant in , glasgow, - years) the imperatives of good motherhood and responsibility for their unborn children placed these women into the emotionally-charged position of having to make decisions regarding virus protection in circumstances of intense uncertainty [ ] . some distress was apparent among the pregnant women respondents, but also great resilience and active use of public policy information to protect themselves and their babies. as rebecca's account, above, indicates, health individualism in tension with responsibilities to others, gender and one's life situation played out in engagements with vaccination. though recollection was variable, respondents in the present research ( %) reported that they had had an influenza vaccination at some point in their lifetime and there was no evidence of 'in principle' resistance to vaccination. this is a notable finding given that participants were sought in community settingswhere those with anti-vaccine views are thought to be locatedand in light of commentary that members of the general public are resistant to the science and technology used to manage global threats. indeed, endorsement of public health measures and attempted compliance characterised the respondents' accounts, with the provisos on the practical value of non-pharmaceutical strategies of infection control and management, as already discussed. but, taking on vaccination was not always straightforward: i saw in the press releases about the vaccine and i remember ringing the clinic and they said,'well if we were to give it to you, you'd have to come to the hospital and that's gonna put you at risk of getting exposed to it so we'd rather you not come in for the, for the vaccine.' and i was thinking,'well that's a bit of a catch importantly, though, vaccination, like non-pharmaceutical infection control, was mostly discussed as a personal strategy of health protection. apart from those with pre-existing vulnerabilities, vaccination was not readily understood as a method for protecting others and therefore society. this individualistic focus on one's own health implies that efforts to promote 'herd immunity' may not accord with perceptions and behaviours of the healthy majority. the findings question the prevailing view that the general public resists risk communication with regard to pandemic influenza. nor do the related ideas of complacency and fatigue seem relevant. more salient was multi-layered risk management informed by health individualism and to some extent tempered by interpersonal responsibilities, one's personal circumstances, gender, expectations of recovery, and prior experiences with influenza. as others using qualitative methods have also suggested [ ] , respondents did not reject what was done by governments in . they show interest in pandemic influenza, though their mode of engagement with it varied. they indicated that they wished to be informed but reserved the right to interpret and apply advice according to their own situation. public health guidance on hygiene and social isolation was endorsed, though its utility was largely found to have practical, long-term limitations given that social interaction was fundamental to daily life and the transmission of the virus. resistance and the related notions of complacency and fatigue, then, appear to have limited value for explaining how members of the general public respond to pandemics. part of the reason for this inapt attribution of research results to public resistance concerns research approach. forced choice surveys produce measures of hypothesised variables thought to influence behaviour. in-depth interviews and focus groups yield a different picture, where general public perceptions of the dangers of pandemics are placed in the context of what appears to be endorsement of the efforts of public health, tempered with awareness of the practical difficulties of managing influenza on a local basis. personal experience narratives reveal members of the general public to be engaged and willing to apply guidance in real world settings, though also aware of limits on what might be possible in time of pandemic. going beyond the idea of resistance, our analysis offers an alternative framing of how members of the general public respond to pandemic influenza. health individualism complicated by life circumstances (family life, health status) and the gendering of the meanings and practices surrounding the experience of influenza and how to deal with it in real world settings, appear to be important. risk communications are likely to benefit by addressing these influences on risk management behaviours. in particular, emphasising individual responsibility in risk communication may amplify divisions between people with different biomedical vulnerabilities and encourage those who consider themselves healthy to think of themselves as 'at risk' but not 'a risk' to others. this is a major hurdle for public health, particularly when hygiene, social isolation and vaccination are likely to become more important methods for controlling the spread of re-emerging infectious diseases. the pejorative, gendered meanings of influenza, of which 'man flu' stands as exemplary, point towards the deeply inscribed gendering of responses to infectious diseases. the role of gender in social aspects of health care is no surprise, but fully-fledged gender analysis is yet to be acknowledged in the public health address to the general population with regard to pandemics. in particular, messages to enact hygiene and social isolation are likely to accentuate already feminised health care in the domestic sphere. further, it is not simply that women are burdened with the labour of influenza care and men not. if men do find themselves unwell they risk accusations of 'man flu' and may therefore avoid making themselves available for health care interventions, a dynamic which keeps men out of the gp clinic in general [ ] . as recent reviews have indicated [ , ] , the influences of social factors on responses to pandemics need to be foregrounded in the social research agenda for better public health. our research indicates that health individualism and gender need to be part of this new research agenda. our findings also point to several further, specific, challenges for risk communication: ideas of proximity to risk; expectations of recovery, and; vaccination. proximity appears to be a blind spot in risk communications. public health messages of emergency are filtered by perceptions of proximity to threat, consistent with psychological theory [ ] and cultural constructs where the source of contagion is placed at a distance from self [ ] . we found that these ideas of proximity did surface in the narratives of members of the general public. yet, we know that, for example, within six weeks of the infection being detected in australia, people in remote communities in australia were found to be infected [ ] . risk communication needs to attend to these ideas of distance from risk and the related underestimation of the speed with which the influenza virus can travel in a hyper-connected world. expectations of recovery from influenza also appear to dominate narratives. as others have argued [ ] , healthy respondents recognised influenza infection as severerequiring bed and restbut thought that they would eventually recover. this finding implies that members of the general public may interpret infection as a risk worth taking, that is, that they can cope with infection if prevention fails them, due to their own choices or otherwise. members of the general public appear to be actively engaged with manifold risks that they juggle and prioritise in real world settings. our findings also suggest that taking up vaccination is not a simple matter, even among those who endorse the use of the biotechnology. survey findings have found that approximately % of australians are concerned about general vaccine safety [ ] and that australian [ ] and worldwide [ ] rates of h n vaccination have been found to be insufficient, prompting concerns that the 'anti-vaccine lobby' and other detractors are influencing use of this biotechnology. as noted, a slight majority of our respondents reported that they had been vaccinated in their lifetime and none spoke of vaccination as dangerous, though, of course, some may have held these views and not revealed them or opted out of our community-based recruitment strategies. our research, however, points to more immediate and practical considerations that shape how and when people vaccinate, including considerations of relative risk and whether or not a new vaccine should be used in pregnancy. attending to these more immediate concerns may be beneficial for public health, though we acknowledge that public perception of vaccine technologies is also an important public health agenda. the analysis presented is retrospective as the interviews and focus groups were conducted after the end of the pandemic on august [ ] , and therefore when it was known that the mortality rate had at first been overestimated [ ] . importantly, too, the respondents were volunteers selected according to purposive criteria, implying that the sample is not representative and that generalisations to populations are not strictly tenable. what the analysis offers, however, is the opportunity to drill down into how people make sense of pandemic influenza, therefore providing the basis for building theory on how members of the general public, think, feel and act in the contemporary era of efforts to manage global health threats. the perspectives identified here help situate what we know in social context and alert public policy to some dilemmas and alternative explanations of why members of the general public do what they do. for public health to shape the actions people take prior to and during a pandemic, we need to understand and engage with the perspectives of those acting. viewed from the outside, the behaviour of the general public has been cast as resistant. however, viewed from the perspective of ordinary people involved in anticipating and responding to infection, it is clear that public health has engaged its publics. this engagement is frequently informed by individualistic ways of assessing and responding to risk, social norms (e.g. gender roles), knowledge of the clinical uncertainties of influenza infection, and reasoned thinking about the limits of preventing influenza transmission. the current challenge for pandemic influenza preparedness and response is not so much to address public disinterest, but to acknowledge and engage with members of the general publics' experiences of influenza and how they make sense of, and act on, pandemics in real world settings. factors in the emergence of infectious diseases antibiotic resistance: long-term solutions require action now world health organization. the world health report : a safer 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vaccination campaigns world health organization. h n in post-pandemic period: director general's opening statement a virtual press conference influenza a(h n ): lessons learned and preparedness submit your next manuscript to biomed central and take full advantage of: • convenient online submission • thorough peer review • no space constraints or color figure charges • immediate publication on acceptance • inclusion in pubmed, cas, scopus and google scholar • research which is freely available for redistribution submit your manuscript at www this research was funded by an australia research council discovery project grant (dp ) with additional funding from glasgow caledonian university. we are grateful to casimir macgregor for assisting with interviews and to everyone who agreed to participate in interviews and focus groups. the authors declare that they have no competing interests.authors' contributions md helped conceive of this research, drafted this manuscript, managed the data collection and analysis in melbourne and integration with all data, and is a grantholder. ns helped conceive of this research, contributed sociology of public health perspectives to the manuscript and edited it, managed data collection and analysis in sydney and integration with all data, and is a grantholder. dl collected and analysed data used in this paper, conducted a literature review used in this paper, and contributed to the draft manuscript. ew collected and analysed data used in this paper and contributed to the draft manuscript. pf helped conceive of this research, contributed health psychology perspectives to the manuscript and edited it, managed data collection and analysis in glasgow, and is a grantholder. all authors read and approved the final manuscript. key: cord- -ugc ce authors: ching, frank title: bird flu, sars and beyond date: - - journal: years of medicine in hong kong doi: . / - - - - _ sha: doc_id: cord_uid: ugc ce in the politically sensitive year of , hong kong experienced an outbreak of avian flu when the deadly h n virus unprecedentedly jumped the species barrier from chickens and infected human beings. hong kong decided to slaughter over a million chickens, and the virus was stopped in its tracks. in , hong kong was the epicenter of the sars pandemic, which originated in guangdong province. the faculty of medicine played key roles in both instances, with its microbiology department successfully identifying a novel coronavirus as being responsible for sars. hong kong learned from its experience and took action to combat the emergence of new infectious diseases. such vigilance paid off in , when swine flu swept the world, and in , when a novel avian flu h n emerged in china. all the preparations to entrench medical autonomy in hong kong after the british departure did little to help the freshly minted hong kong special administrative region deal with the first medical emergency in the post-colonial period: an outbreak of what was widely called the bird flu, which for the first time saw the virus jump the species barrier to infect human beings, sickening people, of whom six died, an inordinately high mortality rate of %. hong kong gained the distinction of being the only place where this event, which scientists had thought could not happen, actually happened. it was previously thought that avian influenza viruses could not directly attack humans, requiring a mammalian intermediary such as a pig, wherein host adaptation or genetic reassortment could take place, before a virus capable of infecting humans would emerge. that was thought to have been the pattern of previous pandemics, such as the asian flu of and the hong kong flu of , which together claimed more than . million human lives. as for the great flu of , which infected an estimated million people worldwide-about a third of the world's population at the time-and killed - million people-there is still no agreement on its origins, although the u.s. surgeon general alluded to an asian origin saying, "some writers who have studied the question believe that the epidemic came from the orient." in march, , the first signs of trouble in hong kong appeared when chickens on a yuen long farm started to die. then those on a second farm started dying, and a third, with about , birds succumbing to influenza. although farmers were concerned, health authorities were not too worried because the virus from which the chickens suffered was never known to cross the species barrier and infect humans. that is, not until two months later. to coordinate, and to articulate to the public what is going on," fukuda said. "meet public expectations and marshal all scientific expertise you need. make sure agriculture was involved. dr. margaret chan was clearly overseeing everything." shortridge himself felt subsequent events justified the cull. "the last human case of h n disease was recognized the day before the commencement of the slaughter on december, vindicating the controversial slaughter policy," he wrote. "it is reasonable to believe that this intervention prevented an incipient pandemic progressing to an actual pandemic and thus a pandemic was averted. the h n / virus was possibly one or two mutational events from achieving pandemicity. however, as with all measures that successfully prevent an adverse outcome there is no definite way of proving their efficacy." the unusual clinical severity and high mortality of infected patients in the outbreak of avian influenza h n in hong kong was first reported in the lancet in february by yuen kwok-yung (k.y. yuen) of hong kong university's department of microbiology. he was the lead writer, whose co-authors included k.f. shortridge and malik peiris. yuen had attended to h n patients and devised a rapid diagnostic test known as rt-pcr used in testing the respiratory secretions from these patients. this was the first time that the test was used for rapid diagnosis of such patients in a clinical setting. he also analyzed the case notes of patients, ranging in age from to . "whether avian viruses can infect human beings directly or need to reassort in an intermediate host (e.g., pigs) is a matter of debate," he wrote, adding: "until recently, a purely avian virus had not been isolated from people with respiratory disease, although conjunctivitis caused by an avian h virus has been reported." while decisions regarding the slaughter of chickens were made by the government, the university played a major role. this was known to the outside world as well. thus, the following year, when thailand announced the winner of the prince mahidol award for outstanding achievements in medicine and public health, the award was shared jointly by margaret chan, the director of health, and professor shortridge. in the aftermath of the events, tight surveillance of the live poultry retail markets revealed that the highly pathogenic h n / virus was no longer detected. however, the precursor viruses remained, including the h n -like virus in the guangdong goose identified in and other viruses in quails. live chickens continued to be sold in hong kong but the government after instituted a policy of central slaughter of geese and ducks. for three years, hong kong's retail markets remained free of the h n virus. but in , the h n virus was back. on april , the government announced that it had isolated goose/ -like h n virus from a chicken cage in the poultry stall of a market, but suggested that this mild type of virus would not pose a major threat to public health. however, the surveillance program of the university detected a new strain of h n virus and the sample was confirmed by the world health organization as having the potential to be highly pathogenic. the viruses were initially detected in apparently healthy chickens but, not long afterward, the chickens began dying in one market after another, although there were no human victims. professor k.y. yuen, who had been chair of infectious diseases since and was a member of the consultation committee of the health and welfare bureau, held detailed discussions with lily yam, secretary for environment and food, on measures to deal with the outbreak (fig. . ) . he fully supported her decision to make a pre-emptive move and slaughter more than a million chickens, ducks and geese to prevent further reassortments, possibly into pathogens that can threaten people. the influenza research team, established after the h n outbreak in , was led by professor shortridge and included dr. malik peiris and dr. guan yi, as well as ten local research assistants, all of whom worked closely with the government to identify new influenza viruses and stop them before they could infect humans. the team also cooperated with the world health organization, the u.s. national institute of health and other international health bodies. yam explained that the slaughter was ordered "to avoid the possibility, no matter how remote, of this particular strain combining to form a new strain that may affect human beings." k.y. yuen proposed a monthly rest day for retail markets, when all unsold poultry would be killed and the markets cleaned, left empty for the day, then restocked the following day. the measure was adopted by the government. shortridge and his colleagues found that virus isolation rates were significantly lower following the rest day. the pre-emptive depopulation decision halted the continuing reassortment of viruses within the poultry population and prevented the emergence of any that could attack humans. in , another incident occurred that confirmed the rapid adaptation of the h n virus. in early january, a new subset of h n -like viruses was detected in the retail markets. they were isolated from dead chickens. subsequently, a series of reports were received of chicken farms found to be infected as well as in chicken stalls in retail markets. the farms were quarantined and depopulated. a total of , chickens were slaughtered. with the cooperation of vigilant operators of chicken farms, disease recognition can take place earlier, before the chickens went to market. as shortridge observed, it was now possible to have a higher level of baseline preparedness for the next influenza pandemic. at the end of , unknown to anyone in hong kong, another deadly virus was circulating in neighboring guangdong province, propagating a disease that had no name but which was preliminarily dubbed atypical pneumonia in china and later renamed severe acute respiratory syndrome, or sars, by the world health organization. the first cases emerged in foshan city in mid-november. it spread within the province to heyuan and zhongshan. it was difficult to know what was going on in the mainland, especially where a sensitive issue like the emergence of a new disease was concerned. no announcements were made either by beijing or by local authorities in guangdong province. however, the controlled media did, at times, publish articles from which some information could be gleaned. thus, guangdong newspapers in early january published a handful of articles denying the existence of any epidemic but, by doing so, enhanced speculation of a deadly new disease. on january an article appeared in heyuan daily headlined "epidemic is only a rumor." in guangzhou, news express ran an article "no reason to worry" on january and "heyuan back to normal" on january . such articles were meant to reassure the public that the situation was under control and that there was nothing to worry about. but the articles themselves were not that reassuring. thus, the heyuan daily article described panic buying of drugs, with long lines at pharmacies. it said that the "terrifying rumor of a serious infectious disease" had resulted in a rush to purchase certain antiviral tonics. "this irrational purchasing has driven prices of these drugs to ridiculous levels: a tonic that usually costs yuan now costs yuan. antibiotics have also become more expensive, the price rising to yuan. yet no matter the price, as of p.m., these medicines were sold out at most pharmacies. until yesterday morning there were long lines waiting to buy these drugs with customers purchasing up to boxes each." the article also revealed that parents were keeping their children at home rather than sending them to kindergarten. "in the central kindergarten, two classes contained a total of kids, less than half the usual attendance," the article said. "kindergarten officials said they had also heard the rumors of a disease but didn't believe it. but just in case, they added, they had prepared a cold elixir tea to ward off any sickness." so even teachers who "didn't believe" the rumors were taking precautions. as for the disease itself, the article had this to say: "people's hospital of heyuan received two patients from zijin hospital on the fifteenth of last month. the patients were transferred to shenzhen and guangzhou. specialists from hospitals in guangzhou were sent to heyuan to help in the treatment. the hospital director said that after the meeting of provincial experts it was proven that the disease is a very common disease: atypical pneumonia. this disease is not infectious and is caused by changing weather. the symptoms are high fever, coughing and spots in the lungs. this disease is not similar to any communicable disease identified by the government so there has been no reason to report it to provincial authorities." so it seemed that heyuan was not able to look after its own patients and had to send them to other cities, and had to seek help from specialists in guangzhou. also, while saying that "the disease is very common," the article seemingly contradicted itself by saying, "this disease is not similar to any communicable disease identified by the government." there was a mysterious illness about, not just a rumor. a team of health experts had been sent to heyuan in mid-december and, on january , , these health personnel diagnosed the disease as an infection caused by a certain virus. "guangzhou is fighting an unknown virus," the mainland media reported. on january , the guangdong health department received a "top secret" document from a government health committee. however, because no one with sufficient security clearance was there, the document, which contained information about a new pneumonia-like illness spreading in the region, lay unread for three days. eventually, a bulletin was sent to hospitals across the province, but by then many health workers were on vacation because of holidays to celebrate the chinese new year, which fell on saturday, february . the chinese public, and the rest of the world, was kept in ignorance. under chinese law, any occurrence of infectious diseases should be classified as a state secret before they are "announced by the ministry of health or organs authorized by the ministry." that is to say, until the government made the information public, any doctor or journalist who disclosed information on the disease was liable to prosecution for leaking state secrets. on february , reports about a "deadly flu" began to be sent via text messages on mobile phones in guangzhou. in the evening, words like bird flu and anthrax started to appear on some local internet sites. day, two major guangzhou newspapers, the nanfang daily and the yangcheng wanbao, carried short news reports about a "mysterious illness" that had hit the hospitals in guangzhou. the next day, february , a delegation of experts from the ministry of health and the chinese center for disease control and prevention (china cdc), led by the vice minister of health and the deputy director-general of health, went to guangdong. on february , a circular appeared in the local media that acknowledged the presence of the disease and listed some preventive measures, including improving ventilation, using vinegar fumes to disinfect the air, and washing hands frequently. responding to the advice, residents in guangzhou and other cities cleared pharmacy shelves of antibiotics and flu medication. in some cities, even white vinegar was sold out. the panic spread quickly in guangdong, and was also felt in other provinces. the information blackout imposed by the mainland meant that the health authorities in hong kong were kept in ignorance of what was going on in neighboring guangdong. it wasn't until february , , when six newspapers in hong kong carried reports on the atypical pneumonia outbreak that hong kong's director of health, dr. margaret chan, and secretary for health, welfare and food, dr. yeoh eng-kiong, became aware of the epidemic next door. it was also on february that the who country office in beijing received an email message describing a "strange contagious disease" that had "already left more than people dead in guangdong province in the space of one week." the global public health intelligence network of the who also picked up media reports of an unusual epidemic of fatal pneumonia-like illness in guangdong. february was the first working day for many people after the weeklong chinese new year holiday. on that day, the who representative in china, dr. henk bekedam, received reports about an alarming outbreak in guangdong province. the son of a former who staff member sent an email to alan schnur, the communicable disease team leader of who china: "am wondering if you would have information on the strange contagious disease (similar to pneumonia with invalidating effect on lung) which has already left more than people dead in … guangdong province, in the space of one week. the outbreak is not allowed to be made known to the public via the media, but people are already aware of it (through hospital workers) and there is a 'panic' attitude, currently, where people are emptying pharmaceutical stocks of any medicine they think may protect them." mr. schnur forwarded the email at once to the ministry of health, and sought information. he added that the american embassy had passed on a similar rumor about a strange disease that was causing bleeding and many deaths in guangzhou. once the hong kong government learned from the newspapers about this health crisis, it attempted to obtain additional information, aware that previous waves of diseases, such as the global pandemics of and , had entered hong kong from guangdong province before spreading into the rest of the world. the department of health tried to telephone health officials in guangdong to find out what exactly the position was, but it failed to reach anyone in authority. when dr. e.k. yeoh asked dr. chan about the outbreak in guangdong, she told him about the department's failure to obtain any response to its enquiries. he then asked her to contact the ministry of health in beijing, since this was the established channel of communication between hong kong and the chinese government where infectious diseases were concerned ( fig. . ). it turned out that under the policy of "one country, two systems," only the central government was supposed to communicate with hong kong and not the provincial government in guangdong. dr. chan then successfully contacted the director general of the department of international cooperation of the ministry of health by telephone and expressed concern about the reported epidemic in guangdong. the director general promised to look into the matter. the following morning, the guangzhou city government held a press conference at which the director of the bureau of health, huang jiongjie, explained the situation in the provincial capital. director huang said that towards the end of , atypical pneumonia cases were reported in certain parts of guangdong province. to date, he said, more than a hundred cases had been reported in guangzhou, with many of the patients being healthcare workers. there had been two deaths. despite its quick onset, he said, the risk of fatality is low. there was, he said, no need to panic. in the afternoon, the guangdong provincial government held its own press conference. health officials reported a total of atypical pneumonia cases in the province, with five deaths. but they, too, spoke reassuringly about how the situation was under control although they acknowledged that there were no effective drugs to treat the disease and that the outbreak was only tentatively contained. a third of the cases were health workers who contracted the disease while caring for patients. that same information, that there had been about cases and five deaths in guangdong province as a result of an outbreak of acute respiratory syndrome, was also passed on to the who by the chinese ministry of health. professor yuen kwok-yung, head of the microbiology department, had kept his ear to the ground to find out what was going on in hong kong's neighborhood. unlike the government, which did not bother to monitor what appeared in guangdong newspapers, professor yuen, also known as k.y., was very concerned about the increasing reports in the media about unusual outbreaks of mysterious diseases. university of hong kong researchers were ahead of the government, which was oblivious to what hints had appeared in the mainland press. they, too, sought additional information but they, unlike government officials, had the necessary contacts. as professor yuen subsequently explained to the legislative council select committee set up to look into the government's handling of the disease, the microbiology department convened a meeting attended by four persons: k.y. yuen, the head of department, professor malik peiris, dr. guan yi and dr. b.j. zheng. at the meeting, guan yi expressed his concern that the atypical pneumonia outbreak in guangdong might be linked with h n influenza, as had happened in hong kong in (fig. . ) . he proposed a more in-depth field investigation to ascertain the infectious agents responsible for the outbreak by conducting a foray into guangzhou to find out what was actually going on and, if possible, to bring back specimens from patients suffering from this mysterious ailment for analysis in hong kong. the consensus at that meeting was that dr. guan and dr. zheng should try to contact authorities in guangzhou to facilitate the investigation (fig. . ). as peiris said, "we knew the disease was going to come over to hong kong," so it was vital to learn as much as possible before it arrived. guan and zheng were both from the mainland and knew its culture and its people. so, when a mysterious disease was reported in guangdong, it was natural that they were the ones to plunge deep into the heart of the infected areas and to shine a light into the dark corners. they left the following day, february . peiris's role was to supervise the virological investigations into the patient specimens. he would also liaise with researchers in other countries. yuen himself focused on hong kong. ever since the avian flu outbreak in hong kong, the department of microbiology had conducted frequent exchanges with mainland doctors and scholars. when this mysterious new disease emerged, researchers both in hong kong and the mainland suspected that it was again some form of bird flu. during their visit, dr. guan and dr. zheng met professor n.s. zhong (鐘南山), or zhong nanshan, a prominent educator and researcher who was head of the respiratory research center at the first affiliated hospital, guangzhou medical college. dr. zheng knew him personally, so it wasn't difficult to arrange to discuss the atypical pneumonia situation with him. dr. zhong, who had received his early training in beijing medical university and had done advanced work at st. bartholomew's hospital in london and the university of edinburgh medical school, was in charge of the management of atypical pneumonia cases at his hospital ( fig. . ). during their visit, dr. zhong told the two hong kong researchers that the atypical pneumonia outbreak might be caused by flu-like viral infection because all routine laboratory examinations for infectious agents were negative. he suggested collaboration between his institution and the university of hong kong and agreed to provide specimens from patients with atypical pneumonia for viral isolation and identification. while strictly speaking this could be interpreted as a violation of china's state secrets laws, it also could be labeled an "academic exchange" between health specialists in the mainland and hong kong. obtaining the specimens was in itself risky, since it meant direct physical contact with patients suffering from the mysterious disease. in the hospital of the guangzhou institute of respiratory diseases, the two hong kong doctors, wearing full protective gear, walked amid the patients, all in critical condition, accompanied by a nurse. some sense of what happened is provided by this account: "she [the nurse] elevated the back of the man's bed, removed his oxygen mask, and ordered him to open his mouth. tentatively reaching a wooden stick with a q-tip-like bulb at the end into the oral cavity, the nurse dabbed at the patient's tongue twice, removed the swab, and handed it to guan yi. he broke the top of the stick and dropped the swab into a vial of medium. he didn't say anything, but he could already see that this wasn't going to work. in order for it to be an effective screening, he would need mucus and phlegm from further down the patient's throat, as well as some nasal aspiration. the nurse was too frightened to gather anything but the faintest of saliva samples." guan yi decided to take over and so, at the next station, he asked the nurse to step aside as he held a female patient up, ordering her to open her mouth, and then began slapping her back gently to encourage her to expectorate mucus. "this time the swab was pressed so far down the patient's throat that when guan removed it, it was coated with a satisfactory blob of mucus that glistened under the white lights. he managed to take twelve swabs, each of which he sealed in a vial of suspension medium so that they appeared almost like miniature moth cocoons preserved in formaldehyde." so the specimens were obtained and brought back to the microbiology department to be analyzed by malik peiris and his associate, chan kwok-hung (陳 國雄), or k.h. chan. in fact, dr. zhong subsequently said that samples were not given out to other researchers simply because they didn't ask. professor yuen kept the hong kong government informed of his department's activities through telephone calls to director of health margaret chan. the microbiologist told her about the investigation into the possible infecting agent responsible for the atypical pneumonia outbreaks in guangdong and of the visit to guangzhou by two members of his department and their return with specimens. he also conveyed to her his concern that large numbers of healthcare workers were being infected. so the university and the government were in close contact from the earliest days. munity acquired pneumonia. all hospitals were required to report such cases. nineteen cases were identified in february. hong kong university researchers tried to isolate the virus causing the outbreak in guangdong. they were the only ones in hong kong with specimens, but then they hit a stone wall. the specimens brought back were inoculated into chicken embryo and other cell lines. after several days, various viruses were isolated, including the h n influenza virus, a virus that causes the common cold and one that causes respiratory infections called metapneumovirus, but there was nothing that was identifiable as the pathogen responsible for the guangdong outbreak. because bird flu, especially of the h n variety, was the chief suspect, attempts to cultivate the specimens used cell lines set up for this purpose. but they failed. a predisposition to suspect avian flu was totally natural. after all, on february , hong kong reported to the world health organization another outbreak of h n when the avian flu virus was detected in a nine-year-old boy, whose family had been visiting fujian province when he fell ill. his father had died two days previously from an infection with the same virus, and his sister had died in fujian earlier in the month, but was not tested for the virus. the who, too, saw a possible link between avian influenza and the outbreak in guangdong. however, by mid-february, malik peiris was thinking of testing for other virus groups, but was hobbled by the limited resources of his modest virology lab. he made enquiries with overseas colleagues regarding techniques for picking up other virus groups, such as coronaviruses, hantaviruses and adenoviruses. meanwhile, guan yi and b.j. zheng continued to travel to guangzhou to collect additional samples from patients. but it wasn't long before it became unnecessary to travel to guangdong to look for the virus. the virus had come to hong kong. the date it happened can be pinpointed. on february , dr. liu jianlun, a -yearold professor of nephrology from a teaching hospital in guangzhou, arrived in hong kong and checked into the metropole hotel. dr. liu had contact with patients suffering from atypical pneumonia and then developed a fever and cold, which was treated by antibiotics. though he still felt unwell, he decided to go ahead with his hong kong trip on february to take part in the wedding of his nephew. after arriving in hong kong, dr. liu and his wife had lunch with his sister and brother-in-law in a restaurant near the mong kok railway station. it was their son who was getting married. then he went shopping in central with his brother-in-law and had dinner in his home before going to the metropole hotel in kowloon to spend the night. the next morning, february , a saturday, he walked into the accident and emergency department of kwong wah hospital, which was close to his hotel. he told hospital staff that he had been in contact with patients suspected to have atypical pneumonia during february - and had developed flu-like symptoms with sharp chest pain on february . chest x-rays had showed left lower zone haziness. he said he treated himself with antibiotics (levofloxacin) and penicillin and improved. he said he had fully recovered before leaving for hong kong. but in hong kong, his fever came back and he had shortness of breath. the accident and emergency department realized this was a serious case and requested an immediate transfer to an intensive care unit. dr. watt chi-leung (屈志亮), icu director, was aware of reports of an epidemic in the mainland and put dr. liu in isolation. he also instructed icu staff to put on n surgical masks, gloves and gowns when caring for this patient. dr. watt also asked icu staff to take tamiflu as a precautionary measure. on february , there was an unexpected telephone call from guangzhou. fig. . ) . at the hospital, they went over in considerable detail with hospital doctors the clinical history, examination findings, case notes, computer records, chest x-rays, laboratory results and infection control measures relating to the patient. so the faculty of medicine was involved in the treatment of the very first sars patient from mainland china, who became known as patient zero, an extremely infectious patient who brought sars to hong kong and, from hong kong, the disease rapidly spread around the world. it is believed that dr. liu infected other guests in the hotel and, through them, something like , people in various countries became infected in less than four months as a result of travel by these hotel guests. this showed how rapidly a disease can spread in the twenty-first century. as long as the disease was bottled up in china, its impact was limited to "report on a sars patient from guangzhou who was admitted to kwong wah hospital," sc paper no. a . one country. but as soon as it spilled over into hong kong, a hub of international air travel, it quickly spread around the world. professor yuen himself participated in the treatment of the liu case. he initiated a course of ribavirin, a broad-spectrum viral agent, which is effective against respiratory, hepatitis and hemorrhagic fever viruses. despite all efforts, dr. liu died on march , ten days after he sought treatment at kwong wah hospital. by then, his brother-in-law, y.p. chan, had been admitted to kwong wah for exactly the same condition. as professor yuen said, the illness of the brother-in-law was a turning point, since another family member had been infected by the same mysterious illness. "we had," he said, "a real crisis on our hands." time was pressing. on march , the world health organization issued a global alert about cases of atypical pneumonia. it recommended that "patients with atypical pneumonia who may be related to these outbreaks be isolated with barrier nursing techniques." at the same time, who also recommended that "any suspect cases be reported to national health authorities." three days later, it issued a rare emergency travel advisory calling the disease "a worldwide health threat." it also gave the mystery ailment a name, severe acute respiratory syndrome (sars). for the special administrative region, it was an unfortunate choice of names, tarnishing the image of hong kong at best and, at worst, suggesting that the disease and hong kong were somehow synonymous. hong kong suggested a name change to the who but eventually gave up such efforts. on march , who released a list of "affected areas" with local transmission of sars. hong kong was on that list. however, as far as the who was concerned, sars was not named after hong kong. indeed, the world health body, in describing the new disease, said it was "first recognized in late february, , in hanoi vietnam." with the sars epidemic's arrival in hong kong, the university's department of community medicine became closely involved. professor anthony j. hedley, the chair professor of community medicine since , had focused on issues such as smoking, air pollution and other noninfectious health problems. sars, of course, was quite different, with its rate of infection and case fatality rate yet unknown. hedley turned to imperial college, london, for help. in an email to roy m. anderson, the head of the department of infectious disease epidemiology, he acknowledged that his department didn't have much experience in this area. i know your work, hedley said, could i persuade you to get interested in sars? could you come over and visit us? ( fig. . ). anderson needed little persuasion. he had already been asked by david heymann, deputy director of the world health organization, to be a member of its sars emergency committee. his department had a lot of experience dealing with past epidemics, ranging from aids to foot-and-mouth to influenza. as it was, heymann had asked anderson to join him on a trip to beijing to talk to the chinese authorities about sharing data on how the epidemic started, what progress there was and control measures. soon, anderson was on a plane bound for hong kong. beijing came next. in hong kong, hedley arranged for anderson to meet his colleagues, including gabriel leung, who established and directed the university's infectious disease epidemiology group, and dr. margaret chan, the director of health. together, they worked out a protocol for capturing data, analyzing the data and some public health interventions. so the department was collaborating with both imperial college and with the hong kong government. the department, anderson said, "played an important role in helping the hong kong government construct additional databases of cases, their contacts and basic demographic and epidemiological data from the midpoint of the epidemic onwards." more trips followed for anderson and members of his team. soon, imperial college and hku scholars were writing papers together. one early paper, whose principal researchers were anderson and christl a. donnelly, also of imperial college, was somewhat controversial, asserting that the case fatality rate was significantly higher than health authorities had thought, possibly up to % in people and above, and . % in younger people. as the new york times reported, this was the first major epidemiological study of the disease. the paper's authors included seven imperial college experts, seven specialists from the department of community medicine of the university of hong kong, two from the hong kong department of health, two from the hong kong hospital authority and one from the chinese university of hong kong. they explained that estimating fatality rates by simply "dividing the current cumulative number of deaths by the current cumulative number of hospital admissions" was not satisfactory because "among patients still recorded as being in hospital, it is impossible to ascertain who will eventually die or be discharged." because of the public health importance of the article, the lancet posted it online on may , , more than two weeks before it appeared in the journal itself. the imperial college-hong kong university collaboration continued after the re-emergence of sars in mainland china in . in a paper where anderson was the principal author, the group reviewed the understanding of the epidemiology, transmission dynamics and control of the aetiological agent of sars. it concluded that the low transmissibility of the virus, combined with the onset of peak infectiousness following the onset of clinical symptoms of disease, "transpired to make ibid. simple public health measures, such as isolating patients and quarantining their contacts, very effective in the control of the sars epidemic." if the time from infection to symptoms is about two days and the time from infection to peak infectiousness is also two days, then "by the time a patient reports to a physician it's too late to quarantine him" because transmission has already occurred, anderson explained. but, with sars, "the incubation period from infection to first fever is five days, the time from infection to peak infectiousness is about days, so you had a long interval and if you isolated or quarantined that patient you could stop transmission dead." that, he said, was essentially what was done since roman times with ships arriving at ports, and "sailors were put in quarantine until they were certain that they were not transmitting anything obnoxious from their travels." anderson observed that the department of community medicine, which was subsequently absorbed into the school of public health, had been transformed by the sars experience. "what sars did," he said, "was to shift its attention a little bit more to infectious diseases. and infectious diseases epidemiology is slightly different-it involves transmission dynamics, it involves contact tracing, we have a primary case, you had to understand who that person has had contact with, so it has influenced the way the people thought about infectious diseases and how best to study them." speaking of his own institution, anderson said, "we are a very quantitative group with a high computational, mathematical and statistical capability, so we probably switched them on a little bit towards more quantitative side of understanding transmission and control." the paper on the epidemic case fatality rate, he said, may well have been one of the department's first infectious disease epidemiology papers, which was followed by many more. "when you deal with noninfectious diseases, you can take your time," he observed. "epidemics happen quickly and when they start to take off they grow exponentially. the sars epidemic had a doubling time of about five to seven days, so things were moving very, very quickly. a very large number of staff in the department was switching from their normal research interest to thinking how to combat and study sars." this transformation, he said, was successful. "some very high quality work has been coming out of there in the last years," he said, which has had "a very substantial influence internationally." as soon as the emergency travel advisory was issued in mid-march, the who set up a network of scientists from laboratories around the world to try to identify the causal agent and develop a diagnostic test, similar to a network for influenza set up by klaus stohr. the laboratories were in canada, france, germany, japan, the netherlands, singapore, the united kingdom, the united states and, of course, hong kong. all were approached by telephone during the weekend of march - and all agreed to participate and to observe the who's ground rules. the purpose of the network was to unite laboratories with different methods and capacities to rapidly fulfill all postulates for establishing a virus as the cause of the disease. scientists agreed to share results in real time via a secure website and discuss findings in daily conferences. as klaus stohr wrote, "laboratories in the influenza network ruled out all influenza virus strains and other known causes of pneumonia from samples taken in hanoi, singapore and hong kong. sars looked increasingly like a new disease." of the laboratories, three were in hong kong. these belonged to the hong kong government, the university of hong kong and the chinese university of hong kong. at hong kong university, the team included medical technologist chan kwok-hung, pathologist john nicholls and leo poon lit-man. the hong kong university virology lab was the smallest, with only about six people, easily dwarfed by the government's virology lab, not to say the u.s. cdc's lab, where hundreds of people worked. in other words, the odds were stacked against malik's team in the race to identify the sars virus. dr. chan set up cell lines for the testing of specimens, dr. poon helped develop molecular diagnostic tools for fishing out unknown pathogens, and dr. nicholls (fig. . ) used electron microscopy to help identify viruses. k.y. yuen did pcr tests on the positive cell culture with cytopathic effect to exclude the presence or contamination by any bacteria that may cause atypical pneumonia, including chlamydia and mycoplasma. the situation in hong kong was worsening. by march , hospital workers and relatives of what authorities believed to be the index patient were diagnosed with atypical pneumonia, now renamed sars. most were in the prince of wales hospital, the teaching hospital of the chinese university of hong kong, and four were in intensive care. of the cases, were doctors, nurses, and other hospital personnel at the prince of wales hospital, where hong kong's major outbreak began on march . concern heightened in late march when a major outbreak of sars erupted in amoy gardens, a high-rise housing estate. actually, even before the prince of wales hospital breakout on march , malik was actively looking at the possibility of the villain of the piece being a coronavirus among other possibilities. in an email on that day to a colleague in the united kingdom, he asked for information on "coronavirus control material to be used in molecular detection assays." disappointingly, the colleague knew no one in the u.k. who was actively working on coronaviruses. very from a sars patient. the chinese university of hong kong also found paramyxovirus-like particles in respiratory samples. china was not part of the network but on march , who received a letter from china's ministry of health announcing that chlamydia was found by electron microscopy in five sars patients. actually, as early as february , the ministry of health had said to the who: "it is almost ascertained that the causal agent for the atypical pneumonia outbreak in guangdong is chlamydia." this was based on the work of hong tao, a senior microbiologist at china's center for disease control and prevention. he had announced that the causative agent was chlamydia and, because of his standing, the ministry of health accepted his finding and maintained that the causal agent for sars had already been identified. the microbiology department at hong kong university had had a head start, with specimens brought back to hong kong at the risk of their lives by guan yi and b.j. zheng. but after attempting to culture about specimens, it was still unable to identify the virus involved. of course, there was no guarantee that any of the specimens brought back from guangzhou contained the pathogen in question. where the index patient dr. liu was concerned, no bacteria, virus, fungus or parasite could be found in his respiratory secretions, blood or other body fluids. as k.y. yuen acknowledged, "basically we failed to save him and also failed to make a microbiological diagnosis." but the infection of dr. liu's brother-in-law presented another opportunity. here was a patient who was suffering from exactly the same disease. the researchers wanted lung tissue from the new patient, which, they acknowledged, was an extremely invasive surgical procedure to perform on a sick patient. but after consideration by dr. andrew wong, chief of service in medicine at kwong wah, the operation was performed and the lung tissue sent to queen mary hospital for microbiological analysis. this time, at least, the microbiological team knew for sure that the specimen had come from a patient with the mystery disease. with the failure of previous attempts, almost all the team members realized that there was now a need to try other cell lines. as k.y. yuen wrote in a joint article with malik peiris: "our colleague, dr. chan kwok-hung was encouraged to try as many new cells lines (animal cells as medium for viral culture) as possible, beyond the standard four or five that were normally used. what we needed next were luck and lots of patience." sars: how a global epidemic was stopped," . abraham, twenty-first century plague, - . yuen and peiris, "facing the unknowns of sars in hong kong." . ibid. ibid, . dr. chan decided to use a cell line of fetal kidney cells from rhesus monkeys. it was rarely used except to grow hepatitis a virus but it had also proved useful in growing a range of respiratory viruses. this was done on march . two days later, there was a visible reaction as the cells appeared to be dying, that is to say, there was a virus taking over. this was confirmed through multiple tests that eliminated the possibility of contamination. "the use of this cell line (frhk- ) was probably the most important decision in the discovery of the pathogen behind sars," yuen and peiris wrote. "the lung tissue of mr. chan yp (the brother--in-law of the index patient) was inoculated into this cell line for viral culture together with other specimens from patients with pneumonia associated with recent travel to guangdong. miraculously, significant changes were observed in this cell line." but was the virus that was killing the cells the sars virus, that is, was it the cause of the disease, or did it just happen to be present? to determine this, the hong kong university team tested their virus against blood serum samples from patients at different stages of the disease, from early onset to the late stages. the test results confirmed their suspicions. as peiris said, "we had the virus growing well, it was reacting in the expected way to early and late serum samples. we were quite sure this was the virus causing sars." by march , peiris was ready to share his findings with researchers around the world. that day, he had missed the daily conference call linking sars researchers globally. but, in an email late that night, peiris indicated that hong kong university had isolated an agent from two patients with sars. the agent was isolated in continuous rhesus monkey kidney cells. it had a cytopathogenic effect, that is to say, it caused structural changes in host cells, which indicated the growth of a virus. "in conclusion," malik wrote, "we are confident that the agent in the cell cultures are associated with the sars syndrome. the identification of this agent is under way." klaus stöhr of the who subsequently published a paper on the "multicenter collaboration to investigate the cause of severe acute respiratory syndrome" in which he recalled malik peiris' report on the agent that had been cultured in rhesus monkey kidney cells. "in addition, in an immunofluorescence assay of virus-infected cells, done in a blinded trial, sera from sars patients had rising antibody titres to the new virus isolate," he wrote. "by contrast, sera from blood donors taken long before the disease emerged in hong kong had no antibody to this virus. furthermore, virus-like particles in the cytoplasm and at the cell membrance were seen in thin electron microscopic sections from infected cells." stohr concluded: "these findings proved to be the turning point in the search for the sars causative agent. the day after he informed the who network of researchers, malik peiris held a press conference in hong kong and reported that the university had identified a virus associated with sars but that his team did not yet know what kind of virus they were dealing with. "what we have here is a new, i think it is quite a tricky disease and a tricky virus," peiris said. "it is quite important for us to study this in detail before we can come to a conclusion." the south china morning post headline proclaimed: "genetists link 'tricky virus' to pneumonia outbreak." four days later, peiris held another press conference and identified the virus as a coronavirus, so called because of the crown-like spikes on its surface. the hong kong university virologist said that his team had completed the genetic sequencing of the virus, isolated from hong kong patients. "it is not one of the two known human coronaviruses and not even any animal coronavirus," professor peiris said. "we are dealing with a type of virus which we have never come across before" ( fig. . ) . the hong kong university discovery was the culmination of a worldwide race to uncover the agent that causes sars. scientists all over the world had been working around the clock and those at the university of hong kong had succeeded at being the first to identity the elusive culprit. this was a real triumph, subsequently confirmed by the who. the centers for diseases control and prevention in the u.s. also announced the discovery of a coronavirus without mentioning hong kong's breakthrough, apparently unaware that it had occurred. it issued a press release announcing that "a previously unrecognized virus from the coronavirus family is the leading hypothesis for the cause of severe acute respiratory syndrome." however, the who took it upon itself to set the record straight. dr. david heymann, who's executive director for communicable diseases, said at a press briefing: "just so you're clear. the virus was first found in hong kong, first identified in hong kong. and then it was identified at cdc. and now it's been identified by all the other laboratories." also, just as hong kong university publicized its breakthrough before the cdc's announcement, so the university was able to get its scientific discovery into print first, with the publication of a paper in the online lancet on april , , "coronavirus as a possible cause of severe acute respiratory syndrome." the success was very much the result of a group effort, as the list of authors shows, with malik peiris as the lead writer, k.y. yuen as the last writer and others, including guan yi, leo poon, john nicholls and k.h. chan, in between. in the same issue, lancet published a commentary that said: "in today's lancet, joseph peiris and colleagues provide strong evidence that sars is associated with a novel coronavirus that has not been previously identified in human beings or animals, and begin the process of eliminating the many unknowns from this new syndrome. … one of the strengths of their report, and an important means of establishing causality, is their analysis of specimens from control patients. none of the respiratory secretions from patients with other respiratory diseases contained the coronavirus rna, and none of serum samples from blood donors had serum antibody to this new coronavirus. these findings significantly strengthen the tentative aetiological association reported by other investigators from the centers for disease control and prevention in atlanta and from toronto, who have also isolated a novel coronavirus from patients with sars." two days later, the cdc article appeared in the online edition of the new england journal of medicine, "a novel coronavirus associated with severe acute respiratory syndrome." the university's lead over the cdc, with incomparably greater resources, was clear. paradoxically, it emerged later that chinese scientists on the mainland may well have been the first to identify the sars coronavirus. this apparently happened in mid-march, , even before the world health organization had issued a global alert. scientists with the chinese academy of military medical sciences had discovered a new virus in samples from patients in guangdong province. "the virus, they had noticed, had a distinctive halo of spikes that put it in a family not known to kill humans: the coronaviruses," the magazine science reported in july , by which time the world health organization had declared all countries sars-free. "by the first week of march, the group had tentative evidence that the new virus might indeed be linked to the epidemic." the problem, as is frequently the case in china, was politics. since the highly respected senior microbiologist hong tao had made the pronouncement in february that chlamydia was responsible for the mystery ailment, the ministry of health had accepted this view and the official chinese establishment would accept no other view. so the academy's microbiologists kept their mouths firmly shut. "these scientists were the first ever to see the sars virus," klaus stohr of the who said after visiting the academy, "and we had no idea." just like the outbreak in guangdong, when chinese patients and medical workers lacked information because of the communist party's penchant for secrecy, china was a victim of its own policies, this time of obstinately sticking to a position just because someone in a position of authority had made a pronouncement. the discovery of the sars coronavirus was a huge step forward in the war against the deadly disease, but by no means did it mark the end of the war. in fact, things were to get much worse before they got better. the hong kong director of health made sars a statutorily notifiable disease by revising the quarantine and prevention of disease ordinance so as to provide the legal basis for mandating close contacts of sars patients to report daily to one of four medical centers. all secondary and primary schools and preschools were temporarily suspended. the rolling stones canceled their concert, scheduled for march and . on april , the world health organization issued the most stringent travel advisory in its -year history. it recommended that "persons travelling to hong kong and guangdong province consider postponing all but essential travel until further notice." once the sars virus was grown in the laboratory and identified, it became possible to decode its genome and identify its genetic makeup. it also was possible to identify it in the body. tests could be carried out to see what effect potential treatments had. for example, in response to demand for an antiviral cure for sars, various drugs were tested. in one test, the clinical response of patients with sars to a combination of lopinavir/ritonavir and ribavirin was examined and compared with patients treated with ribavirin only who served as historical controls. the treatment was found to be significantly more effective than that provided in the historical control group. just about this time, hong kong received a rare visit from a chinese leader. premier wen jiabao visited the city in mid- , the first national leader to do so since the devastation of sars. the premier went to the university of hong kong and praised its role in the battle against the killer disease. the premier met the key figures involved, the head of microbiology professor k.y. yuen, the chief of virology professor malik peiris, and virologist at the department of microbiology, dr. guan yi. the premier was briefed by professor yuen on how, despite limited resources, the university was able to track down the agent of sars while dr. guan explained how animal viruses were discovered. within weeks of the discovery of the sars coronavirus, the viral genome had been completely sequenced, with hong kong university coming third in that race, following researchers in canada and the united states. the sequencing showed a virus that had begun life in an animal before it mutated and began to infect people. animal-or animals-carried the virus that mutated and was able to infect people? in order to prevent a recurrence of sars, it was important that an answer be found to this question. in the case of avian flu, chickens and ducks were the culprits. were domestic animals also responsible for sars? professor zhong nanshan had reported that one of the earliest sars cases in heyuan was a chef who had come into regular contact with several types of live caged animals used as exotic game food. because of this, guan yi and b.j. zheng, who led the effort to identify the animal host of the sars virus, focused their attention on wild animals recently captured and marketed for culinary purposes. while malik peiris and his people were toiling in their labs, guan yi was busy testing animals being sold in wet markets in guangdong to see what viruses they harbored. on may , , the results of a joint study by research teams in hong kong and shenzhen of wild animals taken from a market in southern china were released. the study detected coronaviruses closely related genetically to the sars coronavirus in two of the animal species tested-the masked palm civet and the raccoon dog. the study also found that a chinese ferret badger elicited antibodies against the sars-cov. the study provided for the first time an indication that the sars virus exists outside a human host. "sequencing of viruses isolated from these animals demonstrated that, with the exception of a small additional sequence, the viruses are identical with the human sars virus," it said. "information on the potential role of animals in the transmission of sars is important to overall understanding of sars. at present, no evidence exists to suggest that these wild animal species play a significant role in the epidemiology of sars outbreaks. however, it cannot be ruled out that these animals might have been a source of human infection." the wild animals sold at markets are traditionally considered delicacies and are available throughout southern china, the study reported. largely because of the findings of this joint study, conducted with the shenzhen centers for disease control, the guangdong government temporarily banned the sale of civet cats and closed down wildlife markets. but the ban was lifted a few months later after another mainland team challenged the findings and after the war on sars was believed to have been won. nevertheless, guan yi and b.j. zheng persevered, conducting further researches in guangdong's live-animal retail markets. "animals were held, one per cage, in small wire cages," they reported about one shenzhen market. "the animals sampled included seven wild, and one domestic, animal species. they originated from different regions of southern china and had been kept in separate storehouses before arrival to the market. the animals remained in the markets for a variable period of time, and each stall holder had only a few animals of a given species. animals from different stalls within the market were sampled. nasal and fecal samples were collected with swabs and stored in medium with bovine serum albumin and antibiotics. where possible, blood samples were collected for serology." sampling was carried out in shenzhen from the end of october and in guangzhou from early december . altogether, wild animals were sampled between october and january by guan and his team. of these, were positive for sars-cov-like virus, with palm civets found to be the most often infected. they discovered that "the recent sars-cov sequences from wild animal specimens collected from southern china from october to january are much more like the human sars-cov sequences from may . this indicates that the sars covs present in wild animals in southern china are heterogeneous, are continuing to evolve, and have also acquired mutations making them potentially infectious for humans." as it turned out, because of guan yi's efforts, not only was an animal link to the sars virus uncovered but another sars outbreak in guangdong was narrowly averted. on december , , a suspected human case of sars was reported in guangzhou and the patient was quarantined. the center of disease control and prevention of guangdong confirmed the case as sars. the viral genomic sequence from this new sars case was almost identical to that from palm civets, suggesting that the human patient might have acquired the infection from palm civets or other wild animals in the wet markets in guangdong. so great was the danger of another sars outbreak in guangdong among the human population that guan yi decided to appeal directly to the powers that be. as the year began, he sat down and wrote a letter to china's hong kong and macau affairs office, copies of which were also sent to the ministry of health and china's centers for disease control. "with winter coming, the wildlife markets have reopened, providing the perfect conditions for another outbreak of sars," he wrote. he listed his findings on the civet cat as a major carrier of the sars coronavirus, as well as the fact that other wild animals, too, carry the virus. he enclosed four pages of genetic sequences taken from civets. the letter was hand delivered on january . the very next day, he was invited to guangzhou to make his case in front of the most eminent scientists in the province, including professor zhong nanshan, and clinicians who had treated patients during the sars outbreak the previous year. while they were speaking, the amino-acid sequences of the human patient recover- ing from sars in a guangzhou hospital were sent to hong kong for sequencing. in an hour, the results were in: the sars patient's virus sequences were almost identical to that of the virus sequences of the palm civets. that is to say, the virus in the wild animal markets had somehow infected a human. the group decided then and there to contact the provincial governor and recommend a cull of all civet cats. professor zhong telephoned governor huang huahua recommending the slaughtering of all civet cats in the markets. the order to carry out the slaughter was given on january , , involving an estimated total of , civet cats. at a news conference in hong kong the day the order was issued, dr. zhong joined hong kong university microbiologists to announce that they had jointly completed a detailed study of sars-like viruses in civet cats together with a genetic analysis of viral samples taken from a -year-old man in guangzhou who was suspected to have sars. k.y. yuen said that while research the previous spring had shown that the sars virus that infected more than , people around the world was genetically very similar to a virus in civet cats, new research shows that the virus in civet cats "has mutated to form a new 'sublineage' of the virus." he said that a genetic sequencing of samples from the infected man in guangzhou had found that the main "spike" of protein was exactly identical, down to the last amino acid, to the new sublineage of the virus found in civet cats. professor zhong warned that civet cat feces could dry up and become windblown dust that would raise a risk of airborne infection. he said the feces carry extremely high concentrations of the virus, which can still be detected even when the feces are diluted as much as one billion times. professor yuen's conviction of the role of civet cats in the transmission of the sars virus to humans was reflected in testimony he gave in early january to the legislative council select committee set up to inquire into the handling of the severe acute respiratory syndrome outbreak by the government and the hospital authority. at one point, legislator chan kwok-keung (陳國強) asked about the origin of the virus and this exchange took place: legislator: "professor yuen, i want to ask, just now you said virus came from… some came from hospitals, some came from the community. in reality, did the virus originate from the community or from hospitals?" professor yuen: "this virus? if your question is how did the thing get here, you would never get an answer. by way of example, we currently believe that the most important source is civet cats, but in reality we cannot be % certain unless in the same second, we can give all animals in the world a one-off examination. then, we can be very certain. based on the evidence we have at the moment it mainly started from wild animals." the guangdong culling operation of civet cats began on january and the last case of sars appeared on january . after that, no new cases of sars emerged, despite the chinese new year which, as usual, saw large numbers of people traveling as they returned home for the holidays. thus, the january cull in guangdong, like that of december in hong kong, must be deemed a success in averting a pandemic. however, farmers of civet cats suffered economic disaster. researchers found that civets on farms were largely free from the virus, though those in overcrowded retail markets, where civets are put in close proximity with other species, are often infected. this raised the question whether the civet cat was the main conduit for sars or whether it was infected by another animal, which was the real reservoir of the virus. professor yuen decided to turn his attention to other animal species in the wilderness that may be carriers of similar viruses. not everyone was as enthusiastic as yuen in his efforts to gather evidence that might in effect exonerate the civet cat, after so much publicity had gone into slaughtering civet cats in guangdong. but yuen persevered, doing his research in hong kong, screening for coronaviruses in wild animals within the territory. in this he was successful. he found that the chinese horseshoe bat was the natural reservoir of sars coronavirus-like viruses. so the bats might well have infected civet cats, possibly via yet a third animal. the public health implication was that animals, such as bats, should not be mixed together with other species in wildlife markets, as was the case before . the microbiology department did not stop there. it went on to sample animals for novel viruses and, by , had identified novel animal viruses. most of them were named after hong kong or after hong kong university, such as the bat coronavirus hku found in lesser bamboo bat and the bat coronavirus hku found in the japanese pipistrellus bat. not much notice was taken of these novel viruses but, after the emergence of middle east respiratory syndrome, both were mentioned in a paper about a man who died in saudi arabia. "a previously unknown coronavirus was isolated from the sputum of a -year-old man who presented with acute pneumonia and subsequent renal failure with fatal outcome in saudi arabia," began an article in the new england journal of medicine in . "the virus (called hcov-emc, later mers-cov) replicated readily in cell culture, producing cytopathic effects of rounding, detachment, and syncytium formation. the virus represents a novel betacoronavirus species. the closest known relatives are bat coronaviruses hku and hku ." thus, hong kong university identified novel animal coronaviruses prior to the emergence of this highly fatal infection in the middle east and subsequently korea. hong kong paid a high price for sars, with more than , people laid low by the disease, with deaths. in , the government awarded professor yuen a silver bauhinia star for his discovery of the coronavirus that causes sars. professor yuen modestly said the award was recognition for all members of his team. "the award has helped boost the morale of my team," he said. "my colleagues, including malik peiris and guan yi, put a great deal of effort into tracing the source of the sars virus to civet cats. there are many more people who have made a lot of contribution." the university gave all three men-professor yuen, professor peiris and dr. guan-the special research achievement award in recognition of the team's groundbreaking discovery of the coronavirus responsible for the ourbreak of sars. one interesting achievement of his team, professor yuen said, was that at one stage it collected the highest number of flu strains in the world; but, he added with his customary modesty, by now "the beijing and the harbin group should have superseded us already." quite aptly, members of the entire team of scientists were called "heroes of the sars wars" by bloomberg. "asia also has the global scientific community to thank for quickly mobilizing to understand the mysterious new virus," bloomberg his identification of the chinese horseshoe bat as the natural host for the virus (fig. . ) . malik peiris, too, received a wealth of awards. reflecting his international outreach, the honors bestowed on him came from overseas, including the united kingdom, where in he was elected a fellow of the royal society of london, the highest scientific honor in the commonwealth. the following year, he was awarded the chevalier de la legion d'honneur by france as well as the mahathir science award by malaysia for the role he played in the discovery of the aetiological agent of sars. recognition from the hong kong government came in when he received the silver bauhinia star for "outstanding achievements in the field of virology and pathology, in particular his contribution to the prevention and control of infectious diseases." today, all three men are listed among the world's most frequently cited researchers in the field of microbiology. that is to say, they are among the top % of researchers in their field internationally. in , thomson reuters listed professors yuen, peiris, guan and poon among the "world's most influential scientific minds" (fig. . ) . so the microbiologists achieved recognition both within the university and from society at large, in hong kong and internationally. "in , we only had or people," k.y. yuen recalled. "now, microbiology has over a hundred people." at the same time, the school of public health has well over staff. "so," yuen said, "you can see the power of money. as a result, we can do much more research, and we have much better output." without the title of state key laboratory, yuen said, they would never have received this money. the people working on microbiology today include both those in the department itself and in the public health school. while both the department and the school do virology and pathogenesis, the department works more on clinical diagnosis and treatment while the school focuses more on epidemiology. they share the teaching load for medical students. k.y. yuen was promoted to chair professor in , malik peiris moved up from senior lecturer to become professor and, after sars, to chair professor. guan yi has risen from a research assistant professor when he first joined the university to professor to co-director of the state key laboratory of emerging infectious diseases and professor of virology. in january , he was promoted to chair professor. such growth in personnel, plus internal promotions, would not have been possible without greatly increased funding. the designation of state key laboratory in mainland china would ordinarily come with substantial funding but, because the university is in hong kong, it cannot directly receive such funds from beijing. from , when the title was granted, until , it could only apply for limited funding within the mainland, which had to be spent on collaborative projects with mainland researchers. however, beginning in , the hong kong government started to provide funding to the state key laboratory through what is now its innovation and technology bureau, to the tune of $ million a year. this was a highly appreciated windfall and, with this additional funding, the department has grown much faster in recent years. the physical laboratory at the university has also been upgraded. laboratories are graded by biosafety levels, measuring the biocontainment precautions required to isolate dangerous biological agents in an enclosed facility, ranging from to . at the time of sars, the laboratory was at a biosafety level of p + and, in , it was upgraded to a p . yuen thinks it may never become a p -the kind of lab where all the researchers wear astronaut suits because they are working on something very dangerous, like ebola. in the aftermath of such traumatic events as the h n outbreak of , followed by sars six years later, hong kong learned that vigilance was vital. the government was determined that whenever the next health challenge arose, it wouldn't be unprepared. in june , hong kong set up the center for health protection (chp), using the centers for disease control and prevention in the united states as a model. creation of the center was recommended by the sars expert committee appointed by chief executive tung chee-hwa. the government also earmarked a one-off grant of $ million to support research into emerging infectious diseases. while $ million was to support infectious disease research in the mainland, the bulk, that is, $ million, was directed to support local investigator-initiated research and commissioned projects through the creation of the research fund for the control of infectious diseases. the aim of the fund was to encourage, facilitate and support research on the prevention, treatment and control of infectious diseases. this was superseded in with the creation of the health and medical research fund, with the injection of an additional $ billion. on a down-to-earth level, the government took steps to ward off or at least mitigate the return of avian flu. retail markets for live poultry came under close supervision. rest days were introduced during which retail markets for live poultry were closed and thoroughly cleaned. tests showed that viruses were dramatically reduced after a rest day. live chickens were no longer imported from mainland china. those taken to market came from local farms, and any chickens not sold at the end of the day were not returned to the farms but slaughtered, so that viruses could not be introduced-or reintroduced-onto farms from retail markets. the university of hong kong, too, responded to the new situation. in , it approved a proposal to establish a school of public health, which was formally inaugurated in . the university was invited to submit proposals for research related to basic laboratory, epidemiological and public health research in emerging infectious diseases. the university was asked to participate because of its pioneering work in discovering the sars-coronavirus, its outstanding work on avian influenza a (h n ) research and surveillance, and its track record of peer-reviewed publications, especially in journals with high impact factors. the university submitted a proposal, "research preparedness for emerging and potentially reemerging infectious diseases in hong kong." as a result, $ million was approved for it to undertake a five-year portfolio of basic laboratory, epidemiology and public health research, as well as upgrade its bio-safety level laboratory with enhancement for animal experimentation. it was just as well that hong kong was consolidating its infectious disease and virology expertise and facilities after sars because another storm was brewing. in march , there was an outbreak of "flu" in a town called la gloria in veracruz, mexico. it affected % of the town's population and killed three children. it was believed to be the "common flu." between th and th april, specimens collected from two children with flu in california, u.s.a., were shown to have a strain of "swine flu" called h n . on april , the world health organization issued a disease outbreak notice confirming the infection of a number of people in mexico and the united states by swine influenza a (h n ) viruses not previously detected in pigs or humans. the th was a friday and malik heard the news friday night. he gathered the "flu team" for a meeting the next day when they discussed what steps to take. a priority was to set up diagnostic tests for detecting the virus when it arrived in hong kong, as it inevitably would. they had the sequence of the virus provided by the u.s. cdc but for such molecular detection tests a positive control virus is needed to establish that the test is working properly. the new pandemic h n virus was not available in hong kong. but a decade-long surveillance of swine influenza viruses provided a source within which to search and, indeed, a virus close enough to serve as the positive control was found. the next question was to understand the origins of the virus. it was decided to start genetic sequencing of the many hundreds of swine influenza viruses available from this surveillance effort. by april , jose angel cordova, the minister of health for mexico, was reporting that , cases had been detected, people had died and an additional were in hospital. these were alarming statistics. on april , the u.s. declared a public health emergency and, the following day, the world health organization raised its pandemic alert to level , with being the highest. on may , hong kong confirmed its first case of swine flu: a mexican national who had arrived via shanghai and stayed at the metropark hotel. it was the first reported case in asia, and the hong kong government responded with the seriousness that it warranted. the alertness level was raised to "emergency." with the example of dr. liu jianlun-the guangdong doctor who stayed overnight in the metropole hotel and infected more than a dozen other guests and visitors-seared into its collective memory, hong kong was not going to take any chances. while the -year-old mexican patient was treated in isolation in hospital, the metropark hotel was quarantined and its roughly guests kept in confinement for a week despite their protestations. other interventionst measures learned during sars included the closure of schools-primary schools, kindergartens and special schools, initially for two weeks and then extended to the summer holidays. historically speaking, hong kong had been identified with influenza research for decades. the pandemic, after all, was named hong kong flu after having first been identified in the city. then the bird flu saga of and sars in put hong kong on the front lines of emerging disease outbreaks. "as a result, hong kong has invested heavily in infrastructure in preparation for future epidemics and pandemics," explained one paper commenting on the territory's public health research response to the outbreak. "there has also been substantial investment in research infrastructure, essential to guide evidence-based policy locally as well as internationally." thus prepared, even before the first case was reported in hong kong, it operated under containment efforts, including entry screening at airports, ports and border crossings, hospital isolation of cases, tracing and quarantine of contacts, and routine antiviral prophylaxis. on april, hong kong raised its alertness level from "alert" to "serious," just one step away from "emergency." the next day, the world health organization, too, raised its alertness level. dr. keiji fukuda, who's assistant director-general, explained that the increase in pandemic alert level was in response to the outbreak of swine flu that had originated in mexico, but that it did not mean that a pandemic was "inevitable." hong kong also made swine flu a notifiable disease, a step it learned from its sars experience. "actually, we had a number of research grants for pandemic preparedness," recalls professor benjamin j. cowling, head of epidemiology biostatics in the school of public health. "this allowed us to scale up for research into the pandemic, so when the pandemic actually came here, we did a number of studies which were the envy of most other places in the world" (fig. . ) . a crucial question was how effective were these various measures at warding off the arrival of swine flu, verifying its severity and preventing or deterring its spread? entry screening, cowling and his colleagues determined, could delay local transmission for one to two weeks. "a delay of one to two weeks could be useful if the additional time permits more comprehensive planning and preparation for a local pandemic, or shortens the time required for other pandemic mitigation measures such as schools closures to be sustained," they wrote. "however, the benefits of local screening should be balanced against the considerable resources required to implement screening." still, when the virus reached hong kong, it spread rapidly. within five months, % of children in hong kong were infected. fortunately, it was not as severe as initially feared but the speed with which it spread was astounding. if it had been really virulent, there could have been a global catastrophe. while the disease emerged first in north america, by may , it had spread to countries, causing the world health organization to raise its pandemic alert to level of . hong kong knew that it would not be spared. only the previous year, the government had created the post of under secretary for food and health, with professor gabriel leung as the first occupant of the post. when h n emerged, he mobilized his former colleagues at the university to respond (fig. . ) . in the u.s., the situation was worsening. a health alert was issued to doctors, who were warned of a new strain of swine flu that was a combination of swine, avian and human influenza that had not been seen before. the national broadcasting corporation (nbc), seeking expert views on the situation, was able to contact professor guan yi, who was at that time in india, helping to set up a poultry influenza surveillance network. he was at the bombay airport when nbc managed to reach him to ask for urgent comment on the spread of swine flu to humans. guan yi's immediate response was that it was not easy to detect this kind of virus. after all, the h n virus was already in humans, as a human virus. guan yi went to work immediately after returning to hong kong. he told his team, "we need to find out how this virus was generated and where the virus came from." they had an advantage in that hong kong was probably the only place in the world where there had been close surveillance and sampling of swine for over a decade as part of its anti-influenza program. guan yi, who had written his doctoral thesis on swine flu, had accumulated data on the subject while a student in the s under ken shortridge, who himself had data going back to the s. so while the rest of the world was short on information regarding swine, hong kong was data rich. guan yi and his associates set to work on the unique data available to them. according to guan, the bulk of the analysis was done in one intensive week of work, from april to may . with help from andrew rambaut, an evolution scientist with the institute of evolutionary biology at the university of edinburgh, they were able to "understand the evolutionary pathway of this virus." "here we use evolutionary analysis to estimate the timescale of the origins and the early development of the s-oiv epidemic," the paper explains. "we show that it was derived from several viruses circulating in swine, and that the initial transmission to humans occurred several months before recognition of the outbreak." while surveillance and sampling had been taking place in asia, this was not true of north america, and as a result there was "a long period of unsampled ancestry before the s-oiv outbreak, suggesting that the reassortment of swine lineages may have occurred years before emergence in humans." furthermore, it said, "the unsampled history of the epidemic means that the nature and location of the genetically closest swine viruses reveal little about the immediate origin of the epidemic…. our results highlight the need for systematic surveillance of influenza in swine, and provide evidence that the mixing of new genetic elements in swine can result in the emergence of viruses with pandemic potential in humans." the paper was submitted to the journal nature for publication on may ; it was accepted june and was published online june . the timing was fortuitous. june was the day when dr. margaret chan, director-general of the world health organization, announced the raising of the level of influenza pandemic alert from phase to phase , the highest level. "the world is now at the start of the influenza pandemic," she declared somberly. this means that on may , when the paper was submitted, "even before the world knew what was happening"-in the words of guan yi-"i provided critical information to the world with the university of hong kong catching the attention of the world." the university's virologists were keen to study this novel virus, which was spread not by birds but by pigs. a study of the lineage of the h n / viruses showed that three major lineages of swine h influenza viruses had been prevalent in pigs in surveys conducted in hong kong over the past years. the h n flu virus was a triple reassortant, combining the classical swine h n , the european "avian-like" h n and triple-reassortant h n (trig) viruses. and while the virus had jumped from pigs into humans, actually this had happened more than once. "after circulating in humans for some time they jumped back to pigs and tried to reassort with other pig virus," reported professor leo poon, a diagnostic expert in identifying viruses. "that was quite interesting because it highlights the pig as a major reservoir, or intermediate host." a paper published in the prestigious science journal, co-authored by leo poon, guan yi, malik peiris and others concluded: "the pandemic, although mild and apparently contained at present, could undergo further reassortment in swine and gain virulence. it is therefore important that surveillance in swine is greatly heightened and that all eight gene segments are genetically characterized so that such reassortment events are rapidly identified." observations made over years of pigs in a hong kong abattoir were able to show that all major lineages of swine viruses of north american or european origin were present in chinese pigs from different provinces shipped to hong kong for slaughter. although pigs, unlike birds, don't fly, they are exported from one country to another, often for breeding purposes. so, although the epidemic did not emerge in china but in mexico, analysis of pigs in china was able to show how the mixing of viruses was occurring. peiris and his colleagues argued that similar events probably had also occurred, undetected, in mexico. indeed, they were right, but it took another years to find these viruses in mexico. so great was hong kong's input that, in - , it contributed half of all the known swine influenza genetic data in the world. the diversity of genetic variants found in the studies by the hong kong group also allowed them to understand the genetic determinants that allowed a human transmissible virus to emerge from these precursor swine viruses. according to cowling, when there is a new influenza virus, the three immediate priorities of public health officials are to determine, first, how quickly it spreads between people, how severe the infections are, and what the options are for controlling it, that is, what can be done and the potential for success of such efforts. "the research that we did here covered all three of those important areas," he said, whereas other research groups or government ministries are usually unable to do that. another project that cowling and his team did was a comparison of the h n virus and seasonal influenza viruses in community settings. fortuitously, cowling was in the midst of doing household transmission studies when h n struck. he identified patients with flu in the clinics of general practitioners, then requested permission to test members of the household. when the epidemic arrived, he continued this work. the information that he was able to gather turned into a very important paper. for one thing, there is very little research data on the comparative epidemiology and virology of the pandemic influenza a (h n ) virus and co-circulating seasonal influenza a viruses in community settings. cowling and his team recruited index patients with acute respiratory illness from outpatient clinics in hong kong in july and august . they then followed household members of patients who tested positive for influenza a virus on rapid diagnostic testing and collected nasal and throat swabs from all household members at three home visits within days for testing. they were able to conclude that pandemic h n virus has characteristics that are broadly similar to those of seasonal influenza a viruses in terms of rates of viral shedding, clinical illness and transmissibility in the household setting. "the household transmission studies allowed detailed inferences on the transmissibility of ph n as well as the (mild) clinical profile of cases in the community," a review of hong kong's public health research response to the pandemic concluded. "household studies have the unique advantage of a natural setting that allows comparisons of transmission characteristics and the effects of host, viral, and environmental factors on transmission." one study by cowling and his team was to establish the transmissibility and virulence of the pandemic strain, information that was a priority for national and international health authorities in . patient data on all laboratory-confirmed pandemic h n cases reported between may and november , were collected by the hospital authority and the center for health protection. during that period, h n infection was a reportable disease, so the data collected was likely to be comprehensive. the information included demographic date on age and sex, clinical information including illness-onset date, laboratory-confirmation date and hospital-admission date. the researchers found that the estimated reproduction number of pandemic h n appeared to be lower in hong kong than in other countries. the hospital admission rate in hong kong was high due to broader admission criteria, "with young children and pregnant women routinely admitted for testing and investigation." while the overall number of severe hospital cases was not high, professor k.y. yuen found that for severe cases, the viral load in the respiratory tract didn't decrease rapidly despite oseltamivir treatment. this led him and his associates to try another method: they selected mildly infected patients with a high level of neu-tralizing antibody and used the convalescent plasma of these patients to treat those severely ill. yuen found that the treatment of severe a influenza (h n ) within days of symptom onset was associated with a lower viral load and reduced mortality. the mortality in severely ill patients treated by convalescent plasma was % whereas those treated by tamiflu alone was . %. dr. joseph t. wu of the school of public health led a study on the infection attack rate and the infection-hospitalization probability from data provided daily by the hospital authority and the department of health, from which he could construct an epidemic curve describing how fast the disease was spreading in hong kong. "the hospital authority gave us the number of confirmed infections and hospitalizations each day," dr. wu explained, "and so data can easily be obtained on the severity of the h n infections." wu also approached research on the infection attack rate and severity from a different angle. working together with the hong kong red cross, researchers tested , blood samples from blood donors during the period when the virus was active. they discovered that almost half of all schoolage children in hong kong were infected during the first wave. however, because the symptoms were mild, few of them went to hospital. paradoxically, a much smaller percentage of older adults aged - years were infected, but a much higher percentage went to hospital. if it wasn't for the serological tests, such a phenomenon may have gone undetected and the disease may have been thought to be one that primarily attacked older people. wu and his team also measured the impact of school closures on the mitigation of the h n pandemic. they concluded that the closure of secondary schools for the summer vacation "was associated with substantially lower transmission across age groups," and estimated that reporting of cases "declined to . % of its initial rate through the second half of june." by comparison, attack rates in previous epidemics have generally been highest in younger children, and this was true in mexico and chicago. this finding, they reported, "intuitively implies that closures were effective in preventing infections in this age group" ( fig. . ). the data generated by the university was shared with the government and the who, giving them real-time situation awareness of the pandemic, even before the relevant papers were published. so impressive was hong kong's performance that at the second global influenza seroepidemiology expert meeting sponsored by the european center for disease prevention and control in in stockholm, the chairman, angus nicoll, speaking on sustainability of serological surveillance, cited two options: "routine annual surveys," such as those conducted by israel, norway and poland, or "fast ad hoc quality research," a la hong kong. at one point, he said, "in the next pandemic, maybe all of us should subcontract our epidemiology work to hong kong." at the end of march , a new virus was detected in china. first, a father in shanghai became ill of severe pneumonia and died. then two sons also developed quite severe pneumonia. this was scarily reminiscent of the sars epidemic a decade previously. while they tested negative for sars, it turned out that they had influenza, but a hitherto unknown kind of flu, h n . the chinese authorities responded quickly by establishing a joint multi-sectoral coordination mechanism, initiating several investigations, notifying the world health organization, sharing viruses with who's influenza collaborating centers and other laboratories and mounting effective counter measures such as closure of live poultry markets in some locations. subsequently, who undertook a six-day joint mission to china. malik peiris was part of the mission. live bird markets were an immediate suspect. even though some people refused to believe that the virus came from chickens, shanghai closed all live bird markets and human infections disappeared. that made it quite clear that the retail poultry market was the cause. china cdc did a lot of work, but encountered opposition from those involved in the poultry trade and in agriculture. because the poultry didn't sicken, farmers weren't too concerned about whether they were infected or not. and while closing live markets was effective in combating the virus, it was also extremely costly. a joint assessment was made by experts from china and the who. "what we found is the virus is located in lots of different parts of china," recalls fukuda, who was assistant director-general for health security of the who at the time. "we also found that the risks of getting infected appeared to be similar to h n , some kind of contact with infected markets, with poultry markets. we also saw that when cities took control measures, close down markets, clean up markets, you could reduce the infection." it was, malik said, "like the h story all over again. difference is that h is even more dangerous than h because it was able to infect humans more easily and because it caused no illness in birds-that is, it was a virus able to spread silently in poultry. since , h n has continued to be present in china and, in fact, there was an upsurge in . however, according to fukuda, "we don't see major changes in the virus, or that it's more transmissible; based on what we know both in and now, it is a reflection of an increase in infection in birds and increased contact between humans and infected birds." fukuda is quick to compliment researchers in the school of public health, now his colleagues, such as "malik, guan yi and leo poon, and ben cowling." this group, he said, "has continued to operate at a very high level. the university here has such a strong research team, and they have collaborators in china." in , when swine flu was first reported, guan yi was traveling in india. on march , , when china reported to the world health organization the detection of three cases of human infection with a novel influenza a (h n ) virus, he was again traveling. but this time, he was on holiday with his family in guilin, china, the country where the outbreak was occurring. his immediate thought turned to the recent reports of thousands of dead pigs found floating in the huangpu river in shanghai, which had been dumped in the water by farmers. it crossed his mind that the dead pigs and sick humans might be connected. after returning to hong kong, guan tested samples of the virus on various animals, including pigs, and concluded that the h n virus did not kill the pigs. that was one less thing to worry about. but the main concern was the infectivity and transmissibility of this new virus. a group of scholars from the university of hong kong and from shantou university, plus international and mainland chinese experts, published an article in science magazine. these scholars conducted experiments on ferrets, which are considered the primary mammalian model for human influenza. while healthy ferrets inoculated with the virus displayed a brief fever one or two days after inoculation, with "robust sneezing and nasal discharge," and three ferrets placed in direct contact with the inoculated group displayed similar symptoms, only one of three airborne-exposed ferrets displayed such symptoms, suggesting that transmission by air was much less efficient. though the paper was formally published july , it was submitted april , accepted may and published online may . "we were," guan yi said, "the first team in the whole world to publish such a paper to define virus infectivity and transmissibility." another paper in the lancet showed that h n was much more efficient at infecting the human bronchus than h n so that the chance of getting infected and potentially transmitting it to others was higher. still, the question was, where did this new virus come from? the answer, like that for h n , was poultry. "china has the largest poultry population in the world," guan yi observes. "domestic duck is the natural host of influenza virus, and % of domestic ducks in the world are in china. likewise, % of domestic geese are in china." at the time, it wasn't clear which animal was the host to the virus, so guan and his key associate huachen zhu, also known as maria, sampled all major poultry from markets. "we pinpointed chicken as the source," guan said. surprisingly, the virus was in the respiratory tract, not the digestive tract. some people, zhu and guan said, offered the pigeon as a possible suspect, because the pigeon population is relatively small and the economic impact of its obliteration would be less damaging, but they showed beyond doubt that the chicken was the culprit. while the paper did not appear until the october issue of nature-and even the online edition wasn't published until august, it was submitted on may , less than two months after the discovery of h n and at a time when china's ministry of agriculture was arguing strongly that chickens were not the source. again, a group of experts, including guan yi, was able to show how the h n virus emerged from wild bird and chicken viruses. "preliminary analyses suggest that the virus is a reassortant of h , n and h n avian influenza viruses, and carries some amino acids associated with mammalian receptor binding, raising concerns of a new pandemic," they wrote in nature, in an article submitted on may , . "however, neither the source populations of the h n outbreak lineage nor the conditions for its genesis are fully known." they went on: "here we show that h viruses probably transferred from domestic duck to chicken populations in china on at least two independent occasions. we show that the h viruses subsequently reassorted with enzootic h n viruses to generate the h n outbreak lineage." field surveillance was conducted in wenzhou, in zhejiang province, rizhao, in shandong province, and in shenzhen, in guangdong province. according to the authors, previous analyses suggested that the n gene of the h n outbreak lineage was derived from wild bird viruses in europe and korea. however, their data showed that, for this gene, more closely related h n and h n viruses were found in migratory wild birds in hong kong in - . the authors concluded: "domestic ducks seem to act as key intermediate hosts by influenza viruses from migratory birds, by facilitating the generation of different combinations of h and n or n subtype viruses, and by transmitting these viruses to chickens. after transmission, reassortment with enzootic h n viruses formed the current h n or h n viruses seen in chickens. this probably led to outbreaks in chickens, resulting in the rapid spread of the novel reassortant h n lineage through live poultry markets (lpms), which then became the source of human infections. the cessation of human infections after the closure of lpms, after a precedent set during the hong kong h n 'bird flu' incident in , strongly supports this proposition." so the virus went from wild birds to domestic ducks to chickens, before infecting humans. the authors reported the discovery of an h n virus in chickens that has the ability to infect mammals experimentally. this, they said, suggests that h viruses may pose threats beyond the current outbreak. "the continuing prevalence of h viruses in poultry could lead to the generation of highly pathogenic variants and further sporadic human infections, with a continued risk of the virus acquiring human-to-human transmissibility," they warned. another paper, produced with high input by maria zhu, appeared in june in nature again. it was on the dissemination, divergence and establishment of h n viruses in china. the authors showed that since h n was first reported in march , the virus had spread from eastern to southern china and had become persistent in chickens. moreover, repeated introduction of viruses from zhejiang to other provinces and the presence of h n viruses at live poultry markets had fueled the recurrence of human infections. "the rapid expansion of the geographical distribution and genetic diversity of the h n viruses poses a direct challenge to current disease control systems," the authors reported. "our results also suggest that h n viruses have become enzootic in china and may spread beyond the region, following the pattern previously observed with h n and h n viruses." while the article appeared in print in june , it was submitted more than eight months before, on september . papers such as the nature article marked a major advance in human knowledge of the h n virus. his group, guan said, had contributed at least % of the data on the h n influenza virus in genbank, the database produced and maintained by the national center for biotechnology information as part of the international nucleotide sequence database collaboration. it is certainly a tribute to hong kong, both to the government and to researchers in academia, that while h n is now endemic in mainland china, there has to date not been a single local case in hong kong. how was hong kong able to keep h n at bay? the answer lies in the interventions to reduce zoonotic and pandemic risks. one important step is the closure of live poultry markets. such closures stopped h n outbreaks in the mainland, but they were costly to the poultry industry. the closure of wholesale and retail markets in shanghai, hangzhou, huzhou and nanjing in is believed to have cost the poultry industry about us$ billion. but there are also steps that can be taken short of shutting down the markets, steps that had proven effective in hong kong, such as rest days, when the markets are closed for a thorough cleaning, and banning of live poultry being kept overnight in live poultry markets. separation of live ducks and geese from chickens can also reduce the risk of intermingling of different forms of viruses. one problem in countering the h n virus is that the industry has little incentive to take any steps to detect its presence since the virus doesn't sicken birds, only its human hosts. another measure taken by hong kong is a ban on holding poultry overnight in live poultry markets. this way, incoming chickens are not in the market for long enough to be newly infected and, in turn, infect other birds. other steps include the removal of fecal matter, drinking water and poultry feed because viruses survive longer in water than on surfaces. cages, too, need to be cleaned regularly and should be made of materials easily cleaned, such as plastic, not wood or bamboo. such measures, proven to work in hong kong, can usefully be adopted elsewhere, such as in mainland china or vietnam. because the scene of action of the h n virus was initially not in hong kong, the hong kong research teams established collaborations in the "hot spots" in china. k.y. yuen and his collaborator, professor honglin chen, flew to see their mainland collaborators to get clinical data from infected patients, the virus strain for full length sequencing, tissues from dead patients and, most importantly, virus strains from the wet market poultry. the first paper on h n proving the link between human cases of h n virus and poultry h n virus in the markets was published in the lancet. yuen and his team, in another paper, showed that normal blood donors don't have anti-h n antibodies whereas more than % of poultry workers were antibody positive to h n . this further confirmed the link between h n in humans and h n in poultry. a review article was published in the lancet comparing h n bird flu in hong kong in and h n in shanghai years later. crossing the species barrier from bird to human was previously unknown to medical history. the paper was called "the emergence of influenza a h n in human beings years after influenza a h n : a tale of two cities." as the authors noted, hong kong and shanghai are located along the avian migratory route at the pearl river delta and yangtze river delta. they ended with the observation: "why h n seems to be more readily transmitted from poultry to people than h n is still unclear." malik peiris and hui-ling yen went to shanghai and worked with researchers there on studying patients with h n disease. in a collaborative paper in lancet, they reported the emergence of oseltamivir resistance in some patients that was associated with treatment failure and poor clinical outcome. the h n outbreak also saw the beginning of much closer collaboration between the university of hong kong and the chinese center for disease control and prevention (china cdc). actually, the two institutions had collaborated previously, for example, on a study of hand, foot and mouth disease in china during the - period. shortly after the chinese government announced the emergence of the new h n avian flu disease, hongjie yu, director of the china cdc's division for infectious diseases, contacted dean gabriel leung on his cell phone to discuss the situation. the dean immediately flew to beijing with a group of about ten hong kong university specialists, including ben cowling and joe wu, and stayed there for about a month to take part in making an initial risk assessment on how easily the virus spread, its severity, control measures, the characteristics of the virus, and so on. after a month, the two sides published a series of papers led by gabriel leung as senior author, in which scholars from both sides participated. from to , the h n outbreaks came in annual waves, and specialists from the china cdc and hku studied each one closely. one article, published by the lancet online on june , with hongjie yu as the lead writer, was an assessment of clinical severity of human infection with avian influenza a (h n ) virus. it concluded that human infections with avian influenza a (h n ) virus "seem to be less serious than has been previously reported." it also said that "many mild cases may already have occurred," thus lowering the mortality rate even more. another article, published by lancet online the same day, had ben cowling as the lead writer. it compared the epidemiology of human infec-tions with h n and h n in china. the fatality rate on admission to hospital was % for h n and % for h n , meaning that there was a lower death rate among the older h n sufferers than for the younger victims of h n . the authors acknowledged that the difference in susceptibility to serious illness with the two different viruses remained unexplained. they also collaborated anew on hand, foot and mouth disease, writing a joint paper that provided scientific evidence to support the chinese government's policy of vaccination. a later paper was on hepatitis a and hepatitis e in china. the collaboration between hku and china cdc went so well that a memorandum for cooperation by the two sides was signed on august , , providing for such cooperation to continue for the next years. the purpose was to "improve and enhance the capacity of understanding, surveillance and control of infectious diseases in china" as well as to develop training programs for people from both sides. the two parties agreed that their collaboration would include research projects on infectious diseases; reviewing and evaluation of the infectious disease surveillance in china and seasonal influenza and avian influenza h n and h n . hongjie yu, director of china cdc's division for infectious diseases, confirmed that hku experts, such as gabriel leung, ben cowling and joseph wu, were very helpful to china cdc in the study of emerging infectious diseases with potential pandemic threat and risk assessment. he said: "we have already set up a collaborative platform in this field and definitely will be working closely together to monitor the current outbreaks of emerging infections diseases (eids) like avian influenza h n , h n etc. and to respond to future eids as well." the surgeon general of the united states, william stewart, is frequently quoted as having said in : "the time has come to close the book on infectious diseases. we have basically wiped out infections in the united states." whether he said it or not is now immaterial. the fact is that infectious diseases have not been wiped out, and the world needs to be ever alert to new threats. as for what constitutes modern outbreaks, keiji fukuda has an intriguing observation (fig. . ) . "modern outbreaks are not disease," he said. "in textbooks you read about disease. modern outbreaks are combinations of disease and anxiety, disruption; when you have something like sars, there is a huge amount of anxiety. in beijing there was a day when there was virtually no car traffic at all, the entire city was at a standstill-that was not disease. that was fear of the disease." he continued: "i think if we look back in history, in the epidemic, we can see where fear and actual disease are commensurate; - million people died around the world, like black plague in the middle ages. but with sars and bird flu, we're not talking about millions of people dying and yet we're talking about that level of fear, almost paralysis. managing the disease aspect is relatively easier than managing the fear aspect." despite books and movies about existential threats to the human species, experts are guardedly optimistic when speaking of whether future influenza pandemics are inevitable. dr. peter palese, a flu expert at the mount sinai school of medicine, points out that human flus can infect people who inhale only one to ten virus particles, but it takes , to a million particles of an h bird flu to infect a human. "that's why people who live under chickens in markets in asia get it, and we don't get it on fifth avenue," dr. palese said. more than a decade ago ken shortridge pointed out that hong kong had stopped the h n virus in its tracks three times through surveillance, surveillance, surveillance. "i have no idea if h n will cause a pandemic," he said. "we can't be certain at all." he did warn that h n was in a "smoldering phase" of evolution, similar to that undergone by the virus before the influenza pandemic broke out. but he traced the root of the problem to people, not birds, saying: "the industrialization of poultry is the nub of this problem. we have unnaturally brought to our doorstep pandemic-capable viruses. we have given them the opportunity to infect and destroy huge numbers of birds and … jump into the human race." he went on: "something is not right. human population has exploded, we are impinging on the realms of the animals more and more, taking their habitats for ourselves, forcing animals into ever more artificial environments and existences." so hong kong has a need to remain vigilant, not only for itself but for the world. besides, infectious disease expertise has undergone a major transformation in the last two decades. when bird flu struck hong kong in , the territory was dependent on external expertise to cope with that disease. over the intervening years, researchers at hong kong university have become leading global experts in their own right. the lessons of bird flu and sars have been well and truly learned. hong kong has grown and matured through those difficult days. its research-based control efforts benefit the nation and the global community. as angus nicoll has observed, hong kong does fast as well as high quality research and does excellent epidemiological work, from which the rest of the world can benefit. interview with fukuda. cdc lab analysis suggests new coronavirus may cause sars reassortment of pandemic h n / influenza a virus in swine long-term evolution and transmission dynamics of swine influenza a virus hemagglutin-neuraminidase balance confers respiratory-droplet transmissibility of the pandemic h n influenza virus in ferrets comparative epidemiology of pandemic and seasonal influenza a in households the epidemiological and public health research response to pandemic influenza a(h n ): experiences from hong kong the effective reproduction number of pandemic influenza: prospective estimation hyperimmune iv immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe influenza a(h n ) infection convalescent plasma treatment reduced mortality in patients with severe pandemic influenza a (h n ) virus infection the infection attack rate and severity of pandemic h n influenza in hong kong school closure and mitigation of pandemic (h n ) , hong kong dissemination, divergence and establishment of h n influenza viruses in china interventions to reduce zoonotic and pandemic risks from avian influenza in asia effect of closure of live poultry markets on poultry-to-person transmission of avian influenza a h n virus: an ecological study human infections with the emerging avian influenza a h n virus from wet market poultry: clinical analysis and characterisation of viral genome avian-origin influenza a(h n ) infection in influenza a(h n )-affected areas of china: a serological study the emergence of influenza a h n in human beings years after influenza a h n : a tale of two cities association between adverse clinical outcome in human disease caused by novel influenza a h n virus and sustained viral shedding and emergence of antiviral resistance hand, foot, and mouth disease in china, - : an epidemiological study human infection with avian influenza a h n virus: an assessment of clinical severity comparative epidemiology of human infections with avian influenza a h n and h n viruses in china: a population-based study of laboratory-confirmed cases routine pediatric enterovirus vaccination in china: a cost-effectiveness analysis changing epidemiology of hepatitis a and hepatitis e viruses in china cooperation agreement between division of epidemiology and biostatistics, school of public health, li ka shing faculty of medicine, the university of hong kong, and division of infectious diseases, the chinese center for disease control and prevention in key: cord- - mxkfvvu authors: de leeuw, evelyne title: from urban projects to healthy city policies date: - - journal: healthy cities doi: . / - - - - _ sha: doc_id: cord_uid: mxkfvvu a definition of projectitis (also known as ‘projectism’) is proposed to describe a key barrier to full deployment of a healthy city vision and values. this chapter argues that to put health high on local social and political agendas necessarily means to transcend project-based work, and move into lasting programme and policy development. the conditions for such approaches are favourable in healthy cities, as a number of glocal (global and local) developments invest and sustain longer term perspectives. these conditions include emphases on policy diffusion, social justice, a better understanding of complex systems, and global commitments to the development and implementation of health in all policies. these efforts, in turn, are grounded in renewed and tangible support from universal health coverage and primary health care, asset-based community health development, and better insights into what drives (health) equity and economic development. in describing these elements of policy development for value-based healthy cities the chapter also gives a firm argument for a broad range of stakeholders to engage successfully in longer term policy change. the urban health world is rife with projects-to alleviate poverty, empower communities, provide better roads, increase access to education, secure primary care, etc. many of these initiatives, rightly, have a fixed life. a new school needs to be built; upon completion it requires staff and maintenance: these are entirely different things that can be managed well on a project basis. but a proper policy would take a longer term perspective that includes not just the building and maintenance of the infrastructure. such a policy would set parameters to how infrastructure relates to continued access, how both of these relate to the delivery of a curriculum, and how to undertake regular reviews of accomplishments. goumans and springett ( ) have identified that many healthy cities suffer from projectism. interestingly, although this term (alternated with 'projectitis') has become an integral part of the vernacular of the-critical-government bureaucrat, we have been unable to ascertain an authoritative definition for it. in development studies, pareschi ( ) and little ( ) refer to projectism when they describe the tendency of the international development community (the 'do-gooders' (christensen ) in development aid) to impose a project format with defined beginning and end, contained resources (money, people) in time and space, on daily activities undertaken by indigenous communities that by their very nature are organic and ongoing, e.g. the defence of territory, production of food, and political organization. such project 'containment', they assert, can provoke major changes in cultural values, leadership patterns, time conceptions, organizational structure, and political relations in affected indigenous communities. true as this may be, the popularity of projectism/itis suggests that the phenomenon may have detrimental effects in high-income, industrialized nations as well. a definition that reaches beyond indigenous culture into (western) bureaucratic and political values might read 'the reflex, intention and action to contain organisational and community efforts in terms of resource allocation, time, space and conceptualisation purely for the sake of accountability and management purposes, not because the effort at hand necessarily lends itself to such limitation'. goumans and springett ( ) have investigated the potential of healthy cities to move beyond projects and projectism, and found that ample opportunities exist to move into longer term programmes or policies that embed the value base and strategic outlook of the approach. in this chapter we take a look at the conditions that may facilitate such a longer term endeavour. some research suggests that achieving policy innovation, which is required for introducing systemic and sustainable intersectoral perspectives across society, cannot be achieved at the national level, or not at that level alone. policy diffusion researchers (e.g. shipan and volden ) argue that local governments drive policy innovation and diffusion of novel policies horizontally to other local governments, and vertically to regional and national governments. for example, policy diffusion facilitated the netherlands' efforts to develop a broad healthy public policy in the s (de leeuw and polman ) . global commitments, such as the kyoto protocol for climate change adaptation and mitigation or the framework convention for tobacco control, can be seen as crucial benchmarks for the need to develop new policy types. policy innovation does not happen exclusively bottom-up or top-down, but must be characterized as happening through a process called 'mixed scanning' (etzioni (etzioni , in which systems of incremental and reciprocal checks and balances between governance levels create opportunities for change. a key term that has been encountered throughout this book is 'glocal'. 'glocal health' (de leeuw ; de leeuw et al. ; kickbusch ) is a term used to recognize and appreciate the intricate and inseparable interface between global developments (e.g. climate change or trade) and local responses (e.g. councils adopting building codes that account for the increased risks of flooding and heat islands, or offering favourable opportunities for local entrepreneurship to engage in international forums). this glocalization dynamic is reciprocal. less likely or desirable global developments may be mitigated-or exacerbated-by local action. for instance, the increasing number of local governments around the world adopting 'zero-carbon emission' policies (e.g. koehn ) not only contribute to possible reductions in climate change risks, but also send signals to their colleagues, at local as well as higher government levels, that such actions are feasible and effective. through policy diffusion these local policies impact on global change. in fact, analyses of local government efficacies in the late s and early s led to the introduction of the terms 'glocal' and 'glocalization' into our vocabularies (swyngedouw ) . virtually every development and phenomenon in healthy cities has glocal dimensions. so why would we make policy at all? healthy people are an important resource for society. healthy communities are thriving communities, not just in economic terms (because they may more comprehensively contribute to building their common resources) but certainly also in terms of social development and the resilience to cope with shifts and challenges in their social and natural environments. societies and communities with high levels of positive health are resilient. they can face adversity better. a firm expression of the nature of such a health perspective is often found in its definition as engrained in the constitution of the world health organization ( ): health is a state of complete physical, mental, social [and spiritual, larson ] wellbeing and not merely the absence of disease or infirmity. in spite of this broad framing of health, in many countries the health service delivery (or 'sick care') sector is not fully embracing these views and their consequences. most healthcare establishments focus on individual treatment and disease prevention, and are challenged to adopt a full social model of health. around the world, the health delivery industry has become a dominant economic sector in its own right and efforts to involve it in actions to promote community health (rather than cure and prevention of disease) face strong beliefs that individual-focused interventions are better, quicker, or more effective. the microbiologist-philosopher dubos ( ) recognized the profound interface between individual and social health and defined health as the expression of the extent to which the individual and the social body maintain in readiness the resources required to meet the exigencies of the future. the key to appreciating this definition is the notion of 'the social body': it refers to community as well as society and its institutions. the institutions can be seen as tangible 'hardware' (hospitals, transport services, bodies of government) but also in a more sociological sense. the formidable ahrendt ( ) saw an institution as 'a body of people and thought that endeavours to make good on common expressions of human purpose'. this idea of an institution (as in 'the institution of marriage' rather than 'the hospital institution') has intimate relations to concepts of government and governance. the ways in which local governments are shaped are functions of both the philosophical and structural views of institutions. in democratic traditions, the assumption is that local government can directly represent constituents and respond to individual, family, community, and neighbourhood needs. but that assumption is firmly based in other assumptions about representation and eligibility of people to partake in the communal and political processes leading to the values that pervade governance, and the resulting shape of government. a key aspiration of modern glocal government is to deliver justice. as spinoza ( ) said, the ultimate end of the state is not dominion, nor restraint by fear, nor the exaction of obedience; on the contrary, its end is to free every man from fear, so that he may live securely. contrast this with ronald reagan's definition of government as like a big baby-an alimentary canal with a big appetite at one end and no sense of responsibility at the other (adler , p. ) and the clash of political ideologies will be clear. governments can secure and facilitate different forms of justice (e.g. ruger ): • procedural justice-decision-making about policy, programme, service design, and delivery-making the composition of decision-making bodies more descriptively representative of the community (in cultural, socioeconomic, gender, etc. senses); and strengthening communities' power to define 'agenda' items independently of the 'dominant culture' • substantive justice-influence-putting items on the agenda, influencing discussion and debate on all agenda items, and influencing the outcomes of decision • distributive justice-ensuring that the population has equitable opportunities to access social resources including high-quality health care, but also preventive services and education, employment, transport, etc. we assert that local government is an expression and instrument of priority setting for shaping the resources for health that dubos describes, and creating the forms of justice that allow people to fully participate. this happens through policy development and the management of social and environmental assets. the growing body of evidence, over recent decades, on the social, political, and commercial determinants of health may well enable local government better than other levels of government and governance to take decisive action. evidence from the other chapters in this book shows that local governments (and especially healthy city ones) are in closer contact with their constituents and would purportedly be able to respond more effectively and quickly to needs expressed. clearly this is an idealtype description: not all local governments are transparent and accountable, and not all people may be, or may feel, represented. this is particularly true for slum dwellers. sometimes urban inequities are literally hidden-in many third world cities the slums and their informal populations are located in gullies and ravines. but in others, the favelas rise up high on the slopes surrounding affluence. it appears that technology can come to a degree of rescue, whether it is enabling social connectedness in nairobi slums (corburn and karanja ) or physical connectedness through novel public transportation solutions in medellin, colombia (díez et al. ) . local government also has the potential to address the wider determinants of health and health equity. the determinants of health extend far beyond the workings of the health care system, and include the provision and levels of education, the availability of work and employment and standards, the quality of the built and natural environment, the existence of intangible things like a sense of community and solidarity expressed in 'social capital', and the apparent immutability presence of general social gradients between those at the highest and lowest ends of the socioeconomic spectrum. families and communities, and their elected representations in local governments, most directly suffer and enjoy the negative and positive consequences of their decisions on how their lives are shaped in all these domains. complex and connected issues require complex and integral responses. local government does not stand alone in this-it can respond (and has responded, e.g., through the healthy communities and healthy cities networks) more efficaciously to population needs; but at the same time it is bound by regional (provincial, state) and (inter)national contexts. horizontal and vertical collaboration and synergy can and should be sought. analyses of the workings of modern society and its institutional structures (governance, democracy, leadership, etc.) have shown that traditional sectoral and vertical (top-down) responses may yield short-term success but may not address the systemic and complex causes of problems. the consequence of such analyses has been a call for better integration of (and within) problem formulation, policy development, and comprehensive action. such integration would assume equitable access of highly heterogeneous stakeholders to all elements of enormously multifaceted systems (anyone should have access at any time wielding the same influence over the process, no matter who and where they are-a utopian ideal). it is no wonder that solving this issue has eluded politicians, scholars, practitioners, and communities. at an abstract level, the solution has been found in concepts such as 'systems thinking', 'complexity science', and identification of problems as being 'wicked', 'messy', or 'fuzzy'. for policy-making, those terms have translated into perspectives on 'whole of government', 'joined-up government', 'integral government', and 'horizontal government' (carey ; carey and crammond ; pollitt ) . there is a strong argument to be made that these perspectives play out best at the local level because it is there that cooperation between state, market, and civil society actors is considered most likely to produce coordinated planning and action (christensen and laegreid ) . the search for whole, joined-up, integral, or horizontal local government approaches achieved momentum, some scholars and politicians claim, since the (perhaps overly zealous) adoption of 'new public management' (npm) principles from the s. in npm citizens are viewed as customers, and public servers/administrators are considered managers of product and service delivery. the assumption of npm was that marketization of public goods would yield greater efficiencies. however, vulnerable, socially excluded, marginal, and under-represented populations in particular often cannot claim a voice of influence and power in this pseudo-economic discourse. governments have tried to repair the resulting gaps in the system with the application of (often cunningly rhetorical) tools that go by monikers such as 'new social partnerships' and 'empowered clients'. in many cases a new balance between complete state control (the 'nanny state' caring for everyone 'from cradle to grave', cf. rivett ) and full dissolution of services to commercial sectors is yet to be struck. in the health field, the recognition of 'health' as an issue across social and government sectors has led to the launch of policy perspectives such as 'healthy public policy' and 'health in all policies'. in action terms (that is, for specific intervention development) we have seen the emergence of terms like 'strategic', 'comprehensive', 'multisectoral', or 'intersectoral' action. in the scientific literature we see important efforts to distinguish between all these terms. analysts also suggest ways in which they interrelate. a canadian publication (gagnon and kouri ) starts this discussion with a description stemming from australia of 'integrated governance': the structure of formal and informal relations to manage affairs through collaborative (joined-up) approaches which may be between government agencies, or across levels of government (local, state and commonwealth) and/or the nongovernment sector. this describes the overarching principles driving both policy and intervention responses to complex systems issues in health development: managing health, health development, and health equity through collaborative approaches. the current perspective on health in all policies (hiap) finds a basis in the call to develop healthy public policies in the ottawa charter ( ). around the world, governments at all levels have experimented with integrated health policies. some of these actually inspired the pronouncements of the ottawa charter, e.g. the norwegian farm-food-nutrition policy, the chinese 'barefoot doctors' programme, and women's health initiatives in the americas. two initiatives from opposite ends of the world started the developmental process of what now is called hiap. one came from finland during its presidency of the european union in : finland, building on its experience in the long-running north karelia project (labelled a 'horizontal health policy'), urged other members of the union to engage in a horizontal, complementary policy-related strategy contributing to improved population health. the core of hiap is to examine determinants of health that can be altered to improve health but are mainly controlled by the policies of sectors other than health. (ståhl et al. ) the other came almost simultaneously from the government of the state of south australia, which identified opportunities for a broad policy programme to invest in the health of its people: health in all policies aims to improve the health of the population through increasing the positive impacts of policy initiatives across all sectors of government and at the same time contributing to the achievement of other sectors' core goals (ståhl et al. , quoted in baum et al. rudolph et al. ). these provided impetus for the organization of the eight global conference on health promotion where a statement and framework were adopted that expressed hiap as follows: health in all policies is an approach to public policies across sectors that systematically takes into account the health implications of decisions, seeks synergies, and avoids harmful health impacts in order to improve population health and health equity. it improves accountability of policymakers for health impacts at all levels of policy-making. it includes an emphasis on the consequences of public policies on health systems, determinants of health and well-being. (world health organization a, b) in different countries and jurisdictions the emphases of the different dimensions of hiap vary. consistently, values (in bold) associated with the concept centre around the importance of collaboration between sectors of public policy-making in good partnership. other aspects where less coherence exists between the different jurisdictions include health equity, the attainment of synergy, hiap leading to or driven by accountability, the character of innovation, ways of integration, and the very nature of policy, e.g.: health in all policies is a collaborative approach that integrates and articulates health considerations into policy making across sectors, and at all levels, to improve the health of all communities and people. health in all policies is a collaborative approach to improving the health of all people by incorporating health considerations into decision-making across sectors and policy areas. (california health in all policies task force) health in all policies is the policy practice of including, integrating or internalizing health in other policies that shape or influence the [social determinants of health (sdoh)] … health in all policies is a policy practice adopted by leaders and policy makers to integrate consideration of health, well-being and equity during the development, implementation and evaluation of policies. (european observatory on health systems and policies) health in all policies is an innovative, systems change approach to the processes through which policies are created and implemented. (national association of county and city health officials) (from rudolph et al. ) shifts like these don't just happen. they are the result of, and embedded in, intricately connected webs (kickbusch ( ) identified those for the health promotion endeavour as rhizomes) that grow, dissolve, reconnect, and interact between people, agents, and events. callon ( ) and latour ( ) based their actor-network theory (ant) on such a view of social, policy, and technology development. this is not the place to engage in a fully fledged ant analysis; instead we will list six keystone developments that made the current momentum for hiap possible. one foundation and lasting contribution to our thinking about health in all policies has been the drive towards primary health care (phc). at the who/unicef conference on primary health care in alma ata in , the concept was defined (unicef and who ) as essential health care based on practical, scientific and socially acceptable methods and technology. it is made universally accessible to individuals and families in the community through their full participation and at an affordable cost to the community and country. in its further development, phc became more fine grained, and two perspectives emerged. one was a horizontal (comprehensive, systems-driven) approach aligned with a set of strong values around equity, participation, and community-driven bottom-up action for health and well-being, and the other a vertical (disease and health care-driven) approach aligned with the need to address specific (burdens of) disease in many countries, and grounded in existing institutions and patterns in the delivery of clinical interventions. ideology-inspired debates have raged, contrasting the superiority of each approach. reviews show that vertical programmes, particularly those targeting infectious disease morbidity, may yield short-term and specific health gains (e.g. from vaccination campaigns), but that long-term population health development (e.g. aiming at the reduction of the incidence of non-communicable disease [ncd]) does not unequivocally benefit from such selective approaches (e.g. magnussen et al. ) . vertical programmes work for particular threats, and horizontal programmes contribute to general well-being. in particular, addressing health equity and ncds does not align well with a selective, vertical approach. evidence has emerged that, depending on the existing health profile and management of (social) determinants of health in different communities and countries, an appropriate balance between the two should be struck. building on a mix between vertical and horizontal primary health care, the aspiration should be to engage in the development of comprehensive health strategies accessible to all (rasanathan et al. ). in north america, planning emerged as a discipline early in the twentieth century. initially the planning professional focused on urban development, but soon social planning and other areas such as health and environmental planning were added to the repertoire of the planner. considering the 'best' ways of planning, experts before long found that the full participation of people in planning considerations was important. what 'full participation' entailed was (and perhaps continues to be) a matter of debate, and arnstein's 'ladder of participation' as well as davidson's 'wheel of participation' have contributed significantly to insights into the circumstances and degrees of public participation in the planning endeavour. these views have also made a significant contribution to public health and health promotion practice around the world (wallerstein ) , in the americas (wallerstein and duran ) , and in european healthy cities (boulos et al. ; green and tsouros ) . a second tradition in this arena was driven by paulo freire's work in the area of community development through new forms of education, famously called 'the pedagogy of the oppressed' (originally published in in portuguese, translated into english in ; his politics of education ( ) gives a good reflective overview). the views espoused by freire and others in this tradition hinge on a philosophy that all in society should be able to engage with personal and social development equitably, through open forms of democracy and decision-making. in order to attain such a capacity, empowerment was, and remains, a key strategy in (local) (health) development. others have taken this important work as a starting point for, for instance, assetbased community development (recognizing that the people in particular social contexts are an important resource for change), deliberative democracy, and a particular form of the latter, participatory budgeting. the 'father of asset-based community development' is john mcknight. he sees community assets as all the potential resources in a community-not only financial, but also the talents and skills of individuals, organizational capacity, political connections, buildings and facilities, and so on (kretzmann and mcknight ) . some authors (e.g. page-adams and sherraden ) criticize such a broad conceptualization as assets might be taken to mean 'all good things', and in order to make assets more tangible they prefer to frame them in a more economic manner. such a view denies, in our view, the fact that social and health equity both depend on much more than financial and resource capability, and also involve culture, history and heritage, and context (wilkinson and pickett ) . the asset model presented by morgan et al. ( ) aims to redress the balance between evidence derived from the identification of problems to that which accentuates the positive capability to identify problems jointly and activate solutions, and so promotes the self-esteem of individuals and communities and leads to less dependency on professional services. this can lead to an increase in the number and distribution of protective/promoting factors that are assets for individual-and community-level health. the asset approach should be seen as the 'shiny' side of the coin. the deficit approach remains valuable in responding to acute crises (at individual, community or societal levels), but in evidence terms at least, the asset model may help to further explain the persistence of health and well-being inequities despite increased efforts to do something about it. harrison et al. ( ) have defined health assets as resources that individuals and communities have at their disposal and that protect against negative health outcomes, or promote health status. these assets can be social, financial, physical, environmental, or human resources (e.g. education, employment skills, supportive social networks, natural resources) (harrison et al. ). as such, a health asset can be defined as any factor or resource which enhances the ability of individuals, groups, communities, populations, social systems, or institutions to maintain and sustain health and well-being and to help to reduce health inequities. these assets can operate at the level of the individual, group, community, or population as protective (or promoting) factors to buffer against life's stresses. obviously a balance needs to be struck between the intangible assets (skills, knowledge, intents, and aspirations) and the hardware assets of a community (schools, work, infrastructure, etc.). even when both are available there may still be a disconnect between the two: individuals, families, and communities may want to improve their health, but insidious factors such as (health) literacy, culture, sexism, and racism may stand in the way of full and equitable access and use. an asset-based health approach should carefully take into account all elements of a complex individual, social and ecological environment. effectively mobilizing and empowering communities for their health, health equity, wealth, and well-being is an inherently political enterprise and may upset the status quo. not all governments, locally or nationally, may see the full benefits of participation and empowerment. the maturity of government and governance styles as well as patterns of accountability, transparency, and responsiveness to need may not always allow for the full mobilization of community assets. we will return to these challenges later in this chapter. due to a growing recognition that health lifestyle change through traditional behavioural (health education) interventions had limited efficacy, and needed to be embedded in broader social change, the world health organization with health canada and the canadian public health association organized the first international conference on 'the move toward a new public health' in ottawa, in . the conference, followed by a series of global health promotion conferences, culminated in the adoption of the ottawa charter (world health organization et al. ). the charter defined health promotion as 'the process to enable individuals, groups and communities to increase control over the determinants of health and thereby improve their health'. the conference and its charter saw a responsibility to enable, mediate, and advocate a broad view of health and health action in four areas: • to reorient health services towards a broader, participatory, and health-promoting position in society at any level • to create supportive social, economic, natural, and built environments to create and sustain health promotion and to address the determinants of health equitably • to invest in personal skills and community action to drive and complement these actions • to build healthy public policy, recognizing that health is created across many sectors in society that all have the potential to enhance institutional, community, and personal health reviews of the accomplishments of the ottawa charter have found that substantial progress has been made in our understanding of the drivers of success in each of these fields. our understanding of the complex nature of natural, social, political, and commercial determinants of health has increased, as has our appreciation of the impact of policies on all of these. great advance has been documented in linking ('enabling, mediating, and advocating') individual and community health potential with systemic action on environments for health. the only area where success has been lagging is the reorientation of health services (ziglio et al. ) . the global community of health promoters continues to work on the basis of these principles and advances, and implements these especially in the context of 'healthy settings'-a concept that the charter launched: health is created and lived by people within the settings of their everyday life; where they learn, work, play and love. health is created by caring for oneself and others, by being able to take decisions and have control over one's life circumstances, and by ensuring that the society one lives in creates conditions that allow the attainment of health by all its members. health and economic development go hand in hand, although the interface between the two can best be described as 'fuzzy', or in terms of complex systems policy development 'wicked'. the fact that investment in health is a sound economic strategy started to gain traction from the late s and achieved prominence for the first time in the world bank's world development report investing in health. a strong case was made of the importance to national economies and local communities of addressing health and disease factors that impeded full economic development (jamison ) . the report was criticized for espousing new public management and neoliberal principles of outsourcing and privatizing health as a public good (including, e.g., the supply of safe drinking water) and quantifying the impact of disability on economic development through a measure called the 'disability-adjusted life year' (daly) (e.g. navarro ). however, it succeeded in placing health promotion and public health management on global and local agendas as legitimate strategies for development. the argument for hiap, also at the global level between international bodies, has evolved in the past years with the family of un agencies, including world bank, undp, and who, now mobilized for ncd action. the argument has been developed and refined over the years; for instance, in the jeffrey sachs-led who commission on macro-economics and health. more recently the who commission on social determinants of health (the marmot commission, who commission on social determinants of health ( )) forcefully indicted unequal economic conditions and pervasive poverty as one of the most critical drivers of health inequity around the world. impressively, the global marmot report has had a number of regional (europe), national (e.g. brazil, england), and local (malmø) reincarnations, highlighting the opportunities and benefits of political action on the social determinants of health. in recent years there has also been a move to take the discourse further, with some starting to address commercial and political determinants of health. recently who and undp issued guidance note on the integration of noncommunicable diseases into the united nations development assistance framework ( ), an expression of the joint-agency work that was an outcome of the high-level meeting at the un in which ncds were given utmost priority. in the guidance note the vicious cycle of poverty and health is described with great insight into the implications of this perspective for local government action. the recognition that health is unequally distributed across populations is not new to the twenty-first century. the terminology used for this phenomenon is possibly as political as its causes and consequences. various terms are pertinent to this discourse, including 'health disparities' and 'health differences' (scholars of the unfair distribution of resources and its consequences in society claim that these are deliberately 'value-free' functional descriptors to obscure the political nature of the issue) and 'the social gradient' (the statistical slope between those at the top of a socioeconomic spectrum and those at the bottom) upon which most health and disease expressions can be mapped. (in)equality, some say, is purely a description of that social health gradient, whereas (in)equity conveys a view of the moral and social injustice of such differences in society. wilkinson and pickett ( ) describe how equitable societies provide and create better opportunities for health for all, including enhanced economic development, sustainability, and educational attainment. striving for equity is not necessarily a requirement or prerogative of national government alone-it depends and thrives on a vibrant civil society and its political representation, extending from local action to global policy and the other way around. equity is a driving concept in various global strategies, including those on climate change, sustainable development, and gender. particularly in the health domain, the work by the marmot commission has been instrumental. its report reviews the causes and consequences of health inequity, and demonstrates that it is possible to close the gap within a generation. policy and action at every level are required to mitigate the possible negative influences of globalization on equity; some authors, however, also allude to the significant potential that global connectedness through new social media may have on an equity agenda. the idea that we live in a globalized world has become a mainstream perspective in the twenty-first century. goods, capital, and knowledge travel, sometimes with the speed of light, around the world. globalization goes beyond the bounded role of the traditional nation-state. indeed, although countries continue to collaborate and expand their vision in the globalized world, the phenomenon to no small extent is driven by commercial interests-but also by a new global civil society. the latter includes ngos like greenpeace, médecins sans frontières, amnesty international, human rights watch, and the peoples' health movement. the actions of this variety of actors on the global scene have made the traditional borders of sovereign states more permeable. no country can thrive without interaction, not just with its neighbours but across the globe, and not just with other countries but with such 'non-state actors'. in discussions about global health governance, experts agree that a new architecture for managing health and health systems in this context is very important. at the same time, new technologies and social media offer new opportunities for knowledge development and community mobilization . local governments around the world see the dissolving integrity of the nationstate as an opportunity to take action. the challenges to the sovereign nature of the nation-state have become prominent during (and in the aftermath of) the sars epidemic; authors such as fidler ( ) argue for a new architecture of global health governance (de leeuw ). ncd control, ebola, hiv/aids, the zika and chikungunya viruses, and other health issues have become a global health concern, and new options for policy development at the interface between global and local need to be developed. this has happened through the creation of networks of cities around themes such as climate change and sustainability, age-friendly cities, and knowledge and creativity. assessments of these networks show that such contacts benefit the quality of policy development and actions to improve the quality of life of their citizens. these developments interface with a current discourse about governance. geidne et al. comprehensively review the emergence of the concept of governance as relevant for local health development. they explain that a focus on governance, as complementary to studies of government, derives from a more refined understanding of the scope and nature of the welfare state. this understanding has led to a convergence of ideas that 'government directed by sovereign politicians is not necessarily the most rational arrangement' (geidne et al. , p. ) . stoker ( ) argues that, despite there being no unequivocal definition of governance, a consensus exists that it refers to the development of governing styles that blur the boundaries between, and within, the public and private sectors. this makes governance a multidimensional and contextually relevant approach to local arrangements for health development, but also a phenomenon that can be construed as a messy research problem (e.g. sinkovics and alfoldi ), and 'evidence' for it must be generated in ways beyond the epidemiological paradigm of (quasi-)experimental studies. there is a profound connection between governance and health (e.g. marmot et al. ; plochg et al. ; vlahov et al. ). in a foundation report for the who european region health strategy, kickbusch and gleicher ( ) build on this evidence and argue that there is a difference between health governance and governance for health: ( ) the governance of the health system and the strengthening of health systems is called health governance; and ( ) the joint action of health and non-health sectors, of the public and private sectors, and of citizens for a common interest is called governance for health. the definition of the latter they propose is the attempts of governments or other actors to steer communities, countries, or groups of countries in the pursuit of health as integral to well-being through both whole-of-government and whole-of-society approaches. in many reports and pronouncements the concepts of health governance, health policy, and health action are used interchangeably, especially when they deal with complex intersectoral endeavours. it is useful to distinguish between these, particularly as there is value in seeing an overlapping. intersectoral governance can be defined as the sum of the many ways individuals and institutions, public and private, manage the connections of their common affairs. it is a continuing process through which conflicting or diverse interests may be accommodated and cooperative action may be taken. it includes formal institutions and regimes empowered to enforce compliance, as well as informal arrangements that people and institutions either have agreed to or perceive to be in their interest. (commission on global governance ) in the european region of who, from the early stages of the programme, a commitment to intersectoral governance has been a criterion for designation as a healthy city. from phase ii onwards, cities needed to submit evidence that they had established an intersectoral steering committee (isc) that would oversee policy and intervention development (heritage and green ; lipp et al. ). there are no specific requirements to the design or architecture of such iscs, as they are often driven by unique local contexts and requirements. whether cities lived up to the expectation beyond their formal application commitments was ascertained via annual reporting templates. virtually all members of the network reported that they did establish an isc, although the frequency with which this body met was variable. in some cities it met only once a year, and in others more regularly, up to monthly. in cities where the isc met annually, the role of the body was more at a systems and regulatory level, such as driving and approving policy development and monitoring of intersectoral deliverables; iscs that met more regularly tended to engage more directly in the operational aspects of partnership development, such as allocation of resources and direct supervision of working relationships. both the strategic and the operational aspects of intersectoral governance are important. in their multiple governance framework, hill and hupe ( ) show these different dimensions of governance as complementary requirements for effective and transparent policy development and implementation (fig. . ) . intersectoral governance moves between, and encompasses, an architecture in which implicit and explicit rules at a systems level ('institutional design' in fig. . ) explicitly connect to the way in which individuals in collaborative pro-cesses manage their contacts. since healthy cities in europe have been deliberately considered a natural laboratory of health policy innovation at the local level (tsouros ) , in hindsight it has been appropriate that the specific terms of reference of iscs have never been spelt out in great detail. this flexibility has allowed the emergence of all types of governance, and an evolution of praxis in which these different levels and types of governance have been tried, tested, and connected. regarding the actual architecture of intersectoral governance arrangements in healthy cities, all designated cities are required to have a coordinating office. similar to the flexibility in terms of reference for the iscs, who has not set specific expectations regarding the organizational positioning of this office. there has been an ongoing debate whether this coordinating body should be directly associated with the local government executive office, that is, as a staff unit appended to the mayor's office (fig. . , model a) , or should be a line unit at a relatively high hierarchical level able to coordinate efforts within government (fig. . , model b) . both models can serve a distinctive purpose, depending on the nature and maturity of the healthy city. the evaluation of phase v revealed another type of governance architecture whereby healthy cities increasingly integrate and devolve the responsibility for intersectoral action for health throughout both the government and civil society. intersectoral action is the engagement of relevant sectors, both within and outside the public policy arena, in the implementation of activities, programmes, and projects that have a multidimensional nature. obesity, for instance, has lifestyle-choice dimensions but must also be addressed through structural interventions in the obesogenic environment (kirk et al. ), e.g. in public transport, food security, and community development. ideally this requires a policy and managerial context that embraces the values of hiap described below, and it is important that different sectoral stakeholders collaborate effectively. lipp et al. ( ) show that from phase ii through phase iv of the european healthy cities programme, intersectoral action has expanded and strengthened. for example, the cities participating in both phase iii and phase iv increased the extent of partnership working in all sector studies: health services, social services, education, urban planning, voluntary, environmental protection, transport, and economic development. for phase v, farrington et al. ( ) show that healthy cities, in trying to address the prevention of non-communicable disease, also make explicit efforts to work intersectorally in distal determinants of health. european healthy cities, they find, recognize that to make healthier choices easier requires appropriate structuring of the upstream determinants of health. for example, interventions in the built environment to make active living an easier choice include investment in city sports and exercise facilities, investment in cycling infrastructure, and redesignating streets for pedestrians only. successive european healthy cities evaluations therefore show that local governments are not only embracing intersectoral work through the creation and maintenance of appropriate governance architectures, but are also increasingly deploying resources in terms of operational action to deal with complex problems in dynamic partnerships. following the programme logic of realist synthesis, this suggests that the social determinants of health are being addressed more effectively and sustainably. elsewhere i have argued, with clavier and breton, that 'policy' can mean different things to different actors at the same time. a bureaucrat may use the word 'policy' to indicate 'standard operation procedures', a community activist may mean by it 'a dictate coming from above', and a politician may use the term to denote 'an intention to change'. not surprisingly, the same diversity is found in the field of political science. for the purpose of this chapter, and to distinguish meaningfully between governance, action, and policy, we define the latter as the expressed intent of government to allocate resources and capacities to resolve an expressly identified issue within a certain timeframe (de leeuw et al. ). such an approach clearly distinguishes between the policy issue, its resolution, and the tools or policy instruments that should be dedicated to attaining that resolution. thinking about intersectoral health policy has evolved over the years. healthy cities engage enthusiastically-and beyond mere rhetoric-in the development of health and health equity in all policies. building on a strong foundation in the various political statements on healthy cities over the years and most recently in the athens declaration (tsouros ) , local governments work with diverse stakeholders from the public and civil society sectors to develop such policies. the nearly three decades of healthy city development are clearly leaving a legacy, in that healthy cities manage the politics and logistics of interorganizational work effectively. this is clearly dependent on strong yet flexible governance arrangements and demonstrated commitments to the action component of intersectorality (mcqueen et al. a, b) in the evidence on intersectoral policy development and implementation compiled for european healthy cities (de leeuw et al. ) , there was an interesting mix between more traditional health approaches, such as a programme on active living in izhevsk, russian federation, and initiatives where the health sector has more peripheral ownership, such as a programme on sustainability in amaroussion, greece. this is precisely the message for effective hiap development-that the health sector has the capacity to share, redistribute, and even disavow ownership of policy initiatives beyond its traditional remit. healthy cities show that such actions do not compromise but strengthen the integrity of health sector policy-making capacity. the above developments have created a strong historical footing for the development of health in all policies. they are, however, often seen as abstract global concepts and aspirations rather than operational local inspirations. in this second decade of the third millennium there are, nevertheless, many reasons why local governments and their communities in particular should be inspired to make a real difference. we compile five themes that drive further action. it is important for society and its communities to spend their resources where they matter. although it can be easily contested what 'where it matters' actually means in different contexts (for instance, a national re-election campaign of a politician based in a megacity would probably not recognize the needs of rural and remote communities to their fullest magnitude), this idea has driven the development of evidence-based (health) policy. substantial impact on this broader aspiration was made by the evidence-based medicine mantra that has its foundation in the work of archibald cochrane. he found that many medical practices were not firmly rooted in evidence of effectiveness (whether something produces the intended result) or efficiency (how well it produces that result). the consequence of this position was that decision-makers, both in policy and in practice, invested in approaches to demonstrate the effectiveness of medical procedures. this effort has had its influence on policies that espouse a broad social model of health and health promotion, both globally and locally. the methods to generate evidence of effectiveness on this arena are, naturally, different from the often controlled circumstances under which clinical procedures can be tried and tested. where in clinical environments an assumption is that an experimental group can be matched with a control group, is it much harder in reality to find the perfect experimental match for, for example, a barrio in medellin, in order to test the effectiveness of social investment. yet very good progress is being made in demonstrating the effectiveness and efficiency of health policy and health promotion. evaluation efforts around healthy cities show that it is easier to achieve public participation and good governance for health at the local level. equity is a concept close to the heart of many local politicians. international research shows that health and health equity impact assessments are not just highly effective tools for measuring the consequences for population health of broad social, environmental, and economic change, but also have a significant impact on the quality and sustainability of policy development and implementation. concepts like healthy urban planning that embrace a wider view of transport and mobility show not just health, but far broader social improvement. the ottawa charter for health promotion also launched the ideas of settings for health ('where people live, love, work and play') as a critical aspect of health development. significant evidence has been accumulated on the efficacy and health impacts of initiatives beyond healthy cities, for instance in health promoting schools (globally the most significant network of settings for health with tens of thousands of participating primary and secondary schools, currently expanding into kindergarten environments), health promoting market places, healthy islands (notably in the pacific through the yanuca declaration, linked to the barbados programme of action), health promoting universities, health promoting prisons, and healthy transport. this evidence continues to be compiled by international organizations like who, undp, iuhpe (the international union for health promotion and education), and other global agencies, but also through networks of civil society like international city networks (e.g. c and healthy cities) and academia. there is, in fact, 'metaevidence' that networking for evidence generation enhances the quality, relevance, and responsiveness for glocal action. the enthusiasm and vigour that were originally part of the alma ata declaration on primary health care were rekindled a few years ago when the world health assembly formally re-endorsed the broad social nature of the declaration. it was further sustained by a global campaign to work towards universal health coverage (uhc) at all levels of governance and health system operation. it is defined as ensuring that all people can use the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship (world health organization ). in some instances uhc is conceived as an exclusively financial issue that requires fiscal programmes and discipline to redistribute key social resources. the evidence shows that, in fact, the monetary dimension is maybe the least problematic to address. moving from divisive health (delivery) services towards inclusive ones requires much more than the reallocation of resources. uhc has many benefits and creates ample win-win situations, apart from the obvious health gain. they secure a (human) rights-based perspective on population health, have the potential to organize and rally communities for social and economic development, and have the strong potential for higher quality health information collection and management, thus adding to more bespoke evidence-based local health policy. local governments may not always have control over fiscal opportunities and the management of health facilities and professionals. often these are organized and financed at higher levels of governance, and partly for good reason: not every town needs highly specialized neurosurgeons and expensive fmri scanners. but the essential population-based 'first point of contact' with the health system, i.e. primary care, is by its very nature integrated in local communities-even where there may be no doctor. community health workers and local health posts play critical roles in maintaining and integrating universally accessible and appropriate health and social support; they are also the natural champions of (local) community development. even when there are no formal governance arrangements for local government institutions (and in slum areas may even have an informal nature), these professionals and their operational bases are very much part of the social and political landscape of local government. uhc at point of delivery is therefore a concern for local action, whether it has been formalized as a local government remit or not. experiences from the americas, e.g. of people-centred programmes in mexico and brazil, show that uhc is possible and yields significant dividends, not just for population health but more broadly for social development (quick et al. ). evidence suggests that success of uhc schemes depends on the presence of ( ) the strength of organized progressive groups in local communities; ( ) the potential of mobilizing adequate economic resources; ( ) the absence of significant societal divisions; ( ) a weakness of institutions that might oppose it (such as for-profit hospital enterprises); and ( ) a skilful identification and opening up of windows of opportunity by (local) policy entrepreneurs (mckee et al. ). the description of the social gradient in health (that is, the fact that health parameters like mortality, morbidity, and life expectancy follow the patterns of the distribution of wealth, prestige, status, and education in society) has moved from a mere epidemiological curiosity to a political issue. increasing numbers of governments endeavour to place health equity and its causes high on their political agendas. this happens with varying degrees of success. there have been arenas of governance with such a strong belief in their equitable nature that a debate around the sheer existence of health inequity in those societies and communities has been unimaginable. there are also cases where existing inequity is attributed to personal lifestyle choice rather than to broader determinants of health. this so-called lifestyle drift can be inspired either by uninformed behaviourist tendencies (assuming that all human behaviour is entirely within the control of the individual) or by political ideologies like conservative liberalism (assuming that the fate of societies can be entirely attributed to the resourcefulness of its individual members). the evidence, however, demonstrates that individual choice is determined by social, environmental, cultural, economic, natural, and built environments. clearly these interact in extremely intricate ways. they are also the result of political preference, and of commercial interest. both england's report fair society healthy lives and the swedish socially sustainable malmö stress the interrelation between policies that aim to • give every child the best start in life • enable all children, young people, and adults to maximize their capabilities and have control over their lives • create fair employment and good work for all • ensure a healthy standard of living for all • create and develop healthy and sustainable places and communities • strengthen the role and impact of ill-health prevention one of the most prominent challenges in establishing cross-cutting policies and actions is to move outside traditional disciplinary and sectoral boundaries-silos. how did we end up with, and in, those silos? the classic ideal of a good citizen was that of the renaissance man, of whom perhaps the best example is leonardo da vinci ( - ), the italian polymath, painter, sculptor, architect, musician, mathematician, engineer, inventor, anatomist, geologist, cartographer, botanist, and writer . typically da vinci would not regard himself as any of these 'professions'-he accomplished all of this without silos. and certainly he was not unique-many advances to modern society have been made by men and women who branched out across scientific disciplines and the arts. this comprehensive integration of the sciences and the arts, not just in one person but in a world view, was challenged in the period of enlightenment, in the sixteenth and seventeenth centuries when the world view evolved towards one of a separation of body and mind, and of distinctly different disciplines arguing that the observed world could be understood mainly through rigorous analysis, that is, deconstructing it into its unique parts. scholars started to focus on particular bodies of knowledge and developed strong theories for each. when in the nineteenth century medicine, as one of these disciplines, became highly professionalized (influenced by the industrial revolution and a growing upwardly mobile middle class) these disciplines started to specialize even further. the process is sometimes called 'hyperspecialization' and today can be witnessed in the proliferation of academic journals focusing on quite particular areas of interest. hyperspecialization is one reason that modern societies operate in management and policy silos. professionalization is another. this is the process of establishing acceptable qualifications, a professional body or association to oversee the conduct of members of the profession, and some degree of demarcation of the qualified from unqualified amateurs. the process creates a hierarchical divide between the knowledge authorities in the professions and a deferential citizenry and creates strong patterns of inclusion and exclusion: building a bridge requires an engineering professional, taking someone to court needs legal professionals, and treating disease must involve qualified medical professionals. specialist and professional segregation are continuously challenged. in the early twentieth century, for instance, debate raged in north america whether public health was within the remit of the medical profession. the matter was resolved with the publication of the flexner report (flexner et al. ) , urging a proper 'scientific' approach to clinical medicine teaching, thus excluding public health. in europe-and in countries that followed a european model of health professionalization-medical education continued to include public health matters under the banner of 'social medicine'. specialization and professionalization created formidable commercial and political forces to maintain and protect their status quo. even when the evidence base concerning social determinants of health rationally dictates collaboration and integration of efforts, these forces often prevent successful and effective action and policy development. there is a growing body of rhetorical and evidence-based knowledge that addresses these problems. effective partnering for health starts with the recognition that the capacities of a discipline or specialty in isolation are insufficient to make a difference. the process that enables such a recognition requires the presence of leadership, communication and analytical skills, and something that can be called social entrepreneurship (the capacity to advocate, mediate, and manage opportunities and differences in diverse communities of policy and practice). firm pronouncements by executive offices (e.g. a mayor, ceo, or spiritual leader) in support of reaching out to other sectors are indispensable. reliable and sustainable grounding of such positions in community action helps maintain momentum. such approaches to removing the walls of silos play out at a relatively high level of abstraction; a workforce that is receptive to interdisciplinary work and has been trained to reach out to others is, of course, vital, too. increasingly we see programmes and curricula across primary, secondary, and tertiary education that do in fact embrace such values. the terms intersectoral action (sometimes intersectorial action) and multisectoral action have been part of the rhetorical repertoire of public health and health promotion since the mid- s. the terms achieved credence through the alma ata declaration, the ottawa charter, and a series of other pronouncements by global bodies including who. the international discourse has also included arguments and evidence around variations of ideas about working together for health on the spectrum networking-coordinating-cooperating-collaborating (see lipp et al. for a brief discussion). although there may be conceptual shades of grey around the interpretation of these terms, this focus of public health and health promotion clearly hinges on the noun action. agencies, individuals, groups, and communities may come together to jointly act on health concerns or determinants of health-but this does not necessarily mean that these actions are either driven by policy or result in policy. a series of case studies, however, are starting to build an evidence base that demonstrates that successful intersectoral action may inspire the need for hiap. hiap, however, may not necessarily lead to intersectoral action: for instance, policies to limit lead (pb) content in paints and gasoline are singularly industrial-economic in nature, and apart from commitments required by industry do not necessitate the deep involvement of other government sectors. considering the importance of successful intersectoral action for the development of hiap, it may be worthwhile to reflect on the reasons why it appears such a challenge to break the walls of the silos and move beyond pithy interests. irwin and scali ( ) , at the request of who, assessed the reasons for the failure of intersectoral action and policy to become an 'easy', 'mainstream' effort. they show that intersectoral action for health failed because ( ) it was driven by the health sector alone; ( ) the intersectoral rhetoric was effectively challenged by the absence of supporting empirical evidence and research programmes to establish such evidence; ( ) public health was 'messed up' by new public management ideologies that moved health responsibilities out of government into private and civil society spheres and complicated matters; and ( ) international donors and healthcare agencies achieved rapid success with single disease-focused vertical delivery programmes. it appears that, with the resurgence of primary health care, the strengthening of uhc, and an increasing commitment to equity around the world, the seesaw with neoliberalism and free market principles on one side and deeper human values on the other have become balanced again, and that the political climate for successful intersectoral action initiatives is more positive. this is expressed in the commitment to hiap formation and implementation, but the limitations and challenges in the comprehensive embrace of integral action will remain and need to be addressed. this discussion on the critical connection between action and policy raises the question of what the process to attain and sustain health in all policies will entail, and which actors need to be engaged. mcqueen et al. ( a, b) describe various governance models for hiap. these have been mapped onto the different elements of the policy process ( fig. . ) and hinge on seven best practice models for hiap implementation. different (groups of) government and non-government agencies can play different roles during the hiap process. figure . describes some of the governance parameters for positioning hiap development within government structures. in addition to this, we have also identified eight institutionally different structural interaction patterns (fig. . ) that describe the linkages between the health care system and its public policy agencies (e.g. a ministry of health at the national or provincial level; or a public servant within a local government agency with a public health remit), other public sector agencies and executives (the office eight ways to coordinate between sectors, and implement hiap in integrated or separate action of the president or mayor, for instance), and the shape that intersectoral action for health and health equity may take. it would be an illusion to think that inter-agency integration or collaboration will automatically lead to integrated action. there are many cases where collaboration still leads to a multitude of singular projects without a lot of systemic and synergy consequences. an example might be inter-agency collaboration on road safety: even where there may be agreement on the nature of a road safety issue (e.g. child fatalities) and action is taken, those actions may not be coordinated and sometimes may be counterproductive. road design, improvements, trauma response, safety communications (signage), and behaviour communications (promoting seatbelts and helmets) should be jointly assessed and developed. if they are not, the whole of the roadscape may be messy and confusing and the total effectiveness of interventions significantly decreased. on the other hand, we know examples where the health sector successfully drives systemic and sustainable intersectoral action in cases where the sector is given the opportunity to engage with local communities. an example would be the integration of health checks, childcare, and (health) literacy training in 'casas de cultura' (latin america) or community hubs. key to the success of any approach is the assessment of win-win opportunities, playing to the strengths of each sector and community, 'going with the flow' rather than against it, demonstrating co-benefits to those involved (and that goes beyond government sectors), avoiding turf wars, and a more comprehensive appreciation of different forms of evidence that are generated and applied beyond the health system alone. this includes the exploitation of successful inter/multisectoral action driven by stakeholders outside the health and public sectors. intersectoral action and hiap must not happen for their own sake. collaboration without joint ownership and outcomes, and integrated policy addressing onedimensional issues, is senseless. many lessons have been learned from the integrated partnership agenda in health promotion, particularly in healthy cities (e.g. lipp et al. ) . planned action to connect, integrate, and scope the integral policy agenda needs to address the following evidence-based stages: • map and recognize organizational mission and resource capacities and acknowledge the boundaries of the traditional organizational footprint. • describe organizational challenges in addressing issues and populations that permeate and move beyond the organization's legitimate area of concern. • map and include organizations that cover the same, similar, or different issues and populations, or share the same, similar, or different approaches and interventions to deal with these. • recognize the legitimate potential of other stakeholders to be involved in intersectoral action or integral policy development and strive for transparency in sharing these views. • scope the dimensions of probable and possible collaboration and factors that may stand in the way of respectful joint action. • involve real authorities and decision-makers, including organization executives as well as street-level bureaucrats (frontline implementation personnel who deal with inter-sectoral action challenges on an everyday basis), in shaping the joint agenda. • formalize and celebrate each of these stages, as far as possible including individuals, communities, and neighbourhoods that are at the 'pointy end' of the implementation of action and policy outputs. • make all stakeholders in these processes, as far as is culturally and organizationally possible, accountable for their actions, but apply the 'chatham house rule' (full confidentiality of sensitive and strategic considerations) wherever necessary. in this book we have seen that in many local government areas there are already effective structures and processes that would further facilitate the development of inter-sectoral action for health and a strongly associated integral policy development potential. such structures and processes include • an engaged and empowered community • successful experience in deliberative democratic and participatory processes • successful experience in partnerships and collaboration for health and well-being • a broad recognition of the urgency of ncd strategies, supported at executive and council levels • a broad recognition of the 'causes of the causes' of ill health, supported at executive and council levels • an existing agenda to strengthen or move towards universal health coverage • existing role models and examples of inter-sectoral action and hiap in other local governments in the countries, for instance, connected through healthy communities networks • vertical integration of governance models for inter-sectoral action and hiap between different levels of government • existing evidence of social, economic, and sustainability win-win situations, and ongoing connections with local and national agencies and structures that may support the creation and maintenance of such evidence (e.g. local and national universities and ngos) addressing the complexity of modern health and health equity issues requires a lasting, continuous process. the establishment and implementation of one health in all policy in one place cannot be considered the end point. it is a stage in an evolutionary practice: the policy needs to be reviewed, adapted, and renewed to meet the exigencies that it has created. the context, and local stakeholders, in which this happens will constantly change. political shifts may require a renewal of executive commitment; evolving community concerns will dictate ongoing participatory consultative action; and technological advances may inspire new solutions. the local government apparatus will require a firm grounding in flexible understanding of the foundations of inter-sectoral action and hiap, and the processes required to maintain and develop its potential and impact. the above steps, when documented and conscientiously applied, form a local basis for sustained capacity to address new complex health issues through hiap and inter-sectoral action. a form of 'corporate memory' is required to keep such lessons on the radar, and a public repository (virtual or real) can be such a resource. various organizations, often at the interface of policy and practice, offer capacitybuilding programmes that engage with real-life environments and aim to integrate new understanding and improved potential for sustained change in local health development. one example is the learning by doing programme (harris-roxas and harris ; pennington et al. ) that makes local government agents across sectors engage in, and reflect on, health impact assessments. another example is the efforts of the victoria health promotion foundation (australia) to build capacity for local operators to include broad determinants of health thinking (environments for health) in actual processes towards the development of compulsory municipal public health plans through its 'leading the way' programme (vichealth ). we started this chapter by asserting that many local initiatives merit a project approach with dedicated temporal and resource dimensions. but to drive those projects in an integrated vision they should transcend themselves, transforming into a perspective that connects an overall vision for the future of a glocal issue or environment. we have described how such vision has been given momentum by developments both local and global, firmly grounded in a set of coherent values including equity, participation, sustainability, and accountability. it is not just preferable to work towards policy for health: it is the only thing to do to respond to the needs of communities, and through integrated connections between sectors, in health in all policies. the reagan wit on violence new norms new policies: did the adelaide thinkers in residence scheme encourage new thinking 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health in resettlement: implementation and evaluation of cross-cultural trauma-informed care training date: - - journal: j immigr minor health doi: . /s - - -w sha: doc_id: cord_uid: ocpehls refugee mental health needs are heightened during resettlement but are often neglected due to challenges in service provision, including lack of opportunities for building capacity and partnership among providers. we developed and implemented culturally-responsive refugee mental health training, called cross-cultural trauma-informed care (cc-tic) training. we evaluated cc-tic, using a free listing and semi-structured retrospective pre- and post-training evaluation with five localities in two states in the u.s. the results showed significant improvement in providers’ knowledge of trauma impacts, cultural expressions of trauma/stress-related symptoms, and culturally-responsive trauma-informed care. trauma-informed care specific to refugee resettlement was regarded as the most helpful topic and community partnership building as the most requested area for future training. this study emphasizes that culturally-responsive trauma-informed approaches can help bridge gaps between mental health care and resettlement services and promote exchanges of knowledge and expertise to build collaborative care and community partnership. refugees commonly experience trauma, such as social conflicts and violence, witnessing tragic deaths, torture, forced confinement, and numerous human rights violations [ ] [ ] [ ] , which likely increases risk for various mental health issues and disorders [ , ] . in fact, more than one in four refugees who have been exposed to mass conflict report posttraumatic stress disorder (ptsd), and more than one in four report symptoms of major depressive disorder [ ] . in a recent review [ ] , asylum seekers and refugees reported high rates of depression, anxiety, and ptsd (all up to %), despite variation across settings (e.g., displacement or resettlement, high-or low-income countries). in addition, psychiatric disorders are notable when assessment includes mental illness beyond common mental disorders. in a german study with refugees from syria, iraq, and afghanistan, % of those receiving neurological emergency services reported a non-epileptic seizure or psychiatric disorder, which is much higher than the % prevalence in native germans [ ] . although mental health issues are more prevalent among refugees, mental health care for refugees resettled in the u.s. is sometimes neglected due to multiple challenges in service provision [ ] . the concept of mental health care and psychotherapy are foreign in many refugee communities [ , ] , and mental health is a stigmatized issue in refugee communities [ ] [ ] [ ] [ ] . in addition, service providers face challenges related to lack of capacity for culturally-responsive and -relevant services in many refugee-serving agencies. service providers in human and social services, as well as medical settings, often lack an understanding of refugees' cultural background and unique mental health challenges and needs [ ] [ ] [ ] . additionally, linguistic and cultural barriers keep refugees from accessing mental health services [ ] . refugee mental health interventions are the most effective when they are culturally-and linguistically-sensitive and specific to refugee groups [ ] . however, even refugee resettlement agencies, who may be equipped with better cultural and linguistic competency than most social or mental health services, struggle to recognize and respond to refugee mental health needs. despite these barriers to care, there are few training modules or opportunities that are directly relevant to refugee mental health needs. two well-known training programs available to refugee-serving professionals are training on the refugee health screener (rhs- ) [ ] and mental health first aid training (mhfa) [ ] . rhs- training is provided to refugee nurses who conduct refugee medical screening and to some refugee resettlement staff for referral purposes. although this training can help with early detection of common mental disorders (cmds), the contents are limited to basic screening and do not sufficiently prepare providers to understand and respond to refugee mental health needs. mhfa training has been delivered to refugee community leaders [ ] but has limitations in addressing mental health stigma and building hands-on competencies for service providers in the community because it was developed as psychoeducation for those with mental disorders and their caregivers [ ] . the curriculum is also not tailored to a refugee population, making it irrelevant or even culturally insensitive when it comes to meeting urgent issues of access to care and stigma. additionally, many structured training programs including mhfa are costly and dependent on the availability of culturally-competent trainers who understand refugee contexts or acculturative challenges. sustainable options are needed to ensure that mental health training is affordable and available to refugee service providers in various settings. given such gaps, the authors developed a tailored training program that helps refugee service providers build competencies related to trauma-informed care in crosscultural settings and community partnerships for referrals and coordination of care. the current study aims to identify refugee service providers' mental health training needs and to evaluate the training program in building competencies and providing tools and resources to refugee-serving professionals and refugee community leaders. in order to address the gap in culturally-competent traumainformed care in refugee resettlement services, the first author developed an interactive training curriculum based on herman's trauma recovery model [ ] and substance abuse and mental health services (samhsa)'s core principles of trauma-informed care [ ] . the training curriculum is comprised of two pillars: ( ) trauma-informed care and ( ) culture-informed care. the trauma-informed pillar is based on the idea that trauma can affect entire refugee communities, and interventions must address this trauma across all types of services and care in the community. the cultureinformed pillar is based on the idea that culture influences refugees' trauma experiences and help-seeking; thus, to provide appropriate mental health care, providers must apply or embed culturally-sensitive supports to their services. together, these pillars form the cross-cultural traumainformed approach to refugee mental health and wellness, which aims to guide stratified interventions and services for refugees and to build healing partnership among refugeeserving providers. the cross-cultural trauma-informed care (cc-tic) training was developed based on the first author's psychoeducation manual on trauma and culturally-specific, as well as general, mental health topics in the context of refugee resettlement [ ] . the training, which was delivered over two consecutive days, consists of eight . -h-long sessions, followed by a one-hour reflection and discussion session. the contents involve knowledge building (e.g., mental health terms, refugee trauma and its sequelae, refugee mental health issues, and cultural expressions of distress) and skill building (e.g., psychoeducation, listening skills, systems of care and multi-tiered intervention, community-based interventions, grounding and mindfulness, and self-care). the training contents were slightly modified for each site to meet unique as well as common needs in each locality. for example, a session on integrated care was included when many healthcare providers attended, while more contents on complex trauma were added when the community recruited providers in school settings and family services. the training was delivered by the first author at five sites in two states, over a two-year period, and was hosted by national agencies responsible for state-wide refugee health promotion programs. one site offered the training twice, once in and again in with slightly different topics. table shows the comprehensive list of training topics per locality. of note, each locality has different resettlement patterns. when providing the training, the authors aimed to focus on the major refugee ethnic and cultural groups that each site has resettled. most of the sites have many refugee groups in common, which include afghan, bhutanese, congolese and karen/karenni. after each cc-tic training, participants were asked to reflect on the training experience and assess their competencies retrospectively. retrospective study refers to data collected about interventions or programs that happened in the past [ ] . while retrospective designs may introduce bias based on participant recall [ , ] , they can allow for longer observation periods [ ] , greater generalizability [ ] , and more cost-efficient data collection [ , ] . studies have found that retrospective designs produce adequately valid and reliable results [ ] [ ] [ ] and provide information that may be less objectively true but still important [ ] . we adopted this methodology as it can allow participants to conscientiously evaluate their baseline knowledge and competencies, especially related to new subject matters, by decreasing the possibility of overestimating baseline understanding [ , ] . as such, we used retrospective study to assess participants' pre-and post-test knowledge related to refugee mental health and psychosocial support. we embedded this retrospective pre-and post-training evaluation (rppe) into a mixed-methods design. first, we had participants free list three training needs to explore gaps in capacity for refugee mental health care. then, we used rppe to assess participants' knowledge and skills in refugee mental health before community-based interventions for refugee newcomers importance and examples of community-based interventions different formats and ways to provide community-based interventions self-care and mindfulness self-care: compassion fatigue, burnout and secondary trauma grounding and mindful exercises resources resources for trauma-informed and culturally-sensitive care for refugees and after the cc-tic training. we included seven items measuring core competencies at every site (e.g., refugee trauma and mental health and trauma-informed and cultureinformed care) along with four to five additional topics that were tailored to each training site. along with the structured rppe items, we added four open-ended questions, related to the most helpful topical areas, remaining gaps, applicability of the training, and suggestions for future training. the study was exempted from irb review by the authors' institution as the training evaluation was conducted by the hosting agencies for the purpose of program evaluation and no identifiable information was obtained for the assessment. the cc-tic training aims to improve mental health competencies for not only mental health professionals (e.g., clinical psychologists/social workers and mental health nurse practitioners/counselors) but also non-mental health care providers, including refugee resettlement staff, public health nurses, school liaisons/coordinators, caseworkers, community health workers, and refugee community leaders, volunteers, and interpreters. participants self-reported their profession. they were given response options which were then grouped into three categories: ( ) mental health provider, ( ) refugee resettlement worker, and ( ) the free listing data and open-ended questions were analyzed using conventional content analysis [ ] . participants' responses were grouped into themes and categories, which were compiled to broader domains across the six training localities. for the rppe data, we ran descriptive statistics including demographic variables and frequencies of evaluation items, followed by a series of t tests, correlations and anovas to determine the average change in pre-and post-test scores according to different professions and former training experiences. all the quantitative analysis was performed in spss win ver. . the free listing data is shown in table . we identified six overarching themes in the training priorities listed by the study participants: ( ) refugee interventions and programs, ( ) refugee trauma, ( ) refugee service resources, ( ) refugee resettlement challenges and needs, ( ) provider networking, and ( ) other. of the participants, most ( . %) listed refugee interventions and programs as one of their top three training priorities. most participants ( . %) also reported learning about refugee resettlement challenges and needs as a training priority. table also shows subthemes within each of the six themes. the total and individual-item means for the evaluation data are shown in table , along with the t test results and average change in pre-and post-test score. all t tests were significant at the pre-determined cutoff point of . . for the seven core competency items included in the survey for all six localities, the average change in total core competency score was . (t[ ] = . , p < . ). the pre-test to post-test change in individual core competency score ranged from . (basic mental health terms) to . (multi-tiered model for refugee mental health and psychosocial support. table also shows four of the tailored competencies, each of which was included in at least three localities. analysis of the four open-ended survey questions revealed a set of themes. the most common theme regarding the most helpful contents (n = ) was refugee trauma and trauma-informed care (n = , . %), followed by cultural competency and cultural idioms of distress (n = , . %), and partnership building (n = , . %). others reported mental health symptoms and clinical skills (n = , . %), self-care (n = , . %), and the multi-tiered intervention model (n = , . %) as the most beneficial topics. regarding remaining gaps (n = ), most participants skipped a response or reported that all topics were clear (n = , . %). participants requested extended training on community partnership building (n = , . %), trauma recovery (n = , . %), techniques of mental health assessment and interventions (n = , . %), the multi-tiered programs (n = , . %), and self-care (n = , . %). analysis of the applicable topics and future training needs are detailed in table . table shows the results of a series of anovas comparing the average change in pre-and post-test scores by profession. these results indicated that the mean change in score was significantly different for mental health providers when compared to refugee resettlement workers and other professions for all core competency items except for refugee trauma knowledge. the aim of this study was twofold: ( ) evaluation of the effectiveness of refugee mental health training for refugee service providers and ( ) exploration of needs and challenges in building competencies for refugee mental health. first, the retrospective self-assessment shows how two-day intensive training can build competencies to help understand and respond to refugee mental health needs. though mental health professionals reported significantly higher competencies in overall topics prior to the training, the reflective post-training scores showed marginal differences across professions, and non-mental health professionals attained a good level of understanding in mental health topics and foundational skills that are crucial to trauma-informed services. it is also notable that mental health providers often do not receive professional training on trauma-related topics [ , ] , let alone specifically on refugee mental health. t in fact, mental health professionals reported the low baseline scores on refugee cmds, cultural influences on trauma and mental health outcomes, multi-tiered interventions, and trauma-informed care in this study. although most participants ( %) reported previous mental health training, there was no significant difference in preexisting knowledge of how trauma and culture intertwine to shape mental health and refugee cmds. the amount of previous experience (i.e., time) working with refugees also did not affect training outcomes in core competencies except for self-assessed general confidence prior to the training, which corroborated that work experiences alone do not build competencies in how to respond to refugee mental health needs. this implies significant gaps in currently-available training for refugeeserving professionals and a lack of culturally-responsive and -sensitive mental health training not only for those without mental health backgrounds but also for mental health professionals with formal training and direct practice experience. this study also sheds light on current needs and challenges in refugee mental health training and proposes future suggestions and strategies for building capacity for traumainformed care for refugees in various service settings. knowledge and hands-on skills for refugees with mental health needs were of the highest demand, followed by resettlement-related mental health needs and cultural knowledge to provide culturally-responsive and contextually-relevant programs. reportedly, mental health professionals showed higher competencies in overall mental health knowledge and skills and less understanding of culture-specific needs and resettlement contexts, while refugee resettlement staff and community leaders presented the opposite patterns. though mental health professionals take a critical role in community capacity for trauma-informed care and refugee mental health services [ , ] , the findings of this study also emphasize the importance of collaborative and coordinated care. participating in the training with a heterogeneous group provided insight into refugee mental health supports and situated individual programs in a broader system of care beyond segmented interventions, also helping to overcome pathologization of normal grieving processes and acculturation distress in the refugee community. participants highly valued mutual learning and networking opportunities throughout the cc-tic training, which corroborates the synergic effects suggested by previous training models to promote interprofessional learning [ ] and mutual empowerment through intercultural communication and advocacy [ , ] in community settings. this format promotes a public health approach and the principles of trauma-informed care, which underscores awareness of workshop topics that participants plan to apply to their agency or community trauma responses/trauma-informed care ( . %) "the additional knowledge was useful in that it enhanced a deeper understanding of how best to engage and accommodate families and students coping with trauma and resettlement stressors" "trauma, stress and mental health" "as a caseworker, i need to do better about addressing trauma on a daily basis" community partnerships ( . %) "i would like to see our community develop a better network of service providers" "more partnerships with community" "i am so very excited about the conversations and cross-agency community-building to come" teaching coworkers/staff ( . %) "develop workshop for coworkers, dept., & agency" "i supervise therapists-will take info back & educate them" "i would love to help provide some of this info to our clinicians in small consistent training to improve the mental health care we provide" cultural competency/population-specific information ( . %) "become more culturally sensitive; serve clients with the culture-informed lenses" "i am planning to add contents about western and non-western culture scenario into my agency's presentation curriculum" knowledge about refugee trauma experiences ( . %) "a better awareness of the background of refugee trauma" "refugee trauma and force migration" psychoeducation/community trainings ( . %) "definitely would love to do some psychoeducation and community wellness workshops with residents/clients. i also want to continue connecting with other service provider" "i also want to be able to convey that idea to community members in an approachable way that makes them better understand what refugees have gone through and continue to deal with every day" mental health knowledge ( . %) "common mental disorder in refugee population" "integrating the tiers in the process of mental treatment" community engagement ( . %) "developing trauma-informed care of my agency and be involved in community capacity" "engaging community" sharing workshop resources/exercises ( . %) "potentially considering how to expand capacity for groups and utilizing training manual for training other staff or partners" "the stone and flower exercise" self-care ( . %) "self care…preventing fatigue" "care of self" terminology ( . %) "language that i will incorporate during direct care around trauma and stress" "trauma terminology" listening skills ( . %) "i would like to more actively apply the different listening skills that were discussed" "the exercise of deep listening was very helpful. it was a good reminder that we can soften into the experience and allow the client to simply be witnessed. in a way, it's practicing humility" resettlement policies ( . %) "background on resettlement program history" "improving systems" grounding/mindfulness ( . %) "the grounding technique" "resources…to make sure we know who to go to about various concerns/needs of the refugee population" "communicating and networking to share services" "resources, community network, knowledge of providers" refugee mental health ( . %) "integrated care for refugee mental health psychosocial support" "any topic on refugee health" "anxiety, depression, trauma" trauma-informed care ( . %) "best practices for implementing trauma informed care in a resettlement agency" "trauma recovery and healing" "group work with traumatized refugees/immigrants" examples/application of learning ( . %) "i would love to have a workshop that would allow open discussions and case studies to apply the knowledge we learned from this workshop to actual practice settings" "discussing more real life/like life examples could be helpful" "video/examples of therapy session with interpreter with different techniques" community engagement ( . %) "how to encourage others to engage more with the refugee community & seek to be more involved in serving them. initiating & sustaining programs…especially fiscally" "a training on how to motivate and empower community elders and leaders to continue to practice and share their knowledge and expertise…their involvements in this area has proven to always play a significant part in strengthening community in may ways" community interventions ( . %) "community-based interventions, examples of other states" "i think a cultural competency training for specific populations with teachers and school staff would be an excellent idea and super beneficial for that communication piece" clinical skills ( . %) "trauma focus therapy for mental health providers" "communication skills" "clinical interventions for mental health practitioners who work with survivors of war trauma" cultural competency/issues for specific cultures ( . %) "further information about various cultures; a breakdown of languages, traditions, stigmas, norms, non-verbal/verbal communication, etc" "refugee population specific interventions per cultural/ethnic group (e.g., which interventions have been successful for each population)" "education about specific ethnic/cultural groups" trauma impacts not only in the refugee community but also among caregivers and service providers and emphasizes collaborative care and partnership building across service sectors to overcome challenges in mental health stigma, cultural and linguistic barriers to services, and other psychosocial issues that obstruct mental health care (e.g., transportation, insurance and eligibility, literacy, etc.) [ ] . as previous research points out [ , ] training alone may not suffice to build collaborative care across agencies and service settings. this study shows that capacity-building efforts allow an open platform to discuss common challenges across communities of practice and to reorient gaps in knowledge and skills on an individual level to advocacy and partnership at organizational-and community-levels. regardless of localities, participants were enthusiastic about the idea of providers' networks or partnership meetings to regularly discuss refugee mental health issues despite such challenges as lacking buy-in or internal supports from leadership, few resources for community-wide action, and limited interagency accountability. as a naturalistic evaluation study, this research has some limitations to consider. the study was conducted as part of program evaluation by two state-wide refugee health programs and turned into a case study of five resettlement sites with no comparison groups. follow-up to track how participants retain and utilize training competencies would be beneficial and is the next step of this study. retrospective measures were efficient in this study due to limited selfawareness on unknown topics (e.g., cultural humility); however, future research may consider adopting a conventional pre-and post-test design to assure improvement in competencies over time. also, an in-depth study on how partnerships can be built across mental health fields and psychosocial programs would help design an effective community partnership or coalition model addressing common refugee mental health challenges beyond services working in silo. this study contributes to the field by addressing gaps in knowledge related to mental health training and capacity building in the context of refugee resettlement services. we developed and implemented training on refugee mental health that is culturally sensitive and contextually relevant to service environments, which fills gaps in the field related to lack of appropriate trainings for refugeeserving staff. we have also proposed an innovative training approach that emphasizes mutual learning and partnership building opportunities. the culturally-responsive traumainformed approach helps bridge gaps between mental health care and psychosocial services in current refugee lgbtq refugees & how they can be supported" "incorporating undocumented survivors experience" more in-depth coverage ( . %) "an advanced training on this topic" "future workshops could build further on the knowledge that [the facilitator] shared. she had to skip over a lot of material just due to the time constraints involved" "more in depth discussion of cultural expressions of trauma; bodies' response to trauma ( . %) "how trauma affects physical health" "psychosomatic pain" refugee trauma experiences ( . %) "resettlement stories" "refugee trauma pre and migration" trauma recovery ( . %) "anything that would help refugees overcome their trauma is welcome" "trauma recovery and healing" self-care ( . %) "self-care" "staff trauma and stress management" integrated care ( . %) "integrated care for refugee mental health psychosocial support" grounding/mindfulness ( . %) "i would have enjoyed more physical/relaxation/grounding exercises or movement or interactive exercises" potential triggers ( . %) "potential triggers of body language asking questions etc" resettlement program, which can promote exchanges of knowledge and expertise to build collaborative care and community partnership. table items and mean scores by profession, across sites *p < . **p < . ***p < . a participants self-reported their profession with response options which were then grouped into three categories: ( ) mental health provider, ( ) refugee resettlement worker, and ( ) other (collapsed from the remaining options: healthcare provider, social services, interpretation, medical liaison/community health worker/medical case manager, teacher/provider in school setting, university researcher, refugee program supervisor, refugee community leader/volunteer, community-based organization, or other) psychological distress and adjustment of vietnamese refugees in the united states: association with pre-and postmigration factors the impact of interpersonal and noninterpersonal trauma on psychological symptoms in refugees: the moderating role of gender and trauma type dose-effect relationships of trauma to symptoms of depression and post-traumatic stress disorder among cambodian survivors of mass violence psychological trauma and evidence for enhanced vulnerability for posttraumatic stress disorder through previous trauma among west nile refugees association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis common mental disorders in asylum seekers and refugees: umbrella review of prevalence and intervention studies neurological emergencies in refugees access to mental health treatment by english language proficiency and race/ethnicity knowledge of depression and depression related stigma in immigrants from former yugoslavia this doctor, i not trust him, i'm not safe': the perceptions of mental health and services by unaccompanied refugee adolescents beyond stigma: barriers to discussing mental health in refugee populations barriers to health care access among refugee asylum seekers exploring the "fit" between people and providers: refugee health needs and health care services in mt roskill barriers to care: the challenges for canadian refugees and their health care providers new directions in refugee youth mental health services: overcoming barriers to engagement review of refugee mental health interventions following resettlement: best practices and recommendations the refugee health screener- (rhs- ): development and validation of an instrument for anxiety, depression, and ptsd in refugees mental health first aid: an international programme for early intervention mental health first aid training for the bhutanese refugee community in the united states trauma and recovery: the aftermath of violence-from domestic abuse to political terror substance abuse and mental health services administration: samhsa's concept of trauma and guidance for a trauma-informed approach rockville trauma-informed cross-cultural psychoeducation (ticcp): mental health training for refugee community leaders & mental health care providers (interactive training manual). richmond, va: virginia commonwealth university and virginia department of behavioral health and developmental services synthesis of literature relative to the retrospective pretest design: in: the joint ces/aea conference bias in retrospective studies of trends in asthma incidence social work research methods: from conceptualization to dissemination retrospective studies: a fresh look looking back from death: the value of retrospective studies of end-of-life care panel : methodological issues in conducting pharmacoeconomic evaluations-retrospective and claims database studies psychopathology and early experience: a reappraisal of retrospective reports validity and reliability of a method for retrospective evaluation of chlorophenate exposure in the lumber industry a retrospective survey of childhood adhd symptomatology among adult narcoleptics a retrospective survey of childhood experiences retrospective preevaluation-postevaluation in health design three approaches to qualitative content analysis responses of a sample of practicing psychologists to questions about clinical work with trauma and interest in specialized training the need for inclusion of psychological trauma in the professional curriculum: a call to action promoting mental health and preventing mental disorder among refugees in western countries screening for war trauma, torture, and mental health symptoms among newly arrived refugees: a national survey of us refugee health coordinators interprofessional student meetings in municipal health servicemutual learning towards a community of practice in patient care promoting hmong refugees' well-being through mutual learning: valuing knowledge, culture, and experience cross-cultural training in mental health care-challenges and experiences from sweden and germany bridging community intervention and mental health services research approaching the vulnerability of refugees: evaluation of cross-cultural psychiatric training of staff in mental health care and refugee reception in sweden building capacity to care for refugees acknowledgements we wish to thank all the community partners who supported and organized the refugee mental health training and the program evaluation. this study would not be possible without all the participants who joined the training and shared their valuable opinions and suggestions. key: cord- -dhdyxnr authors: den boon, saskia; vallenas, constanza; ferri, mauricio; norris, susan l. title: incorporating health workers’ perspectives into a who guideline on personal protective equipment developed during an ebola virus disease outbreak date: - - journal: f res doi: . /f research. . sha: doc_id: cord_uid: dhdyxnr background: ebola virus disease (evd) health facility transmission can result in infection and death of health workers. the world health organization (who) supports countries in preparing for and responding to public health emergencies, which often require developing new guidance in short timelines with scarce evidence. the objective of this study was to understand frontline physicians’ and nurses’ perspectives about personal protective equipment (ppe) use during the - evd outbreak in west africa and to incorporate these findings into the development process of a who rapid advice guideline. methods : we surveyed frontline physicians and nurses deployed to west africa between march and september of . results: we developed the protocol, obtained ethics approval, delivered the survey, analysed the data and presented the findings as part of the evidence-to-decision tables at the expert panel meeting where the recommendations were formulated within eight weeks. forty-four physicians and nurses responded to the survey. they generally felt at low or extremely low risk of virus transmission with all types of ppe used. eye protection reduced the ability to provide care, mainly due to impaired visibility because of fogging. heat and dehydration were a major issue for % of the participants using goggles and for % using a hood. both gowns and coveralls were associated with significant heat stress and dehydration. most participants ( %) were very confident that they were using ppe correctly. conclusion : our study demonstrated that it was possible to incorporate primary data on end-users’ preferences into a rapid advice guideline for a public health emergency in difficult field conditions. health workers perceived a balance between transmission protection and ability to care for patients effectively while wearing ppe. these findings were used by the guideline development expert panel to formulate who recommendations on ppe for frontline providers caring for evd patients in outbreak conditions. health facility transmission is a hallmark of early ebola virus disease (evd) outbreaks and usually results in infection and death of health workers particularly before the identification of ebola virus as responsible for the clinical presentation of one or a cluster of patients [ ] [ ] [ ] . contributing factors include nonspecific clinical presentation, lack of local advanced diagnostic capabilities and suboptimal infection prevention and control (ipc) practices, amplified by poor surveillance in struggling health systems. the epidemiological pattern of the - evd outbreak in west africa revealed a similar story, but this time with an unprecedented scale and geographic spread, resulting in a record number of affected health workers, with cases and deaths by late . health workers are more likely than non-health workers to be infected: depending on the profession, the risk can be to times higher . the correct use of personal protective equipment (ppe) as part of comprehensive ipc measures contributes to the prevention of evd transmission in healthcare settings by providing a protective barrier from contaminated fluids. however, the characteristics of the material and the configuration of the equipment may lead to health worker discomfort, overheating, and concerns about dexterity and safety to perform clinical tasks when ppe is used in the typical conditions of high heat and humidity present in west african evd treatment centers , . as the united nations' international health agency, the world health organization (who) has the mandate to support member states in preparing for and responding to a wide range of public health emergencies that often require that new technical guidance is developed in short timelines with scarce evidence base. following an urgent request from affected member states, who started the production of a ppe guideline for evd outbreaks in july , shortly before declaring the evd outbreak in west africa a public health emergency of international concern. a rapid review of the efficacy and comparative effectiveness of various components of ppe was commissioned in preparation for an expert panel meeting to develop recommendations on optimal ppe for health workers in ebola treatment units (etus) in outbreak settings. it became clear very early in the process that high quality efficacy and comparative effectiveness studies addressing the use of specific ppe items for evd in outbreak settings were lacking . in addition to the paucity of data, it was critically important to gather and include the perspectives of health workers who had "real-life" experience in etus in west africa. early reports of the local conditions indicated that broader clinical questions than ppe performance as a transmission barrier were as important: usability, comfort, dexterity and impact on communication with patients, for example. the underlying principle was that evidence from efficacy and comparative effectiveness studies was necessary but insufficient for contextualization and adequate decision-making. this approach highlights the importance of understanding the way individuals exercise judgement (values and preferences) when selecting options with potential benefits, harms, and inconveniences in real life and is current best-practice in who standard guidelines . values and preferences are often informed mainly by the opinion of guideline expert panel members, however such proxies for persons affected by the recommendations in a guideline are often inadequate or even inaccurate. thus, in the early stages of the - evd outbreak in west africa, in the context of time constraints and the absence of published data, it was crucial to incorporate the values and preferences of health workers into the guideline development process. the purpose of this study was to support the development process of a who rapid advice guideline on ppe for evd care in outbreaks. the specific objectives were to understand and describe frontline physician and nurses' perspectives about ppe use, while providing direct care for evd patients in the unprecedented conditions of the - evd outbreak in west africa and to incorporate these findings into the rapid advice guideline development process. in september , we electronically surveyed international frontline physicians and nurses who participated in foreign medical teams deployed to the affected countries in early stages of the evd outbreak. the pragmatic approach was necessary given that this survey was developed and delivered at the height of outbreak and that who had very limited time available in which to produce guidance. the online, -item survey was developed specifically for this study (supplementary file ). the first section consisted of multiple-choice questions examining participant demographic characteristics, role, and experience with ppe in west africa. the next section addressed health worker exposure to the following specific components of ppe: eye protection (goggles/face shields), nose and mouth protection (medical mask/particulate respirator), gloves (single/double gloves), body covering (gowns/ coveralls), foot wear (boots/closed shoes), and head covering (hair cover/hoods). in subsequent sections, we used a four or five-point likert-scale to examine participants' perceptions about the impact of each ppe item on the following domains: safety, communication, ability to provide patient care, personal wellbeing (heat and we have made changes to the text based on the referees' comments, in particular emphasizing the connection to oxidative stress in the abstract and expanding the discussion. in response to the suggestions and comments from the reviewers we have made several edits to our research paper. first of all, we have revised table by adding categories that were previously omitted from the table. for example, in version we only presented in the table the number health workers that indicated they felt at extremely low or low risk, but in version we have added a column indicating the number of health workers feeling at high or extremely high risk. we have also added a foot note explaining how the denominator in each cell reflects missing values for that particular question. we hope that this has improved the readability of the table. second, we have added some additional references to the literature on ppe in the discussion. finally, we have added a few small clarifications and moved some text to other sections in the paper. revised dehydration), and comfort. in addition, for each of the items, participants could provide free-text comments on open-ended questions to describe any difficulties or to provide suggestions on how ppe could be improved. the final section explored specific training needs and confidence in ppe. the last question asked participants to compare two sets of ppe available in west africa shown side-by-side in a picture: one was composed of lighter items and the other had more robust components. five experts reviewed the study protocol and questionnaire during the development phase. subsequently, three clinicians with experience in the evd outbreak in west africa similar to that of the sampling frame field-tested the survey for consistency, readability, completeness, and question sequencing. the final version of the online survey incorporated all relevant feedback and comments. we obtained expedited approval of the study protocol and survey from the who ethics review committee (rpc ). we contacted potential participants via email. the first email explained the objectives, expected time commitment, and provided a link to the informed consent form and online survey on survey monkey ® . participation was voluntary and implied informed consent. a follow-up email in days reminded potential participants of the deadline ( days after launching). participants could withdraw from the study at any time without providing any justification. the study population consisted of international frontline physicians and nurses with direct field experience caring for evd patients in west africa. our sampling frame targeted international physicians and nurses deployed by who and médecins sans frontières (msf) to west africa between march and september . we used maximum variation purposeful sampling, a non-probability sampling strategy, to capture a wide range of health worker perspectives and experiences in two organizations and four different countries affected by the evd outbreak. health workers were reached through a contact individual in each organization (msf and who) who directly emailed potential participants. physicians and nurses from the affected countries and from other international organizations were not included for pragmatic reasons given the extreme time constraints and infeasibility of obtaining additional organizational approvals in the available timeline. an initial communication error led to the participation of other groups of health workers that did not have frontline clinical experience. the perspectives of these workers were considered for who quality improvement efforts, but were excluded from this analysis as these groups were not part of the approved sampling frame for this study. participants could indicate their experience with more than one item for each ppe component (e.g., both goggles and face shields for eye protection). for the purpose of statistical analysis, we considered each participant's experience with a ppe item unique and independent (i.e. we did not account for the fact that the experience came from one and the same health worker). we analysed closed-ended questions with stata (statacorp. . college station, tx) using counts, proportions, and the chi-square test when comparisons were appropriate. two independent researchers analysed the answers to the openended questions using an iterative and reflexive process. this encompassed close reading and re-reading of the answers using constant comparison within and across different participants to identify key topics. the researchers then grouped the interpretations and understanding of the participants' ideas and selected quotes to represent these findings, discussing discrepancies to achieve agreement. immediately after data collection with the survey monkey ® instrument, all information was downloaded to an anonymized spreadsheet and removed from the online database. all analyses were performed on de-identified data. informing rapid advice guideline recommendations the rapid advice guideline was developed using the grading of recommendations assessment, development and evaluation (grade) approach , . with this approach, clinical and public health recommendations are based on a systematic review and critical appraisal of the evidence on benefits and harms of an intervention, and an assessment of the balance between the two. other considerations are also taken into account when an expert panel formulates recommendations, including feasibility, acceptability and resource implications of the intervention options, and the effects on equity across subpopulations. the relative value of the potential outcomes of the intervention options and the values and preferences of persons affected by the intervention are also important considerations. the findings of the survey were presented at the guideline development meeting and incorporated into evidence-to-decision tables (supplementary file ) to inform the formulation of recommendations for ppe components in the context of an evd outbreak. evidence-to-decision tables followed the grade-decide approach and were populated by the who guideline development team in preparation for the expert panel meeting. these tables were key instruments used to present multiple sources of information to the guideline expert panel, helping to structure the discussion and to document the final judgements and decisions that underpin each recommendation. we developed the study protocol, obtained who ethics approval, contacted the participants, delivered the survey, analysed the data, and presented the findings as part of the evidence-to-decision tables at the expert panel meeting where the recommendations were formulated in a period of weeks. we invited health workers ( from msf and from who) to participate in the survey and ( %) responded. respondents from msf included logisticians and water, sanitation and hygiene experts who were excluded because they were not part of the sampling frame. thus participants ( physicians and nurses) were included in the final analysis and their characteristics are described in table . for each of the different components of ppe, one item was used by the majority of survey participants (table ) . for example, ( %) of participants had experience using goggles, while only seven ( %) had used a face shield (some participants had experience with both types of eye protection). generally, health workers felt at low or extremely low risk regardless of the type of ppe used. ppe, particularly goggles, particulate respirators, and medical masks or hoods, impaired communication (table ) . a reduction in the ability to provide care was predominantly related to eye protection equipment -both face shields and goggles. heat and dehydration were a significant or major issue for participants using goggles ( %) compared to two ( %) using a face shield (p= . ), and for ( %) using a hood compared to none using a hair cover (p= . ). heat and dehydration also were a significant or major issue for the majority of individuals using a gown (n= , %) or coverall (n= , %); however, there was no significant difference between the two groups (p= . ). goggles were considered more uncomfortable (n= , %) than face shields (n= , %, p= . ) ( table ) . participants indicated that fogging of goggles or face shields was a major issue, affecting visibility and potentially creating a hazard for health workers as well as patients. there was some indication that fogging was a bigger issue with goggles and a few participants indicated that they would have preferred a face shield. two participants indicated that the goggles caused pain after using them for extended periods. a number of participants noted that goggles did not cover sufficient skin of the face and there were requests for larger goggles, which would have the added advantage of greater visibility. other issues were the poor quality of face shield and goggles, poor fit of goggles, and the logistical challenges of waiting to clean and dry re-usable goggles. one respondent summarized it as follows: "the goggles (are) not so comfortable and (they) felt like the "unsafe" part of the ppe. they move easily, hurt on the head, and affect vision in a negative way due to sweat, etc.". medical mask and the particulate respirator were reported to cause difficulty breathing when wet (due to sweat or condensation). one participant doubted the mask's effectiveness when wet. two participants were of the opinion that respirators were excessive since evd is not airborne. the main problem regarding gloves was the risk of having them slip down, allowing fluids to contact the skin as illustrated by the following respondent: "some people found using tape over gloves (the second pair) useful as sometimes they did roll down during arduous patient care activity and in the end i also did this". other participants also attempted to solve this problem by taping gloves to the coverall, however this occasionally resulted in the tearing of gloves or the coverall. it was also mentioned that gloves were not long enough and that they tore easily. difficulties included finding the right size coverall -in several instances the available coveralls were too small, leaving the health worker to opt for a coverall of lesser quality or have difficulties removing the coverall. a number of health workers indicated that they had difficulty taking off the coverall. specific issues included having to remove the face shield first, leaving the eyes and face unprotected while undressing from the coverall, and problems taking off the coverall over large rubber boots. one respondent mentioned that coveralls with attached shoe covers could increase the risk of tripping. one respondent commented that boots were too big causing difficulty walking on irregular ground. as for reusable items (goggles and boots), it was mentioned that the time required to fully decontaminate and dry them sometimes brought challenges and put pressure on the team. training on ppe use a third of survey participants had received formal training over to days (n= , %) and four ( %) reported training duration of more than days. on the other hand, % (n= ) had received no formal or on-the-job training and another % (n= ) reported training for hours or less. the remaining % of study participants (n= ) had training of one day or less. a number of participants commented that they would have liked to have had training, more formal training, or longer training. others indicated that they would have liked to receive training before their departure, or before arriving at the treatment centre. the training topics that the survey participants would have liked included were the removal of ppe, and, how to manage eye glasses. one health worker recommended weekly refresher training, especially in the light of frequent equipment changes, which may impact the order items are put on and taken off. another health worker commented: "i believe that only experienced people can teach about ebola. teaching on the use of ppe is not about dressing and undressing. it is about using a set of behaviours with it and the understanding of all the underlying water and sanitation principles and applying them". regarding hand hygiene, alcohol-based hand-rub was not always available and there was conflicting information in different settings about which product to use. the majority of participants (n= , %) were very confident that they were using ppe correctly, ( %) were reasonably confident and ( %) was not very confident. generally, participants were least confident about goggles (fogging, moving/displacing), medical masks and particulate respirators (difficulty breathing, becoming uncomfortable), and gloves (rolling down, tearing). removing ppe was also an area that people felt less confident about (e.g., taking arms and feet out of a coverall, lack of face protection during undressing if the face shield was worn outside the hood). as one health worker illustrated: "taking off the (tyvek suit) coverall was difficult due to my height; it required me to wiggle out of it more than the average person". a respondent also mentioned feeling less confident working in the screening area where much lighter ppe was worn, while possibly also being exposed to infectious patients. when asked to indicate their preference regarding two sets of ppe depicted in a picture, ( %) participants preferred the ppe that was composed of lighter items, ( %) participants preferred the more robust components, ( %) did not have a preference and one participant did not respond to the question. the - evd outbreak in west africa required extensive local and international response and for the first time since evd was described in , a large number of organizations were directly involved in clinical and laboratory activities in the field. these interactions highlighted differences in the selection and use of ppe across the organizations. early on in the outbreak, when the cases of health worker transmission were numerous and confusion about the best available equipment was wide-spread, who was asked to provide technical guidance in a short period of time. when a public health emergency involves a new disease, or a known disease with a different presentation, there may be scarce or no evidence on the benefits and harms of potential interventions. indirect evidence (e.g., from related diseases such as other blood-borne pathogens and simulation), expert opinion, and data acquired and analysed in real-time may become the best available evidence for the guideline panel. in addition, factors other than the effectiveness of interventions may have a significant influence on the direction and strength of the recommendations. such was the situation in during the height of the evd outbreak in west africa; a rapid review of the effectiveness of different types of ppe for protecting health workers revealed insufficient evidence upon which to draw conclusions about optimal ppe . in this context and within a period of weeks, we developed and executed a survey, the results of which formed a critical part of the evidence upon which the recommendations developed by the expert panel were based . to the best of our knowledge, this approach of collecting primary data regarding the values and preferences of persons affected by clinical or public health recommendations in a guideline is novel in the extremely challenging setting of a public health emergency. overall, our findings showed that health workers perceive a balance between transmission protection and the ability to effectively care for complex patients while using ppe. health workers accept a certain degree of discomfort in return for the protection provided by ppe. the survey highlighted a slight preference of health workers for face shields compared to goggles because of less fogging, easier communication and better fit. there was no strong preference for one item of ppe over the other for all other ppe components. given the variation in preferences for different components of ppe and the absence of data on comparative effectiveness, it may be important to provide a choice for health workers. this was, in fact, a guiding principle during the development of the ppe guidelines. several issues raised by survey participants should be relatively straightforward to address, making a major contribution to health worker safety and comfort, such as providing a sufficient range of sizes, choice of equipment, and adequate training on how to put on and take off ppe in the conditions that will be faced in the field. active training, in which health workers receive face-to-face training has been shown to improve doffing procedures . we experienced a number of challenges planning and executing this study. we had to develop a survey questionnaire de novo with limited time for field testing. although this likely had a minimal impact on the results, we noted two questions that participants appeared to have difficulty comprehending (questions and ; see supplementary file ); if we had had more time for field testing we could have revised the questionnaire before formal data collection began. while our aim was to include only health workers who had provided direct patient care, such as nurses and physicians, given a communication error early in the study, we invited to participate and consequently received responses from workers without direct clinical experience who had been deployed to the evd outbreak. because these workers were not part of our pre-defined sampling frame, we excluded their responses from the analysis. similarly, our survey failed to take into account the fact that ppe consists of different components such as eye protection, nose and mouth protection, gloves and body coverings that work together to protect the health worker from the risk of infection. in the first part of our questionnaire we asked how the survey participant experienced individual components of ppe (e.g., goggles or face mask). however, it is difficult to review these components as isolated items, separate from the rest of the ppe. as one survey participant noted: "it is the combination of the respirator and the face shield which is difficult. one or the other would be manageable but both together meant major impairment". another survey participant commented: "the coverall would probably be better tolerated if we could breathe easier and see without problems". in addition, although we compared gowns and coveralls, we did not specify or ask about the materials the body coverings were made of, its level of fluid resistance, or whether the head cover was attached or not. such issues can have a significant impact on health workers' experiences. for example, a simulation study carried out in hong kong in response to the outbreak of severe acute respiratory syndrome (sars) found that ppe made of more breathable material did not lead to a significant difference in contamination but did have greater user satisfaction , . it also became clear that solutions to an issue with one component of ppe could compromise the safety of another element of ppe. for example, participants mentioned that they would improvise and tape gloves to the coverall in order to prevent them from slipping down, but then the coverall would tear when removing the tape. finally, the combination of different components of ppe may change the order in which ppe items are put on and taken off, thus end-users may perform donning and doffing procedures that are different than the training they received. this is particularly relevant if there are frequent changes in the availability of specific types of ppe, as was the case early in the outbreak response. most of the limitations of this study were caused by pragmatic decisions the research team had to make in order to complete the study in the available time. this was in and of itself an invaluable learning experience for undertaking similar projects in the future. specifically, we had to include only international health workers deployed by who and msf in our study; therefore, we did not collect information on the values and preferences of local health workers and health workers deployed by other organizations. there were two important reasons as to why we selected our sampling frame. first, we carried out the survey at the height of the evd epidemic when local doctors and nurses were fully engaged in the response efforts and we refrained from removing them from their primary work. internationally recruited health workers on the other hand, were usually deployed for shorter periods and could thus participate when they returned home. second, we had little time in which to execute the survey before the guideline meeting and we anticipated that it would be a lengthier and more complex process to identify and recruit local health workers. thus, the findings of this survey may not be applicable to local health workers. in addition, generalizability of our findings to other international health workers involved in the ebola response may be limited due to the small size of our purposive sample. in the context of the most challenging of research settings, our study proceeded very efficiently and effectively in several regards. peer reviewers for both the study protocol and draft survey made very helpful comments within to days. the who ethics review committee approved the survey in less than two weeks. by reaching out to several key managers and opinion leaders from the two organizations, we were quickly able to identify frontline clinicians that were part of the sampling frame. the online format of the survey allowed us to quickly reach a larger number of health workers in different countries who had recent personal experience with different types of ppe in the evd outbreak. the combination of different types of questions in our survey also worked well. closed and likert-scale questions made analysis of trade-offs and comparisons of health workers' preferences possible while open-ended questions allowed the survey participants to share additional thoughts and perspectives in more depth. our study highlights some of the challenges and potential limitations and demonstrates the feasibility of generating and incorporating primary data on end-users' values and preferences into a rapid advice guideline developed during the height of a public health emergency with extreme field conditions. our survey showed that health workers perceive a balance between transmission protection and their ability to effectively care for patients while wearing ppe. these findings were a critical part of the information used by the guideline development expert panel when formulating recommendations on ppe for frontline health workers caring for evd patients in outbreak conditions. we obtained expedited approval of the study protocol and survey from the world health organization ethics review committee (rpc ). as approved by the ethics committee, we provided a link to the informed consent form with the survey. participation was voluntary and implied informed consent. supplementary file : study questionnaire. click here to access the data. supplementary file : evidence-to-decision tables used in the formulation of recommendations for the who rapid advice guideline: personal protective equipment in the context of filovirus disease outbreak response. click here to access the data. author response mar , world health organization, switzerland saskia den boon i had difficulty reading the tables in the article. i thought maybe it was the way they were displaying on my computer, but nothing seemed to change when i clicked on them. please make these charts simple to read and clear. i need to see the tables to make sure your findings are adequately described. thank you for reviewing and approving our paper. we assume that you are author's response: referring to table . we have revised the table by adding the categories that were previously omitted from the table. for example, in version we only presented in the table the number health workers that indicated they felt at extremely low or low risk, but in version we have added a column indicating the number of health workers feeling at high or extremely high risk. we have also added a foot note explaining how the denominator in each cell reflects missing values for that particular question. we hope that this has improved the readability of the tables. the article is really well written. i was very pleased with the quality of the writing and the honesty of the authors about their challenges. this is important work in the area of ppe use. thanks for these kind words about our study. author's response: while i know that this was quick work in a difficulty setting, i still feel like the article needs to do justice to personal protective equipment research of the past years (at least since sars). the major section that needs more referencing is the discussion section. how do your findings compare to what we have found in epidemiological studies, simulation studies, and others on ppe. even if these studies were not done in the context of an outbreak of evd in africa, they should still be discussed. there is literature on some of these areas that would bring worthwhile context to your findings. thanks for this suggestion. we have added a number of references to the author's response: literature to our discussion section. well written paper on an important and largely ignored subject: 'health workers perspectives for guidelines'; also on top global health issue 'ebola virus disease'. study process was speedy and appropriate for the urgency needed for guidelines to be developed making this a good learning experience. however, there are a few points of attention listed below. i have also highlighted the sections relevant to my comments . here 'the - evd outbreak in west africa was initially declared a public health emergency of international concern in early august , coinciding with the decision to develop a who rapid advice guideline on the selection and use of ppe for evd care in outbreaks.' this statement will fit more within the background section, consider moving into background. 'we electronically surveyed international frontline physicians and nurses who participated in foreign medical teams deployed to the affected countries in early stages of the evd outbreak.' clearly stating time frame in the methods section within which survey was done will also be helpful for readers, although a time frame is given later under participants, it is not clear if this was for survey or the sampling. this time frame is also very early in the outbreak aq : settings is not well described, consider discussing setting in more detail under a separate title. clinicians express discomfort and safety, it may be interesting to know if at some point in the interviews they weighed in on safety versus comfort e.g. will the feeling of safety make them cope with discomfort? or does discomfort make safety inconsequential? i have answered 'partly' to the question "is the work clearly and accurately presented and does it cite the current literature?" as a small part of the methods may benefit clarity if texts are moved around. i have answered 'partly' to the question "are the conclusions drawn adequately supported by the results?" as it will be important to discuss discomfort versus safety of risk or clearly state if this was not evaluated by the study. this is an interesting piece and important in the context of infectious diseases. i will like to appreciate the authors for taking the initiative during such an emergency to collect such data. i will recommend the paper to be considered for indexing especially as it contributes towards developing guidelines for ppe which was more of a challenge to health workers during the outbreak. understanding their challenges and experiences especially in very humid temperatures is important. most importantly, the outbreak was a remarkable and most catastrophic outbreak. thus, using the outbreak as a point of focus adds value to the work considering that it pulled health workers from various countries. the work considering that it pulled health workers from various countries. why only physicians and nurses perspectives regarding ppe? i understand the relative risk for physicians and nurses as frontline workers is high, but other health workers are involved, and have recorded fatality rates, their experiences with ppe may also add value especially in the context of developing guidelines. maybe the authors should consider adding this to limitations. four or five likert is not explicit; it does not tell which questions were measured using scales of four and which used five and how they way categorize for-example., indicating low or high? agree or somewhat agree? understand the sample size was small and is actually mentioned as a limitation, however, any data on number of nurses and physicians that were deployed by who and msf during the period of data collection for background purposes and to justify the limitation? the sentence under data analysis is not clear to me, maybe rephrasing to better explain to the audience "for the purpose of statistical analysis, we considered each participant's experience with a ppe item unique and independent." the survey assumes that all the participants speak and write english? language characteristic not mentioned considering that these affected countries some are french countries. if all participants were not english speaking how was it translated? especially as the authors mentioned that respondents could not comprehend some questions due to time constraint. the literature highlights some gender differences for ppe amongst physicians and nurses especially in african context-assuming nurses are mostly women and physicians men--it would have been good to explore differences between nurses and physicians with regards to the specific ppe used. were physicians exposed to more sophisticated ppe than nurses? other comments that may be of interest to the authors: i understand the limitation of the paper is focused on participants in ebola treatment centers and only foreign deployed. however, guidelines should take into consideration local reality in terms of culture? based on previous outbreaks, most families prefer to care for patient at home and given the limited resources in this context; local materials were used at home in as ppe . http://www.cnn.com/ / / /health/ebola-fatu-family/index.html given the reality of limited resources, and the fact that most families prefer to care for patient at home it would add more value also to consider experiences of those who cared for patient at home, the type of ppe used and opportunities in incorporating local reality into evidence-based guidelines for ppe. if applicable, is the statistical analysis and its interpretation appropriate? yes settings is not well described, consider discussing setting in more detail under a separate title. we are not sure how to respond to this question of the reviewer. we did an author's response: online survey among health workers who were deployed by msf or who to respond to the ebola outbreak in west africa early on in the epidemic. health workers worked in local hospitals, clinics or ebola treatment centers, but because we did not ask further information about these settings we cannot provide a more detailed description. clinicians express discomfort and safety, it may be interesting to know if at some point in the interviews they weighed in on safety versus comfort e.g. will the feeling of safety make them cope with discomfort? or does discomfort make safety inconsequential? we assume that the reviewer is referring to question which asked, "please author's response: indicate how safe you felt by ticking a box for each aspect of personal protective equipment". as we have stated in the discussion, survey participants had difficulty answering this question because of the way the answer categories were phrased, e.g. "extremely low risk, i felt comfortable". in this answer category we wanted comfortable to mean "i am not worried about safety", but this was sometimes interpreted as "i am physically comfortable (e.g. not overheated, etc.)". if we had had more time for piloting, we would have been able to pick this up before sending out the survey. however, through comments from health workers it became clear that they indeed cope with discomfort because the ppe makes them feel safe and we have added the following sentence to the discussion: "health workers accept a certain degree of discomfort in return for the protection provided by ppe". i have answered 'partly' to the question "is the work clearly and accurately presented and does it cite the current literature?" as a small part of the methods may benefit clarity if texts are moved around. we hope that our amendments have improved the methods section. author's response: i have answered 'partly' to the question "are the conclusions drawn adequately supported by the results?" as it will be important to discuss discomfort versus safety of risk or clearly state if this was not evaluated by the study. we hope that our amendment has taken away the concern of the reviewer. author's response: this is an interesting piece and important in the context of infectious diseases. i will like to appreciate the authors for taking the initiative during such an emergency to collect such data. i will recommend the paper to be considered for indexing especially as it contributes towards developing guidelines for ppe which was more of a challenge to health workers during the outbreak. understanding their challenges and experiences especially in very humid temperatures is important. most importantly, the outbreak was a remarkable and most catastrophic outbreak. thus, using the outbreak as a point of focus adds value to the work considering that it pulled health workers from various countries. thank you for reviewing our paper and for making helpful comments and author's response: thank you for reviewing our paper and for making helpful comments and author's response: suggestions. see below our responses. why only physicians and nurses perspectives regarding ppe? i understand the relative risk for physicians and nurses as frontline workers is high, but other health workers are involved, and have recorded fatality rates, their experiences with ppe may also add value especially in the context of developing guidelines. maybe the authors should consider adding this to limitations. we agree with the reviewer about the importance of ppe for other health author's response: workers, for example cleaners, laboratory workers, burial teams and other workers. however, the focus of the who guideline which our study aimed to inform, was on healthcare workers and therefore we also focused our survey on this group. four or five likert is not explicit; it does not tell which questions were measured using scales of four and which used five and how they way categorize for-example., indicating low or high? agree or somewhat agree? we agree with the reviewer that it would have been better to have used a author's response: comparable (e.g. -point scale) for all the questions. if we had more time for piloting, we may have picked this up before sending out the survey. now, the questions on safety and comfort had a -point scale and questions on communication, ability to provide care, and heat and dehydration had a -point scale. as can be seen in the questionnaire which is included in the supplementary material, we did not use coding in the answer categories. understand the sample size was small and is actually mentioned as a limitation, however, any data on number of nurses and physicians that were deployed by who and msf during the period of data collection for background purposes and to justify the limitation? as stated in the results section, we invited health workers ( from msf author's response: and from who) to participate in the survey, but this included health workers outside the sampling frame (e.g. logisticians and water, sanitation and hygiene experts). unfortunately we do not have more detailed information on numbers deployed. the sentence under data analysis is not clear to me, maybe rephrasing to better explain to the audience "for the purpose of statistical analysis, we considered each participant's experience with a ppe item unique and independent." we have now added the following clarification to the methods section: "i.e. we author's response: did not account for the fact that the experience came from one and the same health worker". the survey assumes that all the participants speak and write english? language characteristic not mentioned considering that these affected countries some are french countries. if all participants were not english speaking how was it translated? especially as the authors mentioned that respondents could not comprehend some questions due to time constraint. yes, this is correct. we assumed that all participants could speak and write author's response: english and we did not translate the questionnaire. the miscomprehension was due to the fact that two questions were not phrased clearly, rather than the language skills of the survey participants. the literature highlights some gender differences for ppe amongst physicians and nurses especially in african context-assuming nurses are mostly women and physicians men--it would have been good to explore differences between nurses and physicians with regards to the specific ppe used. were physicians exposed to more sophisticated ppe than nurses? ppe used. were physicians exposed to more sophisticated ppe than nurses? this is a very interesting question. although our study was not designed to author's response: answer this question and the number of participants was too small to do any stratified analysis, i had a brief look at the data. we indeed found a higher proportion of physicians among males ( %) than among females ( %), but there were no obvious differences in robustness of ppe, when i compared gown or coverall use between males and females, or between physicians and nurses (varying between - % using a gown). other comments that may be of interest to the authors: i understand the limitation of the paper is focused on participants in ebola treatment centers and only foreign deployed. however, guidelines should take into consideration local reality in terms of culture? based on previous outbreaks, most families prefer to care for patient at home and given the limited resources in this context; local materials were used at home in as ppe . http://www.cnn.com/ / / /health/ebola-fatu-family/index.html given the reality of limited resources, and the fact that most families prefer to care for patient at home it would add more value also to consider experiences of those who cared for patient at home, the type of ppe used and opportunities in incorporating local reality into evidence-based guidelines for ppe. we acknowledge the importance of this issue brought up by the reviewer but it author's response: fell outside the scope of the study and the who guideline that we were aiming to inform. the benefits of publishing with f research: your article is published within days, with no editorial bias you can publish traditional articles, null/negative results, case reports, data notes and more the peer review process is transparent and collaborative your article is indexed in pubmed after passing peer review dedicated customer support at every stage for pre-submission enquiries, contact research@f .com report of a who/international study team we thank the following people for providing invaluable comments on the project proposal and questionnaire: patricia hudelson, gordon guyatt, martine verwey, doris bacalzo and elie akl. we are grateful to armand sprecher from médecins sans frontières for sending the questionnaire to his staff during the peak of the outbreak response. we are also grateful to the survey participants for making this study possible. participants could withdraw from the study at any time without providing any justification. due to the small number of survey participants, the detailed information collected, and the terms in the consent form approved by the who ethics review committee, which guaranteed participant anonymity, the individual-level data cannot be made available. requests for raw data can be dealt with on a case-by-case basis by contacting the corresponding author dr den boon, who will facilitate enquiries to the who ethics review committee.competing interests sdb and cv declare no competing interests. mf declares that his spouse is an employee at bristol myers squibb and owns company stock as part of her remuneration plan. sln declares that she is a member of the grading of recommendations assessment, development and evaluation (grade) working group, has published numerous papers related to grade, and that her career has benefited from this relationship. grade is the guideline process used by her employer, the world health organization, to develop guidelines. this study was funded by who core funds. no external funding was obtained.the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. i had difficulty reading the tables in the article. i thought maybe it was the way they were displaying on my computer, but nothing seemed to change when i clicked on them. please make these charts simple to read and clear. i need to see the tables to make sure your findings are adequately described. the article is really well written. i was very pleased with the quality of the writing and the honesty of the authors about their challenges. this is important work in the area of ppe use.while i know that this was quick work in a difficulty setting, i still feel like the article needs to do justice to personal protective equipment research of the past years (at least since sars). the major section that needs more referencing is the discussion section. how do your findings compare to what we have found in epidemiological studies, simulation studies, and others on ppe. even if these studies were not done in the context of an outbreak of evd in africa, they should still be discussed. there is literature on some of these areas that would bring worthwhile context to your findings. are all the source data underlying the results available to ensure full reproducibility? yes no competing interests were disclosed. are all the source data underlying the results available to ensure full reproducibility? yes no competing interests were disclosed. competing interests: we have read this submission. we believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. well written paper on an important and largely ignored subject: 'health workers perspectives for guidelines'; also on top global health issue 'ebola virus disease'. study process was speedy and appropriate for the urgency needed for guidelines to be developed making this a good learning experience. however, there are a few points of attention listed below. i have also highlighted the sections relevant to my comments . here thank you for reviewing and approving our paper. see below our responses to author's response: your comments. we have made a number of changes in the text in response to your comments. 'the - evd outbreak in west africa was initially declared a public health emergency of international concern in early august , coinciding with the decision to develop a who rapid advice guideline on the selection and use of ppe for evd care in outbreaks.' this statement will fit more within the background section, consider moving into background.we removed this sentence from the methods section and have added it, author's response: slightly modified, to the background section. 'we electronically surveyed international frontline physicians and nurses who participated in foreign medical teams deployed to the affected countries in early stages of the evd outbreak.' clearly stating time frame in the methods section within which survey was done will also be helpful for readers, although a time frame is given later under participants, it is not clear if this was for survey or the sampling. this time frame is also very early in the outbreak we send out the request for participation in september and have added author's response: this to the methods section. later we indicate that the survey was open for a -day period. the health workers eligible for participation were those who were deployed to west africa between march and september which was already stated in the methods section under participants. settings is not well described, consider discussing setting in more detail under a separate title. key: cord- -yqcc iv authors: reitmanova, sylvia title: “disease-breeders” among us: deconstructing race and ethnicity as risk factors of immigrant ill health date: - - journal: j med humanit doi: . /s - - - sha: doc_id: cord_uid: yqcc iv race and ethnicity are well-established epidemiological categories that relate to the patients’ risk of exposure and their susceptibility/resistance to disease. however, this association creates the notion that factors other than a personal identity need not be held responsible for patients’ health problems. this work deconstructs the notion of race and ethnicity as risk factors for immigrant ill health, which is prevalent in current medical research and practice, by tracing its roots in canadian history. the understanding that medical knowledge is subject to diverse historical, social, cultural and political influences can change the way health professionals perceive their patients as a health threat. therefore, in this work i would like to deconstruct the notion of race and ethnicity as risk factors for ill health and, as well, elaborate on the relevance of these epidemiological categories to medicine and society. by the end of this article, readers should be able to understand to what degree someone's race and ethnicity can be associated with his or her ill health. they should also be able to trace the roots of the thought processes that led the physician examining my daughter to suspect a foreign origin of her condition prior to considering other options. race and ethnicity in epidemiology: a double-edged sword race and ethnicity are, indeed, long and well-established epidemiological categories defining patients' characteristics in company with other important categories such as age, sex, socio-economic status, marital status, lifestyle, etc. these factors are important in two regards: they relate to the patient's risk of exposure and his/her susceptibility/resistance to disease. the role of epidemiologists is therefore to search for the existing associations between these particular categories and specific diseases in order to determine the risk factors. some results of this epidemiological quest are well-known. for instance, old age is associated with a higher risk of cardiovascular disease, a sex worker's occupation with a higher risk of sexually transmitted disease, and a smoker's lifestyle with cancer. the purpose of epidemiological categories such as a patient's ethnicity and race can be understood in a similar way. for example, while canadian aboriginals are found to be at a higher risk of drug abuse-related health problems, immigrants are associated with a higher risk of developing tuberculosis than their non-aboriginal counterparts. although social scientists argue that race and ethnicity are social and not biological constructions , , and therefore irrelevant as epidemiological variables, the establishment of associations between one's race or ethnicity and specific health problems represents a useful medical concept. for example, if aboriginal people are found to be at a higher risk of contracting hiv than other groups in canada, then public health efforts can be directed towards aboriginal communities. linking one's race or ethnicity and a specific health problem can attract more resources with which to address a broader range of health-relevant problems in that particular community. furthermore, without recognizing race or ethnicity, scientists, researchers, decision makers and service providers cannot truly identify those who are the most disadvantaged and the most deserving of their help. however, despite the advantages of this approach, establishing an association between race or ethnicity and a specific health problem represents a double-edged sword because the association itself creates the notion that factors other than a person's racial or ethnic identity need not be held responsible for his or her health problems. as a result, it is often someone's personal agency that is blamed for his/her final health outcomes rather than the social environment in which these health outcomes are embedded. , the single association between a patient's race or ethnicity and health may not reveal other important factors shaping his or her risk of exposure or susceptibility to disease. for instance, it is well established that tuberculosis is a social disease affecting largely those at the bottom of the social ladder. in fact, some authors consider tuberculosis as a penalty for "ruthless exploitation" of the poor in capitalist economies. , for this reason, establishing that being an aboriginal or a third world person is per se a risk factor for developing tuberculosis ignores large socio-economic and political forces which frame the life chances and health of these people. linking personal health with one's race or ethnicity is a very old concept in western societies. in fact, the understanding of the health of immigrants has always been dominated by the sick-immigrant paradigm which assumed that it is sickness that leads people of diverse races and ethnicities to leave their homelands and seek a new life in another country. adhering to this ideological framework, immigrants were often suspected as reservoirs or vectors of many diseases and for that reason were assumed to pose a health threat to residents of their recipient countries. as hall writes: statistics in the united states show that the foreign-born 'furnished two and one-third times their normal proportion of [the] insane. they have been the cause of epidemics and of the spread of much infection…favus and trachoma were practically unknown in the united states before the immigration from southern and eastern europe…. probably the worst effect of immigration upon the public health is not the introduction or spread of acute diseases, but of large numbers of persons with poor physique who tend to lower the general vigor of the community. ' similar assumptions about immigrant ill health formed the basis for compulsory medical assessment of all immigrants entering canada. the purpose of this assessment was to select only the fit and the desirable. as a result, the canadian immigration regulations debarred from canada, among others, the following immigrants: . idiots, imbeciles, feeble-minded persons, epileptics, insane persons, and persons who have been insane at any time previously. . persons afflicted with tuberculosis or any contagious or infectious disease. . persons who are dumb, blind, or otherwise physically defective, unless security is given against such persons becoming a public charge in canada. . persons over years of age who are unable to read. . persons who are guilty of any crime involving moral turpitude; persons seeking entry to canada for any immoral purpose. . beggars, vagrants, and persons liable to become a public charge. . persons suffering from chronic alcoholism or the drug habit, and persons of physical inferiority whose defect is likely to prevent them making their way in canada. government reports documented the following health causes for deportation of immigrants from canada: tuberculosis, rheumatism, insanity, failing eyesight, physical and mental weakness, epilepsy, heart disease, varicose veins, leg ulcer, empyema, deafness, dumbness, twisted neck and head, old age, lost eye and thumb, pregnancy, immorality, vicious tendencies, alcoholism, chronic dysentery, diabetes, bright's disease, skin ulcer and abscess, malformations, frost bites, lead poison, and bad character. unfortunately, these records did not show how such assessments were made and to what degree they were objective and justified, taking into account that "immigrants [were] examined in groups often of , and over, and as many as , have arrived in a single day." besides being barred from entering the country, fear of immigrants also led to "campaigns against immigrant-run street markets and fruit stalls, which were condemned as germ-ridden threats to the public health. the fear of uncleanly foreigners has also been extended to imported foodstuffs." in canada, for instance, the august edition of the calgary herald appealed to canadians to boycott chinese laundry businesses as they were considered "nests of disease." for such reasons, immigrants were often subjected to surveillance, detention, or isolation. the notion of immigrants posing serious health problems and threats, however, varied significantly across race and class lines. reading woodsworth's description of characteristics and traits of various immigrant racial and ethnic groups, one can easily realize that the more closely immigrants resembled the white british living in canada and the closer their country of origin was in geographic proximity to britain, the more positive characteristics they were attributed. on the contrary, those with "brown skins," "bad characters" and "peculiar customs," such as levantines and orientals (defined at that time as chinese, japanese and hindus) appeared to be those whom canada least desired to embrace. these groups of immigrants, often seen as health and economic threats to canadians, were attributed the most negative features among all immigrants. as woodsworth noted: "whether it is in the best interests of canada to allow them to enter in large numbers is a most important question, not only for the people of british columbia, but for all canadians." similar sentiments appeared in a editorial in the vancouver sun: the attitude of the people on the coast, undoubtedly, is that we do not want east indians at all, but if we are to have them, or at least some of them, it shall be the men only, because we do not want a permanent colony of them, and one which would increase as a natural result of families being located here. this inconsistency in canadian selective attitudes and behaviours toward immigrants (on one hand, the white settlers from western europe were welcomed to this country and, on the other hand, asian immigrants were coerced to comply with various restrictions and taxes) can be explained only on the premises of racial discrimination. unfortunately, these sentiments were not exclusive to canada. for instance, the californian vallejo daily independent of published the following news piece under the title, "still they come": thirteen hundred and nine more chinamen arrived in san francisco yesterday to spread pestilence [bubonic plague] and take the bread from the mouths of our poor people. seriously, what is to be done with these creatures? the immigration is assuming frightful proportions with the prospect that, a few years hence, they [the chinamen] will swarm upon our coast like the locusts of egypt. another american newspaper, the modoc independent of , reported in a similar spirit that [t]here was no division in judgment in california as to the evil effects of chinese immigration…. it was the slave class that was shipped to this country-the lowest class of china's teeming millions. virtue was unknown to them. in a word, their habits, manners, customs, language, morality and religion constituted a system incompatible with civilization in this country. the two could not exist together, and it had been truly said that "we must conquer, be conquered or exclude them." this kind of negative reporting in newspapers coincided not only with certain attitudes toward "unscrupulous, lying, and treacherous chinamen," but also with serious actions taken against them. for instance, about , chinese immigrants were placed in quarantine, and all chinatown was burned down after only two cases of bubonic plague were discovered in hawaii in . fear of this plague led also to implementing quarantine laws in san francisco which did not apply to the houses of non-asians. incidents of violence against chinese immigrants were present in canada, as well. in , an alcohol-fuelled mob rioted in calgary's chinese district after an outbreak of smallpox was linked to a laundry business run by chinese people, although only four deaths from smallpox were reported. the calgary herald condemned the riot, but it also advised canadians to avoid sending their laundry to the chinese businesses so that they "may render the stay of chinamen in calgary useless and, in a short time, without violence, without any interference with personal liberty, … rid of what the majority regard as an obnoxious element." despite the fact that contemporary western societies, proud of their democracy, law and human rights charters, proclaim their concerns about world peace, justice and equality, many studies document that north americans believe that immigrants have been and continue to be a health threat. the passage of time between the last century and this one has not changed the notion of immigrants as "disease-breeders." in fact, tomes drew a parallel between the atmosphere of germ panic in north america that surrounded the immigration from southern and eastern europe at the beginning of the twentieth century and the one that surrounded the immigration from the third world at the end of the millennium: the association of immigration and infectious disease has intensified scrutiny of national border crossings, from ellis island inspection lines to detainment camps for haitian immigrants. as historians have noted, fears of racial impurities and suspicions of immigrant hygiene practices are common elements in both periods. recent research provides sound evidence that negative health discourses about immigrants are readily present in the western world even today, , , , whether they concern the ebola virus of black africans, the sars of the chinese, or the overreproduction of latinas, which all threaten in different ways the highly regarded and healthy bodies of white canadians, britons, or americans respectively. in addition, studies showed that more attention is paid to these assumed health risks rather than to the actual health issues of immigrants suffering from trauma, torture, malnutrition and physical violence endured in the past. moreover, immigrants' negative health images are as frequent as the images of immigrants posing threats to the safety, economic stability and cultural traditions of the native-born populations. , this negative representation of the "other" (a social construct implying immigrants' presumed or real physical, psychological and behavioural differences) can be traced to the enlightenment period, during which europe embraced the concepts of biological determinism and social darwinism. scientists of that era believed that people's minds, qualities and abilities (which were presumed to be as different as were their languages) were biologically determined. all these assumed differences had to be classified in some way. as a result of these classification efforts, carl linne first classified human races into four categories based on their physical differences. he also linked these different physical characteristics to different cultural, behavioural and moral traits. other scientists modified and advanced his classification; however, they always maintained the same organizing principle-namely, the hierarchy of races. it was the scientific and technological advancement and industrial prosperity of europe during that historic era which led scientists to a belief (which they empirically evidenced, for instance, by measuring people's skulls) that the white race was naturally and inherently superior to all other races. by maintaining this discourse of "the inferior other" in both scientific and public realms over several centuries, a non-white personal identity acquired a wide range of negative associations, connotations and meanings. said in his influential work on orientalism explained that "degenerated" and "uncivilized" non-white races were framed identically to the other undesirable elements in western societies such as criminals, the mentally ill, the poor, women, etc…. one may wonder why it is important that health professionals talk about this "othering" discourse today. as said noted, the construction of personal identity permeated by "othering" discourse is highly relevant to many political issues such as immigration, criminal law, foreign policies, and education, since those today deemed different and inferior experience profound inequalities in economic status, housing, health, education, criminal justice, and the labour market. the concept of "othering" serves as the boundarymaintaining mechanism that leads to the preservation of social distance and hierarchy between various groups in society. one of the efficient means of maintaining a socially stratified society with the white race on top of the social hierarchy is to feed continuous fear of and prejudice towards the "others." one way to feed this fear is to represent the "other" as a threat to health. for instance, by constructing immigrant personal identity as a tuberculosis threat, tuberculosis management and policies tend to focus on restricting immigration and surveying immigrants rather than on addressing the broad social, economic and political reasons which foster tuberculosis within the immigrant population. to avoid designing health policies and clinical practices operating on the premises of the "othering" discourse, we need to implement several changes in our medical, nursing or science school curricula. these curricula need to challenge the notion that disease is purely a biological entity residing in a depersonalized human body. future health professionals and service providers need to know that medical knowledge is subject to diverse historical, social, cultural and political influences. they need to reflect on how history, economy and politics-as well as their own personal biases and prejudices-can affect many health conditions, clinical practices, health policies and research, and even the structure of health organizations. , until our medical schools are ready to introduce such an educational approach, the query, "have you been abroad recently?" is likely to continue topping the list of diagnostic questions posed when addressing the health problems of our visibly different immigrant patients. mausner and others risk factors for elevated hiv incidence among aboriginal injection drug users in vancouver public health agency of canada, canadian tuberculosis standards. (public health agency of canada rethinking the color line the anatomy of racism: canadian dimensions infections and inequalities the white plague: tuberculosis, man, and society black labor: tuberculosis and the political economy of health and disease in south africa the health of immigrants and refugees in canada strangers within our gates canada-the new homeland (colonization and immigration; government of canada strangers within our gates the making of a germ panic, then and now in our opinion: more than years of canadian newspaper editorials power, medical knowledge, and the rhetorical invention of "typhoid mary strangers within our gates ibid our opinion: more than years of canadian newspaper editorials the anatomy of racism: canadian dimensions still they come congressmen berry and page on the chinese question the chinese as medical scapegoats in san francisco in our opinion: more than years of canadian newspaper editorials the making of a germ panic, then and now opinion discourse and canadian newspapers: the case of the chinese "boat people constructing a discursive crisis: risk, problematization and illegal chinese in canada when ebola came to canada: race and the making of the respectable body sars and new york's chinatown: the politics of risk and blame during an epidemic of fear when ebola came to canada: race and the making of the respectable body representations of sars in the british newspapers a glass half empty: latina reproduction and public discourse guest media lens alert: asylum and immigration. comparing the daily telegraph, the guardian and the independent opinion discourse and canadian newspapers: the case of the chinese "boat people constructing a discursive crisis: risk, problematization and illegal chinese in canada the anatomy of racism: canadian dimensions rethinking the color line: readings in race and ethnicity the anatomy of racism: canadian dimensions saving the empire: the politics of immigrant tuberculosis in canada eradicating essentialism from cultural competency education the health of immigrants and refugees in canada a glass half empty: latina reproduction and public discourse illness and medicine in canada risk factors for elevated hiv incidence among aboriginal injection drug users in vancouver the white plague: tuberculosis, man, and society. london: v. gollancz, . eichelberger, laura eradicating essentialism from cultural competency education government of canada. eastern canada. canada -the new homeland. colonization and immigration: government of canada opinion discourse and canadian newspapers: the case of the chinese "boat people power, medical knowledge, and the rhetorical invention of "typhoid mary constructing a discursive crisis: risk, problematization and illegal chinese in canada the anatomy of racism: canadian dimension. montreal: harvest house when ebola came to canada: race and the making of the respectable body congressmen berry and page on the chinese question black labor: tuberculosis and the political economy of health and disease in south africa public health agency of canada. canadian tuberculosis standards. public health agency of canada guest media lens alert: asylum and immigration. comparing the daily telegraph, the guardian and the independent saving the empire: the politics of immigrant tuberculosis in canada sellar, don. in our opinion: more than years of canadian newspaper editorials the making of a germ panic, then and now the chinese as medical scapegoats in san francisco, - representations of sars in the british newspapers strangers within our gates key: cord- -op qshp authors: dar, osman; hogarth, sue; mcintyre, sabrina title: tempering the risk: rift valley fever and bioterrorism date: - - journal: trop med int health doi: . /tmi. sha: doc_id: cord_uid: op qshp nan keywords rift valley fever, bioterrorism, research, biosecurity, global health rift valley fever virus (rvfv) is an arthropod-borne pathogen that primarily affects ruminants in eastern and sub-saharan africa first described following an outbreak on a farm in kenya in . periodic outbreaks of rvfv since that time have resulted in significant losses to the african livestock industry as well as large numbers of infections in some of the most impoverished human populations. in one / outbreak across kenya, somalia and tanzania alone, there were an estimated human cases, and the ban imposed on imports after the / outbreak in somalia led to a collapse of the vital livestock industry. previously ignored, it is only in the past decade that the international community has started to take an increased interest in the disease. this followed the recognition of its potential to spread beyond the confines of the african continent after a large outbreak in saudi arabia in . there has also been acknowledgement of the widespread presence of arthropod vectors capable of transmitting rvfv in many nonendemic regions of the world. this has led to a range of increased efforts in better understanding the virus and developing tools to predict outbreaks, combat the disease and limit its spread (anyamba et al. ; pepin et al. ) . however, a more longstanding, parallel interest in the disease has also developed internationally; one centred around the biosecurity implications of the virus. the united states for instance, included rvfv as a candidate pathogen in its offensive biological weapons programme; a programme officially closed in (borio et al. ) . in more recent times, the classification of the virus as a potential bioterrorism agent has spurred investment and activity, particularly in the area of vaccine development and diagnostics (borio et al. ; sidwell & smee ) . while biosecurity interest has contributed to this increased funding over the past few decades, most notably from military sources such as the us army medical research institute of infectious diseases (usamriid), it may have acted as an impediment to international collaboration, with research being restricted to fewer, more expen-sive laboratories. after the signing of the us patriot act of and the classification of rvfv as a 'select agent', visiting experts and scientific collaborators are, for instance, now required to provide fingerprints, signed affidavits and be registered with intelligence services before working with the pathogen. such measures are likely to act as a disincentive amongst scientists wanting to study the virus and could ultimately serve to drive experts to dedicate their efforts to other pathogens with fewer working restrictions (animal & plant health inspection service, centre for disease control & prevention , . these restrictions have also been applied in parts of europe as well, with national legislation such as the anti-terrorism, crime and security act of the uk, which also includes rvfv as a potential bioterrorism agent. for comparison and contrast, we include the current lists of biological agents and toxins around which bioterrorism legislation has been passed in the us and uk in table . focus on us policy internationally stems from its greater leadership role within the global community and the influence and impact its decisions have on people and institutions far beyond its borders. with large numbers of laboratories worldwide affected by us policy either directly through funding or indirectly as a result of political influence, restrictions have also resulted in the transfer between laboratories of rvfv samples for culture also becoming constrained and increasingly expensive. this undermines efforts to lower the industrial production costs of existing vaccines and of commercial kits for virus neutralisation and elisa diagnostic tests (currently the prescribed tests for international livestock trade) (world organization for animal health ). expertise and experience thus tends to remain confined to a limited number of laboratories and companies by and large located in high income countries where investigation of the disease is neither a significant economic or health priority nor considered sufficiently profitable for drug companies. the resulting monopolies on expert technical knowledge and skills not only delays progress in developing new therapies the potential risks of rvfv to animal health are indeed significant and so the deliberate release of the agent would have indirect health effects on human populations through the destruction of the livestock industry in particular. although the possibility of industrial sabotage or 'agroterrorism' is thus real, the potential direct bioterrorism risk to human health of rvfv is far more limited. on the most important criteria of pathogenicity and transmissibility, rvfv is a poor candidate choice as an anti-human bioterrorism agent, with no recorded cases of human-to-human transmission and a relatively low mortality rate of - % in humans. complicated infections, characterised by haemorrhagic fever or encephalitis, are similarly limited to about % of infected cases (pepin et al. ) . box : an excerpt from the proceedings of the 'responding to the consequences of chemical and biological terrorism.' joint seminar held between the us department of health and human services, us public health service (phs) and the office of emergency preparedness (oep) in july . "if i wanted to disrupt the mideast peace process between israel and the plo, i would infect one small, young lamb with rift valley fever virus. i would hold that lamb in a confined area for about hours; at that point in time the lamb is very sick. i bleed milliliters from his heart; i keep that blood from clotting by means of heparin. if the heparin is not available to me, i have picked up some small stones, and i have sterilized them in boiling water. i add those stones to the fluid, and i shake it up, and i prevent clotting. then i harvest the lung and the liver and get milliliters of blood and organs. i add , milliliters of a -percent skim milk solution, homogenize again in a waring blender, filter, filter, filter. i filter it through several layers of gauze, and i get , milliliters containing , , , , units of virus. using my old pal calder's mathematical model, if i disseminate that as a line source, perpendicular to the wind, milliliters per meter, and i walk along for , meters, i will infect percent of the population . of a kilometer downwind; percent of the population at . kilometers downwind; and percent of the population kilometers downwind. i have hedged here. i have used very good meteorological conditions. the ridge height, or course i am walking along spraying, is zero feet. the transport wind is miles per hour, which is very good for transport of a bw agent. your diffusion parameter is n = . , the beta factor is . , and i have selected deliberately to bias the thing in my favor, a stability condition of a very strong inversion (us department of health & human services usphs, office of emergency preparedness )." while aerosolised droplet transmission of the virus is clearly possible, with notable recorded transmissions occurring in abattoir and laboratory workers from infected animal specimens and parts, this is not a unique feature amongst a plethora of infectious diseases. rvfv with its low mortality and relatively low human-to-box : us cdc and niaid categorisation of bioterrorism agents and biodefense priority pathogens. category a pathogens are those organisms/biological agents that pose the highest risk to national security and public health because they • can be easily disseminated or transmitted from person to person; • result in high mortality rates and have the potential for major public health impact; • might cause public panic and social disruption; and • require special action for public health preparedness. category b pathogens are the second highest priority organisms/biological agents. they: • are moderately easy to disseminate; • result in moderate morbidity rates and low mortality rates; and • require specific enhancements for diagnostic capacity and enhanced disease surveillance. category c pathogens are the third highest priority and include emerging pathogens that could be engineered for mass dissemination in the future because of: • availability; • ease of production and dissemination; and • potential for high morbidity and mortality rates and major health impact. human transmissibility in comparison with other viral haemorrhagic fever (vhf) viruses such as ebola, marburg or lassa, should have its risk profile assessed independently. as such, while the us centre for disease control (cdc) has indeed categorised vhf viruses as category a bioterrorism agents (box ); it specifically refers to filoviruses (e.g. ebola and marburg) and arenaviruses (e.g. lassa) in this regard, and rvfv does not appear at all in its list of potential bioterrorism agents (centre for disease control & prevention ). expert commissions have, however, at times tended to band all vhfs together, resulting in legislation that has overplayed the specific risk of rvfv to human health (borio et al. ) . for instance, the us national institute of allergy and infectious diseases, using the same categorisation as the cdc, includes rvfv specifically as a category a agent thus incorrectly implying high pathogenicity and high human-to-human transmissibility (national institute of allergy & infectious diseases ). while it is not inconceivable that a variety of state and non-state actors may attempt to develop rvfv as a biological weapon, its large scale effectiveness seems limited to causing economic damage through the deliberate infection of livestock (borio et al. ) . in the event that the virus was selected for development as a bioterrorism agent, the current wide ranging restrictions placed on legitimate scientists and vaccine/diagnostic kit manufacturers working with the virus are unlikely to act as a significant deterrent to entities determined to obtain live rvfv samples for culture and study. with the virus so widespread in so many parts of africa, obtaining live samples from an array of vertebrate hosts and culturing it thereafter is a relatively simple process (box ) (us department of health & human services usphs, office of emergency preparedness ). such restrictions thus potentially hinder the development of necessary biological solutions for wider disease control and also provide a false sense of security. bunyaviruses, like rvfv, are known to be easily cultivated in vitro and can therefore be prepared in large quantities (sidwell & smee ; pepin et al. ) . with new advances in recombinant techniques, there may thus be a heightened sense of wariness around the potential for a more pathogenic (to humans) variant of the virus being produced by bioterrorists. for rvfv in particular, this is tempered to an extent in comparison with other bunyaviruses as it is believed to have a relatively low tolerance to genetic mutation (pepin et al. ). as such, while it is important to recognise that evolving technologies mean that rvfv still poses a theoretical bioterrorism risk, it is arguably more important to recognise that the virus causes very real morbidity and mortality naturally and that this consideration should take precedence in the worldwide approach to combating the disease. rift valley fever virus disease hurts some of the most impoverished communities in the developing world through both its direct health and indirect economic effects and is an infection that has suffered decades of chronic under-investment in its control. in recent years, there has been a welcome increase in interest globally in combating this disease, and these efforts should be encouraged. however, to fully benefit from this increased interest, international policies related to biosecurity concerns around the virus should be revisited and tempered. this would not only enable better, more efficient focus on pathogens that do constitute a significant biosecurity risk, but also importantly, allow the global community to accelerate the progress being made towards improving rvfv control. centre for disease control and prevention ( ) national select agents registry animal and plant health inspection service, centre for disease control and prevention ( ) faqs concerning security risk assessments prediction, assessment of the rift valley fever activity in east and southern africa - and possible vector control strategies hemorrhagic fever viruses as biological weapons centre for disease control and prevention ( ) bioterrorism agents/diseases. cdc, available at niaid category a, b, and c priority pathogens. niaid national select agent registry ( ) hhs and usda select agents and toxins. cfr part rift valley fever virus (bunyaviridae: phlebovirus): an update on pathogenesis, molecular epidemiology, vectors, diagnostics and prevention viruses of the bunya-and togaviridae families: potential as bioterrorism agents and means of control responding to the consequences of chemical and biological terrorism. us department of health and human services usphs key: cord- -mtxdn ks authors: oppong, joseph r.; mikler, armin r.; moonan, patrick; weis, stephen title: from medical geography to computational epidemiology – dynamics of tuberculosis transmission in enclosed spaces date: journal: innovative internet community systems doi: . / _ sha: doc_id: cord_uid: mtxdn ks medical geographers study the geographic distribution of health and health-related phenomena such as diseases, and health care facilities. seeking to understand who is getting what diseases or health services where and why, they examine spatial disparities in access to health care services, and the geographic distribution of health risks. medical geographers apply tools of geographic enquiry such as disease mapping and geographical correlation studies to health-related issues (elliot et al., ; pickle, ). some have called this research endeavor spatial epidemiology (cromley, ; rushton, a). medical geographers study the geographic distribution of health and health-related phenomena such as diseases, and health care facilities. seeking to understand who is getting what diseases or health services where and why, they examine spatial disparities in access to health care services, and the geographic distribution of health risks. medical geographers apply tools of geographic enquiry such as disease mapping and geographical correlation studies to health-related issues (elliot et al., ; pickle, ) . some have called this research endeavor spatial epidemiology (cromley, ; rushton, a) . disease mapping is an important tool for medical geographers. such maps help to identify associations between disease and related factors such as environmental pollution. inevitably, disease maps stimulate the formation of causal hypothesis. by enabling the simultaneous examination of multiple factors associated with disease linked by location, geographic information systems (gis) facilitate medical geography research. in fact, recent developments in gis and proliferation of spatially referenced health data sets are spawning new ways to examine health-related issues. projects such as the atlas of united states mortality have prompted researchers to explore various measures of morbidity and mortality (goldman and brender, ; pickle et al., ) , their visual representation in geographic contexts (james et al., ) , and the application of spatial statistics to morbidity and mortality data (james et al., ; pickle, ; rushton ) . gis has revolutionized the way researchers explore the geography of health (gatrell, ; gatrell and senior, ; , and their utility for the study of health issues is widely documented (de lepper et al., ; de savigny and wijeyaratne, ; scholten and de lepper, ) . gis and health research focuses on the quantitative analysis of health-related phenomena in spatial settings (gatrell and senior : ) and, thus, isolates locations of health-related phenomena for analysis and interpretation. while gis has enabled medical geographers to address previously inconceivable complex health-related phenomena, their ability to deal with the dynamic processes of disease transmission among population groups, which usually requires complex interactions among numerous variables, is quite limited. high performance computing provides the requisite tools for breaking this barrier and is the focus of a new field of endeavor that we have called computational epidemiology. although the role of epidemiologists and medical geographers has become more pronounced in light of public health threats, computational tools that would enhance quality of information, facilitate prediction, and accelerate the generation of answers to specific questions are still lacking. in fact, at a time when global health threats make precise epidemiological information a critical necessity, epidemiologists continue to draw conclusions and make predictions using sparse, widely dispersed, incomplete or compromised data. meanwhile, the complexity surrounding disease diffusion continues to escalate. diverse populations traveling extremely long distances in unprecedented short times due to increased globalization mean that disease causing organisms circulate freely in a rapidly shrinking global village. an imperative response is to develop new tools that leverage today's cyber infrastructures for disease tracking, analysis, surveillance, and control. the ability to predict how a disease might manifest in the general population is essential for disease monitoring and control strategies. traditionally data collected during previous outbreaks are used. however, for newly emerging or re-emerging infectious diseases, such data is often unavailable or outdated. changes in population composition and dynamics require the design of models that bring together knowledge of the specific infectious diseases with the demographics and geography of the region under investigation. new scientific methods that enhance understanding of the intricate interplay of disease and population are needed. in a world of bioterrorism, where new and reemerging local disease outbreaks threaten all mankind, disease monitoring cannot continue to be fragmentary and inadequate focusing on small spatial domains (cdc ) . as the recent outbreak of severe acute respiratory syndrome (sars) showed, effective surveillance is critical to an effective defense against global disease threats, and requires consideration of huge volumes of data from other parts of the world. developing tools that will accelerate epidemiological research, disease tracking and surveillance is thus, imperative. computational models for the simulation of global disease dynamics are required to facilitate adequate what-if analyses. what is needed is a novel interdisciplinary research program that facilitates epidemiology and medical geography research through high performance computing (hpc). specifically, we envision the collaboration of biologists, medical geographers, epidemiologists, computer scientists, biostatisticians, and environmental scientists to develop and implement computational tools in support of epidemiological research. these tools include simulation, visualization, and analysis tools that require hpc infrastructure. researchers in computational biology and medical informatics have relied on the availability of hpc infrastructures consisting of parallel computing architectures, cluster computing, and high performance visualization. computational biologists have concentrated primarily on computational models at the molecular level, addressing specific computational problems in genomics, proteomics (protein folding), drug design etc. most notable is the use of hpc in the design of drugs to cure or prevent specific diseases such as hiv. the field of medical informatics, particularly in europe, has utilized hpc to manage the vast volumes of patient data. further, hpc and high performance visualization tools have been used to design medical devices and test their functions in a simulated environment. to the best of our knowledge, there exists no single comprehensive program that aims at utilizing hpc in the field of epidemiology or medical geography to build and analyze computational models of how a given disease manifests in the general population. this may include models of tuberculosis (tb) outbreaks in different environments (homeless shelters, factories etc.), a west nile virus outbreak in a specific geographic region, or the progression of infectious diseases such as measles in the united states. for these models to yield adequately precise information, many different factors must be considered. these factors may include socio-economic status of geographic regions, travel behavior of people, or airflow in a factory building. this clearly requires the use of a computing infrastructure that is capable of yielding computational results in a reasonable amount of time. to interpret the data, visual metaphors or data visualization that permits the epidemiologist to interact with the data are needed. for example, we envision an investigator immersed into a simulated model of a factory in which a tb outbreak is being investigated. the scientist is thus able to interact with the model, change functional parameters and thus engage in a what-if-analysis that currently is not available. one computational challenge is to combine the spatially and temporally disparate datasets. this necessitates a fundamental knowledge of database systems, data management, and data retrieval. even if a comprehensive dataset, containing individual health data for a large section of the population could be constructed, the extraction of relationships among the data constitutes a second computational challenge. for example, the domain of artificial intelligence and machine learning has been successfully used in bio-informatics and is likely to be a valuable tool for discovering relationships among epidemiological data. geographical information systems (gis) help visualize spatial relationships of epidemiological data. whereas the collection of epidemiological data is essential for research, the need for homeland security, disease tracking and surveillance requires sharing data among different federal, state, and local agencies. healthcare providers in hospitals and private practice may be required to provide information to respond quickly and decisively to possible community health threats. a corresponding communication infrastructure can dramatically improve the precision with which health threats are analyzed, predicted, or traced. such a system requires the combined effort of epidemiologists and computer scientists, each with a detailed understanding of each other's domain. for instance, issues that are central to the analysis of health-related data may dominate the requirements for a network infrastructure to interconnect healthcare providers. examples of such issues include the type of information to be shared, format of information, and possible privacy and security issues. recent breakthroughs in sensor technology and wireless communication have led to the concept of sensor networks. sensors of different types (biological, chemical, physical) have been deployed to monitor conditions in a variety of diverse environments. ecologists, meteorologists, soil scientists, and others rely on such sensors to collect information about the environment. connected via wireless networks, sensors can cover extended geographic areas, generating information instantaneously. the national science foundation (nsf) has announced special interdisciplinary programs to advance the field of sensor networks at a fast pace. this technology facilitates the monitoring for biological and/or chemical agents, and is expected to play a major role in homeland security. environmental surveillance is essential in the field of public health, as it leads to early detection of adverse conditions and hence the ability to alert the population. however, to optimize this technology, scientists need to understand the technical (computational) as well as the epidemiological domains. new algorithms that autonomously extract data from sensors and auto-correlate sensor events must be developed. this leads to the design of intelligent systems, capable of learning from sensor data, and being able to classify events expediently. another example of convergence of epidemiology and computer science is the modeling and simulation of infectious disease outbreaks. such an endeavor requires modeling demographics of the geographic domain within which a simulated outbreak is to take place. it further requires a high-fidelity representation of the disease pathology. although very small models may be executed on a single computer, the simulation of a geographic region of moderate size will require computational resources beyond those of a single workstation. this leads to the use of a high performance computing infrastructure or computing clusters with tens or even hundreds of processors. similar to computational biology and bio-informatics, computational epidemiology can utilize modern communication and computation infrastructures to solve computationally complex problems. the next generation of national (and international) cyber-infrastructure to provide access to high-bandwidth networks and high performance computing is about to be developed. the field of epidemiology must develop tools that will enable scientists to effectively use such an infrastructure. to illustrate the need for computational epidemiology, two case studies are presented below. the dynamics of localized tb transmission within enclosed facilities such as homeless shelters or factories is little understood. traditional medical geography, involving disease diffusion mapping precludes detailed analysis of the dynamics of tb transmission in enclosed spaces. for example, the spatial patterns of individual movement, pathogen characteristics, airflow and other specifics of the facility that trigger transmission are not easily modeled in a gis. the case studies cover tuberculosis transmission in a factory and a homeless shelter. results of initial analysis suggest that proximity of workspace to infected person is a major determinant of infection. after showing the shortcomings of traditional medical geography and disease mapping for modeling dynamics of disease transmission, preliminary results of a simulation model using advanced computational tools, are presented. the new tool of computational epidemiology allows the spatial distribution of risk to be defined not in terms of large regions but in micro-space, literally feet and inches. the potential of such computational tools for disease transmission in enclosed spaces is demonstrated. the number of tuberculosis cases in the united states is at its lowest point in history, with , cases reported in and a tb case rate of . per , [ ] . consequently recent research suggests that molecular based studies focusing on dynamics of tb transmission in specific locations, such as homeless shelters, and social settings such as bars [ , , ] is a much-needed final push to tb control. for example, the homeless and those living in marginal housing and overcrowded areas [ ] constitute reservoirs of tb infection. recent research conducted in los angeles and houston suggest that locations at which the homeless congregate are hot spots of tuberculosis transmission, and measures that reduce tuberculosis transmission should be based on locations rather than on personal contacts [ , ] . yet, little research exists on the dynamics of localized tb transmission within a homeless shelter or other enclosed facility. while much emphasis has been placed on homeless shelters, little attention has been paid to other enclosed facilities such as factories, warehouses and classrooms where long-term exposure usually in close contact situations that may facilitate transmission of pathogens, is usually the norm. for example, tuberculosis transmission is a recognized risk to patients and workers in health-care facilities (cdc ) . factories and warehouses, where people usually work in close proximity for long periods, may also be areas of concern. methodology data for these case studies were based on data collected prospectively on all persons newly diagnosed with culture positive tuberculosis at the tarrant county health department (tchd) between january , and december , . each eligible patient was prospectively enrolled and participated in a structured interview as part of their routine initial medical evaluation. as part of an on-going center for disease control and prevention (cdc) study of the molecular epidemiology of tuberculosis, all positive isolates obtained from persons residing in tarrant county are sent to the texas department of health (tdh) for dna fingerprinting. all patients are interviewed at the time of the initial evaluation, using a data collection instrument designed to obtain demographic information and medical history. the results of the dna fingerprinting were incorporated into the database using patient identification numbers. epidemiological factors included in this study were age, country of birth, date of entry, race/ethnicity, onset of symptoms, date of diagnosis and physical address. any patient who did not have both pcr-based spoligotyping and rflp-based is analysis performed on their corresponding mtb isolate, and/or did not live within tarrant county at the time of collection were excluded from the geographical analysis. m. tuberculosis culture isolation, identification, and drug susceptibility was conducted at the texas department of health bureau of laboratories. clinical isolate is -based rflp and pcr-based spoligotyping methods were utilized to identify patients infected with the same m. tuberculosis strain using published methods (van embden jd, et al., ; kamerbeek, et al., ) . since the discriminatory power of the is probe is poor for strain differentiation among specimens with five or fewer of the insertion elements, additional genotyping using the pcr-based spoligotyping was utilized (kamerbeek, et al., ) . we consider isolates representing a cluster when two or more patients had identical number of band copies, is -rflp, and spoligotyping patterns. the first case study describes the dynamics of tuberculosis transmission within a homeless shelter with beds providing both long and short-term occupancy for homeless people in tarrant county, texas. we seek to understand how location within a homeless shelter influences risk of tuberculosis infection. the data set comprises screening records for each case including age, race, date tested, status of tuberculosis, location in the facility, length of time spent in the facility, and other variables. within the shelter the beds can be assigned to major areas -men's mats, men's beds, men over , female mats and females over beds. each of these areas varied in bed density, floor space and occupants (figure ) . the mats area, (both male and female), is occupied by transients with no regular source of food, shelter, or shower. the beds and over areas (male and female) are less dense overall, with more permanent residents. results of initial analysis suggest that tb risk is not uniformly distributed but depends on the location of the sleeping bed and duration and frequency of stay at the night shelter. for example, of the active cases ( . %) had been visiting the shelter for more than years. we need to examine certain dynamics of the homeless shelter that promotes or inhibit tb transmission such as the air circulation system. for example, while the men's and women's areas had different airflow systems, it appeared that air flow in the women's section was more effective than in the men's section. is this a factor in tb transmission? the movement patterns of residents also need to be addressed. how much time do they spend in common areas such as the dining area, the smoking area, the tv area and rest rooms? another factor to consider is the lighting in different parts of the homeless shelter. does the heat put off by the lighting affect dispersion of the bacilli? addressing all of these is clearly beyond the capacity of any gis or simple disease mapping. hpc is required to simulate the movement pattern of residents, tb bacilli, lighting, the air circulation system and other variables. the second case study covers tb outbreak in a factory that produces airplane bridges. out of a total of workers, were ultimately infected with the same strain of tb presumably from one index case (table ) . in the factory, figure , in addition to basic screening records as collected for the homeless shelter, other available data include measures of duration and proximity to infected person such as hours per week in the factory, hours per week in the same workspace, hours per week within feet of infected person, and usual work area. results of initial analysis suggest that proximity of workspace to infected person was a major determinant of infection. in fact almost % of those who worked directly in the same space with one infected person were infected with the same strain of tb. hours spent each week in the factory was not a statistically significant determinant of tb risk. rather, hours spent in the same work space and hours spent within feet of index case were the significant determinants of risk. in short active tb risk in the factory depends not so much on time spent in the factory but on time spent where in the factory. simple mapping of tb occurrence in the factory does not go far enough. we need to simulate actual transmission considering factors such as the dynamic movements of individuals in the factory, shared common areas and amount of time spent there, the air circulation system, and related variables. clearly more sophisticated tools are required to handle multiple variables in a dynamic system. this rich data set provides the opportunity to implement a model to calibrate the dynamics of tb transmission in enclosed facilities using computational epidemiology. this study examined tuberculosis transmission in a homeless shelter and a factory with ongoing tb transmission. to understand the dynamics and determinants of transmission in enclosed spaces, traditional medical geographic approaches such as gis are not suitable for modeling dynamics of disease transmission. computational epidemiology allows the spatial distribution of risk to be defined not in terms of large regions but in micro-space, literally feet and inches. the potential of such computational tools for simulating and explaining disease transmission in enclosed spaces is high. zip-code level risk factors for tuberculosis: neighborhood environment and residential segregation in new jersey, - transmission of tuberculosis among the urban homeless guidelines for preventing the transmission of mycobacterium tuberculosis in health-care facilities, . mmwr reported tuberculosis in the united states the added value of geographical information systems in public and environmental health gis for health and the environment sex, gender and tuberculosis geographies of health: an introduction health and health care applications are stanardized mortality ratios valid for public health data analysis an analysis of lung cancer on a microgeographical level a brief visual primer for the mapping of mortality trend data networks and tuberculosis: an undetected community outbreak involving public places a cluster of tuberculosis among crack house contacts in introduction to geographic information systems in public health introduction to geographic information systems in public health spatial analysis of disease atlas of united states mortality. u.s. department of health and human services, public health service, centers for disease control atlas of united states mortality. u.s. department of health and human services, public health service, centers for disease control exploring spatial patterns of mortality: the new atlas of united states mortality geographic information systems and public health geographic information systems and public health epidemiology and biostatistics: public health, gis, and spatial analytic tools public health, gis, and spatial analytical tools the benefits of the application of geographical information systems in public and environmental health complex transmission dynamics of clonally related virulent mycobacterium tuberculosis associated with barhopping by predominantly human immunodeficiency virus-positive gay men key: cord- -v wlz fa authors: merianos, angela; peiris, malik title: international health regulations ( ) date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: v wlz fa nan moderate exercise (eg, % of maximal capacity) and platelet adhesion reduces with regular exercise. although blood pressure often rises acutely during exercise, this response is attenuated by regular exercise. because reduction of peripheral vascular resistance was thought to be the principal mechanism for acutely lowering blood pressure with exercise, a reduction in cardiac output, stroke volume, and left ventricular end-diastolic volume were found to account for much of the acute blood pressure reduction after exercise in older people with hypertension. regular exercise improves myocardial contractility and coronary perfusion. in fact, exercise improves arterial compliance and endothelial function, in general. it is thought that greater sheer stress with exercise enhances synthesis of nitric oxide from endothelial cells. this nitric oxide might also slow the development of atherosclerosis, as well as reducing the risk of acute coronary events by relaxing smooth muscle and inhibiting the proliferation of smooth muscle, platelet aggregation, and leucocyte adhesion to vessel walls. regular moderate exercise can also reverse left ventricular hypertrophy. despite modest long-term compliance, advice to exercise has been shown to be effective and cost effective at increasing overall exercise levels for at least months, without adverse effects. for the people who can comply, adding exercise prescriptions to the management of hypertension has the extra value of reducing drug-related costs and adverse effects, and at the same time improving cardiovascular risk. thus the recommended exercise prescription for lowering blood pressure in hypertensive patients can be tailored, and can involve any intermittent or continuous aerobic activity of at least min a day, three or more times a week. on may , , the th world health assembly, consisting of the member states of who, adopted the revised international health regulations (ihr), the code of international regulations for the control of transboundary infectious diseases. the spread of severe acute respiratory syndrome illustrated the rapidity with which a new infectious disease can spread and affect today's interconnected world. the deliberate release of anthrax in the aftermath of the events of sept , , highlighted another dimension of microbial threats. neither event was adequately addressed in the previous ihr of . the key constraints of ihr ( ) were the limited scope of diseases (cholera, plague, yellow fever), the dependence on official notification to who by affected countries, the scarcity of mechanisms for collaboration in investigating such outbreaks, and the lack of specific riskreduction measures to prevent the international spread of disease. indeed, there was disincentive to reporting under the ihr because unaffected countries applied travel and trade restrictions far in excess of the true risks of the disease. the new ihr goes some way toward addressing these issues by establishing expert panels to review the risks to international public health and recommend evidence-based control measures. however, even the revised ihr show an inevitable compromise between national sovereignty and the collective international good; of trying to ensure the maximum security against the international spread of disease with minimum interference to travel and trade. new infectious diseases have been emerging at the unprecedented rate of about one a year for the past two decades, a trend that is expected to continue. , in the past years, new and emerging infectious diseases with a potential threat to international public health include ebola, lassa, and marburg haemorrhagic fevers in africa, variant creutzfeldt-jakob disease in europe, meningococcal meningitis w associated with returning hajj pilgrims, nipah virus in malaysia, west nile virus in the americas, severe acute respiratory syndrome, and the pandemic threat from avian influenza h n in asia. there is clearly a need for new approaches to confront these emerging threats from infectious disease. in , the who department of communicable diseases surveillance and response in geneva initiated the formation of the global outbreak alert and response network (goarn), which provides the operational and technical response arm for control of global outbreaks. in - , goarn responded to events in countries, and has grown to a partnership of over institutions and networks, including un and intergovernmental organisations. the network provided substantial support to affected countries during the outbreak of the severe acute respiratory syndrome and in response to avian influenza. it was clear that the ihr ( ) also needed to change to allow response to contemporary threats to international health. efforts towards achieving this response began in . the purpose and scope of the ihr ( ) are to prevent, protect against, control, and provide a public-health response to the international spread of disease in ways that are commensurate with and restricted to publichealth risks, while avoiding unnecessary interference with international traffic and trade. the ihr ( ) affirm the continuing importance of who's role in global outbreak alert and response to public-health events. the revised ihr spell out the responsibilities for who, other international agencies with a mandate to protect public health (including radiation health and chemical safety), and the member states themselves. a decision instrument has been developed to assist countries in determining whether an unexpected or unusual public-health event within its territory, irrespective of origin or source, might constitute a public-health emergency of international concern and require notification to who. criteria include morbidity, mortality, whether the event is unusual or unexpected, its potential to have a major public-health effect, whether external assistance is needed to detect, investigate, respond, and control the current event, if there is a potential for international spread, or if there is a significant risk to international travel or trade. the ihr ( ) explicitly recognise the need for intersectoral and multidisciplinary cooperation in managing risks of potential international public-health importance. key partners include intergovernmental organisations or international bodies with which who is expected to cooperate and coordinate its activities: eg, the un, international labour organization, food and agriculture organization, international atomic energy agency, international civil aviation organization, international committees and federations of the red cross and red crescent societies, and office international des epizooties. the revised ihr set out core capacities of a country's preparedness to detect and respond to health threats-early events detected by national surveillance system unusual diseases which must be notified: smallpox wild poliovirus human influenza (new subtype) severe acute respiratory syndrome any event of potential international public-health concern known epidemic-prone diseases which must be notified: cholera pneumonic plague viral haemorrhagic fevers yellow fever west nile fever other locally or regionally important diseases if yes to any two of these questions is public-health impact of event serious? is event unusual or unexpected? is there significant risk of international spread? is there significant risk of international travel or trade restrictions? figure: simplified decision instrument for assessment and notification of events that might constitute public-health emergency of international concern under international health regulations ( ) warning and routine surveillance systems, epidemiological and outbreak investigation skills, laboratory expertise, information and communication technologies, and management systems. who will continue its traditional role of providing support for national capacity building to achieve these core capacities. a short list of diseases (figure) needing mandatory notification to who are included in the decision instrument; however, countries are now also required to assess the international public-health threat posed by any unusual health event, including those of unknown causes or sources, and outbreaks caused by agents with the known ability to cause serious public-health effect and to spread rapidly internationally. importantly, who can now use a range of sources of health intelligence to raise an alarm and begin a process of verification with countries that have not voluntarily reported significant health events. parties capitalised to the ihr are required to inform who within h of the receipt of evidence of a public-health risk that might cause international spread of a disease. finally, if who obtains credible evidence that a public-health event of international importance has occurred and fails to obtain disclosure and cooperation by the affected state, it has discretionary power to release the public-health information required to protect global public health. the ihr work on the principle of global public goodprotecting public health through early detection and response to public-health emergencies benefits the nation concerned and reduces the risks of spread to other nations. their impact will be limited unless national governments accept their global public-health responsibilities. furthermore, because most human emerging infectious diseases are zoonotic in origin, there is a need for close collaboration between the veterinary, human health, and wildlife sectors. the regulations of the office international des epizooties, the veterinary counterpart of the ihr, face similar challenges as did the ihr ( ), and perhaps need a similar overhaul. the problems currently faced in confronting the threat to human and animal health posed by the outbreaks of avian influenza a h n in asia amply illustrate this contention. the ihr ( ) will enter into force in . effects of an intensive diet and physical activity modification program on the health risks of adults management of hypertension in older persons the acute versus the chronic response to exercise the role of exercise training in the treatment of hypertension: an update exercise characteristics and the blood pressure response to dynamic physical training accumulating brisk walking for fitness, cardiovascular risk, and psychological health auckland: faculty of medicine the effectiveness of exercise training in lowering blood pressure: a meta-analysis of randomised controlled trials of weeks or longer effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials exercise and hypertension dose-response and coagulation and hemostatic factors postexercise blood pressure reduction in elderly hypertensive patients physical activity and cardiovascular disease effectiveness of counselling patients on physical activity in general practice: cluster randomised controlled trial world health organization. fifty-eighth world health assembly resolution wha . : revisions of the international health regulations world health organization microbial threats to health: emergence, detection and response world health organization. fifty-fourth world health assembly resolution wha . global health security: epidemic alert and response global outbreak alert and response: report of a who meeting world health organization. fifty-first world health assembly. revision of the international health regulations: progress report global public goods for health: health economics and public health perspectives global task force for influenza the nomenclature of epileptic seizures has always been confusing. many historic terms, still in use by the public and even by some physicians, convey little information about the anatomy or physiology of the event. "grand mal" and "petit mal" are hardly preferable to the simpler "big" and "little". in the international league against epilepsy (ilae) formed a commission to develop improved terminology, which led to the international classification of epileptic seizures (ices), last revised in . this document was supplemented in by the international classification of epilepsies and epilepsy syndromes, which takes into account causation and other clinical features. in the ices scheme, the fundamental dichotomy is between "partial" seizures (arising in a focal area of the brain) and "generalised seizures" ("those in which the first clinical changes indicate initial involvement of both hemispheres"). despite decades of effort, the ices terms remain hard to explain to naming seizures key: cord- - uey ou authors: mulvad, gert; petersen, henning sloth; olsen, jørn title: arctic health problems and environmental challenges in greenland date: journal: arctic alpine ecosystems and people in a changing environment doi: . / - - - - _ sha: doc_id: cord_uid: uey ou nan the traditional diet in greenland is to a large extend based upon marine animals and fish (deutch ) . today the greenlandic diet is a mixture of traditional food and imported food, this is the way it has been for some generations. due to weather conditions most of fresh food come from wild animals or fish. greenland has a production of lamb and a limited supply of vegetables but most produced foods are imported from outside. a large part of the diet still stem from seafood, fish or sea animals, but imported fabricated foods are expected to continue to take over an increasing part of their energy consumption (deutch , mulvad . in any community it is important how food is produced, how it is prepared and how it is consumed. these things are important to the individual and for the way people come together. that is why food is more than just getting the necessary nutrition, it is also essential for social life and the ways families function. since food is increasingly imported and come in full or almost full fabricated forms the quality of nutrition changes. along with this public health may be affected as well as the social aspect of eating and preparing the meals. still the traditional diet is very important to the population culturally and financially. it is also of importance in order to get sufficient nutrients, because in many places imported food is available mostly in poor quality (deutch , pars . high levels of long range transported contaminants to the arctic have been documented by (amap ) . in greenland high contents of organic contaminants are found in people , deutch and the pollution has reached a level of concern. however, the replacement of traditional food by substandard, imported food is of significant concern. pollutants that accumulate in this part of the food chain can best be studied in the inuit population. other dietary studies focusing upon a diet rich in fat, like n- fatty acids, have been subject to study (dyerberg ) . however, much more could be done. the partly isolated inuit population with its ethnic background provides new opportunities for genetic studies, as well as studies on the health impact of unique social circumstances, light and extreme cold weather. greenland is now in a transition between a disease pattern characterized by acute diseases, mainly infections, and chronic diseases, diabetes and cardiovascular diseases. this transition took place in europe many decades ago but now we have a chance to study the process with modern technology. organization and logistic of the health care system in sparsely populated arctic regions is of great interest. further more greenland has public health problems which more than anything require a long term strategy for prevention. a common problem for some environmental contaminants is that they have natural half lives of many years. they are also long range transported and can cause problems for generations. contaminants examined by the arctic monitoring and assessment program, (amap), are pcbs, pesticides such as ddt, hcb, hch, chlordane, dieldrin and toxaphene, and heavy metals. the persistent organic pollutants (pops), are accumulated in the food chain in fatty tissue, creating the highest levels in orsoq/blubber from seals and tooth whales. barleene whales, however, have a lower place in the food chain and are therefore less contaminated. the highest levels are also found in the oldest individuals. humans and polar bears are at the top of the food chain, and are thus highly exposed to these chemicals (neri ) . generally the levels are low in fish from greenland and it is not a problem to eat greenlandic fish. in the baltic there has been found levels in seals up to times higher than along the coasts of greenland, but in the countries around the baltic, seals are not eaten. currents in the sea and in the air spread the contaminants unevenly so that seals and people along the east coast of greenland are more exposed to most pops (deutch . in greenland, research on mercury is extensive. mercury is a heavy metal that has always been in the environment, it also constitutes a pollution without borders. mercury levels in blood from greenlandic people are some of the highest measured in human samples (hansen et al. ). mercury level are some of the highest measured in human samples. (mulvad, pedersen, hansen et al. ) lead is a well known contaminant that may stem from hunting bullets (neri ) or from petrol and gasoline. cadmium comes mostly from smoking cigarettes. the high smoking frequency in greenland creates rather high blood levels in greenlandic people in general. heavy metals are accumulated on their way through the food chain and are also accumulated in human tissues. it is not dangerous for adults to eat the traditional food and the change from traditional diets to westernized macdonalization may be a poor option concerning health. it is in relation to pregnant women and especially unborn babies that contaminants cause concern. clinical studies have shown an effect on the ability to learn and on memory, as a function of exposure to e.g. mercury early in life (weihe et al. ) . some surveys indicate that the hormone balance and the immune system may be affected, i.e. the ability to fight infections (amap ) . some of these effects may perhaps be counteracted by the fatty acids in sea mammals. as the woman accumulates contaminants throughout her life, contaminants will be present in the body even if the diet is changed during pregnancy (deutch ) . some surveys also suspect pops for affecting the quality of sperm (abell et al. ) . the traditional greenlandic diet, where sea mammals are dominant, provides heat, energy and a healthy diet, at least for physical active people (pars , dyerberg et al. ; the well known fat from sea mammals protects against coronary heart diseases and possibly also immune and inflammatory diseases. a great amount of evidence from epidemiological studies and clinical trials support a theory of protective effect against coronary heart disease for fish consumption and intake of marine omega- fatty acids (jul et al. , pedersen . biological pathways for this risk reduction include membrane stabilization in the cardiac myocite, inhibition of platelet aggregation, favorable modifications of the lipid profile, decrease in blood pressure and reduction of the inflammatory response of the endothelium. results from epidemiological studies suggest a threshold effect for the consumption of fish and omega- fatty acids. relative concentrations are expressed as the percentage of total acids in plasma phospholipids. this number represents all women who were within the same group of age risk reduction is especially important for cardiac sudden death. nevertheless, protection against non-fatal coronary heart disease has also been observed . menstrual discomfort in danish women reduced by dietary supplements of seal oil capsules. shown in a trial done in aarhus university . omega fatty acid may also help prevent pre-term births (olsen et al. ) . selenium is an important vitamin which limits the effect of mercury. a number of other vitamins and trace elements are well represented in the traditional diet and at the same time it is a diet which is high in protein and low in sugar. it is a diet well suited for physical active hunters living in the cold arctic environment. vitamin d is obtained from dietary sources and from endogenous synthesis in the skin. dietary sources rich in vitamin d are fat fish and sea mammals. ordinary meat, milk and eggs contain less vitamin d and vegetables are void of vitamin d. the endogenous synthesis occurs in the skin under ultraviolet light b (uvb) stimulation. the endogenous production depends on sun exposure, age, clothing, skin pigmentation, and use of sun protection. the exposure to uvb depends again on latitude, solar height, absorption in ozone layer and atmosphere, and reflection from clouds. in greenland, protective clothing is customary, and summer is short with a low solar zenith altitude thus, yearly exposure to uvb-sunlight is limited. however, the traditional inuit diet is rich in sea mammals that contains large quantities of vitamin d. during the last decades, significant cultural changes have occurred in greenland. today, many greenlanders are living on a westernized danish diet that is low in natural dietary sources containing vitamin d furthermore, danish food is not fortified with vitamin d. changes from a traditional-to a westernized-fare are associated with a reduced vitamin d status in greenlanders, especially in winter time. (rejnmark et al. ). the influence of age, gender, latitude, season, diet and ethnicity on plasma -hydroxy-vitamin d ohd was studied showing that in addition to ethnicity (danes versus greenlanders), ohd levels were influenced by age, season (summer > winter), and diet (a traditional inuit diet > westernised diet). a longitudinal study on osteoporosis was conducted in nuuk, in september . the objective was to evaluate risk factors of osteoporosis and changes in parameters of ultrasound densitometry, after two years, among perimenopausal inuit women who previously participated in a cross section study. after two years, the prevalence of osteoporosis has doubled. moreover, the study suggests an association between smoking and change in stiffness, and mono-ortho pcb congeners concentration was strongly and negatively associated with bone stiffness (cote et al. ) . the first known immigration was by eskimos who came from the west more than . years ago, and since then there has been immigrations by eskimos and their descendants -inuit -the latest only about years ago. from the east came the vikings . years ago, but they disappeared after a few hundred years, perhaps without leaving any genetic trace. until the s, only - % of the greenlandic population were non-greenlanders, so a major genetic influence on the inuit tribe has only taken place during the last decades, where especially in the s and s a stream of laborers, employers and academics invaded the country and with an overweight of younger virile men that made significant marks not only on the color of the kids today, but also resulted in relative depletion of greenlandic females. in spite of common beliefs these bureaucrats and craftsmen were more successful in spreading their genes than the vikings. more than % of the population were foreigners at that time. since the late 's, the ratio has slowly decreased. looking at the diversity in samples of greenlandic inuit shows % of the y chromosomes have been assigned to european origin in contrasts with a complete absence of european mitochondrial dna, it indicates a male-biased european admixture. (bosch et al. ). greenland is now in a transition between a disease pattern characterized by acute diseases, mainly infections and chronic diseases, diabetes and cardiovascular diseases. after world war measles epidemic, tuberculosis, sexual transmitted diseases and hepatitis has been described. the lifestyle of the inuit is in the same period undergoing a rapid transformation, like in most other countries that are not isolated from the rest of the world. these transitions also influence health parameters in greenland. infections are still frequent, especially acute respiratory infection, hiv, chlamydia, (koch , homoe . we also se an increase in the food born infections due to the increase of imported food. the effect of the western lifestyle, obesity and central fat pattern are associated with several cardiovascular risk factors including diabetes, hypertension and dyslipidemia. central fat patterns and obesity are more prevalent among the inuit compared to the danish population . for obvious reasons, experience in how to establish an efficient and competent public health system in sparsely populated arctic regions is of great interest in the northern part of north america as well as in northern europe and russia. it is also a well known fact that technology from one area cannot necessary be transferred from one area to the next. since most of health technology is developed by means of research in technically advanced settings we face a shortage a knowledge for how best to modify and transfer this technology to quite different settings. greenland is the largest island in the world covering . million sq. kilometers of which % is covered by ice, and % is a narrow strip of land along the coastline. the climate is arctic. about . inhabitants are settled in towns and settlements along a coastline of . km. the towns have - . inhabitants with the exemption of the capital, nuuk, that has . inhabitants. about % of the total population live in settlements with to inhabitants. health care takes place in district medical centers, one for each town including its settlements. nuuk has a central hospital for specialized treatment, and one of the university hospitals in copenhagen (rigshospitalet) is used for more intensive care or specialized treatment. the district medical centers are basically autonomous units. depending on the population, there are - physicians, nurses, midwifes, health care assistants, labtechnicians, translators, secretaries and others. typically, the doctors and nurses are danish and the rest greenlanders. in the smallest district, a doctor and a nurse are the only medically trained personnel. a district has from to surrounding settlements to look after, and the distance can be kilometers. boats and dog sledges can be used for transport, but in many emergency cases only helicopter is an option, and a helicopter is often placed far away. the cost for an emergency transportation can be very high. the advantage of the health care system is the very close contact between the health care staff and the patients. the staff members are themselves part of the local communities and usually know their patients well. this contact is key to optimize immunization programs pr treatment modalities for venereal diseases, diabetes and mental diseases. also the close relation to the social care system, police and institutions has advantages. the staff should be in a good position to implement prevention and more comprehensive public health programmers when such programmers are formulated by the health care authorities. to strengthen the connections between remote units to the main hospital and to specialists outside greenland, the implementation of telemedicine is now of growing importance. telemedicine is the use of information technology for electronic transmission of information, pictures, sound and other health-related data that is needed to make appropriate diagnosis and treatment plans. based on the experience already obtained with telemedicine in greenland, , there are good reasons to implement telemedicine on a fig. . . telemedicine is important between remote units. larger scale (stensgaard ) . it is important that the results are registered and analyzed currently throughout the period in order to ensure that the experience gained will support the continued use of telemedicine in greenland and also be published to the benefit of others. video-consultations can be established and x-ray photos and electro-cardiograms can also be transmitted. sonography of heart, dermatology and psychiatry are other areas. a common record system will also help provide updated information about each patient. the major characteristic of recent health and social problems in greenland are (compared to denmark): low mean lifetime expectancy, high infant mortality, increasing rates of diabetes, cardiovascular diseases and cancer, high rate of infectious diseases (tuberculosis, hiv, hepatitis b virus infection, helicobacter pylori infection, meningitis), high rate of suicide, high rate of lethal accidents, high rate of legal abortions, domestic violence, tobacco, alcohol and drug abuse, mental health are stressed by unstable family relationships, contamination of the traditional diet (chief medical officer ) . the health of the population does not match the amount of money spend on health care. health expenditure/gdp (per cent) greenland: , , denmark: , norway: , . (health statistic in the nordic countries ). social studies and public health science have to take into consideration the conditions under which people live, e.g. health standards and housing, schools and education as well as social relations should be studied further. we need research in greenland for the people not only on the people, and with the people. lifestyle diseases, the incidence of dental diseases, mental health, various forms of cancer, as well as infectious diseases are important in relation to the well-being and health of the population (lynge . social studies and studies on public health are to a great extent designed to accommodate the specific need for research in greenland (bjerregaard et al. , commission for scientific research in greenland , covered by this strategy within the framework of the effort. to promote health, well-being and economy of the greenlandic population, it is suggest that, within this broad framework, social studies and public health science together encourage research which includes health hazards as an integral part of cultural aspects as well as research on social behavior in general. since many of the problems related to problems that global pollution has reached a level where the environment is affected and there is concern for people and animals that seat on the top of the food chain. replacement of traditional food by substandard, imported food is also of significant concern. any food recommendation must be structured to the community and take into consideration the available sources of food. for this reason it is important to keep monitoring the pollution that accumulates in the food chains and to take this information into consideration together with other available information concerning nutrition. these recommendations have to be well balanced and to incorporate all health aspects of diet and the social and economic consequences of our diet and how we get the food we need to eat. the pattern of disease will be increasingly influenced by chronic diseases being developed over long periods of time. the causes for this may be found early in life; during pregnancy, when all organs are formed, and during early childhood, where habits and the conditions for children form the basis for the future of greenland both economically, socially and for health. the position of the family and the definition of its responsibilities are central matters in this process. time has come to concentrate the effort where it will have the greatest and longest lasting effect. a research program like this one should focus on families who are just starting to have children. research should include genetic, social and cultural aspects on one hand and disease, behavior and cognitive development on the other. research should have a longitudinal angle and should provide possibilities of trying out theory through interventional projects. time has come for the policy makers to think ahead and to make decisions that span more than time periods of election. cultural change and mental health in greenland: the association of childhood conditions, language and urbanization with mental health and suicidal thoughts among the inuit of greenland decreasing overweight and central fat patterning with westernization among the inuit in greenland and inuit migrants studying health in greenland high level of male-biased scandinavian admixture in greenlandic inuit shown by ychromosomal analysis strategi for danskgrønlandsk polarforskning a longitudinal study of bone mass among perimenopausal inuit women of greenland biostatistik og epidemiologisk vurdering af levevis og miljømedicinske data fra grønland. mph thesis high human plasma levels of organochlorine compounds in greenland. regional differences and lifestyle effects menstrual discomfort in danish women reduced by dietary supplements of omega- pufa and b (fish oil and seal oil capsules) dietary composition in greenland , plasma fatty acids and persistent organic pollutants fatty acids composition of the plasma lipids in greenland eskimos arctic monitoring and assessment programme (amap), strategy and results with focus on the human health assessment under the second phase of amap prenatal exposure to methyl mercury among greenlandic polar inuits otitis media in greenland diabetes and impaired glucose tolerance among the inuit population og greenland the relationship between a low rate of ischaemic heart disease and the traditional greenlandic diet with high amounts of monounsaturated and n- polyunsaturated fatty acids a longitudinal community based study of respiratory tract infections in greenlandic children: disease burden and risk factors mental disorders in greenland. past and present the inuit diet. fatty acids and antioxidants, their role in ischemic heart disease, and exposure to organochlorines and heavy metals. an international study contaminants in the traditional greenland diet. ministry of the environment low consumption of seafood in early pregnancy as a risk factor for preterm delivery: prospective cohort study forbruget af traditionelle grønlandske fødevarer i vestgrønland atherosclerose og intracerebral haemorrhagi i relation til fedtsyrasammensaetningen i fedtvaev og validering af dødsårsagsmønsteret atherosclerosis in coronary arteries and aorta among greenlanders: an autopsy study vitamin d insufficiency in greenlanders on a westernized fare: ethnic differences in calcitropic hormones between greenlanders and danes udbygning og styrkelse af det telemedicinske samarbejde i de nordiske og tilgraensende områder neurobehavioral performance of inuit children with increased prenatal exposure to methylmercury the present papers has been supported by the commission for scientific research in greenland, sygekassens helsefond, denmark, greenland home rule. key: cord- -we rp pa authors: koh, howard k. title: leadership in public health date: journal: j cancer educ doi: . /bf sha: doc_id: cord_uid: we rp pa the modern public health model for leadership will unlikely be the omniscient figure with easy answers. rather the public health leader of the future may well be the transcendent, collaborative «servant leader»( , ) who knits and aligns disparate voices together behind a common mission. they pinpoint passion and compassion, promote servant leadership, acknowledge the unfamiliar, the ambiguous, and the paradoxical, communicate succinctly to reframe, and understand the «public» part of public health leadership. by working between and above the levels of leadership of self, others and organizations, these transcendent leaders can ultimately shift the paradigm from «no hope» to «new hope» and create a renewed sense of community. such leadership will be vital as the st century progresses. beginning the journey to new hope may start by motivating underdogs who nurture the spirit, discover a passion to serve, cultivate interdependence, and create uncommon bonds. these emerging leaders can tap into their unique talents, passion, and compassion to promote a mission of «the highest attainable standard of health» for all, in every community. n an ideal world, all people would reach their full potential for health: long life and high-quality lives in healthy communities would allow everyone to reach optimal physical and emotional well-being. unfortunately, however, the harsh reality falls far short of this vision. a dynamic and ever-expanding panoply of health threats poses a host of challenges. dangers range from traditional threats such as infectious diseases and the health needs of mothers and infants to chronic diseases such as cancer and cardiovascular disease, substance abuse, mental illness, hiv/aids (human immunodeficiency virus/acquired immunodeficiency syndrome), and diabetes. rising health care costs and growing numbers of the uninsured represent growing burdens for the united states. the st century has also seen greater emphasis on emerging infections and deadly pathogens that seem only a plane flight away. meanwhile, throughout all areas, health inequities divide the richer and the poorer. , stemming the tide of such daunting challenges in these volatile times will require a renewed commitment to public health leadership. in fact, recent years have seen a crescendo of calls to reinvigorate leadership education and training, because "today, the need for leaders is too great to leave their emergence to chance." - such leaders could help further social justice and the common good by promoting the values captured in the preamble to the constitution of the world health organization-"the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being." to advance such training, the association of schools of public health has identified leadership as a core competency area in the master of public health competency model for . this and other cross-cutting competencies should distinguish the public health practitioner of tomorrow. however, leadership in public health requires stretching the mind and soul in almost unimaginable ways. a good example is dr. harold freeman, a leader who throughout his career has kindled new hope by making cancer prevention and control come alive. dr. freeman started his career as a young surgeon with a simple but profound passion to help people. he went on to attain many distinguished positions of note, including national president of the american cancer society, chairman of the us president's cancer panel, associate director for the national cancer institute center to reduce cancer health disparities, and chief architect of the american cancer society's initiative on cancer in the poor. the power of dr. freeman's remarkable career lies, however, not in his rich array of official titles but rather in his dedication to the broad vision of a world free from cancer. a descendant of a slave who became free and changed his name to "free man," harold refused to be typecast as a stereotypical surgeon. rather, he used his passion and compassion to promote prevention, merging the fields of clinical medicine and public health to do so. even as a young physician, he grasped the power of saving lives through early detection of cancerwhich currently carries a global disease burden of about million deaths per year and is projected to become the leading cause of deaths worldwide by . throughout his career, he not only delivered care for underserved individuals but also promoted early detection for all. in struggling to treat many underserved patients who died of metastatic cancer, he also pioneered cancer control by starting with a fundamental issue, "what i really needed to know was: why do people come in too late for treatment; what are the reasons?" to probe for the answers, dr. freeman employed an innovative public health lens. in , he published a landmark report addressing the impact of income and poverty on cancer entitled "cancer in the economically disadvantaged." this report urged the country to view cancer outcomes not just through a clinical viewpoint but also through the broader perspective of poverty. subsequent analyses have underscored his wisdom. for example, we now understand that in the united states, overall cancer survival decreases with increasing poverty level. for example, women in more affluent census tracts have a % overall -year cancer-specific survival rate, as opposed to % for those in less affluent census tracts; the same trends apply to males. , other data indicate that those with private insurance have better long-term survival than those with medicaid (or who are uninsured) and that use of screening varies inversely by socioeconomic position. these findings, among others, led to landmark institute of medicine reports such as unequal treatment: confronting racial and ethnic disparities in healthcare. dr. freeman fully grasped what nobel prize winner amartya sen would further explain, ie, that poverty impedes capability to choose one's own functioning in areas such as literacy, security, freedom of religion and expression-in short, the ability to live in a secure environment without discrimination and oppression. dr. freeman not only offered fresh insights into viewing these challenges but also offered innovative ways to address them. he transcended the confines of clinical medicine to envision new areas for advancement in public health. a major contribution was pioneering the "patient navigator program" that was first created at harlem hospital. such programs, now commonplace across the country, are designed to help every individual, regardless of culture, language, or country of origin, receive the efficient, optimal, and compassionate care they deserve. perhaps most noteworthy of all, however, has been harold's steady and gentle leadership style. a man of quiet passion, he led many initiatives with a dignified sense of service. his style of communication and decision-making always sets standards for professionalism, fairness, and humility. along the way, he has engendered fierce loyalty from everyone he met. dr. freeman represents a model of public health leadership worthy of our attention and respect. in the following sections, i explore both some of the special challenges and notable dimensions for leadership in public health. public health leaders must begin by acknowledging the extraordinary challenges of the discipline, not the least of which is the field's enormity of scope and goals. as opposed to clinical medicine, where health is generally regarded as a matter of one-on-one interaction between provider and patient, public health strives for the most lofty of aspirations, ie, "fulfilling society's interest in assuring conditions in which people can be healthy" , -or, as some have termed it, "saving of lives millions at a time". , , reaching such expansive goals requires attention to an extraordinary range of areas, as outlined domestically in the healthy people (hp) objectives or globally in the millennium development goals (mdg). they include the hp leading health indicators (physical activity, overweight and obesity, tobacco use, substance abuse, responsible sexual behavior, mental health, injury and violence, environmental quality, immunization, and access to health care), as well as specific mdg areas (eg, reducing infant and child mortality, combating major communicable diseases, and eradicating extreme poverty and hunger). , public health leadership also requires sophisticated understanding of the many dimensions which comprise the field. these include ( ) a philosophy of social justice that raises provocative ethical questions about the distribution of resources; ( ) a need to ground decisions in research when definitive data are often scarce; ( ) a delicate link with government that may provoke tensions when public health interventions potentially limit personal rights on behalf of community needs; and ( ) an orientation toward long-term prevention. perhaps the greatest challenge of the field, however, lies in its nonhierarchical structure involving seemingly limitless numbers of stakeholders. the field encompasses a growing multiplicity of actors, representing a dizzying array of values and perspectives about ends, means, and responsibility. today, a "typical" public health meeting may feature doctors, nurses, occupational therapists, social workers, government officials, business leaders, advocates, payers, providers, researchers, media experts, sanitarians, and, of course, concerned members of the lay public. after / , such meetings are also more likely to include police, fire, and emergency medical services personnel. this diversity of perspectives and values creates, on one hand, a rich, uncommon culture that links professionals from diverse backgrounds but also, on the other hand, a frequent "collision of worlds" concerning ends and means. moreover, with its egalitarian and social justice roots, the field is much less hierarchical than sectors such as business and the military that have previously generated many traditional leadership paradigms. however, innovative successes can bloom when public health leaders galvanize people in coalitions that rally around a results-centered focus. , strategic capacity blossoms with teams featuring heterogeneous perspectives, broadening group identity while building upon the contributions of all the individuals involved. [ ] [ ] [ ] in short, public health leadership starts with a foundation of science but ultimately requires social strategy, political will, and interpersonal skill. public health leaders assume the responsibility of navigating jarring juxtapositions among a diverse group of "ps": ( ) policymakers, ( ) penurious budget officials, ( ) the press, ( ) passionate advocates, ( ) purchasers (public and private), ( ) providers, and, ( ) the public. the s relentlessly interdisciplinary nature of the public health challenges the leader to harness talents, advance the power of prevention, and deliver new hope to areas where previously there was no hope. , defining and identifying appropriate frameworks for public health leadership can be an elusive task. to begin, although no consensus definition of leadership exists, the literature is filled with interesting proposals. president harry truman once offered, "a great leader is [one] who has the ability to get other people to do what they don't want to do and like it." benjamin zander, the british conductor, has said, "the job of the leader is to speak to the possibility." walter lippman has commented that "the final test of a leader is that he leaves behind in others the conviction and will to carry on." authors kouzes and posner define leadership as the "art of mobilizing others to want to struggle for shared aspirations." and of note, depree has observed, "the first responsibility of a leader is to define reality. the last is to say 'thank you.' in between, the leader is a servant." in addressing these definitions, the literature also abounds with a panoply of leadership theories, models, and frameworks. although all of them are static representations of dynamic processes, many have potential relevance to public health. of these, the concept of transcendent leadership has gained recent attention. in this perspective, crossan and others argue that leadership studies have, to date, focused disproportionately on transforming others and organizations when instead the larger emphasis should primarily rest on leadership of self. , doing so, in turn, fully enables leadership across the overlapping levels of self, others, and organizations. transcendent leadership involves going within, between, above, and beyond these levels. , as opposed to other classical leadership models that focus on followers, transcendent leadership theory shines special attention on self-awareness to understand one's own weaknesses and biases, and self-regulation to align values, intentions, and actions. , such attention may be particularly relevant in today's environment where strong distrust of authorities in leadership positions spurs added attention to issues of honesty, integrity, morality, transparency of goals, and consistency of words and actions. moreover, these themes concern more than the collaborative egalitarian world of public health to include a growing number of other arenas in the st century, because, as author thomas friedman has observed, "everywhere you turn, hierarchies are being challenged from below or transforming themselves from topdown structures into more horizontal and collaborative ones." moreover, it has been stressed that leadership is a choice and that one can lead at any age at any place, not solely in positions of authority or as heads of organizations. transcendent leadership therefore has an emphasis on wholeness, involving associates and constituents in collective decision making and group consent processes to serve the will of the group. , such leadership understands that ". . . we are all connected. if this could be taught and if people could understand it, we would have a different consciousness." we can apply these dimensions of transcendent leadership to the global public health goal of "the enjoyment of the highest attainable standard of health" for all human beings. dr. freeman's story exemplifies a number of themes in public health leadership: pinpointing passion and compassion; promoting servant leadership; acknowledging the unfamiliar, the ambiguous, and the paradoxical; communicating succinctly to reframe; and understanding the "public" part of public health leadership. by working between and above the levels of leadership of self, others, and organizations, transcendent leaders can ultimately shift the paradigm from "no hope" to "new hope" and create a renewed sense of community. standing for something "so you don't fall for anything" begins the journey of public health leadership. in fact, the most successful examples of public health leadership are fundamentally rooted in pinpointing passions , discovered from a leader's profound journey into self. the mission of preventing human suffering involves a deep understanding of one's values and spirituality, defined by reverend william sloane coffin as "living the ordinary life extraordinarily well." in addition, however, embracing a broader purpose requires not only the ability to suffer-passion-but also the ability to suffer with-compassion. father henri nouwen has noted, "compassion . . . asks us to go where it hurts, to enter into places of pain, to share in brokenness, fear, confusion, and anguish . . . compassion means going directly to those people and places where suffering is most acute and building a home there." certainly harold freeman's passion and compassion in the world of cancer control underscore nouwen's themes. often the best leaders are those who, after suffering greatly, have successfully transformed their pain into passion. indeed, so many leaders have endured and grown from indelible "crucible experiences," so named for the medieval vessel used by alchemists in attempts to turn base metals into gold. leadership expert warren bennis has written that such crucible experiences are intense, often traumatic, and always unplanned transformations that force deep reexaminations of values and assumptions. often though, the leader emerges stronger and more sure-imbued with a heightened sense of purpose. as hemingway has written "the world breaks everyone, and afterward, many are strong in the broken places." public health leaders, therefore, can gain passion and compassion through such crucible experiences. so, for example, until recently, the bylaws of mothers against drunk driving (madd) required that their presidents be those who were personally touched by the tragedy of the field. one recent president was launched into activism through the suffering of her family's separate drunk driving crashes. similarly, the late actor, christopher reeve, who played superman in action movies until a riding accident reduced him to quadriplegic status, used the remaining years of his life to advocate for stem cell research and the rights of the disabled. in his wheelchair, he had, perhaps, as much power and impact as when he was portraying a superhero on screen. all these leaders used their shared experiences to unite people and ultimately effect collective change. nouwen has written that such individuals are "wounded healers," whose pain motivates them to prevent suffering for others. he relates the talmud parable of a wounded healer who can be found "sitting among the poor covered with wounds. the others unbind all their wounds at the same time and then bind them up again. but he unbinds one at a time and binds it up again saying to himself, 'perhaps i shall be needed: if so i must always be ready.'" nouwen underscores the rich interconnections of pain, passion, and compassion by noting that "the great illusion of leadership is to think that man (and woman) can be led out of the desert by someone who has never been there." the journey into self also means constantly revisiting the fundamental, and often painful, question "who tells you who you are?" for too many, the answer lies outside in terms of titles, status, or external trappings. some even are defined by their enemies-that is, what they are against, as opposed to what they are for. in government and other hierarchical structures, many who are defined solely by their unquestioning loyalty to authority figures scramble for perceived power through proximity. but coffin reminds us that if power is a requirement for self-identity, then loss of power leads to loss of self. leaders may thus do better to focus on expressing, rather than proving themselvesnurturing the personal spirit and trusting the inner voice. such an approach helps one bear the inevitable slings and arrows of service and, in the words of gergen, "absorb the punishment without surrendering your soul." passion, although critical, is not enough. transcendent leaders humbly understand their own biases and that their driving passions can easily blind them to the passions of others. finding ways to connect passions and align their own spirit with that of others brings a leader closer to mobilizing people for a higher purpose. as has been written, that is the secret of the bond between spirit and spirit. as with any area in public health, no single leader has all the requisite skills and resources necessary to confront the constellation of complexities. for these and other reasons, public health leaders must engage in intergroup collaboration to serve the mission of the whole. in a stark contrast, then, to some classic leadership models portraying bold leaders directing passive followers, the public health culture favors a more collaborative, facilitative leadership that recognizes the value of complementary and synergistic leadership functions among multiple contributors. such servant leaders motivate and inspire individual and organizational commitment for change in a manner that is "insistent yet not domineering . . . credible rather than powerful . . . concerned with process as much as content." this public health approach also differs markedly from that of the traditional medical leader. classic surgical leaders in an operating room, for example, practice their craft in a hierarchical manner, possessing all the requisite technical expertise and skill to direct a team. in contrast, the transcendent public health leader is more like the symphony maestro, capable of playing perhaps only an instrument or two but required to coordinate and blend the melodies of dozens more. the maestro and the public health leader strive to strike the right balance and dynamics and in doing so may oscillate from being the focus of intense attention to being rendered almost invisible. focusing on the product and not the self, s/he is content to set the tempo and tone, confident that the music will soon flourish and flow. harold freeman lived by all these principles. he was surgeon and servant, combining service and leadership in his quest for a cancer-free world. in short, the most effective public health leader is unlikely to be the ceo with ready answers. rather "the servant leader" can "manage the dream" , by knitting disparate voices together and fostering change through open collaboration. in doing so, transcendent leaders shape organizations, while heeding harry truman's observation that, "[you] can accomplish anything in life, provided you do not mind who gets the credit." ideally, this transcendent leader will cultivate interdependence and oneness of mission, mobilizing individual commitment by inviting people in to build coalitions and share power. the traditional leadership trait of fierce independence gives way to a more valuable trait of fierce interdependence. such a leader first emphasizes creating that special interdependent team that can create synergy and ultimately results. author jim collins has written in his classic book from good to great, that good leaders often focus first on "who" and then on "what." as he noted, "good-to-great leaders first get the right people on the bus (and the wrong people off the bus) and then figure out where to drive it." learning to accept chaos-the unfamiliar, the ambiguous, and the paradoxical event-is essential for leadership in public health. ambiguity always accompanies this field characterized by partial knowledge, shifting dynamics and uncertain outcomes. rarely blessed with the luxury of rigorous academic studies with defined end points, public health leaders often find themselves intervening based on minimal or incomplete data. but intervene they must to begin the process of change. adding to the sense of chaos is the advent of an era where disasters have become the norm. today's public health leaders must be especially prepared to face the unfamiliar, including the fall anthrax attacks, the sars (severe acute respiratory syndrome), and hurricane katrina in . such unexpected crises can shake communities to the core, as ". . . one of the worst outcomes of a crisis is the collapse of fundamental assumptions about the world." these new challenges have prompted painful reexaminations of what had been taken for granted. for example, the anthrax attacks forced an awkward merger of public health, emergency management, law enforcement, and postal service investigators into a new post- / public health infrastructure. now, with the world nervously eyeing increases in human cases of h n influenza everywhere, the next pandemic has exposed major gaps in worldwide surveillance, disease control, resources (such as vaccines and antiviral medications), and an overall lack of a sound life-saving public health infrastructure. an artful leader in public health thus must live within this web of complexity, and sense potential creative opportunities and innovations as hidden issues surface and ripen to "raise one another to higher levels of morality and motivation." such leaders, although not necessarily seeking a specific outcome, acknowledge chaos as a useful starting point for change. as has been written, "chaos is not a mess, but rather a primal state of pure energy to which the person returns for every true new beginning." harvard leadership expert ronald heifetz has written about types of work; an ambiguous environment requires adaptive work. the first is technical work where the problem is clear and the solution requires involvement of an authority (eg, a patient's broken bone is set by a doctor). the second type of work is both technical and adaptive; the problem is clear, but the solutions require work shared by both the authority and the stakeholder (eg, a patient has heart disease, the doctor offers broad, lifestyle solutions to address the condition, and then the patient must change his way of life with respect to diet, exercise, cigarette dependence, or other areas). public health, however, usually finds itself wrestling with the third type of work, adaptive work, in which the problem definition requires learning, the solutions require learning, and the primary responsibility for the work lies more with the stakeholder than the authority. most of the major public health challenges facing our society fall in this third category. we look to authority figures for ready answers, when in fact, we need leaders without obvious, ready solutions who are, nevertheless, committed to embarking on the journey to define the problem and implement a solution. among the myriad public health challenges in today's world, such as creating health coverage systems for the uninsured, defining the appropriate parameters for genetic testing, eliminating homelessness, or preventing violence, leaders in authority face enormous pressure to ". . . offer more certainty and better promises." , in response, such authorities may be tempted to "sometimes fake the remedy or take action that avoids the issue by skirting it." , however, transcendent leadership in such instances may mean "giving the work back to the group." , for example, sustaining programs through public health budget cuts, a regular exercise in these uncertain times, is one example of leadership involving "disappointing people at a rate they can bear." managing expectations guides people committed to change to understand that it may not come overnight. in such circumstances, the effective leader may need to humbly acknowledge tolstoy's belief that "certain questions are put to human beings not so much that they should answer them but that they should spend a lifetime wrestling with them." all leadership requires the ability to communicate and persuade. for public health, the field's vast and hazy image necessitates succinct, concrete communication that can cut through the fog. communicating public health in conjunction with the mass media especially demands artful understanding of the different goals of the fields. the mass media generally aim to entertain or inform, whereas public health aims to promote social change. media usually address short-term personal concerns, whereas public health addresses long-term societal concerns. mass media gravitate to certain answers, whereas public health acknowledges uncertainty, realizing that conclusions can change. dr. freeman especially understood that communicating with the public often meant reframing to create new meanings. for example, he is credited with focusing attention on the critical disconnect between discovery and delivery. simply coining the phrase "the discovery to delivery disconnect" prompted renewed national attention on the challenges of cancer and its unequal burden on society. others have urged similar attention on reframing in the field of health disparities. the official definition of health disparities ("the quantity that separates a group from a specified reference point on a particular measure of health" ) can be viewed as dry and dispassionate. substituting instead the terms "inequalities" or "inequities" for disparities reframes the conversation closer to basic issues of unfairness-or even human rights-and in this way may thus capture the attention of an otherwise disinterested public. as noted communication expert lakoff notes, "frames are mental structures that shape the way we see the world. reframing is social change. reframing is changing the way the public sees the world. it is changing what counts as common sense." leaders master the power of reframing, using "steadfast concentration on the same core message along with the flexibility in how it is presented and openness to the message being apprehended at a number of levels of sophistication." by definition, both leadership and public health are public. hence public health leadership combines double doses of exposure and scrutiny. former college president nan keohane notes that, "the leader is always on duty, always on stage and anything she does is inescapably interpreted not as a private action, but as representing the organization itself." leadership expert warren bennis also warns of the trials and tribulations of being "on stage," noting, "you have to learn how to do the job in public, subjected to unsettling scrutiny of your every word and act; a situation that's profoundly unnerving . . . like it or not, as a new leader you are always on stage, and everything about you is fair game for comment, criticism, and interpretation (or misinterpretation). your dress, your spouse, your table manners, your diction, your wit, your friends, your children, your children's table manners-all will be inspected, dissected, and judged." such scrutiny can be especially intense in public health, where so many differing passionate factions clash under the watchful eye of the media. promoting change for many can represent costly loss for some. when, at the beginning of the hiv/aids epidemic in the s, former us surgeon general c. everett koop mailed what many considered to be sensitive information about risk factors and transmission to every house in america, the largest public health mailing in history, he was greeted with heavy criticism from many quarters. he withstood the assault, understanding that critics may "go after your character, your competence, or your family" in the hopes of leaving the leader marginalized or neutralized. in such times, leaders gain resolve from the words of david gergen who has commented, "the toughest steel goes through the hottest fire." when transcendent public health leaders make public what had been personal, they regularly assume risks. tobacco-company-executive-turned-whistleblower, jeffrey wigand, was fired after trying to change the system from within, going public to expose that the industry had long known that its products were addictive. along the way, he expressed regret for his time working for the industry. his story exemplifies that "real change comes from our willingness to own our vulnerability, confess our failures, and acknowledge that many of our stories do not have a happy ending." a transcendent leader can find a sense of oneness in juxtaposing a vision with the imperfect reality and living in the creative tension represented by the space between them. in some ways, the core of public health leadership hinges on surmounting the odds to kindle new hope for those being served. shifting the paradigm from "no hope" to "new hope" , in any setting may well be one of the most daunting human journeys of all. in these volatile times, many feel overwhelmed by the chaos of seemingly endless societal challenges. but "no hope" situations can give rise to underdog leaders, who successfully strategize, mobilize, transform, and rise above. such leaders fully recognize that "giant obstacles are brilliant opportunities-brilliantly disguised as giant obstacles." one example of this is the life of public health leader dr. jim o'connell who founded boston health care for the homeless in . in the decades since, jim has nurtured both an organization and movement that now cares for the most vulnerable in our society. as a street doctor, he not only has built an organization that now boasts over employees, but has also set a national standard for medical care for the homeless who routinely live on grates, under bridges, near racetracks, and propped up against public buildings. his transcendent leadership style is marked by service, humility, gentle passion, and compassion. other effective public health leaders also learn to relish, not reject, the role of the underdog. many, almost by definition, enter the field for social justice reasons and welcome fighting for the underserved. such leaders often find themselves in david versus goliath situations to "afflict the comfortable and comfort the afflicted." , , by challenging a goliath publicly, they work to create a "crack in the armor" and expose a soft underbelly. a major public health example of this lies in the creation of the world health organization (who) framework convention on tobacco control (fctc). the fctc is the first and only international public health treaty, now ratified by countries that have joined forces to counter tobacco industry marketing worldwide. hundreds of public health leaders in these ratifying countries have brought new hope by challenging a tobacco industry whose products are projected to cause a billion deaths in the st century. such leaders reject the status quo, "entice through moral power" and demand change. healthy people states "the health of the individual is almost inseparable from the health of the larger community and that the health of every community . . . determines the overall health status of the nation." perhaps no theme more embodies transcendent leadership than the goal of creating a renewed sense of wholeness for self, others and organizations .the most enduring legacy of any public health leader springs from honoring and creating a renewed sense of community. on a practical level, public health leaders can unify people in coalitions and organizations to craft a new shared urgency of public purpose and compelling direction. , for example, advocacy groups and their leaders in areas such as cancer, cardiovascular disease, substance abuse, and s hiv/aids can galvanize a new sense of collective purpose through new coalitions with shared commitment. in these circumstances, it is essential to have leaders who begin with a sense of urgency, create a guiding coalition, develop a vision and strategy, communicate the change vision, empower broad-based action, generate short-term wins, consolidate gains and produce more change, and anchor new approaches in the culture. definitions differ of what represents community. for some, the community is represented by a coalition. for others, it is a group of professionals or committed volunteers focused on a particular disease area (cancer, heart disease, women's health, or hiv, for example). for still others, a community may be one's neighborhood, city, town, state, country, or even the globe. for harold freeman, the community included anyone who cared about preventing human suffering from cancer. because these are times of declining social capital where people are often "bowling alone," leaders can bring new meaning to many global communities for the future. the modern public health model for leadership will unlikely be the omniscient figure with easy answers. rather the public health leader of the future may well be the transcendent, collaborative "servant leader" , who knits and aligns disparate voices together behind a common mission. they pinpoint passion and compassion, promote servant leadership, acknowledge the unfamiliar, the ambiguous, and the paradoxical, communicate succinctly to reframe, and understand the "public" part of public health leadership. by working between and above the levels of leadership of self, others and organizations, these transcendent leaders can ultimately shift the paradigm from "no hope" to "new hope" and create a renewed sense of community. such leadership will be vital as the st century progresses. beginning the journey to new hope may start by motivating underdogs who nurture the spirit, discover a passion to serve, cultivate interdependence, and create uncommon bonds. these emerging leaders can tap into their unique talents, passion, and compassion to promote a mission of "the highest attainable standard of health" for all, in every community. working papers of the center for public leadership institute of medicine. who will keep the public healthy?: educating public health professionals for the st century committee for the study of the future of public health. the future of public health committee on assuring the health of the public in the st century. the future of the public's health in the st century human rights from a u.s. state health department perspective the mpower package war on poverty. new york magazine special report on cancer in the economically disadvantaged area deprivation and widening inequalities in us mortality, - cancer disparities by race/ethnicity and socioeconomic status unequal treatment: confronting racial and ethnic disparities in health care development as freedom national cancer institute patient 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doc_id: cord_uid: el d g brunei darussalam is a small equatorial country of , square kilometers that lies on the north-west coast of the island of borneo. an affluent nation, its economy is based mostly on oil and gas. brunei’s gdp per capita of us$ , places the country fifth highest on this index internationally (international monetary fund, ). the population of brunei is about , , with malays, who are muslims, forming the majority (just under % of the country’s people) (prime minister’s office, ). the annual population growth rate is just over . %; life expectancy is years (central intelligence agency, ). "diabetes: a brunei affliction," ; van eekelen, stokvis-brantsma, frolich, smelt, & stokvis, ) . obesity is alarmingly on the rise among children in brunei; % were classified as overweight or obese in (ishak, ) compared to . % in (ministry of health, , cited in tee, . weight disorders are also common, particularly among malays, people of middle age, and females (chong & abdullah, ) . the common occurrence of abandoned newborns as a result of teenage pregnancies is also an issue. at least cases were reported between and ("increase in abandoned babies," , and five cases in ("abandoned baby needs mother's milk," ) . the ministry of health asked parents and the public to partner with them to deal with this problem ("need public-parents partnership," ) . calls for introducing sex education as a separate subject into the education system ("teach sex education in school," ) have been made in order to address "the number of babies born out of wedlock to teenagers aged less than years" (rasidah, ) . brunei also recognizes the need to achieve the who standard in dental health (ottoman, ) . because intoxicants such as alcohol and drugs are haram (forbidden) to muslims, their sale and public consumption is banned. however, compared to other asean (association of south east asian nations) countries, the rate of drug use in brunei is relatively high. brunei thus needs to focus on psychological and sociocultural settings to prevent drug abuse among its youth (united nations office on drugs and crime, ). islamic-based organizations play a key role in helping youth say "no to drugs" through motivational talks and workshops. the ban on smoking in public places, which came into effect on june , , is enforced through the tobacco act of and its regulations (razak & ong, ) . however, smoking is still prevalent, and is the major cause of cancer in brunei. to promote good health, education materials, posters, and pamphlets on health topics are made available to all (ministry of health, ). a major initiative has been the national health care plan - , which aimed to increase public awareness of non-communicable diseases. strategies focused on supporting people to embrace a healthier lifestyle through community participation and inter-sectorial collaboration directed at seven priority areas: nutrition, food safety, tobacco control, mental health, physical activity, health environments/settings, and women's health. these priorities were promoted through special events, publicity about major health issues, and appropriate measures for modifying lifestyles (who, ) . an example of these health promotion initiatives is a program that teaches healthy lifestyles to selected people with a body mass index of over . the three-month program consists of group sessions for physical activities, such as walking, hiking, trekking, and obstacle games. the program offers presentations and discussions on healthy diet, motivation, stress management, time management, and a range of physical exercises. it also involves fostering a commitment to physical activities, advice on how to prevent relapses, and ways of overcoming barriers to participation in physical activities. it furthermore includes shopping trips directed at identifying and buying healthy food. individual consultations with a psychologist, dietician, and physiotherapist are followed up every six months. however, success rates, as defined by a weight loss of five percent, have been low-at between . % and . % ( / data) . world diabetes days (ishak, ) are observed through charity walkathons, healthy mukim (village) programs, free health examinations, exhibitions, and distribution of posters to schools. a national diabetes plan, involving parents, teachers, and other community leaders as well as healthcare providers, is currently in the planning stage. its aim is to educate people about how to prevent diabetes and its complications ("diabetes: a brunei affliction," ). drug, alcohol, and smoking education is conducted via public talks, open dialogues, exhibitions, information in pamphlets, sports activities, mass urine screening, and anti-drug campaigns. interventions such as the "demand reduction strategy," anti-drug badge project, trade fairs, and counseling sessions are also in place. efforts to counteract smoking include education programs on the hazards of smoking that encompass road shows, health talks, exhibitions, and smoking cessation clinics (wilson, ) . between and , much attention was given to providing sports facilities in schools and increasing human resources for physical education. about . % of total expenditure for the ministry of education building improvement of school and infrastructure program was allocated to providing and upgrading sports facilities in government schools (undp, ) . the school curriculum is implemented in a didactic manner and is taught according to prescribed syllabi; students rely on drill and memorization to pass examinations that enable them to move to the next grade level. much health education in the school system and in the community focuses on knowledge dissemination instead of changing behavior. although the school curriculum has been revamped in recent years (ministry of education, ), much of the content in terms of health education remains the same as it was years ago. positive change, however, has included integrating within the curriculum core values and attitudes relevant to health education, such as self-confidence, self-esteem, selfreliance, and independence, along with caring, concern, and sensitivity. health and physical education has been allocated as a separate area of study, and emphasis on school-based assessment may allow for greater innovation in health education. descriptions of two relatively recent innovative programs initiated in brunei with direct or indirect implications for health education follow. the first program, an interdisciplinary one called english and physical education for health education, was trialed in a secondary school. strategies focused on integrating healthy concepts into english-language learning and providing students with opportunities to increase their physical activity. students' health concerns, such as nutrition, sexuality, and physical activities, were investigated. on healthy food days, students contributed money so that teachers could provide healthy food. discussions were held as to why the teachers chose certain foods and how students could establish healthy eating habits. students also examined their school lunch-boxes to identify the categories of food they contained. students' correspondence with pen-friends in australia contributed to building up their self-esteem in general. extracurricular activities promoted physical activities, with students contributing to the running of these activities (williams, ) . the second initiative saw university students engaged in community problemsolving projects, some of which involved local health-related concerns. three of these serve as examples. concerns related to disposal of cooking oil led students to discover that restaurants were disposing of some of their waste cooking oil by giving it free to food vendors. their actions were creating health problems for the community (ibrahim, hassim, lamit, & rangga, ) . the students produced pamphlets for the public that addressed how to cook without oil, the harmful effects of cooking with waste cooking oil, and proper ways of disposing of waste cooking oil, which included recycling it for diesel-engine fuel or soap-making. during the second project, students endeavored to make the community aware that the common use of polystyrene food containers meant that styrene was leaching into hot and oily food (abdul rahman, eu, muhammad kincho, & muhamad, ) . the students let vendors know why they needed to change containers, and they suggested alternatives, such as reusable steel containers. the third project focused on the use of cars as the main means of transporting children to and from school (zakaria, wahab, ismail, & abdullah bayoh, ) . the university students proposed to schools that they needed to encourage parents to let students use healthier transport options, such as walking, taking the school or public bus, and cycling. health education programs designed to overcome preventable diseases and solve present and future health problems need to be implemented in such a way that they can bring about positive changes not only in attitudes and beliefs but also in behavior. the national center for chronic disease prevention and health promotion (division of adolescent and school health, ) considers curricula that overemphasize teaching scientific facts about health matters in order to increase student knowledge of them are relatively ineffective. health education curricula should accordingly be based on sound research evidence and emphasize the teaching of essential health-related concepts. personal values that support healthy behaviors also need to be emphasized, as does shaping group norms that value healthy lifestyles and helping students develop the skills necessary to adopt, practice, and maintain health-enhancing behaviors. the essential challenge for brunei is to bring into play a full commitment to a health education policy that enables education institutions and health-promotion agencies to develop and implement new and innovative ways of markedly improving the health of bruneians. although some efforts commensurate with this aim have been taken, they are neither widespread nor publicized. innovative health education programs must be underpinned with modes of assessment that allow practitioners and educators to determine the extent to which people have the skills and ability to identify and work toward alleviating their health problems. assessment and development of affective factors that are important drivers of healthy lifestyles, such as caring for others and valuing oneself, is an important accompanying aspect of such programs. the next sections of this chapter focus on four types of program that contain these components and so should help secure a healthier brunei. in order to tackle its obesity problems, brueni could implement long-term life skills programs, such as the kitchen garden program (brock & johnson, ) and the school lunch initiative (rauzon, wang, studer, & crawford, ) . these types of program also promote the eating of vegetables and fruits. life skills programs furthermore involve campaigns directed at preventing teenage pregnancies. youth are taught skills such as assertiveness and negotiation and are encouraged to engage in open discussion and communication with one another, teachers, and health professionals about specific sexual practices (smith, kippax, aggleton, & tyrer, ) . an example of a successful such program is abstinence only. its content includes information and discussion on parenthood, dating, sexual refusal skills, and remaining true to oneself (mcguire, walsh, & lecroy, ) . another useful program, described by henderson ( ) , uses inquiry-based approaches that enable students to develop links between values and decisionmaking skills and from there make informed choices about their health, wellbeing, and general resilience. health literacy is not just about transmitting information, distributing pamphlets, putting up posters, and making appointments to see health professionals (nutbeam, ) . it is also, and more importantly, about taking action on the social, political, and economic determinants of health. in practice, this means teaching students the critical components of health literacy, such that they understand the determinants of health and have the skills to take remedial action when necessary. however, little, if any recognition, has been given to this type of teaching in brunei's schools, and this lack appears to be one of the main impediments to bringing about the type of curriculum change necessary to accomplish a critical level of health literacy. also, as gould, mogford, and devoght ( ) remind us, health educationalists and professionals themselves need to be educated. a particularly needed emphasis within the health curriculum is that of action learning. this type of learning helps empower young people to live healthily and to promote healthy living conditions (national institute of child health greece, ). the three examples of community problem-solving projects by brunei university students described above provide just one possible action-competence approach that brunei could adopt in this regard. experience in denmark (jensen, ) shows the success of such initiatives. brunei has adopted, as its guiding national philosophy, melayu islam beraja, or mib (malay islamic monarchy). education strategies are guided by the culture and traditions inherent in this philosophy (charleston, ) . much of brunei's educational provision emphasizes cognitive outcomes rather than affective and competency-based ones. for example, a study funded by the joint united nations programme on hiv/aids found that education systems in some countries, including brunei, employ hiv/aids-related education that is largely informationbound. sex education is conducted in a mechanistic way, focusing mainly on human reproduction and anatomy (smith et al., ) . the study also found that when education programs cater to the cultural sensitivities of the majority of the population, the effectiveness of those programs can be compromised because they do not address certain health issues, often because of inherent gender bias. from her study of bruneian health textbooks, elgar ( ) found that the gender bias evident in them meant concealment of issues affecting women's health. hinyard and kreuter ( ) suggest that because oral story-telling plays a significant role in malay culture, it could be used to promote positive health behavior. cheong and thong ( ) have done just this with respect to promoting pro-environmental attitudes in brunei. also, because muslims in brunei adhere strictly to the teachings of the quran, passages from it could be used to promote healthy lifestyles, such as this one: o children of adam! wear your beautiful apparel at every time and place of prayer: eat and drink: but waste not by excess, for allah loveth not the wasters. (al-a'r f: ) ('al , ) reference could also be made to passages in hadith, which records the traditions or sayings of the prophet muhammad. an example is this excerpt, which refers to eating and drinking in moderation. the prophet (peace and blessings be upon him) said: no human ever filled a container more evil than his belly. the few morsels needed to support his being shall suffice the son of adam. but if there is no recourse then one third for his food, one third for his drink and one third for his breath. (narrated by turmudzi, ibnu majah, dan muslim) ("eating and drinking," ) reference could also be made to religious edicts published for use in education. those relating to use of medicines (kasule, ) and models for eating set out in the quran (muhammad as-sayyid, ) are just two examples. although giving out leaflets on health matters is thought to be effective in some countries (see, for example, murphy & smith, ) , research conducted by paul, redman, and sanson-fisher ( ) suggests that even pamphlets that are well designed and include adequate content may not be an effective means of relaying information and changing behavior. better ways of communicating information are needed. information and communication technologies (ict) have the potential to deliver, at low cost, programs aimed at changing people's health-related behaviors. they are particularly likely to appeal to students from the "digital generation." ferney and marshall ( ) identify the utility of websites that include simple interactive features, such as online community noticeboards, personalized progress charts, email access to expert advice, and access to information on specific local physical activity facilities and services. the online social networks that have become particularly popular amongst young people in recent years could provide an especially valuable means of imparting health education. conclusion if brunei is to achieve its aspiration of bringing about a high quality of life for all of its people, much greater effort than that currently being exercised is needed, especially with respect to people's health. better health education within both schools and the wider community is a key to realizing this aim. there is a need to change behaviors and convert problems to solutions instead of just focusing on improving knowledge and attitudes. there is also a need to implement in health education programs attitudes and practices learned from research, especially those that take a holistic approach to health and health education. adopting an interdisciplinary approach to education and health and empowering the young to act in ways that exemplify healthy living are essential. psychosocial determinants of health behavior also need to be incorporated in schools' health curriculums and assessment practices. these determinants, which are grounded in the belief that each of us can exercise the control needed to change and improve our health-related habits for the better, encompass motivation, the perseverance needed to succeed, ability to recover from setbacks and relapses, and ability to maintain changed habits (armitage & conner, ) . health changes can only be effective if supported by social systems (bandura, ) , which include infrastructural, personnel, and policy aspects. for example, involving health education personnel in making health reports has proved effective in promoting healthy lifestyle practices (kwong & seruji, ) . providing safe facilities for walking and cycling and encouraging use of public transport are also part of this process (brownson et al., ; pucher & dijkstra, ; saelens, sallis, black, & chen, ) . brunei takes pride in the many jungle walking trails available to its residents. however, many of these trails need to be better mapped and made more accessible if the public is to continue using them safely. in essence, a healthier brunei is reliant on inter-sectorial partnerships within and across government as well as non-government agencies-partnerships that are committed to the same goals and the same means of achieving them. abandoned baby needs mother's milk to survive waste cooking oil in brunei the holy qur' n: text, translation, and commentary social cognition models and health behavior: a structured review health promotion by social cognitive means. health education behavior, , . brunei economic development board final report to the stephanie alexander kitchen garden foundation the% program/pdf/kgevaluation_key_findings.pdf promoting physical activity in rural communities: walking trail access, use, and effects the world factbook: life expectancy at birth implementing a developmental perspective of learning in the first year of school: brunei darussalam. paper presented to the australian association for research in education conference story-telling in science teaching health of our patients based on body mass index a glimpse of diabetes mellitus in brunei darussalam diabetes: a brunei affliction characteristics of an effective health education curriculum science textbooks for lower secondary schools in brunei: issues of gender equity website physical activity interventions: preferences of potential users successes and challenges of teaching the social determinants of health in secondary schools: case examples in values, wellness and the social sciences curriculum. international research handbook on values education and student wellbeing using narrative communication as a tool for health behavior change: a conceptual, theoretical, and empirical overview waste cooking oil in brunei international monetary fund (imf). ( ) obese youth in brunei at risk. borneo bulletin environmental and health education reviewed from an action oriented perspective: a case from denmark patterns and trends of religious edicts (fatwa mufti kerajaan & irsyad hukum) on medical matters in brunei darussalam a report on the healthy lifestyle initiative at brunei shell petroleum company sdn bhd content analyses of little v abstinence-only education programs: links between program topics and participant responses health promotions: health topics brunei may have a new hospital pola makan rasululah: makanan sehat berkualitas menurut al-quran dan as-sunnah crutches, confetti or useful tools? professionals' views on and use of health education leaflets health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the st century dental health not up to standard print material content and design: is it relevant to effectiveness? bandar seri begawan: department of economic planning and development, prime minister's office promoting safe walking and cycling to improve public health: lessons from the netherlands and germany concern over teen abortions in sultanate. brunei times students' knowledge, attitudes, and behavior in relation to food: an evaluation of the school lunch initiative brunei joins fight against smoking. brunei times neighborhood-based differences in physical activity: an environment scale evaluation hiv/aids school-based education in selected obesity in asia: prevalence and issues in assessment methodologies united nations development program (undp) commonwealth youth program, government of brunei and unodc collaborate to fight drug abuse in brunei prevalence of glucose intolerance among malays in brunei three soccer balls, two netballs and no health education: can healthy outcomes be achieved? a case study of one teacher's efforts to promote healthy lifestyles in a se asian high school smoking top cause of cancer deaths in brunei brunei darussalam environmental health country profile world health organization (who). ( a). world health organization regional office for the western pacific health situation and trends: communicable and noncommunicable diseases, health risk factors and transition the author wishes to thank the following for assisting with the preparation of this chapter: peck-yoke oh for her assistance in proof reading this chapter, officers from the health promotion centre of the ministry of health and the health education unit of the ministry of education for sharing information, views and experience on health education in brunei, and dr hj gamal abd nasir hj zakaria and dr hjh salwa d. hj mahalle for their advice on references to the quran and hadith. key: cord- -as o nt authors: osterholm, michael t. title: global health security—an unfinished journey date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: as o nt this supplement is a timely, comprehensive compendium of the critical work being done by the centers for disease control and prevention and various partners to enhance and expand the global health security agenda. this perspective provides a review of, and comments regarding, our past, current, and future challenges in supporting the global health security agenda. w e have witnessed numerous global public health achievements over the past century, resulting in major gains in life expectancy. these achievements resulted primarily from our unprecedented ability to prevent and control infectious diseases. because of technological advances, such as electricity, we were able to provide safe water and sewage systems ( ) . we manufactured vaccines and antimicrobial drugs and, in some situations, stored and distributed them via reliable cold chains around the world. we began to refrigerate our pathogen-vulnerable food. pasteurization of milk supplies became commonplace. smallpox eradication, the near elimination of aedes aegypti mosquitoes from the americas, and major gains against killer childhood vaccine-preventable diseases led some to proclaim in the s that we had beaten infectious diseases. however, as we entered the s, any sense of celebration ended as the hiv/aids pandemic took hold and outbreaks of emerging pathogens were increasingly recognized. key victories began to fade as the growing number of failed states around the world made basic public health activities like vaccination extremely difficult and sometimes dangerous. furthermore, the more than quadrupling of the human population since , especially skyrocketing growth in megacities of the developing world, and the unprecedented level of global trade and travel ( . billion international air passengers in ) have ensured that emerging microbial pathogens could navigate the globe quickly. finally, growing awareness of the looming threat of antimicrobial drug resistance has changed our view about being able to successfully manage and treat many life-threatening infections. the outbreak of severe acute respiratory syndrome in was a wake-up call to the global public health community that it lacked an international vehicle for rapidly detecting and responding to a multicountry outbreak, particularly one caused by a respiratory-transmitted agent. despite the world health organization's (who's) adoption of the international health regulations to address this concern, the pandemic of influenza a(h n ) was a "live fire demonstration" that the world was still ill-prepared for global public health emergencies. subsequent emerging microbial threats, including cholera in haiti ( ) what has changed to make the world a safer place against infectious diseases, given the cumulative lessons learned from severe acute respiratory syndrome, influenza a(h n ), ebola, and other emerging threats? the global health security agenda (ghsa) was launched by countries, who, the food and agriculture organization of the united nations, and the world organisation for animal health in february , just as the ebola outbreak was unfolding ( ) . ghsa is now a growing partnership of more than nations and organizations designed to help build countries' capacity to elevate global health security. ghsa pursues a multisectoral approach to strengthen global and national capacity to prevent, detect, and respond to human and animal infectious disease threats, whether occurring naturally or accidentally or deliberately spread. the centers for disease control and prevention (cdc) supports staff in countries. in , cdc supported work in countries conducting broad-based capacity-building efforts to help ensure global health security. it is critical to consider that although cdc's mission is to protect americans, we cannot ensure domestic preparedness without ensuring that global infectious disease threats are contained at the source before they reach the united states. the number of countries that are currently strengthened through these cdc health security programs is, however, dependent on intermittent us government funding. moreover, the -time, -year emergency congressional funding in to end the west africa ebola epidemic and implement ghsa in us-supported countries ends in . this supplement of emerging infectious diseases is a timely, comprehensive compendium of the critical work being done by cdc and various partners to enhance and expand global health security. the article by tappero and colleagues ( ) presents an overview drawing from several articles in this issue and also provides an excellent historical summary of cdc's invaluable contributions to global health security. this supplement contains articles on ghsa progress, the joint external evaluation process, the recent west africa ebola outbreak, and building capabilities in disease surveillance, workforce, emergency response and preparedness, laboratory partnerships, and national public health institutes. one of cdc's finest hours in its entire -year history was its response to the west africa ebola outbreak. many international organizations responded to the outbreak, including who and key nongovernmental organizations, but cdc's effort, with > , staff deployments, was consequential to bringing the epidemic under control and preventing the emergence of a major outbreak in nigeria. who is the international lead agency for global outbreak response, but cdc's technical expertise, epidemiologic and laboratory workforce development training, and disease detection programs are cornerstones for ministry of health and who health security activities globally. will ghsa and who's and cdc's efforts help create a world safer from infectious disease threats and elevate global health security as a priority? can the international public health community effectively prevent, detect, and respond to human and animal infectious disease threats? these programs help advance the global agenda for infectious disease prevention and control, but we still need to garner greater political will for additional progress. recently, in our book deadliest enemy: our war against killer germs ( ), mark olshaker and i detailed a -point crisis agenda if the world is to minimize, if not eliminate, the risk of catastrophic pandemics, outbreaks of critical regional importance, and intentional use of biologic weapons, including genetically altered pathogens. at the top of our crisis agenda are frightening scenarios: the rapidly emerging consequences of a like influenza pandemic and the slow-moving tsunami of antimicrobial drug resistance. outbreaks of critical regional importance include diseases such as ebola, lassa fever, nipah, mers, and mosquito-borne diseases like zika. finally, the prospect for the intentional use of biologic agents cannot be understated. this scenario is often seen through the lens of the cases of anthrax, including deaths, that occurred on the heels of the september , , attacks in the united states. this limited number of cases does not portend the public health crisis this attack triggered and the extensive public health resources required to respond to it. a future, much larger bioterrorism attack with a highly lethal agent, such as drugresistant bacillus anthracis, variola virus, or some other genetically altered pathogen, is not only possible but also highly likely. for true global health security, governments and philanthropic organizations must support manhattan project-like initiatives in research, development, manufacturing, and distribution of game-changing vaccines for high-priority pathogens. the new coalition for epidemic preparedness innovations is a good start, but we need to greatly expand these and related efforts to quickly address the types of objectives outlined in our crisis agenda. for example, we need a similar initiative for developing new antimicrobial drugs and alternative therapies, like phage treatment, for antimicrobial drug-resistant infections. point-of-care diagnostics to enhance early appropriate antimicrobial therapy are also urgently needed. all countries need to have the laboratory, trained workforce, surveillance, and emergency operations capabilities to prevent, detect, and respond to disease threats. only when these accomplishments are realized can we truly be on the road to global health security for infectious diseases. until then, the goal of global health security remains an unfinished journey. brainyquotes: winston churchill quotes deadliest enemy: our war against killer germs report of the ebola interim assessment panel commission on a global health risk framework for the future. the neglected dimension of global security: a framework to counter infectious disease crises global health security: the wider lessons from the west african ebola virus disease epidemic us centers for disease control and prevention and its partners' contributions to global health security key: cord- -q peybon authors: pongcharoensuk, petcharat; adisasmito, wiku; sat, le minh; silkavute, pornpit; muchlisoh, lilis; cong hoat, pham; coker, richard title: avian and pandemic human influenza policy in south-east asia: the interface between economic and public health imperatives date: - - journal: health policy plan doi: . /heapol/czr sha: doc_id: cord_uid: q peybon the aim of this study was to analyse the contemporary policies regarding avian and human pandemic influenza control in three south-east asia countries: thailand, indonesia and vietnam. an analysis of poultry vaccination policy was used to explore the broader policy of influenza a h n control in the region. the policy of antiviral stockpiling with oseltamivir, a scarce regional resource, was used to explore human pandemic influenza preparedness policy. several policy analysis theories were applied to analyse the debate on the use of vaccination for poultry and stockpiling of antiviral drugs in each country case study. we conducted a comparative analysis across emergent themes. the study found that whilst indonesia and vietnam introduced poultry vaccination programmes, thailand rejected this policy approach. by contrast, all three countries adopted similar strategic policies for antiviral stockpiling in preparation. in relation to highly pathogenic avian influenza, economic imperatives are of critical importance. whilst thailand's poultry industry is large and principally an export economy, vietnam's and indonesia's are for domestic consumption. the introduction of a poultry vaccination policy in thailand would have threatened its potential to trade and had a major impact on its economy. powerful domestic stakeholders in vietnam and indonesia, by contrast, were concerned less about international trade and more about maintaining a healthy domestic poultry population. evidence on vaccination was drawn upon differently depending upon strategic economic positioning either to support or oppose the policy. with influenza a h n endemic in some countries of the region, these policy differences raise questions around regional coherence of policies and the pursuit of an agreed overarching goal, be that eradication or mitigation. moreover, whilst economic imperatives have been critically important in guiding policy formulation in the agriculture sector, questions arise regarding whether agriculture sectoral policy is coherent with public health sectoral policy across the region. influenza virus a h n has been causing significant outbreaks of highly pathogenic avian influenza (hpai) in poultry since late . the challenge of hpai has been especially profound in south-east asia where it has become endemic in poultry in several countries (who a) . hpai is important for several reasons including its zoonotic potential. there have been confirmed human cases and deaths globally reported to the world health organization (who) as of september . of these, cases and deaths were reported from south-east asia; indonesia, vietnam and thailand have reported , and cases, respectively, and , and deaths, respectively ). thus, south-east asia has shouldered a substantial amount of the global human burden of hpai. control of hpai remains a global public health challenge because of concerns that viral change may result in a global pandemic. this concern was recognized by the international community. by , indonesia, vietnam and thailand had received commitments of substantial sums of aid, with us$ million, us$ million and us$ million being committed, respectively (un system influenza co-ordinator and world bank ). concerns regarding a potential pandemic arising as a result of the spread of h n persist despite the emergence of the pandemic (h n ) . indeed fears of re-assortment between h n and h n have the potential to further heighten concerns given the endemic nature of h n in south-east asia and the pandemicity of h n (belshe ) . as well as affecting human health, hpai has had an impact on poultry with flock mortality often above %, and culling of flocks as a control measure resulting in an economic burden felt by families and communities as well as impacting upon domestic and international trade. since , at least million poultry birds have died or been culled as a result of the h n epidemic in indonesia (ministry of agriculture ; foster ). the economic loss has been estimated at us$ million (komnas presentation ) . in thailand, more than million poultry have been killed, and the economic cost has been estimated to be at least us$ billion to the poultry industry alone (department of disease control ). in vietnam, since , million poultry have died or been culled, with . % of poultry culled in - (pfeiffer et al. ). the economic impact in was estimated to be us$ million due to loss of poultry, with additional costs of us$ million for the poultry vaccine programme. moreover, the government set aside a budget allocation of us$ million for the entire year for support for birds culled during outbreaks. over the past years, two interventions have received considerable attention from policy makers and received substantial policy attention and implementation funding: vaccination of poultry and antiviral stockpiling for humans. this paper is focuses on these two policies. in march , the world organization for animal health (oie), the food and agriculture organization (fao) and the instituto zooprofilatttico sperimentale delle venezie (izsve) issued recommendations to support the eradication of hpai, following a joint oie/fao/izsve conference in verona (oie ) . the verona recommendations acknowledged that the control of hpai was a complex issue and that new strategies were needed that complemented traditional approaches to eradicating the disease. they suggested that control strategies could be based on a combination of culling, movement restrictions and emergency vaccination. the purpose of poultry vaccination is primarily to reduce replication and viral shedding through the induction of protective immunity in poultry flocks. vaccination may also, it was suggested, prevent the introduction of avian influenza. the agencies recommended that countries consider introducing poultry vaccination given local epidemiological profile, a determination of costs and benefits to different stakeholders, and issues of operational feasibility amongst others. in , who issued guidelines on the management of a regional stockpile of the antiviral drug oseltamivir on the prediction that an influenza pandemic may result globally in more than billion cases and - million deaths (who b). the need for a regional stockpile of oseltamivir was predicated on its strategic use as an intervention to supplement national capacity to contain the emergence of a potential pandemic at its epicentre through the rapid deployment of the drug to halt transmission and contain disease. the guidance advocating national stockpiling of antiviral agents was aimed at securing capacity for mitigation purposes. in , it was estimated that stockpiles that cover - % of the population would be sufficient to treat most clinical cases and could lead to - % reductions in hospitalizations (gani et al. ) . poultry vaccination and antiviral stockpiling policies reflect interpretations of the evidence base, responses to international agencies' recommendations, and local political imperatives and competing public health priorities. three countries in south-east asia have responded to the challenge of hpai in different ways. whilst indonesia and vietnam introduced poultry vaccination programmes, thailand rejected this policy (but adopted other non-vaccine measures such as culling with compensation, and movement restrictions of poultry, for instance). by contrast, all three countries adopted similar policies for antiviral stockpiling in preparation for a global pandemic. this paper explores, through a comparative analysis of policy formulation, why different approaches were adopted in countries in one policy arena, whilst in another linked policy field, substantial similarities across all countries emerged. the conceptual framework for analysing two policies, poultry vaccination for hpai and antiviral stockpiling for pandemic influenza in three countries in south-east asia (indonesia, thailand and vietnam), was adapted from walt and gilson ( ) . our retrospective analysis focused principally on the policy formulation process of the two defined policies. policy content was determined through a review of policy documents. in the case of vaccination, though no explicit policy to vaccinate was introduced in thailand, there was an explicit policy not to do so (department of livestock development ). thus, though hardee et al. ( ) suggested that written policy documents should include a rationale, goals and objectives, programme measures, implementation arrangements, funding and other resources, and plans for monitoring and evaluation, we adopted a definition of policy based on official guidance on defined intervention, a purposive approach proposed by green and collins ( ) . our policy process analysis is focused on the formulation process in order to explore people and institutional relations, and how policies were arrived at or agreed upon and communicated (sabatier and jenkins-smith ) . we used multiple qualitative research methods (patton ): literature review of both primary and secondary documents, as well as in-depth interviews of key informants relevant to the policies. primary documentary policy data were collected through a review of official documents including laws and regulations, government strategic plans, guidelines, ministerial minutes of meetings and correspondence between ministries and other agencies, and briefing papers. secondary policy documentary data sources included case reports, business reports, academic documents, and newspaper and other media reports. for in-depth interviews, stakeholders were selected through purposive sampling and snowball sampling (hansen ) and included interviewees from ministries (health, agriculture, finance, and labour), policy makers at local and central levels, academics, public sector workers (doctors, veterinarians, public health specialists), non-governmental agencies, the private sector (representatives of the pharmaceutical industry and the poultry industry), united nations (un) agencies and donor agencies. triangulation was ensured through interviewing a wide range of respondents and cross referencing with documentary data sources. data were qualitatively analysed and key emerging themes were identified and consolidated in a framework that was checked and refined iteratively. over in-depth stakeholder interviews were conducted between march and november (table ) . informed consent was obtained from all interviewees. where anonymity was sought, this is respected. data analysis was undertaken simultaneously with data collection (glaser and strauss ) . the 'framework analysis' method was used to analyse the data. this consisted of familiarization, identifying a thematic framework, mapping and interpretation. a contact and content summary form was developed for each interview during familiarization (rashidian et al. ) . the initial thematic framework was developed using literature, prior thoughts developed during workshops, and interviews, research questions and a thematic guide (arredondo and orozco ) . the initial thematic guide was developed through a series of meetings amongst researchers. comparative analysis was conducted by comparing information gained from documentary review with information provided by interviewees (patton ) . the preliminary data analysis was supported by further analysis at completion of data collection. data were collected on cards and catalogued across categories and themes. figure shows a schematic framework of the policy analysis methods. relevant ethics committees in each country reviewed the study protocol and granted permission for the study. vaccine policy in each of the three countries differed over the period studied in terms of either formal or informal policies. table summarizes the key points in policy analysis leading to the poultry vaccination policy in the three countries. by contrast, all three countries developed antiviral stockpiling policies that were both similar and consistent with international recommendations. indonesia set a policy objective in to achieve population coverage for treatment of . - % of its population (ministry of health ; interview # in ) . similarly, thailand's policy of march aimed to provide treatment coverage for % of the population (ministry of public health ) . in both countries, because of budget constraints, the priority allocation is focused on rapid containment through treatment of people exposed to poultry and health care workers exposed to the first cluster of human cases in the event of a pandemic. a stepwise increase in stockpiling was envisaged in thailand, with year-on-year increases of treatment courses being secured for years (interviews # th , # th ). vietnam adopted an approach in april that mirrored indonesia's and thailand's, and by november , the administration of pharmaceutical management announced an agreement with hoffman la-roche to provide million capsules, which is sufficient for about . % of the population (ministry of health a). two key factors informed poultry vaccination policy in indonesia. the first was economic: the economic consequences of infected poultry, the impact on domestic and international trade, and the costs to poultry producers and indonesia's trade balance. the second factor was governance: indonesia's decentralized policy-making process and policy implementation fundamentally informed the process of policy development in relation to poultry vaccination. compared with thailand, the export poultry market for indonesia is small whilst the internal domestic market is relatively large. the policy of vaccination was driven, in large part, by recommendations from government advisory experts on drugs for animal use, experts on communicable diseases, the office for animal quarantine, the pharmaceutical industry and lobbyists from both large-and small-scale poultry producers serving predominantly domestic markets (interviews # in , # in ). large-scale poultry producers, through industry associations and high-level contacts with government, were especially powerful lobbyists and effective at influencing vaccine policy (interview # in ). small-scale producers, though having some influence through their industry associations, effectively influenced local media outputs, notably television and newsprint media. producers were especially concerned that, with high poultry death rates from h n and the consequences of culling decimating poultry flocks, their domestic markets would succumb to international producers wishing to exploit indonesia's demand for poultry products (interviews # in , # in ). one interviewee from the ministry of agriculture noted this and alluded to food security issues too (interview # in ): ''if we implemented a culling process, we might not have sufficient supplies of chickens. the disease has spread extensively. a culling policy will not be favourable politically.'' indeed, some large-scale producers had implemented vaccine use before the government formalized its position on poultry vaccination (interview # in ). thus, pressure to culling was also potentially very costly to the government. compensation to producers, if it was to be effective, had to be close to market values. 'stamping out' (culling all poultry in the areas of the outbreaks) was not implemented since this policy has implications for the government to provide compensation which the government cannot afford (interview # in ). in other words, vaccination was considered more affordable than financial compensation for culling. a further consideration for vaccination was the protection of the gene pool of indonesian poultry, something threatened if the majority local breeds were culled (interview # in ). eradication of hpai had been considered by policy makers but concerns that it was unfeasible, largely because of cost considerations, meant that greater weight was given to vaccine implementation (interview # in ). the government's promotion of vaccination was supported by the un agencies of the fao and the oie. the relationship between the fao, its office located within the ministry of agriculture, and the government was reported by several informants as being particularly close (interviews # in , # in , # in ). the fao advocated a risk assessment for pandemic influenza prior to implementing a vaccination policy. indonesia's limited vaccine implementation capacity was a cause of some concern because it would limit vaccination effectiveness, and also potentially pose a wider public health threat from persistent viral shedding. however, immediate domestic economic considerations within the animal health community weighed more heavily on policy makers' minds than human public health concerns of uncertain magnitude in an uncertain future. scientific evidence was also to support a poultry vaccination policy. research published in had shown that vaccination protected poultry from lethal infection with influenza a h n but virus shedding could persist (seo and webster ) . agencies concerned with human public health, notably the world health organization (who) and the ministry of health, were largely absent in the policy formulation process for poultry vaccination. however, one year after the policy was implemented, in , concerns were being aired in the human public health community because of human cases of influenza a h n occurring despite there being fewer poultry cases and even in areas where vaccination had been effectively implemented (suroso ) . the reason, it was suggested, that public health agencies were absent from the policy formulation process was the organizational silos that these agencies appeared to sit within, hindering cross-disciplinary and crossinstitutional communication. these institutional silos persisted despite the national committee on avian influenza including high-level representatives from several ministries, such as the coordinating minister for people's welfare (committee chairman), the coordinating minister for economic affairs, the minister of agriculture, the minister of health, and some other related ministers, commander of the indonesian army, chief of the indonesian police and the chairman of the indonesian red cross. because of the devolved nature of governance in indonesia, consistent and coherent policy implementation has become a major challenge (forster ). although the issue of vaccination had climbed up the policy agenda at central level, especially in the ministry of agriculture and the national committee on avian influenza preparedness, devolved decision-making, budgetary constraints and limited implementation capacity at district and regional agency levels meant an uneven implementation of policy across the country (kromo, n.d.). these geographic disparities have been compounded by limitations in monitoring and evaluation capacity. thus a formal policy of vaccination, driven by domestic economic concerns, has been only patchily implemented, constrained by economic, geographic, governance and infrastructural impediments. eradication of influenza a h n was deemed, it was both human and animal health input but more weight on animal health side. implied, not feasible and a policy of mitigation given the virus' endemic status has been adopted informally. vietnam's exposure to influenza a h n had resulted in substantial economic impact prior to . the poultry industry had been severely affected, with million poultry being culled in - (pfeiffer et al. ) , with an economic cost equivalent to a . percentage fall in gross domestic product (gdp) (dinh et al. ) . poultry production in vietnam is dominated by back-yard, small-scale producers. the export market is very small. these small-scale producers, along with community leaders, voiced their concerns about the culling response to influenza a h n through local newsprint and television media in a manner similar to that witnessed in indonesia. the principal concerns of producers were related to the economic hardships that resulted from diseased birds and culling, and the impact on poultry purchasing behaviour, because consumers were becoming wary of buying poultry, prices were falling and profit margins were declining (interview # in ). as in indonesia, the fao played an important role in offering guidance and support to policy formulation in vietnam. in , the fao recommended to the ministry of agriculture a unique policy of blanket vaccination based on the premise that disease would be controlled and virus shedding would be curtailed (fao ; vu ). vaccination policy in china, a major vaccine producer, where reports of successes from vaccinating ducks were being generated, helped persuade stakeholders in the department of animal health that an aggressive vaccination policy would be effective (interview # in ). these reports preceded fao advice and ensured policy makers were becoming receptive to the notion of an important policy shift (ministry of agriculture ), a shift that put vietnam in the spotlight in the international community. the proposal for blanket vaccination policy was, however, not universally accepted. some scientific expert advisers to the department of animal health were concerned on two counts (interview # in ). they were concerned, firstly, that safety issues (for poultry) had not been fully resolved, and secondly, that consumers' perception of the quality of poultry would be detrimentally affected and demand for domestically produced products would fall. these concerns were overridden by the scientific position taken by the majority of advisers and the international community (fao ) . unlike indonesia, stakeholders concerned with the human health consequences of influenza a h n , including high-level ministry of health personnel, were intimately involved in policy formulation and supportive of vaccinating poultry through ongoing policy dialogues between ministries as well as through their positions on the national steering committee for avian and human influenza control and prevention. no concerns were raised about the potential public health consequences of ongoing viral shedding or the masking of disease in poultry (something that, it has been suggested, might make it difficult to detect outbreaks early). the institutional silos that separated human public health from animal welfare and economic considerations that were apparent in indonesia were not present in vietnam. the centralized and robust nature of governance arrangements in vietnam ensured cross-ministerial communication (interview # vn ). substantial international financial support and powerful government advocacy ensured that implementation of policy was systematically and comprehensively applied, in contrast to indonesia. thus, the operational capacity, an element that the fao suggested was an important consideration in poultry vaccination policy, was high and, unlike in indonesia, has not threatened to undermine formal policy to date. thus, vietnam in contrast to indonesia, with the considerable support of the international community, embraced the notion of eradication of influenza a h n and deemed vaccination an important policy component if this goal was to be achieved. economic domestic considerations facilitated this strategy whilst human public health concerns received little attention. as with indonesia and vietnam, the principal issue influencing vaccination policy in thailand was the economic imperatives (safman ). public health assumed less importance, though stakeholders had greater voice than in indonesia and vietnam. thailand, however, unlike vietnam and to a lesser degree indonesia, has a very substantial export market as well as a large domestic market for poultry. thailand's poultry production is also, by contrast, dominated by industrial large-scale producers, who oppose poultry vaccination. on the other hand, vaccination supporters are predominantly rural people with backyard poultry production systems. backyard poultry are reared for family consumption rather than trade. that noted, backyard poultry including fighting cocks, though of little national economic importance, retain an important traditional position in the cultural life of the country, particularly in rural communities. the export economy played an important part in vaccination policy formulation. in , the year prior to the h n outbreaks, the value of chicken exports was approximately us$ billion, and it declined by almost half in the following year when major importers banned chicken from thailand during the outbreaks (department of disease control ). if influenza a h n was to become endemic in poultry in thailand, export markets would suffer and impact substantially on gdp. importers, especially from the european union and japan, the largest export markets for thailand, were concerned that vaccination would hinder detection of influenza a h n , and thus would ban imports of vaccinated chickens (manager online a; the nation ). international trade would be impacted severely, noted one member of the national advisory committee (interview # th ). industry lobbyists, working both behind the scenes and through the mass media, helped ensure that policy makers remained aware of the concerns of the export industry. for small-scale producers as well as the backyard producers, some visibility to owners of fighting cocks was given through the support of some well-known celebrities, who voiced their support for the vaccine through mass media. ' we are happy that we fight for the small producers and we accepted the government resolution, but we still believe in the effectiveness of vaccination', one prominent celebrity was quoted (manager online b). in contrast to indonesia and vietnam, the fao office in bangkok was less supportive of a vaccine policy. their concern was not that the vaccine per se could not be an effective tool in the control of influenza a h n but, if implementation was not robust and comprehensive, then the policy may generate public health problems from viral shedding. linked to this was uncertainty over when to stop vaccination and the development of a coherent exit strategy (interview # th ). the fao's concerns, though different from some poultry producers' concerns, were strategically allied in advocating non-vaccination. an opposing voice in this debate was that of small-scale producers and owners of fighting cocks. their interests were unrelated to international trade, but addressed the sustainment of long-held cultural traditions, traditions that were threatened by culling, as reflected by a supporter of backyard chicken production systems (interview # th ). they also supported the poultry vaccination policy because of its impact on other diseases such as newcastle, an opinion advanced, for example, by a fighting cock's owner (interview # th ). advocates of vaccination also highlighted scientific evidence used in support of the verona recommendations by oie ( ), and evidence that vaccination in mexico had helped reduce viral shedding (interview # th ). stakeholders whose principal interests were in protecting human public health broadly took a similar position on vaccination policy. the ministry of public health (moph) and ministry of agriculture and cooperatives held frequent formal meetings under the deputy prime minister's office. the concerns voiced by public health advisers and officials at the moph were similar to those voiced by indonesia's public health stakeholders, that the possibility of continued viral shedding, especially in the absence of disease in poultry, might pose a human public health threat and raise the potential for re-assortment into a more dangerous strain (interview # th ). however, unlike in indonesia, these voices were heard, acknowledged and were in harmony with ministries beyond public health, including those that had responsibility for agriculture, and the cabinet more broadly (interviews # th , # th ). other than small-scale producers, all others came to the same conclusion: that poultry vaccination was not the best policy response to the threat posed by avian influenza h n and that policy should emphasize non-vaccine measures. indonesia indonesia aligned its antiviral stockpiling policy with the who guidelines regarding a public health response through ensuring population coverage (who ) . given budgetary limitations, however, the policy was formulated to provide treatment for only . - % of the population. by , indonesia had procured million oseltamivir capsules, equivalent to population coverage for treatment of about . %. economic imperatives rather than public health research evidence was the dominant influencing factor in target setting for population coverage (interviews # in , # in ). stocks were supplied through central government purchases, from a japan-asean (association of southeast asia nations) collaboration, and through who (interviews # in , # in ; ministry of health ). the strategic objective of stockpiling of antivirals was explicitly rapid containment. as in other countries of south-east asia, in contrast to more affluent countries in europe and north america for example , a mitigation strategy that was dependent upon substantial population coverage with antiviral treatment courses was not considered feasible . following who's recommendation to reserve oseltamivir in the event of a pandemic, planning for importation, production and supply of the drug became a part of vietnam's national strategic plan. the ministry of health calculated that approximately % of the population was likely to fall sick in the event of a pandemic. vietnam's national preparedness plan in response to avian influenza epidemic h n and human influenza pandemic (government of vietnam a) in , the thai ministry of public health estimated that % of the population might succumb to the disease during a pandemic, and thus oseltamivir was needed for treatment. this figure was based on a combination of considerations including budgetary factors, an analysis of at-risk population demographics and evidence to support the efficacy of oseltamivir in a pandemic setting. subsequently, the target of population coverage was reduced to % in the national strategic plan that was endorsed by the cabinet (wibulpolprasert ) . government budgetary constraints and domestic manufacturing capacity were the principal drivers behind this shift in emphasis. international aid in supporting national stockpiles is minimal in thailand. the voice of the ministry of finance dominated the public health debate and strongly influenced the final strategic direction taken. the priority allocation is focused on rapid containment through treatment of people exposed to poultry and the health care workers who would be exposed to the very first human cases. in and , . million capsules of oseltamivir ( treatment courses) were bought from hoffman la-roche (interview # th ). domestic production capacity has since been developed and, since , a policy was implemented to increase domestic production year-on-year by treatment courses over years (interview # th ). in this research, we have explored the forces at play in three south-east asian countries' policy responses to hpai, a public health challenge that is of international concern in a region where the disease has become endemic in some areas and episodic in others. though all these countries have experienced hpai, they have responded in different ways. this paper explores the mesh of power relations between institutions and actors in the hpai response in each country. these actors included national advisory committees, large-and small-scale poultry producers with different vested interests (as evidenced notably in thailand), international organizations, academia, and human public health and animal health institutions (as shown in table ). through the lens of poultry vaccination and human antiviral policy, we have documented commonalities and divergences in responses that reflect institutional power relationships, national priorities, and the balance between overarching national economic and public health imperatives. the differences have implications for the development and sustainability of regional and global public health strategies for emerging infectious diseases. economic imperatives associated with poultry production, rather than public health imperatives, have been at the heart of poultry vaccine policy for hpai in indonesia, thailand and vietnam. these imperatives, in contrast to antiviral policy, have taken precedence over public health concerns and challenge the notion, through their divergence of approach, of both a regional strategy for hpai as well as broader notions of a 'one health' approach to emerging infectious diseases (king ) . the development of vaccination policies was based upon strategic goals that were neither explicit nor regionally consistent. in indonesia and vietnam, vaccination was introduced largely because of domestic economic concerns and a particular reading of the evidence on vaccination that supported 'control' and favoured mitigation rather than eradication. by contrast, thailand, with its substantial international trade in poultry, has adopted a policy goal of eradication. the evidence on vaccination was interpreted differently; not that mitigation might not be supported by vaccination, but that continued shedding of hpai might result, and international export markets fears be realized. though the poultry industry's economic imperatives appeared to be prioritized over human health concerns, the forces advocating this played out differently in different countries. in thailand, for example, though their voices were not loud, the public health actors took part in the discourse. likewise, in vietnam, public health actors worked in close cooperation with their veterinary counterparts. however, in indonesia, the voices of public health actors were largely muted. likewise, the voices of multilateral agencies charged with agricultural and animal welfare matters were dominant in support of policy formulation, and this, it could be argued, challenged the coherence of a regional human public health strategy. by contrast, the national domestic imperative in antiviral policy making across all three countries was public health. economic (and other sectoral interests) were largely absent from the debate. all three countries adopted policies that were in accordance with who recommendations and aligned with most other countries' policy approaches. though the evidence base in support of antiviral stockpiling was fragile, a consensus was achieved which was coherent regionally. budgetary constraints prevented stockpiling at the levels achieved in western countries. our research raises at least two potentially important questions. first, is coherence in policy making under the rubric of 'one health' necessary? that is, should concerns regarding public health and the threat of the emergence of novel infectious diseases mean that public health voices and their authority be more pronounced further 'upstream', where the forces that enable these diseases to exploit new ecological niches play out? the attention the notion of 'one health' is now receiving seems to suggest that the answer should be 'yes'. an institutional framework to support this 'one health' approach demands attention. the second question that emerges is whether national policy differences, driven by common themes (economic imperatives in the case of poultry vaccination), challenge regional (and global) public health strategies? does a policy of mitigation of hpai in one country and of eradication in its neighbour threaten sustainable regional (and indeed, global) public health? the answer to this question is more challenging. risk management of the pandemic threat, as opposed to risk assessment, is grounded in notions of national sovereignty (fidler ) . when sectors beyond public health are potentially affected by policy initiatives such as the economy, farming, industry and security, then it is difficult to envisage nation states in isolation adopting coherent policies. in south-east asia there are a multitude of regional institutions that have endorsed regional cooperation, including the association of southeast asia nations (asean), the ayeyawady-chao phraya-mekong economic cooperation strategy (acmecs), the asia-pacific economic cooperation (apec), the mekong basin disease surveillance network (mbds), as well as multilateral un agencies and their regional offices. the challenge may be, as with the answer to the first question, making these institutions 'work' to ensure the balance of national, regional and global needs and interests are met. partnership on emerging infectious disease research) and was funded through the international development research centre (idrc, www.idrc.ca). the funders played no role in design, data collection or analysis. equity, governance and financing after health care reform: lessons from mexico ku says government should go for avian influenza vaccine. bangkok, may the origins of pandemic influenza-lessons from the virus national coordination meeting for avian influenza control, surabaya, campaign management unit of directorate of animal health of the ministry of agriculture pandemic influenza preparedness in the asia-pacific region lesson learned from the control of avian influenza and preparedness plan for pandemic influenza of the ministry of public health (be. - ) department of livestock development, ministry of agriculture and co-operatives the cost of avian influenza in vietnam recommendation on the prevention, control and eradication of highly pathogenic avian influenza (hpai) in asia (proposed with the support of the oie influenza virus samples, international law, and global health diplomacy the political economy of avian influenza in indonesia potential impact of antiviral drug use during influenza pandemic the discovery of grounded theory national preparedness plan in response to avian influenza epidemic h n and human influenza pandemic. government decision no. /vpcp-nn vaccinate livestocks. directive of the prime minister international public health: diseases, programmes, systems and policies successful qualitative health research: a practical introduction the policy circle: a framework for analyzing the components of family planning, reproductive health, maternal health and hiv/aids policies the convergence of human and animal health one world -one health health% -% presentation.pdf the political economy of avian influenza in indonesia virus vs vaksinasi eu-japan threaten to ban thai chicken, if thaksin uses vaccine to break ai deadlock: watch out for illegal vaccine, people dead instead of chicken. bangkok, septemer vaccine policy & vaccination strategy for avian influenza. directive of director general of animal husbandry signing the tamiflu manufacturing plant in vietnam, decision no / qld-Ðk action plan on prevention of h n bappenas. national strategic plan for avian influenza control and pandemic influenza preparedness provision of oseltamivir. presentation at ai national committee panel expert meeting. jakarta, indonesia: secretary of directorate general of pharmaceutical presentation research & development of oseltamivir production for pandemic influenza preparedness. ministerial memo how prepared is europe for pandemic influenza? analysis of national plans avian influenza vaccination: oie information document, verona recommendations qualitative research and evaluation methods an analysis of the spatial and temporal patterns of highly pathogenic avian influenza occurrence in vietnam using national surveillance data falling on stony ground? a qualitative study of implementation of clinical guidelines' prescribing recommendations in primary care policy change and learning: an advocacy coalition approach the political economy of avian influenza in thailand. steps working paper cross-reactive, cell-mediated immunity and protection of chickens from lethal h n influenza virus infection in hong kong poultry markets referral system and current situation of human avian influenza. presentation at faculty of public health university of indonesia vaccination of fighting cocks will hit poultry export responses to avian influenza and state of pandemic readiness the political economy of avian influenza response and control in vietnam. steps working paper reforming the health sector in developing countries: the central role of policy analysis the national strategic plan for avian influenza control and influenza pandemic preparedness in thailand who guidelines on the use of vaccines and antivirals during influenza pandemics avian influenza: countries affected by outbreaks in birds guidelines for the management of a regional stockpile of oseltamivir cumulative number of confirmed human cases of avian influenza a/(h n ) reported to who the authors are grateful to dr chantana padungtod of the ministry of public health, thailand, for her substantial technical expertise and support on this project. this project, pandemic influenza preparedness: policy analysis, grant number - , was conducted under the apeir (asian none declared. key: cord- - sp uo authors: hughes, j. m. title: emerging infectious diseases: the public’s view of the problem and what should be expected from the public health community date: journal: infectious diseases from nature: mechanisms of viral emergence and persistence doi: . / - - - _ sha: doc_id: cord_uid: sp uo nan the public's view of major threats to health, as with other contemporary issues, is largely influenced by the media. as new health-related information is released from the clinical and research communities, it is translated for and disseminated to the public through a variety of mechanisms. in the past, healthcare providers served as the primary source of health-related information for patients. today, however, an unprecedented interest in health issues has led to intense media coverage of medical developments. moreover, the internet has given interested individuals rapid access to virtually unlimited sources of information. because of this symbiotic relationship between public interest and media attention, the actual impact or severity of a public health problem can be disproportionate to the amount of media coverage it receives, creating a climate of unnecessary fear and obscuring important health messages [ ] . in , the centers for disease control and prevention (cdc) released a series of reports describing ten great public health achievements in the united states during the th century [ ] . the topics were chosen based on their impact on reducing death, illness, and disability in the united states, and include advances such as vaccinations, improved maternal and child health, safer and healthier food, fluoridation of drinking water, and safer workplaces. also among this list is control of infectious diseases, resulting from improvements in sanitation, access to clean water, and the development and use of effective vaccines and antibiotics. so dramatic were these advancements that by the middle of the th century infectious diseases were no longer viewed as major public health threats in the united states and in many other developed countries. this false sense of security was short lived, however, as newly recognized and reemerging diseases continued to appear, many of which produced devastating consequences -most notably hiv/aids. advances against infectious diseases have not been universal. worldwide, infectious diseases continue to be a leading cause of death, profoundly impacting the developing world. the world health organization (who) estimates that nearly million ( %) of the approximately million deaths that occurred throughout the world in were caused by microbial agents [ ] (table ) . leading the list are lower respiratory infections, responsible for . million deaths per year, followed by hiv/aids ( . million), diarrhea ( . million), tuberculosis ( . million), and malaria ( . million) [ ] . the true burden of death from infectious diseases, however, is much higher since underreporting remains a major factor, particularly in the developing world. moreover, many deaths associated with infections are not categorized as infection related (e.g., deaths from cancers caused by infectious agents). despite the continued dramatic impact of these global killers, they receive very limited media attention -having become commonplace compared to the new and exotic. one of the reasons for this disparity has been the actual increase in the number of emerging and reemerging infections that have surfaced during the last years (box ). examples include newly recognized diseases such as hantavirus pulmonary syndrome, new variant creutzfeldt-jakob disease, and nipah and hendra viral diseases, the introduction and spread of west nile virus infection in north america, and intermittent outbreaks of ebola hemorrhagic fever in parts of africa. other major concerns include the increasing problems created by antimicrobial resistance and the continued threat of bioterrorism. in alone, a newly recognized coronavirus spread across five continents sickening more than , people and causing deaths from a new disease designated severe acute respiratory syndrome (sars) [ ] , the exotic animal trade resulted in the first cases of human monkeypox in the western hemisphere [ ] , and highly pathogenic strains of avian influenza virus killed humans and devastated the poultry industry in parts of asia [ ] -further heightening fears of pandemic influenza. this continual onslaught of newly identified and reemerging infectious diseases, along with increased concerns on the part of policymakers, the media, and an interested public, has created a new public health perspective and a heightened sense of vulnerability regarding infectious diseases. experiences with both naturally occurring and intentionally caused diseases have clearly demonstrated that infectious diseases can have severe consequences beyond public health, impacting national security and the global economy. local outbreaks are no longer considered limited threats but rather sentinel events capable of having much wider and potentially catastrophic implications. as a result, rapid and collaborative responses to infectious disease outbreaks have become both essential and expected. in , the institute of medicine published a report highlighting the increasing risks to public health posed by emerging microbial threats [ ] . the report, microbial threats to health: emergence, detection, and response, serves as an update to the institute's landmark report on emerging infections [ ] , which issued a strong caution against complacency toward infectious diseases and called for a rebuilding of the nation's public health system. the new report categorizes the spectrum of microbial threats into five areas: the global burden of aids, tuberculosis, and malaria; antimicrobial-resistant infections; vectorborne and zoonotic diseases; chronic diseases with infectious etiology; and microbes intentionally used for harm. the report also describes more than a dozen factors -human, biological, social, and environmental -that can work alone or in combination to produce a global microbial threat. examples of these factors include human demographics, behavior, and susceptibility to infection; changes in technology, industry, travel, and commerce; changing ecosystems and microbial hosts; and social and political factors such as poverty and other inequities, lack of political will, and the consequences of war and terrorism. as if a portent, the release of the iom report in march coincided with the outbreak of sars. the disease would prove to be an archetype of a global microbial threat, spreading rapidly as a result of international travel and requiring an international response to stop its spread. although the earliest notification about the illness came on february , , through a report posted on the program for monitoring emerging diseases, or "promed" [ ], the disease had been occurring in southern china since november -spreading largely to hospital workers who had treated affected patients. the global outbreak began on february , , when a guangdong physician, traveling while ill, spent one night in a hong kong hotel. although the exact modes of transmission are unknown, this individual would infect more than a dozen other hotel guests and visitors, many of whom served as index patients for major outbreaks in hong kong, singapore, vietnam, and canada [ ] (fig. ) . in singapore, more than of the country's sars cases were linked to a single individual who became infected at the hong kong hotel [ ] . much has been learned from these recent outbreaks of emerging infectious diseases, especially sars (box ). despite its tragic health consequences and strong social, economic, and political impact, sars was fortunately not the feared "big one," appearing to spread primarily by droplets during close contact. the sars outbreak uncovered both strengths and weaknesses in global disease detection and response efforts and can therefore serve as a strong warning as well as an opportunity to prepare for future threats [ ] . sars clearly showed the unpredictability of emerging infectious threats and the vulnerability of even the most developed nations. the virus did not respond to treatment, and no vaccine was available. the use of strict isolation and quarantine precautions -some involving tens of thousands of individuals -proved the best means of stopping the epidemic. box . improving preparedness and response: lessons learned from recent outbreaks -strengthening existing and developing new national and international partnerships -training and educating a multidisciplinary workforce -ensuring "full use" of investments -encouraging transparency and political will -fostering a global commitment to address inequities -developing and implementing preparedness plans and research agendas -proactively communicating with health professionals, the media, and the public while the first line of defense in controlling an outbreak remains strong national surveillance systems that can readily detect outbreaks, the sars experience highlighted the importance of global disease detection efforts [ ] . the same interconnected world that enables microbes to rapidly cross borders can also work to effectively stop their spread, providing an opportunity for establishing surveillance systems that can approach real time. for sars, the internationally coordinated response led by who allowed clinical, research, and public health experts around the world to exchange information on the new disease as quickly as it evolved. part of this effort included the who collaborative multi-center research project on sars diagnosis, a network involving more than a dozen laboratories and countries. in less than a month, three of these laboratories determined the cause of the illness -a previously unrecognized coronavirus. also playing a major role in the response was who's global outbreak and response network (goarn), a surveillance and response system of more than organizations worldwide. although goarn responds to dozens of outbreaks in developing countries each year, the sars outbreak represented its first response to an internationally spreading illness [ ] . among goarn's most visible partners are the national influenza centers (http://www.who.int/csr/disease/influenza/ centres /en/). established in the s, this expansive network of more than institutions in over countries is responsible for tracking influenza viruses to guide vaccine development and to recognize variants that may be capable of producing a pandemic. another message clearly indicated from recent emerging and reemerging infectious diseases is the need to strengthen existing and establish new linkages between the human and animal health communities. the majority of pathogens implicated in recent outbreaks, as well as most of those identified as potential bioterrorism agents, are vector-borne or zoonotic microbes, many of which have crossed the species barrier from animals to humans [ , ] (box ). continued urbanization and other environmental and human demographic changes suggest that this emergence of new zoonotic diseases will likely continue, requiring a corresponding convergence of highly trained human and animal health experts to effectively address them. ensuring that these experts have the capacity to respond to a broad range of infectious threats requires recruitment efforts and training programs across a variety of disciplines including clinical, laboratory, epidemiologic, and behavioral research. national and international collaborations among a skilled workforce are critical for improving global disease detection and ensuring an effective response. such investments in human resources must also be met with improvements in research facilities and capacities. the benefits of such efforts can be substantial, extending beyond national borders and allowing for a "dual" or "full" use of resources. in the united states, investments made to strengthen national bioterrorism preparedness and response efforts over the past several years have improved overall preparedness for public health threats. an example is the laboratory response network (lrn), a network of public and private laboratories established in by the centers for disease control and prevention (cdc) to respond quickly to acts of chemical and biological terrorism, emerging infectious diseases, and other emergencies. in , the lrn provided valuable diagnostic services for sars, monkeypox, and avian influenza, in addition to daily monitoring of potential bioterrorist agents. the critical importance of transparency and political will in controlling infectious diseases was also evident during the sars outbreak. china's months-long delay in reporting the outbreak not only prevented efforts to contain the epidemic locally but also proved most costly for its own region. in contrast was vietnam, one of the earliest countries affected by the outbreak and the first to contain it [ ] . dr. carlo urbani, an infectious disease physician working in hanoi for who, recognized the unusual severity of the disease and quickly instituted infection control precautions, sadly too late to prevent his exposure to the infection that would cause his death. dr. urbani's prompt recognition along with vietnam's commitment and global cooperation effectively limited the spread of sars in vietnam. china ultimately demonstrated one of the most extraordinary acts of political will in addressing the epidemic when more than , construction workers built a -bed hospital in approximately one week. the importance of political will in addressing infectious diseases continues to be demonstrated most directly by its absence -an all too frequent obstacle to eradication efforts for vaccine-preventable diseases such as polio and measles. closely tied to political will is a commitment on the part of high income countries to help address inequities -the social, economic, and health disparities that contribute to the spread of infectious diseases [ , ] . in , at the united nations millennium summit, representatives from nearly u.n. member states resolved to help end human poverty and its ramifications. termed the "millennium development goals," this agreement requires countries to increase their efforts to address inadequate income; lack of food, clean water, and health care; substandard education; gender inequality; and environmental degradation. the goals also call for renewed commitment in addressing the disproportionate impact of infectious diseases on many of the world's poorest regions.a more recent undertaking is "the grand challenges in global health" initiative, funded by the bill and melinda gates foundation and administered by the foundation for the national institutes of health. this initiative was established in to help develop solutions to critical problems that perpetuate the spread of disease in the developing world. such international undertakings directed toward the diseases causing the greatest morbidity and mortality in the developing world should be priorities for wealthier countries. in addition to meeting enormous humanitarian needs, efforts to address these daunting global killers can help remove major obstacles to economic growth and development, thereby strengthening public health infrastructures and disease detection capacities worldwide. perhaps most evident during the sars outbreak was the crucial need for rapid dissemination of accurate information -both for the medical and scientific experts confronting the epidemic and for a concerned public. during the sars epidemic, the availability of electronic communications enabled networks of laboratory scientists, clinicians, and public health experts to share information and rapidly generate a scientific basis for public health action against a novel disease [ ] -a major step toward lessening the health consequences of the outbreak. these extraordinary efforts and swift actions, however, did not prevent the severe social and economic ramifications that resulted from sars. these consequences, largely generated by the fears and perceptions of a vulnerable public, highlight the critical need to communicate timely and accurate information in the face of scientific uncertainty. proactive communications directed at health professionals can enhance the ability of those on the front lines to detect the unusual -e.g., test results or patient symptoms that could signal the occurrence of a new health threat. similarly, proactive and open communication between public health officials and policymakers is essential for sound public health action. finally, proactive communications through public health websites and with the media can help ensure broad dissemination of timely and accurate risk information to members of the public that can enable them to make important decisions in protecting their health. perceived threats and real killers ten great public health achievements -united states the world health report : changing history. world health organization the severe acute respiratory syndrome the detection of monkeypox in humans in the western hemisphere outbreak news: avian influenza a (h n ) lederberg j (eds) for the committee on emerging microbial threats to health in the st century, board on global health, institute of medicine ( ) microbial threats to health: emergence, detection, and response the committee on emerging microbial threats to health, division of health sciences policy, division of international health, institute of medicine ( ) emerging infections: microbial threats to health in the united states update: outbreak of severe acute respiratory syndrome -worldwide severe acute respiratory syndrome -singapore the international response to the outbreak of sars in population biology of emerging and re-emerging pathogens severe acute respiratory syndrome (sars) -multicountry outbreak -update global health improvement and who: shaping the future the sars response -building and assessing an evidence-based approach to future global microbial threats key: cord- -zoxgacwy authors: francis, leslie p.; battin, margaret p.; jacobson, jay; smith, charles title: syndromic surveillance and patients as victims and vectors date: - - journal: j bioeth inq doi: . /s - - - sha: doc_id: cord_uid: zoxgacwy syndromic surveillance uses new ways of gathering data to identify possible disease outbreaks. because syndromic surveillance can be implemented to detect patterns before diseases are even identified, it poses novel problems for informed consent, patient privacy and confidentiality, and risks of stigmatization. this paper analyzes these ethical issues from the viewpoint of the patient as victim and vector. it concludes by pointing out that the new international health regulations fail to take full account of the ethical challenges raised by syndromic surveillance. protection of populations from infectious disease requires effective surveillance to identify diseases and disease trends. the better the surveillance, the more quickly outbreaks can be identified and contained. this is especially important for a rapidly spreading condition with high levels of mortality and morbidity, as human-to-human pandemic influenza is thought likely to be. yet there are many barriers to effective surveillance, including inadequate public health systems, limited resources, reluctant population groups, and ethical objections. in this contribution, we discuss how an ethical perspective we have developed-what we call "the patient as victim and vector", or "pvv" for short (battin et al. )-can help in analyzing ethical concerns about a new and important form of surveillance: so-called "syndromic surveillance", that employs a variety of innovative information technologies to monitor for clusters of symptoms or complaints. several ethical concerns have been thought to apply to syndromic surveillance. these include the possibility that access to individuals and collection of information from them may occur without their consent; the potential for loss of privacy and confidentiality; and, the risk that individuals or groups may be stigmatized, physically harmed, or otherwise victimized by the information collected. there are political concerns as well: the establishment of novel data-gathering means without public knowledge, decision-making or oversight. on our pvv perspective, we conclude that robust surveillance regimes of the type envisioned by syndromic surveillance can only be ethically justified, despite their anticipated benefits, if they are accompanied by attention to the victim-needs of those about whom data are obtained. these victim-needs include transparency and oversight, protection from harm, and access to preventives or treatment to the extent possible, but do not extend to informed consent or protection of privacy in every instance. in considering the ethical issues raised by syndromic surveillance, moreover, it is especially important to distinguish privacy as access to individuals in the initial information-gathering encounter, and confidentiality as protection of the transfer of identifying or identifiable information about them. surveillance has been called the "backbone" of public health efforts in disease prevention and control (gostin and berkman , ) . individual case surveillance identifies people with particular diseases (such as tuberculosis or syphilis) and provides the option to intervene to treat and to stop spread. in its traditional form, such case surveillance involves specification of a list of "reportable" diseases to an entity such as a department of health, followed by treatment and/or contact tracing as deemed necessary. it also involves reporting or monitoring of laboratory testing results for identified organisms, toxins, or other suspected agents of disease. in complement, statistical surveillance identifies disease trends in populations: incidence, prevalence, distribution, and the like (stoto ) . these traditional surveillance methods begin with a determination of the diagnoses, or agents of disease, that are thought to be of public health interest. for example, the world health regulations in effect until required reporting of cholera, yellow fever, and plague-but only these three diseases (chretien et al. stat. § - ) . other recent proposals have extended surveillance beyond contagious disease and environmental toxins, the traditional domains of public health, to identify incidence and prevalence of diseases such as diabetes-an expansion that has come under criticism (mariner ) . however, with emerging contagious diseases such as hiv or sars, new strains of influenza, or as-yetto-be-imagined agents of bioterrorism, illness may reach pandemic proportions if effective surveillance must wait upon identification of a diagnosis or disease-causing agent that is the object of interest. instead, observation and subsequent investigation of behavioral or symptom patterns of potential significance is an important way of ascertaining a developing public health threat. the basic idea of such "syndromic surveillance" is to collect real-time data about disease indicators in order to detect possible outbreaks of diseases even before the diseases themselves have been identified (buehler et al. ; mandl et al. ) . syndromic surveillance thus relies on a wide variety of data available in electronic or other forms beyond those used in traditional surveillance (chretien et al. ; heffernan et al. ) . this includes information such as data about chief complaints, symptoms, medication sales; grocery store purchases such as pediatric electrolyte formulas or even orange juice; absenteeism from work or school; or internet queries for topics such as "influenza" or "fever." for example, an important data source in syndromic surveillance is emergency room visits. one of the measures of disaster preparedness employed in the american college of emergency physicians' report card on the status of emergency medicine in the united states is the presence of real-time surveillance systems for common emergency department presentations (american college of emergency physicians ). as an illustration, north dakota receives daily electronic feeds of chief complaint data from eight large emergency rooms in the state (north dakota health department). such feeds can alert public health officials about unusual clusters or increased rates of symptoms such as diarrhea, respiratory illness, or joint pain-and trigger further investigation about what might be causing the observed phenomena. in europe, syndromic surveillance has been developed quite extensively (smith et al. ; josseran et al. ). syndromic surveillance, as thus understood, is based on novel data sources and data-mining techniques: emergency department data in electronic form, electronic medical records, electronic prescription data, pharmacy purchases, reported absenteeism, and traffic on the web in particular (sengupta et al. ; mandl et al. ) . such surveillance presents new possibilities and new challenges. one difficulty in the construction of syndromic surveillance techniques is validation: for example, is an increase in certain pharmacy purchases indicative of a rise in respiratory disease? (one study concludes that it is (van den wijngaard et al. ) .) other studies have concluded that reports of respiratory symptoms in pediatric emergency rooms are indicative of a rise in respiratory syncytial virus (bourgeois et al. ). on the other hand, purchases of antivirals may be generated by individual decisions to stockpile after publicity about influenza, rather than with any increased rates of influenza itself (centers for disease control ). concerns have also been raised about the accuracy of syndromic surveillance at single institutions; however, the problem may be limited data rather than methodological difficulties with syndromic surveillance per se (weber and pitrak ) . even when measures are validated, sensitivity and specificity pose additional problems. it is desirable to have highly sensitive measures to avoid missing detection of potentially serious outbreaks, but this raises concerns about false positives and attendant costs and risks (buehler et al. ) . several features of syndromic surveillance are particularly noteworthy for ethical purposes. with traditional reporting systems, conditions of interest are identified in advance. this identification is typically codified by legislative action or administrative rule-making. there has thus been a degree of public oversight of the decision to make a disease reportable. however, as we detail below, even recent and proposed reforms of public health law have not anticipated the full range of possibilities syndromic surveillance may present. thus, as it has developed to date, syndromic surveillance has not been subject to the level of public scrutiny that has attended traditional public health surveillance. legally-established reporting regimes typically also implement mechanisms for protecting the confidentiality of any reported data, but comparable regimes have not been fully developed for protecting the data obtained for purposes of syndromic surveillance. moreover, because in traditional surveillance the need for reporting is identified in advance, informed consent discussions of health care providers with their patients can include any relevant reporting requirements. a physician recommending testing to a patient for hiv or syphilis can explain the significance of a positive test result before the patient agrees to the test. with new methods of syndromic surveillance, by contrast, issues of informed consent and data use are far less well analyzed and understood. as it involves the identification of patterns of interest, patients and providers may not know in advance that a particular symptomatic report entered into an electronic medical record will be of any significance whatsoever: whether this fever triggers interest may only be known after a pattern of fevers is observed in an interoperable set of electronic records. moreover, no informed consent process at all is involved in such activities as purchase of an over-the-counter antidiarrheal or a search of the web for information about managing fever. some syndromic surveillance collects electronicallystored data that includes identifying information about individual patients, allowing for possible investigation if patterns of concern are identified ( nordin et al. ) . such data collection practices pose risks to patient confidentiality if data security is imperfectly protected (myers et al. ) . to be sure, some syndromic surveillance in the united states involves "de-identified" electronic health data, health records from which a defined list of identifying information has been removed as set out in the federal privacy rule for medical information transmitted in electronic form (hipaa ). however, increasingly concerns have been raised about whether de-identified data can be readily re-identified, especially when data sets are combined (porter ) , as data sets are likely to be under robust syndromic surveillance regimes. consider, for example, combining electronic medical records, pharmacy purchase data, and grocery store purchases of over-the-counter remedies using a frequent-shopper discount card that contains purchaser identifying information. moreover, entities issuing de-identified data sets may keep coded identifiers to permit reidentification in case of public health need (sengupta et al. ) . thus there may be risks to patient confidentiality even when de-identified data sets are employed for syndromic surveillance. these very real risks to confidentiality highlight the importance of careful consideration of regimes for data protection if syndromic surveillance is to be employed. even when re-identification of individual patients is unlikely, syndromic surveillance may pose risks of stigmatization of both groups and individuals whose group membership is known (national committee on vital and health statistics , ) . this is of particular concern given the imperfect validation of syndromic surveillance techniques, as well as the risks of false positives when the emphasis is placed on detection methods with high sensitivity (stoto et al. ). syndromic surveillance may identify suspected higher rates of illness or disease risk in particular populations. one quite recent example of group stigmatization involved an hiv exposure alarm among students at a particular school (whose school population happened to be % african-american) (gay ) . stigmatization has also been alleged concerning minority patients with diabetes in new york city (goldman et al. ). the untoward result may be prejudicial to everyone who meets the given description, without regard to the accuracy of the initial suspicions and without concern for them as people, too. but there is surely more to come than the syndromic surveillance methods we have seen to date. the data collection in syndromic surveillance, as it has developed so far, is just the beginning. surely, as more robust systems of electronic health records are put into play, more extensive data mining for public health purposes will come into play. but there is more. consider the thought experiment-or perhaps realistic proposal-that we developed elsewhere: universal rapid testing for infectious disease in airports, on public transit, at schools, workplaces, movies and sporting events (battin et al. , ch. ). or suppose that it were possible to detect overall temperature levels in a population by means of remote thermal imaging. suppose this could be done in such a way that no one was aware that data were being collected and no information about particular individuals was included in the data collection. all that was ascertained was the occurrence of shifts in the amount of heat emitted by bodies of a given size in a particular area. such sensing is a technologically possible method for determining whether there has been an increase in bodily temperatures in a population-and a possible method for determining whether a corresponding rise in infection rates has been occurring in a population. although remote thermal sensing of people while they are in their homes would likely be an unreasonable search and seizure under united states law, this use of thermal imaging could be a very effective way of ascertaining increased rates of infectious disease in a population, perhaps even more effective than monitoring data about purchases of aspirin or acetaminophen in local pharmacies. a central goal of surveillance is to identify threats to the public health so that effective intervention can take place. with transmissible disease, surveillance focuses on the individual as a source of illness to be identified and contained, or as a source of information about transmission. in the language of the analysis we have developed elsewhere, that of the patient as "victim and vector", an aspect of surveillance is to regard everyone as potential vectors from whom for a description of the racial stereotyping that occurred to students at the school, see brown ( ) . initial indications are that the scare was a false alarm (bernhard and giegerich ). in kyllo v. united states, u. s. ( ) , the supreme court held that it was a violation of reasonable expectations of privacy to use a remote thermal sensing device to measure differences in the exterior temperature of a dwelling, and thus an unreasonable search and seizure without a warrant. in thus ruling, the court attempted to fashion doctrine that would apply well beyond the crude sensing device employed by the police to ascertain from differential outside temperatures of the house whether kyllo was using the high-temperature lamps to cultivate marijuana within. justice stevens, in dissent, argued that the case was just a garden-variety use of external observation, albeit enhanced-just like the visual observation that snow was melting differentially in areas of the home's roof. this analysis would not apply, however to measurements obtained when someone is outside of the home. also worthy of note, the new international health regulations specifically exclude thermal imaging from the definition of invasive procedure (international health regulations, art. (definitions)). society is to be protected. syndromic surveillance is no exception to this generalization. as we have argued, however, the field of bioethics has been impoverished by the failure to attend to persons as both victims and vectors (battin et al. ). as human animals, we are way stations for microbial transmission, biologically interrelated in networks of organism interchange. seen from the perspective of our ordinary lives, we are more-or-less susceptible to infection: some are immunecompromised, some already ill, some in conditions of poverty where disease transmission is especially high and susceptibility is great, and some protected by living in conditions of apparent relative safety. however, there is a sense in which no one is immune: we are all potentially victims and vectors to each other, unknown and unknowingly. as victims, we are concerned that vectors may transmit illness to us; but as vectors, we are victims too. we exist behind what might be thought of as an infectious-disease veil of ignorance; our ethical judgments must come to terms with this feature of our human condition. this is not a matter of mere self-interest, requiring us to calculate from our own particular circumstances how likely infection is to occur. it is a deeper metaphysical point: both the victim and vector perspectives belong to everyone, all of the time. to the extent that it is effective in detecting potentially dangerous disease-an improvement on other surveillance techniques-syndromic surveillance would be defensible from the perspective in which we do not know whether we are victims or vectors. it should be emphasized that this justification is contingent on the efficacy of syndromic surveillance: if syndromic surveillance raises insurmountable technical difficulties, cannot be validated, is less sensitive or specific than other surveillance methods, or even poses greater risks than these other methods for limited or no improvement, it would not be justified out of concern to protect ourselves from potential vectors. but even if syndromic surveillance is justified as a means for preventing disease spread, this is not the end of the ethical story; any such justification would also warrant attention to ourselves as victims, in a number of respects. first of all, as victims we would want to be sure that surveillance is not more extensive than apparently needed to detect outbreaks of potentially serious disease. widespread "fishing" expeditions of uncer-tain validity would be unacceptable to us as victims. otherwise, the risks to ourselves as victims who are affected by surveillance might be greater than the gains to ourselves in being protected from potential vectors. but this requirement of narrow tailoring is just a beginning. additionally, as vectors who are also potential victims we would want assurance that we are protected to the extent possible in the course of whatever surveillance takes place. such protection starts by subjecting surveillance methods to public oversight. at a minimum, there must be transparency about what is happening with respect to surveillance: public knowledge of what surveillance is taking place and how it is being conducted. without such transparency, immense amounts of data may be collected about people, combined and recombined, without any public knowledge of what is happening whatsoever. there should as well be some kind of public decision making process-legislation or administrative rule-making, for example-to scrutinize and accept the surveillance process. finally, there should be public oversight of surveillance: a mechanism for assessing whether methods being employed are appropriately limited to need, and that people are informed if there are breaches of guarantees such as confidentiality. arguably, such public knowledge and oversight is the best available substitute for an informed consent process on the individual patient level. if there is full public information about what surveillance is being done, as well as oversight through the political process, then the political process might be viewed as analogous to community consent of the form utilized in research when subjects cannot be identified in advance (mcclure et al. ) . however, it is important to note that so-called "community consent" models as they are currently implemented may fail to communicate adequately with community members about planned research. as victims, we would want to insist that syndromic surveillance be fully vetted at the political level, and that there be ongoing public oversight to ensure that safeguards are employed as promised. one of the most serious objections to any surveillance is patient privacy and confidentiality. as we have already indicated, the novel uses of data in syndromic surveillance may place serious pressures on confidentiality. to take just one example, if a novel influenza strain appears as it apparently did in the spring of , intense efforts may be devoted to identifying and detaining air travelers with potential exposures (centers for disease control ). although these two concepts are often used interchangeably, privacy refers to the initial intrusion-the contact from which data are obtained-and confidentiality refers to individual control over the information thus obtained. from the victim/vector perspective, it is not clear that privacy is the more important value. protection from each other as vectors may be significantly inadequate without the initial access that allows data to be gathered. at the same time, if confidentiality is not protected and people are identified, then risks of harm may be significant. these risks stem from the information becoming known, not from its being gathered in the first place; the only likely harm, for example, from a grocery store keeping an electronic record of an aspirin purchase, even a purchase linked to a particular individual, might be identification of that individual as being ill. the reason for protecting privacy is not the harm involved in the moment of data gathering; it is instead the concern that, once gathered, the data will inevitably come to light. to put the point succinctly, confidentiality is the reason for protecting privacy, not the reverse (francis ) . because of the more extensive threats to confidentiality involved in syndromic surveillance, reconsideration of what data confidentiality and security require in this context is especially urgent. as victims, we would like to be assured that we will not be publicly identified as disease threats-and that if we are identified at all, it will be for our own protection. this requires assurance that when a disease threat is determined and individuals must be contacted, as when codes are broken with de-identified data sets to all for individual contact, the contact will include offers of treatment-or if treatment is not yet a possibility, with assurances of protection from harm to the extent possible. it also requires assurance that we will be told if confidentiality is ever breached in this or other ways, so that we may know about the need for protection and be able to take steps to avoid harm from the confidentiality breach. finally, as victims we will also be concerned about risks of stigmatization. to some extent, transparency and political oversight can help to modulate these risks. but the risks remain, at least in a world in which fear and prejudice have not been forgotten. one critic of new york city's surveillance for diabetes argued that these risks of harm demand that surveillance be coupled with the availability of resources for prevention and treatment. these initiatives do not balance heightened surveillance and intervention with the provision of meaningful safeguards or resources for prevention and treatment. the programs intrude on the doctor-patient relationship and may alienate the very patients and health professionals they aim to serve. (goldman et al. ) one way to blunt or mitigate the risks of stigmatization is to make prevention and treatment available as a complement to surveillance activities-to everyone, to the extent possible. if prevention and treatment are available, people will have less reason to fear and to regard others as ones-to-be-feared. moreover, prevention and treatment are what people have to gain from the risks of having data about them be used in efforts to identify disease early on. nonetheless, the most difficult cases are those in which prevention and treatment are not available, because supplies are scarce, treatment is very expensive, or treatment has yet to be developed. with pandemic h n influenza, this is exactly the fear: that it will be highly lethal and that anti-virals will prove ineffective. as victim-selves, the best we can do in such circumstances is to cooperate in efforts to stop disease at the earliest point. thus we would support syndromic surveillance if it seems likely to be effective. but we would want the oversight to be very careful indeed-with ongoing attention paid to what surveillance techniques are being employed and whether they continue to be needed or effective. and we would want society to continue to be engaged in the project of considering how to respect people who are victims of disease, even if their conditions cannot be ameliorated. although the need for reform of public health laws has been widely recognized, especially in the wake of fears of pandemic influenza and the realities of sars and - , reforms that have been enacted may not have caught up fully with the possibilities of syndromic surveillance. legal regimes governing surveillance function at many different levels, from the world health organization to the very local. here we give a snapshot of recent reforms in the who international health regulations that are important but that may not grapple with the full ethical implications of syndromic surveillance. although these reforms contemplate more extensive and effective surveillance, they are non-specific about whether what is contemplated is a wider range of traditional disease surveillance or shifts to syndromic surveillance. in june of , the new international health regulations went into effect. these regulations require states parties to meet specified functional requirements for surveillance. "surveillance" in the regulations is defined as "the systematic ongoing collection, collation, and analysis of data for public health purposes" (international health regulations, art. ). the regulations thus represent an enormous advance over the prior regulations, which only required reporting of three identified diseases: cholera, yellow fever, and plague. at the local level, functional requirements include the capacity to detect events involving disease or death above expected levels in all areas of the territory (international health regulations, annex i). they also include the ability to report available information to the relevant response level-information including clinical descriptions, laboratory results, sources and types of risk, numbers of human cases and deaths, conditions affecting spread, and health measures taken. local authorities are also expected to be able to implement preliminary control measures immediately. at the intermediate level, requirements include confirmation of the status of events and the ability to support or augment control measures. they include, in addition, assessment of the urgency of the situation and the ability to transmit information about any urgent situations to national authorities. national authorities, in turn, must be able to assess events reported as urgent and to report as necessary to the who. they must also be able to provide adequate public health responses on a -hour basis. these are clearly extensive requirements and may be difficult to meet in economically challenged areas of the world. in recognition, the regulations also commit more affluent states parties to help the less affluent to comply with the requirements. they also permit a two-year grace period for implementation generally, and longer periods for compliance with requirements such as adequate response capability. as of february , all nations were states parties to the ihr (http://www.who.int/csr/ihr/states_parties/ en/index.html). notably, the united states has become a state party under a reservation: the insistence on implementing the regulations consistently with federalism. three limiting "understandings" were also submitted by the united states: that the notification requirements apply whether the emergency is natural or human-caused in origin; that the requirement to report if "practicable" known emergencies outside the country's territory does not apply in cases that would jeopardize the effective operation of u.s. armed forces; and that the ihr do not create enforceable private rights of action (http://www.who.int/csr/ihr/ states_parties/en/index.html). although the new regulations are widely regarded as a major step forward, concerns remain. these include the lack of technical capacity to implement the regulations, issues of resource allocation, concerns about privacy, and questions about overall governance (plos medicine editors ; baker and fidler ) . the editors of plos medicine, for example, point out that most of the investment in preparing for pandemic influenza has involved stockpiling resource in developed countries (plos medicine editors ) . other discussions praise the wider reach of the regulations about what are regarded as events of public health significance, but also express concern about whether the investment will be there to build the technical capacity for the required surveillance (sturtevant et al. ) . despite the advances they represent, it is controversial whether the regulations in their final form are meant to include the capacity for syndromic surveillance. baker and fidler ( ) contend that although syndromic surveillance was discussed, the decision was not to include it in the regulations because of concerns about validity. however, in fashioning the requirements for surveillance and reporting, the regulations define a public health emergency of international concern as "an extraordinary event which is determined . . . to constitute a public health risk to other states through the international spread of disease and to potentially require a coordinated international response" (international health regula-tions, art. ). this definition elides whether the reference is only to identified diagnoses or agents or includes syndromic identification as well. although the definition of "surveillance" quoted above is surely broad enough to include syndromic surveillance, nothing more specific is stated about the possibilities. in discussing the resource issues raised by the regulations, chretien et al. ( ) give illustrations of successful establishment of syndromic surveillance capacity in indonesia and peru. it seems increasingly likely, moreover, that as syndromic surveillance techniques become better developed, pressures will increase for their use in detecting emerging disease before spread becomes likely-especially, we might hypothesize, spread to more affluent areas of the world. thus if the regulations encompass syndromic surveillance, they are insufficiently attentive to the ethical issues we have raised. the regulations state that all measures should be implemented in a transparent and non-discriminatory manner (international health regulations, art. ), but do not set out any specific requirements for what this might involve. with respect to privacy, article states both that data should be processed anonymously and that personal information may be used when needed, so long as they are processed fairly and not kept longer than necessary (international health regulations, art. ). these provisions are quite vague, however, and do not attend specifically to the privacy and confidentiality issues that may be raised by increasing use of non-traditional forms of surveillance. although the regulations commit more affluent countries to helping others in developing surveillance capacities (international health regulations, art. ), they do not include commitments to more extensive development of the health infrastructure needed to ensure that treatment is available to the extent possible for those who are identified as disease threats. so-called "syndromic surveillance" poses novel and unexplored possibilities for protection from disease, protection that as victims we would find especially important when diseases are severe and treatments are unknown or inadequately distributed. however, because of the risks to confidentiality and concerns about stigmatization, data use in syndromic surveillance may pose more extensive risks to perceived vectors than more traditional forms of surveillance. as attempts to monitor for emerging pandemic infections continue to develop, the ethical problems raised by syndromic surveillance will need much further attention. national report card on the state of emergency medicine global public health surveillance under new international health regulations the patient as victim and vector: ethics and infectious disease state finds no hiv outbreak at normandy high; 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maracy, mohammad r; yarmohammadian, mohammad h; ardalan, ali; keyvanara, mahmood title: preparedness of community-based organisations in biohazard: reliability and validity of an assessment tool date: - - journal: fam med community health doi: . /fmch- - sha: doc_id: cord_uid: b h xog the purpose of this study was to develop a tool for community-based health organisations (cbhos) to evaluate the preparedness in biohazards concerning epidemics or bioterrorism. we searched concepts on partnerships of cbhos with health systems in guidelines of the centers for disease control and prevention and literature. then, we validated the researcher-made tool by face validity, content validity, exploratory factor analysis (efa), confirmatory factor analysis (cfa) and criterion validity. data were collected by sending the tool to cbhos serving under supervision of iran’s ministry of health. opinions of health professionals and stakeholders in cbhos were used to assess face and content validity. factor loads in efa were based on three-factor structure that verified by cfa. we used spss v. and mplus software for statistical analysis. about health-based cbhos participated. after conducting face validity and calculating content validity ratio and content validity index, we reached items in the field of planning, training and infrastructure. we conducted construct validity using cbhos. three items exchanged between the fields according to factor loads in efa, and cfa verified the model fit as comparative fit index, tucker-lewis index and root mean square error of approximation were . , and . , respectively. the cronbach’s of the whole tool was . . spearman correlation coefficient confirmed criterion validity as coefficient was . . planning, training and infrastructure fields are the most important aspects of preparedness in health-based cbhos. applying the new assessment tool in future studies will show the weaknesses and capabilities of health-based cbhos in biohazard and clear necessary intervention actions for health authorities. community-based organisations (cbos) are indispensable partners in health systems. in disasters and management of epidemics, some governments cannot provide an adequate response with limited resources. these organisations have the necessary knowledge about community culture, structure and resources, and facilitate access to deprived and marginalised communities in times of need. besides, federal emergency management agency and centers for disease control and prevention (cdc) have encouraged coordination with volunteer organisations whose goal is to support and coordinate with government agencies in disasters. contrary to these requirements, there is limited evidence regarding the readiness of these organisations for bioterrorism or epidemic/pandemic. for instance, in order to prevent the spread of zika virus, organisations are expected to have very high communication skills to warn high-risk groups. in a study by zhi et al; they emphasised the need to educate the staff of faith-based organisations especially in exercises and drills. eventually, clawson et al examined the community health centres' preparedness in the case of bioterrorism. they demonstrated that less than half of the centres possessed bioterrorism preparedness in their plan and only one-third among them included bioterrorism preparedness in their written policies. frequent religious mass gatherings and food serving in customs gathering exposure iran in the various potentiality of outbreaks and bioterrorism. [ ] [ ] [ ] besides, limited access to resources in epidemic seasons in developing countries like iran would worsen the situation. although iran has an extensive community-based primary healthcare (phc) network that raise community awareness of local risk profiles and aid community, a population-based study revealed that overall community awareness and preparedness for even routine disasters is low. [ ] [ ] [ ] iran's phc network has taken some advocacy and training programmes focusing on community partnership. cbos can equip public health officials with information about vulnerable groups and how to meet their particular needs. however, iran still lacks an assessment tool evaluating the preparedness of cbos in biohazards. according to the above evidence, the necessity of formulating specific criteria in open access the context of preparedness for cbos is obvious. therefore, this study aimed to develop a comprehensive tool to evaluate the level of cbhos' preparedness in times of epidemics or bioterrorism thereby identifying the prerequisites of cbhos' participation for government decision makers. participants and sampling method the study population was cbhos in the country. based on cochrane's formula, approximately samples should be included in the study. receiving a compiled list of cbos from vice-chancellery for social affairs, the tool was disseminated in cbhos' social networks. additionally, we sent the participation appeal through contact channels five times for each cbhos. these are organisations that, according to experts from the centers for disease control at deputy of health, possess the eligibility and capabilities necessary to work with the health system as an assisting or cooperating agencies during biohazards. inclusion criteria were: cbhos that served more than clients and provide services to clients at the time of the study with a registered office to carry out their duties. the identity of the person filling the questionnaire and their organisation remained disclosed in the data collection forms; instead, a code was assigned at the time of data entry. face validity, content validity, exploratory factor analysis (efa), confirmatory factor analysis (cfa) and criterion validity were used to validate this researcher-made tool. assessing the face validity, health professionals in disasters/emergencies and some stakeholders from cbhos read questions of the instrument to examine the level of difficulty, the degree of mismatches and to check the ambiguity of phrases and meanings of words, thereby making appropriate changes in persian based on their comments. the qualitative content validity determined by the grammar, the proper use of words, the importance of questions, the ordering of questions and the time required to complete the toolkit were all taken into consideration. for quantitative content validity, content validity ratio (cvr) was used to ensure that the most important content was chosen (necessity of question), and the content validity index (cvi) was used to ensure using the best way to measure content. cvr is used to ensure that the most relevant and correct content is selected. in quantitative content validity, after collecting expert opinions, if the cvr based on lawshe's table was more than % and the cvi based on the davis study was over %, the necessity, relevance, transparency and simplicity of the questions were acceptable. we used efa to determine the factors loads based on three factors extracted as the assumption of this study. cfa, also, was used to verify the factor structure and the hypothesis that a relationship between observed variables and their underlying latent constructs exists. in order to assess the concurrent criterion validity, the 'organisational preparedness checklist for a major earthquake or other large-scale disaster events' questionnaire developed by austin et al was applied. the questionnaire consists of phrases in four periods that include 'last year', 'between year to years', 'over the past years' and 'never'. the researcher-made tool was designed to determine the preparedness level of cbhos in biohazards. after studying the guidelines of office of the assistant secretary for preparedness and response (aspr) [ ] [ ] [ ] along with other information sources, the research team eliminated duplicates/repetition of initial items pool. the researchers extracted all concepts promoting the partnership and cooperation of cbos with the health system under the first set of capabilities named 'community preparedness' in the public health preparedness capabilities guideline. then, fundamental concepts of the tools that are available from the literature were integrated into the primary tool to evaluate cbhos' preparedness. we evaluated the construct validity with efa in spss v. software and cfa in mplus software (muthén and muthén, los angeles, california, usa). fitting indexes included comparative fit index (cfi), tucker-lewis index comparative fit index (tli), root mean square error of approximation (rmsea) and weighted root mean square residual. cronbach's α was used to measure the internal consistency. at first, we obtained items. there were items in the planning field, items in the field of education and items under infrastructure. for each item, a range of four options was considered, including 'not done', 'due to review', 'planned but not implemented' and 'completely implemented'. in face validity, four items in the planning field, one item in the field of training and two items in the infrastructure field were omitted. after reviewing the questions, healthcare professionals who specialised in the field of disasters and emergencies inspected the qualitative content validity. following this, based on the comments, certain corrections were made regarding the wording and language used in the questionnaire. in quantitative content validity, based on the cvr and cvi indicators, items in the planning field, items in the field of training and items in the infrastructure field were open access deleted. finally, items remained for entry into the construct validity stage. efa and cfa about cbhos volunteered to participate in the study. the kaiser-meyer-olkin test for sampling adequacy was . . next, to determine if the correlation matrix had a significant difference with zero and factor analysis was justifiable or not, the bartlett test of sphericity was performed, which turned out to be χ and p< . . these values indicated that the factor analysis is justifiable based on the correlation matrix, and the items can be used for factor analysis. in this study, limiting the extracting factors by referring to the 'community preparedness' principle of the cdc guideline in the field of public health emergencies and applying varimax rotation, efa with three factors were performed. we considered an inflection point of . as the minimum factor load needed to maintain the items. thus, items without deletion were entered into the cfa stage. two questions of the planning field and one question of the infrastructure field were exchanged based on the rotation matrix and the loadings factor, which were conceptually meaningful. the questions in the table and and in table were those exchanged questions. all items in the training field remained in the factor structure according to factor loads (table ) . the three-factor model confirmed by deleting item in the substructure field based on cfa findings (table ) . table shows cfa fitting indexes. the cronbach's α in the planning, training and infrastructure field were . , . and . , respectively. the cronbach's α of the whole tool was . . scores showed that the reliability of the tool is acceptable. thirty-four cbhos completed the austin questionnaire, and the spearman correlation coefficient was . that mean the criterion validity of the tool is acceptable. in this study, a tool was developed to assess the preparedness of cbhos during biohazards. the researcher-made tool consisted of planning, training and infrastructure fields based on previous studies. after achieving face and content validity, cfa was used for the threefactor model fit. efa was also used to compare the items replaced in the proposed model. some studies noted that items with a factor load above . and even . were acceptable. therefore, in the cfa, a single item with factor load less than . was deleted. table shows that the rmsea value of the model is . . according to previous studies, if the rmsea is between . and . , the model is acceptable. the index of cfi and tli is more than . , which shows that the three-factor model is acceptable. hence, in this study, we used cfa to compare the model fit of our tool with the proposed structure of the hhs office of the aspr. the office has divided the functions of community preparedness into three categories as planning, training and skills, equipment and technology. however, in this research, the research team consented to use the term 'infrastructure' instead of 'equipment and technology'. according to a cross-sectional study, the most challenging aspect in implementing the capabilities of the cdc's guideline is training and planning, and % of failing is related to infrastructure field. evidence from a qualitative study shows that planning and training fields are the most significant challenges faced by health workers in response to hurricane sandy. another study showed '"community preparedness"' as the common standard in both the accreditation standards developed by public health accreditation board (phab) and the capabilities of cdc's guideline. therefore, strengthening all organisations in community-based preparedness can improve both accreditation standards and follow cdc guideline. also, the fields of training, planning and infrastructure are common in both the guideline and the accreditation standards. in this regard, the categorisation of cbhos' preparation activities in the three areas in our research is consistent with the study. importance of community partnerships in disasters has motivated researchers to develop various assessment tools for evaluating cbhos' preparedness. glik et al and clawson et al developed tools as an instrument monitoring collaboration between local health departments and cbos. however, they focused more on the duties of health departments in engaging cbos. austin et al showed that cbos' preparedness in earthquake needs seven clusters of assessment including internal training, external response, response capabilities, information collection and distribution to staff, preparation, building protection and supplies. moreover, baezconde et al assessed preparedness of non-governmental organisations (ngos) considering social and structural needs. socially, ngos have high 'social will' but little 'community readiness' to participate in emergencies. structurally, ngos' linkage to voluntary organisations and public health departments lack enough coordination. an assessment tool with biohazard approach for cbo' preparedness is rare in literature, and we have tried to fill this gap. the cbhos in iran conduct weekly meetings at the health departments of medical universities wherein their fields of cooperation are identified. the representatives of cbhos participate at these meetings, and health authorities discuss fields that health systems lack an adequate budget or cannot intervene due to legislation. thus, cbhos depending on their capabilities would offer their cooperation with the health system. the aforementioned meetings will be held more actively in times of disasters. the evaluation of these cbhos in iran in terms of their capacities, capabilities, strengths and weaknesses in the field of planning, training and infrastructure can be achieved using this assessment tool. therefore, the government departments that licensed cbhos could plan out the relevant training needed before biohazards and be aware of their capacities to use them in times of disasters or empower capacities for future actions. moreover, biological hazard is a threatening disaster in iran owing to the various cultural and religious mass gathering posing a high risk of occurrence, namely, the epidemic of influenza, hepatitis b and d, various types of haemorrhagic fevers and brucellosis. in response to these epidemics, iran has used many strategies to cope with them. these include recruiting a surveillance system with mandatory reports of particular disease according to the guidelines of the ministry of health, training health personnel to prevent transmission of the disease in the community especially the high-risk group, using mass media to persuade community involvement in preventing transmission, controlling the vectors by using pesticides, educating people with high-risk job due to exposure to the disease source, preventing high-risk people in participating in hajj (pilgrimage), mandatory vaccination if participating in certain religious occasions and educating hygiene habits like washing hands and using a mask in very crowded places. cbhos participate in these actives to serve their covered population. [ ] [ ] [ ] [ ] [ ] this tool can help them to assess their preparedness in biohazard and recognise the need of enhancing their capacity. limitations it was not possible to check the reliability through testretest due to the low participation of cbhos in the research. we will use some qualitative or mixed method studies to verify this tool in future. in comparison with the aspr guidelines, our findings might reflect some potential item limitations regarding to ambiguous translation and wording sentences that would make difficult to answer for participants. we collected data on cbhos through the ministry of health. we used creditable mathematic calculation based on mature model and revised by experts' opinion. besides, this tool is used to measure the preparedness of cbhos and their ability to participate in biohazard and identify their weaknesses. the tool could aid better understanding of the training and skills required for cbhos to participate during hazards. furthermore, cbos can use this tool to participate in drills and practices. finally, the preparedness tool can help cbos improve their planning, training and infrastructure. the authors will verify credibility and extend its usability to improve its quality continuously. facilitating partnerships with community-and faith-based organizations for disaster preparedness and response: results of a national survey of public health departments agility and discipline: critical success factors for disaster response public health systems: a social networks perspective crisis and emergency risk communication in a pandemic: a model for building capacity and resilience of minority communities planing to be prepared: an empirical examination of the role of voluntary organizations in county government emergency planning assessing city preparedness for a biological attack mass-fatality incident preparedness among faith-based organizations are community health centers prepared for bioterrorism? pandemic influenza a (h n ) infection among hajj pilgrims from southern iran: a real-time rt-pcr-based study a food poisoning outbreak by shigella boydii in kerman-iran prevention of pneumococcal infections during mass gathering titering of pandemic h n influenza virus hemagglutinin inhibition antibody in nonvaccinated pregnant women in shiraz, southern iran effectiveness of a primary health care program on urban and rural community disaster preparedness, islamic republic of iran: a community intervention trial iranian health houses open the door to primary care effectiveness of community participation in earthquake preparedness: a communitybased participatory intervention study of tehran assessing the effectiveness and feasibility of implementing mitigation measures for an influenza pandemic in remote and isolated first nations communities: a qualitative community-based participatory research approach sampling techniques principles of questionnaire design in medical science studies content validity and its estimation the content validity index: are you sure you know what's being reported? critique and recommendations validity and reliability of the instruments and types of measurments in health applied researches objectifying content validity: conducting a content validity study in social work research designing and determining psychometric properties of the domestic elder abuse questionnaire critical values for lawshe's content validity ratio: revisiting the original methods of calculation exploratory or confirmatory factor analysis? surviving the next disaster: assessing the preparedness of community-based organizations public health preparedness capabilities: national standards for state and local planning. in: services usdohah centers for disease control and prevention - health care preparedness and response capabilities in: (hhs) dohahs u.s.: office of the assistant secretary for preparedness and response healthcare preparedness capabilities: national guidance for healthcare system preparedness community health agency administrators' access to public health data for program planning, evaluation, and grant preparation reliability and validity of the assessment for disaster engagement with partners tool (adept) for local health departments structural equation modeling and regression: guidelines for research practice using multivariate statistics. th edn evaluating the use of exploratory factor analysis in psychological research comparative fit indexes in structural models progress in public health emergency preparedness-united states community assessment for public health emergency response (casper): an innovative emergency management tool in the united states new york state public health system response to hurricane sandy: lessons from the field. disaster med. public health prep accreditation and emergency preparedness: linkages and opportunities for leveraging the connections reliability and validity of the assessment for disaster engagement with partners tool (adept) for local health departments maximizing participation of hispanic community-based/non-governmental organizations (ngos) in emergency preparedness comparing the model of government support programs for specific patients in iran enhancing community based health programs in iran: a multi-objective location-allocation model molecular epidemiology of crimean-congo hemorrhagic fever virus genome isolated from ticks of hamadan province of iran prevalence of human influenza virus in iran: evidence from a systematic review and meta-analysis histological and serological epidemiology of hepatitis delta virus coinfection among patients with chronic active hepatitis b virus in razavi khorasan province, northeastern iran the epidemiology and trend of hepatitis c infection in hamadan province: west of iran epidemiology of q fever in iran: a systematic review and meta-analysis for estimating serological and molecular prevalence acknowledgements the authors would like to thank the members of the departments of health in disasters and emergencies in the medical university of isfahan and tehran for contributing helpful comments on developing a validated assessment tool. key: cord- -ehfum k authors: badrfam, rahim; zandifar, atefeh; arbabi, mohammad title: mental health of medical workers in covid- pandemic: restrictions and barriers date: - - journal: j res health sci doi: . /jrhs. . sha: doc_id: cord_uid: ehfum k nan the high transmission power and lethality of covid- disease have led to special attention to the disease and efforts to control it . on the other hand, the covid- pandemic put a wide range of psychological pressure on health care workers. problems such as depression, anxiety, insomnia, and distress have been reported in many cases . mental health problems related to health care professionals need proper and comprehensive management during the covid- pandemic . following the covid- pandemic, demand for health care staff has increased dramatically. given the need of society for their effective and permanent presence, it is very important to pay attention to their expected needs . exposure to physical and mental trauma, high work responsibilities, enduring the loss of patients and colleagues, and the risk of infection are examples of these difficult conditions. for this reason, in addition to facilitating certain conditions for them, as resources needed by society, psychological support for these people is also very important . identifying their mental health problems and addressing these potential problems is the first step regarding an effective intervention. however, there seems to be a serious limitation in the expression of these problems by health care staff . "in general, in any biological disaster, fear, uncertainty, and stigmatization themes are common and may act as a barrier to physical and mental health interventions" . we will face a group of personnel who, despite the risk of mental health problems or having some degree of these problems, do not try to improve their conditions. this can pose many challenges for both these individuals and the patients under their care and the related health systems. in a relatively similar experiment, in the context of sever acute respiratory syndrome (sars) epidemics, most staff members were very concerned on becoming infected, although they generally considered this risk to be part of their job situation. about % of patients with sars at that time were health care workers. on the other hand, about half of them experienced social stigmatization and even some of them were, in a way, rejected by the family . in another study followed by the sars epidemic, both groups of staff, with a history of sars and no history of sars, shared a common concern about infecting their families . although the group that had a history of sars, thought more about discrimination related to having sars and other health issues. they saw themselves as more vulnerable to social and occupational discrimination. they also showed a greater prevalence of bone pain, lethargy, and physical weakness, and in addition to attributing some of them to medication side effects, some of these conditions could be attributed to the psychological effects on patients' concerns. as such, there appear to be many barriers to mental health care for staff. different conditions may also lead to referrals to other medical specialties. in this regard, providing training and creating appropriate awareness of this group of personnel can play an effective role in addressing these issues. another important point in this regard is the need for trustworthy behavior and avoidance of denying facts. this can be seen in the sudden spread of covid- in some countries. as we have seen in the italian experience and historically, we have seen similar conditions during the h n flu pandemic , . having confidence in health policy makers can provide the conditions for the delivery of mental health problems without worries and provide the conditions for the improvement of the current situation. lack of trust can also lead to many concerns, such as feelings of worry about job stability and a lack of proper support. the combination of these issues can increase concerns about the expression of mental problems by staff. in addition, a very important point is that health care workers sometimes use maladaptive coping strategies . they may deny the matter or consider it insignificant. the use of methods such as self-blame and avoidance can be used by this group of personnel, which can be very worrying. in addition, many normal adaptive coping strategies, such as social self-efficacy is the other important point in this regard. defects in self-efficacy which seen among a group of medical workers can be related to the fear of getting sick, and in some of them, it has been associated with post-traumatic stress disorder . social support was directly related to self-efficacy and was negatively related to stress and anxiety among staff . in staff who lack proper social support, the risk of low selfefficacy is higher. these people are prone to mental health disorders. there are also concerns that they will not raise issues related to mental health . having the right social support and even using social campaigns at a higher level can be effective in this regard. health care providers, especially in the field of covid- pandemics, are at risk for mental health disorders and failure to follow up to manage possible disorders. in order to strive to achieve the right mental health and psychological well-being in health care personnel, especially in the context of chronic stress, it is important to pay attention to creating the right conditions at the individual and organizational levels. at the individual level, the use of appropriate coping methods such as problem-solving (in what is estimated to be the case under individual control), emotion-based coping (to reduce isolation and increase support), meaning-based coping (for unresolved issues and permanent distress) accompanied with organizational resilience such as material reserves, back up plans, succession plans and proper management can be effective . creating a sense of trust, by meeting the needs of staff for proper personal protection and job stability, is one of the most important ways to express and pursue treatment for possible mental health disorders. the elimination of stigmatization requires public awareness at the community level with the help of social communication tools and efforts to address it at the individual level . this also seems to be helpful to express freely the mental health problems of health care personnel. proper social support also plays an important role in this regard. neglected major causes of death much deadlier than covid- factors associated with mental health outcomes among health care workers exposed to coronavirus disease iranian mental health during the covid- epidemic caring for the psychological well-being of healthcare professionals in the covid- pandemic crisis covid- : protecting health-care workers mental health and a novel coronavirus ( -ncov) in china timely mental health care for the novel coronavirus outbreak is urgently needed risk perception and impact of severe acute respiratory syndrome (sars) on work and personal lives of healthcare workers in singapore what can we learn? med care fear of severe acute respiratory syndrome (sars) among health care workers trust is a key factor in the willingness of health professionals to work during the covid- outbreak: experience from the h n pandemic in japan facing covid- in italy-ethics, logistics, and therapeutics on the epidemic's front line the effects of social support on sleep quality of medical staff treating patients with coronavirus disease (covid- ) in january and february in china cultivate self-efficacy for personal and organizational effectiveness applying the lessons of sars to pandemic influenza: an evidence-based approach to mitigating the stress experienced by healthcare workers stigma over covid- ; new conception beyond individual sense the authors declare that there is no conflict of interest. key: cord- -p sq yg authors: bales, connie watkins; tumosa, nina title: minimizing the impact of complex emergencies on nutrition and geriatric health: planning for prevention is key date: - - journal: handbook of clinical nutrition and aging doi: . / - - - - _ sha: doc_id: cord_uid: p sq yg complex emergencies (ces) can occur anywhere and are defined as crisis situations that greatly elevate the risk to nutrition and overall health (morbidity and mortality) of older individuals in the affected area. in urban areas with high population densities and heavy reliance on power-driven devices for day-to-day survival, ces can precipitate a rapid deterioration of basic services that threatens nutritionally and medically vulnerable older adults. the major underlying threats to nutritional status for older adults during ces are food insecurity, inadequate social support, and lack of access to health services. the most effective strategy for coping with ces is to have detailed, individualized pre-event preparations. when a ce occurs, the immediate relief efforts focus on establishing access to food, safe water, and essential medical services. the most common issues impacting on the nutritional well-being of elderly persons are comprehensively addressed in the preceeding chapters of this edition of the handbook of clinical nutrition and aging. this chapter focuses on a different type of concern, one that can overshadow all other threats to health when a serious disaster strikes. that subject is the welfare of aged persons when catastrophic events pose a direct (or indirect) threat to nutrition and health ( , ) . while there is a large body of literature on the health impact of natural and man-made disasters (e.g., droughts, floods, military conflicts) and associated long-term food shortages in the third world, surprisingly little information is available about the short and intermediate-term consequences of emergency situations in developed countries. in these situations, high population densities and heavy reliance on power-driven devices for day-to-day survival (e.g., electrical power for mass transit, elevators to reach living quarters, medical devices, and refrigeration of foods and medicines) can accelerate the speed with which a catastrophic, health-threatening situation develops. in , the plight of the elderly evacuees from new orleans (pre-storm population approaching , ) following hurricane katrina provided a dramatic demonstration of how essential services can rapidly deteriorate in a well-developed, highly populated urban environment following a major disaster and place older individuals in eminent mortal danger. in order to lay the foundation for this discussion, we begin with some definitions (see table . ). while terms like ''disaster relief'' and ''humanitarian crisis'' may be any of a number of crisis situations that greatly elevate the health risk of individuals in the affected area; examples are natural disasters like floods and earthquakes; urban health emergencies like fires, epidemics, and blackouts; and terrorist acts like massive bombings or poisonings of food or water supplies. resolution of these emergencies requires collaboration between multiple groups. acute protein/calorie malnutrition (pcm) pcm or ''wasting'' is associated with recent rapid weight loss, i.e., as in emergency situations (as opposed to chronic malnutrition). chronic energy deficiency (ced) an intake of energy that is below the minimum requirement for a period of several months or years. in order to achieve energy steady state, the energy expenditure must drop to match the low intake, ultimately leading to underweight and low levels of physical activity. nutritional rehabilitation restoration of weight and healthy nutrition through the provision of appropriate foods based on established protocols. food rations a shelf-stable pre-packaged dry ration that meets minimum daily intake recommendations for calories and other nutrients. used to temporarily meet critical nutritional needs when food supply is inadequate. examples: meals ready to eat or mres ( , kcal) are often distributed in complex emergencies in the united states; general food rations or gfrs ( , kcal) are distributed in many countries in sub-saharan africa. (continued ) more familiar, the most broadly acceptable term for these threatening situations is ''complex emergency'' ( ) . complex emergencies (ces) can occur anywhere and are defined as any of a number of crisis situations that greatly elevate the risk to nutrition and overall health of individuals in the affected area. examples include natural disasters like floods and earthquakes, urban health emergencies like fires, epidemics and blackouts, and terrorist acts like massive bombings or poisonings of food or water supplies (see table . ). ces were originally associated with wars, genocide, and political strife, where innocent civilians were forced to endure loss of access to shelter, food, appropriate clothing, and timely medical care. such emergencies have traditionally been associated with populations in developing nations, not those in the so-called developed countries. however, with increasing a complementary ration to the general food ration is sometimes provided. typically, it consists of fresh fruit and vegetables, condiments, tea, etc. it is especially appropriate when the population of concern is completely reliant on food assistance. ''wet'' feeding food rations prepared and cooked on-site as opposed to rations that are taken home for preparation in the household (dry rations). typically, fortified foods have had supplemental vitamins and/or minerals added. hunger the uneasy or painful sensation caused by lack of food. malnutrition the medical condition caused by an improper or insufficient diet that can refer to undernutrition resulting from inadequate consumption, poor absorption, or excessive loss of nutrients. malnutrition results from an inappropriate amount or quality of nutrient intake over a long period of time. the inability to obtain nutritionally adequate and safe food; or the inability to obtain it in socially acceptable ways food insufficiency inadequate amount of food intake due to a lack of food. epidemics and pandemics an epidemic is a disease outbreak that affects numbers of the population in excess of what would normally be expected in a defined community, geographical area, or season. a pandemic refers to this type of disease outbreak that is occurring over a wide geographic area and affecting an exceptionally high proportion of the population. source: borrel, a. addressing the nutritional needs of older people in emergency situations in africa: ideas for action. helpage international africa regional development centre, westlands, nairobi, . globalization of the world's societies and economies and news coverage documenting world events, it has become clear that ces can and do occur in both developed and developing world locations. nutritional risk is commonly elevated in ces and is most likely to occur when the crisis is protracted or recurrent. table . includes definitions for factors related to inadequate food intake (e.g., food insecurity, hunger), the resulting nutritional problems (e.g., malnutrition, acute protein/calorie malnutrition), and terms used to discuss interventions for undernutrition (e.g., food rations, nutritional rehabilitation). even in the absence of a crisis, older persons are well recognized to be at greater risk than the remainder of the adult population for food insecurity and hunger. some of the many factors that contribute to increased nutritional vulnerability of older adults are listed in table . . in , food insecurity and hunger affected at least . million households in the united states that contained older members ( ) . people in % of those households also experienced hunger, in addition to food insecurity. most of these older persons are suffering from food insecurity due to lack of income or due to their place of residence. residents of the south are more apt to experience food insecurity, as are residents of cities and all elders who live alone ( ). recognizing the day-to-day nutritional vulnerability of its poor and elderly citizens, the u.s. government has a number of programs in place to provide assistance to elders at risk for food insecurity and hunger. mandated by the older american's act, the elderly nutrition program (enp) provides a minimum of onethird of the daily calories required by recipients through daily meals and nutrition services to people aged or older in group settings, such as senior centers and churches, or in the home, through home-delivered meals. the enp provides an average of million meals per day to older americans. these meals are targeted toward highly vulnerable elderly populations, including the very old, people living alone, people below or near the poverty line, minority populations, and individuals with significant health conditions or physical or mental impairments. on an average the meals generously meet the rda requirements, supplying more than % of the recommended dietary allowances (rdas) for key nutrients, thus significantly increasing the dietary intakes of enp participants. the meals are also ''nutrient dense'', that is, they provide high ratios of key nutrients per calories. the most recent evaluation of the enp program occurred in and was conducted by mathematica policy research, inc. (www.mathematica-mpr.com/nutrition/ enp.asp). the resulting report clearly confirms that the enp program recipients are at nutritional risk. it was found that between and % of participants had incomes below % of the poverty level (twice the rate for the overall elderly population in the united states). more than twice as many title iii participants lived alone, compared with the overall elderly population. approximately, twothirds of the participants were either overweight or underweight, placing them at increased risk for nutrition and health problems. title iii home-delivered participants had more than twice as many physical impairments, compared with the overall elderly population. although (and perhaps because) the success of the enp program is well recognized, % of title iii enp service providers have waiting lists for home-delivered meals, suggesting a significant unmet need for these meals. it would appear that even in times of relative calm and prosperity for most americans, there are elderly citizens who are persistently in a state of nutritional crisis. when nutritionally and medically vulnerable older persons encounter a complex emergency, there is an increase in morbidity and mortality rates. this is due to both short-term insufficient nutrition and the resulting long-term increased mental stress and disability, decreased resistance to infection, and exacerbation of chronic diseases ( ), all of which make obtaining proper nutrition more difficult in a cyclic pattern. many different types of ces produce similar challenges. the consequences of a shortage of edible food and/or potable water, regardless of the type of emergency that produced that shortage, are multifold and can lead to increased physical and mental harm to older people ( ) . reduced access to essential medical care heightens the immediate risk. a more extensive listing of the immediate impact of various complex emergencies and the resulting nutritional and health consequences is shown in table . . the likelihood of having to provide care for older persons during a ce is greater than one might think at first. as previously noted, table . provides a list of common ces that have the potential to cause nutrition-related health risks. the impact of these crises on the nutritional state and overall health of older adults is discussed in more detail in the following sections. the hurricane season in the united states, most notably hurricanes rita and katrina, left no doubt that older persons continue to be disproportionately affected by hurricanes ( , ) just as they were with hurricane andrew in ( ). older floridians who were affected by hurricane charley in found that the hurricane not only disrupted their quality of life but also disrupted their medical care ( ) . persons with pre-existing conditions such as diabetes mellitus, heart disease, and physical disabilities were especially affected. approximately onethird of the older residents in the area had a worsening of their conditions posthurricane, including a lack of access to prescription medicine and loss of routine medical care for pre-existing conditions. medically related deaths were linked to the loss of power (resulting in loss of access to oxygen) and to exacerbation of cardiac disease. hurricane iniki in hawaii and the great hanshin-awaji earthquake in japan were associated with an increase in the rate of diabetes mellitus-associated deaths for a year following the disaster ( , ) . in a study of residents in the high-impact area of hurricane andrew, one-third of persons had high levels of ptsd ( ) , which was attributed to variables such as property damage, exposure to life-threatening situations, and injury. tornadoes, while typically more limited in the size of the area affected than a hurricane, are often even more physically destructive. although no research has been published on their specific effects on physical and mental health, it is well recognized that tornadoes can lead to many of the same dangers noted for hurricanes; the disruption of home care services and meal delivery to homebound elderly persons are of concern. the situation can become life threatening not only to the older persons who are critically dependent on these services but also to their dedicated care providers who often risk much to ensure the delivery of food and medical care to their clients (personal communication from area agency on aging of southwestern illinois grantees to nt). floods are a relatively common disaster and are often associated with earthquakes or hurricanes. besides trauma and drowning, the most common conditions associated with floods are an increase in gastrointestinal symptoms. increased preventable conditions following the crisis include gastroenteritis ( ), acute respiratory infections including asthma ( ), and increased post-traumatic stress which can persist for years after the event ( ). in the aftermath of an earthquake, as with the other natural disasters already mentioned, access to basic life-sustaining nutrients and hydration as well as to basic and specialized medical care may be partially or completely disrupted. due to the magnitude and scope of the destruction that occur with a major earthquake, the restoration of infrastructure to fully support the inhabitants of the region may take months or even years to be accomplished. earthquakes result in a three-fold increase in deaths from myocardial infarction, a doubling of the frequency of strokes, increased blood pressure levels, and increased coagulability of blood ( , ) . increased rates of cardiac arrests occurring after loss of power ( ) and deaths due to increased incidence of coronary heart disease ( ) and myocardial infarctions ( , ) are also reported. deterioration of mental health occurs and post-traumatic stress is also prevalent ( , ) . emotional stress can persist for months ( , ) . in particular, the displacement of elderly persons from their places of residence and their social and medical supports can have a dramatic negative effect on health and quality of life (see fig. . ). displacement following a ce has been linked with a significant increase in mortality rates ( , ) . the confusion of the displacement, as well as loss of access to appropriate diet and medications, prevents older individuals from monitoring and treating their medical conditions. inappropriate diet has been directly linked to decreased glycemic control and increased mortality in diabetic patients following an earthquake ( ). the type of naturally occurring ce that is most threatening for older persons in terms of numbers affected each year comes during periods of temperature extremes, especially heat waves, claiming about lives annually in the united states alone, more than the deaths caused by all other disasters combined. at greatest risk are poor persons who live in inner cities, those with chronic illnesses, and those homebound. heat disasters are often aggravated by power outages, which prevent people from keeping cool, bathing properly, and storing food at proper temperatures ( ) . in the heat wave in philadelphia, there was a % increase in total mortality, with a % increase in cardiovascular deaths, particularly in those persons over years of age ( ) . in france, during the period - , there were six major heat waves, resulting in thousands of deaths; the mortality ratios increased with age after years and in the over age years cohort; the death rate was higher for women than for men ( ) . although little research has been published about the health effects of ice storms and blizzards, the loss of power leaves older persons stranded at home, increasing the risk for ingestion of inadequate calories and inappropriately prepared food and/ or spoiled food. the risk of exposure combined with the risk of house fires or carbon monoxide poisoning due to use of unsafe heating devices pose serious threats at a time when emergency services may not available due to the extreme weather conditions. fires increase the extent of cardio-respiratory problems, which results in exacerbation of chronic diseases ( ) . people who already suffer from mental health problems or medically unexplained physical symptoms ( ) and gastrointestinal morbidity ( ) can develop an exacerbation of these problems ( , ) once they become a victim of a fire. even when no injuries result, fires almost certainly force displacement of their victims, adversely affecting quality of life and manifestation of chronic diseases. a serious infectious global pandemic is one of the most threatening of all complex emergencies, and calls back memories of the most devastating infectious disease outbreak on record, the great flu epidemic of - , which killed an estimated - million people worldwide. the spread of this epidemic was linked to the trans-global transportation of soldiers during world war i. today, world travel and the importation of foods and other products are very common. thus, in the event of a serious epidemic in one country, there is a high likelihood of quick transmission to others. the outbreak of sars, a severe acute respiratory illness caused by a coronavirus, was first reported in asia in february and spread to more than two dozen countries in north america, south america, europe, and asia (sickening , and killing ) before the global outbreak was contained (http://www.cdc.gov/ncidod/sars/factsheet.htm). in recognition of the severe strain that a major disease outbreak can place on health systems, the world health organization (who) advocates for an ''integrated global alert and response system for epidemics and other public health emergencies'' that allows for ''a collective approach to the prevention, detection, and timely response'' for these emergencies (http://www.who.int/csr/en/). the who is currently coordinating the global response to human cases of h n avian influenza (bird flu) with regards to the threat of a future influenza pandemic. a widespread illness or intoxication from a food source could also threaten nutritional and overall health. while these outbreaks are typically limited in scope and short lived, the potential for more widespread and dangerous effects exists due to the centralized nature of the us food distribution chain and the clustering of very large populations into a small geographical area. (see more on this topic in section . . . .) while other complex emergencies produce far more damage and deaths each year than are caused by terrorism, the destruction of the twin towers in new york city and a portion of the pentagon in washington dc on september , , focused the attention of americans upon the potentially devastating effects of an intentional man-made disaster. the development of the department of homeland security was a tangible product of the national response to implied threats of bio-terrorism. a terrorist attack such as one causing explosions and collapse of buildings would result in the interruption of basic living functions in a manner similar to previously discussed emergencies like earthquakes, tornadoes, or fires. disruptions to necessities of daily living and loss of power and access to medical care would be major concerns. a bioterrorist attack would have very different potential consequences for the well-being of the elderly, potentially causing widespread illness and/or hunger and dehydration. the propagation of an illness over a wide geographical area could be lethal for a substantial number of older adults, who are typically among the most medically vulnerable. during the anthrax attacks in , all emergent cases involved adults over years old, with the one fatal case affecting a -year-old woman ( ) . intentional contamination of food or water supplies with a toxin or infectious agent also has the potential to cause an outbreak of poisonings or illness over a wide geographical area. in this situation, the outbreak could be slow and/or diffuse and the cause difficult to ascertain, delaying the recognition and treatment of the problem. for example, in , bagged spinach contaminated (unintentionally) by escherichia coli infected over americans (killing three) in states before the strain was isolated and eradicated. similarly, intentional waterborne diseases or toxins would be difficult to detect and could impact a vulnerable population more severely than a healthy population, due to delayed recognition and reporting of the contamination ( ). in the case of deliberate food/water contamination, nutritional health is affected directly (by reducing the availability of safe food and water) as well as indirectly (by the symptoms of illness and the reduced access to an over-burdened medical care system). in fact, the deliberate poisoning of food has already occurred in the united states, when in members of the rajneesh religious cult contaminated salad bars in the dalles, oregon, with salmonella typhimurium. though it was only a trial run for a more extensive attack that was planned to disrupt local elections later that year, the contamination caused people to develop salmonellosis in a -week period. other isolated examples of intentional food contaminations have also been reported in the united states and canada ( ) . coping with complex emergencies due to terrorism is for the most part a new challenge, at least in the united states. despite considerable effort to prepare for these scenarios, our experience in dealing with the aftermath is limited, yet, unfortunately, our experience is likely to grow in the future. experts warn that a major terrorist attack on the united states is very likely ( - %) to occur within the next years (cfr online debate). heat, cold, hurricanes, tornadoes, floods, fires, illness, terrorism, and other disasters endanger health and claim elderly lives. sometimes the effects are immediate, but more often an increase in morbidity and mortality occurs progressively after the disaster as survivors experience a continued decrease in the quality of life and increased nutritional risk due to displacement and a loss of basic resources. these events result in increased disability, which further impairs the ability of older persons to maintain access to safe food and water and sustain proper nutrition and hydration, and so the spiral continues downward. recovery from food insecurity and poor nutrition is more difficult for persons who are poor, socially isolated, cognitively impaired, and/or old. the more risk factors people possess, the faster their decline. all of the disasters described in this chapter threaten nutritional and metabolic health because they disrupt access to food, water, and vital medical treatment ( ) . older persons with pre-existing chronic conditions are particularly vulnerable to these disruptions. preparation for and resolution of the aftermath of these emergencies require collaboration between multiple stakeholders and takes time. there are no easy fixes to ces. the underlying causes of malnutrition in older adults during ces are ( ) insufficient household food security, ( ) inadequate social and care environments, and ( ) poor public health and inadequate health services ( ) . the basis for current governmental and humanitarian responses to nutritional crises builds on lessons learned in the earliest organized relief efforts (circa - ) . during the s, guidelines began to be published following experiences with relief efforts in places like biafra and ethiopia ( ). in the subsequent decades, the experiences of various crises have progressively shaped what are, today, the characteristic challenges, and avenues of support available to older adults who are caught in ce situations in any given country. with increasing recognition that the elderly are uniquely vulnerable to ces, efforts are underway to develop specific recommendations and resources for this population group. table . lists some of the resources available, along with web links. helpage international (www.helpage.org) is a global network of more than not-for-profit organizations in countries who are working for improvements in the lives of older people. this group has published a manual of guidelines for best practice during disasters and humanitarian crises (see table . ). the sphere project minimum standards in disaster response project (http://www. sphereproject.org/content/view/ / ) advocates for the use of community-based systems to implement the care of older individuals in these circumstances. in the united states, a number of national organizations, including the federal emergency management agency (fema), the american red cross, and various branches of the military take responsibility for rescue and relief efforts following a major ce but the contribution of the private sector to the relief effort is traditionally also a substantial one. this type of broad-based support is necessary but makes it more difficult to consistently implement age-related guidelines for relief efforts once they are in the field. coordinating the advance preparation efforts for ces, however, is a more tangible goal. as is true for almost all health issues, the best way to address the nutritional and related health risks that accompany ces is to take preventive measures. in the case of nursing homes and assisted living facilities, many states require that these institutions have a substantial reserve food and water supply and that they have a welldelineated disaster and evacuation plan. the specifics of these requirements vary on a state-by-state basis. however, attention to the development of specialized parish, louisiana, due to a failure to comply with evacuation orders during hurricane katrina, and the bus accident in which houston, texas, nursing home residents being evacuated from hurricane rita died in a fire that was sparked by mechanical problems and fed by the explosions of the passengers' oxygen tanks. beyond the obvious need for institutions and organizations like long-term care and hospice agencies to have detailed plans for evacuations and emergency conditions, there is also a need to identify ''at risk'' older adults living in the community. this would involve developing registries of ''vulnerable populations'' of elders based on degree of factors like contact need, predominant special impairment, and predominant life-support supply need, if any. by doing so, vulnerable elders could be easily identified in the event of a disaster and better supplied with assistance. such registries are currently implemented in some instances (examples are available in california, www.aging.ca.gov, and florida, www.broward.org/atrisk), but a more systematic approach has yet to be employed. these registries will most likely need to be local in origin and maintenance in order that control of sensitive health data would remain confidential. however, it would be preferable for the structure of the databases to be developed in a uniform format in order to facilitate the sharing of important data across local and regional entities. once successful programs and examples are created, their implementation by all interested parties should then be straightforward. emergencies require flexibility and the ability to survive changes in regular routines. this flexibility can be easier to achieve if people have a few necessary and familiar objects with them to assist with performing certain everyday chores, such as eating properly, taking medications, and changing into clean clothes. in order to assist people in getting prepared for the disruptions that inevitably occur during an emergency, the fema and the american red cross recommend that every family have an emergency preparedness kit that contains food, water, clothing, medical supplies, flashlight, and other supplies that will aid their survival for - days. by the time recommended objects are placed in a backpack, the entire kit weighs between and pounds. this is clearly too much weight for an older person to handle safely. of emergency kits for elders the health resources and services administration (hrsa) provided funding to the gateway geriatric education center of missouri and illinois (grant number d hp ) for train-the-trainer programming to teach health-care professionals in the spring of how to create an emergency preparedness kit that was light, compact and specific for older adults. this kit consisted of a small satchel, a flashlight, a photo album (to store copies of prescriptions, insurance cards, evacuation plans, contact phone numbers, and family pictures), a pill box and a pamphlet introducing the fema web site. the trainees were then taught what other materials should be added to the kit to make it appropriate for a particular individual (table . ). upon completion of this training each of the trainees received two complete kits, one to use as an example during their subsequent training sessions of other health-care providers and the other to be given to a disadvantaged older person whom they deemed at risk during an emergency. each participant provided an e-mail address in order to be contacted year following their training to determine the outcomes of their training. one year after training, the trainees were contacted by e-mail. twenty-three of the e-mail addresses were no longer valid. of the remaining trainees, filled out and returned the survey within weeks ( % response rate). an additional surveys were returned after a second e-mail blast ( / , for a final response rate of %). the survey asked if, as a result of their training, had the trainees: . given the extra kit to an older adult? . determined if that kit had been used during an emergency? . used their own emergency kits for training, and if not, why? . used their own emergency kits during an emergency? responses to the quality improvement survey are summarized in table . . the majority of the trainees ( %) had given the extra kit to an older person and many ( ) ( ) of the respondents indicated that the person was either an older relative or a neighbor. however, few respondents ( %) had provided any training to other health-care providers on how to create these kits. barriers cited included lack of money to purchase kit contents, lack of commitment or permission from supervisors, lack of time to provide the training, and lack of time for their colleagues to receive training. the percentage of older adults that were reported to have used their emergency kits by the time of the end point survey was higher than expected ( %), especially given that only % of the (younger) trainees reported using their kits. however, a review of the disruptive weather patterns in the counties in eastern missouri and southwestern illinois where the trainees (and therefore, presumably of the older adults receiving the extra kits) lived, indicated that three area-wide power outages had occurred between august and january . all of these three power failures lasted - weeks, with the rural areas in southwestern illinois being the last to get power restored each time. each of these power failures affected at least a half million citizens each time. numerous cooling or heating stations were set up for older adults, thereby allowing them to evacuate from their homes during the days in august and to receive warm meals during the november and january power failures. multiple public service announcements encouraged people to evacuate their homes completely until power was restored, so many older adults either moved in with relatives who did have power or went to hotels. under those conditions, it is reasonable to expect older persons to take their emergency kits with them. many of the health-care provider trainees reported that they had gone to work daily. a brief second query to trainees who had used their kits and trainees who had not used their kits indicated that both sets had gone to work daily and returned home at night, even if they had no power at home. (these health-care providers worked in facilities with working generators.) several of those that took their kits with them indicated that the kits provided them with some measure of safety while traveling icy roads in november and january. those that had not used their kits indicated no perceived change in their normal safety. this quality improvement study shows that emergency kits for older adults are used during an emergency. community-dwelling older adults appear to be more vulnerable to weather emergencies than are the health-care providers who care for them, as evidenced by the differences in usage rates of the kits by both groups through three lengthy power outages. upon review of the barriers that prevented trainees from providing training to other health-care providers, it is possible that it would have been more appropriate to provide train-the-trainer programs to older adults rather than to health-care providers. peer-to-peer training might have had the added advantage of motivating trainers to find community funding to make kits for distribution because of a greater perceived personal need for the kits. because every emergency event presents a unique challenge, this section offers general information about coping with the major nutritional concerns, namely shortages of food and water and overall loss of access to social support and health-related resources. optimal public health and nutrition relief includes a broad range of interventions and needs to utilize strong programmatic interconnections to meet the aforementioned needs. in the immediate aftermath of a ce, the supplies of food and water may be extremely limited. in this event, food can be more safely rationed than water. a general guideline is that the minimum adult ration be one well-balanced meal per day, with the utilization of vitamin/mineral supplements, protein drinks, ''power bars'', or other fortified foods as meal extenders if available. however, water should not be rationed due to the very rapid effects of dehydration. individuals are advised to drink what is needed today and search for more water on a daily basis. indicators of dehydration in the elderly differ from those in younger individuals; increased thirst, reduced skin turgor are not reliable markers. better indicators include tongue dryness, longitudinal tongue furrows, dry mucous membranes of the nose and mouth, eyes that appear sunken, upper body weakness, speech difficulty, and confusion ( ) . when there is a loss of power to the home, perishable foods are to be consumed first, followed by foods from the freezer. frozen foods should be safe to eat for at least days following the power loss. at this point, nonperishable, staple foods would be the only safe source of nutrients. as conditions stabilize, food aid will begin to become available. the recommended actions to be facilitated for older adults include ( ) achieve/improve access to food aid (rations, supplemental feeding programs, etc.); ( ) ensure that the rations are easy to prepare and consume; and ( ) assure that the rations being used meet the nutritional requirements of older adults ( ) . the usda's food and nutrition service (fns) coordinates with state, local, and voluntary organizations to provide food for shelters and also distributes food packages and authorizes states to issue emergency food stamp benefits to individuals. as part of the national response plan, fns supplies food to disaster relief organizations such as the red cross and the salvation army for mass feeding or household distribution. these organizations, along with other private donors, support the supply of water and food rations to affected areas. there are several concerns related to the access and appropriateness of food aid for elderly individuals (again, see resources listed in table . ). access to the aid is a concern because disabilities and medical problems may prevent elderly individuals from reaching the distribution centers. another concern is the composition of the food rations, which may not be appropriate in consistency for persons who have dentures or who lack teeth and that may not be adequate in nutritional composition. food rations vary in composition; not all are developed for the primary purpose of post-ce relief. in the united states, the meal, ready-to-eat (mre), although first developed for use in the space program and now widely used by the armed forces, is one form of ration that is commonly distributed to civilians who need food following ces. having been designed for soldiers in a high activity situation, the mres are much higher in sodium ( , g) and fat ( g) than is optimal, especially for older adults ( ) . likewise, the texture, packaging, and preparation of mres were not developed with the intention of use by older adults. in an effort to supplement the nutritional needs of elderly citizens and to meet federal recommendations for increased emergency preparedness, the administration on aging (aoa) sought and received special funding to provide shelf stable meals that could be delivered to participants of the home-delivered-meal programs. these meals, which have a shelf life of approximately months, are delivered with instructions to consume them during emergencies when regular home-delivered meal service is disrupted. the program is new so, to date, no evaluations have been done to determine what becomes of those meals (e.g., are they saved for emergencies or eaten to supplement other meals). no policy has been created to determine liability for any sickness caused by consumption of meals that are beyond their expiration date (personal communication from area agency on aging of southwestern illinois and the mideast area agency on aging to nt). obtaining adequate food and water is only one step on the road to recovery where elderly persons are vulnerable to food insufficiency. once food is obtained it must then be stored properly, prepared properly, and then ingested without health risk. in each of these steps, older persons are also at increased risk, compared to the rest of the population. this is because these older persons have additional risk factors for poor nutrition such as functional impairments, social isolation, reduced ability to regulate energy intake, greater susceptibility to depression, decreased ability to taste and smell, poor dentition, and poor health. all of these items (listed in table . ) can lead to malnutrition, if not starvation, in older persons. following a ce, the speed with which basic services such as heating/cooling, shelter, and water supply can be restored will be a major factor in the recovery of older persons. past experience has shown that cold, loss of mobility, access to services, and psychological stress and trauma are some of the most important factors contributing to undernutrition in older people following a ce ( , ) . in particular, the loss of social networks and support systems increases the vulnerability of these individuals ( ) and needs to be corrected as soon as possible to prevent further deterioration as the days following the event go by. the best approach is to utilize programming strategies that address the needs of older adults without undermining their independence and discouraging their ability to support themselves ( , ) . the restoration of medical facilities and the provision of transportation to appropriate medical facilities in unaffected areas are not under the control of the individual clinician or caregiver. these efforts are usually dependent on the local police and military forces who take charge post-ce. additionally, medical facilities will vary in their ability to handle the ce, depending on the type of emergency. for example, the response to a ce such as a hurricane (which would probably slow down access to the facility) would be very different than that required for an infectious disease epidemic (when admissions might very quickly exceed capacity) ( ) . the challenge for the clinician on the front line is to stabilize the older patient until access to more formal support can be restored. thus, the aforementioned preparedness efforts are key in preventing the acceleration of medical conditions from chronic to life threatening. the availability of medical records and prescription medicines, as recommended for the evacuation kits of older adults, can play a critical role in this regard. in summary, the long list of complicated and threatening ces that can affect the nutritional status and overall medical welfare of older adults underscores the fact that all older adults and their care givers, as well as administrators of structured living facilities, should plan for and be physically and psychologically prepared for the event of a serious ce. . home-dwelling elders should be prepared for a ce by stocking a -week safety supply of food, water, and medications, having a carry-away disaster pack with medicines and other essential supplies, and having a delineated evacuation plan. . administrators/medical directors should ensure that nursing homes and assisted living facilities are prepared with food and water supplies and an alternate source of power and have detailed, individualized evacuation plans for each resident. ideally, a multidisciplinary team should utilize age-specific guidelines to design and implement a ce-preparedness plan. . in the future, there is a need for conceptual advances in understanding the causes of undernutrition in older adults during a ce and the development of better advance preparations and response mechanisms. the public health aspects of complex emergencies and refugee situations public nutrition in complex emergencies food security rates are high in elderly households hunger and food insecurity in the elderly food biosecurity morbidity surveillance after hurricane katrina -arkansas public health response to hurricanes katrina and rita -louisiana deaths related to hurricane andrew in florida 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the older community on awaji island. tsumna medical association heart attacks and the newcastle earthquake increased acute myocardial infarction mortality following the great hanshin-awaji earthquake in japan psychological impact of the hurricane mitch in nicaragua in a one-year perspective psychiatric morbidity and post-traumatic symptoms among survivors in the early stage following the earthquake in taiwan disaster severity and emotional disturbance: implications for primary mental health care in developing countries heat-related deaths -philadelphia and united states, - cardiovascular mortalitythe hidden peril of heat waves the impact of major heat waves on all-cause and cause-specific mortality in france from to cardiorespiratory hospitalizations associated with smoke exposure during the , southeast asian forest fires health problems presented in general practice by survivors before and after a fireworks disaster: associations with mental health care health problems of victims before and after disaster: a longitudinal study in general practice bioterrorism: from threat to reality water and bioterrorism: preparing for the potential threat to u.s. water supplies and public health threat of a biological terrorist attack on the us food supply: the cdc perspective public health issues in disasters clinical indicators of dehydration severity in elderly patients addressing the nutritional needs of older people in emergency situations in africa: ideas for action. westlands, nairobi, helpage international africa regional development centre military preventative medicine: mobilization and deployment. p. w. kelley, office of the surgeon general, department of the army nutritional risk factors for older refugees who is nutritionally vulnerable in bosnia-hercegovina? ageism: a factor in the nutritional vulnerability of older people? the initial hospital response to an epidemic identifying nutritionally vulnerable groups in case of emergencies: experience from the athens earthquake acknowledgments the authors thank caroline friedman for researching the historic and current events cited here. key: cord- -jkaxemmb authors: nakao, mutsuhiro; takeuchi, takeaki; he, peisen; ishikawa, hirono; kumano, hiroaki title: prevention and psychological intervention in depression and stress-related conditions date: journal: asian perspectives and evidence on health promotion and education doi: . / - - - - _ sha: doc_id: cord_uid: jkaxemmb this chapter focuses on depression and stress-related conditions to discuss possible strategies for the prevention or early management of such conditions. health education constitutes the first important strategy, and we outline a school-based educational activity using a case-method approach. we next illustrate the impact of stressful events on psychological health with the results of a survey among chinese individuals conducted after an unexpected epidemic of severe acute respiratory syndrome in . communication plays an important role in the assessment and management services provided by medical practitioners to sick individuals, with very diverse backgrounds and levels of medical knowledge, who consult health care providers with concerns about their health. in this context, we introduce a recent advance in patient–doctor communication. finally, we address the cognitive and behavioral features of those who suffer from depression and psychosocial stress. based on our recent activities and on evidence pertaining to health promotion and education, we emphasize the importance of health education and communication in the prevention of stress-related diseases and the promotion of physical and psychological health. depression constitutes one of the leading causes of disability in the world and is commonly encountered in primary care settings, in the workplace and school, and in the community. upon identification, depressed patients need appropriate management, including pharmacological treatment, sufficient rest, and social support. enlisting the cooperation of psychological professionals, such as registered psychologists, constitutes an important approach to providing psychological support for depressed patients. commonly used guidelines and educational programs are also effective in preventing depression and suicide-related health problems. depression clearly plays an important role in the epidemiology of suicide [ ] ; more than % of the individuals who commit suicide are depressed, and identifying individuals at high risk for depression might reduce the number of suicide attempts. the incidence of depression has increased rapidly in western countries, and the number of japanese individuals diagnosed with this condition has also increased, from ( . per ) to ( . per ), between and . these data may reflect increased use of a standardized method for diagnosing depression, such as the diagnostic and statistical manual of mental disorders, or they may relate to decreased resistance among those suffering from mind/body distress to visiting a psychiatrist. although depression is generally more common in women than in men, the most dramatic increase in the rate of depression in japan occurred among middle-aged men ( - years old); a similar trend was observed among those who committed suicide. an analysis of the relationship between six categories of occupational status and suicide revealed that suicide rates were the highest among the "unemployed" and "employee" groups. therefore, it is important to target middle-aged employees and unemployed people to identify potentially depressed individuals in japan. if all japanese people over years of age completed a questionnaire asking whether they experienced stress in their daily lives, more than % would respond "yes, i experience stress!" [ ] . this is the current situation in japan. illness can result when stressors are too intense and persistent or when specific individuals are vulnerable to particular stressors due to temperamental and/or adaptive problems. psychosocial stress is closely related to mind/body symptoms, and our own study has shown that the report of somatic symptoms is a good predictor of depression and such depression-related symptoms as suicidal ideation among both the disabled and working populations. it is vital to remember that the mind and body are inter-related. modern medicine tends to focus on somatic conditions, but such conditions represent only a part of the whole. medicine should not be limited to the treatment of disease; it is also important to prevent disease, whether at the tertiary or secondary level. the practice of medicine in a hospital requires a trusting relationship between patient and doctor, and both must be aware of the power of the mind-body connection. communication is a key factor in developing this relationship. although medical practitioners are busy and often do not nurture trusting relationships, such relationships are nonetheless a key component of mind/body medicine. effective communication helps promote patient satisfaction and makes a good physician better; however, a sound education, one that includes attendance at lectures and participation in simulations or hands-on training, is critical for the development of excellent physicians. this chapter focuses on depression and stress-related conditions with a view to developing a preventive strategy in association with health education. we have been developing a case-method teaching approach for japanese medical schools, and these recent activities are described in detail. we also present data from a chinese study assessing the impact of stressful events on psychological health. these data underscore the important role played by communication in the assessment and management services provided by medical practitioners to sick individuals, with very diverse backgrounds and levels of medical knowledge, who consult health-care providers with concerns about their health. in this context, we introduce a recent advance in patient-doctor communication. finally, we address the cognitive and behavioral features of those who suffer from depression and psychosocial stress. epidemic in japan an effective suicide prevention strategy should target potentially depressed students, because most individuals who commit suicide suffer from depression [ ] . education about depression and related matters during school may be an effective method for preventing suicide among students in japan. existing teaching styles, however, are ill-suited to address issues related to suicidal depression, due to the complex nature of this condition. extant teaching styles tend to rely on general content and to omit vivid descriptions. we introduce and discuss the applicability of a case-method teaching approach to issues related to suicide and depression in japan, and propose that this method replace traditional pedagogical approaches to these topics. we also refer to the case-method style used at harvard university. case-method teaching is a practical approach to training in the field of social medicine [ ] . this approach involves discussions about a particular case; participating doctors are taught how to deal with situations in which they must reach decisions about public health. the disease-oriented system (dos) has formed the basis of traditional educational systems, adhering to traditional medical teaching methods. although the dos seems to be an effective and reasonable method for obtaining results; it is neither perfect nor optimal in terms of practicality. the problem-based learning (pbl) method was developed to overcome these limitations in the dos method. medical treatment is incomplete when the individual is considered in isolation. indeed, we must consider various ambient and interactive environmental factors in order to adequately understand the etiology of, and recovery from, a disease. in other words, although we emphasize treating the patients and not the diseases, we do not provide our medical students with the practical training required to achieve this goal. figure visually represents the case-method concept, illustrating a more systematic and holistic approach to medicine, in which the scope of learningwhich proceeds through discussion -is wider than that of dos or pbl. through such quasi experience-based studies, medical students can not only acquire knowledge and develop the desired professional attitudes and behaviors but can also come to learn about the psychological and social problems actually experienced by patients. thus, in a way that mimics medical practice, they will be trained to solve problems embedded in actual situations. in addition, the shift from passive to active learning should enhance other abilities, such as communication skills and the practice of continually updating knowledge about state-of-the-art medical technologies. the case-method approach also offers the advantage of using actual cases to learn about the multidimensional issues involved in various aspects of medical practice, such as drawing on knowledge as the basis of actions, understanding the backgrounds of patients, and maintaining awareness of personal motivations and ethical concerns. however, the case method also has its share of problems. table summarizes the advantages and disadvantages of the case-method approach. we now discuss strategies for dealing with these disadvantages. fig. the reach of the disease-oriented system (dos), problem-based learning (pbl), and case methods more broadly, we need to adopt procedures that enable the identification and measurement of problems, the analysis of key determinants, the development of intervention strategies, the selection of an optimal intervention strategy, and the evaluation of outcomes to solve public health problems involving depression or other mental illnesses. based on the need for these procedures, the proposed problem-solving paradigm includes the following phases: ( ) defining the problem, ( ) measuring its magnitude, ( ) understanding key determinants, ( ) developing prevention/intervention strategies, ( ) setting policy/priorities, ( ) identifying the best solution, and ( ) implementing and evaluating the solution. definitions of public health problems must include the characteristics of the target populations and the nature and extent of exposures. one must also be able to understand the issue from a historical perspective and to consider hypothetical situations, the magnitude of the problem, the limitations that constrain potential approaches, and the definitions of technical terms. the definitional process aims at sharpening the skills used to identify potential problems in society. the core issues in this phase involve who defines the problem and how the problem is contextualized in society. using a multidimensional framework, students sometimes define the problem by playing the role of each stakeholder. after the problem has been defined, it is imperative to measure its parameters. this requires access to biostatistics, vital statistics, and demographic data as well as the skills to store, process, manipulate, and report on such information. the magnitude of the problem must be measured in terms of questions such as "why it is a problem?" and "why and how should it be solved?" details about the problem -its prevalence, incidence, economic impact, and effect on human beings -should also be evaluated and measured. further, the measurements need to be performed with reference to an index identified in the definition of the problem. once the problem has been defined and quantified, decisions about addressing it must be made. at this point, it becomes important to understand the key determinants of the problem, such as those related to its biological etiology (host, agent, and vector), its environmental impact, and the sociocultural/behavioral practices of the at-risk population. this step involves understanding the natural history of the disease process and identifying risk factors and at-risk populations. in the context of a clear understanding of the determinants of the public health problem, a number of alternative interventions can be proposed at the cellular/ microbial, individual, familial, communal, and/or population levels. once a wide range of alternatives is identified and the relative merits of each are considered, policies pertaining to a variety of communication, leadership, management, ethical, and financial issues must be developed. after prioritizing the possible solutions, it is necessary to identify the most appropriate one, on the basis of evidence and sound reasoning. these processes involve not only selecting but also directing and establishing possible policies for actual situations. when planners consider all strategies and focus on numerous possible results, decision making can be expedited by relying on such information. after development, the policy must be implemented and evaluated using most of the same quantitative and analytic skills used in the problem-definition and measurement phases. case-method teaching has been practiced at several universities for many years in a subset of courses, generally in the management area. many other courses have used short cases as vignettes or examples of a principle or concept that an instructor wishes to illustrate; however, few nonmanagement courses have used cases as a vehicle for learning through discussion and problem solving. as described by a "founding father" of the harvard business school method of using cases, "a good case is the vehicle by which a chunk of reality is brought into the classroom to be worked over by the class and the instructor." such cases generally do not have solutions but achieve their learning objectives by helping students develop their analytical skills through diagnosing problems and designing alternative solutions as well as by cultivating their decision-making and leadership abilities by allowing them to choose among alternatives and plan implementation strategies. three levels of teaching objectives are relevant to students who are also professionals: level one is the transmission of knowledge through information, concepts, • frameworks, tools, and techniques level two is the development of skills for analyzing, thinking critically, making • judgments and decisions, and executing decisions level three is the development of a professional identity and leadership capa-• bilities accompanied by a set of values, self-awareness, and a capacity for ongoing learning based on these different levels, we discuss the possibility of applying case-method teaching to education about depression and suicide that is designed to reduce the prevalence of suicide among the school-aged population. this section focuses on a study evaluating psychological responses to an actual stressful event. due to an unexpected epidemic of severe acute respiratory syndrome (sars) in china in [ ] , the chinese government and people became aware of the huge impact and destructive power of a public health crisis. in particular, this situation led to intense psychological responses and panic among the chinese people. we studied the psychological status of the population of china during the sars epidemic and analyzed the factors contributing to their responses to inform our efforts in health education and promotion. both quantitative and qualitative methods were adopted. the survey used stratified random sampling based on the severity of the epidemic to select beijing, taiyuan of shanxi province, and harbin of heilongjiang province as the sites for distributing the questionnaires developed by the authors. we also conducted in-person interviews with relevant department leaders. a total of completed questionnaires were received. analysis indicated that . % of the sample expressed some sort of abnormal psychological response. the area least affected by the epidemic, harbin, showed the lowest rate ( . %) of abnormal responses; this was followed by taiyuan city in shanxi province ( . %). beijing was characterized by the highest prevalence of abnormal responses ( . %). abnormally intense psychological responses were associated with the severity of the epidemic and were evidenced by experiences of nervousness, panic, lack of safety, upset, and anxiety (fig. ) . the major reasons behind these feelings included the sars epidemic itself, its mortality rate and unknown nature, the intense and anxious atmosphere created by responses to the epidemic, and the various rumors about the situation. among the most important contributors to these psychological abnormalities were delays in, and interference with, the operation of normal communications channels during the early days of the crisis, as well as the contradictory information emanating from various channels. the tasks involved in education about public health emergencies should not rest on the shoulders of public health education departments alone; instead, such work becomes the responsibility of society as a whole, and the government, mass media, and professional public health departments should play important roles in this process. the sars crisis had a widespread impact on the psychological well-being of the public. timely comprehension of the psychological state of the public and efficient intervention are absolutely necessary when public health emergencies arise. understanding how patients experience illness provides the basis for a therapeutic relationship between patient and physician. this is especially true in cases of patients with mind/body distress. it has long been acknowledged that patients and physicians tend to have different and sometimes conflicting views on health problems and on reasonable expectations for managing such problems. the perception of being understood by a physician provides emotional support for patients, especially at a time of great stress and vulnerability. communication is a major component of medical encounters and a fundamental means for the physician and patient to share perspectives. a growing body of evidence has linked effective communication not only to patient satisfaction and treatment adherence but also to health outcomes, including symptom resolution, functional status, physiological measures, and pain control. recent trends in japanese medicine have drawn increasing attention to the physician's ability to communicate with patients. communication skill is increasingly considered to be a core medical competency that can be taught and assessed in medical education rather than merely a personal trait associated with the physician. patient-physician communication has been studied intensively in western countries, and various instruments have been developed to objectively assess levels of communication in medical encounters. the roter interaction analysis system (rias) is one of the most widely used systems for assessing medical interactions. developed by debra roter, a professor at johns hopkins university, it has contributed to our understanding of the structure of communication in medical encounters and the link between communication and quality of care. the rias has several methodological strengths, and it has been used in many studies in many countries [ ] . the coding approach is tailored to the specific dyadic exchanges that occur in medical encounters. coding categories directly reflect the content and context of the routine dialogue between patients and physicians, including both task-focused and socio-emotional domains. identification and classification of verbal events are coded directly from videotapes or audiotapes, not from transcripts. coding software to help coders work directly from the audio/video data is also available. elimination of the resource-intensive effort necessary for an accurate and full transcription represents a practical advantage offered by the rias. in addition, because coding proceeds directly from video or audiotapes, it is possible to assess the tonal qualities of the interaction. furthermore, the validity and reliability of the rias have been assessed in previous studies, and both have been rated favorably in a comparison study. the list of rias-related studies is available from the rias website (http://riasworks.com). communication units are defined as "utterances," the smallest distinguishable speech segment to which a classification may be assigned. codes are assigned to each of these utterances. approximately mutually exclusive coding categories are used (table ) . table shows the results of an analysis of patient-physician communication occurring during cancer consultations in japan. the details of this study have been previously published [ ] [ ] [ ] . this analysis using the rias shows that a major part of the interactions involved information giving by both physician and patient. on the other hand, striking differences between physicians and patients emerged with respect to several categories. physicians asked nearly twice the number of questions, whereas patients produced twice as many positive utterances. the consultation was largely focused on biomedical topics, and the proportion of psychosocial exchanges was minimal. the regression analyses of patient satisfaction with respect to physician and patient communication behaviors, controlling for the identity of the physician and the characteristics of the patient and consultation [ ] [ ] [ ] , showed that a greater proportion of open-ended questions and a lower proportion of direction were associated with higher patient satisfaction. these communication styles have often been recommended to physicians for use in patient-centered consultations. on the other hand, the perceived emotional responsiveness of physicians was negatively associated with patient satisfaction. in this study, most of the utterances classified as physician emotional responsiveness were statements intended to reassure and encourage patients, such as "there is no need to worry" or "you will be all right." these data suggest that reassurance and encouragement might differ in essential ways from empathy and acceptance. that is, encouraging statements, especially when offered early in the presentation of patient complaints, may function as interruptions, preventing patients from fully describing their concerns. it is also possible that patients felt that they were expected to respond to reassurance from physicians by concluding their remarks even if they still had something to say. among the patient communication behaviors, question asking was associated with lower levels of satisfaction, possibly because the information needs of patients increase when the information provided by physicians is not sufficient or comprehensible. this may lead to greater question asking and lower satisfaction with the consultation. thus, patient question asking might express patient dissatisfaction. although the previous section described the use of the rias in research settings, the rias has also been used as an educational tool. indeed, this measure can be used for individual feedback in that it offers an objective assessment of communications. it also helps in understanding the structure of the entire communication as well as the function of each communication in medical encounters. further, it provides specific examples of each communication category, offering many ways to facilitate talking by patients, demonstrating empathy, and so on. in relation to medical education, further research is needed to explore when and how the key communication skills identified in communication research should be taught as well as to assess whether these skills can be learned. the ways in which patient-centered attitudes and communication skills can be developed and sustained by practitioners all along the continuum of health-care professionals should also be considered. although research in japan remains limited, previous studies have provided evidence that communication in medical encounters can have a significant impact on patient behaviors and outcomes. further research into patient-physician communication is needed to implement patient-centered care in the social and cultural context of japan. depressed individuals think negative, painful, and discouraging thoughts, such as "i am worthless," "i have no hope," and "i will fail again." they tend to think in irrational black-and-white, all-or-nothing terms such as, "if i make a mistake on this project, my career will end." cognitive therapy, developed by beck and colleagues, capitalizes on this facet of depressive syndromes to alleviate symptoms. numerous randomized controlled trials attest to the efficacy of cognitive therapy, which is often combined with behavioral techniques to constitute cognitive behavior therapy (cbt). cbt is a widely used psychological treatment for depression, and we have performed cbt with a variety of patients for more than years [ , ] . cbt often proceeds on the basis of two kinds of assessment procedures, both of which are referred to as "abc analysis" (fig. ) . abc represents an activating event, a belief, and a consequence (including mood and behavior) according to the analysis depicted in the upper section, whereas it represents an antecedent, a behavior, and a consequence according to the analysis depicted in the lower section. the first abc analysis assumes that a distortion in information processing plays an important role in generating problematic emotions and behaviors. on the other hand, the second abc analysis assumes that the contingency connecting one's own behaviors to the responses of others or the self produces the problematic behaviors. our experiences with cbt have identified problems with using this approach to treat depression in japan and have underscored issues that require further consideration to improve the effectiveness of treatment offered in actual clinical settings. one of the major problems with using cbt to treat depression in japan is that attending psychiatrists and physicians do not have sufficient time to implement the treatment. therefore, collaboration with clinical psychologists will be necessary. however, most hospitals and clinics do not employ clinical psychologists with adequate training in using cbt to treat depression and/or in depression itself. thus, we must first establish a functional collaboration among psychiatrists, physicians, and clinical psychologists. thereafter, the following issues should be considered with respect to delivering the actual treatment: ( ) how to implement cbt in the process of the overall treatment, ( ) how to educate and motivate patients with respect to psychological concerns, ( ) how to use various worksheets or monitoring sheets, ( ) how to handle the variability in depressive moods, and ( ) how to terminate treatment and prevent relapse. although the cognitive restructuring component of cbt is easy to understand and is effective, it is not the only active ingredient in this treatment of depression. indeed, any workable treatment program should also include, at the very least, attempts at behavioral activation. various worksheets or monitoring sheets can be used to conduct cbt in japanese clinical settings with limited staff and time resources. the present chapter addressed the importance of prevention, especially with regard to communication and education, by focusing on recent epidemics of depression and stress-related conditions. the patient-doctor relationship is fundamental to the process of medical diagnosis, and effective communication among residents and specialists engaging in health promotion is also central to the maintenance of healthy lifestyles. knowledge of psychological techniques such as cbt is useful when communicating with depressed patients and with any individual experiencing negative mental states. medical education is also essential in providing adequate numbers of well-trained health care professionals who can assess and manage mental health conditions. the ottawa charter for health promotion, introduced by the world health organization in , declared that health promotion goes beyond health care. although further consideration is needed to end the debate pitting medical care against population-level preventive activities, it is clear that health must appear on the agendas of policy makers at every level of government to facilitate awareness of the health consequences of a wide range of decisions [ ] . the responsibility for health promotion should be shared among individuals, community groups, and health professionals, as well as health service institutions and appropriate governmental agencies. we will continue our clinical and research activities in the service of promoting mental health in japan, china, asia, and throughout the world. the suicide epidemic in japan and strategies of depression screening for its prevention the healthy hospital: maximizing the satisfaction of patients, health workers, and the community a proposed approach to suicide prevention in japan: the use of self-perceived symptoms as indicators of depression and suicidal ideation the healthy hospital: maximizing the satisfaction of patients, health workers, and the community awareness of sars and public health emergencies among general publics (in chinese) the roter interaction analysis system (rias): utility and flexibility for analysis of medical interactions physician-patient communication and patient satisfaction in japanese cancer consultations the interaction between physician and patient communication behaviors in japanese cancer consultations and the influence of personal and consultation characteristics the healthy hospital: maximizing the satisfaction of patients, health workers, and the community changes in cerebral glucose utilization in patients with panic disorder treated with cognitive-behavioral therapy treatment of psychosomatic illness: cognitive behavioral therapy the healthy hospital: maximizing the satisfaction of patients, health workers, and the community the content of the sections written by all five authors was based primarily on the symposium, "prevention and psychological intervention in depression and stress-related conditions," held at the first asia-pacific conference on health promotion and education, makuhari, japan, on july , . in addition, the content of the section authored by drs nakao, takeuchi, and ishikawa was partially based on the th teikyo-harvard symposium, itabashi, japan, on june , . key: cord- -tpqsjjet authors: nan title: section ii: poster sessions date: - - journal: j urban health doi: . /jurban/jti sha: doc_id: cord_uid: tpqsjjet nan food and nutrition programs in large urban areas have not traditionally followed a systems approach towards mitigating food related health issues, and instead have relied upon specific issue interventions char deal with downstream indicators of illness and disease. in june of , the san francisco food alliance, a group of city agencies, community based organizations and residents, initiated a collahorarive indicator project called rhe san francisco food and agriculture assessment. in order to attend to root causes of food related illnesses and diseases, the purpose of the assessment is to provide a holistic, systemic view of san francisco\'s food system with a focus on three main areas that have a profound affect on urban public health: food assistance, urban agriculture, and food retailing. using participatory, consensus methods, the san francisco food alliance jointly developed a sec of indicators to assess the state of the local food system and co set benchmarks for future analysis. members collected data from various city and stare departments as well as community based organizations. through the use of geographic information systems software, a series of maps were created to illustrate the assets and limitations within the food system in different neighborhoods and throughout the city as a whole. this participatory assessment process illustrates how to more effectively attend to structural food systems issues in large urban areas by ( t) focusing on prevention rather than crisis management, ( ) emphasizing collaboration to ensure institutional and structural changes, and ( ) aptly translating data into meaningful community driven prevention activities. to ~xplore the strategies to overcome barriers to population sample, we examined the data from three rapid surveys conducted at los angeles county (lac). the surveys were community-based partic· patory surveys utilizing a modified two-stage cluster survey method. the field modifications of the method resulted in better design effect than conventional cluster sample survey (design effect dose to that if the survey was done as simple random sample survey of the same size). the surveys were con· ducte~ among parents of hispanic and african american children in lac. geographic area was selected and d .v ded int.o small c~usters. in the first stage, clusters were selected with probability proportionate to estimated size of children from the census data. these clusters were enumerated to identify and develop a list of households with eligible children from where a random sample was withdrawn. data collectmn for consented respondents involved - minutes in-home interview and abstraction of infor· ma~ion from vaccine record card. the survey staff had implemented community outreach activities designed to fost~r an~ maintain community trust and cooperation. the successful strategies included: developing re.lat on .w. th local community organizations; recruitment of community personnel and pro· vide them with training to conduct the enumeration and interview; teaming the trained community introduction: though much research has been done on the health and social benefits of pet ownership for many groups, there have been no explorations of what pet ownership can mean to adults who are marginalized, living on fixed incomes or on the street in canada. we are a community group of researchers from downtown toronto. made up of front line staff and community members, we believe that community research is important so that our concerns, visions, views and values are presented by us. we also believe that research can and should lead to social change. method: using qualitative and exploratory methods, we have investigated how pet ownership enriched and challenged the lives of homeless and transitionally housed people. our research team photographed and conducted one-on-one interviews with pet owners who have experienced home· lessncss and live on fixed incomes. we had community participation in the research through a partnership with the fred vicror centre camera club. many of the fred victor centre camera club members have experienced homelessness and being marginalized because of poverty. the members of the dub took the photos and assisted in developing the photos. they also participated in the presenta· tion of our project. results: we found that pet ownership brings important health and social benefits to our partici· pants. in one of the most poignant statements, one participant said that pet ownership " ... stops you from being invisible." another commented that "well, he taught me to slow down, cut down the heavy drugs .. " we also found that pet ownership brings challenges that can at times be difficult when one is liv· ing on a fixed income. we found that the most difficult thing for most of the pet owners was finding affordable vet care for their animals. conclusion: as a group, we decided that research should only be done if we try to make some cha.nges about what we have learned. we continue the project through exploring means of affecting social change--for example, ~eti.tions and informing others about the result of our project. we would like to present our ~mdmgs and experience with community-based participatory action resea.rch m an oral. presentarton at yo~r conference in october. our presentation will include com· mumty representation ~f. both front-hne staff and people with lived experience of marginalization and homdessness. if this is not accepted as an oral presentation, we are willing to present the project m poster format. introduction the concept of a healthy city was adopted by the world health organization some time ago and it includes strong support for local involvement in problem solving and implementation of solutions. while aimed at improving social, economic or environmental conditions in a given community, more significantly the process is considered to be a building block for poliq reform and larger scale 'hange, i.e. "acting locally while thinking globally." neighbourhood planning can he the entry point for citizens to hegin engaging with neighbours on issues of the greater common good. methods: this presentation will outline how two community driven projects have unfolded to address air pollution. the first was an uphill push to create bike lanes where car lanes previously existed and the second is an ongoing, multi-sectoral round table focused on pollution and planning. both dt•monstrate the importance of having support with the process and a health focus. borrowing from traditions of "technical aid"• and community development the health promoter /planner has incorporated a range of "determinants of health" into neighbourhood planning discussions. as in most urban conditions the physical environment is linked to a range of health stressors such as social isolation, crowding, noise, lack of open space /recreation, mobility and safety. however typical planning processes do not hring in a health perspective. health as a focus for neighbourhood planning is a powerful starti_ng point when discussing transportation planning or changing land-uses. by raising awareness on determmants of health, citizens can begin to better understand how to engage in a process and affect change. often local level politics are involved and citizens witness policy change in action. the environmental liaison committee and the dundas east hike lanes project resulted from local level initiatives aimed at finding solutions to air pollution -a priority identified hy the community. srchc supported the process with facilitation and technical aid. _the processs had tangible results that ultimately improve living conditions and health. •tn the united kmgdom plannm in the 's established "technical aid" offices much like our present day legal aid system to provide professional support and advocacy for communities undergoing change. p - (c) integrating community based research: the experience of street health, a community service agency i.aura cowan and jacqueline wood street health began offering services to homeless men and women in east downtown ~oronto in . nursing stations at drop-in centres and shelters were fo~lowed by hiv/aids prevent ~, harm reduction and mental health outreach, hepatitis c support, sleeping bag exchange, and personal tdennfication replacement and storage programs. as street health's progi;ams expanded, so to~ did the agency:s recognition that more nee~ed t~ be done to. address the underl~ing causes of, th~ soct~l and economic exclusion experienced by its clients. knowing t.h~t. a~voca~y ts. helped by . evtd~nce , street he.alt~ embarked on a community-based research (cbr) initiative to dent fy commumty-dnven research priorities within the homeless and underhoused population. methods: five focus groups were conducted with homeless people, asking participants to identify positive and negative forces in their lives, and which topics were important to take action on and learn more about. findings were validated through a validation meeting with participants. results: participants identified several important positive and negative forces in their lives. key positive forces included caring and respectful service delivery, hopefulness and peer networks. key negative forces included lack of access to adequate housing and income security, poor service delivery and negative perceptions of homeless people. five topics for future research emerged from the process, focusing on funding to address homelessness and housing; use of community services for homeless people; the daily survival needs of homeless people and barriers to transitioning out of homelessness; new approaches to service delivery that foster empowerment; and policy makers' understanding of poverty and homelessness. conclusions: although participants expressed numerous issues and provided much valuable insight, definitive research ideas and action areas were not clearly identified by participants. however, engagement in a cbr process led to some important lessons and benefits for street health. we learned that the community involvement of homeless people and front-line staff is critical to ensuring relevance and validity for a research project; that existing strong relationships with community parmers are essential to the successful implementation of a project involving marginalized groups; and that an action approach focusing on positive change can make research relevant to directly affected people and community agency staff. street health benefited from using a cbr approach, as the research process facilitated capacity building among staff and within the organization as a whole. p - (c) a collaborative process to achieve access to primary health care for black women and women of colour: a model of community based participartory research notisha massaquoi, charmaine williams, amoaba gooden, and tulika agerwal in the current healthcare environment, a significant number of black women and women of color face barriers to accessing effective, high quality services. research has identified several issues that contribute to decreased access to primary health care for this population however racism has emerged as an overarching determinant of health and healthcare access. this is further amplified by simultaneous membership in multiple groups that experience discrimination and barriers to healthcare for example those affected by sexism, homelessness, poverty, homophobia and heterosexism, disability and hiv infection. the collaborative process to achieve access to primary health care for black women and women of colour project was developed with the university of toronto faculty of social work and five community partners using a collaborative methodology to address a pressing need within the community ro increase access to primary health care for black women and women of colour. women's health in women's hands community health centre, sistering, parkdale community health centre, rexdale community health centre and planed parenthood of toronto developed this community-based participatory-action research project to collaboratively barriers affecting these women, and to develop a model of care that will increase their access to health services. this framework was developed using a process which ensured that community members from the target population and service providers working in multiculrural clinical settings, were a part of the research process. they were given the opportunity to shape the course of action, from the design of the project to the evaluation and dissemination phase. empowerment is a goal of the participatory action process, therefore, the research process has deliberately prioritized _ro enabling women to increase control over their health and well-being. in this session, the presenters will explore community-based participatory research and how such a model can be useful for understanding and contextualizing the experiences of black women and women of colour. they will address. the development and use of community parmerships, design and implementation of the research prorect, challenges encountered, lessons learnt and action outcomes. they will examine how the results from a collaborative community-based research project can be used as an action strategy to poster sessions v address che social determinants of women health. finally the session will provide tools for service providers and researchers to explore ways to increase partnerships and to integrate strategies to meet the needs of che target population who face multiple barriers to accessing services. lynn scruby and rachel rapaport beck the purpose of this project was ro bring traditionally disenfranchised winnipeg and surrounding area women into decision-making roles. the researchers have built upon the relationships and information gachered from a pilot project and enhanced the role of input from participants on their policy prioriries. the project is guided by an advisory committee consisting of program providers and community representatives, as well as the researchers. participants included program users at four family resource cencres, two in winnipeg and two located rurally, where they participated in focus groups. the participants answered a series of questions relating to their contact with government services and then provided inpuc as to their perceptions for needed changes within government policy. following data analysis, the researchers will return to the four centres to share the information and continue che discussion on methods for advocating for change. recommendations for program planning and policy development and implementation will be discussed and have relevance to all participants in the research program. women's health vera lefranc, louise hara, denise darrell, sonya boyce, and colleen reid women's experiences with paid and unpaid work, and with the formal and informal economies, have shifted over the last years. in british columbia, women's employability is affected by government legislation, federal and provincial policy changes, and local practices. two years ago we formed the coalition ior women's economic advancement to explore ways of dealing with women's worsening economic situations. since the formation of the coalition we have discussed the need for research into women's employabilicy and how women were coping and surviving. we also identified how the need to document the nature of women's employability and reliance on the informal economy bore significanc mechodological and ethical challenges. inherent in our approach is a social model of women's health that recognizes health as containing social, economic, and environmental determinants. we aim to examine the social contexc of women's healch by exploring and legitimizing women's own experiences, challenging medical dominance in understandings of health, and explaining women's health in terms of their subordination and marginalizacion. through using a feminist action research (far) methodology we will explore the relationship between women's employability and health in communities that represent bricish columbia's social, economic, cultural/ethnic, and geographic diversities: skidegate, fort st . .john, lumhy, and surrey. over the course of our year project, in each community we will establish and work with advisory committees, hire and train local researchers, conduct far (including a range of qualitative methods), and support action and advocacy. since the selected communities are diverse, the ways that the research unfolds will ·ary between communities. expected outcomes, such as the provision of a written report and resources, the establishment of a website for networking among the communities, and a video do.:umentary, are aimed at supporting the research participants, coalition members, and advisory conuniuces in their action efforts. p t (c) health & housing: assessing the impact of transitional housing for people living with hiv i aids currently, there is a dearth of available literature which examines supporrive housing for phas in the canadian context. using qualitative, one-on-one interviews we investigace the impact of transitional housing for phaswho have lived in the up to nine month long hastings program. our post<'r pr<·senta-t on will highlight research findings, as well as an examination of transitional housing and th<· imp;kt it has on the everyday lives of phas in canada. this research is one of two ground breaking undertakings within the province of ontario in which fife house is involved. p - (c) eating our way to justice: widening grassroots approaches to food security, the stop community food centre as a working model charles l.evkoe food hanks in north america have come co play a central role as the widespread response to growing rates of hunger. originally thought to be a short term-solution, over the last years, they have v poster sessions be · · · · d wi'thi'n society by filling the gaps in the social safety net while relieving govemcome mst tut ona ze . . . t f the ir responsibilities. dependent on corporate donations and sngmauzmg to users, food banks men so th' . · i i . are incapable of addressing the structural cause~ of ~u~ger. s pres~ntation w e~~ ore a ternanve approaches to addressing urban food security while bmldmg more sustamabl.e c~mmumt es. i:nrough the f t h st p community food centre, a toronto-based grassroots orgamzanon, a model is presented case e h'l k' b 'id · b that both responds to the emergency food needs of communities w e wor mg to. u ~ sustama le and just food system. termed, the community food centre model. (cfc), ~he s~op is worki?g to widen its approach to issues of food insecurity by combining respectful ~ rect service wit~ com~~mty ~evelop ment, social justice and environmental sustainability. through this approach, various critical discourses around hunger converge with different strategic and varied implications for a~ion. as a plac~-based organization, the stop is rooted within a geographical space and connected directly to a neighbourhood. through working to increase access to healthy food, it is active in maintaining people's dignity, building a strong and democratic community and educating for social change. connected to coalitions and alliances, the stop is also active in organizing across scales in connection with the global food justice movement. inner city shelter vicky stergiopoulos, carolyn dewa, katherine rouleau, shawn yoder, and lorne tugg introduction: in the city of toronto there are more than , hostel users each year, many with mental health and addiction issues. although shelters have responded in various ways to the health needs of their clients, evidence on the effectiveness of programs delivering mental health services to the home· less in canada has been scant. the objective of this community based research was to provide a forma· tive evaluation of a multi-agency collaborative care team providing comprehensive care for high needs clients at toronto's largest shelter for homeless men. methods: a logic model provided the framework for analysis. a chart review of clients referred over a nine month period was completed. demographic data were collected, and process and outcome indicators were identified for which data was obtained and analyzed. the two main outcome measures were mental status and housing status months after referral to the program. improvement or lack of improvement in mental status was established by chart review and team consensus. housing outcomes were determined by chart review and the hostel databases. results: of the clients referred % were single and % were unemployed. forty four percent had a psychiatric hospitalization within the previous two years. the prevalence of severe and persistent men· tal illness, alcohol and substance use disorders were %, % and % respectively. six months after referral to the program % of clients had improved mental status and % were housed. logistic regression controlling for the number of general practitioner and psychiatrist visits, presence of person· ality or substance use disorder and treatment non adherence identified two variables significantly associ· ated mental status improvement: the number of psychiatric visits (or, . ; % ci, . - . ) and treatment non adherence (or, . ; % ci, . - . ). the same two variables were associated with housing outcomes. history of forensic involvement, the presence of a personality or substance use disorder and the number of visits with a family physician were not significantly associated with either outcome. conclusions: despite the limitations in sample sire and study design, this study can yield useful informa· tion to program planners. our results suggest that strategies to improve treatment adherence and access to mental health specialists can improve outcomes for this population. although within primary care teams the appropriate collaborative care model for this population remains to be established, access to psychiatric follow up, in addition to psychiatric assessment services, may be an important component of a successful program. mount sinai hospital (msh) has become one of the pre-eminent hospitals in the world by contributing to the development of innovative approaches to effective health care and disease prevention. recently, the hospital has dedicated resources towards the development of a strategy aimed at enhancing the hospital's integration with its community partners. this approach will better serve the hospital in the current health care environment where local health integration networks have been struck to enhance and support local capacity to plan, coordinate and integrate service delivery. msh has had early success with developing partnerships. these alliances have been linked to programs serving key target populations with _estabhshe~. points of access to msh. recognizing the need to build upon these achievements to remain compe~mve, the hospital has developed a community integration strategy. at the forefront of this strategy is c.a.r.e (community advisory reference engine): the hospital's compendium of poster sessions v community partners. as a single point of access to community partner information, c.a.r.e. is more than a database. c.a.r.e. serves as the foundation for community-focused forecasting and a vehicle for inter and intra-organizational knowledge transfer. information gleaned from the catalog of community parmers can be used to prepare strategic, long-term partnership plans aimed at ensuring that a comprehensive array of services can be provided to the hospital community. c.a.r.e. also houses a permanent record of the hospital's alliances. this prevents administrative duplication and facilitates the formation of new alliances that best serve both the patient and the hospital. c.a.r.e. is not a stand-alone tool and is most powerful when combined with other aspects of the hospital's community integration strategy. it iscxpected that data from the hospital's community advisory committees and performance measurement department will also be stored alongside stakeholder details. this information can then be used to drive discussions at senior management and the board, ensuring congruence between stakeholder, patient and hospital objectives. the patient stands to benefit from this strategy. the unique, distinct point of reference to a wide array of community services provides case managers and discharge planners with the information they need to connect patients with appropriate community services. creating these linkages enhances the patient's capacity to convalesce in their homes or places of residence and fosters long-term connections to neighborhood supports. these connections can be used to assist with identifying patients' ongoing health care needs and potentially prevent readmission to hospital. introduction: recruiting high-risk drug users and sex workers for hiv-prevention research has often been hampered by limited access to hard to reach, socially stigmatized individuals. our recruitment effom have deployed ethnographic methodology to identify and target risk pockets. in particular, ethnographers have modeled their research on a street-outreach model, walking around with hiv-prevention materials and engaging in informal and structured conversations with local residents, and service providers, as well as self-identified drug users and sex workers. while such a methodology identifies people who feel comfortable engaging with outreach workers, it risks missing key connections with those who occupy the margins of even this marginal culture. methods: ethnographers formed a women's laundry group at a laundromat that had a central role as community switchboard and had previously functioned as a party location for the target population. the new manager helped the ethnographers invite women at high risk for hiv back into the space, this time as customers. during weekly laundry sessions, women initiated discussions about hiv-prevention, sexual health, and eventually, the vaccine research for which the center would be recruiting women. ra.its: the benefits of the group included reintroducing women to a familiar locale, this time as customers rather than unwelcome intruders; creating a span of time (wash and dry) to discuss issues important to me women and to gather data for future recruitment efforts; creating a location to meet women encountered during more traditional outreach research; establishing the site as a place for potential retention efforts; and supporting a local business. women who participated in the group completed a necessary household task while learning information that they could then bring back to the community, empowering them to be experts on hiv-prevention and vaccine research. some of these women now assist recruitment efforts. the challenges included keeping the group women-only, especially after lunch was provided, keeping the membership of the group focused on women at risk for hiv, and keeping the women in the group while they did their laundry. conclusion: public health educators and researchers can benefit from identifying alternate congregation sites within risk pockets to provide a comfortable space to discuss hiv prevention issues with high-risk community members. in our presentation, we will describe the context necessary for similar research, document the method's pitfalls and successes, and argue that the laundry group constitutes an ethical, respectful, community-based method for recruitment in an hiv-prevention vaccine trial. p - t (c) upgrading inner city infrastructure and services for improved environmental hygiene and health: a case of mirzapur in u.p. india madhusree mazumdar in urgency for agricultural and industrial progress to promote economic d.evelopment follo_wing independence, the government of india had neglected health promotion and given less emphasis on infrastructure to promote public health for enhanced human pro uct v_ity. ong wit r~p m astrucrure development, which has become essential if citie~ are to. act ~s harbmger.s of econ~nuc ~owth, especially after the adoption of the economic liberalization policy, importance _is a_lso ~emg g ve.n to foster environmental hygiene for preventive healthcare. the world health orga~ sat ~ is also trj:' ! g to help the government to build a lobby at the local level for the purpose by off~rmg to mrroduce_ its heal.thy city concept to improve public health conditions, so as to reduce th_e disease burden. this pape~ s a report of the efforts being made towards such a goal: the paper descr~bes ~ c~se study ?f ~ small city of india called mirzapur, located on the banks of the nver ganga, a ma or lifeline of india, m the eastern part of the state of uttar pradesh, where action for improvement began by building better sanitation and environmental infrastructure as per the ganga action plan, but continued with an effort to promote pre· ventive healthcare for overall social development through community participation in and around the city. asthma physician visits in toronto, canada tara burra, rahim moineddin, mohammad agha, and richard glazier introduction: air pollution and socio-economic status are both known to be associated with asthma in concentrated urban settings but little is known about the relationship between these factors. this study investigates socio-economic variation in ambulatory physician consultations for asthma and assesses possible effect modification of socio-economic status on the association between physician visits and ambient air pollution levels for children aged to and adults aged to in toronto, canada between and . methods: generalized additive models were used to estimate the adjusted relative risk of asthma physician visits associated with an interquartile range increase in sulphur dioxide, nitrogen dioxide, pm . , and ozone, respectively. results: a consistent socio-economic gradient in the number of physician visits was observed among children and adults and both sexes. positive associations between ambient concentrations of sul· phur dioxide, nitrogen dioxide and pm . and physician visits were observed across age and sex strata, whereas the associations with ozone were negative. the relative risk estimates for the low socio-«onomic group were not significantly greater than those for the high socio-economic group. conclusions: these findings suggest that increased ambulatory physician visits represent another component of the public health impact of exposure to urban air pollution. further, these results did not identify an age, sex, or socio-economic subgroup in which the association between physician visits and air pollution was significantly stronger than in any other population subgroup. eco-life-center (ela) in albania supports a holistic approach to justice, recognizing the environ· mental justice, social justice and economic justice depend upon and support each other. low income cit· izens and minorities suffer disproportionately from environmental hazards in the workplace, at home, and in their communities. inadequate laws, lax enforcement of existing environmental regulations, and ~ea.k penalties for infractions undermine environmental protection. in the last decade, the environmental ust ce m~ve~ent in tirana metropolis has provided a framework for identifying and exposing the links ~tween irrational development practices, disproportionate siting of toxic facilities, economic depres· s on, and a diminished quality of life in low-income communities and communities of color. the envi· ~onmental justice agenda has always been rooted in economic, racial, and social justice. tirana and the issues su.rroun~ing brow~fields redevelopment are crucial points of advocacy and activism for creating ~ubstantia~ social chan~~ m low-income communities and communities of color. we engaging intensively m prevcnnng co'.' mumnes, especially low income or minority communities, from being coerced by gov· ernmenta~ age_nc es or companies into siting hazardous materials, or accepting environmentally hazard· ous_ practices m order to create jobs. although environmental regulations do now exist to address the environmental, health, and social impacts of undesirable land uses, these regulations are difficult to poster sessions v enforce because many of these sites have been toxic-ridden for many years and investigation and cleanup of these sites can be expensive. removing health risks must be the main priority of all brown fields action plans. environmental health hazards are disproportionately concentrated in low-income communities of color. policy requirements and enforcement mechanisms to safeguard environmental health should be strengthened for all brownfields projects located in these communities. if sites are potentially endangering the health of the community, all efforts should be made for site remediation to be carried out to the highest cleanup standards possible towards the removal of this risk. the assurance of the health of the community should take precedence over any other benefits, economic or otherwise, expected to result from brownfields redevelopment. it's important to require from companies to observe a "good neighbor" policy that includes on-site visitations by a community watchdog committee, and the appointment of a neighborhood environmentalist to their board of directors in accordance with the environmental principles. vancouver - michael buzzelli, jason su, and nhu le this is the second paper of research programme concerned with the geographical patterning of environmental and population health at the urban neighbourhood scale. based on the vancouver metropolitan region, the aim is to better understand the role of neighbourhoods as epidemiological spaces where environmental and social characteristics combine as health processes and outcomes at the community and individual levels. this paper builds a cohort of commensurate neighbourhoods across all six censuses periods from to , assembles neighbourhood air pollution data (several criterion/health effects pollutants), and providing an analysis to demonstrate how air pollution systematically and consistently maps onto neighbourhood socioeconomic markers, in this case low education and lone-parent families. we conclude with a discussion of how the neighbourhood cohort can be further developed to address emergent priorities in the population and environmental health literatures, namely the need for temporally matched data, a lifecourse approach, and analyses that control for spatial scale effects. solid waste management and environment in mumbai (india) by uttam jakoji sonkamble and bairam paswan abstract: mumbi is the individual financial capital of india. the population of greater mumbai is , , and sq. km. area. the density of population , per sq. km. the dayto-day administration and rendering of public services within gr. mumbai is provided by the brihan mumbai mahanagar palika (mumbai corporation of gr. mumbai) that is a body of elected councilors on a -year team. mumcial corporation provides varies conservancy services such as street sweeping, collection of solid waste, removal and transportation, disposal of solid waste, disposal of dead bodies of animals, construction, maintance and cleaning of urinals and public sanitary conveniences. the solid waste becoming complicated due to increase in unplanned urbanization and industrialization, the environment has deteriorated significantly due to inter, intra and international migration stream to mumbai. the volume of inter state migration to mumbai is considerably high i.e. . lakh and international migrant . lakh have migrated to mumbai. present paper gives the view on solid waste management and its implications to environment and health. pollution from a wide varity of emission, such as from automobiles and industrial activities, has reached critical level in mumbai, causing respiratory, ocular, water born diseases and other health problems. sources of generation of waste are -household waste, commercial waste, institutional waste, street sweeping, silt removed from drain/nallah/cleanings. disposal of solid waste in gr. mumbai done under incineration . processing to produce organic manure. . vermi-composting . landfill the study shows that the quantity of waste disposal of through processing and conversion to organic ~anure is about - m.t. per day. the processing is done by a private agency m/s excel industries ltd. who had set up a plant at the chincholi dumping ground in western mumbai for this purpose. the corporation is also disposal a plant of its waste mainly market waste through the environment friendly, natural pro-ces~ known as vermi-composing about m.t. of market waste is disposed of in this manner at the various sites. there are four land fill sites are available and percent of the waste matter generated m mumbai is disposed of through landfill. continuous flow of migrant and increa~e in slum population is a complex barrier in the solid waste management whenever community pamc pat on work strongly than only we can achieved eco-friendly environment in mumbai. persons exposed to residential craffic have elevated races of respiratory morbidity an~ ~ortality. since poverty is an important determinant of ill-health, some h~ve argued that t~es~ assoc at ons may relate to che lower socioeconomic status of those living along ma or roads. our ob ect ve was to evaluate the association between traffic intensity at home and hospital admissions for respiratory diagnoses among montreal residents older than years. morning peak traffic estimates from the emmej montreal traffic model (motrem ) were used as an indicator of exposure to road traffic outside the homes of those hospitalised. the influence of socioeconomic status on the relationship between traffic intensity and hospital admissions for respiratory diagnoses was explored through assessment of confounding by lodging value, expressed as the dollar average over road segments. this indicator of socioeconomic status, as calculated from the montreal property assessment database, is available at a finer geographic scale than socioeconomic information accessible from the canadian census. there was an inverse relationship between traffic intensity estimates and lodging values for those hospitalised (rho - . , p vehicles during che hour morning peak), even after adjustment for lodging value (crude or . , cl % . - . ; adjusted or . , cl % . - . ). in montreal, elderly persons living along major roads are at higher risk of being hospitalised for respiratory illnesses, which appears not simply to reflect the fact that those living along major roads are at relative economic disadvantage. the paper argues that human beings ought to be at the centre of the concern for sustainable development. while acknowledging the importance of protecting natural resources and the ecosystem in order to secure long term global sustainability, the paper maintain that the proper starting point in the quest for urban sustainability in africa is the 'brown agenda' to improve che living and working environment of che people, especially che urban poor who face a more immediate environmental threat to their health and well-being. as the un-habitat has rightly observed, it is absolutely essential "to ensure that all people have a sufficient stake in the present to motivate them to take part in the struggle to secure the future for humanity.~ the human development approach calls for rethinking and broadening the narrow technical focus of conventional town planning and urban management in order to incorporate the emerging new ideas and principles of urban health and sustainability. i will examine how cities in sub-saharan africa have developed over the last fifty years; the extent to which government policies and programmes have facilitated or constrained urban growth, and the strategies needed to achieve better functioning, safer and more inclusive cities. in this regard i will explore insights from the united nations conferences of the s, especially local agenda of the rio summit, and the istanbul declaration/habitat agenda, paying particular attention to the principles of enablement, decentralization and partnership canvassed by these movements. also, i will consider the contributions of the various global initiatives especially the cities alliance for cities without slums sponsored by the world bank and other partners; che sustainable cities programme, the global campaigns for good governance and for secure tenure canvassed by unhabit at, the healthy cities programme promoted by who, and so on. the concluding section will reflect on the future of the african city; what form it will take, and how to bring about the changes needed to make the cities healthier, more productive and equitable, and better able to meet people's needs. heather jones-otazo, john clarke, donald cole, and miriam diamond urban areas, as centers of population and resource consumption, have elevated emissions and concentrations of a wide range of chemical contaminants. we have developed a modeling framework in which we first ~stimate the emissions and transport of contaminants in a city and second, use these estimates along with measured contaminant concentrations in food, to estimate the potential health risk posed by these che.micals. the latter is accomplished using risk assessment. we applied our modeling framework to consider two groups of chemical contaminants, polycyclic aromatic hydrocarbons (pah) a.nd the flame re~ardants polybrominated diphenyl ethers (pbde). pah originate from vehicles and stationary combustion sources. ~veral pah are potent carcinogens and some compounds also cause noncancer effects. pbdes are additive flame retardants used in polyurethane foams (e.g., car seats, furniture) fer sessions v and cl~ equipm~nt (e.g., compute~~· televisio~s). two out of three pbdes formulations are being voluntarily phased by mdustry due to rmng levels m human tissues and their world-wide distribution. pbdes have been .related to adv.erse neurological, developmental and reproductive effects in laboratory ijlimals. we apphed our modelmg framework to the city of toronto where we considered the southcattral area of by km that has a population of . million. for pah, local vehicle traffic and area sources contribute at least half of total pah in toronto. local contributions to pbdes range from - %, depending on the assumptions made. air concentrations of both compounds are about times higher downtown than km north of toronto. although measured pah concentrations in food date to the s, we estimate that the greatest exposure and contribution to lifetime cancer risk comes from ingestion of infant formula, which is consistent with toxicological evidence. the next greatest exposure and cancer risk are attributable to eating animal products (e.g. milk, eggs, fish). breathing downtown air contributes an additional percent to one's lifetime cancer risk. eating vegetables from a home garden localed downtown contributes negligibly to exposure and risk. for pbdes, the greatest lifetime exposure comes through breast milk (we did not have data for infant formula), followed by ingestion of dust by the toddler and infant. these results suggest strategies to mitigate exposure and health risk. p - (a) immigration and socioeconomic inequalities in cervical cancer screening in toronto, canada aisha lofters, rahim moineddin, maria creatore, mohammad agha, and richard glazier llltroduction: pap smears are recommended for cervical cancer screening from the onset of sexual activity to age . socioeconomic and ethnoracial gradients in self-reported cervical cancer screening have been documented in north america but there have been few direct measures of pap smear use among immigrants or other socially disadvantaged groups. our purpose was to investigate whether immigration and socioeconomic factors are related to cervical cancer screening in toronto, canada. methods: pap smears were identified using fee codes and laboratory codes in ontario physician service claims (ohip) for three years starting in for women age - and - . all women with any health system contact during the three years were used as the denominator. social and economic factors were derived from the canadian census for census tracts and divided into quintiles of roughly equal population. recent registrants, over % of whom are expected to be recent immigrants to canada, were identified as women who first registered for health coverage in ontario after january , . results: among , women age - and , women age - , . % and . %, rtspcctively, had pap smears within three years. low income, low education, recent immigration, visible minority and non-english language were all associated with lower rates (least advantaged quintile:most advantaged quintile rate ratios were . , . , . , . , . , respectively, p < . for all). similar gradients were found in both age groups. recent registrants comprised . % of women and had mm;h lower pap smear rates than non-recent registrants ( . % versus . % for women age - and . % versus . % for women age - ). conclnsions: pap smear rates in toronto fall well below those dictated by evidence-based practice. at the area level, immigration, visible minority, language and socioeconomic characteristics are associated with pap smear rates. recent registrants, representing a largely immigrant group, have particularly low rates. efforts to improve coverage of cervical cancer screening need to be directed to all ~omen, their providers and the health system but with special emphasis on women who recently arrived m ontario and those with social and economic disadvantage. challeges faced: a) most of the resources are now being ~pent in ~reventing the sprea.d of hiv/ aids and maintaining the lives of those already affected. b) skilled medical ~rs~nal are dymg under· mining the capacity to provide the required health care services. ~) th.e comphcat o~s of hiv/aids has complicated the treatment of other diseases e.g. tbs d) the ep dem c has led. to mcrease number of h n requiring care and support. this has further stretched the resources available for health care. orp a s d db . . i methods used on our research: . a simple community survey con ucte y our orgamzat on vo · unteers in three urban centres members of the community, workers and health care prov~ders were interviewed ... . meeting/discussions were organized in hospitals, commun.ity centre a~d with government officials ... . written questionnaires to health workers, doctors and pohcy makers m th.e health sectors. lessors learning: • the biggest-health bigger-go towards hiv/aids prevention • aids are spreading faster in those families which are poor and without education. •women are the most affected. •all health facilities are usually overcrowded with hiv/aids patients. actions needed:• community education oh how to prevent the spread of hiv/aids • hiv/aids testing need to be encouraged to detect early infections for proper medical cover. • people to eat healthy • people should avoid drugs. implications of our research: community members and civic society-introduction of home based care programs to take care of the sick who cannot get a space in the overcrowded public hospitals. prl-v a te sector private sector has established programs to support and care for the staff already affected. government provision of support to care-givers, in terms of resources and finances. training more health workers. introduction: australian prisons contain in excess of , prisoners. as in most other western countries, reliance on 'deprivation of liberty' is increasing. prisoner numbers are increasing at % per annum; incarceration of women has doubled in the last ten years. the impacts on the community are great - % of children have a parent in custody before their th birthday. for aboriginal communities, the harm is greater -aboriginal and/or torres strait islanders are incarcerated at a rate ten times higher than other australians. % of their children have a parent in custody before their th birthday. australian prisons operate under state and territory jurisdictions, there being no federal prison system. eight independent health systems, supporting the eight custodial systems, have evolved. this variability provides an unique opportunity to assess the capacity of these health providers in addressing the very high service needs of prisoners. results: five models of health service provision are identified -four of which operate in one form or another in australia: • provided by the custodial authority (queensland and western australia)• pro· vided by the health ministry through a secondary agent (south australia, the australian capital territory and tasmania) • provided through tendered contract by a private organization (victoria and northern territory) • provided by an independent health authority (new south wales) • (provided by medics as an integral component of the custodial enterprise) since the model of the independent health authority has developed in new south wales. the health needs of the prisoner population have been quantified, and attempts are being made to quantify specific health risks /benefits of incarceration. specific enquiry has been conducted into prisoner attitudes to their health care, including issues such as client information confidentiality and access to health services. specific reference will be made to: • two inmate health surveys • two inmate access surveys, and • two service demand studies. conclusions: the model of care provision, with legislative, ethical, funding and operational independence would seem provide the best opportunity to define and then respond to the health needs of prisoners. this model is being adopted in the united kingdom. better health outcomes in this high-risk group, could translate into healthier families and their communities. p - (a) lnregrated ethnic-specific health care systems: their development and role in increasing access to and quality of care for marginalized ethnic minorities joshua yang introduction: changing demographics in urban areas globally have resulted in urban health systems that are racially and ethnically homogenous relative to the patient populations they aim to serve. the resultant disparities in access to and quality of health care experienced by ethnic minority groups have been addressed by short-term, instirutional level strategies. noticeably absent, however, have been structural approaches to reducing culturally-rooted disparities in health care. the development of ethnic-specific h~alth car~ systems i~ a structural, long-term approach to reducing barriers to quality health care for eth· me mmonty populations. methods: this work is based on a qualitative study on the health care experiences of san francisco chinatown in the united states, an ethnic community with a model ethnic-specific health care infrastrucrure. using snowball sampling, interviews were conducted with key stakeholders and archival research was conducted to trace and model the developmental process that led to the current ethnic-specific health care system available to the chinese in san francisco. grounded theory was the methodology ijltd to analysis of qualitative data. the result of the study is four-stage developmental model of ethnic-specific health infrastrueture development that emerged from the data. the first stage of development is the creation of the human capital resources needed for an ethnic-specific health infrastructure, with emphasis on a bilingual and bicultural health care workforce. the second stage is the effective organization of health care resources for maximal access by constituents. the third is the strengthening and stability of those institutional forms through increased organizational capacity. integration of the ethnic-specific health care system into the mainstream health care infrastructure is the final stage of development for an ethnic-specific infrastructure. conclusion: integrated ethnic-specific health care systems are an effective, long-term strategy to address the linguistic and cultural barriers that are being faced by the spectrum of ethnic populations in urban areas, acting as culturally appropriate points of access to the mainstream health care system. the model presented is a roadmap to empower ethnic communities to act on the constraints of their health and political environments to improve their health care experiences. at a policy level, ethnic-specific health care organizations are an effective long-term strategy to increase access to care and improve qualiiy of care for marginalized ethnic groups. each stage of the model serves as a target area for policy interventions to address the access and care issues faced by culturally and linguistically diverse populations. users in baltimore md: - noya galai, gregory lucas, peter o'driscoll, david celentano, david vlahov, gregory kirk, and shruti mehta introduction: frequent use of emergency rooms (er) and hospitalizations among injection drug users (idus) has been reported and has often been attributed to lack of access to primary health care. however, there is little longitudinal data which examine health care utilization over individual drug use careers. we examined factors associated with hospitalizations, er and outpatient (op) visits among idus over years of follow-up. methods: idus were recruited through community outreach into the aids link to lntravenous experience (alive) study and followed semi-annually. , who had at least follow-up visits were included in this analysis. outcomes were self-reported episodes of hospitalizations and er/op visits in the prior six months. poisson regression was used accounting for intra-person correlation with generalized estimation equations. hits: at enrollment, % were male, % were african-american, % were hiv positive, median age was years, and median duration of drug use was years. over a total of , visits, mean individual rates of utilization were per person years (py) for hospitalizations and per py for er/op visits. adjusting for age and duration of drug use, factors significantly associated with higher rates of hospitalization included hiv infection (relative incidence [ri(, . ), female gender (ri, . ), homelessness (ri, . ), as well as not being employed, injecting at least daily, snorting heroin, havmg a regular source of health care, having health insurance and being in methadone mainte.nance treatment (mmt). similar associations were observed for er/op visits except for mmt which was not associated with er/op visits. additional factors associated with lower er/op visits were use of alcohol, crack, injecting at least daily and trading sex for drugs. % of the cohort accounted for % of total er/op visits, while % of the cohort never reported an op visit during follow-up. . . . lgbt) populations. we hypothesized that prov dmg .appomtments .for p~t ~nts w thm hours would ensure timely care, increase patient satisfaction, and improve practice eff c ency. further, we anticipated that the greatest change would occur amongst our homeless patients.. . methods: we tested an experimental introduction of advanced access scheduling (usmg a hour rule) in the primary care medical clinic. we tracked variables inclu~ing waiting ti~e fo~ next available appointment; number of patients seen; and no-show rates, for an eight week penod pnor to and post introduction of the new scheduling system. both patient and provider satisfaction were assessed using a brief survey ( questions rated on a -pt scale). results and conclusion: preliminary analyses demonstrated shorter waiting times for appointments across the clinic, decreased no-show rates, and increased clinic capacity. introduction of the advanced access scheduling also increased both patient and provider satisfaction. the new scheduling was initiated in july . quantitative analyses to measure initial and sustained changes, and to look at differential responses across populations within our clinic, are currently underway. introduction: there are three recognized approaches to linking socio-economic factors and health: use of census data, gis-based measures of accessibility/availability, and resident self-reported opinion on neighborhood conditions. this research project is primarily concerned with residents' views about their neighborhoods, identifying problems, and proposing policy changes to address them. the other two techniques will be used in future research to build a more comprehensive image of neighborhood depri· vation and health. methods: a telephone survey of london, ontario residents is currently being conducted to assess: a) community resource availability, quality, access and use, b) participation in neighborhood activities, c) perceived quality of neighborhood, d) neighborhood problems, and e) neighborhood cohesion. the survey instrument is composed of indices and scales previously validated and adapted to reflect london specifically. thirty city planning districts are used to define neighborhoods. the sample size for each neighborhood reflects the size of the planning district. responses will be compared within and across neighborhoods. data will be linked with census information to study variation across socio-eco· nomic and demographic groups. linear and gis-based methods will be used for analysis. preliminary results: the survey follows a qualitative study providing a first look at how experts involved in community resource planning and administration and city residents perceive the availability, accessibility, and quality of community resources linked to neighborhood health and wellbeing, and what are the most immediate needs that should be addressed. key-informant interviews and focus groups were used. the survey was pre-tested to ensure that the language and content reflects real experiences of city residents. the qualitative research confirmed our hypothesis that planning districts are an acceptable surrogate for neighborhood, and that the language and content of the survey is appropriate for imple· mentation in london. scales and indices showed good to excellent reliability and validity during the pre· test (cronbach's alpha from . - . ). preliminary results of the survey will be detailed at the conference. conclusions: this study will help assess where community resources are lacking or need improve· ment, thus contributing to a more effective allocation of public funds. it is also hypothesized that engaged neighborhoods with a well-developed sense of community are more likely to respond to health programs and interventions. it is hoped that this study will allow london residents to better understand the needs and problems of their neighborhoods and provide a research foundation to support local understandmg of community improvement with the goal of promoting healthy neighborhoods. p - (a) hiv positive in new york city and no outpatient care: who and why? hannah wolfe and victoria sharp introduction: there are approximately million hiv positive individuals living in the united sta!es. about. % of these know their hiy status and are enrolled in outpatient care. of the remaining yo, approx~mately half do not know their status; the other group frequently know their status but are not enrolled m any .sys~em of outpatient care. this group primarily accesses care through emergency departments. when md cated, they are admitted to hospitals, receive acute care services and then, upon poster sessions v di 'harge, disappear from the health care system until a new crisis occurs, when they return to the emergency department. as a large urban hiv center, caring for over individuals with hiv we have an active inpatient service ".'ith appr~xi~.ately discharges annually. we decided to survey our inpatients to better charactenze those md v duals who were not enrolled in any system of outpatient care. results: % of inpatients were not enrolled in regular outpatient care: % at roosevelt hospital and % at st.luke\'s hospital. substance abuse and homelessness were highly prevalent in the cohort of patients not enrolled in regular outpatient care. % of patients not in care (vs. % of those in care) were deemed in need of substance use treatment by the inpatient social worker. % of those not in care were homeless (vs. % of those in care.) patients not in care did not differ significantly from those in me in terms of age, race, or gender. patients not in care were asked "why not:" the two most frequent responses were: "i haven't really been sick before" and "i'd rather not think about my health. conclusions: this study suggests that there is an opportunity to engage these patients during their stay on the inpatient units and attempt to enroll them in outpatient care. simple referral to an hiv clinic is insufficient, particularly given the burden of homelessness and substance use in this population. efforts are currently underway to design an intervention to focus efforts on this group of patients. p .q (a) healthcare availability and accessibility in an urban area: the case of ibadan city, nigeria in oder to cater for the healthcare need of the populace, for many years after nigeria's politicl independence, empphasis was laid on the construction of teaching, general, and specialist hospital all of which were located in the urban centres. the realisation of the inadequacies of this approach in adequately meeting the healthcare needs of the people made the country to change and adopt the primary health care (phc) system in . the primary health care system which is in line with the alma ata declaration of of , wsa aimed at making health care available to as many people as possible on the basis of of equity and social justice. thus, close to two decades, nigeria has operated primary health care system as a strategy for providing health care for rural and urban dwellers. this study focusing on urban area, examimes the availabilty and accessibility of health care in one of nigeria's urban centre, ibadan city to be specific. this is done within the contest of the country's national heath policy of which pimary health care is the main thrust. the study also offers necessary suggestion for policy consideration. in spite of the accessibility to services provided by educated and trained midwifes in many parts of fars province (iran) there are still some deliveries conducted by untrained traditional birth attendants in rural parts of the province. as a result, a considerable proportion of deliveries are conducted under a higher risk due to unauthorised and uneducated attendants. this study has conducted to reveal the pro· portion of deliveries with un-authorized attendants and some spatial and social factors affecting the selection of delivery attendants. method: this study using a case control design compared some potentially effective parameters indud· ing: spatial, social and educational factors of mothers with deliveries attended by traditional midwifes (n= ) with those assisted by educated and trained midwifes (n= ). the mothers interviewed in our study were selected from rural areas using a cluster sampling method considering each village as a cluster. results: more than % of deliveries in the rural area were assisted by traditional midwifes. there are significant direct relationship between asking a traditional birth attendant for delivery and mother age, the number of previous deliveries and distance to a health facility provided for delivery. significant inverse relationships were found between mother's education and ability to use a vehicle to get to the facilities. conclusion: despite the accessibility of mothers to educated birth attendants and health facilities (according to the government health standards), some mothers still tend to ask traditional birth attendants for help. this is partly because of unrealistic definition of accessibility. the other considerable point is the preference of the traditional attendants for older and less educated mothers showing the necessity of changing theirs knowledge and attitude to understand the risks of deliveries attended by traditional and un-educated midwifes. p - (a) identification and optimization of service patterns provided by assertive community treatment teams in a major urban setting: preliminary findings &om toronto, canada jonathan weyman, peter gozdyra, margaret gehrs, daniela sota, and richard glazier objective: assertive community treatment (act) teams are financed by the ontario ministry of health and long-term care (mohltc) and are mandated to provide treatment, rehabilitation and support services in the community to people with severe and persistent mental illness. there are such teams located in various regions across the city of toronto conducting home visits - times per week to each of their approximately respective clients. each team consists of multidisciplinary health professionals who assist clients to identify their needs, establish goals and work toward them. due to complex referral patterns, the need for service continuity and the locations of supportive housing, clients of any one team are often found scattered across the city which increases home visit travel times and decreases efficiency of service provision. this project examines the locations of clients in relation to the home bases of all act teams and identifies options for overcoming the geographical challenges which arise in a large urban setting. methods: using geographic information systems (gis) we geocoded all client and act agency addresses and depicted them on location maps. at a later stage using spatial methods of network analysis we plan to calculate average travel rimes for each act team, propose optimization of catchment areas and assess potential travel time savings. resnlts: initial results show a substantial scattering of clients from several act teams and substan· rial overlap of visit travel routes for most teams. conclusions: reallocation of catchment areas and optimization of act teams' travel patterns should lead to substantial savings in travel times, increased service efficiency and better utilization of resourc_~· ~e l'<!tenri~i modifications to catchment areas must be conducted with appropriate attention to specific clients servtce needs, service continuity and applicable regulations by the mohl tc. venice lido is a popular island within and outside italy because it hosts the international cinema festival yearly. only few people remember the island for its hospital, which, in the fifties, was one of the most important hospitals in italy and in europe, being a modern center for wind-, sun-and thermal-therapy. since the sixties, its fame became to drop away, since its structure was no longer adequate for the evolving medicine science. at the end of the seventies all the wards were moved into a new big building in the same area. at present the hospital is made up by about forty 'pavilions' (mostly partially used or empty) and a big building, disseminated in a hectares area, on the sea front, on the m long beach. the aim of my research is to suggest a realistic solution, sustainable on the functional use of the area according to basic local needs and economically realizable. i used a philological and multi-disciplinary method, more in detail: -from historical documents, i found what was the very first call of the property and how it adapted to the needs of the demographic development and the sanitary supply over time; -by contacting some operators from different fields, i realized which functions were suitable to the buildings in existence, to the population's needs and to the present sanitary supply. moreover the planning idea considers: -the debate going on between local people who strongly want to preserve the property, and die ones who want to renew it by different new opportunities; and -the regional sanitary politics, aiming at rationalizing the regional hospitals dislocation, and the budget needs. this plan analyzes and proposes some new alternative solutions to satisfy different needs. the different activities will be dealt out and the environmental fall will be limited as much as possible. after having analyzed its basic call, considered its environmental peculiarities and its position, verified the emerging needs of the local population, the plan proposes different activities: the hospital; the social-rehabilitation center; the elderly house; the thermal center; the residential center; and other activities. such a plan wants to share in the solution of a basic problem by giving architectonic and functional dignity to an historical completely degraded area and by starting again a social-economical broken off process, by bringing in venice lido some fresh necessary elements for its so wished new throw. p - (c) dilemma of free health care in spokane, wa david bunting introduction: the paper reports on the activities of project access spokane [pas], a physician sponsored initiative to provide uncompensated health care to low income, uninsured residents of spokane county wa. program providers included all county hospitals, over physicians, other medical professionals, and specialized clinics. each prescription requires only a $ co-payment. sponsored and administered by the county medical society, pas is funded by local and national foundations, private corporations, municipalities, civic organizations and individuals. method: the paper is based on a first year assessment report funded by pas, using hcfa [health care financing administration] insurance claim data documenting utilization rates, disease categories and donated charge information and patient cares [centralized applications, referrals and enrollment status) data. results: while essentially free for enrollees, the program involved real costs. an administrative organization to refer over patients to any of over providers had to be developed and staffed, using both paid and unpaid personnel. methods to identify potential patients and veri.fy eligibility. had to ~devised. patient appointments and transportation had to be scheduled and monitored. pu~hc relanons, provider solicitations and fundraising activities were continuous. information requirements regarding program operation were also significant. data reporting the volume. ~nd value of dona~ed medical services were necessary to demonstrate accomplishments and attr~ct addmon~l support. providers required assurances their contributions were both significant and eqmtable. funding sources sought evidence that their support had important consequences. however, generating this ~~ta proved difficult. many providers failed to submit appropriate insurance claims forms because .of a~dmonal donated effort and administrative cost, thereby not only reducing their own apparent conmbut ons but also the overall significance of the program. conclusions: during its initial year, the estimated cost to deliver free health care was ~bout per enrollee. the lesson is that without an elaborate administrative structure and record keeping s.yst~~· efforts to provide free health care probably will fail. eligible enrollees c~n not be ~parated from in~hgi ble ones, care will not be accessed or delivered in an efficient manner, neither fundmg nor ~upport "". be offered without evidence of tangible benefits, and providers will withdraw if they perceive mequ table tteannent. v p - s (c) mobility in prostitution and the impact of health therese van der helm and henk sulman poster sessions introduction: many of the estimated . commer~ial ~ex wor~ers (c~w)in a'.' ~terdam ~~me from developing countries and eastern europe. to gain ins~ght mto their workmg and_ hvmg condinons the intermediary project (ip) at the municipal health serv ~e _contacts these women via ?utreach work on regular basis. since the new brothel law in october s ~troduc~d, ~sw ~rom outside the eu and who have no dutch residence permit are not allowed to work m prost tut n. smee then, many of these csw therefore have gone "underground." the consequences of the new law in the netherlands will be discussed with regard to the accessibility of csw and their risk for stl/hiv acquisition and unplanned pregnancies. methods: topics during outreach work are the interventions to increase the knowledge of safe sex and birth control for csw. written information is handed out in relevant languages and with addresses of health and social services. in conversations with the women, it appeared that many are not aware of these services. to provide easier access to health care for women, staff of the ip carries out free sti control csw working places, in windows brothels and sex houses. also, women are offered vaccination against hepatitis b (hbv). results: from january till july we approached csw for first contact. one third was dutch; others were from developing countries, other eu countries and eastern europe. sti consul· rations were done among non-iv drug using sex workers, of whom % was dutch. of these, % was diagnosed with syphilis, % with gonorrhea, and % with chlamydia. of women tested for hiv, none were infected. due to the high turnover of csw in .brothels, most wnmen were tested only once. among csw tested for hbv -of whom one third is dutch - % had antibodies for hbv, were carrier of hbv, most of whom came from hbv endemic areas. conclusions: sti control and hbv vaccination in brothels is an important support in health care. our findings suggest that csw do not play an important role in the transmission of sti. many csw are highly mobile and often not aware of the existing health and social services. continuous outreach is important to remain in contact with this mobile population. regulations in the new brothel law should not hamper contacts with (illegal) csw. heart disease (cho) is projected to become the leading cause of death. studies conducted in europe and the united states have proven a higher rate of cho in south asians who have migrated from south asia, most notably india, pakistan and bangladesh. approximately % of all heart attacks among south asian men occur under the age of ; % of them occur under the age of -unheard of in any other population. associated risk factors such as diabetes, high blood pressure and cholesterol are also com· mon in this group. the population of south asians residing in nyc has more than doubled over the past decade to over , , the majority being young, working-class and with limited health care access. many south asian men are employed as taxi drivers ( out of nyc taxi drivers are from south asial, working daily hour plus shifts. methods: acknowledging that this vulnerable, at-risk group was unavailable for outreach through conventional venues, three of the hospitals of the new york city health and hospital corporation, (elmhurst, queens and bellevue) conducted a one day outreach effort at nyc's jfk international air· ~rt's taxi holdin~ ar~a, ~here over one thousand taxis regularly assemble. bringing an outreach event directly to the taxi dnvers workplace, a tent was set up where cardiovascular-related health screenings, in~luding bl~ pressure, sugar, cholesterol, body mass index (bmi), were provided. results were shared with and explamed to the drivers and each participant received a south asian health education brochure. a total of taxi drivers who identified as south asian were involved. rau/ts: participants were all male, ranging from to years; mean age, . . screenings revealed % hypertensive; % had cholesterols over ; % blood glucose over ; % had a bmi greater than . conc~on: a unique outreach activity, adapting to logistical, occupational limitations, is pre· se~ted. on-site f~back and explanation of results, reiterating and reinforcing the concern that south asia~. men are at mcreased danger for early coronary heart disease, and the dissemination of a culturally sensmve and r~levant brochure, may heighten awareness of prevailing cardiac risk factors in this immi· grant community. p - (c) the community-hospital integration program framework: community-hospital panoenhips to improve the population's health john stevenson, richard blickstead, ann-marie marcolin, and sandi kendal v introduction: st. josephs health centre is a catholic community teaching hospital located in the heart of southwest toronto. st. joseph\'s was founded from a community-expressed need for hospital services, and since then has stayed committed to fostering a healthy community through collaboration and parmership. st. joseph's has developed an innovative model, the community-hospital integration program (chip), to strengthen st. joseph's partnerships with community stakeholders, and facilitates the building of links between community needs, service provision, and public policy outcomes to improve the health and wellness of the diverse neighbourhoods they together serve. methods: development of the chip framework st. joseph's health centre developed the chip framework through a multidisciplinary approach that included extensive international literature reviews, consultations, and key informant interviews with community service agencies and academics. to ensure active community voice, st. joseph's has hosted a number of community consultations including a community outreach forum attended by over ninety representatives from community partners. results: the chip framework the chip framework aims to improve the health and wellness of the urban communities served by st. josephs health centre through four intersecting pillars: • raising community voices provides an infrastructure and process that supports community stakeholder input into health care service planning, decision-making, and delivery by the hospital and across the continuum of care; • sharing reciprocal capacity promotes healthy communities through the sharing of our intellectual and physical capacity with our community partners; • cultivating integration initiatives facilitates vertical, horizontal, and intersectoral integration initiatives in support of community-identified needs and gaps; and • facilitating healthy exchange develops best practices in community integration through community-based research, and facilitates community voice in informing public policy. the chip framework drives the complex inter-relationships between community-hospital engagement, reciprocal capacity-building, integration initiatives, and community-based research and evaluation, to create an interconnected network of health care services. the fluidity and simplicity of this framework, and its dedication to balancing community needs and hospital mandate, posits the st. josephs health centre's chip model as an integral component in building healthy and thriving communities. p - (c) home based care promotion: improving acess to quality services and livelihood in the face of aids home based care is a service provided to persons affected/living with hiv/aids, a menu of care/support services at home/community. it is a prominent alternative approach. in uganda, hospital bed ocupacny is high, patient health care worker ratio deteriorating. empowering communities offers solutions to the problems; adressing cost, effectiveness of care. hiv/aids demands changes in attitudes, behaviour, approaches which is enhanced in home/community settings. for example art requires high levels of adherecnce, which medical workers have vety little opportunity to enforce. it also demands other support mechanisims in terms of nutrition, personal displine, etc which work best in stigma free environments. hence the relevance of home based care. this paper highlights the gaps that call for increased action in terms of home based care, examples of whre it has worked key challenges and recommendations for the future. p - (c) health care for one ... health care for alli katharina kovacs burns introduction: at the surface, it appears that every person in canada _has. ~ccess to a publicly funded health care system. those living in urban centers should have the best ava l~b hty, chmce, and access to a variety of health care services because of the distribution of health care services, fac lmes, and health professionals in concentrated in urban centers. this is not true for everyone -people with low income or who are homeless experience the challenges of social exclusion and being marginalized: there are many factors at play making it difficult for the latter group of people to access health care. service they need,.when they need them. health care is not as accessible or inclusive as intended. the quesuon to be explore.cl ~: if health care is available and accessible to one person, what makes it not available to all people? the ~ gmfic~nce of having marginalized people accessing health care and other services includes e~hanced quality of hfe and decreased risks associated with being homeless, and cost savings in ion~ ter~ w rh acute health care. methodology: community-based participatory research is applied m a case study on health care access and challenges experienced by low income and homeless people in one urban centre, edmonton, edmonton, and their challenges. the data is being gathered and ana_lyzed usmg basic m x~d methods. results: the results will focus on how services can be more mtegrated and accessible to all people with low income and who are homeless. there will also be discussion about specific perceptions of not only the service providers but also of people with low income an~ who are homeless~ and vario~s decision makers. the results will be compared to the literature regardmg health care services access mother urban centers in canada and elsewhere. conclusions: recommendations will need to address social exclusion and other factors which can make health care and other services more available to all people in the community. the implications for health care will also be discussed. additional information will be gathered in the next phases of the study to develop a community services access model. p - (c) availability and access exemplified: a case study beth hayhoe and ruth ewert introduction: access to health care in canada requires either the correct documentation or money. street youth have neither. in addition, health services in canada are designed by adults for adults. youth in general are often wary of having trust in adults with respect to their health concerns and frequently feel misunderstood. street youth are even more mistrustful of adults and public organizations, making their contact with health care professionals minimal. this combined with their risky behaviours and dangerous environment creates a population at risk for numerous health issues but with no place to have them investi· gated. at our non-government, not for profit health service designed specifically to provide a broad range of health care to street youth, professional services are provided almost entirely by volunteers. methods: using a retrospective analysis of the years of data gathered from this organization and reviewing the initial reasons gathered from youth about their needs, the success of the health centre was examined. results: all the things youth had listed as being important in a health centre have been implemented, and even more things have been added to improve the breadth and quality of services offered. the use of the health centre has increased by more than six times since its opening in . in addition, tens of thousands of visits have been paid to the health centre, costing the government and taxpayers nothing. as far as we know there is nothing else in canada that offers so many diverse and innovative services to youth in need. conclusion: it is clear from this case, that health care targeted at the needs of specific disadvan· taged populations can successfully provide them with appropriate health care. a model of accessible health care for marginalized populations can easily be developed for high impact and low cost from this successful case. toronto is one of the most ethno-racially diverse cities in the world of the estimated , , toronto residents, % ( , ) live in scarborough population growth in scarborough is faster than toronto. scarborough's population increased by % from to while toronto increased only by %. toronto's population is projected to increase by % ( ) in while scarbor· ough's will increase by %. (census canada ) low income, pove;ty, seniors, hidden homeless, new~omers to canada, the uninsured, are just a few of the issues concerning health care in our community. health care needs in scarborough are greatly impacted by diversity of ethnic and racial groups, poverty and settlement issues. this paper will share how the scarborough hospital (tsh) an urb~n communir_y hospital cares f~~ it~ community. tsh recognizes: •the changing community• b_arriers t~ accessing care • lnequalmes m health care the hospital in caring for its community pro· v ~es services that '!'e~e cu~turally, racially, and linguistically sensitive to our community. the paper will share the hospitals unique program on access and equity. the paper will share the needs in scar· borough and tsh's response to these needs: working in partnership with the local health committee, i:ne scarborough homeless co.mminee, the scarborough network of immigrant services organiza· nons a~d others. :' e paper will also share the many initiatives this urban community hospital has taken viz. community and home programs in service areas such as mental health, haemodialysis day care, t~~ home oxyg~n program, the palliative at-home program, and above all support for the volunteer clinic for the uninsured. j"'" tllu:lion: in canada's universal health care system it is generally assumed that everyone has equal access to health care. however, some immigrant groups in canada have historically been uninswed. these groups include failed refugee claimants, those overstaying their visas, and new immigrants in transition who are waiting to become eligible for health insurance. some estimates have suggested that at the present time there may be as many as one hundred thousand undocumented and thus uninsured immigrants in toronto alone. understandably, information on the characteristics of this marginalized population is very limited, since undocumented immigrants tend to have little contact with formal institutions. knowledge of the demographic characteristics of this population may aid in the development of health and social programs to better identify and meet the needs of undocumented immigrants in toronto. we conducted a review of all undocumented, uninsured patients, years of age or older at access alliance multicultural community health centre (aamchc) between and . demographic information such as age, gender, preferred language, length of time living in canada, selfreported education level and household income were recorded. rmdts: % of all adult patients at access alliance were undocumented and uninsured. % were under years of age (with a median age of years), % were women and only % spoke english. this group lived in canada for an average period of . years before they were first seen at aamchc. % of undocumented clients reported having completed at least a secondary or post-secondary education. % had self-reported household incomes of less than , $/year, while % of households reported earning less than $ , /year. the mean income per person in an average household was $/month. conchuions: uninsured individuals at aamchc were predominantly young females with limited knowledge of the english language. despite having attained a high level of education most were living well below the poverty line. recognition of these characteristics may assist in the development of health and social programs that are better adapted to meet the needs of undocumented immigrants. p - (c) sharing expertise: a role for the hospital lactation consultant in the community. badrgrmuul: st. michael's hospital is a tertiary care hospital that serves a large inner city population in downtown toronto. in order to provide care to this population, the hospital has developed a number of unique outreach roles. one such role was developed to work with pregnant and breastfeeding women living in regent park, a social housing complex located near the hospital. the population of regent park includes new immigrants, refugees and the socially disadvantaged. approach: the outreach lactation consultant provides care, as part of the canada prenatal nutrition program, in the community prenatally, in the hospital during their inpatient stay and postnatally when they return to the community. the continuity of care enhances the probability of long term successful breastfeeding. aside from the health benefits of breastmilk, breastfeeding is especially important for women who are financially needy and must depend on food banks for formula. . . lason learned: aher two years of partnership, the relationship between the an-hospital ~stpar tum experience for breastfeeding mothers and the community postpartum support, the breastfeeding rate ~thin this community is high. the professional support and visibility of the : ctation consultant, both m the hospital and in the community, contributes to the support of breastfee~m~.. . in light of ongoing funding constraints, this ha son between hospital and community could be at risk and discontinued. in light of the benefits to the mother/baby dyad, the lactation consultant as a community partner in the canada prenatal nutrition program should be safeguarded. . lldpodiu:tion: although the importance of adequate health care in pregna~cy is well recognised, ethnic disparities in utilization of prenatal care still exist in many western coun~~es. a fun~amental factor in these disparities may be language proficiency, as it influences women's ab hty. to ob~m and understand health information, to find the way in the health care system and to communicate with health care v poster sessions providers. we investigated the role of language proficiency in use and knowledge of folic acid as aspect of prenatal care in an urban multi-ethnic pregnancy c?hort. . . design: prospective cohort study. setting and parnc pants: amsterdam ~regnant women attending obstetric care providers for their first antenatal visit (n= ). country of birth defined ethnicity: the netherlands, surinam, antilles, turkey, morocco, ghana, other non-~est~m (nw) and other western (w) country. main outcome measures: knowledge about and use of.fohc a~d (fa) supplements in pregnancy, and determinants of these in diffe~~t ethnic ~~ups. deterrrunants mcl~ded age, ed~ tion, parity, pregnancy intention and dutch prof c ency. stansncs: ~ to co~p~re e~c groups, stranfied logistic regression (forward stepwise method) to explore determmants "'.'thm ethmc groups .. use of fa supplements was significantly lower among ghanaian, moroccan, turkish and other nw women ( %to %) than among dutch ( %) or other w women ( %). use amongsurinames and antillean women was intermediate ( %and %). ethnic differences in fa knowledge were similar. knowledge was the strongest determinant of use in all ethnic groups, with odds ratios (ors) ranging from . to . . language proficiency was the strongest determi~a~t of kno~ledge in ethnic groups with a mother tongue different from dutch (ors good vs. low proficiency ranging from . ro . ). educational level had a modifying role, as shown by an interaction effect between education and language proficiency in the nw group. here, the odds of having fa knowledge given a high education and good dutch proficiency was times the odds given a good proficiency but low education. conclusions: appropriate periconceptional use of folic acid supplements in non-western ethnic groups is low, reflecting an absence of knowledge that is largely determined by the inability to speak and understand the language of the habitual country. tailored interventions using communication channels most likely to address (pregnant) women from ethnic minority groups are necessary. apan from specific interventions, our results are in support of strong incentives on language education despite current political debate. introduction: recent research suggests living in an economically disadvantaged neighborhood is asso· ciated with decreased likelihood of undergoing mammography and increased risk of late-stage breast can· cer diagnosis. long distances and travel times to facilities offering low-or no-cost mammography may be imponant barriers to adherence to mammography screening recommendations for residents of economically disadvantaged neighborhoods. the purpose of this study was to examine whether facilities providing low-and no-cost screening mammography were less spatially accessible in low-income neighborhoods in chicago, and the extent to which the relationship between neighborhood income and the spatial accessibility of facilities varied by the proponion of african-american residents in the neighborhood. methods: the sample consisted of chicago neighborhoods. for each neighborhood, we con· structed three measures of the spatial accessibility of facilities: street network distance to the nearest facility, public transportation travel time to the nearest facility, and shortest automobile travel time to a facility. using decennial census data, we characterized the neighborhoods according to proportion of residents with incomes below the poverty line, proportion of residents in each of four raciavethnic groups (african-american, latino, white, and other), and population density. we used ordinary least squares (ols) and spatial exogenous lag regression to examine relationships. model estimated the relationship between neighborhood poverty and the spatial accessibility of facilities, adjusting for raciaveth· nic composition and population density. model added a multiplicative interaction term between neighborhood poverty and african-american. restllts: we identified deven facilities that provided low-or no-cost screening mammography to chicago residents in . we found that the distance and travel times via automobile and public trans· portation to facilities generally decreased as neighborhood poveny increased. however, we also found that the ~egative associations between neighborhood poverty and two of the spatial accessibility mea· sures -distance and public transportation travel time -were less strong in neighborhoods with the highest proponions of african-american residents. among neighborhoods in the highest tertile for poveny, th~ mean distance and mean public transportation travel time to facilities were over twice as long in neighborhoods in the highest tertile than in those in the lowest tenile of african-american residents. . ~ persistent socioeconomic and racial/ethnic disparities in breast cancer stage at diagno-s ~nd su~ val suggest that ensuring an equitable distribution of affordable mammography is a worth-w~e policy .goal. the ~~dy sugges~ that ~ture investigations should consider both neighborhood soc oecono d c charactensbes and rac avethmc composition when examining the spatial distribution of health resources. , ) . epidemiological data suggest tha~ hiv prevalence among msm is over % in some metropolitan cities, such .as beijing (ibid.). due to widespread homophobia in chinese society, however, this population remains invisible within current health/social services. lack of research on sexuality, specifically homosexuality, has impaired our understanding of health and health practices of chinese msm. focusing on the illness experiences of chinese msm with hiv/aids, this paper explores the socio-cultural impacts of hiv/ aids on this group. the data used for this paper were collected through semi-constructed in-depth face-toiace interviews with adult plwhas (including msm) in beijing, china. with the permission of the participants, the interviews were audio-taped or recorded in notes. the transcribed interviews and interview notes were analyzed by using n-vivo, a software program for qualitative data analysis. this phenomenological study aimed to understand the experiences chinese plwhas (including msm) from their own perspectives. results: it is found that the illness experiences of chinese msm with hiv/aids are profoundly shaped by the socio-cultural meanings of homosexuality, which are further complicated by the dominant discourses on hiv/aids in china. at a macro level, homophobia in the larger society has decreased the capability of this group to respond to this epidemic in a more efficient way. at a meso level, aids-phobia within the chinese msm circuits has prevented this group from openly confronting this disease and offering support to those who are already affected by it. at a micro level, however, these hiv-infected/ affected msm have tried their best to locate spaces to live and to construct hope for their future lives despite various barriers within family, community, and the larger society. this study suggests that facilitating chinese msm's response to the aids crisis urgently requires bridging awareness, commitment, knowledge and resources both within and without this group. it also illustrates the importance of understanding homosexuality in the local context of hiv i aids, which will be helpful for developing culturally sensitive hiv/aids programs for this population on the community, national and international levels. introduction: having a regular family doctor (rfd) is known to be positively correlated with a good medical follow up, including access to preventive and/or chronic care. inversely, a lack of primary care may lead to high rates of avoidable hospitalizations, especially among poor people and/or in underserved neighbourhoods. in such a matter, a recent comparative study showed that paris was better ranged than other cities, such as nyc, tokyo or london. nevertheless, despite a quasi universal health insurance and a high density of general practitioners, a noticeable fraction of the paris population does not have any regular physician and we aimed to understand who they are and for what reasons rhey don't have any rfd. mdbods: cross sectional population survey among a random sample of households in ~nderpriv ileged neighbourhoods in paris inner city, performed in , using a face-to-face quest nna re collecr- ng more than social and health characteristics. ruults: a quarter ( . %) of rhe study popularion did not have any rfd. this proporrion was iignificantly higher among male (or= . , %ci = [ . - . ), younger (e.g. or - /> .s l _= ._oo, " .ci = ( . - . )), and/or unemployed (or = . , %ci = ij . - . _ people. in multtvanate analysis, after a full adjustment on gender, age, health status, health insura~ce, income, occupat n and tducation level, we observed significant associations between having no rfd and: ~arrtal and_ pare~t hood status (e.g. or single no kids/in couple+kids = . , %ci = ( . - . ()~ quality of relattonsh ps with neighbours (or bad/good= . , %ci = [ . - . )), and length of residence m the neighbourhood (with a dose/effect statistical relationship). . co clusion: gender, age, employment status, mariral and parenthood stat~s as well as ~e gh bourhood anchorage seem to be major predictors of having a rfd, even when um.versa! health i~sur ance has reduced most of financial barriers. in urban contexts, where residential migrattons and single lift (or family ruptures) are frequent, specific information may be conducted to encourage people to ket rfd. :tu~y tries to assess the health effects and costs and also analyse the availability and accessibility to health care for poor. . methods: data for this study was collected by a survey on households of the local community living near the factories and households where radiation hazard w~s n?~ present. ~~art from mor· bidity status and health expenditure, data was collected ~n access, a~ail~b .hty and eff c ency of healrh care. a discriminant analysis was done to identify the vanables that d scnmmate between the study and control group households in terms of health care pattern. a contingent valuation survey was also undertaken among the study group to find out the factors affecting their willingness to pay for health insurance and was analysed using logit model. results: the health costs and indebtedness in families of the study group was high as compared to control group households and this was mainly due to high health expenditure. the discriminant analysis showed that expenditure incurred by private hospital inpatient and outpatient expenditure were significant variables, which discriminated between the two types of households. the logit analysis showed !hat variables like indebtedness of households, better health care and presence of radiation induced illnesses were significant factors influencing willingness to pay for health insurance. the study showed that study group households were dependent on private sector to get better health care and there were problems with access and availability at the public sector. conclusion: the study found out that the quality of life of the local community is poor due to health effects of radiation and the burden of radiation induced illnesses are so high for them. there is an urgent need for government intervention in this matter. there is also a need for the public sector to be efficient to cater to the needs of the poor. a health insurance or other forms of support to these households will improve the quality for health care services, better and fast access to health care facilities and reduces the financial burden of the local fishing community. the prevalence of substance abuse is an increasing problem among low-income urban women in puerto rico. latina access to treatment may play an important role in remission from substance abuse. little is known, however, about latinas' access to drug treatment. further, the role of social capital in substance abuse treatment utilization is unknown. this study examines the relative roles of social capital and other factors in obtaining substance abuse treatment, in a three-wave longitudinal study of women ages - living in high-risk urban areas of puerto rico, the inner city latina drug using study (icldus). social capital is measured at the individual level and includes variables from social support and networks, familism, physical environment, and religion instruments of the icdus. the study also elucidates the role of treatment received during the study in bringing about changes in social capital. the theoretical framework used in exploring the utilization of substance abuse treatment is the social support approach to social capital. the research addresses three main questions: ( t) does social capital predict parti~ipating in treatment programs? ( ) does participation in drug treatment programs increase social capital?, and ( ) is there a significant difference among treatment modalities in affecting change in ~ial capital? the findings revealed no significant association between levels of social capital and gettmg treatment. also, women who received drug treatment did not increase their levels of social capital. the findings, however, revealed a number of significant predictors of social capital and receiving drug ~buse treatment. predictors of social capital at wave iii include employment status, total monthly mcoi:rie, and baseline social capital. predictors of receiving drug abuse treatment include perception of physical health and total amount of money spent on drugs. other different variables were associated to treatment receipt prior to the icldus study. no significant difference in changes of social capital was found among users of different treatment modalities. this research represents an initial attempt to elucidate the two-way relationship between social capital and substance abuse treatment. more work is necessary to unden~nd. ~e role of political forces that promote social inequalities in creating drug abuse problems and ava lab hty of treatment; the relationship between the benefits provided by current treatment poster sessions v sctrings and treatment-seeking behaviors; the paths of recovery; and the efficacy and effectiveness of the trtaanent. and alejandro jadad health professionals in urban centres must meet the challenge of providing equitable care to a population with diverse needs and abilities to access and use available services. within the canadian health care system, providers are time-pressured and ill-equipped to deal with patients who face barriers of poverty, literacy, language, culture and social isolation. directing patients to needed supportive care services is even more difficult than providing them with appropriate technical care. a large proportion of the population do not have equitable access to services and face major problems navigating complex systems. new approaches are needed to bridge across diverse populations and reach out to underserved patients most in need. the objective of this project was to develop an innovative program to help underserved cancer patients access, understand and use needed health and social services. it implemented and evaluated, a pilot intervention employing trained 'personal health coaches' to assist underserved patients from a variety of ethno-linguistic, socio economic and educational backgrounds to meet their supportive cancer care needs. the intervention was tested with a group of underserved cancer patients at the princess margaret hospital, toronto. personal coaches helped patients identify needs, access information, and use supportive care services. triangulation was used to compare and contrast multiple sources of quantitative and qualitative evaluation data provided by patients, personal health coaches, and health care providers to assess needs, barriers and the effectiveness of the coach program. many patients faced multiple barriers and had complex unmet needs. barriers of poverty and language were the easiest to detect. a formal, systematic method to identify and meet supportive care needs was not in place at the hospital. however, when patients were referred to the program, an overwhelming majority of participants were highly satisfied with the intervention. the service also appeared to have important implications for improved technical health care by ensuring attendance at appointments, arranging transportation and translation services, encouraging adherence to therapy and mitigating financial hardship -using existing community services. this intervention identified a new approach that was effective in helping very needy patients navigate health and social services systems. such programs hold potential to improve both emotional and physical health out· comes. since assistance from a coach at the right time can prevent crises, it can create efficiencies in the health system. the successful use of individuals who were not licensed health professionals for this purpose has implications for health manpower planning. needle exchange programs (neps) have been distributing harm reduction materials in toronto since . counterfit harm reduction program is a small project operated out of a community health centre in south-east toronto. the project is operated by a single full-time coordinator, one pan-rime mobile outreach worker and two peers who work a few hours each week. all of counterfit's staff, peers, and volunteers identify themselves as active illicit drug users. yet the program dis~rib utes more needles and safer crack using kits and serves more illicit drug u~rs t~an the comb ~e~ number of all neps in toronto. this presentation will discuss the reasons behind this success, .s~ f cally the extended hours of operation, delivery models, and the inclusion of an. extremely marg ~ahzed community in all aspects of program design, implementation and eva.luat ?n. ~ounterfit was recently evaluated by drs. peggy milson and carol strike, two leading ep dem olog st and researchers in the hiv and nep fields in toronto and below are some of their findings: "the program has experienced considerable success in delivering a high quality, accessible and well-used program .... the pro· gram has allowed (service users) to become active participants in providing. services to others and has resulted in true community development in the best sense. " ... counterf t has ~~n verr succe~sful attracting and retaining clients, developing an effective peer-based model an.d assisting chen~s ~ th a vast range of issues .... the program has become a model for harm red~ctmn progr~ms withm the province of ontario and beyond." in june , the association of ?ntano co~mumty heal~~ <:en· ires recognized counterfit's acheivements with the excellence m community health initiatives award. in kenya, health outcomes and the performance of government health service~ have det~riorated since the late s, trends which coincide with a period of severe resource constramts necessitated by macro-economic stabilization measures after the extreme neo-liberalism of the s. when the govern· ment withdrew from direct service provision as reform trends and donor advocacy suggested, how does it perform its new indirect role of managing relations with new direct health services providers in terms of regulating, enabling, and managing relations with these health services providers? in this paper therefore, we seek to investigate how healthcare access and availability in the slums of nairobi has been impacted upon by the government's withdrawal from direct health care provision. the methodology involved col· leering primary data by conducting field visits to health institutions located in the slum areas of kibera and korogocho in nairobi. purposive random sampling was utilized in this study because this sampling technique allowed the researcher(s) to select those health care seekers and providers who had the required information with respect to the objectives of the study. in-depth interviews using a semi-structured ques· tionnaire were administered ro key informants in health care institutions. this sought to explore ways in which the government and the private sector had responded and addressed in practical terms to new demands of health care provision following the structural adjustment programmes of the s. this was complemented by secondary literature review of publications and records of key governmental, bilateral and multilateral development partners in nairobi. the study notes a number of weaknesses especially of kenya's ministry of health to perform its expected roles such as managing user fee revenue and financial sustainability of health insurance systems. this changing face of health services provision in kenya there· fore creates a complex situation, which demands greater understanding of the roles of competition and choice, regulatory structures and models of financing in shaving the evolution of health services. we rec· ommend that the introduction of user fees, decentralization of service provision and contracting-out of non-clinical to private and voluntary agencies require a new management culture, and new and clear insri· tutional relationships. experience with private sector involvement in health projects underlines the need not only for innovative financial structures to deal with a multitude of contractual, political, market and risks, but also building credible structures to ensure that health services projects are environmentally responsive, socially sensitive, economically viable, and politically feasible. purpose: the purpose of this study is to examine the status of mammography screening utilization and its predictors among muslim women living in southern california. methods: we conducted a cross-sectional study that included women aged ::!: years. we col· leered data using a questionnaire in the primary language of the subjects. the questionnaire included questions on demography; practices of breast self-examination (bse) and clinical breast examination (cbe); utilization of mammography; and family history of breast cancer. bivariate and multiple logistic regression analyses were performed to estimate the odds ratios of mammography use as a function of demographic and other predictor variables. . results: among the women, % were married, % were - years old, and % had family h story of breast cancer. thirty-two percent of the participating women never practiced bse and % had not undergone cbe during the past two years. the data indicated that % of the women did not have mammography in the last two years. logistic regression analysis showed that age ( r= . , % confi· dcnc~ interval (cl)=l. - . ), having clinical breast examination ( r= . , % cl= . - . ), and practtce of self-breast examination ( r= . , % cl= . - . ), were strong predictors of mammography use . . conclusions: the data point to the need for intervention targeting muslim women to inform and motivate th.cm a~ut practices for early detection of breast cancer and screening. further studies are needed to investigate the factors associated with low utilization of mammography among muslim women population in california. we conducted a review of the scientific literature and° government documents to describe ditnational health care program "barrio adentro" (inside the neighborhood). we also conducted qualiurivt interviews with members of the local health committees in urban settings to descrihe the comm unity participation component of the program. rtsmlts: until recently, the venezuelan public health system was characterized by a lack or limited access w health care ( % of the population) and long waiting lists that amounted to denial of service. moit than half of the mds worked in the five wealthiest metropolitan areas of the country. jn the spring oi , a pilot program hired cuban mds to live in the slums of caracas to provide health care to piople who had previously been marginalized from social programs. the program underwent a massive expansion and in only two years , cuban and , venezuelan health care providers were working acmss the country. they provide a daily average of - medical consultations and home visits, c lly out neighborhood rounds, and deliver health prevention initiatives, including immunization programs. they also provide generic medicines at no cost to patients, which treat % of presenting ill-ij!m, barrio adentro aims to build , clinics (primary care), , diagnostic and rehabilitation ctnrres (secondary care), and upgrade the current hospital infrastructure (tertiary care). local health committees survey the community to identify needs and organize a variety of lobby groups to improve dit material conditions of the community. last year, barrio adentro conducted . times the medical visits conducted by the ministry of health. the philosophy of care follows an integrated approach where btalrh is related to housing, education, employment, sports, environment, and food security. conclusions: barrio adentro is a unique collaboration between low-middle income countries to provide health care to people who have been traditionally excluded from social programs. this program shows that it is possible to develop an effective international collaboration based on participatory democracy. low-income americans are at the greatest risk of being uninsured and often face multiple health concerns. this evaluation of the neighborhood health initiative (nh!), an organization which uses multiple programmatic approaches to meet the multiple health needs of clients, reflected the program's many activities and the clients' many service needs. nh! serves low-income, underserved, and hard-to-reach residents in the des moines enterprise community. multiple approaches (fourth-generation evaluation, grounded theory, strengths-and needs-based) and methods (staff and client interviews, concept mapping, observations, qualitative and quantitative analysis) were used to achieve that reflection. results indicate good targeting of residents in the zip code and positive findings in the way of health insurance coverage and reported unmet health needs of clients. program activities were found to match client nttds, validating the organization\'s assessment of clients. important components of nhi were the staff composition and that the organization had become part of both the formal and informal networks. nhi positioned as a link between the target population and local health and social sc:rvice agencies, working to connect residents with services and information as well as aid local agencies in reaching this underserved population. p - (c) welfare: definition by new york city maribeth gregory for an individual who resides in new york city, to obtain health insurance under the medicaid policy one must fall under certain criteria .. (new york city's welfare programs ) if the individual _is on ssi or earns equal to or less than $ per month, he is entitled to receive no more than $ , m resources. a family the size of two would need to earn less than $ per month to qualify for no greater than ss, worth of medicaid benefits. a family of three would qualify for $ , is they earned less than $ per month and so on. introduction: the vancouver gay communiry has a significant number of asian descendan!l. because of their double minority status of being gay and asian, many asian men who have sex with men (msm) are struggling with unique issues. dealing with racism in both mainstream society and the gay communiry, cultural differences, traditional family relations, and language challenges can be some of their everyday srruggles. however, culturally, sexually, and linguistically specific services for asian msm are very limited. a lack of availability and accessibiliry of culturally appropriate sexual health services isolates asian msm from mainstream society, the gay community, and their own cultural communities, deprives them of self-esteem, and endangers their sexual well-being. this research focuses on the qualita· tive narrative voices of asian msm who express their issues related to their sexualiry and the challenges of asking for help. by listening to their voices, practitioners can get ideas of what we are missing and how we need to intervene in order to reach asian msm and ensure their sexual health. methods: since many asian msm are very discreet, it is crucial to build up trust relationships between the researcher and asian msm in order to collect qualitative data. for this reason, a community based participatory research model was adopted by forming a six week discussion group for asian msm. in each group session, the researcher tape recorded the discussion, observed interactions among the participants, and analyzed the data by focusing on participants' personal thoughts, experiences, and emotions for given discussion topics. ra lts: many asian msm share challenges such as coping with a language barrier, cultural differ· ences for interpreting issues and problems, and westerncentrism when they approach existing sexual health services. moreover, because of their fear of being disclosed in their small ethnic communities, a lot of asian msm feel insecure about seeking sexual health services when their issues are related to their sexual orientation. conclflsion: sexual health services should contain multilingual and multicultural capacities to meet minority clients' needs. for asian msm, outreach may be a more effective way to provide them with accessible sexual health services since many asian msm are closeted and are therefore reluctant to approach the services. building a communiry for asian msm is also a significant step toward including them in healthcare services. a communiry-based panicipatory approach can help to build a community for asian msm since it creates a rrust relationship between a worker and clients. p - (c) identifying key techniques to sustain interpretation services for assisting newcomers isolated by linguistic and cultural barriers from accessing health services s. gopi krishna lntrodaetion: the greater toronto area (gta) is home to many newcomer immigrants and other vulnerable groups who can't access health resources due to linguistic, cultural and systemic barriers. linguistic and cultural issues are of special concern to suburbs like scarborough, which is home to thousands of newcomer immigrants and refugees lacking fluency in english. multilingual community ~nterpreter. service~ (mcis) is a non-profit social service organization mandated to provide high quality mterpretanon services. to help newcomers access health services, mcis partnered with the scarborough network of immigrant serving organizations (sniso) to recruit and train volunteer interpreters to accompany clienrs lacking fluency in english and interpret for them to access health services at various locati?ns, incl~~ing communiry ~c:-lth centres/social service agencies and hospitals. the model envisioned agencies recruin~ and mcis ~.mm.g and creating an online database of pooled interpreter resources. this da.tabase, acces& bl~ to all pama~~g ?rganization is to be maintained through administrative/member · ship fees to. be ~ d by each parnapanng organization. this paper analyzes the results of the project, defines and identifies suc:cases before providing a detailed analysis for the reasons for the success . . methods:. this ~per~ q~ntitative (i.e. client numben) and qualitative analysis (i.e. results of key •~ormant m~rv ews with semce ~sers and interpreters) to analyze the project development, training and mplementanon phases of the project. it then identifies the successes and failures through the afore· mentioned analysis. poster sessions vss resljts: the results of the analysis can be summarized as: • the program saw modest success both ia l?lllls of numbers of clients served as well as sustainability at various locations, except in the hospital iririog. o the success of the program rests strongly on the commitment of not just the volunteer interprmr, but on service users acknowledgments through providing transponation allowance, small honororia, letter of reference etc. • the hospital sustained the program better at the hospital due to the iolume and nature of the need, as well as innate capacity for managing and acknowledging volunceers. collc/llsion: it is possible to facilitate and sustain vulnerable newcomer immigrants access to health !ul'ices through the training and commitment of an interpreter volunteer core. acknowledging volunteer commitment is key to the sustenance of the project. this finding is important to immigration and health policy given the significant numbers of newcomer immigrants arriving in canada's urban communities. nity program was established in to provide support to people dying at home, especially those who were waiting for admission to the resi<lential hospice. with the advent of haart and corresponding challenges for people living with hiv/aids in the community, the community program has developed a unique case management approach. this model features an interdisciplinary team providing a clientdrivcn service. the case manager provides continuity of care to clients in a variety of settings both within and outside of the health care system. a case study is used to demonstrate how formal and informal networks of support facilitate efficient and appropriate resource utilization to promote client health. this case study demonstrates the value of consistent coordination with a client who has complex physical, spiritual, substance use and mental health needs. the authors will show how they liaised with the housing authority, police, social services as well as the family physician, clinic staff and a hospital emergtncy room to ensure this client did not fall between the cracks. tarek hussain recognition of the importance of community involvement and sectoral cooperation in health and !ocial services, formalized in alma-ata declaration in , was reinforced at riga meeting held at the mid·point between alma-ata and the year . then at the th anniversary of alma-ata declaration, ir was declared that 'primary health care is everybody's business'. health does not exist in isolation. health cannot be defined only as an outcome of 'medical care' but also as one of 'social action'; the responsibility of disease prevention and health promotion rests not only on governments, but also with don·govemmentorgan izations, the community, and individuals. the major accomplishment to date may be that rhere is growing realization in the health sector that community involvement is more than a political right-it is absolute necessary. lessons have learned during the implementation of disease-specific l'cltical programmes, such as cdd, ari, and epi; first, integrated and holistic approaches to childcare art needed, and second, the need for community involvement has become evident. imc! is a broad inte-gra ed strategy with an overall objective contributing to reducing child morbidity and mortality in developing countries. and one of the imci components, 'community !mci', which is now broadening ~s an entry point for child-focused community development initiatives. community jmcl/c~ ld health is ~n mtcgrated approach to the promotion of key family and community practices that have impact on: child growth and development, disease prevention, home care for sick, malnourished child~en, a.nd care-seekmg behavior and compliance with advice and treatment. the presentation addres~es, m brief, the ~evel opinent of community !mci, operational aspect of community/im cl, key strategies and tools ava la~le for implementation of c/imci. the paper draws some successful programme examples on working logether for imc! with the community in various countries which had substantial benefns on programme outcomes. p - t (c) healthy child screening: an innovative service initiative ann-marie marcolin and joyce allen . introduction: with mounting attention for creative and integrated models of c~re .that are populallon and community focused, the healthy child screening initiative achiev.es t~ese pnncipl~s and more! . • parkdale high park rotary (sponsorship) the heal~h ~h ld scree? ?g is a ~opl~-centred model of care. agency and professional sector-specific silos are ehmmated, ~rov dmg f~~ hes wit~ one-sto~ access to primary prevention services in a local school gym! children at nsk are rece vmg early mtervent n and appropriate referrals to the right care provider, at the right time a~d in t~e right place. further, with a complimentary focus on prevention, the program serves to keep at nsk children healthy. healthy child screening results: the service model is developed around four distinct phases: ) planned outreach; ) coordinated intake and registration; ) interdisciplinary screening; and ) targeted referral. since the fall and through six collaborative healthy child screenings children ranging in age from to have benefited from this unique service model of care. conclusion: the presentation will provide practical information on the development and implementation of the model. there will also be a focus on lessons learned in building community service provider-hospital relationships. according to statistics canada ( ) % of the toronto population was born outside of canada and % were new immigrants. immigrants often arrive in canada in superior health compared to the canadian born population, but they lose this health advantage over time. changes in immigrant health status over time may be attributed to a variety of factors including barriers to accessing and receiving care as well as limitations in the mainstream health service organizations and their approaches to health care delivery (hyman, ) . for example, immigrant women are less likely to receive pap tests, which places them at a greater risk for developing cervical cancer. similarly, immigrant women receive less mammography screening than their canadian counterparts. the immigrant women's health centre mobile health unit (mhu) was created as an alternative care delivery model to address the need for increased accessibility as well as culturally and linguistically appropriate reproductive health care. toronto western hospital and the immigrant women's health centre have formed a collaborative partnership which incorporates a primary care nurse practitioner and lay ethnocultural counselors providing care on the mhu. currently, a qualitative ethnonursing study is underway to understand the unique experiences of women using the mhu for their reproductive health care as well as the perspectives of the mhu health care providers. based on a literature review and preliminary findings from provider and participant interviews, the proposed presentation will address the themes of health status for immigrant and refugee women, accessibility issues as well strategies to improve their reproductive health care. we will discuss benefits as well as limitations to health care provision using this alternative service delivery model. michael carden, brian edlin, andrew talal, elizabeth getter, and marla shu lntrod.ction: to date most active drug users have not had access to treatment for hepatitis c virus (hcv) infection and substantial barriers continue to exist that interfere with treatment availability for this population. methods: active illicit drug users interested in pursuing hcv care and treatment were recruited in partnership w~th co~munity-based organizations (cbo's) in new york city. baseline data were collected on quahty of hfe, substance use patterns, depression, health care utilization, hcv health beliefs and other relev.ant variables. medical evaluations were conducted, including liver biopsy when indicated, an~ treatment ts ~ffered when no contraindications are present. participants also receive psychiatric evaluahons to determme the appropriateness of interferon treatment. renlts: fifteen individuals have been recruited to date and received an initial medical evaluation. the mean age was years and _the average age of initial heroin or cocaine use was . . eight ( %) ha~ been homeless at least once m the last months and s ( %) were homeless for most or all of this penod. fourteen ( %) had a history of injection drug use with the mean age at first injection being s frsewons v ,an. elrven persc.!ns ( %) reported inje~~ng .heroin or cocaine within the last days while the .wing four ( l'o) reported regular non-m ect on use of cocaine and street-obtained benzodiazepines. sijiy seven percent of the sample (n= ) reported ever being referred to hcv treatment while ( t % ) ftponeddiattreann~nt had been offered by~ ~e.dical provider. none had ever received a liver biopsy or araanent. most believed that hcv was a s gmf cant threat to their health ( %) and that there was a pm)dchance they would eventually die if their hepatitis c was not treated ( %). though individuals % believed that there was no cure for hcv, ( %) reported that they would initiate treatment if i was recommended by their doctor. thirteen ( %) had a current psychiatric diagnosis including «pmsion, anxiety disorder, schizophrenia, schizoaffective disorder, and borderline and antisocial persooaliry disorders. among eight individuals who had the beck depression inventory administered, the mean score was . . attendance rates were % ( / ) at scheduled medical and psychiatric ppointments and % ( / ) at liver biopsy. <andtuions: active drug users, despite experiencing multiple psycho-social problems, can be mgaged in hcv care using a multidisciplinary approach, but require intensive follow-up support. hcv aunnent of active drug users should not be dismissed. n- (c) antiretroviral therapy in mv infected infants: when to initiate therapy an african experience kingsley okonkwo, ademola adeyemo, israel sokeye, and nwaife umeike /""°""ction: as technology for early diagnosis of human immunodeficiency virus [hiv] improves, m to commence highly active antiretroviral therapy [haarn is yet to be fully evaluated. this prospective study describes our initial experience with early haart in hiv infected nigerian infants and rqions the outcome. we also analyzed the socioeconomic implications of early haart therapy in infants in the african setting. method: hiv infected infants were started on haart before months and followed up at mkly intervals.we monitored baseline and monthly cd . conclusion: initial results suggest early haart before months resulted. in improv~d out~ome in african children. treatment appears to be as effective as in developed counmes. in. a~nca as. m most developing countries with limited resources it is possible and effective to use haart m ~~ants if p~oper llloniroring facilities are available. however the occurrence of long-term drug related tox c ty and mk of emergence of resistant viral strains create need for further evaluation of haart in infants. background: most risk factors for cardiovascular disease (cvd) can be mitigated through ~th clinical interventions and lifestyle change. we used data from a telephone survey of new york city (nyc) adults to characterize health care access and healthy behavior among those with three or more cvd risk factors. methods: the study population included respondents to the nyc community health survey (n= , ) self-reporting~ of the following: smoking, diabetes, high cholesterol level, high blood pres· sure, body mass index > , and age > (males) or > (females) (n= , ). results: based on self-report, an estimated . , ( %) of nyc adults have~ or more cvd risk factors. this population is % male, % white, % black, and % with s years of education. most report good access to health care, indicated by having health insurance ( %), regular doctor ( %), their blood pressure checked within last months ( %), and their choles· terol checked within the past year ( % ). only % reported getting at least minutes of exercise ~ times per week and only % eating ~ servings of fruits and vegetables the previous day. among current smokers, % attempted to quit in past months, but only % used medication or counseling. implications: these data suggest that most nyc adults known to be at high risk for cvd have access to regular health care, but most do not engage in healthy lifestyle or, if they smoke, attempt effective quit strategies. more clinic-based and population-level interventions are needed to support lifestyle change among those at high risk of cvd. introduction: recently, much interest has been directed at "obesogenic" (obesity-promoting) (swinburn, egger & raza, ) built environments, and at geographic information systems (gis) as a tool for their exploration. a major geographical concept is accessibility, or the ease of moving from an origin to a destination point, which has been recently explored in several health promotion-related stud· ies. there are several methods of calculating accessibility to an urban feature, each with its own strengths, drawbacks and level of precision that can be applied to various health promotion research issues. the purpose of this paper is to describe, compare and contrast four common methods of calculating accessibility to urban amenities in terms of their utility to obesity-related health promotion research. practical and conceptual issues surrounding these methods are introduced and discussed with the intent of providing health promotion researchers with information useful for selecting the most appropria e accessibility method for their research goal~ ~ethod: this paper describes methodological insights from two studies, both of which assessed the neighbourhood-level accessibility of fast-food establishments in edmonton, canada -one which used a relatively simple coverage method and one which used a more complex minimum cos method. res.its: both methods of calculating accessibility revealed similar patterns of high and low access to fast-food outlets. however, a major drawback of both methods is that they assume the characteristics of the a~e~ities and of the populations using them are all the same, and are static. the gravity potential method is introduced as an alternative, since it is ·capable of factoring in measures of quality and choice. a n~mber of conceptual and pr~ctical iss~es, illustrated by the example of situational influences on food choice, make the use of the gravity potential model unwieldy for health promotion research into sociallydetermined conditions such as obesity. co.nclusions: i~ ~ommended that geographical approaches be used in partnership with, or as a foun~ation for, ~admonal exploratory methodologies such as group interviews or other forms of commumty consultation that are more inclusive and representative of the populations of interest. qilhl in los angeles county ,,..ia shaheen, richard casey, fernando cardenas, holman arthurs, and richard baker ~the retinomax autorefractor has been used for vision screening of preschool age childien. ir bas been suggested to be used and test school age children but not been validated in this age poup. ob;taiw: to compare the results of retinomax autorefractor with findings from a comprehensive i!' examination using wet retinoscopy for refractive error. mllhods: children - years old recruited from elementary schools at los angeles county were iaml with snellen's chart and the retinomax autorefractor and bad comprehensive eye examination with dilation. the proportion of children with abnormal eye examination as well as diesensitiviry and specificity of the screening tools using retinomax autorefractor alone and in combinalion wirh snellen's chart. results of the children enrolled in the study (average age= . ± . years; age range, - years), ?% had abnormal eye examination using retinoscopy with dilation. for the lerinomax, the sensitivity was % ( % confidence interval [ci] %- %), and the specificity was % ( % ci, %- o/o). simultaneous testing using snellen's chart and retinomax resulted in gain in sitiviry ( %, % cl= , ), and loss in specificity ( %, % cl= %- %). the study showed that screening school age children with retinomax autorefractor could identify most cases with abnormal vision but would be associated with many false-positive results. simuhaneous resting using snellen's chart and retinomax maximize the case finding but with very low specificiry. mdhotjs: a language-stratified, random sample of members of the college of family physicians of canada received a confidential survey. the questionnaire collected data on socio-demographic characteristics, medical training, practice type, setting and hcv-related care practices. the self-adminisratd questionnaire was also made available to participants for completion on the internet. batdti: response proportion was %. median age was years ( % female) and the proporlionoffrench questionnaires was %. approximately % had completed family medicine residency lllining in canada; median year of training completion was . sixty-seven percent, % and % work in private offices/clinics, community hospitals and emergency departments, respectively. regarding ~practices, % had ever requested a hcv test and % of physicians had screened for hcv iafrction in rhe past months· median number of tests was . while % reported having no hcv-uaed patients in their practic~, % had - hcv-infected patients. regarding the level of hcv care provided, . % provide ongoing advanced hcv care including treatment and dose monitoring for ctmduions: in this sample of canadian family physicians, most had pro~ided hcv screening. to •least one patient in the past year. less than half had - hcv-infected patients and % provide ~:relared care the role of socio-demographic factors, medical training as wel_i as hcv ca~e percep-lldas rhe provision of appropriate hcv screening will be examined and described at the time of the canference. ' - (c) healthcare services: the context of nepal meen poudyal chhetri """ tl.ction healthcare service is related with the human rights and fundamental righ~ of the ci~ ciaaiuntry. however, the growing demand foi health care services, quality heal~care service, accessib b~ id die mass population and paucity of funds are the different but interrelated issues to .be ~ddressed. m nepat. n view of this context, public health sector in nepal is among other sectors, which is struggling -.i for scarce resources. . . . nepal, the problems in the field of healthcare servic~s do not bnut ~o the. paucity of faads and resources only, but there are other problems like: rural -urban imbalance, regional unbalance, poster sessio~ f the ll ·m ·ted resources poor healthcare services, inequity and inaccessibility of the poor management o , . poor people of the rural, remote and hilly areas for the healthcare services and so on.. . . . · . i f ct the best resource allocation is the one that max m zes t e sum o m ivi ua s u · ea t services. n a , · h d' ·b · · · h . ·t effi.ciency and efficient management are correlated. it might be t e re istn utmn of mes. ence, equi y, . . . . . income or redistribution of services. moreover, maximizanon of available resources, qua tty healthcare services and efficient management of them are the very important and necessary tools and techmques to meet the growing demand and quality healthcare services in nepal. p - (a) an jn-depth analysis of medical detox clients to assist in evidence based decision making xin li, huiying sun, ajay puri, david marsh, and aslam anis introduction: problematic substance use represents an ever-increasing public health challenge. in the vancouver coastal health (vch) region, there are more than , individuals having some probability of drug or alcohol dependence. to accommodate this potential demand for addiction related services, vch provides various services and treatment, including four levels of withdrawal management services (wms). clients seeking wms are screened and referred to appropriate services through a central telephone intake service (access i). the present study seeks to rigorously evaluate one of the services, vancouver detox, a medically monitored -bed residential detox facility, and its clients. doing so will allow decision makers to utilize evidence based decision-making in order to improve the accessibility and efficiency of wms, and therefore, the health of these clients. methods: we extract one-year data (october , -september , from an efficient and comprehensive database. the occupancy rate of the detox centre along with the clients' wait time for service and length of stay (los) are calculated. in addition, the effect of seasonality on these variables and the impact of the once per month welfare check issuance on the occupancy rate are also evaluated. results: among the clients (median age , % male) who were referred by access! to vancouver detox over the one-year period, were admitted. the majority ( %) of those who are not admitted are either lost to follow up (i.e., clients not having a fixed address or telephone) or declined service at time of callback. the median wait time was day [q -ql: - ], the median los was days iq -qt: - ], and the average bed occupancy rate was %. however, during the threeday welfare check issue period the occupancy rate was lower compared to the other days of the year % vs. %, p conclusion: our analysis indicates that there was a relatively short wait time at vancouver detox, however % of the potential clients were not served. in addition, the occupancy rate declined during the welfare check issuance period and during the summer. this suggests that accessibility and efficiency at vancouver detox could be improved by specifically addressing these factors. background: intimate partner violence (ipv) is associated with acute and chronic physical and men· tal health outcomes for women resulting in greater use of health services. yet, a vast literature attests to cultural variations in perceptions of health and help-seeking behaviour. fewer studies have examined differences in perceptions of ipv among women from ethnocultural communities. the recognition, definition, and understanding of ipv, as well as the language used to describe these experiences, may be different in these communities. as such, a woman's response, including whether or not to disclose or seek help, may vary according to her understanding of the problem. methods: this pilot study explores the influence of cultural factors on perceptions of and responses to ipv among canadian born and immigrant young women. in-depth focus group interviews were con· ducted with women, aged to years, living in toronto. open-ended and semi-structured interview questions were designed to elicit information regarding how young women socially construct jpv and where they would go to receive help. interviews were transcribed, then read and independently coded by the research team. codes were compared and disagreements resolved. qualitative software qsr n was used to assist with data management. . ruu~ts_: res~nses_abo~t what constitutes ipv were similar across the study groups. when considering specific ab.us ve ~ tuanons and types of relationships, participants held fairly relativistic views about ipv, especially with regard to help-seeking behaviour. cultural differences in beliefs about normaive m;ile/femal~ relations. familial.roles, and customs governing acceptable behaviours influenced partictpants perceptions about what n ght be helpful to abused women. interview data highlight the social l ter srnfons v suucrural _impact these factors ha:e on you?g women and provide details regarding the dynamics of cibnocultur~ m~uences on help-~eekmg behav ur: t~e ro~e of such factors such as gender inequality within rtlaoo?sh ps and t_he ~erce ved degree of ~oc al solat on and support nerworks are highlighted. collc~ the~ findmgs unde~score the _ mporta_nc_e of understanding cultural variations in percrprions of ipv ~ relanon to ~elp-seekmg beha~ ':'ur. th s_mformation is critical for health professionals iodiey may connnue developmg culturally sensmve practices, including screening guidelines and protorol s. ln addition, _this study demonstr~tes that focus group interviews are valuable for engaging young romen in discussions about ipv, helpmg them to 'name' their experiences, and consider sources of help when warranted. p -s (a) health problems and health care use of young drug users in amsterdam .wieke krol, evelien van geffen, angela buchholz, esther welp, erik van ameijden, and maria prins / trod ction: recent advances in health care and drug treatment have improved the health of populations with special social and health care needs, such as drug users. however, still a substantial number dots not have access to the type of services required to improve their health status. in the netherlands, tspccially young adult drug users (yad) whose primary drug is cocaine might have limited access to drugrreatment services. in this study we examined the history and current use of (drug associated) treatmmt services, the determinants for loss of contact, and the current health care needs in the young drug mm amsterdam study (yodam). methods: yodam started in and is embedded in the amsterdam cohort study among drug mm. data were derived from y ad aged < years who had used cocaine, heroin, ampheramines and i or methadone at least days a week during the months prior to enrolment. res lts:of yao, median age was years (range: - years), % was male and % had dutch nationality at enrolment. nearly all participants ( %) reported a history of contact with drug llt.lnnent services (methadone maintenance, rehabilitation clinics and judicial treatment), mental health car? (ambulant mental care and psychiatric hospital) or general treatment services (day-care, night-care, hdp for living arrangements, work and finance). however, only % reported contact in the past six l!xlllths. this figure was similar in the first and second follow-up visit. among y ad who reported no current contact with the health care system, % would like to have contact with general treatment serl' icts. among participants who have never had contact with drug treatment services, % used primarily cocaine compared with % and % among those who reported past or current contact, respectively. saied on the addiction severity index, % reported at least one mental health problem in the past days, but only % had current contact with mental health services. concl sion: results from this study among young adult drug users show that despite a high contact rm with health care providers, the health care system seems to lose contact with yao. since % indicatt the need of general treatment services, especially for arranging house and living conditions, health m services that effectively integrate general health care with drug treatment services and mental health care might be more successful to keep contact with young cocaine users. mtthods: respondents included adults aged and over who met dsm-iv diagn?snc criteria for an anxiety or depressive disorder in the past months. we performed two sets of logisnc regressmns. thtdichotomous dependent variables for each of the regressions indicated whether rhe respondenr_vis-ud a psychiatrist, psychologist, family physician or social worker in the _past_ months. no relationship for income. there was no significant interaction between educatmn an mco~:· r: ::or respondents with at least a high school education to seek help ~rom any of the four servic p were almost twice that for respondents who had not completed high school. th . d ec of analyses found che associacion becween educacion and use of md-provided care e secon s · · be d · · ·f· ly ·n che low income group for non-md care, the assoc anon cween e ucatlon and was s gm icant on -· . . . . use of social workers was significant in both income groups, but significant only for use of psychologists in che high-income group. . . . conclusion: we found differences in healch service use by education level. ind v duals who have nor compleced high school appeared co use less mental he~lt~ servi~es provided ~y psyc~iatrists, psycholo· gists, family physicians and social workers. we found limited e.v dence _suggesting the influence of educa· tion on service use varies according to income and type of service provider. results suggesc there may be a need to develop and evaluate progr~ms.designe~ to deliver targeted services to consumers who have noc completed high school. further quahtanve studies about the expen· ence of individuals with low education are needed to clarify whether education's relationship with ser· vice use is provider or consumer driven, and to disentangle the interrelated influences of income and education. system for homeless, hiv-infected patients in nyc? nancy sahler, chinazo cunningham, and kathryn anastos introduction: racial/ethnic disparities in access to health care have been consistently documented. one potential reason for disparities is that the cultural distance between minority patients and their providers discourage chese patients from seeking and continuing care. many institucions have incorporated cultural compecency craining and culturally sensicive models of health care delivery, hoping co encourage better relacionships becween patients and providers, more posicive views about the health care system, and, ulcimacely, improved health outcomes for minority patients. the current scudy tests whether cultural distance between physicians and patients, measured by racial discordance, predicts poorer patient attitudes about their providers and the health care system in a severely disadvantaged hiv-infected population in new york city that typically reports inconsistent patterns of health care. methods: we collected data from unscably housed black and latino/a people with hiv who reported having a regular health care provider. we asked them to report on their attitudes about their provider and the health care system using validated instruments. subjects were categorized as being racially "concordant" or "discordant" with their providers, and attitudes of these two groups were compared. results: the sample consisted of ( %) black and ( %) latino/a people, who reported having ( %) black physicians, ( %) latino/a physicians, ( %) white physicians, and ( %) physicians of another/unknown race/ethnicity. overall, ( %) subjects had physicians of a different race/ethnicity than their own. racial discordance did not predict negative attitudes about rela· tionship with providers: the mean rating of a i-item trust in provider scale (lo=high and o=low) was . for both concordant and discordant groups, and the mean score in -icem relationship with provider scale ( =high and !=low) was . for both groups. however discordance was significantly associated with distrust in che health care syscem: che mean score on a -icem scale ( =high discrust and l=low distrust) was . for discordant group and . for che concordant group (t= . , p= . ). we further explored these patterns separacely in black and lacino/a subgroups, and using different strategies ro conceptualize racial/ethic discordance. conclusions: in this sample of unscably housed black and latino/a people who receive hiv care in new york city, having a physician from the same racial/ethnic background may be less important for developing a positive doctor-patient relationship than for helping the patients to dispel fear and distrust about the health care system as a whole. we discuss the policy implications of these findings. ilene hyman and samuel noh . .abstract objectiw: this study examines patterns of mental healthcare utilization among ethiopian mm grants living in toronto. methods: a probability sample of ethiopian adults ( years and older) completed structured face-to-face interviews. variables ... define, especially who are non-health care providers. plan of analysis. results: approximately % of respondents received memal health services from mainstream healthcare providers and % consulted non-healthcare professionals. of those who sought mental health services from mainstream healthcare providers, . % saw family physicians, . % visited a psychiatrist. and . % consulted other healthcare providers. compared with males, a significantly higher proportion gsfer sessions v ri ftlnales consulted non-healthcare_ professionals for emotional or mental health problems (p< . ). tlbile ethiopian's overall use of mamstream healthcare services for emotional problems ( %) did not prlydiffer from the rate ( %) of the general population of ontario, only a small proportion ( . %) rjerhiopians with mental health needs used services from mainstream healthcare providers. of these, !oj% received family physicians' services, . % visited a psychiatrist, and . % consulted other healthll/c providers. our data also suggested that ethiopian immigrants were more likely to consult tradioooal healers than health professionals for emotional or mental health problems ( . % vs. . % ). our bivariate analyses found the number of somatic symptoms and stressful life events to be associated with an increased use of medical services and the presence of a mental disorder to be associated with a dfcreased use of medical services for emotional problems. however, using multivariate methods, only die number of somatic symptoms remained significantly associated with use of medical services for emooonal problems. diu#ssion: study findings suggest that there is a need for ethnic-specific and culturally-appropriate mrcrvention programs to help ethiopian immigrants and refugees with mental health needs. since there ~a strong association between somatic symptoms and the use family physicians' services, there appears robe a critical role for community-based family physicians to detect potential mental health problems among their ethiopian patients, and to provide appropriate treatment and/or referral. the authors acknowledge the centre of excellence for research in immigration and settlement (ceris) in toronto and canadian heritage who provided funding for the study. we also acknowledge linn clark whose editorial work has improved significantly the quality of this manuscript. we want to thank all the participants of the study, and the ethiopian community leaders without whose honest contributions the present study would have not been possible. this paper addresses the impact of the rationalization of health-care services on the clinical decision-making of emergency physicians in two urban hospital emergency departments in atlantic canada. using the combined strategies of observational analysis and in-depth interviewing, this study provides a qualitative understanding of how physicians and, by extension, patients are impacred by the increasing ancmpts to make health-care both more efficient and cost-effective. such attempts have resulted in significantly compromised access to primary care within the community. as a consequence, patients are, out of necessity, inappropriately relying upon emergency departments for primary care services as well as access to specialty services. within the hospital, rationalization has resulted in bed closures and severely rmricted access to in-patient services. emergency physicians and their patients are in a tenuous position having many needs but few resources. furthermore, in response to demands for greater accountability, physicians have also adopted rationality in the form of evidence-based medicine. ultimately, ho~ever, rationality whether imposed upon, or adopted by, the profession significantly undermines physu.: ans' ability to make decisions in the best interests of their patients. johnjasek, gretchen van wye, and bonnie kerker introduction: hispanics comprise an increasing proportion of th.e new york city (nyc) populanon !currently about %). like males in the general population, h spamc males (hm) have a lower prrval,nce of healthcare utilization than females. however, they face additional access barriers such as bnguage differences and high rates of uninsurance. they also bear a heavy burden of health problems lllehasobesity and hiv/aids. this paper examines patterns of healthcare access and ut hzat on by hm compared to other nyc adults and identifies key areas for intervention. . . . and older are significantly lower than the nhm popu anon . v. . , p<. ), though hi\' screening and immunizations are comparable between the two groups. conclusion: findings suggest that hm have less access t? healthcare than hf or nhm. hown r, hm ble to obtain certain discrete medical services as easily as other groups, perhapsdueto!rtor are a hm. i i . subsidized programs. for other services, utilization among s ower. mprovmg acc~tocareinthis group will help ensure routine, quality care, which can lead to a greater use of prevennve services iii! thus bener health outcomes. introduction: cancer registry is considered as one of the most important issues in cancer epidemiology and prevention. bias or under-reporting of cancer cases can affect the accuracy of the results of epidemiological studies and control programs. the aim of this study was to assess the reliability of the regional cancer report in a relatively small province (yasuj) with almost all facilities needed for c llcll diagnosis and treatment. methods: finding the total number of cancer cases we reviewed records of all patients diagnoicd with cancer (icd - ) and registered in any hospital or pathology centre from until i n yasuj and all ( ) surrounding provinces. results: of patients who were originally residents of yasui province, . % wereaccoulll!d for yasuj province. the proportion varies according to the type of cancer, for exarnplecancetsofdiglstive system, skin and breast were more frequently reported by yasuj's health facilities whereas cancmoi blood, brain and bone were mostly reported by neighbouring provinces. the remaining cases ( . % were diagnosed, treated and recorded by neighbouring provinces as their incident cases. this is partly because of the fact that patients seek medical services from other provinces as they believed that the facil. ities are offered by more experienced and higher quality stuffs and their relative's or temporary acooiii' modation addresses were reported as their place of residence. conclusion: measuring the spatial incidence of cancer according to the location of report ortht current address affected the spatial statistics of cancer. to correct this problem recording the permanm! address of diagnosed cases is important. p - (c). providing primary healthcare to a disadvantaged population at a university-run commumty healthcare facility tracey rickards the. c:ommuni~y .h~alth ~linic (chc) is a university sponsored nurse-managed primary bealthwt (p~c:l clime. the clm c is an innovative model of healthcare delivery in canada that has integrated tht principles of phc ser · · h' . vices wit ma community development framework. it serves to provide access to phc services for members of th · · illi · dru is ii be . . e community, particularly the poor and those who use or gs, we mg a service-learning facil'ty f d · · · · · · d rionll h . . .,m.:. · t · . meet c ient nee s. chmc nursing and social work staff and srudents r·--· ipa em various phc activities and h .l.hont" less i . f . outreac services in the local shelters and on the streels to'"" popu auon o fredericton as well th chc · model iii fosterin an on oi : . • e promotes and supports a harm reduction . · local d!or an~ h ng ~art:ersh p with aids new brunswick and their needle exchange program, w tha ing condoms and :xu:t h:~~~e e~aint~nance therapy clients, and with the clie~ts themselves ~_r; benefits of receiving health f ucation, a place to shower, and a small clothing and food oai~· care rom a nurse p · · d d · --""~'i"· are evidenced in th r research that involved needsaans mvo ves clients, staff, and students. to date the chc has unacn- · sessment/enviro i . d ; •• '"""" ll eva uanon. the clinic has also e . d nmenta scan, cost-benefit analysis, an on-go...,, "".'i'~ facility and compassionate lea x~mme the model of care delivery' focusing on nursing roles wi~ cj rmng among students. finally, the clinic strives to share the resu•p v . -arch with the community in which it provides service by distributing a bi-monthly newsletter, and plllicipating in in-services and educational sessions in a variety of situations. the plan for the future is coolinued research and the use of evidence-based practice in order to guide the staff in choosing how much n~ primary healthcare services to marginalized populations will be provided. n- (c) tuming up the volume: marginalized women's health concerns tckla hendrickson and betty jane richmond bdrotbu:tion: the marginalization of urban women due to socio-economic status and other determinants negatively affects their health and that of their families. this undermines the overall vitaliry of urban communities. for example, regarding access to primary health care, women of lower economic surus and education levels are less likely to be screened for breast and cervical cancer. what is not as widely reported is how marginalized urban women in ontario understand and articulate their lack of access to health care, how they attribute this, and the solutions that they offer. this paper reports on the rnults of the ontario women's health network (owhn) focus group project highlighting urban women's concerns and suggestions regarding access to health care. it also raises larger issues about urban health, dual-purpose focus group design, community-based research and health planning processes. mdhods: focus group methodology was used to facilitate a total of discussions with urban and rural women across ontario from to . the women were invited to participate by local women's and health agencies and represented a range of ages, incomes, and access issues. discussions focussed on women's current health concerns, access to health care, and information needs. results were analyzed using grounded theory. the focus groups departed from traditional focus group research goals and had two purposes: ) data collection and dissemination (representation of women's voices), and ) fostering closer social ties between women, local agencies, and owhn. the paper provides a discussion and rationale for a dual approach. rax/ts: the results confirm current research on women's health access in women's own voices: urban women report difficulty finding responsive doctors, accessing helpful information such as visual aids in doctors' offices, and prohibitive prescription costs, in contrast with rural women's key concern of finding a family doctor. the research suggests that women's health focus groups can address access issues by helping women to network and initiate collective solutions. the study shows that marginalized urban women are articulate about their health conctrns and those of their families, often understanding them in larger socio-economic frameworks; howtver, women need greater access to primary care and women-friendly information in more languages and in places that they go for other purposes. it is crucial that urban health planning processes consult directly with women as key health care managers, and turn up the volume on marginalized women's voices. women: an evaluation of awareness, attitudes and beliefs introduction: nigeria has one of the highest rates of human immunodeficiency virus ihivi seroprrvalence in the world. as in most developing countries vertical transmission from mother to child account for most hiv infection in nigerian children. the purpose of this study was ro. determine the awareness, attitudes and beliefs of pregnant nigerian women towards voluntary counseling and testing ivct! for hiv. mnbod: a pre-tested questionnaire was used to survey a cross section '.>f. pregnant women ~t (lrlleral antenatal clinics in awka, nigeria. data was reviewed based on willingness to ~c~ept or re ect vct and the reasons for disapproval. knowledge of hiv infection, routes of hiv transm ssmn and ant rnroviral therapy iart) was evaluated. hsults: % of the women had good knowledge of hiv, i % had fair knowledge while . % had poor knowledge of hiv infection. % of the women were not aware of the association of hreast milk feeding and transmission of hiv to their babies. majority of the women % approved v~t while % disapproved vct, % of those who approved said it was because vct could ~educe risk of rransmission of hiv to their babies. all respondents, % who accepted vc.i ~ere willing to be tnted if results are kept confidential only % accepted to be tested if vc.t results w. be s~ared w .th pinner and relatives % attributed their refusal to the effect it may have on their marriage whale '-gave the social 'and cultural stigmatization associated with hiv infection for their r~fusal.s % wall accept vct if they will be tested at the same time with their partners. ~ of ~omen wall pref~r to breast feed even if they tested positive to hiv. women with a higher education diploma were times v more likely to accept vct. knowledge of art for hiv infected pregnant women as a means of pre. vention of maternal to child transmission [pmtct) was generally poor, % of respondents wm aware of art in pregnancy. conclusion: the acceptance of vct by pregnant women seems to depend on their understanding that vct has proven benefits for their unborn child. socio-cultur al factors such as stigmatizationof hiv positive individuals appears to be the maj_or impedi~ent towards widespread acceptanee of ycr in nigeria. involvemen t of male partners may mpro~e attitudes t~wa~ds vct:the developmentofm novative health education strategies is essential to provide women with mformanon as regards the benefits of vct and other means of pmtct. p - (c) ethnic health care advisors in information centers on health care and welfare in four districts of amsterdam arlette hesselink, karien stronks, and arnoud verhoeff introduction : in amsterdam, migrants report a "worse actual health and a lower use of health care services than the native dutch population. this difference might be partly caused by problems migrants have with the dutch language and health care and welfare system. to support migrants finding their way through this system, in four districts in amsterdam information centers on health care and welfare were developed in which ethnic health care advisors were employed. their main task is to provide infor· mation to individuals or groups in order to bridge the gap between migrants and health care providers. methods: the implementat ion of the centers is evaluated using a process evaluation in order to give inside in the factors hampering and promoting the implementat ion. information is gathered using reports, attending meetings of local steering groups, and by semi-structu red interviews with persons (in)directly involved in the implementat ion of the centers. in addition, all individual and groupcontaets of the health care advisors are registered extensively. results: since four information centers, employing ethnic health care advisors, are implemented. the ethnicity of the health care advisors corresponds to the main migrant groups in the different districts (e.g. moroccan, turkeys, surinamese and african). depending on the local steering groups, the focus of the activities of the health care advisors in the centers varies. in total, around individual and group educational sessions have been registered since the start. most participants were positive about the individual and group sessions. the number of clients and type of questions asked depend highly on the location of the centers (e.g. as part of a welfare centre or as part of a housing corporation). in all districts implementa tion was hampered by lack of ongoing commitment of parties involved (e.g. health care providers, migrant organization s) and lack of integration with existing health care and welfare facilities. discussion: the migrant health advisors seem to have an important role in providing information on health and welfare to migrant clients, and therefore contribute in bridging the gap between migrants and professionals in health care and welfare. however, the lack of integration of the centers with the existing health care and welfare facilities in the different districts hampers further implementation . therefore, in most districts the information centres will be closed down as independent facilicities in the near future, and efforts are made to better connect the position of migrant health advisor in existing facilities. the who report ranks the philippines as ninth among countries with a high tb prevalence. about a fourth of the country's population is infected, with majority of cases coming from the lower socioeconomic segments of the community. metro manila is not only the economic and political capital of the philippines but also the site of major universities and educational institutions. initial interviews with the school's clinicians have established the need to come up with treatment guidelines and protocols for students and personnel when tb is diagnosed. these cases are often identified during annual physical examinations as part of the school's requirements. in many instances, students and personnel diagnosed with tb are referred to private physicians where they are often lost to follow-up and may have failure of treatment due to un monitored self-administered therapy. this practice ignores the school clinic's great potential as a tb treatment partner. through its single practice network (spn) initiative, the philippine tuberculosis initiatives for the private sector (philippine tips), has established a model wherein school clinics serve as satellite treatment partners of larger clinics in the delivery of the directly observed treatment, short course (dots) protocol. this "treatment at the source" allows school-based patients to get their free government-suppl ied tb medicines from the clinic each day. it also cancels out the difficulty in accessing medicines through the old model where the patient has to go to the larger clinic outside his/her school to get treatment. the model also enables the clinic to monitor the treatment progress of the student and assumes more responsibility over their health. this experience illustrates how social justice in health could be achieved from means other than fund generation. the harnessing of existing health service providers in urban communities through standardized models of treatment delivery increases the probability of treatment success, not only for tb but for other conditions as well. p - (c) voices for vulnerable populations: communalities across cbpr using qualitative methods martha ann carey, aja lesh, jo-ellen asbury, and mickey smith introduction: providing an opportunity to include, in all stages of health studies, the perspectives and experiences of vulnerable and marginalized populations is increasingly being recognized as a necessary component in uncovering new solutions to issues in health care. qualitative methods, especially focus groups, have been used to understand the perspectives and needs of community members and clinical staff in the development of program theory, process evaluation and refinement of interventions, and for understanding and interpreting results. however, little guidance is available for the optimal use of such information. methods: this presentation will draw on diverse experiences with children and their families in an asthma program in california, a preschool latino population in southern california, a small city afterschool prevention program for children in ohio, hiv/aids military personnel across all branches of the service in the united states, and methadone clinic clients in the south bronx in new york city. focus groups were used to elicit information from community members who would not usually have input into problem definitions and solutions. using a fairly common approach, thematic analysis as adapted from grounded theory, was used to identify concerns in each study. next we looked across these studies, in a meta-synthesis approach, to examine communalities in what was learned and in how information was used in program development and refinement. results: while the purposes and populations were diverse, and the type of concerns and the reporting of results varied, the conceptual framework that guided the planning and implementation of each study was similar, which led to a similar data analysis approach. we will briefly present the results of each study, and in more depth we will describe the communalities and how they were generated. conclusions: while some useful guidance for planning future studies of community based research was gained by looking across these diverse studies, it would be useful to pursue a broader examination of the range of populations and purposes to more fully develop guidance. background: the majority of studies examining the relationship between residential environments and cardiovascular disease have used census derived measures of neighborhood ses. there is a need to identify specific features of neighborhoods relevant to cardiovascular disease risk. we aim to ) develop methods· data on neighborhood conditions were collected from a telephone survey of s, fesi· dents in balth:.ore, md; forsyth county, nc; and new york, ny. a sample of of the i.ni~~l l'elpondents was re-interviewed - weeks after the initial interview t~ measure the tes~-~etest rebab ~ ty of ~e neighborhood scales. information was collected across seven ~e ghborho~ cond ~ons (aesth~~ ~uah~, walking environment, availability of healthy foods, safety, violence, social cohesion, and acnvmes with neighbors). neighborhoods were defined as census tracts or homogen~us census tra~ clusters. ~sycho metric properties.of the neighborhood scales were accessed by ca~cu~~.ng chronba~h s alpha~ (mtemal consistency) and intraclass correlation coefficients (test-r~test reliabilmes) .. pear~n s .corre~anons were calculated to test for associations between indicators of neighborhood ses (tncludmg d mens ons of race/ ethnic composition, family structure, housing, area crowding, residential stability, education, employment, occupation, and income/wealth) and our seven neighborhood scales. . chronbach's alphas ranged from . (walking environment) to . (violence). intraclass correlations ranged from . (waling environment) to . (safety) and wer~ high~~~ . ~ for ~urout of the seven neighborhood dimensions. our neighborhood scales (excluding achv hes with neighbors) were consistently correlated with commonly used census derived indicators of neighborhood ses. the results suggest that neighborhood attributes can be reliably measured. further development of such scales will improve our understanding of neighborhood conditions and their importance to health. childhood to young adulthood in a national u.s. sample jen jen chang lntrodfldion: prior studies indicate higher risk of substance use in children of depressed mothers, but no prior studies have followed up the offspring from childhood into adulthood to obtain more precise estimates of risk. this study aimed to examine the association between early exposure to maternal depl'elsive symptoms (mds) and offspring substance use across time in childhood, adolescence, and young adulthood. methods: data were obtained from the national longitudinal survey of youth. the study sample includes , mother-child/young adult dyads interviewed biennially between and with children aged to years old at baseline. data were gathered using a computer-assisted personal interview method. mds were measured in using the center for epidemiologic studies depression scale. offspring substance use was assessed biennially between and . logistic and passion regression models with generalized estimation equation approach was used for parameter estimates to account for possible correlations among repeated measures in a longitudinal study. rnlllta: most mothers in the study sample were whites ( %), urban residents ( %), had a mean age of years with at least a high school degree ( %). the mean child age at baseline was years old. offspring cigarette and alcohol use increased monotonically across childhood, adolescence, and young adulthood. differential risk of substance use by gender was observed. early exposure to mds was associated with increased risk of cigarette (adjusted odds ratio (aor) = . , % confidence interval ( ): . , . ) and marijuana use (aor = . , % ci: . , . ), but not with alcohol use across childhood, adolescence, and young adulthood, controlling for a child's characteristics, socioeconomic status, ~ligiosity, maternal drug use, and father's involvement. among the covariates, higher levels of father's mvolvement condluion: results from this study confirm previous suggestions that maternal depressive symptoms are associated with adverse child development. findings from the present study on early life experi-e~ce have the potential to inform valuable prevention programs for problem substance use before disturbances become severe and therefore, typically, much more difficult to ameliorate effectively. the ~act (~r-city men~ health study predicting filv/aids, club and other drug transi-b~) study a multi-level study aimed at determining the association between features of the urban enyjronment mental health, drug use, and risky sexual behaviors. the study is randomly sampling foster sessions v neighborhood residents and assessing the relations between characteristics of ethnographically defined urban neighborhoods and the health outcomes of interest. a limitation of existing systematic methods for evaluating the physical and social environments of urban neighborhoods is that they are expensive and time-consuming, therefore limiting the number of times such assessments can be conducted. this is particularly problematic for multi-year studies, where neighborhoods may change as a result of seasonality, gentrification, municipal projects, immigration and the like. therefore, we developed a simpler neighborhood assessment scale that systematically assessed the physical and social environment of urban neighborhoods. the impact neighborhood evaluation scale was developed based on existing and validated instruments, including the new york city housing and vacancy survey which is performed by the u.s. census bureau, and the nyc mayor's office of operations scorecard cleanliness program, and modified through pilot testing and cognitive testing with neighborhood residents. aspects of the physical environment assessed in the scale included physical decay, vacancy and construction, municipal investment and green space. aspects of the social environment measured include social disorder, social trust, affluence and formal and informal street economy. the scale assesses features of the neighborhood environment that are determined by personal (e.g., presence of dog feces), community (e.g., presence of a community garden), and municipal (e.g., street cleanliness) factors. the scale is administered systematically block-by-block in a neighborhood. trained research staff start at the northeast corner of an intersection and walk around the blocks in a clockwise direction. staff complete the scale for each street of the block, only evaluating the right side of the street. thus for each block, three or more assessments are completed. we are in the process of assessing psychometric properties of the instrument, including inter-rater reliability and internal consistency, and determining the minimum number of blocks or street segments that need to be assessed in order to provide an accurate estimate of the neighborhood environment. these data will be presented at the conference. obj«tive: to describe and analyze the perceptions of longterm injection drug users (idus) about their initiation into injecting. toronto. purposive sampling was used to seek out an ethnoculturally diverse sample of idus of both genders and from all areas of the city, through recruitment from harm reduction services and from referral by other study participants. interviews asked about drug use history including first use and first injecting, as well as questions about health issues, service utilization and needs. thematic analysis was used to examine initiation of drug use and of injection. results: two conditions appeared necessary for initiation of injection. one was a developed conception of drugs and their (desirable) effects, as suggested by the work of becker for marijuana. thus virtually all panicipants had used drugs by other routes prior to injecting, and had developed expectations about effects they considered pleasureable or beneficial. the second condition was a group and social context in which such use arose. no participants perceived their initiation to injecting as involving peer pressure. rather they suggested that they sought out peers with a similar social situation and interest in using drugs. observing injection by others often served as a means to initiate injection. injection served symbolic purposes for some participants, enhancing their status in their group and marking a transition to a different social world. concl ion: better understanding of social and contextual factors motivating drug users who initiate injection can assist in prevention efforts. ma!onty of them had higher educational level ( %-highschool or higher).about . yo adffiltted to have history of alcohol & another . % had history of smoking. only . % people were on hrt & . % were receiving steroid. majority of them ( . ) did not have history of osteoporosis. . % have difficulty in ambulating. only . % had family history of osteoporosis. bmd measurements as me~sured by dual xray absorptiometry (dexa) were used for the analysis. bmd results were compare~ w ~ rbc folate & serum vitamin b levels. no statistical significance found between bmd & serum v taffiln b level but high levels of folate level is associated with normal bmd in bivariate and multivariate analysis. conclusion: in the studied elderly population, there was no relationship between bmd and vitamin b ; but there was a significant association between folate levels & bmd. introduction: adolescence is a critical period for identity formation. western studies have investigated the relationship of identity to adolescent well-being. special emphasis has been placed on the influence of ethnic identity on health, especially among forced migrants in different foreign countries. methodology: this study asses by the means of an open ended question identity categorization among youth in three economically disadvantaged urban communities in beirut, the capital of lebanon. these three communities have different histories of displacement and different socio-demographic makeup. however, they share a history of displacement due to war. results and conclusion: the results indicated that nationality was the major category of identification in all three communities followed by origin and religion. however, the percentages that self-identify by particular identity categories were significantly different among youth in the three communities, perhaps reflecting different context in which they have grown up. mechanical heart valve replacement amanda hu, chi-ming chow, diem dao, lee errett, and mary keith introduction: patients with mechanical heart valves must follow lifelong warfarin therapy. war· farin, however, is a difficult drug to take because it has a narrow therapeutic window with potential seri· ous side effects. successful anticoagulation therapy is dependent upon the patient's knowledge of this drug; however, little is known regarding the determinants of such knowledge. the purpose of this study was to determine the influence of socioeconomic status on patients' knowledge of warfarin therapy. methods: a telephone survey was conducted among patients to months following mechan· ical heart valve replacement. a previously validated -item questionnaire was used to measure the patient's knowledge of warfarin, its side effects, and vitamin k food sources. demographic information, socioeconomic status data, and medical education information were also collected. results: sixty-one percent of participants had scores indicative of insufficient knowledge of warfarin therapy (score :s; %). age was negatively related to warfarin knowledge scores (r= . , p = . ). in univariate analysis, patients with family incomes greater than $ , , who had greater. than a grade education and who were employed or self employed had significantly higher warfarm knowledge scores (p= . , p= . and p= . respectively). gender, ethnicity, and warfar~n therapy prior to surgery were not related to warfarin knowledge scores. furthermore, none of t~e. m-hospital tea~hing practices significantly influenced warfarin knowledge scores. however, panic ~ants who _rece v~d post discharge co~unity counseling had significantly higher knowledge scores tn comp~r son with those who did not (p= . ). multivariate regression analysis revealed that und~r~tandmg the ~oncept of ?ternational normalized ratio (inr), knowing the acronym, age and receiving ~ommum !' counseling after discharge were the strongest predictors of warfarin kn~wledge. s~ oeconom c status was not an important predictor of knowledge scores on the multivanate analysis. poster sessions v ~the majority of patients at our institution have insufficient knowledge of warfarin therapy.post-discharge counseling, not socioeconomic status, was found to be an important predictor of warfarin knowledge. since improved knowledge has been associated with improved compliance and control, our findings support the need to develop a comprehensive post-discharge education program or, at least, to ensure that patients have access to a community counselor to compliment the in-hospital educatiop program. brenda stade, tony barozzino, lorna bartholomew, and michael sgro lnttotl#ction: due to the paucity of prospective studies conducted and the inconsistency of results, the effects of prenatal cocaine exposure on functional abilities during childhood remain unclear. unlike the diagnosis of fetal alcohol spectrum disorder, a presentation of prenatal cocaine exposure and developmental and cognitive disabilities does not meet the criteria for specialized services. implications for public policy and services are substantial. objective: to describe the characteristics of children exposed to cocaine during gestation who present to an inner city specialty clinic. mnbods: prospective cohort research design. sample and setting: children ages to years old, referred to an inner city prenatal substance exposure clinic since november, . data collection: data on consecutive children seen in the clinic were collected over an month period. instrument: a thirteen ( ) page intake and diagnostic form, and a detailed physical examination were used to collect data on prenatal substance history, school history, behavioral problems, neuro-psychological profile, growth and physical health of each of the participants. data analysis: content analysis of the data obtained was conducted. results: twenty children aged to years (mean= . years) participated in the study. all participants had a significant history of cocaine exposure and none had maternal history or laboratory (urine, meconium or hair) exposure to alcohol or other substances. none met the criteria of fetal alcohol spectrum disorder. all were greater than the tenth percentile on height, weight, and head circumference, and were physically healthy. twelve of the children had iqs at the th percentile or less. for all of the children, keeping up with age appropriate peers was an ongoing challenge because of problems in attention, motivation, motor control, sensory integration and expressive language. seventy-four percent of participants had significant behavioral and/or psychological problems including aggressiveness, hyperactivity, lying, poor peer relationships, extreme anxiety, phobias, and poor self-esteem. conclusion: pilot study results demonstrated that children prenatally exposed to cocaine have significant learning, behavioural, and social problems. further research focusing on the characteristics of children prenatally exposed to cocaine has the potential for changing policy and improving services for this population. methods: trained interviewers conducted anonymous quantitative surveys with a random sample (n= ) of female detainees upon providing informed consent. the survey focused on: sociodemographic background; health status; housing and neighborhood stability and social resource availability upon release. results: participants were % african-american, % white, % mixed race and % native american. participants' median age was , the reported median income was <s , year, and % reported receiving a high school diploma or equivalent. women reported a number of health conditions rypical of underserved populations, including asthma ( %), sexually transmitted infections ( %), high blood pressure ( %), hcv ( %), diabetes ( %) and hiv ( %). nearly half ( %) did not anticipate having a place to stay for at least days upon release. factors significantly associated housing stability upon release were: high family support score (adjusted odds ratio [aor) . ; % confidence interval ( % cl) . , . ), high neighborhood stability score (aor . ; % cl . , . ), wanting a commercial sex worker (csw) support group (aor . ; % cl . , . ); and identifying as bisexual (aor . ; % cl . , . ). women desired employment ( %), housing ( %), education ( %), drug treattnent ( %), help with custody of children ( %), childcare ( %), and domestic violence suppon ( %) services. conclusions: female detainees represent one of urban centers' most marginalized pcjpwatioos. short periods of detention represent a unique opportunity for _interven?~ns bri~ co~s and public health institutions. service providers should collaborate ~ th local ~ails to .p~de a con uwnof care for female detainees upon release that includes transportation , housing, residential drug treallllcnt, employment, education, family reunification, childcare and domestic viol~nce su~rt. ~pecial attenlion is warranted to lesbian and bisexual women and csws, who may be especially margmalized &om family and service-based support networks. introduction: "health care and ethnic minority immigrants" examines how health care policy dil· ferences between canada and the united states impact the health-related hardships, access and use of preventative care, and health outcomes of urban ethnic minority immigrants in both countries. methods: the findings of this paper build on the results of my qualitative comparative study of hotel workers in vancouver, bc and seattle, wa that revealed greater health related hardships for similarly matched employees in seattle compared to vancouver. in this paper, i examine the generalizability of these findings at the cross-national level for similar ethnic minority immigrant groups. i compare the impact of health care policy differences on specific groups that have emigrated to cities in both canada and the united states. these include immigrants from china, viemam, philippines, west indies, africa, sri lanka, pakistan, and latin america. comparative statistical analysis -utilizing rel· evant data from statistics canada and the u.s. census -reveal the extent to which health policy differ· ences help explain how current health policy in the united states disadvantages urban ethnic minority immigrants. results: many ethnic minority immigrants are a part of the working poor, a group which disproportionately lacks health insurance coverage in the united states. their position in the labour market makes them most vulnerable to exclusion from health care services. the data reveals how current u.s. health policy creates barriers for recently arrived ethnic minority immigrants to access health insurance and care. it remains difficult to ascribe health outcome differences directly to policy differences because of the challenge in disentangling the complex interacting interventing variables, including income inequality, that determine health outcomes. yer suggestive evidence suggests that health policy in the united states is harming the health of urban ethnic minority immigrants. the current health policy regime in the united states harms the health access, care, and outcomes of urban ethnic minority immigrants. comparing the fortunes of similar immigrants in cana· dian and u.s. cities reveals these patterns of disadvantage and some of their consequences. these barriers are an understudied factor in the sociological literature on "segmented assimilation" and social exclu· sion. the paper ends with policy recommendatio ns to improve access to health care among ethnic minor· ity immigrants in both countries, with the goal of reducing health related hardships, and improving health outcomes. mass index deyu pan, richard baker, and keith norris badtgrou~ over the past decades, there has been dramatic increase in prevalence of obesity in the us population. however, the relationship between obesity and the prevalence of cardiovascular dis· ease (cv~) risk factors in different race/ethnic groups over time is not well known. . ik~rgn: _we use cross-sectional , nationally representative surveys: national health and nutri· t nal examination survey (nhanes iii - (n= ) and nhanes nhanes - , including white, black, and hispa~ic races who were no~preg~ant, aged to years. res lt : the preval~nce of high cholesterol level (~ mg/dl), untreated high blood pressure ( : l / mm hg) an~ diabetes were calculated according to bmi group (lean, < ; overweight, - ; and obese, : ) for different race/ethnicity groups. over the approximately years period (from l ~ ~o [ ] [ ] [ ] [ ] , reducrion in cvd risk factors in non-hispanic white has been observed. for mmonty race/~hnicity groups, black and hispanic, there had been increases in prevalence in high blood fa pressure and diabetes. the lean group experienced larger increase in prevalence of those cvd risk ctors. . fo~~ the prevalence in cvd risk factors over time had reduced in most of the bmi ca egoes r t e w ~~e population. however, for black and hispanic, prevalence of of cvd risk factors ave generauy uncreased, especially in overweight and obese groups. methods: strategies identified to achieve these goals include: developing meaningful neighbourhood and district boundaries for comparing health information, providing free access to neighbourhood health profiles (including relevant data at the smallest level for which valid rates could be calculated); mapping relationships of inequality at a variety of nested levels; providing a range of formats (maps, tables) to meet the needs of users; providing technical support; seeking user input to advance and improve the site; and conducting workshops to foster access and use of data for decision-making , advocacy and collaboration. an evaluation strategy is being developed to assess the efforts and impact of these strategies. a preliminary assessment of the results of the first six months of activity will be completed in october . results: significant differences in health are shown at all the geographic levels indicating success in developing the boundaries. results tabulated for the first six months use of the site include: site visits; media use; reference/acknow ledgement of the site in other documents; number of contacts through presentations and workshops; feedback from users identifying strengths and limitations; and, response from health decision makers. members of the partnership are identifying additional tools and services to further support actions that reduce health inequalities. the assessment will be used to develop more specific goals, targets and monitoring mechanisms. conclusions: our experience with paper-based health profiles indicates that they have been used extensively for program planning and advocacy. the greater availability of information in a publiclyavailable web-based format is expected to translate into even greater usefulness and wider application. the web site has had considerable usage to date, extensive media coverage. site users and workshop participants have provided positive feedback and suggestions for next steps. the six month review will be available in october . in india, more than and a half people are hiv-positive and half a million have aids. india currently has the largest number of positive people in the world, oumumbering south africa and accounting for nearly one tenth of the global hiv/aids prevalence. the world bank predicts that by , there will be million hiv/aids cases in india. the central challenge facing hiv prevention efforts in south asia today is learning how to respond to the societal determinants of vulnerability to hiv. hiv/aids is an issue largely engulfed by social stigma. stigma and discrimination are often considered the foremost barriers to effective poster sess ns v prevention and care initiatives. stigma can make a person afraid of disclosing their status~ ~yone el se, and may make them feel depressed or alone. stigma can .also le~d to poor adherence to medicanon, ~ likelihood to access health and social services, and less desire to hve. hiv+ men and women may beafraidtotd! their co-workers that they have hiv for fear of their reactions or for fear of losing their jobs. in a study conducted of people living with hiv/aids in delhi, india ov~r. -~, many respo~ts shared their experiences of discrimination in their families, in their communmes, an~ m health ~e settmgs. these findings will be shared in the workshop, and will be compa~ed to m~ ex~nences workmg as an ~ co~l~ at the center for aids prevention studies in san francisco, cahforma and congreso de lannos unidos m philadelphia, pennsylvania. the workshop will include an overview of hiv/aids in urban contexts in tht united states (los angeles, san francisco, new york, philadelphia) and south asia (delhi, hyderabad, chennai). differences in methods for outreach, prevention and treatment efforts between devdoped world and developing world contexts will be discussed. a large portion of the workshop will be centered on discussion. participants will engage in an exercise to categorize their ideas of stigma. the workshop will also include a powerpoint presentation on the quantitative data gathered from the survey. the number of homeless and runaway youth is increasing in toronto, which is currently home to out of youth in the gt a who live alone, and it is the preferred locale for the street-involved and homeless youth. the city's youth population is expected to grow by nearly % by , the school dropout rate is rising, and there are is a paucity of empirical data on what works with these at-risk youth. over a two-year period, ( ) ( ) ( ) , youthlink-inner city, conducted an evaluation of the impact of a harm reduction program aimed at reducing street youth's risk of contracting/infecting others with the hep c virus, which has both short-term and long-term deleterious effects. demographic data from street-youth, along with resources/services used, employment methods, type and frequency of drug use, health status, police contacts, and their views of program impact were analyzed using a standardized sur· vey. additionally, focus groups with youth, agency staff and community key informants were conducted, as well as in-depth interviews with three youth, over a sixth-month period. this paper details study results, which both inform both practice and future study about what works, why it works, and how best to work with these vulnerable youth. sho~ed .that the wasteland in this area was contaminated by as cd zn pb cu simultaneously. the con-ta~matton of as ~d was quit significant. the contamination problems and environmental issues in this region are very. serious. the awareness on environmental and health issues was investigated by spot survey and analysis. overall awareness among the residents in the region is very poor. the measures must be taken to assu~e t~e .sustainable economy development by local and central gorvernments. keywords nandan guangx ; mmmg area; environmental awareness. concern like, epileptic fits, vision problems, earache, cough of more than weeks and urinary problems. ninety-five subjects did not take bath regularly and were exposed to sex. the health problems identified are only of a particular point of time and it may be difficult to interpret the depth of "iceberg" of the street children's world also draw the health-illness continuum. periodic interaction and follow-up is very difficult as they generally disappear from the research setting due to their frequent mobility for survival measures. as per the prediction of the iceberg theory, only some problems may have been identified, larger problems in respect to their health may not have been identified. in spite of various limitations, this attempt had proven that, it is possible to enter the street children world, explore the iceberg of illnesses, and establish data of health-illness continuum through an effective nursing agency. it is recommended to deworm these children, provide nutritional education, establish "condom corners" and "street children help line" in the city and urban slum areas and undertake action research on their health. malnutrition is a serious problem in developing countries like bangladesh. malnutrition causes a great deal of child suffering. malnutrition is one of the major causes of morbidity and mortality among the child. the aim of present study was to investigate the nutritional status and its relation to socioeconomic conditions of urban disadvantaged child of under five years age. nutritional status was determined by anthropoemetric measurement(heig ht, weight, mid-arm circumference etc.). determination of total protein and serum albumin were done for biochemical examination. haematological examination was done by blood haemoglobin profile estimation by cynmethhaemoglob in method and determination of haematocrit value or packed cell volume (pcv). stool examination for ova of hook worm, round worm, trichuris species and other species were also done. relevant information on socioeconomic characteristics was recorded by interviewing the house hold head using pretested questionnaire. our study demonstrated that nutritional status of the children are positively correlated with family income, parents level of formal education and negatively related to the family size. the effect of family income on the nutritional status, haematological and biochemical indices of urban disadvantaged child under five will be discussed in detail which will help us to determine proper way of utilization of health care facilities exists in developing countries. introduction: with the increase in morbidity and reduction in mortality and with the introduction of highly active antiretroviral therapy (haart), there is increasing focus on the determinants of healthrelated quality of life (hrqol) in hiv-infection. the focus on the present study is to examine the relationship between social support, depression, and hiv disease severity, and the extent to which these variables impact on hrqol in adult men with hiv-infection. methods: as part of a larger ongoing natural history study focusing on the neurobehavioural complications of hiv and aids, we administered questionnaires to assess depression (beck depression inventory), social support, and hrqol (mos-hiv) to adult men with hiv-infection. a structured interview was used to collect health information and data on hiv disease severity. physical and mental health summary scores (phs and mhs) were derived through principal components analysis. participants were grouped according to level of social support: "well supported" (n= ), "moderately supported" (n= ), "little or ineffective support" (n= ). analysis of variance was conducted to assess the effects of three levels of perceived social support, depression status (present vs absent), and hiv disease severity (aids vs non-aids) on mental and physical health dimensions of hrqol. potential interaction effects were also evaluated. results: social support was found to have a significant effect on both mhs and phs. presence of depression was found to have a significant effect on mhs but not phs. hiv disease severity (presence of aids diagnosis) was found to have a significant effect on phs but not mhs. manov a analyses revealed no significant interactions effects. conclusions and implications: level of social support, presence of depression and hiv disease severity were shown to have independent effects on hrqol. feeling "well supported" appears to have significant benefits for mental and physical health. biological indicators of hiv disease appear to have a selective impact on physical health while presence of depression is related to significant reductions in mental health. the development and evaluation of behavioural interventions to improve perceived social support network and depression will likely result in significant improvements in health outcomes of adults with hiv and aids. introduction: ongoing medical advances have greatly enhanced the longevity of penons living with aids (plwa). however, for certain subgroups living with hiv/aids, including, members of minority groups, women and the economically underprivilege d, aids outcomes have not changed so favorably. one obvious factor to consider when explaining disparities in aids outcomes is the environ· ment within which an individual resides. few studies of aids outcomes have focused on how commu· nity setting influences the effectiveness of care delivery. the principle research questions were: ) what is the relationship between the locations of areas with concentrations of pl wa and the distribution of both primary and ancillary service providers? ) how has the widespread availability of haart (after ) impacted aids outcomes at the community level? ) how do aids mortality and fatality rates vary when related community characteristics, such as household income, ethnic mix, and geographic access to primary and ancillary hiv/aids services are considered? we examine this issue across residential communities in the los angeles area. methods: los angeles county's comprehensive aids service providers database (compiled and maintained by aids project los angeles) was geo-referenced and distances between weighted mean population centers and the nearest hiv/aids service providers were calculated to provide a measure of access which was then merged with aids diagnosis and mortality data along with relevant socioeconomic and population indicators and for analysis using bivariate and multivariate statistics at the zip code level. results: there is a growing disparity in hiv/aids outcomes between low-income minority areas and affluent non-minority areas in the post-haart era (p = . ). ancillary aids services such as case management and counseling and testing are located near the places where low income hiv/aids service consumers are likely to live (p =. ). in spite of having more access to ancillary services low income areas continue to be associated with smaller decreases post-haart aids mortality rates (p= . ). conclusions: given the increasing disparities in aids outcomes between lower and upper income communities in the post -haart era, more specific research into the capacities of aids services providers and the efficiency of their interventions is required. although it is clear that ancillary services are operating in the areas of greatest need, their effectiveness remains limited. understanding the reasons for t~is, be they lack of adequate resources for inner city service providers, failure to reach target popula· tmns or other causes, requires additional research. in ? , y.out~ who were able to speak either french or english and had been absent from their parent's/ c~regivers ~es. dence for at least three consecutive nights took part in the survey which consisted of inter· viewer-adm ms tered question~aires. p.arti~i~an~s were recruited from drop in centres in cities across <?-nada.y~uth self-report as either using in ect on or non-injection drugs. statistical analyses were car· r ed out using sas version . the 'home' is a contested site for many women living in urban areas. women living in poverty and using illicit drugs are largely excluded from participation in dominant 'home-base' gender roles of wife and mother because of economic disadvantage. they thus 'make home' in ways that are specific to their everyday experiences. while research has established links between housing, health and drug use, this literature does not tend to consider the meanings that home may have within the lives of women who lack access to adequate tenured living spaces. this presentation reports the findings of my master's thesis work. using grounded theory methodology within a poststructuralist feminist conceptual framework, i conducted in-depth, open-ended interviews with women living in the toronto area. the women were recruited from within the community through posters at different social service agencies (e.g., drop-in centres, community health centres). they were asked to describe their housing experiences and what home meant to them over the course of their lives. through the data analysis process, a substantive theory of 'making home' for women living in poverty and using illicit drugs emerged. the central concept of making home is a continual process of learning about and interacting with the environment. the process of making home entails different subprocesses: finding home (knowing what is available and accessible, and accessing home), adaptation, and leaving home. the different meanings of home that women developed from their experiences and knowledge emerged as critical components for the process of making home. the women i interviewed were very mobile and experienced constant change with regards to home. home was not considered only in relation to physical living space. home could be made within a relationship or with regards to a possession. while dominant meanings of home relation to tenured living spaces are generally positive, my research indicated that home could also be a negative context. the presentation will describe my research process and findings as well as the theoretical and policy implications of my results. in the western democracies, social citizenship bundles the right to social provision (defined as a share of the social good, not necessarily proportionate to the market value of a citizen's contribution) with participation in the paid labour force. for this reason, social citizenship rights, which usually involve some kind of redistributive measures, are a key mechanism by which states ensure economic equality, or at least, economic equality of opportunity, but are also a mechanism of social exclusion. social rights are inscribed around a single kind of relationship, that which exists between a male family breadwinner and the paid labor market; those who make economic contributions that fall outside this relationship -such as unpaid care-work, or, work that occurs in shadow or underground economiesare to a greater or lesser degree barred from accessing citizen-based social provisions. furthermore, social provision that occurs outside of the breadwinner/market-eco nomy dyad is very often meanstested and is accompanied by regulatory state apparatuses (this includes a range of social services, from welfare payments, to child-care subsidies, to disability pensions). social citizenship is thus stratified; the legal relationship that is at the heart of social citizenship acts as a form of social closure against claims for a share of the social good made by those who are 'lesser' citizens than others. of particular interest in this paper is how citizenship inequalities translate into inequalities in the social provisions that emerge from economic participation: the right to safety on the job, protection from employer harassment, protection from the vagaries of the market as well the right to adequate, comprehensive, and appropriate health services. drawing on mixed methods, longitudinal data from adult sex workers (n= ) located in two research sites with different social welfare regimes -one in canada and one in the u.s. -we examine the consequences of working in a "shadow" or "underground" economy on various facets of health and access to health services, taking into consideration the mediating role that citizenship constructs and social welfare regimes play in accessing other key social and economic determinants of health. methods: the study population included methadone patients (re)admitted at the mhs in the period from / / to / / , born in the netherlands, morocco, surinam, dutch antilles or turkye, and officially registered in the population register of amsterdam. the population register was used to ascer· rain the vital status. causes of death were provided by the central bureau of statistics. mortality was categorised as hiv related, directly drug related (overdose) and other.mortality. results: the methadone patients had the following characteristics: years of age at entry; % male; % ethnic minority; % ever injected. in total, personyear (py) of observation time and deaths ( % hiv related, % overdose; % other) were observed. hence, the crude mortality rate was / py ( % ci - / py). the percentage of (ever) injectors was higher among the native dutch than among the ethnic minorities, % and % respectively. higher rates were observed among native dutch drug users compared to those belonging to an ethnic minority (age adjusted hazard ratio (hr) . ( % ci . - . ). the age adjusted hr of (ever) injecting drug users versus non injecting users was . ( % cl . - . ). after additional adjustment for route of administration a non significant difference between the dutch and ethnic minorities remained (hr . , % cl . - . , p-value . . conclusion: the mortality rate among the heroin users in amsterdam is strongly affected by the high prevalence of non-injecting drug use. moreover, this study confirms that differences in mortality between the native dutch and the ethnic minorities is related to differences in route of administration. the ongoing reduction of injecting drug use (due tot selctieve mortality, and switching route ofadministration and popularity of crack cocaine) may lead to a further reduction of mortality rates among heroin users in amsterdam. interventions preventing the initiation of injecting should be encouraged. . introduction: food insecurity is an inequality that is central in the lives of many low-income cana· d ans. people lack food security when regular access to nutritious food is limited or variable due to high prices'. low income, lack of transportation or inadequate food distribution, or they become disadvan· taged m other w~ys through the acquisition of food. a group comprising academics, health profession· als, and commumty workers who have experience in food insecurity, developed a pilot study in ottawa that sought to und~rstand the lived experience of food insecurity. the study also used the united states department of agriculture (usda) community food security module. methods: a series of group meetings determined the best research approaches; questionnaires and consent forms were developed by a working group. twenty-three self-identified food insecure respon· dents were interviewed. the data were analysed using frequency distributions· the food security module was coded according to the usda coding guide, and open-ended responses w~re coded using a grounded approach. renlts: preliminary results from our pilot study have given the research team cause for considerable concern. out of households without children, experienced food insecurity with hunger; ~ere at the severe l~vel. out of households with children, experienced food insecurity with hunger. ~•rst person reflecnons commonly featured feelings of depression low self-esteem and despair. participants' account tha d . an cu ty gettmg to the store, severely limited putting knowledge and skills mto practice. l'oster sessions v conclusion: based on these early findings, our research team is looking to challenge what appear to be assumptions about poverty and food insecurity and for best ways to use this information. some policy approaches and interventions that encourage people to eat better and exercise more, may be missing the mark for low-income individuals, and may serve to maintain food insecurity. future research will build on this pilot. with methods augmentation, and a comprehensive knowledge dissemination plan, we hope co contribute to research and policy frameworks at all levels. ps- (a) mental health and the corrections system: population-based analyses in urban, semi-urban, and rural settings julian somers, robert watts, and michelle patterson introduction: according to recent epidemiological research, rates of mental disorders vary considerably across countries and across regions within countries. nevertheless, rates of mental disorders (including substance use disorders) are consistently higher in populations involved in the corrections sys- em. courts have long recognized the heavy burden of mental illness within their purview, and have developed innovative programs to better manage the needs of such individuals. the majority of these innovations (e.g., specialized courts) exist in urban settings. however, few studies have examined the degree of variability in rates of different mental disorders between courts in urban and other settings (e.g., semi-urban, rural). variability between courts in different settings, if present, holds implications for needs-based resource planning. the present study was conducted as part of a long-term inter-ministerial collaboration in british columbia (bc). analyses were conducted on linked administrative data regarding population health and correctional services. a database was constructed including all individuals sentenced in bc in a single year (n= , ). corrections records were matched to records of health services utilization (hospital and outpatient services) for mental disorders and substance use disorders in the years preceding sentencing. services for mental health and substance-related problems were aggregated into three groups: severe mental illness (smi); less-severe mental illness (lsmi); alcohol/other drug (ad). courts were grouped, based on their annual volumes, inro three categories: "urban"; "semi-urban" and "rural." rates of service use for mental disorders were compared between groups for -year and -years preceding sentencing. results: there were significant differences in the rates of mental disorders in courts of different size (urban, semi-urban, rural) . however, differences between the rates of disorders within each of these groups exceeded the discrepancies between groups. comparatively high and low rates of disorders were observed in courts of each size. moreover, the courts with the highest rates of certain disorders (e.g., ad) did not have the highest rates of other types of mental disorders (e.g., smi). conclusions: rates of mental disorders differed significantly among the annual populations sentenced across courts in bc. urban courts (which process comparatively large numbers of people) have implemented services to address the needs of the mentally ill. the present analyses strongly suggest that program development should be closely linked to the demonstration of need. the results caution that a uniform approach to court programs for the mentally ill is likely to be inefficient, over-supplying services in some settings and underestimating need in others. results: public settings used for injection are characterized by highly unhygienic conditions, the presence of unsafely disposed syringes, limited availability of sterile syringes and a lack of sterile water for injecting. a number of unsafe injection practices observed were common among public injectors. the presence of police officers nearby and the potential of assault by street predators fostered rushed injecting among those consuming drugs in public spaces. the ecological features of these environments encourage unhygienic and unsafe injecting practices, heighten risk for overdose and the transmission of blood borne viruses. introduction: approximately % of women experience depression in the first weeks or months after giving birth. although it has been argued that postpartum depression (ppd) is a culture-bound p~ nomenon, experienced only in western, industrialized countries, recent international research studies have confirmed that the prevalence of ppd is similar around the world. however, little is known about variables that may influence the experience of ppd in women from diverse cultures and immigrant women. research is needed to identify the role culture may play in the presentation of ppd (i.e., types of symptoms most commonly reported), how women from various racial, ethnic and cultural backgrounds perceive and attribute their symptoms of ppd, and finally, how culture can be appropriately addressed in ppd treatment programs. method: to examine the role of culture in ppd, semi-structured interviews and self-report question· naires were administered to clients of the women's health centre of st. joseph's health centre, tor· onto. participants were identified as either first generation canadians (relative newcomen) (n= ) or second generation canadian (parents were immigrants to canada) (n= ). data were collected qd these two groups of women based on: severity of depression, symptom presentation, perceived role of social supports and culturally-specific traditions, and barriers and responses to treatment. the interview data were analyzed using qualitative methods (thematic content analysis), and the following themes were identified: ) stress about passing on their culture to their children, ) lack of social support and feelings of isolation, ) perceived importance or lack of importance of cultural based tra· ditions, ) conflicts with family members. about cultural traditions and beliefs, ) mental health stigma within ethnic communities and beyond, ) race-and sex-based discrimination, and ) language barriers. conclrllion: identifying the role culture plays in the presentation of ppd, and how women from diverse backgrounds perceive and attribute their symptoms of ppd, is critical in order to establishcultur· ally appropriate guidelines for treatment options. furthermore, information gathered from this study can be used to develop policies and resources for delivering culturally competent care for newcomer wo~ who are dealing with ppd as well as the issues around acculturation (i.e., language barriers, racism). llus is of particular importance for urban health centers which provide postpartum care to diverse groups of women, and particularly recent immigrants or newcomers. ps-~ (al. contaminated 'therapeutic landscape': perceptions of the aamjiwnaang fint nation keyln smith and isaac luginaah . in~: this. paper pres;ents the findings of an ongoing study among the aamjiwnaang f!rst nanon. aam wnaang is located m the heart of samia's 'chemical valley', surrounded by cherrucal ~(ants such as esso, imperial oil, shell, suncor energy, and canada's largest hazardous waste disposal sate. safety kleen. this fint nation community is located within the st. clair river •area of concem'. as destgna~ by health canada for the population of samia and the surrounding region. although this comm_umty, by way of. its proximity to the numerous chemical plants is already exposed to high levels pollu~on, recent che?ucal dumping in ~mjiwnaang, as well as a failed proposal for another ethanol plant m the community, only helped to mtensify community concerns about potential health impacts of exposure. research on the cultural beliefs and traditions of first nation communities has established that th~ ~isting rel~tionship between first nations people and 'mother earth' is not only physical, but also_ spmtual. in this study we explore how the complex relationship between the aamjiwnaang first naaon and 'mother earth' be ha · · · i .. may c ngmg a contammated 'therapeutic' landscape. the study a so ~lores h?w aam wnaang residents are coping with these changes and with the probable conramina· boa of their community. ra!jts: aamjiwnaang residents acknowledge that they are living in a contaminated environment and are being impacted by emissions from the surrounding 'chemical valley' especially for future generations, and have expressed concerns that members of the community and mother earth are 'sick' as a result of this exposure. while moving from that 'place' has been discussed, residents have strong personal and generational connections to the land and insist however, that aamjiwnaang is their 'home' and will remain that way despite growing community concerns about the impact from industry. the contribution of this study lies in the direct involvement of community leadership in designing and conducting this research and distributing the results to further local policy development regarding community concerns on the reserve. background: truck driver are at very high risk for drug abuse because the factor contributing to drug abuse among driver are multiple. it is important to gain an understanding of the key factors that contributing to drug abuse among truck drivers. methods: seventy-truck driver aged - years were conveniently selected from the population. all the participants were male. an interview schedule was developed in the light of literature data and data were collected by personal interview with informed consent in selected urban area of eastern part of nepal. results: a considerable percentage of truck driver have less knowledge about drug abuse, its effect on body and their complication. majority of the participants ( %) explained that lack of education, financial crisis were leading factors of drug abuse. the average numbers of respondents were believed that lack of meaning in life, marital disharmony. friendship with drug abuser, stress, tiredness, modernization of life pattern and freedom from the home pressure were the influencing risk factors to drug abuse. conchuion: this study reveals those truck drivers are at risk in urban area for developing drugs abuse, mostly influenced by social and environmental factors. hence, these groups should undergo certain educational programme to prevent not only drug abuse, but also prevent transmission of infectious disease among these groups. introduction: food insecurity is an inequality that is central in the lives of many low-income canadians. our group of university researchers, health professionals, and community developers conducted a study in ottawa with community workers who work with people identified as food insecure. the purpose of the study was to understand the nature of their work, and their perspectives, perceptions and experiences of the causes and consequences of food insecurity. (a parallel study was conducted with food insecure participants). methods: sampling was through local knowledge of organizations involved in the provision of food to community members. written permission for the researchers to contact workers in confidence was obtained from each organization. thirteen in-depth interviews were conducted. the interviews consisted of a number of open-ended questions. the data were collated, and analysed using a grounded approach. results: workers interviewed represented organizations that offered diverse programming and methods of food distribution intended to address the needs of the community. the provision of food was seen as a necessary response to address hunger that arose for the majority from poverty caused by low income, or levels of government income support and safety nets that were insufficient to support food requirements. workers reported that food requirements varied according to different. ethnic backgrounds, ages of recipients and family configurations, and with food preferences, and d'.etary (health) requirements. workers' observations of the effects of insufficient food on adults and children such as depression, low energy and non-participation or social disengagement matched those of food insecure respondents. food insecurity was cited as "another srressor among the mountain of problems." overall, workers presented a picture of a silent, stigmatized, poor population including children, and a lack of advocacy to address the issues. be tha th · ·ty the results suggest that workers and organizations, like the commuruty mem rs t ey msecun • · · · · f ilab'l' f food · t d ·n thei·r ab 'l 'ty to address food insecurity. l m tanons m terms o ava ty o , serve, are restnc e . . funding, and donations appeared to set the para? eters of pr~g:am r.espon~ to commuruty food msecurity. workers were concerned with program des g": and a~m mstranon that m general addr~d hunger on an emergency short-term basis, although food msecunty was long-ter_m for ~any. sustainable solutions that include knowledge translation strategies, and health and social pohcy responses were suggested and will be explored in future research that hopes to build on this pilot. background: socioeconomic deprivation as well as low levels of soc!al s.uppoi:r have .been associated with poor outcomes following cardiac surgery. pre-operative depression m ~anents with coron~ry artery disease awaiting cabg ranges from - % and is an independent predictor of post-operanve mortality. since st. michael's hospital has a large inner city population, this study was designed to determine the both the prevalence of depressive symptomatology (ds) in patients awaiting cabg as well as its relationship with socioeconomic status (ses) and social support. methods: consecutive patients referred for isolated cabg were invited to complete the centre for epidemiological studies depression scale (ces-d) as well as a social support scale and a life stressors inventory. a ces-d score of : represents mild ds and a score of : represents moderate to severe ds. participants also recorded information on functional status, perceived progression of heart failure, demographic and ses variables. all participants with ces-d scores : were considered to have ds. results: of the patients ( %) who returned the survey, ( . %) of participants had a ces-d score : with ( . %) of those having scores suggestive of severe depression. females and those with ongoing medical concerns tended to have more ds (p= . and p= . respectively). age was not related to ds. perceived worsening of symptoms and increased ccs angina class were significantly related to the presence of ds (p= . and p= . respectively) but not the number of diseased heart vessels. satisfaction with personal relationships including having someone to confide in (p= . ), feeling lonely (p= . ) and not having a partner (p= . ) were significantly related to ds. being very upset by a recent breakup in the immediate family was also significantly related to ds (p= . ). having greater than a grade education was the only ses variable related to ds (p= . ). multivariate logistic regression suggested that not being partnered and having low education were the most significant predictors of ds. conclnsion: pre-operative depression is present in at least one quarter of patients referred for cabg. since ds is related to poor outcomes following cabg, single patients with few social supports and low education should be considered at high risk for ds. these findings support the need for the development of supportive interventions in patients at risk in order to decrease post-operative morbidity. this study examines the relationship between childhood sexual abuse, sexual assault during adolescence, and hiv-risk-related behaviours in a sample of homeless youths. over the past decade, there has been increasing research devoted to the impact of childhood sexual abuse. some studies have suggested that the experience of childhood sexual abuse is associated with substance use and abuse, at· risk sexual behaviour and subsequent higher rates of hiv infection (ompad et al., ; cinq-mars et al., ; brown et al., ) . other studies have found that childhood abuse, especially sexual abuse, is c_o~n among stree~ youth (noell et al. ). this study compares sexually abused males and females livtng on the street ~th non-sexually abused street youth, with regards to unsafe sexual behaviours and e~ures to potmnal t:dv sources (e.g., tattooing, body piercing and injection drug use). the hypothe-sis oft~ ~nt study is that the prevalence of hn-risk-related behaviours will be higher among street youth vtctuns of sexual abuse than those who have not been sexually abused. the sample includes youths aged to who met specific criteria's for itinerancy ( male and female, with a mean ~of . y· and a standard deviation of . ). they were recruited through five organisations working ~th~ you~ and were~ of an ongoing cohort study. all youth completed a to minute ques· ~onnaue on their sexual behaviours, use of drugs and alcohol and other hiv risk behaviours. oral spec· unens for hiv testing were. also collected. a total of ( . %) youth reported at least one incident of ~i •~use/assault ( ~ girls ( . % of all the girls) and boys ( . % of all the boys]). preliminary descnpnve analyses pomt to sexually abused/assaulted youth showing the highest prevalence of sexual poster sessions v at-risk behaviours. for example, . % of sexual abuse/assault victims have engaged in prostitution in their lives compared with . % in the non-sexually abused/assaulted group. in addition, . % of sexual abuse/assault victims reported having injected drugs, compared with . % in the non-sexually abused/assaulted group. more statistical analyses will bring other significant factors to light, especially when we analyze separately those victim of childhood sexual abuse as compare to those victim of sexual assault after childhood. elucidating the risk factors for getting involved in hiv-risk-related behaviours is important for the development of comprehensive and appropriate prevention and treatment intervention strategies. introduction: new immigrants and refugees to canada frequently emigrate from regions of the world where intestinal parasitic infections with worms are endemic. of note, some of these parasites area capable of surviving for years to decades within a given host and can have life threatening consequences many years after initial infection. thus, early diagnosis and treatment of intestinal parasitic worms is considered important in high risk immigrant populations, however there remains a lack of consensus regarding the best method of accomplishing this. diagnosing worm infections through stool examinations is costly and has limited sensitivity, while presumptive treatment of all immigrants, although advocated by some, is expensive and results in healthy individuals being unnecessarily treated. herein, we examine the utility of a hematologic marker (i.e. peripheral blood eosinophilia) as a screening instrument to identify parasitic worm infections in new immigrants to toronto. we identified adults, years of age or older, who were screened for intestinal parasitic infections by stool examination as part of a recently developed screening protocol at a downtown toronto community health centre. we examined the prevalence of infections with worms and subsequently evaluated the impact of several demographic factors on the presence of worm infections. we also determined the sensitivity and specificity of peripheral blood eosinophilia (defined as greater than eosinophils per ml) as a marker for intestinal parasitic worm infections. results: overall, % of the immigrants tested had evidence of at least one worm infection on a single stool examination, while % of such individuals bad infections with multiple worms concurrently. age did not appear to be associated with the presence of worms, however % of males had evidence of worm infections compared with % of females (p= . ). immigrants from asia, sub-saharan africa, and central america had the highest burden of overall infection. the sensitivity and specificity of peripheral blood eosinophilia for worm infections was % and % respectively. conclusions: one in five recent immigrants presenting to a community health centre in downtown toronto had evidence of at least one intestinal parasitic worm infection. the highest burden of illness was in men and in those emigrating from less developed regions of the world. peripheral blood eosinophilia is a poor screening test for worm infections however its presence is highly suggestive of the existence of worms in new immigrants. more than a decade ago, the journal of american college health recommended that a national study be conducted to measure the health status of african american college students, 'both health disparities and [their] positive healthful behaviors' (fennell, ) . it was later decided that when exploring the level of health risk behaviors for african american students, gender is an important variable and should be included in the research (fennell, ) . at historically black college and universities (hbcus) college health researchers must tackle gender disparities through highly-effective health promotion and disease prevention programs. the purpose of this review is to examine the literature that addresses the overarching health behaviors (i.e. risky sexual behavior, poor diet, smoking, physical inactivity, etc.) of african american men who attend hbcus. despite the various social, cultural, and academic benefits of african american students who attend hbcus, the number of research studies that adequately address their health and health behaviors is limited. studies indicate that african american men who attend hbcus are actively engaged in poor health behaviors. compared to females at hbcus, african american men are more likely to behave in ways that could result in injuries and the use tobacco, alcohol, and ~ther dru~. the city of toronto has recently proposed to conduct a street count of the homeless. like proposals that have come before, this most recent proposal is controversial among many homeless advocates and service providers because it is perceived as intrusive, likely to undercount the target population, and unnecessary for addressing the problem. advocates of the count view it as necessary to gauge the scope of the problem and advise city leaders about how to most effectively direct resources ro.the various homeless services. this paper first reviews the history of efforts to count homeless populat ns m toronto, describing the motivations and arguments of people on both sides of the issue. second, the paper reviews the methodological complexities of counting homeless populations, describing approaches that use shelter-counts, administrative data and street observations. those interested in counts for toronto and elsewhere can benefit from this review of approaches that have been proposed and carried out in other municipalities. third, the paper proposes a new community-base d strategy that joins the skills of methodologists, local experts, and service providers to ensure a fair and accurate count. the method of systematic social observation avoids some of the problems of early counts by utilizing a repeated identification approach to minimize undercount bias. the method also has the advantage of involving and compensating homeless individuals for assisting with the street count estimates. the estimation approach can be implemented on a rolling basis throughout the year. drug transitions) is a multi-level study aimed at examining the associations between features of the urban environment and mental health, drug use, and risky sexual behaviors. research participants are being recruited in new york city (nyc) neighborhoods. an essential first step in the implementation of this study was to delineate boundaries for each target neighborhood that could then be used to establish sampling frames and as key units of analytic interest. although many neighborhood studies rely on pre-established definitions (e.g. those used for the census or administrative purposes), such definitions do not always reflect contemporary settlement patterns. we felt that street level observations were a neces· sary component of the definition process. methods: the procedures used to delineate neighborhoods were: ( ) development of census block maps of targeted areas; ( ) review of land use maps and census tract data to ensure, prior to going into the field, tha.t particular blocks are residential and likely to have sufficient population for recruitment purposes; and ( ) field vislts and observation in each of the targeted areas. field observations focused on: housing characteristics, including housing type and condition; characteristics of commercial areas, such as likely customer base (e.g. local or no~, socio-economic status and ethnicity of customers); pedestrian volume (including con· gregauons of people m parks and outside stores or residences); obstructions to pedestrian traffic (e.g. ma or thoroughfares, multi-block industry or institutions); and maintenance and use of open spaces. results: in making the final decisions regarding neighborhood boundaries and the inclusion or exclusion of particular. blocks, we considered a broad range of factors including evidence of homogeneity an~ heterogeneity (socmeconomic, ethnic, housing type, environmental) across blocks within and blocks ad acent to a nei.ghborhood, and across the sample neighborhoods; the potential for efficient recruit· ment of appropriate particip.ants (i.e. sufficient local pedestrian traffic); and boundaries used in reporting census data (s? that population data can be used in our analysis). . altho~gh utilization of field observations for neighborhood definitions is relatively time consuming (ap~~ox mately hours for a block area, with more diverse neighborhoods taking even longer), we annc p~t~ that it will substantially improve the quality and consistency of our data gath· ~rmg ~nd analyse~. spec f c e?'amples from neighborhoods defined through this process will be given dur· m~ this presentatmn. we will also discuss the merits and limitations of characterizing neighborhoods usmg street level observations. has been no consideration for how social networks are associated with sse. the objective of this study was to identify personal and social network characteristics associated with being a recipient of sse. in this cross-sectional study, idus who injected in the past months were recruited from syringe exchange programs in montreal, canada, between april and january . information on each participant and on the persons with whom contact had occurred in the past month were elicited using a structured, interviewer-administe red questionnaire. participants provided detailed demographic and drug use information on up to idu members with whom drugs or injecting materials were shared. using logistic regression, personal and network characteristics were examined in relation to receipt of sterile syringes. res.its: of idus, % reported receiving sterile syringes in the past month from another idu. the sample mean age was years (range - ), % male, % caucasian, and % cocaine injectors. in multivariate analyses adjusted for age and gender, recipients of sterile syringes were more likely than non-recipients to share drugs after preparation ( r= . ( . - . )), to require help or to have helped inject another idu (or= . ( . - . )), to have asked someone to get sterile syringes from a syringe exchange program (or= . [ . - . )), to lend syringes (or= . [ . - . ) ) and to use drug preparation water that was previously used by another iou ( r= . ( . - . ) ) during the past months. recipients also had a higher rate of change (p= . ) of idus in their drug injecting network during the past month. with respect to social networks, % ( / ) of idu network members were providers of sterile syringes and were more likely than non-providers to inject everyday (or= . ( . - . )). when stratified by their role as a sexual partner or as someone who provides support (e.g. friend, family member), further risk behaviours were observed in relation to sharing injecting materials with the participant. conclusion: recipients of sterile syringes and their idu network members had several high-risk behaviours for infection with bloodborne diseases. sse may afford an opportunity for the dissemination of other salutary behaviours such as information sharing on safe injecting practices between recipients and distributors. furthermore, drug injecting networks may be an avenue to reach idus who may not otherwise be exposed to preventive measures. there are numerous sources of stigma and labelling of mental and physical illness. first, the sociocultural dimension to stigma and labelling clearly influences patients, families, health care professionals and society's perception and treatment of illness. this creates multiple challenges related to illness identification and recovery, particularly in culturally diverse societies. second, the media is a major source of stigma and stereotyping with regard to a variety of mental and physical illnesses. despite increased public knowledge of many illnesses, studies have shown that stigma has intensified over the years in certain cases. a third element of stigma and labels appears with the use of diagnosis as a solution to human problems with the result that difficult to treat patients are repudiated and social issues are unaddressed. this presentation will serve to outline the development of stigma, various expressions of stigma, and consequences of stigma. it will provide some practical recommendations for the reduction of stigma related to mental and physical illness. purpose: to assess the knowledge, attitude, and practice about immunization for parent of - years old hispanic and african american children in los angeles county (lac). methods: we conducted two cluster surveys in lac. the sample was selected with probability proportionate to estimated size at the first stage and simple random sample of children at the second stage. data were collected through interview. we absuacted vaccine coverage data from immunization record card (irc) at home or from clinic records. the participation was % in hispanics and % in african americans populations. irc was not available at home for % of african american and % of hispanic children. results: all parents perceived their children got all necessary vaccine~. fa~orable attitudes to.w~rd immunization were reported by % of african american and % of h s?amc parents. '.he m~ ority of the parents ( % african american and % hispanic) agreed that vaccines prevent senous d se~ses among children. regarding vaccine safety, significantly more hispanic parents ( %) than african american parents ( %) mentioned that vaccines are safe. introduction: cervical cancer has been shown to be preventable by papanicolau tests in heterosexual women; however, the utility of papanicolau test in lesbians is controversial. cervical cancer is caused by the human papillomavirus (hpv) which is transmitted by sexual _intercourse; howev_er, its' transmission by homosexual intercourse is also controversial. the goal of this study was to review the evidence for papanicolau tests in lesbians. methods: a pub med, ovid ( ovid ( to , and cochrane library search was performed using the mesh headings "homosexuality , female," "vaginal smears," and "papillomavirus, human." in pub med, the clinical queries feature was used with "diagnosis" and "broad, sensitive" filters. a google advanced search of the internet was conducted with the terms "lesbian," "cervical cancer," and "pap rest." the url was limited to ".ca," ".edu," or ".gov." results: the search yielded original articles and reviews, but no cochrane reviews. none of the publications were canadian. website hits were found and selected websites were reviewed. studies showed that lesbians have fewer papanicolau tests than heterosexual women; however, many reported risk factors for cervical cancer, including multiple past or current sexual partners (male and female), early age of first coitus, history of sexually transmitted diseases, and cigarette smoking. hpv has been detected in - % of lesbians and - % of lesbians who have never had sex with men. case studies of abnormal papanicolau tests in lesbians who have never had sex with men have also been reponed. sexual transmission of hpv among lesbians can be explained by several factors: ) - % of lesbians have had sex with men and - % of lesbians continue to have sex with men. ) hpv may be transmitted by sexual behaviours among women, like digital-vaginal sex, digital-anal sex, oral sex, and the use of insertive sex toys. ) hpv transmission requires only skin-to-skin contact. genital hpv has been identified on human fingers. some professional organizations, like the society of obstetricians and gynecologists of canada and the american cancer society, recognize the need for papanicolau tests in lesbians. other organizations, like the canadian cancer society, do not have official policy statements. the current ontario cervical screening program does not specifically address lesbians. conclusion: although the data was limited, most studies recommended that lesbians should receive papanicolau tests. the frequency of these tests was controversial. policy makers and professional organizations should address the needs of this special population and make specific recommendations . monique chaaya, ahia sibai, hiam chemaitelly, and zana el roueiheb . literature concerning the mental and physical effect of work at an old age is contradictory. in addinon, urban environments are physically and socially harsh with reduced potential for income generation and employment and increased potential for depression. the present paper is an attempt to study how do work, or lack of work, link to the experience of depression among older adults in underprivileged lebanese urban communities. the data comes from a cross-sectional survey, where elderly residing in underprivileged communities in beirut, including a palestinian refugee camp, were successfully inter-v ewed through face-to-face interviews. logistic regression was performed to assess the effect of work on depression ad_justing for many other covariates. data showed that . % of people aged years and more were still workmg. there was a highly protective effect of work on depression in elderly males (or= . , % cl= . - . ). the current study is the first of its kind in the arab region and more work shou_ld be _don_e in this area. it is important for the lebanese government to consider elderly rights for social mclus n m terms of employment opportunities. amam nuru-jeter, nancy adler, and burton singer . l~u~on:_ the socioeconomic gradient is perhaps the most persistent and significant finding in social epidem ological research. the insistent nature of the ses effect is evidenced by its significance after acc?untmg for ~umerous confounds. the significance and magnitude of the effect, however, varies by ::•al group. evidence_ o_f the relative effect of race and ses is inconclusive. further, less attention has f ~ ptid to the specific interactions of race and ses than to examinations of which is a better predictor d ~ th. ~sues are further complicated by the explanatory complexity of the various measures of ses anl . owht ey relate to the health of various social groups. understanding the specific nature of these re a ons ips s necessary for guiding he ith d · i · · h a an soc a po mes and programs aimed at improving t e poster sessions v health of our most disadvantaged groups, and therefore population health, overall. this study examines the synergistic effects of ses with both race and gender in predicting group differences in mortality. methods: analyses use data from the national longitudinal mortality survey (n= , ) for the years , , and - ; and were linked to the national death index for deaths occurring through . results were confirmed using data from the national mortality followback survey for people who died in (n= , ) and the national health interview survey (denominator). we used correlation analysis and the standardized mortality ratio to examine ses (education and income), race, and gender as predictors of group differences in changes in mortality. results: for the total population, analyses support the income gradient showing significant declines in mortality ratios from low to high income along the income strata. education shows a significant drop in mortality with completion of high school and completion of college, exhibiting a threshold rather than a gradient effect. compared to whites, blacks receive diminishing health returns for each subsequent level of income and education; with whites closely mirroring the total population in ses thresholds. similarly, compared to men, women do not experience the same health gains at comparable ses levels. for education, black men and women only show significant mortality declines upon completion of high school. the ses gradient operates differently among race and gender subgroups. threshold effects suggest resource gains in life opportunities at particular milestones along the ses gradient. further, ses matters less for blacks and women compared to whites and men suggesting differing implications for health and social policy aimed at reducing disparities. objective: we assessed the impact of diabetes in a large puerto rican community of chicago by measuring the prevalence of diagnosed diabetes and calculating the diabetes mortality rate. methods: we analyzed data from a comprehensive health survey conducted in randomly selected households in community areas. questions on diagnosed diabetes and selected risk factors were asked. in addition, mortality data were analyzed in order to calculate the age-adjusted diabetes mortality rate. when possible, rates were compared to those found in other studies. results: the diabetes prevalence located in this community ( . %: % cl= . %- . %) is one of the highest ever reported for puerto ricans. for instance, it is more than three times higher than the prevalence for the us ( . %) and twice the prevalence for puerto ricans in new york ( . %) and puerto rico ( . %- . %). diagnosed diabetes was found to be significantly associated with obesity (p= . ). the prevalence was particularly high among older people, females, those horn in the us, and those with a family history. the diabetes mortality rate ( . per , population) was more than twice the rate for all of chicago ( . ) and the us ( . ). conclusions: understanding why the diabetes and mortality rates for puerto ricans in this commu· nity are so much higher than those of other communities is imperative. collaboration between researchers, service providers and community members can help address the issues of diabetes education, early screening and diagnosis and effective treatment needed in this community. introduction: sars is a respiratory illness that is spread from person to person through dose contact. this infectious disease outbreak was unusual due to the high rate of infection among health care workers. the aim of the study is to explore the demographic and attitudinal determinants of psychological distress due to sars among health care workers of a toronto hospital. methods: a total of adult participants completed questionnaires co assess psychological distress (impact of event scale -jes) and attitudes to sars. of these, participants completed the questionnaire during the sars i outbreak, and participants completed the questionnaire during the sars ii outbreak. participants also provided information on demographic variables, including occupation and exposure to sars. principal components analysis was used to derive eight attitudinal scales: fear: system, protection, prevention, job stress, stigma, instrumental coping, and psychological copm~. l ear regression analyses were applied to evaluate the associations of the demographic and amtudmal variables, as well as time, with psychological distress. . . regression analyses showed that time and higher scores on fear, ob stress, stigma'. and instrumental coping were associated with a higher total ies score: (r =. ). contrary to expectations, none of the demographic variables was associated with total ies score. conclusion: the presence of psychological distress in health care workers is indicative of intrusive or avoidant responses to thoughts, feelings, and memories associated with the sars outbreak. this study shows that ( ) fear for one's health and the he~lth of.others, ( ) ex~erien~in~ job stress, ( )_tbe per· ception of stigma, ( ) usage of instrumental copmg skills, ~n~ ( ) t m_e s grufi~an~ly c~nmb~te to increased psychological distress in health care workers. potential mterventmns during mfecttous diseaie outbreaks in health care settings should be targeted to minimize the impact of these factors. purpose: the purpose of this study was to expand knowledge regarding feeding practices, know!· edge and nutritional beliefs of mothers currently residing in the dominican republic (dr). the rising incidence of obesity in children is a major national health concern and obesity in first and second-generation immigrant children also continues to rise. we know that parents (particularly mothers) shape children's early diet patterns and that immigrant mothers experience additional challenges related to acculturation and assimilation into a new culture, however there is a paucity of literature concerning the effect of immigrant adaptation to american culture on the nutrition of children. in addition, new immigrant knowledge about the causes of obesity and the resulting health implications for childhood obesity has not been assessed and reported. this qualitative study used focus group methodology to discuss views and practices related to the introduction of food for infants and feeding practices for young children, along with a discussion on knowledge and beliefs related to the causes and health implications of child· hood obesity. ten dominican mothers' of young children (birth to years old) who reside in a small town in the western frontier area of the dr were participants in the focus group. results from this srudy will be compared to results from an identical study that will be conducted in fall with new immi· grant mothers from the dr to the boston area. we will compare feeding practices, beliefs and knowledge about nutrition for young children between these two groups. methods: using participatory principles, a focus group design was used to interview a group of mothers in the dr. the investigator along with a bilingual translator conducted the focus group. the session was tape recorded and is currently in the process of being transcribed and translated. transcribed data will be systematically analyzed themes will be identified. a qualitative data analysis software will be used to organize and code the data according to the specific aims of the study. supporting quotations will be selected to substrate each theme. lmpli~tions for urban health practice: an ultimate goal of this study is to lay a foundation for understanding the process of acculturation on feeding practices of mothers when they immigrate to the us. understanding beliefs, knowledge and feeding practices that mothers use with young children will help m ~he ~evelopment of culturally and linguistically appropriate educational strategies and materials for use m primary prevention of pediatric obesity. in canada more than seventy-five percent of immigrants choose to stay in three major urban centers of toronto, montreal and vancouver. approximately fifty percent of the immigrants eventually set· tie m ~~e greater tor<_>nto area. there is mounting evidence that the increasing immigrant population has a_ sigmfic~nt health disadvantage over canadian-born residents. this health disadvantage manifests particularly m the ma "ority of "mm "gr t h h d be · · h . . . . an s w o a en m canada for longer than ten years. this group as ~n associ~te~ with higher risk of chronic disease such as cardiovascular diseases. this disparity twccb n ma onty of the immigrant population and the canadian-born population is of great importance to ur an health providers d" · i i · b as isproporttonate y arge immigrant population has settled in the ma or ur an centers. generally the health stat f · · · · · · h h been . us most mm grants s dynamic. recent mm grants w o av_e ant •;ffca~ada _for less ~han ~en years are known to have a health advantage known as 'healthy imm • ~ants r::r · ~:s eff~ ~ defined by the observed superior health of both male and female recent immi- immigrant participation in canadian society particularly the labour market. a new explanation of the loss of 'healthy immigrant effect' is given with the help of additional factors. lt appears that the effects of social exclusion from the labour market leading to social inequalities first experienced by recent immigrant has been responsible for the loss of healthy immigrant effect. this loss results in the subsequent health disadvantage observed in the older immigrant population. a study on patients perspectives regarding tuberculosis treatment by s.j.chander, community health cell, bangalore, india. introduction: the national tuberculosis control programme was in place over three decades; still tuberculosis control remains a challenge unmet. every day about people die of tuberculosis in india. tuberculosis affects the poor more and the poor seek help from more than one place due to various reasons. this adversely affects the treatment outcome and the patient's pocket. many tuberculosis patients become non-adherence to treatment due to many reasons. the goal of the study was to understand the patient's perspective regarding tuberculois treatment provided by the bangalore city corporation. (bmc) under the rntcp (revised national tuberculosis control programme) using dots (directly observed treatment, short course) approach. bmc were identified. the information was collected using an in-depth interview technique. they were both male and female aged between - years suffering from pulmonary and extra pulmonary tuberculosis. all patients were from the poor socio economic background. results: most patients who first sought help from private practitioners were not diagnosed and treated correctly. they sought help form them as they were easily accessible and available but they. most patients sought help later than four weeks as they lacked awareness. a few of patients sought help from traditional healers and magicians, as it did not help they turned to allopathic practitioners. the patients interviewed were inadequately informed about various aspect of the disease due to fear of stigma. the patient's family members were generally supportive during the treatment period there was no report of negative attitude of neighbours who were aware of tuberculosis patients instead sympathetic attitude was reported. there exists many myth and misconception associated with marriage and sexual relationship while one suffers from tuberculosis. patients who visited referral hospitals reported that money was demanded for providing services. most patients had to borrow money for treatment. patients want health centres to be clean and be opened on time. they don't like the staff shouting at them to cover their mouth while coughing. conclusion: community education would lead to seek help early and to take preventive measures. adequate patient education would remove all myth and conception and help the patients adhere to treatment. since tb thrives among the poor, poverty eradiation measures need to be given more emphasis. mere treatment approach would not help control tuberculosis. lntrod#ction: the main causative factor in cervical cancer is the presence of oncogenic human papillomavitus (hpv). several factors have been identified in the acquisition of hpv infection and cervical cancer and include early coitarche, large number of lifetime sexual partners, tobacco smoking, poor diet, and concomitant sexually transmitted diseases. it is known that street youth are at much higher risk for these factors and are therefore at higher risk of acquiring hpv infection and cervical cancer. thus, we endeavoured to determine the prevalence of oncogenic hpv infection, and pap test abnormalities, in street youth. ~tbods: this quantitative study uses data collected from a non governmental, not for profit dropin centre for street youth in canada. over one hundred females between the ages of sixteen and twentyfour were enrolled in the study. of these females, all underwent pap testing about those with a previous history of an abnormal pap test, or an abnormal-appearing cervix on clinical examination, underwent hpv-deoxyribonucleic (dna) testing with the digene hybrid capture ii. results: data analysis is underway. the following results will be presented: ) number of positive hpv-dna results, ) pap test results in this group, ) recommended follow-up. . the results of this study will provide information about the prevalence of oncogemc hpv-dna infection and pap test abnormalities in a population of street youth. the practice implic~ tions related to our research include the potential for improved gynecologic care of street youth. in addition, our recommendations on the usefulness of hpv testing in this population will be addressed. methods: a health promotion and disease prevention tool was developed over a period of several years to meet the health needs of recent immigrants and refugees seen at access alliance multicultural community health centre (aamchc), an inner city community health centre in downtown toronto. this instrument was derived from the anecdotal experience of health care providers, a review of medical literature, and con· sultations with experts in migration health. herein we present the individual components of this instrument, aimed at promoting health and preventing disease in new immigrants and refugees to toronto. results: the health promotion and disease prevention tool for immigrants focuses on three primary health related areas: ) globally important infectious diseases including tuberculosis (tb), hiv/aids, syphilis, viral hepatitis, intestinal parasites, and vaccine preventable diseases (vpd), ) cancers caused by infectious diseases or those endemic to developing regions of the world, and ) mental illnesses includiog those developing among survivors of torture. the health needs of new immigrants and refugees are complex, heterogeneous, and ohen reflect conditions found in the immigrant's country of origin. ideally, the management of all new immigrants should be adapted to their experiences prior to migration, however the scale and complexity of this strategy prohibits its general use by healthcare providers in industrialized countries. an immigrant specific disease prevention instrument could help quickly identify and potentially prevent the spread of dangerous infectious diseases, detect cancers at earlier stages of development, and inform health care providers and decision makers about the most effective and efficient strategies to prevent serious illness in new immigrants and refugees. lntrodmction: as poverty continues to grip pakistan, the number of urban street children grows and has now reached alarming proportions, demanding far greater action than presently offered. urbanization, natural catastrophe, drought, disease, war and internal conflict, economic breakdown causing unemployment, and homelessness have forced families and children in search of a "better life," often putting children at risk of abuse and exploitation. objectives: to reduce drug use on the streets in particular injectable drug use and to prevent the transmission of stds/hiv/aids among vulnerable youth. methodology: baseline study and situation assessment of health problems particularly hiv and stds among street children of quetta, pakistan. the program launched a peer education program, including: awareness o_f self and body protection focusing on child sexual abuse, stds/hiv/aids , life skills, gender and sexual rights awareness, preventive health measures, and care at work. it also opened care and counseling center for these working and street children ar.d handed these centers over to local communities. relationships among aids-related knowledge and bt:liefs and sexual behavior of young adults were determined. rea.sons for unsafe sex included: misconception about disease etiology, conflicting cultural values, risk demal, partner pressur~, trust and partner significance, accusation of promiscuity, lack of community endorsement of protecnve measures, and barriers to condom access. in addition socio-economic pressure, physiological issues, poor community participation and anitudes and low ~ducation level limited the effectiveness of existing aids prevention education. according to 'the baseline study the male children are ex~ to ~owledge of safe sex through peers, hakims, and blue films. working children found sexual mfor~anon through older children and their teachers (ustad). recommendation s: it was found that working children are highly vulnerable to stds/hiv/aids, as they lack protective meas":res in sexual abuse and are unaware of safe sexual practices. conclusion: non-fatal overdose was a common occurrence for idu in vancouver, and was associated with several factors considered including crystal methamphetamine use. these findings indicate a need for structural interventions that seek to modify the social and contextual risks for overdose, increased access to treatment programs, and trials of novel interventions such as take-home naloxone programs. background: injection drug users (idus) are at elevated risk for involvement in the criminal justice system due to possession of illicit drugs and participation in drug sales or markets. the criminalization of drug use may produce significant social, economic and health consequences for urban poor drug users. injection-related risks have also been associated with criminal justice involvement or risk of such involvement. previous research has identified racial differences in drug-related arrests and incarceration in the general population. we assess whether criminal justice system involvement differs by race/ethnicity among a community sample of idus. we analyzed data collected from idus (n = , ) who were recruited in san francisco, and interviewed and tested for hiv. criminal justice system involvement was measured by arrest, incarceration, drug felony, and loss/denial of social services associated with the possession of a drug felony. multivariate analyses compared measures of criminal justice involvement and race/ethnicity after adjusting for socio-demographic and drug-use behaviors including drug preference, years of injection drug use, injection frequency, age, housing status, and gender. the six-month prevalence of arrest was highest for whites ( %), compared to african americans ( %) and latinos ( % ), in addition to the mean number of weeks spent in jail in the past months ( . vs. . and . weeks). these differences did not remain statistically significant in multivariate analyses. latinos reported the highest prevalence of a lifetime drug felony conviction ( %) and mean years of lifetime incarceration in prison ( . years), compared to african americans ( %, . years) and whites ( %, . years). being african american was independently associated with having a felony conviction and years of incarceration in prison as compared to whites. the history of involvement in the criminal justice system is widespread in this sample. when looking at racial/ethnic differences over a lifetime including total years of incarceration and drug felony conviction, the involvement of african americans in the criminal justice system is higher as compared to whites. more rigorous examination of these data and others on how criminal justice involvement varies by race, as well as the implications for the health and well-being of idus, is warranted. homelessness is a major social concern that has great im~act on th~se living.in urban commu?ities. metro manila, the capital of the philippines is a highly urbanized ar~ w. t~ the h gh~st concentration of urban poor population-an estimated , families or , , md v duals. this exploratory study v is the first definitive study done in manila that explores the needs and concerns of street dwdlent\omc. less. it aims to establish the demographic profile, lifestyle patterns and needs of the streetdwdlersindit six districts city of manila to establish a database for planning health and other related interventions. based on protocol-guid ed field interviews of street dwellers, the data is useful as a template for ref!!. ence in analyzing urban homelessness in asian developing country contexts. results of the study show that generally, the state of homelessness reflects a feeling of discontent, disenfranchisem ent and pow!!· lessness that contribute to their difficulty in getting out of the streets. the perceived problems andlar dangers in living on the streets are generally associated with their exposure to extreme weather condirioll! and their status of being vagrants making them prone to harassment by the police. the health needs of the street dweller respondents established in this study indicate that the existing health related servias for the homeless poor is ineffective. the street dweller respondents have little or no access to social and health services, if any. some respondents claimed that although they were able to get service from heallh centers or government hospitals, the medicines required for treatment are not usually free and are beyond their means. this group of homeless people needs well-planned interventions to hdp them improve their current situations and support their daily living. the expressed social needs of the sucet dweller respondents were significantly concentrated on the economic aspect, which is, having a perma· nent source of income to afford food, shelter, clothing and education. these reflect the street dweller' s need for personal upliftment and safety. in short, most of their expressed need is a combination of socioeconomic resources that would provide long-term options that are better than the choice of living on the streets. the suggested interventions based on the findings will be discussed. . methods: idu~ aged i and older who injected drugs within the prior month were recruited in usmg rds which relies on referral networks to generate unbiased prevalence estimates. a diverse and mon· vated g~o~p of idu "seeds." were given three uniquely coded coupons and encouraged to refer up to three other ehgibl~ idu~, for which they received $ usd per recruit. all subjects provided informed consent, an anonymous ~t erv ew and a venous blood sample for serologic testing of hiv, hcv and syphilis anti~!· results. a total of idus were recruited in tijuana and in juarez, of whom the maion!)' were .male < .l. % and . %) and median age was . melhotls: using the data from a multi-site survey on health and well being of a random sample of older chinese in seven canadian cities, this paper examined the effects of size of the chinese community and the health status of the aging chinese. the sample (n= , ) consisted of aging chinese aged years and older. physical and mental status of the participants was measured by a chinese version medical outcome study short form sf- . one-way analysis of variance and post-hoc scheffe test were used to test the differences in health status between the participants residing in cities representing three different sizes of the chinese community. regression analysis was also used to examine the contribution of size of the chinese community to physical and mental health status. rmdts: in general, aging chinese who resided in cities with a smaller chinese population were healthier than those who resided in cities with a larger chinese population. the size of the chinese community was significant in predicting both physical and mental health status of the participants. the findings also indicated the potential underlying effects of the variations in country of origin, access barriers, and socio-economic status of the aging chinese in communities with different chinese population size. the study concluded that size of an ethnic community affected the health status of the aging population from the same ethnic community. the intra-group diversity within the aging chinese identified in this study helped to demonstrate the different socio-cultural and structural challenges facing the aging population in different urban settings. urban health and demographic surveillance system, which is implemented by the african population & health research center (aphrc) in two slum settlements of nairobi city. this study focuses on common child illnesses including diarrhea, fever, cough, common cold and malaria, as well as on curative health care service utilization. measures of ses were created using information collected at the household level. other variables of interest included are maternal demographic and cultural factors, and child characteristics. statistical methods appropriate for clustered data were used to identify correlates of child morbidity. preliminary ratdts: morbidity was reported for , ( . %) out of , children accounting for a total of , illness episodes. cough, diarrhoea, runny nose/common cold, abdominal pains, malaria and fever made up the top six forms of morbidity. the only factors that had a significant associ· ation with morbidity were the child's age, ethnicity and type of toilet facility. however, all measures of socioeconomic status (mother's education, socioeconomic status, and mother's work status) had a significant effect on seeking outside care. age of child, severity of illness, type of illness and survival of father and mother were also significantly associated with seeking health care outside home. the results of this study have highlighted the need to address environmental conditions, basic amenities, and livelihood circumstances to improve child health in poor communities. the fact that socioeconomic indicators did not have a significant effect on prevalence of morbidity but were significant for health seeking behavior, indicate that while economic resources may have limited effect in preventing child illnesses when children are living in poor environmental conditions, being enlightened and having greater economic resources would mitigate the impact of the poor environmental conditions and reduce child mortality through better treatment of sick children. inequality in human life chances is about the most visible character of the third world urban space. f.conomic variability and social efficiency have often been fingered to justify such inequalities. within this separation households exist that share similar characteristics and are found to inhabit a given spatial unit of the 'city. the residential geography of cities in the third world is thus characterized by native areas whose core is made up of deteriorated slum property, poor living conditions and a decayed environment; features which personify deprivation in its unimaginable ma~t~de. there are .eviden~es that these conditions are manifested through disturbingly high levels of morbidity and mortality. ban · h h d-and a host of other factors (corrupt n, msens t ve leaders p, poor ur ty on t e one an , . · f · · · th t ) that suggest cracks in the levels and adherence to the prmc p es o socta usnce. ese governance, e c . . . . . ps £factors combine to reinforce the impacts of depnvat n and perpetuate these unpacts. by den· grou o . · "id . . bothh tifying health problems that are caused or driven by either matena _or soc a e~nvanon or , t e paper concludes that deprivation need not be accepted as a way. of hfe a~d a deliberate effon must be made to stem the tide of the on going levels of abject poverty m the third world. to the extent that income related poverty is about the most important of all ramifications of po~erty, efforts n_iu_st include fiscal empowerment of the poor in deprived areas like the inner c~ty. this will ~p~ove ~he willingness of such people to use facilities of care because they are able to effectively demand t, smce m real sense there is no such thing as free medical services. ). there were men with hiv-infection included in the present study (mean age and education of . (sd= . ) and . (sd= . ), respectively). a series of multiple regressions were used to examine the unique contributions of symptom burden (depression, cognitive, pain, fatigue), neuropsychologic al impairment (psychomotor efficiency), demographics (age and education) and hiv disease (cdc- staging) on iirs total score and jirs subscores: ( ) activities of daily living (work, recreation, diet, health, finances); ( ) psychosocial functioning (e.g., self-expression, community involvement); and ( ) intimacy (sex life and relationship with partner). resnlts: total iirs score (r " . ) was associated with aids diagnosis (ii= . , p < . ) and symptoms of pain (ii= - . , p < . ), fatigue (ji = - . , p < . ) and cognitive difficulties (p = . , p < . ). for the three dimensions of the iirs, multiple regression results revealed: ( ) activities of daily living (r = . ) were associated with aids diagnosis (ii = . , p < . ) and symptoms of pain <p =- j , p < . ), fatigue (ji = - . , p < . ) and cognitive difficulties (ji = . , p < . ); ( ) psychosocial functioning (r = . ) was associated with was associated with symptoms of fatigue (ii= - . , p < . ) and cognitive difficulties <ii = . , p < . ); and ( ) intimacy (r = . ) was related to was associated with symptoms of fatigue (ij = - . , p < . ) and cognitive difficulties (ii= . , p < . ). methods: the sif evaluation methodology involves a comprehensive database located at the sif, a randomly selected p~o.spective coh~rt of sif users, and two pre-existing external control cohorts. . . ~ts: in addmon to reporting process data and descriptions of the sif users, we report on data indicating that the establishment of the sif has been independently associated with reductions in public ~':°g ~ (p <?. ), and syringe sharing (aor = . [ %ci: . _ . ); p = . ) and other unsafe m ecnon pract _ces_ (p ~ . ), and increased uptake of detox services (log-rank p = . ). as well, we report on da~ md cat ng that the sif has not prompted adverse changes in community drug use patterns. the vancouver sif has been well accepted by the target population, and while adve~ events s~c~ as overdoses have occurred, these events have been successfully managed. externally compiled data indicate that the sif has been associated with substantial declines in public disorder !'oster sessions v associated with injection drug use, syringe sharing, and increased uptake of detox services. as well, the establishment of the sif has not exacerbated community drug use patterns. ongoing evaluation activities wiu involve assessing the impact of the sif on a variety of outcomes, including infectious disease transmission, fatal overdose, and utilization of health and social services. city, brazil, - maria cristina almeida, waleska caiaffa, renato assum;iio, and fernando proietti dengue cases were described according to time, space, intensity, age, gender, onset of symptoms, residence address and census tract. spatial distribution of two groups (children and women over years old and men aged - ) were compared, under assumption that they have distinct behaviors regarding their displacement around the city. analysis included local moran index, ripley\\'s k function and recurrence of census areas over time. about , cases were identified in seven epidemic waves. concentration of cases in small areas, followed by a spread either in space or time suggested endemic patterns. regarding age-gender groups, distinct patterns suggested that residence might not be a good proxy in determining the local of infection for men aged - . dengue is shifting to endemic pattern in this city and transmission may not be sole related to home environment, suggesting that additional spatial information must be couected aiming efficient control measures. murukan kandamuthan and subodh kandamuthan lnl uduction: illness or disablement of a child may affect the economic functioning of a family as it alters the employment pattern and earnings of parents this paper tries to assess the health status and the quality of life of disabled children, and how generally, severe disablement in a child affected their fami-lies\' finances, and to quantify any such effects the problems faced by children in their home and to provide information relevant to the formation of criteria for new or increased cash support. methods: a case-control study was done in the thiruvananthapuram district, capital city of kerala by selecting a random sample of families with severely disabled children below years and a random sample of normal children matched for age and occupation of the parents. comparative and subjective data were collected. money spent on children\'s medical care, loss of earnings of the parents, and other economic burden to the family due to the disability of the child in the family. a discriminant analysis along with univariate analysis was done to assess the factors that mostly differentiate the disabled and normal children. the mean expenditure of the families with a disabled child was rs. /-per month, which is significantly higher than the corresponding expenditure of rs. /-per month of families with normal child, (t= . , p <. ). of the disabled children, % were not getting any social security payments and % had no special concessions for medical and other educational purposes. the analysis of income and expenditure pattern indicated that financial impact of disablement in a child on the family is significant. the discriminant model results revealed that medical expenditure was a significant variable that differentiated the disabled and normal child. the study found that the health status and quality of life of the disabled children were far from satisfactory. this in fact affected the economic status of the disabled children. in addition to reduced earnings, there are extra costs for disabled children for travel, domestic help, medical care, and health care expenditures (hospital care, physician services, dentistry, drugs and others) for disabled individuals. a strong case can be made for their long-term care by improving the financial support to such families possibly through the introduction of an allowance specially to compensate for the earnings lost by parents due to the disability of their children. widows in india are considered disadvantage group of population. because they are characterized by pangs of separation from spouse, and consequently they go through mental agony, social ~s?lation, and economic dislocation. in addition to these, poverty, landlessness, homelessness, malnutr non etc. endure serious deterioration of their health. according to census , there are million women are widowed and one fourth live in urban areas. there is a noticeable increase of urban widows from the previous census (almost half). the paper examines the type of disability and chronic ailment borne among elderly widows ( years and above). fifty second round of national sample survey aske~ the individuals three sets of questions regarding their health: their status of health, whether they are physically poster sessions v immobile, and whether or not they have had any specific chronic illnesses. although health infrastruc- · ble ·n urban setting in india as compared to rural counterpart, prevalence of tures are arge y ava a . . . . . h · · · h h"gher "n urban areas analysis shows omt problems m old age qmte common c romc ness is muc • . . and nearly percent elderly widows are suffering from this ail'. ent in urban areas. one-fifth of widows are suffering from high/low bp. heart disease, diabetes and urinary problems are much ~ore pre~alent in urban areas though disabilities is comparatively lower in urban areas. however, the d~fference is not statistically significant. disability with respect to vision is more pronounced and one third_ of the total respondents have problems regarding eyesight. one fifths ofdderly widows are _ha.rd of hearing. though disability increases with age, similar trend is not observed with respect to chr~mc illness. the percepnon of self-health among elderly becomes poorer as their age increases. the perceived health status need not be always corrected to objective indicators of health. it is noted that around per~en~ of those perceived their health as "excellenr" or "very good" are found to be suffering from chrome disease of omts and percent have visual disability. to conclude an elderly widow living in urban areas have similar health problems as she jives in rural areas. this can be easily explained, as they were not made aware to seek treatment from health facility. in addition, the study shows that the economic conditions are deterrent factors for their illness. it is essential that intervention should be taken up improving their economic conditions so that wellbeing of this most vulnerable group of the society can be taken care of. heart failure is a disease that affects nearly million people world wide. the united states alone accounts for one third of this population. blacks are stricken with heart failure twice as often as whites. men are more likely to develop chf than women, however since the majority of the chf population are seniors, there are actually more women than men. congestive heart failure (chf) has become a pandemic. as the baby boomer generation ages, the number of chf cases will rise dramatically. (young, j. & mills, r., ). after the age of , each proceeding decade doubles the incidence level of chf. the average person has a in chance of developing heart failure within their lifespan according to the framingham study (nih.gov). individuals aging or older compose over half of the entire documented heart failure population. in this age group, chf is the leading cause of hospitalization. many patients are continuously readmitted. it is estimated that the chf population will increase by one million within the next years. mortality was at % for a two year period and % for five years (young, j. & mills, r., ). data from: aha as technology evolves, the understanding of the nature of heart failure has become clearer. in the beginning of the th century heart failure was diagnosed as a condition that presented with edema (swelling) in the extremities caused by water retention. treatment in the beginning of the past cenrury was limited to abdominal drainage and diuretics. the discovery of the heart's insufficient pumping ability in heart failure patients lead to new surgeries and devices such as heart transplants and ventricular assist devices (bridge until transplant is available). ventricular hypertrophy often occurs before the development of heart failure. hypertrophy is the term given for cardiac remodeling. cardiac remodeling also includes chamber dilation (young, j. & mills, r., ) . chf financial burden the us healthcare financing administration has ranked chf as the highest cost illness in the diagnose-related area. direct costs related to chf in the us for were nearly $ billion. these costs included hospital admissions, physician fees, home health aids and medications. indirect costs were over $ billion in . loss of jobs or death due to chf was the criteria for this category (young, j. & mills, r., ). . introduction: the injection drug user quality of life scale (iduqol) is a relatively new scale ~es gned to capture the unique and individual circumstances that determine quality of life among injection drug users (idus). the life areas comprising the instrument were based on the research literature an~ ~ocus group discussions with idus. the purpose of the present study was to evaluate the content validity of t.h~ iduqol using judgmental methods based on subject matter experts' (smes) ratings. content vah~ ty refers to the de~ee to which elements of an assessment tool are representative of the construct of interest and appropnate for a given population. methods: data were obtained from six smes, from the field of idu research and practice, who ~ere. asked t.o evaluate various aspects of the iduqol, including the title of the instrument, administraon instruchons, clarity of the names and descriptions of each life area, response format, scoring instruc-no~s and examples, record form and whether each life area should be included in the instrument. sme ratings were made using either or point scales. sm es were also given the opportunity to comment on poster sessions v each section and to suggest whether important life areas had been overlooked, were redundant, not relevant, or in need of revision. (cvi) and the ~v.erage ~eviation index (ad) were used to evaluate smes' agreement on ratings of the content vahd ty vanables. both measures provided support for the content validity of various aspects of the iduqol, although results from the stricter ad index noted some areas of disagreement, including the description of particular life areas (e.g., being useful, drugs, sex), the inclusion of some life areas (e.g., drug treatment, education, independence and free choice), and the ease of the scoring instructions. the findings from this study provide (a) content validity evidence to support the use of the iduqol as well as (b) recommendations to suengthen both the instrument (e.g., improved descriptions for some items) and the accompanying administration and scoring manual (e.g., an easier scoring template). changes made to the instrument and its manual make the iduqol even easier for researchers, practitioners, and program evaluators to use as a way of assessing, and tracking changes over time or as a result of interventions in, quality of life in injection drug users. introduction: strict adherence to prescribed regimens is required to derive maximal benefit from highly active antireuoviral therapy (haart) in persons living with hiv/aids (phas). adherence is a key determinant of the degree and durability of viral suppression. adherence is also essential in reducing the spread of hiv and ensuring that today's treatments remain effective for as long as possible. the objective of this study is to conduct a systematic review of the research literature on the effectiveness of education and patient support strategies for improving adherence to haart. methods: a systematic search of the core databases was performed from january until may . randomized controlled trials examining the effectiveness of education and patient support interventions to improve the adherence to haart were considered for inclusion. only those studies that measured adherence at a minimum of six weeks were included. study selection, quality assessments, and data abstraction were performed independently by two reviewers. results: study heterogeneity with respect to differing populations, interventions, outcomes, and length of follow-up did not allow for meta-analysis. we included studies involving , ph as. sample sizes ranged from to . study duration ranged from a single session to a variable number of sessions delivered over one year. many of the interventions involved the provision of an educational component to improve adherence and often addressed strategies to overcome barriers to adherence and the development of problem-solving skills. they ranged from simple interventions (e.g., the provision of reminder devices) to complex interventions (e.g., cognitive-behavioural therapy delivered by licensed psychologists). eleven of the studies demonstrated a statistically significant advantage associated with the described adherence intervention. the advantage associated with adherence outcomes does not seem to translate into the more clinically relevant outcome of viral suppression. only out of studies that reported virological or immunological results found a significant effect associated with the intervention. the studies had several methodological shortcomings. conclusions: there is a need for standardization and methodological rigour in the conduct of adherence trials. some interventions may have a significant impact on improving adherence. further research is required before any specific adherence improving strategy can confidently be incorporated into standard clinical practice. focus groups were used to collect data from a purposive sample of treatmentexperienced participants. focus group data were analyzed using a grou~ded t~eory appr~ach. i:ne themes identified from the interviews were used to identify the effects of ant rerrov rals on quality of hfe. the content of the mos-hiv was appraised against the themes identified from our analysis. participants also completed the mos-hiv survey and were asked whether the survey covered all important aspects of quality of life on antiretroviral medications. results: five key informant interviews and five focus groups with participants were used to identify effects on quality of life that are not directly ~aptu~ed by_ the mos-hiv health survey. our~~ showed that our participants described quality of hfe as mvol~mg_ a set of ~rsonal trad~ffs ~stay alive. in most cases, worsened quality of life was traded-off for gams ~ longevlty from ~~canon use. these eff~'ts or tradeoffs included: ( ) downstream consequences of side effects and toxlanes; ( ) loss of lrufe. pende~t decision-making privileges, ( ) having to choose drugs over ~areer; (~)burden of medication-taking responsibilities; and ( ) living life under a pretense and havmg to hide-the net effect of the tradeoffs, or "prices" to pay led to what was described as "longevity with hn without hope and future~. conclusion: our study highlights five major themes summarizing the impact of haart on quality on life, and suggests that currently used scales for measuring quality of life do not a~atd~ cap~e these findings and the associated consequences. the conceptual framework for measuring quality of bfe in hiv should be reconsidered in order to better capture the important effects of the medications on quality of life. this may involve widening the boundaries of the definition of health-related quality oflife to include aspects such as finances, employment, and housing. we should further consider the development of a haart adverse effect specific instrument, using a broad definition of adverse effect in order to capture all types of adverse impacts of hiv treatments on quality of life. introduction: measles (rubeola) is the most contagious vaccine preventable disease of humans. while cases of measles are uncommon in canada today, the disease continues to be a leading cause of morbidity and death in the developing world. as a result of human migration, measles cases still occur in canada, primari~ among immigrants, returning travelers, and other susceptible groups. canada's national advisory council on immunizations (naci) recommends that immigrants without records of measles immunization be considered for vac:cination since these individuals may not have been appropriately vaccinated in their native country. on rhe other hand, natural immunity to measles in immigrants is likely to be high given the high incidence of disease in developing parts of rhe world. thus it remains unclear if the most efficient strategy to achieve high levels of measles immunity in immigrants should entail initial serologic screening followed by vaccination of susceptible individuals or preemptive vaccination of all persons lacking immunization records. understanding the epidemiology of measles immunity in immigrant populations could help guide such decisions. . methods: we identified adults, years of age or older, who were screened for serologtc immunity to measles as part of a recently developed screening protocol at a downtown toronto community health centre. we subsequently determined if these individuals had any immunization records from their native country or from within canada. we then examined the relationship between several demographic factors and immunity to measles. results: % of immigrants had no prior immunization records. overall, % of the immigrants rested for immunity to measles were found to be immune; % of those under the age of , % of those between and years of age, % of those between and years of age, and % of those years of age or older. gender, education status, household income, and immigration status were nor ~ssoc ated wirh immunity to measles. immunity to measles was lowest among immigrants from eastern europe ( ~%), whil~ immigrants from other regions of the globe had greater than % immunity. c~lusrons: immigrants and refugees appear to have reasonably high levels of immunity to mea· sics, possibly related to natural infection wirh the measles virus. immigrants from eastern europe appear to have slightly. lower l~vel~ of immunity to the measles virus. universal screening for immunity to meales or preemptive vac:cmauon may both be inefficient public health strategies, however further research is needed to corroborate these findings. nancy r~ss, stephane tremblay, saeeda khan, daniel crouse, mark tremblay, and jean-marie berrhelor o~ve: the speed of the rise in obesity in places like canada suggests that rather than a shift in the gcncnc_ com~sirion of the population, the root of the obesity pandemic is an environment that suprrs ~besity. this paper examines the influence of neighbourhood and metropolitan characteristics. bour~lts:. while accounting. for individual socio-demographics and behaviours, residents of neighs with a large proportmn of poorly educated individuals had higher bmis than those living in poster sessions v neighbourhoods with more highly educated individuals (p <. ). residing in a neighbourhood with a high proportion of recent immigrants was associated with lower bmi for men (p<. ), but not women. neighbourhood dwelling density, a proxy for walkability, was not associated with bm! for either sex. metropolitan sprawl was associated with higher male bmi (p=. ) but the effect was negligible for women (p=. ). bmi was significantly lower for women (p<. ) living in a city in the province of quebec, even after accounting for the influence of individual and neighbourhood covariates. conclusions: bm! was strongly patterned by individual-level social position in urban canada. the incremental influence on bmi of neighbourhood related to the neighbourhood's social conditions and not to their physical form. metropolitan sprawl was associated with higher bm! for men, a group with longer car-dependent commutes than women. the findings suggest that both individuals and their environments (both social and physical) influence the distribution of bmi in urban populations. introduction: urban environments have been linked to a range of human health issues. in singapore, prevalence of end stage renal disease (esrd) is predicted to rise ( in to in , kidney international, vol. , . the clinical and economic burden of esrd has promoted development of strategies aimed at preventing the development and progression of chronic kidney disease. these include population based screening programs such as the national kidney foundation, sin-gapore\'s (nkfs) "partnership for prevention."the program, aims to reduce incidence of esrd through comprehensive intervention and screening for early detection of urinary abnormalities, blood pressure (bp), and random blood glucose (rbg). objective of this study is to examine gender, race and age wise prevalence of elevated bp, rbg and proteinuria. methodology: this current analysis includes , subjects, age to years, who underwent screening during september and december . participants were asked to give demographic information and the history of diseases. tests were given to get clinical information such as proteinuria, blood glucose, sbp, and dbp. blood pressure abnormalities were defined according to ]nc vi criteria. proteinuria was defined as the presence of plus or greater protein (equivalent to> mg/di) on dipstick analysis. results: there were , ( . %) males. racial distribution was chinese ( . % ), malay ( . % ), indians ( . %) and others ( . % ).among participants, who were apparently "healthy" (asymptomatic and without history of dm, ht, or kd), gender and race wise % prevalence of elevated (bp> / ), rbg (> mg/di) and positive urine dipstick for protein was as follows male: ( . ; . ; . ) female:( . ; . ; . ) chinese:( . ; . ; ) malay: ( . ; . ; . ) indian:( . ; . ; . ) others: ( . ; . ; . ) total:(l . , . , . ). percentage of participants with more than one abnormality were as follows. those with bp> / mmhg, % also had rbg> mg/dl and . % had proteinuria> i. those with rbg> mgldl, % also had proteinuria> and % had bp> / mmhg. those with proteinuria> , % also had rbg> mg/dl, and % had bp> / mmhg. conclusion: we conclude that sub clinical abnormalities in urinalysis, bp and rbg readings are prevalent across all genders and racial groups in the adult population. the overlap of abnormalities, point towards the high risk for esrd as well as cardiovascular disease. this indicates the urgent need for population based programs aimed at creating awareness, and initiatives to control and retard progression of disease. introduction: various theories have been proposed that link differential psychological vulnerability to health outcomes, including developmental theories about attachment, separation, and the formation of psychopathology. research in the area of psychosomatic medicine suggests an association between attachment style and physical illness, with stress as a mediator. there are two main hypotheses explored in the present study: ( t) that individuals living with hiv who were upsychologically vulne~able" at study entry would be more likely to experience symptoms of depression, anxiety and phys ca! illness over. the course of the -month study period; and ( ) life stressors and social support would mediate the relat nship between psychological vulnerability and the psychological ~nd physical outcomes. . (rsles), state-trait anxiety inventory (stai), beck depr~ssi~n lnvento~ (bdi), and~ _ -item pbys~i symptoms inventory. we characterized participants as havmg psychological vulnerability and low resilience" as scoring above on the raas (insecure attachment) or above on the das (negative expectations about oneself). . . . . . " . . ,, . results: at baseline, % of parnc pants were classified as havmg low resilience. focusmg on anxiety, the average cumulative stai score of the low-resilience group was significandy hi~e~ than that of the high-resilience group ( . sd= . versus . sd= . ; f(l, )= . , p <. ). similar results were obtained for bdi and physical symptoms (f( , )= . , p<. and f( , )= . , p<. , respec· tively). after controlling for resilience, the effects of variance in life stres".°rs averaged over time wa~ a_sig· nificant predictor of depressive and physical symptoms, but not of anxiety. ho~e_ver, these assooan~s became non-significant when four participants with high values were removed. s id larly, after controlling for resilience, the effects of variance in social support averaged over time became insignificant. conclusion: not only did "low resilience" predict poor psychological and physical outcomes, it was also predictive of life events and social support; that is, individuals who were low in resilience were more likely to experience more life events and poorer social support than individuals who were resilient. for individuals with vulnerability to physical, psychological, and social outcomes, there is need to develop and test interventions to improve health outcomes in this group. rajat kapoor, ruby gupta, and jugal kishore introduction: young people in india represent almost one-fourth of the total population. they face significant risks related to sexual and reproductive health. many lack the information and skills neces· sary to make informed sexual and reproductive health choices. objective: to study the level of awareness about contraceptives among youth residing in urban and rural areas of delhi. method: a sample of youths was selected from barwala (rural; n= ) and balmiki basti (urban slums; n= ) the field practice areas of the department of community medicine, maulana azad medical college, in delhi. a pre-tested questionnaire was used to collect the information. when/(calen· dar time), by , fisher exact and t were appliedxwhom (authors?). statistical tests such as as appropriate. result: nearly out of ( . %) youth had heard of at least one type of contraceptive and majority ( . %) had heard about condoms. however, awareness regarding usage of contraceptives was as low as . % for terminal methods to . % for condom. condom was the best technique before and after marriage and also after childbirth. the difference in rural and urban groups was statistically signif· icant (p=. , give confidence interval too, if you provide the exact p value). youth knew that contra· ceptives were easily available ( %), mainly at dispensary ( . %) and chemist shops ( . %). only . % knew about emergency contraception. only advantage of contraceptives cited was population con· trol ( . %); however, . % believed that they could also control hiv transmission. awareness of side effects was poor among both the groups but the differences were statistically significant for pills (p= . ). media was the main source of information ( %). majority of youth was willing to discuss a~ut contraceptive with their spouse ( . %), but not with others. . % youth believed that people in their age group use contraceptives. % of youth accepted that they had used contraceptives at least once. % felt children in family is appropriate, but only . % believed in year spacing. . conclusion: awareness about contraceptives is vital for youth to protect their sexual and reproduc· tive health .. knowledge about terminal methods, emergency contraception, and side effects of various contraceptives need to be strengthened in mass media and contraceptive awareness campaigns. mdbot:ls: elderly aged + were interviewed in poor communities in beirut the capital of f:ebanon, ~e of which is a palestinia~. refugee camp. depression was assessed using the i -item geriat· nc depressi~n score (~l?s- ). specific q~estions relating to the aspects of religiosity were asked as well as questions perta rung to demographic, psychosocial and health-related variables. results: depression was prevalent in % of the interviewed elderly with the highest proportion being in the palestinian refugee camp ( %). mosque attendance significantly reduced the odds of being depressed only for the palestinian respondents. depression was further associated, in particular communities, with low satisfaction with income, functional disability, and illness during last year. condiuion: religious practice, which was only related to depression among the refugee population, is discussed as more of an indicator of social cohesion, solidarity than an aspect of religiosity. furthermore, it has been suggested that minority groups rely on religious stratagems to cope with their pain more than other groups. implications of findings are discussed with particular relevance to the populations studied. nearly thirty percent of india's population lives in urban areas. the outcome of urbanization has resulted in rapid growth of urban slums. in a mega-city chennai, the slum populations ( . percent) face greater health hazards due to overcrowding, poor sanitation, lack of access to safe drinking water and environmental pollution. amongst the slum population the health of women and children are most neglected, resulting in burden of both communicable and non-communicable diseases. the focus of the paper is to present the epidemiology profile of children (below years) in slums of chennai, their health status, hygiene and nutritional factors, the social response to health, the trends in child health and urbanization over a decade, the health accessibility factors, the role of gender in health care and assessment impact of health education to children. the available data prove that child health in slums is worse than rural areas. though the slum population is decreasing there is a need to explore the program intervention and carry out surveys for collecting data on some specific health implications of the slum children. objective: during the summer of there was a heat wave in central europe, producing an excess number of deaths in many countries including spain. the city of barcelona was one of the places in spain where temperatures often surpassed the excess heat threshold related with an increase in mortality. the objective of the study was to determine whether the excess of mortality which occurred in barcelona was dependent on age, gender or educational level, important but often neglected dimensions of heat wave-related studies. methods: barcelona, the second largest city in spain ( , , inhabitants in ) , is located on the north eastern coast. we included all deaths of residents of barcelona older than years that occurred in the city during the months of june, july and august of and also during the same months during the preceding years. all the analyses were performed for each sex separately. the daily number of deaths in the year was compared with the mean daily number of deaths for the period - for each educational level. poisson regression models were fitted to obtain the rr of death in with respect to the period - for each educational level and age group. results: the excess of mortality during that summer was more important for women than for men and among older ages. although the increase was observed in all educational groups, in some age-groups the increase was larger for people with less than primary education. for example, for women in the group aged - , the rr of dying for compared to - for women with no education was . ( %ci: . - - ) and for women with primary education or higher was . ( %ci: . - . ). when we consider the number of excess deaths, for total mortality (>= years) the excess numbers were higher for those with no education ( . for women and . for men) and those with less than primary education ( . for women and - for men) than those with more than primary edm:ation ( . for women and - . for men). conclusion: age, gender and educational level were important in the barcelona heat wave. it is necessary to implement response plans to reduce heat morbidity and mortality. policies should he addressed to all population but also focusing particularly to the oldest population of low educational level. introduction: recently there has been much public discourse on homelessness and its imp~ct on health. measures have intensified to get people off the street into permanent housing. for maximum v poster sessions success it is important to first determine the needs of those to be housed. their views on housing and support requirements have to be considered, as th~y ar~ the ones affected. as few res.earch studies mclude the perspectives of homeless people themselves, httle is known on ho~ they e~penence the mpacrs on their health and what kinds of supports they believe they need to obtain housing and stay housed. the purpose of this study was to add the perspectives of homeless people to the discourse, based in the assumption that they are the experts on their own situations and needs. housing is seen as a major deter· minant of health. the research questions were: what are the effects of homelessness on health? what kind of supports are needed for homeless people to get off the street? both questions sought the views of homeless individuals on these issues. methods: this study is qualitative, descriptive, exploratory. semi-structured interviews were conducted with homeless persons on street corners, in parks and drop-ins. subsequently a thematic analysis was carried out on the data. results: the findings show that individuals' experiences of homelessness deeply affect their health. apart from physical impacts all talked about how their emotional health and self-esteem are affected. the system itself, rather than being useful, was often perceived as disabling and dehumanizing, resulting in hopelessness and resignation to life on the street. neither welfare nor minimum wage jobs are sufficient to live and pay rent. educational upgrading and job training, rather than enforced idleness, are desired by most initially. in general, the longer persons were homeless, the more they fell into patterned cycles of shelter /street life, temporary employment /unemployment, sometimes addictions and often unsuccessful housing episodes. conclusions: participants believe that resources should be put into training and education for acquisition of job skills and confidence to avoid homelessness or minimize its duration. to afford housing low-income people and welfare recipients need subsidies. early interventions, 'housing first', more humane and efficient processes for negotiating the welfare system, respectful treatment by service providers and some extra financial support in crisis initially, were suggested as helpful for avoiding homelessness altogether or helping most homeless people to leave the street. this study is a national homelessness initiative funded analysis examining the experiences and perceptions of street youth vis-a-vis their health/wellness status. through in-depth interviews with street youth in halifax, montreal, toronto, calgary, ottawa and vancouver, this paper explores healthy and not-so healthy practices of young people living on the street. qualitative interviews with health/ social service providers complement the analysis. more specifically, the investigation uncovers how street youth understand health and wellness; how they define good and bad health; and their experiences in accessing diverse health services. findings suggest that living on the street impacts physical, emotional and spiritual well·being, leading to cycles of despair, anger and helplessness. the majority of street youth services act as "brokers" for young people who desire health care services yet refuse to approach formal heal~h care organizational structures. as such, this study also provides case examples of promising youth services across canada who are emerging as critical spaces for street youth to heal from the ravages of ~treet cultur~. as young people increasingly make up a substantial proportion of the homeless population in canada, it becomes urgent to explore the multiple ways in which we can support them to regain a sense of wellbeing and "citizenship." p - (c) health and livelihood implications of marginalization of slum dwellers in provision of water and sanitation services in nairobi city elizabeth kimani, eliya zulu, and chi-chi undie . ~ntrodfldion: un-habitat estimates that % of urban residents in kenya live in slums; yet due to their illegal status, they are not provided with basic services such as water sanitation and health care. ~nseque~tly, the services are provided by vendors who typically provide' poor services at exorbitant prices .. this paper investigates how the inequality in provision of basic services affects health and livelihood circumstances of the poor residents of nairobi slums . . methods: this study uses qualitative and quantitative data collected through the ongoing longitudmal .health and demographic study conducted by the african population and health research center m slum communities in n ·rob" w d · · · · ai . e use escnpnve analytical and qualitative techmques to assess h~w concerns relating to water supply and environmental sanitation services rank among the c~mmumty's general and health needs/concerns, and how this context affect their health and livelihood circumstances. results: water ( %) and sanitation ( %) were the most commonly reported health needs and also key among general needs (after unemployment) among slum dwellers. water and sanitation services are mainly provided by exploitative vendors who operate without any regulatory mechanism and charge exorbitantly for their poor services. for instance slum residents pay about times more for water than non-slum households. water supply is irregular and residents often go for a week without water; prices are hiked and hygiene is compromised during such shortages. most houses do not have toilets and residents have to use commercial toilets or adopt unorthodox means such as disposing of their excreta in the nearby bushes or plastic bags that they throw in the open. as a direct result of the poor environmental conditions and inaccessible health services, slum residents are not only sicker, they are also less likely to utilise health services and consequently, more likely to die than non-slum residents. for instance, the prevalence of diarrhoea among children in the slums was % compared to % in nairobi as a whole and % in rural areas, while under-five mortality rates were / , / and / respectively. the results demonstrate the need for change in governments' policies that deprive the rapidly expanding urban poor population of basic services and regulatory mechanisms that would protect them from exploitation. the poor environmental sanitation and lack of basic services compound slum residents' poverty since they pay much more for the relatively poor services than their non-slum counterparts, and also increase their vulnerability to infectious diseases and mortality. since iepas've been working in harm reduction becoming the pioneer in latin america that brought this methodology for brazil. nowadays the main goal is to expand this strategy in the region and strive to change the drug policy in brazil. in this way harm reduction: health and citizenship program work in two areas to promote the citizenship of !du and for people living with hiv/aids offering law assistance for this population and outreach work for needle exchange to reduce damages and dissemination of hiv/aids/hepatit is. the methodology used in outreach work is peer education, needle exchange, condoms and folders distribution to reduce damages and the dissemination of diseases like hiv/aids/hepatitis besides counseling to search for basic health and rights are activities in this program. law attendance for the target population at iepas headquarters every week in order to provide law assistance that includes only supply people with correct law information or file a lawsuit. presentations in harm reduction and drug policy to expand these subjects for police chiefs and governmental in the last year attended !du and nidu reached and . needles and syringes exchanged. in law assistance ( people living with aids, drug users, inject drug users, were not in profile) people attended. lawsuits filed lawsuits in current activity. broadcasting of the harm reduction strategies by the press helps to move the public opinion, gather supporters and diminish controversies regarding such actions. a majority number of police officer doesn't know the existence of this policy. it's still polemic discuss this subject in this part of population. women remain one of the most under seviced segments of the nigerian populationand a focus on their health and other needs is of special importance.the singular focus of the nigerian family welfare program is mostly on demographic targets by seeking to increase contraceptive prevalence.this has meant the neglect of many areas of of women's reproductive health. reproductive health is affected by a variety of socio-cultural and biological factors on on e hand and the quality of the service delivery system and its responsiveness on the other.a woman's based approach is one which responds to the needs of the adult woman and adolescent girls in a culturally sensitive manner.women's unequal access to resources including health care is well known in nigeria in which stark gender disparities are a reality .maternal health activities are unbalanced,focusi ng on immunisation and provision of iron and folic acid,rather than on sustained care of women or on the detection and referral of high risk cases. a cross-sectional study of a municipal government -owned hospitalfrom each of the geo-political regions in igeria was carried out (atotal of ce~ters) .. as _part ~f t~e re.search, the h~spital records were uesd as a background in addition to a -week mtens ve mvesuganon m the obstemc and gynecology departments. . . . : little is known for example of the extent of gynecological morbtdtty among women; the little known suggest that teh majority suffer from one or more reproductive tr~ct infect~ons. although abortion is widespread, it continues to be performed under ilegal and unsafe condmons. with the growing v poster sessions hiv pandemic, while high riskgroups such ascomn;iercial sex workers and their clients have been studied, little has been accomplished in the large populat ns, and particularly among women, regardmgstd an hiv education. . . conclusions: programs of various governmentalor non-governmental agen,c es to mvolve strategies to broaden the narrow focus of services, and more importan~, to put wo~en s reproducnve health services and information needs in the forefront are urgently required. there is a n~d to reonent commuication and education activities to incorprate a wider interpretation of reproducnve health, to focus on the varying information needs of women, men, and youth and to the media most suitable to convey information to these diverse groups on reproductive health. introduction: it is estimated that there are - youths living on the streets, on their own with the assistance of social services or in poverty with a parent in ottawa. this population is under-serviced in many areas including health care. many of these adolescents are uncomfortable or unable to access the health care system through conventional methods and have been treated in walk-in clinics and emergency rooms without ongoing follow up. in march , the ontario government provided the ct lamont institute with a grant to open an interdisciplinary and teaching medical/dental clinic for street youth in a drop-in center in downtown ottawa. bringing community organizations together to provide primary medical care and dental hygiene to the streetyouths of ottawa ages - , it is staffed by a family physician, family medicine residents, a nurse practitioner, public health nurses, a dental hygienist, dental hygiene students and a chiropodist who link to social services already provided at the centre including housing, life skills programs and counselling. project objectives: . to improve the health of high risk youth by providing accessible, coordinated, comprehensive health and dental care to vulnerable adolescents. . to model and teach interdisciplinary adolescent care to undergraduate medical students, family medicine residents and dental hygiene students. methods: non-randomized, mixed method design involving a process and impact evaluation. data collection-qualitative:a) semi-structured interviews b) focus groups with youth quantitative:a) electronic medical records for months b) records (budget, photos, project information). results: in progress-results from first months available in august . early results suggest that locating the clinic in a safe and familiar environment is a key factor in attracting the over youths the clinic has seen to date. other findings include the prevalence of preventative interventions including vaccinations, std testing and prenatal care. the poster presentation will present these and other impacts that the clinic has had on the health of the youth in the first year of the study. conclusions: ) the clinic has improved the health of ottawa streetyouth and will continue beyond the initial pilot project phase. ) this project demonstrates that with strong community partnerships, it is possible meet make healthcare more accessible for urban youth. right to health care campaign by s.j.chander, community health cell, bangalore, india. introduction: the people's health movement in india launched a campaign known as 'right to health care' during the silver jubilee year of the alma ata declaration of 'health for all' by ad in collahoration with the national human rights commission (nhrc). the aim of the campaign was to establish the 'right to health care' as a basic human right and to address structural deficiencies in the pubic health care system and unregulated private sector . . methods: as part of the campaign a public hearing was organized in a slum in bangalore. former chairman of the nhrc chaired the hearing panel, consisting of a senior health official and other eminent people in the city. detailed documentation of individual case studies on 'denial of access to health care' in different parts of the city was carried out using a specific format. the focus was on cases where denial of health services has led to loss of life, physical damage or severe financial losses to the patient. results: _fourte_en people, except one who had accessed a private clinic, presented their testimonies of their experiences m accessing the public health care services in government health centres. all the people, e_xcept_ one person who spontaneously shared her testimony, were identified by the organizations worki_ng with the slum dwellers. corruption and ill treatment were the main issues of concern to the people. five of the fourteen testimonies presented resulted in death due to negligence. the public health cen· n:s not only demand money for the supposedly free services but also ill-treats them with verbal abuse. five of these fourteen case studies were presented before the national human right commission. the poster sessions v nhrc has asked the government health officials to look into the cases that were presented and to rectify the anomalies in the system. as a result of the public hearing held in the slum, the nhrc identified urban health as one of key areas for focus during the national public hearing. cond#sion: a campaign is necessary to check the corrupted public health care system and a covetous private health care system. it helps people to understand the structure and functioning of public health care system and to assert their right to assess heath care. the public hearings or people's tribunals held during the campaign are an instrument in making the public health system accountable. ps- (a) violence among women who inject drugs nadia fairbairn, jo-anne stoltz, evan wood, kathy li, julio montaner, and thomas kerr background/object ives: violence is a major cause of morbidity and mortality among women living in urban settings. though it is widely recognized that violence is endemic to inner-city illicit drug markets, little is known about violence experienced by women injection drug users (!du). therefore, the present analyses were conducted to evaluate the prevalence of, and characteristics associated with, experiencing violence among a cohort of female idu in vancouver. methods: we evaluated factors associated with violence among female participants enrolled in the vancouver injection drug user study (vidus) using univariate analyses. we also examined self-reported relationships with the perpetrator of the attack and the nature of the violent attack. results: of the active iou followed between december , and may , , ( . %) had experienced violence during the last six months. variables positively associated with experiencing violence included: homelessness (or= . , % ci: . - . , p < . ), public injecting (or= . , % ci: . - . , p < . ), frequent crack use (or= . , % ci: . - . , p < . ), recent incarceration (or = . , % cl: . - . , p < . ), receiving help injecting (or = . , % cl: . - . , p < . ), shooting gallery attendance (or = . , % ci: . - . , p < . ), sex trade work (or = . , % cl: . - . , p < . ), frequent heroin injection (or= . , % cl: . - . , p < . ), and residence in the downtown eastside (odds ratio [or] = . , % ci: . - . , p < . ). variables negatively associated with experiencing violence included: being married or common-law (or = . . % ci: . - . , p < . ) and being in methadone treatment (or = . , % ci: . - . , p < . ). the most common perpetrators of the attack were acquaintances ( . %), strangers ( . %), police ( . %), or dealers ( . %). attacks were most frequently in the form of beatings ( . %), robberies ( . %), and assault with a weapon ( . %). conclusion: violence was a common experience among women !du in this cohort. being the victim of violence was associated with various factors, including homelessness and public injecting. these findings indicate the need for targeted prevention and support services, such as supportive housing programs and safer injection facilities, for women iou. introduction: although research on determinants of tobacco use among arab youth has been carried out at several ecologic levels, such research has included conceptual models and has compared the two different types of tobacco that are most commonly used among the lebanese youth, namely cigarette and argileh. this study uses the ecological model to investigate differences between the genders as related to the determinants of both cigarette and argileh use among youth. methodology: quantitative data was collected from youth in economically disadvantaged urban communities in beirut, the capital of lebanon. results: the results indicated that there are differences by gender at a variety of ecological levels of influence on smoking behavior. for cigarettes, gender differences were found in knowledge, peer, family, and community influences. for argileh, gender differences were found at the peer, family, and community l.evels. the differential prevalence of cigarette and argileh smoking between boys and girls s therefore understandable and partially explained by the variation in the interpersonal and community envi.ronment which surrounds them. interventions therefore need to be tailored to the specific needs of boys and girls. introduction: the objective of this study was to assess the relationship between parents' employment status and children' health among professional immigrant families in vancouver. our target communmes v poster sessions included immigrants from five ethnicity groups: south korean, indian, chine~e, ~ussian, and irani~ with professional degrees (i.e., mds, lawyers, engineers, ma?~ger~, and uru~ers ty professors) w h no relevant job to their professions and those who had been hvmg m the studied area at least for months. methodology: the participants were recruited by collaboration from three local community agencies and were interviewed individually during the fall of . ra#lts: totally, complete interviews were analyzed: from south-east asia, from south asia, from russia and other eastern europe. overall, . % were employed, . % were underemployed, % indicated they were unemployed. overall, . % were not satisfied with their current job. russians and other eastern europeans were most likely satisfied with their current job, while south-east asians were most satisfied from their life in canada. about % indicated that their spouses were not satisfied with their life in canada, while % believed that their children are very satisfied from their life in canada. in addition, around % said they were not satisfied from their family relationship in canada. while most of the responders ranked their own and their spouses' health status as either poor or very poor, jut % indicated that their first child's health was very poor. in most cases they ranked their children's health as excellent or very good. the results of this pilot study show that there is a need to create culturally specific child health and behavioral scales when conducting research in immigrant communities. for instance, in many asian cultures, it is customary for a parent either to praise their children profusely, or to condemn them. this cultural practice, called "saving face," can affect research results, as it might have affected the present study. necessary steps, therefore, are needed to revise the current standard health and behavioral scales for further studies by developing a new scale that is more relevant and culturally sensitive to the targeted immigrant families. metboda: database: national health survey (ministry of health www.msc.es). two thousand interviews were performed among madrid population ( . % of the whole); corresponded to older adults ( . % of the . million aged years and over). study sample constitutes . % ( out of ) of those older adults, who live in urban areas. demographic structure (by age and gender) of this population in relation to health services use (medical consultations, dentist visits, emergence services, hospitalisation) was studied using general linear model univariate procedure. a p . ), while age was associated with emergence services use ( % of the population: %, % and % of each age group) and hos~italisation ( % .oft~~ population: %, % and %, of each age ~oup) (p . ) was fou~d with respect to dennst v s ts ( % vs %), medical consultations ( % vs %), and emergence services use ( % vs %), while an association (p= . ) was found according to hospitalisation ( % vs %). age. an~ g~der interaction effect on health services use was not found (p> . ), but a trend towards bosp tal sanon (p= . ) could be considered. concl.uions: demographic structure of urban older adults is associated with two of the four health se~ices use studi~. a relation.ship ber_ween age. and hospital services use (emergence units and hospitalisanon), but not with ~ut-hosp tal sei:vices (medical and dentist consultations), was found. in addition ro age, gender also contnbutes to explam hospitalisation. . sexua experiences. we exammed the prevalence expenences relation to ethnic origin and other sociodemographic variables as wc i as y j die relation between unwanted sexual experiences, depression and agreuion. we did so for boys and prts separately. mdhods: data on unwanted sexual expcric:nces, depressive symptoms (ce.s-d), aggrc:uion (bohi-di and sociodemographic facron were collected by self-report quescionnairc:s administettd to students in the: nd grade (aged - ) of secondary schools in amsterdam, the netherlands. data on the nature ol unwanted sexual experiences were collected during penonal interviews by trained schoolnursn. ltaijtj: overall prevalences of unwanted sexual experiences for boys and girls were . % and . % respectively. unwanted sexual experiences were more often ttported by turkish ( . %), moroc· an ( . %) and surinamese/anrillian boys ( . %) than by dutch boys ( . %). moroccan and turkish girls, however, reported fewer unwanted sexual experiences (respectively . and . %) than durch girls did ( . %). depressive symptoms(or= . , cl= . - . ) covert agression ( r• . , cl• . - . ) and cmrt aggression (or= . , cl• . - . ) were more common in girls with an unwanted sexual experi· met. boys with an unwanted sexual experience reported more depressive symptoms (or= . ; cl• i . .l· . ) and oven agression (or= . , cl= . - . ) . of the reported unwanted sexual experiences rnpec· timy . % and . % were confirmed by male and female adolescents during a personal interview. cond sion: we ..:an conclude that the prevalence of unwanted sexual experiences among turkish and moroccan boys is disturbing. it is possible that unwanted sexual experiences are more reported hy boys who belong to a religion or culture where the virginity of girls is a maner of family honour and talking about sexuality is taboo. more boys than girls did not confirm their initial disdosurc of an lllwalltc:d sexual experience. the low rates of disclosure among boys suggcsu a necd to educ.:atc hcahh care providen and others who work with migrant boys in the recognition and repomng of exu.il ... iction. viramin a aupplc:tmntation i at .h'yo, till far from tafl'eted %. feedinit pracn~:n panku· lerty for new born earn demand lot of educatton ernpha a• cxdu ve hrealt fecdtnit for dnared rcnoj of months was observtd in only .s% of childrrn thoulh colckturm w. givm n rn% of mwly horn ct.ildrm. the proportion of children hclow- waz (malnounshrdl .con" a• h!jh •• . % anj "rt'i· acimy tc.. compared to data. mother's ~alth: from all is womm in ttprod~uvr •ill' poup, % were married and among marned w~ .\ % only w\"rt' u mic wmr cnntr.-:cruve mt h· odl % were married bdorc thc •ar of yean and % had thnr ftnc prcicnancy hcftitt dlt' •icr nf yean. the lt'f'vicn are not uutfactory or they arc adequate but nae unh ed opumally. of thote' l'h mothen who had deliverrd in last one year, % had nailed ntmaral eum nat on ira" oncc, .~o-... bad matt rhan four ttmn and ma ortty had heir tetanus toxotd tnin,"t or"'" nlht "'"'"· ljn r ned rn· win ronductrd . % dchvcnn and % had home deh\'t'oc'i. ~md~: the tervtcn unbud or u led are !tu than dnarame. the wr· l'kft provided are inadequate and on dechm reprcwnttng a looun t ~p of h hnto good coytti\#' ol wr· ncn. l!.ckground chanpng pnoriry cannoc be ruled out u °"" of thc coatnbutory bc f. ps-ii ia) dcpn:wioa aad anuccy ia mip'mu ia awccr._ many de wn, witco tui~bmjer. jack dekker, aart·jan lttkman, wim gonmc:n. and amoud verhoeff ~ a dutch commumry-bucd icudy thawed -moarh•·prc:yalm«i al . ' . kw anx · ay daorden and . % foi' dqrasion m anmttdam. nm .. p tficantly hlllhn than dwwhrft .. dw ~thew diffamca m pttyalcnca att probably rdarcd to tlk' largr populanoa of napaan ..\mturdam. <turkish %, moroccan %, and surinam % . lndttd. ic'wt'll ltudla hatt ~ ~ high prevalena rata among migrant poupi in rbe ncdwrlands. howc'ytt au ttlluchn iuffenod from wry low raporne rara, or med screnung talel thac lack a ~y yabdarcd ~ in order to study the prevalence of depression and anxiety, and the (barriers to) use of mental health care among the different ethnic groups the following study was recently conducted: . the study consisted of a two-step approach. the first step was mcl~ded m the ~ h ith survey of (ahs), and consisted of three screening scales for depression and aruaety (klo, g::q- and mhl- ). in this survey all respondents were asked_ permission for~ second app~ :' t consisted of a structured interview containing the cidi for aruaety and depression, and questtollllalres on health care seeking, amongst others. all respondents who gave permission for a second approachwere invited by jetter for a suuctured interview with multilingual interviewers at home at a preset date and time in the following week. . in total, dutch, turkish, moroccan and surinam respondents took part in the ahs and gave permission for a second approach. in the second step, fo~ ~ tur~h, m~roc can surinamese and dutch respondents, information from the extensive interview was available (res~nse rates between and % ). since the data collection was completed only recently (june ), prevalence estimates can be presented at the conference for the first time. we have shown that with this approach it is feasible to achieve an acceptable response rate in a study on mental health among migrants. therefore we expect that this study will provide reli· able estimates of depression and anxiety in the turkish, moroccan and surinam migrants in amstw! ~· for the first time. in addition, insight into mechanisms underlying the differences between and within ethnic groups and into barriers to mental health care will provide pretexts for the improvement of pre· vention and mental health care for migrant groups. this study aimed to determine spatial patterns of mortality and morbidity of five major health problems in an urban environment: homicides, pregnancy among adolescents ((< years old), asthma hospitalization among young children(< years old) and two mosquito-borne diseasesdengue and visceral leishmaniasis, during - . all events were obtained through the city health database and, subsequently, geoproccsscd using the address of residence and the geographical and administrative division of the municipality, composed by unit of planning (up), which in tum were formed, each one, by census tract units. two research questions were investigated: are there spatial patterns to the events dis· tribution, and moreover, are these patterns overlapping across space? we use thematic maps, index of comparative mortality/morbidity by up and the overlapped rank of the th worse up rates for each event. a spatial pattern of high rates of homicides, proportion of young mothers and hospitalization of asthma were overlapping in areas social and economically disadvantaged. for mosquito-borne diseases, high rates with great dispersion were found in unprivileged areas in contrast with very low rares among privileged ones. these results pointed toward a coexistence of heavier burden of diseases for those living in areas of the city where misery, poverty, lack of political public health may be modulating social health problems. a possible environmental intervention in one mosquito•bome disease might be playing a role in the occurrence of other. although with limitations, this study may provide useful information for a joint urban planning under the public perspective, articulated for use in health impact assessment. jalil safaei bdrod#aion: the association of socioeconomic status (ses), usually measured by income, and health status is an established result in bcalth studies. the poor and low income individuals have lower health sta· tus then_ those with higher incomes. in general. such finding has been usually obtained from sample surveys on speafic populations. a problem with many sample survey$ is that their results are not comparable aaoss ~ndaries as they may use different sampling methods, ask different questions, categorize the answers differently, or define groups differently. moreover, the sample data need to be standardized using the demographic: katurea of a ~ population. this study, however, uses the national population health survey (nphs) cycle public use mictodata files which is based on a common survey template ·~~three~ area in canada, namely montreal, toronto, and vancouver. it also utili .es the built-m stanclatdizaaon of the nphs data which accounts for its complex survey design. . ~:the stu~ usc:s two well-known measures of health inequalitythe relative index of meqaality and die concentranon indexto capture the extent of income related health inequality among poster sessions v urban female and male populations in each of the three metropolitan areas. personal income is classified into ten groups by the nphs with "no income" as the first group and "more than $ , " as the last. health status is measured by three variables -having a chronic condition (chc), self assessed health (sah), and health utility index (hui) -using appropriate indices. alternative formulations are used to calculate the standard deviations of the estimated or calculated measures. the findings of the study suggest that the measured health inequality depends on the health measure used. for chc and hui the measured inequality indices do indicate poorer health for lower income individulas, however, they are not statistically insignificant. health inequalities are more pronounced when health is measured by sah. the results do not support any systematic ranking of the three metropolitan areas in terms of health inequalities. they do not reveal any systematic pattern of inequality between men and women, either. conclusions: despite the use of highly aggregated nphs data, income related health disparities are observed in the three metropolitan areas in canada. this is more the case with self perceived (sah) health. such disparities are preventable and call for broader health policies that address poverty and low income among other social determinants of health. introduction: the analysis of health indicators under the spatial perspective is configured as an important instrument in the detection of intra-urban differentials. this study aimed to examine the spatial distribution of the births occurred in belo horizonte, in , analyzing the presence of spatial clusters of health indicators for newborns (rn) and their mothers, using data from the information system on live birth database (sinasc). method: for each covered area of the basic units of health (ubs), we calculated the proportion of: adolescent mothers, mothers with less than years of schooling, first pregnancy, mothers with four or more pregnancies, dead babies born on previous pregnancies, stillbirths, cesarean section, less than four prenatal care attendance, moderate and severe hypoxemia in the st and th minutes of life, low or very low birth weight. we used empiric bayesian methods for smoothing the estimates. for spatial analysis, the indicators obtained from the global moran (i) index and local indicators of spatial association (lisa) were used. maps were built to allow the visualization of the spatial clusters. in all analysis, significance statistics was considered p~ . . results: a total of , births of residents in belo horizonte were registered in i. the estimated bayesian proportions for the entire municipality was close to the one observed for all variables. analysis using lisa showed the presence of relevant spatial clusters for adolescent and low educated mothers, dead babies form previous pregnancies, cesarean section, low attendance to the prenatal care especially in area with low socio-demographic characteristics. three areas presented consistent clusters, with important spatial auto-correlation for almost all studied indicators. conclusion: the used methodology was configured as a great instrument of detection risk areas where clustering occurs. it can easily be incorporated in any surveillance system as a mechanism for controlling events related to births in the municipality. moreover, it can be applied to discriminate target areas for prompt public health interventions, such as improving health services access and the consolidation of better obstetric practices. introduction: gentrification, the displacement of low income and non-majority people out of longtime neighborhoods and residences is a global phenomenon. it has been identified as occurring in both developed and less developed countries and as inequality persists or increases, many communities are vulnerable to disruption and loss. while there may be some benefits to gentrification, these benefits are less likely to impact those who have been forced to move out of a gentrifying community or those who remain but economically stressed. . . . . this paper lays out a theoretical framework for dent fymg and ~ddressm~. the_ health consequences of gentrification on residents living in a community prior .to o.r durmg gent~ ~ cat. n. by drawing on the literature of housing, sociology, health and urban plannmg, t places genmf catt~n and neighborhood change into the context of other forces affecting th~ .hea.lth of vulnerable populations. it then proposes solutions to prevent or mitigate the impacts of genmf cat on. results: four main categories of consequences potentiallr re~ult from ~entr~fica~~n: !'°°r housing· related issues, spatial effects, mental health impacts and contr bunons to racial ~spanttes m heal~. the housing issues include increased susceptibility to asthma, lead exposure, allergiesl~topy an~. acetdents/ injuries. spatial effects include reduced access to health ~are, reduce~ access to obslttadinonal food sources, decreased physical activity, and increased obesity. the __ pnmary mental health effects_ :ire increased stress increased risk of depression and disruption of trad t onal support networks. in addinon to the above he~lth issues, gentrification has the potential to increase racial disparities in health by reduc· ing access to long term and multi-culturally experienced health care provide~s. conclusions: public health practice provides a framework for addressmg the health consequences of gentrification. in this context primary prevention would involve preventing gentrification in the first place along with a renewed commitment to helping distressed communities a~~ im_proving the quality ~f life for long term residents. the next layer of meeting the challenges of gentrification would be to assjst long rime residents to stay in a community and thus potentially allowing them to participate in the bene~ts of gentrification (such as better public services). only if all these efforts fail -and these other prevennon strategies must be a priority, public policy should then work to help people and instirutions move to other communities through grants and the provision of alternative safe affordable housing and neighborhoods. sarah romans, marsha cohen, and tonia forte lnh'odlletion: there has been sustained interest in urban rural (ur) differences in mental health over the last years of epidemiological research, with most studies reporting higher urban rates of mor· bidity, particularly when psychotic disorders have been studied. most recently, in britain, urban rates of non-psychotic disorder were greater than rural and semi-rural rates, both before and after the more adverse circumstances of urban dwellers were considered (paykel et al ) . surprisingly, there were no ur differences in help seeking. in canada, wang ( ) found greater urban rates for major depression only after he controlled for the confounding effects of race, immigration, employment and marital status, a result reminiscent of work from the us (blazer et ) . rural participants were less likely to have sought help for their mental health problems. in this study, we sought to examine urban/rural differences in rates of depression and help seeking in canada. method; data came from the canadian community health survey . , a community survey conducted by statistics canada of people aged and older, with the total sample size of , respon· dents, % response. analyses used weighted data; differences were assessed by chi-squared. ra.its: bivariate cross-tabulations showed a modest increase in month depression rates for urban ( . %) over rural ( . %, p= . ) dwellers; there were no ur differences when the sample was examined separately by gender and age group ( - , - , - ) . in general, more urban ( . %) than rural people ( . %, p= . ) had sought mental health treatment in the past year. there was no ur difference in helping seeking amongst those with depression (u . %, r . % ns). amongst the whole population, helping seeking was gendered with more urban men accessing help ( . %) than rural men ( . %, p= . ); this did not apply for women ( . % vs . % p= . ). ~ons: the urban-rural demographic continues to generate intriguing findings, even recently when internal migration is common and people can seek out the environment most conducive to their health, ~th physical and mental. people with depression are a disadvantaged, frequently stigmatized group, with ~r quality of life a_nd often impaired function. unlike many other factors associated wi~h urban or rural hfe per se, depression can be treated. the low help seeking rates is a cause for concern, m both the ur~n and_ rural populations. it behooves researchers, policy makers and service planners to ensutt effective services are available for both humane and economic reasons. methods: using united states census income data, we assigned the manhattan community districts to two major socioeconomic groups, manhattan i and ii. manhattan i is composed of community districts with average household incomes above the median for new york city; manhattan ii is those below. with public new york city department of health death records and us census data, we calculated a "standard" new york city population and estimated mortality rate distributions for manhattan i and ii. we then compared these age-adjusted actual mortality distributions with a standard t-test. results: we explored premature deaths using several cut-off points (before the ages of , , and ), and with subcomparisons for males and females. every comparison showed the wealthier area, manhattan i, to have significantly lower premature mortality rates than the lower income manhattan ii. further, we compared age-adjusted mortality rates among the city's five boroughs, and found no significant differences based on local geography alone. conclusions: these findings suggest that in manhattan, characterized by its extremes of wealth and poverty, health status, as measured by premature mortality, does vary significantly with the local income level. in manhattan, the relative average income by community district varies as much as : . this ratio is greater than that found in the other cities we have studied: for example, the range among tokyo's kus is half that in manhattan, or about : . paris has shown the longest life expectancy and changing premature mortality rates. from our preliminary work, we expect to find less variation in premature mortality rates in comparable cities. this study will continue to explore the relationship of premature mortality rates and life expectancy to income levels and different health systems among wcp cities with a view to measuring health policy options. introduction: according to the world health organization (who), smoking-related illness is currently the world's second major cause of death, currently responsible for one out of ten adult deaths worldwide. the who's framework convention on tobacco control (fctc) aims to reduce tobaccorelated disease and deaths by changing national public policies. mexico, which, according to the who, had smoking prevalences of % among adults in and % among health care providers (hcps) in , ratified the fctc in . objective: to examine knowledge of and attitudes towards cigarette smoking and smoking cessation among hcps, and clinical practices regarding smoking cessation. methods: in june , a convenience sample of hcps from one public clinic in urban oaxaca, mexico, part of mexico's national network of public health care clinics, were interviewed in spanish using a verbally administered questionnaire that was standard among all participants. during primary care outpatient visits, hcps were observed treating patients to assess the relative importance of smoking cessation as a health care priority. results: of the hcps interviewed, including ten physicians, three nurses, and five medical students, % reported smoking regularly. all hcps reported assessing patients' history of smoking, knowledge of the health risks associated with smoking, and feeling qualified to discuss these risks with patients. all hcps reported counseling patients who currently smoked to quit. all hcps reported recommending nicotine replacement therapy (eg., patch and/or gum) and/or behavioral therapy (eg., psychologist, support groups) to patients who smoked. all hcps reported that there was no government funding for smoking cessation, and that all costs associated with smoking cessation were patients' out-of-pocket expenses. observation of hcp interaction with patients revealed that hcps always inquired about smoking history with new patients and rarely inquired about smoking history with returning patients. hcps were not observed counseling patients who reported current smoking on smoking cessation methods and its benefits. observation of the clinical environment suggested a focus on preventative child health (eg., immunization, water-borne illnesses), family planning, and chronic diseases (eg., diabetes, hypertension). conclusions: while the mexican government has made smoking cessation a public health priority and hcps report addressing smoking cessation, observation of hcps suggests: ) smoking status is assessed only in new patients; and ) smoking cessation methods are not addresse~. observ_atio~ of hcps and the clinical environment in a public clinic in oaxaca suggests that smoking cessation s of lower priority than other heath care issues. p - (a) urban agriculture and food and nutrition security in kampala, uganda fiona yeudall, renee sebastian, abdelrahman lubowa, selahadin ibrahim, and donald cole introduction: urban agriculture is an important livelihood strategy contributing to household food security by increasing access and availability to food in urban settings (koc et al., ) . the purpose of poster sessions v rhis study was to examine relationships between child nutritional securiry outcomes, household food security, and urban agriculture activiries in kampala, uga~da. . . questionnaires assessing socio-demographic, farmmg and household food secunry (hfsi characreristics were administered to households. food diversiry was ~lculate~ from ~e number of foods consumed over hours for one child ( - years) per household. heigh~ weight,. nud-upper·ann· circumference (muac) and tricep skinfolds (tsf) were measured for the mdex child. z-sc.ores for height-for·age (haz), weighr-for-age (waz) and body mass index (zbmi) were ~~ulated usmg cen· rres for disease control and prevenrion reference data. z-scores for body composition measures were calculated using nhanes i and ii data for african americans. the lms method was used to c~.t for skewed z·score indices. all dara was checked for normaliry and univariable and backward mulnvanablc linear regression analysis conducted. ruwlts: household food securiry was significantly associated with wealth (b= . , p< 'a acre were more dependenr on assets for hfs. although sex of head of household was ~ot related to j-:ifs, it modi· fied relationships in rhar female headed households had greater food securtry when fai:mmg less than , acre compared ro male headed households, and vice versa. hfs was significantly associated with food diversiry (s= . , p). urbanization, especially in developing countries, has substantially increased the vulnerability of rhe mass of low-income urban dwellers. the livelihoods and quality of life for many of the poor espe· cially in larin america, asia, and africa, have deteriorated significantly over the years. urban areas are increasingly unable to provide for their populations, resulting in poverry, massive unemploymenr, job cuts, poor housing, lack of or poor public services, and a compromised health status. botswana, a country rhat lies in the sourhern parr of africa, has had its share of urban problems such as rhe mush· rooming of squarters and low-income urban sertlements. despite efforts to address the substandard living conditions in low-income urban areas, these problems have continued to grow. these living con· diuons are porenrially stressful to rhe residenrs and likely affects their health. the primary aim of the udy wa to examine the complex relationship between communiry-level stressors and interveners and health-related quality of life among residents of low-income neighborhoods in francistown, botswana. u i"" a croa -icctional quantitative design (both descriptive and explanatory) and using primarily cloae-mded interview• with a random sample of residents, this study examined the role of chrome life trnson and environmental quality on overall health status qualiry of life) and the physical, psy· chological and level of independence domains of health. the major hypothesis of the study was that community-levrl stre sor would influence health-related quality of life and that social capital would moderate these relationships. findings indicate that neighborhood quality is a powerful predictor of healrh tatu rhan socioeconomic status and individual life stressors. social capital was also found to he a ificant positive predictor of healrh and also moderator of structural factors. social capital moderated the effects of low environmental quality on level of indrpendence and on physical health outcomn, but nor on psychological and global health outcomes. these findings suggest that as the environment get betttr. stresson are reduced, hence promoting berter health outcomes. the study ends with implication• for social justice, public health and social work practice, and research, focusing mostly on the ~ole of social capital and the environmental quality in predicting health outcomes. spt· cafically • anenhon should be focused on political and civic society's commitment for social justice and poveny alleviation, ~uction of the threat of insecuriry and violence; cultivating social capital and good governance; and improving the health and social environments, especially housing and environ· mental aiutanon to name a few. urban and other uprisings by non-elites that lead to transitions, can disrupt sexual and injection "risk" networks that transmit infectious diseases by changing mixing patterns. they can also weaken urban social networks, their associated protective norms and their informal social control mechanisms which can lead to increased sexual and drug risk behaviors and violence (fullilove ; wallace & wallace , aral , friedman & reid hankins et al ) . for example, the revolution and transition to theocratic rule, and subsequent urban and national conflicts, have been followed by many urban youth in iran engaging in clandestine high-risk sexual and drug behaviors. in palestine, conflicts and restrictions on movement have led to increased fatalities from chronic diseases due to limited access to hospitals and modern medical facilities (union of palestinian medical relief committees); and heroin use and violence-related blood exposure have also increased. social movements "from below" that are rooted both in urban social network dynamics and in underlying patterns of injustice can have both protective and risky effects. for example, the social movements that led to the collapse of the ussr and its dependent governments in other countries-with subsequent increases in sex trade, alcoholism, drug use, tuberculosis, hiv, stis, and mortality in many localities-were based originally on such city-based movements in eastern europe. their impacts on health were mediated by urban social dynamics and structures. some urban social movements have improved health by prevent· ing the spread of hiv, hepatitis and other diseases. examples include movements of (a) gays and lesbians and (b) drug users. these have been rooted in social networks that overlap with risk networks. theories of urban health should include social conflict as a core concept. mechanisms that generate conflicts and the pathways by which conflicts affect health should be a major part of urban health research agendas. p - (c) demographic characteristics of people seen with tuberculosis in lagos state university teaching hospital (lasuth) chest clinic john bako, adewale akeredolu, and wale alabi tuberculosis has become a resurgent public health problem in recent times in the world. because resources are limited, control programmes frequently must target population at greatest risk. the purpose of this study was to study the demographic characteristics of people seen with tuberculosis in lagos state university teaching hospital. a total of patients who have been both radiologically and bacteriologically confirmed tuberculosis patients were used for this study between january and march. ( %) were males, while ( %) were females. notable risk factors among patients with tuberculosis were overcrowding ( . % ), homelessness ( . %) cigarette smoking ( . % ), alcoholism ( . %), non vaccination ( %), secondary contact ( . %) and poor knowledge ( . l 'x,). man· agement history patterns among the patients were herbs ( . 'yo), orthodox medicine ( .h . .l'x.). intervention targeting early-identified groups may be an effective way to reduce the incidence of tuber· culosis. such intervention should focus on health education, modification of life style and improvement of standard of living. p - (c) profiles in urban health in cities of the americas in the countries of the americas, there is an increasing migration of national and international populations to urban centers. this presentation will focus on some of the issues created by this influx of populations, the ways that cities in countries are dealing with them, and the efforts to promote local participation and solutions in management and decision-making. the methodology used to collect this information has been to draw upon and analyze information produced by the mayor's and ministry of health and development offices in each of the cities under consideration. an analysis of the impact of urbanization on health and health determinants will be presented. the information covers issues such as health status by geographic areas within the cities, highlighting issues such as marginality, barriers and physical, economic and cultural constructs and inequities in the delivery of and access to essential services (such as health, education, water, and basic sanitation). issues of governance and citizen participation will be highlighted to provide insight in~o the balance of power and mechanisms for decision-making at the local level. part of the analysis will show the relationship between democratic processes and social participation. public ~olicies will be reviewed to indicate those that are most beneficial in promoting health and overcoming barriers to it, as well as ways of capitalizing on local assets and resources. final~y, evidence of effectiveness of various strategies will be indicated. the presentation will conclude wuh suggesuons for future strategic directions to improve the quality of life and the promotion of health in large urban centers of the americas. introduction: much of the illicit drug in mexico is concentrated in northern border areas. the mile border between the u.s. and mexico is also characterized by migration; the border crossing between tijuana, baja california, mexico and san diego, california, u.s.a. is rep~rt~dl~ the busiest land border crossing in the world. we attempt to describe the migration scene among m ect on drug users (idus) m tijuana and investigate service needs. methods: migration trends were investigated in a cross-sectional study conducted from february to june among idus in tijuana. enrollment criteria included informed consent, being years or older, and having injected drugs within the prior month. subjects were recruited by respondent-dnven sampling and were administered a quantitative survey and serology for hiv, hcv, and syphilis. logistic regression was used to compare idus who had migrated to the u.s. versus those who had not. results: of idus enrolled, % were male and median age and age at first injection were and , respectively. drug combinations injected most frequently in the past months were heroin ( % and crystal methamphetamine mixed with heroin ( %). of those enrolled, responded to quesnons on migration and drug treatment and were included in this analysis. although % had resided in tijuana for at least years, % of users were born outside of baja california. working outside of mexico was common, with % working abroad in the last years ( % in u.s.), and % in the past year. in the last months, % of idus had crossed the border to the u.s., with % crossing at least once per month. those working outside of mexico in the past year were less likely to have ever received substance abuse treatment, [ % vs. %, or . , ] and were marginally less likely to have received drug treatment in the past months [ % vs. %, or . , % ci ( . - . )]. drug use patterns, age and gender did not differ between migrants and non-migrants, although migrants were more likely to report being in need of substance abuse treatment ( % vs. %, respectively). conclusions: migration is common among idus in tijuana. maintaining drug treatment regimens and determining how to best target education and services to a highly mobile population pose challenges to officials on both sides of the border. these data underscore the need to develop coordinated binational prevention and treatment efforts. introduction: despite the expanding literature on the important role public policy plays in influencing the broader determinants of the public\'s health, profound differences exist among jurisdictions in rhe attention placed upon such activities. we take an international perspective on health by examining rhe d?minant public _health paradigms of canada, usa, uk, and sweden and exploring how these paradigms shape public health practice. _method: we carefully analyze governmental and public health agencies documents to discern ~he dommant para~igms driving public health approaches and practices. we also consider the unique paht · cal and economic contexts within each nation and consider how these contexts drive public health pahcy and approaches. . . ~u~: the canadian and usa public health communities -with some exceptions --focus upon m~ividuahzed approaches to risk management. in contrast, the uk and swedish public health scenes are oriented toward broader approaches to health determinants. we find that the extent to which govern· ments, public health agencies and public health workers concern themselves with public policy approaches £<_> ~ddress ~ro.ad~r .determinants of health depends upon the particular health parad'.~ adhered. ~o withm each urisd ctton. and whether a paradigm is adopted depends upon the ideologi~a and pol~ncal context of each nation. nations such as sweden that have a long tradition of public policies promonng social jus~ce an~ equity are naturally receptive to evolving population health concepts. '[he usa represen~ a ~bey en~ro~~t where such is~ues are clear!~ subordinate. ., our findings mdicate that there s a strong political component that influences pubh ~ealth a~proaches and practi~ within the jurisdictions examined. the implications are that those seek· m~ to raise the broader detennmants of the public's health should work in coalition to raise these issues with non-health organizations and age · ca d d th · - badrgrollnd: in developed countries, social inequalities in health have endured or even worsened comparatively throughout different social groups since the s. in france, a country where access to medical and surgical care is theoretically affordable for everyone, health inequalities are among the high· est in western europe. in developing countries, health and access to care have remained critical issues. in madagascar, poverty has even increased in recent years, since the country wenr through political crisis and structural adjustment policies. objectives. we aimed to estimate and compare the impact of socio· economic status but also psychosocial characteristics (social integration, health beliefs, expectations and representation, and psychological characteristics) on the risk of having forgone healthcare in these dif· fercnt contexts. methods: population surveys conducted among random samples of households in some under· served paris neighbourhoods (n= ) and in the whole antananarivo city (n= ) in , using a common individual questionnaire in french and malagasy. reslllts: as expected, the impact of socioeconomic status is stronger in antananarivo than in paris. but, after making adjustments for numerous individual socio-economic and health characteristics, we observed in both cities a higher (and statically significant) occurrence of reponed forgone healthcare among people who have experienced childhood and/or adulthood difficulties (with relative risks up to and .s respectively in paris and antananarivo) and who complained about unhealthy living conditions. in paris, it is also correlated with a lack of trust in health services. coneluions: aside from purely financial hurdles, other individual factors play a role in the non-use of healthcare services. health insurance or free healthcare seems to be necessary hut not sufficienr to achieve an equitable access to care. therefore, health policies must not only focus on the reduction of the financial barriers to healthcare, but also must be supplemented by programmes (e.g. outreach care ser· vices, health education, health promotion programmes) and discretionary local policies tailored to the needs of those with poor health concern .. acknowledgments. this project was supported by the mal>io project and the national institute of statistics (instat) in madagascar, and hy the development research institute (ird) and the avenir programme of the national institute of health and medical research (inserm) in france. for the cities of developing countries, poverty is often described in terms of the living standard~ of slum populations, and there is good reason to believe that the health risks facing these populations are even greater, in some instances, than those facing rural villagers. yet much remains to be learned ahour the connections between urban poverty and health. it is not known what percentage of all urban poor live in slums, that is, in communities of concentrated poverty; neither is it known what proportion of slum residents are, in fact, poor. funhermore, no quantitative accounting is yet available that would sep· arare the health risks of slum life into those due to a househoid•s own poverty and those stemminic from poveny in the surrounding neighborhood. if urban health interventions are to be effectively targeted in developing countries, substantial progress must be made in addressing these cenrral issues. this paper examines poverty and children's health and survival using two large surveys, one a demographic and health survey fielded in urban egypt (with an oversampling of slums) and the other a survey of the slums of allahabad, india. using multivariate statistical methods. we find, in both settings: ( substan· rial evidence of living standards heterogeneity within the slums; ( strong evidence indicating that household-level poverty is an imponant influence on health; and ( ) staristically significant (though less strong) evidence that with household living standards held constant, neighborhood levels of poverty adversely affect health. the paper doses with a discussion of the implications of these findings for the targeting of health and poverty program interventions. p - (a) urban environment and the changing epidemiological surfacr. the cardiovascular ~ &om dorin, nigeria the emergence of cardiovascular diseases had been explained through the concomitants o_f the demographic transition wherein the prevalent causes of morbidity and monality ~hangr pr~mmant infectious diseases to diseases of lifestyle or chronic disease (see deck, ) . a ma or frustration m the v poster sessions case of cvd is its multifactural nature. it is acknowledged that the environment, however defined is the d · f · t' b tween agents and hosts such that chronic disease pathogenesis also reqmre a me an o mterac ion e . spatio-temporal coincidence of these two parties. what is not clear is which among ~ever~( potennal fac· · h b pace exacerbate cvd risk more· and to what extent does the ep dem olog cal trans · tors m t e ur an s ' . . . . tion h othesis relevant in the explanation of urban disease outlook even the developmg cities like nigeri~: thesis paper explorer these within a traditional city in nigeria. . . . the data for the study were obtained from two tertiary level hospitals m the metropolis for years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the data contain reported cases of cvd in the two facilities for the period. adopting a series of parametric and non-parametric statistics, we draw inferences between the observed cases of cvds and various demographic and locational variables of the patients. findings: about % of rhe cases occurred in years ( ) ( ) ( ) coinciding with the last year of military rule with great instability. . % occurred among male. . % also occurred among people aged - years. these are groups who are also likely to engage in most stressful life patterns. ~e study also shows that % of all cases occurred in the frontier wards with minor city areas also havmg their •fair' share. our result conformed with many empirical observation on the elusive nature of causation of cvd. this multifactoral nature had precluded the production of a map of hypertension that would be consistent with ideas of spatial prediction. cvd -cardiovascular diseases. mumbai is the commercial capital of india. as the hub of a rapidly transiting economy, mumbai provides an interesting case study into the health of urban populations in a developing country. with high-rise multimillion-dollar construction projects and crowded slums next to each other, mumbai presents a con· trast in development. there are a host of hi-tech hospitals which provide high quality care to the many who can afford it (including many westerners eager to jump the queue in their healthcare systems-'medical tour· ism'), at the same time there is a overcrowded and strained public healthcare system for those who cannot afford to pay. voluntary organizations are engaged in service provision as well as advocacy. the paper will outline role of the voluntary sector in the context of the development of the healthcare system in mumbai. mumbai has distinct upper, middle and lower economic classes, and the health needs and problems of all three have similarities and differences. these will be showcased, and the response of the healthcare system to these will be documented. a rising hiv prevalence rate, among the highest in india, is a challenge to the mumbai public healthcare system. the role of the voluntary sector in service provision, advocacy, and empowerment of local populations with regards to urban health has been paramount. the emergence of the voluntary sector as a major player in the puzzle of urban mumbai health, and it being visualized as voices of civil society or communiry representatives has advantages as well as pitfalls. this paper will be a unique attempt at examining urban health in india as a complex web of players. the influence of everyday socio·polirical-cultural and economic reality of the urban mumbai population will be a cross cutting theme in the analysis. the paper will thus help in filling a critical void in this context. the paper will thus map out issues of social justice, gender, equiry, effect of environment, through the lens of the role of the voluntary sector to construct a quilt of the realiry of healthcare in mumbai. the successes and failures of a long tradi· tion of the active advocacy and participation of the voluntary sector in trying to achieve social justice in the urban mumbai community will be analyzed. this will help in a better understanding of global urban health, and m how the voluntary sector/ngos fir into the larger picture. ba~und: o~er. half _of n~irobi's . million inhabitants live in illegal informal settlements that compose yo of the city s res dent al land area. the majority of slum residents lack access to proper san· iranon and a clean and adequate water supply. this research was designed to gain a clearer understand· mg of what kappr · · · h f . . opnate samtanon means or the urban poor, to determine the linkages between gender, hvehhoods, and access to water and sanitation, and to assess the ability of community sanitation blocks to meet water and sanitation needs in urban areas. m~tbojs_: _a household survey, gender specific focus groups and key informant interviews were conducted m maih saba, a peri-urban informal settlement. qualitative and quantitative research tools were u~ to asses~ the impact and effectiveness of community sanitation blocks in two informal settlements. results ropna e samtarmn me u es not only safe and clean latrines, but also provision ° adequate drainage and access to water supply for cleaning of clothes and homes. safety and cleanliness poster sessions v were priorities for women in latrines. levels of poverty within the informal settlements were identified and access to water and sanitation services improved with increased income. environmental health problems related to inadequate water and sanitation remain a problem for all residents. community sanitation blocks have improved the overall local environment and usage is far greater than envisioned in the design phase. women and children use the blocks less than men. this is a result of financial, social, and safety constraints. the results highlight the importance a need to expand participatory approaches for the design of water and sanitation interventions for the urban poor. plans need to recognize "appropriate sanitation" goes beyond provision of latrines and gender and socioeconomic differences must be taken into account. lessons and resources from pilot projects must be learned from, shared and leveraged so that solutions can be scaled up. underlying all the challenges facing improving water and sanitation for the urban poor are issues of land tenure. p - (c) integrating tqm (total quality management), good governance and social mobilization principles in health promotion leadership training programmes for new urban settings in countries/ areas: the prolead experience susan mercado, faren abdelaziz, and dorjursen bayarsaikhan introduction: globalization and urbanization have resulted in "new urban settings" characterized by a radical process of change with positive and negative effects, increased inequities, greater environmental impacts, expanding metropolitan areas and fast-growing slums and vulnerable populations. the key role of municipal health governance in mitigating and modulating these processes cannot be overemphasized. new and more effective ways of working with a wide variety of stakeholders is an underpinning theme for good governance in new urban settings. in relation to this, organizing and sustaining infrastructure and financing to promote health in cities through better governance is of paramount importance. there is a wealth of information on how health promotion can be enhanced in cities. despite this, appropriate capacity building programmes to enable municipal players to effectively respond to the challenges and impacts on health of globalization, urbanization and increasing inequity in new urban settings are deficient. the who kobe centre, (funded by the kobe group( and in collaboration with regional offices (emro, searo, wpro) with initial support from the japan voluntary contribution, developed a health promotion leadership training programme called "prolead" that focuses on new and autonomous structures and sustainable financing for health promotion in the context of new urban settings. methodology: country and/or city-level teams from areas, (china, fiji, india, japan, lebanon, malaysia, mongolia, oman, philippines, republic of korea, tonga and viet nam) worked on projects to advance health promotion infrastructure and financing in their areas over a month period. tools were provided to integrate principles of total quality management, good governance and social mobili .ation. results: six countries/areas have commenced projects on earmarking of tobacco and alcohol taxes for health, moblization of sports and arts organizations, integration of health promotion and social health insurance, organizational reforms, training in advocacy and lobbying, private sector and corporate mobilization and community mobilization. results from the other six areas will be reported in ..;obcr. conclusions: total quality management, good governance and social mobilization principles and skills are useful and relevant for helping municipal teams focus on strategic interventions to address complex and overwhelming determinants of health at the municipal level. the prolead training programmes hopes to inform other processes for building health promotion leadership capacity for new urban settings. the impact of city living and urbanization on the health of citizens in developing countries has received increasing attention in recent years. urban areas contribute largely to national economies. however, rapid and unplanned urban growth is often associated with poverty, environmental degradation and population demands that outstrip service capacity which conditions place human health at risk. local and national governments as well as multi national organizations are all grappling with the challenges of urbanization. with limited data and information available, urban health characteristics, including the types, quantities, locations and sources in kampala, are largely unknown. moreover, there is n? basis for assessing the impact of the resultant initiatives to improve health ~onditions amo~g ~o": ": um ties settled in unplanned areas. since urban areas are more than the aggregation ?f ~?pie w~th md_ v dual risk factors and health care needs, this paper argues that factors beyond the md v dual, mcludmg the poster sessions v · i d h · i · ment and systems of health and social services are determinants of the health soc a an p ys ca environ . of urban populations. however, as part of an ongoing study? ~s pape~ .addresses the basic concerns of urban health in kampala city. while applying the "urban hvmg conditions and the urban heal~ pen· alty" frameworks, this paper use aggregated urban health d~ta t~ explore the role of place an~ st tu· tions in shaping health and well-being of the population m kampala by understanding how characteristics of the urban environment and specific features of the city are causally related to health of invisible and forgotten urban poor population: results i~dica~e that a .range o~ urb~n he~l~h hazards m the city of kampala include substandard housing, crowdmg, mdoor air poll.ut on, msuff c ent a~d con· taminated water, inadequate sanitation and solid waste management services, vector borne .diseases, industrial waste increased motor vehicle traffic among others. the impact of these on the envtronment and community.health are mutually reinforcing. arising out of the withdra"'.al of city pl~nning systems and service delivery systems or just planning failure, thousands of people part cularl~ low-mc~me groups have been pushed to the most undesirable sections of the city where they are faced with ~ va_r ety ~f envj· ronmental insults. the number of initiatives to improve urban health is, however, growing mvolvjng the interaction of many sectors (health, environment, housing, energy, transportation and urban planning) and stakeholders (local government, non governmental organizations, aid donors and local community groups). key words: urban health governance, health risks, kampala. introduction: the viability of urban communities is dependent upon reliable and affordable mass transit. in particular, subway systems play an especially important role in the mass transit network, since they provide service to vast numbers of ridersseven of the subway systems worldwide report over one billion passenger rides each year. surprisingly, given the large number of people potentially affected, very little is known about the health and safety hazards that could affect both passengers and transit workers; these include physical (e.g., noise, vibration, accidents, electrified sources, temperature extremes), biological (e.g., transmission of infectious diseases, either through person-to-person spread or vector-borne, for example, through rodents), chemical (e.g., exposure to toxic and irritant chemicals and metals, gas emissions, fumes), electro-magnetic radiation, and psychosocial (e.g., violence, workstress). more recently, we need to consider the threat of terrorism, which could take the form of a mass casualty event (e.g., resulting from conventional incendiary devices), radiological attack (e.g., "dirty bomb"), chemical terrorist attack (e.g., sarin gas), or bioterrorist attack (e.g., weapons grade anthrax). given the large number of riders and workers potentially at risk, the public health implications are considerable. methods: to assess the hazards associated with subways, a structured review of the (english) litera· ture was conducted. ruults: based on our review, non-violent crime, followed by accidents, and violent crimes are most prevalent. compared to all other forms of mass transit, subways present greater health and safety risks. however, the rate of subway associated fatalities is much lower than the fatality rate associated with automobile travel ( . vs. . per million passenger miles), and cities with high subway ridership rates have a % lower per capita rate of transportation related fatalities than low ridership cities ( . versus . annual deaths per , residents). available data also suggest that subway noise levels and levels of air pollutants may exceed recommended levels. . ~: there is a paucity of published research examining the health and safety hazards associated with subways. most of the available data came from government agencies, who rely on passively reported data. research is warranted on this topic for a number of reasons, not only to address important knowled~ gaps, but also because the population at potential risk is large. importantly, from an urban perspecnve, the benefits of mass transit are optimized by high ridership ratesand these could be adversely affu:ted by unsafe conditions and health and safety concerns. veena joshi, jeremy lim. and benjamin chua ~ ~rban health issues have moved beyond infectious diseases and now centre largely on chrome diseases. diabetes is one of the most prevalent non-communicable diseases globally. % of adult ¥ benefit in providing splash pads in more parks. given the high temperature and humidity of london summers, this is an important aspect and asset of parks. interviewed parents claimed to visit city parks anywhere between to days per week. corrduion: given that the vast majority of canadian children are insufficiently active to gain health benefits, identifying effective qualities of local parks, that may support and foster physical activity is essential. strategies to promote activity within children's environments are an important health initiative. the results from this study have implications for city planners and policy makers; parents' opinions of, and use of city parks provides feedback as to the state current local parks, and modifications that should be made for new ones being developed. this study may also provide important feedback for health promoters trying to advocate for physical activity among children. introdt clion: a rapidly increasing proportion of urban dwellers in africa live below the poverty line in overcrowded slums characterized by uncollected garbage, unsafe water, and deficient sanitation and overflowing sewers. this growth of urban poverty challenges the commonly held assumption that urban populations enjoy better health than their rural counterparts. the objectives of this study are (i) to compare the vaccination status, and morbidity and mortality outcomes among children in the slums of nairobi with rural kenya, and (ii) to examine the factors associated with poor child health in the slums. we use data from demographic and health survey representative of all slum settlements in nairobi city carried out in by the african population & health research center. a total of , women aged - from , households were interviewed. our sample consists of , children aged - months. the comparison data are from the kenya demographic and health survey. the outcomes of interest include child vaccination status, morbidity (diarrhea, fever and cough) and mortality, all dichotomized. socioeconomic, environmental, demographic, and behavioral factors, as well as child and mother characteristics, are included in the multivariate analyses. multilevel logistic regression models are used. l'nlimin ry rest lts: about % of children in the slums had diarrhea in the two weeks prior to the survey, compared to % of rural children. these disparities between the urban poor anj the rural residents are also observed for fever ( % against %), cough ( % versus %), infant mortality ( / against / ), and complete vaccination ( % against %). preliminary multivariate results indicate that health service utilization and maternal education have the strongest predictive power on child morbidity and mortality in the slums, and that household wealth has only minor, statistically insignificant effects. conclruion: the superiority of health of urban children, compared with their rural counterparts, masks significant disparities within urban areas. compared to rural residents, children of slum dwellers in nairobi are sicker, are less likely to utilize health services when sick, and stand greater risk to die. our results suggest policies and programs contributing to the attainment of the millennium development goal on child health should pay particular attention to the urban poor. the insignificance of socioeconomic status suggests that poor health outcomes in these communities are compounded by poor environmental sanitation and behavioral factors that could partly be improved through female education and behavior change communication. introduction: historic trade city surat with its industrial and political peace has remained a center of attraction for people from all the comers of india resulting in to pop.ulatio~ explosio~ a~d stressed social and service infrastructure. the topography,dimate and demographic profile of the city s threat to the healthy environment. aim of this analysis is to review the impact of managemt'nt reform on health indicators. method: this paper is an analysis of the changing profile of population, sanitary infr~s~rucrure, local self government management and public health service reform, secondary health stat st cs data, health indicator and process monitoring of years. . . health of entire city and challenge to the management system. plague outbr~ak ( ) was the turning point in the history of civic service management including p~blic ~e~lth service management. ~ocal self government management system was revitalized by reg~lar_ field v s ts o~ al~ cadre~, _decentraltzanon of power and responsibility, equity, regular vigilant momtormg, commumcanon facility, ream_approach and people participation. reform in public health service management was throu_gh stan~~rd zed intervention protocol, innovative intervention, public private partnership, community part c panon, academic and service institute collaboration and research. sanitation service coverage have reached nearer to universal. area covered by safe water supply reached to %( ) from % ( ) and underground drainage to % ( ) from % ( ) the overhauling of the system have reflected on health indicators of vector and water born disease. malaria spr declined to . ( ) from . 'yo(! ) and diarrhea case report declined to ( ) from ( ). except dengue fever in no major disease outbreaks are reported after . city is recipient of international/national awards/ranking for these achievements. the health department have developed an evidence and experience based intervention and monitoring system and protocol for routine as well as disaster situation. the health service and management structure of surat city have emerged as an urban health model for the country. introduction: the center for healthy communities (chc) in the department of family and com· munity medicine at the medical college of wisconsin developed a pilot project to: ) assess the know· ledge, attitudes, and behaviors of female milwaukee public housing residents related to breast cancer; develop culturally and literacy appropriate education and screening modules; ) implement the developed modules; ) evaluate the modules; and ) provide follow-up services. using a community-based participatory research model the chc worked collaboratively with on-site nurse case management to meet these objectives. methods: a "breast health kick off event" was held at four separate milwaukee public housing sites for elderly and disabled adults. female residents were invited to complete a -item breast health survey, designed to accommodate various literacy levels. responses were anonymous and voluntary. the survey asked women about their previous physical exams for breast health, and then presented a series of state· ments about breast cancer to determine any existing myths. the final part gathered information about personal risk for breast cancer, the highest level of education completed, and whether the respondents h;td ever used hormone replacement therapy and/or consumed alcohol. responses were collected for descriptive analysis. results: a total of surveys (representing % of the total female population in the four sites) were completed and analyzed. % reported that they had a physical exam in the previous rwo years. % of respondents indicated they never had been diagnosed with breast cancer. % reported having had a mammogram and % having had a clinical breast exam. those that never had a mammogram reported a fear of what the provider would discover or there were not any current breast problems ro warrant an exam. % agreed that finding breast cancer early could lower the chance of dying of cancer. over % reported that mammograms were helpful in finding cancer. however, % believed that hav· ing a mammogram actually prevents breast cancer. % indicated that mammograms actually cause cancer and % reported that a woman should get a mammogram only if there is breast cancer in her family. conclusion: this survey indicates that current information about the importance of mammograms and clinical breast exams is reaching traditionally underserved women. yet there are still critical oppor· tunities to provide valuable education on breast health. this pilot study can serve as a tool for shaping future studies of health education messages for underserved populations. located in a yourh serv· ~ng agency m downtow~ ottawa, the clinic brings together community partners to provide primary medical care. and dent~i hygiene t? the street youths of ottawa aged - . the primary goal of the project is to provide accessible, coordinated, comprehensive health and dental care to vulnerable adolescents. these efforts respond to the pre-existing body of evidence suggesting that the principle barrier in accessing such care for these youths are feelings of intimidation and vulnerability in the face of a complex healthcare system. the bruyere fhn satellite clinic is located in the basement of a downtown drop-in and brings together a family medicine physician and her residents, a dental hygienist and her nd year students, a nurse practitioner, a chiropodist and public health nurses to provide primary care. the clinic has been extremely busy and well received by the youth. this workshop will demonstrate how five community organizations have come together to meet the needs of high risk youths in ottawa. this presentation will showcase the development of the clinic from its inception through its first year including reaction of the youths, partnerships and lessons learned. it will also focus on its sustainability without continued funding. we hope to have developed a model of service delivery that could be reproduced and sustained in other large cities with faculties of medicine. methods: non-randomized, mixed method design involving a process and impact evaluation. data collection-qualitative-a) semi structured interviews with providers & partners b)focus groups with youth quantitative a)electronic medical records for months records (budget, photos, project information). results: ) successfully built and opened a medicaudental clinic which will celebrate its year anniversary in august. ) over youths have been seen, and we have had over visits. conclusion: ) the clinic will continue to operate beyond the month project funding. ) the health of high risk youth in ottawa will continue to improve due to increased access to medical services. p - (a) health services -for the citizens of bangalore -past, present and future savita sathyagala, girish rao, thandavamurthy shetty, and subhash chandra bangalore city, the capital of karnataka with . million is the th most populous city in india; supporting % of the urban population of karnataka, it is considered as one of the fastest growing cities in india. known as the 'silicon valley of india', bangalore is nearly years old. bangalore city corporation (bmp), is a local self government and has the statutory commitment to provide to the citizens of bangalore: good roads, sanitation, street lighting, safe drinking water apart from other social obligations, cultural development and poverty alleviation activities. providing preventive and promotive heahh services is also a specific component. the objective of this study was to review the planning process with respect to health care services in the period since india independence; the specific research questions being what has been the strategies adopted by the city planners to address to the growing needs of the population amidst the background of the different strategies adopted by the country as a whole. three broad rime ranges have been considered for analysis: the s, s and the s. the salient results are: major area of focus has been on the maternal and child care with activities ranging from day-care to in-patient-care; though the number of institutions have grown from to the current day , their distribution has been far from satisfactory; obtaining support from the india population projects and major upgradarions have been undertaken in terms of infrastructure; over the years, in addition to the dispensaries of modern system of medicine, local traditional systems have also been initiated; the city has partnered with the healthy cities campaign with mixed success; disease surveillance, addressing the problems related to the emerging non-communicable diseases including mental health and road traffic injuries are still in its infancy. isolated attempts have been made to address the risks groups of elderly care and adolescent care. what stands out remarkably amongst the cities achievements is its ability to elicit participation from ngos, cbos and neighbourhood groups. however, the harnessing of this ability into the health sector cannot be said totally successful. the moot question in all the above observed development are: has the city rationally addressed it planning needs? the progress made so far can be considered as stuttered. the analysis and its presentation would identify the key posirive elements in the growth of banglore city and spell a framework for the new public health. introduction: anaemia associated with pregnancy is a major public health problem all over the world. different studies in different parts of india shown prevalence of anaemia between - %. anaemia remains a serious health problem in pregnancy despite of strong action taken by the government of india through national programmes. in the present study we identified th~ social beha~iors, responsible for low compliance of if a tablets consumption in pregnancy at community level and intervention was given with new modified behaviors on trial bases. . in vadodara urban. anganwadies out of were selected from the list by random sampling for tips (trials of improved practices) study. . . participants: pregnant women ( , intervention group+ , control. group) registered m the above anganwadies. study was conducted in to three phases: phase: . formative research and baseline survey (frbs). data was collected from all pregnant women to identify behaviors that are responsible for low compliance of ifa tablets. both qualitative and quantitative data were collected. haemoglobin was estimated of all pregnant women by haemo-cue. phase: . phase of tips. behaviors were identified both social & clinical for low compliance of ifa tablets consumption in pregnancy from frbs and against those, modified behaviors were proposed to pregnant women in the intervention group on trial bases by health education. trial period of weeks was given for trial of new behaviors to pregnant women in the interven· tion group. phase: . in this phase, feedbacks on behaviors tried or not tried were taken from pregnant women in intervention group. haemoglobin estimation was carried out again in all pregnant women. at the end of the study, messages were formulated on the bases of feedbacks from the pregnant women. results: all pregnant women in the intervention group had given positive feedback on new modified behaviors after intervention. mean haemoglobin concentration was higher in intervention group ( . ± . gm%) than control group ( . ± . gm%). ifa tablets compliance was improved in intervention group ( . %) than control group ( . %). conclusion: all pregnant women got benefits after trial of new modified behaviors in the intervention group. messages were formulated from the new modified behaviors, which can be used for longterm strategies for anaemia control in the community. introduction: in order to develop a comprehensive mch handbook for pregnant women and to assess its effect among them, a pilot study was carried out at the maternal and child health training institute (mchti), in dhaka, bangladesh. methods: from mchti a sample of pregnant women was selected and all subjects were women who were attending the first visit of their current pregnancy by using a random sampling method. of the subjects, women were given the mch handbook as case and women were not given the handbook as control. data on pre and post intervention of the handbook from the cases and controls were taken from data recording forms between the st of november and st of october, and data was analysed by using a multilevel analysis approach. this was a hospital-based action (case-control) research, and was applied in order to measure the outcome of pre and post intervention following the introduction of the handbook. data was used to assess the effects of utilisation of the handbook on women's knowledge, practice and utilisation of mch services. results: this study showed that the change of knowledge about antenatal care visits was . % among case mothers. knowledge of danger signs improved . %, breast feeding results . %, vaccination . % and family planning results improved . % among case. results showed some positive changes in women's attitudes among case mothers and study showed the change of practice in antenatal care visits was .u. % in the case. other notable changes were: change of practice in case mother's tetanus toxoid (ti), . %; and family planning . %. in addition, handbook assessment study indicated that most women brought the handbook on subsequent visits ( . %), the handbook was highly utilised (i.e. it was read by . %, filled-in by . %, and was used as a health education tool by . %). most women kept the handbook ( . %) and found it highly useful ( . %) with a high client satisfaction rate of . %. conclusion: pregnant women in the case group had higher knowledge, better practices, and higher utilisation of mch services than mothers in the control groups who used alternative health cards. if the handbook is developed with a focus on utilising a problem-oriented approach and involving the recomendations .of end~users, it is anticipated that the mch handbook will contribute significantly to ensuring the quahry of hfe of women and their children in bangladesh. after several meetmgs to identify the needs of the community, a faso clinic was opened at ncfs. health care professionals from smh joined with developmental and social service workers from ncfs to implement the faso diagnostic process and to provide culturally appropriate after-care. the clinic is unique in that its focus is the high risk urban aboriginal population of toronto. it accepts referrals of not only children and youth, but also of adults. lessons learned: response to the faso clinic at native child and family services has been overwhelming. aboriginal children with f asd are receiving timely diagnosis and interventions. aboriginal youth and adults who have been struggling with poveny, substance abuse, and homelessness are more willing to enter the ncfs centre for diagnosis and treatment. aboriginal infants prenatally exposed to alcohol born at st. michael's hospital or referred by other centres have access to the developmental programs located in both of the partnering agencies. the presentation will describe the clinic's development, and will detail the outcomes described, including interventions unique to the aboriginal culture. p - (c) seeds, soil, and stories: an exploration of community gardening in southeast toronto carolin taran, sarah wakefield, jennifer reynolds, and fiona yeudall introduction: community gardens are increasingly seen as a mechanism for improving nutrition and increasing food security in urban neighbourhoods, but the evidence available to support these claims is limited. in order to begin to address this gap in a way that is respectful of community knowledge and needs, the urban gardening research opportunities workgroup (ugrow) project explored the benefits and potential risks of community gardening in southeast toronto. the project used a community-based research (cbr) model to assess community gardens as a means of improving local health. the research process included interviews, focus groups, and participant observation (documented in field notes). we also directly engaged the community in the research process, through co-learning activities and community events which allowed participants to express their views and comment on emerging results. most of the research was conducted by a community-based research associate, herself a community gardener. key results were derived from these various sources through line-by-line coding of interview transcripts and field note review, an interactive and iterative process which involved both academic and community partners. results: these various data sources all suggest that enhanced health and access to fresh produce are important components of the gardening experience. they also highlight the central importance of empowering and community-building aspects of gardening to gardeners. community gardens were thought to play a role in developing friendships and social support, sharing food and other resources, appreciating cultural diversity, learning together, enhancing local place attachment and stewardship, and mobilizing to solve local problems (both inside and outside the garden). potential challenges to community gardens as a mechanism for communiry development include bureaucratic resistance to gardens, insecure land tenure and access, concerns about soil contamination, and a lack of awareness and under· standing by community members and decision-makers of all kinds. conclusion: the results highlight many health and broader social benefits experienced by commu· nity gardeners. they also point to the need for greater support for community gardening programs, par· ticularly ongoing the ongoing provision of resources and education programs to support gardens in their many roles. this research project is supported by the wellesley central health corporation and the centre for urban health initiatives, a cihr funded centre for research development hased at the univer· sity of toronto. p - (c) developing resiliency in children living in disadvantaged neighbourhoods sarah farrell, lorna weigand, and wayne hammond the traditional idea of targeting risk reduction by focusing on the development of eff~ctive coping strategies and educational programs has merit in light of the research reportmg_ that_ ~ lupl.e forms of problem behaviour consistently appear to be predicted by increasing exposure to den_uf able risk factors. as a result, many of the disadvantaged child and youth studies have focused on trymg to better _unde.r· stand the multiple risk factors that increase the likelihood of the development of at nsk behaviour m ch ldren/youth and the potential implications for prevention. this in turn has led t_o. the conclus on that community and health programs need to focus on risk reduction by helpm~ md v duals develop more effective coping strategies and a better understanding of the limitations of cenam pathologies, problematic v poster sessions coping behaviours and risk factors potentially inheren~ in high needs co~unities. ~owever, another ai:ea of research has proposed that preventative interventions should cons de~ .~rotecnve fa~ors alo~~ with reducing risk factors. as opposed to just emphasizing problems, vulnerab ht es, and deficits, a res liencybased perspective holds the belief that children, youth and their families. have strengths, reso~ce.s and the ability to cope with significant adversity in ways that are not only effective, but tend to result m mcreased ability to constructively respond to future adversity. with this in mind, a participatory research project sponsored by the united way of greater toronto was initiated to evaluate and determine the resiliency profiles of children - years (n = ) of recent immigrant families living in significantly disadvantaged communities in the toronto area. the presentation will provide an overview of the identified protective factors (both intrinsic and extrinsic) and resiliency profiles in an aggregated format as well as a summary of how the children and their parents interpreted and explained these strength-based results. as part of the focus groups, current community programs and services were examined by the participants as to what might be best practices for supporting the development and maintaining of resiliency in children, families and communities. it was proposed that the community model of assessing resiliency and protective factors as well as proposed best strength-based practice could serve as a guide for all in the community sector who provide services and programs to those in disadvantaged neighbourhoods. p - (c) naloxone by prescription in san francisco, ca and new york, ny emalie huriaux the harm reduction coalition's overdose project works to reduce the number of fatal overdoses to zero. located in new york, ny and san francisco, ca, the overdose project provides overdose education for social service providers, single-room occupancy hotel (sro) residents, and syringe exchange participants. the project also conducts an innovative naloxone prescription program, providing naloxone, an opiate antagonist traditionally administered by paramedics to temporarily reverse the effects of opiate overdose, to injection drug users (idus). we will describe how naloxone distribution became a reality in new york and san francisco, how the project works, and our results. the naloxone prescription program utilizes multiple models to reach idus, including sro-and street-based trainings, and office-based trainings at syringe exchange sites. trainings include information on overdose prevention, recognition, and response. a clinician conducts a medical intake with participants and provides them with pre-filled units of naloxone. in new york, funding was initially provided by tides foundation. new york city council provides current funding. new york department of mental health and hygiene provides program oversight. while the new york project was initiated in june , over half the trainings have been since march . in san francisco, california endowment, tides foundation, and san francisco department of public health (sfdph) provide funding. in addition, sfdph purchases naloxone and provides clinicians who conduct medical intakes with participants. trainings have been conducted since november . to date, nearly individuals have been trained and provided with naloxone. approximately of them have returned for refills and reported that they used naloxone to reverse an opiate-related overdose. limited episodes of adverse effects have been reported, including vomiting, seizure, and "loss of friendship." in new york, individuals have been trained and provided with naloxone. over overdose reversals have been reported. over half of the participants in new york have been trained in the south bronx, the area of new york with the highest rate of overdose fatalities. in san francisco, individuals have been trained and provided with naloxone. over overdose reversals have been reported. the majority of the participants in san francisco have been trained in the tenderloin, th street corridor, and mission, areas with the highest rates of overdose fatalities. the experience of the overdose project in both cities indicates that providing idus low-threshold access to naloxone and overdose information is a cost-effective, efficient, and safe intervention to prevent accidental death in this population. p - (c) successful strategies to regulate nuisance liquor stores using community mobilization, law enforcement, city council, merchants and researchers tahra goraya presenta~ion _will discuss ~uccessful environmental and public policy strategies employed in one southen: cahf?rmna commumty to remedy problems associated with nuisance liquor stores. participants ~ be given tools to understand the importance of utilizing various substance abuse prevention str~tegi~ to change local policies and the importance of involving various sectors in the community to a~_ st with and advocate for community-wide policy changes. recent policy successes from the commultles of pa~ad~na and altad~na will highlight the collaborative process by which the community mobilized resulnng m several ordmances, how local law enforcement was given more authority to monitor poster sessions v nonconforming liquor stores, how collaborative efforts with liquor store owners helped to remove high alcohol content alcohol products from their establishments and how a community-based organiz,uion worked with local legislators to introduce statewide legislation regarding the regulation of nuisance liquor outlets. p - (c) "dialogue on sex and life": a reliable health promotion tool among street-involved youth beth hayhoe and tracey methven introduction: street involved youth are a marginalized population that participate in extremely risky behaviours and have multiple health issues. unfortunately, because of previous abuses and negative experiences, they also have an extreme distrust of the adults who could help them. in , toronto public health granted funding to a non governmental, nor for profit drop-in centre for street youth aged - , to educate them about how to decrease rhe risk of acquiring hiv. since then the funding has been renewed yearly and the program has evolved as needed in order to target the maximum number of youth and provide them with vital information in a candid and enjoyable atmosphere. methods: using a retrospective analysis of the six years of data gathered from the "dialogue on sex and life" program, the researchers examined the number of youth involved, the kinds of things discussed, and the number of youth trained as peer leaders. also reviewed, was written feedback from the weekly logs, and anecdotal outcomes noted by the facilitators and other staff in the organization. results: over the five year period of this program, many of youth have participated in one hour sessions of candid discussion regarding a wide range of topics including sexual health, drug use, harm reduction, relationship issues, parenting, street culture, safety and life skills. many were new youth who had not participated in the program before and were often new to the street. some of the youth were given specific training regarding facilitation skills, sexual anatomy and physiology, birth control, sexually transmitted infections, hiv, substance use/abuse, harm reduction, relationships and discussion of their next steps/future plans following completion of the training. feedback has been overwhelmingly positive and stories of life changing decisions have been reported. conclusion: clearly, this program is a successful tool to reach street involved youth who may otherwise be wary of adults and their beliefs. based on data from the evaluation, recommendations have been made to public health to expand the funding and the training for peer leaders in order ro target between - new youth per year, increase the total numbers of youth reached and to increase the level of knowledge among the peer leaders. p - (c) access to identification and services jane kali replacing identification has become increasingly more complex as rhe government identification issuing offices introduce new requirements rhar create significant barriers for homeless people to replace their id. new forms of identification have also been introduced that art' not accessible to homekss peoplt-(e.g. the permanent resident card). ar rhe same time, many service providers continue to require identifi· cation ro access supports such as income, housing, food, health care, employment and employmt·nt training programs. street health, as well as a number of other agencies and community health centres, h, , been assisting with identification replacement for homeless peoplt· for a number of years. the rnrrt·nr challenges inherent within new replacement requirements, as well as the introduction of new forn ' of identification, have resulted in further barriers homeless people encounter when rrring to access t:ssential services. street health has been highlighting these issues to government identification issuing offices, as well as policy makers, in an effort to ensure rhar people who are homeless and marginalized have ac'ess to needed essential services. bandar is a somali word for •·a safe place." the bandar research project is the product of the regent park community health centre. the research looks ar the increasing number of somali and afri· can men in the homeless and precariously house population in the inner city core of down~own toronto. in the first phase of the pilot project, a needs assessment was conducted to dennfy barners and issues faced by rhe somali and other african men who are homeless and have add cr ns issues. th_e second phase of rhe research project was to identify long rerm resources and service delivery mechamsms that v poster sessions would enhance the abiity of this population to better access detox, treatment, and post treatment ser· vices. the final phase of the project was to facilitate the development of a conceptual model of seamless continual services and supports from the streets to detox to treatment to long term rehabilitation to housing. "between the pestle and mortar" -safe place. p - (c) successful methods for studying transient populations while improving public health beth hayhoe, ruth ewert, eileen mcmahon, and dan jang introduction: street youth are a group that do not regularly access healthcare because of their mis· trust of adults. when they do access health care, it is usually for issues severe enough for hospitalization or for episodic care in community clinics. health promotion and illness prevention is rarely a part of their thinking. thus, standard public health measures implemented in a more stable population do not work in this group. for example, pap tests, which have dearly been shown to decrease prevalence of cer· vical cancer, are rarely done and when they are, rarely followed up. methods to meet the health care needs and increase the health of this population are frequently being sought. methods: a drop-in centre for street youth in canada has participated in several studies investigating sexual health in both men and women. we required the sponsoring agencies to pay the youth for their rime, even though the testing they were undergoing was necessary according to public health stan· dards. we surmised that this would increase both initial participation and return. results: many results requiring intervention have been detected. given the transient nature of this population, return rates have been encouraging so far. conclusion: it seems evident that even a small incentive for this population increases participation in needed health examinations and studies. it is possible that matching the initial and follow-up incentives would increase the return rate even further. the fact that the youth were recruited on site, and not from any external advertising, indicates that studies done where youth trust the staff, are more likely to be successful. the presentation will share the results of the "empowering stroke prevention project" which incor· porated self-help mutual aids strategies as a health promotion methodology. the presentation will include project's theoretical basis, methodology, outcomes and evaluation results. self-help methodology has proven successful in consumer involvement and behaviour modification in "at risk," "marginalized" settings. self-help is a process of learning with and from each other which provides participants oppor· tunities for support in dealing with a problem, issue, condition or need. self-help groups are mechanisms for the participants to investigate existing solutions and discover alternatives, empowering themselves in this process. learning dynamic in self-help groups is similar to that of cooperative learning and peertraining, has proven successful, effective and efficient (haller et al, ) . the mutual support provided by participation in these groups is documented as contributory factor in the improved health of those involved. cognizant of the above theoretical basis, in the self-help resource centre initiated the "empowering stroke prevention project." the project was implemented after the input from health organizations, a scan of more than resources and an in-depth analysis of risk-factor-specific stroke prevention materials indicated the need for such a program. the project objectives were:• to develop a holistic and empowering health promotion model for stroke prevention that incorporates selfhelp and peer support strategies. • to develop educational materials that place modifiable risk factors and lifestyle information in a relevant context that validates project participants' life experiences and perspectives.• to educate members of at-risk communities about the modifiable risk factors associated with stroke, and promote healthy living. to achieve the above, a diverse group of community members were engaged as "co-editors" in the development of stroke prevention education materials which reflected and validated their life experiences. these community members received training to become lay health promoters (trained volunteer peer facilitators). in collaboration with local health organizations, these trained lay health promoters were then supported in organizing their own community-based stroke prevention activities. in addition, an educational booklet written in plain language, entitled healthy ways to prevent stroke: a guide for you, and a companion guide called healthy ways to pre· vent stroke: a facilitator's guide were produced. the presentation will include the results of a tw<>tiered evaluation of the program methodology, educational materials and the use of the materials beyond the life of the project. this poster presentation will focus on the development and structure of an innovative street outreach service that assists individuals who struggle mental illness/addictions and are experiencing homelessness. the mental health/outreach team at public health and community services (phcs) of hamilton, ontario assists individuals in reconnecting with health and social services. each worker brings to the ream his or her own skills-set, rendering it extremely effective at addressing the multidimensional and complex needs of clients. using a capacity building framework, each ream member is employed under a service contract between public health and community services and a local grassroots agency. there are public health nurses (phn), two of whom run a street health centre and one of canada's oldest and most successful needle exchange programs, mental health workers, housing specialists, a harm reduction worker, youth workers, and a united church minister, to name a few. a community advisory board, composed of consumers and professionals, advises the program quarterly. the program is featured on raising the roors 'shared learnings on homelessness' website at www.sharedlearnings.ca. through our poster presentation participants will learn how to create effective partnerships between government and grassroots agencies using a capacity building model that builds on existing programs. this study aims to assess the effects of broadcasting a series of documentary and drama videos, intended to provide information about the bc healthguide program in farsi, on the awareness about and the patterns of the service usage among farsi-speaking communities in the greater vancouver area. the major goals of the present study were twofold; ( ) to compare two methods of communications (direct vs. indirect messages) on the attitudes and perceptions of the viewers regarding the credibility of messengers and the relevance of the information provided in the videos, and ( ) to compare and contrast the impact of providing health information (i.e., the produced videos) via local tvs with the same materials when presented in group sessions (using vcr) on participants' attitudes and perceptions cowards the bc healrhguide services. results: through a telephone survey, farsi-speaking adults were interviewed in november and december . the preliminary findings show that % of the participants had seen the aired videos, from which, % watched at least one of the 'drama' clips, % watched only 'documentary' clip, and % watched both types of video. in addition, % of the respondents claimed that they were aware about the program before watching the aired videos, while % said they leaned about the services only after watching the videos. from this group, % said they called the bchg for their own or their "hildren's health problems in the past month. % also indicated that they would use the services in the future whenever it would be needed. % considered the videos as "very good" and thought they rnuld deliver relevant messages and % expressed their wish to increase the variety of subjects (produ\:e more videos) and increase the frequency of video dips. conclusion: the results of this study will assist public health specialists in bc who want to choose the best medium for disseminating information and apply communication interventions in multi\:ultural communities. introduction: many theorists and practitioners in community-based research (cbr) and knowledge transfer (kt) strongly advocate for involvement of potential users of research in the development of research projects, yet few examples of such involvement exist for urban workplace health interventions. we describe the process of developing a collaborative research program. methods: four different sets of stakeholders were identified as potential contributors to and users of the research: workplace health policy makers, employers, trade unions, and health and safety associations. representatives of these stakeholders formed an advisory committee which met quarterly. over the month research development period, an additional meetings were held between resc:ar~h~rs and stakeholders. in keeping with participant observation approaches, field notes of group and md v ~ ual meetings were kept by the two co-authors. emails and telephone calls were also documented. qu~h tative approaches to textual analysis were used, with particular attention paid to collaborattve v poster sessions relationships established (as per cbr), indicators of stakeholders' knowledge utilization (as per kt), and transformations of the proposed research (as per cbr). results: despite initial strong differences of opinion both among stakeho~ders .an~ between stakeholders and researchers, goodwill was noted among all involved. acts of rec~proc ty included mu.rual sharing of assessment tools, guidance on data utilization to stakeho~der orga~ zat ns, and suggestions on workplace recruitment to researchers. stakeholders demonstrated mcreases m concep~ual. un~erstand ing of workplace health e.g. they more commonly discussed more complex,. psychosocial md cators of organizational health. stakeholders made instrumental use of shared materials based on research e.g. adapting their consulting model to more sophisticated dat~ analysis. sta~ehol?~rs recogni_zed the strategic use of their alliance with researchers e.g., transformational leadership trainmg as a~ inducement to improve health and safety among small service franchises. stakeholders helped re-define the research questions, dramatically changed the method of recruitment from researcher cold call to stakeholderbased recruitment, and strongly influenced pilot research designs. owing a great deal to the elaborate joint development process, the four collaboratively developed pilot project submissions which were all successfully funded. conclusion: the intensive process of collaborative development of a research program among stakeholders and researchers was not a smooth process and was time consuming. nevertheless, the result of the collaborative process was a set of projects that were more responsive to stakeholder needs, more feasible for implementation, and more broadly applicable to relevant workplace health problems. introduction: environmental groups, municipal public health authorities and, increasingly, the general public are advocating for reductions in pesticide use in urban areas, primarily because of concern around potential adverse health impacts in vulnerable populations. however, limited evidence of the relative merits of different intervention strategies in different contexts exists. in a pilot research project, we sought to explore the options for evaluating pesticide reduction interventions across ontario municipalities. methods: the project team and a multi-stakeholder project advisory committee (pac), generated a list of potential key informants (kl) and an open ended interview guide. thirteen ki from municipal government, industry, health care, and environmental organizations completed face to face or telephone interviews lasting - minutes. in a parallel process, a workshop involving similar representatives and health researchers was held to discuss the role of pesticide exposure monitoring. minutes from pac meetings, field notes taken during ki interviews, and workshop proceedings were synthesized to generate potential evaluation methods and indicators. results: current evaluation activities were limited but all kls supported greater evaluation effons beginning with fuller indicator monitoring. indicators of education and outreach services were imponant for industry representatives changing applicator practices as well as most public health units and environmental organizations. lndictors based on bylaw enforcement were only applicable in the two cities with bylaws, though changing attitudes toward legal approaches were being assessed in many communities. the public health rapid risk factor surveillance system could use historical baseline data to assess changes in community behaviour through reported pesticide uses and practices, though it had limited penetration in immigrant communities not comfortable in english. pesticide sales (economic) data were only available in regional aggregates not useful for city specific change documentation. testing for watercourse or environmental contamination might be helpful, but it is sporadic and expensive. human exposure monitoring was fraught with ethical issues, floor effects from low levels of exposure, and prohibitive costs. clinical episodes of pesticide exposure reported to the regional poison centre (all ages) or the mother risk program (pregnant or breastfeeding women) are likely substantial underestimates that would be need to be supplemented with sentinel practice surveillance. focus on special clinical populations e.g., multiple chemical sensitivity would require additional data collection efforts . . conc~ons: broad support for evaluation and multiple indicators were proposed, though con-s~raints associate~ with access, coverage, sensitivity and feasibility were all raised, demonstrating the difficulty of evaluating such urban primary prevention initiatives. interventionists. an important aim of the youth monitor is to learn more about the health development of children and adolescents and the factors that can influence this development. special attention is paid to emo· tional and behavioural problems. the youth monitor identifies high-risk groups and factors that are associated with health problems. at various stages, the youth monitor chancrs the course of life of a child. the sources of informa· tion and methods of research are different for each age group. the results arc used to generate various kinds of repons: for children and young persons, parents, schools, neighbourhoods, boroughs and the municipality of rotterdam and its environs. any problems can be spotted early, at borough and neigh· bourhood level, based on the type of school or among the young persons and children themselves. together with schools, parents, youngsters and various organisations in the area, the municipal health service aims to really address these problems. on request, an overview is offered of potentially suitable interventions. the authors will present the philosophy, working method, preliminary effects and future developments of this instrument, which serves as the backbone for the rotterdam local youth policy. social workers to be leaders in response to aging urban populations: the practicum partnership program sarah sisco, alissa yarkony, and patricia volland "'" tliu:tion: across the us, . % of those over live in urban areas. these aging urban popu· lations, including the baby boomers, have already begun encounter a range of heahh and mental hcahh conditions. to compound these effects, health and social service delivery fluciuates in cities, whit:h arc increasingly diverse both in their recipients and their systems. common to other disciplines (medicine, nursing, psychology, etc.) the social work profession faces a shortage of workers who are well-equipped to navigate the many systems, services, and requisite care that this vast population requires. in the next two decades, it is projected that nearly , social workers will be required to provide suppon to our older urban populations. social workers must be prepared to be aging-savvy leaders in their field, whether they specialize in gerontology or work across the life span. mllhotu: in , a study conducted at the new york academy of medicine d<> :umcntcd the need for improved synchroniciry in two aspects of social work education, classroom instruction and the field experience. with suppon from the john a. hanford foundation, our team created a pilot proj~"t entitled the practicum pannership program (ppp) in master's level schools of social work, to improvt" aginr exposure in field and classroom content through use of the following: i) community-university partnrr· ships, ) increased, diverse student field rotations, ll infusion of competcn ."}'·drivm coursework, enhancement of field instructors' roles, and ) concentrated student recruitment. we conductt"d a prr· and post-test survey into students' knowledge, skills. and satisfaction. icarlja: surveys of over graduates and field inltnk."tors rcflected increased numlk-n of . rrm:y· univmity panncrships, as well as in students placed in aging agencin for field placements. there wa marked increase in student commitments to an aging specialization. onr year por.t·gradu:nion rcvealrd that % of those surveyed were gainfully employed, with % employed in the field of aginic. by com· bining curricular enhancement with real-world experiences the ppp instilled a broad exposurr for llu· dents who worked with aging populations in multiple urban settings. coltdtuion: increased exposure to a range of levels of practicr, including clinical, policy/ajvocaq, and community-based can potentially improve service delivery for older adulh who live in elfin, and potentially improve national policy. the hanford foundation has now elected to uppon cxpantion of the ppp to schools nationwide (urban and rural) to complement other domntic initiatives to cnhalk"c" holistic services for older adults across the aging spectrum. bodrgnn.ntl: we arc a team of rcscarcbcn and community panncn working tcj c(her to develop an in"itepth understanding of the mental health needs of homeless youth ~ages to ) (using qualiutivc and quantitative methods ' panicipatory rncarch methods). it is readily apparmt that '-neless youth cxpcricnce a range of mental health problems. for youth living on the street, menul illnew may be either a major risk factor for homelessnal or may frequently emcsge in response to coping with rhe multitudinous stressors associated with homclcslllcsi including exposure to violence, prasutt to pamaplte in v poster sessions survival sex and/or drug use. the most frequent psychiatric diagnoses amongst the homeless gencrally include: depression, anxiety and psychosis. . . . the ultimate ob ective of the pr~am of rei:e~ is to ~evelop a plan for intervention to meet the mental health needs of street youth. prior t_o pl~nnmg mtervenbons, .it is necessary to undertake a comprehensive assessment ~f mental health needs m this ~lnerable populanon. thus, the immediate objective of this research study is to undertake a comprehensive assessment of men· tal health needs. . . melbotlology: a mixed methodology triangulating qualitative, participatory acnon and quantitative methods will capture the data related to mental health needs of homeless youth. a purposive sample of approximately - subjecrs. ages to , is currently being ~ted ~participate from the commu.nity agencies covenant house, evergreen centre fo~ srrc;et youth, turning p? ?t and street ~ serv~. youth living on the street or in short -term residennal programs for a mmimum of month pnor to their participation; ages to and able to give infonned consent will be invited to participate in the study. o..tcomes: the expected outcome of this initial survey will be an increased understanding of mental health needs of street youth that will be used to develop effective interventions. it is anticipated that results from this study will contribute to the development of mental health policy, as well as future programs that are relevant to the mental health needs of street youth. note: it is anticipated that preliminary quantitative data ( subjects) and qualitative data will be available for the conference. the authors intend to present the identification of the research focus, the formation of our community-based team, relevance for policy, as well as preliminary results. p - (a) the need for developing a firm health policy for urban informal worken: the case of despite their critical role in producing food for urban in kenya, urban farmers have largely been ignored by government planners and policymakers. their activity is at best dismissed as peripheral eveo, inappropriate retention of peasant culture in cities and at worst illegal and often some-times criminal· ized. urban agriculture is also condemned for its presumed negative health impact. a myth that contin· ues despite proof to the contrary is that malarial mosquitoes breed in maize grown in east african towns. however, potential health risks are insignificant compared with the benefits of urban food production. recent studies too rightly do point to the commercial value of food produced in the urban area while underscoring the importance of urban farming as a survival strategy among the urban poor, especially women-headed households. since the millennium declaration, health has emerged as one of the most serious casualties consequent on the poverty, social exclusion, marginalisation and lack of sustain· able development in africa. hiv/aids epidemic poses an unprecedented challenge, while malaria, tuber· culosis, communicable diseases of childhood all add to the untenable burden. malnutrition underpins much ill-health and is linked to more than per cent of all childhood deaths. kenya's urban poor people ~ace ~ h~ge burde~ of preventable and treatable health problems, measured by any social and bi~ medical md cator, which not only cause unnecessary death and suffering, but also undermine econonuc development and damage the country's social fabric. the burden is in spite of the availability of suitable tools and re:c=hnology for prevention and treatment and is largely rooted in poverty and in weak healah •rstems. this pa~ therefore challenges development planners who perceive a dichotomy instead of con· tmuum between informal and formal urban wage earners in so far as access to health services is con· cemed. it i~ this gap that calls for a need to developing and building sustainable health systems among the urban mformal ~wellers. we recommend a focus on an urban health policy that can build and strengthen the capacity of urban dwellers to access health services that is cost-effective and sustainable. such ~ health poli<=>: must strive for equity for the urban poor, displaced or marginalized; mobilise and effect ~ely use sufficient sustainable resources in order to build secure health systems and services. special anenti_on. should ~ afforded hiv/aids in view of the unprecedented challenge that this epidemic poses to africa s economic and social development and to health services on the continent. methods: a review of the literature led us to construct three simple models and a composite model of exposure to traffic. the data were collected with the help of a daily diary of travel activities using a sample of cyclists who went to or come back from work or study. to calculate the distance, the length of journey, and the number of intersections crossed by a cyclist different geographic information systems (gis) were operated. statistical analysis was used to determine the significance between a measure of exposure on the one hand, and the sociodemographic characteristics of the panicipants or their geographic location on the other hand. restlltj: our results indicate that cyclists were significantly exposed to road accidents, no matter of where they live or what are their sociodemographic characteristics. we also stress the point that the fact of having been involved in a road accident was significantly related to the helmet use, but did not reduce the propensity of the cyclists to expose themselves to the road hazards. condlllion: the efforts of the various authorities as regards road safety should not be directed towards the reduction of the exposure of the vulnerable users, but rather towards the reduction of the dangers to which they could face. keywords: cyclist, daily diary of activities, measures of exposure to traffic, island of montreal. p - (a) intra urban disparities and environmental health: some salient features of nigerian residential neighbourhoods olumuyiwa akinbamijo intra urban disparities and environmental health: some salient features of nigerian residential neighbourhoods abstract urbanization panicularly in nigerian cities, ponends unprecedented crises of grave dimensions. from physical and demographic viewpoints, city growth rates are staggering coupled with gross inabilities to cope with the consequences. environmental and social ills associated with unguarded rapid urbanization characterize nigerian cities and threaten urban existence. this paper repons the findings of a recent study of the relationship between environmental health across inrraurban residential communities of akure, south west nigeria. it discuses the typical urbanization process of nigerian cities and its dynamic spatial-temporal characteristics. physical and socio-demographic attributes as well as the levels and effectiveness of urban infrastructural services are examined across the core residential districts and the elite residential layouts in the town. the incidence rate of cenain environmentally induced tropical diseases across residential neighborhoods and communes is examined. salient environmental variables that are germane to health procurement in the residential districts, incidence of diseases and diseases parasitology, diseases prevention and control were studied. field data were subjected to analysis ranging from the univariate and bivariate analysis. inferential statistics using the chi-square test were done to establish the truthfulness of the guiding hypothesis. given the above, the study affirms that there is strong independence in the studied communities, between the environment and incidence of diseases hence health of residents of the town. this assertion, tested statistically at the district levels revealed that residents of the core districts have very strong independence between the environment and incidences of diseases. the strength of this relationship however thins out towards the city peripheral districts. the study therefore concludes that since most of the city dwellers live in urban deprivation, urban health sensitive policies must be evolved. this is to cater for the urban dwellers who occupy fringe peripheral sites where the extension of facilities often times are illegally done. urban infrastructural facilities and services need be provided as a matter of public good for which there is no exclusive consumption or access even for the poorest of the urban poor. many suffer from low-self esteem, shame and guilt about their drug use. in addition, they often lack suppon or encounter opposition from their panners, family and friends in seeking treatment. these personal barriers are compounded by fragmented addiction, prenatal and social care services, inflexible intake systems and poor communication among sectors. the experience of accessing adequate care between services can be overwhelming and too demanding. the toronto centre for substance use in pregnancy (t-cup) is a unique program developed to minimize barriers by providing kone-stop" comprehensive healthcare. t-cup is a primary care based program located in the department of family medicine at st. joseph\'s health centre, a community teaching hospital in toronto. the interdisciplinary staff provides prenatal and addiction services, case management, as well as care of newborns affected by substance use. regular care plan meetings are held between t-cup, labour and delivery nurses and social workers in the y poster sessions maternity and child care program. t-cup also connects "'.omen with. inpatient treatment programs and community agencies such as breaking the cycle, an on-site counselmg group for pregnant substance users. · f · d d h ith method: retrospective chart review, qualitative patient ~ans action stu ~· an ea care provider surveys are used to determine outcomes. primary outcomes mclude changes m maternal su~tance use, psychosocial status and obstetrical complications (e.g. pre-rupture of membrane, pre-eclampsia, placen· ral abruption and hemorrhage). neonatal measures ~~nsisted of .bir~h pa_rame~ers, length of h~spital st.ay and complications (e.g. feral distress, meconium stammg, resuscitation, aund ce, hypoglycemia, seventy of withdrawal and treatment length). chart review consisted of all t-cup patients who met clinical cri· reria for alcohol or drug dependence and received prenatal and intra-partum care at st. joseph's from october to june . participants in the qualitative study included former and current t-cup patients. provider surveys were distributed on-site and to a local community hospital. raulb: preliminary evaluation has demonstrated positive results. treatment retention and satisfaction rates were high, maternal substance use was markedly reduced and neonatal outcomes have shown to be above those reported in literature. conclusion: this comprehensive, primary care model has shown to be optimal in the management of substance use in pregnancy and for improving neonatal outcomes. future research will focus on how this inexpensive program can be replicated in other health care settings. t-cup may prove to be the optimal model for providing care to pregnant substance users in canada. lntrod ction: cigarette smoking is one of the most serious health problems in taiwan. the prevalence of smoking in is . % in males . % in females aged years and older. although the government of taiwan passed a tobacco hazards control act in , it has not been strongly enforced in many places. therefore, community residents have often reported exposure of second hand smoke. the purpose of the study was to establish a device to build up more smoke-free environments in the city of tainan. methods: unique from traditional intervention studies, the study used a healthy city approach to help build up smoke-free environments. the major concept of the approach is to build up a healthy city platform, including organizing a steering committee, setting up policies and indicators, creating intersectoral collaboration, and increasing community participation. first, more than enthusiastic researchers, experts, governmental officers, city counselors and community leaders in tainan were invited in the healthy city committee. second, smoke-free policies, indicators for smoke-free environments, and mechanisms for inter-departmen· tal inspections were set up. third, community volunteers were recruited and trained for persuading related stakeholders. lastly, both penalties and rewards were used for help build up the environments. raults: aher two-year ( aher two-year ( - execution of the project, the results qualitatively showed that smoke-free environments in tainan were widely accepted and established, including smoke-free schools, smoke-free workpla~es, smoke-free households, smoke-free internet shops, and smoke-free restaurants. smoke~s were. effectively educated not to smoke in public places. community residents including adults and children m the smoke-free communities clearly understand the adverse effects of environmental tobacco smoke and actively participated anti-smoking activities. conclruions: healthy city platform is effective to conquer the barrier of limited anti-smoking rc:sources. nor. only can it enlar:ge community actions for anti-smoking campaigns, but also it can provide par_merships for collaboratjon. by establishing related policies and indicators the effects of smoke· free environments can be susta ·ned a d th · · · ' · n e progression can be monitored m a commuruty. these issues are used ~· oi::c it~ goals, weuha identifies issues that put people's health at risk. presently, team com~u:c: ran ee~tion !earns. (iats) that design integrative solutions ~tesj'°~ g om six to fifteen members. methods in order to establish wo-poster sessions v projects for weuha, the following approach was undertaken: i. a project-polling template was created and sent to all members of the alliance for their input. each member was asked to identify thdr top two population groups, and to suggest a project on which to focus over a - month period for each identified population. . there was a % response to the poll and the top three population groups were identified. data from the toronto community health profile database were utilized to contextualize the information supplied for these populations. a presentation was made to the steering committee and three population-based projects were selected, leaders identified and iats formed. three population-based projects: the population-based projects and health care issues identified are: newcomer prenatal uninsured women; this project will address the challenges faced by providers to a growing number of non-insured prenatal women seeking care. a service model where the barrier of "catchments" is removed to allow enhanced access and improved and co-ordinated service delivery will be pilot-tested. children/obesity/diab etes: using a health promotion model this team will focus on screening, intervention, and promoting healthy lifestyles (physical activity and nutrition) for families as well as for overweight and obese children. seniors health promotion and circle of discharge: this team will develop an early intervention model to assist seniors/family unit/caregivers in accessing information and receiving treatment/care in the community. the circle of discharge initiative will address ways of utilizing community supports to keep seniors in the community and minimize readmissions to acute care facilities. results/expected outcomes: coordinated and enhanced service delivery to identified populations, leading to improved access, improved quality of life, and health care for these targeted populations. introduction: basic human rights are often denied to high-risk populations and people living with hiv/aids. their rights to work and social security, health, privacy, non discrimination, liberty and freedom of movement, marriage and having a family have been compromised due to their sero-positive status and risk of being positive. the spread of hiv/aids has been accelerating due to the lack of general human rights among vulnerable groups. to formulate and implement effective responses needs dialogue and to prevent the epidemic to go underground barriers like stigma need to be overcome. objective: how to reduce the situation of stigma, discrimination and human rights violations experienced by people living with hiv/aids and those who are vulnerable to hiv/aids. methodology and findings: consultation meetings were strm.-rured around presentations, field visits, community meetings and group work to formulate recommendations on how govt and ngos/cbos should move forward based on objective. pakistan being a low prevalence country, the whole sense of compl;u:enc.:y that individuals are not subject to situations of vulnerable to hiv is the major threat to an explosion in th•· epidemic, therefore urgent measures are needed to integrate human rights issues from the very start of the response. the protection and promotion of human rights in an integral component of ;tll responses to the hiv/aids epidemic. it has been recognized that the response to hiv/aios must he multi sectoral and multi faceted, with each group contributing its particular expertise. for this to occur along with other knowlcdg<" more information is required in human rights abuses related to hiv/ aids in a particular scenario. the ~·on sultarion meetings on hiv/aids and human rights were an exemplary effort to achieve the same ohj<..:tivc. recommendations: the need for a comprehensive, integrated and a multi-sectoral appro;u.:h in addressing the issue of hiv/aids was highlighted. the need social, cultural and religious asp•·ct' to he: prominently addressed were identified. it was thought imperative measures even in low prevalence countries. education has a key role to play, there is a need for a code of ethics for media people and h<"alth care providers and violations should be closely monitored and follow up action taken. p - (c) how can community-based funding programs contribute to building community capacity and how can we measure this elusive goal? mary frances maclellan-wright, brenda cantin, mary jane buchanan, and tammy simpson community capacity building is recognized by the public health agency of canada (phac) as an important strategy for improving the overall health of communities by enabling communities to addre~s priority issues such as social and economic determinants of health. in / phac.:, alberta/nwf region's population health fund (phf) supported community-based projects to build community capacity on or across the determinants of health. specifically, this included creating accessible and sup· portive social and physical environments as well as creating tools and processes necessary for healthy policy development and implementation. the objective of this presentation is to highlight how the community capacity building tool, developed by phac ab/nwf region, can demonstrate gains in v poster sessions · · the course of a pror· ect and be used as a reflective tool for project planning and community capacity over . . . . i · a art of their reporting requirements, pro ect sites completed the community caparny eva uanon. s p . . th t i ii i'd d . building tool at the beginning and end of their ~ne-year prorect. e oo ~o ects va an reliable data in the context of community-based health prorects. developed through a vigorous ~nd collabora ve research process, the tool uses plain languag~ to expl~re nine key f~atures o~ commuruty cap~city with 't ch with a section for contextual information, of which also mdude a four-pomt raong ems, ea f fu d · scale. results show an increase in community capacity over the course o the nde prorects. pre and post aggregate data from the one-year projects measure~ statistic.ally si~n~ficant changes for of the scaled items. projects identified key areas of commumty capacity bmldmg that needed strengthemng, such as increasing participation, particularly among people with low incomes; engaging community members in identifying root causes; and linking with community groups. in completing the tool, projects examined root causes of the social and economic determinants of health, thereby exploring social justice issues related to the health of their community. results of the tool also served as a reflec· cion on the process of community capacity building; that is, how the project outcomes were achieved. projects also reported that the tool helped identify gaps and future directions, and was useful as a project planning, needs assessment and evaluation tool. community capacity building is a strategy that can be measured. the community capacity building tool provides a practical means to demonstrate gains in community capacity building. strengthening the elements of community capacity building through community-based funding can serve as building blocks for addressing other community issues. needs of marginalized crack users lorraine barnaby, victoria okazawa, barb panter, alan simpson, and bo yee thom background: the safer crack use coalition of toronto (scuc) was formed in in response to the growing concern for the health and well-being of marginalized crack users. a central concern was the alarm· ing hepatitis c rate ( %) amongst crack smokers and the lack of connection to prevention and health ser· vices. scuc is an innovative grassroots coalition comprised of front-line workers, crack users, researcher! and advocates. despite opposition and without funding, scuc has grown into the largest crack specific harm reduction coalition in canada and developed a nationally recognized sarer crack kit distribution program (involving community-based agencies that provide outreach to users). the success of our coalition derives from our dedication to the issue and from the involvement of those directly affected by crack use. setting: scuc's primary service region is greater toronto, a diverse, large urban centre. much ofour work is done in areas where homeless people, sex trade workers and drug users tend to congregate. recently, scuc has reached out to regional and national stakeholders to provide leadership and education. mandate: our mandate is to advocate for marginalized crack users and support the devdopmentof a com.p.rehensive harm reduction model that addresses the health and social needs facing crack users; and to fac htare the exchange of information between crack users, service providers, researchers, and policy developers across canada. owrview: the proposed workshop will provide participants with an overview of the devdopment of scuc, our current projects (including research, education, direct intervention and consultation), our challenge~ and s~ccesses and the role of community development and advocacy within the coalition. pre-senter~ will consist of community members who have personal crack use experience and front-line work· ers-, sc.uc conducted a community-based research project (toronto crack users perspectives, ) , in w~ich s focus groups with marginalized crack users across toronto were conducted. participants iden· t f ed health and social issues affecti h b · · · d " red . . ng t em, arrsers to needed services, personal strategies, an oue recommendations for improved services. presenters will share the methodology, results and recommen· datmns resulting from the research project. conc/usio": research, field observations and consultations with stakeholders have shown that cradck shmoke~s are at an. increased risk for sexually transmitted infections hiv/aids hepatitis c, tb an ot er serious health issues health · ff, · ' ' · · . · issues a ectmg crack users are due to high risk behavmurs, socio· economic factors, such as homeless d. · · · · d · . . ness, scrsmmat on, unemployment, violence incarceraoons, an soc a so at on, and a lack of comprehe · h i h · ' ns ve ea t and social services targeting crack users. · · sinct · s, owever arge remains a gross underesurnaoon. poster sessions v these are hospital-based reports and many known cases go unreported. however teh case, young age at first intercourse, inconsistent condom use and multiple partnersplace adolescents at high risks for a diverse array of stls, including hiv. about % of female nigerian secondary school students report initiating sexual intercourse before age years. % of nigerian female secondary school students report not using a condom the last time they had sexual intercourse. more than % of urban nigerian teens report inconsistent condom use. methods: adolescents were studied, ages to , from benin city in edo state. the models used were mother-daughter( ), mother -son( ), father -son ( ), and father-daughter( ). the effect of parent-child sexual communicationat baseline on child\'s report of sexual behavior, to months later were studied. greater amounts of sexual risk communication were asociated with markedly fewer episodes of unprotected sexual intercourse, reduced number of sexual partners and fewer episodes of unprotected sexual intercourse. results: this study proved that parents can exert more influence on the sexual knowledge attitudes and practise of their adolescent children through desired practises or rolemodeling, reiterating their values and appropriate monitoring of the adolescents\' behavior. they also stand to provide information about sexuality and various sexual topics. parental-child sexual communication has been found to be particularly influential and has been associated with later onset of sexual initiation among adolescents, less sexual activity, more responsible sexual attitudes including greater condom use, self efficacy and lower self -reported incidence of stis. conclusions: parents need to be trained to relate more effectively with their children/wards about issues related to sex and sexuality. family -based programs to reduce sexual risk-taking need to be developed. there is also the need to carry out cross-ethnicaland cross-cultural studies to identify how parent-child influences on adolescent sexual risk behavior may vary in different regions or countries, especially inthis era of the hiv pandemic. introduction: public health interventions to identify and eliminate health disparities require evidence-based policy and adequate model specification, which includes individuals within a socioecological context, and requires the integration of biosociomedical information. multiple public and private data sources need to be linked to apportion variation in health disparities ro individual risk factors, the health delivery system, and the geosocial environment. multilevel mapping of health disparities furthers the development of evidence-based interventions through the growth of the public health information network (phin-cdc) by linking clinical and population health data. clinical encounter data, administrative hospital data, population socioenvironmental data, and local health policy were examined in a three-level geocoded multilevel model to establish a tracking system for health disparities. nj has a long established political tradition of "home rule" based in elected municipal governments, which are responsible for the well-being of their populations. municipalities are contained within counties as defined by the us census, and health data are linked mostly at the municipality level. marika schwandt community organizers from the ontario coaliti~n again~t pove~, .along ":ith ~edical practitioners who have endorsed the campaign and have been mvolved m prescnbmg special diet needs for ow and odsp recipients, will discuss the raise the rates campaign. the organizati~n has used a special diet needs supplement as a political tool, meeting the urgent needs o.f .poor ~ople m toront~ while raising the issues of poverty as a primary determinant of health and nutrtnous diet as a preventative health mea· sure. health professionals carry the responsibility to ensure that they use all means available to them to improve the health of the individuals that they serve, and to prevent future disease and health conditions. most health practitioners know that those on social assistance are not able to afford nutritious foods or even sufficient amounts of food, but many are not aware of the extra dietary funds that are available aher consideration by a health practitioner. responsible nurse practitioners and physicians cannot, in good conscience, ignore the special needs diet supplement that is available to all recipients of welfare and disabiliry (ow and odsp). a number of toronto physicians have taken the position that all clients can justifiably benefit from vitamins, organic foods and high fiber diets as a preventative health measure. we know that income is one of the greatest predictors of poor health. the special needs diet is a health promotion intervention which will prevent numerous future health conditions, including chronic conditions such as cardiovascular disease, cancer, diabetes and osteoporosis. many communiry health centres and other providers have chosen to hold clinics to allow many patients to get signed up for the supplement at one time. initiated by the ontario coalition against poverty, these clinics have brought together commu· niry organizers, community health centers, health practitioners, and individuals, who believe that poverty is the primary determinant of poor health. we believe that rates must be increased to address the health problems of all people on social assistance, kids, elders, people with hiv/aids -everyone. even in the context of understaffing, it could be considered a priority activity that has potentially important health promotion benefits. many clients can be processed in a two hour clinic. most providers find it a very interesting, rewarding undertaking. in the ontario coalition for social justice found that a toronto family with two adults and two kids receives $ , . this is $ , below the poverty line. p - (c) the health of street youth compared to similar aged youth beth hayhoe and ruth ewert . lntrod~on: street youth are at an age normally associated with good health, but due to their risky ~hav ours and th~ conditions in which they live, they experience health conditions unlike their peer~ an more stable env r~nments. in addition, the majority of street youth have experienced significant physical, sexual ~nd em.ot onal abuse as younger children, directly impacting many of the choices they make around their physical and emotional health. we examined how different their health really is. . , methodl: using a retrospective analysis of the years of data gathered from yonge street mis· ~ • evergreen health centre, the top conditions of youth were examined and compared with national tren~s for similar aged youth. based on knowledge of the risk factors present in the group, rea· sons for the difference were examined. d' ~its: street youth experience more illness than other youth their age and their illnesses can bt . irect t ·~kc~ to the. conditions in which they live. long-term impacts of abus~ contribute to such signif· ~~nt t e t d~slpl air that youth may voluntarily engage in behaviours or lack of self care in the hope at t cir ve~ w perhaps come to a quicker end. concl non: although it has ion b k h th' dy clearly shows d'fi . h g ee~ no~n t at poverty negatively affects health, ~siu be used to make ; erence m t .e health of this particular marginalized population. the infonnanon can relates to th . ecommendatio.ns around public policy that affects children and youth, especially as it e r access to appropriate health care and follow up. p - (cl why do urban children · b gt . tarek hussain an adesh die: how to save our children? the traditional belief that urban child alid. a recent study (dhs d fr r~n are better off than rural children might be no longer v urban migrants are highata th om h c~untn~s i demonstrates that the child survival prospects of rural· er an t ose m their r j · · ·grants. in bangladesh, currently million ~r~ ~ gm and lower than those of urban non-idi million. health of the urban ~ p~e are hvmg m urban area and by the year , it would be so the popu at on s a key a eals that urban poor have the worse h h . concern. recent study on the urban poor rev ea t situation than the nation as a whole. this study shows that infant poster sessions v mortality among the urban poor as per thousand, which are above the rural and national level estimates. the mortality levels of the dhaka poor are well above those of the rest of the city's population but much of the difference in death rates is explained by the experience of children, especially infants. analyzing demographic surveillance data from a large zone of the city containing all sectors of the population, research showed that the one-fifth of the households with the least possessions exhibited u child mortality almost three times as high as that recorded by the rest of the population. why children die in bangladesh? because their parents are too poor to provide them with enough food, clean water and other basic needs to help them avoid infection and recover from illness. researchers believed that girls are more at risk than boys, as mothers regularly feed boys first. this reflects the different value placed on girls and boys, as well as resources which may not stretch far enough to provide for everyone. many studies show that housing conditions such as household construction materials and access to safe drinking water and hygienic toilet facilities are the most critical determinants of child survival in urban areas of developing countries. the present situation stressed on the need for renewed emphasis on maternal and child healthcare and child nutrition programs. mapping path for progress to save our children would need be done strategically. we have the policies on hand, we have the means, to change the world so that every child will survive and has the opportunity to develop himself fully as a healthy human being. we need the political will--courage and determination to make that a reality. p - (c) sherbourne health centre: innovation in healthcare for the transgendered community james read introduction: sherbourne health centre (shc), a primary health care centre located in downtown toronto, was established to address health service gaps in the local community. its mission is to reduce barriers to health by working with the people of its diverse urban communities to promote wellness and provide innovative primary health services. in addition to the local communities there are three populations of focus: the lesbian, gay, bisexual, transgendered and transexual communities (lgbtt); people who are homeless or underhoused; and newcomers to canada. shc is dedicated to providing health services in an interdisciplinary manner and its health providers include nurses, a nurse practitioner, mental health counsellors, health promoters, client-resource workers, and physicians. in january shc began offering medical care. among the challenges faced was how to provide responsive, respectful services to the trans community. providers had considerable expertise in the area of counselling and community work, but little in the area of hormone therapy -a key health service for those who want to transition from one gender to another. method: in preparing to offer community-based health care to the trans community it was clear that shc was being welcomed but also being watched with a critical eye. trans people have traditionally experienced significant barriers in accessing medical care. to respond to this challenge a working group of members of the trans community and health providers was created to develop an overall approach to care and specific protocols for hormone therapy. the group met over a one year period and their work culminated in the development of medical protocols for the provision of hormone therapy to trans individuals. results: shc is currently providing health care to registered clients who identify as trans individuals (march ) through primary care and mental health programs. in an audit of shc medical charts (january to september ) female-to-male (ftm) and male-to-female (mtf) clients were identified. less than half of the ftm group and just over two-thirds of the mtf group presented specifically for the provision of hormones. based on this chart audit and ongoing experience shc continues to update and refine these protocols to ensure delivery of quality care. conclusion: this program is an example of innovative community-based health delivery to a population who have traditionally faced barriers. shc services also include counselling, health promotion, outreach and education. p - (c) healthy cities for canadian women: a national consultation sandra kerr, kimberly walker, and gail lush on march , the national network on environment and women's health held a pan-canadian consultation to identify opportunities for health research, policy change, and action. this consultation also worked to facilitate information sharing and networking between canadian women working as urban planners, policy makers, researchers, and service workers on issues pertaining to the health of women living in canadian cities. methods: for this research project, participants included front-line service workers, policy workers, researchers, and advocates from coast to coast, including francophone women, women with disabilities, racialized women, and other marginalized groups. the following key areas were selected as topics for du.bnes i alto kading .:auk of end·sugr ieaal clileue ia singapore, accounting for more than so% of new can singapore (nkfs) to embark on a prevention program (pp) empo~r d ahc j u f dieir condition bttter, emphasizing education and disease sdf·managemen lkilla a. essennal camponenn of good glycaemic control. we sought explore the effects of a pecialijed edu.:a on pro· pun od glycacmic conuol, as indicated by, serum hba ic values budine serum hba ic values were determined before un<k-rgmng the education progr ;am, which couisted of comprehensive dietary advice, ideal weight goals, and improving lipid profiln. serum hbaic values were obtained ar , , months later to determine impact of the program. analy • wu done uling paired !·tests significant reduction in hba le levels from ro month• was observed in females, chinese race, older age group(> so yean). ohew-ibmi ~ .nwm , wai hip ratio> l),up to primary and above secondary level education and those having om urine iclt showed that increasing hbalc levels ( ) had increasing urmary protein ( .± ; . ±i ih so± ) and crearinine (s .s ± s ± ; ioi± s) levels fbg rnults showed that the management nf d abetn m the nkfs preven· tion programme is effec;rive. results also indicated har hba le leve have a linnr trend wnh unnary protein and creatinine which are imponant determinants of renal diseate tal family-focused cinical palbway promoce politivc outcollln for ua inner city canu allicy ipmai jerrnjm care llctivirits in preparation for an infanr'' dilchargr honlr, and art m endnl lo improve effi.:k'fl.:tn of c.are. lere i paucity of tttran:h, and inconsi trncy of rnulta on ht-•m!*- of f m ly·fc"-'uw d nm a: to determinr whrthrr implrmentation of family.focuted c:pt n ntnn.tt.tl unit w"n mg an inner city ;ommunity drcl't'aki leftarh of lf•y (i.osi and rromclll'i family uo•fkllon and rt. j nest for dikhargr. md odt: family-focuk"d cpi data wm coll«ted for all infant• horn btrwttn and wft"k• t"lal mi atr who wrtt . dm ed to the ntonatal unit lmgdl of -.y . n. . day'o p c o.osi ind pma . d•mr., ho.nr . t . n. . ± i. i wb, p < o.os) wett n« fiamly f.lfrt n the pre.(]' poup. ~ .fxtmon icofn for famihn wrre high. and families noctd thc:y wnr mott prepued to ah thrar t..lby "'-· thett was .a cosi uving of s , (cdn) per patient d teharpd home n the pmi-cp poap c.-pated the p"''lfoup· cortclaion· lmplrmrnr.rion of family·foanrd c:p. in a nrona . i umt tc"fyidi an nnn an com· muniry decre.ned length of'"'" mft with a high dcgrft of family uujamon, and wrre coll~nt at least % percent of the kathmandu population lives in slum like conditions with poor access to basic health services. in these disadvantaged areas, a large proportion of children do not receive treatment due to inaccessibility to medical services. in these areas, diarrhea, pneumonia, and measles, are the key determinants of infant mortality. protein energy malnutrition and vitamin a deficiency persists and communicable diseases are compounded by the emergence of diseases like hiv/aids. while the health challenges for disadvantaged populations in kathmandu are substantial, the city has also experienced various forms of innovative and effective community development health programs. for example, there are community primary health centers established by the kathmandu municipality to deliver essential health services to targeted communities. these centers not only provide equal access to health services to the people through an effective management system but also educate them hy organizing health related awareness programs. this program is considered one of the most effective urban health programs. the paper/presentation this paper will review large, innovative, and effective urhan health programs that are operating in kathmandu. most of these programs are currently run by international and national ngos a) early detection of emerging diseases in urban settings through syndromic surveillance: data pilot study kate bassil of community resources, and without adequate follow-up. in november shelter pr.oviders ~et with hospital social workers and ccac to strike a working group to address some of th~ issues by mcre.asing knowledge among hospital staff of issues surrounding homelessness, and to build a stro?g workmg relationship between both systems in hamilton. to date the hswg has conducted four w~lkmg to~ of downtown shelters for hospital staff and local politicians. recently the hswg launched its ·~ool.k t for staff working with patients who are homeless', which contains community resources and gu dehnes to help with effective discharge plans. a scpi proposal has been submitted to incre~se the capacity of the hswg to address education gaps and opportunities with both shelters and hospitals around homelessness and healthcare. the purpose of this poster presentation is to share hamilton's experience and learnings with communities who are experiencing similar issues. it will provide for intera~tion around shared experiences and a chance to network with practitioners across canada re: best practices. introduction and objectives: canadians view health as the biggest priority for the federal government, where health policies are often based on models that rely on abstract definitions of health that provide little assistance in the policy and analytical arena. the main objectives of this paper are to provide a functional definition of health, to create a didactic model for devising policies and determining forms of intervention, to aid health professionals and analysts to strategize and prioritize policy objectives via cost benefit analysis, and to prompt readers to view health in terms of capacity measures as opposed to status measures. this paper provides a different perspective on health, which can be applied to various applications of health such as strategies of aid and poverty reduction, and measuring the health of an individual/ community/country. this paper aims to discuss theoretical, conceptual, methodological, and applied implications associated with different health policies and strategies, which can be extended to urban communities. essentially, our paper touches on the following two main themes of this conference: •health status of disadvantaged populations; and •interventions to improve the health of urban communities.methodology: we initially surveyed other models on this topic, and extrapolated key aspects into our conceptual framework. we then devised a theoretical framework that parallels simple theories of physkal energy, where health is viewed in terms of personal/societal health capacities and effort components.after establishing a theoretical model, we constructed a graphical representation of our model using selfrated health status and life expectancy measures. ultimately, we formulated a new definition of health, and a rudimentary method of conducting cost benefit analysis on policy initiatives. we end the paper with an application example discussing the issues surrounding the introduction of a seniors program.results: this paper provides both a conceptual and theoretical model that outlines how one can go about conducting a cost-benefit analysis when implementing a program. it also devises a new definition and model for health barred on our concept of individual and societal capacities. by devising a definition for health that links with a conceptual and theoretical framework, strategies can be more logically constructed where the repercussions on the general population are minimized. equally important, our model also sets itself up nicely for future microsimulation modeling and analysis.implications: this research enhances one's ability to conduct community-based cost-benefit analysis, and acts as a pedagogical tool when identifying which strategies provide the best outcome. p - (a) good playgrounds are hard to find: parents' perceptions of neighbourhood parks patricia tucker, martin holmes, jennifer irwin, and jason gilliland introduction: neighbourhood opportunities, including public parks and physical activity or sports fields hav~ been. iden.tified as correlates to physical activity among youth. increasingly, physical activity among children s bemg acknowledged as a vital component of children's lives as it is a modifiable determinant of childh~d obesity. children's use of parks is mainly under the influence of parents; therefore, the purpose of this study was to assess parents' perspectives of city parks, using london ontario as a case study.m~~: this qualitative study targeted a heterogeneous sample of parents of children using local parks w thm london. parents with children using the parks were asked for minutes of their time and if willing, a s.hort interview was conducted. the interview guide asked parents for their opinion 'of city parks, particularly the one they were currently using. a sample size of parents is expected by the end of the summer.results: preliminary findings are identifying parents concern with the current jack of shade in local parks. most parents have identified this as a limitation of existing parks, and when asked what would make the parks better, parents agree that shade is vital. additionally, some parents are recognizing the v poster sessions focused discussions during the consultation: . women in _poverty . women with disability . immi· grant and racialized women . the built and _physica_l environment. . . . . r its· participants voiced the need for integration of the following issues withm the research and policy :::na; t) the intersectional nature of urban women's health i~sues wh~ch reflects the reality of women's complex lives ) the multisectional aspect of urban wo_m~n s health, ss~es, which reflects the diversity within women's lives ) the interse~roral _dynamics within _womens hves and urban health issues. these concepts span multiple sectors -mdudmg health, educat n, and economics -when leveraging community, research, and policy support, and engaging all levels of government.policy jmplicatiom: jn order to work towards health equity for women, plans for gender equity must be incorporated nationally and internationally within urban development initiatives: • reintroduce "women" and "gender" as distinct sectors for research, analysis, advocacy, and action. •integrate the multisectional, intersectional, and intersecroral aspects of women's lives within the framework of research and policy development, as well as in the development of action strategies. • develop a strategic framework to house the consultation priorities for future health research and policy development (for example, advocacy, relationship building, evidence-based policy-relevant research, priority initiatives}.note: research conducted by nnewh has been made possible through a financial contribution from health canada. the views expressed herein do not necessarily represent the views of health canada.p - (c) drugs, culture and disadvantaged populations leticia folgar and cecilia rado lntroducci n: a partir de un proyecto de reducci n de daiios en una comunidad urbana en situ· aci n de extrema vulnerahilidad surge la reflexion sobre el lugar prioritario de los elementos sociocuhurales en el acceso a los servicios de salud de diferentes colectivos urbanos. las "formas de hacer, pensar y sentir" orientan las acciones y delimitan las posibilidades que tienen los individuos de definir que algo es o no problema, asf como tambien los mecanismos de pedido de ayuda. el analisis permanenre del campo de "las culturas cotidianas" de los llamados "usuarios de drogas" aporta a la comprension de la complejidad del tema en sus escenarios reales, y colabora en los diseiios contextualizados de politicas y propuestas socio-sanitarias de intervenci n, tornandolas mas efectivas.mitodos: esta experiencia de investigaci n-acci n que utiliza el merodo emografico identifica elementos socio estructurales, patrones de consumo y profundiza en los elementos socio-simb icos que estructuran los discursos de los usuarios, caracterizandolos y diferenciandolos en tanto constitutivos de identidades socia les que condicionan la implementaci n del programas de reduccion de daiios.resultados: los resultados que presentaremos dan cuenta de las caracteristicas diferenciadas v relaciones particulares ~ntre los consumidores de drogas en este contexto espedfico. a partir de este e~tudio de caso se mtentara co ? enzar a responder preguntas que entendemos significativas a la hora de pensar intcrvcnciones a la med da de poblaciones que comparten ciertas caracteristicas socio-culturales. (cuales serian las .motivaciones para el cambio en estas comunidades?, cque elementos comunitarios nos ayudan a i:nnstnur dema~~a? • cque tenemos para aprender de las "soluciones" que ellos mismos encuenrran a los usos problemat cos? methods: our study was conducted by a team of two researchers at three different sites. the mapping consisted of filling in a chart of observable neighbourhood features such as graffiti, litter, and boarded housing, and the presence or absence of each feature was noted for each city block. qualitative observations were also recorded throughout the process. researchers analyzed the compiled quantitative and qualitative neighbourhood data and then analyzed the process of data collection itself.results: this study reveals the need for further research into the effects of physical environments on individual health and sense of well-being, and perception of investment in neighbourhoods. the process reveals that perceptions of health and safety are not easily quantified. we make specific recommendations about the mapping methodology including the importance of considering how factors such as researcher social location may impact the experience of neighbourhoods and how similar neighbourhood characteristics are experienced differently in various spaces. further, we discuss some of the practical considerations around the mapping exercise such as recording of findings, time of day, temperature, and researcher safety.conclusion: this study revealed the importance of exploring conceptions of health and well-being beyond basic physical wellness. it suggests the importance of considering one's environment and one's own perception of health, safety, and well-being in determining health. this conclusion suggests that attention needs to be paid to the connection between the workplace and the external environment it is situated in. the individual's workday experience does not start and stop at the front door of their workplace, but rather extends into the neighbourhood and environment around them. our procedural observations and recommendations will allow other researchers interested in the effect of urban environments on health to consider using this innovative methodology. introduction: responding ro protests against poor medical attention for sexually assaulted women and deplorable conviction rates for sex offenders, in the late s, the ontario government established what would become over hospital-based sexual assault care and treatment centres (sactcs) across the province. these centres, staffed around the clock with specially trained heath care providers, have become the centralized locations for the simultaneous health care treatment of and forensic evidence collection from sexually assaulted women for the purpose of facilitating positive social and legal outcomes. since the introduction of these centres, very little evaluative research has been conducted to determine the impact of this intervention. the purpose of our study was to investigate it from the perspectives of sexually assaulted women who have undergone forensic medical examinations at these centres.method: women were referred to our study by sactc coordinators across ontario. we developed an interview schedule composed of both closed and open-ended questions. twenty-two women were interviewed, face-to-face. these interviews were approximately one-to-two hours in length, and were transcribed verbatim. to date, have been analyzed for key themes.results: preliminary findings indicate that most women interviewed were canadian born ( 'yo), and ranged in age from to years. a substantial proportion self-identified as a visible minority ( 'x.). approximately half were single or never married ( %) and living with a spouse or family of origin ( %). most were either students or not employed ( %). two-thirds ( %) had completed high school and onethird ( %) was from a lower socio-economic stratum. almost two-fifths ( %) of women perceived the medical forensic examination as revictimizing citing, for example, the internal examination and having blood drawn. the other two-thirds ( %) indicated that it was an empowering experience, as it gave them a sense of control at a time when they described feeling otherwise powerless. most ( %) women stated that they had presented to a centre due to health care concerns and were very satisfied ( % ) with their experiences and interactions with staff. almost all ( %) women felt supported and understood.conclusions: this research has important implications for clinical practice and for appropriately addressing the needs of sexually assaulted women. what is apparent is that continued high-quality medical attention administered in the milieu of specialized hospital-based services is essential. at the same time, we would suggest that some forensic evidence collection procedures warrant reevaluation. the study will take an experiential, approach by chroruclmg the impa~ of the transition f m the streets to stabilization in a managed alcohol program through the techruque of narrative i~:uiry. in keeping with the shift in thinking in the mental health fie!~ ~his stu~y is based on a paradigm of recovery rather than one of pathology. the "inner views of part c pants hves as they portray their worlds, experiences and observations" will be presented (charm~z, , ~· ~)-"i?e p~ of the study is to: identify barriers to recovery. it will explore the exj?cnence of ~n~t zanon pnor to entry into the program; and following entry will: explore the meanmg ~nd defirutto~s of r~overy ~~d the impact of the new environment and highlight what supports were instrumental m movmg pan apants along the recovery paradigm.p -st (a) treating the "untreatable": the politics of public health in vancouver's inner city introdudion: this paper explores the everyday practices of therapeutic programs in the treadnent of hiv in vancouver's inner city. as anthropologists have shown elsewhere, therapeutic programs do not siinply treat physical ailments but they shape, regulate and manage social lives. in vancouver's inner city, there are few therapeutic options available for the treatment of -ilv. public health initiatives in the inner city have instead largely focused on prevention and harm reduction strategies such as needle exchange programs, safe injection sites, and safer-sex education. epidemiological reports suggest that less than a quarter of those living with hiv in the downtown eastside (dtes) are taking antiretroviral therapies raising critical questions regarding the therapeutic economy of antiretrovirals and rights to health care for the urban poor.methods: this paper is drawn from ethnographic fieldwork in vancouver's otes neighborhood focusing on therapeutic programs for hiv treatment among "hard-to-reach" populations. the research includes participant-observation at inner city health clinics specializing in the treatment of hiv; semi· structured interviews with hiv positive participants, health care professionals providing hiv treatment, and administraton working in the field of inner city public health; and, lastly, observation at public meetings and conferences surrounding hiv treatment.r.awlts: hiv prevention and treatment is a central concern in the lives of many residents living in the inner city -although it is just one of many health priorities afflicting the community. concerns about drug resistance, cost of antiretrovirals, and illicit drug use means that hiv therapy for most is characterized by the daily observation of their medicine ingestion at health clinics or pharmacies. daily observed treatment (dot) is increasingly being adopted as a strategy in the therapeutic management of "untreatable" populations. dot programs demand a particular type of subject -one who is "compliant" to the rules and regimes of public health. over emphasis on "risky practices," "chaotic lives," and "~dh~rence" preve~ts the public health system from meaningful engagement with the health of the marginalized who continue to suffer from multiple and serious health conditions and who continue to experience considerable disparities in health.~ the ~ffec~s of hiv in the inner city are compounded by poverty, laclc of safe and affordable houamg, vanous llegal underground economies increased rates of violence and outbreaks of ~~~·~ly tr~nsmitted infections, hepatitis, and tuberculosi: but this research suggests 'that public health uunauves aimed at reducing health disparities may be failing the most vulnerable and marginal of citiztl s. margaret malone ~ vi~lence that occurs in families and in intimate relationships is a significant urban, ~unity, and pu~hc health problem. it has major consequences and far-reaching effects for women, ~~--renho, you~ sen on, and families. violence also has significant effects for those who provide and ukllc w receive health care violence · · i · · . all lasses, · is a soc a act mvolvmg a senous abuse of power. it crosses : ' : ' ~ s;nden, ag~ ~ti~, cultures, sexualities, abilities, and religions. societal responseshali ra y oc:used on identificatton, crisis intervention and services for families and individuajs.promoten are only "-"--:-g to add h · ' · i in intimate relationshi with"-~"'.". ress t e issues of violence against women and vjoence lenga to consider i~ m families. in thi_s p~per, i analyze issues, propose strategies, and note c~· cannot be full -...l'-~ whork towards erad canng violence, while arguing that social justice and equity y -. ucvcu w en thett are people wh mnhod: critical social theory, an analysis that addresses culturally and ethnically diverse communities, together with a population health promotion perspective frame this analysis. social determinants of health are used to highlight the extent of the problem of violence and the social and health care costs.the ottawa charter is integrated to focus on strategies for developing personal skills, strengthening community action, creating supportive environments, devdoping healthy public policies, and re-orientating health and social services. attention is directed to approaches for working with individuals, families, groups, communities, populations, and society.ratdts: this analysis demonstrates that a comprehensive interdisciplinary, multisectoral, and multifaceted approach within an overall health promoting perspective helps to focus on the relevant issues, aitical analysis, and strategies required for action. it also illuminates a number of interacting, intersecting, and interconnecting factors related to violence. attention, which is often focused on individuals who are blamed for the problem of violence, is redirected to the expertise of non-health professionals and to community-based solutions. the challenge for health promoters working in the area of violence in families and in intimate relationships is to work to empower ourselves and the communities with whom we work to create health-promoting urban environments. social justice, equiry, and emancipatory possibilities are positioned in relation to recommendations for future community-based participatory research, pedagogical practices for health care practitioners, and policy development in relation to violence and urban health. the mid-main community health center, located in vancouver british columbia (bc), has a diverse patient base reflecting various cultures, languages, abilities, and socio-economic statuses. due to these differences, some mid-main patients experience greater digital divide barriers in accessing computers and reputable, government produced consumer health information (chi) websites, such as the bc healthguide and canadian health network. inequitable access is problematic because patient empowerment is the basis of many government produced chi websites. an internet terminal was introduced at mid-main in the summer of , as part of an action research project to attempt to bridge the digital divide and make government produced chi resources useful to a broad array of patients. multi-level interventions in co-operation with patients, with the clinic and eventually government ministries were envisioned to meet this goal. the idea of implementing multi-level interventions was adopted to counter the tendency in interactive design to implement a universal solution for the 'ideal' end-user [ ), which discounts diversity. to design and execute the interventions, various action-oriented and ethnographic methods were employed before and during the implementation of the internet terminal. upon the introduction of the internet terminal, participant observation and interviews were conducted using a motion capture software program to record a digital video and audio track of patients' internet sessions. this research provided insight into the spectrum of patients' capacities to use technology to fulfil their health information needs and become empowered. at the mid-main clinic it is noteworthy that the most significant intervention to enhance the usefulness of chi websites for patients appeared to be a human rather than a technological presence. as demonstrated in other ethnographic research of community internet access, technical support and capacity building is a significant component of empowerment ( ). the mid-main wired waiting room project indicates that medical practitioners, medical administrators, and human intermediaries remain integral to making chi websites useful to patients and their potential empowerment. ( ) over the past years the environmental yo~th alliance has been of~ering a.youth as~t. mappin~ program which trains young people in community research and evaluation. wh ~st the positive expenenc~ and relationships that have developed over this time attest to the success of this program, no evaluations has yet been undertaken to find out what works for t.he youth, what ~ould be changed, and what long term outcomes this approach offers for the youth, their local community, and urban governance. these topics will be shared and discussed to help other community disorganizing and uncials governments build better, youth-driven structures in the places they live.p - (a) the world trade center health registry: a unique resource for urban health researchers deborah walker, lorna thorpe, mark farfel, erin gregg, and robert brackbill introduction: the world trade center health registry (wfchr) was developed as a public health response to document and evaluate the long-term physical and mental health effects of the / disaster on a large, diverse population. over , people completed a wfchr enrollment baseline survey, creating the largest u.s. health registry. while studies have begun to characterize / bealth impacts, questions on long-term impacts remain that require additional studies involving carefully selected populations, long-term follow-up and appropriate physical exams and laboratory tests. wtchr provides an exposed population directory valuable for such studies with features that make ita unique resource: (a) a large diverse population of residents, school children/staff, people in lower man· hattan on / including occupants of damaged/destroyed buildings, and rescue/recovery/cleanup work· ers; (b) consent by % of enrollees to receive information about / -related health studies; (c) represenration of many groups not well-studied by other researchers; (c) email addresses of % of enrollees; (d) % of enrollees recruited from lists with denominator estimates; and (e) available com· parison data for nyc residents. wfchr strives to maintain up-to-date contact information for all enrollees, an interested pool of potential study participants. follow-up surveys are planned.methods: to promote the wtchr as a public health resource, guidelines for external researcher.; were developed and posted on (www.wtcregistry.org) which include a short application form, a twopage proposal and documentation of irb approval. proposals are limited to medical, public health, or other scientific research. researchers can request de-identified baseline data or have dohmh send information about their studies to selected wfchr enrollees via mail or email. applications are scored by the wtchr review committee, comprised of representatives from dohmh, the agency for toxic subst~nces and disease registry, and wtchr's scientific, community and labor advisory committees. a data file users manual will be available in early fall .~suits: three external applications have been approved in , including one &om a non-u.s. ~esearcher, all requesting information to be sent to selected wtchr enrollees. the one completed mail· mg~~ wtchr enrollee~ (o , wfc tower evacuees) generated a positive survey response rate. three additional researchers mtend to submit applications in . wfchr encourages collaborations between researchers and labor and community leaders.conclusion: studies involving wtchr enrollees will provide vital information about the long· term health consequences of / . wtchr-related research can inform communities, researcher.;, policy makers, health care providers and public health officials examining and reacting to and other disasters. t .,. dp'"f'osed: thi is presentation will discuss the findings of attitudes toward the repeat male client iden· ie as su e a and substance us'n p · · · · i · 'd . . - g. articipants will learn about some identified effective strategies or service prov ers to assist this group of i · f men are oft · d bl men. n emergency care settings, studies show that this group en viewe as pro emaric patient d i r for mental health p bl h h an are more ikely to be discharged without an assessmen !) ea rofr ems t. an or er, more cooperative patients (forster and wu · hickey er al., · r y resu ts om this study suggest th · · ' ' l · d tel' mining how best to h . d at negative amtudes towards patients, difficu nes e · as well pathways l_e_ p patientsblan ~ck of conrinuity of care influence pathways to mental health care. • uc\:ome pro emat c when p ti k · che system. m a ems present repeatedly and become "get stuc id methods: semi-structured intervie d . · (n= ), ed nurses (n= ) other ed ;s were con ucted with male ed patients (n= ), ed phys oans ' sta (n= ) and family physicians (n= ). patients also completed a poster sessions v diagnostic interview. interviews were tape-recorded, transcribed verbatim and managed using n . transcripts were coded using an iterative process and memos prepared capture emergent themes. ethics approval was obtained and all participants signed a detailed informed consent form.introduction: urban settings are particularly susceptible to the emergence and rapid spread of nt•w or rare diseases. the emergence of infectious diseases such as sars and increasing concerns over the next influenza pandemic has heightened interest in developing and using a surveillance systt·m which detects emerging public health problems early. syndromic surveillance systems, which use data b, scd on symptoms rather than disease, offer substantial potential for this by providing near-real-rime data which are linked to an automated warning system. in toronto, we are piloting syndromic data from the · emergency medical services (ems) database to examine how this information can be used on an ongoing basis for the early detection of syndromes including heat-related illness (hri), and influenza-like-illness (ill). this presentation will provide an outline of the planned desi_gn of this system and proposed evaluation. for one year, call codes which reflect heat-related illness or influenza-like-illness will be selected and searched for daily using software with a multifactorial algorithm. calls will he stratified by call code, extracted from the -ems database and transferred electronically to toronto public health. the data will be analyzed for clusters and aberrations from the expected with the realtime outbreak and disease surveillance (rods) system, a computer-based public health tool for the early detection of disease outbreaks. this -ems surveillance system will be assessed in terms of its specificity and sensitivity through comparisons with the well-established tracking systems already in place for hr! and ill. others sources of data including paramedic ambulance call reports of signs and . this study will introduce complementary data sources t~ the ed ch e~ complamt an~ o~~rthe-counter pharmacy sales syndromic surveillance data currently bemg evaluated m ~ther ontar~o cltles. . syndromic surveillance is a unique approach to proactive(~ dete~tmg early c.hangesm the health status of urban communities. the proposed study aims to provide evidence of differential effectiveness through investigating the use of -ems call data as a source of syndromic surveillance information for hr! and ili in toronto. introduction: there is strong evidence that primary care interventions, including screening, brief advi<:e, treatment referral and pharmacotherapy are effective in reducing morbidity and mortality caused by substance abuse. yet physicians are poor at intervening with substance users, in part because of lack of time, training and support. this study examines the hypothesis that shared care in addictions will result in decreased substance use and improved health status of patients, as well as increased use of primary care interventions by primary care practitioners (pcps). methods: the addiction medicine service (ams) at st. joseph's health centre's family medicine department is in the process of being transformed from its current structure as a traditional consult service into a shared care model called addiction shared care (asc). the program will have three components: education, office systems and clinical shared care. as opposed to a traditional consult service, the patient will be booked with both a primary care liaison worker (pcl) and addictions physician. patients referred from community physicians, the emergency department and inpatient medical and psychiatric wards will be recruited for the study as well as pcps from the surrounding community. the target sample size is - physicians and a similar number of patients. after initial consult, patient will be recruited into the study with their consent. the shared-case model underlines the interaction and collaboration with the patient's main pcp. asc will provide them with telephone consults, advice, support and re-assessment for their patients, as well as educational sessions and materials such as newsletters and informational kits.results: the impact of this transition on our patient care and on pcp's satisfaction with the asc model is currently being evaluated through a grant provided by the ministry of health & long term care. a retrospective chart review will be conducted using information on the patient's substance use, er/clinic visits, and their health/mood status. pcp satisfaction with the program will be measured through surveys and focus groups. our cost-effectiveness analysis will calculate the overall cost of the program per patient..conclusion: this low-cost service holds promise to serve as an optimal model and strategy to improve outcomes and reduce health care utilization in addict patients. the inner city public health project introduction the inner city public health project (icphp) was desi.gned to explore new an~ innovative ways to reach marginalized inner city populations that par-t c pate m high health-nsk beha~ ors. much of this population struggles with poverty, addictions, mental illness and homelessness, creatmg barriers to accessing health services and receiving follow-up. this pro ect was de~igned to evaluat~ .~e success of offering clinics in the community for testing and followup of communicable diseases uuhzmg an aboriginal outreach worker to build relationships with individuals and agencies. v n(demographics~ history ~f testi~g ~nd immunization and participation in various health-risk behaviors), records of tesnng and mmumzat ons, and mterviews with partner agency and project staff after one year.. results: t~e chr ~as i~strumental in building relationships with individuals and partner agencies ' .° the c~mmun_ ~ re_sultmg m req~ests for on-site outreach clinics from many of the agencies. the increase m parnc pat n, the chr mvolvement in the community, and the positive feedback from the agen? staff de~onstrated that.the project was successfully creating partnerships and becoming increasingly integrated m the community. data collected from clients at the initial visit indicated that the project was reaching its target populations and highlighted the unique health needs of clients, the large unmet need for health services and the barriers that exist to accessing those services. ~usion: the outreach clinics were successful at providing services to target populations of high health-nsk groups and had great support from the community agencies. the role of the chr was critical to the success of the project and proved the value of this category of health care worker in an urban aboriginal population. the unmet health needs of this disadvantaged population support the need for more dedicated resources with an emphasis on reducing access barriers. building a caring community old strathcona's whyte avenue, a district in edmonton, brought concern about increases in the population of panhandlers, street people and homeless persons to the attention of all levels of government. the issue was not only the problems of homelessness and related issues, but feelings of insecurity and disempowerment by the neighbourhood residents and businesses. their concerns were acknowledged, and civic support was offered, but it was up to the community itself to solve the problem. within a year of those meetings, an adult outreach worker program was created. the outreach worker, meets people in their own environments, including river valley camps. she provides wrap-around services rooted in harm reduction and health promotion principles. her relationship-based practice establishes the trust for helping clients with appropriate housing, physical and/or mental health issues, who have little or no income and family support to transition from homelessness. the program is an excellent example of collaboration that has been established with the businesses, community residents, community associations, churches, municiple services, and inner-city agencies such as boyle street community services. statistics are tracked using the canadian outcomes research institute homes database, and feedback from participants, including people who are street involved. this includes an annual general meeting for community and people who are homeless. the program's holistic approach to serving the homeless population has been integral, both in creating community awareness and equipping residents and businesses to effectively interact with people who are homeless. through this community development work, the outreach worker engages old strathcona in meeting the financial and material needs of the marginalized community. the success of this program has been surprising -the fact is that homeless people's lives are being changed; one person at a time and the community has been changed in how they view and treat those without homes. over two years, the program has successfully connected with approximately seventy-five individuals who call old strathcona home, but are homeless. thirty-six individuals are now in homes, while numerous others have been assisted in obtaining a healthier and safer lifestyles by becoming connected with other social/health agencies. the program highlights the roots of homelessness, barriers to change and requirements for success. it has been a thriving program and a model that works by showing how a caring community has rallied together to achieve prosperous outcomes. the spn has created models of tb service delivery to be used m part~ers~ p with phannaceunca compa-. · · -. t' ns cooperatives and health maintenance orgamzanons (hmos). for example, the mes, c v c orgamza , . · b tb d' · spn has established a system with pharmaceutical companies that help patients to uy me cmes at a special discounted rate. this scheme also allows patients to get a free one-_month's worth of~ dru_g supply if they purchase the first months of their regimen. the sy_s~e~s were ~es gned to be cm~pattble with existing policies for recording and documentation of the ph hppme national tuberculosis program (ntp). aside from that, stakeholders were also encouraged to be dots-enabled through the use of m~nual~ and on-line training courses. the spn initiative offers an alternative in easing the burden of tb sc:rv ce delivery from rhe public sector through the harnessing of existing private-sector (dsos). the learnmgs from the spn experience would benefit groups from other locales that _work no~ only on ~ but other health concerns as well. the spn experience showcases how well-coordinated private sector involvements help promote social justice in health delivery in urban communities.p - (c) young people in control; doing it safe. the safe sex comedy juan walter and pepijn v. empelen introduction: high prevalence of chlamydia and gonorrhoea have been reported among migrants youth in amsterdam, originating from the dutch antilles, suriname and sub-sahara africa. in addition, these groups also have high rates of teenage-pregnancy (stuart, ) and abortions (rademakers ), indicating unsafe sexual behaviour of these young people. young people (aged - ) from the so· called urban scene (young trendsetters in r&b/hip hop music and lifestyle) in amsterdam have been approached by the municipal health service (mhs) to collaborate on a safe sex project. their input was to use comedy as vehicle to get the message a cross. for the mhs this collaboration was a valuable opportunity to reach a hard-to-reach group.mdhods: first we conducted a need assessment by means of a online survey to assess basic knowledge and to similtaneously examine issues of interest concerning sex, sexuality, safer sex and the opposite sex. second, a small literature study was conducted about elements and essential conditions for succesful entertainment & education (e&e) (bouman ), with as most important condition to ensure that the message is realistic (buckingham & bragg, ) . third a program plan was developed aiming at enhancing the stl/hiv and sexuality knowledge of the young people and addressing communication and educational skills, by means of drama. subsequently a safe sex comedy show was developed, with as main topics: being in love, sexuality, empowerment, stigma, sti, hivand safer sex. the messages where carried by a mix of video presentation, stand up comedy, spoken word, rap and dance.results: there have been two safe sex comedy shows. the attendance was good; the group was divers' with an age range between and year, with the majority being younger than year. more women than men attended the show. the story lines were considered realistic and most of the audients recognised the situations displayed. eighty percent of the audients found the show entertaining and % found it edm:arional. from this %, one third considers the information as new. almost all respondents pointed our that they would promote this show to their friends.con.clusion: the s.h<_>w reached the hard-to-reach group of young people out of the urban scene and was cons d_ered entert~mmg, educational and realistic. in addition, the program was able in addressing important issues, and impacted on the percieved personal risk of acquiring an sti when not using condoms, as well as on basic knowledge about stl's. introduction: modernity has contributed mightily to the marginality of adults who live with mental illnesses and the subsequent denial of opportunities to them. limited access to social, vocational, educational, and residential opportunities exacerbates their disenfranchisement, strengthening the stigma that has been associated with mental illness in western society, and resulting in the denial of their basic human rights and their exclusion from active participation in civil society. the clubhouse approach tn recovery has led to the reduction of both marginality and stigma in every locale in which it has been implemented judiciously. its elucidation via the prism of social justice principles will lead to a deeper appreciation of its efficacy and relevance to an array of settings. methods: a review of the literature on social justice and mental health was conducted to determine core principles and relationships between the concepts. in particular, fondacaro and weinberg's ( ) conceptualization of social justice in community psychology suggests the desirability of the clubhouse approach in community mental health practice. a review of clubhouse philosophy and practice has led to the inescapable conclusion that there is a strong connection between clubhouse philosophy-which represents a unique approach co recovery--and social justice principles. placing this highly effective model of community mental health practice within the context of these principles is long overdue. via textual analysis, we will glean the principles of social justice inherent in the rich trove of clubhouse literature, particularly the international standards of clubhouse development.results: fondacarao and weinberg highlight three primary social justice themes within their community psychology framework: prevention and health promotion; empowerment, and a critical pnsp<"<·tive. utilizing the prescriptive principles that inform every detail of clubhouse development and th<" movement toward recovery for individuals at a fully-realized clubhouse, this presentation asserts that both clubhouse philosophy and practice embody these social justice themes, promote human rights, and empower clubhouse members, individuals who live with mental illnesses, to achieve a level of wdl-heing and productivity previously unimagined.conclusion: a social justice framework is critical to and enhances an understanding of the clubhouse model. this model creates inclusive communities that lead to opportunities for full partic pil!ion civil society of a previously marginalized group. the implication is that clubhouses that an· based on the international standards for clubhouse programs offer an effective intervention strategy to guarantee the human rights of a sizable, worthy, and earnest group of citizens. to a drastic increase in school enrollment from . million in to . million in .s. however, while gross enrollment rates increased to °/., in the whole country after the introduction of fpe, it remained conspicuously low at % in the capital city, nairobi. nairobi city's enrollment rate is lower .than thatof all regions in the country except the nomadic north-eastern province. !h.e.d sadvantage of children bas_ed in the capital city was also noted in uganda after the introduction of fpe m the late s_-many_ education experts in kenya attribute the city's poor performance to the high propornon of children hvmg m slums, which are grossly underserved as far as social services are concerned. this paper ~xammes the impact of fpe and explores reasons for poor enrollment in informal settlements m na rob city. methods: the study utilizes quantitative and qualitative schooling data from the longitudinal health and demographic study being implemented by the african population and health research center in two informal settlements in nairobi. descriptive statistics are used to depict trends in enrollment rates for children aged - years in slum settlements for the period - . results: the results show that school enrollment has surprisingly steadily declined for children aged - while it increased marginally for those aged - . the number of new enrollments (among those aged years) did not change much between and while it declined consistently among those aged - since . these results show that the underlying reasons for poor school attendance in poverty-stricken populations go far beyond the lack of school fees. indeed, the results show that lack of finances (for uniform, transportation, and scholastic materials) has continued to be a key barrier to schooling for many children in slums. furthermore, slum children have not benefited from fpe because they mostly attend informal schools since they do not have access to government schools where the policy is being implemented.conclusion: the results show the need for equity considerations in the design and implementation of the fpe program in kenya. without paying particular attention to the schooling needs of the urban poor children, the millennium development goal aimed at achieving universal primary education will remain but a pipe dream for the rapidly increasing number of children living in poor urban neighborhoods.ps- (c) programing for hiv/aids in the urban workplace: issues and insights joseph kamoga hiv/aids has had a major effect on the workforce. according to !lo million persons who are engaged in some form of production are affectefd by hiv/aids. the working class mises out on programs that take place in communities, yet in a number of jobs, there are high risks to hiv infection. working persons sopend much of their active life time in workplaces and that is where they start getting involved in risky behaviour putting entire families at risk. and when they are infected with hiv, working people face high levels of seclusion, stigmatisation and some miss out on benefits especially in countries where there are no strong workplace programs. adressing hiv/aids in the workplace is key for sucessfull responses. this paper presents a case for workplace programing; the needs, issues and recommendations especially for urban places in developing countries where the private sector workers face major challenges. key: cord- -fzjbdsg authors: pellegrino, edmund d.; thomasma, david c. title: the good of patients and the good of society: striking a moral balance date: journal: public health policy and ethics doi: . / - - - _ sha: doc_id: cord_uid: fzjbdsg the relationship between the good of individual patients and the special good is examined when they are in conflict. the proposition is advanced that the ethical resolution of such conflicts requires an ethic of social medicine comparable to the existing ethic of clinical medicine. comparing and contrasting the obligations clinicians incur under both aspects of the ethics of medicine is propadeutic to any ordering of priorities between them. the suggested partition of obligations between patient good and the common good is applicable beyond medicine to the other health professions. in previous works we have held that an authentic ethic of clinical medicine must have its roots in a philosophy of medicine in which the good of the patient determines the obligations and virtues of the health professional. in this essay we extend the same line of reasoning to the medicine of society. we contend that an authentic ethic of social medicine must have its roots in a philosophy of society in which the common good determines the obligations and virtues of the health professional. we deem a parallel development of the ethics of individual and social medical ethics to be a requisite for any ordering of priorities between, and among, them when they come into conflict in decision making. though the ethics of medicine has traditionally centered on the obligations of physicians to individual patients, there has always been a need to recognize the ethical issues arising from the fact that medicine is always practiced within a social context. the factual basis for the recognition of this fact was late in coming in the history of medicine. it is, however, especially pressing today for several reasons. physicians and nurses today practice within organizations, institutions, and systems; they are members of interprofessional health care teams and professional associations; access, availability, and distribution of health care has become a question of justice, and fairness; the economic, societal, and political impact of medical decisions have ethical significance, as does the conduct of health care organizations; potential be included under the same rubric. the ethics of the medicine of society, to be properly delineated, should be located within a broader context of a philosophy of society. we prefer this term to a social philosophy, which is currently used too diffusely for our purposes. by a philosophy of society we mean a study of the nature, being, and existence of humans living and working together. it is studies of the organisms humans generate to fulfill their essential nature as social and political beings, beings who need society and social instruments to attain their good as humans. the locus of study of a philosophy of society may be the family, community, state, nation, profession, or even the global community. a philosophy of society begins with the question-"what is society, what is its nature, to what does it tend, and what is its telos or end?" the telos of society is ultimately the good of the persons who constitute that society, the good essential to their fulfillment of their potential as humans. this is a good that cannot be fully achieved by humans living isolated from each other. within such a philosophy of medicine the medicine of society has a specific function. that function is the use of medical knowledge to cultivate the health of the social organism by treating illness and preventing disease in its members since a healthy society cannot thrive without healthy citizens. an ethic of the medicine of society is directed to the good of the social organism, to the common good, the good shared by all and owed to all. to be sure, the ethic of the medicine of society will be shaped by the philosophy of society within which it exists. in a libertarian society conceived as a voluntary association of free individuals (gesellschaft), the ethics of social medicine will be constructed in terms of free markets, individual choice, and little or no government involvement. in a communitarian society (gemeinschaft) in which the individual is defined by the group, the ethic would emphasize just distribution of goods, controlled markets, limitations on individual freedoms, and government involvement. in each case, the well functioning of society and its members is sought. the philosophy of society that provides the framework for the ethic of the medicine of society that we espouse lies between these extremes. it is rooted in the social philosophies of aristotle and thomas aquinas. this social philosophy holds to a reciprocal view of the relations of the good society and the good person. neither has sovereignty over the other. it avoids totalitarianism, which exalts the common good above the individual as it avoids anarchism of exalting the good of the individual over the good of the whole. a truly dynamic philosophy of society recognizes the necessity of a continuously negotiated struggle to balance individual and common good. within this dynamic relationship of individual and common good, health and health care can be seen as societal goods because health is a good of human life, an essential component of human flourishing. in his politics aristotle speaks of the special care that should be taken of the inhabitants of a society. in establishing a city he lists health as a first necessity. his reference here is not just to providing individual care but to the public health as a common good. aquinas, likewise, takes the function of the state to be the promotion of the common good which he specifies in terms of preservation of peace, promotion of moral well being, and ensuring a sufficient supply of the material necessities of life. according to aquinas the state, like society, is necessary for the development of human potentialities and its function is to provide the conditions for the good life. clearly, the conception of society set out by aristotle and aquinas is incompatible with the extremes of a libertarian, laissez faire conception of society or, on the other hand, with a marxist, all-consuming state-controlled economy. for both aquinas and aristotle the good for humans and the good for society are not determined by social preference. rather, the good is defined by natural law that sees societies and life in communities as essential for humans if humans are to develop their full potentialities as human beings. neither aristotle nor aquinas could imagine the enormous capabilities of today's medicine, which when properly used, can enhance social and individual flourishing. but it is not unreasonable to assume that they would regard health and medical care as among the responsibilities of a good society toward its citizens, but not their highest good. health would be at the least a material and instrumental good for both the individual and the society. at best it would be a material necessity that the state should assure for all. health care could not be a privilege to be enjoyed only by those fortunate enough to afford it. it could not be left to the fortuitous interplay of commerce, the competitive marketplace, and the medical entrepreneur. in a good society health care is a common good as well as an individual good. herein lies the tension that is of such growing concern today when health care resources are generally regarded as limited relative to the potential benefit they offer if used optimally. that tension brings commutative and distributive justice into conflict. traditionally the physician has felt ethically bound to commutative justice, i.e. the obligation to be faithful to a promise of trust that he or she will act primarily in his or her patients' best interests. but, in recent years, increasing pressure from governments, health plan administrators, ethicists, and the public have tended to add distributive justice, i.e. the preservation and conservation of social resources to the physician's ethical obligation. some ethicists and policy makers suggest that a "new" medical ethic is neces-sary, one in which the physician's ethical concern should be transferred from the primacy of the patient to the primacy of the society. a further extension of this trend is to move the patient's trust relationship away from doctor to the institution. the health "system," not the physician, in effect becomes the patient's healer, advocate, and guarantor of safety. our line of argument rejects these calls for a "new" ethic of medicine. it also resists trends to establish societal duties as primary for clinicians. we acknowledge that medicine as a practice, and physicians and health professionals within that practice, do have social obligations. nonetheless, these obligations can, and must, be served without sacrifice of the trust relationship inherent in the clinical encounter. we therefore distinguish the obligations of the clinician that are dictated by the ends of clinical medicine and those of the public health physician or nurse dictated by the end of the common good. the clinical relationship centers on a vulnerable, anxious, dependent, often suffering individual person. by offering to help, the clinician "professes" to possess medical knowledge that she will use for the patient's good. the clinician serves the common good by her dedication to the good of individual patients. clinicians, physicians, and nurses are de facto advocates for the good of their patients. for public health physicians and nurses the relationship is with the whole society. the end or purpose of the relationship is the good of humans as a collectivity, the common good. public health physicians act for the good of all to the extent that medical knowledge can serve that good. they are the de facto advocates for the common good. their "patient" is society and its ills. they serve the good of society's individual members secondarily by assuring a healthy community in which the individual can flourish. clinical medicine and public health medicine having different immediate ends cannot be conflated. they remain in a dynamic relationship with each other since the end of each is essential for human well-being. this is consistent with the social philosophy we have espoused above. clinical medicine and the medicine of society, however, can in exercising their obligations, each within its own domain, conflict with each other. that conflict may be generated on either side of the relationship. in the one case the undeviating commitment of the clinician on the good of his patient can conflict with societal attempts to conserve resources, impose standards of clinical care, or provide tort relief for medical error. by the same token, the efforts of those who practice the medicine of society may conflict with the pursuit of patient good by over-regulation of bedside decisions, limiting hospital access, or providing inadequate mental health care for the poor, or overburdening clinicians with paperwork that takes time from care of patients. on the social philosophy we have espoused practitioners of clinical medicine and of the medicine of society both serve a human good, each from its own perspective. when they do conflict in fact, there is need for some ethical priority setting. such a setting of priorities requires a framework in which the ethical foundation for both clinical and social medicine can be interrelated. much of the history and literature of ethics and bioethics consists of elaborations of the ethics of clinical medicine and individual patient care. similar frameworks for the ethics of the medicine of society are still in a state of development. in the next section of this essay we offer a philosophy and ethic of the medicine of society based in a definition of the ends of social medicine. first, a word about ends is necessary because we ground individual and social ethics of medicine in the ends that distinguish them. today's confusion about the ends of medicine and the need for their redefinition lies in the erosion of the classical-medieval notion of ends, their relation to the good, and the relation between the idea of the good and ethics. the good is the end or telos of human activity, and the end is that for which a thing exists, that which an act is designed to bring about. ends are rooted in the nature of things themselves. they answer the question "what for?" we do not impute ends to things; things are not good because we desire them. we desire them because they are good. we may put things, like medicine, to certain goals and purposes, but whether these are good or bad uses depends upon whether they fulfill the ends for which medicine exists and that define it qua medicine. aristotle and aquinas, whose line of reasoning we follow here, were concerned chiefly with the larger conception of the good for humans as the end of human activity. both structured their moral philosophies on the good as the end of human life. that end in its ultimate sense was, for aristotle, a life consistent with the natural virtues, which led to happiness. for aquinas, it was a life lived in accord with the natural and spiritual virtues that led to the beatific vision and fulfilment of the spiritual nature of humans. both aristotle and aquinas used medicine as an example of a human activity with a definable end and good, a lesser good, of course, than the ultimate good of human beings as such. they defined the final end of medicine as health, toward which the activity of medicine tended, that which made it what it was, and distinguished it from other human activities. yet health was for them a subsidiary end, oriented toward the life of an individual in society an enhancing as many of that individual's powers of fulfillment as possible. thus, in determining the ends and good of human life, and in the realm of lesser good in everyday life, ends and the good are intimately related. today, discussion of ends has been replaced by discussion of values and choices. the rights to choose and to value have become the warp and woof of bioethics, rather than a search for the good of individuals and society. iris murdoch put it this way: "the philosopher is no longer to speak of something real and transcendent but to analyze the familiar activity of endowing things with value." the shift from consideration of ends to consideration of "value" choices lies at the root of confusion about social medicine and its philosophy as well. on the modernist view, social medicine should be aimed at whatever people value or choose among the sentiments of liberal society. the continuing debate about prescribing growth hormones for healthy, but smaller than average children, is an example of how social mores about size and its importance directly influence clinical medicine and public policy. the debate about the proper use of this and other capabilities of modern medicine, like so many others, will be interminable if it is not anchored somehow in a notion of the good for humans as it relates to the powers of modern biotechnology. the ongoing debates about "enhancement" versus "treatment" are an example of our society's confusion about the proper ends and uses of medical knowledge. in one of our books we defined four levels in the complex notion of the good of the patient in the clinical encounter. in an analagous way we can develop a quadripartite notion of the ends and good of social medicine: ) the first and lowest level is the medical good of society, that can result from the application of medical knowledge to cultivate the health of society as an organism; ) the second level is the good of society as society perceives it; ) the third level is the ontological good of society qua society; and ) the last level is the spiritual and non-historical good, that which fosters the flourishing of the human spirit. taken together, these four levels of social good anchor the ends of medical knowledge when it is applied in a social context. the medical good of society relates most closely to the techné of medicine, nursing, dentistry, etc. it is the good determined as indicated by the current state of medical knowledge, by what is subsumed under the rubric of the standard of care. the good of social medicine is aimed at the medical good of the social organism as a whole: prevention of disease and disability, assuring a healthy environment, containing and ending epidemics, public education in matters of health, advising appropriate agencies on such matters as occupation health, safety of food and water supplies, occupational health and safety, responding to natural or man-made catastrophe, etc. in short, all those domains subsumed under the title of public health and social medicine are dedicated to the medical good of the social organism. on this view, then, the medical goods of society differ from the medical goods of clinical medicine only in scope, not in kind. the training of the health professionals at this level focuses especially upon dealing with the larger forces operating in groups and communities. the associated moral problems of medicine at this level center on the difficulties involved in adjudicating the proper balance between providing these goods for the sake of the entire community, based upon its needs, and the other levels of social goods and services beyond health, such as education, housing, etc. even in nations that provide access to health care for all, elements of distributive justice must be considered so that the health budget does not compromise the resources available for other social goods not related to medicine. in clinical medicine the medical good can actually become harmful. if it is provided solely on the grounds of clinical or physiological effectiveness, it may result in harm, overtreatment, etc. so too, the medical good or society cannot be allowed to overmaster other social goods that may matter more to communities. a good example was provided in the public discussions leading to the oregon "experiment," when senior citizens covered by medicaid chose to put resources into home visits by health professionals to check medications rather than into access to emergency room care. this was their perception of their good (our second level). yet, were they to experience a medical emergency, like a stroke, heart attack, hemorrhage, etc., emergency care might well be their first choice. in this case, the good defined by purely medical criteria conflicted with society's perception of its medical good. it is arguable whether or not this was socially the best choice. yet in the allocation of resources, the final decision rests with society and not the physician. we would argue that in this case the medical good of society was compromised. robert veatch, however, might argue that whatever society decides is a good, should be provided by health professionals. social consensus, he contends, determines the good, not the physician. we think this is an error of delegation. health professionals are trained to determine the medical good of individuals and society. society may reject their choice but this it does at its own peril, just as the patient does who rejects effective antibiotic treatment from an infection. the task of the health professional is to provide information necessary for a rational policy choice. society's perception of its own good may differ for many reasons, especially in the allocation of its resources. while the final decision is a social one, the health professional must retain a personal and professional integrity as a critic of the scientific and technical content of that decision. society is, thus, not the final arbiter of the medical (scientifically indicated) good of society, just as a jehovah's witness patient does not determine the clinical medical good of receiving a blood transfusion. she deems the medical good to be a spiritual harm. however, the religious patient accepts or rejects the scientifically-based medical good for the sake of her perception of the good at a higher level. similarly, society may balance provisions of social medical good based upon higher values. for example, in the current world epidemic of corona virus infection (sars), rights of privacy are seen by some as endangered by certain quarantine regulations. thus, like individual patients, society may not perceive the medical good, as defined by health professionals, as "good." "society" may prefer other good things it perceives as preferable to the health care -economic growth, the ability to compete economically with other nations, military service, public safety, liberty in personal choice and risk taking, education, housing, recreation, etc. seat belts, car seats for infants, safe driving, restrictions on hand guns, abstinence from tobacco and addictive substances, etc., have been widely promoted by the medical profession as good for the social organism as a whole. they have often been neglected in favor of freedom of choice, economics, or lifestyle preferences. we have just mentioned and given examples of how patients and societies may perceive other goods to be more important than the medical good being suggested or recommended to them, and how this dynamic is also part of the social dynamic in health care. the social medical good serves the many complex facets of what individual societies may perceive as their own good. at this level a social philosophy of medicine would be concerned with political choices, preferences, and concerns that may distinguish one society from another. here society determines the balances it wishes to provide its citizens, and its political processes should facilitate to public dialogue and decisions about that balance. although medicine is a universal discipline and is practiced world-wide, it is not the duty of the physician to make these social choices except as he or she functions as a citizen, an invited consultant, or as an agent of the government in carrying out its social policies about health care. since each country and society is unique in its demographics and customs, they will balance the social medical good in different ways. these choices are determined by interactions between and among citizens, their specific economic and natural environments, and their cultural and religious histories. just as individual patients might decide how a specific treatment fits into her life-plans, so too, society decides what elements of health care fit into its own plans for human development. all social good must ultimately be related to the general good for human societies. humans are social animals and need a healthy society to sustain their flourishing; similarly, a healthy society is not possible without healthy citizens. clinical medicine and social medicine intersect in preserving the dignity of the human person. to do so, each must respect human rationality and freedom in decision-making. to serve the good for society as society, health professionals must foster the inherent value of the person independent of wealth, prestige, education, and social position. in clinical medicine the patient is a fellow human being alongside the health professional. they are joined together at this level by bonds of solidarity, trust, and mutual respect. at the societal level, doctor and patient are united by the same bonds with the whole of society and ultimately with all humanity. it is at this third level that many of the familiar principles and concerns of biomedical ethics are philosophically rooted, such as respect for autonomy, beneficence, non-maleficence, and justice. these are principles which a society, concerned with preservation of the dignity of its citizens as humans, must assure. at this level, the qualities of justice are to be observed with respect to health care. justice here is understood as the equality of treatment of all human beings who are equally vulnerable with respect to illness and death. one of the axioms of moral medicine is that each individual person must be treated as a class instance of the human race. this axiom is applicable to both clinical and social medicine. denial of care to the poor or disvaluing the lives of handicapped persons, for example, violates their inherent dignity as human persons, not just their "share" of the health care marketplace. intentionally putting some members of society at risk presumably to help others, without their consent, as was done in radiation experiments in our country, is a violation of fundamental human rights. the newly-developing efforts in bioethics to reintroduce global, environmental, and international human rights concerns would also be placed at this level. thus, the first and second level, i.e. social medical good and perceived goods, must be related to the third, the good for human beings as human beings. at this level, both clinical medicine and social medicine intersect in the good end of preserving the dignity of the human person, by respecting his and her rationality and decision-making. they recognize, especially, the inherent value of the person as independent of wealth, prestige, education, social position, and other characteristics that so often serve to separate rather than unite human beings. as in clinical medicine, the patient is a fellow human being with the health professional. they are bound together at this third level of good by bonds of solidarity and mutual respect. in a more classical sense, the prima facie principles of contemporary bioethics and the universal rights of humans, as enunciated by the united nations, come together in the natural law. the good of society and the good of each person in that society are mutually re-enforcing. they link the good of man (and woman) with the good of society in a dynamic tension. they underlie the characters of the good society and the good person. at this level, justice requires that health care be treated as an obligation of a good society -as a moral obligation of a good society to its citizens. this is because health care is a universal human need -a need all humans experience if they are to lead fulfilling lives and be cared for when they are ill. each citizen, thus, has a claim on his fellows -not to health, but to care when he or she is ill. health care is in essence an obligation a good society owes its citizens in justice. the fourth and highest level of good for clinical encounters, between patient and health professional, is the spiritual good of the patient, as we have noted. this is the good of the patient as a spiritual being who transcends ordinary material concerns. analogously, there is a spiritual dimension in the community itself, though it is more difficult to define. this dimension is always present, but it becomes more visible in times of crisis, for example, after a terrorist attack like that of september , . for some thinkers, the social ethic of medicine stands or falls on the adequacy of its articulation with deeply embedded spiritual values inherent in the very notion of the community. for loewy, the spiritual dimension is compassion that must emerge from the fact of suffering of all creatures; for welie, it is the intersubjectivity of suffering and shared values that grounds the clinical encounter; for jensen, it is the brotherhood of a common culture and concern; and for still others, it is the solidarity with the sick and the potential for human development. for christians, generally it is the solidarity of all humans as children of the same creator. the spiritual good of a society encompasses the transcendent principles of the culture. it gives ultimate meaning to human lives. it is that for which humans will make the greatest sacrifices of other good things to preserve. from the perspective of the structures of human existence, the spiritual destiny of the human being is the highest and ultimate good. for many cultures this will mean the religious beliefs of their citizens. for example, despite the physical need to examine a pregnant woman in clinical medicine, a different method of examination might be required in some islamic societies where privacy is a religious value. or, even though a respirator may be appropriate for a patient suffering from severe trauma, for the navajo american indian, this may violate a profound religious belief about god and nature and be proscribed. this is not to assert that all cultural practices should be tolerated simply because there exists a religious tradition to support them. at the very least, however, efforts must be made to understand and if possible accommodate the lower order of medical good to the higher order of the spiritual good of individuals and societies. thus far we have argued that the public aspects of medicine, and the social ethics of medicine that results, may be interpreted within the same framework as that of the clinical encounter. by keeping the anchor in the clinical encounter as we have in this chapter, we tried to avoid the contemporary tendency to over-medicalize all of society's problems. physicians need not be, indeed, should not be social engineers, as the nazi experience so clearly taught us. for example, domestic violence contributes enormously to emergency room admissions. clinicians have a duty to address this violence within the realm of their expertise and the clinical case. nonetheless, not all physicians need take on the public health features of this violence. otherwise their time would be consumed and their other responsibilities to those in immediate need, would be neglected. therefore, there is need for clinicians to observe a certain economy of pretension with respect to the frequent and obvious social dimension of their practice. for us this "clinical parsimony," means that a social ethic of medicine might address itself to the social issues encountered clinically. but the "patient" is now society, and the good is the public's health. the duties and obligations, the characteristics and virtues, of public health physicians are, if not the same as those that engage individual patients are at least analogous. this is not to deny that many illnesses experienced by individuals are caused by social problems, such as poverty, ignorance, poor hygiene, lack of access to safe water, and the like. indeed, these broader causes of illness and disease quite rightly are the subject matter of public health and social medicine, and reflect the adequacy of the provision of health care in any society. thus, in the model of a social ethic of health care we are using the causes and effects of health and disease include social and even cultural conditions. other methodologies are clearly possible in deriving a philosophy of social medicine. some are based upon the idea of limiting clinical pretensions that has guided our thinking. but there are other methodologies that tilt the balance between individual and social concerns in favor of the latter. for many european thinkers, the focus of a philosophy of social medicine is less on its analogies with clinical medicine, and more on the power it engenders in its public relationship to both society and individual patients. the starting point of these models of a philosophy of social medicine is social power, its dominance and frequent arrogance, and the need to reign it in. foucault's empirical philosophy of the clinic fits this model. it is a heuristic theory that not only describes current practices, but also relates these in theory to one's own experiences of illness and repair. feminist bioethics might also be seen as another form of this view, insofar as it focuses upon the power relation of gender within medicine and the vulnerabilities that arise from differences in the social status of genders. similarly, philosophies of medicine that concern the rise and power of technology would be examples of this kind of philosophy of social medicine. in commenting on aristotle's on sense and the sensed object, aquinas grapples with the distinction between the particular and individual in medicine and the more universal causes and effects of medicine. he notes: ...it is for the physician to consider their [universal principles of health and disease] particular principles; he is the artisan who causes health and like any art his must concern itself with the singulars that come under this project, since operations bear on singulars. clinically-oriented physicians are primarily oriented to particularities. nonetheless, the "universal principles of health and disease" are discoverable, analyzable, and manipulatable by persons other than those professing to heal individuals. basic scientists, for example, are charged with, or have taken on, the laudable goals of improving the health of all human beings. furthermore, examining the structures of illness and healing are at least in part the goals of a philosophy of medicine. the individualities pursued by physicians arise from more general causes and return back, mutatis mutandis, to existential structures of human existence through the individual. a good philosophy of social medicine, then, will not neglect the centrality of the clinical encounter as the origin of questions about general causes of illness and disease, as well as the social effects of their neglect or their alteration. in this regard, aquinas notes further: health can only be found in living things, from which it is clear that the living body is the proper subject of health and disease...since it pertains to natural philosophy to consider the living body and its principles, it must also consider the principles of health and disease. ...the study of health and disease is common to philosopher and physician. but since art is not the chief cause of health, but aids nature and assists it, it is necessary that the physician take from natural philosophy the more important principles of his science, as the navigator borrows from the astronomer. this is why physicians practicing medicine well begin from natural science. since the time of aquinas, of course, "natural philosophy" has developed into the whole panoply of physical and social sciences, as well as philosophies of nature and science. yet the insight about general principles arising from the living body and returning through it to common features of human existence is important if we are to avoid the trap of making medicine responsible for all social causes of health and disease. an interdisciplinary and international effort can effect eradication of certain diseases. but medicine alone cannot assure human rights in health care. it must work with other disciplines, playing its restricted role in the clinical arena while articulating it efforts with politics, law, sociology, etc., to guarantee international human rights in health care. by clinical medicine, then, we mean the use of medical knowledge and skill for the healing of sick persons, here and now, in the individual physician-patient encounter. clinical medicine so defined is the activity that defines clinicians qua clinicians and sets them apart from other persons who may have medical knowledge but do not use it specifically in clinical encounters, like the basic scientist or public health physician. clinical medicine is the clinician's locus ethicus, whose end is a right and good healing action and decision for individual patients. similarly, nursing at the bedside, dentistry, clinical psychiatry, social work, etc, each has its own locus ethicus. moreover, clinical medicine is the instrument through which many public poli-cies come to affect the lives of sick persons. no matter how broadly or socially-oriented we take medicine to be, illness will remain a universal human experience. its impact upon individual human persons is the reason why medicine and physicians exist in the first place. using clinical medicine as the paradigm for a philosophy of social medicine does not neglect the other branches of medicine, each of which has its own distinctive end. thus, for basic scientists the end is the acquisition of fundamental biological knowledge of health and illness. this knowledge becomes a part of clinical medicine specifically when it is applied to the needs of a particular human being here and now. similarly, preventive medicine has as its defining end, i.e., the cultivation of health and avoidance of illness. hence, social medicine has its end in the health of the community or the whole body politic. when the knowledge and skills of any of the other branches of medicine are used in the healing of a particular person, then the ends of that branch fuse with the ends of clinical medicine. in clinical medicine, clinical nursing, etc., the good of the patient is the end, primus inter pares. in social medicine, it is the good of society. throughout we have emphasized the primacy of the clinician's ethical responsibilities to be located in the good of his or her patient. under what conditions may this responsibility be balanced by ethical obligations to the good of society? first of all, in situations of natural disaster, just war, epidemics, and overwhelming emergency the clinician's knowledge and skill must be directed to the common good, the larger issue of social and community survival. similarly, when a patient is a threat to the community, e.g. when the patient has a contagious disease and continues to place others at risk, the autonomy of the patient is no longer inviolable. autonomy is limited when it results in the identifiable, probably, grave harm to others. the same is true of patients with hiv infection who refuse to tell their sexual partners, or an airline pilot, locomotive engineer, or crane operator whose condition poses a threat to the safety of others. in short, whenever the good of the patient, as perceived by the patient, poses a definable, grave, or probable risk to identifiable third persons, the physicians covenant with her patient is superceded by her duty to avoid a greater threat to third parties or to society at large. in ordinary circumstances the physician's implicit promise to serve his own patient is a primary obligation. but within that obligation the physician is bound to consider societal good when both good ends can be sensed simultaneously. thus, physicians are obliged to use the less expensive treatment if it is equally effective to the more expensive, even if there is some slight marginal benefit to the latter. even more crucial is the obligation to avoid misuses, abuse, or overuse of treatments or diagnostic procedures. this is a violation of the obligation of competence, which requires the use of modalities of medicine that are effective, beneficial, and not disproportionally burdensome. in the long run, the best contribution the physician can make to conserve societal resources is to practice rational, effective, scientifically evaluated medicine. this happens also to be in the interests of the individual patient as well. this does not mean that the physician should accept or assume the role of rationer or self appointed guardian of society's resources. to do so is to be in a morally unacceptable role of divided loyalty. rationing should be explicit, not implicit. it should be determined by societal and institutional authority. the physician must still inform his patient about what is appropriate treatment. she must try by all legitimate means to obtain what is needed. but the final allocation of resources at both the micro and macro levels is a social not a professional decision. when not joined in a covenant of trust with a particular patient, the physician has several obligations related to the common good. for example, physicians, nurses, and other health professionals are obliged to provide accurate, up to date unbiased technical information to policy makers, institutions, and administrators. they are required to avoid the kind of conflict of interest inherent in misleading exaggerations of benefit to advance one's favorite treatment procedure. conversely, policymakers must be wary of one expert's depreciation of a competitors claims. the expertise of health professionals must be available as a sound factual basis for the decisions of policy and law makers. without it political and economic considerations may distort good standards of care. the requisite objectivity is difficult to achieve in our health care system that is, today, commercialized and market oriented to an alarming degree. academic scientists and physicians are no less susceptible to self interest than their commercial counterparts. it is a rare research scientist who is totally free of conflict between his duties as physician and scientist, and his personal pursuit of self-interest, prestige, and power. yet, without reliable, verifiable, and accurate technical information, health care policy in the interest of the common good is impossible to design. recovery of moral, as well as scientific, credibility has become a major task for today's health professionals. the moral high road is, of course, extremely difficult to follow. without it, however the profession of medicine and the other health professions will lose what-ever moral credibility they still retain. society, in the end, will be the loser. first, because it will be denied reliable technical information upon which to base public policy. second, it will lose the example of one of the few remaining groups among which there is a substantial number who are dedicated to something other than their own self-interest. a society without an island, or two, of morally motivated professionals is a morally deprived society. this takes us to the third level at which the professional may fulfill his or her societal duties and that is a member of a professional association or society. a medical or nursing association is defacto a moral community. its members are united by a common public oath or commitment to act primarily for the benefit of those they purport to serve. they share in addition some set of moral precepts expressed in a moral code. unless these moral dimensions are explicitly rejected, society assumes that they are the ethical signatures of the professions. that professional societies today do not behave as moral communities does not erase the fact that their major ethical justification for existence is to advance the ends and purposes of the professions. if those ends and purposes are no longer moral in nature, professional associations become unions, guilds, or even the conspiracies against the public that george bernard shaw took them to be. while not conspiracies, professional organizations today have become corporations, public relations agencies, and profit making organizations. their size, capital holdings, and budgets are sometimes far in excess of what is required to function as moral communities, that is, as associations of professionals acting collectively to advance the purposes of medicine or the other health professions. those purposes are focused upon the needs of sick persons or societies and not the propagation of self-interest. when they behave as moral communities, professional associations provide effective means whereby health professionals could fulfill their societal responsibilities. these associations should above all be advocates for the sick. they should act collectively via public education and political action to promote a just health care system, one in which the obligation of a good society toward its members to assure access, availability, and just distribution of health care could be realized. associations of health professionals have enormous latent moral power if only they choose to use it. they can influence public opinion, and raise public moral sensitivity to injustices, but only if they are genuinely acting for the good of society and not their own profit. we appreciate how far this notion of professional associations as moral communities is at present from the realities. however, as with all things in the moral realm, we can hope that what ought to be, may in fact, come to be. finally, health professionals can fulfill their social obligations as citizens. here they can be advocates for what they believe to the elements of a just society or health care system. here they can and, of course, will differ. it is here that they can express their own preferences apart from those of their fellow professionals. but here too, their votes and political participation should be guided by a sense of social good that transcends their own selfish self interest. medicine has always existed within a social context in which the uses of medical knowledge and clinical decisions have impacted the good of society as well as the individual patient. in recent centuries the factual foundations for these interrelationships have been demonstrated. as a result, it has become clear that the social repercussions of medicine have serious ethical implications for both physicians and society. we have, therefore, examined the relationship between the good of the individual patients and the common good in an effort to define a morally sound relationship between them, especially when they come into conflict. the proposition has been advanced that a philosophy and ethic of social medicine (or the medicine of society) is required that is comparable to the existing philosophy and ethic of clinical medicine. by comparing and contrasting the ethics and functions of clinical and social medicine some order of priority can be established when they come into conflict. the implications for clinicians in the partition of their ethical obligations to both patients and society are spelled out in terms of both an ethic of clinical and social medicine. while the physician is used as the example, the implications for all other clinicians are essentially the same, within the specific ethical framework of each profession. note: this paper was being written when dr. thomasma died unexpectedly. i have retained him as coauthor although i have revised the text substantially. nonetheless, i believe he would have no objection to the changes a philosophical basis of medical practice, toward a philosophy and ethic of the healing professions for the patient's good: the restoration of beneficence in health care the internal morality of clinical medicine: a paradigm for the ethics of the helping and healing professions diseases of workers ( ), rev., trans. wilmer cave wright medical ethics: a code of institutes and precepts adapted to the professional conduct of physicians and surgeons ( ) complete system of medical polity (system einer vollstandigen medicinishcen polizey) (manheim, schwann, - ) referenced in fielding h. garrison, history of medicine diseases of civilization rationing health care: conflicts within the concept of justice managed care: rationing without justice, but not unjustly (ne a and book i) the imperative of responsibility: in search of an ethics for technological age metaphysics as a guide to morals for the patient's good: the restoration of beneficence in health care another example at this point would be the effort by chinese society to limit the number of children its citizens could have for the sake of reducing its ever-burgeoning population versus the desire of individual citizens to bear children consent, coercion, and conflicts of rights the lingua franca of human rights and the rise of a global bioethic for the patient's good: the restoration of beneficence in health care naming the silences: god, medicine, and the problem of suffering the human person as the image of god human dignity, vulnerability and personhood freedom and community: the ethics of interdependence the face of suffering: the philosophical-anthropological foundations of clinical ethics changing values in medical and health care decision making joseph j. jacobs on alternative medicine and the national institutes of health an example might be the practice of female castration in some african cultures. this practice has been widely criticized by bioethicists and physicians treading carefully on the moral high ground: response to 'dubious premises -evil conclusions: moral reasoning at the nuremberg trials unhealthy societies: the affliction of inequality challenges for a philosophy of medicine of the future: a response to fellow philosophers in the netherlands in the influence of edmund d. pellegrino's philosophy of the birth of the clinic; an archeology of medical perception medicine and the reign of technology technology in medicine: ontology, epistemology, ethics and social philosophy at the crossroads the basic works of aristotle preface to the commentary on sense and the sensed object autonomy and international human rights the internal morality of clinical medicine: a paradigm for the ethics of the helping and healing professions the group tended to expand the definition of medicine so broadly as to absorb or "medicalize" almost all aspects of life. such an expansion defeats any attempt to define ends. it places ends in conflict with each other and weakens any attempt to establish a hierarchy of goods among the many ends "medicine" may serve. see: i. nordin the doctor's dilemma professional medical associations: ethical and practical guidelines key: cord- -u brl bi authors: annandale, ellen title: society, differentiation and globalisation date: - - journal: health, culture and society doi: . / - - - - _ sha: doc_id: cord_uid: u brl bi first, theories of globalisation and their implications for the analysis of health issues are discussed. emphasis is on: ( ) globalisation as embodied, something often overlooked by sociologists working outside of the field of health and ( ) health vulnerabilities that arise from the heightened mobility and connectivities that characterise globalisation, taking migration and health as an illustration. second, differentiation is considered by highlighting disparities in health vulnerability and the capacity of social groups to protect their health. this is illustrated by reference to the securitisation of health and the health consequences of violent conflict and the special vulnerabilities of children and of women. third, the influence of interconnectedness of various national healthcare systems and implications for the delivery of effective healthcare are considered. sociology was born of modernity and the conception of 'society' as a sovereign unit of analysis. since the turn of the present century this has been subject to considerable critical analysis as it has been argued, with increasing force, that the discipline has entered a 'post-societal phase' as a consequence of globalisation, challenging as a consequence sociology's basic units of analysis, namely, the nation-state (burawoy ). urry characterises this as 'a theoretical and empirical whirlpool where most of the tentative certainties that sociology has endeavoured to erect are being washed away ' ( : ) . the effects are several, including the search for new theoretical frameworks and associated conceptual tools which turn from the traditional emphasis on stasis, structure and social order in favour of mobility, contingency and complexity (see e.g. castells ; walby walby , . concurrently, theorists have re-examined the assumptions of modernity, or what it means to be modern, that shaped the discipline. as connell ( : ) expands, 'sociology developed in a specific location: among men of the metropolitan liberal bourgeoisie'. the so-called founding fathers of the nineteenth century, such as durkheim, marx and weber, were concerned principally with the social changes taking place as european societies modernised, processes such as socio-economic restructuring, loss of social cohesion and new forms of social inequality. consequently, the very meaning of modernity itself was eurocentric since the social was conceived as 'an internally coherent, bounded phenomenon that could be understood without any reference to external relations such as the colonial or imperial misadventures that were being undertaken at the time' (bhambra : ) . for example, durkheim's ( durkheim's ( [ ) analysis of the division of labour in society, especially his disquiet about excessive individualism and lack of social cohesion under organic solidarity, was approached overwhelmingly by reference to processes internal to a society. sociologists have questioned the constraints that this presents for an adequate understanding of social life in both the global north and the global south. but as bhambra ( : ) argues, while sociologists are now far more inclined to discuss modernities in the plural, these often refer back to european analysis such that 'the west is understood as the major clearing house of modernity' to the rest of the world, meaning that non-western peoples must now begin to engage their traditions with modernity in different forms of hybrid "modernities"'. as she continues, with globalisation these multiple modernities still tend to be seen as becoming global as they incorporate features of the west to local circumstances. thus, as she puts it, while there is recognition of difference, that difference does not necessarily make a difference to sociological ways of thinking. bhambra ( ) exemplifies this through the analogy of the spokes of a wheel where european modernity of the centre diffuses along the spokes of other parts of the world or countries in relation to their encounters with the west, with very little consideration given to how the spokes may relate to each other. perforce there is a tenacious northernness to sociological theory which can result in the erasure of the experience of peoples outside of the metropole-the majority of the people of world-from the foundations of social thought (connell ). this has sizeable implications for the analysis of society, differentiation and globalisation and health. the connections between 'global' and 'health' are very far from given, rather, as this chapter seeks to show, global health problems and responses are 'enabled, imagined, and performed via particular knowledges, rationalities, technologies, affects, and practices across a variety of sites, spaces, and relations' (brown et al. (brown et al. : . this means it is important not only to consider globalisation's processes and effects but also how they are theorised and the consequences that this might have for our understanding of health and healthcare in different parts of the world. this chapter is organised as follows. part addresses theories of globalisation and their implications for the analysis of health issues. in particular i emphasise that globalisation is embodied, something often overlooked by sociologists working outside of the field of health (turner ) . emphasis is given to the health vulnerabilities that arise from the heightened mobility, and connectivities that characterise globalisation, taking migration and health as an illustration. in part , i turn to consider differentiation by highlighting disparities in health vulnerability and the capacity of social groups to protect their health. this is illustrated first by reference to the securitisation of health and (elbe a) . a focus on the mental and physical health consequences of violent conflict then draws out the special vulnerabilities of children and of women. finally, in part , i reflect on neoliberalism as the dominant politico-economic policy framework driving health system change and on the increasing interconnectedness of various national health systems, and their implications for the delivery of effective healthcare. as turner emphasised over a decade ago, 'we can no longer study the treatment of disease in an exclusively national framework because the character of disease and its treatment are global ' ( : ) . the sociology of health needs to be global in scope and, crucially, the globalisation of health risks and of medical institutions should be added to globalisation theory as 'the first steps toward a globalisation of the body' (turner : ) . while turner underlines that the spread of global health risks and global health institutions can be thought of as a new phase of globalisation, attention in these terms is wanting in most globalisation theories. even so, they can provide a useful lens into the analysis of health in the global context. as already noted, since globalisation is envisaged as a new social order, a substantially new theoretical framework is necessary to analyse what is envisaged as a 'new unbounded social system' (connell : ) . while popular thinking tends to equate globalisation with linear diffusion of western values and ideas to the rest of the world and construe arrested globalisation as resistance to such a trend-such as in the interpretation of the rise of islamic fundamentalism as a direct response to the spread of western political and cultural values into the middle east-most social scientists maintain that globalisation has no one single logic. instead of moving in one direction, they stress that it is multi-dimensional and multi-causal. bauman ( : ) describes globalisation as uncontrolled, operating in what he depicts as a 'vast -foggy and slushy, impassable and untameable -"no man's land"'. similarly for beck ( ) , there is no over-riding logic or driver, such as the economic; rather globalisation is multi-causal and multi-dimensional. consequently it presents as a new form of radically uncertain modernity. according to walby, globalisation is best identified as 'a process of increased density and frequency of international interactions relative to local or national ones ' ( : ) . she argues that this can be grasped most effectively through the lens of complexity theory. this entails a reworking of the concept and theory of society to bring system to the fore but in a substantively different way to erstwhile approaches such as that of parsons ( ) , where social systems were construed as entities made up of parts. by contrast, walby ( ) proposes that sociology should be the study not of parts but of all of society as a set of relations. from this position, she maintains it is possible to 'address multiple regimes of inequality existing within the same territory without assuming that they must neatly map onto each other or be confined to the same borders' (walby : ) . this offers a new vocabulary with which to understand social change; that of co-emergence, non-linear processes and heterogeneity (walby ), which draws attention to features of globalisation such as heightened mobility and new forms of connectivity between people, all of which have health implications. in his theory of the networked society, castells ( ) advances that social structure is always in the making, connecting the local and the global. while mobility is crucial, of equal importance for castells is perpetual connectivity. mobility stratifies through movement and through the lack of it. for some, 'space has lost its constraining quality and is easily traversed in both its "real" and "virtual" renditions' (bauman : ) , increasingly making it possible to move around the world for employment, in search of personal health and well-being and, as discussed in part of the chapter, for healthcare. conversely, there are people, such as refugees, who, for reasons such as civil war and persecution, have no choice but to move and to keep on moving. globalisation also makes visible the world of the 'locally tied' and globally many people are tied to risky communities that are damaging to their physical and mental health. (see chap. .) in collateral damage, bauman argues that 'the inflammable mixture of growing social inequality and the rising volume of human suffering marginalised as "collateral" is one of the most cataclysmic problems of our time' ( ). 'collateral damage' is military in origin and refers to the unplanned effects of armed intrusions. applying it to global societies, bauman conveys how the poor become collateral damage in a profitdriven, consumer-oriented society. although he does not address health and illness, it may be instructive to conceptualise those increasingly vulnerable to health inequity as a form of collateral damage. we turn to look at this now through the example of recent migration and health. the term migrant encompasses multiple forms of mobility. in broad usage, it is often taken to refer to people who move 'voluntarily' to live in another country for a year or more, such as 'economic migrants' and also 'irregular migrants' (those entering a country without required documents). by turn, 'forced migrants' comprises refuges, defined under the united nations (un) refugee convention of as those forced to flee to save their life or preserve their freedom; asylum seekers, or people seeking international protection, awaiting a decision on whether they have refugee status; and internally displaced persons (idps) forced to leave their homes to avoid armed conflict, natural or human-made disasters, or violations of human rights, but who have not crossed an international border. the un convention protects refugees, but asylum seekers and idps have few rights and hence limited protection. the relationship between migration and health is complex for the reason that migrants are a heterogeneous group. nonetheless, it can be useful to draw a general distinction between 'voluntary' and 'forced' migrants. although we need to be wary of overgeneralising, where 'voluntary' movement is concerned, research points to health selection since migrants often are healthier compared to people in their country of origin, yet it is important to recognise that migration itself can carry risks such as those of transit and adjusting to life in a new country. from his in-depth consideration, gatrell ( ) concludes that although migrants tend to be in better health than those left behind as well as than those in the new host population, these relative health advantages attenuate as immigrants adapt their behaviours, particularly their dietary and exercise behaviour, to the norms of the new community. this is borne out by huijts and kraaykamp's ( ) large-scale analysis of immigrant health in europe. based on european social survey data for - , they analysed the health of over , immigrants from different countries who had moved to different european countries. basing self-assessed health on a five point scale (i.e. very bad, bad, fair, good, very good), they analysed foreign born and second generation migrants in europe with a focus on 'origin' and 'destination' effects on health. characteristics of origin were found to have a lasting influence. for example, high levels of political oppression were associated with poorer health in both first and second generation migrants. religion was found also to be influential. notably, first generation immigrants from islamic countries reported better health than those from countries where other religions predominate (all other factors being equal). the authors relate this to socialisation into positive health behaviours such as refraining from alcohol consumption and smoking, although, this did not apply to the second generation, something which they put down to the influence of culture in the destina-tion countries. overall then the health of immigrants shows a strong resemblance to the health of native inhabitants of the country of destination, but there are some lasting effects of origin countries (huijts and kraaykamp ) . the deregulation of wars is one of globalisation's most ominous effects. as discussed further below, most present-day war-like actions are carried out by non-state entities and consequently associated with the erosion of state sovereignty and the burgeoning frontier-land conditions of 'suprastate global space' (bauman : ) . populations who flee conflict in their homelands often find themselves as outcasts in camps where they are neither 'settled nor are they on the move; they are neither sedentary not nomadic', becoming 'undecidables' made flesh (bauman : ) . when analysing forced migration we need to think less in terms of individuals moving in a linear fashion from point a to point b and more of constructed group movement, where the journey from a to b is often protracted and involves periods of stasis in 'transit' locations such as idp and refugee camps, as well as interception stages, such as border controls. such journeys are risk-laden (zwi and alvarez-castillo ) . as gostin and roberts ( : ) relate, 'each stage of the forced migration journey…poses health risks. individuals face armed conflict, famine, or both in their home countries causing physical illness, severe mental distress, and lifelong trauma'. the body of a -year old syrian refugee, aylan al-kurdi, lying on a turkish beach in september is an enduring image of the present european 'migrant crisis'. in alone, people were reported dead or missing in the mediterranean sea as they sought to escape conflict in countries such as syria and afghanistan (unhcr ). other health risks include injury and disability in transit and infectious diseases, such as measles, polio, cholera, tuberculosis, dysentery, and typhoid which can be rife in camps and exacerbated by food insecurity and lack of clean water. a report from unhcr (hassan et al. ) on the mental health and psychosocial well-being of syrians affected by armed conflict draws attention to experiences of violence, exploitation, isolation and losses such as grief for loved ones, homes and possessions. this manifests in helplessness, loss of control and anxiety as well as social withdrawal (especially amongst women and young people), fatigue, sleep problems, loss of appetite, and unexplained physical symp-toms. the authors detail that often suffering is understood as a normal part of life, not in need of medical attention. most arabic and syrian idioms of distress do not separate physical experience and mental symptoms since body and soul are linked in explanations of illness. for example, 'habat qalb or houbout el qalb, literally "falling or crumbling of the heart", corresponds to the somatic reaction of sudden fear', and 'kamatni kalbi "my heart is squeezing"…generally refers to anticipated anxiety and worry' (hassan et al. : ) . the health consequences of forced migration are a powerful illustration of the 'social suffering [that] results from what political, economic, and institutional power does to people, and reciprocally, from how these forms of power themselves influence responses to social problems' (kleinman et al. : ix) . bauman ( ) argues that, from the stance of the more secure in the world, migrants embody ambient fears of precarity and of people whose lives are defined by precariousness and anxiety. the insecure are less able to evade their own vulnerabilities, including fears of loss such as of work, homes and loved ones, that are intensified by their scattered and unpinpointable nature (bauman ) . grove and zwi ( ) draw on 'othering theory' to account for the responses of people in destination countries of the global north to forced migrants. the process of othering marks migrants out as different to 'us' and in the process shores up feelings of normalcy. concurrently migrants are constructed as risky to 'us', as distant and strange others, as needy, as charity cases and as health services queue jumpers who create welfare overload. as grove and zwi ( ) discuss, the language used is that of burden to the neglect of the agency, resilience and skill of many migrants. the health of forced migrants is but one example of the negative health consequences of globalisation. it highlights differential health vulnerabilities and the (in)capacity of groups of people to protect their health, the focus of this section of the chapter. the concept of the 'other', referred to earlier, is a useful frame within which to approach the effects of the securitisation of health in global context. although there is a strong historical connection between health and the security of nations, such as in times of war, the notion of 'health security' is quite recent. the catalyst was the events of / in the year . this occasioned the setting up of the global health security initiative, an international partnership between several countries, including canada, france, germany, italy, japan, mexico, the uk and the us, intended to supplement and strengthen their preparedness to respond to threats to global health, not only in regard to terrorism, but also pandemic infection and bio-chemical warfare. by , 'health security' was high on the global agenda, as reflected in the world health organisation's annual report, a safer future (who ) . the report defines health security as 'the activities required, both proactive and reactive, to minimise vulnerability to acute public health events that endanger the collective health of populations living across geographical regions and international boundaries' (who : ix) . this signifies a two-way relationship between health and security. first, the health of populations is seen increasingly in security terms; that is, there is a felt need to secure population health against threats. concomitantly, the security of nations is viewed in medical terms. in security and global health, elbe ( a) proposes that the medicalisation of security has three dimensions. the first is that national security moves from being only about military capabilities and the hostile intentions of other states to the proliferation of lethal medical problems in the bodies of citizens. an instructive way to consider this, and also to track changes in ways of thinking over recent time, is to consider responses to infectious diseases such as hiv/aids and sars (severe acute respiratory syndrome). the aids epidemic (see also the discussions on aids in chaps. and ), which began over years ago in the s, was perhaps the first time that governments, notably the us as a superpower, began to link pandemics to national security and to worry about the possible effects of illness on us interests abroad (mcinnes and ruston ). several years on in , then us president clinton declared aids a national security threat to the country. first, and perhaps foremost, there was concern with high hiv prevalence in the armed forces in times of war and hence the capacity to protect the nation (elbe a) . with the sars epidemic of , security concerns shifted from armed conflict and the stability of national states to mortality burdens and economic repercussions (elbe a) . sars was traced to guangdong province in china, and thereafter it spread to hong kong, singapore and toronto. by , the who was warning against all but essential travel to these countries. in hong kong, over people were subject to isolation orders. when sars spread to the middle-class private housing complex of amoy gardens in kowloon, the department of health quarantined apartments (although by the time the police arrived most people had already fled). a headline in the singapore straits times of may that year emblazoned that 'sars is like singapore's / '. the security threat attended very much to the economic repercussions. with sars respiratory droplets are produced when an infected person coughs or sneezes; this is largely invisible and unpredictable and hence hard to avoid. during the outbreak people began to keep away from public spaces, to minimise time spent outside home, and to wear face masks. the economic effects were predictable; with the avoidance of travel, retail sales declined and there were less business exhibitions and meetings. it was estimated that the asian region as a whole lost the equivalent of - million us dollars. the canadian government evaluated that three million dollars were lost to the country's economy in the first two weeks alone of the outbreak in toronto (elbe a) . this prompted wider concern that any epidemic outbreak could wreak havoc on the world economy, further boosting the medicalisation of security. the second dimension of the medicalisation of security addressed by elbe ( a) is the expansion of medical power and accompanying influence. at the most general level this is evident in increased involvement of medically trained persons in national security circles, most notably in the us. a key turning point was when then president clinton brought physicians into politics in relation to aids with the objective of using them in helping to defend the us population from disease. of significance here is the shift in emphasis from physicians as not only treating disease in individuals but defending against disease in populations. presently, the us homeland security hosts an office of health affairs which has a division of health threats resilience. the third and final dimension of the medicalisation of security brought to the fore by elbe ( a) is measures to secure, or attempt to secure, population health. the main strategy of governments to protect citizens has been the stockpiling of medical countermeasures to major illness as a readiness or preparedness against future uncertainly highlighted by bauman ( ) as referred to earlier. this is exemplified by the stockpiling by several governments of the global north of the anti-viral tamiflu during the 'swine flu' (h n ) outbreak of . the differential consequences for populations of containment efforts can be illustrated by the race to secure antiviral medications and vaccines in the wake of the possible h ni (avian flu) pandemic in the mid- s. as recounted by elbe ( b) , the majority of cases and of deaths at the time were in indonesia (see also chap. regarding how rural poor women in indonesia are at great risk for maternal mortality, morbidity and infant death). in , the country's government stopped sharing its virus samples to who under the global influenza surveillance network because it discovered that they were being given to western pharmaceutical companies and novel vaccines offered back at unaffordable commercial rates. it is therefore important to underscore that the securitisation of health is practised through, and acts on, the bodies of populations; it is a fundamentally embodied phenomenon involving the surveillance and control of populations, their bodies and their health (see also chap. for a detailed discussion on embodiment). this is now pervasive for the reason that many of the health threats referred to are unpredictable-no one predicted the outbreaks of sars in and ebola virus in - , for example, and it is hard to know where future threats may come from and what they will mean. future health pandemics have rogue status, as depicted in the metaphor of the black swan. initially the notion of black swan was used to refer to unexpected events in financial markets, and then expanded to refer to any surprise event of major proportions. it has been evoked by the us national intelligence council ( : ), which advises that 'no one can predict which pathogen will be the next to start spreading to humans, or when or where such a development will occur. an easily transmissible novel respiratory pathogen that kills or incapacitates more than one percent of its victims is amongst the most disruptive events possible. such an outbreak could result in millions of people suffering or dying in every corner of the world'. uncertainly is associated with both vulnerability and the escalation of agencies of health security. while the securitisation of health might seem to the good for all individuals and all populations, it can also be divisive, highlighting our concern with differentiation. among the questions to be posed are: to what extent is the concern with 'national security' and to what extent with 'human security'? (delaet ) are differential health interests being served? it has been argued (davis ) that the securitisation of infectious disease prioritises the health concerns of western states. in this regard agencies such as who are not neutral actors; diseases come to be identified as a threat when western states feel threatened; after the threats wane so does the support (davis ) . securitisation is then state-centric and shaped by the interests of privileged populations. disease that is seen as containable within national boundaries, such as diarrheal disease and the more hidden burdens such as maternal mortality, infant mortality, hunger and traffic deaths, fails to reach the level of concern that securitised infectious diseases evoke. resources are directed away from public health actors and poverty-related health challenges in ways that do not accurately reflect the global burden of disease (delaet ). based on data reported at the end of , there were extremely violent conflicts going on in the world in (ocha ). as well as deaths, injuries and all the other effects of collective violence, there were . million forcibly displaced persons, including . million refugees, . million asylum seekers and . million idps (ocha ). most contemporary or 'new wars' involve a range of not only state but also nonstate combatants who use violence to pursue exclusionary goals, such as religious, ethnic and economic interests, as exemplified by the civil war in syria. frequently in such contexts, civilian casualty is not a side effect but an aim in itself. to give an illustration, unicef ( ) reports that two million children are living in areas largely cut off from any humanitarian assistance; saw over cases of killing and maiming of children, as well as attacks on schools and hospitals and denial of humanitarian aid to children. when considering the health effects of armed conflict analysts can be inclined to focus on fatalities from direct combat or death from fatal injuries sustained in combat, including the deliberate use of starvation as a direct weapon of war. but, there are other direct effects such as significant physical and mental health problems amongst both the armed forces and targeted and untargeted civilians-such as illness resulting from disabilities (e.g. loss of limbs) and from atrocities of war, such as rape and torture, and sexually transmitted infections. there are also indirect effects of conflict. for example, health facilities, which may not have been of the highest standard even before the onset of conflict, can be destroyed, cutting off access to essential care. moreover, disease spreads in insanitary conditions such as overcrowded refugee camps, and persons living in war-torn environments invariably suffer fear, insecurity and mental trauma (levy and sidel ) . the differentiation of peoples is fundamental here. in frames of war, butler ( ) counsels that wars seek to manage populations by distinguishing lives to be preserved from those that are dispensable. some lives become grievable and others not, since to be grievable a life has to matter rather than to be seen as imminently destructible. violent conflict is then one of the most radical inequalities imaginable as some deaths of some populations or groups are seen as necessary to protect the living of others. as will be discussed later, women and girls, and children in general are often differentially vulnerable. we will now take this further through two case illustrations: the health of former child soldiers and rape of women in war. the term 'former child soldier' refers to children abducted into armies and rebel forces and then returned home. there are an estimated , child soldiers in the world today, of whom, over percent are girls. the participation of children under the age of years in armed conflict is generally prohibited under international law, and the recruitment of children under into conflict is a war crime (amnesty international ). coerced, enticed or abducted, children serve as combatants, porters, spies, human mine detectors and sex slaves. their health and lives are endangered. many are forced to commit atrocities such as killing or maiming a family member in order to break ties with their community and to make it harder for them to return home. a high rate of mental health problems amongst returnees is inevitable, not the least because when they return home they can experience stigma due to perceptions that they are immoral or dangerous. it is unsurprising, therefore, that former child soldiers have high incidences of post-traumatic stress disorder (ptsd), which is associated not only with their experience during war, but its aftermath. betancourt et al. ( ) researched children in sierra leone who were recruited into the national army and civilian defence during the civil war of , most notably the revolutionary united front (ruf), which was responsible for brutal atrocities against civilian populations, including amputations to supress resistance, and large-scale abduction of children. the ruf forced children to commit atrocities including the murder of loved ones. many were subject to repeated rape and forced to take drugs to reduce inhibition against committing violent acts. after the war ended, programs were set up to reintegrate children into their former communities, yet this was very difficult as most faced fear and distrust and girls were seen as sexually promiscuous or defiled. betancourt et al. ( ) studied the role of stigma in mediating children's exposure to war-related events and mental health outcomes. a total of former ruf child soldiers aged between and years were interviewed at the end of the war in and again in with a focus on family and community acceptance and psychological adjustment, especially levels of depression, anxiety and hostility. the researchers found that the large majority of the respondents were involved with the rebels by force with an average age at abduction of years. in all, percent of the girls and percent of the boys reported being a victim of rape; percent of girls and percent of boys had wounded or killed either a loved one or a stranger. levels of depression were high and percent felt local people acted afraid of them, and percent that the local people felt threatend by them. as one child said, 'initially when i arrived [back home], people feared me. some said i was a killer. there were times when i wanted to touch or play with other kids, but their parents will shout at me. i felt bad during those early days' (quoted in betancourt et al. : ) . in conflict zones around the world, military forces use gender-based sexual violence (gbsv) to terrorise, humiliate and demoralise whole communities, including by the spread of a disease such as hiv and of sexually transmitted diseases-a clear illustration of illness as a tactic of war. here the association between the individual and the collective becomes paramount. there has been a tendency to explain rape and sexual violence as random and opportunistic acts of war, that is, outside of the wider structural context of the society concerned. yet gendered structural conditions are crucial. indeed, it is arguably because of the normalisation of women's inequality in a society where gbsv appears logical and instrumental (davis and true ) . though violent conflict and health is not their focus, scheper-hughes and lock's ( ) theorisation of the 'mindful body' is a valuable lens through which to evaluate gbsv. (see chap. for a discussion of 'the mindful body' in the context of embodiment theory.) they draw attention to the individually experienced body-self, and also to the social body and its symbolic and representational uses, and to the body politic, or the regulation and control of bodies, for example in families and in medical systems. research examples illustrate how the individual body, social body and body politics come together to help explain rape and sexual violence in war. in their research on gbsv in south kivu, democratic republic of the congo, kelly and colleagues ( ) found that, absolutely vital though this is, rape goes far beyond individual physical and psychological trauma and becomes a societal phenomenon where isolation and shame often become as important as the attack itself. analysis of focus group data revealed that many interpreted rape as a form of destruction to the community, associated with the spread of disease, the devaluation of women and the breakdown of families. as one respondent put it, 'if you are a girl [who has been raped], your parents will start mistreating you, they can't understand that you have been forced and that it was not your fault. you will never get married. they will throw you away because you are not worth anything; you will lose all value because nobody will marry you' (quoted in kelly et al. : ) . husbands may view their wives as 'contaminated', such as by sexually transmitted infections, and also as morally contaminating since the rape of a wife can result in loss of pride and a feeling of impotence in being unable to provide support (kelly et al. ) . a second illustration of the power of collective structural context on individual experience comes from the serbian occupation of croatia in the early s. olujic ( ) argues that to understand what happens in war we must take account of the pre-war gendered context, especially meanings of female sexuality and the codes of honour and virtue that women represent in the family, alongside the role of men in protecting this honour. as she puts it, 'women's honour reflects that of men's, which, in turn, reflects that of the nation' (olujic : ) . rape can then represent men's inability to protect women, an attack on their honour and a cause of their shame. thereby the individual bodies of women become metaphoric representations of the social body and the injury to their bodies maims the family and the community. based on fieldwork in hospitals in 'post-conflict' erbil, kurdistan, keller ( ) explored women's expression of illness through presenting symptoms such as limb paralysis, convulsions and muteness. in women's own accounts, symptoms such as these were linked to home life, to experiences that were too much to bear and to lack of support. keeler ( ) associated this with the imposition of global neoliberal agendas in the individual and social body: women's trauma narratives become (re)inscribed by their physicians as anti-modern, positioned as belonging to a 'bygone age'. thus 'hysterical women' become a counternarrative to the global prosperity trope and are medically silenced by the 'body politic' to 'expunge non-normative expressions of trauma' (keeler : ) in post-conflict modernity. this occurs by such procedures as 'pain stimulation', including saline injections, the bending back of fingers and the threat of sexual trauma as 'medical treatment'. this illustration directs our attention to the alliances between healthcare and political agendas. in the final part of the chapter, i reflect on the interconnections of healthcare systems and neoliberal political agendas. health systems can be defined as the assemblage of public and private sector institutions and actors concerned with the support of health and the amelioration of illness. even though globally many countries are grappling with common problems, such as increased health needs and demands for healthcare, alongside the rising costs of providing it, there is not one, simple international line of convergence towards a common form of health system. the reason is that health systems are shaped significantly by their centuries-old economic and political regimes. in addi-tion, they take their form from 'national logics', that is, how a society defines and deals with issues of health and illness. equally, cultural factors influence how populations respond to proposed changes to their health system as well as how those external to a country relate to it. even so, without undue risk of overgeneralisation, we can point towards a worldwide drive towards the commercialisation of health systems and, where public provision exists, such as in our case example of the uk, to the rollback of state or public provision in favour of the free market principles. thus, most health systems around the world have or are moving towards a mix of public/private provision. with this point in mind, it has been argued that health services are now as much about investor potential as access to care for patients. tritter and colleagues maintain that health systems are no longer important primarily because they ensure that people gain access to health services when in need and irrespective of their ability to pay, that epidemics are prevented or controlled [...] or that the social determinants of health are addressed as part of public policies. in the emerging context of the reform policies, health systems are important not only as providers of products and services for which people are willing to pay, but also as an investment opportunity within global financial markets. (tritter et al. : ) although they manifest in different ways across health systems, we can point to a set of three shared global influences: neoliberalism (see also the discussions on neoliberalism in chaps. and ) as the dominant politico-economic policy framework driving system change; macroeconomic policies and structural adjustment programmes (saps); and international trade agreements. as addressed elsewhere in this book, neoliberalism can be defined as a project of economic and social change based on the transfer of economic power and control from governments to private markets and the injection of market competition into areas such as education, housing and healthcare which, in many western countries at least, were once part of the welfare state (scott-samuel et al. ) . as discussed in chap. , neoliberalism is usually interpreted as a response to the period of structural crisis of the s when, from mid-decade, countries such as the us and uk witnessed lower rates of financial accumulation and growth, rises in unemployment and rising inflation. neoliberal economic policies encourage financial deregulation and the opening up of trade and investment by resource-rich countries in regions where social conditions afford high returns. up to the late s, the predominant approach to health improvement globally was to strengthen public health systems, especially access to primary health care. this was the position established by the who's influential alma-ata declaration of which brought about access to healthcare as a human right. the world bank (wb), the international monetary fund (imf), the world trade organisation (wto) and other agencies rebuffed this position in the s as they established monetarist policies prioritising the achievement of macroeconomic stability by putting constraints on the growth of money supply and public spending. supranational agencies, such as the imf, wto and the wb, have been key players in the spread of global neoliberalism in the health field. their influence is often indirect comprising the development of trade and investment agreements negotiated at bilateral and multilateral levels and the promotion of market-friendly structures and regulatory reforms. one of the most controversial of wb policies has been the pressure upon countries of the global south to adopt saps. as a condition of receipt of foreign aid and loans, structural adjustments comprise lowering trade barriers, the selling off of state-owned assets and cutting public sector budgets and public sector workforces (rowden ). the stance of the wb is that structural adjustment stabilises economies, promotes investment and generates long-term economic growth. but it has been argued to the contrary that this leads directly to chronic underfunding of local public sector services, collapsing domestic industries in the face of cheaper imports, rural-urban migration, reduced health budgets (and less money for health workers) and the reduction of access to services by local communities. for example, it might be argued that the unpreparedness of liberia, sierra leone and guinea to deal with the ebola virus outbreak of - in west africa was associated with a short-term focus on economic objectives and on profitable sectors, such as minerals (iron ore, gold, bauxite and rubber) at the expense of the public sector. stubbs et al. ( ) explored the effects of imf aid conditionalities on the provision of healthcare in west african countries including the gambia, liberia, nigeria and sierra leonne, between and . the number of conditions put on aid over the period amounted in total to in the region. imf targets, such as budget deficit reduction, were found to crowd out or to reduce the space for investment in the health sector and aid conditions which stipulated staff layoffs or caps on public sector wages limited much-needed staff expansion of doctors and nurses. in other words, conditionalities of aid negatively impacted the provision of healthcare in the countries concerned. the third significant influence on global health systems is international trade agreements, specifically the general agreement on trade in services (gats) and the associated proliferation of bilateral agreements. gats, which came into effect in , was the first set of multilateral rules governing international trade in services, such as education and healthcare, with the object of removing trade barriers. ultimately, since it aims to liberate all services, it is a potential challenge to the sovereignty of national governments over policy-making in relation to public health and the provision of health services. for example, at the time of writing in march , it is not clear whether the transatlantic trade and investment partnership (t-tip) between the eu and the usa, presently in an eighth round of discussions, will exclude the uk nhs (national health service). if it does not then it could give transnational corporations the right to enter the uk market and operate without limits on their activities. for the reasons referred to earlier concerning the different histories and cultural contexts, the organisation of health systems varies considerably in different countries. the us, for example, has always been a privately reimbursed system where citizens pay for care by insurance through employment or out of pocket. by contrast, in the uk health system since the inception of the nhs in most aspects of care have been provided free of charge through taxation. the same broadly applies to the nordic countries, as well as others such as italy. in between this many countries, such as germany, japan, taiwan and france, have social insurance models whereby patients and employers pay into sick funds which contract with a range of health providers. but, to varying degrees and in different ways, almost all are moving towards a blending of public/ private elements. the uk has in many ways been at the fore in this regard, beginning with reforms of the thatcher government in the s. but the approach has been espoused internationally by countries as varied as italy, singapore, india, taiwan, malaysia, the philippines and russia. fundamentally, the intent has been to introduce market mechanisms to control costs. globally, though to varying degrees, healthcare costs have been rising at significant rates. for example, healthcare expenditure as percentage of gdp rose from . percent in / to . percent in in the uk and, for the equivalent period, from . to . percent in the us, and from . to . percent in germany (world bank ). in the uk and most notably england, an internal market was introduced in the early s as a number of gp practices became fundholders who purchased care from hospitals and other providers on behalf of their patients (doh ) . the intention was that this would make them more cost conscious since they would be paying; that is, they would be deterred from referring patients too readily for tests and treatments, and that they would hold care providers, principally hospitals, to account for spending and quality of care for patients (hunter ) . the new labour government of broadly extended this policy, merging general practices into primary care trusts which jointly commissioned services for patients. the late s into the early s saw the further introduction of private providers into the nhs, for example, to run day surgery, pathology and diagnostic services (doh ). in , the new coalition government consolidated this by the setting up of clinical commissioning groups (ccgs) which hold approximately two-thirds of the nhs budget. ccgs currently purchase care on behalf of gps for their patients. moreover, under the new 'any qualified provider' provision, care could be commissioned not only from nhs providers but also from the for-profit and the not-for-profit third sector (charities and social enterprises) (doh ). this overall policy remains in place at the time of writing in with recent concern focusing less visibly on structural reform and more on incapacity to meet demand-for example, in january the british red cross said that the nhs was facing a humanitarian crisis in the face of escalating demand and rising waiting lists for treatment. health, culture and society endorses the enduring conceptual legacies that have shaped and continue to shape our thinking. it seeks to understand not only where we have come from but where we are going to. this has been the focus of the current chapter as we have explored sociology's disquiet with 'society', as its erstwhile unit of analysis. while theorists of globalisation have given relatively little direct attention to matters of health, it has been suggested that the attention to international connections, mobility and new emergent forms of differentiation and inequality can be a useful point of departure for the analysis of health and healthcare. in these terms we have addressed several critical health issues of our time, such as migration and health, the securitisation of health, the health devastation wrought on civilians caught up in violent conflicts around the world, and the commercialisation of health systems. amnesty international globalization: the human consequences collateral damage: social inequalities in a global age why the world fears refugees what is globalisation? cambridge: polity past horrors, present struggles: the role of stigma in the association between war experiences and psychosocial adjustment among former child soldiers in sierra leone rethinking modernity: postcolonialism and the sociological imagination critical interventions in global health: governmentality, risk and assemblage for public sociology fames of war: when is life grievable? london southern theory securitizing infectious disease reframing conflict-related sexual and genderbased violence: bringing gender analysis back in whose interests is the securitisation of health serving? working for patients. london: stationary office the new nhs: modern, dependable. london: stationary office equality and excellence: liberating the nhs. london: stationary office the division of labour in society security and global health haggling over viruses: the downside risks of securitizing infectious disease mobilities and health forced migration: the human face of a health crisis our health and theirs: forced migration, othering, and public health culture, context and the mental health and psychosocial wellbeing of syrians: a review for mental health and psychosocial support staff working with syrians affected by armed conflict immigrants' health in europe: a crossclassified multilevel approach to examine origin country, destination country, and community effects the health debate first do no harm? female hysteria, trauma, and the (bio)logic of violence in iraq if your husband doesn't humiliate you, other people won't': gendered attitudes towards sexual violence in eastern democratic republic of congo social suffering war and public health global trends : alternative worlds. a publication of the national intelligence council ocha (office for the national coordination of humanitarian affairs) embodiment of terror: gendered violence in peacetime and wartime in croatia and bosnia-herzegovina the social system the mindful body: a prolegomenon to future work in medical anthropology the impact of thatcherism on health and well-being in britain the impact of imf conditionality on government health expenditure: a crossnational analysis of west african nations globalisation, markets and healthcare policy the new medical sociology. london: w. w. norton company. unhcr bureau for europe no place for children -the impacts of five years of war on syrian children and their childhoods sociology beyond societies globalization and inequalities: complexity and contested modernities world development indicators: health systems the world health report -a safer future: global public health security in the twenty-first century forced migration, globalisation, and public health; getting the big picture into focus key: cord- - m icqkt authors: kahn, jessica a. title: start now date: - - journal: j adolesc health doi: . /j.jadohealth. . . sha: doc_id: cord_uid: m icqkt nan that you are taking the time to listen to this address. before i start my address, i want to acknowledge how deeply disappointing it was for all of us that our annual sahm meeting had to be cancelled due to the coronavirus pandemic, to protect the health of our members. however, i am thankful to the sahm leaders who have spent countless hours managing this unprecedented challenge for our society. these include the executive committee; our executive director ryan norton and his team at kellen; the program committee, and our board of directors. what i have learned through this experience is that we are a powerful and resilient organization, and we will overcome this challenge and emerge even stronger. how do i know this? because what i have observed over the past weeks is that these constraints are bringing people even closer together and unleashing people's imaginations in all kinds of ways. this challenge has led to so many creative ideas; for example, how our meeting presenters can share content online, how committees and special interest groups can facilitate virtual meetings, and how we can foster networking in innovative ways. you will be hearing much more about these efforts over the coming days and weeks, but what i can tell you now is that we will continue to learn from, connect with, interact with, and support each other over the coming months. so let's now look to our future together, and i'd like to start this address by sharing with all of you some of my emotions as i begin as your sahm president. first, humility. i never could have imagined, when i attended my first sahm meeting as a resident in , that i would be giving a presidential address one day to all of you whom i admire so deeply, and who are doing so much collective good in this world. i am humbled to be following in the footsteps of my heroes and heroines, who established and advanced the field of adolescent health and medicine. today i am thinking especially of dr. jerry rauh, a founder of our field, who was a genuine servant leader and one of the kindest people i have ever met. he established the division of adolescent medicine at cincinnati children years ago, and it is a tremendous privilege to hold a chair in his name. he served as sahm's fifth president, and i'll serve as the th: i know that he would be tickled by that symmetry. i am also thinking of dr. gail slap, who gave the presidential address at the first sahm meeting i attended and thendlucky for medoffered me my first faculty position. she was a brilliant and visionary leader, and she was incredibly supportive of me as a young mother. she encouraged me to flex my hours and take a -week maternity leave after the birth of my third child, which was a revelation and a key reason i remained in academic medicine. finally, i am thinking of dr. manny schydlower. the year he gave his presidential address, , was just a few weeks after my mom had died. i had hesitated to go to the annual meeting, but his words during the presidential address resonated powerfully with me that day and made me realize why i needed to be there. he said, "for many years, i have felt that warmth, comfort, and sense of belonging to an organization that is my professional home and family." recently, after we made the decision to cancel this year's annual meeting, he immediately reached out to reassure us that we had made the best possible decision, with the best interests of all in mind, and he finished with "hard knocks do nothing to sahm's resilience. we are unvanquished. know that you have the solidarity and confidence of our society." this was unimaginably comforting, and an example of what truly great leadership looks like. second, i feel gratitude. for the incomparable opportunity to serve all of you and this organization that i love. for my wonderful cincinnati colleagues, who are here with me, who organized mini-sahm meetings this week, and who are hard at work planning our ohio valley sahm meeting for the fall. and for my amazing and phenomenally supportive family, whom i adore. but most of all, i feel inspiration. if i had to choose one word to describe how i've felt at every one of the sahm meetings i've attended, unquestionably it would be inspired. the word inspire derives from the latin root inspirareeto breathe into. during each annual meeting and throughout the year, my interactions with all of you breathe new energy into me, fill me with determination, motivate me, and give me the resilience i need to "put my hoodie on and get to work," as dr. trent has encouraged us to do over the past year. we inspire each other to go back to each of our workplaces and communities to care for youth and educate others to care for youth. we inspire each other to conduct research that will transform their health and well-being. we inspire each other to advocate passionately for policies and programs that will enable youth to thrive. editors' note: the annual meeting of the society for adolescent health and medicine, originally scheduled for march e in san diego, california, was canceled due to the covid- pandemic. dr. jessica kahn's presidential address was delivered virtually on march , via video chat. it's my hope that by the end of this talk you will be just a little bit more inspired to leaddno matter what your discipline, which career stage you are in, wherever you live in the world, and whatever organization or community you work indto advance the health and well-being of youth. because our youth today face serious threats to their health and well-being: threats that will be insurmountable without your leadership. let's talk about threats to adolescent health, opportunities to address them through your leadership, and how sahm can amplify your leadership. those of you in this room are well aware of the threats to adolescent health and well-being. hiv and other infectious diseases disproportionately affect youth. more than % of all new hiv infections globally occur among youth e years of age [ ]. young black and hispanic men who have sex with men are especially vulnerable, and we cannot overcome the hiv epidemic unless we end the stigma, promote testing, prevent hiv, and keep people living with hiv healthy [ ] . the infection on all of our minds today is the novel coronavirus. although thankfully, most youth appear to have mild disease, we still do not know the risk for youth with underlying medical conditions, and the lives of youth are being disrupted significantly by this pandemic; for example, due to loss of loved ones and social distancing measures that are severely interrupting their personal lives and education. poor sexual and reproductive health is another major challenge for young people aged e years, who account for half of the million new cases of sexually transmitted infections in the u.s. each year [ ] . think about itdthat is million preventable infections if we make education, screening, and treatment more accessible. the u.s. and countries around the world are in the midst of a behavioral health crisis, driven by increasing rates of depression and anxiety and the opioid epidemic. depression is the most common mental health disorder in adolescents and young adults, affecting nearly one in eight each year [ e ]. drug addiction and suicide in young adults are drivers of the devastating decrease in life expectancy we have seen in the u.s. and as the need for services grows, so too does the shortage of trained mental health care professionals. we must focus on closing this gap through training, effective prevention, and advocacy for policy solutions. chronic physical illnesses such as asthma, obesity, diabetes, epilepsy, inflammatory bowel disease, and neurodevelopmental conditions affect %e % of adolescents [ ] . they represent major threats to adolescent health and well-being. finally, youth are at unacceptably high risk for serious injuries and violence. firearm injuries from homicides and suicides are the leading cause of death for adolescents and young adults aged e years in the u.s. [ , ] . we can and must prevent these deaths. all of these conditions are inextricably linked to social determinants of health: conditions in the environments in which people are born, live, learn, work, play, worship, and age. social determinants affect health outcomes, health risks, and quality of life and include neighborhoods, economic realities, education, social and community context, and health care. those of us who care for adolescents have a deep understanding of the drivers of social determinants, including neighborhood crime and violence, poor access to health care, discrimination, incarceration, poverty, and food insecurity. and we understand that structural and systemic issues such as racism, sexism, heterosexism, classism, and ableism exacerbate and even cause many of these conditions (figure ) [ ] . these threats are increasing in today's political climate and in the policy realm, due to health policies that threaten the wellbeing of youth. cuts by the u.s. government to medicaid, defunding of family planning clinics, and bills that prevent evidence-based care of transgender youth are just a few of the policies that seriously threaten adolescent health. so why should we feel inspired, despite these threats and the challenges we face in our work and in our society? because we in adolescent health and medicine are in the unbelievably privileged position to be able to address them and create change. what are our opportunities to improve adolescent health and well-being, or to quote our annual meeting theme, to turn risk to wellness? first, continue to address preventable and treatable adolescent health conditions: hiv, sexual health, injury, violence. second, invest in our health care system and prevention programs to address noncommunicable diseases. third, work to decrease disparities in health and well-being, by focusing our efforts on socially and economically marginalized adolescents [ ] . how can we turn these opportunities into realities? many of you in this room are already deeply involved in this work. we must continuously strive to improve the care we provide to adolescents, using quality improvement methods and learning health systems. we must improve health equity by addressing social determinants of health, and that means talking openly and often about inequities. we must conduct research that will transform adolescent health outcomes. we must grow our workforce and teach the next generation to address major threats to adolescent health. and we must advocate at every level of government for policies that will promote adolescent wellbeing and improve health equitydand this includes voting. the challenges are formidable, but we can't allow ourselves to be discouraged -because our patients and clients are counting on us. we urgently need to inspire each other to create change by leading from wherever we are. so let's talk about leading from where you are. i'll first introduce to you two leadership principles that you can use to accelerate your leadership effectiveness, starting today, then touch on the many opportunities available through sahm to achieve your leadership goals, and end with my commitment to helping you unleash your leadership potential over the next year. first, effective leadership is not positional but relational: it doesn't have to do with accumulating power, but with enhancing influence [ ] . the fundamentals of influence are building selfawareness, practicing empathetic listening, and creating trusting relationships. one of my favorite leadership paradoxes is that the more you give power away, the more powerful and influential you become as a leader. these two photos, of kim jong-un and dr. martin luther king, jr., capture the essential difference between power and influence. the second principle is that leadership development is selfdevelopment and who you are as a leader is driven by who you are as a person; so outstanding leadership is built upon a foundation of self-awareness: understanding your life story, delineating your values, and defining your purpose [ ] . let's talk about each of these foundations. understanding your life story is key to effective leadership, because it's the basis for leading authentically and defining your leadership passion and purpose. you can't check your personal life at the door if you are to be an effective leader. some of the key events in my own life story that had an impact on my leadership are being the child and grandchild of holocaust survivors, and growing up in alabama during the civil rights movement. these have given me a passion for incorporating social justice, equity, diversity, and inclusion into my work. i also had devoted mentors, sponsors, family, and friends who helped me navigate challenging times in my life, and this gave me a deep determination to give back and lift up others. these experiences have driven my career choices and the way i lead every day, and i know the same is true for each of you. delineating your values is also a key to effective leadership: it drives your leadership principles, defines your ethical boundaries, and prepares you to navigate difficult decisions and crises that you will face as a leader. great leaders live their values by making sure that their intentions, words, thoughts, and behaviors align with their beliefs. my own leadership values are integrity, humility, kindness, curiosity, inclusiveness, and service. i come back to them time and time again to navigate challenging situations and recalibrate. finally, leadership effectiveness is maximized when you can define the purpose of your leadership, which represents an alignment of your motivations and capabilities [ ] . if you are operating in the sweet spot at the intersection of these, you will be a powerful and resilient leader. one of the ways in which you can clarify your leadership purpose is by creating a personal mission statement. mission statements help you to focus on and maintain motivation to reach your long-term leadership goals and also communicate your purpose to others. my own is to encourage, inspire, and support family, friends, colleagues, and mentees to find their purpose and soar. andré martin, formerly of the center for creative leadership, describes everyday leaders as those who, in connection with others, accomplish the tasks of setting direction, building commitment, and creating alignment. you have the capability to set direction by articulating your vision for positive change; build commitment by creating trust and accountability with your colleagues; and create alignment by building a shared understanding of goals. in this way, you can be an everyday leader who transforms the lives of adolescentsdin the clinic, in the laboratory, in the community. i'd like to highlight a few of the many everyday leaders in sahm who are doing just that. veronica svetaz, chair of the sahm diversity committee, who founded the aqui para ti youth development program and advocates passionately for health equity. laura grubb, who is doing a spectacular job in leading our sahm advocacy committee. matthew aalsma, who co-chairs the mental health committee and whose research focuses on mental health of youth in the juvenile justice system. nneka holder, who leads work in adolescent vaccination as chair of our sahm vaccination committee. holly fontenot, who leads the sahm nursing research sig and a research program focusing on prevention of hiv and hpv. tornia wyllie, our new trainee representative to the board of directors, whose goal is to develop adolescent medicine in the caribbean. jason nagata, who facilitates the careers of young professionals through both sahm and the international association for adolescent health. and nuray kanbur, our new international chapter representative on the bod and a leader in adolescent medicine in ankara, turkey. as these leaders demonstrate, engagement with sahm can provide enormous opportunities to lead and to unleash the power you have to create change. this aligns perfectly with sahm's missiondto support each of you to lead in the promotion of optimal health and well-being of all adolescents and young adults through the advancement of clinical practice, care delivery, research, and advocacy. there are two ways that engagement with sahm can help you lead: first, by giving you the knowledge, resources, support, and networks needed to lead in your own institutions and communities, and second, by giving you opportunities to lead within our organization. there are so many opportunities to lead through sahm. these include the following: the board of directors, with representation from our trainees, our international members, and our regional chapters; more than committees and subcommittees, from advocacy to health services, and from research to diversity; special interest groups, from spirituality to substance use, and from juvenile justice to college health; and regional and international chapters. other opportunities include engaging with the journal of adolescent health, whose editor-in-chief is former sahm president dr. carol ford; contributing to publications including writing position papers or newsletter articles and serving on the publications committee; participating in advocacy efforts; and involvement in grant and funding opportunities. sahm is led by an elected board of directors, working in close collaboration with our dedicated team at kellen, which is led by the one-and-only ryan norton, our superbly talented executive director. we are in the midst of a strategic planning process that will lead to a positive transformation in sahm's infrastructure and governance, which is foundational to our ability to achieve our vision and missions. the governance review committee, led by dr. nicola gray, has been working diligently over the last year on a deep dive of our governance structures involving data collection from many sahm members. the annual meeting strategic planning committee, led by dr. gina sucato, recently sent out a survey to the sahm membership which is gathering valuable feedback. three early themes that have emerged from this work is that you, our sahm members, want: ( ) improved communication and transparency across the organization; ( ) more clearly defined roles and responsibilities for the sahm board, committees, regional chapters, and special interest groups; and ( ) clearer pathways toward leadership opportunities. you will hear much more about the recommendations of these committees and the changes that will result from your feedback over the coming months, but for now i'd like to focus on my commitment to you over the next year. my primary priority as your president will be to enable you to lead from wherever you are, whether that means leadership within your own institutions and communities or within sahm. i believe that a leader's fundamental task is to unleash the strengths, motivations, talents, and passions of those who they lead, to achieve a shared mission. what unites us all is our mission to promote the optimal health and well-being of all adolescents and young adults, but we each have unique talents and passions, and i believe that our strength and power as an organization is driven by this diversity of interests, this multitude of answers to "why" we do the work we do. one of my favorite quotations, by mark twain, is as follows: "the two most important days in your life are the day you are born and the day you find out why." this is a mosaic of just a subset of our many "whys" (figure ). just think of the transformative power of our work if all of us are leading in our areas of passion toward a shared mission. so, what will i do over the next year to help you unleash your leadership potential and achieve your why, so that individually, you can be most effective in whatever area of adolescent health is your passion, and so that together, we can transform adolescent health? first, i will create opportunities for you to share your personal mission statements and your leadership stories, so that we can all learn from each other, and to scale up the work that so many of you are leading. please share those with me over the coming year, so that i can include them in our sahm matters newsletterdin a section of my president's column called "sahmleads," and through the listserv and web site. second, i will facilitate ways in which members can more meaningfully engage with and lead within sahm, guided by the work of our strategic planning committees and board. third, we will create clearer paths to leadership, including leadership workshops i hope to launch at the annual meeting. fourth, we will ensure that our leadership is diverse in all dimensions: because the more diverse, the better equipped we will be to solve the most complex challenges in adolescent health. and by the way, i am exceedingly proud to be part of an organization whose last presidents were % women; % of whom were african-american. just look at these incredible, powerful women: drs. trina anglin, andrea marks, abigail english, mary-ann shafer, leslie walker-harding, debra katzman, carol ford, tamera coyne beasley, deborah christie, and maria trent. finally, i will launch the process for developing an aspirational strategic plan. our current strategic plan focuses on changes that we must make within sahm to become a more effective organization, and this is foundational to the development of any long-term, aspirational strategic plan. but it is time for sahm to begin to move toward the creation of an aspirational strategic plan to ensure that the adolescents of the future can lead healthy and meaningful lives. in the next e years, powerful forces will affect adolescent health and well-being globally. we in sahmdin partnership with our sister organizations such as the international association of adolescent health and the american academy of pediatricsdare exceptionally well positioned to be the voice for our patients on a national and global stage and to address the following questions: what clinical strategies should we develop and scale that will transform health outcomes and promote equity? how can we harness advances in science and technologydincluding artificial intelligence, big data, and genomicsdto improve adolescent health? how can we advocate most effectively for the issues that will impact adolescent health in the future, such as climate change? how can we maximize our understanding of adolescents across different cultures and their unique strengths and needs? how can we best engage adolescents and families in this work? finally, how can sahm create the workforce of the future by considering demand for adolescent health services and innovations in education and professional development? these are the questions that i and our program committee chairs, drs. anisha abraham and nicholas westers, would like us to begin to consider as an organization over the next year, and which we will come together to discuss during our annual meeting in . i'd like to close with a call to action for all of you. take some time to think about leading from where you are, to reflect on your life story and how it drives your values and purpose, and to sketch out your personal mission statement. contribute your mission statements and leadership stories for the sahmleads section of the newsletter, the listserv, and the web site: to make it easy for you to contribute, i created an e-mail address that i hope will be easy to remember -sahmpresident@gmail.com. in my first president's column in our newsletter, i would like to include a list of sahm members' mission statements. promise that you are going to send me these personal mission statements and leadership stories! step up and get involved in committees, special interest groups, regional sahm chapters, and strategic planning teams. plan to attend next year's workshop on paths to leadership in sahm. reach out and create a developmental network of sahm colleagues to further your career. nominate, support, and encourage diverse colleagues to take on leadership roles. join our work to create an aspirational strategic plan for youth by sending your ideas to me through the e-mail address above. finally, join us in baltimore for the annual meetingdi am confident it's going to be the greatest sahm meeting ever! i'll end with a poem, written by a nigerian poet, ijeoma umebinyuo. she captures beautifully the concept of leading from where you are, with courage and resilience. centers for disease control and prevention. sexually transmitted disease surveillance america's children: key national indicators of well-being national trends in the prevalence and treatment of depression in adolescents and young adults chronic conditions in adolescents society for adolescent health and medicine. preventing firearm violence in youth through evidence-informed strategies office of disease prevention and health promotion our future: a lancet commission on adolescent health and wellbeing discover your true north this poem highlights some powerful emotions that you can harness in your leadership. tap into the inspiration from your sahm colleagues to turn your fear into activism and your pain into empathy; to transform your doubt into confidence and those shaking hands into healing hands; and to convert that trembling voice into a powerful voice to advocate for adolescents.as i start as your sahm presidentdwith humility, gratitude, and inspirationdi invite you to find your why and start nowdand i look forward to traveling on this journey with all of you. key: cord- - p efxo authors: daniels, norman title: resource allocation and priority setting date: - - journal: public health ethics: cases spanning the globe doi: . / - - - - _ sha: doc_id: cord_uid: p efxo there has been much discussion of resource allocation in medical systems, in the united states and elsewhere. in large part, the discussion is driven by rising costs and the resulting budget pressures felt by publicly funded systems and by both public and private components of mixed health systems. in some publicly funded systems, resource allocation is a pressing issue because resources expended on one disease or person cannot be spent on another disease or person. some of the same concern arises in mixed medical systems with multiple funding sources. risks matters, not just the aggregate impact. resource allocation in public health thus focuses on deciding what risks to reduce-which depends in part on their seriousness as population factors and who faces them-and how to reduce risks. the cases in this chapter that discuss resource allocation force us to contemplate decisions about priorities in public health as opposed to the more frequently discussed medical issues about health care priorities. later we suggest that making decisions about these issues should be part of a deliberative process that emphasizes transparency, stakeholder participation , and clear, relevant reasoning. collectively, these resource allocation cases bring out several important points. separately, they raise other central issues. it is worth noting these general issues before commenting on the more specifi c problems raised by each case. the fi rst point the cases collectively make is that effi ciency has ethical and not just economic importance (daniels et al. ) . if one health system is more effi cient than another, it can meet more health needs per dollar spent than the less effi cient one. if we want systems to meet more health needs, and we should, then we prefer more effi cient health systems. specifi cally, if we think we have obligations to meet more health needs, or if we think meeting more "does more good," and we ought to do as much good as we can with the resources we have, then we have an ethical basis for seeking more effi cient health systems. the economic pursuit of effi ciency should not, then, be dismissed as something that has no ethical rationale. a second point the cases collectively make is that effi ciency is not the only goal of health policy , for we have concerns about how health benefi ts are distributed as well as how they add up. health policy is not only concerned with improving population health as a whole, but also with aiming to distribute that health fairly (daniels ) . that means many resource allocation decisions involve competing health policy goals. the point about competing goals is illustrated by a problem often encountered in policy decisions: should we always favor getting the best outcome from the use of a resource, or should we give people "fair" chances to get a benefi t if it is at least signifi cant (brock ) ? for example, during an i nfl uenza pandemic, should we allocate ventilators to those with the best chance of survival, or should we give signifi cant but lesser chances to a broader group? reasonable people often disagree about when the difference in expected benefi ts means we should favor best outcomes over fair chances, or even about what counts as a fair chance. hence, a third point emerges from the cases taken collectively: reasonable people often disagree about the choice, and it is not possible to simply dismiss one side as irrational or insensitive to evidence and argument (daniels and sabin ) . indeed, reasonable people will disagree about how much priority to give to the sickest (or worst off) patients. they may think we have to weigh the seriousness of an illness against the potential benefi t that we know how to deliver, they may disagree about how to trade off those considerations, or they may disagree about when modest benefi ts to larger numbers of people outweigh greater benefi ts delivered to fewer people. together these "unsolved rationing" problems-the best outcome versus fair chances problem (when to prefer best outcomes to fair chances), the priorities problem (how much priority to give to those who are worst off), and the aggregation problem (when do modest benefi ts to more people outweigh significant benefi ts to fewer people)-mean that there is pervasive ethical disagreement underlying many resou rce allocation problems (daniels ) . there are other common sources of disagreement. one of the most common sources of controversy in resource allocation decisions arises when a particular intervention is seen as the last chance to extend life by some-a necessity if we are to act compassionately-and when it is seen primarily as an unproven intervention by others that we have no obligation to provide it. denials of such interventions in last-chance cases have been considered the "third rail" of resource allocation decisions (daniels and sabin ) . here we have two competing public value s-compassion and stewardship-and most public offi cials would prefer to be seen by the public as committed to saving lives rather than as ha rd-nosed stewards of collective resources. the cases taken collectively bring out one fi nal point: our main analytic tools for aiding resource allocation decision making are limited in several ways, particularly by insensitivity to various ethical issues, especially issues of distribution. in short, these tools may take the fi rst point, about the importance of effi ciency , seriously, yet fail to help us with the second and third lessons the cases collectively bring out, that we are also interested in distributing effi ciently produced health fairly, and that reasonable people disagree about how to do that. to see this, consider two widely used tools: comparative effectiveness research (cer) , which has been given prominence as a r esearch focus in the patient protection and affordable care act of , and cost-effectiveness analysis (cea) . both help to answer policy-making questions. for example, a typical use of cer compares the effectiveness of two interventions (drugs, procedures, or even two methods of delivery), and policy makers may want to know if a new technology is more effective than older technologies. of course, they may also want to know if the new technology provides additional effectiveness at a reasonable cost , which points to a shortcoming of much cer in the united state s, where considerations of cost are generally avoided. similarly, if there is only one effective treatment for a condition, cer tells us nothing useful. it also tells us nothing about whether a more effective intervention is worth its extra cost. and, cer cannot help us compare intervention outcomes across different disease conditions, since it uses no measure of health that permits a comparison of effectiveness. indeed, decision makers face many resource allocation questions that cannot be answered by cer, even if cer can help avoid wasteful investments in interventions that do not work or that offer no improvement ov er others. in germany, however, cer is combined with an economic analysis that takes cost into account and that allows the calculation of " effi ciency frontiers " for different classes of drugs (caro et al. ) . presumably, this method could be extended to different classes of public health interventions if they are grouped appropriately. to calculate an effi ciency frontier, the effect of each drug in a class in producing some health outcome is plotted against its cost , and the curve is the effi ciency frontier for that class of drugs. it is then possible to calculate if a new intervention in that drug class improves effectiveness at a price more or less effi cient than what is projected from the existing efficiency frontier. this use of cer allows german decision makers to negotiate the price of treatments with manufacturers, rejecting payments that yield ineffi cient improvements. german policy makers can then cover every effective intervention sold at a price that makes it reasonably effi cient. still, because german use of cer cannot make comparisons across diseases, it allows vast differences in effi ciency across conditions. cea aims for greater scope than cer. it deploys a common unit for measuring health outcomes , either a disability-adjusted life year (daly) or a quality-adjusted life year (qaly) . this unit purports to combine duration with quality, permitting us to compare health states across a range of disease conditions. with this measure of health effects, we can construct a ratio (the incremental cost-effectiveness ratio, or ic er) of the change in costs that results from the new intervention with the change in health effects (as measured by qalys or dalys). we can then calculate the cost per qaly (or dal y) and arrive at an effi ciency measure for a range of interventions that apply to different condi tions. critics have noted p roblematic ethical assumptions in the construction of the health-adjusted life-year measures and in the use of cea (nord ; brock ) . to see some of these problems, consider the following table: rationing problem cea fairness priorities no priority to worst off some priority to worst off aggregation any agg regation is ok some aggregations ok best outcomes/fair ch ances best outcome s fair chances cea systematically departs from judgments many people will make about what is fair. the priorities problem asks how much priority we should give to people who are worse off. by constructing a unit of health effectiveness , such as the qaly, cea assumes this unit has the same value , regardless of who gets it or wherever it goes in a life ("a qaly is a qaly" is the slogan). but intuitively, many people think that a unit of health is worth more if someone who is relatively worse off (sicker) gets it rather than someone who is better off (less sick) (brock ) . at the same time, people generally do not think we should give complete priority to those who are worse off. we may be able to do little for them, so giving them priority means we would have to forego doing more good for others. few would defend creating a bottomless pit out of those unfortunate enough to be the worst off. similarly, cea assumes that we should aggregate even small benefi ts. then, if enough people get small benefi ts, it outweighs giving large benefi ts to a few. but intuitively, most people think some benefi ts are trivial goods that should not be aggregated to outweigh larger benefi ts to a few (kamm ) . curing many people's colds, for example, does not outwei gh saving a single life. finally, cea favors putting resources where we get a best outcome, whereas people intuitively favor giving people a fair (if not equal) chance at a benefi t. locating an hiv/aids treatment clinic in an urban area may save more lives than placing a clinic in a rural area, but in doing so, we may deny many people a fair chance at a signifi cant benefi t (daniels ) . in all three of these examples of rationing problems, cea favors a maximizing strategy, whereas people making judgments about fairness are generally willing to sacrifi ce some aggregate population health to treat people fairly. in each example, whether it is giving some priority to those who are worse off, viewing some benefi ts as not worth aggregating, or giving people fair chances at some benefi t, fairness deviates from the health maximization that cea favors. yet we lack agreement on principle s that tell us how to trade off goals of maximization and fairness in these cases. people disagree about what trades they are willing to make, and this ethical disagreement is pervasive. determining priorities primarily by seeing whether an intervention achieves some cost/qaly standard is adopting a health maximization approach. this approach departs from widely held judgments about fairness, even where people differ in these judgments. thus, the national institute of clinical and health excellence (nice) in the united kingdom has had to modify its more rigid practice of approving new interventions only if they met a cost/ qaly standard in the face of recommendations from its citizens council. this council, intended to refl ect representative social and ethical judgments among british citizens, has proposed relaxing nice's threshold in various cases where judgments about fairness differed from concerns about health maximization. the judgments of the citizens council in this regard agree with what the social science literature suggests are widely held views in a range of cultures and contexts (dolan et al. ; menzel et al. ; nord ; ubel et al. ubel et al. , . there are, of course, those who criticize departures from the nice threshold of the sort that the citizens council recommended. compromising the maximization of health that cea promotes may be seen as a moral error, perhaps the result of elevating the rescue of an "identifi ed" victim (say, a cancer patient whose life might be extended modestly by a new drug) ove r benefi ts to "statistical" lives (using the resources to provide greater benefi ts to others). the reasonable disagreement about how to proceed suggests that we should view cea as an input into a discussion about reso urce allocation, not as an algorithm for making decisions. this "aid to decision making" role was proposed by the public health service in its recommendations about the use of cea (gold et al. ) . in short, controversial ethical positions are embedded in cea, and using cea uncritically commits one to these views, even though many disagree with them. we have already noted that the effi ciency of a health system has ethical consequences. but what should we count as effi ciency ? should we use our resources to generate more revenues for a unit of the health system-say, a hospital? doing so would defi ne effi ciency the way most businesses do: other things being equal, an allocation that produces a greater return on investment is a more effi cient use of stockholder or owner resources. alternatively, we might narrow the range of effects to health effects on the covered population . then we have greater effi ciency when an allocation produces more positive health effects in that population than an alternative allocation. the case guzmán brings from colombia raises this issue forcefully. should hospitals, or a specifi c health plan, allocate resources favoring services (certain treatment s) that raise more revenues than an alternative allocation (certain preventive measures)? perhaps the gains from the treatments will involve fewer population health gains over time than those obtained by the preventive or health promotional measures, even if they show their improvement more quickly and so look better sooner. which plan should the policy maker adopt? this issue examines our purpose in designing a health system. is it to meet the health needs of a population or is it to provide a good return on investment for those who invest in health services? we might think that this question is easier to answer in a system where health care delivery is seen largely as a public undertaking aimed at improving population health. in such a system, it might seem that there is only one purpose behind the health care system. return on investment for the taxpayer funding such a system should be measured by how effi ciently the system improves population health. in systems where resources are owned privately (and there are many of these), however, it seems we must consider at least two goals. even if the private sector must in part seek to improve population health , which may be a requirement of state-imposed health care regulation or, in some people's opinions, a social responsibility of corporations, private health-care organizations still must deliver a reasonable return on investment for owners. thus, policy makers within private health-care organizations have a dual task. balancing return on investment with improvement in populatio n health thus becomes the central issue in the colombian case study. the chilean case written by gómez and luco raises a similar issue, but this case focuses on measurable differences in the cost effectiveness of certain services and in the severity of two conditions. if we consider only cost effectiveness, we view effi ciency in one way-the best health outcomes in the aggregate for the population for an investment in health. if we take severity of condition into account, we might view this as an equity demand-in which case, we have an effi ciency-equity confl ict and must make a trade-off. or, we might think of effi ciency as a ranking of needs by severity of condition. in the latter, the resource allocation case turns on how we defi ne effi ciency. specifi cally, the chilean category of guaranteed health interventions could include cataract surgery (the leading cause of blindness in the chilean population), but not multiple sclerosis (ms) treatment s, which might be viewed as maximizing effi ciency in a standard sense. or, the guaranteed health interventions scheme could include the less cost-effective treatment of ms but not cataract surgery, since ms is viewed as a more severe condition (because it can be life threatening and lead to premature death), even if it is far less prevalent than cataracts. if this were the case, the more effi cient system, in this nonstandard view, would rank treating more severe conditions as more effi cient than treating less severe conditions. if budget limitations mean only one should be included in the guaranteed health interventions program, either m s or cataract surgery, which should it be? the cataract surgery intervention delivers a signifi cant benefi t in terms of qalys to a larger part of the population than does the intervention package for ms, but the greater severity of premature death seems to be an important reason for favoring ms. if this reason is given priority over cost effectiveness and over the standard view of effi ciency , then are less effective treatments for more severe conditions supposed to have priority over more effective and cost-effective treatments for less severe conditions? if so, what kind of a health system does that produce if all needs can not be met given resource limits? alternatively, do we want a system that always we ighs cost effectiveness more highly than the severity of a condition that some people have? that too seems problem atic. suppose we think improving population health is a worthwhile and defensible goal of a health system, we favor improving population health over increasing revenues for the private sector (in the guzmán case), and we also favor giving priority to cost effectiveness over severity of a condition (in the gómez and luco case). a confl ict still remains between health maximization in the aggregate and concerns about equity , as illustrated in the blacksher and goold case (and arguably in the case about triage in pand emics by smith and viens). in the case that blacksher and goold describe, the task is to decide whether to reallocate resources from a program focused on maternal-child health and reduction of b lack-white in fant mortality dis parities to a program that may get more health per dollar spent through other interventions. infant mortality among blacks and whites has declined rapidly in the united state s; and in absolute terms, the decline has been more rapid for blacks. still, the ratio of black infant mortality to white infant mortality has increased. because the public health department is in a highly segregated city, this shift in program focus might seem to require viewing the remaining bl ackwhite health d isparities as morally a cceptable (especially given the high rate of improvement that past programs gave to black infant mortality rates). when should we view health disparities as morally acceptable? when should we weigh reducing health disparities as more important than some aggregate gains in health that we know how to produce in a population ? if public health has two goals-improving population health and distributing that health fairly-how should we weigh the goals when they confl ict? one important feature of the blacksher and goold case, namely the opinions within the community whose inequalities are at issue, is really a feature to which nearly all cases warrant attending. people affected by a policy ought to have some infl uence in determining that policy. some people might believe this is what democracy requires. a diffi culty this view of democracy faces, however, is that those who speak for the community may not appropriately represent the community affected by the decision. nevertheless, the opinions of a broader range of stakeh olders may improve deliberation (depending on how those opinions are managed). it may also improve the acceptance of the decisions, which arguably enhances the legitimacy of the decision-making process . resistance to including a broader range of stakeholder s in decision making about health priorities may come from a concern that they bring with them "partiality." this resistance may come from the view that greater impartiality leads to better deliberation. arguably, this concern about partiality ignores the positive gains that partiality often brings to deliberation, especially if we know how to manage such deliberation so that we minimize the risk s that partiality sometimes brings. we need such management skills in any case since partiality is unavoidable in most contexts. rather than banning what cannot be eliminated, managing partiality in deliberations is the best way to improve decision making in contexts of reasonable disagreement. the confl ict between improving population health and treating people fairly can arise in other contexts. arguably, the problem raised by smith and viens about the principle that should govern triage in pande mics can be viewed as a confl ict between health maximization, in this case, saving the most lives, versus recognizing the claims that the sickest people have on us for assistance. ordinarily, health systems give some priority to those who are sickest, but should that priority disappear in favor of saving lives when scarce resources, such as ventilators, are allocated in pandemic conditions? if we allocate our ventilators to the sickest patients, we may save fewer lives than if we allocate them to those whose lives we can better expect to save. even if we think we should give priority to those worst off, do we ordinarily think that concern for them should govern triage policy in pandemics? if we believe saving the most lives trumps concerns about helping those who are sickest in pandemics, can we justify why the priority we give to the sickest should be revised in pandemics? suppose we have an acceptable way of measuring the burden of disease in a population , and according to this measure, mental illness is not given the priority it ought to have. that is, it contributes more to the burden of disease than is normally recognized in standard health systems, which provide too few services to meet mental health needs. this is the problem upon which rentmeester et al.'s case focuses. specifi cally, some mental health conditions require signifi cant resources for what medicaid terms as "behavioral management," which is seen as a social support service not a medical treatment . as a result, these services, to the extent they are provided, fall to state-funded social service budgets. the services place a burden on state fi nances that would be diminished if they were instead included in medicaid bud gets ( % of which are fi nanced by each state). arguably, the stigma that attaches to mental health issues is one important reason for this underprovision of social supports for people with mental health issues. in nebraska, the political opposition to expanded medicaid coverage through the affordable care act ad ds to the burden on state budgets and the potential under-servicing of these mental-health induced needs. it takes resources to meet public health needs. suppose we can increase the resources to meet some of those needs by accepting a pu blic-private partnership that improves a compromised private partner's image? should we meet health n eeds at this price? that is the issue posed by the hernández-aguado case from spain . specifi cally, should public health authorities put their stamp of approval, in the form of their logo, on fl u epidemic notices printed on soft drink labels? the inclusion of the logo is a requirement of the private entities that are willing to donate space on the labels of their products. obviously, this provides a form of public support for soft drinks that arguably contribute to obesity in a population and thus to the prevalence of noncommunicable diseases associated with obesity. but in view of the low budgets available for fl u warnings, is this a price worth paying? what would the decision maker have to know about the effects of such labels to decide this case, or is the decision something that can be made independently of the specifi c payoffs of implementing the warning system? is there a way to consider the cost and assess whether the outcome of the warning is worth this price? is this simply an effi ciency calculation about the cost effectiveness of reducing a disease burden in this way? one fi nal crosscutting issue lurks behind all the cases in the resource allocation chapter (perhaps all the cases in the volume)-namely, the nature of the decisionmaking process that addresses the issues they raise. public health decisions about resource allocation-judging from the cases on that topic in this volume-face reasonable ethical disagreement. that is because the tradeoffs involved in the two main goals of public health policy -improving population health and distributing health fairly-are trade-offs about which people often reasonably disagree. how can public health decisions be made in real time, given these ethical disagreements, in ways that enhance their legitimacy and are arguably fair to all parties? one approach to the problem is to construct a fair process for making those decisions and to rely on the outcomes of such a process. people will judge the outcomes of a fair process to be fair (daniels and sabin ) . what conditions should such a decisionmaking process meet if it is to be considered fair? four conditions are arguably necessary (even if some may think they are not suffi cient and want to add others): ( ) the decisions and the rationales for them should be made public. ( ) they should be based on reasons all think are relevant. ( ) they should be revisable in light of new evidence and arguments. and ( ) , these conditions should be enforced so that the public can see that they obtain. some explanation is needed for these conditions. the publicity condition is widely embraced, even if it is fairly strong. it calls for the grounds for decisions-not just the content of the decisions-to be transparent. people have a right to know why decisions that affect their health are made the way they are. moreover, making the reasoning for such decisions public is a way of exposing them to scrutiny so errors in reasoning or evidence can be detected and decisions improved. even though we may not be able to be explicit in advance about all criteria we use to decide such cases, that is, we may work out our reasons through deliberation, we can explain on what we base our decisions. and that gives people affected by our decisions the knowledge they have a right to possess. the search for reasons that all consider relevant to making a reasonable public health decision about resource allocation can narrow disagreement considerably. even if people can agree on what reasons they think are relevant-in the spirit of fi nding mutually justifi able grounds for their decisions-they may not agree about the weight they give these reasons. one way to test the relevance of such reasons is to subject them to scrutiny by an appropriate range of stakeholder s. what counts as appropriate may vary with the case. who should be heard in deliberations is itself worthy of deliberation. stakeholders raise different arguments that should be heard, and including their voices improves buy-in to decisions. since stakeholders may not in many instances be elected representatives, we may be skeptical about whether the democratic process is improved by including them, but, if the deliberation is well managed, the quality of the discussion may improve greatly. the revisability condition , requiring that decisions be modifi able in light of new evidence and argument, is also widely embraced and not considered controversial. decisions are made on the basis of evidence and arguments, and better evidence and arguments may emerge that require revisiting some decisions. some decisions can then be modifi ed, though it may be too late for others, and our consolation is that we made the best choices we could, given the evidence and arguments. the intent of the enforcement condition is to ensure that the other, more substantive, conditions are met. sometimes enforcement is a matter of state regulation . sometimes it can be the result of vol untary conformance with a process. since ethical disagreements abound in resource allocation decisions , we need a process that enhances legitimacy. but can we claim that a decision-making process that is fair yields fair outcomes? one view is that we may ultimately become persuaded by a good argument that fairness requires a different decision than one that emerged from a fair process. we can in this way defeat the fairness we might ordinarily attribute to the outcome of a fair process. does the prospect of defeating the fairness of a decision emerging from a fair process mean that we should not attribute fairness to the outcomes? alternatively, we can admit that the fai rness that comes from a deliberation is only "defeasible" fairness, but it is the fairest conclusion we ca n reach at the time. during the s, many latin american countries began reforming their health systems according to a neoliberal development model that emphasizes free markets (homedes and ugalde ; stocker et al. ) . approved in , health reform in colombia was supposed to overcome problems such as low coverage, inequality in access and use of health care services, and ineffi ciency in the allocation and distribution of resources. but the reform also hoped to encourage more focus on illness prevention and health promotion and more community participation in health decision-making processes. the reformers advocated predominantly for neoliberal value s like effi ciency, free choice, universality, and quality. although they were also committed to the communitarian values of solidarity , equity , and social participation . the colombian health reform was one of the fi rst examples of implementing managed competition in the developing world (plaza et al. ) . to stimulate competition among insurers and health service providers, both public and private, health reformers applied the theory of managed competition (enthoven ) . according to this theory, competition achieves effi ciency and reduces cost , making health care services responsive to consumer needs (londoño and frenk ) . hospitals become responsive when they are able to sell services and become fi nancially sustainable. to achieve sustainability, supply subsidies (direct transfers from the state to hospitals) had to replace demand subsidies (transfers directed to the poor through a subsided s ecurity plan). the colombian reform established a general social security system in health that featured two insurance plans: ( ) the contributory plan, fi nanced by mandatory contributions (formal employees and employers from the public and private sectors). ( ) the subsidized plan, funded by resources from the contributory plan and from taxes and other sources, which covered people unable to pay (vargas et al. ) . the actors of the system are the insurance companies, the health service providers, and the state regulatory organizations. insurance companies contract with health service providers, and the regulatory organizations control compliance with the defi ned basic health packages. to optimize resources, the reform placed controls on medical practitioners and established explicit priority criteria based on clinical guidelines that defi ned benefi t packages. from , some adjustments to the reform have been introduced, such as the creation, in , of the institute for health technology assessment to provide a n evidence base for health decisions. the institute recommends which medical technologies should be paid with public resources on the basis of which technologies optimally improve the quality and cost effectiveness of medical care. to determine these technologies, it conducts health outcomes research that guides technology development, evaluation, and use (giedion et al. ) . nevertheless, years later, the promise of reform lies unfulfi lled and many patients still experience high out-of-pocket costs, long wait times, or denial of services. to access health services, frustrated citizens are turning to the legal system as a last resort and, by so doing, congesting the courts (defensoría del pueblo ). physicians are responding to economic incentives and penalties by restricting hospitalization time and decreasing the use of expensive diagnostic tests and specialist referrals (abadía and oviedo ) . to further reduce labor costs, service providers have increased the workload of health profession als and the number of patients seen per day, whi le reducing the time spent with each patient (defensoría del pueblo ). insurance companies often take a long time to pay health service providers, and they also contract their own service network (a process known as vertical integration), so many public hospitals are in serious fi nancial diffi culties. meanwhile, hospital workers frequently disrupt the normal operation of hospitals as they strike to improve work conditions and have their paychecks issued more promptly. should hospitals fail- % of the public hospitals in colombia are classifi ed as being at medium or high fi nancial risk -nearly ten million people could be left without health service (ministerio de salud y protección social ; quintana ) . add to that, the reforms have increased inequity, as more affl uent patients can more easily access quality health care services than can low-income patients (vargas et al. ) . the described problems refl ect a complex situation that requires profound structural reform . as one way to address the immediate problems of effi ciency and quality, colombia in instituted public hospital accreditation. accreditation requires hospital directors to reach goals in service delivery related to fi nancial viability, quality, and effi ciency. hospital boards can now fi re directors who fail to meet these g oals within a specifi ed period (rodríguez ) . given the imbalances between budgets, service demands, and ongoing costs, hospital directors face enormous challenges and ethical dilemmas in formulating and executing their mana gem ent plans. you are a director of a public hospital that focuses on health promotion and prevention activities, such as general practice, dentistry, clinical laboratory, hospitalization, and emergency care. in developing your management plan, you must make decisions about which services to prioritize . if you prioritize services that represent higher revenues and lower costs as a way of conserving resources, you may have to reduce priority for some services. to guide your decision making, you conducted a retrospective study of service billing in the past years and learned that the clinical laboratory and external medical consultation yielded higher incomes. the lowest yielding programs in the short term-vaccination , educational programs to improve lifestyles , and provision of micronutrient supplements to children and pregnant women-were associated with the best long-term health results. taking seriously your fi duciary responsibilities, you try to guarantee fi nancial sustainability by containing labor costs, restricting consultation times, and shortening hospital stays. your challenge is to do these things without diminishing the quality of patient care. but because you compete with other institutions, you must also assure suffi cient reserves to maintain and update medical equipment that will improve the "sale of services." knowing that every management decision you make will affect the population you serve, you begin to refl ect on the factors affecting your h ospital man agement plan. . who are the major stakeholder s in this case and what are their interests, value s, and moral claims? between which of them are there ethical confl ict s or tensions? . which of these interests, values, and moral claims should be prioritized? how would you justify your priorities? . would you prioritize programs that in the short term brought in needed revenues or those programs that had highest impact long term? . how can tensions between the goals of effi ciency, fi nancial viability, and quality be resolved? what weight should be assigned to each goal by the hospital board when evaluating your performance? . at least in the short run, the new reforms seem to be prioritizing effi ciency, viability, and quality over equity . should a health system attain the former goals before tackling the problem of equity, or should it insist on equity from the start? . can equity in health care be achieved without doing something about wealth inequity and other social determinants of health? . should you justify your decisions by emphasizing solidarity with other hospital directors and seeking community support? . how could collaborations between public health, communities and the health care system begin to address neoliberal concern s with effi ciency, viability, and quality? the global burden of disease (gbd) compares disease burdens based on epidemiological measures of prevalence, mortality, disability, and associated cost s. the gbd for mental illness amounts to % of the world's total disease burden (world health organization ). i n the united state s alone, every fi fth child suffers from a mental disorder (perou et al. ) . although mental illness clearly causes disabilities (prince et al. ), underservice to those with mental illness is commonplace. lack of access to mental health services counts as the fi rst of many hurdles facing families who have a child with a mental illness. stigma and the lack of parity in health coverage for physical and mental illness are other hurdles for these families. not surprisingly, these hurdles can critically affect the development of children with mental illness. lack of access to mental and behavioral health services for children years and younger especially threatens their development. rapid brain growth occurs in the fi rst years of life, which lays the foundation for cognitive, emotional, and moral development. exposure to chronic stress can prompt the release of hormones in the brain that can have enduring consequences for how the adult brain is organized and how it functions (shonkoff and phillips ) . because poor health can show up in children as developmental delay, access to mental and behavioral health services is critical. longitudinal studies demonstrate positive and long-acting effects of early childhood interventions, such as environmental enrichment programs, on a range of cognitive and noncognitive skills, social behaviors, academic achievement, and adult job performance (heckman ) . the esti mated annual rate of return on investment from targeted early childhood development programs is %, and early intervention reduces the predictable need for higher, more costly levels of care in later life (heckman et al. ) . in the united state s, medicaid is a government-funded program that provides health coverage to people with certain disabilities and to low-income adults and their children. the federal medicaid act (fma) requires states participating in medicaid programs to provide medically necessary treatment to eligible children. under federal medicaid law , states must provide "early and periodic screening , diagnostics, and treatment," also known as epsdt services, to eligible medicaid recipients under age (u.s.c. § d(a)( )(b)). the defi nition of epsdt includes necessary health care , diagnostic services, treatment, and other measures described in the medical assistance subchapter for the united states code ( u.s.c. § d (a)) ( ) that correct or ameliorate defects and physical and mental illnesses and conditions discovered by the screening services, regardless of whether such services are covered under the state plan ( u.s.c. § d (r)( )) ( ). the medical necessity standard , which is based on clinical standards of care, refers to interventions that may be justifi ed as reasonable, necessary, or appropriate. states must comply with the fma standard to cover all treatments for a medicaideligible child's physical or mental condition, even if service coverage is optional for adults covered by medicaid. fma also bars states from arbitrarily denying or reducing the amount, duration, or scope of a required service to an otherwise eligible recipient solely because of the diagnosis, illness, or condition (nebraska legislature ). despite the provisions of fma, the u.s. department of health and human services, which oversees the medicaid program, excludes certain behavioral health treatments for children with developmental disabilities and autism (national health law program ; autism society of nebraska ). in addition, some states' medicaid contracts allow insurers more freedom than other states to deny payment for services. states also vary in who-the claimant or the insurer-must prove whether coverage provisions are adequate or fall short of federal medicaid legal standards (rosenbaum and teitelbaum ) . differences among states in approval of payment for specifi c treatments, including mental and behavioral health treatment, illustrate the need for more consistency in medicaid coverage provisions and the lack of parity between mental and physical health coverage. mental health benefi ts must be offered at parity with medical services to newly eligible recipients as part of the patient protection and affordable care act (aca), and medicaid expansion controversy is clear evidence that parity is a work in progress (mental health america ; u.s. department of labor ). because of inadequate coverage for mental and behavioral health services for medicaid-eligible children , some parents have no option other than to surrender their child to the child welfare system so that the child will receive full coverage for necessary mental and behavioral health care services. this results in signifi cant cost-shifting from medicaid to the state's child welfare system. that is, when a state provides federally mandated services to medicaid-eligible children, it receives a fi nancial match from the federal government to pay the cost s. when a state denies federally mandated medicaid services and a family surrenders a child to state custody so the child can receive care, the state pays the expense of the previously denied medicaid costs plus the expense of entitlements the child acquires as a ward of the state. the aca medicaid expansion offers a window of opportunity to increase coverage for behavioral health treatment for children with mental illnesses. although the federal government will bear the primary fi nancial burden of medicaid expansion, some states have elected, for political reasons, not to participate in this expansion. for participating states, aca medicaid expansion will replace state and local mental health services funds with federal medicaid money that will cover a wider range of home and community-based services for mental illness treatment (bazelon center for mental health law ). public health agencies and leaders often provide input for the medicaid system, helping to develop protocols, criteria, and rules about which treatments are defi ned as medically necessary . such decisions about medical necessity affect clinicians, patients, and families because they determine which treatments get recommended at the clinical level and infl uence which treatments insurers cover. you are the medicaid director of a state with the country's highest percentage of children in the child welfare system. twenty-fi ve percent of children in the state's foster care system are there not because of abuse or neglect, but because of behavioral problems and mental illnesses. as a state offi cial, you are aware that this results in signifi cant cost-shifting from medicaid to the state's child welfare system. recently, the case of -year-old sam has come to your attention. sam's family cannot afford mental and behavioral health care for sam, although he is medicaideligible and insured through magiscare (a private company with a state contract to administer medicaid for mental and behavioral health services). sam's parent s are considering surrendering their boy to become a state ward to get him the mental health services he needs. sam, you learn, eats random objects and dirt, throws tantrums, bangs his head on the ground, hits and bites himself and others, and often runs away. recently diagnosed by his physician as having autism, sam was referred to a psychologist who recommended outpatient behavioral therapy. both the physician and the psychologist expect this therapy to be covered through the family's magiscare plan. magiscare denied the psychologist's requests for payment on the grounds that, for children of sam's age, behavioral management is not covered under state law because it is not "medically necessary." magiscare substantiated their denial of payment because sam's behaviors primarily refl ect developmental disabilities related to autism, which are not covered under their contract with the state. when you ask the magiscare executive director about this case, she suggests that sam's parent s could attend therapy sessions to help them cope with their son's behaviors, but she reasserts that behavioral management is not covered for children as young as sam under state law because it is not medically necessary. members of the state legislature and child mental health advocacy groups are trying to expand access to home-based and community-based mental health services. they have asked you to support their efforts. you also consider that your governor, who is your boss, has publically stated his fi rm opposition to aca medicaid expansion, thus denying the state the opportunity to expand coverage for children's mental and behavioral health treatment through the aca. at present, you know that your state is offering limited mental and behavioral health service s and that narrow defi nitions of medical necessity are used to limit access to those services. as the state medicaid director, which steps should you take? . who are the main stakeholder s in this case, and what are their primary interests? . "passing" the expense of coverage denied by medicaid to other components of public service, such as the child welfare system, has fi scal and social implications. (a) what are some of these implications? (b) how should prevalence, mortality, disability, and cost be factored into thinking about ways to balance short-and long-term risk s and benefi ts to individuals and to the public in this case? . suppose a policy advisor warns that expanding behavioral health care for children will strain the medicaid budget and require cuts in services for adults or reduce their eligibility. (a) how should you respond? (b) which considerations or priorities would guide your funding allocations? . what role should ethical principle s such as stewardship , public health leadership , and moral courage play in this case? . medical necessity implies an acute care model of health service delivery and refl ects a clinical perspective. how well does this idea apply to a public health prevention model of health service delivery? are there better alternatives? . parity in insurance coverage for mental health is federally mandated for private insurers, which covers most citizens, but has proven to be an elusive goal for people who do not have private insurance or do not have enough coverage. medicaid is a public ( government funded) insurance program, not a private one. although medicaid benefi ciaries receive coverage for medically necessary mental health services, e ach state defi nes medical necessity uniquely. (a) should a federal mandate defi ne medical necessity for mental and behavioral services? (b) what fi nancial implications would such a mandate have from a state perspective and from an overall perspective? . the term principle-policy gap can be used to characterize situations in which most people support health coverage in principle ; but in practice, they are unable to pay for coverage or unwilling to take the political , social, cultural, or fi scal risk s necessary to enable such coverage. what do such gaps tell us about which value s the majority favors, and how might the term principle-policy gap help us understand the dynamics in this case? what roles should public health leaders play in responding to principle-policy gaps? public health systems are usually underfunded in comparison with health care systems. in fact, the organisation for economic co-operation and development (oecd) countries allocate on average only % of their health spending to pub lic health and prevention activities (oecd ) . this low funding of public health programs hinders the capacity to implement effective public health policies (robert wood johnson foundation ). population health challenges, such as infl uenza pandemics, are increasingly complex, and tackling them involves urgently executing a wide array of public health measures to prevent disease transmission. in the case of infl uenza pandemics, measures can vary from border quarantine, social distancing, provision of antivirals and vaccine s, and personal hygiene strategies. recommendations often need to be made quickly even when knowledge about the seriousness and potential health and social effects are incomplete. the target for preventive interventions is the entire population. however, resources for intense and sustained health campaigns through mass communications are expensive. in addition, the social determinants of the disease must be understood and considered (crowcroft and rosella ) . this typically involves the need for policies that engage the health and non-health sectors, such as educational policies and social or economic factors (savoia et al. ). this complexity, together with decreasing funds and other factors, has contributed to increasing private sector involvement in health care. according to the world health organization (who), a public-private partnership gathers a set of actors for the common goal of improving population health through agreed roles and principle s. this may also be described as public sector programs with private sector participation (who ). who has described several types of partnerships, including philanthropic, transactional, and transformational. sponsorship is a form of a public-private partnership defi ned as "any form of monetary or in-kind payment or contribution to an event, activity, or individual that directly or indirectly promotes a company's name, brand, products, or services" (kraak et al. ) . in this sense, sponsorship is a commercial transaction, not type of philanthropy. public-private partnerships have become increasingly common for public health campaigns. some transnational companies and their corporate foundations collaborate with public institutions, such as united nation s agencies and government s, to tackle complex public health problems, such as treatment of diarrhea in developing countries (torjesen ) , tuberculosis , and malaria (ridley et al. ) . these collaboration s have been encouraged by international institutions and experts as a way to mobilize resources and expertise, which could complement the public sector. who has also encouraged using public-private partnerships to deliver health services for a range of health problems, including hiv infection, malaria , tuberculosis , trachoma, and vaccine-preventable diseases (buse and walt a , b ) . however, corporations' increasing role in public health has been criticized as jeopardizing the mission of public health and its commitment to population health (hastings ; ludwig and nestle ) . some corporations have used tactics that discredit public health actions, such as distorting scientifi c information and using fi nancial tactics and political infl uence to avoid unfavorable regulations (wiist ) . public health profession als, public health agencies, and governments often must decide whether to collaborate with the private sector to improve population health. these decisions are increasingly frequent as health department budgets shrink and public-private partnerships are seen as a way to secure funds for core public health programs. ethical considerations can help us decide whether and when to form such partnerships. however, the available public health ethics frameworks (e.g., public health leadership society ; nuffi eld council on bioethics ; kass ) do not specifi cally discuss public-private partnerships. only the public health leadership society provides guidance for such collaborations. principle proposes that, "public health institutions and their employees should engage in collaborations and affi liations in ways that build the public's trust and the institution's effectiveness." continued discussion about the ethical implications of private-public partnerships is needed. top health offi cials in an industrialized country have declared a public health emergency due to an infl uenza pandemic. the head of the country's health department receives a call from the president of a multinational company that produces sugary, high-calorie drinks. the company president expresses his concern about the pandemic and wants to collaborate with the government to prevent the spread of fl u. the company offers the health department a considerable amount of space, onethird of each can, on its star product (a soft drink) free of charge, to include messages on fl u prevention . the company insists that the health department logo be included on the can along with the preventive messages. for them, the association between the health department (through the logo) and their product is essential for the collaboration as it would be an acknowledgement by the health department of the company's social responsibility. the head of the health department arranges a meeting with several health authorities and offi cials to consider the offer. on one side, some members of the group support the proposal because of the need to carry out far-reaching public health campaigns to limit the impact of pandemic fl u. at that stage, the incidence of pandemic fl u is increasing quickly and the number of new outbreaks in schools is worrying the health authorities and the population . there have been recent budget cuts to the health department, and some offi cials argue the company's contribution may be the best option to ensure a far-reaching campaign on prevention measures to benefi t the population. they see sponsorship as a form of social responsibility because the company does not have any apparent economic interest in fl u-related activities. they also note that there are no other companies offering a similar collaboration. but other offi cials say the company's soft drink products contribute to the obesity and diabetes epidemic and that the company's use of the health department logo would label it a pro-health industry with the backing of the highest health authority in the country. they also raise concerns about risking the independence of the health department in future regulatory action on sugar-rich beverages. as the hea d of the health department, you must decide if you should collaborate with the company. . what considerations should the health department director weigh when deciding whether to collaborate with the beverage company? . who are the major stakeholder s the health department should consider, and what value s might each of these stakeholders bring to this decision? . in making your decision, what values should be prioritized? . what positive or negative impacts would displaying the health department logo on the soft drink cans have on health department operations? . how might sponsorship by a company that produces sugary beverages affect public trust in the health department and the institution's effectiveness? . would the decision be different if the company produced healthy foods and the department's logo was placed on a healthy product? . would community involvement facilitate decision making and the consideration of the ethical questions? what ethical criteria or guidance should be established to accept or reject a future donations or sponsorship of a public health program by a company? preterm births, the leading cause of infant mortality, are increasing annually worldwide (world health organization ). the united state s shares company with nigeria, india, and brazil among the top ten countri es with the highest numbers of preterm births and ranks st among organisation for economic co-operation and development ( in , about infants died per live births. by , that number fell to . . during the last half of the twentieth century, the rate of black infant mortality dropped dramatically. in , black infant mortality was . deaths per live births compared with . deaths per live births among whites (mechanic ) . but by black infant mortality fell to . deaths per live births compared with . deaths per live births among whites. as these numbers show, both groups made signifi cant absolute gains, with blacks gaining more in absolute terms-a reduction of . for blacks and . for whites. yet, black infant mortality still remained about twice that of whites. these disparities have persisted in the twenty-fi rst century. in , non-hispanic black women experienced the highest rate of infant mortality, with . infant deaths per live births, while non-hispanic white women had a considerably lower rate, with . infant deaths per live births. citing a report from the national healthy start association, macdorman and mathews ( ) report that programmatic efforts to reduce disparities in black-white infant mortality have had some successes at local levels, but eliminating the disparities is diffi cult. the u.s. centers for disease control and prevention and the u.s. department of health and human services have prioritized both the elimination of health disparities and improvement in overall population health. these twin goals-one distributive, the other aggregative-are separate and sometimes confl ict (anand ) . increases in health disparities often accompany advances in aggregate gains in population health (mechanic ) . although this case is specifi c to the united state s, the dilemma is not. data show that signifi cant progress on child mortality has been made in many countries but that this overall success is often coupled with increased inequalities between advantaged and disadvantaged groups (chopra et al. ) . in china and india, for example, disparities in mortality persist between boys and girls younger than years, a function of entrenched gender discrimination (you et al. ) . these examples raise challenging questions about how ethically to assess such cases and set priorities for the allocation of scarce public health resources. you serve as the director for the local health department in a racially segregated urban city in the midwest with one of the greatest concentrations of african americans in the united states. the city has a long history of civil rights activism that led to protests and marches that ultimately empowered and mobilized black communities and organizations. your health department has a history of prioritizing maternal-child health and the elimination of black-white disparities in infant mortality in its programs, an investment of resources affi rmed by the city residents through the department's community outreach program and planning processes. chronic underfunding of public health, made worse by the economic downturn, has resulted in drastic and unprecedented reductions in the public health budget. in consultation with your staff and community board of health, you have raised the possibility of redirecting resources from maternal-child health into other programs based on a number of practical and ethical considerations. as with national statistics, the city has seen signifi cant declines in black infant mortality, even as blackwhite disparities remain. you note that although the maternal-child health programs are cost-effective, their impact on reducing black-white disparities seems to have stalled. other programs appear to meet targets more consistently. to help support these other programs, you note that allocating resources to more effective programs provides more "health" per dollar, thus meeting the utilitarian demand to maximize overall health, which many view as the primary goal of public health and health policy (powers and faden ) . in addition, although black-white disparities in infant mortality persist, blacks have made signifi cant gains, declining more than whites in some decades. you note that remaining inequalities could be deemed ethically acceptable by some standard s of equity , such as the "maximin" principle . although this distributive principle is subject to interpretation (van parijs ) , it is generally understood to require that social and economic inequalities work to benefi t society's least advantaged groups. thus, inequalities (even signifi cant ones) are morally acceptable as long as the least advantaged have signifi cantly benefi ted (powers and faden ) . the director of community outreach proposes that the health department not make this decision unilaterally, but instead listen to community opinions on these questions of priorities and fairness. he suggests that the health department collaborate with community partners to host a series of public forums. he insists that a topic of such historic and contemporary concern to the community must be subject to public deliberation. despite having a history of supporting community discussions, you are concerned about the cost of community forums, noting that they will drain resources from an already slim budget. the chilean sy stem of guarantees in health-created by law in -aims to establish guaranteed health care interventions in health promotion, disease and injury prevention , diagnosis and treatment , rehabilitation and palliative care (ministerio de salud ) . the law mandates that public and private insurers provide the resources needed to protect the public against excessive health-related spending and guarantee timely and universal access to authorized interventions based on standard s of care. national health objectives, established by the ministry of health, determine the list of guaranteed interventions. this list, however, is reviewed every years and amended as new scientifi c and health information emerges. as of , the system o f guarantees in health included interventions for health-related conditions (ministerio de salud ), accounting for almost % of the chilean burden of disease. the system of guarantees in health is a priority system based on acknowledged criteria, namely scientifi c evidence and socially shared value s. for the system to be effective, the criteria must be transparent, publicly accepted, and open to review and modifi cation. the law that created the system of guarantees in health also mandated a procedure for selecting the guaranteed interventions (ministerio de salud ) . the procedure factors in public opinion research to identify social consensus on health priorities, studies to identify effective interventions that prolong and improve quality of life, and assessments of interventions' cost effectiveness (burrows ). the procedure determines priorities with an algorithm that includes these factors and information on disease burden and health system capacity (missoni and solimano ) . after choosing the health interventions, the health ministry elaborates on a package of interventions related to specifi c health conditions and develops clinical guide lines for such interventions. you direct a team within the ministry of health that is responsible for recommending priorities for guaranteed health interventions. the priority ranking system emphasizes the selection of cost-effective interventions for conditions with the greatest burden. however, the health ministry also has authorized including expensive interventions that are less effective or treating health conditions with low prevalence, if that condition or those interventions signifi cantly impact health. because of budget reductions, a number of interventions are under review. your team has been asked to recommend funding interventions for two health conditions-cataract (a common condition with highly effective treatment ) and multiple sclerosis (a less prevalent condition but one with signifi cant health and social impact). cataract, the main cause of blindness, primarily affects people over . this health problem has a high impact as measured by quality-adjusted life years (qalys) (ministerio de salud ) . its surgical treatment is effective for - % of patients. the package of guaranteed interventions includes diagnostic confi rmation within days after suspected diagnosis and surgical treatment days after confi rmation. in , it was expected that , cataract surgeries would be performed in chilean public hospitals and in private institutions. multiple sclerosis , an autoimmune infl ammatory disease leading to demyelination in the central nervous system, produces a progressive deterioration of health and quality of life. it represents a minimal disease burden at the population level, mainly due to premature death. in chile, it is estimated that patients are treated for multiple sclerosis each year. the package of guaranteed interventions includes diagnostic confi rmation within days; confi rmed cases must receive treatment within days. treatment includes pharmacological therapy and p hysiotherapy. contingency arrangements. to make the best use of resources and personnel (even in the absence of a pandemic), patients are triaged-evaluated to determine the type and priority of care to be received. while medical information informs the development of triage criteria, ethical considerations about triage goals-whether explicit or implicit-also play a role. for public health emergencies that overwhelm capacity, some propose adjusting critical care triage criteria to emphasize certain public health goals, like saving the most lives possible (christian et al. ; silva et al. ) . some contend that utilitarian reasoning should predominate in critical care triage, based on the intuition that, when resources are scarce, allocation decisions should produce the greatest good for the greatest number (charlesworth ; childress ) . critics of utilitariani sm reply that it requires coercion or covertness to succeed, because the public will not voluntarily sacrifi ce their lives or their loved ones for the greater good (baker and strosberg ). utilitarian triage may be unpalatable to the public on the further ground that it quantifi es and judges the value of one life over another, which could disproportionally impact particular population groups (hoffman ). others therefore would base triage decisions on egalitarian considerations, for instance, by giving everyone an equal chance at obtaining a scarce good, an approach for which historical precedent exists (baker and strosberg ) . whatever approach is adopted, prior arrangements between policy makers, practitioners, and the public based on thoughtful, transparent deliberation about the most ethical approach to ccu triage usually will improve the legitimacy of d ecisions. those who promote an approach based on fairness and equity need to consider that, during public health emergencies, the goal of saving lives may force a retreat to utilitarian ethics (kirkwood ; veatch ) . while not necessarily unethical in itself, a retreat that overturns prior arrangements lays itself open to charges of illegitimacy. variability in the frameworks used to allocate public health resources illustrates the importance of refl ecting upon the value s that undergird policy decisions and individual practices, like critical care triage. appealing spontaneously in the heat of the moment to values that have not been adequately refl ected upon or discussed in a transparent and deliberative manner may lead to undesirable outcomes and accusations of unethical practices. while discussions of ccu triage criteria ultimately concern institutional clinical policy and practice, they refl ect a larger discussion about the overarching public health goals in the face of large-scale, widespread public health emergencies, like pandemics. an outbreak of a novel infl uenza virus has progressed to the point that the world health organization has declared a pandemic. in the pandemic's fi rst wave, hospital capacities were suffi cient to handle the infl ux of pandemic infl uenza patients, whose morbidity and mortality rates mirrored rates for seasonal infl uenza. however, despite a vaccination campaign and other measures, such as ensuring surge capacity, rates of morbidity and mortality associated with the virus have increased drastically during the pandemic's second wave. the resulting increased number of patients needing hospital beds has overwhelmed even the surge capacity of the ccus of a metropolitan city's tertiary care hospitals. to meet this challenge, a teleconference has been scheduled between several members of the hospitals' administration, the ccu directors from each hospital, and public health offi cials involved in leading the jurisdiction's pandemic response. as a public health offi cial who played a central role in developing the pandemic plan for your jurisdiction, you have been included on the call to provide guidance for the pandemic response. during the meeting, a number of ccu directors report that their physicians and nurses are concerned about the type of patients bein g admitted into the ccu. some of the directors see a trend that they suggest is ultimately undermining the effi ciency of the pandemic response. they argue that, as the severity of the pandemic continues to increase, their triage criteria should be modifi ed so as to use ccu resources to save the most lives possible. they worry that admitting those who present with the most need is preventing treatment of those who will benefi t most from ccu admission. "so long as our triage scheme saves the most lives, it is ethically justifiable" a number of them declare. the group takes up the proposal of a ccu director to triage according to sequential organ failure assessment (sofa) scores-which are derived using a tool that determines a patient's organ function and failure rate to predict outcomes (vincent et al. ) . were the pandemic's severity to increase, the group suggests that, in addition to the ccu director's proposal to use sofa criteria, even more inclusion, exclusion, and priority criteria could be added with the goal of saving as many lives as possible. they've proposed exclusion criteria for ccu admittance that include patients with a poor prognosis, patients with other known health issues, and some mention of age cut-offs, to name a few. others involved in the teleconference question whether this is the right approach to take. they argue that, by aiming to save the most lives possible, those who may benefi t less from ccu admission, like older adults or individuals with disabilities, will be unfairly affected. they say, "we should not just aim to save lives, but rather save lives fairly ." as you and your public health colleagues are leading the pandemic response, the hospital administrators and ccu di rectors look to you for a recommendation or decision about how to proceed. . ensuring that the ccu has surge capacity is a common strategy to accommodate an infl ux of patients who have been infected with pandemic infl uenza. (a) does surge capability require alternative critical care triage criteria? (b) if the population's health needs exceed contingency arrangements, should alternative critical care triage criteria be used? (c) how should these decisions be made? (d) what principles, value s, or processes should infl uence these decisions? . what considerations might exist during a pandemic that do not exist in everyday critical care and critical care triage that do or do not support the modifi cation of triage criteria? if pandemic critical care triage requires a unique conceptual framework, what principles ought to be valued in such a framework (e.g. need, equality, utility, effi ciency)? . would the severity of a pandemic ever warrant the use of a utilitarian scheme for critical care triage, given that the public generally fi nds it unpalatable and carrying out such a plan could require coercion? how could an adverse public reaction to coercive or covert measures be mitigated? . in a pandemic, the most seriously ill patients with the lowest probability of being saved might be left untreated because their care would require too many resources with little prospect of recovery. this illustrates a confl ict between the common good and the best interests of individual patients. what other confl icts might arise when triaging in a pandemic? . triage can be used to maximize the number of lives saved with available resources. should we aim to maximize the number of lives or, alternatively, the number of life years saved? this can also give rise to questions about the quality of those lives and years lived. is it ever appropriate to make allocation decisions based on quality of life or life years? ethical issues in recipient selection for organ transplantation priority to the worst off in health care resource prioritization ethical issues in the use of cost effectiveness analysis for the prioritization of health care resources the effi ciency frontier approach to economic evaluation of health-care interventions rationing fairly: programmatic considerations how to achieve fair distribution of arts in " by ": fair process and legitimacy in patient selection just health: meeting health needs fairly setting limits fairly: learning to 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health? is there an obligation for health systems to cover all health problems affecting a population? are there limits? how should health problems be prioritized and who should have the authority to make these decisions? which criteria should receive the most weight in ranking priorities? how should resources be distributed among health conditions affecting many people versus health conditions affecting few people? how should resources be distributed among procedures that are preventive versus treatments for existing conditions? how does taking a public health perspective versus a clinical medicine perspective affect your thinking about including these two conditions in the system of guarantees in health? what role should transparency play in the selection procedure? references burrows establece un régimen general de garantías en salud estudio carga enfermedad y carga atribuible decreto supremo no. . aprueba garantías explícitas en salud del régimen general de garantías en salud 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addressing ethical issues in pandemic infl uenza planning: discussion papers the authors thank student chelsea williams for her assistance in assembling the facts of the case. we also thank creighton university's center for health policy & ethics. acknowledgements we thank mr. jonathan whitehead for language editing. open access this chapter is distributed under the terms of the creative commons attribution-noncommercial . license ( http://creativecommons.org/licenses/by-nc/ . / ) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. the images or other third party material in this chapter are included in the work's creative commons license, unless indicated otherwise in the credit line; if such material is not included in the work's creative commons license and the respective action is not permitted by statutory regulation, users will need to obtain permission from the license holder to duplicate, adapt or reproduce the material. this case is presented for instructional purposes only. the ideas and opinions expressed are the authors' own. the case is not meant to refl ect the offi cial position, views, or policies of the editors, the editors' host institutions, or the authors' host institutions. infectious diseases such as pandemic infl uenza and severe acute respiratory syndrome (sars) have attuned the attention of policy makers and health practitioners to the importance of protecting and promoting the public's health in the face of increased care needs and extreme resource scarcity. in particular, acute care needs for the critically ill and discussions of treatment priorities have been the subject of much debate in pandemic planning (hick et al. ; melnychuk and kenny ; uscher-pines et al. ). this is not surprising, as it has been estimated that more than , americans may require mechanical ventilation during a pandemic, far outnumbering available ventilators (rubinson et al. ; u.s. department of health and human services ) . additionally, shortages of hospital beds, personnel, and other equipment can be expected during a pandemic, which may limit the ability to meet an expected increase in patient volu me (world health organization ).prudentially planning for the public's increased care needs during a pandemic requires assessing surge capacity, especially in critical care units (ccu). however, as pandemics increase in severity, they can overwhelm critical care capacity and key: cord- -r e t c authors: de rooij, doret; rebel, rebekka; raab, jörg; hadjichristodoulou, christos; belfroid, evelien; timen, aura title: development of a competency profile for professionals involved in infectious disease preparedness and response in the air transport public health sector date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: r e t c background: recent infectious disease outbreaks highlight the importance of competent professionals with expertise on public health preparedness and response at airports. the availability of a competency profile for this workforce supports efficient education and training. although competency profiles for infectious disease control professionals are available, none addresses the complex airport environment. therefore, the main aim of this study is to develop a competency profile for professionals involved in infectious disease preparedness and response at airports in order to stimulate and direct further education and training. methods: we developed the competency profile through the following steps: ) extraction of competencies from relevant literature, ) assessment of the profile in a national rand modified delphi study with an interdisciplinary expert group (n = ) and ) assessment of the profile in an international rand modified delphi study with an airport infectious disease management panel of ten european countries (n = ). results: we systematically studied two competency profiles on infectious disease control and three air transport guidelines on event management, and extracted relevant competencies for airports. the two rand modified delphi procedures further refined the profile, mainly by specifying a competency’s target group, the organizational level it should be present on, and the exact actions that should be mastered. the final profile, consisting of competencies, covers the whole process from infectious disease preparedness, through the response phase and the recovery at airports. conclusion: we designed a profile to support training and exercising the multidisciplinary group of professionals in infectious disease management in the airport setting, and which is ready for use in practice. the many adaptations and adjustments that were needed to develop this profile out of existing profiles and air transport guidelines suggest that other setting-specific profiles in infectious disease control are desirable. a a a a a to the best of our knowledge, there is currently no profile that describes the competencies that professionals involved in infectious disease management at airports need. therefore, this study aimed to develop such a profile that describes the competencies that a multidisciplinary group need-in addition to the basic knowledge and skills required for their profession-when called upon to prepare and respond to infectious diseases in the airport environment. we performed the systematic rand modified delphi consensus procedure [ ] to develop a competency profile for professionals involved in infectious disease preparedness and response at airports. competencies were extracted from existing competency profiles and air transport guidelines on event management and consecutively presented to a national and an international panel of professionals. both panels followed a methodologically identical path (fig ) that consisted of two rounds of data collection. first, panels assessed the relevance of competencies regarding their expertise during a digital questionnaire. next, consensus meetings were held to gather consensus on undecided competencies. the refined final competency profile based on the first national round formed the concept competency profile for the international validation. this method is commonly used for the development of competency profiles [ ] , using the collective subjective judgment of professionals [ ] . step and were performed twice in this study: first with a national expert panel and after with an international expert panel. the study population of the national panel consisted of professionals involved in infectious disease preparedness and response at schiphol airport. this airport is the only ihr designated airport in the netherlands, one of europe's largest airports and a major hub in international air traffic [ ] . the study population of the international panel consisted of professionals involved at a local or national level in infectious disease preparedness and response at major european airports. the research team aimed for two panels consisting out of - participants [ ] , resulting in a national panel of and international panel of participants. in this way, we tried to assure both enough reflection of different opinions and a setting for a safe and fruitful discussion. the panels were recruited using purposive sampling according to inclusion criteria until a representative panel was composed or time was limited for further inclusions. the research team composed an invitation letter by e-mail explaining the background, aim, and method of the study for both panels, through which professionals could confirm their participation. for the national panel, we consulted an experienced nurse from the public health service at schiphol airport to discuss our sample. we invited experienced professionals for the national round from the following disciplines: international medical advice, airport medical services, public health service, air traffic control, flow management of aircrafts and passengers, airport fire officer, continuity & crisis management, and the disaster medicine organization. international medical advice, airport medical services, and the public health service collaboratively ensure that the infectious disease policy is feasible and effective at the airport. the public health service is responsible for the public health response. at their request, international medical advice facilitates medical items on board, such as personal protective equipment, and debrief crew and ground staff of an affected aircraft. in the situation that medical care is required, the ambulance will assist passengers upon arrival. professionals from air traffic control receive warnings from the pilot in command of a possibly affected aircraft and are responsible for informing the flow management of aircrafts and passengers which adjusts logistical processes at the airport. the airport fire officer ensures coordination among various emergency services during the management of an infectious disease case. the continuity & crisis management is responsible for advising on risk, crisis, and physical safety management. disaster management organization provides training in the field of infectious disease control at the airport. the international panel was recruited by selecting professionals who participated in a european, face-to-face -day training course on infectious disease control at designated airports. this course was part of the european union (eu) joint action healthy gateways [ ] and took place on - september in belgrade, serbia. we used these professionals' selfdeclared competence on local and national level before the training to approach a variety of professionals. on the local level, a functional distinction was made between competence in preparedness planning, decision making, and implementation. we invited professionals in all competence areas and tried to include one participant per country, with countries geographically divided over europe. step -literature search and extraction of competencies. we performed a literature search to identify competency profiles and air transport guidelines on event management. the search was executed in the th week of march using pubmed and google scholar. for competency profiles, search terms were 'infectious diseases' or 'public health', and 'competency' and their synonyms. for the airport guidelines, search terms were 'infectious diseases' or 'emergency preparedness' or 'public health event', together with 'airport' or 'air travel' or 'points of entry'. in pubmed, the search terms were limited to the title or abstract. in google scholar, we searched several combinations of search terms and screened the results until hits in a row were irrelevant. the search terms, the search strategy, the screening, and application of the selection criteria are shown in s file. regarding the competency profiles, the criteria for title/abstract screening were whether studies aimed at presenting competencies, and were aimed at infectious disease preparedness or control. inclusion criteria for the full-text screening of the competency profiles were the explicit presentation of a competency set in the study, competencies aimed at graduate level or professionals in practice, applicable to infectious disease management. further criteria to select the landmark studies contained a full array of competencies, being a peer-reviewed study, and being relevant for the airport setting. regarding the airport guidelines, the criteria for title/abstract screening were documents describing infectious disease management in the air travel setting with a disease-generic approach. the full-text screening inclusion criteria were documents aimed for the airport or air travel setting, prescribing infectious disease management in terms of specific preparedness and response tasks, with a disease a-specific approach. further selection was made based on the target group at airport level, whether unique topics were prescribed compared with other included studies, and presenting a full array of the preparedness and response process. the competency profiles and air transport guidelines were matched to develop a concept competency profile, using the following steps. first, we extracted main tasks for infectious disease preparedness and control from the guidelines that cover infectious disease management at airports during preparedness, response, and recovery. then, the competency profiles and air transport guidelines were independently reviewed by two researchers (ddr & rr) to extract competencies or textual fragments that could be reformulated into a competency, and which were relevant for a task. results were compared and dissimilarities were discussed until consensus was reached. subsequently, a data reduction round took place by applying three specifying criteria. first, we further narrowed the scope to the airport environment itself instead of competencies required regionally or countrywide. in addition, we restricted competencies on hygiene to the commanding level and excluded all operational cleaning. lastly, competencies or textual fragments regarding general team competencies were excluded in the profile because the team resource management (trm) skill set is already available and includes these [ ] . the trm skill set, developed for aviation safety, covers skills such as interpersonal communication, leadership and decision making, and is complementary to our competency profile. finally, we combined overlapping or congruent competencies and fragments. the included textual fragments were reformulated into competencies according to bloom's taxonomy of education objectives [ ] . data reduction was performed by rr & ddr collaboratively, all doubts and several versions of the draft profile were discussed with other researchers (eb and at). next to specifying competencies to a task, we also specified them to a role to further enhance the logical structure and the usability of the profile. for this purpose, we adapted the canmeds roles [ ] , which are widely used in medical education, into the following roles required in infectious disease management: ( ) health expert, ( ) organizer (including policy development), ( ) scholar. roles with respect to the communicator, professional and collaborator are required in general, and are, therefore, considered general tasks. during several discussion meetings with a third researcher (at), competencies were divided over tasks and roles and overlapping competencies were removed. this first step resulted in a concept competency profile. step -the national panel: digital questionnaire & consensus meeting. the next step contained the assessment of the draft competency profile in the national panel. a digital questionnaire was built in the web-based program formdesk [ ] . it was successfully pilot-tested on comprehensibility and usability by an experienced medical trainer working at the national institute for public health and the environment, and a physician specialized in infectious diseases from the maastricht aachen airport. the digital questionnaire started with information regarding the aim and process of the study and key definitions. also, participants received supportive documents on formulating competencies, according to bloom's taxonomy of educational objectives [ ] . in addition, a privacy statement was included. the first questions were related to demographic characteristics, such as their gender, profession, the number of years in their current profession, and their experience with infectious disease preparedness and response at the airport on a -point likert scale ( = very inexperienced, = very experienced). we requested e-mail addresses for planning the consensus meeting. subsequently, the relevance of competencies in the concept competency profile was graded by the participants using the following question: 'to what extent do you consider this competency as a relevant element for infectious disease preparedness and response at airports'? scoring was done using a -point likert scale ( = totally irrelevant, = totally relevant). the introduction, privacy statement, and demographic questions were in dutch, but the questions regarding the relevance of competencies, as well as the competencies were in english. all questions on relevance were mandatory. participants could comment on individual competencies as well as suggest new ones per category. after grading each competency, participants were asked if the competency profile reflected their knowledge, skill, and attitude regarding infectious disease preparedness and response at the airport. data were collected in the three weeks following may . participants who completed the digital questionnaire were invited to the consensus meeting. participants received a personal feedback report in advance of the meeting. this report showed the group ratings of each competency, together with the participants' individual ratings. participants could therefore identify major dissimilarities within ratings beforehand. the purpose of the meeting was to reach consensus by discussing these dissimilarities face to face. the moderator asked all participants to keep an incident in mind while considering the relevance of each competency. first, uncertain competencies were discussed, then competencies proposed by participants themselves, and lastly the suggestions for the reformulations of relevant competencies. if the participants could not reach consensus, a voting round was held to either accept, textually amend or reject the competency based on the majority opinion. after discussing all competencies, participants were asked whether the refined final competency profile reflected their knowledge, skills and attitude. finally, the usability level of this profile was discussed, including any further suggestions for improvement. the national meeting was in dutch because this was the native language of all participants. the meeting took place on june at the training center of schiphol airport. an experienced moderator (at) led the discussion. step -international validation: digital questionnaire & consensus meeting. the competency profile from step functioned as the starting point for international validation. the competencies were already stated in english, but we had to translate the introduction, statements, and demographic questions into english. we asked the respondents in the introduction to keep a recent incident or outbreak in mind during the completion of the questionnaire and asked them to specify which event this was. we added numbers to the tasks to manage expectations on the size of the competency list during completion, and added a suggestion for additional competencies on data protection and privacy. except from these changes, this international study was methodologically identical to the national study. the participants were invited on august and were reminded twice by e-mail after two and four weeks. the data collection through the questionnaire ended on september . the consensus meeting took place on september in belgrade, serbia, and was moderated by an experienced moderator. data from formdesk was transferred to an excel file and checked on irregularities. first, a descriptive analysis of demographic characteristics was performed. secondly, the median rating and the amount of dispersion of ratings between participants were calculated for each competency. if the competency had a median within - range and � % of the participants scored it in the top tertile (score , or ), then the competency was marked as 'accepted'. if the competency had a median of < and < % scored in the top tertile, then the competency was marked as 'not accepted' and excluded. if the median score laid between - and < % of the participants scored in the top tertile, then the competency was marked as 'uncertain'. in the national study, competencies with scores spread over all tertiles, despite any median, were also classified as 'uncertain'. table shows the classification of the competencies by the participants' median score and level of agreement. as the digital questionnaire contained openended questions and formulated competencies by the participants, responses were grouped and coded accordingly. to support the reliability, two researchers (ddr & rr) performed the data analysis independently and compared their results. the consensus meetings were audio-taped and in outline transcribed. a distinction was made between individual opinions and contributions to the group consensus. in accordance with the general data protection regulation, no names were used in the transcript. each participant received his or her own code, making it visible which recordings belong to the same professional. the codes of each participant were kept confidential and were only accessible to two researchers (rr and ddr). two researchers (rr and ddr) performed the data coding and analysis of the consensus meeting independently. the researchers discussed dissimilarities until consensus was reached. after the analysis of the international consensus round, an official translator reviewed the competency profile on use of language. the study protocol (lci- ) was reviewed by the clinical expertise centre of the national institute for public health and the environment. based on this review, they determined that the research plan did not fall under the scope of the dutch law on medical research involving humans. all necessary precautions were taken to protect the anonymity and confidentially of the participants; in the invitation letter, participants were informed about their voluntary participation and informed that they were free to decline at any time. furthermore, the participants were informed that their responses were processed anonymously and only used for research purposes. the literature search for competency profiles resulted in unique studies included in titleand abstract screening, and studies included in the full-text screening, of which two had the highest applicability and were therefore selected. these profiles were aspher's european list of core competences for the public health professional [ ] and public health emergency preparedness-core competencies for the eu member states [ ] . the competency profile for infectious disease management at airports the literature search for airport guidelines resulted in unique documents. nine were included during the full text screening. three guidelines had the highest applicability and were therefore selected, being the handbook for the management of public health events in air transport [ ] , coordinated public health surveillance between points of entry and national health surveillance systems [ ] and the guide for public health emergency contingency planning at designated points of entry [ ] . during data extraction, fifteen tasks and competencies were selected from the source documents. after data reduction, around competencies and exactly eleven tasks were left. aggregating double competencies resulted in competencies which originated from existing competency profiles and from reformulated textual fragments from the air transport guidelines. as a result, the concept competency profile consisted of competencies divided over eleven tasks ( thirty professionals were approached for the national study by e-mail. ten were approached personally; professionals from the afo and ams were approached as a group (n = ). professionals from phs, ima, ams, aas, and dmo agreed to participate, professionals from atc, afo, and fma could not participate in the study due to time constraints. however, one participant from aas had previously worked at the afo and voluntarily stated as a note in the questionnaire to keep this experience with afo in mind while filling in the questionnaire. nine out of ten included participants that completed the questionnaire had extensive experience in infectious disease preparedness and response at schiphol airport. the input from the dmo participant was not included in the analyses since she pointed out in an e-mail to the researchers that she is solely involved in the organization of training courses and therefore unable to grade the competencies in terms of relevance. sixteen professionals from thirteen countries were approached for the international study, of which ten from ten countries (austria, cyprus, germany, italy, ireland, malta, slovenia, spain, switzerland, and poland) accepted to participate and completed the questionnaire. nine professionals (from austria, cyprus, germany, italy, ireland, slovenia, spain, switzerland, and poland) attended the consensus meeting. their self-assessed competence areas were equally represented among professionals with most representing more than one area: six from the ten professionals were involved in preparedness planning, six in decision making and six in implementation of measures at the airport level. on the national level, five of ten participants were involved with preparedness planning. table shows the demographic characteristics of the included participants. the first questionnaire round resulted in "accepted" competencies, "irrelevant" competencies, and competencies that were marked as "uncertain" (fig ) . participants provided three main reasons for their low grading of relevance: ( ) not relevant to all professionals; ( ) concerning individual risks and not aimed at public health; ( ) out of scope, primarily focused on other areas (e.g., laboratories). the inconsistency in relevance scores of uncertain competencies reflected different professions. the participants proposed additional competencies. three participants confirmed, five partly, and one denied that the competency profile reflected their competencies in infectious disease preparedness and response at airports. no irregularities were found within the data analysis. five of nine participants attended the consensus meeting. the participants from dmo, ams, and one from aas could not attend the meeting due to time constraints. the"uncertain" competencies were discussed of which three were excluded, ten were included after textual amendment, and five were included without textual amendment. textual amendments included adjusting the target group described within the competency or adapting a verb from an executive to an advisory focus. of the suggestions for additional competencies, three were included. these included competencies entailed the understanding of the logistical structure and functioning of airports, implementing contact tracing, and contacting professionals with extensive epidemiological knowledge for outbreak investigation. ten competencies that were already included were reformulated. the group reached consensus for all competencies, no voting rounds were initiated. the reflection after the consensus meeting resulted in several the competency profile for infectious disease management at airports strengths and difficulties of the profile. during the national study, participants stated that they had enjoyed discussing the profile and this had improved their understanding of roles and responsibilities of different professions involved. several participants involved in design and organization of training and exercises would use the profile either to derive training goals or as a background document for participants. suggestions for improvements were to design a better manageable length or more practical format of the profile, either by splitting it for different disciplines, or connecting competencies to specific tasks. one participant indicated that the content of the competencies had become more evident after the meeting ( table ). the questionnaire round with the international panel resulted in "accepted" competencies, seven that were marked as "uncertain", and one "irrelevant" competency. the excluded competency entailed balancing costs and results during ph response. the inconsistency in relevance scores of uncertain competencies reflected different professions. the participants proposed twelve additional competencies. seven participants confirmed, and three partly confirmed that the competency profile reflected their competencies in infectious disease disaster medicine organization (dmo) airport level-ph decision making airport level-ph preparedness planning airport level-ph measure implementation national level-ph preparedness planning the competency profile for infectious disease management at airports preparedness and response at airports. no irregularities were found within the data analysis. six of the ten participants stated to have imagined a case during completion of the questionnaire, of which all referred to evd or viral hemorrhagic fevers in general. other named diseases were seasonal influenza, tuberculosis and measles. nine out of ten participants attended the consensus meeting. during discussion of the first competency, the group initiated a voting procedure which was used during the majority of competencies. the"uncertain" competencies were discussed, of which three competencies for surveillance and risk assessment were excluded because they were not considered as tasks at the local level. three competencies were included without textual amendments, and one after further specification of the target group. the only excluded competency in the questionnaire round-on taking the costs in consideration during ph response-was decided yet to be the competency profile for infectious disease management at airports included. of the twelve suggestions for additional competencies, four were added to other existing competencies, five were declined, and three were included. these included competencies entailed knowledge of specific terminology in use, data management, and network management of key partners to assure rapid response and recovery. analysis of the discussions during and after the consensus meeting indicated that people had sometimes doubted the relevancy of certain competencies due to difference between their own functional level and the scope of the profile (airport level). also, the differences between several countries in the division of tasks and responsibilities became clear. participants would use this profile as a source for training goals at the airport or as a background document during training ( table ) . to enhance the profile in any kind, they suggested to use the profile during a future training or exercise or to discuss it with their entire team at a local airport. the final competency profile (table ) consisted of competencies that were categorized into eleven tasks: communication (c = ), collaboration (c = ), professionalism (c = ), training (c = ), contingency planning (c = ), surveillance (c = ), risk assessment (c = ), outbreak investigation (c = ), management of ill / exposed travelers (c = ), public health measures (c = ), and evaluation and recovery (c = ). the majority of competencies entailed the roles of the health expert (c = ) or organizer (c = ). four competencies involved the scholar who is needed during outbreak investigation and implementation of health measures. in this study, we developed and validated a competency profile for professionals involved in infectious disease preparedness and response at airports. to the best of our knowledge, this is the first systematically developed competency profile describing the competencies for the air travel environment. the multidisciplinary consensus procedure ensures coverage of all major aspects of preparedness, response and recovery; the international consensus procedure with experts from various countries provides content and face validity to the competency profile and increases its potential for international application. a setting-specific profile is required because of the specific requirements according to international regulations [ ] , and the numerous actors which are involved from a range of sectors "i would use it as a source of competencies that you like to address in a training or exercise or anything like that. so, if you are running a table top or live exercise at the airport, these are the aspirational competencies that you would like, not only for the public health staff but for the whole response." "i really like it actually that you make this profile especially for the point of entry. i have never seen anything like this before but it is really nice. i consider it to be a good reflection of someone being responsible for working directly and being involved in public health measures at the airport." pha = public health authority at the airport; ima = international medical advice; md = medical doctor; f = female; m = male. https://doi.org/ . /journal.pone. .t the competency profile for infectious disease management at airports table . competency profile for professionals involved in infectious disease preparedness and response at airports. communicator • understand and implement the basic principles of risk communication to airport and airline staff, travelers, the public and media. • establish trust with airport and airline staff, travelers, the public and media by using rapid communication channels and ongoing two-way communication. • understand the terminology used by different levels and organizations at the airport. professional • minimize the discomfort or distress associated with public health measures experienced by crewmembers, ground staff, and passengers. • apply relevant laws to data collection, storage, management, dissemination and use of information. • understand the importance of multidisciplinary collaboration during acute outbreak management. • be an effective team member, adopting the role necessary to contribute constructively to the accomplishment of tasks by the group. • participate in the implementation of established plans which ensure the continuity of operations. • create and manage a network of key partners in rapid response and recovery. health expert • provide training and exercises on communication within, and between, involved airport organizations and include healthcare providers in this training. • identify training needs, and plan and organize courses. • periodically practice and test the ability to make decisions in unpredictable circumstances. health expert • be familiar with job-related standards and recommended practices concerning infectious disease control of national and international aviation organizations (iata, icao and capsca). • periodically assess whether the implementation of strategies, standard operating procedures (sops) and action plans requires any changes. • before the response operation, identify which triggers will require key decisions to be made during the outbreak response (keeping in mind that triggers may need modification to fit specific situations). • before the response operation, plan for the storage and stockpiling of medical and non-medical countermeasures. • understand the logistical structure of the airport and the international context of airports and their functioning. • identify key partners and develop a common understanding of roles, resources, planning assumptions, risks or vulnerabilities, and information needs. • support core-capacity-building at the airport and understand the importance of it. • develop, test and evaluate a public health emergency contingency plan (phecp) on a periodical basis. • provide healthcare workers with clinical guidelines for emerging infections from abroad, especially those that may be carried by travelers and the severely contagious. health expert • recognize a potentially infectious disease by key symptoms and signs of events among travelers. • understand the relevance of early detection of public health threats. • understand the components of surveillance systems and how these work. • understand the roles and responsibilities of local, national and international organizations involved in infectious disease control. • be familiar with laws on the surveillance and reporting of infectious diseases at national, european union level and globally (international health regulations). (continued ) health expert • understand risk analysis frameworks, with the elements of risk assessment, risk management and risk communication. • determine when a risk assessment should be carried out, and appropriate measures taken. • perform a risk assessment and continuously review the risk assessment as further information becomes available. • interpret the diagnostic and epidemiological significance of laboratory tests reports. • collect and integrate the facts of an event, based on information from multiple sources, including the traveler, the aircraft operator, ground-based medical services for aircraft in flight (when available) or the agent responsible for the baggage or cargo. • know when case reports or clusters require further investigation, and how to initiate such investigations. health expert • conduct outbreak investigations to identify pathogens and other agents, characterize affected population groups, and sources of exposure. • use reliable systems for disseminating case definitions to standardize both the diagnosis and the reporting of case numbers (e.g. confirmed, suspected, probable, or possible, cases). • systematically generate required information about the number of travelers such as those targeted for screening, screened, referred to secondary screening, and identified as confirmed cases. • implement contact-tracing based on a careful, case-by-case, risk assessment basis, taking into account factors such as feasibility, the severity of the disease and its potential for epidemic spread, the infectivity of index patients, and the duration of the trip. • identify who is responsible at national level for receiving the information on the investigation from the local or intermediate level health authority. • maintain up-to-date and job-specific knowledge about characteristics of infectious diseases such as the reservoir, potential sources, modes of transmission, risk groups, and duration. • be able to contact professionals who have the biological, clinical, and epidemiological knowledge necessary to characterize (potentially novel) pathogens and other agents responsible for an outbreak disease. • use evidence-based methods to identify and recommend control and preventive measures to control an outbreak. health expert • provide ground-based medical support (gbms) regarding infectious disease events, including medical recommendations to manage the discovery of a suspected communicable disease during flights, to support decisions regarding medical treatment and use of on-board medications or equipment. • assess the health status and travel history of travelers arriving from, or going to, an affected region, or who have been exposed to a potential public health risk during air travel. • provide disembarking travelers with information regarding the precautions to take in the event of illness, information sources for any updates on the event and the public health authority (pha) contact information where subsequent enquiries can be made. • provide advice concerning the appropriate parking stand for an incoming affected aircraft and the order of disembarkation of passengers. • provide advice to ensure port health staff respond efficiently so as reduce the time that travelers spend on a board-affected aircraft, and identify space requirements for interviews and health assessments of arriving travelers. • provide advice on a traveler's possible transfer to a medical facility by ambulance and facilitate the rapid transport of suspected cases of an infectious disease. other than public health [ ] . as such, airports function as coherent subsystems within the broader public health system. the aspher's european list of core competences, which we used as a main source, acknowledges the challenge to apply their general public health competency profile to such systems [ ] . however, the use of competencies can be pivotal in targeted and effective training for professionals, and the evaluation of their competence, as is proven by many studies [ , , [ ] [ ] [ ] . to support the development of well-functioning infectious disease systems at airports, we made general formulations more specific and added setting-specific knowledge, skills and attitudes to end up with this airport setting-specific competency profile. we, therefore, demonstrate in this study, that it is possible to design a competency profile for airports across countries. presumably, other points of entry, such as ground-crossings or ports, would also benefit from a setting-specific profile. these have a regulated and sustainable role in prevention of cross-border spreading of diseases and face comparable challenges to airports. examples are fisheries [ ] , drilling platforms [ ] , and many other mass gatherings [ ] or other places imaginable where an international transfer of people and goods take place, and where infectious disease diseases might be introduced. during the development of the profile, we learned more about the possibilities and challenges of competencies. both during the extraction of competencies from the literature, as well as during the consensus meeting we experienced that the concise and theoretical formulations of the competencies sometimes thwart their usability. it happened to us, as well as to the participants, that competencies had to be read and reread out loud before the full meaning of a competency was fully understood. the usability of the competency profile can be enhanced in several ways. for example, the use of entrustable professional activities (epa), as used in medical education, may bridge a potential gap between the theory of competencies and practice. an epa tells whether a professional can be entrusted to carry out all critical activities of a major task [ ] . they integrate the demonstration of competence with the respective supervision level and hereby form a usable tool during education or training activities. because our profile covers competencies required by the team of professionals involved in infectious disease management, participants experienced that competencies could only be translated into practice in close collaboration with different disciplines replicating findings of previous studies [ ] . another possibility to increase the usability of this profile is to merge disciplinary competencies into functional roles at an airport. in line with recommendations from • equip relevant airport and airline staff with information regarding the public health event so that they can protect themselves and safeguard healthy travelers as required. • organize the use of public health measures underpinned by scientific evidence and expert public health opinions, so as to avoid any contradictory or unnecessary restrictions of individuals. health expert • clearly define goals and objectives of the evaluation of training, exercises or real response. • develop a formal evaluation of the response, including recommendations for prevention and mitigation for future incidents, and share the evaluation with all stakeholders when the public health event is under control or has concluded. this study's participants, the profile could be minimized to a specific group of people, for example, first responders. a third option, is to use the profile and apply it in practice. discussing the profile enhanced usability according to our participants. in addition, we lowered the barrier of translating the theoretically formulated competencies into practice by inviting our participants to think of a possible event. during the international questionnaire, people noted which event they had used during completion. remarkable is that all the events listed comprised a viral hemorrhagic fever. while the chance for an event or suspicion of a viral hemorrhagic fever is still low, it is an interesting finding that its high impact, possibly due to the evd pandemic of - and the recent endemic state in the democratic republic of the congo, affects the thoughts of preparations in europe. remarkable findings in the profile are the low number of competencies for recovery and evaluation after an event. in the airport guidelines that we used as a source, evaluation and recovery are scarcely named and hardly elaborated on [ , , ] . however, the use of after action reviews are a required action according to the ihr, and major benefits of either training or real response are made here [ , ] . it is therefore worrisome that this phase of the event is hardly elaborated upon in current landmark guidelines and competency profiles, and, consequently, is scored as a rather small topic in this study's competency profile. we cannot determine, however, whether the small number of competencies resembles the real need or resembles a lack of awareness. we suggest to critically review the competencies required for recovery and the after action review after a major event. it may seem remarkable that many competencies in our profile are knowledge or skills in comparison to attitudes. this could be the result of several aspects. first, we build upon former general profiles and focused on competencies specific for the airport setting. attitudes such as leadership, flexibility, team work or reflection are mostly general, i.e. not airport-specific. in addition, these are already widely covered in the team resource management skill set, which is additional to our profile and focusses on attitude [ ] . however, another possibility is that knowledge and skills are more concrete while attitudes remain harder to distinguish by our participants. the use of this profile in practice should indicate whether attitudes are sufficiently covered. we consider it as a unique opportunity to thoroughly and extensively develop a competency profile by performing two consecutive rand modified delphi studies, one at schiphol airport, one of europe's largest airports, and one internationally with experts from ten european countries. as in every study, we faced several challenges that we tried to cope with. first, composing a draft profile demanded a pragmatic step of combining and formulating competencies of different profiles and guidelines. diminishing the large amount of overlapping competencies with slight differences in word choice, specificity level and combinations of activities was done as systematically as possible based on thoroughly produced profiles in the international literature to present an assessable profile to the participants. another challenge was to compose expert panels with optimal representation of all involved disciplines. in the national study, we could not include all professionals involved in infectious disease management at schiphol airport. however, we assume to have caught the major perspectives, since professionals that are involved with most tasks were represented. in addition, all included participants were highly experienced in outbreak management and collaborated with the missing experts in daily practice. during the international study, we had to select participants based on their self-assessed competence regarding the subject and could not prevent a mixed group regarding experience in real practice. we therefore consider it a strength that the international participants all participated in the european training course, leading to an equally educated group in the consensus meeting. a third challenge is to design a profile that is internationally usable while it turned out that designation of tasks between national, regional or airport levels differs among countries. however, we explicitly demanded participants to look further than the specific situation at their airport, leading to a profile that forms a thorough base for training in european countries. future steps would be to test the usability and implementation of this profile in real practice by means of trainings, exercises and evaluations. it is our aim that this profile is applied at airports worldwide to facilitate a competent workforce, by integrating it in training or exercising schedules as training material or background reference for organizers. standardized and extensive use of this profile could help to standardize terminology among professionals, and contribute to better communication and coordination. subsequent development of tools such as an epa profile on a european level, or the implementation of competencies into discipline specific profiles at specific airports are possibilities. finally, we hope that this competency profile can be used as a basis to develop specific competency profiles for points of entry other than airports, or other settings important in cross-border spreading of disease. in this study, we developed an interprofessional competency profile for professionals involved in infectious disease preparedness and response at airports by means of landmark literature and expertise from professionals in eleven european countries. this profile could be considered as promising 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globalization and health the authors are thankful to all participants for sharing their knowledge and practical experience. we thank saskia van egmond for her help in selecting the best representable panel, and for her advice and enthusiasm during the project. we thank eline westland-hogenbirk for the configuration of fig ; jeannette de boer for her reflections, including on the future applications and usability of our profile; and corien swaan for her contributions before and during the international consensus meeting; and our colleagues from the eu joint action healthy gateways for the opportunity to perform our study during the training-of-trainers in belgrade. conceptualization: doret de rooij, evelien belfroid, aura timen. key: cord- -jj fqcen authors: freudenberg, nicholas title: health research behind bars: a brief guide to research in jails and prisons date: journal: public health behind bars doi: . / - - - - _ sha: doc_id: cord_uid: jj fqcen while most people make staying out of jail and prison a priority, a growing number of researchers are eager to get into correctional facilities in order to study the criminal justice system, the causes and consequences of incarceration, and the role of corrections in our society. for health researchers and their collaborators, the audience for this chapter, correctional facilities offer several unique advantages: a population at high risk of many health problems including infectious and chronic diseases, substance abuse, and mental health problems; social and physical environments that can enhance or impede well-being; a setting that is a focal point for the class, racial/ethnic, and gender differences that divide the united states; a site where health and mental health services and prevention programs are offered and can be evaluated; a controlled environment for administration of treatments such as directly observed therapy for tuberculosis; and a stopping point in the cycle of incarceration and reentry that so profoundly affects community well-being. while most people make staying out of jail and prison a priority, a growing number of researchers are eager to get into correctional facilities in order to study the criminal justice system, the causes and consequences of incarceration, and the role of corrections in our society. for health researchers and their collaborators, the audience for this chapter, correctional facilities offer several unique advantages: a population at high risk of many health problems including infectious and chronic diseases, substance abuse, and mental health problems; social and physical environments that can enhance or impede well-being; a setting that is a focal point for the class, racial/ethnic, and gender differences that divide the united states; a site where health and mental health services and prevention programs are offered and can be evaluated; a controlled environment for administration of treatments such as directly observed therapy for tuberculosis; and a stopping point in the cycle of incarceration and reentry that so profoundly affects community well-being. in this chapter, i consider the benefits and perils of doing health research in jails and prisons. the chapter begins with a brief overview of the different types of health research conducted within correctional facilities and among those leaving jail or prison. i then describe some of the unique obstacles that correctional health researchers encounter and assess some of the methods they have used to overcome these obstacles. since researchers in correctional settings face significant ethical dilemmas, i next consider recent frameworks for making ethical decisions about this research. finally, i suggest an agenda for future health research in correctional settings. health research behind bars: a brief guide to research in jails and prisons in recent decades, researchers from a variety of disciplines including health services research, public health, medicine, criminal justice studies, sociology, psychology, anthropology, organizational studies, and others have initiated studies on health in the correctional system. a brief typology of the different categories of questions these investigators have asked will help to set the stage for our consideration of approaches to correctional research. . what are the health and social characteristics of people in jail and prison? numerous studies have examined the health and demographic profile of incarcerated populations. these vary from large studies based on national samples and using multiple health outcomes such as the reports of the national correctional health care commission on the health status of soonto-released inmates ( a, b) or of the health status of inmates in texas prisons (baillargeon, black, pulvino, & dunn, ) to studies of a single outcome such as hepatitis c among california inmates (fox et al., ) . the various reports of the bureau of justice statistics on mental health, substance use, and other health conditions (e.g., james & glaze, , karberg & james, summarize data across u.s. jurisdictions, providing an opportunity for correctional and health officials to identify incarcerated populations in higher need. other studies describe patterns of health care utilization among inmate populations (leukefeld et al., ) . investigators often compare the health status of different subpopulations, e.g., men to women (peters, strozier, murrin, & kearns, ) , or african-americans and latinos to whites (rounds-bryant, motivaus, & pelissier, ) . these descriptive studies are used to identify the needs of various segments of the incarcerated populations, to compare changing incidence or prevalence of conditions over time, or to serve as a baseline for the subsequent evaluation of interventions. research imperatives in these studies are consistent definitions of dependent and independent variables, uniformity in data collection methods in multisystem studies, and sampling strategies that enable generalizations to other settings. . how does the health of inmates differ from that of nonincarcerated populations? a second group of studies compare the health of incarcerated populations with the health of the general population or with samples of nonincarcerated people. for example, teplin and colleagues' studies of the prevalence of mental health conditions among women and juveniles in chicago jails found higher rates of some psychiatric conditions in incarcerated populations than in similar populations living in the same catchment area from which inmates had been arrested (teplin, ; teplin et al., ) . these studies set the stage for the next group of studies. methodological issues in this type of study include selecting an appropriate comparison group. . how does incarceration itself affect the health of incarcerated populastions? both correctional and public health authorities want to know whether observed differences between incarcerated and nonincarcerated populations are due to differences in the composition of the populations or to the experience of incarceration, a variant of the classic epidemiological task of distinguishing between compositional (i.e., characteristics of the population) and contextual effects (i.e., characteristics of an environment). for example, numerous investigators have sought to determine whether the higher prevalence of hiv infection among u.s. prison populations was due to intraprison transmission or to criminal justice policies that led to incarceration for people already hiv infected (hammett, ; krebs & simmons, ) . most studies suggest the latter route is more important, reassuring correctional authorities that within-prison transmission, while it does occur, is not a major factor in higher rates. on the other hand, studies in the early s established that tb transmission did occur within the facility, leading to substantial efforts to prevent such transmission (bellin fletcher, & safyer, ) . others have investigated whether incarceration is associated with homelessness and mental illness (mcneil, binder, & robinson, ) . the main analytic task in these studies is to distinguish between causal and noncausal associations between incarceration and selected health outcomes. . what are the health effects of criminal justice policies and practices on the health of inmates? criminal justice policies often have unintended effects on incarcerated populations. documenting the positive and negative impact of these policies can serve as a starting point for policy change. for example, a study in a large public hospital in new york city found that many admissions for diabetic ketoacidosis were related to the court practice of denying inmates access to insulin medications in court pens (keller et al., ) . health impact assessment, an analytic method developed to assess the health effects of both health and non-health-related policies, offers a promising approach to consider the health consequences of various prison and criminal justice policies (davenport, mathers, & parry, ; kemm, , veerman, barendregt, & mackenbach, . to date, however, this approach does not seem to have been used to assess the impact of u.s. correctional policies on inmate or community health. . what is the impact of interventions designed to care for or improve the health of incarcerated populations? a key practical question for correctional, public health, and correctional health officials is the effect of the programs they run on the well-being of the populations in custody. evaluation studies seek to document the utilization of health services (lindquist & lindquist, ) ; assess their impact on health or health care utilization (e.g., chan, vilke, smith, sparrow, & dunford, ; edens, peters, & hills, ) ; analyze the cost-benefits of an intervention (ncchc, a) ; or compare the cost-effectiveness of various approaches to a specified health problem, e.g., screening for hiv or other infectious diseases within correctional settings (resch, altice, & paltiel, ; kraut-becher, gift, haddix, irwin, & greifinger, ) . in these studies, methodological issues include the specification of clearly defined outcomes, the use of standard accepted measures for assessing costs and benefits of various interventions, and the design of evaluation studies that are both methodologically sound and operationally feasible. . how does reentry affect the health of incarcerated populations? in the last decade, correctional health researchers have begun to follow their research participants back into the community, examining their success in finding health services or drug treatment (jarrett, adeyemi, & huggins, ; lincoln et al., ) , maintaining control of a mental health condition (wilson & draine ) , or in improving hiv care or reducing hiv risk behavior (bauserman et al., ; rich et al., ; myers et al., ) . these studies can be part of an evaluation of a reentry program (e.g., needels, james-burdumy, & burghardt, ) or a descriptive study of the outcomes of the reentry process (e.g., freudenberg et al., ) . . what is the impact of incarceration rates on the well-being of communities and populations? finally, a growing number of researchers are studying the impact of incarceration and correctional policies on the health of families, communities, and populations. for example, some research looks at the impact of incarceration on children and other family members (murray & farrington, ; barreras, drucker, & rosenthal, ) . researchers have asked whether incarceration policies have contributed to the community transmission of hiv infection (leh, ; johnson & raphael, ) or other sexually transmitted infections (thomas & sampson, ) , community rates of violence (rose & clear, ) , or disparities in health between black and white u.s. populations (taxman, byrne, & pattav, ; johnson & raphael, ; iguchi, bell, ramchand, & fain, ) . these studies can help policy makers consider the impact of various incarceration policy choices. this brief summary of the types of questions that correctional health researchers have sought to answer illustrates the scope of the field. for neophyte investigators, becoming familiar with the findings and methodological challenges in the extant literature relevant to their question of interest can save years of trial and error in this difficult setting and avoid duplication of effort. for more experienced researchers, a familiarity with the scope of prior research can help them move from descriptive to analytic and intervention studies. several recent reviews provide a good starting place for becoming familiar with recent correctional health research (edens et al., ; freudenberg, ; magaletta, diamond, dietz, & jahnke, , morris, pollack, khoshnood, & altice, ) . successful health research in correctional settings requires familiarity with the existing literature described in the previous section, a knowledge of the research methods applicable to the correctional setting, discussed in the next section, and an understanding of the various stakeholders in correctional health, discussed here. without a map of this organizational landscape, even skilled researchers can lose their way. key participants in developing and implementing research studies in correctional settings include correctional officials, correctional health providers, public health authorities, other researchers and research institutions, elected officials, funders, prison and reentry advocacy groups and inmates and their families. each of these constituencies has the potential both to improve research and to stop studies before they get off the ground. thus, the practical researcher will want to understand how to enlist each of these groups in supporting the research process. correctional officials need to approve and at least not oppose any research study conducted in their facility. their main concerns are the extent to which research may pose a threat to safety and regular prison routines, fear of bad publicity, cost and liability concerns, or additional demands on their staff. researchers who can reassure correctional officials on these matters will have an easier time pursuing their studies. investigators who are unable (or un willing) to provide these assurances may need to consider other approaches to their research, such as interviewing participants after their release from jail or prison. in most situations, research studies will need the tacit support of at least three levels of correctional authorities: senior departmental managers (e.g., commissioners/directors or sheriffs); wardens of the facility(ies) where the study takes place; and frontline correctional staff. each level brings different concerns and requires different assurances in order to allow the research to proceed. for example, frontline correctional officers who may be required to bring participants to the researcher for interviews or medical examinations want to make sure these procedures do not interfere with their routines or increase staff workloads. wardens often need to be assured that no research procedure will jeopardize security. in another example, a jail security warden was concerned that a stylus for a handheld computer device used for interviews with inmates could be used as a weapon. it took several meetings between a warden and a research team to agree on a type of stylus and interview procedures. senior officials of corrections departments are sometimes ambivalent about studying illegal behavior such as drug use or voluntary or coercive sexual behavior. if they know that a problem exists, they may have an obligation to address it so that agreeing to research on these topics can have significant administrative, legal, and cost implications. researchers will need to be prepared to address these concerns. correctional health providers have a constitutional mandate to provide health care to people in custody, offering a theoretical rationale for research that helps to improve care or make it more efficient or economical. in practice, however, since the types and quality of these services are often the subject of litigation (nathan, ) , health providers often filter requests for participation in research projects through their potential impact on current or future litigation. in addition, similarly to corrections officials, correctional health authorities often believe that if they know about a problem they will be required to take action to address it. this has made some officials reluctant to support research on difficult-and expensive-conditions such as hepatitis c (spaulding et al., ) . researchers who want to study such topics will need to be able to address these concerns. correctional health providers operate under a variety of auspices, including public departments of corrections or health, universities, voluntary hospitals, or for-profit companies (mellow & greifinger, ) . these differing organizational sponsorships influence a unit's openness to research and their motivation to participate in research studies. as with other potential stakehold-ers, researchers need to initiate a straightforward discussion to identify areas of common interest and potential conflict before beginning a study. in some cases, correctional health providers have themselves initiated evaluation studies to guide practice. for example, the university of texas, which has a contract to provide health services for inmates in texas prisons, commissioned an independent evaluation of its services. the report generally lauded the texas program and made several suggestions for more systematic quality assessment (texas medical foundation, ) . public health authorities often have a legal mandate to provide oversight of correctional health services and always have responsibility for providing core public health services to people returning to their communities. these obligations provide an incentive for research that can identify unmet needs, improve the effectiveness or quality of care or reduce its costs, or demonstrate the impact of interventions. in practice, some state and municipal health departments have close and positive relationships with correctional health researchers and enlist their help in identifying and solving problems. others, either as a result of fears of litigation, new mandates for service, or unfavorable media attention, may be reluctant to establish partnerships with researchers. other researchers and research institutions can provide an important resource for both experienced and neophyte correctional health investigators. they can share their frontline experiences doing research in specific correctional systems or facilities, the study designs and instruments they have used, their solutions to issues of confidentiality and informed consent, or their findings from their previous research. in the last decade or so, a number of research centers focused on correctional health or reentry have been established, gaining valuable experience and producing a body of work that can inform future studies. some of these are listed in table . . since some federal funding agencies prefer multijurisdiction research projects in order to increase generalizability, establishing partnerships with experienced centers can help to design such studies and win funding for them. elected officials in both the executive and legislative branches are sometimes needed to approve funding for research studies (e.g., evaluation of publicly funded health or reentry interventions) or to pose questions that need study to correctional or health officials (e.g., how best to provide substance abuse treatment services to people in and returning from correctional facilities). in order to help these officials take on these roles, researchers can provide them with information documenting the problem, cost arguments on the potential savings from new approaches, and the public health benefits of correctional health services. many elected officials worry that supporting health services or even research on the health needs of people in jail or prison might lead to charges that they are "soft on crime" or coddling criminals. research evidence that can reframe the issues as public health, public safety, or economic concerns may help to provide a rationale for interest. funders provide the financial support for correctional and reentry health research and thus for this research to develop they must be willing to provide the level and continuity of funding needed to develop the field. given that both private and public funders always have more requests for support than resources, that prison health is always a less popular choice than, say, children's health or education, and that many funders change their priorities ( ) http://cira.med.yale.edu/ regularly, researchers face an uphill battle in winning the resources they need to pursue a comprehensive research agenda on correctional health. funders who have provided significant support to correctional health research include public agencies such as the national institutes of drug abuse, alcohol abuse and alcoholism, mental health, and allergy and infectious diseases, the centers for disease control and prevention, the national institute of justice, and some state and local governments. private funders include the robert wood johnson foundation, the kellogg foundation, the open society institute, and the jeht foundation, among others. to ensure long-term support, correctional health researchers will need to educate public and private funders about the connections between correctional health and public safety, public health, and social justice as well as to find ways to integrate correctional health issues into research on a variety of health and social problems. prison and reentry advocacy groups serve as important bridge between inmates and their families and the wider community. they also have the potential to influence policy makers, elected officials, and the media. their opposition to unsafe or unhealthy prison conditions, inadequate medical care, or violations of civil liberties have contributed to the development of standards for correctional health care and greater public attention to these issues (nathan, ) . the mission, scope, and activities of these groups vary widely, from national organizations such as the national prison project of the american civil liberties union, which brings legal action against correctional systems alleged to violate inmate rights, and critical resistance, an alliance of regional groups dedicated to radical reform of the criminal justice system, to local groups that seek to coordinate reentry programs or organize prison visiting programs. for researchers, these groups can provide detailed knowledge about prison conditions, inmate perceptions of problems, and the local political climate on correctional issues including health. establishing relationships of mutual trust and respect, even when the two parties may disagree on the causes or solution to a problem of interest, can deepen investigators' understanding of the context in which their research is carried out. finally, inmates and their families can provide the insider knowledge that can determine the success or failure of a research project. their understanding of the real-world intersection of policy and practice, the actual living conditions of inmates, and the problems that people leaving jail and prison face when they return home can help researchers to design their studies, develop their research instruments, and interpret their findings. many researchers have noted the benefits of participatory research-deeper knowledge of the problem under study, greater engagement of research participants in the process, and more meaningful interpretation of results (israel, schulz, parker, & becker, ; metzler et al., ) . in summary, correctional health researchers interact with a variety of stakeholders. at worst, these interactions can appear as a gauntlet of opponents, each with contradictory perceptions and demands that threaten the integrity of the research process and have the potential to disrupt or even halt any study. at best, however, each stakeholder can offer unique insights into the research problem, contribute distinct resources to the research process, and assist in making findings lead to improvements in practice, policy, and health. thus, developing skills in successfully negotiating these interactions is an essential prerequisite for the correctional health researcher. researchers in correctional facilities have used a wide variety of data sources to study inmate health. these include surveys of inmates or correctional authorities, clinical studies of inmate health, secondary analyses of national datasets, ethnographies, and reviews of existing prison health or criminal justice records. each of these sources of data has unique advantages and disadvantages. increasingly, researchers combine different types of data in order to gain deeper insights into the question of interest. for example, many correctional health studies will integrate survey data from participants, medical records from a correctional health service, and official criminal justice records in order to assess the impact of intervention programs. in general, the methodological questions in correctional health are similar to those in other settings: e.g., how to define variables of interest consistently, how to ensure that the data collected are reliable and valid, and how to select appropriate samples and comparison groups. a variety of standard research texts can help investigators to become familiar with these issues (e.g., boruch, ; datzker, ; noaks & wincup, ; patton, ) . research in correctional settings does pose some particular methodological challenges. for example, longitudinal studies that follow inmates into the postrelease period face the problem of locating participants after release. since people leaving jail or prison often lack residential stability and may not want further contact with those associated with the incarceration experience, achieving acceptable follow-up rates can be difficult. strategies that have been used to increase follow-up rates include collection of multiple contact names at study entry; frequent interim contacts in order to maintain updated locators, use of both service and financial incentives, and use of public records (e.g., "rap sheets" and criminal records) in lieu of face-to-face contacts. correctional health researchers, like other investigators, often struggle to design and implement multilevel studies that seek to understand the cumulative impact of more than one level of organization on inmate or community health. they may collect data on individuals, social networks such as family and peers, communities, correctional facilities, and jurisdictions, then seek to analyze the contribution each level makes to a specified outcome. for example, a study of women and male adolescents leaving new york city jails examined the impact of individual characteristics, the jail and reentry experience, conditions in the returning community, and changing municipal policies on crime, welfare, and housing on returning inmates' drug use, hiv risk behavior, and reincarceration (freudenberg et al., ) . multilevel analyses consider the contributions of variables at multiple levels to the variability in a particular individual-level dependent variable, e.g., drug use. in public health, multilevel research is increasingly used to assess the relative influence of neighborhood and individual-level variables on health (diez-roux, ) . by comparing these two influences within different jurisdictions, a third level of organization (i.e., city or state policies or services) can be studied. health research in correctional settings also faces organizational and logistical issues. these include finding space for confidential interviews (an extremely challenging task in overcrowded jails and prisons), negotiating use of technology such as computer-assisted interviewing devices with prison security officials, providing clearance and escorts for researchers, and gaining consistent and reliable access to research participants within the security confines of the facility. solving these logistical problems requires a close and collaborative relationship between researchers and correctional officials. defining common objectives at the inception of research, developing procedures for resolving conflicts before they emerge, and maintaining open communications with all levels of correctional authorities-from frontline correctional officers to wardens and commissioners-can help to reduce logistical problems. most importantly, researchers who choose to work in correctional settings must be willing to act as guests in someone else's house, rather than expect to develop their own rules of conduct. researchers who are unable or unwilling to accept this reality will face difficulty in working in prisons or jails. perhaps the most challenging aspect of health research in correctional settings is meeting the competing demands for ethical research practice as mandated by various bodies as well as the researcher's own ethical standards. prisoners pose ethical dilemmas for researchers not only because they lack the freedom to make the choices that most individuals in the free world take for granted, but also because so many prisoners experience other problems that make them vulnerable as research subjects: low levels of literacy, hiv infection, mental illness, victims or perpetrators of violence, as well as being adolescents. ethical questions correctional health researchers must address include: • what procedures ensure that all incarcerated people involved in studies have been given the opportunity to give informed and voluntary consent to participate in the research? • what research practices can guarantee that inmates have as much right to choose to participate in research as any other population? • how do correctional health researchers balance their ethical responsibilities to the correctional officials who commission their work or provide access to inmates with their responsibility to inmates? • what level of individual or population benefits in correctional health research balances potential risks? • how can researchers ensure that participation in correctional health research studies will not lead to harm through disclosure of confidential medical or criminal justice information to third parties? • what ethical responsibility do researchers have to bring the findings of their research in correctional settings to policy makers or others who can act on these finding? a brief review of the recent history of ethical issues in prison research helps to illustrate the competing forces and changing policy priorities. more in-depth discussion of this history can be found elsewhere (gostin, vanchieri, & pope, ; kalmbach & lyons, ; degroot, bick, thomas, & stubblefield, ; haney & zimbardo, ; hornblum, ) . in , hornblum observed that "from the early years of this century, the use of prison inmates as raw materials became an increasingly valuable component of american scientific research" (hornblum, ) . for example, in the s, major pharmaceutical companies, dow chemical, and the u.s. army tested experimental drugs at the holmesburg prison in pennsylvania (hornblum, ) . in , based in part on disclosures of research abuses in prisons, the national commission for the protection of human subjects of biomedical and behavioral research ( ) issued a report that set the framework for subsequent federal involvement in setting ethical standards for human experimentation. their report called for additional protection for certain "vulnerable" populations, including children, neonates, pregnant women, and prisoners. in , the commission issued a report titled "additional protections pertaining to biomedical and behavioral research involving prisoners as subjects" (u.s. dhhs, ) . the main goal of these early guidelines was to protect incarcerated individuals from serving as involuntary or coerced "guinea pigs" in research that offered no direct benefits and had the potential for harm. in the s and early s, the aids epidemic raised new ethical concerns for correctional health researchers. in some cases, prisoners with hiv infection or aids were not permitted to join clinical trials for new aids medications, based on various beliefs including their inability to give truly voluntary consent and their perceived unwillingness to comply with prescribed regimens. some health researchers and prisoners rights advocates argued that such a ban violated ethical principles and that prisoners should have the same access to experimental treatments and clinical trials as other sectors of the population. from this perspective, ethical guidelines should place a priority on ensuring access to potential beneficial treatments (dubler and sidel, ) -a priority that may conflict with the previous emphasis on protecting inmates from researchers. in , the institute of medicine commissioned another review of ethical issues involved in prisoner research (gostin, vanchieri, & pope, ) . based on several reviews of the more recent literature and testimony from dozens of witnesses including researchers, inmates, and correctional officials, the committee on ethical considerations for protection of prisoners involved in research made fourteen recommendations in five broad categories (table . ). these recommendations strive to find an appropriate and updated balance between the protection and access imperatives embodied in previous ethical standards. whether these institute of medicine recommendations lead to changes in federal guidelines for prison research or in practice remains to be seen. in practice, among the vexing problems correctional health researchers face are obtaining voluntary consent in jails or prisons, informing research participants about the benefits and risks of research, getting consent for randomized trials in which some participants receive no potential benefit, protecting the privacy of research participants, and negotiating with irbs that may lack expertise in the realities of prison research. defining "voluntary" consent in the coerced environment of a correctional facility is sometimes difficult. among the practices that can compromise free choice are promises of services not ordinarily available to inmates (e.g., certain types of health services), the presence of correctional officers in the area where consent is being solicited, the unavailability of the independent advice on participation that is normally available to research participants in the free world, or the implied offer to use participation in research in exchange for a shorter sentence or favorable consideration by a judge or parole board. since no set of rules can govern all the situations that can jeopardize voluntary consent, for any particular study the ethical researcher ought to consult experienced correctional researchers, correctional officials at the study site, prisoners rights advocates, and current and former inmates in order to obtain a variety of perspectives on the best procedures to insure voluntary consent. similarly, the process of informing research participants in correctional settings of the risks and benefits of a study can be challenging. many inmates have low levels of literacy; many distrust correctional and health authorities, sometimes based on their own past experiences; and, unlike most research in medical settings, an added risk is disclosure of information that can cause harm to participants from other inmates, correctional staff, legal authorities, or the wider public. research on stigmatized conditions such as hiv infection, mental illness, and substance use almost always poses such risks. methods that researchers have used to overcome these obstacles are to engage current and former inmates in the design of informed consent materials and as members of source: gostin et al. ( ) . irbs, to hire independent advisors who are not part of the research team to help inmates make decisions about participation, and to obtain federal certificates of confidentiality to minimize risk of disclosure of confidential information. while some inmates and ethicists express concerns about the coercion implicit in any research in the correctional setting, the recent iom report (gostin et al., ) also noted that other inmates strongly oppose restrictions on inmate participation in research. some are concerned about lack of access to cuttingedge treatments for hiv or cancer; others object to the loss of opportunities for compensation or enhanced living situations. a specific problem facing researchers involved in clinical trails in which some forms of treatment are withheld from some participants is convincing both staff and participants of the rationale for a randomized trial. from a researcher's point of view, the lack of definitive evidence of the benefits of an intervention is sufficient rationale for such a trial but for staff and participants, withholding services perceived to be beneficial may seem unethical. when staff are not convinced of the morality of a research study, they may intentionally or unintentionally undermine the study, either by providing services to the "control" group or by communicating their discomfort to research participants, thus discouraging enrollment in a study. for this reason, it is important for researchers to address this issue forthrightly. strategies to minimize this problem include offering all research participants some level of services above the standard care in the correctional facility, comparing different interventions to each other rather than to no special services, educating research staff about the ethics of offering unevaluated services to all participants, and, as the institute of medicine report on correctional research suggests (gostin et al., ) , joining advocacy efforts to improve the basic standard of care in all correctional facilities. in my experience, many correctional health researchers complain about the extensive and lengthy process required to get irb approval for their research study and suggest that it can discourage them from pursuing worthy projects. in some cases, several different irbs need to approve a single study and occasionally offer conflicting guidance on how to proceed. these complaints have a variety of sources: some investigators prefer the old way of business where researchers alone decided on the conduct of their studies. but even researchers who support the importance of protecting prisoners note that irb members often lack expertise in the day-to-day realities of correctional institutions and the nonresearch risks inmates encounter daily. they also report that irb committees often reflect the wider tension between protecting participants from research harm and ensuring access to beneficial services and in their effort to maximize both of these aims impose unreasonable demands on researchers. a possible solution is to assist irbs to find a member who is experienced in correctional settings and correctional research-not only to meet the dhhs regulatory requirement to include such a person but also to obtain practical advice on devising realistic and ethical resolution of problems. for example, one state prison system irb included an attorney who specialized in inmate litigation. another solution, as recommended by the iom report (gostin et al., ) , is to develop universal national standards for review of prison research so that all research is reviewed using uniform criteria. at present, correctional health researchers respond to a variety of heterogeneous influences -other criminal justice, medical, public health, and public policy researchers; local, state, and federal correctional and health officials; correctional health providers; a variety of professional organizations; elected policy makers; and various criminal justice and health advocacy organizations, among others. it is therefore not surprising that in this anarchic and complex environment correctional health researchers have yet to develop a coherent and comprehensive research agenda driven by existing scientific knowledge and public policy imperatives. however, the fact that it may be difficult to envision and articulate such an agenda should not stop the effort. in fact, as health and correctional officials and researchers request additional support for correctional health research, it is inevitable that they will be asked to set priorities. and if researchers themselves fail to take the lead in this process, others will impose an agenda on them. while the development of a comprehensive research agenda for correctional health is beyond the scope of this chapter, i conclude by suggesting some steps that might move the field in this direction. first, we need to begin a national dialogue on research needs that include researchers, correctional and health officials, policy makers, and advocates. questions to discuss include: what are the most promising avenues of research to lead to short-and middle-term improvements in the health of incarcerated populations? what are potential stable funding streams for this research? how best can we develop consistent frameworks for research so that clinical, practice, and policy decisions can be more evidence-based? who are the constituencies that will support a national research agenda on correctional health and how can these constituencies be organized into a coherent force? what correctional research might be particularly beneficial both to the health of the incarcerated and to the larger health of the public? organizations that can play a role in this national discussion include the national institute of justice, nih institutes and the centers for disease control and prevention, the national commission on correctional health care, various health professional organizations, and the reentry policy council. second, researchers need to synthesize the existing and disparate literature on correctional health to identify common findings, gaps in the literature, and future priorities. this literature is dispersed in several different disciplines and among the peer-reviewed and "gray" literatures, i.e., public and voluntary organization reports and studies. one possible sponsor for such a critical review would be the institute of medicine. third, as recommended by the recent iom report on correctional health research (gostin et al., ) , the united states should establish more consistent and uniform guidelines for ethical health research among incarcerated populations. such guidelines will protect researchers and inmates and help to resolve the continuing debate between protection from researchers and full access to the benefits of research. fourth, any agenda should consider the range of settings in which correctional health plays out, including courts, jails, prisons, parole and probation services, alternatives to incarceration, and reentry programs. too often, each setting has been its own silo with a cadre of researchers and officials. the evidence of the past decades suggests that in fact these settings constitute a single if sometimes disorganized system in which changes in one component affect all others. thus, health research needs to examine these systemic interactions in order to avoid shifting problems for one sector to another. finally, correctional health research has to be considered a branch of population health research and therefore address the broadest questions that affect the health of the public. in the past, some correctional health researchers have limited their attention to those individuals served in correctional health settings-the patients who walked through their clinic doors. while these concerns will continue to be important and warrant focused investigation, they are not sufficient to realize the full opportunity for correctional health researchers to improve health. research questions that need to be addressed in the coming decade include: how does incarceration influence socioeconomic, racial, and gender disparities in health in the united states? how does incarceration affect the health of the families and communities of incarcerated individuals? what role can correctional health services play in reducing community incidence, prevalence, severity, or costs of conditions such as hiv infection, hepatitis c, diabetes, asthma, addiction, violence, depression, or lack of health insurance? by expanding their focus to these questions, correctional health researchers have the potential to contribute to solving our nation's most pressing health problems. correlates of hiv infection among incarcerated women: implications for improving detection of hiv infection at the intersection between poverty, race, and hiv infection: hiv-related services for incarcerated women the disease profile of texas prison inmates the concentration of substance use, criminal justice involvement, and hiv/aids in the families of drug offenders hiv prevention with jail and prison inmates: maryland's prevention case management program association of tuberculosis infection with increased time in or admission to the new york city jail system randomized experiments for planning and evaluation: a practical guide (applied social research methods) impact of an after-hours on-call emergency physician on ambulance transports from a county jail reducing hiv risk among women visiting their incarcerated male partners readings for research methods in criminology and criminal justice use of health impact assessment in incorporating health considerations in decision making clinical trials in correctional settings: right or regression? investigating neighborhood and area effects on health understanding community re-entry among former prisoners with mental illness: a conceptual model to move new research on research on hiv infection 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past and future of u.s. prison policy: twentyfive years after the stanford prison experiment a framework for management of hepatitis c in prisons they were cheap and available: prisoners as research subjects in twentieth century america acres of skin: human experiments in holmesberg prison how criminal system racial disparities may translate into health disparities review of communitybased research: assessing partnership approaches to improve public health mental health problems of prison and jail inmates bridging the gap: providing health care to newly released men the effects of male incarceration dynamics on aids infection rates among african-american women and men from evidence to action on hiv/aids in prisons: a report from the xvi international aids conference ethical and legal standards for research in prison substance dependence, abuse and treatment of jail inmates diabetic ketoacidosis in prisoners without access to insulin health impact assessment: a tool for healthy public policy cost-effectiveness of universal screening for chlamydia and gonorrhea in us jails intraprison hiv transmission: an assessment of whether it occurs, how it occurs, and who is at risk a review of the legal and ethical issues for the conduct of hiv-related research in prisons hiv infection in u.s. correctional systems: its effect on the community a prospective examination of high-cost health services utilization among drug using prisoners reentering the community treating incarcerated women: gender matters facilitators and barriers to continuing healthcare after jail: a communityintegrated program health behind bars: utilization and evaluation of medical care among jail inmates the mental health of federal offenders: a summative review of the prevalence literature incarceration associated with homelessness, mental disorder, and co-occurring substance abuse successful reentry: the perspective of private correctional health care providers through community-based participatory research partnerships the health of youth in the juvenile justice systems parental imprisonment: effects on boys' antisocial behaviour and delinquency through the life-course get connected: an hiv prevention case management program for men and women leaving california prisons taking stock of the accomplishments and failures of prison reform litigation: have the courts made a difference in the quality of prison conditions? what have we accomplished to date? community case management for former jail inmates: its impacts on rearrest, drug use, and hiv risk criminological research: understanding qualitative methods qualitative research and evaluation methods treatment of substance-abusing jail inmates examination of gender differences health care delivery strategies for criminal offenders cost-effectiveness of hiv screening for incarcerated pregnant women successful linkage of medical care and community services for hiv-positive offenders being released from prison linkages between in-prison and community-based health services incarceration, reentry, and social capital: social networks in the balance comparison of background characteristics and behaviors of african-american, hispanic, and white substance abusers treated in federal prison: results from the triad study effectiveness of antiretroviral therapy among hiv-infected prisoners: reincarceration and the lack of sustained benefit after release to the community effectiveness of antiretroviral therapy among hiv-infected prisoners: reincarceration and the lack of sustained benefit after release to the community report on a national survey of correctional health facilities: a needs assessment of health issues sex offenders, sentencing laws and pharmaceutical treatment: a prescription for failure racial disparity and the legitimacy of the criminal justice system: exploring consequences for deterrence the prevalence of severe mental disorder among male urban jail detainees: comparison with the epidemiologic catchment area program prevalence of psychiatric disorders among incarcerated women. i. pretrial jail detainees an evaluation of correctional health care services provided by university of texas medical branch correctional managed care to the texas department of criminal justice: an assessment of managed care service delivery systems, adherence to correctional health care standards and clinical outcomes high rates of incarceration as a social force associated with community rates of sexually transmitted infection code of federal regulations: title quantitative health impact assessment: current practice and future directions collaborations between criminal justice and mental health systems for prisoner reentry reentry planning for mentally disordered inmates: a social investment approach key: cord- -vk gm j authors: selgelid, michael j.; kelly, paul m.; sleigh, adrian title: tb matters more date: journal: international public health policy and ethics doi: . / - - - - _ sha: doc_id: cord_uid: vk gm j tuberculosis (tb) is the second leading infectious cause of mortality worldwide and arguably the most important neglected topic in bioethics. this chapter: ( ) explains the ethical importance of tb, ( ) documents its neglect in bioethics discourse, ( ) maps the terrain of ethical issues associated with tb, and ( ) advocates a moderate pluralistic approach to ethical issues associated with tb. resistance (which may imply return to a situation analogous to the pre-antibiotic era); and the specter of bioterrorism. second, because they can be contagious and cause acute illness and death, infectious diseases raise difficult ethical questions of their own (smith et al. ; selgelid ) . public health measures for controlling epidemics may include surveillance, mandatory treatment or vaccination, and coercive social distancing measures such as isolation and quarantine. because measures such as these may conflict with human rights to privacy, consent to medical treatment, and freedom of movement, an ethical dilemma arises. how should the social aim to promote public health be balanced against the aim to protect human rights and liberties in the context of diseases that are to varying degrees contagious, dangerous or deadly? third, because infectious diseases primarily affect the poor and disempowered, the topic of infectious disease is closely connected to the topic of justice, a central concern of ethics. bioethics has not entirely ignored the topic of infectious disease. aids, in particular, has received a great deal of discussion in the bioethics literature. in a related development, public health ethics has become a rapidly growing subdiscipline of bioethics as is evidenced by a number of recent books (coughlin et al. ; beauchamp and steinbock ; gostin ; boylan ; anand et al. ; selgelid et al. ; balint et al. ; dawson and verweij ) and (as of ) a new journal-public health ethics (oxford university press). at least some of this literature has emphasized infectious disease in particular. with the exception of aids, however, bioethics discussion of infectious disease remains in its infancy, and coverage of topics has been patchy at best (tausig et al. ) . much of the emerging literature has focused on sars, pandemic influenza, and bioterrorism in particular. there has also been an increase in relevant debate about intellectual property rights in pharmaceuticals-and the barriers patents pose to medication access in poor countries (schüklenk and ashcroft ; cohen and illingworth ; sterckx ; pogge ; cohen et al. ). tuberculosis (tb) is a bacterial infectious disease that is usually spread by coughing. tb illness is debilitating in the short term; and it is associated with high mortality if untreated, and with significant disability even if successfully cured. whilst pulmonary tb (disease affecting the lungs) is the most common and most infectious form of the disease, tb can affect any part of the body. tb is strongly associated with poverty and is common in less-developed countries, particularly in asia, africa, and south america. there has been a resurgence of tb in relation to the hiv/aids pandemic, particularly in sub-saharan africa (dye et al. ). the public health implications of tb are enormous. until recently tb was the world's leading infectious cause of mortality, and it is now second only to aids. it is surprising and unfortunate that there has not been much focused discussion of ethical issues associated with tb, which is arguably the most important neglected topic in bioethics. because tb kills nearly as many people as aids each year, one would expect tb to receive a proportionate amount of discussion in health ethics literature. there are, furthermore, good reasons for thinking that the problem of tb is even more ethically important than aids. in the vast majority of cases tb drugs can provide cure, and they are much less expensive than aids medications. while . million people die from tb each year (who a) and . million die from aids (unaids ) , the former deaths are, economically speaking, much easier to prevent. a standard course of tb medication can cost as little as us$ or us$ , and tb therapy is considered to be one of the most costeffective health care interventions. in best case scenarios, aids medication costs as little as $ for a year of treatment in developing countries, but it often costs much more. in the case of aids, furthermore, lifelong treatment is required because no cure exists. given cost considerations, the case for increasing access to tb medication appears stronger than the case for increasing access to aids medication (which is not to say that the case for increasing access to aids medication is not itself enormously powerful). in , only % of those in need had access to tb therapy recommended by world health organization (who), and the rate was only % just a few years earlier in (lienhardt et al. ) . there have been impressive gains in access to tb services in many countries in recent years, and approximately % of those in need were receiving treatment in (floyd ). significant gaps remain, however, in many of the countries where tb is most prevalent (dye et al. ) . a final reason for thinking that tb is ethically more important than aids is that the former, being airborne, is both contractible via casual contact and much more contagious. while behavior modification (with respect to iv drug use and sexual practice) can essentially eliminate the risk of infection with aids, tb can be passed from one individual to another via coughing, sneezing, and even talking. in many ways, then, the threat to "innocent individuals"-and public health in general-is greater in the case of tb. though the ethical importance of tb at least rivals, if it does not surpass, the ethical importance of aids; the former has received comparatively little attention from bioethicists. the lack of attention to ethical issues associated with tb is revealed via searches on the internet. a pubmed search of titles and abstracts (conducted in october ) for the terms "ethics" and "aids" yielded , entries; while a similar search for the terms "ethics" and "tuberculosis" yielded only . rather than reflecting difference in ethical importance, the disproportionate amount of bioethics attention to aids in comparison with tb reflects the fact that the former disease has affected an economically powerful and articulate community and has been much more highly politicized. the global tb status quo, meanwhile, is alarming. the world health organization (who) declared tb a global health emergency in . one third of the world population is currently infected with latent tb. approximately nine million people develop active illness each year, and "there are between million and million persons with active tuberculosis at any one time" (gandy and zumla , ) . though a cure for tb has existed for over years, and though in the s tb was believed to be eradicable, tb "is now more prevalent than in any previous period of human history" (gandy and zumla , ) . the tb burden is highest in asia, which accounts for two thirds of the global burden of tb (who b). the southeast asia region has the largest number of new incident cases, accounting for % of incident cases globally. the incidence rate in sub-saharan africa, however, is nearly twice as high-"at nearly cases per , population" (who b) . like most other infectious diseases, the burden of tb is most heavily shouldered by the poor: % of tb cases and % of tb deaths occur in developing countries (gandy and zumla ) . this is because the poor lack good nutrition, and this weakens their immune systems. it is also because crowded living and working conditions, and lack of sanitation and hygiene, increase chances of exposure and infection. because the poor so often lack access to (even inexpensive) medical care, they are more likely to suffer adverse outcomes when infection occurs. direct and indirect costs of illness can have a catastrophic effect on tb sufferers and their families (bates et al. ; jackson et al. ) . matters have been made worse by the growing hiv/aids epidemic. those living with hiv/aids are much more likely to contract tb, and more likely to develop severe illness when they do (harries and dye ) . though the impact of tb is most heavily felt in developing countries, the emergence and spread of multidrug-resistant tb (mdrtb) poses serious threats to developed nations as well. a primary cause of drug resistance is the failure of patients to always complete a full course of tb medication. this often occurs in developing countries when patients cannot afford to continue therapy, cannot afford time off work to visit health providers, or cannot afford travel to clinics. another cause of drug resistance is the weakness of health care infrastructures in poor countries. patients often fail to complete therapy because hospitals and clinics in poor countries fail to maintain a steady supply of standard tb medications (farmer ; farmer ) . drug resistance is also driven by the market presence of drugs that are low quality, old, or often counterfeit. like ordinary tb, drug-resistant tb is contagious. with increased global trade and travel, drug-resistant tb spreads frequently from country to country. though it is usually curable, mdrtb requires longer and more expensive treatment. ordinary tb can be treated with a six month course of medication costing us$ - . mdrtb takes two years to treat, and treatment can be up to times more expensive. the "second-line" medications used to treat mdrtb are, furthermore, both more toxic and less effective than the "first-line" drugs used to treat ordinary tb. the problem of untreatable tb is suddenly on the rise. in , the us centers for disease control and prevention (cdc) and who announced the emergence and spread of "extreme" or "extensively" drug-resistant tb (xdr-tb). mdrtb is defined as tb resistant to at least two (namely isoniazid and rifampicin) of the four first-line tb medications. xdr-tb is defined as tb resistant to at least two of the four first-line tb medications and at least two of the six second-line medications (a fluoroquinolone and an injectable agent; cdc ; who a). a recent study showed that % of tb isolates from around the world were mdrtb and that % of these were xdr-tb. xdr-tb was found in every region, and the study showed that isolates of mdrtb obtained from the usa, latvia, and south korea were, respectively, %, %, and % xdr-tb (cdc ) . the most dramatic epidemic of xdr-tb is currently underway in south africa. a study in march showed that % of suspected patients in tugela ferry were infected with mdrtb and that % of these had xdr-tb. of the patients with the latter, died within days (msf ) . many are worried that xdr-tb may "swiftly put an end to all hope of containing the [aids] pandemic [in africa] through treatment". according to one expert: "there is no point investing hugely in arv [anti-retro viral] programmes if patients are going to die a few weeks later from extreme drug-resistant tuberculosis" (boseley ) . implications of xdr-tb for the international community are starkly revealed by the cdc's conclusion that xdr-tb "has emerged worldwide as a threat to public health and tb control, raising concerns of a future epidemic of virtually untreatable tb" (cdc ) . bioethics research in the context of tb should address the following issues. a common topic in bioethics discussion of infectious disease has been the question of health workers' duty to treat patients infected with diseases that pose risks to health workers themselves. a related question concerns the duty of society, or the health care system, to provide safe conditions for health workers through provision of masks, room ventilation, and other infection control measures in hospitals and clinics. most of the debate has thus far focused on aids, sars, and avian influenza. the existing literature reveals that there are no simple answers to these kinds of questions and that different issues arise in the context of different diseases (reid ) . though these questions are pertinent to tb, given that it is highly contagiousand increasingly dangerous in the context of mdrtb and xdr-tb, and/or when health workers are living with hiv (cobelens )-they have in the specific context of tb received little if any dedicated discussion in mainstream bioethics literature. bioethics should examine the extent of risk involved with treating tb patients; the nature and extent of health care workers' "duties" to face such risks; possible means (and ethical justification) for reducing such risks through improvement of infection control in health care settings; and the propriety of rewarding health workers willing to face greater risks (savulescu, in discussion) and/or the propriety of compensating those who actually become infected on the job (university of toronto joint centre for bioethics ). a major topic of debate in the context of hiv/aids research has been the question of what should count as an ethically acceptable control arm in studies involving human subjects. most of the attention has focused on placebo controlled studies of mother-tochild transmission of hiv in africa. critics argued that these studies conflicted with the declaration of helsinki requirement that patients in the control arm of a study should receive the "best proven" or "best current" therapy for the condition in question (lurie and wolfe ) . others argued that it would have been too expensive to provide such treatment in developing world contexts-and that no harm was done because patients were denied no treatment they would have received if they had not participated in the studies (because the standard of care in poor countries was no treatment to prevent vertical transmission of hiv). given that the who has recently declared that the standard of care for mdrtb requires provision of second-line drugs, it will not be surprising, given what commonly occurred in the context of hiv, if there are proposals for studies where control arm subjects would not receive this expensive, high level of care (apparently) still required by the declaration of helsinki. would it be wrong to deprive control arm subjects of second-line drugs if they would not receive them if they did not participate in the study in question-given the poverty situation in the local context? how are the ethical issues in the context of tb similar to, or different from, those that arose in the context of hiv/aids? another issue arising in clinical research involves the management of third-party risks. a study of a new drug for resistant strains of tb, for example, may pose risks to third parties. if the investigational drug is not effective, then a patient-subject who receives it may remain infectious and thus endanger family members and other close contacts. isolation of the patient-subject or informed consent of third parties might thus be called for. this general issue has been neglected by research ethics guidelines (francis et al. ). there have been reports of prescription practices in poor countries where health workers decide to exclude tb patients from treatment in cases where it is believed that the patient is unlikely to complete therapy (singh et al. ) . while withholding treatment from unreliable patients may serve the aim to avoid promotion of drug resistance, a practice like this may be inappropriately discriminatory. such a practice may also have counterproductive results if infectious patients remain at large in the community. because the ability of health workers to make sound judgments about such matters is suspect, the extent and quality of institutional policy calling for patient exclusion warrants further analysis. in addition to concerns about unjust discrimination, a major question is whether or not, or why, it is reasonable to think that the harm to excluded individuals would be outweighed by greater goods to society in the way of public health. these are partly, though not entirely, empirical questions-i.e., about what the actual harms and benefits are (to individuals and society, respectively). the more ethico-philosophical question is how benefits to society should be weighed against harms to individuals. if there is a duty to do no harm, then infected-or potentially infected-persons have duties to avoid infecting others (harris and holm ; verweij ) . this interesting and important topic has received surprisingly little attention in general, and discussion to date has primarily focused on aids and influenza. bioethics should examine the extent to which a duty like this applies in the context of tb in particular. because it would be unreasonable to expect potentially infected persons to take all possible measures to avoid infecting others, appropriate limitations to the duty must be considered. because tb is transmissible via casual contact, anyone who has been breathed or coughed on by someone who might (for all one knows) be infected with tb should, epistemologically speaking, consider herself to be "potentially-infected". but that means almost all of us! (this is just one of the ways in which the case of tb is different from aids.) even those who actually have been in (limited) contact with someone sick with active tb, however, will usually not themselves become infected as a result. though potentially deadly and considered highly contagious, tb is not nearly so contagious as the flu. (this is just one of the ways in which the case of tb is different from flu.) to what extent should someone who knows she has been exposed to tb limit her interactions with others afterwards? the answer will partly depend on whether we are talking about ordinary tb, mdrtb or xdr-tb-if these details are known. in cases where a contagious patient fails to take adequate precautions to avoid infecting others-and fails to warn close contacts about his infectious status-then the question of whether or not the health worker should inform identifiable third parties at risk arises. on the one hand, notification of third parties about a patient's health status would breach the widely acknowledged patient right to confidentiality. on the other hand, failure to warn could (especially in the context of xdr-tb) conflict with the innocent third party's right to life-which many would say is more important than the incautious patient's right to confidentiality. this matter is complicated because a routine practice of breaching confidentiality may decrease trust in the health care system, reduce health-seeking behavior, and thus drive the epidemic underground. what the actual public health implications of third-party notification would be is an empirical question that warrants further study. mandatory tb testing in schools, the workplace, or elsewhere in the community may potentially conflict with the right to privacy. if information concerning the health status of individuals is not well protected, then stigma and discrimination will result. surveillance measures, on the other hand, are sometimes important to the protection of public health. bioethics should consider the extent to which current surveillance measures are-or the extent to which more wide-reaching surveillance measures would be-justified in the context of tb, especially now that mdrtb and xdr-tb are growing threats to global public health. it is common for countries to screen migrants for tb before granting entry visas. some have questioned the public health efficacy and/or cost-effectiveness of a practice like this in comparison with other means of tb control (coker ) . whilst identification of active disease offshore is a commonly used method for tb control in countries with a low prevalence of tb (and sometimes countries with high prevalence), it is not always possible to perform due to the lack of resources or a lack of time prior to arrival (coker ) . additionally, one-off screening for tb with x-ray does not completely eliminate the risk of tb transmission to the public in the receiving nation due to the lifetime latency of the disease (macintyre et al. ) . the offshore tb screening policy relies on a "user pays" philosophy, where visa applicants are responsible for the costs incurred. aside from questions of equity, where the poor who are most likely to have tb are also least likely to be able to pay for the screening tests, this model works well when a private sector health system is in operation. the international organization for migration (iom) has called for a "paradigm shift from exclusion to inclusion" to address this, amongst other unintended effects of premigration screening for the benefit of the migrant and the host nation (maloney ) . in many countries from which refugees are resettled, there are no private for-profit radiological or microbiological facilities and government clinics are stretched to capacity. is it appropriate for developed countries to shift costs for their public health onto the overburdened health systems of other, less well-resourced, countries? additional ethical issues arise in the context of asylum seekers. this form of migration has posed enormous problems in the northern hemisphere. in situations like this, host countries' duties of beneficence potentially conflict with duties to protect public health. ethical issues associated with migrant screening in the context of infectious disease are a generally neglected area of discussion that is becoming increasingly important in the contemporary era of "globalisation" and "emerging infectious diseases". these issues are especially pertinent in the context of tb. in the past, patients with infectious tb were isolated in sanatoria for prolonged periods-and sometimes even for life. this was done to protect others from infection. even today, in many countries, it is common to isolate patients with pulmonary symptoms (i.e., "active tb") until they are deemed uninfectious-usually about two weeks after therapy is started. such detention is usually brief and voluntary. it is common, however, to coercively confine patients with active tb, and sometimes patients with inactive tb, when they refuse to take their medicine or when it is believed they are unlikely to adhere to treatment regimens (coker ) . bioethics should consider the extent to which (coercive) restriction of movement is ethically justified in the name of public health protection against tb. of particular importance is the question of what should be done with xdr-tb patients, who pose threats of infection with an especially dangerous form of tb whether they take their medicines or not. defenders of confinement in the context of treatable tb sometimes suggest that confinement is justified when patients are at least given a choice between confinement and treatment-the idea being that this respects their autonomy (bayer and dupuis ) . if xdr-tb patients are confined because they are untreatable, then no autonomous choice would remain. though this does not go to show that mandatory confinement is therefore inappropriate, the point is that the question of what to do with xdr-tb patients is not automatically settled by conclusions about what to do with noncompliant patients with treatable tb. additional new questions are whether or not, the extent to which, or the conditions under which, it would be ethical to quarantine the large number of people exposed to, though not known to be infected with, xdr-tb-or those suspected, though not known, to be infected with xdr-tb (singh et al. )-while diagnostic confirmation is awaited. coercive long-term confinement may again become common in the case of patients actually diagnosed with (untreatable) xdr-tb. in a widely reported case in arizona, for example, an xdr-tb patient has been detained in a prison hospital for over a year (democracy now ) . and there are already calls in africa for a return to compulsory sanatoria for such patients (sakoane ) . if the spread of untreatable xdr-tb becomes sufficiently alarming, we may be faced with quarantine and confinement at a scale not seen for decades. in a patient suspected of infection with xdr-tb was subjected to the first us federal isolation order since . among other questions, the following should be further considered: ( ) the extent to which coercive social distancing measures are justified in light of the available evidence (or lack thereof) regarding their efficacy and ( ) arguments calling for compensation provision to those whose liberties are coercively restricted. it is true that untreatable tb was the norm prior to development of cures in the middle of the th century, and we should examine historical debates regarding the social acceptability of confinement and so on that took place in public health circles in the pre-antibiotic era. no developed discipline of bioethics existed at that time, however, and so it remains to be seen how policy decisions made then will be viewed under the lens of rigorous ethical analysis. more importantly, given population growth and globalization, the contemporary world is different from that when untreatable tb previously existed. because population dynamics have changed, there is no reason to assume that public health solutions to untreatable tb in the past (even if it is determined that such policies were ethically and epidemiologically sound at the time) will be appropriate to the contemporary world. as indicated above, it is commonly the case that (treatable) patients are required to either undergo therapy or be held in confinement. insofar as the threat or actual use of force is involved, tb treatment involves coercion and thus conflicts with individual autonomy (despite the fact that patients are usually given at least some choice in the matter). the worldwide standard of care for tb treatment is known as directly observed therapy, short course (dots). among other things, dots involves health or social workers' observation of patients' medication-taking; and patient cooperation is (often) part of what is required to avoid detention. though dots has (arguably rightly) been hailed as a great success in global tb control (partly because it promotes patient "compliance" and thus helps prevent drug resistance) ethical issues are raised by the coercion involved. it is generally thought that informed consent to medical treatment is important-and that it must be voluntary. autonomy, however, may be outweighed by societal benefits if the stakes are sufficiently high. additional issues involve threats to privacy and dangers of stigmatization in contexts where dots practices are visible to the community; and the costs/ inconvenience of dots in comparison with unmonitored treatment (especially when we are talking about reliable patients). though issues associated with mandatory treatment and dots have perhaps received more bioethics attention than others considered in this chapter, much of the debate to date has focused on the limited context of new york city in the s and s (see bayer and dupuis and reference therein) . coercion is also involved in attempts to remove mycobacterium bovis ("bovine tb") from the food supply in rich countries by culling infected herds and pasteurizing milk. in part this is done to increase the safety and value of bovine (or ovine and other herbivore) products, especially milk and cheese. in poor areas of the world with ongoing high rates of tb among cattle or buffalo and use of raw milk products, bovine tb still causes much disease among humans, usually as an extrapulmonary infection of the throat (scrofula), stomach, abdomen or bones. although control of animal tb may seem to be of obvious benefit to a community, the affected farmers may object to testing and culling of their infected animals, even when paid compensation, if herds cannot easily be replaced with disease-free equivalents. also, farmers may be emotionally attached to the animals, especially dairy cattle, the main target for control of bovine tb. another issue arises with compulsory pasteurization of milk. some people even break the law to exercise their "right to consume natural products". how important are these liberties-and are they outweighed by public health benefits requiring coercion? again these are, but only partly, empirical issues. as a disease of poverty, tb raises issues of international distributive justice. though sufficient resources for health improvement are lacking in poor countries, there are numerous powerful moral (egalitarian, utilitarian, and libertarian) and self-interested reasons for wealthy nations to do more to help improve health care in poor countries (selgelid onlineearly ) . these issues are complex and intertwined with the above questions regarding liberty violating public health measures. if health care provision and thus global health were better to begin with, for example, then the occasions upon which liberty infringing public health measures are called for would arise less often. in addition to improving access to existing medications, increased r&d for drugs and diagnostics is sorely needed in the fight against tb. at present, "[w]orldwide only $ million is spent annually for clinical trials for tb drug[s] compared to around $ million for hiv drugs in the us alone" . bioethicists should debate recent proposals (pogge ; kremer and glennerster ) and current activities (moran et al. ) aimed at stimulating r&d on neglected diseases-and the extent to which they are apt for tb in particular. they should also examine the extent to which targeted funding for tb control is warranted in comparison with other infectious diseases. because it has been argued that donor aid should aim to improve developing countries' general health care infrastructures-and improvement of general health indicators-rather than targeting particular diseases such as aids and tb (garrett ) , the propriety of targeted tb funding should be evaluated. because infectious diseases, including drug-resistant infectious diseases such as xdr-tb, fail to respect international borders, bad health in poor countries threatens global public health in general. the strength of associated self-interested reasons for wealthy nations to help reduce tb in poor countries (through targeted or untargeted funding) should therefore, finally, be a major focus of analysis. our recommended approach to ethics and infectious disease may be characterized as "moderate pluralism". this approach aims to identify the plurality of (intrinsic) values at stake in the context under study and strike a balance between potentially conflicting values without giving absolute priority to any one value in particular. in the context of xdr-tb, for example, the utilitarian aim to promote public health might best be promoted through coercive confinement of infected patients. such a policy, however, would conflict with apparent rights and liberties of infected individuals; and it is not generally believed that individual rights and liberties should be sacrificed whenever this would promote the greater good of society. resolving a conflict like this requires assessment of the overall threat to society, assessment of the centrality/importance of the rights under threat, and consideration of features that might make one value (i.e., utility) or the other (i.e., liberty) especially important in the context in question. most ethicists, policymakers, and ordinary citizens would, upon reflection anyway, deny that either of these two social values should always be given absolute priority over the other. the ideal solution to conflict between values is to bypass the conflict to begin with. we should thus, whenever possible, aim for a policy that promotes both utility and liberty-and also equality, another legitimate social value-at the same time. tb reduction via increased health care provision would reduce the frequency of occasions where we are faced with the conflict between utility and liberty under consideration; and it would likely also promote equality (given that tb reduction would generally involve improving the situation of those who are worst off). this is not to say that the initially considered conflict would never eventuate if tb reduction occurs. difficult decisions will need to be made in cases where conflict is unavoidable; and a principled rationale for favoring one value over another is needed in cases of conflict. one idea is that the aim to promote utility should be weighted more heavily as a function of the extent to which utility is threatened. another idea is that the weight of a right/liberty should be weighted as a function of its centrality. more basic rights/liberties deserve more protection than others. when catastrophe would result from protection of the most basic rights, however, then even these must be compromised. we sometimes think it is appropriate to violate the most basic right of all-i.e., the right to life in time of war. when rights violations are found to be necessary in the context of tb, amends can be made by compensating individuals whose rights are compromised (ly et al. ). the living conditions of those confined should be made as comfortable as possible-and those who succumb to liberty restrictions should perhaps receive additional (e.g., financial) rewards. it would be unfair to expect coerced individuals to shoulder the entire cost of societal benefit. 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south africa: back to tb sanatoria perhaps? affordable access to essential medication in developing countries: conflicts between ethical and economic imperatives ethics and infectious disease improving global health: counting reasons why . ethics and infectious disease xdr-tb in south africa: no time for denial or complacency tb control, poverty, and vulnerability in delhi are there characteristics of infectious disease that raise special ethical issues? patents and access to drugs in developing countries: an ethical analysis taking sociology seriously: a new approach to the bioethical problems of infectious disease aids epidemic update stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza obligatory precautions against infection the stop tb strategy. geneva, world health organization. who global tuberculosis control: surveillance, planning, financing. who report. geneva, world health organization we thank the brocher foundation in hermance, and the institute for biomedical ethics at the university of geneva, in switzerland, for hosting the lead author as a visiting researcher during the period this chapter was written. key: cord- -repm vw authors: ungchusak, kumnuan; heymann, david; pollack, marjorie title: public health surveillance: a vital alert and response function date: - - journal: the palgrave handbook of global health data methods for policy and practice doi: . / - - - - _ sha: doc_id: cord_uid: repm vw ungchusak, heymann and pollack address the critical global issue of public health surveillance. they describe how epidemiologists collect and use surveillance data to detect unusual events or outbreaks and to guide control programmes. drawing on their combined international experience, the authors explain the vital role that data play in alerting authorities to respond to outbreaks such as severe acute respiratory syndrome, ebola, zika virus and avian influenza. they point to the importance of sharing information globally while ensuring equal benefits to providers of data, coordinating surveillance activities across sectors, building capacity for surveillance and coordinating national surveillance activities. the authors emphasise the need for enhanced global cooperation to prepare for future public health emergencies of international concern. a three-month delay in identifying the outbreak of ebola virus in rural guinea in late resulted in its rapid spread to urban areas and to neighbouring liberia and sierra leone [ ] . once local and international responders identified the virus, they took a year to interrupt its widespread transmission. by april , ebola had accounted for more than , cases and over , deaths. people around the world watched with increasing alarm, as this tragic course of events played out, and with concern that air travel could enable the virus to spread across continents. this epidemic highlighted not only the inadequacy of local health systems to recognise and respond but also that international organisations were not ready to provide timely expertise and resources to control the situation and ameliorate the virus's spread through the region. had health officials identified ebola in west africa promptly, they could have minimised its impact on the lives and livelihoods of the populations of west africa by implementing appropriate control procedures. public health officials coined the term surveillance to describe systems they set up to watch out for and control occurrence of health threats. just as police, for example, set up closed-circuit television devices and community watch programmes to detect and prevent crime, public health surveillance systems engage all possible means to detect unwanted health events and prevent them from escalating and damaging population health. while public health surveillance originated to control spread of infectious diseases such as plague and cholera, it has evolved to include some non-communicable diseases, occupational health and injuries as well as surveillance of biological, behavioural and social determinants of these conditions. we start by reviewing the public health need for surveillance and the development by the international community of regulations to control infectious diseases and other public health emergencies of international concern (pheic). we describe how epidemiologists use surveillance data to detect unusual events or outbreaks and to guide control programmes, and we provide guidance about maintaining data quality. we examine networks that contribute to global surveillance systems and highlight the role of social media and information technology in providing data to monitor new events of international importance. we consider challenges facing epidemiologists responsible for surveillance and describe efforts to address them. public health surveillance is vital to the functioning of national and global health systems. policymakers and health administrators need surveillance information to set priorities to address population health problems, allocate resources and monitor progress of prevention and control programmes; they need surveillance systems to alert them immediately of public health threats. emerging infectious diseases, such as avian influenza of different subtypes, severe acute respiratory syndrome (sars) coronavirus, pandemic influenza h n and the zika virus (zikv) have the potential to spread rapidly causing severe loss of life and to impact socio-economic activity, especially trade and travel [ ] . the outbreak of sars in november highlighted the importance of every country having functioning and connected surveillance systems (see box . ). surveillance requires high-level government support, well-trained health workers, strong health information systems, well-functioning laboratories, effective communication systems and operational health facilities. to be effective, surveillance systems also require a strong legal framework to ensure that individual data can be shared while maintaining confidentiality as far as possible. global cooperation between countries, with up-to-date international health agreements to build and maintain these capacities, is essential to decrease risk of international spread of infectious diseases and contain the risk of bio-terrorism. sars originated in wildlife and spread silently among humans as atypical pneumonia in guangdong province, china, two months before officials became aware of it. authorities began surveillance to identify atypical pneumonia cases but this, and the containment response, were too late to stop sars spreading. a chinese urologist who was infected travelled to hong kong and spread sars to another persons. within weeks, sars spread to countries with more than , reported cases ( fig. . ) [ ] . by the end of the epidemic in july , sars had killed people [ ] . although unable to contain the outbreak of sars, the international community was able to bring the epidemic under control within six months-by collaborating across countries to identify and isolate all probable cases. nevertheless, the asian development bank estimated that the economic loss due to sars in affected countries was up to us $ billion with us$ . billion on mainland china (approximately . per cent of its annual gross domestic product (gdp)) and us$ . billion in hong kong (approximately per cent of its annual gdp) [ ] . plague ravaged europe during the fourteenth century and although authorities had no cure, they realised it was important to swiftly identify and isolate cases to prevent and control this lethal condition. authorities understood that international spread of such diseases followed cross-border trade, pilgrimage and war; and so prevention of disease was a national security issue. in the city-state of venice, authorities instigated quarantine measures-keeping arriving ships in the harbour for days before docking, and holding people in isolation for days at land borders to prevent entry of plague [ ] . in the mid-nineteenth century, recognising that quarantine measures were not enough, governments agreed international conventions aimed at stopping spread of plague and cholera-and two other infectious diseases, yellow fever and smallpox. the conventions required each country to report outbreaks of these diseases to all signatories of the convention, and permitted application of certain public health measures at international borders once a country reported of one of the diseases. in the early twentieth century, governments in the americas and in europe set up regional conventions called international sanitary bureaus. in , the newly formed world health organization (who) led establishment of the international sanitary regulations (isr) to foster global cooperation in reporting and acting at international borders to guard against spread of cholera, plague, yellow fever and smallpox. in , the who replaced the isr with the international health regulations (ihr) which required countries to report any cases of cholera, plague, yellow fever and smallpox to who [ ] . if a country reported one of these diseases, other countries could apply pre-established control measures at international borders-such as a requirement of proof of vaccination against yellow fever of any passenger arriving from a country that reported yellow fever to who. some countries reported to who late, or not at all, because of lack of capacity for public health surveillance, or because of fear of stigmatisation and economic repercussions. after hiv spread across international borders before being identified in , the international community realised that infectious diseases could not be stopped at borders. diseases often cross borders while still being incubated in humans, or in non-human hosts-insects, animals, and food and agricultural goods. in , after the sars outbreak, who updated and revised the ihr as a legal framework to include more diseases, and developed real-time evidence-based recommendations for prevention and control of outbreaks. who evaluates each newly identified outbreak for its potential to become a pheic by the country in which it is occurring. the ihr mandate who member countries to report immediately the occurrence of a single case of four diseases (smallpox, poliomyelitis due to wild type poliovirus, human influenza caused by a new subtype, and sars) [ ] . even though the world eradicated smallpox in , the ihr still maintain it on the list to cover the risk of the virus escaping from a laboratory. each country has an additional list of diseases that it requires its health workers to report by law. diseases of greatest public health threat are reportable, meaning that health workers or laboratory technicians must report individual cases as they occur. reportable diseases include those required by ihr and, for example, anthrax, cholera, ebola, legionellosis, plague and the zikv. other conditions are notifiable, meaning that health workers should report the number of cases that have occurred in a given time period. the number, frequency of reporting and breakdown of reportable and notifiable diseases varies by country. diarrheal cases, influenza cases, tuberculosis, aids and other significant endemic diseases are usually required to be notified to local health authorities. in some countries the notifiable list can include non-infectious conditions such as maternal or infant deaths. the ihr require countries to develop core capacities in public health, including surveillance systems and epidemiology services, that can analyse and act on surveillance information to detect and respond to diseases where and when they occur so that their potential to spread internationally is decreased. the purpose of surveillance activities is to: ( ) detect at an early stage, acute public health threats from all hazards-biological, chemical, radiation, natural disaster and deliberate acts-which require rapid investigation and response; and ( ) guide control programmes by measuring disease burden, monitoring trends, describing disease distribution and evaluating public health programme effectiveness (see table . ). the structure of government responsibilities for public health surveillance varies across countries. most often, countries set up dedicated early warning and rapid response surveillance teams that work with or complement surveillance activities of vertical control programmes such as malaria, hiv/aids or tuberculosis. surveillance and response teams detect early stage public health threats while control programmes gather disease (or condition) specific information to plan activities. control programmes share information with surveillance teams as required. a national network of public health laboratories, often linked to international reference laboratories, confirms etiologic agents, genetic strains and antibiotic resistance patterns. surveillance activities are said to be active when health workers pro-actively seek out cases and passive when the system relies on patients to report themselves to a clinic. using standard case definitions, health workers report individual cases of reportable and notifiable diseases to the local or national surveillance centre where staff aggregates reports, and clean and analyse the data. in cleaning the data, staff look for coding and classification errors, and for duplicate reports. epidemiologists analyse the data to determine how many new cases have occurred during the past day or week and their distribution in time, place and by person to see whether the magnitude and pattern of the disease under surveillance is changing. they note any changes in frequency, clustering or distribution and flag them for verification and explanation. box . illustrates how careful data analysis led to malaysia identifying nipah virus in [ ] . reporting of specific information about cases or patients or behaviour of populations under surveillance produces indicator-based data, that is individual or aggregated data derived from patients diagnosed-by syndrome description, clinical or laboratory confirmation-and identified through routine collection or active case search. the surveillance unit will also use eventbased data about outbreaks, unusual events or changes in human exposure [ ] . rather than wait for official reports, the surveillance team gathers information and rumours through the media, internet and unusual events reported by the community, and investigates these reports. the team captures abnormal health events in real-time and confirms potential outbreaks by triangulating these data with indicator-based data. epidemiologists responsible for surveillance use standard epidemiological methods to analyse trends, identify clusters and investigate suspected risk factors (see chap. for an overview of epidemiological methods). for example, high numbers of reported cases of kaposi sarcoma among young men in new york and california during the early s led to an investigation which showed a japanese encephalitis commonly occurs in school-age children of both sexes. there is a seasonal pattern of disease related to the rainy season when transmission and therefore disease occurrence, increases; there is no difference in occurrence between ethnic or religious groups. from september to april , surveillance teams sent reports of cases of febrile encephalitis ( per cent fatal) to the malaysian ministry of health [ ] . initially, the ministry considered japanese encephalitis virus to be the probable etiologic agent for this outbreak, and instituted conventional interventions of vaccination and insecticide to control mosquitoes. when they examined the surveillance data closely, the epidemiological pattern of encephalitis cases was different to what they expected-the disease occurred mostly among male adults of chinese ethnic origin whose occupations related to pig farming. the ministry sought a different cause and found the etiologic agent to be a new paramyxovirus, later named nipah virus. common risk factor of homosexual behaviour and its relationship with hiv/ aids [ ] . using increasingly sophisticated technologies for data capture and analysis, surveillance teams can monitor real-time occurrence, in time and place, of unusual events such as cholera or legionella, or seasonal outbreaks such as malaria (see chap. for an introduction to spatial and spatio-temporal techniques and to chap. which discusses predicting climate-related health outcomes such as malaria). once epidemiologists have concluded their analyses (sometimes in realtime), they prepare reports which can trigger immediate action by a rapid response team to visit the site of the events, investigate the situation and contain the outbreak. the team also sends reports to clinicians in hospitals and to local and national programme managers. many countries publish weekly disease surveillance reports that are also available to the general public: for example, the us centers for disease control and prevention (cdc) publish the morbidity and mortality weekly report (mmwr) [ ] , the european centre for disease control (ecdc) publishes eurosurveillance [ ] , and the who publishes the weekly epidemiological record [ ] . box . shows how epidemiologists associated microcephaly with zikv which led who to declare zikv a pheic [ ] . public health surveillance guides control programmes by undertaking the following functions: in late , zikv spread rapidly through latin america especially in brazil and el salvador. surveillance of birth defects in brazil identified a major increase in microcephaly during the period when zikv transmission increased. this alerted policymakers and epidemiologists to study whether the increase in birth defects was associated with zikv infection during pregnancy. who declared the suspected increase in microcephaly in association with zikv infection of pregnant women a pheic and recommended pregnant women to protect themselves from mosquito bites and to avoid travel to areas with known zikv transmission. the observation that men who travelled to areas with known zikv transmission could sexually transmit zikv to their partners led who to recommend practising safer sex or abstinence for a period of six months for men and women returning from areas of active transmission. its epidemiological patterns disease in humans results from interactions between the human host and causative agents or hazards of all types. the natural and socio-economic environment influences these interactions. diseases usually occur in the same pattern when there is no change in the causative agent (such as mutation), in the human host (such as vaccination) or in the environment (such as climate change). a surveillance system can closely monitor any changes in these dynamic factors and their consequences, as illustrated by the case of nipah virus in malaysia (box . ). public health surveillance must also address risk. for example, surveillance of annual per capita cigarette consumption in the us showed an increased trend from cigarettes in to , cigarettes in . researchers related this trend to advertising and an expansion in the number of cigarette companies. in , after the first studies suggesting cigarette consumption was related to lung cancer, and the us surgeon general issued a warning, the annual per capita consumption decreased to , [ ] . with surveillance information, epidemiologists can forecast an increase in lung cancer without intervention thereby providing evidence for policy to implement effective interventions such as taxation to prevent smoking. evaluating performance of control programmes after they have implemented interventions, health authorities use surveillance data to see if disease incidence declines. for example, when vaccine coverage increases, the number of cases of vaccine preventable diseases is expected to decrease. increasing taxes on cigarettes is one way to reduce consumption. surveillance data can document a correlation between increasing taxes and decreasing trends in cigarette consumption. to achieve these functions, programme managers collect data through patient records, surveys, programme records or informal sources. types of data include determinants of the condition, behaviours or risk factors associated with the condition, morbidity and mortality associated with the condition, programme responses, and abnormal or unusual events associated with the condition. table . provides examples of these types of data for surveillance of an hiv/aids control programme. to ensure surveillance programmes have adequate resources and produce useful information, public health authorities regularly review their surveillance activities. in , the us cdc issued guidelines to evaluate surveillance systems which, with some updating, are still widely used [ ] . these guidelines focus evaluation of public health surveillance on three areas: ( ) the surveillance system itself, describing the system, its structure, diseases under surveillance, sources of data, and how data are processed, analysed and disseminated; ( ) the resources used to operate the system, including funding sources, adequately trained staff and information technology; and ( ) the usefulness and quality of surveillance information, using the following indicators: usefulness of data do the data and information disseminated to data providers and users contain comprehensible facts and findings and useful recommendations to improve control measures and guide programme management? has the system detected outbreaks? how many of the detected outbreaks were investigated and controlled in a timely manner? timeliness of data and other information is data dissemination timely and regular? for example, epidemic prone diseases require weekly summary, while other diseases require only monthly or quarterly summaries. are these requirements met? validity and completeness of data much of the data come from clinical diagnoses that do not have laboratory confirmation. it is useful to conduct studies to determine the accuracy of diagnoses using standard laboratory confirmation testing. this helps in preparing estimates of the proportion of confirmed cases among all reported cases. when undertaking field investigations, investigators can compare the number of actual cases they find with the number of cases reported through the system. this provides an estimate of reporting completeness of the system. global public health surveillance is the collection, analysis and use of standardised information about health threats or their risk factors from more than one country, and usually worldwide. while surveillance mainly focuses on infectious diseases, global systems also seek to identify deliberate use of biological agents or toxins to cause harm. who leads the global public health surveillance system, gathering information from formal and informal sources working through its country and regional offices. who extends its reach through the global outbreak and response network (goarn) [ ] which comprises over national technical institutions that support who to detect public health threats and respond to outbreaks. who uses the information for risk assessment and analysis as part of its routine disease control and prevention programme activities. when requested by countries for support, who works with goarn institutions to recruit suitable experts. goarn includes regional networks of countries that cooperate independently to prevent and control infectious diseases occurring in their regions, for example, the east african integrated disease surveillance network (eaidsnet), [ ] and the mekong basin disease surveillance network (mbds) [ ] . who leads global networks that work to control specific diseases. these networks depend on cooperation of governments, public health workers and scientists to report cases, provide specimens and share information so that specific diseases can be controlled globally. these include: networks to support influenza control through vaccine development the global influenza surveillance and response system (gisrs) consists of national sentinel centres and national and regional laboratories which annually collect , - , nasal swabs from patients presenting with influenza-like illness. their analyses provide information about the distribution of strains circulating each year and enable scientists to recommend the influenza vaccine composition for the following year based on predominant sequences. gisrs also uses flunet, a public web-based data collection and reporting tool that tracks movement of influenza viruses globally and provides epidemiological data about influenza outbreaks [ ] . initiative. clinical health workers and epidemiologists report all cases of acute flaccid paralysis (afp) in children under years of age from whom they have collected stool specimens for isolation and identification of the poliovirus. through its network of national, regional and specialised laboratories, gpln determines whether polio was the cause of the afp, genetically sequences viruses and compares them to a global database to understand their geographic source. if a polio virus is found, gpln informs the national authority and who regional office for appropriate action. project on anti-tuberculosis drug resistance surveillance [ ] is a common surveillance platform to which countries can provide data that are then used to monitor the evolution and spread of multi-drug resistant tuberculosis (mdr-tb) and extensively drug-resistant tuberculosis (xdr-tb). national laboratories provide susceptibility testing of tuberculosis organisms collected from patients, supported by a supranational tuberculosis reference laboratory network. the global project provides understanding of the prevalence and distribution of tuberculosis resistance worldwide. [ ] . its goal is to develop a standardised strategy to collect, analyse and share clinical, laboratory and epidemiological data globally, assess the burden and support local, national and global strategies to control amr. until recently, surveillance systems depended on paper-based reporting, compilation and analysis of data. computers and electronic reporting have made compilation and analysis of data much easier, and the world wide web (www) and the internet improve the comprehensiveness of reporting. digital and internet-based technology can retrieve information from medical records on a daily basis-but this must be done without infringing personal privacy. hospitals, especially private ones, may refuse to provide patient information to the public health sector unless privacy issues are addressed. cell phone technology has extended the scope of informal and event-based surveillance while social media has transformed exploring rumours of new events. some ground-breaking examples of the use of information and communication technology include: electronic reporting of events the programme for monitoring emerging diseases (promed-mail) is a fully moderated internet-based listserv, that receives and publishes reports of public health events in humans, animals, wildlife and plants from its subscribers and other traditional and nontraditional information sources [ ] . promed-mail uses information available on the www and from voluntary listserv reporters who actively search for and report public health events in realtime from the media, internet blogs and other sites. promed-mail editors and expert moderators review, analyse, evaluate and where possible validate reports, and then disseminate them to listserv members and post them on its website. using big data to identify events the subscription-based application global public health intelligence network (gphin) continuously scans the www gathering information from multiple source news aggregators in real-time [ ] . gphin searches in nine languages for key words that could indicate infectious disease outbreaks, or environmental, radioactive and natural disasters. analysts identify new events and inform subscribers-who are governmental and non-governmental agencies with an established public health mandate. every hours, analysts communicate new information to who which validates reports through its network of regional and country offices. who discusses events that it validates in confidence with health departments in the countries involved. mapping events in real-time healthmap, a fully automated application, utilises online informal sources for disease outbreak monitoring and real-time surveillance of emerging public health threats [ ] . healthmap trawls www sources of information (in nine languages) including online eyewitness reports, expert-curated discussions such as promed-mail, validated official reports, for example from who, or the food and agriculture organization of the united nations, and news aggregation services such as google news. using open source software, healthmap displays the events by time, geographic location and aetiology. participatory flu tracking diseases and abnormal events happen all the time in the community. only some patients, especially those presenting with severe disease manifestations, seek medical care. flu near you invites anyone living north america, over years of age, to report if they have an influenza-like illness [ ] . once registered, participants are asked weekly by e-mail to complete a brief survey that seeks information on ten symptoms linked to influ-enza, and other information such as whether or not the registered participant has had an influenza vaccination. other countries, including the uk, have adopted similar participatory influenza surveillance systems, thereby adding a greater understanding of the epidemiology of influenza around the world. participatory onehealth disease detection (podd) chang mai university in thailand, with support from the skool foundation, developed this mobile application which connects volunteers in local governments. when volunteers notice an abnormal event such as poultry dying off or sickness in animals or humans, they use podd to notify local authorities who dispatch a surveillance and rapid response team to investigate and contain the event. after months of implementation, podd has enabled the detection of , abnormal events, including chicken high-mortality outbreaks, four cattle disease outbreaks, three pig disease outbreaks and three fish disease outbreaks, all of which were detected and controlled [ ] . since revision of the ihr in , outbreaks due to infections, including the middle east respiratory syndrome coronavirus and ebola virus, have highlighted continued weaknesses in public health surveillance and response capacities in most countries, with international spread causing disruptions in trade and travel, and negatively impacting economies. we present some challenges and suggest some solutions. most countries have established disease control programmes each with a surveillance component reporting from grassroots through provincial and national levels. national surveillance units may have sufficient staff for each disease control programme, but at lower levels of the health system, the same individuals often manage more than one programme and are heavily burdened by reporting requirements. there is also duplication of effort in reporting between programmes. who supports countries to coordinate surveillance activities across departments, programmes and administrative levels through integrated disease surveillance and response (idsr) [ ] . idsr links surveillance with other health information activities and strengthens overall capacity of countries to maintain public health surveillance. the ihr obligates countries to develop comprehensive disease surveillance, detection and response when and where infectious diseases and other acute public health threats occur. in reality, national surveillance capacity in many countries is still not at expected and necessary levels. this may be, as the ebola epidemic demonstrated in west africa, that health systems are weak and under-funded, or that the surveillance system itself does not function efficiently. regular evaluation of the system, as we describe in sect. . , can identify which components need to be strengthened. an over-riding issue is for the system to deploy and maintain enough professionals throughout the system with the required skills-understanding the nature and limitations of the data they are working with and able to interpret and draw important findings from the analyses of the surveillance data. approximately per cent of newly identified human diseases are zoonotic in origin [ ] and per cent of these diseases have their origins in wildlife [ ] . since the outbreak of h n avian influenza in hong kong, animal surveillance and human surveillance units have begun to share information and alert each other of unusual events. environmental factors are also crucial to disease occurrence, for example, paralytic shellfish poisoning among people who consume shellfish affected by harmful algae growth in the sea [ ] . the one health approach involves sharing information between multiple health sectors and working together to identify and resolve outbreaks [ ] . during the avian influenza outbreak, who requested all affected countries to share the virus isolated from humans for further study and vaccine development. some governments expressed concern about potential negative economic consequences of sharing information and about possible inequities in the benefits of sharing. this led to the jakarta declaration on responsible practices for sharing avian influenza viruses and resulting benefits [ ] . this declaration underlined need for continued open, timely and equitable sharing of information, data and biological specimens related to influenza; it also emphasised need for more equitable sharing of benefits for example in the generation of diagnostics, drugs and vaccines. the jakarta declaration led to the pandemic influenza preparedness framework (pip) under which manufacturers of influenza vaccines, diagnostics and pharmaceuticals that use gisrs information make annual financial contributions to who. who uses approximately per cent of these contributions for pandemic preparedness activities and surveillance, and per cent for pandemic response including purchase of vaccines and antivirals at the time of a pandemic for countries without access to these supplies. in may , the chatham house centre on global health security, after a series of roundtable consultation with experts in public health surveillance, produced a guide on strengthening data sharing for public health surveillance. this guide facilitates both informal and formal data sharing. the guide proposes seven principles: building trust; articulating the value; planning; using quality data; understanding the legal context; coming to agreement; and evaluating. the guidelines help create the right environment for data sharing and to facilitate good practice in addressing technical, political, ethical, economic and legal concerns that may arise. the guidelines aim to ensure, to the greatest extent possible, that any benefits arising from use of the data are shared equitably [ ] . similar to clinical or public health practice, institutions or agencies responsible for public health surveillance need a set of ethical principles to guide their operations. the who guidelines on ethical issues in public health surveillance proposed guidelines [ ] . these guidelines fall into three major groups: first, the mandate and broad responsibility of the agency to undertake surveillance and subject it to ethical scrutiny; second, the obligation to ensure appropriate protection and rights of individuals under surveillance; and third, considerations in making decisions about how to communicate and share surveillance data to pursue common good and equity of population without harm to individual. the west african ebola outbreak provided a costly lesson that policymakers must commit to establishing, maintaining and advancing public health surveillance systems to protect and promote population health. to prepare for the next major outbreak, the world needs to invest in a strong warning and response system led by a global institution with sufficient authority and funding to react swiftly [ ] . who serves this role but is chronically underfunded. similar investment is needed in countries where a fully supported, well-functioning surveillance office or programme must coordinate different components of the surveillance system. surveillance information should be disseminated widely to alert the public and health programmes of outbreaks so that they can contain the disease at source before it spreads internationally. because the world urgently needs reliable and timely surveillance information, public health surveillance should continue to make innovative use of new technology to gather and share information strategically and fairly. • the ebola outbreak highlighted inadequacies of national and global surveillance systems to detect and respond to public health threats. • surveillance provides critical data and information to guide, improve and protect public health. • more trained staff are needed for effective and efficient surveillance especially in low-and middle-income countries. • innovative use of information technology and social media can aid detection of public health threats. one year into the ebola epidemic: a deadly, tenacious and unforgiving virus: world health organization emerging infectious diseases in . years after the institute of medicine report. mbio sars molecular epidemiology: a chinese fairy tale of controlling an emerging zoonotic disease in the genomics era the legacies of sars -international preparedness and readiness to respond to future threats in the western pacific region. western pacific surveillance and response journal sars economic impacts and implications. economic and research department policy brief no . asian development bank lessons from the history of quarantine, from plague to influenza a. emerging infectious diseases world health organization. the international health regulations world health organization early detection, assessment and response to acute public health events: implementation of early warning and response with a focus on event-based surveillance: interim version who/hse/gcr/lyo/ . world health organization world health organization. who director-general summarizes the outcome of the emergency committee regarding clusters of microcephaly and guillain-barré syndrome achievements in public health, - : tobacco use-united states updated guidelines for evaluating public health surveillance systems the global outbreak alert and response network. global public health east african integrated disease surveillance network mekong basin disease surveillance network global polio laboratory network world health organization. surveillance of drug resistance in tuberculosis global anti-microbial resistance surveillance system (glass) epidemic intelligence -systematic event detection podd: an innovative one health surveillance system preventing pandemics with animal origins training programs in epidemiology and public health interventions network risk factors for human disease emergence global trends in emerging infectious diseases woods hole oceanographic institution. harmful algae one health initiative. one health initiative will unite human and veterinary medicine jakarta declaration on virus sharing: a strategic step to more equitable and affordable avian flu vaccines distribution a guide to sharing the data and benefits of public health surveillance. london (uk): the royal institute of international affairs chatham house world health organization. who guidelines on ethical issues in public health surveillance the next epidemic-lessons from ebola key: cord- - fpx pxs authors: corless, inge b.; nardi, deena; milstead, jeri a.; larson, elaine; nokes, kathleen m.; orsega, susan; kurth, ann e.; kirksey, kenn m.; woith, wendy title: expanding nursing's role in responding to global pandemics / / date: - - journal: nurs outlook doi: . /j.outlook. . . sha: doc_id: cord_uid: fpx pxs nan inge b. corless, phd, rn, fnap, faan a, *, deena nardi, phd, pmhcns-bc, faan a , jeri a. milstead, phd, rn, nea-bc, faan a , elaine larson, phd, rn, faan, cic b , kathleen m. nokes, phd, rn, aphn-bc, faan a , susan orsega, msn, fnp-bc, faanp, faan a , ann e. kurth, phd, rn, cnm, mph, faan a we know by now that the world will see another pandemic in the not-too-distant future; that random mutations occur often enough in microbes that help them survive and adapt; that new pathogens will inevitably find a way to break through our defenses; and that there is the increased potential for intentional or accidental release of a synthesized agent. every expert commentary and every analysis in recent years tells us that the costs of inaction are immense. and yet, as the havoc caused by the last outbreak turns into a fading memory, we become complacent and relegate the case for investing in preparedness on a back burner, only to bring it to the forefront when the next outbreak occurs. the result is that the world remains scarily vulnerable.-world bank, the world is interdependent, not only in terms of the flow of human beings but also the spread of new, emerging, and re-emerging pathogens (eidr). the number of outbreaks per year has tripled in the last several decades (smith et al., ) and the human and economic impact of human immunodeficiency virus, severe acute respiratory syndrome, ebola, and other diseases, has been staggering. yet only a handful of countries have carried out pandemic preparedness exercises (world bank, ) . furthermore, funding for pandemic preparedness (e.g., the coalition for epidemic preparedness innovations and the bloomberg foundation), has been led by nongovernmental donors more than by governments. global preparedness is critical and must include strengthening global surveillance in public and other health care delivery systems. communities must be engaged as active partners in primary and secondary infectious disease prevention efforts. as the largest cadre of the health workforce in every country, as well as a profession that is dedicated to prevention and alleviation of suffering, nurses must be integrally involved with interprofessional teams, communities, and across sectors for global pandemic preparedness. infectious diseases constitute the third leading cause of death worldwide (who, ) . international mobility contributes to the promulgation of new and reemerging pathogens that frequently are resistant to current form of treatment (morens & fauci, ) . this mobility may result in disease outbreaks that have dire consequences. emerging global pandemics pose high risks for individuals and communities. the unpredictability of pandemic outbreaks (agents, time, and place) is a given in communicable diseases. the gap in the incorporation of nursing knowledge and skills related to screening, disease identification, rapid response, community involvement, inter and intraagency communication, governmental notification, and coordination need not remain challenges to adequate and timely responses. the failure to develop a coordinated system of health care workers who understand the importance of detecting and forwarding information about the identification of an illness is a major gap in our ability to contain new infections. a key issue is the time delay in the early identification of infections that pose a threat to potential epidemics/pandemics. to mitigate the delay, it is essential that the health care professional who is the initial point of contact with the infected person, likely the community health worker in many global settings, communicate with the appropriate provider or agency to initiate the next steps including identification of the pathogen, initiation of appropriate treatment, and prevention of further dissemination. in addition, recognition of a pattern, alerting others as to the emerging disease, and preventive services will aid in preventing further diffusion of pathogens from isolated cases. a delay in such identification may lead to the development of epidemics/pandemics and be an impediment to the prompt initiation of treatment for the infected individual, appropriate interventions and protective devices, and efforts to curtail the spread of the epidemic. recent events, such as the ebola outbreak, demonstrate how lack of preparation and gaps in communication systems during the alert phase when a pathogen has been identified contribute to a delayed response . national and global organizations have evaluated the adequacy of the timeliness and programmatic response to potential outbreaks, and have examined what remains to be accomplished (sands, mundaca-shaw, & dzau, ) . the world health organization department of pandemic and epidemic diseases (ped) develops strategies, initiatives, and mechanisms to address emerging and re-emerging epidemic diseases to reduce impact on affected populations and limit international spread (world health organization, n.d.). although the ped brochures note that their work is implemented through a multidisciplinary team that includes disease-specific and public health experts with field experience responding to outbreaks and emergencies under the international health regulation, it is not clear how nurse input is provided and communicated with the team. the u.s. department of health and human services office of pandemics and emerging threats engages with multiple governmental and nongovernmental partners and agencies to set policy and support initiatives to prevent, detect, and respond to health threats and provides leadership and coordination of international activities through policy analysis, program development and implementation, coordination, and strategic planning (u.s. department of health and human services, n.d.). again, it is not clear how nurse input is provided or utilized during the early stages of the health challenge. the global advisory panel on the u.s. department of health and human services ( ) organized by sigma theta tau international met with key nurse stakeholders throughout the world and released a - summary report (the global advisory panel on the future of nursing & midwifery (gapfon)) (u.s. department of health and human services, ). using accumulated rankings across all geographic regions, communicable disease was one of the top five health priorities identified by nursing leaders (www.gapfon.org). the contribution of nurses from all types and levels of practice to an improved response to global pandemics also has been noted (edmonson, mccarthy, trent-adams, mccain, & marshall, ) . the u.s. centers for disease control and prevention (cdc) identified several time intervals important to organizing an effective response to an emerging pandemic. the first is recognition interval: recognition of increased potential for ongoing transmission, described as the time when increasing numbers of human cases or clusters are identified anywhere in the world (cdc, ) . although the organizational responses noted above contribute to earlier and more rapid identification of communicable diseases, the contributions of nursing are missing. the aim of this academy policy is to fill this gap by identifying the essential role of nurses and community health workers during the time just prior to the confirmation of a potential epidemic and focuses on the early identification of infectious pathogens and prevention of further transmission. for this to occur, nursing leaders must develop a grounds-up approach to the formulation of solutions to local problems of national and international significance. the best response to a potential global pandemic is prevention. early recognition of novel infections will be enhanced by the development of linkages between community and clinic nurses and the initial point of contact with the infected individual. this will require the education and empowerment of community health workers who have regular and on-going contact with the inhabitants of villages, towns, or regions, and are likely to be the first to recognize symptomatic individuals and consequently serve as the first line of defense through the early and prompt identification of emerging or re-emerging infectious diseases. a policy that requires the development of a network incorporating the community health workers into an early warning system will facilitate the prompt identification of potentially communicable diseases. the early identification of suspicious illnesses requires that these individuals are educated regarding symptoms, modes of transmission, information about ways to interrupt the chain of infection, and who and how to make contacts for rapid follow-up. providing a cell phone or other communication device to community health workers or others likely to be an initial point of contact may be an efficient, cost-effective approach to facilitating the early identification of communicable diseases. this will also serve as community recognition of the importance of their role. collection of a specimen from the sick individual, if feasible, and restriction of contact with that individual, to the degree possible, will also minimize transmission of the infection. the use of technology will increase the efficiency of early identification of prospective epidemics. transport of a potentially infected individual, as appropriate, to a primary care clinic or district hospital may be essential to obtaining a differential and confirmatory diagnosis and for treatment. prompt identification and treatment of the infected individuals, and prevention of further transmission, requires the rapid deployment of appropriate treatment regimens and protective gear to the caregivers in the affected areas. in addition to preparing frontline community workers to promptly identify potential emerging or re-emerging infection, appropriate national nursing councils and public health entities could be charged with the responsibility of developing and sharing early reporting networks. engaging international and national agencies (e.g., world health organization, international council of nurses, american nurses association, cdc) in such networks would further facilitate rapid mobilization of responses. these recommended actions are consistent with cdc's national strategic plan for public health preparedness and response to protect people's health and secure the nation's public health, (cdc, ) directly addressing the need for "a change in approach and longterm visioning across the various u.s. agencies involved in global health…with an emphasis on integration and partnership" (national academies of sciences, engineering, and medicine, ). the american academy of nursing affirms the importance of nursing leadership for the early recognition of communicable diseases and therefore calls on nursing leaders in each country to develop a coordinated network for response to emerging or re-emerging infections that is based on a grounds-up approach incorporating frontline individuals and communities likely to be the first to recognize symptomatic individuals as first responders. this policy aligns with the academy's strategic plan - , goal , objective : "support policies and practice design that promotes nurses as clinicians and leaders in care coordination and primary care" (american academy of nursing, ). it is also consistent with the academy policy, increasing the capacity of public health nursing to strengthen the public health infrastructure and to promote and protect the health of communities and populations (kub, kulbok, miner, & merrill, ) . global pandemics are a threat to every nation's health and therefore improvement in recognizing, containing, and controlling infectious diseases must be a global health priority. the american academy of nursing asserts that nurses are prepared for the leadership roles in policy decisions of health systems and government agencies, and can prepare for, identify, respond to, and direct recovery efforts from global pandemics that require an informed, internationally coordinated response (american academy of nursing, ). the policy recommendations provided below will strengthen national health security through the enhanced recognition and expansion of the individuals who are initial points of contact in the community as well as the role of nurses and nursing organizations in responding to and preventing potential global pandemics. have developed a national grounds-up nursecoordinated network, advocate for funding from appropriate sources (e.g., the gates foundation, the world bank) for the education of community health workers and for the distribution of cell phones or other devices to personnel likely to be first points of contact with infected individuals to facilitate rapid communication with next level providers. . encourage the icn, the national league for nursing, the centers for disease control and prevention, and community health worker representatives, to develop a curriculum for community health workers regarding the identification and reporting of infectious diseases. . urge global leaders (icn, who, cdc) to develop a strategic plan for local distribution of resources (pharmaceuticals, lab equipment, and other treatmentrelated materials) in case of emerging epidemics. academy of nursing policy manager and staff liaison - strategic plan a national strategic plan for public health preparedness and response beyond the ebola battle-winning the war against future epidemics emerging global health issues: a nurse's role. ojin: the online journal of issues in nursing emerging infectious disease repository american academy of nursing policy: increasing the capacity of public health nursing to strengthen the public health infrastructure and to promote and protect the health of communities and population emerging infectious diseases: threats to human health and global stability the neglected dimension of global security-a framework for countering infectious disease crises global rise in human infectious disease outbreaks department of health and human services (n.d.) office of global affairs, office of pandemics and emerging threats (pet) the global advisory panel on the future of nursing & midwifery (gapfon®) report. retrieved from the top causes of death. media centre from panic and neglect to investing in health security: financing pandemic preparedness at a national level (english) key: cord- - lf n mr authors: mihaylova-garnizova, raynichka; plochev, kamen title: case study – bulgaria date: - - journal: biopreparedness and public health doi: . / - - - - _ sha: doc_id: cord_uid: lf n mr the aim of this paper is to map the current situation in bulgaria’s public healthcare system with regard to bioterrorism response. it explores the main public health threats and focuses specifically on the changing perception of bioterrorism as a potential threat to the country. furthermore, it explains how this perception is reflected in the existing legal framework and administrative structures. the paper makes the case for the further development of an integrated, flexible and sustainable national management system to respond effectively to emergencies and presents the major challenges for the country in this field. it makes a comparison between military and civilian agencies in their preparedness to respond to naturally occurring emergencies and threats of biological attack. this review points out the higher but still limited capacity of the military medical facilities in bulgaria. the overall evaluation underlines the need for further strengthening of the relationship between military and civil capabilities and between public healthcare and security and law enforcement structures. as a result the authors make the case for stronger cooperation between military and civil medical facilities as well as for inter-institutional and interdisciplinary dialogue on the expert and political level on biopreparedness in bulgaria. the aim of this contribution is to map the current situation in bulgaria's public healthcare system with regard to bioterrorism response. in bulgaria public health and biopreparedness are still regarded as two independent public policies. public health, including control of infectious diseases and the counter of epidemics, is a priority of the ministry of health while preparation for response to bioterrorism is almost entirely within the scope of the activities of the ministry of defence. moreover, until recently the efforts of the military experts were focused completely on the problems of biodefence in the event of an attack with biological weapons and the basic protection of the army. on one hand, the prioritization of the protection of the civilian population from bioterrorism on the global scene in general, and the emergence of new epidemics of infectious diseases, on the other hand, naturally impose the need for coherence and cooperation of efforts of different institutions in bulgaria for responding to bioterrorism. furthermore, in the beginning, a covert biological attack cannot be distinguished straightforwardly from a naturally occurring epidemic, in which case the response will be handled by the existing public health structures. the overall evaluation is that bulgaria has no experience in countering bioterrorism. the main public health threats concerning infectious diseases in bulgaria are de fi ned in the health act and its additional regulations. about diseases are indicated in the of fi cial list of infectious and parasitic diseases, which are subject to mandatory registration, noti fi cation and reporting (table . ) . however, not all of the items in the list are subject to regular monitoring. regular updates are given for % of the infectious diseases. the data for morbidity of the most important communicable diseases for the country is published in the weekly epidemiological bulletin (table . ), published by the national centre for infectious and parasitic diseases. contrary to the existing infectious diseases list, bulgarian authorities do not have an established of fi cial list of potential agents for bioterrorism. in a recent publication we have proposed a list of bio-agents (table . ) which represent a potential threat for bulgarian citizens in case of bioterrorism, taking into account the following criteria [ ] : the immunization calendar of the country; and • the implementation of commitments to peacekeeping and other missions. • this lack of of fi cial position on the threat of biological agents needs to be further clari fi ed. until very recently according to the bulgarian authorities there was no risk of terrorism in the country, including risk of bioterrorism. this attitude is changing and the new position of the government is that bulgaria faces the risks and threats common to the euro-atlantic area which include terrorism and weapons of mass destruction. the new national security strategy of the republic of bulgaria (nss), adopted by the national assembly on february , states that "risks and threats (including bioterrorism) to the security of the republic of bulgaria and its citizens largely coincide or are similar to those that threaten other eu countries and nato" [ ] . the strategy gives special attention to asymmetric threats, especially international terrorism and proliferation of weapons of mass destruction (wmd) and their impact on security in a global and regional context. the document underlines the increasing possibilities of the use of radioactive materials, toxic substances and biological agents, as well as access to information databases and technology for the combat of terrorism. particular attention is paid to a number of issues: the new approach indicates the importance of building an integrated, fl exible and sustainable national management system to respond effectively to crises. in order to reach an effective crisis management level, it is necessary to develop integrated military and civilian capabilities for action in the country and the eu. this new orientation in the strategic thinking has not been further developed into procedures and other types of documents, including of fi cially recognized bio-threat agents. the perception of risk re fl ected in the new national security strategy and the necessity of integrated military and civilian capabilities fully correspond to the existing legal framework. firstly, it should be pointed out that the current legal framework re fl ects the changes that have occurred in bulgaria in the past few years. secondly, the framework has been fully revised in light of bulgaria's membership in nato and the european union. as a result, bulgarian authorities have aimed at achieving full alignment with internationally acknowledged crisis management systems. even though an overall look at the existing framework, reveals a strong foundation for bulgaria's anti-terrorism and wmd defence policies, a deeper observation shows lack of a strategy explicitly addressing the threat and response to bioterrorism [ ] . the key acts and plans in bulgaria on these topics are listed below for information. however, their full description and evaluation is beyond the scope and focus of this paper. the following governmental bodies are engaged in emergency response and preparedness, including in the case of a bioterrorist threat ( the irs includes the general direction "civil protection" (gdcp), the general direction "general fire safety and protection of population" (gdfspp) and the regional directions of the ministry of interior, as well as the centres for emergency medicine (cem) and its regional divisions of the ministry of health. the main components of the irs are present in all districts and municipalities throughout the country. in case of a disaster, the chief of operations manages and coordinates the activities of territorial units of irs on the scene. this position is held by the chief of the territorial unit of the gdfspp. in the case of epidemics, the activities on the scene are managed by the director of the regional health inspection. in the following sections, we will have a detailed look at the key bodies involved in emergency response. minister of interior mtitc ministry of transport, information technologies and communication rcem regional centres for emergency medicine rdcp regional direction "civil protection" rdfspp regional direction "general fire safety and protection of population" rdmi regional directions of the ministry of interior general direction "civil protection" (gdcp), part of the ministry of interior, currently performs a number of tasks related to disaster relief. firstly, the body warns and signals of the threat of a disaster which also includes the case of state of war ( fig. . ) . secondly, it performs search and rescue operations during disasters, including emergency works. in case of incidents and emergencies related to harmful materials and substances, the general direction is in charge of radiation, chemical and biological protection. in terms of actions for prevention, gdcp organizes education activities and trainings of the population to react during disasters as well as the implementation of protective measures. even though gdcp has substantial functions in emergency prevention and response, it lacks tasks directly involved in the use of bioweapons or naturally developing pandemics. in addition to this drawback in its role, it also lacks medical personnel. for this reason gdcp is working in close coordination with the centres of emergency medicine (cem). state agency "state reserve and war-time stocks" is the specialized body of the council of ministers that pursues the state policy in the fi eld of the accumulation, in bulgaria, the main stocks piled into the system of state reserves, for which the state agency is responsible, are: fuels, chemicals, foods, ferrous and non-ferrous metals, spare parts, timbers and paper, medical provisions, hospital equipment, and tools. in case of a biological attack these are the available resources of the agency. it has the main equipment in terms of medical provisions except serums and vaccines which are kept at the national centre of infectious and parasitic diseases. the state agency for national security (sans) was created in and it is still in the process of development. the state agency for national security is a specialized body for counter-intelligence and security and its chief responsibility is to detect, prevent and neutralize the threats to the bulgarian national security [ ] . in order to ful fi l its duties, sans uses in its work the whole spectrum of counterintelligence means and resources. the agency operates against the classic intelligence and non-traditional threats and risks, provides government authorities with information needed for the decision making in the national security sphere. one of its tasks is the gathering of information regarding time, location and media of dissemination of the biological agent. moreover, with respect to prevention of terrorism, including bioterrorism, the agency performs tasks of surveillance, detection, counteraction and prevention of: the main concern under discussion about sans's functions and activities is the order, volume and use of the acquired and analyzed information for the planning to counter a biological attack made by other authorities. this problem stems from the lack of publicity of the reports evaluating the risk of bioterrorism. therefore, due to the classi fi ed nature of the information, further estimates about the activities performed by sans with respect to biological threats cannot be made. the ministry of health's main functions encompass two of its strategic goals with respect to emergency response (fig. . ) . first of all, it is responsible for surveillance, prevention and protection from infectious diseases. second, it deals with the organization of the medical response in the case of a biological attack. the structures directly involved in performing these two functions are the national centre for infectious and parasitic diseases (ncipd), regional health inspections (rhis), the centre for emergency medicine and the medical facilities throughout the country (regional clinics or departments for infectious diseases). the ministry of health has issued a plan for public protection in the case of disasters including terrorism, as well as counteraction to an in fl uenza pandemic, but the structures of the ministry do not have a speci fi c plan for actions in case of biological attack. as a result of its efforts in the research and surveillance on infectious diseases, in the european centre for disease control (ecdc) in stockholm declared fig. . ministry of health and its structures ncipd as a leading "national competent body" in the fi eld of infectious and parasitic diseases. the ncipd has the status of scienti fi c organization of the ministry of health, which aims to develop a scienti fi c basis for the fi ght against infectious diseases and methods for its implementation. therefore, the areas of intensive research are: infectious diseases, immune reactivity, epidemiology, laboratory diagnostics, and treatment and prophylaxis of bacterial, viral, and parasitic infections. ncipd includes all national reference laboratories (nrl) in various bacterial, viral and parasitic infections. the ncipd, acting in cooperation with the european centre for disease prevention and control, has developed the capacity for surveillance of the spread of infectious diseases and the modern diagnostic capabilities for biohazard level iii infections. the reaction to the bird fl u pandemic has demonstrated this capacity. the centre is capable of observing the dissemination of one biological agent, but is not designated to coordinate activities to stop it. the ncipd holds the country's reserves of serums and vaccines to be used in cases of biological attack and epidemics. ncipd has developed a plan for a bioresponse; however, access to the documentation is restricted. the regional health inspections (rhis) replaced and merged the functions of the regional inspectorate for protection and control of public health and the regional health centres. the new body started working in january and it is still in the process of its development. the rhis include the regional authorities, performing practical activities concer ning public health, such as the identi fi cation of the source of communicable diseases, epidemiological studies and health education activities. similar to the case with its two predecessors, the ministry of health has not delegated tasks to the inspections related to planning its activities in case of a bioterrorist attack. in addition to the ncipd and the regional health inspections, the ministry of health manages civilian medical facilities which include hospitals, clinics or departments dealing with infectious diseases on the regional, municipal, and district levels. the civilian medical facilities have the necessary experience to respond to the most common epidemics, but lack the capacity -administrative, personnel and material -to act during a bio-attack. the state structures having both the capacity and preparedness to act in case of bioterrorism are the ministry of defence and the military medical academy (mma), responsible for the medical treatment of the army [ ] . that is why mma is the only organization able to ensure protection both for the military forces and the civilian population during a bio-attack. the goal was to build hospital facilities for the reception, isolation and treatment of patients with infectious diseases, and especially for dangerous infections, naturally occurring outbreaks and response to a potential biological attack [ ] . the reconstructed clinic fi ts the modern construction and technology requirements to prevent disease transmission and reduce morbidity of the victims of naturally occurring epidemics and those from biological attack. the clinic is located in a separate building, which allows protection to prevent the spread of infections in other medical departments of the hospital in so fi a. cid has: capability for isolation and treatment of especially dangerous infections of the • bio-safety level and ; access through a main road and by helicopter; • trained medical personnel for bio-attack situations. • contrary to the clinic of infectious diseases in so fi a, other military hospitals in the country do not have the same capacity for response to bio-threats. since other hospitals lack plans, resources and trained personnel, in the case of bio-attack they will be assisted by cid, the military medical unit for emergency response, and mobile military hospitals. the latter are intended to be used in these regional military hospitals, which do not have infectious wards. as a general scenario, the military hospitals without infectious wards sign agreements with the civilian hospitals in the same city or region for the transfer of patients. the issue with these agreements is that regardless of the availability of beds they lack the resources for an adequate response to a bio-attack. for this reason the agreements foresee that civilian hospitals will receive support from the medical personnel of mma. both military and civilian hospitals suffer serious shortages of infectious disease professionals which number about medical doctors for the entire country. this is the result of the policies of the ministry of health and the national health insurance fund (nhif) which fail to assure the necessary budget line for infectious diseases. an issue which has not been subject to public and expert discussions is the interaction between public (civilian and military) and private facilities in case of a bio-attack. this is the case due to the rising number of privately owned hospitals which operate within the network of public healthcare fi nanced by the national health insurance fund even though they do not have any responsibility in naturally occurring epidemics and bio-attacks. to sum up, fi rstly the subject of bioterrorism and preparedness in bulgaria is fairly new. however, the institutions involved have started developing a strategic approach for this possibility. these efforts are limited by the continuous changes in the legal framework and the implementing structure. the changes are re fl ected to a lower extent in the organizations responsible for naturally occurring epidemics. secondly, in this changing environment the military medical structures hold the highest capacity in emergency response to bio-threats. here as well, the capacity remains below the necessary level. regardless of this fact, since the resources in the country for the prevention of bioterrorism are very limited and the health care system is undergoing serious reform, the military medical capacity could be used to protect civilians. thirdly, as a result of the limited capability and resources, the need for cooperation is increasing. in some cases this is already the case, while in others the gap has to be addressed even further. the most important of these are the relationship between the public healthcare and preparedness for bioterrorism and the relationship between the public healthcare and security and law enforcement structures. the inter-institutional and interdisciplinary discourse in bulgaria on the expert and political level is yet to come. offi cial gazette organization of the activities of the medical facilities of the military medical academy in response to a biological attack medical activities organization within bulgarian army to counter in case of biological weapon usage key: cord- -s iavz u authors: ali, harris; dumbuya, barlu; hynie, michaela; idahosa, pablo; keil, roger; perkins, patricia title: the social and political dimensions of the ebola response: global inequality, climate change, and infectious disease date: - - journal: climate change and health doi: . / - - - - _ sha: doc_id: cord_uid: s iavz u the ebola crisis has highlighted public-health vulnerabilities in liberia, sierra leone, and guinea—countries ravaged by extreme poverty, deforestation and mining-related disruption of livelihoods and ecosystems, and bloody civil wars in the cases of liberia and sierra leone. ebola’s emergence and impact are grounded in the legacy of colonialism and its creation of enduring inequalities within african nations and globally, via neoliberalism and the washington consensus. recent experiences with new and emerging diseases such as sars and various strains of hn influenzas have demonstrated the effectiveness of a coordinated local and global public health and education-oriented response to contain epidemics. to what extent is international assistance to fight ebola strengthening local public health and medical capacity in a sustainable way, so that other emerging disease threats, which are accelerating with climate change, may be met successfully? this chapter considers the wide-ranging socio-political, medical, legal and environmental factors that have contributed to the rapid spread of ebola, with particular emphasis on the politics of the global and public health response and the role of gender, social inequality, colonialism and racism as they relate to the mobilization and establishment of the public health infrastructure required to combat ebola and other emerging diseases in times of climate change. poor nutrition, eroding infrastructure, and ebola transmission rates. section "stigmatization and the local and global response to ebola", discusses the role of stigmatization in the political and global aid response to ebola. section "community engagement and the ebola response", examines the long-term impact of global health assistance on sustainable community-based health services. the conclusion builds on this background to consider ebola's lessons in relation to future and emergent health risks in times of climate change. ebola's emergence is grounded in the legacy of colonialism and its contribution to enduring inequalities within african nations and globally. the contemporary expression of this history is seen in the "washington consensus," the international aid industry and the underfunding and decentralization of service delivery, through privatization, reduced public expenditures, and lack of access to health care for the most vulnerable. developmentalism still informs and has implications for the effectiveness of current public health responses. the racist discourse of the diseased, incapable african, requiring outsiders to swoop in to save the day, can only be superseded through sincere and authentic participatory approaches-real collaboration between global institutions such as the world health organization (who) and local public health and government officials. the whole world bears the responsibility for the ebola crisis. as noted by the people's health movement, "the epidemic, in all probability, will run its course and die down after leaving a trail of death and destruction (not) because we as a global community would have done very much right, but because of the nature of the virus itself. the moot question is, will we have learnt anything? or will it be back to business as usual?" (phm : ) . market demand from consumers in the global north fuels the resource exploitation that produces the conditions in which the ebola epidemic emerged, and other diseases are sure to follow. ebola has its origin in "the unchecked exploitation of natural resources by international timber and mining companies," as the observer ( ) noted in early october based on a who report on the disease. as long as ebola erupted sporadically in small villages along the global resource economies' path, as it did beginning in the s, the outbreaks flared up and went away as quickly as the global corporations leave their tailings ponds behind. the situation is different now. the virus found its way along the human food chain towards the exploding centres of a rapidly urbanizing africa. it reached large cities with their huge inequities, overcrowding, and underdeveloped sanitation and public health systems, and only extreme measures fuelled by moral panic have thus far (and perhaps temporarily) prevented its global spread in the same way sars expanded across the globe in . the unspoken divisions in how these measures play out reveal deep injustices at the global level. for example, in the early days of the ebola crisis, some criticized the unavailability of vaccines to help the sick, despite the fact that several vaccines had been in development for many years in the global north (stanford ) . it was also pointed out that a large pool of exposed but disease-resistant people, such as those now living in ebola-ravaged areas of west africa, would facilitate the development of a serum-based vaccine. even if a vaccine is developed and tested, will it ever be widely available and accessible to all those who need it, in africa and globally? will this become yet another source of profits for big pharma? as has often been noted, there are "tensions inherent in the socioeconomic construct that is today's pharmaceutical industry [which on one hand seeks to protect] the health of the public, but on the other it seeks to maximize profit" (cohen et al. : ) . there may, then, be an understandable concern that seeking a cure or antidote for ebola might become either an opportunity for the pharmaceutical industry to use africa as a laboratory (see chippaux ) , or as another source of profits for the pharmaceutical industry, rather than promoting the enhancement of well-being. or, as david healy has said more dramatically, "an incentive to chase blockbuster profits-doing so regardless of patient welfare" (healy : ) . the who, hit hard by un retrenchment related to the global financial downturn, cut its budget and downscaled its activities rather than insisting on adequate support and new funding approaches, which left the who woefully unprepared to help guinea, liberia and sierra leone mount a speedy and effective ebola response in early (phm ; lee ; harman ; kay and williams ). this put organizations like medecins san frontières (msf), missionaries, and cuban doctors in the position of heroic first responders in very difficult circumstances. points out ibrahim abdullah, who teaches at the university of sierra leone (the oldest university in west africa) in freetown, the epicenter of the epidemic, "this is the neo-liberal scourge: if you privatize health care in the context of mass poverty, you get the ebola epidemic. if, however, you put people at the centre of development by modernizing health and education, you can prevent ebola. ebola is about governance and modernity" (personal communication ). this crisis is neoliberal precisely because each of the three hardest-hit countries (liberia, sierra leone and guinea), in addition to suffering civil wars and large-scale human displacement over the past decade, were also encouraged to privatize health care and introduce-fee-for-service systems that crumbled amidst poverty-a recipe for the ebola disaster (phm ) . this impoverishment has also opened up the same countries for land-grabs, mining exploitation, rapacious foreign direct investment, agro-forestry, habitat destruction, and human displacement which destroys social resilience, endangers public health, and makes quarantine and disease-control systems nearly impossible to manage. the only way to combat these trends is for african states to be encouraged and supported in the harder part of development: building health care and education systems that are public and sustainable. the ebola crisis reveals, thus, both shorter term and longer term issues of development, which represent the deeper crisis affecting not only the three main ebola-affected countries but global distribution in general. the west africa of the ebola epidemic is one of the fastest urbanizing regions on the planet (diallo and dilorenzo ; salaam-blyther ). perhaps the most dynamic social process in africa is its rapid urbanization (including peri-and suburbanization). the ravaging of the countryside by resource companies and the expansion of the urban fabric into regional hinterlands demonstrate the interface between humans and infectious disease. this is, of course, not just an african story. a planetary process of urbanization is underway across vast networks of infrastructure lines, resource supply chains and human travel (brenner ) . as much of this urbanization leads to massive peripheral settlement in existing and new urban centres, often in contiguity with previously mostly undisturbed natural landscapes, we can speak of "suburban constellations" at the heart of the process (keil ; bloch ; mabin ; leahy ) . a new landscape of risk emerges (bloch et al. ) . in mining towns, sometimes physically remote and isolated but connected through global metabolisms and labour markets, we can speak of a "feral" form of suburbanization that confronts human and non-human nature in direct encounter (shields ) . by , it is expected that urbanized land on the planet will cover . million square kilometres which is twice as much as in . this massive urbanization is unequally distributed across the globe, with china and africa absorbing the lion's share of global urbanization during the next generation. we can expect significant consequences for climate change, biodiversity, etc. (seto et al. ; oxfam ) . in this context, ebola, once thought of as being an isolated problem in remote rural areas, has become an urban disease affecting cities and their peripheries, where its spread tends to be rapid and seemingly random due to massive human interaction and often dense and unhygienic living conditions. in the past, disease outbreaks were associated with squalid and unhygienic urban conditions and the immobility of affected communities (keil ) . the new bundled problematique of urbanization, density, and migration has often been the source of huge moral panic (wald : - ) . emerging forms of urbanization lack the infrastructure necessary to support communities in a health emergency. places like kroo bay in freetown, described by a journalist as "a labyrinth of shacks and muddy pathways perched at the edge of a large rubbish dump stretching out into the atlantic ocean", caused concern amongst health care professionals. one was quoted as saying that "these places are always prone to outbreaks" (trenchard : n.p.) . but now the attention is on the (transnational) network of extended urbanization as "the virus is travelling effortlessly across borders by plane, car and foot, shifting from forests to cities and springing up in clusters far from any previously known infections. border closures, flight bans and mass quarantines have been ineffective" (diallo and dilorenzo : n.p.; see also salaam-blyther ; keil ) . standard textbooks on globalization and health tend to overlook the urban dimension and lean towards seeing urban political pathologies in the framework of the nation state system (cockerham and cockerham ; price-smith ). with the sars crisis of , the world was made aware of the importance of cities in the governance of global health crises (ali and keil ) . but this also meant moving from public health governance in and by cities to global public health governance in urban society-a different challenge altogether. the ebola crisis points further in this direction: public health institutions and procedures in cities are absolutely critical (and they often failed in the cases of sars as well as ebola). the time has come for a systemic and networked view of governance (and not just health governance) across the global urban expanse, the entire field of extended urbanization. global institutions, in their imperfection, have begun to act. urban public health systems could be a prime target of international aid to stave off the ebola threat while creating the conditions for future epidemic prevention. the who made a courageous step in to strengthen the roles of cities in improving public health and in the fight against emerging infectious diseases (who ). while ebola proved to be resistant to many conventional containment measures, the strengthening of urban public health institutions in the overall architecture of global health governance and responses is certainly a path that must be pursued in future outbreaks of this and other infectious diseases as cities grow faster and in different patterns than in the past. the impoverished public health sector and desperate state of critical infrastructure in guinea, liberia, mali and sierra leone-barely functioning hospitals, inaccessible and inadequate care with few medical staff, intermittent electricity, underdeveloped transportation networks and non-existent communication networks-are markers of the extent to which the ebola outbreak was able to spread and impact the region (who ; oladele et al. ) . lack of surveillance, monitoring, andlaboratory facilities delayed early ebola diagnoses until march . the region's history, beset by political and social unrest and internal strife, adds to the complexity. both liberia and sierra leone experienced over a decade long civil conflict that decimated their already weak public health infrastructure. health care expenditures in these countries are heavily dependent on foreign aid, tied to commitments that often prohibit investments in public infrastructure (undp ) (table . ). furthermore, countries with a health care workforce below who's recommended critical threshold of professionals (physicians, nurses and midwives) per , people have a lower resilience for diseases and epidemics (afri-dev.info ; who a) (table . ). it is no surprise that the ebola response was weak and characterized by what msf ( ) cites as huge gaps "in medical care, training of health staff, infection control, contact tracing, epidemiological surveillance, alert and referral systems, community mobilization and education"-important components of a comprehensive ebola preparedness and response plan as outlined by the who. mistrust, miscommunication, and rumours fuelled community resistance and avoidance that interfered with public health measures in the region (fofana ) . unlike nigeria and mali, sierra leone, liberia and guinea's outbreak started in rural areas with porous geopolitical borders, plus woefully inadequate and inaccessible public health care, forcing people to seek alternative affordable and accessible traditional medicine (who ). nigeria and mali had successful outcomes for several reasons. first, as the epidemic was in its fourth month, they had enough time to draw up ebola preparedness and response plans. second, both countries repurposed existing infrastructure for ebola: nigeria used its polio facility as an ebola response centre and mali equipped an existing laboratory for ebola testing (who b (who , c (who , . third, the index case arrived in urban cities, where medical care was available (nigeria's by air to lagos city and mali's via road to bamako), allowing for quick diagnosis and activation of monitoring and contact tracing. the region's colonial history depicts an exploitative and extractive relationship with the global north since the s, plus a history of disease importation to the region, and is the backdrop that sheds light on the level of mistrust of national and international agencies that partly shaped public response to the ebola outbreak. for example, in august , the spanish influenza arrived on the shores of sierra leone aboard a british naval vessel (rashid ; olaniyan ) . rural areasthe disease epicenter-are underserved. post independence, national governments perpetuate this exploitative legacy. in sierra leone, rural agriculture and minerals account for a high percentage of national gdp, yet rural areas have not had proportional investment in basic infrastructure like health, water and sanitation and transportation networks (bti ) . it is increasingly evident that climate change is adversely affecting human health. the health burden of climate change also includes the emergence and source: afri-dev.info ( ), dumont and zurn ( ) increased incidence of infectious and water borne diseases. the current ebola outbreak was a chance encounter between a -year old child and a fruit bat, the reservoir for the virus (baize et al. ; saéz et al. ; who ) . some studies cite climate variability as the cause for fruit bats to migrate long distances and reside near cities and towns (frumkin et al. ; pinzon et al. ). an action aid ( ) study on the increasing flood frequency in six african cities reports that "climate change is altering rainfall patterns and tending to increase storm frequency and intensity". in sierra leone, recent extreme weather observed includes heavy rains that cause flash floods, mass land movement, injuries and fatalities, and infrastructure damage ( women accounted for roughly - % of deaths in the ebola epidemic (wolfe ). ebola's gendered impacts-including greater fatality rates for pregnant women, higher risks for caregivers who are often women, and dangers from sexual violence due to ebola-related economic collapse (thomas )-have implications for social resilience, survival of caregivers and mothers, economic in sierra leone, june to august is called "the hungry season," when heavy rains make it hard to harvest and obtain food decline and subsequent recovery in disease-affected areas, and the strength of public health systems (perkins ) . when economic and ecological pressures, exacerbated by climate change, bring people and animals into closer contact while uprooting communities, depleting health care systems, undermining social resilience, and degrading infrastructure, this becomes a "perfect storm" for the emergence and spread of infectious disease. disease ecology reminds us that the transmission dynamics of infectious disease spread involves a complex interplay between natural ecosystems, human economic activity and cultural belief systems (mayer ). an oft-neglected consideration of the disease ecology is the role that stigmatization may play in disease transmission dynamics. stigma is a common aspect of all cultural systems and quite often used in the service of social control (goffman ) . as such, despite the reality of the lethality of ebola, the challenges that stigmatization poses for the effectiveness of outbreak response should not be trivialized. patients may conceal the fact that they are infected, for various reasons related to stigmatization. for instance, one liberian physician observed that "some patients don't tell the truth. they come to you with a different story, like 'abdominal pain'. it's because of the stigma of ebola. they think they won't be treated and they'll be sent away" (york c ). stigmatization in the ebola outbreak situation is not limited to patients. health care workers, for example, were evicted from their homes by landlords out of fear (york b) . furthermore, mobs in rural villages attacked journalists and health care workers (including those engaged in educational efforts but especially those responsible for removing the deceased). similar to the situation with hiv/aids (lewis ) , orphans whose parents had succumbed to ebola also became stigmatized during the earlier stages of the outbreaks. given that unicef found that as of february , there existed , orphans in the ebola-affected west african countries (un newscentre ), the potential for a tragic problem has loomed. however, a unicef official remarked on a positive note that: there were fears that stigma around ebola would isolate the orphaned children, which would mean there would be thousands of abandoned children, but that has, luckily, not materialized. (un newscentre : n.p.). unicef programs provided cash support, material assistance, psycho-social support, and implemented programs to refer families for food assistance. this collectively helped to mitigate the effects of stigmatization and led to % of the orphaned children being reunified with their extended families (ibid.). combatting stigma in populations where half the population is illiterate poses challenging problems. programs that have successfully addressed such challenges may however be found. in monrovia, billboards and posters visible on every major street helped to raise awareness, while thousands of "social mobilizers", consisting of health workers, teachers, religious leaders and youth activists, were recruited in ebola-affected areas to spread the message about the disease (york b) . unicef produced videos and catchy songs with the same intent (ibid.). public health responders from outside west africa were themselves hampered by stigmatization. this is an especially important issue in light of the observation by the who director-general that the ebola outbreak response urgently required outside assistance (weintraub ) . western hospitals were reluctant to allow medical staff to go to west africa, or take in ebola-infected patients, due to worries of being labelled as the "ebola hospital" in their community, or because of concerns that taking such actions would cause anxiety amongst in-house hospital staff (york a) . at another level, stigmatization may be understood as coming from the conflation of race with disease. this association may be bolstered by the term "ebola" itself. according to one linguist, "ebola" connotes to american listeners the very idea of africa because of its sound similarities to 'ebonics' or 'ebony' in the american vernacular (troutman ) . these types of stigmatization have deep structural origins that can be traced to the legacies of imperialism and colonialism in which "tropicality" is associated with disease (bankoff ) . in this type of colonialist discourse, "other" parts of the world are depicted as dangerous, particularly those with "warm climates" from where "new and emerging diseases" are seen to emanate in the twenty-first century (ibid). the effects of such neocolonial influences are seen, for example, in the way in which medical research in the global north has benefited from blood, parasites, and viruses collected from the people of the global south. the patented vaccines developed from such materials benefit those in the global north (and especially the private pharmaceutical companies). as noted by fearnley ( ) , such biomedical gains did little to help build public health capacity and infrastructure within west africa. dealing with such enduring forms of stigmatization is vexing because of the structural dimensions involved in the geopolitics of dependency and global north-south relations. one way forward, however, may be seen in the recent efforts of the african union to establish an ebola solidarity fund and an african centre for disease control by mid- (anders ) . this initiative may have the potential to serve as an impetus to organize and institutionalize efforts against the types of stigmatization that ensue from structural dependency and power differentials embedded in neocolonialism. while ebola may be lethal for those contracting the disease, many, especially the medical practitioners involved in fighting ebola (see gbakima et al. ) , as well as a number of mainstream journalists, have pointed to the media sensationalism surrounding the disease. as such it has been noted that there is a "tendency (in) the international media to attract viewers (which) has led some careless journalists to focus almost exclusively on the fear-invoking mode of death from the disease" such as the garish images of victims "coughing up blood" (wallace ) . such foci are often fed by stereotypes about africa, which are also linked to the oft-depicted image of africa as a site of primitivism and catastrophe, the sources of which lie in colonial discourses of backwardness, exoticism and savagery. thus, while it may be that having a fear of ebola is a somewhat understandable response and not in itself a colonial attitude, the colonial legacy nevertheless exerts a tacit and often unrecognized influence on the fear. specifically, it may "fan the flames of fear" or to put it in more technical terms, the colonial legacy may contribute to the phenomenon known as the "social amplification of risk", whereby peoples' perceptions of risk are unreasonably intensified (kasperson et al. ). one criticism of the international ebola response has been the failure of some international agencies to partner effectively with local government agencies, ngos, and community organizations to respond appropriately and effectively to the epidemic, and to build capacity for the future (gundan ; kaba jones and norman ). the need to engage communities in successful health initiatives is well-established (israel et al. ) and yet this seems to have been lost in the urgency of the international response. international initiatives responding to the ebola epidemic focused on immediate treatment responses, the development and delivery of vaccines, security and containment, and large initiatives like building hospitals. for example, canada's contribution to the ebola campaign was the provision of protective gear, setting up mobile labs, and the delivery of an experimental vaccine (public health agency of canada ). at best, these responses have been slow, expensive, difficult to coordinate, and unsustainable (gundan ). at their worst, the responses met resistance by local populations, and were slow to adapt to the local contexts, thus rendering such responses ineffective and inefficient, and in the end, leaving the communities vulnerable to the next health crises. the importance of acknowledging and respecting concerns and practices of local communities and their socio-political context has been identified as a major issue in implementing health policies and practices (nichter ) . in reviewing the trajectory of the response to the ebola outbreak, petherick ( ) noted the general lack of trust between medical teams and local communities. this lack of trust contributed to community responses ranging from hiding ebola cases from health workers, to attacking health workers and health facilities, driven by the belief that medical staff were spreading the infection, rather than trying to contain it. mitman ( ) argues that the colonial history between africa and europe is one underlying source of this mistrust, a history that began with slave traders and missionaries and continues with the current european exploitation of resources and labour and western military involvement in a range of conflicts. in the early to mid s, american medical researchers followed this path of exploitation, extracting blood, tissue and, ultimately, knowledge, on expeditions to africa, with some amount of coercion and without benefit or explanation to local populations (karamouzian and hategekimana ) . this history of violence, invasion and exploitation has not been forgotten and could only have been reinforced by the presence of western military personnel supporting biohazard-suited health workers (bayntun et al. ) . community based health initiatives are rapid and culturally appropriate responses from agencies trusted by the communities, and as such are more likely to be successful (teutsch and fielding ) . effective and innovative grassroots community led responses began immediately in ebola-affected areas across west africa and have been successful (kaba jones and norman ) . moreover, strengthening these local community organizations can also be part of a strategy to build primary health care in general (anders ) . however, obtaining international support for grassroots initiatives is challenging. most international funding is directed to eu or us organizations, which may have local initiatives and a history of working successfully in the area, but little funding is generally directed to local grassroots organizations or to the development of sustainable health infrastructure (gundan ). the ebola epidemic rose rapidly in countries experiencing severe poverty, with a recent history of political unrest and conflict, and with very poor health care systems and infrastructure. prevention of future epidemics requires development of strong social, political and health infrastructure (kaba jones and norman ). the challenge is that international responses often do little to produce sustainable development. in an interview with journalist flavie halais, development expert ian smillie noted that canada's interventions in sierra leone would have no lasting impact on the health care system (halais ) , and thus make no contribution towards the prevention of future epidemics. representatives of the uk department for international development (dfid) now claim that they should have focused on prevention and social mobilization earlier, and funneled more funding to local grassroots organizations to do so effectively (j oźwiak ). in the same article, however, the author noted that dfid's funding policies made it difficult to fund local agencies, and that they report no plans to shift funding policies, reflecting the disconnect between evidence based practices in population health, and the politics of international aid funding. ebola is a well-studied disease, not an unknown one like sars was when it first appeared in , with a fatality rate of %. ebola's genomes have been sequenced and patented, and supportive health care can reduce its fatality rate to about %, according to health researcher laurie garrett (cbc ) . but as former who staffer akong charles ndika notes, the desperate state of most african health-care systems enables the threat posed by ebola outbreaks to be maintained, and these inequities "will continue in [the] future to manufacture new and re-emerging epidemics like ebola . . . with frightening impact on a global scale" (ndika : n.p.) . moral panic is not helpful. health-care workers need the training and equipment to protect themselves, and basic health education for the general public is crucial to counter stigma, fear, ignorance, and superstition. participatory education and logistics are the main challenges, not just to build hospitals and public health interventions, but also to support food security, infrastructure and governance systems, especially at local levels across the global south. this is a huge and pressing endeavour which only the who can coordinate, working closely with local institutions. so the who must be supported-not just in words but with significant financial and material resources-in order to meet the immediate challenges of new disease outbreaks and also to build the longer-term capacity of local public health agencies so that local units can function effectively and sustainably, since future outbreaks are inevitable in today's globalized world. this applies not only to the need to increase the supply of material resources needed for the emergency response, but also the training of local staff so that they can thwart the threat themselves. broad public participation in governance of the entire health care system is also necessary, both locally and globally, so that education and democracy go hand in hand with the development of strong health care systems. urban public health systems should become a prime focus of who and international support. analysis of the social and economic roots of the ebola epidemic demonstrates that the crisis was grounded in global income inequality and the same impoverishment that had opened up countries for land grabbing, rapacious foreign direct investment and agro-forestry, the displacement of more and more people, the destruction of natural habitats and the erosion of the capacity for social resilience. these conditions will continue to produce outbreaks of emergent diseases in times of climate change, and unless they are addressed, these outbreaks will continue to facilitate ongoing global health threats. political and physical environments. this includes work on culture, migration and health inequities; climate change adaptation; and social integration of refugees. pablo idahosa (ph.d. political economy, university of toronto) is a professor in the department of social science at york university, where he directs the african studies program, and teaches development studies. he has written on development ethics, the politics of ethnicity, and national development. he is author of the populist dimension of african political thought, co-editor of the somali diaspora, and co-editor of development's displacements. among his ongoing research interests are the relationships between development and cultural production in africa, and the politics of disease in africa. he has served on the executive of the international development ethics association. he is completing a book on social welfare in africa. roger keil (dr. phil political science, goethe university, frankfurt) is york research chair in global sub/urban studies in the faculty of environmental studies at york university in toronto. a former director of york university's city institute, he researches global suburbanization, urban political ecology, cities and infectious disease, and regional governance and is principal investigator of a major collaborative research initiative on "global suburbanisms: governance, land and infrastructure in the st century" ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . he is the editor of suburban constellations (jovis ) and co-editor (with pierre hamel) of suburban governance: a global view (utp ) . patricia e. perkins (ph.d. economics, university of toronto) is a professor in the faculty of environmental studies, york university, toronto, where she teaches and advises students in the areas of ecological economics, community economic development, and critical interdisciplinary research design. her research focuses on feminist ecological economics, climate justice, and participatory governance. she has directed international research projects on community-based environmental and watershed education in brazil and canada and on climate justice and equity in watershed management with partners in mozambique, south africa and kenya, and is the editor of water and climate change in africa: challenges and community initiatives in durban, maputo and nairobi. unjust waters: climate change, flooding and the protection of poor urban communities: experiences from six african cities african factsheet on ebola challenges, health workforce and human resources for health shortages emerging diseases in the global city. blackwell, oxford anders m ( ) ebola responders tap past survivors. youth in community-based strategy emergence of zaire ebola virus disease in guinea rendering the world unsafe: 'vulnerability' as western discourse ebola crisis: beliefs and behaviours warrant urgent attention suburban governance: a global view suburbs at risk. in: keil r (ed) suburban constellations: governance, land and infrastructure in the st century sierra leone country report. bertelsmann stiftung's transformation index (bti) csi ebola: tracking the outbreak's origins. quirks and quarks ebola making a comeback in places it was contained. the toronto star immigrant health workers in oecd countries in the broader context of highly skilled migration. international migration outlook the disease that emerged. limn issue number , ebola's ecologies sierra leone ebola patient, recovered from family, dies in ambulance. reuters climate change: the public health response the truth about ebola: the real way to control ebola is to stop the fear and misunderstanding englewood cliffs gundan f ( ) liberia: how africa and africans are responding to the ebola crisis money (not) well spent? concerns raised over canada's response to ebola. devex global health governance: crisis, institutions and political economy review of community-based research: assessing partnership approaches to improve public health dfid has learned 'a lot' in ebola response. devex fighting ebola from the grassroots ebola treatment and prevention are not the only battles: understanding ebola-related fear and stigma the social amplification of risk: a conceptual framework introduction: the international political economy of global health governance transnational urban political ecology: health, environment and infrastructure in the unbounded city suburban constellations: governance, land and infrastructure in the st century the handbook of mobilities. routledge climate change and transdisciplinary science: problematizing the integration imperative corrupt global food system, farmland is the new gold. inter press service the world health organization (who) race against time: searching for hope in aids-ravaged africa suburbanisms in africa? in: keil r (ed) suburban constellations: governance, land and infrastructure in the st century geography, ecology and emerging infectious diseases ebola in a stew of fear triangulation and integration: processes, claims and implications ebola crisis update-sept th ebola: recovery of americans sharpens divisions in global health global health: why cultural perceptions, social representations and biopolitics matter an assessment of the emergency response among health workers involved in the cholera outbreak in northern nigeria africa: varied colonial legacies another inconvenient truth: how biofuel policies are deepening poverty and accelerating climate change climate justice and gender justice: building women's political agency in times of climate change. paper presented at the international association for feminist economics (iaffe) conference, accra ebola in west africa: learning the lessons ebola epidemic exposes the pathology of the global economic and political system trigger events: enviroclimatic coupling of ebola hemorrhagic fever outbreaks contagion and chaos: disease, ecology and national security in the era of globalization. mit, cambridge public health agency of canada ( ) speaking notes for the honorable rona ambrose, minister of health: the government's response to the ebola outbreak epidemics and resistance in colonial sierra leone during the first world war taking complexity seriously: policy analysis, triangulation and sustainable development the ebola outbreak: international and u.s. responses. congressional research service global forecasts of urban expansion to and direct impacts on biodiversity and carbon pools feral suburbs: cultural topologies of social reproduction, fort mcmurray, canada ebola vaccine story shows folly of free-market drugs rediscovering the core of public health ebola's gender bias sierra leone capital now in grip of ebola. aljazeera race and disease: should we change the name of ebola? aid sustainability and equity: a better future for all west african communities receiving ebola's orphans with open arms contagious: cultures, carriers, and the outbreak narrative ebola's exaggerated fear being fed by stigma and stereotypes as ebola's spread continues, warnings of an inadequate global response cities and public health crisis cholera in sierra leone: the case study of an outbreak: world health organization atlas of african health statistics : health situation analysis of african region ebola virus disease outbreak response plan in west africa nigeria is now free of ebola virus transmission. world health organization updates one year into the ebola epidemic: a deadly, tenacious and unforgiving virus. world health organization updates why are so many women dying from ebola? foreign policy only a few aid agencies willing to help fight ebola in africa. the globe and mail fear and education play crucial role in ebola crisis. the globe and mail u.s. troops arrive in west africa to help fight ebola outbreak. the globe and mail his research focuses on the analyses of 'disaster incubation': how normally unnoticed social and ecological processes converge to create a disaster, including disease outbreaks. he is currently studying the social and political implications of oil sands extraction, with a special focus on the state surveillance and monitoring of environmental activists in canada barlu dumbuya is a graduate student in the disaster and emergency management program with a concentration in environmental issues, technology and disaster management at york university. she is interested in social vulnerability, community resilience and capacity building in developing countries she conducts collaborative research with students, communities and organizations, both locally and internationally, on the relationship between different kinds of social connections (interpersonal relationships, social networks) and resilience in situations of social conflict and displacement key: cord- -in r ww authors: nan title: the way forward: prevention, treatment and human rights date: journal: global lessons from the aids pandemic doi: . / - - - - _ sha: doc_id: cord_uid: in r ww there now is a considerable body of evidence to support the view that an effective hiv/aids strategy integrates prevention, treatment and human rights. in this chapter, we emphasize the importance of each of these aspects and draw upon the conclusions reached in previous chapters to map out the future of hiv/aids. while medicine and science have a crucial role to play in addressing pandemics, whether slow-moving (like hiv/aids) or fast-moving (like influenza), the social, legal, political, financial and economic ramifications of pandemics can not be ignored. well-considered social, legal, political and financial strategies are essential in order to address any pandemic effectively. united kingdom kingdom - source: global hiv prevention working group ( ) in chap. , we discussed how integrated prevention-treatment-human rights strategies aimed at high-risk groups have proved effective in countries like brazil. in chap. , we explained that limited resources need to focus on high-risk groups and locations to achieve the best possible results. however, as we showed in the sex workers, who are the source of almost % of hiv infections, a negligible amount of funding for hiv/aids is targeted at this group. the mismatch between the most affected group and the allocation of funding in ghana highlights the importance of matching funding to prevailing prevalence and transmission patterns in a given country or region. as we saw in chap. , an hiv prevalence rate above % is a key threshold for an hiv epidemic to run out of control unless funding for prevention efforts is targeted at high-risk groups, such as commercial sex workers, men who have sex with men, injection drug users and prisoners. however, in chap. we saw that pepfar -the largest bilateral donor of funding for hiv/aids programs in developing countries -prohibits the use of funding for programs for commercial sex workers and needle exchange programs. in chap. , we saw that african-americans make up % of hiv/aids patients, even though african-americans account for less than % of the us population. moreover, black men who have sex with men (msm) have the highest rates of unrecognized hiv infection, hiv prevalence and incidence rates and aids mortality rates among msm in the united states. in five us cities, % of african-american msm are infected with hiv. hiv and aids prevalence rates have affected black msm disproportionately since the beginning of the epidemic. black msm are the only group in the united states with hiv prevalence and incidence rates that are comparable to those in the most affected developing countries. however, the vast majority of hiv prevention intervention for african-americans does not target homosexual men and for homosexual men does not target black msm (millett and peterson ) . thus, the need to focus prevention efforts on the most vulnerable groups remains an issue not just in developing countries. while prevention strategies need to be tailored to the sources of hiv infections in specific contexts, there are several proven prevention strategies that need to be scaled up. the resources for prevention need to be focused according to the specific nature of the epidemic in different settings, as we showed in chap. . figure . shows the source of new hiv infections by region. table . summarizes the coverage levels of several essential prevention strategies and fig. . shows their deployment by region. it is important to emphasize that prevention and treatment are mutually supportive and need to be addressed simultaneously. access to treatment supports prevention by reducing risky behaviors, increasing disclosure of hiv status, reducing stigma and reducing infectiousness (global hiv prevention working group ) . prevention supports access to treatment by reducing the number of people that require treatment, thus making universal access to treat- group ( ) order to enhance the effectiveness of both. ment more affordable. hiv treatment and prevention should be integrated, in hiv prevention strategies fall into four general categories: ( ) prevention of sexual transmission; ( ) prevention of blood-borne transmission: ( ) prevention of mother-to-child transmission; and ( ) social strategies. the strategies for preventing sexual transmission are: ( ) behavioral change programs (to increase condom use, to delay the initiation of sexual behavior in young people and to reduce the number of sexual partners); ( ) condom promotion; ( ) hiv testing (knowledge of hiv status decreases risky behavior); ( ) diagnosis and treatment of sexually transmitted infections (which significantly increase the risk of hiv acquisition and transmission, particularly in the case of genital herpes); and ( ) adult male circumcision (which reduces the risk of female-to-male transmission by about %) (global hiv prevention working group ) . the effectiveness of these strategies varies. the promotion of condoms has been largely successful with respect to commercial sex and casual sex, but condom use remains low within marriage. as we noted in chap. , increasing life expectancy, in areas where it is low due to diseases like malaria, is a cost effective strategy for enhancing behavioral change to lower the risk of hiv infection. a survey by the who, on behalf of the global fund, reviewed anti-malaria operations in ethiopia, ghana, rwanda and zambia. in ethiopia, childhood malaria declined by % and the death rate was cut in half within years of the beginning of the mass distribution of mosquito nets. within a single year, both cases and deaths dropped by twodeaths by a third. in many cases, the distribution of free nets was accompanied by free drugs based on artemisinin, a substance to which the malarial parasite has yet to develop widespread resistance, and spraying ddt inside people's houses. free nets and malaria drugs would bring malaria under control in most of africa at a cost of usd billion (economist ) . these promising results also bode some studies suggest that treating sexually transmitted infections may not rediseases. moreover, as we noted in chap. , oster ( ) argues that the explanation for the substantial difference in the transmission rates between the united tions, which leave open sores from chlamydia, syphilis and gonorrhea that facili-there is significant evidence that male circumcision significantly reduces hiv a similar picture is seen in south and south-east asia, where overall hiv prevalence is much lower, but the countries with highest hiv prevalence have little thirds, in rwanda, and one-third in zambia. in ghana cases fell by an eighth and based on these results, the who believes that a -year campaign that distributes well for hiv prevention. association between the risk of infection with hiv and other sexually transmitted prevent as many as % of new infections over a decade duce hiv transmission significantly (halperin ) . however, there is a strong transmission. box . discusses the relationship between circumcision and hiv/ tate hiv transmission. thus, treating bacterial sexually transmitted infections could states and sub-saharan africa is due to other untreated sexually transmitted infec-male circumcision (papua new guinea, cambodia and thailand) . conversely, hiv prevalence is extremely low in those countries where most men are circumcised (pakistan, bangladesh, indonesia and philippines). there is ecological evidence that prevalence of circumcision is negatively correlated with prevalence of hiv/aids. specifically, there is a strong inverse correlation between the prevalence of circumcision in countries and the prevalence of hiv in those countries. all the highest hiv prevalence countries are those where circumcision is little practiced. in fact, no country with nearly universal circumcision coverage has ever had an adult hiv prevalence higher than %, including higher risk than that in countries with prevalence of around %. this fact is illus- fig. . ecological relationship between circumcision and hiv prevalence. source: bailey ( ) a large, randomized controlled trial in , men between the ages of and years showed that circumcision resulted in a significant % reduction in hiv vulnerability to hiv varies considerably from one epidemic to the next, as do the issues facing vulnerable groups. for example, in a concentrated epidemic, such as in asia and latin america, hiv transmission occurs primarily among vulnerable groups and prevention programs targeted at vulnerable groups would reduce infection (auvert et al., ) . these results were confirmed by two other trials. the way forward prevention, treatment and human rights trated in fig. . . countries such as cameroon, where a survey found sexual behavior to be overall infection. however, in a generalized epidemic, such as in several countries groups, halperin ( ) argues that transmission would continue unabated despite prevention programs targeted at vulnerable groups. however, as we noted in chap. , research regarding the relationship between trade routes, truckers, sex workers and hiv propagation contradicts this idea. in a generalized epidemic, where hiv is spread along trade routes, prevention programs targeted at truckers and sex workers would be effective in bringing down the growth rate of the spread of the disease. having multiple sex partners increases the risk of hiv infection in both concentrated and generalized epidemics, but the impact of this factor on hiv prevalence rates can vary considerably. for example, even though the united states and uganda have similar rates of multiple sex partners, and the number of sexual partners that men and women had over a -year period were much higher in the united states than in uganda, uganda's hiv/aids prevalence rate was about times higher than that of the united states (halperin ). however, as we noted in chap. , a recent study indicates that abstinence-only programs are as effective as providing no information at all when it comes to preventing pregnancies, unprotected sex and sexually transmitted diseases. abstinence-plus interventions, which promote sexual abstinence as the best means of preventing hiv, but also encourage condom use and other safer-sex practices, are more effective than the proven strategies for preventing blood-borne transmission are: ( ) to supply injection drug users with clean injection equipment; ( ) methadone or other substitution therapy to reduce drug dependence; ( ) blood safety programs, including screening of donated blood; and ( ) infection control in health care settings, including injection safety and antiretroviral treatment following exposure to hiv. as we noted in chap. , the risk of aids infection through the use of blood products was recognized as early as , but countries were slow to adopt measures to ensure the safety of the blood supply and the world health organization (who) passed a resolution on blood products that made no mention of aids as late as january . in the s, chinese health authorities promoted bloodselling by poor farmers to commercial blood collection centers, despite warnings from the who, spreading hiv/aids through the blood fractionation and reinjection process. in , new hiv infections through hospital blood transfusions continued to be reported in china, and illegal underground blood collection centers have continued to operate. box . recounts the story of the libyan scandal over blood-borne transmission to children. in southern africa, where hiv transmission occurs primarily outside vulnerable abstinence-only programs (underhill et al., ) . on december , , sixth sense productions, inc., an independent holly-snezhana dimitrova, valentina siropulo) and a palestinian medical intern (ashraf ahmad djum'a al-hadjudj) who were jailed in libya and faced the death penalty for allegedly infecting children with hiv. this news item is a postscript to a long international drama that began to unfold in when the medics were arrested on charges of injecting libyan children with hiv-tainted blood while at a benghazi hospital. of them, over had died by the end of . one important report was submitted by luc montagnier and vittorio colizzitwo leading experts on hiv/aids. their report concluded that the infection at the infections began before the arrival of the nurses and doctor in . through hospital records, and the dna sequences of the virus, they traced it to patient n. who was admitted times between and in ward b, iso and ward a. the first cross-contamination occurred during that patient's admission. montagnier and colizzi both testified in person at the trial of record for the defense. on that the strain of virus was already present before the arrival of the six accused. the accused were tried and retried. the libyans had signed confessions from them -which the accused said were extracted under torture. the final verdict in sentenced them to death by firing squad. the libyan president likened the scotland for the bombing of pan am flight over lockerbie, scotland, on and political favors in exchange for the release of the six. in the end, bulgaria, qatar and a group of european countries funneled usd million into the international fund benghazi to finance the treatment of the hiv-infected children and the improvement of the libyan health care system. france played a pivotal role in the final release of the accused. in exchange for the release, france agreed to sell antitank missiles and nuclear technology to libya. it was a win-win deal for france: they did multi-million dollar business with libya and got publicity for helping the release of the accused. when the nurses returned to bulgaria, the government endorsed a , leva reimbursement for each of the nurses. a bulgarian mobile telephony provider donated an apartment for each nurse. the way forward prevention, treatment and human rights december , nature ( , - ) published a report that also concluded wood producer, announced plans to make a usd million movie about five event to the case of abdel basset ali al-megrahi, who is serving a life sentence in hospital resulted from poor hygiene and reuse of syringes. they concluded that the bulgarian nurses (kristiyana vulcheva, nasya nenova, valya chervenyashka, december . thus, it became clear that libya was trying to extract economic the proven strategies for preventing mother-to-child transmission are: ( ) general hiv prevention for women of child-bearing age; ( ) a brief course of antiretroviral treatment in advance of delivery (which can reduce transmission by %, but is only received by an estimated % of women in need); ( ) prevention of undesired pregnancy in hiv-positive women; ( ) breast-feeding alternatives; and ( ) cesarean delivery where the mother has a high viral load (global hiv prevention working group ) . in developing countries, a small but growing number of children are dying of hiv/aids. as fig. . shows, some % of children died of hiv/aids in . hiv infected mothers carry additional risks for the baby. in table . , we indicate some of the major risks. some risks like stillbirth or high infant mortality have been found only in developing countries but not in developed countries. for these additional risks, it has been suggested that one way of eliminating vents mother-to-child transmission by %. thus, family planning could also help to reduce mother-to-child transmission: o t h e r ( % ) mother-to-child transmission is not to have the baby in the first place. this pre-another often neglected aspect of hiv prevention -one prohibited from funding by the bush administration's international aids programinvolves expanding family planning services, including for hiv-positive women who do not want to conceive. reducing unintended pregnancies could greatly decrease the number of infected infants as well as the number of children who eventually become orphans (halperin ). if an hiv-positive woman gives birth to a child, there is a risk of transmission of hiv itself, in addition to the other risks listed in table . . however, the transmission risk of hiv from mother to child is not %. it can be minimized through drug treatment of the mother and careful birthing. figure . clearly demonstrates this fact, using the data from the united states. the introduction of zidovudine (for the mothers before childbirth) has dramatically reduced the risk of hiv infection of the baby. since , most countries have applied a regimen of zidovudine from weeks, with nvp administered during labor and to the baby, and the addition of a day zidovudine/lamivudine postpartum regime. the result has been a dramatic reduction of infected newborns (see fig. . ). note that the reduction has been evident in europe and the united states since , when this regime was introduced. in thailand, the regime was introduced in and in most parts of africa years later. once a child is born, the question is whether the infected mother should breastfeed the child. on the one hand, unaids estimated that globally there are , babies infected through breastfeeding. on the other hand, the unicef estimates that , , children die every year from lack of breastfeeding by the breastfeed the baby. key factors that increase vulnerability to hiv include: ( ) gender inequality (which reduces women's access to information and services, reduces power to negotiate safe sex with partners, increases the risk of sexual violence and may create the need to depend on sex for economic survival); ( ) institutionalized discrimination against vulnerable groups (such as criminalizing drug use and needle possession, commercial sex work and sex between men); ( ) poverty (which reduces access to information and services and access to prevention tools, such as condoms); ( ) hiv stigma (which discourages individuals from seeking testing, disclosing their status, seeking hiv-related services or using alternatives to breast-feeding); and formation and social support by displacing populations and increase the risk of sexual violence) (global hiv prevention working group ). as we noted in chap. , there is no clear evidence that reducing poverty and income inequality will necessarily reduce hiv/aids prevalence. moreover, povcondoms and circumcision. significant percentage of men who have sex with men are hiv-infected in many africa; % in guyana; % in st. petersburg, russia; and % in urban ethiobetween vulnerable groups and the general population in bangladesh. the linkages between vulnerable groups, and between vulnerable groups and the general social strategies that address the factors that increase vulnerability to hiv innities and hiv-positive individuals in hiv/aids programs; ( ) visible political leadership; ( ) engaging a broad range of sectors in hiv awareness and prevention the way forward prevention, treatment and human rights hiv/aids prevention strategy. thus, if poverty reduces access to information and parts of the world ( % in bangkok; % in phnom penh; . % in urban sene-vulnerable groups are not compartmentalized. people infected through injection drug use can infect their sexual partners. a significant percentage of men who their clients, who in turn may infect their spouses or other sexual partners. in would be to find innovative ways to improve access to information, provide funding measures; ( ) gender equity initiatives to empower women; ( ) involving commution working group ). human rights are the core of most social strategies to gal; and % of african-american men in five us cities). sex workers can infect many areas, sex workers have very high rates of hiv infection ( % in south have sex with men also have sex with women (for example, % in asia) and a ( ) conflict and humanitarian emergencies (which reduce access to services, inerty reduction is too broad a goal to constitute what might be considered a concrete programs; and ( ) legal reforms to support hiv prevention strategies, such as laws clude: ( ) hiv awareness campaigns, including in the mass media; ( ) anti-stigma services and access to prevention tools, such as condoms, a concrete policy response to enhance access to services and provide free access to prevention tools, such as pia) (global hiv prevention working group ). figure . shows the linkages decriminalizing needle possession and anti-discrimination laws (global hiv preven-population, make effective prevention strategies for vulnerable groups essential. awareness of hiv status has a significant impact on rates of hiv transmission. when unaware of hiv seropositivity, the transmission rate is estimated at . - . the transmission rate to an estimated . - . % (holtgrave ). however, inorder to balance the need for more testing with the need to respect human rights, it has been recommended that health care providers offer and recommend hiv testing, in conjunction with counseling (the opt-in approach), rather than rely on the client to initiate this process. however, mandatory hiv tests and routine hiv testand confidentiality (jürgens ). the major barriers to increasing hiv prevention are: ( ) failure to target limited funding where it will have the greatest impact, due to ing unless the client opts out risk violating individuals' rights to informed consent lack of information on the nature of the epidemic or ideological, non-scientific creasing access to hiv testing and counseling also raises human rights issues. in increases in funding; ( ) failure to integrate hiv prevention in schools, workplaces and other health care programs, such as tb and reproductive health; and ( ) stigma and discrimination against hiv-positive people and vulnerable groups, which deter people from seeking testing and prevention services and discourage political leadership (global hiv prevention working group ) . we analyze the problems and solutions regarding stigma and discrimination against hivpositive people and vulnerable groups later in this chapter. we analyzed the issues of inadequate financing, targeted financing and donor coordination in chap. . as we noted in chap. , a lack of donor coordination is an obstacle to expanding treatment and prevention programs, due to the administrative burden that it imposes on recipients. as we noted in chap. , the us government's foreign aids program, pepfar, devotes only % of funding to prevention and requires that two-thirds of that amount be spent on abstinence-only programs that do not promote condom use, despite evidence that this approach to prevention is not effective and undermines best practices. pepfar guidelines also undermine hiv/aids prevention by further stigmatizing sex workers and prohibiting funding of needle exchange programs, despite evidence that such harm reduction programs are effective. the pepfar approach assumes that vulnerable groups do not interact with the rest of society. pepfar is perhaps the best example of ideological, non-scientific restrictions on the use of donor funding, although it also serves as an example of two of the other significant barriers to hiv prevention, due to its promotion of stigma and discrimination against vulnerable groups and the percentage of funding that it allocates to prevention. however, it is important to emphasize that pepfar has done more than any other bilateral funding program to address the need for adequate financing. the key point is that the money that has been made available through pepfar could be better spent. on december , us president bush signed legislation that lifted a ban that had made washington, dc the only us city barred by federal law from using municipal money for needle exchange programs. officials of the district of columbia health department planned to allocate usd million for such programs in (urbina ) . extending this change in policy to pepfar would enhance the effectiveness of prevention programs in the countries that receive pepfar funding. in chap. , we provided an overview of the history of drug developments to treat hiv/aids and saw the dramatic impact on survival of triple combination therapy. without this treatment, the chance of surviving years was about %. with this treatment, patients have a % chance of living another years. in the early s in the united states, the leading causes of death among - old year men come the leading cause of death in this group. following the introduction of universal access to triple combination therapy, deaths from aids fell to fourth place, behind accidents, cancer and homicide. as a result, whereas % of americans considered hiv/aids to be the most urgent health problem facing the united ents became so important, as we saw in chaps. and . this is also why access to there are five classes of anti-hiv drugs, which are known as antiretroviral verse transcriptase inhibitors (nnrtis), which began to be approved for use in , stop hiv from replicating within cells by inhibiting the reverse transcriptase protein. ( ) fusion or entry inhibitors prevent hiv from entering human immune sert its genetic material into human cells (http://www.avert.org/introtrt.htm). hiv-positive people are prescribed antiretroviral therapy once the number of cd cells falls below a certain threshold or when they develop clinical aids , an international panel of experts continued to recommend these guidelines in low-and middle-income countries, which represents % of those in need (who/unaids progress report on universal access to treatment). the " by lion people on arv therapy by the end of . during this period, the number of people in low-and middle-income countries receiving arv treatment increased from , to . million (who ) . and human resources, management capacity and the ability to identify new patients through testing and counseling (chai ) . in chap. , we examined multilateral funding programs that address these capacity constraints in developing ing treatment are just that -estimates. as we have noted, unaids hiv/aids estients that have been identified as requiring treatment. the reluctance of the united states to allow pepfar funding to be spent on who-approved drugs has also been criticized as an obstacle to expanding treatturer, cipla, created a triple-combination drug in a single pill (triomune) that could be taken twice daily, which it offered to sell for about usd per patient per year in . cipla's triomune offer made the by initiative a realizable goal and cipla has the production capacity to produce four million doses of triomune per day. the who approved triomune in december as a first-line treatment for hiv/aids (hamied ) . the pepfar restriction on the use of who-approved drugs had the effect of preventing the use of pepfar funding to buy triomune. moreover, the majority of pepfar funds have been used to purchase patented versions of hiv/aids drugs, rather than generic versions (see chap. ). figure . shows how generic competition has lowered the cost of triple combination antiretroviral therapy. between and , the price of the generic drugs has brought down the price of the originator substantially -from over usd , to under usd . at the same time, the generic prices have stayed in the - % range of the originator price. pepfar funds can be used to purchase other low-cost generic equivalents of several patented hiv/aids drugs, including some produced by cipla. pepfar requires that generic drugs be approved by the us fda, canada, japan or western europe to be eligible for funding (see chap. ). if us fda approval is sought for fixed dose combinations of previously approved antiretrovirals for the treatment of hiv, if one or more of the approved drug components are covered by a patent, the fda cannot approve an application until the patent expires. however, the application can receive tentative approval (which recognizes that at the time the tentative approval action is taken, the application meets the technical and scientific requirements for approval, but final approval is blocked by patent or exclusivity). products that receive tentative approval are eligible for procurement under the table . . lists the generic versions of hiv/aids drugs that have been approved by the fda for purchase with pepfar funds, along with the generic companies that own the patents for the specific generic formulations and the country of manufacture. the fact that the patents for hiv/aids drugs are owned by different companies has delayed combining different hiv/aids drugs in a single pill in markets protected by patents. one such pill, atripla, was created through a joint venture between merck and bristol-myers squibb with gilead sciences and combines efavirenz (bristol-myers squibb, merck) with emtricitabine and tenofovir (gilead sciences) (ib times ). atripla was approved for sale in the united states in , several years after the indian generic manufacturer, cipla, had started manufacturing a triple-combination pill and years after cipla's pill was approved by the who. approval to market atripla in the european union was sought in december . gilead sciences and merck have formed a joint venture to market atripla in developing countries (ib times ). table . shows the us patents, patent owners and patent expiry dates for selected hiv/aids drugs. zidovudine was the first drug to be approved for treatment of hiv infection. as table . shows, the patent for zidovudine expired in and the patent for lamivudine expires in . however, glaxo extended the life of these patents to by combining the two drugs into one pill (called combivir). while the new combination reduces the number of pills that a patient needs to take, it did not involve the invention of any new chemical entities. the patent history of zidovudine has been cited as a classic case of "evergreening" -the use of the patent system to extend drug monopolies far beyond the term of the original patent (hamied ). box . discussed evergreening. zidovudine was originally synthesized in , as a potential cancer treatment. research in showed that it was effective against hiv/aids, which formed the basis for glaxo's patent application. following clinical trials, the us fda approved zidovudine in march for advanced hiv disease in adults and the patent for zidovudine as a treatment for hiv/aids was granted in february (cochrane ) . while zidovudine alone only extended life by a matter of months, once it was combined with two other classes of hiv/aids drugs, it extended life for years. the fda expanded zidovudine approval in to include evergreening is a mechanism by which pharmaceutical and other companies can keep extending patents on drugs after the initial patents expire. over a fixed period of time. the intention of providing a monopoly is to provide an incentive to innovate. granting a patent requires three elements: ( ) novelty of the product. product; ( ) non-obviousness of the new product; and ( ) demonstrated utility of the the role of patents is to give exclusive rights to manufacture the patented product less-advanced stages of hiv disease (coffey and peiperl, ) . to understand evergreening in the united states, we need to examine the drug price competition and patent term restoration act, informally known as the "hatch-waxman act" . it is a united states federal law which established the modern system for generic drug approval. hatch-waxman generic. section ( j)( )(b)(iv), the so-called paragraph iv, allows -day exvolume). for pharmaceutical companies, the hatch-waxman act has created a perverse drugs by making marginal changes than to try the risky strategy of inventing completely new chemicals. thus, the two decades following its passage, the hatch-waxman act has resulted in more me-too drugs than drugs with new chemical case of prilosec -the so-called "purple pill" of astrazeneca (usd billion/year global blockbuster drug), the patent for which expired in only to be reincarnated as a new patented drug nexium. however, on april the supreme court of the united states issued a ruling in ksr international co v. teleflex et al., which raises the bar for patent holders to prove that their invention is not obvious, and therefore patentable. this ruling will make many existing patents more vulnerable, make it harder to gain approval for new patents and make evergreening more difficult in the future. if the patent claim extends to what is obvious, it is invalid. for example, a patent's subject matter can be proved obvious if there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patent's claims. the supreme court noted that, "granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may, in the case of patents combining previously known elements, deprive prior inventions of their value or utility." it is worth quoting in full the court's description of the reason that patents are only granted for non-obvious innovations: "we build and create by bringing to the tangible and palpable reality around us new works based on instinct, simple logic, ordinary inferences, extraordinary ideas, and sometimes even genius. these advances, once part of our shared knowledge, define a new threshold from which innovation starts once more. and as progress beginning from higher levels of achievement is expected in the normal course, the results of ordinary innovation are not the subject of exclusive rights under the patent laws. were it otherwise patents might stifle, rather than promote, the progress of useful arts." the way forward prevention, treatment and human rights ents for branded counterparts. the hatch-waxman act encouraged the growth of generic industry, whose market share rose from % in to % in (by amended the federal food, drug, and cosmetic act. section ( j) sets forth clusivity to companies that are the "first-to-file" an anda against holders of pat-the process by which would-be marketers of generic drugs can file abbreviated incentive. it has given them more incentive to try to extend the life of existing abbreviated new drug applications (andas) to seek fda approval of the compounds. the most famous documented case of evergreening occurred in the who guidelines for arv treatment regimens provide a basis for a range of treatment protocols in individual countries. in individual countries, factors such as prices, drug efficacy and side effects are also taken into account. stavudine (d t) recommended that d t no longer be used, due to toxicity. instead, countries should switch to tenofovir (tdf) or zidovudine (azt). of these two, tdf is preferable, because of its efficacy and safety and because it can be taken only once a day. emtricitabine (ftc), in one, triple-combination pill that can be taken once a day. patients are more likely to adhere to this once-a-day regimen, thereby reducing azt and tdf, compared to d t, has delayed the shift to the new regimen in many below), the clinton foundation hiv/aids initiative (chai) has negotiated price reductions for several hiv/aids drugs for use in low-and middle-income countries (see table . ). the clinton foundation is discussed in chap. . as of may , , people were benefiting from medicines purchased under chai agreements in countries (chai ). table . . first, the prices are generally higher for middle-income countries than for low-income countries. thus, the pharmaceutical companies are pursuing a price discrimination strategy across different markets, selling drugs at a price that the markets can bear. therefore, there is clear room for generic products in these markets, especially for the low-income countries. compulsory licensing is a distinct possibility (see, however, our discussion in chap. about the difficulties many developing countries faced importing drugs under compulsory license from canada). some companies have used the world bank's country income index or the human development index as their criteria for setting prices. in chap. , we developed a much more comprehensive index that takes into account not just the level of development of the country but also level of prevalence of hiv/aids explicitly. second, the price of hiv/aids drugs in many cases in many developing countries is not necessarily lower than in developed countries. for example, in guatemala, between and , prices of most hiv/aids drugs were consistently higher than in the united states (hellerstein ). according to chai, in , , ( %) of those receiving arv treatment in low-and middle-income countries were taking second-line treatment. the reason that relatively few are on second-line treatment is that most only began treatment within the last years. as a result, relatively few have experienced treatment failure, which is defined as ( ) virologic failure (a viral load of more than copies per milliliter), ( ) immunologic failure (a declining cd cell count in spite of treatment) or ( ) clinical failure (progression to aids evidenced by weight loss or the appearance of opportunistic infections). another reason is that poor diagnostic and laboratory capacity in many countries has made treatment failure difficult to diagnose. by , chai estimates that close to , people will require second-line treatment in low-and middle-income countries (chai ) . the higher cost of second-line treatment means that access requires further funding. however, patents are not expected to be an obstacle to acquiring affordable second-line treatments in the most affected low-income countries, due to the delay of trips patent rules on pharmaceuticals to , although patent rules may affect affordability in middle-income countries (chai ) . in chap. we analyzed trips rules on patents for pharmaceuticals in developing countries. however, as we noted in chap. , the problem of regulatory capture in free trade agreements can undermine trips rules so that patents create obstacles to affordable treatment in some lowincome countries and political pressure on low-and middle-income countries can discourage the use of trips flexibilities to increase access to treatment. unitaid is a global health initiative for hiv/aids, tuberculosis and malaria that is funded by several national governments. with respect to hiv/aids, unitaid funding is focused on pediatric and second-line treatment and the prevention of mother-to-child transmission. unitaid will finance a free supply of second-line hiv/aids treatment in countries for months, after which the reduced prices achieved by chai will enable other funding sources, such as the global fund (discussed in chap. ) and pepfar (discussed in chap. ), to fund the purchase of second-line treatments at lower prices (chai ) . while high-income countries and middle-income countries with low prevalence rates are in a position to pay for hiv/aids treatment, middle-income countries with high prevalence rates and most low-income countries are not. low-income countries with high prevalence rates in particular will have to depend on external funding sources, such as pepfar and the global fund, to expand access to treatment and then to maintain treatment. medical care for people with hiv/aids in developing countries costs about usd , a year, in drugs and support facilities. the economist estimated that it would cost usd - billion a year to provide treatment for the - million people with hiv/aids in low-income countries that were in need of treatment in . however, expanding treatment means that fewer people will die. moreover, millions more will become infected, and even more so if prevention efforts are not improved. thus, universal treatment in lowincome countries could cost usd billion by the end of the next decade. this highlights the need to ensure that external funding is both increased and sustained and the importance of prevention in making universal access to treatment affordable (economist ). scientists have been trying to develop an hiv vaccine for more than years, although some have suggested that an effective aids vaccine may be a biological impossibility (epstein ) . in , about experimental hiv vaccines were being tested in clinical trials. most viral vaccines work by generating antibodies that neutralize or inactivate the invading virus. however, unlike other viruses, hiv- evades the antibody response, which, together with the large genetic variety found in hiv- strains, has made the development of an hiv- vaccine difficult. to date, antibody-based hiv- vaccines have only succeeded in neutralizing a minority of the copies of the virus that are found in a given patient. hiv- antibodies target the mechanism that hiv- uses to bind itself to the host immune cells in order to prevent hiv- from entering the cell. however, hiv- uses shielding mechanisms to prevent the antibodies from recognizing the virus, including a dense coating. current hiv- vaccine research therefore seeks to find vulnerabilities in these shielding mechanisms, but this requires research for multiple genetic subtypes of hiv- (montefiori et al., ) . for example, one recent study identified a place on the outside of the human immunodeficiency virus that could be vulnerable to antibodies that could block it from infecting human cells, which might be targeted with a vaccine aimed at preventing initial infection (dunham ) . a new class of hiv vaccines was designed to trigger cell-mediated immunity to create an extended immune defense. however, in , merck reported that its hiv vaccine, v , had failed. v was being tested by merck and the us national institutes of health in a clinical trial involving , people in highrisk groups in australia, brazil, canada, the dominican republic, haiti, jamaica, peru, puerto rico and the united states (associated press ). v used the common cold virus (the adenovirus) to transport three synthetic hiv genes into the body's cells (park ) . merck halted the trials after of volunteers who got the v vaccine later became infected with hiv, while only of participants that received a placebo also became infected (associated press ). the v vaccine was one of only two aids vaccine candidates in advanced human trials, the other being tested by sanofi-aventis sa (dunham ) . other approaches are also being explored. david ho (the inventor of triple combination therapy) and his team at the aaron diamond aids research center are researching the use of different vectors, or not using vectors at all, to produce stronger immune responses. scientists at the international aids vaccine initiative are studying the use of crippled, live strains of hiv and ways to stimulate a special class of antibodies that appear to be able to defuse hiv. the global hiv vaccine enterprise, which is funded by the gates foundation (discussed in chap. ), wellcome trust, the us national institutes of health and the european union, is seeking to accelerate research on hiv vaccines by linking together independent organizations so that researchers can learn from each other, rather than work in isolation (park ). as we noted in chap. , there are many subtypes of hiv- (the most commonly occurring hiv infection in humans). the major hiv- subtypes accounting for most infections in africa are subtype c in southern africa, subtypes a and d in eastern africa, and circulating recombinant form _ag (crf _ag) in westcentral africa (peeters and sharp ) . the most commonly occurring form of hiv- in north america and in europe is subtype b. the first hiv/aids vaccine ever to reach phase iii trial was for subtype b. the gp vaccine was not effective. however, what vaccine trials have indicated thus far is that, in the case of hiv/aids, there is pattern of development of potential vaccines not in the subtypes where the needs are the greatest but in the area where the biggest monetary rewards are expected. the economics of hiv/aids vaccines suggest that funding for vaccines for the worst-effected countries are unlikely to come from the private sector (see box . ). hiv/aids affects hundreds of millions and kills several million people every year. the disease was identified several decades ago. two nobel prizes have been awarded in the past two decades for identifying the cause and the transmission mechanism of hiv/aids. yet we still do not have a vaccine for hiv/aids. kremer and snyder ( ) have developed an argument as to why the private sector is very unlikely to develop a vaccine for aids. here, we illustrate the argument with one example. imagine there are people in the world. there are people (type l) who have a small chance of % of contracting hiv/aids. there are another ten people (type h) who would develop hiv/aids with a % chance. let us suppose that the harm from hiv/aids is usd for each person. let us also assume that for each usd decrease in harm, a consumer is willing to pay usd (technically, each consumer is risk neutral). suppose the drug is perfectly effective, has no side effects and is costless to produce. how much revenue will a pharmaceutical company generate in each of the following scenarios? ( ) it develops a drug d that cures hiv/aids (forever). ( ) it develops a vaccine v that prevents hiv/aids from developing. we show that under the assumption that the pharmaceutical company cannot distinguish between type h and type l, it is more profitable for the drug companies to produce the drug rather than the vaccine. if the pharmaceutical company develops the drug d, it will be able to sell it to all the people who get hiv/aids. by assumption, all the type h people will develop hiv/aids. thus, there will be ten people from type h who will get hiv/aids. in addition, nine people of type l will also develop hiv/aids. in total, there will be people with hiv/aids, including both types. by assumption, each person contracting hiv/aids will be willing to pay usd to reduce the effects of hiv/aids by %. therefore, the pharmaceutical company will be able to earn usd , in revenue from the entire population. given our assumption of zero cost of production, usd , will also be the profits of the pharmaceutical company. the vaccine has to be sold before hiv/aids strikes. for type l, there is a % chance of hiv/aids. thus, they will be willing to pay the average loss of ( / ) = usd for the vaccine. if the pharmaceutical company cannot distinguish between type l and type h, it can only charge usd to all. in that case, it will generate usd = usd , profits by selling the vaccine to all people. the other possibility is the following. the company sets a price of usd for the vaccine. in that case, no person of type l will buy the vaccine ex-ante (as their expected benefit before hiv/aids strikes is usd but the cost is usd ). the only people who will buy the vaccine will be of type h. since there are ten of type h, the profits will be usd = usd , . thus, in either price strategy, the profits of the company will be usd , . therefore, the profits of the company are bigger in the case of the development of drug d instead of the vaccine v. this argument is extremely general as long as the probability of the type l does not get close to the probability of type h getting the disease and the company cannot distinguish between the types. at the beginning of this book, we highlighted the need to integrate three interrelated issues into any comprehensive aids strategy -prevention, treatment and human rights protection. as we showed in chap. , each of these issues must be considered in the context of specific countries or regions, in order to take into account variations in cultural values, affected groups, infection rates, legal systems, economic resources and human resources. in this chapter, we have analyzed prevention and treatment issues in greater detail. the preceding discussion shows that great progress has been made on these two fronts and that greater progress is possible. our analysis of prevention issues in particular has shown the need to integrate prevention, treatment and human rights strategies. the primary reason that human rights need to be addressed is because discrimination keeps people away from both prevention and treatment programs (gruskin et al., ) . changing social attitudes in order to overcome stigma and discrimination is not an easy task, particularly given deep-seated fears and prejudices surrounding sex, blood, disease and death and the wide-spread perception that hiv/aids is closely supportive and enabling environment for women, children and other vulnerable to change attitudes of discrimination and stigmatization associated with hiv/aids variations in cultural values and legal systems make hiv/aids-related human rights particularly difficult to tackle on a global basis. however, hiv/aidsrelated human rights are the area where the least progress has been made and need to become a central focus in the global fight against hiv/aids (jürgens and cohen ) . in this section, we focus on three categories of laws: ( ) laws that discriminate against vulnerable groups; ( ) laws that discriminate against hiv-positive people, such as those that criminalize hiv transmission; and ( ) laws that prohibit discrimination against vulnerable groups, including hiv-positive people. we review the united nations international guidelines on hiv/aids and human rights and provide examples in each category. the way forward prevention, treatment and human rights to understanding and acceptance (united nations ). groups. the guidelines also recommend that states promote the wide and ongoing distribution of creative education, training and media programs explicitly designed united nations international guidelines on hiv/aids and human rights redialogue, specially designed social and health services and support to community commend that states, in collaboration with and through the community, promote a groups by addressing underlying prejudices and inequalities through community tied to deviant or immoral behavior (jürgens and cohen, ) . in this regard, the the law plays different roles with respect to infectious diseases. some health risks, such as poor access to sterile injection equipment, can be directly attributed to law, and laws have been used to change unhealthy behaviors, such as smoking and drunk driving. both international and national laws are used in disease control. in addition to the law's role as a source of disease control authority for government, the law has a countervailing role as a source of protection against excessive and unnecessary regulations (burris ) . the united nations international guidelines on hiv/aids and human rights acknowledge the inherent limitations in using law reform to enhance human rights. the effectiveness human rights laws depend on the strength of the legal system in a given society and on the access of its citizens to the system, both of which vary considerably from one country to the next. moreover, the law cannot serve as the only means of educating, changing attitudes, achieving behavioral change or protecting people's rights. nevertheless, since laws regulate conduct between the state and the individual and between individuals, they can either support or undermine the observance of human rights, including hiv-related human rights (united nations ) . for these reasons, we first consider laws that support human rights. while social attitudes may take time to change, an important first step is to reform laws, policies and practices that institutionalize discrimination against the groups of people who are most vulnerable to hiv/aids: women and girls; men who have sex with men; commercial sex workers; and injection drug users. the united nations international guidelines on hiv/aids and human rights recommend consistent with international human rights obligations and are not targeted against vulnerable groups (united nations ). laws in this category include those that prohibit sexual acts between consenting adults in private, laws prohibiting sex work that involves no victimization and laws prohibiting measures such as needle exchange that can reduce the harm associated with illicit drug use (elliot ). the united nations international guidelines on hiv/aids and human rights recommend the enactment of anti-discrimination and protective laws to reduce human rights violations against women and children in the context of hiv, to reduce the vulnerability of women and children to hiv infection and to the impact of hiv/aids. with respect to women, the guidelines recommend law reforms to ensure the equality of women regarding property and marital relations and access that states reform criminal laws and correctional systems to ensure that they are have a negative impact on hiv-related human rights and then consider laws that to employment and economic opportunity, such as equal rights to own and inherit property, to enter into contracts and marriage, to obtain credit and finance, to initiate separation or divorce, to equitably share assets upon divorce or separation and to retain custody of children. in addition, laws should ensure women's reproductive and sexual rights, including the right of independent access to reproductive and sexual health information and services and contraception, the right to demand safer sex practices and the right to legal protection from sexual violence. with children against sexual abuse and provide for their rehabilitation if abused and ensexual abuse by their husbands. when the husband is hiv-positive or engages in unsafe sex or drug use, this increases the risk of infection for women. child cusdren make it difficult for women to leave abusive relationships. while statutes allow property ownership regardless of sex, in practice women only have user rights under customary laws, not ownership. under inheritance laws, property remains in the man's family after he dies. thus, if a woman wants to leave an abusive husband or her husband dies, she cannot take any property with her, leaving women economically dependant upon their husbands or, as widows, their families. new laws have created inheritance rights for dependants, but are ignored by the man's family and not enforced. as a result, women and children widowed and women must either rely on their in-laws for support or become commercial sex workers (kelly ) . laws and cultural traditions thus increase women's vulnerability to hiv/aids, either within marriage or by forcing them to support themselves and their children as sex workers. recommend the enactment of anti-discrimination and protective laws to reduce discriminatory property, divorce and inheritance laws for same-sex relationships. the way forward prevention, treatment and human rights tody laws, customary practice and traditions that favor paternal custody of chil-sure that they are not subject to penalties themselves. protection under disability human rights violations against men having sex with men, including in the context orphaned by aids are left without adequate resources for medical treatment, and the united nations international guidelines on hiv/aids and human rights of hiv, including penalties for vilification of people who engage in same-sex respect to children, laws should provide for children's access to hiv-related inlaws, inheritance laws, and child custody laws. in many african countries marital rape does not exist as a legal concept, leaving women with no recourse against formation, education and means of prevention, govern children's access to volcontext of orphans, including inheritance and/or support. laws should also protect untary testing with consent, should protect children against mandatory testing, particularly if orphaned by aids, and provide for other forms of protection in the in sub-saharan africa, laws of particular concern include marital rape, property laws should also be ensured for children (united nations ). one key purpose of such anti-discrimination laws is to reduce the vulnerability of men who have sex with men to infection by hiv and to the impact of hiv/aids. the guidelines also recommend that the age of consent to sex and marriage be consistent for heterosexual and homosexual relationships and that laws and police practices relating to assaults against men who have sex with men ensure adequate legal protection (united nations ). in a internet-based survey of sexually active msm in new york city, % reported being hiv-positive and % reported being hiv-negative. the majority were white, college-educated and in their s. the race of the respondents was white ( %), latino ( %), black ( %) and other ( %). in the previous months, % had more than ten male sex partners, % had engaged in unprotected anal sex and % had used non-injection drugs. fifty percent of the hiv-positive men had unprotected anal sex in the previous months and % of the hiv-negative men had unprotected anal sex in the previous months (nyc health ). in a survey of black msm in new york city, % were hivhigh school education, % were unemployed and % had an annual income of less than usd , . fifty-six percent identified themselves as homosexual, % as bisexual, % as heterosexual and % as other. sixty-five percent had previously been diagnosed with a sexually transmitted infection and % had been raped ( % before they were years old). eighty-four percent knew that they were hiv-positive. of the % that were unaware that they were hiv-positive, % reported having been tested for hiv previously. of those who had never been tested for hiv, the reasons they gave were: ( ) being afraid to learn that they had the perception of not being at risk because they practiced safe sex ( %); and ( ) being afraid that results will be reported to the government ( %). fifty percent reported unprotected anal sex with a man in the previous months and % had exchanged sex for drugs, money or a place to stay in the same period. among those who had unprotected anal sex with a man in their last sexual encounter, % of the hiv-positive men had an hiv-positive sex partner and % of the hivnegative men had an hiv-negative sex partner (nyc health ). according to the unaids guidance note on hiv and sex work, despite high hiv prevalence among sex workers, only one in three receive adequate hiv prevention services and even fewer receive adequate treatment and health care (unaids ) . the unaids guidance note focuses on the reduction of hiv vulnerability among sex workers, who are defined as adults over the age of years in order to take into account that sexual exploitation of children under years of age is prohibited under international law. the key factors that lead people into sex work include poverty, gender inequality, indebtedness, migration, criminal hiv ( %); ( ) being worried that others might treat them differently ( %); ( ) positive. the median age of the respondents was years, % had less than a coercion, humanitarian emergencies, drug use and dysfunctional families. laws, policies and practices that drive sex work underground make hiv/aids prevention and treatment for sex workers and their clients more difficult. discrimination against sex workers among the police, health care services and other social services impede access to prevention and treatment. the unaids guidance note organizes its recommendations into three categories: ( ) reducing vulnerabilities and addressing structural issues; ( ) reducing risk of hiv infection; and ( ) building supportive environments and expanding choices. the strategies in the first category are to: ( ) address poverty and gender inequality by providing alternatives to sex work through micro-finance programs and reforms to property rights; ( ) address the demand for paid sex by seeking to changes men's behavior; ( ) expand access to education for girls and women; ( ) provide alternative job opportunities through employment growth and vocational training; and ( ) provide employment and education opportunities and access to social services for refugees, internally displaced persons and economic migrants. the strategies in the second category are to: ( ) involve sex workers in hiv prevention and treatment programs; ( ) make male and female condoms available for free or at low cost; ( ) increase access to antiretroviral treatment; ( ) address the specific needs of sex workers in sexual and reproductive health programs, taking into account the different needs of female, male and transgender sex workers; ( ) make hiv prevention information and condoms readily available to clients; ( ) seek to eliminate violence against sex workers by clients, managers, police and other government officials; ( ) seek to change attitudes towards sex workers to reduce stigma and discrimination; ( ) promote initiatives to enable sex workers to negotiate safe sex practices; and ( ) promote access to drug addiction treatment programs and harm reduction programs, such as needle exchange. the strategies in the third category are to: ( ) address sex work stigma and discrimination to reduce economic, cultural and social marginalization in families and communities; ( ) improve access to health care, education and training, microfinance and credit, social services, housing support and legal services; and ( ) promote community organizations that work with sex workers. the unaids guidance note on hiv and sex work has been criticized for emphasizing alternative livelihoods without offering concrete examples, rather than emphasizing the right to engage in sex work and workplace safety and national laws that undermine sex workers' rights, particularly criminal prohibition of sex work and related activities. the guidance note's strategy of reducing demand for sex work has been criticized as implicitly supporting the criminalization or repression of sex work, which can increase the risk of hiv infection by driving sex work underground, limit sex workers' choices regarding working conditions and clients and increase stigmatization. the guidance note was further criticized for not advocating enhanced human rights protection for those engaged in sex work -as women, men, transgender persons and workers. the process used for preparing the document was criticized for not meaningfully engaging sex workers. unaids' response to criticism of this document -to withdraw it as a public document and restrict it to internal use -was also criticized (canadian hiv/aids legal network b) the united nations international guidelines on hiv/aids and human rights recommend that criminal law prohibiting sexual acts (including adultery, sodomy, fornication and commercial sexual encounters) between consenting adults in private should not be allowed to impede provision of hiv prevention and care services and should be repealed. with regard to adult sex work that involves no victimization, the international guidelines on hiv/aids and human rights recommend de-criminalizing and legally regulating occupational health and safety conditions to protect sex workers and their clients, including support for safe sex during sex work. more generally, criminal law should not impede provision of hiv prevention and care services to sex workers and their clients and should ensure that children and adult sex workers who have been coerced into sex work are not prosecuted for such participation but rather are removed from sex work and provided with medical and psycho-social support services, including those related to hiv (united nations ). in eastern europe and central asia, unaids ( ) estimates that the use of contaminated injection equipment accounts for more than % of hiv/aid cases and accounts for about % of new infections outside sub-saharan africa. the united nations international guidelines on hiv/aids and human rights recommend that criminal law not be an impediment to measures taken by states to reduce the risk of hiv transmission among injecting drug users and to provide them with hiv-related care and treatment. they further recommend that criminal law be reviewed to consider: ( ) the authorization or legalization and promotion of needle and syringe exchange programs; and ( ) the repeal of laws criminalizing the possession, distribution and dispensing of needles and syringes (united nations ) . in saint petersburg, russia, a study found that % of injection drug users had shared needles in the days prior to their first use of a needle exchange program. in early , there were four syringe exchange facilities in saint petersburg -one mobile service (a bus) and three fixed facilities. however, the most important source of sterile syringes for injection drug users was drug stores. human rights watch found that state-supported impediments to access to both needle exchange points and drug stores were important barriers to hiv prevention, including: ( ) police patrols of drug stores, which deterred injection drug users from purchasing syringes; ( ) police patrols of needle exchange bus stops; and ( ) arrests, fines or bribes for possession of syringes, even though carrying syringes is not illegal in the russian federation. however, while police interference with the syringe exchange bus was a problem in the late s, it lessened in the early s. humanitarian action, an ngo that delivers syringe exchange services in saint petersburg, visited with police chiefs to talk about the importance of syringe exchange for hiv prevention and organized a training session in for police officers that included the participation of former drug users and people living with hiv/aids. however, due to past incidents, the fear of apprehension by the police kept some drug users from using fixed as well as mobile syringe exchange facilities (human rights watch ) . table . shows the dramatic increase in hiv prevalence among injection drug users in saint petersburg from to . a survey of injection drug users (idus) in new york city found that % had obtained a syringe from an exchange program in the previous year, % at a pharmacy, % from a medical provider, % from a friend or sexual partner and % from a drug dealer. the self-reported hiv prevalence rate in the group was %. idus who obtained syringes from sterile sources (exchange, pharmacy or provider) were less likely to share syringes than those who obtained them from non-sterile sources (friends, relatives or the street). those who obtained syringes from exchange programs were significantly less likely to share syringes. nevertheless, % of idus had shared a syringe at least once in the previous months and % had engaged in unprotected sex. idus that had shared a syringe were . times more likely to engage in unprotected sex (nyc health ). another category of laws discriminates directly against people with hiv/aids, such as laws that criminalize hiv transmission and travel restrictions based on hiv status. there is a concern that the criminalization of hiv transmission will discourage people from seeking testing (tarantola and gruskin ) . there is evidence that knowledge of hiv status results in behavioral changes that reduce transmission. in addition, where knowledge of hiv status leads to antiretroviral treatment, treatment also reduces transmission by reducing the amount of virus in the body. thus, the criminalization of hiv transmission may have the effect of increasing, rather than reducing, hiv transmission. one possible response is mandatory hiv testing in health care settings (that is, testing without the informed consent of the patient). however, this policy, too, may be self-defeating if it discourages people from nations international guidelines on hiv/aids and human rights recommendation that public health legislation ensure that hiv testing of individuals should several studies have concluded that the criminalization of hiv transmission is unlikely to serve the goals of public health policy or the goals of criminal law, and ommended that governments and the judiciary take into account the following principles in determining policy regarding the use of criminal sanctions under modes and risk of hiv transmission to rationally determine when and if conduct should attract criminal liability; ( ) the primary objective should be to prevent public health and conform to international human rights norms, particularly nondiscrimination and due process; and ( ) policy makers should assess the impact of law or policy on human rights and prefer the least-intrusive measures possible to achieve a demonstrably justified objective of preventing disease transmission. with respect to the four functions of criminal law (harm prevention through response to the epidemic: ( ) imprisoning an hiv-positive individual does not prevent transmission through conjugal visits or high-risk behavior with other prisoners; ( ) criminal penalties are unlikely to change sexual activity and drug use, due to the complexity of these human behaviors; ( ) punishment/retribution do not achieve the goal of hiv prevention and risk reinforcing prejudice and discrimination against already stigmatized hiv-positive people; and ( ) criminal sanctions are unlikely to act as a deterrent, given that drug use and sexual activity persist even with the risk of criminal prosecution and are more likely to be driven underground when prosecuted, hindering hiv prevention. moreover, overly broad use of criminal laws risks spreading misinformation regarding how hiv is transmitted. in an empirical study conducted in the united states, burris et al. ( ) found that laws prohibiting unsafe sex or requiring disclosure of infection do not influence people's normative beliefs about risky sex and did not significantly influence sexual behavior. the study concluded that criminal law is not a clearly useful in-moreover, given concerns about possible negative effects of criminal law, such as stigmatization or reluctance to cooperate with health authorities, criminal law should be used with caution as a behavioral change mechanism for hiv-positive people. seeking health care. moreover, mandatory hiv testing runs counter to the united thus may do more harm than good. in a unaids policy paper, elliot ( ) bution; and deterrence), elliot ( ) concluded that criminal law is an ineffective imprisonment; prevention of future harm through rehabilitation; punishment/retri-hiv transmission in common law countries. in some cases, courts have applied existing criminal laws to cases involving hiv, where the laws themselves do not refer specifically to hiv. in this context, law reforms could come from the legislature, through amendments that clarify the application of relevant criminal laws to cases involving hiv, or through the evolution of precedents in the courts. the united nations international guidelines on hiv/aids and human rights recommend the reform of criminal laws and correctional systems to ensure that they are consistent with international human rights obligations and are not misused in tization of the judiciary, in ways consistent with judicial independence, on the legal, ethical and human rights issues relative to hiv, including through judicial education and the development of judicial materials (united nations ). criminal laws should not include specific offences against the intentional transmission of hiv but rather should apply general criminal offences to these exceptional cases. such application should ensure that the elements of foreseeability, intent, causality and consent are clearly and legally established to support a guilty verdict and/or harsher penalties (united nations ) . in the united states, a series of cases involving spitting have gone in different directions. in ohio v. bird ( ) , an hiv-positive man was convicted of felonious assault, which requires the knowing attempt to harm by use of a weapon capable of inflicting death, after spitting in a police officer's face, even though all medical and scientific evidence demonstrated that saliva does not transmit hiv. in state v. jones ( ) , another case of an hiv-positive individual accused of spitting on an officer, the new mexico court of appeals ruled that criminal liability for battery could not be based upon the victims' subjective and unsubstantiated fears that they could develop a disease, and reversed the lower court on this issue. in weeks v. state ( ) , the texas court of appeal sustained the attempted murder conviction of an hiv-positive inmate who spat in a guard's face. the spitting cases show how the application of criminal laws to hiv-positive individualswhen based on hiv status, stigma and discrimination rather than on medical or scientific evidence -can undermine genuine efforts to reduce hiv transmission by spreading misinformation and increasing stigma and discrimination. in cases involving behavior that does carry a risk of hiv transmission, such as unprotected sexual intercourse or sharing drug injection equipment, the central issue is consent. in r v. cuerrier ( ) the supreme court of canada established that there is a duty to disclose one's hiv status before engaging in any activity that poses a "significant risk" of hiv transmission. failure to do so legally invalidates a sexual partner's consent to sexual intercourse. the lack of consent to have intercourse with a partner that is hiv-positive converts the sexual intercourse into a criminal assault. in that case, the complainants did not become infected with hiv as a result of the unprotected sex. however, if the complainants believe that their partner is hiv-free and the accused puts the complainants at significant risk to their health, failure to disclose hiv status vitiates consent to sexual intercourse. the way forward prevention, treatment and human rights there have been numerous cases in which criminal laws have been applied to the context of hiv/aids (united nations ). they also recommend the sensi-this decision suggests that there might not be a duty to disclose hiv status prior to engaging in activities that do not pose a significant risk of transmission, such as kissing and oral sex, or where an hiv-positive individual uses a condom. in r v. edwards, a lower court judge ruled that there is no duty to disclose hiv status prior to engaging in unprotected oral sex because it is a low risk activity (canadian aids society ) . on november , the defendant learned that he was hiv-positive, but did not reveal his status to the complainant and continued to have unprotected sex with her. the supreme court of canada ruled that the defendant was not guilty of the act itself, but rather the consequences of the act. because it was likely that the defendant had infected the complainant before he learned of his hiv status, it could not be proved beyond a reasonable doubt that he had endangered the life of the complainant. however, the defendant was guilty of attempted aggravated assault for continuing to have unprotected sex with the complainant after having learned of his hiv status. the court ruled that there is sufficient criminal intent for a conviction on a sexual assault charge if a person acts "recklessly". in canadian law, a person acts "recklessly" if they know that their conduct risks committing a crime but they commit the act nevertheless. in this case, the supreme court ruled that criminal recklessness is established once an individual becomes aware of a risk that he or she has contracted hiv, but continues to have unprotected sex without disclosure of hiv status, thereby creating a risk of further hiv transmission. in this case there was no evidence before the court regarding the defendant's awareness of the risk that he might be hiv-positive, prior to november , other than the fact that he had been asked to take an hiv test. this aspect of the ruling raised the issue of whether there is a duty to disclose the mere awareness of a risk that one might be hiv-positive before having unprotected sex. the court also suggested that an hiv-positive person might be held criminally liable for failure to disclose hiv status before having unprotected sex with another hivpositive individual, where this results in the transmission of a different strain of hiv or a drug-resistant strain of hiv. the supreme court of canada cases have been criticized, on the one hand, for discouraging people from seeking testing in order to avoid the possibility of a criminal conviction based on knowledge of hiv status and, on the other hand, for risking undesirable invasions of privacy if courts are required to determine whether an individual was aware that their past activities put them at risk of hiv infection (canadian hiv/aids legal network ) . however, in r v. williams, the fact that the defendant had been asked to take an hiv test, because he was on a list of former partners provided by an individual who had tested hiv-positive, was not sufficient to establish that he was aware that his past activities had put him at risk in r v. williams ( ) , the defendant began a sexual relationship with the comthe complainant". what distinguishes aggravated assault from mere assault is not plainant in june , in which they had unprotected sex on numerous occasions. requires that the assault "wounds, maims, disfigures or endangers the life of aggravated assault under section ( ) of the canadian criminal code, which of hiv infection. nevertheless, the decision has been criticized for extending the without defining the nature of the awareness that might be required. more generally, the use of criminal law to prevent hiv transmission has been criticized for stigmatizing all hiv-positive people because of the conduct of a few individuals, for discouraging those most at risk from seeking testing and for being unlikely to stop people from having risky sex or sharing needles and syringes. moreover, all of the hiv-related criminal prosecutions in canada have occurred in the context of heterosexual intercourse, rather than homosexual intercourse or injection drug use, creating a perception of discriminatory application (or non-application) of the laws (betteridge ). sion of hiv/aids between and , in which eight accused pleaded guilty, two were convicted and one was acquitted (klein ) . a new zealand court has ruled that people living with hiv/aids are not required to disclose their hiv status if they use condoms during vaginal sex (klein ) . in particular, the use of criminal laws to prevent hiv transmission also has been criticized for not taking into account that hiv-positive individuals living in abusive relationships may fear the consequences of disclosing their status to partners and may not be able to use a condom or insist that their partner use a condom (canadian aids society ) . in a literature review of hiv/aids and genderbased violence, the harvard school of public health program on international health and human rights ( ) found that gender-based violence (which is not limited to violence against women) can interfere with safe sex practices and access to treatment. not only is gender-based violence a risk factor for acquiring hiv/ in summary, the use of criminal laws to prevent hiv transmission may undermine overall public health initiatives by: ( ) reinforcing hiv/aids-related stigma; ( ) spreading misinformation about hiv/aids; ( ) creating a disincentive for hiv testing; ( ) hindering access to counseling and support services; ( ) creating a false expectation that criminal laws eliminate the danger of unprotected sex for people who believe that they are hiv-negative; ( ) creating the risk of selective prosecution of marginalized groups; ( ) criminalizing behavior that results from gender inequality, in the case of hiv-positive people living in abusive or economically dependent circumstances; and ( ) invading privacy through the disclosure of medical records and hiv status in public court proceedings (elliot ) . however, the use of criminal laws may be warranted in some circumstances, where hiv status is an aggravating or otherwise relevant factor in cases involving physical assault that would constitute criminal behavior even in the absence of hiv, such as rape or the use of needles as weapons (elliot ) . finally, a distinction should be made between criminal laws and public health laws that are quasi-criminal in nature, particularly those regarding quarantine. while quarantine laws, such as isolation, detention or quarantine, may be suitable the way forward prevention, treatment and human rights criminal law beyond cases where individuals know that they are hiv-positive, in the united kingdom, there were eleven prosecutions for reckless transmis-aids, but hiv/aids is also a risk factor for gender-based violence. for casually communicable and curable diseases, such laws run the same risk of misuse as do criminal laws (elliot ) . in this regard, the united nations international guidelines on hiv/aids and human rights recommend that public health law provisions applicable to casually transmitted diseases not be applied inappropriately to hiv/aids and that they be consistent with international human rights obligations (united nations ). some countries have restricted the entry of people living with hiv/aids, for shortterm or long-term stays, through mandatory testing or a requirement to declare one's hiv status. as we saw in chap. , the who international health regulations also contain provisions regarding health measures applied to travelers. these provisions encourage states to base their determinations upon scientific principles, available scientific evidence of a risk to human health and any available specific guidance their dignity, human rights and fundamental freedoms and minimize any discomfort or distress associated with such measures. governments cite two main reasons for imposing travel restrictions on people living with hiv/aids -public health protection and reducing demand on health care and social services (unaids/iom ) . in the united kingdom, another source of demands for hiv screening of migrants has been a concern over "health tourism" -hiv infected migrants from developing countries that go to europe to receive health care. however, research shows that access to treatment is rarely the after having arrived in the host country, and there is no uniform policy in european union countries regarding screening of migrants for hiv (carballo ) . hiv/aids is not considered to be a condition that poses a threat to public health in relation to travel because hiv/aids is already present in virtually every country in the world and hiv is not transmitted through casual contact. unlike highly contagious diseases with short incubation periods, such as sars, cholera and plague, hiv transmission can be prevented through safe sex and safe drug injection, which can be used by both the infected and the non-infected to prevent transmission. there is no evidence to support the assumption that both the infected and the non-infected will engage in unsafe practices. as a result, the presence of hiv-positive individuals, by itself, does not pose a risk to public health. in addition, travel restrictions are not effective in preventing the entry of hiv-positive individuals, since hiv tests do not detect the virus in newly infected people and nationals that are returning from travel abroad (who may have been infected while outside the country) are not subject to hiv/aids-related travel restrictions and are not prevented from entering their own country. moreover, travel restrictions can undermine hiv/aids-related public health initiatives by increasing stigma and discrimination and mislead the public into thinking that hiv/aids can be or advice from the who. they also require states to treat travelers with respect for reason for migration to europe, since most migrants only learn of their hiv status prevented through border measures, rather than through proven prevention strategies (unaids/iom ) . unaids and the international organization for migration (iom) recommend that exclusion on the basis of possible costs to health care and social services only occur on an individual basis, where the following considerations are shown: ( ) the person requires the health care and social services and is likely to use them in the near future; ( ) the person has no other means of meeting those costs (for example, through private or employment-based insurance or personal resources); and ( ) these costs will not be exceeded by the benefits of the person's skills, talents, contribution to the labor force, payment of taxes, contribution to cultural diversity and capacity for revenue or job creation (unaids/iom ) . they also recommend that countries treat similar conditions alike, rather than singling out hiv/ aids. one study showed that the -year economic impact of admitting immigrants with asymptomatic hiv infection would be similar to admitting immigrants with asymptomatic coronary heart disease (zowall et al., ) . the canadian immigration and refugee protection act provides that foreign nationals can be deemed "medically inadmissible" based on a medical condition, danger to public health or public safety; or ( ) they might reasonably be expected to cause excessive demand on health or social services. since , canadian danger to public health or public safety by virtue of their hiv status. the issue of excessive demand on health or social services is mainly a consideration in cases of immigration or stays that exceed months, is determined on a case-by-case basis permanent residents (spouses and children). demand on health or social services of health or social services for the average canadian resident; or ( ) the demand the united states has had a travel and immigration restriction in place for people living with hiv/aids since (human rights watch ) . under the united states are inadmissible if they have "a communicable disease of public high level meeting on aids a "designated event" for which an hiv waiver would be available. visitors entering the united states on the visa waiver program (which waives the requirement to apply for a visa prior to traveling to the united the way forward prevention, treatment and human rights government policy has been that people living with hiv/aids do not represent a and therefore denied a visa or entry at the border, if: ( ) they are likely to be a would add to existing waiting lists for those services and would increase the rate us immigration and nationality act, applicants for a visa or for admission to the health significance", which includes hiv infection, although waivers are available ces by canadian citizens or permanent residents. the social or economic contribu-and does not apply to refugees or close family members of canadian citizens or tions the individual is expected to make to canada are not taken into account. or mortality and morbidity in canada by denying or delaying access to those servi- hiv status or to be tested for hiv (canadian hiv/aids legal network a) . on a case-by-case basis. for example, the us attorney general named the people entering canada for less than months are not required to disclose their is considered excessive if: ( ) the anticipated costs would likely exceed the costs states, for certain countries) must fill out an i- w form, which asks, "have you ever been afflicted with a communicable disease of public health significance." if the visitor answers yes to the question or the us border authorities suspect a visitor to be hiv-positive the person may be: ( ) placed into secondary inspection; ( ) questioned by an official of the us department of homeland security; ( ) placed into deferred inspection; ( ) asked to withdraw the application for admission into the united states; ( ) placed into the expedited removal process; or ( ) placed into an us department of homeland security detention center and detained until the case is heard by an immigration judge (gmhc ) . hiv-positive non-immigrants seeking to enter the us on a temporary basis for business, pleasure, or education are eligible for a waiver under which they can be allowed to enter the united states. in practice, a waiver is granted in most cases if: ( ) they are not symptomatic; ( ) it is a short visit; ( ) they have insurance or other assets sufficient to pay medical expenses; and ( ) they don't appear to be a public health risk. permanent residency and immigration applicants can also apply for a waiver, but they are usually rejected. to receive a waiver as an immigrant, the person must be the spouse, unmarried son or adopted child of a united states citident as their son or daughter. in addition, an hiv-positive immigration applicant must prove that: ( ) he will not be a danger to public health; ( ) the possibility of spreading the disease is minimal; and ( ) there will be no cost incurred by any level of government without its prior consent (tarwater ) . june the us public health service added aids to the list of excludable conditions, noting that the exclusion was not based on any new scientific knowledge and that aids is not spread by casual contact, which is the usual public concept of contagious. in july , republican senator jesse helms also added hiv infection to the exclusion list, through the us congress, together with a prohibition on funding from the us centers for disease control for aids programs that "promote, encourage or condone homosexual activities" (koch ; aids treatment news ) . senator helms accompanied the introduction of his amendments with the following statement: "we have got to call a spade a spade, and a perverted human being a perverted human being" (koch ) . in july , senator jesse helms advocated spending less money on hiv/aids, because it resulted from "deliberate, disgusting, revolting conduct" and was "a disease transmitted by people deliberately engaging in unnatural acts" (associated press ). ten years later, he had this to say: "it had been my feeling that aids was a disease largely spread by reckless and voluntary sexual and drug-abusing behavior, and that it would probably be confined to those in high-risk populations. i was wrong" . in , the us centers for disease control (cdc) recommended that all diseases except active tuberculosis be removed from the list of excludable conditions. hiv was left on the list because it had been put on the list by congress. in november the political history of the us hiv travel restrictions is an interesting story. in zen or permanent resident or have a united states citizen or lawful permanent resi- , the immigration reform act of directed the cdc to establish a new list of excludable conditions, based solely on current epidemiological principles and medical standards. in january , the cdc again proposed that only active tuberculosis remain on the list of excludable conditions. religious leaders campaigned to maintain the ban and the us house of representatives opposed removing the hiv ban (aids treatment news ) . in august , democratic representatives barbara lee and hilda solis introduced the "hiv nondiscrimination in travel and immigration act". the proposed legislation would restore the authority of the secretary of health and human services to determine whether hiv status is a communicable disease of public health significance. the decision to maintain or remove the ban would then be based on public health analysis instead of a formal ban made by congress (latino commission on aids ). in november , the us department of homeland security proposed a new rule that would allow short-term visas to be granted to hiv-positive people by us consulates in their home countries. however, applicants would have to agree to conditions, including ceding the right to apply for longer stays or permanent residency in the united states. democratic members of the us house of representatives objected that the changes would only shift decision-making authority to local consular officers, who may lack the appropriate medical expertise. moreover, there would be no appeal process (werner ) . the united states and canada are similar societies, both culturally and economically, but have adopted very different approaches to hiv/aids travel restrictions. the hiv prevalence rate in the united states is higher than in canada. this suggests that the us travel restriction has not been effective in preventing hiv transmission in the united states, and that the lack of such a restriction in canada has not had the effect of increasing hiv prevalence. health care costs, measured as a percentage of gdp, are also higher in the united states than in canada. while this difference is attributable to many factors, making it difficult to determine the impact of the different travel restriction policies on health care costs without further study, it is an indication that the canadian approach has not led to a significant increase in health care costs compared to the american approach. in , americans spent usd , per capita on health care, compared with usd , in canada. americans spent . % of gdp on health care compared with . % of gdp in canada. interestingly, this gap was not always there. in , both countries spent exactly . % of their respective gdp on health care (oecd ) . another factor that suggests that us travel restrictions are unlikely to prove successful is illegal immigration. there are several million illegal entries into the united states each year. they are obviously not screened. thus, from a practical point of view, travel and immigration restrictions for hiv-positive individuals are unlikely to be effective in preventing the entry of many hiv-positive individuals and may provide additional incentives for some individuals to migrate illegally. the united nations international guidelines on hiv/aids and human rights recommend that states enact or strengthen anti-discrimination laws that protect vulnerable groups, people living with hiv/aids and people with disabilities from discrimination in both the public and private sectors, and provide for speedy and effective administrative and civil remedies (united nations ). human rights laws in many jurisdictions prohibit discrimination against vulnerable groups or against people with hiv/aids, as well as providing other rights that are relevant to hiv/aids, such as the right to life and the right to health. human rights laws fall into two categories. the first category applies to governments, prohibiting governments from passing discriminatory laws or requiring governments to uphold certain human rights. the second category of human rights law prohibits discrimination on the part of private actors, for example with respect to employment practices or rental of housing. while it is not possible to eliminate individual or societal prejudices with legislation, human rights laws provide victims of discrimination with legal recourse against acts of discrimination and create economic disincentives through fines or other legal remedies, thereby contributing to social change. canada provides one example of the sources and functioning of human rights laws. section of the canadian charter of rights and freedoms, which is part of the constitution of canada, guarantees equality rights in the following terms: the equal protection and equal benefit of the law without discrimination and, in particular, without discrimination based on race, national or ethnic origin, colour, religion, sex, age or mental or physical disability. canadian courts have interpreted the term "disability" to include hiv/aids, which means that people living with hiv/aids have constitutional protection listed, but also covers analogous grounds, such as sexual orientation. any law that is inconsistent with constitutional provisions may be struck down or interpreted by courts to make it consistent with the constitution. the charter applies to all levels and branches of government, all government acts, government corporations and ment government policies or programs. however, the charter does not otherwise apply to acts by private citizens. instead, discrimination by an employer, a landlord or a private business is addressed under other federal and provincial human rights laws, such as the canadian human rights act, which apply to both the public and private sectors. by virtue of a policy of the canadian human rights commission and decisions of canadian courts and tribunals, the prohibition against disability-based discrimination in the every individual is equal before and under the law and has the right to against discrimination by the state. section is not limited to the grounds that are private persons or bodies that exercise authority granted by a statute or that imple-canadian human rights act and its provincial counterparts cover discrimination based on hiv/aids status (elliott and gold ) . the remainder of this section provides an overview of court cases in a variety of countries that have applied constitutional law, international law and other legislation to uphold the rights of people living with hiv/aids with respect to employment and access to hiv-related medical care and treatment. in march , mexico's national supreme court of justice ruled that a provision in article of the social security institute law for the armed forces (issfam) that required hiv-positive individuals to be discharged from the military was unconstitutional, because it was not based on an individual assessment of the pering people living with hiv/aids. the court ordered that three soldiers be reinduty, which would include an obligation to reinstate their social security benefits with respect to hiv/aids, laws in south africa and latin america that provide a action campaign used this provision to challenge the government's program that limited the use of nevirapine to prevent mother-to-child hiv transmission to test sites. the court ruled that the government's restriction on the use of nevirapine was unreasonable and that the policy should be reformed to meet the government's constitutional obligation (singh et al., ; elliot et al., ) . in argentina, five court cases between and repeatedly ordered the argentine ministry of health to supply antiretroviral treatment to people living with hiv/aids, in accordance with the right to health set out in international treaties, which had been incorporated into domestic law. the failure of the ministry of health to act in a timely fashion, which led to interruptions in the supply of antiretroviral drugs, ultimately led to a court order that would fine the ministry of health usd , per day (funds which would then be used to implement the national aids plan) until it complied with the courts' previous orders, and the threat right to health care have been used to induce governments to provide access to and equality and was inconsistent with mexico's international obligations regardvides a right to health care that is binding on the government. the treatment mexico's national supreme court of justice ruled for a fifth time that this provision was unconstitutional, thereby creating jurisprudence that is binding on all federal son's ability to work, violated constitutional protections of non-discrimination judges in mexico (avilés allende ). table . summarizes several other antiretroviral treatment (gruskin et al., ) . the south african constitution pro-cases involving hiv-related discrimination in employment from various juris- (pearshouse ; medina and reyes ; scjn a, b) . in september , dictions around the world. stated until medical certificates were issued to determine whether they were fit for (elliot et al., ) . an argentine court also relied on the right to health set out in international treaties to order the government to produce and administer a vaccine within a set period of time, in order to protect people living in a region affected by argentine haemorrhagic fever (singh et al., ) . the constitutional court of ecuador relied on the right to health set out in international treaties to rule that the ministry of health had failed to meet its obligations when it suspended its hiv treatment program (singh et al., ; elliot et al., ) . in costa rica, the supreme court ruled in that the costa rican social security fund could not argue that financial constraints justified failure to comply with its very reason for its existence, which is to provide coverage for necessary medical care. shortly after this ruling, the supreme court ordered the social security fund to develop a plan to provide coverage to all persons living with hiv/aids that were in need of antiretroviral treatment. a few weeks later, costa rica became the first central american country to include cov- ) . in india, the courts have interpreted the right to life in the indian constitution to sources to uphold the right to health in a variety of cases (singh et al., ) . table . summarizes several other cases from various jurisdictions around the world where litigation has increased access to hiv-related medical treatment. these cases suggest that human rights laws can be instrumental in promoting health care reforms through litigation, provided that judicial authorities are independent and competent and governments respect the rule of law (singh et al., ) . in addition to laws that institutionalize or prohibit discrimination, institutional policies and practices can represent an important force with respect to stigma, discrimination and access to health care. the united nations international guidelines on hiv/aids and human rights recommend that states ensure that government and the private sector develop codes of conduct regarding hiv/aids issues that translate human rights principles into codes of professional responsibility and practice, with accompanying mechanisms to implement and enforce those codes. in many jurisdictions, the courts have the power to order changes in policies and practices of both governmental and non-governmental institutions. however, litigation is an expensive and time-consuming process that creates additional stress for the people living with hiv/aids who choose to litigate. thus, it is important to promote the voluntary adoption of appropriate policies and practices. one example in this category is the policies and practices of health care institutions. for example, in the mid s, in british columbia, canada, all hospitals refused to treat aids patients, with the exception of st. paul's hospital, which adopted appropriate policies based on the commitment of the founding sisters of include a right to health, and have obliged the indian government to dedicate re-erage for antiretroviral drugs in its national health insurance plan (elliot et al., another example in this category is the policies and practices of employers. as we showed in chap. , hiv/aids affects the productivity of workers substantially, making it cost effective for companies to have prevention programs and to provide treatment for employees, from a purely financial point of view. business leaders have an economic incentive to invest resources in fighting the epidemic. moreover, as we saw in chap. , firms can have a tremendous impact in promotment. however, it is important to have an overarching framework that ensures the adoption of best practices by individual firms and to minimize overlap between the private sector and the other players that are involved in addressing the pandemic. in this regard, the global business coalition on hiv/aids has provided leadership, particularly in its efforts to identify ways to improve the global business community's response to hiv/aids, including through leadership to dispel myths and stigma, break down workplace barriers and influence community change. given the economic and legal incentives, an effective hiv/aids response the way forward prevention, treatment and human rights providence to care for all who were in need, regardless of financial or social standing (gratham ) . in , the city of philadelphia agreed to resolve a complaint regarding the refusal of emergency medical services personnel to touch or lift a patient because of his hiv status, by paying monetary compensation and agreeing to implement a mandatory paramedic/emt training program on hiv and infectious diseases (john gill smith and united states v. city of philadelphia ) . ironically, "philadelphia" was the name and setting of the first high-profile hollywood film to take aids seriously, in . we can think of hiv/aids as a disaster from the point of view of a country as a whole. unlike other disasters (such as an outbreak of an influenza pandemic), this kind of risk, we need to measure the severity and the frequency of occurrence of that risk. once we measure the risk, we need to find ways of managing the risk in a dynamic way. that means putting a risk management plan in place, monitoring the plan and modifying the plan as events unfold. most often, at the national level, hiv/aids is seen as a public health problem and is managed as such. thus, various measures are taken to reduce the incidence of hiv/aids by taking steps against the main channels through which the disease strikes: ( ) actions to reduce the contamination of the blood supply; ( ) special steps to promote health care for key groups, such as sex workers; ( ) needle exchange programs; ( ) promoting safe sex through the use of condoms; and ( ) minimizing hiv transmission from infected mothers to newborns. disaster unfolds over many years. however, the standard operating procedure for ing prevention among employees and their families and providing access to treatdisaster management also applies to managing hiv/aids risk. for managing any must be a core component of an overall business strategy. another approach to risk management is risk avoidance. at the country level, risk avoidance could imply two extreme actions: quarantining people who are already infected and preventing infected people from coming into the country. neither of these policies is feasible for most countries, as they directly go against human rights. thus, extreme forms of risk management and the respect for human rights pose a tradeoff for a country. cuba provides a striking example of how containment of hiv/aids can be conducted at a national level. cuba started promoting public health messages against hiv/aids in , years before the first hiv case was reported in the country. between and , cuba undertook a massive testing exercise, which tested more than % of the adult population. those who were seropositive were quarantined indefinitely in sanitariums. over the years, cuba has relaxed the rule. today, anybody found seropositive is required to attend an week course. after that, they are free to leave. nearly half the people choose to stay in the sanitariums, where they get free food and a place to stay, along with retraining if they choose to help with the logistics of the sanitariums. such a curtailment of freedom of movement without committing a crime is unprecedented anywhere in the world. it has been criticized by many. it did produce a result that is also unprecedented. cuba has an hiv incidence rate of . %. in the neighboring island of haiti, the rate is times as high, at . %. it should be noted that quarantine of individuals who have committed no crime is not unheard of. there was the case of mary mallon in the united states in better known as the "typhoid mary" -who carried typhoid without every showing any symptoms. she was quarantined against her will for a number of years. similarly, during the outbreak of influenza in the united states in , many families were quarantined on public health grounds. individuals with sars were also quarantined in toronto. the future of hiv/aids presents a mixed picture. while hiv/aids incidence has begun to level off in some high-prevalence countries, new infections have increased in many developed countries. while several science-based prevention strategies need to be scaled up significantly, the increase in mother-to-child prevention has dramatically reduced infections among newborns and male circumcision is a promising new prevention strategy. while millions still lack access to treatment, there has been a large increase in funding, drug prices have dropped dramatically, several key drug patents will expire in the near future and efforts to develop new treatments continue. while stigma and discrimination remain obstacles to effective prevention and treatment, human rights laws have proved to be an effective vehicle for addressing discrimination and increasing access to treatment around the world. thus, while hiv/aids continues to pose a significant threat to public health, there are many signs that progress in fighting this pandemic can and will continue, as knowledge gradually replaces ignorance. travel/immigration ban: background senator jesse helms: cut aids funding experimental aids vaccine falls short randomized, controlled intervention trial of male circumcision for reduction of hiv infection risk: the anrs trial amplía corte protección a militares con vih male circumcision: the road from evidence to practice. division of epidemiology, school of public health, university of illinois at chicago betteridge g ( ) criminal law and hiv transmission or exposure: new cases and developments law as a structural factor in the spread of communicable disease the way forward prevention, treatment and human rights do criminal laws influence hiv risk behavior? an empirical trial hiv disclosure & the criminal law in canada supreme court of canada decision in r v canada's immigration policy as it affects people living with hiv/aids a human rights-based commentary on unaids guidance note: hiv and sex work communicable diseases: challenges for health in the age of migration c fe c/ /chpt eu.pdf. accessed a% human% rights-based% commentary% on % unaids % guidance % zidovudine's patent history look to the future: the war against aids. the economist net benefits: giving bed nets and drugs away free may be the way to deal with malaria criminal law, public health and hiv transmission: a policy options paper protection against discrimination based on hiv/aids status in canada: the legal framework the effect of pregnancy on survival in women infected with hiv: a systematic review of the literature and meta-analysis global hiv prevention working group ( ) bringing hiv prevention to scale: an urgent global priority history, principles and practice of health and halperin d ( ) evidence-based behavior change hiv prevention approaches for sub-saharan africa harvard school of public health program on international health and human rights hamied yk ( ) trading in death lessons not learned: human rights abuses and hiv/aids in the russian federation family, unvalued: discrimination, denial, and the fate of binational same-sex couples under memoir, jesse helms says he was no racist a salute to the sisters. promise fall/winter literature review increasing access to hiv testing and counseling while respecting human rights reasons why human rights should occupy the center of the global aids struggle. open society institute the way forward prevention, treatment and human rights conspiring to kill: gender-biased legislation, culture, and aids in sub-saharan africa new hiv cases drop but rise in young gay men. www.nytimes senator helms's callousness toward aids victims the latino commission on aids supports the hiv nondiscrimination in travel and immigration act discriminación por vivir con vih: fuerzas armadas, a punto del revés, letra s the known hidden hiv/aids epidemic among black men who have sex with men in the united states plos medicine : nyc health ( ) hiv epidemiology and field services research unit report accessed november human rights watch ( ) family, unvalued: discrimination, denial, and the fate park a ( ) assessing a failed aids vaccine mexico: supreme court rules discharge of hiv-positive troops unconstitutional genetic diversity of hiv- : the moving target seeds of change in rwanda sesión pública núm the tuberculosis & hiv debate in immigration law: critical flaws cuerrier ( ) scr , supreme court of canada new mexico court of appeals, nm ohio state court appellate amicus brief us food and drug administration ( ) guidance for industry fixed dose combina antiretrovirals for the treatment of hiv /nr/rdonlyres/ ef e-cf - abb-ab f- adf / / demarzode do human rights matter to health? lancet marde state ( ) texas court of appeal united states academic anti-exclusion arguments. georgetown immigration law journal hivlawandpolicy.org /resources /partial % case % &resource % list-lambda packaged drug products, and single-entity versions of previously approved tarantola d, gruskin s ( ) new guidance on recommended hiv testing and hiv_data/ globalreport/default.asp. accessed the way forward prevention, treatment and human rights consolidated version new law allows needle exchanges in washington modeling health care costs attributable to hiv infection and hiv prevention programs in high-income countries systematic review of abstinence-plus aids epidemic -planning, policy and predictions limited setting: treatment guidelines for a public health approach scaling up antiretroviral therapy in resouurce lawmakers, gay-rights groups protesting new hiv/aids travel unaids/iom ( ) statement on hiv/aids-related travel restrictions international guidelines on hiv/aids and human rights key: cord- -bvalr bl authors: nomura, shuhei; sakamoto, haruka; sugai, maaya kita; nakamura, haruyo; maruyama-sakurai, keiko; lee, sangnim; ishizuka, aya; shibuya, kenji title: tracking japan’s development assistance for health, – date: - - journal: global health doi: . /s - - - sha: doc_id: cord_uid: bvalr bl background: development assistance for health (dah) is one of the most important means for japan to promote diplomacy with developing countries and contribute to the international community. this study, for the first time, estimated the gross disbursement of japan’s dah from to and clarified its flows, including source, aid type, channel, target region, and target health focus area. methods: data on japan tracker, the first data platform of japan’s dah, were used. the dah definition was based on the organisation for economic co-operation and development’s (oecd) sector classification. regarding core funding to non-health-specific multilateral agencies, we estimated dah and its flows based on the oecd methodology for calculating imputed multilateral official development assistance (oda). results: japan’s dah was estimated at . ( ), . ( ), . ( ), . ( ), and . million usd ( ) in constant prices of . multilateral agencies received the largest dah share of . – . % in these periods, followed by bilateral grants ( . – . %) and bilateral loans ( . – . %). ministry of foreign affairs (mofa) was the largest contributors to the dah ( . – . %), followed by ministry of finance (mof) ( . – . %). japan’s dah was most heavily distributed in the african region with . – . % share. the channel through which the most dah went was global fund to fight aids, tuberculosis, and malaria ( . – . %). between and , approximately % was allocated to primary health care and the rest to health system strengthening. conclusions: with many major high-level health related meetings ahead, coming years will play a powerful opportunity to reevaluate dah and shape the future of dah for japan. we hope that the results of this study will enhance the social debate for and contribute to the implementation of japan’s dah with a more efficient and effective strategy. universal health coverage (uhc) is the cornerstone of sustainable and inclusive growth. the promotion of uhc to ensure that all people receive quality health services they need without financial hardship contributes to the development of human resources and security [ ] . at the joint session of finance and health ministers of the group of (g ) held in osaka, japan in june , the "g shared understanding on the importance of uhc financing in developing countries" was confirmed, and agreement was reached to accelerate our global efforts to promote uhc through fair, equitable and preferential use of domestic resources and further invest in primary health care (phc) services [ ] . furthermore, at the seventh tokyo international conference on african development (ticad vii) held in yokohama, japan in august , the yokohama declaration was adopted to promote a robust and sustainable society for human security in africa region, including the achievement of the sustainable development goals (sdgs) and african union (au) agenda as well as uhc [ ] . prioritizing domestic resources and promoting private investment in africa were also agreed as priority areas [ ] . for many donors, development assistance for health (dah) is one of the most important tools for promoting diplomacy and international cooperation with developing countries. for japan, in , the ministry of foreign affairs (mofa) issued the global health diplomacy strategy, officially positioning health as a pillar of government foreign diplomacy [ , ] . as one of the concrete measures, the strategy aims to ensure human security by promoting uhc in developing countries using dah [ ] . human security, as an universal definition, "protects the vital core of all human lives in ways that enhance human freedoms and human fulfillment" [ ] . through its contribution to health, the dah helps build the human capital necessary for economic development [ ] , resulting in greater self-reliance of recipient countries [ ] . also, in an increasingly interconnected world, epidemics, antimicrobial resistance (amr), and other health threats are easily spread, and efforts to prevent or suppress these threats in one country often benefit neighboring and distant countries [ ] . the dah therefore can provide a way for donors and recipient countries to benefit and share global prosperity [ ] . importantly, dah functions as a support for issues that cannot be adequately addressed with domestic and private funds to achieve sdgs, including the sdg target . on uhc. in addition, there is an increasing need to act as a catalyst to strengthen capacity to mobilize and properly manage and disburse domestic and private funds [ ] . dah must also adapt to the growing health effects of climate change, conflict, and refugees/migrants crisis, and global political trends that emphasize national interests [ ] . in early , japanese former foreign minister mr. taro kono (until september ) stated that there was no guarantee that official development assistance (oda) would increase in the future because of japan's fiscal deficit [ ] . as stated in the government official documents and by mr. kono himself, there is a need for more efficient and effective implementation of oda/dah and greater transparency and accountability because oda/ dah is funded by taxes [ , ] . in japan, decision-making and implementation of oda is led by mofa based on the development cooperation charter, reflecting the wishes of other ministries and agencies, such as the ministry of finance (mof) and japan international cooperation agency (jica: an implementation agency that coordinates bilateral oda). in , the oda charter was created by the cabinet office with asia as a priority region, indicating the basic principles of supporting the economic growth and social development of developing countries through oda [ ] . in , it was revised for the second time since the revision in , and the name was changed to "development cooperation charter" [ ] . the core of this revised, new charter is a deep commitment to a proactive contribution to peace standing on the concept of human security [ ] . it also added measures that have not been considered within the framework of oda, such as strengthening cooperation with private sectors; and clarified that oda for military operations must be limited to non-military purposes, such as disaster relief. it puts emphasis not only on the interests of developing countries, but also on securing 'national interests', indicating japan's willingness to actively engage in international cooperation that would contribute to japan's security and economic growth. in the same year, mofa also published the "basic design for peace and health (global health cooperation)" as a guideline for global health policy under the new charter. in this guideline, they put three areas as their priority: promotion of resilient global health governance able to respond to public health crises and natural disasters based on the concept of human security, including the realization of uhc; utilization of japanese expertise, experience, medical products and technologies; and tailored support in response to diversification of regional needs [ ] . in practice, however, due to its complex and fragmented administrative procedures and structures, the actual overall picture and flow of dah has been unclear to date, and strategic decision-making and implementation across ministries and agencies are not sufficient. for example, there is no shared priority among ministries on their own commitments and no inter-ministry collaboration in the budget acquisition process [ ] . jica and other relevant organizations and domestic stakeholders also have their own policies, limiting strategic policy coordination with the government [ ] . here, we present, for the first time, an overview of japan's dah, by examining the tracking of dah using data on japan tracker, the first data platform of japan's dah that the authors were in charge of [ ] . the results of this study will contribute to an effective and strategic dah decision-making and implementation across/within ministries and agencies. data on oda projects from to administered by mofa were used. this data includes, for each project and year, gross disbursements of oda, source (contributing ministry/agency), aid type (bilateral grant, including technical assistance; bilateral loan; earmarked funding to multilaterals [that is also called as 'bi-multi' and was reported as bilateral oda]; and core funding to multilateral agencies [i.e. assessed contributions and non-earmarked funding]), target country/region, and target health focus area. health focus area was based on purpose codes (also known as creditor reporting system [crs] codes) for sector classification defined by organisation for economic co-operation and development's (oecd) development assistance committee (dac) [ ] . purpose codes used for dah were (health) and (population policies/ programs and reproductive health) based on the previous studies, including the five-digit purpose codes [ ] [ ] [ ] . [ ] . regarding core funding to non-health-specific multilateral agencies (e.g., world bank), where it was not possible to directly identify dah out of the oda and its flows to target country/region and health focus area, they were estimated based on the oecd methodology for calculating imputed multilateral oda as follows [ ] . step : based on reports from multilateral agencies to the oecd [ ] , oda flows to the health sector of each agency (i.e., dah) were calculated as a percentage of total oda disbursements (α: health sector share of the agency's total oda). step : based on this report [ ] , each agency's dah flows to each target country/region and each health focus area were calculated (β: target country/region-specific share of the agency's dah, and γ: health focus area-specific share of the agency's dah). step : multiplying α, β, and γ obtained for each multilateral agency by the total oda from japan, we estimated flows of japan's dah through the agency. for example, the mof's multilateral dah through the world bank was estimated by multiplying the total oda from the mof to the world bank by α. in addition, mof's dah through the world bank to a particular target country/region and health focus area was estimated as total oda × α × β and total oda × α × γ, respectively. primary health care and health system strengthening in the spirit of both alma-ata and astana, a wellfunctioning phc system is regarded as the foundation for countries that successfully finance and provide quality health services to their entire population; this is essential to achieve uhc [ , ] . although the current crs system does not facilitate standardized measurement of dah for phc, shaw et al. ( ) attempted to define dah on 'phc delivery' versus on 'health system strengthening (hss)' in support of phc delivery, using crs purpose code data, and our study followed their definition and methodology and estimated how much japan's dah was invested in phc and hss [ ] . in short, as in the previous study, our working definition of phc focused only on inputs that are under the control of the health system itself, so intersectoral interventions (e.g., safe water, sanitation, and hygiene) were not considered. our scope of phc therefore included treatment of diseases and injuries, including the provision of essential medicines; reproductive health; prevention, detection and treatment of hiv/aids, tuberculosis and malaria; public health measures, preventive health care, promotion and education of healthy behavior, good nutrition, and immunization. in this study, we referred to dha for such scope as being most relevant to 'phc delivery'. meanwhile, in order for phc to function properly, system-wide investments are necessary: for example, effective priority setting system; sound management, administrative, financial, and technical capacities; adequate human resources and institution capacity; up-to-date health information systems for monitoring and evaluation of policies and programs; and appropriate regulatory, governance, finance, and accountability mechanisms. in this study, we referred to dah for such investment as being most relevant to 'hss' in support of phc delivery, as in the previous study [ ] . our working definition of hss is therefore much narrower than the extensive discussion of hss often found in the literature, where most public expenditures aimed at improving health care can be interpreted as hss. a discussion of their detailed definition and justification can be found in previous studies [ ] . a list of corresponding crs purpose codes for phc and hss can be found in the resulting table of this study. table . except for in , dah contributed to multilateral agencies had the largest share of about % among all aid types. the share of bilateral (grants) was about % and that of bilateral (loans) was about % in the periods. mofa accounted for majority of the dah contribution ( . %, ), with mof ( . %, ) and ministry of health, labour and welfare (mhlw) ( . %, ) following in that order. japan's dah was most heavily distributed in the african region, with a range of . - . % share between and , followed by south and central asia ( . - . %). figure shows japan's dah by aid type and target region. in bilateral (grants) and multilateral, japan's dah was allocated the most to africa. as for bilateral (loans), the dominant focus was on south and central asia, with the exception of . exact values for fig. table . in japan's dah, health policy and administrative management, medical services, infectious disease control, and sexually transmitted disease (std) control including hiv/aids were the priority areas, which occupied a share over about % every year. however, by aid type the trend was different (fig. ). infectious disease control had largest shares in bilateral (loans) except for - , while std control including hiv/aids had the largest share in multilateral. for bilateral (grants), on the other hand, japanese funds also focused around basic health infrastructure and health policy and administrative management. basic nutrition demonstrated a steep decline in its share in - among the bilateral grants. it was . % in , but fell to . % in . exact values for fig. can be found in supplementary table . to quantify levels and trends in dah to phc and hss, the five-digit purpose codes were grouped into two broad clusters (phc and hss). as reported in fig. with exact values presented in supplementary this study provided, for the first time, an estimated gross disbursement of japan's dah and its flows. japan's dah was found to be approximately million usd in . the main source of dah was mofa. according to the oecd statistics, japan's gross disbursements of oda in amounted to . billion usd [ ] , which means that the share of dah in oda was about . %. in accordance with the oda charter, japan has traditionally placed asia, which has a close relationship with japan, as a priority region [ ] . meanwhile, we revealed that approximately half of japan's bilateral and multilateral dah were allocated to the african region in the study periods (fig. ) . this finding may reflect japan's recent efforts to strengthen its diplomatic relations with african countries through various efforts including ticad as well as agenda and sdgs. for example, japan hosted ticad vi in kenya in and launched the "uhc in africa: framework for action" in partnership with the world bank, who, the global fund, and the african development bank [ ] . this is a roadmap for african countries to accelerate progress towards uhc and to monitor and assess their progress. in the same year, japan hosted the ise-shima group of seven (g ) summit, which was held in the aftermath of the ebola crisis in western africa, providing an important opportunity for japan to advance global health governance issues [ ] . in addition, in may , jica signed, for the first time, an oda loan agreement of up to . million usd (at current price in ) with the government of the federal republic of nigeria for the polio eradication project [ ] . this project aimed to contribute to the early eradication of polio in nigeria by ensuring smooth vaccination of children under five years of age throughout the country through the procurement of polio vaccines. oda loans to africa in in fig. refer to this project. this study examined the distribution of earmarked funding (bi-multi) and core funding to multilateral agencies for dah in - . bi-multi funding is a resource to multilateral agencies over which the donor retains some degree of control on decisions regarding disposal of the funds. such flows may be earmarked for a specific country, project, region, sector or theme. it is aid for bilateral functions channelled through on the other hand, core funding to multilateral agencies are used for a variety of purposes, some of which are channeled to global functions (e.g., provision of global public goods, management of cross-border externalities, and fostering of leadership and stewardship). schäferhoff et al. ( ) estimated the total share of core funding going to global functions by agencies, as follows: who %, unaids %, unfpa %, unicef %, world bank (international development association) %, global fund %, and gavi % [ ] . in japan, core funding accounted for the majority of the dah channeled through multilateral agencies, except for those through unicef and unfpa. in particular, japan's core funding to who, which primarily focuses on global functions, has ranked nd in the world after the united states [ ] . it may be said that japan's global functions in relation to the global trends is relatively high. this finding may be consistent with the direction of the basic design for peace and health, which emphasizes the strengthening of global functions based on the concept of human security. for example, at the ise-shima g summit, japan emphasized the promotion of aid for global functions both in the g ise-shima leaders' declaration and g ise-shima vision for global health [ , ] . while the effective dah allocation has long been discussed, it might be guided by a number of factors, including historical and traditional diplomatic relations, geographic proximity, strategic reciprocity, and trade-related considerations, particularly in bilateral aid; and not necessarily aligned with disease priorities for health aid in recipient countries and cost-effectiveness of interventions [ ] . globally, however, dah growth has been stagnant over the past years and limited financial resources are a universal constraint [ ] ; japan is not exception. it is, therefore, an urgent policy issue to implement dah strategies wisely, efficiently and effectively, while ensuring transparency. both in the global health diplomacy strategy and the basic design for peace and health, protecting human security has been a core concept of japanese foreign policy [ , ] . human security is at a convergence that combines the competing policy issues that could threaten vital core of all human lives, including infectious disease epidemics (as exemplified by the recent ebola outbreak [ ] or pandemic influenza) as well as refugee and migration crises and climate change. human security approach thus enriches the synergy between measures to address these issues. for example, among the nearly one million rohingyas, an islamic minority group, living in a refugee camp in bangladesh, there is a growing concern about a serious infectious disease epidemic, including measles, cholera, and typhoid [ ] . also, as global warming progresses, the distribution of vectors such as mosquitoes that transmit japanese encephalitis, dengue fever, malaria, and yellow fever, may expand [ , ] . human security approach will also contribute to the achievement of sdgs as well as au agenda by building a healthy, sustainable, and stable society. an important issue in the dah strategy for donors is therefore to consider how donors should fund their human security efforts from a limited oda budget, and in particular what is the optimal role of dah in this context. for example, japan is one of the founding partners of the global fund and a major donor who contributed . - . % of dah to the global fund in - . since its establishment in , an accumulated . billion usd has been contributed from japan [ ] . at the meeting of the sustainable development goals promotion headquarters on june , prime minister shinzo abe announced japan's new pledge of million usd to the global fund's sixth replenishment [ ] . infectious disease control is an important dah strategy of japan, which covered . - . % of japan's dah shares overall between and , and was mostly channeled through the global fund. in the context of human security approach to climate change and refugees and migrants crisis, further scale-up of dah investments in effective infectious disease control is expected. note that human security approach in this context means supporting people-centered, comprehensive, context-specific, and prevention-oriented responses that strengthen the protection and empowerment of all people, adopting partnerships across sectors, developing context-sensitive solutions, and supporting the realization of a world without fear, want, and dignity [ ] . caution is needed that while human security as a rationale for linking foreign policy and health introduces significant political power, sufficient attention must be paid to the possibility that national security interests may be skewed towards health and humanitarian issues [ ] . it should also be noted that treating global health issues as national security threats, rather than universal issues to be concerned with the humanity, may cause an excessive concern surrounding diseases surveillance and a divide between affected countries and non-affected countries. in the past, for example, securitization was misused as a rationale for implementing hiv-based travel, migration, and immigration control policies and laws prohibiting the entry of people living with hiv [ ] . the results also showed that between and , approximately % of dah were allocated to phc, and remaining % to hss. although there are no established norms or benchmarks on the balance between phc and hss allocations in dah, the high level task force on innovative international financing for health systems (hltf) proposed that approximately - % of the additional resources would be required for hss-that are broadly consistent with the above definitions-in order to achieve the millennium development goals (mdgs) for low-income countries [ ] . in terms of the mdgs, therefore, the balance between phc and hss in japan's dah could be roughly reasonable. however, in today's era of sdgs, the growing emphasis on social determinants of health makes it even more crucial that dah strengthens health system, including institutional capacity (effectiveness of surveillance systems and laboratory networks, etc.), administrative and financial systems, and human resources development [ ] . donor-recipient countries face the challenges posed by health transition, i.e., a double burden of morbidity, mortality, and associated health care costs from increasing non-communicable diseases (ncds) and continuing high communicable diseases [ ] . phc has played a successful role in the delivery of prevention and care interventions for communicable diseases, such as malaria, tuberculosis, and hiv/aids. however, it is imperative to expand the delivery of phc in countries undergoing health transition in terms of health promotion and disease prevention and treatment in response to ncds [ ] . with limited resources, several studies suggested the need to take a diagonal approach of hss to address ncds, rather than disease-specific, vertical programs [ , ] . hss has the potential to improve the delivery of phc in a cost-effective manner by dealing with the wide range of health problems encountered in health transition. hss are emerging important focus of some multilateral agencies, such as the world bank and the global fund (japan's major dah channels), as well as the gavi, the vaccine alliance. there is an increasing debate as to why donor countries, including japan, should invest more in ncds [ ] . a study demonstrated that recently only % or less of japan's dah went to ncds [ ] , whereas ncds accounted for - % of total disease burden in lowand lower-middle-income countries (lmics) [ ] . however, this does not imply that funds for infectious disease control should be used to scale-up to confront ncds through hss. between and , . - . % of japan's dah went to infectious diseases control including hiv/aids, which has aligned with disease burden in lmics to some extent (or lower), where infectious disease accounted for about - % of the total disease burden in lmics [ ] . importantly, japan's dah allocation should take full account of the health transition of dah-recipient countries and make the burden of disease an important criterion for prioritizing resource allocation [ ] . in the future, it will become increasingly important to promote prevention as well as treatment by focusing on hss in recipient countries. more effective health spending is needed in developing countries, and they should use all available resources. recognizing this need, sdg aims to strengthen domestic resource mobilization and improve domestic fiscal capacity for tax and other revenue collection [ ] . in addition, under the addis ababa action agenda, countries pledged to achieve the sdgs, largely using domestic resources [ ] . these are also recognized as common understanding to achieve uhc at the joint session of finance and health ministers at the osaka g summit this year as well as at tivad vii [ , ] . on the other hand, a recent study estimated that achieving uhc would require an increase in annual per capita health spending of more than usd by in lmics [ ] . more spending may be needed, especially as the country develops economically and prices rise. this figure is much larger than dah alone can cover. while taking into account the country's own priorities, it is the most important strategic challenge for donors to consider how dah can support the use and mobilization of domestic resources and how it can intervene in ways that reduce investment risks for the private sector [ ] . for multilateral aid, the global financing facility (gff) and global action plan for healthy lives and well-being for all is a new approach that leverages domestic resources as well as ongoing funding from private and public sources. japan is one of the donor countries of gff as of may . the first commitment, a pledge of million usd, to the gff by the government of japan was announced at the uhc forum [ ] . in addition, donors should be aware of the potential for the implementation of dah to impair the ability of dah-recipient countries to properly plan health budget disbursements, and should seek ways to avoid it. a study by the world bank and other institutions found that the costs of using parallel systems of dah and domestic resources were more than four times higher than relying solely on national financial systems and skills transfer [ ] . also, there is an evidence of negative correlation between dah and domestic resources; dah may constrain the domestic health budget and cause its significant portion substituted out of the health sector [ , ] . decision-making and implementation of dah should consider how financial flows in dah-recipient countries interact with each other. while oda system is well-known, many complexities are involved in its use. this study made use of dah on gross disbursements rather than commitments as disbursements are actual distributions of committed aid funds, while the commitments are amount the donor agreed to make available to. in some cases, disbursements could be more volatile than commitments, conditional on specific country events (e.g., political instability), and absorptive capacity during any one year [ ] . as noted in the previous study [ ] , it is difficult to draw a strong conclusion about the share of phc and hss for several reasons. first, there is a lack of global agreement on measurable indications for phc and hss. it also includes the lack of normative descriptions of the share of dah by donors for phc and hss. the method developed in the previous study (and used in this study) can be reproduced using oecd/crs data and may serve as a useful method to track future donor resources allocated to phc/hss. our estimates of dah are not necessarily comparable to those of the institute for health metrics and evaluation (ihme) at the university of washington, which also provides an alternative source of data on dah [ ] . ihme uses rather complicated mathematical procedures to classify aid based on a 'word search' of project/program content, rather than the long-established coding procedures followed by donors for the oecd/crs data base. ihme estimates tend to be relatively large in value than our estimates based on the oecd coding procedures. for example, in japan, a dah of was estimated to be million usd in this study, while ihme estimates was million usd (at constant price in ) [ ] . this may be because the ihme's estimation method using word search allows some consideration even in areas, such as 'agriculture' (crs code ), 'water and sanitation' ( ), and 'education' ( ) that the oecd coding procedures based on the crs code does not consider as 'health' ( + ). in addition, in the oecd coding, there are focus areas in the field of health, while ihme classifies health into focus areas. ihme also provides very important data, although the methods of estimation and classification are different. however, this study adopted the oecd coding procedures, whose categorization is more familiar and straightforward for policy makers and government officials in japan to understand. this study used only data from japan over a five-year period, and therefore does not provide long-term trends of dah or comparisons with other countries, or any consideration from the perspective of japan's relative position in global health diplomacy. this is our next research scope. with many major high-level health related meetings ahead, coming years will play a powerful role in reevaluating dah and shaping the future of dah for the world and japan. we hope that the results of this study, which provide an overview of dah in japan, will enhance the social debate for and contribute to the implementation of japan's dah in a more efficient and effective strategy. additional file : figure s . developing assistance for health channeled through multilateral agencies unicef: united nations children's fund; undp: united nations development programme; afdb: african development bank; asdb: asian development bank; iadb: inter-american development bank; global fund: the global fund to fight aids, tuberculosis and malaria; gavi: gavi, the vaccine alliance who: world health organization; unaids: joint united nations programme on hiv/aids; unfpa: united nations population fund; unicef: united nations children's fund; undp: united nations development programme; afdb: african development bank; asdb: asian development bank; iadb: inter-american development bank; global fund: the global fund to fight aids, tuberculosis and malaria; gavi: gavi, the vaccine alliance; jica: japan international cooperation agency. other un agencies include food and agriculture organization (fao), united nations relief and works agency for palestine refugees in the near east (unrwa), world food programme (wfp), etc. ngos include international planned parenthood federation, etc. others include global environment facility (gef), etc. table s . developing assistance for health channeled through multilateral agencies usd in million, %): (a) bilateral (loans), (b) bilateral (grants), (c) multilateral, (d) total. std: sexually transmitted disease. crs purpose code: basic health care = ; basic health infrastructure = ; basic nutrition = ; health education = ; health personnel development = malaria control = ; tuberculosis control = ; std control including hiv/aids = ; health policy and administrative management = ; medical education/training = usd in million, %): (a) bilateral (loans), (b) bilateral (grants), (c) multilateral, (d) total. phc: public health care; hss: health system strengthening. phc definition # = basic health care and infrastructure (crs purpose codes: , , , , ); phc definition # = reproductive health care and family planning ( , ); phc definition # = infectious disease control, including malaria and tuberculosis broader phc definition = definition # + # + # + # ; hss definition # = health policy, administration & management ( ); hss definition # = medical services hss definition # = population policy & administration abbreviations amr: antimicrobial resistance; au: african union; crs: creditor reporting system; dac: development assistance committee; dah: development assistance for health tuberculosis and malaria; hss: health system strengthening; ihme: institute for health metrics and evaluation; jica: japan international cooperation agency; lmics: low-and lower-middle-income countries; maff: ministry of agriculture, forestry and fisheries; meti: ministry of economy, trade and industry; mhlw: ministry of health, labour and welfare; mof: ministry of finance; mofa: ministry of foreign affairs; ncds: non-communicable diseases; oda: official development assistance sustainable development goals; std: sexually transmitted disease ticad: tokyo international conference on african development uhc: universal health coverage; who: world health organization references human security and universal health insurance tokyo: ministry of foreign affairs ministry of foreign affairs. yokohama declaration -advancing africa's development through people, technology and innovation. tokyo: ministry of foreign affairs japan's strategy for global health diplomacy: why it matters japan's 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affairs taro kono at keio university "mr. taro kono talks on oda tokyo: ministry of foreign affairs japan's official development assistance charter. tokyo: ministry of foreign affairs ministry of foreign affairs. cabinet decision on the development cooperation charter. tokyo: ministry of foreign affairs basic design for peace and health (global health cooperation). tokyo: ministry of foreign affairs japan's global health policy: challenges and challenges tokyo: institute for global health policy research organisation for economic cooperation and development how much donor financing for health is channelled to global versus country-specific aid functions? does donor proliferation in development aid for health affect health service delivery and population health? cross-country regression analysis from to countdown to : tracking donor assistance to maternal, newborn, and child health geobook: deflators: oecd oecd methodology for calculating imputed multilateral oda oecd international development statistics. paris: organisation for economic cooperation and development world health organization. declaration of alma-ata. geneva: world health organization world health organization. declaration of astana. geneva: world health organization donor and domestic financing of primary health care in low income countries universal health coverage (uhc) in africa: a framework for action protecting human security: proposals for the g ise-shima summit in japan signing of japanese oda loan agreement with the federal republic of nigeria assessed contributions by member states and associate members, showing a % increase in total assessed contribution financing for tokyo: ministry of foreign affairs g ise-shima vision for global health. tokyo: ministry of foreign affairs bilateral donors' interest vs. recipients' development motives in aid allocation: do all donors behave the same? global burden of disease health financing collaborator, network. past, present, and future of global health financing: a review of development assistance, government, out-of-pocket, and other private spending on health for countries health risks of rohingya refugee population in bangladesh: a call for global attention the impact of climate on japanese encephalitis global climate change and its potential impact on disease transmission by salinity-tolerant mosquito vectors in coastal zones the global fund. government donors -japan. geneva: the global fund global fund welcomes japan's commitment to save one million lives. geneva: the global fund resolution adopted by the general assembly global health and national security: the need for critical engagement knippenberg, r. health systems for the millennium development goals: country needs and funding gaps -background document for the taskforce on innovative international financing for health systems. working group : constraints to scaling up and costs addressing the social determinants of health through health system strengthening and intersectoral convergence: the case of the indian national rural health mission measuring progress from to and projecting attainment to of the health-related sustainable development goals for countries and territories: a systematic analysis for the global burden of disease study health transition in africa: practical policy proposals for primary care. b world health organ the 'diagonal' approach to global fund financing: a cure for the broader malaise of health systems? an assessment of interactions between global health initiatives and country health systems council on foreign relations. the emerging global health crisis: noncommunicable diseases in low-and middle-income countries. new york: council on foreign relations global, regional, and national disability-adjusted life-years (dalys) for diseases and injuries and healthy life expectancy (hale) for countries and territories, - : a systematic analysis for the global burden of disease study sustainable development goal resolution adopted by the general assembly on beating the drum in lower-income countries. oslo: global financing facility government of japan to invest us$ million in global financing facility to accelerate progress on universal health coverage understanding the costs and benefits of unharmonized and unaligned fm arrangements: pfm in health sector public financing of health in developing countries: a cross-national systematic analysis measuring the displacement and replacement of government health expenditure a review of health resource tracking in developing countries publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we would like to express our gratitude to the staff of each ministry and agency who contributed to the data provision and coordination for the data analysis of japan tracker that the authors were in charge of. our estimates of dah were partially reported at japan tracker on august (https://japantracker.org/en/). japan tracker is the first data platform in japan to visualize the flows of japan's dah, launched in november under the industryacademia-government collaboration and support by the bill & melinda gates foundation. not applicable. all authors conceived of and designed the study and take responsibility for the integrity of the obtained data and accuracy of the data analysis. sn, hs, ms, hn, ks, sl, and ks acquired the data. sn and hs analyzed and interpreted the data. sn drafted the article. all authors made critical revisions to the manuscript for essential intellectual content and gave their final approval. this work was primarily funded by the bill & melinda gates foundation. the funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. the views expressed in this paper are solely those of the authors. all data generated or analysed during this study are included in this published article and its supplementary information files.ethics approval and consent to participate not applicable. the authors declare that they have no competing interests. key: cord- -lt is is authors: preston, nicholas d.; daszak, peter; colwell, rita r. title: the human environment interface: applying ecosystem concepts to health date: - - journal: one health: the human-animal-environment interfaces in emerging infectious diseases doi: . / _ _ sha: doc_id: cord_uid: lt is is one health approaches have tended to focus on closer collaboration among veterinarians and medical professionals, but remain unclear about how ecological approaches could be applied or how they might benefit public health and disease control. in this chapter, we review ecological concepts, and discuss their relevance to health, with an emphasis on emerging infectious diseases (eids). despite the fact that most eids originate in wildlife, few studies account for the population, community, or ecosystem ecology of the host, reservoir, or vector. the dimensions of ecological approaches to public health that we propose in this chapter are, in essence, networks of population dynamics, community structure, and ecosystem matrices incorporating concepts of complexity, resilience, and biogeochemical processes. definitions of one health have varied among different authors and institutions, but a defining central tenet is that a one health approach brings a holistic understanding of health. this broader view includes human medicine, veterinary medicine, and an understanding of the ecological context of health (which we call 'ecohealth'). to date, one health approaches have tended to focus on closer collaboration among veterinarians and medical professionals, but remain unclear about how ecological approaches could be applied or how they might benefit public health and disease control. in this chapter, we review ecological concepts, and discuss their relevance to health, with an emphasis on infectious diseases, notably emerging infectious diseases (eids). nearly two-thirds of eids are zoonotic, and a majority of those ( %) originate in wildlife (anderson et al. ; cleaveland et al. ; daszak ) . diseases are considered 'emerging' if they are identified as occurring in a new geographic area, expanding their incidence rapidly, displaying novel genetic code, or moving into humans for the first time. the most important are pandemics, those that become established in humans and spread internationally. pandemics tend to be zoonotic, foodborne, or antimicrobial resistant pathogens, and their emergence and spread is overwhelmingly a result of changes in human demography (e.g. travel, population growth), behavior (e.g. drug use), economic activity (e.g. agricultural intensification), or anthropogenic changes to the environment (e.g. land-use change, climate change) (weiss and mcmichael ; jones et al. ) . the interactions among these underlying drivers and the dynamics of pathogens in wildlife, livestock, and people are a key focus of studies of the ecology of infectious diseases. ecology emerged from natural history and rose to prominence as a scientific discipline in the late nineteenth century as the 'study of the interactions of organisms with their environment' (haeckel ) . while originally a descriptive science, the theories of adaptation, evolution, and speciation rapidly became central to the field, and led to increasingly analytical approaches (lawton ) . over the past few decades, ecologists have analyzed data from field observations, laboratory studies, and large-scale field experiments to describe the structure and dynamics of populations, their interactions within communities, and the complexity of ecosystems. in this chapter, we build on the work of wilcox and jessop ( ) and last ( ) , adding an ecosystem network perspective to describe how ecological approaches can be focused on infectious diseases. we focus on three components: population, community, and ecosystem ecology. population ecology is the study of the population dynamics of a species with relevant metrics of density, natality, mortality, immigration, and emigration (hall ; murray ) . population dynamics are generated through competition, predation, parasitism, and the distribution of species. community ecology describes the clustering of populations of species into communities and the processes that dictate composition and diversity. pertinent community metrics are similarity, continuity, species, and genetic diversity. ecosystem ecology is the study of biotic and abiotic components of ecological systems, their biophysical interactions, and the flow of energy and materials (lindeman ; odum ; cook ) . the metrics for ecosystems include state, rates, and productivity. ecosystems provide the framework for organization of species and resource compartments, and modulate rates and dynamics of functions, processes, and services. in modern ecological approaches, a network perspective can be used to describe interactions among ecosystem components, with populations referred to as nodes, links between nodes in a community as edges, and the overall environment and abiotic components as an ecosystem matrix (fig. ) . this framework complements a shift in ecosystem thinking from structures and hierarchies, to networks and webs. while the concepts in this chapter are presented in the context of wildlife and emerging infectious diseases, they are generalizable to diverse ecosystem interactions. traditional views of ecosystems were focused on the concept of directional succession, whereby ecosystems developed along a predictable pathway to a climax system (e.g. mature deciduous forest) (clements ; gleason ) . in reality, ecosystems are dynamic and complex aggregations of communities continually adapting to internal and external influences. rarely are they stable or at fig. diagram illustrating the ecosystem components described in the text: a node is a population of organisms; edges are links between nodes in a community; and the overall environment including abiotic components is the ecosystem matrix. nodes are structured vertically into trophic levels and horizontally along an environmental gradient equilibrium, as described by static representations of food chains, trophic guilds, and species dominance. moreover, they demonstrate non-equilibrium dynamics in a mosaic of patches shifting among stable states when disturbed. the complex structure of ecosystems has long frustrated efforts to forecast and predict their behavior, yielding models of resilience, complexity, and chaos. ecosystems: abundance, structure, and flow historically, public health has focused on the dynamics and structure of human populations-only a single node within the context of global ecosystems. holistically, human health can best be considered in the context of other organisms within a network of populations, communities, and ecosystem interactions. infectious diseases within a one health context require an additional dimension, namely the natural environment as the habitat of the disease agents themselves, examples of which include water borne diseases. population ecology focuses on the dynamics of an individual species in a defined area, where the malthusian growth model is a central theory. however, wildlife populations are not static, nor is their growth linear. moreover, they display complex cycles and populations evolve from interactions, including competition, predation, herbivory, and mutualism, while demonstrating stochastic dynamics and lagged responses to disturbance. because knowledge of wildlife populations still is incomplete, there are many species for which historic data are lacking or routine monitoring not yet possible. furthermore, coverage varies across geographic regions, taxonomic groups, size, abundance, and economic or social values. despite the fact that most eids originate in wildlife, few studies account for the population dynamics of the host, reservoir, or vector, in contrast to studies of human populations and demographics. this uncertainty concerning wildlife health presents a threat both to domestic animals and human populations. at a minimum, those infectious disease agents closely linked to human health should be identified and subjected to intense study, e.g., those that incubate and spread disease or provide ecological services such as disease regulation and/or vaccine discovery. identifying these key species helps set priorities for routine surveillance, as well as uncovering as yet unknown species that present a threat or cure. fluctuations in host and vector abundance engender a variable risk distribution for disease transmission. some species are unique in their proximity to human physiology (e.g. primates and wild pigs) or in their expansive ranges (e.g. birds and bats), posing unique threat as integrators, spreaders, and laboratories for recombination and mutation of disease pathogens (daszak ) . wildlife population ecology can be employed to improve global health models, but within limitation. populations are difficult to define and species-based definitions are generally inadequate. those that are naturally or artificially isolated often exhibit distinct behaviors and present differential risks (levins ). populations are a continuum, where factors such as age, sex, and size can influence risk of disease transmission, especially where distribution of the agent is not uniform. thus, it is simplistic at best to consider population dynamics in isolation from the community structure and ecosystem matrix. community ecology describes an assemblage of nodes and their interactions, or edges. the contributions of individual populations can be characterized by employing network metrics, an example of which would be a high degree of connectivity that identifies critical, keystone nodes influencing the structure of the system. it should be noted that communities can demonstrate both equilibrium and non-equilibrium dynamics. characterizing biodiversity is fundamental to community ecology. it is also one of the more widely reported and popular concepts. biodiversity varies across spatial scales and describes both intraspecific or genetic diversity of a node, as well as diversity of nodes described in terms of richness, abundance, and evenness (bisby ; jost ; whittaker ) . food webs represent a central concept in ecology, being employed to model community structure as complex hierarchies of nodes (lindeman ; elton ; forbes ; hairston et al. ). inter-node interactions (edges) among consumers and resources form the backbone of food-web networks and the nodes can be structured into trophic levels, or functional groups, such as top predators (borrvall and ebenman ; finke and denno ) , mesopredators (elmhagen and rushton ), herbivores, and primary producers. edges are generally unidirectional, but can flip during the life history of an organism when lower trophic levels prey on juveniles of higher trophic levels. single trophic food webs are the simplest (tilman ), but few real-world examples exhibit those dynamics, with multi-trophic perspectives more realistic, albeit complex (cohen ; deangelis ; polis and winemiller ) . predator-prey relationships are dominant in representations of the structure of trophic hierarchies, along with the influences of co-evolution, mutualism, autotrophy, herbivory, competition, genetics, and speciation. food webs are structured from top and bottom. top-down control of food webs can occur via predation and resource consumption by consumers, influencing community size structure. at the same time, bottom-up mechanisms operate via abundance, availability, and edibility of primary producers (autotrophs) and secondary producers (herbivores). structural dynamics of a system, i.e., arrangement of nodes and edges, can influence the magnitude and variability of community response to disturbance. endogenous (internal) pressure from one node can reorganize the entire system. food webs are often portrayed with linear connections among trophic levels; however, responses to exogenous (external) disturbance can expose complex nonlinear dynamics and feedback loops. unlike characterizations such as a balance of nature or tree of life, it is apparent from food-web manipulations that ecological networks are complex systems encompassing hierarchies, webs, nested systems, cycles, and flows (carpenter and kitchell ; scheffer and carpenter ) . when ecology is incorporated into public health endeavors, the scope is frequently limited to distribution and abundance of individual nodes. studying the population dynamics of disease hosts and vectors clearly is important if zoonotic disease emergence is to be understood, but populations need to be studied in the context of edges defining their interactions with other nodes. indeed, a community approach to disease emergence can reveal important nodes and interactions that differ from those identified in population analyses. for example, some nodes, such as keystone species, may be disproportionally important to the system due to strong connectivity or high centrality. superspreaders are highly connected and rapidly disseminate disease through a network. identifying and monitoring the keystone species, superspreaders, and nodes that regulate host and vector abundance is important in disease prevention and control. trophic cascades regulate host abundance when changes at one trophic level cascade through the food web. for example, when a predator population collapses, regulation of the disease is reduced if the disease host or vector is thereby released from control by predation. removing predators directly relieves pressure on prey abundance and may also alter physiological stress, behavior (bakker et al. ) , and morphology (werner and peacor ) of their prey. clearly, both host and predator require monitoring in such circumstances. inter-species competition affects abundance, evolution, diversity, and pathogenicity of a disease agent. these processes can be tightly coupled to their pathogen hosts and, in turn, the community dynamics of the system. hence, the invasion of an exotic species, triggered by wildlife trade, transportation, or climate change for example, could cause food webs to reorganize thereby altering the probability of disease emergence. on one hand, the introduction of a species like the tiger mosquito (aedes albopictus), which is an aggressive disease vector, can alter the conditional (binary) probability of contracting certain vector-borne diseases. on the other hand, invasions by suboptimal hosts can 'dilute' disease risk. invasions can also introduce boom and bust dynamics, destabilizing systems and tipping native populations into irreversible alternate states. invasive species also diverge genetically from their original populations through isolation and founder effects, contributing to ''waves'' of disease occurrence. spatiotemporal variance in food webs is particularly acute for migratory populations, where resource consumption changes with habitat and the effect on nodes in one system can be transferred to another. in effect, migration provides a unique opportunity for populations and communities to exchange pathogens. in these scenarios, mapping distributed food webs could help identify pathways for disease transmission. food web and community network analyses introduce a high degree of complexity to mathematical and statistical models of systems. furthermore, it is difficult to determine accurately the trophic position of individual nodes in food web models. while advances in stable isotope analysis, fatty acids, and ecological stoichiometry help determine trophic position relative to other nodes in the community, as well as composition of diet; isotopic measurements often have location-specific limitations, whereby values are relative to local autotrophic production in the system as influenced by external subsidies. thus, it is difficult to draw meaningful comparisons among food webs. what is required is a method that generalizes models and captures topological position and functional importance of networks without a food web-specific bias (olff et al. ). by using food-web manipulations, it has been possible to demonstrate biogeochemical processes play an important role in structuring communities (carpenter and kitchell ; scheffer and carpenter ) . so, although community ecology considers both nodes and the edges that connect them, these systems must ultimately be studied in the context of their environment or ecosystem matrix. ecosystem ecology encompasses biophysical mechanisms regulating ecosystem metabolism across both biotic and abiotic compartments, this includes ecological function, physiological processes, populations and communities, resource availability, nutrient cycling, and connections among systems. the connections, flows, and cycles affecting the life history of an organism are highlighted, including materials of composition and their life cycle. traversing networks that incorporate abiotic pathways may help map these connections, a useful example of which is the carbon cycle, with biotic and abiotic compartments through which carbon can flow, sequester, or transform. the ecosystem matrix is a spatiotemporal mosaic that provides background structure for ecosystem networks. it is a complex system with unpredictable dynamics, including bidirectional relationships among organisms that extract, modify, and release resources into their surroundings. the physical-chemical conditions that surround an organism regulate metabolism as they consume resources and generate waste (begon et al. ) . ultimately, resource flows influence system dynamics of populations and communities. biogeochemistry describes the flow of matter, such as nutrients and toxins, through an ecosystem matrix, including processes such as decomposition and decay. it spans biotic and abiotic compartments through biologically mediated chemical cycling of nutrients. microorganisms play a critical role in the availability of resources by decomposing waste and processing mineral components, essentially driving nutrient cycles in ecosystems. temperature, salinity, ph, and redox generate gradients regulating distribution of organisms and their metabolism, in effect the availability of resources (schlesinger ) . availability of resources, notably nutrients, is related to population dynamics, e.g., the life cycle of organisms, and community structure, such as food webs. phosphorus, for example, is a commonly limiting nutrient in freshwater lakes that constrains productivity. while phosphorus can be introduced through external subsidies, the ecological community can influence availability of the resource internally, thereby altering community composition. certain zooplankton, for example, sequester phosphorous for their reproductive needs to the extent that they limit growth and abundance of competing species. these competitive interactions will ultimately affect water quality and physical characteristics, such as transparency and temperature profiles (elser et al. ) . physical-chemical conditions of the matrix drive enzymatic processes and affect habitat suitability and niche structure in ecosystems. olff et al. ( ) proposed an additional horizontal ecological-stoichiometry axis to supplement the vertical trophic axis in food webs (fig. ) . these frameworks build upon research in marine systems (azam et al. ) and terrestrial systems (bardgett ; wardle ) that emphasize a 'dual foundation' for food webs based on both organotrophs and autotrophs. the landscape provides the physical structure for the ecosystem matrix, including habitat niches for organisms. physical connectivity (e.g., wildlife corridors) can dictate the distribution and dispersal of organisms. as chemicals transition among media such as water, the atmosphere, and land they are modified in ways that alter their availability. landscapes support a mosaic of abiotic conditions that determine the phase space of abiotic resources, including chemical state and suitability for uptake. ecosystem engineering is the process whereby organisms influence the biophysical feedback mechanisms that structure their habitat. this can fundamentally alter ecosystem function from local to global scales (e.g., beaver dams to forest respiration). ecosystem engineers influence the matrix in which they live, rendering it more or less habitable for themselves and their competitors (jones et al. ; wright and jones ) . in australia, for example, a rabbit fence was built to confine expansion of invasive rabbits, altering patterns of herbivory that, in turn, affected evapotranspiration and regional precipitation. ultimately, this altered the microclimate and suitability of the environment for multiple organisms and processes (lyons et al. ) . feedback loops and cycles add complexity and nonlinearity to the system. they can lead to emergence of alternate stable states, with abrupt tipping points, where shifts to alternate regimes modify function and introduce chaos (scheffer and carpenter ; carpenter et al. ; huisman and weissing ; van de koppel et al. rietkerk ). ecosystem processes influence human health directly via interaction with toxins and nutrients, and indirectly via regulation of disease cycles and intensity. bioaccumulation of toxins throughout food webs poses a health threat, an example of which is dichlorodiphenyltrichloroethane (ddt), effective in controlling disease vectors but endangering animal and human health by its bioconcentration. ecosystems provide services such as sequestering toxins in wetlands and sediments, but these processes often are fragile and their disruption results in system-wide impacts. nutrient enrichment, or eutrophication, of lakes has been directly correlated with prevalence of aquatic disease agents (johnson and carpenter ) . regulation of disease is an indirect ecosystem service. however, perturbations of ecological systems can alter the regulatory process and unleash novel pathogens, demonstrated vividly by lyme disease and the dilution effect (ostfeld and keesing ) . in today's world, the biosphere is undergoing unprecedented anthropogenic ecosystem engineering, ranging from land conversion to ecological simplification and extensive biogeochemical change. the impact of these alterations spans ecosystem nodes, edges, and pathways with profound ramifications for ecosystem services and resilience. as the modified ecosystems and regimes emerge, their potential to impact human health must be understood. investigators have developed hotspot maps to characterize risk of disease emergence (jones et al. ) and threats to biodiversity (mittermeier et al. ). however, coupled socio-ecological models of risk have yet to be developed. as a network evolves, dynamic risk mandates continuous adaptive iterations to monitor emerging threats. the major drivers are direct anthropogenic land-use change, e.g., deforestation, agricultural expansion, habitat destruction, and complex indirect feedback from anthropogenic impact affecting biogeochemical cycles, e.g., nutrient cycles and climate change. the phase space for ecosystems evolves as communities are restructured. emerging systems are unstable and exhibit complex non-equilibrium dynamics and alternate states. getting ahead of an epidemic curve (fig. ) requires more than simply aggregating concepts of populations, communities, or ecosystems (schoener ). the changing network properties of the system must be monitored, along with indicators of resilience and leading indicators of collapse, if how a major disturbance is propagated or dampened through the system is to be understood. failing to comprehend the emerging topology of coupled socio-ecological systems presents a challenge of knightian uncertainty, where risk is immeasurable, and panarchy, where cause and effect are disproportionate. in these instances, disturbances can become amplified through emerging network dynamics. changes like habitat destruction and land-use/land-cover change affect the physical structure of the environmental matrix and have profound impacts on ecosystems. they jeopardize critical services, e.g., disease regulation and other, as yet unknown, ecosystem services. for example, minor disturbances from deforestation in the peruvian amazon exposed frontier effects, whereby cases of infectious disease peaked with human encroachment, but re-stabilized as humans and pathogens adapted (olson ) . it is difficult to anticipate consequences of ecosystem encroachment since the dynamics are highly variable and outcomes unpredictable. however, in this case the system exhibited altered contact and transmission rates, as well as improved habitat for malaria vectors. genetic diversity dictates adaptability. we should anticipate widespread physiological, morphological, and behavioral adaptations with land-use change, and inevitable consequences for disease emergence. geography and landscapes have long been known to play a critical role in disease, indeed the earliest disease maps by finke and humboldt date from the early victorian period (tylianakis et al. ). hence, we can anticipate that landscape changes will fundamentally alter existing ecosystem networks. changes at the landscape level, such as isolation due to habitat fragmentation, counter the trend of more highly connected systems. however, an increase in isolated systems may lead to increased genetic drift and introduce new vulnerabilities from founder effects and genetic bottlenecks. these refugia and biological corridors become hotspots for disease transmission as organisms are crowded out of the human landscape and stressed by reduced resource availability. the green revolution brought widespread alterations to global biogeochemistry. accompanying changes in agricultural practice altered the agrarian landscape-an important habitat in terms of both surface area and productivity. in this context, biogeochemistry is particularly relevant to health, given anthropogenic modification of global processes. following world war ii, the industrial efficiencies of bomb factories were adapted to production of agricultural fertilizers. as a consequence, ecological stoichiometry was radically altered. in geological time, this is a short-term experiment and it is not yet clear what the long-term implications will be for global-scale ecosystem processes. indeed, the fertilizers manufactured are typically nutrients that limit productivity. hence it is inevitable that these will impact abundance and distribution of organisms, including disease hosts and vectors. in , researchers convened by the wildlife conservation society (wcs) coined the term ''one world-one health,'' at a time of increasing global interest in connections between emerging infectious diseases and environmental stewardship. what has become the one health movement calls for interdisciplinary and crosssectoral approaches to disease prevention, surveillance, monitoring, control, and mitigation, as well as environmental conservation. the goal of improving lives, with integrated health approaches, has been embraced by veterinary, medical, public health, agricultural, and environmental health organizations in the one health initiative. this movement has helped integrate ideas from environmental, veterinary, and agricultural science with public health, and has been successful in bringing broader attention to socio-economic influences on human and animal health. ecohealth emerged in the s from an interest in connecting ecosystems and health through the original work of the international development research council (idrc) (lebel ) . the ecohealth community has since grown to include researchers from a broad range of disciplines, all of whom share an interest in the intersection of ecology and health. humans must be included in ecohealth models and wildlife in one health models. otherwise, our understanding of disease risk cannot be complete. conceptual and mathematical models from the social sciences and public health can usefully be combined with those developed for agriculture and ecology. thus, the coupled socio-ecological models will allow characterization of emerging systems, with the challenge of capturing non-linear complex behaviors. in conclusion, the dimensions of ecological approaches to public health that we propose in this chapter are, in essence, networks of population dynamics, community structure, and ecosystem matrices incorporating concepts of complexity, resilience, and biogeochemical processes. case studies disease emergence can strongly impact the abundance and diversity of wildlife populations. the dynamics of wolf and moose populations on isle royale is a classic case study. the single predator-prey dynamic is unique in its simplicity and is one of the longest studied. the system has never achieved equilibrium and cannot be explained either by top-down control of moose abundance by wolf predation or bottom-up control of wolf abundance by moose availability (vucetich et al. ) . moreover, the system exhibits both influences, with episodic disturbances from disease and climate. the introduction of parvovirus by a domestic dog caused the wolf population to crash in . subsequently, the moose population exploded which impacted balsam fir, their winter food. consequently, in the moose population crashed during a harsh winter. moose are mega-herbivores (owen-smith ) that grow sufficiently large to escape predation from wolves, so wolves are only able to prey on the young and infirm. the moose are vulnerable to ticks, which contributes to poor body condition and makes them more vulnerable to wolf predation. ultimately, the dynamics of an invasive disease agent influenced community structure, as did predation, resource availability, parasitism, abiotic conditions, and genetic diversity. these events challenged the certainty of predictive models of population dynamics and community structure. this case study illustrates the difficulty of modeling eids in relation to ecosystem dynamics. correlation of the incidence and intensity of cholera, primarily a waterborne disease, with environmental parameters, e.g., temperature, salinity, nutrients, conductivity, and other factors, including rainfall, extreme weather events, and with access or lack of access of the populace to safe water and sanitation has been studied by many investigators over the past years. the observation of colwell and huq ( ) that the causative agent of cholera, vibrio cholerae, is a commensal of zooplankton, predominantly copepods, led to examination of the annual incidence of cholera in bangladesh. controlling factors were determined to be water temperature and salinity, but also relationship to the annual cycle of plankton (colwell ) . the annual bimodal peaks of cholera in bangladesh (spring and fall) correlated with plankton blooms in the spring and fall, with copepods proving to be a vector for v. cholerae (de magny et al. ) . further studies, employing satellite remote sensing to monitor chlorophyll, sea surface temperature, and sea surface height in the bay of bengal, provided useful models of the relationship of cholera and climate (lobitz et al. ) . refinement of the models and detailed analyses of the river system of the ganges delta led to further and more detailed characterization of the drivers of the spring and fall cholera outbreaks, namely rainfall, river height and flow, and salinity (jutla et al. ) . cholera, and very likely other waterborne diseases, can be tracked to their environmental source (jutla et al. ) . thus, ecology of the v. cholerae proved to be key in understanding incidence of the disease (colwell et al. ; lipp et al. ) . based on ecology and evolution of v. cholerae, predicting cholera incidence in various regions of the world is promising. in fact, preliminary results demonstrate effectiveness of regional hydroclimatology combined with satellite data for cholera prediction models for coastal regions in south asia and sub-saharan africa, providing lead time to strengthen intervention efforts before the seasonal outbreaks of cholera occur in these endemic regions. the role of wildlife and livestock in the transmission of infectious agents to humans has been recognized for decades (karesh et al. ). zoonoses such as rabies remain endemic in wildlife and continue to spillover to people as they have done for probably centuries. however, the importance of wildlife from which pathogens are transmitted has become critical in the era of eids. the majority of eids are zoonotic and originate in wildlife (jones et al. ). pathogens such as nipah virus (niv), sars coronavirus, and ebola virus originate in wildlife species from tropical or subtropical regions, where human population density is high, and rapid changes to the environment drive increasing risk of spillover. the role of ecology in understanding patterns of zoonotic disease emergence is significant and ecologists need to be integrated into one health efforts. traditional epidemiological investigations of emerging zoonoses focus on the network of human cases affected by an eid, tracing back to origins and examining risk behavior. unfortunately, studies tend to view the role of wildlife as a risk factor for spillover and rarely involve detailed studies of wildlife population dynamics. for example, fruit bats were identified as the reservoir of nipah virus (niv) in malaysia and are, therefore, a risk factor for its emergence elsewhere. in malaysia, niv first emerged in pig farms close to fruit bat habitats. it was hypothesized that the intensive nature of the farms were the trigger for its emergence (chua et al. ). an alternative hypothesis was that bats brought the virus into the country from nearby sumatra following forest fires there during a severe el nino event (chua et al. ) . a collaborative group including wildlife biologists, veterinarians, virologists, mathematical modelers, physicians, and epidemiologists collected and analyzed data on the hunting of bats, pig population dynamics at the index farm, large-scale movement of fruit bats and the capacity of the virus to survive in urine, saliva, and fruit juices (pulliam et al. ) . this work was able to demonstrate that the continued presence of bats in the index farm region, and the particular dynamics of intensive production allowed the virus to invade the pig farm, produce a partially immune population of pigs, then re-invade to create a long-term exposure of pig workers, and the large-scale outbreak observed (pulliam et al. ) . early epidemiological studies of the emergence of niv in bangladesh identified drinking of date palm sap as a risk factors, and suggested that this might be due to contamination of the collecting pots by fruit bats (luby et al. ) . subsequent investigations involved wildlife biologists who used infrared cameras to confirm contamination in the field (khan et al. ) , and conducted longitudinal surveillance of bat populations to examine whether seasonal patterns exist that could be used to estimate risk. these studies demonstrate the value of analyzing wildlife reservoir ecology in tandem with epidemiological and specific disease investigations. such an approach will become increasingly important, given the disproportionate rise in eids originating from wildlife over the last few decades (jones et al. ) . emerging infectious diseases of plants: pathogen pollution, climate change and agrotechnology drivers the ecological role of water-column microbes in the sea experimental manipulation of predation risk and food quality: effect on grazing behaviour in a central-place foraging herbivore ecology: individuals, populations and communities. blackwell science, oxford bisby fa ( ) characterization of biodiversity early onset of secondary extinctions in ecological communities following the loss of top predators leading indicators of trophic cascades nipah virus: a recently emergent deadly paramyxovirus anthropogenic deforestation, el nino and the emergence of nipah virus in malaysia diseases of humans and their domestic mammals: pathogen characteristics, host range and the risk of emergence plant succession; an analysis of the development of vegetation. carnegie institution of washington, washington cohen je ( ) food webs and niche space environmental reservoir of vibrio cholerae the causative agent of cholera vibrio cholerae, vibrio parahaemolyticus, and other vibrios: occurrence and distribution in chesapeake bay raymond lindeman and the trophic-dynamic concept in ecology emerging infectious diseases: bridging the gap between humans and wildlife environmental signatures associated with cholera epidemics trophic control of mesopredators in terrestrial ecosystems: topdown or bottom-up? stoichiometric constraints on food-web dynamics: a whole-lake experiment on the canadian shield predator diversity and the functioning of ecosystems: the role of intraguild predation in dampening trophic cascades the lake as a microcosm the individualistic concept of the plant association ueber die fossilen medusen der jura-zeit community structure, population control, and competition an assessment of several of the historically most influential theoretical models used in ecology and of the data provided in their support biodiversity of plankton by species oscillations and chaos influence of eutrophication on disease in aquatic ecosystems: patterns, processes, and predictions organisms as ecosystem engineers global trends in emerging infectious diseases partitioning diversity into independent alpha and beta components tracking cholera in coastal regions using satellite observations the ecology of zoonoses: their natural and unnatural histories use of infrared camera to understand bats' access to date palm sap: implications for preventing nipah virus transmission are there general laws in ecology health: an ecosystem approach. international development research centre, ottawa levins, r ( ) evolution in changing environments effects of global climate on infectious disease: the cholera model climate and infectious disease: use of remote sensing for detection of vibrio cholerae by indirect measurement foodborne transmission of nipah virus land-atmosphere interaction in a semiarid region: the bunny fence experiment hotspots: earth's biologically richest and most endangered terrestrial ecoregions. conservation international, cemex sa de cv, agrupación sierra madre, mexico city murray bg ( ) can the population regulation controversy be buried and forgotten the strategy of ecosystem development parallel ecological networks in ecosystems deforestation and malaria in mâncio lima county biodiversity and disease risk: the case of lyme disease megaherbivores: the influence of very large body size on ecology agricultural intensification, priming for persistence and the emergence of nipah virus: a lethal bat-borne zoonosis self-organized patchiness and catastrophic shifts in ecosystems catastrophic regime shifts in ecosystems: linking theory to observation mechanistic approaches to community ecology: a new reductionism? habitat modification alters the structure of tropical host-parasitoid food webs do alternate stable states occur in natural ecosystems? evidence from a tidal flat scale dependent feedback and regular spatial patterns in young mussel beds predicting prey population dynamics from kill rate, predation rate and predator-prey ratios in three wolf-ungulate systems communities and ecosystems: linking the aboveground and belowground components a review of trait-mediated indirect interactions in ecological communities evolution and measurement of species diversity in: frumkin h (ed) environmental health: from global to local the concept of organisms as ecosystem engineers ten years on: progress, limitations, and challenges acknowledgments we thank alexa frank (ecohealth alliance) and norma brinkley (university of maryland) for invaluable assistance in the preparation of this chapter.the human environment interface key: cord- -xedqhl m authors: lister, graham; lee, kelley title: the process and practice of negotiation date: - - journal: global health diplomacy doi: . / - - - - _ sha: doc_id: cord_uid: xedqhl m global health diplomacy has been defined as the art and practice of negotiation in relation to global health issues. this chapter draws on generic concepts of negotiation as a process of diagnosis, formula development, exchange and implementation, reflecting the shared and sometimes contested values, power relationships and interests of the many different actors involved. it sets out a framework for understanding the main phases of global health negotiation process as they arise in many different contexts. the negotiation of global health issues is shown to be a driver of the regimes of global health governance institutions that are shaped by the new trends in global governance described in the previous chapter. the leadership and development of diplomatic negotiations at every level with an increasing range of actors is therefore key to global governance for health. global health diplomacy has been de fi ned as the art and practice of negotiation in relation to global health issues. this chapter draws on generic concepts of negotiation as a process of diagnosis, formula development, exchange and implementation, re fl ecting the shared and sometimes contested values, power relationships and interests of the many different actors involved. it sets out a framework for understanding the main phases of global health negotiation process as they arise in many different contexts. the negotiation of global health issues is shown to be a driver of the regimes of global health governance institutions that are shaped by the new trends in global governance described in the previous chapter. the leadership and development of diplomatic negotiation s at every level with an increasing range of actors is therefore key to global governance for health. negotiation can be de fi ned as a process of exchange between two or more interested parties for the purpose of reaching agreement on issues of mutual concern. zartman and berman ( ) distinguish three main phases leading to agreement: the diagnostic phase, during which the issues are identi fi ed, stakeholders engaged and information is prepared, the formula phase, establishing a shared framework for agreement including the process of exchange and the detailed phase of negotiation and exchange. negotiation is also crucial to the effective implementation of any international agreement, requiring ongoing monitoring and possibly arbitration of disputes by an international body. negotiation can be characterized in terms of the expression of values and power. global health negotiations often invoke shared values and goals, though interpretation and interests may differ. as fisher et al. ( ) note, negotiations based on common principles are fundamentally different to negotiations based on positional power. where values are shared, stakeholders are more likely to seek, as a minimum, to accommodate the speci fi c interpretations and interests of each party. more constructively they may collaborate to fi nd new solutions to mutually recognized problems. where values are not shared, stakeholders are more likely, either to avoid the issues or to seek to develop a position of advantage to advance one interest over another. while in the former case there are great advantages in sharing information and working for a "win-win" integrative solution, in the latter case the sides may understanding the negotiating process from diagnosis of issues and • interests, the establishment of a formula to provide a framework for resolution of con fl icting interests to the detailed process of negotiating exchanges to resolve the issues. the need to de fi ne and frame the issue in a way that can be accepted and • addressed by all parties to negotiations. the importance of engaging relevant stakeholders and aligning their • interests. the key role of information and knowledge in preparing a negotiating • position. the design of the process and formula for the process of detailed • negotiation. insights for the conduct of detailed negotiation and exchange and in par-• ticular the importance of timing. the importance of continuing negotiation in the implementation of inter-• national treaties or agreements. the exercise of • meta leadership in global health negotiations . wish to apply game-theory based strategies that emphasize their position or the extent of the power of one side in relation to the other, it is assumed that one side wins at the expense of the other. the ethical values of health as human rights are generally recognized by all the parties as de fi ned in the constitution of the who and this can provide a basis for the negotiation of outcomes that can be considered "fair" in these terms. but even values such as fairness and rights to health may be interpreted in different ways. moreover, it is also clear that the other interests of the parties, as examples: their trade, economic, and security concerns shape their interpretation of health values. thus while global health negotiations tend to be couched in terms of the expression of shared values and concerns for health, it is also possible to discern the interplay between the speci fi c interests and powers of the parties. global health negotiations can arise in many different ways in relation to threats posed by different diseases and determinants of health or as a consequence of other foreign policy issues such as security and trade. they often involve multiple stakeholders and interests, both because they deal with trans-border issues and because health and its determinants, including globalization, have impacts across all social and economic spheres. the health issues negotiated are often uncertain in their long-term impact and capable of different interpretation, thus an agreed evidence base and effective presentation of information are essential during the negotiation of international agreements and in their implementation. for these reasons the negotiation of global health issues can be protracted and though agreements to joint action on health emergencies are often reached within days, this may re fl ect years of preparation and exchange. where issues arise within other policy spheres the process can sometimes be very protracted but can be hastened by international events as shown by the negotiation of trade related aspects of intellectual property (trips) and access to medicines. world trade organisation negotiations on trips were fi rst concluded as part of the uruguay round of the general agreement on tariffs and trade (gatt) in . this reinforced the protection of intellectual property rights including those applying to pharmaceuticals, for all countries joining the wto. the agreement was negotiated purely as a trade concern without regard to public health consequences. as hiv/aids and other global health issues gained increasing prominence many resource poor countries and international civil society groups found that trips presented a further obstacle to access to affordable medicines. this issue came to the fore when the government of south africa passed the medicines act in . this was intended to enable the sa government to license the production of drugs to treat some of the complications of hiv/ (continued) in global health negotiations the fi rst step is the identi fi cation of issues that are ready or "ripe" for resolution and to frame them in a way that all parties can recognize. this must invoke a common recognition of a problem and the moral and practical case for action. the time when an issue is "ripe" for resolution may depend on box (continued) aids, thus avoiding patent restrictions. an international group of pharmaceutical companies challenged the legality of the act in the pretoria high court. this challenge might have succeeded, but for the intervention of a local civil society group called the treatment action campaign (tac) who alerted the international network of civil society groups in this fi eld and won the right to present their case in court. protests grew around the world and in the face of this the pharmaceutical fi rms withdrew their challenge. as a result the legislation was applied more widely than had originally been intended, particularly in relation to hiv/aids medicines and other countries followed south africa's lead in passing similar measures. the public awareness raised by this case was one of the factors that led to the partial resolution of this issue in the wto resolutions of and (see box ). an illustration of how events can raise awareness of issues and thus facilitate negotiations is provided by lee (forthcoming ) who describes negotiations to revise the international health regulations, initiated by a resolution of the world health assembly (wha) in amid concerns about emerging and re-emerging diseases. while a revision process commenced, progress proved glacial due to the lack of interest and support by key member states. it was not until the outbreak of severe acute respiratory syndrome (sars) in - that suf fi cient political priority was forthcoming. this led to concerted efforts, under the auspices of an intergovernmental working group on the revision of the international health regulations, which reached agreement on the revised ihr ( ) which countries have adopted. factors such as the emergence of research evidence, the response to a crisis or simply as a result of ongoing international discussions. issues for global health negotiations are identi fi ed in many different ways: as a result of the policy leadership role of who, as an outcome of a speci fi c review, or a concern of national governments or groups such as g or the eu. issues may also be raised by civil society groups or as a result of negotiations in spheres not previously associated with health such as the world trade organisation. but it is not a simple matter to introduce a new issue to the crowded agenda of global health diplomacy. moreover the way in which an issue is framed, how it is identi fi ed and the policy context in which it is viewed is crucial to subsequent global health negotiations. as labonté and gagnon ( ) note, global health issues arise in many different policy frames : security, development, global public goods, human rights, trade and ethical/moral reasoning. this question has still not been fully resolved as the declaration was only • implemented in by the wto general council as a temporary waiver of trips rules. as a consequence negotiations on the application of paragraphs - of the doha declaration that permit the compulsory licensing of drugs (circumventing patent rights) in response to threats to public health considered to be a national emergency or other circumstance of extreme urgency must be negotiated on a case-by-case basis in the light of local conditions (see box ). however the issues are identi fi ed, it is important to raise the policy questions in a way that will be recognized by all relevant stakeholders. this does not mean pandering to the lowest common denominator but it does require the legitimate interests of all parties necessary for eventual agreement to be acknowledged. the policy lens or frame applied to the issue may also determine the fora at which the issue will be raised and the way it will be resolved. one dif fi culty faced by many of the government and interstate institutions traditionally engaged in global health diplomacy is that their commitment to existing policy frame s and ongoing international regimes may make it dif fi cult for them to identify and raise new issues. for this reason civil society organizations including advocacy groups and foundations that are less bound by formal roles and positions can sometimes play an important role as in stimulating new thinking to identify and frame issues. a second step during diagnosis can be described as engagement of stakeholders or the alignment of interests . this involves exploring the perspectives and points of agreement and disagreement between all relevant parties. the parties establish their respective negotiating stances build relationships and common understanding between aligned groups and, if they are wise, explore the positions of other parties. in the context of global health negotiations the alignment of interests may include developing a shared position amongst regional or other international groups of states such as the eu, g /g and south-south cooperation. it may also include the alignment of actors at national level to develop national global health strategies. but it is not just states that come together in this way, civil society groups and other actors may also seek to establish shared positions to strengthen their advocacy for action on global health issues. proposals for an international convention on tobacco control were fi rst raised at the ninth world congress on tobacco or health in , which resulted in a proposal to the wha meeting of . following this the who considered various formulae for such a convention, and it was decided to try to produce a framework convention to promote international and national action. this was accepted at the wha meeting of . an international negotiating board (inb) was formed which negotiated the wording of the convention over two years. in the framework convention on tobacco control (fctc) was adopted by the wha, the convention came into effect in after -member states had signed, often following internal dialogue. by , countries had signed, of these including the usa have yet to bring the fctc into national laws by formal rati fi cation. (continued) the interests of stakeholders and consortia de fi ned at this stage should clarify the shared goals that provide the basis for aligning interests. depending upon circumstances it may be that the negotiating strength of a group or consortium is best served by acting together as a negotiating bloc or acting as separate agents with common interests. for example, in certain fora the interests of civil society groups may be most effectively expressed as a single voice, but in other circumstances they may be more effective when supporting a common view from different perspectives. stakeholders may also indicate certain sticking points, for example it may be that some governments would be unable to countenance certain forms of prohibition of tobacco use, or would not accept the political and economic impact of limiting alcohol marketing. this will indicate the points at which these parties would walk away from negotiations, it is therefore important either to fi nd a way round such sticking points or to develop new creative solutions to overcome such barriers. it is important to understand the walk away points for all parties to a negotiation as these de fi ne the negotiating space . while this may seem a long drawn-out process, agreement on the fctc was relatively swift compared to other international agreements and laws. and while the issues were intensively negotiated from to the preparation of the grounds for such an agreement by building national awareness and action was a much longer process. brazil was the second country to introduce graphic warnings on cigarette packs, it has a history of awareness raising and controls on tobacco stretching back to . its programme of public engagement and working with civil society organizations to reduce smoking rates is regarded as exemplary and perhaps for this reason and because of the growing importance of emerging countries such as brazil, russia, india, china and south africa in international fora-and as target markets for tobacco companies, brazil was invited to chair the inb. this is described by lee et al. ( ) as an example of the way brazil has deployed "soft power" in global health. it is a tribute to the diplomatic skills of those who negotiated the fctc that so many countries and organizations from the european union to national patient groups feel that they have played an important role in its formulation. consultations within and between countries ensured a coalition of interests was created capable of withstanding the tobacco companies, who were clearly intent on defending their position. instead of ignoring them who initiated public hearings both at international and regional levels to make the consultation process open to them but also transparent to public opinion. effective information gathering and use is essential for global health negotiations . information will be of greatest value once the concerns of all relevant stakeholders are identi fi ed as it is then possible to gather information and moral and policy arguments to address the issues of greatest contention in subsequent exchanges. the way in which information is used and publicized is also vitally important to global health negotiations , which are usually conducted in public, or at least in an open transparent process. scienti fi c papers may be appropriate sources for data but will seldom present information in a way that is most amenable to policy makers or public discussion. civil society organizations often have more freedom to advocate for a policy case than other parties and can be important in raising public awareness and support for policy change. they may appeal to the public through traditional and new media and, for example, by utilizing celebrity power. in the period leading up to formal exchange the parties to a negotiation often produce initial position papers setting out their aims and objectives and the relevant evidence on which they draw. they may seek to form a wider coalition for their position by conducting consultations with other parties and groups. this brings a danger that they may trap themselves into commitments that provide no room for negotiation. thus it is important for global health diplomacy to ensure that the interests of all parties are recognized and that positions statements focus on values and goals rather than speci fi c solutions to the exclusion of other options. the exchange of views during the diagnosis phase helps to ensure there is a shared understanding of the issue to resolve differences of interpretation and to focus negotiations on points of contention. it should also help each of the parties to understand the perspectives of the others which may be constrained by national economic, cultural, and political circumstances. technical knowledge may also be required as global health issues often require some understanding of public health impacts or options for cost-effective intervention. where a health issue involves other policy sectors, such as trade, agriculture or the environment, cross-sector knowledge is essential. the dispute between the ministry of health in thailand and the pharmaceutical company abbott laboratories over the compulsory licensing of the hiv/aids drug kaletra (a combination of ritonavir and lopinavir) described by lee ( in press ) illustrates the need to bring together different types of technical knowledge. negotiations between the ministry and private company required specialist knowledge of the drugs themselves and their effectiveness, knowledge of public health conditions and speci fi cally the prevalence of hiv/aids and access to relevant medicines in thailand as well (continued) once the issues have been clari fi ed and information and interests shared, it may be realized that the parties can proceed directly to agreement. however, as many global health issues are complex and multi-faceted it may be necessary to design a speci fi c formula for agreement for the resolution of outstanding issues. the formula de fi nes the negotiating space (the limits within which agreement can be reached) and the terms in which agreement will be reached. it is important for the formula to be kept relatively simple but with suf fi cient scope to allow all parties to bene fi t from the eventual agreement. the formula identi fi es the points of disagreement and the terms in which these will be negotiated. thus for example in relation to tobacco control a study was carried out to determine the form of agreement that would be most appropriate and most likely to gain support from member states of the who. the design of the detailed negotiating process requires agreement upon: the objectives of discussion, the issues to be resolved and the broad principles • on which agreement might be based. the participants including representatives of groups of states and possibly civil • society organizations that might be invited as participants or observers. the forum for discussion, which might be an existing international agency such • as the wha or united nations general assembly or a special meeting or discussion process at some neutral location. the chair and secretariat to mediate the meeting, agreeable to all parties. • the process of the meeting including the timescale, stages of negotiation, • arrangements for media coverage and the issue of communiqués. details of meeting arrangements such as the layout, provision for break out dis-• cussions and other factors that affect the atmosphere of the exchange. the method of agreement whether by consensus, voting or informal agreement • subject to later rati fi cation . the language(s) of the agreement can be important since languages impart cul-• tural assumptions and some allow greater ambiguity of expression than others. participants in such exchanges will also need to establish their own rules of engagement, for example who will lead the delegation, what are their negotiating box (continued) as detailed understanding of the legal fl exibilities available under the trips agreement, and its interpretation in the subsequent decisions on the implementation of paragraphs - of the doha declaration on the trips agreement and public health. objectives and walk away points and what freedom do they have to negotiate compromises, to what extent can they represent other members of a group and how will they report back to the governments or groups that they represent. the processes of framing the issue, the alignment of interests , gathering and using information and design of the formula for agreement can be seen as steps in preparation for detailed negotiations, which as drager et al. ( ) note is of fundamental importance to the success of health negotiations. in conventional negotiation theory bargaining is often characterized by strategic offers and counter offers, with trades proceeding from larger scale claims and concessions to smaller adjustments as differences between parties are resolved. there may be elements of game theory applied with opening moves design to probe the position of others rather as in a chess game. while elements of this sort of bargaining can be seen in global health negotiation it is more likely that issues will be resolved through a managed process of exchange in accordance with a process designed as described in the previous section. before commencing the detailed exchange process the secretariat may produce an outline draft as a basis for negotiation. this may establish principles for the resolution of issues with areas of disagreement couched in broad terms acceptable to most participants for more detailed discussion. the initial draft may be itself a product of prior discussion and negotiation since, as in any negotiation, an opening proposition can anchor expectations as to the outcome and may de fi ne what would be considered success or failure in the talks. setting expectations too high can be a mistake as it can lead to a perception of failure if they are not met, expectations set too low may result in outcomes that do not challenge participants to seek creative solutions. typically the parties reviewing the draft will identify areas which they would wish to see amended and various changes in wording will be proposed to the secretariat and discussed in detailed sessions before agreeing upon a communiqué signifying general agreement. headline discussions may be accompanied by other forms of diplomacy and exchange to resolve misunderstanding and barriers to agreement. for example, where a policy may have a fi nancial impact on one or more countries, there may be side room discussions of mechanisms to offset or reduce the economic impact by aid or trade mechanisms. civil society organizations may exert moral pressure on negotiators from the perspectives they bring of people affected by the policy and by astute use of the media. the search for agreement can be described as a process in which a range of reciprocal exchanges builds mutual obligation and understanding on which broader agreements can be based. the participants in most global health negotiations seek an outcome from which all parties can claim success. this is essential since although agreements may be rati fi ed and set in international law, compliance depends largely upon the willing acceptance of the agreement by the signatories. theoretical models of negotiation stress the importance of con fi rming the agreement, it is often said that nothing is agreed until everything is agreed. the point at which a negotiation culminates in an agreement is therefore of great importance. this can also be true of agreements on global health, many of which are negotiated "down to the wire". while agreement to a communiqués may be seen as a successful outcome to detailed negotiation, in many cases there will be a further stage in which the agreement is formally agreed by a un body with the legal status required to establish international law. this will require careful wording of agreements to be signed, together with clear proposals for monitoring its observance. terms included in the document and the legal obligations assumed by signatories to the agreement should be as clear as possible, though some parties may intentionally leave "wiggle room" for subsequent interpretation. in many cases states sign an agreement but reserve the right to con fi rm their legal assent to the law in national legislation. this may be because internal political mechanisms require the agreement of legislative bodies, particularly in federal states such as the usa. thus in the case of the fctc outlined in box , while president bush signed the convention he did not submit it for senate approval. it may seem that there should be no further negotiation of the terms of an international treaty between the acceptance of a communiqué and rati fi cation . but in practice there are often further negotiations at the time of rati fi cation and subsequent adoption and implementation by states. discussions at this stage will focus on the de fi nition of terms and their speci fi c application, how agreements are monitored and on the conjuncture of different international obligations. these are often the most dif fi cult and crucial issues. moreover as spector and zartman ( ) note, effective implementation of any international agreement requires ongoing monitoring over many years. whether issues can be resolved by conciliation between the states, by arbitration by an international agency or by reference to the international court of justice will often depend upon circumstances. the who may be required to examine the performance of states and raise questions about the extent of their observance of global treaties. international agreements thus help to de fi ne the roles and regimes of agencies like who in global governance. and as the role and functions of international agencies evolves this will in turn in fl uence the way international agreements are applied. thus global health negotiation can be seen as a mechanism that drives the ongoing evolution of global governance for health as an open system responding to its geopolitical context. since global health treaties and agreements often also imply a moral obligation, there is a further "court" at which disputes can be raised, which is the court of public opinion. civil society organizations often play a valuable role in holding governments or international companies to account in this way, pointing out infringements of human rights or failures to meet their obligation under international agreements and laws. chapter discusses the leadership role of who in global health negotiations . but organizational leadership is also essential for the negotiation of global health issues at regional, national and local levels. this is not achieved by command and control, planning and budgeting or by evidence and analysis alone, but by working with others to share ownership of and responsibility for global health and build mutual respect and trust. discussion of the negotiation process would be incomplete without recognition of the importance of the skills required to lead such negotiations. the examples given in later chapters provide many instances of the ways in which personal leadership has brought people from different countries and organizations together to achieve common goals. the qualities required are described by marcus et al. ( ) , as "meta leadership", which requires: an encompassing vision of the values of global health, the political context and • the situation as seen from all perspectives, in order to frame the issue in a way that can be accepted by all participants. the epicenter of this outbreak with more con fi rmed human cases and deaths from the disease than any other country. stopping virus sharing was therefore seen as a serious threat to measures to counter a potential global pandemic. the indonesian government claimed that samples were being used by pharmaceutical companies to produce patented vaccines for high-income countries which would be unaffordable to indonesia. moreover they pointed out that the convention on biological diversity of requires that countries from which genetic material is drawn should share the bene fi ts of its use. what followed from this dispute was a protracted negotiation of the interpretation of the international health regulation and other international agreements which affect the conditions applied to the sharing of virus samples. these negotiations described by irwin ( ) are still ongoing, they invoke wider issues concerning capacity for vaccine production, the rights of states to share the bene fi ts of virus sharing, the role of who and funding of global public goods for health. the emotional intelligence required to understand and empathize with different • perspectives and in fl uence thinking and action across national, cultural and institutional boundaries by engendering shared understanding and common purpose. the ability to encourage and draw on shared leadership from other individuals, • institutions and organizations with different skills and perspectives to empower them to act together to achieve common goals. the personal integrity, self-awareness and self-control required to lead negotia-• tions unbiased by any prejudgement, to "speak truth to power" where necessary and thereby earn the trust of people from different countries and organizations. meta leadership is demonstrated by many of the practical examples as shown in all chapters of this book, it is best learnt by re fl ecting on experience of leading global health negotiations, perhaps fi rst across local organizations and then with increasingly challenging international contexts. complex international interdisciplinary negotiation often requires distributed leadership at many different levels as shown in the south african access to medicines case introduced in box . the south african medicines act of was signed into law by president nelson mandela, but by , when the issue came to the pretoria high court, the new president thabo mbeki was denying the existence of hiv/aids and his health ministers were falling into line. despite the strong institutional and personal support for south africa's position by dr gro harlem brundtland of the who, it was felt that the pharmaceutical companies would win their appeal against the act and fearing this implementation of the act was suspended. the pharmaceutical manufacturers association seemed certain to win, they even appeared to have the backing of ko fi annan, the eu and the usa. one man called zackie achtmat, a gay hiv-positive south african of mixed race, made a difference. leading the tac he vowed not to take antiretroviral treatment until it was available to all south africans. tac won the right to present their case in court. and they made their voices heard beyond south africa. working with international gay and lesbian groups and the support of ngos led by ellen't hoen of médecins sans frontières they built a worldwide campaign for access to medicines that ensured that clinton and annan shifted their rhetoric and european countries began to back down. facing mounting public disapproval the pharmaceutical companies withdrew their case in a meeting with nelson mandela. zackie continued to campaign against thabo mbeki's refusal to fully fund hiv/aids treatment and eventually became seriously ill until persuaded by a personal appeal from nelson mandela to abandon his pledge to refuse treatment. experience of global health negotiations shows the importance of sound diagnosis including the way issues are framed, the alignment of interests and the development and presentation of information. this can help to prepare for the time when the issue is ripe for resolution, perhaps as a result of unfolding events or as a shared understanding of common interests and concerns for global public goods emerges. the formula for the resolution of issues including consideration of the form and nature of any international agreement and the terms in which it can be resolved is crucial to successful negotiation of an agreement. but even when formal agreement is reached diplomatic negotiations centred on the international agency responsible for monitoring the agreement are likely to continue. such negotiations shape the roles and regimes of the international agencies and are the essential basis for global governance for health. while this calls for shared organization leadership at every level it also depends upon on the personal leadership qualities of key individuals. does everyone interpret human rights to health in the same way? if not why not? . describe a negotiation process for a health issue with which you are familiar give examples of global health issues arising in other policy contextssecurity, trade or development? what are the advantages and disadvantages of forming a group of nations or a coalition of civil society organizations to press for global health policy change? . if you are to take part in a consultation on a global health issue what information would you seek? what do you think are the most important points to consider in setting up a global health negotiating process? what can ensure that an international agreement on a global health issue is implemented effectively, what can go wrong? what competence do you feel you have to lead global health negotiations , how can you build your capability in this fi eld? . who showed leadership in the south africa access to medicines case and who did not? references drager getting to yes: negotiating an agreement without giving in . london: random house business books indonesia, h n , and global health diplomacy framing health and foreign policy: lessons for global health diplomacy twenty-fi rst century global health diplomacy brazil and the framework convention on tobacco control: global health diplomacy as soft power renegotiating health care: resolving con fl ict to build collaboration getting it done: post agreement negotiation and international regimes . washington dc: united states institute of peace press. an analysis of the link between diplomatic negotiations of the implementation of international agreements and the regimes of global governance institutions the practical negotiator further reading negotiation, chapter manual for un delegates, conference process, procedure and negotiation key: cord- - bp qpte authors: gable, lance; hodge, james g. title: public health law and biological terrorism date: - - journal: beyond anthrax doi: . / - - - - _ sha: doc_id: cord_uid: bp qpte nan result in significant illnesses or casualties [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . consequently, proactive preparations for bioterrorism, even more so than other types of terrorism, involve systematic planning, ongoing training, and redistributions of resources. the prospect of bioterrorism has galvanized widespread support for improved preparedness within federal, state, and local governments and the health care sector throughout the united states. these efforts have targeted a wide range of relevant and intersecting areas. strengthening the public health workforce, infrastructure, and capacity available to respond to an outbreak associated with biological terrorism, is critical. policy-makers have responded by increasing training and funding to these areas [ ] [ ] [ ] . similarly, planners within the public and private sectors have established tactics and procedures to respond to various emergency scenarios. these plans frequently consider methods to improve communications between various emergency responders and others who must have sufficient capability to contact each other in an emergency situation. preparedness planning efforts targeting bioterrorism have occurred concurrently with initiatives to bolster public health infrastructure for other public health emergencies including natural disasters (e.g., hurricanes) and naturally occurring disease outbreaks (e.g., pandemic influenza). finally, preparedness planners have considered some of the ethical concerns raised by bioterrorism attacks and their potentially devastating consequences. a foundational component of these preparedness efforts has been the potential modernization of state and federal public health and emergency response laws. law is a critical component of a well-developed public health system [ ] . public health law grants public health agencies powers to detect, track, prevent, and contain health threats resulting from bioterrorism and other public health emergencies. however, many existing public health and emergency response laws at the state and federal levels may not be sufficient to address biological terrorism. these laws often do not grant public health authorities the necessary powers to stop an outbreak. public health laws vary widely across different jurisdictions. as a result, the legal powers ascribed to public health officials may be different in scope and function in different locales. these laws are also commonly targeted to specific diseases or conditions that may not relate to emerging threats [ ] . public health powers typically lie at the state and local levels of government. the federal government plays a more limited role for practical and legal reasons. public health falls within the state's police powers, an area of state power traditionally reserved to the states under the tenth amendment to the united states constitution [ ] . the federal government will normally become involved in localized public health matters only at the request of the state or if the disease has the potential to cross state or international borders, or affect interstate interests. from a practical perspective, this gives state and local officials greater autonomy to enact laws and policies conducive to the needs of their communities, without interference from the federal government. responses to bioterrorism, however, will almost certainly involve the federal government, since an infectious disease will rarely be contained within the borders of one state. indeed, an outbreak may traverse international boundaries as well, which would clearly entail the input of the federal government. bioterrorism implicates additional concerns beyond public health, including national security and law enforcement considerations. federal public health and legal authorities may specifically respond to multiple components of a bioterrorism attack, as well as offer guidance and expertise to assist state and local governments in their responses. thus, responses to bioterrorism require sufficient legal powers at both the federal and state levels, in addition to a wellconceived plan for coordinating these powers to maximize public benefit. the debate around bioterrorism preparedness has raised salient questions about the role of law in responding to biological threats, highlighted by inherent tensions between protecting the public and upholding individual rights of liberty, privacy, and freedom of association [ ] . balancing these goals requires difficult choices that are further complicated when public health laws are unclear, poorly drafted, or confusing. to assist state and local law-and policy-makers, public health law scholars at the center for law and the public's health at georgetown university law center and the johns hopkins bloomberg school of public health drafted two model state public health acts. the model state emergency health powers act (msehpa) was drafted quickly after september , , with input from the centers for disease control and prevention (cdc) and multiple national partner organizations [ , ] . completed on december , , msehpa has served as a valuable template for states to modernize their public health laws to address public health emergencies, including emergencies caused by bioterrorism. it provides a modern framework for public health powers, authorizing state and local authorities to engage in a range of activities to address a public health emergency. these measures may restrict temporarily the liberty or property of affected individuals or groups to protect the public's health [ ] . to date, states and the district of columbia have introduced bills based on some or all of the provisions of the msehpa, and states and the district of columbia have passed their respective bills [ ] . the turning point model state public health act (turning point act) (completed on september , ) provides a more comprehensive prototype for state public health law reform [ ] . it covers a broad array of topics that extend well beyond emergency situations, including ( ) defining and authorizing the performance of essential public health services and functions; ( ) improving public health infrastructure; ( ) encouraging cooperation between public and private sectors on public health issues; and ( ) protecting the privacy of identifiable data acquired, used, or disclosed by public health authorities [ ] . a third model law, the uniform emergency volunteer health practitioners act (uevhpa), as drafted in by the national conference of commissioners on uniform state laws, provides a further model for emergency public health governance, organized around the challenge of accommodating health professionals who show up spontaneously at the site of a public health emergency or nearby health facilities in order to provide emergency assistance [ ] . the aforementioned model acts recognize that an effective public health response to a bioterrorism-related outbreak will demand strong and clear legal powers. in the following sections, we focus predominantly on two specific areas of public health powers authorized under law: ( ) restrictions on personal liberty (quarantine, isolation, travel restrictions, privacy) and ( ) restrictions on property (decontamination, use of supplies and facilities, disposal of remains). while other areas of law are also relevant to the legal framework needed to address bioterrorism, these two areas feature the most sustained debates and controversies. each of these powers will be considered in the following sections from a legal and ethical perspective. the release of a highly infectious disease into the population presents government officials with a difficult quandary. within the climate of fear that may surround such an outbreak, public health authorities must quickly and accurately assess the risk to the population and take measures accordingly to protect the public's health. under such circumstances, public health authorities may resort to liberty-limiting measures such as quarantine, isolation, travel restrictions, and privacy limitations. personally restrictive actions are particularly likely when the disease is readily communicable, exceptionally virulent, or is of unknown origin. restrictions on personal liberty to respond to a public health crisis are constitutionally permissible, but the scope of restrictions and attendant protections against their misuse varies significantly across different jurisdictions. quarantine and isolation are among the oldest of public health tools. their use predates modern scientific advances in disease testing and treatment, not to mention modern conceptions of civil liberties. they operate on the most basic principle of infectious disease control-keeping healthy individuals separated from those who have been exposed or infected. in modern times, the mass use of quarantine or isolation has faded as rapid medical tests and effective treatments have become available. when quarantine and isolation have been used, they have been directed predominantly at specific infectious individuals, for example, to control recalcitrant tuberculosis patients [ ] [ ] [ ] [ ] . nevertheless, for a disease of unknown etiology or a disease that poses a significant threat to a vulnerable population, quarantine and isolation may still be effective techniques to contain an outbreak. depending on the scope of the outbreak, largescale quarantine measures may have to be considered. modern logistics surrounding enactment of a large-scale quarantine would be complex and possibly unworkable [ ] . the terms quarantine and isolation have engendered a great deal of confusion. the two terms are often used interchangeably, but in actuality represent distinct concepts. the term quarantine denotes a compulsory physical separation of an individual or a group of healthy people who have been exposed to a contagious disease to prevent transmission during the incubation period of the disease [ ] . historically, quarantine restrictions were often imposed on travelers to insure that they did not introduce a contagious disease into a country or town. the word itself derives from the latin term quadragina and the italian term quarante, which refer to the -day sequestration period enforced on merchant ships during plague outbreaks [ ] . the term isolation, by contrast, means the separation, for the period of communicability, of known infected persons so as to prevent or limit the transmission of the infectious agent [ ] . precise usage of and differentiation between these terms is vital to insure that those subject to these powers receive appropriate treatment and protection. the current legal framework authorizing the use of quarantine and isolation in the united states stretches across multiple jurisdictions and levels of government. quarantine powers were first implemented at the local level, and later the state level, during the colonial period. the federal quarantine statute, first enacted in , authorized the president to assist states in their use of quarantines [ ] . the federal government subsequently took control over maritime quarantines [ ] . this expanded federal role prompted a debate over whether the federal or state government should administer quarantines-a debate which continues to this day. as discussed below, states claim that their quarantine authority derives from their police power, while the federal government argues that its authority arises from its constitutionally -granted power to regulate interstate commerce. state and local jurisdictions have the primary responsibility for quarantine within their borders. the state quarantine power is derived from the state's inherent police power, reserved to the states under the tenth amendment of the united states constitution. most public health powers have traditionally been recognized as falling under the jurisdiction of state and local governments. the united states supreme court has found that the police powers of the state allow the state to enact regulations to protect the health and safety of its citizens [ ] . the use of quarantine and isolation by state and local governments is therefore legally and constitutionally acceptable, provided that these powers are used appropriately to protect public health and safety. the specific scope of state and local quarantine authority varies considerably between jurisdictions. these differences are evident in the structural distribution of power between the state and local governments and the substantive criteria (or lack thereof) for placing an individual under quarantine. some states have a centralized public health system that retains most public health powers at the state level, including quarantine and isolation decisions. other states delegate these decisions to local public health agencies. in these states, quarantine will generally be under the jurisdiction of local public health officials when the disease is confined to a discrete local area. if the outbreak affects more that one community within the state, the state public health authority will usually have the power to implement quarantine or isolation orders. very few jurisdictions have articulated explicit procedures and policies to determine whether or not an individual should be subject to quarantine. both the msehpa and turning point act propose a systematic process for making this determination that considers the exigencies of the situation. furthermore, they allow for an appeal of the decision if possible under the circumstances [ , ] . federal quarantine powers are much more limited than comparable powers at the state level. the federal government may only apply powers delegated to it under the constitution. pursuant to these delegated powers, federal authorities have the ability to prevent the introduction, transmission, and spread of communicable diseases between states and from foreign countries into the united states. the federal quarantine power stipulates that if there is a risk that disease transmission will cross state lines, the federal government has the authority to implement quarantine [ ] . the federal government is additionally authorized to cooperate with state and local authorities to enact quarantine to contain an interstate disease outbreak [ ] . the federal quarantine response is conducted by the cdc, with assistance from other agencies if necessary, including the department of homeland security (dhs), the department of defense (dod), and the department of justice (doj). federal law establishes a role for a number of federal agencies and departments in the execution of a quarantine order. the secretary of health and human services (hhs) has statutory responsibility for preventing the introduction, transmission, and spread of communicable diseases from foreign countries into the united states and within the united states and its territories/possessions [ ] . regulations grant the cdc authority to detain, medically examine, or conditionally release individuals reasonably believed to be carrying a communicable disease [ ] . the cdc's division of global migration and quarantine has the specific authority to quarantine individuals seeking to enter the united states. u.s. customs and border protection (cbp) (formerly the u.s. customs service) and officers of the u.s. coast guard are authorized to assist in the enforcement of federal quarantine orders [ ] . personnel from the u.s. citizenship and immigration services (uscis) (formerly the immigration and naturalization service [ins]), the cbp, the u.s. department of agriculture (usda), and the u.s. fish and wildlife service (usfw) all assist the cdc in identifying travelers or other persons who may be infected with illnesses that pose a risk to public health [ ] . federal quarantine authority only extends to specific diseases enumerated by executive order [ ] . however, this list of diseases can be amended quickly when necessary (e.g., as with sars in , and pandemic flu in ) [ , ] . the federal quarantine power has rarely been used in modern times. therefore, it is unclear how widely it could be used to combat a bioterrorism outbreak. public health law experts have demonstrated concern that the existing legal structures for initiating and managing a large-scale quarantine are inadequate at the federal and state levels [ ] . this is problematic because the imposition of a large-scale quarantine will almost certainly involve the use of federal and state powers. under these circumstances, there is the possibility of confusion and controversy over who is in charge. as past bioterrorism simulations and real emergencies like hurricane katrina have demonstrated, if the lines of authority are not clear to officials at all government levels, the public health response can be paralyzed and undermined [ , , , ] . thus, in addition to improving the legal framework within federal and state/local jurisdictions, serious efforts should focus on establishing a coordinated public health response between these jurisdictions. when should public health authorities use quarantine or isolation to restrict individuals during a bioterrorism emergency? the response to this question requires the decision-maker to balance the need for restrictive intervention with the effect it may have on the civil liberties of affected individuals. modern commentary on the acceptability of quarantine asks whether the risk to the population posed by the disease justifies such a serious loss of liberty [ , , ] . in addition to restrictions on liberty, imposing a quarantine temporarily deprives individuals of their economic livelihood, their right to travel or associate freely with others, and may subject them to stigma and discrimination. in a time of great crisis, public sentiment may strongly support such measures, but public sentiment alone is an insufficient justification to use quarantine powers. these powers may be warranted to prevent the continued transmission of a disease that presents a serious risk to the population. it is important, however, that restrictive powers are not used unnecessarily or as an artifice for discrimination [ ] . past quarantines in the united states have led to violence [ ] , increased disease transmission among the quarantined population [ ] , and biased decision making [ ] . in one case, a federal court invalidated a quarantine imposed on an area of san francisco comprised mostly of persons of chinese descent, finding that the public health officials had used an ''evil eye and an unequal hand'' in issuing their quarantine order [ ] . restrictive public health powers such as quarantine and isolation should be used as a last resort to halt the spread of an infectious disease. the law can provide a useful normative framework for making quarantine decisions. the msehpa, for examples, sets out a list of criteria that should be considered when making a quarantine or isolation decision [ ] . in many situations, particularly where the disease is readily diagnosable and treatable, other options may be more defensible from a medical and civil rights perspective. barbera et al. list three key questions to consider when evaluating a quarantine decision: ''( ) do public health and medical analyses warrant the imposition of large-scale quarantine? ( ) are the implementation and maintenance of largescale quarantine feasible? and ( ) do the potential benefits outweigh the possible adverse consequences? [ ] .' ' gostin has outlined several criteria for exercising restrictive public health powers under modern constitutional law [ , ] : compelling state interest in confinement. public health authorities must only resort to restrictive powers when there is a compelling interest that is substantially furthered by civil confinement. only truly dangerous individuals (i.e., posing a significant risk of transmission) can be confined. whenever possible, risks should be assessed through scientific means. targeted intervention. individually restrictive measures should be well targeted to achieving public health objectives. interventions that deprive individuals of liberty or equal protection without justification may be constitutionally impermissible. for example, placing everyone within a geographic area under quarantine is overinclusive if some members would not transmit infection. underinclusive interventions that confine some, but not all, potentially contagious persons may be found to be arbitrary or intentionally discriminatory. least-restrictive alternative. public health authorities should not implement extremely restrictive measures such as quarantine and isolation if they can accomplish their objectives through less drastic means (although it is not likely that they would be required to enact extreme or unduly expensive means to avoid confinement). safe and habitable environment. quarantine and isolation are intended to promote well-being rather than to punish. therefore, individuals being confined should have access to clean living conditions, food, clothing, water, adequate health care, and means to communicate with others outside the quarantine. procedural due process. individuals subject to confinement for public health purposes must be able to access some form of procedural due process depending on the nature and duration of the restraint. where possible, this process should occur before confinement. if emergency circumstances demand immediate confinement, individuals have the right to request a speedy hearing and counsel to contest their confinement. public health authorities may also take actions during a public health emergency that limit the right to privacy, including public health surveillance, reporting, and contact tracing. the ability to identify and track the spread of infection is a vital component of the public health response to an infectious disease outbreak. public health authorities need access to valid and useful information to accomplish these tasks. in this context, public health surveillance and case reporting are indispensable techniques. surveillance allows public health authorities to collect, analyze, and interpret health information to search for concentrations of disease [ ] . a bioterrorism outbreak could be detected through monitoring large increases in purchases of certain medications from pharmacies, clusters of cases detected by emergency rooms or managed care organizations, or spikes in absenteeism from workplaces and schools. case reporting is a form of passive surveillance involving the routine submission of data to a public health agency by external sources such as health care professionals and laboratories, often pursuant to mandatory legal requirements [ , ] . through disease surveillance and reporting, public health authorities may assess the magnitude of the outbreak and appropriately target resources and tactics [ ] . surveillance and case reporting raise privacy concerns since the reports usually contain identifiable data, which could include a person's name or other identifying characteristics. while using anonymous data instead of identifiable information is preferable to protect privacy, personal identifiers may be necessary to effectively track cases in some circumstances. public health authorities responding to bioterrorism may also wish to engage in contact tracing. contact tracing uses identifiable information to identify and contact persons who have been exposed to potentially infected individuals [ ] . surveillance and contact tracing efforts may be utilized in conjunction with quarantine and isolation measures. this permits public health officials to determine the scope of the outbreak and take necessary measures to reduce the risk of further transmission. activities such as public health surveillance, reporting, and contact tracing test the boundaries of the right to privacy. public health authorities must balance the rights of the individual to control information about their infected status with the rights of the public health authority to collect and use this information to protect others in the community. these tensions may be particularly acute when the biological agent is not well understood. persons who may have come into contact with the agent may choose to not cooperate with public health officials, fearing that the outcome of their cooperation will be a loss of privacy or liberty. they may also fear the stigma that often accompanies persons or groups subjected to coercive public health powers. the use of identifiable information in a public health response to bioterrorism is particularly controversial if public health authorities share information with law enforcement agencies. information sharing between public health and law enforcement agencies may be justified to facilitate a swift response to bioterrorism threats and to apprehend the perpetrators of the outbreak. however, access by law enforcement personnel to identifiable information gathered through public health surveillance further jeopardizes the privacy of these data [ ] . members of the community may be less likely to cooperate with public health officials if they suspect that their data may be revealed to law enforcement officials for purposes unrelated to their health. furthermore, this type of data sharing may undermine the credibility of the public health system by calling into question its fundamental goals and the justifications for engaging in surveillance activities and data collection in the first place [ ] . a bioterrorism outbreak may justify interventions subordinating privacy interests to the common good, but the state must meet several rigorous standards. it must demonstrate that the need for the information is necessary to serve a legitimate public health interest. also, it must attempt to use the least amount of information necessary to achieve this interest. finally, it must conduct its activities openly and transparently, and consult with the affected community. law must allow for public health authorities to use coercive powers to manage property under certain circumstances. there are numerous situations that might require management of property in a public health emergency-for example, decontamination of facilities; acquisition of vaccines, medicines, or hospital beds; or use of private facilities for isolation, quarantine, or disposal of human remains. during the anthrax attacks, public health authorities had to close various public and private facilities for decontamination. consistent with legal fair safeguards, including compensation for takings of private property used for public purposes, clear legal authority is needed to manage property to contain a serious health threat [ ] . once a public health emergency has been declared, the msehpa and turning point act allow authorities the power to seize private property for public use that is reasonable and necessary to respond to the public health emergency. this power includes the ability to use and take temporary control of certain private sector businesses and activities that are of critical importance to epidemic control measures. authorities may take control of landfills and other disposable facilities and services to safely eliminate infectious waste such as bodily fluids, biopsy materials, sharps, and other materials that may contain pathogens that otherwise pose a public health risk. the model acts also authorize public health officials to take possession and dispose of all human remains. health care facilities and supplies may be procured or controlled to treat and care for patients and the general public [ , ] . whenever health authorities take private property to use for public health purposes, constitutional law requires that the property owner be provided just compensation. that is, the state must pay private owners for the use of their property [ ] . correspondingly, the acts require the state to pay just compensation to the owner of any facilities or materials temporarily or permanently procured for public use during an emergency. where public health authorities, however, must condemn or destroy any private property that poses a danger to the public (e.g., equipment that is contaminated with anthrax spores), no compensation to the property owners is required although states may choose to make compensation if they wish [ , ] . under existing legal powers to abate public nuisances, authorities are able to condemn, remove, or destroy any property that may harm the public's health [ ] . other permissible property control measures include restricting certain commercial transactions and practices (e.g., price gouging) to address problems arising from the scarcity of resources that often accompanies public health emergencies. the msehpa and turning point acts allow public health officials to regulate the distribution of scarce health care supplies and to control the price of critical items during an emergency. in addition, authorities may seek the assistance of health care providers to perform medical examination and testing services [ , ] . while the proposed use of these property control measures is not without controversy, they may provide public health authorities with important powers to more rapidly address an ongoing public health emergency. the complex and unpredictable threat of bioterrorism demands a serious effort to comprehensively strengthen all areas of public health preparedness. ongoing changes in public health practice help improve preparedness. public health authorities at the national, state, and local levels must also be prepared to work together to build a stronger public health infrastructure, ensure adequate training for emergency responders and other necessary personnel, and use new and existing technologies to combat future outbreaks. moreover, these authorities must understand the role of public health law. laws are essential to the empowerment, and restriction, of authorities to act in the interests of protecting the public's health prior to, during, and following a bioterrorism event. public health law provides the necessary authority for government to engage in public health activities. likewise, it limits government authority to infringe individual rights related to liberty, privacy, and property. many existing public health laws do not sufficiently clarify the contours or extent of public health powers. thus, legal reformation is needed to reflect modern conceptions of public health practice and contemporary constitutional norms. the msehpa and turning point act provide templates for public health law reform. these acts present clear criteria for governmental actions during public health emergencies. they delineate the scope of government public health power, the limits on this power, and the relationships between governments and other actors in emergency response situations. the roles of federal, state, and local governments in utilizing public health powers during public health emergencies must be considered and solidified in advance to avoid confusion or redundancy. public health authorities need to be able to implement a full range of strategies to combat the spread of infectious diseases through bioterrorism while respecting civil liberties. revision of state public health laws consistent with this balance will support and strengthen public health responses to future acts of bioterrorism. outbreak of severe acute respiratory syndrome -worldwide anthrax as a biological weapon shining a light on dark winter a plague on your city: observations from topoff biological threats and terrorism: assessing the science and response capabilities: workshop summaries trust for america's health. ready or not: protecting the public's health in the age of bioterrorism general accounting office. bioterrorism: federal research and preparedness activities model state emergency health powers act - (a) preventing the use of biological weapons: improving response should prevention fail the emerging threat of bioterrorism the looming threat of bioterrorism the specter of biological weapons what america needs to know to survive the coming bioterrorist catastrophe biological terrorism: legal measures for preventing catastrophe the national response plan: a new framework for homeland security, public health, and bioterrorism response anti-bioterrorism research post- / legislation: the usa patriot act and beyond catastrophe: risk and response defense against weapons of mass destruction act public health law: power, duty, restraint the law and the public's health: a study of infectious disease law in the united states public health law in an age of terrorism: rethinking individual rights and common goods the model state emergency health powers act the organizations include the national governors association (nga), the national conference of state legislatures (ncsl), the association of state and territorial health officials (astho), the national association of city and county health officers (nac-cho), and the national association of attorneys general (naag) bioterrorism law and policy: critical choices in public health msehpa state legislative activity table uniform emergency volunteer health practitioners act the resurgent tuberculosis epidemic in the era of aids: reflections on public health, law, and society rights and quarantine during the sars global health crisis: differentiated legal consciousness in hong kong, shanghai and toronto use of quarantine to prevent transmission of severe acute respiratory syndrome -taiwan efficiency of quarantine during an epidemic of severe acute respiratory syndrome -beijing large scale quarantine following biological terrorism in the united states center for disease control and prevention. legal authorities for isolation and quarantine center for disease control and prevention. division of global migration and quarantine: field operations executive order executive order (amending executive order to include ''influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause lessons from katrina: response, recovery, and the public health infrastructure the alphonse and gaston of governmental response to national public health emergencies: lessons learned from hurricane katrina for the federal government and the states the future of public health law aids and quarantine: the revival of an archaic doctrine ethical and legal challenges posed by severe acute respiratory syndrome: implications for the control of severe infectious disease threats confusion, controversy, and quarantine: the muncie smallpox epidemic of knocking out the cholera'': cholera, class, and quarantines a long pull, a strong pull, and all together'': san francisco and the bubonic plague searching eyes: privacy, the state, and disease surveillance in america when terrorism threatens health: how far are limitations on personal and economic liberties justified? key: cord- -p lijyu authors: rodriguez-proteau, rosita; grant, roberta l. title: toxicity evaluation and human health risk assessment of surface and ground water contaminated by recycled hazardous waste materials date: - - journal: water pollution doi: . /b sha: doc_id: cord_uid: p lijyu prior to the s, principles involving the fate and transport of hazardous chemicals from either hazardous waste spills or landfills into ground water and/or surface water were not fully understood. in addition, national guidance on proper waste disposal techniques was not well developed. as a result, there were many instances where hazardous waste was not disposed of properly, such as the love canal environmental pollution incident. this incident led to the passage of the resource conservation and recovery act (rcra) of . this act gave the united states environmental protection agency regulatory control of all stages of the hazardous waste management cycle. presently, numerous federal agencies provide guidance on methods and approaches used to evaluate potential health effects and assess risks from contaminated source media, i.e., soil, air, and water. these agencies also establish standards of exposure or health benchmark values in the different media, which are not expected to produce environmental or human health impacts. the risk assessment methodology is used by various regulatory agencies using the following steps: i) hazard identification; ii) dose-response (quantitative) assessment; iii) exposure assessment; iv) risk characterization. the overall objectives of risk assessment are to balance risks and benefits; to set target levels; to set priorities for program activities at regulatory agencies, industrial or commercial facilities, or environmental and consumer organizations; and to estimate residual risks and extent of risk reduction. the chapter will provide information on the concepts used in estimating risk and hazard due to exposure to ground and surface waters contaminated from the recycling of hazardous waste and/or hazardous waste materials for each of the steps in the risk assessment process. moreover, this chapter will provide examples of contaminated water exposure pathway calculations as well as provide information on current guidelines, databases, and resources such as current drinking water standards, health advisories, and ambient water quality criteria. finally, specific examples of contaminants released from recycled hazardous waste materials and case studies evaluating the human health effects due to contamination of ground and surface waters from recycled hazardous waste materials will be provided and discussed. after world war ii, industries began to produce a whole new generation of industrial and consumer goods made of synthetic organic chemicals such as plastics, solvents, detergents, and pesticides. industries profited enormously from the production and marketing of these products and consumers became accustomed to the convenience of synthetic products as well as cheap, convenient, throwaway packaging materials. as the industrial production of these products increased, so did the production, accumulation, and disposal of hazardous waste. prior to , facilities that handled and/or disposed of hazardous waste were not provided with detailed regulations and/or guidance on proper waste handling/ disposal techniques and, as a result, there were many instances where hazardous waste was improperly disposed. when chemicals are improperly disposed in the environment, abandoned hazardous waste sites are created that potentially affect human health and cost our society billions of dollars due to the high cost of not only evaluating human health and environmental impacts but also to performing site clean-ups. an example of one of the most well known incidents of improper disposal of hazardous waste was the love canal environmental pollution incident [ ] . this incident led to the passage of the resource conservation and recovery act (rcra) of . this act gave the united states environmental protection agency (usepa) regulatory control of all stages of the hazardous waste management cycle from the "cradle-to-grave:' beginning in the s, congress passed several other acts designed to protect human health and the environment ( table ) . based on the legislative directives in these acts, the usepa has issued numerous rules, regulations, and guidance documents that ensure that the use, disposal, processing, and handling of hazardous waste do not result in impacts to human health or the environment. state governments are authorized to implement these rules/regulations promulgated by the usepa, to permit facilities that handle hazardous waste in their states, and to create additional state rules and state regulations that apply to the operations of facilities in their specific state. the emphasis in recent years is to prevent pollution by recycling hazardous waste followed by proper disposal practices. rcra defines recyclable materials as "hazardous waste that are reclaimed to recover a usable product:' recycling is a broad term that applies to those who use, reuse, or reclaim waste to use as an ingredient to make a product and to use as an effective substitute for a commercial product. a material is reclaimed if it is processed to recover a useful by-product or forms the starting material for the systematic scientific approach of evaluating potential adverse health effects resulting from human exposure to hazardous agents or situations occur by the following steps: i) hazard identification; ii) dose-response (quantitative) assessment; iii) exposure assessment; iv) risk characterization [ ] . the overall objectives of risk assessment are to balance risks and benefits, to set target levels, to set priorities for program activities at regulatory agencies, industrial or commercial facilities, or environmental and consumer organizations, and to estimate residual risks and extent of risk reduction [ ] . diversity of risk assessment methodology helps ensure that all possible risk models and outcomes have been considered and minimize the potential for error [ ] . this section will provide information on the concepts used in estimating risk and hazard due to exposure to ground water and surface water contaminated from the recycling of hazardous waste and/or hazardous waste materials for each of the aforementioned steps. the first step in the risk assessment process is an evaluation of all human and animal data to determine what health effects occur after exposure to a chemical. well-conducted human studies are preferred, but occupational or accidental exposures to chemicals also provide useful information. however, in most cases, the results from animal studies are used as models to predict effects in humans since animal studies allow for controlled dose-response investigations and detailed, thorough toxicological analysis. some toxicants produce health effects immediately following exposure such as air pollutants that can produce eye irritation in individuals after a few minutes of exposure. other effects, such as organ damage due to metals and solvents, may not become manifested for months or years after first exposure. the time from the first exposure to the observation of a health effect is called the latent period. the length of this period is dependent on various factors such as the type of pathology induced by the compound/chemical of potential concern (copc), dose, dose rate as well as host characteristics such as age at first exposure, gender, race, species, and strain. other host factors that influence susceptibility to environmental exposures include genetic traits; preexisting diseases; behavioral traits such as smoking; coexisting exposures; and medication and vitamin supplementation [ ] . genetic studies include investigations of the effects of chemicals on the genes and chromosomes (genetic toxicology) and ecogenetics, a relatively new field, describes a host's genetic variation in predisposition and resistance to copc exposure [ ] . ecogenetics involves studies of specific exposures ranging from pharmaceuticals known as pharmacogenetics, pesticides, inhaled pollutants, foods, food additives, to allergic and sensitizing agents [ ] . moreover, induction of a health effect at the molecular level may occur after a single exposure, after repeated exposures, or after long-term continuous exposure. the length of the induction period may be a function of the same variables as the latent period. effective exposure time refers to the exposure time that occurred up to the point of induction [ ] . ineffective exposure is readily observed in dose-response curves as a saturation of response in the high dose range. an experimental study must follow the subjects beyond the length of the minimum latent period to observe all effects and cases associated with exposure. under ideal circumstances, a study will follow subjects for their lifetime. lifetime follow-up is common for animal studies but uncommon for epidemiology studies [ ] . qualitative assessment of hazard information should include a consideration of the consistency and concordance of the findings. such assessments should include a determination of the consistency of the toxicological findings across species and target organs, an evaluation of consistency across duplicate experimental conditions, and the adequacy of the experiments to detect the adverse endpoints of interest [ ] . for consideration of whether a copc is a carcinogen, qualitative assessment of animal or human evidence is done by many agencies, including the usepa and the international agency for research on cancer (iarc). similar evidence classifications are used for both animal and human evidence categories by both agencies. these evidence classifications are used for overall weight-of-evidence (woe) carcinogenicity classification schemes where the alphanumeric classification levels recommended by usepa [ ] are shown in table . usepa's woe carcinogenicity classification schemes were first recommended in the guidelines for carcinogen risk assessment (usepa, , hereafter " cancer table usepa's carcinogenicity classification scheme [ ] alphanumeric code evidence of noncarcinogenicity for humans; no evidence of carcinogenicity in adequate studies in at least two species or in both epidemiological and animal studies table weight-of-evidence classification scheme for qualitative assessment of chemical mixtures from mumtaz and durkin [ ] mechanistic understanding: i, ii, and iii i. direct and unambiguous mechanistic data ii. mechanistic data on related compounds iii. inadequate or ambiguous mechanistic data toxicologic significance: a, b, and c a. direct evidence of toxicologic significance of interaction b. probable evidence of a toxicologic significance based on related compounds c. unclear evidence of a toxicologic significance exposure modifiers: and . anticipated exposure duration and sequence . different exposure duration or sequence .a. in vivo data .b. in vitro data .b.i. anticipated route of exposure .b.ii. different route of exposure mixture is additive (=),greater than additive (> ), orless than additive ( <). guidelines") [ ] . however, the guidelines for carcinogen risk assessment, review draft (usepa, ,hereafter" draft cancer guidelines") [ ] recommend a woe narrative describing a summary of the key evidence for carcinogenicity. the draft cancer guidelines will serve as interim guidance until usepa issues final cancer guidelines [ ] . for evaluating chemical mixtures of noncarcinogens, mumtaz and durkin [ ] suggest the interaction data (i.e., independent joint action, similar joint action and synergistic action) and the qualitative and quantitative interaction matrix be taken into consideration when determining the hazard index. a qualitative woe scheme for evaluating chemical mixtures is shown in table . the woe takes into consideration the copc, data, reference doses/concentrations, and hazard index based on additivity [ ] . figure illustrates each of the chemical mixture's woe determination by a symbol indicating the direction of the interaction followed by the alphanumeric expression in table . the first two components are the major factors for ranking the quality of the mechanistic data to support the risk assessment. because toxicity studies must be evaluated to determine the quantitative dose-response relationship between the magnitude of exposure and the extent and severity of the adverse effect, a brief description of various toxicity tests will be provided. different methodologies are used to characterize doseresponse relationships, depending on whether or not the chemical has been identified as a carcinogen or noncarcinogen. carcinogens are assumed to pose some risk at any exposure level [ ] . four classes of toxicant-induced health effects include: i) cancer: genotoxic and nongenotoxic mechanisms; ii) hereditary effects: genotoxic mechanisms; iii) developmental effects: genatoxic or nongenotoxic mechanisms; iv) organ/tissue effects: nongenotoxic mechanisms [ ] . the evaluation of chemicals for acute toxicity is necessary for the protection of public health and the environment. acute toxicity is generally performed by the probable route of exposure in order to provide information on health hazards likely to arise from short-term exposure by that route (table ) [ ] . as shown in table , there are four categories ranging from i to iv based on increasing doses. generally, acute studies evaluate oral, dermal, inhalation, and eye and skin irritation as well as dermal sensitization. the acute inhalation studies are performed from one to seven days while the intermediate studies are performed from seven days to several months [ ] .an evaluation of acute toxicity data includes the relationship of the exposure to the copc and the incidence and severity of all abnormalities, gross lesions, body weight changes, effects on mortality, and any other toxic effects. an acute exposure is considered to be a one-time or short-term exposure with a duration of less than or equal to h. acute toxicity testing is conducted toxity evaluation and human health risk assessment of surface and ground water up to days of exposure and subacute testing for - days. testing periods for the evaluation of developmental effects is less than days since developmental toxicity can occur after short periods of exposure. sub chronic testing is typically conducted for days to year since subchronic exposures are considered to be multiple or continuous exposures occurring for approximately % of an experimental species lifetime. chronic exposures are assumed to be multiple exposures occurring over an extended period of time, or a significant fraction of the animal's or the individual's lifetime. to minimize the number of animals used and to take full account of their welfare, usepa recommends the use of data from structurally related substances or mixtures [ ] . review of existing toxicity information on chemical substances that are structurally related to the copc may provide enough information to make preliminary hazard evaluations that may reduce the need for testing. for example, if a chemical can be predicted to have corrosive potential based on structure-activity relationships (sars), dermal or eye irritation testing does not need to be performed in order to classify it as a corrosive agent. all the human carcinogens that have been identified have produced positive results in at least one animal model. in the absence of adequate human data, it is plausible to regard agents and/or mixtures for which sufficient evidence of carcinogenicity in animals exists to be a possible carcinogenic risk to humans [ ] . therefore, chemicals that cause tumors in animals are presumed to cause tumors in humans. in general, the most appropriate rodent bioassays are those that test the exposure pathways most relevant to human exposure pathways, i.e., inhalation, oral, dermal, etc. because it is feasible to combine bioassays together, it is desirable to tie these bioassays with mechanistic studies, biomarker studies, and genetic studies to understand the mechanism(s) of toxicity and/or carcinogenicity [ ] . a typical experimental design includes two different species, both genders, at least subjects per experimental group using near lifetime exposures. for dose-response purposes, a minimum of three dose levels should be used. the highest dose, typically the maximum tolerated dose, mtd, is based on the findings from a -day study to ensure that the test dose is adequate for the assessment of chronic toxicity and carcinogenic potential. the lowest dose level should produce no evidence of toxicity. in the oral studies, the animals are dosed with the copc on a -day per week basis for a period of at least months for mice and hamsters and months for rats [ ] . for dermal studies, animals are treated with the copc for at least h per day on a -day per week basis for a period. a minimum of h should be allowed for the skin to recover before the next dosing. the copc is applied uniformly over a shaved area that is approximately % of the total body surface area [ ] . the animals are evaluated for an increase in number of tumors, size of tumors, and number of rare tumors seen and/or expressed. even without toxicity, a high dose may trigger events different from those triggered by low-dose exposures. also, these bioassays can be evaluated for uncontrolled effects by comparing weight vs time and mortality vs time curves [ ] . if there is a divergence between the control group and the experimental group in the weight vs time curve, this indicates that there is a disruption of normal homeostasis due to high-level dosing. if there is a divergence in the mortality vs time curves, this indicates that there is an uncontrollable effect [ ] . the national toxicology program (ntp) criterion for classifying a chemical as a carcinogen is that it must be tumorigenic in at least one site in one sex of f rats or b c f mice. validation and application of short-term tests (stt) are important in risk assessment because these assays can be designed to provide information about mechanisms of effects. short-term toxicity experiments includes in vitro or short-term in vivo tests ranging from bacterial mutation assays to more elaborate in vivo short-term tests such as skin-painting studies in mice and altered rat liver foci assays. these studies determine if copcs are mutagenic, indicating they have the potential to be carcinogens as well. in general, stt are fast and inexpensive compared with the lifetime rodent cancer bioassays [ ] . positive results of stt have been used to predict potential carcinogenicity. common stt include the following: ames salmonella/microsome mutagenesis assay (sal); assays for chromosome aberration (abs); sister chromatid exchange induction (sce) in chinese hamster ovary cells; the mouse lymphoma l y cell mutagenesis assay (moly). there are several limitations to stt such as: stt cannot replace long-term rodent studies for the identification of carcinogens; the available tests do not detect all classes of copcs that are active in the carcinogenic process such as hormones; and negative results from stt cannot rule out carcinogenicity [ ] . the most convincing evidence for human risk is a well-conducted epidemiological study where an association between exposure to copc and a disease has been observed. these studies compare copc-exposed individuals vs non-copc-exposed individuals [ ] . the major types of epidemiology studies are cross-sectional studies, cohort studies, and case-control studies. cross-sectional studies survey groups of humans to identify risk factors and disease. these studies are not very useful for establishing a cause-and-effect relationship. cohort studies evaluate individuals on the basis of their exposure to the copc under investigation. these individuals are monitored for development of disease. prospective studies monitor individuals who initially are diseasefree to determine if they develop the disease over time. in case-control studies, subjects are selected on the basis of disease status and are matched accordingly. the exposure histories of the two groups are compared to determine key consistent features. thus, all case-control studies are retrospective studies [ ] . epidemiological findings are evaluated by the strength of association, consistency of observations, specificity, appropriateness of temporal relationship, dose responsiveness, biological plausibility and coherence, verification, and biological analogy [s].a disadvantage of epidemiological studies is an accurate measure of concentration or dose that the copc-exposed individuals receives is not available, so estimates must be employed to quantify the relationship between exposure and adverse effects. moreover, the control group is a major determinant of whether or not a statistically significant adverse effect can be detected. the various types of control groups are: regional general population; general population of a state; local general population; and workers in the same or a similar industry who are exposed to lower or zero levels of the toxicant under study [ ] . dose-response assessment is the fundamental basis of the quantitative relationship between exposure to an agent and the incidence of an adverse response. the procedures used to define the dose-response relationship for carcinogens and noncarcinogens differ. for carcinogens, a non-threshold, zero threshold, dose-response relationship is used when there are known or assumed risks of an adverse response at any dose above zero. non-threshold toxicants include hereditary disease toxicants, genotoxic carcinogens, and genotoxic developmental toxicants. for noncarcinogens, a threshold, nonzero threshold is used to evaluate toxicants that are known or assumed to produce no adverse effects below a certain dose or dose rate. threshold toxicants include nongenotoxic carcinogens, nongenotoxic developmental toxicants, and organ/ tissue toxicants [ ] . the two different approaches will be discussed separately in this section. the toxicity factors used to evaluate oral exposure and inhalation exposure are expressed in different units to account for the unique differences between these two routes of exposure. cancer slope factors (csfs), in units of (mg/kg/day)-t, and reference doses (rids), in units of mg/kg/day, are used to quantify the relationship between dose and effect for oral exposure whereas unit risk factors (urfs), in units of (jlg/m )-t, and reference concentrations (rfcs), in units of mg/m\ are used to describe the relationship between ambient air concentration and effect for inhalation exposure. the urf and rfc methodology accounts for the species-specific relationships of exposure concentration to deposited/delivered doses to the respiratory tract by employing animal-to-human dosimetric adjustments that are different than those employed for oral exposure. the interaction with the respiratory tract and ultimate disposition are considered as well as the physicochemical characteristics of the inhaled agent and whether the exposure is to particles or gases. most important is the type of toxicity observed since direct effects on the respiratory tract (i.e., portal of entry effects) must be considered as opposed to toxicity remote to the portal-of-entry [ ] . based on the differences between oral and inhalation exposure, route to route extrapolation of oral toxicity values to inhalation toxicity values may not be appropriate. please refer to appendix b of the soil screening guidance [ ] for a discussion of issues relating to route-to-route extrapolation. carcinogenic assessment assumes that exposure to any amount of a carcinogenic substance increases carcinogenic risk. thus, zero risk does not exist (a non-threshold response) because there is no carcinogen exposure concentration low enough that will not increase risk of cancer. a genotoxic carcinogen alters the information coded in dna; thus, it is reasonable to assume that these agents do not have a threshold so that a risk of cancer exists no matter how low the dose. there are three stages of genotoxic carcinogenesis: initiation, promotion, and progression. initiation refers to the induction of an irreversible change in dna caused by a mutagen. the initiator may be a direct-activating carcinogen or a carcinogenic metabolite. promotion refers to the possibly reversible replication of initiated cells to form a "benign" lesion. promoters are not genotoxic or carcinogenic but they enhance the tumorigenic response initiated by a primary or secondary carcinogen when administered at a later time. complete carcinogens have initiation and promotion properties [ ] . nongenotoxic carcinogenesis does not involve direct interaction of a carcinogen with dna. mechanisms of nongenotoxic carcinogenesis include an accelerated replication that may increase the frequency of spontaneous mutations or increase the susceptibility of dna damage. cancer may be secondary to organ toxicity and may occur only at high dose rates. moreover, many nongenotoxic cancer mechanisms are species-specific where the results from certain rodent species may not apply to human [ ] . several approaches and models are used to provide estimates of the upper limit on lifetime cancer risks per unit of dose or unit of ambient air concentration, i.e., the csf or the urf, respectively. the upper bound excess cancer risk estimates may be calculated using models such as the one-hit, weibull, logit, log-probit,or multistage models [ , ] . the linearized multistage model is considered to be one of the more conservative models and is typically used because the mechanism of cancer is not well understood and one model may not be more predictive than another one [ , ] . because the risk assessor generally needs to extrapolate beyond the region of the dose-response curve for which experimentally observed data are available, models derived from mechanistic assumptions involve the use of a mathematical equation to describe dose-response relationships that are consistent with biological mechanisms of response [ ] . "hit models" for cancer modeling assume that i) an infinite number of targets exist, ii) after a minimum of targets have been modified, the host will elicit a toxic response, iii) a critical target is altered if a sufficient number of hits occurs, and iv) the probability of a hit in the lowdose range is proportional to the dose of copc [ ] . the one-hit linear model is the simplest mechanistic model where only one hit or critical cellular interaction is required for cell function to be altered. multi-hit models describe hypothesized single-target multi-hit events as well as multi-target events in carcinogenesis. biologically based dose-response (bbdr) modeling reflects specific biological process [ ] . because a large number of subjects would be required to detect small responses at very low doses, several theoretical mathematical extrapolation models have been proposed for relating dose and response in the subexperimental dose range: tolerance distribution models, mechanistic models, and enhanced models. these mathematical models generally extrapolate low-dose carcinogenic risks to humans based on effects observed at the high doses in experimental animal studies. the linear interpolation model interpolates between the response observed at the lowest experimental dose and the origin. linear interpolation is recommended due to its conservatism, simplicity, and reliance because it is unlikely to underestimate the true-low dose risk [ ] . there is no universally agreed upon method for estimating an equivalent human dose from an animal study. however, several methods are currently being used to obtain an estimate of the equivalent human dose. the first method calculates an equivalent human dose from an animal study by scaling the animal dose rate for animal body weight. to derive an equivalent human dose from animal data, the draft cancer guidelines recommend adjusting the daily applied oral doses experienced over a lifetime in proportion to bw [ ] . for noncarcinogens, an uncertainty factor is employed to estimate the equivalent human dose from an animal study if pharmacokinetic data is not available. noncarcinogenic dose-response assessment utilizes a point of effects method which selects the highest dosage level tested in humans or animals at which no adverse effects were demonstrated and applies uncertainty factors or margins of safety to this dosage level to determine the level of exposure where no health effects will be observed, even for sensitive members of the population. also, benchmark dose modeling may be conducted if the experimental data are adequate. animal bioassay data are generally used for dose-response assessment; however, the risk assessor is normally interested in low environmental exposures of humans, which are generally below the experimentally observable range of responses seen in the animal assays. thus, low-dose extrapolation and animal-to-human risk extrapolation methods are required and constitute major aspects of dose-response assessment. human and animal dose rates are frequently reported in terms of the following abbreviations, which are defined below: loel lowest observed effect level in mglkg·day, which produces a statistically or biologically significant effect loael lowest observed adverse effect level in mg/kg·day, which produces a statistically or biologically significant adverse effect noel no observed effect level in mg/kg·day, which does not produce a statistically or biologically significant effect noael no observed adverse effect level in mg!kg·day, which does not produce a statistically or biologically significant adverse effect. key factors in determining which noael or loael to use in calculating a reference dose (rid) is exposure duration. as mentioned previously, acute animal studies are typically conducted for up to days, subacute studies for to days, and subchronic studies for days to year. chronic studies are conducted for a significant portion of the lifetime of the animal. animals may experience health effects during short-term exposure which may differ from effects observed after long-term exposure, so short-term animal studies less than days should not be used to develop chronic rids except for the development of interim rids or developmental rids. exceptionally high quality > day oral exposure studies may be used as a basis for developing an rid whereas the inhalation route is preferred for deriving a rfc [ ] . please note that the same approaches used to develop the rid are used to develop the rfc, the only difference being the route of exposure, animal-to-human dosimetric adjustments, and the units, (i.e., mg/m for the rfc vs mg/kg/day for the rid). the highest dose level that does not produce a significantly elevated increase in an adverse response is the noael. the noael from the critical study should be used for criteria development, i.e., the health effect that occurs at the lowest dose. however, if a noael is not available, then the loael can be used if a loael to noael uncertainty factor (uf) is applied. significance generally refers to both biological and statistical criteria and is dependent on the number of dose levels tested, the number of animals tested at each dose, and the background incidence of the adverse response in the control groups [ ] . noaels can be used as a basis for risk assessment calculations such as rids and acceptable daily intake values (adi). adi and rid values should be viewed as a conservative estimate of levels below which adverse affects would not be expected; exposures at doses greater than the adi or rid are associated with an increase probability (but not certainty) of adverse effects [ ] . who uses adi values for pesticides and food additives to define "the daily intake of chemical, which during an entire lifetime appears to be without appreciable risk on the basis of all known facts at that time" [ ] . in order to remove the value judgments implied by the words "acceptable" and "safety", the adi and safety factor (sf) terms have been replaced with the terms rid and up/modifying factors (mf), respectively. usepa publishes rids and rfcs in either iris or in the usepa's health effects assessment summary tables (heast) . rids and adi values (eqs. and , respectively) are typically calculated from noael values divided by the uf and/or mf: the uncertainty factor (uf) may range from to , depending on the nature and quality of the data and is determined by multiplying different ufs together to account for five areas of scientific uncertainty [ ] . the uf is primarily used to account for a potential difference between the animal's and human's sensitivity to a particular compound. the ufh and uf a accounts for possible intraand interspecies differences, respectively. as mentioned previously, an ufs is used to extrapolate from a subchronic duration study to a situation more relevant for chronic study and an ufl is used to extrapolate from a loael to a noael. an uf is used to account for inadequate numbers of animals, incomplete databases, or other experimental limitations. a modifying factor (mf} can be used to account for additional scientific uncertainties. in general, the magnitude of the individual ufs is assigned a value of one, three, or ten, depending on the quality of the studies used in developing the rid or rfc. this uf is reduced whenever there is experimental evidence of concordance between animal and human pharmacokinetics and when the mechanism of toxicity has been established. recently, benchmark dose modeling has been recommended by usepa instead of the noael approach. criticism of the noael approach exists because of its limitations, which include the following: i) the noael must be one of the experimental doses tested; ii) once the dose is identified, the remaining doses are irrelevant; iii) larger noaels may occur in experiments with few animals thereby resulting in larger rids; iv) the noael approach does not identify the actual responses at the noael and will vary based on experimental design. these limitations of the noael approach resulted in the benchmark dose (bmd) method [ ] . the dose-response is modeled and the lower confidence bound for a dose (bmdl) at a specified response level, benchmark response (bmr), is calculated [ ] . the bmdlx (with x representing the x percent bmr) is used as an alternative to the noael value for the rid calculations. thus, the calculation of the rid is shown in eq. ( }: advantages of the bmd approach includes: i) the ability to account for the full dose-response curve; ii) the inclusion of a measure of variability; iii) the use of responses within the experimental range; iv) the use of a consistent benchmark response level for rid calculations across studies [ ] . there are numerous informational databases or resources that provide risk assessors essential information. usepa publishes rids, rfcs, csfs, and urfs in the integrated risk information system (iris) or in the health effects assessment summary tables (heast). the information in iris followed by heast should be used preferentially before all other sources. a recent review of other available resources was published in a special volume of toxicology, vol , . articles by poore et al. [ ] and brinkhuis [ ] provide a thorough review of u.s. government databases such as usepa's iris at http://www.epa.gov/ iriswebp/iris/, national center for environmental assessment (ncea),atsdr's chemical-specific toxicology profiles and acute, subchronic, and chronic minimal risk levels (mrls ), and hazdat at http:/ /www.atsdr.cdc.gov/hazdat.html, among many other databases. the reviewers provide advise for effective search strategies as well as strategies for finding the appropriate toxicology information resources. exposure occurs when a human contacts a chemical or physical agent. exposure assessment examines a wide range of exposure parameters pertaining to the environmental scenarios of people who may be exposed to the agent under study. the information considered for the exposure assessment includes monitoring studies of chemical concentration in environmental media and/or food; modeling of environmental fate and transport of contaminants; and information on different activity patterns of different population subgroups. the principal pathways by which exposure occurs, the pattern of exposure, the determination of copc intake by each pathway, as well as the number of persons and whether there are sensitive subpopulations that need to be evaluated are also included in the evaluation. in this step, the assessor characterizes the exposure setting with respect to the general physical characteristics of the site, the site copcs, and the characteristics of the populations on or near the site. hazard identification/evaluation consists of sampling and analysis of soil, ground water, surface water, air, and other environmental media at contaminated sites. a common method used in screening substances at a site is by comparison with background levels in soil or ground/ surface water [ ] , determining if a chemical is detected or not and whether the detection limit for that chemical is less than reference concentrations as well as frequency of detection [ ] . once a list of copcs have been identified at the site, the availability of chemical characteristics such as struc-ture, solubility, stability, ph sensitivity, electrophilicity, and chemical reactivity and toxicity data are collected and evaluated to ascertain the nature of health effects associated with exposure to these chemicals. in many cases, toxicity information on chemicals is limited. knowing the copc's characteristics can represent important information for hazard identification [s] .also, sars are useful in assessing the relative toxicity of chemically related compounds. during this phase of exposure assessment, the major pathways by which the previously identified populations may be exposed are identified. therefore, locations of contaminated media, sources of release, fate and transport of copcs, pathways and exposure points, routes of exposure (i.e., ingestion of drinking water, dermal contact when showering) and location and activities of the potentially exposed population are explored. for example, the common on-site pathways evaluated when conducting a rcra remediation baseline risk assessment where unauthorized chemical releases have occurred includes direct contact with soil either by ingestion of soil and/ or inhalation of volatile chemicals or contaminated dust [ ] . the migration of chemicals off-site can occur via wind-blown dust and vapor emissions from soil, leaching of chemicals to ground water with subsequent movement off-site, and run-off surface water. these off-site chemicals can eventually accumulate in other transport media such that the copc ends up in vegetation crops, meat, milk, and fish that will eventually be consumed by humans. therefore, pathways, sources of release, locations of contaminated media, fate and transport of copcs, and location and activities of the potentially exposed population are explored. exposure points and routes of exposure (ingestion, inhalation) are identified for each exposure pathway. it is necessary to identify populations likely to receive especially high exposure and populations likely to be unusually sensitive to the chemical's effects. an example of possible point of exposures and exposure routes due to exposure to ground water or surface water (i.e., source medium) used for drinking water is shown in table . please note that all of these exposure path- volatilization from water air inhalation into enclosed space ways are typically not evaluated when doing a risk assessment on contaminated drinking water since the techniques and exposure parameters for evaluating these routes of exposure are not well developed. additional pathways to consider for surface water may include recreational exposures (i.e., swimming, boating), ingestion of contaminated fish, shellfish, etc., and dermal exposure to contaminated sediment. finally, an attempt should be made to develop a number of exposure scenarios. exposure scenarios are a combination of"exposure pathways" to which a single "receptor" may be subjected [ ] . for example, a residential adult or child receptor may be exposed to all the exposure routes in table (i.e., drinking water, showering/bathing, washing/cooking food, and volatilization from ground water or drinking water into an enclosed space). an industrial receptor may only be exposed through the drinking water pathway and volatilization from ground water into an enclosed space and not be exposed through showering/bathing or washing/ cooking, because these activities are not allowed at an industrial site. exposure scenarios are generally conservative and not intended to be entirely representative of actual scenarios at all sites. the scenarios allow for standardized and reproducible evaluation of risks across most sites and land use areas [ ] . conservatism allows for protection of potential receptors not directly evaluated such as special subpopulations and regionally specific land uses. the magnitude, frequency and duration of exposure for each pathway are next evaluated. for each potential exposure pathway, the chemical doses received by each exposure route needs to be calculated. because chemical concentrations can vary, many different studies might be required to get a complete picture of the chemical's distribution patterns within the environment. off-site sampling and analysis are preferred methods to determine the exposure concentrations in the environmental media at the point of exposure. because sampling data forms the foundation of a risk assessment, it is important that site investigation activities are designed and implemented with the overall goals of the risk assessment to be performed [ ] . for example, it is essential that appropriate analytical methods with proper quality assurance/quality control documentation be employed and that the analytical methods are sensitive enough to detect the copc at concentrations that are below health protective reference concentrations. after the sampling data is collected and evaluated, then statistical techniques may be used to calculate the representative concentration of copcs that will be contacted over the exposure area. different statistical techniques may be required for the determination of representative concentrations in ground water vs surface water [ ] . fate and transport models can be used to estimate current concentrations in media and/or at locations for which sampling was not conducted. in addition, an increase in future chemical concentrations in media that are currently contaminated or that may become contaminated can be predicted by fate and transport modeling. detailed discussions of these models are contained elsewhere in this book. each scenario described in the exposure assessment should be accompanied by an estimated exposure dose for each pathway. once the exposure pathway is determined, then the estimated risks and hazards from each exposure pathway can be characterized. exposure estimates for the oral pathway are expressed in terms of the mass of substance in contact with the body per unit body weight per unit time (i.e., intakes) whereas exposure estimates from inhalation pathways are expressed as mass of substance per unit volume (i.e., inhalation concentrations). the general equation for calculating intakes (mg/kg/day) is as follows [ ] : intake, the amount of chemical at the exchange boundary (mg/kg body weight-day) c copc concentration, average concentration contacted over the exposure period cr contact rate, the amount of contaminated medium contacted per unit time or event ef exposure frequency (days/year) ed exposure duration (years) bw body weight, the average body weight over the exposure period (kg) at averaging time or period over which exposure is averaged (days). each exposure pathway has slightly different variations of the above basic equation. please refer to appendix a for examples of equations used to calculate intakes for the major exposure pathway from ground and surface waters as well as examples of exposure parameters employed to calculate intakes: appendices a- and a- , ingestion of drinking water; appendices a- and a- , ingestion of contaminated fish tissue; appendices a- and a- , dermal contact with contaminated water; and appendix a- inhalation of volatiles from contaminated ground water or surface water. please refer to kasting and robinson [ ] and exposure to contaminants in drinking water [ ] for additional information on the various issues involved in the assessment of dermal exposure to water. the exposure parameters (e.g., cr, ef, ed, bw, and at) for each pathway are derived after an extensive literature review and statistical analysis [ ] . for example, information on water ingestion rates, body weights, and fish ingestion rates for adults, children, and pregnant women used to develop the national ambient water quality criteria were obtained from the following documents: exposure factors handbook [ ]; national health and nutrition examination survey (nhanes iii) [ ] ; and united states department of agriculture (usda) - continuing survey of food intakes [ ] . exposure parameters may represent central tendency or average values or maximum or near-maximum values [ ] . science policy decisions that consider the best available data and risk management judgments regarding the population to be protected are both used to choose appropriate exposure parameters. usepa emphasizes that exposure assessments should strive to achieve an overall dose estimate that represents a "reasonable maximum exposure (rme):' the intent of the rme is to estimate a conservative exposure scenario that is within the range of possible exposures yet well above the average case (above the h percentile of the actual distribution). however, estimates that are beyond the true distribution should be avoided. if near maximum or maximum values are chosen for each exposure parameter, then the combination of all maximum values for each exposure parameter would result in an unrealistic assessment of exposure. using probabilistic risk assessment, cullen demonstrated that if only two exposure parameters were chosen at maximum or near maximum values, and other parameters were chosen at medium values, than the risk and hazards estimates represented a rme (> % percentile level) [ ] . risk assessors should identify the most sensitive parameters and use maximum or near-maximum values for one or a few of those variables. central tendency or average values should be used for all other parameters [ ] . when central tendency and/or maximum values are chosen for exposure parameters used to calculate intake for an exposure pathway, single point estimates of risk and hazard are calculated (i.e., a deterministic technique). however, probabilistic techniques like monte carlo analysis can be employed to provide different percentile estimates of risk and hazard (i.e., soth percentile or th percentile estimates) as well as to characterize variability and uncertainty in the risk assessment. monte carlo simulation is a statistical technique by which a quantity is calculated repeatedly, using randomly selected values from the entire frequency distribution for an exposure parameter or multiple exposure parameters for each calculation. usepa recommends using computerized monte carlo simulations to provide probability distributions for dose and risk estimates by incorporating ranges for individual assumptions rather than a single dose or risk estimate [ ] . using better estimates for the distribution of contaminant levels is a major focus of recent risk assessment research. to obtain such estimates, several techniques, such as generating subjective uncertainty distributions and monte carlo composite analyses of parameter uncertainty, have been applied [ ] . these are approaches that can provide a reality check that is useful in generating more realistic exposure estimates [ ] . also, high-end exposure estimates (heees) and theoretical upper-bound estimates (tubes) are now recommended for specified populations as well as calculation of exposure for highly exposed individuals [ ] . heee represents an estimate of the exposure in the upper ninetieth percentile while tubes represent exposure levels that exceed exposures experienced by all individuals in the exposure distribution and assume limits for all exposure variables [ ] . please refer to the policy for use of probabilistic analysis in risk assessment at the usepa and guiding principles for monte carlo analysis at http:/ /www.epa.gov/ ncea/mcpolicy.htm [ ] . risk characterization, the last step in the risk assessment process, links the toxicity evaluation (hazard identification and dose-response assessment) to the exposure assessment. estimates of the upper-bound excess lifetime cancer risk and noncarcinogenic hazard for each pathway, each copc, and each receptor identified during the exposure assessment are calculated. another important component of risk characterization is the clear, transparent communication of risk and hazard estimates as well as an uncertainty analysis of those estimates to the risk manager. cancer risk is usually expressed as an estimated rate of excess cancers in a population exposed to a copc for a lifetime or portion of a lifetime [ ] . oral intakes are multiplied by the csf (eq. ), dermal intakes are multiplied by the csf adjusted for gi absorption (eq. ), and lifetime average inhalation concentrations are multiplied by the urf (eq. ) to obtain risk estimates. for evaluating the risk from oral exposure, the intakes from all ingestion pathways can be summed (i.e., ingestion of drinking water, ingestion of fish, etc.), then the total intake is multiplied by the csf, as follows: ( ) intakeoral the combined amount of copc from all oral pathways at the exchange boundary (mg/kg/day) (appendices a- to a- ) csf cancer slope factor (mg/kg/day)- • for evaluating dermal exposure, the dermally absorbed dose (dad) is calculated (appendices a- and a- ) and multiplied by an adjusted csf, csf dermal· the csf is typically derived based on oral dose-response relationships that are based on administered dose, whereas the dermal intake estimates are based on absorbed dose. therefore, if the csf is based on an administered dose, it should be adjusted for gastrointestinal absorption, if gastrointestinal absorption is significantly less than % (e.g., < %) [ ] . therefore, if an estimate of the gastrointestinal absorption fraction (absgi) is available for the compound and absgi is less than % [ , ] , then the oral dose-response factor, based on an administered dose, can be converted to an absorbed dose basis by dividing the csf by the absgr to form a csf derma!: where dad dermally absorbed dose (mg/kg/day) (appendices a- and a- ) ( ) csfdermal dermal cancer slope factor (mg/kg/day)- ; csfdermat=(csf/absg ). when absgr values are not available from bast and borges [ ] for a compound, then usepa region [ ] recommends the following defaults for absg : % for volatile organics; % for semi-volatile organics and nonvolatile organics; and % for inorganics. for evaluation of inhalation exposure, the lifetime average inhalation concentration is multiplied by the urf: where cinh concentration of copc at the exchange boundary (mg/m ) (appendix a- ) urf unit risk factor (jlg/m )- • to obtain a conservative total risk estimate, the risks for an individual copc from each pathway is summed and then the risks from all copcs are summed (eq. ): where ( ) rtotal sum of all risk estimates from all i h copcs from all pathways. however, usepa is still developing approaches to deal with the uncertainties associated with combining risk estimates of chemical mixtures across different routes of exposure (i.e., inhalation, oral, and dermal) since differences in the properties of the cells that line the surfaces of the air pathways and the lungs, the gastrointestinal tract and the skin may result in different intake patterns of chemical mixtures components depending on the route of exposure. another consideration in dealing with chemical mixtures is the chemicals in a mixture may partition to contact media differently [ ] .a risk estimate of x , x , or x is interpreted to mean that an individual has not more than, and likely less than, a in , , , in , , or in , chance, respectively, of developing cancer from the exposure being evaluated. the range of carcinogenic risks acceptable by the usepa is iq- to iq- • for chronic exposures to noncarcinogens, the intake of a copc is compared to the appropriate rid (i.e., oral rid or rid dermal) or rfc to form the hazard quotient (hq) [ ] . oral intakes are compared to the rid (eq. ), dermally absorbed doses (dads) are compared to the rid dermal (i.e., rid adjusted for gi absorption refer to the previous section for a discussion of procedures for adjusting toxicity factors for gi absorption) (eq. ), and inhalation intakes are compared to the rfc (eq. ) to obtained hazard quotients for each route of exposure: l intakeoral hqoral = rjd ( ) where intakeoral the combined amount of copc from all oral pathways at the exchange boundary (mg/kg/day) (appendices a- to a- ) rid oral reference dose (mg/kg/day) the total hazard index (hi) for an individual copc from all routes of exposure is the sum of the hqs from all applicable pathways (oral, dermal, or inhalation) (eq. ): hi; = l hq; ( ) where hii the sum of the hazard quotients from all relevant pathway for the i h co pc. in order to be conservative, a total hi can be calculated by summing the his from each individual copc. "if the overall hi value is less than one, public health risk is considered to be very low"; however, "if the hi value is equal to or greater than one, then the exposure assessment and hazard characterization should be investigated more thoroughly:' if the hi exceeds one, then the hazard estimates may be refined by grouping the copcs that affect the same target organ or have the same mechanism of action and adding only the his from similar-acting copcs [ , ] . ideally, chemicals would be grouped according to effect-specific toxicity criteria, information on chemicals exhibiting multiple effects would be available, and their exact mechanism of action would be known. instead, rids and rfcs are available for just one of the several possible endpoints of toxicity for a chemical and data are often limited to gross toxicological effects in an organ or an entire organ system. the list of these specific endpoints of toxicity is limited so it is best to consult a toxicologist during this step of the hazard evaluation [ ] . each copc and exposure pathway needs to be calculated to determine the actual risk. the hi provides a rough estimate of possible toxicity and requires careful interpretation [ ] . the hi does not account for the number of individuals who might be affected by exposure or the severity of the effects. usepa recommends that a hi of . be used for noncancer health effects. in the "real world", exposures generally involve complex mixtures of copcs. there are three basic actions for mixtures: i) independent joint action, which describes copcs that act independently and have different modes of action and are not expected to affect the toxicity of one another; ii) similar joint action or "dose addition;' which describes a mixture where the copcs produce similar but independent effects; iii) synergistic action, which the effective mixture cannot be assessed from the individual ingredients but depends on knowledge of their combined toxicity [ ] (table and fig. ). the total hi can exceed the target hazard level as a result of the presence of either one or more copcs with an hq exceeding the target hazard level or the summation of several copc-specific hqs that are each less than the target hazard level. it is important to mention that the numbers generated by risk assessors should not be viewed as either accurate measures or even predictors of rates of adverse health effects in human populations [ ] . the calculated estimates are routinely based on assumptions recognized as being conservative. thus, these numbers should be used as tools open to interpretation on a site-by-site basis. it is important for the risk manager to be informed of the uncertainties during the risk assessment process. significant limitations and uncertainties can exist throughout the entire risk assessment process; thus, it is important that a discussion of uncertainty accompanies risk assessment analysis so that the limitations of the quantitative results are taken into consideration. both qualitative and quantitative methods have been developed to analyze the uncertainty associated with risk assessment. a quantitative analysis may be conducted using either a sensitivity analysis or a probability analysis. listed below are the various reasons why uncertainty exists in a risk assessment analysis [ , ] : -deficient control groups -difference in smoking habits between an epidemiology study group and a risk group -differences or lack of consideration of pharmacokinetics and/or mechanism of toxicity between species -failure to diagnose or misdiagnosis the cause of mortality -inappropriate experimental study design -lack of knowledge regarding combined biological effects of exposure to multiple toxicants -limitation in data regarding nature and magnitude of levels in the environment -low-dose extrapolation from high-dose experimental conditions -reliance on mathematical models -toxicant interaction with another agent -use of animal studies in the determination of risk for humans it is important to make clear the distinction between risk assessors and risk management. risk assessors generate risk estimates but a risk manager considers these risk estimates, other scientific information, and integrates it into societal decisions [ ] . for example, risk managers consider data analysis, technical concerns, economic concerns, and social/political concerns in addition to comparing the risk estimates to an acceptable level set by federal or state health agencies [ ] . generally, trade-offs or compromises are made for the lowest possible risk and society's demand for jobs and economic growth. examples of questions that may be asked by risk managers are: "is a particularly deadly type of cancer in a narrow population worse or better than widespread effects of a non-lethal nature? can this decision be successfully defended in court?" in general, risk management decisions may be based more on political and economic factors than risk factors [ ] . risk assessment and risk management are an integral part of the contemporary regulatory scene. risk management refers to the selections and implementation of the most appropriate regulatory action based on: i) goals; ii) social and political factors; iii) available control technology; iv) costs and benefits; v) results of risk assessment; vi) acceptable risk; vii) acceptable number of cases [ ] . another aspect to consider is cumulative risk in either the risk assessment or risk management phase. cumulative risk evaluation considers all "involuntary" risk to which a receptor may be exposed by a variety of environmental risks such as: i) automobile exhaust emissions; ii) leaking underground storage tanks; iii) untreated sewage; iv) agricultural land runoff; v) industrial process air emissions; vi) conventional combustion-related air emissions [ ] . however, at the present time, definite guidance from usepa regarding the evaluation of cumulative risk is not available. a refined site-specific risk assessment takes into account the specific characteristics concerning the site, all relevant pathways a receptor is exposed to, and other site-specific information. this represents a "forward" calculation method where risk and hazard estimates are calculated. however, each state or usepa regional office may utilize slightly different exposure factors, exposure scenarios, target risk and hazard levels or different procedures to account for childhood exposure, cumulative risk, etc. it is a very time-and resource-intensive process, which involves numerous scientific policy decisions. however, risk and hazard estimates from a refined site-specific risk assessment typically provide more realistic estimates than a generic screening level risk assessment. in contrast, media-specific comparison values can be calculated based on a "backward" calculation method based on standardized equations, usepa toxicity values, standard exposure pathways or scenarios, default exposure factors, and conservative risk and hazard levels. usepa office of water has derived drinking water standards and health advisories to evaluate levels of contaminants in public drinking water supplies. to evaluate levels of contaminants in surface water, usepa publishes guidance documents [ ] as well as national recommended water quality criteria. state and tribal agencies then develop water quality standards for each water body in the state based on usepa guidance and the use designation for the individual water body. usepa must review the proposed state water quality standards before they become legally enforceable standards. if drinking water standards and/ or state and tribal water quality standards are available for the copcs present at the site, these standards generally must be used to evaluate human health impacts to groundwater and/or surface water, respectively. water quality standards apply to surface waters of the united states, including rivers, streams, lakes, oceans, estuaries, and wetlands. water quality standards consist, at a minimum, of three elements: ) the "designated beneficial use" or "uses" of a water body or segment of a water body; ) the water quality "criteria" necessary to protect the uses of that particular water body; ) an antidegradation policy. typical designated beneficial uses of water bodies include public water supply, propagation of fish and wildlife, recreation, agricultural water use, industrial water use and navigation. if information concerning copcs is not present in the drinking water and/or state and tribal water standards databases, or additional exposure pathways need to be included during the site assessment, then media-specific comparison values are available from the soil screening guidance [ ] , several usepa regional offices, and individual state governments (table ). these benchmark values may be used as a tool to perform initial site screenings or as initial cleanup goals, if applicable. the different media-specific comparison values are generic, but can be recalculated using more site-specific information and guidance provided on the applicable web addresses (table ). however, they usually do not consider all potential human health exposure pathways or consider ecological concerns. many of the databases listed in table also provide copc concentration in soil calculated with fate and transport models that are protective of ground water and surface water. if information concerning copcs is not present in these databases, or additional exposure pathways need to be included during the site assessment, then a detailed toxicity evaluation and risk assessment may need to be conducted based on state or other regulatory agency guidelines. usepa was granted authority to set drinking water standards by the safe drinking water act (sdwa) of . the sdwa has since been amended in and . the responsibility for implementing drinking water standards is delegated to states and tribes. usepa is responsible for identifying contaminants to regulate, establishing priorities for contaminants that are of the greatest concern, and then deriving national primary drinking water regulations. the sdwa is applicable to public water systems that provide water for human consumption through at least service connections or regularly serve at least individuals. the standards apply to the water delivered to any user of a public water system. the standards are not applicable to private wells, although state and local governments do set rules to protect users of these wells. owners are urged to test their wells annually for nitrate and coliform bacteria, to test their wells for other compounds if a problem is suspected, and to take precautions to ensure the protection and maintenance of their drinking water supplies. even though these drinking water standards do not apply to private wells, many states adopt them as ground water standards or use them to evaluate whether concentrations of contaminants in ground water are above a level of concern. the office of water establishes national primary drinking water standards, secondary drinking water regulations, as well as health advisories. the derivation of these standards, regulations, and health advisories are discussed below. the drinking water standards and health advisories tables may be reached from the office of science and technology ( ost) home page at http://www.epa.gov/ost. the tables are accessed under the ost programs heading on the ost home page. national primary drinking water standards are regulations the usepa sets to control the level of contaminants in the nation's drinking water. maximum contaminant level goals (mclgs) are the maximum level of a contaminant in drinking water at which no known or anticipated chronic adverse effect on the health of persons would occur, and which allows an adequate margin of safety. mclgs are non-enforceable public health goals. maximum contaminant levels (mcls) are enforceable standards that are set as close to mclgs as possible but take into consideration the availability of technology treatments and techniques as well as whether reliable analytical methods capable of detecting low concentrations of contaminants are available. the derivation of mclgs and mcls are discussed in the following sections. for noncarcinogens (not including microbial contaminants), the mclg is based on the rid. the definition and derivation of the rid has been discussed previously. the rid is first adjusted for an adult with body weight assumed to be kg and consuming l of water per day to produce the drinking water equivalent level (dwel): the dwel represents the concentration of a substance in drinking water that is not expected to cause any adverse noncarcinogenic health effects in humans over a lifetime of exposure and assumes the only exposure to the chemical comes from drinking water. however, exposure to the chemical can also occur through other pathways and routes of exposure. therefore, the mclg is calculated by reducing the dwel in proportion to the amount of exposure from drinking water relative to other sources (e.g., food, air). in the absence of actual exposure data, this relative source contribution (rsc) is generally assumed to be %. the final value is in mg/l and is generally rounded to one significant figure: mclg(mg!l) = dwel · rsc ( ) if the chemical is considered to be a class a orb carcinogen, then it is assumed that there is not a dose below which the chemical is considered safe. therefore, the mclg is set at zero. if a chemical is a class c carcinogen and scientific data provides information that there is a threshold below which carcinogenesis does not occur, then the mclg is set at a level above zero that is safe. prior to , the mclg for class c carcinogens was based on an rid approach that applied an additional uncertainty factor of to account for possible carcinogenic potential of the chemical. if there weren't any reported noncancer effects, then the mclg was based on a nominal lifetime excess cancer risk of - to - , if data were adequate. the office of water is now moving toward guidance contained in the draft cancer guidelines [ , ] which allows standards for nonlin-ear carcinogens to be derived based on low dose extrapolation and a mode of action approach. for microbial contaminants that may present public health risk, the mclg is set at zero because ingesting one protozoa, virus, or bacterium may cause adverse health effects. usepa is conducting studies to determine whether there is a safe level above zero for some microbial contaminants. so far, however, this has not been established. as mentioned previously, maximum contaminant levels (mcls) are enforceable standards that are set as close to mclgs as possible but take into consideration the availability of technology treatments and techniques as well as whether reliable analytical methods capable of detecting low concentrations of contaminants are available. if there is not a reliable analytical method, than a treatment technique (tt) is set rather than an mcl. a tt is an enforceable procedure or level of technological performance, which public water systems must follow to ensure control of a contaminant. in addition, mcls take into account an economic analysis to determine whether the benefits of enforcing the standard justify the costs. for group a and group b carcinogens, mcls are usually promulgated at the o- to o- risk level. secondary drinking water regulations are non-enforceable federal guidelines that take into account whether a chemical produces cosmetic effects such as tooth or skin discoloration or aesthetic effects such as affecting the taste, odor, or color of drinking water. because there are at least different contaminates (i.e., aluminum, chloride, copper, and fluoride) in drinking water that are not considered to be health threatening, secondary maximum contaminant levels (smcls) guidelines have been established for public water systems that voluntarily test the water. these secondary standards give the public water systems guidance on removing the contaminants. in most cases, the state health agencies and public water systems often monitor and treat their drinking water for secondary contaminants. in order to provide information and guidance concerning drinking water contaminants for which national regulations currently do not exist, the usepa health and ecological criteria division, office of water, in cooperation with the office of research and development prepares health advisories (ha). these detailed has are used to "estimate concentrations of the contaminant in drinking water that are not anticipated to cause any adverse noncarcinogenic health effects over specific exposure durations" [ ] . they include a margin of safety to protect sensitive members of the population (e.g., children, the elderly, and pregnant women). has are not legally enforceable in the united states, are only used for guidance by federal, state and local officials, and are subject to change as new information becomes available. included in the has is information on analytical and treatment technologies. has are provided for acute or shortterm effects as well as chronic effects. the one-day ha, the ten-day ha and the longer-term ha are based on the assumption that all exposures to the contaminant comes from drinking water whereas the lifetime ha takes into account other sources such as food, air, etc. the following types of has have been developed [ ] . one-day ha -the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to one day of exposure. a one-day ha is generally based on data from acute human or animal studies involving up to days of exposure. the protected individual is assumed to be a -kg child with an assumed volume of drinking water (di) of lingested/day. ten-day ha-the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to ten days of exposure. a ten -day ha is generally based on subacute animal studies involving - days of exposure. similarly to the one-day ha, the protected individual for the ten-day ha is assumed to be a -kg child with an assumed di of l l ingested/ day. longer-term ha-the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to approximately seven years ( % of an individual's lifetime) of exposure, with a margin of safety. a longer-term ha is generally based on subchronic animal studies involving days to year of exposure. the protected individual is assumed to be a -kg child with an assumed di of l ingested/day and a -kg adult with an assumed di of ingested/day. lifetime ha -the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for a lifetime of exposure. a lifetime ha is generally based on chronic or subchronic animal studies. the protected individual is assumed to be a -kg adult with an assumed di of l ingested/day. a dwel is calculated and multiplied by a rsc of % to account for exposure to drinking water as well as other sources (food, air, etc.). therefore, the lifetime ha is derived similarly to the mclg. the following general formula is used to derive the one-day, ten-day, and the longer-term has and the dwel: health advisories for the assessment of carcinogenic risk ( ) if a contaminant is recognized as a human or probable human carcinogen (groups a or b), a carcinogenic slope factor (csf) is derived based on techniques discussed above. the slope factor is then used to determine the concentrations of the chemical in drinking water that are associated with theoretical upper-bound excess lifetime cancer risks of w- , w-s, or w- • the following formula is used to calculate the concentration predicted to contribute an incremental risk level (rl) of - , w- , or - : cvw(mg.il) = ___ : : : . . _ where cow concentration in drinking water at desired rl (mg/l) rl desired risk level (lo- , - , or assumed body weight of adult human (kg) csf carcinogenic potency factor for humans (mg/kglday}- assumed water consumption of an adult human (l!day). ( ) if a dwel was calculated for a class a, b, or c carcinogen based on an rid study, (i.e., noncarcinogen), then the carcinogenic risk associated with lifetime exposure to the dwel can be calculated to assist the risk manager for comparison in assessing the overall risks. the theoretical upper-bound cancer risk associated with lifetime exposure to the dwel is calculated as follows: lid· csf risk = dwel · ---- kg ( ) toxity evaluation and human health risk assessment of surface and ground water usepa is required by the clean water act of to develop, publish, and revise ambient water quality criteria (awqc). the awqc "involves the calculation of the maximum water concentration for a pollutant that ensures drinking water and/or fish ingestion exposures will not result in human intake of that pollutant (i.e., the water quality criteria level) in amounts that exceed a specified level based upon the toxicological endpoint of concern" [ ] . in october , usepa issued new guidelines [ ] that replaced the awqc national guidelines [ ] . the awqs guidelines incorporated significant scientific advances in the following key areas: cancer risk assessment ( cancer guidelines [ ] vs the draft cancer guidelines) [ , ] ; risk assessments for class c carcinogens using nonlinear low-dose extrapolation; non-cancer risk assessments (benchmark dose approach and categorical regression); exposure assessments (consideration of non-water sources of exposures); bioaccumulation in fish (bioaccumulation factors, bafs, are recommended for all compounds to calculate concentration in fish tissue). in addition, the procedures for deriving awqc under the cwa were made more consistent to the procedures for deriving mclg by the sdwa. this section will discuss guidelines from the methodology for deriving ambient water quality criteria for the protection of human health, hereafter referred to as the awqc methodology guidance [ ] , accessible at http:/ /www.epa.gov/ost/ humanhealth/method/index.html. state and tribal environmental agencies are responsible for developing ambient water quality standards (awqs) for each water body in the state based on guidance provided by usepa [ ] and the uses that water bodies have been designated for (i.e., drinking water supply, recreation, or fish protection, etc.). these designated uses are a part of the water quality standards, provide a regulatory goal for the water body and define the level of protection assigned to it. the watershed assessment, tracking&environmental results database (waters), accessible at http:/ /www.epa.gov/waters/ provides information on the water body designation for each individual state and tribe. the exposure pathways typically evaluated for awqc are direct ingestion of drinking water obtained from that water body and the consumption of fish/ shellfish obtained from that water body. when an awqc is set, anticipated exposures from other sources of exposure (e.g., food, air) are taken into account for noncarcinogenic effects, or carcinogenic effects evaluated by the margin of exposure (moe) approach (i.e., class c carcinogens, using the woe cancer guideline terminology). the amount of exposure attributed to each source compared to total exposure is called the relative source contribution (rsc) for that source. the rsc is typically set at % but if a site-specific assessment is conducted for a particular water body and it can be demonstrated that other sources of exposures are not likely to occur, then the rsc can be set as high as %. an exposure decision tree approach is described in the methodology guidance to assist in calculating a site-specific rsc for a water body [ ] . the allowable dose (typically, the rid) is then allocated via the rsc approach to ensure that the criterion is protective enough, given the other anticipated sources of exposure: where awqc ambient water quality criterion (mg/l) rid reference dose for non-cancer effects (mg/kg-day) rsc relative source contribution factor to account for non-water sources of exposure -may be either a percentage (multiplied) or amount subtracted, depending on whether multiple criteria are relevant to the chemical bw human body weight ( default= kg for adults) di drinking water intake (default= l/day for adults) fli fish intake at trophic level (tl) i (i= , , and ) (defaults for total in-take= . kg/day for general adult population and sport anglers, and . kg/day for subsistence fishers). trophic level breakouts for the general adult population and sport anglers are: tl = . kg/day; tl = . kg/day; and tl = . kg/day bafi bioaccumulation factor at trophic level i (i= , , and ), lipid normalized (l/kg). the following equation is used for deriving awqc for chemicals evaluated with a nonlinear low-dose extrapolation (margin of exposure) based on guidance in the draft cancer guidelines: where pod point of departure for carcinogens based on a nonlinear low-dose extrapolation (mg/kglday), usually a loael, noael, or ledlo uf uncertainty factor for carcinogens based on a nonlinear low-dose extrapolation (unitless). for carcinogens, only two water sources (i.e., drinking water and fish ingestion) are considered when awqc are derived. awqc for carcinogens are determined with respect to the incremental lifetime risk posed by a substance's presence in water, and is not being set with regard to an individual's total risk from all sources of exposure [ ] . the cancer guidelines are the basis for iris risk numbers that were used to derive the current awqc, except for a few compounds developed using the revised cancer guidelines [ , ] . each new assessment applying the principles of the draft cancer guidelines [ , ] will be subject to peer review before being used as the basis of revised, updated awqc. the cancer-based awqc was calculated using the risk specific dose (rsd) and other input parameters listed below. the rsd and awqc for carcinogens was calculated for the specific targeted lifetime cancer risk (i.e., iq- , iq- , iq- ), using the following two equations: where rsd risk specific dose (mg/kg/day) target cancer risk iq- , iq- , iq- (lifetime incremental risk) csf cancer slope factor (mg/kg-day)- ( ) ( ) exposure parameters based on a site-specific or regional basis can be substituted to reflect regional or local conditions and/or specific populations of concern. these include the relative source contribution, fish consumption rate, baf (including factors used to derive bafs such as concentration of particulate organic carbon applicable to the awqc (kg/l) or concentration of dissolved organic carbon applicable to the awqc (kg/l), percent lipid of fish consumed by target population, and species representative of given trophic levels. states and tribes are encouraged to make adjustments using the information and instructions provided in the awqc methodology guidance [ ] . the national water quality standards database (wqsdb) at the web address, http:/ /www.epa.gov/wqsdatabase/, provides access to several wqs reports that provide information about designated uses, water body names, state numeric water quality standards, and epa recommended numeric water quality crite-ria. the wqsdb allows users the ability to compare wqs information across the nation using standard reports. some states and tribes use an incidental ingestion value (ii) instead of di value when the water body is used for recreational purposes and not as a source of drinking water. however, an ii value is not used to develop national awqc. the default value for ii is . l!day and is assumed to occur from swimming and other activities. the fish intake value is assumed to remain the same. besides protection of human health, awqc are developed based on other criteria such as organoleptic effects; aquatic life protection, sediment quality protection, nutrient criteria, microbial pathogens, biocriteria, excessive sedimentation, flow alterations, and wildlife criteria. for example, the national recommended water quality criteria table (http:/ /www.epa.gov/ost/standards/wqcriteria.html) lists freshwater or saltwater criteria maximum concentration (cmc) criteria values that are the acute limits for the priority pollutant for the protection of aquatic life in freshwater or saltwater. the freshwater or saltwater criterion continuous concentration (ccc) criteria value is the chronic limit for the priority pollutant for the protection of aquatic life in freshwater or saltwater, respectively. the table also includes criteria for organoleptic effects for pollutants developed to prevent undesirable taste and/or odor imparted by them to ambient water. in some cases, a water quality criterion based on organoleptic effects or aquatic life protection would be more stringent than a criterion based on toxicologic endpoints. information and links to guidance documents relating to these subjects may be reached from the office of water, water quality criteria and standards program page at http://www.epa.gov/waterscience/standards/. as more knowledge is gained about the waste generated and disposed in landfllls by our society, there is great concern about the toxic effects that this waste has on our environment as well as animal and human health. over the past decade, there have been numerous attempts to recycle various waste products generated by our society. this section will review some of the recent literature on recycled hazardous waste materials. recycled concrete pavement as aggregate for the construction of highways can produce effluent with a high ph that can enter the underwater drains [ ] . when portland cement is recycled, the concrete consists of limestones and minerals where - % is lime ( cao ), silica (si }, alumina (al }, and iron oxide (fe ). ca(oh} is formed sparingly in water and the saturated solution has a ph of . at oc. the ph of the water effluent in underdrains is approximately - . at this ph, the cac precipitates out and forms deposits on the screen [ ] . the deposition on the screens produces clogging and scales to form in the underdrain; thereby, causing vegetative kill around the outlet. in addition to recycled concrete, rubber is recycled for asphalt pavements. recycling of rubber allows a means of disposal of scrap tires and reduces the quantity of construction materials for the asphalt. asphalt pavement contains hot mix asphalt with and without crumb rubber modifier. the use of rubber tires reduces the weight of the asphalt and provides good drainage media as well as extending the life of the asphalt [ ] . while there is an apparent benefit for recycling rubber, it has been found by the minnesota pollution control agency that leaching can occur from the use of waste tires in sub grade roadbeds into the run -off water. in acidic conditions, leaching of barium, cadmium, lead, chromium, selenium, and zinc occurred from the asphalt while in basic conditions, there was leaching of polynuclear aromatic hydrocarbons. thus, the recommended allowable levels (rals) may be exceeded for drinking water standards in areas where there is recycled rubber in the asphalt. paper or wood itself does not contain any hazardous chemicals unless the paper undergoes recycling. the recycling process requires de-inking of waste paper prior to recovery of the fiber generating a sludge that contains particles of ink and fibers too short to be converted to a finished paper product [ ] . the de-inking chemicals such as sulfur, chlorine, cadmium, and fluorine are present in the sludge generated. a sludge is any solid, semi-solid, or liquid waste generated from a municipal, commercial, or industrial wastewater treatment plant, water supply treatment plant, or air pollution control facility exclusive of treated effluent from a wastewater treatment plant [ ] . thus, hazardous waste can be generated from the recycling paper process. a commodity used by numerous industries is plastic. because of the enormous amount of plastic disposed by consumers on a daily basis, it has become a common recycled item at many facilities. some metal sites will recycle the plastic insulation generated by their facility. the recycled plastic from such a facility generally includes metals such as lead, copper, manganese, and zinc, as well as dioxins, polychlorinated naphthalene, and polychlorinated biphenols. a leachate, contaminated run -off water, from the plastic "fluff" is formed during the recycling process. the leachate runs off into the water drains carrying hazardous chemical residue into soil and ground water. the plastic fluff is generally recycled on site into tiles, cushions, traffic cones, fenders, and highway barriers. the non-recyclable material and contaminated soil is generally taken to an off-site landfill. another common way to recycle plastic is to use the "sink-float" process where paper, fiber, and metal can be separated from the plastics and then recycled. the "sink-float" process uses water where the heavy items sink and the light items float [ ] . it has been demonstrated that recycled plastics can be used as construction material as an alternative to lumber. this product is made from used bottles collected at curbside for recycling. the recycled plastics undergo sorting to remove unpigmented polyethylene milk/water jugs and polyethylene terephthalate carbonated beverage bottles. the leftover plastic material is referred to as curbside tailings (ct). ct consists of approximately % polyolefin (polyethylene and polypropylene) with the remaining percentages made of polyethylene terephthalate, polystyrene, polyvinyl chloride, and other plastics [ ] . the ct product has reasonable strength compared to wood. we is et al. ( ) evaluated three ct recycled plastic formulations in fiddler crabs, snail, and algae [ ] . it was found that limb regeneration of the fiddler crabs was accelerated with all three formulations but had no effect on fertilized eggs or larval developments formulations. there was a significant reduction in the sperm fertilization success rate [ ] . furthermore, all three ct plastic formulation did not have an affect on the survival rate of snails or other algal species. the presence of metals in sludge and wastewater is a current problem. for instance, the use of sludge as a fertilizer of agricultural land generally receives cadmium (cd++) from aerial deposition and phosphatic fertilizers. cd++ is considered a hazardous chemical and has been shown to produce toxicity of the lung and kidney and to be carcinogenic in rats [ ] . the highest concentration of cd++ is found in tobacco, lettuce, spinach, and other leafy products/vegetables. using crop uptake data from field trials, it is possible to relate potential human dietary intake of cd++ on which hazard depends, to soil concentrations of cadmium [ ] . transfer via farm animals to meat and dairy products for human consumption is thought to be minimal even allowing for some direct ingestion of sludge-treated soil by the animals. background soil contains . to . mg cd++ /kg where % of cadmium is found in raw sewage that is converted to sludge. after the formation of sludge, % of the % cd++ is removed primarily by sedimentation. in order for cd++ uptake in roots to occur, cd++ must be in its soluble form adjacent to the root membrane for some finite period [ ] . generally, a decrease in ph in soil will enhance the solubility of cd++, which will increase the crop uptake of cd++. in , who/usepa agreed that the maximum acceptable daily uptake of cd++ was f.lg/day. where -lg cd++jday over a -year period would be necessary to produce toxicity to the kidney. farm animals fed fodder crops grown on sludge-treated soil will absorb ~ % of the cd++ ingested [ ] . in addition to recycling cd++, lead (pb )-edta wastewater also undergoes recycling. edta a chelating agent used in the soil washing process for the decontamination of pb contaminated soil. kim et al. [ ] outlines a method to recycle pb-edta wastewater by substituting the pb-edta complex with feh ions at a low ph followed by precipitation of pb ions with phosphate or sulfate ions. feh ions-edta will precipitate at a high ph with naoh. the recycled edta solution can be recycled several times without losing its extractive power [ ] . recycling computers can be extremely hazardous if not properly disposed. there are many parts of the computer that are toxic. to begin with, the cathode ray tube (crt) glass may be classified as a hazardous waste due to its high pb concentration. the liquid crystal display (lcd), which contains benzene material for the liquid crystal, is also considered hazardous. in addition, the mercury switch, mercury relay, lithium battery, ni-h battery, ni-cd battery, and polychlorinated biphenyl (pcb) capacitor are all hazardous materials. because of this, taiwan has recently established guidelines for the proper disposal of computer and/or computer parts [ ] . the nine guidelines are: i) landfill or incineration of scrap computers shall be avoided; ii) the phosphorescent coatings which have been applied to the glass panel of crt must be removed; iii) all the batteries (li, ni-cd,ni-h) must be removed by non-destructive means; iv) all the pcb capacitors which have a diameter greater than em and a height larger than em must be removed; v) all the mercury containing parts must be removed; vi) crt must be ventilated before stored inside a building; vii) the high-ph content funnel glass of the crt must be properly treated; viii) the lcd of notebook computer must be removed by non-destructive means; and lastly, ix) plastic that contains the flameretardant, bromine, shall be treated properly. hopefully, this model can be used in other countries where computer waste is becoming a major issue of environmental concern. organic solvents have many applications in the industry such as formulation of products, thinning of products prior to use or cleaning of materials by removal of contaminants. during this application, solvent emission and waste solvent generation occur. most organic solvents are known to have adverse effects on both human health and the environment. solvents may affect the body through inhalation and skin contact and lead to either acute or chronic poisoning [ ] . the effects of acute poisoning include narcosis, irritation of throat, eyes, or skin, dermatitis, and even death and the effects of chronic poisoning include damage to blood, lung, kidney, and gastrointestinal system and/or nervous system. in addition, many solvents are inflammable in nature. waste management of organic solvents includes: source reduction, recycling, treatment, and disposal [ ] . case studies indicate that dry cleaning facilities use perchloroethylene (perc) in which workers around the cleaning machines are subject to high health risks; thus, vapor recovery systems are used to reduce the perc emissions especially from older machines [ ] . riess et al. [ ] evaluated the recyclability of flame-retarded polymers that contain brominated flame-retardants from televisions (tv) and personal computers (pcs) obtained from a recycling company. the flame-retardants identified in the tv were: % high-impact polystyrene, % acrylonitrile butadiene styrene, % polystyrene, and % polyphenyleneoxide polystyrene. the flame retardants found in pcs were: % acrylonitrile butadiene styrene, % polyphenyleneoxide polystyrene, % high-impact polystyrene, % polystyrene, and % polyvinyl chloride. recycling may be practical if % new material is added to mixture [ ] . the denver potable reuse pilot project began in to recycle wastewater effluent to achieve potable water quality as well as being economically competitive with conventional technology. moreover, this project sponsored the first large-scale risk assessment studies using experimental animals [ ] . after ten years, this pilot project was converted to a demonstration treatment plant to address many of the technical and non-technical issues. the objectives of the "reuse demonstration project were (i) to establish end product safety, (ii) to demonstrate the reliability of the process, (iii) to generate public awareness, (iv) to generate regulatory agency acceptance, and (v) to provide data for a largescale implementation" [ ] . however, insuring end-product water safety proved to be difficult to demonstrate because the health standards established for drinking water were not intended to apply to treated waters. thus, additional criteria were used to prove that the effluent was suitable for human consumption. below were the criteria used in this project: -the product was compared with the national primary and secondary drinking water regulations values -the product was compared with federal or state regulated parameters -effluent levels were compared with the levels suggested to be hazardous -concentrations of product in the water were compared to denver's current drinking water criteria or other "acceptable" water supplies in the u.s. and/or worldwide -whole-animal studies (i.e., chronic toxicity, oncogenicity, and reproductive tests) were conducted using denver's current drinking water as a comparison standard the denver project used two dosage groups per water sample: reclaimed water from the demonstration plant with reverse osmosis treatment (rot) and denver drinking water from the foothills water treatment plant (dwt). ro and dw were administered to fischer rats and b c f mice at dosages at least times the amount found in the original water samples. ultrafiltration water treatment samples (uft) were only administered to rats at the high dose (soox) and distilled water was used as the control in both the rats and mice studies. in addition to the chronic toxicity studies, reproductive toxicity studies were performed to identify potential adverse effects on reproductive performance, intrauterine development, and growth and development of the offspring. the teratology phase will identify potential embryotoxicity and teratogenicity. administration of ro, uft, and dw water at times the amount found in the original water samples for weeks in rats did not result in any toxicologic or carcinogenic toxicity [ ] . the survival rate was slightly higher among the female rats ( %- %) compared to the male rats ( %- %). there were a variety of neoplasms seen in all treatment groups ( table ) . the "c" cell tumors in the thyroids were not considered treatment related because these neoplasms were within the anticipated ranges for the age and strain of the rat. similar results were seen with the mouse chronic studies where there was no toxicity or carcinogenicity seen after weeks of high dose treatment and the survival rate was identical to the rats. the organs most affected by the treatment were the hematopoietic system, liver, lung, and pituitary gland [ ] . the remarkable finding of the reproductive studies was "the absence of treatment- related effects on reproductive performance, growth, mating capacity, survival of offspring, or fetal development in any of the treatment groups" [ ] . the denver project met the outlined objectives at the start of the project and all three of the toxicity studies demonstrated that concentrations times the original amount seen in sample water did not cause any notable toxicity. thus, secondary wastewater can be recycled into safe drinking water for human consumption. chemical mixtures have always been an issue of concern to address/assess the toxicity to the environment and to humans. an interagency agreement between atsdr and the ntp resulted in participation in a public health service (phs) activity related to the superfund act (cercla comprehensive environmental response, compensation and liability act) [ ] . yang was the lead scientist at the national institute of environmental health sciences (niehs)/ntp for the development of the "superfund toxicology program". particular focus centered on chemical mixtures of environmental concern, especially groundwater contaminants derived from hazardous waste disposal and agricultural activities. yang states that obtaining a "representative" sample is practically impossible [ ] . a core sample from one location of a site will definitely be different from a core sample from a different location of a site. also, a core sample taken from the exact location at different times of day and/or different days will be different because weather, activity at the site, and composition of the waste can change and degrade or synthesize new compounds. thus, yang proposed a strategy to study chemical mixtures [ ] : . study chemical mixtures between binary and complex mixtures to avoid duplication of earlier studies that evaluated the two extremes . study chemically defined mixtures to make determination and mechanistic studies manageable . study chemical mixtures related to groundwater contamination because groundwater contamination is among the most critical environmental issue . study chemical mixtures at environmentally realistic concentrations to access the potential health effects of environmental pollution of long-term, low-level exposure . study chemical mixtures with potential for life-time exposure. a chemical mixture of groundwater contaminants from hazardous waste sites and agricultural activities were created. this formulation mixture contained -chemicals that simulated groundwater contamination as shown in table . the concentrations selected represent the average survey values of hazardous waste disposal sites representing all usepa regions. even though such a mixture may never exist in reality, new insights may be gained to elucidate potential health effects from laboratory animals to human. for most of the end-points examined in this study, the results were negative. the negative results of this study were significant because various mixtures were tested at -to -fold or several orders of magnitude higher than potential human exposure levels [ ] . insights gained from yang's project were: i) the effects will be subtle and marginal; ii) toxicologic interactions are possible at the environmentally realistic levels of exposure; iii) toxic responses may be from unconventional toxicologic end-point (immunosuppression, myelotoxicity); iv) possibility of subclinical residual effects may become more interactive with subsequent insults from chemical, physical, and/or biological agents; and v) negative results do not in-toxity evaluation and human health risk assessment of surface and ground water dicate safety for humans because the studies were done on rodents. subsequent work on this mixture at low doses increased the acute toxicity of high doses of known hepatic and renal toxicants [ ] . recently, niehs has begun to focus on simpler mixtures of chemicals that share common mechanisms of action rather than complex mixtures. over the past several decades, much effort has been made to establish national guidance on 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systems and clogging of underdrain systems assessment of water pollutants from asphalt pavement containing recycled rubber in rhode island the rhode island department of transportation waste-to-energy plant for paper industry sludges disposal: technical-economic study superfund at work: hazardous waste cleanup efforts nationwide. us epa, solid waste and emergency response toxicity of construction materials in the marine environment: a comparison of chromated-copper-arenate-treated wood and recycled plastic the control of the heavy metals health hazard in the reclamation of wastewater sludge as agricultural fertilizer cadmium -a complex environmental problem. part ii recycling of lead-contaminated edta wastewater management of scrap computer recycling in taiwan management, disposal and recycling of waste industrial organic solvents in hong kong analysis of flame retarded polymers and recycling materials chemosphere health effect studies on recycled drinking water from secondary wastewater. in: yang rsh ( ed) toxicology of chemical mixtures toxicology of chemical mixtures derived from hazardous waste sites or application of pesticides and fertilizers. in: yang rsh (ed) toxicology of chemical mixtures toxicology studies of a chemical mixture of groundwater contaminants: hepatic and renal assessment, response to carbon tetrachloride challenge, and influence of treatment-induced water restriction texas natural resource conservation commission ( ) texas risk reduction program rule review draft addendum to the methodology for assessing health risks associated with indirect exposure to combustor emissions estimating exposure to dioxin-like compounds review draft development of human health-based and ecologically-based exit criteria for the hazardous waste identification project. office of solid waste i and ii cw · ir · ef · ed intake=--------- bw a a number of studies has shown that an age-adjusted approach should be used to calculate intakes for children for carcinogens to take into account the difference in ingestion rates, body weights, and exposure duration for children from to years old and others from to years [ ] . b the exposure parameters were taken from the texas risk reduction program rule [ ] and are provided as examples only. different regulatory or state agencies may recommend different exposure parameters based on scientific policy or risk management decisions. [ ] . ' use only when a rid is based on health effects in children [ ] . d the office of water is in the process of preparing an exposure assessment technical support document in which an age-adjusted approach will be used to calculate fish intakes for children for carcinogens to take into account the difference in ingestion rates, body weights, and exposure duration for children from to years old and others from to years [ ] . for copcs whose log k w< . for copcs whose log kow> . cf = cw · baf for dioxins, furans, and polychlorinated biphenyls cf = csed · bsaf cf =chemical concentration in fish (mg/kg), fresh weight (fw) cw =chemical concentration in water (mg/l) bcf =bioconcentration factor (l/kg fw)h baf =bioaccumulation factor (l/kg fw)b c,ed =chemical concentration in sediment (mg/kg) bsaf =biota-sediment accumulation factor (unitless)<• please refer to reference [ ] for a detailed discussion of procedures used to calculate chemical concentration in fish. different regulatory or state agencies may recommend different procedures based on scientific policy or risk management decisions [ , ] . b please refer to appendix a- of reference [ ] for bcf, baf, and bsaf values and procedures for calculating these values. also, please refer to [ , ] . c bsafs are used to account for the transfer of copcs from the bottom sediment to the lipid in fish [ , [ ] [ ] [ ] . organic compounds non-steady state" not applicable for inorganics cinh =the concentration of copc at the exchange boundary (mglm ) cw =chemical concentration in water (mg/l) vf =volatilization factor [(mglm )/(mg!l-h )]• ef =exposure frequency (days/year)h ed =exposure duration (years)h at =averaging time in years (period over which exposure is averaged)h a specific fate and transport models are used to derive volatilization factors to quantify the transfer of volatile copcs from ground water into an enclosed space, from ground and surface waters into ambient air, etc. these fate and transport models are discussed elsewhere in this book. b the exposure parameters for ef, ed, and at from appendix a - can be used for the residential adult, residential child, and commercial/industrial worker for some pathways, but site-specific exposure parameters may need to be developed for other pathways. key: cord- - w fkd authors: nan title: abstract date: - - journal: eur j epidemiol doi: . /s - - - sha: doc_id: cord_uid: w fkd nan the organisers of the european congress of epidemiology , the board of the netherlands epidemiological society, and the board of the european epidemiology federation of the international epidemiological association (iea-eef) welcome you to utrecht, the netherlands, for this iea-eef congress. epidemiology is a medical discipline that is focussed on principles and methods of research on causes, diagnosis and prognosis of disease, and establishing the benefits and risks of treatment and prevention. epidemiological research has proven its importance by contributions to the understanding the origins and consequences of diseases, and has made major contributions to the management diseases and improvement of health in-patients and populations. this meeting provides a major opportunity to affirm the scientific and societal contributions of epidemiological research in health care practice, both in clinical medicine and in public health. during this meeting major current health care problems are addressed alongside methodological issues, and the opportunities and challenges in approaching them are explored. the exchange of ideas will foster existing co-operation and stimulate new collaborations across countries and cultures. the goal of this meeting is to promote the highest scientific quality of the presentations and display advanced achievements in epidemiological research. our aim is to offer a comprehensive and educational programme in the field of epidemiological research in health care and public health, and create room for discussions on contemporary methods and innovations from the perspective of policy makers, professionals and patients. above all, we want to stimulate open interaction among the congress participants. your presence in utrecht is key to an outstanding scientific meeting. the european congress of epidemiology is organised by epidemiologists of utrecht university, under the auspices of the iea-eef, and in collaboration with the netherlands epidemiological society. utrecht university, founded in , is the largest university in the netherlands and harbours the largest academic teaching hospital in the netherlands. the epidemiologists from utrecht university work in the faculties of medicine, veterinary medicine, pharmacy and biology. the current meeting was announced through national societies, taking advantage of their newsletters and of the iea-eef newsletter. in addition, avoiding the costs and disadvantages of the traditional journal advertisements and leaflets, information about the congress was disseminated via an internet mailing list of epidemiologists, which was compiled from, among other, the meeting in porto in , the european young epidemiologist network (http://higiene.med.up.pt/eye/) and several institutions and departments. many of the procedures followed this year were based on or directly borrowed from the stimulating iea-eef congress in porto in . publication in an international journal of large circulation of the congress programme and abstracts selected for oral and poster presentation, signifies the commitment of the organisers towards all colleagues that decided to present their original work at our meeting, and is intended to promote our discipline and to further stimulate the quality of the scientific work of european epidemiologists. and methods to the objectives and quality of its description; presentation of results; importance of the topic; and originality. a final rating was given on a - point scale. the two junior epidemiologists independently evaluated each abstract. based on ratings of the juniors, the senior epidemiologist gave a final abstract rating. the senior reviewer decided when juniors disagreed, and harnessed against untoward extreme judgements of the juniors. based on the judgement by the seniors abstracts with a final rating of or higher were accepted for presentation. next, in order to shape the scientific programme according to scientific and professional topics and issues of interest for epidemiologists, members of the scientific programme committee grouped the accepted abstracts in major thematic clusters. for these, topics, keywords and title words were used. within each cluster, abstracts with a final rating of or higher, as well as abstracts featuring innovative epidemiological approaches were prioritised to be programmed as an oral presentation. the submitted abstracts had an average final rating of (sd= ). in total abstracts ( %) with a final rating of or lower were rejected. because of the thematic programming some abstracts with a final rating of or higher will be presented as posters, while few with a final rating of are programmed as oral presentation. there were abstracts ( %) accepted and programmed for poster presentation; each poster will be displayed for a full day. in total abstracts ( %) are accepted for oral presentation. these are programmed in parallel sessions. based on the topics of their abstracts the oral sessions were arranged into themes, notably epidemiology of diseases, methods clinical & population research, burden of disease, high risk populations, growth and development, public health strategies, translational epidemiology. sessions from one theme never are programmed parallel. in table we present the submitted and accepted abstracts (oral or poster) according to the distribution of country of origin. in table submitted abstracts are displayed according to their topic, as classified by the authors using the topic long list of the submission form. the scientific programme committee convened in a telephone meeting by the end of the summer of and decided on the above programming process. the scientific programme committee was informed on the result of the programming process by the end of april . fifteen abstracts were submitted for the eye session work in progress. of these abstracts were selected for oral presentation and thereby nominated for the eye award. in total, abstracts were submitted in relation to the student award, of which were programmed for oral presentation and thus nominated. during the congress authors of poster presentations may name themselves as candidate for the poster award. during the closing ceremony the winners of the student award and the poster award will be announced. these awards are an initiative of the netherlands epidemiological society that will fund them in . according to the iea rules expenses of congress participation for applicants from low-income countries will be covered. the board of the iea-eef will select a maximum of candidates; their travel and registration expenses will be (partly) covered from the congress budget. in order to stimulate participation form as many as possible junior researchers and young epidemiologists the congress budget covers registration fee reduction for undergraduate (msc) participants and eye members. this also holds for the registration fee reduction of iea-eef members and nes members. it is years ago ( ) that the iea regional european meeting was held in the hague, the marcon wei leray gehring leray spallek greving laan brussee brussee may- de groot hoefman goettsch posters ordered by abstract number olawuyi de vries uotinen smits gimeno houben de vries de vries ten berg diaconu diaconu streppel belo sauvaget koopman kilsztajn pembrey schmidt kretzschmar scholtens defraye medronho eljedi van de garde mello hosper feleus bayingana de wit stolk teixeira teixeira verhoef capon de boer lazarevska terschu¨ren khosravi boroujeni molag mikolajczyk luijsterburg stolk mirabelli barreto curzio pereira van gageldonk-lafeber van nispen roobol mokkink rava haukka jansen de kraker bogers donalisio behrens borders melis pac muller van den hooven van der sande van den berg novoa van den boogaard vannoord koedijk kuczerowska giorgi rossi vannoord baussano agabiti bierma-zeinstra van wier faustini jarrin juhl miguel maira lindert van den berg mierzejewska fonseca cardoso martens cotton corte ursoniu vernic boer ruskamp szurkowska bijkerk fonseca cardoso mazur ahrens dijkstra ajdacic-gross ajdacic-gross lucas santos gielkens-sijstermans tobi de kraker proteomics and genomics are supposed to be related to epidemiology and clinical medicine, among other because of the putative diagnostic usefulness of proteomics and genomics tests. hence, clinical and sometimes even public health applications are promised by basic sciences. it is debated whether such promises and subsequent expectation are fulfilled. what are at meaningful and consequential examples of current findings in proteomics, genomics and similar approaches in biomedical research? are they different from the ''classic'' tools and frameworks of clinical epidemiology? in the context of proteomics and genomics, etiologic studies, primary prevention, epidemiological surveillance and public health are concerned with the influence of environmental exposures on gene expression and on the accumulation of genetic alterations. proponents and advocates of proteomics and genomics have suggested that their products can yield clinically useful findings, e.g., for early diagnosis, for prognosis, for therapeutic monitoring, without always needing to identify the proteins, peptides or other 'biomarkers' at stake. do we feel comfortable with this ''black-box'' reasoning, i.e. do we question the role of pathophysiological and mechanistic reasoning in clinical medicine? how much sense does it make for epidemiology to play with and scrutinize proteomics and genomics approaches in epidemiology and clinical medicine? what are at present (and in the near future) the main biological, clinical and public health implications of current findings in these research fields? in this plenary session these and other questions regarding the place and role of proteomics and genomics in clinical epidemiological research are discussed from different perspectives. infection diseases: beneficial or disaster for man? infectious diseases pose an increasing risk to human and animal health. they lead to increasing mortality, in contrast to the situation fifty years ago when new control measures still provided hope of overcoming many problems in the future. improved hygiene, better socio-economic circumstances, vaccination and use of antibiotics has led to a gradual decline of tuberculosis, rheumatic fever, measles and mumps in western societies over the last five decades. paradoxically, absence of exposure to infectious agents has a major impact as well. the decline in infectious disease risk is accompanied by a gradual increase of allergic and autoimmune diseases and this association is believed to be causal. exposure to infectious agents from early on in life can markedly boost an individual's natural resistance and hence influence the individual's reaction to future exposure to both biological and non-biological antigens. in this plenary session we want to emphasise both aspects of the effect of infectious agents on human and animal health. evidence based medicine in health care practice and epidemiological research p. glasziou & l. bonneux evidence-based medicine is defined as the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. proponents of evidence-based medicine maintain that coming form a tradition of pathophysiological rationale and rather unsystematic clinical experience, clinical disciplines should summarize and use evidence concerning their practices, by using principles of critical appraisal and quantitative clinical reasoning. for this they should convert clinical information needs into answerable questions, locate the available evidence, critically appraise that evidence for its validity and usefulness, and apply the results of the best available evidence in practice. applying the principles of evidence-based medicine implies improvement of the effectiveness and efficiency of health care. therefore, evidence-based medicine has commonalties with clinical medical and epidemiological research. for integration of evidence-based medicine into health care practice the challenge is to translate knowledge from clinical medical and epidemiological research, for example in up to date practice guidelines. the limitations of using evidence alone to make decisions are evident. the importance of the values and preference judgments that are implicit in every clinical management decision are also evident. critics of evidence based medicine argue that applying best available research evidence in practice in order to improve the effectiveness and efficiency of health care contradicts with the importance of the values and preference judgments in clinical management decisions. in this plenary session we want to contrast these and other viewpoints on evidence based medicine in health care practice. statistical topics i: missing data prof. dr. t. stijnen this workshop will be an educational lecture on missing data by professor stijnen from the department of epidemiology and biostatistics of the erasmus mc rotterdam, the netherlands. every clinical or epidemiological study suffers from the problem of missing data. in practice mostly simple solutions are chosen, such as restricting the analysis to individuals without missing data or imputing missing values by the mean value of the individuals with observed data. it is not always realised that these simple approaches can lead to considerable bias in the estimates and standard errors of the parameters of interest. in the last to years much research has been done to better methods for dealing with missing values. in this workshop first an overview will be given of the methods that are available and their advantages and disadvantages will be discussed. most attention will be given to multiple imputation, to date generally considered as the best method for dealing with missing values. also the available software in important statistical packages such as spss and sas will be shortly discussed. prof. dr. b. van hout suppose that one wants to know how often individuals have a certain characteristic, and suppose that one doesn't have any knowledge -any knowledge at all -how often this is the case. now, suppose that one starts by checking individuals and only finds individual with this characteristic. than the probability that the ' th individual has the characteristic is / . the fact that this is not / (although it will be close to that if the numbers of observations increase) may be counter-intuitive. it will become less so, when realising how it is obtained from the formal integration of the new information with the complete uncertainty beforehand. this formal integration, with a prior indicating that it is as likely to be / as it is to be / as it is / , and with negative and positive observation -is by way of bayes rule. the italian mathematician, actuary, and bayesian, bruno de finetti ( - , estimated that it would take until the year for the bayesian view of statistics to completely prevail. the purpose of this workshop is to not only convince the attendants that this is appealing outlook but also to aid the workshop participants in realising this prediction. after a first introduction of the work of reverend bayes, a number of practical examples are presented and the attendant is introduced in the use of win-bugs. a first example -introducing the notion of noninformative priors -concerns a random effects logistic regression analysis. second, the use of informative priors, is illustrated (in contrast with non-informative priors) using an analysis of differences in quality of life as observed in a randomised clinical trial. it will be shown how taking account of such prior information changes the results as well as showing how such information may increase the power of the study. in a third example, it will be shown how winbugs offers a powerful and flexible tool to estimate rather complex multi-level models in a relatively easy way and how to discriminate between various models. within this presentation some survival techniques (or stress control techniques) will be presented for when winbugs starts to spit out obscure error-codes without giving the researcher any clue where to search for the reason behind these errors. communicating research to the public h. van maanen, prof. dr. ir. d. kromhout, a. aarts most researchers will at some point in their career face difficulties in communicating research results to the public. whereas most scientific publications will pass by the larger public in silence, now and then a publication provokes profound interest of popular press. interest from the general public should be regarded as positive. after all, public money is put into research and a researcher has a societal responsibility of spreading new knowledge. however, often, general press interest is regarded upon as negative by the researcher. the messages get shortened, distorted or ridiculed. whose responsibility is this misunderstanding between press and researchers? should a researcher foresee press reaction and what can be done to prevent negative consequences? is the press responsible background and relevance: patients with a carotid artery stenosis, including those with an asymptomatic or moderate stenosis, have a considerable risk of ischemic stroke. identification of risk factors for cerebrovascular disease in these patients may improve risk profiling and guide new treatment strategies. objectives and question: we cross-sectionally investigated whether carotid stiffness is associated with previous ischemic stroke or tia in patients with a carotid artery stenosis of at least %. design and methods: patients were selected from the second manifestations of arterial disease (smart) study, a cohort study among patients with manifest vascular disease or vascular risk factors. arterial stiffness, measured as change in lumen diameter of the common carotid arteries during the cardiac cycle, forms part of the vascular screening performed at baseline. the first participants with a stenosis of minimally % in at least one of the internal carotid arteries measured by duplex scanning were included in this study. logistic regression analysis was used to determine the relation between arterial stiffness and previous ischemic stroke or tia. results: the risk of ischemic stroke or tia in the highest quartile (stiffest arteries) relative to the lowest quartile was . ( % ci . - . ). these findings were adjusted for age, sex, systolic blood pressure, minimal diameter of the carotid artery and degree of carotid artery stenosis. conclusion and discussion: in-patients with a ‡ % carotid artery stenosis, increased common carotid stiffness is associated with previous ischemic stroke and tia. measurement of carotid stiffness may improve selection of high-risk patients eligible for carotid endarterectomy and may guide new treatment strategies. background (and relevance): patients with advanced renal insufficiency are at increased risk for adverse cardiovascular disease (cvd) outcomes. objectives and question: the aim was to establish whether impaired renal function is an independent predictor of cvd and death in an unselected high-risk population with cvd. design and methods: the study was performed in patients with cvd. primary outcomes were all vascular events and all cause death. during a median follow-up of months, patients had a vascular event ( %) and patients died ( . %). results: the adjusted hazard ratio (hr) of an estimated glomerular filtration rate < vs > ml/min per . m was . ( % ci . - . ) for vascular events and . ( % ci . - . ) for all cause death. for stroke as a separate outcome it was . ( % ci . - . ) . subgroup analysis according to vascular disease at presentation or the risk factors hypertension, diabetes and albuminuria had no influence on the hr's. conclusion and discussion: renal insufficiency is an independent risk factor for adverse cvd events in patients with a history of vascular disease. renal function was a particularly important factor in predicting stroke. the presence of other risk factors hypertension, diabetes or albuminuria had no influence on the impact of renal function alone. background and relevance: patients with hypertension have an increased case-fatality during acute mi. coronary collateral (cc) circulation has been proposed to reduce the risk of death during acute ischemia. objectives and question: we determined whether and to which degree high blood pressure (bp) affects the presence and extent of cc-circulation. design and methods: cross-sectional study in patients ( % males), admitted for elective coronary angioplasty between january and july . collaterals were graded with rentrop's classification (grade - ). ccpresence was defined as rentrop-grade ‡ . bp was measured twice with an inflatable cuff-manometer in seated position. pulse pressure was calculated by systolic blood pressure (sbp) )diastolic blood pressure (dbp). mean arterial pressure was calculated by dbp + / *(sbp-dbp). systolic hypertension was defined by a reading ‡ mmhg. we used logistic regression with adjustment for putative confounders. results: sbp (odds ratio (or) . per mmhg; % confidence-interval (ci) . - . ), dbp (or . per mmhg; % ci . - . ), mean arterial pressure (or . per mmhg; % ci . - . ), systolic hypertension (or . ; % ci . - . ), and antihypertensive treatment (or . ; % ci . - . ), each were inversely associated with the presence of cc's. also, among patients with cc's, there was a graded, significant inverse relation between levels of sbp, levels of pulse pressure, and collateral extent. conclusion and discussion: there is an inverse relationship between bp and the presence and extent of cc-circulation in patients with ischemic heart disease. background and relevance: silent brain infarcts are associated with decreased cognitive function in the general population. objectives and question: we examined whether this relation also exists in patients with symptomatic arterial disease. furthermore, we compared cognitive function of patients with stroke or tia, with cognitive function of patients with symptomatic arterial disease at other sites in the arterial tree. design and methods: an extensive screening was done in consecutive patients participating in the second manifestations of arterial disease (smart) study, including a neuropsychological test. inclusion diagnoses were cerebrovascular disease, symptomatic coronary artery disease, peripheral arterial disease, or abdominal aortic aneurysm. mri examination was performed to assess the presence of silent infarcts in patients without symptomatic cerebrovascular disease. the patients were assigned to one of three categories according to their patient history and inclusion diagnosis: no stroke or tia, no silent infarcts (n = ; mean age years); no stroke or tia, but silent infarcts present (n = ; mean age years); stroke or tia at background and relevance: patients with manifest vascular disease are at high risk of a new vascular event or death. modification of classical risk factors is often not successful. objectives and question: we determined whether the extra care of a nurse practitioner (np) could be beneficial to the cardiovascular risk profile of high-risk patients. design and methods: randomised controlled trial based on the zelen design. patients with manifestations of a vascular disease and who had ‡ modifiable vascular risk factors were prerandomised to receive treatment by a np plus usual care or usual care alone. after year, risk factors were re-measured. primary endpoint was achievement of treatment goals for risk factors. results: of the pre-randomised patients, of ( %) in the intervention group and of ( %) in the control group participated in the study. after a mean follow-up of months, the patients in the intervention group achieved significantly more treatment goals than did the patients in the control group (systolic blood pressure % versus %, total cholesterol % vs %, ldl-cholesterol % vs %, and bmi % vs %). medication use was increased in both groups and no differences were found in patients' quality of life (sf- ) at followup. conclusion and discussion: treatment delivered by nps, in addition to a vascular risk factor screening and prevention program, resulted in a better management of vascular risk factors compared to usual care alone in vascular patients after year follow-up. were used as non-invasive markers of vascular damage and adjusted for age and sex if appropriate. results: the prevalence of the metabolic syndrome in the study population was %. in pad patients this was %; in chd patients %, in stroke patients % and in aaa patients %. patients with the metabolic syndrome had an increased mean imt ( . vs. . mm, p-value < . ), more often a decreased abpi ( % vs. %, p-value . ) and increased prevalence of albuminuria ( % vs. %, p-value . ) compared to patients without this syndrome. an increase in the number of components of the metabolic syndrome was associated with an increase in mean imt (p-value for trend < . ), lower abpi (p-value for trend < . ) and higher prevalence albuminuria (p-value for trend < . ). conclusion and discussion: in patients with manifest vascular disease the presence of the metabolic syndrome is associated with advanced vascular damage. background (and relevance): in patients with type diabetes the progression of atherosclerosis is accelerated, as observed by the high incidence of cardiovascular events. objectives (and question): to estimate the influence of location and extent of vascular disease on new cardiovascular events in type diabetes patients. design and methods: diabetes patients (n = ), mean age years, with and without prior vascular disease were followed through - (mean follow-up years). patients with vascular disease (n = ) were classified according to symptomatic vascular location, and number (extent) of locations. we analyzed occurrence of new (non)-fatal cardiovascular events using cox proportional hazards models and kaplan-meier analysis. results: multivariate-adjusted hazard ratios (hrs) were comparable in diabetes patients with cerebrovascular disease (hr . ; % ci . - . ), coronary heart disease (hr . ; . - . ) and peripheral arterial disease (hr . ; . - . ), compared to those without vascular disease. multivariate-adjusted hr was . ; ( . - . ) in patients with one vascular location and . ; ( . - . ) in those with ‡ locations. the -year risks were respectively . % ( . - . ) and . % ( . - . ) . conclusion and discussion: diabetes patients with prior vascular disease have an increased risk of cardiovascular events, irrespective of symptomatic vascular location. cardiovascular risk increased with the number of locations. data emphasize the necessity of early and aggressive treatment of cardiovascular risk factors in diabetes patients. background (and relevance): despite recent advances in medical treatment, cardiovascular disease (cvd) is still health problem number one in western societies. a multifactorial approach with the aid of nurse practitioners (nps) is beneficial for achieving treatment goals and reducing events in patients with manifest cvd. objectives (and question): in the self-management of vascular patients activated by internet and nurses (spain) pilot study, we want to implement and test a secure personalized website with additional treatment and coaching of a np for hypertension, hyperlipidemia, diabetes mellitus, smoking and obesity in patients with clinical manifestations of cvd. design and methods: interesting patients are going to use the secure patient-specific website. before the use of the web-application, risk factors are measured. realistic treatment goal(s) for elevated risk factors based on current guidelines are made and appointments how to achieve the treatment goal(s) are determined between the patients and the np in a face to face contact. patients can enter his/ her own weight or a new blood pressure measurement for instance, besides the regular exchange information with the responding np through e-mail messages. the np personally replies as quick as possible and gives regular but protocol driven feedback and support to the patient. the risk factors are remeasured after six months. conclusion and discussion: the spain study is aimed to implement and test a patient specific website. secondary outcome is the change in cardiovascular risk profile. the pre-post measurements of risk factors and the amount of corresponding e-mail messages between the patient and the np enhances the feasibility of this innovative way of risk factor management. background (and relevance): modification of vascular risk factors has been shown to be effective in reducing mortality and morbidity in patients with symptomatic atherosclerosis. nevertheless, reduction of risk factors in clinical practice is difficult to achieve and maintain. objectives (and question): in the risk management in utrecht and leiden evaluation (rule) study, a prospective, comparative study, we assess the effects of a multidisciplinary vascular screening program on improvement of the cardiovascular risk profile and to compare this to a setting without such a program that provides current standard practice in patients referred for cardiovascular disorders. design and methods: patients with diabetes mellitus, coronary artery disease, cerebrovascular disease, or peripheral arterial disease ( per disease category in each hospital) referred by the general practitioner will be enrolled, started january . at the umcu, patients need to be enrolled in the vascular screening program or will be identified through the hospital registration system. at the lumc patients will be identified through the hospital registration system. risk factors will be measured in the two hospitals at baseline and one year after their initial visit. a risk function will be developed for this population based on data of the whole cohort. analysis will be performed on the two comparison groups as a whole, and on subgroups per disease category. changes in risk factors will be assessed with linear or logistic regression procedures, adjusting for differences in baseline characteristics between groups. conclusion and discussion: the rule study is aimed to evaluate the added value of a systematic hospital based vascular screening program on risk factor management in patients at high risk for vascular diseases. background: signs of early cerebral damage are frequently seen on mri scans in elderly people. they are related to future manifest cerebrovascular disease and cognitive deterioration. cardiovascular risk factors can only partially explain their presence and progression. evidence that inflammation is involved in atherogenesis continues to accumulate. chronic infections can act as an inflammatory stimulus. it is possible that subclinical inflammation and chronic infections play a role in the pathogenesis of early cerebral damage. objectives (and question): to unravel the role of inflammation and chronic infection in the occurrence and progression of early cerebral damage in patients with manifest vascular disease. design and methods: participants of the smart study with manifest vascular disease underwent an mr investigation of the brain between may and december . starting in january of all patients are invited for a second mr of the brain after an average follow-up period of four years. both at baseline and after follow-up all cardiovascular risk factors are measured and blood samples are stored to assess levels of inflammatory biomarkers and antibodies against several pathogens. occurrence and progression of early cerebral damage is assessed by measuring the volume of white matter lesions, the number of silent brain infarctions, cerebral atrophy, aberrant metabolic ratios measured with mr spectroscopy and cognitive function at baseline and after follow-up. the relation between inflammation, chronic infection and the occurrence and progression of early cerebral damage will be investigated using both crosssectional and longitudinal analysis. abstract monocyte chemoattractant protein (mcp- ) polymorphism and susceptibility for coro-nary collaterals j.j. regieli , , j. koerselman , ng sunanto , , m. entius , p.p. de jaegere , y. van der graaf , d.e. grobbee , p.a. doevendans heart lung institute, dept of cardiology clinical epidemiology, julius center for health sciences and primary care, utrecht, netherlands background (and relevance): collateral formation is an important beneficial condition during an acute ischemic event. a marked interindividual variability in high risk patients is seen, but at present the basis for this variability is unclear and can not be explained solely by environmental factors. a genetic factor might be present that could influence coronary collateral formation. objectives (and question): we have analyzed the association between a single nucleotide polymorphism in mcp- and the formation of coronary collaterals in patients admitted for angioplasty. mcp- has been suggested to play an important role in collateral development. design and methods: this study involved caucasian patients who were admitted for coronary angioplasty. coronary collateral development was defined angiographically as rentropgrade ‡ . polymorphisms in the promoter region of mcp- () ) were identified by pcr and allele specific restriction digestion. this method allows identification of individuals with either aa, ag or gg at mcp- position ) . statistical analysis was performed using a x -test, unconditional logistic regression, likelihood ration and a wald's test. results: we could genotype of the patients. coronary collaterals (rentropgrade > ) were found in patients. the allele frequency for aa, ag and gg was . %, . % and . %, respectively. the dis-tribution of mcp- genotypes in subjects without collaterals was in hardy weinberg equilibrium. we found that individuals with g allele ( %) were more likely to have collaterals than those with homozygous aa (or . , % ci . to . ) adjusted for potential confounders. linear regression shows that the allele g increased the likelihood for collateral presence with a factor . . conclusion and discussion: this study provides evidence for a role for genetic variation of mcp- gene in the occurrence of coronary collaterals in high risk patients. until september patients with recently established clinically manifest atherosclerotic disease with > modifiable vascular risk factors were selected for the study. the mean self-efficacy scores were calculated for vascular risk factors (age, sex, vascular disease, weight, diabetes mellitus, smoking behavior, hypercholesterolemia, hypertension, and hyperhomocysteinemia). results: diabetes, overweight, and smoking, but none of the other risk factors, were significantly associated with the level of self-efficacy in these patients. patients with diabetes had lower self-efficacy scores ( . ) for exercise and controlling weight ( . ) than patients without diabetes ( . p = . ) and ( . p = . ) respectively. overweight patients scored low on controlling weight ( . and . p< . ) and choosing healthy food ( . and . p = . ) than patients who were on a healthy weight ( . and . ). conclusion and discussion: patients with vascular diseases appear to have high levels of self-efficacy regarding medication use ( . ), exercise ( . ), and controlling weight ( . ). in patients with diabetes, overweight and in smokers, self efficacy levels were lower. practice implications: in nursing care and research on developing self-efficacy based interventions, lower self-efficacy levels can be taken into account for specific vascular patient groups. background (and relevance): little is known about the role of serum uric acid in the metabolic syndrome and increased risk of cardiovascular disease. we investigated the association between uric acid levels and the metabolic syndrome in a population of patients with manifest vascular diseases and whether serum uric acid levels conveyed an increased risk for cardiovascular disease in patients with the metabolic syndrome. design and methods: this is a nested case-cohort study of patients originating from the second manifestations of arterial disease (smart) study. all patients had manifest vascular diseases, constituting peripheral artery disease, cerebral ischemia, coronary artery disease and abdominal aortic aneurysm. analyzing the relationship of serum uric acid with the metabolic syndrome, age, sex, creatinine clearance, alcohol and diuretics were considered as confounders. investigating the relationship of serum uric acid levels with the risk for cardiovascular disease, values were adjusted for age and sex. results: the metabolic syndrome was present in % of the patients. serum uric acid levels in patients with metabolic syndrome were higher compared to patients without ( . ± . mmol/l vs. . ± . mmol/l). serum uric acid concentrations increased with the number of components of the metabolic syndrome ( . mmol/l to . mmol/l) adjusted for age, sex, creatinine clearance, alcohol and use of diuretics. increased serum uric acid concentrations showed to be independently associated with the occurrence of cardiovascular events in patients without the metabolic syndrome (age en sex adjusted hr: . , % ci . - . ) , contrary to patients with the metabolic syndrome (adjusted hr: . , % ci . - . ). conclusion: elevated serum uric acid levels are strongly associated with the metabolic syndrome, yet are not linked to an increased risk for cardiovascular disease in patients with the metabolic syndrome. however, in patients without the metabolic syndrome elevated serum uric acid levels are associated with increased risk for cardiovascular disease. the objective of this study is to investigate the overall and combined role of late-life depression, prolonged psychosocial stress exposure, and stress hormones in the etiology of hippocampal atrophy and cognitive decline. design and methods: as part of the smart study, participants with manifest vascular disease underwent an mri of the brain between may and december . in a subsample of subjects, cognitive function and depressed mood were assessed. starting in january , all patients are invited for a follow-up mri of the brain. at this follow-up measurement, minor and major depression, hypothalamic-pituitary-adrenal (hpa) axis function indicated by salivary cortisol, psychosocial stress exposure indicated by stressful life events early and later in life, and cognitive functioning will also be assessed. the independent and combined effects of late-life depression, (change in) hpa-axis activity, and psychosocial stress exposure on risk of hippocampal atrophy and cognitive decline will be estimated with regression analysis techniques adjusting for potential confounders. introduction the netherlands epidemiological society advocates according to good epidemiological practice, that research with sound research questions and good methodology should be adequately published independent of the research outcomes. although reporting bias in clinical trials is fully acknowledged, failure to report outcomes or selective reporting of outcomes in non-clinical trial epidemiological studies is less well known, but most likely occurs as well. in this mini-symposium the netherlands epidemiological society wants to give attention to this phenomenon of not publishing research outcomes, to encourage publication of all outcomes of adequate research. different scopes to this subject will be addressed: the background, an example of occurrence, initiatives to possibly avoid it and an editor's point of view. selective reporting of outcomes in clinical studies (reporting bias) has been described to occur frequently. therefore a registration of clinical trials is started which enables to address this problem in the future since occurrence of not publishing negative or adverse outcomes can be investigated with this registration. in non-clinical epidemiological studies the failure to report outcomes or selective reporting of outcomes most likely occurs as well, but is less studied and reported. again studies with negative outcomes or no associations are the ones most likely not to be reported. the most important obstacles for not publishing no or negative associations are tradition and priorities of researchers and journals. the reviewers might play a role in this as well. the netherlands epidemiological society advocates according to good epidemiological practice, that research with sound research questions and good methodology should be adequately published independent of the research outcomes. however, reality occurs not to be accordingly. therefore we would like to give attention to this phenomenon of not publishing research outcomes in non-trial-based epidemiological studies, to encourage publication of all outcomes of adequate research. in this mini-symposium, firstly the effects of failure or selective publishing of outcomes on subsequent meta-analysis in a non-clinical research setting will be demonstrated. afterwards, initiatives to promote and improve publication of observational epidemiological research will be addressed, the editor's point of view on this phenomenon will be given and finally concluding remarks will be given. background: there are several reasons for suspecting reporting bias in time-series studies of air pollution. such bias could lead to false conclusions concerning causal associations or inflate estimates of health impact. objectives: to examine time-series results for evidence of publication and lag selection bias. design and methods: all published time-series studies were identified and relevant data extracted into a relational database. effect estimates were adjusted to an increment of lg/m . publication bias was investigated using funnel plots and two statistical methods (begg, egger). adjusted summary estimates were calculated using the ''trim and fill'' method. the effect of lag selection was investigated using data on mortality from us cities and from a european multi-centre panel study of children. results: there was evidence of publication bias in a number of pollutant-outcome analyses. adjustment reduced the summary estimates by up to %. selection of the most significant lag increased estimates by over % compared with a fixed lag. conclusion and discussion: publication and lag selection bias occurs in these studies but significant associations remain. presentation and publication of time-series results should be standardised. background: selective non-publication of study outcomes hampers the critical appraisal and appropriate interpretation of available evidence. its existence could be shown empirically in clinical trials. observational research often uses an exploratory approach rather than testing specific hypotheses. results of multiple data analyses may be selected based on their direction and significance. objectives: to improve the quality of reporting of observational studies. to help avoid selective non-publication of study outcomes. methods: ''strengthening the reporting of observational studies in epidemiology (strobe)'' is an international multidisciplinary initiative that currently develops a checklist of items recommended for the reporting of observational studies (http:// www.strobe-statement.org). results: strobe recommends to avoid selective reporting of 'positive' or 'significant' study results and to base the interpretation on main results rather than on results of secondary analyses. discussion: strobe cannot prevent data dredging, but it promotes transparency at the publication stage. for instance, if multiple statistical analyses were performed in a large dataset to identify new exposure-outcome associations, authors should give details and not only report significant associations. strobe could have a ''feedback effect'' on study quality since, ideally, researchers think ahead when a study is planned and consider points that are essential for later publication. good publishing practice begins with researchers considering ( ) whether an intended study can bring added value, irrespective its result, ( ) and whether its methodology is valid to pick up positive and negative outcomes equally well. when reporting ( ) they should adequately discuss the significance of a negative result ( ) and be as eager to publish negative results as positive ones. as to editors, intentional bias in relation to study results is considered editorial malpractice, whatever its motivation. unintentional bias may be more frequent but will not easily be noticed, also by editors. editorial responsibility implies several levels (accepting for review, choice of reviewers, assess their reviews, decision making, and a repeated process in case of resubmission). various designs for process evaluation can be considered. evaluation will be more difficult for journals with few professional support. collaboration between journals can help, and may also avoid 'self evaluation bias'. in line with registering of randomized trials, registers for observational study protocols could facilitate monitoring for bias and searching unpublished results. but practicalities, methodological requirements, and bureaucratic burden should not be underestimated. in principle, in an era of electronic publishing every study can be made widely accessible widely also if not 'accepted', by editors or authors themselves. however, this would need huge changes in culture of authoring and reading, editorial practice, publishing business, and scientific openness. background: high circulating levels of insulin-like growth factor-i (igf-i), a mitogenic and anti-apoptotic peptide, have been associated with increased risk of several cancer types. objective: to study circulating levels of igf-i and igf binding protein- (igfbp- ) in relation to ovarian cancer risk. design and methods: within the european prospective investigation into cancer and nutrition (epic), we compared levels of igf-i and igfbp- measured in blood samples collected at baseline in women who subsequently developed ovarian cancer ( women diagnosed before age ) and controls. results: the risk of developing ovarian cancer before age ('premenopausal' was increased among women in the middle or top tertiles of igf-i, compared to the lowest tertile: or = . [ % ci: . - . ], and or = . [ % ci: . - . ], respectively (p trend = . ). results were adjusted for bmi, previous hormone use, fertility problems and parity. adjustment for igfbp- levels slightly attenuated relative risks. in older women we observed no association between igf-i, igfbp- and ovarian cancer risk. discussion and conclusion: in agreement with the only other prospective study in this field (lukanova et al, int j cancer, ) , our results indicate that high circulating igf-i levels may increase the risk of premenopausal ovarian cancer. background: the proportion of glandular and stromal tissue in the breast (percent breast density) is a strong breast cancer risk factor. insulin-like growth factor (igf- ) is hypothesized to influence breast cancer risk by increasing breast density. objectives: we studied the relation between premenopausal circulating igf- levels and changes in breast density over menopause. design and methods: mammograms and blood samples of premenopausal participants of the prospect-epic cohort were collected at baseline. a second mammogram was collected after these women became postmenopausal. we determined serum igf- levels. mammographic density was assessed using a computer-assisted method. changes in percent density over menopause were calculated for quartiles of igf- , using linear regression, adjusted for age and bmi. results: premenopausal percent density was not associated with igf- levels (mean percent density . in all quartiles). however, women in the highest igf- quartile showed less decrease in percent density over menopause ( st quartile: ) . vs th quartile: ) . , p-trend = . ). this was mostly explained by a stronger decrease of total breast size in women with high igf- levels. conclusion and discussion: women with high igf- levels show a lower decrease of percent density over menopause than those with low igf- levels. background: body mass index (bmi) has been found to be associated with risk of colon cancer in men, whereas weaker associations have been reported for women. reasons for this discrepancy are unclear but may be related to fat distribution or use of hormone replacement therapy (hrt) in women. objective: to examine the association between anthropometry and risk of colon cancer in men and women. design and methods: during . years of followup, we identified cases of colon cancer among , subjects free of cancer at baseline from european countries. results: bmi was significantly related to colon cancer risk in men (rr per kg/ m , . ; %-ci . - . ) but not in women (rr . ; . - . ; p interaction = . ), whereas waist-hip-ratio (whr) was equally strong related to risk in both genders (rr per . , men, . ; %-ci . - . ; women, . ; . - . ; p interaction = . ). the positive association for whr was not apparent among postmenopausal women who used hrt. conclusions: abdominal obesity is an equally strong risk factor for colon cancer in both sexes and whr is a disease predictor superior to bmi in women. the association may vary depending on hrt use in postmenopausal women; however, these findings require confirmation in future studies. background: fruits and vegetables are thought to protect against colorectal cancer. recent cohort studies, however, have not been able to show a protective effect. patients & methods: the relationship between consumption of vegetables and fruit and the incidence of colorectal cancer within epic was examined among , subjects of whom developed colorectal cancer. a multivariate cox proportional hazard model was used to determine adjusted cancer risk estimates. a calibration method based on standardized -hour dietary recalls was used to correct for measurement errors. results: after adjustment for potential confounding and exclusion of the first two years of follow-up, the results suggest that consumption of vegetables and fruits is weakly, inversely associated with risk of colorectal cancer (hr . , . , . , . , . , for quintiles of intake, % ci upper quintile . - . , p-trend . ), with each gram daily increase in vegetables and fruit associated with a statistically borderline significant % reduction in colorectal cancer risk (hr . ; . - . ). linear calibration strengthened this effect. further subgroup analyses will be presented. conclusion: findings within epic support the hypothesis that increased consumption of fruits and vegetables may protect against colorectal cancer risk. a diverse consumption of vegetables and fruit may influence the risk of gastric and oesophageal cancer. diet diversity scores (dds) were calculated within the epic cohort data from > , subjects in european countries. four scores, counting the number of ffq-based food-items usually eaten at least once in two weeks, were calculated to represent the diversity in the overall vegetable and/or fruit consumption. after an average follow-up of . years, incident cases of gastric and oesophageal cancer were observed. cox proportional hazard models were used to compute tertile specific risks, stratified by follow-up duration, gender and centre and adjusted for total consumption of vegetables and fruit and potential confounders.preliminary findings suggest that, compared to individuals who eat from only or less vegetable sub-groups, individuals who usually eat from eight different subgroups, have a reduced gastric cancer risk (hr . ; % ci . - . ). in comparison to all others, individuals who usually eat only the same fruit may experience an elevated risk (hr . ; % ci . - . ). these findings from the epic study suggest that a diverse consumption of vegetables may reduce gastric and oesophageal cancer risk. subjects with a very low diversity in fruit consumption may experience higher risk. g. steindorf , l. friedenreich , j. linseisen , p. vineis , e. riboli for the epic group german cancer research center, heidelberg, germany alberta cancer board, alberta, canada imperial college london, great-britain background: previous research on physical activity and lung cancer risk, conducted predominantly in males, has yielded inconsistent results. objectives: we examined this relationship among , men and women from the epic-cohort. design and methods: during . years of follow-up we identified men and women with incident primary lung cancer. detailed information on recreational, household and occupational physical activity, smoking habits, and diet was assessed. relative risks (rr) were estimated using cox regression. results: we did not observe an inverse association between occupational, recreational or household physical activity and lung cancer risk either in males or in females. we found a modest reduction in lung cancer risk associated with sports in males and cycling in females. for occupational physical activity, lung cancer risk was increased for unemployed men (rr = . ; % confidence interval . - . ) and men with standing occupations (rr = . ; . - . ) compared with sitting professions. conclusion: our study shows no convincing protective associations of physical activity with lung cancer risk. discussion: it may be speculated that the elevated risks for occupational physical activity could reflect the higher probability that manual workers are exposed to industrial carcinogens compared to workers having sitting/office jobs. purposes: epidemiological research almost always means using data and, increasingly, human tissue as well. the use of these resources is not free but is subject to various regulations, which differ in the european countries on several important aspects. usually these regulations have been determined without involvement of active epidemiological researchers or patient organisations. this workshop will address the issues involved in these regulations in the european context. it will serve the following purposes: -to provide arguments and tools and to exchange best practices for a way out of the regulatory labyrinths especially in cross european research projects; -to provide a platform for epidemiologists and patient groups to discuss their concerns about impediments for epidemiological research with other parties, like data protection authorities. targeted audience: the mini symposium is primarily meant for epidemiologists, but provides an excellent opportunity to meet and discuss with other stakeholders, like from patient groups, data protection authorities, the european commission etc. as well. therefore program allows for extra time for discussion. the other stakeholders will be explicitly invited. a special 'day ticket' is available to satellite symposium epidemiology and the seventh eu research framework over the last few years the seventh eu research framework has been drafted. it is now rapidly moving towards the first calls for proposals. previous eu research programmes and frameworks have been criticised because they are considered to include too few possibilities for epidemiological research and public health research. this satellite-symposium will provide an outline of the research framework and inform researchers about the current state of affairs of the seventh eu research framework. special focus will be on the possibilities for epidemiology and public health research. - . welcome by our host prof. jan willem coebergh, rotterdam, introduction, international and national regulations on the use of data and tissue or research in europe, different approaches to: evert-ben van veen l.l.m. (medlawconsult, the netherlands) -'identifiability' of data -consent for using data and tissue for research the tubafrost code of conduct to exchange data and tissue across europe. . - . data and tissuebanking for research in denmark: a liberal approach the danish approach to use patient data for epidemiological research, cooperation of the danish data protection authority, the danish act of to use anonymous but coded tissue for research based on an opt-out system, first experiences hans storm ph.d. (copenhagen, denmark) . - . estonian data protection act: a disaster for epidemiology the story of the birth of the act, implementing the european data protection directive and of its consequences reveal political and administrative incapability resulting in gradual vanishing of register-based epidemiological research. background: non-invasive assessment of atherosclerosis is important. most of the evidence of coronary calcium has been based on images obtained by electron beam ct (ebct). current data suggest that ebct and multi-slice ct (msct) give comparable results. since msct is more widely available than ebct, information on its reproducibility is relevant. objective: to assess inter-scan reproducibility of msct and to evaluate whether reproducibility is affected by different measurement protocols, slice thickness, cardiovascular risk factors and technical variables. design: cross-sectional study. materials and methods: the study population comprised healthy postmenopausal women. coronary calcium was assessed in these women twice at two separate visits using msct (philips mx idt ). images were made using . and . mm slice thickness. the agatston, volume and mass scores were assessed. reproducibility was determined by mean differences, absolute mean differences and intra-class correlation coefficients (iccc). results: the reproducibility of coronary calcium measurements between scans was excellent with iccc of > . , and small mean and absolute mean differences. reproducibilility was similar for . as for . mm slices, and equal for agatston, volume and mass measurements. conclusion: inter-scan reproducibilility of msct is excellent, irrespective of slice thickness and type of calcium parameter. background: it has been suggested that the incidence of colorectal cancer is associated with socioeconomic status (ses). the major part of this association may be explained by known lifestyle risk factors such as dietary habits. objective: to explore the association between diet and ses measured at area-based level. methods: the data for this analysis were taken from a multi-centre case-control study conducted to investigate the association between some environmental, genetic factors and colorectal cancer incidence. the townsend scores (as deprivation index) were categorized into fifths. a linear regression analysis was used to estimate difference in mean of each continuous variable of diet by deprivation fifth. results: the mean of processed meat consumption in the most deprived area was higher compared to the mean of that in the most affluent areas (mean difference = . , % ci: . , . ). by contrast, the mean of vegetables and fruits consumption in the most deprived areas was lower than that in the affluent areas. conclusion: our findings suggest that lifestyle factors are likely to be related to ses. thus any relation between ses and colorectal cancer may direct us to seek for the role of different life style factors in aetiology of this cancer. background: the reason for the apparent decline in semen quality during the past years is still unexplained. objective: to investigate the effect of exposure to cigarette smoke in utero on the semen quality in the male offspring. design and methods: in this prospective follow-up study, adult sons of mothers, who during pregnancy provided information about smoking and other lifestyle factors, are sampled in six strata according to prenatal tobacco smoke exposure. each man provides a semen sample, a blood sample, and answers a questionnaire, which is collected in a mobile laboratory. external quality assessment of semen analysis is performed twice a year. results: until now, a total of men have been included. the participation rate is %. the percentage of men with decreased sperm concentration (< mill/ml) is %. the unadjusted median ( - % percentile) sperm concentration in the non-exposed group (n = ) is ( - ) mill/ml compared to ( - ) mill/ml among men exposed to > cigarettes per day in fetal life (n = aim: to estimate the prevalence of overweight and obesity, and their effects in physical activity (pa) levels of portuguese children and adolescents aged - years. methods: the sample comprises subjects ( females- males) attending basic/secondary schools. the prevalence of overweight and obesity was calculated using body mass index (bmi), and the cut-off points suggested by cole et al. ( ) . pa was assessed with the baecke et al. ( ) questionnaire. proportions were compared using chi-square tests and means by anova. results and conclusions: overall, . % were overweight (females = . %; males = . %) and . % were obese (females = . %; males = . %). prevalence was similar across age and gender. bmi changed with age (p< . ), and a significant interaction between age and gender was found (p = . ): whereas bmi in males increased with aging, in females increased up to years and stabilized onwards. males showed significantly higher values of pa (p< . ). both genders had a tendency to increase their pa until - years. a significant interaction between age and gender (p = . ) points out different gender patterns across age: pa increased with aging in males but in females started to decline after years. no significant differences in pa were found between normal weight, overweight and obese subjects (p = . ). background: atherosclerosis is an inflammatory process. however, the relation between inflammatory markers and extent and progression of atherosclerosis remains unclear. objectives: we studied the association between c-reactive protein (crp) and established measures of atherosclerosis. design and methods: within the rotterdam study, a population-based cohort of , persons over age , we measured crp, carotid plaque and intima-media thickness (imt), abdominal artery calcification, ankle-brachial index (abi) and coronary calcification. using ancova, we investigated the relation between crp and extent of atherosclerosis. we studied the association between progression of extra coronary atherosclerosis (mean follow-up period: . years) and crp using multinomial regression analysis. results: crp levels were positively related to all measures of atherosclerosis, but the relation was weaker for measures based on detection of calcification only. crp levels were associated with severe progression of carotid plaque (multivariable adjusted odds ratio: . , % ci: . - . ), imt ( . , . - . ) and abi ( . , . - . ). no relation was observed with progression of abdominal artery calcification. conclusion and discussion: crp is related to extent and progression of atherosclerosis. the relation seems weaker for measures based on detection of calcification only, indicating that calcification of plaques might attenuate the inflammatory process. background: maternal stress during pregnancy has been reported to have an adverse influence on fetal growth. the terrorist attacks of september , on the united states have provoked feelings of insecurity and stress worldwide. objective: our aim was to test the hypothesis that maternal exposure to these acts of terrorism via the media had an unfavourable influence on mean birth weight in the netherlands. design and methods: in a prospective cohort study, we compared birth weights of dutch neonates who were in utero during the attacks with those of neonates who were in utero exactly year later. results: in the exposed group, birth weight was lower than in the non-exposed group (difference, g, %ci . , . , p = . ). the difference in birth weight could not be explained by tobacco use, maternal age, parity or other potential confounders, nor by shorter pregnancy durations. conclusion: these results provide evidence supporting the hypothesis that exposure of dutch pregnant women to the september events via the media has had an adverse effect on the birth weight of their offspring. objective: asian studies suggested potential reduction in the risk of pneumonia among patients with stroke on ace-inhibitor therapy. because of the high risk of pneumonia in patients with diabetes we aimed to assess the effects of ace-inhibitors on the occurrence of pneumonia in a general, ambulatory population of diabetic patients. methods: a case-control study was performed nested in , patients with diabetes. cases were defined as patients with a first diagnosis of pneumonia. for each case, up to controls were matched by age, gender, practice, and index date. current ace-inhibitor use was defined within a time-window encompassing the index date. results: ace-inhibitors were used in . % of , cases and in , % of , matched controls (crude or: . , % ci . to . ). after adjusting for potential confounders, ace-inhibitor therapy was associated with a reduction in pneumonia risk (adjusted or: . , % ci . to . ). the association was consistent among different relevant subgroups (stroke, heart failure, and pulmonary diseases) and showed a strong dose-effect relationship (p< . ). conclusions: use of ace-inhibitors was significantly associated with reduced pneumonia risk and may apart from blood pressure lowering properties be useful in prevention of respiratory infections in patients with diabetes. background: progressive decline in serum levels of testosterone occurs with normal aging in both men and women. this is paralleled by a decrease in physical performance and muscle strength, which may lead to disability, institutionalization and mortality. objective. we examined whether low levels of testosterone were associated with three-year decline in physical performance and muscle strength in two population-based samples of older men and women. methods: data were available for men in the longitudinal aging study amsterdam (lasa) and men and women in the health, aging, and body composition (health abc) study. levels of total testosterone and free testosterone were determined at baseline. physical performance and grip strength were measured at baseline and after three years. results: total and free testosterone were not associated with change in physical performance or muscle strength in men. in women, low levels of total testosterone (<= ng/dl) increased the risk of decline in physical performance (p = . ), and low levels of free testosterone (< pg/ ml) of decline in muscle strength (p = . ). conclusion: low levels of total and free testosterone were associated with decline in physical performance and muscle strength in older women, but not in older men. background: obesity and physical inactivity are key determinants of insulin resistance, and chronic hyperinsulinemia may mediate their effects on endometrial cancer (ec) risk. aim: to examine the relationships between prediagnostic serum concentrations of cpeptide, igf binding protein (igfbp)- and igfbp- , and ec risk. methods: we conducted a case-control study nested within the epic prospective cohort study, including incident cases of ec, in pre-and post-menopausal women, and matched control subjects. odds ratios (or) and % confidence intervals (ci) were calculated using conditional logistic regression models. results: in fasting women (> h since last meal), serum levels of c-peptide, igfbp- and igfbp- were not related to risk. however, in nonfasting women ( h or less since last meal), ec risk increased with increasing serum levels of c-peptide ( background: tobacco is the single most preventable cause of death in the world today. tobacco use primarily begins in early adolescent. objective: to estimate the prevalence and evaluate factors associated with smoking among high school going adolescents in karachi, pakistan. methods: a school based cross sectional survey was conducted in three towns of karachi from january through may . two-stage cluster sampling stratified on school types was employed to select schools and students. self-reported smoking status of school going adolescents was our main outcome in analysis. results: prevalence of smoking ( days) among adolescents was . %. multiple logistic regression model showed that after adjustment for age, ethnicity and place of residence, being student of a government school (or= . ; % ci: . - . ), parental smoking (or = . ; % ci: . - . ), uncle (or = . ; % ci: . - . ) , peer smoking (or = . ; % ci: . - . ) and spending leisure time outside home (or = . ; % ci . - . ) were significantly associated with adolescents smoking. conclusion: a . % prevalence of smoking among school going adolescents and influence of parents and peers in initiating smoking in this age group warrant the need for effective tobacco control in the country especially among the adolescents. background: individual patient data meta-analyses (ipd-ma) have been proposed to improve subgroup analyses that may provide clinically relevant information. nevertheles, comparison of the effect estimates of ipd-ma and meta-analyses of published data (map) are lacking. objective: to compare main and subgroup effect estimates of ipd-ma and map. methods: an extended literature search was performed to identify all ipd-ma of randomized controlled trials, followed by a related article search to identify maps with a similar domain, objective, and outcome. data were extracted regarding number of trials, number of subgroups, effect measure, effect estimate and their confidence intervals. results: in total ipd-ma and map could be included in the analysis. twentyfive main effect estimates could be compared; of which were in the same direction. although over subgroups were studied in both ipd-ma and map, only effect estimates could be compared; were in the same direction. subgroup analyses in map most often related to trial characteristics, whereas subgroup analyses in ipd-ma were related to patient characteristics. conclusion: comparable ipd-ma and map report similar main and subgroup effect estimates. however, ipd-ma more often study subgroups based on patient characteristics, and thus provide more clinically relevant information. patients with diabetes have an increased risk of a complicated course of community-acquired lower respiratory tract infections. although influenza vaccination is recommended for these persons, vaccination levels remain too low because of conflicting evidence regarding potential benefits. as part of the prisma nested casecontrol study among , persons recommended for vaccination, we studied the effectiveness of single and repeat influenza vaccination in the subgroup of adult diabetic population ( , ) during the - influenza a epidemic. case patients were hospitalized for diabetes, acute respiratory or cardiovascular events, or died and controls were sampled from the baseline cohort. after control for age, gender, health insurance, prior health care, medication use and co-morbid conditions logistic regression analysis showed that the occurrence of any complication ( hospitalizations, deaths) was reduced by % ( % confidence interval % to %). vaccine effectiveness was similar for those who received the vaccine for the first time and for those who received an earlier influenza vaccination. although we did not perform virological analysis or distinguish type i from type ii diabetes we conclude that patients with diabetes benefit substantially from influenza vaccination independent of whether they received the vaccine for the first time or received earlier influenza vaccinations. background: construction workers are at risk of developing silicosis. regular medical evaluations to detect silicosis preferably in the pre-clinical phase are needed. objectives: to identify the presence or absence of silicosis by developing an easy to use diagnostic model for pneumoconiosis from simple questionnaires and spirometry. design and methods: multiple logistic regression analysis was done in dutch construction workers, using chest x-ray indicative for pneumoconiosis (ilo profusion category > / ) as the reference standard (prevalence . %). model calibration was assessed with graph and the hoshmer-lemeshow goodness of fit test; discriminative ability using area under receiver operating characteristic curve (auc); and internal validity using bootstrapping procedure. results: age > years, current smoking, high exposure job title, working > years in the construction industry, 'feeling unhealthy', and standardized residual fev below ) . were selected as predictors. the diagnostic model showed a good calibration (p = . ) and discriminative ability (auc . ; % ci . to . ). internal validity was reasonable (correction factor of . and optimism corrected auc of . ). conclusions: and discussion: our diagnostic model for silicosis showed reasonable performance and internal validity. to apply the model with confidence, external validation before application in a new working population is recommended. background: artemisinin based combination therapy (act) reduces microscopic gametocytaemia, the malaria parasite stage responsible for transmission from man to mosquito. as a result, act is expected to reduce the burden of disease in african populations. however, molecular techniques recently revealed high prevalences of gametocytaemia below the microscopic threshold. our objective was to determine the importance of sub-microscopic gametocytaemia after act treatment. methods: kenyan children (n= ) aged months - years were randomised to four treatment regimens. gametocytaemia was determined by microscopy and pfs real-time nucleic acid sequence-based amplification (qt-nasba). transmission was determined by membrane feedings. findings: gametocyte prevalence at enrolment was . % ( / ) as determined by pfs qt-nasba and decreased after treatment with act. membrane feedings in randomly selected children revealed that the proportion of infectious children was up to fourfold higher than expected when based on microscopy. act did not significantly reduce the proportion of infectious children but merely the proportion of infected mosquitoes. interpretation: sub-microscopic gametocyte densities are common after treatment and contribute considerably to mosquito infection. our novel approach indicates that the effect of act on malaria transmission is much smaller than previously suggested. these findings are sobering for future interventions aiming to reduce malaria transmission. background: adequate folate intake may be important in the prevention of breast cancer. factors linked to folate metabolism may be relevant to its protective role. objectives: to investigate the association between folate intake and breast cancer risk among postmenopausal women and evaluate the interaction with alcohol and vitamin b intake. methods: a prospective cohort analysis of folate intake among , postmenopausal women from the e n french cohort who completed a validated food frequency questionnaire in was conducted. during years follow-up , cases of pathology-confirmed breast cancer were documented through followup questionnaires. nutrient intakes were categorized in quintiles and energy-adjusted using the regression-residual method. cox modelderived relative risks (rr) were adjusted for known risk factors for breast cancer. results: the multivariate rr comparing the extreme quintiles of folate intake was . ( % ci . - . ; p-trend= . ). after stratification, the association was observed only among women whose alcohol consumption was above the median (= . g/day) and among women who consumed = . lg/day of vitamin b . however, tests for interaction were not significant. conclusions: in this population, high intakes of folate were associated with decreased breast cancer risk; alcohol and vitamin b intake may modify the observed inverse association. background: the simultaneous rise in the prevalence of obesity and atopy in children has prompted suggestions that obesity might be a causal factor in the inception of atopic diseases. objective: we investigated the possible role of ponderal index (kg/m ) as marker for fatness at birth in early childhood atopic dermatitis (ad) in a prospective birth cohort study. methods: between november and november , mothers and their newborns were recruited after delivery at the university of ulm, germany. active follow-up was performed at the age of months. results: for ( %) of the children included at baseline, information on physician reported diagnosis of ad was obtained during follow-up. incidence of ad was . % at the age of one year. mean ponderal index at birth was . kg/m . risk for ad was higher among children with high ponderal index at birth (adjusted or for children within the third and fourth compared to children within the second quartile of ponderal index: . ; % ci . respectively) background: the relationship between duration of breastfeeding and risk of childhood overweight remains inconclusive, possibly in part caused by using never breastfeeding mothers as the reference category. objectives: we assessed the association between duration of breastfeeding and childhood overweight among ever breastfed children within a prospective birth cohort study. methods: between november and november all mothers and their newborns were recruited after delivery at the university of ulm, germany. active follow-up was performed at age months. results: among children ( % of children included at baseline) with available body mass index at age two ( . %) were overweight. whereas children ( . %) were never breastfed, ( . %) were breastfed for at least six months, and ( . %) were exclusively breastfed for at least six months. compared to children who were exclusively breastfed less than three months, the adjusted or for overweight was . ( % ci . ; . ) in children who were exclusively breastfed for at least three but less than six months and . ( % ci . ; . ) in children who were exclusively breastfed for at least six months. conclusion: these results highlight the importance of prolonged breastfeeding in the prevention of overweight in children. background: in africa, hiv and feeding practices influence child mortality. exclusive breastfeeding for months (bf ) and formula feeding (ff) when affordable are two who recommendations for safe feeding. objective: we estimated the proportion and the number of children saved with each recommendation at population level. design and methods: data on sub-saharan countries were analysed. we considered saved a child remaining hiv-free and alive after two years of life. a spreadsheet model based on a decision tree for risk assessment was used to calculate this number according to six scenarios that combine the two recommendations without and with promotion then with promotion and group education. results: whatever the country, the number of children saved with bf would be higher than with ff. overall, without promotion, ( background: farming has been associated with respiratory symptoms as well as protection against atopy. effects of different farming practices on respiratory health in adults have rarely been studied. objectives: we studied associations between farming practices and hay fever and current asthma in organic and conventional farmers. design and methods this cross-sectional study evaluated questionnaire data of conventional and organic farmers. associations between health effects and farm exposures were assessed by logistic regression. results: organic farmers reported slightly more hay fever than conventional farmers ( . % versus . %, p = . ). however, organic farming was no independent determinant for hay fever in multivariate models including farming practices and potential confounders. livestock farmers who grew up on a farm had a five-fold lower prevalence of hay fever than crop farmers without farm childhood (or . , % ci . - . ). use of disinfectants containing quaternary ammonium compounds was positively related to hay fever (or . , % ci . - . ). no effects of farming practices were found for asthma. conclusion and discussion: our study adds to the evidence that a farm childhood in combination with current livestock farming protects against allergic disorders. this effect was found for both organic and conventional farmers. background: although a body mass index (bmi) above kg/m is clearly associated with an increase in mortality in the general population, the meaning of high levels of bmi among physically heavily working men is less clear. methods: we assessed the association between bmi and mortality in a cohort of male construction workers, aged - years, who underwent an occupational health examination in wu¨rttemberg (germany) during - and who were followed over a years period. covariates considered in the proportional hazard regression analysis included age, nationality, smoking status, alcohol consumption, and comorbidity. results: during the follow-up deaths occurred. there was a strong u-shaped association between bmi and all-cause mortality, which was lowest for bmi levels between and kg/m . this pattern persisted after exclusion of the first years of follow-up and control for multiple covariates. compared with men with a bmi < . kg/m , the relative mortality was . ( % confidence interval: , - , ), . ( . - . ) and . ( . - . ) for bmi ranges - . , - . and = . kg/m . conclusion and discussion: bmi levels commonly considered to reflect overweight or moderate obesity in the general population may be associated with reduced mortality in physically heavily working men. background: colonoscopy with removal of polyps may strongly reduce colorectal cancer (crc) incidence and mortality. empirical evidence for optimal schedules for surveillance is limited. objective. to assess risk of proximal and distal crc after colonoscopy with polypectomy. design and methods: history and results of colonoscopies were obtained from cases and controls in a population-based case-control study in germany. risk of proximal and distal crc according to time since colonoscopy was compared to risk of subjects without previous colonoscopy. results: subjects with previous detection and removal of polyps had a much lower risk of crc within four years after colonoscopy (adjusted odds ratio . , % confidence interval . - . ), and a similar risk as those without colonoscopy in the long run. within four years after colonoscopy, risk was particularly low if only single or small adenomas were detected. most cancers occurring after polypectomy were located in the proximal colon, even if polyps were found in the sigma or rectum only. conclusion and discussion: our results support suggestions that surveillance colonoscopy after removal of single and small adenomas may be deferred to five years and that surveillance should include the entire colorectum even if only distal polyps are detected. background: a population-based early detection programme for breast cancer has been in progress in finland since . recently, detailed information about actual screening invitation schemes in - has become available in electronic form, which enables more specific modeling of breast cancer incidence. objectives: to present a methodology for taking into account historical municipality-specific schemes of mass screening when constructing predictions for breast cancer incidence. to provide predictions for numbers of new cancer cases and incidence rates according to alternative future screening policies. methods: observed municipality-specific screening invitation schemes in finland during - were linked together with breast cancer data. the incidence rate during the observation period was analyzed using poisson regression, and this was done separately for localized and nonlocalized cancers. for modeling, the screening programme was divided into seven different phases. alternative screening scenarios for future mass-screening practices in finland were created and an appropriate model for incidence prediction was defined. results and conclusion: expanding the screening programme would increase the incidence of localized breast cancers; the biggest increase would be obtained by expanding from women aged - to - . the impacts of changes in the screening practices on predictions for non-localized cancers would be minor. background: new screening technologies are implemented to routine screening in increasing numbers, with limited evidence on their effectiveness. randomised evaluation of new technologies is encouraged but rarely done. objective: to evaluate in a randomised design whether the effectiveness of an organised cervical screening programme can be improved by means of new technologies. methods: since , - , women have been invited annually to a randomised multi-arm trial ran within the finnish organised cervical screening programme. the invited women are randomly allocated to three study arms of different primary screening tests: conventional cytology, automation-assisted cytology and, since , human papillomavirus (hpv) testing. up to , we have gathered information on , screening visits in the automation-assisted arm and , in the hpv arm, and we have compared the results to conventional screening. results: automation-assistance resulted in a slightly increased detection of precancers, but the efficacy based on interval cancers is not known. results on hpv screening suggest higher detection of precancers and cancers compared to conventional screening. conclusion: evidence of higher effectiveness of new screening technologies is needed, especially when changing the existing screening programmes. the multi-arm trial shows how these technologies can be implemented to routine in a controlled manner. introduction: nodules and goitres are important risk factors for thyroid cancer. as the number of diagnosed cases of thyroid cancer is increasing, the incidence of such risk factors has been assessed in a french cohort of adults. methods: the su.vi.max (supple´mentation en vitamines et mine´raux antioxydants) cohort study included middle-aged adults followed-up during eight years. incident cases of goitres and nodules have been identified retrospectively by scheduled clinical examinations and spontaneous consultations by the participants. cox proportional hazards modeling was used to identify factors associated to thyroid diseases. results: finally, incident cases of nodules and goitres were identified among , subjects free of thyroid diseases at inclusion. after an average follow-up of years, the incidence of goitres and nodules was . % in - year old men, . % in - year old women and . % in - year old women. identified associated factors were age, low urinary thiocyanate level and oral contraceptive use in women, and high urinary thiocyanate level and low urinary iodine level in men. conclusion: estimated incidences are consistent with those observed in other countries. the protective role of urinary thiocyanate in both men and women and, in women, oral contraceptives deserve further investigation. background: various statistical methods for outbreak detection in hospital settings have been proposed in the literature. usually validation of those methods is difficult, because the long time series of data needed for testing the methods are not available. modeling is a tool to overcome that difficulty. objectives: to use model generated data for testing sensitivity and specificity of different outbreak detection methods. methods: we developed a simple stochastic model for a process of importation and transmission of infection in small populations (hospital wards). we applied different statistical outbreak detection methods described in the literature to the generated time series of diagnosis data and calculated and the sensitivity and specificity of different methods. results: we present roc curves for the different methods and show how they depend on the underlying model parameters. we discuss how sensitivity and specificity measures depend on the degree of underdiagnosis, on the ratio of admitted colonised patients to colonisation resulting from transmission in the hospital, and on the frequency of testing patients for colonisation. conclusions: modeling can be a useful tool for evaluating statistical methods of outbreak detection especially in situation where real data is scarce or its quality questionable. associated with higher mammographic density and breast pain, has been increased which has bearing on screening performance. objective: we compared the screening performance for women aged - years with dense and lucent breast patterns in two time periods and studied the possible interaction with use of hrt. methods: data were collected from a dutch regional screening programme for women referred in - (n = ) and - (n = ) . in addition, we sampled controls for both periods that were not referred (n = and n = resp.) and women diagnosed with an interval cancer. mammograms were digitised and computer-assisted methods used to measure mammographic density. among other parameters, sensitivity was calculated to describe screening performance. results: screening performance has improved slightly, but the difference between dense and lucent breast patterns still exists (e.g. sensitivity % vs. %). hrt use has increased; sensitivity was particularly low ( %) in the group of women with dense breast patterns on hrt. discussion: in conclusion, the detrimental effect of breast density and the interaction with hrt on screening performance warrants further research with enlargement of the catchment area, more referred women, interval cancers and controls. background: population based association studies might lead to false-positive results if possibly underlying population structure is not adequately accounted for. to assess the nature of the population structure some kind of cluster analysis has to be carried out. we investigated the use of self-organizing maps (soms) for this purpose. objectives: the two main questions concern identification of an either discrete or an admixed population structure and identification of the number of subpopulations involved in forming the structured population under investigation. design and methods: we simulated data sets with different population models and included varying informative marker and map sizes. sample sizes ranged from to individuals. results: we found that a discrete structure can easily be accessed by soms. a near to perfect assignment of individuals to their population of origin can be obtained. for an admixed population structure though, soms do not lead to reasonable results. here, even the correct number of subpopulations involved can not be identified. conclusion: in conclusion, soms can be an alternative to a model-based cluster analysis if the researcher assumes a discrete structure but should not be applied if an admixed structure is likely. background: little is known about the combined effect of duration of breastfeeding, sucking habits and malocclusion in the primary dentition. objectives: we studied the association of breastfeeding and non-nutritive sucking habits on malocclusion on the primary dentition. design and methods: a cross-sectional study nested in a birth cohort was carried out in pelotas, brazil. a random sample of children aged was examined and their mothers interviewed. the foster and hamilton criteria were used to define anterior open bite (aob) and posterior cross bite (pcb). information regarding breastfeeding and non-nutritive sucking habits was collected from birth to years-old. poisson's regression analysis was used. results: non-nutritive sucking habits between months and years of age (pr . [ . ; . ] ) and digital sucking at years of age (pr . [ . ; . ]) were risk factors for aob. breastfeeding for less than months (pr . [ . ; . ] ) and the regular use of a pacifier between months and years of age (pr . [ . ; . ]) were the risk factors for pcb. for pcb an interaction was identified between lack of breastfeeding and the use of a pacifier. conclusion: lack of breastfeeding and longer non-nutritive sucking habits during early childhood were the main risk factors for malocclusion in primary dentition. background: recent, dramatic coronary heart disease (chd) mortality increases in beijing, can be mostly explained by adverse changes in risk factors, particularly total cholesterol and diabetes. it is important for policy making to predict the impact of future changes in risk factors on chd mortality trends. objective: to assess the potential impact of changes in risk factors on numbers of chd deaths in beijing from to , to provide evidence for future chd strategies. design: the previously validated impact model was used to estimate the chd deaths expected in a) if recent risk factor trends continue or b) if levels of risk factors reduce. results: continuation of current risk factor trends will result in a % increase in chd deaths by , (almost half being attributable to increases in total cholesterol levels). even optimistically assuming a % annual decrease in risk factors, chd deaths would still rise by % because of population ageing. conclusion: a substantial increase in chd deaths in beijing may be expected by . this will reflect worsening risk factors compounded by demographic trends. population ageing in china will play an important role in the future, irrespective of any improvements in risk factor profiles. background: since smoking cessation is more likely during pregnancy than at other times, interventions to maintain quitting postpartum may give the best opportunity for a long-time abstinence. it is still not clear what kind of advice or counseling should be given to help prevent the relapse postpartum. objectives: to identify the factors, which predispose women to smoking relapse after delivery. design and methods: the cohort study was conducted in and in public maternity units in lodz, poland. the study population consisted of pregnant women between - weeks of pregnancy who have quit smoking no later than three months prior to participation in the study. smoking status was verified using saliva cotinine level. women were interviewed twice: during pregnancy and three months after delivery. results: within three months after delivery about half of women relapsed into smoking. the final model identified the following risk factors for smoking relapse: having partner and friends who smoke, quitting smoking in late pregnancy, and negative experiences after quitting smoking such as dissatisfaction with weight, nervousness, irritation, loosing pleasure. conclusion. this study advanced the knowledge of the factors that determine smoking relapse after delivery and provided preliminary data for future interventions. introduction: it remains difficult to predict the effect of an particular antihypertensive drug in an individual patient and pharmacogenetics might optimise this. objective: to investigate whether the association between use of angiotensin converting enzyme (ace)-inhibitors or ß-blockers and the risk of stroke or myocardial infarction (mi) is modified by the t-allele of the angiotensinogen m t polymorphism. methods: data were used from the rotterdam study, a population-based prospective cohort study. in total, subjects with hypertension were included from july st, onwards. follow-up ended at the diagnosis of mi or stroke, death, or the end of study period (january st, ) . the drug-gene interaction and the risk of mi/stroke was determined with a cox proportional hazard model (adjusted for each drug class as time-dependent covariates). results: the interaction between current use of ace-inhibitors and the angiotensinogen m t polymorphism increased the risk of mi (synergy index (si) = . ; % ci: . - . ) and non-significant increased risk of stroke (si = . ; % ci: . - . ). no interaction was found between current use of ß-blockers and the agt m t polymorphism on the risk of mi or stroke. conclusion: subjects with at least one copy of the t allele of the agt gene might have less benefit from ace-inhibitor therapy. [ . - . ] to . [ . - . ] in those without ms-idf and . [ . - . ] with ms-idf. ms-ncep had no effect. conclusion and discussion: although cardiovascular disease was self-reported, we conclude that the higher prevalence of cardiovascular disease is partly accounted for by marked differences in the prevalence of metabolic syndrome. the ms-idf criteria seem better for defining metabolic syndrome in ethnic groups than the ms-ncep criteria. background: selenium is an essential trace mineral with antioxidant properties. objective: to perform meta-analyses of the association of selenium levels with coronary heart disease (chd) endpoints in observational studies and the efficacy of selenium supplements in preventing chd in randomized controlled trials. methods: we searched medline and the cochrane library from through . relative risk (rr) estimates were pooled using an inversevariance weighted random-effects model. for observational studies reporting three or more categories of exposure we conducted a dose-response meta-analysis. results: twenty-five observational studies and clinical trials met our inclusion criteria. the pooled rr comparing the highest to the lowest categories of selenium levels was . ( % confidence interval . - . ) in cohort studies and . ( . - . ) in case-control studies. in dose-response models, a % increase in selenium levels was associated with a % ( - %) reduced risk of coronary events. in randomized trials, the rr comparing participants taking selenium supplements to those taking placebo was . ( . - . ). conclusion: selenium levels were inversely associated with the risk of chd in observational studies. the randomized trials findings are still inconclusive. these results require confirmation in randomised controlled trials. currently, selenium supplements should not be recommended for cardiovascular prevention. background propensity score analysis (psa) can be used to reduce confounding bias in pharmacoepidemiologic studies of the effectiveness and safety of drugs. however, confidence intervals may be falsely precise because psa ignores uncertainty in the estimated propensity scores. objectives: we propose a new statistical analysis technique called bayesian propensity score analysis (bpsa). the method uses bayesian modelling with the propensity score as a latent variable. our question is: does bpsa yield improved interval estimation of treatment effects compared to psa? our objective is: to implement bpsa using computer programs and investigate the performance of bpsa compared to psa. design and methods: we investigated bpsa using monte carlo simulations. synthetic datasets, of sample size n = , , , were simulated by computer. the datasets were analyzed using bpsa and psa and we estimated the coverage probability of % credible intervals. results the estimated coverage probabilities ranged from % to % for bpsa, and from % to % for psa, with simulation standard errors less than %. background: several factors associated with low birth weight, such as smoking and body mass index (bmi) do not explain all ethnic differences. this study investigates the effects of working conditions on birth weight among different ethnic groups. methods: questionnaire data, filled in weeks after prenatal screening, was used from the amsterdam born children and their development (abcd) study (all pregnant women in amsterdam [ / / - / / (n = . ), response ( %)]. ethnicity (country of birth). was dichotomised into dutch and non-dutch. working conditions were: weekly working hours, weekly hours standing/walking, physical load and job-strain (karasek-model). only singleton deliveries with pregnancy duration = weeks were included. results: although only . % of the non-dutch women worked during first trimester ( . % of the dutch women), they reported significantly more physical load ( . % vs . %), more hours standing/walking ( . % vs . %) and more high job-strain ( . vs . ). linear regression revealed that only high job-strain lowered significantly birth weight (non-dutch: gram and dutch: gram). after adjusting for confounders (gender, parity, smoking, maternal length, maternal bmi and education), this was only significant in the non-dutch group ( vs. gram). conclusion: job-strain has more effect on birth weight in non-dutch compared to dutch women. background: in panama population was estimated in . million habitants, from which three millions lived in malaria endemic areas. until january malaria control activities were accomplished under a vertical structure. objective: to evaluate the evolution of malaria control in panama, before and after the decentralization of the malaria program. design and methods: average (standard deviation) of the program indexes are described for the last decades. the correlation between positive smears index and per capita cost of the program is analyze. results: in the 's the average (standard deviation) positive smears index per habitants was . % ( . ); in the 's: . % ( . ); in the 's: . % ( . ); in the 's: . % ( . ); and in the first five years of : . % ( . ). after the decentralization of the program was accomplished in , the positive smears index increased . fold. the average per capita cost involved in malaria control activities per decade ranged between . y . us dollars and presented a determination coefficient of . in the reduction of the positive smears index. discussion: the decentralization had significant detrimental implications in the control program capabilities. background: notification rates of new smear-positive tuberculosis in the central mountainous provinces ( / , population) are considerably lower than in vietnam in general ( / , population). this study assessed whether this is explained by low case detection. objective: to assess the prevalence and case detection of new smear-positive pulmonary tuberculosis among adults with a prolonged cough in central mountainous vietnam. design and methods: a house-to-house survey of adults years or older was carried out in randomly selected districts in three mountainous provinces in central vietnam in . three sputum specimens were microscopically examined of persons reporting a cough of weeks or longer. results: the survey included , persons with a response of %. a cough of weeks or longer was reported by , ( . % % ci . - . ) persons. of these, were sputum smear-positive of whom had had anti-tuberculosis treatment. the prevalence of new smear-positive tuberculosis was / , population ( % ci - / , population). the patient diagnostic rate was . per person-year, suggesting that the case notification rate as defined by who was %. conclusion: low tuberculosis notification rates in mountainous vietnam are probably due to low tuberculosis incidence. explanations for low incidence at high altitude need to be studied. background: although patients with type diabetes (dm ) have an increased risk of urinary tract infections (utis), not much is known about predictors of a complicated course. objective: this study aims to develop a prediction rule for complicated utis in dm patients in primary care. design and methods: we conducted a -month prospective cohort study, including dm patients aged years or older from the second dutch national survey of general practice. the combined outcome measure was defined as the occurrence of recurrent cystitis, or an episode of acute pyelonephritis or prostatitis. results: of the , dm patients % was male and mean age was years (sd ). incidence of the outcome was per patient years (n = ). predictors were age, male sex, number of physician contacts, incontinence of urine, cerebro vascular disease or dementia and renal disease. the area under the receiver-operating curve (auc) was . ( % ci . to . ). subgroup analyses for gender showed no differences. there is an increased early postoperative mortality (operation risk) after elective surgery. this mortality is normally associated with cardiovascular events, such as deep venous thrombosis, pulmonary embolism, and ischemic heart diseases. our objective was to quantify the magnitude of the increased mortality and how long the mortality after an operation persists. we focused on the early postoperative mortality after surgery for total knee and total hip replacements from the national registries in australia and norway, which cover more than % of all operations in the two nations. only osteoarthritis patients between and years of age were included. a total of . patients remained for analyses. smoothed intensity curves were calculated for the early postoperative period. effects of risk factors were studied using a nonparametric proportional hazards model. the mortality was highest immediately after the operation ($ deaths per . patients per day), and it decreased until the rd postoperative week. the mortality was virtually the same for both nations and both joints. mortality increased with age and was higher for males than for females. a possible reduction of early postoperative mortality is plausible for the immediate postoperative period, and no longer than the rd postoperative week. background/objectives: single, modifiable risk factors for stroke have been extensively studied before, but their combined effects were rarely investigated. aim of the present study was to assess single and joint effects of risk factors on stroke and transitoric ischemic attack (tia) incidence in the european prospective investigation into cancer and nutrition (epic)-potsdam study. methods: among participants aged - years at baseline total stroke cases and tia cases occurred during . years of follow-up. relative risks (rr) for stroke and tia related to risk factors were estimated using cox proportional hazard models. results: after adjustment for potential confounders rr for ischemic stroke associated with hypertension was . ( % ci, . - . ) and for tia . ( % ci . - . ). the highest rr for ischemic stroke (rr . , % ci . - . , p trend< . ) and tia (rr . , % ci . - . , p trend= . ) were observed among participants with or modifiable risk factors. . % of ischemic strokes and . % of tia cases were attributable to hypertension, diabetes mellitus, high alcohol consumption, hyperlipidemia, and smoking. conclusion: almost % of ischemic stroke cases could be explained by classical modifiable risk factors. however, only one in four tia cases was attributable to those risk factors. background: the investigation of genetic factors is gaining importance in epidemi-ology. most relevant from a public health perspective are complex diseases that are characterised by complex pathways involving gene-gene-and gene-environment-interactions. the identification of such pathways requires sophisticated statistical methods that are still in their infancy. due to their ability in describing complex association structures, directed graphs may represent a suitable means for modelling complex causal pathways. objectives: we present a study plan to investigate the appropriateness for using directed graphs for modelling complex pathways in association stud-ies. design and methods: graphical models and artificial neural networks will be investigated using simulation studies and real data and their advantages and disadvantages of the respective ap-proaches summed up. furthermore, it is planned to construct a hybrid model exploiting the strengths of either model type. results and conclusions: the part of the project that concerns graphical models is being funded and ongoing. first results of a simulation study have been obtained and will be presented and discussed. a second project is currently being applied for. this shall cover the investigation of neural networks and the construction of the hybrid model. this study investigates variations in mortality from 'avoidable' causes among migrants in the netherlands in comparison with the native dutch population. data were obtained from population and mortality registries in the period - . we compared mortality rates for selected 'avoidable' conditions for turkish, moroccan, surinamese and antillean/aruban groups to native dutch. we found slightly elevated risk in total 'avoidable' mortality for migrant populations (rr = . ). higher risks of death among migrants were observed from almost all infectious diseases (most rr> . ) and several chronic conditions including asthma, diabetes and cerebro-vascular disorders (most rr> . ). migrant women experienced a higher risk of death from maternity-related conditions (rr = . ). surinamese and antillean/ aruban population had a higher mortality risk (rr = . and . respectively), while turkish and moroccans experienced a lower risk of death (rr = . and . respectively) from all 'avoidable' conditions compared to native dutch. control for demographic and socioeconomic factors explained a substantial part of ethnic differences in 'avoidable' mortality. conclusion: compared to native dutch, total 'avoidable' mortality was slightly elevated for all migrants combined. mortality risks varied greatly by cause of death and ethnicity. the substantial differences in mortality for a few 'avoidable' conditions suggest opportunities for improvement within specific areas of the healthcare system. warmblood horses scored by the jury as having uneven feet will never pass yearly selection sales of the royal dutch warmblood studbook (kwpn).to evaluate whether the undesired trait 'uneven feet' influences performance, databases of kwpn (n = horses) and knhs (n = show jumpers, n = dressage horses) were linked through the unique number of each registered horse. using a proc glm model of sas was investigated whether uneven feet had effects on age at first start and highest performance level. elite show jumpers with uneven feet start at . years and dressage horses . years of age, which is a significant difference (p< . ) with elite even feet horses ( . respectively . years). at their maximum level of performance horses with even feet linearly scored in show jumping . at regular and . at elite level ( . resp. . with uneven feet), while in dressage horses scores were . at regular and . at elite level ( . resp. . with uneven feet).the conformational trait 'uneven feet' appears to have a significant effect on age at first start, while horses with even feet demonstrate a higher maximal performance than horses with uneven feet. objectives: to identify children with acute otitis media (aom) who might benefit more from treatment with antibiotics. methods: an individual patient data meta-analysis (ipdma) on six randomized trials (n = children). to preclude multiple testing, we first performed a prognostic study in which predictors of poor outcome were identified. subsequently, interactions between these predictors and treatment were studied by fixed effect logistic regression analyses. only if a significant interaction term was found, stratified analyses were performed to quantify the effect in each subgroup. results: interactions were found for: age and bilateral aom, and otorrhea. in children less than years with bilateral aom, a rate difference (rd) of ) % ( % ci ) ; ) %) was found, whereas in children aged years or older with unilateral aom the rd was ) % ( % ci ) ; ) %). in children with and without otorrhea the rd were ) % ( % ci ) ; ) %), and ) % ( % ci ) %; ) %). conclusion: although there still are many areas in which ipdma can be improved, using individual patient data appear to have many advantages especially in identifying subgroups. in our example, antibiotics are beneficial in children aged less than years with bilateral aom, and in children with otorrhea. major injuries, such as fractures, are known to increase the risk of venous thrombosis (vt). however, little is known of the risk caused by minor injuries, such as ankle sprains. we studied the risk of vt after minor injury in a population-based case-control study of risk factors for vt, the mega-study. consecutive patients, enrolled via anticoagulation clinics, and control subjects, consisting both of partners of patients and randomly selected control subjects, were asked to participate and filled in a questionnaire. participants with cancer, recent plastercasts, surgery or bedrest were excluded from the current analyses. out of patients ( . %) and out of controls ( . %) had suffered from a minor injury resulting in a three-fold increased risk of vt (odds ratio adjusted for age and sex . ; % confidence interval . - . ) compared to those without injury. the risk was highest in the first month after injury and was no longer increased after months. injuries located in the leg increased the risk five-fold, while those located in other body parts did not increase the risk. these results show that minor injuries in the leg increase the risk of vt. this effect appears to be temporary and mainly local. introduction: in southeast asia, dengue was considered a childhood disease. in the americas, this disease occurs predominantly in older age groups, indicating the need for studies to investigate the immune status of the child population, since the presence of antibodies against a serotype of this virus is a risk factor for dengue hemorrhagic fever (dhf). objective: to evaluate the seroprevalence and seroincidence of dengue in children living in salvador, bahia, brazil. methods: a prospective study was carried out in a sample of children of - years by performing sequential serological surveys (igg/ dengue). results: seroprevalence in children was . %. a second survey (n = seronegative children) detected an incidence of . % and no difference was found between males and females or according to factors socioeconomic analyzed. conclusion and discussion: these results show that, in brazil, the dengue virus circulates actively in the initial years of life, indicating that children are also at great risk of developing dhf. it is possible that in this age group, dengue infections are mistaken for other febrile conditions, and that there are more inapparent infections in this age group. therefore, epidemiological surveillance and medical care services should be aware of the risk of dhf in children. since , in the comprehensive cancer centre limburg (cccl) region, all women aged - years are invited to participate in the cervical cancer screening programme once every five years. we had the unique opportunity to link data from the cervical screening programme and the cancer registry. we studied individual pap smear testing and participation in the screening programme preceding the diagnosis of cervical cancer. all invasive cases of cervical cancer of women aged - years in the period - were selected. subgroups were based on results of the pap smear and invitation and participation in the screening programme. time interval between screening and detection of tumours was calculated. in - , the non-response rate was %. in total, invasive cervical cancer cases were detected of which were screening and interval carcinomas. in the group of women who were invited but did not participate and women who were not invited, respectively and tumours were detected. these tumours had a higher stage compared to screening carcinomas. in the cccl region, more and higher stage tumours were found in women who did not participate in the screening compared to women with screening tumours. background: pcr for mycobacterium tuberculosis (mtb) has already proved to be a useful tool for the diagnosis and investigation of molecular epidemiology. objectives: evaluation of pcr assay for detection of mycobacterium tuberculosis dna as a diagnostic aid in cutaneous tuberculosis. design and methods: thirty paraffinembedded samples belonging to patients were analyzed for acid fast bacilli. dna was extracted from tissue sections and pcr was performed using specific primers based on is repeated gene sequence of mtb. results: two of the tissue samples were positive for acid fast bacilli (afb). pcr was positive in eight samples from six patients. amongst them, two were suspected of having lupus vulgaris confirmed histopathologically, whom their entire tests were positive. accounting histopathology as gold standard, the sensitivity of pcr in this study was determined as %. conclusion: from cases of skin tuberculosis diagnosed by histopathology, were positive by pcr technique, which shows the priority of previous method to molecular technique. discussion: pcr assay can be used for rapid detection of mtb from cutaneous tuberculosis cases, particularly when staining for afb is negative and there is a lack of growth on culture or when fresh material has not been collected for culture. background: recent epidemiological studies used automated oscillometric blood pressure (aod) devices that systematically measure higher blood pressure values than random zero sphygmomanometer devices (rzs) hampering the comparability of the blood pressure values between these studies. we applied both a random zero and an automated oscillometric blood pressure device in a randomized order in an ongoing cohort study. objectives: the aim of this analysis was to compare the blood pressure values by device and to develop a conversion algorithm for the estimation of blood pressure values from one device to the other. methods: within a randomized subset of subjects aged - years, each subject was measured three times by each device (hawskley random zero and omron hem- cp) in a randomized order. results: the mean difference (aod-rzs) between the devices was . mmhg and . mmhg for the systolic and diastolic blood pressure respectively. linear regression models including age, sex, and blood pressure level can be used to convert rzs blood pressure values to aod blood pressure values and vice versa. conclusions: the results may help to better compare blood pressure values of epidemiological studies that used different blood pressure devices. a form was used to collect relevant perinatal clinical data, as part of a european (mosaic) and italian (action) project. the main outcomes were mortality and a variable combining mortality and severe morbidity at discharge. the cox proportional hazards and logistic regression models were used, respectively, for the two outcomes. results: twenty-two of percent of vpbs were among fbms. comparing to control group, the percentage of babies below weeks and plurality was statistically significant higher among babies of fbms: % vs. . and . % vs. . %. adjusting for potential confounders, no association for mortality among immigrant group was found, whereas a slightly excess of morbidity-mortality was observed (odd ratio, . ; % cis . - . ). conclusions: the high proportion of vpbs among fbms and the slight excess observed in morbidity and mortality indicate the need to improve the health care delivery for the immigrant population. background: high-risk newborns have excess mortality, morbidity and use of health services. objectives: to describe re-hospitalizations after discharge from an italian region. design and methods: the population study consisted of all births with < weeks' gestation discharged alive from the twelve neonatal intensive care units in lazio region during . the perinatal clinical data was collected as part of a european project (mosaic). we used the regional hospital discharge database to find hospital admissions within months, using tax code for record linkage. data were analyzed through logistic regression for re-hospitalization. results: the study group included children; among these, ( . %) were re-hospitalized; overall, readmission were observed. the median total length of stay for re-admissions was d. the two most common reasons for re-hospitalization were respiratory ( . %) and gastrointestinal ( . %) disorders. the presence of a severe morbidity at discharge (odd ratio . : % cis . - . ) and male sex (odd ratio . ; % cis . - . ) predicted re-hospitalization in multivariate model. conclusions: almost one out three preterm infants was re-hospitalized in the first months. readmissions after initial hospitalization for a very preterm birth could be a sensitive indicator of quality of follow-up strategies in high risk newborns. background: self-medication with antibiotics may lead to inappropriate use and increase the risk of selection of resistant bacteria. in europe the prevalence varies from / to / respondents. self-medication may be triggered by experience with prescribed antibiotics. we investigated whether in european countries prescribed use was associated with self-medication with antibiotics. methods: a population survey was conducted in european countries with respondents completing the questionnaire. multivariate logistic regression analysis was used to study the relationship between prescribed use and self-medication (both actual and intended) in general, for a specific symptom/disease or a specific antibiotic. results: prescribed use was associated with selfmedication, with stronger effect in northern/western europe (odds ratio . , % ci . - . ) than in southern ( . , . - . ) and eastern europe ( . , . - . ). prescribing of a specific antibiotic increased the probability of self-medication with the same antibiotic. prescribing for a specific symptom/disease increased the likelihood of self-medication for the same symptom/disease. the use of prescribed antibiotics and actual self-medication were both determinants of intended self-medication in general and for specific symptoms/diseases. conclusions: routine prescribing of antibiotics increases the risk of self-medication with antibiotics for similar ailments, both through the use of leftovers and buying antibiotics directly from pharmacies. background: in the american national kidney foundation published a guideline based on opinion and observational studies which recommends tight control of serum calcium, phosphorus and calcium-phosphorus product levels in dialysis patients. objectives: within the context of this guideline, we explored associations of these plasma concentrations with cardiovascular mortality risk in incident dialysis patients. design and methods: in necosad, a prospective multi-centre cohort study in the netherlands, we included consecutive patients new on haemodialysis or peritoneal dialysis between and . risks were estimated using adjusted time-dependent cox regression models. results: mean age was ± years, % was male, and % was treated with haemodialysis. cardiovascular mortality risk was significantly higher in haemodialysis patients (hr: . ; % ci: . to . ) and in peritoneal dialysis patients (hr: . ; . to . ) with elevated plasma phosphorus levels when compared to patients who met the target. in addition, having elevated plasma calcium-phosphorus product concentrations increased cardiovascular mortality risk in haemodialysis (hr: . ; . to . ) and in peritoneal dialysis patients (hr: . ; . to . ). conclusion: application of the current guideline in clinical practice is warranted since it reduces cardiovascular mortality risk in haemodialysis and peritoneal dialysis patients in the netherlands. background: urologists are increasingly confronted with requests for early detection of prostate cancer in men from hereditary prostate cancer (hpc) families. however, little is known about the benefit of early detection among men at increased risk. objectives: we studied the effect of biennial screening with psa in unaffected men from hpc families, aged - years, on surrogate endpoints (test and tumour characteristics). methods: the netherlands foundation for the detection of hereditary tumours holds information on approximately hpc families. here, nonaffected men from these families were included and invited for psa testing every years. we collected data on screening history and complications related to screening. results: in the first round, serum psa was elevated ( ng/ml or greater) in of men screened ( %). further diagnostic assessment revealed patients with prostate cancer ( . %). compared to population-based prostate cancer screening trials, the referral rate is equal but the detection rate is twice as high. discussion: in conclusion, the results of prostate cancer screening trials will not be directly applicable to screening in hpc families. the balance between costs, side-effects and potential benefits of screening when applied to a high-risk population will have to be assessed separately. background: in industrialized countries occupational tuberculosis among health care workers (hcws) is re-emerging as a public health priority. to prevent and control tuberculosis transmission in nosocomial settings, public health agencies have issued specific guidelines. turin, the capital of the piedmont region in italy, is experiencing a worrying rise of tuberculosis incidence. here, hcws are increasingly exposed to the risk of nosocomial tuberculosis transmission. objectives: a) to estimate the sex-and age-adjusted annual rate of tuberculosis infection (arti) (per person-years [%py]) among the hcws, as indicated by tuberculin skin test conversion (tst) conversion, b) to identify occupational factors associated with significant variations in the arti, c) to investigate the efficacy of the regional preventive guidelines. design and methods: multivariate survival analysis on tst conversion data from a dynamic cohort of hcws in turin, between and . results: the overall estimated arti was . ( % ci: . - . ) %py. the risk of tst conversion significantly differed among workplaces, occupations, and age of hcws. the guidelines implementation was associated with an arti reductions of . ( % ci: . - . ) %py. conclusions: we identify occupational risk categories for targeting surveillance and prevention measures and assessed the efficacy of the local guidelines. background: a positive family history (fh) of breast cancer is an established risk factor for the disease. screening for breast cancer in israel is recommended annually for positive-fh women aged = y and biennially for average-risk women aged - y. objective: to assess the effect of having a positive breast cancer fh on performing screening mammography in israeli women. methods: a cross-sectional survey based on a random sample of the israeli population. the study population consists of , women aged - y and telephone interviews were used. logistic regression models identified variables associated with mammography performance. results: a positive fh for breast cancer was reported by ( . %) participants. performing a mammogram in the previous year was reported by . % and . % of the positive and negative fh subgroups, respectively (p< . ). rates increased with age. among positive fh participants, being married was the only significant correlate for a mammogram in the previous year. conclusions: over % and around % of high-risk women aged - y and = y, respectively, are inadequately screened for breast cancer. screening rates are suboptimal in average-risk women too. discussion: national efforts should concentrate on increasing awareness and breast cancer screening rates. to evaluate the association between infertility, infertility treatments and breast cancer risk. methods: a historical prospective cohort with , women who attended israeli infertility centers between and . their medical charts were abstracted. breast cancer incidence was determined through linkage with the national cancer registry. standardized incidence ratios (sirs) and % confidence intervals were computed by comparing observed cancer rates to those expected in the general population. additionally, in order to control for known risk factors, a casecontrol study nested within the cohort was carried out as well based on telephone interviews with breast cancer cases and controls matched by : ratio. results: compared to . expected breast cancer cases, were observed (sir = . ;non-significant). risk for breast cancer was higher for women treated with clomiphene citrate (sir = . ; % ci . - . ). similar results were noted when treated and untreated women were compared, and when multivariate models were applied. in the nested case-control study, higher cycle index and treatment with clomiphene citrate were associated with significantly higher risk for breast cancer. conclusions: clomiphene citrate may be associated with higher breast cancer risk. smoking is a strong risk factor for arterial disease. some consider smoking also as a risk factor for venous thrombosis, while the results of studies investigating the relationship are inconsistent. therefore, we evaluated smoking as a risk factor for venous thrombosis in the multiple environmental and genetic assessment of risk factors for venous thrombosis (mega) study, a large population-based case-control study. consecutive patients with a first venous thrombosis were included from six anticoagulation clinics. using a random-digit-dialing method a control group was recruited in the same geographical area. all participants completed a questionnaire including questions on smoking habits. persons with known malignancies were excluded from the analyses, leading to a total of patients and controls. current and former smoking resulted in a small increased risk of venous thrombosis (ors adjusted for age, sex and bmi) (or-current: . ci : . - . , or-former: . ci : . - . ). an increasing amount and duration of smoking was associated with an increase in risk. the highest risk was found among young (lowest tertile: to yrs) current smokers; twenty or more pack-years resulted in a . -fold increased risk (ci : . - . ). in conclusion, smoking results in a small increased risk of venous thrombosis, with the greatest relative effect among young heavy smokers. objective: to explore whether the observed association between silica exposure and lung cancer was confounded by exposure to other occupational carcinogens, we conducted a nested case-control-study among a cohort of male workers in chinese mines and potteries. methods: lung cancer cases and matched controls were selected. exposure to respirable silica as well as relevant occupational confounders were evaluated quantitatively based on historical industrial hygiene data. the relationship between silica exposure and lung cancer mortality was analyzed by conditional logistic regression analysis adjusted for exposure to arsenic, polycyclic aromatic hydrocarbons (pahs), radon, and smoking habit. results: in a crude analysis adjusted for smoking only, a significant trend of increasing risk of lung cancer with exposure to silica was found for tin, copper/iron miners, and pottery workers. however, after the relevant occupational confounders were adjusted, no association can be observed between silica exposure and lung cancer mortality (pro mg/m -year increase of silica exposure: or = . , % ci: . - . ). conclusion: our results suggest that, the observed excess risk of lung cancer among silica exposed chinese workers is more likely due to exposure to other occupational carcinogens such as arsenic and pahs rather than due to exposure to respirable silica. background: modelling studies have shown that lifestyle interventions for adults with a high risk of developing diabetes are costeffective. objective: to explore the cost-effectiveness of lifestyle interventions for adults with low or moderate risk of developing diabetes. design and methods: the short-term effects of both a community-based lifestyle program for the general population and a lifestyle intervention for obese adults on diabetes risk factors were estimated from international literature. intervention costs were based on dutch projects. the rivm chronic diseases model was used to estimate long-term health effects and disease costs. costeffectiveness was evaluated from a health care perspective with a time horizon of years. results: intervention costs needed to prevent one case of diabetes in years range from , to , euro for the community program and from , to , euro for the intervention for obese adults. cost-effectiveness was , to , euro per quality adjusted life-year for the community program and , to , for the lifestyle intervention. conclusion: a lifestyle intervention for obese adults produces larger individual health benefits then a community program but, on a population level, health gains are more expensively achieved. both lifestyle interventions are cost-effective. background: in barcelona, the proportion of foreign-born patients with tuberculosis (tb) raised from . % in to , % in . objective: to determine differences in infection by country of origin among contacts investigated by the tb programme in barcelona from - . design and methods: data were collected on cases and their contacts. generalized estimating equations were used to obtain the risk of infection (or and % ci) to account for potential correlation among contacts. results: contacts of foreign born cases were more infected than contacts of natives patients ( % vs %, p< . ) factors related to infection among contacts of foreign cases were inner city residency (or: . , % ci: . - . ) and sputum smear positivity of the case (or: . , % ci: . - . ) and male contact (or: . , % ci: . - . ), but not daily contact (or: . , % ci: . - . ) among natives cases, inner city residency (or: . , % ci: . - . ), sputum smear positivity (or: . , % ci: . - . ) and daily exposure (or: . , % ci: . - . ) increased risk of infection. conclusion: contacts immigrant tb cases have a higher risk of infection than contacts of natives cases, however daily exposure to an immigrant case was not associated with a greater risk of infection. this could be explained by the higher prevalence of tb infection in their country of origin. background: an inverse association between birthweight and subsequent coronary heart disease (chd) has been widely reported but has not been formally quantified. we therefore conducted a systematic review of the association between birthweight and chd. design and methods: seventeen studies including a total of , singletons that had reported quantitative or qualitative estimates of the association between birthweight and chd by october were identified. additional data from two unpublished studies of individuals were also included. in total, the analyses included data on non-fatal and fatal coronary heart disease events in , individuals. results: the mean weighted estimate for the association between birthweight and chd incidence was . ( % ci . - . ) per kg of birthweight. overall, there was no significant heterogeneity between studies (p = . ) or evidence of publication bias (begg test p = . ). fifteen studies were able to adjust for some measure of socioeconomic position, but such adjustment did not materially influence the association: . ( % ci . - . ). discussion: these findings are consistent with one kilogram higher birthweight being associated with - % lower risk of subsequent chd, but the causal nature of this association remains uncertain and its direct relevance to public health is likely to be small. objective: diabetes has been reported to be associated with a greater coronary hazard among women compared with men with diabetes. we quantified the coronary risk associated with diabetes by sex by conducting a meta-analysis of prospective cohort studies. methods: studies reporting estimates of the relative risk for fatal coronary heart disease (chd) comparing those with and without diabetes, for both men and women were included. results: studies of type- diabetes and chd among , individuals were identified. the summary relative risk for fatal chd, diabetes versus not, was significantly greater among women than men: . ( % ci . to . ) versus . ( % ci . to . ), p< . . after excluding eight studies that had only adjusted for age, the sex risk difference was substantially reduced, but still highly significant (p = . ). the pooled ratio of the relative risks (female: male) from the multiple-adjusted studies was . ( % ci . to . ). conclusions: the relative risk for fatal chd associated with diabetes is % higher in women than in men. more adverse cardiovascular risk profiles among women with diabetes, combined with possible treatment disparities that favour men, may explain the greater excess coronary risk associated with diabetes in women. background: malaria in sri lanka is strongly seasonal and often of epidemic nature. the incidence has lowered in recent years which increased the relevance of epidemic forecasting for better targeting control resources. objectives: to establish the spatio/temporal correlation of precipitation and malaria incidence for use in forecasting. design and methods: de-trended long term ( de-trended long term ( - monthly time series of malaria incidence at district level were regressed in a poisson regression against rainfall and temperature at several lags. results: in the north and east of sri lanka, malaria seasonality is strongly positively correlated to rainfall seasonality (malaria lagging one or two months behind rainfall). however, in the south west, no significant (negative) correlation was found. also in the hill country, no significant correlation was observed. conclusion and discussion: despite high correlations, it still remains to be explored to what extent rainfall can be a used as a predictor (in time) of malaria. observed correlation could simply be due to two cyclical seasonal patterns running in parallel, without causal relationship. e.g. similarly, strong correlations were found between temperature and malaria seasonality at months time lag in northern districts, but causality is biologically implausible. background: few studies assessed the excess burden of acute respiratory tract infections (rti) among preschool children in primary care during viral seasons. objective: to determine the excess of rti in preschool children in primary care attributable to influenza and respiratory syncytial virus (rsv). methods: we performed a retrospective cohort study including all children aged - years registered in the database of the utrecht general practitioner (gp) network. during during - , gps recorded episodes of acute rti. surveillance data of influenza and rsv were obtained from the weekly sentinel system of the dutch working group on clinical virology. viral seasons and base-line period were defined as the weeks with respectively more than % and less than % of the yearly number of isolates of influenza or rsv. results: on average episodes of rti were recorded per , child years ( % ci: - ). notably more consults for rti occurred during influenza-season (rr . , % ci: . - . ) and rsv-season (rr . , % ci: . - . ) as compared to base-line period, especially in children younger than two years of age. conclusion: substantial excess rates of rti were demonstrated among preschool children in primary care during influenza-season and particularly during rsvseason, notably in the younger age group. background: many cancer patients who have already survived some time want to know about their prognosis, given the precondition that they are still alive. objective: we described and interpreted population-based conditional -year relative survival rates for cancer patients. methods: the longstanding eindhoven cancer registry collects data on all patients with newly diagnosed cancer in the southeastern part of the netherlands ( . million inhabitants). patients aged - years, diagnosed between and and followed up until january , were included. conditional -year relative survival was computed for every additional year survived. results: for many tumours conditional -year relative survival approached - % after having survived - years. however, for stomach cancer and hodgkin's lymphoma conditional -year relative survival increased to only - % and for lung cancer and non-hodgkin's lymphoma it did not exceed - %. initial differences in survival at diagnosis between age and stage groups disappeared after having survived for - years. conclusion: prognosis for patients with cancer changes with each year survived and for most tumours patients can considered to be cured after a certain period of time. however, for stomach cancer, lymphoma's and lung cancer the odds for death remains elevated compared to the general population. background: systematic review with meta-analysis, now regarded as 'best evidence', depends on availability of primary trials and on completeness of review. whilst reviewers have attempted to assess publication bias, relatively little attention has been given to selection bias by reviewers. method: systematic reviews of three cardiology treatments, that used common search terms, were compared for inclusion/exclusion of primary trials, pooled measures of principal outcomes and conclusions. results: in one treatment, reviews included , , , , and trials. there was little overlap: of trials in the last review only , , , and were included by others. reported summary effects ranged from (most effective to least significant); mortality relative risk . ( . , . ) in trials to . ( . , . ) in , and in one morbidity measure; standardised mean difference from . ( . , . ) in trials ( patients) to . () . , . ) in ( patients). reviewers' conclusions ranged from 'highly effective' to 'no evidence of effect'. conclusions: these examples illustrate strong selection bias in published meta-analyses. post hoc review contravenes one important principal of science 'first the hypothesis, then the test'. selection bias by reviewers may affect 'evidence' more than does publication bias. in the context of a large population based german case control study examining the effects of hormone therapy (ht) on breast cancer risk, we conducted a validation study comparing ht prescription data with participants' self-reports for data quality assurance. included were cases and controls aged - years, stratified by age and hormone use. study participants provided detailed information on ht use to trained interviewers, while gynecologists provided prescription data via telephone or fax. data were compared using proportion of agreement, kappa, intraclass correlation coefficient (icc), and descriptive statistics. overall agreement for ever/never use was . %, while agreement for ever/never use by type of ht was . %, . %, and . % for mono-estrogen, cyclical, and continuous combined therapy, respectively. icc for duration was high ( . ( % ci: . - . )), as were the iccs for age at first and last use ( . ( % ci: . - . ) and . ( % ci: . - . ), respectively). comparison of exact brand name resulted in perfect agreement for . % of participants, partial agreement for . %, and no agreement for . %. higher education and shorter length of recall were associated with better agreement. agreement was not differential by disease status. in conclusion, these self-reported ht data corresponded well with gynecologists' reports. background: legionnaires' disease (ld) is a pneumonia of low incidence. however, the impact of an outbreak can be substantial. objective: to stop a possible outbreak at an early stage, an outbreak detection programme was installed in the netherlands and evaluated after two years. design: the programme was installed nationally and consisted of sampling and controlling of potential sources to which ld patients had been exposed during their incubation period. potential sources were considered to be true sources of infection if two or more ld patients (cluster) had visited them, or if available patients' and environmental strains were indistinguishable by amplified fragment length polymorphism genotyping. all municipal health services of the netherlands participated in the study. the regional public health laboratory kennemerland sampled potential sources and cultured samples for legionella spp. results: rapid sampling and genotyping as well as cluster recognition helped to target control measures. despite these measures, two small outbreaks were only stopped after renewal of the water system. the combination of genotyping and cluster recognition lead to of ( %) patient-source associations. conclusion and discussion: systematic sampling and cluster recognition can contribute to ld outbreak detection and control. this programme can cost-effectively lead to secondary prevention. -up ( - ) , primary invasive breast cancers occurred. results: compared with hrt never-use, use of estrogen alone was associated with a significant . -fold increased risk. the association of estrogen-progestagen combinations with breast cancer risk varied significantly according to the type of progestagen: while there was no increase in risk with estrogen-progesterone (rr . [ . - . ]), estrogen-dydrogesterone was associated with a significant . -fold increase, and estrogen combined with other synthetic progestins with a significant . -fold increase. although the latter type of hrt involves a variety of different progestins, their associations with breast cancer risk did not differ significantly from one another. rrs did not vary significantly according to the route of estrogen administration (oral or transdermal/percutaneous). conclusion and discussion: progesterone rather than synthetic progestins may be preferred when an opposed estrogen therapy is to be prescribed. additional results on estrogen-progesterone are needed. background: although survival of hodgkin's lymphoma (hl) is high (> %), treatment may cause long-term side-effects like premature menopause. objectives: to assess therapy-related risk factors for premature menopause (age < ) following hl. design and methods: we conducted a cohort-study among female year hl-survivors, aged < at diagnose and treated between and . patients were followed from first treatment until june , menopause, death, or age . cumulative dose of various chemotherapeutic agents as well as radiation fields were studied as risk factors for premature menopause. cox-regression was used to adjust for age, year of treatment, smoking, bmi, and oral contraceptive-use. results: after a median follow-up of . years, ( %) women reached premature menopause. overall women ( %) were treated with chemotherapy only, ( %) with radiotherapy only and ( %) with both radio-and chemotherapy. exposure to procarbazine ), cyclophosphamide (hr . [ . - . ] ) and irradiation of the ovaries ]) were associated with significant increased risks for premature menopause. for procarbazine a dose-response relation was observed. procarbazine-use has decreased over time. conclusion: to decrease the risk for premature menopause after hl, procarbazine and cyclophosphamide exposure should be minimized and ovarian irradiation should be avoided. background: casale is an italian town where a large asbestos cement plant was active for decades. previous studies found increased risk for mesothelioma in residents, suggesting a decreasing spatial trend with distance from the plant. objective: to analyse the spatial variation of risk in casale and the surrounding area ($ , inhabitants) focussing on non-occupationally exposed individuals. design/methods: population-based case-control study including pleural mesotheliomas diagnosed between and . information on the cases and controls comprised lifelong residential and occupational history of subjects and their relatives. nonparametric tests of clustering were used to evaluate spatial aggregation. parametric spatial models based on distance between the longest-lasting subject residence (excluding the last years before diagnosis) and the source enabled estimation of risk gradient. results: mesothelioma risk appeared higher in an area of roughly - km radius from the source. spatial clustering was statistically significant (p = . ) and several clusters of cases were identified within casale. risk was highly related to the distance from the source; the best fitting model was the exponential decay with threshold. conclusion/discussion: asbestos pollution has increased dramatically the risk of mesothelioma in the area around casale. risk decreases slowly with the square of distance from the plant. malaria control programmes targeting malaria transmission from man to mosquito can have a large impact of malaria morbidity and mortality. to successfully interrupt transmission, a thorough understanding of disease and transmission parameters is essential. our objective was to map malaria transmission and analyse microenvironmental factors influencing this transmission in order to select high risk areas where transmission reducing interventions can be introduced. each house in the village msitu-wa-tembo was mapped and censused. transmission intensity was estimated from weekly mosquito catches. malaria cases identified through passive case detection were mapped by residence using gis software and the incidence of cases by season and distance to river were calculated. the distribution of malaria cases showed a clear seasonal pattern with the majority of cases during the rainy season (chisquare = . , p< . ). living further away from the river (p = . ) was the most notable independent protective factor for malaria infection. transmission intensity was estimated at . ( % ci . - . ) infectious bites per person per year. we show that malaria in the study area is restricted to a short transmission season. spatial clustering of cases indicates that interventions should be planned in the area closest to the river, prior and during the rainy season. background: the effectiveness of influenza vaccination of elders has been subject of some dispute. its impact on health inequalities also demands epidemiological assessments, as health interventions may affect early and most intensely better-off social strata. objectives: to compare pneumonia and influenza (p&i) mortality of elders (aged or more years old) before and after the onset of a largescale scheme of vaccination in sao paulo, brazil. methods: official information on deaths and population allowed the study of p&i mortality at the inner-city area level. rates related to the period to , during which vaccination coverage ranked higher than % of elders were compared with figures related to the precedent period ( ) ( ) ( ) ( ) ( ) . the appraisal of mortality decrease used a geo-referred model for regression analysis. results: overall p&i mortality reduced . % after vaccination. also the number of outbreaks, the excess of deaths during epidemic weeks, and the proportional p&i mortality ratio reduced significantly after vaccination. besides having higher prior levels of p&i deaths, deprived areas of the city presented a higher proportional decrease of mortality. conclusion: influenza vaccination contributed for an overall reduction of p&i mortality, while reducing the gap in the experience of disease among social strata. background: alcohol's first metabolite, acetaldehyde, may trigger aberrations in dna which predispose to developing colorectal cancer (crc) through several distinct pathways. our objective was to study associations between alcohol consumption and the risk of crc, according to two pathways characterized by mutations in apc and k-ras genes, and absence of hmlh expression. methods: in the netherlands cohort study, , men and women, aged - years, completed a questionnaire on risk factors for cancer in . case-cohort analyses were conducted using crc cases with complete data after . years of follow-up, excluding the first . years. gender-specific adjusted incidence rate ratios (rr) and % confidence intervals (ci) were estimated. results: neither total alcohol, nor beer, wine or liquor consumption was clearly associated with the risk of colorectal tumors lacking hmlh expression or harboring a truncating apc mutation and/or an activating k-ras mutation. in men and women, total alcohol consumption above g/day was associated with an increased risk of crc harboring a truncating apc and/or activating k-ras mutation, though not statistically significant. (rr: . ( % ci: . - . ) in men, rr: . ( % ci: . - . ) in women). in conclusion, alcohol consumption is not involved in the studied pathways leading to crc. background: educational level is commonly used to identify social groups with increased prevalence of smoking. other indicators of socioeconomic status (ses) might however be more discriminatory. objective: this study examines to what extent smoking behaviour is related to other ses indicators, such as labour market position and financial situation. methods: data derived from the european household panel, which includes data on smoking for european countries. we selected data for , respondents aged - years. the association between ses indicators and smoking prevalence was examined through logistic regression analyses. results: preliminary results show that, in univariate analysis, all selected ses indicators were associated with smoking. higher rates of smoking in lower social groups were observed in all countries, except for women in some mediterranean countries. in multivariate analyses, education retained an independent effect on smoking. no strong effect was observed for labour market position (occupational class, employment status) or for income. however, smoking prevalence was strongly related to economic deprivation and housing tenure. conclusion: these results suggest that different aspects of people's ses affect their smoking behaviour. interventions that aim to tackle smoking among high-risk groups should identify risk groups in terms of both education and material deprivation. objective: we investigated time trends in overweight and leisure time physical activities (ltpa) in the netherlands since . intra-national differences were examined stratified for sex, age and urbanisation degree. design and methods: we used a random sample from the health interview survey of about respondents, aged -to- years. self-reported data on weight, height and demographic characteristics were gathered through interviews (yearly) and data on ltpa were collected by selfadministered questionnaires . linear regression was performed for trend analyses. results: during - , mean body mass index (bmi) increased by . kg/m (p = . ). trends were similar across sex and urbanisation degrees. in -to- year old women, mean bmi increased more ( . kg/m ; p = . ) than in older women. concerning ltpa, no clear trend was observed during observed during - and observed during - . however, in year old women spent $ min/wk less on ltpa compared to older women, while this difference was smaller during - . conclusions: mean bmi increased more in younger women, which is consistent with the observation that this group spent less time on ltpa during recent years. although the overall increase in overweight could no´t be explained by trends in ltpa, physical activity interventions should target the younger women. background: prediction rules combine patient characteristics and test results to predict the presence of an outcome (diagnosis) or the occurrence of an outcome (prognosis) for individual patients. when prediction rules show poor performance in new patients, investigators often develop a new rule, ignoring the prior information available in the original rule. recently, several updating methods have been proposed that consider both prior information and information of the new patients. objectives: to compare five updating methods (that vary in extensiveness) for an existing prediction rule that preoperatively predicts the risk of severe postoperative pain (spp). design and methods: the rule was tested and updated on a validation set of new surgical patients ( ( %) with spp). we estimated the discrimination (the ability to discriminate between patients with and without spp) and calibration (the agreement between the predicted risks and observed frequencies of spp) of the five updated rules in other patients ( ( %) with spp). results: simple updating methods showed similar effects on calibration and discrimination as the more complex methods. discussion and conclusion: when the performance of a prediction rule in new patients is poor, a simple updating method can be applied to improve the predictive accuracy. about two million ethnic germans (aussiedler) have resettled in germany since . analyses with a yet incomplete follow-up of a cohort of aussiedler showed a different mortality compared to russia and germany. objectives: we investigated whether the mortality pattern changed after a complete follow-up and whether residential mobility after resettlement has an effect on mortality. we established a cohort of aussiedler who moved to germany between and . we calculated smr for all causes, external causes, cardiovascular deaths and cancer in comparison to german rates. results: with a complete follow-up, the cohort accumulated person years. overall, deaths were observed (smr . , % ci: . - . ). smr for all external causes, all cancer and cardiovascular deaths were . , . and . , respectively. increased number of moves within germany was associated with increased mortality. conclusion and discussion: the mortality in the cohort is surprisingly low, in particular for cardiovascular deaths. there is a mortality disadvantage from external causes and for some selected cancers. this disadvantage is however not as large as would be expected if aussiedler were representative of the general population in fsu countries. mobility as an indicator for a lesser integration will be discussed. background: breast cancer screening (bcs) provides an opportunity to analyze the relationship between lymph node involvement (ln), the most important prognostic factor, and biological and time dependent characteristics. objective: our aim was to assess those characteristics that are associated with ln in a cohort of screen-detected breast cancers. methods: observational population study of all invasive cancers within stage i-iiia detected from to through a bcs program in catalonia (spain). age, tumor size, histological grade, ln status and screening episode (prevalent or incident) were analyzed. pearson chi-square or fisher's exact test, mann-whitney test and stratified analyses were applied, as well as multiple logistic regression techniques. results: twenty nine percent ( % ci . - . %) out of invasive cancers had ln and . % were prevalent cancers. in the bivariate analysis, tumor size and age were strongly associated to ln (p< . ) while grade was related to ln only in incident cancers (p = . ). grade was associated with tumor size (p = . ) and with screening episode (p = . ). adjusting for screening episode and grade, age and tumor size were independent predictors of ln. conclusion: in conclusion, age and tumor size are independent predictors of ln. grade emerges as an important biological factor in incident cancers. background: the evidence regarding the association between smoking and cognitive function in the elderly is inconsistent. objectives: to examine the association between smoking and cognitive function in the elderly. design and methods: in , all participants of a population-based cohort study aged years or older were eligible for a telephone interview on cognitive function using validated instruments, such as the telephone interview of cognitive status (tics). information on smoking history was available from questionnaires administered in . we estimated the odds ratios (or) of cognitive impairment (below th percentile) and the corresponding % confidence intervals (ci) by means of logistic regression adjusting for age, sex, alcohol consumption, body mass index, physical exercise, educational level, depressive symptoms and co-morbidity. results: in total, participants were interviewed and had complete information on smoking history. former smokers had a lower prevalence of cognitive impairment (oradjusted = . ; % ci: . - . ) compared with never smokers, but not current smokers (oradjusted = . ; % ci: . - . ). conclusion: there is no association between current smoking and cognitive impairment in the elderly. discussion: the lack of association between current smoking and cognitive impairment is in line with previous non-prospective studies. the inverse association with former smoking might be due to smoking cessation associated with co-morbidities. background: many studies have reported late effects of treatment in childhood cancer survivors. most studies, however, focused on only one late effect or suffered from incomplete follow-up. objectives: we assessed the total burden of adverse events (ae), and determined treatment-related risk factors for the development of various aes. methods: the study cohort included -year survivors, treated in the emma childrens hospital amc in the netherlands between - . aes were graded for severity by one reviewer according to the common terminology criteria adverse events version . . results: medical follow-up data were complete for . % -year survivors. median follow-up time was years. almost % of survivors had one or more aes, and . % had even or more aes. of patients treated with rt alone, % had a high or severe burden of aes, while this was only % in patients treated with ct alone. radiotherapy (rt) was associated with the highest risk to develop an ae of at least grade , and was also associated with a greater risk to develop a medium to severe ae burden. conclusions: survivors are at increased risk for many health problems that may adversely affect their quality of life and long-term survival. background: studies in the past demonstrated that multifaceted interventions could enhance the quality of diabetes care. however many of these studies showed methodological flaws as no corrections were made for patient case-mix and clustering or a nonrandomised design was used. objective: to assess the efficacy of a multifaceted intervention to implement diabetes shared care guidelines. methods: a cluster randomised controlled trial of patients with type diabetes was conducted at general practises (n = ) and one outpatient clinic (n = ). in primary care, facilitators analysed barriers to change, introduced structured care, gave feedback and trained practice staff. at the outpatient clinic, an abstract of the guidelines was distributed. case-mix differences such as duration of diabetes, education, co-morbidity and quality of life were taken into account. results: in primary care, more patients in the intervention group were seen on a three monthly basis ( . % versus . %, p< . ) and their hba c was statistically significant lower ( . ± . versus . ± . , p< . ). however, significance was lost after correction for case-mix (p = . ). change in blood pressure and total cholesterol was not significant. we were unable to demonstrate any change in secondary care. conclusion: multifaceted implementation did improve the process of care but left cardiovascular risk unchanged. background: we have performed a meta-analysis including studies on the diagnostic accuracy of mr-mammography in patients referred for further characterization of suspicious breast lesions. using the bivariate diagnostic meta-analysis approach we found an overall sensitivity and specificity of . and . , respectively. the aim of the present analysis was to detect heterogeneity between studies. materials and methods: seventeen study and population characteristics were separately included in the bivariate model to compare sensitivity and specificity between strata of the characteristics. results: both sensitivity and specificity were higher in studies performed in the united states compared to non-united states studies. both estimates were also higher if two criteria for malignancy were used instead of one or three. only specificity was affected by the prevalence of cancer: specificity was highest in studies with the lowest prevalence of cancer in the study population. furthermore, specificity was affected by whether the radiologist was blinded for clinical information: specificity was higher if there was no blinding. conclusions: variation between studies was notably present across studies in country of publication, the number of criteria for malignancy, the prevalence of cancer and whether the observers were blinded for clinical information. objective: the aim of this project is to explore variation in three candidate genes involved in cholesterol metabolism in relation to risk of acute coronary syndrome (acs), and to investigate whether dietary fat intake modifies inherent genetic risks. study population: a case-cohort study is designed within the danish 'diet, cancer and health' study population. a total of cases of acs have been identified among , men and women who participated in a baseline examination between - when they were aged - years. a random sample of participants will serve as 'control' population. exposures: all participants have filled out a detailed -item food frequency questionnaire and a questionnaire concerning lifestyle factors. participants were asked to provide a blood sample. candidate genes for acs have been selected among those involved in cholesterol transport (atp-binding cassette transporter a , cholesterol-ester transfer protein, and acyl-coa:cholesterol acyltransferase ). five single nucleotide polymorphisms (snps) will be genotyped within each gene. snps will be selected among those with demonstrated functional importance, as assessed in public databases. methods: statistical analyses of association between genetic variation in the three chosen genes and risk of acs. explorations of methods to evaluate biological interaction will be of particular focus. background: c-reactive protein (crp) has been shown to be associated with type diabetes mellitus. it is unclear whether the association is completely explained by obesity. objective: to examine whether crp is associated with diabetes independent of obesity. design and methods: we measured baseline characteristics and serum crp in non-diabetic participants of the rotterdam study and followed them for a mean of . years. cox regression was used to estimate the hazard ratio. in addition, we performed a meta-analysis on published studies. results: during follow-up, participants developed diabetes. serum crp was significantly and positively associated with the risk to develop diabetes. the risk estimates attenuated but remained statistically significant after adjustment for obesity indexes. age, sex and body mass index (bmi) adjusted hazard ratios ( % ci) were . ( . - . ) for the fourth quartile, . ( . - . ) for the third quartile, and . ( . - . ) for the second quartile of serum crp compared to the first quartile. in the meta-analysis, weighed age, sex, and bmi adjusted risk ratio was . ( . - . ), for the highest crp category (> . mg/l) compared to the reference category (< . mg/l). conclusion: our findings shows that the association of serum crp with diabetes is independent of obesity. background: effectiveness of screening can be predicted by episode sensitivity, which is estimated by interval cancers following a screen. full-field digital or cr plate mammography are increasingly introduced into mammography screening. objectives: to develop a design to compare performance and validity between screen-film and digital mammography in a breast cancer screening program. methods: interval cancer incidence was estimated by linking screening visits from - at an individual level to the files of the cancer registry in finland. these data was used to estimate the study size requirements for analyzing differences in episode sensitivity between screen-film and digital mammography in a randomized setting. results: the two-year cumulative incidence of interval cancers per screening visits was estimated to be . to allow the maximum acceptable difference in the episode sensitivity between screenfilm and digital arm to be % ( % power, . significance level, : randomization ratio, % attendance rate), approximately women need to be invited. conclusion: only fairly large differences in the episode sensitivity can be explored within a single randomized study. in order to reduce the degree of non-inferiority between the screen-film and digital mammography, meta-analyses or pooled analyses with other randomized data are needed. session: socio-economic status and migrants presentation: oral. background: tackling urban/rural inequalities in health has been identified as a substantial challenge in reforming health system in lithuania. objectives: to assess mortality trends from major causes of death of the lithuanian urban and rural populations throughout the period of - . methods: information on major causes of death (cardiovascular diseases, cancers, external causes, and respiratory diseases) of lithuanian urban and rural populations from to was obtained from lithuanian department of statistics. mortality rates were age-standardized, using european standard. mortality trends were explored using the logarithmic regression analysis. results: overall mortality of lithuanian urban and rural populations was decreasing statistically significantly during - . more considerable decrease was observed in urban areas where mortality declined by . % per year in males and . % in females, compare to the decline by . % in males and . % in females in rural areas. the most notable urban/rural differences in mortality trends with unfavourable situation in rural areas were estimated in mortality from stoke, breast cancer in females, and external causes of death (traffic accidents and suicides). background: recent studies indicate that depression plays an important role in the occurrence of cardiovascular diseases (cvd). underlying mechanisms are not well understood. objectives: we investigated whether low intake of omega- fatty acids (fas) is a common cause for depression and cvd. methods: the zutphen elderly study is a prospective cohort study conducted in the netherlands. depressive symptoms were measured with the zung scale in men, aged - years, and free from cvd and diabetes in . dietary factors were assessed with a cross-check dietary history method. results: compared to high intake (= . mg/d), low intake (< . mg/d) of omega- fas, adjusted for demographics and cvd risk factors, was associated with an increased risk of depressive symptoms (or . ; % ci . - . ) at baseline, and non-significantly with -year cvd mortality (hr . ; % ci . - . ). the adjusted hr for a -point increase in depressive symptoms for cvd mortality was . ( % ci . - . ), and did not change after additional adjustment for omega- fas. conclusion: low intake of omega- fas may increase the risk of depression. our results, however, do not support the hypothesis that low intake of omega- fas explains the relation between depression and increased risk of cvd. background: during the last decades the incidence of metabolic syndrome has risen dramatically. several studies have shown beneficial effects of nut and seed intake on components of this syndrome. the relationship with prevalence of metabolic syndrome has not yet been examined. objectives: we studied the relation between nut and seed intake and metabolic syndrome in coronary patients. design and methods: presence of metabolic syndrome (according to international diabetes federation definition) was assessed in stable myocardial infarction patients ( % men) aged - years, as part of the alpha omega trial. dietary data were collected by food-frequency questionnaire. results: the prevalence of metabolic syndrome was %. median nut and seed intake was . g/day (interquartile range, . - . g/day). intake of nuts and seeds was inversely associated with the metabolic syndrome (prevalence ratio: . ; % confidence interval: . - . , for > g/day versus < g/day), after adjustment for age, gender, dietary and lifestyle factors. the prevalence of metabolic syndrome was % lower (p = . ) in men with a high nut and seed intake compared to men with a low intake, after adjustment for confounders. conclusion and discussion: intake of nuts and seeds may reduce the risk of metabolic syndrome in stable coronary patients. background: in epidemiology, interaction is often assessed by adding a product term to the regression model. in linear regression the regression coefficient of the product term refers to additive interaction. however, in logistic regression it refers to multiplicative interaction. rothman has argued that interaction as departure from additivity better reflects biological interaction. hosmer and lemeshow presented a method to quantify additive interaction and its confidence interval (ci) between two dichotomous determinants using logistic regression. objective: our objective was to provide an estimation method for additive interaction between continuous determinants. methods and results: from the abovementioned literature we derived the formulas to quantify additive interaction and its ci between one continuous and one dichotomous determinant and between two continuous determinants using logistic regression. to illustrate the theory, data of the utrecht health project were used, with age and body mass index as risk factors for diastolic blood pressure. conclusions: this paper will help epidemiologists to estimate interaction as departure from additivity. to facilitate its use, we developed a spreadsheet, which will become freely available at our website. background: the incidences of acute myocardial infarction (ami) and ischemic stroke (is) in finland have been among highest in the world. accurate geo-referenced epidemiological data in finland provides unique possibilities for ecological studies using bayesian spatial models. objectives: examine sex-specific geographical patterns and temporal variation of ami and is. design and methods: ami (n = , ) and is (n = , ) cases in - in finland, localized at the time of diagnosis according to the place of residence address using map coordinates. cases and population were aggregated to km x km grids. full bayesian conditional autoregressive models (car) were used for studying the geographic incidence patterns. results: the incidence patterns of ami and is showed on average % ( % ci - %) common geographic variation and significantly the rest of the variation was disease specific. there was no significant difference between sexes. the patterns of high-risk areas have persisted over the years and the pattern of is showed more annual random fluctuations. conclusions: although ami and is showed rather similar and temporally stable patterns, significant part of the spatial variation was disease specific. further studies are needed for finding the reasons for disease specific geographical variation. most studies addressing socio-economic inequalities in health services use fail to take into account the disease the patient is suffering from. the objective of this study is to compare possible socioeconomic differences in the use of ambulatory care between distinct patient groups: diabetics and patients with migraine. data was obtained from the belgian health interview surveys , and . in total patients with self reported diabetes or migraine were identified. in a multilevel analysis the probability of a contact and the volume of contacts with the general practitioner and/or the specialist were studied for both groups in relation to educational attainment and income. adjustment was made for age, sex, subjective health and comorbidity at the individual level, and doctors' density and region at district level. no socio-economic differences were observed among diabetic patients. among patients with migraine we observed a higher probability of specialist contacts in higher income groups (or , ; % ci , - , ) and higher educated persons (or , ; % ci , - , ), while lower educated persons tend to report more visits with the general practitioner. to correctly interpret socio-economic differences in the use of health services there is need to take into account information on the patient's type of disease. background: the suitability of non-randomised studies to assess effects of interventions has been debated for a long time, mainly because of the risk of confounding by indication. choices in the design and analytical phase of non-randomised studies determine the ability to control for such confounding, but have not been systematically compared yet. objective: the aim of the study will be to quantify the role of design and analytical factors on confounding in non-randomised studies. design and methods: a meta-regression analysis will be conducted, based on cohort and case-control studies analysed in a recent cochrane review on influenza vaccine effectiveness against hospitalisation or death in the elderly. primary outcome will be the degree of confounding as measured by the difference between the reported effect estimate (odds ratios or relative risks) and the best available estimate (nichol, unpublished data) . design factors that will be considered include study design, matching, restriction and availability of confounders. statistical techniques that will be evaluated include multivariate regression analysis with adjustment for confounders, stratification and, if available, propensity scores. results the rsults will be used to develop a generic guideline with recommendations how to prevent confounding by indication in non-randomised effect studies. the wreckage of the oil tanker prestige in november produced a heavy contamination of the coast of galicia (spain). we studied relationships between participation in clean-up work and respiratory symptoms in local fishermen. questionnaires including details of clean-up activities and respiratory symptoms were distributed among associates of fishermen's cooperatives, with postal and telephone follow-up. statistical associations were evaluated using multiple logistic regression analyses, adjusted for sex, age, and smoking status. between january and february , information was obtained from , fishermen (response rate %). sixty-three percent had participated in clean-up operations. lower respiratory tract symptoms were more prevalent in clean-up workers (odds ratio (or) . ; % confidence interval . - . ). the risk increased when the number of exposed days, number of hours per day, or number of activities increased (p for linear trend < . ). the excess risk decreased when more time had elapsed since last exposure (or . ( . - . ) and . ( . - . ) for more and less than months, respectively; p for interaction < . ). in conclusion, fishermen who participated in the clean-up work of the prestige oil spill show a prolonged dosedependent increased prevalence of respiratory symptoms one to two years after the beginning of the spill. background. hpv testing has been proposed for cervical cancer screening. objectives: evaluating the protection provided by hpv testing at long intervals vs. cytology every third year. methods: randomised controlled trial conventional arm: conventional cytology. experimental arm: in phase hpv and liquid-based cytology. hpv-positive cytology-negatives referred for colposcopy if age - , for repeat after one year if age - . in phase hpv alone. positives referred for colposcopy independently of age. endpoint: histologically confirmed cervical intraepithelial neoplasia (cin) grade or more. results: overall , women were randomised. preliminary data at recruitment are presented. overall, among women aged - years relative sensitivity of hpv versus conventional cytology was . ( % c.i. . - . ) and relative positive predictive (ppv) value was . ( % c.i. . - . ). among women aged - relative sensitivity of hpv vs. conventional cytology was . ( % c.i. . - . ) during phase but . ( % c.i. . - . ) during phase . conclusions: hpv testing increased cross-sectional sensitivity, but reduced ppv. in younger women data suggest that direct referral of hpv-positives to colposcopy results in relevant overdiagnosis of regressive lesions. measuring detection rate of cin at the following screening round will allow studying overdiagnosis and the possibility of longer screening intervals. background: plant lignans are present in foods such as whole grains, seeds, fruits and vegetables, and beverages. they are converted by intestinal bacteria into the enterolignans, enterodiol and enterolactone. enterolignans possess several biological activities whereby they may influence carcinogenesis. objective: to study the association between plasma enterolignans and the risk of colorectal adenomas. colorectal adenomas are considered to be precursors of colorectal cancer. design and method: the case-control study included cases with at least one histologically confirmed colorectal adenoma and controls with no history of any type of adenoma. associations between plasma enterolignans and colorectal adenomas were analyzed by logistic regression. results: associations were stronger for incident than for prevalent cases. when only incident cases (n = ) were included, high compared to low enterodiol plasma concentrations were associated with a reduction in colorectal adenoma risk after adjustment for confounding variables. enterodiol odds ratios ( % ci) were . , . ( . - . ), . ( . - . ), . ( . - . ) with a significant trend (p = . ) through the quartiles. although enterolactone plasma concentrations were fold higher, enterolactone's reduction in risk was not statistically significant (p for trend = . ). conclusion: we observed a substantial reduction in colorectal adenoma risk among subjects with high plasma concentrations of enterolignans, in particular enterodiol. background: smoking is a risk factor for tuberculosis diseases. recently the question was raised if smoking also increases the risk of tuberculosis infection. objective: to assess the influence of environmental tobacco smoke (ets) exposure in the household on tuberculosis infection in children. design and methods: a crosssectional community survey was done and information on children was obtained. tuberculosis infection was determined with a tuberculin skin test (tst) (cut-off mm) and information on smoking habits was obtained from all adult household members. univariate and multivariate analyses were performed, and odds ratio (or) was adjusted for the presence of a tb contact in the household, crowding and age of the child. results: ets was a risk factor for tuberculosis infection (or: . , % ci: . - . ) when all children with a tst read between two and five days were included. the adjusted or was . ( % ci: . - . ). in dwellings were a tuberculosis case had lived the association was strongest (adjusted or . , % ci: . - . ). conclusion and discussion: ets exposure seems to be a risk factor for tuberculosis infection in children. this is of great concern considering the high prevalence of smoking and tuberculosis in developing countries. background and objective: to implement a simulation model to analyze demand and waiting time (wt) for knee arthroplasty and to compare a waiting list prioritization system (ps) with the usual first-in, first-out (fifo) system. methods: parameters for the conceptual model were estimated using administrative data and specific studies. a discrete-event simulation model was implemented to perform -year simulations. the benefit of applying the ps was calculated as the difference in wt weighted by priority score between disciplines, for all cases who entered the waiting list. results: wt for patients operated under the fifo discipline was homogeneous (standard deviation (sd) between . - . months) with mean . . wt under the ps had higher variability (sd between . - . ) and was positively skewed, with mean . months and % of cases over months. when wt was weighted by priority score, the ps saved . months ( % ci . - . ) on average. the ps was favorable for patients with priority scores over , but penalized those with lower priority scores. conclusions: management of the waiting list for knee arthroplasty through a ps was globally more effective than through fifo, although patients with low priority scores were penalized with higher waiting times. background: we developed a probabilistic linkage procedure for the linking of readmissions of newborns from the dutch paediatrician registry (lnr). % of all newborns ( . ) are admitted to a neonatal ward. the main problems were the unknown number of readmissions per child and the identification of admissions of twins. objective: to validate our linking procedure in a double blinded study. design and methods: a random sample of admissions from children from the linked file has been validated by the caregivers, using the original medical records. results: response was %. for admissions of singletons the linkage contained no errors except for the small uncertain area of the linkage. for admissions of multiple births a high error rate was found. conclusion and discussion: we successfully linked the admissions of singleton newborns with the developed probabilistic linking algorithm. for multiple births we did not succeed in constructing valid admission histories due to too low data quality of twin membership variables. validation showed alternative solutions for linking twin admissions. we strongly recommend that linkage results should always be externally validated. background: salmonella typhimurium definitive phage type (dt) has emerged as an important pathogen in the last two decades. a -fold increase in cases in the netherlands during september-november prompted an outbreak investigation. objective: the objective was to identify the source of infection to enable preventive measures. methods: a subset of outbreak isolates was typed by molecular means. in a case-control study, cases (n = ) and matched population controls (n = ) were invited to complete self-administered questionnaires. results: the molecular typing corroborated the clonality of the isolates. the molecular type was similar to that of a recent s. typhimurium dt outbreak in denmark associated with imported beef. the incriminated shipment was traced after having been distributed sequentially through several eu member states. sampling of the beef identified s. typhimurium dt of the same molecular type as the outbreak isolates. cases were more likely than controls to have eaten a particular raw beef product. conclusions: our preliminary results are consistent with this s. typhimurium dt outbreak being caused by contaminated beef. our findings underline the importance of european collaboration, traceability of consumer products and a need for timely intervention into distribution chains. background: heavy-metals may affect newborns. some of them are presenting tobacco smoke. objectives: to estimate cord-blood levels of mercury, arsenic, lead and cadmium in newborns in areas in madrid, and to assess the relationship with maternal tobacco exposure. design and methods: bio-madrid study obtained cord-blood samples from recruited trios (mother/father/ newborn). cold-vapor atomic absorption spectrophotometry (aas) was used to measure mercury and graphite-furnace aas for the other metals. mothers answered a questionnaire including tobacco exposure. median, means and standard errors were calculated and logistic regression used to estimate or. results: median levels for mercury and lead were . mg/l and . mg/l. arsenic and cadmium were undetectable in % and % of samples. preliminar analysis showed a significant association of maternal tobacco exposure and levels of arsenic (or: . ; % ci: . - . ), cadmium (or: . ; % ci: . - . ), and lead (or: . ; % ci: . - . ). smoking in pregnancy was associated to arsenic (or: . ; % ci: . - . ), while passive exposure was more related to lead (or: . ; % ci: . - . ) and cadmium (or: . ; % ci: . - . ). conclusion: madrid newborns have high cord-blood levels of mercury. tobacco exposure in pregnancy might increase levels of arsenic, cadmium and lead. background: road traffic accidents (rta) are the leading cause of death for young. rta police reports provide no health information other then the number of deaths and injured, while health databases have no information on the accident dynamics. the integration of the two databases would allows to better describe the phenomenon. nevertheless, the absence of common identification variables through the lists makes the deterministic record linkage (rl) impossible. objective: to test feasibility of a probabilistic rl between rta and health information when personal identifiers are lacking. methods: health information came from the rta integrated surveillance for the year . it integrates data from ed visits, hospital discharges and deaths certificates. a deterministic rl was performed with police reports, where the name and age of deceased were present. results of the deterministic rl was then used as gold standard to evaluate the performance of the probabilistic one. results: the deterministic rl resulted in ( . %) linked records. the probabilistic rl, where the name was omitted, was capable to correctly identify ( . %). conclusions: performance of the probabilistic rl was good. further work is needed to develop strategies for the use of this approach in the complete datasets. background: overweight constitutes a major public health problem. the prevalence of overweight is unequally distributed between socioeconomic groups. risk group identification, therefore, may enhance the efficiency of interventions. objectives: to identify which socioeconomic variable best predicts overweight in european populations: education, occupation or income. design: european community household panel data were obtained for countries (n = , ). overweight was defined as a body mass index >= kg/m . uni-and multivariate logistic regression analyses were employed to predict overweight in relationship to socioeconomic indicators. results: major socioeconomic differences in overweight were observed, especially for women. for both sexes, a low educational attainment was the strongest predictor of overweight. after control for confounders and the other socioeconomic predictors, the income gradient was either absent or positive (men) or negative (women) in most countries. similar patterns were found for occupational level. for women, inequalities in overweight were generally greater in southern european countries. conversely, for men, differences were generally greater in other european countries. conclusion: across europe, educational attainment most strongly predicts overweight. therefore, obesity interventions should target adults and children with lower levels of education. background: because incidence and prevalence of most chronic diseases rise with age, their burden will increase in ageing populations. we report the increase in prevalence of myocardial infarction (mi), stroke (cva), diabetes type ii (dm) and copd based on the demographic changes in the netherlands. in addition, for mi and dm the effect of a rise in overweight was calculated. methods: calculations were made for the period - with a dynamic multi-state transition model and demographic projections of the cbs. results: based on ageing alone, between and prevalence of dm will rise from . to . (+ %), prevalence of mi from . to . (+ %), stroke prevalence from . to . (+ %) and copd prevalence from . to . (+ %). a continuation of the dutch (rising) trend in overweight prevalence would in lead to about . diabetics (+ %). a trend resulting in american levels would lead to over million diabetics (+ %), while the impact on mi was much smaller: about . (+ %) in . conclusion: the burden of chronic disease will substantially increase in the near future. a rising prevalence of overweight has an impact especially on the future prevalence of diabetes background: there has been increasing concern about the effects of environmental endocrine disruptors (eeds) on human reproductive health. eeds include various industrial chemicals, as well as dietary phyto-estrogens. intra-uterine exposures to eeds are hypothesized to disturb normal foetal development of male reproductive organs and specifically, to increase the risk of cryptorchidism, hypospadias, testicular cancer, and a reduced sperm quality in offspring. objective: to study the associations between maternal and paternal exposures to eeds and the risks of cryptorchidism, hypospadias, testicular cancer and reduced sperm quality. design and methods: these associations are studied using a case-referent design. in the first phase of the study, we collected questionnaire data of the parents of cases with cryptorchidism, cases with hypospadias and referent children. in the second phase, we will focus on the health effects at adult age: testicular cancer and reduced sperm quality. in both phases, we will attempt to estimate the total eed exposure of parents of cases and referents at time of pregnancy through an exposure-assessment model in which various sources of exposure, e.g. environment, occupation, leisure time activities and nutrition, are combined. in addition, we will measure hormone receptor activity in blood. background: eleven percent of the pharmacotherapeutic budget is spent on acid-suppressive drugs (asd); % of patients are chronic user. most of these indications are not conform to dyspepsia guidelines. objectives: we evaluated the implementation of an asd rationalisation protocol among chronic users, and analysed effects on volume and costs. method: in a cohort study patients from gp's with protocol were compared to a control group of patients from gp's without. prescription data of - were extracted from agis health database. a log-linear regression model compared standardised outcomes of number of patients that stopped or reduced asd (> %) and of prescription volume and costs. results: gp's and patients in both groups were comparable. % in the intervention group had stopped; % in the control group (p< . ). the volume had decreased in another % of patients; % in control group (p< . ). compared to the baseline data in the control group ( %) the adjusted or of volume in the intervention group was . %. the total costs adjusted or was . %. the implementation significantly reduced the number of chronic users, and substantially dropped volume and costs. active intervention from insurance companies can stimulate rationalisation of prescription. background/objective: today, % of lung cancers are resectable (stage i/ii). -year survival is therefore low ( %). spiral computed tomography (ct) screening detects more lung cancers than chest x-ray. it is unknown if this will translate into a lung cancer mortality reduction. the nelson trial investigates whether detector multi-slice ct reduces lung cancer mortality with at least % compared to no screening. we present baseline screening results. methods: a questionnaire was sent to , men and women. of the , respondents, , high-risk current and former smokers were invited. until december , , , of them gave informed consent and were randomised ( : ) in a screen arm (ct in year , and ) and control arm (no screening). data will be linked with the cancer registry and statistics netherlands to determine cancer mortality and incidence. results: of the first , baseline ct examinations % was negative (ct after one year), % indeterminate (ct after months) and % positive (referral pulmonologist). seventy percent of detected tumours were resectable. conclusion/discussion: ct screening detects a high percentage of early stage lung cancers. it is estimated that the nelson trial is sufficiently large to demonstrate a % lung cancer mortality reduction or more. background: due to diagnostic dilemmas in childhood asthma, drug treatment of young children with asthmatic complaints often serves as a trial treatment. objective: to obtain more insight into patterns and continuation of asthma medication in children during the first years of life. design: prospective birth cohort study methods: within the prevention and incidence of asthma and mite allergy (piama) study (n = , children) we identified children using asthma medication in their first year of life. results: about % of children receiving asthma medication before the age of one, discontinued use during follow-up. continuation of therapy was associated with male gender (adjusted odds ratio [aor] . , % confidence interval [ci]: . - . ), a diagnosis of asthma (aor . , % ci: . - . ) and receiving combination or controller therapy (aor , , % ci: . - . ). conclusion: patterns of medication use in preschool children support the notion that both beta -agonist and inhaled corticosteroids are often used as trial medication, since % discontinues. the observed association between continuation of therapy and both an early diagnosis of asthma and a prescription for controller therapy suggests that, despite of diagnostic dilemmas, children in apparent need of prolonged asthma therapy are identified at this very early age. background: this study explored the differences in birthweight between infants of first and second generation immigrants and infants of dutch women, and to what extent maternal, fetal and environmental characteristics could explain these differences. method: during months all pregnant women in amsterdam attending their first prenatel screening were asked to fill out a questionnaire (sociodemographic status, lifestyle) as part of the amsterdam born children and their development (abcd)-study; women ( %) responded. only singleton deliveries with pregnancy duration = weeks were included (n = ). results: infants of all first and second generation immigrant groups (surinam, the antilles, turkey, morocco, ghana, other countries) had lower birthweights (range: - gram) than dutch infants ( gram). linear regression revealed that, adjusted for maternal height, weight, age, parity, smoking, marital status, gestational age and gender, infants of surinamese women ( st and nd generation), antillean and ghanaian women (both st generation) were still lighter than dutch infants ( . , . , . , and . grams respectively; p< . ). conclusion: adjusted for maternal, fetal and environmental characteristics infants of some immigrant groups had substantial lower birthweights than infants of dutch women. other factors (like genetics, culture) can possibly explain these differences. introduction: missing data is frequently seen in cost-effectiveness analyses (ceas). we applied multiple imputation (mi) combined with bootstrapping in a cea. objective: to examine the effect of two new methodological procedures of combining mi and bootstrapping in a cea with missing data. methods: from a trial we used direct health and non-health care costs and indirect costs, kinesiophobia and work absence data assessed over months. mi was applied by multivariate imputation by chained equations (mice) and non-parametric bootstrapping was used. observed case analyses (oca), where analyses were conducted on the data without missings, were compared with complete case analysis (cca) and with analyses when mi and bootstrapping were combined after to % of cost and effect data were omitted. results: by the cca effect and cost estimates shifted from negative to positive and cost-effectiveness planes and acceptability curves were biased compared to the oca. the methods of combining mi and bootstrapping generated good cost and effect estimates and the cost-effectiveness planes and acceptability curves were almost identical to the oca. conclusion: on basis of our study results we recommend to use the combined application of mi and bootstrapping in data sets with missingness in costs and effects. background: since the s, coronary heart disease (chd) mortality rates have halved with approximately % of this decrease being attributable to medical and surgical treatments. objective: this study examined the cost-effectiveness of specific chd treatments. design and methods: the impact chd model was used to calculate the number of life-years-gained (lyg) by specific cardiology interventions given in , and followed over ten years. this previously validated model integrates data on patient numbers, median survival in specific groups, treatment uptake, effectiveness and costs of specific interventions. cost-effectiveness ratios were generated as costs per lyg for each specific intervention. results: in , medical and surgical treatments together prevented or postponed approximately , chd deaths in patients aged - years; this generated approximately , extra life years. aspirin and beta-blockers for secondary prevention of myocardial infarction and heart failure, and spironolactone for heart failure all appeared highly cost-effective (<e , per lyg). less cost effective, however, were revascularisation for chronic angina (cabg surgery e , and angioplasty e , per lyg), or statins for primary prevention (e , per lyg) or for community patients with angina (e , per lyg). conclusions: cost effectiveness ratios generally favoured simple medical treatments for myocardial infarction, secondary prevention, and heart failure. objective: is population-based primary prevention more favourable than secondary prevention (risk factor reduction in coronary heart disease (chd) patients)? methods: the previously validated im-pact model was used to integrate data describing chd patient numbers, specific treatment uptake levels, trends in major risk factors, and the mortality benefits of these risk factor changes in healthy people and in chd patients. results: approximately , fewer deaths were attributable to reductions in the three major risk factors between and . declining smoking prevalence resulted in approximately fewer deaths: in healthy people and in known chd patients. decreasing population total cholesterol concentrations resulted in approximately , fewer deaths attributable to dietary changes ( , in healthy people and in chd patients) plus fewer deaths attributable to statin treatment ( in people without chd and in chd patients). decreasing mean population blood pressure resulted in approximately fewer deaths attributable to secular falls in blood pressure ( in healthy people and in chd patients) plus approximately fewer deaths attributable to antihypertensive treatments in people without chd. conclusions: compared with secondary prevention ( fewer deaths), primary prevention ( , fewer deaths) achieved a three-fold larger reduction in chd deaths. background: carotenoid intake has been positively associated with plasma concentrations in different populations. however, the influence of body mass index (bmi) on this association is mostly unknown. objectives: we explored the relationship between intake of carotenoids and vitamin c, and their plasma concentrations by bmi categories in spanish elderly people. desgin/methods: a dietary interview using a -item food-frequency questionnaire was conducted with men and women, and older, participating in the eureye study in spain. blood samples were collected for measurement of carotenoids and vitamin c. correlation coefficients (r) between energy adjusted nutrient intakes and plasma concentrations were calculated by categories of bmi, adjusting for sex, age and smoking. results: significant correlations between acarotene, ß-carotene, lycopene, ß-cryptoxanthin and vitamin c intakes, and plasma concentrations were observed, r= . ; . ; . ; . , . , respectively (p< . ). correlations for carotenoids changed substantially by bmi categories, with the highest correlations for a-carotene, ß-carotene, and, to a lesser extension, ß-cryptoxanthin and lycopene, in subjects with bmi< ( . ; . ; . ; . respectively), and the lowest, in subjects with bmi= ( . ; . ; . ; . respectively). correlations for vitamin c remained unchanged by bmi. conclusions: our data suggest that carotenoids in plasma may be good markers of dietary intake in elderly subjects with lower bmi. background: reduced heart rate variability (hrv) is associated with an increased mortality, morbidity and worse prognosis of cardiovascular diseases (cvd). there is a lack of population-based data to examine the distribution of hrv, its association with cardiovascular risk factors (cvrf), and its role as a potential mediator of the effect of established risk factors on cvd. objective: to study the distribution of hrv and its association with cvrf in an elderly eastern german population. design and methods: this analysis is based on data of participants ( - years) of an ongoing cross-sectional study. time-and frequency-domain measures of hrv were computed. their association with cvrf was determined by linear regression modelling. results: age-and heart rate-adjusted standard deviation of the durations of nn intervals and high frequency power was significantly higher in women. significant inverse associations of timeand frequency-domain hrv with anthropometric parameters, triglycerides, blood pressure, prevalent diabetes and age were observed in both sexes. there was a graded inverse association of hrv with age except for the oldest age-group. discussion/conclusion: established cvrf are associated with a reduced hrv. therefore reduced hrv could be a mediator between cvrf and cvd, which will be examined in a follow-up study. background: aalen's model and cox's proportional hazard model postulate different relationship between hazard and covariates and the subject matter seldom suggests which of the models are to be preferred. actually the assumption of constant effects, either additive or multiplicative, may be incorrect especially in cancer survival analysis. objectives: the aim of the study is to analyse survival for a breast cancer cohort where typical prognostic factors lack of proportionality. design and methods: the cohort consists of invasive breast cancer cases from turin cancer registry within a high resolution study in co-operation with the breast cancer screening program, diagnosed from through , aged - . an additive-multiplicative cox-aalen model with age at diagnosis, categorized tumour size (t) and nodal status (n) is fitted. results: the prognostic role of age at diagnosis, t and n are confirmed. proportionality assumption holds only for age (hazard ratio = . , p-value< . ). t, particularly the category referring to 'extended to chest wall or skin' versus 'less than cm', has a significant time-varying effect (p-value = . ) after months since diagnosis. discussion: more flexible regression tools than cox model which is routinely used for analyzing cancer survival are needed. cox-aalen proves to be an appealing alternative. background: the major software packages for meta-analysis of causal -notably intervention -research are generally too expensive for developing countries. moreover, interactive educational software for students and teachers is largely unavailable. we recently developed the 'mix' program, an easy-to-maintain, interactive, and educational meta-analysis add-in for excel, available as free download at http://www.mix-for-meta-analysis.info. objectives: to formally establish whether the program's numerical and graphical output is comprehensive and accurate enough for scientific standards. design and methods: the study was designed as a software validation. data sets, primarily intervention studies, with substantially different features were analyzed by three investigators with mix and stata, using the latter program as golden standard. additionally, a feature (software options) comparison was made with modern programs for meta-analysis, such as cma . , metawin . , weasyma . , and revman . . results: the results of the validation project will be fully reported at the congress. preliminary results indicate that the mix program's output is comparable to stata output. it distinguishes itself from other software by the variety of graphical output, the excel-based interface, and free availability. conclusion and discussion: the mix program appears to provide valid output and may be an attractive, feature-rich alternative to existing meta-analysis software. background: an ankle-arm index (aai) < . of systolic blood pressure (sbp) as marker of peripheral arterial disease is a predictor of coronary and carotid artery disease. the present gold standard examination with doppler-ultrasound and sphygmomanometric cuff is subject to observer bias and requires intensive training. for epidemiologic studies, valid and easy-to-use examination methods are needed. objective: to validate the easy-to-use omron hem- cp for sbp measurements in the ankle and for aai determination in epidemiologic studies. design/methods: in a population-based sample of subjects ( - years), arm and ankle sbp measurements by the omron hem- cp and corresponding aai were compared with those using a hand-held doppler and sphygmomanometric cuff. bland-altman plots of sbp and aai differences, validation criteria for use in clinical practice and diagnostic values for the detection of an aai< . were employed. results: omron measured higher sbp than doppler. sbp and aai differences increasing towards higher sbp levels. specificity, sensitivity and negative predictive value for the detection of aai< . were > % (positive predictive value was %). conclusion: omron fails the validation criteria for ankle sbp measurement. however, the ease of use of the device could outweigh the inaccuracy if used as a screening tool for aai< , in epidemiologic studies. background: associations exist between: ) parental birth weight and child birth weight; ) birth weight and adult psychopathology; and ) maternal psychopathology during pregnancy and birth weight of the child. this study is the first to combine those associations. objective: to investigate the different pathways from parental birth weight and parental psychopathology to child birth weight in one model. design and methods: depression and anxiety scores on , mothers and , fathers during weeks pregnancy and birth weights from , children were available. path analyses with standardized regression coefficients were used to evaluate the different effects. results: in the unadjusted path analyses significant effects existed between: maternal (r = . ) and paternal birth weight (r = . ) and child birth weight; maternal birth weight and maternal depression (r=). ) and anxiety (r=). ); and maternal depression (r = . ) and anxiety (r = . ) and child birth weight. after adjustment for confounders, only maternal (r = . ) and paternal (r = . ) birth weight and maternal depression (r=). ) remained significantly related to child birth weight. conclusion after adjustment maternal depression, and not anxiety, remained significantly related to child birth weight. discussion future research should focus on the different mechanisms of maternal anxiety and depression on child birth weight. background: most patients with peripheral arterial disease (pad) die from coronary artery disease (cad). non-invasive cardiac imaging can assess the presence of coronary atherosclerosis and/or cardiac ischemia. screening in combination with more aggressive treatment may improve prognosis. objective: to evaluate whether a non-invasive cardiac imaging algorithm, followed by treatment will reduce the -year-risk of cardiovascular events in pad patients free from cardiac symptoms. design and methods: this is a multicenter randomized controlled clinical trial. patients with intermittent claudication and no history of cad are eligible. one group will undergo computed tomography (ct) calcium scoring. the other group will undergo ct calcium scoring and ct angiography (cta) of the coronary arteries. patients in the latter group will be scheduled for a dobutamine stress magnetic resonance imaging (dsmr) test to assess cardiac ischemia, unless a stenosis of the left main (lm) coronary artery (or its equivalent) was found on cta. patients with cardiac ischemia or a lm/lm-equivalent stenosis will be referred to a cardiologist, who will decide on further (interventional) treatment. patients are followed for years. conclusion: this study assesses the value of non-invasive cardiac imaging to reduce the risk of cardiovascular events in patients with pad free from cardiac symptoms. background: hpv is the main risk factor for cervical cancer and also a necessary cause for it. participation rates in cervical cancer screening are low in some countries and soon hpv vaccination will be available. objectives: aim of this systematic review was to collect and analyze published data on knowledge about hpv. design and methods: a medline search was performed for publications on knowledge about hpv as a risk factor for cervical cancer and other issues of hpv infection. results: of individual studies were stratified by age of study population, country of origin, study size, publication year and response proportion. heterogeneity was described. results: knowledge between included studies varied substantially. thirteen to % (closed question) and . to . % (open question) of the participants knew about hpv as a risk factor for cervical cancer. women had consistently better knowledge on hpv than men. there was confusion of hpv with other sexually transmitted diseases. conclusion and discussion: studies were very heterogeneous, thus making comparison difficult. knowledge about hpv infections depended on the type of question used, gender of the participants and their professional background. education of the general public on hpv infections needs improvement, specially men should also be addressed. background: influenza outbreaks in hospitals and nursing homes are characterized by high attack rates and severe complications. knowledge of the virus' specific transmission dynamics in healthcare institutions is scarce but essential to develop cost-effective strategies. objective: to follow and model the spread of influenza in two hospital departments and to quantify the contributions of the several possible transmission pathways. methods: an observational prospective cohort study is performed on the departments of internal medicine & infectious diseases and pulmonary diseases of the umc utrecht during the influenza season. all patients and regular medical staff are checked daily on the presence of fever and cough, the most accurate symptoms of influenza infection. nose-throat swabs are taken for pcr analysis for both symptomatic individuals and a sample of asymptomatic individuals. to determine transmission, contact patterns are observed between patients and visitors and patients and medical staff. results/discussion: spatial and temporal data of influenza cases will be combined with contact data in a mathematical model to quantify the main transmission pathways. among others the model can be used to predict the effect of vaccination of the medical staff which is not yet common practice in the studied hospital. background: the long term maternal sequelae of stillbirths is unknown. objectives: to assess whether women who experienced stillbirths have an excess risk of long term mortality. study design: cohort study. methods: we traced jewish women from the jerusalem perinatal study, a population-based database of all births to west jerusalem residents ( - who gave birth at least twice during the study period, using unique identity numbers. we compared the survival to - - of women who had at least one stillbirth (n = ) to that of women who had only live births (n = ) using cox proportional hazards models. results: during a median follow up of . years, ( . %) mothers with stillbirths died compared to , ( . %) unexposed women; crude hazard ratio (hr) . ( % ci: . - . ). the mortality risk remained significantly increased after adjustments for sociodemo-graphic variables, maternal diseases, placental abruption and preeclampsia (hr: . , % ci: . - . ). stillbirth was associated with increased risk of death from cardiovascular (adjusted hr: . , . - . ), circulatory ( . , . - . ) and genitourinary ( . , . - . ) causes. conclusions: the finding of increased mortality among mothers of stillbirths joins the growing body of evidence demonstrating long term sequelae of obstetric events. future studies should elucidate the mechanisms underlying these associations. resilience is one of the essential characteristics of successful ageing. however, very little is known about the determinants of resilience in old age. our objectives were to identify resilience in the english longitudinal study of ageing (elsa) and to investigate social and psychological factors determining it. the study design was a crosssectional analysis of wave of elsa. using structural equation modelling, we identified resilience as a latent variable indicated by high quality of life in the face of six adversities: ageing, limiting long-standing illness, disability, depression, perceived poverty and social isolation and we regressed it on social and psychological factors. the latent variable model for resilience showed a highly significant degree of fit (weighted root mean square resid-ual= . ). determinants of resilience included good quality of relationships with spouse (p = . ), family (p = . ), and friends (p< . ), good neighbourhood (p< . ), high level of social participation (p< . ), involvement in leisure activities (p = . ); perception of not being old (p< . ); optimism (p = . ), and high subjective probability of survival to an older age (p< . ). we concluded that resilience in old age was as much a matter of social engagement, networks and context as of individual disposition. implications of this on health policy are discussed. background: there is extensive literature concluding that ses is inversely related to obesity in developed countries. several studies in developing populations however reported curvilinear or positive association between ses and obesity. objectives: to assess the social distribution of obesity in men and women in middle-income countries of eastern and central europe with different level of economic development. methods: random population samples aged - years from poland, russia and czech republic were examined between - as baseline for prospective cohort study. we used body-mass index (bmi) and waist/hip ratio (whr) as obesity measures. we compared age-adjusted bmi and whr for men and women by educational levels in all countries. results: the data collection was concluded in summer . we collected data from about , subjects. lower ses increased obesity risk in women in all countries (the strongest gradient in the czech republic and the lowest in russia), and in czech men. there was no ses gradient in bmi in polish men and positive association between education and bmi in russian men. conclusions: our findings strongly agree with previous literature showing that the association between ses status and obesity is strongly influenced by overall level of country economic development. background: inaccurate measurements of body weight, height and waist circumference will lead to an inaccurate assessment of body composition, and thus of the general health of a population. objectives: to assess the accuracy of self-reported body weight, height and waist-circumference in a dutch overweight working population. design and methods: bland and altman methods were used to examine the individual agreement between self-reported and measured body weight and height in overweight workers ( % male; mean age . +/) . years; mean body mass index [bmi] . +/) . kg/m ). the accuracy of self-reported waistcircumference was assessed in a subgroup of persons ( % male; mean age . +/) . years; mean bmi . +/) . kg/ m ), for whom both measured and self-reported waist circumference was available. results: body weight was underreported by a mean (standard deviation) of . ( . ) kg, body height was on average over-reported by . ( . ) cm. bmi was on average underreported by . ( . ) kg/m . waist-circumference was overreported by . ( . ) cm. the overall degree of error from selfreporting was between . and . %. conclusion and discussion: self-reported anthropometrics seem satisfactorily accurate for the assessment of general health in a middle-aged overweight working population. the incidence of breast cancer and the prevalence of metabolic syndrome are increasing rapidly in chile, but this relationship is still debated. the goal of this study is to assess the association between metabolic syndrome and breast cancer before and after menopause. a hospital based case-control study was conducted in chile during . cases with histologically confirmed breast cancer and age matched controls with normal mammography were identified. metabolic syndrome was defined by atpiii and serum lipids, glucose, blood pressure and waist circumference were measured by trained nurses. data of potential confounders such as, obesity, socioeconomic status, exercise and diet were obtained by anthropometric measures and a questionnaire. odds ratios (ors) and % confidence intervals (cis) were estimated by conditional logistic regression stratified by menopause. in postmenopausal women, a significant increase risk of breast cancer was observed in women with metabolic syndrome (or = . , % ci = . - . ). the elements of metabolic syndrome strongly associated were high levels of glucose and hypertension. in conclusion, postmenopausal women with metabolic syndrome had % of excess risk of breast cancer. these findings support the theory that there is a different risk profile of breast cancer after and before menopause. background: physical exercise during pregnancy has numerous beneficial effects on maternal and foetal health. it may, however, affect early foetal survival negatively. objectives: to examine the association between physical exercise and spontaneous abortion in a cohort study. design and methods: in total, , women recruited to the danish national birth cohort in early pregnancy, provided information on amount and type of exercise during pregnancy and on possible confounding factors. , women experienced foetal death before gestational weeks. hazard ratios for spontaneous abortion in four periods of pregnancy () , - , - , and - weeks) according to amount (min/week) and type of exercise, respectively, were estimated using cox regression. various sensitivity analyses to reveal distortion of the results from selection forces and information bias were made. results: the hazard ratios of spontaneous abortion increased stepwise with amount of physical exercise and were largest in the earlier periods of pregnancy (hrweek - = . (ci . - . ) for min/week, compared to no exercise). weight bearing types of exercise were strongest associated with abortion, while swimming showed no association. these results remained stable, although attenuated, in the sensitivity analyses. discussion: handling of unexpected findings that furthermore challenge official public health messages will be discussed. hemodialysis (hd) patients with a low body mass index (bmi) have an increased mortality risk, but bmi changes over time on dialysis treatment. we studied the association between changes in bmi and all-cause mortality in a cohort of incident hd patients. patients were followed until death or censoring for a maximum follow-up of years. bmi was measured every months and changes in bmi were calculated over each -mo period. with a time-dependent cox regression analysis, hazard ratios (hr) were calculated for these -mo changes on subsequent mortality from all causes, adjusted for the mean bmi of each -mo period, age, sex and comorbidity. men and women were included (age: ? years, bmi: . ? . kg/m , -y mortality: %). a loss of bmi> % was independently associated with an increased mortality risk (hr: . , %-ci: . - . ), while a loss of - % showed no difference (hr: . , . - . ) compared to no change in bmi () % to + % change). a gain in bmi of - % showed beneficial (hr: . , . - . ), while a gain of bmi> % was not associated with a survival advantage (hr: . , . - . ). in conclusion, hd patients with a decreasing bmi have an increased risk of all-cause mortality. background: within the tripss- project, impact of clinical guidelines (gl) on venous thromboembolism (vte) prophylaxis was evaluated in a large italian hospital. gl were effective in increasing the appropriateness of prophylaxis and in reducing vte. objectives: we performed a cost-effectiveness analysis by using a decision-tree model to estimate the impact of the adopted gl on costs and benefits. design and methods: a decision-tree model compared prophylaxis cost and effects before and after gl implementation. four risk profiles were identified (low, medium, high, very high). possible outcomes were: no event, major bleeding, asymptomatic vte, symptomatic vte and fatal pulmonary embolism. vte patients risk and probability of receiving prophylaxis were defined using data from the previous survey. outcome probabilities were assumed from literature. tariffs and hospital figures were used for costing the events. results: gl introduction reduced the average cost per patient from e to () %) with an increase in terms of event free patients (+ %). results are particularly relevant in the very high risk group. conclusion: the implementation of locally adapted gl may lead to a gain in terms of costs and effects, in particular for patients at highest vte risk. background: assisted reproductive techniques are used to overcome infertility. one reason of success is the use of ovarian stimulation. objectives: compare two ovarian stimulation protocols, gonadotropin-releasing hormone agonists/antagonists, assessing laboratorial and clinical outcomes, to provide proper therapy option. identify significant predictors of clinical pregnancy and ovarian response. design and methods: retrospective study (agonist cycles, ; antagonist cycles, ) including ivf/intracytoplasmic sperm injection cycles. multiple logistic and regression models, with fractional polynomial method were used. results: antagonist group exhibited lower length of stimulation and dose of recombinant follicle stimulating hormone (rfsh), higher number of retrieved and fertilized oocytes, and embryos. agonist group presented thicker endometrium, better fertilization, implantation and clinical pregnancy rates. clinical pregnancy has shown positive correlation with endometrial thickness and use of agonist; negative correlation with age and number of previous attempts. retrieved oocytes shown positive correlation with estradiol on day of human chorionic gonadotrophin (hcg) and use of antagonist; negative correlation with rfsh dose. conclusion: patients from antagonist group are more likely to get more oocytes and quality embryos, despite those from agonist group are more likely to get pregnant. background: prevalence studies of the metabolic syndrome require fasting blood samples and are therefore lacking in many countries including germany. objectives: to narrow the incertitude resulting from extrapolation of international prevalence estimates, with a sensitivity analysis of the prevalence of the metabolic syndrome in germany using a nationally representative but partially non-fasting sample. methods: stepwise analysis of the german health examination survey , using the national cholesterol education program (ncep) criteria, hemoglobin a c (hba c), non-fasting triglycerides and fasting time. results: among participants aged - years, the metabolic syndrome prevalence was (i) . % with . % inconclusive cases using the unmodified ncep criteria, (ii) . % with . % inconclusive cases using hba c > . % if fasting glucose was missing, (iii) . % with . % inconclusive cases when additionally using non-fasting triglycerides = th percentile stratified by fasting time, and (iv) . % to . % with < % inconclusive cases using different cutoffs (hba c . %, non-fasting triglycerides and mg/dl). discussion: despite a lower prevalence of obesity in germany compared to the us, the prevalence of the metabolic syndrome is likely to be in the same order of magnitude. this analysis may help promote healthy life styles by stressing the high prevalence of interrelated cardiovascular risk factors. background: epidemiologic studies that directly examine fruits and vegetables (f&v) consumption and other lifestyle factors in relation to weight gain are sparse. objective: we examined the associations between the f&v intake and -y weight gain among spanish adult people. design/methods: the study was conducted with a sub-sample of healthy people aged y and over at baseline in , who participated in a population-based nutrition survey in valencia-spain. data on diet, lifestyle factors and body weight (direct measurement) were obtained in and . information on weight gain was available for participants in . results: during the -y period, participants tended to gain on average . kg (median = . kg). in multivariate analyses, participants with the highest tertile of f&v intake at baseline had a % of lower risk of gaining = . kg compared with those who had the lowest intake tertile after adjustment for sex, age, education, smoking, tv-viewing, bmi, and energy intake (or = . ; % ci: . . ;p-fortrend = . ). for every g/d increase in f&v intake, the or was reduced by % (or = . ; . - . ;p-trend= . ). tvviewing at baseline was positively associated with weight gain, or for- h-increase= . ( . - . ;p-trend= . ). conclusions: our findings suggest that a high f&v intake and low tv-viewing may reduce weight gain among adults. background: diabetic patients develop more readily atherosclerosis thus showing greatly increased risk for cardiovascular disease. objective: the heinz nixdorf recall-study is a prospective cohort-study designed to assess the prognostic value of new risk stratification methods. here we examined the association between diabetes, previously unknown hyperglycemia and the degree of coronary calcification (cac). methods: a population-based sample of , men and women aged - years was recruited from three german cities between - . baseline examination included amongst others a detailed medical history, blood analyses and electron-beam tomography. we calculated adjusted prevalence ratios (pr), adjusting for age, smoking, bmi and %-confidence intervals ( % ci) with log-linear binomial regression. results: the prevalence of diabetes is . % (men: . %, women: . %), for hyperglycemia . % (men: . %, women: . %). prevalence ratio for cac in male diabetics without overt coronary heart disease is . ( % ci: . - . ), for those with hyperglycemia . ( . - . ). in women the association is even stronger: . ( . - . ) with diabetes, . ( . - . ) with hyperglycemia. conclusion: the data support the concept of regarding diabetic patients as being in a high risk category meaning > % hard events in years. furthermore, even persons with elevated blood glucose levels already show higher levels of coronary calcification. background: birth weight is associated with health in infancy and later in life. socioeconomic inequality in birth weight is an important marker of current and future population health inequality. objective: to examine the effect of maternal education on birth weight, low birth weight (lbw, birth weight< , g), and small for gestational age (sga) background: in clinical practice patient data are obtained gradually and health care practitioners tune prognostic information according to available data. prognostic research does not always reproduce this sequential acquisition of data: instead, 'worst', discharge or aggregate data are often used. objective: to estimate prognostic performance of sequentially updated models. methods: cohortstudy of all very-low-birth-weight-babies (< g) admitted to the study neonatal icu < days after birth ( eligible from to ) and followed-up until years old ( . % lost-to-follow-up). main outcomes: disabling cerebral palsy at years ( , . %) or death ( , . % ) % in the first weeks). main prognostic determinants: neonatal cerebral lesions identified with cranial ultrasound (us) exams performed per protocol on days , , and at discharge. logistic regression models were updated with data available at these different moments in time during admission. results: at days , and respectively, main predictor (severe parenchymal lesion) adjusted odds ratio: , and ; us model c-statistic: . , . and . . discussion: prognostic models performance in neonatal patients improved from inception to discharge, particularly for identification of the high risk category. time of data acquisition should be considered when comparing prognostic instruments. in epidemiological longitudinal studies one is often interested in the analysis of time patterns of censored history data. for example, how regular a medication is used or how often someone is depressed. our goal is to develop a method to analyse time patterns of censored data. one of the tools in longitudinal studies is a nonhomogeneous markov chain model with discrete time moments and categorical state space (for example, use of various medications). suppose we are interested only in the time pattern of appearance of a particular state which is in fact a certain epidemiological event under study. for this purpose we construct a new homogeneous markov chain associated with this event. the states of this markov chain are the time moments of the original nonhomogeneous markov chain. using the new transition matrix and standard tools from markov chain theory we can derive the probabilities of occurence of that epidemiological event during various time periods (including ones with gaps). for example, probabilities of cumulative use of medication during any time period. in conclusion, the proposed approach based on markov chain model provides a new way of data representation and analysis which is easy to interpret in practical applications. background: tuberculosis (tb) cases that belong to a cluster of the same mycobacterium tuberculosis dna fingerprint are assumed to be consequence of recent transmission. targeting interventions to fast growing clusters may be an efficient way of interrupting transmission in outbreaks. objective: to assess predictors for large growing clusters compared to clusters that remain small within a years period. design and method out of the culture confirmed tb patients diagnosed between and , ( %) had unique fingerprints while were part of a cluster. of the clustered cases were in a small ( to cases within the first years) and in a large cluster (more than cases within the first years). results independent risk factors for being a case within the first years of a large cluster were non-dutch nationality (or = . % ci [ . - . background: passive smoking causes adverse health outcomes such as lung cancer or coronary heart disease (chd). the burden of passive smoking on a population level is currently unclear and depends on several assumptions. we investigated the public health impact of passive smoking in germany. methods: we computed attributable mortality risks due to environmental tobacco smoke (ets). we considered lung cancer, chd, stroke, copd and sudden infant death. frequency of passive smoking was derived from the national german health survey. sensitivity analyses were performed using different definitions of exposure to passive smoking. results: in total, deaths every year in germany are estimated to be caused by exposure to passive smoking at home (women , men ). most of these deaths are due to chd ( ) and stroke ( ). additional consideration of passive smoking at workplace increased the number of deaths to . considering any exposure to passive smoking and also active smokers who report exposure to passive smoking increased the number of deaths further. conclusions: passive smoking has an important impact on mortality in germany. even the most conservative estimate using exposure to ets at home led to a substantial number of deaths related to passive smoking. des daughters have a strongly increased risk of clear-cell adenocarcinoma of the vagina and cervix (ccac) at a young age. longterm health problems, however, are still unknown. we studied incidence of cancer, other than ccac, in a prospective cohort of des daughters (desnet project). in , questionnaires were sent to des daughters registered at the des center in utrecht. also, informed consent was asked for linkage with disease registries. for this analysis, data of , responders and nonresponders were linked to palga, the dutch nationwide network and registry of histo-and cytopathology. mean age at the end of follow-up was . years. a total of incident cancers occurred. increased standardized incidence rates (sir) were found for vaginal/vulvar cancers (sir = . , % confidence interval ( % ci) . - . ), melanoma (sir = . , % ci . - . )) and breast cancer (sir= . , % ci . - . ) as compared to the general population. no increased risk was found for invasive cervical cancer, possibly due to effective screening. results for breast and cervical cancer are consistent with the sparse literature. the risk of melanoma might be due to surveillance bias. future analyses will include non-invasive cervical cancer, stage specific sirs for melanoma and adjustment for confounding (sister control group) for breast cancer. background: contact tracing plays an important role in the control of emerging infectious diseases in both human and farm animal populations, but little is known yet about its effectiveness. here we investigate in a generic setting for well-mixed populations the dependence of tracing effectiveness on the probability that a contact is traced, the possibility of iteratively tracing yet asymptomatic infectives, and delays in the tracing process. methods and findings: we investigate contact tracing in a mathematical model of an emerging epidemic, incorporating a flexible infectivity function and incubation period distribution. we consider isolation of symptomatic infected as the basic scenario, and determine the critical tracing probability (needed for effective control) in relation to two infectious disease parameters: the reproduction ratio under isolation and the duration of latent period relative to the incubation period. the effect of tracing delays is considered, as is the possibility of single-step tracing vs. iterative tracing of quarantined invectives. finally, the model is used to assess the likely success of tracing for influenza, smallpox, sars, and foot-and-mouth disease epidemics. conclusions: we conclude that single-step contact tracing can be effective for infections with a relatively long latent period or a large variation in incubation period, thus enabling backwards tracing of super spreading individuals. the sensitivity to changes in the tracing delay varies greatly, but small increases may have major consequences for effectiveness. if single-step tracing is on the brink of being effective, iterative tracing can help, but otherwise it will not improve much. we conclude that contact tracing will not be effective for influenza pandemics, only partially for fmd epidemics, and very effective for smallpox and sars epidemics. abstract: infections of highly pathogenic h n avian influenza in humans underline the need for tracking of the ability of these viruses to spread among humans. here we propose a method of analysing outbreak data that allows determination of whether and to what extent transmission in a household has occurred after an introduction from the animal reservoir. in particular, it distinguishes between onward transmission from humans that were infected from the animal reservoir (primary human-to-human transmission) and onward transmission from humans who were themselves infected by humans (secondary human-to-human transmission). the method is applied to data from an epidemiological study of an outbreak of highly pathogenic avian influenza (h n ) in the netherlands in . we contrast a number of models that differ with respect to the assumptions on primary versus secondary human-to-human transmission. session: mathematical modelling of infectious diseases presentation: oral. usually models for the spread of an infection in a population are based on the assumption of a randomly mixing population, where every individual may contact every other individual. however, the assumption of random mixing seems to be unrealistic, therefore one may also want to consider epidemics on (social) networks. connections in the network are possible contacts, e.g. if we consider sexually transmitted diseases and ignore all spread by other than sexual ways, the connections are only between people that may have intercourse with each other. in this talk i will compare the basic reproduction ratio, r and the probability of a major outbreak of network models and for randomly mixing populations. furthermore, i will discuss which properties of the network are important and how they can be incorporated in the model. in this talk a reproductive power model is proposed that incorporates the following points met when an epidemic disease outbreak is modeled statistically: ) the dependence of the data is handled with a non-homogeneous birth process. ) the first stage of the outbreak is described with an epidemic sir model. soon control measures will start to influence the process. these measures are in addition to the natural epidemic removal process. the prevalence is related to the censored infection times in such a way that the distribution function, and therefore the survival function, satisfies approximately the first equation of the sir model. this leads in a natural way to the burr-family of distributions. ) the non-homogeneous birth process handles the fact that in practice, with some delay, it is the infected that are registered and not the susceptibles. ) finally the ending of the epidemic caused by the measures taken is incorporated by modifying the survival function with a finalsize parameter in the same way as is done in long-term survival models. this method is applied to the dutch classical swine individual and area (municipality) measures of income, marital and employment status were obtained. there were , suicides and , controls. after controlling for compositional effects, ecological associations of increased suicide risk with declining area levels of employment and income and increasing levels of people living alone were much attenuated. individual-level associations with these risk factors were little changed when controlling for contextual effects. we found no consistent evidence that associations with individual level risk factors differed depending on the areas characteristics (cross-level interactions). this analysis suggests the ecological associations reported in previous studies are likely to be due in greater part to the characteristics of the residents in those areas than area-influences on risk, rather than to contextual effects. were found to be at higher risk. risk was significantly greater in women whose first full-term pregnancy was at age or more (or . , ). in addition, more than full-term pregnancies would be expected to correlate with an increase in the risk (x . , p< . ). in multivariate analysis, history of breast feeding is a significant factor in decreasing risk (or . , % ci . - . the euregion meuse-rhine (emr) is an area with different regions, regarding language, culture and law. organisations and institutions received frequently signals about an increasing and region-related consumption of addictive drugs and risky behaviour of adolescents. as a reaction institutions from regions of the emr started a cross-border cooperation project 'risky behaviour adolescents in the emr'. the partners intend to improve the efficiency of prevention programmes by investigating the prevalence and pre-conditional aspects related to risky behaviour, and creating conditions for best-practice-public-health. the project included two phases: study. two cross-border (epidemiological) studies where realized: a quantitative study of the prevalence of risky behaviour ( pupils) and a qualitative study mapped preconditional aspects of risky behaviour and possibilities to preventive programmes. implementation. this served bringing about recommendations on policy level as well as on prevention level. during this phase the planning and realisation of cross-border preventionprogrammes and activities started. there is region-related variance of prevalence in risky-behaviour of adolescents in de emr. also there are essential differences in legislation and regulation, (tolerated) policy, prevention structures, political and organizational priorities and social acceptance toward stimulants. cross-border studies and cooperation between institutions have resulted in best-practice-projects in (border) areas of the emr. abstract background: beta-blockers increase bone strenght in mice and may reduce fracture risk in humans. therefore, we hypothesized that inhaled beta- agonists may increase risk of hip fracture. objective: to determine the association between daily dose of beta- agonist use and risk of hip fractures. methods: a case-control study was conducted among adults who were enrolled in the dutch phar-mo database (n = , ). cases (n = , ) were patients with a first hip fracture. the date of the fracture was the index date. four controls were matched by age, gender and region. we adjusted our analyses for indicators of asthma/copd severity, and for disease and drug history. results: low daily doses (dds) (< ug albuterol eq.) of beta -agonists (crude or . , % ci . - . ) did not increase risk of hip fracture, in contrast to high dds (> ug albuterol eq., crude or . , % ci . . - . ). after extensive adjustment for indicators of the severity of the underlying disease, (including corticosteroid intake), fracture risk in the high dd group decreased to . ( % ci . - . ). conclusions: high dds of beta- agonists are linked to increased risk of hip fracture. extensive adjustments for the severity of the underlying disease is important when evaluating this association. abstract salivary nitrate arises from ingested nitrate and is the main source of gastric nitrite, a precursor of carcinogenic n-nitroso compounds. we examinated the nitrate and nitrite levels in saliva of children who used private wells for their drinking water supply. saliva was collected in the morning, from children aged - years. control group (n = ) drank water containing . - . mg/l (milligrams/litre) nitrate. exposure groups consisting of subjects (n = ) who used private wells with nitrate levels in drinking water below mg/l (mean ± standard deviation . ± . mg/l) and above mg/l (n = ) ( . ± . mg/l) respectively. the nitrate and nitrite of saliva samples was determined by high performance liquid chromatographs method. the values of nitrate in saliva samples from exposed groups ranged between . to . mg/l ( . ± . mg/l). for control groups, the levels of . to . mg/l ( . ± . mg/l) were registered. no differences between levels of salivary nitrite from control and exposed groups were found. regression analysis on water nitrate concentrations and salivary nitrate showed significant correlations. in conclusion, we estimate that salivary nitrate may be used as biomarkers of human exposure to nitrate. abstract disinfection of public drinking water supplies produces trihalomethanes. epidemiological studies have associated chlorinated disinfection by-products with cancer, reproductive and developmental effects. we studied the levels of trihalomethanes (chloroform, dibromochloromethane, bromodichloromethane, bromoform) in drinking water delivered to the population living in some urban areas (n= ). the water samples (n= ) were analysed using gas chromatographic method. assessment of exposure to trihalomethanes in tap water has been on monitoring data collected over - months periods and that we averaged over entire water system. analytical data revealed that total trihalomethanes levels were higher in the summer: mean ± standard deviation . ± . lg/l (micrograms/litre). these organic compounds were present in the end of distribution networks ( . ± . lg/l). it is noted that, sometimes, we found high concentrations of chloroform exceeding the sanitary norm ( lg/l) in tap water (maximum value . lg/l). results of sampling programs showed stronger correlations between chlorine and trihalomethanes value (correlation coefficient r = . to . , credible %interval). in conclusion, the population drank water with the law concentration of trihalomethanes, especially chloroform. abstract objective: to determine the validity of a performance-based assessment of knee function, dynaport[rsymbol] kneetest (dpkt), in first-time consulters with non-traumatic knee complaints in general practice. methods: patients consulting for nontraumatic knee pain in general practice aged years and older were enrolled in the study. at baseline and -months follow-up knee function was assessed by questionnaires and the dpkt; a physical examination was also performed at baseline. hypothesis testing assessed cross-sectional and longitudinal validity of the dpkt. results: a total of patients were included for dpkt of which were available for analysis. the studied population included women ( . %), median age was (range - ) years. at follow-up, patients ( . %) were available for dpkt. only out of ( %) predetermined hypotheses concerning cross-sectional and longitudinal validity were confirmed. comparison of the general practice and secondary care population showed a major difference in baseline characteristics, dynaport knee score, internal consistency and hypotheses confirmation concerning the construct validity. conclusion: the validity of the dpkt could not be demonstrated for first-time consulters with non-traumatic knee complaints in general practice. measurement instruments developed and validated in secondary care are not automatically also valid in primary care setting. abstract although animal studies have described the protective effects of dietary factors supplemented before radiation exposure, little is known about the lifestyle effects after radiation exposure on radiation damage and cancer risks in human. the purpose of this study is to clarify whether lifestyle can modify the effects of radiation exposure on cancer risk. a cohort of , japanese atomic-bomb survivors, for whom radiation dose estimates were currently available, had their lifestyle assessed in . they were followed during years for cancer incidence. the combined effect of smoking, drinking, diet and radiation exposure on cancer risk was examined in additive and multiplicative models. combined effects of a diet rich in fruit and vegetables and ionizing radiation exposure resulted in a lower cancer risk as compared to those with a diet poor in fruit and vegetables and exposed to radiation. similarly, those exposed to radiation and who never drink alcohol or never smoke tobacco presented a lower oesophagus cancer risk than those exposed to radiation and who currently drink alcohol or smoke tobacco. there was no evidence to reject either the additive or the multiplicative model. a healthy lifestyle seems beneficial to persons exposed to radiation in reducing their cancer risks. abstract background: clinical trials have shown significant reduction in major adverse cardiac events (mace) following implantation of sirolimus-eluting (ses) vs. bare-metal stents (bms) for coronary artery disease (cad). objective: to evaluate long-term clinical outcomes and economic implications of ses vs. bms in usual care. methods: in this prospective intervention study, cad patients were treated with bms or ses (sequential control design). standardized patient and physician questionnaires , , and months following implantation documented mace, disease-related costs and patient quality of life (qol). results: patients treated with ses (mean age ± , % male), with bms (mean age ± , % male). there were no significant baseline differences in cardiovascular risk factors and severity of cad. after months, % ses vs. % bms patients had suffered mace (p< . ). initial hospital costs were higher with ses than with bms, but respective month follow-up direct and indirect costs were lower ( , ± vs. , ± euro and ± vs. , ± euro, p = ns). overall, disease-related costs were similar in both groups (ses , ± , bms , ± , p = ns) . differences in qol were not significant. conclusions: as in clinical trials, ses patients experienced significantly fewer mace than bms patients during -month follow-up with similar overall costs and qol. abstract background: meta-analyses that use individual patient data (ipd-ma) rather than published data have been proposed as an improvement in subgroup-analyses. objective: to study ) whether and how often ipd-ma are used to perform subgroup-analyses ) whether the methodology used for subgroup-analyses differs between ipd-ma and meta-analyses of published data (map) methods: ipd-ma were identified in pubmed. related article search was used to identify map on the same objective. metaanalyses not performing subgroup-analysis were excluded from further analyses. differences between ipd-ma and map were analysed, reasons for discrepancies were described. we recently developed a simple diagnostic rule (including history and physical findings plus d-dimer assay results) to safely exclude the presence of deep vein thrombosis (dvt) without the need for referral in primary care patients suspected of dvt. when applied to new patients, the performance of any (diagnostic or prognostic) prediction rule tends to be lower than expected based on the original study results. therefore, rules need to be tested on their generalizability. the aim was to determine the generalizability of the rule. in this cross-sectional study, primary care patients with suspicion of dvt were prospectively identified. the rule items were obtained from each patient plus ultrasonography as reference standard. the accuracy of the rule was quantified on its discriminative performance, sensitivity, specificity, negative predictive value, and negative likelihood ratio, with accompanying % confidence interval. dvt could be safely excluded in % ( % in the original study) of the patients, without referral. none of these patients had dvt ( . % in the derivation population). in conclusion, the rule appears to be a safe diagnostic tool for excluding dvt in patients suspected of dvt in primary care. abstract background: long-term exposure to very low concentrations of asbestos in the environment and relation to incidence of mesothelioma contributes to insight into the dose-response relationship and public health policy. aim: to describe regional differences in the occurrence mesothelioma in the netherlands in relation to the occurrence in the asbestos polluted area around goor and to determine whether the increased incidence of pleural mesothelioma among women in this area could be attributed to environmental exposure to asbestos. methods: mesothelioma cases were selected in the period - from the netherlands cancer register (n = ). for the women in the region goor (n = ) exposure to asbestos due to occupation, household or environment was verified from the medical files, the general practitioner and next-of-kin for cases. results: in goor the incidence of pleural mesothelioma among women was -fold increased compared with the netherlands and among men fold. of the additional cases among women, cases were attributed to the environmental asbestos pollution and in cases this was the most likely cause. the average cumulative asbestos exposure was estimated at . fiber-years. . temporal trends and gender differences were investigated by random slope analysis. variance was expressed using median odds ratio (mor). results: ohcs appeared to be more relevant than administrative areas for understanding physicians' propensity to follow prescription guidelines (mor_ohc = . and mor_aa = . ). conclusion and discussion: as expected, the intervention increased prevalence and decreased variance, but at the end of the observation period practice variation remained high. these results may reflect inefficient therapeutic traditions, and suggest that more intensive interventions may be necessary to promote rational statin prescription. abstract background: mortality rates in ska˚ne, sweden have decreased in recent years. if this decline has been similar for different geographical areas have not been examined closely. objectives: we wanted to illustrate trends and geographical inequities in all cause mortality between the municipalities in ska˚ne, sweden from to . we also aimed to explore the application of multilevel regression analysis (mlra) in our study, since it is a relatively new methodology when describing mortality rates. design and methods: we used linear mlra with years at the first level and municipalities at the second to model direct age-standardized rates. temporal trends were examined by random slope analysis. variance across time was expressed using intra-class correlation (icc). results: the municipality level was very relevant for understanding temporal differences in mortality rates (icc = %). in average, mortality decreased by / Ù along the study period but this trend varied considerably between municipalities, geographical inequalities along the years were u-shaped with lowest variance in the s (var = ). conclusion: mortality has decreased in ska˚ne but municipality differences are increasing again. mlra is a useful technique for modelling mortality trends and variation among geographical areas. abstract background: ozone has adverse health effects but it is not clear who is most susceptible. objective: identification of individuals with increased ozone susceptibility. methods: daily visits for lower respiratory symptoms (lrs) in general practitioner (gp) offices in the north of the netherlands ( - , patients) were related to daily ozone levels in summer. ozone effects were estimated for patients with asthma, copd, atopic dermatitis, and cardiovascular diseases (cvd) and compared to effects in patients without these diseases. generalized additive models adjusting for trend, weekday, temperature, and pollen counts were used. results: the mean daily number of lrs-visits in summer in the gp-offices varied from . to . . mean (sd) -hour maximum ozone level was . ( . ) lg/m . rrs ( % ci) for a lg/m increase (from th to th percentile) in the mean of lag to of ozone for patients with/ without disease are: abstract asthma is a costly health condition, its economic effect is greater than that estimated for aids and tuberculosis together. following global initiative for asthma recommendations that require more data about the burden of asthma, we have determined the cost of this illness from - . an epidemiological approach based on population studies was made to estimate global as well as direct and indirect costs. data were obtained mainly from the national health ministry database, the national statistics institute of spain and the national health survey. the costs were averaged and adjusted to e. we have found a global burden (including private medicine) of million e. indirect and direct costs account for , and , %.the largest components within direct costs were pharmaceutical ( . %), primary health care systems ( , %), hospital admissions ( . %) and hospital non-emergency ambulatory visits ( . %). within indirect costs, total cessation of work days ( . %), permanent labour incapacity ( . %) and early mortality ( . %) costs were the main components. pharmaceutical cost is the first component as in most studies from developed countries, followed by primary health care systems unlike some reports that consider hospital admissions in second place. finally, direct costs represent . % of the total health care expenditure. abstract background: it is well known that fair phenotypical characteristics are a risk factor for cutaneous melanoma. the aim of our study was to investigate the analogous associations between phenotypical characteristics and uveal melanoma. design/methods: in our casecontrol study we compared incident uveal melamom patients with population controls to evaluate the role of phenotypical characteristics like iris-, hair-and skin color and other risk factors in the pathogenesis of this tumor. a total of patients and controls matched on sex, age and region were interviewed. conditional logistic regression was used to calculate odds ratio (or) and % confidence intervals ( % ci). results: risk of uveal melanoma was increased among people with light iris color (or = . % ci . - . ) and light skin color was slightly associated with an increased risk of uveal melanoma (or . % . - . ). hair color, tanning ability, burning tendency and freckles as a child showed no increased risk. results of the combined analysis of eye-and hair color, burning tendency and freckles showed that only light iris color was clearly associated with uveal melanoma risk. conclusion: among potential phenotypical risk factors only light iris-and skin color were identified as risk factor for uveal melanoma. abstract background: between-study variation in estimates of the risk of hcv mother-to-child transmission (mtct) and associated risk factors may be due to methodological differences or changes in population characteristics over time. objective: to investigate the effect of sample size and time on risk factors for mtct of hcv. design and methods: heterogeneity was assessed before pooling data. logistic regression estimated odds ratios for risk factors. results: the three studies included mother-child pairs born between and , born between and , and between and . there was no evidence of heterogeneity of the estimates for maternal hcv/hiv co-infection and mode of delivery (q = . , p = . and q = . , p = . , respectively). in pooled analysis the proportion of hcv/hiv co-infected mothers significantly decreased from % before to % since (p< . ). the pooled adjusted odds ratios for maternal hcv/hiv co-infection and elective caesarean section delivery were . ( %ci . - . ), p< . and . ( %ci . - . ), p = . respectively. there was no evidence that the effect of risk factors for mtct changed over time. conclusion: although certain risk factors have become less common, their effect on mtct of hcv has not changed substantially over time. abstract background: the need to gain insight into prevailing eating pattrerns and their health effects is evident. objective: to identify dietary patterns and their relationship with total mortality in dutch older women. methods: principal components analysis on food groups was used to identify dietary patterns among , women ( - y) included in the dutch epic-elderly cohort (follow-up $ . y). mortality ratios for three major principle components were assessed using cox proportional hazard analysis. results: the most relevant principal components were a 'mediterranean-like' pattern (high in vegetable oils, pasta/rice, sauces, fish, and wine), a 'traditional dutch dinner' pattern (high in meat, potatoes, vegetables, and alcoholic beverages) and a 'healthy traditional' pattern (high in vegetables, fruit, non-alcoholic drinks, dairy products, and potatoes). in , person years deaths occurred. independent of age, education, and other life style factors only the 'healthy traditional' pattern score was associated with a lower mortality rate, women in the highest tertile experienced a percent reduced mortality risk. conclusion: from this study a healthy traditional dutch diet, rather than a mediterranean diet, appears beneficial for longevity and feasible for health promotion. this diet is comparable to other reported 'healthy' or 'prudent' diets that have been shown to be protective. parents of (aged - ) and (aged - ) children were sent a questionnaire, as were adolescents (aged - ). to assess validity, generic outcome instruments were included (infant toddler quality of life questionnaire (itqol) or the child health questionnaire (chq) and the euroqol- d). response rate was - %. internal consistency of hobq and boq-scales was good (cronbach's alpha's > . in all but two scales). test-retest results showed no differences in - % of scales. high correlations between hobq-and boq-scales and conceptually equivalent generic outcome instruments were found. the majority of hobq ( / ) and boq scales ( / ) showed significant differences between children with a long versus short length of stay. the dutch hobq and boq can be used to evaluate functional outcome after burns in children. the study estimated caesarean section rates and odds ratios for caesarean section in association with maternal characteristics in both public and private sectors; and maternal mortality associated with mode of delivery in the public sector, adjusted for hypertension, other disorders, problems and complications, as well as maternal age. results: the caesarean section rate was . % in the public sector, and . % in the private sector. the odd ratio for caesarean section was . ( %ci: . - . ) for women with or more years of education. the odd ratio for maternal mortality associated with caesarean section in the public sector was . ( %ci: . - . ). conclusion and discussion: sao paulo presented high caesarean section rates. caesarean section compared to vaginal delivery in the public sector presented higher risk for mortality even when adjusted for hypertension, other disorders, problems and complications, as well as maternal age. we show that serious bias in questionnaires can be revealed by bland-altman methods but may remain undetected by correlation coefficients. we refute the argument that correlation coefficients properly investigate whether questionnaires rank subjects sufficiently well. conclusions: the commonly used correlation approach can yield misleading conclusions in validation studies. a more frequent and proper use of the bland-altman methods would be desirable to improve epidemiological data quality. abstract screening performance relies on quality and efficiency of protocols and guidelines for screening and follow-up. evidence of low attendance rates, over-screening of young women and low smear specificity gathered by the early 's in the dutch cervical cancer screening program called for an improvement. several protocols and guidelines were redefined in , with emphasis on assuring that these would be adhered to. we assessed improvement since by changes in various indicators: coverage rates, follow-up compliance and number of smears. information on all cervix uteri tests in the netherlands registered until st march was retrieved from the nationwide registry of histo-and cytopathology (palga). five-year coverage rate in the age group - years rose to %. the percentage of screened women in follow-up decreased from % to %. fourteen percent more women with abnormal smears were followed-up, and the time spent in follow-up decreased. a % decrease in the annual number of smears made was observed, especially among young women. in conclusion, the changes in protocols and guidelines, and their implementation have increased coverage and efficiency of screening, and decreased the screening-induced negative side effects. similar measures can be used to improve other mass screening programmes. abstract background: it is common knowledge that in low endemic countries the main transmission route of hepatitis b infection is sexual contact, while in high endemic regions it is perinatal transmission and horizontal household transmission in early childhood. objectives: to get insight into what determines the main transmission route in different regions. design and methods: we used a formula for the basic reproduction number r for hepatitis b in a population stratified by age and sexual activity to investigate under which conditions r > . using data extracted from the literature we investigated how r depends on fertility rates, rates of horizontal childhood transmission and sexual partner change rates. results: we identified conditions on the mean offspring number and the transmission probabilities for which perinatal and horizontal childhood transmission alone ensures that r > . those transmission routes are then dominant, because of the high probability for children to become chronic carriers. sexual transmission dominates if fertility is too low to be the driving force of transmission. conclusion: in regions with high fertility rates hepatitis b can establish itself on a high level of prevalence driven by perinatal and horizontal childhood transmission. therefore, demographic changes can influence hepatitis b transmission routes. abstract background: the artificial oestrogen diethylstilboestrol is known to be fetotoxic. thus, intrauterine exposure to other artificial sex hormones may increase the risk of fetal death. objective: to study if use of oral contraceptive months prior to or during pregnancy is associated to an increased risk of fetal death. design and methods: a cohort study of pregnant women who were recruited into the danish national birth cohort during the years - and interviewed about exposures during pregnancy, either during the first part of their pregnancy (n = ) or following a fetal loss (n = ). cox regression analyses with delayed entry were used to estimate the risk of fetal death. results: in total ( . %) women took oral contraceptives during pregnancy. use of combined oestrogen and progesterone oral contraceptives (coc) or progesterone only oral contraceptives (poc) during pregnancy were not associated with increased hazard ratios of fetal death compared to non-users, hr . ( % ci . - . ) and hr . ( % ci . - . ) respectively. neither use of coc nor poc prior to pregnancy was associated with fetal death. conclusion: use of oral contraceptive months prior to conception or during pregnancy is not related to an increased risk of fetal death. abstract background: few studies have been performed to assess if water fluoridation reduces social inequalities among groups of different socioeconomic status, and none of them was conducted in developing countries. objectives: to assess socioeconomic differences between brazilians towns with and without water fluoridation, and to compare dental caries indices among socioeconomic strata in fluoridated and non-fluoridated areas. design and methods: a countrywide survey of oral health performed in - and comprising , children aged years provided information about dental caries indices in brazilian towns. socioeconomic indices, the coverage and the fluoride status of the water supply network of participating towns were also appraised. multivariate regression models were performed. inequalities in dental outcomes were compared in towns with and without fluoridated tap water. results: better-off towns tended to present a higher coverage by the water supply network, and were more inclined to add fluoride. fluoridated tap water was associated with an overall improved profile of caries, concurrent with an expressively larger inequality in the distribution of dental disease. conclusion: suppressing inequalities in the distribution of dental caries requires an expanded access to fluoridated tap water; a strategy that can be effective to foster further reductions in caries indices. objective: to investigate the role of family socioeconomic trajectories from childhood to adolescence on dental caries and associated behavioural factors. design and methods: a population-based birth cohort was carried out in pelotas, brazil. a sample (n= ) of the population of subjects born in were dentally examined and interviewed at aged . dental caries index, care index, toothbrushing, flossing, and pattern of utilization of dental services were the outcomes. these measures were compared among four different family income trajectories. results: adolescents who were always poor showed, in general, a worse dental caries profile, whilst adolescents who never were poor had a better dental caries profile. adolescents who had moved from poverty in childhood to nonpoverty in adolescence and those who had moved from non-poverty in childhood to poverty in adolescence had similar dental profiles to those who were always poor except for pattern of utilization of dental services which was higher in the first group. conclusion: poverty in at least one stage of the lifespan has a harmful effect on dental caries, oral behaviours and utilization of dental services. we assessed contextual and individual determinants of dental caries in the brazilian context. a country-wide survey of oral health informed the dental status of , twelve-year-old schoolchildren living in towns in . a multilevel model fitted the adjustment of untreated caries prevalence to individual (socio-demographic characteristics of examined children) and contextual (geographic characteristics of participating towns) covariates. being black (or = . ; % ci: . - . ), living in rural areas (or = . ; . - . ) and studying in public schools (or = . ; . - . ) increased the odds of having untreated decayed teeth. the multilevel model identified the fluoride status of water supplies (ß=) . ), the proportion of households linked to the water network (ß=) . ) and the human development index (ß=) . ) as town-level covariates of caries experience. better-off brazilian regions presented an improved profile of dental health, besides having a less unequal distribution of dental treatment needs between blacks and whites, rural and urban areas, and public and private schools. dental caries experience is prone to socio-demographic and geographic inequalities. monitoring contrasts in dental health outcomes is relevant for programming socially appropriate interventions aimed both at overall improvements and at the targeting of resources for groups of population presenting higher levels of needs. abstract background: ultraviolet radiation (uvr) is the main cause of nonmelanoma skin cancer but has been hypothesised to protect against development of prostate cancer (pc). if this is true, skin cancer patients should have lower pc incidence than the general population. objectives: to study the incidence of pc after a diagnosis of skin cancer. design methods: using the eindhoven cancer registry, a cohort of male skin cancer patients diagnosed since ( squamous cell carcinoma (scc), basal cell carcinoma (bcc) and melanoma (cm)) was followed up for incidence of invasive pc. observed incidence rates of pc amongst skin cancer patients were compared to those in the reference population, resulting in standardised incidence ratios (sir). results: scc (sir . ( %ci: . ; . )) and bcc (sir . ( %ci: . ; . )) showed a decreased incidence of pc, cm did not. patients with bccs occurring in the chronically sun-exposed head and neck area (sir . ( %ci: . ; . ) had significantly lower pc incidence rates. conclusion discussion: although numbers of scc and cm were too small to obtain unequivocal results, this study partly supports the hypothesis that uvr protects against pc and also illustrate that cm patients are different from nmsc patients in several aspects. abstract introduction: hypo-and hyperthyroidism have been associated to various symptoms and metabolic dysfunctions in men and women. incidences of these diseases have been estimated in a cohort of middle-aged adults in france. methods: the su.vi.max (sup-ple´mentation en vitamines et mine´raux antioxydants) cohort study included volunteers followed-up for eight years since - . the incidence of hypo-and hyperthyroidism was estimated retrospectively from scheduled questionnaires and the data transmitted by the subjects during their follow-up. factors associated to incident cases have been identified by cox proportional hazards models. results: among the subjects free of thyroid dysfunction at inclusion, incident cases were identified. after an average follow-up of . years, the incidence of hyper-and hypothyroidism was . % in men, . % in - year old women, and . % in - year old women. no associated factor was identified in men. in women, age and alcohol consumption (> grams/day) increased the risk of hypo-or hyperthyroidism, while a high urinary thiocyanate level in - would be a protective factor. conclusion: the incidences of hypo and hyperthyroidism observed in our study as well as the associated risk factors found are in agreement with the data of studies performed in other countries. abstract background: lung cancer is the most frequent malignant neoplasm world-wide. in , the number of new lung cancer cases was estimated at . million, which makes over % of all new cases of neoplasm registered all round the globe. it is also the leading cause of cancer deaths. objective: the objective of this paper is to provide a systematic review of life-related factors for lung cancer risk. methods: data sources were medline from january to december , title in the field. search terms included: lung cancer, tobacco smoke, education, diet, alcohol consumption or physical activity terms. book chapters, monographs, relevant news reports, and web material were also reviewed to find articles. results: the results of the literature review suggest that smoking is a major, unquestionable factor of lung cancer risk. exposure to environmental tobacco smoke (ets) and education could also play a role in the occurrence of the disease. diet, alcohol consumption and physical activity level are other important but less extended determinants of lung cancer. conclusions: effective prevention programs against some of the life style-related factors for lung cancer, especially against smoking must be developed to minimize potential health risks and prevent the future cost of health. stedendriehoek twente and south (n = ), additional data (co-morbidity, complications after surgery and follow-up) were gathered. cox-regression analyses were used. results: the proportion resections declined from % of patients < to % of patients aged > = years, whereas primary radiotherapy increased from % to %. in the two regions patients ( %) underwent resection. co-morbid conditions did not influence the choice of the therapy. % had complications. postoperative mortality was %. in multivariate analysis, only treatment had an independent effect.two year survival was % for patients undergoing surgical resection and % for those receiving radiotherapy (p< . ). conclusion: number of co-morbid conditions did not influence choice of treatment, postoperative complications, and survival in patients with nsclc > = years. the epidemiology of oesophageal cancer has changed in recent decades. the incidence has increased sharply, mainly comprising men, adenocarcinoma and tumours of the lower third of the oesophagus. the eurocare study suggested large variation in survival between european countries, primarily related to early mortality. to study potential explanations, we compared data from the rotterdam and thames cancer registry. computer records from , patients diagnosed with oesophageal cancer in the period - were analysed by age, gender, histological type, tumour subsite, period and region. there was a large variation in resection rates between the two regions, % for rotterdam versus % for thames (p< . ). resection rates were higher for men, younger patients, adenocarcinoma and distal tumours. postoperative mortality (pom) was defined as death within days of surgery and was . % on average. pom increased with age from . % for patients younger than years to . % for patients older than years. pom was significantly lower in high-volume hospitals (> operations per year), . % versus . % (p< . ). this study shows a large variation in treatment practice between the netherlands and the united kingdom. potential explanations will need to be studied in detail. abstract russia has experienced tremendous decline in life expectancy after break up of the ussr. surprisingly, im has also been decreasing. less is known on the structure of im in different regions of russia. the official im data may be underestimated partly due to misreporting early neonatal deaths (end) as stillbirths (sb). end/sb ratio considerably exceeding : indicates misreporting. we present the trends and structure of im in arkhangelsk oblast (ao), north-west russia from to as obtained from the regional statistical committee. im decreased from . to . per live births. cause-specific death rates (per , ) decreased from to . for infectious diseases, from to for respiratory causes, from to for traumas, from to for inborn abnormalities but did not change for conditions of the perinatal period ( in both and ) . the end/sb ratio increased from to . . in , im from infections and respiratory causes in the ao are much lower than in russia in general. the degree of misreporting end as sb in the ao is lower than in russia in general. other potential sources of underestimation of im in russia will be discussed. abstract background: epidemiological studies that investigated malocclusion and different physical aspects in adolescents are rare in the literature. objective: we studied the impact of malocclusion on adolescents' self-image regardless of other physical aspects. design and methods: a cross-sectional study nested in a cohort study was carried out, in pelotas, brazil. a random sample of yearsold adolescents was selected. the world health organization ( ) criteria were used to define malocclusion. interviews about self-reported skin colour and appearance satisfaction were administered. the body mass index was calculated. gender, birth weight and socioeconomic characteristics were obtained from the birth phase of the cohort study. poisson regression models were performed. results: the prevalence of moderate or severe malocclusion was . % [ %ci . ; . ] in the whole sample without significant difference between boys and girls. a higher statistically significant difference of appearance dissatisfaction was identified in girls ( . %) than in boys ( . %). a positive association between malocclusion and appearance dissatisfaction was observed only in girls, after adjusting for other physical and socioeconomic characteristics. conclusions: malocclusion influenced appearance dissatisfaction only in young women. abstract background: factors for healthy aging with good functional capacity and those which increase the risk of death and disability need to be identified. objectives: we studied the prevalence of low functional capacity and its associations in a small city in southern brazil. design and methods: a population based cross sectional study was carried out with a random sample size of elderly people. a home-applied questionnaire including socioeconomic, demographic, house conditions, socioeconomic self-perception characteristics was applied. the low functional capacity was defined as the difficulty in the performance of or more activities or inability to carry out of those activities according to scale proposed by rikli and jones. descriptive statistics, association using chi-square test as well as the multiple logistic regression analysis were performed. abstract introduction: assessment of trichiuriasis spatial distribution is important to evaluate sanitation conditions. our objective was to identify risk areas for the trichuris trichiura infection. methods: cross sectional study was held in census tracts of duque de caxias county, rio de janeiro, brazil. collection and analysis of fecal specimens and a standardize questionnaire were carry out in order to evaluate socio-economic and sanitation conditions in a sample of , children between and years old. geoestatistics techniques were used to identify risk areas for trichiuriasis. results: the mean age of the studied population was . years old, which % were females and % were males. the prevalence of trichuris trichiura in the sample was %. children whose mothers studied for years or less had odds ratio (or) = . than children whose mothers studied for more than years old. children who were living in houses without water supply had or = . comparing to children living in houses with water supply. the spatial analysis identified risk areas for infection. conclusion: the results show association between socio-economic conditions and the proliferation of trichuris trichiura infection. the identification of risk areas can guide efficient actions to combat the disease. abstract background: refuge life and diabetes mellitus can affect the healthrelated quality of life (hrqol). objective: to assess how both aspects influence hrqol of the diabetic refugees in gaza strip. methods: overall subjects filled a self-administered questionnaire including world health organization quality of life questionnaire (whoqol-bref) and some socio-demographic information. the sample consisted of three frequency matched groups for gender and sex, each. first group were refugees with diabetes mellitus, second refugees without diabetes and third diabetes patients with no refugee history. the response rate was % on average. global score consisting of all four domains of who-qol-bref was dichotomized by the value of and logistic regression was used for the analysis. results: crude odds ratios (or) for lower quality of life were . ( % ci . - . ) for diabetes refugees compared to diabetes non-refugees and . ( . - . ) compared to non-diabetes refugees. after adjusting for age, gender, education, employment, income status and number of persons depending on the respondents or was . ( . - . ) and . ( . - . ), respectively. additionally, adjusting for length of diabetes and complications reduced the or to . ( . - . ) for diabetes refugees compared to diabetes non-refugees. conclusion: quality of life is highly reduced in refugees with diabetes. abstract background: pesticides have a significant public health benefit by increasing food production productivity and decreasing diseases. on the other hand, public concern has been raised about the potential health effects of the exposure to pesticides on the developing fetus and child. objectives: to review the available literature to find an epidemiological studies dealing with the exposure to pesticides and children health. design and methods: epidemiological studies were identified during search of the literature basis. following health effects were taking into account: adverse reproductive and developmental disorders, childhood cancer, neurodevelopmental effects and the role of pesticides as endocrine disrupters. results: pesticides were associated with wide range of reproductive disorders. the association between exposure to pesticides and the risk of childhood cancer and neurodevelopmental effects was found in several studies. epidemiological studies have been limited by luck of specific pesticide exposure, exposure based on job title, small size of examined groups. conclusions: in the light of existing although still limited evidence of adverse effects of pesticide exposure it is necessary to reduce the exposure. the literature review suggests a great need to increase awareness of people who are occupationally or environmentally exposed to pesticides about its potential negative influence on their children. in order to match local health policy more with the needs of citizens, the municipal health service utrecht started the project 'demand-orientated prevention policy'. one of the aims was to explore the needs of the utrecht citizens. the local health survey from contained questions about needs of information and support with regard to disorders and lifestyle. do these questions about needs give other results compared to questions about prevalence of health problems? in total utrecht citizens aged to years returned the health questionnaire (response rate %). most needs were observed on subjects concerning overweight and mental problems, and were higher among women, moroccans, turks, low educated people and citizens of deprived areas. the prevalence of disorders and unhealthy lifestyles did not correlate well to the needs (majority correlation coefficients: < , ). most striking, of the utrecht population % were smokers and % excessive alcohol drinkers, while needs related to these topics were low. furthermore, higher needs among specific groups did not always correspond to higher prevalences of related health problems in these groups. these results show the importance of including questions about needs in a health survey, because they add additional information to questions about prevalences. abstract background: recent studies associated statin therapy with better outcome in patients with pneumonia. because of an increased risk of pneumonia in patients with diabetes we aimed to assess the effects of statin use on pneumonia occurrence in diabetic patients managed in primary care. methods: we performed a case-control study nested in , patients with diabetes. cases were defined as patients with a diagnosis of pneumonia. for each case, up to controls were matched by age, gender, practice, and index date. patients were classified as current statin user when the index date was between the start and end date of statin therapy. results: statins were currently used in . % of , cases and in . % of , controls (crude or: . , % ci . - . ). after adjusting for potential confounders, statin therapy was associated with a % reduction in pneumonia risk (adjusted or: . , % ci . - . ). the association was consistent among relevant subgroups (stroke, heart failure, and pulmonary diseases) and independent of age or use of other prescription drugs. conclusions: use of statins was significantly associated with reduced pneumonia risk in diabetic patients and may apart from lipid lowering properties be useful in prevention of respiratory infections. abstract introduction: cigarette smoking is the most important risk factor for copd development. therefore, smoking cessation is the best preventive measure. aim: to determine the beneficial effect of smoking cessation on copd development. methods: incidence of copd (gold stage > = ) was studied in smokers without copd who quitted or continued smoking during yr of followup. we performed logistic regression analyses on pairs of observations. correlations within a subject and time, and time between successive surveys were taken into account. abstract objectives: to describe the prevalence and severity of dental caries in adolescents of the city of porto, portugal, and to assess socioeconomic and behavioral covariates of dental caries experience. methods: a sample of thirteen-year-old schoolchildren underwent dental examination. results from the dental examination were linked to anthropometric information and to data supplied by two structured questionnaires assessing nutritional factors, sociodemographic characteristics and behaviors related to health promotion. dental caries was appraised in terms of the dmft index, and two dichotomous outcomes, one assessing the prevalence of dental caries (dmft = ); the other assessing the prevalence of a high level of dental caries (dmft = ). results: consuming soft drinks derived from cola two or more times per week, attending a public school, being girl and having parents with low educational attainment were identified as risk factors both for having dental caries and for having a high level of dental caries. conclusion: the improvement of oral health status in the portuguese context demands the implementation of polices to reduce the frequency of sugar intake, and could benefit from an overall and longstanding expansion of education in society. abstract background: migrant mortality does not conform to a single pattern of convergence towards rates in the host population. to better understand how migrant mortality will develop, there is a need to further investigate how the underlying behavioural determinants change following migration. objective: we studied whether behavioural risk factors among two generations of migrants converge towards the behaviour in the host population. design and methods: cross-sectional interview-data were used including moroccan and turkish migrants, aged - . questions were asked about smoking, alcohol consumption, physical inactivity and weight/height. age-adjusted prevalence rates among first and second generation migrants were compared with prevalence rates in the host population. results: converging trends were found for smoking, physical inactivity and overweight. for example, we found a higher prevalence of physical inactivity in first generation turkish women as compared to ethnic dutch (or = . ( . - . )), whereas among second generation no differences were found (or = . ( . - . )). however, this trend was not found in all subgroups. additionally, alcohol consumption remained low in all subgroups and did not converge. conclusion and discussion: behavioural risk factors in two generations of migrants seem to converge towards the prevalence rates in the host population. although, some groups and risk factors showed a deviant pattern. abstract background/relevance: arm-neck-shoulder complaints are common in general practice. for referral in these complaints, only guidelines exist for shoulder complaints and epicondylitis. besides, other factors can be important. objective: what factors are associated with referral to physiotherapy or specialist in non-traumatic armneck-shoulder complaints in general practice, during the first consultation? design/methods: general practitioners (gps) recruited consulters with new arm, neck or shoulder complaints. data on complaint-, patient-, gp-characteristics and management were collected. the diagnosis was categorised into: shoulder specific, epicondylitis, other specific or non-specific. multilevel analyses (adjustment for treating gp) were executed in procgenmod to assess associated variables (p< . ). results: during the first consultation, % was referred for physiotherapy and % for specialist care. indicators of reference to physiotherapy were: long duration of complaint, recurrent complaint and gp located in a little/not urbanised area. while having shoulder specific or other specific diagnoses was negatively associated. indicators of reference to specialist care were: having other specific diagnosis, long duration of complaint, musculoskeletal co-morbidity, functional limitations and consulting a less experienced gp. conclusion/discussion: most referrals were to physiotherapy and only a minority to specialist care. mainly diagnosis and other complaint variables indicate on 'who goes where'. besides gp-characteristics can play a role. abstract background: the ruhr area has for years been a synonym for a me´gapolis of heavy industry with a high population density. presently, % of the population of the state of north rhine-westphalia live there, i.e. more than five million people. objectives: for the first time, social and health indicators of nrw's health indicator set were brought together for this me´gapolis area. design and methods: new standard tables were constructed for the central area of 'ruhr-city' including seven cities with more than inhabitants/km and the peripheral zone with eight districts and cities. for the pilot phase, four socio-demographic and four health indicators were recalculated. comparability of the figures was achieved by age standardization. the results obtained were submitted to a significance test by identifying % confidence intervals. results: the centre of 'ruhr-city' is characterised by elderly, unemployed, foreign, low-income citizens living closely together. infant mortality lies above nrw's average, male life expectancy is . years lower and female life expectancy . years lower than life expectancy in nrw (without 'ruhr-city'). several avoidable deaths' rate in the ruhr area are significantly higher than the average in nrw. specific intervention strategies are required to improve the health status in 'ruhr-city'. abstract background: general practitioners (gps) have a fundamental role to play in tobacco control, since they reach a high percentage of the target population. objectives: to evaluate specific strategies to enhance promotion of smoking cessation in general practice. design and methods in a cluster-randomized trial, medical practices were randomized following a · factorial design. patients aged - years who smoked at least cigarettes per day (irrespective of their intention to stop smoking) were recruited. the intervention included (ti) the provision of a two-hour physician group training in smoking cessation methods plus direct physician payments for every participant not smoking months after recruitment; and (tm) provision of the same training plus direct participant reimbursements for pharmacy costs associated with nicotine replacement therapy or bupropion treatment. results: in the mixed logistic regression model, no effect was identified for intervention ti (odds ratio (or) = . , % confidence interval (ci) . - . ), but intervention tm strongly increased the odds of cessation (or = . , % ci . - . ). conclusion and discussion: the cost-free provision of effective medication along with improved training opportunities for gps may be an effective measure to enhance smoking cessation promotion in general practice. in europe, little research on international comparison of health surveys has been accomplished, despite a growing interest in this field. smoking prevalence is chosen to explore data comparability. we aim to illustrate methodological problems encountered when comparing data from health surveys and investigate international variations in smoking behaviour. we examined a sample . individuals aged and more, from six european health surveys performed in - . problems met during the comparisons are described. we took the example of current smoking as an indicator allowing a valid comparison of the prevalences. the differences in age and sex distribution between countries were adjusted through direct standardisation. additionally, multivariate analysis will assess variations in current smoking between countries, when controlling for sex, age, and educational level. methodological problems concern comparability of socioeconomic variables. the percentage of current smokers varies from % to %. smoking patterns observed by age groups, sexes and educational level are similar, although rates per country differ. further results will determine if the variations in smoking related to socioeconomic status are alike. this international comparison of health surveys highlights methodological problems encountered when comparing data of several countries. furthermore, variations in smoking may call for adaptations in public health programs. from research it appears that adolescent alcohol use in the achterhoek is much higher than in the rest of the netherlands and rapidly increasing. excessive alcohol use has consequences for health and society. parents play an important role in preventing excessive adolescent alcohol use, but are not aware of the problem and consequences. for this reasons the municipalities in the achterhoek launch an alcohol moderation programme, starting with a regional media campaign to increase problem awareness among parents. the objective of this study is to assess the impact of this media campaign in the achterhoek. three successive independent cross-sectional telephone surveys, interviewing approximately respondents each, will be conducted before, during and after the campaign. respondents will be questioned on knowledge and awareness of excessive adolescent alcohol use, its consequences and the role child raising can play. also the reach and appreciation of the different activities of the campaign will be investigated. results: of the surveys before and during the implementation will be known by may . with these first findings the unawareness of the problem among parents and partly the reach and appreciation of the campaign can be assessed. abstract background: obesity is a growing problem, increasingly so in children and adolescents. overweight is partly 'programmed' during pregnancy, but few comprehensive studies looked prospectively into the changes of body composition and metabolic factors from birth. objectives: the aim of the population-based birth-cohort study within gecko is to study the etiology and prognosis of overweight and the metabolic syndrome during childhood. design and methods: the gecko drenthe will be a population based observational birth-cohort study, which includes all children born from april to april in drenthe, one of the northern provinces of the netherlands. during the first year of life, the study includes repeated questionnaires, extensive anthropometric measurements and blood measurements at birth (cord blood) and at the age of eleven months. results: the number of babies born in the drenthe province is about . per year. the results from a feasibility study conducted in february will be presented. conclusion: gecko drenthe is a unique project that will contribute to the understanding of the development of obesity in childhood and its tracking into adulthood. this will enable early identification of children at risk and opens the way for timely and tailored preventive interventions. abstract background: tunisia is facing an epidemiologic transition with the extension of chronic diseases that share common risk factors. obesity is a leading risk factor and happens to occur frequently in early life. objective: to study the prevalence and the risk factors of obesity and overweight among urban schoolchildren in sousse, tunisia. methods: cross sectional study of a tunisian sample of schoolchildren aged between and years living in the urban area of sousse, tunisia. a representative sample of school children selected by multistage cluster sampling procedure. measurements: weight and height, blood pressure measured by electronic system, fasting blood lipids. questionnaire assessment was used for family history of cardiovascular disease, smoking habits, physical activity and diet. abstract background: quality of life (qol) measurements are acknowledged as very important in the evaluation of health care. objectives: we studied the validity and the reliability of the hungarian version of the whoqol-bref among people living in small settlements. method: a questionnaire-based cross-sectional study was conducted in a representative sample (n = ) of persons aged years and over in south-east-hungary, in . data were analysed by the spss . . the internal consistency was evaluated using cronbach's alpha; for comparison of the qol scores amongst the various groups the two-tailed t-tests were used; convergent validity was assessed by spearman coefficients. results: the male:female ratio was . to . %, and the average age . (sd: . ) years. the domain scores were . (sd: . ) for the physical, . (sd: . ) for psychological, . (sd: . ) for the social, and . (sd: . ) for the environment domains. the cronbach's alpha values ranged from . to . across domains. the whoqol-bref seemed to be suitable to distinguish healthy and unhealthy people. the scores for all domains correlated with the self-evaluated health, and overall quality of life (p< . ). conclusion: our study supported that the whoqol-bref provided a valid, reasonable and useful determination of the qol of people living in hungarian villages. abstract background: further than a cardiovascular disease, arterial hypertension (aht) is the main cardiovascular risk factor. in spain, the aht prevalence reaches %, placed in the third position after germany and finland in affecters percentage. although its high morbi-mortality, the aht is a forecast factor. the treatment's objective (pharmacological and life style modifications) of hypertensive patients is not only to reduce blood pressure levels to optimum levels but also to treat all modifiable vascular risk factors. objective: economic impact evaluation of direct costs due to aht pathology (cie -mc - ) in spain in , according to autonomous region. design and methods: descriptive and transversal study of costs estimation in the period between january to december in spain according to autonomous region. the study is based on data available from the national health ministry database and the national statistics institute of spain. results: the national health service assigned million e to aht treatment. , % of the total cost is owe to pharmaceutical service expenses, , % to primary health care and a , % to hospital admissions. conclusion and discussion: the costs generated by aht are mainly due to the pharmaceutical service. the costs distribution is modified according to the geographical region. abstract background: over the last decades, for low-stage cervical cancer less surgical treatment and for high-stage cervical cancer chemoradiotherapy was recommended in the national guidelines. objectives: to describe changes and variation in treatment and survival in cervical cancer in the regions of the comprehensive cancer centre stedendriehoek twente (cccst) and south (cccs) in the netherlands. design and methods. newly diagnosed cervical cancer cases were selected from both cancer registries in the period - . patient characteristics, tumour characteristics, treatment and follow-up data were collected from the medical records. results: in figo stages ia -ib the percentage hysterectomy decreased from % in - to % in - (p<. ) and survival improved comparing - with - . figo stages iii-ivb had mostly received radiotherapy only ( %). no differences in survival between years of diagnosis were found. in the cccs-region more chemoradiotherapy was given in these stages ( % versus % in the cccst-region in the whole period). conclusion and discussion:. abstract background: the reason for the increased prevalence of depression in type diabetes (dm ) is unknown. objective: we investigated whether depression is associated with metabolic dysregulation or that depression is rather a consequence of having dm . methods: baseline data of the utrecht health project were used. subjects with cardiovascular disease were excluded. , subjects (age: . +/) ) were classified into four mutually exclusive categories: normal fasting plasma glucose (fpg < . mmol/l), impaired fpg (> = . and < . mmol/l), undiagnosed dm (fpg > = . mmol/l), and diagnosed dm . depression was defined as either a score of or more on the depression subscale of the symptom check list- or use of antidepressants. results: subjects with impaired fasting glucose and undiagnosed dm had no increased prevalence of depression. diagnosed dm patients had an increased prevalence of depression (or = . ( . - . )) after adjustment for gender, age, body mass index, smoking, alcohol consumption, physical activity, education level and number of chronic diseases. conclusions: our findings suggest that depression is not related to disturbed glucose homeostasis. the increased risk of depression in diagnosed dm only, suggests that depression is rather a consequence of the psychosocial burden of diabetes. abstract background: breast-conserving surgery (bcs) followed by radiotherapy (bcs-rt) is a safe treatment option for the large majority of patients with tumours less than cm. aim: the use of bcs and bcs-rt in pt (? cm) and pt -tumours ( - cm) was investigated in the netherlands in the period and . methods: from the netherlands cancer registry patients were selected with invasive pt (? . cm) or pt ( . - . cm) tumours, without metastasis at time of diagnosis. trends in the use of bcs and rt after bcs were determined for different age groups and regions. results: in the period - , pt -tumours and , pt -tumours were diagnosed. the %bcs in pt -tumours increased in all age groups. it remained lowest in patients years and older ( % in ). in pt -tumours a decrease was observed in patients years and older (from % to % in ). in both pt and pt tumours the %bcs-rt increased in patients years and older to respectively % and %. between regions and hospitals large differences were seen in %bcs and %bcs-rt. conclusion: multidisciplinary treatment planning, based on specific guidelines, and patient education could increase the use of bcs combined with rt in all age groups. abstract this is a follow-up study on the adverse health effects associated with pesticide exposure among cut-flower farmers. survey questionnaires and detailed physical and laboratory examinations were administered to and respondents, respectively, to determine pesticide exposure, work and safety practices, and cholinesterase levels. results showed that pesticide application was the most frequent activity associated with pesticide exposure, and entry was mostly ocular and dermal. majority of those exposed were symptomatic. on physical examination, or . % of those examined were found to have abnormal peak expiratory flow rate (pefr). eighty-two percent had abnormal temperature, followed by abnormal general survey findings (e.g. cardiorespiratory distress). % had cholinesterase levels below the mean value of . ? ph/hour, and . % exhibited a more than % depression in the level of rbc cholinesterase. certain hematological parameters were also abnormal, namely hemoglobin, hematocrit, and eosinophil count. using pearson's r, factors strongly associated with illness due to pesticides include using a contaminated piece of fabric to wipe sweat off (p.= . ) and reusing pesticide containers to store water (p.= . ). the greatest adverse effect of those exposed is an abnormal cholinesterase level which confirms earlier studies on the effect of pesticides on the body. objectives: this pair-study was performed to find out the rate of spontaneous abortions in female workers exposed to organic solvents from the wood-processing industry. methods: the level of organic solvents was assessed within the workplaces during a year period. exposed female workers from the wood-processing industry were examined. the occupational and non-occupational data associated with their fertility were obtained by applying a standard epidemiological computed questionnaire. the reference group consisted of female workers non-exposed to hypo-fertilizing agents, residing in the same locality. the rate of spontaneous abortions was evaluated in both groups as an epidemiological fertility indicator. results: within the studied period, the organic solvents levels exceeded several time the maximal admissible concentrations in all workplaces. the long-term exposure to organic solvents caused a significant increase in rate of spontaneous abortions compared to the reference group (p< . ). the majority of abortions ( %) have happened in the first trimester of pregnancy. conclusions: the long-term exposure to organic solvents may cause low fertility on female workers because of the spontaneous abortions. it is advised to reduce the organic solvents level in the air of all workplaces, as well as to stop working the pregnant women in exposure to organic solvents. abstract introduction: rio de janeiro city (rj) presents a fast aging of the population with changes in morbi-mortality. cardiovascular diseases are the first cause of death in elderly population. more than a half of ischemic heart diseases (ihd) cases occur in aged people (> years old). objective: describe the spatial distribution of ihd mortality in the elderly population in rj and associations with socio-demographics variables. methods: data were gathered from information on mortality system of the ministry of health and the demographic census of the foundation of the brazilian institute for geography and statistics. the geographic distributions of the standardized coefficient of mortality due to ihd and socio-demographics variables, by districts, in were analyzed in arcgis . . spatial autocorrelation of ihd was assessed by the moran and geary indices. a conditional autoregressive model was used to evaluate the association between idh and socio-demographics variables. results: association between idh mortality and income, educational level, family type and to possess computer, videocassette and microwave was found. conclusion: spatial analysis of the idh mortality and socio-demographics factors influence are fundamental to subsidize more efficient public policies in sense to prevention and control of this important injury of health. abstract purpose: to evaluate the prognostic impact of isolated loco-regional recurrences on metastatic progression among women treated for invasive stage i or ii breast cancer (within phase iii trials concerning the optimal management of breast cancer). patients and methods: the study population consisted of , women primary surgically treated for early stage breast cancer, enrolled in eortc trials , , or , by breast conservation ( %) and mastectomy ( %) with long time of follow-up (median: . range: . - . ). data were analysed in a multi-state model by using multivariate cox regression models, including a state-dependent covariate. results: after the incidence of the loco-regional recurrence, a positive nodal status at baseline is a significant prognostic risk factor for distant metastases. the effects of the young ages at diagnosis and larger tumour size, become less significant after the incidence of loco-regional recurrences. the presence of a locoregional recurrence in itself is a significant prognostic risk factor for distant metastases after loco-regional recurrences. the effect of the time to the loco-regional recurrence is not a significant prognostic factor. conclusion: the presence of local recurrence is an important risk factor for outcome in patients with early breast cancer. abstract background: the relationship between the antral follicles and ovarian reserve tests (ort) to determine ovarian response in ivf is extensively studied. we studied the role of follicle size distribution in the response on the various orts in a large group of subfertile patients. methods: in a prospective cohort study, female patients were included if they had regular ovulatory cycles, subfertility for > months, > = ovary and > = patent ovarian tube. antral follicles were counted by ultrasound and blood was collected for fsh, including a clomiphene challenge test (ccct), inhibin b, and estradiol before and after administration of puregon [rsymbol] . (efort test). statistical analysis was performed using spss . for windows. results: of eligible patients, participated. mean age was . years and mean duration of subfertility was . months. age, baseline fsh, ccct and efort correlated with the number of small follicles ( - mm) but not with large follicles ( - mm). regression analysis confirmed that the number of small follicles and average follicle size contributed to ovarian response after correction for age, while large follicles did not. conclusion: small antral follicles are responsible for the hormonal response in ort and may be suitable to predict ovarian response in ivf. abstract background: dengue epidemics account annually for several million cases and deaths worldwide. the high endemic level of dengue fever and its hemorrhagic form (dhf) correlates to extensive house infestation by aedes aegypti and multiple viral serotype human infection. objective: to describe dengue incidence evolutionary patterns and spatial distribution in brazil. methods: it is a review study that analyzed serial case reports registered since until . results: it was shown that defined epidemic waves followed the introduction of every serotype (den to ) , and reduction in susceptible people possibly responded for downward case frequency. conclusions and discussion: an incremental expansion of affected areas and increasing occurrence of dhf with high lethality were noted in recent years. in contrast, efforts based solely on chemical vectorial combat have been insufficient. moreover, some evidence demonstrated that educational action do not permanently modify population habits. in this regard it was stated that while vaccine is not available, further dengue control would depend on potential results gathered from basic interdisciplinary research and intervention evaluation studies, integrating environmental changes, community participation and education, epidemiological and virological surveillance, and strategic technological innovations aimed to stop transmission. abstract background: patient participation in treatment decisions can have positive effects on patient satisfaction, compliance and health outcomes. objectives: study objectives were to examine attitudes regarding participation in decision-making among psoriasis patients and to evaluate the effect of a decision-aid for discussing treatment options. methods: a 'quasi experiment' was conducted in a large dermatological hospital in italy: a questionnaire evaluating the decision-making process and knowledge on treatments was selfcompleted by a consecutive sample of psoriasis patients after routine clinical practice and by a second sample of patients exposed to a decision-board. results: in routine clinical practice . % of patients wanted to be involved in treatment decisions, . % wanted to leave decisions entirely to the doctor and . % preferred making decisions alone. . % and . % of the control and decision-board group had good knowledge level. at multivariate analysis good knowledge on treatments increased the likelihood of preferring an active role (or = . ; %ci . - . ; p = . ). the decision-board only marginally improved patient knowledge and doctor-patient communication. conclusion and discussion: in conclusion, large proportions of patients want to participate in decision-making, but insufficient knowledge can represent a barrier. further research is needed for developing effective instruments for improving patient knowledge and participation. abstract background: the only available means of controlling infections caused by the dengue virus is the elimination of its principal urban vector (aedes aegypti). brazil has been implementing programs to fight the mosquito; however, since the 's the geographic range of infestation has been expanding steadily, resulting in increased circulation of the virus. objective: to evaluate the effectiveness of the dengue control actions that have been implemented in the city of salvador. methods: prospective design, serologic inquiries were made in a sample population of residents of urban 'sentinel areas'.the seroprevalence and one year seroincidence of dengue are estimated and the relationship between intensity of viral circulation and the standards of living and vector density is analysed. results: there were high overall seroprevalence ( . %) and seroincidence ( . %) for the circulating serotypes (denv- and denv- ). the effectiveness of control measures appears to be low, and although a preventable fraction of . % was found, the incidence of infections in these areas was still very high ( . %). conclusions and discussions: it is necessary to revise the technical and operational strategies of the infection control program in order to attain infestation levels that are low enough to interrupt the circulation of the dengue virus. this study investigates the difference in cancer mortality risks between migrant groups and the native dutch population, and determines the extent of convergence of cancer mortality risks according to migrants' generation, age at migration and duration of residence. data were obtained from the national population & mortality registries in the period - ( person years, cancer deaths). we used poisson regression to compare the cancer mortality rates of migrants originating from turkey, morocco, surinam, netherlands antilles/aruba to the rates for the native dutch. results: all-cancer mortality among all migrant groups combined was significantly lower compared to the native dutch population (rr= . ci: . - . ). mortality rates for all cancers combined were higher among nd generation migrants, among those with younger age at migration, and those with longer duration of residence. this effect was particularly pronounced in lung cancer and colorectal cancer. for most cancers, mortality among nd generation migrants remained lower compared to the native dutch population. surinamese migrants showed the most consistent pattern of convergence of cancer mortality. conclusions: the generally low risk of cancer mortality for migrants showed some degree of convergence but the cancer mortality rates did not yet reach the levels of the native dutch population. abstract background: legionnaires' disease (ld) is a notifiable disease in the netherlands. ld cases are reported to authorities for national surveillance. supplementary, a national ld outbreak detection program (odp) is installed in the netherlands. these two registration systems have their own information exchange process and databases. objectives: surveillance systems are known to suffer from incompleteness of reported data. co-existence of two databases creates the opportunity to investigate accuracy and reliability in a national surveillance system. design and methods: comparison was made between the outcome 'diagnosis by culture' in both databases and physical presence of legionella strains in laboratories for patients. accuracy is described using the parameters sensitivity and correctness. for reliability, cohen's kappa coefficient (?) was applied. results: accuracy and reliability were significantly higher in the odp database, but not optimal in both databases when compared to data in laboratories. the odp database was moderately reliable (? = . ; %ci . - . ), the surveillance database slightly (? = . ; %ci . - . ). conclusion: our findings suggest that diagnostic notification data concerning ld patients are most accurate and reliable when derived directly from diagnostic laboratories. discussion: involvement of data-entry persons in outbreak detection results in higher reliability. unreliable data may have considerable consequences during outbreaks of ld. the aim of the study was to investigate the medical students' plans to emigrate, quantify the scale of migration in the near future and to build a profile of the possible emigrants. data were collected based on anonymous questionnaire delivered to random group of medical students (katowice). we used the binary logistic regression and multivariate analysis to identify the differences between groups preferring to go abroad or stay in poland. % respondents confirmed that considerate the emigration; . % of them declared they are very likely to move and further . % is certain. , % of those considering emigration confirmed having taken practical steps towards moving. binary logistic regression showed no difference between people who were certain or almost certain to go and those who were not considering going for most baseline characteristics: hometown size, socio economic background and having family tradition of the medical profession (p = . ). only marks' mean differentiates between the two groups: . for those who will definitely stay vs . for students who will definitely move (p = . ). the multivariate analysis gave similar results. conclusions: most of the students consider the emigration, but the declarations of will to departure are more frequent among those with the worse marks. abstract background: falls incidence in home resident elderly people varies from % to %. falls induce loss of self-sufficiency and increase mortality and morbidity. objectives: to evaluate falls incidence and risk factors in a group of general practice elderly patients. design : prospective cohort study with year follow-up methods: eight hundreds elderly (> years) were visited by practitioners for a baseline assessment. information on current pathologies and previous falls in the last six months was collected. functional status was evaluated using: short portable mental state questionnaire, geriatric depression scale, activities of daily living (adl), instrumental activities of daily living, total mobility tinetti score. falls were monitored through phone-interviews at and months. data were analyzed through logistic regression. results: twenty-eight percent of the elderly fell in the whole period. sixty percent of falls were not reported to the practitioner. independent predictors for falls were adl score (adl< : or = . ; % ci . - . ) and previous falls (or = . ; % ci . - . ). tinetti score was significantly associated to falls only in univariate analysis. conclusions: practitioners can play a key-role in identifying at-risk subjects and managing prevention interventions. falls monitoring and a continuous practice of comprehensive geriatric assessment should be encouraged. abstract background: oral health represents an important indicator of health status. socio-economic barriers to oral care among elderly are considerable. in the lazio region, a public health program for oral rehabilitation was implemented to offer dentures to elderly people with social security. objectives: to compare hospitalisation between elderly enrolled in the program and a control group. design and methods: for each elderly enrolled in the program living in rome, three controls, matched for sex and age, were selected from rome municipality register. hospital admissions in the two-year period before enrollment were traced by record-linkage with the hospital discharge register. results: totally, , admissions occurred. the annual admissions rate was per elderly among controls and in the program group (incidence rate ratio: irr = . ; % ci . - . ). when comparing diagnosis-specific rates, significant excesses were observed in the program group for respiratory diseases ( abstract background: herpes simplex virus (hsv) type and are important viral sexually transmitted diseases (sti) and can cause significant morbidity. in the netherlands, data about prevalences in the general population are hampered. objective: description of the seroprevalences of hsv- and hsv- and associated factors in the netherlands. design and methods: a population based serum bank survey in the netherlands with an age-stratified sample was used ( ) ( ) . antibodies against hsv- and hsv- were determined using elisa. a questionnaire was used to get information on demographics and risk factors. a logistic regression adjusting for age and full multiple regression were done to establish risk factors. results: questionnaires and sera were available for persons. both hsv- and hsv- seroprevalence increased with age. seroprevalence of hsv- was . % and was amongst others associated with female sex and being divorced. seroprevalence of hsv- was . % and was amongst others associated with being divorced and a history of sti. conclusion: seroprevalence is higher in certain groups like teenagers, women, divorced people and those with a history of sti. prevention should be focused on those groups. more research is needed on prevention methods, which can be used in the netherlands, like screening or vaccination. abstract background: frequently, statistically significant prognostic factors are reported with suggestions that patient management should be modified. however, the clinical relevance of such factors is rarely quantified. objectives: we evaluated the accuracy of predicting the need for invasive treatment among bph patients managed conservatively with alpha -blockers. methods: information on eight prognostic factors was collected from patients treated with alpha -blockers. with phm regression coefficients a risk score for retreatment was calculated for each patient. the analyses were repeated on groups of patients sampled from the original case series. these bootstrap results were compared to the original results. results: three significant predictors of retreatment were identified. the % of patients with the highest risk score had an -month risk of retreatment of only %. analyses of less than half of all the bootstrap samples resulted in the same three significant prognostic factors. the % of patients with the highest risk score in each of the samples experienced a highly variable risk of retreatment of % to %. conclusions: four of the five high risk patients would be overtreated with a modified policy. internal validation procedures may warn against the invalid translation of statistical significance into clinical relevance. background: e-cadherin expression is frequently lost in human epithelium derived cancers, including bladder cancer. for two genetic polymorphisms in the region of the e-cadherin gene (cdh ) promoter, a reduced transcription has been reported: a c/a single nucleotide polymorphism (snp) and a g/ga snp at bp and bp, respectively, upstream of the transcriptional start site. objective: we studied the association between both polymorphisms and the risk of bladder cancer. methods: patients with bladder cancer and population controls were genotyped for the ) c/ a and the ) g/ga promoter polymorphisms using pcr-rflp. results: a significantly increased risk for bladder cancer was found for a allele carriers compared to the homozygous c allele carriers (or . ; % ci: . - . ). the risk for the heterozygous and homozygous a allele carriers, was increased approximately . and -fold, respectively. the association was stronger for more aggressive tumors. we did not find any association between the ) g/ga snp and bladder cancer. conclusion: this study indicates that the ) c/a snp in the e-cadherin gene promoter is a low-penetrance susceptibility factor for bladder cancer. background: health problems, whether somatic, psychiatric or accident-related cluster within persons. the study of allostatic load as a unifying theme (salut) aims to identify risk factors that are shared by different pathologies and that could explain this clustering. studying patients with repetitive injuries might be helpful to identify risk factors that are shared by accident-related and other health problems. objectives: to study injury characteristics in repetitive injury (ri) patients as compared to single injury (si) patients. methods: the presented study included ri patients and si patients. medical records provided information about injury characteristics and patients were asked for possible causes and context. results: ri patients suffered significantly more from contusions than si patients ( % vs %). regarding the context, si patients were significantly more injured in traffic ( % vs %). in both groups most injuries were attributed to 'mere bad luck' (ri %, si %), closely followed by 'clumsiness or inattention' (ri %, si %). ri patients pointed out aggression or substance misuse significantly more often than si patients ( % vs %). conclusion: ri patients seem to have more 'at risk' behavior (i.e. aggression, impulsivity), which will increase their risk for psychiatric health problems. abstract background: breastfeeding may have a protective effect on infant eczema. bias as a result of methodological problems may explain the controversial scientific evidence. objective: we studied the association between duration of breastfeeding and eczema when taking into account the possible influence of reverse causation. design and methods: information on breastfeeding, determinants and outcomes at age one year was collected by repeated questionnaires in mother infant-pairs participating in the koala study ( cases of eczema). to avoid reverse causation, a periodspecific-analysis was performed in which only 'at risk' infants were considered. results: no statistically significant association between the duration of breastfeeding (> weeks versus formula feeding) and the risk of eczema in the first year was found (or . %ci . - . ). after excluding from the analysis all breastfed infants with symptoms of eczema reported in the same period as breastfeeding, also no statistical significant association was found for the duration of breastfeeding and eczema between and months (or . %ci . - . ). conclusion and discussion: in conclusion, no evidence was found for a protective effect of breastfeeding duration on eczema. this conclusion was strengthened by risk period-specific-analysis which made the influence of reverse causation unlikely. abstract background: the internet can be used to meet health information needs, provide social support, and deliver health services. the anonymity of the internet offers benefits for people with mental health problems, who often feel stigmatized when seeking help from traditional sources. objectives: to identify the prevalence of internet use for physical and mental health information among the uk population. to investigate the relationship of internet use with current psychological status. to identify the relative importance of the internet as a source of mental health information. design and methods: self-completion questionnaire survey of a random sample of the uk population (n = ). questions included demographic characteristics, health status (general health questionnaire), and use of the internet and other information sources. results: % of internet users had sought health information online, and % had sought mental health information. use was higher among those with current psychological problems. only % of respondents identified the internet as one of the most accurate sources of mental health information, compared with % who identified it as one of the sources they would use. conclusions: health service providers must recognise the increasing use of the internet in healthcare, even though it is not always regarded as being accurate. abstract old age is a significant risk factor for falls. approximately % of people older than are falling at least once a year, mostly in the own homes. resulting hip fractures cause at least partial immobility in - % of the affected persons. almost % are sent to nursing homes afterwards. in mecklenburg-west pomerania, ageing of the population proceeds particularly fast. to prevent falls and the loss of independent living a falls prevention module was integrated in a community-bbased study conducted in cooperation with a general practitioner (gp). in the patients homes' a trained nurse performed a test to estimate the falls risk of each patient and a consultation how to reduce risk, e.g. eye sight check, gymnastic exercise. in the feasibility study ( %) out of patients (average age years), agreed to a visiting of each room of their homes in search for tripping dangers. the evaluation was assisted by a standardized, computer-based documentation. the prevention module received a considerable acceptance despite the extensive home visiting. within one month the patients started to transfer advice into practice. during the first follow up visits of the nurse three patients reported e.g. to have started gymnastics and/or wear stable shoes. abstract background: the emergence of drug resistant m. tuberculosis (mtb) is an increasing problem in both developed and developing countries. objectives: investigation of isoniazid (inh) and rifampin (rif) susceptibility patterns among mtb isolates from patients. design and methods: in total sputum samples were collected. smears were prepared for acid fast staining and all the isolates were identified as m. tuberculosis by preliminary cultural and biochemical tests. the isolates were examined for inh and rifampin resistance using conventional mic method and pcr technique by using specific inh (kat g) and rifampin (rpo b) resistant primers. results: seven isolates were resistant to both inh and rifampin by mic method. in pcr technique, and out of above mentioned strains showed resistant to inh and rifampin respectively. coclusion: the epidemiology of drug resistance is . % in region of study which is significant. discussion: conventional mic method despite being time consuming is more sensitive for evaluation of drug resistance, however, pcr as a rapid and sensitive technique is recommended additionally to conventional method for having quicker results to start treatment and disease control management. abstract background and objectives: we studied in literature which design characteristics of food frequency questionnaires (ffqs) influence their validity to assess both absolute and relative levels of energy intake in adults with western food habits, and to rank them according to these intakes. this information is required in harmonizing ffqs for multi centre studies. design and methods: we performed a review of studies investigating the validity or reproducibility of ffqs, published since . the included studies validated ffqs against doubly labeled water (for energy expenditure) as a gold standard, or against food records or hour recalls for assessing relative validity (for energy intake). the design characteristics we studied were the number of food items, the reference period, the administration mode, and inclusion of portion size questions. results: and conclusion: for this review we included articles representing the validation of questionnaires. three questionnaires were validated against dlw, ten against urinary n and against -hour recalls or food records. in conclusion a positive linear relationship (r = . , p< . ) was observed between the number of items on the ffq and the reported mean energy intake. details about the influence of other design characteristics on validity will be discussed at the conference. abstract background: high ethanol intake may increase the risk of lung cancer. objectives: to examine the association of ethanol intake with lung cancer in epic. design and methods: information on baseline and past alcohol consumption, lifetime tobacco smoking, diet, and anthropometrics of , participants was collected between and . cox proportional hazard regression was used to examine the association of ethanol intake at recruitment ( cases) and mean lifelong ethanol intake ( cases) with lung cancer. results: non-consumers at recruitment had a higher lung cancer risk than low consumers ( . - . g/day) [hr = . , % ci . - . ]. lung cancer risk was lower for moderate ethanol intake at recruitment ( . - . g/day) compared with low intake (hr = . , % ci . - . ); no association was seen for higher intake. compared with lifelong low consumers, lifelong non-consumers did not have a higher lung cancer risk (hr = . , % ci . , . ) but lifelong moderate consumers had a lower risk (hr = . , % ci: . - . ). lung cancer risk tended to increase with increasing lifelong ethanol intake (= vs. . - . g/ day hr = . , % ci: . - . ). conclusion: while lung cancer risk was lower for moderate compared with low ethanol intake in this study, high lifelong ethanol intake might increase the risk. abstract background: one of the hypotheses to explain the increasing prevalence of atopic diseases (eczema, allergy and asthma) is imbalance between dietary intake of omega- and omega- fatty acids. objectives: we evaluated the role of perinatal fatty acid (fa) supply from mother to child in the early development of atopy. design and methods: fa composition of breast milk was used as a marker of maternal fa intake and placental and lactational fa supply. breast milk was sampled months postpartum from mother-infant pairs in the koala birth cohort study, the netherlands. the infants were followed for atopic symptoms (repeated questionnaires on eczema and wheezing) and sensitisation at age (specific serum ige against major allergens). multivariate logistic regression analysis was used to adjust for confounding factors. results: high levels of omega- long chain polyunsaturated fas were associated with lower incidence of eczema in the first year (odds ratio for the highest vs lowest quintile . , % confidence interval . - . ; trend over quintiles p = . ). wheeze and sensitisation were not associated with breast milk fa composition. conclusion and discussion: the results support the omega- / hypothesis. we suggest that anti-inflammatory activity of omega- eicosanoid mediators is involved but not allergic sensitisation. abstract background: acute myocardial infarction (ami) is among the main causes of death in italy and is characterized by high fatality associated with a fast course of the disease. consequently timeliness and appropriateness of the first treatment are paramount for a positive recovery. objectives: investigate the differences among italian regions of ami first treatment and in-hospital deaths. design and methods: following the theoretical care pathway (from onset of ami to hospitalization and recovery or death), regional in-hospital deaths are decomposed into the contributions of attack rate, hospitalization and in-hospital fatality. hospital discharges, death and population data are provided by the official statistics. results: generally in northern and central regions there is an excess of observed in-hospital deaths, while the opposite occurs in southern regions. conclusion: in northern and central regions the decomposition method suggests a more frequent and severe illness, generally accompanied by a higher availability of hospitals; exceptions are lombardia and lazio, where some inefficiencies in the hospital system are highlighted. in most southern regions the decomposition confirms a less frequent and less severe illness; exceptions are campania and sicilia, where only the less severe patients reach the hospital and then recover, while the others die before reaching the hospital. abstract background: atherosclerotic lesions have typical histological and histochemical compositions at different stages of their natural history. the more advanced atherosclerotic lesions contain calcification. objective: we examined the prevalence of and associations between calcification in the coronary arteries, aortic arch and carotid arteries assessed by multislice computed tomography (msct). methods: this study was part of the rotterdam study,a population-based study of subjects aged years and over. calcification was measured and quantified in subjects. correlation coefficients were computed using spearman's correlation coefficients. results: the prevalence of calcification increased with age throughout the vascular bed. in subjects aged and over, up to % of men had calcification in the coronary arteries and up to % of women had calcification in the aortic arch. in men, the strongest correlation was found between calcification in the aortic arch and the carotid arteries (r= . , p< . ). in women, the relations were somewhat lower, the strongest correlation was found between calcification in the coronary arteries and the carotid arteries (r = . , p< . ). conclusion and discussion: in conclusion, the prevalence of calcification was generally high and increased with increasing age. the study confirms the presence of strong correlations between atherosclerosis in different vessel beds. abstract background: health status deteriorates with age and can be affected by transition from active work to retirement. objective: to assess the effect of retirement on age related deterioration of health. methods: secondary analysis of the german health survey (bundesgesundheitssurvey ) and california health interview survey (chis ) . subjective health was assessed by a single question regarding respondent's health status from = excellent to = poor. locally weighted regression was used for exploratory analysis and b-splines for the effect estimation in regression models. results: subjective health decreased in an obviously non-linear manner with age. in both cases the decrease could be reasonably approximated by two linear segments, however the pattern was different in the german and california sample. in germany, the change point of the slope describing deterioration of health was located at . abstract objective: to assess the effectiveness of physiotherapy compared to general practitioners' care alone, in patients with acute sciatica. design, setting and patients: a randomised clinical trial in primary care with a -months follow-up period. patients with acute sciatica (recruited - ) were randomised in two groups: ) intervention group received physiotherapy (active exercises), and ) control group received general practitioners' care only. main outcome measures the primary outcome was patients' global perceived effect. secondary outcomes were severity of leg and back pain, severity of disability, general health and absence from work. the outcomes were measured at , , and weeks after randomisation. results: at months follow-up, % of the intervention group and % of the control group reported improvement (rr . ; % ci . to . ). at months follow-up, % of the intervention group and % of the control group reported improvement (rr . ; % ci . ; . ). no significant differences in secondary outcomes were found at short-term or long-term follow-up. conclusion: at months follow-up, evidence was found that physiotherapy added to general practitioners' care is more effective in the treatment of patients with acute sciatica than general practitioners' care alone. abstract background: only little is known about the epidemiology of skin melanoma in the baltic states. objectives: the aim of this study was to provide insights into the epidemiology of skin melanoma in lithuania by analyzing population-based incidence and mortality ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) time trends and relative survival based on skin melanoma. methods: we calculated age-standardized incidence and mortality rates (cases per , ) using the european standard population and calculated period estimates of relative survival. for the period - , % of all registered cases were checked by reviews of the medical charts. results: about % of the cases of the period - were reported to the cancer registry indicating a high quality of cancer registration of skin melanoma in lithuania. the incidence rates increased from (men: . , women: . ) to (men: . , women: . ). mortality rates increased from (men: . , women: . ) to (men: . , women: . ). relative -year relative survival rates among men were % lower than among women. the overall difference in survival is mainly due to a more favorable survival among women aged - years. conclusions: overall prognosis is less favorable among men most likely due to diagnoses at later stages. abstract background: only little is known about the epidemiology of skin melanoma in the baltic states. objectives: the aim of this study was to provide insights into the epidemiology of skin melanoma in lithuania by analyzing population-based incidence and mortality ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) time trends and relative survival based on skin melanoma. methods: we calculated age-standardized incidence and mortality rates (cases per , ) using the european standard population and calculated period estimates of relative survival. for the period - , % of all registered cases were checked by reviews of the medical charts. results: about % of the cases of the period - were reported to the cancer registry indicating a high quality of cancer registration of skin melanoma in lithuania. the incidence rates increased from (men: . , women: . ) to (men: . , women: . ). mortality rates increased from (men: . , women: . ) to (men: . , women: . ). relative -year relative survival rates among men were % lower than among women. the overall difference in survival is mainly due to a more favorable survival among women aged - years. conclusions: overall prognosis is less favorable among men most likely due to diagnoses at later stages. abstract background: multifactorial diseases share many risk factors, genetic as well as environmental. to investigate the unresolved issues on etiology of and individual susceptibility to multifactorial diseases, the research focus must move from single determinantoutcome relations to modification of universal risk factors. objectives: the aim of the lifelines project is to study universal risk factors and their modifiers for multifactorial diseases. modifiers can be categorized into factors that determine the effect of the studied risk factor (eg gen-expression), those that determine the expression of the studied outcome (eg previous disease), and generic factors that determine the baseline risk for multifactorial diseases (eg age). design and methods: lifelines is carried out in a representative sample of . participants from the northern provinces of the netherlands. apart from questionnaires and clinical measurements, a biobank is constructed (blood, urine, dna). lifelines will employ a three-generation family design (proband design with relatives), which has statistical advantages, enables unique possibilities to study social characteristics, and offers practical benefits. conclusion: lifelines will contribute to the understanding of how disease-overriding risk factors are modified to influence the individual susceptibility to multifactorial diseases, not only at one stage of life but cumulatively over time: the lifeline. abstract background: obesity-related mortality is a major public health problem, but few studies have been conducted on severely obese individuals. objectives: we assessed long-term mortality in treatment-seeking, severely obese persons. design and methods: we enrolled persons in six centres for obesity treatment in four italian regions, with body mass index (bmi) at first visit => kg/m and age => . after exclusion of duplicate registrations and persons with missing personal or clinical data, persons were followed up; as ( . %) could not be traced, persons ( men, women) were retained for analysis. results: there were ( men, women) deaths; the standardized mortality ratios (smrs) and % confidence intervals were ( - ) among men and ( - ) among women. mortality increased with increasing bmi, but the trend was not monotonic in men. lower smrs were observed among persons recruited more recently. excess mortality was inversely related to age attained at follow-up. conclusions and discussion: the harmful, long-term potential of severe obesity we documented confirms observations from studies carried out in different nutritional contexts. the decrease in mortality among most recently recruited persons may reflect better treatment of obesity and of its complications. abstract background: in finland, every cancer patient should have equal access to high quality care provided by the public sector. therefore no regional differences in survival should be observed. objectives: the aim of the study was to find any regional differences in survival, and to elaborate whether possible differences could be explained, e.g., by differences in distributions of prognostic factors. design and methods: the study material consisted of , patients diagnosed in to with cancer at one of the major primary sites. the common closing date was dec. . finland was divided into five university hospital regions. stage, age at diagnosis and sex were used as prognostic factors. the relative survival rates for calendar period window, - , were tabulated using period method and modelled. results: survival differences between the regions were not significant for most primary sites. for some sites, the differences disappeared in the modelling phase after adjusting for the prognostic factors. for a few of the primary sites (e.g., carcinoma of the ovary), regional differences remained after modelling. conclusion: we were able to highlight certain regional survival differences. ways to improve the equity of cancer care will be considered in collaboration with the oncological community. abstract background: the prevalence of cardiovascular disease (cvd) is extremely high in dialysis patients. disordered mineral metabolism, including hyperphosphatemia and hypercalcaemia, contributes to the development of cvd in these patients. objectives: to assess associations between plasma calcium, phosphorus and calciumphosphorus product levels and risk of cvd-related hospitalization in incident dialysis patients. design and methods: in necosad, a prospective multi-centre cohort study in the netherlands, we included consecutive patients new on haemodialysis or peritoneal dialysis between and . risks were estimated using adjusted time-dependent cox regression modeling. results: mean age was ± years, % was male, and % was treated with haemodialysis. cvd was the cause of hospitalization in haemodialysis patients ( % of hospitalizations) and in peritoneal dialysis patients ( %). most common cardiovascular morbidities were peripheral vascular disease and coronary artery disease in both patient groups. in haemodialysis patients risk of cvd-related hospitalization increased with elevated plasma calcium (hazard ratio: . ; % ci: . to . ) and calcium-phosphorus product levels ( . ; % ci: . to . ). in peritoneal dialysis patients, we observed similar effects that were not statistically significant. conclusion: tight control of plasma calcium and calcium-phosphorus product levels might prevent cvd-related hospitalizations in dialysis patients. abstract background: nurses are at health risk due to the nature of their work. analysis of morbidity among nurses was conducted to provide insight concerning the relationship between their occupational exposure and health response. methods: self reported medical history, was collected from an israeli female-nurses cohort (n = , + years old) and their siblings (n = , age matched +/) years) using a structured questionnaire. to compare disease occurrence between the two groups we used chi-square tests and hazard ratio (hr) was calculated by cox-regression to account for age of onset. results: cardiovascular diseases were more frequent among the nurses compared to the controls: heart diseases . % vs. . , p = . (hr= . , p = . ); hypertension . % vs. . %, p<. (hr= . , p = . ). the frequency of hyperlipidemia was . % among the nurses, and only . % among the controls. (hr= . ,p = . ). for the following chronic diseases the occurrence were significantly higher among the nurses and the hrs were significantly higher than : thyroid, hr= . ; liver, hr= . . total cancer and diabetes rates were similar in the groups (hr$ ). conclusions: the results suggest an association between working as a nurse and the existence of risk factors for cardiovascular diseases. the specific related determinants of their work should be further evaluated. abstract background: early referral (er) to a nephrologist and arteriovenous fistulae as first vascular access (va) reduce negative outcomes in chronic dialysis patients (cdp). objectives: to evaluate the effect of nephrologist referral timing and type of the first va on mortality. design and methods: prospective cohort study of incident cdp notified to lazio dialysis registry (italy) in - . late referral (lr) was a patient not referred to nephrologists within months before starting dialysis. we dichotomized va as fistulae versus catheters. to estimate mortality hazard ratios (hr) a multivariate cox model was performed. results: we observed . % lr subjects and . % catheters as first va; proportion of catheters was . % vs. . % (p< . ) for lr and er, respectively. we found a higher mortality hr for patient with a catheter as first va both for er (hr = . ; %c.i. = . - . ) and lr (hr = . ; %c.i. = . - . ); the interaction between referral and va was slight significant (p = . ). conclusions: the originality of our study was to investigate the influence of nephrologist referral timing and va on cdp mortality using a population registry, area-based: we found that a catheter as first va has an independent effect for mortality and modifies the effect of referral timing on this outcome. abstract patients with idiopathic venous thrombosis (vt) without known genetic risk factors but with a positive family history might carry yet unknown genetic defects. to determine the role of unknown hereditary factors in unexplained vt we calculated the risk associated with family history. in the multiple environmental and genetic assessment of risk factors for vt (mega) study, a large population-based case-control study, we collected blood samples and questionnaires on acquired risk factors (surgery, immobilisation, malignancy, pregnancy and hormone use) and family history of patients and control subjects. overall, positive family history was associated with an increased risk of vt (or ( % ci): . ( . - . )), especially in the absence of acquired risk factors (or ( % ci): . ( . - . ) ). among participants without acquired factors but with a positive family history, prothrombotic defects (factor v leiden, prothrombin a, protein c or protein s deficiency) were identified in out of ( %) patients compared to out of ( %) control subjects. after excluding participants with acquired or prothrombotic defects, family history persisted as a risk factor (or ( % ci): . ( . - . )). in conclusion, a substantial fraction of thrombotic events is unexplained. family history remains an important predictor of vt. abstract background: alcohol may have a beneficial effect on coronary heart disease (chd) through elevation of high-density lipoprotein cholesterol (hdlc) or other alterations in blood lipids. data on alcohol consumption and blood lipids in coronary patients are scarce. objectives: to assess whether alcohol consumption and intake of specific types of beverages are associated with blood lipids in older subjects with chd. design and methods: blood lipids (total cholesterol, hdlc, ldl cholesterol, triglycerides) were measured in myocardial infarction patients aged - years ( % male), as part of the alpha omega trial. intake of alcoholic beverages, total ethanol and macro and micronutrients were assessed by food-frequency questionnaire. results: seventy percent of the subjects used lipidlowering medication. mean total cholesterol was . mmol/l and hdlc was . mmol/l. in men but not in women, ethanol intake was positively associated with hdlc (difference of . mmol/l for = g/d vs. g/d, p = . ) after adjustment for diet, lifestyle, and chd risk factors. also, liquor consumption was weakly positively associated with hdlc in men (p = . ). conclusion and discussion: moderate alcohol consumption may elevate hdlc in (treated) myocardial infarction patients. this is probably due to ethanol and not to other beneficial substances in alcoholic beverages. session: posters session : july presentation: poster. abstract objective: early detection and diagnosis of silicosis among dust exposed workers is based mainly on the presence of rounded opacities on radiographs. it is thus important to examine how reliable the radiographic findings are in comparison to pathological findings. methods: a systematic literature search via medline was conducted. validity of silicosis detection and its influence on risk estimation in epidemiology was evaluated in a sensitivity analysis. results: studies on comparison between radiographic and pathological findings of silicosis were identified. the sensitivity of radiographic diagnosis of silicosis (ilo / ) varied between % and %, and specifity between % and %. under the realistic assumption of silicosis prevalence between % and % in dust exposed workers, % to % of silicosis identified may be falsely diagnosed. the sensitivity analysis indicates that invalid diagnostics alone may lead to the finding of an increased risk of lung cancer among patients with silicosis. it may also lead to findings of % to % of radiographic silicosis even when there is no case of silicosis. however, the risk of silicosis could also be underestimated if the prevalence of silicosis exceeds %. conclusion: epidemiological studies based on patients with silicosis should be interpreted with caution. abstract introduction: epidemics of dengue occurring in various countries have stimulated investigators to seek innovative ways of improving current knowledge on the issue. objective: to identify the characteristics of spatial-temporal diffusion of the first dengue epidemic in a major brazilian city (salvador, bahia). methods: notified cases of dengue in salvador in were georeferenced according to census sector (cs) and by epidemiological week. kernel density estimation was used to identify the spatial diffusion pattern. results: of the cs in the city, cases of dengue were registered in ( %). spatial distribution showed that in practically the entire city had been affected by the virus, with a greater concentration of cases in the western region, comprising cs of high population density and predominantly horizontal dwellings. conclusion and discussion: the pattern found showed characteristics of a contagious diffusion process. it was possible to identify the epicenter of the epidemic from which propagation initiated. the speed of progression suggested that even if a rapid intervention was initiated to reduce the vector population, it would probably have little effect in reducing the incidence of the disease. this finding confirms the need for new studies to develop novel technology for prevention of this disease. abstract background: knowing the size of drug user hidden populations in a community is important to plan and evaluate public health interventions. objectives: the aim of this study was to estimate the prevalence of opiate and cocaine users in liguria region by using the covariate capture-recapture method applied to four data sources. methods: we performed a cross-sectional study in the resident population aged - years ( . people at census). during individual cases identified as opiate or cocaine primary users were flagged by four sources (drug dependence services, social service at prefectures, therapeutic communities, hospital discharges). poisson regression models were fitted, adjusting for dependence among sources and for heterogeneity in catchability among categories of the two examined covariates: age ( - and - years) and gender. results: the prevalence of opiate or cocaine users was , % ( % c.i., , - , %) and , % ( % c.i.= , - , %) respectively. conclusions: the estimated prevalence of opiate and cocaine users is consistent with that found in inner london: . % and . % respectively (hickman m., ; hope v.d., ) . the covariate capture-recapture method applied to four data sources allowed identifying a large cocaine-using population and resulted appropriate to determine drug user hidden populations. abstract background: in - we performed a population based diabetes screening programme. objectives: to investigate whether the yield of screening is influenced by gp and practice characteristics. methods: a questionnaire containing items on the gp (age, gender, employment, specialty in diabetes, applying insulin therapy) and the practice (setting, location, number of patients from ethnic minority groups, specific diabetes clinic, involvement of practice assistant and practice nurse in diabetes care, cooperation with a diabetes nurse) was sent to general practitioners (gps) in practices in the southwestern region of the netherlands. multiple linear regression analysis was performed. outcome measure was the ratio screen detected diabetic patients/known diabetic patients per practice (sdm/kdm). results: sdm/kdm was independently associated with higher age of the gp (regression coefficient . ; % confidence interval . to . ), urban location () . ; ) . to ) . ) and involvement of the practice assistant in diabetes care ( . ; . to . ) . conclusion: a lower yield of screening, assumably reflecting a lower prevalence of undiagnosed diabetes, was found in practices of younger gps and in urban practices. a lower yield was not associated with an appropriate practice organization nor with a specialty of the gp in diabetes. session: posters session : july presentation: poster. background: since few years increased incidence rates for childhood cancer were reported from industrialized countries. these findings were discussed controversial, because increases could be caused by changing of potential risk factors. objectives: the question is: are observed increasing rates due to actual changes in incidence rates or mainly caused by changes in registration practice or artefacts? methods: for europe, data from the accis project (pooled data from european population-based cancer registries, performed at iarc, lyon; responsible: e. steliarova-foucher) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , and for germany, data of the german childhood cancer registry available from onwards were used. results: accis data (based on , cases) show significantly increased data with an overall average annual percentage change of about % and it is seen for mainly all diagnostic subgroups. for germany, increases are seen for neuroblastoma (due to screening programmes) and brain tumours (due to improved registration). for acute leukaemia the observed increase is explained by changes in classification. conclusion and discussion: the increased incidence for europe can only partly be explained by registration artefacts or improved diagnostic methods. the observed patterns suggest that an actual change exists. in germany, from till now the observed increased rates could be explained by artefacts. abstract suicide is the fourth most common cause of death among working age finns. among men socioeconomic status is strongly and inversely associated with suicide mortality, but little is known about socioeconomic differences in female suicide. we studied the direct and indirect effects of different socioeconomic indicators -education, occupation-based social class and income -on suicide among finnish women aged - . also the effect of main economic activity was studied. we used individual level data from the census linked to the death register for the years - . altogether over million person-years were included and suicides were committed. age-adjusted rii conducted using poissonregression model was . ( % ci . - . ) for education, . ( . - . ) for social class and . ( . - . ) for income. however, almost all of the effect of education was mediated by social class. fifteen per cent of social class was explained by education and per cent was mediated by income. the effect of income on suicide was mainly explained by economic activity. in conclusion, net of other indicators occupation-based social class is a strong determinant of socioeconomic differences in female suicide mortality, and actions aimed at preventing female suicide should target this group. abstract c-reactive protein levels (crp) in the range between and mg/ l independently predict the risk of future cardiovascular events. besides being a marker of atherosclerotic processes, high-normal crp levels may also be a sign of a more pronounced response to everyday inflammatory stimuli. the aim of our study is to assess the association between response to everyday stimuli and the risk of myocardial infarction. we will perform a population based case-control study including a total of persons. cases (n = ) are first myocardial infarction (mi) patients. controls (n = ) are partners of the patients. offspring of the mi patients (n = ) are included because disease activity and the use of medication by the mi patients may influence the inflammatory response. in order to assess the inflammatory response in mi patients the mean genetically determined inflammatory response in the offspring will be assessed and used as a measure for the inflammatory response in the mi patients. the offspring is free of disease and medication use. partners of the offspring (n = ) are the controls for the offspring. influvac vaccine will be given to assess crp concentration, i.e. inflammatory response, before and after the vaccination. abstract background:. ischemic heart disease risk may be influenced by long-term exposure to electromagnetic fields (emf) in vulnerable subjects, but epidemiological data is inconsistent. objectives: we studied whether the long-term occupational exposure to emf is related to an increased myocardial infarction (mi) risk. design and methods: we conducted a prospective case-control study, which involved mi cases and controls. emf exposure in cases and controls was assessed subjectively. the effect of emf exposure on mi risk was estimated using multivariate logistic regression. results: after adjustment for age, smoking, blood pressure, body mass index and psychological stress the odds ratios for emf exposure < years was . ; % ci . - . , for emf exposure - years - . ; % ci . - . and for emf exposure > years - . ; % ci . - . . conclusion: longterm occupational exposure to emf may increase the risk of mi. our crude estimates of emf exposure might have impact on excess risk because of nondifferential misclassification in assigning exposure. abstract background: it has been suggested that noise exposure is associated with ischemic heart disease risk, but epidemiological evidence is still limited. objectives: we studied whether road traffic noise exposure increases the risk of myocardial infarction (mi). design and methods: we conducted population-based prospective casecontrol study, which involved mi cases and controls. we measured traffic-related noise levels at the electoral districts and linked these levels to residential addresses. we used multiple logistic regression to assess effect of noise exposure on mi risk. results: after adjustment for age, smoking, blood pressure, body mass index, and psychological stress the risk of mi was higher for the men exposed to - dba ( background: some studies have suggested that patients, depressed following acute myocardial infarction (mi), experience poorer survival. however, i) other studies show no significant association, when adjusted for recognized prognostic indicators and ii) some 'natural' responses to mi may be recorded in questionnaires as indicators of depression. method: depression was assessed in mi patients, by interview on two measures (gwb and sf ) - weeks after discharge, clinical data were abstracted from patients' medical records and vital status was assessed at - years. survivals of depressed, marginally depressed and normal patients were calculated by kaplan meier method and comparisons made by log rank and cox proportional hazard modelling. results: crude survival at years in patients was higher for depressed and marginally depressed ( %) than for normals ( %), although not significantly. in multivariate analysis, four patient characteristics contributed significantly to survival: age (p< . ), previous mi (< . ), diabetes (< . ) and sex (< . ): other potential explanatory variables, including hypertension, infarct severity and depression were excluded by the model. abstract background: the low coronary heart disease (chd) incidence in southern europe could result in lower low density lipoprotein cholesterol oxidation (oxldl). objective. the aim of this study was to compare oxldl levels in chd patients from several european countries. methods: a cross-sectional multicenter study included stable chd male subjects aged to years from northen (finland and sweden), central (germany), and southern europe (greece and spain). lipid peroxidation was determined by plasma oxldl. results: the score of adherence to mediterranean diet, antioxidant intake, alcohol intake, and lipid profile were significantly associated with oxldl. oxldl levels were higher in northern ( . u/l) than in centre ( . u/l) and southern populations ( . u/l), p = . , in the adjusted models. the probability of northern europe to have the highest oxldl levels was . %, and . , % in logarithm of triglyceride-adjusted and fully adjusted models, respectively. the probability of this order to hold after adjustment for country was . %. conclusion: a gradient on lipoperoxidation from north to central and southern europe is very likely to exist, and parallels that observed in the chd mortality, and incidence rates. southern populations may have more favourable environmental factors against oxidation than northern europe. abstract background: whereas socioeconomic status (ses) has been established as a risk factor for a range of adverse health outcomes, little literature exists examining socio-economic inequalities in the prevalence of congenital anomalies. objectives: to investigate the relationship between the ses and the risk of specific congenital anomalies, such as neural tube defects (ntd), oral clefts (oc) and down's syndrome (ds). design and methods: a total of cases of congenital anomaly and non-malformed control births were collected between and from the italian archive of the certificates of delivery care. as a measure of ses, cases and controls were given a value for a level deprivation index. data were analysed using a logistic regression model. results: we found cases of dtn, cases of sof and cases of ds. the risk of having a baby with ntd was significantly higher for women of low ses (or = . ;c.i.: . - . ), as well as for oc (or = . ; c.i.: . - . ). no significant evidence for ses variation was found for ds. conclusion and discussion: our data suggest risk factors linked to ses, such as nutritional factors, lifestyle, and access to health services, may play a role in the occurrence of some malformations. abstract background: general practitioners (gp) are well-regarded by their patients and have the opportunity to play an active role in providing cessation advice. objectives: this study was run to examine whether a public health programme based on a carefully adapted programme of continuing education can increase gps' use of cessation advice and increase the success rates of such advice. methods: the particular context due to a randomization of gp leads us to consider a cluster randomization trial. marginal models, estimated by gee and mixed generalized linear models are used for this type of design. results: the cessation rate is relatively high for all smokers enrolled in the trial (n = ): a total of smokers were ex-smokers at one year ( . %). patients who were seen by trained gps were more likely to successfully stop smoking than those seen by the control gps ( . % vs . %). motivated subjects, aged over , lower had anxiety scores, and confidence in their ability to stop smoking, were predictive of successful cessation at one year follow-up. conclusions: cluster analysis indicated that factors important to successful cessation in this population of smokers are factors commonly found to influence cessation. abstract background: and purpose conventional meta-analysis showed no difference in primary outcome for coronary bypass surgery without (offpump) or with (onpump) the heart-lung machine. secondary outcome parameters such as transfusion requirements or hospitalization days favored offpump surgery. combined individual data analysis improves precision of effect estimates and allows accurate subgroup analyses. objective: our objective is to obtain accurate effect estimates for stroke, myocardial infarction, or death, after offpump versus onpump surgery, by meta-analysis on pooled individual patient data. method and results: bibliographic database search identified eleven large trials (> patients). the obtained data for trials data included patients. primary endpoint was composite (n = ), secondary endpoints were death (n = ), stroke (n = ) and myocardial infarction (n = ). hazard ratio for event-free survival after offpump vs onpump ( % ci) was: composite endpoint . ( . ; . ), death . ( . ; . ) myocardial infarction . ( . ; . ), stroke . ( . ; . ). after stratification for diabetes, gender and age the results slightly favored offpump for high-risk groups. hazard ratios remained not statistically significant. conclusion: no clinical or statistical significant differences were found for any endpoint or subgroup. offpump coronary bypass surgery is at least equal to conventional coronary bypass surgery. offpump surgery therefore is a justifiable option for cardiac surgeons for cardiac bypass surgery. in - an outbreak of pertussis occurred, mostly among vaccinated children. since then the incidence has remained high. therefore, a fifth dose with acellular booster vaccine for -yearolds was introduced in october . the impact of this vaccination on the age-specific pertussis incidence was assessed. mandatory notifications and hospitalisations were analysed for - and compared with previous years. surveillance data show 'epidemic' increases of pertussis in , , and . the total incidence/ , in ( . ) was higher than in the previous epidemic year ( . ). nevertheless, the incidence of notifications and hospitalisations in the age-groups targeted for the booster-vaccination had decreased with respectively % and % compared to . in contrast, the incidence in adolescents and adults almost doubled. unlike other countries that introduced a pre-school booster, the incidence of hospitalised infants < months also decreased ( % compared with ). as expected, the booster-vaccination for -year-olds has decreased the incidence among the target-population itself. more importantly, the decreased incidence among infants < months suggests that transmission from siblings to infants has also decreased. in further exploration of the impact of additional vaccination strategies (such as boostering of adolescents and/or adults) this effect should not be ignored. abstract acute respiratory infections (ari) are responsible for considerable morbidity in the community, but little is known about the presence of respiratory pathogens in asymptomatic individuals. we hypothesized that asymptomatic persons could have a sub clinical infection and so act as a source of transmission. between and all patients with ari who visited their sentinel general practitioner were reported to estimate the incidence of ari in dutch general practices. a random selection of them (cases) and an equal number of asymptomatic persons visiting for other complaints (controls) were included in a case-control study. nose/ throat swabs of participants were tested for a broad range of pathogens. the overall incidence of ari was per , person years, suggesting that in the dutch population an estimated , persons annually consult their general practitioner for respiratory complaints. viruses were detected in % of the cases, ?-haemolytic streptococci group a in % and mixed infections in %. besides, pathogens were detected in approximately % of controls, particularly in the youngest age groups. this study confirms that most ari are viral and supports the reserved policy of prescribing antibiotics. furthermore, we demonstrated that asymptomatic persons might be a neglected source of transmission. abstract background: the baking and flour producing industries in the netherlands agreed on developing a health surveillance system to reduce the burden of and improve prognosis of occupational allergic diseases. objectives: to develop and validate a diagnostic model for sensitization to wheat and fungal amylase allergens, as triage instrument to detect occupational allergic diseases. design and methods: a diagnostic regression model was developed in bakers from a cross-sectional study with ige serology to wheat and or amylase allergens as the reference standard. model calibration was assessed with hoshmer-lemeshow goodness of fit test; discriminative ability using area under receiver operating characteristic curve (auc); and internal validity using bootstrapping procedure. external validation was conducted in other bakers. results: the diagnostic model consisted of four questionnaire items (history of asthma, rhinitis, conjunctivitis, and work-related allergic symptom) showed good calibration (p = . ) and discriminative ability (auc . ; % ci . to . ). internal validity was reasonable (correction factor of . and optimism corrected auc of . ). external validation showed good calibration (p = . ) and discriminative ability (auc . ; % ci . to . ). conclusions and discussion: this easily applicable diagnostic model for sensitization to flour and enzymes shows reasonable diagnostic accuracy and external validation. abstract background: in the netherlands the baking and flour producing industries ( , small bakeries, industrial bakeries, and flour manufactures) agreed to reduce the high rate (up to %) of occupational related allergic diseases. objectives: to conduct health surveillance for early detection of occupational allergic diseases by implementing a diagnostic model as triage instrument. design and methods: in the preparation phase, a validated diagnostic regression model for sensitization to wheat and or a-amylase allergens was converted into score chart for use in occupational health practice. two cut off points of the sum scores were selected based on diagnostic accuracy properties. in the first phase, a questionnaire including the diagnostic predictors from the model was applied in . bakers. surveillance simulation was done in bakers recently enrolled in the surveillance. workers with high questionnaire scores were referred for advanced medical examination. results: implementing the diagnostic questionnaire model yielded %, %, and % bakers in the low, intermediate, and high score groups. workers with high scores showed the highest percentage of occupational allergic diseases. conclusions and discussion: with proper cut off points for referral, the diagnostic model could serve as triage instrument in health surveillance to early detect occupational allergic diseases. abstract background: the prevalence of cardiovascular risk factors in spain is high but myocardial infarction incidence is lower than in other countries. objective: to determine the role of basic lipid profile on coronary heart disease (chd) incidence in spain. methods: a cohort of , healthy spanish individuals aged to years was followed for years. the end-points were fatal and non-fatal myocardial infarction, and angina. results: the participants who developed a coronary end-point were significantly older ( vs ), more often diabetic ( % vs %), smoker ( % vs %) and hypertensive ( % vs %) than the rest, and their average total and hdl-cholesterols (mg/dl) were: vs (ns) and vs , (p< . ), respectively. chd incidence among individuals with low hdl levels (< in men/< in women) was higher than in the rest: . &aeyear- vs . &aeyear- (p< . ) in men, and . &aeyear- vs . &aeyear- (p< . ) in women. hdl-cholesterol was the only lipid related variable significantly associated with chd: hazard ratio for mg/dl increase was . ( % ci: . - . ) in men, and . ( % ci: . - . ) in women, after adjusting for classical risk factors. conclusion: hdl-cholesterol is the only classical lipid variable associated with chd incidence in spain. abstract background: it is widely recognized that health service interventions may reduce infant mortality/imr rate which usually occurs alongside with economic growth. however, there are reports showing that imr decrease under adverse economic and social conditions, indicating the presence of other unknown determinants. objective: this study aims to analyze temporal tendency of infant mortality in brazil during a recent period ( to ) of economic crisis. methods: temporal series study using data from the mortality information system, censuses (ibge) and epidemiological information (funasa). applying arima -autoregressive integrated moving average, it was described series parameters and, spearman correlation coefficients were used to evaluate the association between infant mortality coefficient and some determinants. results: the infant mortality showed a declining tendency () . %) and strong correlation to the majority of the indicators analyzed. however, only correlation between infant mortality coefficient and total fecundity and birth rates differed significantly within decades. conclusions/discussion: fecundity variation was responsible to the persistence of mortality decline during the eighties. in the next period those indicators of life conditions, mostly health care, could be more important. abstract background: across european union (eu) member states, considerable variation exists in the structure and performance of surveillance systems for communicable disease prevention and control. objectives: the study aims to support the improvement of surveillance systems of communicable diseases in europe while using benchmarking for the comparison of national surveillance systems. design and methods: surveillance systems from england & wales, finland, france, germany, hungary and the netherlands were described and analysed. benchmarking processes were performed with selected criteria (e.g. case definitions, early warning systems). after the description of benchmarks, best practices were identified and described. results: the six countries have in general wellfunctioning communicable disease control and prevention systems. nevertheless, different strengths and weaknesses in could be identified. practical examples for best practice from various surveillance systems demonstrated fields for improvement. conclusion and discussion: benchmarking national surveillance systems is applicable as a new tool for the comparison of communicable disease control in europe. a gold standard of surveillance systems in various countries is very difficult to achieve because of heterogeneity (e.g. in disease burden, personal and financial resources). however, to improve the quality of surveillance systems across europe, it will be useful to benchmark surveillance systems of all eu member states. abstract background: therapeutic decisions in osteoarthritis (oa) often involve trade-offs between accepting risks of side effects and gaining pain relief. data about the risk levels patients are willing to accept are limited. objectives: to determine patients' maximum acceptable risk levels (marls) for different adverse effects from typical oa medications and to identify the predictors of these risk attitudes. design and methods: marls were measured with a probabilistic threshold technique for different levels of pain relief. baseline pain and risk levels were controlled for in a x factorial design. clinical and sociodemographic characteristics were assessed using a selfadministered questionnaire. results: for subjects, marls distributions were skewed, and varied by level of pain relief, type of adverse effect, and baseline risk level. given a % baseline risk, for a -point ( - scale) pain benefit the mean (median) marls were . % ( %) for heart attack/stroke; . % ( %) for stomach bleed; . % ( . %) for hypertension; and . % ( . %) for dyspepsia. most clinical and sociodemographic factors were not associated with marls. conclusion: subjects were willing to trade substantial risks of side effects for pain benefits. this study provides new data on risk acceptability in oa patients that could be incorporated into practice guidelines for physicians. background: several independent studies have shown that single genetic determinants of platelet aggregation are associated with increased ihd risk. objectives: to study the effects of clustering prothombotic (genetic) determinants on the prediction of ihd risk. design and methods: the study is based on a cohort of , women, aged to years, who were followed from to . during this period, there were women with registered ihd (icd- - ) . a nested case cohort analysis was performed to study the relation of plasma levels vwf and fibrinogen, blood group genotype and prothrombotic mutations in the gene of a b , gpvi, gpib and aiibb to ihd. results: blood group ab, high vwf concentrations and high fibrinogen concentrations were associated with increased incidence of acute ihd. when the effects of blood group ab/o genotype, plasma levels fibrinogen and vwf were clustered with a score, there was a convincing relationship between a high prothrombotic score and increased incidence of acute ihd: the full-adjusted hr ( % confidence interval) was . ( . - . ) for women with the highest score when the lowest score was taken as reference. conclusions: clustering of prothrombotic markers is a major determinant of increased incidence of acute ihd. abstract background: studies have revealed heart rate variability (hrv) was a predictor of hypertension; however its h-recording has not been analysed with the -hour ambulatory blood pressure. objective: we studied the relationship between hrv and blood pressure. methods: hrv and blood pressure were measured by -hour ambulatory recordings, in randomly selected population without evidence of heart disease. cross-sectional analyses were conducted in women and men (mean age: . ± . ). hrv values, measured by the standard deviation of rr intervals (sdnn), were compared after logarithmic transformation between the blood pressure levels ( / mmhg), using analysis of variance. stepwise multiple-regression was performed to assess on sdnn the cumulative effects of systolic and diastolic blood pressure, clinical obesity, fasting glycaemia, c-reative protein, treatments, smoking and alcohol consumption. results: sdnn was lower in hypertensive men and women (p< . ), independently of drug treatments. after adjustment for factors associated with hypertension, sdnn was no more associated with hypertension, but with obesity, glycaemia and c-reative protein in both genders. sdnn was negatively associated with diastolic blood pressure in men (p = . ) in the multivariate approach. conclusion: whereas blood pressure levels were not related to the sdnn in the multivariate analysis, diastolic blood pressure contributed to sdnn in men. it has been proposed that n- fatty acids may protect against the development of allergic disease, while n- fatty acids may promote its development. in the piama (prevention and incidence of asthma and mite allergy) study we investigated associations between breast milk fatty acid composition of allergic and non allergic mothers and allergic disease (doctor diagnosed asthma, eczema or hay fever) in their children at the age of year and at the age of years. in children of allergic mothers prevalences of allergic disease at age and at age were relatively high if the breast milk they consumed had a low content (wt%) of n- fatty acids and particularly of n- long chain polyunsaturates (lcps), a low content of trans fatty acids, or a low ratio of n- lcps/n- lcps. the strongest predictor of allergic disease was a low breast milk n- lcps/n- lcps ratio (odds ratios ( % ci) of lowest vs highest tertile, adjusted for maternal age, parity and education: . ( . to . ) for allergic disease at age and . ( . to . ) for allergic disease at age ). in children of non allergic mothers no statistically significant associations were observed. abstract background/relevance: to find out about the appropriateness of using two vision related quality of life instruments to measure outcome of visually impaired elderly in a mono-and multidisciplinary rehabilitation centre. objective/design: to evaluate sensitivity of the vision quality of life core measure (vcm ) and the low vision quality of life questionnaire (lvqol) to measure changes in vision related quality of life in a non-randomised followup study. methods: visually impaired patients (n= ) recruited from ophthalmology departments administered questionnaires at baseline ( ) ( ) ( ) ( ) , months and year after rehabilitation. person measures were analysed using rasch analyses for polytomous rating scales. results: paired sample t-tests for the vcm showed improvement at months (p = . ; effect size = . and p = . ; effect size= . ) for the monodisciplinary and the multidisciplinary groups respectively. at year only the multidisciplinary group showed improvement on the vcm (p = . ; effect size = . ). on the lvqol, no significant improvement or deterioration was found for both groups. discussion: although, vcm showed improvement in vision related quality of life over time, the effect sizes appeared to be quite small. we conclude that both instruments lack sensitivity to measure changes. another explanation is that rehabilitation did not contribute to quality of life improvements. abstract background: the natural history of asthma severity is poorly known. objective: to investigate prognostic factors of asthma severity. methods: all current asthmatics identified in / in the european community respiratory health survey were followed up and their severity was assessed in by using the global initiative for asthma categorization (n = ). asthma severity was related to baseline/follow-up potential determinants by a multinomial logistic model, using intermittent asthmatics as reference category for relative risk ratios (rrr). results: patients in the lowest/highest levels of severity at baseline had an % likelihood of remaining in a similar level. severe persistent had a poorer fev %predicted at baseline, higher ige levels (rrr= . ; % ci: . - . ), higher prevalence of chronic cough/phlegm ( . ; . - . ) than intermittent asthmatics. moderate persistent showed similar associations. mild persistent were similar to intermittent asthmatics, although the former showed a poorer control of symptoms than the latter. subjects in remission had a lower probability of an increase in bmi than current asthmatics ( . ; . - . ). allergic rhinitis, smoking, respiratory infections in childhood were not associated with severity. conclusion: asthma severity is a relatively stable condition, at least for patients at the two extremes of the severity spectrum. high ige levels and persistent cough/phlegm are strong markers of moderate/severe asthma. abstract background: thyroid cancer (tc) has a low, yet growing, incidence in spain. ionizing radiation is the only well established risk factor. objectives: this study sought to depict the municipal distribution of tc mortality in spain and to argue about possible risk factors. design and methods: posterior distribution of relative risk for tc was computed using a single bayesian spatial model covering all municipal areas of spain ( , ) . maps were plotted depicting standardised mortality ratios, smoothed municipal relative risk (rr) using the besag, york and mollie`model, and the distribution of the posterior probability that rr> . results: from to a total of , tc deaths were registered in , municipalities. there was a higher risk of death in some areas of canary islands, galicia and asturias. abstract igf-i is an important growth factor associated with increased breast cancer risk in epidemiological and experimental studies. lycopene intake has been associated with decreased cancer risk. although some data indicate that lycopene can influence the igfsystem, this has never been extensively tested in humans. the purpose of this study is to evaluate the effects of a lycopene intervention on the circulating igf-system in women with an increased risk of breast cancer. we conducted a randomized, placebo-controlled cross-over intervention study on the effects of lycopene supplementation ( mg/day, months) in pre-menopausal women with ) history of breast cancer (n = ) and ) high familial breast cancer risk (n = ). drop-out rate was %. mean igf-i and igfbp- concentrations after placebo were . ± . ng/ml and . ± . mg/ml respectively. lycopene supplementation did not significantly alter serum total igf-i (mean lycopene effect: ) . ng/ml; % ci: ) . - . ) and igfbp- () . mg/ml; ) . - . ) concentrations. dietary energy and macronutrient intake, physical activity, body weight, and serum lycopene concentrations were assessed, and are currently under evaluation. in conclusion, this study shows that months lycopene supplementation has no effect on serum igf-system components in a high risk population for breast cancer. abstract introduction: patients who experience burden during diagnostic tests may disrupt these tests. the aim was to describe the perception of melanoma patients with lymph node metastases of the diagnostic tests. methods: patients were requested to complete a self-administrated questionnaire. experienced levels of embarrassment, discomfort and anxiety were calculated, as well as (total) scores for each burden. the non-parametric friedman test for related samples was used to see if there was a difference in burden. results: the questionnaire was completed by patients; response rate was %. overall satisfaction was high. in total % felt embarrassment, % discomfort and % anxiety. overall, % felt some kind of burden. there was no difference in anxiety between the three tests. however, patients experienced more embarrassment and discomfort during the pet (positron emission tomography) scan (p = . and p = . ). conclusion: overall levels of burden were low. however, patients experienced more embarrassment and discomfort during the pet scan, possibly as a result of lying immobile for a long time. the accuracy, costs and patients upstaged will probably be the most important to determine the additional value of fdg-pet and ct, but it is reassuring to know that only few patients experience severe or extreme burden. abstract gastric cancer (gc) is the second most frequent cause of cancer death in lithuania. some intercultural aspects of diet that is related to the outcome could be the risk factors of the disease. the objective of the study was to assess an associations between risk of gc and dietary factors. a case-control study included cases with diagnose of gc and controls that were cancer and gastric diseases free. a questionnaire used to collect information on possible risk factors. the odds ratios (or) and % confidence intervals (ci) estimated by the conditional logistic regression model. after controlling for possible confounders that were associated with gc, use of salted meat (or = . ; % ci = . - . ; > - times/week vs. almost never) smoked meat (or = . ; % ci = . - . ; > - times/week vs. less), smoked fish (or = . ; % ci = . - . ; > - times/week vs. less) was associated with increased risk of gc. higher risk of gc was associated with frequent use of butter, eggs and noodles. while frequent consumption of carrots, cabbages, broccolis, tomatoes, garlic, beans decreased the risk significantly. the data support a role of salt processed food and some animal foods in increasing the risk of gc and plant foods in reducing the risk of the disease. abstract background: standards for the evaluation of measurement properties of health status measurement instruments (hsmi), including explicit criteria for what constitutes good measurement properties, are lacking. nevertheless, many systematic reviews have been performed to compare and select hsmi, using different criteria to judge the measurement properties. objectives: ( ) to determine which measurement properties are reported in systematic reviews of hsmi and how these properties are defined, ( ) which standards are used to define how measurement properties should be assessed, and ( ) which criteria are defined for good measurement properties. methods: a systematic literature search was performed in pubmed, embase and psychlit. articles were included if they met the following inclusion criteria: ( ) systematic review, ( ) hsmi were reviewed, and ( ) the purpose of the review is to identify all measurement instruments assessing (an aspect of) health status and to report on the clinimetric properties of these hsmi. two independent reviewers selected the articles. a standardised data-extraction form was used. preliminary results: systematic reviews were included. conclusions: large variability in standards and criteria used for evaluating measurement properties was found. this review can serve as basis for reaching consensus on standards and criteria for evaluating measurement properties of hsmi. abstract residential exposure to nitrogen dioxide is an air quality indicator and could be very useful to assess the effects of air pollution on respiratory diseases. the present study aims at developing a model to predict residential exposure to no , combining data from questionnaires and from local monitoring stations (ms). in the italian centres of verona, torino and pavia, participating in ecrhs-ii, no concentrations were measured using passive samplers (ps-no ) placed outside the kitchen of subjects for days. simultaneously, average no concentrations were collected from all the mss of the three centres (ms-no ). a multiple regression model was set up with ps-no concentrations as response variable and questionnaire information and ms-no concentrations as predictors. the model minimizing the root mean square error (rmse), obtained from a ten fold cross validation, was selected. the model with the best predictive ability (rmse= . ), had as predictors: ms-no concentrations, season of the survey, centre, type of building, self-reported intensity of heavy vehicle traffic. the correlation coefficient between predictive and observed values was . ( % ci: . - . ). in conclusion, this preliminary analysis suggests that the combination of questionnaire information and routine data from the mss could be useful to predict the residential exposure to no . abstract background: currently only % of dutch mothers comply with the who recommendation to give exclusive breastfeeding for at least six months. therefore, the dutch authorities consider policies on breastfeeding. objectives: quantification of the health effect of several breastfeeding policies. methods: a systematic literature search of published epidemiological studies conducted in the general 'western' population. based on this overview a model is developed. the model simulates incidences of diseases of mother and child depending on the duration that mothers breastfeed. each policy corresponds to a distribution in the duration of breastfeeding. the health effects of each policy are compared to the present situation. results: breastfeeding has beneficial health effects on both the short and the long term for mother and child. the longer the duration of breastfeeding, the larger is the effect. most public health gain is achieved by introducing breastfeeding to all newborns rather than through a policy focusing just on extending the lactation period of women already breastfeeding. conclusion: breastfeeding has positive health effects. policy should focus preferentially on encouraging all mothers to start with breastfeeding. abstract background: constant increase of international trade and travel activities has risen the significance of pandemic infectious diseases worldwide. the / sars outbreak rapidly spread from china to countries, from which were located in europe. in order to control and prevent pandemic infections in europe, systematic and effective public health preparation by every member state is essential. method: supported by the european commission, surveys focusing on national sars (september ) and influenza (october ) preparedness were accomplished. a descriptive analysis was undertaken to identify differences in european infectious disease policies. results: guidelines and guidance for disease management were well established in most european countries. however, the application of control measures, like e.g. measures for mass gatherings or public information policies, had varied among member states. discussion: the results show that european countries are aware of preparing for pandemic infections. yet, the effectiveness of certain control measures is analysed insufficiently. further research and detailed knowledge about factors influencing international spread of diseases is required. 'hazard analysis of critical control points' (haccp) will be applied to evaluate national health response in order to provide comprehensive data for recommendations to european pandemic preparedness. abstract background: influenza is still an important problem for public health. knowing its space-time evolution is of special interest in order to carry out prevention plans. objectives: to analyze the geographical diffusion of the epidemic wave in extremadura. methods: the influenza incidence absolute rates in every town have been calculated, according to the registered cases per week in the compulsory disease declaration system. continuous maps have been represented using a geographical interpolation method (inverse distance weighting (idw) was applied with weighting exponents of ). results: the / season began in the th week of , with a small influenza incidence. there have been concrete cases in those towns until the th week. punctual areas diffusion in the north and southwest of the region between the th and the st weeks. the highest incidence appeared between the nd week of and the rd of . influenza cases started to decrease in the northwest and north of the region from the rd week of , till the th week, when most of the cases were found in the southwest. conclusion: there is a space-time diffusion of influenza, due to the higher population density. we propose to analyze these data combining temperature information. abstract background: acute lower respiratory tract infection (lrti) can cause various complications leading to morbidity and mortality notably among elderly patients. antibiotics are often given to prevent complications. to minimise costs and bacterial resistance, antibiotics are only recommended in case of pneumonia or in patients at serious risk for serious complications. objective: we assessed the course of illness of lrtis among dutch elderly primary care patients and assessed whether gps were inclined to prescribe antibiotics more readily to patients at risk for complications. methods: we retrospectively analysed medical data from , episodes of lrti among patients? years of age presenting in primary care to describe the course of illness. the relation between prescriptions of antibiotics and patients with risk factors for a complicated course was assessed by means of multivariate logistic regression. results: in episodes of acute bronchitis antibiotics were more readily prescribed to patients aged years or older. in exacerbations of copd or asthma gps favoured antibiotics in male patients and when diabetes, neurological disease or dementia was present. conclusion: gp's do not take all high risk conditions into account when prescribing antibiotics to patients with lrti despite recommendations of national guidelines. abstract background: the putative association between antidepressant treatment and increased suicidal behaviour has been under debate. objectives: to estimate the risk of suicide, attempted suicide, and overall mortality during antidepressant treatments. design and methods: study cohort consisted all subjects without non-affective psychosis, hospitalized due to a suicide attempt during the years - , followed up by using nationwide registers. main outcome were completed suicides, attempted suicides, and mortality. main explanatory variable was antidepressant usage. results: suicides, suicide attempts and deaths were observed. when the effect of background variables was taken into account, the risk of suicide attempts was increased markedly during antidepressant treatment (rr for selective serotonin reuptake inhibitors or ssri . , . - . ) compared with no antidepressants. however, the risk of completed suicides was not increased. a lower mortality was observed during ssri use (rr . , . - . ), which was mainly attributable to decrease in cardiovascular deaths. conclusion and discussion: in this suicidal high risk cohort the use of any antidepressant is associated with an increased risk of suicide attempts, but not with the increased risk of completed suicide. antidepressants and, especially, ssri use is associated with a substantial decrease in cardiovascular deaths and overall mortality. abstract background: the quattro study is a rct on the effectiveness of intensified preventive care in primary health care centres in deprived neighbourhoods. additional qualitative research on the execution of interventions in primary care was considered necessary for the explanation of differences in effectiveness. objectives: our question was: can we understand rct outcomes better with qualitative research? design and methods: an ethnographic design was used. in their daily work we observed researchers for months days a week, and practice nurses for days each. two other practice nurses were interviewed. all transcribed observations were analysed thematically. results: from the rct showed differences in effectiveness among the centres and that intensified preventive care provided no additional effect compared to structural physical measurements. ethnographic results show that these differences are due to variations in execution of the intervention among the centres. conclusion: in conclusion ethnographic analysis showed that differences in execution of intervention lead to differences in rct outcomes. the rct conclusion 'no additional effect' is problematic. discussion as variations in primary care influence a rcts' execution they create methodological problems for research. to what extent can additional qualitative research improve rct research. abstract background: acute myocardial infarction is the most important cause of morbidity from ischemic heart disease (ihd) and is the leading cause of death in the western world. objectives: to assess the benefits and harms of 'dan shen' compound for acute myocardial infarction. methods: we searched the cochrane controlled trials register on the cochrane library, medline, embase, chinese biomedical database and the chinese cochrane centre controlled trials register. we included randomized controlled studies lasting at least days. main results: eleven studies with participants in total were included. seven studies compared the mortality in routine treatment plus 'dan shen' compound and single routine treatment. one trial compared the arrhythmia in routine treatment plus 'dan shen' compound injection and single routine treatment. two trials compared the revascularization in routine treatment plus 'dan shen' compound injection and single routine treatment. conclusions: evidence is insufficient to recommend the routine use of 'dan shen' compound because of the small number of included studies and their low quality. no well designed randomized controlled trials with adequate power to provide a more definitive answer have been conducted. in addition, the safety of 'dan shen' compound is unproven, though adverse events were rarely reported. abstract antimicrobial resistance is emerging. to identify the scope of this threat and to be able to take proper actions and evaluate these, monitoring is essential. the remit of earss is to maintain a comprehensive surveillance system that provides comparable and validated data on the prevalence and spread of major invasive bacteria with clinically and epidemiologically relevant antimicrobial resistance in europe. since , earss collects routine antimicrobial susceptibility test (ast) results of invasive isolates of five indicator bacteria, tested according to standard protocols. in , ast results for , isolates were provided by laboratories, serving hospitals, covering million inhabitants in countries. through a biannual questionnaire denominator information was collected. the quality of ast results of laboratories was evaluated by the yearly external quality assessment. currently, earss includes all member and candidate states ( ) of the european union, plus israel, bosnia, bulgaria and turkey. participating hospitals treat a wide range of patients and laboratory results are of sufficient validity. earss identified antimicrobial resistance time trends and found a steady increase for most pathogen-compound combinations. in conclusion, earss is a comprehensive system with sufficient quality to show that antimicrobial resistance is increasing in europe and threatens health-care outcomes. abstract introduction: since chloroform has been detected in drinking waters, the number of studies has increased to identify the presence of trihalomethanes (thms) in drinking waters, as well as to establish the possible effects they may have population health. objectives: to determine thms levels in the water distributing network in the city of valencia. design and methods: over a one-year period, points of the drinking water distributing netowrk have undergone sampling at week intervals. the concentration of these pollutants was determined by gas chromatography. results: our results showed greater concentrations of the species substituted by chlorine and bromine atoms (dichlorobromomethane and dibromochloromethane) in the range of - z lg/l for both, - lg/l for trichloromethane and between - lg/l for tribromomethane. an increase in thms concentration was observed in those points near the sea, although they did not exceed the legal limit of lg/l. conclusion: we established two areas of concentration of these species in water: high and average, according to their proximity to the sea. abstract background: childhood cancer survivors are known to be at increased risk for second malignancies. objectives: we studied longterm risk of second malignancy in -year survivors, according to therapy and follow-up interval. methods: the risk of second malignancies was assessed in -year survivors of childhood cancer treated in the emma children's hospital amc in amsterdam and compared with incidence in the general population of the netherlands. complete follow-up till at least january was obtained for . % of the patients. the median follow-up time was . . results: sixty second malignancies were observed against . expected, yielding a standardized incidence ratio (sir) of ). the absolute excess risk (aer) was . per , persons per year. the sir appeared to stabilize after years of follow-up, but the absolute excess risk increased with longer follow-up (aer follow-up > = years of . ). patients who were treated with radiotherapy experienced the greatest increase of risk. conclusions: in view of the quickly increasing background rate of cancer with ageing of the cohort, it is concerning that even after more than years of follow-up the sir is still increased, as is the absolute excess risk. the chek * delc germline variant has been shown to increase susceptibility for breast cancer and could have an impact on breast cancer survival. this study aimed to determine the proportion of chek * delc germline mutation carriers, and breast cancer survival and tumor characteristics, compared to non-carriers in an unselected (for family history) breast cancer cohort. women with invasive mammary carcinoma, aged < years and diagnosed in several dutch hospitals between and , were included. for all patients, paraffin embedded tissue blocks were collected for dna isolation (normal tissue), and subsequent mutation analyses, and tumor revision. in breast cancer patients, ( . %) chek * delc carriers were detected. chek * delc tumors characteristics, treatment and patient stage did not differ from those of non-carriers. chek * delc carriers had times increased risk of developing a second breast cancer compared to non-carriers. with a mean follow up of years, chek * delc carriers had worse recurrence free and breast cancer specific survival than non-carriers. in conclusion, this study indicates a worse breast cancer outcome in chek * -delc carriers compared to non-carriers. the extension of the presence of the chek * delc germline mutation warrants research into therapy interaction and possibly into screening of premenopausal breast cancer patients. abstract background: for primary or secondary prevention (e.g. myocardial infarction) hormone therapy (ht) is no longer recommended in postmenopausal women. however, physicians commonly prescribe ht to climacteric women as a treatment of hot flashes/night sweats. objective: to assess efficacy and adverse reactions of ht in climacteric women with hot flashes (including night sweats). methods: for our systematic review (sr), we searched databases (medline, embase, cochrane) for randomized controlled trials, other srs and meta-analyses, published to . the quality of the studies was assessed using checklists corresponding to the study type. results: we identified studies of good/excellent quality. they included predominantly caucasian women and lasted - months. in all studies, ht showed a reduction of - % in the number of hot flashes, which was significantly better than placebo. most common adverse events of ht were uterine bleeding and breast pain/tenderness. cardiovascular diseases and neoplasms were reported only sporadically. conclusions: ht is highly effective in treating hot flashes in climacteric women. however, to assess serious adverse events longer studies (including also non-caucasian women) are needed, as there are only sparse data available. abstract igf-i is an important growth factor, and has been associated with increased colorectal cancer risk in both prospective epidemiological and experimental studies. however, it is largely unknown which lifestyle factors are related to circulating levels of the igf-system. studies investigating the effect of isoflavones on the igf-system have thus far been conflicting. the purpose of this study was to evaluate the effects of isoflavones on the circulating igf-system in men with high colorectal cancer risk. we conducted a randomized, placebo-controlled, cross-over study on the effect of a -month isoflavone supplementation ( mg/day) on igf levels in men with a family history of colorectal cancer or a personal history of colorectal adenomas. dropout rate was %, and all but men were more than % compliant. isoflavones supplementation did not significantly alter serum total igf-i () . %; %ci: ) . - . ) and igf binding protein (+ . %, %ci: ) . - . ) concentrations. other covariables, e.g. dietary energy and macronutrient intake, physical activity, and body weight, are currently under evaluation. in conclusion, this study shows that a -month isoflavone supplementation has no effect on serum igf-system components in men with high colorectal cancer risk. abstract background/objective: eurociss-european cardiovascular indicators surveillance set project, funded under the health monitoring programme of european commission, aims developing health indicators and recommendations for monitoring cardiovascular diseases (cvd). methods: prioritise cvd according to their importance in public health; identify morbidity and mortality indicators; develop data collection and harmonizing recommendations; describe data collection, validation procedures and discuss their comparability. population (geographical area, age, gender), methods (case definition, icd codes), procedures (record linkage, validation), morbidity indicators (attack rate, incidence, case fatality) collected by questionnaire. results: the main outcome was the inventory of acute myocardial infarction (ami) populationbased registers in the european partner countries: countries have no register, regional, of which also national. registers differ for: icd codes (only ami or also acute and subacute ischemic forms), ages ( - , - , all) , record linkage (probabilistic, personal identification number), calendar years, validation (monica, esc/acc diagnostic criteria). differences make morbidity indicators difficult to compare. conclusion: new diagnostic criteria led to a more exhaustive definition of myocardial necrosis as acute coronary syndrome (acs). given the high burden of ami/acs, efforts are needed to implement population-based registers in all countries. application of recommended indicators, validated through standardized methodology, will provide reliable, valid and comparable data. abstract objective: the objective of this paper was to compare and discuss the use of odd ratios and prevalence ratios using real data with complex sampling design. method: we carried out a cross-sectional study using data obtained from a two-stage stratified cluster sample from a study conducted in - (n = , ) . odds ratios and prevalence ratios were obtained by unconditional logistic regression and poisson regression, respectively, for later comparison using the stata statistical package (v. . ). confidence intervals and design effects were considered in the evaluation of the precision of estimates. two outcomes of a cross-sectional study with different prevalence were evaluates: vaccination against influenza ( . %) and self-referred lung disease ( . %). results: in the high-prevalence scenario, using prevalence ratios the estimates were more conservative and we found narrower confidence intervals. in the low-prevalence scenario, we found no important differences between the estimates and standard errors obtained using the two techniques. discussion: however, it is the researcher's task to choose which technique and measure to use for each set of data, since this choice must remain within the scope of epidemiology. abstract background: in italy coronary heart disease chd mortality has been falling since the s. objective: to examine how much of the fall between and could be attributed to trends in risk factors, medical and surgical treatments. methods: a validated model was used to combine and analyse data on uptake and effectiveness of cardiological treatments and risk factor trends. published trials, meta-analyses, official statistics, longitudinal studies, surveys are main data sources. results: chd mortality fell by % in men and % in women aged - ; , fewer deaths in . approximately half mortality fall was attributed to treatments in patients and half to population changes in risk factors: in men, mainly improvements in cholesterol ( %) and smoking ( %) rather than blood pressure ( %). in women / mortality fall attributable to improvements in cholesterol ( %) and blood pressure ( %); adverse trends in smoking () %). adverse trends also in bmi () % in both genders) and diabetes () % in men; ) . % in women). conclusion: half chd mortality fall was attributable to risk factors reductions, principally cholesterol in men and women and smoking in men; in women rising smoking rates generated substantial additional deaths. a comprehensive strategy promoting primary prevention is needed. objective: to investigate the efficacy of ni in the post exposure prophylaxis (pep), i.e. in persons who had contact with an influenza case. design and methods: we conducted a systematic electronic data base review for the period between and . studies were selected and graded by two independent reviewers. the proportion of influenza-positive patients was chosen as primary outcome. for all analyses fixed effect models were used. weighted relative risks (rr) and % confidence intervals (ci) were calculated on an intention-to-treat basis. results: randomized controlled trials (n= , ) were included in the analysis. zanamivir and oseltamivir were effective against an infection with influenza (rr= . , % ci . - . and rr= . , % ci . - . , respectively). prophylactic efficacy was comparable in the subgroup of persons who had contact with an index case with lab-confirmed influenza ( studies, all ni, rr= . , % ci . - . ). conclusions: the available evidence suggests that ni are effective in the pep of influenza. discussion: results have to be interpreted with caution when transferred into general medical practice because study populations mainly included young and healthy adults without chronic diseases. abstract an important risk factor of breast cancer, mammographic breast density (mbd) is inversely associated with reproductive factors (age at first childbirth, and lactating). as pregnancy and lactating are highly correlated, whether this decline is induced by pregnancy or lactating is still unclear. we hypothesize that lactation reduces mbd independent of age at first pregnancy and parity. a study was done on women in the third sub-cohort of the dom project who had complete data regarding lactating, dy, had a child but varied by duration of lactating. multiple logistic regression analysis was done using dy (yes/ no) as outcome variable. explanatory variables added into the model were age, bmi, parity and age at first childbirth. a significant univariate relation was seen between lactating of the first child and dy. or . (ci % . ; . ). adjusted for explanatory variables, the or changed to . (ci % . ; . ). lactating seems to contribute independently to the reduction of mbd over and above pregnancy itself. given the limitations of the dichotomous dy ratio scores, additional studies will address which part; either glandular mass or fat tissue is responsible for the observed relation which will be measured from mammograms to be digitized. abstract background: alcohol consumption is common, but little is known about whether drinking patterns vary across geographic regions. objectives: to examine potential disparities in alcohol consumption across census regions and urban, suburban, and rural areas of the united states. design and methods: the data source was the national epidemiologic survey on alcohol and related conditions, an in-person interview of approximately , adults. the prevalence of abstinence and, among drinkers, the prevalences of heavy and daily drinking were calculated by census region and metropolitan status. multivariate logistic regression analyses were conducted to test for differences in abstinence and per drinker consumption after controlling for confounders. results: the odds of abstinence, heavy, and daily drinking varied widely across geographic areas. additional analyses stratified by census region revealed that rural residents in the south and northeast as well as urban residents in the northeast had higher odds of abstinence. rural residents in the midwest had higher odds of heavy drinking. conclusion and discussion: heavy alcohol consumption is of particular concern among drinkers living in the rural areas of the united states, particularly the rural midwest. other nations should consider testing for similar differences as they implement policies to promote safe alcohol consumption. abstract background: long-term exposure to particulate air pollution (pm) has been suggested to accelerate atherogenesis. objective: we examined the relationship between long-term exposure to traffic emissions and the degree of coronary artery calcification (cac), a measure of atherosclerosis. methods: in a population based, crosssectional study, distances between participants' home addresses and major roads were calculated with a geographic information system. annual mean pm . -exposure at the residence was derived from a small scale geostatistical model. cac, assessed by electronbeam computer tomography, was modelled with linear regression by proximity to major roads, controlling for background pm . air pollution and individual level risk factors. results: of participants lived within m of a major road. background-pm . ranged from . to . lg/m (mean . ). mean cacvalues were strongly dependent on age, sex and smoking status. reducing the distance to major roads by % leads to increases in cac by . % ( %ci . - . %) in the unadjusted model and , % ( %ci ) . - . ) in the adjusted model. stronger effects (adjusted model) were seen in men ( , %, %ci ) . - . ) and male non-smokers ( , %, %ci ) . - . ). conclusions: this study provides epidemiologic evidence that long-term exposure to traffic emissions is an important risk factor for coronary calcification. abstract background: this polymorphism has been associated risk factor levels and in one study with a reduced risk of acute myocardial infarction (ami). yet, the risk relation has not been confirmed. objectives: we investigated the role of this polymorphism on occurrence of ami, coronary heart disease (chd) and stroke in healthy dutch women. design and methods: a case-cohort study in a prospective cohort of initially healthy dutch from until january st . results: we applied a cox proportional hazards model with an estimation procedure adapted for case-cohort designs. a lower ami (n= ) risk was found among carriers of the ala allele (n= ) compared with those with the more common pro pro genotype (hazard ratio= . ; % ci, . to . ). no relation was found for chd (n= ;hr . ; % ci, . - . ) and for stroke (n= ;hr . ; % ci, . - . ). in our data little evidence was found for a relation between pparg and risk factors. conclusion and discussion: this study shows the pro ala polymorphism in pparg gene is modestly related to a reduced risk of ami in our study. no statistically significant relation was found for chd and stroke. abstract background: pseudo cluster randomization was used in a services evaluation trial because individual randomization risked contamination and cluster randomization risked selection bias due to expected treatment arm preferences of recruiting general practitioners (gps). gps were randomized in two groups. depending on this randomization, participants were randomized in majority to one study arm: intervention:control/ : or intervention:control/ : . objectives: to evaluate internal validity of pseudo cluster randomization. have gps treatment arm preferences? what is the effect on allocation concealment and selection bias? design and methods: we compared the baseline characteristics of participants to study selection bias. using a questionnaire, gps indicated their treatment arm preferences on a visual analogue scale (vas) and the allocation proportions they believed were used to allocate their patients over treatment arms. results: gps preferred allocation to the intervention (vas . (sd . ); - : indicates strongly favoring the intervention arm). after recruitment % of gps estimated a randomization ratio of : was used. the participants showed no relevant differences at baseline. conclusion and discussion: gps profoundly preferred allocation to the intervention group. few indications of allocation disclosure or selection bias were found in the dutch easycare trial. pseudo cluster randomization proofs to be a valid randomization method. abstract background: epidemiological studies rely on self-reporting to acquire data on participants, although such data are often limited in reliability. the aim here is to assess nuclear magnetic resonance (nmr) based metabonomics for evaluation of self-reported data on paracetamol use. method: four in-depth -hour dietary recalls and two timed -hour urine collections were obtained for each participant in the intermap study. a mhz h nmr spectrum was acquired for each urine specimen (n = , ). training and test sets involved two strata, i.e., paracetamol metabolites yes or no in the urine spectra, selected from all population samples by a principal component analysis model. the partial least squares-discriminant analysis (pls-da) model based on a training set of samples was validated by test set (n = ). the model correctly predicted stratum for of samples ( %) after removal of outliers not fitting the model, sensitivity . %, specificity %. this model was used to predict paracetamol status in all intermap specimens. it identified participants ( . %) who underreported analgesic use, of whom underreported analgesic use in both clinical visits. conclusion: nmr-based metabonomics can be used as a tool to enhance reliability of self-reported data. abstract background: in patients with asthma, the decline in forced expiratory volume in one second (fev ) is accelerated compared with non-asthmatics. objective: to investigate long-term prognostic factors of fev change in asthmatics from the general population. methods: a cohort of asthmatics ( - years-old) was identified in the frame of the european community respiratory health survey ( / ), and followed up in / . spirometry was performed on both occasions. the annual fev decrease (?fev ) was analysed by multi-level regression models, according to age, sex, height, bmi, occupation, familiarity of asthma, hospitalization for asthma (baseline factors); cumulative time of inhaled corticosteroid (ics) use and annual weight gain during the follow-up; lifetime pack-years smoked. results: when adjusting for all covariates, ics use for > years significantly reduced ?fev , with respect to non-users, of . ( %ci: . - . ) ml/year. ?fev was . ( . - . ) ml/year lower in women than in men. it increased by . ( . - . ) ml/year for every additional year in patient age and by . ( . - . ) ml/year for every additional kg/year in the rate of weight gain. conclusion: long-term ics use (> years) seems to be associated with a reduced ?fev over a -year followup. body weight gain seems a crucial factor in determining lung function decrease in asthmatics. abstract background: effectiveness of screening can be predicted by episode sensitivity, which is estimated by interval cancers following a screen. full-field digital or cr plate mammography are increasingly introduced into mammography screening. objectives: to develop a design to compare performance and validity between screen-film and digital mammography in a breast cancer screening program. methods: interval cancer incidence was estimated by linking screening visits from - at an individual level to the files of the cancer registry in finland. these data were used to estimate the study size requirements for analyzing differences in episode sensitivity between screen-film and digital mammography in a randomized setting. results: the two-year cumulative incidence of interval cancers per screening visits was estimated to be . to allow the maximum acceptable difference in the episode sensitivity between screen-film and digital arm to be % ( % power, . significance level, : randomization ratio, % attendance rate), approximately women need to be invited. conclusion: only fairly large differences in the episode sensitivity can be explored within a single randomized study. in order to reduce the degree of non-inferiority between the screen-film and digital mammography, meta-analyses or pooled analyses with other randomized data are needed. according to the literature up to % of colorectal cancers worldwide is preventable by dietary change. however the results of the epidemiologic studies are not consistent across the countries. the objective of the study is to evaluate the role of dietary nutrients on colorectal cancer risk in poland. the hospital-based case-control study was carried out in - . in total, histologically confirmed cancer cases and controls were recruited. adjustment for age, sex, education, marital status, multivitamin use, alcohol consumption, cigarette smoking, family history and energy consumption was done by logistic regression model. low tertile of daily intake in the control group was defined as a reference level. the lower colorectal cancer risk was found in cases with high daily intake of dietary fiber (or = , ; %ci: , - , ) and vitamin e (or = , ; %ci: , - , ). on the other hand, an increased risk for high monosaccharides consumption was observed. the risk pattern wasn't changed after additional adjustment for physical activity and body mass index. the results of the present study support the protective role of dietary fiber and some antyoxidative vitamins in the etiology of colorectal cancer. additionally they suggest that high consumption of monosaccharides may lead to elevated risk of investigated cancers. abstract assessment of nutrition is very difficult in every population, but in children there's additional question if child can properly recognize and recall foods that have been eaten. the aim of this study was to assess if dietary recall administered to adolescents can be used in epidemiological studies on nutrition. subjects were children, - years old, and they caretakers. -h recall was used to evaluate children's nutrition. both, child and caretaker were asked to recall all products, drinks and dishes eaten by child during the day before recall. the statistical analyses were done separately for each meal. we have noticed statistically significant differenced for intake of energy and almost all nutrients from the lunch. the observed spearman rank correlation coefficients between child and his caretaker ranged from . for vitamin c up to . for intake of carbohydrates. only calcium intake ( . vs. . mg/day) differentiated groups for the breakfast and b-carotene for the supper. the study showed that the recall with adolescents could be helpful source of data for the research in the population aspect. however, one shouldn't use such data for the examination of the individual nutritional habit of children, especially information about dinner can be biased. abstract background: acute bronchitis is one of the most common diagnoses made by primary care physicians. in addition to antibiotics, chinese medicinal herbs may be a potential medicine of choice. objectives: this review aims to summarize the existing evidence of comparative effectiveness and safety of chinese medicinal herbs for treating uncomplicated acute bronchitis. methods: we searched the cochrane central register of controlled trials, medline, embase, chinese biomedical database and etc. we included randomised controlled trials comparing chinese medicinal herbs with placebo, antibiotics or other western medicine for treating uncomplicated acute bronchitis. at least two authors extracted data and assessed trial quality. main results: four trials reported the time to improvement of cough, fever, and rales; two trials reported the proportion of patients with improved signs and symptoms; thirteen trials analyzed the data of global assessments of improvement. one trial reported the adverse effect during treatment. conclusions: there is insufficient quality data to recommend the routine use of chinese herbs for acute bronchitis. the benefit found in individual studies and this systematic review could be due to publication bias and study design limitations. in addition, the safety of chinese herbs is unknown, though adverse events are rarely reported. design and methods: patients with a definite ms and classified as dead or alive at st january were included in this retrospective observational study. influence of demographic and clinical variables was assessed with kaplan meier and cox methods. standardised mortality ratios were computed to compare patients' mortality with the french general population. results: a total of patients were included ( men, women). the mean age at ms onset was +/) years and the mean follow-up duration was +/) years ( patients-years). by , deaths occurred ( per patients-years). male gender, progressive course, polysymptomatic onset and high relapse rate were related to a worse prognosis. ms did not increase the number of deaths in our cohort compared to the general french population ( expected), except for highly disabled patients ( observed, expected). conclusion: this study gave precise insights on mortality in multiple sclerosis in west france. mattress dust. methods: we performed nested case-control studies within ongoing birth cohort studies in germany, the netherlands, and sweden and selected approximately sensitised and non-sensitised children per country. we measured levels of bacterial endotoxin, ß( -> )-glucans, and fungal extracellular polysaccharides (eps) in dust samples collected on the children's mattresses. results: combined across countries, higher amounts of dust and higher endotoxin, ß( -> )-glucans, and eps loads of mattress dust were associated with a significantly decreased risk of sensitization to inhalant allergens, but not food allergens. after mutual adjustment, only the protective effect of the amount of mattress dust remained significant [odds ratio ( % confidence interval) . ( . - . )]. conclusion: higher amounts of mattress dust might decrease the risk of allergic sensitization to inhalant allergens. the effect might be partly attributable to endotoxin, ß( -> )-glucans, and eps. it is not possible to distinguish with certainty, which component relates to the effect, since microbial agents loads are highly correlated with amount of dust and with each other. abstract background: postmenopausal hormone therapy (ht) increases mammographic density, a strong breast cancer risk factor, but effects vary across women. objective: to investigate whether the effect of ht use on changes in mammographic density is modified by polymorphisms in the estrogen (esr ) and progesterone receptor (pgr) genes. design and methods: information on ht use, dna and two consecutive mammograms were obtained from ht users and never ht users of the dutch prospect-epic and the english epic-norfolk cohorts. mammographic density was assessed using a computer-assisted method. changes in density between mammograms before and during ht use were analyzed using linear regression. results: a difference in percent density change between ht users and never users was seen in women with the esr pvuii pp or pp genotype ( . %; p< . ), but not in those with the pp genotype ( . %; p = . ). similar effects were observed for the esr xbai and the pgr + g/a polymorphisms. the pgr progins polymorphism did not appear to make women more susceptible to the effects of ht use. discussion and conclusion: our results suggest that specific polymorphisms in the esr and pgr genes may make women more susceptible to the effects of ht use on mammographic density. abstract background: there is a paucity of data on the cancer risk of turkish migrant children in germany. objectives: to identify cancer cases of turkish origin in the german childhood cancer registry (gccr) and to compare the relative incidence of individual cancers among turkish and non-turkish children. design and methods: we used a name algorithm to identify children of turkish origin among the , cancer cases below years of age registered since . we calculated proportional cancer incidence ratios (pcir) stratified for sex and time period. results: the name algorithm performed well (high sensitivity and specificity), and turkish childhood cancers were identified. overall, the relative frequency of tumours among turkish and non-turkish children is similar. there are specific sites and cancers for which pcirs are different; these will be reported during the conference. conclusion: our study is the first to show differences in the relative frequency of cancers among turkish and non-turkish children in germany. discussion: case control studies could help to explain whether observed differences in the relative frequency of cancers are due to differences in genetic disposition, lifestyle or socio-economic status. mutations in the netherlands cohort study on diet and cancer. data from , participants, cases and , subcohort members were analysed from a follow-up period between . to . years after baseline. adjusted gender-specific incidence rate ratios (rr) and % confidence intervals (ci) were calculated over tertiles of folate intake in case-cohort analyses. high folate intake did not reduce overall colon cancer risk. however, in men only, it was inversely associated with apc[csymbol] colon tumours (rr . , % ci . - . for the highest versus the lowest tertile of folate intake), but positively associated with apc+ colon tumours (highest vs. lowest tertile: rr . , ci . - . ). folate intake was neither associated with overall rectum cancer risk, nor with rectum cancer when apc mutation status was accounted for. we observed opposite associations between folate intake and colon cancer risk with or without apc mutations in men, which may implicate a distinct mutated apc pathway mediated by folate intake in men. abstract background and objectives: ten years after completion of the first serum bank of the general population to evaluate the long-term effects of the national immunisation programme (nip) a new serum collection is desirable. the objective is to provide insight into age-specific estimates of the immunity to childhood diseases and estimates of the incidence of infectious diseases with a frequent sub clinical course. design and methods: a two-stage cluster sampling technique was used to draw a nationwide sample. in each of five geographic regions, eight municipalities were randomly selected proportionally to their size. within each municipality, an age-stratified sample of individuals ( - yr) will be drawn from the population register. in addition eight municipalities will be selected with lower immunization coverage to obtain insight into the immune status of persons who often refuse vaccination on religious grounds. furthermore over sampling of migrants will be performed to study whether their immune status is satisfactory. participants will be asked to fill in a questionnaire and to allow blood to be taken. extra blood will be taken for a genetic study. results and conclusion: the design of a population-based serum collection aimed at the establishment of a representative serum bank will be presented. abstract background: during the last decade, the standard of diabetes care evolved to require more intensive management focussing on multiple cardiovascular risk factors. treatment decisions for lipidlowering drugs should be based on cholesterol and blood pressure levels. objectives: to investigate the influence of hba c, blood pressure and cholesterol levels on subsequent intensification of lipid-lowering therapy between - . design and methods: we conducted a prospective cohort study including , type diabetes patients who had at least two consecutive annual visits to a diabetes nurse. treatment intensification was measured by comparing drug regimes per year, and defined as initiation of a new drug class or dose increase of an existing drug. results: between - , the prevalence of lipid-lowering drug use increased from % to %. rates of intensification of lipid-lowering therapy remained low in poorly controlled patients ( % to %;tc/hdl ratio> ). intensification of lipid-lowering therapy was only associated with tc/hdl ratio (age-adjusted or = . ; %ci . - . ) and this association became slightly stronger over time. blood pressure was not found to be a predictor of the intensification of lipid-lowering therapy (or = . ). conclusion: hypercholesterolemia management intensified between - , but therapy intensification was only triggered by elevated cholesterol levels. more attention for multifactorial risk assessment is needed. abstract background: there are no standard severity measures that can classify the range of illness and disease seen in general practice. objectives: to validate new scales of morbidity severity against age, gender, deprivation and poor physical function. design and methods: in a cross-sectional design, morbidity data for consulters in a -month period was linked to their physical function status . there were english older consulters ( years +) and dutch consulters ( years +). consulters for morbidities classified on four gp-defined ordinal scales of severity ('chronicity', 'time course', 'health care use' and 'patient impact on activities of daily living') were compared to consulters for morbidity other than the , by age-groups, gender, and dichotomised deprivation and physical function scores. results: for both countries, on all scales, there was an increasing association between morbidity severity and older ages, female gender, more deprivation (minimum p< . ) and poor physical function (all trends p< . ). the estimates for categories, for example, within the 'chronicity' scale was ordered as follows: 'acute' (unadjusted odds ratio . ), 'acute-on-chronic' ( . ), 'chronic' ( . ) and 'life-threatening' ( . ). conclusions: new validated measures of morbidity severity indicate physical health status and offer the potential to optimise general practice care. hospitalization or death. calibration and discriminative capacity were estimated. results: among episodes of lrti in elderly patients with dm, endpoints occurred (attack rate %). reliability of the model was good (goodness-of-fit test p = . ). the discriminative properties of the original rule was acceptable (area under the receiver-operating curve (auc): . , % ci: . to . ). conclusion: the prediction rule for the probability of hospitalization or death derived from an unselected elderly population with lrti appeared to have acceptable discriminative properties in diabetes patients and can be used to target management of these common diseases. confounding by indication is a major threat to the validity of nonrandomized studies on treatment effects. we quantified such confounding in a cohort study on the effect of statin therapy on acute respiratory disease (ard) during influenza epidemics in the umc utrecht general practitioner research database among persons aged > = years. the primary endpoint was a composite of pneumonia or prednisolone-treated ard during epidemic, non-epidemic and summer seasons. to quantify confounding, we obtained unadjusted and adjusted estimates of associations for outcome and control events. in all, , persons provided , persons-periods, statin therapy was used in . % and in , person-periods an outcome event occurred. without adjustments, statin therapy was not associated with the primary endpoint during influenza epidemics (relative risk [rr] . ; % confidence interval [ %ci]: . - . ). after applying multivariable generalized estimating equations (gee) and propensity score analysis the rrs were . ( % ci: . - . ) and . ( % ci: . - . ). the findings were consistent across relevant strata. in non-epidemic influenza and summer seasons the rr approached . while statin therapy was not associated with control event rates. observed confounding in the association between statin therapy and acute respiratory outcomes during influenza epidemics masked a potential benefit of more than %. abstract background: despite several advances in the treatment of schizophrenia, the currently available pharmacotherapy does not change the course of illness or prevent functional deterioration in a substantial number of patients. therefore, research efforts into alternative or adjuvant treatment options are needed. in this project, called the 'aspirine trial', we investigate the effect of the antiinflammatory drug acetylsalicylic acid as an add-on to regular antipsychotic therapy on the symptoms of schizophrenia. objectives: to objective is to study the efficacy of acetylsalicylic acid in schizophrenia on positive and negative psychotic symptoms, immune parameters and cognitive functions. design and methods: a randomized placebo controlled double-blind add-on trial of inpatients and outpatients with schizophrenia, schizophreniform or schizoaffective disorder is performed. patients are : randomized to either months mg acetylsalicylic acid per day or months placebo, in addition to their regular antipsychotic treatment. all patients receive pantoprazole treatment for gastroprotection. participants are recruited from various major psychiatric hospitals in the netherlands. the outcomes of this study are -month change in psychotic and negative symptom severity, cognitive function, and several immunological parameters. status around participants have been randomized. no interim analysis was planned. abstract background: congenital cmv infection is the most prevalent congenital infection worldwide. epidemiology and outcome are known to vary with socio-economic background, but few data are available on epidemiology and outcome in a developing country, where the overall burden of infectious diseases is high. objective: to determine prevalence, riskfactors and outcome of congenital cmv infection in an environment with high infectious disease burden methods: as part of an ongoing birth cohort study, baby and maternal samples were collected at birth, and tested with an inhouse pcr for the presence of cmv. standardised clinical assessment were performed by a paediatrician. placental malaria was also assessed. follow-up is ongoing till the age of years. preliminary results: the prevalence of congenital cmv infection was / ( . %). the infected children were more often first born babies ( . % vs . %, p< . ). while no seasonality was observed, placental malaria was more prevalent among congenitally infected children ( . % vs . %,p = . ). there were no symptomatic babies detected. conclusion: this prevalence of congenital cmv is much higher than reported in industrialised countries, in the absence of obvious clinical pathology. further follow up is needed to assess impact on response to vaccinations, growth, and morbidities. of wheeze or cough at night in the first years. data on respiratory symptoms and dda were collected by yearly questionnaires. in total, symptomatic children with and without an early dda were included in the study population. results: fifty-one percent of the children with and % of the children without an early dda had persistent respiratory symptoms at age . persistence of symptoms was associated with parental atopy, eczema, nose symptoms without a cold, or a combination of wheeze and cough in the first years. conclusions: monitoring the course of symptoms in children with risk factors for persistent symptoms, irrespective of a diagnosis of asthma, may contribute to early recognition and treatment of asthma. little is known about the response mechanisms of survivors of disasters. objective: to examine selective non-response and to investigate whether attrition has biased the prevalence estimates among survivors of a disaster. design and methods: a longitudinal study was performed after the explosion of a fireworks depot in enschede, the netherlands. survivors completed a questionnaire weeks (t ), months (t ) and years post-disaster (t ). prevalence estimates resulting from multiple imputation were compared with estimates resulting from complete case analysis. results: non-response differed between native dutch and nonwestern immigrant survivors. for example, native dutch survivors who participate at t only were more likely to have health problems at t such as depression than native dutch who participated at all three waves (or = . , % ci: . - . ) . in contrast, immigrants who participated at t only were less likely to have depression at t (or = . , % ci: . - . ). conclusion and discussion: among native dutch survivors, the imputed estimates of t health problems tended to underestimated than the complete case estimates. the imputed t estimates among immigrants were unaffected or somewhat overestimated than the complete case estimates. multiple imputation is a useful statistical technique to examine whether selective non-response has biased the prevalence estimates. session: posters session : july presentation: poster. background: several epidemiologic studies have shown decreased colon cancer risk in physically active individuals. objectives: this review provides an update of the epidemiologic evidence for the association between physical activity and colon cancer risk. we also explored whether study quality explains discrepancies in results between different studies. methods: we included cohort (male n = ; female n = ) and case-control studies (male n = ; female n = ) that assessed total or leisure time activities in relation to colon cancer risk. we developed a specific methodological quality scoring system for this review. due to the large heterogeneity between studies, we refrained from statistical pooling. results: in males, the cohort and case-control studies lead to different conclusions: the case-control studies provide strong evidence for a decreased colon cancer risk in the physically active while the evidence in the cohort studies is inconclusive. these discrepant findings can be attributed to either misclassification bias in cohort or selection bias in case-control studies. in females, the small number of high quality cohort studies precludes a conclusion and the case-control studies indicate an inverse association. conclusion: this review indicates a possible association of physical activity and reduction of colon cancer risk in both sexes but the evidence is not yet convincing. abstract background/objectives: radiotherapy after lumpectomy is commonly applied to reduce recurrence of breast cancer but may cause acute and late side effects. we determined predictive factors for the development of late toxicity in a prospective study of breast cancer patients. methods: late toxicity was assessed using the rtog/ eortc classification among women receiving radiotherapy following lumpectomy after a mean follow-up time of months. predictors of late toxicity were modelled using cox regression in relation to observation time, adjusting for age, bmi and biologically effective dose in the maximum at the skin. results: ( . %) patients presented with telangiectasia and ( . %) patients with fibrosis. we observed a strong association between development of telangiectasia and fibrosis (p< . ). increasing patient age was a risk factor for telangiectasia and fibrosis (p for trend . and . , respectively). boost therapy (hazard ratio (hr) . , % ci . - . ) and acute skin toxicity (hr . , % ci . - . ) significantly increased risk of telangiectasia. risk of fibrosis was elevated among patients with atopic diseases (hr . , % ci . - . ). discussion: our study revealed several risk factors for late complications of radiotherapy. further understanding of differences in response to irradiation may enable individualized treatment and improve cosmetic outcome. doctor-diagnosed asthma and respiratory symptoms (age ) were available for (rint) and (no) children. results: the discriminative capacities of rint and exhaled no were statistically significant for the prediction of doctor-diagnosed asthma, wheeze (rint only) and shortness of breath (rint only). due to the low prevalence of disease in this general population sample, the positive predictive values of both individual tests were low. however, the positive predictive value of the combination of increased rint (cutoff . kpa.l- .second) and exhaled no (cut-off ppb) was % for the prediction of doctor-diagnosed asthma, with a negative predictive value of %. combinations of rint or exhaled no with atopy of the child showed similar results. conclusions: the combination of rint, exhaled no and atopy may be useful to identify high-risk children, for monitoring the course of their symptoms and to facilitate early detection of asthma. abstract background: in a cargo aircraft crashed into apartment buildings in amsterdam, killing people, and destroying apartments. an extensive, troublesome aftermath followed with rumours on toxic exposures and health consequences. objectives: we studied the long-term physical health effects of occupational exposure to this disaster among professional assistance workers. design and methods: in this historical cohort study we compared the firefighters and police officers who were occupationally exposed to this disaster (i.e. who reported one or more disasterrelated tasks) with their nonexposed colleagues (n = , and n = , respectively), using regression models adjusted for background characteristics. data collection took place from january to march , and included various clinical blood and urine parameters (including blood count and kidney function), and questionnaire data on occupational exposure, physical symptoms, and background characteristics. the overall response rate was %. results: exposed workers reported various physical symptoms (including fatigue, skin and musculoskeletal symptoms) significantly more often than their nonexposed colleagues. in contrast, no consistent significant differences between exposed and nonexposed workers were found regarding clinical blood and urine parameters. discussion and conclusion: this epidemiological study demonstrates that professional assistance workers involved in a disaster are at risk for long-term unexplained physical symptoms. abstract background and objectives: recent studies indicate that women with cosmetic breast implants have significantly increased risk of suicide. reasons for elevated risk are not known. it is suggested that women with cosmetic breast implants differ in their characteristics and have more mental problems than women of general population. aim of this study was to find out possible associations between physical or mental health and postoperative quality of life among finnish women with cosmetic breast implants. design and methods: information was collected from patient records of women and structured questionnaires mailed to women of the same cohort. data was analysed by using pearson chi square testing and logistic regression modelling. results: although effects of implantation on postoperative quality of life in different areas were mainly reported as positive or neutral, % of the women reported decreased state of health. postoperative dissatisfaction and decreased quality of life were significantly associated with diagnoses of depression (p = . ) and local complication called capsular contracture (p< . ). conclusion: our results are consistent with previous results finding most of the cosmetic breast surgery patients satisfied after implantation. however, this study brings new information on associations between depression, capsular contracture and decreased quality of life. abstract cancer and its treatments often produce significant persistent morbidities that reduce quality of life (qol) in cancer survivors. research indicates that both, physical exercise and psycho-education might enhance qol. therefore, we developed a -week multidisciplinary rehabilitation program that combines physical training with psycho-education. the aim of the present multicenter study is to determine the effect of multidisciplinary rehabilitation on qol as compared to no treatment and, additionally, to physical training alone. furthermore, we will explore which variables are related to successful outcome (socio-demographic, disease related, physiological, psychological and environmental characteristics). participants are needed to detect a medium effect. at present, cancer survivors are randomised to either the multidisciplinary or physical rehabilitation program or a -month waiting list control group. outcome assessment will take place before, halfway, directly after, and months following the intervention by means of questionnaires. physical activity will be measured before, halfway and directly after rehabilitation using maximal and submaximal cycle ergometer testing and muscle strength measurement. effectiveness of multidisciplinary rehabilitation will be determined by analysing changes between groups from baseline to post-intervention using multiple linear and logistic regression. positive evaluation of multidisciplinary rehabilitation may lead to implementation in usual care. continuous event recorders (cer) have proven to be successful in diagnosing causes of palpitations but may affect patient qol and increase anxiety. objectives: determine qol and anxiety in patients presenting with palpitations, and to evaluate the burden of the cer on qol and anxiety in patients presenting to the general practitioner. methods: randomized clinical trial in general practice. the short form- (sf- ) and state-trait anxiety inventory (stai) were administered at study inclusion, -weeks and months. results: at baseline, patients with palpitations (n = ) reported lower qol and more anxiety than a healthy population for both males and females. there were no differences between the cer arm and usual gp care at -weeks. at -months the usual care group (n = ) showed minimal qol improvement and less anxiety compared to the cer group (n = ). type of diagnosis did not account for any of these reported differences. conclusion: anxiety decreases and qol increases in both groups at -weeks and -month follow-up. hence it is a safe and effective diagnostic tool, which is applicable for all patients with palpitations in the general practice. abstract background: clinical benefits of statin therapy are accepted, but their safety profiles have been under scrutiny, particularly for the most recently introduced statin, rosuvastatin, relating to serious adverse events involving muscle, kidney and liver. objective: to study the association between statin use and the incidence of hospitalizations for rhabdomyolysis, myopathy, acute renal failure and hepatic impairment (outcome events) in real life. methods: in and , , incident rosuvastatin users, , incident other statin users and , patients without statin prescriptions from the pharmo database of > million dutch residents were included in a retrospective cohort study. potential cases of hospitalization for myopathy, rhabdomyolysis, acute renal failure or hepatic impairment were identified using icd- -cm codes and validated using hospital records. results: there were validated outcome events in the three cohorts including one case each of myopathy (other statin group) and rhabdomyolysis (non-treated group). there were no significant differences in the incidence of outcome events between rosuvastatin and other statin users. discussion: this study indicated that the number of outcome events is less than per person years. rosuvastatin does not lead to an increased incidence of rhabdomyolysis, myopathy, acute renal failure and hepatic impairment compared to other statins. the aim: the aim of the study was to assess the influence of insulin resistance (ir) on the coronary artery disease (cad) occurrence in middle aged women with normal glucose tolerance (ngt) material and methods: in - year women aged - , participants of the polish multicenter study on diabetes epidemiology were examined. anthropometric, biochemical (fasting lipids, fasting and after glucose load plasma glucose and insulin) and blood pressure determinations were performed . ir was defined as the matsuda index (irmatsuda) below the lower quartile of the irmatsuda distribution in ngt population the questionnaire examination of the lifestyle, present and past diseases was performed. results: ir was observed in % of all examined women and in . % with ngt. cad was diagnosed in , % of all examined women and in , % of those with ngt. the relative risk of cad related to ir in ngt and normotensive women was , ( % ci: , - , ) (p< . ). regular menstruation was observed in , % of cad women. irmatsuda was not different for cad menstruating and non menstruating women (respectively , ± , and , ± , ). conclusion: in middle aged, normotensive and normal glucose tolerant women ir seems to be an important risk factor of cad abstract background: in germany, primary prevention at population level is provided by general practitioners (gp). little is known about gps' strategies to identify patients at high risk for vascular diseases using standardised risk scores. objectives: we studied gp attitudes and current practice in using risk scores. methods-a cross-sectional survey was conducted among gps in north rhine-westphalia, germany, using mailed self-administered questionnaires on attitudes and current practice in identification of patients at high risk for vascular diseases. results: in , gps participated in the study. . % of gps stated to know the framingham-score, . % the procam-score and . % the score-score. . % of gps reported regular use of standardised risk scores to identify patients at high risk for vascular diseases, most frequently procam-score ( . %), followed by score-score ( . %) and framingham-score ( . %). main reasons for not using standardised risk scores were assumed rigid assessment of individual patients' risk profile ( . %), time-consuming appliance ( . %) and higher confidence in own work experience ( . %). conclusion: use of standardised risk scores to identify patients at high risk for vascular diseases is common among gps in germany. however, more educational work might be useful to strengthen gps' belief in the flexible appliance of standardised risk scores in medical practice. among epilepsy patients than in general population, but effects of specific antiepileptic drugs on birth rate are not well known. objectives: to estimate birth rate in epilepsy patients on aed treatment or without aeds and in a population-based reference cohort without epilepsy. design and methods: patients (n = , ) with reimbursement for aeds for the first time between and and information on their aed use, were identified from the databases of social insurance institution of finland. reference cohort without epilepsy (n = , ) and information on live births were identified from the finnish population register centre. the analyses were performed using poisson regression modelling. results:birth rate was decreased in epilepsy patients in relation to reference cohort without epilepsy in both genders regardless of aed use. in relation to untreated patients, women on any of the aeds had non-significantly lower birth rates. among men, birth rate was decreased in men on oxcarbazepine (rr = . , % ci = . , . ), but was not clearly lower among those on carbamazepine (rr = . , % ci = . , . ) or valproate (rr = . , % ci = . , . ) when compared to untreated patients. conclusion: our results suggest that birth rate is decreased among epilepsy patients on aeds, more so in men. abstract background: hereditary hemochromatosis (hh), characterised by excessive iron absorption, subsequent iron storage and progressive clinical features, can when diagnosed at an early stage be successfully treated. high prevalence of the c y-mutation on the hfe-gene in the hh patient population may motivate genetic screening. objectives: in first-degree relatives of c y-homozygotes we studied the gender and age -related biochemical penetrance of hfe-genotype to define a high-risk population eligible for screening. design and methods: one-thousand-six first-degree family members of probands with clinically overt hfe-related hh from five medical centres in the netherlands were approached. data on levels of serum iron parameters and hfe-genotype were collected. elevation of serum ferritin was defined using the centre-specific normal-values by age and gender. results: among the participating relatives, highest serum iron parameters were found in male c y-homozygous siblings aged > years: % had elevated levels of serum ferritin. generally, male gender and increased age are related with higher iron values. discussion and conclusion: genetic screening for hh is most relevant in male and elderly first-degree relatives of patients with clinically overt hfe-related hh, enabling regular investigations of iron parameters in homozygous individuals. abstract background: nosocomial infection causes increased hospital morbidity and mortality rates. although handwashing is known to be the most important action in its prevention, adherence of health care workers to recommended hand hygiene procedures is extremely poor. objective: evaluation of compliance of hand hygiene recommendations in health care workers of a tertiary hospital in barcelona after a course on hand hygiene was given to all nurses in the hospital during the previous year. methods: by means of nondeclared observation, compliance (handwashing or disinfecting, not solely glove exchange) of recommendations given by the center for disease control related to opportunities for hand hygiene was registered, in procedures of diverse risk level for infection, both in physicians and nurses. results: in opportunities for hand hygiene carried out by health care workers compliance of recommendations was . %. adherence differed between wards ( . % in intensive care units, . % in medical wards and . % in surgical wards) and slightly between health care workers ( . % in physicians, . % in nurses). discussion: in conclusion, after one year of an intervention on education, adherence to hand hygiene recommendations is very low. these results enhance the need of reconsidering the type of interventions implemented. type of comorbidity affects qol most. objectives: we studied whether qol differed in subjects with dm with and without comorbidities. in addition, we determined differences in type of comorbidity. design and methods: cross-sectional data of dm patients, participants of a population-based dutch monitoring project on risk factors for chronic disease (morgen) were analyzed. qol was measured by the short form . we compared the means of subdimensions for dm patients with one comorbidity (cardiovascular diseases (cvd), musculoskeletal diseases (msd) and asthma/copd) to dm patients without this comorbidity, by regression analyses adjusted for age and sex. results: the prevalences of cvd, msd and asthma/copd were . %, . %, and . %. all comorbidities were associated with lower qol, especially for physical functioning. the mean difference ( % ci) was . abstract background: the extent or increase of ueds is suggested repeatedly, but never before the scientific literature was systematic studied. objectives: a systematic appraisal of the worldwide incidence and prevalence rates of upper extremity disorders (ueds) available in scientific literature was executed to gauge the range of these estimates in various countries and to determine whether the rates are increasing in time. design and methods: studies that recruited at least people, collected data by using questionnaires, interviews and/or physical examinations, and reported incidence or prevalence rates of the whole upper-extremity including neck, were included. results: no studies were found with regard to the incidence of ueds and studies that reported prevalence rates of ueds were included. the point prevalence ranged from . - %; the months prevalence ranged from . - %. one study reported on the lifetime prevalence ( %). we did not find evidence of a clear increasing or decreasing pattern over time. it was not possible to pool the date, because the definitions used for ueds differed enormously. conclusions: there are substantial differences in reported prevalence rates on ueds. main reason for this is the absence of a universally accepted way of labelling or defining ueds. abstract background: the absolute number of women diagnosed with breast cancer increased from , in to , in in the netherlands. likewise, the age standardized rate increased from . to . per , women. besides the current screening programme, changes in risk profile could be a reason for the increased incidence. objective: we studied the changes in breast cancer risk factors for women in nijmegen. methods: in the regional screening programme in nijmegen, almost , women aged - years filled in a questionnaire about risk factors in [ ] [ ] . similar questions were applied in the nijmegen biomedical study in , where women of - year participated. the median age in both studies was years. results: the frequency of a first-degree relative with breast cancer was . % and . % in and , respectively . none of the other risk factors, as the age of women at st birth ( . % respectively . %), nulliparity ( . % resp. . %), age at menarche ( . % resp. . %), age at menopause ( . % resp. . %) and obesity ( . % resp. . %), changed in time. conclusion: the distribution of risk factors hardly changed, and is unlikely to explain the rise in breast cancer incidence from onwards. abstract background: a single electronic clinical history system has been developed in the bac (basque autonomous community) for general use for all health centres, thus making it possible to collect information online on acute health problems as well as chronic ailments. method: the prevalence of diabetes, high blood pressure and copd (chronic obstructive pulmonary disease) was estimated using icd- -cm diagnosis performed by primary care physicians. an estimate was also made of the prevalence of cholesterolemia based on the results of analyses requested by physicians. results: in , , patients (out of a total population of , , ) were assessed for serum cholesterol levels. based on this highly representative sample, it was estimated that . % had serum cholesterol levels above mg/dl. the prevalence of diabetes mellitus in people over the age of was . %. the prevalence of high blood pressure in people over was %. discussion: the primary care database makes it possible to access information on problems related to chronic illnesses. knowing the prevalence of diabetes patients enables doctors to analyse all aspects related to services used by the diabetic population. it also makes it possible to monitor analytical data in real time and evaluate health service outcomes. examinations were used to asses risk factors for diabetes. cases (n = ) were matched on age and sex to controls (n = ) who were not treated with antidiabetic drugs. logistic regression was used to calculate odds ratios (or). results: the or of incident diabetes for acei-use versus non-acei use was . ( %ci : . - . ). for ace dd homozygotes the or was . ( %ci: . - . ) and for ace-i allele carriers . ( %ci: . - . ). the interaction or was . ( %ci: . - . ). the agt and at r genotypes did not modify the association between acei use and diabetes. abstract background: lignans have antioxidant and estrogen-like activity, and may therefore lower cardiovascular and cancer risk. objective: we have investigated whether intake of four plant lignans (lariciresinol, pinoresinol, secoisolariciresinol, matairesinol) was inversely associated with coronary heart disease (chd), cardiovascular diseases (cvd), cancer, and all-cause mortality. design: the zutphen elderly study is a prospective cohort study in which men aged - y were followed for years. lignan intake was estimated using a recently developed database, and related to mortality using cox proportional hazards analysis. results: median total lignan intake in was lg/d. beverages such as tea and wine, vegetables, bread, and fruits were the major lignan sources. total lignan intake was not related to mortality. however, matairesinol was inversely associated with chd, cvd, cancer, and all-cause mortality. multivariate adjusted rrs ( % ci) per sd increase in intake were . ( . - . ) for chd, . ( . - . ) for cvd, . ( . - . ) for cancer, and . ( . - . ) for allcause mortality. conclusions: total lignan intake was not associated with mortality. the intake of matairesinol was inversely associated with mortality from chd, cvd, cancer, and all-causes. we can not rule out that this is due to an associated factor, such as wine consumption. abstract despite the drastic increase in the amount of research into neighbourhood-level contextual effects on health, studies contrasting these effects between different domains of health within one contextual setting are strikingly sparse. in this study we use multilevel logistic regression models to estimate the existence of neighbourhood-level variations of physical health functioning (pcs) and mental well-being (ghq) in the helsinki metropolitan area and assess the causes of these differences. the individual-level data are based on a health-survey of - year old employees of the city of helsinki (n = , response rate %). the metropolitan area is divided into neighbourhoods, which are characterised using a number of area-level indicators (e.g. unemployment rate). our results show moderate but systematic negative effect of indicators of neighbourhood deprivation on physical functioning, whereas for mental health the effect is absent. these effects were strongest for proportion of manual workers; odds ratio for poor physical functioning was . for respondents living in areas with low proportion of manual workers. part of this effect was mediated by differences in health behaviour. analyses on cross-level interactions show that individual-level socioeconomic differences in physical health are smallest in most deprived areas, somewhat contradicting the results of earlier studies. abstract background: the second-eye cataract surgery is beneficial, nevertheless, there is a considerable proportion of unmet needs. objective: to estimate the proportion of second-eye cataract surgery in the public health system of catalonia, and explore differences in utilisation by patients' gender, age, and region of residence. methods: a total of , senile cataract surgeries performed between and were included. proportions observed were adjusted through independent logarithmic regression models for each study factor. results: the proportion of second-eye surgery showed an increasing trend (r . %) from . % ( % ci . ; . ) in november to . % ( % ci . ; . ) in december , and its projection to years was , % ( % ci . ; . ). the proportion of second-eye surgery was % ( % ci . ; . ) greater in women than in men. patients years or older had a lowest proportion ( . %; % ic . ; . ), which nevertheless increased during the period, unlike that of patients aged less than years. differences among regions were moderate and decreased throughout the period. conclusions: if the observed trends persist, there will be a substantial proportion of unmet need for bilateral surgery. we predict greater use of second-eye surgery by older patients. abstract background: persistence with bisphosphonates is suboptimal which could limit prevention of fractures in daily practice. objectives: to investigate the effect of long term persistent bisphosphonate usage on the risk of osteoporotic fractures. methods: the pharmo database, including drug-dispensing and hospital discharge records for > two million subjects in the netherlands, was used to identify new female bisphosphonate users > years from jan ' -jun ' . persistence with bisphosphonates was determined using the method of catalan. a nested matched case-control study was performed. cases had a first hospitalization for an osteoporotic fracture (index-date). controls were matched : to cases on year of inclusion and received a random index-date. the association with fracturerisk was assessed for one and two year persistent bisphosphonate use prior to the index-date. analyses were adjusted for di fferences in patient characteristics. results: , bisphosphonate users were identified and had a hospitalization for osteoporotic fracture during follow-up. one year persistent bisphosphonate use resulted in a % lower fracture rate (or . ; % ci . - . ) whereas two year persistent use resulted in a % lower rate (or . ; % ci . - . ). conclusion and discussion: these results emphasize the importance of persistent bisphosphonate usage to obtain maximal protective effect of treatment. abstract background: in the who recommended all countries to add hepatitis b (hbv) vaccination to their national immunization programs. the netherlands is a low hbv endemic country and therefore adopted a vaccination policy targeted towards high-risk groups. methods: during , epidemiological data and blood samples were collected from all reported patients with an acute hbv infection. a fragment of the s-gene was sequenced and phylogenetically analysed to clarify transmission patterns between risk groups. results: of hbv cases reported, % was infected through sexual contact ( % homo-/bisexual, % heterosexual). for patients samples were available for genotyping. phylogenetic analysis identified genotypes: a( %), b( %), c( %), d( %), e( %) and f( %). of men who have sex with men (msm), % were infected with genotype a. among heterosexuals, all genotypes were found. in many cases, genotypes b-f were direct or indirect related to countries abroad. only injecting drug user was found (genotype a). conclusion: genotype a is predominant in the netherlands, including most of the msm. migrant hbv carriers play an important role in the dutch hbv epidemic. genotyping provides insight into the spread of hbv among highrisk groups. this information will be used to evaluate the vaccination policy in the netherlands. abstract background: excess weight might affect the perception of both physical and mental health in women. objective: to examine the relationship between body mass index (bmi) and hrqol in women aged -to -year-old in a rural zone of galicia. design and methods: population-based cross-sectional study covering women, personally interviewed, from villages. hrqol was assessed with sf- questionnaire, through personal interviews. each scale of sf- was dichotomised in suboptimal or optimal hrqol using previously defined cut-offs. odds ratios (or) obtained from logistic regression summarize the relationship of bmi with each scale, adjusting for sociodemographic variables, sedentary leisuretime, number of chronic diseases and sleeping hours. results: a . % of women were obese (bmi = kg/m ) and . % overweight kg/m ) . frequency of suboptimal physical function was higher among overweight women (adjusted or: . ; % ci: . - . ) and obesity (adjusted or: . ; % ci: . - . ). furthermore, obese women had higher frequency of suboptimal scores on the general health scale (adjusted or: . ; % ci: . - . ). no differences were observed regarding mental health scores among women with different bmi categories. conclusion: in women from rural villages, overweight is associated with worse hrqol in physical function and general health. abstract background: pneumococcal vaccination among elderly is recommended in several western countries. objectives: we estimate the cost-effectiveness of a hypothetical vaccination campaign among the + general population in lazio region (italy). methods: a cohort was followed during a years timeframe. we estimated the incidence of invasive pneumococcal disease, in absence of vaccine, based on actual surveillance and hospital data. the avoided deaths and cases have been estimated from literature according to trial results. health expenditures included: costs of vaccine program, inpatient and some outpatient costs. cost-effectiveness was expressed as net healthcare costs per episode averted and life-year gained (lyg) and was estimated at baseline and in deterministic and stochastic sensitivity analyses. all parameters were age-specific and varied according to literature data. results: at baseline net costs per event averted and lyg at prices were, respectively, e , ( % ci: e , -e , ) and , ( % ci: e , -e , ). in the sensitivity analysis, bacteraemic pneumonia incidence and vaccine effectiveness increased the net cost per lyg by % and % in the worst-case scenario, and decreased it to e , in the best-case. conclusions: the intervention was not cost saving. the uncertainties concerning invasive pneumococcal disease incidence and vaccine effectiveness make the cost-effectiveness estimates instable. spain - abstract background: spatial data analysis can detect possible sources of heterogeneity in spatial distribution of incidence and mortality of diseases. moreover small area studies have greater capacity to detect local effects linked to environmental exposures. objective: to estimate the patterns of cancer mortality at municipal level in spain using smoothing techniques in a single spatial model. design and methods: cases were deaths due to cancer, registered at a municipal level nation-wide for the period - . expected cases for each town were calculated using overall spanish mortality rates and standard mortality ratios were computed. to plot the maps, smoothed municipal relative risks were calculated using besag york and mollie`model and markov chain monte carlo simulation methods. as an example maps for stomach and lung cancer neoplasms are shown. results: it was possible to obtain the posterior distribution of relative risk by a single spatial model including towns and the adjacencies. maps showed the singular patterns for both cancer locations. conclusion: the municipal atlas allows to avoid edge local effects, improving the detection of spatial patterns. discussion: bayesian modelling is a very efficient way to detect spatial heterogeneity by cancer and other causes of death. abstract background: little is known about the impact of socioeconomic status (ses) on outcomes of surgical care. objectives: we estimated the association between ses and outcomes of selected complex elective surgical procedures. methods: using hospital discharge registries (icd-ix-cm codes) of milan, bologna, turin and rome we identified patients undergoing cardiovascular operations (coronary artery bypass grafting, valve replacement, carotid endarterectomy, repair of unruptured thoracic aorta aneurysm) (n = , ) and cancer resections (pancreatectomy, oesophagectomy, liver resection, pneumonectomy, pelvic evisceration) (n = , ) in four italian cities, - . an area-based income index was calculated. post-operative mortality (in-hospital or within days) was the outcome. logistic regression adjusted for gender, age, residence, comorbidities, concurrent and previous surgeries. results: high income patients were older and had fewer comorbidities. mortality varied by surgery type (cabg , %, valve , %, endartectomy , %, aorta aneurysm , %, cancer . %). low income patients were more likely to die after cabg (or = . abstract background: an important medical problem of renal transplant patients who receive immunosuppression therapy, is the development of a malignancy during the long term follow-up. however, existing studies are not in agreement over whether patients who undergo renal transplantation have an increased risk of melanoma. objective: the aim of this study was to determine the incidence of melanoma in renal transplantation patients in the northern part of the netherlands. methods: we linked a cohort of patients who received a renal transplantation in the university medical centre groningen between and with the cancer registry of the comprehensive cancer centre north-netherlands, to identify all melanoma patients in this cohort. results: only patient developed a melanoma following the renal transplantation; no significant increase in the risk of melanoma was found. conclusion: although several epidemiologic studies have shown that the risk of melanoma is increased in renal transplantation patients who receive immunosuppression therapy to prevent allograft rejection, this increased risk was not found in the present study. the lower level of immunosuppressive agents given in the netherlands might be responsible for this low incidence. abstract background: socio-economic health inequalities are usually studied for self-reported income, although the validity of self-reports is uncertain. objectives: to compare self-reports of income by respondents to health surveys with their income according to tax registries, and determine to what extent choice of income measure influences the health-income relation. methods: around . respondents from the dutch permanent survey on living conditions were linked to data from dutch tax and housing registries of . both self-reported and registry-based measures of household equivalent income were calculated and divided into deciles. the association with less than good self-assessed health was studied using prevalence rates and odds ratios. results: around % of the respondents did not report their income. around % reported an income deciles lower or higher than the actual income value. the relation between income and health was influenced by choice of income measure. larger health inequalities were observed with selfreports compared to registry-based measures. while a linear healthincome relation was found using self-reported income, a curvilinear relation (with the worst health in the second lowest deciles) was observed for registry-based income. conclusion: choice of the income source has a major influence on the health-income relation that is found in inequality research. abstract background: while many health problems are known to affect immigrant groups more than the native dutch population, little is known about health differences within immigrant groups. objectives: to determine the association between self assessed health and socioeconomic status (ses) among people of turkish, moroccan, surinamese and antillean origin. methods: data were obtained from a social survey held among immigrants - years in the netherlands, with almost respondents per immigrant group. ses differences in the prevalence of 'poor' self-assessed health were measured using prevalence rate ratios estimated with regression techniques. results: within each immigrant group, poor health was much more common among those with low ses. the health of women was related to their educational level, occupational position, household income, financial situation and (to a lesser extent) their parents' education. similar relationships were observed for men, except that income was the strongest predictor of poor health. the health differences were about as large as those known for the native dutch population. conclusion and discussion: migrant groups are not homogenous. also within these groups, low ses is related to poor general health. in order to identify subgroups where most health problems occur, different socioeconomic indictors should be used. abstract background: genetic damage quantification can be considered as biomarker of exposure to genotoxic agents and as early-effect biomarker regarding cancer risk. objectives: to assess genetic damage in newborns and its relationship with anthropometrical, sociodemographic variables, maternal tobacco consumption and pollution perception. design and methods: the bio-madrid study recruited trios (mother/father/newborn) from areas in madrid to assess the impact of pollutants in humans. parents answered a questionnaire about socio-economic characteristics, pregnancy, life-style and perception of pollution. genetic damage in newborns were measured with the micronucleus(mn) test in peripheral lymphocytes poisson regression models were fitted using mn frequency per binucleated cells as dependent variable. explanatory variables included sex, parents age, tobacco, area and reported pollution level. results: the mean frequency of mn was . per (range: - ). no differences were found regarding area, sex and maternal tobacco consumption. mn frequency was higher in underweighted newborns and in those residing near heavy traffic roads. in recent years minimally invasive surgery procedures underwent rapid diffusion and laparoscopic cholecystectomy has been among the first to be introduced. after its advent, increasing rates of overall and laparoscopic cholecystectomy have been observed in many countries. we evaluated the effect of the introduction of laparoscopic procedure on the rates of cholecystectomy in friuli venezia giulia region, performing a retrospective study. from regional hospitals discharge data we selected all records with procedure code of laparoscopic (icd cm: ) or open ( ) cholecystectomy and diagnosis of uncomplicated cholelithiasis (icd cm: . ; . ; , ) or cholecystitis ( , ; , ), in any field, from to . in the year study period, the number of overall cholecystectomies increased from to (+ , %), mainly for the relevant increase of laparoscopic interventions from procedures, ( , % of overall cholecystectomies), to ( , %). rates of laparoscopic cholecystectomies increased from , to , per admitted patients with diagnosis of cholelithiasis or cholecystitis. the introduction of laparoscopic cholecystectomies was followed not only by a shift towards laparoscopically performed interventions but also by an increase in overall cholecystectomies in friuli venezia giulia region. abstract background: although a diminished doses scheme of -valent pneumococcal conjugate vaccination (pcv ) may offer protection against invasive pneumococcal disease, it might affect pneumococcal carriage and herd immunity. long term memory has to be evaluated. objective: to compare the influence of a and -doses pcv -vaccination scheme on pneumococcal carriage, transmission, herd immunity and anti-pneumococcal antibody levels. methods: in a prospective, randomized, controlled trial infants are randomly allocated to receive pcv at ages and months; ages , and months and the age of months only. nasopharyngeal (np) swabs are regularly obtained from infants and family members. the np swabs are cultured by conventional methods and pneumococcal serotypes are determined by quellung reaction. antibody levels are obtained at and months from infants in group i and ii and from infants in group iii. one thousand infants are needed to detect a % difference in pneumococcal carriage (a = . , ß = . ) between the three groups. results: so far, infants have been included. preliminary results show that prior to vaccination pneumococcal carriage was %. conclusion: this trial will provide insight into the effects of a diminished dose scheme on herd immunity and long-term antipneumococcal antibody development. abstract background: oil-spills cause important environmental damages and acute health problems on affected populations. objectives: to assess the impact of the prestige oil-spill in the hrqol of the exposed population. design and methods: we selected residents in coastal areas heavily affected by the oil-spill and residents in unaffected inland villages through random sampling, stratified by age and sex. hrqol was measured with the sf- questionnaire in personal interviews. individual exposure was also explored. mean differences in sf- scores > points were considered 'clinically relevant'. odds ratios (or) summarized the association between area of residence (coast vs inland) and suboptimum hrqol (lower than percentile th), adjusting for possible confounders. results: neither clinically relevant nor statistically significant differences were observed in most of the sf- scales regarding place of residence or individual exposure. worse scores (inland = , ; coast = , ; p< , ) abstract background: patient comorbidities are usually measured and controlled in health care outcome research. hypertension is one of the most commonly used comorbidity measures. objectives: this study aims to assess underreporting of hypertension in ami patients, and to analyze the impact of coding practices among italian regions or hospitals' type. methods: a cohort of ami hospitalisations in italy from november to october was selected. patients with a previous hospital admission reporting a diagnosis of complicated hypertension within the preceding months were studied. a logistic model was constructed. both crude and adjusted probability of reporting a hypertension in ami admissions, depending from the number of diagnosis fields compiled in discharge abstracts, and presence of other diseases were estimated. results: in . % of patients hypertension was not reported. probability of reporting hypertension increased with the number of compiled diagnosis fields (adjusted ors range: . - . ). there were no significant differences among italian regions, while private hospitals' reporting was less accurate. disorders of lipoid metabolism were more probably coded with hypertension (adjusted or: . ). conclusions: information from both ami and previous hospitali-sations would be needed to include hypertension in a comorbidity measure. abstract background: the angiotensin converting enzyme inhibitors (acei) should be considered the standard initial treatment of the systolic heart failure. this treatment is not recommended in patients with hypotension, although figures of systolic blood pressure around - mmhg during the treatment are allowed if the patient remains asymptomatic. objectives: to know the proportion of patients with systolic heart failure receiving treatment with acei, and the proportion of these patients with signs oh hypotension. design and methods: the electronic clinical records of all the patients diagnosed of systolic heart failure were reviewed. the electronic information system covers a % of the population of the basque country, approximately. diagnosis of heart failure was defined as the presence of any of the following cie- codes: or . or . . to evaluate the blood pressure, the last available determination was considered. results: out of patients with left heart failure, ( . %) have been prescribed acei. among the patients with blood pressure lower than mmhg (systolic) or than mmhg (diastolic), ( . %) were also receiving this treatment. conclusions: acei are clearly underprescribed in the basque country for the treatment of heart failure. attention should be given to the group at risk of hypotension. abstract background: epidemiologic studies have shown an association between c-reactive protein (crp) and cardiovascular endpoints in population samples. methods: in a longitudinal study of myocardial infarction (mi) survivors, crp was measured repeatedly (up to times) within a period of months. data on disease history and life style were collected at baseline. we examined the association between different variables and the level of crp using a random effects model. results: in total crp samples were collected in athens, augsburg, barcelona, helsinki, rome and stockholm. mean levels of crp were . , . , . , . , . , . [mg/l] respectively. body mass index (bmi) and chronic bronchitis (ever diagnosed) had the largest effect on crp ( % (for kg/m ) and % change from the mean level, respectively, p< . ). age classes showed a cubic function with a minimum at ages to . glycosylated hemoglobin (hba c) < . % as a measure of long-term blood glucose control and being male were found to be protective () % and ) % respectively, p< . ). conclusion: it was shown that bmi and history of bronchitis are important in predicting the level of crp. other variables, like alcohol intake, play a minor role in this large sample of mi patients. abstract background: during the last decades a remarkable increase in incidence rates of malignant lymphoma was seen. although some reasons are known or suspect underlying risk factors are not well understood. objectives: we studied the influence of medical radiation (x-ray, radiotherapy and szintigraphy) on the risk of malignant lymphoma. methods: we analysed data from a population-based case-control study with incident lymphoma cases in germany from - . after informed consent cases were pair-matched with controls recruited from registration office by age, gender and study region. data was collected in a personal interview. we analysed data using conditional logistic regression. results: the linear model shows an or = . /msv due to x-ray exposure and or = . ( %-ci = . - . ) comparing higher with lower exposure. radiotherapy shows an or = . (n = cases). there is no association between all lymphomas and szintigraphies but in the subgroup containing multiple myeloma, cll, malt-and marginalcell lymphoma we found an or = . ( %-ci = . - . ) in the multivariate model. discussion: no excess risk was observed for x-ray examinations. ionising radiation may increase risk for specific lymphoma subgroups. however, it should be noted that numbers in the subgroups are small and that radiation dose may be somehow inaccurate as no measures were available. abstract background: varus-alignment (bow-leggedness) is assumed to correlate with knee osteoarthritis (oa), but it is unknown whether varus-alignment precedes the oa or whether varus-alignment is a result of oa. objective: to assess the relationship between varusalignment and the development, as well as progression, of knee oa. methods: , participants in the rotterdam study were selected. knee oa at baseline and at follow-up (mean follow-up . years) was defined as kellgren & lawrence (k&l) grade , and progression of oa as an increase of k&l degree. alignment was measured by the femoro-tibial angle on baseline radiographs. multivariable logistic regression for repeated measurements was used. results: of , knees, . % showed normal alignment, . % varus-alignment, and . % valgus-alignment. comparison of high varus-alignment versus normal, low and mediate varus-alignment together, showed a two-fold increase in the development of knee oa. (or = . ; %ci = . - . ). the risk of progression was higher in the high varus group compared to the normal, low and mediate varus group (or = . ; %ci = . - . ). stratification for overweight gave similar odds ratio's in the overweight group, but weaker odds ratio's in the non-overweight group. conclusion: a higher value of varus-alignment is associated with the onset and progression of knee oa. abstract background: echocardiographic image quality in copd patients can be hampered by hyperinflated lungs. cardiovascular magnetic resonance imaging (cmr) may overcome this problem and provides accurate and reproducible information about the heart without geometric assumptions. objective: to determine the value of easily assessable cmr parameters compared to other diagnostic tests in identifying heart failure (hf) in copd patients. design and methods: participants were recruited from a cohort of copd patients = years. a panel established the diagnosis of hf during consensus meetings using all diagnostic information, including echocardiography. in a nested case-control study design, copd patients with hf (cases) and a random sample of copd patients without hf (controls) received cmr. the diagnostic value of cmr for diagnosing hf was quantified using univariate and multivariate logistic modelling and roc-area analyses. results: four easily assessable cmr measurements had significantly more added diagnostic value beyond clinical items (roc-area . ) than amino-terminal pro b-type natriuretic peptide (roc-area . ) or electrocardiography (roc-area . ). a 'cmr model' without clinical items had an roc-area of . . conclusion: cmr has excellent capacities to establish a diagnosis of heart failure in copd patients and could be an alternative for echocardiography in this group of patients. abstract background: the prevalence of overweight (i.e, body mass index [bmi] > = kg/m ) is increasing. new approaches to address this problem are needed. objectives: ) to assess the effectiveness of distance counseling (i.e., by phone and e-mail/internet) on body weight and bmi, in an overweight working population. ) to assess differences in effectiveness of the two communication methods. design and methods: overweight employees ( % male; mean age . ± . years; mean bmi . ± . kg/m ) were randomized to a control group receiving general information on overweight and lifestyle (n = ), a phone based intervention group (n = ) and an internet based intervention group (n = ). the intervention took months and used a cognitive behavioral approach, addressing physical activity and diet. the primary outcome measures, body weight and bmi, were measured at baseline and at six months. statistical analyses were performed with multiple linear regression. results: the intervention groups (i.e., phone and e-mail combined) lost . kg (bmi reduced by . kg/m ) over the control group (p = . ). the phone group lost . kg more than the internet group (p = . ). abstract objective: although an inverse gradient education-mortality has been shown in the general population, little is known about this trend in groups with higher risks of death.we examine differences in mortality by education and hiv-status among injecting drug users (idus) before and after introduction of highly active antiretroviral therapy (haart) in . methods: communitybased cohort study of idus recruited in aids prevention centres ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) abstract background: pancreatic cancer is an aggressive cancer with low survival time, with health-related quality of life (hrqol) being of major importance. objectives: the aim of our study was to assess both generic and disease-specific hrqol in patients with pancreatic cancer. methods: patients with suspected pancreatic cancer were consecutively included at admission to the hospital. hrqol was determined with the disease-specific european organization for research and treatment of cancer (eortc) health status instrument and generic euroqol (eq- d). results: a total of patients (mean age years ± , % men) were admitted with suspected pancreatic cancer. of these patients, ( %) had pancreatic cancer confirmed as final diagnosis. hrqol was significantly impaired in patients with pancreatic cancer for most eortc and eq- d scales in comparison to norm populations. the ed- d visual analogue scale (vas) and utility values were significantly correlated to the five functional scales, to the global health scale and to some but not all of the eortc symptom scales/items. conclusions: hrqol was severely impaired in patients with pancreatic cancer. there was a significant correlation between most eortc and eq- d scales. our results may facilitate further economic evaluations and aid health policy makers in resource allocation. abstract background: organised violence has health impact both on those who experience the violence directly and indirectly. the numbers of people affected by mass violence is alarming. substantial knowledge on the long-term health impact of organized violence is of importance for public health and for epidemiology. objectives: to investigate research results of long term mental health impact of organised violence. design and methods: a search of papers for the keywords genocide, organised violence, transgenerational effects, mental health was carried out in pubmed, science citation index and psychinfo. results: the systematic review on the long-term health impact of genocide showed that exposure to organised violence has an impact on mental health. methodological strenghts and weaknesses varied between studies. the found mental health consequences were associated with the country of research and the time of study. overall data showed organised violence has transgenerational impact on mental health of individuals and societies. conclusion: longitudinal studies have to be carried out to get further insight into the long-term health effects of organised violence. discussion: research results on mental health effects of organised violence have to be analysed in the context of changing concepts of illness. overweight is increasing and associated with various health problems. there are no well-structured primary care programs for overweight available in the netherlands. therefore, we developed a -month multidisciplinary treatment program in a primary care setting. the aim of the present study is to determine the feasibility and efficacy of a multidisciplinary treatment program on weight loss and risk profile in an adult overweight population. hundred participants of the utrecht health project are randomised to either a dietetic group or a dietetic plus physiotherapy group. the control group consist of another participants recruited from the utrecht health project and receives routine health care. body weight, waist circumference, blood pressure, serum levels, energy-intake and physical activity are measured at baseline, halfway and at the end of the treatment program. feasibility of the treatment program is assessed by response, compliance and program-associated costs and workload. efficacy is determined by analysing changes in outcome measures between groups over time using t-tests and anova repeated measurements. the treatment program is considered effective with at least a % difference in mean weight change over time between groups. positive evaluation of the multidisciplinary treatment program for overweight may lead to implementation in routine primary health care. abstract background: examining patient's quality of life (qol) before icu admission will permit to compare and analyze its relation with other variables. objectives: analyze qol of patients admitted to a surgical icu before admission and study its relation with baseline characteristics and outcome. design and methods: the study was observational and prospective in a surgical icu, enrolling all patients admitted between november and april . baseline characteristics of patients, history of co morbidities and quality of life survey score (qolss) were recorded. assessment of the relation between each variable or outcome and the total score of qolss was performed by multiple linear regression. results: total qolss demonstrated worse qol in patients with hypertension, cerebrovascular disease, renal insufficiency, severely ill (as measured by saps and asa physical status), and in older patients. there was no relation between qol and longer icu los. conclusions: preadmission qol correlates with age, severity of illness, comorbidities and mortality rates but is an able to predict longer icu stay. discussion: qolss appears to be a good indicator of outcome and severity of illness. abstract background: transient loss of consciousness (tloc) has a cumulative lifetime incidence of %, and can be caused by various disorders. objectives: to assess the yield and accuracy of initial evaluation (standardized history, physical examination and ecg), performed by attending physicians in patients with tloc, using follow-up as a gold standard. design and methods: adult patients presenting with tloc to the academic medical centre between february and may were included. after initial evaluation physicians made a certain, likely or no initial diagnosis. when no diagnosis was made additional cardiological testing, expert history taking and autonomic function testing were performed. the final diagnosis, after years follow-up, was determined by an expert committee. results: patients were included. after initial evaluation, % of the patients were diagnosed with a certain and % with a likely cause for their episodes. overall diagnostic accuracy was % ( %ci - %); % ( %ci - %) for the certain diagnoses and % ( %ci - %) for the likely diagnoses. conclusion and discussion: attending physicians make a diagnosis in % of patients with tloc after initial evaluation, with high accuracy. the use of abundant additional testing can be avoided in many patients. abstract background: the possibility of an influenza pandemic is one of the major public health challenges of today. risk perceptions among the general public may be important for successful public health measures to better control an outbreak situation. objectives: we investigated risk perception and efficacy beliefs related to an influenza pandemic in the general population in countries in europe and asia. design and methods: telephone interviews were conducted in . risk perception of an influenza pandemic was measured on a -point scale and outcome-and self-efficacy on a point scale (low-high). the differences in risk perception by country, sex and age were assessed with a general linear model including interaction effects. results: , persons were interviewed. the mean risk perception of flu was . and was significantly higher in europe ( . ) compared to asia ( . ) (p< . ) and higher in women ( . ) than men ( . ) (p< . ). outcome-and self-efficacy were lower in europe than asia. conclusion: in europe higher risk perceptions and lower efficacy beliefs were found as compared to asia. in developing preparedness plans for an influenza pandemic specific attention should therefore be paid to risk communication and how perceived self-efficacy can be increased. abstract background: increased survival of patients with cf has prompted interest towards their hrqol. objectives: .to measure hrqol and its predictors in cf patients cared for at the bambino gesuc hildren's hospital in rome; . to assess the psychometric properties of the italian version of the cf specific hrqol instrument (cystic fibrosis questionnaire, cfq). design and methods: crosssectional survey. all cf patients aged years or more were asked to complete the cfq (age-specific format). psychological distress was assessed through standardized questionnaires in patients (achenbach and general health questionnaire, ghq) and their parents (ghq and sf- ). results: one-hundred-eighteen patients ( males, females, age range to years) participated in the study (response rate %). internal consistency of cfq was satisfactory (cronbach alpha from . to . ); all item-test correlation were greater than . . average cfq standardized scores were very good in all domains (> on a - scale), except perceived burden of treatments ( ) and degree of socialization ( ). multiple regression analysis was performed to identify factors associated with different hrqol dimensions. conclusion: support interventions for these patients should concentrate on finding a balance between need to prevent infections and promotions of adequate, age-appropriate social interactions. abstract background: the metabolic syndrome (metsyn) -a clustering of metabolic risk factors with diabetes and cardiovascular diseases as the primary clinical outcomes -is thought to be highly prevalent with an enormous impact on public health. to date, consistent data in germany are missing. objective: the study was conducted to examine the prevalence of the metsyn (according to ncap atp iii-definition) among german patients in primary care. methods: the german-wide cross-sectional study run two weeks in october with randomly selected general practitioners included. blood glucose and serum lipids were analyzed, waist circumference and blood pressure assessed, data on smoking, dietary and exercise habits, regional and sociodemographic characteristics collected. abstract background: excessive infant crying is a common and often stress inducing problem than can ultimately result in child abuse. from previous research is known that maternal depression during pregnancy is related to excessive crying, but so far little attention is paid to paternal depression. objective: we studied whether paternal depression is independently associated to excessive infant crying. design and methods: in a prospective multiethnic population-based study we obtained depression scores of , mothers and , fathers at weeks pregnancy using the brief symptom inventory, and information on crying behaviour of , infants at months. we used logistic regression analyses in which we adjusted for depression of the mother, level of education, smoking and alcohol use. results: paternal depressive symptomatology was related to the widely used wessel's criteria for excessive crying (adusted odds ratio . , . - . ). conclusion: our findings indicate that paternal depressive symptomatology might be a risk factor for excessive infant crying. discussion genetic as well as other direct (e.g. interaction between father and child) or indirect (e.g. marital distress or poor circumstances) mechanisms could explain the found association. abstract background: in studying genetic background of congenital anomalies the comparison of affected cases to non-affected controls is popular method. investigation of case-parent triads uses observation of cases and their parents exclusively. methods: both casecontrol approach and log-linear case-parent triads model were implemented to spina bifida (sb) cases and their parents ( triads) and controls in analysis of impact of the c t and a c mthfr polymorphisms on occurrence of sb. results: observed frequencies for tt genotype were , % in sb children, , % in mothers, , % in fathers, , % in controls and for cc genotype were , % of sb children, , % of mothers, , % of fathers and , % of controls. both genotype frequencies in sb triads did not differ significantly from controls. case-control approach showed nonsignificant increase in risk of having sb for t allele carriers either in homozygous (or = , ) or heterozygous form (or = , ) and for c allele carriers in heterozygous form (or = , ). log-linear model revealed significant relative risk of sb in children with both tt and ct genotype (rr = , and rr = , respectively). child's genotype at a c and mother's genotypes did not contribute to the risk. conclusions: caseparent triads approach adds new information regarding impact of parental imprinting on congenital anomalies. abstract background: previous studies showed an association of autonomic dysfunction with coronary heart disease (chd) and with depression as well as an association of depression with chd. however, there is limited information on autonomic dysfunction as potential mediator of the adverse effect of depression on chd. objectives: to examine the role of autonomic dysfunction as a potential mediator of the association of depression with chd. design/ methods: we used data of participants aged - years of the ongoing population-based cross-sectional carla study ( % male). time-and frequency-domain parameters of heart rate variability (hrv) as a marker of autonomic dysfunction were calculated. prevalent myocardial infarction (mi) was defined as selfreported physician-diagnosed mi or diagnostic minnesota code in the electrocardiogram. depression was defined based on the cesd-depression scale. logistic regression was used to assess associations between depression, hrv and mi. results: in ageadjusted logistic regression models, there was no statistically significant association of hrv with depression, of depression with mi, or of hrv with mi in men and women. discussion/conclusion: the present analyses do not support the hypothesis of an intermediate role of autonomic dysfunction on the causal path from depression to chd. abstract background: hypertension is an established risk factor for cardiovascular disease. however, prevalence of untreated or uncontrolled hypertension is often high (even in populations at high risk). objectives: to assess the prevalence of untreated and of uncontrolled hypertension in an elderly east german population. design and methods preliminary data of a cross-sectional, populationbased examination of men and women aged - years were analysed. systolic (sbp) and diastolic blood pressure (dbp) were measured and physician-diagnosed hypertension and use of antihypertensive drugs were recorded. prevalence of hypertension was calculated according to age and sex. results: of all participants, . % were hypertensive ( . % of men, . % of women). of these, . % were untreated, . % treated but uncontrolled, and . % controlled. women were more often properly treated than men. the prevalence of untreated hypertension was highest in men aged - years ( . %) and lowest in men and women aged > = years ( . %). uncontrolled hypertension increases with age in both sexes. conclusion and discussion: in this elderly population, there is a high prevalence of untreated and uncontrolled hypertension. higher awareness in the population and among physicians is needed to prevent sequelae such as cardiovascular disease. abstract background: exposure to pesticides is a potential risk factor for subfertility, which can be measured by time-to-pregnancy (ttp). as female greenhouse workers constitute a major group of workers exposed to pesticides at childbearing age, a study was performed among these and a non-exposed group of female workers. objectives: to measure the effects of pesticide exposure on time-topregnancy. design and methods: data were collected through postal questionnaires with detailed questions on ttp, lifestyle factors, and work tasks (e.g. application of pesticides, re-entry activities, and work hours) during six months prior to conception of the most recent pregnancy. associations between ttp and exposure to pesticides were studied in cox's proportional hazards models among female greenhouse workers and referents. results: the initial fecundability ratio (fradjusted) for greenhouse workers versus referents was . ( %ci: . - . ). this fr proved to be biased by the reproductively unhealthy worker effect. restricting the analyses to fulltime workers only gave an fradjusted of . ( %ci: . - . ). among primigravidous greenhouse workers, an association was observed between prolonged ttp and gathering flowers (fr = . , %ci: . - . ). conclusion and discussion: this study adds some evidence to the hypothesis of adverse effects of pesticide exposure on time-topregnancy, but more research is needed. abstract background: hfe-related hereditary hemochromatosis (hh) is an iron overload disease for which screening is recommended to prevent morbidity and mortality. however, discussion has risen on the clinical penetrance of the hfe-gene mutations. objective: in the present study the morbidity and mortality of families with hferelated hh is compared to a normal population. methods: c yhomozygous probands with clinically overt hfe-related hh and their first-degree relatives filled in a questionnaire on health, diseases and mortality among relatives. laboratory results on serum iron parameters and hfe-genotype were collected. the self-reported morbidity, family mortality and laboratory results were compared with an age and gender matched subpopulation of the nijmegen biomedical study (nbs), a population-based survey conducted in the eastern part of the netherlands. results: twohundred-twenty-eight probands and first-degree relatives participated in the hefas. serum iron parameters were significantly elevated in the hefas population compared to the nbs controls. also, the morbidity within hefas families was significantly increased for fatigue, hypertension, liver disease, myocardial infarction, osteoporosis and rheumatism. mortality among siblings, children and parents of hefas probands and nbs participants was similar. discussion: the substantially elevated morbidity within hefas families justifies further exploration for a family cascade screening program for hh in the netherlands. abstract objectives: to evaluate awareness levels and effectiveness of warning labels in cigarette packs, among portuguese students enrolled in the th to the th grades. design and methods: a cross sectional-study was carried out in may ( ) in a high school population ( th- th grades) in the north of portugal (n = ). a confidential self-reported questionnaire was administered. warning labels effectiveness was evaluated by changes in smoking behaviour and cigarette consuption, during the period between june/ (before the implementation of the tobacco warnings labels in portugal) and may/ . continuous variables were compared by the t-test for paired samples and kruskal-wallis test. crude and adjusted odds ratios and confidential intervals were calculated by logistic regression analysis. results: the majority of students ( . %) have a high level of awareness about warning labels content. this knowledge was significantly associated with school grade and current smoking status. none of these variables was significantly associated with changes in smoking behaviour. although not reaching statistic significance, the majority of teenagers ( . %) increased or kept their smoking pattern. awareness level was not associated with smoking prevalence or consumption decreases. conclusions: current warning labels are ineffective in changing smoking behaviour among portuguese adolescents. abstract background: injuries are an important cause of morbidity. the presence of pre-existing chronic conditions (pecs) have been shown to be associated with higher mortality. objectives: aim of this study is to evaluate the association between pecs and risk of death in elder trauma patients. methods: an injury surveillance, based on the integration between emergency, hospital, and mortality databases of lazio region, year , was used. patients were the elder people visited at the emergency departments, and hospitalised. pecs were evaluated on the basis of the charlson comorbidity index (cci). to measure the effect of pecs on the probability of death, we used logistic regression. results: patients were admitted to the hospital. the . % of the injured subjects were affected by one or more chronic conditions. risk of death for non urgent and urgent patients increased at increasing cci score abstract background: c-reactive protein (crp) was shown to predict prognosis in heart failure (hf). objective: to assess variability of crp over time in patients with stable hf. methods: we measured high-sensitivity crp (hscrp) times ( -week intervals) in patients with stable hf. patients whose hscrp was > mg/dl or whose clinical status deteriorated were excluded. two consecutive hscrp measurements were available for patients: men, mean(sd) age . ( . ) years, % depressed left ventricular systolic function. forty-four patients had a third measurement. using the cutoff point of . mg/dl for prediction of adverse cardiac events we assessed the proportion of patients who changed risk category. results: median(p -p ) baseline hscrp was . mg/dl( . - . ). hscrp varied largely particularly for higher levels. the th and th percentiles of differences between first two measurements were ) . mg/dl and + . mg/dl. correlation coefficient between these measurements: . , p< . . eleven ( %) patients changed risk category, kappa = . , p< . . among patients whose first two measurements were concordant, . % changed category in third measurement, kappa = . , p< . . conclusion: large variability in hscrp in stable hf may decrease the validity of risk stratification based on single measurements. it remains to be demonstrated whether the pattern of change over time adds predictive value in hf patients. abstract background: instrumental variables can be used to adjust for confounding in observational studies. this method has not yet been applied with censored survival outcomes. objectives: to show how instrumental variables can be combined with survival analysis. design and methods: in a sample of patients with type- diabetes who started renal-replacement therapy in the netherlands between and , the effect of pancreas-kidney transplantation versus kidney transplantation on mortality was analyzed using region as the instrumental variable. because the hospital could not be chosen with this type of transplantation, patients can be assumed to be naturally randomized across hospitals. we calculated an adjusted difference in survival probabilities for every time point including the appropriate confidence interval (ci %). results: the -year difference in survival probabilities between the two transplantation methods, adjusted for measured and unmeasured confounders, was . (ci %: . - . ) favoring the pancreas-kidney transplantation. this is substantially larger than the intention-to-treat estimate of . (ci %: . - . ) where policies are compared. conclusion and discussion: instrumental variables are not restricted to uncensored data, but can also be used with a censored survival outcome. hazard ratios with this method have not yet been developed. the strong assumptions of this technique apply similarly with survival outcomes. . ] . sir of coronary heart disease was . [ %ci: . - . ] and remained significantly increased up to years of follow-up. cox regression analysis showed a . -fold ( % ci, . - . ) increased risk of congestive heart failure after anthracyclines and a . -fold ( % ci, . - . ) increased risk of coronary heart disease after radiotherapy to the mediastinum. conclusion: the incidence of several cardiac diseases was strongly increased after treatment for hl, even after prolonged follow-up. anthracyclines increased the risk of congestive heart failure and radiotherapy to the mediastinum increased the risk of coronary heart disease. abstract background: the concept of reproductive health is emerging as an essential need for health development. objectives: to know the opinions of parents, teachers and students about education of reproductive health issues to students of mid and high schools. design and methods: focus group discussions (fgd) as a qualitative research was chosen. a series of group discussions with participation of persons ( students, teachers, and parents) was held. each group had included to persons. results: all the participants noted to a true need in education of puberty health in order to provide essentials for pre-adolescent students to adopt the psycho-and somatic changes of puberty. however, a few fathers and a group of mothers believed that education of family planning is not suitable for students. a need for education of aids and marital problems for students was the major concern in all groups. the female students emphasized a need for programming counseling in pre-marital period. conclusion: essentials in puberty health, family planning, aids and marital problems should be provided in mid-and high schools in order to narrow the knowledge gap of the students. abstract background: the association between social support and hypertension in pregnancy remains controversial. objective: the objective of this study was to investigate whether level of social support is a protective factor against preeclampsia and eclampsia. design and methods: a case-control study was carried out in a public high-risk maternity hospital in rio de janeiro, brazil. between july -may , all cases, identified at diagnosis, and controls, matched on gestational age, were included in the study. participants were interviewed about clinical history, socio-demographic and psychosocial characteristics. the principal exposure was the level of social support available during the pregnancy, using the medical outcomes study scale. adjusted odds ratios were estimated using multivariate conditional logistic regression. results: multiparous women with a higher level of social support had a lower risk of presenting with preeclampsia and eclampsia (or = . ), although this association was not statistically significant ( % ci . - . ). in primiparous women, a higher level of social support was seen amongst cases (or = . ; % ci . - . ). an interaction between level of social support and stressful life events was not identified. these results contribute to increased knowledge of the relationship between preeclampsia and psychosocial factors in low-income pregnant and puerperal women. abstract background: current case-definitions for cfs/me are designed for clinical-use and not appropriate for health needs assessment. a robust epidemiological case-definition is crucial in order to achieve rational allocation of resources to improve service provision for people with cfs/me. objectives: to identify the clinical features that distinguish people with cfs/me from those with other forms of chronic fatigue and to develop a reliable epidemiological case-definition. methods-primary care patient data for unexplained chronic fatigue was assessed for symptoms, exclusionary and comorbid conditions and demographic characteristics. cases were assigned to disease and non-disease groups by three members of the chief medical officer's working group on cfs/me (reliability-cronbach's alpha . ). results: preliminary multivariate analyses were conducted and classification and regression tree analysis included a -fold cross-validation approach to prevent over fitting. the results suggested that there were at least four strong discriminating variables for cfs/ me with 'post-exertional malaise' being the strongest predictor. risk and classification tables showed an overall correct classification rate of . %. conclusion: the analyses demonstrated that the application of the combination of the four discriminating variables (the defacto epidemiological case-definition) and predefined comorbid conditions had the ability to differentiate between cfs/me and non-cfs/me cases. abstract background: infection with high-risk human papillomavirus (hpv) is a necessary cause for cervical cancer. vaccines against the most common types (hpv , hpv ) are being developed. relatively little is known about factors associated with hpv or hpv infection. we investigated associations between lifestyle factors and hpv and hpv infection. methods: uk women aged - years with a recent abnormal cervical smear underwent hpv testing and completed a lifestyle questionnaire. hpv and hpv status was determined using type-specific pcrs. associations between lifestyle factors and hpv status were assessed by multivariate logistic regression models. results: . % ( %ci . %- . %) of women were hpv -positive. . % ( % ci . %- . %) were hpv -positive. for both types, the proportion testing positive decreased with increasing age, and increased with increasing grade of cytological abnormality. after adjusting for these factors, significant associations remained between (i) hpv and marital, employment, and smoking status and (ii) hpv and marital status and contraceptive pill use. gravidity, ethnicity, barrier contraceptive use and socio-economic status were not related to either type. conclusions we identified modest associations between several lifestyle factors and hpv and hpv . studies of this type help elucidate hpv natural history in different populations and will inform development of future vaccine delivery programmes. in ageing men testosterone levels decline, while cognitive function, muscle and bone mass, sexual hair growth, libido and sexual activity decline and the risk of cardiovascular diseases increase. we set up a double-blind, randomized placebo-controlled trial to investigate the effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, vascular function and risk factors, and bone mineral density in older hypogonadal men. we recruited men with serum testosterone levels below nmol/l and ages - years. they were randomized to either four capsules of mg testosterone undecanoate (tu) or placebo daily for weeks. primary endpoints are functional mobility and quality of life. secondary endpoints are body composition, cognitive function, aortic stiffness and cardiovascular risk factors and bone mineral density. effects on prostate, liver and hematological parameters will be studied with respect to safety. measure of effect will be the difference in change from baseline visit to final visit between tu and placebo. we will study whether the effect of tu differs across subgroups of baseline waist girth, testosterone level, age, and level of outcome under study. at baseline, mean age, bmi and testosterone levels were (yrs), (kg/m ) and .x (nmol/l), respectively. abstract at a student population, the carie's prevalence was , %. objectives: to evaluate the efficiency between two types of oral health education programmes and the adherence towards tooth brushing. study design: case control study: youngsters took part, in the case group. an health education programme was carried out in schools and included two types of strategies: a participative strategy (learning based on the colouring of the dental plaque) towards a case group; and a traditional strategy (oral expository method) towards a control group. during the outcome of the programmes, the oral health condition evaluation was done through cpo index, the adherence towards tooth brushing and the (iho's) oral hygiene index. results: in the initial dental exam the (iho) average was of , . three months after the application of the oral health programme, there was a general decrease in the average of iho's to , . discussion and conclusion: in the case group the decrease was higher: , to , . the students submitted to a session of oral health education based on the colouring of the dental plaque showed an lower iho's average and higher knowledge. this can be due to the teaching session being more active, participative and demonstrative. abstract background: violence perpetuated by adolescents is a major problem in many societies. objectives: the aim of this study is to examine high school students' violent behaviour and to identify predictors. design and methods: a cross-sectional study was conducted in timis county, romania between may-june . the sample consisted of randomly selected classes, stratified proportionally according to grades - , high school profile, urban and rural environment. the students completed a self administered questionnaire in their classroom. a weighting factor was applied to each student record to adjust for non-response and for the varying probabilities of selection. results: a total of students were included in the survey. during the last months, . % of adolescents got mixed into a physical fight outside school and . % on school property. abstract background: drug use by adolescents has become an increasing public health problem in many countries. objectives: the aim of this study is to identify prevalence of drug use and to examine high school students' perceived risks of substance use. design and methods: a cross-sectional study was conducted in timis county, romania between may-june . the sample consisted of randomly selected classes, stratified proportionally according to grades - , high school profile, urban and rural environment. the students completed a self administered questionnaire in their classroom. eighteen items regarding illicit drug use suggesting different intensity of use were listed. the response categories were 'no risk', 'slight risk', 'moderate risk', 'great risk' and 'don't know'. results: a total of students were included in the survey. the lifetime prevalence of any illicit drug was . %. significant beliefs associated with drug use are: trying marijuana once or twice (p< . ), smoking marijuana occasionally (p = . ), trying lsd once or twice (p = . ), trying cocaine once or twice (p = . ), trying heroine once or twice (p = . ). conclusion: the overall drug use prevalence is small. however, use of some drugs once or twice is not seen as a very risky behaviour. abstract background: the health ombudsman service was created in ceara´, brazil, in , with the objective of receiving user opinions about public services. objectives: to describe user profiles, evaluating their satisfaction with health services and the ombudsman service itself. design and methods: a transversal and exploratory study with a random sample of users who had used the service in the last three months. the data were analyzed with the epi info program. results: women were those who used the service most ( . %). the users sought the service for complaints ( . %), guidance ( . %) and commendation ( . %). users made the following complaints about health services: lack of care ( . %), poor assistance ( . %) lack of medication ( . %). in relation to the ombudsman service, the following failures were mentioned: lack of autonomy ( . %), delay in solving problems ( . %) and few ombudsmen ( . %). conclusion: participation of the population in use of the serviced is small. the service does not satisfy the expectations of users, it is necessary to publicize the service and try to establish an effective partnership between users and ombudsmen so that the population finds in the ombudsman service an instrument to put into effect social control and improve the quality of health services. in chile, the rates of breast cancer and diabetes have dramatically increased in the last decade. the role of insulin resistance in the development of breast cancer, however, remains unexplored. we conducted a hospital-based case-control to assess the relationship of insulin resistance (ir) and breast cancer in chilean pre and postmenopausal women. we compared women, - y, with incident breast cancer diagnosed by biopsy and controls with normal mammography. insulin and glucose were measured in blood and ir was calculated by homeostasis model assessment method. anthropometric measurements and socio-demographic and behavioural data were also collected. odds ratios (ors) and % confidence intervals (cis) were estimated by multivariate logistic regression. the risk of breast cancer increased with age. ir was significantly associated to breast cancer in postmenopausal women (or = . , %ci = . - . ), but not in premenopausal (p> . ). socioeconomic status and smoking appeared as important risk factors for breast cancer. obesity was not associated with breast cancer at any age (p> . ). in these women, ir increased the risk of breast cancer only after menopause. overall, these results suggest a different risk pattern for breast cancer before and after menopause. keywords: insulin resistance; breast cancer; chile. abstract background: previous european community health indicators (echi) projects have proposed a shortlist of indicators as a common conceptual structure for health information. the european community health indicators and monitoring (echim) is a -year project to develop and implement health indicators and to develop health monitoring. objectives: our aim is to assess the availability and comparability of the echi-shortlist indicators in european countries. methods: four widely used health indicators i) perceived general health ii-iii) prevalence of any and certain chronic diseases or conditions iv) limitations in activities of daily living (adl) were evaluated. our evaluation of available sources for these indicators is based on the european health interview & health examination surveys database ( surveys in chile, breast cancer, obesity and sedentary behaviour rates are increasing. the role of specific nutrients and exercise in the risk of breast cancer remains unclear. the aim of the present study was to evaluate the role of fruits and vegetables intake and physical activity in the prevention of breast cancer. we undertook an age matched case-control study. cases were women with breast cancer histologically confirmed and controls were women with normal mammography, admitted to the same hospital. a structured questionnaire was used to obtain dietary information and measurement of physical activity was obtained from the international physical activity questionnaire. odds ratios (ors) and % confidence intervals (cis) were estimated by conditional logistic regression adjusted by obesity, socioeconomic status and smoking habit. a significant association was found with fruit intake (or = . , %ci = . - . ). the consumption of vegetables (or = . , %ci = . - . ), moderate (or = . , %ci = . - . ) and high physical activity (or = . , %ci = . - . ) were not observed as protective factors. in conclusion, the consumption of fruit is protective in breast cancer. these findings need to be replicated at chile to support the role of diet and physical activity in breast cancer and subsequence contribution in public health policy. keywords: diet; physical activity; breast cancer; chile. the role of trace elements in pathogenesis of liver cirrhosis and its complications is still not clearly understood. serum concentrations of zinc, copper, manganese and magnesium were determinated in patients with alcoholic liver cirrhosis and healthy subjects by means of plasma sequential spectrophotometer. serum levels of zinc were significantly lower (median . vs . lmol/l, p = . ) in patients with liver cirrhosis in comparison to controls. serum levels of copper were significantly higher in patients with liver cirrhosis ( . vs . lmol/l, p< . ) as well as manganese ( . vs . lmol/l, p = . ). concentration of magnesium was not significantly different between patients with liver cirrhosis and controls ( . vs . mmol/l, p = . ). there was no difference in trace elements concentrations between child-pugh groups. zinc level was significantly lower in patients with hepatic encephalopathy in comparison to cirrhotic patients without encephalopathy ( . vs . lmol/l, p = . ). manganese was significantly higher in cirrhotic patients with ascites in comparison to those without ascites ( . vs . lmol/l, p = . ). correction of trace elements concentrations might have beneficial effect on complications and maybe progression of liver cirrhosis. it would be recommendable to provide analyzis of trace elements as a routine. abstract background: respiratory tract infections (rti) are very common in childhood and knowledge of pathogenesis and risk factors is required for effective prevention. objective: to investigate the association between early atopic symptoms and occurrence of recurrent rti during first years of life. design and methods: in the prospective prevention and incidence of asthma and mite allergy birth cohort study, children were followed from birth to the age of years. information on atopic symptoms, potential confounders, and effect modifiers like passive smoking, daycare attendance and presence of siblings was collected at ages months and year by parental questionnaires. information on rti was collected at ages , , , and years. results: children with early atopic symptoms, i.e. itchy skin rash and/or eczema or doctordiagnosed cow's milk allergy at year of age had a slightly higher risk to develop recurrent rti (aor . ( . - . ); and . ( . - . ), respectively). the association between atopic symptoms and recurrent rti was stronger in children whose mother smoked during pregnancy and who had siblings (aor . ( . - . ) the aim : the aim of the study was to assess the relative risk (rr) of obesity and abdominal fat distribution on the insulin resistance (ir), diabetes, hyperlipidemia and hypertension in polish population. materials and methods: subjects at age - , were randomized and invited to the study. in participants anthropometric and blood pressure examination was performed. fasting lipids, fasting and after glucose load glucose and insulin were determined. ir was defined as the upper quartile of the homa-ir distribution for the normal glucose tolerant population. results: overweight and obesity was observed in , % and , % of subjects. visceral obesity was found in subjects ( , %-men and , %-women). rr of ir in obesity was , ( % ci: , - , ), for obese subjects at age below was , ( % ci: , - , ). in men with visceral obesity rr of ir was the highest for men aged below . rr of diabetes was increasing with the increase of body weight, in obese subjects with abdominal fat distribution was , ( %ci: , - , ). the same was observed for the hypertension and hyperlipidemia. conclusions: obesity and the abdominal fat distribution seems to be an important risk factor of ir, diabetes, hypertension, hiperlipidemia, especially in the younger age groups. abstract background: age as an effect modifier in cardiovascular risk remains unclear. objective: to evaluate age-related differences in the effect of risk factors for acute myocardial infarction (ami). methods: in a population-based case-control study, with data collected by trained interviewers, consecutive male cases of first myocardial infarction (participation rate %) and randomly selected male control dwellers (participation rate %) were compared. effect-measure modification was evaluated by the statistical significance of a product term of each independent variable with age. unconditional logistic regression was used to estimate ors in each age stratum (< years/> years). results: there was a statistically significant interaction between education (> vs. < years), sports practice, diabetes and age: the adjusted (education, ami family history, dyslipidemia, hypertension, diabetes, angina, waist circumference, sports practice, alcohol and caffeine consumption, and energy intake) ors ( %ci) were respectively . ( . - . ), . ( . - . ) and . ( . - . ) in younger, and . ( . - . ), . ( . - . ) and . ( . - . ) in older participants. conclusions: in males, age has a significant interaction with education, sports practice and diabetes in the occurrence of ami. the effect is evident in the magnitude but not in the direction of the association. abstract there are few studies on the role of diet in lung cancer etiology. thus, we calculated both, squamous cell and small cell carcinoma risks in relation to the frequency of consumption of vegetables, cooked meat, fish and butter in silesian male in industrial area of poland. in the case-control study, the studied population comprised men with squamous cell carcinoma and men with small cell carcinoma, and healthy controls. multivariate logistic regression was employed to calculate lung cancer risk in the relation to simultaneous influence of dietary factors. the relative risk was adjusted for age and smoking. we observed a significant decrease in lung cancer risk related to more frequent consumption of raw vegetables, cooked meat and fish. however, stronger protective effect was reported for squamous cell carcinoma. frequent fish consumption significantly decreases the risk especially in cigarette smokers. the frequent consumption of pickles lowers squamous cell carcinoma risk in all cases but small cell carcinoma risk only in smokers. the presence of butter, cooked meat, fish and vegetables in diet significantly decreases the lung cancer risk especially in smokers. the association between diet and lung cancer risk is more pronounced for squamous cell carcinoma. abstract background: in functional disease research selection mechanisms need to be studied to assure external validity of trial results. objective: we compared demographic and disease-specific characteristics, history, co-morbidity and psychosocial factors of patients diagnosed, approached and randomised for a clinical trial analysing the efficacy of fibre therapy in irritable bowel syndrome (ibs). design and methods: in primary care patients were diagnosed with ibs by their gp in the past two years. characteristics were compared between ( ) randomised patients (n = ); ( ) patients who did not give their informed consent (n = ); ( ) patients who decided not to participate (n = ); and ( ) those not responding to the mailing (n = ). results: the groups showed no significance differences in age and gender ( % females, mean age years, s.d. ). patients consulting their gp for the trial compared to patients not attending their gp showed significant more severe ibs symptoms, more abdominal pain during the previous three months, and a longer history of ibs (p< , ). patients randomised have more comorbidity (p = , ). conclusion and discussion: patients included in this ibs trial differ from no participating and excluded patients mainly in ibs symptomatology, history and comorbidity. this may affect the external validity of the trial results. abstract objectives: to evaluate smoking prevalence among teenagers and identify associated social-behavioral factors. study design and methods: a cross sectional-study was carried out in may ( ) in high school population ( th- th grades) in the north of portugal (n = ). a confidential self-reported questionnaire was administered. crude and adjusted odds ratios and confidence intervals were calculated by logistic regression analysis. results: overall smoking prevalence was . % (boys = . %; girls = . %) (or = . ; ci % = . - . ; p< . ). smoking prevalence was significantly and positively associated with gender, smoking parents, school failure and school grade; in the group of students with smoking relatives, smoking was significantly associated with parents who smoke near the student (or = . ; ci % = . - . ; p< . ); in the group of the secondary grade ( th- th grades) smoking was significantly associated with belonging to 'non science-courses' (or = . ; ci % = . - . ; p = . ). conclusions: smoking is a growing problem among portuguese adolescents, increasing with age, prevailing among males, although major increases have been documented in the female population. parents' behaviours and habits have an important impact in their children's smoking behaviour. school failure is also an important factor associated with smoking. there is a need for further prevention programmes that should include families and consider students' social environment. abstract background: social environment of school can contribute to etiology of health behaviors. objective: to evaluate the role of school context for substance abuse in youth. design: a cross-sectional study was carried out in , using self-completed classroomadministered questionnaire. subjects: from a representative sample of students, a sub-sample of students was selected (including / classes with at least persons without missing data)*. methods: substance abuse was measured by: tobacco smoking at present, episodes of drunkenness and marijuana use in the lifetime. overall index was created as main independent variable, ranging - (cronbach's alpha = . ). class membership, type of school, gender, place of domicile, and school climate were included as contextual variables, measured on individual or group level. results: on individual level, the mean index was equal to . (sd = . ), and ranged from . in general comprehensive schools to . in basic vocational schools and from . to . for separated classes. about . % of total variance in this index may be attributed to differences between classes. conclusion: individual differences in substance abuse in youth could be partly explained by factors at school level. * project no po d . abstract background: rates of c-section in brazil are very high, . % in . brazil illustrates an extreme example of medicalization of birth. c-section, as any major surgery, increases the risk of morbidity, which can persist long after discharge from hospital. objectives: to investigate how social, reproductive, prenatal care and delivery factors interact after hospital discharge, influencing post partum complications. design and methods: a cross-sectional study of women gathered information through home interviews and clinical examination during post-partum. a hierarchical logistic regression model of factors associated with post-partum complications was applied. results: physical and emotional post partum complications were almost twice as high among women having c-section. most of this effect were associated with lower socioeconomic conditions which influences, were mainly explained by longer duration of delivery (even in the presence of medical indications), and less social support when returning home. conclusion: risk of c-section complications is higher among women from the lower socioeconomic strata. social inequalities mediate the association between type of delivery and postpartum complications. discussion: c-section complications should be taken into account when decisions concerning type of delivery are made. social support after birth, from the public health sector, has to be provided for women in socioeconomic deprivation. the relationship between unemployment and increased mortality was previously reported in western countries. the aim of this study was to assess the influence of the changes in unemployment rate on survival in general population in northern poland at the time of economic transition. to analyze the association between the unemployment and risk of death we collected survival data from death certificates and data on rates of unemployment from regions of gdansk county from period - . kaplan-meier method and cox proportional hazard model were used in univariate and multivariate analysis. a change of unemployment (percentage) in the year of death in the area of residence, sex and educational level ( categories) were included into multivariate analysis. the change of unemployment rate was associated with significantly worse overall survival: hazard ratio . % confidence interval . to . . the highest risk associated with the change of unemployment in the area of residence was for death from congenital defects (hazard ratio . % confidence interval . to . ) and for death from cardiovascular diseases (hazard ratio . % confidence interval . to . abstract background: there is no evidence from randomized trials as to whether or not educational interventions improve voluntary reporting systems in terms of quantity or quality. objectives: evaluation of the effectiveness of educational outreach visits aimed at improving adverse drug reaction (adr) reporting by physicians design and methods: cluster-randomized controlled trial covering all health system physicians in northern portugal. four spatialclusters assigned to intervention group (n = ) received outreach visits tailored to training needs detected in previous study and clusters were assigned to the control (n = ). the main was the total number of reported adr; the second was the number of serious, unexpected, high-causality and new-drug-related adr. a follow-up was conducted for a period of months. results: the intervention increased reports as follows: total adr, . -fold (p< . ); serious adr, . -fold (p = . ); high-causality adr, . -fold (p< . ); unexpected adr, . -fold (p< . ); and newdrug-related adr, . -fold (p = . ). the intervention had its maximum effect during the first four months ( . -fold increase, p< . ), yet the effect was nonetheless maintained over the four month periods post-intervention (p = . ). discussion and conclusion: physician training based on academic detailing visits improves reporting quality and quantity. this type of intervention could result in sizeable improvements in voluntary reporting in many countries. there were no evidence of differences in absolute indications between the years. conclusion: most of the increase in rates in the period may be attributable to relative and non-medical indications. discussion policies to promote rational use of c-sections should take into account the role played by obstetrician's convenience and the increased medicalization of birth on cesarean rates. abstract background: the changing environment has led to unhealthy dietary habits and low physical activity of children resulting in overweight/obesity and related comorbid conditions. objective: idefics is a five-year multilevel epidemiological approach proposed under the sixth eu framework to counteract the threatening epidemic of diet-and lifestyle-induced morbidity by evidence-based interventions. design and methods: a population-based cohort of . children to years old will be established in nine european countries to investigate the aetiology of these diseases. culturally adapted multi-component intervention strategies will be developed, implemented and evaluated prospectively. results: idefics compares regional, ethnic and sex-specific distributions of the above disorders and their key risk factors in children within europe. the impact of sensory perception, genetic polymorphisms and the role of internal/external triggers of food choice and children's consumer behaviour are elucidated. risk profile inventories for children susceptible to obesity and its co-morbid conditions are identified. based on controlled intervention studies an evidencebased set of guidelines for health promotion and disease prevention is developed. conclusions: provision of effective intervention modules, easy to implement in larger populations, may reduce future obesity related disease incidence. discussion: transfer of feasible guidelines into practice requires involvement of health professionals, stakeholders and consumers. abstract background: non-medically indicated cesarean deliveries increase morbidity and health care costs. brazil has one of the highest rates of caesarean sections in the world. variations in rates are positively associated with socioeconomic status. objectives: to investigate factors associated with cesarean sections in public and private sector wards in south brazil. design and methods: cross sectional data from post partum interviews and clinical records of consecutive deliveries ( in the main public and in a private maternity) was analyzed using logistic regression. results: multiple regression showed privately insured women having much higher cesarean rates than those delivering in public sector wards (or = . ; ci %: . - . ). obstetricians individual rates varied from %- %. doctors working in both, public and private sectors had a higher rates of cesarean in private wards (p< . ). wanting and having a cesarean was significantly more common among privately insured women. conclusion: women from wealthier families are at higher risk of cesarean, particularly those willing this type of delivery and whose obstetrician works in the private sector. discussion: women potentially at lower clinical risk are more like to have a caesarean. the obstetricians' role and women's preferences must be further investigated to tackle this problem. abstract background: in the netherlands, bcg-vaccination is offered to immigrant children and children of immigrant parents in order to prevent severe tuberculosis. the effectiveness of this policy has never been studied. objectives: assessing the effectiveness of the bcg-vaccination policy in the netherlands. design and methods: we used data on the size of the risk population per year (from statistics netherlands), number of children with meningitis or miliary tuberculosis in the risk population per year, and vaccination status of those cases (from the netherlands tuberculosis register) over the period - . we estimated the vaccine efficacy and annual risk of acquiring meningitis or miliary tuberculosis by log-linear modelling and treating the vaccination coverage as missing data. results: in the period - cases of meningitis or miliary tuberculosis were registered. the risk for unvaccinated to children to acquire such a serious tuberculosis infection was . ( %ci . - . ) per per year; the reduction in risk for vaccinated children was % ( %ci - %). conclusion and discussion: this means that, discounting future effects with %, a ( %ci: - ) extra children should be vaccinated to prevent one extra case of meningitis or miliary tuberculosis. given that bcg-vaccination is relatively inexpensive, the current policy could even be cost-saving. abstract background: psychotic symptom experiences in the general population are frequent and often longlasting. objectives: the zurich cohort study offered the opportunity of differentiating the patterns of psychotic experiences over a span of years. design and methods: the zurich study is based on a stratified community sample of persons born in (women) and (men). the data were collected at six time points since . we examined variables from two subscales of the scl- -r -'paranoid ideation' and 'psychoticism' -using factor analysis, cluster analysis and polytomous logistic regression. results: two new subscales were derived representing 'thought disorders' and 'schizotypal signs'. continously high symptom load on one of these subscales (both subscales) was found in % ( . %) of the population. cannabis use was the best predictor of continuously high symptom load in the 'thought disorders' subscale, whereas several variables representing adversity in childhood / youth were associated with continuously high symptom load in the 'schizotypal signs' subscale. conclusion and discussion: psychotic experiences can be divided at least in two different syndromes -thought disorders and schizotypal signs. despite similar longitudinal course patterns and also similar outcomes these syndromes rely on different risk factors, thus possibly defining separate pathways to psychosis. abstract background: the reasons for the rise in asthma and allergies remain unclear. to identify influential factors several european birth cohort studies on asthma and allergic diseases have been initiated since . objective: the aim of one work package within the global allergy and asthma european network (ga len), sponsored by the european commission, was to identify and compare european birth cohorts specifically designed to examine asthma and allergic diseases. methods: for each study, we collected detailed information (mostly by personal visits) regarding recruitment process, study setting, follow-up rates, subjective/objective outcomes and exposure parameters. results: by june , we assessed european birth cohort studies on asthma and allergic diseases. the largest recruited over children each. most studies determined specific immunoglobulin e levels to various allergens or used the isaac questionnaire for evaluation of asthma or allergic rhinitis symptoms. however, the assessment of other objective and subjective outcomes (e.g. lung function or definitions of eczema) were rather heterogeneous across the studies. conclusions due to the unique cooperation within the ga len project a common database was established containing study characteristics of european birth cohorts on asthma and allergic diseases. the possibility to pool data and perform meta-analyses is currently being evaluated. abstract background: birth weight is an important marker of health in infancy and health trajectories later in life. social inequality in birth weight is a key component in population health inequalities. objective: to comparatively study social inequality in birth weight in denmark, finland, norway, and sweden from to . design and methods as part of the nordic collaborative project on health and social inequality in early life (norchase), register-based data covering all births in all involved countries - was linked with national registries on parental socioeconomic position, covering a host of different markers including income, education and occupation. also, nested cohort studies provide opportunity to test hypotheses of mediation. results: preliminary results show that the social inequality in birth weight, small for gestational age, and low birth weight has increased in denmark through out the period. also, preliminary results from finland, norway and sweden will be presented. discussion: crosscountry comparisons pose several methodological challenges. these challenges include characterizing the societal context of each country so as to correctly interpret inter-country differences in social gradients, along with dealing with differences in the data collection methods and classification schemes used by different national registries. also, strategies for influencing policy will be discussed. abstract background: modifying the availability of suicide methods is a major issue in suicide prevention. objectives: we investigated changes in the proportion of firearm suicides in western countries since the 's, and their relation to the change of legislation and regulatory measures. design and methods: data from previous publications, from the who mortality database, and from the international crime victims survey (icvs) were used in a multilevel analysis. results: multilevel modeling of longitudinal data confirmed the effect of the proportion of households owning firearms on firearm suicide rates. several countries stand out with an obvious decline in firearm suicides since the s: norway, united kingdom, canada, australia, and new zealand. in all of these countries legislative measures have been introduced which led to a decrease in the proportion of households owning firearms. conclusion and discussion: the spread of firearms is a main determinant of the proportion of firearm suicides. legislative measures restricting the availability of firearms are a promising option in suicide prevention. abstract background: fatigue is a non-specific but frequent symptom in a number of conditions, for which correlates are unclear. objectives: to estimate socio-demographic and clinical factors determining the magnitude of fatigue. methods: as part of a follow-up evaluation of a cohort of urban portuguese adults, socio-demographic and clinical variables for consecutive participants were collected through personal interview. lifetime history of chronic disease diagnosis was inquired (depression, cancer, cardiovascular, rheumatic, and respiratory conditions), anthropometry was measured, and haemoglobin determined. krupp's -item fatigue severity scale was applied and severe fatigue defined as mean score over . mean age (sd) was . ( . ) and . % of participants were females. logistic regression was used to compute adjusted odds ratios, and attributable fractions were estimated using the formula ar = -s(?j/orj). results: adjusted for age and clinical conditions, female gender (or = . , %ci: . - . ) and education (under -years schooling: or = . , %ci: . - . ) were associated with severe fatigue. obesity (or = . , %ci: . - . ) and diagnosed cardiovascular disease (or = . , %ci: . - . ) also increased fatigue. attributable fractions were . % for gender, . % for education, . % for obesity, and . % for cardiovascular disease. conclusion: gender and education have large impact on severe fatigue, and, to a lesser extent, obesity and cardiovascular disease. abstract introduction: analysis of infant mortality allows identification of death contributing factors and assessment of child health care quality. objective: to study characteristics of infant and fetal mortality using data from a committee for prevention of maternal and infant mortality, in sobral, brazil. methods: all cases of infant deaths between and were analyzed. medical records were reviewed and mothers, interviewed. using a tool to identify preventable deaths (seade classification -brazil) the committee characterized causes of death. meetings with governmental groups involved in family health care took place to identify death contributing factors. results: in , infant mortality decreased from . to . . in the next years there was an increase from . to . . the increase in was due to respiratory illnesses. in , was due to diarrhea. analysis of preventable deaths indicated a reduction from to deaths that could have been prevented by adequate gestational care, and an increase in preventable deaths by early diagnosis and treatment. conclusion: pre-natal and delivery care improved whereas care for children less than yr old worsened. analysis of death causes allowed a reduction of infant mortality rate to . abstract objective: to identify dietary patterns and its association with metabolic syndrome. design and methods: we evaluated noninstitutionalised adults. diet was assessed using a semi-quantitative dietary frequency questionnaire, and dietary patterns were identified using principal components analysis followed by cluster analysis (k-means method) with bootstrapping (choosing the clusters presenting the lowest intra-cluster variance). metabolic syndrome (mets) was defined according to the ncep-atp-iii. results: the overall prevalence of metabolic syndrome was . %. in the population sample clusters were identified in females - .healthy, .milk/soup; .fast food; .wine/low calories; and in males - .milk/carbohydrates; . codfish/soup; .fast food; .low calories. in males, using milk/carbohydrates as the reference and adjusting for age and education, high blood pressure (or = . ; %ci: . - . ) and high triglycerides (or = . ; %ci: . - . ) were associated with the fast food pattern, and low calories pattern presented higher frequency of high blood pressure (or = . ; %ci: . - . ). in females, after age and education adjustment, no significant association was found either with metabolic syndrome or its individual features and the dietary patterns identified. conclusion: we found no specific dietary pattern associated with an increased prevalence of metabolic syndrome. however, a fast food diet was significantly more frequent in males with dyslipidemia and high blood pressure. abstract aim: to determine the prevalence of stress urinary incontinence (sui) before, during pregnancy and following childbirth, and also to analyse the impact of a health education campaign about sui prevention, following childbirth in viana district, portugal. methods: participants (n = ), interviewed during hospitalization, after birth and two months later at health centres, were divided into two groups: a first group of non-exposed and a second exposed to a health education campaign. this second group was encouraged to perform an exercise programme and given a 'suiprevention-treatment' brochure, approved by the regional health authority. results: sui prevalence was . %( %ci: . - . ) before pregnancy, . %( %ci: . - . ) during pregnancy and . ( %ci: . - . ) four weeks after birth. less than half of the women with sui sought help from healthcare professionals. statistical significant differences were found between groups: sui knowledge level and practice of pelvic floor muscles re-education exercises were higher in the exposed group ( . and . times, respectively). conclusions: sui affects a great number of women but only a small percentage reveals it. this campaign improved women knowledge and modified their else behaviors. healthcare professionals must be aware of this reality, providing an early and continuous intervention that would optimise the verified benefits of this campaign. abstract background: social inequalities have been associated with poorer developmental outcomes, but little is known about the role of the area of residence. objectives: examine whether the housing infrastructure of the area modifies the effect of socio-economic conditions of the families on child development. design and methods: community-based survey of under-fives in southern brazil applied hierarchical multi-level linear regression to investigate determinants of child development, measured by a score from the denver developmental screening test. results: in multivariable models, the mean score of child development increased with maternal and paternal education and work qualification, family income and better housing and was higher when the mother was in paid work (all p< . ). paternal education had an effect in areas of lower housing quality only; the effect of occupational status and income in these areas were twice as large as in better-provided areas (likelihood test for all interactions p< . ). this model explained % of the variation in developmental score between the areas of residence. conclusion: the housing quality and sanitation of the area modified the effects of socioeconomic conditions on child development. discussion: housing and sanitation programs are potentially beneficial to decrease the negative effect of social disadvantage on child development. abstract background: it is known that both genetic and environmental factors are involved in the early development of type diabetes (t d), and that incidence varies geographically. however we still need to explain why there is variation in incidence. objectives: in order to better understand the role of non-genetic factors, we decided to examine whether prevalence of newborns with high risk genotypes or islet autoantibodies varies geographically. design and methods: the analysis was performed on a cohort of newborns born to non-diabetic mothers, between september and august , who were included in diabetes prediction in ska˚ne study (dipis) in sweden. neighbourhoods were defined by administrative boundaries and variation in prevalence was investigated using multi-level regression analysis. results: we observed that prevalence of newborns with islet autoantibodies differed across the municipalities of ska˚ne (s = . , p < . ), with highest prevalence found in wealthy urban areas. however there was no observed difference in the prevalence of newborns with high risk genes. conclusion and discussion: newborns born with autoantibodies to islet antigens appear to cluster by region. we suggest that non-genetic factors during pregnancy may explain some of the geographical variation in the incidence of t d. abstract background: risk assessment is a science-based discipline used for decision making and regulatory purposes, such as setting acceptable exposure limits. estimation of risks attributed to exposure to chemical substances are traditionally mainly the domain of toxicology. it is recognized, however, that human, epidemiologic data, if available, are to be preferred to data from laboratory animal experiments. objectives: how can epidemiologic data be used for (quantitative) risk assessment? results: we described a framework to conduct quantitative risk assessment based on epidemiological studies. important features of the process include a weight-of-theevidence approach, estimation of the optimal exposure-risk function by fitting a regression model to the epidemiological data, estimation of uncertainty introduced by potential biases and missing information in the epidemiological studies, and calculation of excess lifetime risk through a life table to take into account competing risks. sensitivity analyses are a useful tool to evaluate the impact of assumptions and the variability of the underlying data. conclusion and discussion: many types of epidemiologic data, ranging from published, sometimes incomplete data to detailed individual data, can be used for risk assessment. epidemiologists should better facilitate such use of their data, however. abstract background: high-virulence h. pylori (hp) strains and smoking increase the risk of gastric precancerous lesions. its association with specific types of intestinal metaplasia (im) in infected subjects may clarify gastric carcinogenesis pathways. objectives: to quantify the association between types of im and infection with highvirulence hp strains (simultaneously caga+, vacas and va-cam ) and current smoking. design and methods: male volunteers (n = ) underwent gastroscopy and completed a self-administered questionnaire. participants were classified based on mucin expression patterns in biopsy specimens (antrum, body and incisura). hp vaca and caga were directly genotyped by pcr/reverse hybridization. data were analysed using multinomial logistic regression (reference: normal/superficial gastritis), models including hp virulence, smoking and age. results: high-virulence strains increased the risk of all im types (complete: or = . , %ci: . - . ; incomplete: or = . , %ci: . - . ; mixed: or = . , %ci: . - . ) but smoking was only associated with an increased risk of complete im (or = . %ci: . - . ). compared to non-smokers infected with lowvirulent strains, infection with the high-virulence hp increased the risk of im similarly for smokers (or = . , %ci: . - . ) and non-smokers (or = . %ci: . - . ). conclusion: gastric precancerous lesions, with different potential for progression, are differentially modulated by hp virulence and smoking. the risk of im associated with high-virulence hp is not further increased by smoking. abstract background: in may , the portuguese government created the basic urgency units (buu). these buu must attend at least . persons, be open hours per day, and be at maximum minutes of distance to all the users. objectives: determine the optimal location of buu, considering the existing health centers, in the viseu district, north portugal. methods: from a matrix of distances between population and health centers an accessibility index was created (sum of distances traveled by population to reach a buu). the location-allocation models were used to create simulations based on p-median model, maximal covering location problem (mclp) and set covering location problem (sclp). the solutions were ranked by weighting the variables of accessibility ( %), number of doctors in the health centers ( %), equipments ( %), distance/time ( %) and total number of buu ( %). results: the best solution has buu, doctors, attends users and the accessibility index is . km. conclusions: it was proved that it is impossible to attend all the criterion for creation of a buu. in some areas with low population density, to sum at least persons in a buu, the travel time is necessarily more than hour. background: a prospective observational study of fatigue in staff working a day/ off/ night/ off roster of hour shifts was conducted at a fly-in/fly-out fertilizer mine in remote northern australia. objectives: to determine whether fatigue in staff increased: from the start compared to the finish of shift; with the number of consecutive shifts; and from day-compared to nightshift. methods: data of sleep diaries, the mackworth clock test and the swedish occupational fatigue inventory were obtained at the start and finish of each shift from august to november . results: a total of staff participated in the study. reaction times, sleepiness and lack of energy scores were highest at the finish of nights to . the reaction times increased significantly at both the start and finish of day onwards, and at the finish of night . reaction times and lack of motivation were highest during nightshift. conclusions: from the above results, a disturbed diurnal rhythm and decreased motivation during night-shift; and a roster of more than eight consecutive shifts can be inferred as the primary contributors to staff fatigue. discussion: the implications for changes to workplace practices and environment will be discussed. the aim of this survey was to assess the impact of a meta-analysis comparing resurfacing with nonresurfacing of the patella on the daily practice of experts. participants in this study were experts which had participated in a previous survey on personal preferences regarding patella resurfacing. these experts in the field of patella resurfacing were identified by a thorough search of medline, an internet search (with googletm search engine), and personal references from the identified experts. participants of the 'knee arthroplasty trial' (kat) in the united kingdom were also included. two surveys were sent to the participants, one before and one after the publication of the meta-analysis. the response rate is questionnaires or %. the vast majority of responders are not persuaded to change change their practice after reading the metaanalysis. this is only in part due to the fact that best evidence and practice coincide. other reasons given are methodology related, an observation which is shared by the authors of the review, which force the orthopedic community to improve its research methodology. reasons such as 'i do not believe in meta-analysis' either demands a fundamental discussion or demands the reader to take evidence based medicine more seriously. abstract background: patients with type diabetes (dm ) have a - fold increased risk of cardiovascular disease. delegating routine tasks and computerized decision support systems (cdss) such as diabetes care protocol (dcp) may improve treatment of cardiovascular risk factors hba c, blood pressure and cholesterol. dcp includes consultation-hours exclusively scheduled for dm patients, rigorous delegation of routine tasks in diabetes care to trained paramedics, and software to support medical management. objective: to investigate the effects of dcp, used by practice assistants, on the risk of coronary heart disease for patients with dm . design and methods: in an open-label pragmatic trial in general practices with patients, hba , blood pressure and cholesterol were examined before and prospectively one year after implementation of dcp. the primary outcome was the change in the year ukpds coronary heart disease (chd) risk estimate. results: the median year ukpds chd risk estimate improved significantly from . % to . %. hba decreased from . % to . %, systolic blood pressure from . to . mmhg and total cholesterol from . to . mmol/l. (all p< . ). conclusion: delegating routine task in diabetes care to trained paramedics and using cdss improves the cardiovascular risk of dm patients. tuberculosis in exposed immigrants by tuberculin skin test, ifn-g tests and epidemiologic abstract background: currently immigrants in western countries are only investigated for active tuberculosis (tb) by use of a chest x-ray. recent latent tuberculosis infection (ltbi) is hard to diagnose in this specific population because the only available test method, the tuberculin skin test (tst), has a low positive predictive value (ppv). recently interferon-gamma (ifn-g) tests have become available that measure cellular responses to specific m. tuberculosis antigens and might have a better ppv. objective: to determine the predictive value of tst and two different ifn-g tests combined with epidemiological characteristics for developing active tb in immigrants who are close contacts of smear positive tb patients. methods in this prospective cohort study close contacts will be included. demographic characteristics and exposure data are investigated. beside their normal examination they will all have a tst. two different ifn-g tests will be done in those with a tst induration of ? mm. these contacts will be followed for years to determine the occurrence of tb. results since april , municipal health services have started with the inclusion. preliminary results on the predictive value of tst, both ifn-g tests and epidemiological characteristics will be presented. abstract background: different factors contribute to the quality of ed (emergency department) care of an injured patient. objective: determine factors influencing the disagreement between er diagnoses and those assigned at hospital admission in injuried patients, and evaluate if disagreement between the diagnoses could have worsened the outcome. methods: all the er visits of the emergency departments of lazio region for unintentional injuries followed by hospitalisation in . concordant diagnoses were established on the basis of the barell matrix cells. logistic regression was used to assess the role of individual and er care factors on the probability of concordance. a logistic regression where death within days was the outcome and concordance the determinant was uses. results: , injury er visits were considered. in . % cases, the er and discharge diagnoses were concordant. higher concordance was found with increasing age and less urgent cases. factors influencing concordance were: the hour of the visit, er level, initial outcome, length of stay in hospital. patients who had non concordant diagnoses had a % higher probability of death. conclusions: a correct diagnosis at first contact with the emergency room is associated with lower mortality. methods: a cohort of consecutive patients treated for secondary peritonitis were sent the posttraumatic stress syndrome inventory (ptss- ) and impact of events scale-revised (ies-r) - years following their surgery for secondary peritonitis. results: from the patients operated upon between and , questionnaires were sent to the long-term survivors of which % responded (n = ). ptsd-related symptoms were found in % of patients by both questionnaires. patients admitted to icu (n = ) were significantly older, with higher apache-ii scores, but reported similar ptsd symptomology scores compared to non-icu patients (n = ). traumatic memories during icu and hospital-stay were most predictive for higher scores. adverse memories did not occur more often in the icu group than in the hospital-ward group conclusions: longterm ptsdrelated symptoms in patients with secondary peritonitis were very barthé lé my c cabanas ruiz-carrillo de la cruz den boon jimé nez-moleó n mü ller-nordhorn national evaluation team rich-edwards in the netherlands. design and methods we used the populationbased databases of the netherlands cancer registry, the eindhoven cancer registry (ecr) and the central bureau of statistics. patients from the ecr were followed until - - for vital status and relative survival was calculated. results: the number of breast cancer cases increased from in to . in , an annual increase of . % (p< . ). the death rate decreased , % annually (p< . ), which resulted in deaths in . the relative -yr survival was less than % for patients diagnosed in the seventies, this increased to over % for patient diagnosed since , patients with stage i disease even have a % -yr relative survival. conclusion: the alarming increase in breast cancer incidence is accompanied with a serious improvement in survival rates. this results in a large number of women (ever) diagnosed with breast cancer, about , in of whom % demand some kind of medical care. abstract background: nine % of the population in the netherlands belongs to non-western ethnic minorities. perceived health is worse and health care use different from dutch natives. objectives. which factors are associated with ethnic differences in self-rated health? which factors are associated with differences in utilisation of gp care? methods: during one year all contacts with gps were registered. adult surinam, antillean, turkish, moroccan and dutch responders were included (total n: . ). we performed multivariate analyses of determinants of self-rated health and on the number of contacts with gps. results: self-rated health differ from native dutch: surinam/antillean (or . ) and turkish/moroccan patients (or . / . ) , especially in turkish/moroccan females. more turks visit the gps at least once a year (or . ). less surinamese (or . ) and antillean patients (or . ) visit their gps than the dutch do. people from ethnic minorities in good health visit their gps more often ( . - . consults per year vs. . ). incidence rates of acute respiratory infections and chest complaints were significantly higher than in the dutch. conclusions: ethnicity is independently associated with self-rated health. higher use of gp-care by ethnic minorities in good health, points towards possible inappropriate use of resources. the future: do they fulfil it? first results of the limburg youth monitoring project abstract background: incidence of coronary heart disease (chd) and stroke can be estimated from local, population-based registers. it is unclear, to what extent local register data are applicable on a nationwide level. therefore, we compared german register data with estimates derived with who global burden of disease (gbd) method. methods: incidence of chd and stroke was computed with the gbd method using official german mortality statistics and prevalences from the german national health survey. results were compared to estimates from the kora/monica augsburg register (chd) and the erlangen stroke project in southern germany. results: gbd estimates and register data showed good agreement: chd (age group - years) , (gbd) versus , (register) and stroke (all ages) , versus , incident cases per year. chd incidence among all age groups was estimated with the gbd method to be , per year (no register data available). chd incidence in men and stroke incidence in women were underestimated with the gbd method as compared to register data. conclusions: gbd method is a useful tool to estimate incidence of chd and stroke. the computed estimates may be seen as lower limit for incidence data. differences between gbd estimates and register data are discussed. abstract background: children with mental retardation (mr) are a vulnerable not much studied population. objectives: to investigate psychopharmacotherapy in children with mr and to examine possible factors associated with psychopharmacotherapy. methods: participants were recruited through all facilities for children with mental retardation in friesland, the netherlands, resulting in participants, - years old, including all levels of mental retardation. the dbc and the pdd-mrs were used to assess general behavior problems and pervasive developmental disorders (pdd). information on medication was collected through a parent-interview. logistic regression was used to investigate the relationship between the psychotropic drug use and the factors dbc, pdd, housing, age, gender and level of mr. results: % of the participants used psychotropic medication. main factors associated with receiving psychopharmacotherapy were pdd (or . ) and dbc score (or . ). living away from home and mr-level also played a role whereas gender and age did not. dbc score was associated with clonidine, stimulants and anti-psychotics. pdd was the main factor associated with anti-psychotics use (or . ). discussion: psychopharmacotherapy is especially prevalent among children with mr and comorbid pdd and general behavior problems. although many psychotropic drugs are used off-label, specific drugs were associated with specific psychiatric or behavior problems. abstract background: increased survival in children with cancer has raised interest on the quality-of-life of long-term survivors. objective: to compare educational outcomes of adult survivors of childhood cancer and healthy controls. methods: retrospective cohort study including a sample of adult survivors ( ) treated for childhood cancer in the three existing italian paediatric research hospitals. controls ( ) were selected among siblings, relatives or friends of survivors. when these controls were not available, a search was carried out in the same area of residence of the survivors though random digit dialling. data collection was carried out through a telephone-administered structured questionnaire. results: significantly more survivors than controls needed school support (adjusted odds ratio -oradj- . , % ci . - . ); failed at least a grade after disease onset (oradj . , % ci . - . ); achieved a lower educational level (oradj . , % ci . - . ) and did not reach an educational level higher than their parents' (oradj . , % ci . - . ). subject's age, sex, parents' education and area of residence were taken into account as possible confounders. conclusions: these findings suggest the need to provide appropriate school support to children treated for childhood cancer. abstract background: in italy supplementation with folic acid (fa) in the periconceptional period to prevent congenital malformations (cms) is quite low. the national health institute has recently launched ( ) a programme to improve awareness about the role of fa in reducing the risk of serious defects also by providing . mg fa tablets free of charge to women planning a pregnancy. objectives: we analysed cms that are or may be sensitive to fa supplementation in order to establish an adequate baseline to allow a fa impact assessment in the next years and to investigate spatial differences among cms registries, time trends and time-space interactions. design and methods data collected over - by the italian registries members of eurocat and icbdsr on births and induced abortions with neural tube defects, ano-rectal atresia, omphalocele, oral clefts, cardiovascular, limb reduction and urinary system defects. results: all the cms showed statistically significant differences among registries with the exception of ano-rectal atresia. the majority of cms by registry showed stable or increasing trends over time. conclusions results show the importance of fa intake during the periconceptional period. differences among registries indicate also the need of having a baseline for each registry to follow trends over time. abstract country-specific resistance proportions are more biased by variable sampling and ascertainment procedures than incidence rates. within the european antimicrobial resistance surveillance system (earss) resistance incidence rates and proportions can be calculated. in this study, the association between antimicrobial resistance incidence rates and proportions and the possible effect of differential sampling of blood cultures was investigated. in , earss collected routine antimicrobial susceptibility test data from invasive s. aureus isolates, tested according to standard protocols. via a questionnaire denominator information was collected. the spearman correlation coefficient and linear regression were used for statistical analysis. this year, of hospitals and of laboratories from of earss countries responded to the questionnaire. they reported of, overall, , s. aureus isolates. in the different countries, mrsa proportions ranged from < % to % and incidence rates per , patient days from . ae - to . ae - . overall, the proportions and rates highly correlated. blood culturing rates only influenced the relationship between mrsa resistance proportions and incidence rates for eastern european countries. in conclusion, resistance proportions seem to be very similar to resistance incidence rates, in the case of mrsa. nevertheless, this relationship appears to be dependent of some level of blood culturing. . key: cord- -n gk xhb authors: kickbusch, ilona title: policy innovations for health date: - - journal: policy innovation for health doi: . / - - - - _ sha: doc_id: cord_uid: n gk xhb we are at a turning point in health policy. it has become increasingly clear that changes in the existing health care system will not be sufficient to maintain and improve our health at this historical juncture. both our extensive knowledge on what creates health as well as the exponentially rising rates of chronic disease obesity, and mental health problems indicate that we need to shift course and apply a radically new mind-set to health and health policy. this is what we mean by policy innovations for health. the boundaries of what we call the “health system” are becoming increasingly fluid and health has become integral to how we live our everyday life. health itself has become a major economic and social driving force in society. this shifts the pressure for policy innovation from a focus on the existing health system to a reorganization of how we approach health in st century societies. the dynamics of the health society challenge the way we conceptualize and locate health in the policy arena and the mechanisms through which we conduct health policy. they also redefine who should be involved in the policy process. this concern is beginning to be addressed within government through health in all policy approaches and beyond government through new partnerships for health. most importantly, the role of citizen and patient is being redefined – a development that will probably lead to the most significant of the policy innovations for health in the st century. innovation is something everyone wants more of, but nobody is too sure what it means exactly. john gapper [ ] innovation for the authors of this book is about applying a radically new mindset to health and health policy with the goal of addressing the determinants of health and involving citizens in their health in new ways. this explains our choice of terminology: policy innovations for health. we start from a perspective that considers both health and innovation to be central driving forces in st century societies, and we maintain that their prominent role reflects major societal shifts that are under way. the consequence is not only a changing role of health in modern societies but also a new perception of innovation in relation to health. as part of this change we see new mechanisms emerge which aim to address the seminal changes underway in health and society. the shift from the industrial society of the th and th centuries to the knowledge societies of the st century is as ground-breaking as was the shift from the agrarian to the industrial world -and they are similar in their deep impact on health, this increases the need for innovation. the changes in our way of life are shaping our lifestyles and have created a situation where many of the patterns of everyday life -for example, our eating and food shopping patterns -and new forms of social stratification -for example, new forms of social inclusion and exclusion -endanger our health. this means that we need to understand that the health challenges and the diseases that come with this change are of a larger societal, not an individual nature. it seems obvious that this development has two consequences: it changes the role of the health care sector significantly toward managing chronic disease rather than acute care and it moves many of the solutions for the most challenging health problems into other social and policy arenas. the authors of this book are focused on the second challenge and the policy mechanisms that are needed to address it. the need for change is vast. first, there is hardly a policy sector that can be excluded: health, education, agriculture, transport, industry, consumer affairs, and sports -all are essential to support health. second, in a consumer society the role of business is critical and consumers themselves must express their demand. finally, communities must act for their health interest and individuals are required to support their individual health and that of their families in new ways. to do so they need to be able to negotiate and navigate an increasingly complex health and care environment. a recent analysis concerned with innovation and high performing health systems [ ] underlines that there are two goals of innovation in relation to health: improving the affordability, quality, and efficiency of the health care system and improving the health of populations. ideally the two would be fully complementary -in the real world they are not. usually when we speak of innovation in the context of health the automatic assumption is that we mean the expansion of therapeutic possibilities -we associate new medicines, new technologies, and increasingly the potential of biomedicine and genetics. sometimes we think of new approaches to the organization and financing of the medical care system, then we typically speak of "health care reform" -a term that is now linked almost exclusively with efficiency, effectiveness, and cost saving. the words innovation and health policy do not by and large sit very well together because the notion of "newness" and "better" that is at the core of innovation has been overshadowed by many short-term reorganizations of health care systems that seem to lack in vision and long-term perspective. and, if innovation is considered in terms of radical innovation only then we experience a clear tension between the drive for innovation and the constant challenge to keep down health care expenditures. a recent health innovation survey by the oecd [ ] typically focuses on the "question how to encourage and foster innovation which addresses health needs and priorities, maximizes access to benefits, and manages challenges and risks in a way that is beneficial to both innovators and health systems." innovation in this case is also mainly related to innovations in biotechnology and the key challenge is how oecd countries are able to cope with introducing such technical and product-based innovations into their respective health care systems. this focus on financial pressure has led -through a range of new assessment mechanisms -to a reinforcement of a binary understanding of innovation as being either radical or incremental and a focus on medical rather than social value. over the last decade we have begun to witness a major shift with regard to health and its role in society. i argue that we now live in a health society which is characterized by two major social processes: the expansion of the territory of health and the expansion of the reflectivity of health [ ] . the creation of the health society of the st century has been a process long in the making, beginning from about the mid th century onward. health is integral to modernity and our modern societies would not be possible without the health gains achieved in this -year period [ ] . during this time the balance of power between the four domains of the health systempersonal health, public health, medical health, and the health market -has shifted continuously. the domains of personal health and public health dominated the th and th centuries, while during the th century the medical health domain gained increasing strength both in terms of its power over the social definition of health and the dominance of its organizational and governance infrastructure; this process of dominance has been referred to as medicalization. as a consequence, in both political and public perceptions, the social organization of health resides in what we have come to call the health care system and concerns over how to ensure the long-term financial sustainability of this system dominate the health policy debate. but today the boundaries of what we call the "health care system" are becoming increasingly fluid. health has become integral to how we live our everyday life. in this health is similar to innovation, which is also increasingly defined as being fluid, an issue that will be reflected upon later in this chapter. indeed the expansion and liquidity of boundaries is a major characteristic of what the sociologist zygmunt bauman calls "liquid modernity" [ ] . this changes the health policy debate because it means that health is everywhere: every policy decision a government makes also impacts on health and at the individual level every behavioral choice also has a health consequence. this was always the case -but now it is part of reflective modernity. most discussions on health policy do not yet take this deep seminal change into account -they still focus on tinkering with a well-defined functional system of health governance, where through a process of defining the evidence base, they aim to ensure clear boundaries, define interventions, and prioritize medical rather than social solutions. the authors of this book are of the opinion that we clearly need a policy approach that responds more adequately to the new environment of st century health. the dynamics of the health society not only challenge the way we conceptualize and locate health and how we conduct health policy but they also redefine who should be involved in policy making -together they constitute policy innovations for health. the chapters of the book further explore five key defining concepts: . health is more than disease and health outcomes need to be measured differently; . the system boundaries are shifting and organization of health in society is increasingly separated from the management of disease and illness; . health policy is more than health care policy and becomes a joined up process of health in all policies at all levels of governance; . the differentiation into a first and second health market is occurring rapidly and we are faced with new issues of financing both health and health care; . people themselves are major actors in the health arena and new technologies are allowing them to participate in completely new ways. many analysts make the point that the changes facing the health sector will be as phenomenal as those we have witnessed in information technology and communications. this is due to the fact that health itself has become a major economic and social driving force in society [ ] and that good health outcomes are increasingly important for a range of societal goals. the conference board of canada [ ] suggests understanding innovation "as a means by which societies, systems or organizations achieve social or economic value (e.g. increasing positive health outcomes)"; they maintain that innovation occurs only when new value is created. our focus in this book is to explore what kind of policy innovations for health are required to achieve better population health, in terms of both its social and economic value. we argue though that the issue at stake is not just another reorganization/improvement of the health care system or a better mechanism of integrating scientific progress into existing heath care systems but a reorganization of how we approach health in st century societies. in this we follow peter drucker's understanding of innovation as creating a new dimension of performance [ ] . in modern democracies health is considered a right. its doability is driven by the perception that health can be created, managed, and produced: more health is always possible. it is one of the characteristics of the health society that the notion of doability has expanded beyond the ever-rising expectations toward the curative medical care system to impact the determinants of health. the first conceptual starting point for the arguments in this book are the rapidly changing determinants of health. we build on the arguments for increasing the investment for health and well-being and for strengthening the connection between health and wealth which are beginning to be expressed far beyond the public health community. witness the similarity of the statements from the public health perspective as voiced by wilkinson and marmot [ ] , two of the most respected researchers on social determinants of health good health involves reducing levels of educational failure, reducing insecurity and unemployment and improving housing standards. societies that enable all citizens to play a full and useful role in the social, economic and cultural life of their society will be healthier than those where people face insecurity, exclusion and deprivation and as expressed in a recent publication commissioned by the european commission [ ] ...improving the health status of a population can be beneficial for economic outcomes at the individual and the national level. there is indeed much evidence to suggest that the association between economic wealth and health does not run solely from the former to the latter. an immediate, if general, policy implication that derives from this conclusion is that policy-makers who are interested in improving economic outcomes (e.g. on the labour market or for the entire economy) would have good reasons to consider investment in health as one of their options by which to meet their economic objectives. it follows that if societies are to prepare adequately for new health challengessuch as obesity -and if they are to take action on the changes already under way, they must completely rethink their approach to health policy. it is argued that health sustainability is as important as environmental sustainability and that our response must be understood to be the challenge of at least a generation [ ] . we need policy innovations for health that address the classic determinants of health, such as education, work, housing, transport, and particularly equity. some countries -such as sweden -have now done so and this is discussed in more detail in the chapters that follow [ ] . the "classic" determinants of health continue to influence our health. the determinants of health however, in the boundaryless health landscape of the st century policy innovations are called for that respond to the st century determinants of health. health is increasingly being shaped by forces such as the speed of modern societies, globalization of markets, the increasing mobility and insecurity of individuals, energy expenditure, and concerns regarding risk and safety, and the reach of the media. these forces cut across many of the acknowledged social, environmental, and economic determinants of health. an approach to visualize the many determinants and their interaction was developed by the well-being project, scotland, in a joint effort with members of the community [ ] . the second conceptual starting point for the authors of this book is an understanding of health which is social rather than a medical. health governance is now challenged by this conceptualization of health as "well being beyond the absence of disease" as first defined by the world health organization in its constitution [ ] . the ottawa charter of the who [ ] stated that "health is created in the context of everyday life -where people live, love, work, learn and play," and this has found its expression in a wealth of health promotion activities at organizational, community, and local level. the most well known are the many "settings projects," which aim to create supportive environments for health and encourage people to participate in shaping these settings for everyday life, examples include healthy cities, healthpromoting schools, and healthy workplaces [ ] . indeed they constitute social innovations that spread the new understanding of health into many different sectors and, as an activity in the space between the sectors, prepare the ground for policy innovations and their social acceptance [ ] . recent global happiness surveys have identified health next to wealth and education as one of the three key factors for societal well-being [ ] . health becomes more central for the aspiration of personal goals in life and social inequalities are increasingly measured in health terms, highlighting differences in health and life expectancy. this broader view of health also needs to be reflected in the way we measure the impact of policy innovation for health. hernandez-aguada, in his chapter, discusses the increasing relevance of new types of health intelligence for intersectoral health governance with a particular focus on transparency and accountability for all actors in society. one such example of measurement, the canadian index of well-being [ ] , clearly illustrates the dimensions of innovation that a new type of health policy needs to address: • build a foundation to articulate a shared vision of what really constitutes sustainable well-being; • measure national progress toward, or movement away from, achieving that vision; • understand and promote awareness of why society is moving in the direction it is moving; • stimulate discussion about the types of policies, programs, and activities that would move us closer and faster toward achieving well-being; • give canadians tools to promote well-being with policy shapers and decision makers; • inform policy by helping policy shapers and decision makers to understand the consequences of their actions for canadian well-being; • empower canadians to compare their well-being both with others within canada and those around the world; and, • add momentum to the global movement for a more holistic way of measuring societal progress. policies must come to terms with the new forces that act to create or compromise health -they must respond to what has been called "the new personal health ecology" where the individuals are subject to a broad range of influences over which they have very little control [ ] . just as cholera was symptomatic for all the dimensions of the rapid urbanization of the th century, obesity is the symbolic disease of our global consumer society. it will be a test case for the health governance of the st century as was the introduction of water and sewage systems at the end of the th century. such challenges can only be resolved through great political commitment, willingness to innovate, and social action -including social entrepreneurship -at all levels of society. health and innovation are both social constructs, defined by their time and context. just as the concept of health is changing, so is the concept of innovation. the social sciences began in the s to concern themselves with both health and innovation as distinct areas of social analysis. it was at this point that both medical sociology (later to become health and medical sociology) and the sociology of innovation began to advance -the one never far removed from medicine, the other never far from the sociological analysis of technological development. even today much of the literature on innovation still comes from a science and technology perspective. this is in sharp contrast to economics, where already at the beginning of the th century josef schumpeter drew attention to innovation as the engine of social and economic development, highlighting both its power of creation and of destruction [ ] . health has now become such an innovation engine -many investors see health as "the next big thing" and a rapidly growing health market attaches the added value "health" and well-being to an ever-growing set of products and services. the chapter by henke and martin in this book illustrates this process: not only do health innovations change society, but through the societal process of innovation in health the very nature and the characteristics of innovation change, a process that has been described as "the innovation of innovation." this leads further to the concepts of "open innovation" and "fluid innovation," which are discussed further below in relation to policy innovations for health [ ] . in switzerland a recent survey asked a group of health experts to identify the key technological and social drivers of innovation in health [ ] . in the first category the experts established a ranking in the following order: ( ) developments in biotechnology and genetics, ( ) medical technology, ( ) informatics and soft ware, ( ) organic chemistry, ( ) telecommunications and ( ) nano technology. in the second category they ranked ( ) demography, ( ) individual responsibility, ( ) nutrition, ( ) education, and ( ) income distribution. most interesting though -and symptomatic for the speed of social change -is that the experts ranked the social driving forces as more important and forceful than the technological ones. additionally they did not assign a high impact value to political driving forces -which reflects the assumption of the experts, that not much innovation is to be expected from traditional types of health policy. the sociology of innovation argues that innovation itself has become a leitmotif of st century society; this development is called "ubiquitous innovating" [ ] . indeed if one refers to some of the key documents -for example, of the european union or of the oecd -a strategy for innovation is considered essential in order to compete in a global environment [ , ] . it is interesting -with a view to liquid modernity -how similar the discussion of a new conceptualization of innovation is to the discussion on a new understanding of health. health in turn is increasingly seen as one of the cornerstones for competitiveness and innovation. and like innovation it is increasingly seen to be in need of a policy approach that is more concerned with sustainability and long-term effects. the key health sustainability challenges of st century societies are: . the demographic and financial pressure brought to bear on health and social systems through the ageing of societies -societies need to support an increase in healthy life expectancy and an independent life, despite disability and chronic disease; otherwise, we might witness a breakdown of support systems and social solidarities. . in view of new epidemiological developments -for example, the increase of overweight and obesity, early onset of diabetes, and an increase in mental health problems -the generation of children born at the turn of the st century could be the first to have a lower health and life expectancy than their parents. increased investment in the health of the next generation is critical. . health systems organization and financing is not sustainable without major reorientation away from acute care toward increased prevention, management of chronic disease, and community-based, integrated primary health care. . with globalization we are witnessing the rapid spread and emergence of new infectious diseases -such as sars and hiv aids -and the re-emergence of others, such as tuberculosis, there is increasing fear of a global influenza pandemic -increased preparedness is critical at all levels of health governance. . as st century societies are restructuring they are presently witnessing increasing health inequalities -addressing these widening gaps will be a key challenge for trust in modern democracies. . we are only just beginning to understand the health impacts of global warming and climate change -we must be more conscious of the interdependence of health sustainability and environmental sustainability [ ] . while the territory of the medical system can be relatively clearly circumscribed and framed in terms of delivery and utilization of health care services, the territory of health becomes ever less tangible and increasingly virtual. disease has boundaries; health does not. the new health challenges make this blatantly obvious. within government the stakeholders in the response to obesity are not only the health ministry, but, for example, the ministries of transport, education, agriculture, trade, and consumer affairs. outside of government the producers of unhealthy food and drink products are as much in focus as are the settings of everyday life where they are consumed (such as canteens), global marketing and advertising practices, the media messages, and the role model celebrities to name but a few. smoking acts regulate not only who can buy tobacco products, where, and at what price but they define where it is permitted to smoke; in consequence, owners of bars and restaurants, retailers, and the management of airports and railway lines to name but a few, all need to be concerned with health in ways they were not before. consumers and voters as well as a wide array of health action groups and patient organizations make their preferences heard. this infinite nature of health has consequences for all four domains of the health system. it is specific to the health society that all four domainspersonal health, public health, medical health,and the health market -not only continue to change and expand but -and this is critical -that the balance between the systems is shifting [ ] . the health sector -consisting of the public health domain and the medical health domain -struggles to include more health, in the form of strengthening public health, health promotion, and prevention. yet, this approach is falling short in many countries, in particular for lack of political support, except where the measures are clearly medical, such as expanding screening or strengthening predictive medicine. while the new paradigms in preventative medicine are gaining increasing acceptance, public health measures are considered unduly paternalistic and are seen to impinge on the individual freedom of choice. structural measures addressing the determinants are also not politically popular, as they usually impinge on one or the other economic interest. there have been excellent policy documents such as the wanless report in england [ ] that have proposed to embark on an organizational shift within the health sector toward public health, driven in particular by the fear generated by the relentless growth of the medical health domain. they argue that more money needs to be invested in prevention, health promotion, and public health; otherwise, our societies will not be able to afford the constant expansion of the medical health system. so far within the health sector very few policies, institutions, organizations, and funding streams have clearly differentiated between investing for health and the expenditures for providing medical care. durand-zalesky makes this point in great detail in the contribution to this book and she underlines how important the political innovation environment is for a public health agenda focused on determinants -in the case of policy innovation for health the different perceptions of the role of the state, the market and the individuals are critical. where an accounting for health -which is different from the proposed national health accounts -is attempted, countries rarely reach more than a . % average of the overall "health" budget for prevention, health promotion, and public health, as oecd data tell us [ ] . politically the pressure is strong to subject every penny of this paltry amount to critical evidence reviews based on a medical mind-set, while to this day most health service organizations are still not accountable for their health outcomes and demonstrate a severe lack of transparency for patients and consumers. it is therefore arguable whether the expansion of a traditional public health approach -for example, with more funding -will be sufficient. a new nordic initiative argues -as do the authors in this book -that fundamentally new perspectives are needed. they locate them at three levels: mind-set, partnerships, and platforms [ ] . policy innovations for health need to move beyond the established functional boundaries of both the medical health domain and the public health domain. the innovation debate can help in conceptualizing the necessary change. open innovation is a term initially developed for the private sector and championed the idea that companies cannot anymore rely on their own innovative capacity -they need to share and outsource [ ] . the perception of open innovation now means to involve a broad range of partners in order to find innovative solutions, particularly in the form of innovation clusters. as used to be the case in business, the functional and hierarchical approach in the medical and the public health domains do not usually allow for this. there are therefore very few policy mechanisms that allow decision makers to consider both health determinants and health impacts in an integrated manner and to approach the new health challenges with joined up policy responses, initiatives, and interventions. usually each policy (sub) domain works to its own logic and intentions without regard for the impact on other areas of society or its global impact. some exceptions can be found in the area of environmental policies. if -with health in mind -we are willing to see the glass as half full, we can identify a range of policy innovations emerging in health that could be summarized under the term network governance. examples are described in more detail in the chapter by warner in this book. in many countries a first step to engage a broad range of actors around common goals was the development of health targets [ ] , an approach that gained ground from the s onward. in order to achieve the targets it became clear that policies in the health sector needed to be complemented by other sectors of government and that they in turn needed to be supported by policy commitments at different levels of government and in the private and nongovernmental sector. the wanless report calls this the fully engaged scenario [ ] . in consequence a new type of policy mix is emerging between governmental measures, global initiatives, local action, consumer pressure and demand, and mechanisms -such as self-regulation or corporate social responsibility approaches -put into place by companies and the private sector. who would have imagined even a decade ago a range of the policy innovations for health we have witnessed recently: • that a country would base its health policy on the determinants of health as in sweden? • that a health minister would regulate the body mass index of fashion models as in spain? • that television advertising of fast foods to children would be severely restricted as in england? • that a country could accept a total ban on smoking in public places -including restaurants and bars as in ireland? the health society not only means that health is present in every dimension of life, it also implies that risk is everywhere. as every place, setting, product or message in society can support or endanger health the potential stakeholders in any health policy decision expand exponentially; transport policies relate to the obesity epidemic, the beer tax influences young people's alcohol consumption and low literacy increases health inequalities. three types of policy innovations for health that qualify as open innovations are briefly outlined in the following: health in all policies, innovation clusters, and platforms. a key policy innovation for health is the health in all policies approach put forward by the finnish presidency of the european union in [ ] and first developed in the ottawa charter with the term "healthy public policy" [ ] . health in all policies is now also one of the four principles of the european health strategy of the ec [ ] . i have described health in all policies as an innovative policy strategy that responds to the critical role that health plays in the economies and social lives of st century societies. it introduces better health (improved population health outcomes) and closing the health gap as shared goals across all parts of government and addresses complex health challenges through an integrated policy response across portfolios. by incorporating a concern with health impacts into the policy development process of all sectors and agencies, it allows government to address the key determinants of health in a more systematic manner, while taking into account the benefit of improved population health for the goals of other sectors [ ] . some countries have tried to reflect such an approach by creating a ministerial mechanism for the focus on health rather than disease; for example, canada for a while had a minister for public health with cabinet rank, and england and sweden both have junior ministers for health. many partnerships are emerging beyond the health sector and its narrow policy conception. increasingly we see a wide range of innovation clusters developing which create a new type of interface between many different actors following the open innovation model for companies but expanding it into public-private partnerships. one such example "berlin's health care market" is described in this book in more detail by henke and martin. another example is the "myheart" project -which brings partners from countries together to develop "intelligent textiles" in order to prevent heart disease [ ] or the innovations in the area of functional foods. of particular interest as a policy innovation for health is the proposal to establish "the nordic region as a global health lab" [ ] . it is proposed that the nordic countries form an innovation cluster so that the nordic region will become "a global market leader for prevention solutions." they further state that "the booming global market for health related products and services speaks in favor of joint initiatives, where knowledge and experiences produced within a research framework can be used to develop products and solutions attractive to the nordic as well as the global market." they then go on to define the nine components that will give such an initiative a global competitive edge: nine components for success: . a social model supporting equal access to health for all . prevention as a top nordic policy priority . access to valuable data . strong civil society organizations . strong conditions for collaboration . innovative science environments . strong industries . a competitive nordic region . demanding consumers provide a strong platform for user driven innovations this initiative is a clear example of the attempt to build an innovation on a supportive policy environment in order to create social and economic value through health not only locally, but globally. another move toward policy innovations for health based on open innovation approaches is the ever increasing number of platforms, coalitions, alliances, and networks built around health issues. a good example is the european platform on diet, physical activity and health initiated in by the dg sanco of the european commission, which allows the commission to work with a wide range of players across the public, private, and nongovernmental sectors [ ] . the stated intent is to create a platform for concrete actions designed to contain or reverse current trends, platform members must commit to action. as underlined in the white paper on strategy for europe on nutrition, overweight and obesity related health issues, the commission considers that the development of effective partnerships must be the cornerstone of europe's response to tackling nutrition, overweight and obesity, and their related health problems. in such platforms the members agree to monitor and evaluate the performance of commitments in a transparent, participative and accountable way; the eu platform, for example, works to a founding member's statement, has a monitoring framework and produces progress reports. the visibility and legitimacy conferred through such alliances is gaining increasing importance as a policy mechanism as are a myriad of public-private partnerships. actors and issues gain prominence through media presentation and public debate as the health society is also a media-driven society. these platforms constitute a new political space for health and network governance, particularly for very controversial issues. the european commission, for example, uses a multistakeholder platform to address alcohol issues through an "alcohol and health forum," bringing together civil society and businesses pledging to take action to reduce alcohol-related harm in europe [ ] . innovation and knowledge are interdependent. innovation can be defined as the process through which social and economic value is created through knowledge, an issue discussed in more detailed in the chapter by sakellarides. this is done by different forms of knowledge creation, diffusion, transformation, and application. both health and innovation are increasingly dependent on the inclusion of the user and challenged by the democratization of knowledge production. the sociology of innovation describes the innovation paradox, which postulates that in the knowledge society the role of the producer and the role of the consumer move ever closer together -health as well as innovation therefore need to be considered as coproduced goods [ ] . in the area of technological innovation this is often described with terms like open source, open content, lead user, open innovation, collective invention, user innovation, and creative commons [ ] . in health policy this participatory element has been neglected. on the one hand it is particularly difficult for the health care system to accept participation, because it has been defined by a very strong hierarchy between the professional physician, other health professionals, and the patient. yet the management of chronic disease and the adherence to prevention regimes can only be achieved with full participation of the individual concerned. the overlap of unmet medical needs and unmet social needs can only be addressed jointly between patients, providers, and the social support system -patient input is a prerequisite to developing the kind of integrated disease-management models that most health systems still do not provide because they are out of step with the epidemiological and social development. the unmet medical and social need has led to the creation of a wide range of highly active patient organizations and self-help groups who act as the experts on "their" disease. the same applies to prevention and health promotion -the active participation of the individual, social groups, and communities is needed to engage in successful initiatives [ ] . sakellarides in his chapter highlights to interdependence of the knowledge society with innovation in the health society. patients want information, participation, and choices -this is the result of the "european patient of the future" survey from [ ] . consumers want simplicity, convenience, speed, and a good price [ ] . increasingly the two expectations meet as health systems become increasingly market driven and as patients want more say and have higher expectations. new products and technologies can only develop their full potential if they meet processes and structures that allow them to do so. this implies new forms of information, communication, and integration processes. the conference board of canada in its recent analysis [ ] defines three dimensions of high performing health systems: people and culture, technologies, and structure and processes. this is also reflected in the more recent literature on innovation which speaks of a paradigm shift toward a "fluid identity of innovation" [ ] . this means the "old" debates as to what constitutes a radical innovation and an incremental innovation is considered less and less relevant. this is often much more obvious in other, less regulated areas than the health sector. a good example from information technology is the telephone: at what point in the long process from graham bell's machine to the tiny multifunctional mobile instruments we use today do we speak of radical or incremental innovation? when it turned wireless? when it could take photographs? when it became the iphone? whatever it will be in future? similar questions arise in relation to medicines and medical technology which with the rise of chronic disease fulfill more than their primary medical function -they cannot cure any more so they will seek to reduce pain and the progress of disease, lengthen life, improve mobility, ensure independence, be easy to use, etc. the innovation process around medicines for hiv/aids is a typical case in point -every small improvement in the lives of aids patients counts and it continues to be driven not only by medical innovation but a very strong demand from influential user and advocacy groups. probably one of the most important process innovations that needs to be achieved lies in the transparency and accountability of health policy and health systems. hernandez-aguado in his chapter indicates how new types of monitoring could provide transparency and accountability for the impact that other sectors have on health. sakellarides and his coauthors highlight the significance of patient-driven and patient-owned health information, also including the determinants of health. it is indeed worrying that in modern democracies, citizens -once they become patients -do not have access to data on the performance of the system that they enter or even to their own health data. this knowledge-based value creation willas sakellarides states -probably be the most relevant health policy innovation in the next decade. health consumer powerhouse regularly publishes a ranking which indicates in which countries consumers and patients have the most rights and the most opportunities for participation [ ] . a recent german survey showed that most citizens would like to see a ranking of physicians and would like to see their medical bills. [ ] . if health is a coproduced good, then all those that participate in its production have a right to transparency of all elements of the process. the issue of transparency also arises around propriety regulations. in the information technology field, there has been a move toward open access, open source, and open standards, and with the expansion of the internet it has led to new forms of information access and sharing -the exciting mix of social and technological innovation, as reflected in platforms such as myspace and second life. these demand-push innovations have in turn led to highly profitable companies. due to the structure of the proprietary industry and government regulations, much of this innovation process remains closed. it is regularly challenged, in particular, by nongovernmental organization in relation to global health issues innovations -and more recently by the establishment of government assessment agencies. this conflict is not the subject of this book -yet it is worth referring to an interesting experiment at the world economic forum in , which discussed how the break down of proprietary rights in the entertainment industry could be a signal for the pharmaceutical industry to reconsider its approaches with a new and proactive demand-push approach. in some cases this has succeeded at the global level where new forms of pricing, patent policies, and financing of pharmaceutical innovation for diseases of the developing world have been developed, and after much conflict a new cooperation between advocacy groups, the industry, governments, and modern philanthropy has emerged. for this book the key issue is that health is no longer a given; it is produced, maintained, and enhanced. the results of health research are rapidly transported through the media -a new cure, a new method of prevention, a new confirmation of old behaviors, all have high currency in the health society. what is considered healthy today might not be so tomorrow -new risks continuously emerge [ ] . as a consequence heath literacy plays a critical role [ ] . risks are frequently not visible or seem intangible and they need to be well communicated, and above all understood and translated into action. as more and new health information becomes available this can become a difficult challenge for ordinary citizens in particular if they are not well educated or even functionally illiterate, as about % of all citizens in the oecd countries are. the expansion of health choices and the complexity of health systems demand an ever higher degree of sophistication and participation, and as a consequence there is a growing offer and demand not only for health information but for advice and knowledge brokering. to be a passive and compliant patient who follows the physician's instructions is no longer sufficient -particularly when related to preventative issues. indeed the emerging model is one of active and critical consumers, an ideal that only few members of the population can aspire to achieve. already today -despite the universal access to health care -health inequalities abound even in the richest countries, and there is a clear danger that they will widen even further as the health society expands. the very presence of health in all areas of everyday life can also lead to a variety of reactions -either to attempts to reach an unrealistic body image or to conscious risk taking in opposition to an overpowering set of health messages and expectations. while the health society offers many opportunities of empowerment, it can also be prescriptive and exert social control through health [ ] . within a health society there has to be constant democratic dialog about the societal value we attach to health, a debate that has barely begun. providing access to information on health and new health products and services including e-health is only a small part of the issues at stake as sakellarides points out in his chapter. there is in general a big democratic deficit in relation to health and health policy, which needs to be addressed with urgency: the reorientation toward participation and user involvement will be one of the most important governance shifts in health. what will innovation in health policy imply in the st century? if innovation means a reorganization of how we approach health in st century societies, i propose that the following five dynamic processes will be critical. our societies will need to • develop a new understanding of health as an investment and productive force in society • develop separate governance mechanisms for health and for health care, with a strong focus on accountability for health gain • augment the concern for ethics and values with respect to health through a broad dialogue with citizens in order to increase democratic legitimacy and ensure solidarity • move beyond a narrow understanding of health outcomes in terms of only physical health measures to those that aim to include or even prioritize broader measures of wellbeing • engage in network governance, partnership and multi-stakeholder approaches in rder to achieve health goals. the big st century health challenges call for more courageous and democratic policy approaches than applied so far. while our societies have now learned to recognize the urgency of the environmental challenge in terms of long-term sustainability, we are only just beginning to grasp the consequences that our way of life has in terms of health sustainability. an example of developing such a change in mindset are the health in all policy principles developed in the south australian government in through a health in all polices process [ ]. a "health in all policies" approach reflects health as a shared goal of all of government. in particular, it . recognizes the value of health for the well-being of all citizens and for the overall social and economic development of south australia. health is a human right, a vital resource for everyday life and a key factor of sustainability. . recognizes that health is an outcome of a wide range of factors -such as changes to the natural and built environments or to social and work environments -many of which lie outside the activities of the health sector and require a shared responsibility and an integrated and sustained policy response across government. . acknowledges that all government policies can have positive or negative impacts on the determinants of health and such impacts are reflected both in the health status of the south australian population today and in the health prospects of future generations. . recognizes that the impacts of health determinants are not equally distributed among population groups in south australia and aims at closing the health gap, in particular for the aboriginal peoples. . recognizes that health is central to achieving the objectives of the south australian strategic plan -it requires both the identification of potential health impacts and the recognition that good health can contribute to achieving south australia strategic plan targets. . acknowledges that efforts to improve the health of all south australians will require sustainable mechanisms that support government agencies working collaboratively to develop integrated solutions to current and future policy challenges. . acknowledges that many of the most pressing health problems of population health require long-term policy and budgetary commitment as well as innovative budgetary approaches. . recognizes that indicators of success will be equally long term and that regular monitoring and intermediate measures of progress will need to be established and reported back to south australian citizens. . recognizes the need to regularly consult with citizens to link policy changes with wider social and cultural changes around health and wellbeing. . recognizes the potential of partnerships for policy implementation between government at all levels, science and academia, business, professional organizations, and nongovernmental organisations to bring about sustained change. an additional complexity is due to the fact that health in the st century is inherently global and many determinants of health are no longer in the control of nation states. global and regional agreements of an economic and political nature can seriously endanger health -as experienced in rising alcohol rates in finland and sweden when they joined the european union -or they can move the health agenda forward through transnational and global health agreements. the last years have seen the acceptance by the who member states of both the international health regulations and the framework convention on tobacco control. but other less binding approaches, such as the forceful move on a global strategy to combat chronic diseases, the policy by the european union to consider the health impacts of all policies of the eu, the discussions on health at the davos world economic forum, the new priority assigned to health in the oecd, and the product shift of many global companies, all illustrate the global driving force that health has become. concerns arise around the global pharmaceutical market as much as over the global spread of sugary soft drinks, the global movement of health professionals as much as over the rapid global spread of viruses [ ] . while the policy innovations for health required at the global level are not subject of this book, the authors are aware that this global nature of health is in itself one of the most significant driving forces of the reorganization of health in the st century. magazine daily summary. oecd forum innovation, growth and equity, paris france - exploring technological innovations in health systems. conference board of canada oecd health and innovation survey the consequences of modernity liquid life health and modernity leading for innovation: & organizing for results social determinants of health health and consumer protection directorate ( ) the contribution of health to the economy of the european union tackling obesity -future choices project report sweden's new health policy. stockholm . public health agency of canada: determinants of health world health organization (who) ( ) constitution settings' based health promotion: a review territorial innovation models: a critical survey canadian index of wellbeing the nordic region as a global health lab theorie der wirtschaftlichen entwicklungen ( . auflage, ursprünglich ) wandel im gesundheitsmarkt: strategische ausrichtung der pharma-und biotechindustrie auf künftige marktbedingungen und träventive therapien. dissertation, eth zürich ) lissabon strategie. ec.europa.eu/ growthandjobs/index de die gesundheitsgesellschaft securing good health for the whole population. hm treasury. www.hm-treasury.gov.uk/consultations and legislation/wanless/consult wanless final.cfm open innovation health targets in europe adelaide revisited: from healthy public policy to health in all policies health strategy white paper fighting cardio-vascular diseases by prevention and early diagnosis eu platform on action on diet, physical activity and health. ec.europa.eu/health/ph determinants/life style/nutrition/platform/platform en.htm . hippel e. von ( ) democratizing innovation the european patient of the future. picker institute europe sustainable innovation as a corporate strategy consumer power house health consumer powerhouse: euro health consumer index ( ) www.healthpowerhouse.com/media/rapport ehci die ambulante versorgung aus sicht von bevölkerung undÄrzteschaft health literacy. towards an active health citizenhip risk and socio cultural theory, new directions and perspectives. cambridge special theme: health and foreign policy some parts of this chapter are based on a working paper for the academic advisory group, which provided the guidance for the work on this publication. it was published as an editorial. ( key: cord- - nq yzvz authors: yang, fan; jiang, yao title: heterogeneous influences of social support on physical and mental health: evidence from china date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: nq yzvz employing a national representative survey (the china labor-force dynamics survey , clds ) data (n = ), this paper examines the heterogeneous influences of social support on individual physical and mental health in china. social support is characterized by four dimensions: emotional support, tangible or instrumental support, interaction or exchange support, and community support. physical health is measured by self-rated health and body mass index (bmi), while mental health is measured by depression, hopelessness, failure, fear, loneliness, and meaninglessness. the results indicate that different dimensions of social support have heterogeneous effects on individual physical and mental health. specifically, the correlation between emotional support and individual physical health is not significant, but emotional support is significantly related to some mental health variables. tangible or instrumental support is significantly related to individual self-rated physical health but not to bmi or mental health. interaction or exchange support is significantly correlated with individual self-rated health and some mental health variables. in general, there are significant correlations between community support, and individual physical and mental health. the results also suggest that the influences of social support on physical and mental health of individuals at different ages (< years and ≥ years) are heterogeneous. the results of this study provide direction for the dimension selection of social support to promote individual health. individuals are embedded within a society, and social support affects multitudinous aspects of individuals, including health. individual good health is a valuable aspect of life and social development, and the relationship between social support and individual health is receiving increased academic attention [ ] [ ] [ ] . while social support can affect both individual physical and mental health [ ] , it is unclear which is more closely related to social support. this paper investigates whether there is any heterogeneity in the effects of multidimensional social support on physical and mental health. further, the influences of multidimensional social support on health at various ages are investigated. answers to the above issues have not reached academic consensus, as evidenced by a literature review conducted in this study. social support refers to the care and support that social members can receive from others [ ] . it can improve individual social adaptability [ ] and is a potential social factor affecting individual health [ ] . as early as the s, the world health organization (who) presented a multidimensional definition of health, which was a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity [ ] . as can be seen from this definition, health is a multidimensional concept, including not only physical health but also mental health. from to , the burden of mental disorders globally was enormous, with an estimated . billion population affected by mental or substance use disorders [ ] . a growing body of literature has demonstrated that the amount and quality of social support from relatives, friends, neighbors, and the community are pivotal factors in positively affecting a person's physical and mental health [ ] [ ] [ ] and acts as a form of prevention against harmful behaviors and distressing emotions [ ] . social support is one of the well-documented factors influencing physical health outcomes [ , ] . the most compelling evidence on the physical health outcomes of social support is a meta-analysis of the existing literatures that found that social support significantly lowers the risk for mortality [ ] . studies have shown that, the stronger a person's social support network, the more likely they are to obtain more wealth, higher social status, as well as medical resources to prevent diseases and to maintain good physical health [ , ] . these individuals with strong social support networks can use these supports to receive good treatment when faced with disease [ ] . conversely, those who do not have much social support may not have enough resources to remain healthy. when they are suffering from disease, it is also challenging for them to obtain good medical resources or to pay for treatment, which causes their health to further deteriorate [ ] . previous studies have argued that social support is a factor affecting mental health, and these studies have shown that there are two primary ways that social support affects individual mental health [ , ] . the first is main (or additive) effects of social support on health [ ] . it is argued that social support has a generally beneficial effect. when the amount of social support increases, the level of individual mental health improves [ ] . the second is stress-buffering (also termed moderating or interactive) effects of social support on mental health [ ] . in this case, research suggests that social support only plays a role in mental health under stress. social support minimizes the impacts of stress from negative life events on psychological health [ ] . however, empirical studies do not reach a consensus on the two ways that social support affects individual mental health. some studies have found evidence of the main or stress-buffering effect of social support on health [ ] [ ] [ ] [ ] . for example, a study on the mental health of incarcerated offenders showed that perceived social support helps safeguard the mental health of offenders [ ] . further, a study of college students with disabilities showed that both the main and buffering effects of social support effectively relieve their financial pressure [ ] . conversely, other studies have shown that the effect of social support on mental health is not significant [ , ] . for example, a five-year longitudinal study has found that social support does not uniformly mitigate the effects of stressors on health for individuals living in urban poverty [ ] . in conclusion, previous researchers have mainly studied the correlations between social support and health from the two perspectives of physical and mental health [ , ] . these two perspectives should be compared, but the results of the presented works may be incomplete if analyzed from one perspective alone. social supports are multifaced [ , ] . previous studies mainly used functional and global functional concepts to measure it. functional social support refers to the functions performed for individuals by significant others or secondary group members. the most frequently noted functions are emotional, informational, and instrumental assistance [ ] . the measurement of global functional social support combines the functional social supports mentioned above into a single index [ ] . in this paper, under the consensus that total social support influences individual health, we do not intend to combine varying functional social supports into a single index. instead, we investigate the heterogeneous influences of various functional social supports on individual physical and mental health. based on previous studies, we divided social support into four dimensions: emotional support, tangible or instrumental support, interaction or exchange support, and community support [ , ] . emotional support plays a protective role in individual physical and mental health. for physical health, studies have demonstrated that individuals who lack emotional support are twice as likely to commit suicide and to suffer from myocardial death and cardiac disease compared to individuals who have emotional support [ , ] . for mental health, emotional support is associated with a reduction in psychological distress and anxiety [ , ] . tangible or instrumental support refers to giving individuals practical support, such as financial assistance [ ] . effective tangible or instrumental support can help individuals maintain their general health or recover from illness [ ] . from the perspective of psychology, productive interaction or exchange support involves having people who can discuss important personal issues. not only does this release individual anxiety and pressure but also this kind of support enables collaborative solutions to be reached. [ ] . in china, with the improvement of rural and urban community management, the grassroots community plays an increasingly vital role in people's lives, which includes their health [ ] . members of a community often form an intimate group. through mutual acquaintance, trust-building, and mutual assistance, they can become a source of social support for each other [ ] . in terms of specific measurement indicators, the number of friends a person has is used to measure emotional support [ ] . tangible or instrumental support is commonly measured by the number of people that an individual can borrow money from [ , ] . interaction or exchange support is usually measured by the number of people who can discuss important personal issues together [ ] . community members' familiarity, trust, and mutual assistance is used to measure the level of community support [ ] . in addition to social support, individual health is also affected by other factors. gender, age, religion, marital status, health habits, and socioeconomic status are individual characteristics that are intimately related to health [ ] . gender is a widely documented determinant of health. studies have indicated that feminine and undifferentiated gender roles are related to poor self-rated health and that the average health status of men is better than that of women [ ] . it is recognized that individual health declines with age [ , ] . regarding an individual's marital status, single people experience higher mortality and poorer health than married people [ ] . studies on the link between religion and mental health have consistently revealed that spiritual people turn to their religious beliefs as one of the first resources when faced with traumatic life events or significant stressors [ , ] . multiple studies of the factors influencing individual health have found compelling evidence concerning damaging health habits and behaviors such as smoking, drinking, and beneficial habits like regular physical activity [ ] . an individual's socioeconomic position involves the indicators of income, occupational prestige, and attaining education, which are intimately linked to health care accessibility and health literacy [ , ] . studies have consistently documented that individuals with high incomes and good education are healthier than poorer, less educated people [ ] [ ] [ ] . apart from individual characteristics, the environment in which the person is located also influences individual health. a growing, global body of literature has focused on the negative impacts of environmental pollution, especially air pollution, on individual health [ ] [ ] [ ] [ ] [ ] [ ] . studying the health of chinese people has great social significance for both the general public and for the chinese government. first, according to data released by the chinese government, about % of the poverty experienced by china's rural population is caused by health problems [ ] . this means that, with increased social support, improving people's health can play a role in alleviating poverty. second, there was a large seasonal and internal migrant population in china, consisting of around million people at the end of [ ] . they migrated from rural areas where their household was registered to urban places to seek work. in this process, whether social support is available may affect individual income as well as health. additionally, the first blue book of chinese mental health ( - ), released by the chinese academy of sciences institute of psychology, shows that an increasing number of individuals experience psychological problems in china [ ] . the chinese government is committed to building a healthy population in china. citizens' health is a symbol of national prosperity. the government is gradually improving national health policies to provide people with comprehensive health services. improving individual social support is part of these policies. in conclusion, it is of great pragmatic significance to study the effect of social support on the health of chinese people. this paper aims to fill some of the gaps in current studies on individual health. based on big data from china, this study adopts quantitative research methods to analyze the heterogenous affecting of social support on individual physical and mental health. first, this study attempts to give a description of the influence of multidimensional social support on both individual physical and mental health. second, this study shows a comparison of each dimension of social support on individual physical and mental health, which strongly proves the varied effects of social support on health. finally, this study expands the heterogeneity to age and effectively identifies the heterogeneous influence of each dimension of social support on different ages' mental health. the data of this paper comes from the china labor-force dynamics survey (clds ) carried out by sun yat-sen university in . the survey covers education, work, migration, health, economic activities, and other interdisciplinary aspects. in this survey, a multi-stage, multi-level probability sampling method proportional to the size of the labor force is adopted. to ensure national representation, the samples cover provincial administrative units (hong kong, macao, taiwan, tibet, and hainan are not included). therefore, this dataset is highly representative of china. it is a public dataset that all researchers can use by applying to sun yat-sen university. the survey is conducted by computer assisted personal interviewing (capi) technology. in order to reduce the estimation bias as much as possible, this paper removes invalid samples in the original data table. specifically, the samples with the following characteristics have been deleted: refusing to answer key questions or answering "inapplicable, unclear" and obvious logical contradictions. finally, , valid samples were used in this paper. therefore, the data this paper employed can be regarded as big data in terms of both the national representation of the survey scope and the absolute number. two dimensions, physical health and mental health, of respondents were measured. for the first dimension, physical health, survey participants were asked, "how do you evaluate your current health (variable named self-rated health)?" the answer was measured using a five-point likert scale ranging from " " to " ". an answer of "very bad" was coded as " ", "bad" was coded as " ", "normal" was coded as " ", "good" was coded as " ", and "very good" was coded as " ". considering the subjectivity of self-rated health, this paper also used body mass index (bmi) to measure the physical health of respondents. in the standards provided by the world health organization (who), . ≤ bmi < refers to a normal weight range [ ] . however, according to a study published in the lancet by who experts, a normal bmi between . - may be more appropriate for asians [ ] . therefore, we chose the range of bmi from . to as normal weight. if . ≤ bmi < , it was coded as " "; otherwise, it was coded as " ". individuals who develop mental health problems may experience feelings of depression, hopelessness, failure, fear, loneliness, and meaninglessness [ ] . therefore, for the second dimension, mental health, respondents were asked six questions: "how often do you feel depressed (variable named depression)?", "how often do you feel like there is no hope (variable named hopelessness)?", "how often do you feel you have failed (variable named failure)?", "how often do you experience fear (variable named fear)?", "how often do you feel lonely (variable named loneliness)?", and "how often do you feel life is meaningless (variable named meaninglessness)?" the answers were coded from " " (very low frequency) to " " (very high frequency), which meant that the individual mental health status was ranked from good to poor [ , ] . explanatory variables in social support include four dimensions: emotional support, tangible or instrumental support, interaction or exchange of support, and community support. for the first dimension, emotional support, respondents were asked two questions: "how many friends do you have locally (variable named friends)?" and "how many people can you speak your mind to (variable named speaking one's mind)?" the answers to both questions were numerical. in other words, emotional support was defined by two variables: friends and speaking one's mind. for the second dimension, tangible or instrumental support, respondents were asked, "how many people can you borrow money from (variable named borrowing money)?" the answer to the question was also numerical. it meant that tangible or instrumental support was defined by the variable of borrowing money. for the third dimension, interaction or exchange of support, respondents were asked, "how many people can you discuss important personal issues with (variable named discussion)?" the answer was still numerical. in other words, interaction or exchange of support was defined by the variable of discussion. for the fourth dimension, community support, respondents were asked three questions: "how familiar are you with the members in your community (variable named familiarity)?" the answer was measured by a five-point likert scale ranging from " " (very unfamiliar) to " " (very familiar). "to what extent do you trust the members in your community (variable named trust)?" the answer was also measured using a five-point likert scale ranging from " " (very distrustful) to " " (very trustful). the final question of the fourth dimension was "do you have mutual aid with the members in your community (variable named mutual aid)?" the answer was again measured by a five-point likert scale ranging from " " (very little) to " " (very much). it meant that community support was defined by three variables: familiarity, trust, and mutual aid. according to the analysis in the introduction section, the control variables of this paper included gender, age, education, marital status, religion, income, working time, smoking, drinking, exercise, and region. gender was a dummy variable. male was coded as " ", and female as " ". age was a continuous variable. education referred to the number of years of schooling, which was also a continuous variable. marital status was a dummy variable, which was divided into "single", "married", "divorced", and "widowed". religion was a dummy variable, which was clustered into "western religion (including catholicism, christianity, and the eastern orthodox church)", "eastern religion (including southern buddhism, tibetan buddhism, taoism, islam, and folk religions)", and "no religion". income was a continuous variable, which referred to the total income of respondents in , mainly composed of wage income, operating income, property income, and transfer income. in regression analysis, we took the logarithm of income. working time was measured by the average number of days respondents worked in one month ranging from " " to " ". smoking and drinking both were dummy variables with " " representing "yes" for each of the two variables. exercise was measured by asking the question, "do you exercise regularly in your daily life?", with " " representing "yes". region was a dummy variable and was measured by the provinces where respondents were located. the eight measures of outcome, ( ) self-rated health, ( ) bmi, ( ) depression, ( ) hopelessness, ( ) failure, ( ) fear, ( ) loneliness, and ( ) meaninglessness, were used as the dependent variables. the ordered probit (oprobit) regression models were used to estimate the results of ( ) self-rated health, ( ) depression, ( ) hopelessness, ( ) failure, ( ) fear, ( ) loneliness, and ( ) meaninglessness, due to these dependent variables being ordered discrete data. the logistic regression model was used to estimate the result of ( ) bmi, due to the bmi being measured as binary. the statistical software stata version . mp was used to implement the analysis (statacorp. lp., college station, tx, usa). there are two main limitations of this paper. one is in research and design. our data is second-hand data collected by other research institutions. health and social support are only part of this dataset. in addition, mental health is a complex concept, so it is extremely difficult to quantify accurately. therefore, we only use six indicators to measure mental health, which is obviously not enough to represent its complexities. future research can cautiously expand the dimensions of mental health. the second limitation of this paper is in the methods used. this is also related to the data. due to the cross-sectional nature of the data, this paper does not explore the internal mechanisms of social support for physical and mental health. future research can continue to expand on this point. in terms of physical health, the average value of self-rated health is . (sd = . ). bmi shows that . % of the respondents' weights were within the normal range. in terms of mental health, the mean values of six indicators are all less than , among which, the mean value of depression is when reviewing social support factors that may influence physical and mental health, on average, respondents had . friends, . respondents had people with whom they could speak their mind, . people from whom they could borrow money, and . people with whom they could discuss important personal issues. in terms of community support, the average degree of familiarity of the respondents and other members of the community is . , the average degree of trust of the respondents and the other members of the community is . , and the average value of mutual aid between the respondents and the other members of the community is . . the influences of the social support factors on the two physical health dimensions, self-rated health and bmi, are estimated separately by an oprobit regression model and a logistic regression model. the results are shown in table . the number of samples used in the estimations is , . varied technical diagnostic tests were conducted [ , ] , and the results show that the two models are good fits. it can be observed from table that the influences of social support on self-rated health and bmi are heterogeneous. specifically, the two indicators of emotional support (friends and speaking one's mind) do not significantly affect self-rated health and bmi. tangible or instrumental support (borrowing money) significantly and positively affects self-rated health but not bmi. this result means that, with the increase of tangible or instrumental support (borrowing money), individual self-rated health level is correspondingly higher on average. similarly, interaction or exchange support (discussion) affects self-rated health significantly and positively but not bmi. on average, individuals with more people to discuss important personal issues with have higher self-rated health. in terms of community support, the respondents' degree of familiarity with other members of the community has a significant and positive effect on the self-rated health of the respondents and has a significant and negative effect on bmi. the degree of trust that the respondents have with the other members in their community has a significant positive effect on both self-rated health and bmi. the frequency of mutual aid behavior of the respondents and community members significantly and positively affects the self-rated health of the respondents but not their bmi. for the results of the control variables, on average, the older the respondent is, the lower their self-rated health level is. similarly, the older the respondent is, the lower the probability that their weight is within the normal range. for education, the more years of schooling the respondent has, the higher their self-rated health level is. in terms of income, the self-rated health level of the respondent increases with the increment of annual income. finally, people who adhere to regular exercise have higher self-rated health levels compared with those who do not exercise regularly. oprobit regression models are used to estimate the influences of social support factors on the six mental health dimensions in this study (depression, hopelessness, failure, fear, loneliness, and meaninglessness). the results are shown in table . the number of samples used in the estimations is also , , and the models are found to be a good fit [ ] . notes: standard errors in parentheses; *** p < . , ** p < . , * p < . . table shows that the more friends the respondents have, the higher frequency they feel depression, failure, and fear; the more people the respondent has to discuss important personal issues with, the less likely respondents will experience feelings of hopelessness, failure, and loneliness; and the more familiar the respondents are with members of their community, the better their mental health is, that is, the less likely the respondents will feel depressed, hopeless, afraid of failure, fearful, lonely, and meaningless. similar results appeared as the respondents were more trusted within their community. the more mutual aid behaviors the respondents have with other members of their community, the better their mental health is, and respondents thus experience less frequent feelings of hopelessness, failure, loneliness, and meaninglessness. in the control variables, on average, compared with women, men's mental health is better. they spend less time feeling depressed, hopeless, like a failure, fearful, lonely, and meaningless than women do. the amount of time that respondents feel these variables increases with age. the higher the level of education of the respondents, the lower the frequency of depression, hopelessness, failure, fear, loneliness, and meaninglessness they feel. regarding marital status, compared with single people, married respondents have better mental health. they spend less time feeling the above variables than single people do. the more income the respondents earn, the less likely they are to feel depressed, hopeless, failed, feared, lonely, and meaningless. respondents who exercise regularly are also less likely to feel these variables. age is significantly associated with mental health [ ] . as such, we grouped the samples into two subgroups-respondents below and those and over-to check the heterogeneous influence of emotional, tangible or instrumental, interaction or exchange, and community support on individual mental health at different ages. the results are reported in table . it can be observed from table that not all the variables (friends and speaking one's mind) related to emotional support have significant effects on individual mental health across the two different age subgroups. specifically, the number of friends that respondents have has significant negative effects on the mental health variables of depression, failure, and fear in the below- subgroup. the variable of speaking one's mind shows a significant positive effect on easing the feeling of failure in the -and-over subgroup, while it has no significant effects on the other mental health variables. for tangible or instrumental support, the variable of borrowing money only has a significant positive effect of relieving feelings of depression, hopelessness, and loneliness in the -and-over subgroup. the variable did not affect the mental health of those aged below . in terms of interaction or exchange support, the coefficients of variables of discussion are insignificant across the two subgroups, demonstrating that the interaction or exchange of support does not affect respondents' mental health status positively or negatively. overall, community support is the most crucial dimension of social support affecting individual mental health. the degree of familiarity respondents share with the other members of their community has significant, positive influences on every assessed mental health status in the below- subgroup. in contrast, in the -and-over subgroup, the degree of familiarity lessens the feelings of depression and fear significantly. the degree of trust that the respondents share with the other community members improves overall mental health across the two different subgroups significantly. alternatively, the trust between community members shows that there is a strong association of mental health with community support among individuals. the mutual aid behaviors of the respondents and other community members is significantly and positively correlated with alleviating feelings of hopelessness, failure, and meaninglessness but significantly exacerbates the feeling of fear in the -and-over subgroup. for the below- subgroup, the effects of mutual aid are significantly positive and help alleviate loneliness and meaninglessness. notes: standard errors in parentheses; *** p < . , ** p < . , * p < . . by analyzing updated and representative survey big data from china, this paper examines the influence of social support on individual health. different from previous studies, we examine the influences of social support on individual physical and mental health and attempt to find heterogeneity between them. we find that the number of friends that respondents have has no significant influence on their own physical health (self-rated health and bmi). however, the number of friends has a significant influence on some aspects of respondents' mental health (depression, failure, and fear). we questioned why people with more friends feel more depressed, failed, and fearful. we speculate that this is related to the comparative effect. to a large extent, the psychological problems of individuals come from people close to them, such as family members and friends, rather than strangers [ , ] . the more friends a person has, the more people the person can compare themselves with. generally, the more friends a person has, the greater the probability of having more highly accomplished friends. comparing oneself with those talented friends may induce depression, a sense of failure, and fear. this is not the fault of the friends but instead how people think about the role of friends in their lives. the number of people that the respondents could borrow money from significantly affects the respondents' self-rated health but does not significantly affect bmi and mental health. based on these results, we can argue that the influence of tangible or instrumental support on individual health, especially mental health, is limited. therefore, these results above provide evidence for future studies to reconsider the heterogeneous effects of different dimensions of social support on individual health. additionally, there is the potential for future studies to consider whether tangible or intangible support has the most significant effect on individual health. having more people with whom the respondent can discuss important personal issues not only can improve the self-rated health of respondents but also can make them feel less hopeless, failed, and lonely. the importance of discussion is reflected in that it can reduce the cognitive limitations of an individual, can open one's mind, can find solutions to problems, and can create a sense of hope. helping individuals find others to discuss things with will be a potential way that government and nongovernmental organizations (ngos) can provide social support for individuals. specifically, the government and ngos can set up community-based advice agencies to provide constructive suggestions on the problems that individuals encounter in daily life to increase their social support. the more familiarity the respondents have with other community members, the higher their self-rated health level is but the greater the probability that their bmi is within an abnormal range. although it is difficult to give a reasonable explanation for the above results, it shows that different choices of health indicators may produce different results. whether to choose subjective or objective indicators to measure physical health is worthy of further study. however, the influence of this variable (familiarity) on the mental health of respondents is consistent. it has a significant positive effect on the six variables (depression, hopelessness, failure, fear, loneliness, and meaninglessness) of mental health. the more familiar the respondents are with other community members, the better their mental health is and the less depressed, hopeless, failed, fearful, lonely, and meaningless they feel. this is evidence that community support has a significant effect on individual mental health, consistent with previous studies [ ] . this result suggests that community involvement should be emphasized when strengthening social support. specific measures may include holding communal activities for promoting fellowship, so that community residents can be well acquainted with each other. there is a significant correlation between the degree of trust of respondents with the other community members and the respondents' mental health. the more trust the respondents have with other community members, the better their mental health is. trust is the foundation of mental health [ , ] . against the social background of the trust crisis in china [ ] , this result reminds us again that we cannot ignore the role of trust in people's mental health. positive measures should be taken to maintain interpersonal trust, which is not only beneficial to the mental health of social members but also beneficial to the healthy development of the whole society. mutual aid behavior has a significant correlation with hopelessness, failure, loneliness, and meaninglessness. the more the members of a community help each other, the less time members experience hopelessness, a sense of failure, loneliness, and meaninglessness. however, the frequency of mutual aid behavior within a community significantly affects the self-rated health of respondents but not bmi. the results remind us again that, in the process of measuring health, choosing different indicators may produce different results. additionally, the above results suggest that mutual aid behavior is beneficial to people's mental health. therefore, it is necessary for the community to establish a set of effective mechanisms to stimulate community members to help each other. to conclude, community support plays a prominent role in the four dimensions of social support. our study shows that age plays a moderating role in the impact of social support on mental health. people under the age of and people aged and above have heterogeneous perceptions about the effects of various social support dimensions on different mental health indicators. therefore, the social support measures provided to these two age groups to help them improve their health must also be heterogeneous and targeted. specifically, according to the results of this paper, community support is needed by both age groups (< and ≥ ), tangible or instrumental support is needed more by the age group over (including ) , and more emotional support should be given to the age group below . for the control variables, the results are mostly consistent with previous studies. in particular, we find that the influence of gender on mental health is heterogeneous. on average, compared with women, men's mental health is better. in addition to the psychological and physiological differences of gender, it may also be related to the different social division of labor between men and women in china. although the status of women has been greatly improved in china, generally, most women are still in a subordinate position in a family. household chores are dealt with mainly by women, which can easily lead to mental health issues [ ] . therefore, women's mental health problems deserve further attention. reasonable family division of labor may help to alleviate this problem. in addition, we find that marriage is a way to alleviate mental health problems. compared with single people, those who are married enjoy better mental health. they spend less time feeling depressed, hopeless, like a failure, fearful, lonely, and meaninglessness than single people. good interaction and communication between a husband and wife are beneficial to one's mental health [ ] . in conclusion, this paper has shown that different social support dimensions have heterogeneous effects on individual physical and mental health. specifically, tangible or instrumental support (borrowing money), interaction or exchange support (discussion), and community support (familiarity, trust, and mutual aid) are significantly correlated with individual self-rated health. community support (familiarity and trust) is significantly correlated with individual bmi. compared with the other three dimensions, community support plays the most important role in individual mental health. this paper finds that friends do not play a positive role in the depression, failure, and fear dimensions of individual mental health. the results also suggest that the effects of social support on the physical and mental health of individuals at different ages (< years and ≥ years) are heterogeneous. in addition, this study reminds us that different health measurement methods may produce different results. therefore, scientific measurement of health is the key to achieving more accurate results on this topic in future research. this paper has contributed to the literature on the heterogeneous influence of social support on individual physical and mental health in china. author contributions: f.y. proposed the idea of this paper and wrote most of the text including the literature review, methods, results, discussion, and conclusions. y.j. performed the theoretical and data analysis and edited the paper. all authors have read and agreed to the 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satisfaction, and mental health according to age and (un)employment status mental health of family, friends, and co-workers of covid- patients in japan a comparative study of online depression communities in china community factors supporting child mental health assertiveness and organizational trust as predictors of mental and physical health in a romanian oil company epa guidance on building trust in mental health services trust collapse caused by the changsheng vaccine crisis in china urban/rural and gender differentials in suicide rates: east and west does marriage have positive effects on the psychological well-being of the individual? key: cord- - z ykb authors: healing, tim title: surveillance and control of communicable disease in conflicts and disasters date: journal: conflict and catastrophe medicine doi: . / - - - - _ sha: doc_id: cord_uid: z ykb nan tim healing • to describe the principles of health surveillance in conflict and disaster situations • to assist in organizing a health surveillance system in conflict and disaster situations • to describe the principles of control of communicable diseases in conflict and disaster situations • to assist in organizing a response to outbreaks and epidemics • to introduce the challenges associated with health surveillance and communicable diseases in conflict and disaster situations there are five fundamental principles for the control of communicable disease in emergencies: • rapid assessment -identify and quantify the main disease threats to the population and determine the population's health status • prevention -provision of basic health care, shelter, food, water, and sanitation • surveillance -monitor disease trends and detect outbreaks • outbreak control -control outbreaks of disease. involves proper preparedness and rapid response (confirmation, investigation, implementation of controls) • disease management -prompt diagnosis and effective treatment rapid assessment has been dealt with elsewhere in this book as have the prevention aspects of disease control (adequate shelter, clean water, sanitation, and food, together with basic individual health care). this chapter therefore covers surveillance, outbreak/epidemic control, and public health aspects of disease management. the topics are dealt with in general terms. more details can be found in references. disasters, particularly conflicts, by damaging or destroying the infrastructures of societies (health, sanitation, food supply) and by causing displacement of populations, generally lead to increased rates of disease. outbreaks and epidemics are not inevitable in these situations and are relatively rare after rapid-onset natural disasters, but there is a severe increase in the risk of epidemics during and after complex emergencies involving conflict, large-scale population displacement with many persons in camps and food shortages. in most wars more people die from illness than from trauma. preventing such problems, or at least limiting their effects, falls on those responsible for the health care of the population affected by the emergency. they must be able to • assess the health status of the population affected and identify the main health priorities • monitor the development and determine the severity of any health emergency that develops (including monitoring the incidence of and case fatality rates from diseases, receiving early warning of epidemics and monitoring responses) at first sight, undertaking public health activities in emergencies, especially in conflicts, may seem to be difficult or impossible. the destructive nature of warfare may prevent or inhibit the provision of adequate food and shelter, of clean water and sanitation and vaccination programs. despite the difficulties that warfare imposes, it is generally possible to undertake at least limited public health programs, including disease surveillance and control activities. in other types of disaster public health activities may be expected to be less affected by the security situation than in a war (although aid workers may be at risk if populations are severely deprived of resources such as food, shelter, water, or cash), and with limited access and damage to communication systems and other parts of the infrastructure assessment, surveillance and control activities can be severely restricted. for example, following the pakistan earthquake late in access was severely restricted for some time and the urgent need to treat the injured and provide food and shelter meant that the limited transport available was heavily committed. the surveillance and control of communicable disease require data which can be collected in one of three ways: . surveillance systems -covering all or at least a significant proportion of the population . surveys -in which data are collected from a small sample of the affected population considered to be representative of the whole . outbreak investigations -in-depth investigations designed to identify the cause of deaths or diseases and identify control measures although the latter two can provide valuable information for disease control and form part of the surveillance process, proper control of disease requires regular monitoring of the overall disease situation, which in turn requires the establishment of a properly designed health surveillance system. it is important therefore that responsibility for surveillance activities is defined at the beginning of planning for an aid mission. generally speaking, a team will be required, including a team leader (often an aid agency health coordinator), who should ideally have surveillance experience, clinical workers, a water and sanitation specialist, and representatives of the local health services and communities. the team may also need clerical, logistic, information technology and communications specialists. the world health organization defines health surveillance as "the ongoing systematic collection, analysis and interpretation of data in order to plan, implement and evaluate public health interventions." data for surveillance must be accurate, timely, relevant, representative, and easily analyzed, and the results must be disseminated in a timely manner to all who need to receive them. in addition the data collected, the methods used for collection and the output must be acceptable to those surveyed (health-care professionals and the population). in emergencies the time that can be given to surveillance by medical personnel is likely to be limited and surveillance activities will be far from the minds of most of those involved. therefore the methods used need to be rapid, practical, and consistent, and while the greatest possible accuracy must be achieved, "the best must not be the enemy of the good." it is necessary to strike a balance between collecting large amounts of information ("what we would like to know") and collecting too little which can lead to an ineffective response. those responsible for establishing surveillance programs must therefore try to determine what is really needed ("what we need to know"). it is better to err on the side of too much than of too little. ideally any existing surveillance system should be used. there is no point in establishing a system if one already exists, unless the existing one is inadequate or inappropriate or has broken down irretrievably. surveillance systems for use in conflict and disaster situations should therefore adhere as far as possible to the criteria given in table . . notes on these criteria: complexity and inflexibility are incompatible with surveillance systems generally and particularly when operating in emergencies where collection of data may be difficult and where situations can change very fast. defining what you "need to know" will allow you to set up the appropriate data collection methods (questionnaires, sites, etc.) and to design the system so that it can obtain and handle the information required. information that is accurate but out of date is useless for immediate disease control purposes and of little value for forward planning. communications therefore form an integral part of any surveillance system. do not try to overreach when setting up a system. for example, expatriate staff may best be used to recruit local staff for the system and in supervisory activities rather than in collecting data. this criterion is certainly a goal to aim for as sustainability must be the target for all aid work. however, there may be situations where an emergency system is needed rapidly and where it cannot readily be integrated into existing systems or be developed as a new long-term system. . based on standardized sampling methods the sampling system must use the same data collection methods throughout if data are to be comparable. ideally this should be methods that are internationally agreed and approved. agreement should be sought for the methods from the other agencies on the ground to ensure consistency. without case definitions that are agreed by all parties the likelihood of success of a surveillance system is very low. this is especially so when laboratory support is minimal or absent since clinical case definitions have to be drawn very tightly if different diseases are not to be confused. routine surveillance requires more than material from ad hoc sources. sites such as medical centers (in towns, villages, or refugee camps), hospitals, and/or public health units should be recruited. the more comprehensive the coverage of the system, the more likely is it that the data will be accurate and complete and that problems will not be missed. such coverage can be problematic. the coverage of the different systems that can be used is discussed below. the data collected and the methods used should ideally fit in with systems that are operating or have previously operated in the area. following from criterion , if systems are already in existence or in abeyance but revivable then this should be done so as to ensure compliance by local health-care services and continuity of data collection and analysis. existing records are of considerable value for predictive purposes. knowledge of past problems makes it possible to anticipate future trends and problems and allows for early planning decisions. if several health agencies are operating it is essential to ensure collaboration among them in surveillance activities to avoid confusion and duplication of effort. . involve collaboration with local services so as to avoid duplication as above, early involvement of local health and surveillance services will reduce workloads and avoid duplication of effort. if those from whom the data are collected, those who are collecting the data, and those who will receive the results are unhappy with the system, the system is unlikely to operate effectively. these criteria can be used to evaluate a plan for a surveillance system and also, with some additions, to evaluate an existing system. however, failure to fulfil all these criteria need not rule out a system. in many emergencies it can be difficult to meet such a wide range of "best case" criteria, and the question that must be asked is whether the proposed system is capable of fulfilling its purposecan it provide sufficiently accurate essential information to those who need it when they need it? the emphasis of an emergency surveillance program may need to be altered as the situation changes especially if a particular item emerges as being of key importance. those running the surveillance program should use the data gathered and a continuous assessment of the general running of the system, to alter the program as required (preferably after consultation with relevant stakeholders). when designing health surveillance systems, it is essential to do the following: the population under surveillance may be relatively small and well defined (such as the population of a refugee camp) or a much less defined group such as mobile groups of refugees or idps or the population of a village, town, or region, the size of whose population may be unknown or may be fluctuating because of a disaster. establishment of denominators may therefore be difficult. even refugees or idp camps may present a challenge as, while the size of the population may appear to be (or actually be) stable, its makeup may vary over time because of movements in and out. if the age or sex makeup of the camp alters, the pattern of disease may also alter. both the number of cases detected and the rate of factors such as morbidity or mortality per unit of population are important values needed to inform emergency programs. those responsible for all aspects of health care need to know what numbers of cases are involved so as to ensure adequate provision of services (amounts of medicines, numbers of hospital beds, etc.). however, simple numbers are of little value in assessing trends and patterns since increases or decreases in numbers of cases (or numbers of deaths) may reflect changes in population size (resulting, for example, from population displacement) rather than a trend due to (for example) a particular disease. in addition, several rates (such as the crude mortality rate) are key indicators in defining health emergencies (see below). knowing the demography of the affected population is therefore important and all agencies working in an emergency should agree on and use the same population figures. the essential demographic data needed include the following: • total population size • population structure -overall sex ratio and the sex ratio in defined age groups -population under years old, with age breakdown ( - years) -this group has special needs and is usually a key factor in planning the emergency response -age pyramid -ethnic composition and place of origin -number of vulnerable persons (e.g., pregnant and lactating women, members of female-headed households, unaccompanied children, destitute elderly, disabled and wounded persons) at the outset it is therefore important to establish methods to obtain demographic data. often the best that can be managed initially is a rough estimate, but this can usually be refined later. it is helpful to use several methods and cross-check the figures to obtain the best estimate. surrogates of the whole population (such as those attending a clinic) may be the best that can be achieved early on. the ease with which such data can be obtained usually depends on the size and scale of the population under consideration. the demography of a well-run refugee camp is quite easy to obtain but that of a larger area may be much more difficult. a lack of knowledge of the size of a displaced group can be confounded by a lack of knowledge of the size of the resident population. in many countries with poor infrastructures, accurate census data are not available. in some instances tax records may be helpful if these can be obtained. it should be noted that demographic data, especially if they involve refugees and idps, can be politically sensitive and interested parties may place undue weight on any figures that are given. ideally, communicable disease surveillance should be nationwide (or at least "affected area wide"), drawing information from a range of health-care centers that cover a sufficient proportion of the population to ensure that the great majority of cases (preferably all) of the relevant conditions are reported. a surveillance system in a refugee or idp camp is effectively a miniature comprehensive system as it is possible to cover the whole population. there are situations where comprehensive surveillance is not possible and these often arise in disasters. damaged access and communications and staff shortages frequently mean that only limited numbers of reporting sites (sentinel sites) can be used. as far as possible these should be chosen to ensure a wide coverage of the area and also to maximize the proportion of the population that is covered. sentinel surveillance systems are inherently less satisfactory than comprehensive systems largely because they provide a much less complete coverage. the calculation of rates can sometimes be difficult or impossible; such systems can be very labour intensive, and important events may be missed. both types of system may rely on notification of cases based solely on clinical evidence (and this is the most likely situation in conflicts and disasters at least in the early stages), or may include laboratory verification of some or (preferably) all diagnoses. if there is more than one center involved in establishing the diagnosis (for example, a clinical department, a hospital laboratory, and a reference laboratory) the channels of reporting must be very carefully set up so as to avoid duplicate reporting. surveillance must provide information on key health indicators, which should include the following: the selection of information sought in these categories must be done carefully. it is neither possible nor desirable to monitor everything, especially in the early stages of a disaster response. at that stage (the acute phase) the priority of surveillance is the detection of factors that can have the greatest and most rapid effect on the population. in terms of communicable disease this means diseases that affect large numbers of people and have epidemic potential. in most instances this also means diseases for which effective rapid control measures exist. while gathering data on other largescale disease problems should not be excluded, the main surveillance and control efforts should be aimed where they can do the most immediate good. in the very early stages, only clinical information may be available since laboratory diagnostic services will probably be damaged or simply unavailable. however, this need not be a problem if the medical response is also geared to a syndromic approach. as the situation stabilizes, laboratory support becomes available, and longer term control measures can be supported, the surveillance can become more refined and additional diseases (for example, those which can cause severe morbidity and mortality in the longer term -such as tuberculosis, hiv or aids, and stds) can be added to the list. the main morbidity figures that are routinely sought are as follows: • incidence -the number of new cases of a particular disease reported over a defined period • attack rate (used in outbreaks -usually expressed as percentage) (also called incidence proportion or cumulative incidence) -number of new cases within a specified time period/size of the population initially at risk (× ). (e.g., if per , persons develop a condition over weeks, the ar/ip/ci is / , [ . %]) • incidence rate -number of new cases per unit of person-time at risk. in the above example, the ir is / , person-weeks. (this statistic is useful where the amount of observation time differs between people, or when the population at risk varies with time) • prevalence -the total number of cases of a particular disease recorded in a population at a given time (also called "point prevalence") (nb: prevalence "rate" is the number of cases of a disease at a particular time/population at risk) there are a number of ways of estimating morbidity. health information systems based on health center attendance are the most common but are passive and rely on who presents to the services. other ways of gathering morbidity data include the following: • surveys -in which data are collected from a small sample of the emergencyaffected population deemed to be representative of the whole (or from a particular group for a specific purpose) • outbreak investigations -which entail in-depth investigations designed to identify the cause of deaths or diseases and identify control measures as with disease, changes in numbers of deaths may reflect changes in population size. determination of rates is needed because mortality rate is an important surveillance indicator in an emergency. often the first indication that a problem is developing is an increase in death rate, especially in particular vulnerable groups. all deaths occurring in the community must therefore be recorded. the following indicators can provide the essential information to define the health situation in a population: • crude mortality rate (cmr) is the most important indicator as it indicates the severity of the problem, and changes in cmr show how a medical emergency is developing. cmr is usually expressed as number of deaths per , persons per day. if the cmr rises above / , per day (> / , per day for young children) an acute emergency is developing and the emergency phase lasts until the daily cmr falls to / , per day or below. • age-specific mortality rate (number of deaths in individuals of a specific age due to a specific cause/defined number of individuals of that age/day). in children this is usually given as the number of deaths in children younger and older than years/ , children of each age/day). nb: if population data for the under s are not available, an estimate of % of the total population may be used. • maternal mortality rate. maternal mortality is a sensitive indicator of the effectiveness of health-care systems. a maternal death is usually defined as the death of a woman while pregnant or within days of the termination of the pregnancy (for whatever cause) from any cause related to or aggravated by the pregnancy or its management. the -day cut-off is recommended by who but some authorities use a time of up to a year. maternal mortality rate = (number of deaths from puerperal causes in a specified area in a year/number of live births in the area during the same year) × , (or × , ) • cause-specific death rates (case fatality rates -usually given as a percentage). proportion of cases of a specified condition which are fatal within a specified time. case fatality rate = (no. of deaths from given disease in a given period/no. of diagnosed cases of that disease in the same period) × the following indicators must be measured: • prevalence of global acute malnutrition (includes moderate and severe malnutrition) in children - months of age (or - cm in height) (percentage of children with weight for height under two standard deviations below the median value in a reference population and/or edema) • prevalence of severe acute malnutrition in children - months of age (or - cm in height) (percentage of children with weight for height under three standard deviations below the median value in a reference population and/or edema) • • estimate number of children needing to be cared for in selective feeding programs • estimate number of additional calories per day provided by selective feeding programs immunization programs are a vital part of the public health measures undertaken following disasters. for example, measles vaccination is one of the most important health activities in such situations. the need for campaigns may be assessed on the basis of national vaccination records if they exist. in the absence of such records questioning of mothers may provide the information required, or children or their parents may have written vaccination histories with them (rare). the effectiveness of the programs undertaken can be assessed in defined populations by recording the percentage of children vaccinated. in less well defined populations an assessment of coverage may be made using the numbers of children attending clinics as a surrogate for the population as a whole. items such as water, sanitation, food, and shelter are essential to maintain a healthy population and prevent communicable diseases. depending on the circumstances it may be necessary to monitor these elements in the affected population. indicators such as number of consultations per day, number of vaccinations, number of admissions to hospitals, number of children in feeding programs are typically reported. other factors such as effectiveness of the supply chain, maintenance of the cold chain, and laboratory activities may also be surveyed. activities in related sectors such as water and sanitation, shelter and security may also be included. the major sources of health data will be hospitals and clinics (both national and those established by aid agencies), individual medical practitioners, and other health-care workers. specialized agencies should be able to provide data on particular needs (e.g., food, water, sanitation, and shelter). case definitions are an essential part of surveillance. if the diseases (or syndromes) that are to be covered by the system are not clearly defined, and if the definitions are not adhered to, the results become meaningless -changes from week to week are as likely to be due to changes of definition as to real changes in numbers of cases. this is especially important when laboratory confirmation is not possible. it is therefore important that all agencies working in an emergency agree to and use the same case definitions so that there is consistency in reporting. case definitions must be prepared for each health event or disease or syndrome. if available, the case definitions used by the host country's moh should be used to ensure continuity of data. several different sets of case definitions already exist, either in generalized form (for example, those produced by the centers for disease control in atlanta) or sets prepared for specific emergencies (e.g., the who communicable disease toolkit for the iraq crisis in ). standard case definitions may have to be adapted according to the local situation. it should be noted that such case definitions are designed for the purposes of surveillance, not for use in the management of patients, nor are they an indication of intention to treat the patients. when case definitions based purely on clinical observations are used, each case can only be reported as suspected, not confirmed (see table . ). although lacking precision, such definitions can make it possible to establish the occurrence of an outbreak. samples can subsequently be sent to a referral laboratory for confirmation. once samples have been examined and the causative organism has been identified, a more specific case definition can be developed to detect further cases. visits to surveillance sites and discussions with staff involved will help define the recording and data transmission systems required. the great advances in information technology that have been made in recent years have greatly facilitated the collection, recording, transmission, and analysis of surveillance data, but care must be taken that the systems put in place are appropriate. in areas where electricity supplies are problematical and communications poor it may be better to use a paper recording system and verbal data transmission by radio than a computerized system. data verification is essential for the credibility of a surveillance system. those responsible for surveillance systems must ensure good adherence to case definitions if a symptom-based system is in operation and that laboratory quality control systems operate where appropriate. regular assessments of record keeping and the accuracy of data transfer are required. triangulation of results from several sources can sometimes help to detect anomalies. frequency of reporting will usually depend on the severity of the health situation. in general, daily reporting during the acute phase of an emergency will be needed, although in an acute medical emergency (such as a severe cholera outbreak) even more frequent reporting may be necessary, especially if the situation is fluctuating rapidly. the frequency may reduce to (say) weekly as the situation resolves. who is to analyze the data and how it is to be analyzed must be established at the outset. in a relatively defined area such as a camp, a data analysis session may be the last of the daily activities of the person responsible for surveillance. if record keeping and analysis protocols have been carefully worked out initially this task is not necessarily a large additional burden. surveillance systems that cover larger areas and bigger and more diffuse populations usually rely on a central data collection point where designated staff analyze the data. use of such a system requires good data transmission systems. output is as important as input. collecting data without dissemination of results is a sterile exercise and tends rapidly to demotivate those who are collecting the data. there are some important points to consider: • the results of surveillance must be presented in a readily comprehensible form. • surveillance reports should be produced regularly and widely distributed to aid agencies, and to national and international governments and organizations. this will help those involved to understand the overall picture, rather than just that in the area where they are working, and will allow them to take informed decisions about future actions. surveillance systems should be evaluated constantly to ensure that they are working properly, that the data are representative, analysis is appropriate and accurate, and that results are being disseminated to where they are needed. the public health aspects of communicable disease control can be broadly divided into preventive activities (such as vector control and vaccination programs) and the investigation and control of outbreaks and epidemics. experience from many emergencies and disasters has made it possible to identify a number of syndromes or diseases that are most likely to occur in such situations (table . ). this makes it possible to plan activities and interventions on the basis of likely occurrences, even before those involved are present at the scene of the disaster, and to make initial purchases and establish stockpiles of appropriate medicines and equipment. "prevention is better than cure" and proper attention to preventive measures from the earliest stage of the response to the disaster will greatly reduce the risks to the health of the population from infectious disease. a key method of preventing communicable disease is the provision of shelter, adequate amounts of clean water, sufficient safe food, and proper sanitation (latrines and facilities for personal hygiene, clothes washing, and drying). arthropod vectors (mosquitoes, ticks) can be controlled by appropriate spraying programs and also by habitat management (e.g., the removal of places where water can accumulate and mosquitoes breed). provision of bed nets, particularly nets impregnated with insecticide, is effective for reducing infection with agents such as malaria and leishmania. control of rodents, by proper control of rubbish, by rodent proofing food stores, by attention to domestic hygiene and by use of rodenticides, will reduce the risks of transmission of rodent-borne diseases such as plague and lassa fever. medical waste includes laboratory samples, needles and syringes, body tissues, and materials stained with body fluids. this requires careful handling, especially the sharps, as infectious agents such as those causing hepatitis b and c, hiv and aids, and viral hemorrhagic fevers can be transmitted by these materials. used sharps should be disposed of into suitable containers (proper sharps boxes are ideal but old metal containers such as coffee or milk powder tins are adequate). medical waste should ideally be burned in an incinerator. this should be close to the clinic or hospital but downwind of the prevailing wind. a -l oil drum can be used for this purpose with a metal grate half way up and a hole at the bottom to allow in air and for the removal of ash. larger-scale and more permanent incinerators can be constructed if necessary. burning pits can be used in emergency. if burning is not possible items should be buried at least . m deep. this is more suitable than burning for large items of human tissue such as amputated legs. ensure there is no risk of groundwater contamination. a few others, such as malaria and other vector-borne diseases (e.g., typhus and leishmaniasis), are also likely to occur but are region specific. tb and hiv or aids can also cause major problems in the longer term this is a complex process involving not just considerations of infection risk but also legal, sociocultural, and psychological factors. there are a number of specialist publications which can be of help. after almost every natural disaster, fear of disease has encouraged authorities to dispose rapidly of the bodies of the dead, often without identifying them, and this sometimes seems almost to take precedence over dealing with the living. however, in sudden impact disasters (such as the indian ocean tsunami in ), the pattern and incidence of disease found in the dead will generally reflect those in the living. the situation is much the same in wars and other long drawn out disasters, although these may affect disease patterns and create vulnerable groups. in fact dead bodies pose little risk to health (with some exceptions listed below) since few pathogenic microorganisms survive long after the death of their host. the diseased living are far more dangerous. the decay of cadavers is due mainly to organisms they already contain and these are not pathogenic. those most at risk are those handling the deceased, not the community. the most likely risks to them are as follows: mortuary facilities may need to be provided where the dead can be preserved until appropriate legal proceedings have been undertaken and where relatives, etc., may easily attend to identify and claim the deceased. cold stores and refrigerated vehicles can be used as temporary mass mortuary facilities. alternatively such facilities can be provided in buildings, huts, or tented structures, but refrigeration will be needed. the dead must always be treated with dignity and respect. as far as possible the appropriate customs of the local population or the group to which the deceased belonged should be observed. if the dead have to be buried in mass graves then the layout of the cemetery must be carefully mapped to facilitate exhumation if needed. when an individual may have died of a particularly dangerous infection, then body bags should be used (and also for damaged cadavers). in general, bodies should be buried rather than cremated (as exhumation for purposes of identification may be needed). bodies should be buried at least . m deep or, if more shallowly, should have earth piled at least m above the ground level and . m to each side of the grave (to prevent access by scavengers and burrowing insects). disinfectants such as chloride of lime should not be used. new burial sites should be at least m from drinking water sources and at least . m above the saturated zone. vaccination programs are an essential part of disease prevention. information about existing vaccination programs must be obtained during the assessment process and this should include information from external assessors (e.g., who, unicef, ngos) as to the effectiveness of the vaccination programs that have been undertaken in the past. it cannot be assumed that simply because children have received vaccines that these vaccines were effective. measles kills large number of children in developing countries and is one of the greatest causes of morbidity and mortality in children in refugee and idp camps. mass vaccination of children between the ages of months and years should be an absolute priority during the first week of activity in humanitarian situations and can be conducted with the distribution of vitamin a. a system for maintaining measles immunization must be established once the target population has been covered adequately in the initial campaign. this is necessary to ensure that children who may have been missed in the original campaign, children reaching the age of months, and children first vaccinated at the age of - months who must receive a second dose at months of age are all covered. some of the children vaccinated during such a mass campaign may have been vaccinated before. this does not matter and a second dose will have no adverse effect. it is essential to ensure full coverage against measles in the population. other epi vaccinations for children are not generally included in the emergency phase because they can only prevent a minor proportion of the overall morbidity and mortality at that stage. however, should specific outbreaks occur then the appropriate vaccine should be considered as a control measure. vaccination programs require the following: • appropriate types of vaccines. • appropriate amounts of these vaccines. • equipment (needles, syringes, sterilization equipment, sharps disposal). emergency immunization kits, including cold chain equipment, are available from a number of sources, including unicef and some ngos (e.g. msf). • logistics (transport, cold chain). • staff: a vaccination team may be quite large. it must include the following personnel: -a supervisor. -logistics staff. -staff to prepare and administer vaccines. -record keepers. -security staff (to maintain order and control crowds) may also be needed. maintenance of the cold chain is particularly important. this is the system of transporting and storing vaccines within a suitable temperature range from the point of manufacture to the point of administration. the effectiveness of vaccines can be reduced or lost if they are allowed to get too cold, too hot, or are exposed to direct sunlight or fluorescent light. careful note should be taken of the conditions needed to transport different vaccines because these can vary. the essential cold chain equipment needed to transport and store vaccines within a consistent safe temperature range includes the following: • dedicated refrigerators for storing vaccines and freezers for ice packs (fridges and freezers powered by gas or kerosene are available as alternatives to electric machines, and solar-powered fridge/freezer combinations specially designed for vaccine storage are also available) • a suitable thermometer and a chart for recording daily temperature readings if possible, vaccines should be stored in their original packaging because removing the packaging exposes them to room temperature and light. check the temperature to ensure the vaccines have not been exposed to temperatures outside the normal storage ranges for those vaccines (see table . ). max. storage time at the different levels: primary, months; region, months; district, month; health center, month; health post, daily usemax. month diluents must never be frozen. freeze-dried vaccines supplied packed with diluent must be stored between + and + °c. diluents supplied separately should be kept between + and + °c vaccines must be kept at the correct temperature since all are sensitive to heat and cold to some extent. all freeze-dried vaccines become much more heat-sensitive after they have been reconstituted. vaccines sensitive to cold will lose potency if exposed to temperatures lower than optimal for their storage, particularly if they are frozen. some vaccines (bcg, measles, mr, mmr, and rubella vaccines) are also sensitive to strong light and must always be protected against sunlight or fluorescent (neon) light. these vaccines are usually supplied in dark brown glass vials, which give them some protection against light damage, but they must still be covered and protected from strong light at all times. only vaccine stocks that are fit for use should be kept in the vaccine cold chain. expired or heat-damaged vials should be removed from cold storage. if unusable vaccines need to be kept for a period before disposal (e.g., until completion of accounting or auditing procedures) they should be kept outside the cold chain, separated from all usable stocks and carefully labelled to avoid mistaken use. diluents for vaccines are less sensitive to storage temperatures than are the vaccines with which they are used (although they must be kept cool), but may be kept in the cold chain between + and + °c if space permits. however, diluent vials must never be frozen (kept in a freezer or in contact with any frozen surface) as the vial may crack and become contaminated. when vaccines are reconstituted, the diluent should be at same temperature as the vaccine, so sufficient diluent for daily needs should be kept in the cold chain at the point of vaccine use (health center or vaccination post). at other levels of the cold chain (central, provincial, or district stores) it is only necessary to keep any diluent in the cold chain if it is planned to use it within the next h. freeze-dried vaccines and their diluents should always be distributed together in matching quantities. although the diluents do not need to be kept in the cold chain (unless needed for reconstituting vaccines within the next h), they must travel with the vaccine at all times, and must always be of the correct type, and from the same manufacturer as the vaccine that they are accompanying. each vaccine requires a specific diluent, and therefore, diluents are not interchangeable (for example, diluent made for measles vaccine must not be used for reconstituting bcg, yellow fever, or any other type of vaccine). likewise, diluent made by one manufacturer for use with a certain vaccine cannot be used for reconstituting the same type of vaccine produced by another manufacturer. some combination vaccines comprise a freeze-dried component (such as hib) which is designed to be reconstituted by a liquid vaccine (such as dtp or dtp-hepb liquid vaccine) instead of a normal diluent. for such combination vaccines, it is again vital that only vaccines manufactured and licensed for this purpose are combined. note also that for combination vaccines where the diluent is itself a vaccine, all components must now be kept in the cold chain between + and + °c at all times. as for all other freeze-dried vaccines, it is also essential that the "diluent" travels with the vaccine at all times. the effectiveness of a vaccination program will need to be assessed. the program can be evaluated both by routinely collected data and, if necessary, by a survey of vaccination coverage. routine data on coverage is obtained by comparing the numbers vaccinated with the estimated size of the target population (and clearly depends on accurate assessment of the latter). a coverage survey requires the use of a statistical technique called a two-stage cluster survey details of which can be found in the appropriate who/epi documents. information about the effectiveness of the campaign should be obtained from routine surveillance of communicable disease. if, for example, large number of measles cases continue to occur, or there is an outbreak, then data on coverage should be reexamined. if this is shown to be good (over %) then the efficacy of the vaccine must be suspected. if the field efficacy is below the theoretical value % (for measles vaccine -data on efficacy of other vaccines can be obtained online) then possible causes of a breakdown in the vaccination program must be investigated (failure of the cold chain, poorly respected vaccination schedule). methods for measuring vaccine efficacy can be found in the who/epi literature. mass chemoprophylaxis for bacterial infections such as cholera and meningitis is not usually recommended except on a small scale (for example, the use of rifampicin may be considered to prevent the spread of meningococcal meningitis among immediate contacts of a case), but the difficulties of overseeing such activities and the risks of the development of antibiotic resistance outweigh any benefits that might be gained. the use of chemoprophylaxis for malaria must be undertaken with care. it may be indicated for vulnerable groups of refugees/idps (for example, children and pregnant women) arriving in an endemic area, particularly if they come from a nonmalarious area, but care must be taken to provide drugs to which the local strains of malaria are sensitive. the spread of resistance means that many of the standard drugs are ineffective and the replacements are both costly and may have unwanted side effects. public health education and information activities play a vital role in disease prevention. vaccination programs will not work unless there is acceptance by the public of the necessity for such programs. individuals must be informed as to why these programs are necessary and also where and when they need to take their children for vaccination. such activities are also essential to inform people about particular health programs (for example, feeding programs or vector control programs) and about the steps they can take to protect their health and that of their families (e.g., good hygiene). information can be propagated in many ways: staff who are trained in this type of activity therefore play a key role in disease prevention. heath education also requires transport and equipment (such as video or film projectors, screens, generators, blackboards, etc.). details of the treatment of individuals for various infectious diseases and the facilities needed are covered elsewhere in this book and in many textbooks covering disasters and disease response. in terms of the population aspects of the treatment of disease, important requirements are to ensure that there are • appropriate laboratories (microbiological, parasitological, hematological, biochemical) available to confirm diagnoses and monitor treatment. • adequate supplies of appropriate antimicrobial agents available and the facilities to transport these, store, and distribute them under appropriate conditions (e.g., controlled temperature), together with relevant instruction for use. the provision of laboratory facilities in emergencies is usually limited to basic tests such as those for malaria. more advanced tests, including identification of microorganisms and the determination of antimicrobial sensitivities, require more sophisticated facilities. these may be available in the affected country but are unlikely to be operating in the disaster-affected area. it is more likely that specimens will have to be transported to laboratories abroad. collection of specimens requires appropriate equipment. this will include items such as swabs, transport media, needles, syringes, or vacum sampling systems for blood sampling, different blood collection bottles (with and without anticoagulants) and other sterile specimen tubes, and containers for faeces and urine. transporting specimens must be done safely, and packing specimens for shipment requiring specially trained personnel. treatment of disease requires good supplies of appropriate antimicrobial agents. it is important to ensure that the agents chosen are suitable for use in the area. it is common for doctors in affected areas to ask for the latest therapeutic agents. however, these agents, although effective, are often expensive and not part of the normal treatment programs in the region. the local doctors may not therefore be familiar with the use of these agents, nor may laboratories be capable of monitoring their use. it is better to use funds, which are often limited, to supply larger amounts of older (generic) agents. one caveat is the possibility that regular use may have allowed resistance to certain agents to develop in a country. data on this may be available from local surveillance records. antimicrobials should always be supplied with relevant guidelines in a language that can be understood locally. if local laboratories are unable to test microbes for resistance to antimicrobials, isolates or specimens should be sent as soon as possible to appropriate reference laboratories for testing. outbreaks of communicable disease may occur before preventive measures can take effect or because the measures are in some way inadequate or fail. an epidemic is generally defined as the occurrence in a population or region of a number of cases of a given disease in excess of normal expectancy. an outbreak is an epidemic limited to a small area (a town, village, or camp). the term alert threshold is used to define the point at which the possibility of an epidemic or outbreak needs to be considered and preparedness checked. the areas where vaccination campaigns are a priority need to be identified and campaigns started. the term epidemic (outbreak) threshold is used to define the point at which an urgent response is required. this will vary depending upon the disease involved (infectiousness, local endemicity, transmission mechanisms) and can be as low as a single case. infections where a single case represents a potential outbreak include the following: infections where the threshold is set higher, usually based on long-term collection of data, and will vary from location to location, include the following: • human african trypanosomiasis • visceral leishmaniasis a surveillance system that is functioning well should pick up the signs that an outbreak or epidemic is developing and should therefore allow time for measures to be introduced that will prevent or limit the scale of the event. however, this may not always work and it is essential therefore that plans are made to combat outbreaks or epidemics. in addition to the establishment of surveillance, outbreak preparation involves the following: • preparing an epidemic/outbreak response plan for different diseases covering the resources needed, the types of staff and their skills that may be needed and defining specific control measures. • ensuring that standard treatment protocols are available to all health facilities and health workers and that staff are properly trained. • stockpiling essential supplies. this includes supplies for treatment, for taking and shipping samples, other items to restock existing health facilities and the means to provide emergency health facilities if required. • identifying appropriate laboratories to confirm cases and support patient management, make arrangements for these laboratories to accept and test specimens in an emergency, and set up a system to ship specimens to the laboratory. • identifying emergency sources of vaccines for vaccine-preventable diseases and make arrangements for emergency purchase and shipment. ensure that vaccination supplies (needles, syringes, etc.) are adequate. make sure the cold chain can be maintained. • identifying sources for other supplies, including antimicrobials, and make arrangements for emergency purchase and shipment. if the number of reported cases is rising, is this in excess of the expected number? ideally work with rates rather than numbers (see above) because (for example) the number of cases in a refugee camp could increase if the number of people in the camp increases without an outbreak occurring. verify the diagnosis (laboratory confirmation) and search for links between cases (time and place). laboratory confirmation requires the collection of appropriate specimens and their transport to an appropriate laboratory. in the case of a limited outbreak this team should be set up by the lead agency with membership from other relevant organizations, including moh, who, other un organizations, ngos, etc. in the case of an epidemic the moh will probably take the lead or may ask who or another un agency to do so. the team will need to include a coordinator, and specialists from the various disciplines needed to control the outbreak. this may include health workers, laboratory staff, water and sanitation, vector control, and health education specialists, representatives of the moh or other local health authorities, representatives of local utilities (e.g., water supply), representatives of the police and/or military, and representatives of the local community. this team should meet at least once a day to review the situation and define the necessary responses. it has additional responsibilities, including implementing the response plan, overseeing the daily activities of the responders, ensuring that treatment protocols are followed, identifying resources (both material and human) to manage the outbreak and obtaining these as necessary, and coordinating with local, national, and international authorities as required. the team should also act as the point of contact for the media. a media liaison officer should be appointed and all media contact should be through this individual. this will allow team members to refer media representatives to a central point and reduce interference with their activities. it will also ensure that a consistent message based on the most complete data is given to the media. the appropriate national authorities should be informed of the outbreak. in addition to their responsibilities to their own population and to any refugees within their borders, they have a responsibility under the revised international health regulations ( ) to report outbreaks of certain diseases. these include four diseases regarded as public-health emergencies of international concern: • smallpox • polio (wild-type) in some cases, member states must report outbreaks of additional diseases: cholera, pneumonic plague, yellow fever, viral hemorrhagic fever, and west nile fever, and other diseases that are of special national or regional concern (e.g., dengue fever, rift valley fever, and meningococcal disease). once the diagnosis has been confirmed and the causative organism identified, then there are a number of steps that must be taken in addition to continuing to treat those affected: • produce a case definition for the outbreak. this is primarily a surveillance tool that will reduce the inclusion of cases that are not part of the outbreak and prevent dilution of the focus and activities of the main control effort. • collect and analyze descriptive data by time, person, and place (time and date of onset, individual characteristics of those affected -age, sex, occupation, etc., location of cases). plot the distribution of the cases on a map (can help locate source(s) of an outbreak and determine spread) and plot outbreak curves (which will help estimates of how the outbreak is evolving). • determine the population that is at risk. • determine the number of cases and the size of the affected population. calculate the attack rate. • formulate hypotheses for the pathogen about the possible source and routes of transmission. • conduct detailed epidemiological investigations to identify modes of transmission, vectors/carriers, risk factors). • report results and make recommendations for action. the two main statistical tools used to investigate outbreaks are as follows: • case-control studies in which the frequency of an attribute of the disease in individuals with the disease is compared to the same attribute in individuals without the disease matched in terms of age, sex, and location (the control group) • cohort studies in which the frequency of attributes of a disease is compared in members of a group (for example, those using a particular feeding center) who do or do not show symptoms however the design and methods involved in such studies are often too complex for the austere environment of conflict and disaster. • implement prevention and control measures specific to the disease organism (e.g., clean water, personal hygiene for diarrheal disease) • prevent infection (e.g., by vaccination programs) • prevent exposure (e.g., isolate cases or at the least provide a special treatment ward or wards) • evaluate the outbreak detection and response -were they appropriate, timely, and effective? • change/modify policies and preparedness to deal with outbreaks if required • what activities are needed to prevent similar outbreaks in the future (e.g., improved vaccination programs, new water treatment facilities, public health education, etc.)? • produce and disseminate an outbreak report. the report should include details of the outbreak, including the following: -cause -duration, location, and persons involved -cumulative attack rate (number of cases/exposed population) -incidence rate -case fatality rate -vaccine efficacy (if relevant) (no. of unvaccinated ill − no. of vaccinated ill/no. of unvaccinated ill) -proportion of vaccine-preventable cases (no. of vaccine-preventable cases/no. of cases) -recommendations this is an easy-to-use tool which is of great value for handling epidemiological data and for organizing study designs and results, which can be downloaded free of charge from the internet. it is produced by the centers for disease control (atlanta) and is a series of microcomputer programs which can be used both for surveillance and for outbreak investigation and includes features used by epidemiologists in statistical programs, such as sas or spss, and database programs such as dbase. public health action in emergencies caused by epidemics. geneva: who, . cdc atlanta. case definitions for infectious conditions under public health surveillance updated guidelines for evaluating public health surveillance systems epidemiology for the uninitiated communicable disease control in emergencies -a field manual last jm (ed). dictionary of epidemiology medicins sans frontieres. refugee health -an approach to emergency situations geneva: international committee of the red cross sphere project. humanitarian charter and minimum standards in disaster response. geneva: the sphere project key: cord- - o g q authors: polychronakis, ioannis; riza, elena; karnaki, pania; linos, athena title: workplace health promotion interventions concerningwomenworkers' occupational hazards date: journal: promoting health for working women doi: . / - - - - _ sha: doc_id: cord_uid: o g q nan in the european labor market, women today constitute an increasing part of the working population, equaling about percent of the european workforce (european agency for safety and health at work a) as a result of their dynamic entrance in the labor market during the last few decades. while women have occupied posts even in professions that so far have been considered as "traditionally male," the european labor market retains a high degree of segregation regarding women's participation rates in certain occupational sectors (european agency for safety and health at work a; ) . the european union (eu) has so far applied a gender-neutral approach (european agency for safety and health at work a; ) to policies and legislation concerning occupational safety and health (osh) to comply with world health organization (who) guidelines for equality in health standards and access to health service. however, this approach does not seem to suffice for effectively meeting gender-specific issues of occupational hygiene and safety that have emerged concerning female workers in particular. the female working population carries certain characteristics that have to be taken into consideration through the process of design and implementation of osh policies, because their interaction with the occupational environment may produce additional hazardous effects for women employees: women's workday concerns arising from their roles as mothers, spouses, or carers for the elderly, add an extra load on the mental and physical fatigue they sustain in their workplace (artazcoz et al. ; artazcoz, borrell & benach ) . everyday household tasks amount to hours of unpaid overtime on top of the -hour working day, increasing their total physical and psychological strain. as a consequence, women workers are more easily affected by burnout effect or suffer more frequently from work-related stress than their male colleagues, who continue to participate significantly less than women in house tasks. working conditions in terms of ergonomics, working pace, managing heavy workloads, and using tools or personal protective equipment (ppe) (tapp ; murphy, patton, mello, bidwell, & harp ) are often designed according to the size and the physical strength of an average male worker. this is a consequence of the fact that many occupational sectors were, until recently, almost exclusively staffed by men, and even today employ an overwhelming majority of male workers. despite the increase in the participation of female workers in many professional fields, the high cost of adequate interventions still constitutes a forceful barrier to adjusting the modern workplace to female employee's needs for health and safety. because women of child-bearing age constitute a significant part of the female workforce, the protection of women's reproductive health is an issue of great concern for eu policymakers, in terms of legislation. this applies to factors and working conditions that both directly and indirectly influence the female reproductive system, including fertility (biological, physical, or chemical hazards-e.g., endocrine disruptors that affect women's ability to conceive), pregnancy (detrimental factors for the foetus during intrauterine development), and lactation. one also has to underline the fact that pregnant women are in need of specially designed ergonomic workplaces (niedhammer, saurel-cubizolles, piciotti & bonenfant ) , that consider changing physical and biological conditions and needs throughout the gestation and post-partum period. biological predisposition determines that women employees have reduced physical strength in comparison with their male colleagues (hooftman, van der beek, bongers, & van mechelen ) . this fact creates a comparatively higher burden for female workers who perform the same tasks as men, and creates a greater risk for musculoskeletal strain. furthermore, women's reduced average muscle force places them in an unfavorable position in cases of bullying and physical violence at their workplace, both from co-workers or the public (e.g., psychiatric ward nurses). women workers are still a minority group in certain professional fields (e.g., construction, mineral extraction, heavy industry), and in most cases they remain in lower managerial positions in comparison with men. under these circumstances, women employees have limited control over administrative decisions (european agency for safety and health at work ) concerning occupational health and safety, and often lack access to the appropriate communication channels to report cases of bullying, mobbing, or even sexual harassment-especially when superiors are involved. in certain areas of industrial production (e.g., the textile industry), the female working population consists predominantly of immigrant workers with poor literacy skills, or difficulty communicating. this language barrier may, in some situations, cause work-related accidents, as well as expose workers to occupational hazards due to misconception or ignorance of safety instructions or warning labels and signs. women in europe present higher percentages of part-time employment than men, as shown in figures . and . . in many occupational sectors (e.g., cleaning industry, cashiers), the overwhelming majority of women work part time. in addition, female employees show a higher turnover rate during their career and seem to spend shorter periods, on average, in the same position (mcdiarmid & gucer ) . because of this effect, women's occupational diseases are, in many cases, significantly underreported, introducing a systematic bias in many studies on occupational hazards and creating the misperception that female workers generally occupy safer jobs. to make matters even worse, women in this kind of unstable employment pattern have, in most cases, only limited access to occupational health services and workplace health promotion activities, even though they constitute a high-priority group for similar interventions. it should be underlined, however, that under no circumstance does this genderspecific approach lead to the false conclusion that women workers constitute a (jouhette & romans ) high-risk group requiring preferential treatment over issues of occupational safety and health in comparison to male workers. such a misinterpretation could cause unacceptable discrimination against women and, in some cases, their exclusion from occupational sectors where female workers have for a long time now proven their worthiness as employees. even though available research data in the literature may suggest that certain traits or characteristics connected with gender could possibly influence the occupational risk of female employees, they fail to identify occupational hazards that are selectively or exclusively harmful to women. at this point, it is useful to categorize all gender-related parameters that have been identified as distinguishing occupational health and safety issues between male and female workers. according to previous studies, three fields of possible gender influence (kennedy & koehoorn ) on estimated occupational risk can be identified. because of job and task segregation observed among the european workforce, osh studies based on occupational categorization alone have been insufficient in assessing potential health risks for women, because their tasks may vary significantly from men's even if they carry the same professional title (Östlin ) . women follow different time patterns of exposure through part-time or shift work, and usually carry out tasks requiring more precise, repetitive movements than male workers (hooftman et al. ; stellman ) . • female workers have smaller (on average) body dimensions (hooftman et al. ) , which differentiates their occupational exposure: a. in professions involving manual handling, greater physical workload may be required by women to perform the same tasks as men. b. in cases of chemical exposure through the skin, the female body provides smaller available surface for absorption. c. protective equipment is often ineffective for women employees (protective clothing, gloves, masks, and respirators) (han dh ) . protective equipment originally designed for male workers does not fit appropriately to the shape and size of the female body and does not fully prevent exposure to hazardous agents. • under normal conditions, women present lower alveolar ventilation rate and cardiac output (brown, shelley & fisher ) , which reduces the input rate of volatile chemicals into their body • in the case of benzene (a proven carcinogen) and other volatile organic compounds (vocs), it has been experimentally demonstrated that women present higher blood/air partition coefficients (brown et al. ) (greater blood / air concentration fraction), increasing the amount of chemicals diffused from alveoli to the blood compartment • concerning the metabolism of chemical compounds, potential gender-related disparities in enzymic activity (gandhi, aweeka, greenblatt & blaschke ) (e.g., cytochromes p , transporting enzymes) have been reported, although research results are contradictory • in the case of exposure to metals, women appear to absorb greater amounts of cadmium through digestion, possibly due to a common absorption pathway for iron and cadmium (vahter, berglund, Åkesson & lidén ) (especially for menstruating women with low body-iron storage) • chemicals absorbed into the bodies of women workers are distributed in a relatively smaller body mass than men, because their body mass index (bmi) is lower (gandhi et al. ) . as a further consequence: a. women present a relatively higher organ blood flow, which increases the rate at which chemical substances circulating in blood compartment are delivered to the tissues. b. women's renal clearance (gandhi et al. ) (a parameter that is directly related to body weight) is slower in comparison with men's, and therefore their capacity to excrete toxic compounds, as well as their metabolites, through daily production of urine is low. • bodily distribution of chemicals in women also differs in regard to their concentration in plasma. experiments on gender influence on the distribution of certain drugs, indicate that (gandhi et al. ): a. plasma volume is generally lower in females (the same total-body chemical burden may produce more toxic plasma concentrations in women). a. the concentration of certain binding proteins for drug metabolites or other chemicals in plasma depends heavily on hormonal status-especially estrogens (e.g., pregnancy, menstrual phase, and menopause). • the female body carries a greater proportion of adipose tissue than that of males (brown et al. ; gandhi et al. ) , and as a result it demonstrates a different pharmacokinetic response to lipophilic metabolites (e.g., prolonged retain and increased metabolism of benzene). • in professions involving exposure to inorganic lead, blood concentrations do not provide a reliable criterion of chronic exposure in the case of female employees. as the metal gradually accumulates in the bone tissue, demineralization of women's skeleton during periods of increased bone turnover (as in pregnancy or menopause) releases significant quantities of lead into their bloodstream (vahter m et al. ) . • women present different social and dietary habits, such as smoking (e.g., cadmium absorption) (vahter m et al. ) and alcohol or coffee consumption (mcgovern ) , which may act as modifiers to environmental exposures • the use of chemical substances for household tasks (e.g., cleaning products), hobbies (e.g., fertilizers in gardening), or other activities involving application of potentially harmful agents (including cosmetics and artificial hair dyes) may subject women to further exposure outside their daily work hours • wearing jewelery is an additional nonoccupational source of skin exposure to metals for women (e.g., nickel) (vahter m et al. ) , increasing the burden of metal-induced occupational dermatitis for women employees • female employees in occupations involving manual tasks may also have to sustain additional workloads arising from family demands, especially in large families with children under years old, or elderly persons over years old (artazcoz et al. ) , which may contribute to producing symptoms of physical fatigue or musculoskeletal strain. • increased family demands of female workers, combined with strenuous job tasks may also have a serious impact on women's mental health (disturbed work-life balance, inadequate leisure time, lack of personal life) (artazcoz et al. ) • besides the immediate toxic effects of certain metals such as cadmium on humans (affecting both men and women), there is ongoing research on possible estrogenlike activity as well as its potential association with breast cancer through the activation of estrogenic receptors (brama m et al. ) • the manifestation of certain gender-specific cancers (e.g., breast cancer, which occurs almost exclusively in women) seems to involve among others, interaction between genetic expression (e.g. atm tumor suppressors) (mcgovern ) and environmental exposures • the manifestation of autoimmune diseases (highly frequent among the female population) might be triggered or accelerated by substances or agents commonly used in certain professions (as in the case of lupus erythematosus and mercury exposure) (mcgovern ) • the varying composition of the labor force in different occupational sectors may have introduced a significant bias in epidemiological studies concerning occupational hazards for women: a. especially in the heavy industry and construction sectors, which employ almost exclusively male employees, the small minority of women who work alongside their male co-workers in various positions may have been overlooked (niedhammer et al. ) in osh studies, introducing exclusion bias (concerning women workers) because of the difficulties researchers had in finding women employees to participate in their studies. b. on the other hand, women-focused osh research has concentrated on the relatively small number of professions that master the majority of the female work-force. this fact probably explains the relatively large volume of studies on health-care professions (which are easily accessible to research), while women workers remain heavily underrepresented in osh studies in other sectors (messing & stellman mager ) c. the majority of studies that focus exclusively on women workers deal with mental health issues and psychological parameters (messing & stellman mager ; niedhammer et al. ) , while other work-related hazards such as exposure to chemicals, radioactive material, biological factors, electromagnetic fields, noise, or ergonomic factors are either indirectly examined by surveys on mixed working populations (where results are adjusted for gender), or even worse, by generalizing epidemiological evidence of osh conducted among male employees. • the segregation of tasks performed within the same job department or even under the same occupational title, may introduce misclassification bias when the influence of gender on occupational risk is under study. any observed excess risk among women workers (e.g. musculoskeletal injuries) in comparison with men, should not necessarily be attributed to the role of gender, especially when such results are based only on job title (hooftman et al. ). in such cases, further quantification of exposure (job exposure matrices, stratification according to tasks) is essential in determining whether the declination in study results arises from differences in performed tasks, or is truly related to gender-e.g., the excess risk for developing carpal tunnel syndrome in female workers seems to be eliminated in professions with strictly defined tasks (mcdiarmid, oliver, ruser & gucer ) . • other forms of bias related to gender have been identified in the design of clinical, as well as osh, studies: a. an observer error due to adopting "male perspective and way of thinking" (pinn ) in interpreting epidemiological data. b. the "male norm" bias, arising from the use of male workers as standard (pinn ) , even for occupational health and safety issues where both sexes are affected (e.g., occupational cancer). • there are indications that many of the existing studies on women workersespecially those concerning occupational musculoskeletal injury-may suffer from perceptual bias (the increased likelihood of employees to report injuries), or overrating the severity of related symptoms in questionnaire surveys according to the way they perceive their working environment or their degree of job satisfaction (strazdins & bammer ) . taking into account that female workers are generally occupied in less satisfactory, underpaid jobs with repetitivemonotonous tasks (hooftman et al. ) , over-reporting may contribute significantly to the excess risk found by many relevant studies for female employees. • for the majority of female workers employed outside the dangerous industrial or construction sectors, there is little public awareness of the occupational exposures they sustain from their working environment because they usually do not face immediate danger of acute toxic effects or death. this fact may introduce a significant recall bias in relative studies because women workers are either unable to identify potentially harmful agents they have been exposed to, or tend to underestimate the extent of such exposures (e.g., unawareness of types of agents involved in their tasks that may constitute reproductive hazards) (bauer, romitti & reynolds ) . • in mixed working populations, the healthy worker effect appears stronger for male than female employees , which is possibly attributable to the fact that men are hired to perform more physically demanding tasks than women and are therefore subjected to more rigorous selection during the hiring process. the existing research evidence indicates a widely accepted false sense of safety in many of the professional sectors employing predominantly women, which has been recognized in earlier occupational health and safety studies in the united states as the so-called generally recognized as safe (gras) status (mcdiarmid & gucer ) for most of the female professions. this is partially due to the fact that male workers, especially in heavy industry (construction workers, miners, welders, heavy machinery operators), are expected to face a higher number of severe or even fatal incidents or occupational diseases (niedhammer et al. ) , than those in the safe tertiary sector. gras reflects the commonly held belief that certain drugs and chemicals are safe if empirical knowledge obtained by their wide use over a period of years does not indicate they are detrimental to the population. as a consequence, this approach is also adopted in occupational sectors, where such materials have been widely used-the majority of which involve femaledominated professions where, until recently, osh research has been considered nonessential. contemporary evidence-based medicine, however, requires more solid epidemiological data to conclude whether this group of occupations is as safe as is currently presumed. in addition, there is an increasing need to study the possible sideeffects on health from exposure to thousands of chemical compounds present in jobs generally considered as nonhazardous (cleaning agents, drugs, cosmetics, food preservatives). the latter translates as a need to expand the field of occupational health and safety research and place the so-called female professions under a more thorough and systematic investigation. according to official statistics of the european agency for safety and health at work, certain occupational sectors (health professionals, education workers) employ mostly females while the percentage of women in other professions (construction workers, heavy industry) (european agency for safety and health at work ) remains relatively low. figure . presents the distribution of the female working population in different occupational activities, in the european union. for many of the professions where women are highly represented, research has explored specific occupational hazards. in tables . in the health services sector, women are employed in various positions (e.g., nurses, laboratory technicians, emergency room technicians) and face a multitude of occupational risks, some of which are cited in table . . women are also often employed in the education sector, especially in nursery and primary education, and therefore face diverse occupational risks, some of which are specific to the profession (e.g., voice disorders). table . presents some of the related occupational hazards for this category of workers. while affected by many occupational hazards, some of which are cited in table . , women working in the cleaning industry are also disadvantaged due to the fact that (gavana, tsoukana, giannakopoulos, smyrnakis, & benos, ; gyorkos et al., ; nakazono, nii-no, & ishi, ; skillen, olson, & gilbert, ; valeur-jensen et al., ) • vascular problems (kovess-masfety, sevilla-dedieu, rios-seidel, nerriere, & chee, ) of the lower extremities due to extended standing (sandmark, wiktorin, hogstedt, klenell-hatschek, & vingard, ) in upright position • voice disorders due to overuse of vocal chords duff, proctor, & yairi, ; kooijman et al., ; kosztyla-hojna, rogowski, ruczaj, pepinski, & lobaczuk-sitnik, ; roy, ; sliwinska-kowalska et al., ; sulkowski & kowalska, ; thibeault, merrill, roy, gray, & smith, ; williams, ) • exposure to increased levels of noise (behar et al., ) • musculoskeletal problems (fjellman-wiklund, brulin, & sundelin, ; sandmark, ; yamamoto, saeki, & kurumatani, ) (handling and lifting small children in day care centres, physical education teachers, inadequate body posture) • work-related stress (fjellman-wiklund et al., ; zidkova & martinkova, ) • children's or adolescent's violent behavior (lawrence & green, ) • exposure to infectious agents • dermatitis due to direct skin contact with irritating substances (weisshaar et al., ) • dermal infections (staphylococcus, fungi) (mcbryde, bradley, whitby, & mcelwain, ) • inhalation of irritating vapours and airborne micro-particles containing dust or other allergens (j. j. jaakkola & jaakkola, ) • musculoskeletal disorders due to handling or lifting heavy objects, inadequate body posture (balogh et al., ; mondelli et al., ) • fall injuries (stairs, slippery floors) (kines, hannerz, mikkelsen, & tuchsen, ) • workplace violence (chen & skillen, ) • sexual harassment table . food production industry workers workplace hazards • inhalation of airborne allergens emitted from food processing (e.g., artificial dyes, flour, animal proteins) • dermal infections (staphylococcus, b-haemolytic streptococcus, bacillus anthracis, fungi) • dermatitis (allergic or irritating) from skin contact to foods themselves or substances used for their processing (jappe, bonnekoh, hausen, & gollnick, ; kanerva, estlander, & jolanki, ) • exposure to zoonoses (processing animal products) • musculoskeletal disorders (handling and lifting excessive loads, inappropriate body postures, poor ergonomic design of workstations, repetitive strain) (chyuan, du, yeh, & li, ) • injuries (falls due to slippery floors, burns, lacerations from knives or used tools) (courtney et al., ) • exposure to extreme temperatures (cold in refrigerators, excessive heat in kitchens) their occupation is often unregulated, and thus no occupational safety and health services are available to them. the food production sector involves various types of work, from food preparation to packaging, storing, and more, involving mainly biological and chemical hazards due to immediate contact with food. table . presents a non-exhaustive lists of related occupational hazards. a large number of women are employed in the sector of hospitality services (e.g., waitresses, cooks, bar attendants) and are subject to a number of risks, some of which are listed in table . . the textile sector is heavily industrialized, and women working in this sector face many and serious risks, some of which are cited in table . . laundry workers are also faced with heavy tasks such as long hours on their feet, exposure to extreme temperatures, and lifting heavy loads, as can be seen in table . . table . hospitality services industry-restaurant workers' workplace hazards • exposure to extreme temperature conditions (excessive heat in cookers) • musculoskeletal injury due to handling or lifting heavy objects-repetitive movementsstrenuous workload (chyuan et al., ; dempsey & filiaggi, ) • dermatitis induced by skin contact with foods or cleaning agents (jappe et al., ; kanerva et al., ) • dermal infections (skin contact to infected food surfaces, development of fungal infections due to extended exposure to humidity) • injuries (falls due to slippery floors, falling objects, skin lacerations from sharp objects, burns from heat-emitting objects or appliances) (courtney et al., ; horwitz & mccall, ) • inhalation of micro-particles (food-cooking, passive smoking, poor ventilation) (svendsen, jensen, sivertsen, & sjaastad, ) • workplace violence (graham, bernards, osgood, & wells, ) • sexual harassment • work-related stress (low levels of job satisfaction, stressful working conditions) table . textile industry-clothing manufacture workplace hazards • exposure to increased levels of noise (weaving machines) (bedi, ; cardoso, oliveira, silva, aguas, & pereira, ) • increased concentration of fibres, micro-particles and organic solvents (artificial dyes, chemicals used in textile processing) in workplace environment (bakirci et al., ; ghio et al., ) • musculoskeletal injury (poor ergonomic design (choobineh, lahmi, hosseini, shahnavaz, & jazani, ) of the production line, repetitive movements (bjorksten, boquist, talback, & edling, ) , lifting and handling heavy objects) • visual fatigue • injuries (entanglement in moving parts of equipment, skin lacerations by sharp objects) • intense work-related stress (strenuous workload, intense work pace in production lines, low level of job satisfaction) ceramic and pottery workers face a series of specific occupational risks connected with the nature of their profession, as presented in table . . light manufacturing includes many types of industries, employing mainly nonspecialized workers and therefore involving diverse types of exposure. table . presents some of the hazards involved in these occupational activities. (dorevitch & babin, ) • musculoskeletal injury due to poor ergonomic design, handling heavy loads, repetitive muscle strain, vibrations (martinelli & carri, ) • stressful working conditions -strenuous work pace in production lines table . light manufacture workers' workplace hazards • musculoskeletal injury due to poor ergonomic design (equipment, tools and workstations that don't fit the physical dimensions of female workers), handling and lifting heavy loads, repetitive movements (bjorksten et al., ; roquelaure et al., ) • visual fatigue (untimanon et al., ) • exposure to chemical agents (e.g., metals & solvents in electronic circuits manufacture, drug by-products in the pharmaceutical industry) (clapp, ; ladou, ) • stressful working conditions in production lines call center work is a newly developed sector that employs mostly women who are faced with risks such as visual fatigue, musculoskeletal disorders, and other hazards as presented in table . . hairdressing is a female-dominated sector that, until recently, has been regarded as a safe occupation. however, current literature associates this profession with various hazards, some of which are included in table . . the tertiary sector-especially office workers-are faced with hazards arising mainly from poor ergonomic design and poor indoor air quality, as shown in table . . hazards in agriculture are linked mainly to a high risk of injuries and to the use of chemical substances such as pesticides, herbicides, and others, as shown in table . . (best et al., ) (inadequate body postures (osteras, ljunggren, gould, waersted, & bo veiersted, ) , poor ergonomic design (boyles, yearout, & rys, ) ) • vascular problems of the lower extremities due to prolonged standing in upright position • dermal infections (ballas, psarras, rafailidis, konstantinidis, & sakadamis, ; schroder, merk, & frank, ) (skin lacerations from scissors or other sharp tools (moghadam, mazloomy, & ehrampoush, ) , dermal fungi from continuous exposure to humidity) • dermatitis (khrenova, john, pfahlberg, gefeller, & uter, ; perkins & farrow, ) (irritating or allergic) (cavallo et al., ; doutre, ) induced by contact to cosmetics (amado & taylor, ; iorizzo, parente, vincenzi, pazzaglia, & tosti, ; katugampola et al., ; sosted, hesse, menne, andersen, & johansen, ) , artificial hair dyes (belinda thielen, ; rastogi, sosted, johansen, menne, & bossi, ) or even protective gloves (foti et al., ) • allergic asthma (akpinar-elci, cimrin, & elci, ; allmers, nickau, skudlik, & john, ; macchioni et al., ; moscato et al., ) induced by exposure to volatile substances (baur, ; berges & kleine, ; gala ortiz et al., ; hoerauf, funk, harth, & hobbhahn, ; hollund & moen, ; labreche, forest, trottier, lalonde, & simard, ; piipari & keskinen, ) and particles (cosmetics, hair sprays (albin et al., ; montomoli, cioni, sisinni, romeo, & sartorelli, ) , dryers • job-related stress (strenuous working conditions, low job satisfaction) (mcbride, firth, & herbison, ; perry & may, ) • exposure to zoonoses due to close contact with animals or animal products (bacillus anthracis, mycobacterium, brucellosis, viral infections e.g. avian influenza) • exposure to chemical compounds during transportation, storage, mixing or application of fertilizers, pesticides or herbicides (buranatrevedh & roy, ; garcia, ) • exposure to allergens through inhalation or direct skin contact (pollen, animal proteins, fungi) (linaker & smedley, ) • exposure to natural phenomena (extreme heat, frost, thunderstorms, floods) • job related stress (stressful working conditions, job insecurity, low income, low job satisfaction) • violence at the workplace (verbal or physical abuse) • sexual harassment this section will focus on how theories and models of health promotion can be put into practice for the design and implementation of workplace interventions concerning osh issues targeted at female workers. the example that will be used is work-related reproductive disorders. the specific health topic has been selected as an example for three primary reasons: • reproductive disorders have been associated with a wide range of occupational hazards (e.g. physical, chemical, biological agents) • a large number of professions employing women involve exposure to hazards such as those mentioned in the above point • further research is needed on this topic because many of the traditionally female professions considered generally safe may involve unidentified risks for women's reproductive health reproductive hazards constitute a field of increasing interest for occupational hygienists and health professionals across the world. there is little or no information at all about the possible effects on female reproductive health of the vast majority of chemical substances introduced by the thousands every year in industrial production (lawson et al. ) . even in cases of widely used chemicals, the existing literature of their possible detrimental effects on women's reproductive physiology is relatively poor. for most of the agents considered as hazardous for the reproductive system, their causal relationship to problems in human reproduction has not been adequately documented and gender differences in exposure or toxicity have not been thoroughly examined. because female workers constitute a nonhomogenous population of diverse occupational categories, various physical, chemical, and biological exposures are under examination concerning their potential risks on the reproductive health of women. a non exhaustive list of factors under investigation concerning their potential harmful effects on female reproductive health is presented in table . . the precede-proceed model of planning will be used as a framework to guide the diagnostic phase of the suggested intervention (gielen & mcdonald ; green & kreuter ; green, kreuter, deeds & partridge ; national cancer institute b; ransdell. ) . the outline of this theoretical model is presented in figure . . • precede provides the methodological framework for the design of tailored educational interventions targeting specific populations. it is based on the medical model, involving an initial diagnostic approach to the needs of a patient, before prescribing a specific treatment. as an analogy, precede constitutes a tool to design a specific educational plan, according to the identified needs of the target group. • proceed has been an addition to the original model, to further include environmental determinants (e.g., policies, managerial and economic issues) that influence human attitudes towards specific health behaviors. this model follows a reverse course, towards the origin of certain health behaviors to target interventions for the causal factors themselves, rather than just the symptoms. the outline of the process that takes place in nine stages is presented in figure . . for our example, only the diagnostic part of the model will be analyzed. despite the fact that we have already chosen occupational reproductive hazards as our intervention subject in this case, the stage of social diagnosis is supposed to have taken place before making our choice. for any workplace health promotion effort to be effective, the key issue must be tailored according to the needs of the predefined target population. even though women's reproductive health may seem like a scientifically important field of intervention, our target group of women employees may not consider it to be a highpriority issue-either because they consider having more important health problems or because they are not adequately informed on the possible impact of similar disorders on their personal health status. the main focus of health professionals at this stage is to investigate: • the target group's perception of their quality of life • the most important determinants of their quality of life (e.g., career, family, health) • their expectations and concerns about their health status • whether reproductive health issues are considered an important enough factor for women that an intervention through a whp program is valuable the focus of health professionals during this phase is to identify-through analyzing epidemiological evidence-the impact of the specific problem on the predefined target group (e.g., female workers in a factory, women employed in a specific profession). furthermore, this procedure aims at prioritizing the specific subgroups that face the highest risk of exposure to reproductive hazards and need more immediate preventive measures. this stage includes: • identification of work-related parameters, as well as individual behaviors that may influence the reproductive health status of women employees • evaluation of specific indicators of reproductive health disorders in our target population. some of these indicators are listed in table . one of the specific interests of health professionals at this stage is to locate groupings of reproductive disorder indicators in certain subgroups (specific job tasks, worksite-specific reproductive hazards) of the population, to prioritize them as intervention groups (e.g., focusing a whp program for the prevention of reproductive disorders on oncology unit nurses in case they present higher incidence of congenital defects compared to the rest of health care personnel) table . potential indicators of reproductive disorders (lawson et al. ) . increased infertility rates among women of a specific industry . a prolonged conception period among female workers . frequent reports of menstrual disorders and early menopause by female employees in the company's medical files . male/female ratio of births . reported pregnancy complications among employed pregnant workers (e.g., diabetes, hypertension, pre-eclampsia, etc.) . reduced (or increased) average birth-weight of infants . increased rates of pre-term deliveries (and miscarriages) . number of sick-leave days among pregnant employees (for problems related to pregnancy) . increased rates of congenital defects among infants of female workers . increased incidence of neoplasms of reproductive organs among employed women it is imperative during the initial design of a tailored whp intervention program for the prevention of occupation-induced female reproductive disorders, to incorporate a set of behavioral and environmental change indicators that serve as general objectives for the program. whp professionals, prior to the development of an intervention plan, should conduct behavioral and environmental diagnosis to identify existing key issues concerning osh attitudes and beliefs and practices in the organization (employees, executives, and company administration) and the safety status of facilities, procedures, and equipment. these key issues may include (state of alaska ): • personal accountability: this parameter is crucial for the success or failure of any prevention program, both on worksites and in the general population. it is important to adjust the program's aims and methods according to women's perceptions of its personal influence on their health status. female employees should be able to recognize their personal responsibility and contribution to the effective implementation of the preventive measures and practices by the completion of the whp intervention. • attitude towards change: a key component for the design of an effective intervention prevention program is taking into account the degree to which women agree with the proposed changes (safety behavior, practices, osh regulatory environment), so that invention methods can be modified accordingly. at this stage, therefore, health professionals should evaluate the awareness status and the ability of female employees to adopt the desired safety practices introduced by the whp program on both personal and collective levels to determine the kind of messages and strategies appropriate for the specific population. • participation: one of the primary targets of the whp intervention is to achieve a high degree of participation in the program's activities, as it is one of the key elements that significantly influences results. it is important at this stage to recognize and alleviate barriers that are driving women to abstain from similar programs. furthermore, there is a need to identify the subgroups of female workers where the focus of the intervention needs to be to promote their involvement. • occupational hazard identification: apart from recognizing that female workers are at a high risk for reproductive disorders, the whp program should also concentrate on specific protective measures and proposals for these groups of employees. it is essential, therefore, to identify and record existing working conditions of women in the specific organization in detail, to determine their possible detrimental effect on the reproductive physiology of those same women, and assess the existent osh status of their job tasks. this process includes recording: . procedures (production line, manual tasks, strenuous work pace, extreme climate conditions, emission of fumes/particles, and stressful conditions) . hazardous agents (physical, chemical, and biological) involved in female workers' tasks or working environment . equipment used in specific tasks (radiation sources, vibrating parts, electromagnetic fields) . existing protective measures (ventilation systems, separate mixing chambers for chemicals, lifting devices for manual handling, radiation shields, ppe, rotation of night shift workers, etc.) for women employees . potential for osh improvement (substitution of procedures or agents, automatization of tasks, amelioration of working conditions, change of job post, or rotation of workers) this part of the diagnostic process involves the identification of the educational needs of female employees, as well as the structural changes that are needed in the specific organization to effectively introduce the whp interventions for the protection of women worker's reproductive health. this process will be used to shape our strategic approach towards the target population, through the analysis of determinants of compliance with safety practices at individual, collective, and organizational levels. three categories of such factors may be identified-namely, predisposing, enabling, and reinforcing factors, that will be further analyzed: predisposing factors: health professionals may recognize multiple potential fields of intervention on which to focus the whp program: the whp program may introduce certain interventions to promote the desirable change to compliance in osh practices. • personalized information on female reproductive system and occupational risks involved • health awareness building on reproductive health issues and their importance • wide dissemination of existing scientific evidence on reproductive hazards for women employees (population awareness) • creation of peer support systems among groups of women workers to promote compliance with safety procedures • detailed recording of job tasks for female employees and identification of sources of exposures to known or potential reproductive hazards • introduction of specific safety guidelines and policies for the prevention of reproductive disorders • establishment of clear communication channels between employees and administration to report their concerns or personal experience on relative issues • improvement of the existing surveillance system for reporting suspicious cases among women workers reinforcing factors whp program officials may utilize numerous tactics to support the desired prevention strategy at this field. • provision of access to supplementary information resources on reproductive health issues and available prevention methods to the population of women employees • application of periodic follow-up sessions and use of frequent reminders (letters, telephone calls, e-mail messages) to retain an increased awareness level among female workers • dispensation of easily accessible screening services for exposure of employees to reproductive hazards • building a support network for the compliance of individuals with occupational safety practices by appointing safety committees that include female workers at risk for reproductive hazards • organization of group discussions among workers of specific occupational categories to share common experiences and concerns on related issues • projection of specific employees as models of good conduct in osh issues involving reproductive hazards prevention • presentation of statistics on results of exposure level reduction, or outcomes, if available (e.g., reduction on rate of miscarriages) organizational level- • active participation of women employees in the decision-making process concerning applied safety policies in the company • representation of female workers from different occupational sectors within the organization in administrative issues regarding the design of workstations and job tasks, and the introduction of new technologies, materials, and procedures • introduction of incentives for the compliance of employees with safety policies whp professionals should conduct this final diagnostic procedure before the implementation of the prevention program, to determine whether the program's scope and activities are compatible with the administrative and policy framework of the organization. the main issues to be identified at this stage are: • whether the policies and safety regulations related to potential reproductive hazards are in accordance with the program's requirements and the existence of requisite modifications or complementary arrangements • whether the program introduces any interventions that are in conflict with the organization's operational framework • whether the selected form of intervention (information campaign, skill building sessions, group activities) is appropriate for the existing company culture in osh issues • which of the existing structures and activities in the organization are useful to the program's strategic planning. some examples of similar structures and activities are presented in table . . • whether the company's administration is sufficiently flexible to adopt the participatory decision model proposed by the program for the resolution of osh issues • whether the organization's field of activities and operational status allows for alternative practices, procedures, and materials. table . sites an indicative list of similar practices and procedures. . systematic record of occupational medical history of workers . safety committees appointed by company's employees . trade-union department specialized in osh issues for female employees . registry of recognized occupational reproductive disorders . official forms for reporting employees remarks on working conditions and related hazards . detailed registry of materials, substances and processes utilized in each department of the organization (toxicity, carcinogenicity, potential for endocrine disrupting activity) . regular group meetings among workers and administration representatives . periodic screening of working population for hazardous occupational exposures the primary concern of whp professionals in the design of an educative intervention for women workers is to provide a tailored program according to the specific target population and its educational needs. the selection of a specific approach for this educational needs assessment depends heavily on the available resources (staff, time, expenditure limitation) of the program. listed below are some of the available techniques, and the form in which they may be employed, to obtain related information from the female workers' population (national cancer institute a; pfizer ; younger, wittet, hooks & lasher ) : women employees can be accessed individually, either at their worksite or through telephone or internet surveys, to fill in specifically designed questionnaires. some of the questions that may be included in such a questionnaire are listed in table . . this approach involves two-hour sessions of small work groups of six to ten women employees who testify their individual concerns, experiences, and percep- tions on work-related reproductive health issues. the activity takes place under the continuous supervision of an expert facilitator (health professional). the workgroup is selected on the basis of common socioeconomic and ethnic characteristics (e.g., representation of low literate immigrant female workers) as well as their specific job tasks. the application of this technique offers the whp program a more comprehensive insight into the target population profile (younger et al. ) , as well as the specific needs of certain special subgroups of womens workers (e.g., effective approach and training techniques, use of appropriate educative material). women employees are interviewed in the form of open-ended questions, where they are encouraged to identify themselves and their educational needs by trained professionals (instead of being guided by specific queries). even though this technique is the most time-consuming, it offers the most in-depth needs identification (younger et al. ) . these committees are formed by women employee representatives of specific at-risk populations, and consult whp professionals on specific issues related to reproductive health disorders among certain categories of workers, contributing their own experiences and concerns. the ecological model (mcleroy, bideau, steckler & glanz ) that was presented in the first chapter of this book offers the opportunity to identify the determinants of individual behavior within the wider context of social groups or organizations to which a person belongs. this perspective can therefore be useful for implementing comprehensive whp programs addressing specific health issues. analyzing the profile of a specific organization according to the five individual levels of the ecological perspective model-intrapersonal, interpersonal, institutional, community, and policy-one can identify multiple and multi-component potential interventions for the protection of female workers from the main categories of reproductive hazards recognized in the existing literature. at the intrapersonal level, workplace health promotion activities focus on individual skill building for female workers in the form of personal counseling on issues of reproductive health. the general scope of these interventions, some of which are presented in table . , is the introduction of a number of issues including: • identification of occupational reproductive hazards, personal risk factors, and related symptoms • requested behavioral changes towards prevention • skill-building in the correct use of equipment, materials, and safety practices • access to scientific resources and specialized health services workplace health promotion interventions at this level appeal to groups of working women instead of individuals. this stage of whp involves skill-building sessions, team collaboration and support activities, and health education, which may vary in group size or duration according to the educational needs of a specific working population. these groups can be selected according to common epidemiological or social characteristics of the workers (e.g., age, education, ethnicity) to adequately tailor any intervention. table . presents some of the group activities that may take place within the context of whp: cited in table . is a list of available interventions at the institutional (or company) level concerning organizational measures, practices, and policies that may be implemented for the protection of women worker's reproductive health. to implement effective workplace health promotion programs for the protection of female reproductive health, health professionals should not neglect the fact that the female working population in a specific worksite acquires certain characteristics that • group training sessions on radioactive material safe handling, and protective measures against ionizing radiation • group skill-building on stress management techniques, workplace design for the protection of pregnant women employees, safe manual handling methods • group education on infectious agents hazardous for female reproductive health, their transmission pathways, methods for prevention generic: • creation of employee's groups to constitute models of "best practice" and provide a supportive environment for the adoption of safety techniques (or "healthy behaviour") among women workers • creation of idea-exchanging groups, for identification of specific workplace reproductive hazards and special issues of concern for women workers define a community. the main focus of a successful whp project at this level is to incorporate the issue of reproductive health in the safety culture of female workers. this involves organizing targeted group activities for female workers that addresses the problem of reproductive hazard prevention through the community's system of "group norms, inner rules and beliefs" (edlich, winters, hudson, britt & long ) , and create a climate of awareness on issues related to female employees. at this level, workplace health promotion programs involve contacts with stakeholders (trade union members, employee representatives, company executives) and policymakers to propose measures, policies, and legal provisions for the protection of female workers' reproductive health, some of which are listed in table . . whp programs may utilize multiple channels of communication to deliver messages related to women's reproductive health protection. the approach may take various forms (prevention ): • proposals (by health professionals) for specific changes in the production line -substitution of chemical factors which are detrimental for female reproductive health with "safer" compounds • proposals for specific design changes in facilities, to isolate chemical procedures • frequent measurements by health technicians in the workplace to record concentration of chemicals, and identification of high risk population • training of occupational physicians and nurses in: a) identification of chemical reproductive hazards b) available preventive measures c) early diagnosis of reproductive disorders • re-positioning of pregnant employees to reduce potential exposure to chemicals • provision to all staff members of specific company's guidelines on occupational safety and reproductive hazards prevention (official forms, leaflets, electronic mail), as well as standard operating procedures for using chemicals • rotation of workers to reduce potential exposure • definition of a strict company's policy on health protection for non-smokers • placement of warning signs to prohibit smoking in the company • provision of adequate outdoor spaces, and timebreaks for smokers • funding of campaigns and incentives on smoking cessation for employees • proposals for specific design changes (e.g. armoring improvement, isolation of radioactive material) to avoid exposure of personnel to radiation • frequent radiation measurements in the workplace environment to identify potential sources of exposure and high risk employees • provision (to all staff) of specific directives on safe use of radiation emitting equipment (instruction sheets, official forms, leaflets, electronic mail) • re-positioning of pregnant employees to reduce potential exposure. rotation of workers to reduce potential exposure • proposals to administration to conduct adequate modifications in ergonomic design and provision of special equipment table . (continued) potential hazard intervention opportunities • proposals to administration for the introduction of specific safety regulations concerning female employees (especially during pregnancy): a) time-schedule modification, b) maximum working hours, c) mandatory time-breaks, d) provision of sick-leave days, e) maximum allowed weight for manual handling, f) re-positioning of pregnant employees, g) zero-tolerance policy on aggressive behavior against employees • providing staff with the organization's safety guidelines for preventing physical strain (instruction sheets, official forms, leaflets, electronic mail). rotation of workers to reduce physical strain • provision to all staff of educative material on potential effects of infectious agents to female reproductive health • introduction of collective safety guidelines for all health-care personnel • provision of adequate safety equipment to prevent accidental transmission of infectious agents (safety syringe mechanisms, syringe disposal vessels, goggles, masques, gloves) • extensive vaccination program for child-bearing age personnel (health care workers, teachers, nursery workers) lectures constitute single courses or one-shot education interventions (prevention ) providing general information on the topic of occupational reproductive hazards for women (risk factors, generic preventive measures). presentations and lectures may be used as well to carry health messages among the staff in an effort to establish general acceptance and support for the company's pertinent safety regulations and policies. (lawson et al., ) • systematic occupational exposure assessment to identify high risk female employees • proposal for legislative regulation to substitute hazardous agents with "safer" chemical compounds • promotion of scientific research on gender specific reproductive issues for female workers • obligatory reproductive health surveillance of women workers in high risk for reproductive disorders • systematic registry of birth defects according to maternal occupational exposures • production of specifically designed protective equipment for female workers this form of communication is able to provide wide-scale access to the population of working women (e.g., access to agricultural workers in distant areas, low-literacy skill employees) through billboards, magazines, and newspapers published by the company, or items of special interest to certain professional sectors, such as leaflets referring to reproductive safety issues. health professionals may utilize this channel to address generic guidelines for prevention on issues of reproductive health either to female workers themselves or to their coworkers, which may effect women employees through their tasks or behavior (e.g., men employees smoking indoors, safe storage or handling of hazardous chemicals in the workplace). this form of health promotion is based on establishing an interactive information service for the prevention of occupational reproductive disorders (prevention ) . this service should incorporate a telephone center with the ability to provide personal telephone counseling to women employees, as well as a hotline for answering women's questions concerning reproductive health issues. furthermore, this service should develop an electronic library, accessible through the internet, for all female workers and the general public, providing official safety guidelines for reproductive hazards and answers to related questions. finally, it enables continuous sensitization of high-risk female employees through frequent electronic reminders and their activation in safeguarding their reproductive health. media has proven to be one of the most effective communication channels for many health issues and health promotion activities. it can be utilized to address messages on a larger scale, mostly by health professionals who work in workplace health promotion programs on community, national, or european level. it uses public announcements, short messages, and commercials to address reproductive health hazard prevention issues through radio, television, and newspapers. in some cases, this form of health promotion may be useful for approaching female workers who are not easily accessible by other workplace health promotion programs, such as occupations in small enterprises, part-time employment, and female agricultural workers in remote areas. • violent behavior intense psychological stress (artazcoz lazcano, cruz i cubells, moncada i lluis, & sanchez miguel exposure to ionizing radiation (x-ray & computed tomography departments, nuclear laboratories, patients treated with radioactive drugs) anaesthetic gases, cytotoxic drugs • infectious diseases airborne, blood borne • dermatitis (allergic, irritative) • disturbance of the regular circadian -metabolic rhythm gimeno, felknor, burau, & delclos, ) and micro particles indoor air quality and health in offices and other non-industrial working environments prevalence and risk factors of occupational asthma among hairdressers in turkey incidence of asthma in female swedish hairdressers current findings about the development of obstructive airway diseases in hairdressers (bk numbers: / ) women's occupational dermatologic issues associations of self estimated workloads with musculoskeletal symptoms among hospital nurses combining job and family demands and being healthy: what are the differences between men and women? gender inequalities in health among workers: the relation with family demands stress and work-related tension in the nurses and clinical aides of a hospital predictors of early leaving from the cotton spinning mill environment in newly hired workers interdigital pilonidal sinus in a hairdresser self-assessed and directly measured occupational physical activities-influence of musculoskeletal complaints, age and gender evaluation of reports of periconceptual occupational exposure: maternal-assessed versus industrial hygienist-assessed exposure work-related obstructed airway diseases by irritative noxae in the low concentration range evaluation of occupational environment in two textile plants in northern india with specific reference to noise noise exposure of music teachers laundry workers: cleaning up an industry. we can do it: protecting women workers hazardous substances in the air at hairdressers' workplaces work-related musculoskeletal disorders in hairdressers the hazards of surgical smoke. not to be sniffed at! british journal of perioperative nursing : the journal of the neck and shoulder ailments in a group of female industrial workers with monotonous work ergonomic scissors for hairdressing heat exposure standards and women's work: equitable or debatable? women health cadmium induces mitogenic signaling in breast cancer cell by an eralpha-dependent mechanism a pharmacokinetic study of occupational and environmental benzene exposure with regard to gender occupational exposure to endocrine-disrupting pesticides and the potential for developing hormonal cancers occupational hazards of inhalational anaesthetics effects of long term exposure to occupational noise on textile industry workers' lung function dna damage and tnf(alpha) cytokine production in hairdressers with contact dermatitis risk evaluation and health surveillance in hospitals: a critical review and contributions regarding experience obtained at the s. gerardo dei tintori hospital in monza health care providers and professional hazards promoting personal safety of building service workers: issues and challenges. aaohn journal : official journal of the american association of occupational health nurses workstation design in carpet hand-weaving operation: guidelines for prevention of musculoskeletal disorders nurses confronting sexual harassment in the medical environment musculoskeletal disorders in hotel restaurant workers mortality among us employees of a large computer manufacturing company factors influencing restaurant worker perception of floor slipperiness handle with care: the american nurses association's campaign to address work-related musculoskeletal disorders prioritizing safe patient handling: the american nurses association's handle with care campaign epidemiology of voice problems in dutch teachers cross-sectional investigation of task demands and musculoskeletal discomfort among restaurant wait staff work-related violence and the ohs of home health care workers working in clients' homes: the impact on the mental health and well-being of visiting home care workers. home health care services quarterly health hazards of ceramic artists occupational contact urticaria and protein contact dermatitis are health care providers who work with cancer drugs at an increased risk for toxic events? a systematic review and meta-analysis of the literature prevalence of voice disorders in african american and european american preschoolers prevention of disabling back injuries in nurses by the use of mechanical patient lift systems gender issues in safety and health at work -a review. luxembourg: office for official publications of the european communities european agency for safety and health at work ( b) including gender issues in risk assessment [electronic version mainstreaming gender into occupational safety and health. luxembourg: office for official publications of the european communities eurostat ( ) european social statistics: labour force survey results : office for official publications of the european communities fjellman-wiklund a, brulin c, and sundelin g ( ) physical and psychosocial work-related risk factors associated with neck-shoulder discomfort in male and female music teachers prevalence of sensitivity to rubber additives and latex in hairdressers with hand and/or forearm contact dermatitis diagnostic approach and management of occupational asthma by persulfate salts in a hairdresser. allergy and asthma proceedings : the official journal of regional and state allergy societies sex differences in pharmacokinetics and pharmacodynamics pesticide exposure and women's health adequacy of vaccination coverage at school-entry: cross-sectional study in schoolchildren of an urban population pulmonary fibrosis and ferruginous bodies associated with exposure to synthetic fibers the precede-proceed planning model organisational and occupational risk factors associated with work related injuries among public hospital employees in costa rica bad nights or bad bars? multi-level analysis of environmental predictors of aggression in late-night large-capacity bars and clubs health promotion planning: an educational and environmental approach knowledge, attitude and practices among health care workers on needle-stick injuries high rubella seronegativity in daycare educators fit factors for quarter masks and facial size categories the risk of adverse reproductive and developmental disorders due to occupational pesticide exposure: an overview of current epidemiological evidence traumatic injuries in agriculture haz-map ( b) cadmium and compounds. occupational exposures to hazardous agents retrieved glycol-ethers. occupational exposure to hazardous agents occupational exposure to sevoflurane, halothane and nitrous oxide during paediatric anaesthesia. waste gas exposure during paediatric anaesthesia chemical exposure in hairdresser salons: effect of local exhaust ventilation gender differences in self-reported physical and psychosocial exposures in jobs with both female and male workers quantification and risk 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problems in teachers an analysis of occupational dysphonia diagnosed in the north-east of poland do teachers have more health problems? results from a french cross-sectional survey work practice and some adverse health effects in nurses handling antineoplastic drugs case report: occupationally related recurrent varicella (chickenpox) in a hospital nurse characterization of chemical exposures in hairdressing salons printed circuit board industry perceiving classroom aggression: the influence of setting, intervention style and group perceptions workgroup report: implementing a national occupational reproductive research agenda-decade one and beyond gender differences in the healthy worker effect among synthetic vitreous fiber workers voice symptoms of call-centre customer service advisers experienced during a work-day and effects of a short vocal training course respiratory illness in agricultural workers making manufacturing a safe work environment for women workers. we can do it: protecting women workers evaluation of the exposure to biomechanical overload of the upper limbs and clinical investigation in a female population employed in the manual loading of production lines in ceramics factories noise exposure and hearing loss in agriculture: a survey of farmers and farm workers in the southland region of new zealand an investigation of contact transmission of methicillin-resistant staphylococcus aureus women in agriculture: risks for occupational injury within the context of gendered role male and female rate differences in carpal tunnel syndrome injuries: personal attributes or job tasks? the "gras" status of women's work sex matters: exploring differences in responses to exposures an ecological perspective of health promotion programs workplace violence in health care: recognized but not regulated sex, gender and women's occupational health:the importance of considering mechanism ovarian intrafollicular processes as a target for cigarette smoke components and selected environmental reproductive disruptors the effect of health education in promoting health of hairdressers about hepatitis b based on health belief model: a field trial in yazd carpal tunnel syndrome and ulnar neuropathy at the elbow in floor cleaners occupational asthma among hairdressers occupational asthma and occupational rhinitis in hairdressers energy cost of physical task performance in men and women wearing personal protective clothing rubella infections of the school teachers in sapporo municipal schools after their employment adapting osha ergonomic guidelines to the rehabilitation setting theory at a glance: a guide for health promotion practice theory at a glance" a guide for health promotion practice how is sex considered in recent epidemiological publications on occupational risks? muscle pain, physical activity, self-efficacy and relaxation ability in adolescents gender inequalities in occupational health: harvard school of public health accidental exposure to 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- exposure to cooking fumes in restaurant kitchens in norway effects of glutaraldehyde exposure on human health occupational risk factors associated with voice disorders among teachers health risks of occupational exposure to anticancer (antineoplastic) drugs in health care workers assessment of dna damage in nurses handling antineoplastic drugs by the alkaline comet assay assessment of dna damage in nurses handling antineoplastic drugs by the alkaline comet assay visual problems among electronic and jewelry workers in thailand association between occupational asthenopia and psycho-physiological indicators of visual strain in workers using video display terminals please put this in the proper format and move this reference to its alphabetical place in the "p's" weaver vm secondary individual prevention of occupational skin diseases in health care workers, cleaners and kitchen employees: aims, experiences and descriptive results. int arch occup environ health williams nr ( ) occupational groups at risk of voice disorders: a review of the literature chemical occupational risks identified by nurses in a hospital environment work-related musculoskeletal disorders and associated factors in teachers of physically and intellectually disabled pupils: a self-administered questionnaire study seroprevalence of varicella, measles and hepatitis b among female health care workers of childbearing age immunization and child health materials development guide zidkova z and martinkova j ( ) psychic load in teachers of elementary schools key: cord- -b kubfl authors: milcent, carine title: hospital institutional context and funding date: - - journal: healthcare reform in china doi: . / - - - - _ sha: doc_id: cord_uid: b kubfl this chapter focuses on hospital ownership and supervision. public hospitals are mostly, but not always, under the supervision of the health ministry. there are a certain number of other governing bodies that are directly involved in the management of hospitals. a cross-ministry group was set up in to facilitate the implementation of hospital reforms. apart from the organizational structure, the funding of hospitals and its evolution is studied. between and , the government introduced a co-payment system in healthcare establishments. in , the ministry of health officially granted greater autonomy to public hospitals. they were authorized to deliver paid services and to make profits, but were made responsible for their losses and debts. by , central government funding had fallen to % of the hospital budget. as a result, public hospitals in china behave very similarly to for-profit firms, while being governed as any traditional public structure. the next step is the current experiment of a diagnostics related group-based payment in china. along with the financial autonomy of public hospitals, different reforms have been directed at developing private hospitals, even though many obstacles still remain. in this chapter, we separate the hospital by ownership (public/private) for discussion. because of the historical healthcare system context, the public sector is more mature than the private one. as a consequence, some pilot reforms are introduced only in the public sector. as example is the implementation of a diagnostics related group-(drg)-based payment presented at the end of the first section of this chapter. actually, this does not mean that the private sector will be immune to these new forms of funding. in the united states, for instance, when the drg-based payment was introduced, it was designed for medicare patient (patients aged over ) without focusing on a specific hospital ownership by also targeting private hospitals. ownership after the implementation of the "three-tier public provision system", most hospitals were under the direct supervision of the health ministry, with support from local health offices. nevertheless, some remained dependent on state-owned companies or the army. other governing bodies were involved in maternity and family planning centres, at county and township level. whatever the governing body, the healthcare supply was provided by the public sector. today, health centres in both rural and urban areas are split between public and private structures. in rural zones, community clinics are mostly private whereas urban county hospitals remain mostly public. comparing figs. . and . illustrates that the healthcare supply shift from the public sector to the private sector is an ongoing process. public hospitals are mainly but not solely under the supervision of the health ministry. there is still a certain number of governing bodies, ministries or state-owned companies that are directly involved in the management of hospitals. for instance, the people's liberation army (pla) and some large state-owned industries, such as the railways, have their own hospitals and medical schools. most hospitals and medical schools affiliated with the pla are considered to be of a high quality and provide services to political leaders. that have not yet been classified. the "non-profit" category mainly consists of organizations owned by government and companies (available data do not permit a disaggregation of the non-profit category by ownership) this fragmented structure is a hurdle to the implementation of any hospital reform, with four main ministries involved: the national development and reform commission (ndrc), the ministry of human resources and social security (mohrss), the ministry of finance (mof) and obviously the ministry of health (moh). these ministries do not have the same objectives. as a consequence, healthcare suppliers do not respond to the same incentives, which leads to a lack of co-ordination between healthcare providers. the effect of the reforms implemented may be affected by this multiplicity of governing bodies. the sars epidemics in has crystallized the importance of public health and care. many experts and officials have pointed out the flaws in the health system that led to the quick spread of the sars virus. as a consequence, a think tank was created to give strategic direction to future reforms: the development research centre (drc) reports to the chinese state council. one of its reports heavily influenced the reform package. to solve the complexity of implementing chinese health system reforms, a cross-ministry group was set up in to facilitate the implementation of hospital reform. this leading group for coordination healthcare system reform is dependent on the ndrc and health ministry and its first chairman was the future prime minister li keqiang. in , this group in the state council was restructured with the mission to co-ordinate all stakeholders of healthcare reform, from provincial governments to ministries involved and administrations in charge of implementing reforms. it made various and important policy initiatives at the central level. this leading group consists of representatives from ministries including the moh, mohrss, mof and ndrc. as a support, one agency from each of the four main ministries is in charge of a specific part of the reform. resources from other governing bodies are also tapped for more specialized aspects (see table . ). besides which, every province set up a local team for health reform. they are in charge of a specific checklist of tasks from the state council that can be completed by the provincial authority. as a consequence, all reforms implemented since are not coordinated by the ministry of health but by a special unit reporting directing to the state council (or more precisely to the health reform office of the state council). yet, this unit does not have the ability to actually implement the decisions taken. it needs to go the ministries to execute decisions. in reality, these reforms involve a large numbers of governing bodies. the national development and reform commission (ndrc) and the ministry of finance (mof) in particular have a key role. the different ministries involved can sometimes have conflicting priorities. for instance, if we take the example of health insurance, mohrss is in charge of insurance in urban areas, whereas the ministry of civil affairs (moca) manages a programme for the underprivileged that includes insurance covering basic care. in parallel, the china insurance regulatory commission (circ) has a mission to encourage the development of a private health insurance market. another example is any reform touching hospital human resources. the office of central institutional organization, the ministry of education as well as mohrss, because it manages the career of civil servants, are necessarily involved. daily governance is also complex. for instance, for investment decisions for public hospitals, two ministries share responsibility: the moh and the national development and reform commission (ndrc). as a result, public hospitals may receive conflicting policies and regulations. in addition, for the execution of policies, many other bodies are involved: authorities at provincial level, district level and city level, bureaus of labour and social security, health and finance. this huge number of stakeholders shows the complexity of hospital reform in china. if the central government defines the general direction and objectives, this actual implementation takes place under steering at a more granular level-provincial and below. this, combined with a large financial autonomy, makes it possible to factor in local specificities in the actual execution of reforms but can also generate important territorial inequalities. a costly reform implemented in an area hit by economic downturn will not produce the same effect as when implemented in a soaring region. to mitigate this risk, each authority in charge of implementation at the local level is given measurable targets, for instance, the number of people covered by public health insurance at a certain date. these targets are cascaded into the individual objectives of local political leaders, having a direct impact on their career advancement and promotion into the party's apparatus. nonetheless, many health reform objectives are not easily quantifiable, for instance better governance, leaving widespread nuances in interpretation. at the beginning of the s, the central government was paying for % of hospital expenditure. over the - period, the government introduced a co-payment system in healthcare establishments. the aim was to provide greater flexibility in terms of profit, and thus to incite establishments to improve the quality of the services they offered and professionalize their medical staff ). in , the ministry of health officially granted greater autonomy to public hospitals, through an official document published in september by the state council, "instructions on health reform". by this, public hospitals were authorized to deliver paid services and to make profits, but were made responsible for their losses and debts. they have to self-finance their investment in equipment and infrastructure as well as a salary bonus policy. they are also entitled to enter into joint ventures with private companies, including setting up for-profit departments within the public hospital itself. as a result of this reform, bigger hospital structures developed, as well as improved quality, thanks to the acquisition of high-tech equipment. since then, public hospitals in china have the particularity that they behave as companies, aiming to maximize profit through investment and price setting, while being governed as any traditional public structure. they are the sole recipient of public funding, be it from the central or local governments. staff management is under the supervision of central governing bodies, mainly the morhss, from both a resource allocation perspective as well as individual career management. while they keep this strong bond with central authorities, they have financial autonomy. they are able to determine their price policy, which can turn out to be a problem in cases where they are in a monopoly situation in certain geographical areas, and hence without the market regulation of pricing. by central government funding had fallen to % of hospital expenditure. the fall in state financing was offset by charging for medicines and diagnosis procedures. in china, as in many other asian countries, patients do not consult doctors in their doctor's office-outside any healthcare facilities-but in the hospital outpatient department. prescriptions are given at the end of the consultation by default (patients are not asked if they want to purchase them). the total cost is the sum of the price of the consultation and that of the prescribed medicine. patients do not have an explicit choice in not accepting the doctor's prescription. in this context, prescription prices can be varied in order to compensate for the fall in the hospital's central funding. this practice has been severely questioned during the recent healthcare reforms in china. prescriptions currently account for about half of healthcare expenditure. the overprescription of medicine and the over-use of high-tech equipment for diagnostic purposes have often been identified as the cause of the rapid increase in healthcare expenditure (eggleston et al., a ; . the current healthcare system has been judged to be both too costly and more sophisticated than is medically necessary (world bank, ; blumenthal and hsiao, ). it is very likely that these factors affect the demand for and use of healthcare. following the -reform, some public facilities set up healthcare centres with a fee-for-service payment. as expected, these for-profit firms reoriented their activity to the most profitable healthcare areas. these forprofit health centres did not have to provide any public-service mission. the healthcare prevention programme was then neglected: epidemic control, health education, maternal and child health all suffered. the sars epidemic put the public health role of public hospitals to the forefront again. the negative side-effects of financial autonomy appeared sharply in that context. this led to a clear split between medical operations and hospital management functions. additionally, it was demanded that for-profit activities be clearly split from the rest in hospital books of account. nonetheless, in , health expenditure for pharmaceutical products still accounted for % of total health expenditure. this compares with a % average share in organisation for economic co-operation and development (oecd) countries. per capita medicine expenditure reach rmb . nearly million surgeries were performed in china in . this figure is nearly one-sixth of the world's total surgical operations. the biggest share of procedures is in the obstetrical and gynecological areas, followed by digestive and gastrointestinal system procedures. according to yip and hsiao ( ) , "from to , personal health spending per capita increased by a multiple of from rmb to rmb (or from roughly to usd) while the consumer price index increased by . times during this period. a huge portion of this expenditure was for high-tech tests and unnecessary drugs." , in the s, the main objective of the regulator was to make it possible for hospitals to acquire technology and to improve their level of quality. in parallel, the aim was also to reduce the burden of hospital expenditure funding. the series of reforms implied three main changes: • financial autonomy of public hospitals • managerial autonomy for a part of public hospital staff • financial incentives for physicians to profit. financial autonomy of public hospitals: this has been achieved at the expense of accessibility for many. the share of health expenditure in total income has rocketed during the past years. in , per capital health expenditure in urban areas was still contained at a very low level of rmb , whereas it reached more than rmb , in . another effect of the financial autonomy of public hospital has been a certain loss of authorities over medical practices. managerial autonomy: in parallel, hospitals have autonomy in personnel management for their for-profit activity. for that part of the activity, personnel are not under the same governance and control by authorities. this co-existence is bound to create tensions, as salary differences appear between the official public salary scale and unregulated salaries of the forprofit activities. additional benefits can be granted to physicians and other medical personnel, based on a very non-transparent basis, leading to many frustrations. pursuit of profit can become the top priority while it was totally disregarded in previous situations. the objective function of medical personnel includes an increasing component of profit maximization. financial incentives for physicians: in public hospitals, physicians are civil servants (bianzhi) . this status implies certain benefits that will be described later and ensures a fixed income, independent from their volume of activity. yet, this fixed income is often described as being fairly low in view of both their responsibilities and other revenue sources. an additional income source has been authorized dependent on the for-profit activity of the hospital. one can then easily see that physicians have an incentive to develop the for-profit activities, for instance increasing the number of consultations, delivering over-diagnoses or over-prescribing. in such cases, it is a win-win situation for both medical personnel and hospital management. in addition, this healthcare system nurtures the pre-existing practices of bribes and other types of corruption. they tend to become widespread, creating an increasingly tense atmosphere between patients and hospital personnel. the chinese healthcare system has long been accused of failing to efficiently deliver healthcare services at an affordable cost. in , a set of reforms were implemented, giving the state a bigger role in the production and distribution of health services. nonetheless, public hospitals receive only limited funding from the regulator. figure . shows the different sources of funding. it is quite striking that direct public funding from the government only represents a minimal share of the total ( %). in reality, the involvement is more pronounced with indirect funding through public health insurance set up in both rural and urban areas. companies also participate in the financing of healthcare, accounting for almost one-third of the total. patients' share accounts for % of hospital revenue, but patients usually do not bear the total costs, as part is covered by public or private health insurance. the covered part has been increasing steadily over the past few years. in the end, patients' out-of-pocket payments rose from % in to % in , but then decreased to a current rate of around %). , a landscape analysis of the health insurance market in china is presented in chap. . some experiments, presented here, aimed at switching from a fee-forservice payment to any form of prospective payment. the goal is to modify incentives for healthcare providers: from driving up service prices to introducing and encouraging competition with a price ceiling system. in urban areas, the insurance schemes existing before the economic reform were based on a principle of regulated pricing. when the basic medical "other" includes private health insurance (both supplementary and stand-alone); employer contribution to group private health insurance, which is around $ million. total funding is around $ million. source: hospital interviews; government statistics , "healthcare in china," a kieger report on the chinese healthcare market . www.mckinsey.com/...service/healthcare% systems% and% services/health% international/hi _china_healthcare_reform.ashx insurance (bmi) scheme was introduced, a mechanism to contain expenditure from the demand side was implemented (the medical savings accounts-msa). on the supply side, there was no change in the provider payment introduced by central government. however, at local government level, examples of the implementation of some form of prospective payment can found from the early bmi pilot. in , the social insurance bureau of hainan province implemented a prospective payment, concerning six key hospitals. this payment was quite similar to a global budget system. studies led by eggleston ( and , show that average expenditure by admission fell below that of other hospitals on a fee-for-service basis. besides, spending growth on expensive drugs and high-tech services was reduced dramatically. the defined limits of these studies concerns the fact that the data were not available to control for the potential reduction of quality of care, risk selection and cost shifting to the uninsured. implementation of similar forms of prospective payment systems were nonetheless implemented in many areas throughout china, as in qingdao, shandong province, for instance. some other cities introduced payment per capita as an alternative prospective payment form. in , jiujiang city switched to capitation: a fixed amount per capita (contrary to per inpatient or per inpatient day as presented so far) on a defined geographic area. medical expenditure per insured inpatient fell dramatically and the share of drug expenditure in total spending fell drastically. however, lack of information about the impact on the healthcare level of quality prevents any conclusion being drawn. the diagnosis related group (drg) payment is a reimbursement scheme that was first implemented in the united states at the beginning of the s. this type of payment is a form of prospective payment system and consists of a lump sum based on the pathology and procedures to be carried out on the patient. a categorization of pathologies, diagnoses and actions is made ex-ante. all patients are affected in one these categories, collectively called the diagnosis related group (drg). each drg defines a pathology, associated diagnoses and all procedures already implemented or yet to be implemented. this way, each patient falls into a drg and each drg corresponds to a predefined lump sum, based on the expenses the hospital has to incur to carry out treatment for this type of patient. the advantage of this lump sum is that it is not correlated with the treatment actually performed while covering the theoretical expenses necessary to cure the patient. this gives an incentive to limit cost, explaining why this type of payment is widespread, not only in china but in a vast majority of oecd countries. the efficiency of such a system relies heavily on the quality of the information system that goes with it. it is quite complex, as, for each patient, information regarding diagnoses, procedures and comorbidities is to be collected and compiled. china aims at putting in place a comprehensive information system with medical history and patient admission details. this project is still in the early stages though. zhenjiang, a bmi pilot city, started to experiment with a drg payment system for diseases. the reimbursement rate for each disease was set according to average expenditure incurred over the previous three years in treating each disease, minus any "unreasonable" expenditure. in , the average spending for diseases using the drg payment was % lower than the province average in hospitals of the same level. once again, because of the poor quality of data at the micro-level, studies on the impact of the drg payment system on the quality of care and risk of selection impact have unfortunately not been published yet. after that, drg-based payment systems spread across china, for instance, in cities such as guangzhou, dalian, liushou and mudanjiang. in guangdong province, as early as , a total of out of municipalities were already using such systems. however, this drg-based payment is still restricted to specific diseases. besides, these cities also use different prospective payment systems alongside a fixed charge per inpatient. studies on this aspect provided less strong evidence for drg-based payments or other forms of prospective payment on a reduction of healthcare spending. , , following the bmi offices' example, some local offices of ncms (public health insurance for inhabitants in rural areas) adopted a prospective payment system to reimburse the health providers. for instance, two counties in shaanxi province adopted a fixed-price reimbursement system for some selected thcs and selected county hospitals according to specific criteria. some providers moved from a ffs service to a prospective payment system but not in conjunction with a public insurance scheme. in heilongjiang province, by the end of , hospitals started to use a drg-based payment system. one goal was to attract private investment and more business by developing a reputation for transparency in pricing. , so far, there is no scientific study paper on the effect on quality of care or strong evidence on healthcare expenditure. to date, there are two main viable drg systems, the beijing-drg ( ) and the c-drg system set up by the nhfpc ( ). because of inconclusive results, in , these different forms of prospective payment are still being studied and this is an on-going field of research. we use here "private" in a wider sense, to cover all hospital structures apart from the public ones (minying), be it through joint ventures, cooperatives or private structures with capital from mainly hong-kong, macao, taiwan but also all over the world. until , it was legally impossible to set up a private hospital. different reforms since then have been directed at developing them, along with the financial autonomy of public hospitals. as of , . % of hospitals were registered as private structures, most of them being specialized establishments. nonetheless, the average size of private hospitals is much smaller than public hospitals. in , the average number of inpatient beds for a private hospital was , which is in sharp contrast to the average number of beds for a public hospital. recently, when classifying hospitals by their ownership, % of the hospitals in china are public, including state-owned and indirectly stateowned ones; the remaining % are private. in terms of level, according to the official hospital classification, the percentage of publicly owned hospitals by admissions is % for level and % for level hospitals. as a result, % of chinese patients choose to visit public hospitals. private hospitals in china only account for around % of the service volume and for % of beds while being operated at a lower level (fig. . ) . the picture is quite the opposite in the united states, where public hospitals make up % of total hospitals and only % of patient visits. nonetheless, the private hospital sector has been steadily increasing over the past few years. in , the share of beds in private hospitals reached . %, . % up from the previous year. the number of public hospitals grew from roughly in to , in . from to , the number of patients treated in a private hospital grew by . %. we can then observe a constant increasing trend but no sharp change (fig. . ) . in rural zones though, the situation is totally different. a large part of primary care is carried out in dispensaries that are now almost exclusively private and paid for on a fee-for-service mode. yet, it is quite difficult to precisely measure the actual progression of the activity of private healthcare establishments. until very recently, the information on the public or private status of a hospital was not made available in official statistics. in conclusion, the number of private healthcare facilities is increasing but, in terms of number of visits, there is no private hospital boom. the ministry of health has stated on various occasion that it wants to develop the private health sector. the objective set by the state council is for it to command % of the market by . why such support? as previously explained, public hospitals are largely in a monopoly situation in their geographical area. the decrease in public funding has led to a deregulation of healthcare pricing. the partially stated goal here is to increase competition between public and private hospitals to help regulate pricing. this is very similar to the mechanism in place in the united states for a large part of the population. using competition between public and private sectors to better regulate hospital care is also increasingly popular in a number of european countries (e.g. germany, the united kingdom, the netherlands and france). in china, the th five year plan ( - ) and the th five year plan ( - ) emphasize the development of private hospitals. until then, setting up a private healthcare structure had been legally possible for two decades, but almost impossible in practice, in particular due to the difficulties of hiring medically qualified personnel. private hospitals have been addressing, as a priority, three markets segments: high-end healthcare for expats and the affluent local population, healthcare targeted to very specific pathologies and finally healthcare in direct competition with that offered by public hospitals. the first segment enjoys sold growth. initially directed at expat consumers, it turns out to be increasingly used by high-end consumers. "half of our outpatients are expats working or living in china, such as diplomats and executives of foreign-invested companies. and the other half is high-income chinese residents. we sell by word of mouth," said zhu ying, president of the beijing bayley & jackson medical centre in downtown beijing, a private hospital with headquarters in hong kong. this is an example of what can be observed in very big cities in china. however, so far, this phenomenon is too new to draw an conclusion apart from this initial assessment. in the third segment, that of private hospitals in competition with public structures, the former sometimes have to face distorted competition, through public subventions. however, they also have to overcome the difficulties of attracting the best practitioners and resistance from the public towards a new structure with neither a track record nor endorsement from the community. this difficulty in attracting patients seems hard to understand in the context of dissatisfaction over the service provided by public hospitals, but it actually sheds light on the priority criteria of patients/customers. the quality and reliability offered by public hospital, through their high level of equipment and skilled and trained personnel, prevails over the annoyance of congestion and the price of care. as mentioned previously, recruitment of highly skilled professionals is one of the main obstacles to the development of private hospitals. the status of physicians in public hospitals, the benefits it brings and the additional wages received in various forms are often roadblocks to a migration to a private structure. a mckinsey report entitled "china healthcare reform" gives the example of beijing municipality. it addresses community healthcare centres (chcs) but the configuration is identical for private hospitals: "a few cities have tried to force more patients to go to chcs, but these efforts have generally been unsuccessful. in january , for example, one local government implemented a policy of requiring patients with certain chronic diseases to be treated at a chc before they could receive care at a class iii hospital. however, the local department of health withdrew this policy one month later, saying that the quality of the chcs needed to be improved before the policy could be implemented." the status and financial obstacles to hiring well-known professionals in private hospitals creates a vicious circle. as they do not manage to hire renowned physicians, private hospitals are obliged to hire young doctors with little experience. for both patients and professionals, this type of structure tends to become a second choice, when public hospitals are not an option. the story of an hua and li peng provides a good example. they are reputed physicians in a level hospital in beijing. they confided that working in a private structure could resolve their current, difficult, working conditions. where they work, they have to deal with an extended number of working hours, an excessive number of patients and a patienthospital staff antagonistic climate. however, according to them, the size of private facilities is too small to attract a sufficient number of patients; the healthcare equipment is too limited; and the professional environment does not provide a sufficiently stimulating setting in which to work and grow. this difficulty in recruitment is a recurring theme mentioned by professionals as well as academics. dr. wang zhen, from the chinese academy of social sciences (cass) gives the example of the creation of a private hospital in shenzhen in . it was a showcase collaboration between hong kong university (hku) and the shenzhen municipality. in , this state of the art facility has not managed to fill all the physician positions. out of full-time positions, are yet to be filled, to a point where it is seriously considering shift the establishment to a public status to solve the recruitment issue. in parallel, another obstacle to the development of private hospitals is the restrictive conditions on the reimbursement of healthcare expenses by public insurance. this does not include the reimbursement of healthcare in private facilities. however, a main part of the population can only afford to get healthcare access using public insurance. as a consequence, the restrictive rule of public insurance excludes a large part of the population from access to private facilities. recently, in some cases and in some areas, expenses in private facilities have been partially reimbursed by public health insurance. it would be interesting to assess the effect of such a change on the individual's preference in the choice of healthcare providers. so far, if some reforms have tended to develop the private health sector, there are still some keys determinants that limit this central state support. yu ying, a former physician in a famous beijing hospital, the peking union medical college hospital, is a key figure and spokesperson for public hospital doctors. her weibo blog (chinese equivalent of twitter) has more than million followers. on it, she has been describing her hesitation about leaving the public sector, her difficulties after crossing the bridge, but also the fulfillment it created for her. yu ying, who had chosen "emergency room superwoman" for her pseudoname, is one of the few professionals to have left a level hospital to create a private medical centre. when she decided to leave her public hospital, her objective was to open her clinic in beijing city, within the fifth ring road. however, as she explained, this was not as easy as expected. a series of administrative constraints and barriers prevented her from opening a centre there. all her efforts failed. having resigned from her previous hospital and given up her civil servant status, returning to the public sector was no longer an option. she decided to take her chance in chengdu, sichuan province, where she tried again to open a private clinic providing the most basic medical services. she failed again. during this time, she used her weibo blog to explain part of her difficulties and the obstacles encountered along the way. when i interviewed her, the term "bribery" was never mentioned. as she said, she was able to explain her disappointment without going too far into detail about the local administrative process. in march , she used her weibo account to explicitly address the authorities about her situation asking, "which deputy of the national people's congress can tell me why it is so difficult for a doctor, who has worked in the country's top-grade hospital for years and has held a doctorate degree after eight years of professional medical education, to open a regular clinic through formal channels?" the timing was perfect. it was between the plenary session of the national people's congress and the chinese people's political consultative conference, allowing a strong echo to her protest. the outcome was finally positive, even though she had to drop the idea of setting up her own facility. she is now the ceo of a private general clinic in beijing city run by the amcare group, a public-private partnership joint venture, two and a half years after having resigned from a top public hospital. despite her million fans, she has to struggle to both promote the quality of a market-oriented institution and recruit staff members from big public hospitals. her experience illustrates the difficulty faced by medical professionals in opening their own private health centres compared to the situation in most oecd countries. new series of policies since , a new series of policies have been released. the goal of these policies is to lower the barrier to entry for private health establishments. this should create a more adequate business environment and improve the share of private health structures in the healthcare market. in , a notification on "further encouraging and leading social capital to participate in healthcare institutions" was published. this document promotes and encourages social capital to run private hospitals. it covers more practical, detailed information on beneficial policies for running a private health structure. in order to facilitate the development of the private hospital sector, it also allows a lowering of the entry barriers for private medical institutes with foreign capital. as a pilot experiment, some local governments have lifter some constraints on public hospitals: for instance, experimenting with the privatization of public hospitals. currently, the private healthcare market has developed a model based on chains of private specialized hospitals. more specifically, the medical services provided by the private sector are mostly for dental treatment, ophthalmology and plastic surgery, as well as diagnosis labs and centres. these sectors are medical sectors where customized services may generate higher margins. maternity is also considered as a potentially profitable sector. for instance, by may , amcare had assisted in more than , births and its total revenue soared % to million yuan ($ million). in , us-based warburg pincus llc invested $ million in beijingbased amcare women's and children's hospital to support its expansion. today amcare accounts for about half of the high-end healthcare market for women and children in beijing, which is now dominated by private hospitals. according to the roland berger report illustrated in fig . , "investors with various backgrounds are entering china's private hospital market. foreign hospital chain investors, such as chindex have built up high-end chain hospitals in smaller size in china. local financial investors, real estate companies and pharmaceutical companies are mostly targeting at mid-end market and specialty hospitals. pharmaceutical companies such as shanghai fosun pharmaceutical group aim at broadening their value chain and boost selling of their own drugs by establishing hospitals or participating in public hospital privatization". a cluster of private medical companies and hospitals owned by people from the city of putian, commonly known as the "putian clan" (putian ji), also constitutes great power in the healthcare industry as over % of private medical companies in china are affiliated with the putian clan. the members of the putian clan have organized themselves into a chamber of commerce named "putian (chinese) health industry association" (putian (zhongguo) jiankang chanye zong shanghui) since . another part of the reform aimed at developing private hospitals is their inclusion into public health insurance schemes. until recently, a patient admitted into a private hospital was not eligible for reimbursement from public insurance. this constraint is progressively eased, in one province after the other. rules tend to vary depending on the area, but there is an increasing number of cases for which care provided in private healthcare centres can be covered by public insurance schemes. in addition, in some provinces or municipalities, private hospitals can be directly subsidized. again, it is important to note the decentralized structure of the chinese healthcare system. general direction and target is given by the central government but provinces have wide autonomy in actual implementation. in august , the national health and family planning commission jointly announced with the ministry of commerce that fully foreign-owned private hospitals were allowed in seven provinces (beijing, tianjin, shanghai, jiangsu, guangdong, hainan and fujian). , in future, key factors private health structures need to develop are: ( ) patient recognition that private health establishments can be as trustworthy this point ( ) is a prerequisite condition. the development of the private sector is based on a high level of healthcare quality. the over-arching goal of profit maximization must not contaminate the level of quality provided. in , press articles drew attention to private healthcare companies that severely undermined doctors' medical professionalism. as witnesses, doctors previously employed by putian clan hospitals, stated that to achieve profit targets set by their superiors they performed unnecessary medical treatments. they added that these practices are not uncommon in these hospitals as doctors are directly employed by the hospitals they serve. a necessary challenge will be to make a profit without undermining the level of quality provided. even at a slower pace than anticipated, things are starting to change and the private sector is now showing significant growth. according to the nhfpc, from september to september , the number of private hospitals has increased by , while the cohort of public hospitals was reduced by . from through , patient visits to private hospitals have increased by . % from third trimester to third trimester , overstepping the growth of visits to public hospitals, which have grown at . % on a quarter-to-quarter basis. in fact, since the economic reforms of the s, there have been two schools of thought regarding the direction the health system in china should take. one is a pro-market group that advocates market liberalism to improve the quality of healthcare and efficiency. the other is a progovernment group that advocates the need for a large government role in the production and distribution of health services. the latter prioritize issues of equity or fairness and aim at reducing social inequities. depending on the period, each school of thought has had the upper hand in the direction given to reform. the last round of reform since is very much market-oriented, the market being expected to play a decisive role in the allocation of resources. the third plenum of the th central committee of the communist party, in november , emphasized a higher priority for economic growth. therefore, the conditions required for the development of the private sector in the healthcare market are fully in place with favourable policies. in a near future, with this preferential environment and the ongoing governmental commitment, a rapid growth of the private sector is to be expected. this evolution should have, at least, two consequences. one could be to put pressure on public hospitals and push them to keep going at improving their level of quality, not only in terms of medical services but also in the overall service quality (including accommodation, catering, etc.) and operational efficiency. the other consequence could be to limit the demand for public hospital access (for in-and outpatients) and reduce congestion in the level and aaa public hospitals. these forecasts on the effect of a more prominent presence of private healthcare providers in the healthcare market are based on a major assumption: that the income or wealth of a society is equitably distributed. the hypothesis is very strong and very restrictive. with increasing income inequality, the part of the population who cannot afford to access to healthcare will increase. an adequate and efficient alternative may be universal healthcare access for all. while this may be too costly for society it may avoid the failure of the market in providing equal access to healthcare. the healthy china project includes universal healthcare access by the year for basic healthcare supplies. besides the success of this programme, the central question will be "what is included in the 'basic healthcare supplies' basket?" notes health care systems in transition: people's republic of china. part i: an overview of china's health care system china's health system: from crisis to opportunity chinese health care reform: problems, reasons and solutions health service delivery in china: a literature review economic reforms and health insurance in china state council of prc, opinions on further reforming of health care systems health service delivery in china: a literature review impacts of medicine price on new cooperative medical scheme taking stock of china's rural health challenge privatization and its discontents: the evolving chinese health care system what drove the cycles of chinese health system reforms? report of china national health accounts, beijing: china health economics institute early appraisal of china's huge and complex health-care reforms million-surgeries-performed-china-last-year inappropriate tuberculosis treatment regimens in chinese tuberculosis hospitals we will see later that bianzhi status is very specific reform of how health care is paid for in china: challenges and opportunities success factors for women's and children's health study groups provider payment reform in china: the case of hospital reimbursement in hainan province addressing government and market failures with payment incentives: hospital reimbursement reform in hainan, china the authors used a difference-in-difference econometric method using data from payment arrangements for contract hospitals jiujiang health insurance office, the ' ' urban health insurance arrangement the impact of provider payment reforms on cost containment drg-based payment reform for urban health insurance scheme the impact of urban health insurance reform on hospital charges: a case study from two cities in china reform of medical insurance system in chinese cities: discussion on equity of cost allocation drg-based payment reform for urban health insurance scheme world bank mission team about drg payment reforms review of provider organization reforms in china the growth of private hospitals and their health workforce in china: a comparison with public hospitals china healthcare: where to position for growth investment injection see paragraph on bianzhi status chc is a healthcare facility providing care for outpatients when expenses incurred in private facilities are reimbursed by public health insurance, the reimbursement rates are lower than those for public facilities yu ying: china's 'face of er' who runs new beijing hospital amcare corporation operated seven medical facilities for women and children in china the prc government's no. document ( . . ): notification on further encouraging and leading social capital to participate in healthcare institutions entering china's private hospital segment putian ji: youyi zhong cheng wangguo-zhongguo de minying yiyuan bacheng du shi tamen de" (putian clan: wandering doctors become a kingdom-eighty percent of private hospitals in china belongs to them restrictions loosened on overseas ownership of hospitals, china daily they are forcing us to be immoral: putian-clan doctors revealed how hospitals make money), southern weekly the argument about the new health reform lines: government and market about drg payment reforms privatization and its discontents: the evolving chinese health care system economic reforms and health insurance in china health service delivery in china: a literature review health service delivery in china: a literature review chinese health care reform: problems, reasons and solutions inappropriate tuberculosis treatment regimens in chinese tuberculosis hospitals health care systems in transition: people's republic of china. part i: an overview of china's health care system reform of how health care is paid for in china: challenges and opportunities they are forcing us to be immoral: putian-clan doctors revealed how hospitals make money), southern weekly china healthcare: where to position for growth jiujiang health insurance office, the ' ' urban health insurance arrangement success factors for women's and children's health study groups reform of medical insurance system in chinese cities: discussion on equity of cost allocation the impact of provider payment reforms on cost containment review of provider organization reforms in china the impact of urban health insurance reform on hospital charges: a case study from two cities in china investment injection payment arrangements for contract hospitals the growth of private hospitals and their health workforce in china: a comparison with public hospitals china's health system: from crisis to opportunity impacts of medicine price on new cooperative medical scheme taking stock of china's rural health challenge yu ying: china's 'face of er' who runs new beijing hospital drg-based payment reform for urban health insurance scheme addressing government and market failures with payment incentives: hospital reimbursement reform in hainan, china provider payment reform in china: the case of hospital reimbursement in hainan province what drove the cycles of chinese health system reforms? early appraisal of china's huge and complex health-care reforms the argument about the new health reform lines: government and market key: cord- -xofwk a authors: davis, mark title: uncertainty and immunity in public communications on pandemics date: - - journal: pandemics, publics, and politics doi: . / - - - - _ sha: doc_id: cord_uid: xofwk a this chapter examines uncertainty in the expert advice on pandemics given to members of the general public. the chapter draws on research conducted in australia and scotland on public engagements with the influenza (swine flu) pandemic and discusses implications for communications on more recent infectious disease outbreaks, including ebola and zika. it shows how public health messages aim to achieve a workable balance of warning and reassurance and deflect problems of trust in experts and science. the chapter considers how uncertainties which prevail in pandemics reinforce the personalization of responses to pandemic risk, in ways that undermine the cooperation and collective action which are also needed to respond effectively to pandemics. uncertainty is a central challenge for public communications on matters pandemic. recent efforts to respond to outbreaks of infectious diseases, such as pandemic (swine flu) influenza (world health organization ), ebola (green ; world health organization ) and zika virus (world health organization ) have been marked by the limits of what can be known ahead of time and the challenges of responding to the particular turnings of outbreaks as they happen. the pandemic influenza-the topic of research i conducted with colleagues in australia and scotland-is a pivotal example of this problem of responding to a pandemic in real time. the pandemic put huge strain on global, national and local health systems, affecting many individuals and especially pregnant women and people with specific vulnerabilities to respiratory infections. it was a prominent, perhaps dominant, health news story of the period. but the pandemic turned out to be nothing like as severe as it was first thought to be. moreover, there was insufficient take-up of the h n vaccine (bone et al. ; galarce et al. ; white et al. ; yi et al. ) and it was observed that only minorities or small majorities reported that they intended to, or did, enact recommended social isolation to avoid transmission of the virus (kiviniemi et al. ; mitchell et al. ; rubin et al. ; van et al. ) . like the "swine flu affair" of the s in the united states (fineberg ) , the pandemic raised questions for the public health system of how to shape public action in light of the significant uncertainties which are particular to influenza, and without jeopardizing trust in government and the scientific knowledge on which is built public policy. central, too, was immunity, in its medical and social senses. immunity is not simply an object of biomedicine, it is also deeply entwined with collective life and the interrelations that come with, specifically, contagious diseases. it is also important to recognize that these issues are by no means settled; how individuals conduct themselves in relation to others in time of pandemic is a central and enduring concern for public health systems. in in the uk, for example, advertisements featured images of travellers on public transport and the following text: if you could see flu germs, you'd see how quickly they spread. cold and flu germs can live on some surfaces for hours. always carry tissues with you and use them to catch your cough or sneeze. bin the tissue, and to kill the germs, wash your hands with soap and water, or use a sanitiser gel. this is the best way to help slow the spread of flu. protect yourself and others (nhs swine flu information). this advice addresses responsible individuals and asks them to help limit the spread of infection. the final part of the message 'protect yourself and others' captures the idea that an easily spread influenza virus requires significant cooperation and the internalization of the idea of action on health for the collective good, as well as for oneself. this reference to altruistic action on health indicated that the social response to the pandemic exemplified biopolitics (rose ) . individuals are expected and encouraged to internalize the idea that they can take action on themselves to sustain and better their health and reproductive futures. this self-subjectification applies to the advice given to members of the general public on the influenza pandemic. in addition to the advice noted above, individuals were encouraged to arrange a network of "flu friends" who could be called upon in the case of illness, to stay abreast of developments in the media, and adopt expert advice (national health service ). publics were also advised to stay home if they suspected they were ill and to contact nhs services online or by telephone and to not attend gp surgeries of a&e, unless instructed to do so. in this view, the communications of hailed pandemic citizenship fashioned around the imperatives of action to avoid and contain the spread of infection and to make oneself available to expert advice. in what follows i explore pandemic communications under conditions of uncertainty, as exemplified by the influenza pandemic and its resonances with other recent contagions. as we will see, uncertainty has the effect of accentuating personalized responses to expert advice. it also sponsors communicative action figured around seeking the "just right" balance of warning and reassurance and related implications for trust in expert knowledge and authority to govern. the events of foregrounded many of the strengths and weaknesses of public health systems across the globe. key among these was preparedness and capacity to cope with large scale containment strategies which were used to manage the emerging pandemic. the pandemic preparedness plans in place in required that in the early phases of the pandemic, efforts should be made to sequester infected individuals and to trace their contacts so that the spreading infection could be tracked down and curbed (world health organization ). probably a central lesson of was that such efforts were costly and apparently ineffective. in some settings public health professionals were asked to continue this method even when they were aware that the virus was spreading quickly despite their best efforts . the pandemic therefore revealed the importance of being able to quickly assess the biological characteristics and severity of the infection so as to be able to modify the application of resources. since , public health systems have attended to the development of evidence-based measures to assess seriousness and the development of local and viable responses to a global pandemic threat (australian department of the prime minister and cabinet ). pandemic preparedness, therefore, has demonstrated a marked shift away from uniformity and top-down governance towards local, evidence-based, approaches. for example, australia's version of its preparedness plan adopted a traditional method of top-down transmission of expert knowledge and advice to publics. government in this view was mandated to: deliver consistent and accurate public messages nationwide in the event of a pandemic. governments will make every effort to provide timely and reliable advice to the public, media, businesses and industries. (australian department of health and ageing : ) by , however, the australian pandemic policy instrument referred to the need for public communications which were "two-way" and "listening" to publics (australian department of health : ). this approach to feedback on the transmission of information was said to depend on in vivo market research, the monitoring of social media, and a q&a website where publics can pose questions and air their opinions (australian department of health : ). the policy also made reference to the need for specific and tailored messages for vulnerable groups. however, during pandemic public communications faced significant challenges, not all of which are obviously addressed in the revised policies and their emphasis on feedback loops, market research and social media. surveys conducted at the time of the onset of the pandemic in show that while publics largely endorsed government action on the pandemic, they underestimated risk of infection and only minorities reported that they had adopted recommended behaviours such as social isolation and coughing and sneezing etiquette (rubin et al. ). the findings suggest that individuals interpreted public health advice with some scepticism. research shows also that espoused trust in government was associated with self-reported compliance with public health advice (lin et al. ; rubin et al. ). as noted, populations across the globe adopted vaccination only in small proportions, insufficient to protect the entire population. this indication of weak public engagement with the pandemic may be explained by a more general effect of risk management. it is surmised that the repetition of warnings over the last few decades-for example, hiv, bse, avian influenza, hospital superbugs, sars, h n , ebola and zika, to name a few-leads to weariness on the part of publics (joffe ) . diminishment in public engagement with risk is also thought to be an effect of risk society preoccupation with the forecasting and management of risks (giddens ) . public weariness can be thought of as a manufactured risk in the sense that it arises through attempts to manage risk. it is also evident that news on current risks are often framed by established patterns of meaning used to depict previous or contiguous risks (ungar ) . it is possible, therefore, that publics have learned to screen out global health alerts and treat media on the topic with a degree of scepticism, a perspective supported by our own davis ) and similar research (hilton and smith ; holland and blood ) . implied also is that repeated global health alerts coupled with some scepticism on the part of publics may lead them to fall back on personal knowledge and resources. the individualization of responses to pandemic risk communications was supported by our own research. individuals in our interviews and focus groups endorsed expert advice regarding coughing and sneezing etiquette and social isolation, but they did not think that these strategies would be viable in the long run . some of our respondents did adopt forms of social isolation, but they also saw in these strategies some flaws and inadequacies. they appeared, in general, to recognize the ease with which infection could occur. for these reasons, many of the people we spoke with resorted to discourse on immunity as a means of coping with a more than likely infection. almost absent was discourse on personal action as a means of protecting all, apart from among those with severe respiratory illness who were used to dealing with the threat of infection posed by others. our respondents focused on matters such as the building of immunity through consumer products, rest and exercise, and spoke of the need to cultivate and educate their personal immune system, with some reference to childhood experiences of exposure to infection. individuals seemed to accept that interaction with microbial life was inevitable and important to health and that their immune systems were shaped by their own actions. this "choice immunity" was spoken of as managing one's body and those of dependent others in ways that resonated with the well-known notion of "choice biography" which is said to characterize reflexive modernization (beck and beck-gernsheim ) . there are other implications of this resort to choice immunity. ed cohen has shown how immunity is a conceptual framing of subjectivity that preceded modern day microbiology ( ). with its root in the latin munis-also the root for municipal and remuneration, for example-immunity referred to the suspension of one's civic and pecuniary obligation to collective life. cohen gave examples which include, duty, gift, tax, tribute, sacrifice, and public office ( ). immunity suspends the "bond of requirement," but also, therefore, reinscribes it (p. ). it always and necessarily marks the power of the social obligation it refuses, including in matters of health. as cohen showed, microbiology, and specifically germ theory, appropriated and reconfigured the metaphor of immunity to help narrate the emerging science of cells, microbes and pathogenesis. in particular, the idea of immunity helped to explain how the immune system destroyed cells colonized by alien microbial life and bypassed uninfected cells of the body, although autoimmunity and microchimerism complicate this understanding of biological immunity (martin ) . combined with germ theory, immunity operates to produce a "milieu interieur;" an imaginary of the battle with microbial invaders inside the body (cohen : ), a metaphor which accentuates the emphasis on the individual in relation to contagious health threats. emily martin has made a similar point that media depictions of immunity have often referred to the war within the body ( ). it is therefore no surprise that individuals resort to the practical and metaphorical properties of immunity when they are asked to contend with the risk of pandemic influenza, which creates uncertainties over which they otherwise have very little apparent control. these issues are reflected in consumer products, for example, the commercial marketing of probiotic foods and supplements (burges watson et al. ; koteyko ; nerlich and koteyko ) , which address individual consumers in terms of "choice immunity." probiotics also raise the idea that it is important to replace bacteria that have been killed off due to antibiotic treatment and/or the idea that "good" bacteria will outcompete illness producing bacteria. the scientific underpinning and marketing of probiotics, then, depend on a division of "good" and "friendly" bacteria from disease-producing bacteria. it is against this backdrop of immunity culture that public health institutions have to shape and circulate messages on how individuals ought to conduct themselves. as with the pandemic, agencies such as the who, regional who offices, and lead national public health agencies such as the cdc and public health scotland implement communication strategies and are key sources of expert commentary in worldwide news media. a central communication challenge is how to shape messages so that they are productive of desired action on the part of members of the general public, when it cannot be known absolutely how matters will transpire. it is clear from our research with public health professionals in australia and the uk that finding a balance of motivation and reassurance was paramount (davis et al. (davis et al. , . in this context, public health experts were concerned that publics should be advised and asked to prepare for the pandemic but not in ways that promoted anxiety or promoted panic, as reflected in, for example, runs on supermarkets, pharmacies and clinics. this meant that messages also had to be reassuring but not in a way that led publics to ignore advice, or worse, to become complacent. as briggs and nichter have pointed out, pandemic messaging was carefully styled around the notion of "be alert, not alarmed" ( ). they have identified this approach as the "just right" goldilocks method, that is, the production of alert, but not panicky, reassured, but not complacent publics. for example, in a newspaper article published on april , in the first few days of the pandemic alert, the chief health officer of australia was quoted to have said: we should be aware but i'm not overly alarmed at this point. we don't have confirmed cases in australia but i think there will be some cases in the future. we think the population should be alert, should be aware of travellers in their midst who have the flu. but not alarmed at this point, just aware. (robotham and pearlman ) in this way, pandemic communications help to constitute the expert-informed, life choices of individuals. less obvious are obligations to others which also make immunity possible, such as herd immunity and the related practice of altruistic vaccination to protect vulnerable others. it is also important to recognize that explicit reference to immunity is rarely a feature of this public health advice; it is nearly always implied. the pandemic raised some other problems related to the eventual character of the pandemic as mild for most, but not all. as noted, the pandemic was quickly found to be less severe than early indications portended, though some groups faced elevated risks and the pattern of morbidity differed from that typical for seasonal influenza (presanis et al. ) . it therefore became necessary to manage the communications turn away from alert, but without the cessation of cautionary messaging and continued advice for those who did face higher risk of severe disease. influenza is known to return, on occasion, in a second wave which has the potential to be more severe for all or some of those affected (presanis et al. ) . uncertainties like these meant that it was imperative to sustain a kind of watchful, just in case, attitude, until such time as an effective vaccine became available. this particular situation of a global alert followed by revisions of preparedness and response and growing evidence of a significantly less dangerous pandemic led to new communications challenges to do with explaining to publics what was happening and how they should therefore conduct themselves. this shifting in messaging across the period of the pandemic implied "the boy who cried wolf " parable (nerlich and koteyko ) , which teaches in narrative form the jeopardy of trust faced by raising a false alarm, too often. one effect of false alarm is that it may amplify the importance of choice immunity, that is, recourse to the self-reliant management of the body as the means to contend with an uncertain health threat. sociological perspectives on choice biography point out that under the conditions of neo-liberal economic and political order, individuals are forced to rely on themselves and their own decision-making capacities, since there is in the end, nowhere else for them to go (beck and beck-gernsheim ) . they nevertheless are bound to depend on expert advice, since no one person can be expert in all the considerations that pertain to health or any other of the major life decisions (ungar ) . false alarm destabilizes expert authority and leaves people doubly reliant on themselves. in this view, the tendency for individuals to fall back on their immunity is a rational response to the requirement to take action and because, in the face of the uncertainties which preside in the case of influenza, the body is one apposite arena in which people are able to exercise some control. our research shows also that the communication on the pandemic had the potential to divide publics according to their vulnerability, another way in which knowledge and questions played out in the pandemic. they showed awareness of the "boy who cried wolf" dilemma but also recognized the invidious situation in which public health experts found themselves. they spoke of the needless hype of the media on the pandemic, by which they meant the extent of the reporting on the progress of the pandemic (davis and lohm forthcoming). it is important to remember, also, that some groups and individuals were affected and profoundly so, for example, women who were pregnant in . public communications on the risk of pandemic influenza, therefore, had a schismatic quality in the sense that the mildness of the virus needed to be explained to publics, while some remained at risk. like the universalism of pandemic preparedness, communications were also faced with the need for nuance and provisionality. this splitting of publics according to their vulnerability , was suggestive also of the coexistence of different modes of pandemic subjectivity. the "not at risk and in general unconcerned" could look upon news media and public communications as needless and hyped, particularly as the pandemic progressed. vulnerable groups, as we have suggested , at times had trouble recognizing themselves in these messages and once they had established for themselves awareness of their immunological vulnerability, they looked upon the hype as masking what for them was a real and visceral anxiety and set of practical issues of infection control and vaccination. this schism in public engagement accentuates the sense in which people have to make up their own mind on how to act in the context of what our vulnerable interviewees suggested were confusing, mixed messages. the communications challenges of emerging, changing pandemics are considerable. messages have to, at first, inform publics without frightening them, but also reassure them without producing complacency. as the example of the pandemic indicates, as the infection progressed and evidence emerged of the health effects of the h n virus, public health systems had to explain that the pandemic was mild, though this situation could change. they also had to embed in this more general message information for minorities that they remained at serious risk. this changing, complex message risked provoking accusations of false alarm and therefore mistrust, as has happened in previous outbreak situations (fineberg ) . as i argued, too, the mixing of a general message of a mild pandemic which might change with messages that also some particular kinds of people were at risk, placed vulnerable people in the difficult situation of having to identify themselves in these messages and take action when others were sceptical and unlikely to be acting to protect themselves and those around them. when we asked people in our research to talk about h n and specifically if it could be prevented, people acknowledged that infection was unlikely to be avoided and, accordingly, they were forced to reflect on the capacity of their body to cope with infection. as indicated, this resort to personal immunity was not quite the same as the science of cellular immunity discussed by cohen and others. it more closely resembled an acceptance of the possibility of the presence of the virus in the body and fashions an arena for volitional action on the body when other forms of action seem to have less practical value, as was the case in . for example, social isolation and possibly vaccination, were endorsed but by and large not extensively taken up, particularly given that the virus was in general mild and easy to catch. because the h n virus was observed to be so easily transmitted, the resort to personal immunity had doubled value. it may be for this reason that publics endorsed expert advice to self-isolate and vaccinate, but did not do so, that is, they fended for themselves and the pandemic turned into a mild one, anyway, though not for everyone. appeals to the collective good and altruistic vaccination on which depend public health efforts concerning pandemics, may miss the point that individuals are led to think of their personal immunity as an arena within which they can sustain themselves in the face of deeply uncertain threats which arise in communal life. if as cohen has suggested, immunity is fused with ideas of cellular action on microbial pathogens but it is also a metaphor for freedom from obligation. it seems, then, that a key lesson from was that freedom from the dangers of infection found in personal action on immunity also implied freedom from having to act in the interest of others; the more free one is from the dangers of infection-the stronger one's immunity-the less one needs to consider the dangers which others face, particularly under conditions of uncertainty. individualized ideas of immunity in connection with uncertainties may limit 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sectional telephone survey mobilising 'vulnerability' in the public health response to pandemic influenza misplaced metaphor: a critical analysis of the 'knowledge society global bird flu communication: hot crisis and media reassurance university life and pandemic influenza: attitudes and intended behaviour of staff and students towards pandemic (h n ) australia's pandemic influenza 'protect' phase: emerging out of the fog of pandemic influenza vaccine uptake in pregnant women entering the influenza season in western australia world now at the start of influenza pandemic report of the review committee on the functioning of the international health regulations ( ) in relation to pandemic (h n ) statement on the st meeting of the ihr emergency committee on the ebola outbreak in west africa world health organization predictors of the uptake of a (h n ) influenza vaccine: findings from a population-based longitudinal study in tokyo acknowledgements this chapter is based on research funded by an australian research council discovery project grant on pandemic influenza (dp ). i would like to acknowledge the assistance of my colleagues from the pandemic influenza project, niamh stephenson, paul flowers, emily waller, casimir macgregor and davina lohm. i am also very grateful for the time and efforts of those who participated in the interviews and focus groups for the research. key: cord- -fdn c hx authors: leanza, matthias title: the darkened horizon: two modes of organizing pandemics date: - - journal: how organizations manage the future doi: . / - - - - _ sha: doc_id: cord_uid: fdn c hx this chapter deals with the recent darkening of the future horizon in the global fight against pandemics. since roughly the year , the world health organization has collaborated with a large number of local actors and made a concentrated effort to protect the world’s population against emerging infectious diseases, such as severe acute respiratory syndrome (sars), swine flu, ebola and zika. although efforts have been made so that the spread of future infectious diseases will be contained through early intervention, the actors in charge anticipate that the extant measures will fail to some degree. they believe it is simply impossible to prevent all pandemics from happening. but steps can and should be taken to lessen the impact of an unavoidable pandemic through emergency preparation. this chapter deals with organizations and organizational networks as key actors in these processes of emergency planning. without the capacity of organizations to produce binding decisions for their members, which makes planning for an uncertain future possible, pandemic preparedness would not be feasible—especially not on a global scale. the horizon has darkened. the future no longer seems like an open space full of opportunities and risks. rather, what is in store appears to be deeply threatening. whether one thinks of global warming, terrorism or the continuing instability of the banking and finance sector, our expectations for the future in many areas of public life exemplify what craig calhoun ( , p. ) calls an 'emergency imaginary': 'a discourse of emergencies is now', as he wrote more than years ago in a diagnosis that is even more applicable today, 'central to international affairs. it shapes not only humanitarian assistance, but also military intervention and the pursuit of public health.' due to this emergency imaginary, we feel that our social institutions, our health and well-being, and even, as in the case of global warming, the future of mankind as such are deeply endangered. m. leanza (*) sociology department, university of basel, basel, switzerland this chapter deals with the recent darkening of the future horizon in the global fight against pandemics. around the year , the world health organization (who) started collaborating with a large number of local actors and made a concentrated effort to protect the world's population against emerging infectious diseases such as severe acute respiratory syndrome (sars), swine flu, ebola and zika. although efforts have been made so that the spread of future infectious diseases will be contained through early intervention, the actors in charge expect the extant measures to fail to some degree. they believe it is simply impossible to prevent all pandemics from happening. but steps can and should be taken through emergency preparation to lessen an unavoidable pandemic's impact. as andrew lakoff ( , pp. - ) summarizes: preparedness assumes the disruptive, potentially catastrophic nature of certain events. since the probability and severity of such events cannot be calculated, the only way to avert catastrophes is to have plans to address them already in place and to have exercised for their eventuality-in other words, to maintain an ongoing capability to respond appropriately. in recent years, scholars of security studies, cultural studies and other research areas have paid much attention to these developments in emergency preparedness, which, it is worth noting, are not limited to the domain of public health. this issue has primarily been addressed at two levels: first, by changing global security policies after the / attacks, and, second, by scrutinizing the narratives and rhetorical strategies through which the emergency imaginary is constructed and gains plausibility (e.g. massumi ; aradau and van munster ; horn ) . in this chapter, i will focus on organizations as key actors in these processes of emergency planning. without the capacity of organizations to produce binding decisions for their members, which allows them to plan for an uncertain future, pandemic preparedness would not be feasibleespecially not on a global scale. i will unfold my argument in four steps. with regard to the who, which was established in , i will discuss the question of how supranational coordination and planning for the future is rendered possible by building formal organizations and organizational networks at a global level. i will then highlight some aspects of the attempts undertaken by the who and its partners after the year to fight pandemics on a global scale. my analysis of relevant policy papers, legal norms and manuals shows that two different though complementary strategies are applied: early intervention and emergency planning. these are, as i will discuss more explicitly in the final section, two different kinds of organizing (for) the future or, to put it differently, two modes of how organizations manage pandemics. the overall aim of the empirical analysis offered in this chapter is to reconstruct organizational programmes and rationales rather than to give an account of the actual operations of these systems. the focus lies on public discourses and normative texts and not so much on the 'inside' of these organizations, meaning their day-to-day routines and practices. contagious diseases do not stop at state borders. pathogens circulate without regard for political and administrative spheres of influence. what gilles deleuze and félix guattari ( , introduction) establish for rhizomes in general also applies to infection chains in particular: by growing rampantly, they produce a 'deterritorializing effect'. pathogens connect distant regions and different kinds of people; zoonoses even trespass the boundary between animals and humans. by doing so, communicable diseases create spaces and communalities that did not exist before. this is also the reason why every epidemic requires new maps (e.g. koch ) . even though pathogens do not stop at state borders, sovereignty ends there, and the difficult terrain of diplomacy begins. the international sanitary conferences, which took place between and , made a first step towards creating a global field of public health (howard-jones ; bynum ) . while the first couple of these conferences-there were in all-dealt primarily, though not exclusively, with cholera, further diseases and topics were discussed and negotiated beginning in the s. laborious agreements regarding quarantine, inspection and surveillance measures were worked out and in some cases ratified. but the field of global health diplomacy did not receive a coordination and control unit until with the establishment of the who as a specialized agency of the united nations (zimmer ) . in passing the international health regulations (ihr) of , which superseded the international sanitation regulations of , the who established standards and norms with a legally binding character for its signatory states. the primary goal of these regulations was to provide 'maximum security against the international spread of disease with the minimum interference with world traffic' (who , p. ) . to this end, epidemiological surveillance and alarm systems were installed in signatory states, or already existing structures were expanded. in addition, the who made more specific efforts to combat infectious diseases. one of the first large projects was the global malaria eradication program ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . in order to defeat the dangerous tropical disease, the insecticide ddt (dichloro-diphenyl-trichloroethane) was used liberally and repeatedly in over countries. even though certain regions profited from this measure, the actors in charge had to accept in the end that this goal was, on the whole, too ambitious (zimmer , pp. - ) . more successful, however, was the vaccination programme against smallpox, which was enacted in and intensified in (fenner et al. (fenner et al. , pp. - , . after roughly years, it finally reached its goal. in , the who announced: 'smallpox is dead!' (ibid., p. ). sovereign nation states use the mechanism of formal organization to cooperate in this and further policy areas of international concern. while 'leagues of subjects' within a state 'savour of unlawful design', as thomas hobbes ( , p. ) famously wrote in leviathan, 'leagues between commonwealths, over whom there is no human power established to keep them all in awe, are not only lawful, but also profitable for the time they last'. as well as mutual agreements and legally binding contracts, inter-or supranational organizations are a specific form taken by such leagues today. drawing on niklas luhmann ( ) , organizations can be perceived as a type of social system that is defined by formal membership roles and processes of decision-making. as inter-or supranational organizations demonstrate, not only natural but also legal persons, such as states, can become members of organizations. by entering an organization, sovereign nation states are, in principle, capable of producing collectively binding decisions on a global level, without losing their autonomy to a sovereign world state. today, a wide range of organizations constitute the global field of public health and disease control (youde , part ) . besides the who, they include the world bank, unaids (which was established in ) and governmental and nongovernmental organizations. these organizations are the main action centres within the field of global public health. they deliver expertise, develop policies, launch programmes and mobilize the global community. to achieve their goals, they regularly ally with other organizations and build networks that can be activated when necessary. this especially holds true for the global fight against pandemics. in certain respects, in order to deal with an unfolding threat, organizational networks have to spread as rampantly as the pathogens themselves. otherwise they will be unable to prevent further harm. in , and thus very much in the shadow of the global aids crisis, the who laid the foundation for a new regime in the global fight against pandemics by setting up the global outbreak alert and response network (goarn). since then it has acted in more than cases (mackenzie et al. ). through 'rapid identification, verification and communication of threats' (who , p. ), goarn seeks to contain the spread of infectious diseases, especially highly infectious ones. 'no single institution or country', so the main argument for this international cooperation goes, 'has all of the capacities to respond to international public health emergencies caused by epidemics and by new and emerging infectious diseases' (who n.d.) . in - , the sars pandemic, which resulted in nearly registered deaths, triggered a global health alarm due to goarn, though the communication of this risk kindled by the predicted future potential of the pandemic outstripped, in certain respects, its actual impact (smith ; ong ). the thoroughly redesigned ihr from , which came into force in , further developed and shaped this process. in contrast to the regulations it replaced-the international sanitation and health regulations of and , which, in comparison, were quite static since they only applied to a specific catalogue of communicable diseasethe ihr now includes an early warning system that seeks to detect every potential 'public health emergency of international concern' (pheic) (fidler ) . the focus is on so-called points of entry, especially sea-and airports (who a, pp. - , - ) . the member states of the who are responsible for implementing this global safety net at the local level; they must establish surveillance, contact and coordination units. in germany, for instance, the federal office of civil protection and disaster assistance coordinates and oversees this implementation process in cooperation with the robert koch institute. the robert koch institute, in turn, works with the european centre for disease prevention and control, which is an important partner of goarn. because many different kinds of organizations across a wide range of countries are connected in this network, it is necessary to standardize decision-making. without the 'structural coupling' (maturana and varela , pp. - ) of a shared decision process, cooperation and coordination between the participating organizations would not be feasible. decisions would simply not be able to circulate within the network. instead, they would have to be re-evaluated at every nodal point. for this reason, the ihr (who a, pp. - ; see also who ) stipulates a risk-assessment matrix for signatory countries: after a local surveillance unit has detected an event 'that may constitute a public health emergency of international concern' (who a, p. ) , three yes/no questions regarding its actual and potential impact must be answered. then, it is determined whether the event should be rated as unusual or unexpected. if the answers are all positive, the who must be notified within hours. if they are not all positive, there are two further levels of such yes/no questions, which address the risk of international spread and, in a final step, the possibility that countries or other entities would impose international travel or trade restrictions in response to the outbreak. the answers to these questions then determine whether notifying the who is required or not. this decision-making tool can be understood as an 'attention filter'. since there are now many globally connected surveillance units, mechanisms have to be installed that not only allow and trigger but also suppress communication between them. otherwise, the network would be flooded with more information than it can process. in other words, the elements within this structure would be too closely connected. nonetheless, the goal is to set the attention thresholds as low as possible. even if notifying the who is not required at one point, the event in question has to be kept under surveillance. this, of course, does not prevent the situation from being evaluated incorrectly. the - ebola outbreak, for instance, was declared a pheic relatively late because the actors in charge initially viewed it as only a local problem of a poor region in west africa (lakoff et al. ) . together with the attention thresholds, the reaction times of the relevant public health organizations are also to be lowered. while the decentralized structure of networks improves the alarm function, since attention is widely distributed, a missing or weakly developed action centre has an adverse effect on the intervention function. in defiance of all network rhetoric, the global fight against pandemics cannot proceed without the structural principles of hierarchy and the distribution of tasks. according to the ihr, after being informed of a positive risk assessment by local organizations, the who has to provide them with further information and instructions and send experts to the affected regions (who a, pp. - , - , - ) . the who is the 'obligatory passage point' (callon ) for this process. a combination of the network, hierarchy and the distribution of tasks aims to make rapid intervention possible. even though the who wants, in principle, global traffic to flow without any hindrance, in some cases a temporary interruption of the circulation of goods and people may be considered necessary to protect global public health (stephenson ; opitz ) . the ihr and national regulations therefore stipulate travel restrictions on certain people and allow measures like quarantine and isolation to be imposed. in an age of global flows and a greater awareness of fundamental rights, this specific kind of intervention has to some extent become problematic. as the first principle of the ihr states 'the implementation of these regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons' (who a, p. ) . similarly, the who ( , p. ) explained in : 'in emergency situations, the enjoyment of individual human rights and civil liberties may have to be limited in the public interest. however, efforts to protect individual rights should be part of any policy. measures that limit individual rights and civil liberties must be necessary, reasonable, proportional, equitable, non-discriminatory and in full compliance with national and international laws.' besides these reservations, the global fight against pandemics cannot proceed without restrictive measures, as the sars pandemic and ebola outbreak have shown. although a concentrated global effort has been made to prevent pandemics via early detection and rapid response, the actors in charge expect them to happen. it is only a matter of time, they believe, until the next health emergency occurs. 'influenza experts agree', the who ( b, pp. vi-vii) warned in , 'that another pandemic is likely to happen but are unable to say when. the specific characteristics of a future pandemic virus cannot be predicted. nobody knows how pathogenic a new virus would be, and which age groups it would affect.' although its exact time of emergence, etiological nature and epidemiological distribution pattern may be unpredictable, it is considered a fact that the next pandemic will occur in the near or not so distant future (see also macphil ). a glossy brochure on pandemic planning by the us department of homeland security ( , p. ) presented a similar way of looking at things. in a quotation in the brochure, the us secretary of health and human services, mike leavitt, states: 'some will say this discussion of the avian flu is an overreaction. some may say, "did we cry the wolf?" the reality is that if the h n virus does not trigger pandemic flu, there will be another virus that will. ' this statement demonstrates that the general trend of thinking about emergencies and accidents as 'normal' has permeated the field of global public health (calhoun ; lakoff ) . in the s, in many areas of public life, the future was already perceived as unsafe and potentially catastrophic, and this view was intensified after the year (aradau and van munster ; horn ) . although the future horizon has darkened with the looming prospect of ecological, political and economic crises, not all hope is lost. the occurrence of (massive) harm might be inevitable, but what can yet be prevented is the worst-case scenario. it is assumed that through emergency planning, the severity of the potential damage can be lessened. this is what 'preparedness' means: acting, deciding and governing under conditions of insecurity (lentzos and rose ; anderson ) . as the who explained in : 'although it is not considered feasible to halt the spread of a pandemic virus, it should be possible to minimize its consequences through advance preparation to meet the challenge' (who c, p. ) . in his address to the nd world health assembly in , the un secretary-general, ban ki-moon, posed the same question: 'how do we build resilience in an age of unpredictability and interconnection?' through emergency planning is his answer. 'this is how we will make the global community more resilient. this is how we ensure that wherever the next threat to health, peace or economic stability may emerge, we will be ready.' of special interest in this regard are critical infrastructures, such as water supply, that might be affected by a severe disease outbreak. local public health emergency centres, which the who ( ) assembled as a global network (eoc-net) in , are responsible for the planning process. as well as taking stock of the available resources and contingents in a country or region, scenario planning and agent-based computer simulations are of fundamental importance ; they enable us to imagine possible scenarios via enactment and visualization without the necessity of making any probability assumptions. it is believed that in order to be prepared for future emergencies, the organizational imagination must to some extent be liberated from restrictions imposed by past experiences. organizations are of crucial importance for the planning process. for instance, the who guidelines, whole-of-society pandemic readiness, aim 'to support integrated planning and preparations for pandemic influenza across all sectors of society, including public and private sector organizations and essential services' (who , p. ) . to strengthen organizational resiliency against the stresses and strains that may result from a pandemic, thorough preparation is required. 'in the absence of early and effective planning, countries may face wider social and economic disruption, significant threats to the continuity of essential services, lower production levels, distribution difficulties, and shortages of supplies' (p. ). emergency planning is furthermore imperative since '[t]he failure of businesses to sustain operations would add to the economic consequences of a pandemic. some business sectors will be especially vulnerable (e.g. those dependent on tourism and travel), and certain groups in society are likely to suffer more than others' (p. ). the 'readiness framework' therefore asks all organizations that provide basic services such as food, water, health, defence, law and order, finance, transportation, telecommunications and energy to prepare for pandemics via simulation exercises and drills based on different scenarios. furthermore, business continuity plans have to be developed. for this purpose, a pandemic coordinator should be assigned to oversee the planning process. all organizations that are crucial for public life are strongly advised to prepare themselves for the next pandemic. given the interdependencies between these organizations, general preparedness is the only way to prevent a complete breakdown. or, as the guidelines put it: 'it is prudent to plan for the worst, while hoping for the best' (p. ). according to lakoff ( ) , today's highly differentiated field of global health is characterized by, among other things, the juxtaposition of two regimes: global health security and humanitarian biomedicine. 'each of these regimes', he elaborates, 'combines normative and technical elements to provide a rationale for managing infectious disease on a global scale. they each envision a form of social life that requires the fulfillment of an innovative technological project. however, the two regimes rest on very different visions of both the social order that is at stake in global health and the most appropriate technical means of achieving it' (p. ). while global health security turns its attention to emerging infectious diseases, 'which are seen to threaten wealthy countries, and which typically (though not always) emanate from asia, sub-saharan africa, latin america', humanitarian biomedicine deals with 'diseases that currently afflict the poorer nations of the world, such as malaria, tuberculosis, and hiv/aids' (p. ). in addition to lakoff's ( lakoff's ( , see also distinction between the two regimes of global health, my analysis highlights two layers that are encompassed by one of these regimes, the global fight against emerging infectious diseases. the two modes of organizing of such pandemics are not organizations themselves. they are programmes that structure the organizational decision-making and the corresponding membership roles. in analysing these programmes, the focus lies not so much on the actual operation of the system-since it is always a creative translation of cognitive and normative schemes into concrete practice-but rather on the intended actions of the system. a first line of defence is defined through early intervention. for this purpose, a wide and ramified organizational network is put in place. it allows pandemics to be detected while they are still emerging, and this makes it possible to limit the potential scope of their spread. because the goal is to prevent a further unfolding of potential threats into actual damages, time is of the essence in detection. the organizations must react quickly while ensuring, at same time, that the information they generate, process and communicate to others is reliable. the strategies they decide to follow also have to be effective. otherwise the primary goal is not achieved: preventing pandemics from happening. in reality, this highly ambitious goal cannot always be met. but the organizations in charge know their limitations and are therefore requested to install a second line of defence: emergency planning. all organizations that are critical for society are asked to have emergency plans in place so that, in the case of a pandemic, they would still be able to react. the goal here shifts from preventing the spread of disease towards securing the 'autopoiesis' (maturana and varela , pp. - ) of the system, meaning its ability to reproduce itself even under enormous environmental pressures. while early intervention requires organizations to be capable of acting quickly, pandemic preparedness aims to produce robust systems that are immune to breakdown. despite operating from different angles, these two modes of organizing pandemics are complementary. early intervention relates to preventable damages. the underlying assumption is that pandemics can be avoided through early detection and rapid response. the future scenario of early intervention is therefore an altogether positive one, in which organizations are capable of doing their job in the face of danger, namely containing infectious diseases. pandemic preparedness, in contrast, works not with one but with two kinds of damages: primary damages, which cannot be prevented, and preventable consequential damages, which pose an existential threat. the aim is still to prevent harm, but preparedness does not focus on the pandemics per se but on the fatal repercussions that they might have for societies. this is a minimal form of prevention, and it is no longer believed that it is possible to escape such a pandemic unscathed. both modes of relating to the future do not exclude but rather complement each other. if early intervention does not work in a specific scenario, there is still a second prevention strategy, which, of course, can only partially contain the effects of the pandemic since (massive) harm will have already occurred. but by strengthening the resilience of organizations and societies, pandemic preparedness aims to preserve existential functions and operations. in his by now classic essay from , charles perrow describes organizations, especially large ones, as a key element of modern societies. according to perrow, fundamental social functions are maintained by private and public organizations. this also holds true for responding to pandemics. in a 'society of organizations' (perrow ) , it is organizations and their professionals who manage pandemics. but two kinds of organizations have to be distinguished which correspond to the two modes or programmes for managing emerging infectious diseases: first, organizations and professionals in the public health sector try to prevent pandemics through early intervention (and further preventative measures, such as vaccination programmes). it is their job to protect the general public from health risks; this is the purpose of these specialized organizations and the goal of their corresponding professional activities. second, and in contrast, all organizations that provide basic services for society are asked to make emergency plans and prepare themselves for the next pandemic. this includes public health organizations but is also addressed to, first and foremost, private and public organizations that provide food, water, defence, law and order, finance, transportation, telecommunications and energy. the second programme is no less ambitious than the first. organizations and professionals in the public health sector may not always succeed in preventing pandemics: as we have seen, they are well aware of this fact, and that is why emergency plans are developed in the first place. but this implies that, in principle, all organizations that provide basic services for society have to professionalize themselves in this specific area. one could describe this as a 'colonization' of non-health organizations through public health imperatives. this is, of course, not a completely new development if one considers, for instance, company doctors or health and safety officers. furthermore, many large organizations have undergone a professionalization in areas that do not traditionally belong to their core activities, such as when they maintain legal, public relations or research departments, or when they offer childcare or psychological counselling to their employees. to some extent, this is a likely consequence of the 'functional differentiation of modern societies' (luhmann ) : even if organizations are typically specialized in providing only one or two services, they have to take further social functions into account. what is new here is the kind of task, that is, preparing for pandemics in order to prevent the worst-case scenario-a complete breakdown of the system that would result from the absence of employees due to illness. in a society of organizations, the autopoiesis of society as whole cannot be separated from the autopoiesis of its organizations. preserving society in a public health emergency depends on keeping organizations functional. for measures of disease assessment and control in germany, see the 'gesetz zur neuordnung seuchenrechtlicher vorschriften for a discussion of how biosecurity intertwines the field of public health with the security sector, see also fidler and gostin preemption, precaution, preparedness: anticipatory action and future geographies politics of catastrophe: genealogies of the unknown policing hearts of darkness: aspects of the international sanitary conferences a world of emergencies: fear, intervention, and the limits of cosmopolitan order some elements of a sociology of translation: domestication of the scallops and the fishermen of st brieuc bay pandemic influenza: preparedness, response, and recovery; guide for critical infrastructure and key resources european centre for disease prevention and control smallpox and its eradication from international sanitary conventions to global health security: the new international health regulations biosecurity in the global age: biological weapons, public health, and the rule of law leviathan or the matter, forme & power of a common-wealth ecclesiasticall and civil the scientific background of the international sanitary conferences - resilience and solidarity: our best response to crisis. address to the nd world health assembly mapping medical disasters: ebola makes old lessons preparing for the next emergency two regimes of global health governing insecurity: contingency planning, protection, resilience funktionen und folgen formaler organisation the global outbreak alert and response network a predictable unpredictability: the h n pandemic and the concept of 'strategic uncertainty' within global public health fear (the spectrum said) the tree of knowledge: the biological roots of human understanding assembling around sars: technology, body heat, and political fever in risk society regulating epidemic space: the nomos of global circulation defining epidemics in computer simulation models: how do definitions influence conclusions? a society of organizations responding to global infectious disease outbreaks: lessons from sars on the role of risk perception, communication and management emerging infectious diseases/emerging forms of biological sovereignty who checklist for influenza pandemic preparedness planning. geneva: who. ---. c. who global influenza preparedness plan: the role of who and recommendations for national measures before and during pandemics welt ohne krankheit: geschichte der internationalen gesundheitspolitik - key: cord- -l f gp authors: nan title: oral and poster manuscripts date: - - journal: influenza other respir viruses doi: . /j. - . . .x sha: doc_id: cord_uid: l f gp nan pandemic influenza h n (h n pdm) virus of swine-origin causes mild disease, but occasionally is associated with acute respiratory distress syndrome and death. , it is important to understand the pathogenesis of this new disease. previously we showed a comparable virus tropism and host innate immune responses between h n pdm and seasonal h n influenza virus in the human respiratory tract, however h n pdm virus differed from seasonal h n influenza virus in its ability to replicate in human conjunctiva, suggesting subtle differences in receptor-binding profile and highlighting the potential role of the conjunctiva as an additional route of infection. we now compare the tropism and host responses elicited by pandemic h n with that of related swine influenza viruses and a pandemic-swine reassortant virus in ex vivo and in vitro cultures of the human respiratory tract and conjunctiva. we have used recombinant virus to investigate the role of the hemagglutinin (ha) and neuraminidase (na) of h n pdm virus in its conjunctival tropism. these findings are relevant for understanding transmission and therapy. fragments of human conjunctiva, bronchi, and lung tissues were cut into - mm fragments within h of collection and infected with influenza a viruses at a titer of tcid ⁄ ml. viruses investigated included h n pdm (a ⁄ hk ⁄ ⁄ ), swine h n virus (a ⁄ swine ⁄ hk ⁄ ⁄ ), which shares a common derivation for seven genes with h n pdm, a natural swine reassortant h n (a ⁄ swine ⁄ hk ⁄ ⁄ ), which has acquired the na gene from h n pdm and other swine influenza h n viruses. reverse genetics derived recombinant viruses with ha and na gene segments of seasonal h n and pandemic h n swapped were also studied. lung fragments were cultured at °c in culture plates; conjunctival and bronchial biopsies were cultured in air-liquid interface at and °c respectively. tissue fragments were infected for h and incubated for , , and h post infection. infectious viral yield was assessed by titration in mdck cells. the infected tissues were fixed with formalin and analyzed by immunohistochemistry for influenza antigen. cytokines profiles induced by influenza virus infected respiratory epithelial cells in vitro were measured by quantitative rt-pcr and elisa. we found comparable replication in seasonal and pandemic h n viruses in human respiratory tract, while the swine influenza a ⁄ swine ⁄ hk ⁄ ⁄ (h n ) virus and a ⁄ swine ⁄ hk ⁄ ⁄ (h n ) virus failed to infect and replicate in human lung ex vivo culture, but it replicated productively in human bronchus ex vivo. interestingly, the swine reassortant influenza h n (a ⁄ swine ⁄ hk ⁄ ⁄ ) virus (with the na from h n pdm) infected and productivity replicated in lung ex vivo and in vitro. pandemic h n pdm virus, but not seasonal h n virus, was able to infect ex vivo cultures of human conjunctiva, suggesting subtle differences in receptor binding profile in h n pdm, seasonal viruses, and the swine related h n viruses. using reverse genetics derived recombinant viruses, we were able to demonstrate that the ha and na segments of h n pdm, but not the polymerase genes, were required for the conjunctival tropism of h n pdm ( figure ). in contrast with highly pathogenic influenza h n virus, which induced high cytokine and chemokine decretion, the related swine viruses, a ⁄ swine ⁄ hk ⁄ ⁄ (h n ), as well as the swine pandemic reassortant virus, a ⁄ swine ⁄ hk ⁄ ⁄ (h n ) we studied were similar to h n pdm and seasonal influenza viruses in their intrinsic capacity for cytokine dysregulation. collectively, our results suggest that pandemic h n pdm virus differs in modest but subtle ways from seasonal h n virus in its intrinsic virulence for humans, findings that are in accord with the epidemiology of the pandemic to date. the ha and na gene segments are key to the conjunctival tropism manifested by the h n pdm virus. the pandemic reassortant influenza h n (a ⁄ swine ⁄ hk ⁄ ⁄ ) virus isolated from swine with the na from h n pdm shares with h n pdm the capacity for productive replication in lung ex vivo and in vitro. these findings are relevant for understanding transmission and therapy. isolation of influenza viruses from specimens is traditionally performed in two classical systems: embryonated chicken eggs and mdck cell culture. nevertheless, several publications are dedicated to the theme of alternative cell culture systems, which may be used for influenza virus isolation and cultivation. [ ] [ ] [ ] this is in part because mdck cells are of animal origin, which means that they cannot be used as a proper model for estimating interactions between a human virus and a human cell culture as a host. a variety of human monolayer and suspension cell cultures have been tested on their capability to support influenza virus replication. among them, some support influenza a virus growth as well as mdck cells do, others support replication of a virus, but do not enable the formation of mature viral particles, whereas others show only a weak level of replication or are not permissive at all. caco- cells, for example, represent a good substitute for mdck cells, because it has been shown that the rate of viral isolation in caco- cells is as effective as in mdck, and sometimes is even better. the success of viral replication is determined not only by the cell culture type, but also by the virus itself. despite the accepted view that it is the type of receptor that defines the interaction between the virus and the host cell, there is evidence that it is not the only factor that predetermines the fate of the cell. the fate of the infected cell can also differ. a series of articles show that apoptosis is the most probable mechanism of cell killing by influenza viruses. , influenza a viruses of different subtypes induce apoptosis to a different extent (e.g. h viruses provoke more strong apoptotic response than h viruses do ). nevertheless, it has been demonstrated that caco- cells do not follow the apoptotic pathway and die through necrosis. the sjpl cell line also dies through necrotic pathway and not apoptosis. the aim of our work was to compare growth characteristics of different flu viruses (e.g. avian, swine, and human) in various human and animal cell cultures and to evaluate their influence on cell culture growth. the parameters measured in the study were as follows: cytopathic changes of cell cultures following virus infection, hemagglutinin production, np synthesis, the dose-dependent effect of infection on cell proliferation, and the ability of viruses to induce apoptosis. influenza viruses used included: highly pathogenic avian h n a ⁄ kurgan ⁄ ⁄ , low pathogenic avian h n a ⁄ gull ⁄ kostanai ⁄ ⁄ , swine h n a ⁄ swine ⁄ ⁄ , human h n v a ⁄ california ⁄ ⁄ , human h n v a ⁄ saint-petersburg ⁄ ⁄ , human h n a ⁄ brisbane ⁄ ⁄ , and human h n a ⁄ brisbane ⁄ ⁄ . the viruses were propagated in -days embryonated chicken eggs, the allantoic fluid was collected, the aliquots were made and stored at ) °c for further use. to evaluate tcid for each virus on all cell cultures, -well plates were used. the cells were seeded ae ml per well (concentration of - ae · cells ⁄ ml). the confluent -h old monolayer was used for viral inoculation. the cells were washed twice with serum-free medium, then ae ml of tenfold viral dilutions from viral aliquots were added and left for min for contact at °c. the cells were then washed to remove the non-attached particles, and the wells were filled with tpck-trypsin ( lg ⁄ ml)-containing medium without bovine fetal serum. the plates were observed daily for cytopathic effect, and the results were evaluated at h after infection for cytopathic effect and by reaction of hemagglutination with suspension of chicken erythrocytes ( ae %). infection of suspension cell cultures was done in centrifuge tubes. cells (concentration - · ) were inoculated with viral dilutions (moi = - ). after min of contact, cells were washed, resuspended in rpmi with trypsin and fetal serum, and seeded in -well plates ( ml in each well). the results were fixed after h, calculating the number of cells grown and estimating the rate of apoptosis by hoechst- staining. cells were grown in -well plates with seeding concentration · cells ⁄ ml. one millilitre of cell suspension was placed in each well, inoculated with viral dilution (moi = - ) and left for h. after, the cells were detached from plastic with versene and calculated in fuks-rosental camera to evaluate the number of cells. the monoclonal antibodies obtained in research institute of influenza towards viral nucleoprotein np were used following the standard protocol described in. for all viruses tested, mdck turned out to be more permissive than sp cell culture. avian viruses, independently of their pathogenicity, replicated efficiently on both animal cultures tested. human h n and h n viruses demonstrated weaker replication in sp cells. the most significant differences were seen for swine influenza and pandemic h n v viruses which replicated in mdck cells at the rates comparable with other viruses, but showed poorer growth in sp cell line (see table ). human cell lines displayed clear differences in their susceptibility to viruses of various origins. avian influenza viruses replicated in all cell lines except girardi heart, and the most intense replication rate was observed for ecv- , l- , and rd lines. a- and a- were poorly infected, as well as all suspension cell lines tested. seasonal human h n , as well as h n viruses, replicated in all cell cultures tested, but the rate of infectivity was rather low in practically all cultures tested with the exception of rd and t- g cell lines. strikingly, swine influenza virus and human pandemic h n v viruses didn't replicate well in any of human lines tested. a weak replication rate was observed in ecv- , rd, and t- g, but in general, human cell lines were the titers produced by swine and pandemic influenza viruses are shaded in grey. *low-pathogenic avian influenza virus; **highly-pathogenic avian influenza virus poorly susceptible to pandemic h n v. swine influenza virus differed because it infected weakly a- and girardi heart cell cultures, which was not the case for h n v viruses. our study has shown that all influenza viruses were able to induce apoptosis in the cell cultures tested. the degradation of chromatin found in the nucleus with hoechst- staining was seen before the first symptoms of cytopathic effect (cpe) in monolayer of cells. in cell cultures where the cpe was not visible, high doses of virus still induced apoptotic response. the process of apoptosis is rather well studied in mdck cells and some other cell types, so we've focused on three human monolayer cell cultures that are relatively poorly studied: a- , ecv- , and flech. these cell cultures are less susceptible to viral infection, and besides, it was interesting to find out whether the viruses that do not cause any cpe do infect these cultures. a- turned out to be most sensitive to apoptotic response, while flech turned out to demonstrate weak reaction. time needed for apoptosis induction by different flu viruses also varied. the earliest apoptosis was noted for h n and h n viruses and h n viruses induced apoptosis at about h postinfection. it is well-known that apoptosis can be induced only by a reproducing virus, and that uv-kills viruses that are not capable of it. we tested whether swine and pandemic h n v viruses (that do not show cpe in these cultures) do replicate in them and induce apoptosis with the help of monoclonal antibodies against viral np. the obtained data show that they indeed do replicate in these cell cultures, as we observed np fluorescence, and that they also induce apoptosis (see table ). we've shown earlier thus, we've tested the ability of swine and pandemic h n v viruses in this aspect. it was shown that these viruses were comparable with the effect seen for seasonal h n virus. moreover, swine influenza virus induced stronger apoptotic response in hemablastoid cell lines in comparison with pandemic h n v viruses, which also have a swine origin. we also checked the ability of flu viruses to influence monolayer cell cultures growth. the data clearly indicated that only ecv- endothelial line and t- g glioblastoma line displayed cell proliferation in response to low moi. apoptosis wasn't registered in these stimulated cultures, apparently because the moi was very low. all the other monolayer cultures didn't respond to low moi by stimulation of their proliferation. interaction between an influenza virus particle and a host cell can follow several scenarios. cpe seen in infected cells is accompanied with high rates of viral particles production and leads to cell death. the death itself may be through apoptotic or necrotic pathways. , also, infection process in low doses can stimulate cell proliferation -the effect seen for hemablastoid lines, histiocytes, peripheral blood cell lines, , and in glioblastoma and endothelial cell lines as it was described here. considering the origin of ecv line, these cells bear all the antigenic, biochemical, and physiological traits of umbilical cord and are actively used in pharmacological tests as well as glioblastoma cells; they also are of special interest for oncogenesis studies. table . replication, apoptosis induction, and np synthesis of influenza viruses in a- , ecv- and flech cell cultures. the numbers represent the log tcid ⁄ ae ml calculated by reed-muench method as described in. the ()) symbol means that no cpe could be observed in any dilution and no hemagglutination could be registered. the (+) symbol means that apoptosis was observed with hoechst- staining though the productive replication and production of progeny viruses in human cell lines was generally low, it is evident that viral infection does occur in these cells, even for swine and h n v viruses. it can be demonstrated by the presence of np de novo synthesis and by stimulation of virus-induced apoptosis. in fact, we observe a contradiction: avian influenza viruses actively reproduce in human cell lines, but we do not see their vast spreading in human population, while h n v viruses that hardly replicate in all human cultures tested have caused the latest pandemic. influenza viruses continue to cause problems globally in humans and their livestock, particularly poultry and pigs, as a consequence of antigenic drift and shift, resulting frequently and unpredictably in novel mutant and reassortant strains, some of which acquire the ability to cross species barriers and become pathogenic in their new hosts. long-term surveillance of influenza in migratory waterfowl in north america and europe have established the importance of anseriformes (waterfowl) and charadriiformes (gull and shorebird) in the perpetuation of all known subtypes of influenza a viruses. the available evidence suggests that each of the hemagglutinin (ha) and nine neuraminidase (na) subtype combinations exist in harmony with their natural hosts, cause no overt disease, and are shed predominantly in the feces. , in this study we determined the subtypes and prevalence of low-pathogenic influenza a viruses present on the territory of kazakhstan in - and further analysed the ha and na genes of these isolates in order to obtain a more detailed knowledge about the genetic variation of influenza a virus in their natural hosts. (institute for biological safety problems, gvardeiskiy, zhambyl oblast, kazakhstan)). samples that were identified as influenza a virus positive by matrix rrt-pcr were thawed, mixed with an equal volume of phosphate buffered saline containing antibiotics (penicillin u ⁄ ml, streptomycin mg ⁄ ml, and gentamicin lg ⁄ ml), incubated for minutes at room temperature, and centrifuged at g for minutes. the supernatant ( ae ml ⁄ egg) was inoculated into the allantoic cavity of four -day old embryonated hens' eggs as described in european union council directive ⁄ ⁄ eec. embryonic death within the first hour of incubation was considered as non-specific, and these eggs were discarded. after incubation at °c for days the allantoic fluid was harvested and tested by haemagglutination (ha) assay as describe in european union council directive ⁄ ⁄ eec. in the cases where no influenza a virus was detected on the initial virus isolation attempt, the allantoic fluid was passaged twice in embryonated hens eggs. the number of virus passages in embryonated eggs was limited to the maximum two to limit laboratory manipulation. a sample was considered negative when the second passage ha test was negative. the subtypes of the virus isolates were determined by conventional haemagglutination inhibition (hi) test and neuraminidase inhibition (ni) test, as describe in european union council directive ⁄ ⁄ eec. rna extraction and pcr with specific primers rna was extracted from infective allantoic fluid using rneasy mini kit (qiagene, gmbh, germany) according to the manufacturer's instructions. the rna was converted to full-length cdna using reverse transcriptase. the rt mix comprised ae ll of dmpc water, ll of · first strand buffer (invitrogen), ae ll of mm dntp mix (amersham biosciences), ll of mm uni primer, u of rnaguard (amersham biosciences), u of mmlv reverse transcriptase (invitrogen) and ll rna solution in total volume of ll. the reactions were incubated at °c for minutes followed by inactivation of the enzyme at °c for min. pcr amplification with ha and na gene specific primers was performed to amplify the product containing the full length ns gene. twenty-five microliter pcr-mix contained · platinum taq buffer (invitrogen), lm dntp, ae mm mgcl , nm each of fw primer and rw primer, u platinum taq dna polymerase (invitrogen) and ll cdna. reactions were placed in a thermal cycler at °c for min, then cycled times between °c seconds, annealing at °c for seconds, and elongation at °c for seconds and were finally kept at °c until later use. sequences of the purified pcr products were determined using gene specific primers and bigdye terminator version ae chemistry (applied biosystems, foster city, ca), according to the manufacturer's instructions. reactions were run on a abi tm dna analyzer (applied biosystems). sequencing was performed at least twice in each direction. after sequencing, assembly of sequences, removal of low quality sequence data, nucleotide sequence translation into protein sequence, additional multiple sequence alignments, and processing were performed with the bioedit software version ae ae ae with an engine based on the custal w algorithm. the phylogenetic analysis, based on complete gene nucleotide sequences were conducted using molecular evolutionary genetics analysis (mega, version ae ) software using neighbor joining tree inference analysis with the tamura-nei c-model, with bootstrap replications to assign confidence levels to branches. [ ] [ ] [ ] [ ] ha and na sequences obtained from genbank the ha and na gene was analyzed both with selected number of influenza isolates and in comparison with virus genes obtained from genbank were used in phylogenetic studies [ ] . the nucleotide sequence data obtained in this study has been submitted to the genbank database and is available under accession numbers fj , fj ae , fj , fj , gu -gu for ha and fj , fj ae , fj , fj , gu -gu for na. avian influenza prevalence in our study h , h , and h influenza a virus subtypes were found to circulate at the same time, in the same geographic region in the kazakhstan. this finding most likely indicates the existence of a large reservoir of different influenza a viruses in kazakhstan. we analyzed the ha and na gene sequences of the eight influenza a viruses isolated in kazakhstan together with selected number of isolates, reported between year to , and previously published in the genbank. phylogenetic analysis of the h ha gene showed that all viruses separated into the american and eurasian lineages ( figure ). an evolutionary tree suggests that north american isolates have diverged extensively from those circulating in other parts of the world. geographic barriers which determine flyway outlay may prevent the gene pools from extensive mixing. the lack of correlation between date of isolation and evolutionary distance suggests that different h ha genes co circulate in a fashion similar to avian h ha genes and influenza c genes, implying the absence of selective pressure by antibody that would give a significant advantage to antigenic variants. analysis of phylogenetic relationships among the ha ha genes reported in this study clearly shows that viruses belong to the western pacific flyway, one of the major migratory flyways in this region that have subsequently spread throughout eurasia. these findings provide further evidence of the dynamic influenza virus gene pool in this region. along the western pacific migratory flyway, the influenza virus gene pool in the domestic waterfowl of southern china has 'mixed' longitudinally with viruses isolated from japan, mongolia, and siberia. however, it appears that there has also been 'mixing' latitudinally through overlapping migratory flyways, thereby facilitating interaction between the influenza virus gene pool in domestic waterfowl in the eastern and western extremities of the eurasian continent. this helps to explain the latitudinal spread of the qinghai-like (clade ae ) h n virus in the last years, while h n outbreaks in korea and japan may represent the longitudinally transmitting pathway. ha of subtype h so far has been found exclusively in shorebirds, such as gulls, and in a pilot whale (potentially a spillover from shorebirds), but not in other avian species that are natural hosts of influenza a virus, such as ducks and geese; therefore the study of the evolution of these viruses is very interesting. phylogenetic analysis h ha gene revealed three significantly different evolutionary lines: an american line, a european line, and a line comprising the isolates from america and eurasia. further we analyzed na genes of influenza viruses (figure ) . the na gene is important both because of its functional role in promoting the dissemination of the virus during infection, and because, like ha, it is a principal target of the immune system. it was shown that phylogeny of na genes of influenza have the same properties as hemagglutinin. na genes of kazakhstanian viruses belong to eurasian lineage of virus evolution. obtained data are important for surveillance and diagnostics because some of the lpai viruses examined in this study can infect and be shed by chickens and turkeys and may have epidemiology potential during further recombination with other influenza viruses. influenza virus is divided into different subtypes based on hemagglutinin (ha) and neuraminidase (na) on the virus surface. within each subtype, ha continues to mutate and produce immunologically distinct strains, as antigenic drift. the continuous mutation of influenza virus (iv) is important for annual epidemics and occasional pandemics of disease in humans. antigenic drift requires vaccines to be updated to correspond with the dominant epidemic strains. in humans, ivs show both antigenic drift frequently. in contrast, ivs from birds are in evolutionary stasis, and they show little amino acid changes. , the reason is that ivs in bird intestine are not subjected to strong immune selection. hemagglutinin (ha) gene of influenza a virus encodes the major surface antigen, which is the target for the protective neutralizing antibody response that is generated by infection or vaccination. in humans, influenza a viruses show antigenic drift with amino acid changes in the globular head of the ha so as to evade herd immunity of the population. on the contrary, avian influenza a viruses show evolutionary stasis in wild birds. h aivs have occurred frequently in chicken farms in the world. although vaccination is not permitted, h n aivs have circulated in taiwan for a time. the seroprevalence in chicken flocks reaches about % in the field. h n aivs invades internal organs, such as kidney and lung. thus, viruses in chicken flocks are pressured into antibody selection. here, we report that h n aivs in the field have showed evolutional changes instead of evolutional stasis. in response to requests from poultry farmers for diagnostic investigations of illness in poultry flocks, the authors did necropsy at the pen-site. after careful examination, tracheae were taken and kept in cold for virus isolation in the laboratory. for avian influenza virus isolation, trachea was homogenized : in tpb with antibiotics. the homogenate was frozen and thawed three times and then centrifuged at g for minutes. the supernatant was passed through a ae lm filter. the homogenate was examined for the presence of virus by inoculation into five -to -day-old specific-pathogen-free (spf) chicken eggs for two passages. thirteen h n aivs were isolated in this laboratory during and from different parts of taiwan. besides the viruses isolated in this laboratory, the ha sequences of chicken h n aivs were from the genbank. the accession numbers of hemagglutinin of aiv reference strains included in this study were as the following: g ⁄ , dq ; g ⁄ , dq ; ⁄ , dq ; na ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ns ⁄ , dq ; sp ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; pf ⁄ , dq ; pf ⁄ , dq ; pf ⁄ , dq ; a ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ⁄ , dq ; ch ⁄ , dq ; ⁄ , dq ; a ⁄ , dq and ⁄ , dq . the viruses isolated were propagated in the allantoic cavities of -day-old embryonated spf eggs for hour. the virus rna was extracted using qiaamp viral rna miniprep kit (qiagen) . six-week-old balb ⁄ c mice were injected emulsion intraperitoneally with lg of purified and concentrated a ⁄ chicken ⁄ taiwan ⁄ v ⁄ (h n ) virion with complete freund's adjuvant. every two weeks, the mice were boosted supplementary five times with lg of virion in incomplete freund's adjuvant. when the mice were boosted, blood was collected from tail vein and tested by the western blot assay to check the antibody titers. the mice were then injected intraperitoneally with lg of virion at week . five days after the last injection, the splenocytes in the mice were fused with myeloma cells (sp ⁄ -ag ). one week before fusion, the myeloma cell line was expended in dmem medium (hyclone laboratories, logan, ut) with % fetal bovine serum at °c to ensure they were in the exponential growth phase. the spleen cells from immunized mice were washed, harvested, and mixed with the previously prepared myeloma cells and fused by gradually adding % polyethylene glycol- . the resulting pellet was plated into well tissue culture plates. only the fused cells grew in medium with hypoxanthine-aminopterin-thymidine (hat). with fresh medium replacement over weeks, the hybridomas were ready for screening. hightiter monoclonal antibody (mab) preparations were obtained from the ascetic fluid of mice injected with the selected hybridoma clones. the antibody from mouse ascetic fluids was purified by precipitation with ammonium sulfate, then aliquoted and frozen at ) °c, avoiding repeated freezing and thawing. eventually, six mabs were obtained and named ch -d , eb -b , eb -e , eb -f , ff -f , and ff -f , respectively. the hi test was performed following a standard method. all the viruses were diluted twofold and reacted with % chicken erythrocytes in the v-bottomed microtiter plate by the hemagglutination test. after agglutination, four hemagglutinating units of a ⁄ chicken ⁄ taiwan ⁄ v ⁄ (h n ) and ascetic fluids from the immunized mice of the six mabs were prepared for hi test. hi titers of or more were regarded as positive. the cases submitted for diagnosis from chicken farms had respiratory signs, increase in mortality, or drop in egg production (e.g. egg production dropped from % to %). the extent of drop in egg production depended on the chicken ages. for example, the age of case was weeks, a stage of increasing egg production. however, after h n aiv infection, the egg production decreased % instead of increasing and then stayed at % for a week. the infected chickens showed signs of decreasing activity, anorexia from g per bird to g per bird, and respiratory signs. case showed infection in the second floor first and then transmitted to third and fourth floor, indicating that the virus transmitted by air or human movement. however, most cases showed air borne transmission from one flock to another in spite of enforcing restrictions of persons entering the poultry pens and changing clothes and booths. in most cases, males' mortality was higher than that of female pen mates. by comparing the sequences of ha of those h n viruses, we found that amino acid changes in ha were higher than those in ha , showing that antigenic changes on the globular head of ha molecule rather than randomly on the whole ha protein, indicating that h n viruses in taiwan had been selected in the presence of antibody pressure. the aa residues and changes that showed yearly trends were the followings: a- s, i s, v i, n s, e k, l m, e d, q k, a v, or t, s n, s r, k n, y d, n t, s i, g d, l v, i v, g e, t n, g s, a v, k e, d n, i m, and m i. however, their significance on antigenic variation was previously unknown. by hemagglutinination inhibition (hi) assays, except mab ch -d , all other monoclonal antibodies elicited from v ⁄ showed different hi titers with the different h n viruses (table ). however, those mabs showed negative hi to and , the early h n strains. this indicated that the epitopes recognized by those mabs were undergoing antigenic drift. introduction aquatic birds are recognized as the natural reservoirs of the influenza a virus as all known subtypes (h -h , n -n ) have been found in them. phylogenetic analyses of influenza viruses found in other animals revealed that all were directly or indirectly derived from viruses resident in aquatic birds. however, the prevalence, movement, and evolutionary dynamics of influenza viruses in these avian hosts have not been well defined. southern china was hypothesized to be an 'epicenter' for the generation of human pandemic influenza viruses as all major influenza pandemic viruses in the th century emerged from this region. the ecological background that facilitates the occurrence of these pandemic influenza strains has not been fully explored. in the past two decades, four lineages, belonging to h n , h n , and h n viruses, have become established and long-term endemic in different types of poultry in this region. [ ] [ ] [ ] some of these viruses were disseminated to many countries in eurasia and africa and have continued to cause sporadic human infection, posing a persistent pandemic threat to the world. in the mean time, the endemic influenza lineages have undergone extensive genetic reassortment events giving rise to many variants, dramatically increasing the genetic diversity of the influenza virus in this region. questions remain as to how and where these viruses emerged, and what were the sources of the gene segments incorporated within the novel reassortant variants of the h n , h n , and h n virus lineages. to address these questions, surveillance of influenza in migratory and domestic (sentinel) ducks has been conducted since at poyang lake, the biggest fresh-water lake and the major migratory bird aggregation site in southern china. the aim of this study is to identify the prevalence, seasonality, and movement of virus between migratory and domestic ducks. migratory ducks were captured during over-wintering, from november to march. cloacal swabs and blood samples were collected from each individual bird. all birds were released after sampling. to observe the interaction between migratory ducks and domestic birds, we also sampled domestic ducks from two duck farms (designated as sentinel ducks) surrounded by rice fields and inaccessible to other types of poultry, but accessible to migratory birds. that is, the sentinel ducks share the same water body with migratory ducks and have the chance to spread viruses to each other. for sentinel ducks, sampling was conducted fortnightly, all year-round, on the two farms from august onwards. cloacal swabs and fresh fecal droppings were taken. about birds were randomly sampled fortnightly from these farmed ducks. all swabs were soaked in vials containing ae ml transport medium with antibiotics and kept on ice-packs during sampling and immediately stored in ) °c freezers for further use. blood samples from migratory ducks were treated according to methods previously described. serological survey and virus subtyping in migratory and sentinel ducks used hemagglutination inhibition (hi) and neuraminidase inhibition (ni) tests as previously described. for isolates that were not identified by reference antisera, subtypes were determined by rt-pcr using subtype specific ha and na diagnostic primers. prevalence and seasonal patterns of influenza virus in migratory and sentinel ducks during during - a total of cloacal swabs from migratory ducks and cloacal or fecal swabs from sentinel ducks were collected at poyang lake. from these specimens, influenza isolates were obtained from migra- tory ducks and from sentinel ducks; isolation rates of ae % and ae %, respectively (table ) . it was noted in sentinel ducks that virus occurrence formed a seasonal peak from november to february, which completely overlapped the over-wintering months of migratory ducks. this suggests that virus movement or transmission between migratory and sentinel ducks occurred during this period at poyang lake. thirty positive samples (hi titer ‡ ) were identified from blood samples collected during november and december in . among these, samples were positive to h , were positive to h , were positive to h , and were positive to h . one serum sample was positive to both h and h , which suggested co-infection of influenza virus in migratory ducks might occur in natural conditions. poyang lake, which is located in the northeastern part of jiangxi province, is the largest freshwater lake in china and is part of the eastern asia-australia migration route. every year, hundreds of thousands of migratory ducks congregate at poyang lake during the migration season. recent farming practice involves raising domestic waterfowl in dense populations in the poyang lake region. farmraised domestic waterfowl are allowed to feed in and share the same water body with migratory birds, thereby facilitating direct interactions between domestic waterfowl and freeranging migratory birds. this makes poyang lake an ideal site to observe the dynamics of influenza virus interactions between migratory and sentinel ducks in southern china. in our longitudinal surveillance during [ ] [ ] [ ] [ ] [ ] [ ] , the overall virus isolation rate from migratory ducks was less than %, which suggests a low prevalence of viral infection during the birds' southern migration. similar results have been observed in taiwan, which is also an important stopover site for migratory birds along the eastern asia-australia migration route during years of surveillance. the overlap in seasonal patterns of virus infection between migratory and sentinel ducks found in our study suggests that virus movement or transmission between migratory and sentinel ducks occurred during the period of time migratory birds were at poyang lake. the ha subtypes harbored in migratory and sentinel ducks were similar in our study. for migratory ducks, h , h , h were the predominant subtypes, while h , h , and h were the major subtypes in sentinel ducks. hpai h n was only detected from migratory ducks in early on two sampling occasions. from phylogenetic analyses the h n viruses isolated from migratory ducks were closely related to the viruses endemic in domestic poultry in southern china. therefore, it appears that h n viruses endemic in domestic poultry could be transmitted to migratory ducks via close contact in southern china. only lp h viruses were detected from sentinel ducks at poyang lake during this period. whether h n virus infection was absent from sentinel ducks at poyang lake needs further investigation. serological surveys provided further evidence for the prevalence of aiv in migratory ducks at poyang lake. the serological results in did not match well with the epidemiological results during [ ] [ ] [ ] [ ] [ ] [ ] , which suggests that influenza virus infection in migratory birds could be influenced by multiple factors, such as host immune status, population size, spatial and temporal variations, and migration routes. southern china has the biggest domestic duck population in the world. our study demonstrates that dynamic interactions between migratory ducks and sentinel ducks occurred frequently throughout the surveillance period. thus, sentinel ducks could be treated as intermediate hosts between the ''real gene pool'' from migratory ducks and domestic poultry in the whole influenza virus ecosystem. a sentinel duck sampling system may be a feasible method to represent the viruses in the natural gene pool and a baseline for virus or gene interactions between migratory and domestic ducks. further investigations and surveillance are required to better understand the role of the domestic duck population in facilitating virus interactions and the generation of genetic diversity. two distinct lineages of h n influenza viruses represented by a ⁄ chicken ⁄ beijing ⁄ ⁄ (ck ⁄ bei-like) and a ⁄ quail ⁄ hong kong ⁄ g ⁄ (g -like) have become established and endemic in poultry in southern china. these established h n lineages continue evolving to generate many different reassortant variants (or genotypes) , and are causing sporadic cases of human infection. , studies of h n viruses isolated from pigs in hong kong and shandong province have also raised the possibility of reassortment with human-like viruses from pigs. , in addition, h n viruses isolated beyond the late s had preferential binding with a- , -neuacgal human-like receptors. these observations suggest that the h n influenza viruses still have pandemic potential. unlike highly pathogenic h n influenza viruses that have been rarely detected in the live-poultry markets in hong kong since , h n viruses are still frequently isolated in our surveillance program. therefore, we try to understand the continuing evolution of h n viruses through genetic characterization and phylogenetic analyses of the viruses isolated in hong kong live-poultry markets from to . a total of terrestrial poultry were sampled at different live-poultry markets in the hong kong sar between january and december . of those samples, were from chickens and the others were from minor poultry species including chukar, pheasant, guinea fowl, silky chicken, and pigeon. fecal droppings, cloacal and tracheal swabs, drinking water, and environmental samples from cages were collected into transport medium. viruses were isolated in -to -day old embryonated eggs as described previously. virus isolates from positive sampling occasions were selected for sequence analysis. rna extraction, cdna synthesis, and pcr were carried out as described previously. dna sequencing was performed using bigdye terminator v ae cycle sequencing kit on an abi dna analyzer (applied biosystems) following manufacturer's instructions. all sequences were assembled and edited with lasergene ae (dnastar, madison, wi) software. sequence alignment and residue analysis were performed with the bioedit sequence alignment editor, version ae . all eight gene segments of sequenced viruses were characterized and analyzed phylogenetically together with virus sequence data available in public databases. maximum-likelihood trees were constructed using garli ae . estimates of the phylogenies were calculated by performing neighbor-joining bootstrap replicates using paup* ae . systematic surveillance of live-poultry in hong kong from to resulted in h n isolates from samples (overall isolation rate, ae %) ( table ). there were strains isolated from chicken samples (isolation rate, ae %). of these viruses, four were isolated from tracheal swabs (isolation rate, ae %), while isolates were isolated from cloacal or fecal swabs (isolation rate, ae %). an additional isolates were collected from drinking water samples (isolation rate, ae %). there were strains of h n viruses isolated from minor poultry samples (isolation rate, ae %) ( table ) . of these viruses, only one was isolated from tracheal swabs (isolation rate, ae %), whereas strains of viruses were isolated from cloacal or fecal swabs (isolation rate, ae %). the isolation rate in drinking water in minor poultry was again higher when compared with other sampling methods with strains isolated from drinking water samples (isolation rate, %). taken together, these findings suggest that the h n viruses mainly replicated in the intestinal tract of chickens and minor poultry species. also, the high isolation rate in drinking water samples could be a sensitive indicator for monitoring the prevalence of h n viruses in the field. to better understand the evolutionary pathway of h n viruses in southern china, representative viruses, isolated from hong kong live-poultry markets from to , were sequenced and genetically characterized. phylogenetic analysis of the h ha gene revealed that ck ⁄ bei-like viruses were predominant and one chicken isolate had a g -like ha gene ( figure ). this is the first time the g like h ha gene has been detected in chickens from livepoultry markets in hong kong. the ck ⁄ bei-like lineage is further divided into two subgroups as previously described. subgroup is represented by qa ⁄ st ⁄ ⁄ and subgroup is represented by dk ⁄ hk ⁄ y ⁄ . all h n viruses in this study belonged to subgroup of the ck ⁄ bei-like lineage except for the virus with the g -like ha gene. phylogenetic analysis of the na gene also showed a similar evolutionary pattern to the ha gene with all viruses clustered within the ck ⁄ bei-like lineage. these results revealed that ck ⁄ bei-like viruses are predominant in both chickens and minor poultry. all of the pb , pa, np, ns and m genes clustered with those of h n lineage viruses previously prevailing in ter- restrial poultry in southern china. phylogenetic analysis of the pb gene revealed three different lineages; g -like (n = ), ck ⁄ sh ⁄ f ⁄ -like (n = ), and unknown avian (n = ). the sh ⁄ f ⁄ -like lineage (or f ⁄ -like) was previously reported in eastern china and was used previously for vaccine production in an intensive vaccination program. this pb gene lineage was also distinguishable from the ck ⁄ bei-like lineage and its presence in the viral genome may be due to reassortment between the vaccine strain and field isolates, followed by selective establishment in terrestrial poultry. gene constellation analyses of the viruses revealed six genotypes. thirty-four of the viruses analyzed belonged to two genotypes, b and b , which were also the prevailing reassortants found in other provinces in southern china since . the remaining sixteen viruses belonged to four novel genotypes that have not been identified before in this region. characterization of h n influenza viruses isolated from live poultry in hong kong markets from a year surveillance program revealed that ck ⁄ bei-like viruses were predominant in southern china and were continuing to evolve. two recognized and four novel genotypes were identified in this study. one characterized virus, ck ⁄ hk ⁄ nt ⁄ , had a g like ha gene (the first time this has been detected in hong kong poultry markets) that showed a close relationship with two human h n strains isolated in . g -like viruses were usually detected and caused outbreaks in chickens of middle eastern and european countries, [ ] [ ] [ ] and minor poultry, mainly quail, in southern china. whether the g -like virus was transmitted from china to middle eastern and european countries, as the highly pathogenic h n virus did in the last five years, or vice versa, is still unknown. since the ck ⁄ hk ⁄ nt ⁄ strain clustered with other g -like strains isolated previously in minor poultry in southern china, the g -like viruses in chicken may be due to interspecies transmission from minor poultry species. genetic studies demonstrated that reassortants with genotypes b and b persistently occurred in either chickens or other minor poultry species from to . other genotypes that were prevalent in southern china might be being gradually replaced and four novel genotypes were identified in this study. these novel genotypes were generated through reassortment of viruses with different lineages. a newly emerged f ⁄ -like lineage originating from eastern china is responsible for generation of some of the novel genotypes found in this study. the ck ⁄ bei-like lineage is gradually being replaced by f ⁄ -like lineages which are becoming dominant in northern and eastern china. , animal experiments have also demonstrated that f ⁄ -like viruses are more effective in replication and transmission in chickens compared with ck ⁄ bei-like viruses. since the f ⁄ -like lineage of the pb gene has been introduced into southern china, this newly emerged lineage may have a higher tendency to replace the rnp genes in the circulating ck ⁄ bei-like viruses and subsequently become the endemic virus in terrestrial poultry. in vietnam, the modelling of the pandemic h n progression estimates that ( - ) pigs might be exposed to the virus on the basis of cases among swine owners ( - ). a poor level of biosecurity, high animal densities, and a mix of species could increase the risk of influenza virus flow, persistence, and emergence on swine and poultry farms. this study was set up in the red river delta, where a third of the national pig husbandry is produced. the aims are to give preliminary information of the epidemiological state of swine influenza and in order to further assess the risk of infection of swiv, through cross-species transmissions from poultry to pigs. this paper will present the preliminary results on swiv and the risk factors of pig seropositivity in vietnam. a cross-sectional study was conducted in two provinces of the red river delta in april . pig farms were randomly selected from nine communes representative of at risk area of avian h n . in each farm, pig and poultry were sampled and collected to virological and serological analyses. interviews were conducted in all farms by trained interviewees. questionnaires included closed and open questions on ª blackwell publishing ltd, influenza and other respiratory viruses, (suppl. ), - livestock husbandry ⁄ management and household characteristics, such as herd size and structure, health history and vaccination, pig housing, watering and feeding system, reproduction, purchasing of animals, biosecurity measures, pig contact with poultry, and environmental factors. the virological detection assay was performed on pools of nasal swab specimens from pigs. we investigated whether real-time rt-pcr assay could detect gene m on pools of nasal swab specimens before attempting virus isolation from individual nasal swab specimens. the poultry and pig sera were tested against influenza type a with an enzyme-like immunosorbant assay (elisa) competition test idvetª. this commercial kit is designed to specifically detect antibodies directed against the np protein antigen of influenza type a viruses. the positive serum samples were examined in hemagglutination inhibition (hi) to determine antibody titers and subtypes. the hi test was tailored for h , h , and h subtypes in pigs and h and h subtypes in poultry. seroneutralization tests by pseudo particles were used to test the presence of antibodies directed against h subtype. we analysed the data for relationships between influenza a serological status (the outcome variable) and possible risk factors using r version ae ae (r development core team). the statistical unit was the individual. initially, the quantitative variables were encoded into categorical variables according to the quartiles or median. descriptive statistics (e.g., means or medians, proportions, standard deviations) were calculated for all herd-level and commune level predictors to assist in the subsequent modeling process. we also performed the independence test among all variables to determine if variables were dependant. then, univariate analysis of potential risk factors for the pigs being positive for swiv and estimation of odds ratios were performed using generalised linear mixed models with binary outcome and logit link function for each herd-level and commune-level variable to determine which variables were individually associated with influenza a seropositivity at a significance level of p < ae . herd and commune of residence were included as a random effect to account for the correlation of observations at the herd level. the third stage of the analyses included the four herdlevel variables found to be significantly (p < ae ) associated with influenza a seropositivity. an automatic process using all possible associations between the selected variables was computed into a mixed logistic regression models, with random effects. when two variables were collinear, as determined before, only one variable was likely to enter the multivariable model, and therefore, the selection of which collinear variable to enter the model was guided by biological plausibility and statistical significance. all of the pools of nasal swabs were rt-pcr negative. the maximal possible prevalence considering perfect diagnostic tests would be of ae % at a confidence level of %, in an infinite population within these regions (win-episcope ae ). six hundred-and-nine pig sera were tested in nonvaccinating farms. the herd seroprevalence of swine influenza in the commune previously infected by the avian h n in the red river delta raised by ae % [ ae ; ae ] in april . but among seropositive farms, only four had at least two seropositive pigs. the within-herd seroprevalence is very low, and no seropositivity was detected in the majority of farms. estimates had large confidence intervals due to small sample sizes. the individual seroprevalence raised ae % [ ae ; ae ]. the subtyping of seropositive sera is still in process. descriptive statistical analyses on five major risk factors of swiv: farm size, breeding vs. fattening, purchasing, percentage of family income, and poultry production, were conducted. based on this analysis, three types of farming systems were identified and included in mixed models ( table ) . percentage of family income by pig production and poultry production were not differentiating factors for this typology. whereas types and seem to be specialized in fattening, the type produces and might sell piglets on the farm site. the exploration of the different variance components indicated that the random effect variances were mainly associated with the herd, while the commune did not seem to have any effect. therefore we included in all models only the herd as a random effect. the random effect term for herd was modelled, assuming a normal distribution with a table . typology of farming system type : large fattening farms largest scale production, with more than pigs per year specialized in fattening, and purchase more than pigs per year type : small fattening farms small scale of production, with less than pigs per year specialized in fattening, and purchase less than pigs per year type : medium breeding-fattening farms medium scale of production, with less than pigs per year breeding and fattening piglets, with rare purchase common variance [$n( ,r herd)]. the univariate analyses were conducted on variables and typology variables, with herd as random effect. some coefficient or confidence intervals were inconsistent because of small effectives, especially for the percentage of self-product culture or the pig freegrazing because of the lack of positive results in the dataset. the only one significant (p value < ae ) parameter was the percentage of pig sales in the familial annual income. surprisingly, common risk factors of swine influenza infection, such as farm size, animal movements, and sanitary parameters got low odds ratio individually (without being significant); the typology provides the hypothesis of complex interactions effects that increase the risk of infection. as shown in table , the farming system type got a higher seroprevalence of ae % [ ae - ae ] and a higher risk indicator, with or = ae (p-value = ae ) in comparison with type . this finding was not significant. in the multivariate mixed model, the percentage of familial income provided by pig production was the only one significant variable, with or = ae [ ae - ae ]. the focus on diseased animals in the winter-time is usually required in order to increase the likelihood to isolate the virus, although the isolation rate on healthy or clinical samples never exceed %. the season and the lack of disease reports might explain the difficulties to detect influenza viruses. additionally, the pooling method tends to decrease the isolation rate because of a dilution effect, potential presence of pcr assay inhibitors, or uneven distribution of virus in the sample. our seroprevalence results must be confirmed and the subtypes identified, especially because we found only one positive animal in a few farms that could be attributed to false positive results of the elisa test (performances are not known). these preliminary results are in favor of a virus circulation at low level in the spring, but must be completed by further surveys in the winter and before the new year (têt celebration) when pig production, trade, and movement increase at their maximum. no clear prior information on the expected prevalence of swine influenza in vietnam, tests sensitivity, and speci-ficity could be obtained from literature or reliable sources. bayesian methods will be carried out in the future in order to compute prevalence and ⁄ or to estimate the probabilities of freedom. the risk factors analysis was limited by the lack of positive results. further studies are necessary to identify the at-risk season and type of farming systems at risk of swine influenza infection. however, this investigation of risk factors leads to the hypothesis that medium size breeding-fattening farms had a higher risk than large or small size fattening farms. further investigation are needed to precise this typology. the risk of swiv infection increases with a combination of three major factors. poultry production does not seem to play any role on swine infection. the generalized linear mixed model afforded to take into account all the non investigated parameters at the herd level. although we investigated the most common risk factors of swine influenza infection covering different kind of fields, the herd random effect might explain risk variations. mixed models have become a frequently used tool in epidemiology. due to software limitations, random effects are often assumed to be normally distributed. since random effects are not observed, the accuracy of this assumption is difficult to check. further studies, such as case-control or cohort studies could help to identify more precisely risk factors of swine influenza seropositivity, as these study designs are more adapted than cross-sectional studies. the concept that swine are a mixing-vessel for the reassortment of influenza viruses and for the emergence of pandemic influenza viruses has been re-enforced by the emergence of the recent pandemic. the pandemic h n virus of (h n pdm) is believed to have emerged through the reassortment of north american triple reassortant and eurasian avian-like swine influenza viruses. since the immediate precursor of this pandemic virus has not yet been identified, it is not possible to be definite whether the reassortment leading to the pandemic occurred in swine, but swine influenza viruses are the nearest known ancestors of each gene segment of h n pdm. , the mechanisms of pandemic emergence are not clear. it is believed that the pandemics of and arose through reassortment of the pre-existing human seasonal influenza virus with avian influenza viruses, and swine have been proposed to be a possible intermediate host where such reassortment between human and avian viruses may take place. the pandemic was the first to arise for over years and the first to occur after the understanding that pandemics arise from animal influenza viruses. systematic studies of influenza virus ecology and evolution in swine are, therefore, important in order to understand the dynamics of pandemic emergence. furthermore, since swine are the likely host within which h n pdm virus originated, it was predicted that this virus would readily infect swine and may reassort with endemic swine influenza viruses. these predictions have now been confirmed with reports of h n pdm being detected in pigs in many countries and reassortment with endemic swine influenza virus being confirmed. while h n pdm has been genetically and antigenically stable in humans, reassortment between h n pdm, which is well adapted to transmission in humans, and other avian or swine viruses may lead to the origin of novel viruses posing a threat to public health. in addition to endemic swine virus lineages, avian influenza viruses such as h n and highly pathogenic avian influenza (hpai) h n have also been occasionally identified in pigs in parts of asia. , it has been shown that h n pdm readily reassorts with h n to generate viable progeny in vitro. it is therefore essential to monitor the ecology, evolution, and biological characteristics of swine influenza viruses so that their continued evolution and zoonotic and pandemic potential can be monitored. there is however, a paucity of surveillance data on swine influenza viruses worldwide. this is in part related to the negative commercial consequences that may arise from detection of influenza in a swine herd leading to a major economic loss to the producer. here we outline a surveillance system that has been in place in hong kong for the last decade, based on sampling animals arriving at an abattoir in hong kong. we demonstrate the feasibility of such surveillance in an abattoir setting and compare methods used for detection influenza viruses in swine. virus isolation was carried out by inoculation into mdck cells and by allantoic inoculation in embryonated eggs as previously described. virus isolates were subtyped by haemagglutination inhibition tests using specific antisera and genetically characterized by sequencing and phylogenetic analysis of the haemagglutin gene. , virus detection by rt-pcr a subset of recent specimens was tested in parallel by real time pcr using the biorobot universal system (qiagen) that enables fully-automated viral nucleic acid extraction and downstream reaction setup in a -well plate format. total viral nucleic acids were extracted in a -well plate format with the qiaamp virus biorobot mdx kit (qiagen) on the biorobot universal system (qiagen) according to the manufacturer's instructions. briefly, ll of sample was lysed in ll buffer al, supplemented with ae lg carrier rna in a s block (qiagen), which placed the samples into a well plate format. after protease digestion, samples were transferred to silica based membrane in well plate format for binding. following two washing steps, rna was eluted in ll of elution buffer (buffer ave) into a well elution microplate cl (qiagen) . for the synthesis of cdna, ll of purified rna was used in a ll reaction containing ll of · buffer, ae nm of each deoxynucleotide triphosphate (dntp), mm dithiothreitol, lg random primer, u of rnaseout recombinant ribonuclease inhibitor, and u of superscript iii reverse transcriptase (all from invitrogen). reactions were performed in the geneamp thermocycler (applied biosystems) with the following parameters: minutes at °c, minutes at °c, and soak at °c. subsequent to the reactions, ll of cdna was diluted ⁄ by adding ll of ae buffer (qiagen) . real-time pcr was performed using the power sybrÒ green pcr master mix (applied biosystems) according to the manufacturer's instructions. briefly, ll of ⁄ diluted cdna was amplified in a ll reaction containing ae ll of · power sybr green pcr master mix, nm of forward primer m c ( ¢-ctt cta acc gag gtc gaa acg- ¢) and nm of reverse primer m r ( ¢-agg gca ttt tgg aca aag ⁄ t cgt cta- ¢). the primers have been designed to amplify the sequences in the conserved region of influenza a virus matrix gene, thereby detecting viruses from different species including swine influenza viruses. real-time pcr was performed in the abi fast system (applied biosystems) with the following cycling conditions: minutes at °c once, seconds at °c, and minutes at °c for cycles, followed by melting curve analysis with seconds at °c, minutes at °c, and seconds at °c. in each assay, serially diluted plasmids containing the full length m gene cloned from a ⁄ vietnam ⁄ ⁄ (h n ) were included as standards to perform absolute quantification. a manual baseline was set from cycles - and a manual cycle threshold (ct) was set at ae . samples that were positive or unequivocal results from the real-time pcr were confirmed by performing gel electrophoresis on the pcr products. positive visual identification was made in the presence of the target pcr product at bp in length. a total of tracheal and nasal swabs were processed during the years january -april and yielded influenza virus isolates, an overall virus isolation rate of ae %. of these, were subtype h (classical swine, eurasian avian-like swine, and triple-reassortant), were human-like h viruses, and were eurasian avianlike swine h n viruses. culture in mdck cells yielded % of h subtype viruses, % of the human seasonal-like h n viruses, and ae % of the avian-like eurasian swine h n viruses. culture in embryonated eggs yielded ae % of the h subtype viruses, % of the human seasonal-like h n viruses, and ae % of eurasian avian-like swine h n viruses ( figure ). tracheal and nasal swabs each gave comparable overall virus isolation rates ( ae %). however, isolation rates for human-like h n viruses were ae fold higher in nasal swabs ( ae % versus ae % respectively; p = ae ) ( figure ) . a parallel evaluation of rt-pcr and culture was carried out in specimens. rt-pcr detected ⁄ ( %) of the culture positive specimens. rt-pcr was also positive in ⁄ ( ae %) culture negative specimens, but all these specimens had very low virus load in the rt pcr tests. virus could not be cultured from these culture negative specimens even by attempts at virus re-isolation from the frozen specimen. surveillance in an abattoir setting provides an acceptable yield of influenza viruses and is a feasible method of swine influenza surveillance. sampling in a large abattoir setting allows surveillance to be carried out anonymously with no negative consequences to the supplier. the supply-chain of pigs to the hong kong abattoir involves pigs being trucked in over long distances and may provide opportunity for virus amplification during transport. thus, virus isolation rates may be lower in more vertically integrated and homogenous production and slaughter systems where less mixing of pigs occurs. our results indicate that mdck cell culture is essential for optimizing virus isolation during swine influenza surveillance. allantoic inoculation of embryonated eggs by itself is sub-optimal for isolation of swine influenza viruses. it is however possible that inoculation of embryonated eggs by the amniotic route may lead to better isolation rates than allantoic inoculation. rt-pcr detection is an alternative method for virus detection. but the additional specimens detected by rt-pcr did not yield culturable virus, even following attempts at re-isolation and sequential passage. the rt-pcr positive ⁄ virus isolation negative specimens had very low virus load, and this may be the explanation for the inability to isolate such viruses. in addition, rt-pcr did not detect all viruses isolated by culture. tracheal and nasal swabs gave comparable isolation rates with the exception of human-like h n viruses which were more frequently isolated from nasal swabs. this may suggest that, in contrast to endemic swine influenza virus lineages, these human-like h n viruses are less adapted to replication in the lower respiratory tract. in summary, collection of nasal or tracheal swabs in an abattoir setting together with virus isolation in mdck cells provides a feasible approach to surveillance of swine influenza viruses. kong, kong, - introduction wild waterfowl are the natural reservoir of influenza a viruses (aiv), and they play an important role in the genesis of pandemic influenza. it is suggested that the pandemic virus was purely derived from avian virus, which adapted to humans and caused efficient human-to-human transmission, while the pandemics of and had acquired the viral haemagglutinin, pb polymerase, and in , the neuraminidase gene segments from the avian gene pool. the major regional outbreaks of highly pathogenic avian influenza (hpai) h n in asia, europe, and africa highlight the potential role played by migratory waterfowl in disseminating highly pathogenic influenza viruses. therefore defining the influenza virus gene-pool in wild birds is of vital importance. surveillance was carried out - times weekly from to during the winter months of october to april in the hong kong mai po nature reserve and lok ma chau, hong kong. the hong kong mai po nature reserve and lok ma chau are along the east asia-australian flyway where a peak of more than ducks and grebes congregate every winter. fecal droppings were collected and transported in vials containing ae ml of vtm, which was prepared from m ( ae g ⁄ l), penicillin g ( · u ⁄ l), polymyxin b ( · u ⁄ l), gentamicin ( mg ⁄ l), nystatin ( ae · u ⁄ l), ofloxacin hcl ( mg ⁄ l), and sulfamethoxazole ( g ⁄ l). an aliquot of ll from each swab sample was inoculated into the allantoic cavity of a -to -day-old chicken embryonated egg, and incubated for days at °c. positive ha isolates were subtyped using standard antisera , and rt-pcr was performed with the used of one-step rt-pcr assay (invitrogen) described earlier, followed by sequencing on abi prism xl dna analyzer. the determination of species of origin was performed by dna barcoding of the mitochondrial cyto-chrome oxidase i gene from dna extracted from the fecal droppings. during the -year surveillance period, a total of influenza viruses were isolated from samples collected, an overall isolation rate of ae %. a total of isolates were obtained from specimens collected during the winter period coinciding with the southern migration of waterfowl along the east asian flyway and one isolate obtained from samples collected in spring during the period when northern migration of waterfowl took place along the east asian-australasian flyway. the isolation in hong kong was slightly lower than a similar study conducted in south korea in which the isolation rate of migratory birds was ae % in - . this suggested a slightly lower prevalence of influenza virus present in hong kong as the birds migrated southwards. the viruses isolated in hong kong, representing hemagglutinin (ha) subtypes of h -h and neuramidinase (na) subtypes of n -n , were all from wild waterfowl ( table ) . out of the twelve ha subtypes isolated, h and h were the two subtypes that were isolated frequently every year for h and in six out of seven years for h , respectively. h and h viruses accounted for ae % and ae % of all virus isolated, respectively. on the other hand, h , h , and h were the least prevalence ( ae %) and were only isolated once in years. of the na subtypes, n and n were isolated most often ( ae % and ae % of all isolates, respectively) and n was the least ( ae %). november was the month that had the highest prevalence of influenza virus ( ae % of samples being positive) compared to only ae % in march. the subtype's variation was the most diverse in december during our years of surveillance. this suggested that more of these wild migratory birds may be carrying influenza virus when they arrive in hong kong. however the continued isolation of viruses suggests continued circulation of these viruses in the vicinity of mai po. the study of dna barcoding for the mitochondrial cytochrome oxidase i gene retrieved from fecal droppings revealed that the isolates originated mainly ( ae %) from birds of the order anseriform, family anatidae including eurasian wigeon, northern shoveler, northern pintail, common teal, and garganey. non-anseriformes which were found to have shed aiv viruses were cormorant, grey heron, and stint. none of the water samples collected from the ponds where these birds congregate were found to be positive for the virus. phylogenetic analyses of the ha gene of the lpai h viruses isolated in this study clustered with that of the other lpai h viruses isolated from hokkaido, mongolia, and siberia and were not closely related to the hpai h n . satellite tracking of eurasian wigeons and northern pintails in dec and revealed their flyway from hong kong to as far north as eastern russia, eastern mongolia, and northern china. no hpai h n viruses were isolated in this study from apparently healthy birds. however, as part of the surveillance of dead wild birds carried out by the department of agricultural, fisheries and conservation of the government of hong kong during this same period, over dead wild birds were tested positive for hpai h n and has been reported elsewhere. our influenza surveillance in hong kong has revealed a diversity of influenza virus subtypes the migratory waterfowl infected within the region. the result of the phylogenetic analysis correlated with the findings from satellite tracking that viruses isolated in hong kong were closely related to those isolated in areas along the migratory route. no healthy bird was isolated with hpai h n, although dead wild birds have been regularly found to have hpai h n virus, suggesting that infected birds might not live for a long period. introduction a novel swine-origin h n influenza virus emerged in mexico in april and rapidly spread worldwide, causing the first influenza pandemic of the st century. most confirmed human cases of h n ⁄ influenza have been uncomplicated and mild, but the increasing number of cases and affected persons worldwide warrant optimal prevention and treatment measures. today, almost all of the pandemic h n ⁄ viruses tested are resistant to m blockers. therefore, only the neuraminidase (na) inhibitors are currently recommended for treatment of this pandemic influenza. for the control of influenza infection, the clinical use of oseltamivir has increased substantially during the pandemic. to date, the majority of tested clinical isolates have remained susceptible to na inhibitors, oseltamivir and zanamivir, but oseltamivir-resistant variants with h y na mutation (n numbering) have been isolated from individuals taking prophylaxis, from immunocompromised patients, and from a few community clusters. , in view of the high prevalence of oseltamivirresistant seasonal h n influenza viruses in - , the isolation of resistant h n ⁄ viruses without known oseltamivir exposure raised great concern about the transmissibility and fitness of these resistant viruses. here we studied the transmissibility of a closely matched pair of pandemic h n ⁄ clinical isolates, one oseltamivir-sensitive and one resistant, in both direct contact and respiratory droplets routes among ferrets. viral fitness was evaluated by co-infecting a ferret with both the oseltamivir-sensitive and -resistant viruses. the viruses were also characterized by full genome sequencing, susceptibility to na inhibitors, and growth in mdck and mdck-siat cells. oseltamivir-resistant influenza a ⁄ denmark ⁄ ⁄ (h n ) virus (a ⁄ dm ⁄ ⁄ ) was isolated from the throat swab of a patient who had influenza-like symptoms and received post-exposure oseltamivir prophylaxis ( mg once daily). wild-type influenza a ⁄ denmark ⁄ ⁄ (h n ) virus (a ⁄ dm ⁄ ⁄ ) was isolated from a patient in the same cluster of infection as the a ⁄ dm ⁄ ⁄ virus. to assess growth kinetics of viruses, confluent mdck or mdck siat cell monolayers were infected with viruses at a multiplicity of infection (moi) of approximately ae pfu ⁄ cell (single-step) or ae pfu ⁄ cell (multi-step). supernatants were collected every h or h p.i. for time points. a modified fluorometric assay using the fluorogenic substrate ¢-( -methylumbelliferyl)a-d-n-acetylneuraminic acid (munana) was used to determine viral na activity. the drug concentration required to inhibit % of the na enzymatic activity (ic ) was determined by plotting the percent inhibition of na activity as a function of compound concentration calculated in the graphpad prism (la jolla, ca) software from the inhibitor-response curve. na enzyme kinetics were determined by measuring na activity every seconds for minutes under the same conditions as above, when all viruses were standardized to an equivalent dose of ae pfu ⁄ ml. the k m and v max were calculated by fitting the data to the appropriate michaelis-menten equations using nonlinear regression in the graphpad prism software. young adult ferrets ( - months of age) were obtained from the ferret breeding program at st. jude children's research hospital. all ferrets were seronegative for influenza a h n and h n viruses and for influenza b viruses. for transmission studies, the donor ferrets were lightly anesthetized with isoflurane and inoculated intranasally with tcid virus in ae ml sterile pbs . after the donor ferrets were confirmed to shed virus on day p.i., each donor was then housed in the same cage with two naïve direct-contact ferrets. two additional recipient ferrets were placed in an adjacent cage isolated from the donor's cage by a two layers of wire mesh (approximately cm apart) that prevented physical contact but allowed the passage of respiratory droplets. ferret weight and temperature were recorded daily for days. nasal washes were collected from donors and recipients on day , , , , , , , and p.i. by flushing both nostrils with ae ml pbs, and tcid titers were determined in mdck cells. serum samples were collected weeks after virus inoculation, and were tested for seroconvention by hi assay. full genome sequencing revealed that the pair of h n ⁄ viruses differed only at na amino acid position , where the pandemic a ⁄ dm ⁄ ⁄ virus had an h y amino acid mutation caused by a single t-to-c nucleotide substitution at codon . the wild-type a ⁄ dm ⁄ ⁄ was susceptible to oseltamivir carboxylate (mean ic : ae nm), but the a ⁄ dm ⁄ ⁄ carrying the h y na mutation had ic values approximately - times of the wild-type viruses (mean ic : nm). the ic of zanamivir was comparable for both viruses and were uniformly low (mean ic £ ae nm). the h y na mutation confers resistance to oseltamivir carboxylate but did not alter susceptibility to zanamivir. to understand the impact of the h y mutation on the na enzymatic properties, na enzyme kinetics was determined. the na of the oseltamivir-resistant virus had a slightly higher k m (mean = lm) and lower v max (mean = u ⁄ sec) than na of the sensitive virus (k m , mean = lm; vmax, mean = u ⁄ sec). the results suggested that the h y na mutation reduced na affinity for substrate and na catalytic activity, although the function of na was not severely impaired. to further evaluate the impact of the h y na mutation on virus growth in vitro, single-and multi-cycle growth studies of both viruses were performed in mdck and mdck-siat cells. in the both single-and multiple-cycle growth curves, the two viruses reached comparable levels eventually, but the initial growth of the resistant virus was significantly delayed by at least - logs in comparison to that of wild-type virus (p < ae ). the donor ferrets inoculated with wild-type a ⁄ dm ⁄ ⁄ or oseltamivir-resistant virus shed virus productively until day or day p.i., with a peak virus titer comparable to that of a ⁄ dm ⁄ ⁄ virus (table ). in a ⁄ dm ⁄ ⁄ virus group, two of direct-contact ferrets the weight loss in ferrets is the maximum percentage loss compared with the initial weight. virus shedding is indicated as number of virus-shedding animals ⁄ total number; mean peak virus titer (log tcid ⁄ ml) in nasal wash samples is indicated in parentheses. serum hemagglutination inhibition (hi) titer to homologous virus in ferret serum was determined on day p.i. duan et al. and of respiratory droplet-contact ferrets were infected through virus transmission, as indicated by the virus titers and inflammatory cell counts in their nasal washes and also by sero-conversion. under identical conditions, in a ⁄ dm ⁄ ⁄ group, only of direct-contact ferrets were infected through virus transmission, but neither respiratory droplet-contact ferrets was infected, as confirmed by the absence of sero-conversion (table ) . virus shedding in the direct-contact ferrets was lower and peaked after a longer interval in this group than in the oseltamivir-sensitive a ⁄ dm ⁄ ⁄ group (table ) , but the resistant viruses appeared to cause a similar disease course in ferrets without apparent attenuation of clinical signs. these results showed that an oseltamivir-resistant h y mutant of pandemic h n virus, a ⁄ dm ⁄ ⁄ virus could be only transmitted efficiently by direct contact. to compare the relative fitness, growth capability, and transmissibility of the sensitive and resistant h n ⁄ viruses within host, a donor ferret was co-inoculated with a : ratio of the sensitive and resistant viruses, and another two naive ferrets were housed with the donor to test direct contact. during co-infection, the pattern of virus shedding and the clinical signs were similar to those in ferrets inoculated with either a ⁄ dm ⁄ ⁄ or a ⁄ dm ⁄ ⁄ virus (table ). in the inoculated donor ferret, the virus population in the nasal washes remained mixed but wild-type viruses outgrew the resistant virus progressively ( figure ). two of direct-contact ferrets were infected through virus transmission, but only wild-type virus was detected in both direct-contact ferrets ( figure ). in summary, oseltamivir-sensitive a ⁄ dm ⁄ ⁄ virus possessed better growth capability in the upper respiratory tract than did resistant a ⁄ dm ⁄ ⁄ virus, and thus had an advantage in directcontact transmission. our study determined the comparative transmissibility of two naturally circulating oseltamivir-sensitive and -resistant pandemic h n ⁄ viruses; we demonstrated inefficient respiratory-droplet transmission of an oseltamivir-resistant h y mutant of pandemic h n virus among ferrets, although it retained efficient direct-contact transmission. we suggest that the lower fitness of resistant virus within the host along with its reduced na function and delayed growth in vitro may in part explain its less efficient transmission. notably, the h y mutant of h n ⁄ used in this study was the first oseltamivir-resistant h n ⁄ isolate from a patient on oseltamivir prophylaxis to be characterized for transmissibility. our observation in the animal model is consistent with the epidemiological data collected from humans, which showed no evidence of predominant or continued circulation of oseltamivir-resistant viruses. as this study was undertaken, additional h y mutants of h n ⁄ viruses have emerged in the absence of oseltamivir use. , the emergence of these viruses should raise concerns as to whether resistant h n ⁄ viruses will acquire greater fitness and spread worldwide as the naturally resistant h n viruses did during the - season. two independent studies have evaluated the pathogenecity and transmission of other oseltamivir-resistant pandemic h n ⁄ clinical isolates in the animal models. , one of the studies, which also used an oseltamivir-resistant virus isolated from a patient under oseltamivir prophylaxis, observed similar results as ours: although the respiratory-droplet route of transmission was not investigated, it was shown that the resistant isolate was transmitted though direct-contact route and was as virulent as wild-type virus in ferrets. in another study, two oseltamivir-resistant isolates were transmitted through the respiratory-droplet route in ferrets, and the dynamics of transmission were different between the two isolates. apparently, these two oseltamivir-resistant isolates were still unequal in their transmissibility and were disparate from the resistant isolate in our study. the isolation history of the two resistant isolates was unclear in this study, and this would be an important factor to understand the fitness of drug-resistant viruses. further studies with more clinical isolates of diverse isolation background are warranted to identify how these novel h y mutants of pandemic h n ⁄ virus have changed to retain their full transmissibility. taken together, all these related studies underline the necessity of continuous monitoring of drug resistance and characterization of potential evolving viral proteins. this study was supported by contract hhsn c from the national institute of allergy and infectious diseases, national institutes of pigs have been considered as hypothetical ''mixing vessels'' facilitating the genesis of pandemic influenza viruses. , the pandemic h n ⁄ virus (ph n ⁄ ) contained a very unique genetic combination and was thought to be of swine origin, as each of its eight gene segments had been found to be circulating in pig populations for more than a decade. however, such a gene constellation had not been found previously in pig herds all around the world. only after its initial emergence in humans has this virus been repeatedly detected in pigs, and found to further reassort with other swine influenza virus. [ ] [ ] [ ] a primary question remaining to be answered is whether the ph n ⁄ -like and their genetically related viruses could become established in pig populations, thereby posing novel threats to public health. despite the fact that ph n ⁄ first appeared in mexico and the united states, and six of its eight gene segments were derived from the established north american triple reassortant swine influenza virus (trig), its neuraminidase (na) and matrix protein (m) genes belonged to the eurasian avian-like swine lineage (ea), which had never been detected in north america previously. , likewise, the trig-like viruses were never reported in europe. in contrast, both lineages of virus were frequently detected in asia, and reassortants between them have also been documented in recent years. , this has given rise to a complicated ecological situation, i.e. the simultaneous prevalence of multiple genotypes of h n and h n viruses in pigs. , among them, two representative reassortants showed the most similar genotypic characterization to the ph n ⁄ virus, the sw ⁄ hk ⁄ ⁄ (h n ) and sw ⁄ hk ⁄ ⁄ (h n ), which respectively harbor seven and six gene segments closely related to the pandemic strains. , to understand their in vivo characteristics and zoonotic potential, these two viruses, together with a human prototype strain and a swine ph n ⁄ -like isolate, were chosen for a study of their pathogenicity and transmissibility in domestic pigs, ferrets, and mice. the prototype ph n ⁄ virus, a ⁄ california ⁄ ⁄ (ca ), was provided by the world health organization collaborating centers for reference and research on influenza (atlanta, ga, usa). three ph n ⁄ -related swine influenza viruses were isolated through our surveillance program in south china as previously described. , the a ⁄ swine ⁄ guangdong ⁄ ⁄ (h n , gd ) virus was a ph n ⁄ -like swine isolate. a ⁄ swine ⁄ hong kong ⁄ ⁄ (h n , hk ), the closest pandemic ancestor known to date, possesses an m gene derived from the ea lineage, with the other gene segments from trig viruses. a ⁄ swine ⁄ hong kong ⁄ ⁄ (h n , hk ), a recent pandemic reassortant progeny, had a ph n ⁄ like na gene (also belonging to the ea lineage), an ea-like hemagglutinin (ha) gene, and six trig-like internal genes. all viruses were propagated in madin-darby canine kidney (mdck) cells for three passages, and their titers were determined by plaque assays. all experiments with live viruses were conducted in biosafety level (bsl- ) containment laboratories. pigs ( - week old, n = - ) and ferrets ( month old, male, n = ) were intranasally infected with pfu of each virus, and mice ( ) ( ) week old, female balb ⁄ c, n = ) with a dose of pfu. naïve uninfected pigs (n = ) were co-housed in the same cage with the inoculated ones from each group. body weights and clinical signs were recorded daily. virus replication was determined by titration of the virus in nasal and rectal swabs (pigs), nasal washes (ferrets), as well as from lungs and other organs (pigs and mice). seroconversion was tested by hemagglutination inhibition (hi) assays. histopathological and immunohistochemical analysis were performed as previously described. statistical analysis was performed by mean analysis with pasw statistics (spss inc., chicago, il, usa). the probability of a significant difference was computed using anova (analysis of variance). results were considered significant at p < ae . the pathogenicity of the four viruses tested differed significantly in inoculated mice. animals infected with pfu of hk experienced the most severe body weight loss ( ae ± ae %) but started to recover after days post-infection (dpi). hk caused similar peak body weight loss ( ae ± ae % on dpi) in mice as did ca ( ae ± ae %, on dpi), but the onset of clinical signs and weight loss (on dpi) was day later than those caused by the other three viruses. the gd -infected group suffered the least body weight loss ( ae ± ae %, dpi) and was the earliest to recover. although all four viruses were detected in the lungs with comparable virus titers on dpi (p > ae ), mice inoculated with gd consistently showed the lowest lung index (lung weight ⁄ body weight, %) on , , and dpi (p < ae ), suggesting the slightest injury and consolidation of the lungs. in concordance with the body weight change, the lung index from the hk group was higher than that from any other groups on and dpi, indicating the marked virulence of hk in mice. notably, virus titer of hk in the nasal turbinate was lower than the other groups both on and dpi (p < ae ), but virus replication in the lower respiratory tract was either higher (in the trachea) or similar (in the lungs). observations of the body weight changes caused by infection of ph n ⁄ or its genetically related swine viruses in ferrets have come to a similar conclusion as that for the mouse experiment. after nasal inoculation with pfu of each virus, all groups of ferrets experienced transient body weight loss for - days, except for those infected with gd , which showed no significant weight loss (p > ae ). although ferrets from the ca -infected group reached their peak weight loss ( ae ± ae %, dpi) one day earlier than those from the hk and hk groups, they began to regain body weight quickly thereafter. hk -infected ferrets also recovered rapidly and their body weights reached the same level as those of the gd -infected group at dpi. comparatively, ferrets inoculated with hk had the most retarded body weight recovery, which did not get back to the baseline level until dpi. hk was only detectable in the nasal wash on dpi, whereas the duration of virus shedding for gd , hk , and ca was - days. by combining the data obtained from the virus titration in the mouse turbinate and ferret nasal washes, a possible conclusion can be made that hk may have lower transmissibility than the other three viruses. after inoculation or exposure by direct contact (physical contact) with the ph n ⁄ virus and its close relatives, most pigs experience no or mild symptoms, such as slight loss of appetite and inactivity. body weight loss was only recorded in pigs inoculated with hk during the second week post-inoculation, but not in their contact pigs or in the other groups. diarrhea was observed intermittently in each of the inoculated or contact groups throughout the experiment, and viruses could be recovered in the rectal swabs, saliva, drinking water, and environmental swabs (inner cage walls accessible to the pigs) at various time points. however, virus titers in the positive rectal swabs were just slightly above the detection limit, while those from the environment sometimes could be higher. whether these viruses can replicate in the digestive tract or were just carried-over by contaminated foods and water requires further investigation. although virus could be detected in the nasal swabs of all infected or contact animals, the lowest peak titer was from pigs inoculated or in contact with hk ( ae - ae log tcid ⁄ ml lower than the other groups), suggesting unfavorable replication in the nasal cavity for this virus. postmortem examination on and dpi revealed that pigs infected with hk had the most extensive gross lesions in the lungs, and histochemical staining of viral nucleoprotein (np) in lung tissues on dpi also suggested the best replication for hk in the lower respiratory tract. on days post-contact (dpc), all pigs exposed to the inoculated animals developed sero-conversions (hi = - ) except for one from the gd contact group. however, on dpc, its hi titer reached , indicating slower seroconversion. this study revealed that both the pandemic h n and its genetically related swine viruses could readily infect mice, ferrets, and pigs causing mild to moderate clinical symptoms. they could also transmit efficiently between pigs. when compared with the pandemic stains and its reassortant progeny (hk ), the hk (h n ) virus containing the ea-like m gene in the genetic context of the trig virus showed consistently higher virulence in all three mammalian models tested, but it is still unknown what might happen if such a virus further reassorts to obtain the pandemic-like or ea-like na gene. however, our findings suggest that pigs could likely maintain the prevalence of different genotypes of pandemic-related influenza viruses, and highlight the zoonotic potential of multiple strains of swine influenza virus. pandemic influenza viruses emerge from the animal reservoirs. among the three pandemics that occurred in the last century, we learned that the h n and the h n pandemic viruses emerged by reassortment between circulating human virus and avian-origin influenza virus(es). studies on the emergence of the catastrophic spanish h n virus suggest that the virus may have obtained all of its eight gene segments from the avian reservoir, , or alternatively is a reassortant between mammalian and a previously circulating human influenza virus. over years since the last pandemic, the first pandemic in the st century arose in and was caused by a swine-origin influenza virus containing a unique gene combination, with gene segments derived from the circulating north america ''triple reassortant'' (pb , pb , pa, ha, np, and ns) and the ''eurasian'' (na and m) swine influenza viruses. , analysis of the pandemic h n viruses failed to identify known molecular markers predictive of adaptation to humans. the ''triple reassortant'' swine influenza viruses emerged in late s in north america is a reassortant between classical swine (descendent of the virus after adaptation in swine population), avian, and human influenza viruses. the eurasian influenza virus was originally an avian influenza virus that was introduced into the european swine population in the late s. , while incidents of zoonotic infection with triple reassortant or eurasian influenza in humans have been reported, , sustained human-to-human transmission has never been established. these results suggest that the unique gene combination seen with the pandemic h n viruses may confer its transmissibility among humans. we have carried out systematic prospective surveillance of swine influenza in southern china over that last years through samples routinely collected at an abattoir in hong kong. during this time, the surveillance results suggest co-circulation of classical swine h n , triple reassortant h n , eurasian swine h n , and a range of reassortants between these three virus lineages. , ferrets have been reported as a suitable model for the study of influenza transmission as they are naturally susceptible to influenza infection, exhibit similar clinical signs (including sneezing), and possess receptor distribution in the airway similar to that of humans. [ ] [ ] [ ] to identify molecular determinants that enable sustained human-to-human transmission, we compared the pandemic virus with genetically related swine influenza viruses obtained from this surveillance program for their ability to transmit from ferret to ferret by direct contact or aerosol transmission. viruses human h n influenza virus [a ⁄ wuhan ⁄ ⁄ (wuhan )] and pandemic h n influenza viruses [a ⁄ california ⁄ ⁄ (ca )] were included for the study. swine influenza viruses that are genetically related with the pandemic h n virus were selected from our surveillance system, including classical swine-like influenza virus a ⁄ sw ⁄ hk ⁄ ⁄ (h n ) (swhk ), triple reassortant-like a ⁄ sw ⁄ arkansas ⁄ ⁄ (h n ) (swar ), and one reassortant between triple reassortant and eurasia swine influenza viruses [a ⁄ sw ⁄ hk ⁄ ⁄ (h n ) (swhk )]. swhk contains seven gene segments (pb ,pb ,pa,ha,np,m,ns) closely related to the pandemic h n viruses. transmissibility was tested in -to -month-old male ferrets obtained from triple f farm (sayre, pa); all ferrets were tested to have hi titer £ against human seasonal influenza h n (a ⁄ tennessee ⁄ ⁄ ), h n (a ⁄ brisbane ⁄ ⁄ ), and influenza b (b ⁄ florida ⁄ ⁄ ) prior the experiments. in each virus group, three ferrets were inoculated with tcid of the virus. at day postinoculation (dpi), we introduced one naïve direct contact ferret to share the cage with inoculated ferret, and one naïve aerosol contact ferret into the adjacent compartment of the cage separated by a double-layered perforated divider. nasal washes were collected every other day and tested for influenza virus antigen and to determine viral titers (tcid ). weight changes, temperature, and clinical signs were monitored daily. transmission is defined by detection of virus from nasal washes and ⁄ or by seroconversion (> fold rise in the post-sera collected after - days post contact). experiments were performed in the p + laboratory at st. jude children's research hospital. all studies were conducted under applicable laws and guidelines and after approval from the st. jude children's research hospital animal care and use committee. at tcid inoculation dose, all viruses replicated efficiently in the ferret upper respiratory tract with peak titers detected from inoculated ferrets at dpi. lower peak titers were detected from swhk and swhk inoculated ferrets, however, the differences were not statistically significant (table ) . tissues collected from inoculated ferrets at dpi showed that pandemic h n and swine influenza viruses replicated both in the upper and lower respiratory tract of the ferrets, while the replication of human seasonal influenza wuhan was restricted in the upper respiratory tract. direct contact transmission from inoculated donor ferrets to their cage-mates was observed for all viruses studied, albeit at different efficiency. human seasonal influenza (wuhan ) and pandemic h n viruses (ca ) transmitted most efficiently via direct contact route as the virus can be detected on dpi from direct contact ferrets, and the peak titers were detected on dpi from direct contacts. moderate direct contact transmission efficiency was detected from swar and swhk viruses as the virus can be detected from direct contact ferrets at dpi, with peak titers detected at dpi or dpi. classical swine-like swhk showed least efficient contact transmission as virus could be detected from all direct contacts only at dpi, and the peak titer detected on dpi. aerosol transmission was detected in groups of human seasonal influenza virus wuhan ( ⁄ ), pandemic h n influenza virus ca ( ⁄ ), as well as swine precursor virus swhk ( ⁄ ). transmission of wuhan and ca to aerosol contacts was detected at dpi or dpi, while transmission of swhk was detected later at dpi, suggesting that the swhk virus possessed aerosol transmission potential, but may require further adaptation to acquire efficient aerosol transmissibility. in addition to viral detection from nasal washes, we also detected viruses from the rectal swabs of ferrets inoculated or infected with pandemic h n viruses (ca ) or classical swine-like virus (swhk ), which share the common origin for the ha, np, and ns gene segments. while many of the swine influenza viruses studied were able to transmit via the direct contact route, swhk , which shares a common genetic derivation for seven genes with h n pdm, possessed capacity for aerosol transmission, albeit of moderate efficiency. swhk differed from swine triple reassortant viruses in the origins of its m gene. it is possible that the m gene derived from eurasian avian- like swine viruses also contributes to the transmissibility of h n pdm influenza viruses. outbreaks of highly pathogenic avian influenza (hpai) of the h n subtype are of extreme concern to global health organisations as human infection can result in severe acute respiratory distress syndrome, multi-organ failure, and coma. hpai viruses of either h or h subtypes contain a characteristic multi-basic cleavage site in the hemagglutinin glycoprotein as well as other virulence factors that expand the viral tropism beyond the respiratory tract of poultry. there is also emerging evidence of viral rna or antigen in multiple organs and the cns of humans infected with h n that is consistent with systemic infection , and raises the question of the role of the cleavage site in dissemination of the virus in this species. the majority of human cases with h n have involved contact with sick or contaminated poultry and exposure to respiratory secretions of birds that can be inhaled and ingested. particular risk factors for h n infection include bathing with sick birds, improper hand washing after handling sick birds, or slaughtering poultry. viral inoculum may also be consumed directly during a variety of religious and cultural practices, such as drinking contaminated duck blood and kissing of merit release birds. h n infection is lethal in % of human cases, and the pathogenetic mechanisms leading to this level of mortality are unclear. to date cases have been reported to the who, although many more people have potentially been exposed to h n through contact with infected bird populations. some studies have suggested that genetic factors may predispose an individual to severe h n disease, but little is known about the influence of route of virus exposure on morbidity and mortality. in ferrets, an animal model frequently used to study influenza because of its similar disease profile to humans, swayne et al. observed that exposure to a virulent h n strain a ⁄ vietnam ⁄ ⁄ by intra-gastric gavage did not lead to disease and did not generate an antibody response, whereas ferrets that experienced a more natural exposure by being fed contaminated meat developed severe signs of infection. in this study we further assessed the disease profile of h n following a natural oral exposure in the ferret model. to achieve this inoculation condition, conscious ferrets voluntarily consumed a liquid inoculum of h n hpai strain a ⁄ vietnam ⁄ ⁄ . as a comparison anesthetised ferrets were exposed by intranasal administration of inoculum and the ensuing disease profiles of the different routes of infection were compared. eight ferrets per group were inoculated with egg infectious dose of a ⁄ vietnam ⁄ ⁄ in a volume of ll that was given to the nares of anaesthetized ferrets to establish a total respiratory tract (trt) infection or voluntarily consumed by conscious ferrets to establish an oral infection. ferrets were culled at a predetermined humane endpoint that was defined as either a > % weight loss and ⁄ or evidence of neurological signs, discussed in ; animals that did not reach the humane endpoint were euthanased on day after challenge. nasal washes and oral swabs collected during the course of infection and organ homogenates were assessed for the presence of replicating virus by growth in embryonated-chicken eggs; viral loads were determined by titration on vero cells and expressed as tcid . tissue samples were fixed with formalin and embedded in paraffin for sectioning. viral lesions were identified by hematoxylin and eosin staining of the sections and the presence of viral antigen in the sections was determined by staining with antibody to influenza a nucleoprotein. pre-and post-exposure antibody responses were assessed by hemagglutination-inhibition assays using irradiated a ⁄ vietnam ⁄ ⁄ virus. the majority ( %) of ferrets infected by the trt route rapidly became inactive, developed severe disease, and were euthanased at the humane endpoint following infection ( figure ). ferrets infected orally had an improved chance of survival, as only % of animals developed severe disease (figure ), and the surviving ferrets were more active than ferrets infected by the trt throughout the stage of acute infection (data not shown). the improved survival rate and wellbeing of ferrets infected orally was not a result of poor infection rates by this route, as of surviving ferrets developed h specific antibodies by day post-infection, and they did not have pre-existing antibodies to h n (data not shown). the two ferrets that developed severe disease after oral infection had similar disease profiles to ferrets infected by the trt route; they both progressed to a > % weight loss and exhibited neurological signs (data not shown). viral loads in organs of these two ferrets confirmed dissemination to extra-pulmonary sites (table ) : replicating virus was detected at high titres in the spleen, pancreas, liver, and brain. similar findings were recorded in ferrets with trt infections in this study (not shown) and elsewhere. viral load in nasal washes and oral swabs taken at days , , and post-infection by the oral route did not correlate with the development of severe disease, and virus was isolated only sporadically and at low titre from the nasopharynx of these animals (data not shown). interestingly, the two ferrets with severe disease after being infected orally had no detectable viral antigen or lesions in the olfactory epithelium and bulb (table ) , whereas of ferrets culled after infection by the trt route had lesions and viral antigen in both the olfactory epithelium and bulb (data not shown). trt oral figure . percentage of ferrets that survived infection after oral or trt infection. ferrets were exposed to a ⁄ vietnam ⁄ ⁄ by the total respiratory tract (trt) route (circles) or the oral route (triangles). the percentages of ferrets that survived infection are indicated at each day following challenge. ferrets exposed orally were more likely to survive h n infection than ferrets exposed to the same dose of virus by the trt. the improved survival rates that were observed after an oral infection could be a consequence of low-level viral replication in the upper respiratory tract in combination with delivery of a substantial portion of the inoculum directly to the stomach where it may have been inactivated by the harsh environment of the gastro-intestinal tract. most ferrets infected orally developed an h -specific antibody response which differs from the studies of swayne et al. in which ferrets gavaged with a liquid inoculum neither developed signs of disease nor an antibody response. however swayne et al. administered virus to anaesthetized ferrets by gastric gavage that would have bypassed the oropharynx. in our study virus was administered to the oral cavity directly and would have had access to the oropharynx. low level of replication at this site may have been sufficient to trigger an antibody response. the two ferrets that developed severe disease following oral infection had a similar profile of viral dissemination as ferrets infected by the trt route. differences were seen in the olfactory epithelium and bulb as lesions, and viral antigen did not occur in these sites following oral infection, although cerebral involvement was identified. one route of dissemination of h n into the cns may be by transport within nerves through the olfactory bulb into the cerebrum. due to the absence of lesions and antigen in these sites following oral infection the spread of virus into the brain in these two animals may be occurring through involvement of other cranial nerves or the hematagenous routes. nasal turbinates ) ae ) ) ) ) pharyngeal lymph node interactions of oseltamivir-sensitive and -resistant highly pathogenic h n influenza viruses in a ferret model < ae b ) + + + + olfactory epithelium nd a nd ) ) ) ) olfactory bulb nd nd ) ) ) ) trachea < ae ) ) nd ) nd lung ) < ae + + ) + spleen ae ) + + ) + small intestine ) ) ) ) ) + pancreas ) ae + ) + + the pandemic potential of highly pathogenic h n influenza viruses remains a serious public health concern. while the neuraminidase (na) inhibitors are currently our first treatment option, the possibility of the emergence of virulent and transmissible drug-resistant h n variants has important implications. clinically derived drug-resistant viruses have carried mutations that are na subtype-specific and differ with the na inhibitor used. the most commonly observed mutations are h y and n s in the influenza a n na subtype (n numbering here and throughout the text); e a ⁄ g ⁄ d ⁄ v and r k in the n na subtype; and r k and d n in influenza b viruses. h n influenza viruses isolated from untreated patients are susceptible to the na inhibitors oseltamivir and zanamivir, although oseltamivir-resistant variants with the h y na mutation have been reported in five patients after , or before drug treatment; and the isolation of two oseltamivir-resistant h n viruses with n s na mutation from an egyptian girl and her uncle after oseltamivir treatment were described. the impact of drug resistance would depend on the fitness (i.e., infectivity in vitro, virulence, and transmissibility in vivo) of the drug-resistant virus. if the resistance mutation only modestly reduces the virus' biological fitness and does not impair its replication efficiency and transmissibility, the effectiveness of antiviral treatment can be significantly impaired. the recombinant wild-type h n influenza a ⁄ vietnam ⁄ ⁄ (vn-wt), a ⁄ turkey ⁄ ⁄ (tk-wt) viruses, and oseltamivir-resistant viruses with h y na mutation (vn-h y and tk-h y) were generated by using the -plasmid reverse genetics system. susceptibility to na inhibitors was tested by using a fluorescence-based na enzyme inhibition assay with munana substrate at a final concentration of lm. viral fitness was studied in vivo in a ferret model: groups of three ferrets were lightly anesthetized with isoflurane and inoculated intranasally with vn-wt, vn-h y, or mixtures of the two at a different ratios at a dose of pfu in ae ml pbs; they were inoculated with tk-wt, tk-h y, or mixtures of the two at a different ratios at a dose of pfu in ae ml pbs. respiratory signs (labored breezing, sneezing, wheezing, and nasal discharge), neurologic signs (hind-limb paresis, ataxia, torticollis, and tremor), relative inactivity index, weight, and body temperature were recorded daily. virus replication in the upper respiratory tract (urt) was determined on days , , and p.i. the competitive fitness (i.e., co-inoculation of ferrets with different ratios of oseltamivir-resistant and -sensitive h n viruses) was evaluated by the proportion of clones in day- nasal washes that contained the h y na mutation. na mutations were analyzed by sequence analysis of individual clones ($ clones ⁄ sample) created by ligation of purified pcr products extracted from nasal wash samples into a topo vector. introduction of the h y na mutation conferred high resistance to oseltamivir carboxylate in vitro; the mean ic of the vn-h y and tk-h y viruses was and times, respectively, that of the corresponding wildtype viruses. the oseltamivir ic of the tk-wt virus was $ times that of the vn-wt virus. all four recombinant h n viruses were susceptible to zanamivir. introduction of the h y na mutation reduced $ % and % of the na activity of vn-h y and tk-h y viruses, respectively, as compared to the wild-type virus activity (p < ae ; two-tailed t-test). all ferrets inoculated with either vn-wt or vn-h y virus exhibited acute disease signs (high fever, marked weight loss, anorexia, extreme lethargy), rapid progression, and death by day - p.i., and no differences in clinical signs and replication in the urt of ferrets were observed between wild-type and oseltamivir-resistant viruses ( table ) . both of the tk viruses caused milder illness than did the vn viruses, despite a much higher dose ( pfu ⁄ ferret), and the tk-h y virus caused less weight loss and fever than the tk-wt virus (table ) . however, competitive fitness experiments revealed a disparity in the growth capacity of vn-h y and tk-h y viruses as compared to their wild-type counterparts: clonal analysis established the uncompromised fitness of vn-h y virus and the impaired fitness of tk-h y virus (table ) . although, the trend towards an increase ⁄decrease in the frequency of the h y na mutation relative to the wild-type was statistically significant (p > ae ) for two studied groups only. mutations within the na catalytic (r k) and framework (e a ⁄ k, i l, h l, n s) sites or near the na active enzyme site (v i, i t ⁄ v, q h, k n, a t) emerged spontaneously (without drug pressure) in both pairs of viruses (results not shown). the na substitutions i v and e a could exert compensatory effect on the fitness of vn-h y and tk-h y viruses. the lethality and continuing circulation of h n influenza viruses warrants an urgent search for an optimal therapy. our results showed that the h y na mutation affects the fitness of two h n influenza viruses differently: the oseltamivir-resistant a ⁄ vietnam ⁄ ⁄ -like virus outgrew its wild-type counterpart, while the oseltamivir-resistant a ⁄ turkey ⁄ ⁄ -like virus showed less fitness than its wild-type counterpart. we used a novel approach to compare the fitness of oseltamivir-sensitive and -resistant influenza viruses that included analysis of virus-virus interactions within the host (competitive fitness) during co-infection with these viruses. although mixed populations were present in the urt of ferrets on day p.i., the fitness of vn-h y virus was uncompromised as compared to that of its drug-sensitive counterpart, while that of tk-h y virus was impaired. a minor population of na inhibitor-resistant variants may gain a replication advantage under suboptimal therapy in two ways: (i) preexisting variants less sensitive to the drug are selected from the quasispecies population, leading to an increase of the number of resistant clones, and (ii) outgrowing variants may acquire additional compensatory mutations that enhance their fitness. it is possible that use of antiviral drugs (particularly at suboptimal concentration) against mixtures of oseltamivir-resistant and sensitive viruses will promote the spread of drug-resistant variants * ferrets in all groups inoculated with a ⁄ vietnam ⁄ ⁄ virus died by day - p.i. and were observed once daily for days. ** results obtained from one ferret. *** by inhibiting drug-sensitive variants that are competing with them for the dominance in the infected host. the influence of multiple genes on the fitness of viruses carrying h na mutation cannot be excluded. in our study we focused on additional na mutations, and sequence analysis of individual na clones was done to identify potential host-dependent and compensatory na mutations. we found that the na mutations e a and n s, which confer cross-resistance to oseltamivir and zanamivir, , can emerge spontaneously in clade . h n influenza virus in ferrets. further, we observed that mutations at na catalytic (r k) and framework (i l and n s) sites and in close proximity to the na enzyme active site (v i, i t ⁄ v, q h, k n, a t) emerged without drug pressure in both pairs of h n viruses. compensatory mutations in na or other genes may mitigate any fitness cost imposed by resistance mutations. our study identified six potential compensatory na changes (d v, f s, i v, e a, h l, and f s) that may affect the fitness of viruses with the h y na mutation. we suggest that na mutations at residues i v and e a are of importance. interestingly, we observed differences in predominance of i v and e a na mutations in different genetic backgrounds: i v mutation was identified in a ⁄ vietnam ⁄ ⁄ (h n )-like and e a in a ⁄ turkey ⁄ ⁄ (h n )-like genetic background. moreover, i v na mutation was identified only when ferrets were inoculated with the mixtures of vn-wt and vn-h y viruses, but not in ferrets inoculated with vn-h y virus. none of the potential compensatory na mutations was identified in the original inoculum used to infect ferrets. the h y na mutation causes a large shift in the position of the side chain of the neighboring e residue, which must form a salt bridge with r to accommodate the large hydrophobic pentyl ether group of oseltamivir. residue i is located near the na active site, and although it does not alter polarity, it results in a shorter side-chain and, thus, may indirectly affect the residues in the na active site. we suggest that antigenic and genetic diversity, virulence, the degree of na functional loss, and differences in host immune response and genetic background can contribute to the observed differences in the fitness of h n influenza viruses. therefore, the risk of emergence of drugresistant influenza viruses with uncompromised fitness should be monitored closely and considered in pandemic planning. this study was supported by contract hhsn c from the national institute of allergy and infectious diseases, national institutes of health, and by the american lebanese syrian associated charities (alsac). the data presented in the manuscript have been published at: govorkova ea, ilyushina na, marathe bm, mcclaren laninamivir (r- ) is a strong na inhibitor against various influenza viruses, including oseltamivir-resistant viruses. [ ] [ ] [ ] [ ] [ ] [ ] we discovered a single intranasal administration of laninamivir octanoate (cs- ), a prodrug of laninamivir, showed a superior anti-virus efficacy in mouse and ferret infection models compared to repeated administra-tion of oseltamivir and zanamivir. [ ] [ ] [ ] this suggested that cs- works as a novel long-acting na inhibitor of influenza virus in vivo. a single inhalation of cs- proved noninferiority in adult patients and significantly superior in child patients, compared to an approved dosage regimen of oseltamivir for treatment. cs- has been commercially available as an inhaled drug, inavir Ò , for the treatment of influenza in japan since october . the long-acting characteristics of cs- are explained by several reasons. first, cs- was quickly hydrolyzed to an active metabolite, laninamivir, after an intranasal administration to mice, and was retained for a long time as laninamivir in target organs, such as lung and trachea. however, with an intranasal administration of laninamivir, it disappeared quickly and did not demonstrate its longlasting characteristics. another reason is a strong binding of laninamivir to nas of seasonal influenza viruses compared to other three na inhibitors, oseltamivir carboxylate, zanamivir, and peramivir. in the following, the tight-binding ability of laninamivir to pandemic (h n ) na, as well as to the seasonal influenza virus nas, was demonstrated. in addition, we present a hypothesis of the mechanism of the long-lasting property of cs- in mouse based on a localization of an enzyme that hydrolyzes cs- to laninamivir. the influenza viruses, pandemic(h n ) (inf ), a ⁄ new caledonia ⁄ ⁄ (h n ), a ⁄ panama ⁄ ⁄ (h n ), and b ⁄ mie ⁄ ⁄ were treated with excess na inhibitors, such as oseltamivir carboxylate, zanamivir, peramivir, and laninamivir, and then unbound na inhibitors were removed from the mixtures with a bio-spin column bio-gel p- (bio-rad laboratories, hercules, ca, usa). the na substrate, -methylumbelliferyl-n-acetyl-a-d-neuraminic acid (nacalai tesque, japan) was added to the virus-na inhibitor complex, and the na activities were followed for hours at room temperature by measuring the fluorescence at an excitation wavelength of nm and an emission wavelength of nm. the enzyme which hydrolyzes cs- to laninamivir was partially purified from rat lungs using ion exchange column chromatography, and almost all bands separated by an sdspolyacrylamide gel electrophoresis were identified by mass spectrometry. the gene expression profiles of the enzyme were investigated by the bioexpress database (genelogic inc., gaithersburg, md, usa). the enzyme gene cloned from mouse lung mrna was transiently expressed in cos cells. antiserum to the esterase was prepared by immunizing rabbits, and immunostaining was done using histomouse-tm-max kit (invitorgen corp., carlsbad, ca, usa) according to the manufacturer's manual. binding stability of na inhibitors to the four viruses are shown in figure the enzyme that hydrolyzes cs- to laninamivir in rat lungs was identified as carboxyesterase. this esterase was shown to be expressed in epithelial cells of rat lung by in situ hybridization. the mouse homolog of the rat esterase was carboxylesterase (ces ). the mrna of the mouse ces was shown to be highly expressed in lung and liver by the gene expression profile, and ces was also found to contain signal sequences for retention in endoplasmic reticulum (er) and golgi at the c-terminus. the cloned ces gene and the ces gene lacking the signal sequence were exogenously expressed in the cos cells. the cs- -hydrolyzing activity associated with the cos cells expressing ces was recovered from the culture sup of the cos cells expressing ces lacking the retention signal sequence. localization of ces was immunohistologically confirmed inside the airway epithelium cells of mice, which are the target cells for influenza virus infection. the long acting property of intranasal administration of cs- in mice can be explained both by the long retention of laninamivir in the respiratory tract and by the stable binding of laninamivir to influenza virus na. again, stable binding of laninamivir to na of pandemic (h n ) virus was also observed similar to that of seasonal h n virus. the following are speculated as the mechanisms for the long-lasting characteristics of cs- in mice. we explain the mechanism by clarifying a cs- hydrolyzing enzyme and its localization inside cells. the hypothesis of the mechanism is presented in figure . briefly, hydrophilic laninamivir may not enter easily inside cells, whereas hydrophobic cs- may enter inside cells. ces with er ⁄ golgi retention signal hydrolyzes octanoate of cs- figure . difference of binding stabilities of various na inhibitors to influenza virus neuraminidases. the na substrate was added to the influenza virus-na inhibitor complex (oseltamivir carboxylate, n; zanamivir, h; peramivir, s; laninamivir, •; distilled water, ¤), and the na reaction was followed for minutes. the background (only the na substrate [d] ) is also shown. a part of data from. to generate the hydrophilic drug, laninamivir, and then it is trapped inside er ⁄ golgi because of its high hydrophilicity. the glycoprotein, na, which matures in er ⁄ golgi, meets laninamivir there and efficiently makes a stable complex with it. there are some questions that remain. how does cs- move from the cell membrane to er ⁄ golgi? is laninamivir indeed trapped inside er ⁄ golgi, and does it make a complex with na in mice? we are now making an attempt to clarify these concerns. in our study, we have explored the antiviral potential of two newly synthesized compounds to provide protection against the novel pandemic influenza virus h n ( ) strain. the compounds were reconstituted in dimethylsulphoxide (dmso), and so the initial studies began with cytotoxicity determination of solvent on uninfected and untreated madin-darby canine kidney (mdck) cells. on obtaining an upper limit for dmso, the compounds were tested for estimation of their maximum non-toxic dose to the mdck cells. thereafter, the effective dose of the compounds was evaluated and validated by a number of assays and gene expression profiling at both nucleic acid and protein level. we found that these newly synthesized compounds possess potent inhibitory activity towards the novel pandemic influenza h n ( ) virus. these findings are being evaluated in vivo for a better understanding of their inhibitory capabilities and also their effect on the host metabolism. this will be required in the course of development of new drugs for use in the prophylaxis and treatment against the influenza virus. the mdck cell line (from nccs, pune) was maintained in · dmem media (sigma, st. louis, mo, usa) supplemented with % fetal calf serum and antibiotics viz. unit ⁄ ml penicillin and lg ⁄ ml streptomycin at °c ⁄ % co . the synthesized compounds used in this study were kindly provided by the department of chemistry, university of delhi, delhi, india. the pandemic influenza h n ( ) virus was isolated and propagated in the allantoic cavities of embryonated chicken eggs during the pandemic period. the virus stocks were prepared and stored at ) °c. plaque assay was performed as previously described by hui et al., . briefly, ae · mdck cells ⁄ ml were seeded in six-well plates and maintained in dmem for hours at °c ⁄ %co . the monolayer of the cells was inoculated with serially diluted virus samples for minutes at °c ⁄ %co . subsequently, a mixture of agar overlay was added, and the plates were incubated at °c for days or until formation of plaques. the plaques were visualized after removal of the agar plug and staining with ae % crystal violet or neutral red solution. the virus titre was expressed as plaque forming unit (pfu) per milliliter. the in vitro cytotoxicity analysis was performed to determine the % cytotoxic concentration (cc ) of the compounds on mdck cells. the compounds were dissolved in dimethylsulfoxide (dmso), and so a prior cytotoxicity analysis was performed to determine the toxic concentration of dmso on the cells. various concentrations of compounds were mixed with dmem containing % fcs before addition to the preformed monolayer of mdck cells in -well plates. a series of suitable controls for in vitro cc determination was included in every plate, and the plates were incubated in the optimum environment for mdck cell culture. the cc of test compounds was analyzed by estimation of percentage cell viability of the compound-and mocktreated mdck cells by performing a colorimetric assay using tetrazolium salt -( , -dimethylthiazol- -yl)- , diphenyl tetrazolium bromide (mtt) at end-point of hours post-incubation. the assay was performed as described by mosman . briefly, mtt stock at a concentration of ae mg ⁄ ml was prepared in · pbs. the media was aspirated from the wells and ll of mtt dye from the stock was added to each well. following incubation at °c ⁄ % co for - hours, the dye was very carefully removed from the wells, and the cells were incubated with ll of stop solution (dmso) per well at °c ⁄ % co for hour. the absorbance of the supernatants from each well was measured at nm, and the percentage cell viability was calculated. madin-darby canine kidney cells were maintained overnight in a -well tissue culture plate at °c ⁄ % co . the cells were inoculated with various virus dilutions at °c ⁄ % co for minutes and observed for cytopathic effect (cpe). the media from the experimental wells were aspirated after - hours of infection and were subjected to plaque assay. the percentage cell viability was determined by performing mtt assay. the results of both these tests were used to assess tcid of the virus. the pre-formed monolayer of mdck cells was inoculated with the -fold dilution corresponding to tcid of the virus for hour at °c ⁄ co . the experimental setup included control wells for the cells, virus, and compound. meanwhile, the concentrated stocks of the synthesized compounds were diluted with dmem (with % fcs) to various concentrations within their respective cc ranges. one hour post-infection, the cells were incubated with these diluted solutions. the cells were observed at various time intervals post-inoculation for cpe, and ll media was collected from each experimental well for performing hemagglutination test. after h, the media was collected for plaque assay and the cells were subjected to mtt cell viability assay. preformed monolayers of mdck cells were infected with virus and treated with the respective inhibitory concentration of the compounds. forty-eight to hours post-incubation, total cellular rna was isolated using ribozol (amresco, solon, oh, usa) and treated with lg ⁄ ml of dnase (promega, madison, usa). the concentration and quality of the rna from each well were determined by measuring their absorbance at and nm. one microgram of the cdna synthesized from each rna sample was used for sybr green-based real-time pcr detection of the ha gene of pandemic influenza h n ( ) virus. as a control, human glyceraldehyde- -phosphate dehydrogenase (hgapdh) was also amplified using gene specific primers. , immunoblotting immunoblotting was performed to further validate the antiviral potential of the compounds. the experimental protocol was the same as for real time rt-pcr analysis. the cells were harvested hours post-treatment with the compounds to prepare whole cell lysates in mammalian cell lysis buffer [ ae m nacl, ae m tris cl (ph ae ), ae m edta (ph ae ), m m protease inhibitor cocktail, lg ⁄ ml pmsf]. the protein concentration was determined by bca protein assay. the cell lysates were fractionated on % polyacrylamide for western blotting. the blot was developed using sheep monoclonal antibody (santa cruz biotechnology, ca, usa) against ha protein of influenza virus and horseradish peroxide conjugated rabbit-anti sheep igg ( : dilutions) as secondary antibody. the median cytotoxic concentration for compound meuh came out to be lm, and that for flh was lm. compounds showing potent antiviral effect on the pandemic influenza h n ( ) virus propagation in madindarby canine kidney cells ( figure ). the viral titres remained constant in cells treated with the compounds, while they increased in the untreated virus infected cells. ed for the compounds meuh and flh were and lm, respectively. fifty-two percent (meuh) and % (flh) inhibition against the pandemic influenza h n ( ) virus was achieved using ed of the test compounds. both the compounds were able to reduce the rna levels of the ha gene by approximately - %, whereas approximately % inhibition was seen when both the compounds were used in combination. similar results were obtained by the immunoblotting analysis ( figure ). antiviral therapy has shown to be a promising tool in the management of various respiratory diseases, including those caused by influenza viruses. we have already shown inhibition of influenza virus replication in our earlier studies using catalytic nucleic acids, which can be used as an approach in the development of new therapeutic strategy. these therapies are very useful as the influenza virus vaccines need annual renewals due to frequent genetic drifts in the viral surface proteins. in pandemic situations the existing vaccines do not provide complete protection against the novel virus as the population generally remains naïve for the newly mutated surface antigens. the antiviral drugs play an important role in the control of novel viral strains for which there are no vaccines available. however, the key obstruction in the extensive use of antiviral drugs is their cost and relative therapeutic efficacy provided. two classes of drugs were being used for treatment and control of the influenza virus infection in humans, the m ionchannel blockers , (amantadine and rimantadine), which prevent viral uncoating, and the neuraminidase inhibitors , (zanamivir and oseltmivir), which prevent the release of influenza virions from the cytoplasmic membrane. but widespread resistance to these antiviral drugs , has limited their use. thus, novel drugs are required for the effective therapy against the emerging strains of influenza virus. the novel chemical compounds used in our study were tested for their antiviral efficacy against the pandemic influenza h n ( ) virus. a reduction in the cpe in compound treated virus infected mdck cells indicated presence of antiviral activity in chemical compounds. the persistence of constant viral titers in the compound treated cells provided evidence for the interference posed by the compounds in the replication of influenza virus. inhibition in the ha gene expression further validated our hypothesis for the antiviral effect of compounds. the efficacy of these compounds in animal models is currently being validated in our laboratory. further, molecular studies are required to ameliorate the awareness regarding the mode of action of these chemical compounds against the viruses. and is now licensed in japan, while another, laninamivir, is being developed as an inhaled prodrug. resistance to nais among circulating influenza viruses was previously low (< % worldwide). [ ] [ ] [ ] however, the - influenza season was marked by a worldwide emergence of oseltamivir-resistant seasonal influenza a (h n ) viruses with the h y (h y in n numbering) in the na. [ ] [ ] [ ] [ ] [ ] [ ] the prevalence of oseltamivir resistance was even higher in the subsequent - influenza season with many countries reporting up to % oseltamivir resistance, seasonal and pandemic influenza viruses collected globally between october , and september , were submitted to the who collaborating center for surveillance, epidemiology and control of influenza at the centers for disease control and prevention (cdc) in atlanta, ga, usa, and propagated in madin-darby canine kidney (mdck) cells (atcc, manassas, va, usa). reference viruses representative of oseltamivir-sensitive and -resistant seasonal and pandemic viruses were also propagated in mdck cells. susceptibilities of virus isolates to the nais oseltamivir carboxylate (hoffman-la roche, basel, switzerland) and zanamivir (glaxosmithkline, uxbridge, uk) were assessed in the chemiluminescent ni assay using the na-star tm kit (applied biosystems, foster city, ca, usa) as previously described. additionally, subsets of virus isolates were tested for susceptibility to peramivir (biocryst pharmaceuticals, birmingham, al, usa). fifty percent inhibitory concentration (ic ) values were calculated using jaspr curve fitting software, an in-house program developed at cdc. curve fitting in jaspr was done using the equation: v = vmax · ( ) ([i] ⁄ (ki + [i]))), where vmax is the maximum rate of metabolism, [i] is the inhibitor concentration, v is the response being inhibited, and ki is the ic for the inhibition curve. box-and-whisker plot analyses of log-transformed ic s were performed for each virus type ⁄ subtype and nai using sas . software (sas institute, cary, nc, usa) to identify viruses with extreme ic values (outliers). outliers were characterized based on a statistical cutoff of ic greater than three interquartile ranges from the th percentile. outliers were subjected to genetic analysis by pyrosequencing and ⁄ or conventional sequencing to detect known or novel markers of nai resistance. those harboring previously characterized mutations in the na associated with nai resistance were considered drug-resistant; their descriptive statistics were determined separately from naisusceptible viruses. descriptive statistics to compute the mean, median, and standard deviation (sd), and a one-way analysis of variance were performed on original scale ic data, using sas . software (sas institute) for each nai and virus among seasonal influenza a (h n ) viruses tested for oseltamivir susceptibility (n = ), ( ae %) were outliers for the drug (table ) and harbored the oseltamivir-resistance conferring h y mutation in the na. by contrast, only a small proportion ( ae %) of tested h n pdm viruses (n = ) were resistant to oseltamivir. all influenza a (h n ) viruses (n = ) were sensitive to oseltamivir except for one outlier, a ⁄ ontario ⁄ rv ⁄ with d v mutation in the na, whose ic of ae nm was beyond the statistical cut-value off and > -fold the mean ic for the drug ( ae nm). all influenza b viruses (n = ) were sensitive to oseltamivir with exception of an outlier b ⁄ texas ⁄ ⁄ , with d e (d e in n numbering) mutation in the na, whose ic was beyond the cut-off, but only fourfold greater than the mean ic for the drug. all virus types ⁄ subtypes tested for zanamivir were sensitive to the drug (table ) , except for some outliers among seasonal influenza a (h n ) and a (h n ) outliers. the seasonal influenza a (h n ) outliers included a ⁄ thailand ⁄ ⁄ (h n ) and a ⁄ hawaii ⁄ ⁄ (h n ), both with combined h y and d d ⁄ g mutations in their na. the presence of concurrent mutations at na residues h and d in seasonal influenza a (h n ) virus isolates substantially enhances resistance to oseltamivir and peramivir and ⁄ or zanamivir, however, the changes at d are typically cell-derived and not present in clinical specimens. influenza a (h n ) outliers for zanamivir included a ⁄ ontario ⁄ rv ⁄ with d v mutation in the na, as well as a ⁄ maryland ⁄ ⁄ and a ⁄ vladivostok ⁄ ⁄ with d g and mixed d d ⁄ g mutations, respectively. some mild outliers for zanamivir among a (h n ) viruses with ic beyond the statistical cutoff but < -fold mean ic for the drug were also identified; their genetic analysis revealed presence of wildtype and mutant sequences at residue namely, d d ⁄ g, d d ⁄ n, or d d ⁄ a. mutations at residue d of the na are associated with reduced susceptibility to zanamivir in a (h n ) viruses, but were reported to be cell-culture derived in recent h n viruses. all virus isolates tested for peramivir (n = ) were sensitive to the drug, except for h y variants among seasonal influenza a (h n ) and h n pdm viruses, which exhibited reduced susceptibility to the drug. in addition, one influenza a (h n ) isolate, a ⁄ ontario ⁄ rv ⁄ with d v mutation in the na, showed reduced susceptibility to peramivir. the ic values determined in functional ni assays provide valuable information for detection of resistant viruses, but should not be used to draw direct correlations with drug concentrations needed to inhibit virus replication in the infected human host, as clinical data to support such inferences are inadequate. nevertheless, combining elevated ic values with the presence of established molecular markers of resistance in the na of virus isolates and their matching clinical specimens provides a reliable and reasonably comprehensive approach of identifying nai-resistant isolates for surveillance purposes. in this study, outliers with elevated ic values for oseltamivir among seasonal influenza a (h n ) and h n pdm viruses were confirmed to be oseltamivir-resistant based on the presence of the h y mutation in the na. outliers for oseltamivir and ⁄ or zanamivir among influenza a (h n ) viruses in this study were shown to harbor mutations at d , which were earlier associated with reduced susceptibility to zanamivir, and were cell-culture derived. the effects of d mutations on nai susceptibility appear to be strain-specific; however, there are no conclusive supporting data and further investigations are required. outliers among the influenza a viruses in this study exhibited changes in the na, derived naturally or through cell-culture, which altered their susceptibility to nais. however, mild outliers for oseltamivir and ⁄ or zanamivir among influenza a viruses with slightly elevated ic s, but without apparent changes in the na are sometimes identified. in such instances it is imperative to exclude the potential presence of influenza b among such outliers, using conclusive genetic tests such as real time pcr, since influenza b viruses exhibit higher ic values for oseltamivir and zanamivir than influenza a viruses. viruses exhibiting such mixes are typically excluded from statistical analyses of ic s for respective drugs and virus type ⁄ subtype. establishment of a clinically relevant ic cutoff value which could be used to differentiate statistical outliers from truly resistant viruses is imperative. global surveillance for nai susceptibility of influenza viruses circulating globally should be sustained to reflect the impact of seasonal and pandemic of influenza, given the limited pharmaceutical options available for control of influenza infections. nasopharyngeal swab specimens from patients with acute respiratory infection were collected at influenza sentinel surveillance units (outpatient and hospital-based) all over mongolia. specimens were transported to the virology laboratory, nccd, ulaanbaatar, and rt-rt pcr positive samples were grown in a mdck cell culture according to the protocol developed by cdc. and influenza virus gene segment (m genes) sequencing ( strains-genbank accession numbers: cy , cy , cy , cy , cy , cy , and cy ) and influenza virus gene segment (na gene) sequencing ( strains genbank accession numbers: cy and cy ) by the standard methods with applied biosystems xl genetic analyzer using primers supplied by who collaboration centers. a chemiluminescent na inhibition assay was performed with veritas microplate luminometer using the commercially available kit, na-star (applied biosystems, foster city, ca, usa), according to the manufacturers protocol. the na inhibitor susceptibility of influenza virus isolates was expressed at the concentration of na inhibitor needed to reduce na enzyme activity by % (ic ). oseltamivir carboxylate, was provided by f. hoffman-la roche ltd (basel, switzerland). na inhibition assay data were analyzed using robosage software comparing test data with the data produced by the reference na inhibitor sensitive and resistance strains, which were provided by the who influenza collaboration center, melbourne, australia. all viruses tested were sensitive to oseltamivir with two exceptions: a seasonal influenza virus a ⁄ ulaanbaatar ⁄ ⁄ (h n ) with ae nm ic value and a pandemic influenza virus a ⁄ dundgovi ⁄ ⁄ (h n ) with ae nm ic value ( figure ). there was oseltamivir resistance detected in ae % ( ⁄ ) of seasonal a (h n ) and in ae % ( ⁄ ) of a (h n ) pdm viruses. the oseltamivirresistant viruses were collected from untreated patients. in total, influenza b viruses were analyzed by na inhibition assay and all were sensitive to oseltamivir. the na of both oseltamivir-resistant strains contained h y mutation based on the sequencing analysis. the difference in the na amino-acid sequences between the mongolian oseltamivir-resistant viruses and the respective oseltamivir-sensitive reference viruses is shown in table all a(h n ) viruses analyzed for m channel inhibitor resistance by pyrosequencing contained the s n mutation and, thus, were resistant to this class of anti-influenza drugs. the segment sequencing revealed that seasonal a(h n ) viruses possess the common s n mutation. of note, a single strain a ⁄ zavkhan ⁄ ⁄ (h n ) contained an unusual s d change in the m protein. our study shows that the same prevalence [ ae % ( ⁄ )] of seasonal a(h n ) viruses with h y mutation in ⁄ season in mongolia with the published data for ⁄ season from japan. , however the prevalence of oseltamivir resistance in japan has dramatically increased in ⁄ season to % ( ⁄ ). the observed double mutations: h y and d g in a ⁄ ulaanbaatar ⁄ ⁄ (h n ) strain, which have been also found in japan in ⁄ season. the patient from whom the oseltamivir resistant seasonal influenza h n virus has been isolated was a -year-old boy, living in ulaanbaatar, the capital city, without history of using oseltamivir. the patient from whom the oseltamivir resistant a(h n )pdm virus was isolated was a year-old man, residing in the dundgovi, the southern province, also without history of antiviral treatment. according to the who data, isolation of the pandemic viruses carrying h y change from untreated patients has been uncommon. circulation of amantadine-resistant seasonal a (h n ) viruses has been increasing in mongolia since ⁄ influenza season. all pandemic influenza a(h n ) strains ( ) tested were resistant to m channel inhibitors due to the presence of the s n mutation in the m protein. among seasonal a(h n ) viruses, one contained a s d change whereas the others had s n, the well established marker of resistance to both amantadine and rimantadine. this is the first report of detecting the s d change in the seasonal a(h n ) viruses. according to the cdc data (unpublished), the s d change conferred the drug resistance in the a(h n ) viruses according to the virus yield reduction assay. it is essential to continue the antiviral resistance surveillance of influenza virus strains circulating in mongolia to ensure the efficiency of a proper clinical management of influenza patients. (conferred by the s n mutation). of note, the genotype and genotype dual resistant viruses from asia appear to be genetically similar to those previously reported dual resistant viruses from hong kong, sar. , the genotype virus was the only dual resistant virus with a nearly complete c genome. oseltamivir-resistance for this virus appears to be the result of a reassortment as demonstrated by the presence of the oseltamivir-resistant clade b na gene. although the detection of dual resistant seasonal influenza a (h n ) viruses is still rare, there has been an increased prevalence of dual resistance viruses during the last three seasons: . % ( of tested in - ), . % ( of in - ) , and % ( of in - ) (v p < . ). while the continued circulation or co-circulation of seasonal a (h n ) viruses is uncertain, the emergence of dual resistant influenza viruses in five countries does present a public health concern, especially since dual resistant viruses would limit the options for antiviral treatment to a single licensed antiviral drug: zanamivir. moreover, the markers of resistance seen in seasonal a (h n ) viruses also confer resistance in the more widely circulating pandemic a (h n ) virus. and, since the acquisition of mutations in influenza a viruses typically occur through drug selection, spontaneous mutation, or genetic reassortment with another drug resistant influenza a viruses, the detection of influenza a (h n ) viruses that are resistant to both adamantanes and oseltamivir warrants close monitoring, even if only detected at low frequency. new antiviral agents and strategies for antiviral therapy are likely to be necessary in the future. heightening concern that drug resistance will likewise become prominent in pandemic viral strains and highlighting the need for antiviral drug resistance surveillance. the h y mutation in h n neuraminidase is the most common mutation conferring resistance. however, due to the high mutation rates of viruses, new mutations can be expected that will also render viral neuraminidase less sensitive to antiviral drugs. pcr methods can be used to detect previously identified mutations; however, functional neuraminidase enzyme activity inhibition testing is necessary for detecting drug resistance that results from novel mutations. the two neuraminidase enzyme inhibition assays using either the fluorescent munana or chemiluminescent na-star Ò substrate are robust tools for ni susceptibility testing. the munan-a-based assay is broadly used by many groups, including many regional health organizations for ni susceptibility testing, yet no standardized protocol or dedicated kit has been in place for this assay, making comparison of data generated between different laboratories difficult. borrowing from multiple neuraminidase inhibitor susceptibility network (nisn)-published munana-based neuraminidase assay protocols, we have developed a kit-based fluorescent neuraminidase assay that offers both standardization and off-the-shelf quality-controlled reagents for ni susceptibility testing and other neuraminidase assay applications. the na-fluor tm influenza neuraminidase assay reagents and protocols were optimized in comparison to published nisn protocols according to the criteria of assay performance, ease-of-use, consideration of historically used assay conditions, reagent storage stability, and environmental impact. our optimized assay conditions consists of lm munana, ae mm mes, mm cacl , and ph ae in a ll assay volume, and performing the assay for minutes at °c following a minutes preincubation of drug with the virus. these conditions are consistent with the majority of published influenza ni screening data in publication. the standard na-fluor tm assay workflow for screening viral isolates for sensitivity to nis includes first titering the viral sample by neuraminidase activity to determine optimal virus concentration to be used in subsequent ic determination assays. the na-fluor tm assay is an ideal tool for titering virus based on neuraminidase activity in the viral coat. titering of viral samples prior to running the ic determination assays insured that assays would be performed within the fluorescence detection dynamic range of both the assay and the fluorometric instrument being used. viral titers giving rfus in the range of - were used for subsequent assays. comparison to traditional munana assays a primary goal of developing a standardized munana assay was to provide a standardized protocol and set of reagents that would allow for comparison of ni surveillance data between laboratories and over time. in addition, the assay should provide data comparable to historical data sets based on traditional munana-based protocols. to insure that our newly developed na-fluor tm assay met these criteria we performed side-by-side comparisons of the na-fluor tm assay to munana-based nisn protocols, as well as our na-xtd tm and na-star Ò chemiluminescent neuraminidase assays to compare assay sensitivity and dynamic range and for ni ic determination with multiple viral isolates. for all assay comparisons, assays were performed according to respective published protocols. for direct comparison of results, an equivalent amount of virus (and concomitant neuraminidase activity) was used for each assay. the na-fluor tm assay provides low-end sensitivity (by signal to noise ratio) and dynamic range similar to nisnpublished, munana-based protocols (data not shown). these assays all show a low-end detection of approximately ae u ⁄ well and dynamic range of - orders of magnitude when performed simultaneously side-by-side using serial dilutions of bacterial (clostridium perfringes) neuraminidase. these assays show approximately onefold less dynamic range and approximately fivefold less low-end sensitivity than chemiluminescent assays under these conditions. given the large amount of archived ni inhibition data for viral isolates over the past decade, it is very important for a standardized assay to generate data similar to established protocols so that data can be compared in relative terms. when run side-by-side, na-fluor tm assay provided oseltamivir carboxylate and zanamivir ic values similar to nisn-published, munana-based protocols. ic values vary somewhat for munana assays versus chemiluminescent assays depending on the viral isolate, as previously described. the na-fluor tm assay also exhibited similar sensitivity for detecting ni sensitive virus compared to nisn-published fluorescent assays as shown in figure . the large shift in ic values between oseltamivir-sensitive and resistant virus using the na-fluor tm assay enables detection of mutant virus in mixed viral samples ( figure ). this capability is critical for identifying resistant virus in clinical isolates presenting mixed populations of resistant and sensitive virus during ni susceptibility surveillance. several characteristics of the na-fluor tm assay make it an ideal assay for processing large numbers of viral isolates for ni sensitivity surveillance or for using the assay for high throughput screening for lead discovery of new antiviral reagents. the na-fluor tm assay signal was found to remain stable for up to hours after stop solution addition when stored at room temperature and for several days when stored at °c (data not shown). ic values did not change over these times, indicating that the assay is compatible with processing many samples in a short time frame. the na-fluor tm assay was also found to be highly reproducible giving a z' of ae or above indicating that the assay can be used confidently to identify nis in high throughput screening mode. the assay can tolerate up to % dmso, a common compound delivery reagent used in high throughput screens (data not shown). we have developed a standardized na-fluor tm assay suggested protocol that gives data similar to established mun-ana protocols. however, we have also found that several protocol adaptations can be made that generate comparable data while allowing the user more flexibility in assay mode, use of additional reagents, and to meet user-specified assay time requirements. the na-fluor tm assay can be run in either the standard minutes ⁄ °c endpoint mode described above or as real-time kinetic assay with repeated reads taken over time without the addition of stop solution, which both serves to terminate neuraminidase activity and to enhance the fluorescence of the product. for typical ni-sensitive viral strains, the rate of munana substrate turnover at °c is linear for at least hours (data not shown). as would be expected, rates of substrate turnover decrease in the presence of nis reflected in a decreased slope exhibited by real-time kinetic reads. real-time acquired rfus are typically - fold lower than rfus acquired after addition of stop solution at the same time point. ic values obtained using slope analysis for real-time assays are similar to values obtained by endpoint analysis. whether run in real-time or end-point mode, the linear rate of substrate turnover allows the user to run the assay for shorter or longer assay times than the standard protocol without compromise to assay performance. the na-fluor tm assay is also compatible with standard methods used in many laboratories to inactivate virus. we have shown that ni ic values for multiple viral strains remain unchanged when the assay is performed in the presence of ae % np- or % triton x- (data not shown). similar results are also obtained by adjusting the na-fluor tm stop solution to % ethanol prior to addition for assay termination. the assay is unaffected by phenol red concentrations present in cell culture media. we have developed a standardized munana-based fluorescent neuraminidase assay, the na-fluor tm influenza neuraminidase assay kit, which has been optimized for ni susceptibility screening. the assay provides data that can be compared to data generated using traditional munanabased protocols. the assay is economical, highly reproducible, easy to use, and environmentally friendly. the assay is flexible and amendable to user-specific adaptations including assay mode, assay timing, and reagent compatibility. trademarks ⁄ licensing ª life technologies corporation. all rights reserved. relenza is a registered trademark of glaxo- to test the prophylactic potency of h -vhhb, mice were treated intranasally with pbs, lg of h -vhhb, or negative control rsv-vhhb at , , or hours before infection with one ld of nibrg- ma virus. body weight loss was monitored daily, and on day mice were sacrificed to determine the viral load in the lungs. all mice that received h -vhhb retained their original body weight, whereas those receiving pbs or rsv-vhhb gradually lost weight (data not shown). intranasal administration of h -vhhb at or hours before challenge resulted in undetectable lung virus titers. when animals were treated with h -vhhb hours before challenge, virus titers were fold lower compared to pbs and rsv-vhhb treated mice, and three out of seven animals still had undetectable virus titers ( figure ). we next determined if h -vhhb nanobody Ò could be also be used therapeutically. we administered lg of this nanobody Ò intranasally to mice up to hours after chal-lenge with ld of nibrg- ma virus. four days after challenge, animals that received h -vhhb , , or hours after challenge had significantly higher body weight (data not shown) and lower lung virus loads than control mice. although mice treated with h -vhhb nanobody Ò hours after challenge were not clinically protected compared to control mice, they had significantly lower lung virus titers (figure ). to identify the ha amino acid residues that are potentially involved in h -vhh binding, escape viruses were selected by growth and plaque purification of nibrg- ma virus in the presence of h -vhhm or h -vhhb nanobodies Ò . the ha sequences of six independently isolated h -vhhm escape viruses revealed substitution of a lysine by a glutamic acid residue at position in ha (h numbering). in addition, two h -vhhm escape mutants carried an n d and four carried an n s substitution. the three-dimensional structure of nibrg- ha shows that n d ⁄ s and k e are close to each other as part of the corresponding antigenic site b in h ha. , interestingly, the n d ⁄ s mutations remove an n-glycosylation site, which is surmised to have evolved in h n ha as a strategy to mask an antigenic site. escape viruses selected in the presence of h -vhhb carried k n (n = ) or k e (n = ) substitutions. these results indicate that residues in antigenic site b, at the top of ha and very close to the receptor binding domain (rbd), are essential for neutralization of the virus by h -vhhm ⁄ b nanobodies Ò (figure ). the virus titer was measured in lung homogenates prepared on day after challenge. the x axis refers to the time points in hours relative to the challenge (time = hours) when ha-specific nanobodies (h -vhhb), control nanobodies (rsv-vhhb) or pbs was administered to the mice. # below detection limit, n not determined [n = - mice per condition: p values < ae (*)]. here we demonstrated that prophylactic and therapeutic treatment with llama-derived immunoglobulin single variable domain fragments is effective to control infection with h n influenza virus in a mouse model. we demonstrate that pulmonary delivery is a highly effective route of administration to treat or prevent influenza virus infection. in addition, we demonstrate that a homobivalent h -vhhb has powerful h n -neutralizing activity in vivo. it is important to note that we used a mouse-adapted derivative of the non-highly pathogenic nibrg- virus in our challenge model. nevertheless, this virus induces severe morbidity and lethality in mice. compared to conventional neutralizing monoclonal antibodies, vhhs offer the advantage that they are easy to produce in escherichia coli, typically with high yield. in addition, their small size ( kda for a monovalent vhh) and high folding capacity allow the generation of oligovalent vhh derivatives. in vitro escape selection revealed that a k e substitution in ha abolished the neutralizing effect of h -vhhm ⁄ b. a lys or arg residue at this position is conserved in all human h n virus isolates. of note, all selected escape mutants contained a glutamic acid or serine residue at position , which suggests that the conserved positively charged amino acid is important for neutralization by h -vhh nanobodies Ò . interestingly, escape mutants selected with h -vhhm also carried an n d ⁄ s co-mutation that removes an n-glycosylation site in this antigenic site of ha. the predicted n-glycosylation site at n in a ⁄ hong kong ⁄ ⁄ ha was shown to be glycosylated and may have evolved to mask an antigenic site near the rbd. , the selected amino acid changes are located near the receptor binding site of ha. therefore, it is possible that enhanced receptor binding properties of these escape viruses contribute to or are responsible for the loss of neutralizing activity of h -vhh nanobodies Ò . , we conclude that influenza virus neutralizing nanobodies Ò have considerable potential for the treatment of h n virus infections. although we focused on vhhs that presumably recognizes an epitope near the rbd, it is possible to select vhh molecules that bind to other epitopes in ha, including more conserved domains. more, a novel na (i m) substitution was discovered in a series of specimens from a patient. for the amantadine resistance, samples were tested, and all of them were confirmed to be resistant. we collected respiratory specimens from patients who had been clinically refractory to antiviral treatment since october upon ethical approval from the relevant institutions. to investigate the resistant pattern, sequence analysis to the na and matrix (m ) genes were conducted by reverse transcription (rt)-pcr and sequencing reaction. the obtained sequences were analyzed by the influenza sequences and epitopes database, which was developed in korea. eleven patients were found to be having oseltamivir-resistant pandemic (h n ) viruses with the h y substitution in the viral na genes (tables and ). some cases were associated with oseltamivir treatment on the basis of h y change from the oseltamivir-sensitive genotypes to oseltamivir-resistant genotypes in consecutive samples from the same patient. furthermore, a novel na (i m) substitution that may be associated with oseltamivir resistance was detected in specimens from one patient (patient g) who had myelodysplasia and received oseltamivir and peramivir (tables and ). in addition, we obtained viruses from clinical specimens (patients a and c) and evaluated antiviral susceptibility by measuring the dose of oseltamivir and zanamivir required for % inhibition (ic ) of na activity. these viruses (from patients a and c) were resistant only to oseltamivir (ic ae and ae nmol ⁄ l, respectively). susceptibility to zanamivir was not altered whether na contained y or h (ic ae and ae nmol ⁄ l, respectively). one isolate of pandemic (h n ) virus with an oseltamivir-sensitive genotype (h in its na) was susceptible to oseltamivir (ic ae nmol ⁄ l) and zanamivir (ic ae nmol ⁄ l). patients with oseltamivir-resistant pandemic (h n ) were treated during hospitalization with oseltamivir alone or with a combination of other antiviral drugs ( we found patients of oseltamivir resistance with h y mutation in the na gene of pandemic (h n ) virus through the surveillance of patient refractory to antiviral treatment. in addition, novel amino acid change (i to m) at position in the na gene, which might influence oseltamivir susceptibility, was detected in sequential specimens of a patient. these data showed that generation of oseltamivir resistance could be associated with oseltamivir treatment. therefore, it needs to strengthen the antiviral monitoring by supplementation of the clinical data including antiviral treatment. during the pandemic, oral oseltamivir was the primary antiviral medication used for treatment of hospitalized patients with ph n infection. many physicians worried that clinical deterioration or failure to respond to treatment with oseltamivir was due to either oseltamivir resistance or oseltamivir failure. in the united states, two investigational intravenous (iv) nais were available during - : peramivir through emergency use authorization and zanamivir by investigational new drug application. peramivir would be an option for patients with oseltamivir failure, but would not be appropriate for patients infected with h y oseltamivir resistant mutants. iv zanamivir was available in limited supply, but would be appropriate for severely ill patients infected with an oseltamivir-resistant ph n virus. during the pandemic, clinicians had few options for antiviral resistance testing in the united states. to respond to this need, the us centers for disease control and prevention (cdc) offered antiviral resistance testing for patients suspected to have clinical failure due to oseltamivir resistance. we describe the methods that cdc used to prioritize patients for testing during the pandemic and to detect markers for oseltamivir resistance, as well as the results from this testing. to facilitate decisions on which patients to test, we developed testing algorithms that were shared with state labora-tories, epidemiologists, and the emergency operation center at cdc. we prioritized patients who might benefit the most from antiviral testing given the inherent delay in providing antiviral results, e.g. patients who might have prolonged ph n shedding. patients that were critically ill [intensive care unit (icu) admission] or patients with severe immunocompromising conditions with clinical evidence for oseltamivir treatment failure (persistent detection of virus and clinical unresponsiveness to the drug) were prioritized. in addition, we tested specimens from patients that failed oseltamivir chemoprophylaxis. standard forms with information regarding specimen and minimal clinical information were collected on all patients. all protocols were validated and approved by clinical laboratory improvement amendments, e.g. quality standards to ensure accuracy, reliability, and timeliness of patient test results. information collected on patients was deemed public health response, not research, at cdc. clinical specimens, confirmed as pandemic influenza a (h n ), were tested for the h y mutation in the na using pyrosequencing. results were returned to sender within - hours of specimen receipt. from october until july , a total of specimens from patients were submitted for testing. viruses from ( %) of patients had h y mutation in the na in at least one submitted specimen. clinical information was available for patients (table ) . most patients had received oseltamivir for treatment prior to obtaining the specimen sent for antiviral testing. four patients received oseltamivir for chemoprophylaxis, all were immunosuppressed, and all had the h y mutant; duration of chemoprophylaxis until ph n infection was detected varied ( - days). among the patients with an h y mutant who were treated with oseltamivir, the median time on oseltamivir prior to collection of specimen with h y mutation was days (range - days). three patients were part of a hospital cluster of oseltamivir-resistant virus infections and were infected with h y mutants prior to oseltamivir treatment. patients with immunocompromising conditions accounted for almost half of all patient specimens tested, but they accounted for the majority of oseltamivir-resistant ph n virus infections (table ) ; among individuals with severe immunocompromising conditions and clinical failure while on oseltamivir therapy, ( %) had the h y mutant detected. among the immunosuppressed patients with an oseltamivir-resistant virus, ( %) had hematologic malignancies reported. in contrast, among the subset of icu patients without immunocompromising conditions and clinical failure while on oseltamivir therapy, we found little resistance: ( ae %) of icu patients had oseltamivir resistance detected. during the pandemic, we were able to provide timely and useful information to clinicians regarding suspected cases of oseltamivir resistance. our testing algorithm limited the number of specimens to specimens from the highest risk patients that would benefit the most from antiviral treatment. such an approach allowed us to offer this service without compromising our public health duties. in addition, the information we collected on patients from this service complimented our data on the national surveillance for antiviral resistance. we also performed national antiviral resistance surveillance from april to july . overall, resistant ph n viruses were identified from april to july in the united states among tested samples, including specimens described above, surveillance specimens, and resistant viruses reported in the literature. further studies to understand risk factors for oseltamivir-resistant ph n infection in patients with severe immunocompromising conditions are needed. while efforts to provide antiviral testing technology and materials to state laboratories are ongoing, clinicians still have limited options for such testing. rapid and inexpensive assays that could be performed by clinical laboratories, especially those caring for immunosuppressed patients, would be useful to inform patient care. the applied biosystems Ò na-xtd tm influenza neuraminidase assay kit provides the next-generation na-xtd tm , -dioxetane chemiluminescent neuraminidase (na) substrate, together with all necessary assay reagents and microplates, to quantitate sensitivity of influenza virus isolates to neuraminidase inhibitors. like the na-star Ò influenza neuraminidase inhibitor resistance detection kit, the na-xtd tm influenza neuraminidase assay provides highly sensitive detection of influenza neuraminidase activity. in addition, the na-xtd tm assay provides extended-glow light emission that eliminates the need for reagent injection and enables signal measurement either immediately or up to several hours after assay completion. the na-xtd tm assay is also used to quantitate influenza na activity directly in cellbased virus cultures to monitor viral growth or inhibition. global monitoring of influenza strains for resistance to neuraminidase inhibitors (nis) is essential for understanding their efficacy for seasonal, pandemic, or avian influenza, and studying the epidemiology of viral strains and resistance mutations. functional neuraminidase inhibition assays enable detection of any resistance mutation, making them extremely important for global monitoring of virus sensitivity to nis. the first-generation chemiluminescent na-star Ò influenza neuraminidase inhibitor resistance detection kit has been widely used for virus ni sensitivity assays, - including identification of a ⁄ h n pandemic virus resistant to oseltamivir. , in addition, this assay has been used for identification of new ni compounds, ni characterization, studies of virus transmission, drug delivery, na quantitation of virus-like particles, and cell-based virus quantitation. neuraminidase assays performed with chemiluminescent , -dioxetane substrates, including na-star Ò and na-xtd tm substrates, typically provide -to- -fold higher sensitivity by signal-to-noise ratio than assays performed with the fluorescent munana substrate. in addition, chemiluminescent assays provide linear results over - order of magnitude of neuraminidase concentration compared to - orders of magnitude with the fluorescent assay. the high assay sensitivity achieved with chemiluminescent assays enables use of lower concentrations of viral stocks, and the wide assay range minimizes the need to pre-titer virus stocks prior to ic determination. chemiluminescent reactions result in conversion of chemical energy to light energy, as light emission. the na-xtd tm substrate is a , -dioxetane structure bearing a sialic acid cleavable group. to perform the na-xtd assay, virus dilutions (from cell culture supernatant) are pre-incubated in the presence of neuraminidase inhibitor. then na-xtd substrate is added and incubated for minutes for substrate cleavage to proceed. finally, light emission is triggered upon addition of na-xtd accelerator, which provides a ph shift and a proprietary polymeric enhancer, both required for efficient light emission. chemiluminescent assays are performed in solid white microplates, and light emission is measured in a luminometer. the na-xtd tm substrate has a single structural difference from the na-star Ò substrate that provides a much longer-lasting chemiluminescent signal, with a signal half-life of approximately hours (not shown), compared to $ minutes with the na-star assay, eliminating the need for luminometer instruments equipped with reagent injectors and enabling more convenient batch-mode processing of assay plates. the na-xtd tm assay kit also provides a new accelerator solution, containing a next-generation polymer enhancer, and a triton Ò x- -containing sample prep buffer providing enhanced na activity. read-time flexibility is demonstrated by determination of oseltamivir ic values using data collected over hours after addition of na-xtd tm accelerator. although signal intensity slowly decreases over time, the ic curves and values are identical at each time point, shown using influenza b ⁄ lee ⁄ ( figure ) . triton x- detergent at % has been shown to inactivate flu virus while increasing neuraminidase activity. the addition of na sample prep buffer (containing % triton x- ) to virus stocks (at ⁄ volume, achieving a final concentration of %) provides increase in na activity up to fourfold, but is not consistently observed, and seems to be most effective with more concentrated virus stocks. ic values are unaffected by the addition of triton x- to the virus stock prior to virus dilution (not shown), so the assay is compatible with known virus inactivation reagents. assay sensitivity and ic values determined with the na-xtd assay have been compared to those obtained with both the chemiluminescent na-star assay and the fluorescent na-fluor assay (not shown). the chemiluminescent assays provide -to -fold higher sensitivity by signal-to-noise ratio, depending on the virus strain, wider assay dynamic range, and better low-end detection limit than the fluorescent assay. the wide assay range with the chemiluminescent assays enables determination of ic values over a range of virus concentrations, eliminating the need to titer virus prior to performing ic determination assays. ic values obtained with the na-xtd assay are nearly identical to those obtained with the na-star assay, with both oseltamivir and zanamivir neuraminidase inhibitors, and tend to be slightly lower than ic values obtained with the fluorescent assay. viral na quantitation provides a convenient read-out to measure viral growth or inhibition, including inhibition in the presence of inhibitory compounds or antibodies, described as accelerated viral inhibition with na as readout assay (avina). bation in the presence of varying concentrations of oseltamivir carboxylate. samples of culture media were assayed hours later. quantitation of na activity with the na-xtd tm assay demonstrates inhibition of viral growth by oseltamivir carboxylate in cell culture ( figure ). different volumes of culture media were assayed with the na-xtd assay, either in the culture plate or in a separate assay plate (not shown). performing the assay using the entire well contents ( ll) reduces assay sensitivity due to the high concentration of phenol red. assaying a smaller volume of culture medium (either in culture plate or a separate assay plate) provides higher sensitivity, and enables temporal monitoring or use of remaining culture medium for other assays. the applied biosystems Ò na-xtd tm influenza neuraminidase assay kit is a next-generation chemiluminescent neuraminidase assay providing high assay sensitivity and ''glow'' light emission kinetics for improved ease-ofuse. the applied biosystems Ò na-fluor tm influenza neuraminidase assay kit, based on the fluorescent mun-ana substrate, has also been developed to complement the na-xtd tm and na-star Ò chemiluminescence assays, for users lacking luminometer instrumentation or choosing to use fluorescence assay detection. together these kits offer: • standardized reagents and protocols • choice of detection technology • simple instrumentation requirements • high sensitivity for use with low virus concentrations • compatibility with batch-mode processing and largescale assay throughput • broad specificity of influenza detection • flexibility in assay format • additional na assay applications -cell-based viral assays, screening for new nis, detection of na from other organisms functional neuraminidase inhibition assays enable detection of any resistance mutation and are extremely important in conjunction with sequence-based screening assays for global monitoring of virus isolates for ni resistance mutations, including known and new mutations. together, these assays provide highly sensitive, convenient and versatile assay systems with standardized assay reagents, and simple assay protocols for influenza researchers. over hospitalizations and deaths in the us annually are attributable to seasonal influenza, primarily in chronically ill persons and the elderly. - following the emergence of pandemic h n influenza, severe illnesses have also been observed in children and young healthy adults. the occurrences of staphylococcal and pneumococcal pneumonia complicating influenza pandemics are well described. [ ] [ ] [ ] although temporal associations of bacterial pneumonia and influenza circulation have been reported, there is little precise data on rates of bacterial complications of seasonal or pandemic influenza. the study of bacterial lung infection has been hampered by insensitive tests for invasive disease and the difficulty of interpreting routinely obtained sputum culture results. , procalcitonin (proct), the prohormone of calcitonin, can discriminate viral and bacterial infections. this -aminoacid precursor protein normally produced by neuroendocrine cells of the lungs and thyroid gland was first shown to be elevated in bacterial infections in patients with pulmonary injury and pneumonitis. stimuli of proct include tnf-a, endotoxin, and other bacterial products. several studies indicate that bacterial infections commonly induce hyperprocalcitonemia, but that viral infections, including h n , are associated with only minimal increases. , , of note, proct induction is attenuated by viral-induced interferon-c. a meta-analysis of studies comparing proct and crp as markers for bacterial infection found that proct was more sensitive and specific than crp for differentiating bacterial from other causes of inflammation. , therefore, we measured proct levels in patients with seasonal and pandemic influenza and compared results with conventional methods for bacterial diagnosis. adults ‡ years of age admitted to rochester general hospital (rgh) from november st to june th for two winter seasons ( - ) with an admitting diagnosis compatible with acute respiratory tract infection were recruited for the study. patients were screened within hours of admission, and those with prior antibiotic use, immunosupression, or pregnancy were excluded. subjects or their legal guardian provided written informed consent. the study was approved by the university of rochester and rgh research subjects review board. at enrollment demographic, clinical and laboratory information was collected. influenza testing included nosethroat swabs (nts) for rapid antigen, viral culture, and reverse transcription-polymerase chain reaction (rt-pcr) and serology. testing for bacterial pathogens included blood cultures, sputum for culture and gram stain, nts for mycoplasma pneumoniae and chlamydophila pneumoniae pcr, s. pneumoniae antigen testing, and pneumococcal serology. if patients were unable to expectorate, sputum was induced with normal saline and bronchodilators. specimens were considered adequate by the standard criteria of > neutrophils (pmns) and < epithelial cells per high power field. serum was collected at admission and hospital day for proct measurements. influenza infection was defined a positive result for any of the following tests: . cloned proteins were coated on eia plates at ug ⁄ ml in bicarbonate buffer. after overnight incubation, plates were washed and two-fold dilutions of serum were incubated overnight at room temperature. plates were washed and incubated with alkaline phosphatase conjugate for hours, followed by substrate. a greater than or equal to fourfold rise in titer was considered evidence of infection with s. pneumoniae. urinary antigen for s. pneumoniae samples were assayed for antigen using the binax now kit. (binax inc, scarborough, me, usa). the proct was measured using time resolved amplified cryptate emission technology (kryptor pct; brahms, henningsdorf, germany). functional sensitivity is ae ng ⁄ ml (normal levels are ae ± ae ng ⁄ ml). mycoplasma and chlamydia pcr real-time pcr targeting the p adhesion gene for m. pneumoniae and the ompa gene for c. pneumoniae was used to detect atypical bacteria. results fifty-one of ( ae %) illnesses evaluated tested positive for influenza virus. of these, were due to ''seasonal influenza'' ( influenza a ⁄ h n and influenza b), and were identified as ''pandemic influenza'' ( h n ). demographics of both groups were similar: mean ages ± and ± years, respectively, and equivalent sex and racial characteristics. other than a higher incidence of underlying lung disease in the seasonal group ( % versus %, p = ae ), pre-existing medical conditions including obesity were similar. symptoms, physical findings, and discharge diagnoses did not differ, and chest radiographs (cxr) showed infiltrates in % and % of seasonal and pandemic subjects, respectively. two pandemic and one seasonal influenza patient developed respiratory failure, and none died. overall, bacterial infections were diagnosed in ( %) subjects ( -seasonal and -pandemic), and none were bacteremic. bacterial infections included: -s. pneumoniae, -m. pneumoniae, -s. aureus, and -h. influenzae. all seasonal patients were diagnosed with asthma or bronchitis, whereas three pandemic patients had pneumonia. mean serum proct (ng ⁄ ml) levels in seasonal versus pandemic patients on admission and day were: ae ± ae versus ae ± ae and ae ± ae versus ae ± ae , respectively, and were not significantly different (table ) . several patients in the pandemic group had high proct levels, and there was a trend toward more pandemic patients having admission proct values ‡ ae ng ⁄ ml than seasonal subjects [ ( %) versus ( %), p = ae ] ( figure a , b). of the four patients with proc-t > ae ng ⁄ ml, two had dense infiltrates on cxr, one had a peripheral wbc of ⁄ ml with a threefold increase in s. pneumoniae antibody, and one developed respiratory failure associated with copd exacerbation. reliable sputum samples (within hours of antibiotics) were collected in only ( %) subjects. of these, proct was ‡ ae ng ⁄ ml in two with influenza alone and three associated with bacterial infection, and < ae ng ⁄ ml in with influenza alone and five associated with bacterial infection. in the with reliable sputa and accepting the conventional bacterial diagnosis, sensitivity of a proc-t ‡ ae ng ⁄ ml for bacterial infection was %, specificity %, positive predictive value %, and negative predictive value %. notably, one patient considered to have influenza alone (proct - ae ng ⁄ ml) had group a streptococcus and s. aureus in a contaminated sputum and bilateral infiltrates on cxr. three of five patients with bacterial infections and proct < ae ng ⁄ ml had a clinical diagnosis of bronchitis. mean proct values were significantly higher in patients with infiltrates versus those with atelectasis or no acute disease on cxr ( ae ± ae ng ⁄ ml versus ae ± ae ng ⁄ ml, p = ae ). combining patients with proct values ‡ ae ng ⁄ ml with those having positive bacterial tests, rates of bacterial infection associated with seasonal and pandemic influenza were % and %, respectively. notably, antibiotics were administered to % of subjects despite % having no acute disease on cxr. in our study, bacterial infections were diagnosed in approximately % of adults hospitalized with influenza with no significant difference in rates noted between seasonal and pandemic influenza infected subjects. previous reports of bacterial infection rates of - % with seasonal influenza are difficult to compare with recent studies of pandemic influenza, because the latter tended to focus on more severely ill patients. [ ] [ ] [ ] bacterial pneumonia has been suspected or diagnosed in - % of patients in intensive care associated with h n infection and up to % of patients who died. , despite aggressive pursuit of specimens for bacterial testing, diagnoses could be confirmed in only ( ae %) of patients using conventional methodology. given the difficulty in establishing a diagnosis of bacterial infection, elevated proct values may be helpful to identify patients at high risk for invasive disease. in a study of patients with severe h n or bacterial infection necessitating intensive care, a threshold proct level of ae ng ⁄ ml, demonstrated % sensitivity and % specificity for bacterial infection. among patients with h n associated pneumonia, many of whom had respiratory failure, a threshold proct value of ae ng ⁄ ml provided a sensitivity of % and specificity of % for bacterial infection. access to samples from lower airways in ventilated patients in these studies may have improved recovery of bacteria and account for the different results we observed. it should be noted that none of our patients were bacteremic, which is a very strong stimulus for proct release. proct levels have been used successfully to guide therapy in community acquired pneumonia, and our data showing high proct levels in patients with infiltrates on cxr suggests proct may be most useful for excluding invasive disease. , elevated proct levels were not observed in patients with purulent sputum and clear cxr. it is notable that a proct level of < ae ng ⁄ ml did not exclude patients with bacterial bronchitis since proct has been used to guide antibiotic therapy in copd exacerbations. while it could be argued that healthy patients with bacterial bronchitis do not require antibiotic treatment, physician behavior in our study indicates antibiotics are frequently prescribed. combining patients with proct values ‡ ae ng ⁄ ml and those with a positive bacterial test, approximately % in patients in our study had bacterial complications associated with influenza infection. efforts should be made to curtail antibiotic use in hemodynamically stable patients with clear cxrs. given physician discomfort regarding discontinuing antibiotics, proct measurements in combination with routine bacterial cultures should be useful tools to guide therapy. influenza, mrsa, cytokines: diagnosis, treatment, prevention -a possible strategy for outpatient care we started the antiviral treatment of influenza in humans using neuraminidase inhibitors on january , in a successful attempt to cure a -year-old patient. since then, we have used the inhalant antiviral drug zanamivir, and later (october , ) changed to the use of oseltamivir with systemic bioavailability for treating patients with influenza. after years of experience with antiviral treatment of outpatients, we highlight the importance of early diagnosis and early treatment. the necessity of an earliest possible diagnosis was confirmed in the pandemic of . large hospitals reported that patients with an h n ⁄ infection had to be treated with extracorporeal membrane oxygenation. we are convinced this is due to delayed recognition of infection in most cases. valuable time is lost when the patient with a sudden onset has to be brought to a hospital for emergency treatment. the point at which the patient goes to the doctor is decisive, and this problem of timing and the delivery of early treatment is not specific to germany. in our medical office, we assessed patients with suspected influenza (to date seasonal infections, and in , h n ⁄ ) through clinical diagnosis, and then proven by point of care rapid test (quickvue; quidel, san diego, ca, usa) followed by pcr. all of the patients undergo concomitant lab tests: leukopenia, serum iron level, and the humoral inflammation status [sum of the c-reactive protein (crp) and fibrinogen levels]. because of the constant threat of a bacterial superinfection, a bacterial swab and antibiogram is carried out on every patient. in all cases positive for influenza, oseltamivir was given immediately. nowadays it is important that a double infection with influenza and mrsa must be recognized immediately and treatment started at once with antivirals and, when appropriate, with a suitable antibiotic. we pay particular attention to an extremely low iron level (signum mali ominis). in addition we monitor oxygen saturation and the course of the humoral inflammation status every - hours for every of our outpatients. among our patients with seasonal influenza, we saw within hours, within hours, and within hours after disease onset. for pandemic influenza, it was patients within hours, within hours, and two within hours. for all patients, we measured crp < ae mg and fibrinogen < mg ⁄ dl ( hours), crp < mg and fibrinogen < mg ⁄ dl ( hours), and crp > mg and fibrinogen < mg ⁄ dl ( hours, only seasonal cases). antibiotics were necessary in cases, heparin and oxygen administration in cases. one hundred forty-eight patients had a superinfection following influenza. the most common strains were haemophilus parainfluenzae and staphylococcus aureus. the subsequent use of a suitable antibiotic was only necessary in % of the patients. in all cases diagnosed, treatment (including heparin and oxygen administration) and monitoring were conducted in our medical office. none of our patients (seasonal and pandemic) had to be admitted to hospital. the early decision of whether or not antiviral and antibacterial treatment is taking effect is the only way the threat of a cytokine storm can be averted. not only does the primary care physician have to be aware of the pathophysiology involved, but also the necessary diagnostic and therapeutic options have to be made available to him. the result will lead to a saving of both lives and healthcare costs. this applies both in epidemic as well as in pandemic times. today we know that influenza leaves behind a defenceless immune system, and that the proteases of s. aureus contribute to influenza associated pneumonia. mark von itzstein, who discovered neuraminidase inhibitors, emphasized the synergistic cooperation of viruses and bacteria (personal communication, ). mrsa and influenza viruses are posing problems worldwide. the case of a -year-old boy with h n ⁄ infection demonstrates how fatal developments can be prevented. due to his constantly recurring colds, we had already detected the mrsa colonization years earlier and had always worked on boosting his general health and resistance. both the patient and his family were included in dealing with the problem. the patient was, and is, always vaccinated early with a virosomal vaccine (baxter). during the oktoberfest in munich in september , when h n infections were increasingly occurring, we learned that our patient had come down with an extremely acute feverish illness. with the help of the rapid test, we diagnosed an h n ⁄ virus infection and started treatment with oseltamivir immediately. the humoral inflammation status, which had increased very rapidly to more than ae mg ⁄ dl within hours, was treated with the effective cotrimoxazol from the antibiogram. at the same time, the patient was heparinized. the following day the patient had no fever and was symptom-free. it was only through our early knowledge of what could develop pathophysiologically that we were in a position to make the right decision at the right time. every doctor treating outpatients can follow this procedure if he is familiar with the pathophysiology of the disease and has the available tests on hand: virus rapid test, additional laboratory parameters (leukopenia, iron), and the humoral inflammation status. the decisive factor, however, is the constant clinical alertness towards the course of every acute feverish cold with acute onset. the patient has to remain in the care of the attending physician, and the chosen treatment has to be administered and monitored. this means constant spo measurements and checking the humoral inflammation status every hours. if a clinical worsening occurs during monitoring, the treatment regime has to be changed immediately, which means the administration of an appropriate antibiotic. this outpatient care on the part of the doctor has to be available days a week so that no time will be lost. reports from the netherlands and denmark show that, with the help of this preventive strategy under the motto 'search and destroy,' the dangerous, fatal course of infections reported in germany with at least four deaths a day, can be avoided. however, the doctor has to be adequately remunerated for the elaborate amount of time this intensive outpatient care requires. with our strategy, we have moved from divergence to convergence in the care of our patients. we reported on our years of clinical experience with this approach at the antivirals congress in peking. our main message was early diagnosis and early treatment. we were able to demonstrate this in outpatients with seasonal influenza and h n ⁄ outpatients. our creed is: as much outpatient care as possible and as little hospitalization as possible. virological and autopsy findings in suspected and confirmed fatal cases of h n pandemic influenza in the czech republic -preliminary results influenza viruses cause substantial morbidity and mortality. pandemic influenza may have a serious impact on certain (mainly younger) age groups in comparison with seasonal flu. influenza is one of few viral infections capable of causing a pneumonia that is difficult to cure and ⁄ or leads to sudden death. the aim of this study was to analyze and compare virological and autopsy findings in patients who died with suspected or confirmed h n pandemic influenza virus infection. there were virologically confirmed cases of pandemic influenza and deaths in the czech republic during pandemic wave. more than influenza strains belonging to the new pandemic variant were isolated in the national influenza reference laboratory. postmortem biological samples were collected from any patient who died with suspected influenza infection to test for respiratory viruses. the samples were screened for h n pandemic influenza virus by real-time pcr (rt pcr), and when rt pcr positive, by virus isolation assay. no immunohistochemical staining for influenza antigen was done on the rna pcr positive cases. other important respiratory viruses such as respiratory syncytial virus, parainfluenza viruses, and adenoviruses were detected by virus isolation assay in a suitable cell culture. epidemiological analysis of postmortem histopathologic findings in the airway tissue was carried out in of fatal cases. virological findings were subsequently correlated with histological changes and available demographic and clinical data. statistical analysis was performed by t-test using spss software. sixty-one deaths ( males, females) were analyzed. the rna of the h n pandemic influenza virus was detected by pcr in cases, while cases remained negative. five respiratory syncytial viruses and two adenoviruses were detected in the influenza negative group. the mean age of confirmed h n pandemic influenza victims was ae years, age range - years and median ae years. the mean age of influenza negative victims was ae years, age range - years and median ae years. the % ci for the difference in the age between the two groups is ) ae ; ae . the test is statistically significant at the % level. the obtained significance (p = ae ) can be explained by the relatively small size of the study group. the most common postmortem histopathologic finding in the lung tissue of the h n pandemic influenza virus-positive victims was diffuse alveolar damage (often bilateral) and ⁄ or hyaline membrane formation, possibly with signs of respiratory distress syndrome (in , i.e., ae %, of autopsied patients). in the h n pandemic influenza virus negatives, the most common finding was pneumonia or bronchopneumonia with the detection of various bacterial species (in , i.e., ae % of autopsied patients). the cause might be either primary bacterial infection or superinfection following primary infection with influenza virus that remained undetected. the h n pandemic influenza victims were younger than the patients who died with suspected but undetected h n pandemic influenza. the majority of deaths were primarily linked to rapidly developing respiratory failure. this result supports the previous reports of severe respiratory outcomes in younger age groups that are typically linked to the spread of a pandemic strain of influenza. due to limited amount of pandemic vaccine, especially at the beginning of pandemic, it is advisable to assess experiences with antiviral treatment, mainly dosing, and way of antiviral administration. primers specific for each of the eight genes of pandemic h n ⁄ were adopted from assays as described previously to discriminate against seasonal human h n and h n viral segments (table ) . the primers were allowed to cross-react specifically with the sister clade viral segments of pandemic h n ⁄ . the method we employed in this study was a -step singleplex sybr green-based real-time rt-pcr. this approach helped lower the running cost of the assays and facilitated downstream molecular analyses (e.g., sequencing) by using screened cdna samples. viral rna was extracted from viral cultures or clinical samples as described , and was converted to cdna in a universal rt-pcr. each ll rt reaction containing ae ll of purified rna, ll of · firststrand buffer (invitrogen), u of superscript ii reverse transcriptase (invitrogen), ae lg of uni ( ¢-ag-caaaagcagg- ¢), ae mm of deoxynucleoside triphosphates and mm of dithiothreitol was incubated at °c for minutes, followed by °c for minutes for heat inactivation. for each segment-specific real-time pcr, the ll reaction contained ll of a -fold diluted cdna samples, ll of fast sybr green master mix (applied biosystems), and ae lm of the corresponding primer pair. the thermocycling conditions of all eight segment-specific pcrs were optimized as °c for seconds, followed by cycles of °c for seconds and °c for seconds, and all eight assays were performed simultaneously in a sequence detection system (applied biosystems). at the end of the amplification step, pcr products went through a melting curve analysis to determine the specificity of the assay ( - °c; temperature increment: ae °c ⁄ seconds). cdna of a ⁄ california ⁄ ⁄ virus was used as a positive control. robust and specific amplification was achieved in all eight segment-specific real-time rt-pcr reactions. pcr product for each segment of pandemic h n ⁄ yielded unique melting curve pattern with distinctive melting temperature (tm), which was not observed in negative and water controls ( figure ). reactions with tm value within sds of the mean tm were determined as positive. we evaluated the assays with a number of serologically confirmed human clinical samples. all pandemic h n ⁄ samples (n = ) were positive in all eight assays, while all seasonal samples (h n = ; h n = ) were negative in all assays, as expected ( figure and data not shown). these results showed that no reassortant of pandemic h n and seasonal viruses was present in the tested human isolates. we applied these assays to our on-going influenza virus surveillance program in swine. nasal and tracheal swab samples were collected at an abattoir in hong kong and cultured in madin darby canine kidney cells or embryonated eggs as described. positive viral cultures in hemagglutination assays were tested with the established segmentspecific real-time rt-pcr assays. among swine viral isolates collected from to september , of them were recognized as pandemic h n ⁄ in all eight segments. they were confirmed to be of pandemic h n ⁄ origin by subsequent full genome sequencing analyses, showing that there were interspecies transmissions of the virus from humans to pigs. , the remaining viruses had one to seven gene segments positive in the segment-specific real-time rt-pcrs. thirty of them were selected as representative samples for full genome sequencing analyses based on the genotyping data generated in our assays. they were swine h n or h n viruses with their gene segments derived from tr or eurasian avian-like swine lineages. it should be highlighted that all of their positive gene segments in our assays belonged to the sister groups of pandemic h n ⁄ . their melting curve patterns were very similar to those derived from segments of pandemic h n ⁄ , except for ha of tr lineage. our results successfully demonstrated the use of these segment-specific real-time rt-pcrs to recognize gene segments of contemporary tr (pb , pb , pa, ha, np, and ns) and ea (na and m) swine viruses. the ha-specific assay was able to discriminate pandemic h n ⁄ from other contemporary swine viruses in the same lineage. nevertheless, to confirm the identity and to examine all the genetic variations in the viruses of interest, full genome sequencing analyses were necessary. in this study, the biggest obstacles in primer design were sequence similarity and diversity of influenza viruses. we attempted to use degenerated primers, but they were highly non-specific. the finalized non-degenerated primers crossreacted with genes from pandemic h n ⁄ and its sister clade tr (pb , pb , pa, ha, np, and ns) and ea (na and m) swine viruses with some minor sequence mismatches. three avian (h n , h n , and h n ) and classical swine (h n ) were also tested with our assays. all of these animal viruses were negative, except for ns gene of the classical swine virus. our segment-specific real-time rt-pcr assays might be used in high throughput genotyping. they detected pandemic h n ⁄ viruses and acted as a preliminary screen-ing tool to select virus reassortants of interesting genotypes for further sequencing analyses. in fact, we identified a novel reassortant in january during the course of this study. this sw ⁄ hk ⁄ ⁄ has a previously unidentified viral gene combination as shown in figure . it was confirmed to be a reassortant between pandemic h n ⁄ and other swine viruses in full genome sequencing characterization. it has a pandemic h n -like n gene, an ea-like h , and the other six internal genes derived from tr swine viruses. , the eight established real-time rt-pcrs can rapidly reveal the gene-origins of influenza viruses. we are currently using these assays in influenza surveillance in humans and other animals. it is believed that similar strategy might be applied to detect and genotype other influenza viruses and possible reassortants in the future. pandemic influenza a ⁄ h n ⁄ infects millions of people around the world. a significant fraction of the world's population may also already have been exposed to the virus and, although asymptomatic, may be at least partially immune to the disease. a precise assessment of the number of people exposed to the influenza a ⁄ h n ⁄ virus is epidemiologically relevant. however, assays typically used to estimate antibody titers against a particular influenza strain, namely hi and neutralization, require use of the actual virus. this seriously limits broad implementation, particularly in regions where high biosafety facilities are unavailable. we developed an elisa method for the evaluation of presence of specific h n influenza virus-antibodies in serum samples. mouse anti-histidine tagged antibodies ( ll; lg ⁄ ml; abd serotec Ò , uk) in pbs (ph ae ) were dispensed into standard -well plates and incubated for - hour at room temperature. excess antibody was removed by at least two successive alternate washings with pbs-tween ae % and pbs. commercial blocking solution ( ll, superblock Ò t ; pierce Ò , usa) was added and incubated for at least hour at room temperature. after successive washing steps with pbs-tween ae %, non-glycosylated histidine-tagged recombinant protein ( ll; lg ⁄ ml) was added to each well. this protein consisted of the receptor-binding domain of the hemagglutinin of the influenza a ⁄ h n virus. , after hour incubation, wells were washed for at least two alternating minutes cycles with pbs-tween and pbs. a : dilution of the serum or plasma sample to be assayed ( ll) was added to each well and incubated at room temperature for hour. after repeated alternating minutes pbs-tween ae % and pbs washes, anti-human igg antibody solution ( ll ⁄ well; : dilution in pbs-tween ae %) marked with horse radish peroxidase (pierce Ò , usa) was added and incubated for hour at room temperature. after repeated alternate washes with pbs-tween ae % and pbs), substrate solution ( ll; -step ultra tmb-elisa; pierce Ò ) was added to each well. after incubation for minutes at room temperature in darkness, the enzymatic reaction was stopped by addition of m h so ( ll ⁄ well). yellow color produced by the enzymatic reaction was evaluated by absorbance at nm in a biotek Ò microplate reader (usa). blank assays using albumin in place of human sera established the elisa background signal, which was subtracted from sample absorbance signals: abs serum sample ¼ abs serum sample before correction À abs albumin sample : absorbance values were normalized based on the average signal of non-exposed subjects (uninfected subjects), and expressed as normalized absorbance (abs norm ): where abs serum ample is the sample absorbance signal, abs albumin sample is the albumin control absorbance signal, abs non exposed subjects is the average absorbance signal of non-exposed subject samples. for ferret serum samples, the same basic protocol was followed, with minor modifications. an anti-igg anti-ferret polyclonal antibody preparation was used at a dilution of : in pbs-tween ae %. a recombinant receptor-binding domain of the ha of the influenza a ⁄ h n ⁄ virus, expressed in escherichia coli strains, was used as the elisa antigen. this kda protein, designated here as ha - -rbd, contained amino acids - of the influenza a ⁄ mexico ⁄ indre ⁄ (h n ) hemagglutinin. a sequence coding for a series of six histidines at the n-terminus of the protein was included in the genetic construct to allow purification using immobilized metal affinity chromatography (imac) and attachment to assay surfaces treated with anti-histidine antibodies (or alternatively co + or ni + ). a panel of four samples (kindly provided by st. jude from ferrets exposed to different influenza strains, namely h n , h n swine, and h n , was also tested by the elisa method using : dilutions. protein ha - -rbd specifically and selectively recognizes antibodies from serum samples from convalescent h n ⁄ influenza subjects. dubois et al. demonstrated that this protein, produced in e. coli, folds properly into a -d structure practically indistinguishable from the analogous region in the ha of the influenza a ⁄ h n ⁄ virus. ha - -rbd preserves three of the conformational immunogenic epitopes (sa, sb, and cb) described for influenza a ⁄ h n hemagglutinins. the recombinant protein was used as the antigen, attached through histidine tags to microplate surfaces treated with anti-histidine antibodies to discriminate between serum samples from subjects exposed and non-exposed to influenza a ⁄ h n ⁄ . samples collected before the pandemic onset, and therefore presumed to exhibit low specific antibody titers against influenza a ⁄ h n ⁄ , were analyzed by elisa using the antigen ha - -rbd. the histogram of normalized absorbance values from this sample set displayed a normal behavior with a standard deviation of ae units. only ae , ae , and ae % of these samples exhibited normalized absorbance values higher than ae , ae , and ae , respectively. no sample from non-exposed individuals presented an absorbance value higher than ae . variability among samples from non-exposed subjects was much lower than in samples with high specific serum antibody titers from convalescent h n ⁄ patients. exposure to the h n ⁄ influenza virus with this elisa method can be predicted by absorbance values normalized to those of abs norm ¼ ðabs serum ample À abs albumin sample Þ=ðabs non exposed subjects À abs albumin sample Þ ð Þ serum from uninfected subjects. consequently, for reliable results, inclusion of samples from non-exposed subjects on every assay microplate is necessary. figure shows the analysis of human serum samples, including samples from convalescent patients with positive diagnosis by rt-pcr. three positive (dark gray bars) and two negative controls (light gray bars) were included in the same microplate. all serum samples corresponding to convalescent subjects exhibited absorbance values ae - ae times higher than negative samples ( figure ). normalized absorbance values above ae suggested exposure to the virus, although, a more conservative threshold value of ae units is proposed for discrimination between exposed and non-exposed subjects. the elisa method described here yields adequate reproducibility and a high signal ⁄ noise ratio within determinations in the same microplate and among different microplates. using a normalized absorbance value of ae , the method was able to discriminate samples from convalescent patients, preferably after the third week of infection, and at least up to the twentyfourth week of exposure. assay sensibility was further validated against results from hi assays. a previously reported study showed that all members in a pool of fourteen samples diagnosed as positive by hi exhibited normalized absorbance values higher than ae , and % of them exhibited normalized absorbance values higher than ae . in general, high hi titers (> ) were correlated with normalized absorbance values higher than ae . figure a shows results using the ha-rbd elisa method and the hi assay on a pool of seventeen known positive serum samples corresponding to convalescent h n ⁄ patients. all samples determined as positive by hi ( samples) were also positive by elisa. while sensitivity of the hi assay was ⁄ = ae %, the elisa method recognized all samples correctly as positive ( % sensitivity) when a threshold of ae or ae was used. figure b shows that sera from ferrets infected with other influenza strains (h n , h n swine, and h n ) showed no cross-reactivity when analyzed by elisa. in summary, the ha-rbd elisa method presented here consistently distinguished influenza a ⁄ h n ⁄ infected and non-infected individuals, particularly after the third week of infection ⁄ exposure. since no actual viral particles are required, this assay can be readily implemented in any basic laboratory. in addition, should sufficient vaccine be unavailable, this elisa could determine the level of specific antibodies against the virus and presumably the extent of partial protection in a subject. therefore, the elisa protocol might allow better administration of vaccination programs during pandemic or seasonal influenza outbreaks. in april , a novel h n influenza virus emerged in north america and caused the first influenza pandemic of the st century. [ ] [ ] [ ] [ ] the pandemic h n (pdmh n ) has a unique gene constellation that was not previously identified in any species or elsewhere. it is genetically related to the triple reassortant swine h n influenza viruses currently circulating in north america, with the exception of the neuraminidase (na) and matrix (m) genes, which are derived from a eurasian swine influenza virus. swine h n influenza viruses were first isolated in and continued to circulate in north america with very little antigenic changes (classical swine h n ) until . since , however, the antigenic make up of swine h viruses has shown increased diversity due to multiple reassortment events and the introduction of h n genes from human influenza viruses. currently, four swine h clusters (a, b, c, d) are found endemic in the north american swine population. , these swine h viruses show substantial antigenic drift compared to the classical swine h viruses. cluster d swine h is derived from current human h viruses, and there is a substantial antigenic divergence between classical swine h and human seasonal h viruses. epidemiological evidence shows a two-way transmission of influenza viruses between swine and humans, and such events lead to the emergence of the pdmh n virus. , , phylogenetic analysis have suggested that possible ancestors of the eight genes of pdmh n were circulating in the swine population for at least years prior to the emergence of the pdmh n virus in humans, although the pdmh n virus itself was not isolated from pigs until after the pandemic. interestingly, pdmh n infections have been reported not only in humans and pigs, but also in other animal species such as turkeys, cats, ferrets, cheetahs, and dogs. [ ] [ ] [ ] after the first report of pdmh n infection in swine in canada, other countries, including argentina, australia, singapore, northern ireland, finland, iceland, england, united states, japan, and china reported outbreaks of pdmh n in swine as well. , [ ] [ ] [ ] the ample geographic range of pdmh n outbreaks in swine, its apparent broad host range, and the possibility of two-way transmission between swine and humans poses a tremendous challenge for controlling the virus. therefore, to differentiate pdmh n from other h strains, particularly in swine and human populations, is an important issue to ascertain the magnitude of the disease caused by the pdmh n . in this study, we developed an elisa assay to discriminate pdmh n strains from other swine and human h viruses. madin-darby canine kidney (mdck) cells (atcc, manassas, va, usa) were maintained in modified eagle's medium (mem) containing % fbs. a ⁄ california ⁄ ⁄ ⁄ h n virus (ca ⁄ ) was kindly provided by the centers for disease control and prevention (cdc), atlanta, georgia. other viruses are listed in table . viruses were propagated in mdck cells and stored at ) °c until use. viruses were titrated by the reed and muench method to determine the median tissue culture infectious dose (tcid ). three monoclonal antibodies ( b , h , and f ) against ha of pandemic h n were prepared in our laboratory following previously described methods (shao and perez et al., unpublished). purification and labeling of mabs mab b , h and f were purified on a protein g-sepharose affinity column (upstate biotechnology, lake placid, ny, usa). biotinylation of the detection antibody in the elisa was performed using sulfo-nhs-lc-biotin (sulfosuccinimidyl- -(biotinamido)hexanoate; pierce, rockford, il, usa) according to the manufacturer's instructions. purified h and f were selected as the capture antibody, and biotin-conjugated b was selected as the detection antibody, and hrp-conjugated streptavidin (abcom, cambridge, ma, usa) was developed using the tmb substrate system (kpl, gaithersburg, md, usa). in brief, the mixture of the purified h and f ( ae and ae lg ⁄ ml respectively, in carbonate ⁄ bicarbonate buffer, ph ae ) was coated to -well plates (test well, t) for h at °c. at the same time, a control antibody was coated to -well plates (control well, c). after blocking the plates with % (w ⁄ v) non-fat milk in pbs for hour at °c, the samples were diluted in extract buffer ( %tween- , ae %bsa in pbs) and added to the wells ( ll ⁄ well, each sample was table . specificity assay of the sandwich elisa result (t ⁄ c) added to four wells-two for t wells and two for c wellsand the mixture was incubated at °c for hour. after four washes, ll biotin-conjugated b ( ae lg ⁄ ml) in dilution buffer ( ae % bsa in pbs) was added to the wells and the mixture was incubated for h at °c. following three washes, ll diluted hrp-conjugated streptavidin ( ae ng ⁄ ml) in dilution buffer was added to the plates. after incubation for h at °c, the plates were washed five times, and the binding developed using the tmb substrate system for minutes. the ratio of the average od value of the t wells to that of the c wells (t ⁄ c) of individual samples was calculated. t ⁄ c values > ae were considered positive in the sandwich elisa. we developed three monoclonal antibodies, b , h , and f , against a prototypical pdmh n strain, a ⁄ california ⁄ ⁄ (h n ) (ca ⁄ ). these monoclonals were used to develop a rapid sandwich elisa for specific diagnosis of pdmh n strains. purified h and f were used as capture antibodies, whereas the biotin-conjugated b was used as detection antibody. the sandwich elisa showed strong reaction with different pdmh n strains as described in in order to evaluate if the sandwich elisa could distinguish the pdmh n from other swine h clusters (a, b, c, d), swine influenza strains spanning these clusters were tested. these viruses were first diluted : in extract buffer, and then added to the coated plates. as shown in table , the t ⁄ c ratios of these viruses were < ae , and therefore showed negative elisa result. likewise, testing of human seasonal virus strains a ⁄ brisbane ⁄ ⁄ (h n ), a ⁄ malaya ⁄ ⁄ (h n ), a ⁄ wsn ⁄ (h n ), and a ⁄ brisbane ⁄ ⁄ (h n ) also showed negative elisa results. furthermore, the sandwich elisa showed no cross reaction with avian influenza viruses, including strains of the h , h , h , h , h , h , h , h , h , h , and h subtypes. more recently, the mutation d g in the ha of some pdmh n strains has been associated with exacerbated disease and altered receptor binding. [ ] [ ] [ ] [ ] [ ] to evaluate if such mutant could be detected in our sandwich elisa, we tested a mutant of a ⁄ netherland ⁄ ⁄ (h n ) carrying the d g mutation (engineered by reverse genetics). as described in table , our elisa could still capture the d g mutant virus and showed a positive reaction, which highlights the specificity of our assay for pdmh n strains, even those with mutations. to evaluate the sensitivity of the elisa, we used the serially diluted pdmh n viruses to determine the limit of detection (lod). as shown in table , in our elisa the highest positive dilutions of nl ⁄ and ca ⁄ were : and : , respectively. the lod of the sandwich elisa by tcid was ae · and ae · tcid ⁄ ml, for nl ⁄ and ca ⁄ , respectively. it is important to note that the t ⁄ c ratio from nl ⁄ and ca ⁄ viruses showed clearly a dose dependent effect, while the t ⁄ c ratio of a ⁄ swine ⁄ iowa ⁄ (h n ) did not show the same dependence and was always < ae , corroborating the high specificity of the sandwich elisa for pdmh n strains. although we did not compare our elisa with other current commercial rapid influenza detection kits, the lod of our elisa assay is similar to other commercial kits that detect human seasonal influenza virus. comparison of the sandwich elisa with the ''gold standard'' -virus isolation in order to further evaluate the feasibility of the application of the elisa to clinical samples, nasal wash samples ae · ^ )( ae ) )( ae ) )( ae ) )( ae ) )( ae ) )( ae ) )( ae ) )( ae ) -from ferrets, of those previously infected with ca ⁄ and shown positive by virus isolation, were tested. the samples were diluted : in extract buffer and then tested using the sandwich elisa. result showed out of positive samples by virus isolation were positive also by the sandwich elisa (sensitivity ae %). the samples tested that were negative by virus isolation were also negative in the elisa, indicating % specificity for our assay. these results show not only that our elisa has high compatibility with the virus culture method, but also indicates this application can be used for clinical samples. although real time rt-pcr targeting the ha gene has been used for specific diagnosis of pdmh n with high sensitivity, [ ] [ ] [ ] [ ] [ ] [ ] it is a method that requires manipulation of the sample to extract viral rna, and it is prone to crosscontamination during the pcr steps. in this study, we described a convenient sandwich elisa based on three mabs developed against the pdmh n strain. the elisa not only shows high specificity for pdmh n strain, but also shows great sensitivity. the elisa could distinguish pdmh n strains from human seasonal h and h viruses and, more importantly, from other swine h viruses. we must note that current rapid diagnostic tests cannot be used to differentiate pdmh n from swine or human h viruses. it is also worth noting that the sensitivity of commercial rapid antigen-based diagnostic tests for detecting pdmh n is lower than that for human seasonal influenza viruses. , a study by kok et al. showed that sensitivity of the current rapid antigenic tests for pdmh n is only ae %, whereas that for seasonal influenza a is ae %. chen et al. developed a dot-elisa and increased the sensitivity for influenza rapid antigen detection. however, the dot-elisa developed by chen cannot distinguish among subtypes. the lod of our elisa is between ae · to ae · tcid ⁄ ml, comparable to the lod of rapid diagnostic tests for human seasonal influenza viruses. compared to the ''gold standard''-virus isolation-our sandwich elisa showed ae % sensitivity using ferret nasal washes. our results highlight the potential application of our sandwich elisa for the specific diagnosis of pdmh n viruses. the timely and reliable laboratory evidences are vital factors for field epidemiologists trying to control outbreaks of infectious diseases and for the practicing clinicians to properly manage disease cases. therefore, analysis of new detection methods in comparison to the routine ''classical'' methods is essential to select new methods to be introduced into health service practices, especially in developing countries. in this study we have compared rt-rt-pcr detection of influenza viruses and direct fluorescent-antibody assay using r-mix hybrid cells (a &mv lu) with the ''classical'' cell culture methods in developing country settings. in this study, we analyzed nasopharyngeal swabs col- the detection of influenza h , h , b, and pandemic influenza (h )pdm virus-specific nucleic acids was performed by rt-rt-pcr in abi fast real time pcr system using primers recommended by cdc, usa, and super-scriptÔ iii one-step rt-pcr and platinum Ò taq dna polymerase kits (invitrogen). the cycling protocol was: minutes at °c, minutes at °c, and cycles of seconds at °c, seconds at °c. rapid detection of influenza infected cells has been performed by dfa using the infected hybrid cells of r-mix within hours after inoculation, according to the manufacturers instruction (diagnostic hybrids, inc., usa). the isolation of influenza viruses was performed on mdck cell culture by the protocol recommended by cdc, usa. we detected ( ae %) influenza virus-specific nucleic acid fragments from all tested samples by rt-rt-pcr. among the positive samples, there were ae % a(h n ), ae % a(h n ), ae % influenza b, and ae % a(h n )pdm with different distributions by time series in different age-groups. inoculation of the cell lines by rt-rt-pcr positive samples selected randomly has detected influenza virus in ae % ( ⁄ ) on mdck cell culture and % ( ⁄ ) on r-mix hybrid cell culture with varying distribution for different strains. in other words, mdck cell culture technique was better for isolation for pandemic influenza viruses and dfa using r-mix hybrid cell culture technique for detection of seasonal influenza viruses (table ) . average times needed for the final results for different methods were: hours for rt-rt-pcr, hours for dfa on r-mix and days for mdck cell culture with two passages at least. the peak of the seasonal influenza a virus detection occurred in the - th weeks of , however the pandemic influenza detection peak was observed in the - th weeks of ( figure ). the outbreaks by seasonal influenza viruses was observed mostly among the children of - years of age, and pandemic influenza virus outbreak was observed mostly in the adults of - years of age. the results of this study indicate that rt-rt-pcr is the most suitable method for decision makers in epidemiological and clinical settings by sensitivity and timeliness. the final results show that r-mix dfa requires times longer, and by mdck cell culturing, times longer periods, than by rtrt-pcr. mdck cell culture technique has a higher isolation of pandemic influenza viruses, and r-mix dfa has a greater detection rate of seasonal influenza viruses by our results. according to our study, with rtrt-pcr, the isolation of positive samples by tissue culture of influenza a viruses was % and influenza b viruses was ae %, which is lower than in similar spanish study. however our study illustrates similar results with a canadian study where the sensitivity of dfa method and tissue culture technique was shown to be lower than rtrt-pcr sensitivity. as recorded by a study of american researchers, r-mix hybrid and conventional cell culture techniques have had similar sensitivity, which does not match the results of our study. however, the results of our study match with the results of italian and american scientists , where the r-mix hybrid method for seasonal influenza viruses is higher than mdck cell culture technique. background: viral kinetics is increasingly used to study influenza infectiousness. the choice of the study design, i.e. when and how many times nasal samples are to be collected in individuals depending on the sample size, is crucial to efficiently estimate the viral kinetics (vk) parameters. material and methods: we performed a model based optimal design analysis in order to determine the minimal number of nasal samples needed to be collected per subject and when to collect them in order to correctly estimate the vk parameters. the model used was a non linear mixed effect model developed with data collected from patients sampled nine times in days (initial design - samples collected), and we used d-optimization for design identification. we also computed the minimal number of participants necessary. results: considering that % of the influenza-like illness cases are not due to volunteer challenge studies have been used since the 's to provide data on virus shedding from the respiratory tract during influenza infection. recently, vk was studied in naturally acquired influenza infection. , these data are invaluable to describe the natural history of influenza-infection and to compute natural history parameters such as the latent period, generation time, or the duration of infectiousness. [ ] [ ] [ ] [ ] however, among the studies used in a meta-analysis about viral shedding kinetics, the designs varied greatly from one to another. these differences led to variable amount of available information concerning the vk. the lack of adequate sampling leads to imprecise estimates. on the other hand, intensive sampling or over-sampling, while associated with highly informative data, may lead to unnecessary discomfort for the patient and cost to the investigator. optimal design is increasingly used to conceive studies and provides cost-efficient designs. here we propose an optimised design to model vk in the case of influenza infection. we defined the number of participants, the number of samples to collect and their allocations. this design allows, at a minimum cost and discomfort, accurate vk curves and allows the natural history parameters to be well described. model a vk population model was proposed for influenza infection. this model describes with eight parameters the relations between free virus, uninfected target epithelial cells, infected epithelial cells, and early immune response. this model was built on a dataset of volunteers from which nasal samples were collected once a day over days. we call this dataset the ''original dataset''. three parameters, the induction of the early immune response, the virus production rate, and the virus clearance, did not show inter-individual variability and were precisely estimated (relative standard error below %). we considered them as fixed in this research work. five parameters were hence considered here: b the infection rate, d the infected cell mortality rate, w the effect of early immune response on virus production rate and v init the initial value of virus titre. in order to correctly estimate these parameters it is crucial to determine a design to collect informative data. optimal designs maximise the amount of information provided by the study. it involves the determination of the number and allocation of sample times per subject as well as the number of participants. d-optimization is based on the maximization of the determinant of the fisher information matrix and thus minimizes the variance of the parameters. we used the fedorov-wynn algorithm implemented in pfim . to maximize this determinant, which implies to pre-define a set of possible sample times. with the hypothesis that the inoculation occurred at : am, we chose three possible hours ( : , : , and : ) for each day with respect of the sleep-time. to validate the design, we simulated datasets of volunteers with the optimised design obtained. we then estimated the population parameters using monolix . for each of the datasets. we compared the estimated parameters obtained with the simulated datasets to the parameters used to build the optimal design. we computed the relative bias as: with n: number of successful estimations among the simulated datasets. h i : parameter value obtained with the ith dataset. h: parameter value obtained with the original dataset. we also compared the observed rse from these simulations with the rse predicted by pfim and the rse obtained with the original dataset. the rse is proportional to ffiffiffi n p , where n is the population size. we can hence deduce the smallest number of participants necessary to obtain rse below %. where rse predicted is the highest predicted rse (here rse for w) with participants and n predicted = and rse min is equal to ae . considering that % of the influenza-like illness cases are not due to influenza virus, the total number of participants should be multiplied by ae . we found that the best design was when all the participants are sampled five times: three times during the second day post-inoculation at : , : , and : hours and twice on the third day post-inoculation at : and : ( figure ). the comparison of the relative bias and rse predicted by pfim and those obtained after simulation and re-estimation of the parameters are shown in figure . v init and d in a lesser extent present bias. fixed effect parameters are precisely estimated and accordingly to pfim except for v init . we found that participants shedding virus or participants with ili symptoms are necessary if % of them are not infected with influenza virus. we propose an optimised design to accurately study the vk of influenza virus with the minimal number of samples. this design is well balanced between the amount of necessary information and the precision of estimation. we found that samples are necessary to precisely fit the vk curves, which is five times less than the number of samples collected in the original study. ??? the samples should be collected during the second and third days after inoculation. yet we showed in a previous work that the incubation period lasted ae days. ??? hence, the optimised sample times correspond to the two-first days of symptoms and this design could be applied to naturally acquired infections studies in which the inoculation time is unknown. an advantage of this design is its practicality and convenience. all samples are collected during the daytime and after the onset of symptoms. it can thus be used for studies with naturally acquired infections. the design was validated with several criteria concerning the accuracy of the estimation with the optimised design. the parameters estimates were generally satisfactory. the parameter describing the effect of the early immune response on the virus production rate was, however, less precisely estimated (predicted rse = %), and the initial value of the viral titre was very different of the one obtained with the original dataset (bias v init on figure ). this is probably due to the fact that it was measured at day post inoculation, and that the inter-individual variability is much higher than at day . furthermore, d (the infected cell mortality rate) seems also to be biased. this may be due to the fact that three parameters were fixed. the model used was developed from experimentally inoculated healthy volunteers with low serum haemagglutinin antibody titre and with virus inoculation time at : am. the applicability of the design to naturally acquired infection would depend on the pathogenicity of the virus as well as pre-existing immunity and the relevance of challenge method to natural influenza acquisition. our design could be directly used to accurately study vk during influenza infections and would reduce the discomfort of patients and the cost of the experimentation. usefulness of a self-blown nasal discharge specimen for use with immunochromatography based influenza rapid antigen test introduction influenza rapid antigen tests (irat) have become very popular and are widely used for confirming suspected clinical diagnosis of influenza in japan. most of the currently used irat that are based on immunochromatography (ic), nasopharyngeal swab, nasopharyngeal aspiration, and throat swab have been approved as specimens for japanese national health insurance purposes. but the specimen collection by these methods gives patients considerable discomfort, and sometimes appropriate specimens cannot be obtained due to patient resistance, especially by children. in the present studies, self-blown nasal discharge was used as the specimen for an irat, and the results were compared with the results of viral isolation and an identical kit primed with nasopharyngeal swab specimens for seasonal influenza viruses and pandemic (h n ) virus. patients who visited any of the clinics that belong to the influenza study group of the japan physicians association in the - and the - influenza seasons with influenza-like illnesses exhibiting findings were registered after providing informed consent. a square plastic sheet of · cm was handed to the patient. nasal discharge was collected by blowing the nose into the plastic sheet as a specimen for irat, i.e. self-blown specimen. two nasopharyngeal swab specimens were also obtained at the same time for irat and virus isolation. self-blown specimens were obtained successfully by ( ae %) of consecutive outpatients in the - season, as seen in table the sensitivity and specificity of various influenza rapid antigen tests have been reported in various settings. [ ] [ ] [ ] [ ] direct comparison of the results is difficult because of differences in patient or influenza virus, characteristics such as age, study designs, and other features. in this study of the - influenza season, the sensitivity, specificity, and accuracy of the ic kit primed with nasopharyngeal swab specimens were ae %, ae %, and ae %, respectively. these results were quite comparable to our results of the - season, in which the overall results of other ic kits were ae %, ae %, and ae %, respectively, indicating that the ic kit used is quite reliable. the sensitivity, specificity, and accuracy of an ic kit will vary by the method of specimen collection. in general, virus titer is considered to be highest with nasopharyngeal aspiration, lower with nasopharyngeal swabs, and lowest with throat swabs. practically, nasopharyngeal swab is the most popular. the sensitivity, specificity, and accuracy of the ic kit with self-blown discharge specimens compared well with those of an identical ic kit primed with nasopharyngeal swab specimens. for self-blown specimens, sensitivity and specificity were ae % and ae % for influenza a, ae % and ae % for influenza b, % and ae % for pandemic (h n ) . self-blown specimens display sensitivity, specificity, and accuracy comparable to that of conventional nasopharyngeal swab specimens. there was no significant difference in sensitivity, specificity, or accuracy between self-blown specimens and nasopharyngeal swab for influenza a, influenza b, and pandemic (h n ) . these results suggest that selfblown specimens are as useful as nasal cavity swab specimens for the diagnosis of influenza in the clinical settings. nasal discharge, obviously, cannot be collected from infants incapable of blowing their own nose or patients who do not develop a nasal discharge. in this study, self-blown specimens were obtained from ae % of the patients. the rate of successful collection was over % in the age groups of - and - years. these rates would seem to be sufficient for clinical use. the procedure of self-blown specimen collection using a plastic sheet is easy and causes no pain or discomfort. it seems to be more acceptable and safe than the other methods, especially for children. furthermore, this procedure reduces the risk of influenza transmission from patients to the medical staff members involved in sample collection. self-blown sample collection may be superior to other sample collection methods in these respects. we previously reported an inverse correlation between the amount of virus in a specimen and the time to a positive reaction. in this study, there was no significant difference in the mean time to a positive between self-blown self-blown specimens enough to be examined were obtained from consecutive outpatients, and specimens showed a tendency to be obtained large amount from children rather than the aged. there were no statistically significant differences between the ic kit results primed with self-blown discharge and nasopharyngeal swab specimens for influenza a, influenza b and pandemic (h n ) . and nasal swab specimens, suggesting that the self-blown specimens contained sufficient viral antigen for the ic kits. the influence of the presence or absence of nasal congestion on the results of the kit was assessed. the sensitivity of selfblown specimens from patients with nasal congestion was significantly lower than that from patients without nasal congestion. it is possible that insufficient capability to blow the nose due to nasal congestion might tend to lead to false negatives. the observation that the time to positive is longer for patients with nasal congestion than for patients without nasal congestion is concordant. application of self-blown specimen collection only to appropriate patients would increase the sensitivity, which would be important in a clinical setting. we tested only two commercial antigen detection kit, the quick vue rapid sp influ kit and quicknaviÔ-flu (denka-seiken co., ltd). the resulting sensitivity, specificity, and accuracy of the ic kit primed with self-blown specimens were considered adequate for clinical use. to confirm the usefulness of self-blown nasal discharge specimens, further investigation is necessary using other kits and in different settings. the usefulness of a self-blown nasal discharge specimen for an influenza rapid antigen test based on immunochroma-tography was evaluated in the - and - influenza season. results suggest that self-blown nasal discharge specimens are useful as specimens for influenza rapid antigen tests based on immunochromatography for not only seasonal influenza viruses, but also pandemic (h n ) virus. the specimen collection by the patients themselves will reduce the burden of other collection methods and the risk of infection to the medical staff. in april , a mixed-origin h n influenza virus was recognized as a new causative agent of influenza-like illnesses (ili) in humans. since its emergence, the virus has spread rapidly throughout the world and caused a pandemic. most commercial rapid antigen tests (rat) can detect influenza a or b viruses, but cannot specifically distinguish pandemic (h n ) virus with seasonal influenza. recent studies have indicated that the poor performance of the rat approach and nonspecific detec-tion of the pandemic (h n ) virus was the main obstacle to their widespread use in private clinics. , with the need for a new rapid kit with reasonable sensitivity and specificity for pandemic (h n ) virus, we developed a new rat kit in collaboration with company, standard diagnostics, inc., (yongin-si, gyonggi, korea). monoclonal antibody (mab) against haemagglutinin (ha) of the pandemic (h n ) virus was developed using korean isolate and applied to the new kit with the mab to seasonal influenza virus. we examined the detection limit of the kit using the serial dilution of korean pandemic virus isolate (a ⁄ korea ⁄ ⁄ ). during december , clinical specimens from patients with ili were collected at sentinel clinics of six provinces in korea. the specimens were tested by the new rat, and the results were compared with those of real-time reverse transcription polymerase chain reaction (rrt-pcr) by us cdc and virus isolation in mdck cell culture to determine the sensitivity and specificity for the diagnosis of pandemic (h n ) . the detection limit of the new kit against ha of a ⁄ korea ⁄ ⁄ virus was confirmed to be pfu ⁄ ml. by contrast, the detection limit against the np protein was pfu. however, when the kit was applied to clinical specimens, no difference between the two targets was found. using rrt-pcr and viral culture as the references, the performance of the ridt is shown in table . among specimens, were tested positive by rrt-pcr and were tested positive by viral culture. among the rrt-pcr confirmed cases, were positive, and among the viral culture confirmed cases, were positive with the new rat. using rrt-pcr as the reference standard, the overall sensitivity of rat was ae % ( % confidence interval (ci): ae - ae %) and specificity was ae % (ci: ae - ae %). with viral culture as the reference, the rat sensitivity and specificity was ae % (ci: ae - ae %) and ae % (ci: ae - ae %), respectively. when analyzed by the regions tested, the sensitivity ranged between ae % and ae % for rrt-pcr and between ae % and ae % for viral culture as a reference. among patients who had a record of their symptom onset and sample collection date, ( ae %) visited the clinic on the day of symptom onset, and ( ae %) visited day later. when the rat performance was evaluated by day of onset, the sensitivity was lower at three or more days after the onset of symptoms; however, the sensitivity was highest at days after onset and reasonable on the day of onset or at day after ( table ). we found that this new rat had reasonable sensitivity and high specificity compared with rrt-pcr and viral culture for detecting the pandemic (h n ) virus. in one recent study, the sensitivity and specificity of the new rat kit was % and %, respectively, and the ha protein for pandemic (h n ) was detected more sensitively than the np protein for influenza a virus. the sensitivity and specificity of our new rat were lower than those of that study. we found that the test performance varied depending on the clinics in which the tests were performed, and this might be attributable to the persons who collected the specimens. although the clinicians were trained well for *ci, confidence interval. **ppv, positive predictive value. ***npv, negative predictive value. collecting specimens, there might be some differences in performance. the new rat kit could detect pandemic (h n ) virus specifically. although the sensitivity was lower than those of rrt-pcr and virus culture, and negative rat results should be confirmed with more sensitive methods, this kit could be useful in sentinel clinics if used with caution. determination of infectious virus titres is central to many experiments designed to study the biology of influenza virus. assays based on the measurements of viral components, whether viral protein or nucleic acid, does not differentiate infectious virus from non-infectious or defective viral particles, which may have no infectivity or biological *three hundred and forty samples with a known date of onset and sample collection were analyzed. ª blackwell publishing ltd, influenza and other respiratory viruses, (suppl. ), - activity. therefore the ''gold standard'' of virus measurement requires bioassays that examine the ability of viral particles to replicate and further infect other cells. titration on madin-darby canine kidney (mdck) cells in a well plate format is commonly used to measure influenza virus titre. this method is labour intensive, subjective in their read out of cytopathic effect, and takes several days to obtain a result. microneutralization tests that quantitate neutralizing antibody titres and assays of drugs for antiviral activity also require well based assays of residual virus infectivity. therefore, technologies that improve on the titration of infectious virus will be of great benefit. this study utilized the xcelligence system (roche applied science), which adopts microelectronic biosensor technology to monitor dynamic, real-time label free and non-invasive analysis of cellular events. the system measures electronic impedance using an array of microelectrodes located at the bottom of each culture well (e-plate ). adherent cells are attached to the sensor surface of electrode arrays, and changes in impedance can be detected and recorded. the xcelligence system can monitor cell events induced by viral infection, such as changes in cell number, adhesion, viability, morphology, and motility. measured electrode impedance is expressed as dimensionless cell index and is graphically represented using software to show the phenotypic changes of a cell population over time. the aim of this study is to demonstrate that using this platform to measure real-time cell index has potential to circumvent many of the limitations of the currently established procedures of end point titration of virus infectivity and for microneutralization assays. madin-darby canine kidney cells were propagated in growth medium consisting of minimum eagle's medium (invitrogen) supplemented with % fetal bovine serum (invitrogen), ae mg ⁄ l penicillin (invitrogen), and mg ⁄ l streptomycin (invitrogen), with incubation at °c in a % co humidified atmosphere. influenza a ⁄ hong kong ⁄ ⁄ (h n ), a seasonal influenza virus from a patient who suffered from a mild febrile illness, was propagated in mdck cells maintained in virus medium consisting of minimum eagle's medium (invitrogen) supplemented with ae mg ⁄ l penicillin (invitrogen), mg ⁄ l streptomycin (invitrogen), and mg ⁄ l np-tosyl-l-phenylalaninechloromethyl ketone-treated trypsin (sigma, st louis, mo, usa), with incubation at °c in a % co humidified atmosphere. virus stocks were aliquoted and stored at °c until use, and the % tissue culture infectious dose (tcid ) of the virus stock was determined by titration in mdck cells according to standard procedures, and the tcid of the stock virus was calculated by the method of reed and muench. to perform a microneutralization assay, mdck cells seeded at a density of cells ⁄ well in an e-plate was removed from the xcelligence system after approximately hour; growth medium was then removed, cells washed, and replaced with ll virus-medium. a human serum, which is known to contain high titre antibody against the h n virus was heat inactivated for min at °c, and twofold serial dilutions were performed in virus medium. the diluted serum was mixed with an equal volume of virus medium containing influenza virus at tcid ⁄ ll. after incubation for h at °c in a % co humidified atmosphere, ll of virus-antibody mixture was added to the mdck cells to give each well an equivalent virus dose of tcid . a back titration of the virus challenge dose was performed, and a cell control (free of virus) was performed in quadruplicates. after incubation at room temperature for minutes, the e-plate was then placed back onto the xcelligence system in the incubator and maintain at °c with % co , and the cell index values were measured every minutes for at least a further hour. the same procedures were performed with cells seeded in conventional well cell culture plates for parallel comparison with the currently used standard method. in this case, cells were examined for cytopathic effect under an inverted microscope after days of infection and the lowest virus dilution, which protected the cells from viral induced cytopathic effect taken as the neutralizing end point. after hour of seeding mdck cells at cells ⁄ well, standard microneutralization assay for influenza virus was performed. integral to this assay, a serial titration of the input virus at ae log increments was carried out. wells infected with the undiluted virus ( tcid ⁄ well), the cell index commenced dropping at a steeper gradient than the no-virus cell control after approximately hour of infection ( figure ). this drop in cell index continues at a consistent slope until it flattened out when approaching zero cell index. this steep decrease in cell index with constant gradient was also observed for virus dilutions up to and including log ( -folds), and the profile shifted with increased time in proportion to the dilution made to the virus. virus dilutions beyond log have cell index profiles similar to the no virus input control, and this corresponds to the absence of cytopathic effect as determined by microscopic observation at hour after infection. hence, there was a correlation between the amount of virus used for infection, the onset of the influenza virus-mediated cytopathic effect, and the steep decline in cell index. a human serum with known microneutralization antibody titre to h n virus was used in this study to investigate the real time cell index changes that occur during the assay ( figure ). using influenza virus treated with serum dilutions up to and including a dilution of : , the cell index profile remained essentially the same as the no virus cell control, which correlates with the lack of cytopathic effects under microscopic observation at hour of infection. at a serum dilution of : , the steep decrease in cell index, which is characteristic of cellular cytopathic effect induced by the virus, became evident at around hour post infection, and this was reduced to hour when serum dilution of : was used. in contrast, for the virus -no antibody control, the onset time for this steep decrease in cell index occurs at approximately hour. for both serum dilutions of : and : , full cytopathic effect was observed microscopically at hour of infection. from microscopic observation of cytopathic effect, according to the current standard procedures, the neutralizing titre of the human serum used in this study is at : as it is the last dilution of the serum that prevented cytopathic effect from being detected. an essential part of the microneutralization assay is to confirm the titre of the input virus (normally tcid ⁄well) by performing a titration assay with decreasing serial dilutions of the virus. under normal procedures, cells are examined microscopically after hour of infection for sign of cytopathic effects. in the case of mdck cells, the cytopathic effect is cell death, which is indicative of the presence of live influenza virus infecting and replicating in the cells. therefore, the titre of the virus is taken as the last dilution in which cytopathic effect is present. parallel realtime cell index measurements demonstrated that for wells with cytopathic effects, the profile exhibits a steep gradient linear decrease in cell index after infection with the virus, which can be termed the ''cpe plunge.'' the time in which the cpe plunge became evident appears to be inversely proportional to the amount of virus, therefore the opportunity exists to utilize this aspect to calculate or compare quantitatively different virus concentrations. for unequivocal assignment of cytopathic effect, it normally requires - days after infecting the cells, with days after infection being the standard time to read virus titration and microneutralization assays. using the real-time cell index monitoring, it is found that apparent cytopathic effect can only be observed microscopically when the cell index has dropped to near zero. as the time of onset of the ''cpe plunge'' becomes evident many hours prior to observable cytopathic effect, it is possible that the time to results can be drastically reduced after some formulation of the method. we compared the current standard method in perfoming a microneutralization assay with one utilizing the real-time cell index measurement to investigate whether this approach is able to offer better performance over the existing one. the current standard neutralization assay is the microscopic observation of antibody mediated protection from virus cytopathic effect in mdck cells. this study showed that this may also be achieved by examining the profile generated from the real-time measurements of the cell index. using real-time cell index monitoring, it is possible to detect inhibitory activity at higher dilutions of the anti-serum than can be detected by the standard microscopic observation of cytopathic effect. therefore, the realtime cell index monitoring could potentially be developed to be a more sensitive method for measuring anti-viral activity. as drug resistant strains of influenza a viruses including the pandemic h n are being reported, the real-time cell based monitoring system may also have the potential to be developed for use as a diagnostic platform for drug resistance assays. this study suggests that real-time cell index monitoring has the potential to substantially reduce human resources in reading results, as well as reducing time-to-result of these assays from days to two. the saving could be substantial for work involving bio-hazard level ⁄ pathogens such as h n viruses as personnel working with these organisms are require to be highly trained and experienced. in addition, the reduction in transferring plates to and from the microscope in reading cytopathic effect will substantially reduce the possibility of accidents from occurring. furthermore, the system provides objective digital data to an otherwise subjective assay method, which can improve standardization, data exchange, and hence collaboration between different laboratories. with more detailed validation and development, real-time cell index monitoring could transform the way we study and diagnose infection with pathogens such as influenza viruses. the emergence of a novel h n influenza a virus of swine origin, the pandemic a(h n ) , with transmissibility from human to human in april posed pandemic con-cern and required modifications to laboratory testing protocols. a new protocol for universal detection of influenza a and b viruses and simultaneous subtyping of influenza a (h n ) virus, composed of two-one-step rt-pcrs, fast set infa ⁄ infb and fast set h n v (relab, italy), was evaluated and compared to the reference protocol recommended by who. fast set infa ⁄ infb was able to detect influenza a and b viruses circulating between and belonging to different subtypes and lineages, and no cross reactions were observed by either fast set infa ⁄ infb or fast set h n v. the who assay was found to have a slightly lower end-point detection limit ( ) dilution) in comparison to the new protocol ( ) ). specificity of the assays was % as assessed on a panel of stored clinical samples including adenovirus, respiratory syncytial virus, metapneumovirus, parainfluenza virus, s. pneumoniae, n. meningitidis, h. influenza, and human influenza viruses. the new assay panel allows the detection, typing, and subtyping of influenza viruses as requested for diagnostic and surveillance purposes. the high sensitivity of the protocol is coupled with capacity to detect viruses presenting significant heterogeneity by fast set infa ⁄ infb and with high discriminatory ability by fast set h n v. a rapid and sensitive assay for the detection of influenza virus in clinical samples from subjects with ili or low respiratory tract infections is a fundamental tool for epidemiological and virological surveillance, management of hospitalized patients, and control of virus nosocomial transmission. the emergence, in april , of a novel h n influenza a virus of swine origin, the pandemic (a(h n ) ), with transmissibility from human to human poses pandemic concern and required modifications to the laboratory testing protocols. molecular diagnosis of influenza is generally achieved through a twophase process: a screening phase for the detection of virus, and the subsequent strain characterization performed by either sub-type-specific rt-pcr or entire ⁄ partial genome sequencing. during a pandemic, simultaneous implementation of both the detection of influenza a and b influenza viruses and identification of the new subtype is useful for clinical and epidemiological reasons. here, we describe a new protocol including two-one-step rt-pcrs, fast set infa ⁄ infb and fast set h n v (relab, italy) that allows universal detection of all influenza a viruses and, simultaneously, all subtypes that are influenza a(h n ) . specificity and clinical sensitivity of the two-one-step rt-pcrs (fast set infa ⁄ infb and fast set h n v; relab, italy) were evaluated by testing selected specimens, including: • fifty samples collected from nasopharyngeal swabs representative of influenza viruses, belonging to differ-ent subtypes and lineages, and other respiratory viruses and bacteria circulating in italy between and . • six purified a(h n ), a(h n ), and a(h n ) strains, kindly supplied by alan hay, who influenza centre, london, uk. • two hundred-fifty influenza positive samples selected according to type, subtype, clade and viral concentration from > specimens received by the liguria influenza reference laboratory between january st and december st, . since , nasopharyngeal swabs sampled from patients suspected of having contracted the influenza virus have been collected in viral transport medium, and upon arrival into the laboratory, the samples were divided in ‡ aliquots. those not immediately processed were stored frozen at ) °c. stored samples were used for this evaluation, and all specimens were re-extracted for the study. samples collected between and included specimens positive for: no seasonal a(h n ) have been detected since january st, . furthermore, weak positive sample using fast set infa ⁄ infb, but negative at block pcr and typing ⁄ subtyping assays was tested. the analytical sensitivity of the test under investigation was determined testing ten-fold serial dilutions of seasonal influenza a(h n ), seasonal influenza a(h n ), new pandemic influenza a(h n ) , and b cell culture-grown viruses. the intra-assay reproducibility was measured by testing the same a(h n ) positive sample times in the same experiment, while the inter-assay reproducibility was confirmed by testing the same samples in independent experiments. to evaluate the performance of the protocol, all samples were tested using a block pcr confirmation test (seeplex Ò rv ace detection), and all specimens collected between january st and december st, and dilutions were also assayed using the recommended who ⁄ cdc protocol of real-time rtpcr for influenza a(h n ). typing and sub typing were performed using the who protocol and ⁄ or sequencing. viral rna was extracted from swabs using the qiaamp viral rna mini kit (qiagen) according to the manufacturer's protocol. fast set infa ⁄ infb and fast set h n v are two multiplex one-step real time pcr assays developed and evaluated by the liguria regional reference centre for diagnosis and surveillance of influenza in collaboration with relab diagnostics. both assays contain primers and a dual-labelled hydrolysis probe that targets two regions of the matrix gene (table ) . amplification conditions were as follows: reverse-transcription °c for minutes, denaturation °c for minutes, then cycles of °c for seconds, °c for seconds. the entire amplification process extended for minutes. an internal control real-time assay was also incorporated in order to detect pcr inhibition, failed extraction ⁄ pcr and technical error. the cdc realtime rtpcr (rrtpcr) protocol for detection and characterization of swine influenza includes a panel of oligonucleotide primers and dual-labelled hydrolysis (taqman Ò ) probes to be used in real-time rtpcr assays for the in vitro qualitative detection and characterization of swine influenza viruses in respiratory specimens and viral cultures. this protocol recommends three primer-and-probe sets: infa, amplifying a conserved region of the matrix gene from all influenza a viruses; sw infa, designed to specifically detect the nucleoprotein (np) gene segment from all swine influenza viruses and sw h , designed to specifically detect the hemagglutinin gene segment from a(h n ) . the seeplex Ò rv ace detection for auto-capil-lary electrophoresis is a multiplex block rt-pcr that applies dpoÔ (dual priming oligonucleotide) technology and is designed to detect major respiratory viruses, respiratory rna (influenza a and b virus, parainfluenza virus type , and , respiratory syncytial virus a and b, rhinovirus a ⁄ b, coronavirus oc and e ⁄ nl ) viruses and dna (adenovirus) virus, from patients' samples including nasopharyngeal aspirates, nasopharyngeal swabs and bronchoalveolar lavage. conventional viral culture was performed inoculating ae ml of each specimen into mdck-siat seeded into -well plates for influenza isolation. virus detection was performed by the hemagglutination test using ae % guinea pig red blood cells (rbc). specificity and clinical sensitivity results of the new protocol are reported in table . fast set infa ⁄ infb was able to detect influenza a and b virus circulating between and belonging to different subtypes and lineages, and no cross-reactions were observed by either fast set infa ⁄ infb or fast set h n v. among specimens collected between january st and december st, , all fast set infa ⁄ infb and fast set h n v high titre positive samples resulted positive using the who ⁄ cdc assay and showing reactivity using infa and sw infa primer-andprobe sets. among low titre a(h n ) positive samples at fast set infa ⁄ infb, ( ae %) were not detected by the who ⁄ cdc assay, but were positive using seeplex Ò rv . the who ⁄ cdc sw h primer-and-probe set works in ae % ( ⁄ ) and ae % ( ⁄ ) of high and low titre a(h n ) positive samples, respectively. all a(h n ) strains collected during and initially detected by fast set infa ⁄ infb were confirmed after rna re-extraction by seeplex Ò rv and who ⁄ cdc assay showing reactivity using the infa primer-and-probe set. all infa ⁄ infb were confirmed after rna re-extraction by seeplex Ò rv . one influenza a case identified by the who ⁄ cdc kit (infa primer-and-probe set, ct values: ae , sw infa primerand-probe set: negative) and new protocol (a primer-andprobe set, ct values: ae , a(h n ) primer-and-probe set, ct values: ae ) was not detected by either seeplex Ò rv or by who subtyping protocol and ⁄ or sequencing, suggesting a very low viral load or unspecific results by real time assays. the analysis of serial dilutions of cell culturegrown a(h n ) showed that the detection limit of fast set infa ⁄ infb, fast set h n v, and seeplex Ò rv was identical ( ) ) and log lower than that using the who ⁄ cdc protocol ( ) ). a similar analysis with respect to a(h n ) and a(h n ) strains indicated that fast set infa ⁄ infb sensitivity ( ) and ) , respectively) was log lower than that showed by seeplex Ò rv ( ) and ) , respectively). in comparison with the new protocol, the who ⁄ cdc assays, considering infa primer-and-probe set, was found to have a slightly lower end-point detection, detecting the ) a(h n ) and a(h n ) dilution. also in detecting influenza b virus, fast set infa ⁄ infb sensitivity ( ) and ) , respectively) was log lower than that showed by seeplex Ò rv and the who ⁄ cdc protocol. data on intra-assay and inter-assay precision, measured as cv% of ct showed that the dispersion indices observed had values of less than %. since samples were detected using the new protocol that resulted negative using the who ⁄ cdc assays. the unfortunately low quantity of low titre a(h n ) samples collected during did not allow us to highlight differences between assays fast set infa ⁄ infb, and fast set h n v positivity was always confirmed by seeplex Ò rv , which demonstrated high sensitivity, showing a detection limit comparable or lower when compared with those observed using the who ⁄ cdc assays. the high analytical sensitivity of seeplex Ò rv is reported by kim who observed a detection limit of copies per reaction for each type ⁄ subtype of influenza viruses. the high sensitivity of the new protocol is coupled with its capacity to detect viruses presenting a significant heterogeneity by fast set infa ⁄ infb and high discriminatory ability by fast set h n v. fast set infa ⁄ infb was able to identify representative influenza viruses of circulating strains during the last decade belonging to different subtypes, lineages, and clusters, and fast set h n v primerand-probe set reacted selectively with a(h n ) target. a recent report demonstrated that the sw infa assay is not specific to a(h n ) and is able to detect both human and avian (h n ) influenza a viruses and so there is the potential for misidentification. high titre (ct ae and ae at fast set infa ⁄ infb) a(h n ) viruses did not react with fast set h n v primer-and-probe set (data not shown). available human a(h n ) sequences are similar within the h n v primer-and-probe regions, but having - mismatches in the forward primer and, more notably, two of the mismatches occurred within nucleotides of the end, an important determinant for primer specificity. in conclusion, this protocol can be a powerful tool in the diagnostic laboratory setting for specific simultaneous analysis of several samples in minimal time, showing enhanced sensitivity in detecting influenza viruses, and high discriminatory ability in identifying the new pandemic a(h n ) . a university-corporate partnership to enhance vaccination rates among the elderly: an example of a corporate public health care delivery public health campaigns usually rely on governmental infrastructure and finance for vaccine implementation programs. however, there are many financial and physical barriers which preclude widespread and effective vaccine administration, especially among the elderly. on an international scale, both government agencies and citizen groups have a vested interest in searching for more resourceful methods of attaining significant immunization levels (> % of the population). in fact, it seems to have become both a grassroots civic and governmental goal, especially among developing countries. we implemented the unique strategy of enlisting the assistance of a privately-owned food market chain to address the public health issue of mass vaccination for the elderly. in this context, publix pharmacy and the university of south florida (usf) recently developed both a handbook and a training program to facilitate the administration of vaccinations. between and , the publix-usf partnership resulted in administration of over thirty thousand influenza a (h n ) vaccinations, % of which were given to adults over years of age. consequently, vaccine administration costs were decreased by using corporate resources and bypassing overly strained municipal resources. this unique university-corporate partnership successfully delivered h n vaccine to a vulnerable cross-section of society at a lower cost and with minimal side effects and morbidity. it may be safely projected that university-corporate partnerships could result in an effective method for rendering a vital service to an aging and especially vulnerable segment of the population. government policy and funding are the foundation of immunization programs on an international scale. for example, in the united states, governmental programs account for over % of the monetary outlay used for immunization. until , the global alliance for vaccines and immunizations (gavi) acted as a catalyst for implementing vaccine and immunization programs in each targeted country. under the auspices of gavi-collaborations between governments, charitable organizations, and multinational health agencies (such as uncief and the who)-many countries have increased their spending for vaccination programs. however, development of financially sustainable immunization programs geared toward reaching the majority of the population are still at a nascent level of evolution. the development of more innovative and costeffective approaches has become imperative in order to reach a greater number of vaccination candidates. administering the influenza vaccine only to the subpopulation of over year olds would save an estimated quality-adjusted life years in a cohort of approximately half the world's population. widespread public vaccination programs are made more complex by the continuing development of newer vaccines, concomitant specialized administration costs, and the logistical challenge of conveying recipients to vaccination points of service. , in spite of the increasing complexity of mass vaccination, cost-benefit analyses clearly favor annual influenza vaccination in the elderly population on an international scale. , recently, in , influenza vaccine administration was reported to reach between % and % of the elderly population, which denotes varying degrees of success within each particular country. , however, there was also a report of a uniform plateau effect at around % of the population, beyond which additional vaccination coverage was difficult to achieve. physical limitations to vaccination seem to be more insurmountable for the elderly. unfortunately, this is the population segment which could experience the most significant vaccination-associated mortality reduction. we employed the unique strategy of involving the resources of publix supermarkets, a corporate food market chain, to address the public health issue of widespread vaccination for the elderly. we took advantage of recent changes in the florida statutes, which expanded the scope of pharmacists' practice to include administration of vaccines. subsequently, publix pharmacy and the university of south florida (usf) developed a handbook and training program to facilitate and enhance vaccine administration by publix pharmacists. by using proprietary pharmacists and more practical supply storage, we were able to decrease the costs of vaccine administration. the consumer was charged $ for administration costs plus the cost of the injection itself, regardless of insurance or eligibility for governmental subsidy. although patients were initially self-selected, they were ultimately excluded if they had demonstrated prior adverse effects to influenza vaccinations or to any of the components of such vaccinations. between and , the publix-usf partnership vaccinated people against influenza a (h n ), of which were florida residents. the age range was - years old with a median age of years old. seventysix percent of the participants were over years old (see figure ). within the population surveyed, the reported side effects of the vaccine in this study were not serious, but included: vertigo, cold sweats, chills, vomiting, syncope, rash, nausea, stomach pain, elevated blood pressure, injection site reaction, inflamed bursa, and bilateral thigh discomfort. participants from all socioeconomic classes were vaccinated. an income-by-zip code analysis revealed % of those vaccinated resided in zip code areas where the average household income was <$ per year. of those remaining, % had an average income of $ -$ per year, and % had an income of >$ per year. each person vaccinated was charged ten dollars for administration costs. this represents a decrease in the administration costs ranging from one dollar to ten dollars saved per vaccine. , conclusion this unique university-corporate partnership successfully delivered h n vaccine to a high-risk population with decreased vaccine administration costs. the influenza vaccine is well-tolerated, with minimal side effects when patients who have a history of adverse reactions are excluded. we can postulate that university-corporate partnerships may indeed be effective at reaching the aging population which is a challenge in most communities. this delivery model may prove to be another tool for improving the efficiency of mass immunization by facilitating accessibility, which results in wider coverage. this model also enhances delivery of healthcare by decreasing costs of immunization regardless of whether the payer is a government, insurance company, or self-pay consumer. the gavi initiative stressed three goals for accomplishing sustainability and independence in immunization programs. the goals were to: (i) mobilize additional resources from governmental and non-governmental sources; (ii) improve program efficiency to minimize additional administration resources needed; and (iii) increase the reliability of funding. empowering privately owned corporations within the community, such as food markets or pharmacies, to administer vaccines mobilizes additional resources to readily achieve the first goal of gavi. mobilizing resources of non-healthcare, corporate vaccination locations enhances accessibility due to travel convenience. in our study, participants came from all socioeconomic classes, suggesting that ease of access is independently hindering mass vaccination, and that people of all incomes are more likely engaged when access issues are eliminated. the second and third goals were also accomplished by recruiting a corporation's resources for vaccine administration (refrigeration, storage, and employees). this minimizes the money spent from vaccine program funds to support the infrastructure of immunizations, thus improving financial efficiency and sustainability. financial efficiency implies that money is spent to safely reach as large a portion of the population as possible. by using corporate storage facilities instead of paying for independent facilities, money can be spent elsewhere. more vaccines can be purchased and more money can be spent on media communications to encourage vaccination. sustainability requires the ability to fund annual vaccination programs which reach % of the population or greater. key to the control of pandemic influenza are surveillance systems that raise alarms rapidly and sensitively. in addition, they must minimise false alarms during a normal influenza season. we develop a method that uses historical syndromic influenza data from the existing surveillance system 'servis' monitoring seasonal ili activities in scotland. we develop an algorithm based on wcr of reported ili cases to generate an alarm for pandemic influenza. wcr is defined as the ratio of the number of reported cases in a week to the number of cases reported in the previous week. from the seasonal influenza data from scottish health boards, we estimate the joint probability distribution ( figure ) we compare our method, based on our simulation study, to the mov-avg cusum and ili rate threshold methods and find it to be more sensitive and rapid. the wcr method detects pandemics in larger fraction of total runs within the same early weeks of pandemic starting than does any of the other two methods ( figure ). as shown in the table, for % pandemic case reporting rate and detection specificity of %, our method is % sensitive and has mdt of weeks, while the mov-avg cusum and ili rate threshold methods are, respectively, % and % sensitive with mdt of weeks. at % specificity, our method remains % sensitive with mdt of weeks. although the threshold method maintains its sensitivity of % with mdt of weeks, sensitivity of mov-avg cusum declines to % with increased mdt of weeks. for a two-fold decrease in the case reporting rate ( ae %) and % specificity, the wcr and threshold methods, respectively, have mdt of and weeks with both having sensitivity close to %, while the mov-avg cusum method can only manage sensitivity of % with mdt of weeks. the first cases of the pandemic were reported in scotland in the th week of the season. the wcr algorithm as well as the mov-avg cusum method detects the pandemic weeks later in week . the ili threshold method detects it week later in week . both the wcr and mov-avg cusum methods therefore outperform the ili threshold method by week in the retrospective detection of the pandemic in scotland. while computationally and statistically very simple to implement, the wcr method is capable of raising alarms rapidly and sensitively for influenza pandemics against a background of seasonal influenza. although the algorithm has been developed using the servis data, it has the capacity to be used at large scale and for different disease systems where buying some early extra time is critical. more generally, we suggest that a combination of different statistical methods should be employed in generating alarms for infectious disease outbreaks. different detection methods would provide cross-checks on one another, boosting confidence in the outputs of the surveillance system as a whole. real-time evidence being created worldwide will greatly contribute to the full understanding of influenza pandemics. here we report the real-time epidemiology and virology findings of the influenza a(h n ) pandemics in mongolia. the epidemiological and virological data collected through isss of nic, nccd, mongolia (real-time information on registered ili cases and virological laboratory results are available from the weekly updates in the nic, mongolia website: http://www.flu.mn/eng/index.php?option=com_ content&task=category&sectionid= &id= &itemid= ) were used for analysis in relation to the previous seasonal influenza activities in the country. influenza viruses were detected in naso-pharyngeal samples from ili patients by rt-rt-pcr with applied biosystems fast real time pcr system , using primers and instructions supplied by cdc, usa. influenza viruses were isolated by inoculation of rt-rt-pcr-positive samples of mdck cell culture according to the standard protocol. ten representative strains of a(h n )pdm viruses were selected for sequencing of different gene segments, namely: a ⁄ ula- , and a ⁄ dundgovi ⁄ ⁄ . sequencing of influenza virus gene segments was performed in applied biosystems xl genetic analyzer using primers and instructions supplied by cdc, usa, and bioinformatic analysis was performed with abi ⁄ seqscape v. . and mega programs. the pandemic alert in mongolia was announced by the government on april , , just after the who announcement of the pandemic alert phase, and planned containment measures were intensified. despite intensive surveillance, no a(h n )pdm virus was detected in mongolia until the beginning of october . around suspected cases, mostly arriving from the a(h n )pdm epidemic countries, tested zero by rt-rt-pcr for a(h n )pdm virus. the first a(h n )pdm case detected by the routine surveillance system in ulaanbaatar city, the capital of mongolia, was confirmed by rt-rt-pcr on october , ( st week of ). the reported ili cases escalated rapidly, reached the peak in the - th week of , and gradually decreased thereafter ( figure ). week of . however, the registered ili cases increased again from the th week of , and peaked at the - th weeks of . the viruses isolated during this nd peak were influenza b strains ( figure and table ). for the genetic characterization of the mongolian pandemic isolates, gene segments i (pb ), gene segments ii (pb ), gene segments iii (pa), gene segments iv (ha), gene segments v (np), gene segments vi (na), gene segments vii (m), and gene segments viii (ns) of the representative a(h n )pdm mongolian strains were sequenced, and all sequences have been deposited in the genbank (accession numbers: cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy , cy ). all genes of mongolian strains were possessing ae - ae % similarity with the genbank deposited gene sequences of the original pandemic strain a ⁄ california ⁄ (h n ). the who declared the pandemic alert phase (phase iv) on april , , and was prompted to announce the pandemic phase (phase v) two days later. after days, the who declared the beginning of the pandemic peak period (phase vi) on june , . however, in mongolia, the pandemic alert period continued for days. mongolia was free of the pandemic virus during the whole first wave of the pandemics in the northern hemisphere. with the confirmation of the st influenza a(h n )pdm case on october , in ulaanbaatar, mongolia entered into the pandemic phase (phase v), and after just weeks, the registered ili cases peaked, confirming mongolia shifted into the pandemic peak period (phase vi), which i i i v i i v i v v v i i i i iii iv v vi vii viii worldwide by who in mongolia coincided with the nd wave of pandemics in many countries of the northern hemisphere (see, picture and table ). despite the relatively milder clinical manifestations, the disease burden for the health service was enormous, while the morbidity per population at the peak period was - times higher above the upper tolerant limit, and - times higher above the seasonal influenza outbreaks. in contrast to the seasonal influenza outbreaks where over % of the registered ili cases have been in the age group under , it has been observed that over % of the registered cases in this pandemic peak period were in the age group of - . on january , , we regarded the pandemic had entered into the post-peak period (phase vii) when the registered ili cases became lower than the upper tolerant limit, during which time mongolia experienced an influenza b outbreak. on may , we determined that mongolia entered the post-pandemic period (phase viii) as the influenza virus isolations were almost stopped, and after no pandemic virus detected for months. who announced pandemic vii and viii phases much later. , this first ever real-time laboratory confirmed influenza pandemics in mongolia and confirmed some variations of pandemic spread in different parts of the world. the comparison of deduced amino-acid sequence changes have shown that the mongolian strains belong to the clade , according to the classification of a(h n )pdm influenza strains suggested by m. nelson, which has circulated worldwide since july . this is also evidence that the st wave of the pandemics did not hit mongolia. the who public health research agenda for influenza is aimed to support the development of evidence needed to strengthen public health guidance and actions essential for limiting the impact of influenza on individuals and populations. each stream-specific group reviewed and discussed the proposed organization, content, rationale, and global health importance of their designated research stream. specific research recommendations were made for topics within each stream: background: a syndromic surveillance system using nonclassical data sources for detection and monitoring evolution of flu and flu-like illness (ili) in djibouti is reported here as part of the preliminary report of djibouti who-copanflu international study (wcis)**. methodology: clinical reports, over-the-counter drug sales, lab diagnosis report, and health communication trends were obtained for an integrated statistical analysis. results: transition to winter is concomitant with upsurge of ili cases and ili drug sales. in addition, more rural folks manage ili infections on self medicament than through clinical consultancy. inefficient and vague data collections were observed. a successful implementation of wcis will create a platform upon which challenges faced in djibouti health department in routine surveillance will be addressed to achieve a near-real time surveillance of flu pandemic. conclusion: innovations, prompt reporting, and instituting open source syndromic surveillance system software's in resource limited environment like djibouti will enhance early detection and evolution monitoring of pandemic flu. the spanish flu in ⁄ infected and killed millions of people, and threatened to wipe humanity off the face of planet. however, the recent scenarios of influenza h n ( ) pandemics' worldwide occurrence fell short of most scientific prediction on its magnitude and intensity. this dampened their confidence; they cannot state precisely as to when, how, where, and which of the spanish flu-like pandemic will occur in the future. in support of scientific community and governments, the who hasn't gone to slumber, but is reminding its member states to up their post pandemic surveillance and monitoring of influenza virus in circulation for advance preparedness in case of an outbreak. despite all uncertainty around the pandemic flu h n , there remains a common knowledge and understanding that this flu has shown a great potential to evolve and cause huge morbidity and mortality. although its future magnitude may be unpredictable, its recurring events have severe consequences on human health and the economic well being of everyone. and therefore, advance planning and preparedness is critical in protecting any population in the future, especially those located in resource limited environment without universal health cover and generous disaster emergency funds. . two collapsed sets of a weekly and monthly mean data (of four years period) were clustered in five categories of ili cases, drug sales, lab results, vaccine consumption, and health promotion. this was followed by a descriptive statistics analysis of cumulative weekly and monthly data to establish presence or absence of trend. time series analysis was not done due to data limitation. copanflu program: as at the time of going to press, the cohort study is at the household recruitment and inclusion phase and the study covers the djibouti city. it is in our intention to use the cohort study findings to validate or improve the niph ministry of health djibouti ili surveillance effort for better preparedness. clinical service: % of all health facilities are in djibouti city. of the ae % ( ) of the population that seeks medical care on influenza and influenza like illness each year, ae % ( ) and ae % ( ) of them are attended to at the city's public and private clinics, respectively ( figure ). the rest are attended from the regional health centers. the majority of ili incidence sharply rise with the onset of the winter season (october to april), affecting mostly the middle age group ( - years). pharmaco-surveillance: % ( ) of total prescriptions were antipyretic and antiflu drugs, ae % ( ) of which were consumed by peripheral regions, the non dji- lab diagnostics: the annual ili lab diagnosis was negligible ae % ( ), which can be attributed to less equipped virology laboratories to warrant routine service utility. documented cases were from previous bouts of avian influenza that had a human incidence from and . with support of egypt-based naval army medical research unit three (namru ), clinicians were motivated to sample all ili patients and submit to collaborating international reference influenza lab in cairo, egypt. vaccination: influenza vaccinations were undocumented, but at least ae % ( ) of population sought the service (for yellow fever and meningitis) as mandatory travel advisory or as childhood immunization need. at the time of going to the press, there were at least vaccine doses of h n ( ) virus donations yet to be administered. health promotion and hygiene: print and audiovisual risk communication remained favorite means of reaching out to urban dwellers ( ae %). while to the rural and nomadic population, person to person communications was the preferable means. to increasing public awareness that will encourage reporting of ili cases and entrench risk aversion health behavior that limits flu spread, who-copanflu international study djibouti has incorporated basic training on ili infection and personal hygiene by interviewers during household inclusion. improving national epidemic surveillance capacity and response under new international health regulation is important for any nation, including djibouti. our finding indicates the winter season predisposes one to ili infections; they therefore opt for medical services or self medication depending on their capability and ⁄ or understanding. in djibouti, almost no city dwellers favors self medication over clinical consultation, suggesting the presence of inhibitory factors like distance from the health centers and the cost of accessing consultancy. common in the absence of universal primary health care setting, it therefore calls for active innovativeness in outbreak detection, disease reporting, and preventive medicine on the part of health authority so as to achieve good population health. in respond to these, niph has turned resource limitation to a motivation instead and is working towards institutionalizing a near-real-time syndromic surveillance system as a core functional unit. it capitalizes on three major aspects within its reach: prompt accurate data generation for analysis, ehesp wcic-study input, and information technology use. prompt accurate data generation for analysis: data used in our analysis suffered from un-timeliness (weekly instead of daily basis), incompleteness (vague over-counter drug sales records), entry errors (incidence case reports), and poor collection format (most of data collection forms). use of satellite handset phones for regional health centers and mobile phones for city sentinel clinics will reduce unnecessary data delivery delays. in addition, creating awareness to data entry personnel on the importance of careful and completeness of entries is important, as is the need to reformat data collection forms to capture exact aspects of surveillance needs for relevant executable analysis. besides alerting for immediate impending epidemics, these data can also be adopted for projective predictive modeling of annual epidemics, including that for influenza. ehesp wcic-study input: djibouti wcic-study is complementary to the existing syndromic surveillance system, but with emphasis on flu and flu-like illness. various innovations as suggested above are used in seeking to overcome the prevailing challenges. while every attempt is made to realize its (wcic-study) objective and for global comparison, lessons learned from successful implementation will form a platform for future refined syndromic surveillance protocol as equally reported elsewhere in asian countries. , information technology: national institute of public health djibouti has an informatics department with sufficient working pcs and personnel to execute efficient data collection and management for epidemiological analysis. however, licensing cost of near-real time syndromic surveillance software is prohibitive, but the open access software with capacity to generate custom graphs, maps, plots, and temporal-spatial analysis output for specific syndromes should make implementation a lot easier. such output for conditions like flu (or gastroenteritis) will be essential to cause prompt response of the local public health office and international partners in saving lives and suffering of djibouti people. pandemic flu surveillance and preparedness requires multifaceted, interdisciplinary, and international approach whose efficiency and efficacy can only be refined over time. building on the health care system's swot for preparedness, the ehesp wcic-study promises to refine surveillance system operation and knowledge on individual's risk determinants to swine flu (h n ) virus infection at the household level in djibouti. these efforts are ultimately creating available control options at the time of need (pandemic occurrence), and at the same time exploring investment in quality data profiling and information technology, which will include syndrome surveillance software systems like essence, ewors, or other open sourced ones. the antibody efficacy -which compares the illness frequency between those with and those without a protective level of pre-epidemic hi antibodies ( ‡ : ) -has been proposed ; however, this index has rarely been used due to practical difficulties in confirming the strain-spe-cific disease corresponding to each of the vaccine-induced antibodies. we followed elderly individuals residing in a nursing home, whose serum specimens were obtained before and after undergoing trivalent influenza vaccination, in ⁄ influenza season (medium-scale mixed [a ⁄ h n and b] epidemic in study area, and a ⁄ h n was circulating at the nursing home). the serum antibody titre to each strain of influenza virus was measured by the hi method, using the same antigens as those in the vaccine. all participants' body temperatures, respiratory symptoms, other general symptoms, hospitalization, discharge, and death were recorded daily from november to april in a prospective manner. when the participants suffered any influenzalike symptoms, such as sudden fever ‡ ae °c, throat swabs were collected and tested using a rapid diagnosis kit for influenza, which utilizes an immunochromatographic method. the adjusted odds ratios (or adj ) for febrile illness and kit diagnosed influenza were evaluated using multiple logistic regression models adjusting for possible confounders (i.e., age, sex, coexisting conditions, and vaccine strains). after vaccination, the proportion of subjects achieving an hi antibody titre ‡ : (seroprotection level) were ae % ( ae - ae %) for a ⁄ h n , ae % ( ae - ae %) for a ⁄ h n , and ae % ( ae - ae %) for b. during the follow-up period, the a ⁄ h n strain was isolated therein, and subjects experienced sudden-onset fever ( ‡ ae °c), and eight subjects were positive for rapid diagnosis kit. patients with a seroprotection level of the hi antibody titre ( ‡ : ) had lower incidences of febrile illness (or adj , ae ; % ci, ae - ae ) and rapid kit diagnosed influenza (or adj , ae ; % ci, ae - ae ) than those with a lower titre. thus antibody efficacy ( ) or adj ) against fever related to a ⁄ h n and kit diagnosed influenza were both estimated to be %. although statistical significance was not detected due to limited sample size, these results lend support for the usefulness of antibody efficacy. some data presented within this manuscript was also published in hara et al. asia via a regional network from which epidemics in the temperate regions were seeded. the virus isolates obtained from nasopharyngeal swab specimens from outpatients were typed and subtyped by the hemagglutination (ha) inhibition assay. the emergence of a ⁄ fujian ⁄ ⁄ coincided with higher levels of influenza-like illness in korea than what is typically seen at the peak of a normal season. most of the intermediates and fujian-like strains were isolated from asian countries, and the mutational events associated with the fujian strains took place in asia. closely dated phylogeny from december , to august , showed that the antigenic evolution of the h n fujian strains had periods of rapid antigenic changes, equivalent to amino acid changes per year ( figure ). the fujian-like influenza strains were disseminated with rapid sequence variation across the antigenic sites of the ha domain. the antigenic evolution of the fujian strains was initiated by exceptionally rapid antigenic change that occurred in asia, which was then followed by relatively modest changes. some of the data presented in this manuscript was previously published in kang et al. we compared reactivity to the novel virus strain using haemagglutination inhibition (hi) assays performed on discarded plasma specimens left over from routine testing. samples were taken from healthy adult blood donors (> years) before and after the ph n influenza epidemic that occurred during the southern hemisphere winter of , and again prior to onset of the southern hemisphere influenza season. reactivity to the novel h n strain of influenza was relatively uncommon among the healthy adult population during the first australian winter wave, rising from a baseline of % to %. a further increase in the seropositive proportion from % to % was observed over the summer months, most likely attributable to immunisation. this level of immunity appears to have been sufficient to constrain the winter epidemic. together with a final serum collection, planned for late , these data will aid evaluation of the extent and severity of disease in this 'second wave' of ph n . assessment of the extent of disease due to novel influenza a(h n ) virus (ph n ) during the winter outbreaks in australia was made difficult by the generally mild nature of disease. the epidemic was experienced in a staggered fashion around the country, reflecting the considerable geographical distances between state and territory capital cities ( figure ). differences in the intensity of case-finding during the evolving pandemic response and between jurisdictions hindered comparisons of disease burden in distinct geographical regions. rates of reported hospitalisations and deaths appeared fairly similar across states but, without a consistent exposure denominator, assessment of relative severity was difficult. we conducted a national serosurvey of antibody to ph n using residual plasma from healthy blood donors collected before and after the epidemic to estimate ph n exposure. here we report the findings of that first collection, together with new data on seroprevalence of ph n antibody in specimens gathered in march-april . these latter samples were collected prior to onset of seasonal influenza activity to assess the impact of a national ph n vaccine program conducted in spring ⁄ summer ⁄ on the proportion of individuals with antibody titres deemed protective. findings informed estimates of population susceptibility to ph n prior to the influenza season and provided a baseline for a subsequent serosurvey that will be collected at the end of to assess the extent of exposure during the 'second wave.' tralian red cross blood service (the blood service) for dengue fever surveillance studies. these samples were used to provide a baseline estimate of prevalence of cross-reactive antibody to ph n in the australian population. discarded plasma specimens, taken for virologic testing from healthy adult blood service donors, were prospectively collected at two additional timepoints for measurement of antibody to ph n . collection periods were as follows: approximately plasma samples were randomly selected from donors in each of brisbane, hobart, melbourne, newcastle, perth, sydney, and townsville on each occasion. up to specimens were identified in each of the following age strata: - , - , - , - , - , and > years. at the last collection timepoint, there was deliberate over-sampling of the oldest and youngest age strata in which approximately specimens were collected (i.e., up to specimens per site). in accordance with the provisions of the national health and medical research council's national statement on ethical conduct in human research, individual consent was not required for use of these specimens, given the granting of institutional approval by the blood service human research ethics committee. reactivity of plasma against ph n was measured in haemagglutination inhibition (hi) assays using turkey red blood cells (rbc). egg-grown a ⁄ california ⁄ ⁄ virus was purified by sucrose gradient, concentrated and inactivated with b-propiolactone, to create an influenza zonal pool preparation (a gift from csl limited). plasma samples were pretreated with receptor destroying enzyme ii (denka seiken co. ltd), : (volume ⁄ volume) and tested as previously described. following hour incubation, ll % (volume ⁄ volume) of rbc was added to each well. hi was read after minutes. any samples that bound to the rbc in the absence of virus were adsorbed with rbc for hour and reassayed. samples in which background activity could not be eliminated by these means were excluded from the analysis. titres were expressed as the reciprocal of the highest dilution of plasma where haemagglutination was prevented. a panel of control sera and plasma samples was included in all assays. it comprised paired ferret sera pre-and postinfection with the pandemic virus or seasonal influenza a(h n ), a(h n ), or influenza b viruses and paired human plasma and sera collected from donors before april or after known infection with the pandemic virus or after immunisation with the australian monovalent pandemic vaccine. all assays were performed by the who collaborating centre for reference and research on influenza. for each of the three study timepoints and within each age group, the proportion of seropositive individuals (hi titres ‡ ) was calculated, with exact (clopper-pearson) confidence intervals. the contribution of individual variables (age, gender) and location to seropositive status was assessed in separate multivariate logistic regression models developed to assess the post-pandemic and pre-influenza season collections. all statistical analyses were conducted in stata . locations of specimen collection are shown in figure , together with the number of samples tested from each centre. samples with high background hi titres or discrepancies between assays were excluded at each timepoint as follows: at baseline, from the post-pandemic collection, and in early . pared with baseline was % overall, rising from % to % (table ). the only jurisdictions in which seropositive proportions were higher in october ⁄ november than in the baseline collection were hobart [ % ( % ci ae , ae )], perth [ % ( ae , ae )], and sydney [ % ( ae , ae )]. in the multivariate regression model, the only jurisdiction in which exposure appeared somewhat higher than the reference population of brisbane was hobart [or ae ( % ci ae , ae ), p = ae ]. a marked age effect on antibody status was observed at this timepoint, with an increase in the proportion of seropositive individuals in relation to the baseline collection only noted for those aged between and years (table ) . according to the multivariate model, the youngest and oldest cohorts had similar titres, with all other groups showing significantly lower seropositive proportions than the reference population of - years [e.g. - years or ae ( % ci ae , ae , p < ae )]. an overall increase in the seropositive proportion from % to % was observed between october and april , distributed throughout all jurisdictions ( ( , ) ]. antibody titres prior to the influenza season rose in all age groups, but remained significantly lower among [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] year olds than in the youngest age cohort (table ) . adjusted ors for the seropositive proportion in the multivariate model in these age groups were: - years [or ae ( % ci ae , ae )]; - years [or ae ( ae , ae )]. the relatively low titres observed in these groups reflected small incremental increases in the seropositive proportion across each of the time points studied, suggestive of both low rates of infection and vaccination. the rise in immunity observed across the population was most likely attributable to immunisation in the majority, given the absence of observed outbreaks and very few notified cases of ph n during the period between the two plasma collections. this study suggests that, while adult exposure to ph n during the southern hemisphere winter was uncommon at around %, vaccine uptake in the australian population over the period november -may was in the order of %. this latter estimate is in keeping with recently published figures for adult ph n vaccine coverage from a national immunisation survey conducted by the australian institute of health and welfare. in that survey, vaccine coverage was significantly higher in tasmania than in other states, but mostly in those over years of age, possibly in a subgroup whose health status may have differed from that of the donor population. no allowance has been made in this analysis for likely waning of natural or vaccine induced immunity, possibly resulting in lower estimates of natural and ⁄ or vaccine exposure than may have occurred over the period. regardless of such intervening processes, the seropositive proportion among australian adults at the start of the winter season appeared likely to be sufficient to constrain transmission of infection in the age groups tested. this assertion has been borne out in practice, with only modest levels of influenza reported during the late and protracted season. a final serum collection is planned for the end of the influenza season in australia from which to assess the level of exposure in relation to the baseline observed here. the need for epidemiologic studies such as this has been highlighted by groups such as the european centre for disease control to aid evaluation of the extent and severity of the 'second wave,' known to be variable from historical reports of past pandemics in disparate populations. in - , the first wave of the swine-origin novel h n flu (h n ) pandemic swept across the world, including japan. to examine the epidemiological nature of this novel infectious disease among school children within and among small regional communities, we have carried out a complete survey on the incidence of h n among school children using absentee reports provided by school health teachers in two small administrative districts (population: about in total) in japan. we then examined the epidemiological diversity on the inci-dence of h n within and among small regional communities. we investigated seventeen elementary and ten junior high schools in moroyama-town and sakado-city located in the central part of saitama prefecture. populations are: all ages, and ; elementary schools, and ; junior high schools, and , respectively. the number of school children in each school ranges from to . the surveillance system was built on an apache-and mysql-based web server using html, php, and java-script. school health teachers enter information on children absenteeism due to school infectious diseases via web browsers at each school infirmary on a daily basis. in addition to the trend graphs shown on the web browser, detailed analyses were reported to the schools and local educational boards weekly. the basic reproduction number (r ) of h n was estimated according to becker. agentbased modeling and simulations were also performed using a multi-paradigm simulator anylogic version . (xj technologies, st. petersburg, russia). by the end of march , cumulative incidence (ci) of h n among school children in moroyama and sakado reached % and %, respectively. the overall r among school children in this area was ae . vaccination rate of children in this area during the surveillance period was reported to be very low (< %). there was no considerable difference between the epidemic curves in this neighboring town and city. on the other hand, in the individual schools, the cis as of the end of march scattered from % to % ( figure ) even though the schools are closely located. to examine the cause of this diversity, we built an agent-based community model consisted of the same numbers of agents as those of children in the actual schools and people in moroyama and sakado to simulate the infection. the ratio of probability of infection in schools and the remaining places were assumed to be : or : . using a heuristic optimization scheme, we estimated the parameters for the simulations to give the overall ci of % (the ci as of the end of march ). we then performed simulations repeatedly. the cis obtained with the repetitive simulations with the assumption of higher probability of infection in schools scattered from % to %, indicating that the cis of the small population communities may vary considerably, even though all the agents were assumed to have the same susceptibility to infection at the beginning, and the other conditions were the same. the policies for surveillance ⁄ analyses ⁄ prevention of communicable diseases in local communities have generally been decided on governmental-and ⁄ or each local administrative district-basis (populations: several hundred thousands to several millions) in japan. we found the considerable variations in the cis of h n for children among much smaller areas, i.e., the school districts (populations: all ages, several thousands; school children, several hundreds). we thus conclude that the granularity of surveillance ⁄ analyses ⁄ prevention should be finer than in the past to achieve the most effective policies against influenza and similar communicable diseases in the local communities. the cause of this diversity can be explained in part by the stochastic nature of infection transmission processes in the small populations shown by the agent-based simulations. we have already conducted a complete questionnaire survey for the school children and their parents to clarify the relevance of the other issues including differences in environmental factors, preventive policies (e.g., vaccination, school closures), etc., in each school. the detailed analyses will be reported elsewhere. a www-based surveillance system for transmission of infectious diseases among school children within and among small regional communities. j epidemiol ; (s ):s . this study confirms previous findings that age, pandemic influenza vaccination, and history of ili are associated with elevated post-seasonal gmt. this study also shows that seasonal influenza vaccination may have contributed to an increase of the hai titer, especially in the elderly. further analyses in this cohort are needed to confirm and explain these first results. the follow-up of subjects involved in the copanflu-france cohort will provide data to study the risk factors for infection by the influenza virus. the first cases of the a ⁄ h n v pandemic influenza were reported in mexico and the united states in april . given the context of this new influenza virus and considering the likelihood of its pandemic spread, the cohorts for pandemic influenza (copanflu) international consortium was created in order to study individual and collective determinants of pandemic a ⁄ h n v influenza across different countries by setting up prospective cohorts of households, followed during years. this study relies on the first available data from the copanflu-france project, which is part of the copanflu international consortium. we studied factors associated with elevated haemagglutination antibody titers against a/h n v at entry in the copanflu-france cohort. we focused in this primary analysis on the association between the titers and influenza vaccination (seasonal or pandemic) across age groups. the copanflu-france cohort was set up in fall . inclusions began on december , and ended on july , . households were sampled using a random telephonic design (mitofsky-waksberg method) in a stratified geographical sampling scheme, aimed at including a sample of subjects representative of french general population. all household members were eligible to the cohort, without any age limit. the inclusion of a household required the participation of all members: the refusal of one or more member(s) prevented the inclusion of other members. the protocol was approved by a research ethics committee and written informed consent was obtained for all subjects. this study requires several visits to the households by nurses who collect written data with questionnaires and biological samples. during the inclusion visits, nurses collected from all subjects detailed data regarding medical history, including vaccination and preventive measures against influenza. blood samples were collected at entry and centralized. a standard hai technique was adapted to the detection and quantification of antibodies to the a ⁄ h n v virus. the titration endpoint was the highest dilution that exhibited complete inhibition of haemagglutination in two independent readings. the lowest read dilution was ⁄ . geometric mean titers were calculated for hai assays with the use of generalized estimating equations for interval-censored data, , taking into account a within-household correlation. multivariate models were derived from this method to identify factors associated with elevated gmts. we defined the ''gmt ratio'' (gmtr) as the multiplicative factor applied to the gmt in presence of an explanatory variable. for qualitative explanatory variables, a gmtr of n means a predicted n-fold higher gmt for subjects exposed to the considered factor compared to others. for continuous explanatory variable, the same interpretation applies to a unit difference. the following variables were included in the multivariate models: age, history of pandemic or seasonal influenza vaccination, and history of ili. age was categorized in three groups: - years (reference group), - years and over years. the definition of ili was that used by the cdc : fever ‡ ae °c and cough and ⁄ or sore throat without another known cause. history of ili was defined as an ili reported by the subject between september , (beginning of the influenza epidemic in france) and the date of inclusion. this preliminary analysis included subjects belonging to households. results reported hereafter do not account for missing data. participating households were sized - subjects, mean size = ae . in comparison, the mean size of french households is ae according to the latest national census. the median age of subjects at entry was ae years [iqr: ae ; ae ] versus ae [ ae ; ae ] for french population. the proportion of subjects reporting a history of ili since the beginning of the epidemic varied from ae % for subjects over years to ae % for subjects below years (table ) . vaccination with the pandemic strain was the highest in subjects below ( %) whereas vaccination with the seasonal strain was the highest in subjects over ( ae %). detailed data regarding vaccination is given in table . this study confirms previous findings that age, pandemic influenza vaccination, and history of ili are associated with elevated post-seasonal gmt. [ ] [ ] [ ] [ ] [ ] [ ] among non-vaccinated subjects, elevated gmt in the elderly may be the result of exposure to similar viruses in early life, whereas children and young adults with elevated gmt are likely to have been infected by the a ⁄ h n v virus. [ ] [ ] [ ] [ ] interestingly, a significant drop in the hai titer is observed during the months following vaccination with the pandemic strain. this study also shows that seasonal influenza vaccination may have contributed to an increase of the hai titer, especially in the elderly. the reason for this association is not obvious: although we cannot discard the hypothesis of a higher incidence of a ⁄ h n v infections in seasonal vaccine recipients, as described by several other studies, - the main explanation may be a cross-reaction between pandemic and seasonal strains. , , further analyses in this cohort are needed to confirm and explain these first results. the follow-up of subjects involved in the copanflu-france cohort will provide data to study the risk factors for infection by the influenza virus. in april , the cdc alerted about the appearance of a new strain of ia h n with unknown virulence. infants under years old had higher risks of hospitalization, complications, and rate of death for sari. materials and methods: a cross-sectional study was executed from may to december in . the sources were: mandatory reporting form of the province surveillance system, databases of the hospital management information system, clinical pictures reviews, and telephone daily medical reports. inclusion criteria: children under years old with diagnostic of ili or sari and confirmed cases with epidemiological nexus or laboratory confirmation (rrt-pcr, ifi). the age specific mortality rates were calculated with an estimated population for the province according to the national statistics and census institution. results: the ili rate in infants under years old was ae ⁄ people ( % ci - ) being higher in infants of years old ( ⁄ people of years ( % ci - ) ( table ) . infants had less risk of getting sick in relation to the rest of the population (rr ae [ % ci ae - ae ]) (p < ae ). the chance of sari in infants was ae ( % ci ae - ae ) compared to the rest of the population. the lethality rate was higher in infants under year old ( ⁄ people [ ⁄ ]). discussion: the evidence suggests that the infants under years old had lower risk of getting sick than the rest of the population, but had higher risk of sari if they had some past illness. the highest lethality rate was presented in infants under year old. non-medical interventions had an important role in the epidemic containment for not having a specific vaccination available. as this age group had high risks of hospitalization, it would be advisable to prioritize their vaccination. in april , the cdc alerted about the appearance of a new strain of ia h n with unknown dissemination and virulence. in june, the world health organization declared the pandemic. , the ili often presents an unspecific clinical picture in infants under years old, from mild symptoms to sari, especially in the newborn babies. infants under years old have higher risks of hospitalization, complications, and rate of death for sari. , on may th, argentina declared the first imported case of ia h n , and by the end of the month, it announced the viral circulation in the country. the epidemiological surveillance system of the province arranged that all the patients with influenza diagnosis made by a doctor must be reported. from april th to november th, suspected cases of ili in the province of tucumán were reported. the ili rate was ⁄ people, and ia h n comprised ⁄ people. the lethal rate of sari ia h n was ae ⁄ people ( ⁄ ). the objective of this research was to determine the epidemiological characteristics of the pandemic ia h n in infants under years old in the province of tucumán between may and december in . the province of tucumán is placed in the center of the northwest of the republic of argentina. it has a population of inhabitants of which are infants under years old. the crude birth rate for was ae &. the infant mortality rate was ae &. respiratory pathologies in infants under years old were the third cause of death in the province ( %). the public health system of the province is composed by three sectors: public, private, and welfare. with health facilities as a total, the average of available beds is & per inhabitants and & per neonates. a cross-sectional study was executed from may to december in in the province of tucumán, argentina. the following sources were used: mandatory reporting form of the surveillance system of the province filled by a doctor, databases of the hospital management information system, clinical pictures reviews, and telephone daily medical reports (patients with sari). inclusion criteria: • suspected case of ili: sudden appearance of fever higher than °c, cough, or sore throat. it may or may not be accompanied by asthenia, myalgia or prostration, nausea or vomiting, rhinorrhea, conjunctivitis, adenopathy, or diarrhea. ) were used for the analysis. the odds rations, risk ratio and % confidence interval were calculated to compare ambulatory with hospitalized patients, confirmed and dismissed, < years old and the rest of the population. it was considered significant a rate of p < ae . the age specific mortality rates were calculated with an estimated population for the province according to the national statistics and census institution. the epidemiological surveillance system of the province received ili reports, ae % ( ⁄ ) were infants under years old. twenty seven percent were dismissed ( ⁄ ), and % ( ⁄ ) of suspected cases were confirmed. the first ia h n case was a child of years from the province of buenos aires, in th epidemiological week, and the last suspected case was reported in october , ( figure ). the ili rate in infants under years old was ae ⁄ people ( % ci - ), being higher in infants of years old ( ⁄ people of years, [ %ci - ]). the higher ili rates in confirmed the pandemic of ia h n ( ) was detected for the first time in the province of tucumán. the evidence suggests that infants under years old had lower risk of getting sick than the rest of the population (protective factor), but had higher risk of sari if they had some past illness. the highest lethality rate was presented in infants under year old. towns with the highest demographic density had superior proportion of cases. non-medical interventions had an important role in the epidemic containment for not having a specific vaccination available. as this age group had high risks of hospitalization, it would be advisable to prioritize their vaccination. outbreak of h n influenza - : behavior of influenza h n in school children in the province of tucumá n, argentina criteria: patients treated with antiviral medication for prophylaxis, respiratory pathologies which did not justify specific medication, and incomplete forms. results: from all notifications, were cases of ili in the group aged - years old; % were males. the incidence rate in this group was ae per thousands of inhabitants. the % of laboratory samples were influenza a h n , % were confirmed as unspecific influenza, and % were dismissed. the school aged children group had a high risks of getting sick (r.r. ae [ % c.i. ae - ae ]), especially males. it appeared that school aged children had a protective factor for presenting sari (or ae [ % c.i. ae - ae ], p < ae ). the lethality rate in this group was ae ⁄ thousands. headaches, myalgia, coryza, and sore throat were very common and significantly different (p < ae ) than the rest of the population. it was reported a decrease in the ew coinciding with winter holidays (ew ). the epidemic curve was different in males compared to females during the winter holidays. discussion: school aged children got sick more than the rest of the population, although they presented less proportions of sari. however, comorbidities were decisive in order to present sari or death. the epidemic curve was different in males compared to females. through its analysis, the beneficial effect of school closure was observed, as long as children meet the recommendation to stay home. in april , different countries reported cases of influenza a h n ; mexico reported a high mortality rate associates with this disease. the world health organization (who) declared the phase influenza pandemic alert on june . several reports from different countries describe the behavior of the pandemic in school aged children. this group plays an important role in the transmission of influenza. in germany, during the summer peak, pandemic hardly spread within this group. this might be explained by the timing of the summer school holidays, which started between ew and . since mid october, after the autumn holidays, the school-aged children began to be more affected, and the proportion increased from % in the initiation period to ae % in the acceleration period. in australia, % of h n cases were school aged children ( - years), with a median age of years ( % of cases were aged - years and, and % between - years). in canada, the infection rate was highest in this group. in chile, the incidence rate was ⁄ inhabitants, although in general they had mild desease. school closure can operate as a proactive measure, aimed at reducing transmission in the school and spread into the wider community, or reactive, when the high levels of absenteeism among students and staff make it impractical to continue classes. the main health benefit of proactive school closure comes from slowing down the spread of an outbreak within a given area and, thus, flattening the peak of infections. this benefit becomes especially important when the number of people requiring medical care threatens to saturate health care capacity. it has its greatest benefits when schools are closed very early in an outbreak, before % of the population falls ill. school closure can reduce the demand for health care by an estimated - % at the peak of the pandemic under ideal conditions, but too late in the course of a community-wide outbreak, the resulting reduction in transmission is likely to be very limited. policies for school closure need to include measures that limit contact among students when they are not in school. tucumán is placed in northwest argentina and has a total area of km . the population ( census, projection ) was inhabitants; of wich were - years old. the health system of the province is composed of sectors: public, private, and welfare. it has a total of health facilities with internement available and an average of & inhabitants. influenza-like illness (ili) has seasonal and endemic behavior in this province, as evidenced by past records from the national health surveillance system and influenza sentinel surveillance unit of the province. an increase of ili was reported in , with a peak in the ew . the objectives were: general objective to describe the behavior of the influenza a h n epidemic in school aged children from the province of tucumán, argentina. specific objectives • to explore the response to preventive measures by school aged population. • to assess the effect of the suspension of classes in this group. • to estimate the magnitude and severity of the disease. • to observe the effect of co-morbidities in this group. a cross-sectional study was executed from may to december . data were gathered through mandatory reporting forms, wich were collected from all public and private health centers. inclusion criteria: patients with compatible symptoms with influenza a; school aged children - years old. exclusion criteria: patients treated with antiv- iral medication as prophylaxis, respiratory pathologies which did not justify specific antiviral medication, and incomplete forms. • suspected case of ili: cases considered by clinical criteria (fever higher than °c, cough or sore throat. it may or may not be accompanied by asthenia, myalgia or prostration, nauseas or vomiting, rhinorrhea, conjunctivitis, adenopathy, or diarrhea). • confirmed case: person with positive laboratory results for influenza a h n or unspecificed influenza a (by laboratory results through rrt-pcr or immunofluorescence techniques). • dismissed case: by negative or different laboratory results, or different clinical evolution. • comorbidities: chronic illnesses like arterial hypertension, diabetes, asthma, recurrent obstructive bronchial syndrome (robs), smoking, chronic obstructive pulmonary disease (copd), immunosuppression, hiv ⁄ aids, cancer, nephropathy, obesity; pregnancy was also considered. data were analyzed using epi software (epi infoÔ cdc, atlanta, eeuu). rates were calculated and rr was estimated with their respective confidence interval (ci). population data were taken from national census projections. an estimation based on the same census was used for the group between and years old. to observe the effects of other co-variables, the or and their ci were calculated. logistic regression was used to evaluate the influence of the comorbidities. x was used to compare proportions. respiratory samples (nasopharyngeal and faryngeal swabs) were obtained. they were analyzed at influenza sentinel surveillance unit of tucumán, and ⁄ or sent to national reference laboratory dr. c. malbrán (rt-pcr). from all notifications ( ), were cases of ili in the group aged between and years old, % ( ⁄ ) of which were males. the incidence rate was ae , and it differed according to the sexes: ae males and ae females per thousands of inhabitants (p < ae ). of all laboratory samples ( ) % were confirmed as influenza h n , % were confirmed as unspecificied influenza, and % were dismissed. the remaining percentage corresponded to the isolation of other viruses (parainfluenza, respiratory syncytial virus, and adenovirus). the school aged group had higher risk of getting sick, in relation to the rest of the population (rr ae [ % ci ae - ae ]), especially males (rr ae ) compared with females (rr ae ). the highest attack rate was observed in the capital of tucumán ( ⁄ inhabitants). according to the rest of the population, it looked like being school aged children meant a protective factor for presenting sari (severe acute respiratory infection) (or ae [ % ci ae - ae ], p < ae ). the lethality rate was ae ⁄ thousand. the risk of dying was low compared to other ages. persons with comorbidities had significantly higher risk of presenting sari (or ae [ % ci ae - ae ], p < ae ) and of dying (or ae [ % ci ae - ae ], p < ae ). respiratory comorbidities were the most fre- quent: asthma ae % ( ⁄ ) and % rors ( ⁄ ). the symptoms headaches, myalgia, coryza, and sore throat were very common and significantly different (p < ae ) than the rest of the population. if we compared the group aged - years with - years old, the epidemic curve of the first group showed a decrease in the ew , coinciding with winter holidays (ew ) (figure ). there was a slight increase in the tendency when classes began, but it showed a clear declination afterwards. the analysis of rates in school aged children by ew showed a reduction of ae % in males and ae % in females (p < ae ) at ew . however, after the first week of winter holidays, the curve in males had a significant increased to ae % compared to ew , reaching the highest weekly rate of the epidemic ( ⁄ inhabitants). the reopening of classes coincided with a significant decrease of the rate ( ae %), from to ae ⁄ inhabitants in ew (p < ae ). in females, the school closure coincided with a plateau-shaped curve, and the reopening with a significant decrease of ae % of the rate, from ae to ae in ew ( figure ). the school children got sick a lot more than the rest of the population, although they presented less proportions of sari. however, comorbidities were determined in order to present sari or death. symptoms like headache, myalgia, coryza, and sore throat were considered more conducting for the definition of cases in this population in tucumán. the epidemic curve was different in males compared to females during the winter holidays. the beneficial effect of school closure was observed as long as persons met the recommendations. the difference between males compared to females during winter holidays could mean that women would have carried out social distance recommendations much better, for example, remained at home. the significant reduction after the opening of classes is a factor to be considered as an effective intervention in the declining stage of the curve. here, we report pdmh n infection attack rate (iar) during the first wave of the pandemic. we used our iar estimates to infer the severity of the pandemic strain, including the age-specific proportion of infections that led to laboratory confirmation, hospitalization, intensive care unit (icu) admission, and death. [ ] [ ] [ ] [ ] part of these results are now available in ref. subjects of a community study, - years old between november and october , we conducted a cohort study of pediatric seasonal influenza vaccination and household transmission of influenza. one hundred fifty-one children aged - were recruited and provided baseline sera in november and december . between september and december a further children aged - were recruited and provided baseline sera for the second phase of the study. for this serologic survey, we tested the sera collected before the first wave and the sera collected after the first pandemic wave. written informed consent was obtained from all participants. parental consent was obtained for participants aged or younger, and children between the ages of and gave written assent. all study protocols were approved by the institutional review board of the university of hong kong ⁄ hospital authority hong kong west cluster. age-stratified data on virologically confirmed outpatient consultations, hospitalizations, icu admissions, and deaths associated with pdmh n from april to november were provided by the hong kong hospital authority (the e-flu database). since may , patients admitted with acute respiratory illnesses routinely underwent laboratory testing for pdmh n virus by molecular methods. sera were tested for antibody responses to a ⁄ california ⁄ ⁄ by viral microneutralization (mn). most individuals infected with influenza develop antibody titers ‡ : by viral microneutralization after recovery. we defined the pdmh n seroprevalence rate as the proportion of individuals who had antibody titers ‡ : . while mn antibody titers of ‡ are not by themselves conclusive evidence for pdmh n infection, we have assumed that the increase in cross-sectional seroprevalence between the pre-and post-first wave time periods are evidence of recent pdmhn infection. the iar was defined as the proportion of individuals infected by pdmh n during the first wave. the case-confirmation rate (ccr), case-hospitalization rate (chr), case-icu-admission rate (cir), and case-fatality rate (cfr) were defined as the proportion of pdmh n infections that led to laboratory-confirmation, hospitalization, icu admission, and death. due to containment efforts until june , all laboratory-confirmed cases were required to be hospitalized for isolation regardless of disease severity. as such, only surveillance data from june onwards were used to estimate severity measures. we estimated the iar as the difference between the prefirst-wave and post-first-wave seroprevalence rate. we used the estimated iar as the denominator for calculating the ccr, chr, cir, and cfr. we used an age-structured sir model with age classes ( - , - , - , - , and ‡ ) to describe the transmission dynamics of pdmh n in hong kong between june and november . we assumed that the mean generation time was ae days. using the age-structured transmission model, we estimated the following transmission parameters from the serial cross-sectional serologic and hospitalization data: (i) r o , the basic reproductive number; (ii) p and p , the reduction in within-age-group transmission for - and - years old during summer vacation (compared to school days during september-december ); (iii) d r , the average time for neutralization antibodies titer to reach ‡ : after recovering from infection; (iv) h a , the age-specific relative susceptibility with - years old adults as the reference group. we assumed non-informative priors for all parameters and used monte carlo markov chain methods to obtain posterior distributions of the parameters. sources of specimens: [ ] pediatric cohort study ( - april virological surveillance data suggested that the first wave of pdmh n in hong kong occurred from august to october . most of the laboratory-confirmed infections in this first wave occurred in individuals aged below years old accounting for > % of the lab-confirmed cases and hospitalizations, % of icu admissions, and % of deaths. taking into account a delay of - weeks for antibody titers to appear during convalescence, we found that these virological surveillance data were consistent with our serial cross-sectional seroprevalence data, which indicated a sharp rise in seroprevalence among the - years old from september to november and a plateau thereafter (data not shown). among individuals aged - years, the seroprevalence rates were similar across time between pediatric outpatient subjects and pediatric cohort study subjects (data not shown). similarly, for older age groups, the seroprevalence rates were largely similar between blood donor subjects and hospital outpatient subjects (except for the - years old in november-december). this provided some evidence that despite biases in our convenience sampling scheme, the resulting serologic data provided a reasonably representative description of seroprevalence in the community. the estimated pre-and post-first-wave seroprevalence rates and the corresponding iar estimates are shown in table . the severity estimates (ccr, chr, cir, and cfr) are shown in table . in summary, we estimated the iar was ae % among - years old, ae % among - years old, ae % among - years old, ae % among - years old, ae % among - years old, and ae % among - years old. overall, we estimated a population-weighted iar of ae % ( - %) among individuals aged - years through the first wave in hong kong. ccr were around ae - ae % among the - years old. chr were around ae - ae % among the - years old. cir increased from ae ( ae - ae ) per infections in - years old to ( ae - ) per infections in - years old. cfr followed a similar trend with ae ( ae - ae ) death per infections in - years old to ae ( ae - ) deaths per infections in - years old. compared to children aged - , adults aged - were ae and times more likely to be admitted to icu and die if infected. the best-fit age-structured transmission model gave the following parameter estimates: . the basic reproductive number was ae ( %ci, ae - ae ). . it took an average of ( - ) days for recovered individuals to develop neutralization antibody titer ‡ : . table . estimated age-specific proportions of individuals with pdmh n infections that were laboratory-confirmed, were hospitalized, were admitted to icu, and died. case-icu and case-fatality rates are expressed as number of episodes per infections . compared to - years old, - years old children and - teenagers were ae ( ae - ae ) and ae ( ae - ) times more susceptible to pdmh n infection, respectively. . compared to - years old, - years old older adults and - years old elderly were only ae ( ae - ae ) and ae ( ae - ae ) times as susceptible as the - years old, respectively. . compared to the school period during september-december , summer vacation reduced within-agegroup transmission by % ( - %) among - years old, but only % ( - %) among - years old. using computer simulations, we estimated that if preexisting seroprevalence is zero, real-time serologic monitoring with about specimens per week would allow accurate estimates of iar and severity as soon as the true iar has reached % (data not shown). we estimated that during the first wave in hong kong, ae % of school-age children and ae % of individuals aged - were infected by pdmh n . a serologic survey in england found similar iars in london and the west midlands. both studies highlight the importance of including serologic surveys in pandemic surveillance. the geographically compact and well-mixed population in the urban environment of hong kong permits some degree of confidence in the validity of our iar and severity estimates. the completeness of the pdmh n surveillance system, welldefined population denominator, and our large-scale serologic survey provide accurate numerators and denominators for the severity measures. we based severity estimates for pdmh n on the iar as the denominator. in most previous studies of pdmh n severity, the denominator was clinical illness attack rate, which depends on the probability of symptoms as well as medical care seeking behavior of the population. , our estimated cirs and cfrs are broadly consistent with presanis et al.'s 'approach ' severity estimates, but around - times lower than their 'approach ' estimates. our estimates of chr are - times higher than their approach estimates of symptomatic chr. however, the hospitalization-death ratio was ⁄ = as of november in hong kong, but ⁄ = as of june in new york, suggesting that the clinical threshold for admission in terms of disease severity at presentation may have been lower in hong kong. our study has a number of limitations. first, we have used antibody titers of ‡ : by viral microneutralization as an indicator of recent infection, correcting for pre-existing seroprevalence levels, but this may lead to underestima-tion of the iar if some infections led to antibody titers < : , or if some individuals with baseline titers ‡ : were infected. second, our estimates of the iar would be biased upwards if infection with other circulating influenza viruses led to cross-reactive antibody responses resulting in antibody titers ‡ : . however between august and october , % of influenza a viruses detected in hong kong were pdmh n , and only % of isolated viruses were seasonal h n viruses. third, a minority of severe illnesses associated with pdmh n infection might not be identified by molecular detection methods, for example if admission occurred after viral shedding from the primary infection has ceased, in which case we may have underestimated the disease burden of pdmh n . finally, our analyses are primarily based on seroprevalence among blood donors to the hong kong red cross, who may not be representative of the whole population. we do not have detailed data on donors to compare their risk of infection with the general population, but we did observe very similar seroprevalence rates across the three groups of subjects in our study, i.e., blood donors, hospital outpatients and participants in a community cohort (data not shown). in conclusion, around ae % of the population aged - and half of all school-age children in hong kong were infected during the first wave of pandemic h n . compared to school-children aged - , older adults aged - , though less likely to acquire infection, had ae and times higher risk of icu-admission and death if infected. thus, although the iar of pdmh n is similar to that of a seasonal epidemic, the apparently low morbidity and mortality of pandemic influenza (h n ) appears to be due to low infection rates in older adults who had a much greater risk of severe illness if infected. the reasons why older adults appear relatively resistant to pdmh n infection even though they appear to lack neutralizing antibody remains unclear. if antigenic drift or other adaptation of the pdmh n virus allows these older age groups to be infected more efficiently, the morbidity and mortality of subsequent waves of the pandemic could yet become substantial. and the national institute of allergy and infectious diseases, national institutes of health (contract no. hhsn c; adb no. n -ai- ). the funding bodies had no role in study design, data collection and analysis, preparation of the manuscript, or the decision to publish. bjc reports receiving research funding from medimmune inc., a manufacturer of influenza vaccines. the authors report no other conflicts of interest. some data presented in this manuscript were previously published in wu et al. it is well known that a primary goal of vaccination is to generate immunological memory against the targeted antigen to prevent disease in a vaccinated person. this ensures an accelerated immune response in the event of future contact with the pathogenic agent, such as a virus. therefore, it is very important to develop criteria for the assessment of vaccine immunogenicity by measuring both t and b memory cell levels from the vaccinated host. in contrast to inactivated influenza vaccines, live attenuated influenza vaccines (laivs) have been shown to provide primarily cellular and local immune responses. - to date, however, the hemagglutination-inhibition (hai) test (i.e. detection of serum antibodies) remains the method widely accepted for evaluation of an influenza vaccine's immunogenicity. improved understanding of the role of cellular and mucosal immunity and their contribution to protecting against severe illness caused by influenza infection has emphasized the need to reconsider methodologies used to evaluate the immunogenic impact of various influenza vaccines. such new assays need to include methods to measure local antibodies and virus-specific lymphocytes, especially in the case of live attenuated influenza vaccines, because of their potential to induce such broad-based immune responses. the aim of this study was to assess the ability of new russian pandemic laivs a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) ('ultragrivak,' registered ae ae ) and a ⁄ ⁄ california ⁄ ⁄ (h n ) ('influvir,' registered ae ae ) to induce memory t-cells in naïve human subjects and to compare results to levels of hai antibodies from each subject. a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) laiv was generated by : genetic reassortment of low-pathogenic avian influenza virus a ⁄ duck ⁄ potsdam ⁄ - (h n ) and master donor strain a ⁄ leningrad ⁄ ⁄ ⁄ (h n ). , the vaccine strain contains ha gene from avian virus, as well as na and internal genes from the master donor virus. a ⁄ ⁄ california ⁄ ⁄ (h n ) laiv was generated by classical ( : ) reassortment of a ⁄ california ⁄ ⁄ (h n ) with the master donor virus. the vaccine strain contains ha and na genes from a 'wild-type' h n strain and internal genes from the master donor virus. participants were aged to years and were without contra-indication of laiv vaccination. immunogenicity of a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) laiv was assessed in ten vaccinated persons and ten volunteers inoculated with a placebo (sterile physiological saline solution). immunogenicity of a ⁄ ⁄ california ⁄ ⁄ (h n ) laiv was estimated in vaccinated volunteers and nine volunteers inoculated with placebo. viruses or placebo were administered intranasally twice with an interval period of days at a dosage of ae ml per nostril for each vaccination. physical examination, venous blood and nasal swab samples were collected at four time points during the study: (i) before vaccination (day ); (ii) days after first vaccination (day ); (iii) days after the second vaccination (day ); and (iv) weeks after the second vaccination (day ). serum hai antibodies were measured by standard hai assay using % human red blood cells. test antigens for the assay were a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) or a ⁄ ⁄ california ⁄ ⁄ (h n ) to match the appropriate vaccine antigen. local iga antibodies in nasal swabs were evaluated by elisa using whole purified a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) or a ⁄ ⁄ california ⁄ ⁄ (h n ) viruses at hau per ae ml for absorption to elisa plates. endpoint elisa titers were expressed as the highest dilution of sera that gave an optical density (od) greater than twice the mean od of six negative controls in the same assay. percentages of virus-specific cd + cd + ifn-c + and cd + cd + ifn-c + peripheral blood memory cells were determined using a flow cytometry iccs assay performed by the published method. pbmcs were prepared with standard histopaque- gradient centrifugation from heparinized whole blood. wilcoxon matched pair test, mann-whitney u test and the students t-test were used for statistical data analysis. prior to the first vaccination (day ), gmts of hai antibodies to a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) and a ⁄ ⁄ california ⁄ ⁄ (h n ) laivs were ⁄ ae and ⁄ ae , respectively. in addition, gmts of siga against these specific antigens from nasal swabs were ⁄ ae and ⁄ ae , respectively. no hai antibody titers greater than : were observed prior to vaccination. background levels of virusspecific t-cells varied significantly within groups. mean levels of virus-specific cd + ifnc + cells were ae % to a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) and ae % to a ⁄ ⁄ california ⁄ ⁄ (h n ). for cd + ifnc + cells, initial levels were ae % and ae %, respectively. thus, background levels of virus-specific antibodies were low, but prior vaccination or virus exposure in some volunteers produced some pre-existing levels of t cells, thus they were not absolutely immunologically naïve in this sense. preexistence of h n -crossreactive antibodies and t-cells has been observed previously. [ ] [ ] [ ] effect of vaccination antibody immune responses both influenza a (h n ) and influenza a (h n ) laivs stimulated production of serum hai antibodies and local iga antibodies in nasal swabs. following the first vaccination with influenza a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ (h n ) laiv, % percent of volunteers exhibited seroconversion of hai antibodies; after the second vaccination, % of volunteers exhibited seroconversion. after the first vaccination, a % conversion rate of siga was observed; after the second vaccination, % showed conversions in levels of siga. the first vaccination with a ⁄ ⁄ california ⁄ ⁄ (h n ) laiv showed ae % of hai antibodies seroconversions vaccination, and % seroconversion after second vaccination. for local siga, those results were ae % and ae % following the first and second inoculation, respectively. figure summarizes cellular immune responses observed in the vaccinated versus the placebo group. after the influenza a (h n ) laiv inoculation, significant differences in both cd and cd ifnc-producing t-cells were observed at day after the second vaccination (d ). these data indicate that healthy young people who never received such avian influenza vaccines and were not exposed to h n wild-type viruses were able to respond to the live attenuated h n influenza vaccine. after the first influenza a (h n ) laiv vaccination, reliable increases were observed in cd + cells only. after the second vaccination, increases in both cd + and cd + fold changes were significantly higher in vaccinated volunteers compared to the placebo group. it is noteworthy that cellular immune responses (cd + and cd + cells) were more marked in the a ⁄ ⁄ california ⁄ ⁄ (h n ). considering the long-term circulation of h -subtype viruses among humans in contrast to the novelty of h viruses, such a result would be expected. similar data were also observed following vaccination with the h n laiv. after first vaccination, the percent of people with notable increases in virus-specific cd + and cd + t-cells was % and % to h n and % and % to h n , respectively. after the second vaccination, these results were % and % to h n and % and % to h n , respectively. importantly, a significant number of vaccinated volunteers without remarkable increases ( ‡ -fold) in hai antibodies had notable increases in cd + and ⁄ or cd + memory cells. the percent of people with notable increases in virus-specific t cells after the second vaccination among hai()) volunteers was % and % to h n and h n , respectively. these results indicate that laivs were able to induce broadly responsive, key antiviral immune responses that would not have been detected by the hai assay alone. thus, it can be deduced that hai data alone fails to reveal important broad and specific immune responses to laiv. consequently, the hai test alone is not suitable for assessment of laiv immunogenicity. furthermore, vaccination with h n laiv was able to induce cross-reactive memory t-cells to a seasonal vaccine strain, a ⁄ ⁄ solomon islands ⁄ ⁄ (h n ) ( table ) . reliable increases to a (h n ) were observed in up to % of volunteers. there was an inverse dependence between levels of memory t cells before and after vaccination. authors are thankful to path for the financial support of these studies. we are also thankful to jessica d'amico and dr. rick bright for their editorial review. options for the control of influenza vii background: increased susceptibility of older populations to secondary bacterial pneumonia-like infections following influenza infection has been well documented. recent evidence in mouse models suggests that this increased risk from secondary bacterial infection occurs through a desensitization of the innate immune response. this recent finding, however, does not account for potential differences in immune responsiveness due to age. materials and methods: to address this parameter, we used three age groups (aged, adult, and young mice) to evaluate the role of age in influenza-mediated vulnerability to secondary bacterial challenge with pseudomonas aeruginosa. all mice were evaluated for multiple parameters including: (i) survival; (ii) lung bacterial load; (iii) total lung protein content; (iv) immune cell infiltration; (v) cytokine ⁄ chemokine expression; and (vi) toll-like receptor (tlr) rna expression profiles. results: prior challenge with influenza contributed to aberrant cytokine ⁄ chemokine profiles and increased lung cellular infiltrate in response to secondary bacterial infection across all age groups, supporting a critical role for influenza infection in the alteration of immune responses to other pathogens. also similar to human influenza, these changes were exacerbated by age in mice as demonstrated by increased bacterial load, mortality, and total lung protein content (an indicator of lung damage) after p. aeruginosa challenge. conclusions: these data support a potential role for virus-mediated and age-mediated alteration of innate immune effectors in the pathogenesis of influenza and the increased susceptibility of influenza virus infected mice to secondary bacterial infection. the understanding of the complex interaction of host and pathogen -and the role of age -in human influenza is critical in the development of novel therapeutics and improved vaccine approaches for influenza. our results support further examination of influenza-mediated alterations in innate immune responses in aged and non-aged animals to allow elucidation of the molecular mechanisms of influenza pathogenesis in humans. there is considerable evidence in the clinical literature to support the role of influenza infections with an enhanced risk for secondary bacterial pneumonias. [ ] [ ] [ ] given the increased pneumonia-related morbidity and mortality in both the young and elderly populations, there is rationale for gaining a deeper understanding as to the systemic changes in the pulmonary microenvironment. although there are some recent reports that account for some of the molecular mechanisms at work in this disease process, there is a paucity of experimental evidence that considers the potential effects of age. developmental changes in the immune system that occur in the aged environment have been well documented with regard to senescence of the adaptive immunity, global changes in myeloid cell function, and the establishment of a general pro-inflammatory state. , the aim of this work was to provide evidence for the contribution of the aged immune environment to the pathology of influenza mediated secondary bacterial infections. animals used in this study were housed under conditions approved by tulane university's institutional animal use and care committee. female balb ⁄ c mice used in these studies were divided into three age groups: aged ( months old), adult ( months old), and young ( months old). each age group was subdivided into two groups: influenza infected and naïve (control). mice were infected by the intranasal route with · pfu of mouse-adapted influenza a ⁄ pr ⁄ ⁄ . clinical disease was measured by body weight changes over a week period post influenza challenge, and recovery was determined as return to pre-infection weight. all mice were subsequently challenged intransally with · cfu pseudomonas aeruginosa strain pao . twenty-four hours post-pseudomonas challenge, bal with sterile pbs was performed on all mice in all groups. total rna from the cellular fraction was pooled from three experimental animals from each group. tlr mrna was detected by qrt-pcr, where expression levels were determined as relative to b-actin mrna levels. cdna was synthesized from total cellular rna from bal samples using iscript cdna synthesis kit (biorad). pcr reactions were composed of ae lg cdna forward and reverse primers according to optimized conditions and ae ll of · syber green icycler supermix (biorad), in a total vol-ume of ll and were run using a biorad icycler utilizing melting point determination. primers and concentrations used in this study included: mus_tlr f: tgctttcct-gctggagattt- nm, mus_tlr r: tgtaacgcaac agcttcagg- nm, mus_tlr f: atatgcgcttcaa tccgttc- nm, mus_tlr r: caggagcatactggt gctga- nm, mus_tlr f: ggcagcaggtggaattg tat- nm, mus_tlr r: aggccccagagttttgttc t- nm, mus_tlr f: ctggggacccagtatgctaa- nm, mus_tlr r: acagccgaagttccaagaga- nm, mus_tlr f: ggagctctgtccttgagtgg- nm, mus_tlr r: caaggcatgtcctaggtggt- nm, mus_ b-actinf: agccatgtacgtagccatcc- nm, mus_b-actinr: ctctcagctgtggtggtgaa- nm. as a measure of protein leakage into the alveolar space, total protein content in each bal was measured by bca assay of each supernatant fraction according to manufacturer's instructions (pierce). cytokine and chemokines levels were measured by multiplexed bead array (bioplex, biorad). immune cell characterization of bal was estimated by flow cytometry. lymphocyte populations were gated by forward versus side scatter and characterized as b cells (f ⁄ ) , cd + ) or t cells (cd b ) , cd + ). the myeloid population that is composed of macrophages, neutrophils, dendritic cells, and natural killer cells was enumerated by gating all but those found in the lymphocyte gate using forward versus side scatter plots. flow cytometry data was analyzed using flojo software (treestar). statistical analysis, where appropriate, was performed using a two-way analysis of variance (age versus influenza infection status) supported by bonferonni's correction for multiple comparisons. a recent finding by didierlaurent, et al., described an influenza mediated desensitization of tlr function as a primary contributor to an increase in bacterial burden when challenged after resolution of the primary influenza infection. this finding, however, was obtained using animals that were - weeks of age, where our study included two cohorts of older mice ( months and months). using whole protein content of the bal as an estimate of protein leakage into the lumen of the lung, we found elevated protein content in aged mice as compared to young and adult mice. in aged mice, a slightly lower total lung protein when comparing influenza infected to protein in the bal from influenza naïve mice challenged with p. aeruginosa (table ) . supporting previously published studies showing a generalized pro-inflammatory cytokine environment in the aged immune system, we provide evidence for significantly (p = ae ) and an increase in ifnc (p = ae ) was detected. the decrease in gm-csf correlates well with a previous report that gm-csf is less prevalent in influenza resolved animals (table ). we also report a noticeable change in the immune cell populations with respect to b-cells, cd + t-cells, and the myeloid cell populations. there is a trend of increased prevalence in cd t-cells in the post-influenza environment across all ages. b-cell numbers also trend toward increase in influenza treated animals in young and adult animals; however, there is a noticeable decrease in the bcells in aged animals. across all age groups, there is a general decrease in frequency of cells that would normally make up the myeloid cellular fraction of the bal (macrophages, neutrophils, dendritic cells, and natural killer cells) ( table ). our study also shows, as cited by others, that toll-like receptor (tlr) gene expression in the post-influenza environment is decreased in cells found in the bal after both influenza and pseudomonas infection. our data support the previous finding of a reduced expression of tlr mrna in influenza-cleared mice when we measured tlr , , , and . only tlr showed differences with respect to age with young mice showing little or no detectable change in tlr mrna expression. our results show an increase in the expression across all tlrs examined in the aged mice group (table ) irrespective of influenza infection status. these data support earlier studies performed with adult mice that showed reduced tlr mrna expression in the post-influenza environment. this study also expands the current understanding of the potential role of age in influenza mediated bacterial infection-induced mortality. the impact of these alterations in the immune microenvironment across age groups and infection status is highlighted by the ability of bacterially challenged animals to clear infection. assessment of bacterial load in the lungs of p. aeruginosa challenged mice indicated a difference in young and adult mice if previously infected with influenza virus. in aged mice, both influenza challenged and influenza-naïve mice had higher bacterial loads and less variability when comparing within the age group, supporting the risk of age alone in susceptibility to bacterial pneumonia (table , figure ). taken together, these data support the potential role for both virus-mediated and age-mediated alteration of innate immune effectors in the pathogenesis of influenza and increased the susceptibility to secondary bacterial infection that results from influenza infection in mice. these findings highlight distinct differences in the immune environment between age groups and thus reveal necessity for further examination as to the mechanisms of immunity across age with respect to current infection status. garnering a clearer understanding as to the complex interaction of host and pathogen with respect to age in influenza infections is central to the development of increased efficacy in vaccine and therapeutic strategies. prospective estimation of the effective reproduction background pandemic influenza a (h n ) virus (ph n ) emerged in early and rapidly spread to every continent. an urgent priority for international and national public health authorities was to estimate the transmissibility of the pandemic strain for situational awareness and to permit calibration of mitigation strategies. the basic reproductive number, r , is defined as the average number of secondary cases that index case generates in a completely susceptible population, and is a common measure of transmissibility. however, it is difficult to estimate r without an understanding of the degree of any pre-existing immunity in the population. the effective reproductive number, r, is defined as the average number of secondary cases that index case generates, and can be estimated over time (i.e. r t ). wallinga and teunis described a method to estimate r t based on illness onset dates of the cases while assuming that all secondary cases would have been detected, and cauchemez et al. extended the method to permit prospective estimation by adjusting for secondary cases that have not yet experienced illness onset at the time of analysis. we describe how the method can further be extended to account for reporting delays, allowing true real-time estimation of r t during an epidemic, and we illustrate the methodology on notifications of ph n and associated hospitalizations in hong kong. we obtained data on all laboratory-confirmed ph n infections ('cases') reported between may and november , to the hospital authority and center for health protection in hong kong collated in the eflu database. a subset of the cases was hospitalised. the database also included information on age, sex, illness onset date, laboratory confirmation date, and contact history (for the early cases). laboratory-confirmed ph n infection was a notifiable condition throughout our study period. we extended existing methods for estimating r t over time to allow for reporting delays between illness onset and notification, and between illness onset, notification, and hospitalisation for those cases that were hospitalised, where the reporting delay distribution were estimated empirically from the data. we further extended the methodology to allow for imported cases (infected outside hong kong) contributing to the estimation of r t as infectors but not infectees. we used multiple imputation to allow for missing data on some symptom onset dates to make best use of all available data. we used a serial interval with mean (standard deviation) of ae ( ae ) days, and in sensitivity analyses, we used serial intervals with mean ae days and ae days. statistical analyses were performed in r version . . (r development core team, vienna, austria). in late april following the who global alert, hong kong initiated containment protocols to attempt to delay local transmission of ph n for as long as possible. these measures included screening at ports, airports, and border crossings, and enhanced surveillance for people with influenza-like illness, particularly for those who had recently returned from abroad. laboratory testing capacity was substantial due to heavy investment in local infrastructure following previous experiences with avian influenza a ⁄ h n in and severe acute respiratory syndrome in . laboratory-confirmed ph n cases were isolated until recovery, and their close contacts were placed under quarantine for days. imported cases were identified sporadically through may and early june . the first case of ph n not traceable to importation (i.e. a local case) was identified on june and triggered a change to mitigation phase measures. some containment measures, including isolation of cases, were continued until the end of june to allow a soft transition between containment and mitigation phases. as an immediate measure to try to reduce community transmission of ph n , all childcare centres, kindergartens, and primary schools were proactively closed for days (subsequently extended for another - days to summer vacation in early july). any secondary schools in which one or more confirmed ph n case was identified were reactively closed for days. on june the government opened eight designated flu clinics across the territory to provide free medical consultation for outpatients with influenza-like illness and free laboratory testing for ph n . these clinics resumed regular chronic disease services in mid-august, and laboratory testing and antiviral treatment was restricted to high risk groups in september. the various interventions are highlighted in figure (a), superimposed on the epidemic curve of laboratory-confirmed ph n cases and ph n -associated hospitalizations. around % of the cases were hospitalised, and this proportion increased somewhat towards the end of the epidemic. figure (b) shows the estimates of r t based on laboratory-confirmed ph n cases. the estimated r t peaked at ae on june , and fell below between june and july (which was within the school closure period). r t fluctuated between ae and ae through the school summer vacations in july and august, it subsequently increased to around ae - ae after schools reopened in september until the epidemic peaked in late september, and then fluctuated below as the epidemic declined. the trends in r t based on h n -associated hospitalizations were similar, although with wider confidence intervals due to the smaller number of events ( figure c ). the extension of the methods to allow for reporting delays avoided substantial bias in realtime estimates of r during the epidemic for the most recent days, and closely tracked the final estimates of r t . our results suggest that ph n may have had slightly lower transmissibility in hong kong than elsewhere. for example, estimates of r t were around ae - ae in new zealand and australia. lower transmissibility in hong kong has been associated with school closures in june and july followed by summer vacations from july through august. furthermore, in hong kong the influenza virus usually does not circulate after august, and therefore seasonality could also be a cause for the lower r t . on the other hand, the interventions applied during the mitigation phase, such as the widespread use of antiviral treatment in hong kong and the pre-existing immunity in the ageing population in hong kong, may also be associated with lower transmissibility. there are some limitations to our work. first, we only used aggregated data, and we did not consider the heterogeneity among the cases in terms of sex and age or other factors. therefore our estimates can only provide a snapshot of the overall trend, but limited information for any specific subset of population. secondly, we did not consider the possibility that cases might be infected in hong kong and exported to other countries, which could lead to slight underestimation of the transmissibility. one has to be careful in translating the estimated r t to the effectiveness of any specific interventions, as interventions may not be the only factor influencing the transmissibility; for example, a depletion of the susceptible population during an epidemic can also be a factor for the decline in r t . in conclusion, real-time monitoring of the effective reproduction number is feasible and can provide useful information to public health authorities for situational awareness and planning. in affected regions, laboratory capacity was typically focused on more severe cases, and changes in laboratory testing and notification rates meant that that case counts may not necessarily reflect the underlying epidemic. a useful alternative to case-based surveillance is surveillance of the subset of severe infections, for example hospital admissions, or icu admissions, and our results show that it was feasible to monitor ph n -associated admissions in real-time to estimate transmissibility. influenza antigenic cartography projects influenza antigens into a two or three dimensional map based on immunological datasets, such as hemagglutination inhibition and microneutralization assays. a robust antigenic cartography can facilitate influenza vaccine strain selection since the antigenic map can simplify data interpretation through intuitive antigenic map. however, antigenic cartography construction is not trivial due to the challenging features embedded in the immunological data, such as data incom-pleteness, high noises, and low reactors. to overcome these challenges, we developed a computational method, temporal matrix completion-multidimensional scaling (mc-mds), by adapting the low rank mc concept from the movie recommendation system in netflix and the mds method from geographic cartography construction. the application on h n and pandemic h n influenza a viruses demonstrates that temporal mc-mds is effective and efficient in constructing influenza antigenic cartography. the web sever is available at http://sysbio.cvm. msstate.edu/antigenmap. as a segmented, negative stranded rna virus, influenza virus is notorious for rapid mutations and reassortments. the mutations on the surface glycoproteins (ha and na) of influenza viruses are called antigenic drifts, and these antigenic drift events allow the virus to evade the accumulating immunity from previous infection or vaccination and lead to seasonal influenza epidemics. a reassortment event with a novel influenza antigen may result in antigenic shift and cause influenza pandemic. for instance, the h n pandemic virus is a reassortant with a swine origin ha antigen. vaccination is the primary option for reducing the effect of influenza, and identification of the right vaccine strains is the key to development of an effective vaccination program. the antigenicity of an optimal vaccine strain should match that of the epidemic strain. in influenza surveillance program, the influenza antigenic variants are generally identified by the immunological tests, such as hemagglutination inhibition (hi) assay, microneutralization (mn) assay, or elisa. these immunological assays measure the antigenic diversity between influenza viruses by comparing the reaction titers among the test antigens and reference antisera. however, data interpretation of the data from these assays is not trivial due to the embedded challenges such as data incompleteness, high noises, and low reactors. by mimicking geographic cartography, influenza antigenic cartography projects influenza antigens into a two or three dimensional map using immunological datasets. antigenic cartography can simplify the data interpretation, and thus, facilitate influenza antigenic variant identification. recently, we developed a novel computational method, temporal matrix completion-multidimensional scaling (mc-mds), in antigenic cartography construction. in this paper, we described the details of temporal mc-mds, especially the original concepts introduced in this method, and how they can achieve the robustness in antigenic cartography construction. our method included two integrative steps: it first reconstructs the hi matrices using low rank mc method, and then generates antigenic cartography using mds with a temporal regularization. the mc concept was adapted from the movie recommendation system in netflix and the cartography concept from geographic cartography. in , netflix, an online dvd and blu-ray disc rentalby-mail and video streaming company, held a -year netflix prize contest (http://www.netflixprize.com/) on computational methods for improving its recommendation system. in its recommendation system, netflix collected the rating data from the individuals. based on his or her renting history and the ratings in the systems (e.g., from evaluators and other renters), netflix recommendation system suggests certain movies to a renter. apparently, no individuals would be feasible to provide ratings for all of the movies, as it will take hundreds of years for a single person to rate over movies available from netflix. thus, the resulting rating data is an incomplete matrix, and it can be as sparse as less as %. the challenge in netflix recommendation system is a classic mc problem. [ ] [ ] [ ] [ ] [ ] as the inspiration of netflix prize contest, many efficient low rank mc algorithms were developed, for instance, opt-space, svt, cf, bellkor, pf, and fwls. eventually, the team bellkor's pragmatic chaos won this contest. their methods combines nonlinear probe blending and linear quiz blending to come up with a predictor bigchaos. matrix completion estimates the unobserved values based on the observed values. the users can refill the missing data without repeating the experiments. furthermore, mc will help reduce the noises in the data, for instance, those biases by different individuals performing experiments. in influenza antigenic characterization, hi assay is a commonly used assay for antigenic analysis, since hi assay is relatively economic and easy to perform. however, hi is labor intensive, and it is almost impossible for any individual lab to complete the hi assays for all pairs of antigens and antisera during influenza surveillance. in addition, both testing antigens and the reference antisera are dynamic. for instance, in seasonal influenza surveillance, generally only contemporary antisera are used in experiments. thus, we will have to integrate multiple hi tables in order to evaluate the overall antigenic changes for influenza vaccine strain selection. the resulting hi tables will be incomplete, and the observed entries in the integrated hi data can be as less as %. the completion of this matrix can be formulated as a typical mc. briefly, given the combination of hi matrix with m antigens and n antisera, the hi matrix can be represented as m m·n = (m ij ) m·n , where m ij denotes the hi values from the reaction between testing antigen i and antiserum j. the low rank mc assumes that both antigen and antiserum can be embedded into a low rank space. to be specific, the low rank mc method is to seek matrix u m·r , v n·r and a diagonal matrix r r·r , where m = u m·r r r·r (v n·r ) t . in order to achieve this goal, the optimization formulation has been employed, which can be represent as following, where e denotes the observed entries in hi matrix and g(x) is a regularization function. the eqn ( ) is the standard format of a low rank mc formulation. the geographic cartography is a common technique to display the cities and their geographic distances in a map. this cartography can be generated using mds based on a geographic distance matrix. figure (a) shows the antigenic cartography generated using a distance matrix with seven cities, and figure (b) is a map for comparison. as an analog of geographic cartography, the influenza antigenic cartography maps the influenza antigens into a two or three dimensional map based on the distance matrix generated using immunological data. this incomplete matrix can be filled through mc algorithm discussed in section mc and netflix. low reactors, non-random date incompleteness, and temporal model generally, three types of data are present in a combined hi matrix: high reactor, low reactor, and missing values. among these three data types, high reactors are the most reliable data points. the low reactors are those values present in the hi matrix as ''equal to or less than a threshold h'', where h can be , , , or . low reactors have similar values in the affinity dataset but could be from different binding settings. these low reactors are present due to the detection limits of biotechnology, and they are not reliable. both these missing values and low reactors make it very difficult to analyze and interpret antigenic correlations amongst tested antigens and reference antigens. to our best knowledge, none of the existing mc method can handle the threshold values. in addition, the non-random incompleteness of influenza immunological datasets generates an additional challenge in traditional mc methods, which are based on the assumption that the observed values are randomly distributed among the matrix. in a typical combined antigenic hi data, most of the off-diagonal entries are missing values or low reactor values. in order to overcome the above issues, we incorporated a regularization function into the eqn ( ), where this indicator function is only valid for those entries with low reactor values. an alternating gradient decent method is applied to solve the optimization problem in eqn ( ) . in addition, a temporal mds method is proposed to project the antigens into a or dimensional map. x where d ij is the average distance between virus i and virus j, t i is the isolation year of virus i, d ij is the distance between virus i and virus j in cartography, d ac i is the distance between virus a and center of group i, and d c i c j is the distance between the centers of group i and group j. all the parameters are tuned by cross validation. we named this method as temporal mc-mds. by applying temporal mc-mds method in an h n dataset, low reactors. figure (a) is a three-dimensional influenza antigenic map based on this data by using mc-mds method. the reported clusters (hk , en , vi , tx , bk , si , be , be , wu , sy , and fu ) were displayed in the core of a spiral s-shape, and bk and be are located at the turning point of this s-shape. however, the antigenic distances between some viruses are incorrect. for example, the distance between hk and fu in the projection is ae units, which is close to the distance between hk and bk ( ae units). the main reason leading to those inaccurate distances is the unique distribution of hi datasets described in section . . in comparison, with the temporal model, not only the viruses in clusters have been clearly separated, but also the antigenic distances between each cluster are proportional to their isolation time interval. in this updated cartography ( figure b ), the antigenic distance between hk and fu is ae units, where the distance between hk and fu is ae units. this result suggested that the temporal information is critical for antigenic cartography construction for immunological datasets spanning a long time period. the hi data from seasonal influenza surveillance belong to this category. for seasonal influenza virus ⁄ pandemic influenza viruses within a short time span, the temporal model is probably not necessary, as there is lack of long-term immunological pressure present in the population. figure (c) is an antigenic cartography generated using a hi dataset with h n influenza viruses spanning from april of to june of . this map demonstrates that there is lack of antigenic drifts during the first wave of this pandemic influenza as all of these viruses are mixed altogether. our limited studies on h and h avian influenza viruses suggested the temporal model is not needed for avian influenza viruses. however, extensive studies are required to investigate whether there is any special data structure present in this type of data. in this study, we described in details the concepts and applications of new computational method, temporal mc-mds for influenza antigenic cartography construction. we formulate the influenza cartography as two integrative steps: low rank mc problem from the concept of netflix movie recommendation system and mds from geographic cartography construction. in order to handle two additional challenges, including low reactor and non random distribution of antigenic data, a temporal model is incorporated into mc-mds as temporal mc-mds. our applications demonstrated that temporal mc-mds is effective in constructing influenza antigenic cartography. the three dimensional antigenic cartography for a ⁄ h n seasonal influenza virus without temporal model, and the antigenic clusters were defined in ref. [ ] ; (b) the three dimensional antigenic cartography for a ⁄ h n seasonal influenza virus with temporal model; (c) the two dimensional antigenic cartography for a ⁄ h n pandemic influenza without temporal model, and these viruses were labeled in shape by the corresponding month for them to be detected. one grid is corresponding to a twofold change in hemagglutination inhibition experiment. the mechanisms driving the three waves of infection and mortality in the uk in - are uncertain. although the circulation of three distinct viruses could have generated three waves of infection, the virological evidence required to prove or disprove this hypothesis is lacking. social distancing, an alternate mechanism for generating fluctuations in the effective susceptible pool and therefore explaining multiple waves of infection, , was not generally imposed in the uk as it was in the us and australia. we are therefore motivated to explore the possible role of continual population-level changes in the average protective response against the circulating virus in generating a multi-wave pandemic, within a biologically motivated deterministic model for influenza transmission. the nature and duration of protection against further infection following recovery from influenza is uncertain and depends on the mode and tempo of viral evolution, as well as the response of the cellular and humoral arms of the adaptive immune system. for a given seasonal ⁄ pandemic strain, memory b-cells may generate a specific antibody response in a portion of the adult ⁄ elderly population, depending on the exposure to related antigenic sub-types. however neutralising antibodies are unlikely to be a widespread immunological response to a novel (pandemic) strain. memory t-cells which recognise conserved internal viral proteins may be a more common mechanism for protection; the generation of very high levels of cytotoxic cd + t-cells potentially facilitates rapid viral clearance, , and lower levels of cd + t-cells perhaps provide partial protection. in this work we explore key drivers of multi-wave pandemics within phenomenological models that incorporate different immune response mechanisms building on existing models , incorporating the role of evolving population-level protection in multi-wave pandemics. we use weekly reports of influenza mortality rates for five administrative units in the uk (blackburn, leicester, newcastle, manchester and wigan) where records from block censuses instigated by local medical officers to record the cumulative incidence of reported symptoms in each wave in a sample of or more households are also available. the symptom reporting data allows us to estimate the case fatality rate and thus use the mortality time series to constrain our transmission model. furthermore, the incidence of individuals reporting symptoms in multiple waves provides information about the acquisition and loss of immunity. we extract the death rate and symptomatic (re)infection rates predicted by our model prevalence for a given set of parameters and estimate a likelihood-based on a comparison to all the death and cumulative reported incidence data assuming a negative binomial error distribution. we utilise monte carlo markov chain (mcmc) methods with parallel tempering algorithms to maximise this likelihood and obtain parameter estimates. parallel tempering -which concurrently searches for maximal likelihood parameter solutions on a set of scaled likelihood surfaces -allows for relatively rapid exploration of the parameter space. we use bayesian information criteria (combined with qualitative assessment of biological plausibility) to aid model selection. we have implemented a deterministic compartmental transmission model, which allows for a variety of phenomenological modes of protection against the pandemic virus. to facilitate this, we stratify the population into two groups; the 'experienced' population (stratum ) who have had been exposed to an influenza virus and the 'naive' population (stratum ) who have not. in each stratum, i hosts may be classified as either susceptible s i , exposed e i and e i , having (recovered from) a symptomatic i i (r i ), or asymptomatic a i (ra i ) infection. note that the states tq i , tq i , e i , t i , and t i are included so that the hosts move between the key epidemiological states with a peaked (rather than exponential) distribution of waiting times. hosts in the experienced stratum may exhibit reduced susceptibility, infectiousness, and symptomatic proportion compared to naive hosts, parameterised by e i , e s , and e a , respectively; however note that depending on the model parameters, there may be fully susceptible hosts within the experienced stratum. in addition, we assume homogeneous population mixing and a constant basic reproduction number r with the force of infection: modulated by a sinusoidal seasonal term with amplitude b with phase chosen to maximise transmission in the winter season. here n is the total population size, and x e is the initial fraction in the experienced strata. the proportion of symptomatic cases a and the case fatality rate l are permitted to vary from wave to wave (and given indices , or accordingly). the transmission dynamics is described by the following set of coupled ordinary differential equations. where s in, = p utq i and s in, = in order to divert recovered infectious hosts from the naive stratum into the experienced stratum. the probabilities of gaining permanent protection are q = q and q = . the latent exposed period is fixed to be c = ⁄ ae days, and the rate of recovery is parameterised by m = ⁄ t inf , where t inf is the infectious period. hosts with prior sterilising protection begin in q and move into s at rate u q = ⁄ t wq . recovered hosts (r i ) migrate back to s at a rate u = ⁄ t w . the state p contains hosts with permanent protection. the modes of protection captured in this model are: i. permanent prior protection (beginning in state p ), ii. waning prior protection (beginning in state q ), iii. permanent acquired protection with probability q (moving into state p ), iv. waning acquired protection with probability ) q, and, v. partial prior protection (beginning in state s ) resulting in reduced infectiousness (e i ), susceptibility (e s ), and symptomatic proportion (e a ). in the context of this model, 'permanent' protection refers to protection which lasts for the duration of the epidemic. here we explore the results of parameter fitting to two models which differ in the nature of the assumed pre-existing protection in the community at the beginning of the pandemic. protection hypothesis assumes that the prior protection is sterilising but temporary, whilst protection hypothesis assumes that the prior protection is partial but permanent and may act on susceptibility, infectiousness, and ⁄ or asymptomatic proportion. each model allows waning acquired protection and for a proportion q of the experienced population to gain permanent protection following infection. fitted parameters common to each model are t inf , b , q, t w , a, l and the proportion beginning in p x i . prior protection hypothesis : sterilising, waning prior protection we fix x e = and fit for q (t = ) ⁄ n and t wq so that protective modes i, ii, iii, and iv are enabled ( figure ). it is important to note that due to the slow convergence of the mcmc chains, we cannot guarantee that our parameter estimates correspond to the global minimum. furthermore, parameter estimates can only be meaningfully interpreted for good fits to the data. due to the prediction of a fourth (unobserved) wave for the model fit to blackburn, we do not report these parameter estimates here. the fits to the leicester data are generated with the parameter set r = ae , a = ae , a = ae , a = ae , t w = ae years, t wq = ae years, we fix q (t = ) ⁄ n = and fit for x e , e a , e i , and e s so that protective modes i, iii, iv, and v are enabled (figure ) . the parameters corresponding to the fit in figure for leicester are r = ae , a = ae , a = ae , a = ae , t w = ae years, p (t = ) ⁄ n = ae , s (t = ) ⁄ n = ae , b = ae , t inf = ae days, q = ae , e a = ae , e i = ae , and e s = ae . our model with protection hypothesis -which, similarly to the model discussed in ref. [ ] , assumes that a sub-population has waning sterilising prior protection -is able to generate multiple waves of infection via the continual replenishment of s from an initially large proportion (over %) of hosts with prior protection in q combined with the waning of acquired immunity in around % of cases on a time-scale of months. disease severity as measured by symptomatic proportion increases from % in the first wave to above % for the second and third waves. over a quarter of the population are initially permanently immune, and a large r value of ae drives transmission in the remaining population. protection hypothesis -which assumes that prior protection offers partial susceptibility and ⁄ or reduced infectiousness or symptomatic disease -performs slightly more poorly; the fit to the leicester data has an inferior likelihood (although the mortality data only likelihood is a little larger), despite the higher dimensionality of the model. nevertheless, the model fit still mirrors many characteristics of the data, particularly for leicester. we note that for this model, a is very near the lower limit, corresponding to ubiquitous exposure in the first wave. in this scenario, refuelling of the susceptible pool to generate secondary and tertiary waves is still possible due to a shorter waning time of acquired protection (well within months) and a lower probability of gaining permanent protection following infection, when compared with the parameter estimate for hypothesis . the parameter estimates suggest that approximately % of the population initially experiences reduced disease severity (e a $ ae ), but similar susceptibility and infectiousness. a larger value for r $ ae is required to drive transmission despite low numbers beginning in p , due to the large number of hosts who acquire temporary or permanent immunity early on in the pandemic. it is clear that, at least mathematically and perhaps biologically, there are multiple possibilities for the structure of population-level protection which are compatible with the generation of multiple pandemic waves. however, whilst the models considered here are able to explain the observed mortality and reinfection data for some patterns of infection and mortality (e.g. leicester), they are not consistently able to reproduce a pandemic which dies out after three waves across the connected populations we are studying (e.g. for blackburn). it is challenging to construct a deterministic model for the spread of disease within multiple locations in the uk in , which assumes homogeneous mixing without modulation of the transmission rate by social distancing. an improved model working with these assumptions likely requires a richer structure for the host protection response than the structures we have explored thus far. we are currently seeking improved fits to the data by implementing a number of biologically defensible exten-sions to our model, including incremental immunity whereby t w increases by a factor v after each exposure to the pandemic flu, and incremental loss of prior protection whereby a increases as hosts lose their sterilising prior protection. it is important to note that the mechanism(s) generating differences in the pandemic experience recorded in geographically connected locations is an open question; true differences in demography, varying degrees of reactive social distancing, inhomogeneities in the circulation (or circulation history, i.e. prior immunity) of viral strains, stochastic variations, and ⁄ or unique socio-cultural ⁄ behavioural conditions may all contribute to this effect. the h n experience in australia and elsewhere highlighted the difficulties faced by public health authorities in diagnosing infections and delivering antiviral agents (e.g. oseltamivir) as treatment for cases and prophylaxis for contacts in a timely manner. consequently, forecasts from mathematical models of the possible benefits of widespread antiviral interventions were largely unmet. we summarise results from a recently developed model that includes realworld constraints, such as finite diagnostic and antiviral distribution capacities. we find that use of antiviral agents might be capable of containing or substantially mitigating an epidemic in only a small proportion of epidemic scenarios given australia's existing public health capacities. we then introduce a statistical model that, based on just three characteristics of a hypothetical outbreak [(i) the basic reproduction number, (ii) the reduction in infectiousness of cases governments and public health agencies worldwide, spurred by outbreaks of sars and h n , have developed preparedness strategies to mitigate the impact of emerging infectious diseases, including pandemic influenza. pandemic response plans are presently being revised in light of the h n experience. [ ] [ ] [ ] many developed countries amassed large stockpiles of neuraminidase inhibitors (nais) with the expectation that they could be used to not only treat the most severely ill, but curb transmission in the community. without relevant field experience indicating how nais should be distributed, mathematical and computational modelling has been used to inform optimal deployment policy in a pandemic scenario. - models of population transmission were used to infer likely effects on epidemic dynamics, using data from human and animal studies of experimental infection and nai efficacy trials. in the australian (and wider) context, models indicated the potential for substantial benefit at the population level if nais were distributed in a liberal manner, targeting close contacts of indentified cases. furthermore, results indicated that use of limited nai resources in this way may improve the impact of case treatment due to the effects on epidemic dynamics. however, these models did not take into account logistic and other real-world constraints, such as finite diagnostic and antiviral distribution capacities, which were identified as limiting factors during the australian h n pandemic response. [ ] [ ] [ ] in particular, if using positive pcr diagnosis as a 'decision to treat' test, delays to confirmation of diagnosis, particularly once total laboratory capacity was exceeded, prevented timely delivery of nais to both cases and contacts of cases. in previous work, we have extended our existing models to examine how diagnostic strategies [e.g. using pcr confirmation versus syndromic influenza-like illness (ili) presentation as a decision to treat], diagnostic-capacity, and nai distribution capacity each impact on the ability to deliver an effective intervention. the model uses case severity (the proportion of infections deemed severe) to determine the overall presentation proportion, and so the ability to identify individuals eligible for nai treatment and contact prophylaxis. figure (a) shows a key result from the model. for each curve shown, we simulated thousands of epidemics, sam-pling across plausible ranges of parameters describing virus, population, and intervention characteristics using a latin hypercube sampling (lhs) approach. without intervention, the proportion of the population infected either symptomatically or subclinically by the end of the epidemic is around %. if a syndromic strategy (ili presentation) is used to determine provision of nais as treatment and prophylaxis, excessive distribution of drug to individuals who are not infected with influenza occurs early in the epidemic. early stockpile expiry accounts for a marginal impact of the antiviral intervention on the final outbreak size, in the order of a few percent. the second strategy modelled (pcr ⁄ syndromic) is one where pcr confirmation of diagnosis is required early in the epidemic to make treatment decisions until such time as laboratory capacity is exceeded. from this point, individuals are treated on the basis of symptoms alone -during an epidemic phase in which a substantial proportion of ili presentations will be attributable to influenza. under this strategy, the intervention is able to control the outbreak in approximately % of the simulated epidemics given the 'base case' constraints on diagnosis and delivery assumed in the model. the results highlight that a successful antiviral intervention requires a highly sensitive diagnostic strategy in the initial stages of the epidemic and comprehensive distribution of post-exposure prophylaxis. a pcr ⁄ syndromic strategy for decision to treat and provide contacts with prophylaxis is thus optimal. the surface in figure (b) shows the percentage of simulation runs for the pcr ⁄ syndromic strategy that have a final population attack rate of < % (a substantial reduction from the no intervention case of approximately %) as a function of pcr capacity and nai daily distribution capacity. as indicated by the arrow, the estimated australian pcr laboratory capacity appears to be sufficient, while significant benefits for the public health outcome may be achieved if logistical delivery constraints for nai distribution can be ameliorated. however, the probability that such an interventioneven with substantial increases in pcr and nai distribution capacity -would successfully mitigate an epidemic is low ( - %), and consequently it is difficult to universally recommend an antiviral intervention. in this study, we introduce a statistical model that predicts whether or not an nai distribution strategy based on a pcr ⁄ syndromic antiviral distribution policy will be successful in mitigating an epidemic. we thereby provide proof-of-principle for the design of a decision support tool that may be used by public health policy makers during an epidemic when faced with formulation of context specific nai distribution policy. synthetic data of hypothetical outbreaks and interventions were generated using the lhs simulations developed in ref. [ ] . we selected a random sample of outbreaks from a total of simulated epidemics ( % of model simulations). using these data, we identified independent model parameters that were most highly rank-correlated with the final attack rate. these parameters were included in a logistic regression model to assess their ability to predict whether an influenza epidemic would be successfully mitigated by an antiviral intervention (ar < %). model predictions were then validated against the full simulated dataset. full details of the simulation model, its structure, parameterisation and parameter distributions are available in ref. [ ] . use of the lhs simulation approach, and the method of model analysis and evaluation was similar to that previously described. matlab a (mathworks, natick, ma, usa) was used for the analysis and statistical model fitting. table shows results from our logistic regression model. key parameters sufficient to predict whether or not an outbreak may be controlled by the deployment of av agents are: . r , the basic reproductive number of the outbreak (assigned values between ae and ae for this example). as the value of r increases, the epidemic progresses more rapidly and is more difficult to control, explaining the negative correlation coefficient. . e t , the relative infectiousness of treated individuals (assigned values between ae and ae ). higher values for this parameter indicate only modest drug effects on transmission, explaining the negative correlation coefficient. . g, the proportion of infections that are severe (assigned values between ae and ae ), and which in turn determines the presenting proportion (derived values between ae and ae ). as the presenting proportion increases, the ability to identify and treat cases and deliver prophylaxis to contacts also rises, increasing the impact of the antiviral intervention. the roc curve ( -specificity versus sensitivity, not shown) for the logistic regression model specified in table has an area under the curve of ae , demonstrating that the model predicts the success of an antiviral intervention extremely well. for example, with a sensitivity of % we still have a specificity of approximately %. evaluation of the pandemic response has emphasised the need for early informed decision-making to implement proportionate disease control measures. our model identifies a low probability of successful epidemic mitigation using targeted antivirals alone (figure and ref. ), in distinction to results from models that fail to account for the diagnosis and delivery constraints inherent in any public health response. the decision support tool (table ) highlights key epidemic characteristics that are predictive of a high likelihood of effective mitigation. the reproduction number was one of the earliest parameters estimated from early outbreak data during the h n outbreak. , our findings reinforce the importance of characterising epidemic severity as early and as accurately as possible, in order to inform a proportionate pandemic response. critically, a typically mild pandemic (low g), such as that experienced in , is predictably difficult to contain using a targeted antiviral strategy due to the low proportion of infectious cases that present to health authorities. the relative infectiousness of treated individuals, e t , is strongly negatively correlated with successful mitigation, perhaps a surprising result given the model's underlying assumption (based on available epidemiological and human clinical trials data) that e t lies in the range [ ae , ]. that is, nais provided as treatment have a maximum impact of just a % reduction in infectiousness. however, our previous results show a strong synergistic effect of treatment when overlayed on a contact prophylaxis strategy, explaining the observation here that e t is critical in determining likely success of an intervention. despite the limited impact of treatment at the individual-level, the model outcomes are highly sensitive to the value of the relative infectiousness of treated cases. it follows that determination of e t is important for predicting the population-level outcome of a control effort. a 'small' reduction (of the order approximately %) may be extremely valuable in terms of success of a public health control strategy, and so should not be discounted. using a mathematical model which takes into account some of the key logistic constraints that are inherent to healthcare responses, we have derived a logistic regression model for estimating the probability that an antiviral intervention based on liberal distribution of nais as treatment and prophylaxis could successfully mitigate an influenza epidemic. the model demonstrates an excellent degree of accuracy when applied to synthetic data. the choice of parameters for the regression model was restricted to those that were both highly correlated with the success of the intervention and hopefully feasible to measure during the early stages of an emerging epidemic. the model could therefore be a useful near real-time decision support tool for public health policy in the face of an influenza epidemic, although further validation on a range of synthetic data (and real-world data where available) is required. influenza to seasonal flu status to avoid overstretching the demands on healthcare services. a great deal of information has emerged as the result of the pandemic response exercises conducted by affected countries. however, uncertainties remain regarding the effectiveness of intervention measures, as well as the feasibility and the timing of their implementation. mathematical and computational models [ ] [ ] [ ] have been used to project the outcomes of influenza outbreaks under various scenarios and epidemiological hypotheses. motivated by the events of and public health measures adopted by the taiwan cdc, we use a stochastic, individual-based simulation model to study the spatio-temporal transmission characteristics of the h n virus, so as to quantitatively assess the effects of early intervention strategies. our stochastic disease simulation model builds upon a highly connected network of individuals interacting with each other via social contact groups. to represent the daily interactions of approximately million people living in taiwan, we constructed a computer-generated mock population based on national demographic and employment statistics (to derive daily commute patterns) from the taiwan census (http://www.stat.gov.tw/). each individual is created with a set of attributes, including age, sex, residence, family structure, and social standing (employment status, etc.). based on their attributes and the time of day, each individual is assigned to miscellaneous contact groups, where the potential of interactions between any two individuals resulting in flu virus transmission occurs. such epidemiological properties are defined by empirically parameterized attributes such as basic reproduction number r , transmission probability, contact probability and associated probability distributions outlining the disease's natural history. additionally, intervention measures are implemented as scheduled events that could alter control parameters during the course of a simulation run. the targeted basic reproduction number (r ) in all our simulations is ae , following the suggested range by who of ae - ae . as the latent ⁄ incubation and infectious periods for h n have not yet been reliably ascertained, we adopt the natural history of the and pandemic influenza viruses. , here, the latent period ranged from to days, with a median value of ae days. the infectious periods begin day prior to symptom onset and can continue for - days, with a median value of ae days. twothirds of the infected individuals will develop clinical symptoms, and the asymptomatic cases will have half the infectious strength. the efficacy of antiviral drugs (oseltamivir) and vaccines are based on these studies. , for the source region of the infected cases, we use the north american continent (canada, mexico and united states) with an estimated total population of and an average hours of flight time to taiwan. the average daily passenger number is based on the annual statistical report on tourism, tourism bureau, taiwan (http://admin.taiwan.net.tw/english/statistics/year.asp? relno= ). each simulation lasts days and starts with a baseline simulation of r % ae h n pdm outbreak at the source region. the outbreak was adjusted to approximate clinical attack rate (car) in the united states, april -march , . we estimate the daily number of imported cases according to average daily passenger numbers and their probability of holding a disease status. we then apply airport exit ⁄ entry screening per corresponding success rates, by subtracting the number of identified symptomatic cases. we also consider latently infected passengers with inflight disease progression, by fitting a gamma distribution to the cumulative distribution of time to onset data with hours average flight-time, as presented by pitman et al. the daily imported cases are seeded according to the traveling patterns of foreign tourists and residents returning home. from the disease's natural history, we derive that roughly % of the infected travelers present no symptoms; the percentage increases if most symptomatic individuals elect not to travel in their condition, or are stopped by airport screening. we use the official epidemic data provided by the taiwan cdc to calibrate the simulation model and perform regression analysis on scenario parameters. this data is a close estimation of the weekly new clinical cases of h n pdm patients. it consists of weekly opd (outpatient department) icd- code (influenza) tallies collected by the bureau of national health insurance, taiwanadjusted to exclude seasonal flu patients and to account for uninsured patients. we formulate our scenario settings according to events in taiwan, and establish settings to approximate the actual events. with domestic events and intervention schedules fixed in time, the start date determines the simulation outcomes and the data range for selected indicators, such as the mean car, the epidemic peak, and several significant dates for the incoming index case events. we plot the taiwan weekly h n opd cases alongside the weekly new clinical cases from our simulation results in figure . our simulations not only capture the epidemic trend, but also pick out the most likely date, may , for identifying the first symptomatic case at airport screening based on practical assumptions. we further analyze the effectiveness of various mitigation measures with february , as the empirical start date for h n pdm in north america. the simulation result confirms that by the time we identified the first symptomatic case at the border screening, infected cases had already made their way to the public. by our calculation, roughly four such cases had passed in each of our scenario settings, with the first case happening as early as weeks before detection. figure also highlights the importance of the timing for the implementation of mitigation measures; for example, a -day-delay of the identical intervention plan results in nearly an additional % of the population being infected. therefore, the rule of thumb for healthcare officials is to implement intervention measures as early as possible. in our study, we have ignored the possibility of inflight transmission and any false positive results by airport screening procedures. to assess the effectiveness of each mitigation strategy of interest and their combinations, we take the calibrated simulation model and perform simulation realizations for groups of scenarios containing only those intended mitigation measures, and analyze the averaged results. for example, in the airport exit screening policy only scenario, the first imported symptomatic case can be delayed up to months, and the epidemic peak can be delayed up to days. as the data suggests, the exit screening policy alone has very little impact on car. combining various screening success rates for both exit and entry screening allows us to quantitatively assess their beneficial ramifications on the epidemic. for example, there is very little additional benefit between % and % suc-cess rates for entry screening policies when exit screening policies are adequate, as the enhanced border screening only delayed the epidemic peak by day, and reduced car by < ae %. base on this result, the government should not attempt to exhaust all its resources in securing the border during a pandemic event, because the return of such a policy will be disappointing. instead, a response plan with a shifting focus on health resource allocation and the capacity of adjusting intervention strategies in line with the developing epidemic will be most effective. based on the same principle, we perform experiments with assorted scenarios, including relaxing entry screening policies after identifying the first imported symptomatic case, mass vaccination based on the actual vaccination schedule of h n pdm in taiwan, and altering the start dates of the vaccination schedule. our results show that with a reasonable reduction in the airport entry screening success rate, we conserve valuable healthcare resources, but loose a few days for the strategic planning and preparation of subsequent response measures. in other simulation scenarios, a national vaccination campaign has very little impact on the outcome, due to the late start of the vaccination schedule. we then explore the effect of a national vaccination campaign with various starting dates. the simulation results are illustrated in figure , where the benefit of an early start date for mass vaccination is clearly demonstrated. considering a scenario with an % airport exit screening success rate, % airport entry screening success rate and % symptomatic case tracing success rate, the combined intervention strategy results in: a % reduction in car if the vaccination campaign starts in mid-november; % reduction if the campaign starts in mid-october; % reduction if the campaign starts in mid-september; and % reduction if the campaign starts in mid-august. in retrospect, the taiwanese government's response to h n pdm proved to be effective. first and foremost, it initiated enhanced border monitoring and on-board quarantine inspection as soon as the threat of a flu pandemic became clear. at the same time, the domestic preparations towards h n pdm were escalated, such as antiviral drug stockpiling and distribution, and vaccine acquisition. as the h n cases increased worldwide, various revised plans were adopted and implemented; such as the shift from labor-extensive on-board quarantine inspection to the notifiable infectious disease reporting system and realtime outbreak and disease surveillance system in order to effectively track down symptomatic and exposed passengers, apply prophylaxis treatment and mandatory in-home quarantine. as a result, all h n pdm related statistics are well below the international average. in modern society, countries rely heavily on the global economy for their own prosperity. shutting down the border for any length of time is not only costly, but could have disastrous economic effects that linger long after the event is over. moreover, with nearly % of the infected passengers presenting no symptoms whatsoever, they are not detectable by any port authority's screening procedures, and the importation of the novel flu virus is therefore inevitable. many studies conclude that entry screening is unlikely to be effective in preventing or delaying the importation of influenza, and has negligible impact on the course of subsequent epidemic. however, these studies are based on the assumption that effective exit screening is in place. our study shows that as the exit screening success rate decreases, the sensitivity of the entry screening policy becomes more pronounced. with the same methodology, we can also study the effects of varying the length of flight time, or the disease's incubation time. lastly, the benefit of entry screening is even more crucial for a small island country such as taiwan, since all incoming traffic must go through the port authority where entry screening can be enforced. in england and wales, three waves of the pandemic struck in summer, autumn, and winter seasons of - . although the proportion of people reporting symptoms was often greater in the first wave, - a puzzling feature was the much higher mortality in the second wave, in which . % of the population died, compared with . % in the out-of-season first wave and . % in the third wave. an obvious hypothesis to explain the changes in mortality from wave to wave would be that the virus mutated to higher virulence after the (lower mortality) first wave. although pandemic virus reconstituted from the high mortality waves has proven to have high virulence in animals, it has not been possible to recover virus from the first wave in for comparative purposes. indeed it is questionable whether virulence mutation(s) occurring between wave and wave could have spread to so many different populations in the time-frames observed. furthermore, in all three pandemic waves, there was the same agedistribution of mortality, with more deaths occurring amongst younger adults than older adults. [ ] [ ] [ ] this 'pandemic signature', arguably due to immune protection of older adults who were exposed to a similar virus in the years before , , suggests that the - viruses were at least immunologically similar in all three waves. a second hypothesis would be that the higher case fatality in the later waves was due to higher rates of complicating bacterial pneumonia, to increased transmission of influenza virus in the cooler months of the year, or to other seasonal effects. we have considered a third (immunological) hypothesis to explain the greatly increased mortality in waves and . the underlying idea is that the mortality rate in the first wave was lower than in later waves because most persons were protected by prior immunity in the first wave, and that the mortality was higher in later waves because of waning of that short-lived immunity. this hypothesis builds on our earlier modelling papers suggesting that even before the first wave in , military, school, and urban populations in england and wales apparently had (short-lived) immune protection, presumably induced by recent prior exposure to seasonal influenza. [ ] [ ] [ ] we suggest that this short-lived strain-transcending protection was in addition to the longer-lasting immunity, presumably induced by exposures to a similar virus circulating prior to , that arguably reduced pandemic mortality for older adults in - . , cumulative mortality rates attributed to pandemic influenza were available for each of the three waves in - for populations in england and wales. we have built immunological models to potentially explain the variation in mortality rates across waves and populations. to show proof of principle, we have fitted these models to mortality data from a randomly selected sub-set of twenty populations. our key assumption was that the risk of a fatal infection would be limited to persons with inadequate immunity who were being exposed to the pandemic virus for the first time. persons who were exposed and who survived an earlier wave were assumed to be protected against death in a later wave. model a and assumptions (see figure ) before the first wave, we assumed that people could be fully susceptible (s ), or partially protected (q ), or fully protected (p) by prior immunity which was not necessarily specific for the new virus. we assumed that exposure to the new pandemic virus would be fatal (m) in a proportion h of fully susceptible persons who were actually exposed (e) in the relevant wave. for those surviving that first exposure, it was assumed that they would be permanently protected against death in later waves by an immune assumed that viral exposure and multiplication would induce an immune response specific for the pandemic virus that would protect them against death in that wave and in subsequent waves. in contrast, for persons with strong prior immune protection, p, the virus would not be able to multiply to induce pandemic-specific immune protection. between waves, it is assumed that due to the waning of non-specific prior immunity, persons in the p state can move to the q state, and persons in the q state can move to an s state before the next wave. the proportion (e) of susceptible persons exposed to productive infection in each population was estimated by applying the following version of the final size equation to the proportion susceptible (s & q) in each wave, for each population: note: in both figures and , we have omitted the flows out of the q and e states that removed persons from the risk of death. parameters: s = proportion fully susceptible to infection and death before wave ; q = proportion susceptible to immunising infection, but not to death from exposure in wave ; p = proportion temporarily protected against both immunising infection and death from exposure in wave ; n = proportion even more protected against both immunising infection and death from exposure in wave (model b only); r = basic reproduction number (the average number of secondary cases for each primary case) in a fully susceptible population; f = proportion moving from q to s between waves; g = proportion moving from p to q between waves; d = proportion moving from n to p between waves (model b); h = proportion of e that actually move to m and die. model a could provide a very good fit for the summer, autumn, and winter waves of the - pandemic (results not shown). however, because of the replenishment of the pool of susceptible persons over time, model a also predicted a fourth wave of influenza in the spring season of . as no such wave was seen, and as we could not find parameters values for model a that did not predict a fourth wave, we must regard model a as inadequate. model b was similar to model a, but with an additional stage of prior immunity (n), which could wane to p. model b allowed us to not only fit the three observed waves, but also to fit the imputed data (zero cases) corresponding to the absent fourth wave. following earlier work, , we used a bayesian approach with markov chain monte carlo (mcmc) procedures to estimate model parameters, and we used hyper-parameters to allow for parameter variation between populations. the initial conditions were specified by the parameters: p , q , s and n . from these and the other parameters, it was possible to simulate the behaviour of model a over three waves, and of model b over four waves, and to estimate the expected numbers dying in each wave in each population. we calculated the log likelihood of the observed numbers of deaths given the parameter estimates, and we used mcmc simulation to generate the posterior distributions of parameters. although we obtained an excellent fit between observed and expected numbers of deaths in each of the three waves for the populations for model a, we could not find parameter values for model a that would fit the three observed waves without giving rise to a fourth wave in the spring of . accordingly, in the modified model b, we allowed for an additional stage of prior immunity (figure ) , and we fitted the model to the same data, plus imputed data corresponding to 'the absent fourth wave'. we obtained a very good fit to the three observed waves and the absent fourth wave in each population. the % credibility intervals for parameter estimates, derived from the posterior distributions of the hyper-parameters were: h = . - . , s = . - . , q = . - . ; n = . (fixed); p = ) s ) q ) n ; f = . - . ; g = . - . ; d = . - . and r = . - . . this analysis had allowed all parameters to vary from population to population under the constraints of the hyper-parameters. however, several of the biologically determined parameters might be expected to be more constant from population to population, whereas those dependent on mixing history and other social characteristics which vary more widely from population to population. to test this possibility, we fixed the mean values for the more biological parameters (f = . ; d = . ; g = . ) and estimated the % credibility intervals for the others as: h = . - . ; s = . - . , q = . - . ; and as before n = . (fixed); in a subsequent paper we will be able to provide more details of the method, the robustness of the assumptions, and the results from fitting to many more populations. this short report suggests that the observed patterns of mortality in england and wales over the three waves of the - influenza pandemic , can be explained by an immunological model. in particular, the lower mortality in wave one can be explained by the assumption of protective immunity antedating the first wave, arguably induced by prior exposure to seasonal influenza. , the much greater mortality in wave two can be explained by the waning, between wave one and wave two, of that short-lived and less-specific immune protection. the somewhat lesser mortality in wave three and the 'absent fourth wave' can be explained in terms of the progressive acquisition of immunity specific to the pandemic virus. the credibility estimates for parameters are of potential interest. for example, r estimates of . - . across different populations are consistent with our earlier findings. , if all persons had been susceptible, such r values imply that the virus would have infected most people in all populations. however, even in the first wave, the proportion susceptible, s + q , was < % in all populations, so that a considerable number of persons escaped productive infection in that wave; as their immunity waned, they became susceptible to infection in the later waves. it is likely that the variation in r between populations is due to different rates of population mixing. estimates for h indicate that between % and % of infections in the most susceptible persons were fatal; the higher values of h could reflect higher rates of secondary bacterial infection in the most socially disadvantaged and overcrowded populations. although we have shown the plausibility of an immunological explanation for wave to wave changes in pandemic mortality, we cannot assume that our particular model is even approximately correct. nor can we exclude the possibility that the higher mortality in the later pandemic waves in - was because of genetic change in the virus in later waves, or because of changing rates of secondary bacterial infection or seasonal effects. nevertheless, there is growing evidence that the population spread of pandemic influenza, whether in - , or in , , can be constrained by significant prior immunity, even for viruses that are ostensibly novel. previous reports, reviewed in ref. [ , ] , support the idea of strain-transcending immune protection, which can wane over periods of a few months. this form of protection, probably induced by recent exposure to seasonal influenza, may not be mediated by hi or neutralizing antibody. in contrast, strain-specific immunity, most often mediated by hi or neutralizing antibodies can be so long-lasting that after several decades it will still provide significant protection against any closely-related virus that re-appears in the population. it has not escaped our notice that although attack-rates in the h n pandemic were low in many countries, with generally mild symptoms, the virus did cause lifethreatening illness in a small proportion of younger affected persons. it seems likely that those who were most severely affected in were doubly unlucky: they had missed out on seasonal influenza infection or vaccination in the preceding season(s), and they were born too late to have been protected by the closely-related viruses that are thought to have circulated before . during the early phases of the influenza pandemic in italy, real-time modeling analysis were conducted in order to estimate the impact of the pandemic. in order to evaluate the results obtained by the model we compared simulated epidemics to the estimated number of influenza-like illness (ili) collected by the italian sentinel surveillance system (influnet), showing a good agreement with the timing of the observed epidemic. by assuming in the model mitigation measures implemented in italy, the peak was expected on week ( % ci: , ). results were consistent with the influnet data showing that the peak in italy was reached in week . these predictions have proved to be a valuable support for public health policy makers for planning interventions for mitigating the spread of the pandemic. mathematical models have recently become a useful tool to analyse disease dynamics of pandemic influenza virus can-didates. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] as of april , after the pandemic threat emerged worldwide, it was crucial for policy makers to have early predictions on the possible spread of the pandemic influenza virus in order to support, with quantitative insight into epidemic, policy decisions. thus, after the first pandemic alert was announced by the world health organization (who) in late april , a national crisis management committee headed by the minister of health was established in italy in order to provide weekly advice to the italian ministry of health. real-time analyses using an individual based model were undertaken. the transmission model was previously used for evaluating the effectiveness of the control measures adopted in the national pandemic preparedness plan and for assessing the age-prioritized distribution of antiviral doses during an influenza pandemic. to parameterize the transmission model, we used data derived from the national surveillance system until june and estimates of key epidemiological parameters as available at that time. in order to provide a preliminary assessment of the model predictions performed during the early stages of the epidemic, we compare model predictions with surveillance data of influenza-like illness (ili) available since august . after the first pandemic alert was announced by the who in late april , a national active surveillance system for the pandemic influenza was set up from april to july . however, over the period from april to october , surveillance systems, laboratory testing, and diagnostic strategies have varied considerably in italy. since end of july , following who recommendations, the focus of surveillance activities has changed in reporting requirements, as active case-finding became unsustainable and unnecessary. for this reason, the ministry of health (ministry of health, available in italian at the website: http://www.normativasanitaria.it) requested regional health authorities to report the weekly aggregated ili cases according to a new case definition (sudden onset of acute respiratory symptoms and fever > °c plus at least one of the following systemic symptoms: headache, malaise, chills, sweats, fatigue; plus at least one of the following respiratory symptoms: cough, sore throat, nasal obstruction). by october , following the increasing number of cases, the sentinel influenza surveillance system (influ-net available at: http://www.flu.iss.it) became the official surveillance system for ili cases in italy (ministry of health, available in italian at the website: http://www. normativasanitaria.it). since , influnet is routinely based on a nation-wide, voluntary sentinel network of sentinel community based physicians in the regions and autonomous provinces of the country. incidence rates are, therefore, not based on consultations, but on the served population of each reporting physician each week. influ-net usually consists of an average of (range - ) general practitioners (including physicians and pediatricians) per year, covering about ae - % of the general population, (representative for age, geographic distribution, and urbanization level) reporting ili cases (according with a specific case definition). italian influnet surveillance system is part of the european influenza surveillance scheme (eiss). a stochastic, spatially explicit, individual-based simulation model was used. individuals are explicitly represented and can transmit the infection to household members, to school ⁄ work colleagues, and in the general population (where the force of infection is assumed to depend explicitly on the geographic distance). the national transmission model was coupled with a global homogeneous mixing susceptible-exposed-infectious-removed (seir) model accounting for the worldwide epidemic, which is used for determining the number of cases imported over time. regarding the epidemiological assumptions (e.g., length and shape of the infectivity period, which lead to an effective generation time of ae days), this study is consistent with refs [ , , , ] , but for the proportion of symptomatic individuals, which is assumed to be ae %. the basic reproductive number of the national transmission model was set to ae , according to the early estimates as obtained during the initial phase of the epidemic in mexico in a community setting. , we initialized our simulations through the global homogeneous mixing model in such a way that imported cases were generated until june . this gives a reliable way for fixing the time in the simulations and thus determining the timing of school closure and vaccination in the simulations. the model accounts for school closure for both summer and christmas holidays: we assumed that in these periods contacts among students decrease, while contacts in the general community increase, as in ref. [ ] . we also considered scenarios accounting for partial immunity in the population. in order to investigate the effects of recommendations of the ministry of health (confirmed cases coming from affected areas were isolated for - days, either in hospital or at home) established in the early phase of the pandemic (april-july ), we assumed that a fraction of the imported symptomatic cases were isolated on the first day after the symptoms onset. this recommendation was in place until july . we also assumed, according to the italian school calendar, that schools were closed from june to september for the summer holidays, and from december to january for christmas holidays. the effects of prolonged school closure were also investigated. when considering vaccination, we assumed weeks for the logistical distribution of doses of pandemic vaccine. since at the time of simulation specific recommendations regarding the administration of a single dose of pandemic vaccine from ema were not available yet, we considered the administration of vaccine doses month apart). the pandemic vaccine was considered effective after the administration of the second dose with a vaccine efficacy of %. we assumed the vaccine to be administered by priority, vaccinating first the target population accounting for essential services workers (including health care workers and blood donors), pregnant women at the second or third trimester, and at risk patients (with chronic underlying conditions) younger than years old. the vaccination coverage was assumed %. regarding antiviral treatment and prophylaxis, recommendations of the ministry of health in the initial phase of the epidemic were to administer antivirals to all confirmed cases and to their close contacts. we assumed that the surveillance system would be able to detect % of symptomatic cases. after july , recommendations changed and antiviral treatment was considered only for cases with severe complications and in case of local clusters. since it was difficult to establish the proportion of treated cases, we considered different scenarios: antiviral treatment from % to % of the symptomatic cases. consistently with ref. [ ] , both treatment and prophylaxis were assumed to start day after the clinical onset of symptoms in the index case. treatment was assumed to reduce infectiousness by %, whereas antiviral prophylaxis was assumed to reduce susceptibility to infection by %, infectiousness by %, and the occurrence of symptomatic disease by %. as of july , approximately confirmed cases have been reported to the italian surveillance system for pandemic influenza. during july, the sudden increase of ili confirmed cases suggests for sustained autochthonous transmission in italy. by analyzing the number of ili cases reported to the surveillance during the weeks from to , we found that the exponential growth rate was ae ⁄ week and thus we estimated the national reproductive number to be r = ae . this estimate of the basic reproductive number supports the choice of the value adopted in the model simulations (r = ae ). in the absence of intervention measures, the predicted cumulative attack rate was ae % ( % ci: ae , ae ), and the peak was expected on week ( % ci: , ) with a peak day incidence of ae % ( % ci: ae %, ae %). by assuming case isolation, antiviral treatment, and prophylaxis to % of symptomatic cases until july , the peak was expected on week ( % ci: , ). when considering ae % of natural immunity in the population aged more than years, the peak was expected week later than in the previous scenario, i.e., on week ( % ci: , ). to validate the model, we compared model predictions (which are based only on the available information on the early phases of the epidemic) with ili data (figure ). based on model predictions, we estimated the underreporting factor of influnet ranging from ae to ae , considering different scenarios. by aligning the simulations with the ili data adjusted by the underreporting factor, we can observe that almost all the points in the increasing phase of the epidemic lie within the % ci of the model results (both considering or not natural immunity). the decay phase of the simulated epidemics shows a small delay with respect to the ili data. when introducing single and combined mitigation measures, such as case isolation, antiviral treatment, prophylaxis, and vaccination in the model, results showed that even a low proportion of symptomatic cases treated with antiviral drugs could have led to a relevant reduction in the epidemic size (table ) . we simulated the planned italian vaccination strategy (begun on october ), obtaining a limited but not negligible reduction in the attack rate with respect to the scenarios accounting only for antiviral treatment. moreover, the effect of vaccination would be higher if coupled with antiviral treatment; vaccination would have no effect on delaying the peak incidence. model predictions produced in italy during the early phase of the pandemic influenza are in excellent agreement with italian surveillance data on the beginning of the epidemic (when case isolation, antiviral treatment of index cases, and antiviral prophylaxis to close contacts were implemented by the italian regional public health authorities) and are basically consistent with the influ- net data during the course of the epidemic. the model has been useful for predicting the timing of the epidemic, while it has overestimated the impact of the influenza pandemic for adult and elderly individuals. however, the disalignment is probably due to the model parameterization. based on literature values, , we assumed a similar fraction of cases in the different social contexts considered in the model (namely ⁄ in households, ⁄ in schools ⁄ workplaces, and ⁄ in the general community), since analysis on the relative transmissibility of the virus was not carried out for any country yet. we were also able to estimate an underreporting factor for the influnet data in the range ae - ae . if we focus our attention on the reporting factor computed by considering the total number of cases (instead of symptomatic cases), the resulting value lies in the range - ae %, which is in excellent agreement with the range estimated in ref. [ ] on previous a ⁄ h n influenza seasons, namely ae %- ae %. moreover, based on our results showing that vaccinating % of the italian population was more than adequate to mitigate the pandemic, the ministry of health decided to stockpile a limited number of vaccines. we have also shown that starting the vaccination program in october (or later) could have had only a limited effect on reducing the impact of the epidemic, although it may have been useful to prevent a possible second wave and to protect essential workers and at-risk patients. finally, our results have shown that antiviral treatment would have been the most efficient strategy to reduce the impact of the influenza pandemic, even with a limited antiviral stockpile. a population-wide passive immunotherapy program in this paper, we assume that convalescent plasma (cp) is efficacious in treating severe cases of pandemic influenza. under this premise, we test the hypothesis that a population-wide passive immunotherapy program that collects plasma from a small percentage of convalescent individuals can harvest sufficient cp to treat a substantial percentage of severe cases during the first wave of the pandemic. the proposed program involves recruiting adults (individuals age - years) to donate blood if they have experienced influenza-like symptoms more than weeks ago (to account for the time needed for neutralizing antibodies to build up). the blood samples would be screened for infectious diseases (including hiv, hbv, hcv, htlv, and syphilis, etc., as in routine blood donation screening) and neutralizing antibodies against the pandemic virus. donors whose blood samples are free of known infectious agents and contain a sufficiently high titer of neutralizing antibodies would then be invited to donate plasma by plasmapheresis or routine whole blood donation. qualified donors with higher titers may be given higher priority for plasma donation. in this paper, we use the demographic and logistical parameters of hong kong as a case study. see figure for a schematic of the proposed passive immunotherapy program. we examine the following questions regarding the logistical feasibility and potential benefits of the proposed passive immunotherapy program: (i) what percentage of convalescent individuals (donor percentage) is needed in order for the program to significantly reduce pandemic mortality? (ii) how many severe cases can be offered passive immunotherapy? (iii) what are the ratelimiting factors in the supply of passive immunotherapy? (iv) what are the epidemiologic and logistical factors that determine the demand-supply balance of passive immunotherapy? a more detailed presentation of our results is now available in ref. [ ] . transmission and natural history model for pandemic influenza we use an age-structured disease transmission model to simulate the spread of pandemic influenza. the natural history model is similar to that used by basta et al. , the most important parameter in characterizing the growth of an epidemic is the basic reproductive number r , which is defined as the average number of secondary cases generated by a typically infectious individual in a completely susceptible population. we consider values of r between ae and , which is consistent with recent estimates. , [ ] [ ] [ ] logistical model for the passive immunotherapy program we assume that q d (%) of to year-old individuals who have recovered from symptomatic infections of pandemic influenza donate their blood for screening t r = days after cessation of symptoms. follow-ups of convalescent individuals infected with h n pdm in an ongoing clinical trial of passive immunotherapy suggested that neutralizing antibodies level reaches maximal level around - days after recovery and stays at that level for months after. we assume that q s (%) of these donors are qualified for plasma donation of which q r (%) are recurrent donors who return to donate plasma every t w = days. screening involves both detection of infectious agents and neutralizing antibodies against the pandemic virus. the latter is the rate-limiting step because neutralization tests of pandemic viruses can only be done in a bsl setting. we assume that five bsl -trained technicians are available to test the blood specimens, each running viral neutralization tests in days. therefore, the capacity and turnaround time of blood screening are u s = and t s = days, respectively. hong kong currently has nine plasmapheresis machines which allow a maximal throughput of plasma donations per day (assuming -hour daily operation with each donation taking minutes). therefore, the capacity and turnaround time of plasmapheresis are u p = and t p = ⁄ days, respectively. collected cp are ready for use in transfusion after final quality check, which takes t q = days. we assume that r t plasma donations are required to treat one severe case on average. the expert panel of the abovementioned study of passive immunotherapy for h n pdm in hong kong suggested that r t < . we assume that p h (%) of symptomatic cases will be severe cases for whom passive immunotherapy is suitable. although p h will be smaller than the case-hospitalization rate (passive immunotherapy may not be suitable for some hospitalized cases), we assume that the two have similar ranges and consider p h ranging from ae % to %. because each severe case requires r t plasma donations on average, demand for cp is simply r t p h times the number of symptomatic cases. therefore, r t p h can be regarded as a single parameter, which we refer to as the lumped demand parameter. we define the outcome as the percentage of severe cases that can be offered passive immunotherapy by the proposed program during the first wave of the local epidemic. we refer to this outcome as treatment coverage and denote it by q. we consider the base case scenarios assuming q r = % and q s = %. in general, the treatment coverage q increases sharply as the basic reproductive number r and the lumped demand parameter r t p h decrease (figure a ). in particular, when r is large and r t p h is small, q is very sensitive to r t p h , but insensitive to r . similarly, when r and r t p h are small, q is very sensitive to both. with a donor percentage of q d = %, the proposed program can supply passive immunotherapy to more than % of severe cases (q > %) if r < ae and r t p h < ae %, but < % if r > ae and r t p h > ae %. in general, the treatment coverage q increases sharply as the donor percentage q d rises from %, but with rapidly decreasing marginal increase ( figure b ). when r < ae and r t p h < ae %, q > % even if q d is as low as %, which is comparable to the current average blood donation rate of ae donations per population in developed countries. when q d is > %, q becomes largely insensitive to further increase in q d in most scenarios. the treatment coverage q for q d = % is more than % that for q d = % across all values of r and r t p h considered in the base case. therefore, increasing the donor percentage q d beyond % has a relatively small impact on cp supply. this is because increasing q d can boost supply only when plasmapheresis is not yet the supply bottleneck. for the same reason, once the donor percentage q d has reached %, the treatment coverage q is insensitive to further increase in q d even when the plasmapheresis and screening capacity are doubled ( figure b , lower panel). we conduct an extensive multivariate sensitivity analysis to test the robustness of our base case observations against uncertainties in parameter values. we generate epidemic scenarios by randomly selecting parameter values from their plausible ranges using latin-hypercube sampling. although there are numerous model parameters, the treatment coverage q is mainly determined by three lumped parameters: (i) r t p h , which indicates the magnitude of demand; (ii) q s q d , which indicates the magnitude of supply; (iii) the initial growth rate of the epidemic r (results not shown). while the dependence of q on r t p h and q s q d is readily comprehensible, it is not obvious a priori that q depends on the natural history and transmission dynamics of the disease via only the initial epidemic growth rate. when the plasmapheresis and screening capacity are very large, the supply-demand dynamics is further simplified: the treatment coverage q depends on lumped demand parameter r t p h and the lumped supply parameter q s q d only via their ratio. finally, q becomes insensitive to q s q d when the latter increases beyond - %, which is consistent with our base case observations. our results suggest that with plasmapheresis capacity similar to that in hong kong, the proposed passive immunotherapy program can supply cp transfusion to treat - % of severe cases in a moderate pandemic (basic reproductive number r < ae , lumped demand parameter r t p h < ae %) when the donor percentage is - %. increasing the donor percentage beyond % has little additional benefit because cp supply is constrained by the capacity of plasmapheresis during most stages of the epidemic. increasing plasmapheresis capacity could significantly boost cp supply, especially when there is a substantial pool of recurrent donors to alleviate the dependence of cp supply on donor percentage. in an ongoing clinical trial of passive immunotherapy for h n pdm virus infection in hong kong, % of convales- cent individuals agreed to donate their plasma for the study. therefore, the donor percentage required by the proposed passive immunotherapy program ( - %) is likely to be feasible. in view of the logistical feasibility of such program, we recommend that further clinical studies are conducted to evaluate the safety and efficacy of passive immunotherapy as a treatment for severe cases of pandemic influenza virus infection. our study is based on the premise that cp will be efficacious in reducing morbidity and mortality associated with pandemic influenza. in theory, the polyclonal nature of neutralizing antibodies in cp would lower the probability of an escape mutant emerging in treated patients. further, besides providing neutralizing antibodies against the pandemic virus, cp also might carry antibodies to other bacterial pathogens, which might decrease the severity of coexisting bacterial infections. as such, cp not only might reduce the case fatality rate but might also increase the recovery rate and shorten duration of hospitalization of severe cases. the proposed passive immunotherapy program can thus significantly reduce the burden on the healthcare system, especially the intensive care unit, which will likely be stressed, if not overloaded, at the peak of an influenza pandemic wave, hence benefiting the general public and not only those receiving passive immunotherapy. although the hypothesized efficacy of cp has yet to be proven in clinical trials, our modeling results show that a public health system similar to that in hong kong has the capacity to support a population-wide passive immunotherapy program that can supply cp treatment to a substantial percentage of the severe cases in a moderately severe pandemic. we estimate that compared to other developed countries, hong kong has a relatively low plasmapheresis capacity. our conclusions regarding donor percentage needed and rate-limiting factors remain valid for plasmapheresis capacity ranging from % to % of what we have assumed in the base case (results not shown). our conclusions are robust against uncertainties in the natural history and transmission dynamics of pandemic influenza. our sensitivity analysis shows that the outcome depends on these epidemiological characteristics only via the initial growth rate of the epidemic. as such, our results are applicable not only to pandemic influenza, but also to other emerging infectious diseases for which the time-scales of disease transmission and antibody response are similar to that for influenza virus. the three determinants of treatment coverage (the initial epidemic growth rate, the lumped demand parameter r t p h , and the lumped supply parameter q d q s ) are all readily measurable in real-time during an epidemic. therefore, our methods and results can be used as a general reference for estimating the treatment coverage of the proposed passive immunotherapy program for a given plasmapheresis capacity. background highly pathogenic h n virus continues to pose a serious threat to human health and appears to have the capacity to cause severe disease in previously healthy young children and adults. at present, antiviral therapy by oseltamivir remains the mainstay for managing h n patients. while early treatment improves survival, approximately % of patients treated within days of illness still succumb to the disease. in addition to the role of viral replication, there is good evidence that the host proinflammatory responses contributes to h n pathogenesis. this suggests that both antiviral and immune-modulatory drugs may have a role in therapy. we previously demonstrated that cyclooxygenase (cox- ) plays a regulatory role in h n hyperinduced pro-inflammatory responses, and its inhibitor has potent effects at modulating this host response. now we demonstrate that, in addition to its immune-modulatory effect, a selective cox- inhibitor, ns- has a direct antiviral effect against h n infection. materials and methods human primary monocytederived macrophages or alveolar epithelial cells (a ) were pre-treated with ns- or drug-vehicle for hour before h n virus infection. h n viruses at multipicity of infection (moi) of was used to infect the cells. following virus adsorption for mins, the virus inoculum was removed, and the cells were washed and incubated in corresponding medium with ns- or drug-vehicle as controls for , , , , and hours post-infection. cells were harvested for rna isolation at hours post-infection to study viral matrix (m) gene expression. supernatants were collected for % tissue culture infection dose (tcid ) assay to determine the virus titers at , , , and hours after h n infection. results ns- was found to suppress virus gene transcription and infectious virus yield in h n -infected human cells. conclusion we demonstrate that a selective cox- inhibitor, ns- , shows an inhibitory effect on h n viral replication in addition to its immune-modulatory effect that could counter the detrimental effects of excessive proinflammatory cytokine production. the findings suggest that selective cox- inhibitors may be a therapeutic target for treating h n disease in combination with appropriate antiviral therapy. the emergence and spread of the highly pathogenic avain influenza viruses (h n ) in poultry and wild birds with repeated zoonotic transmission to humans has raised pandemic concern. at the time of writing, human cases have been reported with fatalities, an overall case fatality rate of around % (cumulative number of confirmed human cases of avian influenza a ⁄ (h n ) reported to world health organization updated to october ). our previous data demonstrated that cox- was markedly up-regulated in h n -infected primary human macrophages, and that it played a regulatory role in the h n hyperinduced host pro-inflammatory responses. such cytokine dysregulation is proposed to be a major contributor to the pathogenesis of h n disease in humans. with the use of selective cox- inhibitors, we found that the h n -hyperinduced cytokine response was significantly suppressed by the drug in a dose-dependent manner. selective cox- inhibitor is a form of a non-steroidal anti-inflammatory drug that selectively targets cox- , and it is an inducible enzyme responsible for inflammatory process and immune response. here, we report a novel finding of a direct antiviral effect of a selective cox- inhibitor, ns- , against h n infection in human primary macrophages and alveolar epithelial cells. taken together with our previous findings that suggest an immuno-modulatory effect that can modulate virus driven cytokine dysregula-tion, these findings highlight a role for cox- and its downstream signaling as potential novel targets for adjunctive therapy of severe viral pneumonia, such as that caused by h n . such therapy may be combined with conventional antiviral drugs. the h n virus used was a ⁄ vietnam ⁄ ⁄ ( ⁄ ) (h n ), a virus from a patient with h n disease in vietnam during . the viruses were grown and titrated in madin-darby canine kidney cells cells as described elsewhere. virus infectivity was expressed as tcid . all experiments were performed in a biosafety level facility. monocyte-derived macrophages: peripheral-blood leucocytes were separated from buffy coats of healthy blood donors (provided by the hong kong red cross blood transfusion service) by centrifugation on a ficoll-paque density gradient (pharmacia biotech) and purified by adherence as reported previously. the research protocol was approved by the ethics committee of the university of hong kong. macrophages were seeded onto tissue culture plates in rpmi medium supplemented with % heat-inactivated autologous plasma. the cells were allowed to differentiate for days in vitro before use in the infectious experiments. alveolar epithelial cells: a cells were obtained from atcc and maintained in culture using dulbecco's modified eagle medium supplemented with % fetal calf serum, . mg ⁄ l penicillin, and mg ⁄ l streptomycin. differentiated macrophages or a cells were pre-treated with a selective cox- inhibitor, ns- (cayman), at concentrations as indicated or drug-vehicle for hour before infection. cells were infected with h n viruses at moi of . following virus adsorption for min, the virus inoculum was removed, the cells were washed and incubated in corresponding medium with ns- or drug-vehicle as controls throughout the experiments. cells were harvested for rna isolation at hours post-infection to study viral m gene expression. supernatants were collected for tcid assay to determine the virus titers at , , , and hours after h n infection. total rna was isolated using the rneasy mini kit (qiagen) according to the manufacturer's instructions. the cdna was synthesized from mrna with poly(dt) primers and superscript iii reverse transcriptase (invitrogen). transcript expression was monitored by real-time pcr using power sybr Ò green pcr master mix kit (applied biosystems) with specific primers. the fluorescence signals were measured using the real-time pcr system (applied biosystems). the specificity of the sybr Ò green pcr signal was confirmed by melting curve analysis. the threshold cycle (ct) was defined as the fractional cycle number at which the fluorescence reached times the standard deviation of the base-line (from cycle to ). the ratio change in target gene relative to the b-actin control gene was determined by the )ddct method as described elsewhere. ns- reduced the viral m gene expression in h n infected human macrophages in a dose-dependent manner ( figure ) . similarly, production of infectious virus yield in h n infected macrophages was found to be suppressed in the presence of ns- at lm compared to vehicletreated cells (figure a) . a comparable effect of ns- was observed in h n -infected human alveolar epithelial cells ( figure b ). we have previously demonstrated that cox- expression was dramatically upregulated following h n infection in human macrophages in vitro and in epithelial cells of lung tissue samples obtained from autopsy of patients who died of h n disease. this suggests that cox- may be an important host factor involved in h n pathogenesis and also provide a possible explanation on why h n virus replication is susceptible to a selective cox- inhibitor. cox- was previously reported to play an important role in the pathogenesis of other influenza a viruses. an in vivo study has highlighted the importance of cox- in h n - infected mice. findings showed that infection induced less severe illness and reduced mortality in cox- knock-out mice than in wild-type mice. on the other hand, cox- knock-out mice had enhanced inflammation and earlier appearance of proinflammatory cytokines in the bal fluid, whereas the inflammatory and cytokine responses were dampened in cox- knock-out mice. these data suggests that cox- and cox- may lead to opposite totally contrasting effects on influenza h n infected mice. cox- deficiency is detrimental, whereas cox- deficiency is beneficial to the host during influenza viral infection. therefore in the present study, instead of blocking cox enzymes in general as reported by others, we have chosen ns- that selectively block cox- but preserve cox- activity and showed that this drug significantly reduced h n virus replication in a dose-dependent manner. taken together with our previous report suggesting its immuno-modulatory effects, we believe that selective cox- inhibitors and cox- signaling pathways deserve investigation as a promising approach for targeting therapy in h n diseases. however, a few reports have suggested the importance of cox- in the late stage of inflammation for the resulution of inflammation, [ ] [ ] [ ] and this raises concern whether inhibition of cox- may be harmful in treating diseases related to dysregulation of host inflammatory response such as acute lung injury, which is a leading cause of death in h n patients. we previously looked at the autopsy samples of lung tissues from h n patients and found that cox- expression was markedly up-regulated compared with that from persons who died of non-respiratory causes. moreover, data also demonstrated that pro-inflammatory cytokines, such as tnf-a, was markedly elevated in the h n infected lung autopsies. taken together, with the histo-pathological findings, which showed predominant features of exudative inflammatory phase in autopsy lung samples from h n patients, , we may therefore speculate that people who had fatal h n infection died during acute inflammation phase, and before the resolution could occur, especially for the cases with a short disease duration (< - days). in conclusion, the roles of cox- in both pro-inflammation and pro-resolution phases deserves detailed investi-gation. the timing of selective cox- inhibitor therapy in h n infected patients may be extremely critical. therefore a time-dependent study using selective cox- inhibitors on h n -infected animal models will be particularly important in order to address the effectiveness of this drug in treating h n disease. avian antibodies to combat potential h n pandemic and seasonal influenza highly pathogenic avian influenza a virus (hpaiv) strain a ⁄ h n with unprecedented spread through much of asia and parts of europe in poultry remains a serious threat to human health. passive immunization (transfer of protective immunoglobulins) offers an alternative and ⁄ or additional strategy to prevent and cure influenza. here, we report that virus-specific immunoglobulin y (igy) isolated from eggs of immunized hens provide protection in mice against lethal h n virus infection by neutralization of the viruses in the lungs upon intranasal administration. importantly, chicken eggs obtained from randomly selected supermarkets and farms in vietnam, where mass poultry vaccination against a ⁄ h n is mandatory, contain high levels of igy specific for a ⁄ h n virus. when administered before or after the infection, igy prevented and significantly reduced replication and spread of hpaiv h n and related h n strains. thus, the consumable eggs readily available in markets of countries that impose poultry vaccination against a ⁄ h n could offer an enormous source of valuable biological material that provides protection against a ⁄ h n virus with pandemic potential. the approach could be used to control seasonal influenza. since , hpaiv of the h n subtype has resulted in more than cases of laboratory-confirmed human infection in countries with a death rate of more than % (http://www.who.int/csr/disease/avian_influenza/). h n influenza virus remains a global threat because of its continued transmission among domestic poultry and wild birds. passive immunization (the transfer of antigen-specific antibodies (abs) to a previously non-immune recipient host) offers an alternative and ⁄ or additional countermeasure against influenza. development of human monoclonal antibodies (mabs) against h n influenza haemagglutinin (ha) using epstein-barr virus (ebv) immortalization of b cells isolated from patients infected with h n , phage display, humanized mabs, and human recombinant abs has been attempted. chickens produce a unique immunoglobulin molecule called igy that is functionally equivalent to mammalian igg. igy is found in the sera of chickens and is passed from hens to the embryo via the egg yolk. egg igy has been used to prevent bacterial and viral infections (see review ) of the gastrointestinal tract and recently for protection against pseudomonas aeruginosa infection of the respiratory tract of patients with cystic fibrosis (cf). the epidemic of hpaiv h n virus has resulted in serious economic losses to the poultry industry, mostly in southeast asia. therefore, many countries including china, indonesia, thailand, and vietnam have introduced mass vaccination of poultry with h n virus vaccines that controls the h n epidemic to some extent. chickens immunized with recombinant h and ⁄ or inactivated h n reassortant vaccines produced a high level of virus-specific serum antibodies (abs) and were protected from h n virus challenge. theoretically, these abs could be found in egg yolk and separated for use in humans to prevent and cure h n hpaiv infection and disease, respectively. here, we examined the possibility that igy isolated from consumable eggs available in supermarkets in vietnam, where mandatory h n vaccination has been implemented, provide prophylaxis and therapy of hpaiv h n infection in mice. six-to -week-old female balb ⁄ canncrl (h- d) mice (charles river and jackson laboratory) and hy-line . igy abs were extracted from egg yolks as previously described. the % egg infectious dose (eid ) was determined by serial titration of virus stock in eggs, and eid ⁄ ml values were calculated according to the method of reed and muench. human virus stocks were grown in mdck cells as described previously , with viral titers determined by standard plaque assay. the % tissue culture infectious dose (tcid ) of virus was determined by titration in mdck cells. the standard elisa was performed for detection of anti-igy in the sera of igy-immunized mice. fifty percent lethal dose (ld ) titers were determined by inoculating groups of eight mice i.n. with serial -fold dilutions of virus as previously described. for infection, ketamine-anesthetized mice were inoculated intranasally with a lethal dose with pfu ( · ld ) of a ⁄ pr ⁄ ⁄ (h n ) virus as previously described, · ld of vn ⁄ (h n ) or · ld a ⁄ aquatic bird ⁄ korea ⁄ w ⁄ (h n ) resuspended in ll pbs per animal. ketamine-anesthetized mice were treated intranasally with ll of igy before or after infection. mice were observed for weight loss and mortality. subsets of animals were scarified for virus titre. we found comparable hai titers in the sera and egg yolks obtained from a farm in vietnam that was participating in a national mass vaccination program. furthermore we found % of eggs purchased in randomly selected supermarkets in hanoi, vietnam containing h -specific igy. the hai and vn titers of pooled egg yolk igy are comparable with those of sera obtained from hens selected randomly from the farm that underwent supervised h n vaccination. in contrast, igy separated from eggs purchased in korean markets where poultry are not vaccinated against avian influenza h n has no detectable h -specific hai or vn activity. we first treated naïve mice intranasally with h n -specific igy before infection with hpaiv h n strain, a ⁄ vietnam ⁄ ⁄ , isolated from a fatal case. such treated mice displayed mild weight loss and recovered completely by the end of the first week after inoculation ( figure a ). when animals were treated once with h n specific igy after h n inoculation they exhibited minimal weight loss during the first week after inoculation, and virus titers in the lungs were substantial reduced at day after infection; however, % of treated mice succumbed to infection during the second week after inoculation ( figure b) . it is possible that not all the hpaiv a ⁄ h n viruses were neutralized upon the single treatment with igy, and escaping viruses can spread systemically to organs outside of the lungs. these viruses may reappear in lung tissue later when specific igy is absent. indeed, vn ⁄ virus injected intravenously or into the brain can spread to the lungs. to circumvent the virus escape, we administered multiple treatments with h n specific igy after the infection. as a result, all infected mice recovered completely by the second week post-infection ( figure c) , and virus titers in the lungs were substantially reduced to the level that seen in protected mice that received single prior-infection treatment ( figure d) . similarly, the protective efficacy of h n -specific igy was observed in mice infected with lethal dose of mouseadapted avian influenza virus strain a ⁄ aquatic bird ⁄ korea ⁄ w ⁄ (h n ). this virus shares . % nucleotide sequence homology with ha (h ) but has different na (n ) from the one used for mass immunization in vietnam (reassortant avian h n influenza virus a ⁄ goose ⁄ gd ⁄ -derived, strain re- ). the results indicate that h n -specific igy isolated from eggs purchased in markets have preventive and therapeutic effects against infection with hpaiv h n and the related strain h n . the findings suggest that while a single treatment with igy prior to lethal infection was sufficient to protect the animals from the infection, multiple treatment is required for complete therapeutic effect after infection with hpaiv such as vn ⁄ strain. we further examined the protective efficacy of igy isolated from eggs laid by hens immunized in the laboratory with heat-inactivated human influenza a ⁄ h n virus, a ⁄ pr ⁄ ⁄ . we found substantial levels of hai and vn abs in the sera and yolks derived from immunized hens. when naïve mice were administered intranasally with such anti-pr ⁄ igy at - hours before or after infection with lethal dose of pr ⁄ virus, they were protected from the infection or lethal disease, respectively. the virus titers in the lungs of a ⁄ pr specific igy-treated mice at day after infection were also significantly lower than those seen in untreated mice or mice receiving normal igy. intranasal administration is the most effective route as compared to oral or peritoneal or intravenous administration for protection against lethal challenge, and the presence of virus-specific igy in bronchoalveolar lavage (bal) is required for the protection. the results provide a proof-of-concept that intranasal administration of virus-specific igy prevents influenza virus infection and cures the disease. the concept could be applied to control influenza outbreaks including seasonal and pandemic influenza. the protection was correlated with hai and vn activities of the igy and reduced virus titers in the lungs after treatments, suggesting that the protection is mediated by vn. we asked if administration of igy in the respiratory tract induces anti-igy ab response in mice. if this is the case, the next question is whether pre-existing anti-igy abs block igy-mediated protection. indeed, significant levels of anti-igy were observed in animals that received single or multiple administration of igy. when igy-immune mice were treated with virus-specific igy before or after lethal challenge, the results were identical to those obtained from treated naive mice, indicating that pre-existing anti-igy abs do not interfere with the protection mediated by virus-specific igy. consistently, incubation with anti-igy serum did not interfere with hai and vn activity of the virus-specific igy, indicating that anti-igy abs do not block virus binding by virus-specific igy (figure ). the finding suggests that the igy treatment could be applied to persons who have developed anti-igy during the individuals' life, and such treatment strategy could be repeated if multiple treatment is required and ⁄ or necessary later on to protect infections with other pathogens. the approach using specific igy for prevention and therapy of hpaiv h n infection offers a practical alternative to immunotherapy using convalescent plasma and an additional therapeutic option to antiviral drugs since widespread drug resistance has been recently reported among influenza virus strains. igy is relatively stable. we found no change in protective activity after at least months storage at °c, and lyophilization does not affect the activity, making production of igy practical. the use of igy immunotherapy has many advantages, since igy does not activate the human complement system or human fc-receptors, which all are well-known cell activators and mediators of inflammation. we chose the water dilution method for preparation of igy. the method is simple, efficient and does not require any toxic compounds or any additives. such igy preparations by this method have been used in other human study. , eggs are normal dietary components, so there is minimal risk of toxic side effects, except for those with egg allergy. thus, our study demonstrated that influenza virus-specific igy can be used in passive immunization that provides great help for immunocompromised patients and elderly who have weaken immune response to influenza vaccines. importantly, the consumable eggs readily available in the markets of countries that impose mandatory h n vaccination offer an enormous source of valuable, affordable, and safe biological material for prevention and protection against potential h n pandemic influenza. parts of the information and data presented in this manuscript were previously published in http://www.plosone.org/ article/info:doi% f . % fjournal.pone. . the polyphenol rich plant extract cystus is highly introduction the ⁄ h n influenza a virus pandemic clearly demonstrates that influenza is still a major risk for the public health. although the pandemic swine origin influenza a virus (soiv) caused only mild symptoms, the control of the outbreak still remains difficult. even as vaccine is available against this virus, the possibility of reassortment between the pandemic and a seasonal or avian a ⁄ h n influenza virus strain is indeed a frightening, but a likely event. this reassortant strain might be able to transmit easily between humans causing fatal infections, and the current soiv vaccine might no longer be sufficient to protect against the reassorted virus. in such a case, we can only rely on effective antiviral drugs. today, neuraminidaseinhibitors, such as oseltamivir, represent the most common clinically approved medication against influenza a viruses. unfortunately, the frequency of reports describing the appearance of drug-resistant seasonal h n and also h n influenza a viruses dramatically increased in the recent past. [ ] [ ] [ ] [ ] drug resistance to the known antivirals highlights the urgent need for alternative antiviral compounds with novel defense mechanisms. recently, we have reported that a polyphenol rich plant extract, cystus , which showed antiviral activity against influenza a viruses in cell culture and in mice. , moreover, the antiviral activity of cy-stus against seasonal influenza virus and common colds was also demonstrated in humans. however, the efficiency of cystus against soiv and a ⁄ h n isolates was unknown so far. therefore, we investigated cy-stus effectiveness against the pandemic strain and seven natural influenza a ⁄ h n isolates detected in several avian species during ⁄ avian influenza outbreak. additionally, the potency of the most common neuraminidase inhibitor oseltamivir was also investigated against these isolates. here, we show that cystus treatment was effective in in vitro studies against soiv and a ⁄ h n influenza virus. viruses avian h n isolates were originally obtained from the bavarian health and food safety authority, oberschleissheim, germany. the soiv a ⁄ hamburg ⁄ ⁄ was obtained from the robert-koch-institut, berlin, germany. all h n viruses were further propagated in embryonated chicken eggs or mdck ii (h n v) cells at the friedrich-loeffler-institut, tübingen, germany. for the cytopathological effect (cpe) inhibition screening, in accordance with sidwell, mdck ii cells were infected with different viruses at moi of ae . virus-infected cells were then treated with antiviral compounds cystus from ae to lg ⁄ ml or oseltamivir from ae nm to mm. after incubation for hours at °c and % co , cells were fixed, and viable cells were stained with crystal violet. after extraction of crystal violet from viable cells with % methanol, the extinction was measured with an elisa reader. immediately before infection, mdck ii cells ( · cells ⁄ well) were washed with pbs and subsequently incubated with virus diluted in pbs ⁄ ba ( ae % ba) mm mgcl , ae mm cacl , penicillin and streptomycin to a multiplicity of infection (moi) of ae for minutes at °c. cystus was added in a concentration of lg ⁄ ml directly to the virus-stock and on the cell monolayer simultaneously with the infection. after minutes incubation period, the inoculums were aspirated and cells were incubated with either mem or mem containing lm oseltamivir. at indicated time points, supernatants were collected. infectious particles (plaque titers) in the supernatants were assessed by a plaque assay under avicel as described previously. in order to investigate the antiviral potential of cy-stus , ec values based on the inhibition of the cpe on mdck ii cells were determined for cystus and in addition for oseltamivir. the ec values for cystus ranged from ae to ae lg ⁄ ml. cystus demonstrated the highest sensitivity against the soiv, sn and mb isolates with ec values below lg ⁄ ml. compared to these virus strains, cystus showed a slightly increased ec value for gsb ( ae lg ⁄ ml). in contrast the ec values for bb and bb were notably elevated ( ae and ae lg ⁄ ml). thus, the weakest antiviral effect of cystus was observed against these two isolates. the ec values evaluated for oseltamivir ranged from ae to ae lm ( table ), indicating that bb ( ae ) and gsb ( ae lm) can be considered resistant against oseltamivir. to confirm these results we investigated the ability of cystus to block virus replication as published before. as a control, virus infected cells were treated with oseltamivir as described earlier. in the absence of the drugs all influenza strains showed similar growth properties (figure , black squares) . first progeny viruses were detectable between and hours post infection (figure , black squares) . treatment with cystus resulted in reduction of virus titers of all influenza virus strains (fig. a-h, open triangles) . surprisingly, oseltamivir failed to inhibit the replication of two h n influenza virus strains (gsb and bb ), supporting the data of ec values ( figure d+h , grey rhombes). we assessed the antiviral activity of cystus against the newly emerged soiv and seven avian h n influenza viruses. cystus showed efficient antiviral activity against the pandemic h n v strain and was effective to a wide range of h n viruses. furthermore, cystus demonstrated a broader and more efficient antiviral potential than oseltamivir. cystus treatment leads to a stronger reduction of progeny virus titers, and more importantly, cystus was effective against all tested viruses, while oseltamivir was unresponsive against two of seven a ⁄ h n viruses. even though the pandemic strain in general is still sensitive to oseltamivir treatment, there are increasing numbers of reports of emerging resistant variants. the treatment with cystus does not result in the emergence of viral drug resistance since the mode of action is an unspecific physical binding of the virus particle that is also beneficial to reduce opportunistic bacterial infections. , , cystus is an extract from a special variety of the plant cistus incanus, and it is very rich in polymeric polyphenols. it is well known that polyphenols exhibit protein-binding capacity. however, cystus exhibited no neuraminidase inhibiting activity. therefore, ingredients of cystus may act in a rather unspecific physical manner by interfering with the viral hemagglutinin at the surface of the virus particle as demonstrated before. while this prevents binding of the virion to cellular receptors, it does not block accessibility and action of the viral neuraminidase. since, infections with influenza a viruses are still a major health burden and the options for control and treatment of the disease are limited, plant extracts such as cystus should be considered as a new candidate drug for a save prophylactic and therapeutic use against influenza viruses. attenuation of respiratory immune responses by antiviral neuraminidase inhibitor treatment and boost of mucosal immunoglobulin a response by co-administration of immuno-modulator clarithromycin in paediatric influenza the antiviral neuraminidase inhibitor osv and zanamivir are widely used treatment options for influenza infection and are being stockpiled in many countries. although mucosal immunity is the frontline of defense against pathogens, the effects of neuraminidase inhibitor treatment on airway mucosal immunity have not been reported. the suppression of viral rna replication and viral antigenic production by these drugs may result in a limited immune response against influenza virus. macrolides, such as cam and azithromycin, have anti-inflammatory and immunomodulatory properties that are separate from their antibacterial effects. [ ] [ ] [ ] this study examined the impact of osv treatment on immune responses in the airway mucosa and plasma in mice infected with iav and pediatric influenza patients. we also assessed the immuno-modulatory effects of cam in influenza patients who were treated with or without osv. female ae -week-old weanling balb ⁄ c mice were nasally inoculated with pfu of iav ⁄ pr ⁄ h n at day . immediately after infection, mice were given lg of osv orally or vehicle at -hours intervals for days. the levels of virus-specific siga in nws and bronchoalveolar fluids (balf) and igg in plasma were measured by elisa as reported previously. a retrospective clinical study was conducted. for the study, children with acute influenza were recruited and grouped according to the treatment received: days treatment with osv (n = ), cam (n = ), osv + cam (n = ), and untreated (n = ). since parents in japan are well aware of the adverse effects of osv especially the neuropsychiatric complications, the decision on whether to administer osv or not and to prescribe cam was made by the parents and the attending paediatricians, based on their anti-viral and immuno-modulatory activity. , comparisons were made of the levels of siga against iav ⁄ h n and iav ⁄ h n , total siga, in nws and disease symptoms before and after treatment. anti-ha siga and total siga in nws of patients were determined from the standard regression curves with human iga of known concentration in a human iga quantitation kit (bethy laboratories). because an affinity purified human anti-ha-specific siga standard of each influenza a subtype is not available, the relative value of anti-haspecific siga amount was expressed as unit (u). one unit was defined as the amount of one lg of human iga detected in the assay system as reported previously. the concentrations of siga in individual nws were normalized by the levels of total siga (lg ⁄ ml). oseltamivir suppresses viral rna replication and viral antigenic protein production. to investigate the influence of daily treatment with osv on ha-specific mucosal and systemic immune responses, we analyzed ha-specific siga levels in nws and balf as well as igg levels in plasma at days and post-infection in mice treated orally with osv or methylcellulose (mc) as vehicle. the osv treated mice showed lower antibody responses in nws and balf than control mice treated with mc solution (table ) . significantly reduced ha-specific siga responses were particularly noted in the osv group at day , the period of maximal mucosal siga induction. the airway secretions and plasma from mice at day did not contain detectable levels of ha-specific antibodies. these findings were supported by other data whereby mice treated with osv displayed significantly lower numbers of ha-specific iga antibody-forming cells (afcs) in the nasal lamina propria, mediastinal lymph nodes, and lungs compared with mc-treated mice. these results clearly indicate that oral administration of osv downregulates ha-specific siga responses in mucosa. on the other hand, there were no significant differences in the elevated levels of ha-specific plasma iga and igg antibodies or the increased numbers of ha-specific iga and igg afcs in the spleen between osv-and mc-treated mice. taken together, these results implicated the oral administration of osv in a suppressed induction of haspecific siga responses in respiratory lymphoid tissues, although systemic ha-specific antibody responses were not significantly affected by osv. since cam up-regulates il- , a mucosal adjuvant cytokine in the airways, and promotes the induction of siga and igg in the airway fluids of mice infected with iav, , we assessed the impact of treatment with osv and ⁄ or cam on the levels of anti-influenza siga in nws and clinical status of influenza patients. the concentration ratio of table . anti-ha-specific siga to total siga in nws was expressed as titer: anti-ha-specific siga (u ⁄ mg) ⁄ total siga (lg ⁄ mg) · . figure shows changes in the anti-ha(h n ) siga ratio (titer) and fold of increase in siga titer in each patient during the -days' treatment for the four different treatment groups. it is noteworthy that, upon admission to the hospital, the siga titers were < in % of patients. during the days of treatment, rapid increases in the titers were observed in almost all patients in cam, osv + cam, and no treatment groups. in contrast, in the osv group, the anti-ha-specific siga titers remained unchanged or decreased in the majority of patients. the finding of significant low induction of anti-viral siga in the osv group was supported by the results of animal experiments. however, the addition of cam to osv augmented siga production and restored mucosal siga levels; % of patients treated with osv + cam showed > -fold increase in the titers during treatment. these observations suggest that cam stimulated the local mucosal immunoresponse in the nasopharyngeal region of patients treated with osv. the prevalence of disease manifestations was also analyzed. among the symptoms listed, a significant decrease in the prevalence of cough was recorded between the no treatment group and the osv + cam group and between the osv group and the osv + cam group (**p < ae ), despite the limited number of patients in each group. the duration of the febrile period was significantly shorter in the osv and osv + cam groups than the no treatment group. however, no significant difference was observed between the osv group and osv + cam group. it has been reported that osv does not affect the cellular immune responses, such as cytotoxic t lymphocytes and natural killer cells. however, the effects of osv on mucosal immunity have not been studied so far. the present study showed that osv treatment of mice infected with iav induced insufficient protective mucosal siga responses in the respiratory tract, although treated mice showed the similar levels of systemic igg and iga antibody responses in plasma to those in mice treated with vehicle (table ) . the observed effect of osv on mucosal immunity was probably due to a suppression of viral replication and viral antigen production in the mucosal layer. these observations in mice are further supported by our clinical reports of siga in nws and balf of osv treated influenza patients. the membered-and membered-ring macrolides have been found to possess a wide range of anti-inflammatory and immuno-modulatory properties, , and to be effective in the treatment of respiratory syncytia and iav infection. , the efficacy of low doses administered on the long term against pathogens that are insensitive to macrolides indicates a mode of action that is separate from their antibacterial activity. , , , in the present study, we evaluated the immunomodulatory effects of cam on mucosal immune responses in pediatric influenza. a decrease in the proportion of total siga that was anti-ha-specific siga during treatment was observed in . % of patients in the osv group (those represented by the dotted lines and closed diamonds in figure ), whereas an increase in the proportion was observed in most patients of the other groups (except for one patient of the untreated group). despite the low or unchanged induction of anti-ha-specific siga in the majority of osv-treated patients, the additional use of cam with osv boosted the mucosal immune response and restored local mucosal siga levels. we are currently engaged in detailed immunological studies of the effects of cam and osv on the levels of mediators controlling iga class switching in nws of influenza patients and airway secretion of mice infected with iav. further studies should clarify the boost mechanisms of cam and the suppression mechanisms of osv in iga class switching. our findings suggest the risk of re-infection in patients showing a low mucosal response following osv treatment and cam effectively boosts the siga production for protection of re-infection. to date there is an urgent need to develop new antivirals against influenza. most of the molecules reported target influenza proteins that acquire rapid mutations of resistance. the development of new molecules that have a broad antiviral activity and are not subjected to influenza mutation is of particular interest. our laboratory and others recently showed that proteases can participate to the innate immune response in the airways through the activation of a family of receptors called par. in particular, through the release of interferon, par agonists curbed viral replication significantly in infected cells. in this study, since erk activation is crucial for virus replication, we investigated whether par could inhibit virus replication through inhibition of the erk pathway. results showed that while influenza a infection alone or par stimulation alone induced erk activation, par stimulation does not inhibit erk activation in influenza infected cells. thus, par agonists may be a potential new drug against influenza viruses that could be used in combination with other anti flu therapy such as the inhibition of the erk pathway. respiratory tract-resident proteases are key players during influenza virus type a infection. , in addition to their direct activating effect on surface viral proteins, lung mucosal proteases can regulate cellular processes by their ability to signal through protease-activated receptors (pars). after cleavage of the receptor by proteases, the new aminoterminal sequence of par binds and activates the receptor internally. these receptors are highly expressed at epithelial surfaces, in particular in the lung, where human influenza virus replicate in vivo. pars are thus directly exposed to proteases present in the airways. among the four different pars, par acts as an antiviral through an interferondependent pathway. , thus, agonists of par are potential new drugs against a broad range of influenza viruses, which is in accordance with the broad antiviral action of interferon. however, the signalling pathway induced by par agonists in influenza a infected cells has still to be investigated. in this manuscript, we showed that influenza infection or activation of par induced erk activation, a crucial step for efficient virus replication. , however, par agonists do not impaired erk activation in influenza a virus infected cells. since the pathway of par protection is likely to be erk-independent, the use of anti erk molecules in combination with par agonists maybe of potential interest in future anti-influenza therapy. influenza viruses a ⁄ wsn ⁄ (h n ) (a kind gift from nadia naffakh) was used in the present study. mdck (madin-darby canine kidney) and the human alveolar type ii a cell were obtained from atcc and grown as previously described. for western blot analysis, the following antibodies were used: monoclonal antibody for phospho-erk ⁄ (t ⁄ y ) and for erk ⁄ antibodies from cell signaling technology (beverly, ma), horseradish peroxydase (hrp)-coupled rabbit polyclonal antibodies against mouse or rabbit igg from paris (compiègne, france). a cells were infected with iav at an moi of in emem medium, as previously described. , at various time points post infection, cells were collected and proteins were analysed as previously described. , par stimulation was performed at °c in emem medium as previously described. after infection and ⁄ or stimulation, cells were lysed in ice-cold lysis buffer. lysates were centrifuged at g for min, and total proteins of the supernatants were analyzed by western blot analysis as previously described. , results since activation of the erk pathway is essential for efficient influenza replication, we first investigated the kinetics of erk activation after influenza infection in human a alveolar epithelial cells. for this purpose, a cells were infected with influenza viruses at a moi of at different time point post-infection, and activation of erk ⁄ pathway was assessed by western blot analysis using an anti-erk antibody. results showed that erk was phosphorylated after influenza infection in a time course depen-dent manner when compared to uninfected cells. in contrast, erk phosphorylation was not observed with heatinactivated viruses, suggesting that productive infection is needed for erk activation ( figure a ). antibodies against erk ⁄ were used as controls. since erk is activated after influenza infection, we then tested whether activation of par in uninfected cells also leads to activation of this pathway. for this purpose, a cells were stimulated with the selective human (h) or mouse (m) par agonist or a control peptide for the indicated time ( figure b ). when exposed to the par agonists and compared to controltreated cells, erk phosphorylation increased over the time course of stimulation. thus, influenza infection or stimulation of par without infection in a cells induced activation of the erk pathway at different time point post-infection. since influenza infection and par stimulation induced erk activation, we then investigated whether par could inhibit erk activation in influenza infected a cells. results in figure showed that in influenza infected cells, par activation for ten minutes does not inhibit erk activation after influenza infection. thus, erk activation is not inhibited by par activation in influenza stimulated cells. in this manuscript, we studied the activation of the erk pathway after par stimulation and or influenza infection. particularly interesting is the fact that either influenza infection or par stimulation alone induce erk phosphorylation in a epithelial cells, while erk activation is not inhibited in a infected cells compared to uninfected ones after par stimulation. proteases are key factor in the pathogenicity of influenza viruses. in addition to the cleavage of ha, necessary for iav replication, extracellular proteases also play a role in the modulation of the immune system against influenza viruses through the activation of pars. particularly par , activated by extracellular trypsin-like proteases, could inhibit virus replication through the release of interferon, , thus, strengthening the immune system via agonist peptides and providing new therapeutic potential against a broad range of influenza strains. in addition, targeting the host instead of the virus could provide a way to escape from virus resistance. thus, a better understanding of how virus escapes from immune surveillance may provide new therapeutic strategies to block iav. in addition, combinations of drugs that block virus replication via different pathways are of interest. the non classical molecules hla-g maybe an interesting new target as we recently showed that it is upregulated after influenza infection, and it is a well known immunotolerant molecule. indeed, it inhibits the innate immune response as well as the adaptive immune response. , also, as previously suggested, the erk signal transduction cascade is also of potential interest since it is crucial for virus replication and particularly influenza replication. , as shown here, it is unlikely that par protection occurs through an erkdependent pathway. thus strengthening the immune response with par agonists and blocking nuclear retention of the viral ribonucleoprotein complexes with inhibitors of the mek ⁄ erk pathway may be alternative combinatory approaches for influenza therapy. in addition, since those potential drugs target the host instead of the virus, this could help in the design of new antivirals molecules more resilient to iav mutations and thus to virus resistance. the initial waves of the first influenza pandemic of the st century have passed. in june , vaccine companies estimated they could produce in months almost . billion doses of pandemic vaccine. instead, they actually produced only million doses, of which % were non adjuvanted preparations. had these doses been produced with adjuvants (i.e., . lg instead of lg ha per dose), an additional billion doses could have been made available. yet there was public opposition to adjuvants in many countries, especially by regulatory officials in the united states. misperceptions about the safety of both adjuvanted and nonadjuvanted vaccines were widespread. added to this, shortfalls in vaccine production, delays in vaccine delivery, and the ''mildness'' of the pandemic itself meant that only a few countries achieved reasonable levels of vaccine coverage. millions of doses went unused and had to be destroyed. supplies of antiviral agents were even more limited. thus, despite the best efforts of influenza scientists, health officials, and companies, more than % of the world's people did not have timely access to affordable supplies of vaccines and antiviral agents. instead, they had to rely on th century public health ''technologies.'' given current understanding of biology in the early st century, they should have had -and probably could have had -something better. this report reviews evidence for an alternative approach to serious and pandemic influenza that could be used in all countries with basic health care systems. instead of confronting the influenza virus with vaccines and antiviral agents, it suggests that we might be able to modify the host response to influenza virus infection by using anti-inflammatory and immunomodulatory agents. this idea was introduced several years ago and has been reviewed in several publications. [ ] [ ] [ ] [ ] [ ] [ ] the central importance of the host response in the pandemic, young adults had high mortality rates. ever since, influenza virologists have sought to answer the question ''why did young adults die?'' by defining the molecular characteristics of the virus that were responsible for its virulence. in doing so, they have overlooked a crucial piece of clinical evidence from the pandemic: compared with young adults, children were infected more frequently with the same virus, yet they seldom died. consequently, the more important question is ''why did children live?'' this can only be explained by recognizing that children must have had a different host response to the influenza virus than adults. physicians have long recognized that for several other medical conditions, both infectious (e.g., pneumococcal bacteremia) and non-infectious (e.g., multiple trauma), children have a more benign clinical course than adults. , a corollary of this observation is that secondary bacterial pneumonia, although commonly found in young adults in , could not have been the primary cause of death. children must have had the same or higher rates of nasopharyngeal colonization with the same bacteria that were associated with pneumonia deaths in adults, yet children seldom died of secondary bacterial pneumonia. if young adults died with secondary bacterial pneumonia, underlying host factors must have made them more susceptible. few people who die of influenza do so during the first few days of illness when pro-inflammatory cytokine levels are high. instead, like patients with sepsis, they usually die in the second week, when anti-inflammatory cytokines and immunosuppression dominate. , , influenza deaths occur more frequently in older persons with cardiopulmonary conditions, diabetes, and renal disease, but as seen in the h n pandemic, they also occur in younger adults with obesity, asthma, and in women who are pregnant. regardless of age, people with all of these conditions share one characteristic in common: they have chronic low-grade inflammation. in effect, their ''innate immune rheostats'' have been set at different, and perhaps more precarious, levels that make them more vulnerable to influenza-related complications. laboratory studies of influenza virus infection confirm the importance of the host response. in several studies in mice in which the host response has been modified (e.g., cytokine knockout), survival has been improved without increasing virus replication in the lung. in fact, severe disease can be induced without any influenza virus replication. for example, fatal acute lung injury has been induced in mice by inactivated (not live) h n virus. in this model, antiviral agents would be useless; only the host response could be responsible for disease. these observations raise the following question: could the host response be modified so patients with severe seasonal and pandemic influenza might have a better chance of surviving? influenza is associated with acute coronary syndromes, and influenza vaccination and statins reduce their occurrence. these associations led to the suggestion in that statins might be used to treat pandemic influenza. other agents that might also be effective include ppara and pparc agonists (fibrates and glitazones, respectively) and ampk agonists (e.g., metformin). , these agents have been studied in laboratory models of inflammation, sepsis, acute lung injury, ischemia ⁄ reperfusion injury, energy metabolism, mitochondrial function, and programmed cell death. the results of these studies cannot be reviewed in detail here, but the major findings for cell signaling are summarized in the table . unfortunately, the results of experimental studies are not always clear cut. for example, in one study of influenza virus infected mice, il- was necessary for containing infection, but in another study il- appeared to be harmful. nonetheless, overall understand-ing of cell signaling pathways in influenza virus infections and the actions of statins, glitazones, fibrates, and ampk agonists strongly suggest that these agents could benefit patients with severe influenza. laboratory studies in mice infected with pr (h n ) h n and pandemic h n viruses show that resveratrol, fibrates, glitazones, and ampk agonists reduce mortality by - %, often when treatment is started - days following infection. - (resveratrol is a polyphenol found in red wine. it shares with these other agents many of the same cell signaling effects.) in h n -infected mice, treatment with celecoxib and mesalazine, together with zanamivir, showed better protection than zanamivir alone. remarkably, these immunomodulatory agents have not increased virus replication. even more remarkable, in another model of a highly inflammatory and frequently fatal conditionhepatic ischemia ⁄ reperfusion injury -glitazone treatment ''rolled back'' the host response of ''young adult'' mice ( - weeks old) to that of ''children'' ( - weeks old). this unique study suggests that immunomodulatory treatment might roll back the damaging and sometimes fatal host response of young adults with influenza to the more benign and rarely fatal response of children. several, but not all, observational studies have shown that outpatient statins decrease hospital admissions and mortality due to community-acquired pneumonia. for influenza itself, preliminary evidence presented in october suggests that immunomodulatory treatment of influ- table . cell signaling targets that might be affected by immunomodulatory treatment of severe seasonal and pandemic influenza* down regulate pro-inflammatory cytokines (e.g., nf-kappab, tnfa, il- , il- ) up regulate anti-inflammatory cytokines (il- , tgfb) up regulate pro-resolution factors (lipoxin a , resolvin e ) up regulate ho- and decrease tlr signaling by pamps and damps up regulate enos, downregulate inos, restore inos ⁄ enos balance and stabilize cardiovascular function decrease formation of reactive oxygen species and decrease oxidative stress improve mitochondrial function and restore mitochondrial biogenesis decrease tissue factor and its associated pro-thrombotic state stabilize the actin cytoskeleton in endothelial cells and intracellular adherins junctions, and thereby increase pulmonary barrier integrity and decrease vascular leak differentially modify caspase activation and apoptosis in epithelial and endothelial cells, macrophages, neutrophils and lymphocytes in the lung and other organs increase the bcl- ⁄ bax ratio in influenza virus-infected cells and prevent the apoptosis necessary for virus replication. *see references , , , for details. nf-kappab, nuclear factor kappab; tnfa, tumor necrosis factor alpha; tgfb, transforming growth factor beta; ho- , heme oxygenase - ; tlr, toll-like receptor; pamp, pathogen-associated molecular pattern; damp, damage associated molecular pattern; enos, endothelial nitric oxide synthase; inos, inducible nitric oxide synthase. enza patients with severe illness could be beneficial. in a study of almost patients hospitalized with laboratoryconfirmed seasonal influenza, inpatient statin treatment reduced hospital mortality by %. in these patients, the cell signaling effects of statin treatment, summarized in the table , probably acted to reduce pulmonary infiltrates, maintain oxygenation, stabilize myocardial contractility and the peripheral circulation, reverse immunosuppression, restore mitochondrial biogenesis, and prevent multi-organ failure. achieving these clinical effects led to a decrease in mortality. because of the molecular cross-talk between statins, fibrates, glitazones, and ampk agonists, , similar clinical benefits might be expected from other members of this ''family'' of immunomodulatory agents. simvastatin, pioglitazone, and metformin are produced as inexpensive generics in developing countries. they are used throughout the world in the daily treatment of millions of patients with cardiovascular diseases and diabetes. global supplies are huge. because most people with influenza recover without specific treatment (this was true in ), not all patients would require immunomodulatory agents. instead, only those at risk of ards, multi-organ failure, and death would need to be treated. importantly, the cost of treatment for an individual patient would be less than $ . (d.s. fedson, unpublished observations). moreover, unlike vaccines they could be used on the first pandemic day. thus far, influenza scientists and the institutions that support their work (e.g., nih and cdc, national health agencies in many countries, the bill and melinda gates foundation, the welcome trust, and the world health organization) have shown little interest in immunomodulatory treatment. nonetheless, when more than % of the world's people have no access to influenza vaccines and antiviral agents, their physicians must have access to an effective ''option,'' especially one that might be lifesaving. research on immunomodulatory agents for influenza must involve investigators in many fields outside influenza science -those with expertise in the molecular and cell biology of inflammation, immunity, sepsis, cardiopulmonary diseases, endocrinology and metabolism, ischemia ⁄ reperfusion injury, mitochondrial function, and cell death. laboratory studies needed to identify promising treatment agents would probably cost $ - million (d.s. the results of these studies would inform clinical trials that critical care physicians are already eager to undertake. , this work will be especially important for people in developing countries where critical care capacity is extremely limited and not likely to improve. like critical care physicians, influenza scientists too must recognize that they cannot afford not to undertake research to determine whether generic immunomodulatory agents might be useful in managing severe seasonal and pandemic influenza. the nf-kappab-inhibitor sc efficiently blocks h n influenza virus propagation in vitro and in vivo without the tendency to induce resistant virus variants introduction influenza is still one of the major plagues worldwide. the appearance of highly pathogenic avian influenza (hpai) h n viruses in humans and the emergence of resistant h n variants against neuraminidase inhibitors highlight the need for new and amply available antiviral drugs. we and others have demonstrated that influenza virus misuses the cellular ikk ⁄ nf-kappab signalling pathway for efficient replication, suggesting that this module may be a suitable target for antiviral intervention. here, we show that the novel nf-kappab inhibitor sc efficiently blocks replication of influenza a viruses, including avian and human a ⁄ h n isolates in vitro in concentrations that do not affect cell viability or metabolism. in a mouse infection model with hpai a ⁄ h n and a ⁄ h n viruses, we were able to demonstrate reduced clinical symptoms and survival of sc treated mice. moreover, influenza virus was reduced in the lung of drug-treated animals. besides this direct antiviral effect, the drug also suppresses h n -induced overproduction of cytokines and chemokines in the lung, suggesting that it might prevent hypercytokinemia we hypothesise to be associated with pathogenesis after infections with highly pathogenic influenza viruses, such as the a ⁄ h n strains. thus, a sc -based drug may serve as a broadly active nontoxic anti-influenza agent. to assess the number of infectious particles (plaque titers) in organs a plaque assay using avicel Ò was performed in -well plates as described by mastrosovich and colleagues. virus-infected cells were immunostained by incubating for hour with a monoclonal antibody specific for the influenza a virus nucleoprotein (serotec) followed by minutes incubation with peroxidase-labeled anti-mouse antibody (dianova) and minutes incubation with true blueÔ peroxidase substrate (kpl). stained plates were scanned on a flat bed scanner and the data were acquired using microsoft Ò paint software. the virus titer is given as the logarithm to the basis of the mean value. the detection limit for this test was < ae log pfu ⁄ ml. organs of infected and control mice were homogenized and incubated over night in ml trizol Ò reagent (invitrogen) at °c. total rna isolation was performed as specified by the manufacturer (invitrogen). rna was solubilised in ll rnase free water and diluted to a working concentration of ng rna ⁄ ll. reverse transcription real-time pcr was performed using quantifastÔ sybr Ò green rt-pcr kit and quantitect primer assays (qiagen) . all samples were normalized to gapdh and fold expression analyzed relative to uninfected controls. ct values were obtained with the smartcycler Ò (cepheid). to answer the question whether the nf-kappab inhibitor sc shows antiviral properties against influenza virus, h n infected mdck cells were treated with different concentrations of the inhibitor (figure ). already treatment with nm of sc led to a reduction of viral cpe of more than %. almost % protection of cells was achieved when cells were treated with lm sc . the results indicated that sc has antiviral properties at concentrations ranging from to nm. we next tested whether sc would also be effective in the mouse model of influenza virus infection. when h n mice were treated i.v. once daily for days with mg ⁄ kg sc , survival rate of the animals increased significantly (p < ae ). the same results were found when h n influenza virus infected mice were treated i.p. with mg ⁄ kg sc (data not shown). moreover, sc treatment was not only effective when the inhibitor was given prior to h n influenza virus infection, but also in a therapeutic setup when sc was applied to the animals days after infection (data not shown). since influenza virus infected mice showed increased survival after lethal infection, we next questioned whether the amount of influenza virus was reduced in the lung. therefore, we performed quantitative real-time (qrt) pcr to detect viral mrna. mice were treated with either sc or the solvent, and hour later the lungs were prepared to perform qrt-pcr. as shown in figure a the amount of viral mrna was reduced by % in sc treated mice compared to solvent treated controls, indicating that sc leads to a reduced expression of h n specific mrna in the lung of infected mice. since infection of mice with h n leads to hypercytekinemia, we also investigated the expression of cytokines in sc treated mice. as shown in figure b the amount of il- specific mrna was drastically reduced in sc treated mice compared to solvent treated controls. moreover, also the expression of ip- was altered in sc treated h n influenza virus infected mice. here, roughly % reduction of specific mrna was detectable ( figure c ). thus, sc leads to a reduced transcription of il- and ip- in h n infected mice. there is an urgent need for new concepts to develop antiviral drugs against influenza virus. targeting cellular factors is a promising but challenging approach, and the concerns about side effects are obvious. however, it should be considered that drugs targeting viral factors, such as amantadine or oseltamivir, also exhibit a wide range of side effects in patients. thus, drug safety has to be rigorously tested in clinical trials regardless whether a drug targets a cellular or a viral factor. moreover, resistance against human h n influenza viruses and highly pathogenic avian h n virus strains to oseltamivir and amantadine have been reported. in that respect, the strategy to target cellular factors , might be one way to ensure that new drugs against influenza virus will be useful and effective for a long time without causing the development of resistant virus variants. we were able to demonstrate that the nfkappab inhibitor sc is able to reduce influenza virus activity in cell culture. moreover, the compound was also effective against highly pathogenic avian influenza viruses of the h n and h n subtypes in the mouse model. next to the reduction of virus sc was also able to reduce h n -induced overproduction of cytokines and chemokines in the lung in the lung of mice after infection with h n . most importantly, the drug did not show any tendency to induce resistant virus variants (data not shown). thus, a sc based drug may serve as a broadly active non-toxic antiinfluenza agent. [ ] [ ] [ ] [ ] [ ] in hong kong, the first confirmed case was a tourist from mexico reported on may , . the local government made its first attempt to contain the spread of h n in the local community by closing the metropark hotel where that tourist was staying, and quarantining guests and staff for days. following identification of the first local case around weeks later on june , , the government closed all kindergartens and primary schools from june until early july. fever clinics were also opened, the alarm levels in hospitals were raised to the highest, and a public education campaign was implemented. previous studies of the community responses to severe acute respiratory syndrome (sars) and human-to-human h n avian flu identified the importance of understanding the background perceptions of risk and psychological impact on the community. [ ] [ ] [ ] [ ] [ ] in this study we investigated the psychological and behavioral responses of the general local community throughout the first wave of ph n , and we also examined the factors associated with greater use of preventive measures. a total of surveys were conducted between april and november , covering the entire first wave of the ph n pandemic. computer generated random-household telephone numbers from all land-based local telephone numbers covering over % of hong kong households were used to recruit a total of local adults. one cantonese-speaking adult (age ‡ ) was invited for interview in each selected household on the basis of a kish grid. the survey instrument was based on previous experience in sars and avian influenza projects. information, including knowledge on modes of transmission, psychological responses to pandemic influenza, preventive behaviors, attitudes towards the new vaccines and socio-demographics, was collected. informed consent was obtained prior to the interview. ethics approval was obtained from the institutional review board of the university of hong kong. descriptive statistics were weighted by sex and age based on the reference population data provided by the hong kong government census and statistics department. multivariable logistic regression analyses were used to examine the association between the use of preventive measures and knowledge, perceptions and behaviors, sociodemographic characteristics, and psychological responses to pandemic influenza. multiple imputation was used to cope with a small proportion of missing data and make the best use of all available data. statistical analyses were conducted in r version . . (r development core team, vienna, austria). twelve thousand and nine hundred and sixty-five local adults were recruited throughout the study period, with a total of telephone calls being made; the response rate among eligible participants was . %. hong kong entered the containment phase after the world health organization (who) announced a global alert, and policies including border screening, tracing, and quarantine of doi: . /j. - . . .x www.influenzajournal.com suspected cases were implemented. hong kong transitioned to the mitigation phase on june , when the first local case was reported. the chronology of these and other events plus the epidemic curve of laboratory-confirmed ph n cases are shown in figure (a) . the anxiety scores and risk perception of the respondents are shown in figure (b,c) . anxiety, measured by the state trait anxiety inventory, remained steady throughout the study period. in response to the announcement made by who and the unknown nature of the new virus, a higher proportion of the respondents expressed worry (more, much more, or extremely more worried than normal) if developed ili and perceived ph n severity (same, more, or much more serious than sars) initially in early may . fewer respondents reported worry if they developed ili as the pandemic proceeded, with a slight perturbation around the first deaths in july and a steady decline to . %, while perceived severity of ph n declined more dramatically after an early high. perceived risks of infection of respondents (absolute susceptibility) and risk relative to others (relative susceptibility) were also investigated and found to remain relatively stable throughout the first wave, with no indication of an increase during the period of peak ph n activity in september (figure c) . as the first wave of ph n progressed, knowledge on modes of transmission did not improve. on the contrary, later in the epidemic increasing proportions of respondents reported oral-fecal and cold weather as modes of transmission of ph n . around - % of the respondents did not recognize direct and indirect contact or touching infected persons and contaminated objects as transmission routes for ph n throughout the first wave ( figure d ). higher proportions of respondents avoided crowded places and rescheduled travel plans in the second half of june when local kindergartens and primary schools were closed and the first ph n -associated deaths were announced. social distancing measures such as avoiding crowded places and rescheduling travel plans remained stable with slightly decreasing trends thereafter. the use of hygiene measures and other social distancing strategies was relatively stable with slightly decreasing trends during the study period ( figure ). female sex and older age were generally associated with greater reported use of hand hygiene measures, home disinfection, avoidance of crowded places, and rescheduling of travel plans. female sex was also positively correlated with use of face masks and cough etiquette. we found a negative correlation between anxiety and use of all hand hygiene measures and cough etiquette, but a positive correlation between anxiety and use of home disinfection and (c) proportion of the respondents reporting higher worry if developed flu-like symptoms (more, much more, or extremely worried), higher perceived seriousness of h n compared to sars (much more or more severe), higher probability to contract h n over the next month (certain, much more, or more likely), higher probability to contract h n over the next month compared to others outside family (certain, much more, or more likely). (d) proportion of the respondents identifying possible modes of transmission as the actual modes of transmission of h n . social distancing measures. other significant factors contributing to greater use of preventive measures were worry and knowledge. greater worry was associated with higher probability of home disinfection, social distancing measures, and use of face masks. knowledge that h n could be spread by indirect contact was associated all the investigated preventive measures, and knowledge that h n could be spread by droplets was associated with cough etiquette, but not face masks. there were no consistent trends between all the investigated preventive measures and absolute and relative susceptibility. community transmission emerged in hong kong in mid-june , and prior to emergence of community transmission, perceived risk and perceived severity were high. as ph n spread in hong kong, risk perception declined, even at the same time as incidence was increasing. anxiety was low throughout, at around . on the -point scale, compared to a maximum of . during sars on the same scale. anxiety has been showed to be positively correlated to personal hygiene measures and social distancing in previous studies; , however, we found a negative correlation between anxiety and use of all hand hygiene measures, cough etiquette, and face masks, and a positive correlation between anxiety and home disinfection. the differences in findings may be due to the fact that our anxiety measure was not specific to h n , and the score could be affected by other factors including economics. unlike hygiene measures, higher anxiety level, greater worry, and higher risk of perception were all associated with more social distancing. , , , social distancing is the most direct strategy in avoiding infection from other people, and it is commonly observed in an outbreak that the general public avoids crowded places, travelling to other countries, and social gatherings, , but the economic impact could be substantial. as community incidence of h n peaked, we did not observe any increase in use of preventive measures (figure ) . we found that face mask use peaked at the early stage of the pandemic, while hand hygiene remained fairly constant, and the knowledge on the modes of transmission of ph n did not improve over time. the lack of substantial change in preventive measures or knowledge about the modes of ph n transmission in the general population suggests that community mitigation measures played little role in mitigating the impact of ph n in hong kong. on the other hand, knowledge that ph n could be spread by indirect contact was associated with all of the preventive measures studied. consistent with reports during the sars period, , this study also showed that females and those of older age were more likely than others to use hygiene measures, avoid crowded places, and reschedule travel plans. this study has some limitations. first, this was a crosssectional study that was carried out at different time points, rather than a longitudinal study following the same individuals over time, and so the inferences on changes in behavior may need to be interpreted more cautiously. second, we recruited samples from all land-based local telephone numbers that cover % of hong kong households, but the response rate was not high enough to guarantee a representative sample, and this could be a source of selection bias. third, the responses were self-reported, and this may lead to social desirability bias in estimating knowledge, attitudes, and preventive behaviors. fourth, since the hong kong population has previously gone through unique experiences from sars in and avian flu in , our results may not be comparable to other countries or settings. in conclusion, this study revealed that the ph n pandemic failed to generate an increase use of preventive measures in the local community. there was no association between anxiety level and the events of the pandemic. with a relatively low mortality and morbidity rates compared to sars, ph n was not a matter of concern in the hong kong community. the lack of substantial change in the use of preventive measures and improvement in knowledge on the modes of transmission of ph n suggested that public health campaigns during the pandemic may not have had substantial effects on the general public. london is a major tourist destination, the seat of government and finance in the uk, and in will host much of the olympic and paralympic games. along with the rest of the global community, in and early london faced the challenges of responding to the first pandemic of the st century. at the time, nhs in london was composed of organisations, including the london ambulance service, acute hospitals, mental health and primary care trusts, and the strategic health authority. while london's nhs is well practiced at responding to large, big bang incidents, the influenza a ⁄ h n v pandemic was a rising tide event that lasted many months. significant preparatory work had been undertaken prior to april , which meant that the nhs in london was ready to respond. nhs london (the strategic health authority for london) led the response in partnership with local managers in all nhs organisations. the first uk cases of influenza a ⁄ h n v were reported in scotland on april, with the first in london on april. cases continued to increase, and the first wave peaked in london in july. cases reduced over the school summer holidays, but increased again when children returned to school at the start of september, and a second, smaller wave occurred. it is essential that the nhs learns from the ⁄ influenza a ⁄ h n v pandemic to ensure it is prepared for future challenges. nhs london provided a standardised debriefing pack to all nhs organisations in the region to identify, capture, and learn lessons. each debrief event involved health and inter-agency partners to ensure all viewpoints were considered and brought together in a single local report. all local reports were compiled in an over-arching document, which brings together common themes to inform ongoing preparedness in the region. the debrief process identified a number of common themes, such as the need for clear and appropriate communication, the importance of working with partners, and the benefits of strong and early leadership. however, differences between and within organisations were also highlighted; for example, some wanted more freedom for local decision making, whereas others would have preferred more stringently applied central direction. the following paragraphs considers individual areas assessed in the debrief process. command and control was in the main effective, with clear direction delivered from the national centre through nhs london to local nhs organisations. effective leadership is essential; the identification of senior local individuals to lead the response with teams of people to support them was critical. appropriate use of technology to communicate messages and coordinate command and control processes greatly aided the response. this included the development of the nhs london noon brief, a daily digest and associated web portal, and regular teleconferencing. key points are: • operational management at all levels must be considered in pandemic planning. • appointing an executive lead in each organisation was invaluable in the response. • pandemic flu planning for london must continue to be regionally led. communication is an essential component of the response to any incident. it must be clear, timely, and accurate. in the main, communication was excellent and met these criteria. one of the most challenging aspects was when messages from partner organisations differed, which occasionally led to confusion, unnecessary work, or frustration. the use of technology greatly aided communication across the region and supported the response; this included secure web sites, bluetooth, and text messaging etc. key points are: • regular internal communications and staff briefings are critical in the response to emergencies. • regular teleconferencing should be incorporated into future plans. • organisations should consider proactive and innovative methods for communicating during emergencies. robust partnership working was an essential component of pandemic preparedness work; however in the event, the a ⁄ h n v pandemic had little impact on sectors in london other than health. resilient communication networks between organisations, a common understanding, and the ability to make decisions were essential to the response at local level. ipcs proved an excellent mechanism to maintain local working relationships and resolve problems. clarity on the seniority of those attending these meetings and whether multi-site organisations such as mental health trusts should attend every ipc should be considered on a local and regional basis. key points are: • pandemic planning must remain part of inter-agency working. • social care resilience and planning must be embedded and integrated in health planning. 'vulnerable groups' is a universal term that covers a large and fluid group of individuals with different needs. ensuring access to healthcare during the pandemic for those who became vulnerable due to the situation, or those identified as such prior to the event, was the role of the pct in partnership with the local authorities. work continues to ensure that communication with vulnerable people is appropriate and timely in all incidents, and that organisations work together to achieve this. key points are: • planning to support the breadth of vulnerable people must continue. • pandemic preparedness for the prison sector should be further developed. • red ⁄ amber ⁄ green ratings for assessing vulnerabilities of mental health service users in an emergency should be further developed across the region. correct and appropriate usage of ppe is an essential component of reducing influenza spread, particularly in healthcare settings. london's nhs had been working towards developing local stockpiles of ppe when the pandemic commenced; however, there was little in place. the unanticipated national stockpile, while providing ppe to all organisations, was accompanied with some challenges in that it was often unfamiliar stock. key points are: • work around local stockpiling of non-standard consumables should continue. • regular training and fit testing of respirators should be embedded in all organisations. antiviral treatment was a core component of the response to influenza a ⁄ h n v, and was provided free of charge from a national stockpile. npfs reduced pressure on frontline nhs services once it was activated; however, there were concerns that patients could 'cheat' the system and obtain the drugs prior their clinical need. information about storage requirements of countermeasures must be clearly explained when they are delivered to frontline services, and the potential for recall into national stockpiles should be planned for. key points are: • regular exercising of local mass countermeasures centres and antiviral collection points (acps) should continue. • the use of community pharmacies as acps should be further considered in the capital. pandemic influenza vaccine uptake by healthcare workers was better than usual seasonal influenza uptake in the majority of nhs organisations, but could have been even better. this was largely due to the second pandemic wave not being as significant as expected, lack of clarity around when the vaccine would be delivered, and limited amounts being available initially. • gp-led and mass vaccination models for pandemic vaccination should be considered in local plans. • local lessons from the pandemic vaccination campaign should be applied to seasonal flu vaccination. the ability to maintain or increase capacity in response to a surge in demand, no matter what the cause, must be planned for. any of a number of situations could result in reduced staff or more patients, such as industrial action, transport disruption, disease outbreak, major incident, or poor weather. the work undertaken during planning for and responding to the pandemic will stand organisations in good stead for future disruptions. the importance of robust business continuity planning locally cannot be overlooked, as this is a key component of maintaining and increasing capacity. key points are: • local gp 'buddy schemes' should be encouraged for response to extreme pressure events. • organisations should regularly run staff skills audits so as to be aware of their overall capability for managing emergencies. • less emphasis should be placed on the use of retired staff when planning service continuity. reporting is a necessary but onerous task, and is often one of the most time-demanding parts of any incident response. it is also the aspect least likely to be tested through exercising. nhs london worked with organisations to endeavour to reduce reporting pressures, but much of this was dictated by central government. it is essential that future reporting requirements are proportional, informative, and realistic. while recognising it is not possible to predict the detail of information that may be requested, some broad assumptions can be made. key points are: • organisations should consider how they would collect and collate data from disparate parts of their organisation, rather than focussing on the detail of what that might be. • national and regional planning should consider the need for information and how this is balanced with the demand this places on organisations. • the introduction of the concept of a daily dashboard to identify areas of pressure should be incorporated into pandemic flu planning. the winter and pandemic influenza resilience assurance process undertaken in autumn was a useful process to inform planning for the first winter when the pandemic virus would be circulating in the uk. this consisted of a regional inter-agency exercise and a comprehensive review of the winter and pandemic plans of all nhs organisations in london. • regular assurance of pandemic flu preparedness should be maintained. • future resilience assurance processes should be undertaken in a timely and measured manner. • local organisations should continue to undertake regular pandemic flu exercises. the recovery period is as important as the response, but often receives minimal attention and has the potential to suffer as staff return to their normal jobs. one of the aspects that was not anticipated during the pandemic was the amount of stock (ppe, antivirals, and vaccine consumables) that would be recalled into national stockpiles. this proved particularly challenging for pcts who had to coordinate the process across their local areas. key points are: • the recovery period of an emergency must be given the same status and importance as the response. • future pandemic flu planning must include the recovery of national stockpiles of equipment and medicines. it is essential the lessons from the ⁄ influenza a ⁄ h n v pandemic are learnt and embedded into business-as-usual and emergency response processes in preparation for the next pandemic and other incidents. even though the a ⁄ h n v pandemic was generally milder than previous pandemics, it still presented challenges to the nhs in london. the biggest challenge that remains is to ensure that the public and nhs staff are aware that a more virulent virus could cause significantly more illness, death, and disruption, and that we must maintain our preparedness should this happen. the influenza a ⁄ h n v pandemic has been a major stimulus to business continuity planning and emergency preparedness across health in london, and many of the experiences during the pandemic proved invaluable in the unusually severe weather in early . it is important that this impetus and focus is maintained. changes to the nhs landscape in london will be considered in ongoing pandemic and emergency preparedness to ensure we remain as well prepared as possible for future events, particularly as london approaches the olympic and paralympic games. one of the major lessons learnt from all global pandemic events is that better preparedness of national health systems to deal with influenza viruses could make a significant difference. the way national health systems operate during inter-pandemic and the pandemic alert periods and the methods they use to address potential threats posed by zoonotic viruses with pandemic potential, as well as sea-sonal influenza epidemics, can clearly indicate whether the countries have enough capacities to respond adequately to unexpected influenza outbreaks. these public health decisions to ensure the maximum of efficiency require a robust scientific knowledge base. the who public health research agenda for influenza developed by the global influenza programme (gip) in cooperation with international influenza experts identified specific research topics and their importance in meeting stream-specific breakout discussion groups during the global consultation meeting included representatives of researchers and public health professionals. funding organizations were invited to observe the process with no direct participation in the deliberations. the methods used to design the research roadmap for an influenza pandemic scenario are closely related to the process of development of the final document of who public health research agenda for influenza. during a pandemic scenario, the group prioritized topics and questions relating to rapid action and response. five to key public health needs associated with a pandemic scenario have been identified for each of the research agenda streams: five priority public health topics were identified for a pandemic scenario as follows: • examination of host range and transmission dynamics of animal influenza viruses to guide surveillance, control strategies, and risk communication. • enhanced surveillance in animals and humans to monitor virus evolution: o early detection of novel reassortants or changes in genotype and ⁄ or phenotype related to virulence. o development of epidemiological and laboratory diagnostic tools and capacity building to optimize case finding. o develop a framework for surveillance in animals that address ethical, legal, and social barriers to intra-pandemic surveillance and reporting. • deconstruct the origins of the pandemic virus to identify factors that permitted efficient human transmission. • develop strategies to limit economic, social, and cultural disincentives of animal-based interventions to reduce intra-and inter-species transmission. • operational research to optimize risk communication in the early phases of the pandemic linked to animal husbandry and food safety. stream : limiting the spread of pandemic, zoonotic and seasonal epidemic influenza ten priority research topics were identified for both pandemic and inter-pandemic scenario as follows: transmissibility of influenza across the progression of infection and spectrum of disease: • relative contributions of the different modes of transmission for influenza. five priority public health topics were identified for a pandemic scenario as follows: • identification of groups at higher risk of infection and severe disease outcome through enhanced surveillance. • understanding disease severity and identification of predictors of severe outcomes. • investigation of vaccine effectiveness, especially in high risk groups in diverse geographic areas. • establishment ⁄ enhancement of pharmacovigilance, particularly for adverse events among at-risk groups. • optimization of strategies for rapid and targeted vaccine deployment. • rapid assessment to optimize acceptance of pandemic vaccine. six priority public health topics were identified for a pandemic scenario as follows: • collaboration and coordinated sharing of data, protocols, regulatory, and other implementation strategies and databases from different countries on all aspects of patient management and outcome to accelerate improvements in patient care. • development of best practices in patient management in different settings, including checklists and algorithms for clinical care and treatment, prognostic parameters, and tests to predict potential for the development of severe disease. • rapid, reliable, simple, low-cost point-of-care diagnostic tools for influenza. • best use of current antiviral drugs and optimal formulations in different target populations, such as parenteral and other routes of administration for severe infections. • use of combination therapies, including use of adjunctive therapies (e.g., use of convalescent serum and immunomodulators). • role of ongoing viral replication, host responses, and the effect of co-infections in the pathogenesis of severe disease. modern tools for early detection and monitoring of disease the group on surveillance tools concluded that the agreed topics of interest were equally applicable during a pandemic or inter-pandemic period: • studies to appraise and adapt modern technologies for early detection of influenza outbreaks in surveillance at the human-animal interface. • develop, integrate, and evaluate innovative approaches for influenza surveillance and monitoring with other existing disease monitoring systems. • study efficient mechanisms on sharing data, clinical specimens, and viruses with consideration for local, ethical, legal, and research perspectives. • examine the timeliness and quality of data required for early detection from local to national and global levels for the respective stakeholders. five priority public health topics were identified for a pandemic scenario as follows: • identify environmental determinants of seasonal variation in influenza transmissibility in tropical and temperate regions. • estimate the transmission risk associated with types of contacts by comparing measured contact patterns with outbreak data. • incorporation of validated models of behavioral responses to risk and control measures in virus transmission. • development and implementation of novel technology for real-time sero-surveillance during a pandemic. • develop experimental and theoretical framework to assess host adaptation to study host receptor, antigenicity, and virulence. modern tools for strategic communication three priority public health topics were identified for a pandemic scenario as follows: • evaluate tools to more rapidly and accurately assess and monitor knowledge, attitudes, beliefs, and practices in different population groups to guide future communication efforts; develop tools and methods to more rapidly and accurately assess and monitor knowledge, attitudes, beliefs, and practices in different population groups, and thereby, guide future communication efforts. for communicating in different cultural settings, which engage and empower individuals and communities to practice and promote appropriate risk reduction measures. implementation of the identified research priorities is expected to underpin public health decision making at all levels with proven knowledge that will help to save large numbers of lives, reduce health costs and economic loss, and mitigate potential social disruption. complemented by an analogous research roadmap for a pandemic influenza scenario, the research recommendations for an interpandemic period represent a framework to provide evidence to guide public health policies on influenza control. one of the major lessons learnt from all global pandemic events is that better preparedness of national health systems to deal with influenza viruses could make a significant difference. these public health decisions to ensure the maximum of efficiency require a robust scientific knowledge base. the who public health research agenda for influenza developed by the global influenza programme (gip) in cooperation with international influenza experts identified specific research topics and their importance in meeting public health needs for inter-pandemic periods according to its five key research streams: • stream . reducing the risk of emergence of pandemic influenza. • stream . limiting the spread of pandemic, zoonotic, and seasonal epidemic influenza. • stream . minimizing the impact of pandemic, zoonotic, and seasonal epidemic influenza. • stream . optimizing the treatment of patients. • stream . promoting the development and application of modern public health tools. stream-specific breakout discussion groups during the global consultation meeting included representatives of researchers and public health professionals. funding organizations were invited to observe the process with no direct participation in the deliberations. the methods used to design the research roadmap for an influenza inter-pandemic scenario are closely related to the process of development of the final document of who public health research agenda for influenza. during an inter-pandemic phase, a more comprehensive approach was applied to establish research topics and prioritizing a range of questions that will build a solid foundation to guide research activities to support public health decision making. five to ten key public health needs associated with an inter-pandemic scenario have been identified for each of the research agenda streams: stream : limiting the spread of pandemic, zoonotic, and seasonal epidemic influenza ten priority research topics were identified for both pandemic and inter-pandemic scenario as follows: . transmissibility of influenza across the progression of infection and spectrum of disease . relative contributions of the different modes of transmission for influenza . biological, behavioral, and social host factors that influence the risk of transmission and infection . patterns, drivers, and mechanisms affecting the seasonality of transmission . viral and population factors that influence transmission and spread of different influenza types, subtypes, and strains . strategies to reduce the transmission of influenza in community, household, and health care settings, especially in less-resourced areas . impact and cost effectiveness of social measures, such as school closures, and the role of surveillance in assessing timing of these interventions . impact, effectiveness, and cost effectiveness of individual measures, such as isolation and quarantine . role of vaccination in limiting the spread of influenza and strategies for its use . impact of antiviral treatment and prophylaxis in reducing transmission of influenza stream : minimizing the impact of pandemic, zoonotic, and seasonal epidemic influenza . identify higher risk groups and severe disease through surveillance; disease severity and identification of predictors of severe outcomes . evaluate vaccination preventable disease burden and the potential impact of immunization programs through vaccine demonstration projects . enhancement of the properties of existing vaccines, including duration and breadth of protection, safety, immunogenicity, and dosesparing . development of new vaccines and vaccine platforms, especially suitable for under-resourced country settings . study the effectiveness of vaccine strategies to reduce disease burden in children and other high risk groups in a wide range of settings . improved uptake and acceptability of vaccines for both seasonal and pandemic influenza seven priority public health topics were identified for an inter-pandemic seasonal influenza scenario as follows: inter-pandemic seasonal influenza scenario . research on the burden of severe disease with a focus on regionalspecific factors, such as the burden of tb and hiv and optimization of pandemic and management . development of new antiviral strategies and validation of surrogate endpoints which may aid in advancing understanding of disease progression . further clinical evaluation of current antiviral drugs, particularly in populations at risk . integration of seasonal influenza with pandemic preparedness; strengthen surveillance, health care systems, capacity, and preparedness planning . improving diagnostics (e.g., multiplex assays for viruses and bacteria), including antiviral resistance testing at point-of-care . dissemination of best practices, situation analysis, preparation for next epidemic (e.g., establish protocols for rotating stockpiles of antiviral drugs) . increased attention to basic science research such as studying immunomodulatory drugs five priority public health topics were identified for an inter-pandemic zoonotic influenza scenario as follows: inter-pandemic zoonotic influenza . antiviral susceptibility of circulating zoonotic viruses (e.g., h , h , h influenza viruses) . reassortment between zoonotic and human influenza viruses and the potential for inter sub-type spread of antiviral resistance and virulence modern tools for early detection and monitoring of disease the group focusing on surveillance tools concluded that the agreed topics of interest were equally applicable during both pandemic and inter-pandemic period: . identify modern technologies for early detection of influenza outbreaks as well as their application in surveillance at the human-animal interface . develop and evaluate innovative approaches for influenza surveillance and monitoring with other existing disease monitoring systems . studies to address challenges on data, clinical specimens, and viruses sharing with consideration for local, ethical, legal, and research perspectives . examine the timeliness and quality of data required for early detection from local to regional, national, and global levels role of modeling in public health decision making five priority public health topics were identified for an inter-pandemic seasonal influenza scenario as follows: . integration of genetic and epidemiological data to understand spatiotemporal spread to forecasts evolution for vaccine strain selection and to anticipate likely burden of disease . quantifying the relative contributions of different modes of transmission of human influenza and developing mechanistic modeling of transmission processes . research using data-capture technologies to characterize human contact and mobility patterns at local, regional, and global scales, and their correlation with transmission risk . integration of genetic, antigenic, and epidemiological analyses to optimize surveillance for newly emerging pathogens at the animal ⁄ human interface . identifying and quantifying human and environmental ecological, behavioral, and demographic determinants of the risk of cross-species transmission and pandemic emergence modern tools for strategic communication four priority public health topics were identified for an inter-pandemic seasonal influenza scenario as follows: . review of evidence and experience related to health crisis communication from fields to organize knowledge and support evidencebased practice in strategic communication . identify and develop tools to rapidly and accurately monitor knowledge, attitudes, and practices in different population groups and guide future communication efforts . identify and develop communication tools and approaches for cultural settings and communities to practice and promote appropriate risk reduction measures . understand the potential ethical, social, economic, and political communication in crisis and develop strategies to work within constraints while maximizing opportunities complemented by an analogous research roadmap for a pandemic influenza scenario, the research topic recommendations for an inter-pandemic period represent an important outcome of joint international efforts by who, academicians, and public health experts. implementation of the identified research priorities is expected to underpin public health decision-making at all levels with proven knowledge that will help to save large numbers of lives, reduce health costs, and economic loss and mitigate potential social disruption over a medium-tolong term period. the impacts of school resumption on the incidence of pandemic (h n ) in school students introduction school closure is one non-pharmaceutical intervention that is often suggested in pandemic preparedness plans, and it was widely implemented in pandemic (h n ) to reduce transmission amongst school students. however, from past epidemiological studies, the effect of school closure in reducing respiratory disease transmission was inconclusive. given this public health intervention causes major disruption to the education system and potentially raises childcare issues to working parents, evaluating its effect in the recent pandemic is necessary to improve future pandemic planning. in hong kong, since school closure was implemented early in the pandemic and closure was effectively continued with the commencement of summer holiday, the lack of incidence data in the absence of school closure makes it difficult to analyse its effect directly. this has prompted us to analyse the situation indirectly from the angle of school resumption after summer holiday. in hong kong, public health surveillance on pandemic (h n ) was effective from th april- th september : healthcare professionals were advised to report suspected cases of infection to centre for health protection, department of health, hksar, for further laboratorial confirmation. demographics of reported cases were subsequently recorded into a computerised system (the ''e-flu'' database). following institutional approval, a dataset of all confirmed cases diagnosed from may to september was obtained, which included the age, gender, confirmation date, and notification date of each report. all cases were classified into four defined socio-economic classes by age: pre-schoolers ( - ), school students ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , adults ( - ), and retirees ( ‡ ). assuming cases had contracted infection on the earlier date between confirmation and notification, daily incidence in each age class was counted for epidemic curve construction. upon observing an unusual rise in the epidemic curve of school students when school season resumed in september, interrupted time series analysis (also known as intervention analysis) was applied to obtain the statistical significance of this observation. the analysis was applied to the incidence in school students from th july to th september , which covered the period from the start of summer holiday to the end of the th week of new school season. incidence in school students before summer holiday was deliberately dropped since not all schools were closed when the school closure policy was effective: all primary schools were closed proactively, whereas secondary schools were individually closed on a reactive basis if students were identified to have contracted the infection. school activity was formulated as a step function, which takes value from st september onwards (st = : t < st september, st = otherwise). a range of times series models were fitted by the maximum likelihood method and aic (akakine information criterion) was used to select the one with best fit. all computations were performed in sas version . . a total of ( ae %) pre-schoolers, ( ae %) school students, ( ae %) adults, and ( ae %) retirees were diagnosed with the infection in the surveillance period. the epidemic curves of preschoolers, school students, and adults showed a steady rise from th june onwards when local transmission of pandemic influenza was identified. an upsurge in the epidemic curve of school students can be observed in early september, coinciding with the commencement of the new school year (figure ) . interrupted time series analysis on the epidemic curve of school students returned an arima( , , ) model with equations: where st, yt, yt denote school activity, predicted and actual incidence in school students on day t, respectively. standard error and significance for model constants were: ae (se = ae , p = ae ), ae (se = ae , p = ae ). in short, the model can be interpreted as: the number of infected school students rose by ae per day on average during the entire study period, with a sharp increase by ae coming into effect when the new school year began. time series analysis showed, at the marginally significance level, that daily incidence in school students had a major increase when school season resumed. on the assumption that the increase was not caused by any change in health seeking behaviour, this result suggests that school resumption had facilitated transmission amongst school students. on the basis that school activity significantly increases incidence of pandemic influenza in school students, this study suggests closures of schools in the early phase of pandemic (h n ) and subsequently in the summer holiday probably had a major effect in mitigating transmission amongst school students. youngsters were postulated to be major vector for transmission in pandemic (h n ) . if this were true, it would be reasonable to expect the epidemic curves of the other age classes to show a similar upsurge when one is observed in school students. the absence of such observation in the epidemic curve of hong kong suggests school students were mostly disseminating the virus amongst themselves, but not to the other age groups. in november , gip convened the first global consultation on a public health research agenda for influenza to identify key research topics in each of the five main streams of public health research. during this meeting, the scientific working group (swg) of the sub-stream in ''modern tools for risk communication'' identified the requirements in research during influenza pandemics and inter-pandemic periods to provide clear, credible, and appropriate messages which meet the needs of diverse communities. the swg suggested that who hold a follow-up workshop to assess the use of modern tools related to strategic and risk communication and to further promote research in these areas. communication'' in may . one of the main objectives of the meeting was to generate a roadmap of public health research priorities related to strategic and risk communication. the research roadmap was developed by the group of invited experts on the basis of an analysis of available evidence and experience on public health and health crisis communication from relevant disciplines across global regions, as well as critical assessment of existing communication methods related to influenza control in different cultural, social, and ethnic settings. the workshop consisted of a series of presentations by experts in relation to experiences and lessons learned about communication during the sars, h n epidemic, and h n pandemic. there were also a series of group discussions on identifying research needs for pandemic and interpandemic periods in order to strengthen the research agenda. the expert group identified important public health needs in relation to communication during pandemics as well as in the inter-pandemic times. the main topics of discussion centered on communicating issues of influenza virus transmission, the use of influenza vaccines safety and efficacy, and use of antivirals as well as definition of the severity of the pandemic and the phase changes. in this context a number of research areas were identified, which can be broadly classified into four areas: understanding of communication principles and mechanisms is associated with an array of research topics covering different subject areas. one of the key questions here relates to the link between communication and ''behaviour change'' models and their application and appropriateness for different settings. the expert group defined the term ''behaviour change'' in this context as the modification of behaviour towards better health practices that are supported by clinical and scientific evidence for personal protection against infectious diseases and other adverse health risks. research topics related to these models require understanding and differentiating information and ''behaviour change'' needs of different audience segments, such as stakeholder mapping, target audience analysis, research into behaviour motivation, social norms, and the cultural, religious, social, legal, and political barriers and enablers of particular behaviors that are beneficial in influenza control. this research area also includes the analysis of media consumption among different audiences, role models, including ways to analyse how rumours and misinformation are spread, and ways to provide evidence-based information correctly. other important areas of investigation embrace methods to communicate uncertainty, learning how to build trust while communicating about a pandemic, and understanding what needs to be done before, during, and after a pandemic in order to create the best environment for influenza pandemic communication. critical key audiences identified for more intensive analysis were health workers, religious, public health, and societal (political and community) leaders. • investigation of the role of different communication channels and communication formats for different target audiences in a pandemic, particularly for groups that are ''hard-to-reach.'' • determining effects of perceptions related to pandemic influenza (severity, susceptibility, response efficacy, self efficacy, perceived social norms) on protective behaviours in different groups. • understanding audience in terms of their knowledge, preventive activities, and reasons why engaged ⁄ not engaged. • developing mechanisms to synergies between risk communication and behavior oriented approaches in the pandemic and inter-pandemic phases. • determining social, economic, cultural, and religious factors which support behaviours to limit spread and minimize impact in different settings. • identification of the key predictors ⁄ factors that influence people's behavior among different groups and populations vis-à -vis pandemic flu behaviors. • identification of elements that contribute to trust among populations and in different settings (country, public, professional, community), particularly where trust was previously compromised. • understanding psychology of different groups regarding their response to uncertainty, and finding the best way to communicate uncertainty. the research questions in this section relate to the planning, development, and evaluation of tools that can be quickly accessed and used in a pandemic situation. these may include communication materials and channels; the setting up of key stakeholder and champion communication networks; research protocols that are ready for rapid assessment during a pandemic or new communication tools. the use and understanding of terminology and language by both lay and professional groups and communities in planning for and ⁄ or reacting to a pandemic are important areas of research. acute examples, such as the naming of the viruses or the use of the word ''pandemic,'' illustrate this need well. the research focus of this area is to look at lessons learned from the a(h n ) pandemic and to document and evaluate case studies, both looking at best practices, challenges, and barriers that were experienced. different communication strategies need to be evaluated and models to be built not only in terms of reach, but also in terms of impact on thinking, emotional response, and behavioural modification. a key question was how to prepare communication for a pandemic and how can the pandemic communication contribute to longer term ''behavioural change.'' mathematical modelling on gauging outcomes of such ''behaviour change'' would provide strategic approaches in risk communication. this section aims to answer the question whether the modeling, mapping, and scenario planning are actually useful in the pandemic situation. the expert group agreed that the research on the above issues should use a variety of methods and engage a number of disciplines. this would include literature reviews, case studies, trials, ethnographic studies, modelling, surveys, network analysis, as well as any other useful methodology. in an inter-pandemic situation for actual behaviour under pandemic conditions. • study the synergies and develop priority research topics on strategic ⁄ risk communication for influenza under inter-pandemic situations that includes zoonotic and seasonal infections. the who public health research agenda for influenza initiated and facilitated a multi-disciplinary discussion for communication during pandemic and inter-pandemic situations. it focused on both theoretical and practical issues to improve practice and ensure the health of the public for influenza. critical areas for research were identified to build evidence in this field. it was recognized that there are extensive bodies of knowledge in a number of disciplines, , such as health promotion, behavioural psychology, social sciences, social and behaviour change communication, social marketing, and communication for development relating to these questions, and that these should be explored. outcomes of these research activities are expected to widen the evidence base which will support developing communication strategies for influenza by countries, institutions, and individuals and will, consequently, help to improve public health world-wide. abstract background: cytokine dysregulation contributes to the unusual severity of h n (reviewed in ). previously, we demonstrated that interferon regulatory factor (irf ) and p map kinase (p ) signaling pathways separately contribute to the induction of pro-inflammatory cytokines and chemokines in h n -infected cells. here we investigate the role of innate sensing receptors in the induction of these cytokines and chemokines in response to h n and seasonal h n infection. materials and methods: human macrophages derived from peripheral blood monocytes were infected with h n ( ⁄ ) or seasonal h n ( ⁄ ) viruses. the role of innate sensing receptors in cytokine and chemokine induction by h n virus was investigated using transient knock-down of these receptors with sirnas. the expression of innate sensing receptors in infected cells, and as a result of paracrine activation (by virus free supernatants of infected cells) of adjacent uninfected cells were also monitored by real-time pcr and ⁄ or western blotting. the involvement of janus kinase (jak) signaling pathways in these autocrine ⁄ paracrine cascades was investigated using a jak inhibitor. results: we previously showed that tnf-alpha, ifn-beta, and ifn-lambda are the key mediators directly induced by the h n virus in primary human macrophages with other cytokines and chemokines being induced as part of a secondary autocrine and paracrine cascade. here we demonstrated that retinoicacid-inducible gene i (rig-i) rather than toll-like receptor (tlr ) plays the predominant role in h n -induced cytokines and chemokines in human macrophages via the regulation of irf and nf-kb nuclear translocation. in addition to the effects on virus infected cells, paracrine interactions between macrophages and alveolar epithelial cells contributed to cytokine cascades via modulation of jak signaling and by the upregulation of sensing receptors. conclusions: h n directly induced tnf-alpha and ifnbeta mainly via rig-i signaling, and the subsequent activa-tion and nuclear translocation of irf and nf-kb in human macrophages. in addition to the effects on cytokine signaling, the innate immune sensing regulators themselves were also up-regulated by h n infection, much more so than by seasonal influenza infection, via jak signaling. the up-regulation of innate sensing receptors was not limited to the infected cells, but was also found in adjacent uninfected cells through paracrine feedback mechanisms. this may lead to broadened and amplified cytokine signals within the microenvironment of the infected lung. a more precise understanding of the signaling pathways triggered by h n virus leading to cytokine induction may provide novel options for the design of therapeutic strategies for severe human h n influenza and also for treating other causes of acute respiratory disease syndrome. human h n infection is associated with a mortality rate of more than %. the basis for the unusual severity of h n disease has not been fully explained. cytokine dysregulation has been suggested to contribute to the disease severity of h n (reviewed in ). however, signaling pathways involved in the cytokine induction by h n virus are not fully understood. previously, we demonstrated that irf and p map kinase (p ) are separate signaling pathways which contribute to the induction of pro-inflammatory cytokines and chemokines in h n -infected cells. rig-i and melanoma differentiation-associated gene (mda ) are important cytosolic sensors of nucleic acid of pathogens, while tlr and tlr also recognize nucleic acid species of pathogens, but they are localized at the endosomal membrane. rig-i was found to be responsible for the recognition of influenza a virus infection, and the transfection of vrnps induces ifn-beta expression. while many studies have shown the role of rig-i in the induction of ifn-beta by influenza virus infection, the majority of these studies used either immortalized cell lines or mouse embryonic fibroblasts. there is a lack of data on the role of these innate sensing receptors in highly pathogenic avian influenza h n infection in primary human cells in vitro, which are more physiologically relevant. furthermore, there is little data on the autocrine and paracrine up-regulation of these innate immune sensors following virus infection. human macrophages were obtained from peripheral blood monocytes by adhesion and differentiation in vitro for days in rpmi medium supplemented with % autologous plasma. the cells were infected with h n ( ⁄ ) or seasonal h n ( ⁄ ) viruses at a moi of ae . a cells were obtained from atcc and cultured in mem medium supplemented with % fcs and % penicillin and streptomycin. the role of innate sensing receptors in cytokine induction by h n and h n viruses was investigated using transient knock down of these receptors with sirnas in human macrophages as previously described using specific sirnas purchased from qiagen. immunofluorescence staining assay of irf and nf-jb was employed to detect the nuclear translocation of these transcription factors after h n infection. rabbit polyclonal antibodies against human irf and and nf-kb were obtained from santa cruz biotechnology. goat anti-rabbit igg antibody conjugated with alexa fluor was a product of molecular probes. for investigation of paracrine effects on rig-i and tlr expression, culture supernatants collected from mock, ⁄ or ⁄ infected human macrophages were used to treat uninfected cells. the supernatants were first passed through a filter with -kda cut-off. virus particles as well as molecules with a molecular weight higher than kda were retained and removed, while the filtrate was collected for treatment of uninfected cells. the expression of innate sensing receptors in infected cells and in adjacent uninfected cells following paracrine activation by virus free supernatants of infected cells was monitored by real-time pcr. the involvement of jak signaling pathways in these paracrine cascades was investigated using a jak inhibitor (calbiochem). we previously showed that tnf-alpha, ifn-beta, and ifnlambda are the key mediators directly induced by the h n virus in primary human macrophages with others being induced as part of a secondary autocrine and paracrine cascade. in this study, we demonstrate that knockdown of rig-i or tlr led to the reduction of ifn-beta and tnf-alpha in human macrophages by both ⁄ (h n ) and ⁄ (h n ) infection. as shown in figure a , ⁄ virus induced higher level of ifn-beta mrna expression than ⁄ infection. cells transfected with rig-i or tlr sirna significantly reduced the expression of ifn-beta after ⁄ infection, by % and %, respectively. rig-i silencing also significantly reduced the ifn-beta expression in ⁄ infected cells by %. in contrast, silencing of mda or tlr did not suppress the induction of ifn-beta by either ⁄ or ⁄ infection; in fact, there was a slight ( %) increase of ifn-beta in cells transfected with mda sirna. based on these results we conclude that while both rig-i and tlr contribute to h n -induced interferon-beta induction in human macrophages, rig-i plays the dominant role. in order to investigate the relationship between these innate sensing receptors and the activation of transcription factors irf and nf-jb, we next measured the nuclear translocation of irf and nf-jb in cells with rig-i or tlr silencing after h n infection. immunofluorescence staining assay on irf and nf-jb was performed and the number of cells with nuclear translocation was quantitated. the percentages of cells with nuclear translocation were plotted in figure b . we demonstrated that rig-i knockdown led to a significant reduction of irf nuclear translocation after ⁄ infection, whereas the nuclear translocation of nf-jb after ⁄ infection was significantly suppressed by rig-i or tlr silencing. these results suggest that the involvement of rig-i and tlr in the cytokine induction by ⁄ was via the regulation of irf and nf-jb nuclear translocation. since rig-i and tlr are important in influenza a virus-induced cytokine expression, we next explored the expression of these innate receptors in neighboring uninfected human macrophages by treating the uninfected macrophages with the filtered culture supernatants collected from mock, ⁄ , or ⁄ infected macrophages. as shown in figure a , ⁄ supernatant differentially induced the mrna expression of rig-i, mda , and tlr compared to ⁄ supernatant treated human macrophages. the induction of rig-i was higher than the induction of mda and tlr . in the presence of lm of jak inhibitor, the up-regulation of all three innate sensing receptors was significantly reduced showing their induction was dependent on jak activity. human lung epithelial a cells were also treated with the supernatants collected from macrophages infected with mock, ⁄ , or ⁄ virus. differential induction of rig-i, mda and tlr by ⁄ supernatant compared to ⁄ supernatant treated cells was observed (figure b) . ⁄ supernatant dramatically induced all three innate sensing receptors, while ⁄ supernatant only marginally induced rig-i and mda , but not tlr . as in human macrophages, treatment with lm of jak inhibitor caused a significant suppression of ⁄ supernatantinduced rig-i, mda , and tlr expression in a cells. these results, taken together with the direct effects on virus infected cells, suggest that paracrine interactions between macrophages and alveolar epithelial cells contributed to cytokine cascades via modulation of jak signaling and by the up-regulation of innate sensing receptors. h n directly induced ifn-beta ( figure ) and tnf-alpha (data not shown) mainly via rig-i signaling and the consequent activation and nuclear translocation of irf and nf-kb in human macrophages. these results were consistent with a previous study using beas- b cells showing the essential role of rig-i in ifn-beta reporter activity by h n influenza virus infection. while tlr also played a role in induction of ifn-beta and the activation of irf and nf-kb, it plays a less important role compared to rig-i. the reduction of irf and nf-kb activation was also confirmed with the study by le goffic showing differential regulation of irf and nf-kb by rig-i and nf-kb can also be regulated by tlr . in addition to the direct role of rig-i and tlr in sensing and signaling the presence of influenza virus, the innate immune sensing regulators were themselves also highly upregulated in both infected (data not shown) and adjacent uninfected cells by influenza virus infection. compared with seasonal h n virus, the h n viruses had a much more dramatic effect on inducing innate sensing receptors via jak signaling pathways activated by autocrine and paracrine mediators. the up-regulation of rig-i, mda , and tlr was markedly induced by virus free culture supernatants from h n -infected macrophages, while supernatant from ⁄ -infected cells induced the expression of these receptors only to a lesser degree. the soluble mediators in the virus infected cell supernatant caused paracrine upregulation of rig-i, mda , and tlr in uninfected macrophages as well as human lung epithelial cells. these effects may lead to broadened and amplified cytokine signals within the microenvironment of the infected lung. taken together these results provide, at least, part of the explanation on the hyper-induction of cytokines in h n infection. a more precise identification of the signaling pathways triggered by h n virus leading to cytokine induction may provide novel options for the design of therapeutic strategies for severe human h n influenza and also for treating other causes of acute respiratory disease syndrome. we generated mutants of y (h n ) and a ⁄ duck ⁄ hokkaido ⁄ vac generation and characterization of mutant viruses rgy sub (h n ), rgvac sub (h n ), and rgvac ins (h n ), which have a serial basic amino acid residues at their ha cleavage sites were generated by site-directedmutagenesis and reverse genetics. rgy sub (h n ) and rgvac ins (h n ) required trypsin to replicate in mdck cells, and showed similar levels of growth to their parental viruses (table ) . chickens intravenously inoculated with rgy sub (h n ) or rgvac ins (h n ) did not show any signs of disease. rgvac sub (h n ) replicated in mdck cells without exogenous trypsin, and one of the eight chickens inoculated with the virus showed slight depression at day post-infection. the h and h mutant viruses were serially passaged in the air sacs of chicks to assess their ability to acquire pathogenicity. plaque formation in mdck cells and pathogenicity in -day-old chicks and -week-old chickens are shown in table . rgy sub (h n ) replicated in mdck cells in the absence of trypsin and killed all of the chicks after six consecutive passages. two of the eight-four-weekold chickens inoculated intravenously with rgy sub-p (h n ) died within days. eventually, over % of the chickens intravenously infected with rgy sub-p (h n ) died by days post inoculation, and its pathogenicity was comparable to that of hpaivs. rgvac sub-p (h n ) was pathogenic to both chicks and -week-old chickens, and mortality increased after one more passage. rgvac ins-p (h n ) replicated in mdck cells in the absence of trypsin, killed all of the chicks, and caused % mortality among -week-old chickens. the lethal effect of rgvac ins-p (h n ) on chickens increased with one additional passage in the air sacs of chicks, as in the case of rgvac sub (h n ). to examine whether the pathogenicity of each virus via the natural route of infection correlated with that by intravenous infection or not, three -week-old chickens were challenged intranasally with the viruses at an eid of ae and observed for clinical signs until day post-infection (data not shown). all chickens inoculated with rgy sub-p (h n ) or its parental viruses survived without showing any clinical signs, and serum antibody responses were detected in the hi test. on the other hand, rgvac sub-p (h n ) and rgvac ins-p (h n ) were pathogenic as in the intravenous experiment, killing two of three chickens by day post-inoculation. one of three chickens were not infected with rgvac sub-p (h n ) or rgvac ins-p (h n ) via intranasal route (data not shown), indicating these p viruses had not been completely adapted to the host. to investigate the possibility of these p viruses to acquire further pathogenicity for chicken, rgvac sub-p (h n ) and rgvac ins-p (h n ) were obtained from the brain homogenates of the chickens that died on days post intranasal inoculation with the p viruses. although mortality rate of chickens inoculated with the p viruses was equal to that with p viruses, enhancement of pathogenicity was observed in intranasal inoculation study; all of the chickens inoculated with rgvac sub-p (h n ) were infected, and time to death was shortened to - days post inoculation in chickens with rgvac ins-p (h n ) (data not shown). to investigate whether tissue tropism of the viruses was involved in their pathogenicity, we determined viral titers in the tissue and blood samples from -week-old chickens intranasally inoculated with each virus on days post infection ( table ) . rgy (h n ) and rgvac (h n ) were scarcely recovered from the samples, and the mutant strains before passage showed broader tissue tropism than the parental viruses. none of the chickens inoculated with rgy sub-p (h n ) showed any signs of disease, and viruses were recovered from each of the samples except the brain and the blood. one chicken inoculated with rgvac sub-p (h n ) showed clinical signs such as depression, and viruses were recovered from virtually all of its organs and blood samples. two of three chickens inoculated with rgvac ins-p (h n ) showed disease signs, and one died days post inoculation. the viruses were recovered from almost all samples of the two chickens showing signs of disease. p viruses were efficiently replicated in systemic organs of the chickens as compared with p viruses. throughout the study, the viruses were recovered from the brains of all of the chickens showing clinical signs. here, we demonstrated that the h influenza virus acquired intravenous pathogenicity after a pair of di-basic amino acid residues was introduced into the cleavage site of the ha and passaged in chicks. rgy sub-p (h n ) killed % of chickens infected intravenously, and its pathogenicity was comparable to that of hpaivs (table ) . however, chickens intranasally inoculated with rgy sub-p (h n ) did not show any clinical signs of disease (data not shown). these results are consistent with a previous study in chickens that found some h influenza viruses did not show intranasal pathogenicity although their intravenous pathogenicity index was over ae , classified as hpaiv according to the definition by european union. ohuchi et al. reported that the insertion of additional basic amino acids into the h ha cleavage site resulted in intracellular proteolytic cleavage. other groups reported that h and h has tolerated amino acid mutations into their cleavage sites, and the viruses with the mutated has replicated in mdck and ⁄ or qt cells in the absence of trypsin. , the results in the present study is in agreement with these, namely, cleavage-based activation by a ubiquitous protease is not restricted to the h and h has. the intranasal pathogenicity of the h and h mutants were different (data not shown), although these viruses similarly replicated in mdck cells in the absence of trypsin and killed chickens by intravenous inoculation ( table ) . the viruses were recovered from the brain and the blood of some chickens infected with rgvac mutants (h n ), and morbidity was closely associated with viral titers in the brain (table ) . on the other hand, no viruses were recovered from the brain of chickens infected with rgy mutants (h n ), explaining why rgy sub-p (h n ) did not show intranasal pathogenicity. all the viruses passaged in the air sacs of chicks killed chicken embryos by hours post allantoic inoculation (data not shown). rgvac sub-p (h n ) and rgvac ins-p (h n ) were more pathogenic to chicken embryos than rgy sub-p (h n ); the allantoic fluid obtained from the embryonated eggs inoculated with the h viruses passaged in air sacs was turbid. it has been reported that infection of a highly pathogenic h virus were strictly confined to endotherial cells in chicken embryos or chickens. , therefore, it is suggested that endotheliotropism differed between the h and h viruses passaged in air sacs and affected their intranasal pathogenicity. taken together, it is assumed that rgvac sub-p (h n ) and rgvac ins-p (h n ) showed marked intranasal pathogenicity with high levels of viremia caused by replication in vascular endothelial cells, leading to invasion of the brain. in the intravenous experiment, rgy sub-p (h n ) easily reached systemic organs, including the brain hematogenously, replicated through the cleavage of ha by a ubiquitous protease, and then exerted its pathogenicity. further study including a pathological analysis is currently underway to test this hypothesis. for all hpai viruses of subtypes h and h known to date, the cleavage of ha occurs at the c-terminal r residue in the consensus multibasic motifs, such as r-x-k ⁄ r-r with r at position p and k-k ⁄ r-k ⁄ t-r with k at p , and leads to a systemic infection. early studies demonstrated that the ubiquitously expressed furin and pcs are activating proteases of hpai viruses. furin and pcs cleave the consensus multi-basic motif r-x-k ⁄ r ⁄ x-r with r at position p . however, replacement of p r by k and a nonbasic amino acid significantly suppresses the processing activities of furin and pcs. most of the type ii transmembrane serine protease identified so far recognize a single r at position p , but the newly isolated mspl and its transcript variant tmprss preferentially recognize paired basic residue, particularly r and k at position p , at the cleavage site. [ ] [ ] [ ] thus, mspl and tmprss can activate various bioactive polypeptides with multibasic residue motifs, including fusogenic viral envelope glycoproteins. the present study was designed to characterize the proteolytic processing of the hpai virus ha by mspl and tmprss in comparison with furin. hpai virus a ⁄ crow ⁄ kyoto ⁄ ⁄ (h n ) was isolated from embryonated eggs inoculated with tracheal homogenates from dead crows. then, the mutant ha sequence was constructed by changing r residue to k residue (n'-rkkr-c' to n'-kkkr-c') at the ha cleavage site by sitedirected mutagenic pcr as described. we used human cell line ecv , which expresses mspl and tmprss at levels below detection, and established the cells stably expressing mspl and tmprss , such as ecv -mspl and ecv -tmprss . to determine the cleavage specificities of mspl ⁄ tmprss and furin, peptides ( lg each) were incubated with ae mu mspl ⁄ tmprss for hour and furin for hours at °c, respectively. after incubation, the samples were separated by reverse-phasehigh-performance liquid chromatography (rp-hplc) with the use of a c column. the elution samples were then identified by amino acid sequence analysis and by maldi-tof-ms. we analyzed the cleavability of -residue synthetic peptides derived from ha cleavage sites of hpai strains, such as a ⁄ chick ⁄ penn ⁄ ⁄ (h n ) and a ⁄ fpv ⁄ rostock ⁄ (h n ), and low pathogenic strain a ⁄ aich ⁄ ⁄ (h n ). after incubation with human mspl or human furin, the digested samples were separated by rp-hplc, and peptide fragments were characterized by mass-spectrometry and protein sequencing. in contrast to the low cleavage efficiencies of the h ha peptide with a single r at the cleavage site ( figure a) , both the h ha peptide with the k-k-k-r motif ( figure b ) and the h ha peptide with the r-k-k-r motif ( figure c) were fully processed at the correct positions by mspl within hour. in the case of h ha peptide with multiple basic residues, mspl cleaved two carboxyl-terminal sides of r in the cleavage site sequence of n'-k-k-rfl-k-k-rfl-g-c', while furin cleaved only at a single site of r with r at position p , n'-k-k-r-k-k-rfl-g-c' in the presence of mm cacl . these cleavage site specificities of furin were consistent with that reported for the h ha peptide of hpai virus a ⁄ hong kong ⁄ ⁄ (h n ) with r-k-k-r motif. however, the h ha peptide with k at position p ( figure b) was hardly cleaved by furin under the same experimental conditions. tmprss showed similar results (data not shown). these findings suggest that mspl and tmprss cover diverse cleavage specificities, including non-susceptible specificity to furin. full length recombinant ha of hpai virus with kkkr cleavage motif was converted to mature ha subunits with membrane-fused giant cell formation in mspl or tmprss transfectant cells. in addition, this conversion was suppressed by bowman-birk trypsin inhibitor, a membrane non-permeable highmolecular mass inhibitor against mspl ⁄ tmprss . to test for the generation of infective virus, the conditioned media of -day culture of ecv -wt and ecv -mspl cells infected with wt and mutant hpai h n viruses were inoculated into newly prepared cells and cultured for hours. although spreading of wt virus infection with ha cleavage motif of r-k-k-r was detected from the conditioned medium of both ecv -wt and ecv -mspl cells, that of mutant virus with ha cleavage motif of k-k-k-r was only detected from the condition medium of ecv -mspl cells. these results strongly suggest that the expression of mspl, but not furin, potentiates multicycles of hpai virus with k-k-k-r ha cleavage motif. seasonal human influenza a virus has have consensus monobasic cleavage site sequence, n'-q ⁄ e-x-rfl-g-c', and all hpai virus has have two types of cleavage site sequences with multiple basic amino acids, n'-r-k ⁄ r-k ⁄ r ⁄ x-rfl-g-c' with r at position p in a large number of hpai viruses and n'-k-k ⁄ r-k ⁄ t-rfl-g-c' with k at position p in a small number of hpai viruses. figure shows furin efficiently cleaved synthetic hpai a ⁄ hong kong ⁄ ⁄ (h n ) ha cleavage site peptide with the r-k-k-r motif, but hardly cleaved the hpai virus a ⁄ chick ⁄ penn ⁄ ⁄ ha cleavage site peptide with the k-k-k-r motif. furthermore, cleavage of the full-length ha of hpai virus with r-k-k-r motif was detected, but cleavage of hpai virus ha with k-k-k-r motif was hardly detected in ecv -wt cells containing furin ( figure ). these substrate specificities of furin suggest that proteases other than furin and pc ⁄ play a role in the processing of has of hpai virus with k-k ⁄ r-k ⁄ t-r cleavage motif. mspl and tmprss show unique cleavage site specificities of the double basic residues at the cleavage site, and r or k at position p greatly enhanced the efficiency, which none of the other ttsps have shown similar substrate specificities so far. furthermore, infectious and multicycle viral replication along with ha processing was also noted in genetically modified mutant recombinant live hpai virus a ⁄ crow ⁄ kyoto ⁄ ⁄ (h n ) with k-k-k-r cleavage motif in ecv -mspl cells (figure ) . these results were supported by the data of two cleaved peptides by mspl in figure c . these findings suggest that mspl has diverse cleavage specificities and may cleave ha at least two sites, although multiplicity of the mutant hpai virus was observed under the conditions. these results also suggest that mspl and tmprss in the membrane might potently activate the ha membrane fusion activity of hpai viruses and promote their spread. highly pathogenic avian influenza viruses replicate in various organs in birds, and the ha processing proteases might be widely distributed in these organs. indeed, tmprss and mspl are ubiquitously expressed in almost all human organs tested and are highly expressed in lungs, leukocytes, pancreas, spleen, and placenta. , in addition, mspl and tmprss are strictly localized in the plasma membranes, suggesting that proteolytic activation of hpai virus ha occurs not only through the trans-golgi network by furin and pc ⁄ , but also on the cell surface by mspl and tmprss . the pb -f protein, which is translated from the + reading frame of the pb gene segment, has been linked to the pathogenesis of both primary viral and secondary bacterial infections in a mouse model. - a mitochondrial targeting sequence is located in the c-terminal portion of the pb -f open reading frame, and expression of full length pb -f has been associated with mitochondrial targeting and apoptosis in a monocyte dependent manner. , it has been theorized that enhanced virulence could result from mitochondrial disruption with subsequent cell death mediated by pb -f . , a suggested second function of the pb -f protein is that it enhances immunopathology by triggering the inflammatory response. , in earlier studies from our group, the pro-inflammatory phenotype was markedly upregulated when the pb -f from the pandemic strain was expressed, arguing that this protein may be an important virulence factor for highly pathogenic pandemic viruses. , in this report we analyze the pb -f protein's contribution to pathogenesis in a mouse model, examining both inflammation and cell death. pb -f proteins from a variety of epidemiologically important iav strains including all pandemic strains from the th century, a highly pathogenic avian influenza virus of the h n subtype, and representative seasonal strains were utilized to determine the relevance to pandemic disease. we demonstrate that macrophage mediated immunopathology, but not apoptosis, are relevant functions of pb -f proteins from past or potential pandemic influenza viruses. using the predicted amino acid sequences of the pb -f proteins from pr , a ⁄ brevig mission ⁄ ⁄ , ⁄ singapore ⁄ ⁄ , a ⁄ hong kong ⁄ ⁄ , a ⁄ wuhan ⁄ ⁄ , and a ⁄ vietnam ⁄ ⁄ , peptides from the c-terminal end were synthesized as described. an additional n-terminal peptide was synthesized from the pr sequence as a positive control (mgqeqdtpwilstghistqk) as described. a panel of viruses were reverse engineered as described , and included laboratory strain pr , a virus unable to express pb -f (dpb -f ⁄ pr ), or expressing the pb -f of the pandemic strain ( pb -f ⁄ pr ) or the truncated h n strain (beij pb -f ⁄ pr ). , in addition, : reassortants encoding pb gene segments from a *current address: department of immunology and microbiology, university of melbourne, melbourne, vic., australia. highly pathogenic avian influenza of the h n subtype (h n pb ⁄ pr ), or from a human h n strain (h n pb ⁄ pr ) were utilized along with their isogenic deletion mutants for pb -f (h n dpb -f ⁄ pr and h n dpb -f ⁄ pr ). cell lines and cell death assays raw . cells were grown under conditions as described. cells were infected with one multiplicity of infection (moi) of virus for - hours, or exposed to lm (final concentration) of peptides derived from the c-terminal portion of pb -f for hour. cells from the supernatant and monolayers were harvested, washed, and stained with annexin (apc) and propidium iodide (pi) (becton dickinson, san jose, ca, usa), then analysed for cell death as described. six-to eight week old female balb ⁄ cj mice (jackson laboratory, bar harbor, me, usa) were maintained in a biosafety level facility in the animal resource center and procedures approved by the animal care and use committee at sjcrh. infectious agents and peptides were diluted in sterile pbs and administered intranasally to anesthetized mice (n = - ) in a volume of ll ( ll per nare) and monitored for overt signs of illness and weight loss daily. following euthanasia by co inhalation, the trachea was exposed and cannulated with a gauge plastic catheter (bd insyte; becton dickinson, sandy, ut, usa). bronchoalveolar lavage fluid (balf) was collected, red blood cell depleted, and cellular content analyzed via flow cytometry as described. one way analysis of variance (anova) was used for multiple comparisons of cell death and cellularity of balf. a p-value of < ae was considered significant for these comparisons. graphpad prism version . for windows (graphpad software, san diego, ca, usa) was utilized for all statistical analyses. to assess the contribution of pb -f to inflammation, we utilized a panel of previously described reverse engineered viruses in the mouse infection model. , the effect of pb -f expression was observed clearly in the inflammatory infiltrate in response to infection in the lungs. deleting pb -f from pr or expression of the c-terminally truncated beij pb -f had a significantly reduced influx of macrophages ( figure a) . expression of the pb -f caused similar inflammatory effects as the pr virus. disruption of pb -f expression the virus containing the h n pb gene segment in a pr background also significantly decreased the inflammatory response compared to the virus maintaining the ability to express full length pb -f ( figure a) . however, no differences were seen that could be attributed to the h n derived pb -f . the lungs of mice infected with the panel of pb -f variant viruses were examined at hours. pathologic changes typical of pr viral infection were observed in all lungs. these typical findings included perivascular inflammation, airway necrosis, hemorrhage, and deposition of cellular debris (figure ). in the lungs of mice infected with pr or pb -f ⁄ pr , however, significantly more perivascular cuffing was noted, with a prominent increase in numbers of macrophages (figure a, c) . the overall number of inflammatory cells throughout the lungs, including both airways and alveoli, was quantitatively greater in these mice than in mice infected with dpb -f ⁄ pr or beij pb -f ⁄ pr ( figure b, d) . as the function and influence of pb -f protein on normal viral function is not currently understood, and given the abrogation of enhanced inflammation induced by the truncated pb -f beij ⁄ pr virus, we sought to elucidate whether the c-terminal domain of pb -f could alone induce this inflammatory response. mice were exposed to a panel of peptides and were euthanized hours later for collection of balf. significant influxes of macrophages into the balf were seen following exposure to c-terminal pb -f peptides derived from pr , the pandemic strains from (h n ), (h n ), and (h n ), and the h n virus compared to controls ( figure b) . similar effects were not seen with the peptide derived from a more recent h n strain, a ⁄ wuhan ⁄ ⁄ . when peptide exposed mice were followed for morbidity for days, peptides proven to induce a heightened inflammatory response correlated strongly with overt clinical signs of illness (data not shown). thus, the ability to cause lung inflammation appears to be a property of pb -f proteins of viruses containing pb gene segments reassorted directly from the avian reservoir. the pb -f protein may contribute to virulence by rendering the host cellular immune response ineffective through inducing apoptosis. we sought to determine whether this was an epidemiologically important function for combating the host immune response to infection by testing the ability of pb -f proteins from several different iav strains to cause cell death. we therefore infected raw . cells with the panel of recombinant viruses at an moi of for - hours. as has been demonstrated previously, , , pr virus induces significant cell death compared to uninfected controls ( figure c ). when raw . cells were infected with pr virus, necrotic death peaked hours after infection. viruses lacking the c-terminal portion of pb -f , including the dpb -f ⁄ pr and the beij pb -f ⁄ pr were unable to cause cell death ( figure c ). in addition, expression of the pb -f also did not cause significant increases in cell death over controls. expression of pb -f or deletion of pb -f in either an h n or h n pb gene segment background similarly did not alter the cell death phenotype. to examine additional strains for which we did not have isogenic virus pairs, we next exposed the balbcj mouse derived macrophage cell line raw . to the panel of pb -f peptides derived from pr , the pandemic strains from (h n ), (h n ) and (h n ), and the h n for hours. cell death in raw . cells was caused only by the peptides derived from the laboratory strain pr and the peptide derived from the pandemic strain ( figure d ). viability was not affected by exposure of raw . to peptides derived from other virus strains. we conclude from these data that the mechanism by which pb -f contributes to the pathogenicity of pandemic influenza is unlikely to be through its reported ability to cause cell death. these data presented here demonstrate that the lung inflammatory response is enhanced by the influenza a virus pb -f protein in a mouse model. this inflammatory response was characterized by increased cellular infiltration of macrophages into the interstitial and alveolar spaces of the lungs, as well as enhanced perivascular inflammation, airway necrosis, hemorrhage, and deposition of cellular debris. this augmentation was shown to be induced by pb -f proteins only from those strains contributing to the formation of all pandemic strains of the th century and from the currently circulating, highly virulent h n strains that constitute an imminent pandemic threat. the iav h n strains circulating in humans since around code for a truncated pb -f . these viruses may lack the cterminal residues responsible for the inflammatory effects demonstrated in this publication. additionally, recently circulating h n strains, in contrast to their pandemic forbear from , have lost the capacity to cause pb -f mediated inflammation through mutation of the c-terminus of this protein. in a novel h n iav emerged from an animal reservoir and caused a human pandemic. disease burden from this strain has been considered mild in contrast to the three pandemics of the th century. the reasons for this disparity in pathogenesis are unclear. an examination of the origins of the three th century pandemics shows that only the hemagglutinin (ha) and pb gene segments were reassorted directly from the avian reservoir in every case, suggesting gene products of one or both of these may be important. the ha surface glycoprotein provided the antigenic novelty required for the each virus to achieve pandemic status. however, the significance of inclusion of a novel pb gene segment in each of the th century pandemics is not yet understood. we show here that the pb -f of these pandemic strains contributes to virulence through induction of inflammatory responses. thus pb -f may serve as a marker of the pathogenicity of pandemic strains. since the h n strain codes a truncated pb -f of only predicted amino acids, the lack of pb -f mediated inflammation may account in part for its relatively lower virulence. , of the panel of pb -f proteins studied, only that from the laboratory strain pr was capable of rendering responding host-immune cells ineffective by induction of cell death. we therefore hypothesize that molecular signatures specific to induction of apoptosis may have been lost through genetic mutation of the pb -f gene throughout the evolution of the iavs. our findings suggest that this apoptotic function is unlikely to be important for the virulence of any of the known pandemics. rather, the inflammatory phenotype appears to be the dominant contribution of pb -f to pandemic disease. influenza virus-cytokine-protease cycles are principal mechanisms of multi-organ failure in severe influenza and therapeutic approaches introduction influenza a virus is the most common infectious pathogen in humans, causing significant morbidity and mortality, particularly in infants and the elderly. mof with severe edema is observed in the advanced stage of influenza pneumonia. however, the relationships amongst factors that induce vascular hyper-permeability in severe influenza remain unclear. it is reported that significant increases in levels of pro-inflammatory cytokine levels, such as tnf-a, il- , and il- b, affect host survival both positively and negatively. the inflammatory response affects cell adhesion, permeability, apoptosis, and mitochondrial reactive oxygen species, potentially resulting in vascular dysfunction and mof. in addition, iav infection up-regulates several cellular proteases including ectopic trypsin and mmp- . up-regulated ectopic trypsin mediates the post-translational proteolytic cleavage of viral envelope hemagglutinin (ha), which is crucial for viral entry and replication and the subsequent tissue damage in various organs. the aim of the this study was to define the pathogenic impact of cytokine storm in iav infection and the molecular mechanisms by which pro-inflammatory cytokines and proteases cause vascular dysfunction in animal model. weanling female mice aged weeks (c bl ⁄ crslc) were infected with iav ⁄ wsn ⁄ ( pfu) with and without treatment of pdtc ( . mg ⁄ kg), nac ( mg ⁄ kg), and ndga ( mg ⁄ kg). these inhibitors were administrated once daily for days after infection. the levels of cytokines in tissue homogenates were measured by elisa kits. the effect of inhibitors on viral replications was determined by real-time pcr. gelatin zymography and western blotting were conducted as reported previously. host cellular responses in the airway after iav infection figure shows schematic view of typical biological responses in the airway of mice after iav infection. an initial response before viral proliferation is significant increases in pro-inflammatory cytokine levels. immediately after cytokine inductions, there is a marked up-regulation of ectopic trypsin along with an increase in virus titer in the airway, lung, and brain. ectopic trypsin mediates the post-translational proteolytic cleavage of iav ha, which is crucial for viral entry and replication and the subsequent tissue damage in various organs. we also found that iav infection markedly induces mmp- and matrix degradation. just after the peak of viral proliferation, the innate and adaptive immune responses of protective immunity are induced for defense and recovery, or oppositely on rare occasions, mof with vascular hyper-permeability is started into the advanced stage of influenza. the levels of tnf-a and il- in the lungs were increased persistently for days after iav wsn infection, and that of il- b peaked at days - post-infection (figure a ). since these cytokine responses are associated with activation of nf-jb and ap- , we treated mice once daily for days with anti-oxidant inhibitors: pdtc and nac against nf-jb activation, and ndga against ap- activation. pdtc and ndga significantly suppressed the up-regulation of tnf-a and il- b (p < . ), and nac suppressed tnf-a (p < . ), and il- (p < . ) at day post-infection. gelatin zymography showed up-regulation of ectopic trypsin and mmp- in mice lung, brain, and heart during infection for days ( figure b ). trypsin and mmp- induction was inhibited by treatment with pdtc, nac, and ndga, probably via blockade of nf-jb and ap- binding in the promoter region of the genes. viral rna replication in various organs at day post-infection was suppressed by more than one order of magnitude by pdtc, nac, and ndga ( figure c ). suppression of viral multiplication and induction of cellular factors by pdtc, nac, and ndga, significantly improved the survival of mice at day post-infection, the late stage of infection ( figure d ). to elucidate the mechanisms underlying brain vascular dysfunction of influenza-associated encephalopathy, changes in the levels of tight-junction proteins, intracellular zonula occludens- (zo- ) and transmembrane occludin, and the matrix protein laminin, were analyzed by western blotting. marked reductions in the expression levels of tight-junction constituents were detected at day post-infection, which were partly rescued by pdtc, nac, or ndga (figure e ). no other tight-junction protein, claudin- or matrix fibronectin and type iv collagen, were affected. the present study reports several new observations: (i) proinflammatory cytokines, tnf-a, il- b, and il- , when up-regulated by iav infection, induce trypsin and mmp- expression in various organs in mice; (ii) inhibitors of nf-jb and ap- effectively suppress the up-regulation of proinflammatory cytokines, trypsin, and mmp- and improve survival rates of infected mice. based on these results, we propose the 'influenza virus-cytokine-protease cycle' hypothesis as one of the mechanisms of vascular dysfunction in mof with cytokine storm in severe influenza and influenza-associated encephalopathy. the significance of pro-inflammatory hyper-cytokinemia, or 'cytokine storm,' in the pathogenesis of iav infection remains unclear. on the positive effects, cytokines promote lymphocyte activation and infiltration at the sites of infection and exert direct antiviral effects. however, on the negative effects of excess cytokines, the hyper inflammatory process evoked by viral infection may become harmful through intracellular activation of nf-jb, ap- , and the janus kinase-signal transducers and activators of transcription signaling pathways. , [ ] [ ] [ ] the in vivo experiments presented here showed that nf-jb and ap- inhibitors markedly suppress the expression of cytokines, trypsin, mmp- , and viral replication, resulting in a significant increase in the survival of infected mice. furthermore, cytokines interact with mitochondria to increase the production of reactive oxygen species, resulting in the production ⁄ activation of vasodilatory mediators such as nitric oxide and bradykinin, and subsequent endothelial dysfunction and edema in various organs. the molecular mechanisms underlying tight-junction disruption in endothelial cells and vascular hyper-permeability following the 'cytokine storm' remain unclear. tnfa up-regulation alters the cellular redox state, reduces the expression of four complex i subunits by increasing mitochondrial o ) production and depleting atp synthesis, decreases oxygen consumption thereby resulting in mitochondrial damage, , and increases [ca + ] i atp depletion dissociates zo- from the actin cytoskeleton and thereby increases junctional permeability. endothelial dysfunction induced by 'influenza virus-cytokine-protease cycle' in the early stage of severe influenza may further affect various circulating factors, coagulation factors and complement systems, and vascular interacting cells, such as neutrophils, macrophages and lymphocytes. mof is the final outcome of metabolic and mitochondrial fuel disorder, immunosuppression, endocrine disorder, and tissue injury followed by endothelial dysfunction in many organs. another key pathway of acute lung injury in the highly pathogenic avian influenza virus h n and acute respiratory syndrome-corona virus infection reported recently involves oxidative stress and formation of oxidized phospholipids, which induce lung injury via toll-like receptor signaling pathway. in addition to these data, up-regulated trypsin and pro-inflammatory cytokines may also affect tissue destruction and immunosuppression in the late stage of iav infection. further studies are required on the role of the 'influenza virus-cytokine-protease cycle' in the pathogenesis of mof, particularly in the late stage of viral infection. though influenza a virus replication kinetics and host responses have been previously studied in umbilical vein endothelial cell or transformed endothelial cell lines, the tropism of influenza a virus including h n and pandemic h n pdm for primary human lung microvascular endothelial cell has not been well defined. in this study we employed primary human lung microvascular endothelial cells, which are more physiologically relevant for understanding pathogenesis of influenza in the lung as to obtain a better understanding of the links of endothelial cell infection to systematic virus dissemination and multiple organ involvement in severe human influenza. supernatants of cells infected at moi of two were collected for cytokine protein assays, and total rna was extracted for gene expression analysis using qpcr. we found that seasonal influenza h n and h n viruses initiated viral gene transcription and viral protein expres- sion, but did not produce infectious progeny, while the highly pathogenic avian influenza h n and the pandemic influenza h n pdm virus could replicate even with the absence of exogenous protease (figure ) . furthermore, when compared to seasonal h n and h n , the h n virus was a more potent inducer of cytokine and chemokine including ifn-b, mcp- , rantes, ip- (figure ) , and il- , in virus infected endothelial cells, whereas h n pdm induced intermediate levels of cytokine and chemokine. avian influenza h n and pandemic h n pdm virus (but not the seasonal h n and h n virus) can productively replicate in human lung microvascular endothelial cells. this is likely to be of relevant to pathogenesis and provides a possible explanation for the extra-pulmonary infection seen in animal infection models. this extra-pulmonary spread may support the previous speculation and anecdotal evidence that h n and h n pdm virus can infect the gastrointestinal tract through the virus dissemination from the infected respiratory tract as the first target cells for influenza infection. [ ] [ ] [ ] in addition, the release of proinflammatory cytokine and chemokine induced by influenza h n and h n pdm virus infection in lung microvascular endothelial cells may be important contributors to the pathogenesis of severe human influenza disease leading to endothelial cell dysfunction that contributes to severe pulmonary disease symptoms. during its replication, influenza virus utilizes the host cellular machinery for many aspects of its life cycle. characterization of such virus-host protein-protein interactions is a must to identify determinants of pathogenesis. the m ion channel protein plays a crucial role during the entry and late stages of the viral life cycle where its c-terminal domain, well conserved among influenza a viruses, is accessible to cellular machinery after fusion with endosomal membrane and during its trafficking along the secretory pathway prior to assembly and budding. the aim of the study is to identify cellular interactants of m that play important regulatory roles during influenza infection. to identify cellular partners of m we performed a genome-wide yeast-two-hybrid (y h) screening approach using the cytosolic domain of m as bait and a human placenta random primed cdna library as prey and tested more than million interactions. from the y h screening, an interesting interaction with the human annexin a (anxa ) protein, a member of annexin family proteins that binds to phospholipds in a ca + -dependent manner, was identified. co-immunopre-cipitation of myc-tagged anxa and viral m proteins coexpressed in hek t cells after transfection and infection confirmed the direct interaction between anxa and m . we further investigated whether this interaction had any functional significance with regards to influenza life cycle. using a rna interference strategy to silence the anxa gene in human lung epithelial a cells, we observed increased progeny virus titers either in a single or multiple viral growth kinetics study, suggesting a negative regulatory role for anax during viral infection (figure ). a novel interaction between m and anxa was identified. more functional studies are in progress to define precisely the potential negative regulatory role of this interaction during viral infection. a systematic dissection of the viral life cycle will be performed to identify the step(s) affected by the anxa cellular factor using specific assays such as real-time quantitative rt-pcr in a single or multiple viral growth kinetics study, cell transduction with ha-and m -pseudotyped lentiviral particles, virion attachment and internalization assay, immunofluorescence staining of np protein as a marker of viral ribonucleoproteins localization, viral polymerase activity measurement, and viral budding observation by electron microscopy. rna extraction was achieved by qiagen biorobot ez prior to respiratory multiplex pcr analysis. what remained of the extracted material of each specimen was stored by refrigeration at °c. electronic patient records were searched for parameters, such as c-reactive protein (crp), white cell count (wcc), length of admission in days, and patient co-morbidities. patients were divided into three groups according to clinical severity: mild, moderate, and severe. the 'mild' group comprised of those admitted for three days or fewer, or not admitted at all. the 'moderate' group comprised those who required admission to hospital for more than days as a result of swine flu, but who did not require admission to an intensive care unit (itu). the 'severe' group comprised those who had required itu admission. invitrogen ' · reaction mix': ae mm of each dntp + mm magnesium sulphate. primer ⁄ probe mix recipe applied biosystems fast real-time pcr system, 'respiratory multiplex' program. well content ll; thermocycler initial stage ae °c for minutes, then °c for minutes. subsequent cycles of ae °c for seconds followed by °c for seconds for cycles. sequence detection software version . (applied biosystems). of clinical isolates analyzed, all samples produced amplification of pdh material; produced amplification of both swine flu and pdh material. human male dna (lot no. at ng ⁄ l, applied biosystems) at concentration calculated at ae cells ⁄ ll was diluted from ) to ) , yielding mean average ct values of respectively ae , ae , ae , and ae . plotting log of cell number versus ct gave a y = mx + c line from which ct could be interpolated into cell numbers. for swine flu quantification, a sample of swine flu ct ae was diluted through ) to ) . it must be noted that due to variability in resultant swine flu ct values, repetitions at these dilutions were done using an rna carrier ( lg ⁄ l, qiagen; cat no. ) in place of rnasefree water. the ) concentration was positive in nine out of assays; this fraction was used in the calculation described by simmonds to obtain a copy number of targets per reaction by the equation copy value = )ln(f), where f is decimal fraction of failure rate. here, f = ⁄ = ae ; )ln ae = ae copies. a control curve was generated with ct values of ae , ae , ae , and ae giving copy values of , ae , ae , and ae , respectively. using excel (microsoft office, ), these control series were adapted into formulae to convert swine flu and pdh ct values into copy numbers of these elements per reaction. simple division derived a value for swine flu copy per pdh copy, but this was chosen to be expressed as swine flu copy number per human cells. this will be referred to as the 'c' value. forty-two patients had known clinical details; average age was ae , female to male ratio : , and average admission length of days. of the mild group (n = ), nine cases were not admitted to hospital. of the remainder, the mean average admission length was ae days. mean average c value for all samples was ae · , with a standard deviation of ae · ; geometric mean was ae , and median average was ae . log(mean average c value) is shown for each severity group and for identified risk factors in the 'mild' severity group (figures a, b respectively) . in each case variation was too great to yield statistical significance. figure shows the range of c values observed in the 'moderate' severity group. > - · ; < - · > - · ; < - · > - · ; < - · > - · ; < - · > - · ; < - · > - · ; < - · > - · ; < - · > - · ; < - · > - · ; < - · > · ; < · > · ; < · > · ; < · > · ; < · > · ; < · > · ; < · in a study by duchamp et al., no significant correlation was observed between viral ct value and presence or absence of cardiaorespiratory disease, myalgia, digestive symptoms, or upper or lower respiratory tract infection (although a trend was observed towards patients presenting with signs of upper respiratory tract infection). to our knowledge, no other study has used a dual pcr for analysis of respiratory virus concentrations, and no study has attempted to correlate biochemical markers with respiratory virus concentration. the data exhibited a spectrum of c values, from values < · ) to over · . the three severity group standard deviations all overlapped with each other, preventing statistical significance. analysis of co-morbidities showed a high mean average c value when asthma was present ( ae · ), but again this was associated with an excessive standard deviation. whereas the median average c value in the presence of asthma was higher than the overall average c value ( ae versus ae ), it was significantly lower than the median c value when no co-morbidity was documented ( ae ). there are multiple caveats that may be the cause of such variety of c values obtained. the duration between initial rna extraction and study pcr had a range of to days, with mean average delay of days. the degradation of viral rna is an important contributor to assay variance and failure; rna degradation in clinical samples has been studied. [ ] [ ] [ ] degradation of human dna in clinical samples may have occurred. several studies have chartered degradation of stored human dna. , with regards to sampling, the clinical collection of throat swabs is naturally variable according to the method of the collector. a small number of bronchoalveolar lavage samples were analyzed, yet did not amplify, presumably due to rna degradation. the upper respiratory tract may be only a physical stepping stone for the virus, and take no further role in pathogenesis of severe disease (although undoubtedly is crucial for transmission). interestingly, a ferret study of pathogenesis observed that swine flu yields from the upper respiratory tract were greater than those given by ordinary seasonal h n , with consequently increased shedding. the review by mansfield cites significant findings regarding influenza pathogenesis, including the predilection of h n strains for type ii pneumocyte cells and alveolar macrophages. it also highlights the limitation of knowledge through dearth of human autopsy studies; an exception is the recognition of haematophagocytic syndrome in severe cases. it is known that specific immunoglobulin is effective against establishment of infection in the upper respiratory tract, whereas specific cytotoxic t lymphocytes (ctls) are necessary for clearance of the virus from the lower respiratory tract. it is also suggestive that a gap of two whole days transpires between initial infection and instigation of a specific immune response. it is plausible that in the healthy individual, virus progression is confounded by efficient natural mucosal immunity, in part through good secretory immunoglobulin levels. airway inflammation associated with asthma exacerbation is known to increase both risk of respiratory viral infection and poorer outcome. it is unproven but likely that the local inflammatory processes give rise to increased virion burdens in the upper airways; however, the same effect is conceivable for epithelial cell turnover. there will likely be variance within each clinical category due to patient circumstances and clinicians' judgment of required admission. unfortunately, the duration of symptoms prior to swab collection was often omitted in the clinical notes. finally, stratification of patient group by receipt of antiviral treatment was not studied. no correlations were observed with c values and crp, wcc or admission length. trends were observed towards higher c values in 'mild' cases, but without statistical significance. the relative small study size, coupled with the intrinsic variability of the parameters studied, warrants larger, better controlled, prospective studies to elucidate clinical use of the c value for influenza illness prediction and management. in mid-april a novel variant of a(h n ) influenza virus began to spread rapidly throughout the world, causing the first pandemic of the st century. the majority of the cases associated with this new virus show to be mild, but severe and fatal cases have been reported. molecular markers associated with severity have already been identified, as is the case of the mutation d g. resistant viruses to antiviral drugs have also been identified, highlighting the importance of rapid determination of the antiviral drug profile. global a(h n ) genetic characterization, molecular evolution dynamics, antiviral susceptibility profiles, and inference of public health implications require nation and region wide systematic analysis of circulating virus. the objective of this ongoing research study was, primarily, to thoroughly characterize the genetic profile and evolution of the emergent influenza a(h n ) virus circulating in portugal and its phenotypic expression on antiviral drugs susceptibility. the cases considered in this study were obtained from the community and from two collaborating hospitals in lisbon -a reference hospital for adults (hospital de curry cabral) and a reference hospital for children (hospital dona estefânia). the cdc real-time pcr protocol, recommended by world health organization (who), was the method used to confirmed all influenza a(h n ) cases. from a total of a(h n ) positive cases diagnosed and confirmed, were selected for this study, taking in consideration that they should cover the period of epidemic activity in portugal and include cases from persons belonging to risk groups and cases associated with more severe clinical features. ninety-six a(h n ) strains were isolated in mdck-siat cells, from combined naso-oropharyngeal swabs. for the evaluation of the genetic profile of a(h n ) virus circulating in portugal, of the isolates were characterized by genetic analysis of the ha, na, and mp genes. the remaining five gene segments (pb , pb , pa, ns, and np) were also sequenced for six of this isolates. briefly, sequencing was performed according to the protocol developed by cdc and recommended by who, using bigdye terminator v. . technology. nucleotide sequences were determined in a dna automatic sequencer abi prism xl genetic analyzer. for each genomic segment, genetic analysis was performed with lasergene v. . software (dnastar inc, usa) using an average of - overlapping readings, including sense and antisense, for precise nucleotide and amino acid sequence determination. genetic mutation and phylogenetic analysis were performed by neighbor-joining method, using mega . software, against published sequences from the vaccine strain (a ⁄ california ⁄ ⁄ ) and from selected a(h n ) strains available on gisaid epiflu database. all mutations were identified with reference to the vaccine strain genome sequence. antiviral drug susceptibility profile of a(h n ) influenza virus circulating in portugal was evaluated both phenotypically and genotypically for nais and genotypically for amantadine. phenotypic evaluation to nais, oseltamivir and zanamivir, was performed for all isolates by ic determination through munana fluorescence assays. genotypic evaluation was performed by searching for mutations associated with resistance to nais in all na gene sequences. amantadine susceptibility profile was performed for all isolates by searching on m sequence for the molecular markers associated with resistance to this antiviral drug (l f ⁄ i; v a ⁄ d; a t; s n; g e). genetic characterisation of the ha subunit of ha reveals point mutations in different strains. all analysed strains present p s and i v mutations, which distinguish them from the vaccine strain ( figure a ). thirty-three of the sequenced strains group in the s t branch. this mutation is referred in the literature as being associated with the putative antigenic site ca. most of these strains ( ) further subgroup in the d e branch, this mutation being associated with one loop of the receptor-binding site. from the early to the late epidemic period, an increased circulation of virus carrying the mutation s t was observed. this is in agreement with the association between this mutation and an enhanced viral fitness that is described in the literature. additional mutations were also observed in a small number of virus, of which we highlight: regarding the genetic characterisation of na, the majority of strains analysed ( of ) presents the mutations n d and v i ( figure b) . as mutation s t in ha gene, these two na mutations are described in the literature as associated with enhanced viral fitness. the few strains not carrying these mutations have circulated in the beginning of the epidemic period. fifteen of the analysed strains further subgroup in y h branch. additionally, mutation i v was identified in two strains. for the remaining gene segments available for the six analysed strains, the observations include: (i) no previously described virulence markers in pb , pb -f , and ns were detected; (ii) pb -f protein is present in the truncated form of amino acids; (iii) the presence of mutations i v and l q in ns and v i in np; (iv) the described association of mutation i v in ns and v i in np genes with viral fitness. phenotypic evaluation of nais susceptibility revealed the existence of three minor and two major outliers to oseltamivir ( figure ). the two minor outliers exhibited a reduction of approximately twofold in the susceptibility to this antiviral drug, comparing to the baseline level, while the reduction exhibited by the two major outliers was of approximately three-and fourfold. regarding zanamivir, two minor outliers were identified with a reduction of approximately twofold in the susceptibility, compared to the baseline level. these two minor outliers (a ⁄ portugal ⁄ ⁄ and a ⁄ portugal ⁄ ⁄ ) correspond to the two major outliers identified for oseltamivir. genetic analysis revealed the presence of the mutation i v in the na sequence of these two strains. the contribution of this mutation for the profile of reduced susceptibility identified for both nais is not known, but a mutation in the same na position (i r) has been referred to as being associated with a reduction in nais susceptibility. full genome sequence analysis of these strains shows that both strains also present the v i mutation in pb gene. however, no association of this mutation with antiviral drug susceptibility is referred in the literature. concerning genetic evaluation of susceptibility to amantadine, all analysed strains present a serine in position , which is a molecular marker of resistance to m inhibitors. these preliminary results allow us to discuss several points. however, the additional data that is being obtained through this ongoing study will be essential for a more complete analysis. for example, more information is needed to determine if the mutations found alter the biology and the fitness of the virus or if there are associated with an increased prevalence of the virus. the majority of the mutations identified in ha subunit have been detected in a(h n ) strains distributed throughout the epidemic curve, not evidencing a specific evolutionary trend. this is in agreement with the genetic and antigenic homogeneity that has being described for a(h n ) virus. the occurrence of mutations in the position of the ha subunit of a(h n ) virus have been described. however, more studies are needed to clarify the outcome of these mutations, as for example in patients with severe complications. it could also be relevant to investigate the presence of single and mixed variants in viruses and in clinical specimens and the possibility of these mutations affecting the binding specificity. regarding the susceptibility of a(h n ) pandemic viruses to antiviral drugs, all analysed strains were found to be resistant to amantadine. this resistant profile was not unexpected since the mp gene from this new variant had originated in the eurasian swine lineage, which is characterised by being resistant to this antiviral drug. the majority of the a(h n ) strains analysed revealed to be susceptible to both nais, with only five strains exhibiting a profile of reduced susceptibility, three to oseltamivir and two to both nais. for these last two, the presence of the i v mutation in the na sequence could explain the reduction observed, but a more complete analysis is needed to confirm this. the french national pandemic plan includes an early containment phase followed by a limitation phase. the efficacy of such a plan depends on pre-existing surveillance and laboratory networks. the grog community surveillance network and the hospital lab networks organized by the two french nics carried out the virological monitor- the efficacy of such plan depends on pre-existing influenza surveillance and laboratory networks. in france, the community surveillance is carried through the grog surveillance network. in addition, surveillance is also carried out in hospitals by the renal network. this renal network is divided in two sub-networks: the so-called h -labs network, activated during the containment phase and the extended renal lab network activated in the limitation phase. the h -labs have bsl- facilities that can be used for diagnosis purposes. as part of the national influenza surveillance system led by the french institute for public health surveillance (invs), the grog community surveillance network and the lab networks linked to the two french nics carried out the virological monitoring of the a(h n ) pandemic from the early containment phase up until the end of the pandemic phase. during the containment phase, all suspected cases were hospitalized and declared to invs. each patient was tested on the same day by specific virological diagnosis. hospital admission was not mandatory during the limitation phase, (i) the clustered cases were monitored to study transmission chains, and (ii) the circulation of the virus in the community was monitored through grog swabs collected by practitioners. the nics organized the influenza surveillance to fulfill several objectives according to the epidemiological situation. first, rt-pcr tools (influenza a m gene rt-pcr and a(h n ) specific h and n genes rt-pcrs) were developped and distributed to the lab networks on the th of may . from the early phase, the nics and the h -lab network analyzed all the samples collected from hospitalized and community patients. during the early phase of the limitation phase, an increasing number of labs were performing the specific assays. when the pandemic wave started, all hospital labs could do the testing. results were centralised by nic and reported on a weekly basis. in addition, nics carried out the monitoring of antiviral resistance emergence (na pyrosequencing, specific h y rt-pcr, and phenotypic assays), and real-time surveillance of genetic changes involved in virus adaptation (pb ) virulence factors or antigenic variations (ha). this sequencing was carried out by the pf sequencing platform of the institut pasteur. the first imported a(h n ) influenza cases were observed from the th of april . a limited number of cases have been reported in may. local transmission could be detected end of may. clusters were observed in schools in june and in summer camps during summer. as opposed to the epidemiology of the a(h n ) virus in other european countries, no summer wave was observed in france. only a limited number of sporadic cases were reported up until october. early september, a significant number of cases presenting with influenza-like illness was reported (figure ). the virological investigation of these cases showed high prevalence of rhinovirus infection. this circulation of rhinovirus was a counfounding factor of the pandemic. the pandemic wave lasted weeks between mid-october and the end of december (week to week , figure ). the pandemic wave started week - in the ile-de-france area, and only week - in the rest of france. the peak was recorded week ( figure ). the impact of the pandemic was mainly observed in the - years group of age. overall, severe cases have been admitted to the hospital, and deaths have been recorded by the end of the pandemic wave. the major impact was observed in the - years group of age ( % of deaths recorded). amongst the severe cases and the deceased cases, % and % of cases had no risk factor, respectively. these specimens, were positives for h n , representing ae % of total influenza virus detections. only nine brisbane-like h n , brisbane-like h n , and eight b viruses have been detected in the same period of time. the weekly positive rate ranged from % to %. phylogenetic and antigenic analyses of the viruses collected during the pandemic wave did not show any emerging genetic or antigenic variants (figure a,b) . eight patients, all among cases presenting with severe illness, were infected by a virus harbouring the d g mutation in the ha. amongst the virus tested for antiviral susceptibility or screened for the h y mutation by or specific rt-pcr, only oseltamivir-resistant viruses related to the na h y mutation have been detected. one of these cases also had an i r mutation associated to a reduced sensitivity to zanamivir. all but one resistant virus were detected in treated immunocompromised patients. overall, eight patients presented a virus with the d g mutation in the ha. all these patients had a severe infection; one of these had also a h y mutation in the na asociated to oseltamivir resistance. the pandemic started by the end of april . although the first cases recorded were as early as the th of april, the epidemic wave associated with a widespread spread of the virus was only recorded in october. the french population did not have to face a summer wave, as observed in north america and in numerous european countries. , it is difficult to speculate the reasons for the lack of summer wave; the specimens collected were negative for influenza. moreover, during september, it was anticipated that school openings would be the trigger for the beginning of the pandemic wave. as a matter of fact, a significant increase of influenza-like syndromes were observed at that time, but the virological investigation carried out by the laboratories showed thta is was related to a very large epidemic of rhinovirus. the epidemic circulation of other respiratory viruses can be counfounding factors for the surveillance of the influenza epidemic clinical when the survellance is only based on collection of clinical information. the starting of the pandemic wave was heterogeneous in france. the ilede-france region (paris and its suburbean area), where the population is dense, experienced an early start as compared to the rest of france. however, once the pandemic started in the rest of the county, the epidemic curves were quite similar. the peak was reached at identical times, although it may have been delayed in some remote places in france. overall, we estimate that % of the french population consulted for an ili presentation. the impact was mainly observed in the - years groupe of. however, this age groupe represented only a limited number of severe cases and deaths. on the other hand, the - years groupe of age, where the prevalence was not high, was the age group where the majority of severe cases and deaths was recorded ( % and %, respectively). this data is consistent with the observational data reported by numerous other countries. according to the profile of hospitalized cases, a(h n ) was more aggressive than seasonal viruses. the number of admission to the hospital was ten-fold that observed during a normal influenza epidemic. even if the mortality was limited ( cases), the age distribution of the deceased patients was different as compared to seasonal influenza ( % mortality in < years of age). the lack of recordeable excess mortality has been interpreted to be the consequence of a very mild pandemic, milder than some seasonal epidemics. however, the median age of the fatal cases was much younger than those observed during the seasonal flu, leading to a mis-interpretation of the real impact of the pandemic. when the impact is measurered in loss of years of life, the impact of this pandemic is larger than seen with seasonal influenza, and is quite comparable to these of the two last pandemics. the pandemic preparadness of numerous countries, the develoment of new intensive care techniques and equipment, and the large use of antivirals have reduced the overall impact of this pandemic. these are new factors that should be taken into account when evaluating the real impact of the h n virus. the virological monitoring of the pandemic was achieved by the community-based and hospital-based sea- sonal influenza networks, reminding the importance of maintining such networks. the diagnosis of influenza in most of the patients was carried out by molecular techniques. it has been clearly stated from the beginning of the pandemic that near-patient tests were lacking of susceptibility and could not be used for patient management. the distribution of a set of validated and comprehensive techniques by the two nic was very helpfull for the monitoring of the pandemic and the patients. however, this diagnostic procedure change should not preclude maintaining virus isolation that is necessary for whole genome analysis, monitoring of antigenic changes, and phenotypic testing for antiviral testing. some of the mutants that have been recorded, including viruses with antiviral resistance phenotype or genotype, could be analysed from grown virus strains. it is striking that despite a large antiviral usage, only a limited number of isolates had mutations associated to resistance. however, the frequent isolation of such resistant virus was observed in immunocompromised patients that presented severe infections and long virus shedding. the impact of the pandemic is still under evaluation. sero-epidemiological analysis will be performed to asses for the real attack rate of the pandemic virus. as in other countries, it has been recorded that asymptomatic infections could be observed frequently. it is quite unlikely that the impact of the pandemic was reduced by the vaccination campaign, although this vaccination started on the th of november, just when the pandemic started in france. it is estimated that millions received the vaccination. pandemic strains of the influenza virus sporadically emerge, deviating from the regular endemic strains of seasonal influenza. in april , a novel pandemic influenza virus a ⁄ h n emerged, swiftly spreading across the world. immediately, domestic and international public health agencies were forced to develop containment and mitiga-tion strategies in response to the pandemic. however, the dynamics and transmission patterns of this novel virus are yet to be fully understood. simultaneously, seasonal strains of influenza (a ⁄ h n , a ⁄ h n , and b) continued to circulate in many nations. both pandemic and seasonal variants of influenza are responsible for significant morbidity and mortality. to characterize the dynamics of this disease and the variation within strains, a more detailed understanding of the patterns in viral shedding during natural infection is required. the majority of data on the patterns of viral shedding during influenza infection are a result of volunteer challenge studies. in these studies, volunteers are commonly screened for pre-existing immunity against the challenge strain and are of a certain demographic and age. information on the patterns of viral shedding in natural influenza infections, pandemic or seasonal, is limited but should provide greater generalizability. we describe the trends of viral shedding and clinical illness in community acquired cases of pandemic and seasonal strains of influenza. in , a community-based study was conducted to analyse the effectiveness of non-pharmaceutical interventions to prevent the spread of influenza in households. in , a similar community-based study was initiated to collect comparative data from individuals infected with seasonal and pandemic influenza. both studies were conducted with very similar protocols, involving households in total. the specimens and symptom data required for this study all arise from secondary infections ascertained in these two community-based studies. the recruitment process in both studies was essentially identical. index cases were first recruited from their healthcare provider if they presented with influenza-like illness (ili). this individual would be included in the follow-up if he ⁄ she tested positive for influenza virus infection by rapid antigen test (quickvue) and was the first person in his ⁄ her household that showed signs of ili in the previous weeks. follow-up consisted of three home visits that spanned approximately - days. at each home visit, nasal and throat swab (nts) specimens were collected from all household members, regardless of the presence or absence of symptoms. symptoms were recorded in daily symptom diaries provided for every household member, and digital thermometers were provided to record daily tympanic temperature. the symptoms recorded were fever ‡ ae °c, headache, myalgia, cough, sore throat, runny nose, and phlegm. influenza virus infection and subtype was identified by reverse transcription polymerase chain reaction (rt-pcr) on the nts specimens. viral shedding was quantified from the same specimens by rt-pcr to determine viral loads, as well as by quantitative viral dilutions to determine median tissue culture infectious dose (tcid ). the details concerning laboratory methods have been described in a previous study. all analyses in this study focus exclusively on secondary cases; these are household contacts of recruited index cases who acquire influenza virus infection following the initial home visit. index cases generally presented with a certain threshold of illness severity requiring medical attention, whereas infections among household contacts can vary from asymptomatic to severe representing naturally acquired influenza infections. these secondary cases must be negative for influenza for their first nts specimen, and subsequently tested positive. we analysed mean viral loads measured by rt-pcr and quantitative culture by plotting by day since acute respiratory illness (ari) onset according to strain of influenza (pandemic a ⁄ h n , seasonal a ⁄ h n , seasonal a ⁄ h n , and seasonal b). ari is the reference time point, because the day of infection is unknown and is defined as the presence of ‡ of the symptoms mentioned above. average symptom scores were also plotted according to ari onset and grouped into upper respiratory symptoms (sore throat and runny nose), lower respiratory symptoms (cough and phlegm), and systemic signs and symptoms (fever ‡ ae °c, headache, and myalgia). mean daily tympanic temperatures were also plotted since date of ari onset and according to strain of influenza virus. all analyses were conducted using r software (version . . ; r development core team). a total of households and individuals were followed-up in the two studies. of household con-tacts tested by rt-pcr, were found to be influenza positive. among these influenza infections, ( ae %) were asymptomatic (rt-pcr positive plus symptoms recorded), were subclinical (rt-pcr positive plus symptom recorded), and presented with an onset of ari during the follow-up period. from the cases with ari onset, seven pandemic a ⁄ h n , seasonal a ⁄ h n , seasonal a ⁄ h n , and seasonal b influenza virus infections were identified. the age distribution among secondary cases was observed to be largely comparable across the four strains of interest (table ). there were a lower proportion of males who acquired pandemic a ⁄ h n compared to the seasonal strains of the virus. cough was the most commonly reported symptoms during follow-up in cases of pandemic a ⁄ h n and seasonal b, whereas runny nose was most common in seasonal a ⁄ h n and a ⁄ h n cases. cumulatively, fever ( ‡ ae °c) was reported in approximately half ( %) of the secondary cases. patterns of viral shedding were analysed in a subset of influenza positive individuals who recorded an onset of ari in their symptoms diaries (figure ). household contacts that were asymptomatic, subclinical, or did not have an ari onset were excluded from the analysis. viral shedding in all three influenza a strains were recorded to occur on the day of ari onset or day post-ari onset. follow- ing the peak, measured levels of viral shedding declined steadily to undetectable levels over - days. the trend of viral shedding in influenza b infected individuals rose days before ari onset, fluctuated for around days before eventually resolving. the patterns of viral shedding over time measured by quantitative viral culture were generally similar to the patterns measured by rt-pcr. the patterns of symptoms and signs were comparable in the four strains of influenza included in this study, peaking on the day or day post-ari onset, and gradually declining over a period of - days. in all strains, systemic symptoms and signs were observed to resolved faster than upper and lower respiratory symptoms. the trend of tympanic temperature in each influenza strain was comparable to the respective symptom pattern. patterns of viral shedding observed in influenza a strain infections (pandemic a ⁄ h n , seasonal a ⁄ h n , and seasonal a ⁄ h n ) were broadly similar. the pattern differed from the observed pattern of viral shedding in seasonal influenza b infections. the majority of viral shedding in influenza a strains occurred at and near ari onset, whereas there were variable amounts of viral shedding preand post-ari onset for those with influenza b. the biological reason for this difference is yet to be clarified. these differences are consistently observed regardless of laboratory method used to quantify the viral loads. it was observed that viral shedding measured by tcid resolved more quickly than when measured by rt-pcr, suggesting that rt-pcr is more sensitive, but it could be detecting inactivated fragments of rna instead of active virus. the trends observed for the seasonal strains of influenza in this study were similar to those reported in literature. the patterns of symptoms and signs as well as tympanic temperature in the four different strains of interest in this study were found to be comparable. these patterns closely resemble the patterns of viral shedding observed in the influenza a virus strains, but not in the influenza b virus strain. the trends of viral shedding, symptom scores, and tympanic temperature for pandemic a ⁄ h n were similar to trends observed for seasonal a ⁄ h n and seasonal a ⁄ h n infections, suggesting that the dynamics of these viruses are largely the same. the clinical course of infection with pandemic a ⁄ h n influenza virus appeared to be similar to the seasonal b influenza virus, but the patterns of viral shedding over time diverges. in general, our results suggest that the dynamics of the pandemic a ⁄ h n virus were similar to the seasonal a ⁄ h n and a ⁄ h n viruses, and clinically similar to the seasonal b virus. this study faced sample size limitations; very few cases of pandemic a ⁄ h n were detected and the secondary attack rate in general was low, though a total of households were followed up. this lack of power led to the inability to analyse the differences between adult and children and other characteristics that could be correlated with amount of viral shedding. there are also biases that must be factored in during recruitment. the eligibility criteria of only healthy households could select for households with higher innate immunity. on the other hand, recruitment at health care providers can be biased towards index cases that had more severe illness that required medical attention. the strength of the study is the broad generalizability of the results due to the strict classification of secondary cases. the infections reported in this study were all community-based and should represent true natural infections. pandemic potency of the influenza virus is largely determined by its transmissibility. the first objective of this study was to model the transmission of influenza h n and h n viruses. at present, vaccination with laiv has been used as a widespread, effective public health measure for influenza prophylaxis. some unsubstantiated concerns have been raised about a potential possibility of reassortment of circulating influenza viruses with laiv viruses following vaccination with laiv. thus, another objective of this study was to assess the probability of pig-to-pig transmission of cold-adapted viruses and their potential reassortment with wt influenza strains. female albino guinea pigs weighing - g were inoculated intranasally with eid of virus without anaesthesia. transmission studies were then performed hours after inoculation. inoculated animals were housed at % relative humidity and °c in the same cage with noninfected guinea pigs or in cages placed m away from non-infected pigs. virus replication was determined by virus isolation in hen eggs and by pcr. sera were collected at and days post inoculation. seroconversions were assessed by routine hai test. genome composition of reassortants was monitored by rflp analysis. capacity of the viruses to grow at optimum, low, and elevated temperatures (ca ⁄ ts phenotype) was evaluated, and virus growth properties were observed following virus titration in hen eggs. when infected pigs were co-caged with non-infected (naïve) individuals, vn , indo ⁄ , a ⁄ california ⁄ ⁄ , and nibrg- were isolated in %, % ae %, and % of contact animals, respectively. serological confirmation of virus transmission was higher than virological data ( %, %, %, and %, respectively). in addition, it was shown that when pigs inoculated with a ⁄ california ⁄ ⁄ were co-caged with animals inoculated with nibrg- , they got infected with both viruses ( table ) . the ability of direct transmission of cold-adapted viruses was also investigated. data show that the a ⁄ ⁄ california ⁄ ⁄ laiv candidate was detected in the upper respiratory tract of ae % vaccinated pigs. the mdv was identified in % of infected animals. however, neither group of contact pigs, co-housed with the vaccinate pigs, had evidence of infection with cold-adapted viruses. in addition, none of the contact pigs had any evidence of seroconversion to the coldadapted viruses as determined by hai assay. it was also most interesting to note that pig-to-pig transmission of the highly transmittable nibrg- reassortant virus was not seen when pigs, vaccinated with mdv, were co-caged with animals infected with nibrg- virus (table ) . this strongly implies a form of interference or protection from transmissibility that was provided by the cold-adapted virus. the results show that nibrg- and indo ⁄ viruses were able to spread between cages over the m distance ( % and % naïve animals were successfully infected, respectively). a ⁄ california ⁄ ⁄ influenza and vn viruses did not transmit between infected and non-infected guinea pigs housed in separated cages (table ) . pigs with confirmed a ⁄ california ⁄ ⁄ virus replication were also infected with nibrg- virus if h n -and h n -infected animals were separated by a space. thus, influenza virus transmission from h n -to h n -infected pigs has been shown, but the reverse pattern did not occur. transmission of nibrg- or a ⁄ california ⁄ ⁄ viruses was not observed when contact pigs were first vaccinated with the mdv and housed at a m distance ( table ) . it was also shown that efficiency of transmission of nibrg- was much higher than of other studied h n viruses; it can be transmitted between naïve guinea pigs separated from infected animals at a distance of - m (data not shown). five reassortants were isolated from animals which were infected with a ⁄ california ⁄ ⁄ virus and co-caged with pigs inoculated with nibrg- . two reassortants possessed different combinations of pr , nibrg- , and a ⁄ california ⁄ ⁄ genes and demonstrated the non-ca ⁄ non-ts phenotype typical of wt viruses. unexpectedly, two other reassortants inherited ha gene from nibrg- , na gene from a ⁄ california ⁄ ⁄ , and other genes from pr became ca and ts. : non-ts reassortant inherited pa gene from pr and seven other genes from a ⁄ california ⁄ ⁄ , gained ca properties. in spite of aforesaid experimental data, we cannot exclude the theoretical possibility of simultaneous infection of human host with cold-adapted and wt influenza viruses. to better understand possible consequences of such a reassortment event, we co-infected guinea pigs with a mixture of mdv and nibrg- viruses. nasal washes were collected and cloned by limited dilutions in hen eggs in the presence or absence of immune serum to the mdv. cloning of nasal washes without antiserum led to isolation of over clones, which were all identical to the mdv (data not shown). when nasal washes were cloned in the presence of antiserum, only nine clones were isolated. genome composition analysis showed that all isolates were triple reassortants, which had inherited pb and na genes from mdv, pa gene from pr , and ha gene from nibrg- . the origin of the other gene segments (pb , np, m, ns) in the genome of guinea pig-derived reassortants varied. reassuringly, all reassortants generated in vivo had the phenotype typical of the mdv. the severity of influenza outbreaks is partly determined by efficient spreading of the causative virus strain between human hosts. however, little is known about mechanisms underlying influenza virus transmission in humans. guinea pigs have been shown to be a suitable model for influenza transmission studies. our in vivo study showed that influenza a viruses vary in their transmissibility. nib-rg- and indo ⁄ viruses were able to transmit to naïve animals caged distantly from infected animals. in contrast, cold-adapted viruses, the same as those used for licensed laivs, showed no signs of transmission from one guinea pig to another. our study also provided evidence of a lower level of transmissibility of the novel pandemic h n virus compared to the nibrg- and indo ⁄ h n strains evaluated. benefits of vaccination with laiv to aid in the control of influenza outbreaks are acknowledged by the who. in our study, the mdv inoculated into guinea pigs appeared to interfere with and even offer protection from transmission of the highly transmissible nibrg- virus. the ability to immunize with the laiv and subsequently block the spread of a homologous h n subtype and a heterologous h n subtype influenza virus between guinea pigs has been shown. interference between cold-adapted and wildtype influenza virus infection was the most likely explanation for the data observed in our study. the mdv inoculated into guinea pigs might in some way interfere with transmission of highly transmissible influenza viruses. it is believed by some that widespread use of laiv could increase the potential risk of reassortment of the vaccine strain with circulating influenza viruses immediately following vaccination. however, it was shown that any such potential reassortments would most likely lead to yet attenuated viruses. our in vivo studies have shown that introduction of mdv genes into the genome of nib-rg- virus led to the generation of triple reassortants inherited pb and na genes of mdv and ha gene of h n virus. all isolates possessed phenotypical markers associated with attenuation of mdv. our data suggest that even if a reassortment event of such rare occurrence between a laiv strain and a circulating virus were to occur, it would most likely lead to a reassortant that would retain highly attenuated phenotypic properties of the vaccine strain. our data strongly support the safety of laivs, especially those developed against highly transmissible h n and h n pandemic influenza viruses. this information builds upon databases that have clearly shown the low likelihood of transmitting an laiv, as well as the high likelihood of any field reassortment of laiv with a circulating influenza virus to retain important properties of the cold-adapted, temperature-sensitive vaccine master composition. very interestingly, we also present data that show the potential of a laiv to prevent the transmission of highly infectious influenza viruses, perhaps identifying a broader role for laiv in the overall scheme of influenza virus prophylactic use. background: schlieren imaging is a non-invasive, real-time airflow visualization technique that relies on differences in air temperatures (and the resulting changes in the refractive index) to allow exhaled human airflows to be seen clearly against the background of more-stationary, ambient air. recently, this technique, well-known to engineers, has been applied to better understand and characterize airflow behaviors associated with everyday, as well as healthcarerelated, human respiratory activities. materials and methods: as a surrogate marker for the behavior of airborne infectious agents, schlieren imaging was used to visualize the airflow patterns produced by adult human volunteers of different ages while coughing with and without the wearing of standard surgical and n masks. results: the cough plumes were generally similar in shape and range for all the adult volunteers used in this study. although both the surgical and n masks decelerated and blocked some of the forward momentum of the coughed airflows, much of the cough plume was redirected and escaped around the top, bottom, and side edges of the masks to merge with the volunteer's natural, verticallymoving thermal plume. conclusions: schlieren imaging is a safe technique for visualizing exhaled airflows from human volunteers without the need for potentially-irritant or toxic particle tracers. findings from these schlieren imaging experiments will assist the development of more effective aerosol infection control guidelines in healthcare premises where patients infected with potentially airborne infectious agents (e.g., influenza and tuberculosis) are present. these infectious agents may be transmitted to healthcare workers, other patients, and their visitors by way of exhaled airflows. with the recent influenza pandemic , and the ongoing concerns about human cases of avian influenza h n infections, there is now a very real concern about the potential for the aerosol transmission of respiratory pathogens. such concerns amongst staff and patients in healthcare environments have led to a greater emphasis on the understanding and control of infectious airflows. , previous visualization techniques have used potentially-toxic or irritant gas or particulate tracers with hazardous laser light sources that have precluded the use of human volunteers as subjects. instead, various forms of lung models that simulate human respiratory patterns with such particulate tracers have been used. , schlieren imaging is a technique familiar to engineers and offers a non-invasive (i.e., no tracer required) airflow visualization method that depends only on differences in the refractive index of the warmer, human-exhaled air and the cooler ambient air. the use of a simple incandescent or light-emitting diode (i.e., non-laser) light source is safe and allows human volunteers to be used as experimental subjects, where their exhaled airflows are then observed using a large, precise spherical or parabolic telescopic mirror and a camera, and are recorded for later analysis and presentation. [ ] [ ] [ ] the analysis of these patterns of 'real-life' human airflows will be useful in optimizing aerosol infection control guidelines, which aim to reduce the transmission of airborne infectious agents to other healthcare personnel, patients, or their visitors. the images and analysis presented here have all been obtained from the large m diameter parabolic mirror (figure ) situated at the gas dynamics laboratory of penn state (directed by gary s. settles). this large schlie-ren imaging system has been in use for over years to obtain high quality schlieren images for various engineering applications. it has only recently been applied to clinically-relevant imaging. the objective of this paper is to augment and expand upon the details of the methods and results presented in an earlier study using this same schlieren imaging system. the aim of this series of studies is to visualize and capture a series of airflow images produced by coughing from adult human volunteers of different ages ( - years old). these included males (three of years, one of years of age) and females (one of years, one of - years, and one of - years of age). each volunteer was tested with and without wearing either a standard surgical mask or n mask. more specifically, the aim was to visualize the extent and direction of leakage around the mask whilst each subject was coughing. penn state institutional approval for experiments involving human subjects was also obtained. each volunteer was asked to stand approximately m in front of the schlieren mirror, facing across the surface of the mirror on one side, and to cough several times as the real-time, color image and video footage was recorded by the operator (using a nikon d camera; nikon inc. melville, ny, usa). this process was repeated whilst each volunteer was wearing a standard surgical mask then an n mask (supplied by mÔ, st paul, mn, usa). some of the schlieren images obtained from some of these volunteers have been published previously: for a -year old male, the year-old female and a -year old male, and the - year-old female. this article completes this series of schlieren images obtained from these experiments by including the images recorded for the older, year-old man. generally, it was found that the shape of the cough plumes (shown in the figure as darker shadows emanating from the subject's mouth) produced by adult humans of different ages was relatively similar. cough plumes are roughly conical in shape and very turbulent, usually passing beyond the extent of the m mirror (figure a) . a previous detailed study of one of these images measured a maximum airflow velocity of m ⁄ second for an adult cough. similarly, the effects of wearing surgical and n masks can be generalized across different ages. wearing a surgical mask allows leakage of the coughed air from the sides, top, and bottom of the mask ( figure b ). there is also some leakage through the mask, as indicated by the darker patches of air directly in front of the mask ( figure b, c) . the useful effect of the mask appears to be a deceleration and redirection of this coughed (and potentially infectious) air into the natural, upward-rising human thermal plume, which captures it and carries it upwards where it is diluted and less likely to transmit infection to others. the effects of the n mask are similar (i.e., deceleration and redirection), yet due to its tighter (mask-fitted) face seal, more of the coughed air appears to penetrate the front of the mask ( figure c ). this penetrating air is, however, also decelerated sufficiently to allow the wearer's natural thermal plume to carry it upwards. , discussion from these series of schlieren images presented in this and other related studies, [ ] [ ] [ ] it is clear that schlieren imaging offers a safe, non-invasive, real-time technique to visualize human exhaled airflows for all age groups. it is apparent that, at least where airflow patterns are an acceptable surrogate marker for airborne transmission risks, there are beneficial effects of wearing either type of mask, even when the mask fit is relatively poor. this is often the case when n -style masks are purchased and used by the general public -in contrast to the situation with healthcare workers, who are often accurately fit-tested for this type of mask. the immediate significance of this can be seen when masks are bought by parents for their children. often, these will not be of pediatric size and the mask-fit will be loose. children are well-known to be major sources of infection in the community because of their relatively poor immunity to many types of infectious agents due to their young age and, therefore, limited past-exposure history. these images allow infection control teams to literally see how far and how fast potentially-infectious human exhaled airflows can travel from an individual. this may have significant implications for guidance on the wearing of masks for infected staff and patients, on ward bed-spacing, as well as for the types of masks to be used in different situations. the important practical potential lies in the non-intrusive visualization of airflows associated with human volunteers, to assist in heightening the awareness amongst healthcare workers of the risks and potential for the airborne transmission of infectious agents, as well as the development of more effective aerosol infection control policies. schlieren images can be analysed more quantitatively, e.g., with the 'schlieren-piv' technique, , though this additional quantitative data is probably more of research interest than being of immediate practical use to everyday hospital infection control teams. these are the subtypes that we have studied. clearly, the question arises as to whether the changes in antigenicity are coupled with changes in germicide susceptibility. we have employed a modified log-reduction method in a cell culture system employing mdck cells in serum-free ex-cellÔ medium supplemented with trypsin. microscopic examination of cpe was the marker for infectivity together with plaque assay. we confirmed antiviral potency by using specific subtype influenza identification subtype technology, quidel quickvue Ò influenza a + b test. the log inactivation and percent inactivation by bac after a second contact time for the h , h , and h pandemic strains are as follows: a ⁄ swine ⁄ iowa ⁄ ⁄ h n , ae log ⁄ ae %; a ⁄ swine ⁄ cal ⁄ h n , ae logs ⁄ ae %; a ⁄ j ⁄ ⁄ h n , logs ⁄ ae %; and a ⁄ hong kong ⁄ h n , ae logs ⁄ ae % (table ). comparable results of antiviral efficacy are obtained with the tcid and plaque assays against all subtypes studied. when performing the plaque assay the sensitivity of virus recovery was better in the vessel with a larger surface area and overall recovery was in agreement with the potency determined by tcid assay. in our plaque assay, we inoculated a ⁄ hong kong ⁄ ⁄ virus dilutions into two different vessels with hours adsorption time: -well plate and t- flask, ml inoculum per replicate. virus titers obtained were: ae · pfu ⁄ ml from -well plate and ae · pfu ⁄ ml from t- flask ( table ). the discrepancy on virus potency can possibly be explained as: the binding of virus to host cell occurs only when virus gets a chance to interact with the cell on the monolayer during adsorption time. the percentage of virus population in the inoculum that has the opportunity to bind to the cell mainly depends on the surface area where this interaction takes place. therefore, in our experiment the plaque assay in the t- flask gave higher virus recovery ae versus ae · pfu ⁄ ml. the increased virus recovery can translate into better sensitivity of the test system for disinfectant and antiviral agents. the potency of the virus used in this study was determined by tcid was · tcid ⁄ ml. rapid diagnostic testing for influenza (quickvue Ò influenza a + b test, quidel) for aj versus bac was studied. the presence of influenza viral nucleoprotein a determined by quickvue kit correlated % with the viral infection based on by cpe in viral culture. interestingly, the inactivation of viral nucleoprotein was able to be revealed with diagnostic kit in the dilutions of virus ⁄ bac reaction mixture, which possessed prominent cytotoxic effect for the host cells in viral culture system. this type of molecular testing method is useful for interpreting antiviral efficacy against a background of cytotoxicity. these experiments are intended for the sponsor to substantiate to us fda that their antiviral substances are safe and effective. the data shows that the three hemagglutinin subtypes were highly susceptible to the quaternary ammonium compound in the short term in vitro experiment. the appearance of novel subtypes in the future can be met with the assurance that disinfectant and ⁄ or antiseptic resistance will be unlikely. certainly, from the above data, although genetic reassortment of human and swine viruses may modulate influenza pathogenesis and limit existing vaccine benefit, it is not likely be a factor in control of viruses on environmental surfaces by benzalkonium-type disinfectant ⁄ cleaning agents in community or health care environments. table . comparison of viral titer obtained in different vessels using quantal tcid and plaque assay methods plaque assay tcid assay t- ( cm ) -well plate ( cm ) tcid ⁄ ml tcid ⁄ ml ae · pfu ⁄ ml ae · pfu ⁄ ml · ae · options for the control of influenza vii outbreak influenza in aged care facilities (acfs) is associated with an increased risk of poor health outcomes among residents, including death. in this paper we share our experience of managing an outbreak of viral respiratory infection in an acf very early in the influenza pandemic and also describe some of the emerging issues relating to crossreacting antibodies to the pandemic (h n ) influenza virus in the very elderly. the outbreak investigation was conducted as part of an urgent public health intervention initiated by the new south wales (nsw) department of health during the early stages of the first southern hemisphere wave of the pandemic. nose and throat swabs for nucleic acid testing (nat) plus acute and convalescent serum samples ( weeks apart) were collected from all the residents of an acf where an influenza-like illness (ili) outbreak occurred. the investigation revealed dual outbreaks of pandemic (h n ) influenza and rhinovirus infection. out of residents, three had laboratory confirmed influenza [two with pandemic (h n ) ], and had rhinovirus infection on nat. testing of acute sera collected from every subject found elevated ( ‡ : ) pandemic (h n ) hai antibody in % ( ⁄ ) subjects aged years or more (born before and median age years; geometric mean titre-gmt ae ) compared with none of the residents aged under years (born after and median age years; gmt ae , p = ae ). the acf was closed to visi-tors for days. the symptomatic residents received treatment-dose oseltamivir, and all other residents were given oseltamivir prophylaxis. more than one virus may be circulating in an acf with an ili outbreak at any one time in winter. a significant proportion of elderly residents had pre-existing cross reacting antibody to the pandemic (h n ) , which may explain the minimal clinical impact of pandemic (h n ) in this elderly population. influenza is one of the leading causes of infectious death in elderly people, principally due to co-morbidities and declining immune competence with age. it is the most important agent in outbreaks of respiratory illness. influenza in aged care facilities (acfs) is associated with an increased risk of poor health outcomes among residents, including death. the clinical presentation of influenza in residents of acfs can be subtle, with a blunted febrile response and a non-specific decline in mental and functional status. residents commonly have underlying diseases that can be exacerbated by influenza infection, and in addition, they are at higher risk of serious influenza-related complications than community dwelling elderly people. people aged over years are also at higher risk of influenza-related death, and more than % of annual influenza-related mortality is usually confined to this high risk group. in australia, influenza and pneumonia have sub-stantial health impacts; recorded as being the underlying causes of death for persons in . since the world health organization declared an influenza pandemic in june , australia has suffered one of the highest rates of confirmed infection during the first southern hemisphere wave. by late october there were reported deaths due to pandemic influenza in australia, and to date there have been about deaths reported worldwide. although disproportionately far fewer elderly people developed clinical influenza during the current pandemic than occurs with seasonal influenza, their case-fatality rate remained substantial. early in the pandemic (june ), we investigated a suspected pandemic influenza outbreak in a rural acf in the state of nsw, australia. the epidemiology (including virulence and clinical outcome in the elderly) of the pandemic (h n ) virus was mostly unknown at the time of investigation, and as time passed, this investigation provided clarity on some important issues of the influenza epidemiology in the elderly population. in this paper we share our experience of managing a dual outbreak of viral respiratory infections early in the pandemic, and also describe some of the emerging issues relating to the cross-reacting antibodies to pandemic influenza in the very elderly. the outbreak investigation was conducted as part of urgent public health intervention initiated by the nsw department of heath in conjunction with the local public health unit, the national centre for immunisation research and surveillance (ncirs), and the institute of clinical pathology and medical research (a who national influenza centre). to determine the extent and cause of the outbreak, a public health research doctor (gk) was dispatched from sydney over a weekend to assist with outbreak investigation and control. on june th , the greater southern public health unit surveillance officer (bd) received a report of a possible pandemic (h n ) outbreak in a local acf. on investigation, it was discovered that days earlier a year old female resident had become generally unwell, but without specific symptoms of influenza like illness (ili). soon after, nine of the co-residents (but no staff) had developed symptoms suggestive of influenza. one other resident had returned from a melbourne (victoria) hospital (where pandemic (h n ) was known to be circulating) the previous week after surgery, but did not have ili symptoms. on june th, the symptomatic residents had nasal swabs taken by the local doctor for influenza [including pandemic (h n ) ] nucleic acid testing (nat). there was rising concern due to reports of widespread pandemic (h n ) influenza in a local army camp just over the border in nearby victoria, where pandemic (h n ) influenza was known to be circulating widely. on june th, the year old lady proved nat positive for pandemic (h n ) , but none of the other samples were pandemic (h n ) nat positive. concern arose that there might be an outbreak of pandemic (h n ) in the facility, and that some of the swabs from other residents might be false negatives. between and june, after consent was obtained, directly or through next of kin in demented residents, all submitted to venipuncture for serology, successfully, and the other as yet un-swabbed residents were swabbed. basic demographic data were collected from every resident with clinical information on co-morbidities and current medication use. convalescent blood samples were collected after weeks on th july from of the residents. swabs were sent to icpmr where nat for influenza a [including pandemic (h n ) ] and b was performed. the acute and convalescent serum samples were tested later (in december ), using haemagglutination inhibition assay (hai) to detect pandemic (h n ) antibody. , interventions the acf was closed to visitors from th until th june. treatment of the positive case and the nine symptomatic residents, with twice daily oseltamivir, was begun on saturday june th, and all other residents were started on once daily oseltamivir prophylaxis. the facility manager and local general practitioner (gp) monitored patient health on a daily basis, and none had to stop oseltamivir due to adverse events. one resident with ili who was known to have moderately impaired renal function was given once daily rather than twice daily oseltamivir treatment. the age range of the residents was - years with a median of years. all residents had underlying medical conditions, e.g., chronic cardiac and respiratory diseases ( table ) testing of acute sera collected from every subject found elevated ( ‡ : ) cross-reacting hai antibody to the pandemic (h n ) in % ( ⁄ ) of subjects aged years or more (born before and median age years; geometric mean titre-gmt ae ). however, the hai titre was consistently < : and significantly lower (gmt ae , p = ae ) in the residents aged under years (range - years, median years) (figure ). the index case (nat positive) did not show a significant raise in hai level in convalescence (going from to ). the pandemic (h n ) case that was determined by serology was pandemic (h n ) nat negative. to our surprise, seven of the other asymptomatic residents had rhinovirus detected on extended nat (reported on june th), despite being asymptomatic at time of swabbing and remaining so. the original nine influenza nat negative samples were then tested and three of these were also nat positive for rhinovirus; in total, ten proved nat positive for rhinovirus ( ae %). the serologically confirmed pandemic (h n ) case was also positive for rhinovirus infection. of interest was that only one resident had a documented fever. this investigation illustrates some of the difficulties in managing and investigating possible influenza outbreaks in real time in the context of an influenza pandemic. finding a nat positive case of pandemic (h n ) influenza among many other symptomatic cases raised the possibility (although not the probability) that pandemic (h n ) was the cause of the outbreak. rhinovirus infection, however, was confirmed by nat in ten residents. this outbreak illustrates that more than one virus (in this case and perhaps ) may be circulating in an acf at any one time in winter. in ili outbreaks in acfs, broad laboratory testing is recommended; nat is the most sensitive method of detecting influenza or other viruses in respiratory tract samples. studies have found that the pandemic (h n ) haemagglutinin (ha) gene is more closely related phylogenetically to the h n virus and classical swine influenza a ⁄ h n viruses than more recent seasonal human influenza a ⁄ h n viruses. it is antigenically similar to the h n pandemic virus in terms of the immunodominant antibody response to haemagglutinin. [ ] [ ] [ ] it is likely that individuals alive during the emergence and initial persistence of the pandemic virus would have higher levels of cross-reacting hai antibodies to the pandemic (h n ) , which would contribute towards better clinical protection. in our investigation, % of the residents born before (aged years or above in ) had pre-existing cross-reacting hai antibody to the pandemic (h n ) . in elderly populations, severe illness may be associated with organisms typically considered to be mild, such as rhinovirus. however, studies have shown that nursing home residents may be susceptible to outbreaks of rhinovirus that may cause mild to severe respiratory illness, particularly in those with a history of lung disease. one rhinovirus outbreak in a nursing home in the usa caused fatalities. another outbreak showed residents with underlying lung disease are more likely to have longer infection, require antibiotics, develop bronchospasm, and have difficulty breathing; two residents with underlying lung disease required emergency treatment and one died. a previous influenza outbreak in a nsw aged care facility in caused significant mortality and morbidity. that outbreak resulted in hospital admissions and six deaths. in our investigation we have found that % of the residents had chronic lung disease and % had chronic cardiac conditions both considered as high risk for severe complications of both rhinovirus and influenza infection. however, there were no hospitalisations or deaths in our outbreak investigation. indeed only one resident developed fever, indicating that non-specific signs of illness (such as in our index case) may be the only, or early, indication of an ili. our own experience with managing other ili outbreaks has also taught us that staff of acfs may not be vigilant enough to detect fevers. in this outbreak, the nursing home staff, local gp, public health unit and the outbreak investigation team and supporting laboratory staff acted quickly and in a coordinated way. pre-existing cross-reacting antibody in the very elderly (aged ‡ years) probably helped to limit the spread of the pandemic virus (compared to the circulation of rhinovirus) within the acf. exposure to the pandemic (or a close variant occurring before ) appears to be responsible for a high hai titre in the very elderly, which contributed towards better clinical protection. however, wider testing early on would have alerted us more quickly to the main cause of the outbreak. treatment and prophylactic use of oseltamivir may also have contributed to halting the spread of pandemic (h n ) and also to symptom relief. pandemic (h n ) influenza virus (ah pdm) has spread worldwide since march . in a paper of ah pdm, % of infected individuals have experienced gastrointestinal symptoms such as diarrhea and vomiting, which is higher than that of seasonal influenza. however, little is known whether viable virus shed from stool and replication of viruses are ongoing in the gastrointestinal tract. , viral load and isolation of ah pdm in cell culture in stool samples has been reported. stool specimens were collected from patients suspected to have pandemic (h n ) infection from november through may . virus isolation was conducted in cell culture by using madin-darby canine kidney (mdck) cells and taqman based rt-pcr from % (w ⁄ v) stool suspension in phosphate-buffered saline. taqman based rt-pcr was conducted by using primers, probes, and positive controls provided by niid (national institute of infectious diseases of japan). to confirm presence of ah pdm viral rna, lamp (loop-mediated isothermal amplification) was used as supplemental testing. of patients, one child (case ) submitted one nasal swab and four stool samples, another one nasal swab and two stool samples, and the other one stool sample. informed consent was obtained. strand specific rt-nested pcr was performed for only case by using only one primer at the rt reaction and also assayed neu aca - gal and neu aca - gal binding specificity about isolated strain derived from nasal swab and stool. receptor binding specificity was performed using a solid-phase binding assay with the sialylglycopolymers (poly a-l-glutamic acid backbones containing neu aca - galb - glcnacb-pap or neu aca - galb - glcnacb-pap bond as described. ) nucleotide sequences of the ha gene of ah pdm viruses isolated from stool sample and nasal swab were analysed. in order to exclude the possibility of contamination, the stool samples and nasal swabs were subjected to virus isolation separately. after getting the results on the nucleotide sequence, we also confirmed no strain harboring identical sequence was isolated in our laboratory before and after the day of sample collection. ah pdm viral rna was detected in nine ( %) of the subjects from stool samples. among nine subjects, one case (case no. ) was positive for viral isolation. case , a healthy -year-old girl, experienced fever and abdominal pain, and the others had gastrointestinal symptoms without upper respiratory symptoms. in case , influenza a virus was diagnosed by rapid antigen test on the day of symptom onset. viable ah pdm virus was isolated from the stool sample and nasal swab on the second day from onset using mdck cells (table ). viral load decreased gradually after symptom onset. however, viral shedding was still present days after symptom onset. positive stranded rna was detected days after symptom onset from the stool specimen ( figure ). above two ah pdm strains (isolated from nasal swab and stool specimen) bound exclusively to human type receptor, neu aca - gal. sequence analysis demonstrated that isolated virus from stool samples was identical with that from nasal swabs in comparison of ha gene ( bp). ah pdm influenza virus was isolated from the stool and nasal swab samples in the same patient simultaneously by using mdck cells. our results suggests the detection of viral rna and viable ah pdm influenza virus from stool samples may serve as a potential mode of transmission and has important implications in understanding the context of ah pdm influenza virus. strategies to prevent transmission of influenza include use of respirators. ffp and n respirators are certified to fil-ter at least % of particles ( ae lm in diameter), and many guidelines have recommended that healthcare workers wear respirators in certain healthcare settings to protect against infection from patients with pandemic influenza. [ ] [ ] [ ] we have developed a proprietary acid-polymer formulation to coat a standard ffp respirator with an antiviral layer. we aimed to test this coated respirator for antiviral efficacy against a range of influenza viruses. a series of tests compared the antiviral efficacy of coated and uncoated respirators in conditions designed to simulate real-life exposure to influenza by varying the route of inoculation, contact time, temperature, humidity, moisture, and contaminating substances. we also investigated whether infectious viruses could be transferred from contaminated respirator surfaces to gloves. we tested human, swine, and avian influenza viruses, including influenza a and b viruses. influenza a subtypes were the a ⁄ h n pandemic strain, seasonal h n , h n , h n , h n , and h n . in each test, suspensions of influenza viruses were prepared to - log tcid ⁄ ml in mem. in some tests, organic contaminants (yeast, bsa, and mucin) were added. one set of respirators was maintained at °c and % relative humidity for hours before the viral challenge, and repeatedly sprayed with he-pes buffer to simulate respiratory secretions. for each test, three coated (glaxosmithkline actiprotect) and three uncoated (sperian willson easy fit) ffp respirator samples were inoculated with ae ml of a viral suspension, which was applied with a pipette, sprayed, or aerosolised to create airborne droplets. after minute at room temperature (on a shaker), the respirator samples were assayed for the presence of infectious viruses using standard methods. in one test, after a minute contact time of the respirator with the virus, nitrile gloves were applied with light pressure to the outer surface of inoculated respirator samples and then assayed after minute. samples were put into test medium (mem, supplemented with antibiotics [penicillin, gentamycin, or streptomycin] and amphotericin b or l-glutamine). the supernatants were vortexed, extracted, and used to prepare serial -fold dilutions in mem. each dilution was used to inoculate four wells of rmk cells in a multi-well plate, and these cultures were incubated and scored over days for cytopathic effects, cytotoxicity, and viability. (some tests substituted mdck cells; others used inoculated embryonated chick eggs.) all tests included negative cell controls, cytotoxicity controls, and neutralisation controls. the spearman-karber formula was used to calculate viral loads as tcid or eid . antiviral efficacy was calculated from the difference between the geometric mean loads of influenza virus on the coated and uncoated respirators after minute of exposure. the viral loads applied to respirators in these experiments ranged from ae to ae log tcid , and were therefore high in comparison with respiratory secretions from infected patients at the peak of influenza symptoms (range - log tcid ). tables - show that the average viral loads detected on uncoated ffp respirator samples remained high in all conditions tested, ranging from ae to ae log tcid (or ae - ae log eid ). in contrast, the average viral load on coated respirators after minute of exposure ranged from below the limits of detection to £ ae log tcid ( ae log eid ). therefore, the relative antiviral efficacy of the coating ranged from ‡ ae to ae log . table shows that the relative antiviral efficacy of the coated mask remained high in simulated-use conditions such as organic contaminants and repeated saturation at high temperature and humidity. in the experiment to test transfer of viruses from respirators, the gloves applied to regular uncoated inoculated respirators had a viral load of ae log eid (table ) . by contrast, no viruses were detected on either the coated respirators or the gloves applied to them. the relative reduction in contamination was therefore ‡ ae log . ‡ ae log viral load with organic contaminants* ae ae ae log viral load after heat, moisture, and simulated secretions** ae ae ae log viral load transferred to glove** ae £ ae ‡ ae log eid *influenza subtype was a ⁄ h n , and strain was vnh n -pr ⁄ cdc-rg. **influenza subtype was a ⁄ h n , and the strain was hong kong ⁄ ⁄ . results are mean log tcid , unless specified otherwise. results are mean log tcid , unless specified otherwise, based on an infectivity assay in triplicate. limits of detection varied. * pandemic strains. **results are mean log eid , based on a haemagglutinin assay in duplicate. options for the control of influenza vii ª blackwell publishing ltd, influenza and other respiratory viruses, (suppl. ), - strategies to prevent transmission of influenza include use of respirators, and many guidelines have recommended that healthcare workers wear respirators in certain healthcare settings for protection against pandemic influenza. - ffp respirators are certified in europe to filter at least % of nacl particles ( ae lm in diameter), and ffp and ffp respirators must filter at least % and % of these particles, respectively. influenza a viruses are typically ae lm, and can be carried in aerosolised droplets smaller than lm in diameter, which can disperse widely, remain airborne for hours, and be inhaled deeply into the respiratory tract. we have developed an acid-polymer formulation to coat the outer layer of a standard ffp respirator, in order to provide antiviral activity on the outer surface. we compared this coated respirator against standard ffp , ffp , and ffp respirators for filtration of aerosolised influenza viruses. the aim was to simulate protection against infectious viruses in droplets released when infected people cough and sneeze, and during aerosol-generating procedures in healthcare settings. the first assay compared three samples of coated ffp respirators (glaxosmithkline actiprotect) with three ffp controls (sperian willson easy fit). for each test, suspensions of influenza a (h n ) at ae log tcid ⁄ ml in ae · minimum essential medium (mem) were aerosolised with a nebulizer. the airborne droplets were introduced into a sterile chamber upstream of a respirator sample for minutes, at a flow rate of ae l ⁄ minute. constant airflow was maintained for another minutes after exposure to the virus. then the collection dish in the downstream sieve sampler (anderson) was assayed for infectious viruses using standard techniques. briefly, serial dilutions of the collection medium (mem with % fbs, % gelatine, and % hepes, supplemented with antibiotics and amphotericin b) in mem + trypsin were used to inoculate madin-darby canine kidney epithelial (mdck) cells in quadruplicate in a multi-well plate. these cultures were then incubated and scored over - days for cytopathic effects, cytotoxicity, and viability. negative cell controls and cytotoxicity and neutralisation controls were also performed. the spearman-karber formula was used to calculate tcid . the second assay compared five samples of coated respirators with five ffp controls ( m ) and five ffp controls ( m ). a suspension of influenza a (h n ), at ae tcid ⁄ ml, was nebulized for minute and seconds into the aerosol chamber, at a flow rate of ae l ⁄ minute, followed by constant airflow for minutes after exposure to the virus. then the collection medium in the downstream chamber (as before, with % nahco ) was assayed as described above. initial viral loads in the first and second assays were ae and ae log tcid , respectively, and were therefore high in comparison with respiratory secretions from infected patients at the peak of their influenza symptoms (range - log t-cid ). table shows that the average viral load that passed through the uncoated ffp respirators in the first assay was ae log tcid . the average viral load that passed through the coated respirators was ae log tcid . therefore, for active filtration of viruses, the relative efficacy of the respirator with antiviral coating was ae log greater than the uncoated respirator. for surface inactivation, the relative antiviral efficacy of the coated respirator was ae log . in the second study, table shows that the average viral load that passed through the uncoated ffp respirators was ae log tcid . in contrast, ae log tcid passed through the coated ffp respirators. by comparison with the viral load when no respirator was present ( ae log tcid ), the ffp respirators reduced the viral load by ae log , and the coated ffp by ae log . therefore, for active filtration of viruses, the respirators with antiviral coating reduced the viral load by ae log more than the ffp respirators. in this second study, the average viral load that passed through the uncoated ffp respirators was also ae log tcid . by comparison with the viral load when no respirator was present ( ae log tcid ), the ffp respirators reduced the viral load by ae log . therefore, for active filtration of viruses, the respirators with antiviral coating reduced the viral load passing through the mask by ae log more than the ffp respirators. table also shows that the coated respirators reduced the infectious viruses remaining on the mask surfaces by ae log more than the ffp respirators, and ae log more than the ffp respirators. even with a very high viral challenge, the coated respirators prevented passage of at least an additional ae log infectious viruses, compared with uncoated respirators. large numbers of infectious virions passed through all uncoated respirators tested. ffp respirators were no more effective than ffp respirators at blocking airborne influenza viruses. based on these in-vitro results, respirators with the antiviral coating could be expected to provide more protection than standard respirators from the risk of inhaling influenza viruses. strategies to prevent transmission of influenza include use of respiratory protection. ffp and n respirators are certified to filter at least % of nacl particles ( ae lm in diameter), and many guidelines have recommended that healthcare workers wear these respirators in certain healthcare settings to protect against infection from patients with pandemic influenza. , we have developed a proprietary acid-polymer formulation, designed to coat a standard respirator and inactivate influenza viruses on contact. we tested this coated respirator for cytotoxicity, skin irritation, and sensitisation potential. the antiviral coating was also tested for stability and leaching under extreme environmental conditions, such as physical abrasion and simulated breathing at different temperatures, levels of humidity and co , and saturation with contaminants. eight coated respirators were tested at standard relative humidity ( % rh) for hours, and one at elevated humidity ( % rh) for hours. four coated masks were treated with synthetic blood or oral secretions, and then tested at % rh for hour. the sample respirators were sealed onto a mannequin head inside an airtight chamber, and air at °c and ppm co was pumped through the masks by a cyclic breathing machine at l ⁄ minute. a mm glass-fibre filter was placed behind the respirator, over the mannequin's mouth opening. at the end of all tests, these filters were eluted and analysed using high-performance liquid chromatography (hplc). standard in vitro methods were used to assess the cytotoxicity of the coated polyester and uncoated polypropylene layers of the respirator (glaxosmithkline actiprotect). samples were extracted in minimum essential medium (mem), supplemented with serum, penicillin, streptomycin, amphotericin b, and l-glutamine, at °c for hours. triplicate monolayers of mouse fibroblast cells (l- ) were dosed with each extract (including a reagent control and negative and positive controls), and incubated at °c in % co for hours. after hours of incubation with samples or controls, the monolayers of mouse fibroblast cells were examined microscopically for abnormal cell morphology or cellular degeneration. samples of the coated respirator (comprising four polypropylene layers bonded to the coated polyester outer layer) were applied under occlusive patch conditions to the skin of adults. controls, including individual layers, were applied in the same way. in a separate patch test, samples of the coated polyester outer layer and controls were applied under the same conditions to adults. after hours, test patches and controls were removed. sites were then scored for itching, erythema, oedema, epidermal damage, and papular response after and hours. the patches were applied three times a week for weeks. to evaluate sensitisation, test patches were applied - days later for hours at different sites to the original samples. after this challenge, skin was assessed and graded for sensitisation potential after and hours. table shows that no residues of the antiviral coating or degradation products were detected in the air that had passed through any of the eight respirators. cytotoxicity tests showed that the coated respirator material caused % cell lysis or toxicity, classified as slight reactivity (grade ), and that uncoated material caused no cell lysis or toxicity (grade ) ( table ) . results for positive and negative controls were severe reactivity and no reaction, respectively. from the results of the two human repeat-insult patch tests, neither the coated or uncoated layers nor the fullthickness respirator fabric caused irritation (including itching, erythema, edema, vesiculation, epidermal damage, papules, or reactions beyond the patch site) or sensitisation in any of the adult volunteers at any of the time points. based on these results, in conjunction with published data on acute and repeat-dose toxicity, mutagenicity, local irritation, dermal sensitisation, and inhalation safety for all components of the antiviral coating, the potential topical or inhalation exposure to the coated antiviral respirator does not pose a safety risk. the antiviral coating is durable and stable, and stays on the outer surface of the respirator, even in extreme environmental conditions. the coated respirator is non-irritating and non-sensitising. therefore, this respirator is considered to be well-tolerated and safe for its intended use. ies were funded by gsk consumer healthcare, and gsk investigators were involved in all stages of the study conduct and analysis. knowing how influenza virus is transmitted at home and in school is the key to preventing its spread. at the previous two meetings of this conference, , we introduced our study of household transmission of seasonal influenza and reported our conclusion that protracted survival of the virus even after treatment increases household transmission, and is a major factor in the transmission of the virus to infants. on the other hand, during the recent pandemic, many schoolchildren developed serious respiratory tract disorders, which again highlights the significance of schoolbased transmission of the disease. in this study, we compared transmission of a new influenza strain at home and in school with that of seasonal influenza and proposed countermeasures. the for the analysis of school-based transmission, the epidemic status of seasonal influenza in children at six elementary schools over the past two seasons ( - and - seasons) was compared with that of pdmh in children at two primary schools. using observational data of school-based transmission, we also constructed a model for influenza transmission , and evaluated the effects of factors that could affect influenza transmission (e.g., antibody prevalence, transmission rate, non-infectious latent period, infectious latent period, school closure) through the use of simulations. in this study, a diagnosis of influenza was confirmed by rapid influenza antigen detection kit. we previously reported the high sensitivity of the kits, - not only for seasonal influenza, but also for h n pandemic compared to virus isolation and pcr. serum antibody was not investigated. most of the index patients were treated with oseltamivir or zanamivir, and patients were treated with amatadine. no treatment was done for patients. no nai therapy was done as prophylaxis within the family. the incidence of households with an initial case patient who subsequently infected another member of the household was ae % ( of households) for seasonal influenza or ae % ( of households) for pdmh . thus, the household incidence of pdmh was lower than that of seasonal influenza. in addition, the percentage of family members in households who were infected by initial case patients (household transmission rate) was ae % ( of individuals) for seasonal influenza or ae % ( of individuals) for pdmh . thus, the household transmission rate was also lower for pdmh than that for seasonal influenza. effect of family size on household incidence and household transmission rate an analysis of the effect of family size on household incidence showed that, in families consisting of - individuals, the incidence of seasonal influenza in order of increasing family size was ae %, ae %, ae %, ae %, ae %, and ae %, respectively, and the incidence of pdmh was ae %, ae %, ae %, ae %, ae %, and ae %, respectively, indicating that household incidence tends to increase with increasing family size. in contrast, no definite relationship was noted between household transmission rate and family size. transmission rates for seasonal influenza in order of increasing family size were ae %, ae %, ae %, ae %, ae %, and ae %, respectively, or ae %, ae %, ae %, ae %, ae %, and ae %, respectively, for pdmh (shown in table ). effect of age cohort of initial case patient in household on household incidence and household transmission rate an analysis of the effect of the age cohort of the initial case patient in the household on household incidence and transmission rate showed that the household incidence of seasonal influenza in c , c , c , and c was ae % ( of households), ae % ( of households), ae % ( of households), ae % ( of households), and for m and f was ae % ( of households) and ae % ( of households), respectively. therefore, household incidence was the highest in c , followed by the parents. when the initial case patient was a child, the household incidence increased with decreasing patient age. in contrast, the household incidence of pdmh in c , c , c , and c was ae % ( of households), ae % ( of households), ae % ( of households), ae % ( of households), and for m and f was ae % ( of households) and ae % ( of households), respectively. therefore, household incidence was higher when the initial case patient was a parent, rather than a child. the household transmission rates for seasonal influenza from c to f were ae %, ae %, ae %, ae %, ae %, and ae %, respectively. therefore, as for household incidence, the highest rate ( ae %) was observed in c . the corresponding household transmission rates for pdmh were ae %, ae %, ae %, ae %, ae %, and ae %, respectively, with the highest transmission rates observed for infections from parents (shown in table ). if the rate of individuals with a secondary infection transmitted from the initial case patient in a household is presented as a percentage of the total number of affected individuals, the rates for seasonal influenza and pdmh were ae % ( of individuals) and ae % ( of individuals), respectively. therefore, the rate of individuals with a secondary infection was lower for pdmh than that for seasonal influenza. by age cohort, the corresponding rates of individuals for seasonal influenza in c , c , c , and c were ae % ( of individuals), ae % ( of individuals), ae % ( of individuals), ae % ( of individuals), and for m and f was ae % ( of individuals) and ae % ( of individuals), respectively. for pdmh , the corresponding rates in c , c , c , and c were ae % ( of individuals), ae % ( of individuals), ae % ( of individuals), ae % ( of individuals), and for m and f was ae % ( of individuals) and ae % ( of individuals), respectively. these findings indicate that, especially in the case of pdmh , most secondary infections in parents tend to be transmitted from another household member. the mean annual prevalence of seasonal influenza and the new influenza strain at the elementary schools for the two seasons was ae % and ae %, respectively, whereas the prevalence determined days after appearance of the first case in school was ae % and ae %, respectively. in the recent season at the same elementary schools, however, the prevalence was a high ae %. since the prevalence at days after the appearance of the first case in school was already ae %, these data show that the influenza virus spread quickly throughout the schools. at the schools with high transmission rates in the early period of the pandemic, new infections were confirmed even days after the school closure action was taken. these findings indicate that pdmh , the current influenza virus, has a long latent period during which it becomes infectious and spreads from infected individuals to numerous others in their vicinity. we constructed a model for influenza transmission in schools and estimated the time course of changes in the number of expected cases and the expected prevalence during the season. in this model, school children were divided into six groups depending on the stage of infection: uninfected period with no immunity, non-infectious latent period, infectious latent period, onset, post-onset infectious period, and immune period. it was assumed that schoolbased transmission occurred during the infectious latent period prior to onset and that no infections occurred during the post-onset infectious period because children were absent from school. due to the long latent period of pdmh , the distribution of the non-infectious latent period of pdmh was established as (day , day , day , day ) = ( %, %, %, %) and the distribution of the infectious period as (day , day , day ) = ( %, %, %). when simulations were performed under these conditions using the model for school-based transmission of influenza in which children from classes with an outbreak were kept at home for days, the time course of changes in the number of affected individuals actually observed and the time course of changes in the number of expected cases were determined. the expected prevalence under these conditions was %. to evaluate the effect of school closure, simulations were performed based on the assumption that children from affected classes were not kept at home for days. it was shown that there was an increase in the expected number of cases during the days corresponding to the period of actual school closure and that the expected prevalence increased to %. based on these findings, it was concluded that keeping children home from classes with an outbreak is an effective means of controlling the transmission of influenza in schools (shown in figure ). if the transmissibility of pdmh virus at home is estimated based on the speed of transmission and the degree to which pdmh is prevalent in schools, it would be expected that the household transmission of pdmh is also higher than that of seasonal influenza. in fact, the opposite is the case. this paradox can be explained in two ways. . the number of children aged or more and parents with pdmh influenza as a percentage of the total number of affected individuals is lower than those with seasonal influenza ( ae % versus ae %). further, although the number of parents with a secondary infection was high at home, the percentage of the total number of individuals with pdmh was a low ae % ( of individuals), compared to that for seasonal influenza ( ae % [ of individuals]). in other words, adults are less susceptible to pdmh infections and there was a correspondingly small number of affected individuals. therefore, it was considered that the transmission rate at home was lower than that at school for this reason. . the percentage of households with more than one affected individual within the same family was higher for pdmh at ae % ( of households) than for seasonal influenza at ae % ( of households). in the patients secondarily infected with pdmh , ae % of them showed symptoms of infection days or more after the onset in the first patient, suggesting that they were not infected at home, and the actual household transmission was ae % ( of households). therefore, although the prevalence was higher for pdmh , it seems that household transmission was lower because households with an affected individual implemented satisfactory control measures against infection. seasonal influenza differs greatly from pdmh influenza in its transmissibility at home and in school. in the household transmission of pdmh influenza, both the household incidence and household transmission rate of pdmh were low compared to those for seasonal influenza. although transmission of seasonal influenza from infants to parents was marked, in the case of pdmh , the reverse was true with transmission from parents to children being predomi-nant. it should be noted that household transmission in mothers was common in all eight seasons, suggesting the need to reconsider control measures against infection when nursing unwell family members. in the case of school-based transmission, pdmh was more prevalent than seasonal influenza, indicating that the virus spread quickly throughout the schools. this difference was attributed to the long infectious latent period when pdmh rapidly became rampant in the schools. an analysis of school-based transmission using a model for influenza transmission showed that, when % of the student population is infected, schools should be closed for five consecutive days in order to minimize the spread of the disease. the effectiveness of seasonal influenza vaccine in preventing pandemic and seasonal influenza infection: a randomized controlled trial introduction household transmission has been estimated to account for one-third of all influenza transmission, , and children are at high risk of spreading the disease. with reference to previous evidence, - some vaccine deployment strategies target children to prevent them from infection and transmitting influenza. nevertheless, few studies evaluated the effectiveness of vaccinating children in reducing household transmission. , during - , a pilot randomized controlled trial was conducted to investigate such effect by studying households with school age children randomized to receive trivalent inactivated seasonal influenza vaccine (tiv). the monovalent vaccine against pandemic influenza a (h n ) (ph n ) had yet been available until the end of the first wave. various conclusions have been made as to whether seasonal influenza vaccine might possibly protect against ph n . [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] we report findings on the effectiveness of tiv against ph n observed in our cohort. households were screened if they expressed interest after receiving invitation letters distributed via their children's school or an existing pediatric cohort study. to be eligible, the household had to include at least one child aged - years who was not allergic or hypersensitive to any of the tiv components. children known to have immunosuppressive conditions or other contraindications against tiv were also excluded. written consent and assent were obtained from participants aged above years and those aged - years, respectively. proxy written consent was obtained from legal guardians or parents for participants younger than years. ethical approval was obtained from the institutional review board of the university of hong kong. consented households were allocated to the tiv and placebo group (in ratio : ) according a code generated by block randomization with random block sizes of , , and . an independent nurse prepared . one child (study subjects) from each household in the tiv group received a single dose of tiv with one child from each household in the placebo group receiving a single dose of saline placebo. parents and legal guardians were asked to report any adverse reactions days following vaccination. all participants, study nurses, and other research staff were blinded to the allocation and administration of vaccine or placebo. the vaccine allocation sequence was only disclosed to the investigators at completion of the study. serum specimens were collected from subjects shortly before (november-december ), one month after vaccination (december -january ), and after the winter (april ) and summer influenza seasons (august-october ). serum specimens were obtained from household contacts at baseline and after the winter and summer influenza seasons. all household members recorded any fever ‡ . °c, chills, headache, sore throat, cough, presence of phlegm, coryza, or myalgia daily on a symptom diary. they were also invited to report to the study hotline immediately if they experienced at least of the above signs or symptoms. as a response, the study nurse would visit the households with any sick members and collect nose and throat swab from all household members. the households were also telephoned monthly or increased to fortnightly during influenza seasons to monitor for signs and symptoms and remind them to report to the hotline. supermarket or book vouchers (for children) were given to the households including us$ for each serum specimen collected, us$ . for each home visit, and us$ for completion of the study. serologically-indicated influenza infection was the primary outcome of this study. it was define as a ‡ fold rise in antibody titer within each influenza season. other study outcomes included rt-pcr confirmed influenza virus infection, acute respiratory illness (ari) (two of any of the above listed signs or symptoms), and influenza-like illness (ili) (fever ‡ . °c with cough or sore throat). antibody titers against the vaccine strains were obtained by testing each serum specimens by haemagluttination inhibition (hai). viral microneutralization (vn) using standard methods was found to be more sensitive than hai in detecting antibody response against a ⁄ california ⁄ ⁄ (h n ) in another study conducted by our group and was, therefore, used in this study. the sera was initially diluted at ⁄ and further tested in serial doubling dilutions. nose and throat swabs were tested by reverse transcription polymerase chain reaction (rt-pcr) for influenza a and b viruses. technical details of the laboratory methods have been reported elsewhere. , fisher's exact test and chi-squared tests were used to compare count data including occurrence of side effects, laboratory confirmed, and clinically defined influenza infections. wilcoxon signed-rank test were used to compare the serum antibody titers between groups. exact binomial method or the wald approximation was used to estimate % confidence intervals where appropriate. all analyses were carried out in r version . . (r development core team, vienna, austria). twenty-five primary and secondary schools in the district of the study clinic were invited to participate. to parents of three schools that agreed to take part and another study cohort, invitation letters were sent and households were enrolled. personal referrals were made from these parents to enroll additional households. among enrolled households, subject with history of epileptic seizure was assessed to be contra-indicated against receiving the vaccine. blood taking failed in another subject, and both of them withdrew from the study. eleven households did not complete the study. table shows subject and household contacts of the tiv and placebo group were similar in demographics and prior influenza vaccination history. antibody titers before vaccination were comparable between groups (data not shown). most study subjects who received tiv showed antibody titer ‡ against the vaccine strains month after receiving tiv, and the proportion was significantly higher than those who received placebo (a ⁄ h n % in tiv versus % in placebo group, p < . ; a ⁄ h n % versus %, p < . ; b % versus %, p = . ). none of the study subjects had antibody titer ‡ against ph n following receipt of seasonal tiv. no serious adverse reactions were reported, and only pain at injection sites was slightly higher in tiv group (data not shown). subjects who received tiv had lower rates of serologically confirmed seasonal influenza a(h n ) ( % versus %, p = . ), a(h n ) ( % versus %, p = . ) and b infection ( % versus %, p = . , although the differences were not statistically significant (table ) . study subjects had higher rate of serologically confirmed ph n infection ( % versus %, p = . ), yet it was not statistically significant. after adjusting for potential cross reactive antibody response, % of subjects in tiv versus % in placebo groups showed ph n infection confirmed by either serology or rt-pcr (p = . ). little differences were observed for rt-pcr confirmed infection, ari, and ili in results combining the winter and summer influenza seasons. during winter season when seasonal influenza predominated, study subjects who had received tiv showed a lower tendency to develop ili ( % versus %, p = . ) or ari ( % versus %, p = . ). an opposite tendency was seen (ili % versus %, p = . ; ari % versus %, p = . ) during summer when ph n predominated. however, these differences were not statistically significant. rates of ili in subjects infected with ph n did not differ statistical significantly between subject who received tiv and placebo ( % versus %, p = . ). the study was not powered to detect indirect benefits to household contacts of vaccines resulting from reduced household transmission. attack rates were found to be similar between household contacts of subjects received tiv and placebo (data not shown). to examine potential factors that might affect risk of laboratory confirmed ph n infection, a multivariable logistic regression model was fitted to study all subjects and their household contacts. younger participants aged below years were found to have a higher risk (< years or = . , % ci . , . ; - years or = . , % ci . , . , > or = . ). after adjusting for age, sex, and date of study completion, receipt of tiv for the - influenza season was not found to affect risk of ph n infection. however, participants who had laboratory confirmed seasonal influenza infection during the study period had % lower risk of ph n infection (infected with seasonal influenza or = . , % ci . , . ; not infected with seasonal influenza or = . ). as (see table s for winter and summer results separately). influenza-like illness (ili) defined as temperature ‡ . °c plus cough or sore throat; acute respiratory illness (ari) defined at least any two of fever ‡ . °c, chills, headache, sore throat, cough, presence of phlegm, nasal congestion, runny nose, muscle or joint pain. limited by the sample size, we were not able to differentiate between the protective effect of seasonal a(h n ) and a(h n ) infection against ph n . other details of the results from the study were published elsewhere. discussion a non-significantly higher rate of ph n infection was observed in study subjects who received tiv compared to placebo. results from a multivariable logistic regression suggested that such a pattern might be explained by more common seasonal influenza infection in placebo group prior to the pandemic, protecting the placebo group against ph n . seasonal influenza infection within - months observed in our study might have conferred better cross protection than tiv against ph n . this resembles similar previous findings on cross protection between influenza infections in human and animal studies. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] however, the same phenomenon has not been observed in some studies on seasonal influenza vaccine against ph n . , , [ ] [ ] [ ] apart from differences in study design and vaccine used, we speculate that a short time interval between ph n and most recent seasonal influenza peak activities might be crucial for the phenomenon. hong kong is a subtropical area where the pandemic was preceded immediately by summer seasonal influenza circulation and a few months apart from the winter - influenza peak. if cross protection from seasonal influenza lasts for only a short period, it might have waned below partial cross protection from tiv over time from last seasonal influenza infection. the current study is limited by a small sample size, and further studies are required to confirm our hypothesis. while tiv is only effective against matching strains, a universal influenza vaccine could provide better protection against the ever evolving influenza viruses. introduction immunisation of healthy, as well as high risk, children has been the focus of much recent attention both in prevention of seasonal influenza and during the h n pandemic. detailed information on reactogenicity, particularly for newer vaccine formulations that include adjuvants, is limited. we recently reported results of a head-to-head comparison of two h n pandemic influenza vaccines in children in the uk. here we present new, detailed analyses of reactogenicity data from that study, which has important potential implications for future paediatric influenza vaccine development and use. we compared the safety, reactogenicity, and immunogenicity of two h n influenza vaccines, one as b (tocopherol based oil in water emulsion) adjuvanted egg culture derived split virion, the other non-adjuvanted cell culture derived whole virion, given as two dose schedules days apart, in a randomised, open label trial as previously reported. the study was age stratified ( months to under years & - years) to ensure adequate data in young children. age appropriate safety data (simplified for under year olds) were collected for days after each vaccine dose and serum was collected at enrolment & days after the second dose. nine hundred-thirty seven children received vaccines as per-protocol. when comparing the two vaccines, grade ( ‡ mm) local reactions were seen more frequently following the adjuvanted than the non-adjuvanted vaccine in both age groups, after both vaccine doses. in children over years old, ae % versus ae %, p < ae , after dose one; ae % versus ae %, p = ae , after dose two, in children under years old, ae % versus ae %, p = ae , after dose one (non significant, ns); ae % versus ae %, p < ae after dose two. fever ‡ °c (axillary measurement) was seen more frequently following the second dose of the adjuvanted vaccine compared to the non-adjuvanted vaccine in < year olds ( ae % versus ae %; p < ae ). looking specifically at the adjuvanted vaccine in under year olds, comparing the second dose with the first, there were significantly higher rates of fever ‡ °c (axillary measurement) ( ae % versus ae %, p < ae ), local grade ( ‡ mm) reactions ( ae % versus ae %, p = ae ), pain ( ae % versus ae , p = ae ), use of analgesia or antipyretic medication ( ae % versus ae %, p < ae ), and decreased activity ( ae % versus ae %, p < ae ). the adjuvanted vaccine was significantly more immunogenic, most notably in the younger children. in < year olds, haemagglutination inhibition (hi) seroconversion rates were ae % versus ae %, p < ae . among all general and local reactions measured, only the maximum temperature measured during the days after the second dose of the adjuvanted vaccine showed a significant (positive) association with post vaccination hi titres. for each °c rise in temperature there was a % increase in titre (p < ae ). these reactogenicity data demonstrate a step towards the future possibility of one-dose influenza immunisation programmes for young children associated with low rates of fever and other reactions. the occurrence of fever following adjuvanted vaccine, seen particularly after a second dose in younger children, was quantitatively associated with enhanced antibody titres. this association was not seen with unadjuvanted vaccine. this apparent difference between the relatedness of the pyrogenic and immunogenic effects of the two vaccines merits further investigation. novel adjuvants appear to have the potential to overcome the relatively poor immunogenicity previously experienced with inactivated influenza vaccines in infants and young children. however, careful adjustment may be needed to optimise the balance between high protection and acceptable reaction rates. tries causing sporadic human infections. vaccination has been used as an effective public health tool for influenza prophylaxis. the goal of this study was to evaluate live attenuated influenza vaccine (laiv) vaccine candidates for subtypes h and h . the attenuated phenotype of h and h laiv candidates has been proven in experiments in ovo and in vivo. in randomized clinical trials among adult volunteers, no significant adverse reactions attributable to the live vaccine occurred. our results indicate that pandemic laiv candidates were well tolerated and elicited serum, local, and cellular immune responses. the emergence and spread of highly pathogenic avian influenza h n viruses in avian populations and concurrent infections in humans since has prompted efforts to develop vaccines for use in the event of an influenza pandemic. in , the world faced a new h n pandemic. immunization with inactivated or live vaccines is the primary measure for preventing influenza. laivs appear to be safe and efficacious, and might possibly provide broader immune responses than inactivated vaccines. our study evaluated laiv pandemic candidates as part of the global influenza pandemic preparation project outlined by the who. capacity of the viruses to grow at optimum, low, and elevated temperatures (ca ⁄ ts phenotype) was evaluated by routine technique in embryonated hen eggs. laiv and placebo were supplied by microgen (irkutsk, russia). the monovalent laiv was produced from the pandemic vaccine candidates and formulated to contain and ae eid per dose ( ae ml) of a ⁄ ⁄ california ⁄ ⁄ and a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ , respectively. the vaccine or placebo was administered intranasally with a single-use dosing nasal sprayer. two doses were given at an interval of days. one hundred-ninety healthy adults aged - years were randomly divided into groups to receive either pandemic vaccine candidates ( ) or placebo ( ) . subjects were informed about purposes and methods of the study and potential risks associated with participation. all participants had an hai antibody titer of £ : to a ⁄ california ⁄ ⁄ (h n ) pandemic virus. in all there were and vaccines and and participants who received placebo, and were further tested for immune responses to h n or h n pandemic vaccine, respectively. another participants vaccinated with h n laiv were children between to years old. before the children were vaccinated, their parents were advised about study and their consent was required before any child was enrolled. on the advice of the national ethics committee, we did not include a placebo group in this study. individuals were not enrolled if they had an acute illness or fever at the beginning of the study or a history of egg allergy. immune responses of subjects were assessed by routine hai test (evaluation of serum igg antibodies), elisa (evaluation of iga antibodies eluted from the nasal swabs into steril pbs), and cytokine flow cytometry assay (evaluation of virus-specific cd + cd + ifnc + and cd + cd + ifnc + peripheral blood mononuclear cells). the results of phenotypic analysis in ovo showed that pandemic vaccine candidates retained the cold adapted-temperature sensitive (ca ⁄ ts) phenotype, typical of the coldadapted parental mdv. in contrast and as expected, a ⁄ california ⁄ ⁄ and a ⁄ duck ⁄ potsdam ⁄ - parental strains had the non-ts ⁄ non-ca phenotype typical of wt viruses. the h n pandemic vaccine candidate demonstrated an attenuated phenotype in mice and in java macaques and did not infect chickens. the vaccine attenuation study confirmed the attenuated phenotype of a a ⁄ ⁄ california ⁄ ⁄ pandemic laiv candidate in mouse, ferret, and guinea pig models. the phase i ⁄ ii randomized, controlled, double-blind clinical study safety evaluation of pandemic vaccine candidates in adults clinical examination of subjects who received two doses of pandemic vaccine candidates indicated that both vaccines were well tolerated. no fever reactions were observed after the first or second vaccination. after the first vaccination, ae % and ae % of reactogenicity events consisting of catarrhal symptoms, such as pharyngeal irritation or hyperemia, were observed for h n and h n vaccine candidates, respectively. after revaccination, subjects did not report local or systemic reactions. to determine whether a serological response occurred in the cohort of immunologically naïve subjects vaccinated with pandemic vaccine candidates, hai and elisa tests were used (table ) . post-vaccination geometrical mean titers (gmt) among subjects who received two doses of h n vaccine were significantly higher than pre-vaccination titers. the frequency of ‡ fold antibody rises was significantly higher ( ae %) after revaccination than after one dose ( ae %). the percentage of subjects with post-vaccination serum hai titers to h n ‡ : was ae % and for titers ‡ : , it was ae %. no seroconversions in the placebo group were detected. the virus-specific nasal iga antibody response to vaccination after two doses of the h n vaccine candidate demonstrated significant increases of ‡ fold rise iga antibodies ( %) compared to one dose. cumulative data of h n vaccination (all applied tests) showed % and % of conversions after the first and the second vaccination, respectively. increasing h n vaccine virus infectivity from ae to ae eid ⁄ dose lead to an enhancement of post-vaccination hai titers in vaccinees after the first vaccination to homologous h n antigen from ae % to ae % of ‡ fold antibody rises. values of post-vaccination serum hai antibody titers in subjects vaccinated with another pandemic vaccine candidate, a ⁄ ⁄ california ⁄ ⁄ , also proved to be rather low. after the primary vaccination, the percentage of subjects with hai protective antibody titers ‡ : were ae %. after revaccination, this parameter increased to ae %. four-fold increases in serum hai antibody titres were four-fold conversions after the first and the second vaccination was ae % and ae %, respectively. elisa antibodies in nasal swabs showed had an advantage in detecting induction of local iga as compared to serum hai antibodies. after revaccination four-fold serum hai antibody conversions were ae % vs. ae % of iga conversions in nasal swabs, respectively. taking into account cumulative data of h n vaccination (hai and elisa data), the obtained results were here and in the ae % and ae % of conversions after the first and the second vaccination, respectively. fourty-seven subjects were vaccinated with h n laiv, and who received a placebo were chosen for evaluation of cellular immune response by cytokine assays. after revaccination, the mean increases of both cd + and cd + memory cells were significantly higher in vaccinated subjects compared to the placebo group. interestingly, the same effect of vaccination was observed in vaccinees without detectable conversions of hai antibody titers. even after a single vaccination, the rate of subjects with significant increases of these cells in the blood was ae % (cd + ) and % (cd + ). after the revaccination, the percentage of subjects with significant increases in cd + and in cd + cells was ae %. immunogenicity of h n pandemic vaccine candidate in children hai antibody results among children aged to years proved to be significantly higher when compared to adult subjects: after the first vaccination, ae % of the children seroconverted; after revaccination, seroconversions reached ae % ( table ). the gmt rise to h n vaccine with primary vaccination was : ; after revaccination it increased to : . benefits of vaccination with laiv to aid in the control of influenza outbreaks are acknowledged by the who. many years of laiv seasonal trials have shown excellent tolerability and low reactogenicity. [ ] [ ] [ ] indeed, data showed that live influenza vaccines cause minimal systemic, local, and thermal reactions, generally from to %. a different situation was observed in the cohort of immunologically naïve volunteers vaccinated with pandemic vaccines. the rate of local reactions to a ⁄ ⁄ california ⁄ ⁄ and a ⁄ ⁄ duck ⁄ potsdam ⁄ ⁄ vaccine candidates increased to ae % and ae %, respectively. after revaccination no significant local and systemic reactions were observed. this confirms, indirectly, the development of a sufficiently high level of protection after the first vaccination with pandemic laiv. the most important criterion for assessing the quality of vaccines is their estimated safety, epidemic effectiveness, and immunogenicity. however, current regulatory documentation mandates that induction of serum antibodies, measured by hai, as the only criterion for a laiv immunogenicity evaluation. in addition to the standard hai assay, we determined serum (igg) and local (iga) antibodies in adult subjects vaccinated with an h n pandemic vaccine candidate. evaluation of overall results obtained in these additional serological tests, as well as those from the hai assay, showed an immune response to the vaccine in the majority of subjects ( ae % of ab seroconversions after the single vaccination and ae % after revaccination, respectively). these data show that methods used to routinely measure laiv immunogenicity should be revised to include a number of additional immunological methods such as igg and iga elisa, and cytokine assays consistent with the recently updated who recommendations on laiv monitoring. these clinical studies clearly demonstrated that pandemic laiv candidates are effective at generating pandemic specific influenza immunity. a key finding from this study is that it may be practical to give the vaccine as a single dose to both children and adults. evaluation of our laiv pandemic vaccine candidates was performed as part of the global influenza pandemic preparation project outlined by the who. it was considered that laiv could be produced in greater quantities and more rapidly than inactivated vaccines. together with the generation of herd immunity by laiv, this suggests that laiv implementation during the first wave of a pandemic may provide significant social, economic, and health benefits to the community. authors are thankful to path for the financial support of h n pandemic vaccine study. we are grateful for the the main evolutionary mechanism of influenza viruses during inter-pandemic period is the antigenic drift, but the epidemiological picture of circulating viruses is complicated by a high level of heterogeneity of strains, even though drift does not occur, due to co-circulation of drifted and old strains or to co-circulation of viruses belonging to the same type ⁄ subtype but with different antigenic patterns. [ ] [ ] [ ] [ ] [ ] [ ] lack of data exists on the impact of the wide heterogeneity of circulating strains on the seroprotection and on-field effectiveness of influenza vaccine: in particular, little is known about the ability of influenza vaccine to elicit an effective immune response against isolates with few amino acid mutations with respect to vaccine strains that represent the majority of circulating viruses. mf -adjuvanted vaccines, which are currently used for the prevention of seasonal influenza epidemics in elderly, are showed to confer higher seroprotection against homologous and drifted a(h n ) strains than non-adjuvanted vaccines. [ ] [ ] [ ] the broader immune response showed by mf -adjuvanted vaccine was measured using hi and nt assays against egg-grown drifted strains representing vaccine composition changes during the following seasons, but its ability to elicit a broader immune response against circulating viruses belonging to vaccine cluster and presenting amino acid mutations onto antigenic sites or against on-field isolates not-antigenically distant from vaccine strains has not yet been investigated. showing amino acid changes onto antigenic sites in position (n k), (n k), and (p s) with respect to a ⁄ california ⁄ ⁄ . in particular, a ⁄ genoa ⁄ ⁄ and a ⁄ genoa ⁄ ⁄ presents n d amino acid mutation detected in clade a ⁄ wyoming ⁄ ⁄ -like viruses. the ha sequences of a ⁄ genoa ⁄ ⁄ , a ⁄ genoa ⁄ ⁄ , genoa ⁄ ⁄ , a ⁄ genoa ⁄ ⁄ , and a ⁄ genoa ⁄ ⁄ fell within the clade represented by the ha of a ⁄ califor-nia ⁄ ⁄ ; among these isolates, a ⁄ genoa ⁄ ⁄ and a ⁄ genoa ⁄ ⁄ showed antigenic site sequences very close to that of the ⁄ vaccine strain, whereas ha sequences of a ⁄ genoa ⁄ ⁄ , a ⁄ genoa ⁄ ⁄ ⁄ and a ⁄ genoa ⁄ ⁄ posses amino changes onto antigenic site a(r k), c(g e) and d(r k), respectively. the ha sequences of more recent isolates fell within the clade represented by the ha of a ⁄ brisbane ⁄ ⁄ and characterized by the amino acid changes, relative to the ha of a a ⁄ california ⁄ ⁄ , g e and k i, with the exception of a ⁄ genoa ⁄ ⁄ , showing r g and l s amino acid changes present in viruses belonging to a ⁄ nepal ⁄ ⁄ clade. measure of genetic distance between vaccine and circulating strains was calculated as previously described by gupta. two blood samples were collected from each subject, just before and ± day post-vaccination. all sera were stored at ) °c. all samples were tested at the laboratory of health sciences department, university of genoa, by haemagglutination-inhibition (hi) and neutralization (nt) assays, performed following the who criteria and standardised method in our laboratory, respectively. [ ] [ ] [ ] guinea pig red blood cells were used for hi assay. all samples were assayed twice for hi and for nt. the obtained antibody titre was expressed as the reciprocal of the last sera haemagglutinating or inhibiting virus dilution. immunogenicity was determined by: geometric mean titre (gmt); mean-fold increase (mfi; ratio of post-to pre-vaccination titre); seroprotection rate (the percentage of subjects achieving an hi and nt titre ‡ iu); and seroconversion rate (percentage of subjects with a fourfold increase in hi or nt antibody titers, providing a minimal post vaccination titer of : ). post-vaccination gmt was reported as ratio, with the corresponding % confidence interval, of gmts after vaccination with mf -adjuvanted vaccine and with non-adjuvanted subunit vaccine. seroprotection and seroconversion rate % confidence interval was calculated using modified wald method. comparisons of seroconversion and seroprotection rates between subunit and mf -adjuvanted vaccine groups have been analyzed by fischer's exact test. the results were evaluated against the committee for medicinal products for human use (chmp) criteria for approval of influenza vaccines in the elderly, which require that at least one of the following criteria be met: mfi > ; seroprotection rate > %, or seroconversion rate > %. furthermore, hi titres were also transformed into binary logarithms, corrected for pre-vaccination status, as described by beyer et al. and were expressed as median titres, with the corresponding °- °i nter-quantile range. comparisons of corrected post-vaccination titers between subunit and mf -adjuvanted vaccine groups were analyzed by wilcoxon test. difference in immunogenicity profile between vaccine groups, expressed by ratio of different parameters, was correlated with genetic and antigenic distance between vaccine and viruses used in the study using spearman test. pre-vaccination titres were not significantly different between vaccine groups, for all strains (data not shown). post-vaccination gmt ratios between mf -adjuvanted and non-adjuvanted vaccine groups determined using hi and nt assays, with the corresponding % confidence interval, according to viral strain are shown in figure . both vaccines met chmp requirements for mfi (> ), seroconversion (> %), and seroprotection rate (> %) against a ⁄ wyoming ⁄ ⁄ -like, with the exception of a ⁄ genoa ⁄ ⁄ and a ⁄ california ⁄ ⁄ -like circulating viruses and against egg-grown a ⁄ wyoming ⁄ ⁄ , a ⁄ california ⁄ ⁄ , and a ⁄ wisconsin ⁄ ⁄ strains; the immune response against a ⁄ genoa ⁄ ⁄ met the requirements for mfi and seroprotection rate only in mf -adjuvanted vaccine group. requirements for mfi, seroconversion, and seroprotection rate against the a ⁄ brisbane ⁄ ⁄ -like virus a ⁄ genoa ⁄ ⁄ and the a ⁄ nepal ⁄ ⁄ -like genoa ⁄ ⁄ viruses and against egg-grown a ⁄ brisbane ⁄ ⁄ strain were reached only in subjects vaccinated with the mf adjuvanted vaccine. a similar pattern emerged from the analysis of mfi, seroconversion and seroprotection rates using nt assays. subjects vaccinated with the mf -adjuvanted vaccine showed significantly higher post-vaccination hi gmts against a ⁄ wyoming ⁄ ⁄ -like, a ⁄ california ⁄ ⁄ -like, a ⁄ nepal ⁄ ⁄ -like and a ⁄ brisbane ⁄ ⁄ like viruses, with the exception of a ⁄ genoa ⁄ ⁄ , and against egg-grown a ⁄ california ⁄ ⁄ , a ⁄ wisconsin ⁄ ⁄ , and a ⁄ brisbane ⁄ ⁄ strains, compared with individuals immunized with the non-adjuvanted vaccine ( figure ). the mf -adjuvanted vaccine also induced significantly higher seroconversion and seroprotection rates against following correction for pre-vaccination status, hi titres were significantly higher for the mf -adjuvanted vaccine group when evaluated against a ⁄ wyoming ⁄ ⁄ -like viruses, a ⁄ brisbane ⁄ ⁄ -like a ⁄ genoa ⁄ ⁄ , and a ⁄ nepal ⁄ ⁄ -like a ⁄ genoa ⁄ ⁄ strain ( figure ). pre-vaccination titre corrected response was higher in subjects vaccinated with mf adjuvanted vaccine also against egg-grown a ⁄ wyoming ⁄ ⁄ , a ⁄ california ⁄ ⁄ ⁄ , a ⁄ wisconsin ⁄ ⁄ , and a ⁄ brisbane ⁄ ⁄ . among viruses more closely related to a ⁄ california ⁄ ⁄ , subjects immunized with mf -adjuvanted vaccine showed a significantly higher corrected titres against a ⁄ genoa ⁄ ⁄ , a ⁄ genoa ⁄ ⁄ , and a ⁄ genoa ⁄ ⁄ strains compared with the non-adjuvanted vaccine ( figure ) . spearman test showed a clear correlation between the distances and the advantage offered by mf expressed by ratio between mfi, post-vaccination gmts, corrected post-vaccination median, seroconversion, and seroprotection rates calculated using hi test in the two vaccine groups. similarly, ratio between mfi, seroconversion, and seroprotection rates calculated with nt test correlated with the genetic and antigenic distance between vaccine and viruses used for the study. the ability of mf to enhance the immunogenicity and to elicit a broader immune response against drifted strains than non-adjuvanted vaccine is consistent with other findings reported during the last decade. [ ] [ ] [ ] in subjects vaccinated with the mf -adjuvanted vaccine containing a ⁄ california ⁄ ⁄ , the immune response, expressed by a number of parameters, such as crude and corrected postvaccination titers, seroconversion, and seroprotection rates calculated using hi and nt assays, is higher than that observed in individuals immunized with subunit vaccine when it is evaluated against a drifted strains, such as a ⁄ brisbane ⁄ ⁄ -like and a ⁄ nepal ⁄ ⁄ -like strains, and against egg-grown a ⁄ brisbane ⁄ ⁄ virus. for the first time in this study, the impact of heterogeneity of circulating strains antigenically close to the vaccine on the antibody response elicited by mf -and non-adiuvanted vaccines is evaluated. immune response against viruses isolated during the ⁄ season, that appear more phylogenetically close to ⁄ vaccine strain a ⁄ wyoming ⁄ ⁄ , was higher in subjects vaccinated with mf -adiuvanted vaccine as demonstrated by higher crude and corrected post-vaccination hi titres and higher postvaccination nt titres, with the exception of a ⁄ genoa ⁄ ⁄ , against whom the nt post-vaccination gmt is identical in mf and subunit vaccine groups. furthermore, hi seroconversion and seroprotection rates were higher in mf vaccine group when evaluated against a ⁄ genoa ⁄ ⁄ and a ⁄ genoa ⁄ ⁄ . as far as the immune response against a ⁄ california ⁄ ⁄ -like viruses, the small number of enrolled subjects did not allow appreciating differences using qualitative response indicators, but crude post-vaccination hi titres were higher in mf vaccine group for all the strains. interestingly, a ⁄ california ⁄ ⁄ -like viruses with at least one amino acid change onto antigenic sites, i.e. a ⁄ genoa ⁄ ⁄ , a ⁄ genoa ⁄ ⁄ , and a ⁄ genoa ⁄ ⁄ , showed a more marked difference in terms of response between the two vaccine groups. individuals immunized with mf -adiuvanted vaccine showed higher corrected post-vaccination hi titres and post-vaccination nt titres in comparison with subjects vaccinated with plain vaccine. these response indicators were similar in the two vaccine groups when the response was evaluated against a ⁄ genoa ⁄ ⁄ and a ⁄ genoa ⁄ ⁄ , which present no amino acid changes onto antigenic sites and identical hi titers respect with a ⁄ california ⁄ ⁄ at molecular and antigenic characterization, respectively. thus, the advantage offered by mf in terms of higher immunogenicity expressed by higher post-vaccination hi titres is observable also against viruses showing antigenic and molecular pattern undistinguishable from vaccine strain, but it became even more evident as the antigenic and molecular distance between vaccine and circulating strains grew. as emerged for a ⁄ genoa ⁄ ⁄ , a ⁄ genoa ⁄ ⁄ , and a ⁄ genoa ⁄ ⁄ , one amino acid was a sufficient change in antigenic sites for -fold decrease of hi titre against homologous vaccine strain to observe -fold higher post-vaccination nt titers (mf ⁄ subunit postvaccination gmt ratio range between ae and ae , figure ) and one-dilution higher corrected post-vaccination hi titers in mf vaccine group ( figure ) . finally, the correlation between the distance and the improvement offered by mf in terms of higher immunogenicity clearly emerged by spearman correlation analysis: it remains wellfounded both using a number of different response parameters obtained from hi and nt assays and calculating the distance by serological and genetic methods. outbreaks of h n pdm in pigs in commercial swine operations have been reported in several countries. in all incidents, epidemiological investigations have linked humans as the possible source of the infection to pigs. experimentally, it was established that the virus is pathogenic and transmits readily in pigs. the natural outbreaks of h n pdm and laboratory studies underscore the threat that the virus poses to the swine industry and highlight the need for developing effective control strategies. in the united states, a trivalent live attenuated influenza vaccine (flumistÒ) has been licensed for use in humans since . in swine medicine, however, temperature-sensitive laivs are not available. currently, only inactivated vaccines are available for pigs, but they provide limited protection against antigenically diverse influenza viruses. additionally, the use of inactivated vaccines has been associated with enhanced pneumonia when immunized pigs were challenged with divergent viruses. thus, the development of laivs has the potential to circumvent the drawbacks associated with commercial vaccines. with the aim of developing laiv temperature-sensitive influenza vaccines against the h n pdm virus, we have used reverse genetics to introduce attenuation markers in the polymerase genes of a swine-like tr h n influenza virus, a ⁄ turkey ⁄ ohio ⁄ ⁄ (h n ) (ty ⁄ ). we chose this isolate because it grows well in both eggs and cell culturebased substrates, displays a broad host range, and has internal genes similar to the h n pdm virus. safety and efficacy studies of the ty ⁄ att vaccine candidates in pigs demonstrated that this vaccine backbone is attenuated in swine and conferred sterilizing immunity upon an aggressive intratracheal challenge of pigs with the h n pandemic virus. thus, introduction of genetic signatures for att in the backbone of a swine-like tr influenza virus resulted in highly attenuated and efficacious live influenza vaccines with promising applications veterinary medicine. -t cells and mdck cells were maintained as previously described. a ⁄ turkey ⁄ ohio ⁄ ⁄ (h n ) (ty ⁄ ) has options for the control of influenza vii ª blackwell publishing ltd, influenza and other respiratory viruses, (suppl. ), - been previously described and it was kindly provided by yehia saif, ohio state university. a ⁄ california ⁄ ⁄ (h n ) (ca ⁄ ) was kindly provided by the centers for disease control and prevention (cdc). generation of recombinant viruses by reverse genetics (rg) was done using a previously described method. the genetic signatures for attenuation were introduced into the pb and pb genes of ty ⁄ . ny : ty ⁄ att is a : reassortant with the surface genes from the a ⁄ new york ⁄ ⁄ (h n ) virus and the ty ⁄ att internal genes. all viruses were amplified in mdck cells to produce viral stocks. twenty-five pigs were divided into five groups (n = ) and intranasally inoculated with tcid ⁄ animal of either h n : ty ⁄ att or with ny(h n ) : ty ⁄ att vaccines diluted in ml of mem. two other groups were similarly inoculated with h n : ty ⁄ wt and h n : ty ⁄ rg and served as controls, whereas a fifth group was mockvaccinated with pbs alone. clinical observations were performed as previously described. , efficacy of h n ty ⁄ att vaccine in pigs fourty pigs were divided in four groups (n = )( table ) . group was vaccinated with tcid ⁄ animal of ny(h n ) : ty ⁄ att through intranasal route, whereas group was vaccinated intramuscularly with ml of an adjuvanted uv-inactivated ca ⁄ vaccine (uvadj-ca ⁄ ). group , non-vaccinated and challenged (nv+ca ⁄ ), and group , non-vaccinated, mock-challenged (nv+mock), were also included. pigs were boosted two weeks later. fourteen days post boost (dpb), pigs from groups - were challenged intratracheally with ml of · tcid of ca ⁄ . following challenge, pigs were monitored using methods as previously described. all statistical analyses were performed using graphpad prism software version ae (graphpad software inc., san diego, ca). the differences were considered statistically significant at p < ae . the ty ⁄ att-based vaccines are attenuated in swine pigs inoculated with wt ty ⁄ viruses developed fever (> °c) that peaked hpi ( figure a) and shed large amounts of in nasal secretions ( figure b) . similarly, viral titers in bronchoalveolar lavage fluid (balf) collected at dpi ranged from to tcid ⁄ ml ( figure c ). at necropsy, the lungs from animals inoculated with these viruses had severe pneumonia ( figure d ). in contrast, none of the animals inoculated with h n or h n ty ⁄ att viruses developed clinical signs following vaccination, indicating that the ty ⁄ att viruses were safe for administration to pigs ( figure a) . correspondingly, there was - fold less virus shedding from the nose of pigs vaccinated with ty ⁄ att viruses as compared to unmodified ty ⁄ viruses. in general, ny(h n ) : ty ⁄ att -vaccinated pigs shed less virus than h n : ty ⁄ att inoculated pigs ( figure b ). in addition, viral titers in balf were significantly reduced (p < ae ) in ty ⁄ attvaccinated pigs as compared to ty ⁄ wt-infected pigs ( figure c ). although both vaccines caused mild gross and microscopic lesions in the lungs, the percentage of lung ae ± ae * ± * ± * ± * balf, bronchoalveolar lavage fluid, uvadj-ca ⁄ , uv-inactivated ca ⁄ vaccine; nv+ca ⁄ , non-vaccinated, challenged positive control group; nv+mock, non-vaccinated, non-challenged negative control group. *significantly different from nv+ca ⁄ control group at p < ae . geometric mean hi titer against ca ⁄ at the day of challenge. à percentage of macroscopic lung lesions given as mean score ± sem. § average viral titer (log ) measure as tcid per ml. -average viral titer (log ) in balf at dpc. involvement was not significantly different from mock-vaccinated pigs, corroborating the clinical findings that these vaccines are sufficiently attenuated in pigs ( figure d, e) . histopathologically, nasal turbinates and trachea obtained from pigs immunized with either vaccine were similar to control animals, as opposed to the wt-inoculated pigs ( figure e ). vaccination with h n ty ⁄ att-based vaccines provides sterilizing immunity against h n pdm in pigs the clinical performance in pigs of the h n vaccines is summarized in table . nv+ca ⁄ animals had macroscopic pneumonia, viral replication in balf and shedding in the nose. uvadj-ca ⁄ vaccine provided satisfactory protection, but this protection was not sterilizing. remarkably, animals vaccinated with ny(h n ) : ty ⁄ att had sterilizing immunity. in both vaccine groups there was a significant reduction (p < ae ) in the percentage of macroscopic lung pathology compared to the nv+ca ⁄ group. control pigs had neither significant macroscopic nor microscopic lesions in the lungs. hi antibody titers measured at the day of challenge in both vaccine groups were approximately the same (table ). in the present study, we developed for the first time, temperature-sensitive laiv for use in pigs. data from our safety studies showed that both the h n and h n ty ⁄ att vaccines were attenuated in pigs. although the ty ⁄ att vaccines were detected in balf samples, the level of viral replication was significantly reduced in comparison to unmodified virus and, more importantly, caused no overt clinical signs. a minimal amount of replication is likely beneficial for eliciting t-cell responses to internal genes that may provide heterologous cross-protection. one of the most challenging tasks in producing effective live attenuated vaccines is to achieve an adequate balance between safety and efficacy. by introducing the att modifications into the polymerase genes of a swine-like tr strain, this desirable balance was achieved. the vaccines were histopathologic scores of nasal turbinates, trachea and lungs at dpi. ny(h n ) : ty ⁄ att (a virus that carries the surface genes of a ⁄ new york ⁄ ⁄ (h n ) and ty ⁄ att internal genes). all h n viruses have their surface genes derived from ty ⁄ . values are shown as the mean ± sem. * p < ae ; **p < ae ; *** p < ae . options for the control of influenza vii ª blackwell publishing ltd, influenza and other respiratory viruses, (suppl. ), - attenuated in pigs and, more importantly, provided sterilizing immunity upon an aggressive challenge with pandemic h n as opposed to an experimental ca ⁄ inactivated vaccine, which elicited protective but not sterilizing immunity in all animals. in the face of influenza pandemics that have the ability to overcome the species barriers such as the h n , the supply of vaccines for use in agriculture could be jeopardized. our cell culture-based live att h n vaccines could be an attractive alternative for this possible pandemic vaccine shortage. because the ty ⁄ att live vaccines developed here are efficacious in swine, are easier to manufacture than inactivated vaccines, and do not require adjuvants, our study represents a major advance in vaccine development for the h n pandemic. in conclusion, our second generation of live att influenza vaccines based on modifications of the pb and pb genes of ty ⁄ retains its safety properties in vivo and can induce excellent protection against aggressive h n challenges in the swine host. influenza virus is one of the most important respiratory pathogens worldwide. , type a influenza causes an acute disease of the upper airways, and affects - million persons yearly. moreover, the threat of human influenza epidemic and pandemic has dramatically increased in recent years. vaccination is one of the crucial interventions for reducing the spread and impact of influenza. the generally used parenteral inactivated influenza vaccines induce mainly systemic antibody responses and only weak cell-mediated immunity and low levels if any mucosal immunity. on the other hand, intranasal immunization with live virus can induces a broad spectrum of both systemic and mucosal antibodies, and the immune response localized in the mucosa blocks the virus even during the first phase of infection. unfortunately, the use of live vaccines is always associated with a certain risk. the development of a crossprotective vaccine against potentially pandemic strains is an essential part of the strategy to control and prevent a pandemic outbreak. we induced intrasubtypic and intersubtypic cross-protection in balb ⁄ c mice by intratracheal (it) immunization with inactivated influenza viruses together with dead delipidated bacillus firmus (dbf) as an adjuvant. ten days after the nd immunization dose, the mice were infected with live influenza virus b ⁄ lee ⁄ lethal for mice (total infection dose corresponded to · ld ) or a⁄ pr ⁄ (total infection dose corresponded to ae - ld ). dbf adjuvant markedly increased both systemic and mucosal anti-viral antibody formation when applied together with inactivated influenza a or b viruses. protective significance was tested in vivo. mice were preimmunized with ) pbs (controls), ) dbf alone, ) virus alone, and ) vir-us+dbf. influenza b virus strains b ⁄ lee and b ⁄ yamanashi ⁄ ( years phylogenetically distant and antigenically substantially different, especially in terms of the main protective antigen -surface haemagglutinin) or two different influenza a subtypes -a ⁄ pr ⁄ (h n ) and a ⁄ california ⁄ (h n ) -were used (figures and ) . the mice were challenged with · ld of either b ⁄ lee ⁄ or a ⁄ pr ⁄ as appropriate. all controls died. the mice treated with dbf alone died with a delay or survived, which could be explained by stimulation of innate immunity. the animals immunized with virus alone were protected against homologous strains. adjuvant immunization was cross-protective: the mice immunized with a heterologous b strain (figure ) fell ill (pronounced body mass loss), but almost all survived and recovered. the mice immunized with a heterologous a subtype were excellently protected (negligible weight loss and zero mortality). intratracheal dbf ( lg per mouse) given to non-immunized mice hour before influenza infection eliminated the lethal effect in - % of infected animals depending on infection dose ( ae - ld ); in mice infected with lower than lethal doses ( ae ld ), weight loss was minimized or did not occur. the current mode of vaccination-induced immunity is mostly effective against a homologous strain of the virus used for vaccination. the attention is therefore focused on vaccines that are able to induce cross-protection and could be effective also in case of sudden appearance of a new virus variant. inactivated influenza viruses are known to be often insufficiently effective when used for mucosal immunization and for induction of cross-protection against drifted influenza viruses or novel subtypes. the drawback of vaccination with dead virus can be overcome by using a suitable adjuvant. mouse models were successfully immunized with vaccine containing inactivated virus in combination with cholera toxin or the escheria coli heat-labile toxin (lt). [ ] [ ] [ ] the use of cholera toxin in humans is precluded because of its high toxicity; a number of lt mutants that retain their adjuvant activity have been prepared; these mutants were likewise tested on the mouse model and should not cause any serious side effect in humans. for this reason, current studies aim at finding a suitable and safe mucosal and systemic immune response. dbf has been shown to be a very efficient adjuvant for mucosal immunization stimulating both innate and adaptive immunity. intratracheal immunization with inactivated influenza viruses and dbf as adjuvant induced efficient and even heterosubtypic cross-protection. dbf given hour before infection provided partial protection probably because of its strong stimulatory effect on the innate immunity. temperature-sensitive and cold-adapted candidates for live attenuated influenza vaccine with genomic composition of : based on highly pathogenic influenza a ⁄ h n viruses with pandemic potential were generated by the replacement of six internal genes from the influenza a ⁄ puerto rico ⁄ ⁄ (pr ) virus from pr -based rg-candidates for inactivated vaccine with appropriate internal genes of influenza a ⁄ leningrad ⁄ ⁄ ⁄ (h n ) master donor virus (mdv) for russian laiv by methods of classical reassortment. all attempts to capture avian n neuraminidase into the genome of the mdv laiv production were ineffective. : reassortants were not generated. step by step co-infection of triple reassortants (h n -h n -h n ) with h n mdv in some cases was the only possibility to generate influenza a ⁄ h n cold-adapted vaccine reassortants. difficulties in generating : reassortants could be explained by a substantial gene constellation in the genome of pr based h n reassortant viruses. strong coupling of pb ⁄ pr and avian n genes in a ⁄ h n -pr -rg reassortants was revealed. annually updated laiv strains are generated by classical reassortment of circulating influenza viruses with well characterized, attenuated, ts ⁄ ca mdvs. resulting attenuated reassortants inherit the relevant ha and na of wild type parental virus and six internal genes of the mdv. candidates for inactivated influenza vaccines based upon avian influenza viruses with pandemic potential are generally generated by reverse genetics methods. in these cases, like with laiv, vaccine strains are : reassortants which possess the modified ha and na from potentially pandemic virus and six internal genes from the pr virus. the pr virus is considered to be of low virulence, i.e. attenuated, for humans, yet offers properties of high seed virus growth for influenza vaccine production. the ha of avian h influenza viruses with pandemic potential is engineered to remove four basic amino acid codons from the cleavage site of ha, resulting in a virus that is considered attenuated for natural hosts and safe for people. the objective of this study was to safely generate vaccine candidates for a laiv using highly pathogenic avian influenza viruses by the replacement of six internal pr genes in the genome of candidates for inactivated vaccine subtype h n (a ⁄ h n -pr -rg) with internal genes of the laiv mdv by methods of classical reassortment. len -mdv and a ⁄ h n -pr -rg virus were co-infected in embryonated chicken eggs. five rounds of selective propagation were performed, three of which were at low temperature ( °c). the production and selection of reassortants were carried out in the presence of rabbit antiserum to len -mdv. cloning by endpoint dilution was performed in each of the last three passages. a virus sample in an open petri dish was rocked gently for sec while being irradiated with a ge watt germicidal lamp at a distance of cm from the dish. the residual infection titer was measured by titration in embryonated chicken eggs. genome composition of reassortant viruses was monitored by rflp analysis. in addition, capacity of reassortant viruses to grow at optimum, low, and elevated temperatures (ca ⁄ ts phenotype) for influenza viruses was determined by virus titration in chicken eggs. reassortment of the mdv with the vn-pr or indo-pr viruses either resulted in reassortants that contained six internal genes from len -mdv. however, all generated clones contained the na from the mdv. of ten such : reassortants based on vn-pr three reassortants had the pa gene from pr and one had ns gene from pr . : reassortants from the targeted h n composition were not generated. after repeated attempts, : temperature sensitive and cold adapted reassortants based on vn-pr and indo-pr viruses were obtained, but again, none had inherited the avian n neuraminidase (table ) . in contrast, nibrg- didn't reassort with the mdv at all. twelve unsucsessful attempts to develop : or : reassortants of nibrg- with mdv showed that the classical reassortment procedure (cloning by limited dilutions in the presence of anti-mdv serum, followed by co-infection of equal doses of two parental viruses in eggs and two selective passages at °c) did not work for this virus pair. to disharmonize the incredibly strong gene constellation of nibrg- , various modifications of the co-infection step were studied, such as: altering the nibrg- to mdv ratio (from : to : tions of anti-mdv serum alone or together with anti-pr serum. it was noted that even if the h n to mdv ratio was : , the clones obtained were presumably parental h n viruses without the transfer of any mdv-genes into genome of nibrg- . in all, clones were isolated, and of them were identical to nibrg- parental virus. in nine clones, only the pa gene from mdv was included, whereas in three clones only the 'cold' ns gene was included (data not shown). using uv inactivation of nibrg- prior co-infection was more encouraging. after the first round of co-infection of partially uv-inactivated nibrg- with mdv (at ratio : ), reassortants that inherited several internal genes of mdv were obtained in the context of the nibrg- background (b , c , c , d ) ( table ). some of them (c , c , d ) were chosen for the next round of co-infection. after the second round of co-infection, c , c , and d 'intermediate' reassortants with mdv (at ratio : or : ) : vaccine reassortants finally were obtained. live attenuated influenza vaccine is considered as one of the most promising pandemic vaccines. according to the who there is evidence that laiv might be more effective than inactivated vaccines. this study attempted the safe development of laiv for potential pandemic highly pathogenic avian a ⁄ h n viruses on the base of rg-reassortants for inactivated vaccine with modified h hemagglutinin and mdv for laiv. replacement of pr based internal genes into genome of vn-pr and indo-pr reassortants with appropriate genes of mdv was realized by the classical reassortment procedure. difficulties were encountered in obtaining : reassortants that contained both the ha and na from the wild type avian h n parental virus. in attempts to reassort the nibrg- with mdv, the classical reassortment procedure was unsuccessful. the challenge faced was to break an incredibly strong gene constellation of the nibrg- virus. partial uv-inactivation of nibrg- was encouraged in replacement of some pr internal genes with mdv genes in some cases avian-human reassortant viruses with gull h n and human influenza h n genes were difficult to generate, and reassortants with the desired genotype of six gull virus genes with human influenza a h and n genes were not isolated despite repeated attempts. the gull pb , np, and ns genes were not present in any of the gull-human h n reassortants generated. it is difficult to fully understand potential reasons for observed difficulties to reassort some avian viruses with human strains. unsuccessful attempts to develop : vaccine reassortants may be caused by an observed strong connection of pb and na genes in the genome of a ⁄ h n -pr -rg viruses. in our attempts, each reassortant that possessed avian n neuraminidase inheritied pb gene of pr as well. and vice versa, the 'cold' pb gene always appeared to be coupled with the n neuraminidase of the mdv. in some cases, step by step co-infection of triple reassortants (h n -h n -h n ) with h n mdv may be the only possibility to generate a cold-adapted vaccine reassortant. our studies demonstrate unique and significant challenges that are faced in the development of influenza vaccines for avian influenza viruses with pandemic potential. such challenges must be further studied to identify methodologies to allow for rapid development and response to emerging viruses in a crisis. it is imperative that these studies be continued and expanded to identify either mechanisms of such tight gene constellations in influenza viruses produced by rg-derived vaccine strains or inability some genes of human h n and avian h n viruses to cross. in addition, further studies to improve the efficiency of classical reassortment processes will be conducted. during the period from to , avian influenza outbreaks among humans have been registered in countries of asia, europe, and africa. morbidity and mortality of humans followed the global spread of avian influenza h n among wild and domestic birds, which caused great economic loss to the poultry industry in many regions including some highly developed countries. the global threat from avian influenza forced scientists to develop technologies for the production of a ⁄ h n human vaccine. the development of ai a ⁄ h n vaccines using strains isolated in kazakhstan and the organization of local production and creation of strategic stockpiles of effective vaccines is the an important issue for public health protection in the republic of kazakhstan. to address this, a scientific program 'influenza a ⁄ h n vaccine development for public health protection in kazakhstan' was approved and financed from to . in this article we give basic results of the development of a recombinant ai a ⁄ h n inactivated whole virion vaccine with aluminium hydroxide as adjuvant for public health protection in kazakhstan. [ ] [ ] [ ] the development of vaccine technology was conducted with the use of a ⁄ astanarg ⁄ : ⁄ (a ⁄ h n ) recombinant strain made of a ⁄ chicken ⁄ astana ⁄ ⁄ (h n ) and a ⁄ pr ⁄ ⁄ (h n ) strains by the reverse genetics. inactivation of virus containing allantoic fluid was carried out with the use of formalin in different concentrations. complete-ness of the virus inactivation was tested by -fold virus passaging in embryos. , purification and concentration of the inactivated viruscontaining allantoic fluid was conducted with the use of ultra filtration in tangential flow, which was followed by gel filtration. then we evaluated the content of total protein, hemagglutinin, and ovalbumin in purified and concentrated material. vaccine was composed of clarified and inactivated virus concentrate with the known ha dose containment, and ae % aluminum hydroxide was added in : proportions. composition components and quality control of finished vaccine was determined in the stages of semi-finished product and finished biopreparation. determination of quantitative ovalbumin content was conducted by elisa applying a strip test-system chicken egg ovalbumin elisa kit cat. n (alpha diagnostic international, usa). vaccine immunogenicity was evaluated by hai micro test in u-bottom -well plates produced by 'costar' (usa). vaccine apyrogenicity was evaluated after intravenous injection of the studied preparation to rabbits. , for confirmation of the results vaccine series were tested for bacterial endotoxins with the use of limulus amebocyte lysate produced by charles river laboratories, inc. usa. the vaccine toxicity was evaluated in white mice with body weight - gm and in rats with body weight - g both males and females according to glp principles. allergenic characteristics of the inactivated vaccine was determined in white outbred mice and guinea-pigs both males and females according to 'methodic guideline for evaluation of allergenic characteristics of pharmacological substances'. in the first series of experiments, we conducted work for obtaining influenza a(h n ) recombinant strain. bidirectional expression plasmid phw_b with full-length sequences of ha and na gene segments of the strain a ⁄ chicken ⁄ astana ⁄ ⁄ (h n ) isolated in kazakhstan were synthesized in geneart ag, (regensburg, germany). ha gene was modified by deleting the region encoding multiple basic amino acid rrrk motif in ha cleavage site. moreover, to prevent recovery of repeating basic amino acids motif due to polymerase slide, we inserted replacements g fi t and k fi t. thus the ha cleavage site consists of the following sequence ntpqgerrrkkrglfgai ntpqtetrglfgai. the basic amino acid motif of highly pathogenic strain a ⁄ chicken ⁄ astana ⁄ ⁄ (h n ) was replaced by the sequence tetr ⁄ glf, which is characteristic of low pathogenic strains of influenza h n . sequence of gene coding na in the strain a ⁄ chicken ⁄ astana ⁄ ⁄ (h n ) was cloned without modifications. the other segments pb , pb , pa, np, m and ns were obtained from influenza virus ivr- and synthesized and cloned in two-forked expression plasmid phw_b in geneart ag company, germany. the origin of genetic segments of vaccine strain a ⁄ astanarg ⁄ : ⁄ (h n ) is presented in table . vero cell culture ( passage) (who) was received from european cell culture collection (salisbury, wiltshire sp jg, great britain). the cell culture was grown in dmem ⁄ f medium with the addition of % of fetal bovine serum and mm l-glutamine. to obtain reassortant virus a ⁄ astana ⁄ ⁄ r- : , vero cells were infected with correlative plasmids by way of electroporation using nucleofector ii (amaxa) equipment. infected cells were placed in -well plates. after hour, dmem ⁄ f medium was changed into ml of opti-pro sfm (gibco) medium adding mm l-glutamine and lg ⁄ ml trypsin. two days after cytopathic effect appearance supernatant was collected and used for infection of spf-eggs. the virus a ⁄ astanarg ⁄ ⁄ - : was grown in chicken embryos, and then virus titer was determined in chicken embryos and madine-darby canine kidney (mdck) cell culture. the titer of two final a ⁄ astanarg ⁄ - : virus stocks was ae log eid ⁄ ml (chicken embryos); ae log tcid ⁄ ml (mdck cells); ha titer : . a ⁄ chicken ⁄ astana ⁄ ⁄ (h n ) virus contains motif of repeating basic amino acids in ha cleavage site. it is known that this sequence is the main determinant of ai virus pathogenicity. that is why this site was deleted in vaccine candidate strain. sequence results confirmed that influenza virus a ⁄ astanarg ⁄ ⁄ r- : strain ha gene sequence contains modified ha cleavage site and keeps mutations inserted for prevention of return to virus wild type. to confirm stability of modified ha gene sequence, five additional passages of recombinant strain a ⁄ astana rg ⁄ ⁄ - : were conducted in chicken embryos. sequencing and following phylogenetic analysis of the recombinant strain a ⁄ astana rg ⁄ ⁄ - : ha gene sequence proved the presence of modification in ha cleavage site. deletion of pathogenicity site of the obtained virus was confirmed by lethality test for chicken embryos, intravenous pathogenicity test in chicken, and in plaque-forming test with trypsin. pathogenicity test in chicken embryos showed that recombinant strain a ⁄ astanarg ⁄ - : is capable of growing up to high titers without causing embryos' death. a ⁄ astanarg ⁄ - : strain pathogenicity evaluation was conducted in - week-age white leghorns chicken, and this study proved that the strain a ⁄ astanarg ⁄ - : (h n ) is not virus pathogenicity inductor in chickens, which got intravenous injections of this virus (pathogenicity index is equal to ). h n strain ha cleavage site modification provides its cleavage capability only with tripsin-like proteases, which shows low level of pathogenicity. aiming at confirmation of ha cleavage site modification, we experimentally studied virus replication ability both with trypsin and without this enzyme. and we got the following results. in the plaque-forming test, a ⁄ astanarg ⁄ - : strain produced plaques in mdck cells only with trypsin, proving the trypsin-dependent phenotype characteristic of low pathogenic avian influenza viruses. to prove the ha subtype antigenic analyses of a ⁄ astana ⁄ ⁄ r- : strain was conducted by means of serological methods in hemagglutinin inghibition test with the use of postinfection antisera of rabbits and rats (influenza research institute swd rams), standard serum received from cdc, atlanta, usa. hai test proved that a ⁄ astana ⁄ ⁄ r- : strain belongs to h subtype. furthermore, toxicity of vaccine candidate strain was evaluated by way of subcutaneous injection of viral material to balb mice. the strain appeared to be non-toxic for white mice getting subcutaneous injection of ae ml of the preparation. the conducted research showed that according to all tested characteristics, a ⁄ astana ⁄ ⁄ r- : strain can be used for influenza a ⁄ h n inactivated vaccine production. according to its genetic characteristics, this strain belongs to the group of vaccine strains recommended by who for the development of influenza pre-pandemic inactivated vaccines. we determined basic cultivation parameters of the recombinant strain a ⁄ astanarg ⁄ - : in - day chicken embryos. the determined parameters are the following: infection dose, - eid ; cultivation period, hour; incubation temperature, °c. these cultivation parameters allow obtaining virus containing material with biological eid and hemagglutinating activity of ae - ae log eid ⁄ cm and : ha titre and even higher. in the next series of experiments, we conducted research on the determination of optimal sequence of technological stages of virus clarification, concentration, and inactivation in the order of vaccine production. samples of viral material were subjected to inactivation before and after clarification and concentration. the regimen of virus inactivation by formaldehyde with final concentration of ae %, period of inactivation of days, temperature of inactivation medium of - °c, ph of inactivation medium of - ae . on the basis of the conducted experiments we determined that the selected regimen of inactivation provides complete and irreversible inactivation of viral suspensions of the hpai strain irrespective of the kind of inactivated material. we did not observe reduction of ha activity in non-clarified viral suspensions. however, when we inactivated clarified and concentrated material, ha activity reduced by an order of magnitude. comparison of forms and sizes of virion structural elements in native (non-clarified) and formalin inactivated preparations did not reveal any significant differences. concentration of virus particles in the studied preparations was similar. the selected inactivation regimen provides obtaining completely avirulent viral suspension of the strain a ⁄ astanarg ⁄ - : , and it does not influence the structure of the virus. on the basis of the experiments results, we selected method of viral allantoic fluid inactivation without preliminary clarification. during further research, we tried to get highly clarified viral concentrate. this study resulted in the combined scheme, which includes clarification of inactivated viral allantoic fluid by low speed centrifugation at circulations per min for minutes, filtration through membrane filters with pore diameter of ae lm, ultrafilatration ⁄ diafiltration, gel filtration in b sepharose, and sterilization of viral suspension through membrane filters with pore diameter of ae lm. the experiments resulted in the development of production technology of embryonic inactivated vaccine based on recombinant strain a ⁄ astanarg ⁄ : ⁄ (h n ) contain-ing aluminium hydroxide as adjuvant. the developed influenza a ⁄ h n human vaccine has the trade name kazfluvacÒ. its composition components are presented in table . preclinical testing of the vaccine kazfluvacÒ was conducted according to the following parameters: general health condition of animals, change of body weight and temperature of immunised animals (for ferrets), presence of post vaccination antibodies response in sera, forming protective immune response against reassortant viruses of h subtype, study of acute and chronic toxicity of three experimental vaccine series in different doses and semi-finished vaccine product applying different ways of injection, study of allergic and immunotoxic characteristics of the vaccine, as well as study of pyrogenic reaction and analysis for bacterial endotoxins presence. [ ] [ ] [ ] [ ] preclinical tests of kazfluvacÒ vaccine safety showed that this vaccine does not have toxic effect on organisms of warm-blooded laboratory animals. double intramuscular injection of kazfluvacÒ vaccine in inoculative dose does not effect appearance, general health condition, behaviour of animals, their muscular strength and physical activity, does not have negative effect on biochemical parameters of blood and basic physical functions of animals organism, and does not cause pathomorphological changes. this shows the safety of the vaccine. local irritation action was not observed. the results of the vaccine allergic action study showed that the vaccine does not have allergic effect at the intravenous injection. the research also showed that the vaccine does not have negative effect on immune system of laboratory animals. research conducted on mice and ferrets showed high immunogenic activity of the vaccine at one-and two-dose regimen of injection. the research showed % of protective effect of kazfluvacÒ vaccine at two-dose injection regimen in ferrets infected by homological strain of influenza virus. the devised inactivated influenza a ⁄ h n vaccine kaz-fluvacÒ is a safe and immunogenic biopreparation that is not worse than the overseas analogues in its immunobiological characteristics. [ ] [ ] [ ] [ ] to date the whole-virion inactivated influenza a ⁄ h n vaccines of the producers such as omnivest (hungary), biken, denka seiken, kitasato institute, kaketsuken (japan), gsk biologicals (belgium), sinovac biotech (china) are registered. all of them are produced on the basis of chicken embryos and aluminum is used as an adjuvant. kazfluvacÒ differs from its analogues in the flowchart of the virus purification and concentration that makes possible to produce a safer preparation. , the results of the conducted research and preclinical testing allow starting work towards implementation of phase i preclinical tests on volunteers. it is planned to conduct a randomized blind placebo-controlled phase i study on double application of kazfluvacÒ vaccine in increasing doses. the preparation will be administered to volunteers aged - years for assessment of its safety and immunogenicity in doses of ae and ae lg of ha. when the world health organization (who) announced the sixth phase of a ⁄ h n v influenza pandemic, scientists all over the world started investigation to develop technology for production of prophylactic means against the disease. having taken into consideration the threat of a pandemic for kazakhstan, the ministry of education and science of the republic of kazakhstan launched the program ''monitoring, study, and development of diagnostic, prophylactic, and therapeutic means for influenza a ⁄ h n .'' this paper presents the experimental data obtained at the ribsp in the course of the studies towards the development of technology for production of an inactivated a ⁄ h n influenza vaccine, as well as the results of pre-clinical testing of the developed vaccine. the development of vaccine production technology was conducted with the use of who recommended vaccine strain nibrg- xp constructed by the method of reverse genetics in the national institute for biological standards and control (nibsc, great britain). the virus was inactivated with formalin at different final concentrations, and the extent of inactivation was evaluated via threefold virus passages in developing chicken embryos. the inactivated virus was purified and concentrated by the method of ultrafiltration in tangential flow followed by gel filtration. the purified and concentrated material was evaluated judging on the total protein, hemagglutinin (ha), and ovalbumin. the vaccine was prepared by pooling the purified and concentrated virus material with the certain weight content of ha and the work solution of aluminum hydroxide ( ae %) in the ratio : . the ovalbumin content was quantified in elisa with the use of the strip test system chicken egg ovalbumin elisa kit (cat. no. alpha diagnostic international, san antonio, texas, usa). weight content of the virus ha was determined according to sominina, burtseva. the content of the residual formaldehyde, aluminum (al + ) ions, and thiomersal in the vaccine was measured according to the operating instructions. the vaccine immunogenicity was assessed in the hemagglutination inhibition test, which was carried out as a microassay in -welled u-bottomed plates (''costar'', new york, usa). , apyrogenicity of the vaccine was assessed post intravenous administration of the tested preparation to rabbits. , to confirm the obtained results the vaccine batches were tested for bacterial endotoxins with use of the limulus amebocyte lysate (charles river laboratories, inc., wilmington, ma, usa). the toxicity of the vaccine was assayed in white mice weighing - g and in rats weighing - g (male and female) in compliance with the principles of good laboratory practice. allergenic properties of the inactivated vaccine were determined according to the ''operating instructions on assessment of allergenic properties of pharmaceutical substances'' in white outbred laboratory mice and guinea-pigs of both sexes. the first step in the course of developing technology for vaccine production was to determine the major conditions for influenza virus cultivation: usage of -days embryonated chicken eggs at the infectious dose within - eid , incubation temperature ( ± ae )°c, and duration of the incubation period hours. the established parameters for virus cultivation made it possible to produce virus-containing materials of infectious activity within ae - ae log eid ⁄ cm and hemagglutinating activity : and higher. in the subsequent experiments, an optimal method for virus inactivation was selected. on the basis of the experimental findings, the following conditions for inactivation of the native virus-containing material were elected: formalin of ae % final concentration as an inactivating agent; inactivation period of hours at temperature ( ± )°c. these conditions provide the complete inactivation of the virus (nibrg- xp strain) material, did not impact distinctly the structural organization of the virus, and did not reduce the antigenic activity. as it is well known, virus purification and concentration means very much in the development of technology for production of an inactivated whole-virion influenza vaccine. the investigation into optimization of the technological step of purification and concentration of the recombinant influenza virus nibrg- xp strain resulted in selection of an optimal pattern including such steps as clarification of the virus suspension by filtration through membranes with pore size ae lm, virus concentration by ultrafiltration in a tangential flow, dialysis filtration in a tangential flow, gel filtration on sepharose b, and sterilization of the viral suspension through membrane filters with pore size ae lm. the studies conducted by the ribsp specialists resulted in the development of technology for production of the first domestic whole-virion inactivated a ⁄ h n influenza vaccine with aluminum hydroxide as adjuvant and with the brand name refluvac Ò . the key processing characteristics of the whole-virion inactivated a ⁄ h n influenza vaccine vaccine refluvac Ò are shown in table . simultaneous with the performance of all process operations, the parameters such as sterility, inactivation extent, ph, vaccine specificity, total protein content, weight content of has, aluminum and formalin contents, content of thiomersal, and ovalbumin, pyrogenicity of the vaccine and its immunogenicity for mice, were optimized. the key qualitative characteristics of the designed influenza a ⁄ h n vaccine refluvac Ò are shown in table . before implementation of phase i clinical trials on volunteers, preclinical testing of three experimental batches of refluvac for immunogenic activity and safety was carried out. it was conducted in three laboratory bases of research institutions: the toxicology institute ⁄ federal medicobiological agency, russia (st petersburg), the research institute for biological safety problems (republic of kazakhstan), and the influenza research institute ⁄ north-western branch of the russian academy of medical sciences (st petersburg), with use of different animal models (mice, rats, chinchilla rabbits, guinea-pigs, ferrets). the results of the preclinical testing are as follows: • electron microscopy of the preparation has shown that the viral particles are well dispersed and do not aggregate. the portion of whole (intact) particles is over %, which is evidence of virion integrity; • assessment of polypeptide composition of the vaccine refluvac by electrophoresis in % polyacrylamide gel with sodium dodecyl sulfate has shown the vaccine to contain both surface antigens (ha, na) and highly purified inner virion proteins (np, m ) that are typespecific antigens, so the vaccine is a preparation of full immunological value; • judging on the parameters of acute and chronic toxicity for white mice and rats of both sexes, the vaccine is a non-toxic and safe preparation; • under conditions of a chronic experiment on white mice and rats, it was found that refluvac does not produce changes in behavior, somatic, or vegetative responses; • assay of hematological and biochemical blood characteristics of white mice and rats following vaccine administration did not reveal any significant differences as compared to the animals of the control group; • refluvac does not cause allergenic and immunotoxic impact; • the vaccine refluvac does not cause local irritative effect; • refluvac is apyrogenic for laboratory animals; • the pathomorphological and hystopathological analysis did not reveal any changes due to immunization in animal organs; • testing of immunogenic characteristics of the vaccine on mice and ferrets has shown formation of hemagglutinating antibodies in animals after single administration; • refluvac induces % protection in immunized ferrets at their challenge with the wild-type influenza virus a ⁄ california ⁄ ⁄ (h n v). the results of the performed preclinical testing have allowed concluding that refluvac, an inactivated whole-virion vaccine with aluminum hydroxide as adjuvant, is a safe and highly effective preparation against influenza a ⁄ h n v. the implemented study resulted in development of technology for production of the first domestic inactivated allantoic whole-virion influenza a ⁄ h n vaccine with aluminum hydroxide as an adjuvant under the brand name refluvac Ò based on the recombinant strain nibrg- xp. the devised pandemic vaccine meets who requirements as well as requirements concerning safety and immunogenicity of the national pharmacopeias of the republic of kazakhstan and russian federation. [ ] [ ] [ ] [ ] the devised technology for vaccine production differs from the previous technologies for production of allantoic whole-virion influenza a ⁄ h n vaccines in its processdependent parameters. presence of an adjuvant (aluminum hydroxide) increases significantly the vaccine immunogenicity and allows maximal reduction of the dose of the administered antigen that, in turn, results in diminished reactogenicity of the vaccine. aluminum hydroxide is an adjuvant that is most frequently used in clinical practice. to date the results of the double-centered randomized study of the europe-licensed vaccine fluval p [monovalent inactivated whole-virion influenza vaccine with aluminum phosphate based on strain a ⁄ california ⁄ ⁄ (h n ) nymc x- a (omninvest, pilisborosjeno, hungary)] that is similar to the refluvac preparation are published. the data of this research are an evidence of safety and high immunological effectiveness of the vaccine in dose lg ha at single administration both in adults and elderly persons. the results of the pre-clinical tests allow recommending carrying out phase clinical testing of the refluvac Ò vaccine for safety and immunogenicity. single immunization of volunteers with refluvac Ò in doses ae , ae , and ae lg of ha are planned. mid , respectively. the study results confirm that new h n laiv and h n laiv candidates are safe and immunogenic and confer protection from homologues influenza virus infection in mice. the recent emergence of a new pandemic h n virus and the threat of transmission of avian viruses to humans had stimulated research and development of live attenuated cold-adapted influenza vaccines against newly appeared influenza viruses. formulations of live attenuated influenza a vaccine (laiv) against pandemic influenza strains, including h n , h n , h n , and h n are currently being tested in preclinical and phase i clinical studies. the following paper describes the preclinical study of new h n and h n laiv candidates in mice. the study addressed the following three objectives: (i) to demonstrate that cold-adapted (ca) reassortant influenza a(h n ) and a(h n ) vaccine candidates are indistinguishable from the parental a ⁄ leningrad ⁄ ⁄ ⁄ (h n ) master donor strain (mds) virus with regard to replication efficiency in upper and lower respiratory tract of mice; (ii) to demonstrate the immunogenicity of different doses of cold-adapted (ca) reassortant influenza a(h n ) and a(h n ) vaccine candidates in mice; and (iii) to demonstrate the protective efficacy of cold-adapted (ca) reassortant influenza a(h n ) and a(h n ) vaccine candidates in mice against a homologous wild-type virus challenge. the a ⁄ ⁄ mallard ⁄ netherlands ⁄ ⁄ (h n ) reassortant containing the ha and na genes from a ⁄ mallard ⁄ netherlands ⁄ (h n ) and six other genes from mds, the a ⁄ ⁄ california ⁄ ⁄ (h n ) reassortant containing the ha and na genes from a ⁄ california ⁄ ⁄ (h n ) and six other genes from a ⁄ leningrad ⁄ ⁄ ⁄ (h n ) were generated by classical genetic reassortment in embryonated chicken eggs (ec). viruses were propagated in days old eggs ( °c, hours). fifty percent egg infectious dose (eid ) titers were determined by serial titration of viruses in eggs. titers were calculated by the method of reed and muench. female balb ⁄ c mice, - weeks of age were used in all experiments. mice were lightly anesthetized with ether and then inoculated intranasally (i.n.) with ll of infectious virus diluted in phosphate-buffered saline (pbs). mice were inoculated with mid ( % mouse infectious dose) of a ⁄ ⁄ california ⁄ ⁄ (h n ), a ⁄ ⁄ mallard ⁄ netherlands ⁄ ⁄ (h n ), and a ⁄ leningrad ⁄ ⁄ ⁄ (h n ) mds. viral loads were measured in respiratory and brain tissues collected at and days post-infection (dpi). tissue homogenates prepared using a disruptor and clarified supernatants were titrated on eggs at permissive temperature to determine infectious concentrations. groups of animals were inoculated with mid or mid of either h n laiv or h n laiv intranasally after collecting a pre-immunization blood sample. a second blood sample was collected at dpi. on the same day, the animals received a second intranasal inoculation with the same virus that was used for priming at dpi. to assess protection, all animals were infected dpi with either mid of a ⁄ california ⁄ ⁄ (h n ) or mid a ⁄ mallard ⁄ netherlands ⁄ (h n ) virus by the intranasal route. four animals from each group were euthanized at dpi, and the respiratory and systemic organs were harvested for virus titration. a forth blood sample was collected at dpi from the remaining animals. hi antibody titers were determined for individual serum samples collected on days , , , and . body weights were taken daily following challenge through day postchallenge. sera were tested for hi against homologous h n and h n viruses. the h n laiv, h n laiv and h n mds influenza viruses replicate in mice lungs at level ae - ae lgeid ⁄ ml at dpi (figure ). at dpi, replication of the viruses in the lungs decreased to ae - ae lgeid ⁄ ml (data not shown). in contrast, the wild-type virus a ⁄ mallard ⁄ netherlands ⁄ (h n ) demonstrated high level replication in lungs - ae lgeid ⁄ ml. the levels of replication of studied viruses in nasal turbinates were ae - ae lg eid ⁄ ml at dpi (figure ) , and ae - ae lgeid ⁄ ml at dpi (data not shown). there were no significant differences between the viruses in regard to replication in upper respiratory tract of mice. thus, it was shown that a ⁄ ⁄ mallard ⁄ netherlands ⁄ ⁄ (h n ) and a ⁄ ⁄ california ⁄ ⁄ (h n ) vaccine candidates was indistinguishable from parental a ⁄ leningrad ⁄ ⁄ ⁄ (h n ) in terms of replication in the lungs and noses of mice at and dpi. no virus was found in the brain tissue of immunized mice at and dpi (in undiluted samples tested). thus, it was shown that a ⁄ ⁄ mallard ⁄ netherlands ⁄ ⁄ (h n ), a ⁄ ⁄ cali-fornia ⁄ ⁄ (h n ) vaccine candidates are identical to a ⁄ leningrad ⁄ ⁄ ⁄ (h n ) in lacking neuroivasive capacity, and all three viruses similarly fail to replicate in the brain. it was shown that all immunized animals survived after challenge with wild-type a ⁄ mallard ⁄ netherlands ⁄ ⁄ (h n ) virus. the mice in vaccine groups showed no signs of morbidity. average weight changes were tracked from day to day in all study groups, but the changes did not exceed %. as shown in figure , the challenge virus actively replicated in respiratory tissue taken from mock immunized animals ( ae lgeid in the lung and ae lgeid in the nose), but failed to infect the brain and spleen. on the other hand, in both h n laiv vaccinated groups, all tested organs were free from presence of challenge virus. thus, immunization of mice with either mid or mid h n laiv protected the animals from the subsequent challenge infection with a homologous with wild-type h n virus. both h n and h n laiv candidates were found to be immunogenic. after one dose of mid of h n laiv, gmt of hi antibodies were ae . one dose of mid or mid h n laiv elicited hi antibody level with gmt of ae and ae , respectively. the second dose of h n laiv further stimulated serum hi antibody levels to gmt ae and ae , for mid or mid , respectively (data not shown). the mouse model is widely used to better understand the pathogenicity of avian influenza viruses for mammalian species, to be able to predict the pandemic potential of such viruses, and to develop improved methods for the prevention and control of the virus in a potential pandemic. a subset of the h viruses was evaluated for the ability to replicate and cause disease in balb ⁄ c mice following intranasal administration. h subtype viruses were able to infect mice without adaptation and manifested different levels of lethality and kinetics of replication. there is limited preclinical information available for laiv. thus, live monovalent vaccine against pandemic influenza virus h n (influvir) was tested for acute toxicity and its effect on the systems and organs of laboratory animals. according to toxicology and necroscopy results, the live monovalent influenza vaccine influvir, when applied intranasally, was safe and was well tolerated. in our current study we demonstrate that a(h n ) and a(h n ) laiv are indistinguishable from the parental mds virus with regards to replication kinetics in the upper and lower respiratory tract of mice. both h n and h n laiv candidates were immunogenic and protect mice against subsequent a challenge with the wild-type virus. live attenuated cold-adapted (ca) influenza vaccines are an effective means for the control of influenza, most likely due to their ability to induce both humoral and cellular immune responses. in our study we confirm that new h n laiv and h n laiv candidates are safe, immunogenic, and confer protection from influenza infection in mice. health organization (who) declared a pandemic by raising the worldwide pandemic alert level to phase . therefore, h n inactivated monovalent vaccine formulated with our proprietary oil-in-water emulsion based adjuvant was evaluated in ferrets for its potential to induce with low antigen dose efficient, robust, and rapid protective immunity against a wild type challenge virus (a ⁄ netherlands ⁄ ⁄ ). this adjuvant was also tested in ferrets in a h n avian influenza model for its ability to induce a cross-clade immunity and cross-protection. two independent studies (a&b) were carried out with male and female outbred ferrets (musleta putorius furo) in compliance with ''guide for the care and use of laboratory animals,'' ilar recommendations and aaalac standards. ferrets used in both studies were influenza seronegative by anti-nucleoprotein elisa and by hi assay against the pandemic and seasonal strains. in study a, four groups of seven ferrets aged approximately of months received one or two im vaccinations weeks apart of either af -adjuvanted ( ae lg of ha with af ) or unadjuvanted ( body weight loss was monitored as an indicator of disease and a mean body weight loss of % was recorded in the control group at day of necropsy. body weight loss was reduced to £ % and £ % in animals that had received and doses of either unadjuvanted or af -adjuvanted vaccine, respectively. viral lung titration showed high levels of virus replication ( ‡ ae tcid ⁄ g tissue) in the lungs of all control ferrets days after challenge. one or two administrations of unadjuvanted vaccine reduced lung viral load by and log , respectively. interestingly, ferrets that received either one or two doses of af -adjuvanted h n vaccine, showed significantly greater reduction of lung viral loads (> log ). no virus was detected in the lungs of ⁄ ( %) animals immunized with a single injection of the af -adjuvanted vaccine and in % of ferrets vaccinated twice. assessment of viral shedding from the upper respiratory tract showed that the af -adjuvanted a ⁄ h n monovalent vaccine was able to reduce the viral load in the nose and in the throat by ae and ae log , respectively, as compared to the control group. conversely, viral loads were only slightly reduced in the nose and mostly unchanged in the throat in ferrets immunized with either one or two doses of unadjuvanted a ⁄ h n monovalent vaccine. gross pathology and histology examinations revealed lung lesions consistent with influenza a ⁄ h n virus infec- however, a second dose of af -adjuvanted vaccine strongly increased hi and mn titers, which persisted for months (table ). antibody responses cross-reactive to heterologous clade . strain were elicited ferrets vaccinated with the af -adjuvanted clade . vaccine. hi antibody titers ‡ crossreactive to clade . and persistent up to d were observed in vaccinated animals. an inter-clade low crossreactive hi response to a clade strain was only detected in a few ferrets that had been vaccinated with the af -adjuvanted clade . . all af -adjuvanted clade . antigen vaccinated animals survived challenge either with the homologous or heterologous virus until euthanized day . after challenge, mean body temperature and mean body weights were monitored as indicators of disease. in the control ferrets, mean body temperature increased by - °c (depending on the challenge virus strain) h post challenge, with an accompanying mean body weight loss ranging from ae % to ae %. ferrets vaccinated with the af -adjuvanted clade . vaccine showed a lower and delayed fever compared to control ferrets that received the same viral challenge, whereas no significant differences were observed between vaccinated animals and their respective controls upon challenge with clade . or clade viruses. body weight loss was reduced in all vaccinated animals when compared to controls after challenge with either the homologous clade . strain or with one of the heterologous strains. lung virus titration showed high levels of virus replication in all control animals days after homologous challenge with the clade . virus. lung viral loads of all ferrets immunized with the af -adjuvanted clade . vaccine were reduced more than log . vaccination resulted in complete viral clearance from the lungs of % of animals assessed days after challenge. as compared to controls, a reduction of the mean viral load of about log was observed in ferrets vaccinated with the af -adjuvanted clade . vaccine after heterologous challenge with either the clade or clade virus. conversely, vaccination with af -adjuvanted clade . vaccine did not result in reduction of lung viral loads after challenge with the clade . heterologous virus strain. titration of pharyngeal swabs showed high levels of viral shedding in all control ferrets after challenge with clade . strain, whereas virus was not detected in any vaccinated animal. similarly, log reduction of viral shedding was seen in vaccinated versus control ferrets following clade heterologous challenge. lower reductions in viral shedding were observed after clade . challenge ( ae log ) and clade challenge ( ae log ). gross pathology and histology revealed lung lesions consistent with influenza a ⁄ h n virus infection all control animals challenged with the clade . , clade . or clade strains. mild to moderate lung lesions were observed in control animals following challenge with clade virus. macroscopic evaluation (percentage of affected lung parenchyma) and histopathological analysis (extent and severity of alveolitis, alveolar oedema and hemorrhage) showed that lung lesions were significantly reduced in af -adjuvanted clade . vaccinated animals after challenge with the homologous clade . virus strain as compared to controls. similarly, a reduction of the macroscopic and microscopic lung lesions was observed in vaccinated animals upon heterologous challenge with clade . and clade virus strains, whereas no differences were observed between control and vaccinated animals after challenge with clade virus. the results of these ferret challenge studies demonstrated that low doses of pandemic influenza vaccines formulated with an oil-in-water emulsion adjuvant, af , elicited strong antibody responses specific to the immunizing strain. importantly, these vaccines provided protection after homologous challenge with complete virus clearance in ferret lungs and reduced viral shedding from the upper respiratory tract suggesting an ability to reduce virus transmission. moreover, af -adjuvanted h n vaccine can provide cross-protection upon challenge with different h n clades by preventing mortality and reducing the viral burden in the lower and the upper respiratory tract. in conclusion, the results of these studies highlighted the ability of af -adjuvanted influenza vaccines to induce potent immune responses and full protection in ferrets against homologous challenge and suggested that protection may be mediated, at least in part, by antigenspecific humoral immunity. since , outbreaks of h n influenza virus infection in poultry have occurred in eurasian countries. phylogenetic and antigenic analysis of h n isolates revealed that there are three sublineages, consisting of g , g , and korean, among ha genes of the eurasian h n viruses. h n viruses do not cause severe disease in poultry, but co-infection of h n viruses with bacteria such as staphylococcus aureus, haemophilus paragallinarum, or attenuated coronavirus vaccine may exacerbate the disease. , h n viruses were isolated from domestic pigs in china and korea and from humans with febrile respiratory illness in hong kong in kong in , kong in , and it is, thus, postulated that in the present study, h virus strains were analyzed antigenically and phylogenetically to select a proper h n vaccine strain. inactivated whole virus particle vaccine was prepared, and its potency against h virus challenge was assessed in mice. viral rnas were extracted from the allantoic fluid of chicken embryos infected with viruses by using a commercial kit (trizol ls reagent; invitrogen, california, usa) and reverse-transcribed with the uni primer and m-mlv reverse transcriptase (invitrogen). the primers used for the ha gene amplification were h - f and h - r. for phylogenetic analysis, sequence data of the genes together with those from public database were analyzed by the neighbor-joining method. h influenza viruses were analyzed by hemagglutinationinhibition (hi) test. chicken hyperimmunized antisera against seven h viruses were prepared according to previous report. virus replication and pathogenicity against embryonated chicken eggs viruses were inoculated into -day-old embryonated chicken eggs and incubated for hours at °c. ha titers and % egg infectious dose (eid ) were measured every hours post-inoculation. pathogenicity of dk ⁄ hok ⁄ ⁄ against embryonated chicken eggs was evaluated by mean death time (mdt) as described previously. dk ⁄ hok ⁄ ⁄ was injected into the allantoic cavities of -day-old embryonated chicken eggs and propagated at °c for hours. the virus in the allantoic fluids ( ha) was purified by differential centrifugation and sedimentation through a sucrose gradient according to previous report. the concentration of protein was measured by od using ultrospec pro (amersham biosciences, tokyo, japan). the purified virus was inactivated with ae % formalin at °c for days. immunization of mice and challenge of immunized mice with hk ⁄ ⁄ four-week-old female balb ⁄ c mice were purchased from japan slc, inc. (shizuoka, japan). the mice were injected subcutaneously with , , ae , or ae lg proteins of inactivated dk ⁄ hok ⁄ ⁄ whole virus vaccine. two weeks later, the mice were boosted by subcutaneous injection with the same dose of the vaccine. control mice were injected with pbs. serum samples were tested by enzyme-linked immunosorbent assay (elisa) according to previous report. one week after the second vaccination, mice in each group were challenged intranasally with ll of ae eid of hk ⁄ ⁄ under anesthesia. on days postinfection, five mice in each group were sacrificed, and the lungs were separately homogenized to make a % (w ⁄ v) suspension with minimal essential medium (nissui, tokyo, japan). the virus titers of the supernatants of lung tissue homogenates were calculated in -day-old embryonated chicken eggs and expressed as the eid ⁄ gram of tissue. the other five mice in each group were monitored for body weight for days after challenge. the ha genes of h viruses were sequenced and analyzed by the neighbor-joining method. all of the h viruses were classified into the eurasian lineage ( figure ) . eleven, seven, and four strains were classified in the korean, g , and g sublineages, respectively. the h viruses of the korean and g sublineages were isolated from waterfowl, poultry, pigs, and humans in the east asian countries, and those of the g sublineage were isolated from poultry in the west asian countries. the cross-reactivity between these antisera and h n viruses were analyzed by hi test. the antisera against h viruses belonging to the korean sublineage were broadly cross-reacted to h viruses belonging to the g and g sublineages. h viruses belonging to the korean lineage were reacted to the antisera against h viruses belonging to the g and g sublineage compared with h viruses belonging to the other sublineage (data not shown). thus, it was suggested that h vaccine strain should be selected from the viruses of korean sublineage to prepare for the vaccine strain of h viruses. dk ⁄ hok ⁄ ⁄ replicated efficiently in -day-old embryonated chicken eggs (data not shown). pathogenicity of dk ⁄ hok ⁄ ⁄ against embryonated chicken eggs was determined by mdt. dk ⁄ hok ⁄ ⁄ was low pathogenic against embryonated chicken eggs (data not shown) and was selected as an h vaccine strain. to assess the potency of the vaccine against h virus infection, mice vaccinated subcutaneously with inactivated dk ⁄ hok ⁄ ⁄ were challenged intra-nasally with hk ⁄ ⁄ . immunogenicity of the inactivated vaccine was assessed by measuring the igg antibodies in mouse sera by elisa. antibody was detected in the group of mice injected lg protein after the first immunization and detected in the group of mice injected lg protein after the second immunization. thus, potency of the present inactivated whole virus vaccine was demonstrated in mice. next, to assess the protective immunity of the inactivated vaccine in mice, viral titers in the lungs was determined. the virus titers in the lungs were ae - ae eid ⁄ g in the groups of mice injected , and lg protein, and ae - ae eid ⁄ g in the other vaccinated groups. body weight reduction of mice were observed in the group of mice injected ae , ae lg protein, and control groups from dpi, and reached to % body weight loss from -to -day post-infection ( figure ). this result correlates with antibody titer in mouse sera and viral titers in the lungs. these results suggest that the test h inactivated whole vaccine confers prevent of weight loss and reduction of virus replication against h influenza virus infection in mice. recently, h n viruses of all of three sublineage have been isolated from wild birds and poultry in worldwide. h n viruses were isolated from pigs and humans in china and korea, suggesting that h n virus would be a potential for a pandemic influenza virus in human population. h n viruses were isolated from pigs in china and korea and were classified into the g and korean sublineage. in human cases, all h n virus isolated from humans in china was classified into the g sublineage. it was suggested that h n viruses isolated from pigs and humans vary in antigenicity of isolates between the korean, g , and g sublineages. therefore, it is important for the preparedness of influenza pandemic to develop h influenza virus vaccine, which could broadly cross-react to antisera of all sublineage viruses. so, we selected the vaccine candidate strain, dk ⁄ hok ⁄ ⁄ , which could broadly cross-react to antisera of all sublineage viruses, and which could replicate in this study, it was suggested that the test vaccine has potency to protect against challenge with h virus using mice for mammalian model. the challenge virus, hk ⁄ ⁄ , was isolated from human, replicates efficiently in mice, and shows pathogenicity in mice. the test vaccine inhibited viral replication and body weight loss in mice. whole inactivated vaccine produced protective immunity, supporting our approach of using whole virus particles for vaccine development. furthermore, whole particle virus vaccine could induce igg and mucosal iga levels after intranasal vaccination with whole particle vaccine. the present results may facilitate the studies of the vaccine for future pandemic caused by h influenza virus in humans. tants to attempt to improve growth. to determine whether wild type h n pdm grew better in the novartis mdck suspension cell line (mdck pf) than in eggs, isolations from h n pdm positive clinical samples were attempted in both substrates. the isolation rate of h n pdm viruses was higher in mdck pf cells ( %) ( ⁄ ) compared to allantoically inoculated eggs ( %) ( ⁄ ) . however the yields were lower than observed with seasonal viruses. little improvement in virus yield was seen with extra passaging or dilutions of h n pdm viruses isolated in mdck pf cells. with the emergence of the swine-origin pandemic h n (h n pdm) influenza in april , the need for efficient production of a suitable vaccine was a high priority. virus isolates were distributed by the who for the urgent development of suitable vaccine strains early in the pandemic. vaccine viruses can be grown in embryonated chicken eggs or in certified mammalian cells. , unfortunately wildtype h n pdm virus strains distributed by the who grew poorly in cell lines and eggs, requiring the generation of a series of conventional and reverse genetics derived reassortants to attempt to improve growth. from these reassortants, only the conventional egg derived reassortants nymc-x- a and nymc-x- (both based on one of the earliest known viruses a ⁄ california ⁄ ⁄ ) showed high enough growth and yield in eggs and cell culture to make them suitable for vaccine manufacture. these reassortants, while acceptable, still only gave haemagglutinin (ha) yields of approximately % that of seasonal h n reassortants. to determine if more recent wild type h n pdm viruses grew better in the novartis mdck suspension cell line (mdck pf), h n pdm positive clinical samples were cultured in mdck pf cells and also in embryonated hen's eggs. in addition, to improve virus yields from mdck pf isolates, extended passaging of three wild type h n pdm influenza viruses was performed using various virus dilutions at each passage level. the results were assessed using various serological and molecular biology techniques and compared to viruses isolated in eggs and conventional mdck cells. h n pdm viruses were received at the centre from who national influenza centres, who influenza collaborating centres and other regional laboratories and hospitals in australia, new zealand, and the asia ⁄ pacific region. viruses were received as original clinical specimens consisting of nasal swabs, throat swabs, nasopharyngeal aspirates, or nasal washes that had previously been shown to be h n pdm positive by real time rt-pcr. these specimens were then cultured in mdck pf cells with serum free medium containing trypzean (optaflu) and also independently inoculated into the allantoic cavity of day-old embryonated hen's eggs. virus cultures in mdck pf cells were sampled at and hour and evaluated by various means including ha titres. at hour, virus cultures were further passaged at varying dilutions ranging from ) to ) up to a total of passages. embryonated hen's eggs were incubated at °c for days and allantoic fluid was harvested and ha titres performed to determine whether a further passage was required in order to improve growth. the conventional reassortants were produced by a mixed infection of eggs or mdck pf cells with the wild type virus and a donor virus carrying the internal genes of the a ⁄ puerto rico ⁄ ⁄ virus. the reassortants were obtained by sequential passages using immuno-selective antisera against the surface antigen of the donor virus to remove virus populations carrying the ha and na protein of the donor strain. the reverse genetics viruses were rescued in vero cells using the plasmid system. both types of reassortants were generated and supplied by who collaborating centres and essential regulatory laboratories except the nvd-c- strain, which was produced by novartis. in this small study with recent h n pdm viruses, the isolation rate was higher in mdck pf cells ( %) ( ⁄ ) compared to allantoically inoculated eggs ( %) ( ⁄ ) . assessment of ha titres, however, showed higher ha titres in egg-isolated viruses compared to viruses isolated in mdck pf cells after two passages. egg generated or cell generated reassortant viruses gave higher ha titres compared to the homologous wild type viruses (table ) . no amino acid changes were observed in mdck pf isolated influenza viruses compared to original specimens or viruses isolated in conventional atcc derived mdck cells, unlike egg isolated viruses which showed a number of amino acid changes, many consistent with egg adaptation mutations (table ) . viruses isolated in mdck pf cells grouped phylogenetically with viruses isolated in conventional atcc derived mdck cells or viruses sequenced from original clinical samples, while egg isolated viruses grouped slightly differently (data not shown). as a result of the poor growth of h n pdm viruses in mdck pf cells, serial dilutions were performed over a number of passages ( figure ). based on the results obtained from the virus isolates, a ⁄ victoria ⁄ ⁄ , a ⁄ wellington ⁄ ⁄ , and a ⁄ darwin ⁄ ⁄ , a supplemental protocol was developed and used in the isolation of a ⁄ brisbane ⁄ ⁄ (figure ). only small differences in ha titer were seen between different dilutions, and copy number showed a similar trend to ha titer at each passage ( figure ). following the supplemental protocol for the isolation of a ⁄ brisbane ⁄ ⁄ results showed slightly higher ha titres with little variation between passages. the egg derived reassortants nymc-x- a and nymc-x- were also assessed for growth in mdck pf cells and were found to be superior by ha titer to other conventional reassortants (egg or cell derived), reverse genetics derived reassortants, or wild type viruses (table ) . two methods were used to determine the ratio of ha to other viral proteins: densiometric analysis using sds-page and reversed-phase hplc using a subtype specific standard. ha content in different vaccine seeds of influenza a subtypes demonstrated that the ha content per total virus protein from the nymc h n pdm reassortants was significantly different to the seasonal influenza a subtypes. for the seasonal h n the ratio of ha to p p p p p p p p p p p p p p p p n and m was ‡ %, for the h n the ratio of ha to n and m was £ %, while for the pandemic a ⁄ h n , the ratio of ha to n and m was much lower at £ % (data not shown). the results of this study has observed the growth of a series of - h n pdm viruses in vaccine suitable mdck pf cells to be generally lower than what has been seen with other seasonal influenza viruses. little improvement in virus yield was seen with extra passaging of h n pdm viruses isolated and passaged in mdck pf cells. passaging up to times in mdck pf cells using dilutions ranging from ) to ) resulted in supernatants with viral ha titres ranging from ha ⁄ ll to ha ⁄ ll. the isolation rate of h n pdm viruses was higher in mdck pf cells ( %) compared to allantoically inoculated (and passaged) eggs ( %), a trend also seen in previous work with seasonal influenza viruses. in contrast a study by hussain and colleagues found similar rates of isolation and replication of seasonal influenza viruses in mdck cells and eggs. the virus load as determined by matrix gene copy number showed a similar trend to ha titers. two of the isolates exhibited small rises and falls in ha titer during passaging, while a third, a ⁄ victoria ⁄ ⁄ gave consistently higher titers. interestingly this virus was unable to be isolated in eggs. the ha sequences of all strains were assessed at p , p , p , p , p and when available compared to the original clinical sample ha sequence. mdck pf-isolated viruses had few if any changes in their ha amino acid sequence, while the majority of egg isolates showed - amino acid changes compared to the clinical sample, with an egg adaption change (l i) evident in a number of them. the ha sequence of one of the better growing viruses, a ⁄ victoria ⁄ ⁄ , was found to have a g e change compared to the a ⁄ california ⁄ ⁄ reference virus. this change was also seen in the virus isolated in conventional, adherent mdck cells. these viruses with g e change when tested by hai have shown reduced reactivity with ferret antisera to a ⁄ california ⁄ ⁄ -like viruses, but normal reactivity with ferret antisera to h n pdm a ⁄ bayern ⁄ ⁄ -like viruses. despite this mutation all mdck pf derived viruses appeared to be a ⁄ california ⁄ ⁄ -like by hai. the h n pdm egg-derived reassortants (nymc x- a and nymc x- ) when grown in mdck pf cells were superior to wild type h n pdm viruses, reverse genetics derived reassortants, and other egg-derived reassortants. the yields of haemagglutinin from the nymc h n pdm reassortants were still below those seen with sea-sonal h n reassortants as was also seen in eggs. this trend has also been noted in other studies. in summary, attempts to improve growth and yield of the h n pdm wild types for mdck pf cells by extended passaging were not successful, and reassortants did not perform as well as seasonal h n reassortants have in the past. however, using higher dilutions for the passaging of h n pdm viruses in mdck pf cells did result in higher ha titres (a ⁄ brisbane ⁄ ⁄ ). further work is therefore required to generate pandemic h n seed viruses that grow well in a variety of cell culture and egg based vaccine production systems. the aim of this study is to evaluate antibody response to influenza virus neuraminidase (na) following immunization with live attenuated influenza vaccine (laiv). we adjusted the peroxidase-linked lectin micro-procedure previously reported by lambre, et al. ( ) to assay neuraminidase inhibition (ni) antibody in sera taken from immunized mice and from human subjects in a clinical trial. for the assay, we prepared the a(h n ) reassortant virus containing the na of a ⁄ california ⁄ ⁄ (h n ) and the hemagglutinin (ha) of a ⁄ equine ⁄ prague ⁄ ⁄ (h n ). in addition, we used an na-specific igg elisa assay to test sera from immunized mice and volunteers. in mice, one dose of laiv induced ni antibody of a geometric mean titer (gmt) of ae , compared to ae in the control group. gmt of ni from human subjects who received two doses of pandemic a(h n ) were significantly higher than pre-vaccination titers. in unvaccinated human subjects, na-specific cross-reactive antibodies to pandemic a(h n ) were detected more often than cross-reactive antibodies to ha. antibody response to influenza virus na contributes to the overall immune response to influenza and may provide partial protection against influenza infection and reduce severity of disease in the host. a number of preclinical studies using purified or recombinant na have shown that various two-dose vaccine regimens in mice may significantly reduce pulmonary virus titers following viral challenge. [ ] [ ] [ ] a plasmid dna-vaccine model demonstrated cross-reactive antibodies to human n in mice could provide partial protection against a lethal challenge against h n or recombinant pr bearing the avian n . immunogenicity of current influenza vaccines, including laivs, is measured primarily as a level of strain-specific hemagglutination inhibition (hi) antibodies. however, the who meeting on the role of na in inducing protective immunity against influenza infection ( ) specified a need to develop suitable assays for anti-na antibody detection to enhance influenza vaccine evaluation in preclinical and clinical studies. the aim of the current study was to evaluate anti-na antibodies to pandemic a(h n ) influenza virus following laiv immunization. the rn ⁄ -swine a(h n ) reassortant influenza virus containing the na of a ⁄ california ⁄ ⁄ (h n ) and the ha of a ⁄ equine ⁄ prague ⁄ ⁄ (h n ) generated by classical genetic reassortment in embryonated chicken eggs (ce). parental a ⁄ equine ⁄ prague ⁄ ⁄ (h n ) influenza virus was obtained from the center for disease control and prevention, atlanta, ga, usa. viruses were propagated in day old ce and purified by sedimentation out of the allantoic fluid, followed by ultracentrifugation on - % sucrose step gradient. for the mouse studies, week old cba mice were inoculated intranasally with one dose eid ⁄ ae ml of a ⁄ ⁄ california ⁄ ⁄ (h n ) vaccine strain or received ae ml pbs. blood samples were collected on day post inoculation. healthy young adults were immunized twice, or days apart in the fall with a ⁄ ⁄ california ⁄ ⁄ (h n ) laiv manufactured by microgen, irkutsk, russia. for the human studies, peripheral blood specimens were collected from volunteers before vaccination, days after the first vaccination, and days after the second dose of vaccine. sera from five subjects diagnosed with influenza a(h n ) were collected in december , to weeks post infection and kindly provided by e. vo ıtsekhovskaia from biotechnology laboratory, institute of influenza, rams. also, sera obtained in from unvaccinated vol-unteers were tested for presence of cross-reactive antibodies to a ⁄ california ⁄ ⁄ (h n ). sera were treated with a receptor-destroying enzyme from vibrio cholera (denka-seiken, tokyo, japan) and then were tested in duplicates for hemagglutination-inhibition (hi) h specific antibodies by standard procedures using a ⁄ ⁄ california ⁄ ⁄ (h n ) test antigen. the peroxidase-linked lectin micro-procedure previously reported by lambre, et al. was adjusted to assay ni antibody. briefly, -well plates (sarstedt, inc., nümbrecht, germany) were coated overnight with ll of lg ⁄ ml fetuin. the purified a(h n ) reassortant virus was diluted in pbs with % bsa and mm ca + to give a four times higher optical density at nm (od ) compared to control wells not containing virus. fifty-microliter volumes of serially diluted serum samples were incubated with an equal volume of prediluted virus for hour at °c. after incubation, the plates were washed and neuraminidase activity was measured by subsequently adding peroxidase-labeled lectin ( lg ⁄ ml; sigma, st. louis, mo, usa), incubating for hour at room temperature, washing the plates, and adding ll of peroxidase substrate (tmb). the reaction was stopped after minute by adding ll of n sulfuric acid. od values were measured at nm using the universal microplate reader (el x ; bio-tek instruments, inc., winooski, vt, usa). the ni titers were expressed as the reciprocal dilution that gave % od of positive control (virus, no serum control). in addition we used an igg elisa assay with ae lg ⁄ ml of purified na from a ⁄ california ⁄ ⁄ (h n ) to test sera from immunized mice and volunteers. data were analyzed with statistica software (version ae ) (statsoft, inc. tulsa, oklahoma, usa). geometric mean titers (gmt) were calculated and used to represent the antibody response. the comparisons were made within groups between pre-and postvaccinated titers (expressed as log ) after first and second vaccination using wilcoxon matched pairs test. to compare multiple independent groups we used a kruskal-wallis anova with subsequent multiple pairwise comparison based on kruskal-wallis' sums of ranks. a p-value of < ae was considered to be statistically significant. in mice, one dose of laiv induced antibody responses to both ha and na components of the a ⁄ california ⁄ ⁄ (h n ) influenza virus vaccine (table ) . geometric mean titers of ni antibody levels from vaccinated mice were ae and were significantly higher compared to those in unvaccinated control animals (p < ae ). elisa igg titers expressed as log were ae compared to ae in control group. there was good correlation between antibody rises obtained using ni or elisa tests (r = ae ). in a study during the fall of , % of examined unvaccinated subjects were negative to pandemic a(h n ) (hi titers £ : ). serum hi antibody titers to pandemic a(h n ) ‡ : were considered to be protective against *the postvaccination gmts of hi antibodies after revaccination were higher than respective prevaccination titers (p = ae ) **the postvaccination gmts of ni antibodies after revaccination were higher than respective prevaccination titers (p = ae ) serum hi and ni antibodies to a ⁄ california ⁄ ⁄ (h n ) after one or two doses of pandemic laiv were evaluated in subjects who had pre-vaccination hi titers £ : ( table ) . post-vaccination gmts of a(h n )-specific antibodies were significantly higher than pre-vaccination titers only among subjects who received two doses of laiv ( table ). the frequency of subjects with ‡ fourfold rises in hi antibody titers was higher after two doses ( ae %) compared to responses after one dose ( ae %) although the differences were not statistically significant ( table ). the highest antibody titers of hi and ni antibodies were achieved after natural infection (p < ae compared to all post-vaccination groups). all five subjects with confirmed influenza also had high levels of n -specific igg measured by elisa using purified na as the coating antigen (data not shown). influenza ha and na surface proteins are primary targets of neutralizing antibodies that provide protection against influenza infection. the correlation of strain-specific hi antibody titers ‡ : to protection of % of the subjects against influenza infection is based on a number of reports published in s. serum antibodies against viral na as result of influenza infection or vaccination also can neutralize the virus from infecting cells; however, little is known about protective levels of such antibodies. to evaluate ni antibodies directed against pandemic a(h n ) we used the reassortant a(h n ) influenza virus with mismatched ha to avoid non-specific inhibition. we demonstrated laiv immunization effectively increased levels of ni antibody, although in smaller amounts compared to influenza infection. our data suggest that an antibody to neuraminidase, resulting from an earlier infection of the circulating seasonal influenza a(h n ), evidently cross-reacted with the n of pandemic influenza virus, perhaps due to the previously reported % of conserved na epitopes in pandemic a(h n ). the peroxidase-linked lectin test using the reassortant a(h n ) influenza virus was shown to be a sensitive and time effective means of revealing homologous and cross-reactive anti-na antibodies after laiv immunization or influenza infection. this could be a useful method for influenza vaccine evaluation. significant levels of anti-na antibodies detected in peripheral serum from subjects infected with wildtype h n virus or with h n laiv. and the cross-antibody response to ph n . for calculation of geometric mean titer (gmt), a titer of < was assigned a value of . statistical significance was determined by paired t-test. cross-reactive antibody response to ph n in vaccinated populations of seasonal influenza virus table shows the antibody response to seasonal influenza viruses and ph n of participants. before vaccination, no or little antibody response to ph n had been detected in all age groups. vaccination with seasonal influenza vaccines resulted in seroresponse in over % of subjects, except children aged - years ( %) and subjects aged of - years ( %) vaccinated with - season influenza vaccine and adults aged ‡ years ( %) vaccinated with - season influenza vaccine. seroconversion was detected in over % of subjects of all ages. postvaccination to prevaccination gmt ratios for response to seasonal influenza viruses was more than ae -fold. in contrast, seroresponse to a ⁄ california ⁄ ⁄ after vaccination with - and - seasonal influenza vaccines were detected in only % and % of those aged - years, % of those aged - years, % and % of those aged - years, % and % of those aged ‡ years, respectively. seroconversion in all participants ranged from % to %, and postvaccination to prevaccination gmt ratios were < ae -fold. preexisting antibody response to ph n among subjects born before s in china according to a recent report, people who were born from to had a preexisting immunity to ph n . although only a very low level of cross-reactive antibody response to ph n had been observed among older subjects aged more than years old in china, we further analyzed these data by different age distribution of subjects, which can trace back to the previous infection that is genetically and antigenically more closely related to this new ph n influenza virus. the proportion of seroresponse to ph n with the titer of , , and (highest titer detected from participants of all ages in this study) and the value of gmt were analyzed according to the birth decade of subjects from . similarly, a peak of antibody response and the value of gmt occurred both in subjects born from to and sharply decreased afterward ( figure ). the seroresponse of subjects born in and before is significantly higher than subjects born afterward (p < ae ). similar to recent studies in some asia countries (guangxi province of china and singapore), limited antibody response to ph n had been detected in children and adults. , but, some other studies from european countries (finland, germany, the united kingdom) and the united states reported a high proportion of older individuals aged > years with pre-existing cross-reactive antibodies to ph n , which may possibly ba a result of previous exposure to antigenically related h n influenza viruses circulating in earlier decades or a lifetime of exposure to influenza a, which has resulted in broad heterosubtypic immunity among older individuals in those countries. previous infection and vaccination with a ⁄ new jersey ⁄ may also contribute to the high level of cross-reactive antibody response to ph n among adults older than years in the us. , the peak of the antibody response to ph n in subjects born between and , which is consistent with recent reports, may suggest the previous viral infections of spanish flu or closely related influenza viruses, which is before and little after the year of . recent antigenic report of new ph n viruses indicated that they are antigenically homogeneous among historical viruses, which are most similar to classical swine a(h n ) viruses. a number of reviews [ ] [ ] [ ] [ ] confirmed that the virus is the likely ancestor of all four of the human and swine h n and h n lineages, as well as the 'extinct' h n lineage. in , a(h n ) influenza viruses were first isolated from swine. they have been shown to be antigenically highly similar to the recently reconstructed human a(h n ) virus. the cellular responses may contribute to the sustaining and long term antibody response. probably, boosting by persisting antigenically related viruses in the early decades of the th century, may have contributed to the ability of these subjects to sustain memory b cells, and it is well established that a subset of plasma cells is long-lived, and these cells contribute to durable humoral immune responses, such as that observed after childhood smallpox vaccination. furthermore, t cells that recognize cross-reactive epitopes are preserved and might be enriched in the memory population; the course of each infection is influenced by the t-cell memory pool that has been laid down by a host's history of previous successive infections. our study indicated that wide transmission of this new virus or any antigenically close related influenza a(h n ) viruses may not have circulated among populations in china before the outbreak of ph n . our data also suggests the need for vaccination with ph n vaccine in all age groups. hypo-and agammaglobulinemia patients have an impaired immune system and are particularly susceptible to bacterial infections that are normally defended against by antibodies. therefore, patients routinely receive replacement therapy with immunoglobulins isolated from healthy blood donors. these patients are also prone to get viral infections, possibly due to defects in toll-like receptors and . because these patients lack an antigen specific humoral immune response, they are rarely vaccinated. the ability of hypogammaglobulinemic patients to produce a specific cell-mediated immune response upon vaccination has only been sparsely investigated. in contrast to local mucosal antibodies, vaccine-induced cell-mediated immunity is not believed to protect against pathogen entry per se, but may be sufficient to provide protection against severe disease and death following transmission of some microbes. , the aim of this pilot study was to investigate if influenza vaccination of hypogammaglobulinemic patients can induce an influenza-specific cell-mediated immune response. we therefore vaccinated hypogammaglobulinemic patients and healthy controls with pandemic h n virus vaccine and subsequently investigated the bcell and t-cell responses. the percentages of ifn-c, il- , and tnf-a cytokine producing cd + th -cells were determined, as these cytokines are important indicators of cell-mediated immunity. five a-or hypogammaglobulinemic patients were classified based on the freiburg classification : patient # is diagnosed with x-linked agammaglobulinemia, patient # and # are in group ia, patient # is in group ib and patient # is in group ii. the monovalent egg grown split virus vaccine adjuvanted with as was manufactured by glaxosmithkline (gsk), belgium. the vaccine strain was produced by reassortment between influenza a ⁄ california ⁄ ⁄ (h n ) and a ⁄ pr ⁄ ⁄ (h n ) to produce a ⁄ california ⁄ ⁄ -like virus (x a). the vaccine was mixed with adjuvant to contain ae lg haemagglutinin (ha) of a ⁄ california ⁄ ⁄ -like virus (h n ), squalene ( ae mg), dl-atocopherol ( ae mg), and polysorbate ( ae mg) per ml. healthy controls and hypogammaglobulinemia patients were vaccinated by intramuscular (im) injection. hypogammaglobulinemia patients received one or two vaccine doses days apart. the intention was to vaccinate the hypogammaglobulinemic patients with two doses of ae lg ha, but ae lg ha was inadvertently administered to the patients as the first dose. for patient # this was the second dose as he had received an initial dose of ae lg ha months prior to the study. patient # , # , and # received a second dose of ae lg ha. four healthy controls were immunised with one dose of ae lg ha according to norwegian national guidelines. peripheral blood mononuclear cells (pbmcs) were harvested and washed in pbs with % fbs. the pbmcs were resuspended in lymphocyte medium (rpmi with l-glutamine, ae mm non-essential amino acids, mm hepes ph ae , mm sodium pyruvate, iu ⁄ ml penicillin, lg ⁄ ml streptomycin, ae lg ⁄ ml fungizone and % fbs) prior to use in the enzyme-linked immunospot (elispot) and influenza-specific cd + t-cell assays. serum haemagglutination inhibition antibodies were tested by a standard method using ha units and ae % turkey erythrocytes. all samples were tested in duplicate and the test was repeated at least two times. titres < were assigned a value of for calculation purposes. for numeration of antibody-secreting cells (asc), an eli-spot assay was conducted as previously described with the following modifications. ninety-six well elispot plates were coated with lg ⁄ ml of a ⁄ california ⁄ ⁄ like (x a) h n virus diluted in pbs overnight at °c. after blocking with rpmi ( % fbs), pbmcs were added and incubated ( °c, % co ) for hour. secreted antibodies were detected with biotinylated goat anti-human igg, iga and igm specific antibody (southern biotech, birmingham, alabama, usa), incubated for hour at room temperature and developed with extravidin peroxidase and aec substrate. the numbers of spots were counted using an elispot reader (immunoscanÔ) and immunospot Ò software. the influenza-specific cd + th -cell response was measured by intracellular cytokine production of ifn-c, il- , and tnf-a. peripheral blood mononuclear cells ( per well) were incubated for hour ( °c, % co ) in ll lymphocyte medium containing lg ⁄ ml anti-cd , lg ⁄ ml anti-cd d, ae lg ⁄ ml monensin, lg ⁄ ml brefeldin a, (bd biosciences, franklin lakes, new jersey, usa), and the h n influenza split virus vaccine x a (either ae lg ⁄ ml or lg ⁄ ml ha). basal cytokine production was determined by incubating pbmcs in lymphocyte medium without influenza virus, and the percentage of cytokine positive cells without influenza stimulation were subtracted from influenza-stimulated cells. cells were stained for cd , cd , cd , ifn-c, il- , and tnf-a (bd biosciences) as previously described. finally, cells were resuspended in pbs containing % fbs and ae % sodium azide and analysed by bd facscanto flow cytometer ( - cells acquired). flowjo v ae ae (tree star, ashland, oregon, usa) was used for data analysis. five to six fold lower gmts were found in the patient group as compared to the healthy controls throughout the study ( figure a) . the lowest hi titres were obtained in patients # , # , and # , whilst patients # and # and all healthy controls fulfilled two of three european medicines agency committee for medicinal products for human use (chmp) seasonal influenza vaccine licensing criteria, by obtaining an hi titre > and a mean geometric increase of ae between pre-and post-vaccination. thus, the hi data indicate that two vaccine doses was sufficient to induce a protective hi antibody response in two out of five of the hypogammaglobulinemia patients tested in this study. the numbers of influenza-specific iga, igg, and igm asc were tested pre-vaccination and days post-vaccination with the h x a virus. few or no ascs were detected pre-vaccination (data not shown). at days post-vaccination the patient's iga, igg, and igm asc levels were significantly lower (p < ae ) compared to the healthy controls ( figure b) . but, the post-vaccination asc numbers in the patients were generally higher than at pre-vaccination stage ( - ascs). patient # had the highest iga and igg asc numbers, followed by patients # and # , whilst patient # and # had few or no asc's. these results confirm that the patients are indeed hypogammaglobulinemic and that some of the patients (# and # ) could be agammaglobulinemic in the context of producing influenza-specific antibodies. the asc levels of patients # , # , and # were lower than those of the healthy controls, but could possibly be adequate for reducing the severity of influenza disease. the influenza-specific th -cell response was evaluated by stimulating pbmcs with the influenza x a virus , , and days post-vaccination. stimulation of healthy control pbmcs with x a days after vaccination, induced ifn-c, il- , and tnf-a production by an average of ae %, ae %, and ae % cd + t-cells, respectively. patient # and # had higher responses than the healthy controls and stimulation with x a induced ae %, ae %, and ae % of t-cells from patient # to produce ifn-c, il- , and tnf-a, respectively (figure a) . the response of patient # was further boosted by a second vaccine dose, which resulted in ae %, ae %, and ae % cd t-cells producing ifn-c, il- , and tnf-a, respectively at day ( figure b ). these results show that the hypogammaglobulinemia patients studied here did not have a common impaired influenza-specific cd + th cytokine response. rather, there was a tendency towards increased responses, suggesting that the diminished antigen specific b-cell responses could induce a compensatory antigen specific th -cell response. the results from this pilot study suggest that some hypogammaglobulinemia patients may benefit from influenza vaccination. we found very different patient responses to influenza vaccination, but some of the patients (patient # and # ) did mount low influenza-specific asc responses. in addition, the vaccine-induced hi antibody titres above the protective level in patient # and # . these results are in accordance with previous publications, which described that polypeptide vaccines induce humoral responses in subgroups of common variable immunodeficiency patients. [ ] [ ] [ ] in this study, we also investigated cell-mediated immunity and found the percentages of homologous and cross-reactive influenza-specific cd + th -cells to be in the same range (for patient # , # , and # ) or higher (for patient # and # ) in the a-or hypogammaglobulinemic patients compared to the healthy controls. the higher response is probably due to the patients having received a vaccine dose of ae lg ha, whilst the controls received ae lg ha. in addition, the patients received a second booster dose, which influences the day and months responses. nonetheless, these results are the first to demonstrate that proliferation of pandemic influenza antigen specific th cells can be induced in hypogammaglobulinemic patients. in addition, vaccination induced influenza-specific asc's in some patients. the findings are promising and provide hope that hypogammaglobulineamic patients could be vaccinated against influenza and other diseases preventable by figure . peripheral blood mononuclear cells s from patients and healthy controls were isolated at day (a), (b), and day (c) and stimulated for hour with x a virus before staining and flow cytometric analysis. the figure shows the mean ± sd frequency of influenza-specific cd + cytokine producing cells (%) where the basal cytokine production from unstimulated cells has been subtracted. data for the hypogammaglobulinemia patients are additionally shown as a number for each patient. **significantly higher frequency of il- producing cd + t-cells in the patients compared to the healthy controls (students t-test p < ae ). titres are presented as the geometric mean titre ± % confidence interval. elispot data (b) are presented as the mean number of influenza-specific iga, igg, and igm ascs per peripheral blood mononuclear cells ± sem. data for the hypogammaglobulinemia patients are additionally presented by a number for each patient. *significantly higher numbers of ascs were detected in the healthy controls as compared with the hypogammaglobulinemia group (students t-test, p < ae ). vaccination. however, this hypothesis should be tested in larger clinical studies. the influenza virus undergoes antigenic evolution under intense immune selection pressure from herd immunity in humans through the process called antigenic drift and shift. , because of antigenic drift, yearly updating of vaccine strain is needed. a mismatch between the circulating strains and the vaccine strain in the subsequent season is often encountered, resulting in reduction of vaccine effectiveness and lack of protection from the circulating strain. in order to address this, a universal influenza vaccine based on a more conserved part of the influenza virus, which is not affected by antigenic change and that is conserved across all strains, remains the ultimate goal to afford cross-protection to drifted strains as well as to other subtypes of influenza which may arise from antigenic shift. , previous studies have investigated the potential of the m e. , m e has remained highly conserved since it was first isolated in . several studies have examined the use of m e as a vaccine component, using various approaches including proteins, peptides, dna vectors, and attenuated viral vectors. , [ ] [ ] [ ] [ ] [ ] [ ] although m e is a weak antigen, by linking the protein to a carrier hepatitis b virus core particle, protection against influenza has been achieved in mice particularly when administered with an adjuvant. some articles found that vaccination with m e coupled to hbc induces protective antibodies, whereas the contribution of t cells to protection was negligible. protection induced by vaccination with m e-hbc was weak overall and failed to prevent weight loss in vaccinated infected animals, and mice succumbed to high dose infection. we aimed to address the poor immunogenicity of m e-hbc by using igv as adjuvant. igv domain is common and conserved in the tim family. ligand binding sites of t cell immunoglobulin mucin (tim) located at igv domain. [ ] [ ] [ ] tim function is done by anti tim antibody which recognized the ligand binding sites of igv domain. tim family members share a common motif, including an igv domain. they are differentially expressed on th cells and th cells with the ability to regulate the immune system. , the igv domain of human b - is sufficient to co-stimulate t lymphocytes and induce cytokine secretion. soo hoo et al. vaccinated with tim- antibody and inactivated influenza and found enhanced vaccine-specific immune response. we report here for the first time the use of igv recombinant protein as adjuvant to immunize mice with influenza m e-hbc. results indicated that igv can induce the strong cellular immune response and cross reaction with different subtype influenza virus antigen. target igv may be used to develop the new method for vaccination strategies. expression and purification of recombinant igv protein rna was extracted from healthy human pbmc. one-step rt-pcr (qiagen, valencia, ca, usa) was done for the amplification igv gene. the pcr product was purified and cloned into pet a (novagen, madison, germany). the resultant construct pet a-igv has a histidine (his) tag ( his) at the n terminus. dna sequence of the insert was determined by sequencing. igv. recombinant protein was expressed in escherichia coli and was purified on a ni column (novagen). the purified protein was examined by sds-page and western blotting. six-eight weeks female balb ⁄ c mice (institute of zoology chinese academy of sciences, china) was used for the study. mice were immunized twice intradermally with ug m e-hbc (provided by cnic, china) combined with different doses of recombinant igv protein , , ug, respectively, or without igv as control. the area proximal to the tibialis anterior muscle was sterilized with % ethanol and different groups of mice were injected bilaterally with , , ug igv plus ug m e-hbc in ul phosphate buffer saline per mouse using a ml syringe with attached ⁄ ¢¢ g needle. the immunization was given at weeks intervals. four blood samples were obtained from every mouse: before immunization, after the first and second immunization, and after virus challenge by retro-orbital plexus puncture. after clotting and centrifugation, serum samples were collected and stored at ) °c prior to use for assays. mouse-adapted a ⁄ pr ⁄ ⁄ (h n ), a ⁄ brisbane ⁄ ⁄ (h n ), a ⁄ xinjiang ⁄ ⁄ (h n ), and a ⁄ guangzhou ⁄ ⁄ (h n ) were provided by chinese national influenza centre. nine to eleven days old embroynated specific pathogen free (spf) chicken eggs were inoculated with virus, and the eggs were incubated at °c for - days. the allantoic fluid was collected and purified by sucrose density gradient centrifugation, and the virus was inactivated by formaldehyde at °c overnight. to identify igg, igg , igg a against m e, elisa assays were used. in brief, -well (nunc, brunei, denmark) were coated with ul ⁄ well of m e recombinant protein (provided by gene lab of ivdc, xuanwu district, beijing, china) in carbonate buffer (ph ae ) overnight at °c. immediately before use, the coated plates were incubated with blocking solution ( % bsa in pbs) for h at °c and washed four times with pbs containing ae % tween (pbs-t). the serum samples were serially diluted and added in the plates. the detection color was developed by adding hrp-labeled goat anti-mouse igg, igg , or igg a ( figure ) . no cross-strain response was observed in the control group. the igv adjuvented groups show splenocytes stimulation with seasonal h n , h n , h n , and h n antigens. m e-hbc immunization without igv showed splenocyte stimulation, but the extent was lower than animals immunized in the presence of the igv adjuvent. these data suggested that igv had enhanced effect on priming against the conserved viral antigen matrix protein and generation cross-strain immune response. influenza is a respiratory disease causing epidemics every year. h n viruses and swine-origin h n have also infected humans in recent years. seasonal influenza vaccine cannot cope with significant antigenic drift or with the emergence of pandemic viruses of different subtypes not contained in the vaccine. the high extent of conservation of the m e makes it a promising immunogen. a vaccine based on coupling of the m e peptide to an appropriate carrier may provide a universal vaccine with effectiveness and safety. m e based vaccination induces protective antibodies not only in mice, but also in ferrets and monkeys. the carrier hepatitis b core as carrier with m e forms a virus like particle (vlp). vaccination with m e coupled to hbc induces protective antibody, whereas the contribution of t cell protection was negligible. protection induced by vaccination with m coupled to hbc was weak overall. in order to improve the vaccination effect of m e-hbc, new adjuvant igv was evaluated in combination with the m e-hbc. the tim molecules are a recently discovered class of proteins with the ability to regulate the immune system. crystal structures of the tim molecules has revealed a unique, conserved structure with ligand-binding sites in the igv domain. to determine the potential immunostimulatory molecular properties of igv, we have evaluated immune response of the igv in combination with m e-hbc vlp. previous papers reported that vlp immunized mice can induce the th and th immune response. different adjuvant combined vlp can produce biased immune response th ⁄ th mixed immune response, or th -preferred th ⁄ th profile. thus, the response following the use of igv as a new adjuvant combined with m e-hbc vlp needs to be evaluated. results indicated that igv combined groups showed th biased immune response and enhanced cross reactive t cell immune responses. this may show that igv immunized the mice and antiigv antibody can cross link the igv on t cells and enhance the cell figure . t cell proliferation assay. mice were immunized twice with , , , ug ⁄ ml igv plus m e-hbc, respectively, and naive group was immunized with pbs. three weeks after a boosting immunization, spleens were harvested from immunized and naive mice. different subtypes of inactivated virus antigen (a) h n , (b) h n , (c) h n , (d) h n were added and cocultured with different group splenocytes for h. quick cell proliferation assay kit was used to detect the cell proliferation. the - nm absorbance was read on a plate reader. data were showed were shown as mean values. the difference between naive group and different doses igv plus m e groups was determined using the student's t-test. all significance level is p < ae . response. we also evaluated the cross-protection produced by igv combined m e-hbc. we challenge with mouseadapted strain pr and prove the cross protection via reaction between the cells from the immunized animal and different subtypes of virus antigen. some subtypes of virus cannot infect the mice naturally, and therefore, virus challenge cannot be used to evaluate the effect. we co-cultured the t cells with inactivated antigen h , h , h , and h , and t cell proliferation was measured. results indicated that after immunization with igv plus m e-hbc, the t cells show cross-protection with other subtypes. this provides evidence that igv can enhance the cross protection across subtypes. the results of this study demonstrated that recombinant igv can be useful as an adjuvant and polarize the m e-hbc vlp immune response to a th profile. igv induced the m e-hbc vlp to induce t cell proliferation and cross-reactive responses to different influenza virus subtypes. this finding represents a new direction for the promotion of cell mediated immunity in m e based vaccine against influenza. a core european protocol, i-move, describing the methods to estimate influenza vaccine effectiveness (ive) was proposed by the european centre for disease prevention and control (ecdc) and epiconcept for the - season. it includes a case control method for pooled analysis based on a randomized ''systematic'' sample of swabs. , collection of swabs using a non randomized, i.e., ''ad hoc,'' sampling strategy, left at the appreciation of sentinel practitioners, provides a greater number of cases and con-trols for ive estimation more easily than using a systematic randomized sampling strategy. the french grog (groupes régionaux d'observation de la grippe) early warning network collects more than specimens yearly from cases of acute respiratory illness (ari), using both sampling methods. , during the circulation of pandemic influenza viruses in france, it gave an opportunity to compare ive estimates using systematic randomized versus non systematic ''ad hoc'' sampling. influenza vaccine effectiveness was estimated by a casecontrol methodology according to ecdc i-move protocol, using on the one hand a systematic random sampling, on the other hand ''ad hoc'' non random sampling. the study was proposed to primary care practitioners of the grog network ( general practitioners and pediatricians) trained to collect data and swabs. the study population was patients from the community of all ages consulting a grog practitioner for an influenza like illness (ili) and having a nasal or throat swab taken within an interval of < days after symptom onset. ili was defined according to the european union (eu) case definition as sudden onset of symptoms with at least one of the following four systemic symptoms: fever or feverishness, malaise, headache, myalgia; and at least one of the following three respiratory symptoms: cough, sore throat, shortness of breath. swabs were performed through usual surveillance. no ethical approval was needed, but an oral informed consent was requested. cases were excluded if they refused to participate in the study or if they were unable to give informed consent or to follow the interview in native language because of aphasia, reduced consciousness, or other reasons. an individual was considered as vaccinated against pandemic influenza if he or she reported having received a pandemic influenza vaccination during the current season, and if at least one vaccine dose occurred more than days before ili onset. the study period started with the initiation of active influenza surveillance by the grog network, i.e., days after the beginning of the influenza vaccination campaign, and finished at the end of the influenza period defined as the last week with at least one swab positive for influenza within the grog network. ''ad hoc'' sampling patients from which swabs were taken were selected by the grog practitioners during the study period. systematic random sampling during the same period, patients were selected at random as follows. an age-group - years (gps and pediatricians); - years (gps and pediatricians); - years (gps); years or more (gps) was assigned to each practitioner, who was requested to swab the first patient of the week presenting with an ili within the pre-assigned age-group. swabs were collected in appropriate transport medium (virocult Ò , viralpack Ò , utm copan Ò ) and sent by post to the laboratory in triple packaging following the international guidelines for the transport of infectious substances (category b, classification un ). laboratory confirmation of influenza was by rt-pcr to detect currently circulating influenza a (subtypes h , seasonal and pandemic h ) and b viruses. an influenza case was defined as an ili case with a respiratory sample positive for influenza during the study period. controls were cases of ili having a swab negative for influenza during the study period. the outcome of interest is laboratory confirmed influenza. confounding factors and effects modifiers identified during the i-move preliminary study were registered: risk factors, chronic diseases, severity of underlying conditions, smoking history, former vaccinations, and functional status. data on cases and controls were collected by the practitioners using a standardized questionnaire adapted from the i-move study. questionnaires were sent by the practitioners with the swab to the virology laboratory, and sent to the grog national coordination. data entry and validation were ensured by open rome through the vircases computing tool. validation steps included control of exhaustiveness of centralization of questionnaires, comparison of data entered by the labs and the national grog coordination, coherence control, and identification of missing data. analysis was done for the two sampling groups (systematic and ad hoc) on cases ⁄ controls following the european method proposed by epiconcept, using excel ª (microsoft corp. redmond, washington, usa) and stata ª . baseline characteristics of cases and controls in unmatched studies were compared using the chi-square test, fisher's exact test, or the mann-whitney test (depending on the nature of the variable and the sample size). the association between vaccination status and baseline characteristics was assessed for both case and control groups. the vaccine effectiveness was computed as ive = )or (odds ratio). an exact % confidence interval (ci) was computed around the point estimate. analysis was stratified according to age groups, time (month of onset), presence or absence of chronic disease, and previous influenza vaccination. effect modification was assessed comparing the or across the strata of the baseline characteristics. confounding factors were assessed by comparing crude and adjusted or for each baseline characteristic. a multivariable logistic regression analysis was conducted to control for negative and positive confounding factors using a complete case analysis (with records with missing data dropped) and using multiple imputation with chained equations. the complete model included age group, number of gp visits, onset week, seasonal vaccination, previous seasonal influenza vaccination, presence of chronic disease and associated hospitalizations in the previous months, gender, and smoking status. variables were tested for multi-colinearity. interactions were tested using the likelihood ratio test (or wald test) and included in the model if significant at % level. a model with fewer variables (age group, number of gp visit, onset week, and seasonal vaccination) was also tested. several models were applied to both the ''ad hoc'' and systematic sampling groups of cases and controls. as shown in table , whatever the analysis method used, the ''ad hoc'' sampling strategy led to a slightly lower estimate of ive. the ci were extended when data were missing and reduced when using multiple imputations with chained equations. however, from a statistical point of view, comparison of ''ad hoc'' versus systematic strategies is not straightforward, because ''ad hoc'' sampling is not randomized and does not allow comparisons with statistical tests using statistical distribution laws. there are more missing data with the ad hoc sampling method. this is mainly due to our validation procedure: in the case of missing data in the systematic sampling group, as required by the i-move study protocol, queries were sent to sentinel practitioners using mail and phone calls. this specific heavy workload is not usually performed during routine surveillance and has not been achieved for the ''ad hoc'' sampling group given the great number of cases and controls ( ). within the framework of the i-move study, several items were added to the grog's usual clinical form accompanying swabs (hospitalizations, number of gp visits, smoking status, help needed for bathing or walking). in - , gps explained that this added workload was not compatible with their daily additional workload due to the pandemic situation. therefore, many of them refused to fill these new items systematically and threatened to leave the network. we thus obtained that the ''i-move items'' would be filled in for the clinical forms linked to systematic sampling, but were not in a position to obtain that for ''ad hoc'' sampling. the weekly distribution of systematic swabbing is not similar to that of ad hoc swabbing. the percentage of ad hoc swabs was higher than systematic swabs during the pandemic wave (mid-november to end of december) during which time the percentage of swabs positive for influenza was also higher ( figure ). this could explain the higher rate of positive swabs within the ''ad hoc'' samples. the vaccination campaign was launched by the ministry of health on october , , and vaccination coverage increased during the surveillance period. in february, the vaccination coverage was ae % in patients swabbed in the systematic group ( ae % on imputed data) and ae % [ ae - ae ] in the ad hoc group ( ae % on imputed data). at the national level, vaccine coverage is estimated at ae %. due to the over-mediatisation of pandemic vaccination and to rumors about its poor effectiveness, overconsultation of vaccinated patients and over-swabbing of vaccinated patients in the ad hoc group are not surprising. age distribution is significantly different between our two samples (p < ae ): the rate of - years old is lower in the systematic sampling group ( ae %) than in the ad hoc sampling group ( ae %). this can be explained by the fact that for the systematic sampling procedure, each grog practitioner had to swab the first ili patient in his assigned age group, whereas for ''ad hoc'' sampling, every grog practitioner could swab any ili patient irrespective of age. given the emphasis by health authorities and media on the burden of pandemic influenza among children and teenagers, one can hypothesize that when they were able to, sentinel practitioners focused on these age groups. gps in the ad hoc sampling scheme seem to have been more likely to select cases and further, to select vaccinated cases. those patients may have consulted earlier with specific symptoms (strong headache being more prevalent among cases). over-swabbing of patients having these symptoms in the ad hoc group is likely. the - pandemic influenza season was markedly different from previous ones: vaccination rate increased during and mainly after the pandemic peak; behaviors were strongly modified by unusual media hype; clinical features and risk factors might be different. it will be necessary to see if similar results are observed during a regular influenza season during which the vaccination rate increases before the epidemic peak with usual messages about vaccination and usual clinical influenza features. influenza early warning networks can estimate ive, taking into account many covariates. from a stakeholders and patients point of view, during the - influenza pandemic wave, there were no major discrepancies between ive estimated with an ad hoc sampling strategy, based on sentinel practitioners instinct, and ive estimated with a systematic random sampling strategy whatever the multivariable analysis methodology. although from a statistical point of view, comparison of the two strategies is not readily feasible because of the non random nature of ad hoc sampling. this latter strategy seems to result in slightly lower ive estimates, which could potentially be attributed to sentinel practitioners swabbing behavior. the ability to avoid missing data is a key point to decide which sampling method must be adopted, because ci extent depends greatly on the proportion of missing data among covariates. to match ive evaluation to surveillance networks practicality, selection of only those data essential for the study endpoint and easily collected by sentinel practitioners is paramount. it will be necessary to determine if results similar to those observed during the - pandemic season are found during a regular influenza season. influenza a viruses are important pathogens which remain a major cause of morbidity and mortality worldwide, and large numbers of the human population are affected every year. the first influenza pandemic in this century broke out in humans in march , and it was declared to be pandemic by mid-june. as of august jul , the pandemic virus had caused more than deaths worldwide, according to the world health organization (http:// www.who.int/csr/don/ _ _ /en/index.html). the infection and spread of the pandemic influenza was reduced in part due to the use of vaccines. however, the lack of h n pdm vaccine early in the pandemic illustrates the need to improve vaccine production and to generate vaccines that induce stronger cross-protection. inactivated split vaccines or live attenuated influenza virus vaccines (laivs) against h n pdm viruses were approved for human use by the united states food and drug administration. both the inactivated vaccines and laivs are produced by creating reassortant viruses that generally contain six vrnas (pb , pb , pa, np, m, and ns) from a master donor strain, plus the two glycoprotein vrnas (ha and na) from a virus that antigenically matches the strain predicted to circulate in upcoming influenza season (e.g. a ⁄ ca ⁄ ⁄ ). the reference viruses containing inactivated split virus vaccines are produced in embryonated chicken eggs, and primarily result in the production of antibodies that recognize the viral glycoproteins. both of these vaccine approaches require significant lead time for vaccine production, and modern approaches to speed preparation of vaccines and improve their efficacy is a global priority. , the ns protein of influenza a virus is a multifunctional protein that plays important roles in virus replication and as potent type i ifn antagonist. , mutations and ⁄ or deletions in ns typically induce stronger ifn responses by the host; those in turn suppress the replication of influenza virus - and can enhance immune recognition. [ ] [ ] [ ] [ ] in this study, we created a panel of experimental h n pdm ns-laiv candidates that have different deletions in the ns vrna and analyzed the vaccine potential of each ns-laiv in mice and ferrets to identify the best candidate(s). wt h n pdm influenza a virus a ⁄ new york ⁄ ⁄ (ny ) was created by reverse-genetics directly from a human swab specimen collected in new york state in april . deletions were introduced into the ny ns plasmid to create three mutant ns segments: ns - , ns - , and nsd . nucleotides - (cdna of ns segment) and - were replaced by stop codons to generate ns - and ns - ; nucleotides - were deleted to generate nsd , whose open reading frames for ns and nep were maintained. recombinant viruses were generated by co-transfection of eight reverse-genetics plasmids carrying the cdna of each gene segment into t ⁄ mdck cocultured monolayer adapted from hoffmann et al. , mouse studies experiments were performed in a biosafety level laboratories approved by the u.s. centers for disease control and prevention and the u.s. department of agriculture, and were conducted under approved animal care and use protocols. groups of -week-old female balb ⁄ cj (jackson laboratory, bar harbor, me, usa) were anesthetized with isoflurane and inoculated intranasally with tcid of each recombinant virus in ll of pbs diluent, or pbs as controls. body weights and clinical symptoms of the mice were monitored daily for days. nine mice in each group were euthanized on , , and days post inoculation (dpi), and nasal washes and lungs were collected for virus titration by tcid assay in mdck cells. at dpi, mice per group were challenged intranasally with · tcid ( ld in -week-old mice) of a mouse-adapted variant of ny (a ⁄ ny ⁄ ⁄ -ma ) (accepted, journal of virology). disease symptoms and weights of the vaccinated mice were monitored for days, and four mice from each virus group were euthanized at and days post challenge. lungs were removed and homogenized for virus titration by tcid assay. the mice that became moribund or lost > % of their starting body weight were euthanized for humane reasons. male fitch ferrets (triple f farms, sayre, pa, usa), - months of age and serologically negative by hemagglutination inhibition (hi) assay for currently circulating influenza viruses were used in this study. groups of or ferrets were inoculated intranasally with ae tcid of one of the viruses: ny wt (n = ), ns - (n = ), ns - (n = ), or nsd (n = ). ferrets were monitored for clinical signs through dpi as previously described. nasal washes were collected on , , , and dpi and were titrated in mdck cells by tcid assay. serum was isolated from blood collected ae weeks after immunization and used for neutralization assays. the ferrets were challenged with pfu of a ⁄ mexico ⁄ ⁄ ae weeks postimmunization and monitored for clinical signs of disease through dpi. nasal washes were collected on , , , and dpi, and were titrated in mdck cells by plaque assay. using reverse genetics, we created three laiv candidates weight loss of wt virus inoculated mice became evident at dpi, and the mice did not recover until dpi (figure a) . in contrast, mice inoculated with any one of the vaccine candidates had no clinical signs of disease and continued to gain weight at the same rate as did the mock- inoculated mice ( figure a ). viral titers in the lungs of ns - , and ns - infected mice were $ -fold lower than titers from wt virus-infected mice at all the time points analyzed ( , , and dpi) ( figure b) . notably, the nsd laiv was cleared from the mouse lungs very rapidly, and the mean titers were $ -fold and -fold lower than the titers of the wt virus at and dpi, respectively ( figure b) . the vaccinated mice were challenged with a mouseadapted variant of ny (accepted, journal of virology) on dpi. no disease symptoms were observed in the mice immunized by any of the ns-laiv candidates or the wt control. in contrast, disease symptoms including ruffled fur, hunched posture, and weight loss were observed in the mock-immunized mice as early as days post challenge (dpc); the symptoms progressed to severe disease, and the animals showed dramatic weight loss, became moribund, and succumbed to infection by dpc (figure c ). high titers of virus ($ tcid ⁄ ml) were present in the mock-immunized mice at dpc and at dpc ( figure d ). in contrast, virus was not detected in the lungs of immunized mice ( figure d ). this challenge data demonstrates that all of the ns-laiv candidates, including the highly attenuated nsd , induced sterilizing immunity that protected mice from a lethal ny h n pdm variant. groups of ferrets were intranasally immunized with ae tcid of each vaccine candidate or the wt virus. the titer of viruses recovered from nasal washes ranged from ae to ae tcid ⁄ ml through day in the wt virusinfected group, while the ns-laivs showed various degrees of attenuation (figure a) . the viral titer of all of the ns-laivs is at least -fold lower than that of wt in the nasal wash collected at dpi. the ns - laiv was the least attenuated in ferrets, and its replication was similar to that observed in mice. relative to the wt virus, the ns - laiv showed -fold reduction in titer, and the nsd laiv was below the limit of detection (at least fold reduction) at dpi. sera from blood collected ae weeks after immunization was analyzed for the presence of neutralizing antibodies by micro-neutralization assays. the ns-laiv candidates all induced very strong neutralizing antibody responses ( - ) that were similar to the titer elicited by wt virus infection ( figure b ). the ferrets were challenged with pfu of a ⁄ mexico ⁄ ⁄ (h n pdm) ae weeks post immunization. little disease or weight loss were observed in the naïve ferrets, and the ferrets immunized by infection with wt virus or the ns-laiv candidates didn't show any disease symptoms or weight loss. in contrast to the high titer of virus detected in the naïve ferrets through dpc, the ns-laiv immunized ferrets had very low levels of a ⁄ mexico ⁄ ⁄ in their nasal washes at dpc ( figure c ). the ferrets immunized with the ny ns-laivs had $ -to -fold lower viral titers than did the naïve animals ( figure d ). in summary, the ns-laiv candidates dramatically inhibited initial replication of the h n pdm virus under stringent challenge conditions ( pfu), and that the vaccinated animals rapidly cleared the infection (to below the limit of detection, by dpc). our results demonstrate that all of the ns-laiv candidates are attenuated compared to the wt h n pdm virus, and the degree of attenuation is dependent on the specific ns mutation. ns - was the least attenuated and does not represent a good vaccine candidate; whereas, nsd and ns - were highly attenuated in both the mouse and ferret models. although they were markedly attenuated, they elicited strong neutralizing antibody responses and protected mice and ferrets from subsequent challenge. nsd has a subtle in-frame deletion ( nt) that affects both the ns (residues - ) and nep (residues - ), and is analogous to a naturally attenuated variant of a normally highly pathogenic h n virus (a ⁄ sw ⁄ fj ⁄ ). the analogous ns deletion in a ⁄ sw ⁄ fj ⁄ (residues - ) was shown to reduce binding to host cleavage and polyadenylation specificity factor (cpsf), reduce ns protein stability, and enhance the type i ifn response of this h n virus. our study indicates that deletion of these nt in the ns vrna of the h n pdm also stimulates the host ifn response, specifically, ifn-ß, ifn-k , ip , and mxa (data not shown). the role of the deletion of residues - from nep has not been elucidated, but the induction of ifn and isgs by nsd was similar to, or slightly lower than, their induction by ns- , suggesting that the nep mutation also has an attenuating effect that warrants future investigation. in summary, we have generated a panel of laivs directly from a swab specimen containing a new pandemic virus and analyzed their attenuation and immunogenicity in two animal models. our study demonstrates that nsd is a novel ns-laiv that could be used to create laivs for diverse influenza a viruses. this study also validates the use of ns-laiv candidates, which are not only highly attenuated, but they also elicit strong innate and adaptive immune responses, resulting in protection of mice from subsequent challenge with a lethal mouse-adapted variant of ny , and ferrets from challenge with a ⁄ mexico ⁄ ⁄ (h n pdm). currently, a total of approximately million doses of inactivated influenza vaccine are being produced worldwide each year. one of the limitations in vaccine production is poor growth of human isolates in embryonated chicken eggs. this is essential to develop high yield seed viruses for large scale production of influenza vaccines. influenza a vaccine production utilizes high yield reassortants carrying ha and na genes from a wild type (wt) strain with generally - internal genes from the a ⁄ pr ⁄ ⁄ (pr ) strain, an highly egg adapted high growth donor strain. influenza b vaccines, however, have been produced directly from wt strains, partly because no high yield donor analogous to pr has been identified. in recent years, reverse genetics has been used as an alternative means of developing high growth vaccine viruses. , since in this plasmid-based technology, a : reassortant (six internal genes from a donor strain and two surface antigen genes from wild type strain) can be directly rescued, reverse genetics-derived reassortant viruses were expected to grow as efficiently as those derived from classical reassortment. however, reverse genetics reassortants have not produced the expected high growth for several reasons: (i) the : configuration is not always the best for virus yield, (ii) there is no process included for positive selection of adaptive mutants from quasispecies, and (iii) cell-derived viruses are not readily adapted to grow efficiently in eggs. our laboratory at new york medical college has been preparing b reassortants for several years by classical reassortment using b ⁄ lee ⁄ as a donor. it has been possible to develop b reassortants, which produce higher virus yields than wt strains in eggs, and it was found that the np gene of b ⁄ lee ⁄ was important in producing high yield b reassortants. however, b ⁄ lee ⁄ is inconsistent in providing high yield properties to b reassortants. in this study, in an attempt to find an alternative donor, we investigated the usefulness of b ⁄ panama ⁄ ⁄ for developing high yield b reassortants. as a wt strain, b ⁄ brisbane ⁄ ⁄ was used, which is one of the recommended influenza b virus vaccine strains for the ⁄ and ⁄ seasons. we found that b ⁄ panama ⁄ ⁄ is a useful donor, and some of the resultant reassortants were considered as vaccine candidates. b reassortant viruses were prepared by the classical reassortment method described by kilbourne. the antiserum to b ⁄ panama ⁄ ⁄ hemagglutinin and neuraminidase (hana) was raised in this study by immunizing rabbits with hana isolated from b ⁄ panama ⁄ ⁄ ; purified igg was used for antibody selection. the yields of the reassortants and their corresponding parent viruses were assessed by hemagglutination assay. viral rna was extracted directly from the allantoic fluid and amplified by rt-pcr to produce cdna for analyzing the gene composition. restriction fragment length polymorphism (rflp) analyses were performed to determine the origin of each gene segment of the high yield reassortants. restriction enzyme sets for each gene segment are available upon request. in this study we investigated the usefulness of b ⁄ panama ⁄ ⁄ as a donor for transferring high yield phenotype. b ⁄ panama ⁄ is a yamagata lineage strain with high growth phenotype (ha titer: - ). b ⁄ panama ⁄ ⁄ itself was a recommended b virus vaccine strain for ⁄ - ⁄ seasons. as a wt virus, a victoria lineage strain, b ⁄ brisbane ⁄ ⁄ , was used, which is a recommended b virus vaccine strain for use in the ⁄ and ⁄ seasons. reassortants were prepared according to classical reassortment protocol. after co-infection of b ⁄ panama ⁄ ⁄ and b ⁄ brisbane ⁄ ⁄ , progeny viruses carrying surface antigens (ha and na) of the vaccine strain were negatively selected by anti-b ⁄ panama hana antibodies, followed by passages without antibodies for positive selection of eggadapted viruses and finally limited dilution cloning. nymc bx- , bx- b, bx- d, and r- a are representative of resultant reassortants, which have significantly higher ha titers than the wt strain. the complete gene compositions of these reassortants were determined by rt-pcr ⁄ rflp analyses. as shown in table , all of these reassortants contained the pb of b ⁄ panama ⁄ ⁄ . other genes of b ⁄ panama ⁄ ⁄ (np of bx- , m of bx- b, and pb of bx- d) may not be involved in the high virus yield, since no significant growth difference among these reassortants in eggs was found as assayed by hemagglutination test. accordingly, the pb of b ⁄ panama ⁄ ⁄ is considered to be the sole factor involved in the high yield phenotype donated to the vaccine strain. we previously found that the b ⁄ lee ⁄ np gene was important in producing high yield b reassortants. it was of interest to examine whether b ⁄ lee ⁄ np and b ⁄ panama pb could work together to produce even higher yields. to test this possibility, bx- b ( : reassortant: pb and m genes from b ⁄ panama and the rest of the genes from b ⁄ brisbane) was selected and further reassorted with b ⁄ lee ⁄ . despite some difficulty in removing the na gene of b ⁄ lee ⁄ (r- c, b, b in table ), by monitoring ha and na genes of resultant viruses after each antibody selection passage with anti b ⁄ lee ⁄ hana antibodies, we were able to isolate and clone a triple reassortant, nymc bx- , which contains the np gene from b ⁄ lee ⁄ and pb and m genes from b ⁄ panama; the remaining genes are from b ⁄ brisbane ⁄ ⁄ (table ). in comparison with bx- b, no significant growth enhancement (nor reduction) in eggs was found for bx- over that seen for bx- b. nevertheless, bx- stably produces high virus yield and has been utilized as a seed virus for influenza b vaccine production for the - season by one or more vaccine manufacturers. there are contradictory reports - about the usefulness of reassortment for high yield influenza b viruses. however, we have been preparing b reassortants for several years by classical reassortment using b ⁄ lee ⁄ as a donor, and have been able to generate higher virus yield than wt strains. in this study, we found that b ⁄ panama ⁄ ⁄ serves as an efficient donor in providing the high growth capacity to b ⁄ brisbane ⁄ ⁄ (a recommended vaccine virus of victoria lineage for ⁄ - ⁄ seasons), and that the pb of b ⁄ panama ⁄ ⁄ is associated with the high yield phenotype. this particular strain from yamagata lineage might be useful to prepare high yield reassortants for other victoria lineage vaccine viruses. we noticed in this study that there may be segment incompatibilities between b ⁄ panama ⁄ ⁄ and b ⁄ brisbane ⁄ ⁄ . as shown in table , the pa and ns genes of all the high yield reassortants examined are derived from wt, b ⁄ brisbane ⁄ ⁄ , not from the donor, b ⁄ panama ⁄ ⁄ . this indicates that in this reassortment, the pa and ns genes are not replaceable with that of the donor to obtain high yield viruses. this degree of incompatibility might be common in b reassortment, resulting in low donor ⁄ wt reassortants, such as : and even : reassortants that we obtained in this study. if this is the case, reverse genetics based on : configuration may not result in generating high yield b reassortants unless a variety of donor ⁄ wt combinations are designed. one can speculate that in influenza b viruses, the surface glycoproteins (ha and na) and some of the internal proteins are functionally more closely related than in influenza a virus, as was seen in that pa and ns genes of b ⁄ brisbane ⁄ ⁄ reassort together with the ha and na genes of the same parent (table ). in our recent study on a reassortment between b ⁄ lee ⁄ and b ⁄ panama ⁄ ⁄ , it appeared that ha shapes overall gene constellations of the resultant reassortants, namely the reassortants tend to have more internal genes from the same parent of ha, no matter which parent's ha is selected by antibodies against the surface antigens of the other parent (data not shown). because of success in influenza a virus reassortment with pr , it is generally believed that reassortant with : or : configuration is optimal for virus yield. this may be the case in most instances of influenza a reassortment, but is not necessarily so in b reassortment. as shown in this study, only a single donor gene is capable of improving the yield of vaccine strain by reassortment. influenza a ⁄ h n v has spread rapidly in all parts of the world in as a true pandemic. epidemic events in russia occurred during the last week of september starting from far east region (yuzhno-sakhalinsk). kaliningrad (the western most russian city) was the second starting point of the epidemic. during october the epidemic spread over the whole russian territory. in a short period the new virus started to change genetically as it began to adapt to human populations during this pandemic (http://www.who.int; http://www.euroflu.org). in the period from may to december , clinical samples (nasopharyngeal swabs and postmortem materials) of patients with influenza-like illness from different regions of russian federation were analyzed to confirm the diagnosis using real-time reverse transcription pcr (rrt-pcr). clinical nasopharyngeal swabs and bronchoalveolar lavage and post mortal fragments of trachea, lungs, bronchi, spleen from saint petersburg hospitals and basic laboratories of federal influenza center were included in this study. all specimens were taken from patients with influenza-like illness or viral pneumonia. specimens were tested by rrt-pcr according to cdc protocols, i.e. using superscript iii platinum one-step qrt-pcr system (invitrogen) with primers and probes for infa, h seasonal, and h sw (biosearch technologies). in addition, the test-systems 'amplisense influenza virus a ⁄ b-fl' and 'influenza virus a ⁄ h -swine-fl' for pcr-detection, typing and subtyping of influenza viruses were also used. these test-systems are produced by central institute of epidemiology, moscow, russia and recommended by russian ministry of health as tests for influenza diagnosis. sequencing was carried out on an abi prism -avant genetic analyzer (applied biosystems, usa) with bigdye terminator cycle sequencing kit. phylogenetic analysis was performed using programs vector nti . (invitrogen) and mega . (psu, usa) by maximum likelihood with the tim+i+g model for ha, and -hky+i+g model for na. evolutionary model was selected by akaike information criterion (aic) in model-test (posada, crandall, ). statistical reliability of tree branches was evaluated by bootstrap test ( replications). immunohistochemical study was performed using novalink antibodies to ha and np with novocastra visualization system. influenza virus a ⁄ h n v rna was detected in patients with severe form of influenza-like illness and fatal cases. out of pcr-confirmed flu recovered cases % were patients under years of age, % were aged - years, and % were older than years. mean age of recovered patients was ae years (from month to years). viral rna in postmortem materials was detected mostly in lung tissue ( % of specimens) and trachea fragments ( %), and less commonly in spleen ( %). mean age of the deceased with confirmed flu (h n v) infection was ae years with age ranging from months to years. in % of fatal cases, influenza was complicated by viral or secondary bacterial pneumonia. median time from the onset of illness until death was days. according to our data, % of patients died had diabetes, ae % were obese, and % were pregnant women in the nd or rd trimester. ha and np were detected by immunohistochemical assay in lung tissue of dead patients with confirmed influenza virus a ⁄ h n v infection. ha and np was revealed in the endothelium of different sized blood vessels (capillaries and arterioles). these influenza virus proteins were also detected in some tissue macrophages apart from epithelium and endothelium. the localization of the two proteins was different: ha is mostly localized in cell membrane and cytoplasm, and np -mostly in the nucleus. here we present data on molecular genetic characteristics of strains of pandemic virus, strains obtained from clinical specimens, and from post mortal ones isolated in the research institute of influenza. all the strains studied contain the s n substitution in m protein, which indicates resistance to the adamantane antivirals, and have no h y substitution in the neuraminidase, which indicates resistance to oseltamivir. the phylogenetic analysis showed that russian viruses were similar to influenza viruses a ⁄ texas ⁄ ⁄ and a ⁄ california ⁄ ⁄ (ha similarity ae %). all russian viruses could be divided in two clusters: the first one includes viruses similar to the reference strain a ⁄ california ⁄ ⁄ , and the second one, which is the majority of viruses analyzed includes strains with substitutions ha s t, na n d, v i, and ns i v (figure ). bootstrap support was . the isolates with ha s t substitution can be classified in one of the five minor genome variants of a ⁄ h n v viruses found in the united states and mexico in . several viruses had strain-specific substitutions in antigenic sites sb and ca and the mutation d g in ha receptor-binding site. the substitution of amino acid residue asp to gly at position of ha was found in eight of eleven isolates ( %) from postmortem lung and trachea samples and two of forty isolates ( %) from nasopharyngeal swabs of patients with severe course of the disease. appearance of amino acid substitutions in the ha receptor-binding site (d e and d g ⁄ e) could be associated with influenza virus passaging on eggs. five strains that contained g at position of ha were isolated from post mortal specimens on mdck cells in this study, thereby excluding the possibility of substitution appearance hence to virus adaptation on eggs. in order to reveal genome changes in a(h n )v, strains isolated on the territory of russian federation during the pandemic, full genome sequences from genbank, and research institute of influenza database were analyzed comparing two groups of viruses (isolated before and after sept ). nine amino acid changes observed predominantly in late pandemic strains were found. five of them (s p, s n, d g, v i, v i) reside in ha, two in na (i v, n k), two in pb (k n, t i), and one in pa (f l). towards the end of the epidemic the viral population had demonstrated statistically certain rise in number of strains containing mutations in four genes. difference between groups was statistically significant (chisquare test, p = ae ). if v > ae , than difference between early and late strains is statistically significant. additionally fisher's test determined whether 'early strains' and 'late strains' differ significantly in the proportion of 'no mutation event' and 'mutation event' attributed to them in each particular position. all calculations were performed in fisher_tk freeware by vladimir belyaev similar to calcfisher (haseeb, ) fully described here (http://www.jstatsoft.org/v /i /paper). we have selected positions with statistically significant amino acid changes in late strains (p-value ae ). according to full genome analysis of influenza virus a ⁄ h n v strains, seven clades were distinguished, but the divergence between representatives of different clades remained small. (figure ). besides the strain a ⁄ perth ⁄ ⁄ also contains substitution s f in the same ha antigenic site. according to data obtained, the epidemic in russia was caused only by influenza virus a ⁄ h n v. unlike the previous epidemic periods when most severe influenza cases were registered among the children under years and among elderly people aged over years, the first wave of pandemic due to influenza virus a (h n )v resulted in increased level of mortality mainly among the people aged - years. though all pandemic viruses showed comparative genetic homogeneity, some evolutionary trends could be outlined. for clarification of the exact pathogenic role of mutation d g in ha receptor binding site, further studies are necessary. full-genome analysis of influenza virus a ⁄ h n v strains circulating in the southern hemisphere in the new epidemic season revealed the phylogenetic subgroup distinguished by seven substitutions in inner proteins (pb , pb , np, ns ) and sa antigenic site of ha (n d). the changes revealed could be caused by adaptation of the virus to an immunized human population. nasal and throat swabs (placed in ml mem and frozen at ) °c until use for viral rna extraction and tissue culture inoculation) were collected from patients with febrile illness, i.e., > ae °c. samples were received from clinics in us embassies and us military laboratories located throughout the world since the initial who declaration of novel h n outbreaks as a global pandemic on june , . viral isolates were obtained from inoculating cultures of mdck cells with ae - ae ml viral suspensions collected in mem originated from patients after - days incubation. [ ] [ ] [ ] [ ] due to low viral titers in normal clinical samples, most of full viral genome sequences were derived from viral stocks obtained by tissue culturing passages (mdck, - times). viral rna was extracted from clarified supernatant fluid of nasal ⁄ throat swabs or mdck cultures using the 'charge-switch' rna extraction system based on the user manual protocol from the manufacturer (invitrogen inc., ca, usa). total rna was eluted into volume equal to original sample volume, i.e., ll starting viral supernatant used to yield final ll rna in molecular grade water (invotrogen inc.) and stored at ) °c until tested. generating ⁄ preparing overlapped cdnas for full genome coverage of novel h n viruses by multiple rt-pcr amplifications the first step in the high-throughput sequencing pipeline for full influenza genome sequences was to establish a robust rt-pcr amplification scheme consisting different rt-pcr primer pairs covering all rna segments to ensure % amplification coverage of full viral genomes of all the incoming targeted viruses (houng, hs. , submitted for publication). extracted viral rna ( ll), derived from mostly mdck culturing stock or clinical sample containing sufficient viral load (> infectious units per ml) was added to primer-free rt-pcr total master mixture ( ae ll) for each virus followed by adding primer pair ( ll, pmole ⁄ ll per primer). rt-pcr was then performed: rt reaction through two hold-steps ( °c, minutes and °c, minutes); cycling amplifications ( °c for seconds, °c for seconds, °c for ae minutes). specific cdna amplicons corresponding to each individual primer pair were routinely monitored and visualized by agarose gel electrophoresis. pooled cdna products ( - lg) from each viral rt-pcr amplification run were used as sequencing substrates according to the roche flx user manual and bulletins by incorporating adaptors containing individually multiplex identifier [mid]-key assigned to each individually pooled viral cdna. up to different mid-keyed viral cdna were further pooled together to be clonally amplified on capture beads in water-in-oil emulsion micro-reactors (em amplifications), and pyrosequenced using one of two regions of a · mm picotiterplate. for each individual viral genome containing multiple assemblies ( rna segments), we obtained sff file(s) containing raw sequencing reads from which nucleotide sequence data and phredlike quality scores were extracted. on average, ae - ae % of - million mid-key specific nucleotides were extracted and mapped for consensus genome sequences. roche gsmapper (v. . and . ) software was used to assemble all sequencing raw data and sff files into consensus sequences. new reference mapping projects were created to assemble each individually mid-keyed viral cdna into consensus viral sequences. one of the earliest h n genomes of california origin, a ⁄ california ⁄ ⁄ (h n ), deposited in genbank, was routinely employed as a reference genome sequence for most of gsmapper projects. the resultant consensus sequences obtained were further verified and validated through the ncbi annotation utility check and ultimately deposited to the ncbi influenza database, genbank. nucleotide sequences specific to each individual rna gene were aligned by the geneious pro . . software (http://www.geneious.com). trees were built based on the tamura-nei genetic distance model using the neighbor-joining method with no outgroup used via geneious pro . . . phylogenetic trees of the h n genomes were constructed by importing fasta files containing specific concatenated target sequences of pb , pb , pa, ha, np, na, mp, and ns from each individual virus into the geneous pro software and going through the sequence assembling and tree building steps. high-throughput pyrosequencing of pooled novel h n cdnas by roche flx system up to viral cdnas could be routinely sequenced to completion for different full viral genomes from a single roche flx picotiter plate by utilizing the combination of pico-titer plate's two distinct regions as well as different mid-keyed adaptors. the 'shotgun' sequencing approach employed in this study is a feasible method to viral isolates (n) sequence multiple pooled h n viral genomes. for each pyrosequencing experiment, approximately - passed key reads (single fragment per bead) were obtained that yielded readable nucleic acid sequences. among those close to a million passed key reads, only - passed key reads had an average sequencing read length of > bps, defined as 'long reads' ( bps · reads = total of million bases of nucleic acid sequences) that were used to assemble into influenza genome sequences. mathematically, - million bases of raw sequencing data from each single roche flx experiment would provide sufficient sequencing bases to cover full genome sequences with approximate - · of sequencing depth coverage of influenza a with average genome size of bps for the total of eight segmented rnas. so far, more than full h n genomes sampled worldwide have been successfully sequenced and deposited in the ncbi database by division of viral diseases, walter reed army institute of research (wrair). the bioinformatics derived from unique viral genome sequences generated from this study based on constant rt-pcr amplification scheme and identical roche pyrosequencing protocols provide a reliable data set in predicting the evolutionary patterns of pandemic viruses. wrair received clinical samples from us embassies and military personnel throughout the world since the initial who announcement of novel h n outbreaks. nearly equal distributions of sequenced viruses derived from three broadly categorized geographic regions, north america, central ⁄ south america, and asia ⁄ europe ⁄ africa (data not shown). besides the geographic distribution pattern of viral isolates, figure displays the viral isolation time lines of all the sequenced viruses reflecting two peaks that coincided with two waves of pandemic infections, early-mid summer and fall of . phylogenetic trees of the eight influenza a segments of all sequenced viruses were tentatively generated. it was found that the substitution frequencies per site for the ha, na, and ns genes are at much higher rate than the other five genes, pb , pb , pa, np, and mp genes (data not shown). the observed higher genetic variations for ha and na genes of h n are consistent with the historical genomic and epidemiological dynamics data of human influenza a revealing higher temporal fluctuations in ha and na genes. [ ] [ ] [ ] [ ] analysis of full influenza genomes containing concatenated eight complete rna segments revealed the existence of two distinctive genetic clades in circulation since the beginning of pandemic, as shown in fig-ure . it is noteworthy that all viruses of mexico and california origins (clade shown at the top of figure ) were isolated at the beginning of pandemic prior to the isolation of all other viruses belonging to the second genetic clade . , discussion during the past decade, the advance of dna sequencing technology, such as development of ngs, in making full viral genome sequences readily available have enabled study of far broader and more detailed aspects of evolutionary change for any new emergent infectious pathogen. the massive sequencing capacity of roche flx system allows simultaneously process and sequence millions of individual cdna molecules, in contrast to processing and sequencing individual cdna fragments by conventional sanger sequencing method. within a short period of few months since the beginning of the pandemics, wrair accomplished large number of representative h n full genomes of worldwide origins via roche flx system. sequencing data derived from this study illustrates a much higher genetic variation rate for ha and na genes of h n that is compatible to the higher temporal fluctuation rate for ha and na genes of seasonal influenza a derived from decades of intensive monitoring and comparison studies and analyses. [ ] [ ] [ ] [ ] following the mexican and us reported cases, confirmed outbreaks of swine h n rapidly proliferated and spread throughout europe, asia, africa, and south america, most probably via global airline travel. , it seemed that new cases in the us and most cases throughout the world had been clinically mild relative to the initial reported cases in mexico. [ ] [ ] [ ] [ ] here we demonstrate through the phylogenetic relationship of sequenced h n full genomes that the clinical isolates could be divided into two different clades of viruses, i.e., the clade genetic group contains only viruses isolated at the beginning (march ⁄ april , mexico and california) of pandemics and the rest of other viruses all belong to the nd genetic group, clade . thus, it's likely that the currently circulating h n of clade causing worldwide infections is genetically different from the initial h n isolates that caused the early infections in mexico and california. , introduction a pandemic influenza virus ( h n ) was recently introduced into the human population. the hemagglutinin (ha) gene of h n is derived from 'classical swine h n ' virus, which likely shares a common progenitor strain with the human h n virus that caused the pandemic in . since antigenic changes of influenza virus ha occur more slowly in swine than in humans, we hypothesized that h n might still retain an antigenic structure similar to that of h n or the early isolates of its descendants. in this study, we compared ha antigenic structures of h n and human h n viruses by a molecular modeling approach to demonstrate the existence of shared epi-topes for neutralizing antibodies. we found that has of h n and the h n virus shared a significant number of amino acid residues in known antigenic regions. from this observation, we hypothesize that the h n ha antigenic sites will be targeted by antibody-mediated selection pressure in humans in the near future. we further discuss possible directions of antigenic changes in the evolutionary process of h n . sequence data of ha genes modeller v was used for homology modeling of ha structures. after models of the ha trimer were generated, the model was chosen by a combination of the mod-eller objective function value and the discrete optimized protein energy statistical potential score. after addition of hydrogen atoms, the model was refined by energy minimization with the minimization protocols in the accelrys discovery studio . software package using a charmm force field. steepest descent followed by conjugate gradient minimizations was carried out until the root mean square gradient was less than or equal to ae kcal ⁄ mol ⁄ a. the generalized born implicit solvent model was used to model the effects of solvation. the ha model was finally evaluated by using procheck, whatcheck, and verify- d. custom-made programs were developed with the ruby language and used for investigating the numbers of potential n-glycosylation sites and candidate codons (cand ) in ha sequences. it is known that the h ha molecules have four distinct antigenic sites: sa, sb, ca, and cb. , as a result, these sites consist of the most variable amino acids in the ha molecule of the seasonal human h n viruses that have been subjected to antibody-mediated immune pressure since its emergence in , although it was absent in humans from to . to investigate the structures of these antigenic sites of h n , d structures of the ha molecules of sc , the recent seasonal human h n virus (br ), and h n (ca ) were constructed by a homology modeling approach, and compared by mapping all the amino acid residues that were distinct from those of sc ha (data not shown). we found that most of these antigenic sites of br ha predominantly contained altered amino acid residues if compared with sc . by contrast, amino acid residues at these positions were relatively conserved in ca ha when compared with sc ha. notably, the sa and sb sites, which contain many amino acids involved in neutralizing epitopes near the receptor binding pockets, remain almost intact ( table ), suggesting that antibodies raised by natural infection with sc or its antigenically related descendant viruses play a role in specific immunity against ca . these observations lead us to hypothesize that such antigenic sites involving the conserved amino acids will soon be targeted by antibody-mediated selection pressure in the human population. based on this hypothesis, we speculated that h n would undergo patterns of amino acid substitutions in ha similar to those seen in seasonal human h n viruses during its epidemic period (i.e. those that have been substituted since ) (figure ) . we then predicted possible amino acid substitutions of h n from the sequence similarity of the antigenic sites. for example, both sc and ca had an asn residue at position in the sa site. for sc , the residue at this position has altered from asn to lys since . combining these two facts, it seems reasonable to hypothesize that ca will also undergo an amino acid substitution from asn to lys at position in the future. interestingly, we found that some of the recent variants of the h n virus have indeed undergone substitutions identical to those predicted in figure . it is important to monitor whether such variants will be selected and survive in sustained circulation in humans. next, we analyzed the acquisition of potential n-glycosylation sites associated with antigenic changes. previously, we reported that cand sites, a set of three codons that require single nucleotide substitution to produce n-glycosylation sequons, were important motifs to rapidly acquire n-glycosylation sequons. therefore, we investigated the number and location of potential n-glycosylation sites and cand sites in h n ha. we found that ca also had a single n-glycosylation sequon at the same position in the globular head region of ha, and lacked the multiple n-glycosylations that have been observed in the antigenic changes of the human h n virus during the early epidemic of this virus. we also found that ca ha possessed three cand sites that were present at the same position in sc ha (positions of the first asn residue, , , and ). of these, the cand sites with positions at and had actually become potential n-glycosylation sites in human h n viruses. this result suggests the likelihood of additional n-glycosylation at these sites during future antigenic changes of h n ha. notably, some of the recent h n variants (as of march , ) have an additional n-glycosylation sequon at position , where the h n virus readily acquired an n-glycosylation site during its circulation. the present study suggests that the antigenic structure of h n ha is similar, at least in part, to that of the h n ha. the and h n has share unique three-codon motifs that are important to readily acquire n-glycosylation sequons in their globular head region. based on these similarities, we predicted possible amino acid substitutions that might be associated with future antigenic changes of h n , and confirmed that such substitutions occurred in some of the recent variants of this virus. the present study provides an insight into likely future antigenic changes in the evolutionary process of h n in the human population. influenza viruses are classified into three types, a, b, and c, based upon the antigenic properties of nucleoproteins and matrix proteins. influenza a virus infects a wide range of hosts, including human, bird, swine, equine, and marine mammal species, while influenza b and c are less pathogenic than influenza a and are mainly found in humans, although there is evidence that they can also infect other species. influenza a has evolved in association with its various hosts on different continents for extended periods of time. to survive as a successful pathogen, the influenza viruses have developed a number of mechanisms, including antigenic mutation and genome reassortment, to continuously evolve and evade the surveillance of the host immune systems. antigenic and genetic analyses have provided important insights into the molecular dynamics of influenza virus evolution. however, a comprehensive understanding of influenza viral genetic divergence and diversity remains lacking. neuraminidase (na) is a major surface glycoprotein of influenza a and b, but is absent in influenza c. it plays a key role in virus replication through removing sialic acids from the surface of the host cell and releasing newly formed virions. influenza a viral na genes are classified into nine subtypes (na -na ) based upon their antigenic properties, while na genes of influenza b are not classified into subtypes. furthermore, most na subtypes of influenza a have evolved into distinct lineages and sub-lineages, which correspond to specific hosts or geographical locations. in this study, we conducted large-scale analyses of influenza na sequences in order to infer their evolution and to identify lineages (or sub-lineages) of influenza a viruses. a total of na sequences that excluded laboratory recombinant sequences were downloaded from genbank. sequences were aligned with muscle and mafft. the alignments were adjusted manually using translatorx, based upon corresponding protein sequences. phylogenetic analyses were conducted using the maximum-likelihood (ml) method in raxml. a set of perl scripts were written by us to facilitate this computational analysis. lineages and sub-lineages were determined based on the topology of the ml trees. additional information such as hosts, geographical regions, and circulation years were also considered in the classification. we used the same lineage nomenclature as described in, but with the following modifications: a single digit is used to represent one of the nine subtypes and a letter is used to represent a lineage; a sub-lineage is also represented using a digit; a dot is used to separate a lineage and a sublineage. for example, a. means na subtype, lineage a, and sub-lineage . the time of most recent common ancestor (tmrca) was estimated using the bayesian mcmc method in beast. in all cases, we employed the gtr + u nucleotide substitution model, in which the first and second codon positions are allowed different rates relative to the third codon position. all data sets were analyzed under a relaxed molecular clock and the bayesian skyline population coalescent prior. the maximum clade credibility (mcc) tree across all plausible trees was computed from the beast trees using the treeannotator program, with the first % trees removed as burn-in. phylogenetic analysis based upon na sequences revealed two large groups corresponding to influenza a and b, respectively ( figure a ). within influenza a, two subgroups were found, one consisting of na , na , na , and na and the other consisting of the remaining five subtypes. subtype na was found to be a sister subtype of na , na being a sister subtype of na , and na a sister subtype of na . finally, each na subtype forms a distinct cluster, indicating its genetic uniqueness. influenza a and b viral na were estimated to have diverged around years ago ( figure b ). however, it had large % hpd values which ranged from years to years ago. the na subtypes of influenza a diverged from more than to several hundred years ago. the time of most recent common ancestor (tmrca) of each subtype of influenza a virus was generally recent and ranged from the calendar years to (figure b ). in addition, the tmrca for influenza b viral na was dated back to . a total of lineages were identified in influenza a (table ) . three lineages, a, b, and c, were identified for na based upon the tree topology. linage a originated from avian viruses and was further divided into sub-lineages: a. , a. , a. , a. , and a. . linage b consists of north american swine influenza viruses whereas c is a human lineage. two large lineages, a and b, were identified in na . lineage a is a human-specific lineage. interestingly, five major swine clades were observed within this lineage. lineage b is an avian-specific lineage, and consists of sub-lineages, b. , b. , and b. . three lineages were found in na . lineage a was found in north american avian, b in eurasian ⁄ oceanian avian, and c also in avian, but it does not show any geographical pattern. for na , na , and na , each was classified into lineages, one found in north american avian ( a, a, a) and the other in eurasian ⁄ oceanian avian ( b, b, b). three lineages identified respectively in na and na are north american avian ( a, a), equine ( b, b), and eurasian avian ( c, c). na was also found to have lineages: north american avian ( a), eurasian ⁄ oceanian avian i ( b), and eurassian ⁄ oceanian avian ii ( c), respectively. in this study, we conducted large-scale phylogeny and evolutionary analyses using influenza viral na sequences. the results showed that divergence between influenza a and b viruses occurred earlier than between any influenza a subtypes. this observation was consistent with previous findings based upon phylogenetic analysis of the ha gene, one of the most important genes related to host infection. within influenza a, two sub-groups were found, one consisting of na , , , and and the other consisting of the rest of five subtypes (na , , , , ) . this observation does not agree with the result described by liu et al., where na subtypes , , , , and formed one group and the remaining four subtypes (na , , , and ) formed the other group. this difference is apparently caused by the fact that an outgroup was not used in their phylogenetic analyses. in the present study, both influenza a and b viral na sequences were included in the analysis. high bootstrap values were obtained for major groups, indicating that the inferred evolutionary relationship should be highly reliable. classification and designation of the lineages and sublineages within the influenza a virus are essential for studies of viral evolution, ecology, and epidemiology. a total of lineages were identified within nine influenza a viral na subtypes and with the majority of the identified lineages found to be host or geographic specific or both. our results demonstrated a comprehensive view for the evolution of na genes and provided a framework for the inference of evolutionary history of pandemic viruses and for further exploring of viral circulations in multiple hosts. for example, the global pandemics of human h n in , h n in , the pandemic of human h n virus in , the crisis of h n hpai in hong kong in , and swine-origin h n influenza in , all can be mapped onto the lineages and sub-lineages identified in this study. such information will facilitate not only identification of known genetic origins but also early detection of novel influenza a viruses. influenza viruses constantly evolve to avoid the human immune pressure in the process of antigenic drift. through sequencing of viral genomes, the rates and direction of virus evolution can be observed. moreover, comparison of protein sequences allows us to determine amino acid substitutions that are related to immune pressure and antigenic drift. the creation of global influenza genetic databases, along with concurrent development of analytical tools, allows the comparison of multiple influenza virus strains. the main aim of this study was to perform antigenic and genetic comparison of pandemic influenza viruses (h n ) isolated during the - pandemic in ukraine and in other countries. nasopharyngeal swabs and autopsy materials collected from infected patients were received from the areas of ukraine. in addition, field isolates of influenza viruses from the ⁄ season and strain specific serum were used for identification by hemagglutinin inhibition assay. influenza viruses were identified and subtyped using real-time rt-pcr analyses using cdc primers and adopted protocols. sequencing was performed in two world health organization (who) influenza collaboration centers (centers for disease control and prevention, atlanta and national institute for medical research, london). hemagglutinin inhibition assay was conducted using chicken and guinea pig red blood cells following standard who protocols. the all ukrainian isolates of influenza viruses, which were isolated in ukraine during august-november , were identified as a ⁄ california the phylogenetic analyses confirmed the evolutionary relationship between ukrainian isolates and viruses from other countries, which were isolated during the first wave of the pandemic. high genetic and antigenic conservation of pandemic influenza viruses from ukraine and other countries also were demonstrated. considering that the emergence of the novel pandemic influenza strain occurred in countries of northern hemisphere during summer, it was very interesting and significant tracking the dynamics of genetic changes in influenza viruses, which were isolated at the beginning of epidemic and those isolated during the rise of the epidemic in ukraine. influenza a virus causes moderate to severe epidemics annually and catastrophic pandemics sporadically. due to the evasiveness of the influenza virus and the nature of its genome (eight single-stranded and negative-sense rna segments), it is essential to understand the evolution of this important pathogen. influenza virus evolves by two major mechanisms: mutation and reassortment. antigenic and genetic analyses have revealed partially the molecular dynamics of influenza virus evolution. , however, important questions, such as how many genotypes in the influenza a virus, remain unanswered. one of the major issues pertaining to this genotyping problem is how many lineages or sub-lineages can be determined for a subtype and according to what criteria. because of the unique structure of the influenza a viral genome, the computational genotyping methods developed for other viruses cannot be applied to the influenza virus. constructing phylogenetic trees is a powerful technique for the identification of evolutionary groupings (i.e., lineages ⁄ clades). however, for large trees, it is hard to determine how many lineages and the boundaries for each lineage. in this regard, multivariate analysis methods, such as multidimensional scaling (mds) and model-based hierarchical clustering, both taking advantage of dimension reduction and visualization, can complement conventional phylogenetic methods. hemagglutinin (ha), the fastest evolving segment, is recognized as the most important gene in the influenza virus that plays a key role in viral pathogenesis. however, we have only limited knowledge of lineages and sub-lineages occurring in the hemagglutinin (ha) gene of influenza a virus, although much effort has been made in assigning clades or sub-clades in highly pathogenic avian influenza (hpai) virus ha. in this study, both model-based hierarchical clustering and phylogenetic methods were used for sequence analysis. one objective for this study is to explore and develop a more accurate lineage approach for further comprehensive influenza lineage and genotype analyses. a total of hemagglutinin (ha) sequences (approximately nucleotides long), excluding laboratory recombinant sequences, were downloaded from genbank as of march, . sequences were aligned with muscle and mafft. the genetic distance matrix of all pairwise sequences was computed using the k p model under mega . . we then used the distance matrix as input to the cmdscale module in r . . for the mds analysis. the principle coordinates resulting from mds were used for the model-based hierarchical clustering analysis, again in r . . (the r foundation. available at: http://www.r-project.org/). the bayesian information criterion (bic) values were computed based upon ten different statistical data models -eii, vii, eei, evi, vei, vvi, eee, eev, vev, and vvv. the highest bic value was used to determine the number of clusters in the given sequence data. phylogenetic analysis was conducted using maximumlikelihood (ml) in raxml. raxml uses rapid algorithms for bootstrap and maximum likelihood searches and is considered one of the fastest and most accurate phylogeny programs for large-scale sequence analysis. all the analyses were conducted on the supercomputer cluster (holland computing center, http://hcc.unl.edu/main/index.php). the trees were visualized in figtree (version . . ) . lineages and sub-lineages were determined based on both the topology of the ml trees and model-based clustering results. additional information such as hosts, geographical regions, and circulation years were also considered in the classification. we used the same lineage nomenclature as described in, with the following modifications: lineage analysis was conducted for each ha subtype, which agrees with the convention of influenza virologists that ha subtypes were identified in influenza a virus; ha lineages are represented with digits and letters, where the digit(s) represent one of the subtypes and a letter represents a lineage; here, we present sub-lineages or sub-sub-lineages also in digits, with smaller numbers representing earlier lineages or sub-lineages within the same subtype (e.g., lineage occurs earlier than lineage ); the digit is used to indicate inclusion of ancestral viruses in a lineage (or sub-lineage); a dot is used to separate lineages, sub-lineages, and sub-sub-lineages. for example, a. ae means ha subtype, lineage a, and sub-lineage , and sub-sub-lineage . the sub-lineage level can be extended as necessary. the model-based clustering method corroborates commonly used phylogenetic methods in lineage and sub-lineage assignment. here we use the h subtype as an example to show the lineage and sub-lineage assignment. the bayesian information criterion (bic) reaches its maximum when the number of clusters for h equals , regardless of which mode we choose ( figure a ). therefore, based on bic, the optimal number of clusters for the h subtype is . as a result, a total of clusters based upon the vvv model were identified ( figure b) . a significant correlation was found in lineage assignments by the phylogenetic method and the model-based hierarchical clustering method ( figure b,c) . lineages a and b were identified for h , which correspond to north american avian and eurasian avian, respectively. lineage a was further divided into sub-lineages, a. , a. , where a. is the ancestral sub-lineage in a. based on both model-based hierarchical clustering and phylogenetic analyses, a total of distinct lineages were identified among subtypes, averaging out to be ae lineages per subtype ( table ). the majority of the identified lineages were found to be host or geographic specific or both. for example, three lineages, a, b, and c, were identified for ha . lineage a was further divided into two sub-lineages, a. and a. . the a. is swine-specific, whereas a. is a human pandemic h n sub-line- how to accurately identify an evolutionary lineage of influenza a viruses is challenging. one commonly used approach is molecular phylogeny, where phylogenetic trees are constructed, and the tree topology is used for lineage determination. here, we used a bayesian model-based clustering method, along with phylogenetic methods, to decide lineages and sub-lineages of influenza a viruses based upon sequence data. the results demonstrated that the modelbased clustering method corroborates phylogenetic methods and increases the accuracy of lineage assignment. one salient feature of this study is its large-scale analysis of all available influenza a hemagglutinin sequences. a total of distinct lineages and sub-lineages were classified; the majority of them were found to be host or geographic specific. this observation agrees largely with previous findings. we are conducting further analyses of other influenza a segments and expect to identify their lineages and create a comprehensive genotypes database for all influenza a viruses. such information will allow us to detect the genetic origin of newly found viruses, track their genetic changes, and identify potential genome reassortments. a hierarchical nomenclature system has been proposed and adopted for hpai ha clades and sub-clades by who influenza surveillance centers. wan et al. also proposed a hierarchical approach for influenza a viral genotypes system. the work presented here is one of the first steps towards the development of a nomenclature system for influenza a virus lineages (at the segment level) and genotypes (at the genome level). whether the naming system will be accepted and used by the influenza research community is more challenging than the lineage analysis itself. identification of the genetic origins of influenza a viruses will enhance our understanding the evolution and adaptation mechanisms of influenza viruses. the phylogenetic analysis is the traditional approach to identify the influenza progenitor. first, the nucleotide sequences are aligned using multiple sequence alignment methods, such as clustalw, muscle, and t-coffee. second, phylogenetic analysis is performed on these aligned sequences to infer their evolutionary relationship using neighbor-joining (nj), likelihood, or bayesian inference. bootstrap analyses or computation of posterior probability are usually applied to estimate the phylogenetic uncertainty. however, this phylogenetic analysis is time consuming due to intensive computations in multiple sequence alignments and phylogenetic inferences. it is difficult to perform an analysis using this method on a large dataset, for instance, with more than taxa, as is the common case for influenza studies. alternatively, blast is applied to identify the prototype genes in the database. blast determines a similarity by identifying initial short matches and starting local alignments. since influenza viral sequences have very high similarities, especially for most conserved regions, blast usually generates a large number of outputs, which will not be helpful for progenitor identification. since blast is a local sequence alignment, the results from blast may not reflect the global evolutionary information between the sequences. the blast scores cannot be used to define the evolutionary relations between viruses, especially in the context of the entire genetic pool. recently, we have developed a distance measurement method, complete composition vector (ccv), that can calculate genetic distance between influenza a viruses without performing multiple sequence alignments. , we also adapted the minimum spanning tree (mst) clustering algorithm for influenza reassortment identification. the application of this approach in the analyses of pb genes of influenza a virus showed that the integration of ccv and mst allows us to identify the potential progenitor genes rapidly and effectively. based on these results, here we develop a webserver called ipminer for influenza progenitor identification. ipminer can identify potential progenitors for a query sequence against all public influenza datasets within a few minutes. in order to improve the computing efficiency, distance matrices were pre-computed by ccv, and they include for ha (h to ), for na (n to n ), and one for each of the internal gene segments (pb , pb , pa, np, ns, and mp). these pre-computed matrices will be updated weekly. ipminer just needs to compute the query matrices for a query sequence and sequences in the database. the standalone ccv program is also available at http://sysbio.cvm.msstate.edu/ipminer. in order to identify the influenza progenitor genes, ipminer first integrates the query matrix and a corresponding pre-computed matrix into a full distance matrix, which is then clustered by mst clustering algorithm. we adapted the threshold we measured previously in mst, u + nr, where u is the average distance and r is the standard deviation of a cluster. as a result, mst will generate a hierarchical structure for the clusters. in each cluster, we will randomly select viruses or % of the cluster size if this cluster has more than viruses. ipminer will return the viruses with the smallest distances when the search reaches to the lowest level (the largest n) in this hierarchical structure. our analyses have shown that the level has generally yielded good results for influenza a viruses. to visualize the overall mst structure, ipminer applies multi-dimensional scaling (mds) method to project all the viruses in the genetic pool onto a two dimensional graph, and the precursor viruses are marked in different shapes ( figure ). the users can select other prototype viruses from the graph for further phylogenetic analyses. a single job with one query sequence takes < min. the genbank identifiers and associated genetic distances and sequence identities are displayed. the users can download the sequences for the identified precursor viruses as well as those from the prototypes viruses. in addition, for the users' convenience, ipminer generates a phylogenetic tree using nj method implemented in phylip to illustrate the phylogenetic relationship among the query sequence(s), the identified progenitors, and the selected prototypes viruses. the programs in this solution package are written in java. the shell scripts are written in korn shell script in order to achieve high performance. cascading style sheets (css) are used for a consistent look across the pages. this also enables to change the overall design just by replacing the css definition file. php has been used as server side scripting and is written in java. in order to achieve high performance for computing in a genomic scale, we apply hash function or a binary tree, which enables that the precursor identification has a time complexity of o(n). for single queries, the users can visualize the results online. for batch queries of multiple sequences, the results will be sent to the users by e-mail. ipminer has been tested on microsoft internet explorer, mozilla firefox, and safari. the users need javascript to obtain full function of ipminer server. the webserver is available at http://sysbio.cvm.msstate.edu/ipminer. in summary, ipminer webserver has three major computational features for influenza progenitor identification: (i) it calculates the genetic distances through ccv and identifies the viruses with the shortest ccv distances against the query virus to be the progenitor genes; (ii) it projects influenza viruses onto a two dimensional map, which illustrates the global relationship between the progenitor genes and other viruses in the genetic pool; and (iii) it performs phylogenetic analyses between the query virus, the identified progenitor genes, and other selected prototype viruses. ipminer provides a user friendly web service for influenza progenitor identification in real time. the gisaid initiative offers an alternative to current public-domain database models in response to growing needs of the global influenza community for the sharing of genetic sequence and associated epidemiological and clinical data of all influenza strains. gisaid's publicly accessible epifluÔ database is governed by a unique sharing mechanism that protects the rights of the submitter, while permitting ongoing research as well as the development of medical interventions, such as drugs and vaccines. for the gisaid initiative, the max planck institute for informatics (mpii) saarbrücken, germany, has developed a web portal that is accessible at http://www.gisaid.org featuring the gisaid epifluÔ database that offers a unique collection of nucleotide sequence and other relevant data on influenza viruses. the database is based on software by oracle and the dante Ò system by a systems gmbh, germany. extensive metadata are also collected for most isolates. the database provides features for searching, filtering specific datasets for download, and user friendly upload functionality. to uphold gisaid's unique sharing mechanism, all users must positively identify themselves. while access is free of charge, all users agree that they will not attach any restrictions on the data, but will acknowledge both the originator of the specimen and the submitter of the data, and seek to undertake to collaborate with the submitter. all uploaded sequence data are submitted to rigorous curation by the friedrich-loeffler-institute for animal health (fli), germany. the database has been live since september , . among its contributors are all five who collaborating centers for influenza who routinely contribute data in addition to using the epifluÔ database for their semiannual vaccine strain selection. to provide a complete picture of data, all data available in the public domain is routinely imported. as of october , , the rapidly growing gisaid dataset comprises nucleotide sequences (from isolates) with (from isolates) uniquely submitted to this database. software development is underway to continually extend the spectrum of available data analysis tools. the intergovernmental process of the nd world health assembly specifically mentions gisaid as a publicly available database for depositing virus sequence data. starting in , germany's federal ministry of food, agriculture and consumer protection will be the long-term host of the gisaid platform. the mpii will continue to develop the portal and database software and enable gisaid to act as a catalyst for the development of advanced bioinformatics software connected directly to the database. gisaid has become an indispensible resource for the international scientific community on influenza. the consortium will expand its activities and offers to catalyze research and development on a wide variety of issues pertaining to risk analysis, drug development, and therapy of influenza. options for the control of influenza vii ª blackwell publishing ltd, influenza and other respiratory viruses, (suppl. ), - the pandemic h n virus emerged in and spread rapidly throughout the world, principally affecting children and young adults. as this virus is new to the human population, it is important to determine if these influenza infections are more commonly associated with other respiratory pathogens compared to previously circulating influenza strains. co-infecting respiratory viruses may cause increased morbidity in individuals with pandemic h n , and may also be unwanted contaminants in influenza vaccines if original clinical samples containing these adventitious viruses are used to directly inoculate certified cell lines for vaccine production. to examine this issue, stored rna from original clinical samples (nasal swabs, nasal aspirates, throat swabs) from australian and new zealand subjects that were collected in that were positive for pandemic h n and samples collected in that were positive for seasonal influenza by real time pcr assay (using the cdc, usa kits), were subjected to a resplex ii -panel version . (qiagen) pathogen screen. the resplex ii assay detects common respiratory viruses, such as respiratory syncytial viruses (rsv a, b), influenza a and b viruses, parainfluenza viruses (piv - ), human metapneumo-viruses (hmpv), coxsackieviruses ⁄ echovirus (cvev), rhinoviruses (rhv), adenoviruses (adv b, e), coronaviruses (nl , hku , e, oc ), and bocaviruses. resplex ii uses a combination of multiplex rt-pcr, hybridization of pcr onto target specific beads followed by detection using luminex-xmap technology. original clinical samples were received at the center from who national influenza centers, who influenza collaborating centers, and other regional laboratories and hospitals from australia, new zealand, and the asia ⁄ pacific region. most samples were from australia and new zealand. these samples consisted of nasal swabs, nasopharyngeal swabs, nasal washes, throat washes, and throat swabs. all samples were stored at ) °c until rna was extracted. rna was extracted from ll of clinical sample using either the magnapure extraction system (roche, australia) or the qiaxtractor system (qiagen, australia) according to the manufacturer's recommendations with an elution volume of ll and stored at ) °c until used. a ll aliquot of rna was used to amplify the selected influenza virus gene using specific primers and probes as supplied by cdc (atlanta, usa) along with super-script iii platinum one-step rt-pcr reagents (invitrogen, australia). real time pcr detection was performed on a fast system with sds software (applied biosystems, ca, usa). a cut off of a cycle threshold (c t ) of or below was considered positive. resplex ii panel ver . detection the qiagen molecular differential detection (mdd) system was used, which combines qiaplex amplification (multiplex rt-pcr) with detection on the liquichip workstation (luminex's xmap microsphere based multiplexing system) and qiaplex mdd software according to the manufacturer's instructions. a low level cutoff was used ( ) to obtain maximum sensitivity. from the clinical specimens that were positive for influenza from by real time pcr, there were ( %) a(h n ) seasonal influenza viruses, ( ae %) a(h n ) viruses, ( %) b viruses, and ( ae %) viruses which were influenza a positive, but could not be typed. clinical samples from selected to study were all influenza a(h n ) pandemic positive by real time pcr. detection of influenza virus in respiratory samples was much lower with the resplex ii assay (using a low cut off of units) for pandemic influenza a virus ( ⁄ ; sensitivity ae %) and to a lesser extent for seasonal influenza a ( ⁄ ; sensitivity of ae %) and b viruses ( ⁄ ; sensitivity of ae %) when compared to real time pcr. there were relatively few co-infecting respiratory viruses with either pandemic h infections in ( ae %) or seasonal influenza infections in ( ae %) ( table ). the most common dual infection seen with pandemic h n viruses and seasonal b viruses was with cvev ( ⁄ ; and ⁄ ; , respectively) while for a(h ) viruses there were no dominant co-infecting viruses ( table ). in one case was detected with three respira- tory pathogens in the same sample, a year old female who had pandemic h n , cvev, and rhv, and in a seasonal influenza sample, one case with a triple infection was detected (bocavirus, piv and influenza b). the median age of subjects with co-infections was younger for both pandemic h n with a median age of years (range: months to years), compared to the full sample set which had a median age of years (range: months to years), while for the patients from with seasonal influenza viruses with co-infections they had a median age of ae years (range: months to years) compared to all samples which had a median age of years (range: months to years). there was good concordance in detecting influenza a and b in respiratory samples collected in between real time rt-pcr and the resplex ii system ( % versus > ae % for seasonal influenza a and b respectively). this data compares well with other studies such as li et al. who found that resplex ii had ae % sensitivity and % specificity for seasonal influenza a viruses and ae % sensitivity and % specificity for influenza b viruses. in contrast, the present study found only ae % sensitivity for the resplex ii detection of influenza a with the samples that were positive for pandemic h n by real time rt-pcr. a recent study by rebbapragada et al. also showed lower sensitivity for pandemic h n viruses in nasopharyngeal samples with the resplex ii system ( % sensitivity and % specificity) compared to other commercial platforms seeplex rvp ( % sensitivity and % specificity) and luminex rvp ( % sensitivity and % specificity). interestingly the latest version of the resplex system offered by qiagen the resplex ii plus panel ruo now has a separate target for the pandemic h n virus (mexico ). in terms of detection of other respiratory viruses such as piv- , piv- , rsv and hmpv, high sensitivities ( ae %, ae %, ae %, and %, respectively) and specificities ( ae - %) compared to taqman rt-pcr have been reported from testing of nasal wash and nasopharyngeal clinical samples. in both the seasonal influenza positive and the pandemic h n positive (by real time rt-pcr) clinical specimens, few other respiratory viruses were detected. only of the samples had another virus detectable and one had two other viruses, while in out had another virus and one had two other viruses detected from a total of influenza virus positive samples collected in each year. enteroviruses, coronaviruses, and parainfluenza viruses were most often found with both seasonal and pandemic infections. younger age appeared to be associated with co-infections with those subjects in with dual infections having a median age of only years compared to the study groups years; and similarly for , the median age for subjects with dual infections was only ae years compared to the study groups' median age of years. a study by chong et al. on nasopharyngeal swabs collected during - using resplex ii and luminex xtag rvp fast, they found dual respiratory virus infections in ⁄ ( ae %) of samples and only ( ae %) with triple respiratory viral infections; however, these were from cases with any combination of multiple respiratory viruses not necessarily influenza, although influenza positive cases were the most common respiratory virus detected ( ae % of all positive samples). given the low level and variety of viral co-infections along with both seasonal and pandemic influenza seen in this study, it is unlikely that influenza infections predispose subjects to particular respiratory viruses, but may still allow bacterial colonization, such as has been seen with severe and fatal cases with pandemic h n with various bacteria including streptococcus pneumoniae, streptococcus pyogenes, staphylococcus aureus, or haemophilus influenzae. , low levels of other respiratory viruses along with the finding that certain cell lines (like the mdck -cells used in this study) do not propagate a number of these viruses (e.g. rsv a and b, rhinoviruses, coronaviruses), but do propagate others (e.g. parainfluenza ) should make testing for unwanted viruses that might be co-isolated with influenza viruses more focused and hence easier to detect and eliminate this isolate for future vaccine production. global influenza surveillance is one of the most important approaches to combat spread of disease. current laboratory methods for characterizing influenza are time-consuming and labor-intensive, and few viral strains undergo full characterization. even fewer strains from domestic poultry and swine or from wild aquatic birds are wellcharacterized. these strains are important for global surveillance since they are thought to be the precursors to pandemic influenza strains. we have designed a highthroughput global bio laboratory to address these surveillance needs. the goal of this project was to develop highspeed and high-volume laboratory capabilities for extensive surveillance and rapid and accurate detection and analysis of influenza. the workflow consists of surveillance, sample transportation, laboratory testing, data management and analysis. five robotic systems have been designed for this laboratory: sample accessioning, biobanking, screening, viral culture, and sequencing. sample accessioning logs barcodes, centrifuges, and aliquots samples are then sent to biobanking. the robotic biobank stores samples at ) °c and reformats tubes for screening. the screening system extracts rna and confirms the presence and subtype of influenza. aliquots of positive samples are sent to the viral culturing system for scale-up. finally, cultured samples are extracted and sent to the sequencing system for full genome sequencing. the sample accessioning, sequencing, and biobanking systems have been built, delivered, and validation processes are currently being completed. robotic screening and culturing systems have been fully designed and are ready to be built. a biosafety level -enhanced containment laboratory was built to enable the flow of samples containing highly pathogenic avian influenza viruses. in full operation, this approach to surveillance is designed to enable the sequencing of up to full virus genomes per year, more than the total of all full influenza genomes sequenced to date. the design of a robotic laboratory for influenza surveillance presents unique challenges and opportunities. before a robotic system is built, each assay is worked out on the bench top, each movement of the plates and reagents is defined, and the laboratory information management system (lims) must be able to address each step of the process. alternate assays are conceived for processes that are not automation-friendly. waste streams, worker safety, and space constraints are considered. each possibility is taken to reduce processes that have the potential to aerosolize or cross-contaminate influenza samples. instruments must be found that fit the capabilities needed. detailed specifications for each of the robotic systems were written including all the parameters listed above. once the systems are built, a long validation process takes place where the processes and instruments in each system are adjusted to function together properly. finally, a validation study is performed to ensure that the system is able to produce useful data for influenza research. the entire process takes months from start to finish for each robotic system and requires complete cooperation from a diverse team of researchers. the accessioning system logs initial sample information with the lims system. samples arrive in barcoded cryotubes. the liquid handler brings all samples up to a common volume and clarifies samples by centrifugation. samples are then transferred from screw-cap sample vials into storage plates containing individually punchable storage tubes. each tube ( ae ml) is individually identifiable with a d barcode on the bottom. six archive aliquots are made, and tubes are individually weld-sealed for storage. tips for aspiration are fixed and undergo a high-pressure plasma process between each use to sterilize tips and destroy nucleic acids. samples are stored at ) °c. each module has a capacity of remp plates or $ samples. the automated freezer system can assemble requested samples as -well plates while samples remain frozen. the screening system uses magnetic bead extraction chemistry, real-time pcr, and a liquid handling system to extract samples, confirm and quantify the presence of influenza, and reformat extracted samples for input into the sequencing system. serotype of human influenza samples will be performed by real-time pcr. many samples will not have enough material for further analysis and will need to be scaled up. the culturing system combines incubators, a liquid handling platform, plate reader, and real-time pcr to culture, monitor growth, harvest, and quantify influenza. when the system is not being used for culture and scale-up, it can be used to assay previously cultured influenza samples for drug resistance. a challenge to sequencing large numbers of influenza samples is the manpower required for sample preparation. the sequencing system has the capacity to prepare up to samples for sequencing per year for sanger sequencing. sanger sequencing was chosen because it is well-established for influenza surveillance, and automation-friendly. the system is designed to work with multiple primer sets ( , , ) . robotic systems all report to the lims. each process completion, plate movement, and data point are entered and checked by an online, web-based lims. status updates, notification, reporting, and data analysis can be achieved without entering the bsl containment facility. routine data analysis such as determining whether a cultured sample is ready to be harvested will be performed by the lims. complex data analysis, while still requiring significant human input, will be made easier by the data-acquisition functions of the lims. the implementation of a high-throughput influenza surveillance laboratory will provide an influenza research and response capacity that far exceeds what is available today. with the addition of each new system, we add a new capability to the influenza community and new opportunities to foster partnerships and collaborations with government, foundations, businesses, and academic institutions. this laboratory will not only enable cutting edge research, but will also enable a more effective response of near real-time surveillance during a pandemic outbreak. pandemics of and were believed to arise from avian influenza viruses. the tropism of avian and human seasonal influenza viruses for the human lower respiratory tract deserves investigation. the target cell types that support replication of avian influenza a viruses in the human respiratory tract in the early stages of clinical infection have not well defined. in a previous autopsy studies of human h n disease, influenza a virus were found to infect alveolar epithelial cells and macrophages. in this study, viral infectivity and replication competence of human and high and low pathogenic avian influenza viruses were systematically investigated in the human conducting and lower respiratory tract using ex vivo organ cultures. we compared the replication kinetics of human seasonal influenza viruses (h n and h n ), low pathogenic avian influenza viruses (h n , h n ) with that of the highly pathogenic h n viruses isolated from human h n disease. a range of human seasonal influenza a viruses of subtypes h n and h n viruses were included in this study from to . two isolates of low pathogenic avian influenza a (lpai) (h n ) viruses from different virus lineages isolated from poultry in hong kong in , a low pathogenic influenza a (h n ) virus isolate from wild ducks in hong kong in , and two virus isolates of highly pathogenic avian influenza (hpai) a subtype h n were included. fragments of human bronchi and lung were cut into multiple - mm fragments within hours of collection and infected in parallel with influenza a viruses at a titer of tcid ⁄ ml and as control cultures were infected with ultraviolet light inactivated virus. these tissues fragments were infected for hours and washed twice with pbs and incubated for , , and h at °c. the bronchial tissue was cultured in an air-liquid interface using sponge. viral yield was assessed by titration in mdck cells. one part of the infected tissue were fixed in formalin and processed for immunohistochemistry for influenza antigen. other part of infected tissue was homogenized and underwent rna extraction, and the expression of influenza virus matrix gene was measured by quantitative rt-pcr. human bronchus ex vivo cultures supported human seasonal influenza virus to replicate efficiently. avian influenza h n virus replicated, although less efficiently than that of seasonal influenza viruses, whereas hpai h n did not productively replicate in ex vivo cultures of human bronchus. this is in agreement with our previous finding in the well-differentiated bronchial epithelial cells in vitro. on the other hand, human lung ex vivo cultures supported prominent productive replication of human seasonal influenza h n ( figure a ) and hpai h n ( figure f ) viruses. lpai, such as h n ( figure c -d) and h n ( figure e ), also replicated productively, but with a lower viral yield. surprisingly, the replication of human influenza h n viruses ( figure b ) across the last three decades was greatly inhibited. there are clear differences in viral tropism of human seasonal and avian influenza viruses for replication in the human bronchus and lung. hpai h n virus can infect and productively replicate in the lower lung, which may account for the severity of human h n disease, but not in the conducting airways. surprisingly, there are marked differences in the replication competence of seasonal influenza viruses in ex vivo lung tissues, with influenza h n viruses being able to replicate efficiently while h n viruses do not. this may be related to the more strict siaa - gal binding preference of h n viruses. on the other hand, the efficient replication of influenza h n viruses in the alveolar spaces indicates factors other than tissues tropism alone play a role in the differences in disease severity between human seasonal h n and avian h n virus infections. pre-mrnas of the influenza a virus m and ns genes are poorly spliced in virus-infected cells. by contrast, in influenza c virus-infected cells, the predominant transcript from the m gene is spliced mrna. the present study was performed to investigate the mechanism by which influenza c virus m gene-specific mrna (m mrna) is readily spliced. ribonuclease protection assays showed that the splicing of m mrna in infected cells was much higher than that in m gene-transfected cells, suggesting that viral protein(s) other than m gene-translational products facilitates the splicing of viral mrnas. the unspliced and spliced mrnas of the influenza c virus ns gene encode two nonstructural (ns) proteins, ns (c ⁄ ns ) and ns (c ⁄ ns ), respectively. the introduction of translational premature termination into the ns gene, which blocked the synthesis of c ⁄ ns and c ⁄ ns proteins, drastically reduced the splicing of ns mrna, raising the possibility that c ⁄ ns or c ⁄ ns enhances the splicing of viral mrnas. the splicing of influenza c virus m mrna was increased by co-expression of c ⁄ ns , whereas it was reduced by co-expression of influenza a virus ns protein (a ⁄ ns ). the splicing of influenza a virus m mrna was also increased by co-expression of c ⁄ ns , whereas it was inhibited by that of a ⁄ ns . these results suggest that influenza c virus ns , but not a ⁄ ns , can up-regulate the splicing of viral mrnas. pre-mrnas of the influenza a virus m and ns genes are poorly spliced in virus-infected cells. , the inefficient splicing of viral pre-mrnas can be understood partly by the fact that influenza a virus ns protein is associated with spliceosomes and inhibits pre-mrna splicing. , cis-acting sequences in the ns transcript also negatively regulate splicing. by contrast, in influenza c virus-infected cells, the predominant transcript from the m gene is spliced mrna. the present study was performed to investigate the mechanism by which influenza c virus m gene-specific mrna (m mrna) is readily spliced. the yamagata ⁄ ⁄ strain of influenza c virus was grown in the amniotic cavity of -day-old embryonated hen's eggs. cos- and t cells were cultured in dulbecco's modified eagle's medium containing % fetal calf serum. subconfluent monolayers of cos- cells were transfected with pme s containing influenza c virus m gene cdna using the lipofectamine procedure and then incubated at °c. total rna was extracted from both the transfected cells and cells infected with c ⁄ yamagata ⁄ ⁄ virus using the rneasy mini kit (qiagen). ribonuclease protection assay was performed using a ribonuclease protection assay kit rpa iii (ambion). briefly, a [ p]-labeled influenza c virus rna -specific rna probe (vrna sense) was synthesized by in vitro transcription and hybridized with the total rna at °c overnight. hybrids were digested with rnase a ( ae u) and rnase t ( u) at °c for minutes and then analyzed on a % polyacrylamide gel containing m urea. hmv-ii cells infected with c ⁄ yamagata ⁄ ⁄ and cos- cells transfected with pme s expressing influenza c virus ns were fixed with carbon tetrachloride at various times after infection and transfection, respectively. the cells were then stained by an indirect method using anti-gst ⁄ ns serum as the primary antibody and fluorescein isothiocyanate-conjugated goat anti-rabbit igg (seikagaku kogyo) as the secondary antibody. the splicing efficiency of influenza c virus m gene-specific mrna (m mrna) in infected cells was higher than that in m gene-transfected cells the ratio of m encoded by a spliced m mrna to cm encoded by an unspliced m mrna in influenza c virusinfected cells was about times larger than that in m gene-transfected cells. ribonuclease protection assays showed that the splicing of m mrna in infected cells was much higher than that in m gene-transfected cells (figure ). these data suggest that viral protein(s) other than m gene-translational products facilitates viral mrna splicing. the influenza c virus ns gene translational product may up-regulate the splicing of viral mrnas the unspliced and spliced mrnas of the influenza c virus ns gene encode two nonstructural (ns) proteins, ns (c ⁄ ns ) and ns (c ⁄ ns ), respectively. the introduction of translational premature termination into the ns gene, which blocked the synthesis of c ⁄ ns and c ⁄ ns proteins, drastically reduced the splicing of ns mrna, suggesting that c ⁄ ns or c ⁄ ns enhances viral mrna splicing. immunofluorescent staining showed that ns localized in the nucleus in the early phase of infection, and was distributed in both the nucleus and cytoplasm in the late phase of infection, raising the possibility that influenza c virus ns protein plays a role in viral mrna splicing that occurs in the nucleus. the splicing of influenza c virus m mrna was increased by co-expression of c ⁄ ns , whereas it was reduced by co-expression of influenza a virus ns protein (a ⁄ ns ) (figure a ). the splicing of influenza a virus m mrna was also increased by co-expression of c ⁄ ns , though it was inhibited by that of a ⁄ ns ( figure b ). these results suggest that influenza c virus ns , but not a ⁄ ns , can up-regulate the splicing of viral mrnas. in influenza a virus-infected cells, splicing is controlled so that the steady-state amount of spliced mrnas is only - % of that of unspliced mrnas. , the mechanisms by which influenza a virus ns pre-mrnas are poorly spliced have been investigated and the following confirmed. influenza a virus ns protein associates with spliceosomes and inhibits pre-mrna splicing. , two cis-acting sequences in the ns transcript (positions - in the intron and positions - in the ¢ exon region) inhibit splicing. by contrast, influenza c virus m gene-specific mrna (m mrna) is efficiently spliced in influenza c virus-infected cells. in this study, we examined the mechanism by which influenza c virus m mrna is efficiently spliced and the regulatory mechanism of the splicing of ns gene-specific mrna (ns mrna). the introduction of a translational pre-mature termination into the influenza c virus ns gene, thereby blocking the synthesis of influenza c virus ns (c ⁄ ns ) and ns (c ⁄ ns ) proteins, drastically reduced the splicing rate of ns mrna. we further examined whether c ⁄ ns potentially facilitates viral mrna splicing. the splicing rate of m mrna of influenza c virus was increased by co-expression with c ⁄ ns , whereas it was reduced by co-expression with influenza a virus ns protein (a ⁄ ns ) (figure a ). the splicing of influenza a virus m gene-specific mrna was also increased by co-expression with c ⁄ ns , though it was inhibited by co-expression with a ⁄ ns ( figure b ). these results suggest that influenza c virus ns can facilitate viral mrna splicing, but in no way inhibit it, which is in striking contrast to the inhibitory effect of influenza a virus ns on pre-mrna splicing. , the mechanism for splicing enhancement by c ⁄ ns also remains to be determined. we speculate that c ⁄ ns may interact with some host proteins involved in splicing, thereby leading to an up-regulation in splicing, or that c ⁄ ns may bind to pre-mrna, increasing its accessibility to the spliceosome. the spliced mrna of the influenza c virus m gene encodes the m protein, which plays an important role in virus formation and determines virion morphology. , therefore, it is speculated that the mechanism for efficient splicing of m mrna, which provides the m protein necessary for virus assembly in a redundant amount, has been maintained in the influenza c virus. by contrast, unspliced mrna from the influenza c virus m gene encodes the cm ion channel, which is permeable to chloride ions, and also has ph-modulating activity. although the role of the influenza c virus cm ion channel in virus replication remains to be determined, it is conceivable that the over-expression of the cm protein has a deleterious effect on virus replication since the fact that a high level of influenza a virus m protein expression inhibits the rate of intracellular transport of the influenza a virus ha protein and other integral membrane glycoproteins has been demonstrated. if this is the case, efficient splicing of m mrna may control the amount of cm synthesized to optimize virus replication. therefore, we speculate that efficient splicing of m mrna leads to a high level of m expression and the reduced expression of cm , thereby creating conditions that are optimal for virus replication. in this study, we provided evidence that c ⁄ ns facilitates the splicing of m mrna. furthermore, c ⁄ ns may regulate the splicing efficiency of its own ns mrna during infection, controlling the amount of c ⁄ ns and c ⁄ ns proteins in infected cells. c ⁄ ns plays an important role in the nuclear export of vrnp, and is also associated with vrnp in the later stages of infection in virus-infected cells and is incorporated into virions, suggesting that c ⁄ ns is involved, not only in the sorting of vrnp into the assembly site, but also in virus assembly. therefore, it is likely that there is a mechanism by which an appropriate amount of c ⁄ ns is provided during infection to accomplish these functions. in conclusion, c ⁄ ns , which enhances the splicing of viral mrna, may regulate both the expression level of m gene-derived m and cm proteins, and that of ns gene-derived ns and ns proteins, thereby leading to optimal virus replication. propagation of the human influenza viruses in embryonated hen's eggs always results in a selection of variants with amino acid substitutions in the hemagglutinin (ha) that affect viral receptor-binding characteristics (reviewed ). brookes et al. recently studied infection in pigs using the egg-grown virus that contained a mixture of the original a ⁄ california ⁄ ⁄ (h n pdm) and its two egg-adaptation mutants with single amino acid substitutions d g and q r ( and in h numbering system). only the original virus and the variant with g were detected in the directly inoculated animals, indicating that the variant with r failed to infect. only the original virus was detected in nasal secretions of contact infected pigs, suggesting that the d g mutant failed to transmit. in contrast, there was an apparent selection of the d g mutant in the lower respiratory tract samples from directly inoculated pigs. the d g substitution is of a special interest as it can emerge during virus replication in humans and was associated with severe and fatal cases of pandemic influenza in - - and . here we compared phenotypic properties of the original clinical isolate of h n pdm virus a ⁄ hamburg ⁄ ⁄ and its d g and d r mutants to explain observed effects of these mutations on virus replication in swine and to predict their potential effects on virus replication in humans. a ⁄ hamburg ⁄ ⁄ (ham) was isolated from clinical material by two passages in mdck cells. the virus was passaged twice in -day-old embryonated hen's eggs and plaqued in mdck cells. the plaques were amplified in mdck cells and the sequences of the viral ha were determined. the variants with single mutation d g and q r were aliquoted and designated ham-e and ham-e , respectively. the receptor-binding specificity of the viruses was assessed by assaying their binding to desialylated-resialylated peroxidase-labeled fetuin containing either a - -linked sialic acid ( - -fet) or a - -linked sialic acid ( - -fet). in brief, viruses adsorbed in the wells of -well eia micro plates were incubated with serial dilutions of - -fet or - -fet, and the amount of bound fetuin probe was quantified by peroxidase activity. the binding data were converted to scatchard plots (a ⁄ c versus a ), and the association constants of the virus-fetuin complexes were determined from the slopes of these plots. viral cell tropism and replication efficiency in human airway epithelium were studied using fully differentiated cultures of human tracheo-bronchial epithelial cells (htbe). , to determine cell tropism, cultures were infected at a moi , fixed hours after infection, and double immuno-stained for virus antigen and cilia of ciliated cells. infected cells were counted under the microscope ( · objective with oil immersion) in the epithelial segment that included - consecutive microscopic fields containing between % and % ciliated cells relative to the total number of superficial cells. percentages of infected ciliated cells and infected non-ciliated cells relative to the total number of infected cells were calculated. ten segments per culture were analyzed and the results were averaged. to compare growth kinetics of ham and ham-e, replicate htbe cultures were infected with plaque-forming units of the viruses followed by incubation at °c under airliquid interface conditions. at , , and hours postinfection, we added dmem to the apical compartments of the cultures and incubated for minutes at °c. the apical washes were harvested, stored at ) °c, and analyzed simultaneously for the presence of infectious virus by titration in mdck cells as described previously. the non-egg-adapted h n pdm virus ham, similarly to the seasonal human virus a ⁄ memphis ⁄ ⁄ (h n ), bound to - -fet ( figure a ) and did not show any significant binding to - -fet. this result contrasted with the binding of h n pdm viruses to several - -specific probes in carbohydrate microarray analysis. reduced avidity of virus interactions with soluble glycoprotein in solution as compared to its binding to the probe clustered on the microarray surface could account for these differences in the assay results. the d g mutant ham-e differed from the parent virus by its ability to bind to -fet and by its reduced binding to -fet. the q r mutant only bound to - -fet, although less strongly than did the avian virus a ⁄ duck ⁄ alberta ⁄ ⁄ (h n ). the viral cell tropism in htbe cultures ( figure b ) correlated with receptor specificity. ham and mem ⁄ showed a typical human-virus-like tropism , with preferential infection of non-ciliated cells (< % of infected cells were ciliated). the mutant with r and control duck virus displayed a typical avian-virus-like tropism (preferential infection of ciliated cells). the d g mutant displayed a cell tropism that was intermediate between those of human and avian viruses; in particular, this mutant infected significantly higher proportion of ciliated cells than ham and mem ⁄ . observed alteration of receptor specificity and cell tropism ( figure ) suggested that egg-derived mutations can affect replication of the h n pdm virus in human airway epithelium. to test this, we first compared the capacity of the viruses to initiate infection in htbe cultures. replicate cultures were infected with identical doses of the viruses, fixed hours post-infection, and immuno-stained for viral antigen. under these conditions, ham and ham-e infected comparable numbers of cells, whereas ham-e infected at least times less cells (data not shown). this result indicated that the mutation q r markedly impaired the ability of ham-e to infect human airway epithelial cultures. we next compared two other viruses ham and ham-e for their multi-cycle replication in htbe cultures and found that the original virus reached threefold higher peak titers hours post infection than did the d g mutant ( figure ). the d g mutation in h n pdm virus facilitates virus binding to - -linked receptors and alters viral cell tropism in human airway epithelium. these changes could account for increased replication of the d g mutant in the lower respiratory tract in humans - and pigs and correlation of this mutation with severe pulmonary disease. [ ] [ ] [ ] [ ] [ ] the d g mutant replicates less efficiently in human airway cultures than the original virus. this finding correlates with an apparent lack of transmission of variants with g in humans and pigs. egg-derived mutation q r abolishes virus binding to - -linked receptors and strongly decreases infection in cultures of human airway epithelium. this result agrees with poor infectivity of the q r mutant in pigs and highlights potential pitfalls of using egg-adapted viruses with this mutation for the preparation of live influenza vaccines. nin-esterase-fusion (hef), nucleoprotein (np), matrix (m ) protein, cm , and the non-structural proteins ns and ns . , cm is the second membrane protein of the virus and is encoded by rna segment (m gene). [ ] [ ] [ ] [ ] [ ] [ ] it is composed of three distinct domains: a -residue n-terminal extracellular domain, a -residue transmembrane domain, and a -residue cytoplasmic domain. , , it is abundantly expressed at the plasma membranes of infected cells and is incorporated in a small amount into virions. , cm forms disulphide-linked dimers and tetramers, and is posttranslationally modified by n-glycosylation, palmitoylation, and phosphorylation. [ ] [ ] [ ] analyses of a number of cm mutants revealed the positions of the amino acids involved in the posttranslational modifications. , evidence was obtained that the n-glycosylation was not required for either the formation of disulfide-linked multimers or transport to the cell surface, and that none of dimer-or tetramer-formation, palmitoylation or phosphorylation was essential to the transport of cm to the cell surface. in the present study, in order to investigate the effect of cm palmitoylation on influenza c virus replication, we generated a cm palmitoylation-deficient influenza c virus, in which a cysteine at residue of cm was mutated to alanine, and examined the viral growth and viral protein synthesis in infected cells. t and hmv-ii cells were maintained as described previously. , llc-mk cells were maintained at °c in minimal essential medium with % foetal bovine serum and % calf serum. monoclonal antibodies (mabs) against the hef, np, and m proteins of c ⁄ ann arbor ⁄ ⁄ (aa ⁄ ), and antisera against the aa ⁄ virion and the cm protein were prepared as described previously. , [ ] [ ] [ ] the seven pol i plasmids for the expression of viral rnas of aa ⁄ , and the nine plasmid dnas for the expression of the influenza c viral proteins were reported previously. , plasmid dna, ppoli ⁄ cm -acy(-), in which -tgt- of the m gene was replaced with -gct- , was constructed based on ppoli ⁄ m. to generate a recombinant wild-type (rwt) virus, the above-mentioned plasmids were transfected into t cells as described previously. to rescue a mutant virus, rcm -c a, a recombinant influenza c virus lacking a cm palmitoylation site, the plasmid ppoli ⁄ cm -acy(-), instead of ppoli ⁄ m, was transfected together with the other plas-mids. at hours posttransfection (p.t.), the respective culture medium of the transfected- t cells was inoculated into the amniotic cavity of -day-old embryonated chicken eggs, and a stock of the recombinant virus was prepared. the infectious titres of the stocked recombinant viruses and the supernatants of recombinant-infected hmv-ii cells were determined according to the procedure reported previously. radioimmunoprecipitation hmv-ii cells infected with recombinants were labeled with [ s]methionine or [ h]palmitic acid. cells were then disrupted and subjected to immunoprecipitation with the indicated antibodies. the immunoprecipitates obtained were then analysed by sds-page on ae % gels containing m urea, and processed for fluorography. flotation analysis was performed according to the procedure described previously. to examine whether the cm protein without palmitoylation is synthesized in rcm -c a-infected cells, hmv-ii cells infected with the recombinants were subjected to , and the lysates of the cells were immunoprecipitated with anti-cm serum and analysed by sds-page. as shown in figure , the cm protein was synthesized both in the rwt-and rcm -c a-infected cells, but no incorporation of [ h]palmitic acid into the cm proteins synthesized in the rcm -c ainfected cells was observed, indicating that cm in the rcm -c a-infected cells was not palmitoylated. the rwt or rcm -c a viruses were infected to hmv-ii cells at an m.o.i. of and incubated at °c for up to hours. the infectious titres (p.f.u. ⁄ ml) of rwt were approximately -to -fold higher than those of rcm -c a at - hours p.i. (data not shown), indicating that rwt grew more efficiently than did rcm -c a. thus palmitoylation of cm appears to have some effect on the generation of infectious virions in cultured cells. to investigate the reason(s) for the difference in growth kinetics between the two recombinants, we analysed viral proteins synthesized in the infected hmv-ii cells. pulsechase experiments of hmv-ii cells revealed no significant differences in the synthesis and maturation of the hef, np, m , and cm proteins between the rwt-and rcm -c a-infected cells (data not shown). the infected cells pulse-labeled and chased were respectively immunoprecipitated with anti-cm serum in the presence of mm iodoacetamide and analysed by sds-page in non-reducing condition. in both populations of infected cells, several bands corresponding to cm a-monomer, -dimer, and -tetramer, as well as cm b-dimer and -tetramer were detected (data not shown). these results demonstrate an absence of any significant differences between palmitoylation-deficient cm and authentic cm in terms of conformational maturation and transport in infected cells. membrane flotation analysis revealed that no significant differences in the kinetics of the hef, m , and cm proteins were observed between rwt-and rcm -c ainfected cells (data not shown). in contrast, a slight difference in np kinetics was observed. the pulse-labeled np proteins were recovered in the bottom fractions in both rwt-and rcm -c a-infected cells. in the chase experiment, the amount of membrane-associated np proteins in fractions and was % of the total np in the rwt-infected cells, which was higher than that ( %) in the rcm -c a-infected cells (data not shown). this finding may suggest that the affinity of the np protein, presumably representing the viral ribonucleoprotein (vrnp) complex, to the plasma membrane in the rcm -c ainfected cells is lower than that in rwt-infected cells, leading to the less efficient generation of infectious virions. since cm is structurally similar to m , an influenza a virus membrane protein known to be involved in infectious virus production, [ ] [ ] [ ] [ ] [ ] it is possible that the cytoplasmic tail of cm participates in the genome packaging through interaction with vrnp. in the present study, we showed that the affinity of np to the plasma membrane of rcm -c a-infected cells was slightly lower than that to the plasma membrane of rwt-infected cells. this observation may suggest that palmitoylation of cm is involved in the viral ribonucleoprotein (vrnp) incorporation, leading to efficient infectious virion generation. we hypothesize that palmitoylation contributes to proper regional structure formation in the cm cytoplasmic tail, which is competent to recruit vrnp efficiently into virions. alternatively, the cm cytoplasmic tail without palmitoylation is not likely to reach the proper conformation, resulting in reduced interaction with vrnp and less efficient generation of infectious progeny virions. the questions of if and how the m protein is involved in the interaction between the cm cytoplasmic tail and np remains to be clarified. we showed that cm synthesized in rcm -c ainfected cells was oligomerized and transported to the cell surface. this finding is consistent with the previous observation that palmitoylation is not required for the transport of cm to the cell surface in cm -expressing cos- cells. however, the use of reverse-genetics system has enabled us to conclude that the palmitoylation of cm is required for efficient infectious virus production. this suggests that the significance of the other posttranslational modifications of cm during virus replication can be clarified using recombinant viruses lacking the respective modification sites. sialic acid (sia) linked glycoproteins are the classical influenza receptors for influenza virus haemagglutinin to bind. the distribution of sia on cell surfaces is one of the determinants of host tropism, and understanding its expression on human cells and tissues is important for understanding influenza pathogenesis. previous research has shown the differences in apical versus basolateral infection and release of different influenza virus from polarized epithelial cells and correlated this with sialic acid distribution in the human respiratory tract. moreover, mass spectrometric analysis was recently employed to elucidate the glycans present in the tissue in a higher resolution in human lung. the objective of this study was to examine in detail the distribution of these sia-linked glycans at the cellular level by the use of confocal microscopy. human primary type i-like and type ii pneumocytes were isolated from human non-tumor lung tissue by tissue fragmentation, percoll density gradient centrifugation, and magnetic cell sorting. the cells were seeded on coverslips and maintained in small airway growth medium. when confluence was reached, cell monolayers were fixed with % paraformaldehyde. we used the plant lectins, sambucus nigra glutinin (sna) from roche which binds to siaa - gal, maackia amurensis agglutinin (maa)i and maaii from vector lab, which bind the siaa - gal linked glycans using vector red as fluorescent chromogen. the cells were counter-stained with dapi or with fitc-conjugated antibody against endoplasmic recticulum (protein disulfideisomerase, pdi). the cells were imaged with multi-photon excitation laser scanning microscopy using zeiss lsm. the optical cross-section pictures were reconstructed by zeiss lsm meta. we found that there was more binding of maai and ma-aii to type ii pneumocytes than type i-like pneumocytes and more overall binding of these lectins than binding of sna ( figure ). in keeping with results from other polarized cells there was more binding to the apical than basolateral aspect, thus, explaining the previously published data on apical versus basolateral infection. as sialic acid has been implicated in the targeting of proteins to the surface, the relative lack of sialic acid on the basolateral aspect can explain why there is little seasonal influenza virus dissemination to the systemic circulation in human infections. furthermore, though there was little binding of sna to the figure . primary human type i-like and type ii pneumocytes stained with lecins (red), pdi (green), and dapi (blue) and imaged captured with confocal microscope. apical or basolateral aspects of the pneumocytes, the experimental findings of infection by influenza h n virus that has a strict siaa - gal tropism suggests that there are siaa - gal glycans present, which are not readily bound by the lectin sna. the in vitro model of primary human type i-like and type ii pneumocytes system formed a polarized epithelium that has a similar lectin distribution to human alveoli in vivo which demonstrated that it is a physiologically relevant model to study the tropism and pathogenesis of influenza a virus. human disease caused by highly pathogenic avian influenza (hpai) h n virus is associated with fulminant viral pneumonia and mortality rates in excess of %. cytokine dysregulation is thought to contribute to its pathogenesis. , we previously found delayed onset of apoptosis in h n infected human macrophages and, therefore, a longer survival time of the target cells for prolonged virus replication and cytokine and chemokine secretion, which may contribute to the pathogenesis of h n disease in humans. as bronchial and alveolar epithelial cells are target cells of influenza virus because of their proximal physiological location and interaction with macrophages, we further investigated if the differential onset of apoptosis could be found in influenza h n and seasonal influenza h n infected human respiratory epithelia. we dissected the apoptotic pathways triggered by influenza virus infection. seasonal influenza h n virus (a ⁄ hk ⁄ ⁄ ), a low pathogenic avian influenza h n lineage isolated from poultry (a ⁄ quail ⁄ hk ⁄ g ⁄ ), and two virus isolates of hpai a subtype (a ⁄ hk ⁄ ⁄ and a ⁄ vn ⁄ ⁄ ) were included. primary human bronchial and alveolar epithelial cells were infected with influenza viruses at moi of and the cell monolayer was collected at , , and hours post infection for tunel assay, and supernatant were collected for ldh assay. fragments of human lung tissues were cut into multiple - mm fragments within hours of collection and infected with influenza a viruses at a titer of tcid ⁄ ml. these tissues fragments were infected for hours and incubated for hours at °c. one part of the infected tissue was fixed in formalin and processed for immunohistochemistry for influenza antigen, and the other part was homogenized and underwent rna extraction. apoptosis cdna superarray platform (sabioscience) was employed to conduct apoptosis pathway analysis. in bronchial epithelial cells, seasonal influenza h n virus induced a high percentage of apoptotic cells by tunel assay at , , and hours post infection with a peak of (figure ) . a similar observation of delayed onset of apoptosis was found in influenza h n and h n infected alveolar epithelial cells. besides, cdna array data of ex vivo infected human lung showed that both influenza h n and h n virus induced trail expression compared with mock-infected tissue (approximately folds) at hours post infection, but influenza h n virus infected lung induced significantly more trail ( folds compared to mock infected cells), albeit with a limited viral replication ( figure ). influenza h n virus infected lung also elicited more tnf-alpha and fasr transcription than either h n or h n . these observations can account for the greater apoptotic response in influenza h n virus infected lung. as little impact on the expression of intrinsic pathway components was observed, it seems that the apoptotic response to influenza virus infection in lung was mainly through the extrinsic pathways. no significant changes in the expression of anti-apoptotic protein gene was found, except for a moderate induction of birc by influenza h n virus, which may act to modulate the apoptotic response. the delayed onset of apoptosis by hpai h n and low pathogenic avian influenza h n virus infected respiratory epithelial cells may be a mechanism for the influenza viruses to have more prolonged replication within the human respiratory tract, and this may contribute to the pathogenesis of human disease. hemagglutination (ha) assay % crbc suspension was treated by mu a , -specific sialidase at °c for minutes. complete elimination of a , -receptor on sialidase-treated crbcs was confirmed by receptor staining and flow cytometry. ha assay of live viruses with % crbc or % sialidase-treated crbc were performed in bsl- facility. synthetic ¢sln-paa-biotin(pa ), ¢sln-paa-biotin(pa ), ¢sln-ln-paa-biotin(pa ) was provided by the scripps research institute (tsri). as described elsewhere with some modifications, generally, serial dilutions of sialyglycopolymers were coated in -well-flat-bottom polystryrene plates, and hau live virus ⁄ well were added. alternatively, the plates were precoated with lg ⁄ ml sialyglycopolymers, and then , , , , hau live virus ⁄ well influenza viruses were added. rabbit antisera against a ⁄ ah ⁄ ⁄ diluted in pbs containing % bsa was added into the wells. bound antibody was detected by use of hrp-conjugated anti-rabbit igg antibody and tetramethylbenzidine substrate solution. each sample was determined in duplicates and the absorbance read at nm. a total of h n virus strains were obtained from to . the name and passage history of influenza viruses used in the study are listed in table . as the same sequences of eight rna segments were detected in a ⁄ js ⁄ ⁄ and a ⁄ js ⁄ ⁄ , only a ⁄ js ⁄ ⁄ was tested here. three amantadine-resistant variants with m mutation of screening of receptor-binding preference by ha assay representative results from three sets of independent experiments are shown in table . complete ha with sialidasetreated crbcs, which were only with a , -receptors, was detected in human influenza virus (a ⁄ brisbane ⁄ ⁄ , h n ) and two human h n virus strains, a ⁄ gd ⁄ ⁄ and a ⁄ gx ⁄ ⁄ . high binding of a , oligosaccharides to h n viruses was detected ( figure a -c). and enhanced a , -binding preference was also detected in a ⁄ gd ⁄ ⁄ and a ⁄ gx ⁄ ⁄ . the a , -binding was dose dependent for sialyglycopolymers and virus titer. notably, as compared with a ⁄ gd ⁄ ⁄ of both short-and long-a , recognition, a ⁄ gx ⁄ ⁄ prefers to bind to long-a , six oligosaccharides at low viral titer ( figure b,c) . however, both of them showed strong affinity to short-and long-a , oligosaccharides at high viral loads ( figure d ). sialoside-, galactoside-, mannoside-and sulfo-os-binding are the four types of carbohydrate-binding properties of influenza virus. binding of influenza virus to the a , -or a , -linked sialylated glycans on cell surface is important for host range restriction, and the preference to a , of h n virus limited its efficient infection in human. here, dual receptor-binding preferences were detected in a ⁄ gd ⁄ ⁄ and a ⁄ gx ⁄ ⁄ , which are of clade ae ae . although there is no direct evidence supporting the occurrence of human-to-human transmission in these infection events or the association between viral virulence and receptor-binding switching, viral systemic disseminations are found in the both fatal cases (data not shown). furthermore, with the introduction of clade ae ae into the adjacent countries of china, the finding of h n virus with - binding in human should be of concern. though h n virus with human-type receptor-binding was isolated from one patient treated by oseltamivir and those viruses were with ha and ⁄ or na substitutions, whether the substitutions responsible for receptor specificity switching is pre-existed or selected in human host remains unknown. our finding that three mutant viruses bearing m mutations of a s, a t, and s n cloned from one isolate a ⁄ hb ⁄ ⁄ suggested it is likely that the resistant viruses emerged in the host environment. no variation was found in their ha and na sequence, and all of them show high affinity to a - -binding. our data suggest that the binding-specificity was not affected by the mutations on viral envelope protein m . with the adaptation from wild aquatic birds to domestic poultry or even in human host environment, influenza virus may possess broader carbohydrate-binding spectrum or topology conformation. , we demonstrated differential a , -binding property of two human h n viruses, a ⁄ gd ⁄ ⁄ and a ⁄ gx ⁄ ⁄ . though minor effect of short-a , -binding was detected in viruses a ⁄ gx ⁄ ⁄ at low virus titer, both were of high affinity to long-a , glycans, even at the low titer which are rich on apical side of human upper respiratory epithelia. notably, no evident binding preference switching was detected in the viruses isolated from the sporadic human infection cases at the early of in china (table ) . however, higher affinity to the long-a , glycans was observed in bj ⁄ ⁄ , gz ⁄ ⁄ , and xj ⁄ ⁄ (data not shown). the discrepancy from the findings obtained by sialidase-treated crbc maybe associated with a limited abundance of n-linked a - with long branches on crbc, as demonstrated in a recent study. therefore, glycan dose-dependent binding assay is valuable and should be applied in flu surveillance. the underlying cause of the tendency is unknown, and further research on receptor-binding specificity of h n viruses is required. influenza a viruses of migrating wild aquatic birds in north america towards improved influenza a virus surveillance in migrating birds european union council directive ⁄ ⁄ eec the neighbor-joining method: a new method for reconstructing phylogenetic trees confidence limits on phylogenies: an approach using the bootstrap prospects for inferring very large phylogenies by using the neighbor-joining method mega : molecular evolutionary genetics analysis (mega) software version . the influenza virus resource at the national center for biotechnology information characterization of low-pathogenic h subtype influenza viruses from eurasia: implications for the origin of highly pathogenic h n viruses h n virus outbreak in migratory waterfowl a ⁄ h and a ⁄ h influenza viruses: different lines of one precursor evolution and ecology of influenza a viruses evolutionary processes in influenza viruses: divergence, rapid evolution, and stasis antigenic and genetic conservation of h influenza virus in wild ducks biologic characterization of chicken-derived h n low pathogenic avian influenza viruses in chickens and ducks genetic and pathogenic characterization of h n avian influenza viruses isolated in taiwan between and experimental selection of virus derivatives with variations in virulence from a single low-pathogenicity h n avian influenza virus field isolate evolution and ecology of influenza a viruses is china an influenza epicenter genesis of 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antigenic and genetic characterization of h n swine influenza in china cocirculation of avian h n and contemporary ''human'' h n influenza a viruses in pigs in southeastern china: potential for genetic reassortment? h n influenza a viruses from poultry in asia have human virus-like receptor specificity characterization of h subtype influenza viruses from the ducks of southern china: a candidate for the next influenza pandemic in humans? bioedit: a user-friendly biological sequence alignment editor and analysis program for window ⁄ ⁄ nt genetic algorithm approaches for the phylogenetic analysis of large biological sequence datasets under the maximum likelihood criterion phylogenetic analysis using parsimony (and other methods) . beta a novel genotype h n influenza virus possessing human h n internal genomes has been circulating in poultry in eastern china since characterization of h n influenza viruses isolated from vaccinated flocks in an integrated broiler chicken operation in eastern china during a year period characterization of avian h n influenza viruses from united arab emirates phylogenetic analysis of influenza a viruses of h haemagglutinin subtype h n subtype influenza a viruses in poultry in pakistan are closely related to the h n viruses responsible for human infection in hong kong diversified reassortants h n avian influenza viruses in chicken flocks in northern and eastern china genotypic evolution and antigenic drift of h n influenza viruses in china from the nucleoprotein as a possible major factor in determining host specificity of influenza h n viruses pigs as the ''mixing vessel'' for the creation of new pandemic influenza a viruses origins and evolutionary genomics of the swine-origin h n influenza a epidemic pandemic (h n ) outbreak on pig farm reassortment of pandemic h n ⁄ influenza a virus in swine from where did the 'swine-origin' influenza a virus (h n ) emerge? substitution of lysine at position in pb protein does not change virulence of the 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circulating worldwide from oseltamivir-resistant influenza viruses a (h n ), norway, - influenza activity -united states and worldwide, - season emergence of resistance to oseltamivir among influenza a(h n ) viruses in europe oseltamivir-resistant influenza virus a (h n ), europe, - season widespread oseltamivir resistance in influenza a viruses (h n ), south africa and composition of the - influenza vaccine emergence of h y oseltamivir-resistant a(h n ) influenza viruses in japan during the - season pyrosequencing as a tool to detect molecular markers of resistance to neuraminidase inhibitors in seasonal influenza a viruses neuraminidase sequence analysis and susceptibilities of influenza virus clinical isolates to zanamivir and oseltamivir host cell selection of influenza neuraminidase variants: implications for drug resistance monitoring in a(h n ) viruses neuraminidase receptor binding variants of human influenza a(h n ) viruses due to substitution of aspartic acid in the catalytic site -role in virus attachment? neuraminidase inhibitor susceptibility testing in human influenza viruses: a laboratory surveillance perspective update: drug susceptibility of swine-origin influenza a (h n ) viruses comprehensive assessment of pandemic influenza a (h n ) virus drug susceptibility in vitro detection of molecular markers of drug resistance in pandemic influenza a (h n ) viruses by pyrosequencing pandemic (h n ) and oseltamivir resistance in hematology/oncology patients fluview: a weekly influenza surveillance report prepared by the influenza division development of a sensitive chemiluminescent neuraminidase assay for the determination of influenza virus susceptibility to zanamivir evaluation of neuraminidase enzyme assays using different substrates to measure susceptibility of influenza virus clinical isolates to neuraminidase inhibitors: report of the neuraminidase inhibitor susceptibility network surveillance for neuraminidase inhibitor resistance among human influenza 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for complex multipathogen interactions in acute respiratory infections performance comparison of res-plex ii and xtag rvp fast for detecting respiratory viruses clinical virology symposium communityacquired respiratory co-infection (carc) in critically ill patients infected with pandemic influenza a (h n ) virus infection bacterial co-infections in lung tissue specimens from fatal cases of pandemic influenza a (h n ) -united states a quantitative risk assessment of exposure to adventitious agents in a cell culture-derived subunit influenza vaccine john's hopkins bloomberg school of public health design of an automated laboratory for high-throughput influenza surveillance human influenza surveillance: the demand to expand influenza: an emerging disease avian-to-human transmission of the pb gene of influenza a viruses in the and pandemics proinflammatory cytokine responses induced by influenza a (h n ) viruses in primary human alveolar and bronchial epithelial cells induction of proinflammatory cytokines in human macrophages by influenza a (h n ) viruses: a mechanism for the unusual severity of human disease? influenza h n and h n virus replication and innate immune responses in bronchial epithelial cells are influenced by the state of differentiation mapping of the two overlapping genes for polypepetides ns and ns on rna segment of influenza virus genome sequences of mrnas derived from genome rna segment of influenza virus: collinear and interrupted mrnas code for overlapping proteins influenza virus ns protein inhibits pre-mrna splicing and blocks mrna nucleocytoplasmic transport the influenza virus ns protein: a novel inhibitor of pre-mrna splicing identification of cis-acting intron and exon regions in influenza virus ns mrna that inhibit splicing and cause the formation of aberrantly sedimenting presplicing complexes identification of a second protein encoded by influenza c virus rna segment influenza c virus ns protein upregulates the splicing of viral mrnas identification of an amino acid residue on influenza c virus m protein responsible for formation of the cord-like structures of the virus a mutation on influenza c virus m protein affects virion morphology by altering the membrane affinity of the protein detection of ion channel activity in xenopus laevis oocytes expressing influenza c virus cm protein evidence that the cm protein of influenza c virus can modify the ph of the exocytic pathway of transfected cells the ion channel activity of the influenza virus m protein affects transport through the golgi apparatus intracellular localization of influenza c virus ns protein (nep) in infected cells and its incorporation into virions receptor specificity, host range and pathogenicity of influenza viruses replication, pathogenesis and transmission of pandemic (h n ) virus in non-immune pigs world health organization. preliminary review of d g amino acid substitution in the haemagglutinin of pandemic influenza a (h n ) viruses 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specificity of pandemic influenza a (h n ) virus determined by carbohydrate microarray fields virology. philadelphia, pa: lippincott williams & wilkins the molecular virology and reverse genetics of influenza c virus identification of a second protein encoded by influenza c virus rna segment identification of a amino acid protein encoded by rna segment of influenza c virus influenza c virus cm protein is produced from a amino acid protein (p ) by signal peptidase cleavage a mutation on influenza c virus m protein affects virion morphology by altering the membrane affinity of the protein influenza c virus cm integral membrane glycoprotein is produced from a polypeptide precursor by cleavage of an internal signal sequence evidence that the matrix protein of influenza c virus is coded for by a spliced mrna functional properties of the virus ion channels the cm protein of influenza c virus is an oligomeric integral membrane glycoprotein structurally analogous to influenza a virus m and influenza b virus nb proteins characterization of a second protein (cm ) encoded by rna segment of influenza c virus phosphorylation of influenza c virus cm protein the sites for fatty acylation, phosphorylation and intermolecular disulphide bond formation of influenza c virus cm protein identification of an amino acid residue on influenza c virus m protein responsible for formation of the cord-like structures of the virus a human melanoma cell line highly susceptible to influenza c virus antigenic characterization of the nucleoprotein and matrix protein of influenza c virus with monoclonal antibodies construction of an antigenic map of the haemagglutinin-esterase protein of influenza c virus the synthesis of polypeptides in influenza c virus-infected cells new low-viscosity overlay medium for viral plaque assays the influenza virus m protein cytoplasmic tail interacts with the m protein and influences virus assembly at the site of virus budding the cytoplasmic tail of the influenza a virus m protein plays a role in viral assembly the influenza a virus m cytoplasmic tail is required for infectious virus production and efficient genome packaging distinct domains of the influenza a virus m protein cytoplasmic tail mediate binding to the m protein and facilitate infectious virus production influenza virus m ion channel protein is necessary for filamentous virion formation influenza h n virus infection of polarized human alveolar epithelial cells and lung microvascular endothelial cells das inhibits h n influenza virus infection of human lung tissues receptor binding specificity of recent human h n influenza viruses differential onset of apoptosis in avian influenza h n and seasonal h n virus infected human bronchial and alveolar epithelial cells: an in vitro and ex vivo study human influenza virus a ⁄ hongkong ⁄ ⁄ (h n ) infection induction of proinflammatory cytokines in human macrophages by influenza a (h n ) viruses: a mechanism for the unusual severity of human disease? proinflammatory cytokine responses induced by influenza a (h n ) viruses in primary human alveolar and bronchial epithelial cells differential onset of apoptosis in influenza a virus h n -and h n -infected human blood macrophages avian flu: influenza virus receptors in the human airway haemagglutinin mutations responsible for the binding of h n influenza a viruses to humantype receptors an avian influenza h n virus that binds to a human-type receptor evolution of highly pathogenic h n avian influenza viruses in vietnam between evolutionary dynamics and emergence of panzootic h n influenza viruses writing committee of the second world health organization consultation on clinical aspects of human infection with avian influenza a (h n ) virus recent avian h n viruses exhibit increased propensity for acquiring human receptor specificity a simple screening assay for receptor switching of avian influenza viruses glycan topology determines human adaptation of avian h n virus hemagglutinin h n chicken influenza viruses display a high binding affinity for neu acalpha - galbeta - ( -hso )glcnac-containing receptors a strain of human influenza a virus binds to extended but not short gangliosides as assayed by thin-layer chromatography overlay search for additional influenza virus to cell interactions avian flu: isolation of drug-resistant h n virus the surface glycoproteins of h influenza viruses isolated from humans, chickens, and wild aquatic birds have distinguishable properties this study was supported by the li ka shing foundation, the national institutes of health (niaid contract hhsn c), and the area of excellence scheme of the university grants committee (grant aoe ⁄ m- ⁄ ) of the hong kong sar government. this work was supported by the national institute of allergy and infectious diseases (niaid) contract hhsn c, the li ka shing foundation, and we thank all french and vietnamese field staff involved in the data collection in viet nam for their enthusiasm and support and we are grateful to the pig farmers participating in the study for their cooperation and patience. this study was a part of the gripavi project and was funded by the french ministry of foreign affairs. this research was supported in part by the national institute of allergy and infectious diseases (niaid) contract hhsn c and the area of excellence scheme of the university grants commission (grant aoe ⁄ m- ⁄ ) of the hong kong sar government. we acknowledge the food and environmental hygiene department of hong kong for facilitating the study. this work was supported by the national institute of allergy and infectious diseases (niaid) contract hhsn c, the li ka shing foundation, and the area of excellence scheme of the university grants committee (grant aoe ⁄ m- ⁄ ) of the hong kong sar government. we gratefully acknowledge our colleagues from iiii, shantou university and skleid, hku for their excellent technical assistance. the study was supported by the rfcid commissioned study (lab# ) from research fund secretariat, food and health bureau, hong kong sar; area of excellence scheme of the university grants committee (grant aoe ⁄ m- ⁄ ), hong kong sar; and by niaid contract (sjceirs, hhsn c), nih, usa.ferrets in all groups inoculated with a ⁄ turkey ⁄ ⁄ virus survived the infection and were observed once daily for days. below lower limit of detection (< ae log eid ⁄ ml).statistical cutoff of ic values for nai susceptibility, determined by x ae + iqr. outliers with ic above this cutoff and > times the mean ic for each drug were characterized as extreme outliers; those with known drug-resistance mutations such as h y were classified as resistant and analyzed separately. h wildtype, oseltamivir-susceptible isolates. h y variants, oseltamivir-resistant virus isolates. iqr, interquartile ranges; nai, neuraminidase inhibitors. we wish to thank our collaborators in the who global influenza surveillance network and united states public health laboratories for the submission of virus isolates and clinical specimens. we also thank our colleagues from the virus reference team and the influenza sequence activity, influenza division, cdc, for their valuable technical assis-the findings and conclusions of this report are those of the authors and do not necessarily represent the views of the centers for disease control and prevention (cdc). we are indebted to yonas araya, theresa wolter, and ivan gomez-osorio for their excellent laboratory techniques and animal handling assistance. we would like to thank andrea ferrero for her laboratory managerial skills. this research was possible through funding by the cdc-hhs grant ( u ci ), niaid-nih grant, (r ai ), csrees-usda grant ( - ), and niaid-nih contract (hhsn c). we thank c bazzoli for advice. this work was supported by a grant from the european union fp project flu-modcont (no. ). we thank staff at seoul, incheon, daejeon, gwangju, gangwon, and jeonbuk provincial research institute of health and environments for their laboratory testing. additionally, we would like to acknowledge the contributions of participating sentinel doctors for evaluating the new rat kit. this study was supported by a grant from the korea cdc. we thank roche applied science for providing the materials and equipment for this evaluation. this research was supported in part by the national institute of allergy and infectious diseases (niaid) contract hhsn c and the area of excellence scheme of the university grants committee (grant aoe ⁄ m- ⁄ ) of the hong kong sar government. the authors would like express their sincere thanks to cdc, usa for supporting the routine surveillance of ili in we would like to acknowledge the australian red cross blood service (the blood service) and the australian government, which fully fund the blood service for the provision of blood products and services to the australian community. we also wish to thank the donors and staff of the blood service, who have assisted in provision of specimens for testing in this protocol, as well as the staff at the who we are grateful to liping long for her assistance in map generation. this project was supported by nih niaid rc ai . cz is supported partially by canadian nserc postdoc fellowship. the authors thank the national investigation team based at the national institute of health (istituto superiore di sanita'), italy (in particular antonino bella, maria cristina rota, stefania salmaso) for providing their support in data collection, and the european union this study was supported in part by a grant-in-aid ( ) and the special coordination funds for promoting science and technology of ministry of education, science, sports and culture of japan. this study was supported in part by a grant-in-aid from the ministry of education, science, and culture of japan ( ) and the special coordination funds for promoting science and technology of mext of japan. the work described here was supported by phs grant ai- (jam) and alsac. we thank all authors for their participation in data gathering and analysis, and in writing this manuscript. the studies were funded by gsk consumer healthcare, and gsk investigators were involved in all stages of the study conduct and analysis. py, po, dw and kb are employees of glaxosmithkline. this study was funded by glaxosmithkline. we thank all authors for their participation in data gathering and analysis, and in writing this manuscript. the studies were funded by gsk consumer healthcare, and gsk investigators were involved in all stages of the study conduct and analysis. this study was funded by glaxosmithkline. we thank all authors for their participation in data gathering and analysis, and in writing this manuscript. the stud- authors are thankful to path for the financial support of this research. we would like to acknowledge jessica d'amico and dr. rick bright of path for their editorial review. this study was supported by path. the authors would like to thank rick bright, jessica d'amico, and vadim tsvetnitsky for editing assistance. the we thank dr. m. enami (kanazawa university) for generously providing plasmids containing cdnas to influenza a virus m and ns genes. we also gratefully thank dr. r. sho (department of public health, yamagata university faculty of medicine) for statistical analysis. some data shown in this study have also been presented in the reference paper. this work was supported in part by a grant-in-aid for scientific research from the ministry of education, culture, sports, science, and technology, japan, takeda science foundation, terumo life science foundation, and a grant-in-aid from the global coe program of the japan society for the promotion of science. we thank markus eickmann for his help in isolation and initial characterization of a ⁄ hamburg ⁄ ⁄ and for providing antisera against h n pdm. this study was supported by the european union fp global a(h n ) genetic characterization, molecular evolution dynamics, antiviral susceptibility profiles, and inference of public health implications require nation and region wide systematic analysis of circulating virus. in this study we analysed the genetic and antiviral drug susceptibility profiles of pandemic a(h n ) influenza virus circulating in portugal. genetic profile analysis was performed in isolates to the hemagglutinin (ha), neuraminidase (na) and mp genes, and in six of these isolates the pb , pb , pa, np and ns genes were also analysed. antiviral drug susceptibility profile was analysed for isolates, phenotypically and genotypically to neuraminidase inhibitors (nai) and genotypically to amantadine. the point mutations identified in ha, na, and mp genes of different strains do not seem to evidence an evolutionary trend. this is in agreement with the genetic and antigenic homogeneity that has being described for a(h n ) virus. all analysed strains were found to be resistant to amantadine, and five of these strains exhibited a reduced susceptibility profile to nai, three only for oseltamivir and two for both inhibitors. introduction: the dynamics of pandemic influenza a ⁄ h n compared to seasonal strains of influenza is not clearly understood. it is important to understand the patterns of viral shedding and symptoms over time in community-based infections.materials and methods: household infections were followed-up in two large community-based studies. patterns of viral shedding, symptoms and signs, and tympanic temperature were plotted over time and grouped according to strain for analysis.results: the patterns of viral shedding, symptoms and signs, and tympanic temperature in three influenza a strains (pandemic a ⁄ h n , seasonal a ⁄ h n , and seasonal a ⁄ h n ) were comparable. peak viral shedding occurred close to the onset of symptoms and resolved after - days. patterns of viral shedding in influenza b virus infections differed.discussion: the patterns of viral shedding and clinical course of pandemic influenza a ⁄ h n infections were broadly similar to seasonal influenza a ⁄ h n and a ⁄ h n . only the clinical course of seasonal influenza b infections was similar to pandemic influenza a ⁄ h n . the dynamics of pandemic influenza a ⁄ h n were observed to be largely alike to the dynamics of seasonal influenza a ⁄ h n and a ⁄ h n . the coated respirators inactivated a broad range of influenza strains within minute, including the pandemic strain and human, swine, and avian influenza viruses. antiviral effectiveness was not reduced by hot, humid conditions or repeated saturation, which might occur during prolonged use of respirators. in contrast, infectious virions were detected on the surfaces of all uncoated ffp respirators, and could be transferred to glove surfaces during handling of contaminated masks. growth of the viruses was monitored by ha titer using turkey red blood cells, by quantitative real time rt-pcr (qrt-pcr) to detect the influenza a matrix gene, and also by flow cytometry to detect virus positive cells using monoclonal antibodies (imagen influenza virus a and b). , matrix gene copy number was determined using qrt-pcr and analysed using the sequence detection software on a fast system sds (applied biosystems, california, usa). further characterisation was performed through sequence analysis and the ha inhibition (hai) assay. sequence analysis was performed using dnastar and all sequences obtained were compared with the sequence of either the original clinical specimen if available or the conventional atcc derived mdck cell isolate. the hai assay was used to characterize the viruses against a panel of known standard reference viruses and their homologous ferret antiserum.options for the control of influenza vii abstract background: we measured the cross-reactive antibody response to pandemic h n in children and adults before and after vaccination with [ ] [ ] [ ] [ ] influenza season vaccines as part of the rapid public health response to the emergence of ph n and to provide evidence for ph n vaccination policy development in mainland china. materials and methods: archived serum specimens from previous vaccine studies were detected by hemagglutination inhibition assay. results: limited crossreactive antibody response to ph n had been detected among participants of all age groups before and after they had been vaccinated with - , - influenza seasonal vaccines. vaccination with seasonal influenza viruses resulted in limited seroconversion to ph n in all age groups, compared with - % of seroconversion to seasonal influenza viruses. but similar to recent studies, a peak of cross-reactive antibody response to ph n was observed in % and % of participants born from to before and after vaccination. conclusions: in order to protect our populations in china, our study strongly suggests vaccination with ph n is required in all age groups and that older populations born before may be associated with a lower infection rate of ph n . on april and april , , cases of ph n were identified in specimens obtained from two epidemiologically unlinked patients in the united states and soon thereafter in texas and mexico. since that time, the virus has spread across the globe. assessment of cross-reactive antibody response to the ph n after vaccination with sea-sonal influenza vaccine was first reported from us centers of disease control and prevention (us cdc). according to their results, the seasonal influenza vaccines provided little or no protection against the ph n , but some degree of preexisting immunity to the virus existed, especially among adults aged ‡ years. in this study, using archived serum samples from previous vaccine studies, we measure the level of cross-reactive antibody response to ph n in children and adults vaccinated intramuscularly with trivalent inactivated vaccine developed for the northern hemi- serum specimens were collected and provided by provincial centers for disease control and prevention of china as a public health response to the emergence of ph n exempt from human-subjects review. a total of serum samples were collected from xinjiang uygur autonomous region, yunnan, and shandong provinces. all the serum specimens were grouped by the age of subjects ( - , - , - , ‡ years) and by different influenza seasons.hemagglutination inhibition assay was performed according to standard procedures in this study. [ ] [ ] [ ] as with h n components of the vaccine, the seasonal influenza viruses used in this study were a ⁄ solomon islands ⁄ ⁄ and a ⁄ brisbane ⁄ ⁄ . the ph n influenza virus used in this study was a ⁄ california ⁄ ⁄ provided by us cdc. all the viruses were propagated in specific pathogenfree embryonated chicken eggs and inactivated by & paraformaldehyde. the criteria recommended by the european agency for the evaluation of medical product was applied for the assessment of seasonal influenza vaccine gmt, geometric mean titer; hi, hemagglutination inhibition. three weeks after boosting immunization, spleens were harvested from immunized and control mice. splenocytes were prepared by lymphocyte separation media (ez-sepÔ, shen zhen, china). the cells were washed and resuspended in complete rpmi- containing fetal bovine serum (hyclone, logan, ut, usa), glutamax, um b-me. splenocytes were cultured in vitro in the presence of inactivated h n , h n , h n , and h n influenza virus antigen for h. quick cell proliferation assay kit (biovision, san francisco, ca, usa) was used to detect the cell proliferation. the - nm absorbance was read on a plate reader. all experiments have been repeated at least three times.results are presented as mean standard error of the mean (sem). comparison of the data was performed using the student's t-test. significance was defined as a p value of < ae . to evaluate the adjuvant effect of recombinant igv, the anti m e antibody subclasses was measured. igg and igg a were detected after the first and second immunization ( table ). the ratio of igg a ⁄ igg was calculated. immunization with only m e-hbc showed a lower igg a ⁄ igg ratio < ae . igv combined with m e-hbc led to a high igg a ⁄ igg ratio of up to - after first and second immunization. these igg subclass distributions indicated that igv can induce a th immune response. to determine whether the splenocytes were stimulated in vitro with different subtypes of inactivated influenza antigen after the igv plus m e-hbc antigen immunization, h n , h n , h n , h n inactivated antigen was used table . the serum igg, igg , igg a, and igg a ⁄ igg ratio were measured by elisa after first and second immunization. m e were coated on the wells plate overnight, and serial dilution sera of day , , after first and second immunization were added , ae , , , , ug ⁄ ml of igg, igg , igg a purified antibody were also added for obtaining the standard curve. hrp-labeled goat anti-mouse igg, igg , or igg a was then added, washed, and the optical density was read at nm. the results were showed at mean ± sem. day after first immunization days after second immunizationoptions for the control of influenza vii the french grog (groupes régionaux d'observation de la grippe) early warning network collects more than specimens yearly from cases of acute respiratory illness (ari), using two sampling methods: systematic randomized and non systematic ''ad hoc'' sampling. although vaccines against influenza a virus are the most effective method by which to combat infection, it is clear that their production needs to be accelerated and their efficacy improved. a panel of recombinant live attenuated human influenza a vaccines (laivs), including ns - , ns - , nsd , were generated by rationally engineering mutations directly into the genome of a pandemic-h n virus. the vaccine potential of each laiv was determined through analysis of attenuation, immunogenicity, and their ability to protect mice and ferrets. the data indicate that the novel nsd -laiv was ideally attenuated and elicited strong protective immunity. this study also shows that attenuating mutations can be rapidly engineered into the genomes of emerging ⁄ circulating influenza a viruses in order to produce laivs. the influenza virus exhibits complicated evolutionary dynamics due to multiple reasons, such as diverse hosts, high mutation rates, and rapid replications. in this study, large-scale analyses of influenza neuraminidase (na) sequences revealed influenza a and b na genes diverged first around years ago, and subsequently the na subtypes of influenza a emerged around years ago. all nine na subtypes of influenza a were genetically distinct from each other, with a total of lineages identified. in addition, five and three sub-lineages were further identified in lineage a of na and lineage b of na , respectively. the majority of lineages and sub-lineages were found to be host or geographic specific. this study provides not only a better understanding of influenza na evolution, but also a database of lineages and sub-lineages that can be used for early detection of novel genetic changes for improved influenza surveillance. although phylogenetic approaches are commonly used and often found to be powerful, how to accurately identify lineages or sub-lineages of a gene segment of the influenza a virus remains a challenging issue. in this study, we address this issue by analyzing hemagglutinin (ha) sequences using a combination of statistical and phylogenetic methods. following a hierarchical nomenclature system that uses a letter to represent a lineage and a digit for a sub-lineage, we identified distinct lineages and sub-lineages in all ha subtypes through large-scale analyses of influenza a hemagglutinin sequences. the majority of the lineages or sub-lineages were host or geographic specific or both. further analysis of other segments will allow us to construct a comprehensive database for influenza a lineages and genotypes, facilitating early detection of new viral strains and genome reassortments and hence improve influenza surveillance. identification of the genetic origin of influenza a viruses will facilitate understanding of the genomic dynamics, evolutionary pathway, and viral fitness of influenza a viruses. the exponential increases of influenza sequences have expanded the coverage of influenza genetic pool, thus potentially reducing the biases for influenza progenitor identification. however, these large amounts of data generate a great challenge in progenitor identification. clinical (nasopharyngeal swabs) and post-mortem materials (fragments of trachea, bronchi, lungs, spleen) were obtained from clinics and ⁄ or out-patients from st. petersburg and from base virological laboratories (bvls) of the research institute of influenza in different regions of the country, which cover approximately ⁄ of the territory of russia. the informed consent for the bio-materials collection and studies was obtained from research subjects or from their relatives in cases of post-mortem materials. isolation of viruses was carried out in the mdck cell culture (cdc, atlanta, ga, usa) and in -day-old chicken embryos (e). isolation was done according the standard internationally accepted methods. the reaction of hemagglutination (ha) and the inhibition of hemagglutination (hai) were performed according the who recommended standard method. for the identification of epidemic isolates, we used the hyperimmune diagnostic bovine or ovine antisera annually obtained from the who reference center (cdc). for a detailed antigenic analysis we used the hyperimmune rat antisera against epidemic and reference influenza strains during the period from july , up to april , , we have obtained swabs from clinics and out-patients in st. petersburg and swabs from the bvls. in this period, rather high incidence of lethality from pneumonia was observed, which developed on the background of the pandemic flu h n v. thus, we received from bvls postmortem materials from deceased patients which manifested pcr+ influenza h n v-specific rna. all materials were tested for a possibility of isolation of influenza virus h n v both in eggs and in mdck cells. pcr-negative materials were discarded. we isolated strains of pandemic influenza from the materials collected in st. petersburg and region, which comprised ae % of the total number of analyzed samples. at the same time, we did not isolate any other sub-types of influenza in the season - except the pandemic flu. from the swabs purchased from bvls, strains were isolated, which compose ae % of the pcr+ samples, and strains from the post-mortem materials ( ae % of the pcr+ samples).altogether in the season - , we isolated, retrieved, and analyzed in hai influenza strains. ae % of them were pandemic strains a(h n )v, and only ae % influenza b viruses. these data together with the epidemiologic data and the results of pcr-diagnostic provide evidence in favor of nearly mono-etiological character of epidemic season - in russia for pandemic influenza a(h n )v.though the isolation of pandemic viruses was fulfilled in two traditional model systems, in the case of pandemic virus, we could observe the tendency of preferential multiplication in embryos compared to mdck, especially in cases of post-mortem material for which chicken embryos are the preferential system of isolation.h n v viruses, which were isolated and passaged in mdck, even with significant ha titers, quickly lost their ha activity provided they were kept at + °c. moreover, some other tested cell lines proved to be practically nonsensitive to the pandemic viruses h n v. we used hai reaction for the typing and antigenic characterization of isolated viruses. in the course of isolation of viruses in the reported period, we produced rat polyclonal antisera to the strains a ⁄ california ⁄ ⁄ and a ⁄ st. petersburg ⁄ ⁄ (h n )v and the antisera to the strains a ⁄ new jersey ⁄ ⁄ -the virus isolated during the epidemic in the united states and also of the swine origin -and to the 'swine' strains a ⁄ sw ⁄ ⁄ and a ⁄ iowa ⁄ ⁄ . the hai results of representative strains are given in figure . table shows that the isolated strains were homogenous in their antigenic properties and interacted with the diagnostic antiserum cdc for a(h n )v and also with the antisera to the strains a ⁄ california ⁄ ⁄ and a ⁄ st. petersburg ⁄ ⁄ up to - ⁄ homologous titer. viruses that were isolated from post-mortem materials did not differ by their antigenic characteristics from those isolated from swabs of live patients. only two strains could be attributed to the drift-variants of the strain a ⁄ california ⁄ ⁄ because they reacted with the appropriate antiserum up to ⁄ homologous titer; these strains were a ⁄ pskov ⁄ ⁄ and a ⁄ belgorod ⁄ ⁄ . it is interesting that the isolated strains reacted with the antisera to the strains a ⁄ new jersey ⁄ ⁄ and a ⁄ sw ⁄ ⁄ to ⁄ - ⁄ , and some particular strains even to ⁄ homologous titer. it is even more interesting that some pandemic isolates reacted with the antiserum to the strain iowa isolated in up to ⁄ - ⁄ homologous titer. despite of the fact that since the outbreak of 'swine flu' in the usa in new jersey years had gone (and for the strain iowa this period is nearly years) the ha of these viruses and of the pandemic influenza share some common antigenic determinants as was shown in hai.one more interesting feature of a considerable part of isolated strains is their capability to react with high titers with normal equine serum heated to and to °c, while all the strains of swine origin isolated earlier were inhibitor-resistant ( figure ). russian isolates of divided, in this respect, in two clear and approximately equal in number groups: one of them is similar to the reference strain amino acid substitutions, among them more than were disclosed in antigenic sites, so the degree of similarity to this strain is %. a new site of glycosylation was also discovered in the position of ha. essential distinctions of the aminoacid sequence of ha and antigenic properties of the h n v strains as compared with actual circulating and vaccine strains is one of the factors that determine the pandemic potential of this new influenza virus.according to the literature, the mutation in the ha gene d g could cause a broadening of the spectrum of receptor specificity of influenza virus by the acquisition of the capacity to bind both the residues a( fi ) and a( fi ) of the sialic acid of cellular receptors. both types of receptors are present at the human respiratory tract, but in different parts of it, and they exist in different proportions. according to the data of the european center of disease control and prevention (ecdc), the varieties g of the h n v virus were isolated in countries from subjects deceased of influenza or who suffered a severe form of illness, as well as from those who sustained only a light course of influenza. concerning the strains isolated in rii, this mutation was discovered in nine cases: four were isolated from live patients and five from post-mortem materials. thus, there are no convincing data at present that could prove a causal relationship of the given substitution and the aggravation of a disease course. this is in accordance with previous observations. concerning the resistance of studied strains to the widely used antiviral preparations, it was shown that all tested strains possessed the substitution s n in the m protein that determine the resistance to adamantanes. there was no substitution in the position of neuraminidase (na), which determines the resistance to oseltamivir (h y). these substitutions are the characteristic indices of the eurasian lineage of swine influenza viruses. thus all studied russian h n v isolates were resistant to adamantanes (rimantadine) and sensitive to oseltamivir. respiratory clinical samples taken in and that tested positive by real time reverse transcription (rt)-pcr for seasonal influenza viruses (a and b) and pandemic h n respectively were assessed for other respiratory viruses using the resplex ii panel ver . system distributed by qiagen. results showed that co-infections with another respiratory viruses were relatively rare, with a small number of samples having another co-infecting virus present, very few samples having two other viruses detectable in their samples, and none with further viruses. this low number of co-infecting viruses and the ability of certain cell lines not to support infection with particular viruses may make primary isolation of influenza viruses in cell lines easier than might have been thought previously. cm is the second membrane protein of influenza c virus and is posttranslationally modified by phosphorylation, palmitoylation, n-glycosylation, and dimer ⁄ tetramer formation. in the present study, we generated rcm -c a, a recombinant influenza c virus lacking cm palmitoylation site, and examined viral growth and viral protein synthesis in the recombinant-infected cells. the rcm -c a virus grew less efficiently than did the wild-type virus. membrane flotation analysis of the infected cells revealed that less np was recovered in the plasma membrane fractions of the rcm -c a-infected cells than that in the wild-type virus-infected cells, suggesting that palmitoylation of cm is involved in the affinity of the ribonucleoprotein complex to the plasma membrane, leading to the efficient generation of infectious viruses. influenza c virus has seven single-stranded rna segments of negative polarity, encoding pb , pb , p , haemaggluti- both the a , linkage and its topology on target cells were critical for human adaptation of influenza a viruses. the binding preference of avian flu virus h n ha to the a , -linked sialylated glycans is considered the major factor that limited its efficient infection in human. currently, the switch in binding-specificity of human h n viruses from a , to a , -glycans did naturally occur, and limited humanto-human transmission was found. to monitor their potential adaptation in the human population, receptor-binding specificity surveillance was made in china. here, the binding specificity of human h n virus strains isolated from to was demonstrated. dual binding preference to a , and a , -glycans were found in a ⁄ guangdong ⁄ ⁄ and a ⁄ guangxi ⁄ ⁄ . furthermore, both of them showed a high affinity to the long-branched a , -glycans, which predominate on the upper respiratory epithelial in human. our data suggests that the existence of h n virus with binding specificity to humans should be of concern.introduction via envelope glycoprotein hemagglutinin (ha), influenza viruses bind to cell-surface glycosylated oligosaccharides terminated by sialic acids (sa) where their linkage is celland species-specific. differential receptor binding preference is a host barrier for influenza virus transmission. although most h n viruses have low affinity to neu aca , gal (human-type) receptor, recent findings suggested that the adaptation of h n virus to human by mutations in the receptor-binding site (rbs) do indeed happen and resulted in enhanced affinity to human-type receptor. [ ] [ ] [ ] in contrast to its putative precursor, a ⁄ gs ⁄ gd ⁄ ⁄ , diverse genotypes were presented in currently circulating h n virus, accelerating evolution and widespread occurrence. , to date, distinct phylogenetic clades ( - ) were identified based on h n ha, and the confirmed human infections were caused by clade , , ae , ae , ae , and . in china, human h n disease was mostly caused by clade ae ae , which was identified in isolates from confirmed patients from provinces since . clade and clade ae are responsible for the case in and , respectively. two current cases of and were due to clade ae ae . now information on receptor property has been documented in some h n viruses of clade , ae , and ae . [ ] [ ] [ ] little is known about h n virus of clade ae ae , particularly from human.recently, a , -specific sialidase-treated red blood cell (rbc) agglutination assay was developed and used for receptor specificity screening of h n virus. , the a , or a , -binding preference can be distinguished by the change of hemagglutination titer reacted with rbcs and enzymatic rbcs. since fine receptor specificity existed in h n viruses, , the glycan array including sulfated-, fucosylated-, linear sialosides, di-sialosides, or direct binding assay with synthetic polyacrylamide (paa)-based sialylglycopolymers was also recommended for the receptor-specificity surveillance on h n viruses. furthermore, the long-branched a , sialylated glycans were currently identified to predominate on the upper respiratory epithelial in human and the recognition of this topology, ¢sln-ln is the key determinant for the human-adaptation of influenza a virus. here, we analyzed the receptor-binding specificity of human h n viruses isolated in china from to . since , a total of h n infection cases were confirmed in china from provinces. the pharyngeal swabs and lower airway aspirations from the patients were collected within days after disease onset, maintained in viral-transport medium, and tested within hours.options for the control of influenza vii key: cord- -khhzlt y authors: jain, aditya; leka, stavroula; zwetsloot, gerard i. j. m. title: work, health, safety and well-being: current state of the art date: - - journal: managing health, safety and well-being doi: . / - - - - _ sha: doc_id: cord_uid: khhzlt y this introductory chapter will present a review of the current state of the art in relation to employee health, safety and well-being (hsw). the work environment and the nature of work itself are both important influences on hsw. a substantial part of the general morbidity of the population is related to work. it is estimated that workers suffer million occupational accidents and million occupational diseases each year. the chapter will first define hsw. it will then review the current state of the art by outlining key hsw issues in the contemporary world of work, identifying key needs. it will then discuss the evolution of key theoretical perspectives in this area by linking theory to practice and highlighting the need for aligning perspectives and integrating approaches to managing hsw in the workplace. this chapter focuses on the relationship between work, health, safety and wellbeing. the work environment and the nature of work itself are both important influences on health, safety and well-being (hsw). as a result, workplace health and safety or occupational health and safety have been key areas of concern for many years. traditionally, more focus has been placed on safety concerns in the workplace while health concerns became more prominent with the changing nature of work. well-being on the other hand, is increasingly being considered in relation to work and the workplace in recent years. a good starting point in understanding this evolution in focus and thinking is definitions. according to the oxford dictionary, safety is defined as the condition of being safe; freedom from danger, risk, or injury. safety can also refer to the control of recognized hazards in order to achieve an acceptable level of risk. in terms of work, this mainly concerns physical aspects of the work environment. however, the changing nature of work was associated with the emergence of new types of risk relating to psychological and social aspects of the work environment. this brought about greater focus on health at work. a very influential definition that shaped thinking and action in subsequent years was the world health organization definition of health as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity (world health organization [who], ) . this definition promoted a more holistic view of health away from a mere focus on physical aspects towards considering social and mental health aspects. although the who definition already referred to a state of well-being, definitions of well-being include additional dimensions to health, such as social, economic, psychological, and spiritual. well-being refers to a good or satisfactory condition of existence; a state characterized by health, happiness, and prosperity. obviously achieving this state is not relevant to the workplace or work alone but rather an overall evaluation of one's life across many areas. as such, actions to improve hsw can be taken within the work context and outside of it. actions taken in the workplace represent workplace interventions that are implemented in the work setting and consider the characteristics of work environments and workers. on the other hand, actions taken outside the workplace represent public health interventions that are implemented in various settings (for example, in schools, communities or countries) and take into consideration the characteristics of particular populations. a key question in terms of hsw interventions when it comes to the workplace concerns responsibility. while every individual is responsible for their own actions in various contexts of life, in a specific setting like the work environment, additional responsibility lies with the employer since the work environment will expose workers to particular work characteristics that might in turn pose a certain level of risk to their hsw. while employer responsibility might be formalized under law, this is not the case across countries or in relation to all possible types of risks to workers' hsw, and in particular new and emerging risks, or risks that are either new or gain in prevalence with the changing nature of work. accordingly, it is important to consider not only legal duties that employers have towards their workforce but also ethical duties that will extend beyond legal compliance. in addition, while employers bear a legal responsibility towards their workforce, they also bear responsibility towards society. this has meant that enterprises have increasingly been held accountable towards society and that interventions in the workplace, whether legally required or not, are now being increasingly considered in terms of their impact beyond the workforce alone but rather society as a whole (see chapters , , and ). this represents a blurring of boundaries between traditional occupational safety and health and public health initiatives that have also resulted in greater emphasis on the concept of well-being in addition to health and safety. at its first session in , the joint international labour organization (ilo)/ world health organization (who) committee on occupational health defined the purpose of occupational health. it revised the definition at its th session in to read as follows: occupational safety and health should aim at: the promotion and maintenance of the highest degree of physical, mental and social well-being of workers in all occupations; the prevention amongst workers of departures from health caused by their working conditions; the protection of workers in their employment from risks resulting from factors adverse to health; the placing and maintenance of the worker in an occupational environment adapted to his physiological and psychological capabilities; and, to summarize, the adaptation of work to man and of each man to his job. almost years later, the target set through this declaration seems ambitious in many parts of the world, both in developed and developing countries. to understand why, it is worth understanding the context underpinning developments in this area as well as current priorities and needs. in recent years, globalization of the world's economies and its repercussions have been perceived as the greatest force for change in the world of work, and consequently in the scope of occupational safety and health, in both positive and negative ways. liberalization of world trade, rapid technological progress, significant developments in transport and communication, shifting patterns of employment, changes in work organization practices, the different employment patterns of men and women, and the size, structure and life cycles of enterprises and of new technologies can all generate new types and patterns of hazards, exposures and risks. demographic changes and population movements, and the consequent pressures on the global environment, can also affect safety and health in the world of work. let us first consider key impacts on the changing nature of the work environment. different types of products and services, organizational structures and work processes, and tools and resources are used in the modern workplace. three main drivers have been proposed in relation to these changes. the first is globalization, a term which refers to the integration of national and regional economies, which became more prevalent since the nineteenth century. according to the organization for economic co-operation and development (oecd, ) , the rapid integration into world markets by six economies (brazil, russia, india, indonesia, china and south africa) was an important component of globalization during the past decades. globalization has led to increased competition across organizations, to a shift in the type of business operations in which companies are engaged, and to extensive outsourcing of activities, primarily to low-wage countries. flanagan ( ) examined the effects of globalization on working conditions (hours, remuneration and safety) and concluded that globalization has led to greater flexibility of the work process, with more part-time employment, temporary employment and independent contracting of staff (european agency for safety & health at work [eu-osha], ; kawachi, ) . houtman and van den bossche ( ) confirmed these conclusions on the basis of eurostat data, reporting that more employees in europe hold a temporary employment contract and yet more people will work 'on call'. oecd reports also confirm these trends. they also highlight that average wage growth has not been equivalent to growth in labour productivity, which is also an outcome of the erosions of the bargaining power of workers in the process of globalization (oecd, ). organizational restructuring which has been on the increase due to economic crises in different parts of the world may have been partly a cause of this. organizational restructuring is accompanied by job insecurity and can result in unemployment with subsequent negative impacts on hsw. however, restructuring should not only be considered a serious threat to individual hsw for those who lose their job (the 'direct victims') but also to their immediate environment (e.g. kieselbach et al., ). in addition, evidence during the past two decades showcases the impact of restructuring on the so-called 'survivors' as concerns health, well-being, productivity, and organizational commitment (kieselbach et al., ) . the second key development is the tertiarization of the labour market, manifested in increased demand for staff in the services sector and reduced employment opportunities in industry and agriculture. this became apparent in the early years of the twentieth century but in recent decades may have been reinforced by globalization, since the outsourcing of manual labour to low-wage countries left predominantly the service economy elsewhere (eu-osha, ; peña-casas & pochet, ) . the third key development relates to technological advancement and the emergence of the internet, which has led to many changes and innovations in work processes. many forms of manual work have become obsolete and staff must offer different skills and qualifications (joling & kraan, ) . moreover, 'new work', a term which amongst others refers to telework, i.e. working from home or a location other than the traditional office, is now more widespread. this can result in blurring the borders between working and private life. work can take place outside the traditional working hours as well as at home or when travelling. hence, it may impinge on the need for rest and recuperation, or interfere with personal commitments. also new forms of working methods such as lean production (a production practice according to which the expenditure of resources other than for the creation of value for the end customer is wasteful and should be eliminated, womack & jones, ) , and just-in-time production (a production strategy that strives to improve a business' return on investment by reducing in-process inventory and associated costs, womack & jones, ) have been introduced (eu- osha, ; kompier, ) . overall there has been concern of the effects new forms of work may have on the hsw of workers, organizations and communities (e.g. benach, amable, muntaner, & benavides, ; benavides, benach, diez-roux, & roman, ; quinlan, ; quinlan, mayhew, & bohle, ; sauter et al., ; virtanen et al., ) . it is also important to mention the prevalence of small and medium-sized enterprises (smes) that are believed to be responsible for over % of new jobs created globally. moreover, in most developing and emerging countries, they also employ more people than large enterprises do. however, occupational safety and health (osh) is often less well managed in smes, creating working conditions that are less safe and posing greater risks to the health of workers than larger enterprises (croucher, stumbitz, quinlan, & vickers, ) . in particular, smes have less time to devote to providing osh training and information due to economies of scale, and have less expertise in hsw. research also confirms a common lack of awareness of the cost implications of occupational accidents and diseases amongst sme owners and managers, as well as a tendency for smes to be reactive, rather than adopting proactive and preventive strategies towards osh (croucher et al., ) . however, there are also changes in the workforce that are associated with hsw in the workplace. the next section considers the most important of these. alongside the factors changing the nature of work itself, changes can also be seen in the working population, with noteworthy trends being: (a) the ageing workforce; (b) the feminization of the workforce; and (c) increased immigration (leka, cox, & zwetsloot, ) . let us now consider these issues in more detail. in industrialized countries, the share of people aged -plus has risen from % in to % and is expected to reach % ( million) by . in developing countries, the share of people aged -plus has risen from % in to % and is expected to reach % ( . billion) by (world economic forum [wef], ). the global population is projected to increase . times from to , but the number of -plus will increase by nearly %, and the -plus by about %. women have a life expectancy of . years more than men and account for about % of the -plus group, rising to % of the -plus group, and % of the -plus group (wef, ) . in response to these global trends, four strategies have been proposed: raising the normal legal retirement age; using international migration to ameliorate the economic effects of population ageing; reforming health systems to have more emphasiz on disease prevention and health promotion; and rethinking business practices, encouraging businesses to employ more older workers, even on a part-time basis (wef, ) . according to the oecd ( ) most countries will have a retirement age for both men and women of at least years by , and this has already been implemented in many countries. this represents an increase from current levels of around . years on average for men and . years on average for women. the same report stresses that high levels of youth unemployment will lead to widespread poverty in old age as young people struggle to save for retirement. since population ageing in industrialized nations has been a prevalent trend in the past decades (ilmarinen, ) , lessons can be learned from it in relation to the workforce. most reviews and meta-analyses in the scientific literature make clear that there is no consistent effect of age on work performance (e.g., benjamin & wilson, ; griffiths, ; salthouse & maurer, ) . overall, older workers perform as well as younger workers. furthermore, there are many positive findings with regard to older workers. for example, older workers demonstrate less turnover and more positive work values than younger workers (warr, ) . they also exhibit more positive attitudes to safety and fewer occupational injuries (siu, phillips, & leung, ) although there is some evidence that it is tenure (time on the job) that should be examined rather than age per se (breslin & smith, ) . however, the evidence from epidemiological and laboratory-based studies paints a less favourable picture of older people's performance. such studies reveal age-related declines in cognitive abilities such as working memory capacity, attention capacity, novel problem-solving, and information processing speed. agerelated deterioration is also documented in motor-response generation, selecting target information from complex displays, visual and auditory abilities, balance, joint mobility, aerobic capacity and endurance (kowalski-trakofler, steiner, & schwerha, ) . as workers get older, they suffer from more musculoskeletal disorders (eurostat, ) , and they are more likely to report work-related stress (griffiths, ) . recent models of ageing and work propose that certain mediating factors underpin the relationship between chronological age, work performance and behaviour and might function at three levels: individual, organizational and societal. at the individual level, for example, experience, job knowledge, abilities, skills, disposition, and motivation may operate (kanfer & ackerman, ) . other mediating variables may reflect organizational policies and practices: for example, age awareness programmes, supervisor and peer attitudes, management style, the physical work environment and equipment, health promotion, workplace adjustments, and learning and development opportunities (griffiths, ) . however, policies and systems implemented so far have, in most countries, not been adequately successful in keeping people healthier and in employment for longer (oecd, ) . a further level of exploration for the relationship between age and work performance might be provided by examining global markets, the wider employment context and worker protection (johnstone, quinlan, & walters, ; quinlan, ) . as discussed, in developed countries there has been a decline in manufacturing and a recent export of some service sector work to developing countries. the way work is designed and organized has changed substantially with a growth in contingent or 'precarious' work and an increase in part-time work, home-based work, telework, multiple job-holding and unpaid overtime. these changes might make it increasingly difficult for older workers to gain or maintain employment, and such employment may entail inferior and unhealthy working conditions. these changes in work design and management have also been accompanied by changes in worker protection; for example, a decline in union density and collective bargaining, some erosion in workers' compensation and public health infrastructure and cutbacks in both disability and unemployment benefits -again contexts which are unlikely to favour vulnerable workers, such as older workers. as such older workers may be affected by increased exposure to certain occupational hazards; decreased opportunities to gain new knowledge and develop new skills; less support from supervisors, and discrimination in terms of selection, career development, learning opportunities and redundancy (chiu, chan, snape, & redman, ; maurer, ; molinie, ) . pronounced gender differences in employment patterns can be observed as a result of a highly segregated labour market based on gender (burchell, fagan, o'brien, & smith, ; fagan & burchell, ; vogel, ) . gender segregation refers to the pattern in which one gender is under-represented in some jobs and overrepresented in others, relative to their percentage share of total employment (fagan & burchell, ) . a growing body of evidence indicates that a high level of gender segregation is a persistent feature of the employment structure globally (e.g. anker, ; burchell et al., ; rubery, smith, & fagan, ) . some scholars have argued that estimates suggest that gender segregation in the labour market is so pervasive, that in order to rectify this imbalance approximately % of women would have to change jobs or professions (messing, ) . considering differences in employment patterns according to gender (and without taking into account sectors where both genders are represented, e.g. agriculture), women's jobs typically involve caring, nurturing and service activities for people, whilst men tend to be concentrated in managerial positions and in manual and technical jobs associated with machinery or physical products. since men and women are differently concentrated in certain occupations and sectors, with different aspects of job content and associated tasks, they are exposed to a different taxonomy of work-related risks (burchell et al., ; eu-osha, ) . for example, women are more frequently exposed to emotionally demanding work, and work in low-status occupations with often restricted autonomy, as compared to men. this differential exposure can result in differential impacts on occupational ill health for men and women (eu-osha, ; oecd, ) . furthermore, due to the gender division of labour, women and men play different roles in relation to children, families and communities with implications for their health (premji, ) . even though women are increasingly joining the paid workforce, in most societies they continue to be mainly responsible for domestic, unpaid work such as cooking, cleaning and caring for children, and so they carry a triple burden (e.g. loewenson, ) . women are also largely represented among unpaid contributing family workers, those who work in a business establishment for a relative who lives in the same household as they do (ilo, ) . balancing responsibilities for paid and unpaid work often leads to stress, depression and fatigue (duxbury & higgins, ; manuh, ) , and can be particularly problematic when income is low and social services and support are lacking. the lack of availability of child care may also mean that women must take their children to work where they may be exposed to hazardous environments. increased migration of workers from developing countries to developed countries or from poorer to more affluent developed countries is still the norm and increasing. migrant workers can be divided into highly-educated and skilled workers, both from developing and industrialized countries, and unskilled workers from developing countries (takala & hämäläinen, ) . they can also be classified as legal and illegal (or regular and irregular) migrant workers who have a different status and, therefore, varying levels of access to basic social services (who, ) . often lowskilled and seasonal workers are concentrated in sectors and occupations with a high level of occupational health and safety risks (who, ) . ethnic minority migrants have been found to have different conditions in comparison to other migrants, and to report lower levels of psychological well-being (shields & price, ) . women migrants represent nearly half of the total migrants in the world and their proportion is growing, especially in asia. they often work as domestic workers or caregivers while men often work as agricultural or construction workers (ilo, ) . in general, migrant workers tend to be employed in high risk sectors, receive little work-related training and information, face language and cultural barriers, lack protection under the destination country's labour laws and experience difficulties in adequately accessing and using health services. common stressors include being away from friends and family, rigid work demands, unpredictable work and having to put up with existing conditions (magana & hovey, ) . in addition, migrant workers' cultural background, anthropometrics and training may differ from those of nationals of host countries, which may have implications in relation to their understanding and use of equipment (kogi, ; o'neill, ) . as can be understood so far, both the nature of work and of workplaces as well as workforce characteristics depend on wider socioeconomic and political influences. a large body of literature has summarized and examined these influences under the area of the social determinants of health. the following section briefly considers these determinants. new forms of work organization and employment have to be considered within the wider picture of employment and working conditions across the world. labour markets and social policies determine employment conditions such as precarious or informal jobs, child labour or slavery, or problems such as having high insecurity, low paid jobs, or working in hazardous conditions, all of which heavily influence health inequalities. figure . shows various interrelationships between employment, working conditions and health inequalities. let us consider unemployment and associated job insecurity as social determinants of health. in the ilo estimated that there were almost million unemployed people in the eu, million of whom were from eu- countries. overall, million people were unemployed in with a quarter of the increase of four million in global unemployment being in the advanced economies, and three quarters being in other regions, with marked effects in east asia, south asia and sub-saharan africa (ilo, a). the same report also highlighted that in those regions where unemployment did not increase further, job quality worsened as vulnerable employment and the number of workers living below or very near the poverty line increased. in the eu, the financial crisis resulted in unprecedented levels of youth unemployment, averaging % for the eu as a whole. the rates for young people (aged - ) not in employment, education or training are . % in the south and peripheral eu countries, and . % in the north and core of the eu (european commission [ec], ). in a pattern intensified by the financial crisis, structural unemployment has been growing and unemployment varies from . % in the south of the eu and peripheries in , to . % in the north and central countries (ec, ) . a large proportion of jobs destroyed were in mid-paid manufacturing and construction occupations (european foundation for the improvement of living & working conditions [eurofound] , ). as a consequence of reduced employment opportunities, poverty has increased in the eu since . household incomes are declining and . % of the eu population is now at risk of poverty or exclusion. children are particularly affected as unemployment and jobless households have increased, together with in-work poverty (ec, ) . this has implications for quality of life and general population health beyond workplace health and safety due to the impact on personal finances. an ilo report summarized the potential impact of financial crises on organizations and health and safety as shown in table . . the surge of unemployment creates tension and negatively impacts public perceptions for social welfare, job security, and financial stability. increased job insecurity reflects the fear of job loss or the loss of the benefits associated with the job (e.g. health insurance benefits, salary reductions, not being promoted, changes in workload or work schedule). it is one of the major consequences of today's turbulent economies and is common across occupations, and both private and publicsector employees (ashford, lee, & bobko, ; ferrie et al., ; sverke, hellgren, & naswall, ) . several studies have shown that job insecurity has detrimental effects on the physical and mental health of employees, and on many organizational outcomes, including performance, job satisfaction, counterproductive behaviours, and commitment (e.g. ferrie et al., ; sverke et al., ) . increased unemployment has given rise to different forms of flexible and temporary employment, also through the introduction of relevant policies such as flexicurity. flexicurity is an integrated strategy for enhancing flexibility and security in the labour market. it attempts to reconcile employers' need for a flexible workforce with workers' need for security (ec, ) . however, several studies have warned of the possible negative outcomes of new types of work arrangements, highlighting that they could be as dangerous as unemployment for workers' health (benach & muntaner, ) . for example, workers on fixed-term contracts are commonly found to have inadequate working conditions by comparison with permanent employees. new forms of work organization and patterns of employment can be summarized in terms of flexible working practices including temporary and part-time employment, tele-working, precarious employment, and home working. although these new practices can result in positive outcomes such as more flexibility, a better worklife balance, and increased productivity, research has also identified several potential negative outcomes. for example, teleworkers may feel isolated, lacking support and career progression (e.g. ertel, pech, & ullsperger, ; schultz & edington, ) . in addition, temporary, part-time and precarious employment can result in higher job demands, job insecurity, lower control and an increased likelihood of labour force exit (benach et al., ; quinlan, ; quinlan et al., ) . workers engaged in insecure and flexible contracts with unpredictable hours and volumes of work are more likely to suffer occupational injuries (ilo, a (ilo, , b . although awareness and evidence in developing countries lags far behind those in the industrialized world, evidence has started to accumulate showing similar findings in developing countries (kortum, leka, & cox, ) . these various complex relationships between the wider socio-economic context, employment and working conditions have resulted in a more complex profile of risk factors that may affect hsw in the workplace. new forms of work organization and the move towards a service based economy have also resulted in new and emerging risks affecting the workforce, organizations and society. these will be considered next. an 'emerging osh risk' is often defined as any occupational risk that is both new and increasing (eu-osha, ). new means that the risk was previously unknown and is caused by new processes, new technologies, new types of workplaces, or social or organizational change; or, a long-standing issue is newly considered to be a risk due to changes in social or public perceptions; or, new scientific knowledge allows a long standing issue to be identified as a risk. a risk is increasing if the number of hazards leading to the risk is growing; or, the likelihood of exposure to the hazard leading to the risk is increasing (exposure level and/or the number of people exposed); or the effect of the hazard on workers' health is getting worse (seriousness of health effects and/or the number of people affected) (houtman, douwes, zondervan, & jongen, ). an article published on eu-osha's osh wiki on new and emerging risks summarizes them as follows (houtman et al., ) : • emerging physical risks: ( ) physical inactivity and ( ) the combined exposure to a mixture of environmental stressors that increase the risks of musculoskeletal disorders (msds), the leading cause of sickness absence and work disability. • emerging psychosocial risks: ( ) job insecurity, ( ) work intensification, high demands at work, and ( ) emotional demands, including violence, harassment and bullying. • emerging dangerous substances due to technological innovation: ( ) chemicals, with specific attention to nanomaterials, and ( ) biological agents. the growing use of computers and automated systems, aimed at optimizing productivity, has caused an increase in sedentary work or prolonged standing at work, resulting in an increase in physical inactivity. work demands are also commonly cited as reasons for physical inactivity (e.g. trost, owen, bauman, sallis, & brown, ) as well as an increase in travelling time to work (houtman et al., ) . physical inactivity is associated with increased health risks such as coronary heart disease, type ii diabetes, and certain types of cancers and psychological disorders (depression and anxiety) (department of health, ; who, ; zhang, xie, lee, & binns, ) . another important result of inactivity is obesity which can lead to several adverse health effects, such as back pain, high blood pressure, cardiovascular disorders, and diabetes (houtman et al., ) . in addition, sedentary jobs are associated with an increased prevalence of musculoskeletal complaints or disorders, e.g. neck and shoulder disorders (e.g. korhonen et al., ) , and upper and lower back disorders (e.g. chen, mcdonald, & cherry, ) . such disorders may lead to sick leave and work disability (e.g. steensma, verbeek, heymans, & bongers, ) . the established health risks associated with sedentary work are premature death in general, type ii diabetes and obesity (van uffelen et al., ) . as concerns msds, there is a considerable body of research indicating that biomechanical or ergonomic risks in combination with psychosocial risks can generate work-related msds (e.g. bongers, ijmker, & van den heuvel, ; briggs, bragge, smith, govil, & straker, ; eu-osha, ) . psychosocial risk factors at work have a greater effect on the prevalence of musculoskeletal complaints when exposure to physical risk factors at work is high rather than when it is low. in addition, factors such as low job control, high job demands, poor management support or little support from colleagues, as well as restructuring, job redesign, outsourcing and downsizing have been shown to be causally related to increased risks in msds (houtman et al., ) . job insecurity has been discussed earlier and is an important stressor resulting in reduced well-being (psychological distress, anxiety, depression, and burnout), reduced job satisfaction (e.g. withdrawal from the job and the organization) and increased psychosomatic complaints as well as physical strains (e.g. wagenaar et al., ) . all these effects are negatively related to personal growth as well as to recognition and participation in social life (de cuyper et al., ) . additionally, decreased well-being and reduced job satisfaction of employees negatively affects the effectiveness of the organization (houtman et al., ) . there are several increasing demands workers are exposed to in the modern workplace including: quantitative (high speed, no time to finish work in regular working hours), qualitative (increased complexity), emotional (emotional load due to direct contact with customers i.e. service relationship situations), and often physical loads as well (houtman et al., ) . the widespread use of information and communication technology (ict) has led to work intensification. developments in technology use in terms of mechanization, automation, and computerization, has led to the substitution of human activities by machines. on the other hand, the use of computers and smart phones with internet access provides easy access to all kinds of information but may also lead to the expectation from colleagues, supervisors and clients that one is always available and can be contacted (e.g. by email). ict work may then lead to stress symptoms due to excessive working hours, workload and increasing complexity of tasks or isolation in home workers; information overload; pressure of having to constantly upgrade skills; human relationships replaced by virtual contacts; and physical impairments such as repetitive strain injuries and other msds due to using inadequate or ergonomically unadapted equipment (houtman et al., ) . psychosocial hazards such as high job demands and low control have been systematically found to be causally linked to cardiovascular heart disease (e.g. backé, seidler, latza, rossnagel, & schumann, ; eller et al., ) , msds (e.g. da costa & vieira, ) as well as mental health problems such as depression and anxiety (e.g. bonde, ; netterstrom et al., ) . in addition, long term absence and disability are causally related to these types of risks (e.g. duijts, kant, swaen, brandt, & van den zeegers, ) . furthermore, as the labour market shifts towards the service industry, emotional demands at work increase with harassment or bullying and violence contributing to this increase (houtman et al., ) . those affected by violence and harassment in the workplace tend to report higher levels of work-related ill health. the proportion of workers reporting symptoms such as sleeping problems, anxiety and irritability is nearly four times greater among those who have experienced violence, bullying and harassment than amongst those who have not (houtman et al., ) . nanotechnology has been defined as the design, characterization, production and application of structures, devices and systems by controlling shape and size at nanometre scale (eu-osha, ). due to their small size, engineered nanomaterials (enms) have unique properties that improve the performance of many products. nanomaterials have applications in many industrial sectors (currently the main areas are materials and manufacturing industry including automotive, construction and chemical industry, electronics and it, health and life sciences, and energy and environment). a key issue of enms is the unknown human risks of the applied nanomaterials during their life cycle, especially for workers exposed to enms at the workplace. workers in nanotechnology may be exposed to novel properties of materials and products causing health effects that have not yet been fully explored. the manufacture, use, maintenance and disposal of nanomaterials may have potential adverse effects on internal organs (eu-osha, ). although there is a considerable lack of knowledge, there are indications that because of their size, enms can enter the body via the digestive system, respiratory system or the skin. once in the body, enms can translocate to organs or tissue distant from the portal of entry. such translocation is facilitated by the propensity of the nanoparticles to enter cells, to cross membranes and to move along the nerves (iavicoli & boccuni, ) . the enms may accumulate in the body, particularly in the lungs, the brain and the liver. the basis for the toxicity appears to be primarily expressed through an ability to cause inflammation and to raise potential for autoimmune deficits, and may induce diseases such as cancer (houtman et al., ) . other dangerous substances concerns include diesel exposure and its link to lung cancer and non-cancer damage to the lung; and man-made mineral fiber exposure (classified as being siliceous or non-siliceous) and the link of their structure to inflammatory, cytotoxic and carcinogenic potential (houtman et al., ) . another three chemical risks have been identified as emerging with a view to allergies and sensitizing effects. they are epoxy resins, isocyanates and dermal exposure (eu-osha, ). epoxy resins have become one of the main causes of occupational allergic contact dermatitis. skin sensitization of the hands, arms, face, and throat as well as photosensitization have also been reported. isocyanates are powerful irritants to the mucous membranes of the eyes and of the gastrointestinal and respiratory tracts. direct skin contact can cause serious inflammation and dermatitis. isocyanates are also powerful asthmatic sensitizing agents (houtman et al., ) . finally, risks related to global epidemics are the most important biological risk issue. pathogens such as the severe acute respiratory syndrome (sars), ebola, and marburg viruses are new or newly recognized. in addition, new outbreaks of wellcharacterized outbreak-prone diseases such as cholera, dengue, measles, meningitis, and yellow fever still emerge (houtman et al., ) . it should be stressed that the profile of risks in the workplace constantly changes and there are additive effects that exacerbate negative impacts. the following section provides an overview of key challenges in relation to hsw in the modern workplace while also acknowledging the lack of research in relation to some of the new and emerging risks identified earlier. the ilo has published global estimates of fatal and non-fatal occupational (ilo, ) and fatal work-related diseases (ilo, b). . million deaths occur annually across countries for reasons attributed to work. over , are caused by occupational accidents while the biggest mortality burden comes from work-related diseases, accounting for about million deaths. globally, cardiovascular and circulatory diseases at % and cancers at % were the top illnesses responsible for / of deaths from work-related diseases, followed by occupational injuries at % and infectious diseases at %. as a result, approximately people die every day due to these causes: occupational accidents kill nearly people every day and work-related diseases provoke the death of approximately more individuals. there were also over million non-fatal occupational accidents (requiring at least four days of absence from work) in , meaning that occupational accidents provoke injury or ill health for approximately , people every day (ilo, b). major industrial accidents are stark reminders of the unsafe conditions still faced by many. for example, the april collapse of the rana plaza building in bangladesh resulted in the death of individuals and injured more, mostly factory workers making garments for overseas retail chains. the international community has since expressed concerns about market pressures which strive to keep basic production costs low, the role of national authorities, and the responsibilities of multinational enterprises and other stakeholders in supply chains towards the health and safety of workers. hazardous sectors such as mining, construction, shipping, and in particular fishing continue to take a heavy toll on human lives and health. meanwhile, the nuclear industry continues to pose serious problems regarding the radiological protection of site workers and the environment. in particular, the protection of emergency workers at the fukushima daiichi power plant in japan has become a focus of international attention since the east japan earthquake. occupational health has recently become a much higher priority, in light of the growing evidence of the enormous loss and suffering caused by occupational diseases and ill health across many different employment sectors. even though it is estimated that fatal diseases account for about % of all work-related fatalities, more than half of all countries do not provide official statistics for occupational diseases (ilo, b). these therefore remain largely invisible, compared to fatal accidents. moreover and as discussed previously, the nature of occupational diseases is changing rapidly, as new technologies and global social changes aggravate existing health risks and create new ones. for example, long-latency diseases include illnesses such as silicosis and other pneumoconioses, asbestos-related diseases and occupational cancers that may take decades to manifest. such diseases remain widespread, as they are often undiagnosed until they result in permanent disability or premature death. pneumoconioses account for a high percentage of all occupational diseases. for example, in latin america, there is a % prevalence rate of silicosis amongst miners, and this figure reaches % among miners over the age of . in vietnam, pneumoconioses account for . % of all compensated occupational diseases (ilo, b) . the use of asbestos has been banned in more than counties, including all eu member states, but the number of deaths from asbestos-related diseases is increasing in many industrialized countries because of exposure that occurred during the s and later. in germany and the uk, for example, the number of deaths from asbestos-induced mesothelioma has been increasing for some years and was expected to peak in - (health & the number of cases of work-related stress, violence and psychosocial disorders has also been increasing. these have often been attributed at least in part to recession-driven enterprise restructuring and redundancies which can be very damaging psychologically. european studies have shown that a large and rapid rise in unemployment has been associated with a significant increase in suicide rates (e.g. lundin & hemmingsson, ). meanwhile, a review of mortality studies in countries across the world has also shown an increase in cardiovascular mortality rates by an average of . % in periods of crisis (falagas, vouloumanou, mavros, & karageorgopoulos, ) . the impact of the issues discussed in this section is presented in chapter . on the basis of the available evidence, it is now recognized that a new paradigm of prevention is required, one that focuses on work-related diseases and not only on occupational injuries. recognition, prevention and treatment of both occupational diseases and accidents, as well as the improvement of recording and notification systems are high priorities for improving the health of individuals and the societies they live in. several perspectives and associated approaches have been taken to promote hsw in the workplace over the years as priorities change and new issues and knowledge emerge. the following section will provide an overview of some key perspectives that have led to the development of modern holistic models to promote hsw in the workplace. the field of occupational health and safety has been defined as the science of the anticipation, recognition, evaluation and control of hazards arising in or from the workplace that could impair the hsw of workers, taking into account the possible impact on the surrounding communities and the general environment (alli, ) . given the broad scope of this definition, several disciplines are relevant to osh that relate to control of the multitude of hazards in the workplace. furthermore, since social, political, technological and economic changes are constantly impacting upon the workplace, the field of osh has been evolving to address new and emerging issues in line with different perspectives. some disciplines of relevance to osh include engineering, ergonomics, toxicology, hygiene, medicine, epidemiology, psychology, sociology, education, and policy. these disciplines often diverge in terms of theoretical foundation and as a result emphasize different aspects in terms of understanding and dealing with osh issues. however, in recent years there has been convergence in thinking about the work environment and a trend towards more holistic perspectives and approaches when considering hsw. indeed, while hsw issues were in the past approached from a mono-disciplinary perspective, multi-disciplinarity is now advocated as the necessary way forward. however, in practice osh professionals often still employ mono-disciplinary perspectives in dealing with accidents and diseases in the workplace, seeking to protect individual workers rather than preventing negative impacts of the work environment and promoting positive outcomes. solely focusing on ameliorating harm rather than promoting hsw has also been criticized in recent years by scholars emphasizing a salutogenic (health promoting) instead of a pathogenic (disease preventing) perspective. let us now consider some of these approaches further in relation to safety, health and well-being. it has been argued that occupational safety has developed and evolved through three ages: . a technical age, . a human factors age, and . a management and culture age (hale & hovden, ) (or as hudson, described them through a technical wave, a systems wave and a culture wave). several authors have since then suggested new ages in safety science. the first age of safety concerned itself with the technical measures to guard machinery, stop explosions and prevent structures collapsing. it lasted from the nineteenth century through until after the second world war and was interested in accidents having technical causes (hale & hovden, ) . the period between the world wars saw the development of research into personnel selection, training and motivation as prevention measures, often based on theories of accident proneness (see hale & glendon, for a review; burnham, for the accident-prone theory). this brought about the second age of safety, which developed separately to technical measures until the period of the s and s, when developments in probabilistic risk analysis and the rise and influence of ergonomics led to a merger of the two approaches in health and safety. there was a move away from an exclusive dominance of the technical view of safety in risk analysis and prevention, and the study of human error and human recovery or prevention came into its own (hale & hovden, ) . just as the second age of human factors was ushered in by increasing realizations that technical risk assessment and prevention measures could not solve all problems, so were the s characterized by an increasing dissatisfaction with the idea that health and safety could be captured simply by matching the individual to technology. in the s management and culture were the focus of development and research, based on many influential thinkers such as heinrich who published his ground-breaking safety management textbook in heinrich, , the sociotechnical management literature (e.g. elden, ; thorsrud, ; trist & bamforth, ) , the social organizational theory of lewin ( ) , the loss prevention approach (bird, ) , and the introduction of participative management in safety (e.g. simard & marchand, ) . however, reason ( ) contended that an over-reliance on osh management systems and insufficient understanding of, and insufficient emphasis on, workplace culture, can lead to failure because "it is the latter that ultimately determines the success or failure of such systems" (p. ). criticism of overreliance on systems was also influenced by the resilience engineering school that posited that instead of focusing on failures, error counting and decomposition, we should address the capabilities to cope with the unforeseen. the ambition is to 'engineer' tools or processes that help organizations to increase their ability to operate in a robust and flexible way. hopkins ( ) views safety culture as one aspect of organizational culture, or more particularly an organizational culture that is focused on safety. further, culture is viewed as a group, not an individual, phenomenon; efforts to change culture, should, in the first instance, focus on changing collective practices (the practices of both managers and workers) and the dominant source of culture is what leaders pay attention to. much of hopkins' work draws on reason's ( ) notion that a safe culture is an informed culture and sutcliffe's ( , ) principles of collective mindfulness and high reliability organizations (i.e. organizations that are able to manage and sustain almost error-free performance despite operating in hazardous conditions where the consequences of errors could be catastrophic). collective mindfulness is based on the premise that variability in human performance enhances safety whilst unvarying performance can undermine safety, particularly in complex socio-technical systems. glendon, clarke, and mckenna ( ) argued that each of the first three periods of development build on one another and refer to this process of development as the fourth age of safety or the integration age where previous ways of thinking are not lost, but remain available to be reflected upon as multiple, more complex perspectives develop and evolve. however, as the limitations of osh management systems and safety rules that attempt to control behaviour have become evident, it has also been proposed that a fifth age of safety has emerged, the adaptive age; an age which transcends the other ages of safety. the adaptive age challenges the view of an organizational safety culture and instead recognizes the existence of socially constructed sub-cultures. the adaptive age embraces adaptive cultures and resilience engineering and requires a change in perspective from human variability as a liability and in need of control, to human variability as an asset and important for safety (borys, else, & leggett, ) . resilience engineering is similar to collective mindfulness since it also focuses on the importance of performance variability for safety. however, what sets resilience engineering apart from collective mindfulness is the focus on learning from successful performance (hollnagel, ) , i.e. why things go right as well as why things go wrong (also called the safety approach (hollnagel, ) . one particular major development in the safety evolution was the move towards managing risks in the work environment. this implied that it is impossible to completely control all aspects of work to avoid negative outcomes, risks always remain. in an ever-changing work environment, a continuous assessment of risks is needed that will point to key risks that may pose a threat to workers' hsw. these then need to be managed following appropriate actions at various levels with the focus being on prevention. the risk management paradigm has been hugely influential not only in terms of managing safety but also managing health as will be discussed in the following sections. let us then consider it further next. in the wake of the chernobyl disaster in , sociologist ulrich beck published 'risikogesellschaft', later published in english as 'risk society: towards a new modernity' in . beck argued that environmental risks had become the predominant product of industrial society. he defined a risk society as "a systematic way of dealing with hazards and insecurities induced and introduced by modernization itself" (beck, , p. ) . while according to british sociologist anthony giddens ( ) , a risk society is a society that is increasingly preoccupied with the future (and also with safety), which generates the notion of risk. giddens ( ) defined two types of risks as external risks (for example natural disasters) and manufactured risks (for example, those derived from industrial processes. as manufactured risks are the product of human activity, authors like giddens and beck argue that it is possible for societies to assess the level of risk that is being produced, or that is about to be produced, in order to mitigate negative outcomes (i.e. responsibility with managing these risks lies with society and more precisely with experts able to do so). one such area is osh risk management. hazard, something that can cause harm if not controlled, is a key term in osh risk management. the outcome is the harm that results from an uncontrolled hazard. in the context of osh, harm describes the direct or indirect degradation, temporary or permanent, of the physical, mental, or social well-being of workers. a risk is a combination of the probability that a particular outcome will occur and the severity of the harm involved (nunes, ) . hazard identification or assessment is an important step in the overall risk assessment and risk management process. through this, hazards are identified, assessed and controlled/eliminated as close to source as reasonably as possible. as technology, resources, social expectations or regulatory requirements change, hazard analysis focuses control measures more closely towards the source of the hazard aiming at prevention. hazard-based programmes may not be able to eliminate all risks to hsw but they avoid implying that there are 'acceptable risks' in the workplace (nunes, ) . a risk assessment needs to be carried out prior to making an intervention. this assessment should identify hazards, identify all affected by the hazard and how, evaluate the risk, and identify and prioritize appropriate control measures. the calculation of risk is based on the likelihood or probability of the harm being realized and the severity of the consequences. the assessment should be recorded and reviewed periodically and whenever there is a significant change to work practices. the assessment should include practical recommendations to control the risk. once recommended controls are implemented, the risk should be re-calculated to determine if it has been lowered to an acceptable level (nunes, ) . risk assessment and calculation is usually easier as regards physical risks but more complex as regards biological, and even more so psychosocial, risks. despite this, the risk management paradigm has been applied to all these types of risks to hsw, and is used extensively both as concerns occupational injury and occupational health. it also represents the cornerstone of osh legislation across countries. osh management systems are based on this paradigm (see chapter for more details). following the pdca (plan-do-check-act) cycle methodology (deming, ) , risk management is a systematic process that includes the examination of all characteristics of the work system where the worker operates, namely, the workplace, the equipment/machinery, materials, work methods/practices and work environment. the main goal of risk management is to eliminate or at least to reduce the risks that cannot be avoided or eliminated to an acceptable level. risk management measures should follow the hierarchy of control principles of prevention, protection and mitigation. worker participation is key in the process of risk management. the risk management process should be reviewed and updated regularly, for instance every year, to ensure that the measures implemented are adequate and effective. additional measures might be necessary if the improvements do not show the expected results (nunes, ) . periodic risk management is also important since workplaces are dynamic due to changes in equipment, substances or work procedures, and new hazards might emerge. another reason is that new knowledge regarding risks can become available, either leading to the need of an intervention or offering new ways of controlling the risk. the review of the risk management process should consider a variety of types of information and draw them from a number of relevant perspectives (e.g. staff, management, stakeholders). however, risk management has been criticized for focusing too heavily on avoiding (controlling) possible negative outcomes and not promoting positive and healthy work environments. this development in thinking has stemmed from a parallel move from pathogenic to salutogenic approaches in health and its management. this evolution in thinking about health and well-being will be considered next. approaches in occupational health and occupational hygiene have evolved in line with developments in several disciplines, including safety engineering, medicine and psychology. the risk management perspective is the cornerstone of occupational hygiene as is evident by its definition. the international occupational hygiene association (ioha, n.d.) refers to occupational hygiene as the discipline of anticipating, recognizing, evaluating and controlling health hazards in the working environment with the objective of protecting worker health and well-being and safeguarding the community at large. although occupational health definitions similarly place great focus on managing risk factors, they overall refer to the promotion and maintenance of health and well-being of employees. similarly to the evolution of perspectives in safety, these definitions have been influenced by the evolution of thinking on health and well-being over the years (schulte & vainio, ) . perspectives on health and illness started with a focus on pathogenesis, as pioneered and developed by williamson and pearse ( ) which is the study of disease origins and causes. pathogenesis starts by considering disease and infirmity and then works retrospectively to determine how individuals can avoid, manage, and/or eliminate that disease or infirmity. the dose-response relationship of the change in effect on an organizm caused by differing levels of exposure (or doses) to a stressor after a certain exposure time was influential in treating disease and illness (as was in chemical safety). this leads professionals using pathogenesis to be reactive because they respond to situations that are currently causing or threatening to cause disease or infirmity (becker, glascoff, & felts, ) . a major shift came in with antonovsky's concept of salutogenesis, the study of health origins and causes, which starts by considering health and looks prospectively at how to create, enhance, and improve physical, mental and social well-being (antonovsky, ) . the assumption of salutogenesis that action needs to occur to move the individual towards optimum health, prompts professionals to be proactive because their focus is on creating a new higher state of health than is currently being experienced (antonovsky, ) . the difference between the biomedical model (based on pathogenesis) and health promotion which is now the cornerstone of public health (based on salutogenesis) is a move away from risk and disease towards resources for health and life (eriksson & lindström, ) , initiating processes not only for health but wellbeing and quality of life. perceived good health is a determinant of quality of life. according to breslow ( ) , the first era of public health involved combating communicable diseases while the second dealt with chronic diseases. their focus was on developing and maintaining health since health provides a person the potential to have the opportunity and ability to move towards the life they want. to facilitate management of health in the first two eras, measurement of the signs, symptoms and associated risks of disease and infirmity were of paramount importance. in the third era of public health most people expect a state of health that enables them to do what they want in life. to facilitate management of an evolved health status, it is necessary to develop new health measures that must go beyond detecting pathogenesis and its precursors to measuring those qualities associated with better health (breslow, ) . however, salutogenesis also presumes that disease and infirmity are not only possible but likely because humans are flawed and subject to entropy (antonovsky, ) . according to a salutogenic perspective, each person should engage in health promoting actions to cause health while they secondarily benefit from the prevention of disease and infirmity. pathogenesis, on the other hand in a complementary fashion primarily focuses on prevention of disease and infirmity, with a secondary benefit of health promotion. both approaches are needed to facilitate the goal of better health and a safer and more health enhancing environment. pathogenesis improves health by decreasing disease and infirmity and salutogenesis enhances health by improving physical, mental, and social well-being. together, these strategies will work to create an environment that nurtures, supports, and facilitates optimal well-being (becker et al., ) . around the same time when salutogenesis was introduced, in a article in science, psychiatrist george l. engel introduced a new medical model, the biopsychosocial model. the biopsychosocial model is a broad view that attributes disease outcome to the intricate, variable interaction of biological factors (genetic, biochemical, etc.), psychological factors (mood, personality, behaviour, etc.), and social factors (cultural, familial, socioeconomic, medical, etc.) . it holds to the idea that biological, psychological, and social processes are integrally and interactively involved in physical health and illness. it was pioneering in advocating the premise that people's psychological experiences and social behaviours are reciprocally related to biological processes. as a result, interventions should address all these dimensions and not narrowly focus on limited perspectives (such as only the biological perspective for example). more focus was now placed on psychological and social factors in the understanding of health and illness. indeed, the traditional medical model of ill health was increasingly recognized as having achieved limited success in tackling occupational health conditions such as stress, anxiety, depression and msds (white, ) . these challenges which have been shown to now have an increasing prevalence in the workplace (as discussed earlier), do not have a clear underlying physical basis nor do they demonstrate a linear relationship between injury, pain and disability. instead, they appear to be strongly mediated by psychological and social factors. accordingly, waddell ( ) categorized such conditions as 'common health problems'. the challenges presented by common health problems contrasts with the past success of occupational medicine in dealing with conditions that have an identifiable cause and a clear relationship between dose and response (waddell & burton, ) . the psychological models that were developed within the fields of occupational, and occupational health psychology, mainly to make sense of the concept of stress, were similarly influenced by conceptualizations of health, illness and safety. early models viewed stress either as a noxious stimulus in the environment (engineering models, derived from engineering) or a response to exposure to aversive of noxious characteristics of the environment (physiological models, derived from medicine). contemporary models focus on the interaction between the environment and the individual and emphasize either explicitly or implicitly the role of psychological processes, such as perception, cognition, and emotion (psychological models). these appear to determine how the individual recognizes, experiences, and responds to stressful situations, how they attempt to cope with that experience and how it might affect their physical, psychological, and social health (cox & griffiths, ) . the risk management paradigm remains an influential perspective in dealing with new and emerging risks in the psychosocial work environment. however, while we are a long way from the challenge of work-related stress being tackled effectively, there has started to be a shift towards promoting well-being at work and not only preventing stress and its associated negative outcomes in terms of both health and safety. this shift has followed trends in public health (discussed earlier) and also psychology towards more positive concepts. the positive psychology movement, championed by seligman and csikszentmihalyi ( ) , is an attempt to shift the emphasis in psychology away from a preoccupation with the pathological, adverse and abnormal aspects of human behaviour and experience. the positive psychology literature offers a number of perspectives that help with understanding how well-being can arise in work situations (lunt et al., ) . for example, the concept of flow was introduced by csikszentmihalyi ( ) which can be defined as a subjective condition where an individual is fully absorbed in, and engaged with, the task he or she is carrying out, promoting an experience of competence and fulfillment. as is evident from our discussion on perspectives on hsw so far, several useful models have been proposed from various disciplines with parallel developments can be observed across these disciplines. however, it should also be noted that often scholars and practitioners operate in silos, ignoring the interplay among the various approaches, and lessons that can be learned from one another. the recent focus on well-being has brought about the question of whether approaches in the workplace should focus only on factors influencing the individual's experience in the work environment or wider influences, considering more the social determinants of health discussed at the beginning of this chapter. in line with this thinking, some holistic models have emerged that recognize the interplay between workplace and non-workplace factors in determining hsw that will be discussed next. the starting point in the development of holistic models of hsw is the recognition that safety and health are different to well-being. as discussed at the beginning of this chapter, well-being refers to a good or satisfactory condition of existence; a state characterized by health, happiness, and prosperity. in particular, three key concepts have been discussed as relevant to well-being: happiness, quality of life and resilience (lunt et al., ) . layard ( ) defined happiness as feeling good; its inverse is feeling bad and wishing for a different experience. factors that affect our levels of happiness include among others family relationships, our financial situation, work, community and friends, our health, personal freedom and personal values. quality of life overlaps with contemporary interpretations of happiness. quality of life is a subjective state that encompasses physical, psychological, and social functioning. a defining feature of quality of life is its basis on the perceived gap between actual and desired living standards. resilience of individuals has been described as partly a context dependent characteristic, in that what enables resilience in one environment may be less adaptive in another (lunt et al., ) . increasingly it is recognized that resilience is important at different organizational levels (teams, organizations) and that these different levels are to some degree interacting (e.g. schelvis, zwetsloot, bos, & wiezer, ) . it is also important to recognize that even though well-being at work may be primarily an employer's responsibility (as well as the worker's), well-being of the worker or workforce is also the responsibility of others in society (e.g. governments, insurance companies, unions, faith-based and non-profit organizations) or may be affected by non-work domains (schulte et al., -see also chapter ). indeed, the well-being of the workforce extends beyond the workplace, and public policy should consider social, economic, and political contexts. schulte et al. ( ) also provide examples of holistic policy models aiming at the promotion of well-being in the workplace that include the who healthy workplace model and the niosh total worker health model (discussed in the next chapter). to promote hsw holistically, there needs to be synergy and integration among the various perspectives. to achieve this, these perspectives need to be aligned considering current knowledge and existing needs, developing capabilities, and mainstreaming a strategic approach in policy and practice. the following chapter considers key policy approaches to managing hsw at the macro level (international, regional, national), meso level (sectoral), and micro level (organizational). subsequent chapters further consider how alignment across perspectives can be achieved in policy and practice. this chapter has provided an overview of the current state of the art in relation to hsw in the workplace as regards key determinants, outcomes and perspectives. with the changing nature of work and new characteristics of the workforce, new challenges are emerging in the workplace. perspectives on how to address these challenges have changed in line with these developments as well as the evolution of knowledge and the impact of wider socio-economic and political factors. emerging issues such as psychosocial factors, the increasing prevalence of non-communicable diseases, and the shift towards well-being (and not merely safety and health) demand new ways of thinking in addressing hsw in the workplace. continuing to work in silos and adopting mono-disciplinary perspectives will not allow us to move forward in this complex landscape. a strategic alignment of perspectives and integrated approaches are needed. this book aims to promote a way forward by outlining and critically evaluating developments in hsw in the workplace, and providing a framework for action in policy and practice. fundamental principles of occupational health and safety gender and jobs: sex segregation of occupations in the world health, stress and coping the salutogenic model as a theory to guide health promotion content, cause, and consequences of job insecurity: a theory-based measure and substantive test the role of psychosocial stress at work for the development of cardiovascular diseases: a systematic review risk society: towards a new modernity salutogenesis years later: where do we go from here? the consequences of flexible work for health: are we looking at the right place precarious employment and health: developing a research agenda employment, work and health inequalities: a global perspective how do types of employment relate to health indicators? findings from the second european survey on working conditions facts and misconceptions about age, health status and employability management guide to loss control psychosocial factors at work and risk of depression: a systematic review of the epidemiological evidence epidemiology of work related neck and upper limb problems: psychosocial and personal risk factors (part i) and effective interventions from a bio behavioural perspective (part ii) the fifth age of safety: the adaptive age trial by fire: a multivariate examination of the relation between job tenure and work injuries health measurement in the third era of health prevalence and associated factors for thoracic spine pain in the adult working population: a literature review working conditions in the european union: the gender perspective accident prone: a history of technology, psychology, and misfits of the machine age incidence and suspected cause of workrelated musculoskeletal disorders age stereotypes and discriminatory attitudes towards older workers: an east-west comparison work-related stress: a theoretical perspective can better working conditions improve the performance of smes? an international literature review flow: the psychology of optimal experience risk factors for work-related musculoskeletal disorders: a systematic review of recent longitudinal studies literature review of theory and research on the psychological impact of temporary employment: towards a conceptual model at least five a week: evidence on the impact of physical activity and its relationship to health (a report from the chief medical officer) a meta-analysis of observational studies identifies predictors of sickness absence work-life balance in the new millennium: where are we? where do we need to go? democratization and participative research in the developing of local theory work-related psychosocial factors and the development of ischemic heart disease: a systematic review the need for a new medical model: a challenge for biomedicine a salutogenic interpretation of the ottawa charter working hours and health in flexible work arrangements women, men and working conditions in europe how to tackle psychosocial issues and reduce work-related stress priorities for occupational safety and health research in the eu- expert forecast on emerging psychosocial risks related to occupational safety and health european agency for safety and health at work (eu-osha) priorities for occupational safety and health research in europe communication from the commission to the european parliament, the council, the european economic and social committee and the committee of the regions -towards common principles of flexicurity: more and better jobs through flexibility and security report on the current situation in relation to occupational diseases' systems in eu member states and efta/eea countries, in particular relative to commission recommendation / /ec concerning the european schedule of occupational diseases and gathering of data on relevant related aspects health and safety at work in europe gender, jobs and working conditions in europe economic crises and mortality: a review of the literature employment status and health after privatisation in white collar civil servants: prospective cohort study globalization and labor conditions: working conditions and worker rights in a global economy consequences of modernity risk and responsibility human safety and risk management ageing, health and productivity: a challenge for the new millennium healthy work for older workers: work design and management factors individual behaviour and the control of danger management and culture: the third age of safety. a review of approaches to organizational aspects of safety, health and environment rr -projection of mesothelioma mortality in great britain industrial accident prevention: a scientific approach resilience: the challenge of the unstable safety i and safety ii: the past and future of safety management lessons from gretley: mindful leadership and the law monitoring new and emerging risks trends in quality of work in the netherlands implementing safety culture in a major multi-national challenges and perspectives of occupational health and safety research in nanotechnologies in nanotechnologies in europe the ageing workforce-challenges for occupational health protecting workplace safety and health in difficult economic times -the effect of the financial crisis and economic recession on occupational safety and health statutory occupational health and safety workplace arrangements for the modern labour market use of technology and working conditions in the european union aging, adult development, and work motivation globalization and workers' health health in restructuring: innovative approaches and policy recommendations ergonomics and technology transfer into small and medium sized enterprises new systems of work organization and workers' health work related and individual predictors for incident neck pain among office employees working with video display units perceptions of psychosocial hazards, work-related stress and workplace priority risks in developing countries safety considerations for the aging workforce happiness: lessons from a new science the european framework for psychosocial risk management (prima-ef) field theory in social science: selected theoretical papers women's occupational health in globalization and development unemployment and suicide. the lancet applying the biopsychosocial approach to managing risks of contemporary occupational health conditions: scoping review psychosocial stressors associated with mexican migrant farmworkers in the midwest united states women in africa's development: overcoming obstacles, pushing for progress career-relevant learning and development, worker age, and beliefs about selfefficacy for development one eyed science: occupational health and women workers age and working conditions in the european union the relation between work-related psychosocial factors and the development of depression occupational safety and health risk assessment methodologies ergonomics in industrially developing countries: does its application differ from that in industrially advanced countries? globalization and emerging economies. paris: organization for economic co-operation and development. organization for economic co-operation and development a good life in old age? monitoring and improving quality in long-term care. paris: organization for economic co-operation and development convergence and divergence of working conditions in europe building healthy and equitable workplaces for women and men: a resource for employers and workers representatives workers' compensation and the challenges posed by changing patterns of work: evidence from australia. policy and practice in health and safety the global expansion of precarious employment, work disorganization, and consequences for occupational health: a review of recent research managing the risks of organizational accidents women's employment in europe: trends and prospects aging, job performance, and career development the changing organization of work and the safety and health of working people: knowledge gaps and research directions exploring teacher and school resilience as a new perspective to solve persistent problems in the educational sector -a case of the netherlands. teachers and teaching: theory and practice considerations for incorporating "well-being" in public policy for workers and workplaces well-being at work -overview and perspective employee health and presenteeism: a systematic review positive psychology: an introduction the labour market outcomes and psychological well-being of ethnic minority migrants in britain. london: home office a multilevel analysis of organizational factors related to the taking of safety initiatives by work groups age differences in safety attitudes and safety performance in hong kong construction workers prognostic factors for duration of sick leave in patients sick listed with acute low back pain: a systematic review of the literature no security: a meta-analysis and review of job insecurity and its consequences globalization of risks organization development from a scandinavian point of view. doct. / some social and psychological consequences of the longwall method of coal-getting correlates of adult participation in physical activity: review and update occupational sitting and health risks: a systematic review temporary employment and health: a review the gender workplace health gap in europe predicting long-term incapacity for work: the case of low back pain is work good for your health and well-being? london: the stationery office differences among demographic groups and implications for the quality of working life and work satisfaction age and job performance managing the unexpected managing the unexpected biopsychosocial medicine: an integrated approach to understanding illness science, synthesis, and sanity: an inquiry into the nature of living lean thinking: banish waste and create wealth in your corporation global population ageing: peril or promise? preamble to the constitution of the world health organization. official records of the world health organization, , . world health organization (who) raising awareness of stress at work in developing countries: a modern hazard in a traditional working environment: advice to employers and worker representatives world health organization (who) sedentary behaviours and epithelial ovarian cancer risk key: cord- -v syiwie authors: rotz, lisa d.; layton, marcelle title: case study – united states of america date: - - journal: biopreparedness and public health doi: . / - - - - _ sha: doc_id: cord_uid: v syiwie the united states (us) considers the intentional use of a biological agent a serious national security threat. over the last decade, federal, state, and local governments in the us have made concerted efforts to enhance preparedness within the public health, medical, and emergency response systems to address this threat. these activities span a wide range of areas from the enactment of new legal authorities and legislative changes to significant financial investments to enhance multiple detection and response system capabilities and the adoption of a national command and control structure for response. many of these investments, although prompted by the concern for bioterrorism, have served to strengthen public health, medical, and emergency response systems overall and have proven invaluable in responses to other large-scale emergencies, such as the h n influenza pandemic. the intentional use of a biological agent is also something that the united states considers a serious threat and the federal, state, and local governments in the us have made concerted efforts to enhance preparedness and capabilities within the public health, medical, and emergency response systems to address this threat. in , this concern became a reality for the us when several letters containing anthrax spores were sent through the postal system to individuals and organizations [ ] . this resulted in cases of anthrax ( inhalational and cutaneous) with fi ve deaths. although this event may not have been the type of "mass-casualty" situation most bioterrorism preparedness planning activities were targeting, it still resulted in signi fi cant response efforts and cost; over , individuals were offered antibiotic prophylaxis because of possible exposures, over one million clinical and environmental specimens were tested, and hundreds of millions of dollars were spent on decontamination of the buildings where the letters were processed or opened [ , ] . although many infectious agents are capable of causing human illness, some are much more capable of causing signi fi cant morbidity and mortality if successfully used as a bioterrorism agent. in , the centers for disease control and prevention (cdc) developed a process to prioritize biological threat agents based on evaluation of the following threat agent characteristics: ( ) public health impact from ability to cause illness or death, ( ) ability to be produced and delivered in a way that could expose a large number of people, ( ) existing public perceptions of a biological agent that could contribute to heightened fear and panic, and ( ) requires signi fi cant special preparedness efforts in order to diagnose, treat, or prevent illness [ ] . based on these characteristics, biological threat agents were prioritized into three different tiers. category a (highest threat tier) included bacillus anthracis (anthrax), variola virus (smallpox), yersinia pestis (plague), francisella tularensis (tularemia), clostridium botulinum toxin (botulism), and the filo and arenaviruses (e.g., ebola and marburg virus) that cause viral hemorrhagic fevers. category b and c were lower threat tiers and included agents such as burkholderia mallei and b. pseudomallei , rickettsia prowasekii (category b), and emerging threats such as nipah virus (category c). following the release of homeland security presidential directive (hspd- ) in april , the us department of homeland security (dhs) became responsible for issuing biannual assessments of biological threats in order to guide the prioritization of ongoing investments in research, development, planning, and preparedness [ ] . the united states has made signi fi cant investments in terrorism preparedness and response coordination over the last two decades that includes the implementation of new policies, legislation, and legal authorities in addition to signi fi cant funding investments. in , presidential directive added a terrorism annex to the federal response plan and de fi ned responsibilities of federal agencies in responding to terrorism [ ] . the homeland security act of established the department of homeland security (dhs), a new cabinet level of fi ce whose primary mission is to prevent or reduce vulnerability of the united states to terrorism at home; coordinate homeland security responsibilities between the federal government and state, local and private entities; and minimize damage resulting from attacks and assist in the recovery. in , homeland security presidential directive (hspd- ) established a nationwide system to coordinate responses to emergencies between local, state, and federal governments and responding organizations and to administer this all hazards national response plan through a national incident management system (nims) that provides for uni fi ed command and better multi-agency coordination [ ] . other presidential directives and legislation enacted in the us since the world trade center and anthrax letter events in have provided stronger legal frameworks and public health capacity to prevent, prepare, and respond to intentional acts of biological terrorism. the public health security and bioterrorism preparedness response act (phsbpra) established new requirements for possession, use, and transfer of selected biological agents and toxins (select agent list) that could pose threats to human, animal, and plant health and safety as well as established other authorizations and appropriations necessary to carry out essential public health and medical preparedness and response activities [ ] . this act authorized more than . billion us dollars in grants to state and local governments and healthcare facilities to improve planning, training, detection, and response capacity as well as funding to expand the federal strategic national stockpile of medications and vaccines and upgrade food inspection capacity and cdc facilities that deal with public health threats. the project bioshield act (july ) and pandemic and all-hazards preparedness act (december ) also speci fi cally provided for new authorities and funding to address signi fi cant gaps that existed for the development, acquisition, and utilization of medical countermeasures (e.g. antimicrobials, vaccines, chemical antidotes) for chemical, biological, radiological, and nuclear (cbrn) threats. in , the cdc asked the center for law and public health at georgetown and johns hopkins universities to draft a model state public health law (the model state emergency health powers act or model act) for state and local jurisdictions to use in addressing either bioterrorism or naturally occurring disease outbreaks [ ] . the model act (available at http://www.publichealthlaw.net/msehpa/msehpa. pdf ) outlines fi ve major public health functions to be allowed by law including preparedness, surveillance, management of property, protection of persons, and communication. in addition to ensuring suf fi cient authority to collect disease surveillance data, conduct contact tracing, and provide preventive measures to those at risk, public health laws must enable local health of fi cials to implement quarantine measures, if needed, to control a contagious disease outbreak with epidemic potential that could lead to severe morbidity or mortality (e.g. smallpox). this authority should be linked with speci fi c, scienti fi cally appropriate criteria that would be met before quarantine could be implemented. in addition, public health laws should provide for due process measures to protect those affected. ideally, quarantine strategies would be determined and operational procedures would be in place prior to an emergency. ongoing broad-based investments to improve response planning and coordination, surveillance, training, information systems, and communications have been made that serve to improve public health capacity for all threats and hazards. starting in , the us government began providing funding to state, local, and territorial health departments to build stronger capacity for surveillance and epidemiology, laboratory diagnostic capacity, communications, countermeasure distribution, and emergency response planning, exercise, and evaluation. the initial investment into these public health system upgrades started at million us dollars per year with a primary focus on addressing bioterrorism threats. following the events of , funding to support enhancements in the national public health infrastructure increased to approximately . billion per year. the current state of progress towards speci fi c preparedness goals identi fi ed for cdc funded preparedness and response activities in the state, local, and us insular areas is provided in the " report -public health preparedness: strengthening the nation's emergency response state by state" which can be found online at http://emergency.cdc.gov/ publications/ phprep/ . additionally, more targeted investments have been made that address surveillance, detection, and illness prevention or treatment needs for speci fi c high priority threats. examples of these targeted initiatives include the laboratory response network (lrn), the strategic national stockpile (sns), and an environmental monitoring system called biowatch. in , the cdc and other partners formed the laboratory response network (lrn) [ ] . the lrn is a network of approximately national and international public health, veterinary, agriculture, food, military, and environmental laboratories that have increased diagnostic capability for the rapid identi fi cation of multiple biological and chemical threat agents in multiple sample types. participation in the network is voluntary and these pre-existing laboratories work under a single operational plan and adhere to policies on safety, security, and bio-containment. lrn members agree to perform testing using lrn procedures and are provided training, equipment, rapid detection assays and reagents, protocols, and secured communication and data reporting systems to increase testing and laboratory response capabilities in a standardized and coordinated fashion. there are three types of laboratory designation within the lrn: national, reference, and sentinel. national labs have unique capabilities and resources that allow them to handle highly infectious agents and perform strain-level identi fi cation and other agent characterization testing. reference laboratories are mostly based at state and large city health departments and have the capability to perform rapid con fi rmatory testing for certain agents and toxins while sentinel laboratories (primarily hospital and commercial clinical laboratories) can perform routine clinical testing on patient specimens with additional training and protocols for noti fi cation and rapid referral of isolates in the event that they are unable to rule-out a biothreat agent. in addition to the central role the lrn played in detecting and responding to the anthrax letter event, the commitment to infrastructure support and standardized platform testing capacity within the lrn has also proven extremely bene fi cial in assisting with more rapid and broader deployment of tests developed in response to other emerging public health threats such as the severe acute respiratory syndrome (sars) and the h n avian in fl uenza pandemic. lrn laboratories are also trained on chain-of-custody requirements and protocols which allow them to serve as a local testing resource for law enforcement linked samples where there is a concern for biological threat agents. approximately % of the us population lives within miles of an lrn laboratory, which provides for more rapid access to con fi rmatory diagnostic testing to evaluate potential illness from or exposures to threat agents. the sns (formerly the national pharmaceutical stockpile) program began in to acquire and store a stockpile of medications, vaccines, and other medical supplies whose rapid availability is vitally important for response to a large-scale event involving certain biological, chemical, or radiological agents [ ] . without a pre-purchased and stored stockpile, most of these medications and vaccines would not be readily available through other sources in appropriate amounts or in a timeframe that would allow for the prevention or effective treatment of illness. partnerships with storage and transportation companies have been created that provide strategically located storage facilities, allowing rapid delivery of sns materiel to any location in the us or its territories within h of the federal decision to deploy. certain medical countermeasures may be eligible for the shelf-life extension program managed by the food and drug administration and the department of defense, which allows for expiration date extension based on potency and other test results. in addition, agreements with pharmaceutical companies and medication distribution partners have allowed for rotation of certain medications back into the commercial supply chain for use prior to their expiration in order to help mitigate replacement costs. although the sns was originally developed as a medical countermeasure response resource for intentional biological, chemical, and radiological emergencies, it has been deployed and used multiple times to support the medical needs of other public health emergencies, including hurricanes katrina and rita, the recent h n in fl uenza pandemic, the world trade center and the anthrax letter attacks. the successful distribution of the sns is dependent on the capacity of state and local jurisdictions to rapidly dispense these countermeasures to the public. planning for the timely provision of antibiotics and/or vaccines to large populations requires the involvement of public health, emergency management, and the local medical community. mass prophylaxis plans need to consider the speci fi c challenges of potentially vulnerable populations, such as children, pregnant women, and those who are isolated and without resources and social supports, such as the homeless and homebound. contingency plans for setting up community-based points of dispensing (pods) for mass prophylaxis have been developed by most state and local jurisdictions, with a focus on ensuring suf fi cient staf fi ng resources, equipment and space requirements, and expediting patient fl ow. the capacity of health of fi cials to rapidly vaccinate the community was recently tested in the united states during the h n pandemic and demonstrated the need for fl exibility and coordination in distribution of vaccine, including school-based programs, community health centers, pharmacies, and large health department sponsored vaccination clinics. multiple initiatives have been supported to further strengthen public health disease surveillance and reporting that include an emphasis on traditional disease reporting as well as the utilization of non-traditional data that may provide an earlier indication of community health events or more likely assist with situational awareness assessments during an identi fi ed event [ ] . traditional public health surveillance for illness associated with potential bioterrorism agents relies on enhancing the medical and laboratory communities' familiarity with these agents, with the goal of improved reporting of suspected or con fi rmed illnesses, as well as reporting of unusual disease manifestations or illness clusters. most local and state health codes require that physicians, hospitals, and laboratories report a de fi ned list of noti fi able infectious diseases. state public health agencies have added cdc category a and b agents to their reportable disease lists. these lists are available at http:// www.cste.org/dnn/programs andactivities/publichealthinformatics/phistate reportablewebsites/tabid/ /default.aspx. in addition, recognizing the need to detect newly emergent diseases that are not yet listed on the health code, most states also require reporting of any unusual disease clusters or manifestations. early recognition of a bioterrorism-associated event depends in large part on astute clinicians and laboratorians recognizing one of the index cases based on a suspicious clinical, radiologic, or laboratory presentation (e.g. a febrile illness associated with chest discomfort and a widened mediastinum on chest radiograph in an otherwise healthy adult suggests inhalation anthrax). isolated cases presenting at separate hospitals will not be recognized as a potential outbreak unless they are reported promptly to the local health department, where the population-based aberrations in disease trends are more likely to be noticed. previous examples of astute clinicians recognizing and reporting unusual disease clusters or manifestations that led to the detection of a more widespread outbreak include an outbreak of hantavirus in the southwestern us [ ] , legionnaires' disease associated with the whirlpool on a cruise ship [ ] , an outbreak of cyclospora associated with contaminated raspberries imported from guatemala [ ] , and the initial outbreak of west nile virus in new york city in [ ] . similarly, the initial detection of anthrax in was due to a physician who recognized that large gram-positive rods in a patient's cerebrospinal fl uid could be b. anthracis [ ] . by reporting this suspected case of meningeal anthrax, rapid con fi rmation was facilitated in a state public health lrn reference laboratory. weeks later, a suspected case of inhalation anthrax was recognized and promptly reported to and con fi rmed by public health authorities in new york city [ ] . with the continued emergence of new zoonotic disease threats, including those related to bioterrorism, local, state, and federal public health agencies have taken steps to improve communication between human and animal health communities. noti fi able disease requirements have been expanded to include reporting by animal health specialists of suspected or con fi rmed illness in an animal that might be caused by a potential biothreat agent. because many medical providers and laboratorians in the united states have limited experience with most potential bioterrorist agents, early diagnosis may be delayed. therefore, the fi rst indication that a large-scale bioterrorist attack has taken place might be an increase in nonspeci fi c symptoms at the community level. surveillance for these increases in nonspeci fi c syndromes (e.g. respiratory, gastrointestinal, or neurologic) constitutes the cornerstone of syndromic surveillance used for emergency response purposes. many health jurisdictions have begun collecting and monitoring other types of health-related information such as symptom complexes presented during emergency room visits (e.g. lower respiratory tract illness, gastrointestinal illness, rash with fever), healthcare utilization information (e.g. emergency room visits, calls), or other data that may be affected by a community-wide health event (e.g. school absenteeism, fl u or diarrhea over-the-counter medication sales) [ , ] . though the approaches and cost for implementing syndromic surveillance vary, the tools and concepts for syndromic surveillance are adaptable and have been successfully implemented in both developed and developing countries to address routine surveillance, outbreak monitoring, and health security needs [ ] . while initially conceived for early detection for bioterrorism, these systems also can be used to monitor natural infectious disease outbreaks and trends in noninfectious events of public health importance. information from syndromic systems has proven to be useful for detecting, monitoring, and characterizing seasonal outbreaks of in fl uenza, winter gastroenteritis (e.g. norovirus and rotavirus) and asthma. furthermore, syndromic systems were utilized extensively in the us during the novel h n in fl uenza pandemic of , along with other methods, to estimate the scale of community-wide in fl uenza transmission. an additional concept to speci fi cally improve early detection of an intentional biological agent release is the use of environmental monitoring systems. if an agent can be detected quickly following an aerosol release, response timelines can be signi fi cantly improved, allowing for more time to intervene and potentially prevent illness in a signi fi cant portion of the exposed population. in , the united states implemented biowatch, an environmental monitoring system that consists of a network of samplers that collect air on a continuing cycle [ ] . filters from the monitors are removed on a frequent basis and screened in a laboratory for the presence of several biological threat agents. biowatch is currently operational in multiple us cities. environmental monitoring in this fashion requires a signi fi cant fi nancial commitment and is a complex system to operate as experience with this type of system was limited prior to its implementation. natural environmental presence of the target organisms and/or very closely related organisms and the size of the area to be monitored present ongoing challenges for establishing system sensitivities and speci fi cities that appropriately balance the potential value of early detection of a bioterrorism attack with the risk of inappropriately responding to a positive test that is caused by naturally occurring organisms in the environment. a separate system of detectors has also been deployed that monitors the us mail system, the method of "dissemination" used in the anthrax letter attacks. the us postal biohazard detection system (bds) has been operational since [ ] . unlike traditional disease and syndromic surveillance systems for human and animal health which monitor for both intentional and naturally occurring disease, these environmental systems are single purpose with the primary focus being early warning of bioterrorism. one of the more effective preparedness planning tools are tabletop and fi eld exercises, with involvement of representatives from key local, state, and federal agencies, as well as representatives from the local medical and laboratory communities. these exercises provide the opportunity to test assumptions in existing plans, and work out issues related to decision-making authority and respective roles and responsibilities among the various disciplines that would be involved in responding to a bioterrorist attack or other local emergency. post exercise debrie fi ngs should be conducted to highlight gaps in preparedness that can then be addressed through follow-up planning meetings and revision of written plans, if indicated, and re-evaluated with repeat exercises. depending upon the size and scope, responses to public health emergencies may involve resources and responsibilities that span multiple agencies at the local (city or county), state, and federal government levels. emergency events begin at the community level (single or multiple communities) and local personnel and resources (medical, public health, emergency services, police, fi re, etc.) provide the initial response. if local resources are overwhelmed or authorities require special assistance or resources that are not locally available, assistance from the state or federal level can be requested. this may be done through a direct assistance request to an agency or agencies (e.g. a request to cdc to assist with a food outbreak investigation or test samples) or through the formal declaration of an emergency that activates state and federal emergency support functions (e.g. declaration of state of emergency that activates the federal emergency management agency (fema) and other federal assistance as needed through the national response framework (nrf) and the associated emergency support functions (esf)). emergency responses and their coordination in the us primarily involve civilian agencies and authorities, with the military providing support as needed. central to the ability to successfully coordinate a response to a large-scale emergency is the ability to integrate information fl ow, resources, and personnel into an organizational structure that is similar across all responding agencies, whether the emergency is primarily public health in nature or due to some other cause. this incident management system or incident command system (ics) structure, has been used for many years by traditional fi rst responder agencies such as fi re and law enforcement and was formally identi fi ed as the national emergency response structure in [ ] . ics has also been adopted and used to a much greater extent by federal, state, and local public health agencies responding to public health emergencies. cdc utilized the ics to coordinate its response to public health emergencies such as the h n pandemic and multi-state foodborne outbreaks but has also bene fi ted from better integration of its response activities into larger-scale, multi-hazard emergency responses such as hurricane katrina and the recent haiti earthquake. the us department of health and human services (dhhs) has the lead for coordinating the federal public health and medical services support functions outlined in esf ( http://www.fema.gov/pdf/emergency/nrf/nrf-esf- .pdf ). these support functions include response activities in the following areas: ( ) assessment of public health/medical needs, ( ) health surveillance, ( ) medical care personnel, ( ) health/medical/veterinary equipment and supplies, ( ) patient evacuation, ( ) patient care, ( ) safety and security of drugs, biologics, and medical devices, ( ) blood and blood products, ( ) food safety and security, ( ) agriculture safety and security, ( ) all-hazard public health and medical consultation, technical assistance, and support, ( ) behavioral health care, ( ) public health and medical information, ( ) vector control, ( ) potable water/wastewater and solid waste disposal, ( ) mass fatality management, victim identi fi cation, and decontaminating remains, and ( ) veterinary medical support. several agencies exist within dhhs that help carry out these activities, including cdc, the food and drug administration (fda), the national institutes for health (nih), and the substance abuse and mental health services administration (samhsa) among others. in addition, dhhs manages the national disaster medical system (ndms) which includes disaster medical, surgical, and mortuary response teams as well as veterinary response teams. in addition to providing medical response to a disaster area, ndms also coordinates patient movement into hospital care in unaffected areas for de fi nitive medical care with the support of the department of defense (dod). in addition to dod, multiple other agencies and departments provide support to dhhs for esf functions, including the department of agriculture (doa), dhs, fema, the department of transportation (dot), the department of veterans affairs (va), the american red cross (arc), and others. once a bioterrorist event is recognized and then con fi rmed by laboratory testing, there will be a need for large-scale mobilization of surveillance and epidemiologic investigations. the focus of these investigations will be ( ) tracking the number of cases to de fi ne the scope of the incident and ( ) performing epidemiologic investigations to determine the common source(s) and site(s) of exposure. this information will be most critical in the event of a covert bioterrorist event to determine where and when the attack occurred, and who else may have been potentially exposed (either at the event or due to downwind distribution of the aerosol) and thus require prophylaxis. as active surveillance would need to be initiated rapidly once a bioterrorist event is recognized, many local and state health departments have developed materials and plans to facilitate the ability to rapidly implement an investigation, including template surveillance instruments and protocols for urgently mobilizing and deploying active surveillance surge teams to hospitals in the affected area. response to public health emergencies that result from an intentional biothreat agent, such as the us anthrax letter attacks, have an added investigational and coordination complexity due to the necessary law enforcement component of the event [ ] . if an event is known to be secondary to an intentional act, local law enforcement of fi cials and the federal bureau of investigation (fbi) have a greater leadership role in coordinating the investigation and communication, however, public health and other responding entities are still responsible for carrying out their usual surveillance and emergency response activities. in this scenario, activities such as interviewing victims to determine the common site and/or sources of exposure, specimen or sample collection and testing, and public messaging would be coordinated with the fbi or other law enforcement of fi cials in order to preserve evidence and investigative information that may be essential for attribution and conviction of the perpetrators. some activities such as sample collection or victim interviews may even need to be planned and conducted jointly by public health and law enforcement of fi cials. although law enforcement has the responsibility for conducting the criminal investigation, their primary mission is also the preservation of life and health and investigative activities are targeted towards accomplishing that goal in addition to obtaining the evidence needed to identify and convict those responsible. many local, state, and federal public health and law enforcement authorities in the us have recognized the investigation and communication coordination that would be required in a bioterrorism or other intentional chemical, radiological, or toxin induced event that affects the health of individuals or communities and have established working relationships for preparedness as well as formalized agreements for information sharing and joint investigative activities in this type of event. a model for a memorandum of understanding (mou) that can be used to create formalized working agreements between public health and law enforcement of fi cials was developed by a working group convened by the cdc and the us department of justice. this model mou has been distributed to state and local authorities and a copy can be requested through the cdc public health law practice website at http://www a. cdc.gov/phlp/mounote.asp . the united states considers bioterrorism a serious threat to its national security and has made concerted efforts over the last decade to bolster public health and other response capacity capabilities. many of these efforts, though initially begun to address the needs for bioterrorism preparedness, have proven bene fi cial for public health in responding to other emergencies, including those due to naturally occurring disease threats such as pandemic in fl uenza. speci fi cally, efforts that focused on improving: ( ) laboratory diagnostic capacity, ( ) surveillance data sources, analysis, and reporting, ( ) risk communication ( ) emergency response planning and training, and ( ) overall response coordination have proven extremely bene fi cial for supporting public health responses to all types of health threats. in most state and local health departments in the us, bioterrorism surveillance and response capacity is fully integrated into the general infectious disease and all hazards emergency response infrastructure. the same staff that surveil for and respond to both routine and emergency infectious disease outbreaks would be called upon to respond to a bioterrorism attack. this dual-use capacity is more ef fi cient and ensures that front line public health staff maintain and exercise the skills required to detect and respond to disease threats, regardless of whether intentional or natural. the h n pandemic provided one of the best training opportunities for what might be encountered in the event of a large scale bioterrorist outbreak, including the need to implement enhanced surveillance to provide greater real time situational awareness, with the initial reliance on the public health laboratory system for reference testing, and the implementation of a large scale vaccination campaign. although bioterrorism is not accorded the same level of concern everywhere, investments that help build or support stronger public health and medical systems provide the foundation for responding to all health threats and are essential, should an unthinkable event such as a large-scale bioterrorism attack occur. index case of fatal inhalational anthrax due to bioterrorism in the united states collaboration between public health and law enforcement: new paradigms and partnerships for bioterrorism planning and response emergency preparedness and response: the laboratory response network partners in preparedness emergency preparedness and response: strategic national stockpile leading causes of death syndromic surveillance: adapting innovations to developing settings hantavirus pulmonary syndrome: a clinical description of patients with a newly recognized disease encyclopedia of quantitative risk analysis and assessment the model state emergency health powers act: planning for and response to bioterrorism and naturally occurring infectious diseases overview of syndromic surveillance: what is syndromic surveillance an outbreak in of cyclosporiasis associated with imported raspberries anthrax bioterrorism: lessons learned and future directions outbreak of legionnaires' disease among cruise ship passengers exposed to a contaminated whirlpool spa investigation of bioterrorism-related anthrax implementing syndromic surveillance: a practical guide informed by the early experience responding to detection of aerosolized bacillus anthracis by autonomous detection systems in the workplace fatal inhalational anthrax with unknown source of exposure in a -year-old woman in new york city the outbreak of west nile virus infection in the new york city area in the public health security and bioterrorism preparedness and response act public health assessment of potential biological terrorism agents the biowatch program: detection of bioterrorism antimicrobial postexposure prophylaxis for anthrax: adverse events and adherence hspd- : biodefense for the st century hspd- : management of domestic incidents terrorism incident annex to the federal response plan key: cord- - su uan authors: lynteris, christos title: introduction: infectious animals and epidemic blame date: - - journal: framing animals as epidemic villains doi: . / - - - - _ sha: doc_id: cord_uid: su uan the introduction to the edited volume summarises the chapters of the volume and discusses their contribution in the context of current historical and anthropological studies of zoonotic and vector-borne disease, with a particular focus on how epidemic blame is articulated in different historical, social and political contexts. of 'emerging infectious diseases' (eid), which configures the rise of new diseases as carrying with it a potential for human extinction. this volume examines the history of the emergence and transformation of epidemiological and public health framings of non-human disease vectors and hosts across the globe. providing original studies of rats, mosquitoes, marmots, dogs and 'bushmeat', which at different points in the history of modern medicine and public health have come to embody social and scientific concerns about infection, this volume aims to elucidate the impact of framing non-human animals as epidemic villains. underlining the ethical, aesthetic, epistemological and political entanglement of non-human animals with shifting medical perspectives and agendas, ranging from tropical medicine to global health, the chapters in this volume come to remind us that, in spite of the rhetoric of one health and academic evocations of multispecies intimacies, the image and social life of non-human animals as epidemic villains is a constitutive part of modern epidemiology and public health as apparatuses of state and capitalist management. whereas the above approaches (including microbiome studies, and 'entanglement' frameworks in medical anthropology) do contribute to a much-needed shift in the intellectual landscape as regards the impact of animals on human health, their practical and political limitations are revealed each time there is an actual epidemic crisis. then, all talk of one health, multispecies relationships and partnerships melts into thin air, and what is swiftly put in place, to protect humanity from zoonotic or vector-borne diseases, is an apparatus of culling, stamping out, disinfection, disinfestation, separation and eradication; what we may call the sovereign heart of public health in relation to animal-borne diseases. for the maintenance and operation of this militarised apparatus, the framing of specific animals as epidemic villains is ideologically and biopolitically indispensable, even when blame of the 'villain' in question lacks conclusive scientific evidence (see thys, this volume). going against the grain of scholarship that in recent years has sought to portray the vilification of animals as hosts and spreaders of disease as a thing of the past, histories of non-human disease hosts and vectors aims to illuminate the continuous importance of this ideological and biopolitical cornerstone of modern epidemiology and public health. representations of animals as enemies, antagonists or sources of danger have, in different forms, shapes and degrees, been part and parcel of human interactions with the non-human world across history. it is, however, only at the turn of the nineteenth century that, as a result of bacteriological breakthroughs, non-human animals began to be systematically identified and framed as reservoirs and spreaders of diseases affecting humans. to take one famous example, before the end of the nineteenth century, rats were not believed to be carriers or spreaders of plague or any other infectious disease. whereas rats had long been considered to be damaging to human livelihood, due to consuming and spoiling food resources, their only redeeming characteristic was, erroneously, widely believed to be their supposed disease-free nature. hence while mid-seventeenth-century plague treatises noted the rat's destructive impact on fabrics and food, no mention of its connection with the disease was made. equally, two centuries later, when in - british colonial officers in india observed that, at the first sight of rat epizootics, garhwali villagers fled to the himalayan foothills in fear of the 'mahamari' disease, they dismissed this behaviour as merely superstitious. however, the bacteriological identification of rats as carriers of plague or mosquitoes as carriers and spreaders of yellow fever and malaria, at the end of the nineteenth century, was itself enabled and indeed complicated by an already-existing stratum of signification which, by the mid-seventeenth century, had led to the introduction of new symbolic, ontological and legal frameworks of thinking about animals as 'vermin'. vermin, in mary fissell's definition, 'are animals whom it is largely acceptable to kill', not because of some inherent characteristic they possess, but because, in specific historical contexts, 'they called into question some of the social relations which humans had built around themselves and animals'. paraphrasing fissell, we may say that, arising in early modern europe, the category 'vermin' problematised animals which devoured or destroyed the products of human labour and the means of human subsistence in terms of an agency or intentionality that confounded human efforts to control them. departing from the structuralist influences of mary douglas, which dominated animal studies in the s (see, for example, robert danton's work on the great cat massacre in france), and from keith thomas' 'modernisation' reading of vermin as simply animals that were of no use in an increasingly utilitarian world, fissell's discourse analysis of popular texts on vermin from seventeenth-century england was the first to dwell in the social historical reality of the emergence of this notion. however, more recent studies have opposed fissell's idea that what made vermin a threat to 'human civility' was their perceived 'greed and cunning', or their overall 'trickster' character. lucinda cole's recent monograph imperfect creatures argues that, 'what made vermin dangerous was less their breedspecific cleverness or greed than their prodigious powers of reproduction through which individual appetites took on new, collective power, especially in relation to uncertain food supplies'. the two approaches are not mutually exclusive. indeed, if approached anthropologically, they point to an entanglement between symbolic and economic aspects of vermin as threats to 'social integrity', something that is further supported by the association of vermin at the time with vagrancy and the poor. medical historians have in turn noted the association of vermin with miasma in disease aetiologies and public health practices of early modern europe, especially in times of epidemics when extensive legislation against them and prescriptions for their destruction are recorded. this was particularly the case in the context of plague outbreaks that had long been associated with 'putrid' and 'corrupt' vapours, which certain animals, like dogs, pigs, cats and poultry (and their excrements and carcasses), were believed to emanate. as in the late middle ages, the fear of pestilential miasmata emanating from offal and other meat products had led to the spatial regulation of butchery in england and other parts of europe (cf concerns with 'bushmeat' in relation to ebola; thys, this volume), william riguelle has shown that, in the course of the seventeenth century, concerns with 'noxious' animals played an important role in instituting limits of where these could be kept and where they could be allowed to roam in urban environments. the idea of miasma would continue to impact medical thinking into the nineteenth century. as a part of ontologies that escape both the straightjacket of recent anthropological classifications and classical medicalhistorical dichotomies of contagionism/anti-contagionism, the idea of miasma was malleable, adaptable and ambiguous enough to be compatible with, rather than antagonistic to, that of infection and contagion. however, as new medical and biopolitical challenges arose in the context of colonial conquest, the problematisation of animal-derived miasma or 'febrile poison' gave way to concerns about the climate as the driving force of epidemic disease. thus while the dawn of bacteriology, by the s, did not introduce understandings of animals as sources of disease ex nihilo, it did mark a drastic return to this idea, and, at the same time, led to a significant conceptual shift as regards the ontology of the diseases transmitted, and the mechanism involved in this transmission. this transformation was catalysed by an intense medical, economic and political interest and concern over cattle epizootics, which, as historians have shown, catalysed both the emergence of veterinary medicine and the medicalisation of animals across the globe in the second half of the century. as regards infectious diseases affecting humans, the medicalisation of non-human animals and their transformation into 'epidemic villains' involved an interlinked, two-part framing of their epidemiological significance: on the one hand, as spreaders and, on the other hand, as reservoirs of diseases. the historiography of the identification and study of non-human animals as spreaders of infectious diseases has for some time now stopped being the foray of heroic biographies of men like ronald ross, paul-louis simond or carlos chagas. focused on the social, political and epistemological histories of scientific studies of zoonosis and vector-borne diseases, historians, anthropologists and sts scholars have underlined the ways in which, within epidemiology, bacteriology and parasitology, non-human animals constituted active agents in complex networks of power and knowledge, and how they assumed different epistemic value in diverse colonial and metropolitan contexts. framed as spreaders of infectious diseases, animals also came to play an important role in what charles rosenberg has famously described as the dramaturgy of epidemics. assuming a protagonistic role in a series of epidemic and public health dramas, animals came to be seen as the ultimate source of disease outbreaks. no longer simply a nuisance or 'pests', the transformed image of a series of animals (mosquitos, rats, ticks, lice and flies in particular) as enemies of humanity was invested with militaristic tropes and colonial moralities. these animals formed as it were a global repertoire of disease spreaders, while at the same time assuming importantly diverse local forms, often in interaction with concerns and social imaginaries about other, regionally specific, disease hosts and vectors (beetles, bats, sandflies, etc.). while it is not in the scope of this introduction to map these 'glocal' interactions, deborah nadal's chapter in this volume provides a detailed picture of the longue durée of dogs as spreaders of rabies in india. nadal's chapter underlines the complex and important semiotic and ontological workings and re-workings on dogs as spreaders of rabies from colonial india to our times. with dog-borne rabies being recognised as an important public health problem across the globe since the s, in india, where rabies is endemic, human understandings of the particular zoonosis were linked to practices of classifying dogs. for british colonials, distinguishing between rabies-prone and rabies-impervious dogs was key to the imperial project of mastery over both indian society and 'nature'. within the confines of tropical medicine and its biopolitical imperatives, the management of rabies made crucial the definition of dog-human relations in terms of ownership. believed to be able to spontaneously develop rabies, for the british, 'ownerless' dogs presented a distinct danger for the colony. seen as the source of infection amongst owned dogs (which were considered unable to develop spontaneous rabies), these animals, nadal argues, challenged victorian morality and were associated with two key notions: on the one hand the notion of 'stray', with its overtones of vagrancy, and, on the other hand, the notion of the 'pariah'-an anglicised caste term used by british colonials to refer to outcaste or untouchable communities. at the heart of these classifications lied ideas about domesticity and wildness, as well as a pervasive social hierarchical mentality. perceiving street life in general as a threat to colonial rule grouped dogs of distinct social status and social life under one, infectious category. transforming 'strays' from 'vermin' and 'nuisance' into epidemic villains that should be sacrificed in the name of human health was not, however, a frictionless process but, as nadal shows us, one that embroiled indian society in debates about the value of life and compassion (led by both anti-vivisectionists and mahatma gandhi). after , 'catch-and-kill' of dogs for the control of rabies continued unabated but also involved indian society in renewed debate involving civil society activists, animal welfarists and political parties. in nadal's reading, these dog-related conflicts underlined a lingering problem pertaining to the classification of dogs vis-à-vis rabies: the persistence of the term 'stray' (inclusive of its 'pariah' associations). the solution since , nadal argues, has been the emergence of a discourse around 'street dogs', which has marked a shift towards an accommodation between different attitudes towards the particular animals, allowing for the concept that they can be both masterless and hygienic. nadal's chapter thus points out that, at the same time as what we may call high-epidemiology redefined experiences of non-human animals as spreaders of disease, it also instituted regimes of hygienic hope. envisioning and putting in place programs of increasing separation between humans and non-human disease vectors became the hallmark of public health from onwards. whether this involved rat-proofing, ddt spraying, mosquito nets, the cleaning of streets from stray dogs or the drying of swamps, this sanitary-utopian aspiration to liberate humanity of zoonotic and vectorborne diseases was based on a vision of universal breaking of the 'chains of infection'; a separation and, at the same time, unshackling of humans from disease vectors that was aimed at confining pathogens in the animal realm. in this way, whereas separation from animals was seen as a sufficient means of protection of humans from zoonotic and vector-borne diseases, animals themselves were defined as ultimately hygienically unredeemable-they were, in other words, rendered indistinct from disease. hence, the naturalist ontology of the enlightenment, which in philippe descola's anthropological model defines humans and animals as unified under the rubric of nature, was unsettled by a radical divide that saw disease as a mode of being which was only inherently proper to non-human animals, and only tentatively, or, as sanitary utopians would have it, temporarily, part of the human species. sayer's chapter in this volume focuses on the - plague outbreak in freston (suffolk, uk)-the last outbreak of plague in the history of england-and excavates the epistemological, political, class and colonial history of such a regime of prevention and hope. analysing what she calls 'the vermin landscape' of the outbreak, sayer focuses on non-human animal actors so as to show that, in spite of the widespread epidemiological acceptance of the rat flea (xenopsylla cheopis ) as the true spreader of plague, ideas about locality and class created a medico-juridical matrix where it was the rat that constituted the main object of scientific investigation and public health intervention. situating the suffolk outbreak both within the third plague pandemic and within british imperial science politics, sayer stresses the ways in which suffolk was connected to india, as the prime locus of the pandemic and of plague science in the empire. as the outbreak in suffolk was experienced as an echo of the ongoing devastating epidemic in india, the rat became an object of epidemiological concern and fear. what if infected rats moved from the rural hotspots of the epidemic into urban areas, transforming them into the equivalents of plague-ravaged bombay on english soil? such fears were fostered not just by the perceived natural traits of rats (as invasive of migratory animals), but also through their association with the rural poor. tapping into complex imaginary registers involving victorian systems of class-related disgust, the english rural idyll, and the image of 'the labourer's country cottage […] as literal and figurative representation of the state of the nation', sayer argues that, 'because this rested in turn on the state of the rural labouring class, and that class were said here to be unsanitary and their cottages invaded by rat and plague, the indian racial other therefore ghosted a new category of (dead) undeserving poor'. as epidemic villains, in the eyes of epidemiologists and public health authorities, rats indianised the dwellings of rural labourers in suffolk. as 'plague was equated with "rat plague"', plague also became indian plague, and in turn necessitated control measures and legislation aimed at 'codif [ying] the rat in law and normalis[ing] its destruction'. formulated around an entanglement of class and interspecies relations, the suffolk plague crisis led, on the one hand, to an increasing medico-juridical investment of the rat in england, while, on the other hand, to a systematic neglect of 'the hares, cats, dogs that featured in gamekeepers' and labourers' narratives of the disease'. identifying and investing on a non-human epidemic protagonist (the rat) led to, and indeed required, a disinvestment and neglect of other species involved in the spread of the disease, and-perhaps most crucially-to overlooking the ecological complexity of disease persistence and transmission between different species in any given ecosystem. the rats and mice (destruction) act , 'which tasked every british citizen with a legal obligation to remove rats from their property', was the pinnacle of the configuration of the rat as an epidemic villain in england and of the institutionalisation of sanitary regimes of hope as regards the prevention of animal-borne infection. having conquered the globe by the mid- s, this regime of prevention and hope came to an end with the dawn of the emerging infectious diseases framework in the early s, when scientists began to focus on processes leading to new diseases, hitherto of non-human animals, infecting humans and to the 'specie-jump' processes (so-called spillover) leading to this phenomenon: 'rather than revolving around already-existing pathogens and how they circulate in specific ecological contexts, the focus on emergence required a shift of attention to what we may call "viral ontogenesis"'. over the past years, the rise of 'emergence' as the central framework of studying and understanding infectious diseases has led to a radical shift of scales and a reinvestment on zoonotic diseases that has been tied to a shift away from prevention towards preparedness. this is a regime of biosecurity that, as anthropologists like andrew lakoff, frédéric keck and carlo caduff have shown, is based on the anticipation of an unavoidable pandemic catastrophe, and which sets in place technologies of biosecurity that have come to increasingly dominate the realm of global health. envisioned as inevitable and catastrophic, 'emergence' has thus radically transformed the status of animals as epidemic villains. on the one hand, whereas in the sanitary-utopian framework of highepidemiology, animals were considered to be isolatable carriers of disease, in the eid framework infection is rendered inevitable. and, on the other hand, whereas for the sanitary-utopian framework, animal-human infection posed a limited threat to humanity, for eid it poses an unlimited one, or to be precise one associated with existential risk. it is telling that the mytho-historical event defining the conceptual horizon of the sanitaryutopian framework was the black death. believed by to have been rat-borne bubonic plague, the fourteenth-century pandemic was used by moderns as a key cautionary tale, and at the same time as a potent medical metaphor: black death was something that could 'return' (as hundreds of reports and news items made clear during the third plague pandemic) but whose impact would be effectively limited by grace of modern medicine and sanitation. on the other hand, as caduff has shown, the mytho-historical event defining the conceptual horizon of eid is the flu pandemic. the political ontology of this event for our contemporary pandemic imaginary is distinctly different from that of the black death for the early-tomid-twentieth-century public. for, as every contemporary epidemiological report and news broadcast makes clear, were an event like 'the spanish flu' to occur again today, globalisation and modern transport would transform it to an event of human extinction proportions; something not only nonpreventable, but whose control, once it has begun, is not guaranteed. both of these mytho-historical events have non-human animals at the heart of their causation narrative: the black death (at least so scientists believed at the time) rats, while the flu birds, probably chicken. however, while the sanitary myth of origin of the black death portrayed the rat as an ancient enemy of humanity whose days were numbered due to the advancement of science, the eid myth of origin frames chicken as just one example of a host of unknown species from which the 'killer virus' may emerge and against which the only action we can take is being prepared. séverine thys' chapter in this volume explores the consequences of the eid approach to non-human animals, as it applied to 'bushmeat' in the context of the recent ebola epidemic in west africa ( - ), with a focus on the impact of epidemiological and public health framings of 'bushmeat' hunting, butchering and consumption. especially affecting 'forest people' in macenta, guinea-conakry, the framing of a fluid host of animals as the source of epidemiologically illicit meat relies on persistent colonial tropes that imagine the 'tropical jungle' as an originally natural realm whose disturbance by human activity leads to the emergence of killer viruses. rehearsed time and again in films like outbreak ( ), this mortal link between nature and culture, thys reminds us, is currently being mediated by the figure of the bat-the in-between figure of a 'rogue' animal, which, james fairhead has shown, is being increasingly deployed as an epidemiological bridge in several zoonotic scenarios (ebola, mers, sars). thys follows other anthropologists in pointing out that this insistence on 'bushmeat' and contact with fruit-bats frames local cultures as pathogenic, in line with paul ewald's notion of 'culture vectors', and thus 'obscure[s] the actual, political, economic, and political-economic drivers of infectious disease patterns'. framed in terms of a 'transgression of species boundaries', ebola spillover events are thus pictured as resulting from a life led according to 'traditional' (and the implication is irrational) classificatory systems that fail to maintain 'us vs. them' boundaries. replete with visual and affective structures of disgust, this view, thys argues, is not challenged by the one health framework, which 'should provide a more nuanced and expanded account of the fluidity of bodies, categories and boundaries' so as to 'generate novel ways of addressing zoonotic diseases, which have closer integration with people's own cultural norms and understandings of human-animal dynamics'. key to this, according to thys, is to recognise and examine the historically dynamic nature of these classificatory and more broadly ontological systems (a view shared by nadal, this volume), and the explanatory models with which they are entangled. thys outlines the complex matrix of uses of non-farmed meat in the region (for nourishment, medicaments, trophies, etc.) and their transformation under the weight of regional and global commodity market networks. one may add that what is often neglected is the fact that 'bushmeat' was used by colonial authorities as a reward to local communities; in angola, for example, the portuguese rewarded local communities with 'bushmeat' for rat-catching in the colonial power's effort to contain plague during the s. the political investments of non-human animals as disease spreaders are further explored in gabriel lopes' and luísa reis-castro's chapter in this volume on the history of the aedes aegypti mosquito in modern brazil. following the social life of the particular mosquito species from the s until today, lopes and reis-castro stress that, while recognising that it has always constituted an 'epidemic villain', we need to pay closer attention to the particular diseases to which this villainous character has been linked to, and to the corresponding political system under which this identification has been undertaken, over the course of modern brazilian history. at the beginning of the twentieth century, aedes aegypti was associated with 'underdevelopment' as a key overarching ailment of brazil, with 'the image of a plagued country swarming with mosquitoes' filled with yellow fever playing an important role in bringing health under the rubric of the state and its modernising agenda. lopes and reis-castro follow gilberto hochman's classic work on the linkage between sanitation and nationbuilding in brazil in stressing that what began as a project of 'civilizing the tropics' by eliminating yellow fever across the country transformed by the early s into a more modest programme of preventing outbreaks in urban centres. by contrast to the liberal nation-building sanitary-utopian visions of oswaldo cruz and his collaborators in the first decades of the twentieth century, in the second half of the s a renewed focus on aedes aegypti was underscored by the politics of democratisation, following the end of the -year-long military dictatorship in . as by april it had become identified with dengue fever, as a new disease to plague urban 'areas marked by racialised histories of state abandonment and violence', the aedes aegypti became associated with a disease that was not as lethal as yellow fever, and which bore with it the sign of social, political and economic restitution. as public health had been the pejorative of left-wing and other democratic forces during the last decade of the dictatorship, calls to control dengue-carrying aedes aegypti as an embodiment of state violence and neglect contributed to the success of the 'sanitary reform movement' and the establishment, in , of brazil's sistema Único de saúde. lopes and reis-castro then turn their attention to the latest incarnation of aedes aegypti as a spreader of the zika virus. unfolding during the years of the impeachment (or judicial coup, depending on one's point of view) against dilma rousseff, the appearance of zika in brazil involved aedes aegypti in an international emergency. lopes and reis-castro examine the political struggles around zika-related mosquito control and argue that, focused on social inequality and the 'uneven effects of climate change', this new framing of the aedes aegypti on the one hand continues a longestablished practice of problematising it as a disease vector with specific political and political-economic parameters, while, on the other hand, introducing important gender-related critiques of public health. hence, while the authors claim that, 'the specific kind of virus in mosquitoes' bodies shaped what kind of epidemic villain the mosquito became', they also stress that, 'the mosquito as a vector carried not only three epidemiologically distinct viruses but very different political desires, struggles, and debates'. focusing on the recent zika crisis, in their chapter to this volume gustavo corrêa matta, lenir nascimento da silva, elaine teixeira rabello and carolina de oliveira nogueira in turn argue that the focus on mosquitoes' guilt and on the technological strategies developed to control these vectors unfolded within a context of profound political instability, and at the same time of epistemic uncertainty regarding key epidemiological traits of the disease. framing aedes aegypti as epidemic villains in this context, diverted attention from issues of social, economic and environmental injustice and inequality that were driving determinants of the outbreak, and legitimised the absence of governmental measures regarding the latter in response to the epidemic. the 'enactment of a global enemy, aedes aegypti, as the villain of the epidemic' thus allowed the brazilian government to paint an all-too-familiar and deceptive picture of a promethean struggle of the country as a unified whole (notwithstanding its enormous and often violent class, race, gender and ideological discrepancies and antagonisms) against a vile creature, which was solely held responsible for the disease. drawing on critical medical anthropological perspectives, matta et al. thus underline the structural violence inherent in both the discourse of epidemic villains and in the policies built and legitimated by this discourse. brazil's mosquitocentred policy in the face of zika, financially, politically and morally boosted by the declaration of public health emergency of international concern (pheic) by the who, relied on a securitisation framework that rhymed well with the broader neoliberal turn of the country and mobilised the image of the mosquito as a public enemy to create a spectacle of national unity that obscured 'iniquities, poverty, the skin colour of those bitten by mosquitoes, the house and streets where these fly, and the environment where they lay their eggs'. as mark honigsbaum has shown, disease ecology frameworks, arising in the usa in the s, framed non-human animals not simply as spreaders of infectious diseases but also as their 'reservoirs'. the 'great parrot fever epidemic' of - involved pet parrots in an epidemic panic across the globe, with a particular focus in the usa. as readers of the colonialist bande dessiné exemplar, tintin in the congo (published in the shadow of the epidemic in ), may remember, psittacosis (caused by chlamydia psittaci) is a zoonotic disease carried by parrots and parakeets that can infect humans. however, for karl f. meyer, a key contributor to the development of disease ecology, the ability of parrots and parakeets (popular pets at the time in the usa) to be asymptomatic carriers of the disease posed a more important problem that the immediate epidemic crisis; especially, honigsbaum explains, as '[t]hese latent infections were a particular problem in california where during the depression many people supplemented their incomes by breeding parakeets in backyard aviaries'. the discovery that psittacosis was not simply an 'exotic' disease imported to the usa by parrot traders, but one that had established itself endemically in american aviaries transformed the structure of epidemic blame from one focused on an outbreak to one focused on an endemic and, at the same time, from one revolving around an exotic invasion to one regarding unhygienic infrastructures at home. more profoundly, it also contributed to a shift towards a reframing of animal-borne disease in terms of disease ecology, a process which involved several decades of studies and interdisciplinary exchanges, but was ultimately triggered by an integration of charles elton's pathbreaking understanding of animal zoology in the realm of epidemiology. what is less well recognised historically is that the notion of the reservoir had a long history in epidemiological reasoning predating disease ecology. rats in particular were suspected, from as early as , as not only spreading plague (via their flea, xenopsylla cheopis ) but as also contributing to the maintenance of persistence of the disease in given urban settings. indeed, elton's interest in the role of disease in the regulation of animal populations was itself stimulated by earlier russian and chinese studies of the siberian marmot as a host of plague in the inner asian steppes. in chapter of this volume, christos lynteris returns to these studies to examine how the so-called tarbagan became the subject of investigations regarding plague's ability to survive the harsh winters of the region. the question was related to ideas about 'chronic plague', which in the case of the siberian marmot were linked to its hibernation between october and april. using an abundance of visual material, lynteris argues that, on the one hand, tarbagan burrows, which had been epistemic objects ever since the discovery of the species in , and, on the other hand, marmot hibernation, which had been the focus of scientific investigation in relation to host immunity already by , were tied together into an epidemiological duet as a result of the emergency of the manchurian plague epidemic of - . there is indeed a crucial metonymic work involved in this tying together the 'mystery of the survival of plague' over winter to marmot hibernation, and marmot underground dwellings. for the three actants in this network of what following genese sodikoff, we may call 'zoonotic semiotics'-latent plague, hibernating marmots, underground burrows-shared and maintained between them an image of 'mystery' and occultation which has been key both to epidemiological reasoning regarding infectious diseases and to the 'pandemic imaginary' underlying understandings of zoonosis. this image of plague taking advantage of unseen biological processes, materialities or infrastructures so it can assume an imperceptible form that would allow it to persevere over either human action against it or environmentally adverse conditions is of course reliant on pasteurian notions virulence, latency and attenuation. yet, more than simply illuminating a reiteration of bacteriological doctrine, what the tarbagan example points out to is a pervasive aspect of epidemiological reasoning; for the assumption that, when plague (or indeed any other disease) is not seen, this is because it is 'hiding', is part of what we may call a cynegetic complex in epidemiology. as john berger once noted, admittedly in a very different context, a key principle (and, one may add, a mythic structure) of cynegetic worlds is that, 'what has vanished has gone into hiding'. in the case of epidemiology, as with other cynegetic cosmologies, this implies an ambivalent relation. on the one hand, microbes are seen as predators of humanity, who lurk and hide so as to better ambush their prey. and on the other hand, as the enduring metaphor of 'virus hunters' amply illustrates, microbes are also seen as humanity's pray-which thus 'hide' to escape being caught and vanquished by us. as frédéric keck has stressed (following chamayou), '[w]hereas pastoral techniques are asymmetrical, relying on the pastor's superior gaze over the flock manifested by sacrifice, cynegetic techniques are symmetrical, as hunters and prey constantly change perspectives when displayed in rituals'. maurits meerwijk's chapter in the present volume shows that this is indeed a historically pervasive framework, which in the case of mosquitoes is carried over from tropical medicine into global health. comparing the discourses of ronald ross and bill gates, meerwijk shows how the cynegetic metaphor comes to encompass not only the pathogens in question but also their vectors. this points out at a transformative ontology underlying epidemiological reasoning, and its obsession with the 'invisibility' of disease, insofar as pathogens are seen, on the one hand, as able to persist by transforming themselves inside non-human animal hosts (by means of attenuation or mutation) and, on the other hand, as able to spread by transforming their hosts into bestial man-hunters. more than simply blaming non-human animals, in epidemiological reasoning, this double transformative ability configures the former into the loci par excellence of pathogenesis and, at the same time, necessitates techniques of rendering host-pathogen relations visible. visual images of non-human animals have played a historically important role in their configuration as epidemic villains. since the dawn of bacteriology, the scientific identification and examination of non-human hosts and vectors of infectious diseases have heavily relied on photographic technologies (including microphotography), diagrams and epidemic cartography. following sayer (this volume), animals have been 'fed into a data-focused visual regime', combining photography, mapping, diagrams and statistical graphs, that seeks to establish points of contact, habitats, interspecies boundaries and other forms of what hannah brown and ann h. kelly have called human/non-human 'material proximities'. in the context of high-modern epidemiology as well as in today's eid framework, these visualisations are part of a project of mastery aimed not so much at the subjugation of nature, as to the control of humanity's relations with nature. diagrammatic images of dissected mosquitoes played a key role in ronald ross' examination of the insects as malaria vectors, as, in later years, the microphotography of anopheles gambiae dissected ovaries would prove an indispensable, soviet-led method for identifying the capacity of a given mosquito to transmit the malaria plasmodium to humans. similarly, nicholas evans has shown, in the course of the third plague pandemic, comparative images between healthy and plague-infected rats became standard visual objects in epidemiological investigations and their published reports. but the visualisation of 'epidemic villains' did not always necessitate their direct representation. in her chapter for this volume, sayer draws an insightful comparison between two sets of visualising rat control, the first in the english port of liverpool and the second in british india. in both cases, the actual rats are imperceptible, with the photographic focus being on humans undertaking carefully orchestrated epidemiological work (rat dissection, flea collection); a fact which, in the case of liverpool, is underlined by the staged poses of the sanitary officers in questions, and, in the case of india, was permeated by colonial racial hierarchies in the representation of lab work. as representations of the relation between pandemic plague, medical science and empire, these images provide reassuring portraits of control in direct dialogue with the image of objectified rats, described by evans, thus 'making rats an integral part of plague'. similarly, with a focus on this relational aspect of human/non-human mastery and its visual regimes, in the second chapter of this volume lynteris illustrates how the epidemic framing of siberian marmots as reservoirs of plague in inner asia relied on photography and the diagrammatic cartography of their burrows. comprising in survey photographs of excavated marmot burrows and diagrammatic depictions of burrow systems, the visual regime constructed around this suspected host of plague following the manchurian plague outbreak of - comes to show, on the one hand, that intrusive practices of epidemiological visualisation were not limited to human dwellings, but also included those of non-human animals (photographing the marmot burrows required their prior excavation), and, on the other hand, that the visual framing of 'epidemic villains' is not limited to the representation of their role as spreaders of diseases. at the same time, the popularisation of the identity of specific mammals, birds and insects as disease spreaders has and continues to be mediated by their visual representation through photography, film and illustration. photographs of 'wet markets' in south china during and in the aftermath of the sars pandemic have been shown to incorporate a key principle of 'epidemic photography': the depiction of animal-related spaces as potential ground zeros of the 'next pandemic'. the practice of the public vilification of non-human animals and the framing of contact spaces between them and humans as infection hotspots was established for the first time in the course of anti-malarial and anti-yellow fever campaigns in the first decades of the twentieth century, but also during complex public health operations against plague in the context of the third plague pandemic ( - ) when the dreaded disease was often visually personified as the rat. indeed, quite often, the image of animals as enemies of humanity assumed anthropomorphic aspects, which under a colonialist gaze, involved racist inflections. in australian newspaper illustrations, for example, plague-carrying rats were depicted having chinese faces, thus both making an aetiological connection between plague and china (plague as an 'oriental disease' arriving from china, by chinese migrants) and fostering broader sinophobic bigotry at the time. in his examination of the framing of 'tiger mosquitoes' (aedes aegypti and aedes albopictus ) in this volume, meerwijk explores the rich visual culture supporting progressive framings of the specific mosquito species as infectious enemies of humanity. in a striking example, meerwijk shows how the diagrammatic juxtaposition of a mosquito and a tiger was used in a public health poster, meant to underline the predatory, man-eating qualities of aedes mosquitos. pointing at a pervasive tendency to talk about and visualise mosquitoes in terms of great predators (tigers, sharks) or 'enemies of humanity' (terrorists, vampires, prostitutes), meerwijk elucidates the work of the fusion between military, cynegetic and sexual metaphors and visual tropes employed in the depiction of mosquitoes across epidemiological paradigms. this is all the more important as the visualisation of animals as 'epidemic villains' was a trope that found application and success beyond epidemiology and public health. non-human animals were charismatic protagonists of political caricatures since the turn of the eighteenth century. in particular, lukas englemann notes, 'the "political bestiary", as gombrich calls the long tradition of depicting political issues through animal characters, acquired widespread popularity in the nineteenth century. the meaning many animals inhabited could be easily exploited to convey strong messages and almost always suggested degradation'. what changed at the turn of the nineteenth century was the introduction of a new aspect in the use of animals in caricature: their infectious nature. with political discourse utilising more and more medical terms at the time, the use of the visual form of the infectious animal to portray one's political enemies became an exemplary field of vilification. to mention only one example, in the course of the moscow trials, soon after the soviet state prosecutor, andrey vyshinsky, publicly pledged 'to stamp out the accursed vermin' who 'should be shot down like rabid dogs', the prolific cartoonist of the pravda, boris efimov (who was present at the trial), produced a striking caricature of leon trotsky and nikolai bukharin as a two-headed rabid dog held on the leash by the hand of the gestapo. however, as engelmann has shown in his examination of caricatures in the course of the plague outbreak in san francisco, the aim of depicting animals in the context of epidemic crises has not been limited to practices of blaming the former as spreaders or reservoirs of disease. in fact, animals were also used to critique and ridicule bacteriology itself. for example, in the case of san francisco, newspaper caricatures used animals to portray bacteriology 'as a science that formulated its judgments through experiments with animals, not in the treatment of people'. by visualising laboratory animals as 'vermin and pest', englemann argues, bacteriology was portrayed as 'a wasteful expenditure of public funds' and 'the medical laboratory was stripped of its progressive potential and instead appeared as an infliction of damage on the public good'. at the same time, as dawn day biehler has shown in her monograph on pests in twentieth-century us history, images of disease hosts, like rats, have also been used for subaltern purposes, such as the campaigns by the black panther party in the s- s against slumlords and the living conditions in african american neighbourhoods. for example, biehler argues, the well-known illustration by emory douglas, 'black misery! ain't we got right to the tree of life?', 'constrast[ed] with images of women afraid of rats; the woman's grip on the rat suggests determination, courage and fury'. here, the rat represented the unhygienic, exploitative and pestilential conditions imposed by white capital on working-class african americans, and the latter's determination to face up to this social injustice. the prolific use of images of non-human animals as 'epidemic villains' in diverse fields of social practice as public health campaigns, political propaganda, the critique of bacteriology and subaltern critiques of power and domination, points at the importance placed on the infectious nature or potential of animals both as a reality and as a metaphor in the modern world. however, whether it is to convey a threat to the national body, or to mock science, the use of these images also points at the fascination and discomfort of moderns towards non-human agency. underlining how epidemiology and public health emerged in relation to, and continue to be informed by framings of non-human animals as epidemic villains, the chapters in this volume explore the layered political, symbolic and epistemic investments of non-human animals, as these have become rhetorically and visually enabled in distinct ways over the past years. whether it is stray dogs as spreaders of rabies in colonial and contemporary india, bushmeat as the source of ebola in west africa, mosquitoes as vectors of malaria, dengue, zika and yellow fever in the global south, or rats and marmots as hosts of plague during the third pandemic, this volume shows framings of non-human animals to be entangled in local webs of signification and, at the same time, to be global agents of modern epidemic imaginaries. civet cats, fried grasshoppers, and david beckham's pajamas: unruly bodies after sars' the pandemic perhaps: dramatic events in a public culture of danger the scale politics of emerging diseases more than one world more than one health: reconfiguring inter-species health i am using animal-borne diseases here as a term inclusive of zoonotic and vector-borne diseases the rat-catcher's prank: interspecies cunningness and scavenging in henry mayhew's for an influential example of the rat being described as disease-free, see cristofano and the plague: a study in the history of public health in the age of galileo the rat would become suspect of carrying plague for the first time during the inaugural outbreak of the third plague pandemic, in hong kong, with another decade elapsing before the universal acceptance of the link between the animal and human plague. the first scientific study showing the role of the rat and its flea in the propagation of plague was: p. l. simond, 'la propagation de la peste imagining vermin in early modern england the great cat massacre and other episodes in french cultural history religion and the decline of magic: studies in popular beliefs in sixteenth and seventeenth century england imagining vermin in early modern england imperfect creatures: vermin, literature, and the sciences of life on vermin and the poor, see p. camporesi, bread of dreams: food and fantasy in early modern europe animal bodies, renaissance culture filth is the mother of corruption". plague, the poor and the environment in early modern florence que la peste soit de l'animal! la législation à l'encontre des animaux en période d'épidémies dans les villes des pays-bas méridionaux et de la principauté de liège ( - ) que la peste soit de l'animal!'; on ideas of miasma emanating from butchered meat see d. r. carr, 'controlling the butchers in late medieval english towns great stenches, horrible sights and deadly abominations": butchery and the battle against plague in late medieval english towns infection," and the logic of quarantine in the nineteenth century fractured states: smallpox, public health and vaccination policy in british india toxic histories: poison and pollution in modern india as kathleen kete has shown, the modern transformation of this connection, before the dawn of bacteriology, was fostered by a sexualisation of the disease, which rendered it comparable to uncontrollable impulses or lust. commenting on kete's work, linda kalof writes: 'since nymphomania and uncontrollable sexual desire in men were considered the result of prolonged sexual abstinence the beast in the boudoir: petkeeping in nineteenth-century paris looking at animals in human history healing the herds: disease, livestock economies, and the globalization of veterinary medicine veterinary research and the african rinderpest epizootic: the cape colony the great epizootic of - : networks of animal disease in north american urban environments' beastly encounters of the raj: livelihoods, livestock and veterinary health in india animals and disease: an introduction to the history of comparative medicine from coordinated campaigns to watertight compartments: diseased sheep and their investigation in britain, c. - unpacking the politics of zoonosis research and policy catching the rat: understanding multiple and contradictory human-rat relations as situated practices blaming the rat? accounting for plague in colonial indian medicine the bacteriological city and its discontents' malarial subjects: empire, medicine and nonhumans in british india what is an epidemic? aids in historical perspective wartime rat control, rodent ecology, and the rise and fall of chemical rodenticides urban mosquitoes, situational publics, and the pursuit of interspecies separation in dar es salaam the colonial disease: a social history of sleeping sickness in northern zaire the mobile workshop: the tsetse fly and african knowledge production cat and mouse: animal technologies, trans-imperial networks and public health from below building out the rat: animal intimacies and prophylactic settlement in s south africa'. american anthropological association (engagement modern" management of rats: british agricultural science in farm and field during the twentieth century of rats, rice, and race: the great hanoi rat massacre, an episode in french colonial history for a more detailed discussion of this process, see c. lynteris, 'zoonotic diagrams: mastering and unsettling human-animal relations' curing their ills: colonial power and african illness rethinking human-nonhuman primate contact and pathogenic disease spillover the scale politics of emerging diseases the pandemic perhaps avian preparedness: simulations of bird diseases and reverse scenarios of extinction in hong kong unprepared: global health in a time of emergency the pandemic perhaps great anticipations human extinction and the pandemic imaginary for discussion, see k. ostherr, cinematic prophylaxis: globalization and contagion in the discourse of world health inclusivity and the rogue bats and the war against "the invisible enemy as fairhead argues, this entanglement of 'native culture' with 'rogue animals' has the effect of transferring the status of the 'rogue' to the 'culture' in question; fairhead, 'technology, inclusivity and the rogue bats and the war against "the invisible enemy"'. see also m. leach and i. scoones, 'the social and political lives of zoonotic disease models: narratives for a discussion of disgust and animal disease, see a. l. olmstead, arresting contagion. science, policy and conflicts over animal disease control it needs to be noted here that, following fissell, the emergence of the early modern notion of 'vermin' was not associated with disgust-something that points to the introduction of this affective and sensory structure in the nineteenth century imagining vermin in early modern england serviço permanente de prevenção e combate à peste bubónica no sul de angola: relatório (lisboa: agência geral das colónias the sanitation of brazil: nation, state, and public health latent infections, and the birth of modern ideas of disease ecology' tipping the balance blaming the rat? plague and the regulation of numbers in wild mammals Évolution de la peste chez la marmotte pendant l'hibernation'. comptes rendus hebdomadaires des séances de l'académie des sciences for a more detailed examination of zoosemiotics in the case of marmots, see c. lynteris, 'speaking marmots, deaf hunters: animal-human semiotic breakdown as the cause of the manchurian pneumonic plague of - on the ambivalence as applies to hunters and gatherers, see r. willerslev lessons in medical nihilism. virus hunters, neoliberalism and the aids pandemic in cameroon on chamayou's theory, see grégoire chamayou, manhunts: a philosophical history for a discussion of the mythic ability of pathogens to transform their hosts into man-hunters, see c. lynteris, 'the epidemiologist as culture hero: visualizing humanity in the age of "the next pandemic on diagrams and the configuration of zoonosis, see lynteris the evolution of ebola zoonotic cycles'. contagion material proximities and hotspots: toward an anthropology of viral hemorrhagic fevers' human extinction and the pandemic imaginary seeing cellular debris, remembering a soviet method' blaming the rat? on the practice of intrusive epidemic photography as regards human dwellings, see r. peckham, 'plague views. epidemic, photography and the ruined city the prophetic faculty of epidemic photography: chinese wet markets and the imagination of the next pandemic this 'global visual economy' was so pervasive in fact so as to lead to a retrospective diagnosis of the presence of rats in paintings such as nicholas poussin's the plague of ashdod as evidence of a pre-bacteriological knowledge of this zoonotic connection; for a critique, see s. barker yellow peril epidemics: the political ontology of degeneration and emergence a plague of kinyounism: the caricatures of bacteriology in san francisco the sharp weapon of soviet laughter: boris efimov and visual humor a plague of kinyounism', p. . . ibid pests in the city: flies, bedbugs, cockroaches, and rats (washington key: cord- -drjfwcdg authors: shephard, roy j. title: building the infrastructure and regulations needed for public health and fitness date: - - journal: a history of health & fitness: implications for policy today doi: . / - - - - _ sha: doc_id: cord_uid: drjfwcdg . to recognize the importance to the maintenance of good health of adequate public health regulations and an infrastructure that provides clean water and appropriate waste management. . to see the lack of such amenities over many centuries, but the progressive development of public health bureaucracies dedicated to provision of an appropriate infrastructure for healthy cities, beginning during the victorian era. . to observe how responsibility for the provision of adequate housing for poorer city dwellers has been shared between government, benevolent entrepreneurs and charities. . to note the new challenges to public health presented by such current issues as the abuse of tobacco and mood-altering drugs, continuing toxic auto-emissions, the epidemic of hiv/aids, a decreased acceptance of mmr vaccinations, and the ready spread of infectious diseases by air travel. opportunities for the spread of communicable diseases have increased with the growth in size of cities. the success of urban living has depended in great part on governmental ability to maintain population health through the building of an adequate infrastructure to provide clean water and to dispose of waste, as well as the enactment of appropriate regulations to control the prevent the spread of infectious diseases. in this chapter, we will look at success in meeting these objectives in various communities from early history through the classical era, the arab world, mediaeval europe, the renaissance, and the enlightenment to the victorian era, concluding with some comments on current challenges to public health. in the hey-day of the persian empire, heat, cold, dirt, stench, old age and anxiety were all thought to contribute to ill-health. cyrus the great ( - bce) thus taught his soldiers not to urinate or spit into running water. dead matter was also carefully removed from water-courses, and the clothing of dead people was systematically burnt. during the mediaeval era, interest in public health was much more advanced in the islamic world than in northern and western europe. ali ibn-rabban ( - ce), a well-respected physician living on the south coast of the caspian sea, wrote in his seven-part medical work paradise of wisdom that: "no one should live in any country which does not have four things: a just government, useful medicaments, flowing water and an educated physician." in the eleventh century, the arabic biographer al-mussawir emphasized that the main duty of a monarch was the preservation of health and well-being in his subjects. thus, islamic legislation required physicians to pay regular visits to army units, prisons and people living in outlying areas. the practice of medicine was regulated through a religious office, the hisba, headed by an official called the muhtasib with some of the powers of a modern ombudsperson. one function of the muhtasib was to act as the city medical officer of health. he prevented people with elephantiasis from using the public baths, regulated the cleanliness of public places such as markets, and ensured that garbage collectors did not handle food. one interesting example of applied hygiene was the method used to determine an appropriate location for construction of the main hospital in baghdad (chap. ). the merits of various sites were compared by hanging up pieces of meat, and noting the location where decomposition proceeded the most slowly. the city of córdoba under moorish rule further illustrates the infrastructure typical of the arab world during the tenth century ce. among other facilities, the city boasted public baths. in northern and western europe, public health infra-structure such as aqueducts and sewers fell into disrepair following departure of the roman garrisons, and during the mediaeval era the sanitary conditions in most cities were appalling. positive developments were the development of quarantine procedures and the re-emergence of a few public baths. food inspectors were appointed, and some cities also introduced zoning regulations, requiring malodorous trades such as tanning to be undertaken outside the city walls. water supply and sewage disposal untreated waste was thrown directly into the rivers of london and paris, and travellers were advised: "wise men go over bridges, and fools go under them." in ce, king edward iii ordered the mayor of london to: "cause the human faeces and other filth lying in the streets and lanes in the city top be removed with all speed to places far distant, so that no greater cause of mortality may arise…" a fourteenth century ordinance prohibiting the emptying of latrines into a creek near london's city wall remained largely ignored, so that in the fifteenth century the stream was buried underground. substantial populations of hogs and cattle roamed the streets of many large cities, adding to the urban stench. uncontaminated water was a rarity, and a lack of refuse disposal encouraged rat infestations. infrequent bathing and unwashed woolen clothing led to a proliferation of fleas and other insect vectors of infection. during the mid-fourteenth century, two thirds of the european population was killed by the flea-borne bubonic plague (the "black death", - ce). many doctors deserted their patients during this epidemic, and others proposed preposterous remedies. guy de chauliac wrote: "so contagious was the disease…. that no one could see or approach the patient without taking the disease…for self-preservation, there was nothing better than to flee the region… to purge oneself with pills of aloes, to diminish the blood by phlebotomy and to purify the air by fire and to comfort the heart with senna and things of good odor and to soothe the humours with armenian bole and resist putrefaction by means of acid things." chauliac unwittingly kept the rats and fleas away from pope clement vi, by surrounding his bedside with charcoal burners. a few years following the black death, observant physicians hypothesized that ships arriving from overseas were contributing to the recurring epidemics of plague. at first, hostels for sick townsfolk and newly arrived visitors were set up outside the city, but this was not entirely effective in containing infection. thus in ce, a trentino ( days) of isolation on an uninhabited island was required at many european ports of entry. subsequently, the isolation period was extended to days, perhaps because of an ancient greek doctrine that a contagious disease became manifest within days. in britain, recently arriving travellers were quarantined on guardships, anchored in the thames estuary ( fig. . ). most of the roman baths in northern europe had been abandoned by the mediaeval era, in part because of the high cost of heating the bath water, and in part because the church considered public bathing as a common prelude to venal sins. the church also had concerns about reinforcing belief in the supposed healing powers of celtic water deities (chap. ). nevertheless, as prosperity increased in the latter part of the middle ages, public baths were built or reopened in various parts of europe. in britain, the king's bath was built over the sulis minerva temple in the city of bath, and paris had established public baths by the thirteenth century. in germany, the tradition of river bathing had persisted from celtic times, and a growing number of new public bath-houses were constructed during the th and th centuries. admission to a bath-house was expensive, and poorer germans considered the payment of "bath money" a great blessing. the full luxury package of a spa treatment included washing, scouring and slapping of the body with a sheaf of twigs, a steam bath, rubbing to induce perspiration, swatting the skin with wet rags, scratching, hair washing, cutting and combing, lavendering, and blood letting. unfortunately, some of the baths subsequently became the scene of debauchery, prostitution and infection, and by the sixteenth century, many were closed for fears of spreading syphilis, leprosy and plague ( fig. . ). personal hygiene substantial quantities of soap were traded during the mediaeval era, but this was used more for the washing of wool than for cleansing of the skin. monasteries boasted laundry rooms, and many women listed their trade as "laundry woman." however, the laundering of clothes was an infrequent luxury for poorer people, and indeed many had no spare set of clothing, so that fleas flourished in the poorer households. food inspection basic foodstuffs such as wine, beer, bread, meat, fish and salt were frequently adulterated in mediaeval times. to counter such abuses, several european governments appointed food inspectors. in britain, in , the assize of bread and ale regulated the price of these staples in relation to the price of corn. occasional renaissance scholars expressed some interest in health promotion. the english diplomat and scholar thomas elyot (c. - ) wrote a book entitle the "castell of health," summarizing the latest medical knowledge for those unfamiliar with greek, and the venetian nobleman luigi cornaro ( - ) wrote a book on the art of living a long life. santo santorio (chap. ) also sought to put hygiene on a mathematical basis. most of renaissance society showed little interest in public health or hygiene, as shown by the outbreak and management of the great plague. however, boards of public health were set up in some cities. two small advances in personal hygiene were the introduction of cotton clothing and a growing use of toothbrushes. diligent housewives adopted a few other simple changes in household management to preserve the health of their families, and cambridge university insisted on a direct control of its food supply, the great plague the london "plague" of ce was one in a series of european epidemics of bubonic plague dating back to the "black death." the great plague claimed at least , lives in central london, this being about a half of the population who had not fled from the city. indeed, the death count was probably underestimated, since publically appointed street monitors were open to bribery by those who did not wish to disclose that their house had become infected. samuel pepys commented that the prevalence of the disease was such that corpses could not removed during the hours of darkness ( fig. . ). people were confined to their homes if one family member was infected, thus virtually ensured the death of the entire household. two watchmen were posted at the doors of infected homes for days, at a cost of d per house per day, and the victims received a public stipend of d per day to pay for food, fuel and medicaments. believing that the disease was conveyed by miasmata, the college of physicians recommended using bonfires to displace the infected air. there was probably some incidental benefit from these fires, since the smoke tended to drive away the flea-ridden rats that were vectors of the disease. the epidemic was eventually checked by the great fire, which consumed both the rats and the plagueinfested slum dwellings. in europe, local boards of public health were established; they adopted various measures for the containment of epidemics and the provision of social support to the community. in some cases, they designated specific physicians to attend plague victims, and in florence, local doctors prepared a public information booklet that summarized current knowledge on plague prevention. a further responsibility of these boards was to deal with doctors who failed to report communicable diseases in wealthy patients. one roman doctor who was arrested for this offence was ordered to serve as resident physician at the local pest-house. outbreaks of the plague placed a severe financial stress upon some municipalities. in milan, extra funding was needed to hire physicians and grave-diggers, to pay for operating a quarantine "pest-house," and to reimburse the infected for two-thirds of the estimated value of their possessions, which were summarily burned. some municipalities set up immigration offices on mountain passes to control the arrival of infected travelers, and others restricted imports, exports, market trading, travel and funerals, although it was unclear how far these costly measures were successful in reducing the toll of disease and mortality. personal hygiene and household management one positive development during the renaissance was the introduction of washable cotton clothing and sheets. this greatly curtailed the spread of insect-borne diseases, particularly among those with sufficient wealth to own several changes of clothing. another innovation was popularization of the bristle toothbrush. this device had been invented by the chinese in the thirteenth century, but did not become popular in england until the late seventeenth century, beginning with the aristocracy. without necessarily knowing why, tudor housewives achieved some sterilization of their dairy equipment by scouring with salt and hot water, and then exposing utensils to bright sunlight. infestation of houses by fleas was also countered by sprinkling appropriate herbs beneath the rush mats that covered their floors. the renaissance saw further occasional attempts to control the quality of food, particularly for the wealthy. cambridge university insisted that the direct supervision of their refectories was important to preserving the health and well-being of their students. one of those promoting hygiene during the enlightenment was the physician james mackenzie, who in wrote a text on "the history of health and the art of preserving it." the enlightenment saw some improvement of health infra-structure many dwellings for the poorer citizens of europe.were now constructed of brick and boasted glass windows. and samuel johnson ( - ) was urging a pro-active response to the prevention of disease:"we must consider how many diseases proceed from our own laziness, intemperance or negligence… and beware of imputing to god, the consequences of luxury, riot and debauchery." the diderot encyclopédie, first published in , included a section on hygiene, which wss defined as: "the things which mankind uses or handles… and their influence on our constitution and organs." gottfried wilhelm leibniz ( - ) was perhaps the greatest enthusiast for public health during this era. he strove to establish a pattern of medical training that was oriented towards public health and preventive medicine rather than the treatment of disease. he reminded his colleagues that hippocrates had registered every successful cure, and he urged a similar meticulous recording of outcomes in order to provide a modern preventive medicine data-base. he proposed that standardized questionnaires should be developed to examine eating habits, and that careful mor-the enlightenment tality statistics should be collected so that findings could be correlated with the local climate, air conditions and the nature of the soil. a few other scientists such as hales (who improved the water supply for his village of teddington), and bernouilli (with authored a probability study demonstrating the merits of vaccination) were also interested in public health. but concern about the provision of clean drinking water, adequate treatment of sewage and garbage, and protection against communicable diseases remained the exception rather than the rule, with most countries making a poor showing on indices of population health. francis bacon published studies on the percolation, filtration, distillation and coagulation of water as early as . anton van leeuenhoek described the microscopic animalicules that he had seen in dutch drinking water in , and the french scientist joseph amy patented a water filter in . however, the quality of water in most large cities left much to be desired. philippe de la hire ( - ) mapped the area around paris, seeking to improve the water supply to versailles, probably as much to service the palace ornamental fountains as to provide clean drinking water in the town, and he built a massive aqueduct for this purpose (fig. . ) . he further suggested that householders should install a sand filter to purify the water collected from the roofs of their dwellings, although he noted that one alternative source of water, from underground aquifers, was rarely polluted. in , paisley, scotland became the first british city to establish a municipal water treatment plant. it used a sand filter that had been developed by robert thom. in , paris also constructed a large water treatment facility on the seine; here, river water was allowed to settle for hours, and was then passed through sponge pre-filters and main filters that contained sand and charcoal. despite these advances, the residents of broad st., in central london, faced a massive outbreak of cholera as late as , because they were drawing water from a shallow well that was located close to a cholera-contaminated cess-pit. too often, the city dwellers of the enlightenment continued to pass sewage into open gullies or cess-pits that were fig. . ruins of an aqueduct, built by philippe de la hire to improve the water supply to the city of versailles and its royal palace (source: http://en. wikipedia.org/wiki/ canal_de_l'eure) close to wells, and garbage was thrown directly onto the street. however, in , the conseil supérieur of new france ruled that in order to reduce infection, the houses in quebec city must have latrines, and that garbage must be carried to the river st. lawrence, rather than simply thrown out of the door. populatiion health during the enlightenment vital statistics provide simple objective indices of overall population health during the enlightenment. at birth, the average european could expect to live no more than years. a third to a half of the population died before reaching the age of years. those who survived to their mid-teens lived into their s or even their early s, and at the age of the aristocracy could expect to live a further - years; this was an improvement over the years of adult survival typical of the fourteenth century. survival prospects were much worse in north america than in europe during the enlightenment. many of the population succumbed to fevers, intestinal diseases, and, in the case of the african slaves, to harsh working conditions. a quarter of european immigrant children did not survive until their first birthday, and half of all marriages ended in the death of one partner before their seventh wedding anniversary. epidemics of beri-beri, smallpox, malaria and yellow fever wreaked havoc among early colonists. two of every three deaths were attributed to typhoid, dysentery or salt poisoning. in an attempt to reduce this terrible toll, newly arrived immigrants were initially isolated in "guest houses." replacement of contaminated water by wine, beer or cider, a reduced consumption of infected clams, and a scattering of the population to areas where there were copious fresh water springs reduced deaths from typhoid and dysentery, but progress in reducing overall mortality was slow. in early canada, dispersal of the population along the major rivers made major epidemics less likely than in the urban settlements of the united states, but isolation, accidents and harsh winters made canadian life expectancy worse than those in either europe or the u.s. only a small fraction of the population lived beyond years, and many of the children suffered from rickets and anaemia. typhus and smallpox were also recurrent problems. the victorian era was marked by growing government responsibility for the health of the public in large european cities. there was a gradual improvement in the quality of housing, and demographics showed a burgeoning birth rate. social reformers also succeeded in abolishing child labour and slavery from western society (chap. ). in this section, we will discuss the role of boards of health, continued deaths from poisoning, and improvements in housing conditions. major epidemics of influenza, cholera, typhus, typhoid fever and scarlet fever sparked a deep concern about population health in victorian england. in london, england, cholera killed , people in - and , in (chap. ). however, leaders of a new sanitary movement such as edwin chadwick ( - ) and thomas southwood smith ( - ) began to recognize that ill-health of the individual soon became ill-health of the population. they thus made urgent calls for the provision of clean drinking water, proper removal of refuse and sewage treatment. chadwick and smith sat as commissioners on london's general board of health that regulated the water supply and sewer connections for all new housing in the city, and provided adequate burial grounds for those who died. the quality of london's drinking water was rapidly upgraded, and money was spent on methods of preventing death during childbirth. the public health acts of and also established public baths and wash-houses, and by the s, health-conscious municipalities were building public swimming pools. in lower canada (quebec), a physician was appointed as health officer in , with the primary responsibility of monitoring the sick and starving people who were arriving on immigrant ships from europe. by , a strengthened five-member board of health was supervising quarantine arrangements on grosse isle, in the st. lawrence river near to quebec city. nevertheless, the number of immigrants was such that this holding facility was at times overwhelmed, and cholera periodically reached quebec and montreal, killing between - % of the population. in , people also died of typhus while they were quarantined at grosse isle. a central board of health for both upper and lower canada was created in . compulsory vaccination against smallpox was introduced in the early s. in the united states, organization of sanitary reform began rather later than in canada. the city of new york enacted the metropolitan health bill in , creating a -person board of health. immigrants were processed on ellis island, just outside new york city. the original wooden structure was quickly destroyed by a catastrophic fire, but a stone replacement building opened in . many immigrants spent only a few hours in the facility, but those with contagious disease were summarily denied admission to the united states. continued deaths from poisoning many victorians died from eating adulterated or diseased food. one report to the british privy council ( ) estimated that % of meat came from diseased cattle. flour was expensive, and bakers frequently adulterated it with chalk (to whiten it) and alum; often, the bakers also kneaded the mixture with their bare feet. an act prohibiting the adulteration of food was passed in , but its enforcement was an option for local authorities, so that it was not very effective. cooking was typically done in tin-lined copper pans; wealthier citizens replaced the pots when the tin had worn away, but the poor could not afford to do this, and in consequence they sometimes developed copper poisoning. other sources of poisoning in the victorian home were leaking gas pipes, lead used in white paint, and arsenic used to colour wallpapers. in the early nineteenth century, the sudden influx of country folk into the major cities of europe created hideous slums: "in big, once handsome houses, thirty or more people of all ages may inhabit a single room." housing gradually improved over the victorian era, as many workers accumulated sufficient funds to purchase modest but well-built homes. enlightened industrialists also constructed model housing estates for their employees. robert owen ( - ) organized a model community for his workers at the new lanark mills, in scotland, complete with a nursery school. he envisaged an even more ambitious employee housing project in new harmony, in, but this project failed within two years. the quaker chocolate manufacturer george cadbury ( - ) built a model village for his employees around his factory at bournville, near birmingham, and in the u.s. george pullman, the railway carriage czar, built a model town at pullman, il, in . charitable foundations such as the peabody trust began to replace the worst of london's slums with solidly-built if spartan apartments (fig. . ). the first peabody block, at spitalfields, included dwellings for the poor, shops complete with accommodation for the shopkeepers, and on the top floor baths and laundry facilities for a total cost of £ , . in the united states, building codes were improved during the victorian era, and a national housing association was founded in , under the aegis of the commission on the congestion of population in new york. there were also attempts to persuade philanthropists to build model tenements at low rents; buildings were bought, renovated, and then rented to relocated slum dwellers who were given "friendly instruction" on management of their new households. despite substantial progress in the delivery of public health, there remain a number of continuing challenges in the twenty-first century. current issues include the definitive control of the sales of tobacco and mood-altering drugs, the regulation of automotive emissions and other source of urban air pollution, management of the hiv/aids epidemic, concern over a growing reluctance to accept childhood vaccinations, and the management of infections spread by international air travel. in the edwardian era, cigarette manufacturers had promoted their wares as the cure for various respiratory conditions such as asthma and hay fever. but in , the american physician isaac adler pointed to a growing incidence of lung cancer, and he speculated that the abuse of tobacco and alcohol might be responsible. anti-smoking groups developed in germany following world war i, and a magazine (german tobacco opponents) was published from to . the nazi regime was opposed to smoking, with hitler declaring it a waste of money. in particular, women who smoked were considered as unsuitable to be german wives and mothers. during world war ii, the axis powers made much propaganda from the fact that hitler, franco and mussolini were non-smokers, whereas churchill, roosevelt and stalin were all heavy users of tobacco. evidence of the toxicity of tobacco steadily accumulated during the modern era. in , fritz linkint dresden demonstrated an increased prevalence of lung cancers in smokers. his research was confirmed in , with a case-control study by franz hermann muller of cologne. during the s, ernst wynder at the sloan-kettering institute in new york and richard peto and bradford hill at oxford university advanced even more compelling evidence that cigarettes were carcinogenic. hill concluded that consuming cigarettes per day increased the odds of dying from lung cancer as much as forty-fold. other damning evidence came from cellular pathology, animal experimentation and the demonstration of toxic chemicals in cigarette smoke. however, for a substantial part of the post-modern era, public health workers had to combat a deliberate campaign by the cigarette manufacturers to confuse and deceive the general public. the manufacturers were well aware of the damning facts by the early s, but their misleading propaganda was able to increase u.s. cigarette sales to a peak of billion units in . as late as , only a third of u.s. doctors considered smoking as "a major cause of cancer," and % of physicians were still smoking on a regular basis. beginning in the mid s, there was a dramatic decrease in the social acceptability of cigarette smoking, and growing restrictions were placed on public areas where smoking was permitted. this resulted from demonstrations that passive exposure to cigarette smoke gave rise to small but significant increases in the risks of chronic respiratory disease and asthma in childhood, and carcinoma of the lungs and cardiovascular disease in adults. public polls showed a growing acceptance of public health measures to control smoking in public spaces. cigarette manufactur-ers went to particularly great pains to obfuscate the risks of passive exposure to cigarette smoke, but adverse effects were clearly demonstrated during the s, not only by epidemiological research, but also by the exposure of volunteers to machine-generated cigarette smoke while they exercised in closed chambers. public health workers continue to face many challenges in reducing the sales of tobacco products, as manufacturers doggedly resist measures to reduce consumption through increased taxation, prohibition of sponsorships, and plain packaging. they constantly seek methods of creating new addicts, both through extensive advertising in third world countries and through such tactics as the marketing of electronic cigarettes. as recently as , cigarette smoking still accounted for . % of deaths world-wide. the toll from cigarettes is now compounded by the effects of mood-altering drugs. several countries (including canada) have abandoned attempts to prohibit the marketing of marijuana, with as yet no clear standards of dosages compatible with worker and road safety, and an ever growing segment of the north american population is becoming addicted to powerful opiates, with a high risk of deaths from overdoses. british columbia alone had deaths from opiate overdoses in , despite providing emergency workers with supplies of the antidote naloxone. the modern era saw a dramatic drop in the sulphurdioxide/large particulate smog associated with coal fires in many developed societies, but air pollution problems have continued from coal-fired power station and sautomotive emissions, particularly during thermal inversions. the exposure of cyclists and pedestrians to carbon monoxide was studied during the s. substantial concentrations of carbon monoxide were recorded on congested city streets, particularly if air movement was impeded by tall buildings, but any build-up of carboxyhaemoglobin in the blood stream was reversed quite quickly when the individual moved to a less polluted area. the only adverse clinical effect from carbon monoxide exposure was a somewhat earlier onset of angina if a person with coronary atherosclerosis exercised on a heavily polluted street. chamber experiments by steve horvath in santa barbara, ca, and larry folinsbee in toronto documented acceptable ceilings of exposures to the ozone that was formed by the action of sunlight upon the nitrogen oxides from vehicle and aircraft exhaust. the threshold concentration causing a minor disturbance of respiratory function in healthy exercisers was around . p.p.m., a level that was exceeded in some north american cities on heavily polluted days. to date, in many cities improved automotive emission controls have done little more than match the increase in vehicle registrations, and places such as paris and beijing have needed to forbid the access of drivers to the centre of cities on alternating days in order to reduce pollution levels. since ozone levels show a marked diurnal cycle, one immediate remedy for the active individual is to exercise at less heavily polluted times of the day (early morning or late at night). the ultimate solution to the problem of automotive exhaust probably lies in the replacement of gasoline-driven by electric or hydrogen-powered vehicles. the hiv/aids epidemic officially began in the u.s. in , when the centers for disease control reported a clustering of cases of pneumocystis pneumonia among homosexual men in los angeles. it was quickly realized that the condition was not limited to homosexual individuals, but was seen also in intravenous drug users, haemophiliacs and others receiving blood transfusions. thus, in august , the cdc coined the new term aids. a year later, luc montagnier and his associates at the pasteur institute in paris discovered the virus responsible for this disease. much effort has since been devoted not only to finding highly effective antiretroviral agents, but also in devising measures to reduce transmission of the disease. particular emphasis has been placed upon the wearing of condoms during sexual intercourse, in providing sterile needles for intravenous drug users through programmes of needle exchange and supervised injection sites, in closer control of blood banks and in ensuring sterility during drug injection treatments of tropical diseases. nevertheless, success in controlling the epidemic has as yet been only partial. in the u.s. the disease had already claimed , lives by ; a further million were living with the disease, and , fresh cases were diagnosed in that year. in rural africa, the situation remains even worse, with as many as a third of young adults currently infected. during the early part of the post-modern era, successful childhood vaccination campaigns brought the incidence of mumps, measles and rubella to a very low level in most developed countries, and the who set the year ce for the total elimination of measles and rubella from the european region. however, the percentage of children receiving vaccination has decreased in recent years, with parents weighing the low current risk of infections relative to the supposed dangers of developing meningo-encephalitis and autism. fears that vaccination would cause autism stemmed from a paper published by the british physician andrew wakefield, in . extensive research found no evidence to support his claims, and the british medical journal recently declared that the original article was fraudulent. further, the british general medical council found wakefield had been guilty of serious professional misconduct, and he was struck from the medical register. there have since been small outbreaks of measles consequent upon the decreased proportion of vaccinations in britain and in canada, and unfortunately many of the general public remain convinced that vaccination can cause autism. infectious diseases can now spread very rapidly, due to the ever-growing number of people who engage in global air travel. this problem is well exemplified by an epidemic of sars (severe acute respiratory syndrome). this began in mainland china in november of , and due to delayed reporting by the chinese authorities it spread rapidly around the world. the who issued a global health alert on april th . fortunately, application of rigid quarantine measures contained the epidemic, with relatively few deaths in north america, and by july th , the who was able to declare that the sars epidemic was over. many of the major epidemics of earlier eras were due largely to poor hygiene-a lack of clean water, poor sewage treatment, and an inadequate control of people who were already infected. although we often assume that these issues have now been resolved, it is important to recognize that in many third world countries supplies of clean water and adequate supplies of food are still lacking, with shortages often exacerbated by ethnic conflicts. the same issues of clean water, waste disposal and burial of the dead could still arise in wealthier countries today if there were to be an earthquake, a typhoon or a tsunami, and emergency services must be prepared to give the highest priority to an early re-establishment of the basic health infrastructure following any natural disaster. issues in the adulteration of food have now been largely overcome in developed society, but the current obesity epidemic underlines that problems still have to be resolved in terms of persuading food processors to avoid tactics designed to persuade consumers to overeat. for those who can afford housing, the modern single-family home is generally well-equiped to optimize the health of those who are living in it. massive tower blocks are less suited to a healthy and active life-style, particularly for families with young children. moreover, ever-increasing minimum specifications for housing, a growing world population and a lack of land is presenting public health agencies with the issue of a growing proportion of homeless individuals in many large cities. globalization is presenting new challenges to public health, not only with the rapid spread of infections, but also with the international enforcement of regulations on issues ranging from emission controls on cars to the quality of foods and medications. the ideal forum for developing appropriate preventive measures would seem the world health organisation, but unfortunately (as with many international bodies) its effectiveness is often limited by political considerations, including threats from some nations to slash funding unless criticism of their practices is shelved. . are the infrastructure constraints of an earlier era still compromising public health in third world countries? questions for discussion child against measles, mumps and rubella? what will be the likely new challenges to public health agencies over the next years? public health foundations: concepts and practices cigarette smoking: health effects and challenges for tobacco control plague and the poor in renaissance florence principles of water resources bathing in public in the roman world mission and method: the early nineteenth century french public health movement history of hygiene asian medical systems: a comparative study hygiene in the early medical tradition public health victorian medicine and popular culture private choices and public health. the aids epidemic in an economic perspective health, civilization and the state; a history of public health from ancient to modern times the nazi war on cancer housing in urban britain environmental policy and public health: air pollution, global climate change and wilderness a history of public health shephard rj. the risks of passive smoking on the mode of communication of cholera the new public health the establishment of a board of health for new york city in further reading some early societies had an infrastructure that provided clean water and the removal of sewage, but since this was usually available only to wealthy citizens, its impact upon the course of epidemics was limited. major cities such as london did not build a comprehensive infrastructure until the middle of the victorian era, when appropriate initiatives were taken by newly formed boards of public health. although the traditional concerns of public health have now been largely met in developed societies, new challenges are constantly arising. these include the control of tobacco products and mood-altering drugs, the reduction of automotive emissions and other forms of urban pollution, management of the hiv/aids epidemic, overcoming a growing reluctance to vaccinate infants, and countering the rapid spread of infections by air travel. key: cord- -ukz hnmy authors: nan title: poster date: - - journal: j frailty aging doi: . /jfa. . sha: doc_id: cord_uid: ukz hnmy nan background: frail older adults are at increased risk of postoperative morbidity compared with robust counterparts. simple methods testing frailty such as grip strength have shown promising results for predicting post-operative outcome, but there is a debate regarding the most appropriate and precise frailty assessment method. objectives: we compared the predictive value of multidimensional frailty score (mfs) with grip strength or conventional risk stratification tool for predicting postoperative complications in older hip fracture patients. methods: from january to december , older hip fracture patients (age >= years) who underwent surgery and comprehensive geriatric assessment (cga) were retrospectively included for analysis. hip-mfs was calculated based on the cga with component of sex, charlson comorbidity index, serum albumin, koval grade, cognitive function, risk of falling, mini-nutritional assessment and mid-arm circumference. grip strength was also measured before surgery. the primary outcome was a composite of postoperative complications (e.g. pneumonia, urinary tract infection, delirium, acute pulmonary thromboembolism, and unplanned intensive care unit admission). results: among patients (mean age . ± . years, . accordingly, grip strength could be used for screening tool to identify high-risk patients who need for further comprehensive geriatric assessment among older hip fracture patients. information and data suspected of post-operative infections. the diagnostic criteria of infection dealt with grade ii or more of clavien-dindo classification. diagnosis of infectious disease was made with reference to vital sign, blood test, imaging and bacterial test results. surgical site infection (ssi) was evaluated based on the infectious control team surveillance. results: elderly patients were registered with necessary data. the average age was . years, males and females were included. in the sarcopenia evaluation, there were cases without sarcopenia and cases with it. cases developed some infectious complications postoperatively. the types of infectious complications (including duplication) were cases of some surgical site infections including suture failures, of pneumonia, of urinary tract infection, of pneumonia and cases of sepsis in patients. infectious complications occurred in cases in the non-sarcopenia group and in the sarcopenia group (p = . ). the average postoperative hospitalization was . days overall, . in the group with postoperative infectious complications, and . in the group without sarcopenia. conclusion: in this study, there was no relation in the incidence of postoperative infections and preoperative sarcopenia. however, the postoperative hospitalization in the group with postoperative infectious complications was almost tripled. background: hypertension is one of the major risk factors for cardiovascular disease. lowering blood pressure is effective for preventing stroke, heart failure (hf), myocardial infarction and possibly dementia. in france, the prevalence of elderly people treated for hypertension rising leading to a possible increase of potentially inappropriate antihypertensive prescribing (piap) that may cause adverse drug events. objectives: to identify associated factors with potentially inappropriate antihypertensive prescribing (piap) in elderly people. methods: we conduct a retrospective observational study based on a cohort from geriatric day hospital for assessment of frailty and prevention of disability in toulouse, between january and april . piap was defined with several explicit criteria: the european list of potentially inappropriate medications, alert and control of iatrogenesis (aci) criteria by the french health authority, the french society of hypertension guidelines, screening tool of older people's potentially inappropriate prescriptions (stopp) version two and summary of product characteristics. the piap has been considered as a binary variable (logistic regression) then as a counting variable by number of nonconformities on antihypertensive drugs (negative binomial regression). results: among the patients, % had piap. frailty, polypharmacy, history of angina and hf are associated with a higher risk of piap. similarly: frailty, polypharmacy and history of angina are associated with an increase in the number of non-conformities antihypertensive drugs. analysis of subgroup of patient hf -piap indicated that % had aci criteria whose % the aci criteria " antihypertensive drugs or more" and % the aci criteria " diuretics or more". analysis of subgroup of patient history of angina -piap indicated that % had stopp criteria, focused on loop diuretics. conclusion: our work suggests that some elderly people characteristics are associated with an increase likelihood of piap. targeting these patients would be beneficial in preventing medicine-related illness. background: social frailty was reported to be associated with age, sex, income, education, marital status, and household status. however, mood status including depression and emotion was relatively less investigated. objectives: the aim of this study is to clarify the association between depression and apathy status and social frailty in community-dwelling japanese elderly. methods: a health promotion project (teng tv project) is designed to distribute health promotion programs including enhancement of nutrition and physical activity via cable tv channel for community-dwelling elders. we ran a cross-sectional analysis using baseline characteristics of all participants (n= ). demographic data, socio-economic status, comorbidities, and nutrition evaluated by mininutritional assessment-short from (mna-sf) were recorded. functional capacity was assessed by the japan science and technology agency index of competence (jst-ic). mood status including depression, and emotion was measured by geriatric depression scale (gds- ) and apathy evaluation scale (aes). social frailty was defined by household status (living alone or not), financial difficulty, social activity, and fulfilment of social needs. we defined total deficit scores of or more as social frailty, as social pre-frailty, and as robustness. we used a linear regression model to analyze the association between mood status and social frailty after adjusting for age, sex, education, marital status, comorbidities, bmi, mna-sf, jst-ic. results: at baseline, mean age of all participants ( . % men) was ± . years. a total of . % and % of all participants were categorized as social prefrailty and social frailty, respectively. the mean scores of gds- and aes were . ± . , . ± . , respectively. in linear regression model after full adjustment, participants with social pre-frailty and social frailty were associated with increased gds- scores (social pre-frailty vs. social robustness: b= . , %ci . - . ; social frailty vs. social robustness: b= . , %ci . - . ) and aes scores (social pre-frailty vs. social robustness: b= . , %ci - . - . ; social frailty vs. social robustness: b= . , %ci . - . ). in addition, jst-ic was also associated with gds- and aes scores. conclusion: social pre-frailty and social frailty were associated with greater level of depression and apathy. future studies are warranted to determine the causal relationship among mood status and social participation. inthira roopsawang , , hilaire thompson , oleg zaslavsky , basia belza (( ) ramathibodi school of nursing, faculty of medicine ramathibodi hospital, mahidol university, bkk, thailand; ( ) biobehavioral nursing and health informatics, school of nursing, university of washington, seatlle, usa) background: frailty is a common geriatric condition with an impact on surgical outcomes. no research has been published on frailty assessment in hospitalized orthopedic patients in thailand. having a valid frailty measure has the potential to improve screening and could enhance quality of care. objectives: to test the ability of the reported edmonton frailty scale-thai version (refs-thai) in predicting hospital outcomes compared with preoperative assessment measures, the american society of anesthesiologists physical status classification (asa) and the elixhauser comorbidity measure (emc) in older thai orthopedic patients. methods: a prospective study was conducted at a university hospital. the hospitalized patients aged years or older scheduled for elective orthopedic surgery were recruited in this study. multiple firth logistic regression modeled the effect of frailty on postoperative complications, postoperative delirium (pod), and discharge disposition, while length of stay (los) was examined by poisson regression. the area under the receiver operating characteristic curve (auc) and mean squared errors (mse) were used to compare predictive ability of the instruments. results: two hundred participants with mean age of (range - years) were mostly female , % were frail, and % underwent knee surgery; of which . % had postoperative complications, . % developed pod, and % were unable to be discharged home. average los was days. adjusting for other variables, frailty was significantly associated with postoperative complications (or = . , p = . ), pod (or = . , p = . ), and prolonged los (relative risk [rr] = . , p = . ). applying the refs-thai alone shows good performance in predicting postoperative complications (auc = . , % ci = . - . ) and pod (auc = . , % ci = . - . ). the combination of refs-thai with asa and emc demonstrates improvement in predicting postoperative complications (auc = . , % ci = . - . and . % ci = . - . , respectively) and pod (auc = . , % ci = . - . and . % ci = . - . , respectively). conclusion: frailty assessment using the refs-thai was useful in predicting adverse outcomes in older adults undergoing orthopedic surgery. integrating the refs-thai for preoperative assessment may be useful for enhancing orthopedic care quality. anthony frioux , matthieu faure , margot de battista , benoit roig (( ) université de nîmes, france; ( ) université de france) background: the attention of the scientific community to frailty has been drawn over the past several years. frailty is defined as a state of increased vulnerability that may lead to functional disability. if this state is managed soon enough it may be reversible. in parallel, the possibilities of monitoring health status through connected objects such as smartphones are increasing. similarly, it is possible to measure the activity of the inhabitants of a house collecting usage data (water and electricity consumption). our project is in the field of smart home and aging monitoring. objectives: therefore, the objective of our work is to develop an integrative model of frailty based on the contributions of existing scientific tools (fried et al., ; mitnitski, mogilner, & rockwood, ) and current sensors to measure a person's activity. eventually, we are aiming for the detection of the frailty trajectory early on. for example, real-time activity monitoring is used to detect a fall and alert rescue. in our case, these sensors will allow us to identify as soon as possible a dimension that would be abnormal in order to intervene and propose an appropriate intervention. methods: our tool will be able to measure the five fried's frailty criteria which are currently used in clinical practice. we compare the data from the sensors with the results of the evaluation of fried's frailty phenotype. results: we expect to obtain a correlation between our data and phenotype results. conclusion: the main contribution of our tool resides in the possibility to observe deviations from an individual's normal aging trajectory. thus, the evaluation we propose would be more ecological as it will enable us to consider the individual's habits and to have a more detailed assessment of his activity evolution. in conclusion, the holistic aspect of our work will allow the practitioners to base their intervention on a wide range of health data. l. van wagenberg, r.m. wösten-van asperen (department of paediatrics, paediatric intensive care unit. wilhelmina children's hospital, utrecht, the netherlands) background: a frail phenotype is recognized in the elderly population. frailty is associated with a higher mortality for adult intensive care (icu) patients. research in oncology suggests biological age is not the key contributor to frailty, since frailty is also found in the younger population. in paediatrics frailty is an unknown concept and as a consequence, the prevalence and meaning of being frail at young age are unknown. objectives: to assess whether a possible frail phenotype can be found in a critically ill paediatric oncological population. methods: a retrospective cohort study in a paediatric oncological icu population between january and september . demographic data and need for icu resources (mechanical ventilation, inotropic support and s continuous renal replacement therapy (crrt)) were collected. since specific paediatric frailty scores are not available, we addressed patients as having a frail phenotype by textmining their electronic health records on the words "fatigue", "cachexia" and "diminished physical activities" before, during, and after paediatric icu admission. risk factors for a possible frail phenotype (cachexia, use of corticosteroids and lowest serum albumin levels) were collected. primary endpoint was mortality during icu treatment or course of illness. results: admissions were included, of which admissions had a possible frail phenotype. these admissions included unique patients. % of patients was male and the median age was years (iqr - ). patients were predominantly treated for a haemato-oncological malignancy ( %). mortality during icu-admission was %, and % died subsequently during the course of disease after picu discharge. patients were severely ill, with a mean icu length of stay of . days (± ), % on ventilator support, % receiving vasopressor or inotropic support, and % on crrt. loss of muscle function or fatigue was present in % before icu admission and in % acquired atrophy or cachexia was documented during icu treatment. % were treated with corticosteroids during picu stay. in % a serum albumin ≤ gram/dl was measured. conclusion: a possible frail phenotype is present in the oncological patient population of a paediatric icu. more research on the contributing factor of frailty on outcome of these patients is needed in the near future. john muscedere , , amanda lorbergs , jayna holroyd-leduc , anik giguere , leah gramlich , heather keller , ada tang , danielle bouchard , donna fitzpatrick-lewis , , diana sherifali , (( ) canadian frailty network, kingston, on, canada; ( ) queen's university, kingston, on, canada; ( ) university of calgary, calgary, ab, canada; ( ) laval university, quebec city, qc, canada; ( ) background: despite research evidence related to nutritional and physical activity interventions, there is a gap in provision of evidence-based care focused on preventing and managing frailty among older adults. objectives: to systematically generate evidence-based nutrition and physical activity (pa) clinical practice guidelines to improve health and functioning in older adults with or at risk of frailty. methods: we are using the agree ii guideline development protocol to generate guidelines to improve health and functioning in older adults. for each guideline, systematic review of meta-analyses was conducted by searching three databases for english language citations published since that included adults aged y and older with frailty and/or pre-frailty. nutrition or pa interventions with a comparison group were considered eligible. acceptable study designs included rcts, quasi-experimental trials, and observational cohorts with a comparison group. in a face-to-face meeting with multidisciplinary content experts, healthcare professionals, and end-users we will further appraise the quality and strength of the evidence using the grade approach. this group will use this evidence to form recommendations related to nutrition and pa in this population. results: the nutrition and pa searches resulted in and citations, with and eligible for full-text review, respectively. the results will inform guideline recommendations. knowledge translation strategies will be developed to support guideline dissemination and implementation. conclusion: the guidelines will inform health professionals by providing evidence-based nutrition and pa interventions for adults with frailty. ( background: physical and psychosocial factors play important roles in the severity and progression of frailty. frailty screening tools include measures of the more common risk factors, including advanced age, comorbidities, poor diet, weight loss, lower socioeconomic status, and physical inactivity. however, there has been limited standardization in the us on specific frailty screening measures to include in national health surveys or frailty tools/protocols for community health settings. this makes it difficult to monitor frailty incidence/prevalence in the older adult population and to best identify and treat individuals at risk. results: we reviewed the most recent versions of us national health surveys that include older adults, to identify whether frailty screening measures were included in. no national surveys had a battery of measures that would allow for frailty risk screening. most commonly, questions on weight, disability, mental health, physical functioning were included. however, physical functioning measurements such as grip strength or gait speed, measured height and weight, unintentional weight loss, dietary intake or appetite changes were not. further, we used the world health organization criteria for effective community screening programs to review published evidence of the validity, reliability, and feasibility of data-driven screening tools for frailty risk among community-dwelling older adults. of the frailty screening tools reviewed, the frail scale was identified as the most promising, based on test characteristics and cost/ease of use. more community-level s research is recommended, particularly on predictive validity of favorable outcomes following physical activity/nutritional interventions. finally, because nutrition plays a significant role in frailty risk, we surveyed registered dietitian nutritionists who work with older adult populations (n= ) to identify their awareness/use of frailty screening protocols/tools and dietitians' potential role in frailty screening. dietitians practicing in the community recognized a potential role, but few dietitians were aware of (< %) or using (< %) specific frailty screening tools. conclusion: future opportunities to better support healthy aging include: addition of frailty screening measures to national health surveys to help prioritize high-risk populations, conduct additional research to validate/recommend a common community-level screening tool, and promote engagement by dietitians and other health professionals who can establish protocols for community-based frailty screening. ming-yueh chou , , ying-hsin hsu , yu-chun wang , chih-kuang liang , , li-ning peng , , liang-kung chen , , yu-te lin (( ) center for geriatrics and gerontology, kaohsiung veterans general hospital, kaohsiung, taiwan; ( ) aging and health research center, national yang ming university, taipei, taiwan; ( ) department of geriatric medicine, national yang ming university school of medicine, taipei, taiwan; ( ) center for geriatrics and gerontology, taipei veterans general hospital, taipei, taiwan) background: older people with frailty are at risk of adverse outcomes, such as falls, functional decline and mortality, and multi-domain intervention program may prevent those. objectives: the purpose of this study is to evaluate the effectiveness of multi-domain intervention program among those community-dwelling frail older people in southern taiwan. methods: a week multi-domain intervention program were provided for all participants, including physical activity, high protein diet education, medical knowledge education and cognitive simulation activity for hours per week. comprehensive geriatric assessments were performed before and after the intervention program, including basic demographic data, risk for malnutrition (by mna-sf), mood condition (by gds- ), cognitive condition (by mmse) and frailty status according to the definition by the cardiovascular health study (chs) . results: during jan and may , totally participants were invited for study ( . % female, mean age . ± . years). among them, ( . %) were clarified as frailty status and ( . %) as prefrailty status. after the multi-domain intervention program, their mood condition ( . ± . to . ± . , p< . ) and cognitive condition ( . ± . to . ± . , p< . ) improved significantly. in addition, the walking speed ( . ± . to . ± . m/s, p< . ) and physical activity ( . ± . to . ± . mets/week, p< . ) improved, but not handgrip strength (p= . ). for the frailty status, those clarified as frailty status decreased from . % to . % and prefrailty status from . % to . % (p< . ). conclusion: our results showed that through the week multi-domain intervention program, those frail older people could improve their mood condition, cognitive condition, usual gait speed and frailty status. sarah b. lieber , stephen a. paget , , jessica r. berman , , medha barbhaiya , , lisa sammaritano , , kyriakos a. kirou , , john a. carrino , dina sheira , mangala rajan , yingtong lyu , lisa a. mandl , (( ) division of rheumatology, hospital for special surgery, new york, ny, usa; ( ) department of medicine, weill cornell medicine, new york, ny, usa; ( ) department of radiology and imaging, hospital for special surgery, new york, ny, usa) background: frailty is a clinical phenotype that increases with age, but can occur in younger patients with chronic disease. based on few studies, frailty has been found in up to . % of patients with systemic lupus erythematosus (sle) and is associated with increased mortality. whether frailty is prevalent in other sle cohorts and associated with objective and subjective factors is unknown. objectives: we aimed to determine the prevalence of frailty in a prospective cohort of women with sle and whether inflammatory biomarkers, body composition, and patient-centered domains differed between frail and non-frail women. methods: adult women < years old who fulfilled american college of rheumatology sle criteria were recruited from one center. exclusions included pregnancy, dialysis, active malignancy, overlap autoimmune syndromes, and severe sle disease activity. frailty was measured according to fried criteria. patient-reported outcomes (pros) were measured using pro measurement information system (promis) computerized adaptive tests; lupusqol; and disability based on valued life activities. physicianreported sle disease activity and damage indices were collected. inflammatory biomarkers and sarcopenia according to dual-energy x-ray absorptiometry were assessed. differences between frail and non-frail women were evaluated using chisquare tests and kruskal-wallis tests; the association between frailty and disability was determined using logistic regression. results: women enrolled from / - / . despite age under years old, % were frail. frail women had greater disease damage (p= . ) and were more often smokers (p= . ). high-sensitivity c-reactive protein (p= . ) and interleukin- (p= . ) were higher and sarcopenia trended toward greater prevalence (p= . ) in frail women. significant differences in promis mobility, physical function, pain interference and behavior, and fatigue and lupusqol physical health and pain (all p< . ) were observed between frail and non-frail women, with frail women reporting consistently worse scores. frail women were . x more likely to be disabled than non-frail women, including after adjustment for age, comorbid conditions, and disease activity/damage. conclusion: the prevalence of frailty was high in this cohort of mid-aged women with sle. frail women had poorer health-related s quality of life than non-frail women, including substantially higher disability. if frailty is associated with worse health outcomes, it could be a potential therapeutic target. chariya sumcharoen, supreeda monkong, nuchanad sutti (ramathibodi school of nursing, faculty of medicine ramathibodi hospital, mahidol university, bangkok, thailand) background: bed bound older adults need caring of physical activities, mental, mood, and social from family caregivers. family caregivers usually gets the role strain from caregiving. there are many factors associate with the caregiver role strain but have been rarely reported in bed bound older adults at home. objectives: the study examined age, adequacy of incomes, mutuality, health status, preparedness, and social support influencing caregiver role strain from caregiving activities for bed bound older adults at home. methods: caregiver role strain concept by archbold and colleagues with literature review were used to guide this study. the sample was recruited by purposive sampling consisted of caregivers aged years or older, who have cared for bed bound older adults at home in thailand. data were collected by structured interview using the questionnaires including demographic data, preparedness, health perception, mutuality, social support, and caregiver role strain from the care activities. data was analyzed using descriptive statistics, pearson's product moment coefficients, and multiple regression analysis. results: the most of participants were women ( . %), age ranging from to years (m= . , sd= . ) . the result showed that age, adequacy of incomes, mutuality, health status, preparedness, and social support jointly significantly explained . % of the variation in caregiver role strain from caregiving activities. the regression effects were strongest for health status (beta=-. , p=. ), followed by preparedness (beta=-. , p=. ), age (beta=. , p=. ), and adequacy of incomes (beta=-. , p=. ) respectively. conclusion: this finding suggests that healthcare providers should find strategies for promoting health status and preparedness of family caregivers for decrease caregiver role strain from caregiving activities. of life, and hospital admissions. objectives: we estimated the prevalence and describe the characteristics of the population with recurrent falls and fear of falling and their association with frailty, physical performance and cognitive fragility. methods: data came from the "salud, bienestar y envejecimiento" (sabe) colombia study, a cross-sectional study conducted in at the urban and rural research sites ( municipalities) in colombia. sociodemographic, health, cognitive and anthropometric measures were collected from community-dwelling adults aged years and older, representative form the total population. frailty was defined using the frailty phenotype proposed by fried. cognitive frailty was defined using the inaa/iagg consensus definition. low performance was evaluated with sppb (short physical performance battery). logistic regression analyses were used to identify factors associated with recurrent falls and fear of falls. results: our study identified elderly who had recurrent falls and fear of falling ( . % and . % respectively). young elders (≤ years) had more falls and greater probability for fear of falling compared to older ages. sex had no significant differences. the factor associated with an increased risk of recurrent falls and fear of falling in the elderly were low physical performance, fragility and polypharmacy. chronic illness such as osteoarticular disease, mental disease, diabetes and chronic pulmonary disease were significantly associated with recurrent falls and fear of falling. finally, when adjusted for age, sex, sociodemographic factors and comorbidities in a logistic regression model, frailty was associated with fear of falling and recurrent falls, while cognitive frailty and low physical performance only were associated with fear of falling. conclusion: recurrent falls have a significantly association with frailty. there are cognitive, physical performance and clinical factors associated with fear of falling that could be preventable and treatable. rubbieri gaia , ceccofiglio alice , mazzeo nicla , pupo simone , cartei alessandro , rostagno carlo , mossello enrico (( ) department of perioperative medicine, careggi hospital and university of florence, italy; ( ) department of geriatric medicine, careggi hospital and university of florence, italy) background: the prevalence of frailty in patients with hip fracture is high, but little is known about the choice of the best frailty tool in terms of prediction of functional recovery. objectives: the aim of this preliminary study was to determine the most predictive validated frailty tool in older people with hip fracture and to determine whether frailty can predict functional recovery during the hospital acute phase. methods: this study was observational prospective cohort study. participants aged + admitted to hip fracture units in florence, were assessed pre surgery (t ), and post surgery. each participants underwent a comprensive geriatric assessment and frailty was defined using: clinical frailty scale (csf), frail scale (fs), reported edmonton frail scale (refs), postal frailty screening (pfs). the outcome was functional recovery, evaluated by a score of postoperative performance on the cumuleted ambulation score (cas). data recorded included pre-recovery barthel index (bi), charlson comorbidity index (caci), handgrip strenght test (hg), asa score, mini nutritional assessment short-form (mna-sf), delirium. results: sample included patients (mean age ± years, female . %). cfs was the most predictive frailty tool, with a % sensitivity and a % specificity (auc = . , cut off > ). dividing the sample according to premorbid bi, while bi itself had the highest predictive value when premorbid level was < %, cfs was the best predictor of functional outcome in the %+ subsample (auc= . ). conclusion: frailty defined by cfs can predict short-term functional recovery during acute phase following hip fracture. this appears particularly relevant for subjects with a higher pre-morbid functional independence. s % were women. individuals had data for all five frailty measures. nine percent of participants were non-frail by all instruments, % were frail by all measures and thus % had discordant frailty measurements. % were frail by at least one measure method. the prevalence of frailty ranged from % to % for the different measures. those classified as frail by cfs and non-frail by bp were more likely to be men, be co-living, have lower cognitive function and a higher dependency in iadl compared to those classified as frail by bp and non-frail by cfs. conclusion: frailty measures cannot be used interchangeably. specifically the cfs might not identify physical frail women, with high cognitive ability who lives alone. factors contributing to the heterogeneity of groups classified as frail by different measures need to be further explored. background: polypharmacy is increasingly common amongst older, multimorbid adults. in these individuals, studies have shown a high prevalence of frailty. identification of frailty can be performed using comprehensive assessments registering accumulation of deficits like in the frailty index, or using single-trait markers of frailty like gait speed and handgrip strength. polypharmacy is recognized as an independent risk factor for the development of frailty, and the subgroup of psychotropic drugs may be particularly important in the development of this syndrome. objectives: our objectives were to study the relationship between the total burden of polypharmacy on frailty status using three different measurements of frailty, and specifically the influence of psychotropic drug use on frailty status. our overall aim was to explore whether either of these could be used as independent predictors of frailty. methods: we used data from a -year follow-up study of older people living in the community and receiving home care nursing, i.e. the cascade-study. data collection was completed in june . all participants were aged > years (mean years). a item frailty index was calculated based on results from a comprehensive geriatric assessment performed in the patients' own home. a fourmeter gait speed test was performed, as well as measurement of handgrip strength. information on regular medications was collected from the patients if they administered own medications, or from the home care nursing service if they were responsible for administering the patients' medications. psychotropic drugs were selected based on beers criteria. results: we found a significant association between the use of psychotropic drugs and frailty index, and frailty index increased by . for each psychotropic drug added (p< . ). one additional psychotropic drug decreased gait speed by , m/s (p< , ). there was no statistically significant association between psychotropic drug use and handgrip strength. conclusion: our study showed that psychotropic drug use was a significant predictor of increased frailty index and reduced gait speed. this was not the case for handgrip strength in our material. laetitia beernaert , frédéric schuind , sandra de breucker (( )department of geriatrics, hôpital erasme -université libre de bruxelles, belgium; ( ) department of orthopedics, hôpital erasme -université libre de bruxelles, belgium) background: anemia is a condition whose prevalence might reach % in the geriatric population. anemia and frailty are two prognostic factors for patients admitted for a hip fracture. objectives: we analyzed retrospectively if preoperative frailty and anemia were independently predictive of postoperative complications and mortality in old patients admitted for hip fracture. methods: ninety-seven patients above years old have been admitted for urgent surgery for a hip fracture during and . we excluded patients with a pathological fracture or fractures due to high energy trauma. preoperative anemia was defined as an hemoglobin level under g/dl for women and g/dl for men. frailty was assessed with the isar (identification of seniors at risk) score. results: seventy-five percents of patients were considered as frail (isar score> ). the prevalence of preoperative anemia was %. we found no statistically significant correlation between anemia and frailty (r = - . -p = . ). in multiple regression logistic analysis, the only independent parameter associated with anemia was the presence of comorbidities (or . ( . - . )-p = . ), and the only parameter associated with frailty was the presence of malnutrition (or . ( . - . )-p = . ). neither anemia nor frailty was associated with postoperative complications and mortality. conclusion: preoperative anemia and frailty are not interrelated in patients admitted for hip fracture. anemia is associated with comorbidities, but not postoperative mortality. frailty is associated with preoperative malnutrition. the isar score may not be ideal to screen for frailty in old patients admitted for hip fracture, an item being attributed to the current loss of autonomy. settings. m martinez , maria montoya , , davide angioni , lizeth canchucaja , natalia ronquillo , maria luz gallego , claudia bejar , emmanuel gonzalez , olga vazquez , anna renom (( ) institute de viellisement toulouse, france; ( ) hospital del mar, barcelona, spain; ( ) hospital de terrasa, barcelona, spain; ( ) parc tauli, barcelona, spain) background: frailty is a common critical geriatric syndrome which has been associated with poor health outcomes.a wide variety of frailty indices (fis) have been developed. frail-vig («vig» is the spanish/catalan abbreviation for comprehensive geriatric assessment).it contains simple questions that assess different deficits. it has been inspired by the rapid geriatric assessment. objectives: the aim is to compare the prediction capacity of clinical rockwood index frailty (rif) and frail-vig index (vif) for poor health outcomes (pho) defined as: emergency department visits and/or hospital admission and/or mortalityamong elderly patients. methods: a retrospectiveobservational study was conducted with a followup up to months or pho occurred. patients were admitted in acute geriatric unit care and geriatric day hospital at hospital del mar; barcelona; spain during august and march . the inclusion criteria were the admission ones. frailty was measured at admission. survival analysis was conducted; cox proportional hazards regression was used to build a pho predictive model based on both indexes. best model according to contrast of hypothesis log-rank ,aic; bic and c harrel was selected.diagnoses of the chosen model was done. results: a total of patients were included, mean age was and . % female. the mean of follow-up was . , % patients presented a pho. . % died, % were admitted at emergency department, . % were hospitalized and % presented more than one event.survival curves for frail and non-frail according to pho showed statistically significance for vif (x = . p= . )but not for rif (x = . p= . ). cox proportional hazards regression showed vif hazard ratio . (p= . ) and rif hazard ratio . (p= . ). predictive capability resulted in a model for vif containing cognition and sex, with harrel c of . . as for rif the most parsimonious model rif would be absent and harrel c . . the diagnoses of the model showed time covariate variable test with p= . , p= . , p= . for each predictive variable; squared linear predictor with p= . of and outliners. conclusion: the vig frailty index performed better; compared to rockwood clinical index; in predicting a composite outcome composed by mortality, hospitalization and visits to emergency departments in patients admitted in acute and outpatient settings. after hospital discharge. methods: this study was conducted in the departments of internal medicine and neurology of the university hospital of araba (basque country, spain). participants were >= years, scoring >= on the mmse test and able to stand and walk independently for at least -meter. participants performed twice-weekly moderate intensity group sessions of multicomponent exercise at the hospital during -week, followed by a home-based intervention ( week) . both were focused on balance, aerobic capacity and strength. taking together both interventions, participants completed -week of physical exercise. at the beginning and the end of the program, frailty was measured though fried´s index and sarcopenia with different criteria : muscle strength ( -chair stand), muscle quality (dxa) and physical performance (sppb). we compared the results before and after the intervention by mcnemar test. results: patients ( females, %) were enrolled, were lost to follow-up at the -week time point and people finished the intervention. the intervention decreased significantly the percentage of frail individuals (p< . ) according to fried´s index, and the percentage of people who met sarcopenia criteria for sitto-stand (p= . ) and sppb (p= . ). however, there were no differences in the percentage of people with low appendicular muscle mass. conclusion: our study showed that a multicomponent exercise program is effective for posthospitalization patients because after -week intervention there were significant reductions in frailty and improving results in muscle strength and physical performance. we did not find changes related to muscle mass. references: . background: alcohol addiction can impact every part of the body, including bones. research shows that chronic heavy alcohol use, especially during adolescence and young adult years, can dramatically affect bone health and increase the risk of osteoporosis and bone fracture later in life. objectives: the purpose of this study is to compare data from international scientific literature with data from the study of patients admitted for alcohol dependence, to assess whether there are significant connections between alcohol dependence and unrecognized fractures. methods: we analyzed meta-analysis's studies from the pubmed search engine to evaluate the association between bone fractures with alcohol use disorders. only humans studies from the last years have been analyzed. subsequently, data related to patients admitted for an alcohol rehabilitation cycle were analyzed. results: scientific literature show that there is a close correlation between alcohol abuse and greater frequency of bone fractures. this is partly due to association between alcohol consumption and both osteoporotic fracture and bone density, and partly to the fact that there is an increased risk of falls in alcohol intoxicated patients compared to the general population. patients were considered: % male and . % female. the average age was years. of these , . %, patients, had unrecognized fractures. conclusion: intoxicated patients admitted in alcoholic rehabilitation with recurrent falls anamnesis often did not perform any diagnostic assessment. this is due to the lack of pain perception in the patients or due to family members or emergency physicians who placed the state of drunkenness before any consequences caused by repeated falls. there is an increased risk of unacknowledged fracture in the patients admitted in alcohol rehabilitation this is partly due to the fact that alcohol intoxicated patients often do not perceive the pain and therefore do not investigate any falls that occurred in a state of drunkenness, in part it is due to the damages that alcohol causes on the bone. our data show that alcohol dependence and unrecognized fractures can often be associated. studies in the literature confirms that there is an increased risk of non-cone fractures in patients with alcohol dependence. zamudio-rodríguez, hélène amieva, luc letenneur, karine pérès (centre de recherche inserm u université de bordeaux -isped, bordeaux, france) background: although conceptually distinct, frailty and disability are very common among older adults. both are multifactorial conditions and share some risk factors and pathophysiological mechanisms, such as inflammation or sympathetic-parasympathetic balance alteration. furthermore, each individual component of the frailty phenotype defined by the cardiovascular health study (chs) has been associated with disability in basic and instrumental activities of daily living. objectives: the present study aimed to determine whether pre-frail and frailty are part of the natural history of the disability process. methods: a sample of people aged of the three cities ( c) study in bordeaux were followed for four years. pre-frailty and frailty were defined according to the original phenotype proposed in the chs. disability was defined using the basic (adl) and instrumental (iadl) activity of daily living scales. seven mutually exclusive hierarchical groups were distinguished at inclusion: ) robustness (no frailty or disability); ) pre-frail (without disability); ) frailty (without disability); ) iadl (without pre or frailty or adl) ) pre-frail with iadl (no adl); ) frailty with iadl (no adl); ) frailty with iadl and adl. results: deaths ( . %) occurred during the four years follow-up. compared to the robust group, all other hierarchical subgroups had an increased risk of death, with an increasing gradient: pre-frailty (hr= . ; ic %= . - . ); frailty (hr= . ; ic %= , ) , iadl disability (hr = . ; ic %= . - , ); pre-frailty with iadl disability (no adl) (hr= , ; ic %= , - . ); frailty with iadl disability (no adl) (hr= , ; ic %= . - . ); frailty with iadl and adl disability (hr= , ; ic %= . - . ) were significant after adjustment by age and sex. conclusion: there is a gradual risk of mortality across the different groups ( i.e., ) robust; ) pre-frail; ) frail; ) iadl disability without pre or frailty; ) pre-frail with iadl disability; ) frail with iadl disability; ) frail with iadl and adl disability) thus suggesting a hierarchical relationship. this study could have important clinical implications since pre-frailty and frailty are assumed more effectively reversible conditions in order to interrupt the continuum at the early phase of the disability processes. background: joint replacement provides significant improvement in pain, physical function, and quality of life in patients with osteoarthritis. with a growing body of evidence indicating that frailty can be treated, it is important to determine whether targeting frailty in joint replacement patients is feasible and improves post-operative outcomes. objectives: to examine the feasibility of a preoperative multi-modal frailty intervention (mmfi) compared to usual care in pre-frail/ frail older adults undergoing elective unilateral hip or knee replacements. methods: in this pilot randomized controlled trial (rct), participants who are )>= years old; ) pre-frail (score of - ; (fried frailty phenotype (ffp)) or frail (score of - ; ffp); ) having elective unilateral hip or knee replacement with surgery wait times between - months were recruited from the regional orthopaedic clinic mcmaster university, ontario canada. the mmfi included tailored exercise, protein ( - gm/day), vitamin d ( iu/day) supplementation, and medication review with recommendations sent to family physicians. frailty and mobility were assessed at baseline and -weeks post-operative using ffp, short performance physical battery (sppb) and oxford hip/knee score (ohs/ oks) respectively. results: we recruited and randomized participants between september and may . of those, . % were referred for total hip replacement and . % for knee replacement. the included participants' mean age (standard deviation (sd)) was . ( . ) years; . % were women; . % lived alone, body mass index was . kg/ m ( . ) and . % were former smokers. at the baseline assessment, on the ffp, % were prefrail, % were frail and the sppb was . ( . ). for participants with hip osteoarthritis, ohs mean (sd) was . ( . ) and for participants with knee osteoarthritis, oks mean (sd) was . ( . ). the study recruitment rate was . %, and the retention rate was %. eighty three percent of participants of the intervention group completed the intervention. self-reported adherence to the intervention components was as follow: ) exercise sessions: . %, ) protein supplement: . %, ) vitamin d supplement: . % and ) medication review completion: %. conclusion: this is the first study to examine the feasibility of a multi-modal frailty intervention in pre-frail/frail older adults undergoing joint replacement. this study showed that frailty screening, assessment and management is feasible for older adults undergoing joint replacement in orthopaedic surgery clinics. results have informed the current multi-centre rct to determine effectiveness. christine tocchi , sathya amarasekara , michael cary (( ) school of nursing, duke university durham, nc usa; ( ) school of nursing, duke university durham, nc usa; ( ) school of nursing, duke university durham, nc usa) background: inpatient rehabilitation facilities (irfs) provide intensive rehabilitation therapy to patients to reduce functional impairment, enhance independence and return patients to the community. determination of eligibility for irf is currently based on preadmission screening. subpopulations of older adults may require special consideration in determination of irf admission due to greater risk for poor functional recovery such as those with pre-existing functional limitations and those who are frail. frailty, a pervasive characteristic in older adults with hip fractures has not been examined as a clinical factor influencing discharge destination outcomes in irfs. objectives: ) determine the prevalence of frailty among older adult with hip fracture receiving inpatient rehabilitation; and ) determine the association between frailty and discharge destination among hip fracture patients receiving inpatient rehabilitation. methods: a retrospective cohort study design using cms inpatient rehabilitation facility-patient assessment instrument file. multivariate regression models were performed to examine the association between frailty and discharge destination. frailty status was measured using a frailty index of items with the following cut-off points: - . robust/non-frail; . - . pre-frail; and . or greater as frail. the final sample included , hip fracture patients. results: frailty, pre-frailty, and nonfrail were present in . % (n= ), . % (n= ), and % (n= ) of hip fracture patients, respectively. the majority ( %) of the frail hip fracture patients were discharged home. there were significantly greater proportion of females than males discharged home and those of white race, to years of age, and with higher functional status. regression analysis showed significantly lower functional status at discharge (p < . ) for patients with these characteristics: males, non-white race, and older age. additional factors that influenced discharge destination included: marital status, living in the community prior hospitalization, and length of stay. conclusion: frailty was the most common frailty status on admission to irf. home is the most common discharge destination for all frailty status groups. frailty status could be used to identify hip fracture patients at high risk for adverse outcomes. future studies should be used to explore the potential of frailty to provide valueadded utility to clinical settings such as irfs. background: front-line care providers are seeking direction on how frailty measures may be integrated into existing or future care pathways to enhance the experience of individuals who live with it. multidimensional frailty measures such as the edmonton frail scale offer the potential for case-finding, estimation of severity, and definition of frailty components. objectives: test the feasibility of the implementation of a multidimensional frailty order set into acute care. methods: in , we conducted a literature search to identify existing frailty guidelines and systematic reviews related to frailty in acute care. an expert panel graded the quality the evidence, then generated recommendations, graded by strength to inform the generation of a clinical knowledge and content management (ckcm) topic for dissemination throughout alberta health services (ahs). ahs is the largest province-wide, fullyintegrated health system in canada. this ckcm would include graded statements and recommendations, clinical decision support, electronic alerts, and a frailty order set. results: four guidelines, systematic reviews, and one scoping review informed the development of the frailty ckcm. from this, we developed eight recommendations, covering topics such as prevention, case-finding, estimation of severity, definition of components, triggers for expert assessment, and linkage to care processes. the recommendations also addressed safeguards to avoid labelling and other unintended consequences. an order set employs the clinical frailty scale, electronic frailty index, and edmonton frail scale to support a clinician to develop a personalized care plan. the order set empowers front-line clinicians to administer these frailty measures, based on cut points that prompt personalized recommendations on diet, activity, fall prevention, bladder management, and infusions. depending on the frailty component of concern, clinicians are also prompted with specific options to address cognitive impairment, functional dependence, falls and immobility, social isolation, nutritional risk, polypharmacy, urinary incontinence, chronic pain, and constipation. in preparation for the conversion to a province-wide electronic medical record (emr) in november , the ckcm was released in may and the frailty order set was built into the emr by september . conclusion: development and implementation of a multidimensional frailty order set in the setting of acute care is feasible. masayo kojima , toshihisa kojima , yuko nagaya , yasumoto matsui (( ) national center for geriatrics and gerontology, obu, aichi, japan; ( ) nagoya university, nagoya, aichi, japan; ( ) nagoya city university, nagoya, aichi, japan) background: prevention programs for frailty at community usually target healthy older people. to further prolong healthy life expectancy, we need to approach those who already have got chronic diseases such as rheumatoid arthritis (ra). objectives: the aim of this study is to assess the prevalence and factors associated with frailty in japanese ra patients. methods: ra patients aged - -yearold who visited two university hospitals between march and july were consecutively invited to join the study. those who agreed to participate the study provided written consent forms. frailty was assessed by the total score of the kihon checklist >= . self-report questionnaires were used to evaluate patients' demographic characteristics, perceived degree of pain, depression (the beck depression inventory-ii) and physical function (the health assessment questionnaire, haq). rheumatologists' global assessment of disease severity, swelling and/or tender joint counts, years of ra duration, frequency of arthritis surgery and crp level were also measured. results: total of ra patients were included in the study ( women, average age: . ± . years, average disease duration: . ± . years), and the prevalence of frailty was . %. the higher the age and the longer the duration of the disease, the higher percentage of ra patients with frailty was observed. . % among ra patients of working age ( - years), were frail, whereas . % and . % were frail among those aged - years and >= years, respectively. stepwise logistic regression analysis revealed that age, haq, depression severity and trust in neighbors were independently associated with frailty in ra. no significant gender difference was observed. conclusion: frailty is common even among working age in ra patients. physical function, depression and social capital were suggested to be independently associated with frailty. on-going followup study will disclose the influence of frailty on fracture, dependency, and mortality among ra patients. background: frailty is an important modulator of ageing and might impact on clinical presentation and progression of parkinson's disease. objectives: to evaluate the prevalence of frailty and correlation with motor and non motor symptoms as well as mri atrophy and white matter hyperintensities in parkinson's disease. methods: consecutive parkinson's disease patients underwent a comprehensive motor and non motor evaluation and geriatric assessment using multidimensional prognostic index (mpi). a subset of patients underwent mri with assessment of atrophy and white matter hyoperintensities by visual rating. results: pd outpatients (mean age . y, mean disease duration . years) entered the study. pre-frailty assessed by mpi was presented by % of patients and correlated with age and disease duration. when adjusting for these ariables, mpi correlated with updrs-iii, non motor symptoms assessed by umsar, prevalence of prevalence of orthostatic hypotension, rbd and depression. the mri assessment showed a correlation between global atrophy and frailty indipendently from mmse and educational levels. no association between frailty and wm hyperintensities was found. conclusion: frailty is a possible important modulator of pathology and brain vulnerability in parkinson's disease and could explain different severity in motor and non motor symptoms. longitudinal studies are warrented to evaluate the impact of frailty in disease progression. background: accidental falls in older adults have been associated with worse health-related outcomes especially in the frailest individuals, such as nursing home (nh) residents. in this special population of older adults, falls have been related to greater morbidity and mortality, but their impact on nutritional status is still unclear. moreover, so far there are no data on the potential role of unmodifiable (e.g. cognitive impairment [ci] ) and modifiable factors (e.g. assistance from informal caregivers) in influencing the impact of falls on nutritional status in older residents. objectives: we aimed to evaluate the changes in body weight during the six months after the occurrence of a fall in nh residents, and the possible influence of severe cognitive impairment, depressive symptoms and of the assistance from informal caregivers on such variations over time. methods: the sample included older residents who experienced at least one fall since nh admission. for each participant, we collected data on sociodemographic information, mean frequency of visits from informal caregivers, medical history, and cognitive and functional status at nh admission. severe ci was defined as the presence of a physician-based diagnosis of ci or a mini-mental state examination < points. the frequency of the visits from informal caregivers was categorized as none or (low) vs > (high) per week. falls' date and characteristics were obtained from structured forms completed by physicians. monthly body weight in the six months before and after the fall were derived from the nh medical records based on nurses' assessments. linear mixed models were used to evaluate the body weight changes after a fall, as a function of the presence of severe ci and low visits' frequency from informal caregivers, alone or in combination. results: the mean age of our sample was . ± . years and % were women. more than half ( . %) of residents involved had severe ci and . % had low visits' frequency from informal caregivers. after adjusting for potential confounders, the presence of severe ci (b=- . , se= . , p< . ) and the report of low visits' frequency from informal caregivers (b=- . , se= . , p= . ) were associated with steeper decline in body weight during the six months after the fall. when combining these variables, we found an additive effect of severe ci and low visits' frequency from informal caregivers in influencing weight loss (b=- . , se= . for residents with severe ci and high visits' frequency, and b=- . , se= . for those with severe ci and low visits' frequency; p< . for all). conclusion: our results suggest that cognitive impairment may worsen the impact of falls on nutritional status in nh residents, and that this effect may be exacerbated by scarce assistance from informal caregivers. ( ) tokyo women medical university, tokyo, japan, japan; ( ) department of geriatic medicine, kyorin university medical hospital, tokyo, japan; ( ) tokyo metropolitan institute of gerontology, tokyo, japan) background: in consideration of the future rapid aging of the society, to achieve healthy and active aging is indispensable. because especially the major issue is to prevent "multi-faceted frailty", it is necessary to reconsider regarding nutrition, physical activity and sociality/sociability in the elderly. sarcopenia is associated with adverse health outcomes, such as frailty, limited physical function, falls, disability and loss of independence. objectives: our aim to notice evidencebased new information, leading to frailty prevention, and let the community-based activity by elderly citizen only promote as a voluntary motion in each community. methods: we have already established many new evidences from our on-going japanese large-scale longitudinal study 'kashiwa study'. these evidences include the impact of overlapping of slight oral dysfunction, namely "oral frailty", as well as unbalanced diet and inadequate physical activity in early-stage sarcopenia. furthermore, we found the negative impact of several social disengagements including eating alone, so-called "social frailty", leading to subsequent sarcopenia. we developed a simple screening tool, ''frailty check-up activity'', which elderly citizen supporters only can operate in each small gathering place (e.g. community salon) via support by its local government. results: based on the concept of all-including three pillars, ) nutrition (i.e. dietary food intake including diversity and adequate protein intake, and treatment/maintenance against oral frailty), ) physical activity (not only exercises but also social daily activity) and ) social participation, the newly citizen activity ''frailty check-up'' has developed. after elderly citizen supporters received training fully, they could implement this activity completely and repeatedly in each local municipality. elderly participants could learn how to improve/conquer by themselves with raising their self-awareness for the importance of early frailty/sarcopenia prevention and could change their behavior modification. in addition, using big data combined with preexisting database of new-onset regarding care needs and/or all-cause mortality, we found the new cut-off point in our frailty check-up activity. conclusion: we could confirm that our interdisciplinary "action-research" can raise the citizen's early awareness and affect their behavior modification via elderly citizen supporter system for frailty prevention, consequently leading to extend healthy life expectancy. saguez, carlos márquez, bárbara angel, mario moya, lydia lera (inta, universidad de chile, santiago, chile) background: physical phenotype of frailty has been associated with quality of life deterioration and some studies have calculated cost-effectiveness of interventions on frailty in quality-adjusted life years (qalys), however studies on the direct burden of frailty expressed in qualys lost in community dwelling older adults are scarce. objectives: to forecast qalys lost caused by frailty in older chileans and describe health profiles as determined by euroqol (eq- d) in community-dwelling older chileans with and without frailty. methods: cross sectional study in ( , % women, mean age y± . ) community dwelling people >= years participants in alexandros cohorts. the frailty phenotype was defined as having >= from the following criteria: weak handgrip dynamometry, unintentional weight loss, fatigue/ exhaustion, five chair-stands/slow walking speed and low physical activity. qol was evaluated trough euroqol (eq- d) five dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/depression and self-rated health trough eq -visual analogue scale (eq- d-vas). qualys were calculated by the eq -d time trade-off (tto) method. to estimate life expectancies (le), multistate methods based on the follow-up of alexandros cohorts, were employed. results: frailty was identified in , % of the sample. selfrated health according to eq- d-vas was lower in frail than non-frail people ( . ± . vs . ± . , p< , ). after adjusted multinomial logistic regression, the eq- d dimensions of anxiety/depression (very depressed rrr= . ; %ci: . moderate rrr= . ; %ci: , ) and pain (much pain rrr= . ; moderate pain rrr= . ; had the highest association with frailty. the valorisation of years in qualys was lower in frail than in non-frail people ( . ± . vs. . ± . qalys per year, p< , ) and among those frail, much lower in people >= y than in the group - y ( . ± . vs. . ± . , p< , ). the qualys remaining years were lower in frail people than in non-frail:total le at - y was , y corresponding to , qalys in frail and , qalys in the non-frail; in the group >= y tle was , y corresponding to , qalys in frail people and , in the non-frail. conclusion: the high burden of frailty on qalys, mostly related to pain and anxiety/depression makes compulsory its early detection and treatment. its knowledge allows calculating cost-effectiveness of interventions. background: + agil barcelona is a real-life a multicomponent intervention against frailty implemented in a primary care center, which promotes a comprehensive and coordinated approach between primary care, geriatrics teams and community resources, to detect and reverse frailty in the older adults. objectives: we aimed to assess the -months impact on physical function of +agil barcelona in community-dwelling frail older adults with cognitive impairment. methods: the study population was driven from the +agil barcelona program population. we included participants with cognitive impairment or dementia past history and those who performed a minicog test < points. after frailty screening by the primary care team, a geriatric team performed the comprehensive geriatric assessment. according to cga results, a tailored and specific multidisciplinary intervention for each person was designed. the intervention could include a) multi-modal physical activity (pa) sessions, b) promotion of adherence to a mediterranean diet c) health education and d) medication review. the physical performance was assessed at baseline and at -omths follow-up by the short physical performance battery (sppb) and gait speed. the pre/post intervention analysis was done by a paired sample t-test for repeated samples for continuous variables and chi-square for categorical variables. results: we included participants (mean age= . ± . , . % woman and . % lived alone). despite being independent in daily life, . % had fallen the past year, . % were vulnerable or frail according to the csf. physical performance was impaired: sppb= . ± . and gait sped= . ± . m/sec and . % had balance impairments. after months, . % of participants completed >= . physical activity sessions. the mean improvements were + . ± . points (p< . ) for sppb, + . ± . m/ sec (p< . ) for gait speed, - . ± . sec (p< . ) for chair stand test, and . % (p . ) improved their balance. additionally, psychoactive treatment was withdrawn in . %. conclusion: according to our results, a multidisciplinary and comprehensive geriatric intervention for frail elderly people with cognitive impairment of the community improves physical function and could reverse fragility at months. clarence mwelwa patrick chikusu, amritha narayanan, joel james (ashford and st peter's nhs foundation trust, chertsey, uk) background: frailty and muscle strength are a critical component of walking ability and presence of these can result in high prevalence of falls. it also results in increased morbidity and mortality among the elderly. despite sarcopenia being very common and a reversible condition in its early stage it is a frequently overlooked and undertreated geriatric syndrome a greater understanding of sarcopenia and frailty among healthcare professionals could have a dramatic impact on outcome and quality of life of the elderly. objectives: this study aimed to assess the current knowledge about the concept of sarcopenia and frailty among the healthcare professionals working in an nhs district general hospital in surrey. methods: this longitudinal study included nhs healthcare professionals (n = ) who were asked to complete a questionnaire regarding awareness of concept, risk, diagnostic strategy and management of frailty and sarcopenia. results: . % of healthcare professionals stated to know the concept of sarcopenia, % indicated to know how to diagnose sarcopenia and % had seen patients with suspected sarcopenia in the last one month. only % knew the risk associated with sarcopenia. . % used sarc f questionnaire as diagnostic method for sarcopenia. percent of the cohort experienced bottle necks during the implementation of diagnostic strategy. lack of awareness and time ( . %) was the main reason for this . . percent heard the term frailty and . % knew that sarcopenia and frailty is not the same . . percent was aware of the scoring methods for the frailty and . % used clinical frailty score as the method. . % was aware of the frailty pathway but only . % knew whom to contact regarding managing frailty. . % heard the term comprehensive geriatric assessment. only . % was aware of key recommendations of managing frailty in the acute settings. conclusion: although concept of sarcopenia and frailty is familiar to most nhs healthcare professionals, the practical and clinical application is limited due to a lack of awareness regarding the diagnostic methodology, risks as well as time constrains. as such the benefits and potential treatment options may be overlooked and we aim to improve awareness so that these measures can improve outcomes for patients. mahtab alizadeh-khoei , fatemeh sadat mirzadeh , reyhaneh aminalroaya , fati nourhashemi (( ) gerontology & geriatric department, medical school, tehran university of medical sciences, ziaeian hospital, tehran, iran; ( ) department of internal medicine and clinical gerontology, toulouse, france) background: frailty is a potentially reversible geriatric syndrome associated with geriatric risk factors. detecting risk factors is a useful purpose to predict frailty levels incidence to plan for institutional or home care services. objectives: the aims were finding frail and prefrailty frequency in iranian geriatric outpatients' and determining demographics related factors and geriatric syndrome predictors on frailty levels, based on frailty fried index. methods: in this cross-sectional study elderly >= years old, selected by convenience sampling from geriatric day clinics in the area of tehran university of medical sciences. the effect of risk factors (adl and iadl dependency, obesity, and polypharmacy) and geriatric syndromes (falling, chronic pain, sleep problems, vertigo, vision and hearing impairments, incontinence, dementia, and depression) were evaluated on frailty fried index. predictor factors by logistic regression model were analyzed, according to demographic risk factors and geriatric syndromes. results: the mean age was / ± / years old, majority were male ( %). prefrailty was . % in men and . % in women based on fi. the significant risk factors in elderly prefrail women were depression ( . %), polypharmacy ( . %), visual impairment ( . %), and chronic pain ( . %); although, in prefrail men were vertigo ( . %), falling ( %), sleep disorder ( . %), and incontinence ( . %). in prefrail older adults>= years, only sleep disorder was significant. in logistic regression model, six significant predicted factors were included depression, iadl dependency, falling, chronic pain, vertigo, and age. depression increased the risk of prefrailty by . times, dependency in iadl increased . times; moreover, chronic pain and vertigo increased prefrailty risk about times. dependency on iadl increased the risk of frailty . times, and chronic pain and falling increased the risk of frailty about . times. by logistic regression model, % of prefrail outpatients elderly could be diagnosed. conclusion: geriatric syndromes in outpatients' elderly could predict prefrail more than frail elderly. in the iranian community dwellers prevalence of prefrailty was high, so the on-time screening and outpatients' interventions can help to prevent frailty. background: frailty is a key condition to be screened among elderly oncological patients. nevertheless, the use of the frailty index (fi) in onco-geriatrics is still limited. objectives: aim of our work is to measure the functional and prognostic value for -year mortality of the frailty index (fi) in a cohort of older women with gynecological cancer. methods: the prognostic value of fi was tested in older women with gynecological cancer (mean age = . years). fi was retrospectively calculated following the rockwood model[ ]. spearman's rho test was used for correlations with other oncological scales: eastern cooperative oncology group performance status (ecog); karnofsky performance status (kps); vulnerable elders scale- (ves- ). cox proportional hazard models and roc curve were performed to estimate prognostic role of -year mortality. sensitivity and specificity were also calculated. results: fi is normally distributed and descriptive statistics define our population as frail (mean = . ± . , range . - . ). . is confirmed as an upper limit compatible with life. fi doesn't significantly correlates with age, ecog and kps while it positively correlates with ves- (r= . , p < . ). fi is the strongest predictor for -year mortality confirmed after all adjustments for confounders (or . ; % ci . - . , p < . ) and by roc curve analyses ( . , % ci . - . , p=. ). conclusion: frailty index is a useful tool to detect vulnerability in onco-geriatrics and it predicts -year mortality. it predicts negative health-related outcomes (mortality) better than other traditional scales. its adoption may support a more efficient identification of patients in the need of adapted and personalized care. further studies are needed to confirm and extend these findings. background: frailty has been studied in the old population due to its association with negative outcomes but more information is needed about frailty in very old samples. the fried frailty phenotype (ffp) has been widely used and includes a set of objective indicators: weakness, slowness, unintentional weight loss, exhaustion and low physical activity. objectives: to determine which sociodemographic, functional and health-related variables predict ffp in a sample of community-dwelling individuals aged +yrs. methods: data from individuals living in the metropolitan area of porto were considered: sociodemographic information (age, sex, education level, living status), ffp ( - ), functionality (basic and instrumental activities of daily living), health information (nr. medicines, nr diseases, nr. falls, cognitive impairment, and self-perception of health). descriptive and correlational analysis were conducted and followed by a linear regression analysis (stepwise method) of variables significantly associated with ffp. results: participants' mean age was . years (sd= . ), they were mainly women ( . %), with - years of education ( . %) and living with a relative ( . %). high disability levels were found both for basic and instrumental activities of daily living. the mean of medicines intake was . (sd= . ) and of diseases . (sd= . ); . % of the participants rated their health as poor. the median number of falls in the last year was (iqr= ). participants scored on average . points (sd= . ) in mmse. gender or age were not associated with ffp. basic and instrumental activities of daily living, selfperception of health and cognitive performance significantly predicted ffp. in the adjusted model (r = . ), the stronger predictor was the higher dependency for basic activities of daily living, followed by worst self-perception of health and lower scores of cognitive performance. the dependency for instrumental activities of daily living lost its significance in the adjusted model. conclusion: our results identify three main predictors of ffp (basic activities of daily living, selfperception of health, and cognitive performance) in participants with advanced age. these results provide relevant information for further understanding of frailty and the ffp among the oldest old. background: unplanned hospital readmissions are associated with poorer prognosis and increased risk of functional decline and dependence in older people. identifying major risk factors and assessing clinical risk scores can help to distinguish patients at risk of worse outcomes and rehospitalization, allowing the proposal of preventive measures. the aim of this study was to compare the accuracy of different instruments and risk factors in predicting readmission, functional decline and death in hospitalized older patients in a brazilian geriatric unit. methods: in a cohort study performed at a geriatric unit, patients, years old or over were included. demographic data, functional status, prisma scale, geriatric depression scale, mini mental state examination, timed get up and go test, gait speed, mini nutritional assessment, palmar prehension strength, charlson comorbities index, frailty score of the cardiovascular health study and the senior index risk for rehospitalization were assessed at study admission. all patients received a follow-up telephone call at days after discharge to assess potential readmissions, deaths and functional status. results: mean age was . years (sd +- . ) and the mean barthel adl score was . (sd +- . ). altered barthel ( . ; ci % . - . ; p< . ), chs score ( . ; ci % . - . ; p< . ), isar-hp ( . ; ci % . - . ; p= . ), tgug ( . ; ci % . - . ; p< . ), palmar prehension ( . ; ci % . - . ; p= . ) and gait speed ( . ; ci % . - . ; p= . ) were associated with higher mortality days after discharge. the risk of functional decline at -month follow up evaluation was higher in patients with altered barthel ( . ; ci % . - . ; p< . ), lawton ( . ; ic % . - . ; p= . ), chs score ( . ; ci % . - . ; p< . ), isar-hp ( . ; ci % . - . ; p< . ), prisma ( . ; ci % . - . ; p= . ), tgug ( . ; ci % . - . ; p< . ), palmar prehension ( . ; ci % . - . ; p< . ) and gait speed ( . ; ci % . . ; p= . ). conclusion: altered iadl, frailty chs score, isar, tgug, palmar prehension strength and gait speed are predictive of functional decline and mortality days after hospital discharge. these tools can be useful to pinpoint frailty in older patients, allowing the implementation of preventive interventions to avoid functional decline. more research is needed to evaluate the role of these tools in predicting rehospitalization. to limit the strain on available resources and prevent an unnecessary increase in patient burden. objectives: this study aimed to improve patient selection for multi-disciplinary care by identifying risk factors for disability after cardiac surgery in elderly patients. methods: two-centre prospective cohort study in patients aged >= years undergoing elective cardiac surgery. before surgery frailty characteristics were investigated. outcome was disability at three months defined as world health organisation disability assessment schedule . >= %. multivariable modelling using logistic regression, concordance statistic (c-statistic), and net reclassification index were used to identify factors contributing patient selection. results: disability occurred in ( %) patients. ten out of frailty characteristics were associated with disability. a multivariable model including euroscore ii and preoperative haemoglobin yielded a c-statistic of . ( % ci . - . ). after adding prespecified frailty characteristics (polypharmacy, gait speed, physical disability, preoperative health related quality of life, and living alone) to this model the c-statistic improved to . ( % ci . - . ). net reclassification index was . (p< . ) showing improved discrimination for patients at risk for disability at three months. conclusion: using preoperative frailty characteristics improves discrimination between elderly patients with and without disability at three months after cardiac surgery and can be used to guide patient selection for preoperative multi-disciplinary team care. fabiola valero , , henry tapia , , enrique valencia , , tania tello , , (( ) facultad de medicina, universidad peruana cayetano heredia, lima, peru; ( ) instituto de gerontología, universidad peruana cayetano heredia, lima, peru; ( ) hospital cayetano heredia, lima, peru) background: frailty is increasingly recognized as a risk assessment to detect vulnerability and complexity. currently, there are limited tools to predict adverse perioperative outcomes for the geriatric population with hip fracture. objectives: to determine frailty and functional dependence as predictors of intrahospital adverse events in hospitalized older adults with hip fractures in the orthogeriatric unit of a general hospital in lima, peru. methods: we conducted a prospective cohort involving patients aged years or older who were admitted to the orthogeriatric unit with hip fracture from june to june . data were obtained at the time of admission to our unit: frailty was assessed with the frail scale, function ability with the barthel scale, cognition with the short portable mental state questionnaire (spmsq) scale of pfeiffer, comorbidities, socio-family assessment and geriatric syndromes. patients were followed up to discharge, and adverse events were evaluated during this period. univariate models were performed, and logistic regression was done subsequently. results: patients with hip fractures were evaluated, the mean age was . ( . ) years, . % ( ) were women and . % ( ) came from nursing homes. hypertension was the most frequent comorbidity in . % ( ). % ( ) had a history of functional dependence on basic activities of daily living (abvd), % ( ) had some degree of cognitive impairment, . % ( ) had social problems, polypharmacy in . % ( ) and . % ( ) history of falls in the last year. according to frail scale, . % (n = ) were robust, . % (n = ) were pre-frail and . % were frail (n = ). . % ( ) had an adverse event while hospitalized (pneumonia, uti, delirium, acute renal injury, pet), of whom % ( ) were robust, . % ( ) pre-frail and % ( ) frail (p = . ). . % of patients with functional dependence on abvd presented adverse events. in the multivariate analysis, the factors associated with in-hospital adverse events were functional dependence in abvd, or: . , (ci: . - . ); frailty with an or: . ic ( . - . ) and social problem, or: . ic ( . - . ). conclusion: older adult patients hospitalized for hip fracture who had frailty, functional dependence, and social problems had significant adverse events at a general hospital in lima, peru. aiko inoue , chi hsien huang , , chiharu uno , kosuke fujita , , tomoharu kitada , , joji onishi , hiroyuki umegaki , masafumi kuzuya , (( ) institutes of innovation for future society, nagoya university, japan; ( ) department of community health and geriatrics, nagoya university graduate school of medicine, nagoya, japan; ( ) department of business administration, seijoh university, aichi, japan) background: social frailty was associated with age, sex, income, education, marital status, and household status. however, the risk factors of social frailty relatively less investigated. objectives: the aim of this study is to clarify the risk factors of social frailty in community-dwelling japanese elderly. methods: a health promotion project (nagoya-teng project) is designed to distribute health promotion programs including enhancement of nutrition and physical activity via cable tv channel for community-dwelling elders. of all participants (n= ), participants with complete baseline information (mean age . ± . years, men ( . %)) were included in our cross-sectional analysis. at baseline, demographic data, socio-economic status, geriatric depression scale (gds- ), japanese version of european health literacy survey questionnaire (j-hls-eu-q ) were obtained. social frailty was defined by household status (living alone or not), financial difficulty, social activity, and fulfilment of social needs. total deficit scores of or more were defined as social frailty, as social pre-frailty, and as robustness. results: a total of ( . %), ( . %), and ( . %) of all participants were categorized as social non-frailty, pre-frailty and social frailty, respectively. in multivariable logistic regression model after adjusting for age, sex, bmi, and education level, living without a spouse is a significant risk factor (p< . ) for social pre-frailty (or . , % ci . - . ) and social frailty (or . , ). low gds- scores were associated with high risk of social prefrailty (or . , % ci . - . ) and social frailty (or . , % ci . - . ). in addition, health literacy was inversely associated with social frailty (or . , % ci . - . ). age, sex, and education level were not associated with social frailty. conclusion: regardless of age and sex, living with a spouse and depression which is associated with activity of daily living and quality of life are associated with social frailty. low health literacy is also a risk factor of social frailty. in literature, loneliness and social frailty were associated with functional decline and mortality in the elderly. future approaches incorporating health literacy interventions are warranted to prevent social frailty in the aged society with increasing number of physical frail older adults. background: frailty increases the risk for morbidity and mortality after cardiac surgery. the influence of frailty on postsurgical functional outcomes is largely unknown. objectives: the aim of this research was to study the association of preoperative frailty characteristics on adverse functional outcomes and to investigate the trajectory of functional recovery among frail and non-frail elderly patients up to one year after elective cardiac surgery. methods: a prospective two-centre observational cohort study in elective cardiac surgery patients aged >= years. preanaesthesia assessment was supplemented with frailty tests covering the physical, mental, and social domain. functional outcomes were assessed at one year and included change in health related quality of life (hrql) measured by the short form and disability measured by the world health organisation disability assessment schedule . . adverse functional outcome was considered when worse physical or mental hrql or disability was present after surgery. results: frailty characteristics were present in ( %) patients of whom ( %), ( %) and ( %) showed frailty in the physical, mental or social domain respectively. adverse functional outcome at one year after surgery occurred in ( %) patients. patients with an adverse functional outcome were more often frail ( ( %)) than patients without an adverse functional outcome ( ( %) p< . ). worse physical or mental hrql occurred in ( %) and ( %) patients respectively. the most important frailty characteristic associated with worse physical hrql was high preoperative physical hrql (β - . per point ( % ci - . to - . ). preoperative mental hrql showed the strongest associations for worse mental hrql (β - . per point ( % ci - . to - . )). disability was reported by ( %) patients and associated with preoperative polypharmacy, gait speed, health related quality of life, living alone or dependent living. gait speed had the strongest association (β . per second ( % ci . to . )). conclusion: preoperative frailty characteristics were common and predictive for adverse functional outcome one year after cardiac surgery. frailty screening can be used to improve risk stratification and decision making in older cardiac surgery patients. background: frailty frailty has many elements and these can be characterised as physical, nutritive (including body composition), cognitive and sensory (including hearing and seeing). the relative prevalence and importance of these elements are not known. objectives: to estimate the prevalence of frailty and relative contribution of physical/ balance, nutritive, cognitive and sensory frailty to important adverse health states (falls, physical activity levels, outdoor mobility, problems in self-care or usual activities, and lack of energy or accomplishment) in an english cohort. methods: analysis of community-dwelling older people. the sample was drawn from a random selection of all people aged or more registered with general practices across england. data were collected by postal questionnaire. frailty was measured with the strawbridge questionnaire. we used cross sectional, multivariate logistic regression to estimate the association between frailty domains and adverse health outcomes. some models were stratified by sex and age. results: mean age of participants was years (sd . ), range to and . % ( / ) were men. the prevalence of overall frailty was . % ( / ) and there was no difference in prevalence by sex (odds ratio . ; % confidence interval . to . ). sensory frailty was the most common and this was reported by more men ( / ) than women ( / ; odds ratio for sensory frailty . , % confidence interval . to . ). men were less likely than women to have physical or nutritive frailty. physical frailty had the strongest independent associations with adverse health states. however, sensory frailty was independently associated with falls, less frequent walking, problems in selfcare and usual activities, lack of energy and accomplishment. conclusion: physical frailty was more strongly associated with adverse health states, but sensory frailty was much more common. the health gain from intervention for sensory frailty in england is likely to be substantial, particularly for older men. sensory frailty should be explored further as an important target of intervention to improve health outcomes for older people both at clinical and population level. background: it live independently. our goal is to encourage independent living, wellbeing and to relieve health and care services budget pressure. longevity is one of the biggest achievements of modern societies. by , a quarter of europeans will be over years of age. combined with low birth rates, this will bring about significant changes to the structure of european society, which will impact on our economy, social security and health care systems. the most problematic expression of population ageing is the clinical condition of frailty. frailty develops because of age-related decline in multiple physiological systems. it is estimated that a quarter to a half of people over years are frail , and this is set to reach epidemic proportions over the next few decades. while frailty increases, the average amount of health spending increases as well with the frailty level in a range from , to , €/person year, depending upon the frailty status and the setting of care. frailty usually comes along associated with another risk facto; loneliness. then, ageing, frailty and loneliness constitute overlapping conditions submitted to multiple health and care interventions. ecare project aims to deliver disruptive digital solutions for the prevention and comprehensive management of frailty to encourage independent living, wellbeing and to relieve health and care services budget pressure, throughout the implementation of a pre-commercial procurement scheme. pre-commercial procurement is an ideal framework for the delivery of innovative solutions. the ecare network of procurers and the service providers are often on the frontline as new needs emerge. this pcp will allow the procurers to voice out their unmet needs, create a new demand to access sustainable products of higher quality, and develop new applications with lower life cycle costs. the demand and the supply side will work together to co-create and co-design the solutions and validate their functionalities against the specific challenges outlined in the pcp call for tender. this will clearly maximize the engagement of innovation in health and care services. solutions should improve outcomes for frailty in old adults entailing the physical and the psychosocial factors. the target group are the pre-frail/frail old adults with emphasis on those that feel lonely and/or isolated. the project will procure the development, testing and implementation of digital tools/services and communication concepts to facilitate the transition to integrated care models across health and social services and country-specific cross-institutional set-ups, including decentralised procurement environments and collaboration across institutions. objectives: the project objectives are: • newly development easy-to-use and reliable solutions that facilitate early detection of frailty based on the most efficient standards and methods. • improve the understanding of the factors affecting frailty and the feelings of loneliness and isolation, and how they do correlate (e.g.: gender dimension, social context, etc.). • deliver personalised intervention plans taking into account the end-user societal context. • innovative and meaningful means to tackle the feelings of loneliness and isolation. • new approaches to engage patients as active self-managers of their own health. • new technology developments designed and oriented to the target end-user. • and among all, investigate to deliver cost-efficient solutions, affordable to the payers involved. methods: ecare procurers will proactively organize the requirements of the demand for care solutions in a coherent way. the procurers (buyers' group) will assess the solution adequacy to the targets. the preferred partners will contribute with solid knowledge of innovative procurement paths to the innovation procurement tender. the project partners will do this by: • providing a solid and informed base for dialogue between stakeholders by determining a coherent picture of the market state of the art of the sector based on practical experience of customers and suppliers. • enabling a genuine and credible dialogue between the supply-chain and customers to determine the practical policy and procurement actions required to deliver the ecare solutions. • defining the common unmet needs, communicating these to stakeholders and initiating a mobilization plan for a pcp addressing ecare needs. the pcp may be summarized in a series of actions: • convey the relevance of innovation procurement to public procurers: encouraging suppliers to offer novel solutions to address ecare challenges rather than the lowest price solutions. • analyze the state of the art of the market with all potential suppliers, as well as the main problematic and barriers faced in the sector and that need to be overcome a set of actions involving both the supply and demand sides will be carried out: a coordinated first analysis of the state of the art conducted by all project members followed by a coordinated market sounding through all dissemination channels managed by the consortium will be undertaken to spread project results aiming to receive feedback from all key market players. for this, the role of procurers is vital to replicate and stretch the impact of the project. • providing public procurers with procurement know-how to improve public sector procurement efficiency and increase public sector market power by giving support to apply the methodologies of innovation procurement. market sounding will provide an opportunity for engagement and two-way dialogue with innovative companies that can offer solutions and guidance on how to overcome the procurement barriers. • launching an agreed, realistic and validated joint pcp tender. results: the ecare consortium is immerse in a deep process of unmet needs detection. our goal is to be extraordinarily concrete when defining what the end users and the healthcare professionals are willing for. those unmet needs will be critical for the definition of the requirements and uses cases that the it suppliers will have to follow to design the ict solutions. then… what a better way to know their needs that asking them personally? the vision of providing tailored fit solutions and tools to the end users led to the consensus in creating and facilitating focus group sessions across the procurers regions -campania (italy), barcelona (spain), santander (spain) and wroclaw (poland)-. these sessions will be involving end users, health and social care professionals, and it internal departments of the procurers' organisations. -the focus group script for the end users sessions integrates as main topics the specific condition and related symptoms; experiences of services and care provided; experiences of managing condition when progressing rapidly ; needs for symptom management and how these can be met ; integration of it supportive tools in the management of frailty and loneliness. -the professionals are invited to reflect and discuss the topics of common symptoms and actual care model; experiences of monitoring elderly when condition is progressing rapidly; views about the supportive care needs of elderly and caregivers; early integration of the new care in the management of frailty and loneliness; integration of it supportive tools in the management of frailty and loneliness. -the identified and proposed topics for the it staff would be the state of the art of the relation in between it and social/healthcare; state of the art of interventions on frailty and loneliness. all the four procurers were challenged to organize, at least, focus sessions, one with each specific target group. so far, all the procurers already organized and scheduled the sessions that will occur until the end of january. in terms of impact, participants are expected to be involved ( end users, healthcare professionals and it people). all the representative of the procurers reported so far that the participants have been considering the sessions so interesting and useful. in fact, new topics have been put in the table for discussion in all the different sessions, adding more important information for the definition of the unmet needs. the journey of the project so far has been providing very powerful insights and evidences that people and professionals appreciate to be involved and e(motionally) cared. conclusion: ecare will progress beyond the state of the art by approaching older people not just in terms of their diseases but also in terms of physical, cognitive and psychosocial care and support to prevent functional decline, frailty and disability. the project key components to address frailty are those that define also integrated care, with the addition of targeting high risk frail individuals, an enablement attitude and a focus on outcomes most relevant to frail individuals and their caregivers. for these, a multimodal comprehensive system able to provide the most effective care will need to be provided. background: maintaining autonomy as life progresses has become a challenge for the health systems. this objective can only be achieved by moving the axis of health policies and health care practice from the disease to the preservation of functional capacity. objectives: the aim of this study is to design and pilot a model for the assessment and support of functionality for community dwelling older people. methods: a space in which nurse and social worker jointly assess the functional capacity of older people and identify and provide responses to the detected deficits was proposed. this study was performed in osi donostialdea (gipuzkoa, spain). three main tasks were carried out: . definition of the joint assessment procedure of functionality. . identification of the existing resources and community assets to give answer to the identified needs. . piloting the model in a sample of older people. the identified needs and the availability of resources to respond to them were obtained from the pilot phase. results: in the initial version of this integral assessment were included, functional capacity, physical activity, cognitive capacity, sense organs, nutritional status, social assessment and housing and environmental conditions. a total of individuals ( % women; mean age years, sd= . ; barthel index, mean . , sd= . ; % living alone; % without cognitive impairment) were recruited during the pilot. the following needs were identified: personalized workout routines, fine motor skill exercises, visual and efficient diets adjusted to each patient, make sure resources reach the community, promote the use and design of gadgets to assist the needs of basic and instrumental activities of daily living, improve strategies to prevent cognitive function impairment, ease loneliness and avoid or minimize physical and environmental barriers to access home, to walk the streets and, particularly, to use public transport. there were no resources available for all the identified needs. conclusion: this study will allow the development of a model for the integral assessment of functionality for the aged population, based in a multidisciplinary team, a space and a new way of working in primary care. mónica machón - , maider mateo-abad , , mercedes clerencia-sierra , , , carolina güell , , beatriz poblador-pou , , kalliopi vrotsou - , antonio gimeno-miguel , , alexandra prados-torres , , itziar vergara - ( ( ) background: multimorbidity and frailty are often present in older people and are found to be associated to increased risk of adverse health events. it is necessary to improve the knowledge of the characteristics of such populations to design adequate clinical guidelines seeking to avoid or delay the onset of dependence. objectives: the aim of this study was to identify clusters of chronic diseases in robust and frail individuals and compare sociodemographic and health characteristics between these clusters. methods: this was a cross-sectional study based on data from two longitudinal studies. the sample was composed of functionally independent community-dwelling older people with multimorbidity living in gipuzkoa (basque country, spain). information from electronic health records (diagnose diseases and medication) and a baseline assessment (sociodemographic characteristics, functional status, self-perceived health, cognitive status, sight and hearing impairments, history of falls and nutritional status) was used in the analysis. the timed up and go test of physical performance was included as a measure of frailty. multiple correspondence and cluster analyses were performed to identify groups. results: the study population consisted of individuals ( . % women; mean age . years, sd= . ). frail individuals (n= ) were older, had a lower educational level and a poorer health status than robust individuals (n= ). three clusters were obtained in robust (rc , n= ; rc , n= and rc , n= ) and four among the frail individuals (fc , n= ; fc , n= ; fc , n= and fc , n= ). in rc and fc , none of the chronic diseases had a higher prevalence than in rc -rc and fc -fc -fc , respectively. individuals pertaining to rc and fc presented more frequently diseases related to mobility limitation or limb pain compare to the other clusters. higher rates of cardiovascular diseases and risk factors were seen in rc and fc . in frail individuals a new cluster emerged, fc , containing individuals with higher rates of cognitive and eye problems and a clearly poorer health status. conclusion: the findings obtained in this exploratory study may provide insight for the designing of more specific health interventions for older patients with multimorbidity, even though the chronic diseases cluster identified were similar in robust and frail individuals. background: older african americans (oaa) are at high risk for becoming frail in later life. interventions can reverse or delay frailty, yet oaa have largely been excluded from frailty intervention research. many interventions are also time and resource intensive, making them inaccessible to socially disadvantaged oaa. objectives: we present results of a feasibility trial of a low dose frailty prevention intervention among community-dwelling, pre-frail oaa aged + recruited from a primary care clinic between june st and october st . methods: using a -arm rct, participants were assigned to the intervention, which was delivered by an occupational therapist (ot) and comprised of four sessions over four months (an ot evaluation, and sessions on healthy dietary practices, increasing physical activity, and maintaining a healthy lifestyle), or enhanced usual care (publicly available information about healthy lifestyle, home safety, and local elder services). feasibility criteria were set a priori at % for participant retention (including attrition due to death/ hospitalization), % for session engagement, participants/ week for mean participant accrual, and % for program satisfaction. results: participants were % female with an average age of . years, . % of which lived alone and . % lived off of less than k per year. feasibility metrics were met. the study recruited . participants per week and retained % of participants who attended % of scheduled sessions. mean satisfaction scores were %. the treatment also resulted in positive trends in the expected direction in the treatment group for the following outcomes (d = effect size): global health (d = . ), mental health (d = . ), qol (d = . ), social functioning (d = . ), depression (d = . ), and pain reduction (d = . ). descriptively, treatment group participants were also less likely to experience a progression (deterioration) in three frailty status indicators at -months compared to controls: weight lost, walking speed slowness, and grip strength weakness. conclusion: the intervention was feasible to deliver. qualitative findings from exit interviews suggested changes to the program dose, structure, and content that could improve it for future use. background: it is well known that frail patients are potentially most at risk of functional decline following a hospital admission. objectives: to measure the effects of an augmented prescribed exercise programme versus usual care, on physical performance, quality of life and healthcare utilisation for frail older medical patients in the acute setting. methods: this was a parallel single-blinded randomised controlled trial. within two days of admission, older medical inpatients with an anticipated length of stay >= days, needing assistance/aid to walk, were blindly randomly allocated to the intervention or control group. until discharge, both groups received twice daily, monday-to-friday half-hour assisted exercises, assisted by a staff physiotherapist. the intervention group completed tailored strengthening and balance exercises; the control group performed stretching and relaxation exercises. length of stay was the primary outcome measure. blindly assessed secondary measures included readmissions within three months, and physical performance (short physical performance battery) and quality of life (euroqol- d- l) at discharge and at three months. time-to-event analysis was used to measure differences in length of stay, and regression models were used to measure differences in physical performance, quality of life, adverse events (falls, deaths) and negative events (prolonged hospitalisation, institutionalisation). results: of the patients allocated, patients' (aged ± . years) data were analysed. groups were comparable at baseline. in intention-to-treat analysis, length of stay did not differ between groups (hr . ( % ci, . - . ) p= . ). physical performance was better in the intervention group at discharge (difference . ( % ci, . - . ) p= . ), but lost at follow-up (difference . ( % ci, - . - . ) p= . ). an improvement in quality of life was detected at follow-up in the intervention group (difference . ( % ci, . - . ) p= . ). overall, fewer negative events occurred in the intervention group (or . ( % ci . - . ) p= . ). conclusion: improvements in physical performance, quality of life and fewer negative events suggest that this intervention is of value to frail medical inpatients. its effect on length of stay remains unclear. background: to propose a simple frailty screening tool able to highlight frailty profiles, already since the initial screening phase. methods: a -item questionnaire (lorraine frailty profiling screening scale, lofpross), constructed by an experts' working group, was administered by health professionals to participants > years old (n= ) and living at home, in different clinical settings: a primary care outpatient clinic (rural population, n= ), a geriatric day clinic (day-clinic population, n= ) and healthy volunteers (urban population, n= ). a multiple correspondence analysis (mca) followed by a hierarchical clustering of the results of the mca performed in each population was conducted to identify participant profiles based on their answers to lofpross. a response pattern algorithm was resultantly identified in the rural (main) population and subsequently applied to the urban and day-clinic populations and, in these populations, the two classification methods were compared. finally, clinically-relevant profiles were generated and compared for their ability to similarly classify subjects. results: the response pattern differed between the subpopulations for all items, revealing significant intergroup differences ( . ± . positive responses for urban vs. . ± . for rural vs. . ± . for day-clinic, all p< . ). five clusters were highlighted in the main rural population: "non-frail", "hospitalizations", "physical problems", "social isolation" and "behavioral", with similar clusters highlighted in the remaining two populations. identification of the response pattern algorithm in the rural population yielded a second classification approach, with % of tested participants classified in the same cluster using the different approaches. three clinically-relevant profiles ("non-frail" profile, "physical frailty and diseases" profile and "cognitive-psychological frailty" profile) were subsequently generated from the clusters. a similar double classification approach as above was applied to these profiles revealing a very high percentage ( . %) of similar profile classifications using both methods. conclusion: the present results demonstrate the ability of lofpross to highlight frailty-related profiles, in a consistent manner, among different older populations living at home. such scale could represent an added value as a simple frailty screening tool for accelerated and better-targeted investigations and interventions. ( ) homburg/saar/germany, saarland university medical center, neurology, homburg/germany) background: frailty is the most important short and long term predictor of disability in the elderly. no study to date evaluate the impact of frailty on short and long term independently from neurological outcome measures. objectives: the aim of the study was to evaluate whether diagnosis frailty predicts short and long-term mortality and neurological recovery in old patients who underwent reperfusion acute treatment in stroke unit. methods: consecutive patients were older than years who underwent thrombectomy or thrombolysis in a single stroke unit from to . predictors of stroke outcomes were assessed including demographics, baseline nihss, time to needle, treatment and medical complications. premorbid frailty was assessed with a comprehensive geriatric assessment (cga) including functional, nutritional, cognitive, social and comorbidities status. at and months, all-cause of death and clinical recovery (using mrs) were evaluated. results: patients, of whom underwent mechanical thrombectomy and venous thrombolysis (mean age . , - years) entered the study. frailty was diagnosed in out of patients and associated with older age (p= . ) but no differences in baseline nihss score or treatment strategies. at follow-up, frail patients showed higher incidence of death at ( % vs %, p= . ) and ( % vs %, p= . ) months. frailty was associated with worse neurological recovery at month (mrs . + . vs . + . , p= . ) and one year followup (mrs . + . vs . + . ) for free survival patients. conclusion: frailty is an important predictor of efficacy of acute treatment of stroke beyond classical predictors of stroke outcomes. larger prospective studies are warranted in order to confirm our findings. background: frailty becomes increasingly common as adults age and has known associations with activity limitations and injurious falls among older adults. while it is believed that frailer older adults are less socially connected than their more functional counterparts, less is known about the relationship between frailty and social isolation among community-dwelling older adults. objectives: the purpose of this study was to examine associations of frailty indicators on self-reported social isolation risk among community-dwelling adults age years and older. methods: the upstream social isolation risk screener (u-sirs) was developed to assess social isolation risk among older adults within clinical and community settings. comprised of items (cronbach's alpha= . ), the u-sirs assesses physical, emotional, and social support aspects of social isolation. using an internet-delivered survey, data were collected from a national sample of , adults age years and older. participants completed the u-sirs and additional items on sociodemographics and other health risks. theta scores for the u-sirs serve as the dependent variable, which were generated using item response theory. an ordinary least squares regression model was fitted to identify frailty indicators associated with social isolation risk. results: participants' average age was . (± . ) years. the majority of participants was female ( . %) and lived with a partner/spouse ( . %). twenty eight percent of participants reported difficulty walking or climbing stairs, . % reported difficulty dressing or bathing, and . % reported a fall in the past year. higher u-sirs theta scores were reported among males (b= . , p< . ) and those with more chronic conditions (b= . , p< . ). participants who reported difficulty walking or climbing stairs (b= . , p< . ), difficulty dressing or bathing (b= . , p= . ), or a fall in the past year (b= . , p< . ) also reported higher u-sirs theta scores. further, higher u-sirs theta scores were reported among participants who had not left their home in the past three days (b= . , p< . ). conclusion: findings suggest frailer older adults and those with functional limitations may have greater risk for social isolation. this highlights the critical demand for easy-to-administer and practical assessments for frail older adults that identify their social isolation risk and link them to needed resources and services. background: peak expiratory flow (pef) has been linked to several negative health-related outcomes in older people, but its association with frailty is still unclear. objectives: this study investigates the association between pef and prevalent and incident frailty in older adults. methods: data come from community-dwelling participants of the swedish national study on aging and care in kundgsholmen (snac-k), aged >= years. baseline pef was expressed as standardized residual (sr) percentiles. frailty was assessed at baseline and over six years, according to the fried criteria. associations between pef and frailty were estimated crosssectionally through logistic regressions, and longitudinally by multinomial logistic regression, considering death as alternative outcome. obstructive respiratory diseases and smoking habits were treated as potential effect modifiers. results: our crosssectional results showed that the th- th and < th pef sr-percentile categories were associated with three-and fivefold higher likelihood of being frail, than the th- th one. similar estimates were confirmed longitudinally, i.e. adjusted or= . ( %ci: . - . ) for pef sr-percentiles< th, compared with th- th. associations were enounced in participants without physical deficits, and tended to be stronger among those with baseline obstructive respiratory diseases, and, longitudinally, also among former/current smokers. conclusion: these findings suggest that pef is a marker of general robustness in older adults and its reduction, exceeding that expected by age, is associated with frailty development. background: as consistently reported in the literature, muscle strength (ms) decreases at a higher rate than muscle mass (mm) during aging resulting in a decreased muscle quality (mq). loss of mq has been associated with loss of mobility, falls, frailty and an increased risk of mortality. however, the degree of muscle declines is varying throughout the population leading to states: successful, normal or pathological. it has been proposed that healthy life habits such as be physically active, having a healthy diet etc. could reduce the muscle aging decline. thus, identifying if life habits could counteract or maintain muscle quality during successful aging is important to better characterize aging and to intervene more specifically. objectives: the aim of the present study was to identify whether a physically active lifestyle could attenuate the effects of aging on mq. methods: active young were compared to active older men. to be considered active, young and older men need to practice voluntary physical activity at least min/week since yrs. body composition (dxa; mri) and maximum knee extension strength were measured. mq was calculated as the ratio of ms to mm. aerobic capacity (vo max; moxus©) and muscle contractility (emg) were also measured. muscle biopsies were performed to determine fiber typing, size, intermuscular adipose tissue (imat) and intramyocellular lipid content (imcl). results: absolute mm (p< . ) and ms (p= . ) was greater in young participants compared to their older counterparts while mq was similar between them. even if total (p= . ) and type iia (p= . ) fiber size were greater in ya than in oa, muscle fiber proportion, muscle contractility and lower limb fat mass (imat, imcl) were similar between both groups (p> . ). conclusion: mq was similar between younger and older physically active men suggesting that being physical activity may have mitigated the loss of mq with aging and delayed some physiological age-related changes (muscle composition, contractility). i r a t x e e g a ñ a , itxaso mugica , , nagore arizaga , maider ugartemendia , nagore zinkunegi , janire virgala , maider kortajarena ( ( ) and sppb test (p< , ). similar results have been found in other researches. the parameters that have higher influence in cognition are handgrip test (p< , ) and frailty (p< , ). in other investigations, they got the same results; better cognition is related to better physical capacity and less fragility. in regards with functionality, the values of tug test (p< , ) and gait speed (p< , ) are the ones that show stronger relation. in other investigations, they observed that physical state and functionality were related. conclusion: the quality of life, the functionality and moca test are interconnected and the parameters that have the strongest statistical relationship are fragility and physical state. the greater the physical capacity of the older person is, the greater the functional capacity is too and the fragility decreases. in conclusion, the quality of life is better. kazuki kaji , jun kitagawa , takahiro tachiki , naonobu takahira , masayuki iki , junko tamaki , etsuko kajita , yuho sato , jpos study group (( ) national center for geriatrics and gerontology, obu, aichi, japan; ( ) nagoya university, nagoya, aichi, japan; ( ) nagoya city university, nagoya, aichi, japan) background: the skeletal muscle mass index (smi), which is the appendicular skeletal muscle mass (asm) adjusted for height squared (kg/m ), is used to assess skeletal muscle mass. we reported at this conference last year that smi was overestimated by height loss due to aging in elderly women. furthermore, age-related changes in smi were inconsistent with changes in physical function such as grip strength and walking speed. objectives: the purpose of this cross-sectional study was to investigate the effects of height loss on agerelated changes in smi and physical function in japanese women aged or older. methods: this study was part of the / -year follow up survey of the japanese population-based osteoporosis (jpos) cohort study conducted in / . the jpos study was started in . the subjects of the / year follow-up were women (mean . ± . years). we divided the subjects into quartiles based on years of height loss (q : the lowest, q , q and q : the highest). asm was measured by dual x-ray absorptiometry (qdr a, hologic, usa). grip strength, maximum walking speed, and timed up and go (tug) were also measured. results: the mean change in height during the / -year follow-up was - . ± . cm. mean changes in height in q (n= ), q (n= ), q (n= ) and q (n= ) were - . ± . cm, - . ± . cm, - . ± . cm and - . ± . cm, respectively. the trend test demonstrated significant increases in the mean age and smi from q to q . on the other hand, there was a significant decrease in asm from q to q . the mean grip strength and maximum walking speed significantly decreased from q to q . tug results were similar, suggesting that greater height loss led to longer times. conclusion: in japanese elderly women with height loss, asm and physical function decreased with age, but the smi adjusted for height increased. it may be necessary to establish a muscle mass parameter other than smi to investigate the relationship between muscle mass and physical function. kota tsutsumimoto , takehiko doi , sho nakakubo , satoshi kurita , hideaki ishii , hiroyuki shimada (( ) section for health promotion, department of preventive gerontology, center for gerontology and social science, national center for geriatrics and gerontology, aichi, japan; ( ) center for gerontology and social science, national center for geriatrics and gerontology, aichi, japan) background: sarcopenia was defined as decline in skeletal muscle mass and muscle function, leading to serious health problems including disability. the modifiable risk factors of sarcopenia should be elucidated to contribute to develop intervention from sarcopenia. objectives: to examine the association between anorexia of aging and sarcopenia among community-dwelling elderly japanese individuals. methods: population-based, cross-sectional cohort study in japanese older adults was conducted and participants were identified from the database of the national center for geriatrics and gerontology-study of geriatric syndromes. anorexia of aging was assessed via a simplified nutritional appetite questionnaire. handgrip strength and walking speed were tested, and skeletal muscle mass was assessed using a bio-impedance analysis device. subjects with sarcopenia were defined as those who met the criteria of the asian working group for sarcopenia. the association between anorexia of aging and sarcopenia was then analyzed via multiple regression analysis. results: in total, , elderly japanese individuals were evaluated. the prevalence of sarcopenia and anorexia of aging was . % and . %, respectively. in multivariable logistic regression model adjusted for the covariates except for nutritional status such as albumin, anorexia of aging was independently associated with sarcopenia (or: . , % ci: . to . ; p = . ). this significant association remained even after adjusting for all covariates including nutritional status (or: . , % ci: . to . , p = . ). conclusion: anorexia of aging is associated with sarcopenia among japanese older adults. further studies are needed to determine whether a causal association exists between anorexia and sarcopenia. background: low grip strength is consistently associated with higher rates of mortality, disability and other age-related health outcomes, and is a key characteristic of sarcopenia. grip strength has thus been proposed as a general biomarker of ageing. life expectancy in russia is substantially lower than in norway but whether this is reflected in differences in grip strength across adulthood, as observed in previous comparisons of older adults from russia, denmark and england, needs to be established and explained. objectives: we aimed to compare grip strength in norwegian and russian populations by age and gender, and investigate whether any observed differences were explained by contrasts in height, weight, smoking or education. methods: we used harmonised cross-sectional data on grip strength for , men and women aged - years. this comprised participants from the russian know your heart study (n= , ) conducted in the cities arkhangelsk and novosibirsk in - , and from wave of the norwegian tromsø study (n= , ) conducted in - . grip strength was assessed using the jamar+ digital dynamometer in both studies, and the maximum of six measurements (three in each hand) was used. the association between grip strength and covariates was assessed using linear regression. results: norwegian males had stronger grip than russian males at all ages, for example they were an average of . kg ( % confidence interval (ci) . , . ) stronger at age years and . kg ( % ci . , . ) stronger at age years. among women, corresponding numbers were . kg ( % ci . , . ) at age and . kg ( % ci . , . ) at age . adjustment for weight, education and smoking did not affect the results, but height attenuated the between country differences, especially at older ages. among women aged +, differences in height between countries fully explained the differences observed in grip strength. conclusion: norwegian -year-olds had the grip strength of -year-old russians suggesting that russians are ageing more rapidly in terms of muscular strength than their norwegian counterparts. the important role of height in explaining these differences, especially at older ages, suggest contrasts in early life circumstances may be of key importance. eleanor lunt , , paul greenhaff , , adam l gordon , , , john rf gladman , ( ( ) background: frailty is a state of vulnerability to stressors resulting in adverse clinical outcomes including falls and fragility fractures. identifying biomarkers associated with these outcomes may help target interventions. objectives: to compare parameters of body composition, muscle thickness and muscle strength between patients and healthy older and young volunteers. methods: six young ( - years) and older (>= years) healthy female volunteers were recruited by advert from community groups. female patients (>= years) with an acute fragility fracture were recruited from hospital wards and measured during first week of admission (median th day (iqr - )). frailty was determined by the -item frail scale. height, weight, handgrip (jamar dynamometer) and knee extension (lafayette manual muscle tester) were assessed. body composition was estimated using whole body bioelectrical impedance (bodystat quadscan ®). midpoint vastus lateralis (vl) muscle thickness and mid-thigh subcutaneous fat thickness were assessed using ultrasound (mylab gold, esaote biomedica, italy) with a hz linear-array probe. oneway anova and post hoc tukey's test were used to compare end-point measures between groups. results: frailty was significantly more prevalent in the patient group ( % frail, % pre-frail, % robust) than the healthy older group ( % robust, p< . ). the patient group was older ( ± years vs ± years, p< . ) and had more co-morbidities (p< . ). there were no significant differences between the patient and healthy older group in weight, height, bmi, percentage body fat or subcutaneous fat thickness of lateral thigh. vl muscle thickness was lower in the patient group compared to healthy older and young volunteers ( . ± . cm, . ± . cm and . ± . cm respectively, p< . ). the patient group also had lower handgrip strength ( . ± . kg, . ± . kg, . ± . kg respectively, p< . ) and lower knee extension strength ( . ± . kg, . ± . kg, . ± . kg respectively, p< . ). vl muscle thickness associated with muscle strength (knee extension r= . , p< . and handgrip r= . , p< . ) and was significantly lower in the frail compared to pre-frail or robust participants ( . ± . cm, . ± . cm, . ± . cm respectively p< . ). conclusion: female patients presenting to hospital with a fall and fragility fracture have lower muscle thickness in the thigh compared to non-frail older women, despite no difference in other body composition variables. register, health technology assessment, nhs economic evaluation database) were searched from inception to april , . cross-sectional and cohort studies that reported adjusted risk ratios with % confidence intervals (ci) for frailty with serum level of total testosterone, free testosterone, sex hormone-binding globulin (shbg) were selected. a metaanalysis was carried out by using fixed effects and random effects models to calculate the or of relationship between low level of testosterone and risk of frailty. results: the crosssectional study concluded articles, there was statistically significant association between lower level of total testosterone and risk of frailty (or= . ; %ci, . - . , i = %), as well as free testosterone (or= . ; %ci, . - . ,i = % ), the highest level of shbg was no significant associated with the risk of frailty(or= . ; %ci, . , . ; i = %). the prospective cohort studies obtain articles, no significant were found between frailty and low total testosterone and frailty (pool or= . ; %ci, . - . , i = %). conclusion: the meta-analysis indicates that low level of serum testosterone is significantly associated with the risk of frailty in the crosssection studies. however, we found no significant relationship between low total testosterone and frailty in the cohort studies. more research is needed to address the underlying mechanisms to explain this relationship and to determine whether testosterone supplementation is effective for preventing frailty syndrome. background: although frailty and abdominal obesity are known risk factors for disability in older persons, few studies have investigated the interaction between both factors on the association with disability. objectives: to investigate the association of frailty and abdominal obesity with disability in older persons. methods: we used data from , participants ( % men) in the prospective, population-based singapore chinese health study cohort, who were interviewed and examined for frailty, abdominal obesity and disability at mean age of (range to ) years from - . we defined frailty as having three or more features of weak handgrip strength, slow timed-up-and-go test, low energy level, multiple comorbidities, and difficulty carrying out usual activities. we defined abdominal obesity by waist circumference using sexspecific cut-offs, and assessed disability using the lawton instrumental activities of daily living (iadl) scale. we used multivariable logistic regression models to compute the odds ratio (or) and % confidence interval (ci) for the association between frailty/abdominal obesity and disability. results: about . % of participants were frail and . % had abdominal obesity. frailty was associated with increased or ( % ci) of . ( . - . ) for disability. conversely, the or ( % ci) for the association between abdominal obesity and frailty was only . ( . - . ). compared to participants who were neither frail nor abdominally obese, the or ( % ci) for disability was . ( . - . ) in those who only had frailty, and . ( . - . ) in those who only had abdominal obesity. however, participants who were both frail and abdominally obese had markedly increased or ( % ci) of . ( . - . ) for disability; p-value for interaction between frailty and abdominal obesity was . . furthermore, while men who were both frail and abdominally obese had increased or ( % ci) of . ( . - . ) for disability compared to their counterparts who were neither frail nor obese, the corresponding or ( % ci) was much higher at . ( . - . ) in women; p value for heterogeneity by sex < . . conclusion: frailty and abdominal obesity interacted synergistically to increase the risk of disability in older persons, and the combined effect of both factors on disability was much stronger in women than in men. background: as the world's population ages, the prevalence of cognitive impairment associated with age increases exponentially. objectives: objective of this study was to investigate the longitudinal association of physical activity and cognitive function in two deferentl populations; older adults from mexico representing latin america and south korea representing asia. based on two large population-based longitudinal studies. methods: this is a secondary analysis of two surveys, mhas and klosa, designed to study the aging process of adults living in mexico and south korea. participants> were selected from rural and urban areas. here we investigate the longitudinal association of exercise and cognition using the two waves of each study. cross cultural cognitive examination and mini-mental state examinarion were used to analyze the association between physical activity and cognition in mexican and korean older adults. multivariate logistic regression models were used to evaluate the said association. results: in mexico, the prevalence of physical activity was . %, physical active older adults obtained a higher score in ccce ( . ± . ) p-value < . . they also had more years of education ( . ± . vs. . ± . ) p-value < . , had depression ( . % vs. . %) . and consumed less alcohol ( . vs. . ) p-value < . . in korea, the prevalence of physical activity was . %. the physical active group performed better in mmse (- . ± . vs. . ± . ) p-value < . . the no physical active group had a higher proportion of women, less alcohol consumption ( . vs. . %) p-value < . , fewer years of education p-value < . and a higher prevalence of depression ( . % vs . %) p-value . . in the multivariate analysis an independent association was found in the korean population between physical activity and mmse score even after adjusting for confounders ( . ( . ; . ) p value . ). conclusion: physical activity could have a protective effect on the cognitive decline associated with ageing. background: aging is related to the increase of several chronic diseases, such as, osteoarthritis, osteoporosis, diabetes, hypertension and sarcopenia. sarcopenia (progressive loss of muscle mass and physical performance) is related to difficulties in treating other comorbidities, whether pharmacologically or non-pharmacologically. it's important to understand the relations between muscular strength (w), muscular mass and the phase angle (pa) of bioimpedance, in sarcopenic subjects to prescribe more accurate treatments. objectives: to study the relations of skeletal muscle index (smi) with w, pa and the presents of comorbidities (nc) in elderly subjects. methods: a prospective, observational secondary analysis of data from the "the sarcopenia screening and health related issues in the region of algarve", was performed. community independent living elderly subjects were recruited. body composition was measured by bioimpedance (seca analytics ), knee flexion and extension isokinetic strength ( º/sec) (humac norm). a screening questionnaire was used to determine the presence of comorbidities. smi levels were assessed using european working group on sarcopenia in older people cut-off points. results: a total of female and males, were included, mean age , (± , sd). subject were divided into groups according to smi: normal (n= ), moderated impairment (n= ) and severe impairment (n= ). pearson correlation were calculated within each group for w; pa and comorbidities. normal smi level, were correlated to knee extensors w in both legs (right: r= , , p< , and left r= , , p< , ) . no significant correlations were found with pa. moderate smi level: were correlated to knee extensors w in both legs (right: r= , , p< , and left r= , , p≤ , ), and also with knee flexors w (right: r= , , p< , ; left: r= , , p< , ). a moderate correlation was also found in this group with pa (r= , , p< , ). severe smi level: no correlations were found, in this group, with w. a moderate correlation was found with pa (r= , , p< , ). comorbidities did not have any correlations with smi levels. conclusion: our results seem to indicate that isokinetic strength (work) may have in the future a role in understanding sarcopenia, once it is related to smi. also, pa may indicate moderate and severe smi impairment. background: body characteristics as low muscle mass and high fat mass (fm) affect the physical function of older people. physical function is a fundamental component for the performance of daily activities and for the maintenance of the independence of older adults. however, the relationship between body composition and physical performance varies in different studies and still demands further research. objectives: this study aimed to investigate the association of fat mass index (fmi) determined by dual-energy x-ray absorptiometry (dxa) with physical performance in brazilian communitydwelling older adults. methods: a cross-sectional study with a sample of participants aged years and older, living in ribeirão preto, brazil, including both men and women, was conducted. fm was measured by dxa and fmi was calculated as fat mass/height (kg/m²). the physical performance was assessed by the -minute walk test, and walking distance was recorded as the main parameter, considering the distance predicted by sex. the kolmogorov-smirnov test was used to verify the normality of data distribution. the association of physical performance and fmi was analyzed using the pearson's correlation test and statistical significance was set at p ≤ . (two-sided). results: the participants were aged . ± . years, fmi was . ± . kg/m and distance walked was . ± . m. there was a significant negative association (r = - , p = . ) between fmi and distance walked, showing that higher fat mass index is associated with worse performance in the -minute walk test. conclusion: high fat mass index is associated with worse physical performance in brazilian older adults. background: sarcopenia and physical frailty have been shown to be risk factors for mortality and major morbidity in older adults suffering from various forms of cardiovascular disease. ultrasound measurement of quadriceps muscle thickness (qmt) is an emerging biomarker for sarcopenia, which we hypothesized could be conveniently acquired during the routine echocardiographic exam. objectives: to demonstrate the feasibility of measuring qmt at the time of echocardiography, and determine the association between qmt and clinical indictors of frailty. methods: adult inpatients and outpatients undergoing a clinically-indicated echocardiogram for known or suspected cardiovascular disease were recruited for this cross-sectional study at the jewish general hospital. prior to the echocardiogram, trained research assistants measured height, weight, and three clinical indicators of frailty: rockwood's clinical frailty scale, handgrip strength (jamar dynamometer), and bioimpedance phase angle (inbody ). at the conclusion of the echocardiogram, cardiac sonographers blinded to the preceding assessments acquired a biplane image of the anterior thigh midway between the anterior superior iliac spine and knee, and measured qmt as the combined thickness of the rectus femoris and vastus intermedius muscles. a cardiac ultrasound machine and probe were used (ge vivid e /e , . - . mhz probe). results: the cohort consisted of patients, of which had an available measure of qmt. the acquisition and measurement of qmt added - minutes to the echocardiographic exam. the mean age was +/- years with % females. the mean qmt was +/- mm, similar in men and women, with the lowest quintile being < . mm. higher age and lower body mass index were associated with lower qmt. after adjustment for age, sex, and body mass index, qmt was found to be associated with the multivariate composite of frailty indicators (p< . ), particularly with the clinical frailty scale (beta - . per mm; ci - . , - . ) and bioimpedance phase angle (beta . per mm; ci . , . ). additional adjustment for heart failure and inpatient status did not alter results. conclusion: qmt can be efficiently measured during a routine echocardiographic exam and can add incremental insights about frailty in a diverse group of patients with cardiovascular disease. background: frailty is a clinical syndrome whose signs and symptoms are predictors of health complications, making this a major public health problem. objectives: this study aims to evaluate the prevalence of frailty, in communitydwelling older adults enrolled in a physical exercise program in the north region of portugal, based on fried's phenotype, its association with other variables. methods: in this crosssectional analysis, we used data from individuals who were enrolled in physical exercise programs. gender and age standardized prevalence and the association between frailty and sociodemographic (age, gender, marital status, education, shortage of money) physical (self-perceived health, polypharmacy, physical fitness, vision, hearing), cognitive (memory), social (emptiness, loneliness and abandonment) and psychological (depression and anxiety) variables were evaluated. results: of the participants, the mean age was . ± . years old, and . % were female. prevalence of pre-frailty and frailty were of . % and . %, respectively. from the fried's phenotype criteria, exhaustion is the most common reported by . % of the pre-frail and . % of the frail participants. age, marital status, self-perception of health, physical fitness, memory and depression were found to be independently associated with pre-frailty, while age, education, self-perception of health, physical fitness and anxiety were independently associated with frailty. conclusion: we reported lower prevalence of pre-frailty and frailty compared with other studies, showing that physical exercise may delay the progression of frailty. interventions aimed to prevent frailty must address the diversity of the associated variables. background: frailty is related with ethnicity and impaired physical capacity which is also affected by diabetes. however, little is known about how physical health indicators of frailty are associated with each other in older hispanics with diabetes. objectives: the goal of this study was to investigate the relationship between physical health indicators of frailty in older hispanics with diabetes. methods: thirty-eight older hispanics with diabetes ( women, men, age = ± years) participated in the study. the variables included age, weight, body mass index, body composition (% of muscle mass and body fat -bio-impedance), fear of falls (falls efficacy scale international -fes-i), chair stands in sec, grip strength (jamar® dynamometer), balance with eyes open and closed (force plate), preferred walking speed, gait velocity during regular and reduce time street crossing simulations (gaitrite®). results: characteristics: body mass = ± kg, % of muscle mass = ± %, % of body fat = ± %, fes-i score = ± points, chair stands = ± repetitions, grip strength = ± kg, center of pressure area with eyes open = ± cm and with eyes closed = ± cm , preferred walking speed = ± cm/s, gait velocity during regular = ± cm/s and during reduced time street crossing = ± cm/s. there were significant correlations (*p< . , **p< . ) between age and gait velocity during regular street crossing (r = - . *); grip strength and % of body fat (r = - . **) and % of muscle mass (r = . **); chair stands and preferred walking speed (r = . **), gait speed during regular (r = . **) and during reduced time street crossing (r = . **) and center of pressure area with eyes closed (r = - . *), and between fear of falls and center of pressure area with eyes closed (r = . **). conclusion: gait speed during street crossing simulations decreased with age. greater grip strength was associated with lower % of body fat and higher % of muscle mass. people who completed less chair stands in s also walked slower and had worse balance, and those with poor balance had increased fear of falls. britta c arends, lisa verwijmeren, peter g noordzij, douwe h biesma, leon timmerman, eric pa van dongen, heleen j blussévan oud-alblas (st. antonius hospital -nieuwegein, netherlands) background: chronic pain after cardiac surgery is common and has a negative impact on quality of life. frailty is an important risk factor for adverse surgical outcomes. the influence of frailty on chronic pain after cardiac surgery is unknown. objectives: this study aimed to address whether frailty characteristics were associated with chronic pain after cardiac surgery in an older population. methods: this study was based on the anesthesia geriatric evaluation (age) and quality of life after cardiac surgery study, which included patients >= years undergoing elective cardiac surgery. preoperatively, frailty was tested in physical, mental and social domains. pain was evaluated with the short form questionnaire (sf- ) preoperatively and one year after surgery. multivariate logistic regression was used to investigate the association between frailty and chronic pain. change in health related quality of life (hrql) was analyzed to evaluate the impact of chronic pain. results: ( %) patients were included in the analysis. / patients ( %) reported new or increased pain one year after surgery. in patients ( %) at least one frailty characteristic was present and patients ( %) were frail in two or more domains. after adjustment for possible confounders in multivariate analysis, patients with single status and polypharmacy were at increased risk for new or increased chronic pain (aors . ( % ci . - . ) and . ( % ci . - . ). new or increased chronic pain was associated with a worse hrql (aor . ; % ci of . - . ). conclusion: frail patients are at risk for chronic pain and worse hrql after cardiac surgery. future research should focus on perioperative interventions to reduce chronic pain in elderly patients. background: frailty is a vulnerability state that is associated with negative outcomes such us falls, in-hospital admissions and mortality. many factors can contribute to the pathogenesis of frailty and nutritional status is playing and important role. that´s why undernutrition and frailty must be overview in older adults before surgical procedures in order to treat them earlier. objectives: identify the relationship between physical frailty and undernutrition in older adults undergoing elective abdominopelvic surgery in a general hospital in lima-perú. methods: this is a secondary database study from the original "physical frailty and adverse events in older adults undergoing elective pelvic abdominal surgery in a general hospital, lima-perú", it was realized between august and march , using validated face to face questionnaires. physical frailty was determined with fried criteria, undernutrition by mini nutritional assesment (mna). in adition, they also evaluated functional status and cognition. univariate models were performed, and logistic regression was done subsequently. results: older adult met inclusion´s criteria, the mean age was . (+ . ) years old, , % ( ) were female, , % ( ) had hypertension, , % ( ) were diabetic, the mean number of comorbidities were . (+ . ), , % ( ) had functional impairment, , %( ) had cognitive impairment. the mean bmi was . ± . . , % ( ) were underweight, . %( ) normal , . %( ) overweigth and . % ( ) obese. by mna % ( ) had risk or undernutrition, . % ( ) of them had functional impairment in contrast with , %( ) who weren´t at risk or undernutrition; p= . . also, . %( ) who had risk or undernutrition had cognitive impairment in contrast with . %( ) who weren´t at risk or undernutrition; p= . . by fried criteria, % ( ) were frailty, % ( ) prefrailty and , % ( ) robust. the frailty patients % ( ) had risk or undernutrition vs , %( ) in prefrailty and . %( ) in robusts; p= . . conclusion: there is an increased risk of undernutrition in frail older adults undergoing abdominopelvic surgery at a general hospital in lima, peru. background: cognitive frailty increases the risk of dementia, dependency and mortality in older people. moderatevigorous physical activity (mvpa) improves frailty syndrome and cognitive functions in older people, but being physically inactive is still prevalent. walking is the most common and inexpensive form of physical activity in older people and brisk walking is a form of mvpa. m-health has been successful in changing health behaviours in many populations. however, its effect in treating cognitive frailty through promoting mvpa in older people is not known. objectives: the aims of this study were to examine the effects and feasibility of an m-health intervention. methods: a pilot randomized controlled trial was employed. eligibility criteria include ) age > years, ) living in community, ) having cognitive frailty, and ) mobility at "outdoor walker" level. the study was conducted in community settings. subjects were recruited in the elderly community centres. subjects were randomized into either intervention or control at a : ratio. in the intervention groups, the subject received a smartphone pre-installed with physical activity tracking and social media applications. they received a course of brisk-walking in daily living training, health education, and a -week behavioural change intervention on the smartphone platform. in the control group, participants received a course of brisk-walking in daily living training, health education, and telephone follow-up. the outcomes were frailty (ffi), cognitive function (moca) and mvpa (actigraph). we targeted at recruiting totally subjects. nonparametric tests were used to compare the effects within and between groups. missing values were replaced by last observed values. results: this study recruited subjects (intervention: n= , control: n= ). significant improvements in frailty (p< . ), cognitive function (p< . ), and mvpa (p< . ) were observed in the intervention group after the completion of the intervention. only cognitive function was also observed to be improved in the control group (p< . ). the compliance of wearing devices (i.e., smartphones and actigraphs) and the usage of the smartphone applications were highly satisfactory. three subjects withdrew from the study (intervention: n= , control: n= ). conclusion: m-health intervention is feasible to treat cognitive frailty in older people. it is more effective to ameliorate frailty and increase mvpa in older people with cognitive frailty when compared to conventional training. background: the prevalence of dementia and associated healthcare cost increases with aging population. population health management and proactive screening with increased emphasis on primary risk reduction may reduce the overall prevalence of dementia. motoric cognitive risk syndrome (mcr) has been increasingly studied as a pre-dementia stage to identify older adults at risk of transiting to dementia while few studies explored the association between mcr and functional capabilities. objectives: the aims are to investigate the prevalence of mcr and its associated factors among community-dwelling older adult and also to examine possible impact of mcr on functional capabilities. methods: data for older adults aged above years old staying in northwest region of singapore was used. mcr was defined as slow gait speed over m ( sd below population mean) with subjective memory complaints in the absence of dementia. functional capability was determined by administering the lawton instrumental activities of daily living (iadls). differences in demographics, socioeconomic and lifestyle factors between mcr positive and mcr negative groups were found using independent t-test and chi-square test. risk factors of mcr and impact of mcr on functional capability were examined using logistic regression. results: the prevalence of mcr in the studied population was . %. after adjusting for demographics and socio-economic factors, indians (adjusted or = . , % ci = . - . , p = . ), increasing age (adjusted or = . , % ci = . - . , p < . ), higher bmi (adjusted or = . , % ci = . - . , p < . ) increased likelihood of mcr while increased years of education decreased likelihood (adjusted or = . , % ci = . - . , p = . ). the odds of having at least one impairment in iadl after adjusting for demographics, socio-economic and health factors amongst those with mcr were . (adjusted or = . , % ci = . - . , p = . ). conclusion: our study found in to have mcr, the pre-dementia stage. indian ethnicity, those with increased age and higher bmi are at greater risk of having mcr. as mcr is also associated with functional impairment, it can serve as a useful screening tool to identify those at risk of progressing to dementia. background: sleep disturbance has been found in older persons with dementia, which impact on the quality of life of older persons and on the caregiving burden of the family. little is known about the sleep patterns and sleep problems of older persons with dementia. exploring these data would provide basic information to develop interventions for this population. objectives: to explore sleep patterns and sleep problems in community-dwelling older persons with dementia. methods: the sample recruited by purposive sampling consisted of community-dwelling older persons with any stage of dementia who used healthcare services at outpatient departments of a university hospital, thailand. data were collected using a demographic data questionnaire, a sleep diary recorded by caregivers, and an electronic wrist activity tracker to assess sleep data for consecutive nights. the data had been collected for three months and were analyzed using descriptive statistics. results: the sample had an age range from to years (m= . , sd = . ). the total sleep data of the older persons with dementia consisted of episodes. almost all of the sleep data showed the polyphasic sleep pattern (sleeps for several periods of time a day), but a few had monophasic and biphasic sleep patterns. the total sleep time per night ranged from to hours with a mean of hours. the mean sleep latency was minutes, by which two-thirds of them had sleep latency less than minutes. three-quarters of the data woke up at night. the mean duration of waking up at night was minutes. two-thirds of the data had sleep problems, including insomnia, waking after sleep onset, and excessive daytime sleeping. also, most of them had snoring ( %), followed by sleep talking ( %). conclusion: the polyphasic sleep pattern was found mostly in older persons with dementia. also, they had sleep problems of insomnia at night and excessive sleeping during the daytime. healthcare providers may use the results from this study to understand the sleep patterns and then find strategies to promote the sleep quality of older persons with dementia. yumi umeda-kameyama , masashi kameyama , taro kojima , masaki ishii , shinya ishii , mitsutaka yakabe , kiwami kidana , tomohiko urano , , sumito ogawa , masahiro akishita (( ) department of geriatric medicine, the university of tokyo school of medicine, tokyo, japan; ( ) department of diagnostic radiology, tokyo metropolitan geriatric hospital and institute of gerontology, tokyo, japan; ( ) department of geriatric medicine, international university of health and welfare, narita, chiba, japan) background: «perceived age» of facial appearance in elderlies was shown to be a robust biomarker of aging that predicts survival, telomere length, and dna methylation. it is also reported to correlate with carotid atherosclerosis and bone status. objectives: this study aims to determine whether perceived age is a better biomarker than chronological age for a variety of aspects in dementia assessment, which includes general cognition, vitality, depressive state, and selfsupportability. methods: one hundred twenty-six patients admitted to the department of geriatric medicine, the university of tokyo hospital with suspect of cognitive decline were enrolled. mmse, vitality index, gds , iadl, and barthel index were performed. ten geriatricians and clinical psychologists determined the perceived age of subjects based on their photographs. results: the average values of rates showed excellent reliability (icc( , )= . ). perceived age showed significantly better correlation with mmse (female), vitality index (total, female), and iadl (total) than chronological age by steiger's test, but not with gds and barthel index. conclusion: perceived age was demonstrated to be a better biomarker for cognitive assessment than chronological age. l a u r a t a y , h u d a m u k h l i s , jolene ho , aisyah latib , eeling tay , shimin mah , candy chan , yeesien ng (( ) department of general medicine, sengkang general hospital, singapore; ( ) office of regional health system, singhealth, singapore; ( ) department of physiotherapy, sengkang general hospital, singapore; ( ) dietetics, sengkang general hospital, singapore) background: cognitive frailty is characterized by co-existence of physical frailty and cognitive impairment. earlier studies reported aggravated health outcomes attributable to cognitive frailty over physical frailty alone. objectives: we examine risk factors for cognitive frailty, and its impact on physical performance and health outcomes, compared with isolated occurrence of cognitive impairment or physical frailty. methods: cross-sectional analysis of communitydwelling older adults who completed multi-domain geriatric screen assessing for social vulnerability, mood, cognition, functional performance, nutrition, physical frailty (frail) and sarcopenia (sarc-f). cognitive impairment was defined using locally validated education-adjusted cut-offs on modified-chinese mini-mental state examination. participants underwent physical fitness tests comprising grip strength, gait speed, lower limb strength and power, flexibility, balance, and endurance. health outcomes included hospitalization, emergency department visits, falls and self-rating of health. each participant was categorized as robust-cognitive intact (pf--/ ci-), pre-frail/ frail only (pf+/ ci-), cognitive impaired only (pf-/ ci+), and cognitive frailty (pf+/ ci+). results: mean age of study cohort was . ( . )years. ( . %) were pf-/ci-, ( . %) pf+/ci-, ( . %) pf-/ci+, and ( . %) pf+/ ci+. in multi-nomial logistic regression referenced to pf-/ci-, older age significantly increased risk for pf-/ci+ and pf+/ci+. cognitive frailty contributes to worse physical performance and poorer health outcomes compared to physical frailty and cognitive impairment in isolation. while social vulnerability and depression were differentially associated with isolated frailty status, malnutrition and sarcopenia should be targets for preventing frailty and cognitive impairment. osamu katayama, sangyoon lee, seongryu bae, keitaro makino, ippei chiba, kenji harada, yohei shinkai, hiroyuki shimada (department of preventive gerontology, center for gerontology and social science, national center for geriatrics and gerontology, japan) background: cognitive frailty is a condition recently defined by operationalized criteria describing coexisting physical frailty and mild cognitive impairment (mci). however, there is no consensus on the definition of cognitive frailty for use in clinical and community settings. objectives: this study aimed to use latent class analysis (lca) to discover potential subtypes of cognitive frail older people. in addition, we explored the relationship between the identified cognitive frailty subtypes, and their demographical, neuropsychological, body composition, and lifestyle activity characteristics. methods: a total of community-dwelling older adults aged >= years participated in the study. we characterized physical frailty as >= of the following criteria: slow walking speed, muscle weakness, exhaustion, low physical activity, and weight loss. we used tests of word list memory, attention, and executive function, and processing speed to screen for cognitive impairment. the presence of >= cognitive impairments were defined as mci. we defined the condition where physical frailty and mci coexist as cognitive frailty. lca was applied to characterize classes or subgroups with different cognitive frailty phenotypes. subsequently, we performed multinomial logistic regression analysis with cluster membership as dependent variable and dichotomized demographics and lifestyle activity characteristics as independent variables. results: lca identified eight distinct subgroups included three different cognitive frailty phenotypes: cognitive frailty composed of physical frailty and amnestic mci (acf), cognitive frailty composed of physical frailty and non-amnestic mci (nacf) and, cognitive frailty in which physical frailty and global cognitive impairment (gcf). cognitive frailty subtypes were associated with distinct demographical, neuropsychological, and lifestyle activity characteristics. in particular, the acf cluster was associated with younger age and also related to the inactivity of productive and cognitive activities (p< . ). the nacf cluster was related to the inactivity of social and cognitive activities (p< . ). finally, the gcf cluster was associated with older age (p< . ). conclusion: using lca, we identified eight distinct subgroups included three different cognitive frailty phenotypes in a large sample of community-dwelling older adults. cognitive frailty subtypes were associated with distinct demographical, neuropsychological, and lifestyle activity characteristics. sara g aguilar navarro, alberto j mimenza alvarado, itzel aparicio gonzález, clarita cabrera juárez, alejandra samudio cruz, monsal alexa, ja avila funes, teresa juarez-cedillo (instituto nacional de ciencias médicas y nutrición salvador zubiran, ciudad de méxico, mexico) background: the prevalence of mild cognitive impairment (mci) ranges between - % and is times more frequent than dementia. the dcl has been associated with cardiovascular risk factors, mainly changes at the executive level. the apoe genotype, on the other hand, is a gene that confers susceptibility to alzheimer's disease in addition to participating in lipid metabolism, giving greater risk of atherosclerosis and cardiovascular risk. however, given the genetic heterogeneity of the mexican population, this association is not clear. objectives: to establish the strength of association between the different types of dcl (amnesic and non-amnesic) in mexican mestizo older adults according to their carrier status of the apoe allele and cardiovascular risk factors. methods: patients in a memory clinic were evaluated from to , older than years, without sensory deficit, psychiatric diseases or uncontrolled metabolic pathology, separating them into mutually exclusive groups: healthy controls, group with amnesic mci, group with nonamnesic mci, performing geriatric and neuropsychological evaluation. parametric and nonparametric statistics (x , anova, multivariate linear regression analyzes) were used to find statistical differences between groups. results: multivariate linear regression analyzes were performed to examine the relationship between vascular risk factors, the presence of the apoe ε allele, and cognitive change. apoe genotype significantly modified the associations between both hypertension and cardiovascular disease and a decline in language abilities as well as diabetes and decline in verbal memory, attention, and visuospatial abilities in non-amnestic mci. associations between increased vascular risk burden and greater cognitive decline were observed among apoe ε carriers but not non-carriers with mci. conclusion: the present study revealed an increase in the association between non-amnestic mci (apoe ε carriers with vascular risk factors) and suggests that the treatment of vascular risk factors could contribute to reducing the risk of progression of cognitive impairment, particularly among patients with apoe ε mexicans. background: a number of cross-sectional and longitudinal studies have demonstrated an association between physical frailty and cognitive impairment ( ). many mechanisms have been suggested to explain the presence of cognitive impairment in frail subjects, such as cardiovascular risk, hormonal disturbances, chronic inflammation or nutrition ( , ). another hypothesis is that cognitive impairment in frail patient may be due to alzheimer's disease (ad) ( , , ). however, the link between frailty and amyloid deposition has to date never been studied in vivo. objectives: ( ) to examine the prevalence of cerebral amyloid pathology as measured with amyloid positron emission tomography (pet) or amyloid-β- - level in cerebrospinal fluid, among frail and pre-frail individuals presenting an objective cognitive impairment ( ) to characterize the cognitive and clinical progression of frail cognitively impaired patients according to the amyloid status. methods: cogfrail is a monocentric observational prospective study of cognitive frail and prefrail older participants (according to fried criteria), aged >= years, with an objective cognitive decline (defined by a clinical dementia rating (cdr) scale scoreat . or ). the participants will be followed up every months, during years. in addition to cerebral amyloid pathology (measured by amyloid positron emission tomography (pet) or amyloid-β- - level in cerebrospinal fluid), measurements include cognitive performance, physical function, nutritional status, depressive symptoms biology, nutrition, magnetic resonance imaging (mri), and body composition to better understand the mechanisms and progression of cognitive frailty. results: the study is currently being recruited. to date, patients were included. mri pet scan and lumbar puncture have been performed. subjects completed the study. conclusion: this study will allow us to determine, for the first time, the prevalence of amyloid pathology, a marker of ad, among frail and pre-frail patients presenting objective memory impairment. the results will help characterize the cognitive decline in frail and pre-frail patients, with important implications for the detection, management and ultimately prevention of neurocognitive disorders among frail old individuals references: ) kojima g, taniguchi background: cognitive impairment is a well-known risk factor for falls in older adults. the risk of falls is increased in those with diminished executive function and reduced processing speed. while participants with cognitive deficits are more prone to falling, it is unknown whether risk of falling on cognitively intact individuals placing them at higher risk for future cognitive decline. objectives: to ascertain the incident development of cognitive decline in those at higher risk for falls using the center for disease control's fall risk assessment tool, steadi (stop elderly accidents, deaths, and injuries) in community dwelling individuals > years of age. methods: we identified individuals >= years old using the longitudinal national health and aging trends study (nhats) that consists of eight years of follow-up. these individuals did not have cognitive impairment at baseline. fall risk was defined using the algorithm from the center for disease control's steadi initiative. participants were classified at baseline in three categories of fall risk (low, moderate, severe). impaired global cognition was defined as nhats-defined impairment in either the alzheimer's disease- score, immediate/delayed recall, orientation, clock-drawing test, or date/person recall. the primary outcome was the risk of incident cognitive impairment over time. cox-proportional hazard models and linear mixed-effects modeling ascertained the incidence of cognitive impairment, adjusting for age, sex, smoking status, education, co-morbidities and an ability to walk. our referent variable was individuals at low steadi fall risk. results: of the , participants ( . % female), median age category was - years. prevalence of baseline fall risk using the steadi measure in participants was low ( . %), medium ( . %) and high ( . %). the rate of cognitive impairment in our sample was . %. in our fully adjusted model, the risk of developing cognitive impairment was hr . [ %ci: . - . ] in the intermediate risk group, and hr . [ %ci: . - . ] in the high risk group. using linear mixed-effects modeling yielded similar results. conclusion: steadi fall risk at baseline was predictive of higher rates of cognitive decline in those with normal cognition. elevated fall risk by steadi may suggest need for more thorough cognitive assessment. background: the concept of cognitive reserve (cr) has been developed as a potential factor able to describe individual differences in vulnerability to cognitive, functional, or clinical decline along aging. the progressive reduction of cognitive and functional performances represents an outcome commonly associated with aging. objectives: the aim of this crosssectional study is to investigate the association of cr with cognitive and functional outcomes in a sample of elderly outpatients. methods: subjects aged >= were consecutively recruited. patients who were unable to undergo the execution of required tasks due to severe cognitive, functional or sensory impairment were excluded. mini mental examination (mmse), brief intelligence test (tib) and cognitive reserve index questionnaire (criq) were administered. handgrip strenght, gait speed and daily life autonomy were measured; a frailty index (fi) was eventually calculated. results: data from patients were analyzed. criq was significantly correlated with mmse (r = . , p < . ), handgrip (r = . , p < . ) and gait speed (r = . , p= , ). furthermore, criq was correlated with badl (r = , , p= , ), iadl (r= , , p= , ) and inversely with fi (r= - . , p < . ). significant correlations were found between tib and mmse (r = . , p < . ), between tib and criq (r = . , p < . ), and between tib and iadl (r = , , p= , ). conclusion: this preliminary report highlighted that patients with higher cr showed not only better overall cognitive functioning, but also better functional status and a lower degree of frailty. in the light of a multidimensional geriatric assessment, the integrative evaluation of cr in elderly might offer the opportunity to track possible trajectories of aging, since it appeared related either to cognitive status, either to functional oucomes and to frailty. background: the clinical syndrome of "physical" frailty has been conceived without regard for cognitive decline. nevertheless, it has been suggested that frail elders exhibit frailty-specific cognitive impairments, and that the cognitive correlates of frailty may be dementing in their own right. meanwhile, we have used confirmatory factor analysis (cfa) in a structural equation model (sem) framework to construct a latent dementia phenotype, "δ". our approach is modular and can be redirected to other clinical targets. objectives: in this analysis, we create a δ ortholog representing the "cognitive correlates of frailty" (df). methods: first, we constructed a frailty index (if) from wave- data collected as part of the hispanic established population for epidemiological studies in the elderly (h-epese). a δ ortholog targeting if was then constructed from a cognitive battery that included the mini-mental status exam (mmse) and clox: an executive clockdrawing task (clox). results: the model fit the data well and df exhibited factor determinance. dfrailty was strongly indicated (r = . , p< . ) by if and explained % of the index's variance. it was also significantly indicated by mmse and clox scores. df was strongly correlated (r = . , p< . ) with instrumental activities of daily living (iadl), independently of age, gender and education. the remaining % of if's variance had no significant association with iadl. the orthogonal latent variable "g'", df's residual in spearman's general intelligence factor "g", was strongly indicated by all three cognitive performance measures. nevertheless, it was weakly associated with iadl. measure specific cognitive performance, residual to both df and g', had no independent: association with iadl. conclusion: these results suggest that the frailty syndrome does indeed have specific cognitive correlates. these are strongly associated with iadl and therefore potentially "dementing". like δ, the cognitive correlates of frailty are extractable from spearman's g, which may constrain the biology and psychometric properties of frailty-specific cognitive changes. independently of df, cognition has little association with iadl. this suggests that frailty may be a major determinant of iadl performance in elderly ma, and possibly a major etiology of "all cause" dementia in that population. background: cognitive-frailty has been proposed as a distinctive entity which preludes dementia. objectives: we aimed to examine the relationship between physical frailty, cognitive status, and gait performance as predictors of cognitive decline and incident dementia. methods: cohort study of community older adults free of dementia at baseline with a year follow-up. inclusion criteria: > years, english speaking, able to ambulate one city block. exclusion criteria: hip/knee joint arthroplasty in past months, parkinsonism, major depression, and diagnosis of dementia (dsm-iv criteria). cognition was assessed using the moca, the mmse, and the clinical dementia rating (cdr) scale was performed. physical frailty was defined using the phenotypic criteria described by fried and walston. cognitive-frailty was defined as the simultaneous presence of physical frailty with objective cognitive impairment, and absence of concurrent dementia. the main outcome measure was all-cause dementia (dsm-iv criteria). cox proportional hazards models were used to estimate the risk of cognitive decline and incident dementia. results: over a -year follow-up, participants experienced cognitive decline and participants progressed to dementia (global incidence rate (ir): per -person/y). participants with frailty had a higher prevalence of cognitive impairment ( %) compared to those without ( %, p= . ) but the risk of progression to dementia was not significant. adding cognitive impairment to the frailty phenotype (cognitive-frailty) predicted further cognitive impairment and progression to dementia. dementia ir for frailty was per person/y and for cognitive-frailty, per person/y. however, when slow gait was combined with baseline cognitive impairment, it showed the highest risk of progression to dementia (hr: . , %ci: . - . ; p = . ) with an ir of per person/y. conclusion: frailty and cognitive impairment are common and often coexist in the same individuals. however, slowing gait seems to be the frailty component driving the association with future dementia. background: assisted bathing requires the most hours of home care. for the frail elderly and their caretakers, the bathroom presents the most risk factors for falls and injury. bathroom adaptation is the primary reason for consultation in community occupational therapy and available resources cannot meet the increasing demand. the hygiene . (h . ) website (https://algo.grismoir.com/) addresses this need by offering a structured questioning to identify bathing assistive technology for the frail elderly living at home. objectives: our actionresearch protocol aims to establish a partnership between actors in the home care social economy enterprises (eÉsad), the home care programs offered through the healthcare system and the private sector (e.g., assistive technology providers). this implies: ) adapting h . to the home care service workers' needs; ) designing an implementation model for h . in order to formalize a partnership in the community; ) conducting pilot testing in two eÉsad. methods: ) user-centered design and a multiple case study where a case represents a home care worker (n= ) from a eÉsad (québec, canada) offering bathing assistance for the elderly. during testing, the home care worker will explore the h . prototype with an elderly in his or her home, sharing their thoughts out loud. the unit of analysis is the usability of h . , allowing improving to the prototype after every three participants. ) all collaborators will participate in the iterative modification of a preliminary logic model for the implementation of h . . modifications suggested will be integrated to the model throughout three meetings, or until a consensus is reached. ) the adapted version of h . (obj. ) will be tested according to the implementation model developed (obj. ). a pilot project using mixed methods in collaboration with two eÉsad will be conducted with older adults having difficulty bathing. results: anticipated results: responsive h . website adapted to the users' needs, an implementation model and pilot data allowing scaling-up technology meeting needs of frail elderly and their caretakers issues during bathing. li-ning peng , , , fei-yuan hsiao , , , wei-ju lee , , , shih-tsung huang , liang-kung chen , , ( ( ) background: the theory of cumulative deficits using big data to develop the multimorbidity frailty index (mfi) has become a widely accepted approach in public health and healthcare services. however, constructing the mfi using the most critical determinants and stratifying different risk groups with dose-response relationships remain major challenges in clinical practice. objectives: this study aimed to develop the mfi by using machine-learning methods that select variables based on the optimal fitness of the model and to further establish four entities of risk using a machine-learning approach as well as to ensure the dose-response relationship and the best distinction between groups. methods: in this study, we used taiwan's national health insurance research database to develop a machine-learning multimorbidity frailty index (ml-mfi) using the theory of cumulative diseases/deficits of an individual older person. compared to the conventional mfi, in which the selection of diseases/deficits is based on expert opinion, we adopted the random forest method to select the most influential diseases/deficits that predict adverse outcomes for older people. to ensure that the survival curves showed a dose-response relationship with overlap during the follow-up, we developed the distance index and coverage index at any time point to classify the ml-mfi of all subjects into the categories of fit, mild frailty, moderate frailty and severe frailty. survival analysis was conducted to evaluate the ability of the ml-mfi to predict adverse outcomes, such as unplanned hospitalizations, intensive care unit (icu) admissions and mortality. results: the final ml-mfi model contained diseases/deficits in this study. compared with conventional mfi, both indices had similar distribution patterns by age and sex; however, among people aged - , the mean mfi and ml-mfi were . (standard deviation (sd) . ) and . (sd . ), respectively. the difference may result from discrepancies in the diseases/deficits selected in the mfi and the ml-mfi. a total of , subjects aged to years were included in this study and were categorized into groups according to the level of the ml-mfi. both the kaplan-meier survival curves and cox models showed that the ml-mfi significantly predicted all outcomes of interest, including all-cause mortality, unplanned hospitalizations and all-cause icu admissions, at , and years of follow-up (p< . ). in particular, a doseresponse relationship was revealed between the four ml-mfi groups and adverse outcomes. conclusion: the ml-mfi consists of diseases/deficits that can successfully stratify risk groups associated with all-cause mortality, unplanned hospitalizations and all-cause icu admissions in older people, which indicates that precise, patient-centered medical care can be a reality in an aging society. to return home. understanding the home environment prior to discharge is crucial. occupational therapists (ots) often depend on client's verbal descriptions, pictures and sketches when planning rehabilitation exercises and suggesting adaptations. the information obtained is therefore partial. mapit is a new mobile application which scans a room producing a d representation with virtual measurements of environmental elements. this could provide a more complete representation of the home needed by inpatient rehabilitation ots. objectives: to target mapit's clinical applications for inpatient rehabilitation of the frail elderly. methods: multiple case study where mapit was introduced in three inpatient geriatric rehabilitation units over days. five ots maintained a logbook and participated in four individual semi-structured interviews. a deductive thematic analysis of the logbooks and interview transcripts was corroborated by two additional ots. results: mapit is useful for ots in rehabilitation settings by allowing them to ) see it: see the home environment, ) measure it: take measurements of desired environmental elements, ) document it: have a copy of the environment on hand, ) communicate it : facilitate exchanges with the client and with colleagues. with mapit, ots gain a better understanding of the environment, which informs the rehabilitation intervention. better communication could also improve the client's implementation of the therapeutic strategies. conclusion: mapit is a useful resource to optimise intensive rehabilitation for the frail elderly. sonia jiménez-mola , javier idoate-gil , david idoate , maría plaza carmona (( ) geriatric department, complejo asistencial universitario, león, spain; ( ) university of salamanca, salamanca, spain; ( ) urgency department, complejo asistencial universitario, león, spain) background: as the age of the population increases, the incidence of osteoporosis and its direct consequence, fragility fractures, are also increasing. hip fractures are associated with the greatest number of complications, functional deterioration, and mortality of up to % one year after the fracture. objectives: the aim of this study is to determine the prevalence of previous diagnosis of osteoporosis in elderly patients who suffer hip fracture and its relationship with age distribution ( - , - and > years old), gender, type of fracture and funtionality. methods: we enrolled patients with hip fracture, aged years or older in an orthogeriatric unit between december and november . underwent comprehensive geriatric assessment that evaluates comorbidities, medication use, ability to perform basic activities of daily living, place of residence, anesthesia risk as measured by the asa score, type of fracture, type of surgery and anesthesia and in-hospital mortality. spss®, v. . . results: the mean age was . ± . years ( - years). . % female. % pertrochanteric fractures. ( %) underwent surgery. only . % received general anesthesia. % walked independently, % had barthel > , ( %) had a previous diagnosis of dementia, and % live in nursing home prior to fracture. we found a previous diagnosis of osteoporosis in patients ( . %). in these patients, statistically significant differences were shown for sex p< . ( . % female vs . % male), age distribution p< . ( . %( - ) vs . % ( - ) vs . % (> ) and the presence of anti-osteoporotic treatments p< . . all other measurements (barthel index, cognitive degree, type of fracture, asa score and type of surgery, did not show statistically significant differences (p>. ). conclusion: patients in very advanced age showed neither significantly higher percentage of diagnosed osteoporosis, not significantly higher amount of preexisting osteoporosis-related medication. although the prevalence of osteoporosis increases with age, the diagnosis and treatment prevalence decreased in higher age groups. background: aging is associated with a decrease in bone density, muscle mass and a gain in fat mass which increase physical disabilities and falls. nevertheless, the impact of obesity on bone density and architecture is still controversial. furthermore, protein intake appears to be associated with maintenance of muscle and physical function, but also with bone density and architecture. however, the role of initial protein intake in osteopenic-obese older adults is still unclear. objectives: to examine the influence of initial protein intake on muscle and bone function in osteopenic-obese older adults. methods: cross-sectional a-posteriori matched study design. fourteen obese (total fat (%): men > ; women: > ) osteopenic (bmd t-score <- . ) older adults (age > years old) were divided in groups according to their initial protein intake (prot-(n= ): < g/kgbw/d or prot+ (n= ): > . g/ kgbw/d) and were matched for age (± years) and gender. body composition (fat, fat-free and bone masses, dxa), muscle composition and bone architecture (qpct), muscle function (grip strength, knee extension strength, muscle power), physical performance (walking speed ( m), tug ( m), unipodal balance, stair and chair tests), cardiorespiratory function ( min walking test) and lifestyle habits (physical activity level: -axial accelerometer and nutritional status: food record) were assessed. results: our groups (prot-vs. prot+) were similar (p> . ) in terms of age ( . ± . vs. . ± . years), bmi ( . ± . vs. . ± . kg/m ), body fat (total(%): . ± . vs. . ± . ), muscle quantity (fat-free mass or limb muscle area) and quality (intra & submuscular adipose tissues), bone density (total hip or spine) and architecture (marrow, cortical or total area, and compressive or torsion strength), physical performance (walking speed(m/s): . ± . vs. . ± . ), cardiorespiratory function, lifestyle habits (steps: ± vs. ± ), except (by design) for the initial amount of protein intake ( . ± . vs. . ± . g/kgbw/d) respectively. conclusion: the initial protein intake does not seem to influence bone architecture, muscle function, or physical performance in elderly osteopenicobese. obesity but also the level of protein intake above the official recommendation (> . g/kgbw/d) could explain these conclusions. thus, future studies are needed to confirm our preliminary results. background: the glim definition of malnutrition is the first intended to be used globally. glim uses five criteria (two phenotypic and three etiologic) for the diagnosis of malnutrition, which is made when at least one etiologic and one phenotypic criterion are present. mna-sf is a validated widespread screening tool used in geriatric settings. glim and mna have not been compared in acute geriatric care. objectives: to measure the prevalence of malnutrition in older patients admitted to an acute geriatric unit using glim criteria and to assess the accuracy of the mna-sf in predicting glim defined malnutrition. methods: a prospective study was conducted among all patients older than years old admitted to an acute geriatric unit. end-of-life situations and wearers of pacemakers were excluded. glim criteria and mna-sf were assessed on admission. muscle mass (one of the glim criteria) was estimated by bioimpedance (thresholds for low muscle mass: < . kg in men; < . kg in women). results: patients were included (mean age . ± . years, % women). on admission, . % were malnourished according to the glim criteria ( . % met at least one etiologic criterion, . % met at least one phenotypic criterion). . % were malnourished using mna-sf. however, there was no correlation between glim and mna-sf (correlation coefficient r=- . , p= . ). mna-sf had low sensitivity ( . %) and low specificity ( . %) to detect malnutrition diagnosed with the glim criteria (roc curve auc= . ). conclusion: more than half of the very old patients admitted to an acute geriatric unit were malnourished according to the glim diagnostic criteria. a very similar proportion of patients had a mna-sf suggesting malnutrition. however, mna-sf had a low reliability to detect patients with glim defined malnutrition. corina naughton , rachel simon , tj white , darren daly ( ( ) background: hospitalised older adults are at risk of hospital associated decline (had). optimising nutrition intake is an important modifiable factor in protecting against had and promoting recovery, but food intake and the quality of mealtimes are frequently overlooked nursing activities. objectives: the study aim was to undertake an in-depth analysis of mealtime practices and to identify patient and mealtime factors associated with low food intake (<eating % of meal provided). methods: we carried out structured observation of mealtimes using a validated tool examining patient positioning, mealtime set up and assistance. the primary outcome was food consumption categorised as , %, % % or % based on visual inspection of food trays. data were also collected on patient characteristics. data analysis used descriptive statistics and univariate logistic regression to examine the association between low food intake and mealtime and patient factors. results: we included mealtime observations on patients aged years and older. at % (n= ) of meals, patients ate half or less of the food provided. meal time factors with a weak association with low intake were: allocated red tray (an indicator of nutrition risk), modified diet, and needing assistance. breakfast time was the most important meal for food intake. nearly half of the patients ( / ) ate % or less of the food provided on two or more occasions over a -hour period. patient frailty and a moderate to high nutrition risk score were independently associated with low food intake. conclusion: patient factors are the strongest predictors of low food intake. increasing the quality of the mealtime experience and more tailored nutrition plans could improve nutrition intake in frail older adults. were hospitalized at least once, ( . %) fell at least once, and ( . %) had at least one fracture during the -year follow-up. no association was found between malnutrition and -year risk of institutionalization, hospitalization, falls, or fractures (p> . ). conclusion: malnutrition according to glim criteria was associated with a . -fold higher mortality risk; double that of the espen criteria, during a -year followup. no association was found between malnutrition according to these two criteria and incidence of other adverse health consequences. glim criteria anticipate outcome and might guide interventions, with important implications for clinical practice and research. background: older adults are at high risk of developing cardiovascular disease. pre-clinical studies indicate that resveratrol (rsv), a polyphenol present mostly in grapes and red wine, may prevent development of cardiovascular disease. objectives: our hypothesis was that rsv will reduce biomarkers of cardiovascular disease risk in obese, rather healthy older adults in a dose-dependent manner. methods: older participants ( years and older) were randomized to a day rsv treatment with mg (n= ), mg (n= ) or placebo (n= ). we measured levels of atherosclerosis development risk biomarkers i.e. oxidized low-density lipoprotein (oxldl), soluble e-selectin- (se-selectin), soluble intercellular adhesion molecule- (sicam- ), soluble vascular cell adhesion molecule- (svcam- ), total plasminogen activator inhibitor (tpai- ). statistical significance was set at p< . . results: changes in svcam- mg vs. mg vs. placebo: (- . ± . ng/ml vs. . ± . ng/ ml vs. . ± . ng/ml) and tpai- mg vs. mg vs. placebo (- . ± . ng/ml vs. . ± . ng/ml vs. . ± . ng/ ml) indicate significantly higher levels in a mg group compared to a mg and a placebo groups. other biomarkers ( mg vs. mg vs. placebo: oxldl, seselectin- and sicam- ) followed the same trend toward higher levels in the mg group compared to the mg and placebo groups, without reaching statistical significance. conclusion: this pilot project suggests that a higher dose of rsv may increase the levels of cardiovascular disease risk biomarkers in overweight older adults. given no change in the cardiovascular disease risk biomarkers in response to a lower dose, future studies should test the effects of different doses of rsv on reduction of cardiovascular disease biomarkers in overweight, rather healthy older adults. background: actual nutrition is a factor that continually effects physiological capacity and workability, the functional aging rate of an elderly persons. objectives: the purpose of this study was to determine the relationship between nutrition and physiological abilities, the work performance, functional aging rate, residual working capacity and frailty of the elderly. methods: it has been studied anthropometric and functional parameters of respiration, physical performance, mental capability, sensory skills, as well as the rate of functional aging in different aging groups: - years - persons, - years - persons, - years - persons. we have also analyzed the professional history, social status, and factual nutrition (according to the questionnaire proposed by the who and adapted for ukraine) of the elderly. results: the nutrition or diet factors influence on the problems dealing with working capability, reduction of the hand grip strength and endurance, independence and frailty (for elderly) in overall . % for all mentioned factors. right and left hand grip strength associate with protein consumption (r = . ; r = . ; p < . accordance) with variety of cereals (r =- . ; r =- . p < . accordance) also with variety of vegetables (r = . ; r = . ; p < . accordance)variety of fruits (r = . ; p < . ; r = . ; p < . accordance). it was studied features of an actual food at centenarians of ukraine which not only have lived to this old age, but also have the relatives who have lived to age of centenarians. it was established, that meals of ukrainian centenarians include high percentage of vegetables, fruits and dairy products. meanwhile menu has been deprived practically all basic alimentary pathology risk factors which accelerates biological age, creates certain preconditions to preservation of health and longevity. conclusion: as a result of a comprehensive study and mathematical modeling was developed a quantitative method for assessing the residual working capacity for elderly persons. background: age-related decline in olfactory function has implications for health and nutrition due to reduced appetite and decreased sensory perception of food. several studies have investigated olfactory performance in the elderly, but studied mostly single odour components often less related to food and meals. food odours are composed of multiple odorants and compensation for specific perceptual losses among elderly may occur. therefore, it is relevant to study olfactory perception of complex food odours to improve understanding of odour perception in the context of foods and meals. objectives: to develop a test method to screen young and elderly ( +) subjects on their olfactory capacity for everyday food odours. the method included a series of sniffing sticks with relevant and familiar complex food odours from primarily essential oils. methods: the olfactory sniffing sticks test kit was developed in four steps: ) selection and validation of relevant, familiar and diverse food odours, evaluated on perceived familiarity. ) standardization of an iso intensity reference level for the food odours in relation to n-butanol. ) assessment of shelf-life stability for the sniffing sticks within an weeks period. ) evaluation of test-retest reliability for intensity and identification of the odours within a weeks period. results: food odours were selected due to their diverse sensory characteristics. they were provided from a french manufacturer which may have compromised the familiarity in a danish context as only out obtained satisfactory familiarity score. however out showed reliable results in a test-retest procedure. n-butanol, in two concentrations provided a satisfactory reference frame for the iso intensity scaling. furthermore the food odours were overall shelf-life stable within an weeks period. conclusion: a new odour test kit for everyday food odours was developed and validated for screening olfactory capacity (intensity perception, familiarity and identification) in elderly subjects. based on the evaluations, odours were included in the final test kit. this olfactory test reflects the complex stimulation of the olfactory system, when stimulated by eating a food, compared to odour test kits with single or few components which makes it relevant when customizing of meals for elderly to improve nutrition and wellbeing. background: nordic nutrition recommendations (nnr) ( ) suggest protein intake >= . g/kg body weight (bw) to preserve physical function in nordic older adults. however, no published study has used this cut-off to evaluate the association between protein intake and frailty. objectives: this study examined associations between protein intake, and sources of protein intake, with frailty status at the -year follow-up. methods: participants were women aged - years enrolled in the kuopio osteoporosis risk factor and prevention -fracture prevention study. protein intake g/kg bw and g/d was calculated using a -day food record at baseline . at the -year follow-up ( ), frailty phenotype was defined as the presence of three or more, and prefrailty as the presence of one or two, of the fried criteria: low grip strength adjusted for body mass index, low walking speed, low physical activity, exhaustion was defined using a low life satisfaction score, and weight loss > % of bw. the association between protein intake, animal protein and plant protein, and frailty status was examined by multinomial regression analysis adjusting for demographics, chronic conditions, and total energy intake. results: at the -year follow-up women were frail and women were prefrail. higher protein intake >= . g/kg bw was associated with a lower likelihood of prefrailty (or= . and % confidence interval (ci) = . - . ) and frailty (or= . and ci= . - . ) when compared to protein intake < . g/kg bw at the -year follow-up. women in the higher. conclusion: protein intake >= . g/kg bw and higher intake of animal protein may be beneficial to prevent the onset of frailty in older women. background: sarcopenia is a geriatric syndrome with increasing importance due to the aging of the population. progressive resistance training and protein supplementation are currently recommended for the prevention and treatment of sarcopenia. however, elderly are less responsive to these anabolic stimuli compared to healthy adults. inflammation is considered an important contributor to this age-related anabolic insensitivity. therefore, anti-inflammatory strategies, such as omega- , are a promising strategy to combat sarcopenia. furthermore, omega- were also shown to improve muscle anabolism though activation of the mtor signalling pathway and reduction of insulin resistance. objectives: firstly, we performed a narrative review of literature that gives an overview of the current knowledge about omega- intake and sarcopenia defining parameters (grip strength, gait speed, muscle strength or physical performance). secondly, we provided an overview of data on omega- supplementation and sarcopenia defining parameters. methods: a literature search was conducted in november , using electronic bibliographic databases (pubmed and embase). the reference lists of all full texts retrieved during the search process or as identified in already published (systematic) reviews were scanned. results were published in a narrative review (dupont j. et al. aging clin exp res.) results: seven observational studies described the associations between omega- intake and sarcopenia defining parameters. four interventional studies looked at the effect of omega- supplementation alone and suggested an improved muscle protein synthesis, improved gait speed and increased muscle strength and physical performance. three studies combining exercise with omega- supplementation suggested an enhancing effect of the supplement on the exercise-induced gains in muscle mass and strength. we found one study combining omega- and protein supplementation with exercise, but omega- dosage was too low for conclusive results. conclusion: observational data on omega- intake and sarcopenia remain conflicting. from current interventional data we conclude that there is growing evidence for a beneficial effect of omega- supplementation in sarcopenic elderly, which may add to the effect of exercise and/or protein supplementation. however, the exact dosage, frequency and use (alone or combined with exercise and/or protein supplementation) in the treatment and prevention of sarcopenia still need further exploration. background: with the growing incidence of cancer in older persons, malnutrition rates have increased. tumor-related malnutrition is a risk factor of treatment side effects. it reduces the quality of life and increases morbidity and mortality. therefore, malnutrition screening and diagnosis are mandatory to implement proper nutritional support. objectives: this study aimed to evaluate and compare the short form of mini nutritional assessment (mna-sf) nutritional screening tool with the new global leadership initiative on malnutrition (glim) diagnostic criteria for malnutrition among elderly patients with cancer. methods: patients >= years old, with a g screening tool ≤ , were referred to an oncogeriatrics consultation between february and september . the data recorded comprehended, demographic variables (age, sex), type of tumor, functional (barthel, lawton index, fac) and mental (mmse, yesavage) status, nutritional (mna-sf, glim criteria) and social assessment and number of drugs. if-vig, cirs-g, rockwood-ms, cci-sf, sppb and handgrip strength were used to estimate frailty. the roc curve was used to evaluate the ability to accurately distinguish malnourished patients. to determine diagnostic concordance between the assessment and the new glim diagnostic criteria of malnutrition, retrospectively analyzed, cohen's К statistic was calculated. results: patients were included, mean age . ± . , . % were women. gastrointestinal ( . %) and gynecological ( . %) neoplasms were most prevalent. . % were independent or had mild dependence on badl, . % on iadl. . % had no cognitive impairment and . % had no depressive symptoms. frailty scales showed a pre-frail patient profile, with good social support and a . ± drugs on admission. according to the new glim diagnostic criteria for malnutrition, % of the patients were malnourished. with the use of mna-sf, . % of the patients were found to be at risk of malnutrition. the roc curve of mna-sf had an area under the curve (auc) of . . no concordance was found between the mna-sf and the malnutrition diagnostic results (К= , p< . ). conclusion: in this small sample, most cancer patients were male, > years old, with low frailty index, good functional and mental status and at risk of malnutrition. the mna-sf scale detected more risk cases so preconditioning and nutritional recommendations before specific oncological therapies could be made. concentration is associated with muscle mass and strength in healthy elderly. however, there are several confounders, including body composition, nutrient intake, physical activity level and blood parameters which may also influence muscle mass. previous studies have not thoroughly examined the relationship between serum (oh)d concentration and muscle indices by comprehensively considering the potential confounders in healthy elderly. objectives: the purpose of this study was to investigate the relationship of serum (oh) d concentration with muscle mass and strength in healthy japanese elderly. methods: this cross-sectional study included healthy elderly in shiga prefecture in japan (age: . ± . years, m = , w = ). total fat-free mass (tffm) and appendicular (affm) were measured using dual-energy x-ray absorptiometry. in addition, handgrip strength and leg extension power were measured. a blood sample was collected in an overnight fasted state, and serum (oh)d concentration was assessed. habitual dietary intake and physical activity were assessed. protein intake, carbohydrate, and vitamin d intakes were adjusted for energy by the residual method. association of serum (oh)d concentration with tffm, affm, handgrip strength, and leg extension power was assessed by hierarchical multiple regression analysis with adjustment for age, gender, weight, energy, energy-adjusted protein, carbohydrate, vitamin d intakes, serum albumin concentration, and physical activity. results: the mean serum (oh)d concentration of participants was . ± . nmol/l. low serum (oh)d status (< nmol/l) was observed in . % ( / ) of participants. the mean affm was . ± . kg, and handgrip strength was . ± . kg. serum (oh)d concentration was significantly associated with affm (β = . , p = . ), but not with tffm (β = . , p = . ), handgrip strength (β = . , p = . ) and leg extension power (β = - . , p = . ). conclusion: serum (oh)d concentration is related to affm japanese healthy elderly people, even if confounders are comprehensively considered. background: muscle quality, often defined as force produced per area or mass of muscle, declines as people age. objectives: we hypothesized that dietary protein quality will better predict muscle quality than energy, carbohydrate, protein, fat, or leucine intakes when controlling for age, bmi, composition, and moderate to vigorous physical activity (mvpa). methods: strength was measured using isokinetic dynamometry at degrees per second, leg composition (lc) was examined via dual-x-ray-absorptiometry, and mvpa was measured with accelerometry. dietary intake was estimated using three-day food logs and esha software. muscle quality was defined as right knee extensor peak torque relative to right leg lean mass. protein quality was the ratio of total leucine over total protein intake. multiple linear regression and stepwise linear regression models were used. results: ninety-four women (mean ± sd; age . ± . years; bmi . ± . kg/m ; lc . ± . % fat; mvpa . ± . min/day; energy , ± kcal/day; carbohydrate . ± . g/ day; protein . ± . g/day; fat . ± . g/day; leucine . ± . g/day) completed the assessments. only protein quality (mean ± sem; beta = . ± . ; t = . ; p = . ) was significant to the full regression model containing all covariates (r = . ; adjusted r = . ; f ( , ) = . ; p = . ). to verify the importance of protein quality, a stepwise regression analysis using the same variables was performed and resulted in a model (r = . ; adjusted r = . ; f ( , ) = . ; p < . ) that included protein quality (mean ± sem; beta = . ± . ; t = . ; p = . ) and energy intake (mean ± sem; beta = . ± . ; t = . ; p = . ). conclusion: dietary protein quality is positively associated with muscle quality when controlling for bmi, lc, mvpa, and energy, protein, fat, carbohydrate, and leucine intakes. the most parsimonious model included protein quality and energy intake, suggesting that they are most related to muscle quality. background: it has been suggested that disruption of the apoptotic process may have an effect on the incidence of sarcopenia. on the other hand, one of the dietary recommendations for seniors is to increase their daily protein intake. however, the effect of protein intake on apoptosis is not well understood. objectives: the purpose of this study was to investigate the effect of eight weeks of protein whey supplementation on the expression of genes involved in the internal and external pathways of apoptosis of long extensor muscle of thumb of aged wistar rats. methods: this is an experimental studies. statistical sample of this study consisted of male wistar rats (age: months, weight: ± gr). they were randomly divided into supplement (n= ) and control (n= ) group. supplement group received . gr per body weigh protein whey daily for eight weeks. the left thumb extensor muscle of all subjects was carefully separated and after freezing in liquid nitrogen transferred to - ° c. quantitative real time-pcr was performed to measure bax, bcl- , caspase , and gene expression levels. independent t-test and mann-whitney u test were used to compare the means and rankings. the hypotheses were tested at the significant level p< . . results: results showed that bax, caspase , caspase , and caspase genes expression increased in all samples in training group compared to the control group but this increase was only significant for bax, caspase and gens (p < . ) and also bcl- gene expression significantly deceresed (p < . ) in comparison with control group. conclusion: it seems that protein supplementation lead to activation of the internal pathway of apoptosis by increasing mitochondria permeability. background: the presence of obesity alongside with impaired aging in general, and with impaired muscular performance in particular, may result in a unique and growing phenotype of obese frail/sarcopenic, which may be hardly diagnosed by simple observation. characterizing the nutritional intake of this phenotype is of a substantial relevance. objectives: to characterize the nutritional intake among frail prone (fp) and obese subjects in a sample of community dwelling older adults in israel. methods: in this cross sectional study we evaluate the nutritional intake of frail, frail prone and robust subjects (with and without the presence of obesity), as well as their adherence to the dietary reference intakes (dri). data were retrieved a series of national studies on the status of health and nutrition in different age groups in israel (mabat zahav) for [ ] [ ] . the frailty likelihood presented here is based on a previous study from our group suggesting a non-direct validated model estimating frailty based on components. results: compared to the robust, fp subjects were more likely to have lower intake of several nutrients. among them are: iron (mg) (mean . vs. . , p < . ), vitamin c (mg) (mean . vs. . , p < . ), folate (μg) (mean . vs. . , p < . ), vitamin a (iu) (mean . vs. . , p = . ). the average overall adherence score according to the dri (based on a sum of nutritional components) was . among fp subjects, compared to . among robust subjects (p = . ). obesity either defined by bmi or by wc had a lower «effect» on the nutritional intake differences as compared to frailty status. this observation was seen when obese subject were compared to non-obese subjects and as fp subjects were more likely to show a poor nutritional status regardless of the presence of obesity. conclusion: our results show a clear association between frailty and poor nutritional intake, regardless of the presence of obesity. moreover, the functional status may better reflect nutritional gaps than obesity -challenging the concept of the frail -obese phenotype regarding to nutritional status. background: the loss of bone density during aging induces risks of falls, fractures and mobility decline. moreover, bone structure seems to be a better predictor of fractures than bone density. these phenomena are exacerbated in the presence of sarcopenia. however, dynapenia alone or in combination with obesity is more involved in falls and loss of mobility than sarcopenia. nevertheless, the impact of obesity on bone density and bone structure is still controversial. furthermore, protein intake appears to be associated with maintenance of muscle, bone density and bone structure. to our knowledges, the impact of protein intake on bone density and bone structure among dynapenic-obese older adults is not known even if this condition reached around % of elderly. objectives: to assess the influence of protein intake on bone density and bone structure among dynapenic-obese older adults. methods: twenty-six older adults (>= years), obese (%fat: men > ; women: > ) and dynapenic (relative to body weight grip strength: men < . ; women < . ) were divided into groups according to their initial protein intake : prot-: < g/kg/d (n= ; . % of women; . ± . years) and prot+: > . g/ kg/d (n= ; . % of women; . ± , years). the following measurements were performed: relative to body weight grip strength using lafayette dynamometer, body composition using dxa, femoral bone structure using ct-scan, nutritional intake using the -day food record method. results: excepted, by design, for initial protein intake, both groups were comparable at baseline. the prot-group had a higher (p< . ) marrow area ( ± ) than the prot + group ( ± ). in addition, the compressive loading strength was greater (p< . ) in the prot-group ( ± ) than in the prot + group ( ± ). finally, the total bone area was larger (p< . ) in the prot-group ( ± ) compared to the prot + group ( ± ). conclusion: surprisingly, a lower protein intake but higher than rda seems to protect bone structure but not bone density among dynapenic-obese older people. these results should be confirmed in larger studies designed to address this question. background: unintentional weight loss occurs in % to % of older adults and has been associated with morbidity, functional incapacity, risk of hip fracture, and overall mortality. while the impact of this condition is well established in frailty, studies involving sarcopenia are still insipient. objectives: to investigate the association between unintentional weight loss and sarcopenia in community-dwelling older adults. methods: a cross-sectional study was conducted among older adults (>= years) assisted in primary care. the unintentional weight loss was assessed by questions contained in three frailty assessment tools and one nutrition screening and assessment tool, described below: ( ) "have you recently lost weight such that your clothing has become more loose?" [edmonton frail scale (efs)]; ( ) "have you lost a lot of weight recently without wishing to do so? ('a lot' is: kg or more during the last six months, or kg or more during the last month)" [tilburg frailty indicator (tfi)]; ( ) "in the last year, have you lost weight unintentionally (i.e., not due to dieting or exercise)? (unintentional weight loss is: more than . kg or of at least % of previous year's body weight)" [phenotype for frailty (pf)]; ( ) «weight loss greater than kg during the last months" [mini nutritional assessment (mna®)]. sarcopenia was identified by european working group on sarcopenia in older people (ewgsop ) criteria. the data were analyzed with use of pearson chi-square test (p< . ). results: a total of older adults were evaluated ( . % female). the mean age was . ± . years ( - y). sarcopenia was identified in . % of the sample (n= ). the frequency of unintentional weight loss in sarcopenics was % in tfi (n= ; p= . ), % in efs (n= ; p= . ), . % in pf (n= ; p= . ) and . % in mna® (n= ; p= . ). conclusion: we observed that the unintentional weight loss evaluated by tfi and efs (frailty assessment tools) was associated with sarcopenia. so, different ways to evaluate weight loss (amount and time) seems to influence this association. funding: this study was financed by fapergs (process number - / - ) and capes (finance code ). background: half of older adults admitted to hospital are malnourished. malnutrition often leads to weight-loss and may lead to a loss of muscle mass, muscle strength and physical performance. nutritional interventions should individualise nutritional requirements, particularly energy and protein. objectives: to assess if energy requirements, determined by indirect calorimetry compared to usual care (predictive equations), can lead to a reduction in weight loss (primary outcome) and improvements in muscle mass, muscle strength and physical performance (secondary outcomes) in geriatric rehabilitation patients at risk of malnutrition. methods: geriatric rehabilitation inpatients were derived from the resort cohort (royal melbourne hospital, australia) and allocated by wards to either the indirect calorimetry or usual care group for the need study. energy requirements were measured using indirect calorimetry; the results were utilised by dietitians in the indirect calorimetry group and concealed for the usual care group. weights were obtained weekly. food intake assessment, muscle mass (bioelectrical impedance analyser), handgrip strength (hgs) and physical performance (short physical performance battery (sppb)) were measured at admission and discharge. within-group and betweengroup differences were calculated for the changes in outcome measures during hospitalisation. results: twenty-one patients (indirect calorimetry n= ; usual care n= ) were included (mean age . ± years; males, females). preliminary results showed that in the indirect calorimetry group, five patients gained weight, four patients maintained weight and one patient lost weight during hospitalisation; the usual care group had four patients with weight gain and five patients maintaining weight. there were no significant within-group differences or between-group differences for changes in weight ( background: many older people have difficulties in performing daily living activities such as preparing meals and food shopping, which could be partly due to cognitive and physical decline [ ]. these factors may influence food choice and represent a potential barrier to achieving good nutrition [ ] . nevertheless, the association between mealrelated difficulties and nutritional risk, as well as dietary intake, has been understudied. objectives: ( ) to examine the prevalence of autonomy in food-related activities, as measured with instrumental activities of daily living scale (iadl), among frail and pre-frail older subjects with an objective cognitive impairment ( ) to characterize the association of food autonomy with an insufficient dietary intake and nutritional risk of cognitive frail older people. methods: this is a secondary cross-sectional analysis using baseline data from the cogfrail study, which is a monocentric observational study of cognitive frail and prefrail older participants, aged >= years, with an objective cognitive decline. dietary intake is evaluated with a dietitian, using a diet history method. autonomy in food-related activities is assessed using iadl scale. nutritional status was categorized according to the mini nutritional assessment (mna). results: ongoing analyses. preliminary results show a mean energy intake of less than kcal and g of protein per day, we considered all nutritional needs cannot be covered under this threshold. conclusion: frail older people, with cognitive impairment, are particularly at nutritional risk and insufficient dietary intake. food autonomy has to be evaluated systematically to prevent nutritional risk in this population. elderly aged years or over, and this number will continue to increase. in order to extend the healthy life expectancy, disease prevention and health management of the elderly are important. preventive intervention of sarcopenia is considered to be an important issue in promoting care prevention for the elderly. objectives: the purpose of this study was to clarify the relationship of muscle weakness and physical characteristics with nutritional intakes. methods: subjects were men and women ( to years old) in the nagoya longitudinal study for healthy elderly (nls-he) in , excluding those who had missing values of the examinations. nutritional intakes were assessed by the food frequency questionnaire (ffq). low grip strength (gs) was diagnosed by asian working group for sarcopenia (awgs) criteria. the cut-off value of gs was kg for men and kg for women. results: the number of the subjects diagnosed with low gs was , ( men and women). comparison was made between the low gs group and the normal group. there were no significant differences between the two groups in age, sex, number of teeth, chewing ability and occlusal force, whereas mini nutritional assessment (mna) score, walking speed at the normal and maximum speed, exercise habits, and percent of body fat were significantly lower in the low gs group than the normal group. also, the rate of polypharmacy was significantly higher. in nutritional intakes, vitamin d and b were significantly lower in the low gs group. in the intakes by food groups, fish and meat intakes were significantly lower, but the intakes of snack were significantly higher. furthermore, the protein ratio and the amount of animal protein intakes were significantly lower in the low grip strength group. conclusion: in this study, muscle weakness was related to lower intake of specific nutrients such as vitamin d, b , and animal protein, independent of number of teeth, chewing ability, and occlusal force. background: the status of calcium intake, the main mineral of the bone has no suitable biomarker to assess it. its evaluation is relevant in clinical practice as in research. postmenopausal women should be evaluated for risk factors for osteoporosis, including poor calcium intake. objectives: to develop and validate a food frequency questionnaire (ffq) to assess the calcium intake of mexican postmenopausal women. methods: after obtaining approval from the institutional ethics committee, a pilot study was performed including mexican women whose calcium intake was assessed trough a day food diary ( dfd). the ffq was designed including the foods reported by the participants of the pilot study that provided more than . % of the calcium requirement and that were reported by at least participants. the ffq was tested through a validation study that included postmenopausal whom also completed the dfd. the validity of the ffq was assessed with the interclass correlation coefficient (icc) alongside a bland-altman analysis. results: postmenopausal women were assessed from june , to january , . participant's characteristics are shown in the table . the ffq underestimated mean calcium intake compared to day food diary (- mg ± . , p< . ). the two methods were strongly correlated by the icc (icc= . , ci . - . ). the ffq could identify individuals who consumed >= mg/ day with a high sensitivity, and a reasonable specificity (table ). figure shows the agreement between the dfd and the ffq were plotted against the average of the two measurements (figure ), the mean (solid line) and the % ci (broken lines) of the difference are shown. conclusion: conclusions: the ffq´s good sensitivity in identifying low calcium intake in postmenopausal women makes it useful also as an educational tool in diet counselling and for identifying subjects in need of supplementation. the difference between methods limits its utility as an epidemiological tool. helen yl chan , winnie kw so , regina cheung , kc choi , brenda ho , francis li , ty lee , janet wh sit , martin mh wong , sy chair ( ( ) background: nutritional status has been recognized as a predictor of the level of frailty. however, little is known about how the eating habits and dietary preferences associated with frailty, especially in the chinese elderly population. objectives: this study aims to identify dietary factors in predicting frailty among community-dwelling older adults. methods: a multicentre cross-sectional correlational study was conducted in hong kong in . frailty was defined by using fried's phenotype model. the frail scale was used to classify level of frailty and the mini-nutritional assessment (mna) was used to evaluate the nutritional status, in addition to anthropometric parameters. association between nutritional status (at risk or malnourished vs normal) and frailty status was examined using ordinal regression in a hierarchical fashion for adjusting participant socio-demographics, health status, lifestyle characteristics, eating behaviours and dietary habits. all the statistical analyses were performed using ibm spss . . all statistical tests were two-sided with level of significance set at . . results: a total of chinese older adults participated in the study. the prevalence of robust, pre-frail and frail were . %, . % and . % respectively. one third of the participants were malnourished or at risk of malnutrition. malnutrition and at-risk of malnutrition significantly increased the likelihood of frailty (or . , % ci . - . ). however, the level of frailty was not associated with age, gender, anthropometric measurements, eating behaviours, and use of dietary supplements. other nutritional factors significantly increased the likelihood of frailty were chewing difficulties (or . , % ci . - . ) and inadequate consumption of vegetables (or . , % ci . - . ). however, good appetite significantly reduced the likelihood of frailty (or . , % ci . - . ). conclusion: the findings showed that chewing difficulties and inadequate consumption of vegetables were associated with frailty, whereas good appetite was a protective factor. hence, interventions for addressing chewing problem and promoting appetite and consumption of vegetables are imperative to counter frailty in the older population. lack of energy was associated with nutritional status in nursing-home (nh) residents. methods: we performed a cross-sectional analysis of the incur study cohort. lack of energy was measured at baseline as part of the -items geriatric depression scale. nutritional status was evaluated according to mini nutritional assessment short-form (mna-sf). a -items frailty index (fi) was computed. logistic regression models were performed to test the association of lack of energy with nutritional status. results: a total of nh residents were available for analysis. the median age (iqr) was ( - ) years, with ( . %) females. at baseline, median mna-sf (iqr) was ( - ) with ( . %) patients that were malnourished. among the patients included . % ( patients) reported lack of energy. at univariate logistic regression analysis mna was inversely associated with lack of energy. at multivariate logistic regression analysis, adjusted for age, sex nursing home years and fi, we found that mna was independently inversely associated with lack of energy (or . , % ci . - . ). being malnourished is independently associated with lack of energy (or . , % ci . - . ). among mna components we found that item a (decrease in food intake), item c (reduced motricity) and item d (psychophysical stress) were inversely associated with lack of energy (or . , % ci . - . ; or . , % ci . - . ; or . % ci . - . ; for each point respectively), independently each one and from the other confounders. conclusion: in a cohort of very old nh residents, we found that an impaired nutritional status is associated with lack of energy. in particular, being malnourished bring a -fold risk of reporting lack of energy. more precisely, decrease in food intake, reduced motricity and psychophysical stress, each one were independently associated with lack of energy. a g e . m a r g u e r i t a s a a d e h , , f e d e r i c a p r i n e l l i , , anna-karin welmer , , weili xu , davide l vetrano , , serhiy dekhtyar , laura fratiglioni , , amaia calderón-larrañaga ( ( ) background: while declines in physical function are a common feature of ageing, the rate of the loss varies substantially between individuals, and has been attributed to intrinsic but also extrinsic (modifiable) factors such as diet, physical activity, and psychosocial well-being. objectives: ( ) to assess the role of food and nutrient intake in the speed of functional decline over years of follow-up. ( ) to explore whether such an association differs between levels of physical activity and psychosocial well-being. methods: we analysed data from individuals aged + from the population-based swedish national study on aging and care in kungsholmen (snac-k). the mediterranean diet score, mds (trichopoulou et al.) and the healthy diet indicator, hdi (who recommendations for saturated fatty acids, monodisaccharides, cholesterol, pufas, protein and fibre) were calculated for each participant, based on baseline data from a validated food frequency questionnaire and the corresponding transformation into nutrient intake. physical activity levels were assessed with questions about type, frequency, and intensity, and categorised as inadequate vs health/fitness-enhancing. we created a psychosocial well-being index by integrating variables linked to life satisfaction, positive/negative affect, social network and social participation. a global score of physical function was obtained by combining data on walking speed, balance, and chair stand tests. linear mixed models were used and adjusted for age, sex, education, smoking, baseline number of chronic diseases and impaired activities of daily living, total energy intake and time to death/drop-out. results: one standard deviation (sd) increase in the mds was associated with a lower functional decline both crosssectionally (β= . ; p= . ) and over the -year follow-up (β*time= . ; p= . ). higher scores of the hdi were also significantly associated with a lower functional decline, but only cross-sectionally (β= . ; p= . for one sd increase). when stratifying the analyses by levels of physical activity and psychosocial well-being, the protective effect of high mds was limited to subjects with health/fitness-enhancing physical activity (β*time= . , p= . ) and high levels of psychosocial well-being (β*time= . , p= . ), respectively. conclusion: a high adherence to a mediterranean dietary pattern, especially in combination with higher physical activity and psychosocial well-being, may slow down the age-relate decline in physical function. background: this cross-sectional study describes the application and follow-up of the self-care actions applied in a white male, years old, . m tall, a former athlete, currently sedentary, who in january presented % of glycated hemoglobin in medical consultation -between . and . %: pre-diabetes; fasting glycemia (mg / dl); (mg /dl) and the postprandial dose between and mg / dl. blood pressure between - mmhg; characterizing hypertension in stage. objectives: the objective was applying and follow-up a food re-education program associated with a resistance training program to reduce non-communicable diseases. methods: during , a program of dietary reeducation was carried out, with a few complex carbohydrates, an increase in proteins of high biological value, associated with a program of resistance exercises, which was adapted and individualized, obeying the individual's particularities. a short physical performance battery (sppb) was also applied to assess walking speed, strength and muscle balance. this program was performed three times a week, under the supervision of a physical education professional. capillary blood glucose was collected and analyzed times and blood pressure times, respectively. it was carried out a basic training for weeks aiming to rescue the muscular memory of the elderly, after beginning the adaptive phase of the physical valence training (cardiovascular endurance, localized muscular resistance); for weeks and the specified. the loads corresponded to % of rm for - repetitions with three series and to minutes intervals at each stage of the training. we used the ibm spss statistics program to perform descriptive statistics. results: the mean glycemia was (mg / dl), the glycated hemoglobin analyzes showed . ; low risk of diabetes. systolic blood pressure and diastolic blood pressure presented a mean of . ± . mmhg, and . ± . mmhg, respectively. we observed a gradual gain every months of resistance training. the sppb score changed from to points; performance between intermediate to high. conclusion: dietary re-education associated with a well-designed strength training program can result in the reduction of diabetes and hypertension, as well as strengthening the muscular system of the elderly. background: diet can be an important non-pharmacological aspect in order to prevent and/or attenuate brain and frailty outcomes in older adfults. objectives: to investigate, by a systematic review, studies associating the dietary inflammatory index (dii) with brain and frailty outcomes in older adults. methods: we searched the publications in pubmed and lilacs databases up to june . inclusion and exclusion criteria were formulated based on pi(e)cos strategy (population= older adults, >= years; intervention/ exposition= dietary inflammatory index; comparison= not applied; outcomes= brain and muscle outcomes; study type= randomized clinical trials, cohorts, cross-sectional, casecontrol studies). results: searches resulted in publications, and after exclusion due to duplicity (n= ) and not compliance with exclusion and inclusion criteria (n= ), eight studies were selected. these studies were published from to , all of them were cross-sectional, with participants above years old, and the outcomes investigated were frailty and frailty risk, survival free of disabilities (by fried's frailty criteria, sppb test, lawton and broady scales); memory, cognitive decline and risk of dementia (by meem, cerad, gds, prime-md, dsst and animal fluency test). conclusion: the data extracted from the articles showed significant association between dii and the outcomes investigated, namely, the more inflammatory diet was associated with higher odds to be frail and pre-frail, and to have any type of cognitive impairment. therefore, the dii showed to be associated to brain and frailty outcomes in older adults, however, to understand causality, longitudinal studies are still necessary. background: it is well established that reactive oxygen species (ros) are increased in skeletal muscle with age. we have recently shown that increased ros with age is associated with increased expression of the senescence-associated microrna mir- a- p (mir- a) in skeletal muscle as well as in muscle-derived extracellular vesicles. these vesicles enriched in mir- a are elevated in aged mouse serum, and can induce senescence in bone stem cells. the histone deacetylase sirt is a validated target of mir- a, and sirt plays important roles in cell survival as well as in muscle hypertrophy with functional overload. importantly, we previously found that mir- a expression was much higher in muscle from aged female mice compared to male mice, a phenomenon others have observed in mouse cardiac muscle. objectives: here we tested the hypothesis that pharmacological ablation of senescent cells could modulate mir- a and sirt bioavailability in skeletal muscle of aged mice. we utilized the senescent drug abt- (navitoclax) since previous studies have shown that oral administration of abt- removed senescent satellite (stem) cells in mouse skeletal muscle. methods: ten male and ten female c bl mice, months of age, received either abt- ( mg/kg bw, ul) or vehicle by oral gavage for ten days. tibialis anterior muscles were removed at the end of the study for examination of mir- and sirt levels using rt-pcr and elisa, respectively. results: abt- reduced mir- a expression in both male and female mice, although the effect was more pronounced in male mice compared to females. abt- significantly increased sirt levels in male skeletal muscle but not in females. the changes in sirt and mir- a levels were not associated with significant differences in muscle fiber size over the treatment period. conclusion: these findings suggest that certain senolytic compounds can modulate levels of senescence-associated mirnas and their targets in aging skeletal muscle. these data also underscore the importance of considering sex differences in the molecular mechanisms underlying age-related muscle atrophy. background: the growth of the elderly population is a worldwide phenomenon and is associated with profound changes in body composition. the purpose of this study was to describe the magnitude of the problem, to evaluate the associated factors and the relation with functional capacity in the study population. objectives: to estimate the association between demographic factors, comorbidities and muscle mass index over time until functional disability or death appears in non-obese elderly individuals. methods: longitudinal study of elderly individuals aged years or over, non-obese and absence of functional disability at the beginning of the cohort on the epidoso project database. the variables gender, age, ethnicity, medical history, functional capacity and death were investigated. the low or normal muscle mass index (mmi) was obtained through anthropometric data and a predictive equation. the functional capacity was measured using a structured and validated multidimensional questionnaire. the deaths occurred in the period were investigated with relatives through household surveys, in registries and registries of the state system of data analysis foundation. estimates of eventfree survival (functional disability or death) were calculated using kaplan-meier curves using the log-rank test in the gross comparisons. a multiple cox proportional hazards model was used to identify the independent effect of time predictors until onset of functional disability or death. results: the mean time found for the onset of functional disability or death was . years ( %ci=[ . ; . ]). in the crude analysis, there were statistically significant differences in the time to occurrence of functional disability or death, by age group (p< . ), arterial hypertension (p= . ), diabetes mellitus (p= . ) and marginal statistical difference muscle mass level (p= . background: a consequence of the ageing population is the increasing number of older adults with physical limitations. these limitations are mainly caused by decreased muscle mass and strength (sarcopenia). treatment or rather prevention of sarcopenia is necessary, as it may lead to lowered quality of life, hospitalization, loss of independence and even mortality. since older ethnic minorities are more likely to have an unfavourable health status compared to the majority population, variations in the prevalence of sarcopenia for ethnic minority groups are expected. further investigation seems imperative to be able to target preventive interventions to those at high risk of sarcopenia within the population. objectives: to examine the sarcopenia prevalence and its association with protein intake in an older multi-ethnic population in the netherlands. methods: we used cross-sectional data from the helius (healthy life in an urban setting) study, comprising the largest ethnic populations living in amsterdam, the netherlands. in total individuals from dutch, south-asian surinamese, african surinamese, turkish and moroccan origin aged years and over were included. sarcopenia was defined according to the ewgsop . in a subsample (n= ), protein intake was measured using ethnic-specific food frequency questionnaires. descriptive analyses were performed to study sarcopenia prevalence across ethnic groups in men and women, and logistic regression analysis were used to study associations between protein intake and sarcopenia. results: sarcopenia prevalence was found to be sex-and ethnic specific, varying from . % in turkish to . % in south-asian surinamese men and ranging from . % in turkish up to . % in south-asian surinamese women. higher protein intake was associated with a % lower odds of sarcopenia in the total population (or= . , % ci . - . ) and across ethnic groups. conclusion: ethnic differences in the prevalence of sarcopenia and its association with protein intake suggest the need to target specific ethnic groups for prevention or treatment of sarcopenia. background: few studies have evaluated the relationship between frailty and acute respiratory illness (ari), despite of increasing heavy burden of ari in older people. objectives: we conducted a prospective cohort study in communitydwelling older people in hong kong, to evaluate the impact of frailty on the risk of acute respiratory infections in the community setting and the potential modifying role of outdoor activities. methods: we recruited and followed up participants who were chinese and aged from to years, from december to may . frailty was measured by fried frailty index (ffi) twice during the study period. daily hours of outdoor activities were collected by a monthly activity journal (n= ) during the whole period, and by wearable gps device from some participants for one week in summer (n= ) and winter (n= ), respectively. the ari incidence was collected by monthly phone calls to the participants. we used a logistic regression model to estimate the odds ratio (or) of ari associated with frailty status (robust as reference group). results: the participants were classified into three groups according to the ffi criteria: ( . %) as robust, ( . %) as pre-frail and ( . %) as frail groups. of them, reported ari during the study period. according to the activity journals, daily hours of staying outdoors in the ari participants were slightly less than those in without ari ( . vs . in whole study period, . vs . in summer, . vs . in winter). while, the gps data showed that the participants with ari had longer daily hours of outdoors activities in summer ( . vs . ) but shorter in winter ( . vs . ), although none were statistically significant (p > . ). after adjustment for age, age, living alone or with family and daily hours of outdoor activities, we found that the frailty and pre-frailty groups had a higher risk of ari incidence compared with the robust group, with or . (p = . ) and . (p = . ), respectively. conclusion: frailty might be associated with a higher risk of ari among older people, but the role of outdoor activities remains inconclusive. background: previous studies have investigated the association between impaired muscle health and mortality. however, muscle health is a dynamic entity which change with time. objectives: to assess the effect of a short-term decline of muscle health (i.e., over year) and its association with long-term mortality (i.e., over years). methods: the sarcophage cohort follows up older belgian adults to assess consequences of sarcopenia. an assessment of muscle mass (dxa), muscle strength (handheld dynamometer) and physical performance (by means of sppb, including gait speed) are performed annually. all-causes deaths are collected annually. the association between short term (i.e. after one year) decline in muscle parameters and -year occurrence of deaths was tested using cox model. roc analyses were performed to assess performance of prediction of the different muscle components and to find optimal cut-points. missing data were handled using multiple imputations. results: from the subjects recruited ( . ± . years, . % women), were discarded from our sample because they died during the first year. therefore, the muscle decline was available on a sample of subjects. deaths occurred within the first years of follow-up. a -point decrease in performance at sppb test resulted in % higher risk of dealth (hradjusted = . [ %ci . - . ]). for each decrease of . m/s of gait speed, we observed an % higher risk of death (hradjusted = . [ . - . ]). a -kg decrease of muscle strength resulted in % higher risk of death in men and % higher risk of death in women (hradjusted = . [ . - . ] and hradjusted = . [ . - . ], respectively). we did not found any association between short-term loss of muscle mass and the occurrence of death (p= . ). then, we tried to find cutoffs optimizing the sensitivity-specificity ratio and we found following results : over year, a decline of sppb superior or equal to , of gait speed superior or equal to . m/s and of muscle strength superior or equal to . kg in men and . kg in women. conclusion: a short-term decline in muscle function is predictive of premature deaths. background: sarcopenia, the age-related progressive loss of muscle mass and function, is associated with an increased likelihood of adverse outcomes like falls, fractures, physical disability, and mortality. international consensus groups continue providing new definitions and clinical cut-off points despite over a decade of work in this area. objectives: we examined the prevalence of sarcopenia using two of the most current operational definitions (foundation of nih sarcopenia project (fnih) and the european working group on sarcopenia in older persons (ewgsop )) in a cohort of older adults (n= , >= yrs) hospitalized for an acute disease at utmb hospital in galveston (jan -may ). methods: testing included measures of: demographics (age, gender, race, education), body composition (dexa), physical function tests (sppb, tug, grip), psychological wellbeing and independence questionnaires, and chart review (comorbidity, length of stay). results: we found % had low physical performance, % had low muscle strength, and % low lean mass. we compared multiple tests and cutoffs for each of the three groupings under the fnih and ewgsop and found there to be differences depending on the test usedespecially for low performance which varied from %- %. in our cohort, the prevalence of sarcopenia was . % by ewgsop and . % by fnih. the subgroupings were found to be near identical across almost all measures despite the definitions' discrepancies in cutoff points between fnih and ewgsop . conclusion: in conclusion, recent updates to the new ewgsop make it almost indistinguishable to the older fnih standard, but the new ewgsop algorithm does provide a grading system to identify different levels of severity of sarcopenia. background: the population is experiencing a fast growth in the number of older adults, therefore determine the prevalence of frailty could help to inform future strategies to reduce its social and health burden. objectives: determine the prevalence of frailty in chilean older adults. methods: participants, aged > years, from the chilean national health survey - were included in this study. frailty was assessed by fried criteria modified, therefore people classified as frail should meet at least out of the criteria (low strength, low physical activity, low body mass index, slow walking pace and tiredness). results: the prevalence of frailty was . % ( . % for men and . % for women). the prevalence of prefrailty was . % whereas . % was classified as normal. the prevalence of frailty increased with markedly with age, . % and . % of men and women, respectively, were frail at the age of . this prevalence increased to . % and . % for men and women at the age of . the prevalence of pre-frailty increased from . % to . % for men and from . % and . % for women from the age of to years, respectively. conclusion: the prevalence of frailty increased markedly with age. with the chilean population expected to increase their life expectancy and number of older adults, it is important to implement prevention strategies that allow for early identification of high-risk individuals. a year follow-up. jair licio ferreira santos , yeda aparecida de oliveira duarte , tiago da silva alexandre background: sarcopenia has been increasingly recognized as leading to poor prognosis in health outcomes. likewise, falls -although important at older ages -have not been studied frequently and may lead to an increased risk of death. we evaluated survival of elderly people living in são paulo -brasil in a -year follow-up, considering the presence of sarcopenia at baseline and the occurrence of falls before the interview. objectives: to investigate whether sarcopenia and/or falls increase mortality among brazilian older adults. methods: data came from the second ( ) and fourth ( ) rounds of the health, welfare and aging study (sabe), which begun in , with a sample of the population over years old in the city of são paulo, brazil. after the first round, follow-up was performed every five years. sarcopenia was defined according to the consensus of the european working group on sarcopenia in the elderly (ewgsop), and the occurrence of falls was assessed by direct questions answered by the elder or his caregiver. a multivariate analysis with robust estimation and control for exposure time was done using the poisson regression model. results: mortality rates (per thousand person years) were: . (non sarcopenic, no falls) ; . (non sarcopenic with falls); . (sarcopenic no falls) ); and . (sarcopenic with falls. the poisson regression resulted in incidence rate ratios (when compared to sarcopenic, no falls) of . for non sarcopenic with falls; . for sarcopenic elders with no falls and . for sarcopenic with falls. conclusion: sarcopenia and the occurrence of falls are important risk factors for mortality. this finding highlights the importance of considering sarcopenia in health risk assessment and developing educational programs to prevent falls. ecosse l. lamoureux, , , alfred t.l. gan , ryan e.k. man , , eva k. fenwick , , bao lin pauline soh , angelique chan , david ng , chong foong-fong mary , preeti gupta (( ) singapore eye research institute and singapore national eye centre, singapore; ( ) duke-nus medical school, singapore; ( ) singapore institute of technology, health and social sciences, singapore; ( ) saw swee hock school of public health, national university of singapore, singapore) background: individually, sarcopenia and frailty are known risk factors for cognitive impairment (ci) in older adults, but information on their conjoint presence on the increased risk of ci is unavailable in this same population. objectives: we examined the association of the combined presence of sarcopenia and frailty with ci in elderly singaporeans. health profile in elderly singaporeans study (pioneer), a nationally-representative, population-based study of singaporean chinese, malays, and indians aged >= years. participants underwent body composition (dual energy x-ray absorptiometry -dxa); grip strength (hand dynamometer) and habitual m-walking speed assessments. sarcopenia was defined using the asian consensus as low appendicular lean mass (lalm; men < kg/m , women < . kg/m ) and low muscle strength (lms; men < kg, women < kg) or slow walking speed (sws; < . m/s); and frailty was defined as meeting three or more of the following components: ) unintentional weight-loss >= . kg in the past - months and/or bmi < . kg/m , ) lms, ) self-reported exhaustion in the past one month, ) sws, and ) low physical activity level. ci was determined using the montreal cognitive assessment (moca) basic scale. logistic regressionb models were used to determine the cross-sectional sarcopenia-frailty and ci relationship. results: of the included participants (mean age [sd]: . [ . ] years; . % females), ( %); ( %); and ( %) had neither sarcopenia nor frailty, either sarcopenia or frailty, and both sarcopenia and frailty, respectively. ci was present in ( . %) individuals without sarcopenia and frailty; ( . %) with either sarcopenia or frailty; and ( . %) individuals with both sarcopenia and frailty. in multivariable-adjusted analyses, presence of either sarcopenia or frailty was not significantly associated with higher odds of ci (odds ratio (or) [ % confidence interval]: . [ . - . ]), while having both sarcopenia and frailty significantly increased the odds of ci by nearly . times ( . [ . - . ]). conclusion: the co-presence of sarcopenia and frailty is independently associated with a higher risk of ci, compared to one condition alone, although longitudinal studies are needed to confirm this finding. strategies to prevent the concomitant onset of sarcopenia and frailty may be warranted to potentially reduce the risk of ci in older adults. background: car accidents related to older adults increased with aging, particularly in japan. safety driving required robust of physical function. however, the association between frailty and car accidents was still unclear. objectives: the aim of this study was to examine the association between frail status and car accidents. methods: participants were , older adults ( . % women, mean age: . years) enrolled current drivers in the national center for geriatrics and gerontology -study of geriatric syndromes. the criterion of frailty used in this study was j-chs index modified according to fried's criteria (chs index). the components of frailty in j-chs index were based on the original chs index: shrinking (weight loss), weakness, poor endurance (exhaustion), low activity level, and slowness. based on the presence numbers of these five components, our study defined "frailty" as and over, i.e., including pre frail and frail. the data of car accidents were collected from self-reported history of car accidents during years. results: among , participants, , participants ( . %) had a history of car accident. higher proportion of car accidents group was observed in shrinking ( . % vs . %, p = . ), exhaustion ( . % vs . %, p = . ), physical inactivity ( . % vs . %, p = . ) and slowness ( . % vs . %, p = . ), but not weakness ( . vs . , p = . ). in a logistic regression analysis, frailty was independently associated with car accidents in an adjusted model (or . [ %ci . - . ], p < . ). conclusion: this population study reveals frailty associated with car accidents. the findings have contribution of enhancing utility of risk assessments among older drivers. further studies were required to clarify risk of car accidents.model. background: frailty, a state of vulnerability to stressors resulting from a loss of physiological reserve across multiple systems. frailty is associated with higher morbidity, mortality and healthcare utilization. the national prevalence of frailty among us older veterans was found to be as high a %. however, little is known about the incidence of frailty in older, community-dwelling veterans. objectives: determine the incidence over years of frailty among robust or prefrail community-dwelling older veterans. methods: this is a retrospective cohort study of community-dwelling veterans years and older who had determinations of frailty from july -june and were followed until their last clinician visit before september , . a -item va frailty index (va-fi) was generated at baseline and during each subsequent primary care encounter as a proportion of all potential variables (morbidity, function, sensory loss, cognition and mood and other) with data from electronic health records. the va-fi categorized veterans into robust (fi<. ), prefrail (fi=>. , <. ) and frail (fi>=. ). using baseline and median duration of follow-up data based on event rates, incidence rates of frailty per person/years were calculated for robust, prefrail, combined (robust and prefrail) and gender groups. results: patients were . % white, . % non-hispanic, . % male, mean age . (sd= . ) years. the proportion of robust, pre-frail and frail patients at baseline was . % (n= ), . % (n= ) and . % (n= ) respectively. among robust veterans surviving a median follow-up of . (iqr . ) years, . % ( / ) became frail with an incidence rate of . cases/per person-years. among prefrail veterans . % ( / ) became frail and the incidence rate was . cases/per person-years. among the combined group, % became frail, with an incidence rate of . per person-years. the proportion of veterans becoming frail and the incidence rates were higher in women than men ( . % vs. . % and . vs . cases per person-years respectively). conclusion: this study shows a high incidence of frailty in community-dwelling older us veterans. identification of older veterans at high risk for frailty may assist in the development of interventions aimed at preventing frailty and its associated complications. background: anticholinergic drugs are prescribed to treat a variety of medical conditions through pharmacological actions opposing the actions of acetylcholine. anticholinergics and may contribute to frailty by causing cognitive, functional and physical impairment. frailty represents a state of vulnerability to stressors resulting from a loss of physiological reserve across multiple systems. frailty may potentially make patients more susceptible to the deleterious effects of anticholinergic medications on cognition. objectives: determine the crosssectional association of anticholinergics with cognitive impairment according to frailty status among communitydwelling older veterans. methods: this is a cross-sectional study of , community-dwelling veterans years and older whose frailty status was assessed october -october . the use of medications (active/inactive) with high anticholinergic burden scale (acb ) and cognitive impairment diagnoses (icd codes for mild cognitive impairment/dementia) were obtained from electronic health records. a -item va frailty index (va-fi) was generated as a proportion of all potential variables at the time of the assessment. we compared robust (fi≤. ), prefrail (fi=>. , <. ) and frail (fi>=. ) patients. after adjusting for age, gender, race, marital status, median household income, and bmi, odds ratios (ors) and % confidence intervals (cis) were calculated using binomial logistic regression with cognitive impairment as the outcome variable and anticholinergics (acb ) as independent variables. we repeated the analysis according to frailty status. results: patients were % white, . % male, mean age . (sd= . ) years, . % ( ) had cognitive impairment, . % (n= ) were taking acb medications, . % ( ) took them in the past and . % ( ) never used them. the proportion of robust, pre-frail and frail patients was . % (n= ), . % (n= ) and . % (n= ) respectively. in binomial logistic regression, active and inactive acb medications were associated with higher risk for cognitive impairment, adjusted or= . background: frailty, a state of vulnerability to stressors resulting from a loss of physiological reserve across multiple systems. the national prevalence of frailty among us older veterans was found to be as high a %. multiple studies have shown a higher prevalence of frailty and mortality in african americans. however, little is known about racial-differences in all-cause mortality in older veterans who had just transitioned to frailty. objectives: determine racial differences in allcause mortality over years among community-dwelling older us veterans who transitioned to frailty. methods: this is a retrospective cohort study of , community-dwelling veterans years and older who transitioned to frailty from july -september and were followed until death or september . a -item va frailty index (va-fi) was generated at baseline and during each subsequent primary care encounter as a proportion of all potential variables with data from electronic health records. the va-fi categorized veterans into robust (fi≤. ), prefrail (fi=>. ,<. ) and frail (fi>=. ). at the end of follow-up, we aggregated data on mortality only on those veterans who transitioned to frailty (robust/prefrail at baseline) and compared whites and african americans. after adjusting for age, gender, ethnicity, marital status and median household income, the association of race with mortality was determined using a multivariate cox regression model. results: patients were . % white, . % african-american, . % non-hispanic, . % male, mean age at frailty transition was . (sd= . ) years. over a median follow-up period of days (iqr= ) from the time they transitioned to frailty, deaths occurred (n= , in whites vs. n= in african americans). african american veterans had a lower risk for all-cause mortality than white veterans, unadjusted hazard ratio (hr) =. ( %ci: . -. ), p<. . however, these mortality differences disappeared after adjustment for covariates, adjusted hr =. ( %ci: . - . ), p=. . conclusion: our study suggests that in community dwelling older us veterans who had transitioned to frailty, race is not significantly related to overall survival when adjusting for other covariates. background: previous studies show that sarcopenic obesity (so) is associated with higher risk of mortality. however, a consensus definition of so is lacking, and more information is needed on the validity of simple measures applicable at a regular health care visit, such as anthropometric measurements and hand-grip strength or chair stand test. objectives: to examine the association between so and mortality, defining so based on body mass index, waist circumference, hand-grip strength and chair stand test, in a representative sample of finnish population. methods: this study was based on , participants aged years or over with data on anthropometrics, hand-grip strength and chair stand test from the nationally representative health survey. baseline sarcopenic obesity was defined as having bmi >= kg/m or waist circumference >= cm (men)/ cm (women), and hand-grip strength < kg in men, < kg in women, or chair stand > s for five rises. register-based follow-up data of the statistic finland containing , deaths during the years of follow-up were individually linked with the baseline data. survival analyses were based on cox proportional hazards models using age as the time scale. results: mean age was . years (sd . ) and . % were females. overall prevalence of sarcopenic obesity was . % at baseline. sarcopenic obesity was associated with higher risk of mortality (hr . , %ci . - . ) in an age and sex adjusted model. further adjustments for education, smoking, alcohol use, and physical activity did not notably change the results (hr . , %ci . - . ). conclusion: sarcopenic obesity, as defined based on anthropometric measurements as well as hand-grip strength or chair stand test, predicted higher mortality over years of follow-up. background: malnutrition and sarcopenia have a negative impact on mobility, risk of falls, fractures, physical disability and mortality. currently, limited information is available on nutritional status and nutritional interventions in geriatric rehabilitation (gr) patients. objectives: to characterize nutritional status and evidence of nutritional interventions with and without physical exercise in gr patients. methods: eight electronic databases were screened for nutritional status and interventions in patients >= years, admitted to gr, one search string was used for both topics. pooled estimates were calculated for mean bmi and prevalence of (risk of) malnutrition (mna). meta-analyses were performed to quantify intervention effects on albumin, muscle mass, barthel index (bi), and hand grip strength (hgs). results: observational and intervention studies were included out of references. pooled estimates ( % confidence interval (ci)) for prevalence of malnutrition and risk of malnutrition were ( - )% and ( - )%. pooled estimate ( %ci) for bmi was . ( . - . ) kg/m². low protein and energy intake and vitamin d deficiency were prevalent. intervention studies were heterogeneous in interventions and outcomes. meta-analyses showed no significant effects on albumin (standardized mean difference (smd) . , % ci - . : . ), muscle mass (mean difference (md) . kg, % ci - . : . ), bi (md . points, % ci - . : . ) and hgs (smd - . , % ci - . - . ), based on - studies. eight interventions tested oral nutritional supplements (ons) with protein, with or without exercise, reported protein intake and showed an increase, / studies showed increased albumin levels and / reported improved functional outcomes. conclusion: a high percentage of gr patients was affected by reduced nutritional status. intervention studies were limited and heterogeneous, but studies with ons improved nutritional outcomes, and functional outcomes in the majority of reporting studies. the results emphasize the need for malnutrition and sarcopenia screening and show benefits of protein supplementation in this population. future well-designed, well-powered trials are needed to clarify existing controversial aspects. therefore, feasibility of an intervention with a high-whey protein, leucine and vitamin d enriched ons (fortifit®), combined with resistance-type exercise in gr hip fracture patients will be investigated in a new intervention study (empower-gr). background: sarcopenia is a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes such as falls, fractures, physical disability and mortality. the geographical region of residence (urban and rural area) may affect the prevalence of sarcopenia due to physical and environmental conditions. in , the european working group on sarcopenia in older people (ewgsop) updated the definition of sarcopenia (ewgsop ). objectives: to describe the prevalence of sarcopenia related to ewgsop and ewgsop criteria and to analyze the association between sarcopenia and geographical regions of residence. methods: this is a cross-sectional study involving elderly women ( years old or more) that were undergoing dxa in a radiology facility located in palmeira das missões (southern brazil). sociodemographic data were collected through a questionnaire. for the diagnosis of sarcopenia, we used the criteria recommended by the ewgsop (low muscle mass plus low grip strength and/or low gait speed), and ewgsop (low grip strength plus low muscle mass and/or low gait speed). the study was approved by the university ethics committee. results: out of the participants, . % was married, . % had education between and years of schooling, . % was caucasian, and . % was retired. the mean age was . ± . years old ( - ). the frequency of sarcopenia in the total sample assessed by the ewgsop and ewgsop was . % and . %, respectively. the prevalence of sarcopenia by the ewgsop was % in the urban area and . % in the rural area (p= . ) and by the ewgsop was . % in the urban area and . % in the rural area (p= . ). conclusion: in a sample of elderly women from the southern brazil, the prevalence of sarcopenia was low through both consensus (ewgsop and ewgsop ), and was higher among urban area. funding: this study was financed in part by the coordenação de aperfeiçoamento de pessoal de nível superior -brazil (capes) -finance code . background: patients with disuse syndrome have gradually increased with aging of inpatients in saitama medical university hospital. because these patients have been inactive in the acute phase, sarcopenia is likely to occur. sarcopenia was graded by three criteria in ewgsop ; muscle strength, muscle quantity and physical performance. muscle volume can be measured only in limited medical centers. many of patients with disuse syndrome can not walk even after the acute phase. for these reasons, muscle strength is the only quantitative factor reflecting sarcopenia, especially in old patients with disuse syndrome after the acute phase. objectives: to show ) muscle strength in old patients with disuse syndrome after the acute phase, ) effect of muscle strength on activities of daily living (adl). methods: subjects were old patients with disuse syndrome admitted in the department of rehabilitation medicine (rm) in saitama medical university hospital from january to december . inclusion criterion were as follows; ) patient age was or older ) patients could not walk independently at admission in the department of rm exclusion criterion were as follows; ) patients with motor paresis, contracture of fingers ) patients in inactivity before the onset of the disease causing disuse syndrome. grip strength (gs) was measured by handheld dynamometer. cut-off point of gs set by awgs in was adopted; kg for men and kg for women, adl was evaluated using functional independence measure motor scale (mfim) one week after admission in the department of rehabilitation medicine . percentage of gs below cut-off point was shown in men and women respectively. effect of gs on mfim was investigated using regression analysis. results: ninety nine out of patients were subjects in this study. median age was . years in men (n= ), . years in women (n= ). only two in men and one in women were below gs cut-off point. correlation coefficient between gs and mfim was . (p= . ) in men, . (p= . ) in women respectively. conclusion: gs was below cut-off point in most of the subjects. gp may affect adl after the acute phase in old patients with disuse syndrome. death, whereas measures of functional ability, physical strength and morbidity were stronger associated with time to death than with chronological age. from the age of and forwards participants have a high life-satisfaction in general, however, a decline is seen as persons get older and with proximity to death. measures of functional ability (e.g. going shopping) and morbidity (e.g. self-related health) had a significantly increasing effect on life-satisfaction with increasing age. whereas social function (e.g. living alone, meeting friends) did not significantly modify the decrease in life satisfaction with increasing age. conclusion: physical strength, functional ability and morbidity were measures mostly linked to biological aging, while social functioning was strongly correlated with chronological age. functional ability and self-related health are important factors to prevent age-related decrease in life satisfaction. background: previous studies mostly conducted in western countries support that physical frailty predicts future cognitive decline in general older populations. however, longitudinal evidence on this association is limited, especially among older japanese women. objectives: this study has investigated the prospective associations of frailty status with cognitive decline over two years among community-dwelling older japanese women, including which individual frailty components (i.e., slowness, weakness, exhaustion, low activity, and unintentional weight loss) could predict cognitive decline. methods: this study was a two-year population-based cohort study conducted in a metropolitan area of tokyo, japan. data were collected in october (baseline) and september (follow-up) and analyzed between december and january . participants were community-dwelling older japanese women, aged to years at the baseline, without any neurological diseases or cognitive impairment as measured by a mini-mental state examination (mmse) score of >= points. cognitive decline was defined as a drop of two points or more in the mmse score over two years. the physical frailty phenotype was classified by the japanese version of cardiovascular health study criteria. multiple poisson regression analyses with a robust error variance were applied to assess risk ratios (rrs) of two-year cognitive decline across the baseline frailty statuses (robust [reference category], prefrail, or frail). results: of the women analyzed, ( . %) were prefrail ( or components), and ( . %) were frail (≥ components) at the baseline. at the follow-up, ( . %) robust, ( . %) prefrail, and ( . %) frail women experienced cognitive decline. after being adjusted for various confounding factors including age, educational attainment, and baseline mmse score, the rrs of cognitive decline were . ( % confidence interval [ci]: . , . ) in the prefrail and . ( %ci: . , . ) in the frail women. among the five frailty components, slowness (rr: . , %ci: . , . ), weakness (rr: . , %ci: . , . ), and unintentional weight loss (rr: . , %ci: . , . ) were significantly associated with cognitive decline. conclusion: over the two-year period, approximately % of women experienced cognitive decline. baseline physical frailty status, particularly slowness, weakness, and unintentional weight loss, predicted this decline. intervention strategies targeting physical frailty may help delay cognitive decline in older japanese women. background: menopause leads to estradiol (e ) deficiency that is associated with decreases in muscle mass and strength. yet the mechanistic role of e in the loss of muscle mass has not been established. programmed cell death termed apoptosis has been proposed a key signaling route in skeletal muscle homeostasis, including muscle aging and sarcopenia. to date several micrornas (mirs) have been found to regulate key steps in apoptotic pathways. objectives: here we studied the effect of e deficiency on mir-signaling in skeletal muscle apoptosis. our aim was to reveal whether e -responsive mirs have mechanistic role in inducing skeletal muscle apoptosis. methods: we utilized c bl mice with three study groups; sham (normal estrous cycle, n= ), ovx (e deficiency, n= ) and ovx+e (high e supplemented by pellet, n= ). in our setup, ovx and ovx+e groups represent the extremes of e level. six weeks following the sham or ovx surgery, mice were sacrificed, gastrocnemius muscles were harvested and rna isolated. mir-profile was studied with ngs and candidate mirs verified using qpcr. the target proteins of the mirs were found using in silico analysis (target scan) and target proteins measured at mrna (qpcr) and protein levels (western blot). results: of the apoptosis-linked mirs found, four ( - p, a- p, - p and - p) indicated differential expression patterns between ovx and ovx+e groups. in qpcr verification, ovx had lower expression in all of the studied mirs compared with ovx+e (p= . ). accordingly, ovx had higher expression of cytochrome c and caspases , and compared with ovx+e at the mrna level (p< . ). at protein level, ovx had greater cytochrome c and active caspase compared with ovx+e (p< . ). conclusion: in muscle from e deficient mice (ovx vs. ovx+e group), several apoptosis-linked mirs were down regulated concomitant with higher mrna expression of the target proteins. furthermore, e deficiency was associated with higher cytochrome c and active caspase protein levels. to conclude, e deficiency down regulated several mirs related to apoptotic pathways that may lead to increased apoptosis and reduced skeletal muscle mass. background: although sarcopenia's pathogenesis is multifactorial, with its major phenotypes, muscle mass and muscle strength, being highly heritable, its genetic underpinning is not well studied. objectives: summarize evidence for use of zebrafish as a model system to decode the sarcopenia's gwas findings. methods: several genome-wide association studies (gwas) of muscle-related traits were published recently, providing dozens of candidate genes, many of them with unknown function. therefore, animal models are required not only to identify causal mechanisms, but also to clarify the underlying biology and to translate this knowledge into new interventions. over the past several decades, small teleost fishes had emerged as a powerful system for modeling the genetics of human diseases. due to their amenability to rapid genetic intervention and the large number of conserved genetic and physiological features, small teleosts, such as zebrafish (d. rerio), are indispensable for skeletal muscle genomic studies. results: we summarize the evidence supporting the utility of small fish model for accelerating our understanding of human skeletal muscle in norm and disease. the following stable mutants (mostly knockouts) exist for the «monogenic muscle» diseases (human gene, fish mutant, disease): for duchenne and becker muscular dystrophy (md), sapje/dmd (homology of human dmd gene); for limb-girdle md, popdc s f (bves); for bethlem myopathy and ullrich congenital md, col a ama (col a ); for nemaline myopathy, froto c (myo b), and tmod trg (tmod ); for merosin deficient congenital md, lama cl /cl ; candyfloss/lama (lama ); for limb-girdle md, bvesicl /icl (popdc ), heltg (ttn), and «foie gras» (trappc ); for native american myopathy, stac mi (stac ), as well as fish homologues of the acvr , cacnb , cavin , cms, dag , fhl , flnc, vcp and other human genes. these models provide evidence of muscle-related gene's conservancy and similarity of skeletal muscle morphology and physiological phenotypes. we will outline challenges in interpreting zebrafish mutant phenotypes and translating them to human disease. conclusion: we conclude with recommendations of future directions to leverage. centenarians exhibit extreme longevity and a compression of morbidity. we showed previously that centenarians display a unique genetic signature, in terms of mrna and mirna profile, which is similar to that found in young people and different from that found in octogenarians. centenarian offspring seem to inherit centenarians' compression of morbidity, as measured by lower rates of age-related pathologies such as hypertension, diabetes, strokes, and heart attacks. we therefore hypothesized that they will also display a lower incidence of frailty. in this study, we aimed to ascertain whether centenarian offspring are endowed which such "genetic footprint" and a lower incidence of frailty, when compared to their contemporaries. for this purpose, we collected plasma and peripheral blood mononuclear cells from septuagenarians, , age-matched centenarian offspring (but not sons or daughters of the centenarians included in this study) and centenarians. mirna expression and mrna profiles were performed by the genechip mirna . array (affimetrix) and genechip clariom s human array (affimetrix), respectively. frailty phenotype was determined by meeting three or more of the following criteria: unintentional weight loss, low grip strength, exhaustion, slow gait speed, and low physical activity. we found that mirna and mrna expression patterns in centenarians are similar to centenarian offspring and different to non-centenarian offspring (p< . ). importantly, we found a lower incidence of frailty among centenarians' offspring (p< . ), when compared to their contemporaries. taken together, our results indicate that centenarian offspring resemble centenarian characteristics and that they enjoy significantly less frailty than their less fortunate contemporaries that are not sons or daughters of centenarians. this lower incidence of frailty may be a key feature to achieve extraordinary ageing. background: hypoglycemic episodes increase in older patients and their consequences are more significant. objectives: the aim of this prospective observational study is to explore unknown hypoglycemic episodes diagnosed by continuous glucose monitoring in older type diabetic patients and to describe the link between the occurrence of hypoglycemia and glycosylated hemoglobin (hba c) level. methods: we included patients with type diabetes aged years or over hospitalized during consecutive months in a geriatric acute care unit in tours university hospital in france. demographic characteristics, type of diabetic treatment, mini mental state examination, hba c levels, albumin and creatinin level were recorded. continuous glucose monitoring (cgm) was used to detect hypoglycemia for a maximum of days, and capillary blood glucose measurements (cbgm) were also performed to times a day. patients with at least one blood glucose measure lower than mg/dl were compared with others for demographic, clinical and biological parameters. results: seventeen patients experienced hypoglycemia. these groups did not differ in demographic characteristics and in diabetic drug class. among these patients, had an episode of severe hypoglycemia (< mg/dl) and patients had nocturnal episodes, more often between and am. twelve patients had unrecognized hypoglycemia by cbgm. the average duration of hypoglycemic episodes was . hours. there was no difference in the hba c levels between the two groups (mean . %, p= . ). conclusion: the prevalence of hypoglycemia is underestimated in the oldest diabetic population receiving hypoglycemic drugs. measurements of cbgm and hba c level in the target may overlook nocturnal and prolonged hypoglycemic episodes. our study showed the benefit of cgm in older diabetic patients in order to detect unknown hypoglycemia. more prospective studies are needed to explore factors that predict hypoglycemia. catenacci, sophie le-gonidec, alizée dortignac, ophélie pereira, romain madeleine, jean-philippe pradère, philippe valet, cedric dray (umr inserm,universitéfédéral de toulouse -universitépaul sabatier toulouse iii, france) background: healthy lifespan does not increase proportionally compared to global lifespan leading to an increased number of disabled aged persons. to increase healthy lifespan, locomotion could be considered in the future as the main targetable outcome to fight against the frailty to dependency transition. the so-called sarcopenia, characterized as the loss of muscle mass and function, affects to % of the populations over . mechanistically, sarcopenia is associated with an imbalance between protein synthesis and degradation, an increase of muscle inflammatory processes, a reduction of mitochondria-driven metabolism and an exacerbated fibrosis. several therapeutic strategies have been proposed such as hormonal replacement but, regarding the adverse effects, these strategies have been abandoned. in this context, we hypothesize that, through a modified secretory profile, adipose tissue could play a crucial role in the muscle loss of function. we previously promoted an unbiased proteomic study and identified haptoglobin as an up-regulated cytokine overproduced by the adipose tissue during aging. objectives: in this context, our project proposes to better understand the role of adipocyte haptoglobin in age-related muscle weakness. methods: to do so, we used complementary in vitro and in vivo models of haptoglobin supplementation and strategies of adipocyte haptoglobin over-expression/deletion. impacts of such interventions have been monitored by measuring myogenesic processes as well as muscle aging. moreover, a human cohort in progress will help to constitute a new biobank by collecting blood, adipose and muscle from sarcopenic individuals in order to evaluate the role of hapatoglobin on sarcopenia (inspire cohort). results: the results obtained in vivo and in vitro suggest that haptoglobin treatments induced an age-dependent decrease in muscle mass. moreover, these protocols indicated a muscle-specific role of haptoglobin when we measured the fiber diameter. in addition, a direct effect of haptoglobin on differentiation alteration was also observed in in vitro human muscle cells. conclusion: these results suggest that haptoglobin induces effects according to the age, the muscle type and the dose on muscle physiology. thus, a better knowledge of adipocyte haptoglobin production could help to better apprehend the age-related muscular complications. background: sarcopenia contributes to loss of independence and is increases risk of mortality. mitochondrial dysfunction and loss of proteostasis are two interrelated hallmarks of aging with well-established roles in skeletal muscle function. mitochondrial dysfunction increases cellular oxidative stress and impairs atp-generating capacity. consequentially, oxidatively-damaged proteins accumulate; however, a dysfunctional mitochondrial reticulum cannot sufficiently provide energetic resources to repair the proteome. in skeletal muscle, this impaired proteostasis and mitochondrial dysfunction promote sarcopenia. thus, improving mitochondrial function by increasing endogenous antioxidants could attenuate age-related loss of muscle function. objectives: using a phytochemical nrf activator (nrf a), we sought to determine if upregulation of cytoprotective genes would improve mitochondrial function and gait, an integrative metric of musculoskeletal function. methods: we utilized dunkin-hartley (dh) guinea pigs that develop primary osteoarthritis and experiences age-related skeletal muscle dysfunction by months of age (~ % of their maximal predicted lifespan). we treated young ( mo) and older ( mo) dh guinea pigs for and months, respectively, daily with a nrf a. we assessed metrics of gait monthly to measure the effect of nrf a on agerelated musculoskeletal dysfunction. we evaluated the effect of nrf a on skeletal muscle protein turnover using the stableisotope deuterium oxide. we also assessed soleus mitochondrial function using high resolution respirometry. results: while nrf a did not affect gait in young guinea pigs, months of nrf a treatment maintained stride length (p= . ) in older male and stance width (p< . ) in older female guinea pigs compared to untreated controls. nrf a improved (p= . ) adp vmax in young females and old males compared to their respective controls. nrf a also increased uncoupled electron transport system capacity in both male and female guinea pigs of both ages (p< . ). nrf a augmented contractile protein synthesis in the soleus of old male and female guinea pigs (p= . ), but did not prevent the age-related declines in the gastrocnemius. conclusion: in summary, long-term nrf a treatment improved skeletal muscle mitochondrial function, increased contractile protein synthesis, and maintained aspects of gait. together, our findings provide evidence that targeting the transcription factor nrf mitigates the decline in musculoskeletal function in a model of osteoarthritis and sarcopenia, with concomitant improvements in mitochondrial function and protein turnover. . j a n n e k e v a n w i j n g a a r d e n , francina j dijk , miriam van dijk , lisette cpgm d e g r o o t , y v e s b o i r i e , , y v e t t e c l u i k i n g background: sarcopenia is a muscle disease rooted in adverse muscle changes that accumulate across the lifespan. multiple factors cause or worsen sarcopenia, with aging as the primary factor and malnutrition, inactivity and diseases as secondary factors. objectives: to design a nutritional strategy to manage sarcopenia. methods: our research program investigated ) specific nutrient deficiencies in sarcopenic older adults, ) muscle protein synthesis (mps) response in cells and rodent models, and ) effect of a specific nutrient combination (whey protein, leucine and vitamin d -actisyn(tm), present in the medical nutrition supplement fortifit(r), on mps in older adults. results: cross-sectional studies indicated a significantly lower intake of protein (- %) and vitamin d (- %) in sarcopenic versus healthy older adults (p< . ) [verlaan, clin nutr ], and higher prevalence of sarcopenia among those with lower blood levels of leucine, total essential amino acids ( the specific combination of whey protein, leucine and vitamin d (actisyn(tm)) provides the right environment for muscle building in sarcopenia, where these nutrients are often deficient. this combination acts through a proven anabolic mode of action with optimal nutrient bioavailability for the muscle to stimulate mps. fortifit and actisyn are trademarks of n.v. nutricia. background: age-related sarcopenia is a major responsible for premature death, poor quality of life and several adverse outcomes, which lead to higher health care costs. despite its recent incorporation as a muscle disease (icd- -cm m . ), early identification of this disease remains challenging. mostly, due to classification and diagnostic criteria, which are predominantly based on technically advanced assessment tools, which may not be available in all clinic settings. recently, a non-invasive technique to analyze variations in biological tissues considering the effect of physiological and biological properties on microwave signals is being studied for its potential to determine muscle mass, with possible applications in the early diagnosis of this disease. objectives: therefore, the principal objective of this study is to preliminarily test the potential of this technique as a new tool for early diagnosis of age-related sarcopenia in a clinical setting. methods: muscle surface area are going to be assessed by abdominal computational tomography (ct) on the third lumbar spine vertebra (l ) and bioimpedance measurements among men and women, aged >= years in the maastricht university medical center, the netherlands. participants will also be subjected to measurements done with the device under test (dut) (the proposed technique) in the same location. the data collected from the three different measurements are analyzed looking for correlation. laboratory experiments made from synthetic materials emulating human tissues and from ex-vivo porcine tissues are used for optimization and interpretation of the clinical measurements. results: up-tonow, the campaign has just started and there is no enough data to give a preliminary result. initial laboratory experiments prove that the thickness of the fat and muscle tissues is correlated to the system response. conclusion: this prospective device will estimate the muscle mass locally using microwave electromagnetic principles. the results of this study can contribute to reveal the potential of this approach as a tissueanalysis tool for early diagnosis and management of age-related sarcopenia. the results might also provide useful evidence to consider in a future planned prospective cohort study, which aims to examine the impact of dietary biomarkers and genetic factors on the incidence of age-related sarcopenia in older adults. background: sarcopenia has become a serious problem in this aging society. at present diagnosis of sarcopenia consist of physical performance and muscle quantity. dexa has been widely applied to examine muscle quantity in clinical but it's radioactive, inconvenient and unaffordable in remote area. as a result, there are more studies in ultrasound in replace of dexa. objectives: based on others researches csa might be a suitable parameter to evaluate the muscle quantity. we develop a cheaper ultrasonic imaging system to evaluate the cross-sectional area (csa) of rectus femoris (rf)muscle. methods: we use a cmos image sensor combing with digital signal processor to detect the displacement of single element ultrasonic transducer. therefore, we combine us a-mode signal with displacement into b-mode image. by circling region of interest (roi), we can obtain the csa of rf muscle. then, we use siemens s evaluating the csa in the same region to testify the reliability. results: we recruited young college students undergoing the experiment. the result shows that the correlation coefficient is up to . . conclusion: in conclusion, our device can successfully evaluate the csa of rf muscle. moreover, our system using single element ultrasonic transducer is much cheaper than linear transducer in practice .it can be affordable in remote village or somewhere lacking in medical resource. a case-control study. camille nicolay , sandra higuet , sandra de breucker (( ) geriatric department, hôpital erasme, brussels, belgium; ( ) geriatric department, hôpital isppc-charleroi, charleroi, belgium) background: ten percents of belgian population are considered to be informal caregivers. little is known about their frailty status and their physical health. objectives: we compared the frailty status, the clinical and psychosocial status of old caregivers with controls (> ). we analyzed the association of frailty status according to fried's criteria and rockwood frailty index (fi) with the characteristics of caregivers and controls in multiple regression analysis. methods: eighty six caregivers and gender and agematched controls were included. frailty was assessed by the frailty phenotype (fried) and the -deficit frailty index (fi). social data, sf- health survey, basic and instrumental adl, geriatric depression scale, mini nutritional assessment, mini-cog, cumulative illness rating scale-geriatric, usual gait speed, handgrip strength, and burden scale (zarit) were collected. results: the prevalence of frailty was similar in caregivers and controls with the fi (p= . ) but higher with the fried's criteria (p= . ). compared with the control group, caregiving was associated with a lower mental quality of life (p< . ), a higher risk of depression (p< . ), a higher consumption of antidepressant (p= . ), a lower nutritional status (p= . ), a more frequent help from health care providers (p= . ), and more problems to maintain physical contacts with a social network (p= . ). in multiple regression, the fried's criteria adjusted for age, gender, marital status and incomes were associated with the age, the grip strength, the physical quality of life, the gait speed and the nutritional status (r = . -p< . ), while fi was associated with the risk of depression, the use of antidepressants, the physical quality of life, the cognitive status and basal & instrumental adl (r = . -p < . ) in caregivers. conclusion: the prevalence of frailty is similar in caregivers and controls when using fi, but higher in caregivers with fried's criteria. compared with controls, caregiving is associated with poorer health and psychological issues. while fried's criteria focus on physical frailty, the fi is more related with geriatric syndromes like depression, cognitive disorders, loss of autonomy, and quality of life. this study could help researchers to choose between frailty scales before starting a study about older caregivers. background: nursing home (nh) residents are often undernourished and physically inactive contributing to sarcopenia and frailty. mobility is identified by older nh residents as being key to their quality of life and well-being. the combination of protein supplementation and physical exercise has been shown to be most effective to maintain and increase muscle mass. objectives: the older persons exercise and nutrition (open) study aimed to investigate the effects of sit-to-stand exercises (sts) integrated into daily care combined with a protein-rich oral nutritional supplement (ons), on physical function, nutritional status, body composition, healthrelated quality of life and resource use. methods: residents in eight nh were randomized by nh units into an intervention group (ig) or a control group (cg) (n= /group). the ig was offered a combination of sts (four times/day) and ons ( bottles/day providing kcal and g protein) for weeks. the participants resided in nh units (dementia and somatic care), were >= years and able to rise from a seated position. the seconds chair stand test ( scst) was the primary outcome. secondary outcomes were balance, walking speed, dependence in adl, nutritional status and body composition, health-related quality of life and resource use. data was analyzed using descriptive and inferential statistics including regression models. results: altogether residents ( ± years, % females) completed the study. no improvement in the physical function assessments was observed in the ig, whereas body weight increased significantly ( . ± . kg, p= . ) vs the cg. twenty-one (of ) participants with high adherence to the intervention, i.e. at least % compliance to the combined intervention, increased their fat free mass ( . kg ( . , . iqr), p= . vs cg. logistic regression analyses indicated that the odds ratio for maintained/improved scst was . (ci . , . , p= . ) among the participants with high adherence compared to the cg. waly dioh , cendrine tourette , carole margalef , amy chen , rené lafont , , pierre dilda , stanislas veillet , samuel agus (( ) biophytis, sorbonne université -bc , paris, france; ( background: sarcopenia is a geriatric condition characterized by loss of muscle mass and functions and can contribute to risks of falls, fractures and hospitalization. sara-obs is a multicenter, observational trial designed to better characterize age-related sarcopenia in a community dwelling population at risk of mobility disability. this is part of a clinical program that strives to provide more understanding of the target population in order to further develop a potential sarcopenia medical intervention. sara-obs study rationale, design and main baseline characteristics are presented. objectives: the objective is to characterize sarcopenia and sarcopenic obesity in older adults through evaluation of their physical performance and body composition. changes in baseline characteristics after a -month period will be assessed and used for development of a phase interventional study on the efficacy and safety of an investigational drug, bio . methods: participant recruitment was based on age (>= years), sppb score =< and body mass based on the fnih criteria. physical functions were assessed by two walking tests ( m walk test and the -minute walk test), the sppb, the handgrip strength test and the stair climb power test. patient reported outcomes were also assessed with the sf- and the sarqol questionnaires. results: subjects were included in this study and the main screen failures were sppb scores and body mass criteria. baseline characteristics indicated that the average bmi was high, ~ % of the participants were women and that the alm/bmi in men was lower than the fnih threshold ( . vs . ) but was similar in women ( . vs . ). m gait speed was . m/s, the mean total sppb score was . with the gait speed component of < . m/s and the chair stand sub-score of . . conclusion: this population has a similar m gait speed as the populations in life and sprint-t studies at baseline. however, the sppb total score and the chair stand sub-score correspond more closely with the sprint-t study. addressing the loss of physical function and preventing mobility disability is still an unmet need of older adults. sara-obs included a population representative of a suitable target for subsequent interventional studies aimed to fulfill this need. yen-lung chen, hui-hua chiang (department of biomedical engineering, national yang-ming university, taipei, taiwan) background: in whole world, the elderly formally entered the aging society , and the patients with sarcopenia were highrisk groups in the fall. more than % of the elderly suffered moderate injuries due to falls. the sarcopenia as defined by the eu's sarcopenia working group was refers to progressive reduction in muscle mass and decreased muscle function. objectives: it is expected to provide diagnostic tools and techniques for the rapid determination of sarcopenia and muscle strength. at the same time, it will also be developed toward portable devices to facilitate the diagnosis of the aging of muscle function in the elderly at home to take care of the health and well-being of the elderly. methods: at present, the clinical measurement part is assisted by the radiation department of the veterans general hospital to collect and measure the subjects. clinical testing methods are mainly for older people over years of age. the walking speed test is firstly performed on the method. if it is normal, then the grip strength test is performed. if the grip strength is too small, the femoral rectus femoris muscle volume test should be performed. generally, dual energy is used. dual-energy x-ray absorptiometry (dxa) is used for testing. if the walking speed is too slow, the dxa test should be performed directly. the test value is less than . (kg/m ) in woman and less than . (kg/m )in man. that is, it is determined as a sarcopenia patient. since dxa has a small amount of free radiation, high cost, and a large space occupation, we expect to obtain a wide range of data through ultrasonic scans. back-end development algorithms are calculated to determine if there is sarcopenia and how severe it is. results: at present, the rectus femoris muscle volume obtained by using ultrasound has a highly linear relationship with the appendicular muscle mass measured by dxa (r = . ,p< . ), and has the ability to distinguish whether it is sarcopenia. conclusion: the use of muscle volume of rectus femoris can improve the accuracy of sarcopenia prediction. in the near future, this plan will be used to develop automated ultrasonic scanners. background: although sarcopenia has multifactorial causes, the decline in physical activity has been considered a very important aspect for its development. since the promotion of higher levels of physical activity can attenuate the progression of sarcopenia, it is possible that the participation in a programmed training increases the spontaneous physical activity of the participants. objectives: to investigate if the participation of sarcopenic older women in a resistance training program and supplementation with fish oil leads to changes in the level of spontaneous physical activity (sedentary time and number of steps). methods: randomized, double-blind, placebo-controlled clinical trial. thirty-two older women, aged >= years, participated in the study. all participants were classified as sarcopenic based on the criteria of the european consensus on sarcopenia (ewgsop). the participants were divided into two experimental groups: ( ) exercise group + placebo (ep) and ( ) exercise group + fish oil (efo). both groups underwent a resistance exercise program over weeks, consisting of three weekly supervised sessions. all volunteers were instructed to take two capsules of food supplement at each main meal, lunch and dinner ( g/day). the ep group used capsules composed of sunflower oil as placebo, and the efo group fish oil capsules, (epa mg and dha mg). measurements of the level of spontaneous physical activity were made before and after the intervention by using the actipal® physical activity monitor (glasgow, uk), for a period of seven consecutive days, during which the volunteers were instructed to maintain their normal routine. the volume of the quadriceps muscle in the pre and post intervention periods was calculated from the images obtained by magnetic resonance imaging. for statistical analysis, a linear regression model with mixed effects was used to compare longitudinal data on mean intra-group differences between groups and moments. for all analyzes, a significance level of . was adopted. results: both groups showed an increase in muscle volume after the intervention ( . cm ( . %) and . cm ( . %), respectively). regarding the level of spontaneous physical activity, both groups had a similar sedentary time and number of steps, at both times (average . h and , steps in the pre-intervention period and . h and , steps in the postintervention period for the ep group, and . hrs and , steps in the pre-period and . h and , steps in the postintervention period in the eop group). conclusion: although sarcopenic older women supplemented with fish oil showed a higher increase in muscle volume, the level of spontaneous physical activity remained unchanged both in the pre and post intervention periods and between groups, indicating that the increase in muscle volume was not associated with significant changes in the level of spontaneous physical activity. background: regardless of improvements in surgical and anesthetic practices, older surgical patients often experience postoperative complications. the purpose of this study was to investigate the association between physical frailty and cognitive function using a validated upper-extremity function (uef) test with in-hospital outcomes in aging adults undergoing abdominal surgery. objectives: to recognize frailty and cognitive function as a risk factor for in-hospital adverse outcomes. methods: we administered pre-operative uef tests, within -hours after admission, among patients aged years and older undergoing emergent/urgent abdominal surgery. the uef involved two tests; -and -sec of respectively fast and consistent elbow flexion, while angular velocity was measured via two wearable motion sensors applied to the wrist and upper-arm of the dominant arm. uef physical score was calculated, based on slowness, weakness, flexibility, and exhaustion (range: resilient= -frail= ). uef cognitive score was assessed based on motor function variability within a dual-task performance that involved uef motor task and a cognitive task of counting backwards by threes (range: cognitive normal= -cognitive impairment= ). adverse outcomes included: length of stay, complications, and death during their hospital stay. a logistic regression model was used to assess the association between uef physical and cognitive scores (independent variables) and in-hospital outcomes (dependent variable). results: a total of participants (mean age . ± . years) completed the preoperative uef assessment. thirty-six participants with an average age of . ± . years experienced at least one adverse outcome while in the hospital. while age independently predicted in-hospital outcomes with receiver operating characteristic area under the curve (roc-auc) of %, this prediction improved by adding either the uef physical or the cognitive score. the physical score predicted in-hospital outcomes with a roc-auc of %, and the cognitive scores predicted in-hospital outcomes with a roc-auc of %. conclusion: the proportion of emergency surgical procedures increases with age, and population trends indicate that this demand will increase significantly. results from the current study showed that sensor-based measures of physical and cognitive function can provide an objective tool for predicting adverse outcomes, with potential applications for other surgical procedures. risk stratification can help to establish targeted management strategies to improve the healthcare system and patient-centered outcomes. background: while sensor-based daily physical activity (dpa) gait performance has been demonstrated to be an effective measure of physical frailty, it is not clear how repeatable the dpa gait parameters are between different days of measurement, especially across frailty groups. objectives: to evaluate the test-retest reliability (repeatability) of dpa gait performance parameters (stride time, variability, and irregularity) and quantitative measures (number of steps and walking duration) between two separate days of assessment among older adults. methods: dpa was acquired for -hours from older adults (age>= years) using a tri-axial accelerometer motion-sensor attached to the trunk. purposeful continuous walking bouts (>= s) without long pauses (> . s) were identified from acceleration data and used to extract gait performance parameters, including stride time, power spectral density (psd) slope (representing the variability of walking cycles), dominant frequency of walking, and gait irregularity (sample entropy, representing predictability of walking cycles). to assess repeatability, intraclass correlation coefficient (icc) was calculated using two-way mixed effects f-test models for day- vs. day- as the independent random effect. repeatability tests were performed once for all participants and once within each frailty group (non-frail and pre-frail/frail). results: data from older adults, non-frail (age: . ± . years) and pre-frail/frail (age: . ± . years) were analyzed. within all participants with purposeful walking bouts on both the days, gait performance parameters of stride-time and gait variability parameters (slope and dominant frequency of walking) showed excellent test-retest reliability values (icc>= %) while quantitative parameters, including number of steps and walking duration showed poor test-retest reliability results (icc< %). among gait performance parameters (stride time, dominant walking frequency and sample entropy), we observed higher repeatability among the pre-frail/frail group with icc> % compared to icc< % for non-frail individuals. conclusion: from our study, it is evident that gait performance parameters including average step-and stride-time and frequency-domain gait variability parameters provided higher test-retest reliability compared to quantitative measures. further, gait performance parameters showed higher repeatability among pre-frail/frail volunteers between the two days compared to non-frail volunteers, which may be attributed to a lack of functional capacity among frail individuals for performing more intense and more variable physical tasks. background: while evaluation methods for skeletal muscle characteristics which are necessary to know the pathogenesis of sarcopenia are being considered, ultrasonography is attracting attention as a method simultaneously evaluate quantitative and qualitative evaluation of skeletal muscle. although we have found many, the statements that examined the relation between muscle thickness, echo intensity, physical function, and sarcopenia by quadriceps muscle ultrasonography in the previous report, there are few reports for the lower leg muscles. objectives: we conducted a study to examine whether the lower leg muscle ultrasonography is useful for evaluating sarcopenia index and muscle quality (muscle strength per unit muscle mass) evaluation in comparison with the quadriceps ultrasonography. methods: the participants were patients over years old ( males, females). the muscle thickness of the quadriceps muscle, tibialis anterior muscle, gastrocnemius muscle, soleus, and echo intensity were measured by ultrasonography, and the relationship between lower extremity muscle mass, muscle strength, physical function, and muscle quality was examined. results: the muscle thickness of quadriceps muscle, tibialis anterior muscle, soleus muscle was related to lower extremity muscle mass, grip strength, leg muscle strength, and only quadriceps muscle was related to gait speed. the echo intensity of the quadriceps, tibialis anterior, gastrocnemius was related to, grip strength, leg muscle strength, and only the tibialis anterior muscle was related to gait speed. the muscle thickness and the echo intensity of tibialis anterior muscle and soleus muscle are highly correlated with the quadriceps. the echo intensity of the tibialis anterior muscle, as well as that of the quadriceps muscle, showed a high correlation with the muscle quality of lower extremity. conclusion: concerning the assessment of sarcopenia using ultrasonography, muscle thickness and echo intensity evaluation by tibialis anterior muscle showed the same utility as them by the quadriceps muscle, and echo intensity of the tibialis anterior muscle can be a marker of muscle quality. lucena germano , cristiano dos santos gomes , juliana fernandes de sousa barbosa , , raysa freitas , , alvaro campos c. maciel , ricardo oliveira guerra ( ( background: phase angle (pha) is emerging as a measure of great clinical relevance provided through bioimpedance assessment and its related to health adverse outcomes such as osteoporosis and sarcopenia. on the other hand, poor physical performance as gait speed and grip strength in elderly is associated with poor health conditions. we hypothesized it is plausible that those two measures might be related and can be used as a tool in clinical practice. objectives: to investigate the relationship between pha and physical performance measures in community-dwelling older adults from brazil. methods: this cross-sectional study enrolled older adults of both sexes who had a comprehensive health evaluation including physical performance tests (gait speed and handgrip strength) and electrical bioimpedance screening. linear regression models were used to estimate the associations between pha and physical performance measures. results: the mean age of . ± . and . ± . for men and women respectively. hand grip strength (n: , ; p-value < , ) and gait speed (n: , ; p-value < , ) were independently correlated with pha. conclusion: pha could help to easily identify elderly on the onset of present heath adverse outcome and guide specific interventions by clinicians. shosuke satake , , kaori kinoshita , yasumoto matsui , background: in japan, we have a simple yes/no questionnaire to assess multiple functions in daily living for older adults; the kihon checklist (kcl). in the questionnaire, questions to assess mobile functions are included. objectives: we examined whether the -item questions in the physical domain of the kcl (kcl-phys) could be a surrogate of validated measurements of physical functions. methods: subjects were independent and ambulatory seniors aged years or older who had been consulted in our frailty clinic. all of them received grip strength test, dual energy x-ray absorptiometry, physical performance tests, cognitive examination, and the kcl questionnaire. among them, we excluded subjects with missing data, and with moderate cognitive impairments. we examined the relationships between scores of the kcl-phys and usual gait speed, short physical performance battery (sppb), and timed up and go (tug) with the spearman's rank correlation. the score of the kclphys were counted when the subject meets any criteria with each question as previously reported. also, we evaluated the cutoff point of the kcl-phys equivalent to slow gait speed (< . m/s), low sppb score (sppb < ), and slow tug (tug >= sec) with the receiver operating characteristic (roc) curve analysis. results: the mean values of age, body mass index, and prevalence of sarcopenia were . years old (women . %), . (kg/m ), and . (%), which were no differences between sexes. on the other hand, physical functions of gait speed, sppb, and tug were all worse in women than in men. relationships between the scores of the kcl-phys and usual gait speed, sppb, and tug were moderate with the coefficients of - . , - . , and . , respectively (p< . for all). the area under the roc curve of the kcl-phys score equivalent to slow gait speed, low sppb score, and slow tug were . , . , and . , respectively. the cutoffs were thought to be the best at points of the kcl-phys to identify low physical functions based on the youden index. conclusion: physical domain of the kcl could be a surrogate of assessments of physical functions in older people. yuji hirano , izumi kondo , tetuya nemoto , naoki itoh , hidenori arai (( ) national center for geriatrics and gerontology, japan; ( ) nihon fukushi university, japan) background: we have developed a new type of grip strength measurement that addresses the time axis in evaluating physical function. it can measure the dynamic force, response in gripping performance, and maximum grip strength. the "kihon checklist" (kcl) is used to screening the frail elderly, based on the japanese long-term care insurance system. however, the relationship between the gripping performance and kcl has not been well investigated. objectives: the purpose of this study was to introduce a novel automatic reading method for dynamic force parameters in gripping performance and to evaluate their relationship with the kcl. methods: the subjects comprised patients ( men, women, average age . ± . years) who visited the integrated healthy aging clinic (locomo-frail outpatient clinic in japanese) of our hospital. the four indices of grip force response measured were: reaction start time (rst), time constant (tc), maximum value of force (mvf), and force rising slope (frs). we examined the relationship between these four indices and seven categories of the kcl; activities of daily living (adl), physical functions and fall, nutrition state, oral functions, outdoor activities, cognitive functions and mood, using spearman's correlation coefficient. results: in the female right hand, the mvf was only significantly correlated with adl and overall scores; whereas, in the female left hand, the mvf and the frs were significantly correlated with many items (adl, physical functions and fall, nutrition state, outdoor activities, and cognitive functions). the time-dependent items (rst and tc) were significantly correlated with outdoor activities in the female left hand and significantly correlated with adl and oral functions in the male left hand. however, in the right hand, the time-dependent items were not correlated with any of items in kcl in both sexes. conclusion: our newly developed grip strength measurement system could automatically calculate not only the maximum grip strength but also the time response of the grip force. moreover, their relationship with kcl was clearly indicated. the relationship between detailed grip strength response indicators and kcl items differed between men and women, and the left hand was correlated with more items than the right hand. ranyah almardawi, rao gullapalli, michael terrin (university of maryland school of maryland, baltimore, usa) background: rotator cuff (rc) tear and shoulder pain are both highly prevalent in older populations. routine medical screening for shoulder dysfunction is uncommon for community-dwelling older adults. the disabilities of the arm, shoulder and hand (dash) survey estimates self-reported dysfunction of both upper limbs in a composite score. dash offers a quick method to identify older adults with potential dysfunction in either shoulder, which otherwise may go unrecognized during routine medical visits. objectives: . to determine if dash, american shoulder and elbow surgeons (ases) and simple shoulder test (sst) surveys are related to one another in older adults. . to assess dash, ases and sst score relationships to the sf- physical functioning (pf) subcomponent score, shoulder forward flexion range of motion (ff-rom) and shoulder abduction range of motion (abd-rom) in older adults. methods: cross-sectional study: twenty-three community-dwelling-older-adult volunteers [mean age, . ± . years; range, to years; female, %] with no history of rc surgery and no history of shoulder injury or shoulder physical therapy in the prior months completed shoulder magnetic resonance imaging (mri) and dash, sf- , charlson co-morbidity index (cci), katz activities of daily living (adls) and lawton instrumental adls (iadls) surveys. for the shoulder ipsilateral to mri, participants completed ases, sst, visual analog scale for pain (vas) surveys; and shoulder ff-rom and abd-rom. descriptive statistics and spearman rank order correlation (rho) were performed. results: frequencies: rc tear (supraspinatus tendon) on mri: . %; shoulder pain >= on vas: . %; no limitation (score= ) on katz adls: . %; no limitation (score= ) on lawton iadls: . %. means: cci, . ± . ; dash, . ± . ; ases, . ± . ; sst . ± . ; . ± . ; . ± . ; . ± . . range of correlation among dash-ases-sst surveys: (|rho|= . - . , p< . ). range of correlation for dash-ases-sst with sf- pf(|rho|= . - . , p< . ), p< . ), abd-rom (|rho|= . - . , p< . ). conclusion: dash, ases and sst correlate well, and all three surveys show a consistent relationship with sf- physical functioning, ff-rom and abd-rom. next steps would be to evaluate the feasibility of dash to identify older adults with shoulder dysfunction during routine medical visits. background: physical performance is closely associated with chronic diseases and dysfunction of numerous organ systems. old persons with chronic renal failure have shown the apparent decline in physical performance, especially in the end-stage. however, it is unclear whether the subclinical kidney dysfunction is associated with skeletal muscle function deficit in the elderly population. objectives: the aim of this study is to determine the association between renal function and skeletal muscle function deficit in old persons without nephropathy. methods: eight hundred fifty-four korean elderlies (female, . %) aged to years were included in the cross-sectional analysis. of the participants, elderlies (female . %) were available for the -year follow-up test session. all participants were interviewed face-to-face and received measures of anthropometry, body composition and serum biomarkers of metabolic diseases. estimated glomerular filtration rate (egfr) was calculated using the chronic kidney disease epidemiology collaboration (ckd-epi) equation based on serum creatinine concentration. skeletal muscle function deficit was defined as a combination of weakness and slowness based on the handgrip strength to body mass index ratio (hs/bmi, men < . , women < . ) and converted timed up-and-go to walking speed (tugspeed < . m/s). results: the subjects with <= egfr < ml/min/ . m showed significantly lower physical performance for muscular strength and functional mobility than those with <= egfr < and egfr > ml/min/ . m , respectively (all for p < . ). logistic regression analysis indicated the significant association between egfr and skeletal muscle function status even after adjustment for potential confounders (p for trend < . ). moreover, the prospective observational analysis by ancova showed the significant effects of enhancement in hs/bmi [f( , ) = . , p = . ] and tugspeed [f( , ) = . , p < . ] on the improvement in egfr during -year followup. conclusion: taken together, skeletal muscle function status is associated with even moderately reduced egfr in an older population. these results suggest that maintenance of physical and functional fitness may be a contributory factor for preserving renal function in elderly persons. rn, brazil) background: sarc-f is a brief and useful test to identify older people at risk of sarcopenia-associated adverse outcomes. previous studies with older populations have suggested that it may be useful to screen those with severe sarcopenia. its ability to screen sarcopenia among low-income brazilian older adults is still unknown and its association with sarcopenia diagnostic criteria may be useful to understand its utility among this population. objectives: this study aims to evaluate the validity of sarc-f in screening low muscle strength and low physical performance among a low-income sample of older adults. methods: in a cross-sectional study, community-dwelling older-adults (>= years old; men and women) from santa cruz (northeast brazil) answered the sarc-f questionnaire and were classified as sarcopenic (>= ) and non-sarcopenic (< ) according to sarc-f scores. they were also evaluated in relation to the sarcopenia criteria of muscle strength (handgrip strength) and physical performance (sppb). the cutoff of < kg for women and < kg for men were used to classify those with low muscle strength. a sppb score of <= was used to classify low physical performance. a chi-square test was used to assess the association between the sarc-f and the objective parameters of sarcopenia. sensitivity and specificity of the sarc-f according to the objective functional parameters were also assessed. results: the sample was composed by % of women, with mean age of . (± . ) years old. according to sarc-f, . % of the sample was sarcopenic. low muscle mass and low physical performance were identified in . % and . % of the sample respectively. sarcopenia was significantly associated to low muscle mass (p< . ) and low physical performance (p< . ). the sensitivity of sarc-f in identifying those with low muscle mass was of % and specificity of %. for low physical performance, sensitivity and specificity were of % and % respectively. conclusion: sarc-f has a moderate ability to identify the sarcopenia criteria of low muscle mass and low physical function among older adults from a low-income setting. since it is a simple measure, it can be advantageous for low-income and rural communities. background: menopause marks a critical transition towards older adulthood for women and studies suggest that it is associated to several sarcopenia parameters, such as muscle mass and physical functioning. understanding how the menopausal transition associates to sarcopenia diagnostic criteria may help to direct screening tests for middle-aged populations and to identify earlier those at higher risk of sarcopenia. objectives: to evaluate the association between menopausal status and sarcopenia diagnostic criteria (muscle strength, muscle quantity and physical performance). methods: in a cross-sectional study, communitydwelling women from northeast brazil ( - yearsold) were evaluated in relation to menopausal status using the stages of reproductive aging workshop classification (premenopausal, perimenopausal or postmenopausal) , and in relation to sarcopenia diagnostic criteria according to european working group on sarcopenia in older people (ewgsop ): muscle strength (grip strength -handheld dynamometer), muscle quantity (appendicular muscle mass adjusted for height through bioelectrical impedance) and physical performance (gait speed). association between menopausal status and sarcopenia criteria was evaluated with multiple linear regression models adjusted for covariates (current age, education, family income, walking, bmi, reproductive history). results: among the participants, . % were classified as premenopausal, . % as perimenopausal, and . % as postmenopausal. menopausal status was significantly associated to grip strength, since premenopausal women were significantly stronger than perimenopausal or postmenopausal women, even in the fully adjusted analyses (b= . ; % ci= . : . ). muscle quantity and gait speed were not significant according to menopausal status. conclusion: perimenopausal and postmenopausal status are associated with less muscle strength among middle-aged women. muscle weakness may be the first sarcopenia parameter that is affected by women's aging and should be tracked among middle-aged to women for early identification of sarcopenia risk.. background: we speculate maintaining good postural stability is the key to good adl in elderly patients. this is a preliminary study to evaluate which factor relates to good postural stability. objectives: we evaluated patients ( males and females) over years old. the average age was . years old ranging to . methods: we measured index of postural stability(ips) using gravicoder gw- manufactured by anima. the ips was adovocated by mochizuki in . it was defined following this equation; ips=log[(area of stability limit + area of postural sway)/area of postural sway). larger ips means better postural stability. the average ips in each age was already known. ips was calculated automatically through gravicoda. we devided these patients into two groups by the results of ips. group a with the patients whose ips was larger, group b with the patients whose ips was smaller than the average in their age. we compared the following items between the two groups. nutrition(albumin, calcium, magnesium, ferritin, vitamin b ,b , , -d , zinc in blood test) , bone status(bone density, % of yam), spinopelvic parameters (pelvic incidence(pi), lumbar lordosis(ll), pelvic tilt(pt) using whole spine x-ray photograph. results: ten patients were classified into group a and patients were into group b. the average age was . ± . years old in group a and . ± . in group b. in group a , ll and pt were respectively . , . . in group b, . , . . ll and pt were significantly different between the two groups. pi minus ll is an important indicator to determine the spino-pelvic balance. it is known that pi-ll< means good spino-pelvic balance. in group a, pi minus ll was . ± . . in group b, it was . ± . . according to nutrition and bone status, albumin was significantly higher in group b. conclusion: our results showed spino-pelvic alignment related to the postural stability. this suggests good spino-pelvic alignment is likely the key to good postural stability. background: physical performance is of main relevance for quality of life and independence in the community. identification of deterioration of physical performance helps to start early interventions to stay independently in old age. objectives: to determine physical performance of communitydwelling older adults above years by using a comprehensive geriatric assessment to find most sensitive tests for functional decline. methods: older community-dwelling adults aged +. analysis of baseline and (t ) and months (t ) of followup data of hand grip strength (hgs), stair climb power test (scpt), timed up and go test (tug), short physical performance battery (sppb), m gait speed ( mgs), -time chair rise test ( tcr), minute walking test ( mwt) and frailty categories according to fried. results are shown in mean (± sd) in total numbers and percentage. results: participants ( , y.± , ) were included, ( %) female. overall physical performance was on high level, above geriatric cut-offs for physical disabilities at baseline: (hgs female: , (± , ) (- , (± , )%) followed by scpt (- , (± , )%). all tests showed a decline except tcr (+ , (± , )%). conclusion: physically active, communitydwelling older people show a high level of functional performance, far from geriatric cut-offs indicating physical disabilities. nevertheless, after two years a clinically relevant reduction of strength in upper (handgrip) and lower extremities (stair climb) was detected. these data may be relevant for the identification of older individuals who may benefit from early intervention exercise programs to keep them physically independent as long as possible. tcr showed divergent results and could be of special interest for continuous measurements to identify gradual decreases in functional performance. background: sarcopenia is characterized by loss of skeletal muscle mass and strength and it is a frequent finding in oncology, being associated with reduced quality of life, impairment in the response to antineoplastic therapy and increased toxicity, especially in older patients. objectives: the aim of the present study was to evaluate the association between low muscle mass (lmm) assessed by computed tomography (ct) analysis and sarcopenia considering the revised european consensus published by the european working group on sarcopenia in older people (ewgsop ) with the variables of the comprehensive geriatric assessment (cga) in older oncological patients. methods: for this purpose, patients ( . % female; mean age of . ± . years) followed at the oncogeriatric outpatient clinic of a university hospital were enrolled. clinical data were obtained from electronic medical records and the skeletal muscle mass evaluation was performed using ct (in the height of the third lumbar vertebra). for lmm and sarcopenia classification, specific cutoff points were adopted. cga variables were compared between lmm and normal skeletal muscle mass (nsmm) and between sarcopenic and non-sarcopenic individuals. groups were compared by the independent t test (r core team®, p< . ). results: the most frequent tumors were breast, intestine, stomach and lung, at different stages of the disease. the prevalence of lmm was . % and the prevalence of sarcopenia was %. of all cga variables evaluated, hand grip strength ( , ± , ) and katz scale ( , ± , ) were associated with lmm and sarcopenia. conclusion: the results highlight the importance of early geriatric clinical assessment of older cancer patients, considering the association of cga variables with low muscle mass and most important, to sarcopenia, for the possible reversal of functional and nutritional impairments and for the indication or appropriate planning of cancer therapy. lygia paccini lustosa , patricia parreira batista , jéssica rodrigues de almeida , andré gustavo pereira de andrade , aimée de araújo cabral pelizari , stephanie aguiar , leani de souza máximo pereira (( ) physical therapy department -universidade federal de minas gerais, ufmg, eeffto, belo horizonte, mg, brazil; ( ) sports department -universidade federal de minas gerais, ufmg, eeffto, belo horizonte, mg, brazil) background: functional tests in the older person reflect the integrity of the interrelationship between muscle mass and function, vascular, endocrine and neurological aspects of central and peripheral command. the reduction in functionality, muscle mass and strength associated with advancing age is related to the increase of circulating proinflammatory cytokines in plasma, which in turn predisposes the individual to negative repercussions, such as the development of chronic diseases, falls and disability. they can identify changes in the intrinsic capacity of the older people. objectives: to compare older women who reported being active or sedentary regarding functional capacity and plasma indices of inflammatory mediators. methods: participated community older women ( years or older), recruited for convenience. those unable to walk were excluded; acute musculoskeletal diseases; lower limb fractures in the last year; neurological diseases and sequelae; history of cancer in the last five years and cognitive impairment (mental state mini-exam). all responded to clinical and demographic information, performed the short physical performance battery (sppb), timed up and go (tug) and plasma tests of stnfr and il- (elisa method). correlation analysis by spearman test. % significance level. approval by the research ethics committee/ ufmg (caae: . . . ). results: older women participated, with a mean age of . ± . y; number of comorbidities . ± . and medications in use of . ± . . mean of body mass index were . ± . kg/m . there was a significant negative relationship between the sppb test and stnfr (rho= . ; p= . ) and a significant positive relationship between tug and stnfr (rho= . ; p= . ). other relationships were not significant (p> . ). conclusion: older women with better functional capacity presented lower plasma dosage of stnfr . the results suggest influence between these variables -functional capacity, mobility and inflammatory process -and no causal factor can be attributed. in these case, longitudinal studies are needed to verify functional performance vulnerability factors and their causal relationship with circulating inflammatory mediators in plasma. however, these results point to the importance of evaluating these variables in daily clinical practice. patricia parreira batista , stephanie aguiar , andré gustavo pereira de andrade , jéssica rodrigues de almeida , leani de souza máximo pereira , lygia paccini lustosa (( ) physical therapy department -universidade federal de minas gerais, ufmg, eeffto, belo horizonte, mg, brazil; ( ) sports department -universidade federal de minas gerais, ufmg, eeffto, belo horizonte, mg, brazil) background: perceptions of health and well-being in the older people are identified as subjective aspects by the international classification of functioning (icf), with direct and indirect interference with overall performance, activities of daily living, social relationships and independence. subjective well-being is associated with the form of coping adopted with a health condition, adaptability and resilience. positive and negative physiological repercussions on functionality and interaction with the family and social network may be consequences of inadequate adaptation and perception of subjective well-being. objectives: to explore the relationship between subjective well-being, functionality and plasma indices of inflammatory mediators in community older wowen. methods: participated community older women ( years or older), recruited for convenience. those unable to walk were excluded; acute musculoskeletal diseases; lower limb fractures in the last year; neurological diseases and sequelae; history of cancer in the last five years and cognitive changes (mini-mental state examination). all answered about clinical and demographic data and information about subjective well-being. they performed tests of functional capacity (short physical performance battery -sppb) and mobility (timed up and go -tug). plasma dosages of stnfr and il- were by elisa method. correlation analysis by spearman test. significance level of %. approval by the research ethics committee/ ufmg (caae: . . . ). results: elderly women participated, with a mean age of . ± . years; number of comorbidities . ± . , final sppb score . ± . , tug of . ± . seconds; body mass index of . ± . kg/m . there was a significant positive relationship between subjective well-being and sppb (rho= . ; p= . ) and tug (rho= . ; p= . ). other associations were not significant (p> . ). conclusion: the results showed a significant association of subjective well-being with functional capacity in the older women. however, this condition was not associated with inflammatory markers, suggesting the need for further studies. on the other hand, it can be thought that the identification of personal strategies and perception of health and well-being act as barriers and/ or facilitators in a functional rehabilitation process, indicating the need for a multidisciplinary approach. background: the united states census bureau projects a rise in the population aged and over from . million in to . million by . the projected rise in the elderly population represents an accompanying increase in geriatric syndromes. frailty is a common geriatric syndrome defined as a clinically recognizable state of increased vulnerability to adverse outcomes related to a decline in physiologic reserve. this decline in reserve places the individual at increased risk for poor health outcomes including falls, disability, hospitalization, institutionalization and mortality. various effective interventions for frailty are established in the literature. the body of knowledge on the role of technology in reducing frailty is less abundant. objectives: to summarize available evidence on frailty and technology use for community dwelling older adults. methods: a comprehensive search of computerized databases was conducted in the following databases published between - : cinahl, pubmed, and academic search complete. the prisma search strategy was utilized for this review. articles were included if they met the following criteria: ) focused on community dwelling adults aged and over; ) peer-reviewed; ) published in the english language; ) featured randomized controlled trials (rcts), cohort studies or qualitative research; and ) included an operationalized definition for frailty. results: the database searches yielded a total of articles. duplicates were removed. results were excluded based on title and abstract. relevant articles were retrieved for full text examination. articles were excluded based on inclusion/exclusion criteria. references of included articles were hand searched for relevant works. four additional relevant articles were identified. the final analysis included articles. conclusion: current research focuses on assessment and diagnosis as opposed to intervention studies. methodological weaknesses limit generalizability and validity of findings. few studies utilize frailty as an outcome measure thus, limiting available research directly related to frailty. emerging technologies represent potentially effective, flexible and integrative solutions for frailty assessment, monitoring and intervention in the home environment. more research is needed on the potential for technological tools as interventions for frailty in community dwelling elderly specifically, for the purpose of detection and prevention of pre-frailty. a study protocol. inae c. gadotti , raquel aparicio ugarriza , , fernanda civitella , jorge g. ruiz , , edgar ramos vieira ( ( ) background: there are several studies on the association of balance and gait impairments with frailty and falls in older adults. however, little is known about the associations between postural alterations, frailty and falls in older adults in general and among older veterans. also, inter-relations among postural alterations, balance, strength, gait impairments, falls and frailty in older adults are not well known. objectives: the objective of this study is to evaluate if postural alterations, gait and balance impairments are associated with falls and frailty in older veterans. methods: sixty veterans, years old or older, will participate on a voluntary basis. one-hour long assessments will be completed at baseline, , and months. participants will fill out a questionnaire including information on demographics (age, sex, height, and weight), health conditions, falls (history, characteristics, and fear of falls), mobility impairments, physical activity level, medication history, medication changes and adherence, and health care utilization. frailty status will be assessed based on fried's frailty phenotype. the following physical health variables will be assessed: sagittal head and neck posture using photogrammetry, spinal curvatures using flexicurve, deep neck flexors activation by performing the craniocervical flexion test with a pressure biofeedback, grip strength using a dynamometer, usual and fast gait analysis using a gaitrite, balance using a force plate, and lower limb functional strength based on chair stands in s. differences among the variables by frailty status and falls history will be assessed using manovas. results: the results will be presented at conferences and published in scientific journals. conclusion: the results of this study may inform interventions to reduce frailty and falls in older veterans and possible among non-veterans as well. background: the number of deaths caused by pneumonia is increasing. the guidelines for pneumonia recommend optimal application of antibiotics based on a pathogenoriented strategy. despite wide distribution of these guidelines, pneumonia demonstrates high mortality in aged people. thus, for developing the next strategy for pneumonia management in aged people, new targets are required. with aging, the loss of skeletal muscle mass and strength occurs, which is named sarcopenia. the sarcopenia phenotype is associated with malnutrition. little is known about relationship between muscles and pneumonia, however, we reported that aspiration pneumonia induced respiratory muscle atrophy. impaired swallowing and/or cough functions often induce pneumonia in aged people. the swallowing muscle weakness is associated with impaired swallowing function. the strong respiratory muscles generate effective cough, which clears the airways and prevents pneumonia. objectives: to investigate presently unknown relationships between onset or recurrence of pneumonia in aged people and; respiratory muscle strength; swallowing muscle strength; and malnutrition. methods: a cross-sectional cohort study consisted of patients aged -year-old and older admitted to the hospital by pneumonia, and controls. the respiratory muscle strength was measured by a hand-held multi-functional spirometer with a pressure sensing transducer. the swallowing muscle strength was evaluated by measuring tongue pressure. a bioelectrical impedance analysis evaluated muscle and body fat masses. malnutrition was evaluated by serum albumin level and body fat mass. results: the respiratory (both the inspiratory and the expiratory) and the tongue muscle strengths, body trunk muscle mass, serum albumin level, and body fat mass divided by height were lower in aged pneumonia patients than in controls. body trunk muscles include the respiratory and swallowing muscles. the multivariate logistic regression model showed the low inspiratory and expiratory respiratory muscle strengths, the low body trunk muscle mass divided by height , and the low serum albumin level as risk factors for onset of pneumonia. for recurrence of pneumonia within months after the onset of pneumonia, low body fat mass divided by height was a risk factor. conclusion: above findings suggest that the respiratory muscles and malnutrition as new targets of the new management strategy for pneumonia in aged people. background: more than % of the people with hiv are older than fifty years. data about this population are still scarce and mainly focused on comorbidity instead of on physical function and frailty. hiv-funcfrail cohort is one of the four european cohorts of older hiv adults launched in . objectives: our main objective in this work was to know the factors associated to physical impairment. methods: longitudinal prospective cohort study. patients from the "hiv-funcfrail: multicenter spanish cohort to study frailty and physical function in years or older hiv-infected patients" were included. eleven centers participated. we recorded sociodemographic data, comorbidities and variables related to hiv infection. physical function was measured by gait speed and sppb and frailty according to frailty phenotype. other components of the comprehensive geriatric assessment such as depression and cognitive impairment were evaluated too. results: were included. median age was . ( . - . ). . % were women. at baseline median cd count was . ( . - . ). viral load was undetectable in . %. % of the patients had > comorbidities and . % had polypharmacy. . % of the patients were able to walk independently and % were completely independent for the activities of daily living. more than half were prefrail, . % prefrail and . % were robust according to frailty phenotype. . % of the patients had a sppb score < and . % had a gait speed < . m/sg. in the univariate analysis we found association between physical impairment defined as sppb score < with: diabetes, copd, osteoarthritis, comorbidities number, moca test < , gds-sf > and age. but in the multivariate analyses the factors associated were just: polypharmacy ) p= . ], gds-sf > [ . ( . - . ) p= . ]. conclusion: functional impairment was prevalent among older adults with hiv in their middleage. polypharmacy doubles the risk of functional impairment and depression increases the risk three-fold. therefore, polypharmacy, depression and physical function should be assessed in all the older adults with hiv in order to implement early prevention intervention to avoid physical impairment. sophie bastijns, anne-marie de cock, maurits vandewoude, stany perkisas (university of antwerp, antwerp, belgium) background: acute sarcopenia is defined as a decline in muscle mass and muscle function within days after hospitalization or acute illnesses, sufficiently to meet the sarcopenia criteria. muscle ultrasound is an objective and non-invasive technique that can measure muscle quantity and quality. muscle elastography can furthermore measure muscle stiffness, which is regarded as an important qualitative parameter. objectives: the primary aim of the study is to assess the effect of acute hospitalization on muscle stiffness. the secondary aim is to evaluate other influencing parameters. methods: this study is a prospective, observational study. patients admitted for at least days to one of the geriatrics departments of the zna antwerp hospitals are included. rectus femoris (rf) and vastus lateralis (vl) muscle stiffness are measured through elastography on day of admission, and then every days until discharge. results: preliminary results show significant differences between rf and vl values in men, but not in women. in rf, a non-significant downwards trend is seen for elastography between day and day . in vl, a non-significant downwards trend is seen in women, but also a non-significant upwards trend is seen in men between day and day . in rf, a non-significant trend of decreasing stiffness is seen with increasing age in men, but an increase is seen in women. a significant negative correlation is seen between elastography of rf and vl on day and hand grip strength on day . conclusion: this study seeks to gain insight in parameters affecting muscle stiffness and of the evolution of muscle stiffness after acute illness or hospitalization. a trend of decreasing muscle stiffness is seen after seven days of hospitalization and illness. this study showed no direct relation between age and muscle stiffness. a decrease in muscle stiffness results in higher hand grip strength and therefore better muscle performance. more data and longer follow-up periods are needed and are expected by march . ainhoa indurain , , jennifer linge , mikael petersson , thobias romu , fredrik uhlin , , anders fernström , mårten segelmark , , olof dahlqvist leinhard (( ) departments of nephrology and medical and health sciences, linköping university, linköping, sweden; ( ) departments of acute internal medicine and geriatrics and medical and health sciences, linköping university, linköping, sweden; ( ) background: sarcopenia is a prevalent condition in hemodialysis patients and it´s associated with poor quality of life, hospitalization and mortality. recent research using magnetic resonance imaging (mri) has demonstrated the importance of proper body size-adjustment in the assessment of muscle mass, and that the addition of muscle fat infiltration reflecting muscle quality, improves functional correlations and prediction of hospitalization in sarcopenia. it is not yet demonstrated if this new mri method, combining body sizeadjusted muscle volume and muscle fat infiltration, improves the evaluation of sarcopenia in hemodialysis patients. objectives: to investigate if adverse muscle composition, defined using mri, predicts survival and comorbidity in hemodialysis patients. methods: in , patients on hemodialysis were scanned using rapid whole body fat and water separated mri. following years, survival and comorbidity index (nci) were recorded using electronic health care records. thigh muscle fat infiltration (mfi) and fatfree muscle volume (ffmv) normalized with height was assessed using amra research (amra medical, linköping sweden). a z-score describing the deviation from expected ffmv/height was calculated using sex and bmi-matched virtual controls (ffmvvcg) and mfi adjusted (mfiadj) was calculated using the sex-specific population mean. for these calculations, normative data from subjects in uk biobank was used. to estimate a combined muscle score (musclecomb), mfiadj and ffmvvcg were projected on the linear regression line describing the normal population relationship between mfiadj and ffmvvcg in the uk biobank dataset. spearman rank correlation was estimated comparing mfiadj, ffmvvcg and musclecomb to nci. wilcoxon signed-rank test was used to estimate the association to survival. roc values and confidence interval were also calculated. results: musclecomb (combined muscle score) was significantly correlated to comorbidity (p< . ) and predicted survival (p< . ) while mfiadj (adjusted muscle fat infiltration) and ffmvvcg (deviation from an individual´s expected muscle volume) did not reach significant level on either test. the roc values for predicting survival were . ( . - . ) for ffmvvcg, . ( . - . ) for mfiadj, and . ( . - . ) for musclecomb. background: frailty is a risk factor for cardiovascular disease (cvd). as declines in bone metabolism and impaired inflammatory response are often associated with frailty, bone analytes and inflammation markers involved in these signaling pathways may act as biomarkers of frailty-related disease progression. objectives: this study sought to examine differences in systemic bone analyte and inflammation marker concentrations based on cvd risk profile and frailty status. methods: females with no prior cvd were stratified into low or high cvd risk groups based on their framingham risk scores. frailty was assessed using the fried phenotype of frailty. greedy matching with pre-frailty as the exposure variable was used to identify a set of closely matched pairs in both the low and high cvd risk groups for a total of females in a case-control design. factorial anova was used to compare differences in log transformed concentrations of bone and inflammation analytes based on frailty status, cvd risk, and their potential interaction. results: differences for il- ( . ± . vs. . ± . pg/ml, p= . ), leptin ( . ± . vs . ± . pg/ml, p= . ) and tnfα ( . ± . vs . ± . pg/ml, p= . ) systemic concentrations were found with high cvd risk status compared to low. no differences in bone or inflammation analyte concentration were found based on frailty status, nor were any interaction effects. conclusion: there was a difference in inflammatory marker concentrations based on cvd risk status indicating that higher cvd risk is associated with impaired inflammatory response in females. there was no difference in bone or inflammation analytes in the pre-frail group compared to their robust peers as these females may be too early in the progression of frailty to have these signs of impaired bone health and inflammation. ( ) pancreato-biliary cancer center, gangnam severance hospital, yonsei university college of medicine, seoul, korea) background: biliary tract cancer (btc) is a highly lethal disease, and improved prognostication methods should be sought. sarcopenia (low muscle mass), poor muscle quality (low muscle attenuation) and excess adiposity (subcutaneous and visceral) can be surrogate markers of sarcopenia and related frailty. however this hypothesis has not been demonstrated conclusively in btc patients. objectives: to evaluate associations of all four body composition measures, derived from clinically acquired ct at the time of initial diagnosis, with overall survival in advanced btc patients. methods: we measured skeletal muscle index (smi), mean muscle attenuation (ma), visceral adipose tissue index, and subcutaneous adipose tissue index via computed tomography at the level of the l vertebra. clinical data were extracted from patients' charts. results: a total of patients ( % males, median age [range - ]) were included in this study, % were metastatic and % were recurrent disease. during the follow-up duration (median of . months; range . month to months), patients ( %) died. sarcopenia, defined as low l smi (lower than cm /m for women and lower than cm /m for men) was noted in patients ( %), and patients ( %) had low muscle radiodensity. for adiposity, % and % of patients had low subcutaneous and visceral fat, respectively. when we combined this four factors and grouped the patients, no risk group (n = ) had the best overall survival (median . months, % ci, . - . ), while the patients who suffered all the risk factors (n= ) showed the poorest survival (median . months, % ci, - . ) which was statistically significant (log-rank test < . ). this classification was independent factor for survival in multi-variate analysis along with other clinical factors, carcinoembryonic antigen (cea), neutrophil-to-lymphocyte ratio, white blood count, platelet, and cholesterol (hr . , % ci . - . ). conclusion: sarcopenia, ma, and adiposity independently predict mortality in patients with btc and can be utilized as surrogate markers for prognosis. background: frailty is a clinical syndrome of reduced systemic physiological reserve that phenotypically overlaps with heart failure. nt-probnp is a cardiac-specific marker that increases with ventricular stress, whereas growth differentiation factor (gdf- ) is a non-tissue specific systemic marker that increases with inflammation, tissue injury and possibly inflammageing. objectives: this study aims to determine if combination of nt-probnp and gdf- organised in a x matrix can classify cardiac dysfunction with and without frailty, non-cardiac frailty, and non-frailty. methods: this is a cross-sectional analysis of a prospective cohort study (phase ), undiagnosed heart failure in older adults (ufo), that recruited community-living older adults aged >/= years in a ratio of : : for robust, pre-frail and frail status classified by the frail scale. participants without a history of heart failure and meeting the eligibility criteria were entered into the study. nt-probnp and gdf- levels were measured using the roche cobas elecsys platform. echocardiography and -minute walk distance ( mwd) were documented. informed consent was obtained from all participants. the study was approved by the local institutional review board. ) was ascertained by correlation with abnormal echocardiographic diastology represented most prominently by increased left atrial volume index (r= . , p= . x e- ). conclusion: a x dual biomarker approach utilising nt-probnp and gdf- may assist in subclassification of cardiac (diastolic) dysfunction and frailty. background: frailty was occurred frequently in elderly and known as higher risk of mild cognitive impairment (mci) and dementia than healthy elderly. hippocampus, parahippocampus and entorhinal cortex as memory system is considered one of the key regions of dementia especially alzheimer's disease. in addition, atrophy of these regions presumably related to higher risk of alzheimer's disease. on the other hand, it is poor understood about neural substrates of relationships frailty and higher incident rates of mci and dementia. objectives: the purpose of this study, therefore, to clarify differences of atrophy level of hippocampus, parahippocampus and entorhinal cortex and total gray matter between healthy, pre-frail and frail in elderly. methods: a total , elderly were measured brain structure with t-mri, and , were fulfilled inclusion criteria in this study. structural brain images were preprocessed and total hippocampal volume was estimated using freesurfer v . . and ubuntu . lts. we classified participants into three groups as healthy, pre-frail and frail characterized by , or and or more of the following domains respectively: low activity, slowness, weight loss, exhaustion and weakness. we compared total gray matter or hippocampal volume between healthy, pre-frail and frail in elderly with one way analysis of covariance (ancova) adjusted for sex, age, educational years, drinking and smoking habit, geriatric depression scale points and estimated total intracranial volume (etiv) and multiple comparison using bonferroni correction. results: the prevalence of pre-frail and frail was . % and . % respectively. hippocampus, parahippocampus and entorhinal cortex volume were significantly decreased in elderly with frail compared healthy and pre-frail (hippocampus: p= . and p= . ; parahippocampus: p= . and p< . ; entorhinal cortex: p= . and p= . respectively). in contrast, total gray matter volume was not significantly difference between three groups. conclusion: hippocampus, parahippocampus and entorhinal cortex were atrophied in elderly with frailty compared healthy or pre-frail elderly. it might be neural substrates of higher risk of dementia in elderly with frailty. rasekh kashkosh , irina gringauz , jonathan weissmann , gad segal , , michael swartzon , abraham adunsky , , dan justo , (( ) geriatrics division, sheba medical center, israel; ( ) biomedical engineering department, israel; ( background: low alanine aminotransferase (alt) blood levels prior to rehabilitation are associated with poor rehabilitation outcomes in terms of low mobility and function in older adults following hip fracture. objectives: we have hypothesized that low alt blood levels prior to rehabilitation are also associated with -year mortality in this population. methods: included were older adults (age >= years, median age years, . % women) admitted for rehabilitation following hip fracture. alt blood levels were documented between one and six months prior to rehabilitation. excluded were patients with alt blood levels over iu/l possibly consistent with liver injury. the study group included patients with low ( iu/l or lower) alt blood levels, and the control group included patients with high-normal ( - iu/l) alt blood levels. the main outcome was all-cause mortality one year following rehabilitation admission. results: the study group included ( . %) patients with low alt blood levels, and the control group included ( . %) patients with high-normal alt blood levels. overall, ( . %) patients died within one year following rehabilitation admission. compared with the control group, patients with low alt blood levels had significantly higher -year mortality rates ( . % vs. . %, or . , %ci . - . ). cox regression analysis showed that low alt blood levels prior to rehabilitation were associated with -year mortality (hr . , %ci . - . ) together with peripheral vascular disease (hr . , %ci . - . ) -independent of age, gender, albumin serum levels, length of rehabilitation, and rehabilitation outcomes. conclusion: low alt blood levels prior to rehabilitation are associated with -year mortality in older adults following hip fracture. fawaz azizieh , dia shehab , khaled al jarallah , renu gupta , raj raghupathy (( ) gulf university for science & technology, mubarak al-abdullah area, kuwait; ( ) faculty of medicine, kuwait university, jabriya, kuwait) background: in addition to some well-characterized bone turnover markers, cytokines and adipokines have also been suggested to be linked to osteoporosis seen in menopause. however, there is much controversy on the possible association between these markers and bone mineral density (bmd). objectives: this study was aimed at measuring circulatory levels of selected cytokines and adipokines in postmenopausal women with normal and low bmd. methods: the study population included post-menopausal women, of whom had normal bmd, had osteopenia and had osteoporosis. circulatory levels of selected pro-resorptive (tnf-a, il- b, il- , il- , il- , il- ), anti-resorptive (ifng, il- , il- , il- , tgf-b) and five adipokine markers (adiponectin, adipsin, lipocalin- /ngal, pai- and resistin) were measured using the multiplex system and read on the magpix elisa platform. further, two bone turnover markers (p np, ctx) as well as estradiol levels were assayed from the same samples. results: while circulatory levels of cytokines were comparable between groups, women with low bmd had statistically significantly higher median circulatory levels of adipokines as compared to those with normal bmd. further, while levels of ctx were not different between the two groups; p np, p np/ctx ratio and estradiol levels were significantly lower in women with low bmd. levels of adiponectin, p np, p np/ctx ratio and estradiol correlated significantly with bmd of the hip and spine. conclusion: while the associations between the studied markers and bmd may be complex and multivariate, our data provide insights into the possible use of circulatory levels of cytokines, adipokines and bone turnover markers on the pathogenesis of postmenopausal osteoporosis. background: with the application of diffusion tensor imaging (dti), a few studies have found that some white matter (wm) structures were closely related to impaired gait speed. however, the evidence is still sparse and the wm structural association with overall lower-body physical function, which can be evaluated by short-physical performance battery (sppb), has never been investigated among older adults. objectives: the aim of this study is to explore the associations between wm structures (evaluated by dti parameters) and sppb scores among older adults. methods: data of participants ( ± years old), who were recruited in the multidomain alzheimer's preventive trial (mapt) study and with no dementia at baseline level, were analysed in this study. based on the functional magnetic resonance imaging data, dti parameters of fractional anisotropy (fa), mean (md), axial (ad) and radial diffusivity (rd) were calculated in wm structures that were annotated by the john hopkins university white matter parcellation atlas. linear regression was used to analyse the association between sppb score and each dti parameter while controlling for age, gender, body mass index, physical activity level, total intracranial volume, cardiovascular risk and time interval between the dti and sppb measurement. results: three dti parameters (the md and rd of left corticospinal tract, and the md of right cerebral peduncle) were associated with the sppb score at a p-value < . . conclusion: the findings indicate that wm structures of corticospinal tract and cerebral peduncle might be related to overall lower-body physical function of older adults. further studies on the changes of these wm structures with physical function alterations during ageing will be more informative. background: ct-derived skeletal muscle index and skeletal muscle density (smd) have been independently associated with mortality in older adults. although smd is a commonly used measure of myosteatosis on ct images, more novel muscle texture (i.e., radiomic) features may provide an alternative measure of muscle quality, independent of smd. there have been no prior studies on the association of ct-derived muscle texture features and mortality. objectives: to examine the association of skeletal muscle texture features with all-cause mortality in older adults from the national lung screening trial (nlst). methods: the relationship between ct-derived skeletal muscle texture and all-cause mortality over years was determined in , participants ( % women, age range - years, mean age . ) in the nlst. using ct images at the level of t vertebra, paraspinous muscle was automatically segmented using machine learning algorithm, and muscle texture features determined using pyradiomics. second order (and higher) texture features were grouped into categories: gray level dependence matrix (gldm), gray level co-occurence matrix (glcm), gray level run length matrix (glrlm), gray level size zone matrix (glszm), and neighbouring gray tone difference matrix (ngtdm). muscle texture features often indicate greater or lower heterogeneity/complexity of an image. associations between standardized muscle texture variables and all-cause mortality were determined using cox proportional hazards models, adjusted for age, sex, race, body mass index, pack years of smoking, presence of type diabetes, chronic lung disease, cardiovascular disease, cancer at enrollment, and smd. multiple comparisons were accounted for using false discovery rate testing. results: after a mean . ± . years of follow-up, ( . %) participants died. in fully adjusted models, the following muscle texture features were associated with mortality: gldm-dependenceentropy (hazzard ratio (hr) per standard deviation (sd)= . , p< . ), gldm-dependencenonuniformity (hr per sd= . , p= . ), gldmsmalldependencelowgraylevelemphasis (hr per sd= . , p< . ), glrlm-graylevelnonuniformity (hr per sd= . , p< . ), glszm-small area low gray level emphasis (hr per sd= . , p= . ), ngtdm-coarseness (hr per sd= . , p= . ), ngtdm-strength (hr per sd= . , p= . ). each of these associations were in the direction that suggested greater heterogeneity of the image was associated with increased mortality. conclusion: in a large multicenter cohort of community-dwelling older adults, ct-derived muscle texture features indicating greater heterogeneity were associated with mortality, independent of common covariates including skeletal muscle density. background: growth differentiation factor (gdf ) has been related with disease progression, mitochondrial dysfunction, and mortality. elevated gdf- level was recently reported to be associated with poorer physical performance in very healthy community-dwelling adults. however, until now, the relationship of serum gdf- level with sarcopenia in community-dwelling older adults has not been well characterized. objectives: this study aimed to investigate the association between serum gdf- levels and sarcopenia in community-dwelling older adults. methods: we analyzed participants (mean age, . ± . years; . % men) who underwent measurement of serum gdf- level and sarcopenia parameters, using their baseline data from the korean frailty and aging cohort study. participants with reduced kidney function, specifically an estimated glomerular filtration rate (egfr) from creatinine of < ml/min/ . m , were excluded. serum gdf- level was quantified with an enzyme-linked immunosorbent assay kit. appendicular skeletal muscle mass was measured using dual-energy x-ray absorptiometry. sarcopenia status was determined in accordance with the asian working group for sarcopenia (awgs) guidelines. results: according to the awgs algorithm, ( . %) of the participants in the whole study population were classified as having sarcopenia. gdf- concentration had significant negative correlations with appendicular lean mass (men, r = - . , p < . and women, r = - . , p = . ), grip strength (men, r = - . , p = . and women, r =- . , p = . ), and gait speed (men, r = - . , p = . and women, r = - . , p = . ). in the multivariate analysis adjusted for potential confounders, the highest gdf- quartile (>= pg/ml) was associated with a greater risk of sarcopenia (odds ratio [or] = . ; % confidence interval [ci], . - . ) than the lowest quartile (< pg/ml). these associations remained unchanged (or = . ; % ci, . - . ) after further adjustment for potential biomarkers (e.g., myostatin, dehydroepiandrosterone, and insulin-like growth factor- ). the or per unit increase in log-transformed gdf- level was . ( % ci, . - . ). conclusion: higher circulating gdf- levels were independently associated with a greater risk of sarcopenia in community-dwelling older adults. gdf- may be considerate a promising biomarker of sarcopenia. background: frailty has been recognized as an emerging public health problem in rapidly aging populations worldwide. use of biomarkers to identify frailty has been suggested for early frailty screening. among multiple risk factors of frailty, inadequate nutrition such as inadequate intake of protein and vitamin d has been shown to be associated with increased risk of frailty. therefore, nutritional biomarkers could be useful for early screening of frailty. objectives: to review the evidence of potential biomarkers, especially nutritional biomarkers for early screening of frailty in community-dwelling older adults. methods: a literature search was conducted using pubmed and scopus databases. studies evaluating blood biomarkers and frailty in community-dwelling older adults from to were included. information on the definition of frailty, study design, characteristics of the study populations, and the associations between biomarkers and frailty was summarized. results: in total, studies were identified in which observational studies were published since . majority of studies used physical frailty. other definitions such as multidimensional, social and frailty were also used. biomarkers were identified. cross-sectional and longitudinal studies consistently showed that low level of vitamin d was associated with frailty. emerging scientific evidence suggested that abnormal level of albumin, low levels of high-density lipoprotein (hdl), beta-hydroxy beta-methylbutyrate (hmb), vitamin b (measured by pyridoxal- -phosphate), carotenoids, or a-tocopherol (vitamin e), and high level of dp-ucmgp (marker of vitamin k) could have the potential for frailty screening. besides nutritional biomarkers, the evidence showed that inflammatory markers such as c-reactive protein (crp), interleukin- (il- ), and fibrinogen, and endocrine-related markers such as hemoglobin, dehydroepiandrosterone sulfate (dheas), and hemoglobin a c could be useful for screening frailty. additionally, there is evidence suggesting that some oxidative or immune-related markers were associated with frailty. conclusion: vitamin d could be a useful nutritional biomarker for early frailty screening in the community setting. other nutritional biomarkers, inflammatory markers and endocrine-related markers could be associated with frailty. further research is needed to validate and refine other potential biomarkers. jonathan quinlan , , , amritpal dhaliwal , , felicity williams , , matthew armstrong , , leigh breen , , , ahmed elsharkawy , , carolyn greig , , , janet lord , , ( ( ) background: end stage liver disease (esld) is associated with reduced muscle mass with a reported incidence of sarcopenia of - % (bhanji, ). loss of muscle mass in esld patients has a negative impact on clinical outcomes including mortality and recovery rates from liver transplantation (montano-loza, ) . previous research has investigated loss of muscle mass in esld via appendicular skeletal muscle mass and psoas muscle cross sectional area (csa) using dxa and magnetic resonance imaging (mri) respectively. however, the quadriceps muscle group has high functional significance and thus should be investigated in esld patients in whom function may be limited. ultrasound (us) offers a non-invasive, bedside imaging assessment of quadriceps muscle mass. however, esld may be associated with increased subcutaneous fat which can present an operational challenge for us and thus its application in esld patients requires validation. objectives: the aim of this research is to validate the accuracy of ultrasonographic measures of quadriceps muscle mass by comparison with the gold standard of mri. methods: parallel mri and us were collected from patients with an esld diagnosis and awaiting liver transplant ( patients, age ± yrs, bmi . ± . ). participants underwent us scanning of both left and right quadriceps followed directly by an mri. specifically, measures of vastus lateralis (vl) muscle thickness (mt) and quadriceps csa were obtained at % femur length during longitudinal and extended field of view us respectively. to enable direct comparison with quadriceps csa obtained during mri, an oil capsule was placed upon the leg to mark the exact location of us image collection. all procedures received research ethics committee approval and written informed consent from the participants. results: a significant (p< . , n= ) positive correlation was found between vl mt and quadriceps csa obtained via mri (r = . ). similarly, there was a significant positive correlation (p< . , n= ) between csa obtained via extended field of view us and mri (r = . ). bland-altman plots demonstrated a bias of - . ± . cm , with % limits of agreement of - . cm and . cm . conclusion: our data demonstrate that the assessment of quadriceps csa and vl mt via us may offer a suitable bedside alternative to mri in patients with esld. background: sarcopenia is defined as the gradual ageassociated loss of both muscle quantity and strength in older adults, and severe sarcopenia affects subject performance (such as reduced gait speed). it is a devastating condition, predicting an increase in mortality, falls, fractures and hospitalizations. current clinical criteria diagnose sarcopenia through dual x-ray absorptiometry (dxa) measures of muscle mass, a test that cannot be performed at the bedside and is rarely used to find this condition. point-of care ultrasound (pocus) is rapidly becoming a standard part of the physical exam, and has the potential to become a quick, noninvasive marker for both muscle mass and function. objectives: we examined the relationship between ultrasound measures of muscle mass (vastus medialis thickness, mt) and other measures of muscle quantity (appendicular skeletal mass, asm; mid-arm biceps circumference, mabc). we also examined the association between mt and measures of muscle strength (grip strength) and muscle performance (gait speed) in an older adult population. methods: older adults (age >= ; mean age . ± . years, women, men) were recruited sequentially from geriatric medicine clinics. each subject had appendicular skeletal muscle mass (asm, by bioimpedance assay), grip strength, mid-arm biceps circumference (mabc), gait speed, and an ultrasonic measure of muscle quantity (mt, vastus medialis muscle thickness) measured. our initial models contained age, sex, bmi, and mt as predictor variables, and our outcome variables were asm, grip strength, mabc and gait speed. results: in our final parsimonious models, mt showed a strong significant correlation with all measures of muscle mass, including asm(standardized ß= . ± . , r = . , p< . ) and mabc(standardized ß = . ± . , r = . , p= . ). with respect to measures of muscle quality, there was a strong significant correlation with grip strength (standardized ß = . ± . , r = . , p= . ) but not with subject performance (gait speed). conclusion: mt showed strong correlations with both measures of muscle mass (asm and mabc) and with muscle strength (grip strength). riki kosugi , yung-li hung , toshiharu natsume , shuichi machida (( ) faculty of health and sports science, juntendo university, inzai, chiba, japan; ( ) institute of health and sports & medicine, juntendo university, inzai, chiba, japan; ( ) coi project center, juntendo university, bunkyo-ku, tokyo, japan; ( ) graduate school of health and sports science, juntendo university, inzai, chiba, japan) background: loquat (eriobotrya japonica) leaves are commonly used in teas and folk medicines. recently, loquat leaf extract (lle) has been reported to promote muscle protein synthesis in vitro. additionally, resistance exercise has been shown to promote muscle protein synthesis in vivo. it is considered that lle and resistance exercise might have a synergistic effect on activating muscle protein synthesis. however, this has never been investigated. objectives: the purpose of the present study was to investigate whether lle enhances the muscle contraction-induced activation of muscle protein synthesis signaling in rats. methods: male wistar rats ( weeks old, n= - /group) were categorized into a control (con) group, an lle-administered (lle) group, an electrical muscle stimulation (ems) group , and an ems with lle (ems+lle) group. rats were administered lle ( . g/kg/ day) or distilled water once in a day by oral gavage for days. on the seventh day, h post-lle administration, the gastrocnemius muscle of the right legs of ems group and ems+lle group rats were stimulated by ems ( hz, v) through sets of isometric contractions ( s contraction, s rest) with min inter-set intervals. rats were then sacrificed and their gastrocnemius muscles were rapidly excised h post-ems. expression levels of muscle synthesis-related proteins [protein kinase b (akt), mammalian target of rapamycin (mtor), and ribosomal protein s kinase beta- (p s k)] were determined by western blotting. results: no significant differences were observed in body weight, water intake, and diet intake among the groups. akt phosphorylation at ser was found to be significantly increased in the ems+lle group compared to that in con group; mtor phosphorylation at ser did not show a significant difference. p s k phosphorylation at thr was found to be significantly increased in the ems group compared to that in con group, while the ems+lle group was observed to have significantly higher p s k phosphorylation at thr than the ems group. conclusion: our study suggests that lle enhances the muscle contraction-induced activation of p s k phosphorylation. background: metabolic aging has emerged as a new sedentarity related syndrome combining metabolic diseases and sarcopenia, a degenerative loss of skeletal muscle mass, quality, and strength associated with aging. it has been recently shown that kynurenic acid (ka), a key metabolite of tryptophan/ kynurenine pathway, improved glycemic control and lipid profile in rodents. objectives: to show that ka has a key role in metabolic aging, we have evaluated its effect on muscle function and mass in vitro and in vivo in muscle cell line and in a model of hindlimb immobilization in mouse. methods: in vitro in c c muscle cells we measured the ability of ka to inhibit myostatin gene expression (endogenous inhibitor of muscle growth), stimulate protein synthesis and enlarge muscle cell size. differentiated cells were exposed to ka for h for protein analysis, h for gene study and the days of differentiation for cell enlargement examination. in vivo, muscle mass (tibialis and soleus) was measured after a week-hindlimb immobilization in mice treated or not with ka ( mg/kg.day per os). results: in vitro, ka significantly and dose-dependently inhibited myostatin gene expression, stimulated protein synthesis and enlarged c c muscle cells. in mice, ka treatment significantly reduced tibialis and soleus muscle wasting induced by immobilization. conclusion: we demonstrated for the first time the positive impact of ka on muscle function and mass preservation offering a promising therapy for patients affected by metabolic aging, who do not currently benefit from relevant therapeutic solutions. Â n g e l a m a r i a p e r e i r a , , , a n a f r e i t a s , a n a p a c i f i c o , c a t a r i n a c o s t a , m a r g a r i d a a l m e i d a (( ) physiotherapy departement, escola superior de saúde egas moniz, portugal; ( ) centro de investigação interdisciplinar egas moniz, monte da caparica, portugal; ( )hospital garcia de orta, almada; portugal) background: as people age they are more likely to fall. although most fall-related injuries are minor, they can cause significant pain and discomfort, affect a person's confidence and lead to loss of independence. some falls can cause serious long-term health problems. one strategy to promote greater adherence and motivation to intervention in physical therapy is the use of virtual environment (ve) programs associated with a balance exercise programs as an effective method of preventing falls. objectives: the purpose of this study was to analyze the benefit of a virtual environment exercise program in non-institutionalized elderly at the end of six weeks. methods: in this randomized controlled trial non-institutionalized elderly were included. subjects, age . ± . yrs constituted the experimental group (eg); and , age, . ± . yrs constituted the control group (cg). the eg was submitted to weeks of a ve exercise program performed on a nintendo wii, and to a set of recreational activities. the cg only performed the activities. the instruments used in the present study to evaluate performance were tinetti's index, which evaluates the static balance and the gait to quantify the risk of fall, and the fullerton's functional fitness tests to assess physical parameters such as strength, aerobic endurance, flexibility and agility/ balance. results: at the end of the weeks of intervention in a virtual environment, significant improvements in upper limb strength, agility and static balance were observed. in the intragroup comparison, it was possible to verify improvements in all physical fitness battery tests. the values of functional fitness tests were significantly different (p<. ) between eg and cg groups for the following variables: -second chair stand . ± . vs. . ± . times; arm curl . ± . vs. . ± . times; -foot up-and-go . ± . vs. . ± . sec; two min. step . ± . vs. . ± . steps, respectively; as well as for the tinetti index. conclusion: this study, suggests that exercise in ve context applied to non-institutionalized elderly, promotes improvements in mobility, in lower limbs muscular strength, and may help to reduce the risk of falls by improving the static and dynamic balance. background: the small non-coding micrornas (mirs) are endogenous regulators of gene expression. they bind to complementary sequence on target messenger rna transcripts resulting in translational repression or target degradation. they are involved in the skeletal muscle response to training in animals and humans (kirby, ) . objectives: the aim of our study was to measure the effects of high intensity interval training (hiit) associated or not with l-citrulline on the expression of serum and muscle mirs in a group of men. methods: we selected men (mean age: . ± . years, men in the placebo group and in the l-citrulline group, gr/day) from a cohort of men and women submitted for weeks to hiit (buckinx, ) . we evaluated the expression of serum and muscle mirs before and after training. the quantification of mir expression was performed using the next generation sequencing (ngs) technique (exiqon). for statistical analysis, the measurements were normalized with the tmm method (trimmed mean of m-values). results: we identified mirs from serum and mirs from muscle above the detection limit (>= tpm, tags per million). after benjamini-hochberg correction, serum mirs from the l-citrulline group had a significantly different level of expression before and after training: - p, b - p, , a- p and - a- p (p < . , % fdr). no mir of the placebo group had a significantly altered expression. in muscle, our approach revealed mirs with a significantly different level of expression before and after training in the placebo group and in the l-citrulline group, of which were common to both groups. these mirs were different from those highlighted at the serum level. the most-expressed muscle mirs with the greatest difference in expression before and after training were - p, - p, - p, - p and b- p (p < . , % fdr). conclusion: with the ngs approach, we identified mirs differentially expressed before and after hiit. expression of circulating mirs appears to be influenced by l-citrulline. the next validation step will be to measure these specific mirs in the entire cohort to determine the clinical utility of these markers. background: recent interventional studies on frailty used multicomponent programs (physical exercise, cognitive stimulation, and nutritional supplementation) with some promising results. however, these emerging programs developed to counter the multidimensional concept of frailty still need methodological improvements to be completely effective. objectives: the objective of this innovative project is to develop personalized multicomponent interventions that could be easily used by frail older adults in order to reverse physical, cognitive and psychosocial symptoms associated with frailty. three original and specific action levers will be used to insure a better effectiveness: /to target a key population (hospitalized frail older adults who will be discharged to home), /to use a real multicomponent program (physical exercises simultaneously associated with cognitive and social components that mimic daily gestures), and /to encourage adherence through medical prescription. methods: one hundred and twenty frail older adults (>= ) will be recruited from the geriatrics unit of the university hospital of tours (france), and randomly assigned to one of the two study arms: the intervention group (ig), who will receive a medical prescription of an adapted multicomponent intervention, vs the control group (cg; no intervention). twelve-week programs will be adapted according to observed intrinsic capacities of the frail older adults. including exercises will be based on effective international physical programs, with original cognitive and social components added to the physical exercises. all participants will perform pre-and post-tests to compare their physical health (gait speed, balance, and strength), cognitive health (global cognition and executive functions), and psychosocial health (self-efficacy and quality of life) before and after the three-month program. results: a pilot study to this rct has already started in tours. the international conference on frailty and sarcopenia research would be the perfect opportunity to share preliminary results. the intervention will be considered as feasible if ig participants adhere to > % of the prescribed exercise and as effective if we observe significant improvements in all clinical outcomes for ig participants, compared to the cg. conclusion: final objective will be to disseminate to a large number of individuals the idea that several concrete ways exist to age well. amanika kumar, clarissa polen-de, gladys asiedu carrie langstraat, aminah jatoi (mayo clinic, rochester, minnesota, usa) background: frailty in patients with advanced stage ovarian cancer (oc) is common and associated with increased oncologic and surgical morbidity and mortality. prehabilitation is one option to reverse frailty in this subset of patients. objectives: our aim was to investigate potential barriers and facilitators of prehabilitation during neoadjuvant chemotherapy (nact) in oc patients. methods: we identified patients who underwent nact from - at a large volume single institution. patients underwent a semi-structured one-on-one phone interview. transcripts from interviews were read by independent reviewers to identify emerging themes related to patients' experience, functioning and exercise during chemotherapy. results: five primary themes emerged following analysis of the participants transcripts. participants were overall willing to participate in exercise during chemotherapy, with / patients stating they would walk or did walk at least minutes daily during treatment; this was linked to a strong motivation to improve surgical and survival outcomes. only / patients stated they were not interested in exercise during treatment. most notable, patients' motivations were tied closely to physician recommendation. patients prominently identified a shift in health as a priority following their ovarian cancer diagnosis, which subsequently lead to an increase in daily activities and exercise. surgery and improvement in mental well-being were strong motivators for patients to start or continue an exercise program. participants also identified barriers to exercise during treatment including a variety of treatment related and nontreatment related concerns, including neuropathy, nausea, pain, program availability, time and most significantly fatigue. despite this, most retrospectively thought they would have been willing to exercise with modifications. almost all participants voiced the importance of a supportive treatment community, including their medical care team, family, friends and the local community. conclusion: patients with advanced ovarian cancer demonstrated high motivation and willingness to exercise during chemotherapy when there was a perceived benefit to overall survival. prehabilitation may be a helpful to improve outcomes, but a prehabilitation strategy should be designed specifically for the patients with the most need and designed with barriers and motivators in mind. randomized control trial. kosuke fujita , , hiroki umegaki , aiko inoue , huang chi hsien , , hiroyuki shimada , masahumi kuzuya , (( ) institute of innovation for future society, nagoya university nagoya, japan; ( ) department of community healthcare and geriatrics, nagoya university graduate school of medicine nagoya, japan; ( ) department of preventive gerontology, center for gerontology and social science, national center for geriatrics and gerontology obu, japan) background: gait disorder in older adults could lead fatal consequence following falling or reducing physical activity, especially in individual with pre-clinical / clinical cognitive decline. effectiveness of exercise intervention for the gait characteristics has been examined in previous studies, however, evidence about differences between exercise modality such as aerobic training (at) and resistance training (rt) for the acute and long phase is unclear. objectives: the aim of the present study was to compare the effect of different exercise modality on the gait characteristics of older adults with preclinical cognitive decline. methods: individuals (mean age, . years) with self-reported cognitive decline were enrolled in randomized controlled trial. subjects assigned to at group (n = ), rt group (n = ) and at+rt group (n = ) underwent exercise intervention days a week for weeks. subjects assigned to control group (n = ) were provided information about healthy aging. gait characteristics were examined before, just after the intervention and after the weeks of follow-up period using an electronical walkway system. results: in the analyses about the change between pre and just after the intervention period, all of three exercise groups significantly improved gait velocity (at, p < . ; rt, p < . ; at+rt, p < . ), stride time (at, p < . ; rt, p = . ; at+rt, p < . ), cadence (at, p < . ; rt, p = . ; at+rt, p < . ), stride length (at, p < . ; rt, p = . ; at+rt, p < . ) and double support time (at, p < . ; rt, p < . ; at+rt, p < . ), and at+rt group improved significantly with cv of step width (p < . ). in the analyses about the change between pre and follow-up period, rt group only had improvements with gait velocity (p < . ), stride length (p = . ) and double support time (p = . ). conclusion: all exercise interventions could improve gait characteristics of older adults with pre-clinical cognitive decline. for the purpose of maintain improved gait characteristics for a long phase, rt is likely to be recommended. activity and a broader array of physical and psychological outcomes among nursing home residents. however, some limitation of this game should be acknowledged (e.g. too long, too bulky, exercises too simple). taking into account these weaknesses, we decided to develop and validate a new version of a giant exercising board game: the gamotion. objectives: to evaluate the impact of gamotion on physical capacity, motivation and quality of life among nursing home residents. methods: a one-month randomized controlled trial was performed in two comparable nursing homes. eleven participants ( . ± . years; men) meeting the inclusion criteria took part in the intervention in one nursing home, whereas participants ( ± . years; men) were assigned to the control group in the other institution. the gamotion required participants to perform strength, flexibility, balance and endurance activities. the assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the selfdetermination theory (ryan & deci, ) . physical capacity (i.e. quantitative evaluation of walking using locometrix; grip strength using jamar dynamometer; knee extensor isometric strength using microfet ; fall risk using tinetti test; dynamic balance using timed up and go test (tug) and physical abilities using sppb test), motivation (i.e. using behavioral regulation in exercise questionnaire- ) and quality of life (i.e. using eq- d questionnaire) were assessed at baseline and at the end of the intervention. a two-way repeatedmeasure analysis of covariance (ancova) was used to assess time*group (intervention vs. control group) effects. results: globally, during the intervention period, the experimental group displayed a greater improvement in symmetry of steps (p= . ), tinetti score (p< . ), tug (p= . ), sppb (p< . ), knee extensor isometric strength (p= . ), grip strength (p= . ), domains of the eq- d (i.e. mobility, self-care, usual activities : p< . ) and intrinsic motivation (p= . ) compared to the control group. conclusion: the effects of gamotion on physical capacity, motivation and quality of life of nursing home residents confirm the results obtained with the previous version of the giant exercising board game. in-hospital stay, even in short stays, is associated with functional impairment in older patients. objectives: the agecar plus study aims to evaluate the effectiveness of a program of physical exercise and health education to prevent the functional deterioration during the in-hospital stay. methods: randomized clinical trial. patients older than years admitted to the ace of the general university hospital gregorio marañón were included and randomized at admission in control group (cg) or intervention group (ig). exclusion criteria were baseline barthel ( days before admission) less than points, severe cognitive impairment or unable to walk. both groups received usual care, and patients in intervention group also performed simple supervised exercises (strengthening of lower limbs, walking, and inspiratory muscle training). in the preliminary analysis, we analyzed the effect of the intervention on changes in short physical performance battery (sppb) and alusti test, at admission and discharge, by t-test of repeated measures in the study periods. results: from may to february , patients were included: gc and ig. the cg and ig were homogeneous in sex (women . %), age ( . ± . vs. . ± . ), comorbidities (charlson: . ± . vs. . ± . ), cognitive impairment (pfeiffer: . ± . vs. . ± . ), fragility (fried >= : % p= . ), and functional-physical capacity (sppb: . ± vs . ± . ; alusti, . ± . vs . ± . ). p < . for all variables. a significant effect of the intervention was found, with a higher mean score in the alusti test in the ig (cg: . ± . vs . ± . ; f( , )= . ; p= . ), not finding such differences with the sppb ( . ± . vs . ± . ; f( , ) = . ; p= . ). conclusion: the preliminary analysis shows that the alusti test could be used as an evaluation test for functional capacity in hospitalized elderly patients. a physical exercise program during hospitalization in an acute unit improves the functional capacity assessed by the alusti test at discharge significantly. funding: instituto de la salud carlos iii (pi / ), ciberfes, fondo europeo de desarrollo regional (feder). the authors declare no conflicts of interest. a. sampaio , i. marques-aleixo , , j. carvalho (( ) ciafel -research center in physical activity, health and leisure, faculty of sport, university of porto, portugal; ( ) faculty of psychology, education and sports, lusófona university of porto, portugal) background: cognitive impairment is a highly prevalent, poorly managed, and disabling consequence of dementia. exercise training that improves physical fitness can represent a promising approach for managing cognitive impairment in persons with dementia. objectives: the aim of this crosssectional study investigated the association of physical fitness and balance with cognitive function. methods: sixty-four institutionalized older adults, aged . ± . years, with dementia, predominately female ( %) and with dementia due to alzheimer's disease ( . %). regression analyses were used to examine associations between physical fitness components (senior fitness test), balance (tinetti index) and cognitive function (mini-mental state examination). results: univariate regression indicates a significant association between the strength of the upper body (p= , ) and aerobic endurance (p= , ) with the cognitive function in older people with dementia. conclusion: these results suggest an association between the specific dimensions of physical fitness and cognitive function. consequently, multicomponent exercisebased therapeutic strategies aiming to improve physical fitness could be an important nonpharmacological strategy for dementia management. satoshi kurita, takehiko doi, kota tsutsumimoto, sho nakakubo, hideaki ishii, hiroyuki shimada (section for health promotion, department of preventive gerontology, center for gerontology and social science, national center for geriatrics and gerontology, aichi, japan) background: women had higher risk of cognitive impairment or dementia compared to men. although studies reported physical activity (pa) and/or cognitive activity (ca) had protective association with cognitive impairment among older adults, it is unknown whether the association is depended on sex or not. objectives: the purpose of the present study was to examine the sex differences in the association of pa and/or ca with cognitive impairment in community-dwelling older adults. methods: a community-based cohort survey was conducted in a total of participants (mean age . ± . years; . % female) who met the study criteria. time of moderate-to-vigorous intensity pa was measured using an accelerometer. ca was assessed by the frequency of engaging in activities using a ca scale including reading, doing crossword puzzles, and playing board games or cards. participants were categorized into four groups based on quartile (low) and to (high) values of pa and ca. cognitive impairment was defined by at least out of neuropsychological tests having a result at least . standard deviation below the reference threshold. results: in both sex, the prevalence of cognitive impairments showed significant differences among groups; that of low pa/low ca group, low pa/high ca group, high pa/low ca group, and high pa/high ca group were respectively . %, . %, . %, and . % for male (p < . ) and . %, . %, . %, and . % for female (p < . ). in binomial logistic regression models for male, all groups showed a low odds ratios of cognitive impairment compared to the low pa/low ca group (odds ratio = . to . , all p < . ), while for female, only high pa/high ca group had significant association with cognitive impairment (odds ratio = . , % confidence interval = . to . , p = . ). conclusion: in male, pa and ca are associated with cognitive impairment even in the case of low engagement in either pa or ca. in female, higher engaging in both activities are associated with cognitive impairment. female older adults may need to engage in more activities than male to acquire benefit on preventing cognitive impairment. ( interventions) were included in the systematic review and in the meta-analyses ( interventions). there was considerable heterogeneity in the number for interventions that detected significant increases in muscle mass ( / , %) and muscle strength ( / , %). of those muscle strength interventions / ( %), / ( %), / ( %) and / ( %) interventions reported a significant increase in handgrip strength, lower body muscle strength, upper body muscle strength and whole body muscle strength respectively. ret factors associated with the greatest gains in muscle mass and muscle strength were: use of combination of equipment, seven to eight exercises per session with three lower body exercises, a volume of three to four sets and to repetitions per exercise, a frequency of two-three days per week, intervention length of greater than six weeks, progressive intensity, intervention duration of - minutes, and in a supervised individually training structure. these results align with current guidelines provided by american, australian, japanese, british, canadian and japanese societies. conclusion: not all ret interventions are effective for improving muscle mass and strength, but our meta-analysis suggests that adhering to the current ret guidelines for older adults are likely to be most effective. duarte barros, andreia pizarro, arnaldina sampaio, joana carvalho (research center in physical activity, health and leisure, faculty of sports, university of porto, portugal) background: sedentary time (sed) and low physical activity (i.e. low levels of moderate-to-vigorous physical activity [mvpa] ) are different behaviours associated with negative health outcomes, but how synergetic combinations of these behaviours impact the risk of frailty are still unexplored. objectives: to examine the relationship between different combinations of sedentary time and mvpa in the risk of being frail. methods: a cross-sectional study including community dwelling elders ( . ± . years; . % female) accessed frailty through the phenotype of frailty. daily sed and mvpa were objectively measured using accelerometry. sed and mvpa were ranked by the median and then participants were categorized into one of four groups: lowsed+lowmvpa, l o w s e d + h i g h m v p a , h i g h s e d + l o w m v p a a n d highsed+highmvpa. results: overall, . % of the participants were frail. mvpa was associated with reduced odds of being frail (or . ic: . - . , p < . ). moreover, compared to the highsed+lowmvpa, the groups lowsed+highmvpa (or . ic: . - . , p = . ) and highsed+highmvpa (or . ic: . - , p < . ) were associated with reduced odds of being frail. conclusion: mvpa seems associated with reduced odds of being frail, irrespective of sedentary time. background: sarcopenia is central to frailty and the strongest evidence for reversal lies in the combination of resistance exercise and protein supplementation. unfortunately, uptake amongst older adults remains low, partly due to a lack of suitable exercise programs. delivery by health professionals alone will not achieve widespread participation. objectives: defrail aims to develop a novel exercise program (focused on resistance training), feasible for delivery to frail older adults in a group setting without the input of health professionals, and to examine its effect when combined with commercially-available protein-supplemented milk. methods: a multi-component exercise program was designed by expert consensus using a modified delphi process. participants were recruited from geriatric medicine clinics and primary care, with assessments at baseline, after eight weeks of regular activity and then after the eight-week intervention. the primary outcome measure was the change in the fried frailty criteria (ffc) during the intervention compared with the period of regular activity. secondary outcome measures included the timed up & go (tug) and -second sit-to-stand ( sts) tests. results: the first participants to complete the program ( females, males, mean age , range - ) had a median ffc score of (interquartile range (iqr) , ), i.e. frail, both at baseline and after the period of regular activity period, but had improved to (iqr , ), i.e. pre-frail, following the intervention. similarly, the median tug was . (iqr . , ) at baseline, increasing to . (iqr , . ) after the period of regular activity, improving to . (iqr . , . ) following the intervention. the median sts was (iqr , ) at baseline, (iqr , ) after the period of regular activity, improving to (iqr , ) following the intervention. conclusion: median frailty improved from frail to pre-frail for the first defrail participants. this program could allow increased community-based participation in resistance exercise for frail older adults. further work now includes completion of the intervention and analysis of data on a range of secondary outcome measures (assessments of cognition, mood, pain, body mass composition and biochemical markers of frailty). background: exercise interventions have been shown to improve functional status and quality of life of frail older people, and in some cases to reverse frailty status. it is important that such interventions are targeted to those people who would benefit the most. objectives: the objective of this pilot study was to assess the effectiveness of a physical activity intervention given to mildly frail older people, who were identified using electronic health records (ehr). methods: the electronic frailty index (efi) was used to identify mildly frail older people and offer them a physical activity intervention of their choice. the pilot study was offered in one area of luton (uk), with invitation letters sent by the participants gp. participants were tested before and after a -week programme of strength, balance and mobility, delivered in a weekly session lasting one hour. participants were assessed at baseline for motivation using the patient activation measure (pam), physical function using the short physical performance battery (sppb), and fear of falling using the falls efficacy scale international (fes-i). each test was carried out in a follow-up test after the programme had concluded. bootstrapped paired t-tests were used to assess the effect of the intervention. results: twenty-seven people aged . ± . years took part in the intervention. the pam scores improved from . % to . % ( . , % ci: . , . ), which is twice the minimal clinically important difference (mcid) of . for sppb, there was an improvement from . to . ( . , % ci: . , . ). the average increase was greater than the mcid for a substantial improvement of . . when fes-i was assessed, only three people ( %) had high concern about falling. there was no significant improvement in fes-i after the intervention (- . , % ci: - . , - . ). after the intervention, % of participants choose to pay for the continuation of the programme. conclusion: the findings of this study suggest that a targeted exercise programme including strength and balance training can significantly improve motivation and functional status among mildly frail older people identified using the efi, with the majority choosing to continue exercising. background: despite frailty has traditionally been examined from a physical standpoint, recent studies advocate for the existence of cognitive frailty ( ), and suggest that both physical and cognitive frailty are interrelated. thus, interventions should aim to prevent or attenuate the effects of frailty from a multidimensional perspective. objectives: to evaluate the effects of three different exercise programs on frailty among older adults living in long-term nursing homes (ltnh). methods: participants ( . % female) met the following criteria: aged years, scored on the barthel index, scored on mec test (an adapted version of mmse in spanish) and capacity to stand up and walk m independently. participants were randomly assigned to a progressive multicomponent group (mcg; n= ), a multicomponent dual-task group (dtg; n= ), or to a walking group (wg; n= ). the mcg underwent a -month moderate intensity strength and balance exercise program twice a week. the dtg performed simultaneous cognitive training (attention, inhibitory control, calculations and semantic memory) to the mc program. the wg walked up to minutes per day for days a week. frailty was measured though the following tests: fried frailty index (ffi), the tilburg frailty index (tfi) and the study of osteoporotic fractures (sof). results: the ffi revealed reductions in frailty in all groups, although only the mcg and the wg reached statistical significance (p< . ). as for the tfi and sof tests, no statically significant differences were found in any of the groups. however, there was a positive trend in tfi in the dtg (p= . ). no group-by-time interactions were found in any of the frailty tests used (p> . ). conclusion: our study showed no differences between interventions regarding frailty. however, the mcg and the wg showed significant reductions in phenotypic frailty, whereas the dtg showed a positive trend in the tfi, which takes into account physical, psychological and social domains. therefore, further studies should explore the effects of different exercise modalities on frailty from a broad perspective in older adults living in ltnhs. references: kelaiditi et al . j nutr health aging. ( ) : - . noirez , , iraj hashemi , deborah kopoin , pierrette g a u d r e a u , m a r c b é l a n g e r , g i l l e s g o u s p i l l o u , josé a morais , aubertin-leheudre ( ( ) background: aging leads to a loss of muscle strength and functional capacity. these phenomena can be slow down by daily exercise practice or resistance training intervention. objectives: the aim of this study was to investigate in elderly men muscle fiber size and type after resistance training. methods: among sedentary older men who completed a -week mixed power training program, were biopsied in the vastus lateralis before and after the program. cross sections were performed on these muscles, followed by triple immunohistochemical staining with antibodies directed against laminin, myosin heavy chain (myhc)- and myhc- a coupled with staining with secondary fluorescent antibodies. immunostaining analysis of laminin allowed us to determine fiber size and these of myhcs to determine fiber type. results: the size of the muscle fibers remained the same between before and after the mixed power training (p= . ).there was no significant difference in the percentage of expression of myhc- , a, x (p= . , p = . , p = . ) between before and after intervention. in addition, there was no difference in the size of fiber expressing myhc- between before and after the training (p = . ). however, significant increase in the sizes of fiber expressing myhc- a and myhc- x (respectively p = e- , p <. ) after the mixed power training was observed. conclusion: in elderly men, an increase of the size in fibers both expressing myhc- a and myhc- x in vastus lateralis muscle could explained the improvement on muscle mass observed previously (carvalho et al. acer ) . to confirm the mechanism explanation of this promising exercise modality, mitochondrial parameters should be also analyzed. background: muscle (in)activation related with sedentary behavior (sb) and physical (in)activity (pa) is a risk for sarcopenia in older adults. although age is not yet a risk factor for sarcopenia in adulthood, other factors such as lifestyle may significantly contribute to its progression. objectives: considering the primary and secondary prevention of sarcopenia, the aim of this study was to analyze associations of sb and pa with markers of muscle strength (lower limb muscle power) and muscle mass (fat mass (fm) to fat free mass ratio (ffm) in adult women and men with and without deficits in these markers. methods: participants were apparently healthy adults ( women) with a mean age . ± . yrs, employed in activities requiring office work. fm and ffm were evaluated by bioelectrical impedance analysis (bia, khz bia rjl, akern bioresearch, florence, italy akern). muscle power relative to body mass (pmax/mass) was assessed during a single two-legged jump on a force platform (leonardo mechanograph, novotec medical, pforzheim, germany) . sb and pa were assessed by accelerometry (actigraph, gt x model, fort walton beach, fl, usa) during four consecutive days ( -week+ -weekend days). the variables analyzed were time spent per day in sb, in light-, moderate-, vigorous-, moderate to vigorous-intensity pa, total pa and breaks per day of sb. multiple linear regressions were performed by stepwise to examine associations of sb and pa with muscle power and fm/ffm, separately for men and women with and without muscular deficits. for the identification of deficits (<- . sd), muscle power and fm/ffm were standardized separately for men and women having as reference their respective mean. results: linear regressions by stepwise evidenced an association of sb with muscle power in women with muscular deficit (β = - . , p = . , adjr = , %%) and an association of vigorous pa with fm/ffm in men without muscular deficit (β = . , p < . , adjr = , %). no associations were observed between sb or pa with muscle power or fm/ffm in other groups. conclusion: sb was negatively evidenced in women with muscle power deficit while vigorous pa revealed to be associated with fm/ffm in men without ffm deficit. funded by portuguese science and technology foundation; project c mup-eri/hc i/ / patricia parreira batista , andré gustavo pereira de andrade , jéssica rodrigues de almeida , aimée de araújo cabral pelizari , leani de souza máximo pereira , lygia paccini lustosa (( ) physical therapy department, ufmg -eeffto, belo horizonte, brazil; ( ) sports department ufmg -eeffto, belo horizonte, brazil) background: the practice of regular physical activity in the older people leads to the decreased of the loss of muscle mass and function with advancing age, and enhances the functionality in activities of daily living and social interaction. in addition, exercise promotes gains in the quantity and quality of muscle fibers and improves muscle strength and power, acting as a protective factor for negative health-related outcomes such as falls, frailty, and hospitalizations. regular practice of physical activity is known to modify the chronic proinflammatory condition common in the older people. probably, exercise reduces the drive of catabolic stimuli from this proinflammatory cascade, modifies the metabolism and production of cytones in tissues and organs, promoting protective and anti-inflammatory effect in the body. objectives: to compare older women who reported being active or sedentary regarding functional capacity and plasma indices of inflammatory mediators. methods: participated women ( years or older), recruited for convenience. those unable to walk were excluded; acute musculoskeletal diseases; lower limb fractures in the last year; neurological diseases and sequelae; history of cancer in the last five years and cognitive impairment (mental state mini-exam). all informed clinical and demographic data and performed the tests short physical performance battery (sppb) and timed up and go (tug). plasma dosages of stnfr and il- were by elisa method. comparison was by independent student t test. approval by the research ethics committee / ufmg (caae: . . . ). results: fiftytwo sedentary older women participated ( . ± . ys.); number of comorbidities of . ± . ; body mass index of . ± . kg/m . from the active group were elderly women ( . ± . ys.); comorbidity number of . ± . ; body mass index of . ± . kg/m . there was significant difference between groups in sppb (p = . ), tug (p = . ) and stnfr (p = . ). conclusion: the results showed that the active older women had better functional and mobility performance and worse plasma stnfr levels. in this case, one can think about the possible influence of body mass index in these older women, which should be explored in future studies. background: our research group designed a comprehensive geriatric intervention program (cgip) consisting of resistance exercise, physical activity increments, oral functional care, and a nutritional guide. we conducted a -week intervention and investigated the effects. after the short-term intervention, we followed up the all participants. we hypothesized that the follow-up could mitigate the loss of short-term intervention effects. objectives: the aim of this study was to compare physical functions before and after the -week intervention, and the end of the follow-up. methods: a total of were willing to participate in the -week cgip. we encouraged them to increase their daily steps and to carry out the program by using daily self-monitoring logs. the participants were randomly assigned to two groups [class-styled session (cs) group ; home-based (hb) group ] based on their residential districts. while cs group attended -minute weekly sessions and independently executed the program on other days, hb group did not attend the weekly sessions but received instructions on program execution. after the shortterm intervention, all participants were instructed to carry out the gcip habitually. also, three optional sessions for all participants were held in order to recommend implementation of the program. physical functions, such as knee extension strength (kes), maximum walking speed (mws), and anterior thigh muscle thickness (mt) were measured before and after the short-term intervention, and the end of the follow-up. results: of the participants identified, (cs ; hb ) took part in the measurements after the follow-up. thus, we analyzed their data. a significant interaction were observed in mws (p= . ). the -week cs intervention significantly improved mws (p< . ). but, mws in cs group significantly decreased after the follow-up (p= . ). there was no significant difference between before the intervention and after the follow-up in mws in cs group. on the other hand, no significant change was observed in hb group. significant time effects were observed in kes and mt (p< . ). both -wk interventions significantly improved kes and mt. while kes was maintained even after the follow-up, mt was significantly decreased. conclusion: the results suggested that appropriate follow-up helps to preserve short-term intervention effects. background: with the increasing prevalence of alzheimer disease and the current absence of drugs therapeutic, nonpharmacological strategies are definitively necessary. physical intervention is often proposed to aid in preventing or slowing cognitive decline. recent studies suggest that combining physical exercise with cognitive stimulation may have more global effect. objectives: we aimed at assessing effect of aerobic exercise alone or combined to intellectual exercises on major cognitive functions: attention (stroop), problem solving (hanoi tower) and working memory (digit span). subjects were trained twice a week for eight weeks. cognitive functions were assessed before training (base line), at the fourth and at the eighth weeks. to evaluate persistency of the effect, subjects were assessed one month after the end of training. methods: two groups were randomly constituted mild cognitive impairment subjects (mci) and alzheimer disease moderate patients (adm). each group was subdivided into three sub groups according to the task to be performed. aerobic exercise (pedaling) alone or combined to cognitive games presented on screen. control groups performed a reading task. results: an effect of training on cognitive functions was observed in adm as well as in mci subjects. however, only adm patient's performances were further improved by adding cognitive games. after four weeks, the observed effects were still maintained in both groups. mci results were obviously better than those of adm. there was no significant change in performances for control groups. conclusion: aerobic exercise induce cognitive improvement in adm and mci patients. combined physical exercise and cognitive games potentiated this effect mainly in adm group. this procedure has long lasting beneficial effect. this supports the necessity of regular aerobic exercise to prevent cognitive deficits in aging cognitive deficits. background: increasing physical activity represent a key therapeutic intervention to prevent the loss of mobility disability for enhancing health related quality of life. hence, we have set up a primary and secondary prevention care path through exercise training and nutrition to improve mobility and physical performances. objectives: our primary goal is to integrate a prevention care path into daily life of elders who may present a mobility disability risk. we aim to improve quality of life and mobility. methods: our program includes years or more who present a risk of developing a mobility disability. initially, we identify and screen a risk of mobility disability in wide elders communities. we diagnose mobility disability risk factors, sarcopenia and frailty, in day hospital (dietician, geriatrician and a kinesiologist). we use the ewgsop algorithm to diagnose sarcopenia. the patient then attend a -months training program, including sessions per week. sessions combine resistance exercises and balance training during minutes. we support the patient for his own project of long-term maintenance quality of life between physical activity and nutrition. results: patients have been seen after sessions. physical performance was significantly improved after months of intervention (sppb p< , , gait speed p< , and time-up-and-go p< , ) likewise grip strength (p< , ). the "sarqol" score was also significantly higher (p< . ). sub-group sppb ≤ with severe sarcopenia improve significantly more its score (+ . ± . p< , ) comparing to the overall population (+ . ± . ). moreover, there was a significant difference (p< , ) for sppb at baseline between responders ( . ± . ) and nonresponders ( . ± . ). conclusion: our intervention enhances mobility through physical performance benefits. we can make the assumption that adverse events will be occurring less and physical dependence will be delayed, regarding gait speed improvement. patients with lower physical performance are responding better than the overall population meaning that our intervention is more specially indicated for patients with severe sarcopenia. furthermore, our program sustains motivation for physical activity and exercise after months. we were able to show that it was possible to set up a comprehensive and effective care path for frail and sarcopenic elderly people. background: middle-aged adults who are pre-sarcopenic are at the highest risk of developing sarcopenia due to the progressive nature of the syndrome. objectives: to determine whether high intensity interval training (hiit) results in greater improvements in body composition, compared to a control group, in middle-aged adults with pre-sarcopenia. methods: eighty-two sedentary adults ( - yrs) with a low appendicular skeletal muscle mass index (asmi) were randomized into control (n= ) or intervention group (n= ) using stratified randomization based on age, sex and bmi. low asmi (asm/ht ) was determined by dxa (lunar prodigy, ge healthcare) using age-and sex-specific cut-scores as proposed by prado. the control group received one education session on general physical activity recommendations. the intervention was supervised, group-based, high-intensity aerobic and resistance interval training (hitt), times weekly for -weeks. an intention-to-treat mixed model linear regression, with a random effect, was used to analyse group differences for body composition. results: . % of the sample were female, the mean age was . yrs ( . ) and the mean bmi at baseline was . kg/m ( . ). people ( %) completed the intervention, people in the hitt group and in the control group. no adverse events were reported. significant group differences were observed for total muscle mass ( . kg, %ci: . - . ), leg muscle mass ( . kg, %ci . - . ), asmi ( . kg/m , %ci . - . ) and visceral fat mass our study indicated that group-based hiit is an effective, tolerable and safe exercise modality to increase total body and appendicular muscle mass, and to decrease visceral fat, in middle-aged adults with pre-sarcopenia. background: aging is related to body composition modifications and functional capacities declines. it is recognized than being active can prevent these changes and improve quality of life. however, it is unclear if gender or age influence this relationship and if a sub-type of voluntary physical activity is more efficient to maintain these physical parameters. objectives: to assess the association between current physical activity level or type and functional capacities and body composition among elderly people and to examine if age (< or >= yrs old) or sex modulate the relationship. methods: functional capacities using different validated tests (i.e. grip strength, timed up and go, sit-to-stand, muscle power, alternate step test, leg extension, vo max), body composition (fat & fat-free masses) using dxa were assessed. current global (total) and specific (aerobic, resistance or body and mind) physical activity levels (duration) were obtained through a questionnaire. multiple regressions, adjusted on age, sex and bmi, were performed to assess the relationship between current physical activity level and functional capacities or body composition. sub-group analysis, according to the sex and age (< y vs. >= y) were also performed by means of pearson correlations. results: a total of subjects ( . ± . years; women: . %; bmi= . ± . kg/ m²) were enrolled. after adjustment on confounding factors, total current physical activity level has positive impact on total fat mass (%; β=- . , p= ) and balance (β= . ; p= . ). moreover, current body & mind activities influence total fat-free mass (kg; β=- . , p= . ) and balance (β= . ; p= . ) whereas resistance activities influence fat-free mass (kg; β= . ; p= . ), fat mass (%; β=- . ; p= . ) and sitto-stand test (β=- . ; p= . ). sub-analysis shows that total physical activity level was significantly associated with fat mass, sit-to-stand test, balance and vo max in women but not in men. moreover, among people under y, the time spent on cardio activities does not affect functional capacities and body composition. nonetheless, among people aged y and over, the time spent on resistance activities is associated with functional capacities and body composition. conclusion: being active is associated with body composition and functional capacities, especially among women aged years and over. itxaso mugica-errazquin , nagore arizaga , janire virgala , julen gomez , garbiñe lozano , yune aranburu , udane elordi , maider kortajarena , ana rodriguez-larrad , jon irazusta ( ( ) background: low physical fitness, frailty and dependency are highly prevalent in people living in long term nursing homes (ltnh). multicomponent physical exercise, including strength, balance and endurance, has demonstrated to be effective for improving physical fitness and reducing frailty in ltnh. however, there is no evidence that this type of programs are capable to improve or even maintain the levels of autonomy in activities of daily living (adl) of this population. objectives: the major aim is to ascertain whether a new approach of months, individualized and progressive multicomponent program focused on functioning maintains autonomy in older adults living in ltnhs; the secondary aim is to assess the effects on frailty and physical fitness. methods: people living in ltnh, between and years, participated in this single group interventional study. inclusion criteria were: >= years, >= barthel index, >= mec- and be able to stand up from a chair and walk meters with or without one person/technical assistance. the intervention consisted of months of a progressive multicomponent physical exercise program (ep) aiming to improve the physical condition, followed by months of physical exercises focused on functional adl with the objective of maintaining/improving autonomy of the participants. barthel index was used to assess autonomy level in adl, frailty was measured by fried frailty index and short physical performance battery (sppb) was used to assess physical fitness. the study is registered in u.s clinical trial (nct ) and approved by the committee on ethics in research of the university of the basque country (m / / ). results: during the first months of ep participants lowered the score in the barthel index (p< , ). however, participants showed significant improvements in frailty (fried frailty index p< , ) and in physical fitness (sppb p< , ) . from the rd to th months, while physical fitness of participants did not change, they improved autonomy in adl, and decreased frailty non-significantly. when comparing the effects of the entire intervention, barthel index did not change significantly and physical fitness and frailty improved (sppb p< , ; fried p< , ). conclusion: this new approach of months of individualized and progressive multicomponent program focused on daily functioning maintains autonomy in activities of daily living, improves physical fitness and reduces frailty in older adults living in ltnhs. shuji sawada , hayao ozaki , , toshiharu natsume , daiki nakano , pengyu deng , toshinori yoshihara , takuya osawa , shuichi machida , hisashi naito (( ) juntendo university, chiba, japan; ( ) tokai gakuen university, aichi, japan; ( ) japan women 's college of physical education, tokyo, japan) background: in previous study, we found that low-load resistance training using own body weight and elastic band even only biweekly could induce muscle hypertrophy in older adults after weeks of training. however, it is unclear whether levels of different blood parameters before training associated with the effects of training. objectives: this study aimed to clarify whether levels of different blood parameters before training influenced the effect of low-load resistance training on lower limb muscle thickness (mt). methods: sixty-nine communitydwelling japanese subjects aged . ± . years ( women and men) volunteered for this study and participated in a lowload resistance training program using their own body weight and elastic band. the training was performed biweekly for weeks. each participant's mt at the anterior aspects of the thigh (at) was measured using a b-mode ultrasound device. further, the levels of the following blood parameters were assessed before and after the training program: serum albumin (alb), hemoglobin (hb), total cholesterol (tc), and hemoglobin a c (hba c). we checked the first quartile value of each blood parameter to establish the cutoff criteria for reduced levelsserum alb = . g/dl, hb = . g/dl, tc = mg/dl, and hba c = . %. participants were divided into low or normal groups in each blood parameter, and their data were analyzed using two-way analysis of variance. results: when using the abovementioned criteria, biweekly low-load resistance training increased mt at the at in every group after training. the interaction between time and groups was only detected with low (< . g/dl) versus normal (>= . g/dl) serum alb levels. in this case, there was no difference in mt at the at before training, but participants in the normal serum alb level group had greater mt after training than those in the low serum alb level group. conclusion: the effect of low-load resistance training on lower limb mt appears to be limited in participants with low pre-training serum alb level. objectives: it was to estimate the affect of complex -week treatment with kinesiotherapy methods on body weight loss and muscle function in patients with obesity. methods: men and women aged - years old with alimentary obesity were enrolled in the study (mean age . ± years, weight . ± . kg, bmi . ± . kg/m , waist circumstance wc . ± cm, hip circumstance hc . ± cm). the complex kinesiotherapy administered daily for week and included interactive sensorimotor trainings on double unstable platform, kinesiohydrotherapy in a pool, special complex of physical exercises in a gym and ergocycle trainings. weight, wc, hc, fall number for last weeks were measured at baseline and after the treatment was completed. muscle strength and walking speed functional tests results assessment ( -meters-walk test, up-and-go test, special tests for back and abdomen muscle endurance to static and dynamic loading) were performed at baseline and in weeks. results: there was a significant reduction in body weight ( . ± . kg at baseline vs . ± . kg in weeks; p= , ), in bmi ( . ± . vs . ± . kg/m ; p= . ), in wc ( . ± . vs . ± . cm; p= . ) and in hc ( . ± . vs . ± . cm; p= . ) in treated obese patients. -meters-walk speed increased from . ± . m/sec at baseline to . ± . m/ sec in weeks (p= . ). up-and-go test results improved from . ± . to . ± . sec (p= . ). we registered statistically significant elevation of the endurance to static loading in abdomen muscles from . ± . to . ± . sec (p= . ) and in back muscles from . ± . sec to . ± . sec (p= . ). the endurance to dynamic loading increased in abdomen muscles from . ± . to . ± . times (p= . ) and also in back muscles from . ± . to . ± . times (p= . ). fall namber markably decreased from . ± . at baseline to . ( %ci: . ; . ) after completion of treatment. conclusion: investigated complex treatment with kinesiotherapy methods promotes body weight loss, wc and hc reduction in obesity. -week special training of obese patients is associated with increasing in gate speed and lower extremities muscle strength, and it also causes improvement in static and dynamic loading endurance of back and abdomen muscles. those changes may probably improve balance function and decrease risk of falling in obese patients. thaiana pacheco, candice medeiros, rummenigge dantas, inae c. gadotti, edgar r vieira, fabrícia costa cavalcanti (department of physical therapy, florida international university, miami, usa) background: integrating technological advances into clinical practice can be challenging. physical therapists have been developing serious games/exergames for a variety of rehabilitation purposes, but uptake has been slow. games with virtual scenarios are an engaging and affordable way to encourage and increase physical activity levels. serious games have been developed to adapt virtual gaming environments to patients' needs and evolving capabilities. games can improve adherence and therapy effectiveness. the sensory and motor stimulation while playing serious games can help geriatric rehabilitation to improve mobility and balance. objectives: this study analyzed the effects of a new serious game on the balance of older adults. methods: this was a pilot quasiexperimental design study in which older adults completed six sessions of dynamic balance training using the virtualter serious game that uses the kinect sensor for motion capture. this game was developed by researchers from the federal university of rio grande do norte in brazil. the game consists of static and dynamic tasks for training balance. it involves stationary walk, lateral reaching and climbing steps up and down. it has phases with increasing the level of difficulty. the participants were evaluated before and after the program using the berg balance scale (bbs) and the short physical performance battery (sppb). t-test for dependent samples was used to analyze the pre vs. post data. results: twenty three participants participated in the study (age = ± ; sex = % women). the results indicate improvement in bbs scores (pre: ± ; post: . ± ; p = . ) and sppb scores (pre: ± ; post: ± ; p = . ). conclusion: playing the virtualter serious game improved balance in older adults. helen chan , duncan wong , cindy fan (( ) the nethersole school of nursing, the chinese university of hong kong, hk; ( ) silver yoga lab, hk) background: evidence showed that both frail and prefrail significantly increase the risk of developing or worsening disability in activities of daily living, poor quality of life and institutionalisation. yoga has been consistently reported as effective intervention in improving physical functioning in terms of balance, lower limb strength, mobility and body flexibility. objectives: to assess the feasibility of silver yoga in older adults and to examine the preliminary effects of silver yoga on their physical health. methods: this was a one group pre-test post-test study conducted in a community centre. people who aged and above, were mentally competent, home-living, and classified as prefrail based on physical phenotypes using fried criteria, were eligible to the study. the silver yoga class included eight . -hour weekly sessions delivered by two experienced yoga instructors with specialized training in silver yoga. senior fitness test (sft) was conducted to assess changes in physical health. paired t-test was used to compare the within-subject differences across -month time. results: a total of older adults were recruited. there were significant improvement in six dimensions of the sft, including upper extremity muscle strength, lower extremity muscle strength, upper body flexibility, lower body flexibility, agility and dynamic balance, and aerobic endurance (ps < . ). all participants except one completed the yoga programme, with high level of satisfaction. in addition to the effects of physical conditions, the participants also appreciated it as mind-soothing and relaxing. conclusion: the findings showed that silver yoga is well-received by older adults generally, with significant effects in improving their physical fitness. more rigorous study is needed to examine its effects in a longer term and also in a more holistic manner. ku leuven, leuven, belgium; ( ) physical activity, sports and health research group, department of movement sciences, ku leuven, leuven, belgium) background: with aging skeletal muscle tissue becomes less responsive to anabolic stimuli, eventually contributing to muscle wasting. inflammation is considered an important player in this age-related anabolic insensitivity. recent reports provide a promising role for omega- polyunsaturated fatty acids (ω- ) in (muscle) health, as they possess systemic anti-inflammatory properties and stimulate muscle anabolic signaling. objectives: we investigated whether ω- supplementation improves the systemic inflammation and muscular adaptations (i.e. strength, mass, molecular signaling) to resistance exercise in an elderly population. methods: twenty-three elderly ( - y; ♀) were randomized to receive either ω- (~ g/d) or an isocaloric amount of corn oil (plac) during weeks. after two weeks of supplementation, participants engaged in resistance exercise (re; x/week) for weeks. prior to and after completion of the intervention, muscle and blood tissue, parameters of body composition, muscle strength and functionality were assessed. results: upon re, -rm significantly improved in plac (+ . %) and in ω- (+ . %), irrespective of condition. isometric strength significantly improved in ω- (+ . %), but not in plac (- . %). muscle volume did not change following re. plasma crp levels decreased, though not non-significantly, in ω- (- . %), whereas only a small increase was observed in plac (+ . %). ω- supplementation nor re affected the muscle anabolic sensitivity (akt phosphorylation) in response to a protein bolus. conclusion: this study confirms that ω- pufas improve the gains in isometric but not in dynamic muscle strength upon re in elderly. however, this was not associated with changes in anabolic sensitivity or systemic inflammation. further analyses will investigate whether the ω- induced gains in strength can be related to systemic hormones or muscle molecular signaling (mtor signaling, inflammation). meera suresh, clarence chikusu, caroline goodger (nutrition and dietetics, st. peter's hospital, chertsey, uk) background: deconditioning is a common phenomenon in patients over years old in acute settings. it is well known that poor nutritional status has a major impact on adverse outcomes in frailty and can exacerbate sarcopenia ( ). currently, there is limited research exploring the impact of dietitians on optimising nutritional status in acute settings in older populations for frailty and sarcopenia. objectives: compare the impact of dietetic intervention on the change in frailty scores between a patient group (n= ; mean age . years) who received dietetic intervention (di) and a patient group (n= ; mean age . years) who did not receive dietetic intervention (ndi). methods: a -month retrospective study (august-december ) was undertaken at the older persons short stay unit at a district hospital in england. frailty scores were calculated based on the rockwood model of clinical frailty. dietary intake was recorded and analysed using a standardised nutritional profile of hospital meals. the di group was given standardised dietetic care including oral nutrition support and build up dietary advice. descriptive statistics were used to determine frequencies. results: the di had higher frailty scores (mean of . ; range: - ) and a higher mortality rate ( %).the ndi had a mean score of . (range: - ) and mortality rate of %. the average oral intake for energy and protein for patients in the di group prior to dietetic intervention was % lower than the espen recommendations. despite the higher frailty scores and mortality rates in the di group, progression in their frailty score was slower compared to the ndi group ( % vs %). conclusion: the results highlight the importance of a timely referral for early dietetic intervention which is crucial for optimisation of better clinical outcomes in these patients. a dietitian is a key member of the mdt and can prevent further deterioration in muscle mass and the impact on patients' frailty and independence and also slow down the progression of sarcopenia and frailty. this has long term impact on health and social services by reducing length of stay, hospital re-admissions and the increasing burden on social care. uz leuven, leuven, belgium) background: while the protein recommended dietary allowance (rda) for healthy adults is . g protein/kg bodyweight (bw)/day (d), expert groups recommend a protein intake up to . g protein/kg bw/d for older people with chronic diseases. in addition, at least - g protein (whereof at least . g of leucine) is recommended per meal. objectives: we aim to assess in (pre)sarcopenic older people the daily energy and protein quantity and quality intake, and their change due to supplementation. methods: dietary protein quantity, and quality (plant/animal source, amount of amino acids, amount of leucine and leucine distribution over a day) and dietary energy intake were calculated from four day estimated dietary records of (pre)sarcopenic participants of the enhance study (clinicaltrials.gov nct ) before and after a -week supplementation period. participants received an individualized protein supplement (resource® instant protein, nestlé) , to achieve a total (dietary + supplemental) intake of . g protein/kg bw/d. results: (pre)sarcopenic adults ( . ± . years, % female) had an average dietary protein intake of . ± . g/kg bw/d, which is higher than the rda, but below the . g/kg bw/d recommended by experts. (pre)sarcopenic adults were supplemented with protein powder, which improved the total protein intake to . ± . g/kg bw/d without affecting dietary protein or energy intake. moreover, supplementation increased the protein intake to at least g protein/meal without affecting dietary intake. more than % of dietary protein intake was of animal origin. leucine intake at baseline was insufficient at all meals, but increased to at least . g at lunch and dinner by supplementation without affecting dietary leucine intake. conclusion: community-dwelling (pre)sarcopenic older people do not reach the recommended protein intake proposed by expert groups. individualized protein supplementation results in adequate intake of protein without substantial change in dietary intake. nutrition and dietetics, internal medicine, amsterdam university medical centers, amsterdam, the netherlands) background: weight loss is a main treatment goal in obese older adults with dm . combined lifestyle interventions (cli) may be more effective in preserving muscle mass during weight loss. whether severe obese benefit similar to less obese is unknown. objectives: our probe-study showed an increase in muscle mass during cli in obese older adults ( +) with dm . do severe obese (bmi > kg/m ) benefit similarly to less obese. methods: in a post-hoc analysis, out of enrolled older adults had both body weight and protein intake data before and after a -month cli consisting of dietary advice (- kcal/day) and resistance exercise. a selection of assessments were appendicular skeletal muscle mass (asmm, by dxa), physical performance (wmax; by cycle ergometer steep ramp test), quality of life (rand- physical component summary score (pcs), visceral adipose tissue (vat, by dxa), crp, insulin sensitivity and resistance (matsuda, homa-ir; by ogtt), blood pressure (sbp, dbp). linear regression analysis was used with protein intake (g/kg, except for asmm being included in kg) as independent and assessments after -months as dependent (with assessment before intervention as confounder) for both groups bmi> (severe obese n= ) and bmi<= (n= ). results: mean age was , mean bmi was . , sex m/ f and protein intake during intervention was + gram/day. mean weight loss was - . + . kg and fat loss - . + . kg. per g protein intake increase + g muscle was preserved (p= . ). however, this appeared + (p= . ) vs + g (p= . ) for severe obese vs not severe obese. severe obese showed higher response for wmax (+ . + . (p= . ) vs - . + . ) and pcs (+ . + . (p= . ) vs - . + . ), for vat (- . + . (p= . ) vs + . + . ) and crp (- . + . (p= . ) vs + . + . ), for insulin sensitivity (matsuda + . + . (p= . ) vs + . + . ) and insulin resistance (homa-ir - . + . (p= . ) vs + . + . ), sbp (- . + . (p= . ) vs - . + . ) and dbp (- . + . (p= . ) vs + . + . ). while whole group and not severe obese group showed no significant effect. conclusion: these results suggest that severe obese might benefit even more from combined lifestyle intervention compared to less obese older adults with dm . further investigation is needed to confirm these findings and identify potential mechanisms. background: nutritional interventions have been shown to stimulate muscle protein synthesis. to optimize muscle mass preservation and gains, several factors, including type, dosage, frequency, timing, duration and compliance have to be considered. objectives: this systematic review and meta-analysis aimed to summarize these factors influencing the efficacy of nutritional interventions on muscle mass in older adults. methods: data sources: a systematic search was performed using the electronic databases medline, embase, cinahl, cochrane central register of controlled trials and sportdiscus, from inception date to nd november , in accordance with the prisma guidelines. inclusion criteria included randomized controlled trials, mean/median age >= years and reporting muscle mass at baseline and post-intervention; exclusion criteria included genetically inherited diseases, anabolic drugs/hormone therapies, neuromuscular electrical stimulation, chronic kidney disease, kidney failure, neuromuscular disorders and cancer. data extraction: extracted data included study characteristics (population, sample size, age, sex), muscle mass measurements (method, measure, unit) , effect of the intervention versus the control group, and nutritional intervention factors i.e. type, composition, dose, duration, frequency, timing and compliance. data analysis: standardized mean differences and % confidence intervals were calculated from baseline to post-intervention for the intervention and control group. a meta-analysis was performed using a random-effects model and grouped by the type of intervention. results: twentyeight articles were included encompassing participants (mean age . years, sd . ). amino acids, creatine, betahydroxy-beta-methylbutyrate, and protein with amino acids supplementation significantly improved muscle mass. no effect was found for protein supplementation alone, protein and other components, and poly-unsaturated fatty acids. high inter-study variability was observed regarding the dose, duration and frequency, coupled with inconsistency in reporting timing and compliance. conclusion: overall, nutrition alone is an effective intervention to improve muscle mass in older adults. due to the substantial variability of the intervention factors among studies, the optimum profile is yet to be established. background: physical and functional capacities decline with age. one new potential intervention is oral citrulline supplementation (cit) since cit seems to increase muscle protein synthesis, mass, size and strength, improve mobility but also decrease adipose tissue mass, particularly visceral depot in old rats. furthermore, exercise is known to be another efficient intervention. however, studies assessing cit supplementation combined or not with exercise on muscle function and mobility in older human adults are emerging and literature conclusions are needed to help health professionals. objectives: establish the potential effectiveness of citrulline supplementation combined or not with exercise on muscle function and physical performance via a systematic review of randomized controlled trials (rcts) in human aged years and older. methods: the preferred reporting items for systematic reviews and meta-analysis (prisma) statement has been followed. medline, cochrane central register for rcts and scopus databases have been searched. studies selection and data extraction have been performed by two researchers independently. methodological quality of each included studies was assessed using the quality assessment of diagnostic accuracy studies- (quadas- ) tool. results: based on prisma guideline, references have been identified. among this number, only rcts ( participants) matched the inclusion criteria (e.g rcts, age> yrs, human, cit supplementation, muscle or physical parameters) and were included in the systematic review. among these studies, / reported beneficial effects of cit on muscle mass. effects on muscle strength is reported on / studies but when cit is combined to exercise better improvements in upper muscle strength are observed. finally, / studies reported beneficial effect of cit on physical performance but suggested that cit with exercise displayed greater improvements in walking speed than exercise or cit alone. the overall quality of studies was rather high. conclusion: cit supplementation seems able to improve muscular and physical factors in specific elderly people (malnourished, women, hypertensive, obese, dynapenic-obese) compared to placebo. more importantly, cit with exercise is more efficient than exercise or cit alone. however, due to the small number ( ) and heterogeneity (dose, duration, population) of the studies, further investigations are needed to confirm its promising intervention for health professionals. background: the medical nutrition supplement fortifit (r), containing the specific nutrient combination actisyn™, is designed to support muscle building in sarcopenia (muscle loss). actisyn (whey protein, leucine and vitamin d) provides high bioavailability of leucine and essential amino acids for the muscle; the nutrients in actisyn act together to optimize the muscle protein synthesis response in a state of sarcopenia where these nutrients are often deficient. preclinical and acute human studies confirmed this mode of action. objectives: to demonstrate the longer-term effects of fortifit supplementation on muscle building in healthy and sarcopenic older adults and on muscle preservation in obese (diabetic) older adults during a weight-loss lifestyle intervention. methods: our clinical research program investigated the effects on muscle mass, strength and function in healthy and sarcopenic older adults and in obese and type diabetic patients. muscle mass was measured by dexa; strength and function by handgrip strength, -times chairstand test and short physical performance battery (sppb). all studies were randomized-controlled trials with an intervention duration of to weeks. results: a significant increase in appendicular lean mass and leg lean mass was observed in healthy older adults after weeks supplementation (p< . vs non-caloric control) [chanet, jnutr ]. in sarcopenic older adults, -week intervention increased appendicular lean mass ( . kg, %ci . - . kg; p= . vs iso-caloric control) [bauer, jamda ] . moreover, during a -week lifestyle intervention of energy restriction and resistance exercise training in obese older adults with or without type diabetes, fortifit preserved appendicular lean mass (p< . vs iso-caloric control) [verreijen, ajcn ; memelink, clin nutr ] . a significant improvement was observed in chairstand time after -week intervention in sarcopenic older adults (- . s, %ci - . to - . s; p= . vs isocaloric control), but improvements in handgrip strength and sppb (primary outcomes) were only significant versus baseline (p< . ) and not versus control [bauer, jamda ] . conclusion: the medical nutrition supplement fortifit effectively supports muscle building in healthy, sarcopenic and obese older adults. moreover, the improvement in chair-stand time observed in sarcopenic older adults is clinically relevant. background: chronic kidney disease (ckd) is commonly found in older persons and it affects the quality of life and economic burden. knowledge and health literacy have been reported as fundamental factors for persons with chronic illness to perform health behavior. however, from a literature review, relationships among knowledge, health literacy, and health behavior in older persons with non-dialysis ckd have rarely been reported. objectives: to examine relationships among knowledge, health literacy, and health behavior in older persons with chronic kidney disease. methods: nutbeam's conceptual framework of health literacy was used to guide the study. the sample recruited by purposive sampling consisted of older persons with non-dialysis stage to ckd, who sought healthcare services at a ckd clinic in a university hospital, thailand. data were collected by interviews using the questionnaires about the demographic data, knowledge about care of ckd, health literacy, and health behavior of older persons with ckd and then were analyzed using descriptive statistics and spearman's rho correlation coefficients. results: the sample consisted of men and women with their age ranging from to years (m = . , sd = . ). the analysis revealed that the sample had the mean scores of total knowledge about care of ckd, health literacy, and health behavior at a high level. health literacy was positively associated with health behavior (r = . , p = . ), but knowledge about care of ckd was not significantly associated with health literacy (r = . , p = . ), nor health behavior (r = . , p = . ). conclusion: only health literacy was significantly positively related to health behavior. although knowledge is fundamental of health literacy, it was not significantly related to health literacy nor health behavior in this study. it is explained that health literacy is the ability and skills that might link knowledge of individuals to perform behaviors. thus, healthcare providers should find strategies for enhancing health literacy of older persons with ckd to promote appropriate health behavior, thereby delaying complications. background: handgrip strength (gs) is linked to the vitality domain of the intrinsic capacity (ic) construct and is a marker of sarcopenia and frailty. low gs is a predictor of adverse health outcomes like disability onset and mortality. small increases in gs have been reported after exercise interventions, suggesting that life-course determinants rather than short-term determinants influence gs. objectives: to assess social inequality in the distribution of gs and the association of gs levels with a proxy of social determinants of health (sdh) among adults and older adults. methods: secondary analysis from wave ( - ) of the world health organization (who) study on global ageing and adult health (sage), which is nationally-representative of six countries, including , participants aged >= years and , < y. gs was computed in kg. wealth quintiles were assigned according to ownership of household assets. the last level of education of the participant and his/her mother was self-reported (the latter was used as a marker of early life sdh). social inequality was estimated using pairwise comparisons among the average of gs of the extreme social groups; and gradient inequality by the slope index of inequality (multivariate linear regression to adjust for age, sex, body mass index). estimations were weighted to consider the complex design of the sample. results: average gs was . kg for participants >= y and . kg for < y. participants >= y who reported a postgraduate level of education or higher showed % ( . kg) higher gs than their illiterate counterparts ( %, . kg, for participants < y). gs was on average % higher in participants >= y in the most top wealth quintile compared to those in the lowest quintile ( % in < y). in the multivariate models, gs was . kg higher in urban than rural participants and . kg higher among participants whose mothers had completed >= years of education compared to those whose mothers were illiterate. slope coefficients were significant after controlling for confounders. conclusion: grip strength displayed an unequal distribution among social groups and also among groups of early life exposures, which suggests that vitality as a domain of ic is shaped by the sdh and built through the life course. background: intrinsic capacity (ic) is the composite of the physical and mental abilities of an individual. the distribution and correlates of ic in older adults (oa) have not been reported using an integrative score with routinely-collected clinical data. it is not clear how ic is associated with multi-systemic biochemical age-related processes captured by alterations in standard clinical laboratory tests. objectives: to describe the distribution and correlates of ic in a population of older adults from the frailty day hospital of toulouse and to test its cross-sectional association with low or high haemoglobin or high crp, accounting for frailty status. methods: using routinely collected cross-sectional data of , first visits of oa aged + to the frailty day clinic of toulouse ( - ), we calculated an index of ic (biomarkers and validated scales for five who domains). low/high haemoglobin levels or high crp levels served as indicators of acute and middleterm multisystem disruption. we used descriptive statistics to learn the distribution of ic across sex, age, education and fried frailty categories. multivariate linear models were used to test the hypothesis that higher ic holds a negative association with the multi-system deficits depicted by altered laboratory tests. results: % of the population was female, and % was frail. our ic score has theoretical limits ( - ). overall, the ic was: mean= . ,sd= . ,min= . , max= . . on average ic men scored . (ic % . , . ) and women . (ic % . , . ). the relationship found between ic and age was not linear. frail older adults displayed % less ic than their robust counterparts and % less ic than their pre-frail counterparts. if frail oa would return to robust in this population, the average ic would potentially* rise %. disruption in haemoglobin or crp was inversely and significantly associated with the ic score after adjusting for age , sex, level of education and fried frailty status. conclusion: the population attending the toulouse frailty clinic displayed highly-heterogeneous ic levels, with frail oa showing significantly lower levels than robust oa. the association between ic and age is not linear. sex, age, education, frailty status and disruption in haemoglobin or crp levels were all significantly associated with ic in a multivariate model. background: older persons tend to be hospitalized increasingly because of the complex interaction among acute problems, age-related changed, and chronic diseases. qualified nursing care needs knowledge, understanding, and a positive attitude towards the care of older persons. however, little is known factors predict the caring behavior of nurses to care for hospitalized older persons. objectives: to examine the predictability of selected factors to explain intention to care and caring behavior for older persons of professional nurses. methods: the theory of reasoned action was used to guide the study. the proportionate stratified random sampling was used to recruit a sample of professional nurses from clinical wards providing care for older patients in a university hospital. data were collected using questionnaires and then, analyzed with descriptive statistics, pearson's product-moment correlation, and multiple regression analysis with the enter method. results: almost all of the sample were female, with their age ranged from to years (m = . ). factors related to professional nurses' intention to care were perceived caring climate in organization and attitude toward caring for older persons. also, factors related to caring behavior for older persons were perceived caring climate in an organization, intention to care, and attitude toward caring for older persons. through multiple regression analysis, perceived caring climate in an organization, attitude toward caring older persons, and basic knowledge about older persons jointly predicted . % of the variance in intention to care. together, perceived caring climate in an organization, intention to care, attitude toward caring for older persons, and basic knowledge about older persons accounted for . % of the variance in caring behavior for older persons of professional nurses. the perceived caring climate in an organization was the strongest predictor of caring behavior, whereas basic knowledge about older persons was not a significant predictor. conclusion: the findings support the notion of the theory of reasoned action. it is suggested that strategies to promote perceived caring climate in an organization, attitude toward caring for older persons, and intention to care should be established and maintained to promote caring behavior for older persons of professional nurses. background: environmental and social conditions play a major influence in the development and progression of negative health-related outcomes. they represent crucial elements when taking clinical decisions and planning the care plans of frail patients. nevertheless, they still often remain overlooked because priority is given to the clinical manifestations. objectives: the aim of this study is to explore the importance of social support in the definition of major health-related outcomes among hospitalized patients compared to other critical factors of older persons (i.e., frailty, age). methods: data were retrospectively collected from the medical records of patients aged years and older admitted to the geriatric unit of the fondazione irccs ca' granda ospedale maggiore policlinico (milan, italy). a -items frailty index (fi) was computed from clinical variables recorded during the first days of hospitalization (i.e., medical history, cognitive, functional and social assessment, physical examination, laboratory tests). mortality, length of hospital stay above the median, and risk of institutionalization were the outcomes of interest. results: we included patients (mean age . , sd . years, women . %). six patients died during the hospital stay ( . %). the median duration of hospital stay was (iqr - ) days. twenty-seven patients were discharged to other institutions ( %). the mean fi was . (sd . ). the fi showed a statistically borderline association with mortality (or . , % c.i. . - . , p= . ), and was predictive of longer length of stay (or . , % c.i. . - . , p= . ), even after adjustment for confounders. the presence of a caregiver was the only factor significantly associated with the discharge at home of patients (or . , % c.i. . - . , p= . ) at the multivariate analysis. age had no significant association with the three studied outcomes. conclusion: health systems should be organized according to an integrated model of care in order to adequately address the complex health needs of older people. social and environmental context plays a critical role in determining the person's health trajectory. social factors (as the presence of a caregiver) may play a stronger role in clinical decisions than biological or clinical aspects. background: the acute therapy team was formulated after the integration of an older persons assessment and liaison team (opal) with medical ward therapists. the team was spread across all acute areas. this team worked closely with the acute geriatric and frailty clinical team and it was recognised that length of stay, and improved patient experience and overall outcomes would be improved with earlier assessment and cga planning at the front door allowing closer collaborative working between the clinicians and therapists. objectives: to enhance service improvement and prevent the impact of sarcopenia and frailty syndromes leading to greater hospital stay and disability as a consequence of a delay to assessment by clinicians and therapists in the acute setting. through the screening of frailty syndrome risk and sarcopenia risk patients by the ed geriatrician and junior doctor, there would be a speedier response to therapy led interventions thereby reducing the conversion rate from ed and also therefore improving overall outcomes in length of stay and reduced disability through prolonged hospital stay. methods: consultant geriatrician and junior doctor (opssu team) to go to the emergency department in the mornings and see up to patients in cdu/a&e beds; the use of a the rockwood frailty score template identified those patients at risk of frailty syndrome and likely to benefit from early therapy intervention. these patients would have been highlighted as having the potential to be discharged within hours. a month data collection period from was chosen with data collected monday to friday only. data examined was categorised as follows: new patients, follow-ups; how many patients were seen on day of ed attendance vs after day of attendance?; number of patients seen by therapists same day of ed attendance number of patients not seen by therapists day of attendance; which team was looking after the patient from a clinically; how much time spent with patients; therapy led plan after initial assessment; an integrated assessment too was instrumental in the cga component of the therapy and clinical assessments. results: % of patients seen by therapists in ed are new patients referred. % of patients referred are seen on the actual date of ed attendance. the rest are seen later admission episode. % of therapy time is spent doing non-face to face tasks such as documentation. but up to % of patients have a discharge plan put in place after being seen by therapists in the ed. conclusion: a great deal of time is spent by therapists on documentation during assessment. this has a negative impact on the amount of time dedicated to clinical assessments and physiological and functional assessments required in the cga. there is a large number of patients referred by the clinical team to the therapists for review but a majority of patients are seen elsewhere during an admission episode and not in the ed. streamlined assessments and screening tools are recommended & planned for the future model of care. yi-chun cheng , li-ning peng , (( ) center for geriatrics and gerontology, taipei veterans general hospital, taipei, taiwan; ( ) aging and health research center, national yang ming university, taipei, taiwan) background: older people with frailty are at risk of adverse outcomes, such as falls, disability, hospital admission, long term care placement, poorer quality of life, and mortality, which denotes the importance of sarcopenia in the health care for older people, and integrated intervention program may prevent those. objectives: to evaluate the effectiveness of an integrated intervention program among those communitydwelling frail older people in north taiwan. methods: a total of participants over years old mild to moderate disability and mild cognitive impairment persons were recruited from a community-dwelling frail older people in north taiwan during august and july , frail older people were invited for the study. a weeks integrated intervention program was provided for all participants. they attended the hours program once per two weeks and physical activity, high protein diet education, and cognitive stimulation activity were included in the integrated intervention program. comprehensive geriatric assessments were performed before and after the intervention program, including basic demographic data, risk for malnutrition (by mna-sf), mood condition (by gds- ), cognitive condition (by mmse), weakness (by handgrip strength), exhaustion (by self-report in chs) slowness (by gait speed) and time-up-go test. pretest on the st week before intervention and post-test on the th week to compare the difference between twice evaluate consequence. results: overall, participants were identified as having pre-frailty ( . %) and frailty ( background: low appendicular skeletal muscle mass (asm), an integral component of current sarcopenia definitions, is commonly measured using bioimpedance analysis (bia). bia equations for estimation of asm are not generalizable across population groups and instrument types, potentially giving rise to inaccurate results when applied inappropriately. there is a lack of bia prediction equations for asian populations, none of which have been developed or validated for singaporean older adults. objectives: to develop a bia prediction equation for estimation of asm in communitydwelling older singaporean adults. methods: we studied healthy community-dwelling subjects (mean age . years) from the gerilabs- cohort. bia was performed using a single-frequency instrument. the reference method used for asm measurement was dual-energy x-ray absorptiometry (dxa). we first identified independent asm predictors by assessing the correlation of demographic, anthropometric and bia variables with dxa-measured asm. the best-fitting prediction equation was derived from these variables using stepwise (backward elimination and forward selection) linear regression with bootstrap validation. using asian working group for sarcopenia (awgs) cutoffs, we then compared anthropometric, strength and physical performance parameters between normal and low bia-derived asm groups. results: the derived bia equation incorporated predictorsimpedance index, weight, gender and body mass index (bmi), i.e. asm(kg) = . + ( . x impedance index) + ( . x weight) + (- . x gender) + (- . x bmi), where males = , females = and impedance index = height(cm )/resistance. the r and standard error of the estimate of this regression model were . and . kg respectively, with impedance index accounting for . % of its variability. individuals with low bia-derived asm have significantly smaller mid-arm and calf circumference and weaker grip strength, compared to individuals with normal bia-derived asm (p< . ). physical performance was similar in both groups. conclusion: we have developed a valid single-frequency bia prediction equation which can provide good estimates of asm in communitydwelling older singaporean adults. validation of this prediction equation in an independent sample of population is required to establish its accuracy and precision. ( ) faculty of sport sciences, waseda university, tokorozawa, japan) background: it has been well known that appendicular lean mass (alm) and skeletal muscle mass index (smi), which is the ratio of alm to height (m), is positively proportional to regional bone mineral density (bmd) in elderly men. however, there is limited information about these relationships in middleaged men. objectives: the purposes of this study were to investigate the difference in bmds (arms, lumbar spine, pelvis, legs, and subtotal: total body without head area) in middleaged men with low and normal smi (alm/height ≤ . kg/ m from asian working group for sarcopenia: awgs), and to determine the associations between alm, smi, and bmds. methods: three hundred and two middle-aged japanese men between and years of age participated in this study. alm and bmd measurements were taken using dual-energy x-ray absorptiometry (dxa, delphi a-qdr, hologic). results: based on the definition from awgs, the prevalence of low smi was approximately % in middle-aged men. the subjects with low smi (low smi group, n = , . kg/m ) had significantly lower body weight ( . vs. . kg), bmi ( . vs. . kg/m ), and fat mass ( . vs. . kg) compared to the normal group (n = , . kg/m ), although there were no differences in age ( vs. years), standing height ( . vs. . cm), and body fat percentage ( . vs. . %) between the two groups. bmds were significantly lower in low smi group than normal group for regional body parts (arms . vs. . g/cm ; lumbar spine . vs. . g/cm ; pelvis . vs. . g/cm ; legs . vs. . g/cm ) and subtotal ( . vs. . g/cm ). moreover, body weight, fat mass, alm, and smi were positively correlated with bmds using partial regression analysis controlling for age in all subjects, except for fat mass vs. lumbar spine bmd. in a stepwise multivariable model, alm was more closely related to bmds, except in the case of pelvis. conclusion: these results suggest that in order to maintain the regional bmd in middle-aged men, a key factor is to maintain or increase both alm and smi. background: the societies on sarcopenia have recently accepted the use of bioelectrical impedance analysis (bia) in the assessment of appendicular skeletal muscle mass (asm). several bia equations and devices have been introduced, which analyze the whole body composition, including the trunk and excluding the left arm and left leg at khz. it is necessary to measure the appendicular body segments of impedance parameters with a specific frequency (hz) that optimally analyze the muscle for valid assessment of asm. prior our study, literature-based bia equations and the two devices estimated asm at > % of r (coefficient of determination) with the significant constant-errors rated as «poor». objectives: thus, the aims of this study were ( ) externally cross-validate the equations and devices of bia on the appendicular skeletal muscle mass and ( ) develop valid equations based on appendicular bioimpedance parameters at the specific frequency (khz) that reflects the muscle for estimating asm; methods: community dwelling koreans over -year-old ( + . yrs, females and males) participated. asm was predicted using bia-based equations available in literature and bia devices and compared to dxa outcomes which is the gold standard. we conduct internal cross-validation and stepwise multiple linear regression to develop asmformulas with segmental multi-frequency bias. results: our new prediction formulas were developed by the appendicular impedance(z) index = height / (z of right arm + z of left arm + z of right leg + z of left leg)) at higher than khz and the appendicular reactance(xc) = xc of right arm + xc of left arm + xc of right leg + xc of left leg at khz. r s were over %, see wes under . kg of asm with the subject rating as «excellent» for men and «good» for women. conclusion: we found that our new protocol resulted in higher agreement with dxa and improved bia accuracy for this specific age group. clinicians can use this lower cost protocol and equations to better diagnose sarcopenia in larger cohorts with comparable to measurement of dxa. background: greater protein intake throughout the lifespan may be related to better body composition through the preservation of lean body mass during aging. objectives: we sought to determine whether an association between dietary protein intake (pi) and body fat percentage (bf) exists among women when controlling for dietary and lifestyle factors. methods: body composition and lean body mass were examined via dual-energy x-ray absorptiometry, grip strength (gs) was assessed using a hand grip dynamometer, and moderate-to-vigorous physical activity (mvpa) was measured by accelerometry. dietary intakes were estimated via threeday food logs and esha software. multiple linear regression and stepwise linear regression models were used. results: a total of women (mean ± sd; age . ± . years) finished all assessments. a full regression model (i.e., containing all covariates; r = . ; adjusted r = . ; f( , ) = . ; p < . ) was created using fat, carbohydrate, protein and leucine intake (g/day), protein quality (g/day of leucine over g/day of protein), energy intake (kcal/day), age (years), lean body mass (kg), bmi (kg/m ), gs (kg), and mvpa (min/day). only bmi (mean ± sem; beta = . ± . ; p < . ), gs (mean ± sem; beta = - . ± . ; p < . ), and pi (mean ± sem; beta = - . ± . ; p = . ) were significant to the full regression model. to verify their importance, a stepwise regression using the same variables was performed and resulted in a model (f( , ) = . ; p < . ; r = . ; adjusted r = . ) that included bmi (mean ± sem; beta = . ± . ; p < . ), gs (mean ± sem; beta = - . ± . ; p < . ), and pi (mean ± sem; beta = - . ± . ; p = . ). conclusion: greater protein intakes are associated with lower bf in women when controlling for various covariates. we theorize that greater protein intakes preserve lean body mass which results in improved body composition. more specifically, a one gram per day increase in dietary protein is predicted to decrease bf by . % when controlling for all other variables. background: muscle aging and the increased prevalence of obesity in the geriatric population create a new area of research: sarcopenic obesity. in prospective cohorts of nonhospitalized subjects, it is associated with an increased risk of developing physical limitation. hospitalization is an event with high risk of loss of independence. the impact of sarcopenic obesity during this episode isn't known yet. objectives: analyze the evolution of functional independence during a hospitalization in an acute geriatric ward, looking for a link between the presence of sarcopenic obesity and a decline of independence. early readmission, length of stay and changes in body composition during hospitalization were also examined. methods: prospective descriptive monocentric cohort study carried out in an acute geriatric ward of the pau hospital. sarcopenia was diagnosed using the european working group on sarcopenia in older people algorithm by an impedancemeter. a bmi over was used to report obesity. functional independence was rated on the adl katz scale. results: patients were included. sarcopenic obesity was diagnosed in . % of cases, sarcopenia and obesity in % and % of patients, respectively. the greatest variation in functional independence during hospitalization was observed in sarcopenic obese patients (mean variation of out of points, p= . ). a total of early readmission at month were counted, with the highest rate for sarcopenic obese ( %, but % at the sample level) (p= . ). the average length of stay was . days. conclusion: sarcopenia is common in patients hospitalized in geriatrics, and when associated with obesity, there is greater variation in functional independence and more readmissions. background: known that is sarcopenic obesity, excessive accumulation of adipose tissue is detected, with a decrease in muscle mass and strength, which is already over the age of years. modern diagnostic methods have their drawbacks for the diagnosis of sarcopenic obesity. bodpod quality and timeliness of diagnosis of signs of sarcopenia in obese patients is improved, which ultimately will contribute to an earlier targeted treatment of sarcopenia and an improvement in its prognosis. bodpod methodology can be recommended for use in complexes for the diagnosis of sarcopenic obesity. objectives: to compare the effectiveness of three methods of body composition assessment such as bioimpedans analysis (bia), air-replacement bodyplatismography (bodpod) and dual x-ray absorptiometry total body program (dxa total body) in the verification of reducing of skeletal muscle mass as sign of sarcopenic obesity in obese patients. methods: the study group included patients aged - y.o. (average age , ± , years) with bmi>= . kg/m . the control group included patients aged - y.o (average age , ± , years) of the same age without obesity with bmi . - . kg/m . body composition was tested using bia, bodpod and dxa with calculating fat, lean and skeletal muscles mass (kg) and % in all the patients. (bodpod) is the most sensitive in the verification of skeletal muscle mass reduction in obese patients. this method shows that patients with obesity have a significantly reduced muscle mass compared with normal weight or overweight subjects. background: in overweight and obesity excess energy and changes in body composition may favor the onset of metabolic derangements. combined with excess adiposity, the age-related decline in lean body mass can accelerate the development of insulin resistance and the consequences in terms of cardiovascular risk. objectives: the aim of our study was to investigate the association between the phenotype of sarcopenic obesity and cardio-metabolic risk in postmenopausal women. methods: postmenopausal women were recruited among subjects admitted to the high specialization centre for the care of obesity (casco), at the sapienza university, rome, italy. fat mass (fm) and fat-free mass (ffm) were assessed by dxa. obesity was defined as body fat >= %. appendicular skeletal muscle mass (asmm) was calculated. sarcopenia was defined as asmm/weight < sd than the sex-specific mean of a young population. the cut-point was asmm/weight< . . the lipid accumulation product was calculated: lap = (waist circumference cm - ) × triglycerides mmol/l]. the estimated glucose disposal rate (egdr) was calculated. high-sensitivity c-reactive protein (hs-crp) was measured. results: women were included (age: . ± . years, bmi: . ± . kg/m ). sarcopenia was diagnosed in . % of study participants. sarcopenic obese women were older than nonsarcopenic women ( . ± . vs. . ± . years, p= . ). lap was higher in sarcopenic obese women compared to their nonsarcopenic counterparts ( . ± . vs. . ± . , p= . ) after adjustment for age, body fat, and hs-crp levels. estimated gdr was significantly lower in sarcopenic obese women ( . ± . vs. . ± . , p= . ) after adjustment for age and body fat. an inverse association emerged between the index of sarcopenia, asm/weight, and lap (beta: - . * - , se: . * - , p= . ), independent of age, body fat, and hs-crp levels. a positive association was observed between asm/weight and egdr (beta: . * - , se: . * - , p= . ) adjusting for age, body fat, and hs-crp levels. conclusion: postmenopausal sarcopenic obese women exibithed a high lap and a low egdr, indicating increased cardiometabolic risk and decreased insulin sensitivity, respectively. l e a t h a a . c l a r k , , , todd m. manini , nathan p. wages , , janet e. s i m o n , , d a v i d w . r u s s , , b r i a n c . c l a r k , , , ( ( ) background: muscle weakness strongly contributes to mobility limitations and physical disability. the role of neural mechanisms contributing to age-related weakness have not been fully delineated to sufficiently target interventions that enhance strength and physical function in older adults. objectives: we sought to compare differences in voluntary inactivation and measures of motor corticospinal excitability in older adults with clinically meaningful muscle weakness compared to young adults and stronger adults without muscle weakness. methods: maximal voluntary isokinetic and isometric leg extensor strength, electrical stimulation of the leg extensors, and transcranial magnetic stimulation (tms) of the motor cortex were performed in older adults and young adults. outcome measures of leg extensor strength relative to body weight, voluntary inactivation (via), motor evoked potential (mep) amplitude and silent period (sp) duration during isometric leg extension contractions at %, %, and % of maximum voluntary contraction (mvc) were obtained. older adults were classified into three weakness groups based on previously established isokinetic leg strength/ body weight cut points (severely weak, moderately weak, or not weak). group differences were examined after controlling for sex. results: the older adults had % lower isokinetic strength/body weight when compared to the young adults. the severely weak older adults were % and % weaker than the moderately weak and older adults who were not weak, respectively. severely weak older adults exhibited higher levels of leg extensor via than older adults who were not weak ( . + . % vs. . + . %). severely weak older adults exhibited % longer sp's compared to the older adults who were not weak, but this difference was not statistically significant (p= . ). the severely weak older adults' mep's were approximately half the amplitude of the older adults who were not weak. regression analyses demonstrated that mep amplitude and sp duration -indices of hypoexcitability-were associated with relative strength. conclusion: weak older adults have significant deficits in their nervous systems' ability to fully activate their leg extensor muscles. additionally, motor corticospinal hypoexcitability is associated with age-related weakness, suggesting that interventions targeting the nervous system could be used to enhance muscle strength and prevent future health risks in older adults with muscle weakness. model. results: we evidenced oxidative stress in a mouse model of the pathology at different ages ( , and months) and aimed to identify the consequences of opa inactivation on redox homeostasis. increased ros levels were observed in cortices of the murine model opa +/-as well as in opa down-regulated cortical neurons. this increase is associated to a decline in mitochondrial respiration and an increase of antioxidant enzyme levels. upon exogenous oxidative stress opa -depleted neurons did not further up-regulated antioxidant defenses. finally, low levels of antioxidant enzymes were observed in fibroblasts from patients supporting their role as modifier factors. moreover, the simulations obtained with our mathematical model of complex i are able to reproduce biological experiments of quantification of ros production by complex i. conclusion: our study shows: (i) the prooxidative state induced by opa loss can be considered as a pathological mechanism (ii) differences in antioxidant defenses can contribute to the variability in expressivity and (iii) antioxidant defenses can be used as prognostic tools to gauge the severity and the evolution of the disease. (iv) furthermore, our mathematical model model of ros porduction by complex i will help to understand the dysfunctions of oxidative metabolism in opa gene related disorders. we will present the last results of our algorithm and wet laboratories experiments. amanika kumar, deepa m narasimhulu, michaela e. mcgree, amy l.weaver, aminah jatoi, nathan k lebrasseur (mayo clinic, rochester, mn, usa) background: patients with advanced ovarian cancer (eoc) are often frail and require multi-agent chemotherapy. objective: to evaluate the relationship between frailty and adjuvant chemotherapy tolerance and toxicity among women with advanced epithelial ovarian cancer. methods: women who underwent primary debulking surgery for stage iiic or iv eoc and received adjuvant chemotherapy at the same institution were identified. a frailty deficit index (fi) was derived from items representing comorbidities and activities of daily living. frailty was defined as a fi ≥ . . if data were unavailable for frailty index calculation, patients were excluded. relative dose intensity (rdi) for carboplatin and paclitaxel was calculated as the percentage of the standard dose that was actually administered and compared between frail and non-frail using the wilcoxon rank sum test. results: of the women who met inclusion criteria, . % ( / ) were frail. frail women were older ( . vs . years, p= . ), had a higher bmi ( . vs . kg/m , p= . ), and were more likely to have american society of anesthesiologists (asa) score ≥ ( . vs . %, p= . ) compared to nonfrail women. frail patients were less likely to complete cycles of adjuvant chemotherapy, ( % versus %, p< . ). despite the decrease in total cycles of chemotherapy, we did not observe significant differences in dose delays ( . vs. . %), dose reductions ( . vs . %), and severe neutropenia ( . vs. . %) between frail and non-frail women. we analyzed a subset of patients ( frail and non-frail) women received both intravenous carboplatin and paclitaxel. we observed that frail women were less likely to have a carboplatin rdi of % or higher ( . % vs. . %, p< . ) and less likely to have a paclitaxel rdi of % or higher ( . % vs. . %, p= . ). conclusion: frail women with advanced eoc undergoing adjuvant chemotherapy receive reduced rdi and are less likely to complete cycles of chemotherapy despite no increase in dose reduction, delays, and neutropenia. physician bias and patient choice may influence chemotherapy intensity decisions. further studies are needed to explore the association between frailty, chemotherapy, and survival. background: gait speed is a core component of physical frailty (pf) and, as a single measure, is correlated with important health outcomes, including mortality. immune dysregulation has been previously associated with pf -including increased il- production in peripheral blood mononuclear cell (pbmc) lipopolysaccharide (lps) stimulation assays. it is not known whether gait speed is associated with lps-stimulated cytokine production. objectives: this pilot study evaluated whether gait speed is correlated with dysregulated immune response in two populations of older adults undergoing procedures -knee osteoarthritis (oa) scheduled for knee replacement, and chronic kidney disease (ckd) approaching hemodialysis initiation. methods: older adults with ckd and older adults with knee oa underwent preoperative evaluation including gait speed (usual pace, -meter walk, best of two trials) and immune stimulation testing (in vitro, thawed pbmcs stimulated with lps at doses , . , and ug/ml, with il- quantified by elisa at , , , and hours; reported as area under the curve (auc)). correlation coefficient and p-value were calculated. results: for ckd, the il- auc of lps stimulated pbmcs was negatively associated with gait speed (lps . ug/ml r = - . , p= . ; lps ug/ml r= - . , p= . ). for oa, the correlation between il auc and gait speed was positively correlated for lps dose . ug/ml (lps . ug/ml r = . , p= . ; lps ug/ml r= . , p= . ). none of these associations were statistically significant. similar results were obtained when age was included as a covariate. conclusion: in people with ckd, increased cytokine production was correlated with decreased gait speed. in people with knee oa, results do not support this hypothesis. further studies with larger sample size are warranted. for participants with knee oa, future studies should account for severity of knee pain at time of gait speed assessment. background: skeletal muscle drives fuel utilization, and carbohydrate (cho) is a major fuel source. metabolic flexibility describes the ability to balance cho and fat oxidation efficiently in response to changes in metabolic demands or conditions. despite its role in long-term metabolic health, little is known about cho oxidation or metabolic flexibility in sarcopenic older adults. objectives: to examine resting metabolism and metabolic flexibility from a fasted to fed state after a cho-rich meal in sarcopenic versus nonsarcopenic older adults. methods: twenty-two men and women (age ± sd= ± y) were enrolled into this pilot study with either normal (non-sarcopenic, n= ) or low (sarcopenic, n= ) handgrip strength, gait speed and relative skeletal muscle index. resting metabolism was assessed in a fasted state at baseline, and metabolic flexibility was assessed after ( min, post-prandial) consuming a meal containing g of fat, g of protein, and g of a rapidly-digestible cho. respiratory quotient (rq), cho, and fat oxidation were measured with open-circuit spirometry, indirect calorimetry. fat and fat-free mass were measured with dual x-ray absorptiometry. blood glucose was assessed from venous samples using glucose oxidase methodology. results: rq was - % higher (p= . - . ) in sarcopenic participants throughout the experiment. after adjusting for fat-free mass, fat oxidation was % lower (p= . ), while cho oxidation was % higher (p= . ) at baseline for sarcopenic men and women. sarcopenic participants also exhibited delayed and limited (p< . ) postprandial increases in cho oxidation, despite greater (p< . ) increases in blood glucose. conclusion: sarcopenic individuals are more reliant on cho and less reliant on fat oxidation than non-sarcopenic adults, which is generally consistent with poorer metabolic health. when compared to non-sarcopenic adults, sarcopenia delayed and truncated cho utilization after a meal, indicating impaired metabolic flexibility in this population. impaired metabolic flexibility could be a mechanism underlying the losses of strength and physical function accompanying sarcopenia. anton de spiegeleer , , , hasan kahya , , nele van den noortgate , evelien wynendaele , tine decruy , srinath govindarajan , dirk elewaut (( ) unit for molecular immunology and inflammation, vib-center for inflammation research, ghent, belgium; ( ) department of geriatrics, faculty of medicine and health sciences, ghent university hospital, ghent, belgium; ( ) drug quality and registration (druquar) group, faculty of pharmaceutical sciences, ghent university, ghent, belgium) background: acute and chronic muscle wasting represent an important unmet clinical health problem. most pathophysiological studies suggest an effect of the immune system, primarily through catabolic cytokine productions such as il- . also endoplasmic reticulum (er) stress is considered to be an important pathway favouring muscle wasting. er stress in turn plays an important role in innate-like t cells, particularly invariant natural killer t cells (inkt cells), by controlling their cytokine production [govindarajan et al., nat. commun. ]. as such we reasoned that inkt cells may play a pivotal role in muscle homeostasis through their excessive cytokine production. previous studies have already highlighted the importance of these cells in a wide range of diseases such as cancer and metabolic disorders such as obesity. objectives: the aim of this study was to investigate the in vivo role of inkt cells in muscle homeostasis. methods: we compared wild-type (wt) versus inkt cell depleted mice (jα ko) for clinical, histological and gene expression differences in lower limb skeletal muscle. results: interestingly, we found that inkt cell depleted mice (jα ko) had a lower relative muscle weight, i.e. a muscle wasting phenotype, compared to wt mice. this clinical muscle wasting was associated with a decrease in oxidative enzymatic activity (succinate dehydrogenase histology). moreover jα ko mice showed a decreased transcription of genes involved in skeletal muscle growth and differentiation (follistatin and myogenin), sarcomere assembly (myosin- ) and neuromuscular junction function (neuronal acetylcholine receptor subunit alpha- ). conclusion: taken together, our results suggest a role for inkt cells in muscle wasting diseases and put innate-like t cells at the centre stage of immune cells controlling skeletal muscle biology. a r m a n d a t e i x e i r a -g o m e s , , s o l a n g e costa , , bruna lage , , dietmar fuchs , vanessa valdiglesias , , blanca laffon , joão paulo teixeira , ( ( ) background: frailty is a multidimensional geriatric syndrome characterised by increased vulnerability and functional decline that may be reversed if addressed early. it has been identified to be the most common condition leading to disability, institutionalisation and death in older adults. despite its known biological basis, no particular biological trait has been consistently associated with frailty syndrome so far. objectives: on this basis, the main objective of the present work was to evaluate the possible association between immunological: biomarkers and the frailty status in a group of community dwellers. methods: a group of older adults (>= years old) was engaged in this study. frailty status was assessed via fried's frailty model. the levels of several immune activation molecules -neopterin, tryptophan, kynurenine -were analysed. results: the classification of the study population was . % robust, . % pre-frail and . % frail. no significant differences were found between robust and pre-frail groups regarding serum concentrations of neopterin. although, the kynurenine/tryptophan ratio was significantly higher in pre-frail individuals as compared with robust subjects. conclusion: the preliminary data obtained suggest the activation of immunobiochemical pathways and are in agreement with previous studies that report alterations of the immune response in frail older adults. nevertheless, further investigation is encouraged and required to consistently demonstrate these findings. in future studies physical activity, nutritional, psychological, sociological and clinical features should also be considered when evaluating changes in immune biomarkers and frailty. the work developed by armanda teixeira-gomes and solange costa is supported by fct under the grants sfrh/bd/ / and sfrh/ bpd/ / , respectively. vanessa valdiglesias was supported by beatriz galindo research fellowship beagal / . background: frailty and hemoglobin count, above what would be considered clinical anemia, are two common findings in older patients and lead to an increased risk of negative health outcomes. objectives: evaluate whether hemoglobin concentration is an independent predictor of frailty and investigate possibe causal pathways in particuliar the relationship between inflammation and nutrition with hemoglobin concentration. methods: communitydwelling participants aged years or older who visited the toulouse frailty clinic between and were included in this analysis. patients underwent a comprehensive geriatric assessment and had a blood sample. a series of multivariate logistic regression models were perfomed after minimizing potential influence from age, gender, kidney function, inflammation, cognition, nutritionnal status and certain socioeconomic factors. results: hemoglobin count and frailty are significantly associated after minimizing potential influence from other covariates (p< . ). an increase in one point of hemoglobin concentration is associated with a % risk decrease of being frail (or= . , %ic= . - . ). there were no evidences of significant impact of inflammation and nutritional status in the relationship between hemoglobin concentration and frailty status (p> . ). conclusion: hemoglobin concentration is strongly associated with frailty in older adults. these results can have potentially important implications for prevention policies targeting frailty, by identifying potential patients with high risk of adverse outcomes and functional outcomes. juliette tavenier , line jee hartmann rasmussen , jan nehlin , morten baltzer houlind , aino leegaard andersen , ove andersen , janne petersen , , anne langkilde ( ( ) background: chronic inflammation is thought to be involved in the development of frailty. we hypothesized that increased monocyte inflammatory activity plays a role in chronic inflammation and thereby in frailty. objectives: to study the potential role of chronic monocyte inflammatory activity in frailty. methods: two groups of elderly adults (>= years) were included: patients with a recent admission to the emergency department (ed) and age-and sex-matched controls, without recent ed admission. data was collected at baseline and after year. participants were considered frail if they had or more of the following: hand grip strength ≤ kg for men or ≤ kg for women, gait speed ≤ . m/s, unintentional weight loss of > kg within the last months. frailty was also assessed using the frailty index (fi)-outref. we measured cognitive function (mini mental state examination -mmse) and chronic inflammation (soluble urokinase plasminogen activator receptor -supar). monocyte inflammatory activity was assessed by nf-κb phosphorylation (pnf-κb) using flow cytometry. results: participants had a mean age of . years (range: . - . ) and % were women. preliminary results show that at baseline, the patient group had a greater proportion of frail individuals compared to the control group ( vs. , p< . ). fi-outref was on average . points higher (p< . ) and supar levels % higher (p< . ) in the patient group, however, there was no difference in mmse score between the groups (p= . ). at year, although the proportion of frail individuals decreased in the patient group, it was still greater than in the control group ( vs. , p= . ). fi-outref remained elevated in the patient group (p= . ), but there was no difference in supar levels (p= . ). pnf-κb was positively associated with age in the control group (p= . ), but not in the patient group (p= . ). pnf-κb was % higher in the patient group compared to the control group (p< . ), and this was unchanged when adjusting for frailty, supar, and mmse. conclusion: the patient group was more frail and had elevated monocyte inflammatory activity compared to the control group. however, none of the frailty measures were confounders for the difference in monocyte inflammatory activity between groups. background: aging is most often accompanied by a loss of body weight: a decrease of fat deposits and muscle body weight. body mass index (bmi) in adults is considered normal if it is in the range of . to . kg / m (according to the who classification). bmi is widely used in the diagnosis of obesity. the association of bmi and cardiovascular and cerebrovascular diseases is known. objectives: the purpose of research is to identify the relationship of bmi with physical abilities and cognitive functions in long-livers. methods: long-living subjects aged . ± . years were examined. in long-livers, height, body weight were measured, calculated bmi. the level and direction of cognitive disturbances was determined by the mmse test (mini mental state examination). physical abilities were determined by the questionnaire and physical tests (tests the muscular strength in forearms and of the hands, chair stand test). results: bmi in long-livers had a normal distribution. the median bmi was . kg / m , the minimum value was . kg / m , and the maximum value was . kg / m . . % of long-livers had a bmi ranging from . to . kg / m . . % of long-livers have lost weight during the past year, including . % by kg or more. . % of long-livers could stand up of the chair. however, only . % of long-livers were able to complete the test correctly. amongst them, . % had a normal bmi. indicators of muscular strength in forearms and of the hand in long-livers who completed the chair stand test were significantly higher compared to long-livers who did not completed the chair stand test (r = . , p < . ). bmi had a positive correlation with the ability of a long-lived to wash without anyone's help (r = . , p < . ), go up and down the stairs (r = . , p < . ), do light housework (r = . , p < . ). mmse indicators also positively correlated with bmi (r = . , p < . ). the average mmse . ± . was observed with average bmi . ± . . conclusion: against the background of a decrease in the bmi indicator in long-livers, a decrease in physical abilities and cognitive functions is observed. however, there is a problem in determining the boundaries of the ratio of height and body weight for elderly people. in all likelihood, there are not linear, but more complex dependencies between bmi and functional abilities of long-livers. suparb aree-ue , inthira roopsawang , jansudaphan boontham , surinrat baurangtheinthong , yuwadee phiboonleetrakun (( ) ramathibodi school of nursing, faculty of medicine ramathibodi hospital, mahidol university, bkk, thailand; ( ) faculty of graduate studies, mahidol university, bkk, thailand) background: depressive symptom results in increasing poor outcomes and care dependency in older adults. the prevalence of depressive symptoms is common with its associated multiple factors. however, this conundrum problem is underestimated, particularly in older people living in rural areas. to promote healthy aging, understanding of the conundrum problem is essential in strengthening care quality and enhancing the quality of life in this population. objectives: to determine the relationships of the number of medication use, pain, frailty, and locomotive syndrome and their effects on depressive symptoms among community-dwelling thai older adults. methods: a cross-sectional study was employed. the sample consisted of community-dwelling thai older adults who met the inclusion criteria. data were assessed by using demographics questionnaire, thai version -question geriatric locomotive function scale: glfs- ; numeric rating scale; the reported edmonton frailty scale: refs-thai version; and the -item geriatric depression scale, tgds- . a path analysis was employed to determine the pathways linking the number of medication use, pain, locomotive syndrome, frailty to influence depressive symptoms. results: there were significant positive direct paths from pain (beta = . , p <. ) to locomotive syndrome and from locomotive syndrome to the number of medication use (beta = -. , p <. ). an inversely, the locomotive syndrome was a negative significant direct to depressive symptoms (beta = -. , p <. ). pain had an indirect effect on depressive symptoms (beta = -. , p <. ). additionally, the model explained . % of the variability in depressive symptoms. conclusion: the locomotive syndrome is a major factor influencing depressive symptoms. the complex relationship among pain, number of medication use, locomotive syndrome, and depressive symptoms should be taken into account for designing an appropriate intervention to reduce depressive symptoms among community-dwelling thai older adults. background: total knee arthroplasty (tka) is a clinical curative treatment for severe knee osteoarthritis. however, the outcomes are differences in each patient's perception. preoperative patients' expectations to functional abilities are one of important factors influencing on postoperative outcomes and satisfaction. objectives: to investigate the association among preoperative patients' expectations, postoperative functional abilities, and satisfaction to functional abilities among older adults undergoing tka at -week after surgery. methods: participants were older adults who were diagnosed with knee osteoarthritis and required to receive tka at a university hospital in bangkok, thailand. the sample was purposely selected based on the following criteria: were aged years or over, received tka for the first time, and had no cognitive impairment. the data were collected at preoperative and postoperative tka by using the demographic data questionnaire, the hospital for special surgery knee replacement expectations survey, and the knee and osteoarthritis outcome score in the part of function in daily living (koos adl) thai version. the data analysis was performed by using descriptive statistics, paired t-test, and pearson product moment correlation coefficient. results: before surgery, patients' expectations to postoperative functional abilities had a high level with the total mean score of . (sd = . ), and the item of improving ability to walk in a short distance was rated as the highest expectation. at -week after surgery, the overall functional ability had a significant improvement (t = - . , p = . ). satisfaction to functional ability also had a high level (mean ± sd = . ± . ), and the improving ability to walk in a short distance item had the highest. patients' expectations to functional abilities had a significantly low positive correlation to postoperative functional ability and satisfaction (r = . , p < . ; r = . , p < . , respectively). moreover, there was a significant moderate positive correlation between functional abilities and satisfaction to functional abilities (r = . , p < . ). conclusion: a better understanding of expectations may be beneficial in gaining knowledge, paving expectations on possible outcomes, and developing trust resulting in enhancing quality of care for thai older adults undergoing tka. background: identifying low muscle strength is a key step in many operational definitions of sarcopenia including the one recently proposed by the european working group on sarcopenia in older people- (ewgsop ). grip strength is widely used to identify people with low muscle strength. however, it is unclear what impact variation in the type of hand-held dynamometer used to measure grip strength has on the prevalence of low muscle strength. objectives: we aimed to assess the impact of estimated differences of between and kg in the measurement of grip strength when using different types of hand-held dynamometer on the case-finding of low muscle strength. methods: study participants were men and women aged - from a randomised, repeated measurements cross-over trial. maximum grip strength was assessed using four hand-held dynamometers (jamar hydraulic; jamar plus+ digital; nottingham electronic; smedley) in a randomly allocated order. ewgsop recommended cutpoints (< kg men; < kg women) were applied to estimate prevalence of low muscle strength for each device. agreement between devices was assessed using kappa statistics. results: prevalence of low muscle strength varied by dynamometer type ranging between % and % for men and, % and % for women. of the men identified as having low muscle strength by at least one of the four dynamometers, only % were identified by all four and % by just one. of the women classified as having low muscle strength by at least one of the four dynamometers, only % were identified by all four and % by only one. when comparing pairs of devices, kappa statistics ranged from . to . suggesting poor to moderate agreement. conclusion: case-finding of low muscle strength is influenced by the type of hand-held dynamometer used. it is important to identify the sources of variation in the measurement of grip strength and consider the implications of these for sarcopenia. further research is required to understand how best to standardise the assessment of each of the different components of commonly used operational definitions of sarcopenia and take account of sources of variation in these measures where standardisation cannot be achieved. background: sarcopenia is characterized by a progressive loss of skeletal muscle mass and strength associated with mortality and severe adverse events on health. for a healthy aging, the quality of life (qol) is essential and it is associated to autonomy of persons, social relations, and socioeconomic factors. objectives: to compare the qol of chilean older people with sarcopenia living in santiago de chile, according to an adapted version of the european working group on sarcopenia. methods: community-dwelling older people (mean ± sd: . ± . years; . % females) were interviewed, registering self-reported chronic diseases and the questions of short-form- health survey (sf- ). anthropometry, dynamometry and physical performance were measured. qol was measured using sf- , validated in chilean older adults. norm-based score of subscales and two summaries components -mental and physical (mcs and pcs; respectively)-were calculated using the chilean-specificscoring for older people. low score was defined as having a score ≤ th percentile of mcs and pcs. logistic regressions were estimated. results: sarcopenia was identified in . % of the sample ( . % women; . % men; p= . ). the average score of the subscales were significantly higher in non-sarcopenic adults than sarcopenic. the average of mcs and pcs were also significantly higher in non-sarcopenic adults than sarcopenic (mcs: . vs . ; p= . ; respectively; pcs: . vs . ; p< . ; respectively), and were significantly higher in men than women non-sarcopenic (mcs: . vs . ; p= . ; respectively; pcs: . vs . , p= . ; respectively). there were non-significant differences in sarcopenic adults by sex. logistic regressions demonstrated an association between sarcopenia and low mcs and pcs (or = . ; %ci: . - . ; or = . ; %ci: . - . ; respectively), adjusted by age, sex, multimorbidity, body mass index and lean/fat mass ratio. conclusion: sarcopenia was associated with a worse quality of life, which shows the impact of this pathology and the importance of developing programs for its prevention, delay or reversal. funded by fondef i p -munich sarcopenia registry (idsar): first results. uta ferrari , , marina schraml , ralf schmidmaier , , navina röcker , , sigrid adler-reichel , , christian lottspeich , , martin bidlingmaier , , benedikt schoser , , sabine krause , , martin reincke , , michael drey , (( ) department of medicine iv, university hospital, lmu munich, germany; ( ) friedrich baur institute at the department of neurology, university hospital, lmu munich, germany; ( ) preventive geriatrics study group, germany) background: since sarcopenia can be coded as disease in germany (icd-gm . ). in the same year we established the first sarcopenia registry linked with a biobank to identify modifiable, crucial risk factors for sarcopenia and its adverse outcomes. objectives: objectives of the registry are (i) how to optimize and standardize the diagnosis over in-and outpatient settings for musculoskeletal health, (ii) identification of clinical and molecular modifiable risk factors (iii) improvement of interdisciplinary treatment and prevention of sarcopenia as a new icd-code-based geriatric syndrome here we present the design as a practical approach for diagnosis in out-and inpatient care and a first descriptive analysis of influencing factors and comparison between in-and outpatients data. methods: patients older than years of age from outpatient clinic and acute geriatric ward at munich university hospital were consecutively screened by the sarc-f questionnaire. patients with high risk (sarc-f score >= ) were further assessed for sarcopenia in line with the european consensus definition (ewgsop ). among further factors assessed in the registry, we retrieved presence of further comorbidities, daily medication, nutritional status, sppb, frailty, and quality of life. results: at time of analysis, patients have been screened and within the first patients with high risk ( % women) % had sarcopenia. patients screened positive for sarcopenia have lower quality of life, even in a subclinical condition (mean euroqol (eq d-vas) = . ± . ). lower bmi ( . ± . , p= . ) and sex (p= . ) were statistically significant different for sarcopenia status, but not age (mean . ± . years, p= . ) or number of medication (p= . ) and comorbidities (p= . ). but the latter two were the most significant factors for inpatient status (both p< . ). the results underline the need for an early screening for sarcopenia in all patients older than years of age, suggested by hand grip strength in inpatients and sarc-f for outpatients. sex differences and further laboratory factors are necessary to add in sarcopenia diagnosis for precision medicine approaches. hospitalised older adults. we consider acute sarcopenia to be the last remaining acute organ insufficiency, with potentially devastating impact on function. characterising this condition will enable development of targeted interventions to ameliorate these changes. mobility disability, and incident mobility disability over . + . years. factor was associated with incident and prevalent mobility disability only, and factor was associated with only prevalent mobility disability. conclusion: muscle mass by d cr co-segregated with strength and physical performance measures, and together was associated with mobility and disability outcomes in older men. body composition measures (including dxa alm) did not co-segregate with strength and physical performance measures and together was associated with only mobility disability. background: currently, there are no registered drug treatments for the loss of skeletal muscle mass, strength and function that occurs during sarcopenia and cachexia. moreover, they are only limited relevant pharmacological screening options available. objectives: to improve in vitro pharmacological screening options, we developed a model of muscle wasting using donor primary muscle cells and our myoscreen™ platform that generates standardized myotubes for high-throughput phenotypic screening (young et al., slas discov. ( ) : - ). methods: myoblasts from four donors aged , , and years were compared in terms of proliferation, differentiation, size of formed myotubes and achr cluster formation using imaging and high content analysis. we then established an assay for muscle wasting: in each of the four donors various molecular pathways implicated in the pathogenesis of sarcopenia were activated using tnfa, tgfb or dexamethasone. results: myotubes formed from elderly patient's myoblasts displayed a reduced capacity to proliferate and differentiate, thinner myotubes and fewer acetylcholine receptor clusters. therefore, myotubes cultured using the myoscreen system continue to reflect age-related properties of donor muscle. interestingly, we also found that myotube sensitivity to atrophy stimulation increased with increasing age. myotubes were then co-incubated with growth/ repair factor igf- or hdac inhibitor, trichostatin a (tsa). both agents attenuated tnfa-induced myotube atrophy and differentiation inhibition in a dose-dependent manner. the extent of fusion index and myotube size increase was highest in myotubes from elderly subjects while myotubes from young subjects were more resistant to the protective effects of igf- and tsa. conclusion: myoscreen can be exploited to quantify age-dependent modifications in skeletal muscle fibers in vitro and identify candidate compounds that counteract the muscle wasting phenotype. andreas friedberger , alexandra grimm , wolfgang kemmler , klaus engelke , (( ) institute of medical physics, friedrich-alexander-universität erlangen-nürnberg, erlangen, germany; ( ) department of internal medicine; ( ) friedrich-alexander-universität erlangen-nürnberg and university hospital erlangen, erlangen, germany) background: sarcopenia is characterized by a progressive loss of skeletal muscle mass, which is infiltrated by adipose tissue. dual energy x-ray absorptiometry can only differentiate overall lean and fat mass. a local muscle analysis requires d imaging like magnetic resonance imaging (mri). usually, t weighted images are used for a visual grading of the amount of intermuscular adipose tissue (imat). however, a quantitative analysis requires segmentation of the fascia lata (fl, deep fascia of the thigh). objectives: our aim was to develop a highly reproducible d segmentation method in oder to quantify imat and the fat fraction of the thigh muscles using a combination of t weighted turbo spin echo (t wtse) and corresponding pt turbo spin echo (tse) dixon fat fraction (ff) images. methods: mri scans were acquired on a t scanner (magnetom skyrafit siemens) at the midthigh (length cm, slices, voxel size t w . x . x . mm³, dixon . x . x . mm³). since the fl is difficult to detect in the ff images, the t wtse images were used for segmentation. this process involved several steps, starting with a fuzzy c-mean clustering followed by several filtering steps to enhance d surface like structures representing the fl. finally, a level set algorithm was applied to obtain a closed d surface. if necessary, results were corrected manually. segmented masks were transferred from the t w to the ff images by rigid registration. imat was then segmented using a threshold determined from the histogram of the ff values within the intra-fascia region. sarcopenic ( ± y) and healthy ( ± y) male subjects were analyzed by three operators once (interoperator reproducibility) and three times by one operator (intraoperator reproducibility). results: inter-and intra-operator variability results of imat are shown in the table as mean / root mean square of the standard deviation (rms-sd) in units of the measured variable / coefficient of variation (rms-cv) in %. overall precision was excellent with errors below . %. conclusion: a semi-automatic d segmentation for the fascia of the thigh was developed. the operator impact on imat was almost negligible. background: sarcopenia a muscle disease that causes muscle mass loss and weakness. the calf circumference is a good screening test for sarcopenia in older adults in primary care. the most commonly used cutoff point is cm, but it is derived from north american studies and it may not be adequate for screening different populations that have lower height, weight and bmi. objectives: the objective of this study was to determine the ideal cutoff point for calf circumference for sarcopenia in community-dwelling older people in northeastern brazil. methods: this was a cross-sectional study of community-dwelling older people with a mean age of ± years ( % women). data on sociodemographics, anthropometrics, grip strength, gait speed, and skeletal muscle mass (bioimpedance) were collected. sarcopenia was assessed based on the diagnostic criteria suggested by european working group on sarcopenia in older people (ewgsop ). the area under the roc curve (auc) was calculated for different calf circumferences to identify the best cutoff point to determine sarcopenia among the participants. results: the prevalence of sarcopenia was %. the most appropriate calf circumference cutoff point was cm, with an auc of . , % sensitivity and % specificity. conclusion: it was found that the most appropriate calf circumference cutoff point to diagnose sarcopenia in older northeastern brazilians was cm. this is a more accurate cutoff point and will reduce the number of false positives and optimize health services in brazil. background: osteosarcopenia is a new geriatric syndrome defined as the presence of both sarcopenia and osteopenia or osteoporosis. this musculoskeletal disorder is related to higher prevalence of disabilities, falls and fractures and higher risk of mortality among community-dwelling older adults. therefore, the early diagnosis of this condition must be considered in order to reduce costs and negative impact on function. objectives: to explore the use of the infrared spectroscopy as a potential screening tool for osteosarcopenic older women (>= years old). methods: sarcopenia was identified by observing the presence of both reduction of muscle strength (grip strength) and mass (appendicular skeletal muscle mass) as suggested by the revised algorithm of the european working group on sarcopenia in older people ( ). reduction on bone mineral density was identified through bone densitometry and a t-score of <- , was adopted to classify the older women as osteopenic/osteoporotic. infrared spectroscopy through attenuated total reflection-fourier transform infrared spectroscopy (atr-ftir) was used to collect the sample information and to perform a multivariate analysis model. vibrational spectrum was obtained from serum. six samples of each group (osteosarcopenic and non-osteosarcopenic) were used to test the model and thirteen ostesarcopenic samples and fifteen non-osteosarcopenic samples were used for training. results: the most suitable model was the ga-svm with an accuracy of . %, % of sensibility and . % of specificity to differ osteopenic to non-osteopenic women. the more important selected variables found in the model were at the spectral regions: ~ cm- for carbs, ~ to cm- for nuclei acids and ~ to cm- for proteins. conclusion: infrared spectroscopy may be a promisor future method to early and easily diagnosis osteosarocopenia and prevent the harms this health condition may cause to the elderly population and minimizing costs to treat them. background: the modified european working group on sarcopenia in older people (ewgsop- ) algorithm to identify older people with sarcopenia contains three steps after initial clinical suspicion. the chair stand test, also known as the fivetimes sit-to-stand test ( sts), is one of two tests that can be used to assess muscle strength. the sts is also a component of the short physical performance battery (sppb), which is used as a measure of severity in the ewgsop- algorithm. objectives: the objective of this study was to determine whether the sts could be used to assess both muscle strength and physical performance in the ewgsop- algorithm to detect sarcopenia. methods: one hundred and ten older people aged . ± . years participated in the study. all participants were evaluated using the sppb score, as well as the timed-upand-go (tug). the ewgsop- algorithm specifies cut-off points of ≤ points on the sppb, ≤ . m/s for gait speed, and ≥ s for the tug. each participant was classified for tug and gait speed using the ewgsop- cut-offs, with stepwise discriminant function analysis used to predict the classification of participants. the remaining participants were used for cross-validation. prediction of sppb classification used the sts score in combination with predicted balance and sppb gait scores from stepwise linear regression. the total sppb score obtained using this method was used to predict sppb classification for the ewgsop- cut-off for sppb. results: the sts scores were able to predict tug and gait speed classification with % and % accuracy, respectively for the learning set of participants. the predicted sppb score had a classification accuracy of %, with % sensitivity and % specificity. when the remaining participants were evaluated, the sppb classification was correctly predicted for participants ( %), with % sensitivity and % specificity. conclusion: the sts can be used to accurately predict sppb classification in the ewgsop- algorithm to detect sarcopenia, meaning that the sts test could be used as a standalone test in an initial screening for sarcopenia. barrientos-calvo (nutritional support department and geriatric department, geriatric national hospital , san josé, costa rica) background: obesity is a disease characterized by increased adiposity with negative impact on patient health. aging process is associated with a progressive loss in muscle function, that may lead to functional decline and frailty. there are only few studies that have compared the prevalence of sarcopenia and dynapenia in obesity. objectives: the aims of this study were to determine the prevalence of sarcopenic and dynapenic obesity in elderly using the european working group on sarcopenia in older people criteria. methods: we conducted a cross-sectional study that included elderly patients with obesity from the obesity clinic since january to june . sarcopenia was defined according to the european working group on sarcopenia in older people (ewgsop ) criteria, and obesity with body mass index (bmi) > kg/m . handgrip strength was assess using a hydraulic dynamometer (jamar). bioimpedance analysis (bia) was performed. results: we evaluated persons, but only had bia data ( %). a total of older ( . ± years), % were women. mean body mass index, waist circumference, weight and calf circumference were . ± . kg/m , . ± . cm, . ± . kg and . ± . cm respectively. all patients had elevated body fat (mean %) and % had abdominal obesity. patients showed higher frequency of hypertension ( %), diabetes ( %), dyslipidemia ( %). sedentary was present in % and falls in %. mean handgrip strength and muscle mass for men and women were . ± . kg; . ± . kg and . ± . kg; . ± . kg respectively. there were ( . %) individuals fulfilling criteria for sarcopenic obesity, all women. but, dynapenic obesity was present in . % men and % women. conclusion: although the loss of muscle mass is associated with the decline in strength during aging, the decline in strength is more prevalent than the loss in muscle mass in our obeses. a large difference in prevalence of the two conditions was observed, sarcopenia obesity . % and dynapenic obesity %, respectively. barrientos-calvo (nutritional support department and geriatric department, geriatric national hospital, san josé, costa rica) background: sarcopenia is a geriatric syndrome characterized by progressive and generalized loss of skeletal muscle mass, strength, and function. several operative definitions for sarcopenia have been proposed over the past two decades. objectives: the aim of this study was to determine the prevalence of sarcopenia in costa rican longevity and health aging study (creles) using the ewgsop and ewgsop criteria. methods: to carry out the analysis, all the available cases of the creles study database in which belong to the cohort that follows in the period - were used. we analyzed community-dwelling older adults. low muscle mass was assessed using calf circumference < cm and low strength if < kg in men or < kg in women (ewgsop) vs < kg in men or < kg in women (ewgsop ). results: according to the ewgsop . % of the participants had sarcopenia, while according to the ewgsop sarcopenia was present in , % of participants. there was an increasing trend of sarcopenia by age group, it was more prevalent in women. mean handgrip strength was , kg in men and , kg in women with sarcopenia. mean calf circumference was , cm. sarcopenia was positively associated with age (or= . ; ci: . - . ), incomplete primary education (or , ; ic , ) , perceived as unhealthy (or , ; ic , - , ), antecedent of ischemic vascular event (or , ; ic , - , ), arthritis (or , ; ic , - , ), and falls ( r , ; ic , - , ). conclusion: the overall prevalence sarcopenia were significantly lower in ewgsop . prevalence of sarcopenia varies widely depending on the grip strength cut-off points applied. based on a -hour dietary recall, and poorer nutritional status as determined using must compared to their non-sarcopenia counterparts (all p<= . ). conclusion: the high prevalence of sarcopenia in community-dwelling older people who are at risk of malnutrition highlights the importance to devise targeted exercise and nutrition interventions to improve muscle health, physical performance and nutritional status. these interventions are essential to reduce the risk of progression to frailty and disability in this population group. v i n c e n z o m a l a f a r i n a , l e t i z i a s u e s c u n p u e r t a , a r a n t z a z u b i a i n u g a r t e , i ñ a k i a r t a z a a r t a b e , virtudes niño martín ( ( ) s o p h i e g u y o n n e t , c a t h e r i n e t a k e d a , philipe de souto barreto , yves rolland , sandrine andrieu , bruno vellas and the inspire study group ( ( ) background: the new geroscience field should not only be focusing on preventing age-related diseases, but should investigate the optimal maintenance of intrinsic capacity (ic): mobility, cognition, psychological, vitality and sensorial (hearing and vision) capacities as defined by the w.h.o. a better understanding about how to measure biological aging is an indispensable step that may lead to the definition of the best putative markers of aging capable of predicting healthspan. objectives: the main objective of inspire bioresource research platform for healthy aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and ic evolution. methods: the inspire platform will gather clinical data and biospecimens from subjects in the occitania region of different ages (from years or over -no upper limit for age) and functional capacity levels (from robust to frail to disabled) over years (inspire human translational research cohort). data are collected annually. between two annual visits, ic domains are monitored (with or without the help of a caregiver) each -month. once ic declines are confirmed, participants have a thorough clinical assessment and blood sampling to investigate the response of markers of aging at the time declines are detected. biospecimens includes blood, urine, saliva, and dental plaque that are collected from all subjects at baseline and then, annually. nasopharyngeal swabs and cutaneous surface samples are collected from all subjects at time-points (baseline visit and follow-up visits at m , m , m , m and m ). feces, hair bulb and skin biopsy are collected optionally at the baseline visit. results: recruitment started in october for a two years period. the identification of markers of aging will take advantage of three complimentary approaches to look for the best markers of aging: without a priori approach (transcriptomics, proteomics, lipidomics); semi a priori approach (metabolism, inflammation, cell cycle, mitochondrial network…); and targeted approach (pre-identified targets). the inspire platform will also aim to develop an integrative approach to promote novel new technologies for the assessment and monitoring of functional capacities. *acknowledgments: the inspire plateform is supported by grants from the occitania region and the european regional development fund (erdf), and co-funding by the apoc, the ctad, and the edenis, korian, pfizer, and pierre fabre groups. the promotion of this study is supported by the university hospital center of toulouse. background: energy balance is usually regulated by silent information regulator related enzyme (sirt ) and adenosine monophosphate-activated protein kinase (ampk). caloric restriction (cr) can postpone the pathological process of aging-related diseases and has a neuroprotective effect on nervous system degenerative diseases, but the mechanism is complex and not yet fully elucidated, although some of the cr effects may be mediated by sirt and ampk. objectives: to evaluate the beneficial effects of a cr diet on learning and memory ability. methods: six-week-old male c /bl mice were fed ad libitum for week before the experiment began. animals were weight-matched and randomly divided into three different groups: normal control group (nc group, n = ), high-energy group (he group, n = ), and cr group (n = ). the energy of nc diet, he diet and cr diet caloric ratio was : . : . . the total experimental duration was months. results: cr improved spatial learning and memory ability and decreased body weight and serum glucose. nissle staining showed the cell density was significantly decreased in the he group and increased in the cr group. cr decreased the expression of insulin signal pathway-related proteins such as igf- , ir, irs- , pi k, akt/pkb, and p-creb. more sirt -immunoreactive cells and fewer mtor-and s k immunoreactive cells were observed in the hippocampal in the cr group than in the nc group. cr decreased hippocampal mtor and s k protein activation and mrna expression. the expression of beclin , lc and cat b was increased and p was decreased in the cr group. the number of gfap-positive and iba- -positive cells in the cr group was significantly reduced compared to the nc group. conclusion: cr may prevent age-related learning and memory impairment via suppression of pi k/akt pathway and activation sirt / ampk/ mtor pathway in brain. background: head-down ( °) bed rest (hdbr) is a wellaccepted model to understand the pathophysiology of disuseinduced sarcopenia. human centrifugation as a measure to counteract muscle wasting during spaceflight is discussed. previous studies have observed decreases in maximal voluntary contraction force of the knee and hip-extensors of up to % following weeks of hdbr. muscle force is regulated by the recruitment of motor units (mus) and the modulation of mu firing rate. objectives: the aim of this study was to assess whether long-duration hdbr alters motor unit properties as one cause for disuse induced sarcopenia and whether human centrifugation can attenuate this decrement. methods: twelve healthy participants ( . ± . yr; ± cm & . ± . kg) were confined to -days ° hdbr in the frame of the first campaign of the agbresa bedrest study. eight received mins of artificial gravity (ag) daily via human centrifugation whereas four belonged to a control group. estimations of mu number (munix) and size (musix) in the abductor digiti minimi (adm) and tibialis anterior (ta) muscles were made using the motor unit number index method from on day preceding bed rest (bdc ) and on days (hdt ) and (hdt ). mean compound muscle action potential (cmap), munix and musix as a percent change from bdc were compared using repeated-measures anova, where muscle and time were ascribed as within-group factors and intervention a between-group factor. significance was denoted by p< . . results: both cmap and munix were unaltered over time in both muscles, irrespective of the intervention. although musix was also indifferent over time for both muscles, a significant muscle*time interaction was observed, indicating that the changes over time differed between the two muscles. conclusion: the preliminary data from the ongoing study indicate that neurodegeneration due to bedrest might affect muscles differently. there does not seem to be an effect of ag on mu number. analyses have to be repeated when the study is completed with a larger number of participants. additional histological and biochemical data will give further insight in the pathophysiology. living. soumaya msaad , geoffroy cormier , guy carrault (( ) univ rennes, inserm, ltsi -umr , f- rennes, france; ( ) neotec vision , rennes , france) background: several models have been proposed for elderly frailty detection. there is a consensus on two of them: the fried model, and the rockwood model. however, daily monitoring of the elderly is impossible with these models, whereas it is very important to detect any change as soon as possible to prevent dependency, since frailty is reversible only if early detected. objectives: the objective of this study is to propose a non-intrusive and low-cost method that anticipates frailty using depth images. crucial hypotheses are that regularity of daily activities is important for the elderly and that any prolonged change is considered as an indicator of frailty. methods: the proposed method consists in three steps: ) extraction of parameters from depth images: lying and sitting time percentage during the day, walking speed, and number of falls, visits, and exits. ) classification of the daily state using logistic regression and the extracted parameters. the daily state is considered as normal if the daily routine is maintained and abnormal if it is broken. ) computation of the weekly percentage of maintaining routine based on the classification of the nature of the day. results: tracking frailty is a difficult task that requires recording data over several months. as real data has not been collected yet, the feasibility of our approach was assessed on simulated data. in the latter, we reproduced variations of the parameters we would have extracted from real images of a patient after investigating his or her daily life. the classification of the days (normal/abnormal) led to an accuracy of % (training dataset: days, test dataset: days). a patient is considered frail when the weekly percentage of maintaining routine decreases steadily. conclusion: the preliminary results prove that in addition to being non-intrusive, a depth-imaging based approach can be a promising tool for frailty detection. anna franke , ellen freiberger , robert kob simon moskowitz , david w. russ , , leatha a clark , , , nathan p. wages , , dustin r. grooms , , brian c. clark , , ( ( ) background: one putative mechanism explaining mobility limitations (mls) in older adults (oas) is a reduction in the central nervous system's (cns) ability to rapidly drive muscle force/torque production. rapid movements can be mathematically expressed as the time derivative of force/ torque, also termed 'yank' (y). muscles are ultimately responsible for generating y, but cns input (ni) to the muscles clearly influences y. the time derivative of the voluntary electromyogram during maximal efforts is associated with gait speed (gs) and chair rise time (crt). however, since the electromyogram is influenced by non-physiological factors (e.g., subcutaneous adipose tissue acting as a low pass filter), it is difficult to fully ascribe this finding to cns deficits. theoretically, normalizing y to the time derivative of electrically evoked force/torque controls for musculoskeletal factors contributing to y (ymsk), which yields a value representing the cns's ability to rapidly produce force/torque (yni=y/ymsk). objectives: to better understand the role of the cns in mls in oas we ) compared leg extensor yni between young and oas, and ) examined the association between leg extensor yni and measures of mobility. methods: twenty-one young and fifty-nine oas ( . +/- . and . +/- . yrs) were instructed to "kick out as fast and hard as possible" against a fixed lever arm attached to a torque motor, and we quantified y between onset and -msec. next, we quantified ymsk from a supramaximal electrically evoked torque-time recording (potentiated -hz doublet) and calculated yni as described. on a separate visit six-minute walk ( mw) gs, stair climb power (scp), and x crt were measured. results: oas had higher yni vs. young adults reflecting a % reduction in central neural activation during rapid torque development ( . +/- . vs. . +/- . ; p< . ). significant associations were observed between yni and mwgs (r= . ), scp (r= . ), and x crt (r=- . ). conclusion: oas have a slower rate of volitional neural activation during rapid leg extensor torque production relative to young adults. in addition, yni explained ~ - % of the variability in measures of mobility, thereby supporting the notion that age-related reductions in the ability of the cns to rapidly activate muscles contribute to mls. background: opa mutations cause dominant optic atrophy (doa), an incurable retinopathy with variable severity and which mechanisms are still unknown. more than % of patients will endure a doa plus syndrome with ataxia, deafness or parkinsonism. the hypothesis of an oxidative stress has been proposed to explain the variability of these symptoms. objectives: that's why our goal is to improve understanding of the physiopathological mechanisms involved in this disease by developing mathematical models of the production of reactive oxygen species (ros) by the mitochondrial respiratory chain. methods: we monitored the levels of mitochondrial respiration, reactive oxygen species (ros), anti-oxidant defenses and cell death by biochemical and in situ approaches using in vitro and in vivo models of opa related disorders and model the complex i functioning with a detailed stochastic background: the sarc-f is a -question screening tool for sarcopenia. we present results for reliability and validity of the german version of the sarc-f. objectives: translation, adaptation and validation of the german version of the sarc-f for community-dwelling older adults in germany. methods: design: cross-sectional. setting and participants: community-dwelling outpatients with a mean age of . ± . years were included in the study, ( . %) of them were female. ( . %) had a positive sarc-f score of >= points. according to the definition for sarcopenia from the european working group on sarcopenia in older people (ewgsop ), eight patients ( . %) were identified as sarcopenic and ( . %) as probable sarcopenic. methods: translation and cultural adaption was composed of seven different steps that were in general based on the guidelines put forward by the world health organization. validation include test-retest and the inter-rater reliability (intra-class correlation coefficient) as well as internal consistency (cronbach's alpha). further, sensitivity, specificity, positive predictive value, and negative predictive value of the sarc-f were calculated. receiver operating characteristics (roc) analysis was performed to calculate the area under the curve. results: the translated and culturally adopted version of the sarc-f for the german language has shown excellent interrater reliability and good test-retest reliability. the internal consistency is acceptable. sensitivity ( %) and specificity ( %) for sarcopenia is low. for detecting patients with probable sarcopenia, the sarc-f in the german version has shown % sensitivity and % specificity. conclusion: due to a low sensitivity for detecting sarcopenia but an acceptable sensitivity for identifying probable sarcopenia, the german version of the sarc-f is a suitable tool for case finding of probable sarcopenia. background: skeletal muscle is a vital component of the locomotor system necessary for physical function. however, there is increasing evidence that skeletal muscle acts as a secretory organ in itself, communicating with other organ systems. acute sarcopenia is an emerging condition affecting adults following hospitalisation, which should be considered akin to organ insufficiency elsewhere. however, acute sarcopenia remains poorly characterised to date. objectives: • to characterise changes in muscle quantity, strength, physical performance, and patient-reported physical function in hospitalised older adults at one week and three months. • to determine what biological and clinical factors are predictive of changes to enable further research towards targeted interventions. methods: planned recruitment will include hospitalised patients aged years and older; elective colorectal surgery patients, emergency surgery patients, and general medical patients with acute bacterial infections. patients will be recruited to the elective cohort in pre-operative assessment clinic with repeat measures within hours of surgery, at one week, and at three months. emergency surgery patients will be recruited pre-or post-operatively with repeat measures at one week, and at three months. medical patients will be recruited within hours of admission, with repeat measures at one week, and at three months. muscle quantity will be measured by bilateral anterior thigh thickness using ultrasound and bioelectrical impedance. muscle function will be measured by handgrip strength and short physical performance battery. serum and plasma samples will be obtained prior to admission in the elective cohort, within hours of surgery in both surgical cohorts, and within hours of admission in the medical cohort. background: sarcopenia is common in old age and is associated with various diseases. as human life expectancy is projected to increase, this will pose a challenge for the global healthcare industry. since sarcopenia is highly heritable, study of its genetic underpinning can help its etiology. in the past decade genome wide association studies (gwas) have allowed the identification of new genetic markers for various conditions. identification of new genetic markers through gwas requires functional validation using cellular models in order to both prioritize and validate the potential loci/genes. objectives: demonstrate that a locus identified in gwas may affect muscle health, which is approximated by lean mass and hand grip strength. methods: gwas results are screened using a two-step scoring system which utilizes publicly available databases such as genecards, ensembl and coxpresdb to assess the relevance of a certain locus. relevant genes are then knocked out using crispr-cas in c c mouse myotube cells which are induced to differentiate. after cell harvest rt-qpcr and western blot are performed to assess mrna and protein expression, respectively. knocked out cells are also examined against wild type cells for morphological phenotype. results: slc a is a promising candidate based on: (a) muscle gwas results, (b) the expression of the gene in smooth and striated muscle tissue, (c) the lack of co-expression with other genes that have an effect on muscle; (d) mouse phenotypes associated with a mutation in the mouse ortholog slc a , (e) cell epigenetic data and (f) the topologically associated domain (tad) at chr. : , , - , , . rt-qpcr of wild type c c cells showed a fast increase in the expression of slc a 's mrna which remains constant during the entire differentiation process. conclusion: preliminary results indicate that slc a might be a promising candidate to investigate for involvement in muscle health. there is a fast and stable increase of the gene's expression during myotube formation. positive results may suggest that slc a is of importance to muscle health. to farther assess slc a role, wild type cells will be compared to knocked-out cells. this might lead to a new genetic marker for muscle health, thus extending personalized medicine in the field of sarcopenia and muscle health. jesse zanker , terri blackwell , sheena patel , kate d u c h o w n y , , s h a r o n b r e n n a n -o l s e n , s t e v e n r . cummings , , william j. evans , , eric s. orwoll , david scott , , sara vogrin , gustavo duque , peggy m. cawthon , ( ( ) background: muscle mass, strength and physical performance are independent risk factors for disability and mobility disability in older adults. it is not known how measures of body composition (muscle, lean and fat mass), strength and physical performance are interrelated or how empirical groupings of these measures relate to disability and mobility disability. objectives: to determine the relationship between measures of body composition, strength and physical performance in older men and to examine how empirical groupings of these measures relate to adverse mobility and disability outcomes. methods: muscle mass was assessed by d -creatine dilution (d cr muscle mass) in men ( . + . years) enrolled in the osteoporotic fractures in men (mros) study. participants completed anthropomorphic measures, walk speed ( m), grip strength (kg), chair stands (s), and dual x-ray absorptiometry (dxa) appendicular lean mass (alm) (adjusted for weight, body mass index or height ) and body fat percentage. factor analysis was conducted to reduce variables into smaller components. men self-reported limitations in mobility (walking - blocks, climbing steps, or carrying pounds); activities of daily living (adls); and instrumental adls at initial and follow-up visits. negative binomial models adjusted for participant characteristics were used to determine the relative risk of factors with mobility and disability outcomes. results: factor analysis reduced variables into four factors: factor , body composition, with strong loading by alm, body fat percentage, weight and muscle mass; factor , body size and lean mass, with strong loading by height, weight and alm; factor , muscle mass, strength and performance, with strong loading by walk speed, chair stands, grip strength, and muscle mass; and factor , lean mass and weight, with strong loading by alm and weight. only factor was associated with prevalent disability and background: urinary incontinence(ui) is a prevalent and costly condition that affects ~ % of older communitydwelling women.one of the contributors of ui is decreased pelvic muscle strength. objectives: to determine the effect of additional oral glutamine supplementation to kegel-exercise on pelvic floor strength and clinical parameters of ui in females. methods: it is a randomized, double-blind study. females with ui were included. digital test and a vaginal manometer were used for measuring the strength of the pelvic floor muscles. hours pad weight test was examined. participants were randomized into groups as oral glutamine gr/day and placebo. it was asked to use the supplementation and kegel-exercises to all participants for months. basic and th month measurements were compared by paired sample t -test and wilcoxon tests in each group. the progression between measurements at basic and th months was compared between the groups by using mann-whitney-u test. (clinical trials protocol id: / background: it is important to identify if middle-aged people are at risk for sarcopenia. a screening-tool identifying predictors of pre-sarcopenia early in the lifespan may inform prevention focused interventions. objectives: develop and validate a practical screening-tool to identify middle-aged adults at risk for pre-sarcopenia using data from the dunedin multidisciplinary health and development study (dmhds). methods: the dmhds is an ongoing longitudinal birth cohort study from the greater dunedin (nz) metropolitan area. the primary outcome of the screening-tool was low appendicular lean muscle index (almi) in middle-aged adults, at age . low almi was classified using prado's age-specific median cut-scores. the models were developed in % (n= ) of the cohort and cross-validated in the remaining % (n= ). possible predictors at age , were examined for associations with low almi, using univariate logistic regression. significant predictors were selected in a multivariate logistic regression to derive sex-specific prediction models. each individual in the cohort was allocated a risk-score and classified as low, medium and high risk, based on the quartile risk score. overall performance of the final models was estimated with nagelkerke r score, discrimination of the models with the area under the roc curve and calibration of the final models with hosmer-lemeshow tests. results: % of the development set and % of the validation set were female. the final models for both sexes included body mass index (b=- . , p= . ; b=- . , p= . ), vo max (b=- . , p= . , b=- . , p= . ) and grip strength (b=- . , p= . , b=- . , p= . ). the final model for females also included creatinine (b=- . , p= . ). nagelkerke's r showed that . % and . %, of the variance in low almi, is explained by the variables in the screening-tool for males and females, respectively. the area under the roc curve demonstrated good discrimination ( . ). sensitivity in the lowest quartile was . %, specificity in the highest quartile was . %. the hosmer-lemeshow p-values were respectively . and . , showing goodness of fit. conclusion: this screening-tool was able to predict the sex-specific risk of pre-sarcopenia in a large birth cohort of early middle-aged adults. clinical utility and application of this screening-tool require further investigation. background: aging-associated changes in body composition include a decrease in skeletal muscle mass, which may predispose women to physical limitations and disabilities. in women, these changes may already be accelerated during menopause, when ovarian estradiol (e ) production ceases. e , the main female sex hormone, is known to have beneficial effects on female skeletal muscle mass. objectives: the aim of this study was to investigate the effects of menopausal transition on lean body mass, lower limb muscle mass, muscle area and muscle fiber cross-sectional area in middle-aged women. methods: middle-aged women (n= ) were followed from perimenopause to postmenopause. menopausal state was defined based on repeated follicle-stimulating hormone (fsh) measurements and menstrual bleeding diaries. serum hormone levels (e and fsh; immulite ), lean body mass (lbm), right leg lean mass (dxa, n= ), and thigh muscle cross-sectional area (computed tomography (ct), n= ) were measured in peri-and postmenopause. muscle biopsies for immunohistochemistry were obtained from participants at peri-and postmenopausal phases, and muscle fiber crosssectional areas were measured. the level of physical activity (pa) from the previous months was assessed with a questionnaire (met-hours/day, n= ). statistical differences were analyzed with paired t-test and wilcoxon signed rank test. gee-modeling was used to analyze the effects of covariates during follow-up. results: the average followup time was . years (range . - . years) and there was a significant difference in e and fsh levels during the transition (p< . for both). lbm decreased . % (p= . ) and leg lean mass . % (p= . ) during the menopausal transition. no changes were found in the cross-sectional area of thigh muscles or muscle fibers. the level of pa declined during the transition (p= . ). when individual menopausal transition time and pa were controlled, only systemic e levels were positively associated with lbm (b= . , p= . ). conclusion: despite the relatively short follow-up time, significant declines were observed in lbm and leg lean mass during the menopausal transition. the decrease in lbm was associated with lower systemic e level. therefore, it seems that although pa might slow the decrease in muscle mass, estradiol loss is one key factor in whole body muscle loss during menopausal transition. hiroyuki shimada , takehiko doi , sangyoon lee , kota tsutsumimoto , seongryu bae , sho nakakubo , keitaro makino , hidenori arai (( ) department of preventive gerontology, center for gerontology and social science, national center for geriatrics and gerontology, aichi, japan;( ) national center for geriatrics and gerontology, aichi, japan)background: in , the european working group on sarcopenia in older people met again (ewgsop ) to update the original definition of sarcopenia. ewgsop uses detection of low muscle quantity and quality to confirm the sarcopenia diagnosis, and identifies poor physical performance as indicative of severe sarcopenia. however, it is not clear that the relationships between the revised definition of the sarcopenia and disability incidence in japanese older adults. objectives: to examine the associations between sarcopenia for ewgsop criteria and disability incidence among community-dwelling older japanese individuals. methods: a total of older adults participated in the study ( women; average age, . ± . years) form a japanese national cohort study called the ncgg-sgs. skeletal muscle mass was assessed using a bioimpedance analysis device and handgrip strength and walking speed were measured as physical performance. we used the cut-points of the asian working group for sarcopenia to determine the low muscle mass and low physical performances. the participants were divided into non-sarcopenia, sarcopenia, and severe sarcopenia groups. the incidence of disability was determined using data collected by the japanese longterm care insurance system over months. results: the prevalence rates of sarcopenia and severe sarcopenia were . % and . %, respectively. the participants with sarcopenia, included sarcopenia and sever sarcopenia, showed higher risk of disability incidence than those with non-sarcopenia (hazard ratio [hr]: . , % confidence interval [ % ci]: . - . ). in analysis between non-sarcopenia and sarcopenia or severe sarcopenia, although the association between disability incidence and severe sarcopenia remained significant (hr: . , % ci: . - . ), there was no significant association in sarcopenia (hr: . , % ci: . - . ). conclusion: severe sarcopenia combined low muscle mass and low physical performance could have a higher risk of disability than healthy older adults or older adults with low muscle mass alone. further studies are needed to determine whether sarcopenia without poor physical performance is associated with disability incidence.background: sarcopenia is one of the biological hallmarks of frailty that has been associated with adverse events in older adults undergoing cardiac surgery. dual x-ray absorptiometry (dxa) is a recommended modality to measure muscle mass, however, dxa may be less accurate in acute cardiac patients due to the confounding effects of peripheral edema and fluid shifts. objectives: the study aims to determine if sarcopenia as measured by a combination of dxa and timed chair rises is associated with mortality in older adults referred for cardiac surgery. methods: a convenience sample of hospitalized older adults being evaluated for cardiac surgery was prospectively enrolled at the jewish general hospital. after a questionnaire and physical performance battery, patients underwent a dxa scan (ge lunar) to measure their appendicular muscle mass (amm). patients were categorized as sarcopenic based on the european working group guidelines if they had low amm defined as < kg/m in men or < kg/m in women and low muscle strength defined as chair rises > seconds. multivariable logistic regression was used to test the ageand sex-adjusted association between sarcopenia and allcause mortality. results: the cohort consisted of patients with a mean age of . ± . years and % females. the interventions were isolated coronary bypass in %, valve surgery in %, and decision not to proceed with surgery in %. the mean amm was . ± . kg in men and . ± . kg in women. the prevalence of sarcopenia was % (n= ), similar in men and women. sarcopenia was not associated with -year mortality (or . , % ci . - . ) and, in a separate model, neither was low amm (or . , % ci . - . ). slow chair rise time was associated with higher -year mortality (or . , % ci . - . ). when patients with heart failure and reduced ejection fraction were excluded, sarcopenia appeared to be more prognostic (or . , % ci . - . ) although it did not reach statistical significance. conclusion: lower-extremity muscle strength, but not dxa-based measures of muscle mass or sarcopenia, is predictive of survival in hospitalized older adults referred for cardiac surgery. background: the "blue zone" are limited areas with a high prevalence of centenarians, with rather homogeneous characteristics, life styles and environment." this blue zone, located in the nicoya peninsula, is in the province of guanacaste. even though costa rica has this blue zone, there are no studies that characterize the prevalence sarcopenia in the centenarians of the region. objectives: the aim of this study was to determine the prevalence of sarcopenia on centenarians from nicoya, costa rica, using the ewgsop criteria. methods: this is a cross-sectional study using a population base of community-dwelling centenarians from guanacaste. antropometric measures, weight, height and strength were assessed. to assess the nutritional state, the mini nutritional assessment (mna) was used and activities of daily living (adl) scores. low muscle mass was assessed by calf circumference < cm and low strength if < kg in men or < kg in women. results: the mean age of the patients were . ± . years. from this group, ( . %) were men and ( . %) were women. patients showed comorbilities: hypertension ( . %), diabetes ( . %), copd ( . %), cancer ( %), osteoarthritis ( %) and depression ( %). mean body mass index, weight, brachial and calf circumference were . ± . kg/m , . ± . kg, . ± . cm and . ± . cm. mean handgrip strength was . ± . kg. the mean score for the mna test was . ± . and adl score . ± . . with respect to sarcopenia prevalence, a total number of ( . %) subjects were detected, ( . %) men and ( . %) women fulfilled the criteria. according to the nutritional status, patients with sarcopenia had malnourishment, were on nutritional risk and had a good nutritional state. from the sarcopenic centenarians, at least % of the subjects had dependency with adl. conclusion: we had high prevalence sarcopenia in centenarians from the "blue zone". there are few studies in centenarians, but using the ewgsop criteria, it is the first in latin america. background: sarcopenia is a geriatric syndrome characterized by low muscle mass and low muscle function and/or reduced physical performance. malnutrition is a major risk factor for sarcopenia. there is limited data on the prevalence of sarcopenia in community-dwelling older people who are at risk of malnutrition in singapore. objectives: the objectives were (i) to determine the prevalence of sarcopenia and its components i.e. low handgrip strength, low appendicular skeletal muscle mass index (asmi) and low gait speed based on the asian working group for sarcopenia consensus (chen et al., ) , (ii) to describe the characteristics and dietary intake of older adults with sarcopenia to those without sarcopenia. methods: a total of community-dwelling older adults (>= years) who were at risk of malnutrition (malnutrition universal screening tool; must score >= ) took part in this study. sarcopenia was diagnosed by low muscle mass (asmi using bioelectrical impedance analysis) plus low muscle strength (handgrip strength) and/or low physical performance ( -meter usual gait speed). anthropometric measurements, dietary intake, and short physical performance battery (sppb) were also collected. results: over % of participants had a charlson comorbidity score of . the overall prevalence of sarcopenia was %; . % had low asmi, . % had low handgrip strength and . % had low gait speed. participants with sarcopenia were significantly older, shorter, and with lower body weight and bmi, mid-upper arm circumference, calf circumference and bone mass compared to those without sarcopenia (all p< . ). they also had lower physical functions as measured using handgrip strength and endurance, leg strength, and sppb score than those without sarcopenia (all p<= . ). additionally, older adults with sarcopenia had lower total energy intake and energy-adjusted protein intake background: the prevalence of sarcopenia varies according to the diagnostic criteria used, however it is an important geriatric syndrome related to a worse functional state in the elderly. very older adults are often excluded from clinical trials. objectives: the aim of this observational prospective study is to describe the prevalence of sarcopenia in community very older adults with high comorbidity. methods: we included patients who enter the geriatric day hospital of the hospital of navarra, spain, aged more than y, underwent bioelectrical impendance analisys (bia), measurement of hand grip strength (hgs), gait speed (gs), short physical performance battery (sppb), mini-nutritional assessment (mna-sf), barthel index and cumulative illness rating scale-geriatric (cirs-g). sarcopenia were defined according to ewgsop ( ). the study begining in and it is actually ongoing. we registered variables at baseline, and at the time , and months. all-cause mortality were registered. results: we present the preliminary results of baseline value. we icluded patients ( . % men, . ± . y). sarcopenia were present in participts, vithout sex differences. sarcopenic vs no-sarcopenic patiets were older ( . ± . vs . ± . y) (p< . ) and they presented worse nutritional status (bmi . ± . vs . ± . kg/m ) (p< . ), mna-sf ( %ci - ) vs ( - ) (p< . ). sarcopenic patients presented lower barthel index ( , %ci - vs , - ) (p= . ), but we have no observed differnces nor in the sppb , %ci - in sacropenic, vs , - in no-sarcopenic participats (p= . ), neither in comorbididy index (cirs-g , - vs , - respectivelly) (p= . ). sarcopenia is significantly associated with higher mortality (hr . , %ci . - . ) (p= . ). at the present time the mean follow-up is . ± . months. at months in patients ( %) the sarcopenia reverted, and we have observed new sarcopenic cases ( %) (incident sarcopenia). conclusion: sarcopenia is highly prevalent in very older adults with high comorbidity. sarcopenia is associated with malnutrition and with higher mortality. background: disability is a multifactorial trait that contributes substantially to decline of health/wellbeing and increases steeply with age after midlife. progress in genomewide sequencing has created the potential for discovering genes influencing various health-related traits. the vast majority of such studies focus on the genetic bases of different traits assuming that they have independent mechanisms. as conceptualized by geroscience age/aging are major risk factors of geriatric traits of distinct etiologies. accordingly, the same mechanisms can predispose not to just one, but to a large fraction of geriatric conditions. objectives: identify the common genetic architecture of various traits by discovering the genetic architecture of complex multifactorial trait such as disability. methods: genome-wide association study of disability in a sample of , subjects from five studies with , disabled individuals from the women's health initiative (whi) genomics and randomized trials network, whi memory study, cardiovascular health study, framingham heart study, and health and retirement study. disability was defined as having at least one of four basic activities of daily living impairments (bathing, dressing, getting out of bed, and walking). results: we identified promising disability-associated single nucleotide polymorphisms (snps) in loci at p< - . four of them attained suggestive level of significance, p< - . in contrast, polygenic risk scores (prs) aggregating effects of minor alleles of independent snps that were adversely or beneficially associated with disability showed highly significant associations in meta-analysis, p= . × - and p= . × - , respectively, and were replicated in each study. the analysis of genetic pathways, related diseases, and biological functions supported the connections of genes for the identified snps with disabling and age-related conditions primarily through oxidative/nitrosative stress, inflammatory response, and ciliary signaling. we identified musculoskeletal system development, maintenance, and regeneration as important components of gene functions. conclusion: the discovery of adverse and beneficial prs for a multifactorial trait of distinct etiologies such as late life disability supports the concept of geroscience. the beneficial and adverse gene sets may be differently implicated in the development of musculoskeletal-related disability with the beneficial set characterized, e.g., by regulation of chondrocyte proliferation and bone formation, and the adverse set by inflammation and bone loss. key: cord- -utztcf l authors: renner-micah, anthony; effah, john; boateng, richard title: institutional effects on national health insurance digital platform development and use: the case of ghana date: - - journal: responsible design, implementation and use of information and communication technology doi: . / - - - - _ sha: doc_id: cord_uid: utztcf l the purpose of this study is to understand institutional effects on digital platform development and use for national health insurance in a developing country. information systems research on digital platforms for the health sector has focused more on healthcare. less research exists on health insurance. this study, therefore, addresses the research gap by focusing on digital platform for national health insurance service in a developing country. the study employs qualitative, interpretive case study as methodology and institutional theory as analytical lens to investigate regulative, normative, and cultural-cognitive institutional effects on digital platform development and use for national health insurance in ghana. the findings show the institutional enablers as: ( ) health-seeking culture; ( ) mobile network penetration and use; and ( ) appropriate laws and regulations. conversely, the constraints are ( ) unstructured supplementary service data (ussd) functionality; and ( ) extended family system. the purpose of this study is to understand institutional effects on digital platform development and use for national health insurance in a developing country. digital platforms are characterised as having layered modular architecture with a core module and loosely-coupled components [ ] . by their nature, digital platforms facilitate change and evolution of their use through re-configuration of their architecture and components. there is widespread use of digital platforms in various organisations and sectors [ , ] . within the developing country health sector, some health insurance organisations have implemented digital platforms while others are in the process of doing so amidst some challenges. digital platform development for health insurance is underpinned by the need for efficient operational processes and effective service delivery [ ] . unlike traditional information systems (is), which limit access to internal users for specified times, digital platform extends access to external users [ , ] such as subscribers anytime anywhere. generally, literature on digital platforms for the health sector has focused more on health care [ , ] . less research, therefore, exists on health insurance as an important sector for providing health care financing, especially in relation to national health insurance in developing country context. following this research gap, the research question for this study concerns how regulative, normative and cultural-cognitive institutions affect digital platform development and use for national health insurance in a developing country. to address the research question, the study employs institutional theory [ ] as analytical lens and qualitative, interpretive case study [ ] as methodology to gain insight into digital platform development and use for national health insurance system in ghana, as a developing country. ghana was chosen because it has recently migrated its national health insurance from traditional information system environment onto a digital platform to improve its operational processes and service delivery. the rest of the paper is structured as follows. the following section reviews relevant literature on digital platforms and the health sector. the next section presents institutional theory as the analytical lens for data analysis. the section after describes the research setting and the methodology. the subsequent section reports on the case description. the section after focuses on analysis and discussion, while the final section presents the conclusion. digital platform is a facilitator of multi-sided activities. is research views digital platform as an organisational and technological innovation for product development and transactions [ ] . several digital platforms have emerged over the last several years in different sectors [ ] . these platforms are underpinned by computing and network infrastructure that allow distributed actors to interact and transact [ ] . the architecture builds on components that have well-defined application programming interfaces (apis). the apis allow interconnection and uses in new ways than initially intended [ ] , which make them engine for innovation in service delivery. vassilakopoulou et al. [ ] examine the introduction of e-health platform to understand how inclusiveness was pursued in relation to the political orientation of platform development, coordination of work among multiple contributors, and handling of technical heterogeneity. furstenau and auschra [ ] also investigate strategies to implement and scale digital platforms in highly-regulated settings such as health care. the authors observed that openness on code and content layers fuel platform growth and contribution. however, financial risks and uncertainties in health care regulations can result in platform failure and avoid opportunities to achieve potential benefits. implementing and scaling digital platformespecially in health care-based organisationsis a difficult task and requires the resolution of tensions around autonomy-related benefits and control [ , ] . digital platforms exhibit four dimensions: infrastructure, core module, ecosystem, and service dimensions [ ] . this research focuses on the service dimension. the service dimension is the application of specialised competences (knowledge and skills) through deeds, processes, and performances for the benefit of another entity or the entity itself [ ] . because an organisation can always do better at serving clients, the service dimension views digital platform development and use as a continuous process directed at improving service delivery. despite the benefits offered by digital platforms, we are still less informed about how they support health insurance, as the focus has so far been on the health care sector. in the words of rye and kimberly, "we still do not know as much as we would like, and what we do know, we may not know for sure" [ , p. ]. the theoretical foundation for this study is institutional theory of organisations [ , ] . the fundamental concept of the theory is institution, which refers to established social structures such as laws, norms, culture and practices that influence people's thinking and behaviour in societal and organisational contexts [ ] . moreover, institutions are classified into three pillars, namely regulative, normative, and cultural-cognitive. first, the regulative pillar explains how laws, rules and regulations enable or constrain behaviour of actors [ ] . it explains how people need to conform to rules or attract punishments if they break the rules [ ] . as this study concerns health insurance, regulative institutions are the acts of parliament and laws that regulate behaviour in the sector. second, the normative pillar is based on agents' social obligations, which are observable through values and norms [ ] with the aim of guiding and promoting certain preferred behaviours [ ] . they specify how things should be done, how goals should be set and legitimate means to pursue them [ ] . in this study, normative institutions refer to established norms, traditions and practices in national health insurance services. finally, cultural-cognitive institutions are the taken-for-granted customs, traditions, and assumptions that control the thinking process and actions of social actors [ ] . in this study, cognitive institutions refer to the thinking and decision-making patterns of actors in the national health insurance sector. in theory, the three pillars are only separated for analytical purpose [ ] . in practice, they work in combination. within a given context, one pillar may dominate the others. in is research, institutional theory has been recognised as useful for analysing change and stability related to information technology and organisational elements [ ] . the motivation for choosing it as the theoretical foundation in this study is based on its useful concepts to understand the effects of normative, regulative and cultural-cognitive factors on digital platform development and use for national health insurance in a developing country. this study forms part of a larger research project into health insurance platformisation in a developing country. the current study focuses on a digital platform initiative and the regulative, normative and cognitive institutional effects on the process and the outcome. this research is based on a single case study method of the national health insurance in ghana. following the interpretive paradigm [ , ] , this study seeks to understand the interaction between digital platform development and use in health insurance and the effects of the institutional environment. interpretivists argue that organisations are not static and that the relationship between people, organisations, and technology evolve. the motivation for choosing qualitative, interpretive case study approach is based on the understanding that the research phenomenon and its context can be understood through the meanings that participants assign to them within and their institutional environment [ , ] . data collection occurred from june to september . in line with the interpretive case study tradition [ ] , this study obtained data from multiple sources, including interviews, documents, observations, and websites. the multiple data sources included semi-structured interviews with key informants who had knowledge and experience with the digital platform initiative, its implementation, and outcomes. the key informants were selected through purposive and snowball sampling [ ] based on the relevance of their role in understanding the phenomenon. a total of thirty-two ( ) interview participants were selected for this study. the participants included one director of mis, two deputy directors for business systems and claims management, respectively. other participants were ten regional ict coordinators, two data center administrators, one database administrator and one senior manager ict for business systems. additional data came from discussion with ten district mis officers and five health insurance subscribers. interviews lasted between min and two hours, were tape-recorded, transcribed and verified by participants. the researchers also obtained further data from observing the digital platform modules through demonstrations and walkthroughs organised by the national health insurance it staff. in addition, documentary data were gathered from project documentation and reports as well as from websites. based on the interpretive tradition, data analysis occurred alongside data gathering [ ] . the analysis occurred at two stages. the first stage was based on inductive thematic analysis. the process involved inductively deriving concepts from the collected data to identify themes related to the development, use and outcome of the digital platform and the roles of stakeholders to inform the case description. the second stage was theory-based analysis. under this approach, concepts from institutional theory were used as sensitising devices to identify regulative, normative and cultural-cognitive institutions as enablers and constraints of the development and use of national health insurance digital platform. from the interpretive analysis perspective, the goal of the analysis was not to test the theory, but use it as a sensitising device to guide the analysis [ ] . where necessary, follow up with the interview participants were undertaken to verify emerging findings or seek additional data in line with the hermeneutic circle. ghana, with an estimated population of million as of and classified as a middle-income country, is a developing country in africa. health care financing has gone through a chequered history in ghana since independence in where all governments have pursued, with varying degrees of success, several policies, and programmes to accelerate economic growth and raise the living standards. the national health insurance scheme (nhis) was established under act of by the government of ghana to provide essential health care services to persons' resident in the country through district mutual health insurance scheme (dmhis) and private health insurance schemes. the mission of the scheme has been towards securing the implementation of the national health insurance policy that ensures access to essential health care services for all residents of ghana and drive universal health coverage [ ] . in order to qualify as a member with the national health insurance, residents need to register first with the scheme and be given some form of identification to visit the health provider and receive health care for free. at the onset of the scheme in , dmhis used manual means to register and identify members or subscribers as they are known. from to , dmhis attempted some level of automation with mix results. the software installed at the dmhis were on standalone computers with no network connectivity to undertake data entry. with the exponential growth in membership of the scheme from came problems with accessing health services. from , the nhis introduced several digital interventions including a centralised database and a biometric system (bms) to address operational challenges which included dwindling or stagnated growth. moreover, the systems introduced produced unintended consequences of long queues and citizens waiting several hours and sometimes days in rural areas at the dmhis to register to access health care. essentially the systems introduced up to were not client-side friendly (for health insurance subscribers to access services) resulting in long queues and waiting times at dmhis offices. the members of the nhis have been mostly at the receiving end of unintended consequences resulting from digital technology led attempts at digital service innovation. first, the non-portability of the scheme and silos of client-facing systems rendered accessing health care problematic for nhis members. as a result, the scheme recorded stagnated or dwindling growth. there were also the intermittent shortages of consumables needed to ensure a very smooth registration process as well as the constant breakdown of biometric equipment. a senior management official with the scheme recounts: "we are at the crossroads if you ask me as a scheme where technology is driving the way things ought to be done; so, services, services, services is something that we want to take to the very next level." conceptualised in , the digital platform development received funding from the international labour organisation (ilo) to boost membership registration in order to meet the united nations universal health coverage goals. a prototype version of the platform was initially developed from which it was scaled to pilot and production. modules of the platform include a payment system linked to a mobile service aggregator. the payment module channels payments between nhis members using the mobile renewal application on their mobile devices and nhis digital platform over the mobile telecommunications network of the participating telecoms companies vodafone, mtn and airteltigo. it also includes an application programming interface (apis) to integrate with health provider platforms for authentications. the mobile renewal application was piloted successfully in two districts in ghana and eventually rolled out nationwide from december . the mobile renewal part of the solution uses unstructured supplementary service data (ussd) to provide messaging service to health insurance members, including the renewal of their membership and payment of premium. the mobile application sends sms reminder before the expiration of the subscribers' eligibility. the reminder offers the option to complete payment of the insurance premium immediately after the sms. insurance subscribers can check when their policy is due to expire. other features available within the application is the ability to view the benefits packages as well as a comprehensive list of medicines. service benefits to members expected from the platform include improved member renewal and registration, and reduced waiting times at dmhis offices. in driving the schemes overall policy goal of attaining universal health coverage, the digital platform is also expected to eliminate process bottlenecks to increase nhis penetration in ghana by allowing members to renew their policies at the comfort of their homes without having to queue at district offices. the nhis continued to implement the mobile membership renewal and digital authentication system across all its district offices nationwide since the national roll-out in december . the response from the nhis membership and providers on the use of these initiatives have been very positive. membership and claims check code authentication are helping to improve upon the validity of membership numbers and cost containment in claims payment. through this process, a comprehensive analysis of membership and claims validity checks can be undertaken from which appropriate punitive measures for invalid claims submission can be taken. there is now the possibility to link legacy data to new data generated from the project's implementation to drive more timely and actionable insights, significantly improving efficiency of nhis operations and service accessibility. importantly, more wide-reaching policy reforms to bring the scheme back to full sustainability can be attempted. a number of key challenges have, however, been observed. first is differences in how mobile telecommunications companies present their ussd menu following the shortcode issued by the health insurance member to access the service. for example, whiles mtn has been adjudged simpler in terms of plugging in by the mobile platform aggregator and presenting a much simpler interface for approving payment out of health insurance members mobile wallet without leaving the screen, vodafone and airteltigo are said to have a complicated menu system. this process involves the health insurance member first generating a code called a voucher number. after the code is received, the health insurance member will have to dial another shortcode to complete the health insurance renewal process, resulting in two separate steps for the subscriber. even though the mobile telecommunications companies such as airteltigo claim the voucher system is more secure and clients more protected, this presents challenges for easy adoption by health insurance members. secondly, resulting from degraded network connectivity from the mobile telecommunications network, health insurance members have had to contend with trying multiple times before the transactions eventually get completed to renew their memberships. at other times, health insurance members have money deducted from their mobile wallet without a corresponding renewal of their membership. this has been attributed to integration challenges between the other platform partners such as the mobile aggregator, the mobile telecommunications provider, including the nhis where system handshakes are not completed. lastly, digital illiteracy, the inability to use and access digital information and tools have resulted in the situation where some health insurance members are unable to use the service and rely on third parties, including mobile money vendors with the unintended consequence of giving out their personal information. the findings of the case study present us with a number of interesting issues for analysis and discussion. based on the research question and institutional theory as a lens, this section discusses the regulative, normative and cultural-cognitive institutional enablers and constraints. enablers generally mediate the successful achievement of organisational goals whiles constraints makes an action difficult or impossible to act upon [ ] . the findings show that the initial objective of the national health insurance was to provide a digital platform to address service accessibility problems leading to increased enrolment towards meeting universal health coverage targets. international nongovernmental normative institution funded and drove the digital platform initiative. first, the normative health-seeking culture in the country supported the need for a digital platform that could facilitate expanded coverage and access to health service. this normative health-seeking behaviour is manifested in the increased utilisation of health services under national health insurance. for example, active membership has risen from million as at the end of to . million in . mobile renewals under the platform continue to account for about - % of total renewals recorded. as at the end of september , the cumulative (january to september) mobile renewals was , , . the total revenue generated from these renewals is ghs , , or approximately $ . million accounting for . % of total transactions (mobile & bms renewals and new registrations) and . % of all renewals (mobile and bms). again, as at the end of september , a total of , health providers are using the authentication module regularly. within the same period, a total of , , health care attendances have been validated digitally. as noted in the literature, despite the relatively high percentage of its gross domestic product (gdp) on health [ ] , universal health coverage remains a long way from being attained as a result of service accessibility problems [ ] . nevertheless, digital platforms offer several advantages for health seekers, health provider and payer [ ] . another normative institution that enabled the digital platform initiative was the penetration and use of mobile technology. mobile network penetration continues to surge in the country at %, as at [ ] meaning an estimated out of every ghanaian adults own a mobile phone. these include some of the over million currently active members of national health insurance. these normative factors encouraged the nhis to seek the development of digital platform capabilities that apart from facilitating access to health care also provides online payment services. normative use and growth of mobile banking and payment systems for economic transactions and exchange [ ] further ensured the integration of the payment system into the nhis digital platform. the outcome is a more efficient and transparent means of accounting for cash inflows to the scheme from premium payments. a regulative institution would ascertain whether the organisation is legally established and whether it is acting in accord with relevant laws and regulations. the research findings suggest that the principal regulative institution establishing the nhis is act that replaced act in october to consolidate the nhis. the objective of the revised law is to remove operational bottlenecks and drive transparency towards the attainment of universal health insurance coverage. the regulative pillar's legitimising influence supports and authorises individuals within the nhis to take specific actions, in this case, the development and implementation of a digital platform to boost membership registration in order to meet the united nations universal health coverage goals. the design and construction of digital artefacts and technologies are mandated by regulative authorities often in the interests of the larger society [ ] . digital platform has the potential for increased levels of health insurance member engagement, a model of participatory health care that could improve service outcomes while also lowering cost. however, normative constraints embedded in ussd interface across mobile telecommunications provider platforms poses challenges to continued adoption and use of the service platform. health insurance members experiencing challenges will revert to travelling to dmhis offices to renew their health insurance memberships defeating the goal of improving service experience using the platform. the extended family system, which is deeply embedded in the ghanaian culture is a group consisting of close kin organised around either patrilineal or matrilineal relatives or lines. the extended family system results from the communal rather than individualistic social network based on a fundamental need to care for other members of the extended family [ ] . this system typically includes a man, his wife, children or offspring in addition to other kin. by extension of this system, reverence is accorded family heads and community leaders. in practice, family heads can register for national health insurance membership on behalf of an entire household while community leaders do same for community members. in secondary schools, mass registration of students unto the national health insurance can be linked to a single phone number of a school head. within the nhis mobile authentication platform, when a member visits the health provider to access health care, the member after consultation receives a notification on their mobile device asking them to confirm whether they were at the health provider on a given day and time to access health care. this verification system is for purposes of enabling the nhis to link attendance to claims received from the health provider, many of which are fraudulently sent for payment. in most cases, these notifications are not responded to because the receiver has no knowledge of a visit to the health provider by an individual family member on whose behalf, he/she undertook the nhis member registration. this cultural-cognitive institution is a major constraint on the nhis ability to obtain proper feedback to validate claims received from health providers. this constraint goes to the heart of the schemes cost containment and financial sustainability drive. the purpose of this study was to understand how institutional effects enable or constrain digital platform development and use in national health insurance from a developing country context. by applying institutional theory to analyse digital platform in national health insurance, our work contributes to digital platform research in the health sector in general and health insurance in particular. the findings show that digital platform is a promising means to help health insurance organisations in developing countries to achieve national coverage. however, to derive the benefits, health insurance managers should pay attention to institutional enablers and constraints that affect digital platform development and use. the study contributes to research, practice and policy. for research, the study reveals regulative, normative, and cultural-cognitive enablers and constraints and how they can shape the development and use of digital platform for health insurance in a developing country context. by identifying these institutions, this study extends existing knowledge on digital platform development and access in developing countries. for practice, the study shows that health insurance managers should not only address technical issues related to digital platforms but also focus on social issues such as institutional enablers and constraints that affect digital platform development, use and outcomes. the findings offer practical lessons on how institutions can facilitate or promote successful deployment and use of digital platforms for national health insurance. for policy, the study calls on developing country governments to create the appropriate institutional environment and frameworks to support digital platform development and use for health insurance and the public sector in general. for future research, there is the possibility of uncovering other institutional enablers and constraints to enhance our understanding of digital platforms and their institutional environments. we encourage future research to explore how private health insurance develop and use digital platforms and the institutional factors that affect them. research commentary-the new organizing logic of digital innovation: an agenda for information systems research use and impact of ict on smes in oman innovating with enterprise systems and digital platforms: a contingent resource-based theory view organizational 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frailty in older adults: randomized control trial design and protocol. alzheimer's dement an empirical evaluation of cashless systems implementation in ghana households' ict access and bank patronage in west africa: empirical insights from burkina faso and ghana tracing the emergence and formation of small dot-corns in an emerging digital economy: an actor-network theory approach key: cord- -oy hsrpt authors: beutels, philippe p.a. title: economic aspects of vaccines and vaccination: a global perspective date: journal: the grand challenge for the future doi: . / - - - _ sha: doc_id: cord_uid: oy hsrpt nan a basic principle of economic decision-making is that in an environment of scarce resources choices have to be made in the allocation of these resources. this principle also applies to the provision of health care. the share of health-care expenditures in the gross domestic product (gdp) of most industrialised countries has increased from %- % in the early sixties to %- % in (from % to % in the usa) [ ] this rise has been attributed to medical advances (increasing the number and technological complexity of medical interventions), population aging, sociological changes (more, but smaller families and less familial support for the elderly) and insufficient productivity increases in the services sector. in less wealthy economies, medical decision-makers are faced with a smaller margin, and such a rise in health-care spending has not been observed yet. basically, the richer a country, the more it can afford (in nominal and in relative terms) to spend on health care. the two-way interaction between health and economic development is generally explained as follows. the healthier the population, the more adults can contribute to society by productive activity (i.e., work creating a surplus value in terms of capital gains and human resources), as well as by raising children in a stable environment, thus ensuring continued economic development. the process of economic development itself creates conditions (education, employment, infrastructure (including safe water and sanitation)), which provide a basis for continued improvement in longevity and health-related quality of life [ ] . individual good health can be seen as the product of some unknown complex function to which health care is only one of the inputs. other important inputs are: life-style variables (eating habits, smoking, etc.), environmental factors (urbanisation, climatic conditions, etc.), income, education and genetic predestination. furthermore, expenditures on health are not necessarily put to use in the most efficient economic aspects of vaccines and vaccination: a global perspective way. in this respect a distinction can be made between technical efficiency (providing maximal health care for a given cost, or delivering a certain service at minimal cost) and allocative efficiency (the distribution of resources across alternative services so as to maximise health gains, in accordance with preferences). finally, though much may be spent on health care, not all people may have equal access to health care of the same quality. indeed inequities in the consumption of health care may also interfere with the overall allocative efficiency of the system, and create inequities in health per se. therefore greater expenditures on health care are no guarantee for more global health. it should be noted that these observations do not plead for a reduction or containment of health-care budgets, but rather for a way of spending that ensures that societal goals are met. in order to achieve this, welfare economists focus research on two broad topics: efficiency and equity. efficiency relates to choosing options that maximise utility from marginal expenditures (i.e., by optimising the production process of health, for which health care is one of the inputs). equity relates to the fair distribution of all aspects related to health across members in society (e.g., equal access to care). clearly, there may exist a trade-off between efficiency and equity and giving priority to either of them is a normative issue that should be decided by social and political debate. vaccination is undoubtedly one of the major contributors to health improvements in the last three centuries. during this period, the impact of vaccination on longevity is undeniable, despite the fact that its partial contribution is difficult to distinguish from that of improved hygienic conditions and nutrition, and the discovery of penicillin [ , ] . all of these combined provided the basis for the so-called "epidemiological transition" in industrialised countries. at the same time, infectious diseases remain the main cause of death in many developing countries. despite the continuing expansion of the vaccine portfolio, implementing financially sustainable basic vaccination programs in poor countries remains problematic. though this is not so much an economic as a financial aspect, we will return to this issue in the section "financing vaccines". a number of peculiar characteristics set vaccination apart from other interventions in health care [ ] : ( ) since vaccination is (usually) a form of primary prevention, it intervenes in people (often children) who are generally in good health. but unlike most other prevention programs, the interven-tion itself can cause harm to the vaccine recipient, because in rare cases vaccine-associated adverse events (vaae) occur. this means that people make trade-offs between risks of vaccine-preventable disease and risks of vaae. the perception of these risks is quintessential to the individual demand for vaccines (if left to free-market mechanisms), and dominates the influence of other factors such as price [ ] . ( ) vaccination not only protects vaccine recipients, but it also reduces exposure of unvaccinated people, due to the reduced circulation of the infectious agent (if the transmission of infection occurs from human to human). this is not always beneficial for public health as the reduced risk of transmission leads to an increased average age at infection (with many "childhood" infections being more severe if contracted in adulthood) [ , ] . together with the first characteristic, this means that people generally have an interest in having everyone else vaccinated, but not themselves (or their children). ( ) a number of infections can be eradicated in the long run if vaccination efforts are sustained at sufficiently high coverage levels around the world. in other words, sometimes vaccination has the potential of making itself redundant. choices about eradication are closely linked to the welfare of future generations and societal time preference (see also below) [ , ] . since the perceptions outlined above are usually distorted by insufficient or biased information, government intervention (in the form of subsidies, or coercion) is desirable to ensure that vaccine uptake remains optimal. indeed, as uptake increases the risk of vaae remains constant, but individuals may perceive it to increase. at the same time the absence of vaccine-preventable disease may create a false sense of security, and lure people into believing that their risk of disease has reduced to zero as well, while this is highly dependent on historical and future rates of exposure and vaccination in the rest of the population. the vaccine market represents only . % of the global pharmaceutical market, but has high growth potential (estimated at - % per year by various sources, mainly due to new combination, new prophylactic and new therapeutic vaccines) [ ] . for a manufacturer, the contribution margins of vaccines are low compared to those of other products in both the developing and industrialised world (due to price and licensing regulations). the few suppliers of vaccines now aim to limit production to the projected global needs in any given year (unicef bought about % of "traditional" vaccine supply in , compared to about % in ). thus the market is very vulnerable to capacity problems: a problem with a single batch of vaccines by a single producer can have severe knock-on effects across the globe. this may also explain why, for some of the old vaccines, the price fluctuates, and has had the tendency to rise over the last years. close co-operation between demanders (governments or agencies) and suppliers is essential to ensure continued availability at the right time. vaccines are supplied under a tiered price system, with % of sales volume in developing countries and countries in transition, but % of sales revenue in industrialised countries [ ] . it is therefore not surprising that global vaccine manufacturers (with three big producers (glaxosmithkline, aventis and merck) occupying % of the global market) tend to focus on products for the industrialised world. it is to be expected that more combination vaccines will become available and existing combinations extended. examples of this include the hexavalent diphteria-tetanus-pertussis-inactivated polio virus -haemophilus influenza type b -hepatitis b (dtp-ipv-hib-hepb) vaccine, and the quadrivalent measles-mumps-rubella-varicella-zoster (mmrvz) vaccine. the research and development costs for these vaccines are high due to technical and regulatory complexity. the technicality, the multiple patents and requirements in terms of clinical trials (all demanding great time and money investments) increase barriers to enter the vaccine market. this may lead to more monopolistic behaviour, with risks to supply, choice and price. clearly, the benefits of combination vaccines are many. for instance, reductions in the number of injections and associated administration costs (including reduced money, time and pain costs for children and their parents), and reduced transmission by contaminated needles benefit recipients and the public health bodies. free-rider effects (important and not-soimportant vaccines can hook up with established vaccines, irrespective of how recipients perceive their importance) and economies of scope benefit manufacturers and perhaps public health bodies. these benefits will have to be traded off versus the higher price of combination vaccines. because governments, health insurers or agencies (unicef, paho) typically buy vaccines directly from producers, there is also little diversity on the demand side of the market. all of this implies that there is little competition on both sides of the market and that global societal goals (development and supply of affordable vaccines for poor countries as well as rich countries) are unlikely to be met by relying entirely on free-market mechanisms (particularly since these are hampered by (necessary) regulation with regards to quality control and licensing). by using economic evaluation we are essentially trying to answer the following questions [ ] : ) is the vaccination program under study worth doing compared to alternative ways of using the same resources? in other words: should the (health care) resources be spent on such a vaccination program, and not on something else? ) more specifically, if we are deciding to vaccinate against a particular disease, whom should we vaccinate, at which age, with which vaccine and how should the vaccine be delivered and administered in order to deploy our scarce resources in the most efficient way? most economic evaluations of vaccination are model-based, because the alternative, empirical analysis, is usually impractical, very time-consuming (for most vaccines it takes decades for the full effects to unfold), very expensive and potentially unethical. a complete economic evaluation should compare different options for an intervention, in terms of economic costs as well as health consequences. there may be several options to prevent an infectious disease, some of which are mutually exclusive, while others are complementary. the relevant costs and benefits need to be collected for each option, and calculated relative (incremental) to another option. the choice of the reference strategy against which the other options are evaluated can be highly influential for the results of the evaluation. unless it is a cost-ineffective strategy, current practice is the preferred strategy of reference. when a new vaccine is introduced, the reference strategy is often referred to as "doing nothing" (no vaccination), although in this case "doing nothing" usually means the treatment of cases as they arise, with the corresponding public health measures. a generalised distinction between the costs and benefits of vaccination is presented in table . the intervention costs dominate the cost side. these are the costs necessary to implement the vaccination program. additionally there are costs incurred to receive the vaccine. the benefits of vaccination are the gains in health and the avoided costs. direct costs can be avoided because less treatment is needed for curing or nursing the disease against which the vaccination program is aimed. additionally indirect costs can be avoided because vaccination may partly prevent people having to interrupt their normal activities in society because of their illness or the illness of their relatives. from the health-care payer's point of view, only direct medical costs need to be taken into account. however, from society's viewpoint, indirect non-medical costs are also relevant. other viewpoints can be those of patients, hospitals, travel clinics, insurance companies, employers, etc. (see fig. ). for each of these perspectives different costs and benefits may be relevant. this implies that it is possible for an intervention to be relatively cost-effective for one party involved, while it is not for another. different cost categories are listed in table . the listings in italics are often not taken into account, because they can be relatively small in comparison to the other costs and/or because they are difficult to estimate. sometimes their inclusion is not relevant to express the viewpoint of the analysis. however, if they are relevant for the viewpoint of the analysis, their impact on the results could be tested in a sensitivity analysis and their existence should be mentioned when the results are presented. some diseases affect expectations and behaviour beyond one degree of separation from the pathogen. for instance the global impact of the sars outbreak in was modest in disease burden ( probable cases, deaths) and associated health-care costs, but it had an impressive impact on the global economy (us$ - bn, or $ - m per case) in macro-economic terms (when the impact on consumption and investments are considered) [ , ] . a similar situation could arise for pandemic influenza, or any other disease that affects risk perceptions of consumers and investors (e.g., variant creutzfeld jacobs disease). however, for most currently vaccine-preventable diseases, micro-economic evaluation would provide an appropriate analytical framework, preferably adopting a societal perspective. in reality, decisions about universal vaccination are often taken from the perspective of the national health service (nhs) or the ministry of health and at best from the health-care payer's perspective (which in addition to the nhs costs also includes direct co-insurance and co-payments by the patient). indeed, decision-makers in health care tend to focus primarily on direct costs since these are most indicative of their immediate budgets, even if their decision has bearings on society at large. when it comes to estimating unit costs or prices, it should be noted that costs in an economic sense are opportunity costs: they represent a sacrifice of the next best alternative application [ ] . this entails that costs in an eco- philippe p.a. beutels health gains (physical and psychological) source: [ ] nomic sense are not necessarily the same as financial expenditures, and that they can also represent goods and services that are not expressed in monetary terms. however, market prices are often used as a proxy. if particular goods and services are not traded on a market, ("shadow -") prices of a similar activity can be used instead. for example, work of volunteers can be approximated by wages of unskilled labour. similarly, patients' leisure time could be based on average earnings or average overtime earnings. average costs per unit of output are the total costs of producing a quantity divided by that quantity. marginal costs constitute the additional costs of producing one additional unit of output. since decisions are made at the margin, marginal costs should be used where they are substantially different from average costs [ ] . for vaccination, this distinction is most relevant for estimating the costs of the program [ ] . the costs of adding a particular vaccine to the existing program depends on how well the schedule of the new vaccine fits in with the other schedules, whether specific precautions need to be taken, whether potential vaccinees need to be screened prior to vaccination or whether a specific target group is envisaged. the costs that are most heavily affected by adding a new vaccine to the existing program are the variable costs of the program (time spent per vaccinee, number of vaccines bought, etc.), whereas the influence on the fixed intervention costs (buildings, general equipment, etc.) is usually small (unless a new vaccine requires a substantially different infrastructure in terms of storage and transport). a good example of this is provided by hall et al. who examined the immunisation program in the gambia (more recently these results were confirmed by a similar analysis in addis ababa, ethiopia) [ , ] . they found that the additional costs of adding hepatitis b vaccine to the existing expanded program on immunisation (epi) vaccines (measles, polio, dtp and bacille calmette-guérin (bcg)), would be for % recurrent costs (of which % for purchasing hepatitis b vaccine (hepb)). still, the introduction of a new expensive vaccine could more than double the costs of the program in some countries because of its sheer price compared to other vaccines in the program. the main objective of vaccination is to prevent disease. the most important benefits from a public health point of view are therefore the health gains (see tab. ). these are both physical (avoiding illness, suffering, mortality, etc.), and psychological (avoiding distress, anxiety, etc.). specific vaccinerelated psychological health gains include the general feeling of well-being and security of vaccine recipients from knowing that they are protected against disease. this could evidently lead to behavioural changes (e.g., a vaccine against hiv/aids could have a large influence upon the sexual behaviour of vaccine recipients). the valuation of health outcomes has far-reaching consequences for the methodology and study design of applied analyses. generally, a distinction is made between four different methods, depending on the way in which health gains are measured [ ] . a cost-minimisation analysis compares the costs of equally effective alternatives, without quantifying the health gains. it differs from a pure cost philippe p.a. beutels source: [ ] analysis in that there is always more than one option analysed and that the effectiveness of the different alternatives is known to be equal. in a cost-effectiveness analysis, health gains are measured in one-dimensional natural units (e.g., infections prevented, hospitalisations prevented, deaths averted, life-years gained…), implying that only one aspect of effectiveness is considered (e.g., postponing the time of death) and other related aspects are not (e.g., the quality of life). the results of cost-effectiveness analyses (cea) are usually presented as a ratio. a cost-effectiveness ratio (cer) is a measure of the incremental costs, which are necessary to obtain one unit of a health gain by implementing a strategy j instead of a strategy i (expressed in incremental costs per life-year gained, incremental costs per infection prevented, etc.). the lower the ratio, the more efficiently strategy j gains health compared to strategy i. the units in which health gains are expressed should represent the final results or clinical endpoints of an intervention as adequately as possible, in order to enable comparison between different interventions [ ] . if, hypothetically, the cost-effectiveness of hepatitis b vaccination were $ per infection prevented, whereas hib vaccination is estimated at $ , per infection prevented, it is wrong to conclude that hepatitis b vaccination is more cost-effective (because it is less costly to prevent one infection). to make that judgement, the avoided effects would need to be expressed in a more comparable endpoint, like life-years saved. to make the comparison even more relevant, different health states should be weighed by their quality (scaled from (meaning death) to (meaning perfect health)). this approach is used in cost-utility analysis (cua), where health gains are measured in quality-adjusted life-years (qalys) saved or another combined measure of morbidity and mortality (e.g., disability-adjusted life-years (daly)). a cost-utility ratio (cur) is similar to a cer, except that the denominator contains the difference in qalys (or dalys), instead of the difference in natural units, such as cases avoided or life-years gained. the main advantage of cua over cea is that it allows comparison of very different health-care interventions, for instance, those that predominantly extend lives (e.g., flu vaccination of the elderly) with those that improve the quality of life (e.g., drugs against erectile dysfunction). in cost-benefit analysis (cba), the health gains are converted into monetary units, which, in theory, allows the many dimensions that are associated with an improvement in health status (over and above the length and health-related quality of life) to be included. there are benefits beyond the health outcomes such as information, caring, regret, anxiety reduction, communication and process utility (benefits from health-care use). further-more, option value (i.e., benefits derived from needing care in the future) and non-use value (i.e., externalities related to caring for the health of others) can also be (potentially) elicited [ ] . the results of a cba can be presented as the difference between costs and benefits (the net costs (or net savings)) or as a ratio. the benefit-cost ratio (bcr) expresses to which extent an investment in an intervention can be recovered by the consequences of that intervention (expressed as a unitless number or a %). cost-benefit analysis allows for comparisons between totally different projects in society (e.g., comparing a vaccination campaign with the construction of a new bridge). when budgets are very limited and many urgent interventions compete, as in developing countries, such cross-sector comparisons may actually be used in practice. clearly, the potential of cba to make such comparisons possible is a major advantage to aid decision-making. the strength of cba in theory, i.e., the explicit monetary valuation of health gains, has up till now been also its weakness in practical decisionmaking. in theory it seems preferable that the valuation of health gains (and of life) is done in an explicit, transparent and representative way as in cba, instead of the implicit, inconsistent and arbitrary way it is often done in today's decision-making. however, in a health-care environment the monetary valuation of health (and particularly of life) is often rejected on an emotional basis [ ] . additionally, economists have few credible arguments to counter these objections, as the current methods which place a monetary value on health (human-capital and willingness-to-pay methods) can hardly be called consistent and reliable in practice [ ] [ ] [ ] . in view of this, most economic evaluations in health care are based on cea or cua. the literature on these has increased exponentially since the s, for vaccines at least as much as for other interventions in health care, underlining the importance of a sound theoretical framework for these analyses [ ] . individuals (and societies), in general, prefer to receive benefits as early as possible and incur costs as late as possible. this so-called time preference means that the same amount of wealth or health would have a different value to a decision-maker in the present, if this amount is gained at different points in time. note that time preference has nothing to do with inflation. a vaccination program is an investment made in the present (i.e., the costs of buying and administering vaccines) to gain benefits spread out over the future (i.e., avoided costs of treatment, avoided morbidity and mortali-ty). discounting is a technique by which future events (e.g., costs and health outcomes) are valued less the further in the future they arise. the degree to which they are valued less is determined by the discount rate (frequently assumed to be constant through time): the higher the rate the less future benefits and costs are valued. although there is general agreement on the discounting of costs, the arguments for discounting non-monetised health outcomes are contradictory [ ] . discounting costs without discounting benefits leads, amongst others, to the paradoxical situation that any eradication program will yield infinite benefits [ ] . this would imply that all current resources should be spent on research of eradicable diseases, and the implementation of eradication programs, and not a single penny on cure. such paradoxes, and the observation that individuals generally have a positive discount rate for health, clearly indicates that health too should be discounted at a positive rate. but there is no general agreement on how the discount rate for health should compare to that of wealth. there are arguments to apply an equal discount rate to both costs and health effects [ , ] . the underpinnings and relevance of these are questionable, so that a lower discount rate for health effects than for costs has also been proposed [ , ] . because of the very long time spans over which benefits accrue, the analysis of most vaccination programs is very sensitive to discounting (of costs as well as health effects). nonetheless, this is no cause for a different approach to discounting for vaccination. still, further empirical research is needed to strengthen or to change the basis for conventional discount rates (mostly %, or %) and discount models (mostly stationary) [ ] . a slight decrease in discount rate (from, say, % to %) could change the cost-effectiveness of some vaccination programs from unattractive to attractive. also, it is likely that time preference in developing countries is substantially different (i.e., higher) from that in industrialised countries, particularly for those countries that have decreasing health (e.g., life-expectancy due to hiv/aids) or wealth (e.g., real gdp) expectations [ ] . in theory, decisions are made by interpreting the results of economic evaluation as follows. in figure a new program is plotted in terms of costs and effectiveness versus the reference strategy in the origin. if the new program is less costly and more effective than the reference, then the new program (a "dominant" strategy) should be implemented. likewise, if the new program is more costly and less effective than the reference, it should be rejected. in the other quadrants the decision is more complex, because it depends on a value judgement. if the incremental cer (or cur) is smaller than a given willingness to pay (or threshold cost-effectiveness criterion), "k", it would be acceptable. the question then is, how to determine k? this could be determined by social debate or by comparing it to what is widely accept-ed in practice. the most widely cited k in industrialised countries is $ , per qaly gained. there may also be a grey zone for k in which some interventions are implemented and others are not (e.g., between $ , per qaly gained and $ , per qaly gained), whereas under and above that grey zone all and none of the interventions are implemented, respectively. however, the greater the analytical uncertainty and the burden of disease, the more decisions are likely to deviate from such clear cut-off practices [ ] . different societies should have a different willingness to pay, though there are few instances in which societies (or their decision-makers) have tried to determine what the appropriate value of k is. the world bank has suggested using gnp per capita as a benchmark for k. note that in cba, k has already been given an explicit value. in league tables, many vaccination programs rank with the most costeffective interventions in health care in industrialised countries [ , [ ] [ ] [ ] . it is tempting to try and estimate the global historical value of vaccination. however, due to scarcity of data in most parts of the world such an exercise philippe p.a. beutels figure . the cost-effectiveness plane. cer: cost-effectiveness ratio, i.e., incremental costs divided by incremental effects; k = willingness to pay, or a cost-effectiveness ratio of acceptable magnitude. all points on a line in this plane have identical cost-effectiveness ratios. would be, by necessity, extremely crude. it seems clear, though, that the smallpox eradication program and the establishment of the epi have generated enormous benefits, not only by directly protecting against important vaccine-preventable diseases, but also by providing opportunities for health education and infrastructure in developing countries [ ] . yet the associated disease reduction in smallpox, measles and tetanus alone is bound to have been a cost-saving enterprise around the world (i.e., in the lower right quadrant of fig. ) , currently averting over million deaths per annum, compared to a "never having vaccinations" situation. however, when we are making choices today, we have to consider what additional benefits we will achieve by making additional investments, and this is bound to vary between countries at different stages of economic development, different epidemiologies of disease, and different historical vaccine-uptake levels. hence data from one country cannot always be simply extrapolated to another. in practice, there are many factors that come into play when decisions are made about new health-care interventions (see fig. ). in a democracy, a decision-maker receives a temporary, renewable mandate from the public to allocate a given budget. that person is well aware of the public perceptions of public health problems, and the impact of decisions thereon. at the same time, pressure groups may try to influence decision-makers or the public's perception. these pressure groups have vested interests in the decisions (be it as sellers of vaccines, or sellers of services for the cure of vaccine-preventable diseases). societal goals with regards to the decision can only be met by considering its medical, social, ethical and cost implications. the theoretical foundation of economic evaluation (so-called "pareto opti- figure . factors influencing decision-making in practice mality") addresses efficiency, without concern for distributional aspects (equity). therefore, economic evaluation combines the medical/epidemiological and cost implications, but does not consider the social and ethical implications depicted in figure (though in cba these aspects could theoretically be included, if a willingness-to-pay approach is used, and it is possible to weight quality-of-life gains to help achieve equity goals, as is commonly performed in dalys). therefore economic evaluation should be seen as an additional type of analysis that cannot stand on its own in its current form (it is an aid to decision-making, not a decision-maker in itself). at the same time, ideally, the influence of pressure groups, and the public's perceptions (rather than the public's true preferences) should be minimised in this process. it is noteworthy that most vaccination programs are likely to be equitable according to prevailing theories of justice [ ] . indeed, an analysis for bangladesh indicated that socio-economic inequalities in mortality of under- -year-olds were eliminated by measles vaccination [ ] . in the past, vaccination interests of poor and wealthy nations seemed more in tune than today. moreover, the research and development costs of the new generation of vaccines, based on biotechnology, are greater and the regulatory hurdles higher, meaning that new vaccines are much more expensive than the basic package of "traditional" vaccines. the first new expensive vaccine for global use was the hepatitis b vaccine, which became available in . the main reason why it was not immediately included in universal vaccination programs was its price, because initially the hepatitis b vaccine cost more than the other six epi vaccines put together. with the advent of more expensive vaccines, the introduction of a new vaccine is not as straightforward as it used to be in the industrialised world. in contrast to some of the "older" vaccines (e.g., measles, pertussis), newer vaccines may not result in net savings to the health-care system. nonetheless, if considered desirable, industrialised countries have no difficulty in financing the introduction of new vaccines, and ensuring the continuing uptake of old ones. for developing countries, the main difficulty is not so much to determine whether it would be cost-effective to introduce a vaccine, but to ensure that the introduction is financially sustainable. when external donors sponsor vaccination programs the sustainability takes the form of a partnership with shared responsibility and the promise by the receiver of the financing to create the conditions to become self-sufficient in the long run, either alone or by attracting further external funding. global immunisation efforts came under pressure as the epi, which was launched in the s as a way of building on the success of the smallpox eradication program, lost its momentum in the s, and failed to attain the year goal of % global vaccination coverage. indeed, global child-hood immunisation coverage against the six main target diseases (polio, dtp, measles and tuberculosis), which was less than % in , decreased from about % in to % in [ ] . coverage for the complete schedule of dtp remains well below % in tens of developing countries, mostly in sub-saharan africa. these countries are traditionally bottlenecks in the epi because of great financial constraints, the evolution of the hiv epidemic, logistical difficulties, poor governance and general socio-economic conditions (sometimes aggravated by war). as these factors evolved unfavourably in the s, international alliances shifted their efforts from reducing general global inequalities in health ("health for all") to more selective strategies, like the polio eradication program and the introduction of new and improved vaccines. the discrepancy between the developing and the industrialised world is likely to become greater, as private vaccine development focuses primarily on diseases that affect the wealthy. indeed, only about % of world drug sales is for african countries. it has been estimated that of all expenditures on health research (over $ billion per year), % is for diseases that affect % of the world's population [ ] . using recent examples, kaddar et al. assert that financing vaccination should be affordable by all countries, at least for the basic vaccines [ ] . the cost of fully immunizing a child with the basic vaccines is $ to $ , which typically represents % to % of public health expenditures, <$ . per capita or about . % of gdp. most vaccination costs are fixed costs of personnel and infrastructure, and the marginal costs of an additional vaccine may often be bearable for the domestic budget (though still highly dependent on vaccine price). as the th century drew to a close, the landscape of external vaccine financing underwent dramatic changes with the inception of the global alliance for vaccines and immunization (gavi) and the vaccine fund, with the aims to stimulate research and development for developing world problems, strengthen immunization systems, and promote and support the introduction of new and underused vaccines. gavi is an alliance of financiers (development banks, aid agencies, foundations), agencies (unicef, who), vaccine developers and manufacturers, as well as developing country governments, whereas the vaccine fund manages private financial resources, such as those from the bill &melinda gates foundation, and public contributions from a small number of wealthy countries. the first generation of vaccines, such as measles and oral polio vaccines, was used against common and serious childhood diseases afflicting all countries in the world. few of these vaccination programs were subject to economic analysis before introduction, and for good reason: the benefits were obvious and the costs low. indeed, they were probably amongst the most effective and cost-effective public health programs of the th century. this is no longer necessarily the case with new vaccine introductions. new vaccines are generally higher priced and unlikely to fall in price to the level of the first generation of vaccines. furthermore, they are often aimed at less common or less serious diseases (particularly in the industrialised world). thus, whether these vaccines are worth introducing is less clear. vaccine financing has recently changed with important initiatives stimulating development and use of vaccines for the developing world. these are to be welcomed as they may further alleviate the disease burden in developing countries at affordable cost, correct market imperfections with regard to research and development, and reduce inequalities in health. nonetheless, the introduction of new vaccines demands cautious planning. if it comes at the expense of the uptake of the first generation of vaccines, it may have a detrimental influence on the effectiveness and cost-effectiveness of the whole program. in view of all these developments, the role of economic evaluation in vaccine program design is only likely to increase in the future. world development indicators, online publication available on cd rom commission on macroeconomics and health: investing in health for economic development the conquest of smallpox an interpretation of the modern rise of population in europe economic evaluation of vaccination programmes in humans: a methodological exploration with applications to hepatitis b, varicella-zoster, measles, pertussis, hepatitis a and pneumococcal vaccination economic epidemiology and infectious disease infectious diseases of humans -dynamics and control increase in congenital rubella occurrence after immunisation in greece: retrospective survey and systematic review economics of eradication vs control of infectious diseases lecture at the advanced course in vaccinology, international vaccine institute assessing the economic impact of communicable disease outbreaks: the case of sars globalization and disease: the case of sars methods for the economic evaluation of health care programmes the cost of integrating hepatitis b virus vaccine into national immunization programmes: a case study from addis ababa cost-effectiveness of hepatitis b vaccine in the gambia providing health care. the economics of alternative systems of finance and delivery methodological issues and new developments in the economic evaluation of vaccines the economics of health and medicine estimating costs in costeffectiveness analysis evaluation of life and limb: a theoretical approach theory versus practice: a review of "willingness to pay" in health and health care discounting of life saving and other non-monetary effects foundations of cost-effectiveness analysis for health and medical practices discounting costs and effects: a reconsideration discounting for health effects in cost-benefit and cost-effectiveness analysis does nice have a cost-effectiveness threshold and what other factors influence its decisions? a binary choice analysis cost-effectiveness analysis and the consistency of decision making: evidence from pharmaceutical reimbursement in australia a comprehensive league table of cost-utility ratios and a sub-table of "panel-worthy" studies fivehundred life-saving interventions and their cost-effectiveness the societal value of vaccination in developing countries measles vaccination improves the equity of health outcomes: evidence from bangladesh the state of the world's children. early childhood the / gap report financial challenges of immunization: a look at gavi the author is grateful to dr john edmunds (health protection agency, uk) for constructive comments on an earlier version, and to the flemish fund for scientific research (fwo g. . ) and the european union funded project polymod (eu fp ) for financial support. key: cord- -azrqz hf authors: ganasegeran, kurubaran; abdulrahman, surajudeen abiola title: artificial intelligence applications in tracking health behaviors during disease epidemics date: - - journal: human behaviour analysis using intelligent systems doi: . / - - - - _ sha: doc_id: cord_uid: azrqz hf the threat of emerging and re-emerging infectious diseases to global population health remains significantly enormous, and the pandemic preparedness capabilities necessary to confront such threats must be of greater potency. artificial intelligence (ai) offers new hope in not only effectively pre-empting, preventing and combating the threats of infectious disease epidemics, but also facilitating the understanding of health-seeking behaviors and public emotions during epidemics. from a systems-thinking perspective, and in today’s world of seamless boundaries and global interconnectivity, ai offers enormous potential for public health practitioners and policy makers to revolutionize healthcare and population health through focussed, context-specific interventions that promote cost-savings on therapeutic care, expand access to health information and services, and enhance individual responsibility for their health and well-being. this chapter systematically appraises the dawn of ai technology towards empowering population health to combat the rise of infectious disease epidemics. infectious diseases disrespect national and international borders. they pose substantial threats and serious repercussions to global public health security. while the asia-pacific region was generally regarded as the main epicenter of emerging infectious diseases, with outbreaks of avian flu, asian flu and severe acute respiratory syndrome (sars) [ ] , the recent and unexpected emergence of zika pandemic spurred global concerns about pandemic preparedness capabilities particularly as it relates to training and deployment of healthcare workforce at a massive level, worldwide. despite coordinated global efforts, containing the "red alert" pandemic of zika remained a challenge, as both healthcare workers and public health advocates were uncertain about such disastrous contagion causing serious complications including congenital microcephaly in newborns and neurological deficits in adults [ , ] . control measures were obtunded as public health advocates were initially speculative about the potential transmission route of zika, while clinicians in hospitals were irresolute, instituting multiple levels of care and management to tackle the complications of zika. this debacle gave rise to an urgent need to debate the circumstances under which the zika epidemic has challenged human intelligence behavior and capacity to battle the threat effectively and efficiently. as population explosions and uncontrolled human mobility across nations catalyzes rapid disease propagation, our next question is, what else above human intelligence could help resolve such unprecedented epidemic crisis? scientists believe that the time has come to institute analytic technologies-such as artificial intelligence (ai)-in healthcare to help prevent and resolve such large disease epidemics [ , ] . adaptive ai applications could mould human behavior to practice preventive behaviors and disease control strategies [ ] , thereby improving global health. this chapter will systematically discuss the dawn of ai technology in healthcare that could potentially empower the human population to tackle unprecedented infectious disease epidemics. the human population has witnessed four major revolutions till date (fig. ) ; the foremost being the first industrial revolution that introduced steam engine to the world [ ] . this was followed by the second industrial revolution that introduced electrical-energy based productions. the first information revolution was conceptualized during the third industrial revolution in the late th century. it was during this time that computers and internet-based knowledge began and has since then shaped human interactions. in early st century, the fourth industrial revolution accelerated the second information revolution. the entire phase of human daily functions transformed with the debut of ai, bringing together massive information flow from different specialties. these culminated in the rise of big data with systems integration across the internet of things (iot) and cloud computing systems. current revolutionary era is based on extreme automation for global connectivity, in which ai would definitely play an imperative role as a resource to utilize. at the peak of emergent multi-function contexts of ai and the rise of big data analytics, the united nations (un) in unified global experts to galvanize a dynamic consensus on the adoption and expansion of ai use in delivering good public care services [ ] . succinctly, various stakeholders were assembled together in another un meeting to assess the role of ai towards achieving sustainable developmental goals (sdgs) [ ] . from the healthcare perspective, massive data have been obtained from public health surveillance efforts with the advancement of ai. one major public health field that gained momentum to develop various ai applications for disease prevention was the infectious disease domain [ ] . the human population is currently able to access potentially useful massive data sources of infectious disease spread through sentinel reporting systems, national surveillance systems (usually operated by national or regional disease centers such as the center for disease control (cdc)), genome databases, internet search queries (also called infodemiology and infoveillance studies) [ ] [ ] [ ] , twitter data analysis [ , ] , outbreak investigation reports, transportation dynamics [ ] , vaccine reports [ ] and human dynamics information [ ] . with the influx of massive data volume, effective data integration, management and knowledge extraction systems are required [ ] . epidemic modeling and disease-spread simulations form new horizons to understand the effects of citizen behaviors or government health policy measures [ ] . a simple integrated effect of disease knowledge discovery is exhibited in fig. . as humans, we are able to perform simple essential tasks such as object detection, visual interpretation and speech recognition. our interpretation is instantaneous when we look at an object or image, or when we hear voices or noises surrounding us. our next question is-could ai perform these essential intellectual tasks as well? the answer is absolutely yes, but in a different mode of function. while human interpretation is solely dependent on cognitive functions, ai requires mathematical algorithms to automate machines for execution of such functions [ ] . machines here refer to programmable computers! an example is to visualize the cause of an outbreak; dengue, chikungunya or zika, of which these diseases are commonly caused by the vector mosquito. in massive epidemics, elimination of the vector is important, and human cognitive functions can never detect all mosquitos in an outbreak investigation area! however, this can be easily detected through deployment of ai in areas which have loads of mosquito vectors to facilitate control measures. figure exhibits how human and ai technology interpret the vector differently. while human interpretation is instantaneous, ai evaluates the same image as humans do, but translated into codes [ ] , facilitating massive detection. while ai aims to mimic human cognitive functions, it lacks intuitive behaviors. scientists postulate that such synthetic intelligence which could be on par with human intelligence can be called "computational intelligence." however, the primary goal [ ] of ai was to create a system programming that is capable to think and act rationally like humans, although such machines may lack intuitive or emotional capabilities. as such, ai has been appropriately defined in simple and straightforward terms, as "a branch of computer science that deals with simulation of intelligent behaviors as humans using computers [ ] ". in principle, there are three types of ai. if a machine is able to think as humans do and perform a task similar to human intellectual capabilities, then that machine functionality is referred to as artificial general intelligence [ ] . if a machine performs a single task extremely well, this is known as artificial narrow intelligence [ ] . if the same machine out-smart the best humans in all fields from scientific creativity to general wisdom or social skills, this is referred to as artificial super intelligence [ ] . at present, virtually all contemporary ai application systems utilize artificial narrow intelligence. there are numerous concepts to function underlying ai applications in healthcare. based on the required functions, these concepts are clumped together to automate a single application-such as tracking infectious disease health seeking behavior. the following sub-sections summarize key concepts of different ai subsets adopted in emerging literature of infectious diseases. machine learning (ml). ml is a subfield of ai that implies learning from previous experiences (fig. ) . the system finds solution to a problem by extracting fig. interpreting the vector from the human and ai perspective. source da silva motta et al. [ ] previous relevant data, learn from this data and predicts new outcomes [ ] . ml applications are sub-divided into three categories: i. supervised learning: uses patterns of identified data (e.g. training data) ii. unsupervised learning: finds and learns from patterns of data (e.g. data-mining that involves identification of patterns in large datasets) iii. reinforcement learning: an extension of supervised learning that "rewards" and "punishes" when an application interacts with the environment. table illustrates some common examples of supervised and unsupervised ml methods that are currently adopted and utilized to track health seeking behaviors during infectious disease epidemics [ ] . deep learning (dl). dl is a specific subset of ml that uses neural networks (fig. ) . in short, it is basically a synthetic replica of the human brain structure and functionality [ ] . dl can execute multiple functions like image recognition and natural language processing (nlp). the system is capable of handling large datasets of information flow. image recognition. ai has the capability to process large amount of data about characteristics of a particular phenomenon in the form of images or signals [ ] . motion images and sounds are examples of signals that could be analyzed using artificial neural networks (anns) [ ] . recently, researchers from the usa proposed a system that could rapidly identify potential arbovirus outbreaks (mosquito, ticks or other arthropod borne viruses) [ ] . the system identifies images of mosquito larvae captured and delivered by a group of citizen scientists. not only did the developed prototype facilitate collection of images, it also facilitated training of image classifiers for the recognition of a particular specimen. this sets a base for execution of expert validation process and data analytics. it was found that recognition of specimen in images provided by citizen scientists was useful to generate visualizations of susceptible geographical regions of arboviruses threat (fig. ) . the system was capable of identifying mosquito larvae with great accuracy. the rapid identification of potential outbreak to a susceptible community could alert preventive behaviors and policy drafting in the quest to control potential epidemics. natural language processing (nlp). nlp bridges the gap between languages that humans and machines use to operate. algorithms are built to allow machines to identify keywords and phrases in an unstructured written text. ai applications then interpret the meaning of these texts for actionable knowledge [ ] . expert systems (es). es incorporates expert-level competence to resolve a particular problem [ ] . the system is constituted of two main components, namely knowledge base and a reasoning engine. it solves complex problems through reasoning a set of incomplete or uncertain information through a series of complex rules. in recent years, fuzzy logic, a set of mathematical principles for knowledge representation was crafted to accelerate the evolution of es. such strategy was utilized by a team of researchers from south africa to improve predictions of cholera outbreaks [ ] . public reaction and behavior towards disease outbreaks could be difficult to predict. with the rise of big data analytics and a pool of ai applications in place, public health researchers were able to correlate population's behavior during an outbreak [ ] . the following examples illustrate real life applications of ai during disease epidemics: twitter, a free social-networking micro-blogging service has enabled loads of users to send and read each other's "tweets (short, -character messages)." as important information and geo-political events are embedded within the twitter stream, researchers now postulate that twitter users' reactions may be useful for tracking and forecasting behavior during disease epidemics. the zika pandemic. most of the world's populations are living in endemic areas for common mosquito-borne diseases. the zika pandemic between the years of and marked the largest known outbreak, reaching a "red-alert" warning of multiple complications requiring global public health interventions. in such exigencies, population health behaviors are important for potential control measures. daughton and paul postulated that internet data has been effective to track human health seeking behaviors during disease outbreaks [ ] . they used twitter data between and respectively to identify and describe self-disclosures of an individual's behavior change during disease spread. they combined keyword filtering and ml classifications to identify first-person reactions to zika. a total of , english tweets were analyzed. keywords include "travel," "travelling intentions," and "cancellations." individual demographic characteristics, users' networking and linguistic patterns were compared with controls. the study found variations between individual characteristics, users' social network attributes and language styles in twitter users. these users changed or considered to change their travel behaviors in response to zika. significant differences were observed between geographic areas in the usa, with higher discussion among women than men and some differences in levels of exposure to zika-related information. this finding concludes that applying ai concepts could contribute to better understanding on how public perceives and reacts towards the risks of infectious disease outbreak. the influenza a h n pandemic. signorini and colleagues in analyzed twitter embedded data for tracking rapid evolvement of public concerns with respect to h n or swine flu, while concurrently measuring actual disease activity [ ] . the researchers explored public concerns by collecting tweets using pre-specified search terms related to h n activity with additional keywords related to disease transmission, disease countermeasures and food consumption within the united states. they utilized influenza-like illness surveillance data and predicted an estimation model using supervised learning method in machine learning. the results showed that twitter was useful to measure public interest or concern about health-related events associated with h n . these include an observed periodical spikes related to user twitter activity that were linked to preventive measures (hand-hygiene practices and usage of masks), travel and food consumption behaviors, drug related tweets about specific anti-viral and vaccine uptake. they concluded that twitter accurately estimated influenza outbreak through ai applications [ ] . the integration of internet data into public health informatics has been regarded as a powerful tool to explore real-time human health-seeking behaviors during disease epidemics. one such popular tool widely utilized is google trends, an open tool that provides traffic information regarding trends, patterns and variations of online interests using user-specified keywords and topics over time [ ] . such adaptations formed two conceptualizations: the first was "infodemiology," defined as "the science of distribution and determinants of information in an electronic medium, specifically the internet, or in a population, with the ultimate aim to inform public health and public policy [ ] ;" the second was "infoveillance," defined as "the longitudinal tracking of infodemiology metrics for surveillance and trend analysis [ ] ." examining health-behavior patterns during dengue outbreaks. dengue is highly endemic across the south-east asian countries. recently, a group of researchers from the philippines conducted an infodemiology and infoveillance study by using spatio-temporal concepts to explore relationships of weekly google dengue trends (gdt) data from the internet and dengue incidence data from manila city between and [ ] . they subsequently examined health-seeking behaviors using dengue-related search queries from the population. their findings suggested that weekly temporal gdt patterns were nearly similar to weekly dengue incidence reports. themes retrieved from dengue-related search queries include: "dengue," "symptoms and signs of dengue," "treatment and prevention of dengue," "mosquito," and "other diseases." most search queries were directed towards manifestations of dengue. the researchers concluded that gdt is a useful component to complement conventional disease surveillance methods. this concept could assists towards identifying dengue hotspots to facilitate appropriate and timely public health decisions and preventive strategies [ ] . health-seeking behavior of ebola outbreak. an unprecedented ebola contagion that plagued most west african countries in marked the rise of global public health interest in pandemic preparedness interventions. millions of ebola-related internet hit searches were retrieved. with such high fluxes of health-seeking behavior using computers, a group of italian researchers' evaluated google trends search queries for terms related to "ebola" outbreak at the global level and across countries where primary cases of ebola were reported [ ] . the researchers subsequently explored correlations between overall and weekly web hit searches of terms in relation to the total number and weekly new cases of ebola incidence. the highest search volumes that generated ebola related queries were captured across the west african countries, mainly affected by the ebola epidemic. web searches were concentrated across state capitals. however, in western countries, the distribution of web searches remained fixed across national territories. correlations between the total number of new weekly cases of ebola and the weekly google trends index varied from weak to moderate among the african countries afflicted by ebola. correlations between the total number of ebola cases registered in all countries and the google trends index was relatively high. the researchers concluded that google trends data strongly correlated with global epidemiological data. global agencies could utilize such information to correctly identify outbreaks, and craft appropriate actionable interventions for disease prevention urgently [ ] . public reactions toward chikungunya outbreaks. the italian outbreak of chikungunya posed substantial public health concerns, catalyzing public interests in terms of internet searches and social media interactions. a group of researchers were determined to investigate chikungunya-related digital health-seeking behaviors, and subsequently explored probable associations between epidemiological data and internet traffic sources [ ] . public reactions from italy toward chikungunya outbreaks were mined from google trends, google news, twitter traffics, wikipedia visits and edits, and pubmed articles to yield a structural equation model. the relationships between overall chikungunya cases, as well as autochthonous cases and tweet productions were mediated by chikungunya-related web searches. but in the allochthonous case model, tweet productions were not significantly mediated by epidemiological figures, instead, web searches posed significant mediating tweets. inconsistent associations were detected in mediation models involving wikipedia usage. the effects between news consumption and tweets production were suppressed in this regard. subsequently, inconsistent mediation effects were found between wikipedia usage and tweets production, with web searches as a mediator. after adjustment of internet penetration index, similar findings were retrieved with the adjusted model showing relationship between google news and twitter to be partially mediated by wikipedia usage. the link between wikipedia usage and pubmed/medline was fully mediated by google news, and differed from the unadjusted model. the researchers found significant public reactions to the chikungunya outbreak. they concluded that health authorities could be made aware immediately of such phenomenon with the aid of new technologies for collecting public concerns, disseminating awareness and avoiding misleading information [ ] . expert systems are built upon the basis to act as a diagnostic tool to accelerate detection of infectious disease epidemics, determining the intensity or concentration of vector-agents within the triads of infectious disease dynamics. the malaria control strategy using expert systems. malaria constitutes a "red-alert" health threat to the african communities. a group of researchers from nigeria built an expert system for malaria environmental diagnosis with the aim of providing a decisional support tool for researchers and health policy-makers [ ] . as prevailing malaria control measures were deemed insufficient, this group of researchers developed a prototype that constituted components of "knowledge," "applications," "system database," "user graphics interface," and "user components." the user component utilized java, while the application component used java expert system shell (jess) and the java ide of netbeans. the database component used sql server. the system was able to act as a diagnostic tool to determine the intensity of malarial parasites in designated geographical areas across africa. the proposed prototype proved useful and cost-effective in curbing malaria spread [ ] . whereas ai is gaining increasing popularity and acceptance as a quick fix to the myriad of challenges faced with pandemic preparedness using traditional population-based approaches, it is not without its own limitations. even in resource-rich settings, there are challenges associated with building and updating the knowledge base of expert systems [ ] , providing high-quality datasets upon which machine learning algorithms can be premised, and ethical issues associated with data ownership and management [ ] . additionally, resource-limited settings are further plagued with constraints of poorly organized and integrated health systems, poor it and communication infrastructure, and socio-economic and cultural contexts [ , ] that significantly impact successful implementation of ai systems. beyond these, the dynamics of human behavior and other environmental covariates (such as mass/social media, public emotions, public policy etc.) may not only influence the accuracy of epidemic disease modeling frameworks but also impact health seeking behavior during epidemics [ ] . more than ever before, public health experts, it developers and other stakeholders must work together to address concerns related to scalability of ai for healthcare, data integration and interoperability, security, privacy and ethics of aggregated digital data. finally, the transparency of predictive ai algorithms have been called to question, particularly given their 'black box' nature which makes them prone to biases in settings of significant inequalities [ ] . perhaps, it may be premature to describe ai as the future of healthcare given it is still in its infancy, however, it has become increasingly difficult to not acknowledge the substantial contributions of ai systems to the field of public health medicine. notwithstanding current challenges with the widespread adoption of ai particularly in resource-limited settings, the use of ai in providing in-depth knowledge on individuals' health, predicting population health risks and improving pandemic preparedness capabilities is likely to increase substantially in the near future [ ] . further, the rapidly expanding mobile phone penetrance, developments in cloud computing, substantial investments in health informatics, electronic medical records (emrs) and mobile health (mhealth) applications, even in resource-constrained settings, holds significant promise for increasing use and scalability of ai applications in improving public health outcomes [ ] . public health policy, practice and research will continue to benefit from the expanding framework of infodemiology and infoveillance in analyzing health information search, communication and publication behavior on the internet [ , ] . advances in cryptographic technologies-including block chain is likely to allay fears and concerns with security, privacy and confidentiality of public digital data/information [ ] . there is no doubt that ai is and will continue to revolutionize healthcare and population health. from prevention and health promotion to diagnosis and treatment, ai is increasingly being deployed to improve clinical decision-making, enhance personalized care and public health outcomes. in particular, ai offers enormous potential for cost-savings on therapeutic care given its predictive accuracy of potential outbreaks and epidemics and ability to enhance positive health seeking behaviors (at individual and population levels) during epidemics predicated upon robust infodemiology and infoveillance frameworks supported by expert systems, machine learning algorithms and mobile applications. amazing as the future of ai in healthcare seems, there are significant legal and ethical concerns that need to be addressed in order to pave way for robust implementation and scalability across a variety of socio-cultural, epidemiological, health system and political contexts. tracking infectious disease spread for global pandemic containment an update on zika virus infection neurologic complications associated with the zika virus in brazilian adults will artificial intelligence solve the human crisis in healthcare? bmc artificial intelligence for infectious disease big data analytics the human behavior-change project: harnessing the power of artificial intelligence and machine learning for evidence synthesis and interpretation recommendations for implementing the strategic initiative united nations: looking to future un to consider how artificial intelligence could help achieve economic growth and reduce inequalities detecting influenza epidemics using search engine query data google trends in 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and global health: how can ai contribute to health in resource-poor settings? image recognition of disease-carrying insects: a system for combating infectious diseases using image classification techniques and citizen science fuzzy expert systems and gis for cholera health risk prediction in southern infodemiology and infoveillance: framework for an emerging set of public health informatics methods to analyze search, communication and publication behavior on the internet infodemiology and infoveillance: tracking online health information and cyber-behavior for public health using google trends to examine the spatio-temporal incidence and behavioral patterns of dengue disease: a case study in metropolitan manila assessing ebola-related web search behavior: insights and implications from an analytical study of google trends-based query volumes public reaction to chikungunya outbreaks in italy-insights from an extensive novel data streams-based structural equation modeling analysis building a computer-based expert system for malaria environmental diagnosis: an alternative malaria control strategy developing and using expert systems and neural networks in medicine: a review on benefits and challenges semantics derived automatically from language corpora contain human-like biases machine bias accounting for healthcare-seeking behaviors and testing practices in real-time influenza forecasts algorithmic transparency via quantitative input influence: theory and experiments with learning systems. security and privacy (sp) health intelligence: how artificial intelligence transforms population and personalized health tracking health seeking behavior during an ebola outbreak via mobile phones and sms adopting m-health in clinical practice: a boon or a bane? acknowledgements we thank the ministry of health malaysia for the support to publish this chapter. key: cord- -peh efat authors: merrick, riki; hinrichs, steven h.; meigs, michelle title: public health laboratories date: - - journal: public health informatics and information systems doi: . / - - - - _ sha: doc_id: cord_uid: peh efat this chapter will review the multiple functions of public health laboratories (phls), including their differences to commercial clinical laboratories. for example, the types of samples submitted to phls differ from those submitted to commercial clinical laboratories. phls are critically important to population based healthcare; playing an essential role in the detection of disease outbreaks. this chapter will describe the hierarchical organization of the phl system in the unites states, as well as the networks that have been created to support diverse phl functions such as food safety testing and emergency response to terrorisms or natural disaster. it will briefly describe the standards used by phls and how the implementation of standards should further improve patient safety as a whole. in this chapter the reader will be introduced to phl informatics in the context of the laboratories operational workflow – from test ordering, interfacing with diagnostic instruments, quality control and result reporting and analysis. the reader will also understand the impact of phl informatics collaboration efforts and its effect on ongoing policy development. overview this chapter will review the multiple functions of public health laboratories (phls), including their differences to commercial clinical laboratories. for example, the types of samples submitted to phls differ from those submitted to commercial clinical laboratories. phls are critically important to population based healthcare; playing an essential role in the detection of disease outbreaks. this chapter will describe the hierarchical organization of the phl system in the unites states, as well as the networks that have been created to support diverse phl functions such as food safety testing and emergency response to terrorisms or natural disaster. it will briefl y describe the standards used by phls and how the implementation of standards should further improve patient safety as a whole. in this chapter the reader will be introduced to phl informatics in the context of the laboratories operational workfl ow -from test ordering, interfacing with diagnostic instruments, quality control and result reporting and analysis. the reader will also understand the impact of phl informatics collaboration efforts and its effect on ongoing policy development. public health laboratories (phls) play a vital role in protecting the public from health hazards. phls offer diagnostic testing for humans and animals as well as testing of environmental samples and products. these laboratories also provide laboratory confi rmation for special organisms, and are part of public health's (ph) disease surveillance enterprise, conferring accurate, timely identifi cation of infectious organisms or toxins during disease outbreaks. they are also critical components in disaster response and bioterrorism preparedness. phls often perform tests that are not commonly available learning objectives . illustrate how public health laboratory (phl) functions differ from clinical labs, either at hospitals or national commercial laboratories. . examine the full environment of the ph informatics domain; from the long term sustainability of an enterprise laboratory information management system (lims) to the universe of data exchange partners and networks. . demonstrate how the evolution of informatics has enhanced the phl workplace and its practice. elsewhere. the catalog of available tests at a phl varies almost as much as their organizational structures. some phls are multi-branch operations; others are university-affi liated laboratories, while others are an integrated part of a public health department [ ] . the association of state and territorial health offi cials (astho) and the association of public health laboratories (aphl), in their publication "a practical guide to public health laboratories for state health offi cials," summarize these core functions of the phl [ ]: . enable disease prevention, control and surveillance by providing diagnostic and analytical services to assess and monitor infectious, communicable, genetic, and chronic diseases as well as exposure to environmental toxicants. . provide integrated data management to capture, maintain, and communicate data essential to public health analysis and decision-making. . deliver reference and specialized testing to identify unusual pathogens, confi rm atypical or uncommon laboratory results, verify results of other laboratory tests, and perform tests not typically performed by private sector laboratories. . support environmental health and protection , including analysis of environmental samples and biological specimens, to identify and monitor potential threats. part of the monitoring also ensures regulatory compliance. . deliver testing for food safety assurance by analyzing specimens from people, food or beverages implicated in foodborne illnesses. monitor for radioactive contamination of foods and water. . promote and enforce laboratory improvement and regulation , including training and quality assurance. . assist in policy development , including developing standards and providing leadership. . ensure emergency preparedness and response by making rapid, high-volume laboratory support available as part of state and national disaster preparedness programs. . encourage public health related research to improve the practice of laboratory science and foster development of new testing methods. . champion training and education for laboratory staff in the private and public sectors in the us and abroad. . foster partnerships and communication with public health colleagues at all levels, and with managed care organizations, academia, private industry, legislators, public safety offi cials, and others, to participate in state policy planning and to support the aforementioned core functions. phls exist at all levels of government -from local to state to federal, and even internationally. there are approximately public health laboratories in the us [ ] . local phls are an intrinsic part of the safety network in underserved populationsthey are highly integrated with public health departments (phds) clinics to provide routine diagnostic testing as well as screening tests for disease prevention. lead there are state phls [ ] ; they are found in every us state and territory as well as the district of columbia. state phls often offer and perform tests that no other labs perform -be it for clinical practice (e.g., a regional reference lab for salmonella serotyping) or environmental surveillance (e.g., well water testing). their work informs public health offi cials in state government, allowing for targeted disease surveillance, quicker response to disease outbreak and provides population based data that may lead to new guidelines or policies to protect their residents. where local phls are not available, the state phl supports locally-needed public health activities. state phls also have the power to regulate private medical laboratories [ ] and operate quality assurance programs (e.g., air quality or clean water act). during surveillance activities, the state phl takes a leadership role through active collaboration with federal agencies, state epidemiologists, fi rst responders, and environmental professionals. within the us, the federal government operates several phls that act as reference labs for their state and local counterparts; they manage centers for public health program areas, and are liaisons to international organizations like the world health organization (who). these federal reference laboratories are located at the centers for disease control and prevention (cdc), the united states department of agriculture (usda), the food and drug administration (fda), and the environmental protection agency (epa). just like their state counterparts, they provide the federal government with information to help protect americans everywhere, and through global outreach they ensure laboratory capacity around the world [ ] . at the typical clinical lab, human biological samples are sent in for routine testing, such as blood sugar level, presence of bacteria, or screening for cancers. at a phl, in addition to human samples, phls also perform testing on non-human samples and even inanimate objects. animal samples are received at the phl for a number of reasons including: rabies testing, west nile virus surveillance, as well as ensuring the safety of our food animals through feed testing. water samples are also tested at the phl for a variety of reasons, but most importantly the phl monitors both well water and public water systems. food, be it peanut butter or spinach, is tested on a daily basis to detect pathogenic bacteria. our soil, building materials and even cups and plates are tested to protect citizens from high levels of toxic chemicals such as lead. and fi nally; our phls work closely with fi rst responders and the federal government to test for agents of bioterrorism; these samples can range from "white powder" to human based samples. phls also perform regularly scheduled tests on samples collected from designated sentinel (guard) sites. samples come from animals that are more susceptible to a disease, are living in close proximity to people and are being tested regularly to gauge when a new disease can be expected. the monthly testing of samples from a chicken population for west nile virus is one example. chickens are more susceptible to west nile virus infections than people. when west nile virus is detected in the chicken population, it is a good indicator that human cases can be expected soon in the same area. while commercial laboratories do report the detection of certain infectious diseases to their respective public health departments, it is the phls that are at the frontline when an infectious disease outbreak occurs. phls provide support to the public health department in identifying the cause of the latest foodborne outbreak that may have been fi rst detected at a clinical laboratory. phls also spend a significant amount of time developing new test procedures for emerging new diseases; such as the detection of the newest infl uenza virus strain that may cause the next epidemic or even a pandemic, as we experienced in . because of their effi cacy, some of these newly developed tests are adopted by commercial laboratories and offered to their customers at a later point in time. not all human samples arriving at a phl come from sick people. for example, every newborn is screened for a panel of genetic disorders to ensure early detection of issues that can sometimes save a child's life. these tests are almost exclusively performed at the phls [ ] . clinical labs perform mostly diagnostic testing, but they also offer some screening tests for example the pap smear testing to screen for cervical cancer. phls have surge capacity agreements with partner laboratories to cover the increase in testing volumes during outbreaks: if one phl is overwhelmed by the volume of samples received during an outbreak, they can send some of the samples to a neighboring phl with whom they have such an agreement. these surge capacity partners will have to have identical, or at least similar, testing capabilities, hence they are mainly other phls. because phls are critical to the health of a population, they also have continuity of care agreements to ensure that, in the event one phl is affected by a natural disaster, the other partner will perform their duties. hurricane katrina put these agreements to the test, especially in the areas of newborn screening, where test requests were successfully transferred to partner phls, because babies don't wait to be born because of a disaster ( fig. since the advent of computers, the laboratory, with its capacity to produce and manage important data, has been at the forefront of health informatics. what initially began as a database for local results, over time developed into a laboratory information management system (lims) that provides capacity for improved workfl ow management, inventory tracking, and most importantly, patient management. testing is often performed on stand-alone instruments. these results need to be incorporated into the lims, in order to be included in the fi nal result sent to the submitter. in the beginning the lims was capturing only those results that needed to be printed to be sent back to the submitter. with the improvement of informatics knowledge in the phls more and more of the instruments are being interfaced, using industry developed standards, improving the quality of data and making the workfl ow more effi cient. informatics practice certainly has transformed several laboratory workfl ows as organizations migrate from paper-based to electronic system-based tracking. being able to draw data from a database in an electronic format facilitates secondary use of this information for forecasting or event detection. this information can then be shared with partners in the public health laboratory system (e.g., the public health department, a regional taskforce, preparedness coordinators, policy makers and federal agencies). the capability of the laboratory and its public health partners to share data in the same format, through an electronic data interchange (edi), can greatly reduce communication delays between partners; resulting in faster, better outcomes for both patient and population based responses. all these functions are covered by informatics principlesfrom database design to queries as well as application of format and content standards. . inventory and forms management . general laboratory reporting -is part of the general systems requirementsall electronic data management systems need to be able to create reports . statistical analysis and surveillance -provides value added to the test results to both the submitters of the sample as well as public health partners . billing for services . contract and grant management -unlike clinical laboratories, phls often are funded through grants to provide services free of charge to the submitter of the sample, so tracking funding amounts and requirements is important . training, education and resource management -to comply with regulations and to document capacity of laboratory personnel and equipment . lab certifi cations and licensing -phls, mostly at the state level, are responsible to ensure compliance in laboratories operating in their jurisdiction, which includes inspections of those laboratories . customer feedback tracking . quality control (qc) and quality assurance (qa) management -both involve audit functionality about the tests performed -qc tracks the parameters for each method and instrument at the test level and allows for over time analysis of the control parameters, while qa defi nes specifi c measures across all the tests performed to ensure accurate testing . laboratory safety and accident investigation . laboratory mutual assistance and disaster recovery to support surge capacity and continuity of care operations not all business processes apply to every lab, but across the spectrum of laboratories all of these business processes are relevant. this document describes interdependencies between the lab and outside partners and following informatics protocol decomposes each of the core business processes into their individual steps with related functional requirements for the system, based on detailed laboratory workfl ow analysis [ ] . the publication of this requirements document has created a functional standard vendors can utilize to build more useful systems that are conformant with these requirements. although much variability between information systems still exists, this requirement document has provided a solid basis to better identify and pin-point these variations. the phls use several kinds of codes in their daily operations: codes for the tests they offer and perform, codes for pre-defi ned results, and codes for patient demographics. in order to make data comparable across locations, the phls map their local codes to national data standards. these data standards include the logical identifi ers names and codes (loinc ® ) [ ] for the tests they perform, systematized nomenclature of medicine (snomed ® ) [ ] to identify organisms and ordinal results, and codes from health level seven (hl ® ) [ ] for patient demographics like gender, race, and ethnicity. to exchange standardized data between phls and their partners, the order and format of the data to be exchanged needs to be defi ned. for individual point to point exchanges, simpler formats can be agreed upon; for example, comma-separated fi les (csv) or excel spreadsheets can be exchanged, but in order to accommodate larger scale data exchange with multiple partners across multiple information systems standards such as hl ® messages (in version .x) or the xml-based clinical document architecture (cda) formats should always be considered as part of the normal business process. in addition to utilizing these standards, transport mechanisms need to be defi ned and agreed upon by electronic data interchange (edi) partners [ ] . in order to support these critical public health functions, phls create support networks among themselves. these networks help group laboratories together that perform the same kinds of tests and exchange results within the same networks, usually under the guidance of a federal program. utilization of the requirements document among phls has advanced the application of informatics in the phl realm, and has made several of these networks quite successful. examples of functional phl networks in the us are summarized in table . . unfortunately, at this stage each of these networks is using different data exchange methods. lrn and nahln use hl ® v .x messages as data exchange standard, fern and erln use xml-based electronic data deliverables (edds). this forces the phl to support a variety of formats and vocabularies in order to properly report to the respective partners during an investigation. a signifi cant obstacle to the development of consistent data exchange deliverables is the sheer number of networks and reporting requirements. table . shows what a laboratory must do, after discovery of a food-borne illness outbreak due to consumption of tainted hamburgers. the following barriers to effective electronic laboratory information exchange were identifi ed in the aphl-phdsc white paper, "assure health it standards for public health, part : health it standards in public health laboratory domain," [ ] : barrier i -the incomplete and inconsistent adoption of existing standards by the wide array of laboratories responsible for reporting laboratory results as well as by the electronic health record systems (ehr-s) and public health information systems they report to. barrier ii -the lack of adoption of ehr-s [ ] in clinical settings (i.e., test order senders and result receivers) preventing electronic communication between providers and lims. barrier iii -the use of proprietary, non-standardized information systems in public health preventing electronic communication between lims and public health programs (i.e., receivers of test results on public health threat conditions). barrier iv -the absence of a sustainable approach and funding to support the development of laboratory standards and their testing; and of certifi cation and adoption of standards-based it products in clinical, laboratory and public health settings. barrier v -the need for informatics-savvy personnel in phls to operate in a new hit and information communication environment. the association of public health laboratories (aphl) is a national non-profi t, member-based organization representing governmental laboratories of all levels in all aspects of operation. aphl is especially active as the primary advocate for phls network description lrn [ ] the cdc manages the laboratory response network (lrn). this includes the cdc lrn-biological (lrn-b) and cdc lrn-chemical (lrn-c). the mission of the lrn is "to maintain an integrated national and international network of laboratories that are fully equipped to respond quickly to acts of chemical and biological terrorism, emerging infectious diseases, and other public health threats and emergencies." due to the sensitive nature of cdc's bioterrorism preparedness activities, details of lrn-b operations are protected against general public access and distribution. these details, designated as "sensitive but unclassifi ed," are maintained at cdc, and require coordination with the lrn lims integration team to obtain. the lrn provides specifi cations about the message format (hl ® v .x) and data content, including standardized vocabulary (for example loinc ® and snomed ct ® ) erln [ ] the environmental response laboratory network (erln) is managed by epa. the erln consists of federal, state, and commercial laboratories that focus on responding quickly to an environmental chemical, biological, or radiological terrorist attack, as well as natural disasters affecting human health and the environment. the erln provides an electronic data deliverable (edd), which can be either a spreadsheet or the recommended xml format and a data exchange template (det) with data element defi nitions and groupings. the erln also provides a web-based electronic data review tool that automates the assessment of edds by providing web access for upload by the laboratory and review by project personnel department of agriculture (usda)'s food safety and inspection service and the food and drug administration (fda). the primary objectives of fern are to help prevent attacks on the food supply through utilization of targeted food surveillance; prepare for emergencies by strengthening laboratory capabilities to respond to threats, attacks, and emergencies in the food supply; and to assist in recovery from such an incident. fern uses the electronic laboratory exchange network (elexnet) that allows multiple government agencies engaged in food safety activities to compare, communicate, and coordinate fi ndings of laboratory analyses nahln [ ] the national animal health laboratory network's (nahln) purpose is to enhance the nation's early detection of, response to, and recovery from animal health emergencies. such emergencies might include bioterrorist incidents, newly emerging diseases, and foreign animal disease agents that threaten the nation's food supply and public health gisn [ ] the who global infl uenza surveillance network (gisn) receives result reports and samples of isolates from participating state and municipal phls to monitor infl uenza disease burden, detect potential novel pandemic strains, and obtain suitable virus isolates for vaccine development by promoting workfl ow improvements and refi ning laboratory science operations within the laboratory. it provides a forum for member collaboration, education, and workforce development [ ] . the fruits of this collaboration are evident in the success of aphl's informatics committee in identifying and subsequently improving many of the functions required of lims and in the domain of laboratory informatics in general. one such example is the effort to standardize lims functionality across vendors. aphl lims user groups provide ways to prioritize and consolidate development efforts among customers of a specifi c vendor, which in turn can be easily compared to overall standardization approach. in partnership with other ph organizations, under the umbrella of the joint public health informatics taskforce (jphit), aphl also infl uences national e-health policy. internationally, aphl helps to build laboratory capacity in developing countries, including the selection and implementation of information systems. as part of every implementation, validation testing according to test cases also employs informatics principles. having identifi ed the need to harmonize the adoption of standards across federal programs and phl functional areas, aphl is actively involved in national standards harmonization activities for laboratoryrelated use cases (information exchange standards for laboratory orders and results, reporting in clinical and public health settings, as well as functional standards for electronic health record system (ehr-s) interactions with phls). due to limited informatics funding at phls and the ongoing struggle for these laboratories to support informatics trained specialists, aphl provides hands on informatics technical assistance to phls and their partners. these services include project management, national standards implementation and technical architecture support. phls are continually providing expertise to support the standards development process. they were instrumental in creating an implementation guide for newborn screening; working alongside standards development organizations (sdos) like the regenstrief institute to develop the required vocabulary and to make sure the hl ® message contained all the data elements needed for proper newborn screening result reporting. aphl provides leadership for the laboratory and messaging community of practice (labmcop), assisting phls and partners in harmonizing terminology and related standardized vocabulary to properly describe the specimen submitted for testing. on a national scale, when the offi ce of the national coordinator for health information technology (onc)'s certifi cation process for commercial electronic health record products was announced, phl expertise was utilized by providing real-world testing scenarios to ensure that specifi c result formats are properly represented in this information exchange paradigm. by ensuring a basis in reality, this effort will ensure greater patient safety, and improve public health's response to emerging diseases, terrorism, and natural disasters. in summary, phls are a critical public health resource and service. they detect, identify and monitor infectious disease outbreaks, chemical or biological contamination in people, animals, food and the environment. they provide testing that other labs cannot provide and screen for diseases that haven't even shown symptoms yet (i.e. newborn screening). phl testing supports food and environmental safety law enforcement and their data contributes vital information to support local, state and federal health policies. phls are at the forefront of population based health threats due to bioterrorism, newly emerging disease and natural disasters and they continue to ensure quality service by inspecting and certifying other laboratories in their jurisdiction. information systems enable phls, or any laboratory for that matter, to more predictably forecast testing demand and assist with human resource utilization during an outbreak or response. auditing functionality help to monitor the quality of testing and this analysis can be used to improve laboratory workfl ow over time. data derived from these systems can assist with both state and federal efforts to forecast disease, help with outbreak management as well as health policy development. but to ensure the long term operational capacity of our phls to provide these services and remain relevant in patient and population care, informatics must be considered a pivotal core business function. the use of electronic test orders, communicating between disparate systems about order statuses and specimen results as well as contributions to both electronic health records and personal health records submitters all require use and continual development of national data exchange standards. the work in this fi eld has barely begun, yet the continual evolution of standards will drive greater collaboration and cooperation between all levels of phls -local, state and federal as well as their commercial partners. community-driven standards-based electronic laboratory data-sharing networks association of public health laboratories and the association of state and territorial health offi cials. a practical guide to public health laboratories for state health offi cials. silver spring: association of public health laboratories public health laboratories: analysis, answers, action. aphl, silver spring association of public health laboratories: member lab listings association of public health laboratories. defending the public's health. silver spring: aphl association of public health laboratories. defi nition of a state public health laboratory system. silver spring: aphl aphl -internal documentation public health informatics institute. requirements for public health laboratory information management systems: a collaboration of state public health laboratories. aphl logical identifi ers names and codes (loinc ® ). web health level seven about hl ® . web public health data standards consortium and aphl white paper. assure health it standards for public health part : hit standards in public health laboratory domain centers for disease and prevention. the laboratory response network, partners in preparedness animal and plant health inspection service, animal health, national animal health laboratory network who global infl uenza surveillance network (gisn), surveillance and vaccine development offi ce of national coordinator for health it. health it adoption. dhhs association of public health laboratories about aphl. aphl, silver spring association of public health laboratories . list at least of the core phl functions and discuss how each of them can be supported by informatics. . how does the workfl ow in a phl change when an emergency arises -for example a disease outbreak, a bioterrorism event or a natural disaster? . list the different partners of a phl and their importance for public health. . contrast the differences and similarities between a phl and a commercial clinical lab. key: cord- - fh mk authors: yasnoff, william a.; o'carroll, patrick w.; friede, andrew title: public health informatics and the health information infrastructure date: journal: biomedical informatics doi: . / - - - _ sha: doc_id: cord_uid: fh mk what are the three core functions of public health, and how do they help shape the different foci of public health and medicine? what are the current and potential effects of a) the genomics revolution; and b) / on public health informatics? what were the political, organizational, epidemiological, and technical issues that influenced the development of immunization registries? how do registries promote public health, and how can this model be expanded to other domains (be specific about those domains) ? how might it fail in others?why? what is the vision and purpose of the national health information infrastructure? what kinds of impacts will it have, and in what time periods? why don’t we have one already? what are the political and technical barriers to its implementation? what are the characteristics of any evaluation process that would be used to judge demonstration projects? biomedical informatics includes a wide range of disciplines that span information from the molecular to the population level. this chapter is primarily focused on the population level, which includes informatics applied to public health and to the entire health care system (health information infrastructure). population-level informatics has its own special problems, issues, and considerations. creating information systems at the population level has always been very difficult because of the large number of data elements and individuals that must be included, as well as the need to address data and information issues that affect health in the aggregate (e.g., environmental determinants of health). with faster and cheaper hardware and radically improved software tools, it has become financially and technically feasible to create information systems that will provide the information about individuals and populations necessary for optimized decision-making in medical care and public health. however, much work remains to fully achieve this goal. this chapter deals with public health informatics primarily as it relates to the medical care of populations. however, it should be emphasized that the domain of public health informatics is not limited to the medical care environment. for example, information technology is being applied to automatically detect threats to health from the food supply, water systems, and even driving conditions (such as obstacles on the roadway beyond the reach of visible headlight beams), and to assist in man-made or natural disaster management. monitoring the environment for health risks due to biological, chemical, and radiation exposures (natural and made-made) is of increasing concern to protecting the public's health. for example, systems are now being developed and deployed to rapidly detect airborne bioterror agents. although they do not directly relate to medical care, these applications designed to protect human health should properly be considered within the domain of public health informatics. public health informatics has been defined as the systematic application of information and computer science and technology to public health practice, research, and learning (friede et al., ; yasnoff et al., ) . public health informatics is distinguished by its focus on populations (versus the individual), its orientation to prevention (rather than diagnosis and treatment), and its governmental context, because public health nearly always involves government agencies. it is a large and complex area that is the focus of another entire textbook in this series (o'carroll et al., ) . the differences between public health informatics and other informatics specialty areas relate to the contrast between public health and medical care itself (friede & o'carroll, ; yasnoff et al., ) . public health focuses on the health of the community, as opposed to that of the individual patient. in the medical care system, individuals with specific diseases or conditions are the primary concern. in public health, issues related to the community as the patient may require "treatment" such as disclosure of the disease status of an individual to prevent further spread of illness or even quarantining some individuals to protect others. environmental factors, especially ones that that affect the health of populations over the long term (e.g. air quality), are also a special focus of the public health domain. public health places a large emphasis on the prevention of disease and injury versus intervention after the problem has already occurred. to the extent that traditional medical care involves prevention, its focus is primarily on delivery of preventive services to individual patients. public health actions are not limited to the clinical encounter. in public health, the nature of a given intervention is not predetermined by professional discipline, but rather by the cost, expediency, and social acceptability of intervening at any potentially effective point in the series of events leading to disease, injury, or disability. public health interventions have included (for example) wastewater treatment and solid waste disposal systems, housing and building codes, fluoridation of municipal water supplies, removal of lead from gasoline, and smoke alarms. contrast this with the modern healthcare system, which generally accomplishes its mission through medical and surgical encounters. public health also generally operates directly or indirectly through government agencies that must be responsive to legislative, regulatory, and policy directives, carefully balance competing priorities, and openly disclose their activities. in addition, certain public health actions involve authority for specific (sometimes coercive) measures to protect the community in an emergency. examples include closing a contaminated pond or a restaurant that fails inspection. community partners to provide such care. though there is great variation across jurisdictions, the fundamental assurance function is unchanged: to assure that all members of the community have adequate access to needed services. the assurance function is not limited to access to clinical care. rather, it refers to assurance of the conditions that allow people to be healthy and free from avoidable threats to health-which includes access to clean water, a safe food supply, well-lighted streets, responsive and effective public safety entities, and so forth. this "core functions" framework has proven to be highly useful in clarifying the fundamental, over-arching responsibilities of public health. but if the core functions describe what public health is for, a more detailed and grounded delineation was needed to describe what public health agencies do. to meet this need, a set of ten essential public health services (table . ) was developed through national and state level deliberations of public health providers and consumers (department of health and human services (dhhs), ). it is through these ten services that public health carries out its mission to assure the conditions in which people can be healthy. the core function of assessment, and several of the essential public health services rely heavily on public health surveillance, one of the oldest systematic activities of the public health sector. surveillance in the public health context refers to the ongoing collection, analysis, interpretation, and dissemination of data on health conditions (e.g., breast cancer) and threats to health (e.g., smoking prevalence). surveillance data represent one of the fundamental means by which priorities for public health action are set. surveillance data are useful not only in the short term (e.g., in surveillance for acute infectious diseases such as influenza, measles, and hiv/aids), but also in the longer term, e.g., in determining leading causes of premature death, injury, or disability. in either case, what distinguishes surveillance is that the data are collected for the purposes of action-either to guide a public health response (e.g., an outbreak investigation, or mitigation of a threat to a food or water source) or to help direct public health policy. a recent example of the latter is the surveillance data showing the dramatic rise in obesity in the united states. a tremendous amount of energy and public focus has been brought to bear on this problem-including a major dhhs program, the healthierus initiative-driven largely by compelling surveillance data. . monitor the health status of individuals in the community to identify community health problems . diagnose and investigate community health problems and community health hazards . inform, educate, and empower the community with respect to health issues . mobilize community partnerships in identifying and solving community health problems . develop policies and plans that support individual and community efforts to improve health . enforce laws and rules that protect the public health and ensure safety in accordance with those laws and rules . link individuals who have a need for community and personal health services to appropriate community and private providers . ensure a competent workforce for the provision of essential public health services . research new insights and innovate solutions to community health problems . evaluate the effectiveness, accessibility, and quality of personal and population-based health services in a community the fundamental science of public health is epidemiology, which is the study of the prevalence and determinants of disability and disease in populations. hence, most public health information systems have focused on information about aggregate populations. almost all medical information systems focus almost exclusively on identifying information about individuals. for example, almost any clinical laboratory system can quickly find jane smith's culture results. what public health practitioners want to know is the time trend of antibiotic resistance for the population that the clinic serves, or the trend for the population that the clinic actually covers. most health care professionals are surprised to learn that there is no uniform national routine reporting -never mind information system -for most diseases, disabilities, risk factors, or prevention activities in the united states. in contrast, france, great britain, denmark, norway and sweden have comprehensive systems in selected areas, such as occupational injuries, infectious diseases, and cancer; no country, however, has complete reporting for every problem. in fact, it is only births, deaths, and -to a lesser extentfetal deaths that are uniformly and relatively completely reported in the united states by the national vital statistics system, operated by the states and the centers for disease control and prevention (cdc). if you have an angioplasty and survive, nobody at the state or federal level necessarily knows. public health information systems have been designed with special features. for example, they are optimized for retrieval from very large (multi-million) record databases, and to be able to quickly cross-tabulate, study secular trends, and look for patterns. the use of personal identifiers in these systems is very limited, and their use is generally restricted to linking data from different sources (e.g., data from a state laboratory and a disease surveillance form). a few examples of these kinds of populationfocused systems include cdc systems such as the hiv/aids reporting system, which collects millions of observations concerning people infected with the human immunodeficiency virus (hiv) and those diagnosed with acquired immunodeficiency syndrome (aids) and is used to conduct dozens of studies (and which does not collect personal identifiers; individuals are tracked by pseudo-identifiers); the national notifiable disease surveillance system, which state epidemiologists use to report some diseases (the exact number varies as conditions wax and wane) every week to the cdc (and which makes up the center tables in the morbidity and mortality weekly report [mmwr] ). the cdc wonder system (friede et al., ) , which contains tens of millions of observations drawn from some databases, explicitly blanks cells with fewer than three to five observations (depending on the dataset), specifically to prevent individuals with unusual characteristics from being identified. if there is no national individual reporting, how are estimates obtained for, say, the trends in teenage smoking or in the incidence of breast cancer? how are epidemics found? data from periodic surveys and special studies, surveillance systems, and disease registries are handled by numerous stand-alone information systems. these systemsusually managed by state health departments and federal health agencies (largely the cdc) or their agents -provide periodic estimates of the incidence and prevalence of diseases and of certain risk factors (for example, smoking and obesity); however, because the data are from population samples, it is usually impossible to obtain estimates at a level of geographic detail finer than a region or state. moreover, many of the behavioral indices are patient self-reported (although extensive validation studies have shown that they are good for trends and sometimes are more reliable than are data obtained from clinical systems). in the case of special surveys, such as cdc's national health and nutrition examination survey (nhanes), there is primary data entry into a cdc system. the data are complete, but the survey costs many millions of dollars, is done only every few years, and it takes years for the data to be made available. there are also disease registries that track -often completely -the incidence of certain conditions, especially cancers, birth defects, and conditions associated with environmental contamination. they tend to focus on one topic or to cover certain diseases for specific time periods. the cdc maintains dozens of surveillance systems that attempt to track completely the incidence of many conditions, including lead poisoning, injuries and deaths in the workplace, and birth defects. (some of these systems use samples or cover only certain states or cities). as discussed above, there is also a list of about notifiable diseases (revised every year) that the state epidemiologists and the cdc have determined are of national significance and warrant routine, complete reporting; however, it is up to providers to report the data, and reporting is still often done by telephone or mail, so the data are incomplete. finally, some states do collect hospital discharge summaries, but now that more care is being delivered in the ambulatory setting, these data capture only a small fraction of medical care. they are also notoriously difficult to access. what all these systems have in common is that they rely on special data collection. it is rare that they are seamlessly linked to ongoing clinical information systems. even clinical data such as hospital infections is reentered. why? all these systems grew up at the same time that information systems were being put in hospitals and clinics. hence, there is duplicate data entry, which can result in the data being shallow, delayed, and subject to input error and recall bias. furthermore, the systems themselves are often unpopular with state agencies and health care providers precisely because they require duplicate data entry (a child with lead poisoning and salmonella needs to be entered in two different cdc systems). the national electronic disease surveillance system (nedss) is a major cdc initiative that addresses this issue by promoting the use of data and information system standards to advance the development of efficient, integrated, and interoperable surveillance systems at federal, state and local levels (see www.cdc.gov/nedss). this activity is designed to facilitate the electronic transfer of appropriate information from clinical information systems in the health care industry to public health departments, reduce provider burden in the provision of information, and enhance both the timeliness and quality of information provided. now that historical and epidemiological forces are making the world smaller and causing lines between medicine and public health to blur, systems will need to be multifunctional, and clinical and public health systems will, of necessity, coalesce. what is needed are systems that can tell us about individuals and the world in which those individuals live. to fill that need, public health and clinical informaticians will need to work closely together to build the tools to study and control new and emerging threats such as bioterror, hiv/aids, sars and its congeners, and the environmental effects of the shrinking ozone layer and greenhouse gases. it can be done. for example, in the late 's, columbia presbyterian medical center and the new york city department of health collaborated on the development of a tuberculosis registry for northern manhattan, and the emory university system of health care and the georgia department of public health built a similar system for tuberculosis monitoring and treatment in atlanta. it is not by chance that these two cities each developed tuberculosis systems; rather, tuberculosis is a perfect example of what was once a public health problem (that affected primarily the poor and underserved) coming into the mainstream population as a result of an emerging infectious disease (aids), immigration, increased international travel, multidrug resistance, and our growing prison population. hence, the changing ecology of disease, coupled with revolutionary changes in how health care is managed and paid for, will necessitate information systems that serve both individual medical and public health needs. immunization registries are confidential, population based, computerized information systems that contain data about children and vaccinations (national vaccine advisory committee, ). they represent a good example for illustrating the principles of public health informatics. in addition to their orientation to prevention, they can only function properly through continuing interaction with the health care system. they also must exist in a governmental context because there is little incentive (and significant organizational barriers) for the private sector to maintain such registries. although immunization registries are among the largest and most complex public health information systems, the successful implementations show conclusively that it is possible to overcome the challenging informatics problems they present. childhood immunizations have been among the most successful public health interventions, resulting in the near elimination of nine vaccine preventable diseases that historically extracted a major toll in terms of both morbidity and mortality (iom, a) . the need for immunization registries stems from the challenge of assuring complete immunization protection for the approximately , children born each day in the united states in the context of three complicating factors: the scattering of immunization records among multiple providers; an immunization schedule that has become increasingly complex as the number of vaccines has grown; and the conundrum that the very success of mass immunization has reduced the incidence of disease, lulling parents and providers into a sense of complacency. the - u.s. measles outbreak, which resulted in , cases and preventable deaths (atkinson et al., ) , helped stimulate the public health community to expand the limited earlier efforts to develop immunization registries. because cdc was proscribed by congress from creating a single national immunization registry (due to privacy concerns), the robert wood johnson foundation, in cooperation with several other private foundations, established the all kids count (akc) program that awarded funds to states and communities in to assist in the development of immunization registries. akc funded the best projects through a competitive process, recruited a talented staff to provide technical assistance, and made deliberate efforts to ensure sharing of the lessons learned, such as regular, highly interactive meetings of the grantees. subsequent funding of states by cdc and the woodruff foundation via the information network for public health officials (inpho) project (baker et al., ) was greatly augmented by a presidential commitment to immunization registries announced in (white house, ) . this resulted in every state's involvement in registry development. immunization registries must be able to exchange information to ensure that children who relocate receive needed immunizations. to accomplish this, standards were needed to prevent the development of multiple, incompatible immunization transmission formats. beginning in , cdc worked closely with the health level standards development organization (see chapter ) to define hl messages and an implementation guide for immunization record transactions. the initial data standard was approved by hl in and an updated implementation guide was developed in . cdc continues its efforts to encourage the standards-based exchange of immunization records among registries. as more experience accumulated, akc and cdc collaborated to develop an immunization registry development guide (cdc, ) that captured the hard-won lessons developed by dozens of projects over many years. by , a consensus on the needed functions of immunization registries had emerged (table . ), codifying years of experience in refining system requirements. cdc also established a measurement system for tracking progress that periodically assesses the percentage of immunization registries that have operationalized each of the functions ( figure . electronically store data regarding all national vaccine advisory committee-approved core data elements . establish a registry record within weeks of birth for each child born in the catchment area . enable access to vaccine information from the registry at the time of the encounter . receive and process vaccine information within month of vaccine administration . protect the confidentiality of medical information . protect the security of medical information . exchange vaccination records by using health level standards . automatically determine the immunization(s) needed when a person is seen by the health care provider for a scheduled vaccination . automatically identify persons due or late for vaccinations to enable the production of reminder and recall notices . automatically produce vaccine coverage reports by providers, age groups, and geographic areas . produce authorized immunization records . promote accuracy and completeness of registry data registries, the national healthy people objectives include the goal of having % of all u.s. children covered by fully functioning immunization registries (dhhs, ) . the development and implementation of immunization registries presents challenging informatics issues in at least four areas: ) interdisciplinary communication; ) organizational and collaborative issues; ) funding and sustainability; and ) system design. while the specific manifestations of these issues are unique to immunization registries, these four areas represent the typical domains that must be addressed and overcome in public health informatics projects. interdisciplinary communications is a key challenge in any biomedical informatics project-it is certainly not specific to public health informatics. to be useful, a public health information system must accurately represent and enable the complex concepts and processes that underlie the specific business functions required. information systems represent a highly abstract and complex set of data, processes, and interactions. this complexity needs to be discussed, specified, and understood in detail by a variety of personnel with little or no expertise in the terminology and concepts of information technology. therefore, successful immunization registry implementation requires clear communication among public health specialists, immunization specialists, providers, it specialists, and related disciplines, an effort complicated by the lack of a shared vocabulary and differences in the usage of common terms from the various domains. added to these potential communication problems are the anxieties and concerns inherent in the development of any new information system. change is an inevitable part of such a project-and change is uncomfortable for everyone involved. implementation of information systems. in this context, tensions and anxieties can further degrade communications. to deal with the communications challenges, particularly between it and public health specialists, it is essential to identify an interlocutor who has familiarity with both information technology and public health. the interlocutor should spend sufficient time in the user environment to develop a deep understanding of the information processing context of both the current and proposed systems. it is also important for individuals from all the disciplines related to the project to have representation in the decisionmaking processes. the organizational and collaborative issues involved in developing immunization registries are daunting because of the large number and wide variety of partners. both public and private sector providers and other organizations are likely participants. for the providers, particularly in the private sector, immunization is just one of many concerns. however, it is essential to mobilize private providers to submit immunization information to the registry. in addition to communicating regularly to this group about the goals, plans, and progress of the registry, an invaluable tool to enlist their participation is a technical solution that minimizes their time and expense for registry data entry, while maximizing the benefit in terms of improved information about their patients. it is critical to recognize the constraints of the private provider environment, where income is generated mostly from "piecework" and time is the most precious resource. governance issues are also critical to success. all the key stakeholders need to be represented in the decision-making processes, guided by a mutually acceptable governance mechanism. large information system projects involving multiple partners -such as immunization registries -often require multiple committees to ensure that all parties have a voice in the development process. in particular, all decisions that materially affect a stakeholder should be made in a setting that includes their representation. legislative and regulatory issues must be considered in an informatics context because they impact the likelihood of success of projects. with respect to immunization registries, the specific issues of confidentiality, data submission, and liability are critical. the specific policies with respect to confidentiality must be defined to allow access to those who need it while denying access to others. regulatory or legislative efforts in this domain must also operate within the context of the federal health insurance portability and accountability act (hipaa) that sets national minimum privacy requirements for personal health information. some jurisdictions have enacted regulations requiring providers to submit immunization data to the registry. the effectiveness of such actions on the cooperation of providers must be carefully evaluated. liability of the participating providers and of the registry operation itself may also require legislative and/or regulatory clarification. funding and sustainability are continuing challenges for all immunization registries. in particular, without assurances of ongoing operational funding, it will be difficult to secure the commitments needed for the development work. naturally, an important tool for securing funding is development of a business case that shows the anticipated costs and benefits of the registry. while a substantial amount of information now exists about costs and benefits of immunization registries (horne et al., ) , many of the registries that are currently operational had to develop their business cases prior to the availability of good quantitative data. specific benefits associated with registries include preventing duplicative immunizations, eliminating the necessity to review the vaccination records for school and day care entry, and efficiencies in provider offices from the immediate availability of complete immunization history information and patient-specific vaccine schedule recommendations. the careful assessment of costs and benefits of specific immunization registry functions may also be helpful in prioritizing system requirements. as with all information systems, it is important to distinguish "needs" (those things people will pay for) from "wants" (those things people would like to have but are not willing to spend money on) (rubin, ). information system "needs" are typically supported by a strong business case, whereas "wants" often are not. system design is also an important factor in the success of immunization registries. difficult design issues include data acquisition, database organization, identification and matching of children, generating immunization recommendations, and access to data, particularly for providers. acquiring immunization data is perhaps the most challenging system design issue. within the context of busy pediatric practices (where the majority of childhood immunizations are given), the data acquisition strategy must of necessity be extremely efficient. ideally, information about immunizations would be extracted from existing electronic medical records or from streams of electronic billing data; either strategy should result in no additional work for participating providers. unfortunately neither of these options is typically available. electronic medical records are currently implemented only in roughly - % of physician practices. while the use of billing records is appealing, it is often difficult to get such records on a timely basis without impinging on their primary function-namely, to generate revenue for the practice. also, data quality, particularly with respect to duplicate records, is often a problem with billing information. a variety of approaches have been used to address this issue, including various forms of direct data entry as well as the use of bar codes (yasnoff, ) . database design also must be carefully considered. once the desired functions of an immunization registry are known, the database design must allow efficient implementation of these capabilities. the operational needs for data access and data entry, as well as producing individual assessments of immunization status, often require different approaches to design compared to requirements for population-based immunization assessment, management of vaccine inventory, and generating recall and reminder notices. one particularly important database design decision for immunization registries is whether to represent immunization information by vaccine or by antigen. vaccinebased representations map each available preparation, including those with multiple antigens, into its own specific data element. antigen-based representations translate multi-component vaccines into their individual antigens prior to storage. in some cases, it may be desirable to represent the immunization information both ways. specific consideration of required response times for specific queries must also be factored into key design decisions. identification and matching of individuals within immunization registries is another critical issue. because it is relatively common for a child to receive immunizations from multiple providers, any system must be able to match information from multiple sources to complete an immunization record. in the absence of a national unique patient identifier, most immunization registries will assign an arbitrary number to each child. of course, provisions must be made for the situation where this identification number is lost or unavailable. this requires a matching algorithm, which utilizes multiple items of demographic information to assess the probability that two records are really data from the same person. development of such algorithms and optimization of their parameters has been the subject of active investigation in the context of immunization registries, particularly with respect to deduplication (miller et al., ) . another critical design issue is generating vaccine recommendations from a child's prior immunization history, based on guidance from the cdc's advisory committee on immunization practices (acip). as more childhood vaccines have become available, both individually and in various combinations, the immunization schedule has become increasingly complex, especially if any delays occur in receiving doses, a child has a contraindication, or local issues require special consideration. the language used in the written guidelines is sometimes incomplete, not covering every potential situation. in addition, there is often some ambiguity with respect to definitions, e.g., for ages and intervals, making implementation of decision support systems problematic. considering that the recommendations are updated relatively frequently, sometimes several times each year, maintaining software that produces accurate immunization recommendations is a continuing challenge. accordingly, the implementation, testing, and maintenance of decision support systems to produce vaccine recommendations has been the subject of extensive study (yasnoff & miller, ) . finally, easy access to the information in an immunization registry is essential. while this may initially seem to be a relatively simple problem, it is complicated by private providers' lack of high-speed connectivity. even if a provider office has the capability for internet access, for example, it may not be immediately available at all times, particularly in the examination room. immunization registries have developed alternative data access methods such as fax-back and telephone query to address this problem. since the primary benefit of the registry to providers is manifest in rapid access to the data, this issue must be addressed. ready access to immunization registry information is a powerful incentive to providers for entering the data from their practice. in the united states, the first major report calling for a health information infrastructure was issued by the institute of medicine of the national academy of sciences in (iom, ) . this report, "the computer-based patient record," was the first in a series of national expert panel reports recommending transformation of the health care system from reliance on paper to electronic information management. in response to the iom report, the computer-based patient record institute (cpri), a private not-for-profit corporation, was formed for the purpose of facilitating the transition to computer-based records. a number of community health information networks (chins) were established around the country in an effort to coalesce the multiple community stakeholders in common efforts towards electronic information exchange. the institute of medicine updated its original report in (iom, ), again emphasizing the urgency to apply information technology to the information intensive field of health care. however, most of the community health information networks were not successful. perhaps the primary reason for this was that the standards and technology were not yet ready for cost-effective community-based electronic health information exchange. another problem was the focus on availability of aggregated health information for secondary users (e.g., policy development), rather than individual information for the direct provision of patient care. also, there was neither a sense of extreme urgency nor were there substantial funds available to pursue these endeavors. however, at least one community, indianapolis, continued to move forward throughout this period and has now emerged as an a national example of the application of information technology to health care both in individual health care settings and throughout the community. the year brought widespread attention to this issue with the iom report "to err is human" (iom, b) . in this landmark study, the iom documented the accumulating evidence of the high error rate in the medical care system, including an estimated , to , preventable deaths each year in hospitals alone. this report has proven to be a milestone in terms of public awareness of the consequences of paperbased information management in health care. along with the follow-up report, "crossing the quality chasm" (iom, ) , the systematic inability of the health care system to operate at high degree of reliability has been thoroughly elucidated. the report clearly placed the blame on the system, not the dedicated health care professionals who work in an environment without effective tools to promote quality and minimize errors. several additional national expert panel reports have emphasized the iom findings. in , the president's information technology advisory committee (pitac) issued a report entitled "transforming health care through information technology" (pitac, ) . that same year, the computer science and telecommunications board of the national research council (nrc) released "networking health: prescriptions for the internet" (nrc, ) which emphasized the potential for using the internet to improve electronic exchange of health care information. finally, the national committee on vital and health statistics (ncvhs) outlined the vision and strategy for building a national health information infrastructure (nhii) in its report, "information for health" (ncvhs, ) . ncvhs, a statutory advisory body to dhhs, indicated that federal government leadership was needed to facilitate further development of an nhii. on top of this of bevy of national expert panel reports, there has been continuing attention in both scientific and lay publications to cost, quality, and error issues in the health care system. the anthrax attacks of late further sensitized the nation to the need for greatly improved disease detection and emergency medical response capabilities. what has followed has been the largest-ever investment in public health information infrastructure in the history of the united states. some local areas, such as indianapolis and pittsburgh, have begun to actively utilize electronic information from the health care system for early detection of bioterrorism and other disease outbreaks. in , separate large national conferences were devoted to both the cdc's public health information network (phin) (cdc, ) and the dhhs nhii initiative (dhhs, yasnoff et al., . while the discussion here has focused on the development of nhii in the united states, many other countries are involved in similar activities and in fact have progressed further along this road. canada, australia, and a number of european nations have devoted considerable time and resources to their own national health information infrastructures. the united kingdom, for example, has announced its intention to allocate several billion pounds over the next few years to substantially upgrade its health information system capabilities. it should be noted, however, that all of these nations have centralized, government-controlled health care systems. this organizational difference from the multifaceted, mainly private health care system in the u.s. results in a somewhat different set of issues and problems. hopefully, the lessons learned from health information infrastructure development activities across the globe can be effectively shared to ease the difficulties of everyone who is working toward these important goals. the vision of the national health information infrastructure is anytime, anywhere health care information at the point of care. the intent to is to create a distributed system, not a centralized national database. patient information would be collected and stored at each care site. when a patient presented for care, the various existing electronic records would be located, collected, integrated, and immediately delivered to allow the provider to have complete and current information upon which to base clinical decisions. in addition, clinical decision support (see chapter ) would be integrated with information delivery. in this way, clinicians could receive reminders of the most recent clinical guidelines and research results during the patient care process, thereby avoiding the need for superhuman memory capabilities to assure the effective practice of medicine. the potential benefits of nhii are both numerous and substantial. perhaps most important are error reduction and improved quality of care. numerous studies have shown that the complexity of present-day medical care results in very frequent errors of both omission and commission. this problem was clearly articulated at the meeting of the institute of medicine: "current practice depends upon the clinical decision making capacity and reliability of autonomous individual practitioners, for classes of problems that routinely exceed the bounds of unaided human cognition" (masys, ) . electronic health information systems can contribute significantly to improving this problem by reminding practitioners about recommended actions at the point of care. this can include both notifications of actions that may have been missed, as well as warnings about planned treatments or procedures that may be harmful or unnecessary. literally dozens of research studies have shown that such reminders improve safety and reduce costs (kass, ; bates, ) . in one such study (bates et al., ) , medication errors were reduced by %. a more recent study by the rand corporation showed that only % of u.s. adults were receiving recommended care (mcglynn et al., ) . the same techniques used to reduce medical errors with electronic health information systems also contribute substantially to ensuring that recommended care is provided. this is becoming increasingly important as the population ages and the prevalence of chronic disease increases. guidelines and reminders also can improve the effectiveness of dissemination of new research results. at present, widespread application of a new research in the clinical setting takes an average of years (balas & boren, ) . patient-specific reminders delivered at the point of care highlighting important new research results could substantially increase the adoption rate. another important contribution of nhii to the research domain is improving the efficiency of clinical trials. at present, most clinical trials require creation of a unique information infrastructure to insure protocol compliance and collect essential research data. with nhii, where every practitioner would have access to a fully functional electronic health record, clinical trials could routinely be implemented through the dissemination of guidelines that specify the research protocol. data collection would occur automatically in the course of administering the protocol, reducing time and costs. in addition, there would be substantial value in analyzing deidentified aggregate data from routine patient care to assess the outcomes of various treatments, and monitor the health of the population. another critical function for nhii is early detection of patterns of disease, particularly early detection of possible bioterrorism. our current system of disease surveillance, which depends on alert clinicians diagnosing and reporting unusual conditions, is both slow and potentially unreliable. most disease reporting still occurs using the postal service, and the information is relayed from local to state to national public health authorities. even when fax or phone is employed, the system still depends on the ability of clinicians to accurately recognize rare and unusual diseases. even assuming such capabilities, individual clinicians cannot discern patterns of disease beyond their sphere of practice. these problems are illustrated by the seven unreported cases of cutaneous anthrax in the new york city area two weeks before the so-called "index" case in florida in the fall of (lipton & johnson, ) . since all the patients were seen by different clinicians, the pattern could not have been evident to any of them even if the diagnosis had immediately been made in every case. wagner et al have elucidated nine categories of requirements for surveillance systems for potential bioterrorism outbreaks-several categories must have immediate electronic reporting to insure early detection (wagner et al., ) . nhii would allow immediate electronic reporting of both relevant clinical events and laboratory results to public health. not only would this be an invaluable aid in early detection of bioterrorism, it would also serve to improve the detection of the much more frequent naturally occurring disease outbreaks. in fact, early results from a number of electronic reporting demonstration projects show that disease outbreaks can routinely be detected sooner than was ever possible using the current system (overhage et al., ) . while early detection has been shown to be a key factor in reducing morbidity and mortality from bioterrorism (kaufmann et al., ) , it will also be extremely helpful in reducing the negative consequences from other disease outbreaks. this aspect of nhii is discussed in more detail in section . . finally, nhii can substantially reduce health-care costs. the inefficiencies and duplication in our present paper-based health care system are enormous. recent study showed that the anticipated nationwide savings from implementing advanced computerized provider order entry (cpoe) systems in the outpatient environment would be $ billion per year (johnston et al., ) , while a related study (walker et al., ) estimated $ billion more is savings from health information exchange (for a total of $ billion per year). substantial additional savings are possible in the inpatient setting-numerous hospitals have reported large net savings from implementation of electronic health records. another example, electronic prescribing, would not only reduce medication errors from transcription, but also drastically decrease the administrative costs of transferring prescription information from provider offices to pharmacies. a more recent analysis concluded that the total efficiency and patient safety savings from nhii would be in range of $ - billion each year (hillestad et al., ) . while detailed studies of the potential savings from comprehensive implementation of nhii, including both electronic health records and effective exchange of health information, are still ongoing, it is clear that the cost reductions will amount to hundreds of billions of dollars each year. it is important to note that much of the savings depends not just on the widespread implementation of electronic health records, but the effective interchange of this information to insure that the complete medical record for every patient is immediately available in every care setting. there are a number of significant barriers and challenges to the development of nhii. perhaps the most important of these relates to protecting the confidentiality of electronic medical records. the public correctly perceives that all efforts to make medical records more accessible for appropriate and authorized purposes simultaneously carry the risk of increased availability for unscrupulous use. while the implementation of the hipaa privacy and security rules (see chapter ) has established nationwide policies for access to medical information, maintaining public confidence requires mechanisms that affirmatively prevent privacy and confidentiality breaches before they occur. development, testing, and implementation of such procedures must be an integral part of any nhii strategy. another important barrier to nhii is the misalignment of financial incentives in the health care system. although the benefits of nhii are substantial, they do not accrue equally across all segments of the system. in particular, the benefits are typically not proportional to the required investments for a number of specific stakeholder groups. perhaps most problematic is the situation for individual and small group health care providers, who are being asked to make substantial allocations of resources to electronic health record systems that mostly benefit others. mechanisms must be found to assure the equitable distribution of nhii benefits in proportion to investments made. while this issue is the subject of continuing study, early results indicate that most of the nhii financial benefit accrues to payers of care. therefore, programs and policies must be established to transfer appropriate savings back to those parties who have expended funds to produce them. one consequence of the misaligned financial incentives is that the return on investment for health information technology needed for nhii is relatively uncertain. while a number of health care institutions, particularly large hospitals, have reported substantial cost improvements from electronic medical record systems, the direct financial benefits are by no means a forgone conclusion, especially for smaller organizations. the existing reimbursement system in the united states does not provide ready access to the substantial capital required by many institutions. for health care organizations operating on extremely thin margins, or even in the red, investments in information technology are impractical regardless of the potential return. in addition, certain legal and regulatory barriers prevent the transfer of funds from those who benefit from health information technology to those who need to invest but have neither the means nor the incentive of substantial returns. laws and regulations designed to prevent fraud and abuse, payments for referrals, and private distribution of disguised "profits" from nonprofit organizations are among those needing review. it is important that mechanisms be found to enable appropriate redistribution of savings generated from health information technology without creating loopholes that would allow abusive practices. another key barrier to nhii is that many of the benefits relate to exchanges of information between multiple health care organizations. the lack of interoperable electronic medical record systems that provide for easy transfer of records from one place to another is a substantial obstacle to achieving the advantages of nhii. also, there is a "first mover disadvantage" in such exchange systems. the largest value is generated when all health care organizations in a community participate electronic information exchange. therefore, if only a few organizations begin the effort, their costs may not be offset by the benefits. a number of steps are currently under way to accelerate the progress towards nhii in the united states. these include establishing standards, fostering collaboration, funding demonstration projects in communities that include careful evaluation, and establishing consensus measures of progress. establishing electronic health record standards that would promote interoperability is the most widely recognized need in health information technology at the present time. within institutions that have implemented specific departmental applications, extensive time and energy is spent developing and maintaining interfaces among the various systems. although much progress has been made in this area by organizations such as health level , even electronic transactions of specific health care data (such as laboratory results) are often problematic due to differing interpretations of the implementation of existing standards. recently, the u.s. government has made substantial progress in this area. ncvhs, the official advisory body on these matters to dhhs, has been studying the issues of both message and content standards for patient medical record information for several years (ncvhs, ) . the consolidated healthcare informatics (chi) initiative recommended five key standards (hl version .x, loinc, dicom, ieee , and ncpdp script) that were adopted for government-wide use in early , followed by more that were added in . in july, , the federal government licensed the comprehensive medical vocabulary known as snomed (systematized nomenclature of medicine; see chapter ), making it available to all u.s. users at no charge. this represents a major step forward in the deployment of vocabulary standards for health information systems. unlike message format standards, such as hl , vocabulary standards are complex and expensive to develop and maintain and therefore require ongoing financial support. deriving the needed funding from end users creates a financial obstacle to deployment of the standard. removing this key barrier to adoption should promote much more widespread use over the next few years. another important project now under way is the joint effort of the institute of medicine and hl to develop a detailed functional definition of the electronic health record (ehr). these functional standards will provide a benchmark for comparison of existing and future ehr systems, and also may be utilized as criteria for possible financial incentives that could be provided to individuals and organizations that implement such systems. the elucidation of a consensus functional definition of the ehr also should help prepare the way for its widespread implementation by engaging all the stakeholders in an extended discussion of its desired capabilities. this functional standardization of the ehr is expected to be followed by the development of a formal interchange format standard (ifs) to be added to hl version . this standard would enable full interoperability of ehr systems through the implementation of an import and export capability to and from the ifs. while it is possible at the present time to exchange complete electronic health records with existing standards, is both difficult and inconvenient. the ifs will greatly simplify the process, making it easy to accomplish the commonly needed operation of transferring an entire electronic medical record from one facility to another. another key standard that is needed involves the representation of guideline recommendations. while the standard known as arden syntax (hl , ; see chapter ) partially addresses this need, many real-world medical care guidelines are too complex to be represented easily in this format. at the present time, the considerable effort required to translate written guidelines and protocols into computer executable form must be repeated at every health care organization wishing to incorporate them in their ehr. development of an effective guideline interchange standard would allow medical knowledge to be encoded once and then distributed widely, greatly increasing the efficiency of the process (peleg at al., ) . collaboration is another important strategy in promoting nhii. to enable the massive changes needed to transform the health care system from its current paper-based operation to the widespread utilization of electronic health information systems, the support of a very large number of organizations and individuals with highly varied agendas is required. gathering and focusing this support requires extensive cooperative efforts and specific mechanisms for insuring that everyone's issues and concerns are expressed, appreciated, and incorporated into the ongoing efforts. this process is greatly aided by a widespread recognition of the serious problems that exist today in the u.s. healthcare system. a number of private collaboration efforts have been established such as the e-health initiative and the national alliance for health information technology (nahit). in the public sector, national health information infrastructure (nhii) has become a focus of activity at dhhs. as part of this effort, the first ever national stakeholders meeting for nhii was convened in mid- to develop a consensus national agenda for moving forward (yasnoff et al., ) . these multiple efforts are having the collective effect of both catalyzing and promoting organizational commitment to nhii. for example, many of the key stakeholders are now forming high-level committees to specifically address nhii issues. for some of these organizations, this represents the first formal recognition that this transformational process is underway and will have a major impact on their activities. it is essential to include all stakeholders in this process. in addition to the traditional groups such as providers, payers, hospitals, health plans, health it vendors, and health informatics professionals, representatives of groups such as consumers (e.g., aarp) and the pharmaceutical industry must be brought into the process. the most concrete and visible strategy for promoting nhii is the encouragement of demonstration projects in communities, including the provision of seed funding. by establishing clear examples of the benefits and advantages of comprehensive health information systems in communities, additional support for widespread implementation can be garnered at the same time that concerns of wary citizens and skeptical policymakers are addressed. there are several important reasons for selecting a community-based strategy for nhii implementation. first and foremost, the existing models of health information infrastructures (e.g., indianapolis and spokane, wa) are based in local communities. this provides proof that it is possible to develop comprehensive electronic health care information exchange systems in these environments. in contrast, there is little or no evidence that such systems can be directly developed on a larger scale. furthermore, increasing the size of informatics projects disproportionately increases their complexity and risk of failure. therefore, keeping projects as small as possible is always a good strategy. since nhii can be created by effectively connecting communities that have developed local health information infrastructures (lhiis), it is not necessary to invoke a direct national approach to achieve the desired end result. a good analogy is the telephone network, which is composed of a large number of local exchanges that are then connected to each other to form community and then national and international networks. another important element in the community approach is the need for trust to overcome confidentiality concerns. medical information is extremely sensitive and its exchange requires a high degree of confidence in everyone involved in the process. the level of trust needed seems most likely to be a product of personal relationships developed over time in a local community and motivated by a common desire to improve health care for everyone located in that area. while the technical implementation of information exchange is non-trivial, it pales in comparison to the challenges of establishing the underlying legal agreements and policy changes that must precede it. for example, when indianapolis implemented sharing of patient information in hospital emergency rooms throughout the area, as many as institutional lawyers needed to agree on the same contractual language (overhage, ) . the community approach also benefits from the fact that the vast majority of health care is delivered locally. while people do travel extensively, occasionally requiring medical care while away from home, and there are few out-of-town consultations for difficult and unusual medical problems, for the most part people receive their health care in the community in which they reside. the local nature of medical care results in a natural interest of community members in maintaining and improving the quality and efficiency of their local health care system. for the same reasons, it is difficult to motivate interest in improving health care beyond the community level. focusing nhii efforts on one community at a time also keeps the implementation problem more reasonable in its scope. it is much more feasible to enable health information interchange among a few dozen hospitals and a few hundred or even a few thousand providers than to consider such a task for a large region or the whole country. this also allows for customized approaches sensitive to the specific needs of each local community. the problems and issues of medical care in a densely populated urban area are clearly vastly different than in a rural environment. similarly, other demographic and organizational differences as well as the presence of specific highly specialized medical care institutions make each community's health care system unique. a local approach to hii development allows all these complex and varied factors to be considered and addressed, and respects the reality of the american political landscape, which gives high priority to local controls. the community-based approach to hii development also benefits from the establishment of national standards. the same standards that allow effective interchange of information between communities nationwide can also greatly facilitate establishing effective communication of medical information within a community. in fact, by encouraging (and even requiring) communities to utilize national standards in building their own lhiis, the later interconnection of those systems to provide nationwide access to medical care information becomes a much simpler and easier process. demonstration projects also are needed to develop and verify a replicable strategy for lhii development. while there are a small number of existing examples of lhii systems, no organization or group has yet demonstrated the ability to reliably and successfully establish such systems in multiple communities. from the efforts of demonstration projects in numerous communities, it should be possible to define a set of strategies that can be applied repeatedly across the nation. seed funding is essential in the development of lhii systems. while health care in united states is a huge industry, spending approximately $ . trillion each year and representing % of the gdp, shifting any of the existing funds into substantial it investments is problematic. the beneficiaries of all the existing expenditures seem very likely to strongly oppose any such efforts. on the other hand, once initial investments begin to generate the expected substantial savings, it should be possible to develop mechanisms to channel those savings into expanding and enhancing lhii systems. careful monitoring of the costs and benefits of local health information interchange systems will be needed to verify the practicality of this approach to funding and sustaining these projects. finally, it is important to assess and understand the technical challenges and solutions applied to lhii demonstration projects. while technical obstacles are usually not serious in terms of impeding progress, understanding and disseminating the most effective solutions can result in smoother implementation as experience is gained throughout the nation. the last element in the strategy for promoting a complex and lengthy project such as nhii is careful measurement of progress. the measures used to gauge progress define the end state and therefore must be chosen with care. measures may also be viewed as the initial surrogate for detailed requirements. progress measures should have certain key features. first, they should be sufficiently sensitive so that their values change at a reasonable rate (a measure that only changes value after five years will not be particularly helpful). second, the measures must be comprehensive enough to reflect activities that impact most of the stakeholders and activities needing change. this ensures that efforts in every area will be reflected in improved measures. third, the measures must be meaningful to policymakers. fourth, periodic determinations of the current values of the measures should be easy so that the measurement process does not detract from the actual work. finally, the totality of the measures must reflect the desired end state so that when the goals for all the measures are attained, the project is complete. a number of different types or dimensions of measures for nhii progress are possible. aggregate measures assess nhii progress over the entire nation. examples include the percentage of the population covered by an lhii and the percentage of health care personnel whose training occurs in institutions that utilize electronic health record systems. another type of measure is based on the setting of care. progress in implementation of electronic health record systems in the inpatient, outpatient, long-term care, home, and community environments could clearly be part of an nhii measurement program. yet another dimension is health care functions performed using information systems support, including, for example, registration systems, decision support, cpoe, and community health information exchange. it is also important to assess progress with respect to the semantic encoding of electronic health records. clearly, there is a progression from the electronic exchange of images of documents, where the content is only readable by the end user viewing the image, to fully encoded electronic health records where all the information is indexed and accessible in machine-readable form using standards. finally, progress can also be benchmarked based on usage of electronic health record systems by health care professionals. the transition from paper records to available electronic records to fully used electronic records is an important signal with respect to the success of nhii activities. to illustrate some of the informatics challenges inherent in nhii, the example of its application to homeland security will be used. bioterrorism preparedness in particular is now a key national priority, especially following the anthrax attacks that occurred in the fall of . early detection of bioterrorism is critical to minimize morbidity and mortality. this is because, unlike other terrorist attacks, bioterrorism is usually silent at first. its consequences are usually the first evidence that an attack has occurred. traditional public health surveillance depends on alert clinicians reporting unusual diseases and conditions. however, it is difficult for clinicians to detect rare and unusual diseases since they are neither familiar with their manifestations nor suspicious of the possibility of an attack. also, it is often difficult to differentiate potential bioterrorism from more common and benign manifestations of illness. this is clearly illustrated by the seven cases of cutaneous anthrax that occurred in the new york city area two weeks prior to the "index " case in florida the fall of (lipton & johnson, ) . all these cases presented to different clinicians, none of whom recognized the diagnosis of anthrax with sufficient confidence to notify any public health authority. furthermore, such a pattern involving similar cases presenting to multiple clinicians could not possibly be detected by any of them. it seems likely that had all seven of these patients utilized the same provider, the immediately evident pattern of unusual signs and symptoms alone would have been sufficient to result in an immediate notification of public health authorities even in the absence of any diagnosis. traditional public health surveillance also has significant delays. much routine reporting is still done via postcard and fax to the local health department, and further delays occur before information is collated, analyzed, and reported to state and finally to federal authorities. there is also an obvious need for a carefully coordinated response after a bioterrorism event is detected. health officials, in collaboration with other emergency response agencies, must carefully assess and manage health care assets and ensure rapid deployment of backup resources. also, the substantial increase in workload created from such an incident must be distributed effectively among available hospitals, clinics, and laboratories, often including facilities outside the affected area. the vision for the application of nhii to homeland security involves both early detection of bioterrorism and the response to such an event. clinical information relevant to public health would be reported electronically in near real-time. this would include clinical lab results, emergency room chief complaints, relevant syndromes (e.g., flu-like illness), and unusual signs, symptoms, or diagnoses. by generating these electronic reports automatically from electronic health record systems, the administrative reporting burden currently placed on clinicians would be eliminated. in addition, the specific diseases and conditions reported could be dynamically adjusted in response to an actual incident or even information related to specific threats. this latter capability would be extremely helpful in carefully tracking the development of an event from its early stages. nhii could also provide much more effective medical care resource management in response to events. this could include automatic reporting of all available resources so they could be allocated rapidly and efficiently, immediate operational visibility of all health care assets, and effective balancing of the tremendous surge in demand for medical care services. this would also greatly improve decision making about deployment of backup resources. using nhii for these bioterrorism preparedness functions avoids developing a separate, very expensive infrastructure dedicated to these rare events. as previously stated, the benefits of nhii are substantial and fully justify its creation even without these bioterrorism preparedness capabilities, which would be an added bonus. furthermore, the same infrastructure that serves as an early detection system for bioterrorism also will allow earlier and more sensitive detection of routine naturally occurring disease outbreaks (which are much more common) as well as better management of health care resources in other disaster situations. the application of nhii to homeland security involves a number of difficult informatics challenges. first, this activity requires participation from a very wide range of both public and private organizations. this includes all levels of government and organizations that have not had significant prior interactions with the health care system such as agriculture, police, fire, and animal health. needless to say, these organizations have divergent objectives and cultures that do not necessarily mesh easily. health and law enforcement in particular have a significantly different view of a bioterrorism incident. for example, an item that is considered a "specimen" in the health care system may be regarded as "evidence" by law enforcement. naturally, this wide variety of organizations has incompatible information systems, since for the most part they were designed and deployed without consideration for the issues raised by bioterrorism. not only do they have discordant design objectives, but they lack standardized terminology and messages to facilitate electronic information exchange. furthermore, there are serious policy conflicts among these various organizations, for example, with respect to access to information. in the health care system, access to information is generally regarded as desirable, whereas in law enforcement it must be carefully protected to maintain the integrity of criminal investigations. complicating these organizational, cultural, and information systems issues, bioterrorism preparedness has an ambiguous governance structure. many agencies and organizations have legitimate and overlapping authority and responsibility, so there is often no single clear path to resolve conflicting issues. therefore, a high degree of collaboration and collegiality is required, with extensive pre-event planning so that roles and responsibilities are clarified prior to any emergency. within this complex environment, there is also a need for new types of systems with functions that have never before been performed. bioterrorism preparedness results in new requirements for early disease detection and coordination of the health care system. precisely because these requirements are new, there are few (if any) existing systems that have similar functions. therefore careful consideration to design requirements of bioterrorism preparedness systems is essential to ensure success. most importantly, there is an urgent need for interdisciplinary communication among an even larger number of specialty areas than is typically the case with health information systems. all participants must recognize that each domain has its own specific terminology and operational approaches. as previously mentioned in the public health informatics example, the interlocutor function is vital. since it is highly unlikely that any single person will be able to span all or even most of the varied disciplinary areas, everyone on the team must make a special effort to learn the vocabulary used by others. as a result of these extensive and difficult informatics challenges, there are few operational information systems supporting bioterrorism preparedness. it is interesting to note that all the existing systems developed to date are local. this is most likely a consequence of the same issues previously delineated in the discussion of the advantages of community-based strategies for nhii development. one such system performs automated electronic lab reporting in indianapolis (overhage et al., ) . the development of this system was led by the same active informatics group that developed the lhii in the same area. nevertheless, it took several years of persistent and difficult efforts to overcome the technical, organizational, and legal issues involved. for example, even though all laboratories submitted data in "standard" hl format, it turned out that many of them were interpreting the standard in such a way that the electronic transactions could not be effectively processed by the recipient system. to address this problem, extensive reworking of the software that generated these transactions was required for many of the participating laboratories. another example of a bioterrorism preparedness system involves emergency room chief complaint reporting in pittsburgh (tsui et al., ) . this is a collaborative effort of multiple institutions with existing electronic medical record systems. it has also been led by an active informatics group that has worked long and hard to overcome technical, organizational, and legal challenges. it provides a near real-time "dashboard" for showing the incidence rates of specific types of syndromes, such as gastrointestinal and respiratory. this information is very useful for monitoring the patterns of diseases presenting to the area's emergency departments. note that both of these systems were built upon extensive prior work done by existing informatics groups. they also took advantage of existing local health information infrastructures that provided either available or least accessible electronic data streams. in spite of these advantages, it is clear from these and other efforts that the challenges in building bioterrorism preparedness systems are immense. however, having an existing health information infrastructure appears to be a key prerequisite. such an infrastructure implies the existence of a capable informatics group and available electronic health data in the community. public health informatics may be viewed as the application of biomedical informatics to populations. in a sense, it is the ultimate evolution of biomedical informatics, which has traditionally focused on applications related to individual patients. public health informatics highlights the potential of the health informatics disciplines as a group to integrate information from the molecular to the population level. public health informatics and the development of health information infrastructures are closely related. public health informatics deals with public health applications, whereas health information infrastructures are population-level applications primarily focused on medical care. while the information from these two areas overlaps, the orientation of both is the community rather than the individual. public health and health care have not traditionally interacted as closely as they should. in a larger sense, both really focus on the health of communities-public health does this directly, while the medical care system does it one patient at a time. however, it is now clear that medical care must also focus on the community to integrate the effective delivery of services across all care settings for all individuals. the informatics challenges inherent in both public health informatics and the development of health information infrastructures are immense. they include the challenge of large numbers of different types of organizations including government at all levels. this results in cultural, strategic, and personnel challenges. the legal issues involved in interinstitutional information systems, especially with regard to information sharing, can be daunting. finally, communications challenges are particularly difficult because of the large number of areas of expertise represented, including those that go beyond the health care domain (e.g., law enforcement). to deal with these communication issues, the interlocutor function is particularly critical. however, the effort required to address the challenges of public health informatics and health information infrastructures is worthwhile because the potential benefits are so substantial. effective information systems in these domains can help to assure effective prevention, high-quality care, and minimization of medical errors. in addition to the resultant decreases in both morbidity and mortality, these systems also have the potential to save hundreds of billions of dollars in both direct and indirect costs. it has been previously noted that one of the key differences between public health informatics and other informatics disciplines is that it includes interventions beyond the medical care system, and is not limited to medical and surgical treatments (yasnoff et al., ) . so despite the focus of most current public health informatics activities on population-based extensions of the medical care system (leading to the orientation of this chapter), applications beyond this scope are both possible and desirable. indeed, the phenomenal contributions to health made by the hygienic movement of the th and early th centuries suggest the power of large-scale environmental, legislative, and social changes to promote human health (rosen, ) . public health informatics must explore these dimensions as energetically as those associated with prevention and clinical care at the individual level. the effective application of informatics to populations through its use in both public health and the development of health information infrastructures is a key challenge of the st century. it is a challenge we must accept, understand, and overcome if we want to create an efficient and effective health care system as well as truly healthy communities for all. questions for further study: while some of the particulars are a little dated, this accessible document shows how public health professionals approach informatics problems can electronic medical record systems transform health care? potential health benefits a consensus action agenda for achieving the national health information infrastructure public health informatics: how information-age technology can strengthen public health public health for informaticians public health informatics and information systems the value of healthcare information exchange and interoperability a consensus action agenda for achieving the national health information infrastructure public health informatics: improving and transforming public health in the information age what are the current and potential effects of a) the genomics revolution; and b) / on public health informatics? how can the successful model of immunization registries be used in other domains of public health (be specific about those domains)? how might it fail in others? why? fourteen percent of the us gdp is spent on medical care (including public health). how could public health informatics help use those monies more efficiently? or lower the figure absolutely? compare and contrast the database desiderata for clinical versus public health information systems. explain it from non-technical and technical perspectives make the case for and against investing billions in an nhii what organizational options would you consider if you were beginning the development of a local health information infrastructure? what are the pros and cons of each? how would you proceed with making a decision about which one to use? phi) involves the application of information technology in any manner that improves or promotes human health, does this necessarily involve a human "user" that interacts with the phi application? for example, could the information technology underlying anti-lock braking systems be considered a public health informatics application? key: cord- -gyuldf a authors: ostroff, stephen m. title: the spread of disease in the th century and lessons for the st century date: - - journal: travel medicine doi: . /b - - - - . - sha: doc_id: cord_uid: gyuldf a nan influenza, images of the pandemic have resurfaced, including makeshift hospitals in gymnasiums and armories, masked security personnel, and corpses littering the streets. as a result of this epidemic, life expectancy temporarily plummeted all over the world; in the united states life expectancy decreased from to years. although no one knows for sure how the spanish flu spread, travel surely contributed. we were in the midst of world war i. mass displacements and malnutrition among civilian populations affected by the war were common. ships carried thousands of soldiers back and forth from the americas to europe, and troops were moving all around the continent. this was the perfect recipe for a disease explosion. many accounts suggest that the virus first appeared in the united states midwest, moved to the east coast, then from america to europe along with the troops, alit in spain, and spread exponentially from there. all this was at a time when travel was still relatively slow. in , that journey took months; today it would take hours. like its filovirus cousin ebola, marburg virus is an african pathogen that causes severe hemorrhagic fever. yet in it was first identified not in africa, but in a small university town in germany (which is how the virus got its name) (slenczka, ) . how did it get there? the virus hopscotched from africa to england to germany, in a group of african monkeys whose kidneys were to be used for tissue culture purposes. a strange disease then occurred among workers who handled the monkeys or their tissues in both germany and yugoslavia, killing almost a fourth of those infected. a similar episode in the late s in washington dc (involving an ebola virus variant of no obvious pathogenicity to humans) occurred in cynomolgus monkeys and their handlers originating from the philippines (jahrling et al., ) . it prompted the international best seller the hot zone by richard preston, vaulting emerging infectious diseases to the forefront of public consciousness (preston, ) . in , a new cause of pneumonia was recognized among those who traveled to an american legion convention in philadelphia, pennsylvania (fraser et al., ) . this illness, known ever since as legionnaires disease, had as its source the cooling system of an upscale, downtown hotel named the bellevue stratford. apropos for a disease that got its start at a convention, many subsequent legionnaires disease outbreaks have been associated with travel settings. among the more common are hotels; others include spas, cruise ships, and flower shows (fields, benson, & besser, ) . travel has played a prominent role in the second devastating epidemic of the th century. this, of course, is acquired immune deficiency syndrome (aids) caused by the human immunodeficiency virus. this disease was first identified in (gottlieb et al., ) . while the origin of aids is considered to involve a virus that jumped the species barrier from great apes to humans, its subsequent spread was greatly assisted by human movement. although details remain murky, the disease clearly spread from its origins in central africa by road, hitch hiking with long-haul truckers. movement to the western hemisphere may have been facilitated through persons who went to africa like workers from haiti and soldiers from cuba. north american visitors to haiti, which was then a popular tourist destination, carried the disease from the caribbean back home with them. once hiv emerged in places like thailand, its global spread was furthered by the large-scale sex tourism industry of the s and s in that country. the international spread of hiv could be documented because of clades (or subtypes) of the virus, which appeared in different locations (mccutchan, ) . in a number of small, isolated locations like pacific island countries, the first appearance of hiv was often linked to locals who had traveled abroad for school or work. the long latency of hiv before the appearance of symptoms gave ample opportunity for this virus to spread undetected via population movements and tourism. unfortunately, the disease burden of hiv continues to mount. at last count, more than million persons have been cumulatively infected and more than million have died (un aids, ) . south america was cholera-free for almost the entire th century. but in , the disease suddenly appeared in several areas of coastal peru almost simultaneously (swerdlow et al., ) . from there, cholera quickly spread throughout the entire continent of south america, into central america, and as far north as mexico, over a brief period of less than two years. almost . million cases were recorded over the next decade, with close to , fatalities (pan american health organization, . it took many years and billions of dollars in sanitation improvements to bring the disease under control in affected areas. although some have suggested that this outbreak was a natural event related to movement of the organism on sea-currents, a more likely explanation is that it was introduced in ballast released from a ship traveling from a cholera-endemic area. its subsequent spread was aided by the absence of population immunity, but it was travelers and movement of goods that rapidly spread the organism. infections linked to air travel and to foods were well documented. the last major infectious disease event of the th century, and the first naturally occurring ones of the st century, illustrate the powerful role movement and travel now play in the emergence of infectious diseases. in august of , a cluster of encephalitis cases was identified in new york city. this human cluster occurred at the same time bird die-offs were reported in the region. investigations found that the human and avian outbreaks were linked and the causative agent was identified as west nile virus, an arbovirus never previously seen in the western hemisphere (asnis, conetta, texeira, waldman, & sampson, ) . over the next five years, the virus methodically marched across north america, reaching the pacific coast in . in its wake, it has caused hundreds of thousands of infections, almost , illnesses, and close to , deaths in the united states and canada. it has reappeared annually in all areas that it has invaded, suggesting it is a permanently entrenched part of the microbial flora in north america. it has also progressively moved south and has been identified in central america, the caribbean, and as far south as argentina. how west nile virus moved from its natural range (africa, the middle east, europe, and western asia) to north america remains a mystery. studies showed that the virus found in new york city was closely related to one identified a year earlier in the middle east, suggesting this as the source of introduction (lanciotti et al., ) . all subsequent west nile viruses in north america have been clonal descendants of the new york strain, suggesting a single discreet introduction. possible explanations include movement of infected mosquito vectors on a plane or in cargo or movement of an infected bird (intentionally or naturally), animal, or human. the latter two explanations are less likely, as mammalian west nile viremias tend not to be high enough to allow back-transmission to biting mosquitoes. regardless, movement of something from the old world to the new world was surely involved. bird movement is thought to explain the steady westward migration of the virus. travel-associated disease has been a feature of west nile since , being reported in persons traveling to north america and in north americans traveling from uninfected to infected areas. this episode serves as a stark reminder of how easy it now is for vector-borne pathogens considered to be geographically specific to move to new locations. in the spring of , the annual pilgrimage (hajj) to mecca took place. this event is the single largest annual gathering in the world; millions of travelers from throughout the muslim world participate. pathogens have been known to also make the pilgrimage, causing outbreaks during the event and disseminating from the event. the and hajjs were no exception. the pathogen was neisseria meningitidis w . as a result of previous episodes of meningococcal disease at the hajj, the saudi government required all pilgrims to be vaccinated. however, while the u.s. vaccine produced immunity against four types (a,c,w , and y), the european vaccine only protected against types a and c. after the event, pilgrims returned home carrying the hajj-specific w strain and sparked outbreaks (in themselves or in contacts) in at least countries, mostly locations where the pilgrims had not been protected against w . these outbreaks resulted in more than cases of disease in both and , with a mortality rate of approximately % (world health organization, ) . there is strong evidence that the dissemination of w from the hajj into a number of locations, especially the african meningitis belt, altered the usual distribution of circulating meningococcal types over the next several years (traore et al., ) . severe acute respiratory syndrome (sars), which was recognized in early , was through-and-through a travel-related disease. the pivotal event occurred on the weekend of february st, when a medical professor from guangdong china, and his wife, traveled to hong kong to attend a family wedding. this professor had been caring for persons with a mysterious new disease, and despite not feeling well, elected to attend the wedding. the couple stayed on the th floor of the metropole hotel in hong kong. although the professor attended the wedding, he was otherwise too sick to do much else while in the hotel. he died in a hong kong hospital shortly after the wedding (centers for disease control and prevention, ) .the majority of subsequent sars outbreaks can be directly linked back to ten other guests who stayed at the hotel (all but one on the th floor) that same weekend. after they were exposed in unknown fashion, these guests flew to canada, the united states, ireland, singapore, and vietnam, while some remained in hong kong. in several instances, prolonged chains of transmission involving hundreds of cases were the result. movement of infected persons resulted in a small outbreak in thailand and of diagnosed illness in germany. air travel from hong kong caused the spread of disease to locations in mainland china and taiwan. beijing was hit especially hard. ultimately , cases and fatalities were diagnosed in different countries (world health organization, a) . transmission was documented on several transportation modes, including commercial planes, taxis, and trains. absent specific medical interventions, the disease was eventually brought under control through a concerted global public health effort that included intensive surveillance and screening procedures, isolation and quarantine, travel restrictions, and barrier precautions. the outbreak resulted in severe disruptions to the global economy, to travel, and to commerce (world health organization, b) . every part of the world was affected, either directly or indirectly. the last documented sars case was in ; the potential for reintroduction and subsequent spread through travel is unknown. among today's infectious disease threats, none has engendered more concern than the potential for a pandemic due to the emergence of human disease related to avian influenza subtype a (h n ). human infection was first recognized in in hong kong, when cases and six fatalities occurred (yuen et al., ) . at that time, the poultry and human outbreaks were aborted through the destruction of all poultry in the territory. in , h n reemerged in vietnam and china. since then, the virus has spread widely, mostly through poultry movement and in migratory birds. movement of the virus in smuggled birds has been documented (van born et al., ) . avian disease due to h n has now appeared in more than countries in asia, europe, and africa (world health organization, a), either killing or requiring the destruction of hundreds of millions of birds. in humans, h n has caused a severe disease marked by fulminate respiratory failure and pneumonia (who, ) . more than human cases have been confirmed by the world health organization in countries, with the largest numbers in vietnam, indonesia, thailand, china, and egypt (world health organization). the median age of affected persons has been years (range months to years), and overall mortality has been close to % (world health organization, b) .these factors qualify this virus as one with high pandemic potential. it has already met two of the three criteria generally associated with a pandemic strain. first, it is an unusual influenza subtype, never having been associated with human disease prior to . second, it causes unusually severe disease. to date, the third criterion, that the virus easily spreads from person-to-person, has not been met. virtually all human cases have had direct or close contact with sick and dying poultry. although several clusters either confirmed as, or strongly suggesting, person-to-person transmission have been identified, none have shown sustained human-to-human spread (wong & yuen, ) . if this occurs through virus mutation or recombination, a pandemic would be virtually assured, since there is virtually no population immunity in humans against the h subtype. although no one knows how severe the pandemic would be, h n human disease presently exhibits some of the characteristics seen with the spanish flu, especially its predilection to affect healthy young adults. health authorities around the world have voiced concern that h n could trigger a type pandemic, even though we have tools at our disposal like antiviral drugs and vaccines that were unavailable a century ago. however, the ability for rapid global dissemination of an easily transmissible strain (a la sars) through travelers also did not exist a century ago. while to date travelers have not figured in the epidemiology of h n human disease, this situation is unlikely to continue, even given the present limited person-to-person spread. should the virus acquire the capacity for such spread, travel will without question be a critical factor in its dissemination. in spite of the medical and technologic advances of the last century, there is every reason to think that the patterns of infectious disease emergence seen in the th century will continue to be replicated in the st century. if anything, movement will play an even more prominent contributing role to this phenomenon, resulting in widespread, multinational outbreaks a la meningococcal disease from the hajj and sars. this is because the number of people traveling, the volume of international commerce, the size of conveyances, and their speed, will continue to rise. microbes will continue to be unwitting hitch-hikers on this global (and may be even extra-terrestrial) merry-go-round. how we deal with these trends, whether through improved global monitoring of travelers, improved detection methods, and better prevention and control measures, will in large part determine whether we humans are able to maintain our equilibrium with the ever-changing microbes that cohabit our world. the spread of disease in the th century the west nile virus outbreak of in new york: the flushing hospital experience update: outbreak of severe acute respiratory syndrome -worldwide human plague four cases legionella and legionnaires' disease: years of investigation legionnaires' disease: description of an epidemic of pneumonia pneumocystis carinii pneumonia and mucosal candidiasis in previously health homosexual men: evidence of a new acquired cellular immunodeficiency preliminary report: isolation of ebola virus from monkeys imported to usa plague in san francisco origin of the west nile virus responsible for an outbreak of encephalitis in the northeastern united states understanding the genetic diversity of hiv- available at: www the marburg virus outbreak of and subsequent episodes waterborne transmission of epidemic cholera in trujillo, peru: lessons for a continent at risk influenza: the mother of all pandemics consultation on human influenza a/h . avian influenza a(h n ) infection in humans the rise and fall of epidemic neisseria meningitidis serogroup w meningitis in burkino faso report on the global aids pandemic (a unaids th anniversary special edition) highly pathogenic h n influenza virus in smuggled thai eagles cumulative number of reported cases of severe acute respiratory syndrome (sars). geneva: world health organization world: areas reporting confirmed occurrence of h n avian influenza in poultry and wild birds since . geneva: world health organization epidemiology of who-confirmed human cases of avian influenza a(h n ) infection cumulative number of confirmed human cases of avian influenza a/(h n ) reported to who. geneva: world health organization clinical features and rapid viral diagnosis of human disease associated with avian influenza a(h n ) virus key: cord- - epvg authors: kearney, alexis; pettit, catherine title: introduction to biological agents and pandemics date: - - journal: ciottone's disaster medicine doi: . /b - - - - . - sha: doc_id: cord_uid: epvg nan alexis kearney and catherine pettit biological agents have been used as weapons since antiquity. in bc solon of athens poisoned the wells of his adversaries with hellebore-a purgative herb-during the siege of krissa. similarly the assyrians contaminated the wells of their enemies with rye ergot. [ ] [ ] [ ] in the fourteenth century corpses of plague victims were hurled over walls to infect enemies, and in the seventeenth and eighteenth centuries smallpox-laden blankets were used to target native americans. biological agents played a role in military offenses into the twentieth century and have been used in terrorist actions around the world. in president richard nixon halted offensive biological and toxin research and production in the united states. stockpiles of various biological agents and toxins, including bacillus anthracis, botulinum toxin, and francisella tularensis, were subsequently destroyed. in the united states, the united kingdom, the ussr, and more than other nations ratified the biological weapons convention (bwc). the bwc prohibits the development, production, and stockpiling of weapons of mass destruction. , despite this, during the last years, multiple signatory nations have violated the pact set forth by the bwc. additionally, there has been a rise in the use of biological agents in terrorist attacks, including the anthrax attacks in , which resulted in few deaths but widespread fear. the u.s. centers for disease control and prevention have organized biological weapons into three categories (table - ) . category a, or high-priority agents, include organisms that can be easily disseminated, result in high mortality, and have the potential to cause significant public panic. anthrax, botulism, smallpox, tularemia, and the viral hemorrhagic fevers are included in category a. category b agents, including food and water safety threats, are moderately easy to disseminate. although mortality rates due to these agents are lower they may result in significant morbidity. finally, category c agents are considered emerging pathogens. these agents may be adapted in the future to take full advantage of their pathogenicity, availability, and lethality. in general, biological weapons are characterized by low visibility, high potency, and relative ease of delivery and dissemination. the agents must also be easily obtained, cultured, or reproduced and be relatively stable in the environment. surveillance a good surveillance system is essential to any public health effort and is recognized as the single most important factor in identifying events of global concern. historically, surveillance systems relied on manual reporting of notifiable diseases or suspicious cases from clinicians, hospitals, and laboratories. there has been a shift to focus more on automated surveillance of readily available data to improve the timeliness, sensitivity, and specificity of the system. the exponential increase in social media use and availability of web-based applications has added another potential surveillance domain, which is being utilized for research and communication. in an effort to better identify and track potential outbreaks related to infectious diseases, both naturally occurring and those related to biowarfare and terrorism, public health practitioners developed surveillance systems designed to analyze routinely collected health information. syndromic surveillance, as it has come to be known, includes a wide range of surveillance activities, from monitoring over-the-counter medication purchases to tracking discharge diagnoses from emergency departments and analyzing internet search queries. , true syndromic surveillance monitors syndromes-or constellations of symptoms-that may represent the prodromes of biological agents or emerging epidemics. it relies on the automated analysis of routinely collected data to detect aberrancies in expected trends in near real-time. this process has been streamlined with the increased availability of electronically collected and exchanged data. it is frequently used in conjunction with alternative surveillance methods and verification techniques to improve outbreak detection. the goal of syndromic surveillance systems is to enable more timely detection of outbreaks by identifying trends before these patterns are recognized clinically and a formal diagnosis is made. this allows a more rapid response, ultimately decreasing morbidity and mortality. once an outbreak is suspected public health responders must proceed with a thorough epidemiological investigation to further describe the outbreak and implement control measures. although syndromic surveillance complements the more timeconsuming and burdensome conventional surveillance systems that rely on physician and laboratory reporting, there are significant limitations, including frequent false alarms. if the system is sensitive enough to detect small outbreaks, it may result in false alarms, which consume resources and make it difficult to separate true outbreaks from daily variation. , , additionally, the ability of a surveillance system to detect an outbreak depends on a variety of factors, including the size of the outbreak, pattern of population dispersion following exposure to the agent, and data sources and syndrome definitions used in the analysis. methods have been developed to analyze data using time and time-space relationships to take into account baseline variability; however, these methods have not been standardized across surveillance systems. [ ] [ ] [ ] each community utilizing syndromic surveillance must ultimately set its own threshold level for activation. these thresholds should be set using historical data, hazard vulnerability analysis, and risk-benefit calculations for each syndrome. environmental surveillance systems rely on the remote detection of aerosol clouds or point detection systems to collect and analyze data. remote detection systems identify and analyze the components of clouds, subsequently transmitting that information to public health personnel on the ground. point detection systems sample an environmental area using high speed particle concentration methods and rapid diagnostic modalities to detect and identify potential agents. in the department of homeland security launched biowatch, an environmental air sampling program currently under way in more than u.s. cities, with the goal of facilitating detection of specific agents that could be aerosolized and used in a biological attack. bio-watch is intended to complement current surveillance activities at the state and local levels. however, in its current design, it is unlikely that the biowatch system will result in more timely detection of biological agents unless there is a large-scale aerosol attack in a location monitored by biowatch using biological agents detectable by the system. since the turn of the century we have faced numerous outbreaks-both naturally occurring and intentional-that have changed the landscape of public health surveillance and preparedness. in b. anthracis spores were sent to various locations around the united states, resulting in cases and deaths. this was followed by the epidemic of severe acute respiratory syndrome (sars) in , an outbreak of novel influenza a h n in , and in middle east respiratory syndrome (mers-cov), which continues to spread. since the anthrax attacks, a significant amount of money and resources has been poured into improving public health infrastructure. however, despite this focus, it is unclear if improvements have actually been achieved. in part this stems from conflicting goals, shifting priorities, and the lack of a clear definition of what it means to be prepared. , ultimately reactionary response programs have less impact than hardening all hazards public health infrastructure, which has been neglected for decades. in a diverse expert panel convened by the rand corporation developed the following definition of public health emergency preparedness (phep) in order to strengthen accountability and streamline preparedness efforts. they define phep as the capability of the public health and health care systems, communities, and individuals, to prevent, protect against, quickly second highest priority agents include those that are moderately easy to disseminate, result in moderate morbidity rates and low mortality rates, and require specific enhancements of the cdc's diagnostic capacity and enhanced disease surveillance. brucellosis (brucella species) epsilon toxin of clostridium perfringens food safety threats (e.g., salmonella species, escherichia coli o :h , shigella) glanders (burkholderia mallei) melioidosis (burkholderia pseudomallei) psittacosis (chlamydia psittaci) q fever (coxiella burnetii) ricin toxin from ricinus communis (castor beans) staphylococcal enterotoxin b typhus fever (rickettsia prowazekii) viral encephalitis (e.g., venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis) water safety threats (e.g., vibrio cholerae, cryptosporidium parvum) category c third highest priority agents include emerging pathogens that could be engineered for mass dissemination in the future because of availability, ease of production and dissemination, and potential for high morbidity and mortality rates and major health impact. emerging infectious diseases, such as nipah virus and hantavirus respond to, and recover from health emergencies, particularly those whose scale, timing, or unpredictability threatens to overwhelm routine capabilities. preparedness involves a coordinated and continuous process of planning and implementation that relies on measuring performance and taking corrective action. the panel further argued that phep must cover a full range of activities, including prevention, mitigation, response, and recovery. additionally, it must take into account not only capacity (i.e., infrastructure, trained personnel), but also capability-the ability to implement preparedness plans in real time. large-scale public health emergencies occur infrequently; as a result, it is difficult to execute, assess, and refine preparedness plans based on experience. furthermore there is no universally agreed upon standard of preparedness. federal, state, and local organizations have all established their own conflicting requirements, and there are few data to support one set of standards over another. written assessments and exercises have frequently been used to assess preparedness. although written assessments are easily administered to large groups of people and the data obtained are generally easier to analyze, they frequently focus on the capacity as opposed to the capabilities of a system. although important, these factors do not ensure an effective emergency response. exercises, in contrast, may be discussion based or operations based and generally provide a more realistic view of an organization's capability to mobilize resources and infrastructure. however, real-time exercises are rarely evaluated with standard metrics to identify and address performance gaps. moving forward it is essential to incorporate evaluations into routine public health functions. in public health practitioners in both los angeles and new york city embedded assessments into influenza a h n vaccination campaigns. as a result, invaluable information was gained about the optimal placement of points of dispensing influenza vaccines within a community and the potential for scaling up electronic immunization information systems to better track immunization progress and manage supply and distribution of vaccines in a pandemic. , although it may be difficult to identify questions and develop research protocols in the midst of an emergency, the time between events can serve as an opportunity to engage leaders, develop template protocols, and prioritize areas for investigation. summary ultimately, leaders must make decisions regarding public health responses with imperfect, limited data. the information provided by surveillance systems, used in conjunction with clinical data, will ultimately help public health practitioners identify an etiologic agent. as preparedness strategies become more standardized and evidence based, our ability to respond to public health emergencies, including biological attacks, will improve. each chapter in section will cover a specific biological agent. the authors will outline what is known about the agent currently and, from this, attempt to extrapolate how this agent might be used in a bioterrorism attack. medical management of biological casualties handbook biological warfare and bioterrorism: a historical review biologic warfare: a historical perspective current concepts in the management of biologic and chemical warfare casualties biosurveillance: a review and update systematic review: surveillance systems for early detection of bioterrorism-related diseases syndromic surveillance and bioterrorism-related epidemics what is syndromic surveillance? real-time public health surveillance for emergency preparedness biowatch and public health surveillance: evaluating systems for the early detection of biological threats infectious agents of bioterrorism: a review for emergency physicians conceptualizing and defining public health preparedness assessing public health emergency preparedness: concepts, tools, and challenges research as a part of public health emergency response incorporating research and evaluation into pandemic influenza vaccination preparedness and response efficiency of points of dispensing for influenza a(h n )pdm vaccination distribution of pandemic influenza vaccine and reporting of doses administered key: cord- - j fl authors: afolabi, michael olusegun title: pandemic influenza: a comparative ethical approach date: - - journal: public health disasters: a global ethical framework doi: . / - - - - _ sha: doc_id: cord_uid: j fl community-networks such as families and schools may foster and propagate some types of public health disasters. for such disasters, a communitarian-oriented ethical lens offers useful perspectives into the underlying relational nexus that favors the spread of infection. this chapter compares two traditional bioethical lenses—the communitarian and care ethics framework—vis-à-vis their capacities to engage the moral quandaries elicited by pandemic influenza. it argues that these quandaries preclude the analytical lens of ethical prisms that are individual-oriented but warrant a people-oriented approach. adopting this dual approach offers both a contrastive and a complementary way of rethinking the underlying socioethical tensions elicited by pandemic influenza in particular and other public health disasters generally. contemporary healthcare constitutes an instinctual and institutional response to the multifaceted cycles of health, illness, and disease. hence, the problems of diseases including infectious ones affect all and sundry irrespective of current "sick status". pandemic influenza is one such incident that afflicts all sectors of the society. it also raises questions and issues related to utility and equity, ensuring the protection of vulnerable individuals and groups in society, the need to exercise public health powers with respect for human rights as well as the just allocation of human and material resources. attending to these issues, however, juggles many kinds of personal, social, political, and professional interests against one another; thus, reflecting the traditional public health dilemma of fine-tuning individual against collective good. since the restrictive approach of individualism-driven moral lenses is unsuitable for people-centered quandaries, it seems pertinent to employ a people-centric moral lens to engage them. in this vein, the ethical prism of communitarianism and ethics of care seem apt. by examining and contrasting the core fabric of the communitarian and care ethics frameworks vis-à-vis the attendant dilemmas of pandemic influenza; this chapter attempts to tease out a broader ethical path towards engaging the challenges of pandemic influenza. to properly set the conceptual foreground essential to articulating the ethical features of pandemic influenza, however, it is important to elaborate the associated biological, social, and global dynamics. these parameters, as macphail recently argues, are exigent in the explication and engagement of pandemic or infectious disease outbreaks. there have been some speculations as to the origins of the influenza virus. it has been hypothesized that the virus originated from wild waterfowls and has only slowly evolved through multiple animal species including humans. but what is known about the disease caused by the virus-influenza-is that it is a febrile illness of the upper and lower respiratory tract, characterized by a sudden onset of fever, cough, myalgia, and malaise. pneumonia is a principal serious complication and local symptoms include sniffles, nasal discharge, dry cough, and sore throat. pandemic influenza outbreaks describe the rapid spread of influenza infection. whereas there is some conceptual controversy about the description and definition of pandemics, they generally refer to the dissemination of new infective diseases to which immunity has not been developed in a widespread manner across a significant part of the world. they could break out in nations with a large geographical size (such as china, india, and the united states) or when the number of affected nations are many. the pandemic nature of influenza is historically underscored by the - incident that killed an estimated million to million people. pandemic influenza is generally characterized by an alteration in the viral subtype (due to antigenic shift), higher mortality rates among younger groups, several waves of the particular pandemic, increased capacity of spread, and geographic variation in the impact of the outbreak. specifically, influenza pandemics occur when an influenza virus mutates or when multiple strains combine, or re-assort to produce strains to which there is no current immunity. novel outbreaks of the influenza virus occur either in large nations or across selected nations in close proximity. contemporary society experiences an increased development of new serotypes of several kinds of respiratory viruses because of the evolutionary potential afforded by the human population explosion and the great global increase in human mobility. in a manner of speaking, it seems that phds such as pandemic influenza outbreaks have evolved to become recurring features of the human experience. some insights into the biological features and processes that create pandemic outbreaks support this idea. influenza viruses belong to the orthomyxoviruses family. this comprises seven genera including influenza virus a, b, c, and d. although both the genus influenzavirus a and b affect humans and cause pandemics, influenza a has been the principal culprit in known outbreaks to the extent that four major pandemics have resulted from it ( - , , , and ) . however, genetic reassortment and exchange of influenza viruses between humans and animals generate antigenic shift, which periodically introduces new viruses to the human population. this, in addition to mutation and selection, produces antigenic drift that accounts for the year-to-year variations in influenza a subtypes. wild ducks, for instance, serve as the primary host for various influenza type a viruses that occasionally spread to other host species and cause outbreaks in such animals as fowl, swine, and horses. such outbreaks often lead to new human pandemics due to novel viruses infecting immunologically naïve people. a critical aspect of the emergence of novel virus strains is genetic variation and combination that occur at the hemagglutinin (ha) antigens (of which there are ) and neuraminidase (na) enzymes (of which there are nine) between and amongst human and animal influenza viruses. the subtypes of the ha and na surface proteins forms the basis for the classification of outbreaks. for example, the through virus was h n , the through virus was h n , the through outbreak was caused by h n , the virus was h n , and the outbreak was caused by h n ; while the most recent virus seen in eastern china in was h n . all of these traditional and new influenza viruses cause pandemics of differing proportions but more are projected to occur. this projection is well supported by the scientific community. however, it is not known when any will occur or whether it will be caused by the h n avian-derived influenza virus, newer subtypes like h n , or completely novel subtypes. virologists like webster and govorkova argue that given the number of cases of h n influenza that have occurred in humans (more than ) with a mortality or death rate of more than %, it would be prudent to develop robust plans for dealing with such pandemic influenza and its (expected) new variations. such plans, however, necessarily demand attention to the associated ethical dynamics. regardless of the specific subtype of human or animal-derived influenza outbreaks, the public health challenges and the moral quandaries are essentially the same. a critical biological feature of influenza lies in its mode and pattern of transmission. this revolves around its capacity to evolve and become airborne-transmissible between and amongst human beings. the influenza virus transmits from person to person primarily in droplets released by sneezing and coughing. some of the inhaled virus lands in the lower respiratory tract, the primary site of disease marion russier et al., "molecular requirements for a pandemic influenza virus: an acid-stable hemagglutinin protein," proceedings of the national academy of sciences , no. ( ) . pp. pp. - anna v cauldwell et al., "viral determinants of influenza a virus host range," journal of general virology , no. ( ). pp. - . couch. p.; shah. p. . cauldwell et al. p. . miller et al. pp. - shah. p. . rebekah h borse et al., "effects of vaccine program against pandemic influenza a (h n ) virus, united states, - ," emerging infectious diseases , no. ( . pp. - . cauldwell et al. p. . macphail. p. . robert g webster and elena a govorkova, "h n influenza-continuing evolution and spread," new england journal of medicine , no. ( ) . pp. - . russier et al. pp. - being the tracheobronchial tree, and sometimes the nasopharynx. largely because breathing is an essential biological need of human beings and partly because human-human associations are an inevitable part of reality, this biological feature of influenza viruses makes everyone vulnerable and susceptible to infection. specifically, crowds of people facilitate viral transmission by enabling sharp upticks in the rate of transmission. the virus also circulates for longer periods in infected persons. the biological features of influenza and its mode of transmission elicit some observations. one, pandemic influenza is not a single disease for which a single and specific therapeutic intervention that will be effective all the time can be developed. in other words, while there is a general approach to engaging this public health disaster, specific interventions will usually vary by each outbreak. this gives an existential and evolutionary advantage to the influenza virus over human communities. it also engenders a disaster dynamic in the sense that every outbreak becomes "sudden" and potentially associated with large human casualties. secondly, it shows the common vulnerability to which the local and global human community are subject vis-à-vis the ease of spread of the viral infection. thirdly, the biological features of pandemic influenza demonstrate how a collective response (human material, scientific etc.) is key to engaging its social and other attendant consequences. the importance of this last remark will become clearer against the backdrop of the social and global features of pandemic influenza outbreaks, a. theme addressed in the next section of this chapter. an influenza pandemic has the potential to cause more deaths and illnesses than any other public health threat. pandemic influenza a h n were reported. also, the h n outbreak recorded a death rate of %, and the recent h n outbreak caused human infections and deaths. in the united states, the estimated potential threat of pandemic influenza is . million deaths, million sick people, and nearly million hospitalizations, with almost . million requiring intensive-care units. global estimates are higher. for instance, the "spanish flu" caused an estimated - million global deaths. it has been projected that a recurrence of the influenza strain would probably result in the death of - million individuals. these data show that substantial numbers of deaths are an inevitable consequence and feature of pandemic influenza. however, death itself often brings about certain social consequence including the death of some of the most gifted members of the society. sir william osler, one of the pioneers of scientific medicine, died of complications arising from influenza in . influenza was cited by the german war general, erich von ludendorff, as a significant reason for why the initial gains of their last offensive faltered and ultimately failed during world war . from a biological perspective, influenza exploits naïve immune systems which tend to over-respond to the influenza virus. as such, young and promising adults constitute a large part of vulnerable victims. in this regard, potential contributions to societies are nipped in the bud, young widows and widowers emerge as well as a lot of orphans. for instance, , children were orphaned due to the outbreak in new york city. influenza also spread within households soon before or after the onset of symptoms in primary infected patients. another associated social feature of pandemic influenza is the closure of schools with an attendant truncation of learning and educational opportunities, depending on the length of the outbreak. while some of these social features are local and exert localized effects, human beings as social animals with the aid of the increased means of locomotion transmit some of the local features into a global experience. the pandemic of influenza which occurred during a time of much less globalization spread to the united states within - months of its detection in china while the pandemic spread to the u.s. from hong kong within - months. it is estimated that the burden of the next influenza pandemic will be overwhelmingly focused in the developing world. however, the epidemiological notion well-known to public health experts that infectious diseases can predicate outbreaks in neighboring places and nations implies that even so-called developed societies cannot be spared as long as the current interpenetration of people across the globe remains. the influenza outbreak, for instance, spread to countries and caused a total of , cases of infection. in short, in a globalized world, infectious diseases travel in nodes of human, material, and animal networks. data from sporadic studies suggest that influenza may be fairly prevalent in africa, albeit sub-clinically. it may, therefore, have a considerable impact on morbidity and mortality on the continent should a combination of factors create a virus that is viable enough to cause a pandemic. this will have far-reaching consequences for the continent due to the material and human resource constraints, lack of preparedness plans as well as the very limited bio-therapeutic capacities that are currently available to produce vaccines. it may likewise create the dispersal of a virus novel to other continents that have experienced typical outbreaks. geographical location plays a major role in public health, and disasters including health disasters are unique in that each affected region of the world has different social, economic, and health backgrounds. as such, while there is a global spread, the nature of each local context and how it responds shapes pandemic influenza in some key ways. first, the nature of the "disseminating" nation influences how infection spreads elsewhere. for example, china's slow reaction to the sars outbreak as well as its limiting of access to patients and other relevant information hhs, "hhs pandemic influenza plan." p. b . , no. ( ) . p. eric k noji, "public health issues in disasters," critical care medicine , no. ( ) . p. s . seemed to have deepened the global intensity of that crisis. in other words, how a local public health disaster is handled shapes the local severity and how it spreads elsewhere. on the other hand, well-handled local health crises positively influence the possible impacts on contiguous nations. in this vein, radest notes that canada's rapid and coordinated response to the sars outbreak significantly limited its spread and impact in the united states. the above examples echo the interconnectivity of the modern world and show how a course of action in one place, however passive, may significantly influence the course of events in another for good or bad. it supports the idea that contemporary health in the twenty-first century is now inevitably and inherently global with respect to infectious diseases. at the heart of these remarks, however, is the possibility of utilizing different networks of human interconnectivity to actively foster the global good. in other words, learning about how people connect and relate at different levels (individually, communally, institutionally et cetera) and learning about the chief actors and players in such a relationship nexus may provide a powerful tool for driving global public health agenda. yet, integral to such a process is how responses to pandemic influenza are framed and implemented locally as well as their attendant limitations. this theme is addressed in the next section. the human instinct for self-preservation has, at the social plane, always resulted in some institutional responses to diseases, whether rudimentary, barely adequate, or sophisticated. in the context of phds, responses are shaped by the nature of the specific disaster, where it is taking place, and what human, material, pecuniary and technological resources are available to deal with the given emergency situation. for instance, the united states prioritizes building a system that ensures stable and economically viable vaccines to engage influenza outbreaks. countries that lack the same kind of resource will clearly prioritize other approaches. however, the general approaches to pandemic influenza are therapeutic and non-therapeutic in nature. this section briefly examines them. pandemic influenza outbreaks, like most diseases, have elicited some biopharmaceutical responses geared towards mitigating its disastrous effects. due to the changing biological and social dynamics associated with the outbreak, social as well as scientific responses are always evolving to keep up. nevertheless, the therapeutic measures fashioned to combat pandemic influenza fall into two groups. these are preventive measures involving the use of anti-viral drugs as well as vaccination. in the past, drugs like rimantadine and amantadine were used as prophylaxis against influenza a. but drug resistance has increasingly been observed to these m -ion channel-blocking agents. today, drugs of choice are mainly tamiflu (oseltamivir) and relenza (zanamivir). black et al. noted that early anti-viral intervention during the pandemic helped reduce the doubling time in the early stages of the outbreak. the linkage between antiviral use and reduction in clinical severity and influenza infectiousness is generally supported in the extant literature. hence, treatment of clinical cases with anti-viral agents constitutes the first-line of engagement for pandemic influenza and these drugs are employed to control or contain pandemic outbreaks long enough for vaccines to be made. yet, drugs like oseltamivir and zanamivir, usually neuraminidase inhibitors, can only help reduce transmission if given within a day of the onset of symptoms. on the contrary, delay in symptoms diagnosis, as well as intervention, favors infection dissemination. nevertheless, antiviral agents for influenza offer some protection to families and households once infection has been detected. in clinical trials, antiviral treatments have been shown to be efficacious in preventing infection, hence, slowing down transmission as well as limiting the severity of the disease. but the effectiveness of neuraminidase such as oral oseltamivir and inhaled zanamivir at reducing mortality is uncertain. in addition, there is some evidence of side-effects. for instance, in adults as in children, oseltamivir increases the risk of nausea and vomiting. also, treatment trials with oseltamivir or zanamivir do not settle the question of whether the complications of influenza (such as pneumonia) are reduced. resistance to these anti-viral drugs has also been reported, even in people who have never been previously treated with them. ultimately, the success of antiviral prophylaxis critically depends on the identification of index cases in households, pre-schools, schools, and other institutional settings. this clearly highlights the importance of personal, social, and institutional cooperation in relation to dealing with the associated challenges. on the other hand, vaccination as one of the most effective and cost-saving strategies for ameliorating infectious diseases offers a protective approach to limiting and/or curtailing the social and economic consequences of pandemic influenza. two types of vaccines are generally used. trivalent inactivated vaccine and live attenuated influenza virus vaccine, both of which contain the predicted antigenic variants of influenza a(h n ), a(h n ), and b viruses. borse et al. estimated that vaccination program against influenza prevented , - , , clinical cases, - , hospitalizations, and - deaths. they also reported that the national health effects of vaccination were greatly influenced by the timing of vaccine administration and the effectiveness of the vaccine. similarly, ferguson et al. estimated that during a global outbreak, vaccination at the rate of % of the population per day would need to begin within months of the initial outbreak. but this is not feasible under current vaccine technologies. this pragmatic challenge would, however, create a biological and social climate in which infection may flourish in a logarithmic manner. the recurring antigenic variation in influenza viruses which leads to the frequent emergence of new infectious strains increases the likelihood of continuous outbreaks. this and the capacity of the influenza virus to acquire amino acid changes in its viral proteins implies that each outbreak will demand novel vaccines. this often delays the possible response time, again creating a window where infection can readily spread, locally and globally. for instance, it will take at least months from identification of a candidate vaccine strain until production of the very first vaccine during an outbreak. this biological fact makes it difficult to stockpile influenza vaccines ahead of outbreaks and, by consequence, limits the preparedness efforts geared towards confronting the public health challenges and moral quandaries. it is important to note that vaccines have some limitations. for instance, they are not entirely safe public health interventions, especially when specifics are examined. this fact has increasingly come to light in relation to vaccines against pandemic influenza. besides sore arm and redness at the injection site as well as red eyes which have been reported in earlier vaccine trials, there has been some association between increased incidence of narcolepsy in children and the use of the aso -adjuvanted vaccine for pandemic h n influenza in scandinavian countries. in addition, anecdotal reports of fetal deaths occurring shortly after vaccination emerged in and raised public health concerns about vaccine safety. another shortcoming associated with vaccination generally is vaccine failure, which often creates a false sense of protection in recipients while allowing the continued spread of infection. in relation to pandemic influenza specifically, vaccine failure was recently reported by manjusa et al. in people of years and above as well as those who have been vaccinated against seasonal influenza. this is quite troubling partly because vaccine failure vis-à-vis pandemic influenza vaccines has been little studied, and partly because there are countries like the united states where seasonal flu vaccine shots are almost the norm. another dimension to vaccine failure relates to the variation of influenza virus clades. nelson et al. recently reported that nigeria, côte d'ivoire, and cameroon exhibit more variable patterns of influenza virus seasonality, hence, there is a possibility of variants evolving locally within west africa. this, they further argue, undermines the assumption that a vaccine matched to globally dominant lineages will necessarily protect against these local lineages. this notion further raises the question of whether the immune system of populations living in tropical african hhs, "hhs pandemic influenza plan." p. b . environments would react similarly to a vaccine developed mainly for populations restricted to certain geographical areas of the world. on this note, in the possible event that someone originally from any of these nations were present in a pandemic influenza scenario outside african shore, the likelihood of their benefiting from vaccination seems slim. hence, a significant offshoot of vaccine failure in relation to pandemic influenza (especially if newer studies show more negative results) will be the reluctance of people to receive vaccines for seasonal flu and those developed for pandemic influenza outbreaks. these have unsettling public health and moral consequences. one way of engaging the limits of influenza vaccines involve creating a vaccine type that is capable of eliciting cross-protective peptides/epitopes that would be effective against different variants. but this is very difficult. besides the scientific technicalities, producing vaccines for pandemic influenza is not a cheap venture. for example, meltzer, cox, and fukuda estimated in that it would cost the united states about $ . billion to contain pandemic influenza. whereas the economic burden of influenza in lower-and middle-income countries involves direct costs to the health service and households and indirect costs due to a loss in human productivity, these countries also have limited financial capacities to pursue pandemic influenza vaccination as a public health tool. the impacts of the ensuing disease burden from such a constraint will not be locally confined, as it will ultimately seep into the trans-national and global terrains. in summary, the major and, perhaps, insurmountable constraint to vaccination as a tool for engaging pandemic influenza lies in the logistic challenge of producing a pandemic vaccine from scratch, conducting pre-clinical testing as well as generating billions of doses within a very short time for global distribution, which may, however, not work across all nations. but considering the limitations associated with antiviral drugs as well as vaccines in relation to combating pandemic influenza, some form of non-therapeutic approach is necessary, at least as some adjunct to mitigate the overall impact of pandemic influenza on the local and global human community. the next section addresses this theme. yazdanbakhsh and kremsner. p. e . the non-pharmaceutical and non-therapeutic approaches to pandemic influenza revolve around measures such as case isolation, school or workplace closure, restrictions on travel, quarantine as well as contact tracing. for instance, school closure is a non-pharmaceutical intervention often suggested for mitigating influenza pandemics. the logic behind this lies in the notion that children are important vectors of transmission, more infectious, and susceptible to most influenza strains than adults. it is also tied to the idea that high a contact rate in schools fosters transmission of infection. this approach, according to cauchemez and colleagues, may bring about an estimated % reduction in peak attack rates. however, this reduction will be hindered if children are not adequately isolated or if the policy is not well implemented. whereas school closure may only bring about a small reduction in cumulative attack rates, it can foster a substantial reduction in peak attack rates. closure of schools may, however, increase anxiety and create a crisis, as was observed in france during the outbreak. closure of workplaces is another non-pharmaceutical intervention for pandemic influenza. it may be warranted by the degree of the outbreak in which businesses shut down at their own discretion, and for their own safety, as was seen during the - outbreak. however, it may also be warranted by government policy. either way, business closure incurs huge economic costs, pecuniary, and other consequences for the different people tied to and/or dependent on the affected businesses or their services and goods. different forms of quarantine measures are also used to mitigate the spread of infection during an influenza pandemic. for instance, isolation and quarantine of infected patients allow some containment of infection which consequently slows down viral transmission. ultimately, quarantine contributes towards reducing the overall costs and impact of an outbreak. some medical experts see household quarantine as the most effective social distance measure, provided the level of compliance is good. yet, quarantine-at least on a general note-does not always work. for example, maritime quarantine was one of the measures employed in west africa to engage the influenza outbreak as well as interning the ill. however, historians like heaton and falola note that these approaches yielded meager success in relation to quelling the spread and virulence of the pandemic. measures such as cancellation of non-essential public gatherings and restrictions on long-distance travel might help to decrease influenza transmission rates as well as overall morbidity, their effectiveness has not been quantified. the nature of pandemic influenza, the therapeutic and non-therapeutic approaches, and the associated limitations generate some moral concerns. the next section discusses this. ethical issues arise during outbreaks of pandemic influenza. some of these are directly tied to the nature of the virus, some in relation to human responses, some to the social responses, and others to how different human beings respond differently to the several challenges elicited by the pandemic. bioethicists have underscored the critical need to reflect on the ethical issues raised by the specter of pandemic influenza outbreaks. however, what may and what may not be feasible to do will never be clear enough if these ethical quandaries are not clearly explicated. hence, this section seeks to clarify the moral quandaries elicited by pandemic influenza and show the core connecting strands that resonate amongst them. generally, contexts of uncertainty are tied to the evolving nature of knowledge. tannert et al. opine that uncertainty occurs because the more the human community gains insights into the mysteries of nature, the more they realize the limits of their knowledge about how things are. these limitations, they note, make it impossible to foresee all the associated future effects and implications of situations and decisions with certitude. in relation to medicine, jean daly notes that the art of medicine seeks to abolish uncertainty. regardless of the good intentions and telos of medicine, the stark reality is that this task has hardly been achieved. contexts. james marcum contends that uncertainty is largely a part of medicine because of the variability of the underlying biology. uncertainty is not new in the realm of science. however, in the context of public health disasters uncertainty has a strong pragmatic dimension which can influence courses of actions and decisions in multiple unfavorable ways. for example, it occurs during pandemic influenza outbreaks and generates many concerns. in this vein, borse et al. note that the public health community cannot accurately predict the arrival of a pandemic. indeed, a great deal of uncertainty occurs in relation to estimating the potential impact of a pandemic such as influenza. this scenario stifles preparedness efforts, especially in resource-constrained countries where there are often competing social needs to be met with limited budgets. however, the two main uncertainty issues embedded in pandemic influenza involve the nature of the virus and the types of responses available to engage outbreaks. on the one hand, the influenza virus undergoes constant variation in its antigens, creating new infectious strains. the virus also acquires amino acid changes in its proteins. these scenarios increase the likelihood of pandemic outbreaks. however, the question of when, where, and of what magnitude the outbreak will be is never clear-cut. worst-case scenario analysis based on the - pandemic provides no insight into the probability of an influenza pandemic in the next , , or years and how serious such an outbreak might be. this scientific uncertainty or paucity of precise knowledge ignites some social uncertainty and may prompt moral inertia in relation to the level of preparedness and the ability to mitigate the various possible ramifications of an outbreak, when it does occur. this backdrop of uncertainty creates at least three possibilities: over-preparedness, ample preparedness, and under-preparedness. assuming the level of risks remains constant, over-preparing for a pandemic will undoubtedly involve the committing and expenditure of more human and material resources to an outbreak. this will create a sense of waste (to decision and policy makers) after the incident and may affect the resources that will be committed to future outbreaks. the right amount of preparation will help curtail an outbreak while under-preparedness will barely help curtail an outbreak. however, if the level of risk increases, over-preparing may help curtail a pandemic whereas what was hitherto ample preparedness as well as what was hitherto not enough will enable the full range of the effects of a pandemic outbreak to be felt. " ibid. , no. ( ) . p. . kuby. p. . murray et al. pp. - . in other words, the changing nature of the virus demands a constant readjustment of the level of preparedness without a reliable frame of reference with the attendant possibility of some inevitable social harm. not surprisingly, scholars like peter doshi argue that there is a need for evidence-based ways to address hypothetical scenarios of non-zero probability such as the notion that novel influenza pathogens acquire increased virulence during successive "waves" of infection. the scientific uncertainty associated with health disasters such as pandemic influenza may, however, tempt government officials to attempt some form of a cover-up, hence, raising trust issues. for instance, during the cholera outbreak in naples, italian officials paid newspapers and reporters not to report the outbreak. chinese officials tried to keep the sars outbreak a secret. saudi officials, likewise, tried to silence the virologist who discovered the coronavirus in and ultimately forced him to resign from his position. incidents like these have the tendency to dissuade social cooperation during public health emergencies like influenza and have the potential to weaken the overall success of public health interventions. on the other hand, there is a lot of uncertainty surrounding the therapeutic and non-therapeutic approaches adopted vis-à-vis pandemic influenza. it is uncertain, for example, if neuraminidase antiviral drugs really cut down mortality when implemented as the first line of defense. this may create some sense of hesitation in relation to using them. secondly, it is uncertain who and who will not develop some of the associated side-effects. these factors, at a pragmatic level and for less rich nations, may dis-incentivize prioritization of funds for antiviral drugs. uncertainty likewise plays out in the context of influenza vaccines. for instance, only a small amount of any vaccine can be stockpiled because the scientific and public health community can hardly be sure of the efficacy of any given vaccine prior to an outbreak. this is due to possible vaccine failure which will make a new outbreak not amenable to the biological effects of hitherto effective vaccines. hence, vaccines are generally not produced until the new virus strain causing a pandemic is isolated. also, there is uncertainty over who will be at highest risk of infection and complications. this creates a dilemma of some sorts with the potential that a class of the people who need vaccines may not get enough, while another class of people who will benefit less from vaccination gets too much. another kind of uncertainty is linked with possible side-effects of vaccines. while some incidence of narcolepsy was reported in children after the use of aso -adjuvanted h n influenza vaccine in scandinavian countries, and there have been anecdotal reports of fetal deaths doshi. p. . shah. pp. - . hhs, "hhs pandemic influenza plan." p. s - . kotalik. p. . emanuel and wertheimer. p. . dauvilliers et al. pp. - occurring shortly after the vaccination ; it is not clear if these safety issues are one-off events or may recur for other pandemic vaccines. responding to influenza vaccine safety signals during a pandemic constitutes a scientific and public health policy issue since decision-makers must balance the immediate consequences of disease against uncertain risks. one of the consequences of the therapeutic uncertainties associated with pandemic influenza is the validity of administering potentially ineffective antiviral drugs with side-effects or vaccines that may cause harm to people. another is the validity of withholding such drugs and vaccines because it may not be useful for some class of people, or because some people may experience certain degrees of side-effects. these issues raise concerns about human rights and whether or not they may be violated through these courses of actions, or by any other course of action associated with handling a pandemic influenza outbreak. the universal declaration of human rights and the international covenant on economic, social and cultural rights documents enunciate the rights of "everyone to the enjoyment of the highest attainable standard of physical and mental health". hence, it is perhaps more than ever taken for granted that there are rights-related obligations that society, as well as healthcare providers, owe patients as well as those that may potentially fall sick. since everybody is theoretically a potential victim of ill-health depending on time, placek and social or physiological circumstances, individuals can appeal to a rights-based rhetoric to garner positive action from government and healthcare professionals in relation their health. the morality of such a claim stems partly from governments' moral obligation to their citizens and partly from the fiduciary obligations that health professionals have towards fostering the health of patients (and potential patients) in a fashion that preserves their rights as human beings. many moral concerns related to human rights come to the fore in the context of pandemic influenza outbreaks. the first is related to the limited number of vaccines that can be available for each outbreak (due to reasons outlined in the preceding section) and the best sharing formula to use. whatever adopted formula in a given place or situation, some people who may benefit could be excluded. for instance, pandemic influenza often generates a high number of sick people over a large geographic area who will need care at the same time. while this "need" begins at the local plane, it may evolve to be regional and/or global depending on the extent and severity of an outbreak. hence, the human and material resources of healthcare will be rapidly depleted and overwhelmed. since the needs of everyone cannot be met under such a scenario, there is usually some need to ration available resources. in fact, vaccines are hardly enough during pandemics, and rationing is generally considered as the ethical option. yet, the contemporary interconnection between health, the right to health and human rights implies that withholding vaccines from some people who might be potential victims of a pandemic outbreak may be a human rights violation. on the other hand, administering antiviral drugs to non-vaccinated at-risk people helps reduce the severity of illness. during disaster scenarios, the goal remains saving lives but a pandemic scenario in which - % of the population can fall sick within a very short time often demands some type of prioritization of resources. this is partly because keeping some sets of people alive, especially health workers will ultimately help society keep more people alive during a public health disaster. for instance, the traditional view is that prioritizing the vaccination of front-line healthcare workers can help reduce staff absenteeism as well as help prevent them from becoming vectors of viral infection. this is often justified by the logic that a phd situation such as pandemic influenza often makes health professionals work outside their normal scope of practice, put in extra hours, cover for ill workers, accept great risks as well as incur other situational unexpected responsibilities and supererogatory duties. although adults aged years or older, pregnant women, and people of any age with underlying medical conditions are at high risk of pandemic influenza and its associated complications, the notion that death is more tragic in children and young adults as opposed to elderly persons, perhaps, because younger persons have not had the chance to live and develop through all stages of life and accomplish their dreams has made some ethicists argue for the prioritization of vaccines to younger people. yet, if persons are inherently born with human rights and do not have to earn rights, such an idea tends to revamp the rights to health of some class of people at the expense of others. indeed, notions such as this echo the idea that mainstream bioethical issues tend to be far-flung from the values of ordinary people and often irrelevant to the decisions they experience in their encounter with healthcare. in other words, an empirical approach which takes into consideration what people would want when faced with this thorny dilemma rather than an armchair speculation ought to influence the criteria for rationing vaccines. one of the non-therapeutic responses to pandemic influenza is the isolation and quarantine of infected patients. whereas a visibly infected and sick person may have just a little objection to quarantine (after all, such a state mirrors the ambulatory limitations that most disease states naturally impose on people), it is often problematic for other categories of people. in this vein, isolation and quarantine raise concerns about the acceptability of confining people and preventing them from engaging in some of the social activities they otherwise would have loved. whereas restriction of movement is ethically problematic, it is equally problematic to allow person a who may be infectious to roam free, thereby potentially infecting other persons who may also (without the imposition of some restriction) further spread infection. it is clear from the foregoing that pandemic influenza challenges and raises some moral concerns regarding the rights of people, preempting the need to balance them against what is the optimal good of the society. but embedded in these reservations is the demand for autonomous living, broadly conceived. whereas this has been associated with western contexts, concerns about rights violations in relation to quarantine measures are not confined to the west. sambala and manderson recently commented about how ghanaians and malawians perceive public health interventions including quarantine as being intrusive. but this perception seems to run contrary to the cultural norm of most african people. in relation to this strand of thought, shah notes that during epidemics, the traditional attitude of the acholi people of uganda involves working together to isolate the sick, mark homes of the sick with long elephant grass, warn outsiders not to visit affected villages, and refraining from potentially infection-transmitting practices including sexual intercourse. this suggests at least two things. one, in traditional african societies there may be some fairly general consensus about the need to adopt mutual and social cooperation for the overall benefits of the society in engaging collective threats. secondly, it shows how the global village has increasingly penetrated and fragmented societies that were once non-individualized in orientation. but it seems that societies have been affected differently by the globalizing current of individualistic logic. for instance, macphail whereas europeans and americans generally view quarantine during influenza as almost worthless, asians such as hong kongers, expect it as the norm during health disasters, and demand it. this probably shows how strong an influence the communal-oriented confucian idea still exerts in that country. in the context of pandemic influenza outbreaks, over-emphasizing individualism and the attendant call for autonomy (even when such does not cohere with social interests) overlooks communal values and the relational nature of social interactions. it likewise ignores the complex nature of pandemic influenza and how it plays out in an equally complex web of this global age and how people more or less are susceptible to the harms of public health disasters regardless of their proximity. it has also contributed, as lachman argues, to a reduction in the fear of infectious diseases by increasing the emphasis on patients' rights, giving rise to a dangerous complacency that may do great damage to the goals of public health. one of the ways to address the attendant dangers inherent in this almost pervasive trend is recognizing the vulnerabilities even to far-flung harm that is fast becoming an integral aspect of contemporary life. vulnerability-in different forms and facets-plays out in pandemic influenza, as in other public health disasters. traditionally, belonging to the human community or occupying specific facets of life constitutes sources of vulnerability. but the state of being susceptible to harm by the actions and activities of other people or by parts of nature such as viral organisms is also a potential source. in addition, the state of vulnerability may ensue from a range of social, economic, and political conditions. in the context of pandemic influenza, the naturalistic, socioeconomic, epistemic, political, and biological dimensions of vulnerability arise. on the one hand, humans located in pandemic-prone cities or countries and other human beings linked to the global community by technological means of transportation (such as air travel) or non-technological ones (such as migrating birds) are generally vulnerable to influenza outbreaks. the likelihood of a novel strain of influenza outbreak occurring in a country such as china (for instance, jiangcun in guangzhou) where large numbers of people, birds, and swine mingle freely in certain markets is very high ; hence, making the local population and consequently the people of such a nation more vulnerable. macphail, the viral network: a pathography of the h n influenza pandemic. pp. - . bennett and carney. p. . peter j lachmann, "public health and bioethics," the journal of medicine and philosophy , no. ( ) . p. . henk ten have, "vulnerability as the antidote to neoliberalism in bioethics," revista redbioética/unesco , no. ( ). p. . on the other hand, the strength of health systems reflected by availability of experts, economic and technical resources will vary the extent of pandemic-related vulnerability which different societies will experience. in addition, it is widely believed within the scientific community that influenza pandemics can hardly be halted, but they can be delayed. therefore, the "ignorance gap" that occurs during pandemic influenza outbreaks creates a context in which some of the preparatory strategies will inevitably fail (due to no fault of anyone), thereby leaving some people less protected. in relation to the socioeconomic dynamics, it is estimated that most influenza pandemic-associated deaths occur in poor countries or in societies with scarce health resources which are already stretched by extant health priorities and challenges. farmer and campos underscore the need for bioethics to engage the growing problem posed by the gap between rich and poor nations, and how such a course of action reflects social justice. politically, communist nations such as china present unique dimensions to the vulnerabilities of pandemic flu as they may control critical information traffic and access to patients, thereby deepening the crisis situation, or misrepresenting it, and thereby subjecting the rest of the connected world to avoidable risks. the biological make-up of human beings both make them vulnerable to becoming infected with influenza virus as well as make them good vectors of dissemination. for instance, the virus has a surface molecule that enables it to attach firmly to cells in the mucous membranes of the respiratory tract, preventing it from being swept out by the ciliated epithelial cells. but breathing is a normal aspect of human existence, and the oxygenation of the human blood and other oxygendependent biochemical processes of the human body rely on it. yet, the combination of these factors facilitates the ready transfer and exchange of the influenza viruses amongst people, especially when they are in close proximity. the foregoing shows how susceptibility and vulnerability to infection during pandemic influenza reflect a combination of factors. how these combine in specific localities and regions will, therefore, determine the extent of an outbreak. it is also clear that some amount of control can be exerted on minimizing some of these factors. for instance, the use of face mask (to limit infection acquisition and spread), transparency (to combat political bottlenecks), and monetary aid (to help poor nations) will exert some preventive effects on infection transmission, hence, limiting the overall burdens and severity of an outbreak. since everyone may not receive the same level of healthcare for various reasons during a public health disaster (depending on time, place, and category of persons such as adults, the aged, or children), questions about justice and what is just in the context of a pandemic outbreak arise. pandemic outbreaks exacerbate extant inequalities to the extent that certain groups of people face disproportionate risks and impacts of disease. this obviously seems unfair, especially if pre-pandemic actions that would have ameliorated the situation were not done. for instance, school closure in certain districts may interrupt educational opportunities or growth of some children, and business closures will lead to financial losses. since such restrictions may not apply to every region of the nation, these measures may seem unfair to those affected, knowing that other children continue to have access to education, and other people continue to run their businesses. if this characterizes the feelings of some of the people affected by these restrictions, then it is reasonable that some form of compensation may be required to foster optimal compliance to the public health measures that are to implemented. indeed, bioethicists like michael selgelid and søren holm make explicit arguments for some form of compensation to people who suffer financial and other losses due to compliance with public health directives issued during influenza outbreaks. although compensation may not be a problem in more affluent nations where other educational stimulus and business tax breaks may help alleviate any temporary pandemic-associated losses, poorer countries will find it hard to compensate people for any such losses. rationing also raises issues about justice in terms of how vaccines (if available) will be shared during an influenza pandemic. given the limited amount of supply available globally, and locally in a developed economy like the us, distributing the limited supply will require determining priority groups. for people not to feel a sense of being left out during local vaccine administration, it is better to have debated and developed a preparedness plan with the consensus of the local populace. resolving vaccine distribution on a global scale will, however, involve very complex sets of factors. for instance, will countries who supply most of the technical and financial resources to develop such an influenza vaccine demand that the needs of her people be prioritized as opposed to the needs of nations that have contributed little or not at all? even if such a question were not explicitly raised, will it be fair to distribute vaccines equally if every country or affected region has not made significantly even contributions? these are unsettling questions that are bereft of simple answers. some ideas stand out when all the ethical issues generated by pandemic influenza are closely examined. four of these ideas demand attention. the first is the need to help people. secondly, the nexus of relationship that exists between people henk ten have, vulnerability: challenging bioethics (routledge, ). pp. - . michael j selgelid, "promoting justice, trust, compliance, and health: the case for compensation," the american journal of bioethics , no. ( emanuel and wertheimer. p. . and the influenza virus and the changing nature of what is known as well as what can be done to help people under such constraints will limit the help some people may ultimately get during an outbreak. thirdly, the threat of an outbreak presents different risks which vary by context, time, and place. lastly, regardless of the different situational dynamics that pandemic influenza presents locally, regionally, and globally; its threat will affect everyone to varying degrees. since nations theoretically care about their people, it is only reasonable that a people-centered approach offers a useful way to engage the moral quandaries elicited by pandemic influenza outbreaks. the subject matter of diseases is human populations. in fact, the preoccupation of medicine remains the amelioration of the distress of people technically referred to as patients. if a people-centric approach constitutes a viable way of engaging the ethical issues embedded in pandemic influenza scenarios, one way to glean a sufficiently nuanced angle on such an approach will involve turning to ethical lenses that are, in principle, people-oriented. two principal examples of such ethical prisms are communitarianism and ethics of care. this section briefly explains each of these moral lenses, and how each may help engage the ethical issues generated by pandemic influenza. the communitarian moral lens adopts a people or community-centric perspective to moral issues. applied to public health, it offers a population-centered approach which best reflects the philosophy of public health in terms of its commitment to doing the most for the greatest number of people in a society or within a social context. bioethicists like stephen holland regard the communitarian lens as useful since it aims at realizing collective interests. this same idea offers a strong justificatory argument for adopting it in relation to public health interventions. communitarianism pays attention to the social sphere, institutions, and interrelationships in relation to moral judgments that will inform public health policy and practice. its ethos provides an alternative to the dominant atomistic lens of individualism which operates via the logic of self-protection and the unbridled macphail, the viral network: a pathography of the h n influenza pandemic. p. . stephen holland, public health ethics (polity press, ) . pp. - . pursuance of self-interests. it holds that the social nature of life and institutional and social relationships should inform moral thinking, and by implication, the process of determining appropriate courses of actions should lie within the social space. to be sure, the communitarian notion appeals to the historical traditions of communities or people who share customs, ideals, and values ; and thus prioritizes common threads of thought and practices within specific communities as a strong moral basis for justifying decisions that pit different individual and social interests against one another. there is an important phenomenological aspect of communitarianism. for people raised within the traditional family structure-father, mother, children, and relatives-the family unit constitutes a micro-community which generally socializes the child into a community-oriented way of reasoning. while the strength of such an orientation is expressed in different measures by different individuals, it also provides the cognitive platform for balancing and pursuing personal interests in a feedback loop with the collective interests of other family members. yet, the ultimate measure of what level of community-oriented reasoning an individual retains in adult life will depend on their education, social experiences, whatever meanings they draw from these, and how these parameters are brought to bear in the context of specific decisions and choices. this reality partly explains the multiple versions and interpretations of communitarianism, which tends to mar its conceptual and theoretical coherence. it also partly explains why community values are not generally shared by all. communitarians advance three different types of claims: descriptive claims which stress the social nature of people; normative claims which celebrate the value of community and solidarity, and a meta-ethical claim which emphasizes the idea that political principles should mirror "shared understandings'. two of these dynamics-the normative as well as the metaethical-are important in relation to engaging the ethical issues elicited by pandemic influenza. the significance of the meta-ethical dimension of communitarianism is its capacity to help drive and ground public health policies. this is especially so considering the reality that community and living together in today's fragmented and individualistic world is generally seen ever less as a necessity and assumes the dimensions of a choice as the default state. hence, these two facets will be examined in relation to their possible insights and pragmatic importance vis-à-vis engaging the quandaries associated with influenza outbreaks. healthcare focuses on helping sick people regain optimal health and healthy people maintain good health. pellegrino and thomasma remark that medicine seeks to foster social flourishing as well as the medical good of society. if this is true, and if the end of the communitarian moral lens is to ensure the survival of the society by promoting the interests of people over the selfish interests of individuals, then how can this approach help engage issues of uncertainty, vulnerability, human rights and justice? this can come through appropriate educational policies and approaches carried out prior to and during influenza outbreaks. it is not known when and in whom influenza therapeutic interventions such as antiviral drugs and vaccines may cause side-effects. it is also not known when an outbreak will occur or the attendant magnitude. since public health disasters are classless in terms of who will and who may not be affected, the scenario of uncertainty affects every segment of people in the local communities and nation. hence, health workers, government officials, the rich, the poor, the educated and illiterates and other possible stratification of society are potential victims. a communitarian ethos is useful in at least two ways in relation to dealing with the uncertainties associated with pandemic influenza. generally, it can-with the right pre-disaster public education-help ensure that people understand the unavoidable scientific and knowledge-related gaps in preparedness policies and specific plans put together to engage a specific outbreak. this will help avoid or minimize blame, since scapegoating during disease outbreaks causes different shades of disruption and target important actors including health workers. in fact, the better educated the public is about the challenges of stockpiling vaccines, the more cooperative they will likely be to the vaccine-supply challenges that arise during an outbreak. a communitarian ethos may also help engage the real and possible harms that may ensue due to the therapeutic uncertainties associated with pandemic influenza. these harms arise from the uncertain nature of what is knowable about a pandemic virus before it strikes as well as the biological limits of the therapeutic arsenals often produced within a very narrow time window. this is also generally tied to the reality that new health interventions including drugs and vaccines come with the possibility of some adverse events, which may be linked to the chemical/biological/physical components of the product, to genetic susceptibilities in certain individuals, or to edmund d pellegrino; david c. thomasma, "the good of patients and the good of society: striking a moral balance," in public health policy and ethics, ed. michael boylan (springer, ) . pp. - . shah. p. . environmental triggers. keeping the public aware of this fact before and during an outbreak as well as emphasizing that accepting these risks (though uncomfortable at the individual plane) will serve to ensure the society overcome a pandemic should help garner some level of support critical to ensure proper compliance. since people are born with inherent human rights and do not have to earn them, it is hard to justify trumping the rights of some for the sake of public health. this is especially so if the people whose rights may be inhibited or violated do not consent to the process. to avert this, a discursive approach involving inclusive deliberations is essential. in this vein, the communitarian lens can help foster dialogue as well as call for the need to reward people for the sacrifices they may or will bear on behalf of the community and the society. for instance, guaranteeing that some compensation will be paid for financial losses incurred through workplace closure as well as apt public education about the nature, purposes, and conditions of quarantine facilities will help convince people that such temporary rights-related inconveniences are for the benefits of the overall society. in relation to vulnerability and justice, the communitarian lens can help clarify the different kinds of social, biological, and natural vulnerabilities that face different people in different contexts. for example, it can offer a way of making the important distinction between general vulnerability that people will experience as human beings, vulnerability based on age, and occupational vulnerability seen in health professionals. based on these distinctions, it can help underscore how context-specific cooperation will help ensure the overall success of the countermeasures adopted to engage a given pandemic. critical to this, however, is the moral currency of trust. trust shapes how the public evaluates risks and benefits. it also influences the acceptance of prescribed public measures to mitigate present or perceived risks. effective risk and crisis communication depend on public trust in the government during a pandemic. as such, a higher level of trust will influence a more positive level of social compliance. van der weerd and colleagues corroborated this in their empirical study of the pandemic in the netherlands. in addition to trust, transparency in terms of how priorities will be made in terms of the allocation of vaccines as well as antiviral agents, and decisions pertaining to school and/or workplace closures is important. even in western climes, public health experts have sometimes pointed out the paucity of transparency in ethical reasoning and the scanty explicit ethical justification for pandemic-related policies. obviously, an atmosphere of trust and transparency will be conducive to discussing and addressing issues related to local justice. this is especially relevant in relation to less wealthy nations or countries with weak institutions. for instance, it will be hard to garner cooperation in hitherto abandoned communities by appealing to communitarian ethos without addressing extant disparities in the social fabric as well as the healthcare system. if human beings are located in particular communities but are willy-nilly part of a global community, how well the vulnerability and justice-related issues are locally addressed will influence the extent of their regional and global dynamics. this echoes the notion that badly managed local issues associated with pandemic influenza will pose more challenges and burdens at the regional and global levels. since every nation lacks an equal capacity to deal with the local burdens of pandemic influenza, it is necessary for wealthier nations to rally around poorer ones. indeed, the transcontinental nature of health disasters including pandemic influenza and sars underscores the urgent need to strengthen how the global community deals with emerging infectious diseases, and how novel visions of global solidarity and cooperation will be key in such an endeavor. this constitutes a preventive stance and falls well within the traditional agenda of public health. this approach is also a reasonable economic and health security choice as it will statistically cut down the possibility of global and transnational infection dissemination. while the communitarian ethos as argued above offers some insights into how to flexibly engage the moral dilemmas generated by influenza outbreaks, its application in non-community-oriented contexts potentially raises some difficulty at the institutional and individual planes. such possible difficulties, however, call for a global but locally nuanced moral framework. that theme, however, will be addressed in chap. . for now, the rest of this chapter will explore another people-centric moral lens, care ethics, in relation to resolving the quandaries of pandemic influenza. in addition to the communitarian lens, the ethics of care perspective (eoc) constitutes a people-centric method of attempting to resolve ethical issues. whereas it sometimes arrives at the same conclusions reached by traditional bioethical approaches, employing it as a complimentary approach to the moral quandaries generated by pandemic influenza should yield additional nuances and insights visà-vis resolving the associated moral concerns. care ethics emphasizes varying degrees of care within relational contexts ranging from the personal sphere to the realm of moral strangers. hence, it is an other and people-centric moral lens. it has henk ten have, global bioethics: an introduction (routledge, ). p. . peter a singer et al., "ethics and sars: lessons from toronto," british medical journal , no. ( ) . pp. - . edwards, "is there a distinctive care ethics?" p. . been applied to diverse relational contexts including everyday lives, professional practices, social and public policies, as well as international relations. for scholars like steven edwards, ethics of care uses a distinct ontological commitment to realize its outcomes as well as justify its stance. it is an attempt to re-conceptualize and renegotiate the moral landscape in order to give room for a plurality of values. some have argued that the removal of friendship with its altruistic emotional sequelae and the subversion of virtue ethics from the sphere of morality were some key factors that warranted the moral change which birthed the ethics of care framework. while eoc is also linked with gender-based morality which undergirded campaigns for equal employment opportunities between the sexes, legal rights, reforms of family life and sexual standards, and better education ; scholars like noddings have pointed out that it is broader and deeper than feminist ethics. to be sure, one of its major impetus is the call for the expression of higher capabilities. care ethics also encapsulates a spectrum of ideas. for kittay, care constitutes an "achievement term" such that caring occurs only when specific acts of care have been carried out. in this vein, intentionality would not qualify as part of the baggage of care rhetoric. this obviously has some pragmatic appeal. most people, for instance, would only appreciate care if it helps contribute towards relieving their current distress. yet, caring may also constitute a general attitude and an orientation which may provide appropriate background conditions for shaping responses to others' needs and states of distresses. also, one may care but situational constraints may limit how a caring impulse may translate into pragmatic ends. therefore, that someone simply "lacked opportunity" to show care as apostle paul writes in his epistle to the philippians does not necessarily indicate the absence of care. hence, caring cannot be reduced only to materialistic terms. one way to distinguish the general caring orientation from specific acts of care is to refer to each as "caring about" and "caring for" respectively. care ethics locates morality within the ambiance of family, friends, and colleagues, and ultimately towards the public sphere. it rejects the independent and atomistic notion of the self and champions an inter-dependent and inter-related view. this approach grants eoc a psychological gestalt to which people brought up in caring relationships, at least in the early phases of their lives, can readily identify with. it thus partly appeals to kohlberg's theory of moral development. here, the emphasis is put on the foundational roles of trust and its place in fostering a deepened sense of reciprocity within a social context of inequality. not surprisingly, some ethicists describe caring as the primary virtue which offers a general account of right versus wrong actions as well as political justice. whereas the informal social contract idea underlies inter-personal and stateindividual relationships, the care ethical lens may be applied to the personal sphere as well as social institutions due to its multiple ways of situating relationality. indeed, eoc focuses on attentiveness and sensitivity to the needs of others and offers a moral compass for teasing out delicate boundaries between obligation-based ethics and responsibility-based ethics. as such, it seeks to transcend the depersonalized realm of asking "what obligations do i have to mr. x" to the humane realm of asking "how can i help mr. x" in scenarios of moral crises. since caring embodies an activity, a set of activities or a labor of care from one person to the other, it presupposes that the capacity for receiving care will be present in the recipient(s) of care. public health disasters including pandemic influenza with their myriad of ethical and pragmatic challenges create a spectrum of needs and contextual dependencies which some people will have to meet, directly and indirectly. it thus creates different types of carer versus cared-for relationships between and amongst victims, atrisk people, health workers, and government officials. since it is a foundational nexus like these that underlie the caring ethic, it will be insightful to examine how the ethics of care moral lens may help resolve the moral dilemmas elicited during pandemic influenza outbreaks. osuji. p. . whereas tirima recently argued that ethics of care is irrelevant to addressing the moral imperatives in disaster scenarios because it only builds off on relationships and, therefore, requires some proximity between the caring moral agent and the cared-for victim, such a stance is flawed for at least three important reasons. firstly, care ethics can, through relevant public policy, positively influence how victims of disasters are cared for. secondly, contexts of duty exist between some of the players and victims of disasters which form the basis of a relationship of caring. for instance, healthcare professionals incur fiduciary duties to at-risk people, victims of a public health disaster as well as the general populace that may potentially be infected and infect others. thirdly, if the care ethical prism emphasizes how individuals may offer help "in scenarios of moral crises, then it should be relevant in health scenarios where different kinds of conflicting moral emergencies occur. the application of care ethics to specific disaster contexts such as influenza outbreaks, however, requires elaboration. specifically, this needs some explication with reference to issues of uncertainty, vulnerability, human rights and justice. whereas the dilemma of uncertainty that arises during pandemic influenza affects everyone, it will affect different sets of people differently. for instance, the biological uncertainties associated with an influenza outbreak are not known to the same extent by public health experts, health workers, the literate, and illiterate members of the society. caring about the potential practical consequences that may result from the attendant "ignorance" gap should, therefore, involve sharing as much useful information as possible between and amongst the different rungs of people. the relational context, in this regard, may be situated and realized through professional associations, institutional contexts, public announcements through media outlets and patienthealth professional interactions. kunin et al. recently reported on how primary care physicians helped pass on important pandemic-related information to out-patients during the pandemic in israel. this, they concluded, helped enhance the success of the national pre-pandemic preparedness plans. indeed, during public health disasters, the speed at which information is needed by policymakers may be faster than is usually possible through traditional mechanisms of research dissemination. this scenario makes information sharing a norm; even possibly those provided by preliminary research findings. humans instinctively show care to other humans in need. while this caring instinct has been socially modified and conditioned in some parts of the world where individualistic tendencies run rife, some communal-oriented cultures give room for a freer expression of the instinct of care. the instinct of care may, however, be counterproductive in the context of phds. for instance, during pandemic influenza, sick and dying patients remain active carriers of infection, as such, will infect susceptible friends and relations who feel obligated to show care in relation to helping them. in other words, "unbridled" caring may increase the vulnerabilities elicited during pandemic influenza. yet, the care ethics moral lens may help modify and re-direct the caring impulse in a more socially useful way during a pandemic. the other-centric nature of the eoc lens implies that people should care not only about themselves but about others, perhaps, even moral strangers. how person a will care during a public health disaster will, however, differ from how b will choose to act in a manner that reflects care, depending on their levels of knowledge, resources available to them as well as their social and spatial location. in other words, how a healthcare worker will care professionally in the hospital context and supererogatorily in the non-hospital context will differ from how a lay member of the society can show care in a pandemic situation. however, appealing to the eoc may help facilitate the selflessness needed. if someone cares that their society survives an influenza outbreak, then they should be willing to play roles that will help bring about that goal. this will facilitate compliance with therapeutic measures such as vaccines and antiviral drugs as well as non-pharmaceutical measures such as contact tracing, quarantine, and workplace closure. collective adherence to these measures will help cut down the susceptibility and vulnerability of individuals, groups of people, and the society to the impact of influenza outbreaks. by enabling the willingness of people to subject themselves to the public health restrictions required to contain pandemic influenza and accept the potential risks and side-effects associated with vaccines and antiviral agents, the eoc approach may indirectly eliminate or downplay the human rights-related quandaries engendered by pandemic influenza. noddings has argued that attentiveness and responsiveness are exigent to rights, flowing from one person to the other. if this is true, then the eoc may help individuals adjust the emphasis they place on articulating their rights contextually during an influenza pandemic for the sake of the collective good. finally, an appeal to the care ethical lens may help address the moral quandaries associated with local justice. although some versions of care ethics hold the posi- ns crowcroft, lc rosella, and bn pakes, "the ethics of sharing preliminary research findings during public health emergencies: a case study from the influenza pandemic," eurosurveillance , no. ( ). pp. - . shah. p. . noddings. p. . tion that it is not possible to integrate and apply justice to care, such a limitation hardly applies to the context of a public health disaster such as pandemic influenza. for instance, the different conflicting priorities that arise during influenza outbreaks such as rationing of limited resources will be easier if some people are at least willing to forgo their interests for others. in non-familial carer and cared-for relationships involving at-risk government representatives and at-risk members of the society and familial relationships involving parents and children living in the same house, an appeal to a care ethical lens may help drive the moral sensitivity to the needs of others, enabling some vaccine-eligible persons (under the standard rationing criteria) to forgo their ration, preferring rather that other at-risk people (for example, ordinary people and younger family members) have them. this kind of selflessness approximates some form of humanitarian act in that person a decides to overlook their interests for others "without expecting rewards". however, because human beings naturally seek their own personal interests, there may be some difficulty in achieving this other-centric goal in as many people as possible in a public health disaster situation. this implies that the care ethical lens may have some limitations in relation to sufficiently engaging the ethical dilemmas raised by pandemic influenza in particular and other types of public health disasters, in general. that theme will, however, be addressed in chap. . during disasters, there is the utilitarian goal of doing the most good for as many people as possible with minimal harm. a people-oriented moral lens, this chapter argues, may be apt in accomplishing such an agenda. the chapter explored the strengths of the communitarian and care ethics moral lenses in relation to engaging the moral quandaries elicited during pandemic influenza outbreaks. because it is difficult to engage pandemic outbreaks with little prior preparation, these moral lenses become important since they can help people develop an other-centric orientation and sensitivity to the needs of others. to systematically drive the importance of a people-centered approach to pandemic influenza, this chapter explicated the biological make-up of the influenza virus as well as the social and global features of the associated pandemic. this helped underscore the local, regional, and global seriousness of pandemic influenza as a distinct type of public health disaster. the chapter went on to show how an barnes et al. p. . vawter, gervais, and garrett. p. . understanding of the social and biological dynamics of influenza has shaped the therapeutic and non-therapeutic approaches to engaging outbreaks. it also articulated some of the attendant limitations of pandemic influenza countermeasures including vaccines and anti-viral drugs. this chapter has also highlighted the ethical quandaries generated by influenza outbreaks. these are issues related to epistemic and social uncertainty, biological, social, geographical and political vulnerabilities, potential violations of human rights through some of the therapeutic and non-therapeutic countermeasures, as well as issues of local and global justice. against this conceptual background, the chapter pointed out how helping people is a central concern in pandemic influenza, and how the thorny ethical issues constitute difficulties encountered in accomplishing this goal. on that note, it showed how people-centered lenses such as communitarianism and ethics of care may be useful in engaging the associated practical and moral challenges. to clarify the importance of each of these approaches, the chapter elaborated each of these ethical lenses, and showed how each may help orient different players in the context of a pandemic influenza towards acquiring a sense of community and an other-centric sensitivity which will be 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lead poisoning outbreak in zamfara, nigeria: a multidisciplinary humanitarian response to an environmental public health disaster in a resource scarce setting ethical issues in pandemic planning monitoring the level of government trust, risk perception and intention of the general public to adopt protective measures during the influenza a (h n ) pandemic in the netherlands allocating pandemic influenza vaccines in minnesota: recommendations of the pandemic influenza ethics work group pathogenesis of the pandemic influenza virus h n influenza-continuing evolution and spread influenza in africa public health ethics: an update on an emerging field biological features of novel avian influenza a (h n ) virus key: cord- - px s c authors: hopkins, richard s.; magnuson, j. a. title: informatics in disease prevention and epidemiology date: - - journal: public health informatics and information systems doi: . / - - - - _ sha: doc_id: cord_uid: px s c this chapter provides a description of the components of disease prevention and control programs, and then focuses on information systems designed to support public health surveillance, epidemiologic investigation of cases and outbreaks, and case management. for each such system, we describe sources used to acquire necessary data for use by public health agencies, and the technology used to clean, manage, organize, and display the information. we discuss challenges and successes in sharing information among these various systems, and opportunities presented by emerging technologies. systems to support public health surveillance may support traditional passive case-reporting, as enhanced by electronic laboratory reporting and (emerging) direct reporting from electronic health records, and also a wide variety of different surveillance systems. we address syndromic surveillance and other novel approaches including registries for reporting and follow-up of cases of cancer, birth defects, lead poisoning, hepatitis b, etc., and population-based surveys (such as brfss or prams). systems to support epidemiologic investigation of outbreaks and clusters include generic tools such as excel, sas, spss, and r, and specialized tool-kits for epidemiologic analysis such as epi-info. in addition to supporting outbreak investigation, agencies also need systems to collect and manage summary information about outbreaks, investigations, and responses. systems to support case management, contact tracing, and case-based disease control interventions are often integrated to some degree with surveillance systems. we focus on opportunities and choices in the design and implementation of these systems. systems to support case management, contact tracing, and case-based disease control interventions are often integrated to some degree with surveillance systems. we focus on opportunities and choices in the design and implementation of these systems. public health programs to prevent disease typically have been designed and implemented one disease at a time. each disease has its own patterns of distribution in populations, risk factors, and optimal and practical intervention strategies that are effective in controlling, preventing, or even eliminating cases of the disease. for example, an important strategy to prevent measles is vaccination, the main strategy to prevent gonorrhea is antibiotic treatment of case contacts before they become ill themselves, an important strategy to prevent cervical cancer is screening with pap smears and treatment of preclinical disease, and the main strategy for prevention of neural tube defects is folic acid supplementation of selected foods. still, each disease prevention program's components are drawn from a relatively short list: • planning and evaluation • public health surveillance • outbreak or cluster recognition and response • policy and guidance development • clinical services -screening -immunization -prophylaxis -treatment • laboratory services • case-contact identifi cation and interventions • education and training for clinicians • public education • regulation (for example, of food services, drinking water, child-care centers, hospitals, etc.) • administration and fi nancial management ideally, program managers choose the most effective combination of these program components to prevent or control the disease or diseases they are charged with addressing. however, as this must be done within the constraints imposed by the available funds, cost-effectiveness is the usual criterion for choosing the preferred combination of program components. public health agencies typically are organized both by disease and by function. for example, each disease-specifi c program usually does not have its own laboratory, and a single public health clinical facility and its staff may provide varied services such as immunizations for well children, treatment of people with tuberculosis (tb) and their contacts, and pap smear services. to variable degrees, they may even combine activities in a single patient encounter, for example, testing women for gonorrhea and chlamydia trachomatis infections at the same visit where they get a pap smear, or offering hepatitis b vaccination during a visit for sexually transmitted diseases (std) treatment. as information technology has become more widely used in public health and replaced paper-based systems, it has typically been implemented program area by program area, as resources became available. this has led to the creation of information 'silos.' for example, laboratory information systems usually have developed in isolation from those to support clinical care or public health surveillance. information systems to support clinical operations of public health departments (for example, clinical services for stds, childhood immunizations, hiv/aids, tb, or family planning services) have characteristics similar to those of other electronic health record systems in ambulatory care. however, in some health departments, clinical information systems have been separated by disease or clinic. if one were to design information systems from scratch for a set of disease prevention programs, there would be potential savings and effi ciencies from identifying the ways that one program component depends on information from another, or can serve multiple programs, and then designing the system to provide that information seamlessly. one can identify potential effi ciencies from two perspectives: in reality, it is rare to have an opportunity to design such extensive information systems as a single project. one is dealing with numerous legacy systems that were designed to support program-specifi c workfl ows. so a key challenge for the public health informaticist is to help their agency make decisions about where information system 'integration' will yield substantial benefi ts and where it will not. for example, if it is desired to know (one time) how many people in the jurisdiction have been reported during a particular time interval with both syphilis and hepatitis b, one could do an ad hoc match of information in two independent surveillance information systems. this task might take an analyst a few days or weeks to accomplish -which is almost certainly inexpensive compared to the cost of building a new information system that could do this task almost immediately. for many purposes, it may be useful and suffi cient to be able to display multiple streams of surveillance or programmatic data in the same environment, on the same screen or even in the same chart. in florida, de-identifi ed reportable disease case information and death certifi cate information are imported into the essence analytic environment that was originally designed for syndromic surveillance [ ] , so that trends for similar conditions by age, sex, and geographic area in the two data streams can be easily compared. on the other hand, if it is desired to have real-time information available to the std clinic staff about past diagnoses of hepatitis b, or about past receipt of hepatitis b vaccine, then information systems need to be designed to support this kind of look-up; the usual solution is a shared person index between the two systems. alternatively, a common data repository can be designed in which all information about each person is permanently linked. as mentioned earlier, there are a number of components common to disease control and prevention programs. in this chapter, we will address information systems designed to support the following: • public health surveillance • outbreak or cluster recognition and response • acquisition of laboratory information • case-contact identifi cation and intervention cdc defi nes public health surveillance as "the ongoing, systematic collection, analysis, and interpretation of health data, essential to the planning, implementation, and evaluation of public health practice, closely integrated with the dissemination of these data to those who need to know and linked to prevention and control" [ ] . each word of this defi nition is carefully chosen, and has implications for the design of surveillance information systems. a one-time data collection activity is not surveillance. data collection for research purposes is not surveillance. surveillance data are collected to support public health action, and analyses and recommendations based on these data must be shared with those who provided the data and with others who need to know. objectives of surveillance systems differ at the local, state, and federal levels [ ] . at the local level, immediate response to individual cases is relatively more important, while at the federal level the analysis of larger-scale patterns is the most important function of surveillance. for state health departments, both uses of surveillance data may be important, depending on the disease and the size of the state. public health surveillance systems may be based on data capture from a variety of sources, including case reports, population-based surveys, sentinel providers, electronic health records (including laboratory information management systems for elr and emergency department records for syndromic surveillance), or administrative data (like hospital or physician claims for reimbursement). for some noninfectious diseases, surveillance is carried out through registries (see below). information systems to support reportable disease surveillance contain records representing case reports that currently are, for the most part, entered manually into an application by public health staff, based on information received from doctors, infection control practitioners, hospitals, and laboratories. increasingly, the laboratory information in these records comes from electronic records transmitted by the public health laboratory, hospital laboratories, and commercial laboratories, when there is a positive result meeting certain reporting criteria (like a positive igm antibody test for hepatitis a). these records typically contain a combination of clinical, laboratory, and epidemiologic information about each case. in future, increasing proportions of these case reports will be entered directly into a website by the practitioner creating the case report, or be transmitted electronically from the practitioner's electronic health record (ehr) system. currently almost half the states in the us use the cdc-provided nedss base system (nbs) as their platform for managing case reports. the remainder use either a system developed in-house or one of several commercially-available solutions [ ] . in case-based surveillance practice, there is usually a relatively short list of required elements in the initial case report. for some diseases this is the only information received on all cases. for other diseases, usually of more importance and with lower case numbers, an additional data collection form is initiated by the receiving health department, which gathers information as appropriate from the ill person, the treating physician, and health records. the optimum amount of information to collect in the initial case report, as opposed to the disease-specifi c case report form, is a matter of judgment and may change as technology changes. in a largely manual system, health departments typically desire to minimize barriers to reporting of cases, so the incentive is to keep the initial case report form short. if much of the information desired for the disease-specifi c case report form can in fact be extracted from an electronic medical record with no additional effort by the person making an electronic case report, then the balance changes. careful decisions are needed: for which cases of which diseases are follow-up interviews necessary [ ] ? until very recently, virtually all of the case-based surveillance information used at the federal level was collected initially at the local (or sometimes state) level, where it was used in the fi rst instance for local response. as the case report information passes from the local to the state to the federal level, it is subjected to validation and cleaning: cases not meeting the surveillance case defi nition have been removed from the data submitted to the federal level, missing data have been fi lled in to the extent possible, and cases have been classifi ed as to whether they are confi rmed, probable, or suspected using standard national surveillance case defi nitions (these case defi nitions are developed by the council of state and territorial epidemiologists in consultation with cdc) [ ] . more recently, advances in technology have allowed case reports, and the information on which they are based, to move almost instantaneously from electronic health record systems, maintained by doctors, hospitals, and laboratories, to public health authorities. there are no technical barriers to these data being available at the federal level essentially as early as they are at the local and state levels. this ready availability of unfi ltered clinical information may allow more rapid awareness by public health offi cials at all levels of individual cases of high-priority diseases (like botulism or hemorrhagic fevers like ebola virus infection), and thus lead to more rapid detection and characterization of likely outbreaks. the simultaneous availability of raw data to multiple agencies at different levels of government also presents certain challenges. the user at the local level will have ready access to information from many sources about local conditions and events, and can use this information to interpret local observations. they will be in a position to understand when an apparent anomaly in their surveillance data is due to an artifact or to local conditions that are not a cause for alarm. they will also know whether a problem is already under investigation. a user at a state or federal level will be able to see patterns over a larger area, and thus may be able to identify multijurisdictional outbreaks, patterns, or trends that are not evident at a local level. the fact that several users may be examining the same raw data at the same time requires that these multiple users be in frequent communication about what they are seeing in their data and which apparent anomalies are already explained or need further investigation. there is a danger that users at a higher level may prematurely disseminate or act on information that, while based on facts, is incomplete or misleading. similarly, users at a local level may not realize that what they are seeing is part of a larger phenomenon. in the syndromic surveillance domain, the biosense . governance group [ ] has adopted a set of etiquette principles which participating jurisdictions will be required to agree to, that spell out the mutual obligations of analysts at each level of the system (scott gordon , association of state and territorial health offi cials, , personal communication). from an information management perspective, an important question is where to put human review of case reports in this information fl ow. for example, it is becoming technically possible for likely cases of reportable diseases to be recognized automatically in health care electronic record systems. some of these could be passed on to public health authorities without human review, in the same way that reportable laboratory results are already passed on in electronic laboratory reporting (elr). for which constellations of fi ndings in the electronic health record would this be appropriate? should some electronic case reports generated by electronic health record systems be passed to state or even federal public health offi cials before they are reviewed and validated at the local or state levels? if so, which ones? as always, there is a tension between the speed of information fl ow and its quality and completeness. there is a need for research to determine which constellations of fi ndings in electronic health records have adequate specifi city and sensitivity to warrant automated identifi cation of a person as being likely to have a case of a reportable disease. the acceptable sensitivity and specifi city will vary by disease. in , cdc published the updated guidelines for evaluating public health surveillance systems [ ] . this document identifi es a set of key attributes of surveillance systems to be assessed during a surveillance system evaluation, including simplicity, fl exibility, data quality, acceptability, sensitivity, predictive value positive, representativeness, timeliness, and stability. these are also useful attributes to consider when designing a surveillance information system [ ] . the relative importance of these attributes will vary depending on the condition under surveillance and the main purposes for surveillance. for example, a surveillance system to detect cases of botulism for immediate public health response puts a high premium on timeliness, and its operators are likely to be willing to accept a modest number of false-positive reports (a lower positive predictive value ) in order to assure that reports are received very quickly. on the other hand, surveillance to support planning of cancer prevention programs and treatment services is less time-sensitive, given the quite long incubation periods for most cancers, and therefore more concerned with diagnostic accuracy of every case report than with speed of reporting. timeliness, positive predictive value, and sensitivity of a public health surveillance system are always in tension with each other; increasing two of these always compromises the third. in systems based on case-reporting from doctors, hospitals, and laboratories, and receipt of electronic health records from these same organizations, records for an individual can in principle be linked with records for that same individual in numerous public health information systems, including those supporting clinical service, immunization registries, case investigation, partner or contact identifi cation, partner or contact notifi cation, and provision of interventions to partners or contacts. sometimes this will be done best by automated messaging of structured data from one system to another, sometimes by supporting real-time look-up capabilities, and sometimes by development of a master person index to underlie some or all of these applications. one key decision is which application to consider as the hub for this information sharing, for example, the surveillance application itself or a clinical application. surveillance systems that are based on sample surveys (such as the behavioral risk factor surveillance system, brfss [ ] ), on sentinel practices (such as ili-net for surveillance of infl uenza-like illness [ ] ) or on syndromic surveillance do not have individual patient identifi ers, and so intrinsically cannot be linked at the individual level to information systems supporting other disease control program components. their data are typically managed in systems built on standard statistical software packages, or other independent systems. syndromic surveillance systems are based on rapid acquisition of unfi ltered, real-time, electronic records without individual identifi ers from hospital emergency rooms [ ] and urgent care centers, and also, increasingly, from outpatient physicians' offi ces and from hospital admissions [ ] . the primary purpose of these systems is to support detection and characterization of community disease outbreaks, as they are refl ected in care received at emergency departments, physicians' offi ces, or hospitals. each visit to an emergency department is assigned to a category or syndrome , based on words and strings contained in the patient's chief complaint and/or the triage nurse's notes. as the records received by the health department do not have individual identifi ers, they cannot be linked to records in other information systems. however, records received by the syndromic surveillance system should contain unique identifi ers that could allow the epidemiologist analyzing the data to work back through the sending facility to an identifi ed clinical record. this traceback might become necessary if the person appeared to have a case of a reportable disease or to be part of a signifi cant outbreak. adding outpatient visits and hospital admissions to the scope of syndromic surveillance is opening up additional uses for this technology, especially in the areas of real-time non-infectious disease surveillance. surveillance for cancers [ ] , stroke [ ] , birth defects [ ] , and some other chronic diseases like amyotrophic lateral sclerosis (als) is carried out through registries. registries are usually established by specifi c legislation, and typically relate to a single topic -for example a registry of records for a disease, or of immunization records. registries may be restricted to a geographic region. a distinctive feature of registries is that individual case reports are kept open for long periods of time, up to several or many years, allowing additional information about treatment, hospitalization, and death or other outcomes to be added. registries thus serve as systems to monitor type, duration, and outcome of treatment for these diseases, in addition to the occurrence of new cases of disease (disease incidence ). they may also support outreach efforts to patients or their families, as a way to document that appropriate steps have been taken to link patients to needed types and sources of care. most cases recorded in state-level cancer registries are acquired from hospitallevel registries, using an electronic case report in a standardized format [ ] . some case abstracts are obtained directly by registry personnel or contractors, when hospitals do not have suitable registries of their own. case reports require extensive review and abstraction of medical records by trained workers. birth defect registries may also be built by active search for cases in hospital and other medical records, and abstraction of those records to make case reports. they also may be built by electronically linking records from vital statistics (birth and death records), centralized hospital discharge record systems, and clinical service providers for children with birth defects (such as state programs for children with special medical needs) [ ] . the latter are much less expensive to develop but cannot be assumed to have captured all cases of the disease under surveillance, or captured them correctly [ ] . a disease outbreak is defi ned as a number of cases greater than the number expected during a particular time interval in a geographic area or population. this term usually is used for events due to infectious diseases, and sometimes for those of toxic origin. a similar increase above expected numbers for a non-infectious disease, such as birth defects or cancer, is usually called a cluster . outbreaks and clusters may be due to diseases for which individual cases are reportable (like shigellosis or breast cancer), or diseases for which they are not (like food poisoning due to staphylococcal or clostridium perfringens toxins in most states, sars when it was new, or multiple sclerosis). surveillance systems are designed to facilitate recognition of outbreaks or clusters by frequent examination of the most current information available. the design of the user interface is particularly important. the interface should allow users to: fl exibly display line lists, bar charts by date of event (epidemic curves), and maps of location of cases; fl exibly select subsets of cases for display; apply appropriate statistical tests to detect improbable increases in case counts; and display multiple streams of data on the same chart. for example, users may want to display the epidemic curve of an infl uenza outbreak for several different regions of a state or for several different age groups, or to display counts of positive infl uenza tests and emergency department visits for infl uenza-like illness on the same graph with different scales for each. syndromic surveillance systems have been leaders in developing and evaluating statistical algorithms for automated detection of anomalies which may, on investigation, turn out to be outbreaks. such algorithms have less frequently been applied for automated detection of possible outbreaks or clusters in reportable disease data streams. most outbreaks and clusters are in fact not recognized by examination of regularly-collected surveillance system data. instead, they are recognized by private citizens (such as the organizer of a social event, a teacher or school nurse, the manager of a child care center, the manager of a food service facility, an employer, or the ill people themselves) or by practicing doctors, and brought to public health attention via a phone call or e-mail or entry on a web site established for the purpose [ ] . public health workers assess the information and make the decision whether or not to do a formal investigation of the outbreak. one part of such an assessment is to look at available streams of surveillance data and determine whether there is information supporting the occurrence of an outbreak. for example, a report of a possible infl uenza outbreak in a high school might prompt closer examination of syndromic surveillance data from nearby hospital emergency departments to determine whether there is a more general increase in visits for infl uenza-like illness. a report of a neighborhood cluster of brain cancers would prompt closer examination of available cancer registry information, which might or might not support an interim conclusion that such a cluster is real and statistically signifi cant. in order to be accountable for the effectiveness of their work, local and state health departments need to track the occurrence of outbreaks and the public health response to those outbreaks. since outbreaks can be due to reportable or nonreportable diseases, this cannot be done only by actions such as identifying some cases in the reportable disease data system as being part of an outbreak. systems to track the occurrence of outbreaks need to document the following: • time and date the fi rst and last cases occurred • total (estimated or counted) number of cases • population group most affected (by age, sex, location) • setting of the outbreak (school, workplace, restaurant, wedding, etc.) • suspected or confi rmed agent • most common clinical presentation • suspected or confi rmed source and mode of spread • methods used to investigate agent, source and mode of spread • control measures recommended • control measures implemented • lessons learned for prevention of future outbreaks and improved investigation and response in future events this information about outbreaks should be stored for ready retrieval, and to serve as a basis for quality improvement efforts. for quality improvement purposes, it is also helpful to document the content of the summary report written about each outbreak. when the outbreak is due to a reportable disease, individual cases in the reportable disease surveillance information system can be linked to the outbreak, for example by having an outbreak identifi er attached to their records. if preliminary information about outbreaks in a jurisdiction is entered into the outbreak information system in real time, as the investigation is proceeding, and if the outbreak database is readily searchable by all communicable disease investigators in the jurisdiction, then local investigators can use the outbreak database to help them with investigations of new illness or outbreak complaints [ ] . for example, if they receive a complaint that illness has occurred in people who consumed a particular food product, they can look in the database and determine whether other recent or current complaints or outbreaks mention the same food product. if they receive a report about a gastroenteritis outbreak in a childcare center, they can determine what agents have been found to be responsible for recent or current similar outbreaks in nearby communities; this can help focus their laboratory testing and initial control strategies. some us states have had long-standing systems to document all outbreaks investigated by local or state personnel, but others have not. a major variable in the design of such systems is the state-local division of responsibilities in each state, including the degree of state oversight of 'routine' local outbreak investigations. the actual investigation of an outbreak or cluster may involve enhanced "active" case-fi nding, use of case-report forms, group surveys, and formal epidemiologic studies. active case-fi nding involves regular solicitation of case reports from doctors, hospitals, and laboratories. managing the reports of possible, probable, and confi rmed cases that are part of the outbreak is an important task. for a reportable disease, the jurisdiction's reportable disease surveillance system may be adequate to manage reported cases. it may be necessary, however, to create a continuouslyupdated line list of possible cases and their current status, which is outside the scope of the standard reportable disease application. outbreak investigation surveys will typically involve interviewing everyone with a possible exposure (like all attendees of a wedding reception), whether they were ill or not. formal studies may involve interviewing selected non-ill people, for example, as part of a case-control study. the investigation may also involve obtaining and sending to a laboratory a large number of specimens from ill persons, and sometimes from exposed non-ill persons and from environmental sources (food, water, air, soil, etc.). managing these disparate types of information is a challenge, especially in a large outbreak or one involving multiple jurisdictions. there is currently no one widely-accepted and satisfactory way to manage data in such settings. each investigation team typically uses the tools it is most familiar with, including some combination of data management tools like ms excel, ms access, or epiinfo [ ] , and standard statistical packages. many health departments maintain libraries of standard questionnaires with associated empty data bases, for use during outbreak investigations. when cdc is involved in a multistate outbreak, the investigation team at the local or state level needs to be able to produce and transmit timely case report and other information in the format desired by cdc. the services of an experienced public health informaticist can be extremely helpful to the investigation team when outbreaks are large and multifocal. an ongoing challenge for cdc and the states is how to make the transition from specialized case reporting during an outbreak of a new disease, such as west nile virus encephalitis or sars, to routine case-based surveillance. if this transition is not well-managed, it is likely to result in the creation of a permanent stand-alone surveillance information system (or silo) for that disease. if the new disease is of national importance, cases should be made nationally notifi able and its surveillance should be incorporated into existing systems. laboratory information is a critical component of disease surveillance and prevention. laboratory data form the foundation of many surveillance systems. there are different types of laboratories involved in the public health data stream. laboratories providing data to public health fall into the general categories of commercial or private industry, hospital or clinical, and public health laboratories. public health laboratory information systems (lis) contain information about test results on specimens submitted for primary diagnosis, for confi rmation of a commercial or hospital laboratory's results, for identifi cation of unusual organisms, or for further characterization of organisms into subgroupings (like serotypes) that are of epidemiologic importance. in some states, all clinical laboratories must submit all isolates of certain organisms to the public health laboratory. many of the results obtained in a public health laboratory turn out to be for diseases that are not reportable and not targets of specifi c prevention programs. some of those results may, however, be for cases of non-reportable diseases that are historically rare in the jurisdiction but of great public health importance, or are new or newly-recognized. the main business of clinical laboratories (located both inside and outside hospitals) is to test specimens for pathogens or groups of pathogens specifi ed by the ordering physician, and return the results to the person who ordered the test. public health agencies have, since the early s, asked or required such laboratories to also identify results meeting certain criteria (indicating the presence of a case of a reportable disease) and send a copy of the results to the public health agency for public health surveillance. initially, case reporting by laboratories was accomplished on paper forms, which were mailed or faxed to public health departments. some laboratories very soon moved to mailing printouts of relevant laboratory results, then to sending diskettes, then to transferring computerized fi les containing laboratory results by direct modem-to-modem transfer, and eventually to transferring such fi les via the internet using standard formats and vocabularies. in some states, public clinics (for example, std clinics) have used contract laboratories for their testing needs. in this situation, the outside laboratory supplies both positive and negative results to the public health agency, increasingly by transfer of electronic results in standard formats. laboratories provide data on reportable conditions to their local or state public health authority. reportable diseases are determined by each state; clinicians, hospitals, and/or laboratories must report to public health when these conditions are identifi ed. some reportable conditions are also nationally notifi able. deidentifi ed cases of these are voluntarily notifi ed by states and territories to cdc, which, in collaboration with the council of state and territorial epidemiologists, maintains a listing of nationally notifi able conditions that includes both infectious (e.g., rabies, tb) and non-infectious (e.g., blood lead, cancer) conditions [ ] . the public health partnership with laboratories has led to the very successful and still increasing implementation of electronic laboratory reporting (elr) in the us. elr refers to the secure, electronic, standards-based reporting of laboratory data to public health. elr implementation has been steadily escalating since its inception around the year , replacing previous reporting systems that relied on slower, more labor-intensive paper reporting. the elr national working group conducted annual surveys from to [ ] which gathered data from all states as well as from several territories and large metropolitan areas. these data were supplemented with data for years - , retroactively gathered in the survey. the tracked growth of elr (fig. . ) illustrates its rapid rise in the us, from the start of early stage planning to fully operational elr [ ] . the expected benefi ts of elr include more rapid reporting of reportable cases to public health departments, allowing faster recognition of priority cases and outbreaks for investigation and response, and thus more effective prevention and control [ ] . elr also is expected to reduce the number of missed cases, as automated systems do not require laboratory staff to actively remember to make case reports, and to improve the item-level completeness and quality of case reports. although experience shows that the expected improvements in timeliness, sensitivity, completeness, and accuracy are generally being realized [ ] , timeliness may not be improved substantially for those diseases where clinicians routinely report based on clinical suspicion without waiting for laboratory confi rmation (for example, meningococcal disease) [ ] . in addition, laboratories (especially referral laboratories) often do not have access in their own information systems to home addresses for people whose specimens they are testing, and have struggled with providing complete demographic information to public health agencies. implementation of an operational elr system is not a trivial undertaking. laboratories must confi gure data into an acceptable message format, most commonly health level seven (hl ® ) [ ] . laboratory tests and results should be reported with correlated vocabulary or content codes. two of the most common code systems used for laboratory tests and their associated results are logical observations identifi ers names and codes (loinc ® ) [ ] and systematized nomenclature of medicine (snomed ct ® ) [ ] . neither of these systems is suffi cient by itself to encode all the information needed for public health surveillance. public health jurisdictions have introduced elr to their partner laboratories using one or more of the following approaches: • the "charm" approach -relies on establishing goodwill and collaboration with laboratory partners. while this collegial approach is very appealing, it may be unable to overcome signifi cant barriers such as lack of laboratory funding or resources, and some facilities will supply data only in methods specifi cally required by law. • the incentive approach -involves offering either fi nancial or technical assistance to laboratory partners, assisting them in the startup process of elr. while this approach may be preferred by many laboratories, relatively few jurisdictions have the discretionary funds (or are able to receive federal assistance funds) to implement the approach. • the enforcement or legislative approach -requires reporting rules or legislation that requires laboratories to participate in elr. the most successful enforcement approach will include low-cost options for smaller laboratories, such as web data entry, so that they may benefi t from an elr -"lite" implementation [ ] . the mainstreaming of elr systems in the us has pioneered a clear path forward for public health to begin maximizing its presence in the domain of electronic data interchange. at a local level, case reports for communicable diseases prompt action. although the specifi c action varies by disease, the general approach is the same. it starts with an interview of the ill person (or that person's parents or other surrogates) to determine who or what the person was in contact with in ways that facilitate transmission, both to determine a likely source of infection and to identify other people who may be at risk from exposure to this person. information systems to support contact tracing, partner notifi cation, and postexposure prophylaxis (for stds or tb, for example) contain records about all elicited contacts (exposed persons) for each reported case of the disease in question. these records contain information about each contact, such as whether they were located, whether they received post-exposure prophylaxis, and the results of any additional partner-elicitation interviews or clinical testing that were completed. information systems to support surveillance for other reportable diseases also increasingly contain information about what disease-appropriate action was taken in response to each case; such actions may include identifi cation of contacts, education of household members, vaccination or antibiotic prophylaxis of contacts, isolation of the case (including staying home from work or school), or quarantine of exposed people. std and tb information systems typically capture full locating information for contacts, and can be used both to support fi eld work and to generate statistics on effectiveness of partner notifi cation activities worker by worker and in the aggregate. systems for other reportable diseases may capture only the fact that various interventions were done, and the date that these were initiated. information about the timeliness of initiation of recommended control measures is now required as a performance measure for selected diseases by cdc's public health emergency preparedness cooperative agreement [ ] . in the investigation of a case of meningococcal disease, contacts are people who had very close contact with the original person, for example a household member, boyfriend, or regular playmate. health department staff determines who the close contacts are. each will then be offered specifi c antibiotic treatment to prevent illness. for syphilis, contacts are people who have had sex with the original case. contacts will be examined by a clinician and assessed serologically to see if they are already infected, and offered appropriate prophylactic or curative antibiotic treatment. for measles, contacts may include anyone who spent even a few minutes in the same room as a case. contacts whose exposure was recent enough, and who are not fully immunized already, will receive a dose of measles-containing vaccine, and all contacts will be asked to self-isolate immediately if they develop symptoms of measles. in investigating a common-source outbreak of legionellosis, histoplasmosis, or anthrax, the local health department may want to locate everyone who had a specifi ed exposure to the apparent source of the infection. these exposed people may need antibiotic prophylaxis or may be advised to seek medical care promptly if they become ill. information systems to support this type of work typically have three purposes: . serve as a place for workers to record and look up information about people who are or may be contacts, and to track which contacts have and have not yet received needed interventions. . serve as a source of information for calculating indices of program or worker timeliness and performance, such as the average number of sexual contacts elicited per syphilis patient interviewed, or the percentage of measles contacts who were identifi ed in a timely way and who received post-exposure measles vaccine prophylaxis. . document the workload and effort put in by epidemiology and disease control fi eld staff it seems logical that the surveillance information system should serve as the basis for a system to support fi eld investigation, and this is often the case. the fact that the recommended interventions vary by disease makes designing a single system more complex. existing systems that track fi eld worker activities in detail are much more common for std and tb programs than for others. for general communicable disease fi eldwork, it is currently more common that the system simply documents which interventions were done and when, rather than use the application to track specifi c named contacts or exposed people. the public health informatics institute has published a detailed analysis [ ] of the typical workfl ow involved in surveillance, investigation, and intervention for reportable diseases, and the corresponding information system requirements. the work group that phii convened had representatives of nine different state and local health departments, who were able to identify a large number of processes that were common to all nine jurisdictions, such as case-fi nding, case investigation, data analysis and visualization, monitoring and reporting, case/contact specifi c intervention, and others. these common processes can then serve as a basis for designing information systems to support case-reporting, surveillance, and case-based intervention work that are useable in multiple jurisdictions. consider existing or planned surveillance systems for multiple diseases and conditions. broadly, there are three functions in each of these systems -acquiring the raw data, cleaning and managing the data, and making the data available to users. each of these functions potentially can be integrated, to varying degrees. for example, multiple surveillance systems may benefi t from receiving electronic laboratory reports with a result indicating the presence of a case of a reportable disease. laboratories appreciate having a single set of instructions and a single destination for all their required reports, as this simplifi es their work. the laboratories then benefi t from the ability of the recipient health department to route the reports internally to the right surveillance information system. at the other end of the data pathway, users appreciate having a single interface with which to examine data about multiple conditions or diseases, using the same commands and defi nitions. the users do not have to understand how different surveillance information systems may internally code the same concept in different ways. they also appreciate being able to directly compare information that originally was submitted for the use of different program areas -for example, hepatitis b and gonorrhea in the same chart or table. in the short to medium term, it is not necessary to build a single integrated data repository or a master person index to achieve these goals, even if that is what one would have designed if one were starting from the beginning. however, if one wants to be able to see information about the same person that originates and is stored in multiple systems -for example, so that tb clinicians can see hiv data on their patients and vice versa -then an integrated data repository, or a master person index, or a query system that is extremely accurate in fi nding data on the right person, is needed. modifying existing systems to be able to carry out these functions is time consuming and expensive, so the business case and requirements need to be especially clear. florida's essence system: from syndromic surveillance to routine epidemiologic analysis across syndromic and nonsyndromic data sources (abstract) history of public health surveillance blueprint for a national public health surveillance system for the st century status of state electronic disease surveillance systems -united states prioritizing investigations of reported cases of selected enteric infections. paper presented at council of state and territorial epidemiologists nationally notifi able disease surveillance system case defi nitions association of state and territorial health offi cers. biosense . governance updated guidelines for evaluating public health surveillance systems, recommendations from the guidelines working group design and operation of local and state infectious disease surveillance systems oxford handbook of public health practice behavioral risk factor surveillance system overview of infl uenza surveillance in the united states international society for disease surveillance meaningful use workgroup. final recommendation: core processes and ehr requirements for public health syndromic surveillance electronic syndromic surveillance using hospital in patient and ambulatory clinical care electronic health record data national program of cancer registries coverdell national acute stroke registry surveillance -four states atlanta congenital defects program (macdp) north american association of central cancer registries, inc. (naaccr). implementation guidelines and recommendations report on birth defects in florida a comparison of two surveillance strategies for selected birth defects in florida online food and waterborne illness complaint form biosurveillance plan for human health, version . . atlanta national notifi able diseases surveillance system (nndss), cdc. accessed at http:// wwwn.cdc.gov/nndss/ on available from www.coast coastin-formatics.com national electronic laboratory reporting (elr) snapshot survey. available from www.coast coastinformatics.com . cited statewide system of electronic notifi able disease reporting from clinical laboratories: comparing automated reporting with conventional methods a comparison of the completeness and timeliness of automated electronic laboratory reporting and spontaneous reporting of notifi able conditions potential effects of electronic laboratory reporting on improving timeliness of infectious disease notifi cation -florida health level seven (hl ® ) homepage. available at logical observation identifi ers names and codes (loinc ® ) systematized nomenclature of medicine-clinical terms (snomed ct ® ) see for example section d- . ( ) of the florida administrative code: notifi cation by laboratories public health emergency preparedness cooperative agreement, budget period , performance measures specifi cation and implementation guidance, at-a-glance summary redesigning public health surveillance in an ehealth world on . what are some of the methods for surveillance besides case-reporting? . how are registries different from other surveillance information systems? . what are the advantages and disadvantages of building a master person index across surveillance information systems for multiple diseases? . what are the expected benefi ts of electronic laboratory reporting as a method to enhance surveillance? . what are the advantages and disadvantages of building a system to manage information about case contacts as part of the surveillance information system? . who determines for which diseases cases are nationally notifi able? key: cord- -b x x f authors: soleimanpour, samira title: school-based health centers: at the intersection of health and education date: - - journal: j adolesc health doi: . /j.jadohealth. . . sha: doc_id: cord_uid: b x x f nan school-based health centers: at the intersection of health and education school-based health centers (sbhcs) have emerged over the last years as a cost-effective service delivery model that improves health care access and outcomes for youth, particularly those in underserved communities [ , ] . there are more than , sbhcs throughout the u.s., providing access to care for approximately % of public school students on or near their school campuses [ ] . sbhcs provide primary and preventive health care, often in combination with mental health, reproductive health, vision, and dental care, as well as broader services to the school community through youth development programs, health education, and school staff supports [ ] . by bringing health services to the school setting, where youth spend a large portion of their time, sbhcs overcome barriers that prevent youth, especially the most vulnerable, from receiving needed health care services, including transportation, time, costs, and confidentiality concerns. in fact, minority youth have been found to use sbhc services more frequently than other community health delivery sites, particularly mental health care [ ] . yet, the placement of sbhcs in schools introduces a level of accountability that other pediatric and adolescent health providers are seldom held toedemonstrating their impacts on youth's educational achievements. despite the existing research showing the impacts of sbhcs on academic outcomes, including saved classroom instruction time, improved grade point averages, and reduced disciplinary actions [ ] , many stakeholders in both the health and education fields continue to wonder if sbhcs can more directly document their academic impacts and justify their presence in schools. sbhcs by design are often located in higher needs areas where communities face significant barriers. recent data show that sbhcs serve schools with higher proportions of socially and economically disadvantaged youth compared with schools without sbhcs [ ] . these youth also have disproportionate academic experiences [ ] because of structural inequalities that are far beyond the scope of what sbhc services can influence, which makes the burden of demonstrating impacts on educational success, in addition to health outcomes, an even greater challenge. researchers have historically struggled to conduct studies linking sbhcs to improvements in youth's academic outcomes largely because of methodological challenges of small sample sizes, inherent differences in sbhc users and nonusers, and issues linking health and education data that are each protected by separate federal regulations (the health insurance portability and accountability act for health data and the family education rights and privacy act for education data) [ ] . however, there is a growing body of research that moves away from looking at individual-level effects and focuses on school-level effects. schoollevel studies have their own challenges, mainly the lack of ability to control for external or unobserved factors, and findings have been mixed [ , e ]. yet, the desire for a more rigorous study in this area persists. in their article, westbrook et al. [ ] take a school-level approach to assessing sbhcs' effects on high school graduation rates. using public data from colorado high schools that opened sbhcs over an -year period, they found that sbhc schools showed a larger percentage increase in graduation rates, with larger increases in male graduation rates, in particular. although the differences detected were modest, their study design lays a framework for future studies to refine and replicate, and their findings help to potentially strengthen the argument that sbhcs can contribute to educational achievement. the schools that westbrook et al. studied had larger minority and free and reduced lunch eligible populations and lower graduation rates before sbhcs opening, similar to sbhcs nationwide. the fact that they found increases in graduation rates in these schools advances the knowledge of potential contributions of sbhcs in decreasing inequalities. further inquiry into the effects on graduation rates among ethnic groups would be helpful if these data were available. westbrook et al. also found that male graduation rates increased significantly, but not female graduation rates. recent data show that high school sbhc users are more likely to be female [ e ], which would lead to the hypothesis that observed effects should have been larger among females. although it was not within the scope of their study to explore explanations for these effects, it would be interesting to examine the relationships between services offered and service utilization by gender and academic outcomes. this highlights a chronic challenge that has plagued sbhc research, which is defining exposure to the intervention. there can be great variation in the types and dosages of interventions that each sbhc offers, from varying hours when medical, mental health, and other providers are available to the degree of coordination of care between providers or integration into the school campus, as well as in the specific interventions that individual youth receive from the sbhc. this variation must be acknowledged and accounted for in any analysis of impacts on academic outcomes to help clarify the intricacies of the relationships between sbhcs and education. the work of westbrook et al. provides a meaningful contribution to the literature by looking at graduation rates before and after sbhcs were opened over a nearly -year period. they raise www.jahonline.org important directions for future inquiries to take, including to "unpack the mechanisms through which sbhcs influence educational outcomes" and determine which services and demographic characteristics influence these mechanisms. the health care and education landscapes are changing rapidly, especially due to the coronavirus disease pandemic and resulting school closures, which have exacerbated disparities in both arenas. as policymakers decide how to allocate scarce resources in the future, research on the contributions of sbhcs to both health and education can strengthen the evidence base needed to justify investments into sbhcs' maintenance and expansion to support youth and address inequities. there is no funding associated with this publication. school-based health centers to advance health equity: a community guide systematic review community preventive services task force. economic evaluation of school-based health centers: a community guide systematic review twenty years of school-based health care growth and expansion school-based health centers in an era of health care reform: building on history use of health and mental health services by adolescents across multiple delivery sites race and economic opportunity in the united states: an intergenerational perspective school-based health center use and high school dropout rates-reply impact of school-based health center use on academic outcomes school-based health services and educational attainment: findings from a national longitudinal study the influence of school-based health center access on high school graduation: evidence from colorado mental health characteristics and health-seeking behaviors of adolescent school-based health center users and nonusers the role of school health centers in health care access and client outcomes academic, psychosocial, and demographic correlates of school-based health center utilization: patterns by service type key: cord- -g p lgmn authors: ratshidi, lilies; grobbelaar, sara; botha, adele title: categorization of factors influencing community health workers from a socio-technical systems perspective date: - - journal: responsible design, implementation and use of information and communication technology doi: . / - - - - _ sha: doc_id: cord_uid: g p lgmn in low-and-middle-income countries (lmics), community health workers (chws) are often seen as a connecting bridge between two dynamic and overlapping systems- the community and formal health systems. although the importance of chws is acknowledged, there is minimal aggregated evidence contributing towards understanding their position, technological capabilities, barriers and facilitators of their effectiveness in the south african context. despite the widespread enthusiasm around the potential that mobile health (mhealth) technology holds in extending healthcare through chw to underserved communities, an understanding of mhealth’s various implications in a developing world context is imperative to appreciate both the community and health systems context. the chws within this context need to assume multiple roles as they work and live amongst and in the community. the study argues that by examining their multiple roles as part of the healthcare continuum and from within the community setting, appropriating technological solutions can be conceptualized to facilitate and enhance their impact and visibility. this research article then aims to articulate the key conceptual factors which should be considered when implementing technological solutions for chws within the south african context. the aim is operationalized by means of the best-fit framework synthesis method to explore the body of knowledge towards presenting a conceptual understanding through a categorization of factors influencing community health workers from a socio-technical systems perspective. the constitution of south africa enshrines the provision of healthcare access as a basic human right for all its citizens. however, the south african healthcare system is fraught with challenges, some of the major ones include the inadequacy of human and equipment resources [ ] , difficulties in synergizing and collaborating policies and lack of legislative commitment to improving the public health sector [ ] . according to the world health organization, the shortage of healthcare workers is a major challenge in a country's ability to overhaul its healthcare system and ultimately, achieve universal healthcare coverage [ ] . given south africa's limited resources, the need for costeffective strategies is paramount. recent studies [ , ] identify an adequately competent workforce with multi-faceted roles as having the potential to relieve some of the healthcare system burdens by bridging the healthcare equity gap. several authors [ , , ] have suggested that chws as a workforce could be beneficial in the south african context. in addition, it is noted that chws are considered a dependable vehicle to provide quality contextual health services both in urban and rural settings within the south african context [ ] . the south african government has introduced various initiatives to address the historic disparate healthcare system [ ] . one such initiative is the national development plan for that involves building human resources to ensure shared competencies for the health system as part of its plan of action. part of this plan includes a goal of employing and training between and . million chws to implement community-based primary healthcare [ ] . regardless of the effort needed to reach this goal quantitively, it can be argued that the potential benefits of chws have not to be realized. this can be attributed to a misalignment in national policies and standards to their work practices, and the significant barriers in training chws to function at the expected level of competence [ , ] . with the widespread use of mobile technology in sub saharan africa over the past years, there is an estimated increase to % of mobile internet penetration [ ] . there is mounting evidence that suggests the use of mobile health has the potential to enable chws to mitigate some of the challenges faced [ ] . consequently, the utilization of technology as a viable solution for chws has steadily gained significant popularity. despite this, various authors' calls for research specifically focused on investigating mhealth implementation for chws in low-and-medium-income countries (lmics). the definition of lmics adopted was according to the world bank classification with the study focusing more on the sub-saharan region [ ] . winters et al. [ ] articulate this as a call for more robust evidence on mobile technology implementation strategies as a means of supporting chw practices [ ] . granja et al. [ ] suggest the successful implementation of technological solutions interventions can be improved through the identification of factors that influences the intervention's outcomes. from these insights, it can be inferred that an in-depth understanding of the healthcare domain and the processes of technology adoption and use by chw are a needed step towards achieving the full potential of mhealth. in this regard, various studies have identified factors influencing chws. these factors include their perceived performance, motivation and job satisfaction [ , ] . however, verification of how these factors affect the implementation and evaluation of technological solutions for lmics has not sufficiently been documented. this study aims to articulate the key conceptual factors which should be considered when implementing technological solutions for chws within the south african context. the paper outline is as follows: method, descriptive statistics of the results, discussion and construction of the framework, and the conclusion. the study is grounded in social and technical perspectives as it facilitates the duality of the chws' work and community role, further adopts the technique of the "best-fit" framework synthesis method in the exploration. the best-fit framework synthesis is defined in [ ] as "a means to test, reinforce and build on an existing model, conceived for a potentially different but relevant population". this method involves creating or employing a framework with priori themes and using it to code the data obtained from the relevant studies as a means to produce a rapid and pragmatic form of synthesis [ ] . it advises the use of criteria; one for identifying the models and theories to generate a priori framework, and one for populating the scoping review of primary qualitative research studies. in this study, only one set of the literature search and a study selection was considered for the scoping review as the socio-technical system (sts) framework was used as a priori framework. figure illustrates the methodology approach applied. davis et al. [ ] describes the sts framework as a system which considers the people involved with distinct social behaviors and skills, working within a physical infrastructure, using a range of technologies and tools to achieve a set of goals and metrics by following sets of processes and practices under a set of cultural assumptions and norms [ , ] . sts is defined as an approach to complex work design consisting of technical systems; social systems with an interplay of human agents employing social dependencies that either hold or emerge between them; and finally, organizations that are heterogeneous within unpredictable operational environments, which are autonomous and poorly controllable [ ] . the sts theory premises on the combination of social and technical aspects to design a functional work system that can cope with the complexities of the environment within which the system operates in, as well as the dynamics introduced by new technological interventions [ ] . hence, to account for the delicate dynamic relationships within the chws' work system, the sts framework was used to diagnose, identify and categorize the literature into the factors and interactions between the social and technical elements, and a summary of the study characteristics was transferred to excel for further synthesis, where they were categorized as either technical or social to generate key inferences regarding the factors which should be considered. the six interrelated elements used are people, infrastructures, goals, technologies, culture, and processes embedded within an external environment [ ] . having overviewed the methodology approach the following section outlines the search strategy employed. in [ ] , six interrelated elements were presented in the conceptualization of an sts and were used to evaluate the initiatives documented in the literature, from which relevant factors related to each element were identified. a broad literature search was conducted on scopus, google, research gate, and google scholar to identify studies related to chw initiatives and technology implementation previously conducted in lmics. the keywords used for the search were: chws, framework, technology, healthcare innovation ecosystem, social factors, technical factors, socio-technical systems approach in healthcare, and lmics. figure illustrates how the selected inclusion criteria were applied to identify the relevant articles. an iterative process facilitated the addition and removal of studies that were not explicitly addressed by the inclusion criteria. the data extraction process involved recording the full-text articles into publication year, region setting, study type, methodology and key findings after which the six elements were used to identify the relevant factors from the selected literature and categorize them under social or technical perspective [ ] . of the articles included for full-text analysis, most of them used qualitative and mixed methods inquiries involving interviews, focus group discussions with chws, healthcare systems stakeholders from government and non-governmental initiatives. the studies were conducted in lmics including south africa, uganda, ethiopia, kenya, mozambique, india, and zimbabwe. the type of publications resulted in articles on reviews, articles on empirical and on analysis studies. the conceptualization of an sts presented in [ ] was adapted and applied to the categorization in this study. the following discussion reflects on the analysis and synthesis deduced from the identified literature studies and used to categorize the relevant factors. a study by naimoli et al. [ ] posit that the health outcomes achieved through chws programs are a function of a robust, high performing health and community sectoral systems. the study further postulates that the programming activities categorized under social, technical and incentives support functions are influenced by a range of contextual factors in both community and health sectoral systems [ ] . however, the narrative presented in the previous studies alludes there is unbalanced attention on the impact of the complex and diverse context-specific nature within which chws work and live in [ ] . as a result, de neve et al. [ ] propose the need for countries to develop coherent and context-specific approaches to ensure optimal performance by chws through the consideration of the broader context, including demographic, socioeconomic, political, legislative, ecological, sociocultural, and technological factors contributing towards facilitating or inhibiting the success of many chws initiatives [ , ] . some of the solutions to achieve what is postulated in the studies include coordinating the health system and community system to prioritize factors that inhibit or facilitate the understanding of chws programs' compatibility with community structures, cultural values, and perception, socio-economic context and support system [ ] . in addition, integrating and adopting interventions supported by technological solutions, and the sustainability of these interventions should be considered when exploring efforts until the desired health outcomes are achieved to gain a better understanding of chws programs and their roles in lmics [ ] . previous research that was focused on chws and their performance placed emphasis on developing frameworks that provide a broad context of the chw's position in a larger environment by describing the interrelations of intrapersonal, family, community, and organizational settings as health professionals [ , ] . this perspective to a larger extent provides a limited understanding of the impact of the ecological environment on chws [ ] . most programs have not been able to effectively address the gap between research evidence and the routine practicality of chws as health professions, hence the poor integration of chws within the healthcare system and an even poorer understanding of their roles within their communities. subsequently, the implication of this postulates the need for a comprehensive approach to plan and design programs that can be integrated with the formal healthcare system's approach to healthcare service delivery through chws roles and organizations [ ] . moreover, the chw system requires an interface with the formal healthcare and the community systems involving the political structures, civic groups, faith-based organizations. schneider and lehmann [ ] argue that integrating chws into the primary healthcare systems while embedding and supporting them through the community is vital to realize their potential. contrarily, most studies emphasize the need for chws to be integrated within the formal healthcare system whilst placing minimal emphasis on understanding how they are embedded within the community system [ ] . moreover, minimal work has been done locally in terms of implementing universal guidelines to guide the integration strategies required to resolve the above-stated implications. previous research has proved that the effectiveness of chws holds the potential to increase access to equitable health in lmics [ ] . as a result, chws' understanding of the socio-cultural norms of their communities, their unique intermediary position between communities and the health system places them in a central setting in delivering key health interventions. on an individual level, their effectiveness is influenced by contextual factors, such as socio-cultural factors, gender, traditions and norms, training and supervision, health policies combined with intervention-related factors [ ] . furthermore, it is postulated in [ ] that support for chws has to be strategic, collaborative and well-coordinated to enhance chws performance between the two overlapping dynamic systems they are expected to function within. among the key challenges presented in the study, the definition and optimization of the impact of the chws' roles are highlighted as an influence on chw performance. also, [ ] argues that government and non-governmental institutions are continuously adding functions and tasks to chws, which buttresses the need to inform the type of tasks and position they hold within the healthcare system through competency-based or educational qualification rather than on functionalities. in most lmics such as south africa, the roles and responsibilities of chws with regards to technical and social capital is limited and yet to be understood [ ] . khalala et al. [ ] state that understanding the nature of the work chws do, enables researchers to explore the relevant technologies that can be exploited to facilitate and support their daily work. this understanding potentially provides information with regards to the choice of technology and how it can be implemented to support the roles of chws. regardless of the evidence on the social factors influencing chws, the exact mechanisms on how to assess the interdependencies of social and technical dynamics' influence on chws outcomes remains understudied. technologies are not neutral or passive objects but rather shape the environment and provoke social dynamics as a result of their existence and necessity for human survival. previous studies reveal that technologies have the potential to influence social, cultural and economic contexts and improve healthcare quality for communities when employed in the healthcare domain [ ] . expectedly, the use of mobile technology in south africa in the healthcare system has also increased, particularly among chws [ ] . despite chws having limited formal education and training, with poorly defined roles in using technologies within their line of work, it has been emphasized in [ ] that most research has focused on the usability and reliability of technologies with minimal emphasis on the users and the important aspect that they are social beings who interact with their immediate and remote communities. iluyemi et al. [ ] state that to conceptualize technological solutions and their policy interventions, it is important to start by gaining an understanding of the context of use and needs for the technology from the chws' perspective. in addition, the challenges of technology's usability and supportive structures. existing literature have focused on the reliability, functionality and infrastructure of the technology while paying minimal attention to the end-users perception on the usability and intentions to use the technology, as a result most of the research focus on the technical characteristics whilst neglecting the impact of the social characteristics of both the individual and community setting where the technology is utilized [ ] . nonetheless, this implies there is a need to conceptualize the appropriate technologies which can both fit the task they are used to as well as have the capabilities to perform the task. moreover, technology and policy interventions are deemed as necessary developments to enhance technological effectiveness and efficiency, and to ensure sustainability and scalability through the initiatives whilst amplifying their impact [ ] . thus, the technology acceptance dimensions are considered in describing the understanding of the technological capabilities of chws, their ability to access and utilize the appropriate technologies applicable to their social backgrounds. there is undeniable evidence from previous studies about the importance of considering the sociotechnical determinants in developing implementation and evaluation conceptual models for technological solutions. determinants including technological appropriateness and socio-cultural sensitivity, political infrastructures, the technology endusers' attributes and variables of ecological settings [ ] . in a formative study about the adoption and usage of mhealth by chws in india, kaphle et al. [ ] hypothesized that individual characteristics of end-users such as education, experience of care, and demographics hold the potential to influence the uptake of technological adoptions and quality of care. in addition, kim et al. [ ] reinforces that the attitude of health professions to use technology influences the behavioral intention to use it. as a result, the relationship between technology and chws' performance is associated with their readiness to align their behavioral intention to use the technology. important to note, technological solutions and processes are not autonomous vehicles, but rather are embedded within systems in a social world where they are used to perform activities which have consequences and influences changes on human behavior, social constructs, and cultural meanings. thus, the effect of this is that not only does the interaction between the technical and social systems exhibit complexity and unpredictable behavior; it inevitably increases the complexities of dynamic and autonomous relationships, which can be detrimental to the system in place. from the above sections, the following is presented in summary to illustrate the factors identified in the discussion using the sts hexagon for illustration as provided in [ ] . figure illustrates the social and technical perspectives identified from previous literature according to [ ] . from the discussion above, the factors (see fig. ) were categorized into concepts according to their similarities to allow for a reasonable number of concepts to be considered. the approach followed in this study desired that the design activities involve gaining understanding and specification of the context in which the system will be used by referring to the social factors, cultural factors, working practices factors, and the structure of the organization [ ] . thus, the terminologies for the concepts were adapted from this standpoint and were cautiously selected by the author through interpretation about the relevant literature as a means to preserve the relevance of the factors. the concepts were grouped under technical and social context depending on the interpretation of the author, from there, they were categorized under the two social dimensions: health and community systems context depending on whether the influence of the factor on the chws was related and reflective of the context in question. this study considers the following fundamental areas under the social system: the individual's needs, humans' social behaviors in work systems, internal and external environmental factors and support systems of the work system under investigation [ ] . whilst the technical system focuses on the processes, tasks, infrastructures, and technologies required and used in the work system to achieve the set goals [ ] . additionally, the technical dimensions included technology readiness which was concerned with categorizing the factors related to the technological solutions characteristics and compatibility to be used. the second dimension was technology acceptance and utilization which was concerned with factors concerning the chws perspectives and readiness to use and accept the technological solution within the environment they work. finally, the compatibility/fit element was considered as a means to provide the measures required to ensure a balanced joint optimization of both the technical and social aspects [ ] . figure illustrates the concepts classed under social and technical context. this research article aimed to articulate the key conceptual factors which should be considered when implementing technological solutions for chws within the south african context. the sts framework was used for the categorization of the factors which were integrated into concepts. for future work, each of these concepts will be evaluated and the categorization refined to present a broader conceptual framework. this study forms part of a dissertation project and the findings in this study form part of the first high-level conceptual framework which will be used in conducting scoping literature review to identify additional components for the secondary-level conceptual framework. in addition, future plans involve exploring the task-technology fit model to identify the relevant technological solutions fit for peri-urban and rural contexts in south africa. challenges of quality improvement in the healthcare of south africa post-apartheid: a critical review community health workers lensed through a south african backdrop of two peri-urban communities in kwazulu-natal who is a community health worker? -a systematic review of definitions use of mobile health (mhealth) technologies and interventions among community health workers globally: a scoping review perceived mhealth barriers and benefits for home-based hiv testing and counseling and other care: qualitative findings from health officials, community health workers, and persons living with hiv in south africa affecting factors on the performance of community health workers in iran's rural areas: a review article systematic review on what works, what does not work and why of implementation of mobile health (mhealth) projects in africa world bank country and lending groups -world bank data help desk using mobile technologies to support the training of community health workers in low-income and middle-income countries: mapping the evidence factors determining the success and failure of ehealth interventions: systematic review of the literature empowering community health workers with technology solutions best fit" framework synthesis: refining the method advancing sociotechnical systems thinking: a call for bravery adaptive socio-technical systems: a requirementsbased approach what encourages community health workers to use mobile technologies for health interventions? emerging lessons from rural rwanda strategic partnering to improve community health worker programming and performance: features of a community-health system integrated approach harmonizing community-based health worker programs for hiv: a narrative review and analytic framework factors associated with community health worker performance differ by task in a multitasked setting in rural zimbabwe which intervention design factors influence performance of community health workers in low-and middle-income countries? a systematic review adoption and usage of mhealth technology on quality and experience of care provided by frontline workers: observations from rural india from community health workers to community health systems: time to widen the horizon? community health workers in rural india: analysing the opportunities and challenges accredited social health activists (ashas) face in realising their multiple roles the roles and needs of community health workers in developing countries: an exploratory case study in south africa technology enabled health" -insights from twitter analytics with a socio-technical perspective adapting mhealth to workflow -a case study in south africa mobile information system, health work and community health workers in less developed countries scoping review assessing the evidence used to support the adoption of mobile health (mhealth) technologies for the education and training of community health workers (chws) in low-income and middle-income countries m-health adoption by healthcare professionals: a systematic review enablers and inhibitors: a review of the situation regarding mhealth adoption in low-and middle-income countries analysis of the factors influencing healthcare professionals' adoption of mobile electronic medical record (emr) using the unified theory of acceptance and use of technology (utaut) in a tertiary hospital socio-technical systems: from design methods to systems engineering key: cord- -qgqzr n authors: albrecht, harro title: global health. die gesundheit der welt in der internationalen politik date: - - journal: nan doi: . /s - - - sha: doc_id: cord_uid: qgqzr n with the adoption of the millenium development goals in , global health attracted notice to a worldwide public. this article analyzes the origins, the concept and the universal relevance of global health, discusses several international development programs (supported by the usa, the un, as well as and by private organizations) and examines their effects and their sustainability. während dieser sechs tage knüpfte george w. bush an seine am wenigsten gewürdigten außenpolitischen erfolge an. unbemerkt v.a. von der europäischen Öffentlichkeit hatte der us-präsident eines der umfangreichsten gesundheitsprogramme für entwicklungsländer angeschoben. schon hatte er den president's emergency plan for aids relief (pepfar) aus der taufe gehoben und zwei jahre später die president's malaria initiative (pmi). diese entscheidungen waren zwei erkenntnissen zu verdanken: erstens stellte die weltbank fest, dass gesundheitsprobleme in entwicklungsländern keineswegs nur lästige geldvernichter seien, sondern eine fundamentale ursache der armut. zweitens hatte die clinton-administration um die jahrtausendwende die weltweite aids-epidemie als mögliche gefährdung der inneren sicherheit der usa eingestuft. es ging um eine milliarde menschen weltweit, die bis heute keinen zugang zu einem gesundheitswesen haben, um , millionen kinder unter fünf jahren, die jedes jahr durch vermeidbare ursachen sterben, um zusammen fünf millionen menschen, die jedes jahr einer von nur drei krankheiten zum opfer fallen: aids, tuberkulose und malaria. mehr entwicklungshilfe im kampf gegen krankheiten und insbesondere aids, so die hoffnung der us-regierung, würde nicht nur den betroffenen helfen, sondern auch einen spürbaren wirtschaftlichen aufschwung in den ärmsten ländern nach sich ziehen und dadurch weltweit die sicherheitslage verbessern. diese außenpolitischen interessen decken sich mit den humanitären anstrengungen der weltgemeinschaft. unter diesem vorzeichen eröffnet sich die chance auf eine neue, nachhaltige verbesserung der gesundheitssituation der Ärmsten. zum ersten mal besteht die möglichkeit, dass die visionäre erklärung der weltgesundheitsorganisation (world heath organization, who) "gesundheit für alle" von alma ata aus dem jahr gestalt annimmt. doch wirken die außen-und sicherheitspolitischen motive maßgeblicher staaten darin nicht als störfaktoren? am anfang der neuen entwicklungshilfepläne stand ein diplomatisches problem, für das dringend eine lösung gefunden werden musste. john ruggie, zu diesem zeitpunkt persönlicher berater des un-generalsekretärs kofi annan, war mit einer heiklen mission betraut. die vereinten nationen steckten in den vorbereitungen für das gipfeltreffen zum millennium im september in new york. "die regierungen waren tief beunruhigt darüber, dass das treffen ähnlich inhaltsleer verlaufen würde wie das fünfzigste jubiläum der un-gründung", erinnert sich ruggie , der inzwischen politikwissenschaft an der harvard kennedy school of government lehrt. ohne ein vorzeigbares gemeinsames arbeitsziel hätten viele staaten ihre teilnahme abgesagt. also suchte annans berater mit seinen kollegen nach themen, die von möglichst allen staatsoberhäuptern akzeptiert werden würden. gesundheit und entwicklung erschienen unverdächtiger als sicherheitsfragen. die idee kam an, und so zielten schließlich drei von acht beschlossenen millennium-entwicklungszielen ( alle diese anstrengungen führen das wort global im namen. doch was genau ist global health? nach der definition des institute of medicine in washington, d.c. beschäftigt sich global health mit gesundheitsproblemen, welche die nationalen grenzen überschreiten, die lebensumstände und erfahrungen anderer staaten beeinflussen und die am besten durch kooperation gelöst werden können. in global health trifft also definitionsgemäß gesundheit auf außenpolitik. erdacht werden die global health-konzepte vor allem an us-universitäten wie harvard und columbia und dort vor allem an den schools of public health. für diese art von "schulen" existierte bislang im deutschen sprachraum keine entsprechung. das ist insbesondere deshalb erstaunlich, weil die public health-idee sich aus Überlegungen des deutschen arztes und politikers rudolf virchow aus dem . jahrhundert ableitet (goschler (marmot/ wilkinson ) . weil public health dabei nicht nur die pathologie spezifischer erkrankungen, sondern auch die lebensbedingungen des menschen einbezieht, berührt das fachgebiet unter anderem auch fragen der wirtschaft, psychologie, politik und kultur -oder wie rudolf virchow es ausdrückte: "die medicin ist eine sociale wissenschaft, und die politik ist nichts weiter als medicin im großen." global health als ausdehnung von public health im weltweiten maßstab ist eines der umfassendsten wissenschaftsgebiete. es beschäftigt sich mit problemen der lebensumwelt, des handels, des wirtschaftswachstums, der sozialen entwicklung, der nationalen sicherheit und der menschenrechte. weil in entwicklungsländern das geld für staatlich finanzierte individuelle therapien fehlt, ist public health hier die vorherrschende medizinische ausrichtung. dies bedeutet, dass krankheitsprävention priorität vor der behandlung von krankheiten genießt, und wenn therapiert werden muss, dann möglichst nur solche erkrankungen, bei denen mit minimalem einsatz die größte wirkung für die meisten menschen erzielt werden können. viele schwere erkrankungen, etwa fortgeschrittene krebserkrankungen, werden also nicht mit hilfe öffentlicher mittel therapiert. wer eine individuelle gesundheitsleistung dringend benötigt, muss sie in entwicklungsländern selbst bezahlen, und so verwundert es nicht, dass in diesen ländern über achtzig prozent der gesundheitskosten von den kranken übernommen werden. weil global health vor allem public health-methoden anwendet, sind die zielgebiete dieser disziplin die entwicklungsländer. die einseitige ausrichtung des blickes der wohlhabenden staaten auf die ärmeren länder aber erscheint in zeiten der globalisierung wenig sinnvoll. heute liegt es näher, das wort global wörtlich zu nehmen und keine unterschiede zwischen nord und süd, reich und arm zu machen. durch das rapide bevölkerungswachstum, den abbau der handelsschranken und den internationalen massenverkehr ist zum ersten mal in der geschichte der menschheit die gesundheit jedes einzelnen relevant für die gesundheit aller anderen. die klimaerwärmung, v.a. von den industrieländern verursacht, verändert die lebensbedingungen weltweit. die radioaktiven substanzen des explodierten kernreaktors in tschernobyl hatten noch tausende kilometer entfernt auswirkungen auf die gesundheit der menschen. wenn in einem deutschen krankenhaus eine krankenschwester aus malawi oder den philippinen arbeitet, dann fehlt sie in ihrem heimatland. infektionskrankheiten wie influenza oder sars sind unter umständen nur einige flugstunden von einer der megastädte der welt entfernt. umgekehrt übernehmen jene menschen in den entwicklungsländern, die über ein wenig wohlstand verfügen, den westlichen lebensstil mit Überernährung und bewegungsmangel. inzwischen hat die zahl der herzinfarkte und diabetesfälle auch in tropischen breitengraden extrem zugenommen (kawachi/wamala ) . die idee von global health wörtlich zu nehmen hieße aber auch, dass jedes land verantwortung für die gesundheitsprobleme in einem anderem übernehmen muss. genauso wie im zusammenhang mit der Öffnung der weltmärkte und der globalisierung über notwendige neue soziale standards diskutiert wird, braucht auch die weltgesundheit ethische rahmenbedingungen. es darf nicht sein, dass entwicklungen in einem staat auf kosten der bevölkerung eines anderen gehen. ansätze dieses verantwortungsprinzips sind in den internationalen gesundheitsvorschriften der weltgesundheitsorganisation verankert. sie geben der who das recht, im fall von epidemien untersuchungen in einem land durchzuführen und reisewarnungen auszusprechen. viele fragen bleiben bisher jedoch unberücksichtigt -etwa jene, ob etwas unternommen werden soll, wenn medizinisches personal aus einem entwicklungsland durch bessere bezahlung in reiche länder gelockt wird. gleichzeitig eröffnet die globalisierung aber auch chancen, die gesundheit im globalen maßstab zu verbessern. inzwischen haben schwellenländer wie brasilien und indien mit der produktion günstiger medikamente begonnen und beispielsweise die therapie von tuberkulose auch in den ärmsten ländern ermöglicht. die Überwachung von epidemien und die frühwarnung vor naturkatastrophen und hungersnöten über die moderne telekommunikation und internet sind heute besser denn je entwickelt. erfahrungen aus vielen tausend gesundheitsprojekten liegen vor, die wege aufzeigen, wie menschen mit wenig geld geholfen werden kann. allein die orale rehydrationstherapie (ort) mit einer einfachen zucker-salz-lösung rettete millionen durchfallerkrankter kinder das leben (banerjee ; levine ) . daneben sind aufgrund der zunahme chronischer erkrankungen public health-konzepte auch in entwickelten ländern mehr denn je gefragt. global health aber kennt im augenblick vor allem eine blickrichtung: die aus dem reichen norden in den armen süden. der begriff ist zum synonym geworden für gesundheitsbezogene entwicklungshilfe vor allem durch die usa (kickbusch ) . zwar geben die usa mit , prozent des bruttoinlandsprodukts vergleichsweise wenig für die entwicklungshilfe aus. in absoluten zahlen aber überragt diese summe zusammen mit dem gewaltigen privaten spendenaufkommen z.b. von microsoft-gründer bill gates und dem investor warren buffet die entwicklungshilfeausgaben aller anderen länder. die amerikanische agenda folgt einem geist, den der brite alex de waal, direktor des social science research council in new york city, als das ergebnis einer "erlösungs-agenda" beschrieb, "der Überzeugung, dass eine kombination aus geld, technologie und gutem willen jedes problem lösen kann. religiöse gruppen fügen noch den ‚glauben' hinzu" (de waal : ) . so ist die bill & melinda gates-stiftung für ihre suche nach technischen lösungen, etwa neuen impfstoffen, und für ihre zielorientiertheit bekannt. genauso strebt die us-regierung schnell erreichbare ergebnisse an, die der wählerschaft präsentiert werden können. eine umfassende strategie zur langfristigen verbesserung der lebensverhältnisse, wie sie rudolf virchow vorschwebte und wie sie auch an vielen amerikanischen schools of public health gelehrt wird, passt allerdings nicht zu den vorstellungen amerikanischer politik. in den usa ist alles, was im entferntesten nach sozialismus aussieht, verpönt. public health aber ist vom grundgedanken her sozialistisch, weil sie die fürsorgepflicht des staates für die gesundheit der bürger fordert. so glänzen sozialistische staaten wie kuba, der indische bundesstaat kerala oder früher russland bei geringem mitteleinsatz oft mit bemerkenswerten gesundheitsdaten. die durchschnittliche lebenserwartung in kerala beträgt jahre bei einem pro-kopf-jahreseinkommen von rund us-dollar. auf welche weise ideologie und außen-und innenpolitische agenden die neuen großprogramme prägen, zeigt eindrücklich das beispiel von uganda, das im zentrum der neuen global health-bewegung steht. schon kurz nach der machtübernahme klärte ugandas neuer präsident yoweri museveni als einer der wenigen afrikanischen staatsoberhäupter die bevölkerung schonungslos über die neue immunschwächekrankheit aids auf ( de waal ; green ) . museveni war dabei nicht in erster linie von der sorge um die gesundheit der massen getrieben, sondern von jener um die potentielle schwächung seiner streitkräfte. nach der rebellion hatte der sozialist sechzig offiziere zum training nach kuba fliegen lassen. dort waren zu dieser zeit hiv-tests obligatorisch. als der noch ahnungslose ugandische präsident wenig später auf einer konferenz in simbabwe erschien, nahm ihn fidel castro zur seite und warnte seinen bundesgenossen: "du weißt, dass du ein großes problem in deinem land hast?" es hatte sich in kuba herausgestellt, dass achtzehn der getesteten soldaten das tödliche virus in sich trugen. die antiretrovirale therapie war noch nicht weit entwickelt und ohne geld in der staatskasse blieb museveni nichts anderes übrig, als seine landsleute in radiospots, mit plakaten, kundgebungen und theatershows zur enthaltsamkeit und ehelicher treue anzuhalten. das konzept ging offenbar auf, denn in den folgenden jahren sank die aids-rate deutlich. diese erfolgsgeschichte war der anfang des wandels der erkrankung aids zum politikum aids. deshalb ist uganda heute der größte nutznießer des neuen engagements der internationalen gemeinschaft in sachen aids. allein im jahr flossen vom global fund, von weltbank und pepfar millionen us-dollar in die staatskasse ugandas. dies ist mehr als das gesamte gesundheitsbudget für alle anderen krankheiten zusammen genommen. der ununterbrochene strom an aids-gebundenen zuwendungen versetzt den präsidenten in die lage, seinen landsleuten immer neue programme offerieren zu können. mitsprache und demokratische prozesse entwickeln sich unter diesen bedingungen nur zögerlich, und nun steht yoweri museveni im zweiundzwanzigsten jahr seiner alleinherrschaft. man könnte sagen, die aids-hilfsgelder haben diese un-demokratische regierung erst stabilisiert. dass es auch anders geht, zeigt das konzept des global fund. dieser gibt seine gelder zwar direkt an die regierungen und überlässt ihnen die verteilung. in uganda zog er jedoch nach gravierenden fällen von korruption weitere geldzusagen zurück -eine aufsehen erregende maßnahme, die noch heute von ugandas zeitungen intensiv diskutiert wird und die zeigt, wie eine schärfere kontrolle bei der vergabe von hilfsgeldern auch demokratische debatten begünstigen kann. die pepfar-uganda-liason begann mit einem treffen zweier sehr ungleicher männer in einem flugzeug: edward green, medizin-anthropologe aus harvard, und richard holbrooke, ehemaliger us-botschafter bei den vereinten nationen. holbrooke hatte sich schon lange für den kampf gegen aids eingesetzt, weil er die infektionskrankheit für eine größere bedrohung der nationalen sicherheit hielt als etwa die verbreitung von nuklearwaffen und die explosive lage im nahen und mittleren osten. anfang des jahres übernahmen die usa den vorsitz des sicherheitsrates der vereinten nationen, und holbrooke nutzte die chance, um aids auf die agenda zu bringen. zum ersten mal in der geschichte des un-sicherheitsrates war gesundheit der gegenstand der debatte. im folgenden jahr schied holbrooke aus den vereinten nationen aus und setzte sich vehement bei kofi annan und george w. bush für einen aids-fond im umfang von zehn milliarden us-dollar ein. es sollte noch zwei jahre dauern, bis holbrookes vorstellungen sogar übertroffen wurden. gab george w. bush den president's emergency plan for aids relief aus: milliarden us-dollar, auf fünfzehn länder verteilt für einen zeitraum von fünf jahren. ende des jahres flogen green und holbrooke zusammen mit einer -köpfigen delegation auf eine aids-informationstour in vier afrikanische länder. green war begeistert und inspiriert von den anfänglichen erfolgen der treue-kampagne musevenis. im gepäck trug der harvard-professor deshalb ein exemplar seines damals frisch veröffentlichten buches "rethinking aids prevention" (green ) . darin legt green dar, dass er die reduktion der anzahl der sexualpartner für die schärfste waffe im kampf gegen aids halte -wobei er den einsatz von kondomen nicht ausschließe. holbrooke "hat in den ersten tagen mein buch gelesen und war davon sehr angetan. er hat gesagt: das ist wirklich gut", erinnert sich green. aber auch der us-gesundheitsminister tommy thompson hatte im flugzeug gesessen und den medizin-anthropologen nach der reise zum gespräch einbestellt. auf diese weise wurde green zum berater der konservativen us-regierung und uganda einer der hauptempfänger des geldsegens. das daraus resultierende programm war jedoch höchst umstritten. ein drittel des pepfar-geldes sollte zur verfügung stehen für kampagnen zur enthaltsamkeit und treue unter dem motto "abstinence, be faithful and condoms" (abc) -wobei kondome nur unter risikogruppen wie prostituierten und drogensüchtigen propagiert werden durften. die liberale aids-szene in den usa hielt die an christlichen werten orientierte abc-kampagne für eine katastrophale abkehr von der in den usa bewährten strategie des "safer sex und kondome für alle". außerdem bemängelten kritiker, dass pepfar-projekte vollständig parallel zum restlichen gesundheitssystem implementiert würden. sie verfügten über die besseren laborausstattungen, über autos und einen konstanten strom an medikamenten, und sie zahlten dem personal höhere gehälter. dadurch sei das programm zwar effektiv, aber belaste die ressourcen des restlichen gesundheitssystems und sei somit nicht nachhaltig. eine bessere alternative sei das finanzierungsmodell des global fund gewesen, statt das gros der mittel in die us-anstrengung pepfar zu investieren. sicherheitspolitische bedenken des größten entwicklungshilfefinanziers hatten aids auf die internationale agenda gebracht, und die vorstellungen der usa hatten die ausführung der programme geprägt. die konzepte funktionieren im kern noch immer nach dem prinzip der helfenden hand in zeiten des krieges, bei Überflutungen, dürrekatastrophen oder epidemien. dieses herkömmliche, karitative motiv aber verfolgt nicht die langfristige konsolidierung maroder gesundheitssysteme. "wir leben angetrieben durch den gates-buffet-effekt in glücklichen zeiten der globalen public health", schrieb susan erikson ( ) , "doch es gibt ein paar gesundheitsziele, die man nicht mit geld wird kaufen können, weil einflussreiche staaten aktiv eine außenpolitik verfolgen, die diesen zielen diametral entgegengesetzt ist." dazu zählen handelsabkommen, die die ernährungssicherheit bedrohen, lockangebote für medizinisches personal armer länder und multinationale unternehmen, die erfolgreich ihre patente für essenzielle medikamente verteidigen. "wenn andere interessen wie die nationale sicherheit als bedroht angesehen werden, ist gesundheit von zweitrangiger bedeutung", schreibt erikson. (masanja et al. ) . das moratorium zeitigte schon bald einen erfolg: gerade haben wissenschaftliche studien belegt, dass das ostafrikanische land auf gutem wege ist, das millenniumsziel der verminderung der kindersterblichkeit zu erreichen. csis commission on smart power. a smarter, more secure america health is global. proposals for a uk government-wide strategy getting political. fighting for global health rudolf virchow. mediziner -anthropologe -politiker. köln rethinking aids prevention. learning from successes in developing countries globalization and health influence and opportunity. reflections on the u.s. role in global public health case studies in global health. millions saved social determinants of health oslo ministerial declaration -global health. a pressing foreign policy issue of our time aids and power. why there is no political crisis -yet key: cord- -yeavs o authors: guidotti, tee l. title: occupational medicine: an asset in time of crisis date: - - journal: disaster medicine doi: . /b - - - - . - sha: doc_id: cord_uid: yeavs o nan c h a p t e r occupational medicine: an asset in time of crisis corporations and other large institutions have become deeply concerned with continuity of operations and the security of their personnel. the new urgency placed on these functions since sept. , , has drawn attention to a substantial resource already in place in such organizations-their occupational health services. the imperatives of corporate security and homeland defense have, in turn, invigorated and expanded the mission of occupational medicine, one of the oldest recognized medical specialties. occupational health services are most familiar in the manufacturing sector and in the setting of a plant's medical clinic. typically, such services include at least one occupational health nurse (also a professional specialization); an occupational physician (typically on contract); and support staff, all of whom report on a regular basis to a plant manager and are responsible professionally to a corporate medical director, who himself or herself serves as a traveling troubleshooter, in-house resource on health issues, and auditor for health affairs. this physician-led, health-centered team typically is engaged in regular interaction and troubleshooting in collaboration with an industrial hygienist and safety officer, who are usually oriented more toward process and plant operations, documenting regulatory compliance, and identifying and measuring health hazards. these hazardoriented professionals usually report to a different manager or directly to the plant manager. this basic pattern was once the norm in industry, but the dramatic reorganization in industry, management focus on core business, and the rise of the service sector have forged a new pattern, in which services are outsourced to contractors and consultants. however, whichever pattern is followed in a particular enterprise, the following essentials are in place in most large operations: a means of monitoring the health of workers, a system for documenting their health, a system for documenting and evaluating hazards, a mechanism for responding to emergencies, and a panel of health consultants. this is exactly the type of infrastructure that large organizations need so that they can respond to disasters and protect the security and continuity of operations. thus, large organizations already have in place a structure on which to build to protect their operations and personnel. involvement of the occupational health service in emergency management, which was common in the past, is a natural extension into disaster medicine, involving training and preparation for consequence management and mitigation activities, preparedness for a response indigenous to the physical plant, and planning for the management of risks inherent to the operation. , the occupational health service also has an important place at the table as an active member of the healthcare team, interacting with local prehospital care providers and hospitals on the local emergency preparedness committee (lepc). box - presents the usual functions of a corporate medical department, provided or supervised by occupational physicians. these functions have traditionally been clustered in a few broad missions: to protect health, to support productivity, to reduce loss and liability, to manage health affairs, and to ensure compliance with regulations and best practice for the industry. these functions have traditionally been viewed as support functions, not part of the business operations of the organization. indeed, this is why these functions were subject to outsourcing throughout the private and government sectors during the s and s. a new realization of the criticality of these functions is spreading in the corporate sector, stirred by the awareness of the profound threat of major industrial incidents and potential terrorist attacks to the continuity of operations and the survival of key personnel. , the role of the occupational physician is increasingly recognized for its potential to contribute to the survival of the enterprise, not just its efficient operation. for example, dow received an award from the state of michigan public health department for assistance to the state, particularly with respect to its efforts in disaster planning. the usefulness of a trained, well-informed, prequalified medical resource for dealing with incidents on-site is obvious. these incidents may include, but are certainly not limited to, sending infectious material through the mail to company personnel and using company equipment, such as airplanes or, potentially, chemical plants or storage facilities, as instruments of assault. the occupational physician, who is trained in hazard assessment, also may assume the responsibility of determining when a site is safe to re-enter or when a facility can be reopened. he or she also would be responsible for managing the psychological consequences of an assault. less obvious, but equally valuable, is the role that such physicians may play in managing the consequences of widespread disruption to business operations due to major threats and in protecting the business, the product, and the brand against catastrophe in cases in which a company's products, facilities, or operations are used to deliver a threat or become targets for terrorist activity. in time of crisis, the occupational physician may help get the community back on its feet by helping to keep an employer open or critical infrastructure functioning. similarly, the occupational physician has been called on to manage the corporate response to serious health-related issues, such as traveling to areas in which severe acute respiratory syndrome (sars) and other emerging infections are a risk; rapidly investigating suspicious outbreaks of disease or exposure to potential hazards; and determining when re-entry and reoccupancy is possible in contaminated facilities, such as post office facilities contaminated with anthrax. several companies, including cathay pacific, participated in an informal monitoring network during the sars epidemic to share observed trends and experience when the information they needed was not forthcoming from conventional sources. procter and gamble, alerted to the emerging problem by its own corporate medical leader for china, instituted sars precautions a month before any official warnings were advised. these functions build on the traditional involvement of physicians in disaster planning, as well as health protection for employees. , disaster planning has traditionally been one of the core functions of the medical department and occupational physicians in corporate settings. the physician has usually assumed responsibility within the organization for planning the medical response to emergencies, identifying facilities and resources for dealing with serious injuries and mass casualties, and providing health protection for key personnel, if required. although outsourcing has reduced the direct involvement of occupational physicians in planning emergency management in many organizations, particularly in the service sector, this function has not been completely replaced by external consultants because it requires a practitioner with intimate knowledge of the operations, hazards, workforce, and policies of the organization. the occupational physician can add value to the management of catastrophic consequences in many other ways. these include the following: • survival of key personnel in a catastrophic event • continuity of business after a catastrophic event • instant connectivity to resources for assistance in a health-related emergency • surveillance of the workforce and the early detection of an outbreak • integration of emergency response with public health agencies • surge capacity in the event of a local event that requires mobilization of all available medical resources • vaccination programs and other protective measures • establishing on-site consequence management and mitigation programs • developing decontamination plans • providing specialized, sector-specific expertise to emergency managers • advising on effective personal protective equipment (ppe) • liasing with the lepc, prehospital care, and hospitals • continuing education and training on-site and in the community of the indigenous risks inherent to the operation • accessing material safety data sheet information • leading any after-action discussion to bring about process and system improvement • fitness-to-work evaluations that assess the recovery and functional capacity of injured employees to return to work and what accommodations may be needed • impairment evaluation for injured workers who are the subject of workers' compensation claims • certification of time off work for workers with a nonoccupational illness or injury (this is often performed by other physicians) . review of workers' compensation claims for causation . periodic health surveillance of employees exposed to a particular hazard, such as noise, chemicals, dusts, or radiation (this often takes the form of a medical examination, often conducted annually) . investigation of exceptional hazards, disease outbreaks, unusual injuries, fatalities, or other emerging issues . prevention, health promotion, and educational programs designed to enhance the health of employees and to increase productivity . management of the health problems of employees on-site to reduce absence and disability . advice and consultation to management on issues of health, health and workers' compensation insurance, and regulatory issues in occupational health . disaster planning and emergency management on-site . external communications on health issues (e.g., with local public health agencies and local physicians) . managing relations between the organization and local hospitals and the medical community . employee assistance programs for employees with problems involving alcohol and drug abuse or other addictive behaviors, such as gambling, that interfere with work . executive wellness programs, such as special medical evaluations or monitoring health problems among senior executives larger and more complex organizations may also involve the occupational physician in managing environmental risks, product safety, contracting for health services, representing the organization in industry-wide health activities, and proactive programs for preparedness, risk management, and other senior management functions. performing these duties effectively requires committed time for preparedness activities and an occupational health service that is structured and whose providers are trained to play such a role in time of crisis. however, it is costly and inefficient for even large corporations to dedicate a full staff and support structure for the management of an event that may or may not materialize. this is why adaptation of the existing occupational health service makes sense for many employers, especially those in critical or hazardous industries. incorporating emergency management into the mission of the occupational health service builds allows for an emergency response system that a business would not otherwise have. the same resources used for tracking employees' health can be used for surveillance to detect potential disease outbreaks due to bioterrorism. the technology of hazard identification and measurement can be applied to detect chemical or radiation threats. the medical staff on duty primarily to monitor health and to provide timely clinical care can provide surge capacity in time of crisis. health protection for senior executives, and the personal knowledge that this entails, can keep key personnel on the job and safe, especially when they are moved to new locations or are operating under conditions of stress and potential risk. the skills that are normally applied to ensuring a safe workplace can be used to determine when it is acceptable to return to work or to venture into a facility that has been contaminated or damaged. planning for foreseeable industrial disasters can inform and refine the response to unforeseen threats, given that sophisticated disaster planning is a matter of identifying resources and contingencies, not deriving detailed plans for single-threat incidents. perhaps most attractive to cost-conscious managers is that investment in expanding the emergency management capacity within an occupational health service is not "lost" if an event never occurs. the same capacity supports and enhances the traditional occupational health services that industry and government employees require and may lead to cost savings, increased productivity, and reduced liability in their own right. occupational physicians, who are conscious of their responsibility and aware of their own position on the firing line along with the employees and executives they protect, have been preparing themselves for an expanded role in emergency management. the principal specialty organization, the american college of occupational and environmental medicine (acoem), has for some time offered training in the characteristics of weapons of mass destruction (well before sept. , , and the anthrax assaults), emerging infections (particularly using the model of sars), and "tabletop" exercises to train participants in emergency management and consequence management for disasters and mass casualties. immediately after the sept. , , tragedy, an acoem task force produced a guide to the management of mental health issues among survivors of mass assaults, disseminated it to all members, and posted it on the acoem web site-all within four days. this achievement was unique and widely admired among medical specialty organizations. in , leaders within aceoem developed the occupational health coordinating group (oh-cg) as a resource for coordinating responses, accessing management resources, and sharing information in times of crisis. it includes physicians, occupational health nurses, industrial hygienists, and other occupational health professionals. the oh-cg is a working council, sponsored by the department of health and human services, within what will eventually become a health-sector isac (informational sharing and coordination) organization. this is a highly unusual and encouraging development in many respects. isacs have official status with the department of homeland security and are intended to coordinate the planning response of critical sectors of the american economy and society. they have been formed, for example, in industry sectors such as critical utilities and transportation. the oh-cg was the first health-sector isac to be created and is now the occupational health subcommittee of the healthcare sector coordinating council, the isac for healthcare. this is a remarkable achievement for a relatively small medical specialty. because occupational health is crosscutting across industries, the oh-cg is expected to serve as a resource for other critical sectors rather than to focus primarily on the health sector per se and in so doing uniquely relate to other isacs as much as the one of which it is a part. its mission is to provide occupational health professionals with what they need and when they need it in a time of crisis through channels that do not depend on any one mode of communication. how might an organization prepare its occupational health department to respond on this scale in a crisis? partly, the answer is to build an effective and efficient team. teamwork comes from training and planning but also from regular personal contact and cooperation. a team that functions well in the complex duties of an occupational health service and that already knows the operations, workforce, and facilities is more likely to function well in an emergency than would an outside provider, who may not be around during a crisis. another part of the answer is to build redundant information and communication systems that can quickly retrieve critical information on hazards, disease or injury patterns, and individual health records in an adverse environment. occupational health systems may require upgrading to do this effectively, but the technology is readily available. partnerships within the lepc, local industry, and other like facilities not only reduce the initial and ongoing costs but also enable more efficient planning, training, and response. acquiring the necessary expertise is obvious. the occupational health staff may require special training to take on the additional functions, but this is not much of a stretch from current duties. county emergency managers are eager to share training opportunities through grants and other programs within the public domain. on-site training and response in coordination with local prehospital care using strategies of consequence management and mitigation, education, decontamination, and ppe will support occupational safety and health administration efforts to protect workers and may reduce liability exposure for the organization's insurers. the expense for pre-paredness may be justified by potential reductions in insurance premiums, as well as reduction of loss in the event of an emergency. establishing networks and agreements for mutual assistance may be critical. here, the occupational health staff can coordinate arrangements with local hospitals, specialist practitioners, public health agencies, and first responders in advance and maintain personal relationships required for smooth operation in the event of a crisis. the first step is to forge an active participant's role in the lepc. some counties have a more active, dynamic, and responsive lepc than others do. an occupational health service for a large organization has the opportunity to lead and become the backbone of emergency management in the community. facilities planning may be required, taking into account the characteristics of the site for evacuation, securing the premises but preserving access for ambulances and first responders, and defining areas of the plant for operational response (e.g., for staging rescue operations, triage, stabilizing casualties, decontamination, and "incident command" activities). even locations without special hazards may benefit from such contingency planning in the event of an external threat. for example, the first anthrax assault was in the office of a newspaper, not normally a high-risk location. under various contingencies, surge capacity may be projected, as well as whether to call in help for managing mass casualties on-site (especially if local hospitals are not functioning or cannot be reached), to assist other units in a mutual assistance pact, or to perform services such as mass immunizations. on-site decontamination may have to be continued at the hospital or a second location away from the industrial incident. surge capacity operations may be created away from the hospital under the direction of the lepc, county emergency manager, or hospital. this may include separate healthcare mutual aid agreements specific for the incident and secondary triage and treatment provided by trained physicians and other healthcare providers through the use of vendor agreements or prepositioned equipment and supplies. this strategy will enable the hospital and community healthcare delivery system to operate at near-standard operations during an industrial incident. any facility that has potable water, electricity, and shelter may participate. pre-existing arrangements for accessing these sites should be spelled out under mutual aid agreements, vendor contracts, memoranda of understanding, or special circumstances agreements negotiated in advance between the county emergency management office, the hospital, or the local employer. documentation of expenditures is a critical function, just as it is in the incident command structure, to reimburse all nonvolunteers and contracts executed in the response. certain routine functions can be anticipated and planned. for example, if anthrax or some other threat is determined to be a possibility for a business, procedures can be put in place in advance to protect employees, limit disruption, and rapidly evaluate evolving situations. this was done in a timely manner by dst output, the nation's largest direct mail operation, on the advice of its medical director. planning is particularly important to deter inevitable hoaxes and to prevent disruptions to business from ill-defined or unknown hazards. for example, the common scenario of an unknown "white powder" appearing on a loading dock or in an office can shut down operations for a day or more until a toxic substance is ruled out. having the capacity on hand to show that it is harmless saves time and anxiety. confronted with a true emergency, most people behave in an adaptive, rational manner that helps them to get through the crisis and to mitigate personal damage or injury. some are capable of helping others in an emergency. this response appears to be shaped, at least in part, by whether the emergency arises from a natural disaster or a "technological" event (an incident arising from human agency). the perception of an intentional assault may also shape the psychological response for some people. some people in situations of perceived catastrophic risk behave irrationally, however, and demonstrate psychogenic symptoms and maladaptive behavior. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] dealing with anxiety-promoting perceptions and psychogenic symptoms among employees that arise from rumors or incidental illness occurring at the worksite requires skill in rapid assessment and in risk communication but can save an enterprise from devastating loss of confidence and potential loss from employees who may refuse to come to work. distinguishing between human drama and a true emergency arising from a nonobvious cause is also a challenge that requires specialized expertise that is within the scope of the occupational physician. an enterprise may be in a position to control its liability and potential loss from claims after a disaster by developing a flexible, effective emergency management capability within its occupational health services before a disaster event. in addition to reducing actual loss through planning and effective consequence management, which is most important, such an enterprise would also be able to show after the fact that it had done its due diligence in anticipating and preparing for plausible threats. this could reduce its exposure to punitive awards or claims based on negligence or omission. legal opinions on this may vary, but it seems reasonable that a company that appears to be prepared is less likely to be accused after the fact of ignoring a foreseeable threat. in the classic business model followed during times of business as usual, the priorities of corporate management in descending order are shareholder value and profitability, continuity of production and operations, and loss control and risk management. for government agencies, there is a similar set of priorities, with the mission of the agency coming first. however, in times of crisis, survival of the enterprise and protection of people take precedence. in the past, occupational medicine and occupational health services have always been perceived as support functions, facilitating management priorities, but not core business priorities. in the new era of threats to survival and business continuity, occupational health services and the physicians in them may play a role in the survival of the enterprise and its people. a wise organization, faced with an extraordinary threat, may look within to build its salvation on a functioning system that already serves its interests. what is the strategic value of occupational and environmental medicine? observations from the united states and australia role of the occupational and environmental medicine physician terrorism: biological, chemical, and nuclear introduction to emergency management managing incidents involving hazardous substances terrorism: biological, chemical, and nuclear public health management of disasters: the practice guide municipal and emergency health care planning in disasters common misconceptions about disasters: panic, the "disaster syndrome epidemiologic features that may distinguish between building-associated illness outbreaks due to chemical exposure or psychogenic origin mass hysteria in an arab culture protean nature of mass sociogenic illness: from possessed nuns to chemical and biological terrorism fears occupational mass psychogenic illness. history, prevention and management dissociative reactions to the san francisco bay area earthquake of an investigation of apparent mass psychogenic illness in an electronics plant investigation of factors affecting mass psychogenic illness in employees in a fish-packing plant why people "freeze" in an emergency: temporal and cognitive constraints on survival responses industrial mass psychogenic illness: the unfashionable diagnosis disaster psychiatry: principles and practice dysfunctional buildings or dysfunctional people: an examination of the sick building syndrome and allied disorders an epidemic of respiratory complaints exacerbated by mass psychogenic illness in a military recruit population key: cord- - ufwlw authors: nan title: covid- and social distancing date: - - journal: can j addict doi: . /cxa. sha: doc_id: cord_uid: ufwlw nan these days, drafting an editorial which will be of relevance months hence is a daunting task. a planning meeting with our editorial team and publisher inspired us to chronicle our current pandemic anticipating with some trepidation to compare the accuracy of our perceptions with the realities in june. this vision may also be an important archive for future similar events. on april th, the recorded global number of cases was . million with , deaths ( . %), the united states cases were , with , deaths ( %) and canada was at , cases and deaths ( . %). on march st, canada had no recorded deaths. we also learned that these numbers very much depended on the extent of population screening performed. in north america, the "apex" of the epidemic curve is still nowhere in sight but people draw solace from the fact that drastic public health measures in china and south korea appear to have abated the escalation of number of cases and eventually signifi cantly reduced the incidence of new ones. social distancing in a compliant population has been credited for controlling the epidemic. drones were even used to monitor behaviour. that experience was contrasted with rapidly escalating european statistics overwhelming the health care system and resulting in a higher rate of mortality, including among health care providers. the diff erence again was attributed to a culturally freer society with a higher rate of interconnectedness and perhaps diff erences in vulnerable age groups. spurred by these experiences, canada, like other countries, adopted social distancing as its most visible public health measure. travelling back from the united states, i completed a day period of isolation which i am sure contributed to my choice of topic. socialisolation as a public health measure highlighted some unintended challenges for our addiction services. this pandemic demonstrated once more that an essential target of our practices is to rebuild our patients' positive social connectedness with peer groups, families, worksites, and communities in general. our detailed assessments aim to establish a rapport with our patients along with motivational interviews to encourage initiation and compliance with treatment programs. these programs largely provide a mix of individual, group, and family activities where interactive professional and peer support is promoted. the frequency of the administration of medication in harm reduction programs aim to encourage regular treatment contact in addition to monitoring. residential programs emphasize group identifi cation and mutual help fellowship is a pillar of the maintenance of recovery. it is fully realized that measures to control a lethal viral pandemic aim to keep people alive. in most cases, the epidemic will hopefully resolve in a matter of months and distancing is temporary. gratitude is due to our colleagues and other fi rst responders who risk their lives by willingly exposing themselves and their loved ones to potentially lethal infection in our midst. can we however learn from this fresh experience to refi ne our strategies? as a consumer of north american media, a recipient of a fl ood of daily emails and listening to experts (ccsa, who), i cannot help but draw the following perceptions: ( ) public health preparedness-pandemics are a recurrent phenomenon. in the last years, the world has experienced sars, h n , ebola, zika, mers, and now covid- . they are salient by their lethality but also occur on top of other more endemic epidemics, such as viral hepatitis, hiv, or west nile encephalitis among others. this frequent occurrence should dictate education and training in disaster strategies in our curricula. we may have short memories, but we were caught fl at footed with very limited inventories in screening tests, pipettes, and protective gear all the way up to icu beds and ventilators. social distancing to ensure new cases did not overwhelm limited inventories became the major dilemma. covid chronicles volume no. www.canadianjournalofaddiction.org editorial ( ) isolation and testing-every pandemic has its own characteristics and predictions can be diffi cult at the onset. in a few short weeks, we experienced a number of changes in the criteria for entering or leaving isolation, but the relative absence of screening tests and results awaiting to days led to a loss of valuable healthcare resources. uniformly isolating for weeks, people, many untested, led to the loss of valuable workforce. the risks associated with asymptomatic contacts remain a mystery, as we have so far no reliable prevalence data. ( ) recognition of addiction and mental health issues as part of an infectious disease pandemic -perhaps as an indication of stigma reduction, addiction, and mental health challenges are receiving better scrutiny. social distancing is required but social isolation should be prevented. of note, the concept of social distancing evolved into physical distancing. are countless webinars enough? local epicentres of the disease occurred in nursing homes, shelters, prisons, and the homeless all sharing degrees of isolation. the reaction to the pandemic has been compared to a mass grief reaction, with phases starting with denial, followed by anger, bargaining, and fi nally acceptance. ( ) technology as an alternative to personal contact-predictably, we have been reminded how electronic communication could supplement or replace face to face contact and the empirical evidence for the eff ectiveness of some of these interventions is rising. i must betray a generational bias by confessing a preference for direct connection between a patient with addiction and a therapist, particularly in the initial stages of the involvement. not everybody has access to or is just comfortable using a computer, and this certainly applies to some of our most vulnerable populations. younger generations weaned on computers as their preferred means of communication may be more comfortable with reduced human contact, but a third of our population at least is estimated not to be there yet. meanwhile, virtual care will get a boost and governments will recognize variations of this modality as a billable service. ( ) impetus for research-this pandemic raises so many questions on every front! how valid were the assumptions of epidemiological models resulting in a wide range of conclusions and fear of the unknown? will we get secondary epidemics? what are the determinants of interprovincial diff erences? the spectrum of addiction and mental health implications of public health measures remain a fi eld in its infancy. is the knowledge borrowed from natural and war time disasters valid against an "invisible enemy" mutating at regular intervals? will we need to "fl atten the curve" once or several times? a plethora of guidelines from various sources made their integration somewhat diffi cult. top of the list was the need for reliable, readily available testing. the uncomfortable interaction of public health policies and politics were on full display. politics played a major role in denying the recognition of a pandemic in most countries. on the other hand, once recognized, it also played a major role in marshalling resources. promises of a -min test, trials of hydroxychloroquine accepted by fda in a week, the building of fi eld hospitals in days in several countries were unheard of so far. closer to home, should liquor and cannabis stores be considered "essential services" to prevent panic buying? never to miss an opportunity, the internet gaming industry marketed #playaparttogether with a pretense of who support. ( ) social resilience and ingenuity-i should conclude by reminding ourselves that pandemics can also bring out the best in us. heartwarming displays of resilience will be remembered, such as the singing from balconies, the banging of pots and pans to recognize fi rst responders at the end of their shifts as well as the parades of cars in front of the nursing home to celebrate a grandparent's birthday. industrial ingenuity in retooling mobile hospitals and trials of vaccines, antibodies, and other therapeutics will have longstanding benefi cial implications. www.canadianjournalofaddiction.org editorial let's review these perceptions in june. the cja welcomes more empirically based chronicling of the pandemic. we are all in this together. nady el-guebaly, c.m., md, frcpc editor-in-chief, cja-jca canadian centre on substance use and addiction. the impact of covid- on people who use drugs collision of the covid- and addiction epidemics on grief and grieving: finding the meaning of grief through the five stages of loss world health organization. mental health and psychosocial considerations during the covid- outbreak key: cord- -quns b authors: cui, shunji title: china in the fight against the ebola crisis: human security perspectives date: - - journal: human security and cross-border cooperation in east asia doi: . / - - - - _ sha: doc_id: cord_uid: quns b the outbreak of the ebola virus disease (evd) in west africa became one of the worst disease-driven humanitarian crises in modern history. the crisis turned the global securitization of health issues into unprecedented levels, at the same time, aligned closely with human security frameworks and thus has significant impacts on national foreign and aid policies. china has played a significant role in the global fight against ebola, indicating important changes in its foreign policy orientations. based on the lessons drawn from china’s operation in africa, it is argued that states must transcend their narrow national interest and seriously consider the dignity and well-being of vulnerable people. in september , when the crisis was at its peak, the number of weekly cases reached almost , . by january , , when the world health organization (who) officially declared the epidemic to be over, the crisis had lasted nearly two years, during which time more than , people were infected with the virus and more than , lives were lost, mostly in guinea, liberia and sierra leone (who b; cbs ) . faced with such a devastating humanitarian crisis, the entire international community has shown great courage in fighting the disease. after the august/september announcement by the who that ebola was a 'public health emergency of international concern' and the united nations security council (unsc) declaration that ebola was a 'threat to international peace and security,' many countries as well as international organizations, non-governmental organizations, companies and individuals participated in the fight against this unprecedented challenge to humanity. china played a significant role in the international efforts to halt the spread of the ebola disease. through four rounds of emergency aid supplied in april, august, september and october , a total of million yuan (about usd million) was contributed to west african countries by china. in addition to financial and material assistance, china also sent more than , medical personnel to the region to help with local epidemic prevention and control work (nhfpc a; undp a) . this was unprecedented in the history of chinese foreign assistance. in fact, china has often been considered as lacking a philanthropic culture, and its international aid and financing models are frequently criticized as resource-backed and tied to aid in a way that simply serves the business interests of the country. thus, the chinese case raises intriguing questions, especially in terms of human security: what are the main motives and driving forces behind these efforts, and how effective are they? this chapter aims to answer these questions through the lens of human security rather than from a general foreign policy perspective. for this purpose, it begins by laying out the criteria and framework for the analysis. this is followed by an examination of china's efforts to fight the crisis. the chapter then goes on to evaluate these policies with a focus on effectiveness, empowerment and motives. based on china's experiences in africa, the concluding section draws some lessons for future human security-oriented foreign policies. when the un security council adopted resolution on september , , declaring the outbreak of ebola in africa to be 'a threat to international peace and security,' the ebola crisis was no longer a mere health issue but an international security crisis (unsc ) . of course, it was not the first time that the security council had acknowledged the link between health and security. in , the council had recognized the hiv/aids pandemic in resolution (unsc , ) , and declared it to be 'a risk to security and stability,' although its main concern was on the 'regional effects' in africa (deloffre a) . resolution is important in terms of human security because the council clearly focused not only on issues such as preventing wars and control of the proliferation of weapons of mass destruction but also dealt with matters concerning human security such as disease (poku , ) . therefore, resolution constitutes a clear securitization of public health issues within the un system. following the ebola crisis, resolution and the creation of the united nations mission for ebola emergency response (unmeer) in pushed the scale and depth of securitization to an unprecedented level, while at the same time brought the securitization processes into close alignment with human security frameworks (snyder ) . the question to be asked in this context is, therefore: what is meant by human security, and what counts as appropriate foreign and aid policies toward human security threats? since its introduction in (undp ) , the concept of human security has increasingly been reflected in global governance and in the foreign and aid policies of many countries. yet the kind of definition one adopts, narrow or broad, will have very different operational and policy implications. in keeping with the approach to human security taken by jica and many east asian countries (see chapter in this book ; tanaka ; jica ) , this chapter takes a broader concept as its working definition and uses this to identify the three features of human security. first, the causes and effects of human security can be far-reaching and multifaceted, and if we underestimate the complexity of such threats, we can never have adequate policies toward human security practices. secondly, human security and human development are so closely related that, even though we can conceptually separate them, we must be aware of the interconnectedness between the two at the operational level (cui ) . amartya sen made the point comprehensively. he argued that on the one hand, human security demands both 'protection' of people from a variety of dangers, and 'empowerment' of people so that they can cope with, and when possible overcome, these hazards. on the other hand, human development is concerned with 'removing the various hindrances that restrain and restrict human lives and prevent its blossoming,' and hence goes beyond 'overarching concentration on the growth of inanimate objects of convenience' (chs , - ) . such a comprehensive understanding is at the heart of his conceptualization of 'development as freedom,' in which poverty, one of the central concerns of human security, is no longer premised solely on income, but seen as a non-fulfillment of basic human rights (sen ) . thirdly, when human security is threatened by conflict situations, natural disasters or pandemics, it is often the case that the most vulnerable people in society are the ones who are most threatened. given these features of human security, what kinds of policy tools are to be considered as most appropriate and effective? tanaka ( , - ) distinguishes between two types of human security instruments: 'fundamental measures' that affect the underlying causes of human security, and 'defensive measures' that affect consequences. this is very similar to johan galtung's ( ) distinction between 'positive peace' and 'negative peace,' because fundamental measures may bring positive peace, while defensive measures are more likely to bring negative peace. for galtung, peace can be defined in a negative way, meaning the absence of violence (both direct and structural). yet more importantly, peace can also be defined positively, that is, the construction of an appropriate environment for lasting peace. in other words, the conditions for positive peace may be built through a process analogous to the 'building of a healthy body capable of resisting diseases, relying on its own health forces or health sources' (galtung , - ) . drawing on these ideas, this chapter is framed around three measures by which human security policies can be assessed. the first measure is effectiveness. once human security threats have occurred, how should we respond to the problem more effectively? the issue here is how swiftly and decisively can a country reduce the negative impacts of disease and human suffering. this is in line with tanaka's defensive measure or galtung's negative peace. effectiveness means more than speed, scale and comprehensiveness; it also refers to the ability to cooperate with a variety of actors to tackle human security threats. speed and scale are extremely important; however, if they are pursued singlehandedly, their impact remains limited. cooperation is imperative when trying to effectively handle deadlier challenges. the ebola crisis is a good demonstration of how a problem goes beyond the capacity of a single state. unmeer was created specially to coordinate a variety of actors to fight the crisis more effectively. thus, both comprehensiveness and cooperation are required if human security policies are to be effective. the second measure is empowerment. if human security practices are only prepared to tackle problems once they emerge, only negative peace can be achieved. taking individual health as an example, although a person may be cured of a disease, if they do not build up their bodily conditions, illness will reoccur. empowerment is more closely related to dealing with structural violence as the underlying cause, building capacities, and creating a more secure environment, so that the occurrence of human security threats can be prevented or the likelihood of them occurring be reduced (cui ) . in this way, even if threats occur, people have the ability, or at least an increase in the ability, to address those threats on their own. thus, if the first evaluate of effectiveness is used to assess more short-term defensive approaches, empowerment is used to evaluate longer-term fundamental approaches to human security. thirdly, in addition to the above measures, motives or moral imperatives are important in assessing human security policies. traditionally, theorists, particularly realists, emphasized national interests when measuring national foreign policies. hans morgenthau ( morgenthau ( , argued explicitly that a 'foreign policy derived from the national interest is in fact morally superior to a foreign policy inspired by universal moral principles.' of course, morgenthau did not deny political morality and prudence, or the need for a logic of consequences to save policy makers from both moral excess and political folly. however, because most human security-related governance activities do not directly relate to national interests in the narrow realist sense, the notion of raison d'état provides poor guidance and does not fully explain the current global efforts to achieve human security. thus, the practice of human security requires a certain degree of consideration of those people who are socially vulnerable, and concern should be given to the possibility of their dignity being exposed to existential threats. the ebola virus disease (evd) in west africa broke out in december and the who put out its first alert in march . what followed was the largest, longest, and most severe and complex outbreak of the virus since it was discovered in (who a). although at the initial stage the impact of the outbreak was underestimated, following the declaration of emergency and threat by the who and the unsc in august and september , the international community has made great efforts and shown solidarity in the fight against the deadly disease. among the countries fighting evd, traditional donors, such as the usa and the uk, played a leading role. by october , the us government was ranked as the largest donor having contributed around usd million in aid, with the uk coming in second with about usd million (who a). yet, the crisis also saw intense media attention given to some non-traditional donors, like china. by october , china had contributed close to usd million in financial aid. although this was much lower than that of the usa, it was still above the contribution of traditional donor countries such as france, japan and canada (undp a; see also fig. . ). accordingly, china's role and its impact on human security merit more detailed examination. china's participation in fighting the ebola epidemic is regarded as being historic, marking the first time it offered such aid to help combat a foreign health crisis (tiezzi ) . the chinese government also admits that it was the largest medical aid program to be implemented by china at the time (nhfpc b). china's role in fighting ebola was particularly important in the early stages and was in stark contrast to the delayed response of the rest of the international community. for instance, even though the who was first alerted to the outbreak on march , , it was not until april that médecins sans frontières (msf) first warned that ebola was getting out of control. by june, the spread and scale of the epidemic was obvious to many experts, yet it was not until august that the who declared that it was a public health emergency. as a result, the international response generated criticism as being both too small and too slow (dearden ; grépin ) . in comparison, china's response was swift. there are two reasons for this swift response: first, given china's long-term medical cooperation with african countries, many doctors and medical staff were already present in african countries when the outbreak began. for example, when the epidemic first emerged in guinea, a chinese medical team of nineteen people from beijing's anzhen hospital was working at the china-guinea friendship hospital in conakry, the capital of guinea. during this time, one infected patient was treated in the hospital without anyone realizing it was ebola and was thus faced with the risk of death. secondly, the chinese experience with sars in and its struggle to stop its spread, coupled with an awareness of the weaknesses in the medical system in west africa, made chinese officials and medical experts particularly alert to pandemics in west africa. in fact, the weak healthcare systems in all three countries were emphasized by many medical experts after ebola broke out. as marie-paule kieny ( ) notes, ebola became epidemic in guinea, liberia and sierra leone in large part due to their weak healthcare systems. indeed, all these countries lack adequate numbers of qualified health workers, particularly in rural areas. other limitations included weak or absent rapid response systems, and a lack of electricity and running water in some health facilities (kieny ; who c) . in march , when the outbreak of ebola in africa began to be reported, the news placed policy makers and medical experts in china on high alert. immediately, high-level meetings were held with the ministry of health calling for discussions on the ebola virus and how to help africa deal with it. among those involved in the meetings was the deputy director of the center for disease control and prevention (cdc) in beijing, he xiong, who was a frontline veteran of china's battle with sars. in april , the chinese government announced its first emergency assistance plan, under which it would send disease prevention and control materials worth million yuan (about usd , ) to guinea, liberia, sierra leone and guinea-bissau; by may , the assistance had arrived (china daily, october , ; nhfpc a) . by june , , the ebola situation had become even more urgent as it had reached the liberian capital, monrovia. six days later, the death toll had risen to and it had officially become the worst ebola outbreak on record (nhfpc ). in august, the epidemic accelerated as the total number of cases reached almost , , with more than , deaths in guinea, liberia and sierra leone alone. cases of infections among american, british and spanish citizens were also reported. on august , , the who declared that the epidemic had gone from being an african problem to an 'emergency of international concern' (who b). this situation alerted the top chinese leaders. on august , , beijing announced its second round of assistance, whereby it would provide emergency anti-epidemic supplies worth million yuan (about usd . million) to the three most affected countries. the supplies were mainly medical protective clothing, sterilization equipment, drugs and other much-needed medical equipment and supplies. due to the urgency of the situation, china even used chartered planes to deliver medical supplies, which arrived on august , just one week after the announcement. the initial aid was followed by another three chinese medical teams dispatched across west africa to help with prevention and treatment. by this stage, more than medical workers had been dispatched (china daily, september , ) . the situation further developed and reached a devastating level. by september , the total number of infected cases had reached , including deaths (medical express, september , ) . two days later, the unsc declared the outbreak of ebola to be a 'threat to international peace and security' (unsc ). on september , the unmeer, the first-ever un emergency health mission, was formed. this mission was led by a full range of un actors, who utilized their expertise under the leadership of a special representative of the secretary general. it was in such crisis atmosphere that many countries pledged more aid and manpower to help. on september , us president barack obama announced 'major increases' in the us response to fighting ebola in africa including up to troops, material to build field hospitals, additional healthcare workers, community care kits and badly needed medical supplies (new york times, september , ) . in a speech to the un high-level meeting on the response to the evd outbreak on september , , japanese prime minister shinzo abe also promised that japan would provide , sets of protective gear for medical personnel working to combat ebola in africa. in october, japan used civilian aircraft to deliver , sets of protective gear to liberia and sierra leone (asahi shimbun, february , ) . in september, as its third phase of assistance, china increased its contribution significantly by opening a biosafety lab and providing protective treatment supplies and food assistance. additionally, to help sierra leone improve lab testing, china sent a laboratory team of (thirty doctors and twenty-nine laboratory technicians) to work at the sierra leone-china friendship hospital (china daily, september , ). on october , china announced its fourth round of emergency aid worth million yuan (usd million), which would mainly be used to finance the construction of a -bed treatment center in liberia, where the epidemic was most serious. as the chinese foreign ministry explained, the treatment center, which was completed on november , would be managed and operated by a medical team from the people's liberation army (pla) (xinhua, november , ). the treatment center was able to accept patients for observation and testing from december , (nhfpc b). the aid package also included sending medical equipment and materials, such as ambulances, motorcycles, , healthcare kits, , pieces of personal protection equipment, and other materials (larson ) . china continued its commitment to fighting ebola after these four phases of contributions, as lin songtian, director of the foreign ministry's african affairs department, stated, 'china's assistance will not stop as long as the ebola epidemic continues in west africa' (xinhua, october , ) . thus, in early november, the nhfpc announced that china planned to send medical workers and experts to west africa over the months that followed (xinhua, november , ) . in february, china handed over a p -level biolab to sierra leone as part of its continued contribution to fighting ebola; it also delivered a consignment of metric tons of food assistance for distribution to ebola patients at various treatment units across the country. evaluating china's role: an emerging human security-oriented foreign policy? from the above discussion, it is not difficult to see how china actively participated in the global efforts to address the ebola outbreak. how then should china's role be assessed through the specific lens of human security? what lessons can be drawn for future human security-oriented foreign policies? the following section will analyze china's role in terms of effectiveness, empowerment and motives. as previously argued, effectiveness comprises both comprehensiveness and the ability to enhance multiple-level cooperation. first, china's assistance is considered as comprehensive and wide-reaching. its contribution of personnel is particularly highlighted compared with many other countries, especially asian countries. at a news conference in seoul on november , , the world bank group president, jim yong kim, lamented the fact that although they may have the capacity, many asian countries were not doing enough to help. he called upon asian leaders to send trained health professionals to west african countries (aljazeera, november , ) . the lack of assistance by asian countries is true to some extent. japan, for example, while making significant financial and material contributions lagged behind many other countries in terms of the provision of personnel. by the end of , japan had sent a total of twenty japanese experts to participate in who missions to liberia and sierra leone, two self-defense force (sdf) personnel to the headquarters of the us africa command (africom) in germany to support liaison activities, and one to unmeer as a senior advisor (government of japan ). there were suggestions from japan's defense ministry that a ground sdf unit would be dispatched to join the fight in sierra leone. the plan was submitted to the prime minister's office on february , , and called for gsdf personnel to begin operations in april, with a possible maritime sdf contingent to serve as the base of operations. however, for many reasons japan did not go ahead with the plan. this decision generated some criticism because although prime minister abe promotes a vision of 'proactive pacifism,' he chose to put japanese lives and his government's own political interests ahead of global well-being (pollmann ; the japan times, february , ) . south korea made a large step in its contribution to international personnel at this time. in addition to the usd . million of assistance it had already provided, between december and april , seoul sent three emergency relief teams (a total number of thirty people), comprising mostly skilled military and civilian healthcare workers, to west african countries to carry out medical activities (the korea times, october , ; china news, april , ) . this represented the first time that the south korean government had sent an emergency relief team to fight the outbreak of an epidemic overseas. in comparison, china's participation was much swifter and of greater weight. the un secretary general ban ki-moon acknowledged 'the speed and breadth' of china's response and emphasized the commitment and dedication made by chinese medical staff to fighting ebola (china daily, february , ) . but, there were also other countries who made significant contributions, including personnel, to this global effort to fight ebola. since mid-september , the usa had shown renewed engagement and significantly enhanced the global scale of the fight against ebola. over the course of the epidemic, the usa deployed more than personnel to the affected region ; as a superpower and as a longstanding traditional donor country, the usa did play a leading role in this humanitarian effort. nevertheless, as a rising great power and as a non-traditional donor country, china's growing role in international aid and global governance is commendable for its willingness and comprehensiveness. secondly, in terms of cooperation, china's role is, however, less straight-forward. the complexity and devastation of the ebola crisis again demonstrated the value and necessity of cooperation among a variety of actors. of course, in the process of engaging in the global effort to fight ebola, china did cooperate with many countries and international and regional organizations by providing financial support to the un, the who and the au, and assisting them in playing leading and coordinating roles. china also made many bilateral and trilateral agreements to combat the unprecedented spread of ebola, including with the usa, france and the uk (focac ). the health ministers of china, japan and south korea also agreed to boost information-sharing on the ebola epidemic and countermeasures against other types of diseases, such as pandemic influenza (the japan times, november , ). however, in comparison with many traditional donor countries, china had less experience of coordinating with non-governmental actors, and the ebola crisis, in a sense, highlighted the shortcomings of china's private sector participation and its philanthropic shortfalls (rajagopalan ) . even though at the government level china contributed over usd million to fight ebola, at the private sector level it donated little to the cause. many firms and business people in china still assume that the chinese government should take the lead on international assistance. in a deeper sense, this philanthropic shortfall is the result of china's international aid tradition, which has been predominantly bilateral and government-to-government. this is clearly revealed in china-africa relations. since china began its assistance to africa in the s, it has been the government that has initiated the sending of medical practitioners and the building of roads and railways (chan , - ) . even at present, this tendency has not changed very much; hence, the aid commitment under the multilateral mechanism of the forum on china-africa cooperation (focac) is also realized mainly through a bilateral mechanism (xu ) . with global multilateral cooperation frameworks growing in sophistication, china faces the challenges of how to better integrate itself into the multilateral development framework. to what extent has china's approach to the ebola crisis contributed to empowerment rather than just protection? as argued earlier in this chapter, empowerment refers to a longer-term positive/fundamental approach to human security that looks at the underlying causes of human security threats and should ultimately lead to an improved capacity to overcome threats. strictly speaking, capacity building and empowerment may not be entirely identical, as the former is more related to organizational capabilities, while the latter is more concerned with people. yet, the two are closely related to each other, and building organizational capabilities such as proper health systems can directly and indirectly enhance individual health resilience in the long term. thus, this chapter examines the following two aspects in detail: china's effort in offering help to build public healthcare systems and its active engagement in african economic and social reconstruction. first, in fighting the ebola crisis, china has not only devoted itself to tackling the deadly disease but has also offered valuable help to african countries to improve their capacity to respond to public health emergencies. if china's four major rounds of assistance between april and october were dedicated mainly to stopping the spread of the ebola epidemic, since then china has focused more on long-term capacity building (embassy of the prc ). in november , china sent its public health training team to sierra leone to study the ways they could carry out training for public health professionals in west africa. the team was to smooth the way for large-scale training programs in the future. by august , chinese public health training teams had trained more than , residents, including medical staff, community healthcare workers, government officials and volunteers. using china's fight against sars as a way of sharing their experiences, the training teams were able to deliver useful prevention and control knowledge and skills to the participants (nhfpc a; embassy of prc ). indeed, empowerment through improving regional health systems has become an important part of the china-africa health cooperation. at the second ministerial forum of china-africa health development in early october , ministers emphasized the importance of african people being able to access quality essential health commodities, medicines, vaccines and medical services (nhfpc c). to that end, china pledged to send medical workers to africa in the next three years, and it encouraged ten of its large pharmaceutical and medical equipment enterprises to cooperate with various african counterparts, through measures such as technology transfers in the production, maintenance and distribution of quality pharmaceutical products (china daily, october , ) . secondly, along with establishing and improving public health systems, poverty reduction and economic and social reconstruction have become china's key goals in its efforts to address the ebola epidemic. the chinese foreign minister wang yi emphasized this point while on a visit to the three countries worst hit by ebola, by saying that 'poverty was the root cause' of the ebola outbreak (xinhua, august , ) . from china's perspective, the fundamental solution to preventing the reoccurrence of ebola and other epidemics of this kind is to find effective paths to eliminate poverty and achieve development as soon as possible. for this purpose, china's cooperation would prioritize areas such as infrastructure building, resumption of trade and export, food security and other areas to enhance their resilience to crises (xinhua, august , ; august , ) . of course, rebuilding the fragile health system and enhancing socio-economic reconstruction in these countries will not be easy and will require a much longer time-period and persistent efforts. in this sense, whether wang yi's visit to the african continent will lead to more substantial engagement from china, or whether it will bear positive fruits, remains to be seen. however, china's commitment to african development and to the recovery of the three countries was demonstrated at the forum on china-africa cooperation (focac). indeed, in the past three focac meetings, china has consistently doubled its financing commitment to africa-from usd billion in to usd billion in and usd billion in (sun ) . additionally, at the forum, china pledged usd billion worth of assistance and loans for african development. it also specified ten areas of cooperation and assistance, including agriculture modernization, public health and poverty reduction that it would engage in. in the declaration, china promised it would transfer agricultural technology to africa; cancel outstanding debt for some of the poorest african countries; help build an african center for disease control; and back cooperation between twenty chinese and african hospitals. china also hoped to explore the possibility of linking china's belt and road initiative and africa's economic integration. if these efforts can be materialized, they would certainly have a positive impact on africa. finally, why did china participate so actively in the global efforts to contain ebola? as discussed, realist notions of raison d'état cannot provide sufficient answers about the international efforts for human security purposes. the question is this: to what extent can china's role transcend this notion of national interests? of course, one cannot deny that china's national interests are growing in africa, including in the three most affected countries. when evd emerged, there were approximately , chinese nationals living in the three afflicted countries (beijing youth daily, august , ) . moreover, when chinese foreign minister wang yi visited the three countries in august to prepare for the post-ebola reconstruction, he promised more funding and joint projects including infrastructure building, and resumption of trade and export (xinhua, august , ) ; this was an indication of china's growing economic interests in these countries. however, national economic interests alone cannot explain china's proactive engagement in the global fight against ebola, given that these countries are the least developed countries in africa. if china was purely seeking economic interests in the area, it should have invested in countries that had a greater chance of return. therefore, we should examine the ways in which human security as a fundamental value has an increasing impact on national foreign policy and strategic choices. china's active participation in and significant contributions to the global fight against ebola indicates its 'growing position within the international community as a global actor in humanitarian aid' (undp a, ) . it also reflects some important changes in its foreign policy orientations, particularly in foreign aid strategy. this is clear in china's second white paper on foreign aid (wp ii) (state council of china ). in , china published its first-ever foreign aid white paper (wp i), which was already indicative of its effort and strategy to become a responsible great power in international society. by moving its focus from its own development to the provision of assistance to other developing countries, china is 'fulfilling its due international obligations' (state council of china , ), and is enhancing its image as a responsible great power (liu and huang ) . in wp i, the underpinning principles for china's foreign aid were clearly put forward: the 'five principles of peaceful coexistence' and the 'eight principles' for economic aid and technical assistance to other countries. china often defended its role as being 'an alternative to western donors who impose more conditions on recipients' (state council of china , - ) . by comparison, there are some noticeable modifications contained in the wp ii, which sets out the following two areas-'helping improve people's livelihood' (改善民生) and 'promoting economic and social development'-as its major foreign aid objectives (state council of china , - ) . of course, this does not mean that china has abandoned the principles of non-conditionality, non-interference, and respect for sovereignty, which continue to underpin the basic principles of china's foreign and aid policies. however, the growing emphasis on poverty reduction (减少贫困) and improvement of people's livelihood (改善民生) means that these are increasingly attuned to those values of human security which have been endorsed and promoted by the un and the international community (state council of china ; undp b). the shift also reflects some important changes in the way china assesses global security threats and identifies its national interests; this is increasingly in line with the broader definition of human security. as china's foreign aid specialist wang xiaolin argues, the trend of china's foreign assistance has changed significantly from being driven by ideology and only aiding socialist countries to being based on its assessment of global security challenges. china sees the global security agenda, such as poverty reduction and tackling climate change, as being part of its foreign aid agenda, and hence its foreign assistance is more consistent with the millennium development goals (now the sustainable development goals) (wang ) . importantly, as the global security agenda expands, human security norms such as poverty reduction and environmental responsibility have emerged and been institutionalized as important norms and institutions in international society (kozyrev ; kopra ) . the global adoption of mdgs ( ) and sdgs ( ) has hugely contributed to the institutionalization of a human security norm in international society. building on the success of the mdgs, the sdgs with goals and targets are particularly determined to eradicate poverty and hunger in all their forms, which are the core elements of human security. moreover, the sdgs are also truly global in nature and universally applicable, and all countries have a shared responsibility to achieve them (unga ) . in this way, human security norms have become an important and legitimate basis for moral claims within international society and even have an impact on 'the criteria for rightful membership' of international society (falkner and buzan , ) . given that china is so eager to build its global image as a responsible 'great power,' it cannot ignore these changes. thus, the argument can be made that china may not entirely abandon its national interests and would not promote its foreign aid purely out of altruistic aspirations; however, it does indicate the ways in which china assumes and identifies its national interests in the changing international environment of the twenty-first century. in other words, china is increasingly seeing its national interests and security in terms of the interests and security of international society as a whole; in so doing, china is showing a growing sense of raison de système in global international society, in which human security considerations are becoming an important part of its foreign policy projection. china's participation in the global effort to address the ebola outbreak provides us with several important lessons as to how human security-oriented foreign and aid policies should be conducted, especially in an environment of emerging and complex human security challenges. the destructive nature of the ebola crisis and the devastation it brought with it again demonstrated the changing nature of global security threats. as ginsburg vividly illustrates: 'it is shocking to realize that a tiny virus with just a handful of genes can fracture families, shred communities, destroy national economies and destabilize whole regions in just a matter of months. but this is what we are witnessing with ebola.' (guardian, october , ). diseases like ebola can become as serious and deadly as the threats caused by conflicts and even wars. moreover, as viruses know no borders, once a breakout occurs, it can easily affect people across countries, regions and worldwide. as is often the case, it is always the most vulnerable individuals and groups who are the most affected. given the complexity and potential destructiveness of infectious diseases, future health security governance should be prepared with greater care. first, it is imperative that early warning systems for future health crises should be developed at the national, regional and global levels, especially in low-and middle-income countries. one of the important lessons that was drawn from the ebola crisis was the weak (or even lack of) healthcare systems in the three most affected countries. according to anthony fauci, a health expert based in bethesda, usa: 'if there was a system to have recognized and stopped the outbreak that began with the child in guinea in december , we might have avoided the explosive outbreaks in sierra leone and liberia' (kupferschmidt ) . it is in this sense that the un secretary general ban ki-moon stressed 'the need to strengthen early identification systems and early action' (snyder ) . the east asian region has also been faced with many health and security challenges, for instance, the outbreaks of sars in and h n bird flu in - , both of which had the potential to turn into pandemics (fidler ) . the sars outbreak did indeed spark regional health security initiatives (caballero-anthony and amul , ). yet, to prepare for complex challenges in the future, more enhanced and sophisticated regional public health systems are required. secondly, the ebola crisis strongly demonstrated the value of cooperation between actors at various levels, including both state and nonstate actors (nsas). particularly, cooperation between external militaries and ngos is a notable development. both china and the usa deployed many troops to help control the epidemic. importantly, some ngos, such as msf, which had previously refused to work with national militaries, are now calling for military intervention as part of outbreak responses. in fact, it has been proven that with their adaptability, discipline, ability to operate in challenging environments and logistical capabilities, the military can be a particularly valuable resource during large-scale public health crises (edelstein et al. ) . however, it should be emphasized that in this situation the operationalization of the role of states and their militaries cannot be properly understood in the traditional sense of state centrism. importantly, as the most powerful state in the world, the usa acknowledges that global health security is a 'shared responsibility' that cannot be achieved by a single actor or sector of government (white house, september , ) . thus, in any future health security governance, ngos and other nsas should become important partners, and through state-ngo or public-private partnerships (ppp), they should achieve their common objectives through collaboration. in addition to public-private partnerships, future health security governance should also pay sufficient attention to the idea of 'local ownership,' which values cooperation between international actors and local actors. exploring the concept of 'local ownership' in the field of conflict resolution and peacebuilding, shinoda ( , ) argues that unless it is solidly rooted in local society, conflict resolution and peacebuilding would end up becoming 'superficial' and 'short-sighted.' this is true with international development cooperation, because the ultimate aim of such cooperation should empower stakeholders of a local society to enable them to take responsibility for dealing with the situation. finally, the close link between health security and poverty is another case in point. indeed, the fact that 'poverty and infectious diseases 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fazhan qilai wang yi tan xifei sanguo xing forum on china-africa cooperation: creating a more mature and efficient platform key: cord- -kap tdiy authors: srinivasan, malathi; phadke, anuradha jayant; zulman, donna; israni, sonoo thadaney; madill, evan samuel; savage, thomas robert; downing, norman lance; nelligan, ian; artandi, maja; sharp, christopher title: enhancing patient engagement during virtual care: a conceptual model and rapid implementation at an academic medical center date: - - journal: nejm catal innov care deliv doi: . /cat. . sha: doc_id: cord_uid: kap tdiy stanford healthcare shares the lessons learned during its rapid deployment of virtual visits during the covid- pandemic. stanford primary care and population health clinics comprise thirteen clinical groups including general primary care, senior care, urgent care, employer-based clinics, concierge medicine, and coordinated care. during the first two months of virtual health roll-out, our stanford primary care providers conducted over , video and , telephone visits. virtual health encompassed virtual visits and all of the clinical activities surrounding the clinical care which were no longer conducted in person. within four weeks after initiating the virtual health program, we conducted more than interviews with staff and providers (physicians, advanced practice providers, medical assistants [mas] ) in stanford primary care to understand their experiences around virtual health. despite high provider and patient satisfaction, technical limitations and system readiness challenges hindered visit quality, and from the provider viewpoint, left some patients unprepared for virtual visits. providers observed that patients with cognitive impairment, language barriers, or technology access concerns experienced disproportionate challenges. providers struggled with platform connectivity, the provider-directed patient self-exam, and establishing an emotional connection with patients. some medical assistants (mas) felt unfulfilled, with less direct patient contact. providers observed that patients with cognitive impairment, language barriers, or technology access concerns experienced disproportionate challenges. providers struggled with platform connectivity, the provider-directed patient self-exam, and establishing an emotional connection with patients." the next six weeks saw a period of creativity, led by clinic mas who spontaneously formed improvement teams to address identified challenges. these were later brought together centrally to coordinate clinic improvement efforts. at ten weeks, we surveyed all primary care providers system-wide to identify general issues relating to provider burnout. we re-conceptualized our engagement strategy and identified new areas for growth. the virtual health program delivered extremely variable quality of care, for several reasons. in virtual health, more responsibility is placed on patients to prepare for the visit, to examine themselves and to generate their own health data, while providers are expected to make sound decisions with a very different set of data. given the circumstances of the transition, many patients became highly activated, whereas others were left behind. our prior systems were optimized for in-person care, and were not as suitable for virtual health care delivery. several factors were difficult or in some cases impossible to adapt to virtual health. in-person visits relied on our medical staff to obtain in-person patient updates, vital signs, and " perform detailed follow-up. patients had time to prepare for their visits while in the waiting area, center, and develop their visit agenda. provider exams, routine imaging and procedures occurred immediately on-site. rapid, direct communication around patient encounters by providers and medical assistants enhanced care follow-up and continuity, while informal face-to-face communication with colleagues and specialists supported clinical decision-making. we developed a virtual health patient engagement model that incorporated principles of the nam quintuple aim, which evolved from the nam triple aim (quality of care, cost, patient experience) to include patient equity and inclusion, and prevention of provider burnout. drawing from the wellmd model, we considered factors to support patient engagement in virtual health, including system/technology support, support by clinical teams, and customized support for self-care ( figure ). a foundational step to building the infrastructure for virtual health was to convert key elements of the in-person visit to the virtual experience. this included developing processes for virtual rooming, virtual waiting room, virtual visit, virtual check-out, and continuous virtual care & support ( figure ). providers and mas quickly recognized that many patients were unprepared for their video visit. at several primary care sites, care teams met to develop and pilot independent solutions for pre-visit preparation. mas experimented with virtual rooming strategies, depending on their resources, ranging from low touch (secure patient portal message with written rooming questions/screenings) to medium touch ( - minutes phone calls with chief complaint and health maintenance review) to high touch ( -minute phone or video visits for comprehensive agenda setting, health maintenance review, behavioral health screening, and medication review). after three weeks of experimentation, mas and clinic leadership had division-wide meetings to share and adopt best practices and develop new workflows around health maintenance (hedis and mips measures). two weeks later, about % of patients had a virtual rooming visit with a ma. providers reported that patients undergoing virtual rooming were generally more prepared for and more engaged in their video visit. patients were asked to log on to the patient video portal - minutes in advance of their provider visit, to ensure that they didn't have videovisit access problems, to verify medications, and to help the clinic keep running on schedule. when patients logged on, they could complete questionnaires, prepare for their visit, or watch videos related to their health (chf only, at this writing, with expansion plans). based on provider/patient feedback, we have begun plans for an interactive virtual clinic platform to maximize the utility of this waiting time. teams were concerned that critical issues in scheduling/follow-up would fall through the cracks with virtual health implementation. employer-based clinics and coordinated care recognized that many patients did not want to discuss health maintenance when they had acute issues. to address this gap, mas called patients after video visits to help with scheduling procedures and labs, and also conducted appropriate health maintenance screening for depression, tobacco cessation, and more. positives screens in the after-visit setting triggered actions such as behavioral health follow-up. mas called patients after video visits to help with scheduling procedures and labs, and also conducted appropriate health maintenance screening for depression, tobacco cessation, and more." during program evaluation, providers reported wide variation with establishing patient rapport and conducting the virtual physical examination. two education teams began working on engagement and physical examination best practices. to help providers achieve meaningful connection with virtual health patients, the stanford presence group developed and distributed five best practices for telepresence communication : • prepare with intention (pause, refresh, focus, prepare) " • listen intently and completely (remain visible on screen, lean in, maintain eye contact, communicate through facial expressions, avoid interruptions) • agree on what matters most (establish a virtual visit agenda, incorporate patient priorities/ goals) • connect with the patient's story (engage virtually with the patient's home environment and social support) • explore emotional cues (look for/validate emotional cues in facial expressions, body language, changes in verbal tone/volume). the provider-directed patient self-exam recast the patient's role from examinee to both examiner and examinee. "exam coach" was added to the provider's role. based on provider feedback, we developed "practical tips" videos for the most useful outpatient problem-focused examination sets, including: • common concerns: upper respiratory tract infection, shoulder pain, back pain, knee pain, • critical conditions: screening stroke exam, congestive heart failure/cardiovascular exam, pulmonary exam • sensitive examinations: male and female genitourinary exams. an initial video to teach providers how to coach self-exams on upper respiratory tract, low back pain and shoulder pain was viewed , times on youtube within a few weeks. research has begun on validating these measures, and developing additional exam videos for both providers and patients. to address the need for targeted support for patient self-care, including education and integrated home monitoring, we developed and have begun to build out the following resources. over two months, we strengthened the virtual support programs that provided longitudinal health monitoring and support for goals of care. we launched a digital lending library to send internet of things (iot) devices to appropriate patients, allowing for home-monitoring of parameters such as blood pressure, weight, and pulse, with these data streamed to our electronic health record system (ehr). we have several hundred devices available, funded by grants. technology/ai-enabled care within a month of launching virtual health, several care teams converted their in-person programs to virtual programs, adding new offerings to support self-care. chronic disease management and group education teams converted existing diabetes, weight management, intensive behavioral health, and depression programs to virtual programs, adding both group classes and one-on-one support. psychologists at one site offered new virtual support groups for stress management. to address covid- health concerns, we provided advanced care planning large (> person) and small ( person) group classes. in the two months since near universal virtual health program implementation at stanford, we developed new models and processes to drive patient engagement in the virtual setting. central to our implementation was a combination of individual program innovation, robust rapid program evaluation, centralized program development, and a willingness to foster creativity at every level. this transformation took thousands of hours to develop and hundreds of people to deploy, and, we hope, has positively impacted our larger community. while we believe that elements of virtual health are here to stay, virtual health has not yet been proven to achieve the quintuple aim, including improving equity in care, promoting joy in practice, and bending the cost curve." we are still building out our virtual health programs. the future of post-pandemic virtual health is unclear. while we believe that elements of virtual health are here to stay, virtual health has not yet been proven to achieve the quintuple aim, including improving equity in care, promoting joy in practice, and bending the cost curve. during this rapid program growth, we learned valuable lessons which will inform our future work in virtual health. • equity and justice as core virtual health principles:while virtual health may increase health care access for many patients, it may exacerbate equity-related issues for those with limited access to advanced technologies or limited technology literacy. we should carefully evaluate the technology gap in our patient populations and augment with alternatives where needed. for example, some patients may not have smartphones, but may still be able to interact with care teams via sms. • rapid evaluation, rapid change: rapid qualitative assessment was critical to making mid-course corrections, to gain a deeper understanding of participant experiences. to do so, we used highefficiency qualitative evaluation rather than traditional longer form qualitative evaluation. • change-makers as interviewers: unlike traditional third-party qualitative interviews, many interviewers were qualitative research trained faculty who were involved in program development and implementation. for instance, population health leads heard firsthand about mas' concerns regarding their lack of patient contact. in response, they expanded the virtual rooming project to increase high quality interactions between patients and mas. • empowering creativity: improving patient engagement was not a "top down" process: all individuals within the health system were encouraged to innovate, in a coordinated manner. for instance, each clinic experimented with ways to address patient needs for visit preparation, layering on additional components as new needs emerged. • highest level of the license: the foundation of many health systems, including ours, is medical assistants. , these well-trained, compassionate personnel are often overlooked as sources of innovation. yet, their deep connection to patients, and understanding as a bridge between patients and providers gives them a unique vantage point as innovators. for instance, the technology access program start began as one bilingual ma reached out to help her spanish language patients navigate the virtual health app and ensure their comfort with the technology. • patient as partner: patient engagement is critical to the success of health care endeavors to improve quality of care. - with the initial press of virtual health implementation behind us, we can now partner more deeply with patients and our existing patient advisory groups to develop and test future engagement strategies. while devastating, the covid- pandemic has created an opportunity to re-think the very core of care delivery. the future of health care will likely involve a balance of in-person and virtual care, with the integration and strategic use of different technologies playing a vital role. , as the health care community collectively innovates, we are asking fundamental questions regarding the way in which we practice medicine. we are considering what patients really need from our health care system, the role of the clinical encounter, and the unique advantages/issues of providing care in the digital sphere. while these questions may not be fully answerable now, if virtual health is to be a significant part of post-pandemic health care, we need to begin to address these issues from the patient's perspective. rapid system transformation to more than % primary care video visits within three weeks at stanford: response to public safety crisis during a pandemic virtually perfect? telemedicine for covid- engaging patients to improve quality of care: a systematic review tele-presence : a ritual of connection for virtual visits -stanford center for continuing medical education -continuing education (ce) addressing equity in telemedicine for chronic disease management during the covid- pandemic comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the veterans health administration the expanding role of the medical assistant. pop health mat new roles for medical assistants in innovative primary care practices a multilevel analysis of patient engagement and patient-reported outcomes in primary care practices of accountable care organizations the association between patient engagement hit functionalities and quality of care: does more mean better? what the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs rapidly converting to "virtual practices": outpatient care in the era of covid- key: cord- -jps j a authors: miranda, mary elizabeth g.; miranda, noel lee j. title: rabies prevention in asia: institutionalizing implementation capacities date: - - journal: rabies and rabies vaccines doi: . / - - - - _ sha: doc_id: cord_uid: jps j a rabies in asia and africa contributes to over % of human rabies deaths that occur in the world today. the vast majority or % of these deaths are in asia. practically, more than four billion people in asia or about % of the world’s population are at risk of getting rabies where an estimated % of documented human cases are from an infected dog bite. canine-mediated rabies is one of the few communicable diseases that can possibly be eliminated by currently available vaccines and tools for veterinary and public health interventions. with a more comprehensive and integrated approach, it is expected that dog rabies will be eliminated in target areas, and there will be an eventual decline and disappearance of human rabies cases. the burden of rabies is primarily on human health but the disease control has to be focused on the animal source. the ultimate goal of a truly regional disease program is to control and eliminate dog-mediated rabies and protect and maintain rabies-free areas in asia. current regional efforts aim to strengthen the intercountry coordination, and technical and institutional capacities to manage dog rabies elimination programs. the regional and national implementation efforts provide strategic direction and cooperation to ensure successful implementation of rabies control measures and eventual elimination. the focus areas include human rabies prevention through pre- and postexposure prophylaxis, mass dog vaccination, surveillance and epidemiology, laboratory diagnostic capability, public awareness and risk communication, legislation, dog population management, and establishment and protection of rabies-free zones/areas. existing mechanisms for implementation, when applied, give emphasis on one health collaborations. areas. existing mechanisms for implementation, when applied, give emphasis on one health collaborations. for most countries in asia, canine rabies is endemic and the majority of human rabies exposure results from dog bites particularly among children. the estimated number of human deaths across asia and africa is approximately , , with over . million disability-adjusted life years (dalys) and . billion usd economic losses annually [ ] . the vast majority of these deaths is in asia ( . %). india, with % of human rabies deaths, accounted for more deaths than any other country. rabies is often neglected when health and agriculture (animal health) agenda and budgets are set even if the costs and economic benefits have long been described [ , ] . it continues to be neglected and very often its public health impact is minimized by other priority infectious diseases like dengue, malaria, tuberculosis, and hiv. reliable data indicating the actual incidence of human rabies and rabies risk exposures are often lacking or non-existent in many countries, leading to the global number of human deaths that is significantly underreported [ ] [ ] [ ] . canine rabies is not only a major burden in endemic countries where thousands of human deaths occur annually, but also in previously rabies-free areas where risks of re-emergence have been increasing over the last decade [ ] [ ] [ ] [ ] [ ] . the burden of canine rabies is substantial, even though the disease is entirely preventable. dealing effectively with the problem is contingent on investing in the control at the animal source, which has long been lacking. long-term mass dog vaccination with high enough coverage could reduce health sector and societal costs with more rational and judicious use of postexposure vaccination [ , ] . disease elimination is feasible with currently available vaccines and disease control methods; however, innovative financing models are required to overcome institutional barriers. in , the first who interregional consultation on strategies for the control and elimination of rabies in asia laid down the impetus for many asian countries to promote and pursue the elimination of canine rabies to eventually eliminate the disease in human populations [ ] . asian countries were urged to develop comprehensive national plans with improved access to modern human vaccines and application of new economical postexposure treatments, better disease diagnosis and surveillance, and processing of data at the national, regional, and global levels, intersectoral collaborative efforts for dog rabies control and plans to expand public and health care worker awareness regarding rabies control and prevention. the association of southeast asian nations asean call for action toward the elimination of rabies in the asean member states and the plus three countries (china, japan, and korea) by demonstrated the key importance attached to rabies control at a political level [ ] . the asean rabies elimination strategy (ares) was developed in to provide a strategic framework for the reduction and ultimate eradication of canine rabies in asean member states. the strategy describes an integrated one health approach that brings together the necessary sociocultural, technical, organizational, and political pillars to address this challenge. the ares was designed to complement the existing subregional frameworks developed to control and eliminate human rabies, such as those developed by the asean expert group on communicable diseases (aegcd) in . in south asia, considering the importance of consolidating achievements in rabies control in member countries, the who regional office for southeast asia has developed a regional strategy for elimination of human rabies transmitted by dogs ( ) [ ] . in the middle east and central asia, human cases still occur, and dogs are the main vector. these regions plus countries of north africa and europe, belong to the middle east and eastern europe rabies expert bureau (meereb), an interregional rabies prevention and control network. in , meereb has called for elimination of dog-transmitted rabies through vaccine and rabies immunoglobulin stockpiles and implementation of a one health approach to achieve rabies eradication [ ] . across the continent, there is a marked increase in community-based initiatives for domestic animal vaccination and control with increased government support to funding and better program implementation. animal rabies control activities vary across the region [ ] [ ] [ ] [ ] . many national and subnational programs and demonstration projects have proven that proactive mass dog vaccination is much more effective at controlling rabies and less costly than campaigns that vaccinate in response to the occurrence of cases. control through proactive vaccination followed by two years of continuous monitoring and vaccination should be sufficient to guarantee elimination from any area not subject to repeat introductions [ ] . the degree of success of national and global canine rabies elimination efforts, however, depend heavily on effective epidemiological surveillance, which should ensure that intervention impacts can be monitored through time and outbreak responses initiated where necessary. it is recommended that rabies control programs ought to be able to maintain surveillance levels that detect at least % (and ideally %) of all cases to improve their prospects of eliminating rabies, and this can be achieved through greater intersectoral collaboration [ ] . rabies is a community-based problem that requires a well-organized and funded community-based approach. many countries need to strengthen their communitybased programs and implementation platforms, especially where government lacks the capacity and effective governance to mobilize community efforts [ , ] . in these settings, well-organized community efforts that aim to support or augment existing government rabies elimination programs are much desired. in countries such as indonesia, philippines, sri lanka, and thailand, these are often facilitated by nongovernment organizations and civil society organizations closely coordinating with the local government and private sector groups. there are practical bottom-up approaches that can be appreciated by governments. effective community-based approach seeks to strengthen the capacity of families, individuals, organizations, institutions, and systems to support disease programs and outbreak responses. it is expected to contribute in programming to reduce rabies risk and address community vulnerabilities, and enhance community and institutional resilience, being sensitive to the issues directly confronting communities, and desiring to support families and all sectors involved (whole-ofsociety) to take the necessary actions to reduce dog bites and rabies transmission risks. working through the lowest unit of a community, the family or household unit, is central, as "more resilient families are the foundation of more resilient communities." individual family units should be fully aware of rabies threats and the required interventions and be the first to take action when these threats appear, such as reporting dog bite incidents to community leaders. the ability of a nation to eliminate rabies starts at household levels-with family members understanding the risks of rabies and being able to systematically mitigate spread, and therefore ensure neighborhood rabies security. fostering private sector commitment to building and empowering communities through their corporate and human resource is another key element to effective community efforts. an integrated approach is the most effective way of protecting humans from canine rabies, as the infection is maintained in domestic dog populations [ ] . a number of countries have achieved considerable success in canine rabies elimination through mass dog vaccination. the feasibility and cost effectiveness of this approach have been strongly advocated in recent years, with major international public and animal health organizations declaring global canine rabies elimination as a realistic goal. significant progress in the production of rabies vaccines for human use that are low cost, rapidly immunogenic, safe and practical to use has led to increasing accessibility to timely and appropriate pep. in the early s, thailand pioneered the pep intradermal (id) regimens using cell culture-derived vaccines [ ] . from the time it was endorsed by who in , accessibility further improved due to increase in numbers of animal bite management centers, and better quality of services [ , ] . this eventually eased out the production of mammalian nerve tissuederived vaccines. in the philippines and sri lanka, since mid- s, animal bite treatment centers were established in government hospitals and major health facilities [ , ] . minimum essentials include training for mds and nurses in the proper management of patients and rabies exposures, cold chain, and systematic recordkeeping or registry. to date, id regimens are the first line in majority of the national rabies prophylaxis protocols and recommendations. rabies immunoglobulin of equine origin (erig) are in short supply throughout the world and particularly in asia, the demand is high [ ] . erig available in asia is either manufactured in europe, india, or china. though erig is considerably cheaper than human origin immune globulin, modern production of immune sera generates highly purified and safer products of better quality. producers of erig should be encouraged to continuously aim for consistent antibody levels and the least incidence of adverse reactions among patients. current recommendations for pre-exposure schedule use id injections of cell culture vaccines as a cost-reducing alternative for developing countries. as a strategy to augment human rabies prevention measures, childhood rabies immunization has been included in the national programs of countries like the philippines and vietnam. human vaccine production capacities of asian countries have improved greatly. rabies vaccine supplies come from a mix of private and public manufacturers in several asian counties and are mainly for domestic use, but some manufacturers have the potential to export vaccines. over the last decade, both private and public vaccine manufacturers in asia have exerted extra efforts to meet stricter government registration requirements as countries adhere to international and regional gmp (good manufacturing practice) standards and vie for who pre-qualification. the national regulatory authority (nra) in most countries generally enforces their local gmp standards, which tend to be stricter and more demanding to the producers [ ] . the procedure for approval of newly introduced vaccines is very much in place, involving the conduct of complete preclinical and clinical testing and establishing lot consistency prior to approval for marketing. most countries have functional nras/national control laboratories (ncls), which provide overall control on the vaccine production process and final product quality. exceptionally, a few countries still lack the capacity to perform rigid laboratory testing. demand and supply human rabies vaccine manufacturers are growing in number most markedly in china and india with more than manufacturers serving a combined population of more than billion with an estimated demand for rabies vaccines of about million doses or about million full-course treatments per year. the vaccine production levels typically range from , doses to million doses per year (for cell-based production facilities), with some producers in china and india upgrading their capacities to produce more [ ] . vaccine types china and india discontinued the production of mammalian nerve tissue origin (nto) vaccines in , and vietnam stopped producing the sucklingmouse brain vaccine, which has been in use over years, in [ ] . it now imports cell line-based vaccines, and they have also modernized their main vaccine manufacturing plant (gmp compliant) located in hanoi. all these manufacturers follow the who standard requirements, as well as refer to usp requirements. there are essentially types of modern vaccines, according to the substrate, that are produced mainly in china and india, namely the primary hamster kidney (phk) cell, vero cell, human diploid cell (mrc- ), embryonated duck egg, and chick embryo cell. of these, the vero cell is the only continuous (animal) cell line. all these vaccine types undergo concentration and purification processes by either zonal centrifugation or tangential filtration and gel chromatography. the virus strains being used include the pv (pasteur institute paris or cdc) and pm (wistar institute), and in china they also use their locally derived strains. vaccine preparations are either liquid or freeze-dried single dose ( . or . ml) in glass vials and are administered according to the essen regimen [ ] . quality asian vaccine manufacturers generally apply in-process control measures that include sterility tests, elisa, srd, and nih potency testing. national regulatory authorities only issue marketing licenses if complete testing of vaccines, including preclinical and clinical studies, has been conducted. laboratory testing regimens applied essentially follow who requirements, and lot release systems are being constantly reviewed and modified. in china, a system of random testing of production lots and post-market surveillance/testing and product recall are being strictly put in place. random lot testing generally includes tests for sterility, safety, and potency (nih method). most rabies vaccine manufacturers (public and private) seek to be who pre-qualified as they consider it advantageous to the marketing and worldwide distribution of their products [ ] . costs in china and india, the cost of modern locally produced vaccines range from to usd per dose. in china, imported vaccines are - usd per dose. in southeast asia, imported vaccines typically range from to usd per dose. hold backs and the way forward some countries that intend to start their local modern rabies vaccine production need support to establish cell line-based vaccine production, such as seed virus, cells, technology transfer, and funding for equipment or facilities. as who prequalification is sought for rabies vaccines, manufacturers observe that the process takes too long. as more new manufacturers join in, the demand for training of personnel on gmp must be addressed by all stakeholders. the reliability of the currently prescribed nih potency test is a major problem that manufacturers face in the production and control of rabies vaccines. essentially the nih test gives varying results depending on the laboratory and the status of the mice which the test utilizes. some manufacturers have also questioned the need to conduct the stability testing of vaccines on a per batch basis [ ] . in general, countries are able to follow the who requirements for human rabies vaccine production. the complete replacement of nto vaccine with cell line-based rabies vaccines has been accelerated, as india and china have demonstrated the feasibility of domestic commercial vaccine production. countries generally have the desire to produce better quality vaccines but are concerned about the effect on supply, and how to get the production of cell line-based vaccines started. regional supplies of relatively inexpensive vaccines will surely influence the decisions of countries to produce their own cell line-based vaccines. it would be advantageous to countries if who introduced a system of recognizing (qualifying) domestically produced vaccines using various types of cell substrate, and encourage exports where appropriate, principally to lower the world price of human rabies vaccines. to increase awareness and enhance community participation and support, public information and education are necessary. components of the information campaign generally have discussions on rabies as a fatal disease, its epidemiology, and its prevention and control, the disease control program in general and related national and local rabies ordinances as they support the program implementation and responsible pet ownership. with the realization of the impact of rabies in daily lives, and that pets can be a source of human infection, implementing community and schoolbased programs were relatively easy to roll out. volunteerism, active engagement, and willingness to pay of people in the program stems likewise from communitybased initiatives [ ] . community-based programs found all over asia concentrate on campaigns using multimedia (television, radio, newspapers, internet/mobile devices), display of posters and banners in strategic areas, distribution of flyers and other materials, public hearings of local ordinances and hosting of village assemblies. some educational campaigns are often conducted at various government offices and in churches or other religious structures. generally, celebrations like the world rabies day are observed to remind people of the continual threat of rabies and the importance of the program to control and eliminate the disease. school-based rabies educational programs, designed to improve awareness about rabies prevention among children are common in countries like india, philippines, thailand, and vietnam. these were mostly developed and are implemented with the ministry of education and in coordination with the ministries of health and agriculture. in the philippines, the integration of rabies education into the school curriculum was initially developed by the department of health's national rabies control program in [ ] . lesson plans prepared by school teachers integrated facts and figures about rabies, and lessons on responsible pet ownership. activities for the children involve fun educational events to celebrate the bond between children and pets. the power of the youth must be harnessed. lessons taught in interactive school programs could be brought into households and be ingrained in family values. rabies awareness in youth and adolescents will ripple through the entire family unit, thereby ensuring sustainable rabies interventions in future generations. the youth can proactively be involved in dog vaccination and control. governments that are committed to implementing disease control programs provide the institutional framework, legislation and policies, infrastructure and logistics, human resources, and budget appropriation. the legal framework for implementing rabies prevention and control programs is already in place in most countries in asia. national legislation defines the roles and responsibilities of the councils including dog and dog owner registration; collection of registration fees; animal population control; dog vaccination; surveillance of human and animal rabies and exposures; settlement of disputes/agreements between bite victims and dog owners; and promotion of responsible dog ownership. funds for disease control programs are traditionally sourced from local and national governments, and international development aid. actual implementation of intersectoral rabies control programs often requires and depends on regular budget allocation as mandated by law. international aid agencies and nonprofit organizations offer funding and technical inputs, pooling of resources, set guidelines, and standards, have monitoring and evaluation mechanisms and often act as an intermediary between donors and government. in any disease control program, wide stakeholders' involvement is critical [ ] . it is important to bring together key stakeholders from business and the public sector to discuss health security and the importance of establishing public-private partnerships. contributions from private organizations, including businesses, academe, and civil society, can be tangible and intangible. tangible efforts are generally in the form of donations in kind or money. intangibles such as voluntary efforts should be maximized. the intense involvement of the local communities has served as a conduit for business sectors, nongovernment organizations, academic institutions, and civil society organizations to extend their financial and technical assistance to the government. the national government agencies can sustain the standardized approaches to rabies control and elimination and promote how to start the public-private partnership that would ensure sustained intervention. such technical and administrative conduits are essential and beneficial to all stakeholders, providing the credibility and quality assurance that is directly rooted in the day-today field operations. there are numerous examples of public-private partnerships that contribute to public program implementations, support research and promote policy development in bali, indonesia, india, sri lanka, philippines, thailand, and vietnam [ ] . a number of rabies control programs in humans and animals have sourced funds from different sectors at different levels. the range of sources could be from the grassroots to the corporate and people's organizations. general support to local governments given by partner organizations includes community mobilization, volunteer services, and materials donations. the business sector gives direct donations or embarks in joint ventures. the academe conducts research and offers technical inputs, voluntary services, and student manpower. the community contributes taxes, fees for service, donations, and volunteer manpower. field implementers and partner communities often face constraints such as high operational cost, wide regions of coverage and labor intensity. many innovative approaches have been attempted to overcome these problems. there are numerous lessons of good practices learnt from experience. an example of a successful, sustainable community-based integrated rabies control program is the bohol rabies elimination program, implemented as a partnership between the provincial government, the national government line agencies (health, agriculture, education, interior, and local government) and a few nonprofit organizations. the project brought together educators, physicians, veterinarians, government officials, community leaders and the general public, and aligned them for coordinated effort [ ] . this program produced a significant shift in rabies control, from government-dependent implementation to a community-led movement. collateral benefits included better conditions for animal welfare, more responsible pet ownership, and improved public safety. ownership of the program at the community level has assured more engaged field operations and sustainability. attaining the goal of rabies control and eventual freedom from disease became a shared concern. there are challenges though to public-private partnerships. the continued assurance of private-sourced funds depends on the effort to acquire these; thus, fund sourcing must be a full-time effort that requires a wide range of committed stakeholders. the credibility that has been established through successful local programs facilitates fund sourcing. field experience showed that there could be disincentives to provision of external assistance including an uncertain political environment, lack of political support, and inadequate counterpart funds [ , ] . the key to the success of a public-private partnership model is the strategic partnership among the community-based stakeholders with sound technical and operational capabilities to implement the rabies control and elimination program framework and strategic plan. the partnership ensures evidence-based and informed program planning, institutionalized organization, policies, and implementation mechanisms, the setting in place of clear performance indicators, and uninterrupted resource inputs. the key steps in project integration within the local system is the identification of key persons or technical and political champions, clear and functional feedback channels among partners (e.g., internal and external monitoring), and encouraging government empowerment and program ownership, stakeholder participation and formally defining roles and responsibilities of stakeholders through memoranda of understanding. increased public awareness and understanding enhance willingness to pay and contribute for public good. program sustainability is a critically important issue for all public health programs, but especially for resource-poor countries with limited budgets and many problems to resolve. thus, a successful rabies prevention and control program must be built around integration and the strengthening of intersectoral and transdisciplinary collaboration and cooperation between several societal components [ , , ] . the asean rabies elimination strategy gives particular importance to the organizational and one health framework for rabies elimination [ ] . as an example to understand better, the expansiveness of one health challenges: in dealing with urban rabies threats, it is recognized that the best single approach is to attack the disease at its source, that is, to eliminate dog-mediated rabies. eliminating dog rabies greatly reduces the need for postexposure human prophylaxis, at least at some point in time if the process is executed systematically. in this regard, the health sector has been at the forefront of rabies elimination programs. while this traditional principle of rabies elimination is proven to be one of the most well-based and sound of disease control strategies, in reality program implementations are confounded with complexities, resulting in more failures than successes (with only a few established and emerging exemptions). the failures have often been associated with the re-emergence of rabies after it had been temporarily eliminated in the dog population. even areas (e.g., islands) once rabies-free have encountered emergence and endemic spread of urban rabies [ ] [ ] [ ] . this has been the general situation for many decades. while the prescribed solution is sound and tested, i.e., elimination of rabies at-source, in the overall process, whole-of-society must deal with the complexities of prevailing urban rabies. detailed scientific argument is not necessary to point out that poverty is a strong driver of rabies endemicity. for example, the massive proliferation of slum areas is directly proportional to rabies proliferation. the survival priorities of people dictate their health and wellbeing-seeking behaviors; obviously, food and shelter come first to those who are hungry and cold. in the same way, hungry stray dogs seek food and shelter, and the proliferations of garbage and market wastes drive these behaviors. populations, whose general health and wellbeing are deteriorating, will be further drawn into the state of poverty. where there are people who (must) eat dogs, there will be those who propagate and market dogs legally or illegally. there are a number of undesirable reasons why dogs are able to cross boundaries and islands. and there will always be bad governance that reciprocate bad community participation/cooperation. such complexities are too numerous to mention all here but are at the heart of why programs fail. very similar arguments also apply to the continued proliferation and emergence of other infectious diseases [ ] . most significantly, poverty dynamics clearly drive vulnerabilities to diseases [ ] [ ] [ ] , and these include ( ) lack of adequate safe food and water; ( ) lack of protection from harm such as exposure to pests, inclement weather, pollution, violence, stress, and disasters; ( ) extreme social marginalization and deprivation of opportunities to earn a living, to be educated, to receive healthcare; and ( ) infliction of collateral harm, especially to woman and children, the disabled and the elderly. clearly, the determinants of infectious diseases are multifaceted and increasingly complex [ ] . poverty reduction is central, as generally, poverty alleviation means vulnerability reduction. this has been documented in relation to the likelihood of infectious diseases emergence in impoverished community settings [ ] . good governance, involving the highest inter-ministerial central body for one health coordination backed up by legislation and a clear mandate, budget appropriation, resources mobilization, and pilots or model programs that lead to policy development, provide optimism to implementing comprehensive operational plans that are vertical and horizontal, national and sub-national. these are important institutional drivers and enablers for a sustainable public-private partnership. comprehensive rabies control programs should consider combining human, financial, and material resources with other interdisciplinary disease programs to benefit from synergy and maximization of shared resources. with the guidance of oie, fao, and who, governments, donors, foundations, and other private partners should be mobilized to sustain investment in canine rabies control and eventual elimination. pursuing the regional goal of rabies elimination cannot be taken lightly. sustained investment mechanism and integrative efforts must be enabled, for instance, by the designation of a specifically mandated body, e.g., a rabies or one health authority directly under the office of the president or prime minister. such body could be assigned a czar (secretary or minister level) and a dedicated budget for office and resources. it should be solely focused on rabies elimination (in the meantime), and collaborate as necessary with the health, veterinary, education, environment, industry, and other sectors on clearly defined parameters and terms, with its authority maintained at all levels, i.e., national to local. the structure and mechanism for this could be legislated. such legislation, together with the creation of the one health authority, will remain relevant to the continuous prevention, control, and eradication of any zoonoses threat (e.g., ebola, influenza, sars, mers-cov, malaria, leptospirosis) that potentially are pandemic threats. it is important to recognize the main justification for these radical recommendations which is: any country with a prevailing human rabies threat in this modern and highly connected world is considered a hindrance to global progress. all stakeholders are specifically drawn to the enhancement of governance. this is to ensure a sustainable approach to comprehensive capacity strengthening and broader risk reduction in the context of community resilience and regional security. the overriding objective is to advocate for continued and better targeted funding to strengthen capacities to immediately and effectively detect, prevent, and prepare for and respond to any infectious disease/zoonosis outbreaks and similar major threats. targeted initiatives must promote broad resilience objectives, cognizant that absolute efficiency of systems, especially in relation to widespread threats, is contingent on the interdependencies of sectoral and systems approaches, and the capacity to enable strategic systems synergies. whole-of-government/whole-of-society coordination, involving multi-sectors within communities, is key. therefore, rabies and zoonoses preparedness needs to be integrated into emergency and crisis response systems. the systematic involvement of even the military should be pursued. the one health authority's core structure, functions, and capacities to plan, prepare, mitigate risk, and respond to threats through its dedicated rapid response teams should be sustainable. these must integrate into the broader whole-of-society platform and proposed "one resilience" approach [ ] to effective interactions among national and regional entities involved in the prevention and control of rabies and other zoonoses (depicted in fig. ) , to the extent that all actors understand their roles and are enabled to effectively respond when major threats strike, so that normal operations, economic activities, and livelihood are protected and sustained. estimating the global burden of endemic canine rabies rabies control in the republic of philippines: benefits and costs of elimination re-evaluating the burden of rabies in africa and asia review of rabies epidemiology and control in south, south east and east asia: past, present and prospects for elimination basel: karger surveillance guidelines for disease elimination: a case study of canine rabies the rabies epidemic on flores island, indonesia ( - ) re-emergence of rabies in dogs and other domestic animals in eastern bhutan epidemiological and clinical features of human rabies cases in bali history of rabies control in taiwan and china one health: the theory and practice of integrated health approaches. wallingford: cabi towards canine rabies elimination in cebu, philippines: assessment of health economic data strategies for the control and elimination of rabies in asia oie world organisation for animal health, oie sub-regional representation for south-east asia (oie srr-sea). . asean rabies elimination strategy strategic framework for elimination of human rabies transmitted by dogs in the south-east asia region meereb report of the third meeting of the middle east and eastern europe rabies expert bureau inferior rabies vaccine quality and low immunization coverage in dogs (canis familiaris) in china who. who expert consultation on rabies: second report. who technical report series no. towards the elimination of rabies in eurasia: joint oie/who/eu international conference report of a who consultation on intradermal applications of human rabies vaccines rabies vaccines: who position paper willingness to pay for dog rabies vaccine and registration in ilocos norte implementation of an intersectoral program to eliminate human and canine rabies: the bohol rabies prevention and elimination project renewed global partnerships and redesigned roadmaps for rabies prevention and control integrative societal resilience or 'one resilience' approach: towards optimal health and wellbeing infections and inequalities: the modern plagues sustained global attention to emerging pandemic threats and risks: the need to strengthen one health systems and whole-of-society preparedness global report for research on infectious diseases of poverty. special programme for research and training in tropical diseases social determinants of infectious diseases in south asia ochungo p mapping of poverty and likely zoonoses hotspots. dfid zoonoses report biosecurity within one resilience. paper presented at the asean regional forum (arf) cross-sectoral security cooperation on bio-preparedness and disaster response workshop key: cord- -hrb vt authors: hipgrave, david; mu, yan title: health system in china date: - - journal: health services evaluation doi: . / - - - - _ sha: doc_id: cord_uid: hrb vt the health of china’s population improved dramatically during the first years of the people’s republic, established in . by the mid- s, china was already undergoing the epidemiologic transition, years ahead of other nations of similar economic status, and by , life expectancy ( years) exceeded that of most similarly low-income nations by years. almost years later, china’s health reforms were a response to deep inequity in access to affordable, quality healthcare resulting from three decades of marketization, including de facto privatization of the health sector, along with decentralized accountability and, to a large degree, financing of public health services. the reforms are built on earlier, equity-enhancing initiatives, particularly the reintroduction of social health insurance since , and are planned to continue until , with gradual achievement of overarching objectives on universal and equitable access to health services. the second phase of reform commenced in early . china’s health reforms remain encouragingly specific but not prescriptive on strategy; set in the decentralized governance structure, they avoid the issue of reliance on local government support for the national equity objective, leaving the detailed design of health service financing, human resource distribution and accountability, essential drug lists and application of clinical care pathways, etc. to local health authorities answerable to local government, not the ministry of health. community engagement in government processes, including in provision of healthcare, remains limited. this chapter uses the documentation and literature on health reform in china to provide a comprehensive overview of the current situation of the health sector and its reform in the people’s republic. the health of china's population improved dramatically during the first years of the people 's republic, established in . by the mid- s, china was already undergoing the epidemiologic transition, years ahead of other nations of similar economic status, and by , life expectancy ( years) exceeded that of most similarly low-income nations by years. almost years later, china's health reforms were a response to deep inequity in access to affordable, quality healthcare resulting from three decades of marketization, including de facto privatization of the health sector, along with decentralized accountability and, to a large degree, financing of public health services. the reforms are built on earlier, equity-enhancing initiatives, particularly the reintroduction of social health insurance since , and are planned to continue until , with gradual achievement of overarching objectives on universal and equitable access to health services. the second phase of reform commenced in early . china's health reforms remain encouragingly specific but not prescriptive on strategy; set in the decentralized governance structure, they avoid the issue of reliance on local government support for the national equity objective, leaving the detailed design of health service financing, human resource distribution and accountability, essential drug lists and application of clinical care pathways, etc. to local health authorities answerable to local government, not the ministry of health. community engagement in government processes, including in provision of healthcare, remains limited. this chapter uses the documentation and literature on health reform in china to provide a comprehensive overview of the current situation of the health sector and its reform in the people's republic. most people are familiar with two things about modern china. the first is its physical size and enormous population. in land area, china is the world's third largest nation, theoretically spanning h of time difference from west to east (while officially operating on one time zone). its census revealed a population approaching . billion, the world's largest. china's population grew most rapidly from the late s to the early s, due to the formerly high fecundity of its women alongside a rapid fall in the crude death rate due to communicable disease control (cdc) and basic public health measures. life expectancy also rose rapidly during this period ( fig. ) (hipgrave a ). the second familiar aspect is china's meteoric economic development, with an average annual growth rate of around % for most of the last years, only falling to - % since the global financial crisis. these familiar aspects of china have depended on the health of its population improving dramatically during the first years of the people's republic of china (prc) since its establishment in . by the mid- s, china was already undergoing the epidemiologic transition, years ahead of other nations of similar economic status, and by , life expectancy in low-income china ( years) exceeded that of most similarly low-income nations by years (jamison et al. ) . however, with cdc (hipgrave a), economic development, rapid urbanization, and a dramatically ageing population, china's health system now faces a vastly different range of issues. china will soon become the first large nation to age before achieving developed nation status. noncommunicable diseases (ncds) now account for over % of deaths in china and almost % of its total disease burden (the world bank human development unit ). a world bank analysis of ncds in china (the world bank human development unit ) concluded that "a reduced ratio of healthy workers to sicker, older dependents will certainly increase the odds of a future economic slowdown and pose a significant social challenge in china" (page ). equally challenging is the provision of new services for the prevention and management of chronic illness and the government's averred commitment to equity and universal health coverage. these challenges and commitments were among the stimuli to the major health system reform (hsr) that china commenced in (state council ). china's most recent hsr was a response to deep inequity resulting from three decades of marketization and de facto privatization of the health sector. it was the culmination of many years of debate (tang et al. a ) after acknowledged inaction on the heavy burden of healthcare on household expenditure (blumenthal and hsiao ; huang ; liu ; liu et al. ; tang et al. ) . it comprises initiatives in five main areas: . expanding the coverage and benefit of health insurance schemes in urban and rural areas . establishing a national essential medicines scheme to ensure the availability of affordable medicines and reduce the ability of health providers to profit from the sale of drugs . improving basic service availability and quality while also reducing referrals to specialist care and hospitals . ensuring the availability of basic public health services for all populations . piloting public hospital reform, particularly in order to separate hospital management and clinical service provision the current hsr builds on earlier, equityenhancing initiatives including the reestablishment of rural health insurance (meng et al. ) and subsidized hospital maternity services (feng et al. a) . early progress on the first phase of china's current hsr ( was extensively reviewed, both internally by domestically commissioned teams of international (unpublished) and national experts (wu and yang ; li and chen ) and externally (yip et al. ). the reform is planned to continue to , with gradual achievement of its overarching objectives on universal and equitable access to health services; the second phase ( - ) was announced in early (ministry of health a), and a major additional pronouncement on county hospital reform was made in early (state council ). monitoring and evaluation of the reform is slated to prioritize its different hierarchical elements (figs. and ), although detailed plans for such evaluation have not been released. china's commitment to hsr indicates its ongoing priority for the highest echelons of government (ministry of health a). the four-year plan for phase reiterates the goal of universal access to basic health services and seeks to resolve constraints to the supply of china's increasing and diverse health needs. it again commits to expanding insurance benefits and introduces priority to unifying china's several health insurance schemes; it encourages development of commercial insurance and the introduction of capitation and other payment reforms to separate doctors from the financial management of hospitals; it suggests that the private sector should manage % of health services by ; family general practice is promoted alongside expanding community and public health services, and the drug production, prescription, and pricing will be further consolidated and regulated; performancebased funding of health staff is also mentioned. these individual areas are discussed further below. the plan is encouragingly specific but not prescriptive on strategy and avoids the issue of local accountability for financing various health programs, stipulating only that government spending on health should gradually increase as a proportion of total government expenditure. this vagueness hints at a major problem for china's health sector, the reliance on local government support for the national equity objective . another major problem remains the difficulty of reforming hospital management, effectively undoing the private, for-profit system that evolved over recent decades. as a result, china's hsr has not yet reduced the proportional financial burden of healthcare on households or their risk of catastrophic expenditure on health (meng et al. ). organization of the health system china's former ministry of health (moh) recently merged with the body previously responsible for family planning to form the national health and family planning commission (nhfpc). the commission contains different departments, offices, and bureaux responsible for setting standards and for the planning, administration, oversight, and reporting on china's health sector. however, as with most of china's social sectors, there is a heavy decentralization of responsibility for local planning, financing, and implementation of health services in china (wong ; zhou a) . in china's decentralized system, policies and reform guidelines are set at national level but implementation is delegated to local authorities at provincial and lower levels. a hierarchy of health authorities oversees these issues at province, prefecture, county, and township levels. in china's political economy and governance structure, local health authorities are more responsive to local government than to higher-level cadres within the health sector, meaning that uptake of national policies and recommendations is only guaranteed if there is broad agreement across all sectors of government and at local government level. in the past, when the health sector was of low priority, this severely limited the implementation of national laws relevant to the health sector. for example, the law on control of infectious diseases conferred on local government's responsibility for various forms of reporting and action, but was weakly implemented, culminating in the wake-up call of sars in , redrafting of the law and major reform of cdc (hipgrave a; wang et al. a) . initiatives depending on countrywide uptake such as the national measles vaccination campaign still rely heavily on local funding and prioritization; recent environmental degradation and food and drug safety scandals are further evidence of the lack of cross-sectoral priority given to the health sector in china. the partial rollback of the one-child policy announced at national level in remains subject to interpretation and optional implementation by provincial governments. despite its evident high priority (tang et al. a ), many aspects of the hsr itself are dependent on the same support and follow-up by provincial and even county governments brixi et al. ) . to ensure that hsr would receive adequate local priority despite this structure and accountability, in early the hsr leading group in the state council signed "accountability contracts" with provinces on key reform areas, for subsequent delegation and implementation at lower levels (china news network ). in some provinces, a few key hsr targets such as health insurance coverage were incorporated into subnational officials' performance evaluation criteria, which has been effective in ensuring progress. however, in other, more complicated reform areas, such as strengthening primary healthcare, public hospital reforms, and others, ensuring progress has been more difficult. indeed, the reform of public hospitals suffers from a lack of consensus or clear national guidance on direction, limiting its prioritization and implementation outside pilot areas, particularly at low levels. figure illustrates the ideal accountability relationships among government, healthcare providers, and citizens (society) in the delivery of healthcare. however in china, such relationships have not yet been forged. while there are promising moves to make local government generally more accountable to the public (such as measurement of "green gross domestic product (gdp)" and independent surveys of public opinion on local government performance in some provinces), the main motivation for subnational authorities remains economic development and revenue generation (zhou b) . moreover, while banking, communications, etc. are carefully regulated and monitored from above, like most social sectors, health services are largely organized and monitored at the local level. it is too costly for china's undermanned central government to independently monitor and evaluate subnational health performance (wong ; zhou b) . these circumstances explain the limited ability of national health officials to ensure the hsr is fully pursued at grassroots level. in theory, all government plans represent the will of the people as they are ratified by the national people's congress. however, many congress members are unelected (in the western democratic sense) appointees, and the people's congress generally rubber-stamps the documents presented. however, with the increasing attention of the party and government in china to public comment through social media, albeit increasingly censored (osnos ) , and local protests, there is growing acknowledgment of their answerability to the general public. therefore, while during local planning there is almost no formal process for the public to make input, there are opportunities for the general population to voice concerns through the courts, social media, petitions, protests, etc., especially when issues affect a significant proportion of a community. although the process is usually slow (the hsr took many years to be formalized (tang et al. a )), there is usually gradual recognition and acknowledgment of the need to act. on the other hand, implementation of plans usually requires higher-level pressure on the various lower tiers of government, and this pressure progressively dissipates further down the hierarchy; it may be ignored for issues that don't have high-level and cross-sectoral support and the support of local government. hence, targets for insurance coverage and drug price control are accepted, but controlling the environmental impact of local industry is often ignored (human rights watch ). in this process, public influence is rather indirect and can be ignored if local economic, political, or vested interests override it. patients' concerns in healthcare delivery may be channeled formally through the national people's congress at different levels (although usually only major complaints reach this level) or informally through social media. however, mechanisms to tap the feedback of patients, as the end users of health services, have not been established. there is no ombudsman or independent regulator in china's health system, and senior appointments are normally approved by the ruling party organization. however, since launching the hsr, government is learning that empowering patients and regularly collecting their feedback on key parameters such as service prices and quality strengthens accountability across the government levels and can help achieve the overall goals of the reform (state council ). patient satisfaction and feedback is increasingly incorporated into the performance evaluation framework for hsr implementation (ma ) . however, this practice has not yet been standardized, systematized, and regularized throughout china. an example of the problem china is having in effecting the most difficult aspect of the hsr, the reform of public hospitals, was recently summarized by eminent researchers on china (yip et al. ) , who noted the complex web of relationships that govern this endeavor (fig. yip et al. ) to make progress in this area of reform, although some commentators doubt this will be achieved in the current context (zhang and navarro as part of the government's regular planning, the new npfpc drafts annual national health work plans with annual targets and submits annual budget proposals for approval by the ministry of finance and the ndrc, which approves major construction initiatives such as health infrastructure development. with major events as the hsr, new changes and innovations are often seen in the plans year on year. at subnational levels, healthrelated authorities (not only health bureaux) in provinces, prefectures, and counties submit annual planning and budget proposals in line with health service delivery needs and stewardship to the development planning and finance authorities at the corresponding tier. implementation is financed by local budget supplemented by transfers from higher tiers of government (explained below). local data should be used in formulating plans, but as there is little tradition of regular, independent, or audited data gathering in china, desensitization of administrative and economic data is suspected (cai ; hu et al. ; walter and howie ; kaiman ; anonymous ) . regulation of the health sector follows the accountability structure outlined above and appraises progress and achievement against high-level targets set at national and local levels. performance assessment tends to be quantitative (relating to coverage or throughput of health services), although assessment on more subtle measures such as patient satisfaction, service quality, and disease management has commenced (as outlined in a guidance on performance assessment of basic public health services delivery, jointly promulgated by ministry of health and ministry of finance in january ). at management level, government officials are also increasingly being appraised according to efficiency and innovations in rolling out reform initiatives at local level. with around % of the world's people, population-level changes in china's health status or indeed any globally important indicator have a major influence on corresponding global progress. for example, china's progress toward regional and global achievement of the millennium development goal (mdg) targets will impact any final evaluation of the mdgs in . however, global statistics in any of the biological, physical, and social sciences can only be calculated if china's data is included and considered to be reasonably accurate, and data from china is not always available. many lists of global indicators lack an entry from china, and the accuracy of what is released has been questioned (cai ; mulholland and temple ) . usually, this is simply because china itself does not collect national statistics on the relevant indicators or not in ways comparable with other nations (e.g., see http://www.countdown mnch.org/documents/ report/ / _china.pdf). however, as long ago as , perspectives on china's mortality data were quite positive (banister and hill ) . the overall lack of data from china rouses suspicion. but while china's official statistics often lack breakdowns on key indicators (e.g., until recently, child mortality by gender or cause of death; nutrition status by province) or vary widely from one official source to the next (such as the annual birth cohort (cai ) or number of road deaths (hu et al. ) ), these issues distract from china's efforts to improve the content, frequency, quality, and public availability of official data in recent decades (banister and hill ) . indeed, unicef's "atlas on children in china" publishes a wide range of official and recent data (http://www.unicefchina.org/ en/index.php?m=content&c=index&a=lists& catid= ), and health statistics and other yearbooks are published annually (ministry of health b; national bureau of statistics , ) with a great degree of detail and disaggregation. an increasing number of official and peerreviewed publications on maternal and child health (mch) in china report official government data (wang et al. rudan et al. ; ministry of health a; feng et al. b feng et al. , , and this is contributing to summaries of global progress on the world's health status and mdgs and . china relies on several different sources to provide health administrators, the public and academia with information on the health sector. while it has never conducted a demographic and health survey, and its last multi-indicator cluster survey was in , china's national health services survey has been undertaken with a reasonably consistent methodology on a five-yearly basis since . many publications have used this source to assess progress in aspects of china's health system (meng et al. ) and on its health indicators . as an example of the other sources used, china's official mch management information system (mis) and the china health statistics yearbook (ministry of health b) rely on data from the following: . mch annual reports: administrative reports submitted by~ counties and districts across the nation (ministry of health ). surveillance network, which has been summarized elsewhere (wang et al. ). system, which surveys surveillance sites on a five-yearly basis, most recently in . . the ten-yearly national nutrition survey, a comprehensive, age-stratified, sex-stratified, and geographically stratified survey with a sample size of almost , (last completed in ). information system, a newly computerized administrative system that reports vaccination coverage to the nhfpc. . data gathered on health facilities, human resources, equipment, and services provided to outpatients and inpatients at various subnational levels and collected by the moh center for health statistics and information. reporting system, through which each county reports on notifiable diseases. after sars, this reporting system was massively upgraded to become web-based with reporting in real time (fig. ). . disease surveillance points on births, deaths, and on cases of notifiable diseases at selected points around the nation. . china's vital registration system, which covers around % of the nation's population but is biased toward urban and eastern locations. . national health services survey, which focuses on health status, service uptake, and health financing (meng et al. ) ; it was last conducted in . . national census, last conducted in (national bureau of statistics ), including substantive demographic information. . national one percent (inter-census) household survey, conducted between the ten-yearly national censuses, last conducted in . notwithstanding recent attempts to improve the health mis (hmis), monitoring china's hsr and health status relies largely on outputbased reporting or describes numeric improvements emanating from high-profile national initiatives (meng et al. ) , often lacking denominators (huang ; yip et al. ; ministry of health c). china does not have a tradition of locally representative, populationbased surveys on health outcomes; those which are undertaken are almost never independent. the disaggregated impact of health initiatives and local health status remains unknown except at crude (regional and urban-rural) levels (meng et al. ; ministry of health centre for health statistics and information ). this lack of data reduces the ability of governments to allocate resources according to local demography and disease epidemiology (which are changing rapidly with urbanization). in this context, quality implementation of new hmis initiatives (hipgrave b) will be critical; however, again these are national initiatives reliant on local funding. the hmis is mentioned as a priority for the second phase of the hsr (ministry of health a), but in general the monitoring and evaluation of china's health sector remains weak and non-independent and is not prioritized at subnational level. sources of funding and accountability for its use subnational governments, even at county and township level, are responsible for about % of social sector financing and for the provision of essential services including health (national bureau of statistics ). government expenditure on health depends heavily on local fiscal capacity (yip et al. ; wong ; feltenstein and iwata ) ; this varies widely across china, even after adjusting for formula-based "equalization transfers" from central government (wong ; bloom ). on average, tax revenue sharing and intergovernmental transfers finance up to % of subnational government expenditure (world bank ). this system bestows considerable power on provincial governments but also significant financial stress at the lowest levels of government. each level of government has considerable discretion in transferring resources to successively lower levels. provincial governments are the main recipients of the central government equalization grants and tax sharing and have significant autonomy in what they do with these funds. prefecture governments in turn have similar autonomy. in this system, funding for public service delivery by poorer townships and counties tends to be insufficient (wong ; zhou b) . apart from earmarked transfers from the moh and funds for selected nationwide priorities, local governments may withhold resources for lower levels or favor spending in more populous areas or on issues strategic to their career (zhou a; liu ) . this kind of bias at subnational levels can undermine progress on national development goals (yang ; uchimura and jütting ) . to supplement resources received from the higher levels, subnational governments raise resources from various fees, the sale of land use rights, and taxes on real estate transactions (world bank ). however, poor localities tend to have limited scope for such revenue generation. the imbalance between resources and expenditure responsibilities, particularly in poor jurisdictions, impacts on health service quality (yang ) and on household health expenditure (blumenthal and hsiao ; meng et al. ; world bank ) . moreover, income disparities have widened across localities and population groups within local jurisdictions (xing et al. ; zheng et al. ; undp china and china institute for reform and development ). the national urban-rural ratio of income per capita has risen from . in to . (up to within certain provinces) in ( fig. ) (national bureau of statistics ). at subnational level, only four provinces (sichuan, tibet, xinjiang, and yunnan) bucked this trend due to large subsidies to stimulate economic development and poverty reduction. subsidies for these provinces impact the shape of the line of best fit in fig. , which depicts provincial expenditure on health in relation to provincial gdp, per capita. aligned with policy priorities across sectors and programs. there are four distinct components of the national budget system, two of which impact on social sector spending: the general government budget (which relies on various taxation revenues and allocates funds to publicly funded services and activities) and the social security budget. the first of these allocates funds at the sectoral level; line ministries can then decide on and allocate earmarked transfers to the provinces (wong ; zhou b ). however, subnational government spending also relies on off-budget revenues (such as local taxes) for off-budget programs. monitoring is limited and there is little effort to align subnational budgets or plans with higherlevel priorities. moreover, apart from some individually monitored earmarked transfers, little information is available on whether governments actually spend money according to budgetary allocations or whether government expenditures and programs lead to the desired outputs and expected outcomes. achievement of high-profile input and output hsr targets masks the absence of substantive analysis of outcome-level impact (meng et al. ; yip et al. ) . audits tend to focus on detecting malfeasance, not program performance. additionally, china's budget and expenditure cycles are not synchronous. the fiscal year starts with the calendar year, but the budget is not endorsed by the national people's congress until the end of march. this delay reduces the budget's operational significance for subnational governments and central ministries (world bank ). fragmentation, information limitations, and delays in budget execution limit the ability of national authorities to transform policy priorities into resource allocation and results at the local levels (world bank ). total health expenditure (the) in china was us$ . bn in , at us$ per capita, and . % of gdp (china national health development research centre ). the/gdp is modest compared with industrialized countries, which averaged . % in (oecd ), but is average among low-and middle-income countries (lmic), whose the/gdp ranges from . % to % (e.g., indonesia . %, thailand . %, india . %, russia . %, vietnam . %, south africa . %, and brazil, . %) (see data at http://apps.who.int/nha/data base). health expenditure as a proportion of gdp has increased from~ % to~ % since , but numeric growth has been enormous due to china's rapid economic growth (figs. , , and ) . the sources of the have changed dramatically over time, reflecting changes in the role of government. marketization beginning in the s led to historically high out-of-pocket expenditure in ( %), but this had decreased to~ % in (china national health development research centre ), mostly through public subsidies for primary health programs, for health providers and for the social insurance schemes. in , tax-based government expenditures accounted for . % of the, social health expenditure . %, and out of pocket . % (fig. ) . overall, public expenditure on health as a share of the is similar to that of many other lmic and also to the united states (even higher if the government contribution to social health insurance is considered), but most high-income countries average around % (tangcharoensathien et al. ) . who calculates this figure differently and has china's figure at %; most nations in south and east asia average around % (see http:// apps.who.int/nha/database and hipgrave and hort ). to provide essential health services, reduce inequity, and provide financial protection against catastrophic health expenditure, governments must mobilize sufficient resources via: ( ) collecting revenues, ( ) pooling of risk, and ( ) purchasing goods and services (gottret and schieber ) . globally, three models of basic healthcare financing are practiced: nationalized health services, social insurance, and private insurance. china's total health expenditure % of gdp unit: million renminbi healthcare financing has evolved to a structure dominated by three social insurance schemes with almost universal population coverage: the urban employees basic medical insurance (uebmi) (financed by formal sector employers and employee contributions), the rural cooperative medical (insurance) scheme (rcms), and urban residents' basic medical insurance (urbmi). the latter two receive heavy government subsidization in addition to individual contributions (in a roughly : ratio). government health expenditure stems from tax revenue, as described above. china does not have tax instruments specifically designated to health expenses; the funds are allocated from overall tax revenue. these funds are used to pay the salaries of health workers, purchase equipment, and build infrastructure at various levels and for various specific programs such as public health subsidies or other schemes earmarked by the moh. government also funds a social assistance program (the medical financial assistance scheme), which provides cash for designated poor households to purchase health services. there also remains "free medical treatment" for those on the government payroll and for retired military and party cadres; these arrangements are slated for phasing out. however, government does not as yet contribute substantively to the funding of hospital care, which remains predominantly managed in-house from various sources of revenue (in particular, out-of-pocket payments and insurance) (state council ; barber et al. ). table summarizes the current basic health financing arrangements and benefit provided by the various health insurance schemes in china. it is evident that the major challenge remains fragmentation of the schemes and arrangements and the associated inequity and inefficiency. this is also highlighted in fig. , which depicts the large variation in average numeric benefit and other information about the various schemes. in this context, and given china's highly mobile population and the limited access of migrant populations to urban health services (di martino ), the government is prioritizing integration of the various insurance schemes (ministry of health a), but this is a difficult and complex proposition. before the hsr, to ensure financial accessibility, the chinese government priced primary healthcare services at below cost, but allowed providers to charge high prices for diagnostic tests using high-tech equipment, effectively cross-subsidizing primary services. providers could also levy a % profit on drug sales. under the prevailing fee-for-service payment modality, this created an incentive for providers to maximize profit by ordering tests and overprescription of drugs. cost-effective and efficient primary healthcare services were ignored by providers because they were not profitable; those who could not pay for services often chose to forego them . the recent reforms to provider payment, and those mooted for the future, aim to: ( ) encourage the provision of cost-effective and efficient primary healthcare services, ( ) reduce provider reliance on drug income and curb overprescription, and ( ) curb cost inflation. innovative provider payment methods, such as capitation (for primary heath mostly), gross budget, diagnosis-related groups (for hospitals), as well as performance-based payment for health workers, are being piloted at county and district level. other related policy reforms include a zero markup policy (for essential drugs), implementation of essential drug list, and so on (yang et al. a ). by international standards china's average health infrastructure level has been poor. for example, the number of hospital beds per population in was around , among the lowest in the world (ministry of health b). health infrastructure in china also suffered from a major urban-rural divide in the earlier stages of social and economic development. not only did urban health infrastructure enjoy greater public financial support, it attracted loans and other financial instruments because it was profitable and boosted the local economy. for many years, rural facilities received very limited government subsidy and relied on collective funding among farmers. rural health infrastructure lagged seriously, in terms of both the basic condition of health facilities (buildings, beds, etc.) and the equipment, while big urban hospitals acquired technical equipment of high quality. in , there were . hospital beds per urban residents, but only . in rural townships (ministry of health ). this inequity was recognized by national government, and in the majority of a national bond issue was used to finance a project earmarked for rural health, specifically to finance the rebuilding, renovation, and updating of medical equipment for rural providers, including primary health facilities such as cdc and mch institutions. the ndrc and its local branches approved the funding proposals for physical health infrastructure. more recently, the hsr allocated large sums to further improve physical health sector infrastructure (focusing on rural remote rural areas, but also urban community health centers). progress on this aspect of the reform has been very positive (yip et al. ). for the majority of china's population, access to western and formally regulated traditional chinese medicine (tcm) only commenced with the introduction of china's famed "barefoot doctors" in the mid- s. these cadres numbered . million at their peak (around one per people), but numbers fell rapidly with economic marketization and liberalization of population movement (bien ). moreover, village-level care lost its funding base with the dismantling of the rural cooperatives in the early s, and training and supervision of the quality of care provided fell off. as recently as the late s, many doctors lacked training to the level suggested by their rank and title (youlong et al. ) , and overprescribing of drugs and inappropriate use of parenteral preparations continue to exemplify the low quality of care, especially in rural areas (blumenthal and hsiao ; bloom and xingyuan ; zhan et al. ; pavin et al. ; dong et al. ; chen et al. ) . with economic marketization, medicine at all levels became privatized, physician salaries were paltry, standard consultation fees were fixed below cost (eggleston et al. ) , and over % of doctors' and health facilities' income derived from the sale of drugs (hu ) . as a result, doctors worked where they could be assured of income, patients became disillusioned with the care at rural clinics, self-referral to urban clinics increased, and the distribution of doctors, nurses, and health facilities was heavily biased to urban areas (yip et al. ; undp china and china institute for reform and development ; youlong et al. ; anand et al. ) ( table ) . residents of urban areas in china, particularly in the large eastern cities, enjoy physical access to health services to the same level as in most developed nations. however, like many other asian nations, china has trained more doctors than nurses or midwives, and there are progressively fewer staff with formal health training in progressively poorer rural areas (youlong et al. ; anand et al. ) (table ) . china includes tcm practitioners ( %) in headcounts of health staff (anand et al. ) . china is still paying for the interruption of university education during the cultural revolution of revolution of - , and the paucity of new village doctors trained since the breakup of the village cooperatives in the late s. first, as of , . % of china's doctors and . % of nurses had only completed junior college or secondary technical school level training, and % and % respectively had just high school or lower education (anand et al. ) . the duration and standard of professional education varies widely across the country (youlong et al. ) . village doctors are an ageing cohort, with a likely high attrition rate in the coming decade (xu et al. ). however, with massive increases in the number of formal trainees since , the distribution and quality of personnel are probably bigger problems than the overall number of china's health human resources. indeed, some data suggest an excess of trainees and the likelihood that many health graduates do not take up professional service. nonetheless, inequality and inequity in the distribution of doctors and especially nurses between and particularly within provinces remains extreme and has been linked to key health outcomes including infant mortality (anand et al. ) . authorities in china recognize the prevailing inequity in distribution of health human resources and have initiated training and other schemes to increase the number of qualified personnel and improve their distribution. the th five-year plan for health sector development, released in , sets targets for assistant physicians ( . / population) and nurses ( . ) and lays out plans for increased priority of staffing in rural areas and at community level, of personnel and financial support for poor rural and western health facilities by wealthier urban and eastern facilities, of intensive efforts to fill known human resource gaps among various health and allied health providers, and of tiered registration for doctors that first requires a period of rural service. a focus on community general practice is reiterated in the plan, with a target of , staff newly trained or upgraded personnel to provide such services. in addition, in a "guidance" the state council announced new roles for village doctors, recommending a wide range of tasks (government of china ). by , these cadres should be providing standardized primary care (following new clinical guidelines), implementing public health programs, undertaking disease surveillance, conducting community education, participating in health financing schemes, and maintaining individual e-health dossiers. in theory, it will be possible for the national hmis to monitor their work. the official engagement of village doctors in a national system is positive development and should improve public confidence in their services. however, payment for the planned elevation of village doctors' responsibilities will derive from a complex mix of funding streams (government of china ; ministry of health b) overseen and additionally funded by county-level authorities (government of china ) whose accountability for this national initiative will be to local government (wong ; zhou b) , not health authorities. it is well established that marketization and the de facto privatization of clinical care by salaried doctors working in public facilities had, by , resulted in china having one of the least equitable health systems in the world (the world health organization ), with over % of the being out of pocket (blumenthal and hsiao ; ho and gostin ; wang et al. ). one of the main objectives of china's hsr is to regulate the remuneration of doctors and to separate their income from choices on clinical care. however, while china has reduced the level of out-ofpocket expenditure on health to around % through increases in public funding and insurance initiatives (yip et al. ) , household health expenditure has not decreased either numerically or as a proportion of total household expenditure (meng et al. ) . although there is indirect evidence of increased non-health expenditure by insured households in comparison to before the schemes were introduced (bai and wu ), this objective of the hsr is proving to be the most difficult to achieve. china's the is increasing at around % per year, and a large proportion of the increase is due to payment of health facilities, doctors, and other providers by individuals or insurers. as patient expectations rise but out-ofpocket expenses remain numerically high, an increasing number of assaults of doctors by patients' families are being reported. on the other hand, the scheduled fees payable to doctors for listed services are set below cost, forcing clinicians and facilities to charge for other services, investigations, procedures, and drugs (including those not on the essential drugs list with unregulated prices) (blumenthal and hsiao ; ho and gostin ; wang et al. ; tian et al. ) or through accepting bribes and kickbacks (yang and fan ) . while the government has committed to improving both the quality of care provided by health providers, and is exploring remunerating them through capitation, diagnostic-related groups and performance-based incentives (ministry of health a), separating hospital management from doctors' income is proving to be the most difficult element of the current hsr (yip et al. ). as reviewed elsewhere (hipgrave a), public health services in china suffered badly under the marketization of the s and s. cdc in particular was weak, culminating in the sars epidemic in . public funding for preventive health services fell dramatically and was insufficient to even cover salaries. public health authorities were left to raise their own income through charging fees for services, including vaccination (for which fees were only completely dropped in ) and various inspections and screening. community approaches to disease control were abandoned in favor of vertical programs reliant on national or external funding, and disease surveillance was poor. sars and health authorities' realization of the epidemic of ncds due to ageing, urbanization, and decreasingly active lifestyles has led to major changes to public health programming in china. disease surveillance is now conducted online, in real time, and funding for cdc and preventive health has increased dramatically. new vaccines were introduced in , although globally recommended vaccines against haemophilus influenzae type b, pneumococci, human papilloma viruses, and rotaviruses are only available privately (ironically, through government providers). the largest boost to public health came with the hsr, when government introduced a minimum renminbi (rmb)/capita subsidy for public health/screening activities to be conducted across the nation. this had been pre-dated by various vertical preventive health programs, such as funding of hepatitis b vaccine since (cui et al. ) and national funding of the epi since . the hsr public health funding is provided by a mix of national and local authorities according to their ability to pay (problematic for poor counties in rich provinces) and the rmb was increased to rmb in ; it is much higher in wealthy areas. the funds pay providers to conduct the following services, notionally free of charge: ( ) maintenance of individual electronic health records, ( ) health education, ( ) vaccination, ( ) infectious diseases' prevention and treatment, ( ) screening and management of chronic diseases such as hypertension and diabetes, ( ) mental healthcare, ( ) child healthcare, ( ) pregnancy and maternity care, and ( ) healthcare for the aged. for the elderly and those with chronic diseases, this kind of screening, along with the introduction of zero markup and full reimbursement for drug treatment of ncds (yang et al. a ), has made a huge difference to their care. however, rollout of this initiative is slow, and although most targets are being met (yip et al. ) , monitoring is hampered by the absence of local denominators. moreover, some of the programs, such as management of mental illness, have not been founded upon a training program for staff ill-equipped to provide them. in addition, unpublished evidence gathered by unicef in suggests that some of the funds are being used as salary supplements to support the new responsibilities of village doctors (in public health and other programs) and that the volume of money allocated to some rural localities is actually too high, due to out-migration to cities. meanwhile, the increasing proportion of china's population living in urban areas, including most rural-urban migrants, cannot access such services. another boost to public health came with the moh's program, also introduced in , to prioritize interventions for certain vulnerable populations. these include: ( ) catch-up hepatitis b vaccination for those aged < years; ( ) cervical and breast cancer screening for women in rural areas; ( ) an expansion of the hospital delivery subsidies first introduced in , to cover women in all rural counties; ( ) free cataract surgery for the poor; ( ) free folic acid supplementation for rural women before and during pregnancy; ( ) improved stoves and fuel to reduce fluorosis; and ( ) introduction of eco-friendly toilets. again, targets for introduction of these measures have been set and rollout is proceeding (yip et al. ) . finally, although firm evidence of impact is scant, local authorities in most chinese cities have introduced public education and health literacy programs to enhance awareness on issues like diet, exercise, cigarette smoking, appropriate care of women before and during pregnancy, infants and young children, and the elderly. as usual, implementation of national guidelines on such activities depends on uptake and funding by other sectors and local authorities. the regular occurrence of outbreaks of food (xinhua ) and environmental contamination (human rights watch ) and other scandals with public health implications indicates the difficulty faced by national authorities in china's decentralized context. recent high-profile summaries of china's health system tend to focus on its administration and financing and neglect the considerable improvements in clinical care available to the local population. while standards at all levels of the service hierarchy vary very widely, health authorities have augmented the care available at virtually all public facilities across the nation. moreover, access to services to services has improved for all the population, albeit at high cost to both government and individuals (meng et al. ) . clinical services in china are conducted through a hierarchically arranged network of facilities ranging from tertiary referral centers in the large cities (most having high-quality diagnostic and laboratory equipment) to second-tier hospitals at county and district level. rural townships and urban communities are served by clinics or hospitals with varying capacity for inpatient care and surgery. at village or neighborhood level, public or (mostly) private facilities provide basic outpatient care, usually with an attached dispensary and possibly with links to a laboratory or radiology service. concern about the standard of care provided by local facilities has resulted in many patients self-referring to higher-level facilities and hospitals (table ) . as a result, hospitals in china tend to provide care for all level of illness, resulting in inefficiency and overcrowding. expenditure on hospital-based care as a proportion of the in china far exceeds that in many oecd nations (barber et al. ) , resulting in the high priority given to improving primary care, community general practice, and lower-level facilities in the hsr (yip et al. ; ministry of health a) and to moving outpatient care in particular from hospitals to primary care facilities (barber et al. ) . as would be expected for a nation of this size and variation, clinical services in china vary widely, from the world-class care available to residents in shanghai, beijing, guangzhou, and similar cities to the most basic care in rural clinics in far western china. similarly, models for the care of chronic illness and the use of day-care and hospital in the home vary widely, but in general these options are not yet well developed in china. the average length of inpatient stay is high in china compared to oecd nations (meng et al. ) , particularly in public hospitals, which account for % of total beds and % of hospital admissions (barber et al. ) . clinicians at community level have usually had training in tcm and many practice both western medicine and chinese medicine. however, the preparedness of clinicians in primary care for the wide range of conditions they treat varies widely. for example, china's current hsr acknowledges that the system's clinical focus has been ill-suited to the screening and outpatient care of chronic illness, an increasing priority as rates of noncommunicable diseases rise (the world bank human development unit ) . similarly, the high-volume model of clinical care in china is poorly suited to the management of mental illness (qin et al. ) , aged care and dementia, and prevention of tobacco-related illness and alcohol consumption, all of which are needed in china (the world bank human development unit ; phillips et al. ; yang et al. b; zhou et al. ; chan et al. ) . with respect to quality of care, in the last decade china has moved to standardize many clinical pathways and practices, and the concept of evidence-based medicine is increasing. however, attention to such standards and their influence on clinical care is perceived to be low (yang and fan ) . moreover, funding for and the quality and independence of clinical research, access to information, and the ability of clinicians to practice independent of the profit motive are china's pharmaceutical sector has been one of the most problematic for health authorities over recent decades and the focus of major reform efforts in the last few years. in , . % of china's the was on drugs (hu ), compared to % in developed nations (seiter et al. ) . excessive drug prescription was common in rural china (zhan et al. ; pavin et al. ; dong et al. ; chen et al. ; yu et al. ) , and there is evidence that china's rural health insurance scheme was encouraging overprescription (chen et al. ; sun et al. ). drug sales continue to provide the largest income source for china's county health facilities; doctors have a pecuniary incentive to prescribe more and more expensive drugs (chen et al. ; yu et al. ) . hospitals and doctors profit significantly from the sale of drugs (yu et al. ; the world bank group east asia pacific region ), affecting financial access to healthcare meng et al. ) . weak regulation of drug manufacture and distribution raises safety concerns (yu et al. ; guan et al. ) . previous efforts to improve the pharmaceutical sector had limited effect. the impact of laws, decrees, and separate price reductions over - was constrained by hospital financing/income generation, market influences, and patient preferences (chen et al. ; yu et al. ) . price controls were undermined by manufacturers, wholesalers, and retailers and by hospitals and physicians controlling the prescription of price-controlled drugs (hu ; yu et al. ; chen and schweitzer ) . new drug approvals were issued at astonishing rates (ho and gostin ) and the former head of the national drug administration authority was executed in for accepting bribes. kickbacks and corruption continue to mar the sector (yip et al. ; yang and fan ) . acknowledging these problems, china's hsr included establishment of a national essential medicines scheme (nems) to improve population access to and reduce the cost of essential medicines (state council ), particularly at grassroots (township and village) level. the scheme covers drug production, pricing, distribution, procurement, prescribing, and payment (hu ) and a new national essential drugs list (nedl) for primary healthcare institutions. the nedl comprises western drugs and tcm commodities (increased from western and in ) for storage and use by grassroots facilities. bidding prices for nedl drugs were capped (schatz and nowlin ) , and a "zero markup" (no profit) policy was introduced, although markups remain allowed at county-level and higher facilities. by late january , . % of township hospitals and . % of village clinics had implemented the policy (ministry of health d). in addition, most (urban) districts and (rural) counties had made nedl medicines reimbursable by the various health insurance schemes, with higher reimbursement rates than for nonessential medicines (ministry of health c). finally, to regulate the pharmaceutical market and distribution of essential drugs, the nems introduced province-wise, collective, internet-based public bidding and procurement for nedl medicines. these four elementsthe nedl, zero markup, reimbursement of certain drug costs by insurers, and public procurementwere designed by the government to wrest control of the public pharmaceutical sector from the private sector. however, the official hsr documents encourage local adaptation of the broad design (ho ) , including the nedl (which has indeed been widely augmented (guan et al. ; shi et al. ) ) and strategies to compensate providers for the zero markup policy. few evaluations of the impact of the scheme have emerged. very early indications suggested little change in prescribing practices (yip et al. ) , but a small field evaluation found that while drug procurement has been systematized and the cost of care had declined coincident with reduced drug prices, manufacturers have not uniformly supported the changes, and some drug prices have actually increased. provider compensation for reduced income was mostly ineffective, forcing some to seek alternative sources of income within and outside the health sector. rational drug prescribing had improved in this study. the loss of drug income had forced health facilities to rely more on public financing, and providers complained of higher workload and lower incomes (yang et al. a) . similar issues were found in another study in different locations (xiao et al. ) . the nems particularly impacts small rural health facilities and will again rely on considerable local support for its implementation. meanwhile, provinces are continuing to augment even a revised version of the nedl (tang et al. a) , and zero markup has not yet been applied in county or higher-level facilities. while insurance reimbursement and capitation may help to improve prescribing practices and reduce patient outlays, more control of procurement, manufacturer, and prescriber practices are required. the recently announced reforms of county hospital funding and administration include a major focus on drug procurement, prescription, management, and pricing (state council ). as a consequence of the marketization of china's health sector in the s, provision of health services was opened significantly to private providers. the number of private providers increased rapidly and now comprises a significant proportion of the market. for example, in , private hospitals accounted for only . % of total hospitals, but the share had increased to . % by . in among all , health facilities (hospitals, clinics, and other institutions), % operated as "private" entities. reports indicated that private health providers can offer services at a cheaper price and shorter physical distance and waiting time for patients (deng et al. ) and are highly active in the provision of healthcare in china. however, most private facilities are small and poorly equipped, and collectively they only employed . % of the total labor force, owned . % of total medical beds, and received . % of total patient hospital visits (ministry of health b). compared with public facilities, a large percentage of elderly physicians and new laborers in health market are practicing in private clinics (tang et al. b ). this staffing structure could have negative impact on quality of services. in general, despite rapid development in recent years, private health services are at an early stage of development in china. one major reason is that the evolution and current standing of national policy generally still favors public providers in terms of resource allocation, stewardship (entry and registration control), opportunities for promotion, and social insurance entitlements. this accounts for common challenges in the private sector, i.e., lack of technical capacity, poor infrastructure, and thus compromised service quality. health authorities are now promoting a robust private sector to encourage competition and efficiency within the health sector, aiming for % of beds and services to be privately provided by . however, subsidization of grassroots level public institutions may prevent moves in this direction. while china's progress on major health indicators during the years immediately following the foundation of the prc is unparalleled (jamison et al. ) , marketization and the unaffordability of healthcare for a large proportion of the population stymied progress in the s and s. there are even suggestions that child mortality rates in china actually rose in the s (banister and hill ) , with the breakup of the communebased health cooperatives. moreover, improvement in certain indicators has been slow. for example, urban maternal mortality has been slow to fall, almost certainly because reductions in maternity risk for urban residents have been diluted by the much higher risk of death in pregnancy among urban migrants (fig. ) . geographic disparities also remain great, particularly between eastern and western provinces . in general, the priority given to china's recent hsr acknowledges that progress in its population's health status was less than could have occurred, given the nation's economic growth since the s (yip et al. ) . acknowledgement of this is the government target of a one-year increase in life expectancy by (ministry of health a). the most comprehensive analysis of the causes of death and disability in china, published in mid- , highlighted the dramatic evolution of its demographic transition, with ncds now making up all but two of the top causes of lost life years, and most infectious diseases having fallen precipitously. the report also noted the contribution of air and household pollution to mortality and morbidity and the need for cross-sectoral action to tackle the major causes of ill-health in china (yang et al. b) . nonetheless, in , average life expectancy in china was . years, and in the maternal mortality ratio was . / , live births, infant mortality rate . ‰, and under-five mortality rate . ‰ (china national health and family planning commission ). these figures compare favorably with other developing countries, and china's performance in reducing rural maternal and neonatal mortality has been outstanding (feng et al. b (feng et al. , . china has already achieved all the health targets in mdgs , , and and achieved the target on reducing child underweight in the early s. urban-rural disparity in under-five and particularly maternal mortality has declined since , but remains high for child underweight and stunting and especially for child micronutrient deficiency (unicef china, unpublished data; ). challenges to population health status have been alluded to already and include the rise of ncds, especially smoking-related illness (the world bank human development unit ), illness due to environmental damage and air pollution (the world bank human development unit ; millman et al. ) , urbanization, and the provision of services for newly arrived migrants (gong et al. ) . the prevention of accidents and injury will also play an increasing role in maintaining china's trajectory on reducing preventable death and ill-health (wang et al. b) . as the population ages, private and institutional care of the elderly is another major issue for china's health and other social sectors. china's progress in maternal and child health, urban health, and communicable disease control are very encouraging, but the nation's health system now faces a vastly different range of issues from those it faced before. in addition to health insurance reforms that commenced in , in many ways the comprehensive health system reforms announced in have been highly successful. insurance coverage is almost universal, and the benefit package is gradually expanding, even for outpatient services, although a system for ensuring coverage for the huge population of rural-urban migrants remains under development. introduction of public health screening and management, building of new health infrastructure and expansion of community-based services, measures to control profiteering from the sales of drugs, scale-up training of health personnel, and other measures were both needed and are being implemented. on the other hand, the reform of hospital management and financing remains at the pilot stage, with suggestions but no formal guidance on the model to be followed. china's hsr is encouragingly specific but not prescriptive on strategy. monitoring the reform remains predominantly output-based at macrolevel; no detailed independent assessments have been undertaken, and population-level studies of health outcomes related to the reforms have not been undertaken. moreover, mechanisms to incorporate patient feedback into health service provision have not been established and may be ignored if local economic, political, or vested interests override such input, as has been observed in relation to china's natural environment. public financing of the health sector, although modest by global standards, has improved, particularly in relation to the proportion of the that is out of pocket. but costs are rising faster than government inputs, and poorer constituencies remain least able to fund public services, despite having the greatest needs. as a result, proportional household expenditure on healthcare has not declined. urban residents of china's industrialized eastern provinces enjoy a high quality of healthcare and access to trained personnel. this is not the case for poorer rural residents, particularly in the nation's vast western region. the official engagement of village doctors to provide publicly funded health services in rural areas should improve the standard of and public confidence in their care, but the burden on this ageing cadre of staff is rising and may be untenable; again, accountability for this national initiative will be to local government and health officials unused to the application of treatment algorithms, performance-based assessment, and clinical audit. concern about the care provided by community providers continues to result in many patients self-referring to higherlevel facilities and hospitals. population health in china is threatened by the rise of ncds, especially illness due to diabetes, cardiovascular disease, overweight, tobacco smoking, environmental damage, and air pollution. the prevention of accidents and injury and management of mental illness will also play an increasing role in maintaining china's trajectory on reducing preventable death and ill-health. the required focus of the health sector on chronic illnesses, aged care, and outpatient services requires a dramatic increase in the engagement and stewardship of community providers. this has been a major focus of china's health reforms, now well into their second phase, and it is likely that further major policy and financial inputs will be announced before this phase concludes in . the private sector will play an increasing role in the provision of health services in china, but a higher level of stewardship and the use of financial mechanisms to reign in escalating costs will almost certainly be required, especially for hospital care. to ensure consistency and transferability, this may involve stronger oversight by and involvement of national health policy and financing authorities, notwithstanding the power vested in subnational authorities in china's system of 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healthcare reforms health human resource development in rural china pharmaceutical supply chain in china: current issues and implications for health system reform drug prescribing in rural health facilities in china: implications for service quality and cost why hasn't china's high-profile health reform ( - ) delivered? an analysis of its neoliberal roots maternal deaths among rural-urban migrants in china: a case-control study comparative study on structural changes in income disparities in urban households in chongqing municipality, shanghai municipality and sichuan province reforming china's local government governance. in: incentives and governance: china's local governments incentives and governance: china's local governments epidemiology of alcohol use in rural men in two provinces of china key: cord- -dd gw t authors: armbruster, walter j.; roberts, tanya title: the political economy of us antibiotic use in animal feed date: - - journal: food safety economics doi: . / - - - - _ sha: doc_id: cord_uid: dd gw t this chapter examines the evidence for antibiotic resistance in the united states and globally, the public health implications, and the impact of—and related industry and political responses to—antibiotic use in animal feed. in , the swann report in the united kingdom noted a dramatic increase in antibiotic-resistant bacteria in food animals receiving low levels of antibiotics in their feed. while the food and drug administration of the united states sought to control antibiotics in animal feed as far back as , only in were such regulations fully implemented. the farm-level costs of such controls are estimated by the us department of agriculture’s economic research service to be minimal, while the centers for disease control and prevention’s estimates of the public health costs of antibiotic resistance without implementing controls are $ billion annually. the complex interactions which exist between economic interests, regulatory policy, and human and animal health are explored in this chapter. antibiotic resistance has been widely recognized as a serious public health problem. hence, there is a major public good to be realized in safeguarding the effectiveness of existing antibiotics and creating new ones. antibiotics are used to treat human infections and used in animal agriculture. while many drugs are dual-use, others are animal-or human-use specific. the production benefits of sub-therapeutic levels of antibiotics in animal agriculture have been recognized since the late s (cast ) . in animal agricultural production, antibiotics are used at therapeutic levels to treat infections and at sub-therapeutic levels to prevent infections and promote animal growth (sneeringer et al. ; van boeckel et al. ; who ) . as the organizational complexity of the animal agricultural supply chain increased, the number of economic stakeholders in on-farm antibiotic use has also increased. the major stakeholders include pharmaceutical companies, production integrators, feed suppliers, farm groups, producers, restaurants, food retailers, the public, the medical community, the scientific community, government regulators and policy makers. each of these stakeholders faces a different set of incentives and disincentives related to on-farm use of antibiotics in animal agriculture. knowledge of these incentives and disincentives has evolved with the accumulation of scientific and economic research. to understand the regulatory outcomes governing antibiotic use in agriculture, it is important to recognize the political economy context in which they are developed. the various stakeholders are driven by the relative benefits they receive under policies as they affect their industry segment (zilberman et al. ). alexander fleming, who discovered penicillin, warned that "…misuse of the drug could result in selection for resistant bacteria" (rosenblatt-farrell ) . antibiotic resistance (ar), a term sometimes used interchangeably with antimicrobial resistance, occurs when bacteria change in ways that make antibiotics less effective in treating infections, thereby allowing the bacteria to survive, multiply, and cause additional harm. ar has been recognized as a serious public health problem among the medical and scientific communities. antibiotics are used to treat human infections and used in animal agriculture. particularly concerning is resistance for those antibiotics that are of value in treating human health issues, the so-called medically important antibiotics. the use of antibiotics along with other advances in agricultural technology has facilitated the concentration of animal production on farms in the united states (us) and elsewhere. for example, in , % of all us sales of hogs and pigs were by the % of farms with , or more head, and % of all layers were produced on the less than % of farms that sold , or more to egg producers (nass ) . the majority of the production of hogs, broilers, and eggs occurred under contractual arrangements between growers and integrators, with the integrators prescribing certain production practices, including the use of antibiotics for treating infections, for disease prevention and for promoting growth. many of the antimicrobial drugs administered to food-producing animals are also important in treating humans, worldwide. domestic sales of medically important antimicrobial drugs for use in food-producing animals in the united states accounted for % of the domestic sales of all antimicrobials approved for use in food-producing animals. and, % of domestic sales of all medically important antimicrobials approved for use in food-producing animals are labeled for therapeutic use only . importantly, animal drug sales data represent products sold or distributed by manufacturers through various outlets for intended sale to the user. since veterinarians and others in the supply chain may have substantial inventory on hand for possible use, these numbers do not accurately reflect the amount of product ultimately administered to animals. given the number of humans versus a much larger number of animals in each of the species, as well as other confounding factors, no definitive conclusions from any direct comparisons between the quantities of antimicrobial drugs sold for use in humans versus animals can be drawn (fda a) . there are obvious situations where antibiotics are required to treat sick animals in agriculture, but the proper therapeutic use versus prophylactic use remains in question among stakeholders. farm groups and others in the food animal supply chain recognize that antibiotics in animal feed keep animals healthy and meat costs down. but over medical doctors and other healthcare providers signed petitions to congress asking for new legislation to reduce non-therapeutic antibiotic use in food animals (miller ) . the animal health industry is very concerned that needed preventative use will be threatened by the recent fda ban on use of medically important antibiotics for growth. fda classifies as therapeutic those antimicrobials targeted for treatment, control, and prevention of bacteria or disease identified on the product label. fda explicitly states that the use of antibiotics in animal feed for growth promotion is not allowed. those who characterize preventative use as routine overlook the difference between treating animals versus humans. if preventative measures are not taken and a disease outbreak occurs and spreads rapidly within a flock or herd, it risks large numbers of animals developing a deadly, high mortality disease. waiting until a disease is clearly evident makes successfully treating the active infections very difficult due to the large number of animals involved. by contrast, a human patient can generally be quickly diagnosed and treated. while some are concerned that producers will continue to use antibiotics for growth under the guise of prevention, the fda-approved label is specific about dose and duration for a specified bacterium or disease. off-label use of antibiotics in animal production is illegal, and fda only allows a veterinarian to decide whether to use or not to use a preventative treatment based on their judgment of a disease threat (carnevale ) . in an economic framework, antimicrobial resistance can be considered as an unwanted side effect, or externality, associated with the use of antibiotics. the efficacy of antibiotics can be considered as a public good that must be managed with government involvement. this is because the costs of overuse by any single individual are borne by society and, in the case of antibiotics, globally. hence, not only is there a role for government involvement with the animal agriculture industry in managing the stock and use of antibiotics as an important public good, but it must be done cooperatively across countries. in , the united kingdom's (uk) parliament received the swann report, which concluded that using antimicrobials at sub-therapeutic levels in food-producing animals created risks to human and animal health (joint committee on the use of antibiotics in animal husbandry and veterinary medicine ). it noted a dramatic increase in numbers of animal-origin bacteria strains which showed resistance to one or more antibiotics and that these strains could transmit resistance to other bacteria. it recommended that only antimicrobials that are not medically important for humans should be used without prescription in animal feed and that antimicrobials should only be used for therapeutic purposes under veterinary supervision. the primary reason that producers were using these sub-therapeutic doses of antibiotics was to promote faster weight gain in the animals. in , a us food and drug administration (fda) task force was charged to do a comprehensive review of antibiotic use in animal feed (fda ). its report found that sub-therapeutic use of antimicrobials in food-producing animals was associated with development of resistant bacteria and that treated animals might provide a reservoir of antimicrobial-resistant pathogens capable of causing human disease. the task force recommended that medically important antimicrobial drugs meet certain guidelines they identified or be prohibited from growth promotion or other sub-therapeutic use by certain dates. further, antimicrobials not meeting the guidelines should be limited to short-term therapeutic use only under veterinarian control. in the s, the animal health institute (ahi), a us trade association for the animal drug industry, funded an on-farm study to determine the impact of adding low-dose antibiotics to chicken feed. within week of adding tetracycline, the intestinal flora in the chickens "…contained almost entirely tetracycline-resistant organisms" (levy et al. ). the antibiotic resistance was not located in the dna of the bacteria which is hard to transfer among bacteria but in plasmids located on the outside surface of the bacteria. plasmids are easily exchanged among bacteria living in the intestine. importantly, the tetracycline-resistant bacteria in the chicken's intestines were resistant to multiple antibiotics. furthermore, some members of the farm families began to harbor these same antibiotic-resistant bacteria in their intestines within months. in , the fda proposed withdrawing the new animal drug approvals for the sub-therapeutic uses of human medically important penicillin and tetracycline in animal feed based on lack of evidence to show they were safe. however, the us congress intervened and asked for more research first. the ahi was one of the groups advocating in congress to delay regulation pending additional research, then and now. in congressional testimony, richard carnevale, vice-president at ahi, testified that while it is possible for human antibiotic resistance to be caused by antibiotic use in farm animals, "…it does not happen enough that we can find it and measure it" (carnevale ) . this statement contradicted the data produced by the ahi-funded study by levy (levy et al. ) that was published in the prestigious new england journal of medicine in . richard carnevale also mentioned in his testimony that prior to joining ahi he was deputy director of new animal drug evaluation in fda and had worked at usda in the food safety and inspection service (fsis). his testimony illustrates two points in the political economy of food production: ( ) how industry has an opportunity to influence regulators' decision-making via the revolving door of employment and ( ) how industry carefully selects its facts to present a point of view that bolsters their profits, namely, for drug companies in this case (oreskes and conway ) . another example of the political economy in action involved usda prohibiting an agency research microbiologist from talking about the significant levels of antibiotic-resistant bacteria detected in the air near midwest hog confinement operations (union of concerned scientists ). a third element of the political economy is shown by industry efforts to influence policy makers through campaign contributions and strong lobbying of proposed legislation which may affect their bottom line. pharmaceutical companies spent at least $ million and agribusiness companies another $ million during , in large part to fight possible limits on antibiotic use in animal feed (mason and mendoza ) . in response to congressional pressure in the late s, fda withdrew its proposal and instead funded three studies to determine the impact of using low levels of antibiotics in animal feed (industry won this round, obtained a delay in regulations, and funded more reports): . in , the national academy of sciences reported that there was limited epidemiological research on the topic. available evidence at that time did not prove nor disprove dangers of seven therapeutic antimicrobials in animal feed, but that did not preclude the existence of hazards (national academy of sciences ). . in , the fda funded the seattle-king county department of public health to analyze salmonella and campylobacter, which were chosen as models to estimate the flow of potentially pathogenic bacteria from animals to humans through the food chain. their report was based on sampling retail meat and poultry and investigating salmonella and campylobacter enteritis cases in humans. isolates from human illness cases and retail foods were analyzed for antibiotic resistance of these pathogens, using plasmid analysis and serotyping. the report found that campylobacter was a more common cause of enteritis than salmonella and appeared to flow from chickens to humans through consumption of poultry products, with tetracycline resistance being plasmid-mediated (seattle-king county department of public health ). . in , the institute of medicine (iom) undertook a fda-requested independent quantitative risk assessment of human health impacts from sub-therapeutic use of penicillin and tetracycline in animal feed. based on a risk-analysis model of salmonella infections that resulted in human death, the iom did not find substantial direct evidence that sub-therapeutic use in animal feed posed a human health hazard. however, they found a considerable body of indirect evidence implicating both sub-therapeutic and therapeutic use of antimicrobials as a potential health hazard and strongly recommended additional study of the issue (institute of medicine ). numerous research results quantifying the extent of the antimicrobial resistance problem have been published in the scientific literature and indicate a growing and serious threat to human health. the many channels for ar to affect humans are shown in fig. . . the two main channels for food animals are ( ) ar bacteria in the food animal's gut can contaminate the meat or poultry eaten and ( ) environmental contamination, such as manure used to fertilize fields that contain ar bacteria, may contaminate the environment and some of the food crops grown on these fields. consumer reports (cr) tested products sold in us supermarkets and found resistance to multiple antibiotics in the following percent of samples: beef %, shrimp %, turkey %, and chicken % (consumer reports ). cr also found that ground beef from conventionally raised cows was twice as likely to contain antibiotic-resistant pathogens as ground beef from cows raised without antibiotics. like other threats to human health, ar is best managed across national boundaries. increasing international trade may spread antibiotic resistance through imported food products as more trade agreements are approved. this scenario could be exacerbated to the extent fsis approves additional international facilities, local regulations, and inspections as "equivalent to the united states." future trade agreements will need to include provisions which address reduced use of medically important antibiotics in producing food animals. numerous trusted institutions from the united states (us) and the united kingdom (uk) as well as international organizations such as the world health organization (who), the united nations' food and agriculture organization (fao), and the world organization for animal health (oie) have acknowledged the threat of antibiotic resistance related to use in producing food animals. the fol- lowing excerpts from a few recent reports highlight the role that low-dose antibiotic use in animal feed plays in spreading ar. the centers for disease control and prevention ( b) reported that: each year in the united states, at least million people acquire serious infections with bacteria that are resistant to one or more of the antibiotics designed to treat those infections. at least , people die each year as a direct result of these antibiotic-resistant infections. many more die from other conditions that are complicated by an antibiotic-resistant infection. antibiotic-resistant infections add considerable and avoidable costs to the already overburdened u.s. healthcare system. in most cases, antibiotic resistant infections require prolonged and/or costlier treatments, extend hospital stays, necessitate additional doctor visits and healthcare use, and result in greater disability and death compared with infections that are easily treatable with antibiotics. the total economic costs of antibiotic resistance to the u.s. economy has been difficult to calculate. estimates vary but have ranged as high as $ billion in excess direct healthcare costs. adding on the costs for lost productivity brings the total societal costs (sic) for ar to $ billion a year ( dollars). (cdc a, p. ) this cdc report also indicates that foodborne cases are responsible for % of human ar infections ( fig. . ). thus, societal costs of these ar foodborne illnesses could total $ billion annually of the $ billion/year total costs to the us economy. these societal costs could be prevented if the foods were free of contamination with ar pathogens. there may be additional costs associated with environmental pathways of human contamination from use of antibiotics in meat production, such as exposure to contaminated water. in , who stated: "antimicrobial resistance (ar) is an increasingly serious threat to global public health. ar develops when a microorganism (bacteria, fungus, virus or parasite) no longer responds to a drug to which it was originally sensitive. this means that standard treatments no longer work; infections are harder or impossible to control; the risk of the spread of infection to others is increased; illness and hospital stays are prolonged, with added economic and social costs; and the risk of death is greater-in some cases, twice that of patients who have infections caused by non-resistant bacteria. the problem is so serious that it threatens the achievements of modern medicine. a post-antibiotic era-in which common infections and minor injuries can kill-is a very real possibility for the st century" (who , p. ) . in , oie noted: "today, in many countries, including developed countries, antimicrobial agents are widely available, directly or indirectly, practically without restriction. of countries recently evaluated by the oie, more than do not yet have relevant legislation on the appropriate conditions for the import, manufacture, distribution and use of veterinary products, including antimicrobial agents. consequently, these products circulate uncontrolled like ordinary goods and are often falsified." to date, there is no harmonized system of surveillance on the worldwide use and circulation of antimicrobial agents. that information is necessary, however, to monitor and control the origin of medicines, obtain reliable data on imports, trace their circulation, and evaluate the quality of the products in circulation. it is in this context that the oie was mandated by its member countries to gather that missing information and create a global database for monitoring the use of antimicrobial agents, linked to the oie's world animal health information system (wahis). that mandate is also supported by fao and the who within the framework of the who's global action plan on antimicrobial resistance. the database will form a solid basis for the three organizations' work to combat antimicrobial resistance (oie , p. ) . in , a uk evaluation of academic, peer-reviewed research articles addressing antibiotic use in agriculture determined that only % found no link and % found a positive link between antibiotic use in animals and antibiotic resistance (ar) in humans (o'neill ) . taken to evaluate proposals to ban the use of growth-promoting or sub-therapeutic levels of antibiotics in food animals, usda's economic research service (ers) economists added questions on antibiotic use to the agricultural and resource management survey (arms). arms is a nationally representative survey of farms administered jointly by ers and usda's national agricultural statistics service (nass). hog producers were surveyed in and , and broiler producers were surveyed in and . ers also drew upon their research using data in the national animal health monitoring system (nahms) to develop a model to estimate the impacts of withdrawing antibiotics for other than therapeutic use in food animals. using monte carlo simulations, ers estimated the impacts of eliminating antibiotic use for growth promotion of poultry and pork, not just the fda-specified "medically important" antibiotics (table . ). simulation results showed less than . % reduction in output and an approximate . % increase in wholesale prices, netting pork producers greater total revenue of . % and poultry producers . %. ers concluded that these small effects were not statistically significant (sneeringer et al. ) . these ers results are consistent with research studies post- indicating that productivity gains from using antibiotics for growth promotion were lower than earlier research had found (teillant and laxminarayan ) . another report suggested that phase out of growth promotion use in food animals over a -year period would avoid most of the % projected global growth in such use and cost agricultural sectors a small portion of the costs of ar in each country. further, reduced infection risk and costs of medications would cover most farm-level costs of improving animal husbandry practices to offset loss of antimicrobials for production purposes (laxminarayan and chaudhury ) . presuming that any new antibiotic classes probably will not be made available for veterinary medicine, it is important to preserve the effectiveness of existing antibiotics which are necessary for treatment of infectious diseases to maintain animal health (teillant and laxminarayan ) . an alternative to encourage development of new antibiotics would be to delay or not approve drugs which mimic others, but for which the applicant company has not performed antibiotic research (amábile-cuevas ). even better, several production practices may be used to enhance animal health in the absence of using antimicrobials for growth or for prophylactic disease prevention (sneeringer et al. ; who ; macdonald and wang ) . these include: • improved management practices, such as more space per animal and better control of the housing environment • tightened biosecurity to prevent diseases and improve productivity by avoiding introduction of infectious agents by wild animals, domestic pets, and nonessential workers or other humans; through increased cleanliness of production facilities; and from timely removal of dead animals • optimized nutrition to increase growth and mitigate stress-related factors and provide vitamin and mineral supplements to reduce disease susceptibility • improved gut microflora to improve feed efficiency by providing enzymes, organic acids, prebiotics, probiotics, and immune modulators • vaccinations to prevent some diseases • hazard analysis critical control point plans to improve productivity in the absence of using sub-therapeutic antibiotics in animal production generally, these practices may raise production costs modestly at the farm level because of the need for more resources required to successfully manage them. since ers found no statistically significant evidence that antibiotics reduce the costs of producing pork or broilers, we conclude that there are small or no costs to producers from withdrawing growth-promoting or prophylactic uses of antibiotics in production of food animals. in contrast, the public health benefits of withdrawing these antibiotics from agriculture are significant. as reported above, cdc estimates that the medical costs and productivity losses of ar illnesses attributed to agriculture are $ billion us dollars annually. the benefit/cost analysis becomes $ billion in public health protection benefits vs. the very small costs to animal production from withdrawing antibiotics from non-therapeutic use. in other words, the protection of the public health will come at little or no cost to agriculture. furthermore, this benefit/cost analysis provides a conservative estimate of public health protection benefits. the cdc public health protection benefits do not include estimates for protection from an increasing number of "superbugs" that would be created if low-level antibiotics would continue to be used. and cdc does not include the costs of long-term health outcomes caused by foodborne pathogens (see chap. ). aside from costs to agricultural producers, there are also other societal costs related to ar and connected to antimicrobial use in animal production, both in their production and use/misuse, affecting human and environmental health. in economic terminology, these costs are considered negative externalities to society from the individual use of antibiotics. moreover, since the science of ar is unfolding, there may be additional unknown human health and environmental risks associated with the use of antibiotics in food animal production. pharmaceutical production. a major issue involved with manufacturing of active ingredients for antibiotics and the effluent from factories producing them is the potential to contaminate nearby water systems. pharmaceutical factories often contaminate the environment, since guidelines for pharmaceutical waste discharge focus on chemicals used in manufacturing, rather than active pharmaceutical ingredients. this is a primary concern in countries outside the united states, but international trade makes it a worldwide problem. use and misuse. worldwide, antibiotics are used heavily in animal agriculture. this practice has created resistance problems transmissible from animals to humans. for example, china has mrc- colicin resistance in pork and salmonella resistance to cephalosporins at higher levels than in the united states (zhang et al. ) . their practice of applying human waste on fields and the closeness of population centers to agriculture contribute to cross-mixing of pathogens in china. parasites are common in chinese soil and can contaminate pork. and low levels of chlorine in chinese water supplies allow accumulation of biofilms containing antibiotic-resistant pathogens in water pipes. in india, manufacturing of pharmaceuticals and waste disposal practices lead to contamination of water and soil. further, over-the-counter antibiotics are available and heavily used there. farm antibiotic use is of concern in india and china in poultry and pigs (apua newsletter ). the threat of superbugs via food is worldwide, due to the distribution of animal food products from china (zhang et al. ; zhu et al. ) . rosenblatt-farrell ( ) drew upon existing literature to identify additional environmental paths to exposure to antibiotic resistance. veterinary antibiotics are frequently excreted intact from food animals (table . ). for the widely used tetracycline, - % of the antibiotic is excreted in the feces or urine and not metabolized by the food animal. the transfer of this animal waste to croplands may transfer antibiotics and possibly ar pathogens. in one study, ar genes in soil increased fourfold after manure from hog and dairy farms was applied to the soil (moyer ) . runoff from farms, feedlots, or cropland can lead to antimicrobial resistance problems in soil, surface water runoff, and groundwater. animal waste held in lagoons allows birds and insects to become contaminated with antibioticresistant bacteria, and flies around food animal facilities can carry antibioticresistant enteric bacteria which increases potential human exposure. migratory birds and seagulls which become infected with antibiotic-resistant bacteria or viruses can widely transmit resistance to other birds as well as marine life. others note that antibiotics should never be used to compensate for poor hygiene and husbandry practices or conditions in livestock production (van boeckel et al. ) . veterinary medicine should only use antibiotics to treat diagnostically determined bacterial infections not otherwise treatable and only those antibiotics authorized for the diagnosed pathogenic indication and the specific bacteria involved. further, given the potential for acute diseases that require immediate treatment, it is important that routine testing (surveillance) be carried out for farm-specific pathogens for all relevant antibiotic classes (silley and stephan ) . who also emphasizes the need for surveillance and monitoring antimicrobial use in food-producing animals to evaluate the extent to which their guidelines are implemented. fda has increased regulation of antibiotic use in food animals. as noted in sect. . above, fda attempted to withdraw new animal drug approvals for subtherapeutic uses of human medically important penicillins and tetracyclines in animal feed based on lack of evidence to show they were safe. after industry opposition and congressional intervention to require further study, this early policy response was withdrawn. subsequently, the us congress gave something to each group when it enacted the animal drug availability act (adaa) in . this act both table . , fda in recent years issued three core documents to implement a policy framework for judicious use of medically important antimicrobial drugs in food animals: on january , , fda announced that it had completed implementation of the guidance for industry # . this means that medically important antimicrobials provided to food-producing animals may no longer be used for growth promotion purposes and may be used to treat, prevent, or control animal illnesses only under direction of a veterinarian. fda worked with industry participants to implement this voluntary compliance to slow development of antimicrobial resistance and preserve effectiveness of medically important antibiotics. more than percent of new drug applications subject to gfi # were converted from over-the-counter to prescription status, applications were withdrawn, and all applications indicating production use withdrew that specified use. fda also indicated plans to work with industry stakeholders to support antimicrobial stewardship in food animal production and to evaluate the effectiveness of strategies to reduce antimicrobial resistance development under the allowed uses (fda ). some industry stakeholders in the supply chain are actively engaged in responding to consumer and general public health concerns about ar in the food supply chain amidst mounting scientific evidence, but responses vary considerably by country, place in the supply chain, and individual company. aside from farm groups, stakeholders include feed companies, pharmaceutical companies, integrators or meat processors, restaurant chains and other retail outlets, and consumer and other interest groups. pharmaceutical companies. in the case of pharmaceutical companies, little evidence exists that they are responding to the ar problem yet. as described earlier, most antibiotics are produced in india and china, and their production has resulted in significant risk, especially environmental risk. regulators need to set minimum standards for the treatment of manufacturing waste before it is released into the environment. other industries which purchase these pharmaceuticals need to establish higher standards through their supply chains to help correct this environmental pollution (o'neill ). furthermore, the drug companies are not required to compensate victims who become ill or die from either the environmental or food exposure. the drug companies and their trade associations have resisted more regulation to prevent misuse of antibiotics. the companies therefore have been getting a "free ride" at the expense of the ill consumers and the general public. integrators and meat processors. some chains and food retailers have recently responded to customer concerns by restricting the use of antibiotics in their food supply chains. large meat processors committing to judicious use of antibiotics have already led many producers to eliminate the use of antibiotics for production enhancement purposes. in a case study of voluntary labeling in the broiler industry, "raised without antibiotics" (rwa) label claims by tyson foods and by perdue farms in , respectively, numbers one and three in total broiler production, resulted in mixed outcomes. at that time, usda fsis had not published a standard for such claims, nor was a clear definition established. perdue and tyson developed their own standards and submitted the label claims to fsis for approval along with supporting documentation. after initially approving both firms' label claims, fsis determined in september that tyson's claim was false and misleading and gave them the opportunity to submit a revised label claim. however, tyson continued their advertising of the rwa claims. the diverse label claims in which tyson and their competitors were using different standards for their claim resulted in consumer confusion, and eventually court challenges were filed jointly by sanderson farms, the fourth largest producer, and perdue against tyson. the suit was upheld in court in april . tyson was found not to have delivered the rwa attribute promised to the marketplace and to thereby have harmed competitors, while tyson profited from introducing a false and misleading claim. in june , fsis rescinded tyson's qualified rwa label claim and required its removal within weeks, after the claims and advertising had continued for more than a year. the authors found no evidence that the events had any impact on tyson's brand, suggesting that companies may have incentives to introduce misleading label claims since the size of penalties is uncertain (bowman et al. ) . perdue farms inc. was the only major chicken producer to eliminate all medically important and animal-specific antibiotics from use in its chicken production as of . by replacing antibiotics with vaccines and improving its production facilities and practices, it has been able to produce chicken at virtually the same cost as when using antibiotics. perdue estimates that its conventional chicken sales are increasing by not more than % annually, while sales for product raised without antibiotics are growing - % annually (bunge ) . gnp company, a leading provider of premium natural chicken products, is adopting antibiotics-free production of chicken products. its gold'n plump brand will feature a "no antibiotics-ever" claim. this will go well beyond what many companies are currently focusing on-eliminating the use of medically important antibiotics, rather than all antibiotics. usda regulations allow this label claim only for chicken never having received antibiotics, even inside the egg. the company will continue to treat flocks for illness as necessary, but not market them under their premier gold'n plump brand. the company plans extensive media and in-store support to educate consumers about the transition to its chicken products raised totally without antibiotics (gnp company ). tyson foods, a leading producer of chicken, pork, and beef and products thereof, adopted a position to eliminate the use of human-use antibiotics in broiler production by september . they stopped the human antibiotic use in their hatcheries and reduced usage in producing broilers by % since . they also have worked with farmers and others in the beef, pork, and turkey supply chains to explore ways to reduce human antibiotic use at the farm level. tyson is employing alternative husbandry strategies such as use of probiotics and essential oils, improved housing, and selective breeding to offset the potential impact of eliminating the use of the antibiotics. they are also interacting with the food industry and other involved supply chain participants, as well as academics, to increase research on disease prevention and alternatives to replace antibiotics (tyson foods ). feed companies. the feed companies are also getting into the discussion to address public health concerns about antibiotic resistance and the relationship to livestock production uses of antibiotics. phibro animal health corporation recently launched a website animalantibiotics.org to "…provide accurate and credible information while still creating open dialogue about animal agriculture in the use of antibiotics." it will address all issues involving animal antibiotics and changes underway within the industry to promote responsible use of antibiotics in livestock (johansen ) . this is very consistent with the historical pattern of the animal agriculture industry making its case in the political economy in reaction to the strong push to limit use of antibiotics to help quell rising antibiotic resistance of medically important drugs. restaurant chains. an interesting example of restaurant chains and poultry producers working together is provided by panera bread co. and perdue farms inc. panera is one of the restaurant companies for which perdue supplies chickens raised without antibiotics. when panera pioneered antibiotic-free chicken in its restaurant products over years ago, they paid a % premium versus chicken produced using antibiotics. with improved production practices, the cost differential has virtually disappeared (bunge ) and is thus consistent with the ers estimates cited earlier. consumer and other interest groups. in the process of developing these new fda regulations, activist groups petitioned the federal courts. for example, in may , the natural resources defense council (nrdc), center for science in the public interest (cspi), food animal concerns trust (fact), public citizen, and union of concerned scientists (ucs) filed a case against the fda. they charged that fda failed to ban penicillins and tetracyclines used at low doses in animal feed for growth promotion, despite evidence fda put forth in that penicillin and most tetracyclines were not shown to be safe and may pose a risk to human health (apua ). in , the federal court ruled in favor of these petitioners. in a later ruling in , the federal court directed fda to reexamine its decision on five other classes of "medically important drugs" used as growth promoters addressed in two citizen petitions (filed in and ) to ensure the safety and effectiveness of all drugs sold in interstate commerce (ibid). given that most governments have neglected to acknowledge and address the problem of increasing antibiotic resistance, international organizations with a role in health issues have been stymied from doing so. it will take more concerted action by societies around the globe to successfully address this cross-border issue (amábile-cuevas ). us consumers, in general, have much less information about the product than does the seller (chaps. and ). this asymmetric information can offer opportunity for the selling firm behavior that is detrimental to the interests of the consumer, as when a product is labeled as containing or not containing certain desirable or undesirable attributes. in the case of many products known as credence goods, it is impossible to determine whether the attributes are as stated, even when the product is used or consumed. this market failure can be addressed either through government regulations or through voluntary steps by the sellers to assure that the stated attributes are factual. the latter could be accomplished through advertising to build and maintain the firm's brand and reputation, and competition with other sellers could result in consumers having increased variety of product choices. however, some consumers may not trust private companies' word about product attributes and prefer certification programs which monitor products against some standard established either by the private sector or by government agencies. lusk (lusk ) argues that voluntary labels are dynamically efficient in responding to changes in market conditions and encouraging innovation more than mandatory labels implemented through regulations, since the latter are more subject to manipulation by those with vested interests. further, usda's agricultural marketing service (ams) process-verified and certification programs are very effective in helping to assure the credibility of voluntary labeling, while accommodating innovation from the private sector. gnp's adoption of antibiotics-free production discussed in . is an example of dynamic market efficiency through use of voluntary labeling to innovate in response to changing consumer demand usda's food safety inspection service (fsis) currently employs an animal production claims protocol for evaluating and allowing or denying labeling claims. labeling applications must provide supporting documentation such as operational protocols detailing production practices and affidavits or testimonials about production practices. fsis then evaluates whether protocols support the accuracy of the proposed label. also, feed formulations must be provided and reviewed to ensure they do not include substances not permitted by the claim. commonly approved claims relevant to the use of antibiotics include "raised without added hormones" (only allowed for use in beef cattle and lamb production) and "raised without antibiotics." claims not allowed include that animal products are antibiotic-, hormone-, or residue-"free" (fsis ) . given the current trend among meat producers, restaurants, and retail livestock product marketers, it can be anticipated that there will be increasing attention to labeling the lack of antibiotic use for other than therapeutic purposes. this will likely result in animals that have been raised with antibiotics to promote growth and uniformity of size consistent with processor contract agreements being diverted to marketing outlets where such promises do not exist. the impact of labeling in this manner will vary according to how much consumers know about the use of antibiotics in livestock production and their ability to currently purchase antibiotic-free livestock products (lusk et al. ) . o'neill and his british colleagues emphasize improving transparency as a major step in addressing antimicrobial resistance related to the livestock production. recent attention by companies such as food retailers, wholesale producers, and fastfood chains, as well as investors, for reducing antibiotic use in their supply chains, has been in response to consumer pressure. providing greater transparency through voluntary approaches is helpful in the short term, but it may be necessary to mandate transparency requirements about how antibiotics are used in the supply chains to have longer-term impacts. labeling that refers to antibiotic use could improve consumer knowledge to allow them to make better informed decisions. they also argued that third-party validation of support from independent institutions to monitor progress may be beneficial (o'neill ). improved transparency by food producers about antibiotics used in producing meat could help consumers make better informed purchasing decisions. but there are large gaps in data needed to allow monitoring of types and quantities of antibiotics used in animal agriculture and their impacts (cfi ), as well as on emergence and spread of resistance in animals. the who also identified major gaps in surveillance and data sharing on emergence of antibiotic resistance in bacteria and its impact on animal and human health. who called for integrated surveillance systems harmonized across countries to enable better comparison of data from foodproducing animals, food products, and humans (who ). in the united states, fda requires drug companies to voluntarily submit data on drugs sold for use in food animals. the publicly available data are not detailed, and % of the sales of medically important antimicrobials are over-the-counter (otc). tetracyclines are primarily added to feed and accounted for % of domestic sales of animal drugs that are "medically important" to human medicine in (fda b) . from to , domestic sales and distribution of tetracycline products approved for use in food-producing animals increased by %. while levy et al. ( ) discovered how rapidly tetracycline created antibiotic resistance in the gut of chickens, years later, the public does not have access to information on what antibiotics are used in which food animals at what stage of life. this will change somewhat in fda implementation of gfi # (fda ) that will identify whether the sales are intended for use in cattle, sheep, hog, or poultry. fda ( b) issued a final rule amending an existing requirement that sponsors of drug products containing antimicrobial active ingredients report annually the amount of each such ingredient in the drug products sold or distributed for use in food-producing animals. effective july , , drug sponsors were required to submit species-specific estimates of product sales as a percent of their total sales. additional reporting requirements are expected to facilitate better understanding of antimicrobial drug sales for specific food-producing animal species and the relationship between such sales and antimicrobial resistance. as reported above, drug sponsors have all adopted voluntary revision of fda-approved labels for use of new medically important antimicrobial animal drugs administered through feed or water. under this rule, sponsors all voluntarily removed the growth promotion and feed efficiency uses and brought the remaining therapeutic uses under veterinarian oversight by the end of december . the rule makes it illegal to use medically important antibiotics for production purposes. despite the scientific and economic evidence, many comments to the proposed final regulation reflected ongoing resistance to the elimination of food animal production use of medically important antibiotics. data available on antibiotics used in the us livestock industry is derived primarily from two nationally representative surveys of farms conducted by the usda's economic research service (ers) and national agricultural statistics service (nass). the agricultural and resource management survey (arms) is designed to collect information on farm finances, production practices, and resource use focuses on three commodities annually, livestock included. different types of livestock are resurveyed every - years and represent commercial producers in states producing % of production for that livestock type. some questions have been included in these surveys on antibiotic use for hogs and broilers. the hog surveys ask about use of antibiotics in feed or water for growth promotion, disease preven-tion, and/or disease treatment in breeding, nursery, and finishing hogs. given the widespread use of hog production contracts under which farm operators may receive feed from integrators, the surveyed operators may not know if antibiotics are included in it. for broilers, there is only a single question about whether they were raised without antibiotics in feed or water other than for therapeutic treatment of illness. production contracts dominate the broiler industry, so surveyed farm operators are in a similar situation as hog producers in not necessarily knowing whether antibiotics are included in the feed provided. a further complication is that arms does not separate traditional antibiotics and ionophores, which are not used in human medicine (sneeringer et al. ) . the national animal health monitoring system (nahms) consists of national studies to provide essential information on livestock and poultry health and management. major food livestock species are surveyed about every years to provide current and trend information important to industry participants, researchers, and policy makers. each study includes states that represent at least % of the targeted animal population and at least % of the farm operations involved and provides statistically sound information for decision-making. a nahms study is a collaborative, voluntary, confidential, scientifically sound product. descriptive reports are prepared along with information sheets which briefly address very specific topics, such as biosecurity practices (aphis ). the nahms focuses on animal health and management, providing information on disease occurrence and disease prevention practices, as well as more detailed information on antibiotics used in production, including by specific purpose. however, the information collected on antibiotics varies greatly across commodities, as well as over time with the same commodities. further, arms focuses on hog production operations with or more head versus nahms focus on or more head. this complicates comparison of statistics across surveys, assuming smaller operations may have different characteristics than larger ones (sneeringer et al. ) . to track antimicrobial resistance changes over time, the national antimicrobial resistance monitoring system-enteric bacteria (narms) was established by cdc in . the program is a collaboration between state and local public health departments and three federal agencies to monitor changes in antimicrobial susceptibility for certain enteric bacteria from ill people (cdc), retail meats (fda), and food animals (usda) in the united states. it provides information about emergent bacterial resistance, the ways resistance is spread, and how resistant infections differ from susceptible ones (narms ). the world organization for animal health (oie) plans to address antimicrobial resistance as a major risk to the international community, in the face of concern about agriculture's role in increased antimicrobial resistance. the goal is to preserve effectiveness of antimicrobials used in animal medicine, protect animal welfare, and help maintain important antimicrobials for use in human medicine. oie has already developed international standards, most recently revised in . the new strategy introduced at the th oie general session in may outlines plans to help nations improve legal frameworks to preserve antibiotics, communicate about the ar problem, train animal health workers, and monitor antibiotic use in animals. they are currently working to create a database of information on the use of antimicrobial agents in animals and develop performance indicators to assist countries by increasing information flow and transparency in their use of antimicrobials. further, the oie expert network is working to reinforce scientific knowledge about new technologies and replacement solutions for current antimicrobials (mitchell ) . the eu has banned the use of antimicrobials in food animal production, other than by veterinarian prescription for specific therapeutic use. some other countries have adopted similar bans, and, as discussed above, the united states fully implemented voluntary guidelines in requiring current drug sponsors to withdraw antibiotics for growth promotion. however, the animal health institute's carnevale has said that the new fda guidance on antibiotics may not decrease the total quantities of antibiotics used in animal food production (moyer ) . generally, variations among countries in implementing regulations have resulted in the spread of resistance. there is ample evidence to support the need for global coordination to prevent continued spread of antimicrobial resistance, and elements of a framework to make such global coordination effective have been posited (so et al. ) . the uk review on antimicrobial resistance final report proposes three broad steps to deal with reducing unnecessary use of antibiotics in animals. first, establish -year targets for reduction in use, with milestones to support progress consistent with countries' economic development. this could encourage farmers to reduce non-therapeutic use to be able to allocate the resulting reduced amounts of antibiotics to treating sick animals. second, implement restrictions or bans on certain types of highly critical last-line antibiotics for humans from being used in agriculture. this would require a harmonized approach to identify the most important human health antimicrobials across countries and good systems of veterinarian oversight to assure compliance. third, improve transparency from food producers on antibiotic use in meat production to allow consumers to make better informed buying decisions. voluntary industry efforts may be one of the most practical approaches to reduce antibiotic use in the near term, but third-party validation to monitor progress would be beneficial (o'neill ) . generally, voluntary industry approaches require monitoring by an outside party to assure both industry participants and consumers that standards are being met as required. the uk medical research council (mrc) recently made three large grants focused on antimicrobial resistance through an initiative established in to address the growing ar issue. the projects will use new technology to exploit natural compounds, develop a better and faster diagnostics tool, and study how the body's immune system can be harnessed to better fight infections. the goal is not only to develop antibiotics but also explore alternatives to antibiotic use, working with other uk research councils to bring to bear a wide range of disciplines to tackle ar (mrc ). the need to focus increased attention to developing new antibiotics is supported by cdc data which shows that many of the most widely used drugs have developed resistance. the number of years to develop resistance varies greatly but never extends more than a couple of decades, and more recent antibiotic introductions have been resistant for only a year or two. for example, the widely used tetracycline was introduced in and developed resistance to shigella by . this is near the midrange of years to resistance reported (cdc a). given this scientific fact, the slow pace of adopting policies to proscribe use of human-use antibiotics in animals and to encourage greater investment in developing newer antibiotics or alternatives is unacceptable. increasing detection of bacteria resistant to last-resort drugs has driven stakeholders to countenance accelerating government efforts to increase surveillance of drug use and to develop new antibiotics (fda week ). promising approaches which provide more rapid assessment utilizing newer technologies such as genomics are now being utilized by scientists. microbiologists are embracing high-throughput genomics to quickly examine individual organisms or entire microbial communities. a project underway at the university of california, davis, the k foodborne pathogen genome sequencing project, will sequence , foodborne isolates for the most important worldwide foodborne illness outbreak organisms. it involves a consortium of academic, government, and industry to create a massive database of genome signatures for the most significant foodborne disease-causing microbes. the goal is to allow public health agencies and the food industry supply chain to trace any foodborne illness outbreaks to their source. by comparing the pathogen genome to the database which includes millions of pieces of information on previously detected strains, including their exact location, the contamination source will be positively identified. bioinformatics and the analytics involved can be used to turn the vast amount of genomic information into actionable knowledge. these event sequencing approaches will enable new diagnostic and public health approaches to manage foodborne disease to facilitate improved public health. the database will increase ability to detect and mitigate pathogenic organisms in food, the environment, and livestock. that capacity is now constrained by continual genetic evolution of pathogens which hinders the ability to defend the food supply. this project will facilitate speedy testing of raw ingredients and finished products from outbreak investigations with precision and accuracy unparalleled using existing methods of analysis. genomics enabled diagnostics with molecular tools will allow surveillance, risk assessment, and diagnosis of foodborne pathogens directly throughout the global food chain. the result will be a genetic catalog for some of the most important outbreak organisms impacting human health. the database will provide insights into molecular methods of infection and drug resistance for use in creating new vaccines and therapies. and importantly, it will assist in systematic definition of biomarker gene sets associated with antibiotic resistance (weimer ). a recent innovative metagenomics study also provides new insights on possible impacts of antibiotic use in food animal production and ar in humans. the research investigated antimicrobial resistance potential-the resistome-by tracking specific pens of intensively managed cattle from feedlot through slaughter to market-ready beef products. study results found no antibiotic-resistant determinants (ards) in the beef products beyond the slaughter facility. this suggests that intervention during slaughter minimizes potential for antibiotic-resistant determinants passing through the food chain. the results also highlight potential risks through indirect environmental exposures to the feedlot resistome through wastewater runoff, manure application on cropland, and wind-borne particulate matter. the insights provided can be used to better inform future agricultural and public health policy. however, this first of its kind study suggests the scientific community must develop a better understanding of the risk of different resistomes and resistance genes. it also identifies a pressing need to standardize ard nomenclature so that databases and analyses are comparable across studies (noyes et al. ) . the world health organization has recently developed guidelines to mitigate human health consequences from use of medically important antimicrobials in food-producing animals (who ). the guidelines are evidence-based recommendations and include best practices for use of medically important antimicrobials in food-producing animals, especially antimicrobials deemed critically important to human medicine. they also can help preserve effectiveness of antimicrobials for veterinary medicine. the recommendations include: • an overall reduction in use of all classes of medically important antimicrobials in food-producing animals. • complete restriction for use in growth promotion. • complete restriction of use to prevent infectious diseases that have not yet been clinically diagnosed. • antimicrobials designated as critically important for human medicine should not be used to control spread of clinically diagnosed infectious disease identified within a group of food-producing animals, nor for treatment of food-producing animals with a clinically diagnosed infectious disease. • for best practices, any new class of antimicrobials for use in humans will be considered critically important for human medicine unless otherwise categorized by who. further, medically important antimicrobials not currently used in food production should not be so used in the future. these guidelines apply universally, and improved animal health management can be used to reduce the need for antimicrobials including improvements in disease prevention strategies, housing, and husbandry practices as noted in sect . above. economic incentives in regulations were addressed in a recent article. in some european countries, capping total antimicrobial use per animal through regulations has been successful in reducing use by more than half while maintaining competitive livestock sectors. the second option was to impose user fees on veterinary antimicrobials, applied at the point of manufacture or wholesale purchases for imported products, which could also reduce use significantly. as a policy option, some combination of these two strategies would significantly reduce antimicrobial use in food animal production (van boeckel et al. ) . finally, as discussed in chap. , sweden does not allow use of antibiotics in broiler production. if there is the political will, strong regulations can provide strong economic incentives to control antibiotic use. to promote the understanding and implementation of the fda's new veterinary feed directive, the farm foundation and the pew charitable trusts sponsored a series of meetings with livestock and farming communities throughout the united states. twelve educational workshops provided livestock producers, feed suppliers, veterinarians, and support service organizations information and insights on the new policies. the workshops also provided opportunity for participants to interact with fda and usda's animal and plant health inspection service (aphis) personnel about implementation challenges. among livestock producers attending the workshops, small-and medium-sized operators, as well as many veterinarians, were unaware of the pending requirements. lack of understanding about responsibilities under the revised vfd rule means that producers and veterinarians need education. some land grant university extension services are now offering balanced education programs to inform these audiences about their obligations going forward, rather than having interested parties in the food animal industry be the primary source of information to producers and veterinarians about the requirements. while seeing positives of improved public perception and livestock management as result of the new rules, workshop participants were concerned about increased costs in animal health due to restrictions on access to antibiotics and lack of veterinary services. perhaps the biggest challenge is that many small producers do not have established relationships with veterinarians needed to establish a veterinarianclient-patient relationship (vcpr). this may be particularly challenging in remote rural and urban fringe areas where fewer veterinarians are available to treat foodproducing animals. in sum, workshop participants saw a need for education and outreach; continuing dialogue between industry representatives, consumers, and state or federal regulators; and the need to provide better access to veterinary services for food animals. there is widespread agreement that the scientific evidence indicates a global human health and environmental crisis due to antibiotic resistance, in part resulting from production practices in animal agriculture. government action in regulating the animal agriculture industry, to date, has done little to slow the advance of ar. most countries still need to pass legislation to establish appropriate conditions for the import, manufacture, distribution, and use of veterinary products, including antimicrobial agents. continued easy access to antimicrobial drugs for use on the farm is not acceptable. important stakeholders in the animal production industry include pharmaceutical companies, feed companies, livestock production integrators, and some farm groups, each with their own set of incentives and supporters. they must be engaged in the effort to reduce agriculture's role in contributing to development of ar, which cdc estimates at % (fig. . ) . even so, other major industry groups must be engaged to significantly reduce their % contribution to resistance development. in the united states, some progress was made with the passage of the animal drug availability act in and its very gradual implementation through various regulations over the past two decades. however, there are serious gaps in these regulations. given the gridlock that has prevailed in the us congress and the power of the pharmaceutical lobby at the national level, state actions are leading the way to responsive regulation in the public interest. for example, california is the first us state to prohibit all human antibiotic use in food animal production. in contrast to the halting actions of governments and industry, consumer and interest group actions are being at least partially successful in getting fast-food and retail establishments to not market animals fed human-use antibiotics for growthpromoting purposes. this suggests that a productive approach may be finding ways to provide information to and educate consumers about the risks of antibiotic resistance to enable them to make better informed decisions. there is an important role for educators to extend scientific information in a nontechnical way to the lay public. the drive to use antibiotics more responsibly and in the public interest may be facilitated by recent economic results that show that reducing antibiotic use in animal production need not come at a significant economic cost to producers or consumers. since the benefits of using antibiotics for livestock growth promotion appear to have resulted in increasingly smaller productivity gains, independent producers where input mix is a farmer-driven choice based on farm-level economics may be better off to substitute good management practices rather than using antibiotics for prophylactic disease prevention. however, much of meat animal production on us farms is produced under contract, where the integrator provides inputs, often including antibiotics, that the grower is required by contract to use. recent actions by integrators and meat processors to reduce antibiotic use and substitute alternative strategies to protect animals from diseases and maintain productivity are an important development, especially since production-purpose use of antibiotics is now prohibited. presuming that any new human-use antibiotic classes will probably not be made available for veterinary medicine, it is important to preserve the effectiveness of existing antibiotics. some policy makers and industry now recognize the urgency to identify new antibiotics. this will require increased antibiotic research funding and judicious use of existing antibiotics. the ban of human-use antibiotics in animals for production purposes is expected to help slow the growth of antimicrobial resistance, giving more time to discover new antibiotics for animal uses and for human health uses. to the extent they can be developed and used separately, the potential for animal antibiotic use leading to antimicrobial resistance for important human antibiotics will be mitigated. the ban on antibiotics used for humans also being used for animal production purposes will necessitate adopting improved cultural practices to reduce the poten-tial for disease and to increase feed efficiency. this calls for research on best management practices to accommodate today's supply chain requirements for food safety, production efficiency, and attribute verification. moreover, there is a need to educate producers-for example, through the usda-state cooperative extension service-about safe production practices for managing ar. this will allow producers to maintain efficiency in their operations and assure that they comply with current regulations to address the growing concern about antimicrobial resistance in the food supply chain. improved data collection and analysis to allow tracking of potential antimicrobial resistance development are essential to facilitate the food animal industry implementation of cultural practices to reduce the potential for contributing to antimicrobial resistance. it would also allow policy makers to better understand the need for any necessary interventions. these investments in the public good can be very cost-effective, though not without additional public investment or internal agency budget reallocation. increasing international trade may spread antibiotic resistance through imported food products as more trade agreements are approved. this scenario could be exacerbated to the extent fsis approves additional international facilities, local regulations, and inspections as "equivalent to the united states." in many developed and developing countries, antimicrobial agents are readily available. policies need to be implemented establishing appropriate conditions for use of veterinary products, including antimicrobial agents. future trade agreements will need to include provisions which address reduced use of medically important antibiotics in producing food animals. to date, there is no harmonized system of surveillance on the worldwide use and circulation of antimicrobial agents. that information is necessary to monitor and control the origin of medicines, obtain reliable data on imports, trace their circulation, and evaluate the quality of the products in circulation. the oie initiative to create a global database for monitoring the use of antimicrobial agents is an important step that can provide valuable information for private sector and public policy leaders worldwide. the serious implications of growing antibiotic resistance require a concerted effort across all stakeholders and society generally. increased attention to this issue is emerging in the medical community where overuse of existing drugs and inadequate sanitary precautions account for % of the resistance. lack of development of new antibiotics exacerbates the problem, and industry focus and perhaps government policy are needed to improve this situation. animal agriculture stakeholders need to improve production practices to reverse the other % of resistance attributable to foodborne sources. government policy and agencies have been slow to acknowledge the seriousness of antibiotic resistance and appropriately address it. public and private sector collaboration internationally is necessary to successfully deal with this critical societal issue. changes in the measurement of antibiotics and in evaluating their impacts in agroecosystems: a critical review society must seize control of the antibiotics crisis animal and plant health inspection service, united states department of agriculture apua. major developments in u.s. policy on antibiotic use in food animals. alliance for the prudent use of antibiotics farm antibiotic use remains worrisome in india. alliance for the prudent use of antibiotics raised without antibiotics: 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and human services fda announces implementation of gfi # , outlines continuing efforts to address antimicrobial resistance stakeholders: colistin-resistance shows need for congressional action animal production claims: outline of current process. fsis, u.s. department of agriculture gnp company. gold'n plump to add 'no antibiotics-ever' and humane certified attributes. . perishable news.com report of a study: human health risks with the subtherapeutic use of penicillin or tetracyclines in animal feed. committee on human health accurate, credible info on animal antibiotics. phibro animal health report presented to parliament by the secretary of state for social services, the secretary of state for scotland, the minister of agriculture, fisheries and food and the secretary of state for wales by command of her majesty antibiotic resistance in india: drivers and opportunities for action changes in intestinal flora of farm personnel after introduction of a tetracycline-supplemented feed on a farm consumer information and labeling consumer demand for a ban on antibiotic drug use in pork production foregoing sub-therapeutic antibiotics: the impact on broiler grow-out operations pressure rises to stop antibiotics agriculture antibiotic discussions intensify in wdc. pork network world animal health organization sets out action on antibiotic resistance. poultry news the looming threat of factory-farm superbugs mrc announces cross-council awards worth nearly £ m to tackle antibiotic resistance department of health and human services, cdc united states summary and state data the effects on human health of subtherapeutic use of antimicrobial drugs in animal feeds. committee to study the human health effects of subtherapeutic antibiotic use in animal feeds resistome diversity in cattle and the environment decreases during beef production tackling drug-resistant infections globally: final report and recommendations. the review on antimicrobial resistance world organization for animal health merchants of doubt: how a handful of scientists obscured the truth on issues from tobacco smoke to global warming the landscape of antibiotic resistance prepared for united states department of health and human services, public health service, food and drug administration, bureau of veterinary medicine prudent use and regulatory guidelines for veterinary antibiotics-politics or science? economics of antibiotic use in u.s. livestock production an integrated systems approach is needed to ensure the sustainability of antibiotic effectiveness for both humans and animals restricting the use of antibiotics in food-producing animals and its associations with antibiotic resistance in food-producing animals and human beings: a systematic review and meta-analysis economics of antibiotic use in u.s. swine and poultry production position statements: antibiotic use scientific integrity in policymaking: an investigation into the bush administration's misuse of science insights: reducing antimicrobial use in food animals veterinary feed directive a rule by the food and drug administration on / / . illustrative examples of probable transfer of resistance determinants from food animals to humans: streptothricins, glycopeptides, and colistin weimer bc k genome project . veterinary medicine, uc davis antimicrobial resistance: global report on surveillance. summary. world health organization who guidelines on use of medically important antimicrobials in food-producing animals. geneva: world health organization ctx-m- producing salmonella enterica serotypes typhimurium and indiana are prevalent among food-producing animals in china diverse and abundant antibiotic resistance genes in chinese swine farms political economy of biofuel acknowledgments we deeply appreciated the conversations with and review comments from mary ahearn in developing and writing this chapter. any remaining errors, mistakes, or omissions are of course ours. w. j. armbruster and t. roberts key: cord- -qqsmn u authors: caron, rosemary m. title: public health lessons: practicing and teaching public health date: - - journal: preparing the public health workforce doi: . / - - - - _ sha: doc_id: cord_uid: qqsmn u the following four cases represent events that actually occurred at the local, statewide, national, and international levels. a general, succinct overview is provided of each case with references listed should the reader want to access additional resource materials. the concise format of these cases is intended to generate questions. following the general overview of each case, i examine the lessons learned from the practitioner and educator perspective and i list the skills necessary to address the issues in the case. the reader will note that there are skills that are essential for the public health practitioner to master, whether one is in an internship, entry-level position, or the director of a public health organization and so these skills are consistently listed. i encourage the reader to regularly keep abreast of the news locally and abroad and to set aside time before a staff meeting or supervisory group meeting, or use the first few minutes of a class to discuss these issues. ask your workforce or students, “are we ready to handle such an event if it were to occur here?”; “what resources would we need to have accessible?”; “have we partnered with the correct agencies in the community?”; “do we have an established, trusted presence in the community?”; “who else do we need on our team?”; “do we need training in a specialty area, e.g., emergency preparedness?”; “what skills have we mastered and what skills do we need to obtain?” the discussion-based questions are endless but one runs the risk of not being prepared, either individually, or in their agency, should they not discuss how public health events are occurring around us daily. i encourage you to adapt these selected cases to use in your organization and/or classroom. discussing these issues and reviewing the lessons learned will only help us to be better prepared public health practitioners and educators of public health students. prior to the federal ban on lead paint and the housing in the center of this city is of very poor quality (mhd a) . manchester is the most racially and ethnically diverse community in the state. the city's designation as a refugee resettlement community contributes to this richness in diversity. manchester experiences disparity in socioeconomic status and health, similar to other larger urban communities: manchester, new hampshire represents an urban microcosm of the childhood lead poisoning problem. one-third of all childhood lead poisoning cases occur predominantly in the center of this urban community (mhd a; nhdhhs ) . in , . % of children in manchester who had been screened for lead poisoning had eblls, as compared to . % of the new hampshire total (nhdhhs ) . in , approximately % of the leadpoisoned children in the local health department's caseload were refugees or children of refugees. (mhd b) sargent et al. ( ) previously examined clp in urban, suburban, and rural communities in massachusetts and reported that "…those children living in communities with high rates of poverty, single-parent families, and pre- s housing and low rates of home ownership were - times more likely to have lead poisoning" (p. ). the center city of manchester reflects similar demographics and is a community at risk for clp. pediatric fatality: although fatalities due to clp are rare, the first pediatric fatality to occur in over a decade in the usa occurred in this community of manchester, nh. the fatality occurred in a -year-old sudanese refugee child who had resettled in to this community with her mother and siblings from a refugee camp in egypt. the family resided in an apartment in a tenement building that was constructed in the s. approximately weeks following resettlement, this child acquired an ebll of micrograms of lead per deciliter of blood. the cdc's action level in was micrograms per deciliter of blood. hence, this child's ebll was times above cdc's action level at that time. an environmental and epidemiological investigation determined that due to the child's exposure to lead paint dust and chips in the apartment she lived in with her family and her underlying conditions of pica (a craving for nonfood substances) and malnutrition resulted in her acquiring an ebll in a short period of time. the child died as a result of complications triggered by the ebll (caron et al. ) . furthermore, despite the existence of federal regulations developed by the environmental protection agency (epa) that require property owners and managers to provide families with information about lead poisoning and any lead hazards in the home before its sale or lease, the investigation into this case revealed that this information was not communicated in a manner that was understood by the mother of this child (caron et al. ) . lessons learned: this tragic event underscored the need for attention to be paid to those public health problems that persist in the environment, i.e., those issues that the community may live with because there is no feasible solution to completely eliminate the risk. due to the older housing stock in the community that contains lead paint, the cdc named the community and its surrounding towns as a universal screening site. this means that every child at and years of age must be screened for exposure to lead ). this is a form of secondary prevention. the gold standard is primary prevention where exposure to lead would not occur in the first place, thus the risk is removed from the environment. to achieve primary prevention of clp, lead paint would need to be abated from every apartment unit in the city. however, this is a costly process that the municipality or property owners/managers are unable to afford. yet, there are many families with lead-poisoned children who would argue that the benefits of primary prevention outweigh the costs. this case also highlights the complexity of persistent public health problems, such as clp. for instance, this particular family, not unlike other african refugee families, was illiterate in english as well as their own language. in addition, the refugee resettlement process is designed in a declining model of support where the refugees are placed in available housing, which is often of poor quality, and offered health benefits for a limited period of time, and employment is the benchmark of resettlement success not acculturation, good health, or community engagement (caron and tshabangu-soko ) . this community was fortunate in that it already had a functional community coalition that was addressing the problem via policy development, distribution of resources, surveillance, and testing of at-risk children. yet, it is important to consider the multifactorial issues affecting this persistent public health problem in this particular community. selected issues are included below ): • non-english speaking, at-risk population. • public health system that views the problem as complex due to the continuing influx of refugees and the number of agencies involved in refugee resettlement. • multiple stakeholders who view the problem differently and who offer varied, uncoordinated solutions. • intersect of socioeconomic factors, housing policies, cultural practices, english proficiency, and native language literacy. • clp exemplifies the failure of policy development and implementation in the community. • competing demands for food, shelter, clothing, employment for at-risk populations. • exposure results in health effects that are not visible until an ebll is acquired. • providing education in a culturally competent manner. • distrust of community organizations by the at-risk african refugee population. • often, persistent public health problems "…possess no definitive resolutions…" so "…remediation must focus on how to best manage them" (caron and serrell , p. ) . if this tragic event occurred in your community, what questions would you ask? i offer the following questions for you to consider from a practitioner and educator perspective: . how could we prevent children from being poisoned by lead in our community considering that practical solutions are difficult to implement due to the high cost of lead-abatement measures? . are there primary and secondary prevention tools we could implement and evaluate in our community? how will we provide lead prevention education for families for whom english is not their first language? there are over different languages spoken in the manchester, nh, school system (mhd a). it is not feasible to provide translation services for every dialect. how would you educate about a serious public health issue, such as clp, for which there are no visible signs or symptoms until there is an ebll? . does the community have a plan to address this public health issue? has the community, who lives with the issue (i.e., refugees, "working poor"), been invited to participate with public health practitioners? is there a community coalition formed to work on monitoring the issue and connecting families with testing services? how would you establish such a community group if one does not exist? . how would you partner with an academic institution with public health expertise to assist with providing knowledge, expertise, and resources? . how would you partner with the local health-care system (i.e., community health centers, hospitals, physician practices) to assure that they are following cdc testing guidelines and to assist with consistent outreach and prevention education efforts? . are there refugee resettlement services developed by resettled refugees who can assist with contacting an often hard-to-reach population to offer peer education? how would you engage this social service agency? . what data should you be collecting? how will you access these data? who is the "keeper" of the data? how will you conduct surveillance of the public health issue? . what stakeholders in the public health system should be invited to address the problem? if a stakeholder refuses to come to the "table" to work on the issue because they believe the issue is either not under their purview or is too complex to address, how would you engage this key partner? . policies pertaining to lead paint in housing and occupancy vary from state to state. how would you amend the current (if any) lead housing policies in your community or state? would public health enforcement laws be necessary (i.e., citations for property owners who do not comply with the developed policy)? whom would you work with to develop and enact such policies? . this case demonstrates a very tragic, albeit rare, event. with so many competing demands on the public health system, and the fact that clp is a persistent public health problem that the community has lived with for generations, and the costly abatement measures-should clp be in the "top ten" of issues for communities, similar to manchester, nh, to be concerned about? why or why not? . if we addressed clp in the community, what other public health issues could potentially be lessened or mitigated? . how does the refugee resettlement process exacerbate clp? should the refugee resettlement process be redesigned? if so, how? . should communities with refugee children poisoned by lead request a moratorium for refugee resettlement until the community can provide quality housing that does not pose a health risk? what are the implications of a moratorium for the resettled refugees and the community? . how would you engage the refugee resettlement agencies, the social service agencies developed by refugees, and the refugees themselves in a coordinated effort to reduce clp? . how would you know what the newly resettled refugee concerns are and how they compare to their counterparts who have been living in the community for a period of time? the answers to many of these questions may include more resources, more expertise, and more community support. i agree with this assessment. however, often, the public health principles that guide us are challenging to implement "on the ground." clp is a very real issue for this community. the number of refugees affected by this public health problem is influenced by the type of refugee who is resettled in the community. for instance, refugee children of parents who speak english and have a secondary and/or postsecondary education tend to not experience an ebll. this community is not able to request from which country the "newcomers" will arrive. box . highlights selected public health tools that should be utilized by a competent public health workforce addressing clp among a refugee population in their community. these skills are not meant to be exhaustive but are important for public health practitioners and educators of the public health workforce to consider when working on this type of public health problem. • engage the community in the public health issue being addressed. community-based participatory research (cbpr) is one approach to involve the community in addressing the public health issue that they live with on a daily basis. cbpr "…in public health focuses on social, structural, and physical environmental inequities through active involvement of community members, organizational representatives, and researchers in all aspects of the research process. partners contribute their expertise to enhance understanding of a given phenomenon and to integrate the knowledge gained with action to benefit the community involved". (israel et al. , p. ) serrell et al. ( ) previously identified four core values that were important to progress when building community capacity to address clp: "…adaptability, consistency, shared authority, and trust as core values for such partnerships" (p. ). the type of public health professional required to address this specific public health issue includes, but is not limited to, the following: • public health director • environmental health specialist • nurse case manager • build academic-community partnerships based on cbpr principles (see above). these partnerships do not require the presence of a local academic institution but could operate via distance technology so the correct expertise for the specific public health issue is accessed. it is important to note that it can take time to build operational partnerships. • collect data from screening facilities (e.g., local health department, primary care physicians, community health centers). these data may be centralized in a state clp and prevention program. • analyze the data for descriptive purposes to know the demographics of the affected population and the at-risk population. • implement primary prevention via culturally and linguistically appropriate educational methods. • implement secondary prevention via blood screening. assure screening is being conducted by communicating with screening facilities and engaging in medical record audits. • develop policy that will be protective of the resident and places the burden of care on the property owner/manager to abate lead from the dwelling. • consider the community's ecology (i.e., its social, cultural, economic, and political composition) and social context of risk. caron et al. ( ) proposed the following: …that communities are important determinants in health-related problems for refugee populations. each community has its own environment and public health system that interacts with each other to influence health risks and risk perceptions of its populations. (p. ) • partner with others in the public health system (e.g., housing development, refugee resettlement agencies, property managers, etc.) and learn their barriers to the problem, as well as their perception of the public health issue so a feasible and equitable solution or management strategy may be developed. • evaluate progress by reviewing the data to determine whether or not there is a decrease in the number of children poisoned by lead. based on the data, which will tell the story, targeted or tailored approaches for the affected population may be warranted. for example, peer education efforts may be implemented, temporary removal of a family from a home with lead paint until the lead can be removed or covered to meet housing code approval, visual aids for education, nurse case management, environmental inspection of the dwelling, etc. background: "hepatitis c is an infection caused by a virus that attacks the liver and may cause liver damage, liver failure, and even cancer" (nhdhhs , p. ). specifically, hepatitis c arises as a result of a blood-borne infection. for the majority of those infected, the acute phase of the infection is asymptomatic. in addition, for some infected individuals, their immune system will clear the infection. however, there is a risk that many people infected with the hepatitis c virus (hcv) will develop an active, chronic infection and without therapy some will develop liver cirrhosis, liver disease, liver failure, and/or liver cancer (nhdhhs ). the cdc estimates that there are approximately . million people who have been infected with hcv and . million people with active infection in the usa (cdc ): risk factors for acquiring hepatitis c include injection drug use, tattoos with contaminated supplies, use of infected blood products or occupational needlestick injury, transmission during pregnancy, and sexual transmission (which is usually very uncommon). the risk of acquiring hcv from a needlestick injury with blood from an hcv-infected patient is approximately - %, but it depends on the level of virus in the blood and the nature of the injury. (cdc ) hcv can be treated with an antiviral drug regimen that is administered for a period of several months and is quite costly (nhdhhs ). for those who are eligible for therapy and have not been treated in the past, the likelihood of cure is very good in acute infection ( - %). with newer available agents, the response rate is very good in chronic infection as well ( - %). (nhdhhs , p. ) specific to the transmission of hcv in health-care settings, risk factors include the following: . reuse of syringes for more than one patient or to access medication containers used for more than one patient; . sharing of contaminated equipment, like point of care or podiatry equipment; and/or . drug diversion by an infected healthcare worker (hcw). transmission can occur when the infected hcw self-administers an injectable narcotic, intended for patient administration, fills the syringe with saline, and places the used syringe back into the circulation for patient administration. (nhdhhs , p. ) reportable diseases are those that "…hospitals, laboratories, healthcare providers, childcare centers, schools, and local boards of health are required to report diagnosis of certain infectious diseases to dphs" (division of public health services; nhdhhs , p. ): in new hampshire, hcv infection is not in and of itself a reportable disease. however, any suspected outbreak, i.e., the occurrence of illness or disease in a community at a rate clearly in excess of what is normally expected, is reportable to dphs under the mandatory reporting law, part he-p communicable diseases. (nh general court ; nhdhhs , pp. - ) reported infections are investigated by public health nurses and epidemiologists at the new hampshire dphs. the purpose of the investigation is to prevent additional illness in the population, which may be accomplished through a variety of methods, depending on the specific disease. some examples of how public health works to prevent additional illness include identifying close contacts to the infected person and recommending prophylaxis medication to prevent them from becoming ill (antibiotics, antivirals, vaccine, etc.), providing disease prevention recommendations (washing hands, covering cough, etc.), recognizing outbreaks, and identifying and controlling their source (healthcare-associated outbreaks, foodborne outbreaks, etc.). (nhdhhs , pp. - ) investigation overview an outbreak of hcv was identified at exeter hospital in exeter, new hampshire, in . of the initial four patients diagnosed with hcv, one of the individuals was a traveling medical technician in the cardiac catheterization laboratory of the hospital. further investigation by the new hampshire department of health and human services (nhdhhs) revealed that the cause of the outbreak was drug diversion ("…the stealing of narcotic pain medication intended for patients for self use"; nhdhhs , p. ) by the infected medical technician. the testing of potential patients was conducted based on the hospital units to which the medical technician had access, i.e., patients seen in the cardiac catheterization laboratory and those who were patients in the operating room and the intensive care unit. for these areas, patients who had procedures in the cardiac catheterization laboratory during a time period that overlapped the medical technician's time of employment were tested for hcv: of the , who were tested, patients were identified with active hcv infection with the nh hcv outbreak strain. additional patients had evidence of past hcv infection (and their virus could not be tested) and of them were categorized as probable cases (n = ) and suspect cases (n = ) based on epidemiological information. (nhdhhs , p. ) to contact those who were patients in the operating room or intensive care unit during this same time period, nhdhhs partnered with local health departments and clinics to conduct rapid hcv testing on site "…for the first time in an outbreak setting" (nhdhhs , p. ). … , patients were tested and…no additional cases of active hcv infection matching the outbreak strain were identified. additional investigation of other units in . the medical technician worked for a staffing agency that assigned him to different hospitals in seven other states (arizona, georgia, kansas, maryland, michigan, new york, and pennsylvania) over a decade (seelye ). in addition, he had been fired four times over this time span for allegations of drug use and theft (associated press ). thus, the potential for exposure of patients in other states existed and resulted in a multistate outbreak investigation that was conducted by the cdc. "as of may , other cases of the nh hcv outbreak strain were identified and confirmed in two other states (kansas and maryland)" (nhdhhs , p. ). the traveling medical technician pled guilty to "…obtaining controlled substances by fraud… [and] tampering with a consumer product" (fbi ): …he devised a scheme to divert and steal the controlled substance fentanyl for personal use and abuse. fentanyl is a powerful anesthetic intended for patients undergoing medical procedures, among other uses. [he] admitted that he would surreptitiously take syringes of fentanyl prepared for patients, inject himself with the drug, and refill the syringes with saline, causing the syringes to become tainted with his infected blood. he then replaced the tainted syringes for use on unsuspecting patients. consequently, instead of receiving the prescribed dose of fentanyl together with its intended anesthetic effect, patients actually received saline that was tainted with the same strain of hepatitis c carried by [the medical technician]. (fbi ) at the conclusion of the investigation, the nhdhhs ( ) recommended the following action areas: • "increase regulation and improve information sharing regarding allied healthcare workers." • "strengthen healthcare systems to promote prevention and early detection of drug diversion." • "assure optimal response to healthcare associated outbreaks to protect patient safety." (p. ) lastly, as of september , the nhdhhs had partnered with the national association of drug diversion investigators (naddi) in maryland and honoreform, hepatitis outbreaks national organization for reform, a patient advocacy group based in nebraska to influence national policy regarding the regulation of medical technicians (associated press ). any criminal act involving a prescription drug. (national association of drug diversion investigators) inciardi et al. ( ) define prescription drug diversion as the following: …the unlawful channeling of regulated pharmaceuticals from legal sources to the illicit marketplace, and can occur along all points in the drug delivery process, from the original manufacturing site to the wholesale distributor, the physician's office, the retail pharmacy, or the patient. (p. ) in , the cdc declared that the overdose on prescription drugs had reached an epidemic status (cdc a). to further illustrate this point: "in , approximately , unintentional drug overdose deaths occurred in the united states, one death every minutes" (cdc a, p. ). opioid analgesics are responsible for the increase in overdose-related deaths (cdc a). regarding the demographics of the abuse of and deaths from opioid analgesic use, it is …highest among men, persons aged - years, non-hispanic whites, and poor and rural populations. persons who have mental illness are overrepresented among both those who are prescribed opioids and those who overdose on them. (cdc a, p. ) of those who are prescribed opioid analgesics, the populations of greatest concern are those who seek care from multiple physicians and potentially take advantage of the physician's sensitivity to the patient's pain management (cdc a). it is this population that is estimated to not only comprise approximately % of overdose cases on opioid analgesics but also are diverting drugs for self-use or providing them to others (cdc a). thus, the cdc recommends that prevention efforts should focus on addressing the following target populations: patients who consume opioid analgesics in high doses and those who seek care from multiple physicians and receive high doses of opioid analgesics. this latter group is likely to be involved in drug diversion (cdc a). inciardi et al. ( ) report that the primary populations involved in drug diversion include "…drug dealers, friends and relatives, smugglers, pain patients, and the elderly, but these vary by the population being targeted" (p. ). due to the complexity of the issue, several comprehensive prevention strategies have been proposed by the cdc and the american medical association: • restrict the number of reimbursement claims for opioid analgesic prescriptions written by a physician and filled by a pharmacy. this restriction is important for low-income populations on public health insurance, such as medicaid, since this population presents as high risk for drug abuse (cdc a). • monitor that the type and prescribed usage of the opioid medication aligns with the diagnoses (cdc a). • develop and enforce legislation that prohibits "doctor shopping" for those physicians who will prescribe opioid analgesics in high doses; elimination of "pill mills" where controlled pain medicine is distributed with little to no medical oversight; and the requirement of a physical examination prior to receiving a prescription for an opioid (cdc a). • provide medical education via evidence-based practice for general and specialist physicians regarding opioid use and risks, thus holding them accountable for their prescribing practice (cdc a). • fund, at the national level, the national all schedules prescription electronic reporting act (nasper). nasper provides …physicians with up-to-date, patient-specific information at the point of care in order to support appropriate prescribing and to identify those patients who were abusing or diverting prescription drugs. (ama , p. ) nasper was intended to fund prescription drug monitoring programs at the state level (ama ). • develop locations that will take back unused or expired medications (ama ). • expand access to addiction treatment and recovery centers (ama ). • support naddi: …a non-profit organization that facilitates cooperation between law enforcement, healthcare professionals, state regulatory agencies and pharmaceutical manufacturers in the prevention and investigation of prescription drug diversion. (naddi ) lessons learned: if this unfortunate event occurred in your hospital, what questions would you ask? i offer the following questions for you to consider from a practitioner and educator perspective: • how could a medical technician with a suspect record be passed from hospital to hospital? why did the staffing agency not disclose the issues with this employee? did the hospital conduct a thorough background check? • what are our hiring processes? how can we see "red flags" before the individual of concern is hired? who should be involved in the hiring process? • is there a system in place for employees to report suspicious behavior to senior management and human resources? should there be incentives to report employees observed in negligent behavior? • do we have a policy to prevent drug diversion in the workplace? if so, how can we improve the policy? • should we implement mandatory, unannounced drug testing for all hospital employees who engage in patient contact? should termination of employment be implemented if an employee refuses to cooperate with this policy? • is there a reporting system in place so that other hospitals across the country could be notified about the infected individual's reason for termination? • should the penalty for engaging in drug diversion be suspension or removal of one's license or certification to practice their skill in a health-care setting? • what other partners in the public health system should be involved in this issue? how can we partner more effectively with law enforcement and drug rehabilitation centers, for example? • should a public registry for those health-care workers found guilty of drug diversion be created at the national level? should access to such a registry be limited to health-care hiring agencies? should the public also have access to this registry? • how can we do a better job in protecting our patients? • how is drug diversion a public health problem, as well as a health-care problem? box . highlights selected public health tools that should be utilized by a competent public health workforce addressing a hcv outbreak in their community due to drug diversion. these skills are not meant to be exhaustive but are important for public health practitioners and educators of the public health workforce to consider when working on this type of public health problem. • conduct an outbreak investigation. − confirm that there are more cases than expected. − consider whether there is ongoing transmission. − define an outbreak-related case. − confirm existing number of outbreak-related cases. − investigate existing number of outbreak-related cases by reviewing all available data (e.g., medical records, laboratory results, interviews). − determine the infectious period for the outbreak. − determine potential sites of contact in a facility and potential family and others who could be exposed. − determine the exposed cohort of people at each site who may have been present during the case's infectious period. − define the screening action plan (including eligibility, implementation, and follow-up). − create a media plan. − develop and implement recommendations to prevent future outbreaks for particular populations or settings. − evaluate the outbreak response including whether implementations were effective in stopping transmission. − identify lessons learned to prevent future outbreaks (cdc b). • communicate with the affected patients, their families, and the public as soon as the act of negligence is realized. • improve communication between the public health system and the healthcare system professionals. • develop a policy that would serve as safety measures to protect patient populations from health-care workers engaged in drug diversion. examples of such policies could include the establishment of a public registry of health-care workers found to be guilty of drug diversion; mandatory, unannounced drug testing of health-care workers whose employment involves patient contact; coordination of care so the number of physicians prescribing pain medications is limited; continued reporting of mandatory conditions. • collaborate with public health system partners, such as local health departments and law enforcement to assist with drug diversion education initiatives, drug and disease testing, and drug diversion investigations. • support national initiatives, such as nasper and honoreform. • engage in ongoing surveillance of drug diversion in the health-care setting. • educate health-care employees on proper reporting of such adverse events. the type of public health professional required to address this specific public health issue includes, but is not limited to, the following: antibiotic resistance is rising for many different pathogens that are threats to health. if we don't act now, our medicine cabinet will be empty and we won't have the antibiotics we need to save lives. (dr. thomas frieden, director, cdc) overview of public health threat antibiotic use arises from the inappropriate use of antibiotics in humans and animals. for example, with humans, physicians often prescribe an antibiotic when one is not needed and/or the patient does not complete the entire course of antibiotic treatment. thus, "…up to % of all antibiotics prescribed for people are not needed or are not optimally effective as prescribed" (cdc a, p. ). antibiotic resistance can occur both within and outside of health-care facilities, yet deaths related to antibiotic resistance are most common in the healthcare setting (cdc a). furthermore, antibiotics are also commonly used in food animals to prevent, control, and treat disease, and to promote the growth of food-producing animals. the use of antibiotics for promoting growth is not necessary, and the practice should be phased out. (cdc a, p. ) antibiotic resistance is not only a public health problem in the usa but it also presents as a major public health problem on a global scale. the statistics that demonstrate the magnitude of this public health issue on a national scale are staggering: • "each year in the united states, at least million people acquire serious infections with bacteria that are resistant to one or more of the antibiotics designed to treat those infections." • "at least , people die each year as a direct result of these antibiotic-resistant infections." • "many more die from other conditions that were complicated by an antibioticresistant infection." (cdc a, p. ) the cdc states that these figures most likely underestimate the magnitude of the problem since …the distinction between an antibiotic-resistant infection leading directly to death, an antibiotic-resistant infection contributing to a death, and an antibiotic-resistant infection related to, but not directly contributing to a death are usually determined subjectively, especially in the preponderance of cases where patients are hospitalized and have complicated clinical presentations. (cdc a, p. ) thus, these statistics could be significantly higher. moreover, the health-care burden this preventable public health issue creates is multifaceted and can include the following cost-related issues for the health-care system: …prolonged and/or costlier treatments, extend hospital stays, necessitate additional doctor visits and healthcare use, and result in greater disability and death compared with infections that are easily treatable with antibiotics. (cdc a, p. ) these health-care costs are estimated to be in excess of us$ billion and societal costs due to a loss of productivity are estimated to be us$ billion a year (roberts et al. ) . a further complication of antibiotic resistance is seen in those populations who have underlying disease, such as diabetes, asthma, and rheumatoid arthritis. these groups, in addition to those patients who may undergo chemotherapy, organ and bone marrow transplant surgery, joint replacement surgery, or end-stage renal disease are significantly dependent on antibiotic use to fight off infections (cdc a). these subgroups represent a susceptible population to infection especially if antibiotics that are heavily relied upon do not work optimally for these patients. the cdc readily acknowledges the following significant areas of improvement in the body of knowledge regarding antibiotic resistance: • "limited national, state, and federal capacity to detect and respond to urgent and emerging antibiotic resistance threats….we do not have a complete picture of the domestic incidence, prevalence, mortality, and cost of resistance." • "currently, there is no systematic international surveillance of antibiotic resistance threats. today, the international identification of antibiotic resistance threats occurs through domestic importation of novel antibiotic resistance threats or through identification of overseas outbreaks." • "data on antibiotic use in human healthcare and in agriculture are not systematically collected. routine systems of reporting and benchmarking antibiotic use wherever it occurs need to be piloted and scaled nationwide." • "programs to improve antibiotic prescribing are not widely used in the united states. these inpatient and outpatient programs hold great promise for reducing antibiotic resistance threats, improving patient outcomes, and saving healthcare dollars." • "advancing technologies can identify threats much faster than current practice. advanced molecular detection (amd) technologies, which can identify ar [antibiotic resistance] threats much faster than current practice, are not being used as widely as necessary in the united states." (cdc a, p. ) chen et al. ( ) propose that rather than identify population groups at risk for ca-mrsa, diagnostic and preventive approaches should focus on addressing risk factors for ca-mrsa, including "…poor personal hygiene, transmission through contaminated environmental services, and care of non-intact skin" (p. ). ca-mrsa infections typically occur in otherwise healthy people with no recent stay in a health-care facility. in contrast, hospital-acquired mrsa (ha-mrsa) is contracted by patients in a health-care facility and has been attributed to invasive surgical procedures and poor infection control practices (niaid ) . health-care providers are concerned about those ha-mrsa infections that are potentially brought into the community once the patient is discharged (johnson ) . the cdc's report titled antibiotic resistance threats in the united states, , is an excellent resource on this topic and provides a comprehensive overview of specific, ranked antimicrobial resistance threats, including prevention measures. an abbreviated outline of prevention measures for ca-mrsa and ha-mrsa are presented here. the reader is encouraged to review the cdc's report on this topic for more extensive information. at the state and community level, it is important to: • "know resistance trends in your region." • "coordinate local and regional infection tracking and control efforts." • "require facilities to alert each other when transferring patients with any infection." (cdc a) the north carolina department of public health proposes the following core activities for public health professionals to engage in when managing ca-mrsa as a public health threat: • "recognize outbreaks" − for example, "an isolated case on a wrestling team; several cases within the same prison unit in a month; more than one case in a child care classroom in a month" (ncdph ). • "react to community concerns" − "consider the risk factors for transmission; the cs" − "contact (skin-to-skin)" − "contaminated items and surfaces (wrestling mats, weight room equipment)" − "comprised skin integrity (cuts and abrasions)" − "crowding (locker rooms)" − "cleanliness (absence)" (ncdph ) • "respond with public health control measures" − "active surveillance to determine scope of problem in specific setting" − "assure specific control measures for wound care and containment of drainage" − "stop any sharing of personal items and promote enhanced personal hygiene" − "consider exclusion from contact activities, especially with actively draining or packed wounds" − "achieve and maintain a clean environment" (ncdph ) selected examples of actions health-care administrators and providers can take include the following: • "require and strictly enforce cdc guidance for infection detection, prevention, tracking, and reporting." • "make sure your lab can accurately identify infections and alert clinical and infection prevention staff when these bacteria are present." • "prescribe antibiotics wisely." • "remove temporary medical devices such as catheters and ventilators as soon as no longer needed." (cdc a) patients and their family members should: • "ask everyone, including doctors, nurses, other medical staff, and visitors, to wash their hands before touching the patient." • "take antibiotics exactly and only as prescribed." (cdc a) carbapenem-resistant enterobacteriaceae (cre) is a hospital-associated infection that is difficult to treat because the bacteria, normally found in the gut, have become resistant to all antibiotics, including carbapenem, which is often considered a last resort type of antibiotic (cdc c). according to the cdc ( c), …cre infections most commonly occur among patients who are receiving treatment for other conditions. patients whose care requires devices like ventilators (breathing machines), urinary (bladder) catheters, or intravenous (vein) catheters, and patients who are taking long courses of certain antibiotics are most at risk for cre infections. additional risk factors for cre infections include a patient's functional status and a stay in the hospital's intensive care unit (schwaber et al. ) . research conducted by perez et al. ( ) suggests that acute care health facilities could be significant reservoirs for the transmission of cre infections. furthermore, cre infections "…can contribute to death in up to % of patients who become infected" (cdc c). approximately cre infections occur in health-care facilities in the usa. "each year, approximately deaths result from infections caused by the two most common types of cre, carbapenem-resistant klebsiella spp. and carbapenem-resistant e. coli" (cdc a). the incidence of cre infections is on the rise, increasing sevenfold over the past decade (mckinney ). the cdc reports that "about % of u.s. short-stay hospitals had at least one patient with a serious cre infection during the first half of . about % of long-term acute care hospitals had one" (cdc a). the cdc has a comprehensive "detect and protect" program for cre infections. the reader is referred to the following website which provides information about this program (http://www.cdc.gov/hai/pdfs/cre/cdc_ detect protect.pdf). an abbreviated outline of prevention measures for cre infections is presented here: state and local health departments are well positioned to lead cre control efforts because of their expertise in surveillance and prevention and their ability to interact among all the health-care facilities in their jurisdiction. (jacob et al. , p. ) thus, at the state and community level it is important to: • "know cre trends in your region"; • "coordinate regional cre tracking and control efforts in areas with cre. areas not yet affected by cre infections can be proactive in cre prevention efforts"; • "require facilities to alert each other when transferring patients with any infection"; • "consider including cre infections on your state's notifiable diseases list". (cdc a) selected examples of actions health-care administrators and providers can take include the following: • "require and strictly enforce cdc guidance for cre detection, prevention, tracking, and reporting"; • "make sure your lab can accurately identify cre and alert clinical and infection prevention staff when these bacteria are present"; • "know if patients with cre are hospitalized at your facility, and stay aware of cre infection risks. ask if your patients have received medical care somewhere else, including another country"; • "follow infection control recommendations with every patient, using contact precautions for patients with cre. whenever possible, dedicate rooms, equipment, and staff to cre patients"; • "prescribe antibiotics wisely"; • "remove temporary medical devices as soon as possible." (cdc a) • "tell your doctor if you have been hospitalized in another facility or country"; • "take antibiotics only as prescribed"; • "insist that everyone wash their hands before touching you." (cdc a). [to address antibiotic resistance] "…will require expanded and coordinated action from clinicians, facility administrators, and public health officials." (jacob ) guh et al. ( ) reported that of state health departments surveyed, all perceived emerging infections, such as cre, as a public health priority for prevention. yet, the extent to which these states can engage in prevention-oriented activities depends upon available resources and existing partnerships among their agencies, hospital administrators, and others in the public health and health-care systems. the cdc has developed core actions to help prevent the development of antibiotic resistance: • "preventing infections, preventing the spread of resistance"; • "tracking"; • "improving antibiotic prescribing/stewardship"; • "developing new drugs and diagnostic tests." (cdc a, p. ) lessons learned the main question is how do we, as public health practitioners and educators, work collaboratively with our partners in the health-care system to prevent antibiotic resistance in the health-care setting and the community? building upon the public health action plan set forth by the cdc, box . highlights selected approaches and tools to prevent infections, broaden our surveillance approach, and improve antibiotic stewardship. these skills are not meant to be exhaustive but are important for public health practitioners and educators of the public health workforce to consider when working on this type of public health problem. • cdc has several surveillance programs to monitor antibiotic resistance trends in the community: • "cdc's national healthcare safety network (nhsn) is used by healthcare facilities to electronically report infections, antibiotic use, and resistance" (cdc , p. ). the more hospitals that report to this database will enable cdc to track the level of antibiotic resistance in all bacteria, as well as track antibiotic usage. "this information will allow facilities to target areas of concern, to make needed improvements and to track the success of their efforts" (cdc a). • "cdc manages the get smart program [http://www.cdc.gov/getsmart], a national campaign to improve antibiotic prescribing and use in both outpatient and inpatient settings" (cdc a, p. ). "one core activity is the development and implementation of the antibiotic stewardship drivers the type of public health professional required to address this specific public health issue includes, but is not limited to, the following: , a tool that provides healthcare facilities with a menu of interventions they can select from to improve antibiotic use" (cdc a, p. ). • "stewardship is a commitment to always use antibiotics only when they are necessary to treat, and in some cases prevent disease; to choose the right antibiotics; and to administer them in the right way in every case. effective stewardship ensures that every patient gets the maximum benefit from the antibiotics, avoids unnecessary harm from allergic reactions and side effects, and helps preserve the life-saving potential of these drugs for the future." (cdc a, p. ) • "…new antibiotics will always be needed to keep up with resistant bacteria as well as new diagnostic tests to track the development of resistance". (cdc a, p. ) and is believed to be spread via direct transmission. the case fatality rate is high in that approximately half of the people with the mers-cov infection have died. "however, the virus has not shown to spread in a sustained way in communities. the situation is still evolving" (cdc the severe acute respiratory syndrome (sars) pandemic was short lived but certainly tested the preparedness of our public health and health-care systems for a never-before-seen virus that was transmissible from animals to humans. mers-cov possesses some similarities to sars in that both are believed to be evolved from the bat coronavirus, affect the lower respiratory system, and are transmitted via an airborne route (breban et al. ). however, recent research has also indicated significant differences between these two coronaviruses. for example, assiri et al. ( ) reported that patients diagnosed with mers-cov tended to be older men with underlying chronic medical conditions, including diabetes, heart disease, and renal disease. in addition, these researchers noted that the progression to respiratory failure occurred faster compared to sars (zumla ) . furthermore, these authors observed, in contrast to sars, which was much more infectious especially in healthcare settings and affected the healthier and the younger age group, mers appears to be more deadly with % of patients with co-existing chronic illnesses dying, compared with the % toll of sars. (zumla ) lastly, the authors note that it is possible we are only detecting the most serious of the mers-cov cases, and there are milder cases going undetected in the community (zumla ) . it is these milder cases that also require a case definition: ultimately the key will be to identify the source of mers infection, predisposing factors for susceptibility to infection, and the predictive factors for poor outcome. meanwhile infection control measures within hospitals seem to work. (zumla ) public health emergency? although this is a new virus with a high case fatality rate and is of great concern to the public health and health-care communities, the world health organization (who)'s emergency committee of the international health regulations [unanimously decided in july ] …that with the information now available, and using a risk-assessment approach, the conditions for a public health emergency of international concern (pheic) have not at present been met. (who ) "while not considering the events currently to constitute a pheic, members of the committee did offer technical advice for consideration by who and member states on a broad range of issues, including the following: • improvements in surveillance, lab capacity, contact tracing and serological investigation • infection prevention and control and clinical management • travel-related guidance • risk communications • research studies (epidemiological, clinical and animal) • improved data collection and the need to ensure full and timely reporting of all confirmed and probable cases of mers-cov to who…." (who ) furthermore, there are no current travel bans to countries that have reported mers-cov cases. cdc's …travel notice is a watch (level ) which advises travelers to countries in or near the arabian peninsula to follow standard precautions, such as hand washing and avoiding contact with people who are ill. (cdc ) similarly, who does not currently propose any travel or trade restrictions or special screening activities at points of entry into countries (hopp ) . public health preparedness cdc is actively monitoring the outbreak of mers-cov cases and working with international public health partners. to date, cdc has engaged in public health preparedness for this new virus in the following ways: • "…developed molecular diagnostics that will allow scientists to accurately identify mers cases." • "…providing mers-cov testing kits to state health departments." • "…developed interim guidance for preventing mers-cov from spreading in homes and communities to help protect people if there is ever a case of mers in the u.s." • "…offering recommendations to travelers when needed. cdc is also helping to assess ill travelers returning from affected areas." • "…provide advice and laboratory diagnostic support to countries in the arabian peninsula and surrounding region." (cdc ) research by breban et al. ( ) examined the transmissibility of mers-cov between humans which allowed them to estimate the potential for mers-cov to attain a pandemic status. the authors concluded "…that mers cov does not yet have pandemic potential" (breban et al. , p. ) . the authors recommend the following public health actions: "…enhanced surveillance, active contact tracing, and vigorous searches for the mers-cov animal hosts and transmission routes to human beings" (breban et al. , p. ) . knowledge gaps since this outbreak is still evolving, there are many gaps in our knowledge about the epidemiology of the infection, its clinical course, best diagnostic tools, patient management, and infection control. assiri et al. ( ) did an outstanding job in formulating the questions the public health and health-care communities should be addressing. i have highlighted a few of these questions here for discussion purposes. the reader is referred to the descriptive study of mers-cov in saudi arabia that was conducted by assiri et al. ( ) for further probing questions. • "what is the natural reservoir of mers-cov?" • "what is the source of exposure to mers-cov outside of the healthcare facility (e.g., animals, water, sewage, food)?" the type of public health professional required to address this specific public health issue includes, but is not limited to, the following: asymptomatic, mild, severe infection)?" • "what is the infection rate in the community?" • "what are the protective immune system mechanisms against mers-cov?" • "what is the excretion pattern of the virus?" • "what is the best clinical management of mers-cov?" • "is there a role for antiviral agents?" • "how stable is mers-cov under different environmental conditions (e.g., dry surface, in vomit, sputum or diarrhea)?" • "how can we efficiently disinfect against mers-cov?" • "is there a role for herd immunity against mers-cov? public health skills to address a novel disease outbreak • collaborate with public health partners at the local, state, federal, and international levels in the case of mers-cov, public health and health-care professionals and researchers are reviewing the similarities and differences between sars and mers-cov. reviewing how similar outbreaks were managed can help steer a similar • participate in videoconferences and conference calls sponsored by the cdc and who regarding the latest information and best practices pertaining to the epidemiology, prevention guidelines, clinical management engage in diligent surveillance activities to help develop prevention methods specific to your local community • evaluate these prevention efforts and adapt as necessary. • document the approaches implemented and their effectiveness as this may inform evidence-based practice for future disease outbreaks • be prepared, to the extent possible, with sufficient material and personnel resources to plan, respond, and evaluate prevention efforts inform and educate the public about their risk and prevention efforts via media outlets outbreaks of novel diseases can be unpredictable as the virus evolves. be prepared for changes in transmission, the target population, and disease management references local public health case: pediatric fatality in a refugee resettlement community agency for toxic substances disease registry case studies in environmental medicine: lead toxicity community ecology and capacity: keys to progressing the environmental communication of wicked problems environmental inequality: childhood lead poisoning as an inadvertent consequence of the refugee resettlement process fatal pediatric lead poisoning childhood lead poisoning in a somali refugee resettlement community in new hampshire accessed sept. city of manchester, new hampshire health department (mhd) lead poisoning among refugee children resettled in massachusetts review of community-based research: assessing partnership approaches to improve public health new hampshire childhood lead poisoning prevention program: - blood lead level screening data childhood lead poisoning in massachusetts communities: its association with sociodemographic and housing characteristics an academic-community outreach partnership: building relationships and capacity to address childhood lead poisoning combating rx diversion, overdose and death-comprehensive public health strategies needed after hepatitis c probe, nh, groups push for better drug diversion prevention, detection core elements of an outbreak investigation former employee of exeter hospital pleads guilty to charges related to multi-state hepatitis c outbreak mechanisms of prescription drug diversion among drug-involved club-and street-based populations national association of drug diversion investigators new hampshire code of administrative rules new hampshire division of public health services, department of health and human services national public health case: antibiotic resistance centers of disease control and prevention community-acquired methicillin-resistant staphylococcus aureus skin and soft tissue infections: management and prevention. current infectious disease reporting assessment of public health perspectives on responding to an emerging pathogen: carbapenem-resistant enterobacteriaceae vital signs: carbapenem-resistant enterobacteriaceae hospital mrsa infections fall by more than %, report shows superbug a 'triple threat' but cdc issues warning early to prevent spread north carolina public health management of ca-mrsa carbapenem-resistant acinetobacter baumannii and klebsiella pneumoniae across a hospital system: impact of post-acute care facilities on dissemination hospital and societal costs of antimicrobialresistant infections in a chicago teaching hospital: implications for antibiotic stewardship predictors of carbapenem-resistant klebsiella pneumoniae acquisition among hospitalized adults and effect of acquisition on mortality international public health case: middle east respiratory syndrome-coronavirus epidemiological, demographic, and clinical characteristics of cases of middle east respiratory syndrome coronavirus disease from saudi arabia: a descriptive study. the lancet infectious diseases interhuman transmissibility of middle east respiratory syndrome coronavirus: estimation of pandemic risk middle east respiratory syndrome coronavirus (mers-cov) who statement on the second meeting of the ihr emergency committee concerning mers-cov fullest clinical report of saudi mers points to important differences with sars cases to date key: cord- -y g ceq authors: affolder, rebecca; zaffran, michel; lob-levyt, julian title: global immunization challenge: progress and opportunities date: - - journal: maternal and child health doi: . /b _ sha: doc_id: cord_uid: y g ceq after reading this chapter and answering the discussion questions that follow, you should be able to: outline important milestones in the emergence of vaccines as a means of disease control and prevention. discuss factors that underpin the disparity in access to vaccines between rich and poor countries. identify and appraise innovative options for financing vaccine development, and for ensuring wider access to new and underused vaccines in developing countries. evaluate strategies for ensuring sustainability in vaccine development, management, and access. outline priorities for future research, policy, and practice with regard to vaccine development, procurement, and access. vaccines, having been developed over the last years to become one of the most cost-effective and successful public health interventions, are one of the most exciting technologies in the world today. yet every year, around . million children die from diseases that can be prevented by currently available or new vaccines. vaccines have the potential to erase some of the most glaring global health inequities which currently shape the lives of millions. often the most vulnerable -women, children, and adolescents in even the poorest countries, could be protected against life-threatening and debilitating disease within a generation. this chapter presents a historical perspective on the emergence of vaccines as a means of disease control and prevention over the past two centuries. beginning with discov- inequity in access to vaccines between rich and poor countries and the underpinning factors are discussed, including lack of safety and quality assurance systems in poor countries, focus of research and development on rich nations' priorities, and the diversion of scarce resources to other emerging global health priorities. various innovative options for financing wider access to new and underused vaccines in poor countries are explored, including the role of the international finance facility for immunization (iffim), the advanced market commitment (amcs), the heavily indebted poor countries (hipci) and multilateral debt relief (mdri) initiatives, and the debt buy-down program of the world bank. issues of sustainability in vaccine development, procurement, and management are discussed as are priorities for future research, policy, and practice. the first immunization -and the origin of a smallpox vaccine -is believed to have been in (table . ) when british physician edward jenner administered fluid from a cowpox lesion obtained from a milkmaid named sarah nelmes andre ( ) ; plotkin ( ) to a -year-old boy named james phipps. jenner later found that the boy was ''secure'' to smallpox virus (andre ) . louis pasteur later coined the term vaccine in reference to the latin word for cow: vacca. records of a similar medical approach can be found in chinese literature dating back to the eleventh century and linked with the fight against the smallpox virus (plotkin ) . according to the national library of medicine (u.s. national library of medicine ), the practice of variolation, where small scabs of tissue containing smallpox were inhaled causing the individual to contract the disease in a mild form, reduced the mortality rate among those exposed to the disease to - % as opposed to % when individuals contracted the disease naturally. by , the practice of variolation as a response to smallpox had expanded to india, africa, and throughout the ottoman empire. variolation was first practiced in europe by and, by , in the american colonies (u.s. national library of medicine ). the immunization field grew in the th and th centuries, with major breakthroughs in the mid-to late th century through discovery of vaccines that protect against such diseases as influenza, polio, and yellow fever (table . ) . prior to the development of such vaccines, the loss of life from disease is illustrated in some staggering figures. for example, the influenza (or ''spanish flu'') outbreak of - resulted in more deaths than enemy fire in world war i (plotkin ) . the period of - can be considered a second phase in the history of immunization. the world health organization (who) launched the expanded program on immunization (epi) in , expanding the smallpox eradication effort which was focused on one single vaccine into an infant program of six vaccines (against diphtheria, pertussis, tetanus, poliomyelitis, measles, and tuberculosis). at the time, less than % of the world's children were immunized against these six diseases. meanwhile, an increased degree of population mobility, for example, through commercial air travel, helped bring about the recognition that infectious disease prevention required a coordinated, global effort. the epi launch marked an important turning point: immunization became an international public good. in response to a world health assembly challenge (world health assembly ), immunization coverage rose over the next decade, with the united nations children's fund (uni-cef) declaring % of the world's children under the age of immunized against tuberculosis, polio, and measles by (hardon and blume ) . a number of global initiatives contributed to the progression of immunization coverage rates in the s. unicef, with the support of other international organizations, launched the ' 'child survival revolution'' in (unicef . this initiative comprised four interventions for reducing mortality: growth monitoring, oral rehydration, breastfeeding, and immunization (gobi). at the same time, who led major vertical programs to combat vaccine-preventable disease, diarrhea, and acute respiratory infections (hardon and blume ) . the universal childhood immunization (uci) goal was launched in to catalyze efforts toward universal immunization coverage. uci aimed at accelerating epi, capitalizing on the success in mobilizing support. as a result of these dedicated efforts, child mortality declined in many countries (hardon and blume ) . yet, despite the overall success of accelerating immunization coverage in the period described above, significant disparities are apparent ( fig. . ). the expansion in coverage was largely in developed countries with large populations. one hundred and seven countries did not reach the immunization coverage of %, and the declaration of success did not reflect the uneven coverage within many countries -where some of the most vulnerable children in hard-to-reach areas were missed. a great success for some masked the growing divide in access between north and south. the characteristics of the north/south divide, which remains the current global situation, developed during the s. a gap in the routine immunization schedules for children in developed and developing countries emerged as new vaccines, including those for hepatitis b, haemophilus influenzae b (hib), varicella, pneumococcal, meningococcal, and combination formulations became a routine part of the immunization schedule for children and adolescents in high-income countries (hardon and blume ) . research and development priorities favored those products targeting developed countries. vaccine quality and safety, taken for granted in many countries with robust regulatory agencies, fell behind in many countries lacking an effective quality assurance program for medical products. quality and safety issues also point to the weakness of health delivery systems in many poor countries which limited the effective rollout of routine immunization. the gap in financial commitment to maternal and child healthwhich underpins and drives the north/south divide in access to immunization -widened over the s as scarce resources were diverted to other emerging global health priorities. many developing countries struggled to improve or even maintain their immunization rates. the end of the decade saw an overall decline in global immunization and vaccine production, and particularly among the poorest populations in the poorest parts of the world. the new millennium set the stage for a major shift in the global response to the growing inequities between north and south. under the leadership of the then un secretary general kofi annan, the un millennium summit, the largest-ever gathering of world leaders, was convened at the united nations headquarters in new york, usa, in september (united nations development program . at the close of the summit, world leaders unanimously adopted the ''united nations millennium declaration'' taking on a clear obligation to act through commitment to the millennium development goals (mdgs) (united nations ) . these goal comprised a set of time-bound and measurable goals and targets for combating poverty, hunger, disease, illiteracy, environmental degradation, and discrimination against women. corresponding financial commitments from the developed world in the form of aid, trade, debt relief, and investment were made at the international conference on financing for development in monterrey, mexico (ifad ). as part of a renewed commitment to poverty reduction and human development, the international community moved to address the growing inequalities in immunization and the unacceptable toll of infectious disease in developing countries. marking the start of a ''third phase'' in the history of immunization, the global alliance for vaccines and immunization (now the gavi alliance) was launched in january to accelerate access to new and underused vaccines in the poorest countries. gavi, an innovative public/private partnership, brought together the major stakeholders in immunization in order to achieve global immunization targets. these stakeholders included national governments, unicef, who, the world bank, the bill and melinda gates foundation, the vaccine industry, public health institutions, and nongovernmental organizations (gavi alliance a). soon after gavi's launch its mandate came to include action on the child mortality target of the millennium development goals -namely, a / reduction of the under- mortality rate by (gavi alliance b). in the years since gavi's launch, overall dtp coverage increased from % in to % in in gavi-eligible countries, i.e., those with a gross national income (gni) of less - than $ , per capita. the figures are more pronounced in the who african region where dtp coverage increased from % ( ) to % ( ) and has overtaken southeast asia ( % in ), which is now the region with most unimmunized children (who b) . much of this increase in dtp coverage has been attributed, through independent evaluation, to the immunization services support provided by gavi to strengthen immunization delivery systems and infrastructure (lu et al. ) . in terms of new and underused vaccine introduction, the cumulative achievement of the poorest countries to improve coverage is impressive (gavi alliance b). over years, . million additional children were immunized against hepb ( ) ( ) ( ) ( ) ( ) ( ) . four and a half million additional children were immunized against yellow fever in , equaling a cumulative . million additional children immunized over years against yellow fever. an additional . million additional children were immunized with hib vaccine in , equaling a cumulative . million additional children immunized with hib vaccine over years. critical to these improvements has been the ability of the gavi alliance to raise new and additional resources -providing funds to introduce new and underused vaccines, improve injection safety, improve immunization delivery services, and strengthen health systems. gavi-supported countries are continuing to produce impressive results (gavi alliance a). despite the exciting results, we must not lose sight that the key challenges remain gaining better data on disease burden to stimulate demand and ensuring the affordability and long-term sustainability of new vaccine introduction. until prices become more affordable, slow uptake of new vaccines in the poorest countries remains inevitable. how this challenge can be better addressed through innovative approaches is covered in the discussion on funding challenges below. the gavi alliance is but one element of a growing complexity of agencies working on maternal and child health issues; while it maintains a niche focus, this requires close collaboration with partners in the broader global health community. the launch of the global immunization vision and strategy (givs) in (who/unicef ) provided a critical overarching framework that exhibits the need for coordinated mix of instruments and approaches. these approaches may be in the form of highly successful vertical campaign strategies for the global eradication of polio and control of measles, delivery of basic vaccines in conflict environments, or in the longer-term efforts to create sustainable markets for new and underused vaccines in the poorest countries. givs was approved by the member states of who and the executive board of unicef in . it sets out a plan to address the global immunization challenges over the decade - and strives to act with equity and gender equality, in addition to personal ownership, partnership, and responsibility. placing immunization firmly within the health system strengthening agenda, givs ''aims to sustain existing levels of vaccine coverage, extend immunization services to those who are currently unreached and to age groups beyond infancy, introduce new vaccines and technologies, and link immunization with the delivery of other health interventions and the overall development of the health sector'' (who/ unicef ). the vision and goals of givs are a world in that highly values immunization and that has equal access to immunizations for all. this world would also support sustainable interventions in diverse social situations, changing demographics and economies, as well as being a world that will put vaccines to the best global health and security use. addressing the key challenges: funding, sustainability, equity following the launch of givs in , a who/ unicef study examined the cost, financing, and impact of immunization programs in the poorest countries (who/unicef ). implementation of givs would protect more than million children in the world's poorest countries against the major childhood diseases by . the estimated total price tag for immunization activities for - in these countries is us $ billion, one-third of which would be spent on vaccines and two-thirds of which would be spent on immunization delivery systems. the study concluded that spending on immunization will need to rise from us $ . billion per year ( ) to us $ . billion by and us $ billion by (who/unicef ) . national budgets will ultimately fund vaccines and health services. the challenge will be to grow and sustain financing from domestic resources. how will the poorest countries reach this point? donor funding in the interim and the growth of poor economies will determine the ability of countries to finance their health sectors. to illustrate the additional sums required, it is worth noting that the report of the commission for africa ( ) recommended that donors spend around % of the commission's proposed us $ billion package for africa to strengthen health systems and ensure a satisfactory response to hiv and aids by . this call for additional spending is supported by analysis which shows that many countries will be able to work within a substantially increased spending envelope for health (foster ). yet donor aid remains volatile. in health, the shortcomings of traditional aid -from poor allocation to an absence of a results-focused, coordinated effort among donors -have clearly, if not tragically, been illustrated over the last decades (radelet and levine ) . innovative financing mechanisms provide a way to overcome some of the current limitations of aid while mitigating the political risks that many donors associate with significantly scaling up finance to developing countries, for example, through transfers such as budget support. global funds and partnerships such as gavi have shown that innovative solutions to development challenges, including raising additional finance for development, can be generated by bringing together public and private stakeholders, including the civil society. gavi provides the leverage so that both donor and developing country governments can employ new and innovative funding strategies -such as performance-based grants and co-financing (long-term subsidy agreements) for new vaccines -which characterize gavi as an instrument for innovative financing. while it is too early to make any conclusive statement on the long-term market-shaping impact of gavi, an independent study states that ''emerging suppliers view the gavi market as attractive and credibility-building, with the added economic advantage of alignment with domestic or middle-income markets. this is thanks to the significant size and growth of gavi, as well as the price levels it has provided'' (boston consulting group ) . as a catalyst for further innovation in finance, gavi has had a critical role in developing two further mechanisms for financing vaccine introduction and development: the international finance facility for immunization (iffim) and advance market commitments (amcs). the iffim, launched in , is a pilot of the larger international finance facility (iff) that was originally proposed by the government of the united kingdom in to double global aid for development and to accelerate the availability of funds through the gavi alliance in of the poorest countries around the world. the mechanism takes long term ( years), legally binding commitments from donors (iffim ) and borrows against them for years in the capital markets, producing upfront finance and thus stabilizing a portion of aid flow to developing countries. because of the innovative ''frontloading'' funding program, an anticipated iffim investment of us $ billion is expected to prevent million child deaths between and and more than million future adult deaths from hepatitis b-related liver disease. advance market commitments (amcs) provide legally binding promises, usually offered by governments or other financial entities, to guarantee a viable market if a vaccine is successfully developed. this ensures revenues will be generated from the newly developed vaccine that will match those of other comparable medicines. amcs speed the development of new vaccines by enabling biotech and pharmaceutical companies to successfully invest in vaccine development (iavi ) . beyond the clear benefit of providing long-term, predictable finance to countries, allowing them to make longer-term budgeting and planning decisions, the predictable funding for immunization through iffim has the potential to leverage significant market benefits by allowing bulk purchasing of vaccines. the predictability and legally binding nature of the financial commitment provides strengthened negotiating power and the ability to negotiate longer-term arrangements with suppliers, generating lower prices and therefore more vaccines for the same envelope of funds. a second market-shaping innovative mechanism -an ''advance market commitment'' (amc) pilot for a pneumococcal vaccine -was launched in february . an amc is a financial commitment to subsidize the future purchase, up to a pre-agreed price, of a currently unavailable vaccine -if an appropriate vaccine is developed and providing the demand exists when the vaccine is finally produced. by guaranteeing that the funds will be available to purchase vaccines once they are developed and produced, the amc mimics a secure vaccine market and takes away the risk that countries will not be able to afford a high-priority vaccine, addressing current market failure: vaccines that would prevent millions of deaths facing long delays before they are developed, tested, and produced for use in the poorest developing countries. by establishing a valuable market, amcs provide incentives for private investment in the development of vaccines against neglected diseases. such a ''pull mechanism'' is not an alternative, but is highly complementary to other public and philanthropic interventions in the health sector and, more generally, in development aid. amcs will be most effective when combined with push interventions because of the network effects of the increased number of scientific researchers working on the target diseases as well as the enhanced probability that scientific research swiftly translates into the production of effective and safe vaccines. push interventions include public and philanthropic funding of research through academia, public-private partnerships, and other bodies. the private resources mobilized by successful amcs would act in synergy with initiatives to expand immunization (e.g., gavi and iffim) and strengthen health systems. the success to date of raising funds through innovative financing instruments will continue to catalyze more thinking on both innovative means for raising and delivering development aid and how to better align these new instruments with more traditional aid streams. debt relief is an emerging area in innovative financing for health which could usefully be applied to accelerate sustainable vaccine introduction. the two major broad initiatives for debt relief are the heavily indebted poor countries initiative (hipc) and multilateral debt relief initiative (mdri) programs. the hipc initiative was launched by the international monetary fund (imf) and the world bank in and aims to reduce debt for heavily indebted poor countries that face unsustainable debt burdens, that are pursuing reform programs, and that have developed a poverty reduction strategy paper. the hipc estimates providing debt assistance in the amount of us $ billion dollars in debt relief, funded by bilateral creditors and multilateral lenders, to a total of countries ( taking the hipc a step further, the multilateral debt relief initiative (mdri) was launched by the group of eight industrialized countries (g ) in and will provide % cancellation of debt owed by hipcs to the international development association (ida), to the african development fund (afdf), and to the imf (international monetary fund, b) . this program enacts up-front, irrevocable debt cancellation for eligible countries (table . ). the main objective of the mdri is to enable hipcs to mobilize funding for poverty reduction programs in order to reach the millennium development goals. the intent is that additional resources made available through debt relief should be allocated to poverty alleviation programs. but as there is no formal obligation to allocate resources relieved by the mdri to any specific sector, competition between departments for the use of these extra resources is likely. potential impact of the mdri on health system strengthening and on financing immunization programs could be significant. as annual amounts of debt service relief will be significant in many hipcs, especially around - , a small percentage of these resources could have a reasonable impact on the health sector and in particular on immunization financing. the gavi alliance partners are currently exploring options for using debt relief -in the form of an international development association (ida) buy-down -to specifically support countries' vaccine programs. in addition, a number of bilateral debt relief programs may also offer an opportunity for targeted debt relief. ida buy-downs are currently being explored as new innovative financing mechanisms for vaccines. ida is member of the world bank group. it provides long-term loans (also called concessional loans or credits) and grants to the poorest of the developing countries, particularly those that are severely constrained by conflict, epidemics, and debt. a buy-down refers to a third party paying off all or part of a specific ida credit on behalf of the government upon successful achievement of pre-determined performance indicators. the world bank began an ida buy-down pilot in , when it provided the governments of nigeria and pakistan with roughly $ million in ida credits for the purchase of vaccine to help achieve the global polio eradication objective. the bill and melinda gates foundation, rotary international, and the united nations foundation agreed to pay off the ida credits upon successful achievement of the performance indicators, in this case receipt and distribution of vaccine and specified polio immunization coverage levels. innovative financing, while not a magic bullet, will nonetheless offer a range of new possibilities for countries to help reach the significant increases in finance required to meet the mdgs. ultimately, the real test will be whether the donor community is successful in working together to ensure traditional aid is aligned to a mixed instrument approach. this has been done before. bangladesh, one of the poorest countries in the world, has achieved the most radical improvements in reproductive health the world has ever seen. this has impacted significantly on women's and child mortality and morbidity, their social status and economic growth -despite poverty, poor governance, political upheaval, and an apparent lack of any potential for economic growth in the early years. the key was that for years from the mid- s, through a mixture of aid instruments, donors and multilateral agencies provided substantial, predictable but coordinated financial and technical support for salaries, a radical expansion in the workforce (notably paramedics), associated infrastructure, and ''expensive'' reproductive commodities which the government delivered through state and civil society structures. it has become clear that new technologies such as vaccines or antiretrovirals (arvs) for hiv have the potential to deliver a generational leap in achieving the mdgs. the health gains made in europe over years could be achieved in africa over a - year period (who/unicef ). of the more than million annual child deaths, an estimated % could be avoided through immunization with existing and newly developed vaccines such as pneumococcal and rotavirus vaccines. procurement of essential health commodities is an area where this can be carried forward without risk to macroeconomic stability. yet without basic health systemsessential for the sustainable availability of medical products -the poor will never access these benefits. despite evidence of the cost-effectiveness of vaccines in particular and the economic and social benefits of health in general, the track record of national and donor budget allocations to date is not good. gavi-eligible countries have very modest health budgets, with government health spending across africa, for instance, averaging $ -$ per capita and with many countries below $ . responding to the needs of poor countries by investing in the critical foundation for the delivery of basic health services requires a long-term view. while vertical approaches have been effective at raising the profile and funding levels for vaccines, countries must now be supported to move systematically to introducing the full range of vaccines in immunization programs as part of integrated maternal and child health services. with expensive new vaccines coming to market (for example, three doses each of pentavalent (dtp-hepb-hib), rotavirus, and pneumococcal conjugate vaccines could amount to more than us $ per child) it is clearly no longer appropriate to focus on financial sustainability of a single product in isolation from broader system sustainability. moving toward a truly sustainable planning framework will not be a simple endeavor, yet it represents an exciting opportunity for the gavi alliance partners. one challenge will be to gather the information on demand and future prices required by countries to inform longer-term planning and decision making. unicef's commitment and global procurement ability over the years has brought great benefits in terms of quality, security, and better prices for such long established vaccines as bcg, dpt, measles, and polio. but it has become clear that this procurement model is most effective in mature markets with overcapacity and competition, and notably capacity in countries located in emerging markets (e.g., india, brazil, indonesia, and cuba). new or combination vaccines such as dtp-hepb-hib challenge the established means of procurement, where cost limits the ability of donors to deliver affordable products to the poorest parts of the world. it is only through competition that the prices of new vaccines will become affordable to the poorest countries. clearly the key to success will be the ability to mobilize additional donor funds, but to use those funds in such a way that the vaccine market is shaped to promote competition and to bring prices within reach of the poorest countries. beginning in , gavi support shifted toward national co-financing (as opposed to gavi providing vaccines free). this is based on the intent by the gavi alliance partners to ensure that gavi financial support is seen by all stakeholders as time limited and to ensure that countries move to a fuller ownership of their immunization program, including the introduction of new vaccines. co-financing therefore aims at supporting and stimulating evidence-based priority-setting within the immunization program and within the health sector more generally. financial commitments, however small, also generally require a higher level of government engagement. through this approach, which will be evaluated in , gavi alliance partners are working to help countries to be on a trajectory of eventual independence from gavi support, acknowledging, however, that, for most of the gavi-eligible countries this is likely to require a very long time over the next decade, the ability of developing countries to achieve sustainable introduction of new technologies will be largely dependent on how donor funds are provided, particularly whether there is a shift toward long-term, predictable aid and if innovative financing instruments are appropriately aligned and taken to scale. the other key determinant will be sustained political support for health and for vaccines by developing country governments. guyana is an example of a country that has been highly successful in achieving high immunization coverage and is the first gavi-supported country to fully finance the purchase of pentavalent vaccine from its national budget (united nations ). guyana's continuing success is in part due to a very strong political commitment at the highest levels to finance the national immunization program, including efforts to protect it from economic shocks and shifts in donor priorities. more broadly, there has been a remarkable growth in the health budget from us $ . per capita in to us $ in (excluding overseas development assistance). this accounts for % of national expenditure, while the government's goal is to reach % (ministry of health, guyana ; editorial, pharmacoeconomics and outcomes news, ) . from an equity point of view, gavi's condition of support to the ministry of health, china, was that vaccines be made available at no cost (removing the previous charge). this policy was subsequently adopted across china for all vaccines. while the spread of hiv and aids has led to recent discourse on health as a global security issue, most arguments -and certainly those related to maternal and child health -have at their root the principle of equity and the belief that health is a basic human right. equity in health has been defined (for measurement and operationalization) as ''the absence of systematic disparities in health (or in the major social determinants of health) between groups with different levels of underlying social advantage/disadvantage -that is wealth, power or prestige'' (braveman and gruskin ) . the world development report, making services work for poor people, noted that ''the concern for equity is either a social choice or based on the notion that health is a human right'' (world bank ) . as an ethical or social justice issue, equity in health is therefore a critical element for consideration and measurement, particularly when looking at the trade-offs and choices made around financial sustainability issues discussed in the previous section. many of the disparities in health result from social determinants such as poverty, access to services, education, gender, and ethnicity. harnessing the potential of new medical technologies, such as vaccines, to reach underserved groups will take concerted effort and in some cases, explicitly defined political choices. new vaccines against human papilloma virus (hpv) provide the opportunity for such a political choice: to ensure that all women, rather than just those in wealthy countries, are provided with a vaccine that will prevent most cervical cancer cases. hpv vaccines, as the first vaccines to focus primarily on women's health, provide the global health community an unprecedented opportunity to tackle a key neglected women's health issue -one which especially impacts on the poorest women. cervical cancer is not difficult to prevent; yet, it affects an estimated , women each year and leads to more than , deaths (ferlay et al. ) . it is largely a disease of poor women who have limited access to health services; about % of women dying from cervical cancer live in developing countries (fig. . ) (ferlay et al. ) . the lack of effective cervical cancer prevention interventions -part of a regular medical checkup for women in wealthy countries -is a major factor in the high rates of cervical cancer among poor women. if current trends in women's health continue, there are projected to be over , , new cases of hpv annually by the year (boyle ) . many challenges must be addressed before hpv vaccine can reach the millions of girls and young women who would benefit from it, especially those living in the developing world where the need is greatest. with the right combination of scientific, educational, and financing efforts, hpv vaccine could become available globally within a few years. accelerating access to hpv vaccine could make cervical cancer -the second most common cancer among women worldwide -a rarity in just a few decades. another social determinant of health is where one lives. within large developing countries, such as india, nigeria, or china, there are significant inequities in the population's health. disparities in access to, and utilization of, services within these countries are often a result of factors such as geography, social barriers, conflict, and weak governance. of the million children that missed out of immunization in more than % live in countries (fig. . ). india and nigeria stand out as countries with the largest number of unimmunized children in the world. reaching mdg will thus require a significant increase in investment in immunization -both domestic and external -in countries with large numbers of unimmunized children who account for more than half of all vaccine-preventable deaths among children less than years of age. with some states or regions in some of these countries being equal or larger in population to many countries, a fresh state-or region-based approach will likely be required, with a focus on the poorest. for example, child and maternal mortality rates in the poorest eastern provinces of china equal or exceed those found in much of africa (world bank ) . despite economic growth, equity is worsening. national political commitment in such countries will be key. a program approach, tailored to country-specific challenges, will be required. additional long-term finance (domestic and global) will be critical to support that political commitment. new technology, including new and better vaccines, will be vital. which vaccines for the future? research and development for vaccines and other essential health commodities point to another disparity between north and south and constitute a market failure. priorities in the global allocation of resources for vaccine research and development do not match the global burden of death and disease. few resources are allocated to tackling diseases that disproportionately affect people in developing countries; new vaccines are therefore expensive and out of the reach of the poor. this discrepancy between need and reality is illustrated in table . , illustrating that normal market mechanisms do not work for the poor. among the vaccines currently under development, the three most needed today in terms of their potential public health impact are for aids, tb, and malaria. jointly, these diseases account for over million deaths per year or around % et al. ( ) of all infectious disease deaths. the total investment in vaccines against these diseases is far lower than their importance as dictated by disease burden and it will probably take at least - years before a vaccine against any of these diseases is available. in the past two decades, advances in biotechnology have resulted in the licensure of new vaccines such as hib, acellular pertussis, hepb, and attenuated varicella. most of the basic scientific breakthroughs have been generated in research institutions in the public sector whereas the cost for clinical development is borne by the pharmaceutical industry. this requires heavy investments that need to be recouped from profits. the markets needed to recoup these investments are in industrialized countries that can afford to buy. the evolving disease burden in developing countries will bring new diseases into prominence while sometimes allowing old ones to resurface. this will influence priorities for vaccine research (table . ). the severe acute respiratory syndrome (sars) epidemic, the outbreak of avian influenza, and the emergence of bioterrorism threats such as anthrax have led to new research avenues for vaccines against these infections. the threat of a reassorted influenza pandemic virus strain has highlighted the need for more resources and attention to the development and distribution of effective flu vaccines. alternative administration routes for vaccines would greatly contribute to improving immunization program safety and potentially reduce the quantity of contaminated waste which needs to be safely disposed. this could help avoid needle transmission of blood-borne pathogens and ease vaccine delivery strategies where non-professionals can administer vaccines. new administration routes such as oral, nasal, and transcutaneous are currently being explored. one option currently being explored through collaboration by who, path, and the serum institute of india is focusing on the development of a measles aerosol vaccine that could make a big difference in eliminating this disease by facilitating administration, during mass campaigns (burger et al. ) . the measles aerosol vaccine is useful in situations where the availability of trained medical personnel, who can safely administer injections, is limited. immunogenically in studies, the aerosol vaccine was proven effective > % of the time among infants < months of age and - % among infants > months and school-aged children (henao ) . this vaccine continues to be tested in clinical trials in order to find the most appropriate and effective aerosol delivery method. another interesting option is the concept of using plant-derived or edible vaccines that involve encoding protective antigens from pathogens into transgenic plants (mor et al. ). the plants are processed so that they can deliver a uniform dose of vaccines. human clinical trials have been conducted with bananas and raw potatoes, which showed encouraging antibody responses (sala et al. ) . plant-derived vaccines are formed when a gene is integrated with a plant nucleus or chloroplast genome. this transforms higher plants (e.g., tobacco, potato, tomato, and banana) into bioreactors for the production of subunit vaccines for oral or parental administration (sala et al. ). the potential advantage of this technology could include thermostability, low investment needs, multivalency, and oral administration. new technologies that strengthen vaccine delivery are under development. priority is given to such technologies that will (a) expand access, (b) improve safety, and (c) cut the cost of immunization programs. they include the following five technologies: (i) ''sharps'' processing: the increased use of autodisable (ad) syringes (syringes which lock themselves after a single injection) has greatly improved the safety of immunization programs by avoiding the reuse of contaminated syringes and reducing risks of transmission of blood-borne pathogens such as hepatitis b, hepatitis c, and hiv (lloyd ) . this success is, however, highlighting another problem which the health sector is facing, that of the handling of contaminated medical waste. in the case of immunization, this is mainly related to the disposal of used syringes and needles (these syringes represent between and % of all injections given in the health sector but nevertheless the push to introduce ad syringes is increasing the pressure on immunization programs to tackle this challenge). sharps are rarely disposed of at the point of use. since sharps are transported to the point of destruction, the risk of infection from accidental exposure to sharps must be minimized. four different technologies are being explored for this purpose: corrosive disinfectants, thermoprocessing, needle destruction, and plastic melting (lloyd ) . however, none of these options is currently sufficiently developed to be put into use in the field. (ii) monodose pre-filled devices: vaccine wastage constitutes a considerable cost to immunization programs. monodose presentations eliminate wastage and the risk of contamination. when the monodose is pre-filled into an injection device, it increases quality and safety at the point of use. uniject is one such device that has been tested with hepb and tetanus toxoid (tt) (lloyd ) . village health workers can administer it. currently, major obstacles reside in the cost of the device and the need for additional cold storage space when multidose presentation is exchanged for monodose, but ultimately, the objective would be to provide an increasing number of immunizations with monodose preparations that would not require increased cold chain capacity. (iii) needle-free injections: needle-free injectors deliver vaccine at high velocity into the skin without penetration of a needle, thereby reducing the risk of transmission of blood-borne pathogens (who c) . technologies are being developed for both mono-and multidose presentations. multidose injectors available have not been found safe and new models are under development. there are several monodose models available; however, they are not feasible for large-scale programs because of regulatory obstacles and high cost (who ) . (iv) thermostable vaccine: vaccine distribution and storage without a cold chain would considerably simplify the delivery system, reduce cost, and allow for integrated supply mechanisms. removal of vaccines from the cold chain should be the highest priority for technology research. sugar glass drying is one such technology that has shown great promise (lloyd ) . it can be used to produce multivalent vaccines that are completely heat stable, except under extreme climatic conditions. the high cost of regulation/licensing and the uncertainty about market prospects in industrialized countries have so far impeded the development and use of this technology. vaccines are delicate products that are easily destroyed if handled incorrectly. vaccine management spans a spectrum of aspects involving the use and disposal of vaccines, from the manufacturers to the end-users, for which plans must be in place and regularly updated to ensure an effective and efficient service delivery including (i) inventory and forecasting; (ii) stock control; (iii) in-country distribution; (iv) storing and handling; (v) equipment replacement; (vi) procedures for the use of vaccine; (vii) monitoring of vaccine storage; (viii) transport management; and (ix) operational management. all of these areas would benefit significantly from research efforts to find alternative and innovative approaches. for instance, the heavy reliance on the cold chain remains a major economic and logistical burden on programs. the possibility of taking greater advantage of the real thermostability of vaccines and the increasing use of the vaccine vial monitor by taking vaccines ''out of the cold chain'' is a field which has only begun but could potentially revolutionize immunization delivery (table . ) . vaccine vial monitors are heat-sensitive circular labels, no wider than a centimeter, that change color as vaccines are exposed to heat. they are time-temperature indicators used to (i) ensure that the vaccines have not been damaged by excessive exposure to heat, (ii) identify weaknesses in the cold chain, and (iii) take vaccines beyond the cold chain to reach out to children who have no access to fixed health facilities. health workers can use the vaccine vial monitor color to tell if the vaccine has been overexposed to heat and whether or not it is safe for immunization. this indicator cuts down on the uncertainty of vaccine safety due to potential temperature changes during transport along the cold chain. therefore, the vaccine vial monitor reduces waste. immunization remains one of the most cost-effective of all public health interventions. maternal and child health-related mdgs will be difficult to meet without significantly scaling up the coverage of existing vaccines and successfully introducing new pipeline products -ensuring that research and development priorities are aligned with the diseases for which preventative technologies are needed most. financing this effort, however, poses a considerable challenge. a serious commitment to closing the north/south divide and meeting mdgs will require a joint approach that involves increased investment by developing country governments and better, more stable aid flows from donors. increased investment, particularly in the social sector, will be critical to finance costs such as system building that require large amounts of sustained finance. in-kind investments in commodities can be scaled up rapidly without major concerns around absorptive capacity or macroeconomic stability. long-term, predictable aid flows are also needed to reduce volatility and provide increased certainty over future budget flows to enable better planning in countries. as a global community, we must start approaching our work from a perspective that evaluates who is taking on the burden of risk -it clearly should not be the poorest countries. risk analysis is a common tool in the private sector -companies only take decisions based on the probable level of risk it implies for them. yet the donor community consistently places the poorest countries in a position where it is very difficult for them to make choices of how or whether to radically scale up access to basic services. the donor community, including the gavi alliance and the international financial institutions, needs to develop strategies to reduce financial and political risks. this means adjusting processes and requirements to support the long-term integrated plans of developing countries. the financial risks of development strategies must be more equitably shared between donors and national governments. development will be led by developing countries when they are enabled to plan ahead; what factors account for the disparity in immunization coverage between developed and less developed countries? . what is the gavi alliance? how does its mission compare with those of global immunization vision strategy what major barriers confront the gavi alliance and givs in their efforts to ensure equity in access to new and underused vaccines in developed and less developed countries? in a narrative of about , words, describe the meaning and mission of the following initiatives: a. international finance facility for immunization advance market commitments (amcs) how successful are iffms and amcs in accomplishing their mission? vaccinology: past achievements, present roadblocks, and future promises global vaccine supply: the changing role of suppliers cervical cancer prevention: current situation. eurogin international expert meeting on hpv infection and cervical cancer prevention defining equity in health stabilizing formulations for inhalable powders of live-attenuated measles virus vaccine developing countries are providing cofinance for life-saving vaccines fiscal space and sustainability: towards a solution for the health sector. high level forum on health mdgs unfinished agendas and mixed results an overview of aerosol immunization, meeting of the who steering committee on new delivery systems international fund for agricultural development (ifad) ( ) international conference on financing for development -statement by lennart ba˚ge, president of ifad advance market commitments: helping to accelerate aids vaccine development debt relief under heavily indebted poor countries (hipc) initiative the multilateral debt relief initiative (mdri) benin: third review under the three-year arrangement under the poverty reduction growth facility, request for waiver of nonobservance of a performance criterion, and request for extension of the arrangement technologies for vaccine delivery in the st century effect of the global alliance for vaccines and immunization on diphtheria, tetanus, and pertussis vaccine coverage: an independent assessment guyana financial immunization sustainability plan . brickdam, georgetown: ministry of health/ministry of finance perspective: edible vaccines -a concept coming of age why certain vaccines have been delayed or not developed at all can we build a better mousetrap? three new institutions designed to improve aid effectiveness vaccine antigen production in transgenic plants: strategies, gene constructs, and perspectives. vaccines united nations children's fund (unicef) ( ) the state of the world's children : the s: campaign for child survival human development report: millennium development goals: a compact among nations to end human poverty developing countries join gavi alliance and who to ''co-finance'' vaccines for poor children the world development report -making services work for poor people china's progress toward the health mdgs proceedings of the first global vaccine research forum traditional medicine. the fifty-sixth world health assembly (wha . ) geneva: world health organization china immunises millions of children against hepatitis b in historic collaboration between government and gavi alliance united nations children's fund (unicef) ( ) global immunization strategy who ivb human papillomavirus & hpv vaccines: technical information for policy-makers and health professionals world health organization (who) ( b) who report on gavi progress world health organization (who) ( c) immunization safety for ensuring sustainability in procurement, access, and uptake of vaccines in less developed countries. what are the major barriers? . what should be the priorities for future vaccine research and development globally? provide justification for your position. key: cord- -lrgj gxd authors: renda, andrea; castro, rosa title: towards stronger eu governance of health threats after the covid- pandemic date: - - journal: nan doi: . /err. . sha: doc_id: cord_uid: lrgj gxd nan in just a few months, covid- a disease caused by a novel coronavirus known as sars-cov- appeared in china and quickly spread to the rest of the world, including europe and the usa. with confirmed cases surpassing . million, reported deaths approaching , and dramatic projections for the next months, many governments are now facing tragic choices, such as imposing harsh containment and quarantine rules, while a few are betting on "herd immunity" by letting the virus spread widely (this latter strategy was initially announced and later abandoned by the uk, while it is being adopted to a certain extent in the netherlands and sweden ). healthcare workers have been constrained to choose which patients to save and which ones to let die, and professional health societies have been prompted to issue guidance for these hard choices. in a triumph of path dependency, most european union (eu) member states have taken gradual, sparse and inconsistent steps, such as closing intra-eu borders and limiting the free circulation of medical devices and protective equipment. all of a sudden, the eua project that took decades to buildis on the verge of collapse; trust between countries is declining, while trust between citizens is surprisingly on the rise. fear of the unknown is leading citizens around the world to look for the solidarity of their neighbours and gradually lose interest in what happens across the border, in what economists and historians have already started to term "de-globalisation". investors witness the most dramatic nosedive in the recent history of stock exchange indexes and market operators start preparing for the worst economic crisis since world war ii. in this article, we argue that the pandemic was predictable, and yet the level of preparedness shown by countries around the world, including most advanced economies, was wildly insufficient. for what concerns the eu, more coordinated action would have been desirable and has also been sought by the european commission; however, such attempts arrived too late, and were hampered by fragmented governance, as well as by the lack of an eu-wide risk and crisis management framework. while many have rushed to describe the outbreak as a "black swan" an unpredictable event with extremely severe consequences such as the financial crisis, the dot.com bubble or / we have argued elsewhere that covid- was not only predictable ex post but it was amply predicted ex ante. unlike the typical "black swan" event, there is no evidence that the sars-cov- virus was human-made. more importantly, an outbreak of pandemic dimensions was widely predicted beforehand. the threat of such a pandemic was to be expected, yet it was ignored, despite repeated warnings by experts, the press and expert groups such as the report of the "high-level panel on the global response to health crises", which warned about the need to address existing gaps and "enhance global capacity to rapidly detect and respond to health crises"; as well as the global preparedness monitoring board (an independent monitoring and accountability body be/professioneel/nieuws-professioneel/ethical-principles-concerning-proportionality-of-critical-care-during-the-covid- -pandemic-advice-by-the-belgian-society-of-ic-medicine>. see h james, "a pandemic of deglobalization", project syndicate, february <https://www.projectsyndicate.org/commentary/covid- -deglobalization-pandemic-by-harold-james- - >. <https://www.bloomberg.com/news/articles/ - - /sequoia-capital-warns-startups-of-coronavirus-blackswan-event>. a renda and rj castro, "chronicle of a pandemic foretold", ceps policy insights no - /march . kg andersen, a rambaut, wi lipkin, ec holmes and rf garry, "the proximal origin of sars-cov- " ( ) nature medicine <https://doi.org/ . /s - - - >. l garrett. "the next pandemic?" ( ) foreign affairs , observing that "highly virulent, highly transmissible pandemic influenza that circulates the world repeatedly for more than a year" would end up killing more people than all the known weapons of mass destruction "save, perhaps, a thermonuclear exchange". <https://time.com/ /next-global-security>; <https://hbr.org/ / /the-world-needs-a-darpa-styleproject-to-prevent-pandemics>. protecting humanity from future health crises. report of the high-level panel on the global response to health crises <https://digitallibrary.un.org/record/ ?ln=en>. to ensure preparedness for global health crises, hosted by the world health organization (who)), which concluded that "the world is not prepared for a fast-moving, virulent respiratory pathogen pandemic". a simulation exercise in the usa in october confirmed "major unmet global vulnerabilities and international system challenges posed by pandemics that will require new robust forms of public-private cooperation", and around the same time, the global health security index report reiterated this warning. very useful lessons could be learned through several epidemics that occurred over the past decades (sars, h n and ebola). and indeed, some of the countries that were most exposed to those pandemics, especially in south-east asia, have shown an enhanced level of preparedness compared to many others. however, the pandemic has clearly exposed the lack of preparedness at global, eu and national levels. these gaps are now threatening many peoples' lives, healthcare systems, the world economy and even the future of the eu. the who has worked extensively on pandemic preparedness, adapting its strategy to the lessons learned from past outbreaks such as hiv, ebola, h n and sars. the global framework for preparedness for global health emergencies is based on the binding who international health regulations (ihr ). however, important gaps have been identified both at the level of who governance (eg funding, lack of coordination between headquarters and regional offices and lack of transparency and accountability), as well as at the level of national implementation of the ihr. while a joint external evaluation framework exists for countries to assess their national capacities within the ihr, only countries in the wider european region (which comprises countries) have submitted their reports, while five others are preparing to do so. for example, to date, no report is available for italy, france or spain. the ebola crisis had already evidenced gaps in funding, health system capacities and reporting. it also unveiled the unnecessary and uncoordinated use of travel bans, trade restrictions and quarantines. in addition, the who director general was also accused of waiting too long before declaring a public health emergency of international concern (pheic), which only happened around four months after the ebola outbreak global preparedness monitoring board, "a world at risk", annual report on global preparedness for health emergencies, september <https://apps.who.int/gpmb/assets/annual_report/gpmb_annualreport_ .pdf>. spread internationally. importantly, public budget cuts imposed after the financial crisis ( ) were reportedly part of the problem. other problems that emerged in the case of ebola included the absence of sufficient incentives for coordinating research and development activities and important gaps in information and data sharing between institutions, in particular for the coordination of non-pharmaceutical interventions (including quarantines, social gathering restrictions or cordon sanitaire). in the case of covid- , a worldwide race has emerged to develop new therapies, vaccines and diagnostic tests, although the ultimate availability and affordability of such technologies would still need to be figured out. however, a limit in worldwide and even pan-european data sharing has persisted and manifested itself on an even larger scale. iv. eu mechanisms to deal with pandemics: high expectations, a peculiarity of covid- is that it is not only affecting countries with structural deficiencies in their healthcare systems, but also countries that normally have wellfunctioning and well-funded healthcare systems, including eu member states such as france, italy and spain. according to the treaty on the functioning of the european union (tfeu), the eu has a shared competence with member states in public health matters for aspects defined by the treaty. article tfeu calls the eu to act on global health issues by fostering cooperation with third countries and competent international organisations; however, it also establishes that the responsibility of organising their health systems remains in the hands of member states. the eu decision on serious cross-border threats to health provides the framework for eu action related to crisis preparedness and responses to cross-border health threats, including the early warning and response system (ewrs) and a health security committee (hsc), which coordinates responses to outbreaks and pandemics, both within and outside the eu. a dedicated agencythe european centre for disease prevention and control (ecdc)was set up in an attempt to strengthen europe's response capability and to provide technical support to member states. the ecdc is in charge of the surveillance, detection and risk assessment of threats, epidemiological surveillance and the operation of the ewrs. consensus on the need for an agency emerged after the sars outbreak in , and the ecdc became operational already in . its work was found to be relevant and meaningful in a recent external evaluation, which particularly praised the relevance of the centre's activities during the zika and ebola outbreaks. however, the same document also reported weaknesses "in the centre's ibid. capacity to adapt to changes in the member states, particularly reduced national public health spending"; and that the centre has not been able to adequately cover its staff costs and hire additional staff. most worrying is the reported lack of adequate cooperation by member states, in particular in the epidemic intelligence information system (epis) and the european surveillance system (tessy), a situation now also aggravated by the effects of brexit. in spite of having a legally binding instrument (the eu decision on serious crossborder threats to health) and a dedicated agency (the ecdc), the eu governance framework remains a work in progress. this is critical for cross-border health threats, the quintessential case calling for harmonisation and coordinated action superseding national borders. significant gaps remain on the implementation of the eu decision on serious cross-border threats to health, and the eu framework remains highly limited by the need to respect the competences of eu member states. the main coordinating agencythe ecdcis also understaffed and under-budgeted. moreover, several aspects will require enhanced attention if the eu wants to improve its preparedness and responsiveness in light of future pandemics. first, early warning and prevention strategies need to be better integrated with responses. especially for zoonoses (diseases spreading from animals to humans), collaboration between the animal health and human health sectors is critical. because many pandemics, including the one caused by sars-cov- , are zoonoses, prevention strategies need to emphasise cross-sectorial collaborations under an integrated one health approach. while the current eu approach coordinated by the ecdc is inspired by such an integrated one health approach, lack of resources and limited information exchange hamper early warnings of diseases at the intersection of animal and human health. second, limiting eu competences on public health is highly inefficient during a pandemic response. during the current outbreak, the ecdc has issued recommendations, including on the criteria for discharging covid- patients, social distancing and contact tracing. the european commission also published recommendations for testing strategies. binding on eu member states, and national authorities are currently deciding who to test, whether or not to trace contacts and how often and what types of social distancing measures to adopt. while clearly the adoption of severe measures such as quarantines, school closures and suspension of economic activities often needs to be adapted at national or even regional and local levels, there is also a need for coordinating measures to contain or mitigate the spread of communicable diseases. both the intended and unintended effects of such measures in any one member state may have important consequences in others (especially at the border). for instance, early announcements of lockdowns in some cities or countries have prompted a large number of people to flee from severely affected areas, possibly aggravating an already difficult situation. closing some activities in one member state while leaving them open in others also had similar effects. third, data sharing is key to understanding the evolution of an outbreak and adapting measures as needed. while the ecdc has competences to collect and share data, one important limitation that emerged during the covid- outbreak is the lack of consistency across data. while eu member states are sharing data, in many circumstances the level of quality and detail varies significantly. for example, not all countries are sharing data on the number of cases by age and sex. and key information such as the criteria adopted for testing, which have a direct effect on the number of confirmed cases and deaths reported, was not fully shared, which also fostered a lack of trust between member states. all of these factors have so far limited the ability of eu institutions to learn in real time from data at the eu level, thereby limiting the eu's ability to respond to the pandemic. global rules (the who ihr of ) and eu coordination (the eu decision on crossborder threats to health and the ecdc) are two elements in setting up a coordinated response plan. an effective approach to prepare and respond to pandemics also needs to rely on strong national institutions. in , a study found many gaps in member states' legislation, and a staggering lack of available and transparent information about national frameworks, in spite of clear information-sharing obligations set up at eu and global levels. against this backdrop, eu member states have been reluctant to invest in measures to tackle low-risk, high-consequence occurrences. in a world dominated by the quest for economic efficiency, with financial markets ready to award a premium to governments <https://www.theguardian.com/world/ /mar/ /leaked-coronavirus-plan-to-quarantine- m-sparks-chaosin-italy>. reducing public spending and thereby taxes, there is little place for resilience-orientated policy. the resulting paradox is that those events that scare citizens the most are tackled by many politicians with a macabre taste for risk. in europe, the financial crisis led many member states to impose drastic spending cuts on healthcare in almost every country. evidence of cutbacks and "an overall declining share of health expenditure going to public health" in the post-financial crisis period has been recently reported. for instance, the organisation for economic co-operation and development (oecd) reported that following the economic crisis, health investments per capita in italy decreased until and only started to increase very slowly after then. to capture the capacity of eu healthcare systems to respond to a crisis, the eu commission and the oecd have developed a series of indicators reflecting on the long-term stability of resources and efficient and strong governance responses, including to plan and forecast healthcare infrastructure and workforce. given the rigidity of most public spending on healthcare, cuts inevitably end up affecting research, as well as overall preparedness strategies; as a result, ordinary administration is somehow (barely) guaranteed, but low-probability, highconsequence events such as covid- are often disregarded by public authorities. lombardy (a crown jewel of italy when it comes to healthcare) almost collapsed due to the lack of intensive care beds, leaving many patients unattended and many deaths occurring at home rather than in hospitals. summing up, both the global and eu governance of pandemics appear too fragmented and insufficiently coordinated. most countries are wildly unprepared, and the existing coordination mechanisms appear too weak to effectively prevent collective action problems, as well as fragmented and sparse reactions, to proliferate. in europe, the ecdc is likewise insufficiently endowed to effectively coordinate member states in providing a meaningful response. as in many global governance settings, the current situation can easily lead to collective action problems, as well as strategic behaviour. once the current emergency is over, and perhaps even before then, eu institutions will have to work in the direction of strengthening eu governance in various ways. first, there is a need to strengthen the resilience and sustainability of healthcare systems. health has been found to be a key concern for european citizens and an area for which the eu has been asked to expand its competences and powers. apart from generating important returns for society as a whole, investment in healthcare should be fostered as a way to increase both the resilience and the sustainability of member states' economies by enabling a transition towards measures that protect, prepare and transform the economy and society. resilience also entails cross-border effects and goes beyond pandemic preparedness, both within and outside the health domain. for example, the area of antimicrobial resistance has already been singled out by the united nations (un), the who, the eu and some national institutions as representing a massive global health and security risk. reducing vulnerability and increasing resilience are also essential in response to other threats, such as climate change and the protection of biodiversity. however, emphasis on resilience has been frustrated by a generalised quest for cost cutting and short-term economic efficiency in economic policy, which led to the elimination of all redundancy and excess capacity in critical infrastructures, including healthcare. increasing resilience will not be possible if worldwide, international institutions continue to emphasise unconditional fiscal discipline and financial markets continue to be tied to quarterly reports on public spending. this, too, will have to change. the same applies to the european semester: re-orientating it towards sustainable development, as the von der leyen commission seems willing to do, would require providing more visibility to existing health, social inclusion and sustainability indicators as well as adding new indicators and monitoring tools, including a careful planning of preparedness for health and other risks (see below). so far, despite the emphasis on a "triple a" for social policy in the juncker commission, the stability and growth pact has largely prioritised fiscal discipline over resilience-orientated investment. the european semester also potentially supports investment in health: however, so far it has clearly prioritised fiscal discipline over access to healthcare and promotion of health, putting further pressure on already strained healthcare systems. second, beyond resilience, more centralisation in healthcare governance is needed, especially to address health emergencies. the recent evaluation of the epis within the ecdc has highlighted important flaws, mostly on the side of member states. the voluntary nature of this multi-level cooperation resembles closely the lack of full coordination experienced in a neighbouring field, cybersecurity. moreover, the shortage of medical devices and medicines, an already existing problem in the eu, became more apparent and critical in the current emergency: problems in the supply of ventilators, protective masks and medicines have shown existing gaps and unveiled opportunities for europe to act more effectively. a strategic stockpile of medical devices (resceu) has now been set up to address the emergency: this, however, occurred only after member states attempted to implement export bans for critical medical equipment, ignoring any form of solidarity. a stronger role of the eu would have been advisable also with respect to the plethora of policy measures adopted at all levels of government to contain and delay the spread of the virus. social distancing, travel bans and other similar measures are thought to be ineffective or even dangerous unless enacted in a concerted and coordinated way. the eu has now issued ad hoc recommendations on testing strategies and community measures, but this took far too long, putting individuals and healthcare systems unnecessarily at risk. third, europe should ramp up its preparedness for a wider range of large-scale risks, beyond pandemics, and even beyond healthcare. it is important to avoid the repetition of a "panic-neglect-panic" cycle in the face of crisis. on the one hand, europe must avoid adopting a "disease-by-disease" strategy: as suggested by a un high-level panel that reviewed in the experience with the ebola outbreak, governments should avoid the temptation to emphasise "vertical" programmes focusing on specific diseases or toonarrow policy considerations (eg pandemic preparedness) and prioritise comprehensive, whole-of-government programmes aimed at strengthening all aspects of their national health systems. on the other hand, europe must also avoid a "threat-by-threat" siloed strategy: even if covid- was not human-made, the extent of the disruption it is creating will certainly entice bioterrorists, and it is clear that the rising role of digital technology in supplementing economic activities could make a combined attack (biological and digital) lethal for the world economy. the mounting awareness that most cyberattacks are hybrid (military and civilian) should spread towards analysing the likelihood of multi-vector attacks. against this background, even if it has already engaged in extensive risk mapping, europe does not have a dynamic, agile centre for the prevention of catastrophic risks. the use of high-performance computers, large datasets and advanced risk analysis techniques can support resilience in europe without requiring massive investment in new facilities and infrastructure for each sector. such a centre for the prevention of catastrophic risks could coordinate with existing non-executive agencies in specific sectors (eg the european network and information security agency (enisa), the ecdc, the european security and markets authority (esma) and the european banking authority (eba)) to alert policy-makers on outstanding threats and evolving risks, including multi-vector ones. with such a support network, the european commission could create an executive structure that would coordinate emergency responses by identifying the most effective sequence of measures and enable possible redistribution of materials and resources across member states to ensure the resilience of the whole union. finally, there are many ways to pursue enhanced resilience and responsiveness, but not all of them are compatible with sustainability and democratic values. the challenge is to find an adequate policy mix that safeguards individual rights and liberties, protects the economy and at the same time strengthens government preparedness for cases of epidemics and pandemics. building healthcare facilities at the national level based on the (current) needs during a pandemic outbreak makes little sense from a policy perspective; increasing capacity should rather be part of a more comprehensive preparedness strategy that includes the ability to react quickly and increase the number of beds, ventilators or other healthcare facilities in times of emergency. overstocking medicines at the national level is less efficient than doing so at the pan-european level. using technology to track the movement of citizens, as is done in china, is incompatible with individual liberties and fundamental rights and can give rise to widespread social discrimination over time. in the current emergency, the eu has a chance to show that risk management and governance is possible without sacrificing individual fundamental rights and jeopardising solidarity and the bloc's commitment to sustainable development. the president of the european commission, ursula von der leyen, is facing an uphill battle as member states repeatedly fail to resist the temptation of closing their borders and refusing to cooperate with their neighbours. the covid- emergency is thus becoming an existential challenge for the "geopolitical commission", and for the eu project as a whole. a cutting-edge approach to risk detection, analysis and management coupled with far-reaching economic stimuli, the responsible use of technology and the commitment to openly sharing research solutions can preserve the role of the eu as a guiding light in these troubled times. this is, of course, a non-exhaustive list of possible measures that would contribute to better governance and preparedness in the years to come. they are measures to be adopted in quieter times: as john f. kennedy once famously said, the time to fix the roof is when the sun is shining. it is essential that, once covid- gradually disappears, the lessons learned from these months of lockdown become the foundations of a new approach to risk governance at eu and global levels. the global preparedness monitoring board raised this same issue very clearly in its latest annual report: "for too long, we have allowed a cycle of panic and neglect when it comes to pandemics: we ramp up efforts when there is a serious threat, then quickly forget about them when the threat subsides". this time will hopefully be different: remembering what went wrong in times of crisis is essential to avoid repeating the same mistakes in the future. funding for public health in europe in decline?" ( ) health policy european commission, state of health in the eu the international health regulations years on: the governing framework for global health security anderson et al, supra, note public opinion in the european union return on investment of public health interventions: a systematic review building a scientific narrative towards a more resilient eu society, part : a conceptual framework eu country specific recommendations for health systems in the european semester process: trends, discourse and predictors the european semester from a health equity perspective strengthening the eu's cyber defence capabilities protecting humanity from future health crises report of the high-level panel on the global response to health crises overview of natural and man-made disaster risks the european union may face key: cord- -hfxal z authors: park, brian; steckler, niki; ey, sydney; wiser, amy l.; devoe, jennifer e. title: co-creating a thriving human-centered health system in the post-covid- era date: - - journal: nejm catal innov care deliv doi: . /cat. . sha: doc_id: cord_uid: hfxal z the clinical-burnout epidemic meets the covid- pandemic "tail": how health care leaders can respond. amongst u.s. health care professionals and students, with over half of health care workers and students reporting substantial symptoms of burnout , and up to one-third of medical trainees reporting clinical depression. lessons from prior epidemics -such as sars, mers, and h n -demonstrate that rates of stress, burnout, and post-traumatic stress amongst health care workers significantly increase not only during these episodes, but for over two years following widespread infectious outbreaks as well. , similarly, rates of productivity decreased, illustrating that attention to the well-being of our health professionals is not only a matter of workforce engagement, but also crucial for the health of our nation's population. we are entering a vulnerable period in which the psyche of the collective health workforce is especially susceptible to psychological distress and burnout, given the pre-pandemic baseline. we find reason for optimism, however, in the significant attention to workforce well-being during the pandemic by the national academy of medicine, medical associations, and health systems leaders. how can our collective focus on workforce well-being be sustained beyond the acute phase of the pandemic? how might we not just survive, but thrive? in the midst of this volatility and uncertainty, health care leaders will likely feel the burden of responsibility to implement solutions to maintain the well-being of the workforce. while these top-down solutions will be critical, they will need to be complemented with leadership that elicits and acts on insights from frontline health care workers. rather than reestablishing the old health system that led us to an epidemic of burnout, we need to engage all team members in rebuilding new, higher-functioning systems that promote workforce well-being. , health care professionals and leaders are already at-risk for psychological distress and burnout. health care is not immune to the societal economic recession, with financial impacts already resulting in widespread pay-cuts and layoffs. this reduced workforce coincides with the demands of restarting patient care, the threat of second waves of infection, and research activities that were deferred in order to enact physical distancing. in short, health care teams may be asked to provide even more care with even less time and resources than what existed prior to the pandemic. how will this be sustained? fortunately, history frames periods following pandemics as opportunities for positive systemic change. the global flu pandemic of ignited the development of european national health services, while the great depression and world war ii fortified the united states' welfare state. in a similar vein, organizational experts observe that leadership actions following crises tend to define organizational culture for decades, leading either to long-term stress injury and illness or to "posttraumatic stress growth." though no blueprint exists for leading organizations to well-being in the tail of a global pandemic, prior research in team leadership and organizational resilience points toward organizational factors that facilitate growth after crisis. , as we rebuild and reimagine our health care delivery organizations, we have the opportunity to implement practices associated with workforce engagement and satisfaction as well as improved financial performance. a successful tail strategy will require attention to enhanced structural, technical breakthroughs (e.g., sustaining telehealth, increased capacity for covid testing, value-based care delivery models). equally important, rebuilding thriving health care delivery organizations will require a newfound focus on relational, cultural leadership strategies (e.g., articulating a sense of purpose, cultivating psychological safety). workforce well-being and burnout prevention benefit from individual resilience practices, but are particularly influenced by organizational and leadership practices. leaders' words and actions can, albeit inadvertently, create a mindset of scarcity, where workforce attention is focused on survival and safety rather than thriving. initial covid- responses appropriately focused on providing essential needs such as personal protective equipment, food, temporary housing, and professional support for mental health. at the same time, agile task forces mobilized innovative and expert responses to emergent pandemic needs, including developing new covid- tests and supply chains and implementing telehealth and other creative methods for patient care. now, leaders have an unprecedented opportunity to prioritize organizational arrangements that support workforce well-being. we call on leaders at all levels to implement the following six evidence-informed leadership practices during the post-acute phase of pandemic response: humanize yourself, humanize others. the acute phase of the covid pandemic has changed our lives in unprecedented ways, leading to widespread human experiences of grief, anxiety, sadness, guilt, fatigue, and fear. the evidence on resonant leadership suggests that, in the face of uncertainty, effective leaders find the courage to be frequently available to their teams, and directly acknowledge their shared human vulnerability. interpersonally, during times of grieving at work, effective leaders create space for, and serve as witnesses to, team members' pain. and organizationally, effective leaders are transparent about sharing the known alongside the unknown, hopes alongside fears, and opportunities alongside realities. , physical distancing protocols will require leaders to creatively maintain presence and connection with team members. as the uncertainty lingers in the tail, visible, vulnerable, and humanistic leadership will be crucial to demonstrate to health care professionals that leaders are identifying with frontline experiences and emotions. we call on leaders to help team members reconnect with purpose by integrating meaningful projects into regular role expectations rather than relegating them to volunteer efforts outside of work or requiring a loss of productivity-based compensation." aim high, and encourage others to do the same. leaders have the opportunity to integrate well-being into our "new normal," optimizing the radical disruption to reimagine both our " workflows and our working relationships for greater human sustainability. effective leaders both soberly acknowledge the significant challenges that lie ahead and express cautious optimism about our ability to respond to the challenges. , we call on leaders to help team members reconnect with purpose by integrating meaningful projects into regular role expectations rather than relegating them to volunteer efforts outside of work or requiring a loss of productivity-based compensation. effective leaders also find ways to acknowledge and reinforce the positive actions of others (for example, including a "spreading good" feature in regular e-mail or team meetings as an accessible, shareable way to publicly acknowledge positive efforts in a relational forum). , effective leaders signal through their words and actions that people and relationships are prioritized amidst crises. care for yourself, and encourage a culture of self-care. the pandemic highlighted essential needs of health care professionals (regular breaks, food during long shifts, respite spaces) and reminded us that well-intended gestures to foster self-care might be insufficient or impractical in certain frontline settings. identifying practical opportunities for self-care requires engagement of front-line team members, given the potential for well-intended initiatives to lack practicality and foster discouragement, or even cynicism (e.g., giving team members a water bottle to encourage hydration without providing time for bathroom breaks). leaders have the opportunity not only to verbally encourage self-care, but to model it themselves, prioritizing integrated time and space for these practices, including seeking professional support if needed. inviting team members to share something personal, such as an uplift or joy, leads to greater engagement, creative problem solving and a sense of connection. now, more than ever, health care professionals and staff benefit from opportunities to share positive and meaningful experiences. flatten hierarchies and spur innovation. as health care organizations emerge from centralized, hierarchical "emergency response" structures, a shift in leadership practices will be required in order to innovate into the new normal, integrating perspectives of all team members. grassroots innovation requires that front-line team members be empowered with authority and resources to respond quickly without layers of approval. leaders create a sense of being valued and empowered when they find ways to say "yes," acknowledge not having all the answers, invite and value all voices, express appreciation for divergent views, and make conversational equity the norm. these hierarchy-flattening leadership behaviors increase the odds that team members feel psychologically safe to take interpersonal risks, such as sharing new ideas, challenging groupthink, or admitting mistakes, all of which foster creative thinking. , cultivating psychological safety for both emotional well-being and to spur innovation will increase engagement from frontline team members to redesign and realign workflows. leaders may further consider redesigning compensation practices to include improvement as part of team members' core paid work. we risk hastily reintegrating team members into their typical responsibilities, at the expense of allowing time for them to reflect on their pandemic experiences and look for meaning and healing." " prioritize time for individual and collective recovery and reflection. as rates of covid- infections fall and non-urgent health services resume, we risk hastily reintegrating team members into their typical responsibilities, at the expense of allowing time for them to reflect on their pandemic experiences and look for meaning and healing. many team members will have experienced the illness or loss of a beloved colleague or family member, moral conflict, or ongoing distress around pervasive changes to work and life. no single psychological support resource will address all individuals' needs. rather, leaders are encouraged to advocate for accessible support resources, including psychological first aid, ongoing professional counseling, formal peer support, and reflective group activities (e.g., narrative medicine or "schwartz rounds" that focus on the emotional impact of patient care on the provider). mandatory single-session group debriefings about traumatic experiences are not a recommended practice for addressing trauma and may actually cause more distress among some attendees. in addition to providing individual-level opportunities for learning from the crisis, leaders can also encourage ongoing collective reflection by inviting team members to check in emotionally with their colleagues, reflect on their experiences, and distill learnings. appreciative inquiry practices can yield important lessons about how to strengthen our response to stressors in the future. these reflective practices could become imprinted into a longer-term culture of enhanced organizational resilience. invest in relationship-based forms of leadership development. an increasing body of evidence documents the mutually reinforcing impact of combining investments in relational capacity alongside investments in technical systems (e.g., quality and process improvement methodologies). enhanced relationship skills are crucial for leaders at all levels, given evidence that middle managers account for at least % of the variance in employee satisfaction and engagement at work, and that emotional intelligence, humility, and a strengths-based approach to leadership are associated not only with workforce satisfaction, but with improved quality of care. senior leaders can play a critical role in fostering workforce well-being during the tail by supporting leadership development opportunities for mid-level leaders in the organization who directly influence the experience of the front-line workforce. leaders may also appreciate being able to receive confidential coaching on ways to promote these relational practices and to learn from other leaders through facilitated group discussions on team and organizational resilience. the covid- tail offers an unprecedented opportunity to enhance health care organizations' human and financial sustainability. our aligned purpose during covid- 's acute response phase can be extended to support long-term workforce well-being by creating new workflows and cultures that integrate both relational and technical best practices. without team and cultural practices that explicitly invite and value all voices, we risk losing crucial and timely front-line data and perspectives. work units that have previously invested in team culture can lead the way and serve as models. implementing these recommendations will require vision and perseverance on the part of leaders at all levels, as well as clarity and discipline regarding which decisions need to be made centrally and which can be entrusted to front line team members who are doing the work. during this period of physical distancing and forced over-use of technology for communication, it is both additionally challenging -and all the more crucial -for leaders to find ways to connect with, recognize, and humanize individuals throughout the organization. taking action against clinician burnout: a systems approach to professional well-being depression in medical students: current insights long-term psychological and occupational effects of providing hospital healthcare during sars outbreak factors influencing emergency nurses' burnout during an outbreak of middle east respiratory syndrome coronavirus in korea resources to support the health and well-being of clinicians during covid- caring for our caregivers during covid- supporting clinicians during the covid- pandemic from triple to quadruple aim: care of the patient requires care of the provider the quadruple aim: care, health, cost and meaning in work executive leadership and physician well-being: nine organizational strategies to promote engagement and reduce burnout we can't go back to normal': how will coronavirus change the world? the guardian caring for health workers during crisis: creating a resilient organization responding to covid- : lessons from management research factors associated with mental health outcomes among health care workers exposed to coronavirus disease the psychology behind effective crisis leadership resonant leadership: renewing yourself and connecting with others through mindfulness, hope, and compassion the russell sage foundation series on trust teaming to innovate speeding up team learning a critical examination of the role of appreciative inquiry within an interprofessional education initiative teamstepps for health care risk managers: improving teamwork and communication beyond burnout: a physician wellness hierarchy designed to prioritize interventions at the systems level the role of positive emotions in positive psychology. the broaden-and-build theory of positive emotions transforming teamwork: cultivating collaborative cultures psychological safety and learning behavior in work teams the mark of the millennial: reshaping healthcare education and delivery suicides of two health care workers hint at the covid- mental health crisis to come feasibility of a comprehensive wellness and suicide prevention program: a decade of caring for physicians in training and practice covid- : peer support and crisis communication strategies to promote institutional resilience world health organization. psychological debriefing in people exposed to a recent traumatic event a mixed methods study of change processes enabling effective transition to team-based care state of the american manager: analytics and advice for leaders relationships and resilience: care provider responses to pressures from managed care impact of relational coordination on quality of care, postoperative pain and functioning, and length of stay: a nine-hospital study of surgical patients key: cord- -yfuuirnw authors: severin, paul n.; jacobson, phillip a. title: types of disasters date: - - journal: nursing management of pediatric disaster doi: . / - - - - _ sha: doc_id: cord_uid: yfuuirnw disasters are increasing around the world. children are greatly impacted by both natural disasters (forces of nature) and man-made (intentional, accidental) disasters. their unique anatomical, physiological, behavioral, developmental, and psychological vulnerabilities must be considered when planning and preparing for disasters. the nurse or health care provider (hcp) must be able to rapidly identify acutely ill children during a disaster. whether it is during a natural or man-made event, the nurse or hcp must intervene effectively to improve survival and outcomes. it is extremely vital to understand the medical management of these children during disasters, especially the use of appropriate medical countermeasures such as medications, antidotes, supplies, and equipment. skeleton as a result of incomplete calcification and active bone growth centers. protected organs, such as the lungs and heart, may be injured due to overlying fractures. cervical spine injuries can also be pronounced, as in patients with head trauma. in fact, spinal cord injury may be present without any radiographic abnormalities of the spine. finally, vital signs will vary based on the pediatric patient's age. this may be a pitfall during rapid evaluation by any nurse or hcp not accustomed to the care of children. younger pediatric patients have higher metabolic rates and, therefore, higher respiratory rates and heart rates. this can be a distinct disadvantage versus older pediatric patients when encountering similar diseases. an example is inhaled toxins (e.g., nerve agents and lung-damaging agents). infants and children will suffer greater toxicity since they inhale at a faster rate due to higher metabolic demands and thus, distribute the toxin more rapidly to various end-organs. understanding respiratory differences is essential to the management of the acutely ill pediatric patient. the most common etiology for cardiorespiratory arrest in children is respiratory pathology, typically of the upper airway. most of the airway resistance in children occurs in the upper airway. nasal obstruction can lead to severe respiratory distress due to infants being obligate nose breathers. their relatively large tongue and small mouth can lead to airway obstruction quickly, especially when the neuromuscular tone is abnormal such as during sedation or encephalopathy. in infants, physiologic (i.e., copious secretions) and pathologic (i.e., edema, vomitus, blood, and foreign body) factors will exaggerate this obstruction. securing the airway in such events can be quite challenging. typically, the glottis is located more anterior and cephalad. appropriate visualization during laryngoscopy can be further hampered by the prominent occiput that causes neck flexion and, therefore, reduces the alignment of visual axes. the omega or horseshoeshaped epiglottis in young infants and children is quite susceptible to inflammation and swelling. as in epiglottitis, the glottis becomes strangulated in a circumferential manner leading to dangerous supraglottic obstruction. children also have a natural tendency to laryngospasm and bronchospasm. finally, due to weaker cartilage in infants, dynamic airway collapse can occur especially in states of increased resistance and high expiratory flow. along with altered pulmonary compensation and compliance, a child may rapidly progress to respiratory failure and possibly arrest. cardiovascular differences are critical in the pediatric patient. typical physiological responses tend to allow compensation with seemingly normal homeostasis. with tachycardia and elevated systemic vascular resistance, younger pediatric patients can maintain normal blood pressure despite decreased cardiac output and poor perfusion (compensated shock). since children have less blood and volume reserve, they progress to this state quickly. in pediatric patients with multiorgan injury or severe gastrointestinal losses, these compensatory mechanisms are pushed to their limits. the unaccustomed hcp may be lulled into complacency since the blood pressure is normal. all the while, the pediatric patient's organs are being poorly perfused. once these compensatory mechanisms are exhausted, the patient rapidly progresses to hypotension and, therefore, hypotensive shock. if not reversed expeditiously, this may lead to irreversible shock, ischemia, multiorgan dysfunction, and death. pediatric patients with altered mental status pose significant problems. the differential diagnosis will be very broad in the comatose patient based on development alone. for example, younger pediatric patients can present with nonconvulsive status epilepticus (ncse) instead of generalized convulsive status epilepticus (gcse). in fact, ncse is more common among younger pediatric patients than gcse, especially in those from to months of age. furthermore, many of them are previously well without preexisting diseases such as epilepsy. other disease states may include poisoning, inborn errors of metabolism, meningitis, and other etiologies of encephalopathy. using the modified pediatric glasgow coma scale (gcs) is the cornerstone when evaluating the young pediatric patient when they are preverbal. pupillary response, external ocular movements, and gross motor response may be challenging to evaluate in a developmentally young or delayed pediatric patient. pediatric traumatic brain injury is extremely devastating. whether considered accidental (motor vehicle crash) or nonaccidental (abusive head trauma), evaluation of the neurological status of the acutely injured pediatric patient can be problematic, especially the gcs. some prefer to use the avpu system (alert, responds to verbal, responds to pain, and unresponsive). due to the disproportionately larger head and weaker neck muscles, there is more risk of acceleration-deceleration injuries (fall from a significant height, vehicular ejection, and abusive head trauma). furthermore, the softer skull, dural structural differences, and vessel supply will place the pediatric patient at risk for brain injury and intracranial hemorrhage. finally, due to pediatric brain composition, the risk of diffuse axonal injury and cerebral edema is much higher. although spinal cord injury is rare in young pediatric patients, morbidity and mortality are significant. in pediatric patients less than years of age, the most commonly seen injuries are in the atlas, axis, and upper cervical vertebrae. in young pediatric patients, spinal injuries tend to be anatomically higher (cervical) versus adolescents (thoracolumbar). furthermore, congenital abnormalities, such as atlantoaxial abnormalities (trisomy ), may exaggerate the process. the clinical presentation of spinal cord injury varies in young pediatric patients due to ongoing development. laxity of ligaments, wedge-shaped vertebrae, and incomplete ossification centers contribute to specific patterns of injuries. finally, spinal cord injury without radiographic abnormality (sciwora) may result. because of the disproportionately larger head, weaker neck muscles, and elasticity of the spine, significant distraction and flexion injury of the spinal cord may occur without apparent ligament or bony disruption (hilmas et al. ; jacobson and severin ; severin ). motor skills develop from birth. gross and fine motor milestones are achieved in a predictable manner and must be assessed during each hcp encounter. cognitive development will follow a similar pattern of maturation. the development of these skills can often predict injuries and their extent. for example, consider a house fire. a young infant, preschooler, and adolescent are sleeping upstairs in house when a fire breaks out in the middle of the night. the smoke detectors begin to alarm. each child is awoken by the ensuing noise and chaos. based on the development, the adolescent will most likely make it out of the house alive. he will comprehend the threat, run down the stairs, and exit the house without delay. smoke inhalation may be minimal. if it is a middle adolescent, an attempt may be made to jump out of the window leading to multiple blunt trauma with or without traumatic brain injury. the preschooler most likely will be too scared and not understand how to escape. tragically, he may hide under a bed or in a closet. when the firefighters arrive and search the house, the preschooler may remain silent because of fear, especially of strangers in the house. he will most likely succumb to thermal injuries along with the effects of carbon monoxide and die. as far as the infant, he cannot walk, climb, crawl, or run. furthermore, he cannot scream for help or know how to escape. as the smoke engulfs the room, he will most likely suffer severe smoke inhalation injury including extensive carbon monoxide toxicity along with thermal injuries and die. this example also points out another important difference in pediatric patients: their dependence on caregivers. when considering neonates, for example, their entire existence depends on the caregiver, including feeding, changing of diapers, nurturing, and environmental safety. these dynamics are essential to the pediatric patient's health and survival, especially during a disaster. another aspect of development is the attainment of language skills. this, too, develops over time in a predictable fashion. one of the biggest challenges in pediatrics is the lack of the patient's ability to verbally convey complaints. as described above, verbal milestones vary among the different age ranges of the pediatric patient. hcps are often faced with a caregiver's subjective assessment of the problem. although it can be revealing and informative, this may not be available in an acute crisis situation. it will take the astute hcp to determine, for example, if an inconsolably crying infant is in pain from a corneal abrasion or something more life-threatening such as meningitis. this can also be a challenging task in a teenager, especially during middle adolescence. an hcp will have to determine, for example, if the seemingly lethargic middle adolescent is intoxicated with illicit drugs or has diabetic ketoacidosis. finally, the hcp will have to address developmental variances among their pediatric patients and any comorbid features. young pediatric patients can regress developmentally during any illness or injury. this is especially seen in patients with chronic medical conditions (cancer) or during prolonged hospitalization with rehabilitation (multisystem trauma). furthermore, those pediatric patients with developmental and intellectual disabilities, for example, will be difficult to evaluate based on the effects of their underlying pathology. these pediatric patients typically have unique variances in their physical exams (jacobson and severin ; severin ) . please refer to chap. for more detailed information on pediatric development. pediatric patients will often reflect the emotional state of their caregiver. they take verbal and physical cues from their caregiver. at times, this may also occur in the presence of a nurse or hcp. the psychological impact of illness will vary greatly with the child's development and experience. children tend to have a greater vulnerability to post-traumatic stress disorder especially with disaster events. furthermore, they are highly prone to becoming psychiatric casualties despite the absence of physical injury to themselves. and as any pediatric hcp can tell you, the younger pediatric patients tend to also have greater levels of anxiety, especially while preparing for invasive procedures such as phlebotomy and intravenous line placement (hilmas et al. ; jacobson and severin ; severin ) . please refer to chap. for more detailed content on mental health. the world health organization and the pan american health organization define a disaster as "an event that occurs in most cases suddenly and unexpectedly, causing severe disturbances to people or objects affected by it, resulting in the loss of life and harm to the health of the population, the destruction or loss of community property, and/or severe damage to the environment. such a situation leads to disruption in the normal pattern of life, resulting in misfortune, helplessness, and suffering, with adverse effects on the socioeconomic structure of a region or a country and/or modifications of the environment to such an extent that there is a need for assistance and immediate outside intervention" (lynch and berman ). types of disasters usually fall into two broad categories: natural and man-made. natural disasters are generally associated with weather and geological events, including extremes of temperature, floods, hurricanes, earthquakes, tsunamis, volcanic eruptions, landslides, and drought. naturally occurring epidemics, such as the h n , ebola, and novel coronavirus outbreaks, are often included in this category. man-made disasters are usually associated with a criminal attack such as an active shooter incident, or a terrorist attack using weapons such as explosive, biological, or chemical agents. however, man-made disasters can also refer to human-based technological incidents, such as a building or bridge collapse, or events related to the manufacture, transportation, storage, and use of hazardous materials, such as the chernobyl radiation leak and the bhopal toxic gas leak. even though disasters can be primarily placed into any of these two categories, they can often impact each other and compound the magnitude of any disaster incident (united states department of homeland security, office of inspector general ). a prime example is the march tohoku earthquake leading to a tsunami (natural) that triggered the fukushima daiichi nuclear disaster (man-made). disasters can also be characterized by the location of such an event. internal disasters are those incidents that occur within the health care facility or system. employees, physical plant, workflow and operations of the clinic, hospital, or system can be disrupted. external disasters are those incidents that occur outside of the health care facility or system. this impacts the community surrounding the facility, proximally or distally, but does not directly threaten the facility or its employees. as with natural and man-made disasters, internal and external disasters can impact each other. for example, an overflow of patients during a high census period may lead to the shutdown of the hospital to any new patients (internal disaster). this will place the hospital on bypass and possibly stress other hospitals in the community beyond their means (external disaster). a terrorist event, such as the release of sarin in a subway system during a busy morning commute, can lead to massive disruption in the community (external disaster). all the victims of the attack will seek medical care at nearby hospitals, possibly overwhelming the health care staff and depleting critical resources (internal disaster). characterization of disasters by geography (local, state, national, and international) can also be used. again, no matter the site of the incident, a disaster in one area could easily create a disaster in another geographical region. for example, a factory and its community could be ravaged by a hurricane (local disaster). if this is the only factory in the world to produce a certain medication, this could lead to critical shortages to hospitals all around the world (international disaster). the term "disaster preparedness" has been used over the years as a way to describe efforts to manage any disaster event. however, preparedness is only one aspect of the process. the use of the term disaster planning is more appropriate. it considers all aspects needed for an effective effort and is dependent on additional phases, not just preparedness. national preparedness efforts, including planning, are now informed by the presidential policy directive (ppd) that was signed by the president in march and describes the nation's approach to preparedness (united states department of education, office of elementary and secondary education, office of safe and healthy students ; united states department of homeland security b). a recommended method for disaster preparedness efforts is the utilization of an "all-hazards" model of emergency management (adini et al. ; waugh ) . the four overlapping phases of the model include mitigation, preparedness, response, and recovery. the mitigation phase involves "activities designed to prevent or reduce losses from a disaster" (waugh ) . examples include land use planning in flood plains, structural integrity measures in earthquake zones, and deployment of security cameras. the preparedness phase includes the "planning of how to respond in an emergency or a disaster, and developing capabilities for more effective response" (waugh ) . examples include training programs for emergency responders, drills and exercises, early warning systems, contingency planning, and development of equipment and supply caches. up to this point, all planning efforts are proactive and not reactive. often times, a hazard analysis is conducted to delineate areas of strengths and identify potential risks. it helps in "the identification of hazards, assessment of the probability of a disaster, and the probable intensity and location; assessment of its potential impact on a community; the property, persons, and geographic areas that may be at risk; and the determination of agency priorities based on the probability level of a disaster and the potential losses" (waugh ) . after a disaster or emergency incident occurs, the response phase, or "immediate reaction to a disaster", (waugh ) begins. examples include mass evacuations, sandbagging buildings and other structures, providing emergency medical services, firefighting, and restoration of public order. in some situations, the response period may be a short (e.g., house fire), intermediate (e.g., bomb detonation), or extended (e.g., pandemic influenza) duration. after a period of time, the recovery phase follows. these are "activities that continue beyond the emergency period to restore lifelines" (waugh ) . examples include the provision of temporary shelter, restoration of utilities such as power, critical stress debriefing for responders, and victims, job assistance and small business loans, and debris clearance. recovery always seems to be the most unpredictable; it may take days to months to years. as demonstrated with recent hurricanes harvey, irma, and maria in , the most affected regions are still in the phase of recovery and may be along a prolonged track as hurricane katrina in . as mentioned, the early phases of planning (mitigation and preparedness) truly hinge upon the environment or community surrounding the health care site (e.g., clinic, hospital, or long-term care facility). identification of potential hazards and risks is a key step in disaster planning. using a hazard vulnerability assessment (hva) or a threat and hazard identification and risk assessment (thira) can provide a basis for mitigation and prevention tasks. an hva/thira emphasizes which types of natural or man-made disasters are likely to occur in a community (e.g., tornado, flood, chemical release, or terrorist event). they further highlight the impact those disasters may have on the community and any capabilities that are in place that may lessen the effects of the disaster (illinois emergency medical services for children ). a basic principle of the hva methodology is to determine the risk of such an event or attack occurring at a given hospital or hospital system. simply, the risk is a product of the probability of an event and the severity of such an event if it occurs (risk = probability × severity). however, there are many complexities in quantifying terrorism risk (waugh ; woo ) . it is important to note that in some circumstances, exposure may need to be included in the equation (risk = probability × severity × exposure), but usually for operational risk management applications (mitchell and decker ) . at any rate, issues to consider for the probability of an event occurring include, but are not limited to, geographic location and topography, proximity to hazards, degree of accessibility, known risks, historical data, and statistics of various manufacturer/vendor products. severity, on the other hand, is dependent on the gap between the magnitude of an event and mitigation for the given event (severity = magnitude -mitigation). magnitude varies upon the impact of the event to humans, property, and/or business. mitigation varies upon the development of internal and external readiness before a disaster strikes. as one can surmise, if the magnitude of the event outstrips the mitigation, the event is considered a threatening hazard. once the hva is completed, the health care site should immediately prioritize planning efforts for the top - hazards and develop plans accordingly. all other identified hazards must also be addressed to ensure a broad and robust disaster plan. it is important to realize that local and regional entities also perform comprehensive hvas. a concerted analysis among a hospital and key community stakeholders is optimal for a coordinated plan. an hva/thira contains both quantitative and qualitative components. specific tools have been developed through private and public organizations (e.g, fema) that can help in the analysis (united states department of homeland security, federal emergency management agency ). using these tools as a guide, the entity can determine what types of hazards have a high, medium, or low probability of occurring within specific geographic boundaries. typically, these tools do not have components specific to children or other at-risk populations. however, the tools can be adapted either directly by adding children to specific hazards or ensuring considerations specific to children are incorporated into the hva/thira calculations. the hva/thira should be reviewed and updated minimally on an annual basis to identify changing or external circumstances. this includes conducting a pediatric-specific disaster risk assessment to identify where children congregate and their risks (e.g., schools, popular field trip designations, summer camps, houses of worship, and juvenile justice facilities) (illinois emergency medical services for children ). of note, hva techniques have been utilized for pediatric-specific disaster plans. having a separate pediatric hva (phva) is crucial to a well-rounded and robust health care disaster plan. first, it demonstrates the extent of the pediatric population in the community. it is estimated that % of the population fits within the age range of pediatric patients. in some situations, it may be more. during the performance of a phva, it was demonstrated that % of the community was less than years of age (jacobson and severin ) . second, a phva increases the situational awareness of those tasked to plan for disasters that involve children and adolescents. often times, children and adolescents are excluded from local and regional disaster plans. the unique vulnerabilities of pediatric patients will demand appropriate drills, exercises, equipment, medications, and expertise. thirdly, identifying pediatric risks in a community will help prioritize efforts of planning, especially in those hospitals not accustomed to caring for pediatric patients. finally, a phva helps to develop a framework for global pediatric disaster planning. this can extend beyond a local community and actually advance city, state, regional, and national disaster planning efforts. there has been a development of web-based tools to simplify and enhance the phva process (jacobson and severin ) . after an hva/thira has been completed, the results should be used to help direct and plan drills/exercises based on high impact and high probability threats. it is advised to conduct an hva/thira on an annual basis to assess specific threats unique to your organization's physical structure as well as the surrounding geographic environment. it will also provide insight into whether there is an improvement in previous planning efforts. completion of a population assessment that provides a demographic overview of the community with a breakdown of the childhood population is strongly recommended in conjunction with the hva/ thira. collaborating with other community partners, such as local health departments and emergency management agencies, can assist an organization with the conduction of a comprehensive hva/thira (illinois emergency medical services for children ). please see chap. for further information on hospital planning. pediatric supplies, equipment, and medications will be scarce during a disaster. it will become more of an issue if the health care facility is not accustomed to caring for acutely ill pediatric patients. this will be further exacerbated by a massive surge of acutely ill pediatric patients, a widespread or prolonged disaster, and supply line disruptions. to protect the health security of children and families during a public health emergency, the assistant secretary for preparedness and response (aspr) manages and maintains the strategic national stockpile (sns), a cache of medical countermeasures for rapid deployment and use in response to a public health emergency or disaster (fagbuyi et al. ) . various pediatric-specific supplies and countermeasures are included in the sns. maintaining a supply of medications and medical supplies for specific health threats allows the stockpile to respond with the right product when a specific disease or agent is known. if a community experiences a large-scale public health incident in which the disease or agent is unknown, the first line of support from the stockpile is to send a broad-range of pharmaceuticals and medical supplies. place and martin ) . the emergency equipment and supply lists can easily be adapted for any pediatric disaster emergency (place and martin ) or incident requiring pediatric mass critical care (desmond et al. ) . ageappropriate nutrition, hygiene, bedding, and toys/distraction devices should also be available (illinois emergency medical services for children ) (tables . and . ). endotracheal tubes • uncuffed: . and . mm • cuffed or uncuffed: . , . , . , . , and . mm • cuffed: . , . , . , . , and . mm feeding tubes ( f and f) laryngoscope blades curved: and ; straight: , , , and laryngoscope handle magill forceps (pediatric and adult) nasopharyngeal airways (infant, child, and adult) oropharyngeal airways (sizes - ) stylets for endotracheal tubes (pediatric and adult) suction catheters (infant, child, and adult) tracheostomy tubes (sizes . , . , . , . , . , . , and . mm) yankauer suction tip bag-mask device (manual resuscitator), self-inflating (infant size: ml; adult size: ml) clear oxygen masks (standard and nonrebreathing) for an infant, child, and adult masks to fit bag-mask device adaptor (neonatal, infant, child, and adult sizes) nasal cannulas (infant, child, and adult) nasogastric tubes (sump tubes): infant ( f), child ( f), and adult ( f- f) laryngeal mask airway a vascular access arm boards (infant, child, and adult sizes) catheter over-the-needle device ( - gauge) intraosseous needles or device (pediatric and adult sizes) intravenous catheter-administration sets with calibrated chambers and extension tubing and/or infusion devices with ability to regulate rate and volume of infusate umbilical vein catheters ( . f and . f) b central venous catheters ( . f- . f) intravenous solutions to include normal saline, dextrose % in normal saline, and dextrose % in water fracturemanagement devices extremity splints, including femur splints (pediatric and adult sizes) spine-stabilization method/devices appropriate for children of all ages c (continued) laryngeal mask airways could be shared with anesthesia but must be immediately accessible to the ed b feeding tubes (size f) may be used as umbilical venous catheters but are not ideal. a method for securing the umbilical catheter, such as an umbilical tie, should also be available c a spinal stabilization device is one that can stabilize the neck of an infant, child, or adolescent in a neutral position when a pediatric disaster victim presents acutely ill to the hospital, various emergency interventions will be needed to stabilize the patient. evaluation of the pediatric patient should include a primary survey (abcde), secondary survey (focused sample history and focused physical examination), and diagnostic assessments (laboratory, radiological, and other advanced tests). this will guide further therapeutic interventions. particular attention should be given to the identification of respiratory and/or circulatory derangements of the child, including airway obstruction, respiratory failure, shock, and cardiopulmonary failure. interventions will be based on physiologic derangements of the pediatric patient and determined by the scope of practice and protocols, such as standard resuscitation algorithms for neonatal (american academy of pediatrics and american heart association et al. ) and pediatric (american heart association ) victims. the hcp must be knowledgeable of various emergency medications (table . ) used for children, the appropriate dosages and their mechanism of action, any potential side effects, and drug/drug interactions. other medications, such as antibiotics, antidotes, or countermeasures, may be needed as well. pharmacologic therapy should be initiated immediately based on clinical suspicion and not delayed due to pending laboratory tests (e.g., antibiotics for presumed infection/sepsis or antidotes for suspected nerve agents). dosages should be based on the patient's weight or a length-based weight system. (montello et al. ) or hard copy countermeasure manuals may be more practical, especially during a disaster incident when computer service or internet access may be unreliable. in , the centre for research on the epidemiology of disasters (cred) launched the emergency events database (em-dat). em-dat was created with the initial support of the world health organization (who) and the belgian government. the main objective of the database is to serve the purposes of humanitarian action at national and international levels. the initiative aims to rationalize decision-making for disaster preparedness as well as provide an objective base for vulnerability assessment and priority setting. em-dat contains essential core data on the occurrence and effects of over , mass disasters in the world from to the present day. the database is compiled from various sources, including united nation agencies, nongovernmental organizations (ngos), insurance companies, research institutes, and press agencies (cred ). as described in the cred report entitled natural disasters : lower mortality, higher cost, a disaster is entered into the database if at least one of the following criteria is fulfilled: or more people reported killed; or more people reported affected; declaration of a state of emergency; and/or call for international assistance (cred ). in economic losses, poverty and disasters - : cred/unisdr report, the cred defines a disaster as "a situation or event which overwhelms local capacity, necessitating a request at national or international level for external assistance; an unforeseen and often sudden event that causes great damage, destruction and human suffering" (cred ). the cred em-dat classifies disasters according to the type of hazard that triggers them. the two main disaster groups are natural and technological disasters. there are six natural disaster subgroups. geophysical disasters originate from the solid earth and include earthquake (ground movement and tsunami), dry mass movement (rock fall and landslides), and volcanic activity (ash fall, lahar, pyroclastic flow, and lava flow). lahar is a hot or cold mixture of earthen material flowing on the slope of a volcano either during or between volcanic eruptions. meteorological disasters are caused by short-lived, micro-to meso-scale extreme weather and atmospheric conditions that last from minutes to days and include extreme temperatures (cold wave, heat wave, and severe winter conditions such as snow/ice or frost/ freeze), fog, and storms. storms can be extra-tropical, tropical, or convective. convective storms include derecho, hail, lightning/thunderstorm, rain, tornado, sand/dust storm, winter storm/blizzard, storm/surge, and wind. derecho is a widespread and usually fast-moving windstorm associated with convection/convective storm and includes downburst and straight-line winds. hydrological disasters are caused by the occurrence, movement, and distribution of surface/subsurface freshwater and saltwater and include floods, landslides (an avalanche of snow, debris, mudflow, and rockfall), and wave action (rogue wave and seiche). flood types can be coastal, riverine, flash, or ice jam. climatological disasters are caused by longlived, meso-to macro-scale atmospheric processes ranging from intraseasonal to multidecadal climate variability and include drought, glacial lake outburst, and wildfire (forest fire, land fire: brush, bush, or pasture). biological disasters are caused by the exposure to living organisms and their toxic substances or vectorborne diseases that they may carry and include epidemics (viral, bacterial, parasitic, fungal, and prion), insect infestation (grasshopper and locust), and animal accidents. extraterrestrial disasters are caused by asteroids, meteoroids, and comets as they pass near-earth, enter earth's atmosphere, and/or strike the earth, and by changes in the interplanetary conditions that affect the earth's magnetosphere, ionosphere, and thermosphere. types include impact (airbursts) and space weather (energetic particles, geomagnetic storm, and shockwave) events (cred ). there are three technological disaster subgroups. industrial accidents include chemical spills, collapse, explosion, fire, gas leak, poisoning, radiation, and oil spills. a chemical spill is an accidental release occurring during the production, transportation, or handling of hazardous chemical substances. transport accidents include disasters in the air (airplanes, helicopters, airships, and balloons), on the road (moving vehicles on roads or tracks), on the rail system (train), and on the water (sailing boats, ferries, cruise ships, and other boats). miscellaneous accidents vary from collapse to explosions to fires. collapse is an accident involving the collapse of a building or structure and can either involve industrial structures or domestic/nonindustrial structures (cred ). technological disasters are considered man-made, but as suggested by their subgroup, they are accidental and not intentional. the united nations office for disaster risk reduction (unisdr) and cred report, economic losses, poverty, and disasters - , reviews global natural disasters during that time period, their economic impact, and the relationship with poverty. between and , climate-related and geophysical disasters killed . million people and left a further . billion injured, homeless, displaced, or in need of emergency assistance. although the majority of fatalities were due to geophysical events, mostly earthquakes and tsunamis, % of all disasters was caused by floods, storms, droughts, heatwaves, and other extreme weather events. the financial impact was staggering. in - , disaster-hit countries reported direct economic losses valued at us$ billion, of which climate-related disasters caused us$ billion or % of the total. this was up from % (us$ billion) of losses (us$ billion) reported between and . overall, reported losses from extreme weather events rose by % between these two -year periods. in absolute monetary terms, over the last -years, the usa recorded the biggest losses (us$ billion), reflecting high asset values as well as frequent events. china, by comparison, suffered a significantly higher number of disasters than the usa ( vs. ) but lower total losses (us$ billion) (cred ) (figs. . , . , . , . , . , . , . , . and . in , climate-related and geophysical incidents in the world were estimated with , deaths and over million people impacted. indonesia recorded approximately half of the deaths with india accounting for half of those impacted by disasters. notable features of were intense seismic activity in indonesia, a series of disasters in japan, floods in india, and an eventful year for both volcanic activity and wildfires. however, an ongoing trend of lower death tolls from previous years continued into (centre for research on the epidemiology of disasters (cred) and united nations office for disaster risk reduction (unisdr) ) (tables . , . , . , . , . , . and . there are no specific deviations when medically managing children after a natural disaster. according to sirbaugh and dirocco ( ) "small-scale mass casualty incidents occur daily in the united states. few present unusual challenges to the local medical systems other than in the number of patients that must be treated at one time. except in earthquakes, explosions, building collapses, and some types of terrorist attacks, the same holds true for large-scale disasters. sudden violent disaster mechanisms can produce major trauma cases, including patients needing field amputations or management of crush syndrome. for the most part, medicine after a disaster is much the same as it was before the disaster, with more minor injuries, more people with exacerbations of their chronic illnesses, and number of patients seeking what is ordinarily considered primary care. this is true for children and adults." it should be noted, however, that children have a predisposition to illness and injury after natural disasters. the hcp must be able to identify any health problems and treat the child effectively and efficiently while utilizing standard resuscitation protocols as indicated. traumatic injuries may be seen after any natural disaster. the injuries can range from minor scrapes and bruises to major blunt trauma or traumatic brain injury. children are at increased risk for injury since adults are distracted by recovery efforts and may not be able to supervise them closely. the environment may not be safe due to environmental hazards, such as collapsed buildings, sinkholes, and high water levels. dangerous equipment used during relief efforts may be present, such as heavy earth moving equipment, chainsaws, and power generators. hazardous chemicals, such as gasoline and other volatile hydrocarbons, may be readily accessible or taint the environment. without suitable shelter, children are also exposed to weather, animals, and insects (sirbaugh and dirocco ) . infectious diseases may also pose a problem to children after a natural disaster. infectious patterns will persist during a disaster based on the season and time of year. there may be outbreaks or epidemics of highly contagious infections (e.g., influenza, respiratory syncytial virus, streptococcus pyogenes) due to mass sheltering of children and families. poor nutrition or decreased availability of food may lower their resistance against infections. various water-borne or food-borne diseases may cause illnesses in children. poor hygiene and mass shelter environments may exacerbate these illnesses. immunized children should be protected against common preventable diseases after a natural disaster but still could be a problem in mass groups that are not completely or appropriately immunized. after the haiti earthquake, there were increased cases of diarrhea, cholera, measles, and tetanus in children months after the earthquake despite some level of vaccination (sirbaugh and dirocco ) . children are at risk for various environmental emergencies. austere environments will impact children greatly. heat exposure coupled with minimal access to drinkable water may lead to severe dehydration. exposure to the cold may lead to frostbite or hypothermia. children are at risk for carbon monoxide toxicity due to generator use or natural gas poisoning due to disrupted gas lines. there is always a risk for thermal injury due to the use of candles and other flame sources. exposure to animals (snakes) and insects (spiders) may increase the risk of envenomation. submersion injury and drowning incidents may escalate. this will be due to lack of supervision of children around storm drains, newly formed bodies of water, or rushing waters of storm diversion systems (sirbaugh and dirocco ) . mental health issues are often seen in children after natural disasters. even though a child may not be injured, they may become "psychiatric casualties" due to the horrific sights they have seen during or after the disaster. children and adolescents with behavioral or psychiatric problems may experience worsening symptoms and signs due to stress, trauma, disruption of routines, or availability of medications. this is often exacerbated if the parent, guardian, caregiver, or hcp is also having difficulty coping with the stress of the disaster. in general, the most common mental health problem in children is a post-traumatic stress disorder. however, separation anxiety, obsessive-compulsive symptoms, and severe stranger anxiety can also be seen in children after a traumatic event (sirbaugh and dirocco ) . see chap. for more detailed information. terrorism impacts children and families all around the world (tables . and . ). after the events of / , much attention has been given to the possibility of another mass casualty act of terrorism, especially with weapons of mass destruction, that include chemical, biological, nuclear, radiological, and explosive devices (cbnre), or other forms of violence such as active shooter incidents and mass shootings (jacobson and severin ) . since then, other incidents, both foreign and domestic, have involved children and complicates the concept of and the response to terrorism. johnston ( ) said it best in his review of terrorist and criminal attacks targeting children: "one of the more accepted defining characteristics of terrorism is that it targets noncombatants including men, women, and children. however, terrorist attacks specifically targeting children over other noncombatants are uncommon. this is for the same reason that most terrorists have historically avoided mass casualty terrorism: the shock value is so great that such attacks erode support for the terrorists' political objectives. the / attacks represent an increasing trend in mass casualty terrorism. at the same time, policymakers are examining this evolving threat, they must increasingly consider the threat of terrorist attacks targeting children." based on historical events, it is clear infants, toddlers, children, and adolescents have been victims of terrorism. this global trend of terrorists targeting children seems to be escalating (johnston ) . therefore, it is imperative to understand terrorism and ways it impacts the children and families served by the health care community. combs ( ) defines terrorism as "an act of violence perpetrated on innocent civilian noncombatants in order to evoke fear in an audience". however, she goes on to argue that to become an operational definition, there must also be the addition of a "political purpose" of the violent act. therefore, "terrorism, then, is an act composed of at least four crucial elements: ) it is an act of violence, ) it has a political motive or goal, ) it is perpetrated against civilian noncombatants, and ) it is staged to be played before an audience whose reaction of fear and terror is the desired result." (combs ) . there are different typologies of terrorism. at least five types of terror violence have been suggested by feliks gross: "mass terror is terror by a state, where the regime coerces the opposition in the population, whether organized or unorganized, sometimes in an institutionalized manner. dynastic assassination is an attack on a head of state or a ruling elite. random terror involves the placing of explosives where people gather (such as post offices, railroads, and cafes) to destroy whoever happens to be there. focused random terror restricts the placing of explosives, for example to where significant agents of oppression are likely to gather. finally, tactical terror is directed solely against the ruling government as a part of a 'broad revolutionary strategic plan'" (combs ). an additional typology offered is "lone wolf terror which involves someone who commits violent acts in support of some group, movement, or ideology, but who does stand alone, outside of any command structure and without material assistance from any group" (combs ) . martin ( ) reviews eight different terrorism typologies in the ever shifting, multifaceted world of modern terrorism. the new terrorism "is characterized by the threat of mass casualty attacks from dissident terrorist organizations, new and creative configurations, transnational religious solidarity, and redefined moral justifications for political violence" (martin ) . state terrorism is "committed by governments against perceived enemies and can be directed externally against adversaries in the international domain or internally against domestic enemies" (martin ) . dissident terrorism is "committed by nonstate movements and groups against governments, ethno-national groups, religious groups, and other perceived enemies" (martin ) . religious terrorism is "motivated by an absolute belief that an otherworldly power has sanctioned and commanded the application of terrorist violence for the greater glory of the faith…[it] is usually conducted in defense of what believers consider to be the one true faith" (martin ) . ideological terrorism is "motivated by political systems of belief (ideologies), which champion the self-perceived inherent rights of a particular group or interest in opposition to another group or interest. the system of belief incorporates theoretical and philosophical justifications for violently asserting the rights of the championed group or interest" (martin ) . international terrorism "spills over onto the world's stage. targets are selected because of their value as symbols of international interests, either within the home country or across state boundaries" (martin ) . criminal dissident terrorism "is solely profit-driven, and can be some combination of profit and politics. for instance, traditional organized criminals accrue profits to fund their criminal activity and for personal interests, while criminalpolitical enterprises acquire profits to sustain their movement" (martin ) . gender-selective terrorism "is directed against an enemy population's men or women because of their gender. systematic violence is directed against men because of the perceived threat posed by males as potential soldiers or sources of opposition. systematic violence is directed against women to destroy an enemy group's cultural identity or terrorize the group into submission" (martin ) . the all-hazards national planning scenarios are an integral component of dhs's capabilities-based approach to implementing homeland security presidential directive : national preparedness (hspd- ). the national planning scenarios are planning tools and are representative of the range of potential terrorist and natural disasters and the related impacts that face the nation. the federal interagency community has developed all-hazards planning scenarios for use in national, federal, state, and local homeland security preparedness activities. the objective was to develop a minimum number of credible scenarios to establish the range of response requirements to facilitate disaster planning (dhs ) (table . ). twelve of the scenarios represent terrorist attacks while three represent natural disasters or naturally occurring epidemics. this ratio reflects the fact that the nation has recurring experience with natural disasters but faces newfound dangers, including the increasing potential for use of weapons of mass destruction by terrorists. the scenarios form the basis for coordinated federal planning, training, exercises, and grant investments needed to prepare for all hazards. dhs employed the scenarios as the basis for a rigorous task analysis of prevention, protection, response, and recovery missions and identification of key tasks that supported the development of essential all-hazards capabilities (united states department of homeland security, federal emergency management agency ) (table . ). each of the scenarios follows the same outline to include a detailed scenario description, planning considerations, and implications. for each of the terrorismrelated scenarios, fema national preparedness directorate (npd) partnered with dhs office of intelligence and analysis (i&a) and other intelligence community and law enforcement experts to develop and validate prevention prequels. the prequels provide an understanding of terrorists' motivation, capability, intent, tactics, techniques and procedures, and technical weapons data. the prequels also provide a credible adversary based on known threats to test the homeland security community's ability to understand and respond to indications and warnings of possible terrorist attacks (united states department of homeland security, federal emergency management agency ). a chemical agent of terrorism is defined as any chemical substance intended for use in military operations to kill, seriously injure, or incapacitate humans (or animals) through its toxicological effects. chemicals excluded from this list are riot-control agents, chemical herbicides, and smoke/flame materials. chemical agents are classified as toxic agents (producing injury or death) or incapacitating agents (producing temporary effects). toxic agents are further described as nerve agents (anticholinesterases), blood agents (cyanogens), blister agents (vesicants), and lung-damaging agents (choking agents). incapacitating agents include stimulants, depressants, psychedelics, and deliriants (banks ; departments of the army, the navy, and the air force, and commandant, marine corps ). nerve agents are organophosphate anticholinesterase compounds. they are used in various insecticide, industrial, and military applications. military-grade agents include tabun (ga), sarin (gb), soman (gd), cyclosarin (gf), venom x (vx), and the novichok series. these are all major military threats. the only known battlefield use of nerve agents was the iraq-iran war. however, other nerve agent incidents, such as the tokyo subway attack (sarin), the chemical attacks in syria (chlorine, sarin, mustard), and the attempted assassination of sergei skripal in salisbury, uk (novichok), support that civilian threats also exist. nerve agents are volatile chemicals and can be released in liquid or vapor form. however, the liquid form can become vapor depending upon its level of volatility (e.g, g-agents are more volatile than vx). the level of toxicity depends on the agent, concentration of the agent, physical form, route and length of exposure, and environmental factors (temperature and wind) (tables . and . ). nerve agents exert their effects by the inhibition of esterase enzymes. acetylcholinesterase inhibition prevents the hydrolysis of acetylcholine. the clinical result is a cholinergic crisis and subsequent overstimulation of muscarinic and nicotinic receptors throughout the body including the central nervous system. clinical muscarinic responses include sludge (salivation, lacrimation, urination, defecation, gastrointestinal distress, and emesis) and dumbels (diarrhea, urinary incontinence, miosis/muscle fasciculation, bronchorrhea/bronchospasm/bradycardia, emesis, lacrimation, and salivation). nicotinic responses vary by site. preganglionic sympathetic nerve stimulation produces mydriasis, tachycardia, hypertension, and pallor. however, stimulation at the neuromuscular junction leads to muscular fasciculation and cramping, weakness, paralysis, and diaphragmatic weakness. central nervous system presentations range from anxiety and restlessness to seizures, coma, and death (banks ; rotenberg and newmark ; rotenberg b ). pediatric manifestations (table . ) may vary from the classic clinical responses due to their unique vulnerabilities (hilmas et al. ): • children may manifest symptoms earliest and possibly more severe presentations. • could be hospitalized for similarly related illnesses and diseases. • smaller mass. • lower baseline cholinesterase activity. • tendency to bronchospasm. • pediatric airway and respiratory differences. • altered pulmonary compensation. • lower reserves of cardiovascular system and fluids. • isolated central nervous system signs (stupor, coma). • less miosis. • vulnerability to seizures and neurotransmitter imbalances (excitability). • immature metabolic systems. differential diagnoses include upper or lower airway obstruction, bronchiolitis, status asthmaticus, cardiogenic shock, acute gastroenteritis, seizures, and poisonings (carbon monoxide, organophosphates, and cyanide). diagnostic tests include acetylcholinesterase levels, red blood cell cholinesterase levels, and an arterial blood gas. treatment (tables . and . ) includes decontamination (reactive skin decontamination lotion ® [potassium , -butanedione monoximate], soap and water, and . % hypochlorite solution), supportive care, and administration of nerve agent antidotes (atropine, pralidoxime chloride, and diazepam). atropine is a competitive antagonist of acetylcholine muscarinic receptors and reverses peripheral muscarinic symptoms. it does not restore function at the neuromuscular junction nicotinic receptors. it does, however, treat early phases of convulsions. pralidoxime chloride separates the nerve agent from acetylcholinesterase and restores enzymatic function. it also binds free nerve agent. the major goal is to prevent "aging" of the enzyme (e.g., gd). diazepam provides treatment of nerve agent-induced seizures and prevents secondary neurologic injury. typically, associated seizures are refractory to other antiepileptic drugs. the antiseizure effect of diazepam is enhanced by atropine (banks ; cieslak and henretig ; messele et al. ) . potential medical countermeasures include trimedoxime (tmb ), hi- (an h-series oxime), obidoxime, "bioscavengers" (butyrylcholinesterase, carboxylesterase, organophosphorus acid anhydride hydrolase, and human serum paraoxonase), novel anticonvulsant drugs, n-methyl-d-aspartate (nmda) receptor antagonists (ketamine, dexanabinol), and common immunosuppressants such as cyclosporine a (jokanovic ; merrill et al. ; national institutes of health ; united states department of health and human services ). all patients should be observed closely for electroencephalographic changes and neuropsychiatric pathologies. polyneuropathy, reported after organophosphate insecticide poisoning, has not been reported in humans exposed to nerve agents and has been produced in animals only at unsurvivable doses. the intermediate syndrome has not been reported in humans after nerve agent exposure, nor has it been produced in animals. muscular necrosis has occurred in animals after high-dose nerve agent exposure but reversed within weeks; it has not been reported in humans (banks ). on march , , sergei skripal, a former russian double agent, and his daughter, yulia skripal, were found unresponsive on a park bench in salisbury, uk. they were brought to a nearby hospital and treated for signs consistent with a cholinergic crisis due to a nerve agent exposure. analysis of the skripals found the presence of a secret nerve agent called novichok. further testing found high concentrations of the agent on the front-door handle of his home. one of the investigating police officers, detective sergeant nick bailey, unknowingly touched the door-handle and also became ill. all three survived due to rapid recognition of the nerve agent exposure by hospital personnel. four months later, two other people, dawn sturgess and charlie rowley, became ill with identical symptoms in the town of amesbury, miles from salisbury. they were later confirmed to have high concentrations of novichok on their hands from a perfume bottle found in a recycling bin. both were immediately treated, but dawn sturgess later died. charlie rowley survived. it was believed the discarded perfume bottle contained novichok and was discarded by the assailants after the attempt on sergei skripal. on september , , the uk government revealed that their investigation uncovered two suspects from closed circuit television (cctv) footage near the skripal's home. the suspects entered the uk on russian passports using the names alexander petrov and ruslan boshirov, stayed in a london hotel for days, visited salisbury briefly, and then returned to moscow. minute traces of novichok were also found in the london hotel where they had stayed. the uk prime minister, teresa may, said that the suspects are thought to be officers from russia's military intelligence service the glavnoye razvedyvatel'noye upravleniye (gru), and that this showed that the poisoning was "not a rogue operation" and was "almost certainly" approved at a senior level of the russian state. the two suspects later appeared on russian tv denying the accusations and saying they were just "tourists" who had traveled all the way from moscow to salisbury just to see the "famous cathedral". however, cctv of the cathedral area found no evidence of the two men visiting the cathedral, although they were captured on cctv near the skripal's home. in a development in september , one of the men was revealed as actually being a russian intelligence officer named colonel anatoliy chepiga and was a decorated veteran of russian campaigns in chechnya and ukraine. and later in october, the second man was named as dr. alexander mishkin, a naval medical doctor allegedly recruited by the gru (chai et al. ; may ) . novichok (Новичоќ: russian for "newcomer") is a highly potent nerve agent developed from the russian classified nerve agent program known as foliant. almost everything known about these agents is due to a russian defector, vil mirzayanov ( ) who was an analytical chemist at the russian state research institute of organic chemistry and technology (gosniiokht). he has described the details of the novichok program in his book "state secrets: an insider's chronicle of the russian chemical weapons program". the first three nerve agents of the novichok series developed in the program were substance- , a- , and a- (table . ). they were synthesized as unitary agents, like vx, tabun, soman, and sarin. unitary means that the chemical structure was produced at its maximum potency. however, the novichok agents were developed as binary agents: maximum potency when two inert substances are combined together prior to deployment to create the active nerve agent (cieslak and henretig ) . very little is known about the chemistry of these weaponized organophosphate agents. however, they appear to be more potent than current nerve agents. for example, the ld of novichok agents is reported . μg/kg similar to -(dimethylamino)ethyl n,n-dimethylphosphoramidofluoridate (vg), a novel fourth generation nerve agent. furthermore, novichok- is × more effective than vx and novichock- is × more effective than soman (cieslak and henretig ; hoenig ) . clinically, they behave like other organophosphates by binding to acetylcholinesterase preventing the breakdown of acetylcholine thereby leading to a cholinergic crisis. there appears to be a similar "aging" process as seen with other nerve agents. in addition, the novichok agents binding to peripheral sensory nerves distinguishes this class of organophosphates. prolonged or high-dose exposure results in debilitating peripheral neuropathy. exposure to these agents is fatal unless aggressively managed (cieslak and henretig ) . decontamination is essential to prevent ongoing exposure to the patient and medical personnel. clothing should be removed and quickly placed in a sealed bag (prevents ongoing exposure to the emission of vapors) followed by thorough washing with soap and water. application of dry bleach powder should be avoided as it may hydrolyze nerve agents into toxic metabolites that can produce ongoing cholinergic effects. supportive care is essential. antidote therapy should be given as usual for nerve agents, including atropine, diazepam, and pralidoxime chloride (united states department of health and human services, office of the assistant secretary for preparedness and response, national library of medicine ; united states department of health and human services, chemical hazards emergency medical management (chemm) ). of note, the toxicity of the novichok agents may not rely on anticholinesterase inhibition. some have suggested that reactive oximes like potassium , -butanedione monoximate are preferred oximes for antidotal therapy (cieslak and henretig ) . cyanide is a naturally occurring chemical. it can be found in plants and seeds. it is also used in many industrial applications and is a common product of combustion of synthetic materials. typical cyanogens include hydrogen cyanide (ac) and cyanogen chloride (ck). low levels of cyanide are detoxified by a natural reaction in the human body using the rhodanese system. there is reversible metabolism with vitamin b a to vitamin b (cyanocobalamin). an irreversible reaction occurs with sulfanes to produce thiocyanates and sulfates. the former is excreted via the urinary tract. when cyanide overwhelms this natural process, cyanide binds to ( ) a vx = venom x (cieslak and henretig ) cytochrome oxidase within the mitochondria and disrupts cellular respiration. cyanide has an affinity for fe+ in the cytochrome a complex and oxidative phosphorylation is interrupted. cells can no longer use oxygen to produce atp and lactic acidosis ensues from resultant anaerobic metabolism. when inhaled, cyanide produces rapid onset of clinical signs. findings include transient tachypnea and kussmaul breathing (from hypoxia of carotid and aortic bodies), hypertension and tachycardia (from hypoxia of aortic body), and neurologic findings such as seizures, muscle rigidity (trismus), opisthotonus, and decerebrate posturing. other findings include cherry red flush, acute respiratory failure/ arrest, bradycardia, dissociative shock, and cardiac arrest. venous blood samples exhibit a bright red color. arterial blood gas may demonstrate a metabolic acidosis with an increased anion gap due to lactic acid (banks ; cieslak and henretig ; rotenberg a) . pediatric manifestations (table . ) may vary from the classic clinical responses due to their unique vulnerabilities (hilmas et al. ): • thinner integument leading to shorter time from exposure to symptom development. • higher vapor density (ck) and concentration accumulation in living zone of children, • higher minute ventilation and metabolism. • abdominal pain, nausea, restlessness, and giddiness are common early findings. • cyanosis mostly noted other than classic cherry red flushing of the skin. • resilient with recovery even when just using supportive measures alone. differential diagnoses include meningitis, encephalitis, gastroenteritis, ischemic stroke, methemoglobinemia, and poisonings (nerve agents, organophosphates, methanol, hydrogen sulfide, and carbon monoxide). diagnostic tests include arterial blood gas, lactic acid, and thiocyanate levels. treatment (tables . and . ) includes decontamination, supportive care, and administration of cyanide antidote kit (nitrites and thiosulfate). the nitrites facilitate the production of methemoglobinemia (fe+ ) which attracts cyanide molecules forming cyanmethemoglobin. amyl nitrite pearls are crushed into gauze and placed over the mouth/nose or in a mask used for bag/mask ventilation. sodium nitrite is given parenterally and dosed according to the patient's estimated hemoglobin so as to prevent severe methemoglobinemia. since the formation of cyanmethemoglobin is a reversible reaction, and sodium thiosulfate is given to extract the cyanide. dosing is also dependent upon estimated hemoglobin. along with the naturally occurring rhodanese enzymatic system, the irreversible reaction forms thiocyanate. thiocyanate is water soluble and is excreted harmlessly via the kidneys (banks ; cieslak and henretig ). potential medical countermeasures (national institutes of health ; united states army medical research institute of infectious diseases (usamriid) ) include hydroxocobalamin, cobinamide (a cobalamin precursor), dicobalt edetate, cyanohydrin-forming compounds (alpha-ketoglutarate and pyruvate), s-substituted crystallized rhodanese, sulfur-containing drugs (n-acetylcysteine), and methemoglobin inducers ( -dimethylaminophenol and others). blistering agents, or vesicants, promote the production of blisters. typical examples include sulfur mustard (hd), nitrogen mustard (hn), and lewisite (l). these agents, especially sulfur mustard, are considered capable chemical weapons since illness may not occur until hours or days later. vesicants are alkylating agents that affect rapidly reproducing and poorly differentiated cells in the body. however, they can also produce cellular oxidative stress, deplete glutathione stores, and promote immature cognitive function unable to flee emergency immature coping mechanisms inability to discern threat, follow directions, and protect self high risk for developing ptsd bbb blood-brain barrier, bsa body surface area, cns central nervous system, ptsd post-traumatic stress disorder (hilmas et al. ) intense inflammatory responses. clinical findings are initially cutaneous (erythema, pruritus, yellow blisters, ulcers, and sloughing), respiratory (hoarseness, cough, voice changes, pneumonia, respiratory failure, acute lung injury, and acute respiratory distress syndrome), and ophthalmologic (pain, irritation, blepharospasm, photophobia, conjunctivitis, corneal ulceration, and globe perforation) in nature. after exposure through these primary portals of entry, other sites are affected, including the gastrointestinal tract (nausea, vomiting, and mucosal injury), the hematopoietic system (bone marrow suppression), the cardiovascular system (l), reproductive system (hd, hn) , and the central nervous system (lethargy, headache, malaise, and depression) (banks ; yu et al. ) . pediatric manifestations (table . ) may vary from the classic clinical responses due to their unique vulnerabilities (hilmas et al. ): • thinner integument leading to shorter time from exposure to symptom development. • higher vapor density and concentration accumulation in the living zone. • higher minute ventilation and metabolism. • greater pulmonary injury. • ocular findings more frequent (less self-protection and more hand/eye contact). • gastrointestinal manifestations more prominent. • unable to escape and decontaminate. • unable to verbalize complaints (i.e., pain). treatment (tables . and . ) includes decontamination and supportive care. currently, there are no antidotes for mustard toxicity (cieslak and henretig ) . agents under investigation include antioxidants (vitamin e), anti-inflammatory drugs (corticosteroids), mustard scavengers (glutathione, n-acetylcysteine), and nitric oxide synthase inhibitors (l-nitroarginine methyl ester). other therapeutics under investigation include the use of british anti-lewisite (bal), reactive skin protectants, and ocular therapies (national institutes of health ; usamriid ). lung-damaging agents are toxic inhalants and potentially can affect the entire respiratory tract. typical examples include chlorine (cl ), phosgene (carbonyl chloride), oxides of nitrogen, organofluoride polymers, hydrogen fluoride, and zinc oxide. since many of these chemicals are readily available and have multiple industrial applications, they are considered terrorist weapons of opportunity. toxicity is dependent upon agent particle size, solubility, and method of release. large particles produce injury in the nasopharynx (sneezing, pain, and erythema). midsize particles affect the central airways (painful swelling, cough, stridor, wheezing, and rhonchi). small particles cause injury at the level of the alveoli (dyspnea, chest tightness, and rales). highly soluble agents, such as chlorine, dissolve with mucosal moisture and immediately produce strong upper airway reactions. less soluble agents, such as phosgene, travel to the lower airway before dissolving and subsequently causing toxicity. it is important, however, to realize that very few lungdamaging agents affect only the upper or lower airway (e.g., cl ). if the agent is aerosolized, solid or liquid droplets suspend in the air and distribute by size. if it is a gas or vapor release, there is uniform distribution throughout the lungs and toxicity will be based on solubility and reactivity of the agent (banks ; burklow et al. ; cieslak and henretig ) . pediatric manifestations (table . ) may vary from the classic clinical responses due to their unique vulnerabilities (hilmas et al. ): • pediatric airway and respiratory tract issues (obligate nose breathers, relatively small mouth/large tongue, copious secretions, anterior/cephalad vocal cords, omega or horseshoe-shaped epiglottis, tendency of laryngospasm and bronchospasm, and anatomically small, "floppy" airways). • high vapor density and concentration accumulation in the living zone. • unable to verbalize or localize physical complaints. • rapid dehydration and shock secondary to pulmonary edema. • increased minute ventilation and metabolism. differential diagnoses include smoke inhalation injury, cardiogenic shock, heart failure, traumatic injury, asthma, bronchiolitis, and poisoning (cyanide). treatment (tables . and . ) includes decontamination and supportive care. currently, there are no antidotes for lung-damaging agent toxicity (cieslak and henretig ) . potential countermeasures include novel positive-pressure devices, drugs to prevent lung inflammation, and treatments for chemically induced pulmonary edema (beta agonists, dopamine, insulin, allopurinol, and ibuprofen). in addition, drugs are being investigated that act at complex molecular pathways of the lung the centers for disease control and prevention (cdc) has delineated bioterrorism agents and diseases into three categories based on priority. category a agents include organisms with the highest risk because the ease of dissemination or transmission from person-to-person, result in high mortality rates, have the potential for major public health impact, promote public panic and social disruption, and require special action of public health preparedness. these agents/diseases include smallpox (variola major), anthrax (bacillus anthracis), plague (yersinia pestis), viral hemorrhagic fevers (filoviruses [ebola, marburg] and arenaviruses [lassa, macupo]), botulinum toxin (from clostridium botulinum), and tularemia (francisella tularensis). category b agents, the second highest priority, include those that are moderately easy to disseminate, result in moderate morbidity and low mortality rates, and require specific enhancements of diagnostic capacity and enhanced disease surveillance. these agents/diseases include ricin toxin (ricinus communis), brucellosis (brucella species), epsilon toxin of clostridium perfringens, food safety threats (salmonella species, escherichia coli o :h , shigella), glanders (burkholderia mallei), meliodosis (burkholderia pseudomallei), psitticosis (chlamydia psittaci), typhus fever (rickettsia prowazekii), q fever (coxiella burnetii), staphylococcal enterotoxin b, trichothecenes mycotoxin, viral encephalitis (alphaviruses, such as eastern equine encephalitis, venezuelan equine encephalitis, and western equine encephalitis), and water safety threats (vibrio cholera, cryptosporidium parvum). category c agents have the next priority and include emerging pathogens that could be engineered for mass dissemination because of availability, ease of production and dissemination, and have the potential for high morbidity and mortality rates and major health impact. recognition of a biologic attack is essential. there are various epidemiologic clues to consider when determining whether the outbreak is natural or man-made (markenson et al. ; cieslak ; usamriid ) : • the appearance of a large outbreak of cases of a similar disease or syndrome, or especially in a discrete population. • many cases of unexplained diseases or deaths. • more severe disease than is usually expected for a specific pathogen or failure to respond to standard therapy. • unusual routes of exposure for a pathogen, such as the inhalational route for disease that normally occur through other exposures. • a disease case or cases that are unusual for a given geographic area or transmission season. • disease normally transmitted by a vector that is not present in the local area. • multiple simultaneous or serial epidemics of different diseases in the same population. • a single case of disease by an uncommon agent (smallpox, some viral hemorrhagic fevers, inhalational anthrax, pneumonic plague). • a disease that is unusual for an age group. • unusual strains or variants of organisms or antimicrobial resistance patterns different from those known to be circulating. • a similar or identical genetic type among agents isolated from distinct sources at different times and/or locations. • higher attack rates among those exposed in certain areas, such as inside a building if released indoors, or lower rates in those inside a sealed building if released outside. • outbreaks of the same disease occurring in noncontiguous areas. • zoonotic disease outbreaks. • intelligence of a potential attack, claims by a terrorist or aggressor of a release, and discovery of munitions, tampering, or other potential vehicle of spread (spray device, contaminated letter). one should know the cellular, physiological, and clinical manifestations of each biologic agent. furthermore, knowledge of distinct presentation patterns of children will be helpful to diagnosis. in any event, the ten steps in the management of biologic attack victims, pediatric, or otherwise, should be applied (cieslak and henretig ; cieslak ; usamriid smallpox is caused by the orthopoxvirus variola and was declared globally eradicated in . the disease is highly communicable from person-to-person and remains a threat due to its potential for weaponization. the only stockpiles are at the cdc and at the russian state centre for research on virology and biotechnology. however, clandestine stockpiles in other parts of the world are unknown. since the cessation of smallpox vaccination, the general population has little or no immunity. the three clinical forms of smallpox include ordinary, flat, and hemorrhagic. another form, modified type, occurred in those previously vaccinated who were no longer protected. the asymptomatic incubation period is from to days (average days) after exposure. a prodrome follows that lasts for - days and is marked by fever, malaise, and myalgia. lesions start on the buccal and pharyngeal mucosa. the rash then spreads in a centrifugal fashion, and the lesions are synchronous. initially, there are macules followed by papules, pustules, and scabs in - weeks. other clinical features include extensive fluid loss and hypovolemic shock, nausea, vomiting, diarrhea, bacterial superinfections, viral bronchitis and pneumonitis, corneal ulceration with or without keratitis, and encephalitis. death, if it occurs, is typically during the second week of clinical disease. variola minor caused a mortality of % in unvaccinated individuals. however, the variola major type caused death in % and % in those vaccinated and unvaccinated, respectively. flat (mostly children) and hemorrhagic (pregnant women and immunocompromised) types caused severe mortality in those populations infected. the differential diagnoses for smallpox include chickenpox (varicella), herpes, erythema multiforme with bullae, or allergic contact dermatitis. varicella typically has a longer incubation period ( - days) and minimal or no prodrome. furthermore, the rash distributes in a centripetal fashion and the progression is asynchronous (images . and . ). diagnosis of smallpox is mostly clinical (centers for disease control and prevention a). if considered, contact public health immediately. laboratory confirmation (cdc or who) can be done by dna sequencing, polymerase chain reaction (pcr), restriction fragment-length polymorphism (rflp), real-time pcr, and microarrays. these are more sensitive and specific than the conventional virological and immunological approaches (goff et al. ) . generally, treatment is largely supportive (table . ). fluid losses and hypovolemic shock must be addressed. also, due to electrolyte and protein loss, replacement therapy will be required. bacterial superinfections must be aggressively treated with appropriate antibiotics. biologic countermeasures and antivirals against smallpox are under investigation, including cidofovir, brincidovir (cmx- ), and tecovirimat (st- ). these agents have shown efficacy in orthopoxvirus animal models and have been used to treat disseminated vaccinia infection under emergency use. cidofovir has activity against poxviruses in animal studies (in vitro and in vivo) and some humans (eczema vaccinatum and molluscum contagiosum). brincidovir is an oral formulation of cidofovir with less nephrotoxicity and has recently been announced as an addition to the strategic national stockpile (sns) for patients with smallpox. tecovirimat is a potent and specific inhibitor of orthopoxvirus replication. a recent study found that treatment with tecovirimat resulted in % survival of cynomolgus macaques challenged with intravenous variola virus. the disease was milder in tecovirimat-treated survivors and viral shedding was reduced compared to placebo-treated survivors. prophylaxis comes in the form of the smallpox vaccine (vaccinia virus), acam ® , which replaced wyeth dryvax™ in . safety profile of the two vaccines appears to be similar. side effects of vaccination range from low-grade fever and axillary lymphadenopathy to inadvertent inoculation of the virus to other body sites to generalized vaccinia and cardiac events (myopericarditis). rare, but typically fatal complications include progressive vaccinia, eczema vaccinatum, postvaccination encephalomyelitis, and fetal vaccinia. modified vaccinia ankara (mva) smallpox vaccine (bavarian nordic's imvamune ® ) is a live, highly attenuated, viral vaccine that is under development as a future nonreplicating smallpox vaccine (greenberg et al. ; kennedy and greenberg ). passive immunoprophylaxis exists in the form of vaccinia immune globulin (vig) and is used for primarily treating complications from smallpox vaccine. limited information suggests that vig may be of use in postexposure prophylaxis of smallpox if given the first week after exposure and with vaccination. monoclonal antibodies may represent another form of immunoprophylaxis. postexposure administration of human monoclonal antibodies has protected rabbits from a lethal dose of an orthopoxvirus. as mentioned, smallpox is highly communicable person-to-person (table . ). contact precautions with full personal protective equipment (ppe) are required. airborne isolation with the use of an n- mask is needed for baseline protection. an n- mask or powered airpurifying respirator (papr) is recommended for protection during high risk procedures (beigel and sandrock ; goff et al. ; rotz et al. ; pittman et al. ; usamriid ). anthrax is caused by the aerobic, spore-forming, nonmotile, encapsulated gram-positive rod bacillus anthracis. it is a naturally occurring disease in herbivores. humans contract the illness by handling contaminated portions of infected animals, especially hides and wool. infection is introduced by scratches or abrasions on the skin. there is concern for potential aerosol dispersal leading to intentional infection through inhalation: it is fairly easy to obtain, capable of large quantity production, stable in aerosol form, and highly lethal. anthrax spores enter the body via skin, ingestion, or inhalation. the spores germinate inside macrophages and become vegetative bacteria. the vegetative form is released, replicates in the lymphatic system, and produces intense bacteremia. the production of virulence factors leads to overwhelming sepsis. the main virulence factors are encoded on two plasmids. one produces an antiphagocytic polypeptide capsule. the other contains genes for the synthesis of three proteins it secretes: protective antigen, edema factor, and lethal factor. the combination of protective antigen with lethal factor or edema factor forms binary cytotoxins, lethal toxin, and edema toxin. the anthrax capsule, lethal toxin, and edema toxin act in concert to drive the disease. three clinical syndromes occur with anthrax: cutaneous, gastrointestinal, and inhalational. cutaneous anthrax is the most common naturally occurring form. after an individual is exposed to infected material or the agent itself, there is a - day (average days) incubation period. a painless or pruritic papule forms at the site of exposure. the papule enlarges and forms a central vesicle, which is followed by erosion into a coal-black but painless eschar. edema surrounds the area and regional lymphadenopathy may occur. gastrointestinal anthrax is rare. typically, it develops after ingestion of viable vegetative organisms found in undercooked meats of infected animals. the two forms of gastrointestinal anthrax, oropharyngeal and intestinal, have incubation periods of - days. the oropharyngeal form is marked by fever and severe pharyngitis followed by ulcers and pseudomembrane formation. other findings include dysphagia, regional lymphadenopathy, unilateral neck swelling, airway compromise, and sepsis. the intestinal form begins with fever, nausea, vomiting, and abdominal pain. bowel edema develops which leads to mesenteric lymphadenitis with necrosis, shock, and death. endemic inhalational anthrax (woolsorters' disease) is also extremely rare and is due to inhaling spores. therefore, any case of inhalational anthrax should be assumed to be due to intentional exposure until proven otherwise. the incubation period is - days but can be up to days. there is a prodrome of - days consisting of fever, malaise, and cough. within h, the disease rapidly progresses to respiratory failure, hemorrhagic mediastinitis (wide mediastinum), septic shock, multiorgan failure, and death. patients with inhalational anthrax may also have hemorrhagic meningitis. mortality is greater than % in - h despite aggressive treatment of inhalational anthrax. the differential diagnoses of ulceroglandular lesions include antiphospholipid antibody syndrome, brown recluse spider bite, coumadin/heparin necrosis, cutaneous leishmaniasis, cutaneous tuberculosis, ecthyma gangrenosum, glanders, leprosy, mucormycosis, orf, plague, rat bite fever, rickettsial pox, staphylococcal/ streptococcal ecthyma, tropical ulcer, tularemia, and typhus. the differential diagnoses of ulceroglandular syndromes include cat scratch fever, chancroid, glanders, herpes, lymphogranuloma venereum, melioidosis, plague, staphylococcal and streptococcal adenitis, tuberculosis, and tularemia. the differential diagnoses for inhalational anthrax include influenza and influenza-like illnesses from other causes. the differential diagnoses of mediastinal widening include normal variant, aneurysm, histoplasmosis, sarcoidosis, tuberculosis, and lymphoma. the diagnosis of anthrax is by culture and gram stain of the blood, sputum, pleural fluid, cerebrospinal fluid, or skin. specimens must be handled carefully, especially by lab personnel and those performing autopsies. elisa and pcr are available at some reference laboratories. the chest radiograph of inhalational anthrax shows the classic widening of the mediastinum. additional findings include hemorrhagic pleural effusions, air bronchograms, and/or consolidation (purcell et al. ). supportive treatment is indicated, including mechanical ventilation, pleural effusion drainage, fluid and electrolyte support, and vasopressor administration. for inhalational anthrax, antibiotic treatment is unlikely to be effective unless started before respiratory symptoms develop. treatment (table . ) includes ciprofloxacin (or levofloxacin or doxycycline), clindamycin, and penicillin g. raxibacumab, a monoclonal antibody, was approved by the fda in for the treatment of inhalational anthrax in combination with recommended antibiotic regimens and prophylaxis for inhalational anthrax when other therapies are unavailable or inappropriate. it works by inhibiting anthrax antigen binding to cells and, therefore, prevents toxins from entering cells (kummerfeldt ) . the adult dose is mg/kg given iv over h and min. the dose for children is weight based; ≤ kg: mg/kg; > - kg: mg/kg; > kg: mg/kg. premedication with diphenhydramine iv or po is recommended h before the infusion. it can also be used as postexposure prophylaxis in high risk spore exposure cases (cieslak and henretig ; migone et al. ; the medical letter ). obiltoxaximab (anthim) is a recently approved monoclonal antibody treatment for inhalational anthrax in combination with recommended antibiotic regimens and prophylaxis for inhalational anthrax when other therapies are unavailable or inappropriate. adults and children > kg should receive a single obiltoxaximab dose of mg/kg. the recommended dose is mg/kg for children > - kg and mg/kg for those weighing ≤ kg. premedication with diphenhydramine is recommended to reduce risk of hypersensitivity reactions (the medical letter ). in patients with inhalational anthrax, intravenous anthrax immune globulin (anthrasil) should be considered in addition to appropriate antibiotic therapy (mytle et al. ; the medical letter ; usamriid ). postexposure prophylaxis includes ciprofloxacin (or levofloxacin or doxycycline) for days plus administration of vaccine; since spores can persist in human in addition to appropriate antibiotic regimen, monoclonal antibody therapy (see text for dosing) and intravenous anthrax immune globulin should be administered for inhalational anthrax c levofloxacin or ofloxacin may be an acceptable alternative to ciprofloxacin d rifampin or clarithromycin may be acceptable alternatives to clindamycin as a drug that targets bacterial protein synthesis. if ciprofloxacin or another quinolone is employed, doxycycline may be used as a second agent because it also targets protein synthesis e ampicillin, imipenem, meropenem, or chloramphenicol may be acceptable alternatives to penicillin as drugs with good cns penetration f assuming the organism is sensitive, children may be switched to oral amoxicillin ( - mg/kg/d divided q h) to complete a -day course. the first days of therapy of postexposure prophylaxis, however, should include ciprofloxacin or levofloxacin and/or doxycycline regardless of age. vaccination should also be provided; if not, antibiotic course will need to be longer g according to most experts, ciprofloxacin is the preferred agent for oral prophylaxis h ten days of therapy may be adequate for endemic cutaneous disease. a full -day course is recommended in the setting of terrorism, however, because of the possibility of concomitant inhalational exposure tissues for a long time, antibiotics must be given for a longer period if vaccine is not also given. the anthrax vaccine adsorbed (ava biothrax™) is derived from sterile culture fluid supernatant taken from an attenuated strain of bacillus anthracis and does not contain any live or dead organisms. the vaccine is given . ml intramuscularly at and weeks then at , , and months followed by yearly boosters (pittman et al. ; usamriid ) . consult with cdc for current pediatric recommendations. anthrax is not contagious in the vegetative form during clinical illness (table . ). contact with infected animals increases likelihood of spread. therefore, contact should be limited and the use of appropriate ppe in endemic areas is indicated (beigel and sandrock ; purcell et al. ; usamriid ) . plague is caused by yersinia pestis, a nonmotile, nonsporulating gram-negative bacterium. it is a zoonotic disease of rodents. it is typically found worldwide and is endemic in western and southwestern states. humans develop the disease after contact with infected rodents, or being bitten by their fleas. after a rodent population dies off, the fleas search for other sources of blood, namely humans. this is when large outbreaks of human plague occur. pneumonic plague is a very rare disease and when it is present in a patient, it may be highly suspicious for intentional dispersal of this deadly agent. three clinical syndromes occur with plague: bubonic plague ( %), septicemic plague ( %), and primary pneumonic plague ( - %). bubonic plague occurs after an infected flea bites a human. after an incubation period of - days, there is onset of high fever, severe malaise, headache, myalgias, and nausea with vomiting. almost % have abdominal pain. around the same time, a characteristic bubo forms which is tender, erythematous, and edematous without fluctuation. buboes typically form in the femoral or inguinal lymph nodes, but other areas can be involved as well (axillary, intraabdominal). the spleen and liver can be tender and palpable. the disease disseminates without therapy. severe complications can ensue, including pneumonia, meningitis, sepsis, and multiorgan failure. pneumonia is particularly concerning since these patients are extremely contagious. mortality of untreated bubonic plague is %, but % with efficient and effective treatment. septicemic plague is characterized by acute fever followed by sepsis without bubo formation. the clinical syndrome is very similar to other forms of gram-negative sepsis: chills, malaise, tachycardia, tachypnea, hypotension, nausea, vomiting, and diarrhea. in addition to sepsis, disseminated intravascular coagulation can ensue leading to thrombosis, necrosis, gangrene, and the formation of black appendages. multiorgan failure can quickly follow. untreated septicemic plague is almost % fatal versus - % in those treated. pneumonic plague is very rare and should be considered due to an intentional aerosol release until proven otherwise. the incubation period is relatively short at - days. sudden fever, cough, and respiratory failure quickly follow. this form produces a fulminant pneumonia with watery sputum that usually progresses to bloody. within a short period of time, septic shock and disseminated intravascular coagulation develop. ards and death may occur. mortality rate of pneumonic plague is very high but may respond to early treatment. plague meningitis is a rare complication of plague. it can occur in % of patients with septicemia and pneumonic forms and is more common in children. usually occurring a few weeks into the illness, it affects those receiving subtherapeutic doses of antibiotics or bacteriostatic antibiotics that do not cross the blood-brain barrier (tetracyclines). fever, meningismus, and other meningeal signs occur. plague meningitis is virtually indistinguishable from meningococcemia. the differential diagnoses of bubonic plague include tularemia, cat scratch fever, lymphogranuloma venereum, chancroid, scrub typhus, and other staphylococcal and streptococcal infections. the differential diagnoses of septicemic plague should include meningococcemia, other forms of gram-negative sepsis, and rickettsial diseases. the differential diagnosis of pneumonic plague is very broad. however, sudden appearance of previously healthy individuals with rapidly progressive gram-negative pneumonia with hemoptysis should strongly suggest pneumonic plague due to intentional release. diagnosis can be made clinically as previously described. demonstration of yersinia pestis in blood or sputum is paramount. methylene blue or wright's stain of exudates may reveal the classic safety-pin appearance of yersinia pestis. culture on sheep blood or macconkey agar demonstrates beaten-copper colonies ( h) followed by fried-egg colonies ( h). detection of yersinia pestis f -antigen by specific immunoassay is available, but the result is available retrospectively. chest radiograph of patients will demonstrate patchy infiltrates (centers for disease control and prevention a; worsham et al. ) . treatment includes mechanical ventilation strategies for ards, hemodynamic support (fluid and vasopressor administration), and antimicrobial agents (table . ). gentamicin or streptomycin is the preferred antimicrobial treatment. alternatives include doxycycline or ciprofloxacin or levofloxacin or chloramphenicol. in cases of meningitis, chloramphenicol is recommended due to its ability to effectively cross the blood-brain barrier. streptomycin is in limited supply and is available for compassionate use. it should be avoided in pregnant women. postexposure prophylaxis includes doxycycline or ciprofloxacin. no licensed plague vaccine is currently in production. a previous licensed vaccine was used in the past. it only offered protection against bubonic plague but not aerosolized yersinia pestis. the plague bacterium secretes several virulence factors (fraction (f ) and v (virulence) proteins) that as subunit proteins are immunogenic and possess protective properties. recently, an f -v antigen (fusion protein) vaccine developed by usamriid provided % protection in monkeys against high-dose aerosol challenge. there is no passive immunoprophylaxis (i.e., immune globulin) available for pre-or postexposure of plague (usamriid ). use of standard precautions for patients with bubonic and septicemic plague is indicated. suspected pneumonic plague will require strict isolation with respiratory droplet precautions for at least h after initiation of effective antimicrobial therapy, or until sputum cultures are negative in confirmed cases. an n- respirator should be used for baseline protection (table . ). it is also recommended to use an n- respirator or papr for high risk procedures (beigel and sandrock ; ; centers for disease control and prevention ; centers for disease control and prevention b; pittman et al. ; usamriid ) . in a mass casualty setting, parenteral therapy might not be possible. in such cases, oral therapy (with analogous agents) may need to be used b ofloxacin (and possibly other quinolones) may be acceptable alternatives to ciprofloxacin or levofloxacin; however, they are not approved for use in children c concentration should be maintained between and μg/ml. some experts have recommended that chloramphenicol be used to treat patients with plague meningitis, because chloramphenicol penetrates the blood-brain barrier. use in children younger than may be associated with adverse reactions but might be warranted for serious infections d ribavirin is recommended for arenavirus or bunyavirus infections and may be indicated for a viral hemorrhagic fever of an unknown etiology although not fda approved for these indications. for intravenous therapy use a loading dose: kg iv once (max dose, g), then mg/kg iv q h for days (max dose, g), and then mg/kg iv q h for days (max dose, mg). in a mass casualty setting, it may be necessary to use oral therapy. for oral therapy, use a loading dose of mg/kg po once, then mg/kg/day po in divided doses for days viral hemorrhagic fever has a variety of causative agents. however, the syndromes they produce are characterized by fever and bleeding diathesis. the etiologies include rna viruses from four distinct families: arenaviridae, bunyaviridae, filoviridae, and flaviviridae. the filoviridae (includes ebola and marburg) and arenaviridae (includes lassa fever and new world viruses) are category a agents. based on multiple identified characteristics, there is strong concern for the weaponization potential of the viral hemorrhagic fevers. specifically, there has been demonstration of high contagiousness in aerosolized primate models. there are five identified ebola species, but only four are known to cause disease in humans. the natural reservoir host of ebola virus remains unknown. however, on the basis of evidence and the nature of similar viruses, researchers believe that the virus is animal-borne and that bats are the most likely reservoir. four of the five virus strains occur in an animal host native to africa. marburg virus has a single species. geographic distribution of ebola and marburg is africa (fitzgerald et al. ). both diseases are very similar clinically. incubation period is typically - days with a range of - days. symptoms may include fever, chills, headache, myalgia, nausea, and vomiting. there is rapid progression to prostration, stupor, and hypotension. the onset of a maculopapular rash on the arms and trunk is classic. disseminated intravascular coagulation and thrombocytopenia develops with conjunctival injection, petechiae, hemorrhage, and soft tissue bleeding. there is a possible central nervous system and hepatic involvement. bleeding, uncompensated shock, and multiorgan failure are seen. high viral load early in course is associated with poor prognosis. death usually occurs during the second week of illness. mortality rate of marburg is - % and for ebola - %. in a retrospective cohort study of children during the / ebola outbreak in liberia and sierra leone (all less than years with a median age of years with one-third less than years of age), the most common features upon presentation were fever, weakness, anorexia, and diarrhea. about % were initially afebrile. bleeding was rare upon initial presentation. the overall case fatality rate was %. factors associated with death included children less than years of age, bleeding at any time during hospitalization, and high viral load (smit et al. ) . in another retrospective cohort study of children at two ebola centers in sierra leone in (all less than years of age), presenting symptoms included weakness, fever, anorexia, diarrhea, and cough. about % were afebrile on presentation. the case fatality rate was higher in children less than years ( %) versus - years of age ( %) and times more likely to die if child had a higher viral load. signs associated with death included fever, emesis, and diarrhea. interestingly, hiccups, bleeding, and confusion were only observed in children who died (shah et al. ) . lassa virus and new world viruses (junin, machupo, sabia, and guanarito) are transmitted from person-to-person. the vector in nature is the rodent. the incubation period is from to days. the geographical distribution is west africa and south america, respectively. the south american hemorrhagic fevers are quite similar but differ from lassa fever. the onset of the south american viruses is insidious and results in high fever and constitutional symptoms. petechiae or vesicular enanthem with conjunctival injection is common. these fevers are associated with neurologic disease (hyporeflexia, gait abnormalities, and cerebellar dysfunction). seizures portend a poor prognosis. mortality ranges from % to over %. on the contrary, lassa viruses are mild. less than % of infections result in severe disease. signs include chest pain, sore throat, and proteinuria. hemorrhagic disease is uncommon. other features include neurologic disease such as encephalitis, meningitis, cerebellar disease, and cranial nerve viii deafness (common feature). mortality can be as high as %. differential diagnoses include malaria, meningococcemia, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, and typhoid fever. diagnosis is through detection of the viral antigen testing by elisa or viral isolation by culture at the cdc. no specific therapy is present and generally involves supportive care, especially mechanical ventilation strategies for ards, hemodynamic support, and renal replacement therapy. for the arenaviridae and bunyaviridae groups, ribavirin may be indicated ( (pittman et al. ) . there is no current vaccine for ebola that is licensed by the fda. an experimental vaccine called rvsv-zebov was found to be highly protective against ebola virus in a trial conducted by the world health organization (who) and other international partners in guinea in . fda licensure for the vaccine is expected in . until then, , doses have been committed for an emergency use stockpile under the appropriate regulatory mechanism in the event and an outbreak occurs before fda approval is received (centers for disease control and prevention b; henao-restrepo et al. ) . another ebola vaccine candidate, the recombinant adenovirus type- ebola vaccine, was evaluated in a phase trial in sierra leone in . an immune response was stimulated by this vaccine within days of vaccination and strict contact precautions (hand hygiene, double gloves, gowns, shoe and leg coverings, and face shield or goggles) and droplet precautions (private room or cohorting, surgical mask within ft) are mandatory for viral hemorrhagic fevers. airborne precautions (negative-pressure isolation room with - air exchanges per h) should also be instituted to the maximum extent possible and especially for procedures that induce aerosols (e.g., bronchoscopy). at a minimum, a fit-tested, hepa filter-equipped respirator (e.g., an n- mask) should be used, but a battery-powered papr or a positive pressure-supplied air respirator should be considered for personnel sharing an enclosed space with, or coming within ft of, the patient. multiple patients should be cohorted in a separate ward or building with a dedicated airhandling system when feasible (table . ). environmental decontamination is accomplished with hypochlorite or phenolic disinfectants (beigel and sandrock ; radoshitzky et al. ; usamriid ; won and carbone ) . francisella tularensis, a small aerobic, nonmotile gram-negative coccobacillus, causes tularemia (rabbit fever). clinical disease is caused by two isolates, biovars jellison type a and b. this organism can be stabilized for weaponization and delivered in a wet or dry form. the incubation period is usually - days (range - days). initial symptoms are nonspecific and mimic the flu-like symptoms or other upper respiratory tract infections. there is acute onset of fever with chills, myalgias, cough, fatigue, and sore throat. the two clinical forms of tularemia are typhoidal and ulceroglandular diseases. typhoidal tularemia ( - %) occurs after inhalational exposure and sometimes intradermal or gastrointestinal exposures. there is abrupt onset of fever, headache, malaise, myalgias, and prostration. it presents without lymphadenopathy. nausea, vomiting, and abdominal pain are sometimes present. untreated, there is a % mortality rate in naturally acquired cases (vs. - % in those treated). it is higher if pneumonia is present. this form would be most likely seen during an aerosol release of the agent. ulceroglandular tularemia ( - %) occurs through skin or mucus membrane inoculation. there is abrupt onset of fever, chills, headache, cough, and myalgias along with a painful papule at the site of exposure. the papule becomes a painful ulcer with tender regional lymph nodes. skin ulcers have heaped up edges. in - %, there is focal lymphadenopathy without an apparent ulcer. lymph nodes may become fluctuant and drain when receiving antibiotics. without treatment, they may persist for months or even years. in some cases ( - %), the primary entry port is the eye leading to oculoglandular tularemia. patients have unilateral, painful, and purulent conjunctivitis with local lymphadenopathy. chemosis, periorbital edema, and small nodular granulomatous lesions or ulceration may be found. oropharyngeal tularemia with pharyngitis may occur in % of patients. findings include exudative pharyngitis/tonsillitis, ulceration, and painful cervical lymphadenopathy. the differential diagnosis is antibiotic unresponsive pharyngitis, infectious mononucleosis, and viral pharyngitis. pulmonary involvement ( - %) is seen in naturally occurring disease. it ranges from mild to fulminant. various processes include pneumonia, bronchiolitis, cavitary lesions, bronchopleural fistulas, and chronic granulomatous diseases. left untreated, % will die. differential diagnoses include those for typhoidal (typhoid fever, rickettsia, and malaria) or pneumonic (plague, mycoplasma, influenza, q-fever, and staphylococcal enterotoxin b) tularemia. diagnosis should be considered when there is a cluster of nonspecific, febrile, systemically ill patients who rapidly progress to fulminant pneumonitis. tularemia can be diagnosed by recovering the organism from sputum (pcr or dfa) or serology at a state health laboratory. chest radiograph is nonspecific with possible hilar adenopathy. treatment is streptomycin or gentamicin (table . ). alternatives include doxycycline, ciprofloxacin, or chloramphenicol. a live-attenuated vaccine (ndbr ) exists and typically used for laboratory personnel working with francisella tularensis. there is no passive immunoprophylaxis. ciprofloxacin or doxycycline can be given as pre-and postexposure prophylaxis (beigel and sandrock ; hepburn et al. ; pittman et al. ; usamriid ) . botulinum neurotoxins (bont) are produced from the spore-forming, gram-positive, obligate anaerobe clostridium botulinum. it is the most potent toxin known to man. a lethal dose is ng per kilogram. it is , times more toxic than sarin (gb). there are seven serotypes of botulinum toxin (a through g). a new serotype (h) has been tentatively identified in a case of infant botulism but has not been fully investigated. most common are serotypes a, b, and e. the toxin acts on the presynaptic nerve terminal of the neuromuscular junction and cholinergic autonomic synapses. this disrupts neurotransmission and leads to clinical findings. there are three forms of botulism: foodborne, wound, and intestinal (infant or adult intestinal). botulinum toxin can also be released as an act of bioterrorism via ingestion or aerosol forms. incubation can be from h after exposure to several days later. clinical findings of botulism include cranial nerve palsies such as ptosis, diplopia, and dysphagia. this is followed by symmetric descending flaccid paralysis. however, the victim remains afebrile, alert, and oriented. death is typically due to respiratory failure. prolonged respiratory support is often required ( - months). differential diagnoses include guillain-barre syndrome, myasthenia gravis, tick paralysis, stroke, other intoxications (nerve gas, organophosphates), inflammatory myopathy, congenital and hereditary myopathies, and hypothyroidism. diagnosis is mostly clinical. laboratory confirmation can be obtained by bioassay of patient's serum. other assays include immunoassays for bacterial antigen, pcr for bacterial dna, and reverse transcriptase-pcr for mrna to detect active synthesis of toxin. cerebrospinal fluid demonstrates normal protein (unlike guillain-barre syndrome). emg reveals augmentation of muscle action potential with repetitive nerve stimulation at - hz. treatment (table . ) is mainly supportive including intubation and ventilator support. tracheostomy may be required due to prolonged respiratory weakness and failure. antibiotics do not play a role in treatment. botulism antitoxin heptavalent [a, b, c, d, e, f, g]-equine (bat) was approved by the fda in . bat was developed at usamriid as one of two equine-derived heptavalent bont antitoxins. bat is approved to treat individuals with symptoms of botulism following a known or suspected exposure. it has the potential to cause hypersensitivity reactions in those sensitive to equine proteins. the safety of bat in pregnant and lactating women is unknown. evidence regarding safety and efficacy in the pediatric population is limited. in , the fda approved botulinum immune globulin intravenous (babybig), a human botulism immune globulin derived from pooled plasma of adults immunized with pentavalent botulinum toxoid. it is indicated for the treatment of infants with botulism from toxin serotypes a and b. immediately after clinical diagnosis of botulism, adults (including pregnant women) and children should receive a single intravenous infusion of antitoxin (bat or, for infants with botulism from serotypes a or b, babybig) to prevent further disease progression. the administration of antitoxin should not be delayed for laboratory testing to confirm the diagnosis. the pentavalent toxoid vaccine (previously for protection against a, b, c, d, and e; but not f or g) is no longer available as of . no replacement vaccine is currently available. standard isolation precautions (table . ) should be followed (beigel and sandrock ; dembek et al. ; pittman et al. ; timmons and carbone ; usamriid ). ricin is a potent cytotoxin derived from the castor bean plant ricinus communis. it is related in structure and function to shiga toxins and shiga-like toxin of shigella dysenteriae and escherichia coli, respectively. it consists of two glycoprotein subunits, a and b, connected by a disulfide bond. the b-chain allows the toxin to bind to cell receptors and gain entrance into the cell. once ricin enters the cell, the disulfide chemical linkage is broken. the free a chain then acts as an enzyme and inactivates ribosomes thereby disrupting normal cell function. cells are incapable of survival and soon die. ricin has a high terrorist potential due to it characteristics: readily available, ease of extraction, and notoriety (maman and yehezkelli ) . three modes of exposure exist: oral, inhalation, and injection. four to eight hours after inhalation exposure, the victim develops fever, chest tightness, cough, dyspnea, nausea, and arthralgias. airway necrosis and pulmonary capillary leak ensues within - h. this is followed quickly by severe respiratory distress, ards, and death due to hypoxemia within - h. injection may cause minimal pulmonary vascular leak. pain at the site and local lymphadenopathy may occur. however, it may be followed by nausea, vomiting, and gastrointestinal hemorrhage. ingestion leads to necrosis of the gastrointestinal mucosa, hemorrhage, and organ necrosis (spleen, liver, and kidney). diagnosis is suspected when multiple cases of acute lung injury occur in a geographic cluster. serum and respiratory secretions can be checked for antigen using elisa. pulmonary intoxication is managed by mechanical ventilation. gastrointestinal toxicity is managed by gastric lavage and use of cathartics. activated charcoal has little value due to the size of ricin molecules. supportive care is indicated for injection exposure. in general, treatment is largely supportive, especially for pulmonary edema that can result from the capillary leak. there is no vaccine available or prophylactic antitoxin for human use. however, there are two ricin vaccines in the development that focus on the ricin toxin a (rta) chain subunit. a mutant recombinant rta chain vaccine, rivax, has been shown to be safe and immunogenic in humans. the other vaccine is another recombinant rta chain vaccine, rvec . it has shown effectiveness in animal models by producing protective immunity against aerosol challenge with ricin in animal models. standard precautions are advised for health care workers (pittman et al. ; roxas-duncan et al. ; traub ; usamriid ). recent events which include the nuclear reactor meltdown at fukushima and international tension between nuclear powers, spark concern over potential devastation from nuclear catastrophes. there are numerous examples of radiation disasters in history. sixty-six thousand people were killed in hiroshima and thirty-nine thousand people were killed in nagasaki from nuclear bombs detonated over these cities in (avalon project-documents in law, history and diplomacy n.d.). many other people suffered from long-term consequences of radiation poisoning. in , , square kilometers of land in russia, ukraine, and belarus were contaminated with radiation from a meltdown at a nuclear power plant in chernobyl, ukraine. one hundred and thirty-five thousand people were permanently evacuated from their homes (likhtarev et al. ) . long-term health consequences included many children who developed thyroid cancer several years later. many of these children died. a tsunami pummeled the east coast of japan in march of . the power outage that ensued at the fukushima power plant led to a failure of the cooling system of the fuel rods, leading to a meltdown of four of the reactors at the plant. a massive quantity of radiation was released into the atmosphere, forcing people to evacuate their homes indefinitely. creative thinking and heroic actions by the tokyo fire department prevented entire populations of cities from being poisoned with radiation. terrorism experts are concerned that terrorist organizations will produce and detonate a radiological dispersion device (rdd), sometimes referred to as a dirty bomb. this is a conventional explosive, loaded with radioactive material which would be dispersed upon detonation. this would likely involve only one radioisotope. fewer people would be exposed and a smaller area would be contaminated than what would transpire with the detonation of a nuclear weapon. spreading fear and panic would be the primary purpose of such a device (mettler jr and voelz ) . radiation is the emission and propagation of energy through space or through a medium in the form of waves. radiation can be ionizing or nonionizing depending on the amount of energy released. most radiation that people encounter is low energy and, therefore, nonionizing with no biological effects. ionizing radiation emits enough energy to strip electrons from an atom, which provokes cellular changes and thereby, results in biological effects. radiation emitted from nuclear decay is always ionizing (radiation emergency assistance center/training site (react/s-cdc) ). atomic nuclei are held together by a very powerful binding energy despite positively charged protons repelling each other. this energy is released from unstable nuclei in the form of electromagnetic waves or particles. when ionizing radiation reaches biological tissue, chemical bonds are disrupted, free radicals are produced, and dna is broken. electromagnetic waves are of two types, x-rays and gamma rays. x-rays are relatively low energy and less penetrating. gamma rays have a shorter wavelength and contain relatively higher energy, making them more penetrating of biological tissue. ionizing radiation in the form of particles consists of alpha particles, beta particles, and neutrons. alpha particles are the largest of the forms of particulate radiation. they are composed of two neutrons and two protons. they do not easily penetrate solid surfaces, including clothes and skin. however, they can cause severe damage to an organism if internalized. in , in the united kingdom, alexander litvienko, an ex kgb agent was poisoned with a radioactive element called polonium (mcphee and leikin ). a small amount of polonium was sprinkled into his food. polonium releases alpha particles when it decays. it was relatively safe for the assassin to carry this element with him because of the relatively poor ability of alpha particles to penetrate clothing and skin. once it is ingested, however, alpha particles have profound biological effects. mr. litvienko became very ill, and ultimately died. beta particles are high energy electrons discharged from the nucleus and are highly penetrating. neutrons emitted from a nucleus are also highly penetrating. in general, neutrons are only released by the detonation of a nuclear weapon. ionizing radiation of any form cannot be detected by our senses. it is not smelled, felt by touch, tasted, or seen. it is possible to be exposed to a lethal dose of radiation without realizing it. in goiania, brazil, in , children found a canister of radioactive cesium ( cs) that had been looted from a medical center and left in the street. the children liked the appearance of the substance but were not able to sense any abnormalities or danger with it. they began to rub it on their bodies because they liked the way it made them glow in the dark. the children all became ill. ultimately, people were exposed to this radioisotope. it took days before physicians recognized that the people had radiation poisoning. four people died of acute radiation syndrome. four factors determine the severity of exposure to ionizing radiation: time, distance, dose, and shielding. time is the time of exposure to the radiation source. distance is the distance from the radiation source. based on the inverse square law, exposure is reduced exponentially with increasing distance from the radiation source. dose is measured by the amount of energy released by the source and is numerically described by how many disintegrations per second occur, in curies (ci) or becquerels (bq). shielding is the efficacy of the barrier to the radioactive source. lead is well-known to be a very effective shield to x-rays. in a radiation exposure, injury to skin from trauma or burns may cause a greater degree of contamination because of loss of the shielding of the skin. there are four important principles for the nurse or hcp to understand with regard to exposure to ionizing radiation: external exposure, external contamination, internal contamination, and incorporation. external contamination occurs when radioactive material is carried on a person after exposure. this person can then contaminate others. removing contaminated clothing eliminates % of the toxin. others are then less vulnerable to exposure. internal contamination is when a radioactive substance enters the body through inhalation, ingestion, or translocation through open skin. incorporation is internalization of the toxin into body organs. incorporation is dependent on the chemical and not the radiological properties of the radioactive toxin. radioactive iodine, i, is taken up by the thyroid gland because iodine enters the gland as part of normal physiology (advanced hazmat life support (ahls) ). ionizing radiation can damage chromosomes directly and indirectly, causing ravaging biological effects. indirect damage comes from the production of h + and oh − . free radical formation upsets biochemical processes and causes inflammation. these effects can take anywhere from seconds to hours to be expressed. clinical changes can take from hours to years to be realized (zajtchuk et al. ). immediately after a major radiation exposure, the clinical matters of most concern are those related to trauma from blast and thermal injuries. these injuries may be life-threatening and must be addressed first. after thermal and traumatic injuries are addressed, attention should be paid to the severity of radiation exposure. severe exposure can cause acute radiation syndrome. "the acute radiation syndrome is a broad term used to describe a range of signs and symptoms that reflect severe damage to specific organ systems and that can lead to death within hours or up to several months after exposure" (national council on radiation protection (ncrp) and measurements ; national council on radiation protection (ncrp) and measurements ). the mechanism of cell death from toxic radiation exposure is related to the inhibition of mitosis. organs with the most rapidly dividing cells are the most susceptible. the gastrointestinal and the hematopoietic are the organ systems most notably affected. the organs of pediatric patient have a higher mitotic index, in general, to those of adults and are more vulnerable to injury from radiation poisoning. the time of onset and the severity of acute radiation syndrome are controlled by the total radiation dose, the dose rate, percent of total body exposed, and associated thermal and traumatic injuries. there is a % death rate (ld ) within days for people exposed to a dose of radiation of . - . gy. the ld is lower for the pediatric population. the acute radiation syndrome is composed of four phases: prodromal, latent, manifest illness, and death or recovery. inflammatory mediator release during the prodromal phase causes damage to cell membranes. this phase occurs during the first h after exposure to radiation. nausea and vomiting and fever can occur during this time. if these symptoms occur during the first h after exposure, there is a poor prognosis. the onset of the latent phase is usually in the first days post exposure but can ensue anytime during the first days thereafter. all cell lines of the hematopoietic system are affected. lymphocytes and platelets, the most rapidly dividing cells of the bone marrow, are most severely affected. the illness phase manifests after days since radiation exposure. infection, impaired wound healing, anemia, and bleeding occur during this time of illness. the hematopoietic, gastrointestinal, central nervous, and integumentary are the organ systems affected. there is a marked reduction of cells from all cell lines of the bone marrow. there is a direct correlation with the drop in absolute lymphocyte count with the dose of radiation received. the absolute lymphocyte count is commonly used to estimate the dose of radiation received. the gastrointestinal (gi) epithelial lining, one of the most rapidly dividing cell lines of the body is the second most vulnerable to radiation poisoning. the radiation dose required to affect the gi system is gy. vomiting, diarrhea, and a capillary leak syndrome for gi tract are common manifestations. hypovolemia and electrolyte instability ensue. translocation of bacteria into the bloodstream, combined with the diminished immunity caused by the decimation of the hematopoietic system, place victims at high risk for septic shock. another organ system affected by the acute radiation syndrome is the central nervous system. this requires a large dose of at least gy. manifestations include cerebral edema, disorientation, hyperthermia, seizures, and coma. acute radiation syndrome that involves the central nervous system is always fatal. the integumentary system is frequently affected by the acute radiation syndrome, especially if the skin is in direct contact with a radioisotope. epilation, erythema, dry desquamation, wet desquamation, and necrosis occur respectively with increasing severity associated with increasing doses of radiation. radiation burns can be distinguished from thermal or chemical burns by their delayed onset. it can take days to weeks for radiation burns to affect victims. thermal and chemical burns cause signs and symptoms more acutely. hospitals that anticipate victims of radiation should prepare areas of triage with decontamination supplies and techniques ready to be deployed. an emergency department (ed) should be divided into "clean" and "dirty" areas. the dirty area is created for the purpose of decontamination to prevent the spread of radioisotopes. all health care personnel should wear ppe including surgical scrubs and gowns, face shields, shoe covers, caps, and two pairs of gloves. the inner pair of gloves is taped to the sleeves of the gown. each health care worker should be monitored for the exposure of the radiation and its dose with a dosimeter worn underneath the gown. the radiation safety officer of the hospital should take a leadership role in health care worker protection and decontamination procedures. consultation from the radiation emergency, assistance center (react/ts) is imperative. react/ts is a subsidiary of the u.s. department of energy. its contact information is as follows: phone number during business hours is - - . the phone number is - - after business hours. the react/ts website is http://orise.orau. gov/reac/ts/. as victims arrive, triage protocols of mass casualty scenarios should be implemented. it should be noted that radiation exposure is not "immediately" lifethreatening. initial clinical management should focus on the abcde (airway, breathing, circulation, disability, and exposure) of basic trauma protocol. the "d" in the above acronym can also be a symbol for decontamination. after airway, breathing, and circulation are addressed, initial phase of decontamination entails careful removal of potentially contaminated clothing. caution should be exercised to remove the clothing gently, while rolling garments outward to prevent the release of dust of radioactive material that could contaminate people in the treatment area. further decontamination procedures take place after initial stabilization. skin decontamination procedures are identical to those of toxic chemical exposure with the following exceptions: • ppe are slightly different as described above. • gentle skin rubbing is done to prevent provocation of an inflammatory response and further absorption of the radioactive toxin. • only soap and water are used. rubbing alcohol and bleach should be avoided. it is advisable to shampoo the hair first, because it is usually the site of the highest level of contamination of the body, and runoff onto the body can then be cleansed during skin decontamination (radiation event medical management (remm) of the u.s. dept. of health and human services n.d.). it should be noted that health care workers are not at risk for contamination if they wear proper ppe during the resuscitation and decontamination process. the lack of knowledge of this point may lead to reluctance to treat patients and increase morbidity and mortality for victims. "no hcp has ever received a significant dose of radiation from handling, treating, and managing patients with radiation injuries and/or contamination."(react/s-cdc ). when initial resuscitation and decontamination have been completed, attention should be paid to ongoing support of ventilation, oxygenation, the management of fluid and electrolytes, and treatment of traumatic and burn injuries. infection control procedures are important due to the impending immunocompromised state of the victims. it is important to ascertain the details of the catastrophic event. data on the nature and size of the exposure and the types of radioactive agents involved are vital for ongoing management and decontamination. after the details of the nature of the exposure are uncovered, diagnostic tests should be done, including serial cbc and cytogenetic analysis of lymphocytes, otherwise known as cytogenic dosimetry (react/s-cdc ). measurements of change in lymphocyte counts and cytogenetic dosimetry are sensitive markers for the dose of radiation received by a victim. measurements of internal decontamination are done by the sampling and analysis of nasal and throat swabs, stool, and h urine. wound samples and irrigation fluid should also be sampled. after initial stabilization, external decontamination, and diagnostic testing, internal decontamination is performed. external decontamination involves removal of clothes and cleaning the skin and hair. internal decontamination removes radioisotopes that are internalized via inhalation, ingestion, and entry into open wounds. because ionizing radiation is being released inside the body, internal decontamination must be performed promptly after initial resuscitation. since radioisotopes behave identically to their nonradioactive counterparts, antidotes are chosen based on the chemical, and not the radiological properties of the element. basic strategies of internal decontamination include chelation, competitive inhibition, enhanced gastrointestinal elimination, and enhanced renal elimination. specific agents are used for chelation of different radioisotopes. dtpa (diethyenetriaminepentaacetic acid) is administered for the elimination of heavy metals such as americium, californium, curium, and plutonium. dtpa comes in two forms, calcium dtpa (ca-dtpa) and zinc-dtpa (zn-dtpa). ca-dtpa is ten times more effective than zn-dtpa. for adults and adolescents, administration is as follows: • g of ca-dtpa iv initially in the first h, followed by g zn-dtpa iv daily for maintenance. • for children less than years of age administer: • fourteen mg/kg ca-dtpa iv initially, followed by fourteen mg/kg of zn-dtpa iv daily thereafter (national council on radiation protection (ncrp) and measurements ). • the initial dose of dtpa may be administered via inhalation to adolescents and adults if the contamination occurred via inhalation. this method of administration is not approved for pediatric use. chelation with dimercaprol (bal) is used to eliminate polonium. bal is a highly toxic drug and should be administered with caution. the dose is . mg per kg im four times a day for days, then twice a day on the third day and once a day for - days, thereafter (national council on radiation protection (ncrp) and measurements ). alkalinization of the urine is renal protective during administration. a less toxic alternative to bal, dimercaptosuccinic acid (dmsa), otherwise known as chemet ® is also available. the dose of dmsa is ten mg per kg po every h for days. the same dose is given every h for days, thereafter (national council on radiation protection (ncrp) and measurements ). another mechanism for internal decontamination is competitive inhibition. the radioisotope, i, is released during a meltdown of a reactor at a nuclear power plant. potassium iodide (ki) is widely recognized as a competitive inhibitor to its radioactive counterpart, i, from being incorporated into the thyroid gland. ki blocks % of i uptake into the thyroid gland if ki is given within the first hour of exposure. it will block % of incorporation if given within h of exposure. its protective effect lasts for h. with administration of this drug, thyroid function should be monitored closely. dosing guidelines (table . ) are included in the table below (u.s. food and drug administration n.d.). gastrointestinal elimination is another mechanism of internal decontamination (table . ). an ion exchanger, prussian blue, (ferric ferrocyanide), binds elements that circulate through the enterohepatic cycle. since it is not absorbed through the gastrointestinal tract, prussian blue carries the toxins into the stool. it is highly effective in the elimination of cs or thallium and was used during the cs incident in goiania, brazil. the dosing of prussian blue is as follows: • infants: . - . mg per kg po three times a day (not fda approved). • children - years of age: g po three times a day. • children ≥ years of age: g po three times a day. • prussian blue is administered for at least days, and can be adjusted based on the degree of poisoning (national council on radiation protection (ncrp) and measurements ). urinary elimination is another useful method of internal decontamination. tritium can be eliminated with excess fluid administration. uranium is eliminated by alkalinizing the urine to a ph of - . sodium bicarbonate is given at a dose of meq/kg iv every - h and is titrated to effect. if renal injury occurs, dialysis may be required. the basic approach to treating acute radiation syndrome is supportive therapy. gi losses from gastrointestinal difficulties are treated with iv fluids and electrolyte replacement. -ht antagonists can be used to suppress vomiting and benzodiazepines for anxiety. a patient suffering from acute radiation syndrome may be severely immunocompromised and requires a room with positive pressure isolation. colony stimulating agents for granulocytes and erythrocytes can be used for bone anemia and leukopenia. bone marrow transplant may be required for severe cases. a patient with skin contamination with radiation should be decontaminated with soap and water. a geiger counter can be helpful to identify areas of contamination. scrubbing is performed in a concentric matter, beginning at the outer layers of contamination and moving into the center since the area of greatest contamination is in the center. in this way, the area of contamination remains contained. attention should be paid to good nutrition and pain control. burn and plastic surgery service should also be consulted. more details on decontamination can be found in chap. . the psychological impact of a radiation catastrophe on the pediatric victims is likely to be devastating (american academy of pediatrics (aap) ). sleep disturbances, social withdrawal, altered play, chronic fear and anxiety, and developmental regression can occur. a correlation between the parent's psychological response and that of the child would occur as with other types of disaster. mental health professionals should be consulted in the event of this type of situation. please refer to chap. for more information. a lot of concern has been expressed over the possibility of terrorist attacks involving explosive devices in recent years (depalma et al. ) . explosive devices are relatively simple to manufacture and easy to detonate. they can injure and kill many people and spread fear over large populations. victims of bomb blasts sustain more body regions injured, have more body injury severity scores, and require more surgeries than victims of nonexplosive trauma incidents. victims of explosives also have a higher mortality (kluger et al. ) . these observations are also true of pediatric victims (daniel-aharonson et al. ) . many factors influence the number of people injured and the severity of the injuries in an explosion. the magnitude of the explosion and its proximity to people and the number of people in the area affect the severity and number of injuries. other factors include the collapse of building or structure from the blast, promptness of the rescue operation, and the caliber and proximity of medical resources in the vicinity. victims who experience explosions in closed spaces are especially vulnerable to more severe injuries. twenty-nine case reports of injuries from terrorist bombings were reviewed (arnold et al. a) . the investigators compared the injury severity of victims of explosions who sustained injuries from structural collapse, closed space explosions without structural collapse, and open space explosions. the mortality rate for these victims was %, %, and %, respectively. hospitalization rates were %, %, and %, respectively. ed visits were %, %, and %, respectively. victims of closed space explosions without structural collapse experienced greater hospitalizations rates than those involved in a structural collapse, because many of the victims involved in the structural collapse experienced immediate death. an explosion is defined as a rapid chemical conversion of a liquid or solid into a gas with energy release. substances that are chemically predisposed to explosion, called explosives, are characterized as low or high order, depending on the speed and magnitude of energy release. low-order explosives release energy at a relatively slow pace and explosions from these substances tend not to produce large air pressure changes or a "blast." the energy release is caused by combustion, producing heat. the involved material "goes up in flames." gunpowder, liquid fuel, and molotov cocktails are examples of low-order explosives (centers for disease control and prevention ). explosions from high-order materials cause a blast with a pressure wave in addition to causing the release of heat and light. the blast pressure wave causes compression of the surrounding medium which is physically transformed in all directions from the exact point of explosion. when an explosion occurs on land, air is the surrounding medium compressed. in bodies of water, the surrounding medium is water. the degree of medium compression and the distance that the energy wave travels is determined by the magnitude of the explosion. the power of the blast is measured in pounds per square inch (psi). the pressure blast wave has distinctive characteristics. the amplitude of the wave reaches its highest point immediately after the blast. the blast wave then rapidly decays as it travels through space. as the blast wave propagates, and compresses the surrounding medium, it leaves a vacuum because of displaced molecules in the surrounding medium and a negative phase of the wave ensues. in a land explosion, air molecules are displaced by the initial positive pressure, after which a negative pressure occurs in the vacated space. a wave that propagates through a confined space rebounds off of the wall and reverberates. it may interact with victims in the confined space many times, causing more severe injuries (stuhmiller et al. ) (fig. . ). four kinds of injury occur in high energy explosions. primary blast injuries occur directly from the pressure wave of the blast. secondary injuries occur from being struck by flying objects from the blast. these injuries can be blunt or penetrating. tertiary injuries occur when victims are displaced from a location and strike other objects or surfaces. all other injuries related to the blast are called quarternary. they include burns, inhalational injuries, toxic exposures, and traumatic injuries from structural collapse. primary injuries from blast waves affect bodily tissues with a tissue gas interface. when a pressure wave enters the body, tissue of gas filled organs compress slower than the air inside the tissue, causing stress in the tissue, possibly damaging it. this baseline positive phase originally described by friedlander, a blast wave consists of a short, high-amplitude overpressure peak followed by a longer depression phase. injury potential depends on the wave's amplitude as well as the slopes of its increase and decrease in pressure. x-axis refers to time and y-axis refers to pressure. (jacobson and severin ) also known as the "spalling effect." as the negative pressure phase of the blast wave propagates through, it causes more stress on the tissue and further damage. in addition to damaging tissues with an air tissue interface, pressure blasts can cause injury to the brain and can lead to limb detachments. despite the fact that primary blast injuries can be ravaging, they are less common than other types of injury from blasts. the tympanic membranes, lungs, and gastrointestinal tract are the most common organs sustaining injury from pressure waves. the tympanic membrane is the most vulnerable of these three organ systems (depalma et al. ; garth ) . five psi, which is considered a weak blast, will rupture % of tympanic membranes. to put this in perspective, c , a commonly used explosive generates a pressure of four million psi. otoscopy can reveal ruptured tympanic membranes. neuropraxia, deafness, tinnitus, and vertigo are symptoms that can be experienced. severe blast injuries of the ear can result in damage to the organ of corti, resulting in permanent hearing loss. the second most common organ injured from a blast wave is the lung. fifteen psi are required to cause injury to this organ. lung injuries are more likely to occur from a blast within a closed space, or when victims sustain burns (burns commonly cause acute lung injury from release of inflammatory mediators). direct alveolar damage, blood vessel with bleeding, and inflammation are the three different manifestations of lung injury from blasts. alveolar damage can cause pneumothorax and pulmonary interstitial emphysema. when air dissects along the bronchovascular sheath, pneumomediastinum, pneumopericardium, and subcutaneous emphysema can occur. air that enters the pulmonary venous system can result in a systemic arterial air embolism, and possibly, a stroke. inflammation of the lungs from direct pressure damage to the tissue, cause acute lung injury and possibly, disseminated intravascular coagulation. clinical signs of lung injury include tachypnea, chest pain, hypoxia, rales, and dyspnea. if there is vascular disruption, hemoptysis can occur. air leaks from alveolar injury can result in diminished breath sounds, subcutaneous crepitance, increased resonance, and tracheal deviation. hemodynamic compromise will occur with tracheal deviation. alveolar damage, leading to air in the pulmonary venous system, can lead to a systemic arterial air embolism. air in the coronary arteries can lead to coronary ischemia with st and/or t waves changes on ecg. air embolism to cerebral arteries leads to cerebral vascular accidents (strokes) with focal neurological deficits. other manifestations of systemic air embolism include mottling of the skin, demarcated tongue blanching, and/or air in the retinal vessels (the most common sign of arterial air embolus). rapid death after initial survival is most often caused by arterial air embolus. initiation of positive pressure ventilation may trigger this event (ho and ling ) . a lung injury from a blast can also precipitate a vagal reflex resulting in bradycardia and hypotension. it is postulated that this occurs from the stimulation of c fibers in the lungs (guy et al. ). the gastrointestinal system is the third most common organ system affected by primary blast injury. physical stress and/or mesenteric infarct leads to weakening of the bowel wall with possible rupture. hemorrhage can also occur (paran et al. ; sharpnack et al. ) . the most common site of injury is the colon. injury to the bowel can be delayed and occur up to several days after the inciting incident. solid organs are spared because of their homogeneity and lack of air tissue interface. brain injury is becoming increasingly recognized as a result of primary blast. shearing injuries of the brain occur as a result of wave reverberation in the skull. hippocampal injury causing cognitive impairment has been shown in animal studies (cernak ; cernak et al. ; singer et al. ) . observations in humans have revealed electroencephalographic abnormalities and attention deficit disorder (born ) . human autopsies have revealed punctate hemorrhages and disintegration of nissl substance in victims who sustained blast injury without direct head trauma (guy et al. ) . research involving yucatan minipigs revealed that the brain sustains neuronal loss in the hippocampus after being subjected to primary blast injury. brain injury also occurred from the inflammation that ensued post blast (goodrich et al. ) . novel therapeutic approaches may be on the horizon for treatment of traumatic brain injury, including that caused by primary blast. intranasal insulin administered to rats subjected to traumatic brain injury resulted in enhanced neuronal glucose uptake and utilization, and subsequently improved motor function and memory. decreased neuroinflammation and preservation of the hippocampus were also noted (brabazon et al. ) . in a different investigation, a neuroprotective nucleotide, guanosine, was administered to rats subjected to traumatic brain injury. the treatment group of rats had better locomotor and cognitive outcomes than did the placebo group. programmed cell death and inflammation were also attenuated in the treatment group (gerbatin et al. ) . the leading cause of death from blast is from flying objects striking victims (secondary blast injury). eyes are particularly vulnerable. injuries resulting from displacement of the victims who strike objects are known as tertiary injuries. lighter weight children are particularly susceptible to this type of injury. burns, toxic exposures, and crush injuries constitute quaternary injuries. crush injuries commonly occur in explosions with structural collapse. the "crush syndrome" can occur when a trapped limb sustains prolonged compromise to the circulation, leading to rhabdomyolysis. tissue destruction and inflammatory response then occur. lifethreatening electrolyte abnormalities including hyperkalemia, renal failure, hyperuricemia, metabolic acidosis, acute respiratory distress syndrome, disseminated intravascular coagulation, and shock can result from crush syndrome (gonzalez ) . the crush syndrome is commonly seen in natural disasters that result in a lot of structural collapse. structural collapse and fires can cause the release of toxic materials such as carbon monoxide and cyanide. knowledge of the details of a blast can greatly enhance the ability of nurses and hcps to care for victims of a blast in a hospital setting. knowledge of whether a blast occurred in a closed or open space, whether structural collapse occurred, or if a victim was rescued from a collapsed area are details that can alert nurses and hcps as to what kind of injuries that they may anticipate. if toxic substances are released with a blast, nurses and hcps can prepare for decontamination techniques and antidote therapies. it would be advantageous for a hospital to be aware of the number of victims that are arriving for care. a mass casualty incident will stress the resources of the institution. hospital personnel should take stock of the resources that are available. the number of available ventilators and o-blood are examples of finite resources that should be considered. advanced trauma life support (atls) principles should be applied to all blast injury victims. abcd of initial resuscitation is applied. the "d" stands for disability as well as decontamination. decontamination techniques should be deployed if there is uncertainty about toxic exposure as described elsewhere in this chapter. on completion of abcd of initial resuscitation a secondary survey is performed, as described by atls protocol. attention should be paid to potential injuries that occur with blast injuries. ruptured tympanic membranes should alert the nurse or hcp of problems from primary blast injury. impaled objects should remain in place and removed in the operating room by surgical staff so that bleeding may be controlled. a thoracoscopy tube should be placed with an open three point seal over a wound on the side of the chest with an open pneumothorax. a hemothorax is also treated with a thoracoscopy tube. an autotransfusion setup can be applied to recirculate the blood from the pleural cavity of a hemothorax (wightman and gladish ) that would help preserve donor blood for other victims. for severe respiratory distress and/or impending respiratory failure, endotracheal intubation should be performed and positive pressure ventilation should be instituted. because lung tissue could be weakened from primary blast injury, caution should be exercised because of a high risk of pneumothorax, hemorrhage, or arterial air embolus. gentle application of positive pressure ventilation should be applied to avoid these complications. if only one lung is injured unilateral lung ventilation can be considered for larger children and adults. this technique is not suitable for babies and small children. supplemental oxygen with an fio of % should be administered to patients suspected of having an arterial air embolus. hyperbaric oxygen therapy could even be considered to help accelerate the removal of air from the arteries. placement of the patient in the left lateral recumbent position may reduce the likelihood of the air lodging in the coronary arteries. victims of blast injuries should be treated identically to those of other types of trauma after initial resuscitation is completed. if primary blast injury occurred, frequent chest and abdominal x-rays should be performed in consideration of the possibility of lung or gastrointestinal injuries. limbs with open fractures should be immobilized and covered with sterile dressings. systemic, broad spectrum antibiotics should be administered to patients with open limb injuries. eyes that sustained chemical injury should be irrigated with water for an hour. all injured eyes should be covered. most ruptured tympanic membranes will heal spontaneously. victims with tympanic membrane injury should be advised to avoid swimming for some time. topical antibiotics are prescribed if dirt or debris is seen in the ear canal. oral prednisone is prescribed for hearing loss. victims with crush injuries should be treated with large volumes of iv fluids to treat inflammatory shock and possibly rhabdomyolysis. electrolytes should be monitored carefully as these patients are at risk for hyperkalemia, hyperphosphatemia, hyperuricemia, hypocalcemia, and acidosis. smoke inhalation, burns, and toxic exposures should be treated according to guidelines of burn, trauma, and toxicology protocols. mass casualty incidents (i.e. mass shootings, active shooter events, bombings, and other multifatality crimes) often attract extensive media coverage as well as the attention of policy makers. many agencies and organizations record and publish data on these incidents. the measurement and reporting does vary based on the absence of a common definition. however, it is clearly evident that mass casualty incidents (mcis) continue to increase in both number and scope (federal bureau of investigation ; office for victims of crime, office of justice programs, u.s. department of justice ). in the u.s., mass shootings are the most common and most closely tracked. the congressional research service (crs) defines mass shootings as events where more than four people are killed with a firearm "within one event, and in one or more locations in close proximity." congress uses the term mass killings and describes these events as "three or more killings in a single incident." the federal bureau of investigation (fbi) uses the term active shooter, which it defines as "an individual actively engaged in killing or attempting to kill people in a populated area." it is important to realize that nongovernmental ( ranking third of all locations for and , seven of the incidents occurred in educational environments resulting in five killed and wounded. two incidents occurred in elementary schools, resulting in two killed (including a firstgrade student) and eight wounded (one teacher shot, three students shot, and four wounded from shrapnel). one incident occurred in a junior/senior high school, resulting in none killed and four wounded (two from shrapnel, all students). four incidents occurred at high schools (one outside a school during prom), resulting in three killed (all students) and seven wounded (all students). fortunately, no incident occurred at institutions of higher learning during or (advanced law enforcement rapid response training (alerrt) center, texas state university and federal bureau of investigation, u.s. department of justice ). notably, two of the incidents occurred in houses of worship, resulting in killed and wounded. one of these incidents occurred at the first baptist church in sutherland springs, texas, and had the third highest number of casualties ( killed and wounded) in . the dead included women, men, children ( girls and boy), and an unborn child (goldman et al. ) . a summary report has also been developed for all active shooter incidents from to , including incidents per year (fig. . ), casualties per year (fig. . ) , and location ( fig. . ) categories (federal bureau of investigation ; federal bureau of investigation ). overall, there was an increase in number of active shooter incidents and casualties per year. location categories with number of incidents and statistics of their contribution were provided: areas of educational environments account for a large portion of locations for active shooter incidents, ranking only second to commercial areas. of the incidents ( . %) occurring at schools, one took place at a nursery (pre-k) school and one incident occurred during a school board meeting that was being hosted on school property but no students were involved (neither perpetrator or victim). the remainder ( incidents) were perpetrated by or against students, faculty, and/or staff at k- schools (federal bureau of investigation ). finally, active shooter incidents ( %) did occur at institutions of higher learning. as a reminder, no incident occurred at institutions of higher learning during or . table . provides a detailed summary of educational environment incidents from to . since the beginning of , other tragic active shooter attacks have occurred in the u.s. and greatly impacted children and adolescents. two of these such events have occurred in educational environments (united states secret service national threat assessment center ). on february , , a gunman opened fire at marjory stoneman douglas high school. fourteen students and three staff members were killed while fourteen others were injured (follman et al. ) . twelve victims died inside the building, three died just outside the building on school premises, and two died in the hospital. the shooter was a former student of the school. another active shooter event occurred on may , at santa fe high school in santa fe, texas. the shooter killed ten individuals including eight students and two teachers while injuring others. the shooter was an enrolled student at the school (follman et al. ) . based on the statistics of active shooter incidents, casualties, and locations, it is vital to prepare schools and plan for such events. national preparedness efforts, including planning, are now informed by the presidential policy directive (ppd) that was signed by the president in march and describes the nation's approach to preparedness. this directive represents an evolution in our collective understanding of national preparedness based on the lessons learned from terrorist attacks, hurricanes, school incidents, and other experiences. ppd- defines preparedness around five mission areas and can be applied to school active shooter incidents. on march , , at : p.m., jeffery james weise, , armed with a shotgun and two handguns, began shooting at red lake high school in red lake, minnesota. before the incident at the school, the shooter fatally shot his grandfather, who was a police officer, and another individual at their home. he then took his grandfather's police equipment, including guns and body armor, to the school. a total of nine people were killed, including an unarmed security guard, a teacher, and five students; six students were wounded. the shooter committed suicide during an exchange of gunfire with police campbell county comprehensive high school (education) on november , , at : p.m., kenneth s. bartley, , armed with a handgun, began shooting in campbell county comprehensive high school in jacksboro, tennessee. before the shooting, he had been called to the office when administrators received a report that he had a gun. when confronted, he shot and killed an assistant principal and wounded the principal and another assistant principal. the shooter was restrained by students and administrators until police arrived and took him into custody pine middle school (education) on march , , at : a.m., james scott newman, , armed with a handgun, began shooting outside the cafeteria at pine middle school in reno, nevada. no one was killed; two were wounded. the shooter was restrained by a teacher until police arrived and took him into custody essex elementary school and two residences (education) on august , , at : p.m., christopher williams, , armed with a handgun, shot at various locations in essex, vermont. he began by fatally shooting his ex-girlfriend's mother at her home and then drove to essex elementary school, where his ex-girlfriend was a teacher. he did not find her, but as he searched, he killed one teacher and wounded another. he then fled to a friend's home, where he wounded one person. a total of two people were killed; two were wounded. the shooter also shot himself twice but survived and was apprehended when police arrived at the scene orange high school and residence (education) on august , , at : p.m., alvaro castillo, , armed with two pipe bombs, two rifles, a shotgun, and a smoke grenade, began shooting a rifle from his vehicle at his former high school, orange high school in hillsborough, north carolina. he had fatally shot his father in his home that morning. one person was killed; two were wounded. the shooter was apprehended by police weston high school (education) on september , , at : a.m., eric jordan hainstock, , armed with a handgun and a rifle, began shooting in weston high school in cazenovia, wisconsin. one person was killed; no one was wounded. the shooter was restrained by school employees until police arrived and took him into custody west nickel mines school (education) on october , , at : a.m., charles carl roberts, iv, , armed with a rifle, a shotgun, and a handgun, began shooting at the west nickel mines school in bart township, pennsylvania. after the shooter entered the building, he ordered all males and adults out of the room. after a -min standoff, he began firing. the shooter committed suicide as the police began to breach the school through a window. five people were killed; five were wounded on april , , at : a.m., su nam ko, aka one l. goh, , armed with a handgun, began shooting inside oikos university in oakland, california. he then killed a woman to steal her car. seven people were killed; three were wounded. the shooter was arrested by police later that day on august , , at : a.m., robert wayne gladden jr., , armed with a shotgun, shot a classmate in the cafeteria of perry hall high school in baltimore, maryland. the shooter had an altercation with another student before the shooting began. he left the cafeteria and returned with a gun. no one was killed; one person was wounded. the shooter was restrained by a guidance counselor before being taken into custody by the school's resource officer sandy hook elementary school and residence (education) on december , , at : a.m., adam lanza, , armed with two handguns and a rifle, shot through the secured front door to enter sandy hook elementary school in newtown, connecticut. he killed students and six adults, and wounded two adults inside the school. prior to the shooting, the shooter killed his mother at their home. in total, people were killed; two were wounded. the shooter committed suicide after police arrived taft union high school (education) on january , , at : a.m., bryan oliver, , armed with a shotgun, allegedly began shooting in a science class at taft union high school in taft, california. no one was killed; two people were wounded. an administrator persuaded the shooter to put the gun down before police arrived and took him into custody new river community college, satellite campus (education) on april , , at : p.m., neil allen macinnis, , armed with a shotgun, began shooting in the new river community college satellite campus in the new river valley mall in christiansburg, virginia. no one was killed; two were wounded. the shooter was apprehended by police after being detained by an off-duty mall security officer as he attempted to flee santa monica college and residence (education) on june , , at : a.m., john zawahri, , armed with a handgun, fatally shot his father and brother in their home in santa monica, california. he then carjacked a vehicle and forced the driver to take him to the santa monica college campus. he allowed the driver to leave her vehicle unharmed but continued shooting until he was killed in an exchange of gunfire with police. five people were killed; four were wounded sparks middle school (education) on october , , at : a.m., jose reyes, , armed with a handgun, began shooting outside sparks middle school in sparks, nevada. a teacher was killed when he confronted the shooter; two people were wounded. the shooter committed suicide before police arrived arapahoe high school (education) on december , , at : p.m., karl halverson pierson, , armed with a shotgun, machete, and three molotov cocktails, began shooting in the hallways of arapahoe high school in centennial, colorado. as he moved through the school and into the library, he fired one additional round and lit a molotov cocktail, throwing it into a bookcase and causing minor damage. one person was killed; no one was wounded. the shooter committed suicide as a school resource officer approached him berrendo middle school (education) on january , , at : a.m., mason andrew campbell, , armed with a shotgun, began shooting in berrendo middle school in roswell, new mexico. a teacher at the school confronted and ordered him to place his gun on the ground. the shooter complied. no one was killed; were wounded: students and an unarmed security guard. the shooter was taken into custody (continued) on june , , at : p.m., aaron rey ybarra, , armed with a shotgun, allegedly began shooting in otto miller hall at seattle pacific university in seattle, washington. he was confronted and pepper sprayed by a student as he was reloading. one person was killed; were wounded. students restrained the shooter until law enforcement arrived reynolds high school (education) on june , , at : a.m., jared michael padgett, , armed with a handgun and a rifle, began shooting inside the boy's locker room at reynolds high school in portland, oregon. one student was killed; teacher was wounded. the shooter committed suicide in a bathroom stall after law enforcement arrived marysville-pilchuck high school (education) on october , , at : a.m., jaylen ray fryberg, , armed with a handgun, began shooting in the cafeteria of marysville-pilchuck high school in marysville, washington. four students were killed, including the shooter's cousin; students were wounded, including one who injured himself while fleeing the scene. the shooter, when confronted by a teacher, committed suicide before law enforcement arrived florida state university (education) on november , , at : a.m., myron may, , armed with a handgun, began shooting in strozier library at florida state university in tallahassee, florida. he was an alumnus of the university. no one was killed; were wounded. the shooter was killed during an exchange of gunfire with campus law enforcement. umpqua community college (education) on october , , at : a.m., christopher sean harper-mercer, , armed with several handguns and a rifle, began shooting classmates in a classroom on the campus of umpqua community college in roseburg, oregon. nine people were killed; were wounded. the shooter committed suicide after being wounded during an exchange of gunfire with law enforcement. madison junior/ senior high school (education) on february , , at : a.m., james austin hancock, , armed with a handgun, allegedly began shooting in the cafeteria of madison junior/senior high school in middletown, ohio. he shot two students before fleeing the building. no one was killed; four students were wounded (two from shrapnel). the shooter was apprehended near the school by law enforcement officers antigo high school (education) on april , , at : p.m., jakob edward wagner, , armed with a rifle, began shooting outside a prom being held at his former school, antigo high school in antigo, wisconsin. two law enforcement officers, who were on the premises, heard the shots and responded immediately. no one was killed; two students were wounded. the shooter was wounded in an exchange of gunfire with law enforcement officers and later died at the hospital townville elementary school (education) on september , , at : p.m., jesse dewitt osborne, , armed with a handgun, allegedly began shooting at the townville elementary school playground in townville, south carolina. prior to the shooting, the shooter, a former student, killed his father at their home. two people were killed, including one student; three were wounded, one teacher and two students. a volunteer firefighter, who possessed a valid firearms permit, restrained the shooter until law enforcement officers arrived and apprehended him on january , , at : a.m., ely ray serna, , armed with a shotgun, allegedly began shooting inside west liberty salem high school, in west liberty, ohio, where he was a student. after assembling the weapon in a bathroom, the shooter shot a student who entered, then shot at a teacher who heard the commotion. the shooter shot classroom door windows before returning to the bathroom and surrendering to school administrators. no one was killed; two students were wounded. school staff members subdued the shooter until law enforcement arrived and took the shooter into custody freeman high school (education) on september , , at : a.m., caleb sharpe, , armed with a rifle and a pistol, allegedly began shooting at freeman high school in rockford, washington, where he was a student. one student was killed; three students were wounded. a school employee confronted the shooter, ordered him to the ground, and held him there until law enforcement arrived and took him into custody rancho tehama elementary school and multiple locations in tehama county, california (education) on november , , at : a.m., kevin janson neal, , armed with a rifle and two handguns, began shooting at his neighbors, the first in a series of shootings occurring in rancho tehama reserve, tehama county, california. after killing three neighbors, he stole a car and began firing randomly at vehicles and pedestrians as he drove around the community. after deliberately bumping into another car, the shooter fired into the car and wounded the driver and three passengers. the shooter then drove into the gate of a nearby elementary school. he was prevented from entering the school due to a lockdown, so he fired at the windows and doors of the building, wounding five children. upon fleeing the school, the shooter continued to shoot at people as he drove around rancho tehama reserve. law enforcement pursued the shooter; they rammed his vehicle, forced him off the road, and exchanged gunfire. the shooter's wife's body was later discovered at the shooter's home; the shooter apparently had shot and killed her the previous day. in total, five people were killed; were wounded, eight from gunshot injuries (including one student) and six from shrapnel injuries (including four students). the shooter committed suicide after being shot and wounded by law enforcement during the pursuit aztec high school (education) on december , , at approximately : a.m., william edward atchison, , armed with a handgun, began shooting inside aztec high school in aztec, new mexico. the shooter was a former student. two students were killed; no one was wounded. the shooter committed suicide at the scene, before police arrived a in a study of active shooter incidents in the united states between and , the fbi identified locations where the public was most at risk during an incident. these location categories include commercial areas (divided into business open to pedestrian traffic, businesses closed to pedestrian traffic, and malls), education environments (divided into schools [prekindergarten through th grade] and institutions of higher learning), open spaces, government properties (divided into military and other government properties), residences, houses of worship, and health care facilities. in , the fbi added a new location category, other location, to capture incidents that occurred in venues not included in the previously identified locations (federal bureau of investigation ). this table only includes educational environments. an entire list of all incidents from to at all locations can be found at https://www.fbi.gov/file-repository/activeshooter-incidents- .pdf/view (federal bureau of investigation prevention means the capabilities necessary to avoid, deter, or stop an imminent crime or threatened/actual mass casualty incident. prevention is the action schools take to prevent a threatened or actual incident from occurring. protection means the capabilities to secure schools against acts of violence and man-made or natural disasters. protection focuses on ongoing actions that protect students, teachers, staff, visitors, districts, networks, and property from a threat or hazard. mitigation means the capabilities necessary to eliminate or reduce the loss of life and property damage by lessening the impact of an event or emergency at the school. it also means reducing the likelihood that threats and hazards will happen. response means the school's or school district's capabilities necessary to stabilize an emergency once it has already happened or is certain to happen in an unpreventable way, establish a safe and secure environment, save lives and property, and facilitate the transition to recovery. recovery means the capabilities necessary to assist schools affected by an event or emergency in restoring the learning environment. it also means teaming with community partners to restore educational programming, the physical environment, business operations, and social, emotional, and behavioral health. the majority of prevention, protection, and mitigation activities generally occur before an incident, although these three mission areas do have ongoing activities that can occur throughout an active shooter incident. response activities occur during an incident, and recovery activities can begin during an incident and occur after an incident (united states department of education, office of elementary and secondary education, office of safe and healthy students ; united states department of homeland security b; united states department of homeland security ). in the k- school security guide, the u.s. department of homeland security (dhs) focuses on prevention and protection since the activities and measures associated with them occur prior to an incident ( ). effective preventative and protective actions decrease the probability that schools (or other facilities) will encounter incidents of gun violence or should an incident occur, it reduces the impact of that incident. the guide emphasizes that the level of security at a facility will be based on hazards relevant to the facility, people, or groups associated with it. it also warns that as new or different threats become apparent, the perception of the relative security changes and insecurity should drive change to reflect the level of confidence of the people of groups associated with the facility. the dhs utilizes a hometown security approach that emphasizes the process of connect, plan, train, and report (cptr) with the objective to realize effective, collaborative outcomes (united states department of homeland security b). the initial phase is connect and occurs by a school or district reaching out and developing relationships in the community, including local law enforcement. having these relationships before an incident or event can help speed up the response when something happens. each school must begin with identification or development of a security team, group, or organization. this phase also emphasizes outreach, collaboration, and building of a coalition. there should be coalition members from within a school and may include district/school administrators, teachers, aides, facility operations personnel, human resources, administrative, counseling, and student groups. external groups directly related to the school might include boards of education, parent organizations, mental health groups/agencies, and teacher and bus driver unions. external groups indirectly related to the school include all responder organizations such as police and fire departments, sheriff's office, emergency medical services, emergency management, and the local dhs protective security advisor (psa). other tangential groups such as volunteer organizations, utility providers, and facilities in close geographic proximity should also be considered. core and advisory members of the coalition are established. a coalition champion is also identified and is the person who owns the majority of the responsibility for achieving a school's security goals. the champion organizes the coalition as it grows and matures (united states department of homeland security b). the next phase is plan. this will bring the coalition together. the guide for developing high quality school emergency operations plans (united states department of education, office of elementary and secondary education, office of safe and healthy students ) is an excellent resource for the coalition. a school security survey for gun violence can be completed and the coalition or user can quickly and effectively determine a facility's security proficiency (united states department of homeland security. ). specific portions of or topics within a school plan should be assigned to individuals, committees, or working groups most qualified to address them. the planning process must be sustainable. the amount of time spent in the planning phase should be commensurate with the amount of effort expended on the other phases (united states department of homeland security b). the next phase of the process is to train on the plan developed by the coalition. determining who is responsible for what and how it should be done is the basic function of planning. in fact, telling various members of the team what is expected of them and when to do that activity is the function of training. it is vital to utilize the curricula development expertise possessed by the k- community. school administrators should take advantage of this skill set and find creative ways to address difficult topics, such as gun violence. it should be carried out in an effective and nontraumatic way. presenting the training in pieces or steps allows for a more comprehensive learning experience. it is important to validate training through exercises and drills, all of which should include the students. the training event should be followed by the completion and implementation of an after-action improvement plan with adjustment of the cptr as indicated (united states department of homeland security b). the final phase in the process is report. the reporting phase is arguably the most important of all the phases. reporting principles underlie the other three phases and have profound prevention and protection impacts by driving forward information. dhs models the reporting phase using the "if you see something, say something ® " campaign (u.s. dhs, ) and the nationwide suspicious activity reporting (sar) initiative (nationwide suspicious activity reporting initiative (nsi) ). "if you see something, say something ® " focuses on empowering anyone who sees suspicious activity to do something about it by contacting local law enforcement, or if an emergency to call - - (united states department of homeland security a). this is a compelling capability when well organized and managed. a good plan for reporting, especially for a k- school, involves training staff and students on what is considered suspicious. there are many methods in which schools can employ to facilitate this, such as dedicated telephone numbers, websites for anonymous reporting, email or text messaging, and mobile phone applications. conducting simple drills for reporters and receivers keeps skills sharp and reinforces the importance of the effort with the goal to save lives. if the plan includes sharing all suspicious activity calls with the local fusion center then the probability of higher fidelity reporting increases (united states department of homeland security b). when making changes to a school's plans, procedures, and protective measures, it is imperative the needs of individuals with special health care needs be addressed throughout the process. planning, training, and execution should always consider accessible alert systems for those who are deaf or hard of hearing; students, faculty, and staff who have visual impairments or are blind; individuals with limited mobility; alternative notification measures; people with temporary disabilities; visitors; people with limited english proficiency; sign cards with text-and picture-based emergency messages/symbols; and involving people with disabilities in all planning (united states department of homeland security, interagency security committee ). it is important to understand that no "profile" exists for an active shooter (united states department of education, office of elementary and secondary education, office of safe and healthy students ). however, research indicates there may be signs or indicators. o'toole ( ) presents an in depth, systematic procedure for school shooter threat assessment and intervention. the model was designed to be used by educators, mental health professionals, and law enforcement agencies. its fundamental building blocks are the threat assessment standards, which provide a framework for evaluating a spoken, written, and symbolic threat, and the fourpronged assessment approach which provides a logical, methodical process to examine the threatener and assess the risk that the threat will be carried out. schools should learn the signs of a potentially volatile situation that may develop into an active shooter situation and proactively seek ways to prevent an incident with internal resources, or additional external assistance (united states department of education, office of elementary and secondary education, office of safe and healthy students ). potential warning signs of a school shooter may include increasingly erratic, unsafe, or aggressive behaviors; hostile feelings of injustice or perceived wrongdoing; drug and alcohol abuse; marginalization or distancing from friends and colleagues; changes in performance at work or school; sudden and dramatic changes in home life or in personality; pending civil or criminal litigation; and observable grievances with threats and plans of retribution (united states department of homeland security b). at a minimum, schools should establish and enforce policies that prohibit, limit, or determine unacceptable behaviors and consequences of weapons possession/use, drug possession/use, alcohol/tobacco possession/use, bullying/harassment, hazing, cyber-bullying/harassment/stalking, sexual assault/misconduct/harassment, bias crimes, social media abuse, and any criminal acts (united states department of homeland security b). in addition to policies and positive school climates, school districts and administrators should establish dedicated teams to evaluate threats, such as a threat assessment team (tat). the team should include mental health professionals (e.g., forensic psychologist, clinical psychologist, and school psychologist) to contribute to the threat assessment process (united states department of homeland security b). it is the responsibility of the tat to investigate and analyze communications and behaviors to make a determination on whether or not an individual poses a threat to him/herself or others (united states department of education, office of elementary and secondary education, office of safe and healthy students ). as well as tats, some schools have even opted to establish social media monitoring teams which look for keywords that may indicate bullying or other concerning statements. if a school opts to create such a team, it should work very closely with the tat to ensure that applicable privacy, civil rights and civil liberties, other federal, state and local laws, and information sharing protocols are followed. please refer to chap. for further information. after an active shooter incident, field triage (e.g., jumpstart) must commence and the patient must be evaluated by an experienced emergency medicine or trauma surgeon, preferably by a pediatric specialist in those disciplines. if an active shooter incident is coupled with detonation of an explosive device, the child must be screened and decontaminated for radiation exposure ("dirty bomb"). triage tags are extremely helpful when multiple victims present in a short period of time. medical response to an active shooter event will focus on control of external hemorrhage along with circulatory stabilization. operative emergencies will be common and receive the highest priority. severe extremity injuries may be controlled with tourniquet application or other forms of hemorrhage control. re-evaluation is paramount to prevent ischemia to distal regions. however, thoracic or abdominal (truncal) injuries will need immediate surgical exploration and intervention. penetrating trauma will cause more vascular injuries than blunt trauma, and vascular surgical trays may be in short supply at a hospital. major procedure or surgical trays may become short in supply based on the increased operative demand. resuscitative blood transfusion therapy may utilize a massive blood transfusion protocol. since whole blood may be short in supply, some will simply use the : : rule (administer one unit of packed cells: one unit of fresh frozen plasma: one unit of platelets). a unit for children may be substituted as an aliquot based on size of the patient (e.g., administer ml/kg of packed cells: ml/kg of fresh frozen plasma: ml/kg of platelets). calcium must also be replaced when there is a large volume transfusion. due to extensive blood product utilization, there may be a heavy impact on institutional or regional blood supplies. plans should be in place to address these problems, including the implementation of allocation of scarce resources. mental health support and staff debriefs are essential and should be included after an active shooter event (hick et al. ). in conclusion, all forms of disasters, whether man-made or natural, impact infants, children, and adolescents throughout the world. effective and efficient interventions remain the cornerstone of sustaining a child's well-being while reducing untoward complications due to all forms of disasters. having a deep understanding of pediatric physiology and pathophysiology is crucial to all levels of disaster diagnostics and therapeutics. all nurses and hcps have an obligation to understand these principles and deliver excellent, compassionate care to the pediatric disaster victim. advanced law enforcement rapid response training evidence-based support for the all-hazards approach to emergency preparedness ahls advanced hazmat life support provider manual active shooter incidents in the united states in and radiation disasters and children-committee on environmental health apls: the pediatric emergency medicine resource textbook 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d cjeec authors: d’alessandro, daniela title: urban public health, a multidisciplinary approach date: - - journal: urban health doi: . / - - - - _ sha: doc_id: cord_uid: d cjeec urban environment is a highly complex interactive socio-physical system, with competing expectations and priorities. public health interventions have always had a fundamental role in the control of diseases in cities. who considers urbanization as one of the key challenges for public health in the twenty-first century, since cities offer significant opportunities to improve public health if health-enhancing policies and actions are promoted. a multidisciplinary approach is required, but the basic differences existing between technical and health disciplines make the interaction difficult. the multidisciplinary collaboration is still at a very early stage of development, and needs to be further understood and planned. the author concludes stressing the need for a transversal training, but also for sharing knowledge, instruments and methods, involving all the actors in the planning process, to develop a real multidisciplinary approach. public health interventions have always had a fundamental role in the control of diseases in cities [ ] [ ] [ ] . a growing body of research has documented that the action of urban environment in shaping health and disease is itself of interest. understanding which are the urban factors relevant for health can enrich the positive aspects of urban living and lead to develop appropriate behaviours and to identify preventive measures. this is also the pivotal topic in many documents produced by who [ ] [ ] [ ] [ ] [ ] [ ] [ ] . actually, we know that the urban environment is a highly complex interactive socio-physical system, with competing expectations and priorities [ ] . several factors, related to the built environment, are directly responsible for health impacts [ ] . they include air quality, both indoor and outdoor, climate, water quality and quantity, noise and traffic-related injuries. much of the evidence concerning direct impacts is quantifiable and causal effects can precisely be attributed [ , ] . other factors, including the ways in which built environment features and their design (housing, neighbourhoods, social environments, connectivity, density, land use mix, accessibility, amenities and decision-making processes), have an indirect impact, because they are able to influence the feeling and behaviour of individuals and population [ ] . for most of these impacts in recent years several evidences have been collected, documenting their relationship with health and these results are fundamental in the definition of salutogenic cities [ , , ] . this is nothing of new. in the past, the disciplines of public health and urban planning were tightly intertwined. with the introduction of a deeper knowledge of microorganisms, infectious diseases and vaccinations, however, the focus of public health moved away from community engineering and urban design and going towards a model based only on strict medical principles [ ] . these discoveries opened the way to targeted medical interventions aimed at preventing and curing communicable diseases. it was thus possible to control most of them diseases, at least in developed countries [ ] . consequently, from to infant mortality rate has been massively reduced. in italy, for example it dropped from to ‰. on the contrary, in the same period, life expectancy at birth passed from about to . years and the natality rate decreased from ‰ to ‰ live births, with an acceleration of this decline after the early s. the mortality from all causes decreased from ‰ to about ‰ (crude rates), with a cross between natality and mortality curves in [ ] . the fall in mortality for communicable diseases and the exceptional life prolongation explain why chronic diseases became the predominant cause of death during the twentieth century. in fact, the incidence of this kind of diseases grows exponentially with age. at the same time, after smallpox, other epidemiologically important infectious diseases are close to disappearing, but new epidemics are occurring in recent years, mainly related to climate change and to instability, poverty and conflict in many parts of the world. both chronic diseases and new infections find the cities the place of their most expression. as argued by who [ ] , following this shift, public health and urban planning became separated across the world. for long time, mainly during the period of economic prosperity and improvements in medical technology, the urban inequalities in health persisted, the divary increased and the dialog among them became more difficult, because objectives and interest felt far one from the other. those who mostly suffered this dichotomy and the health consequences (both chronic and communicable diseases) were the members of poorer social class and economically disadvantaged urban population [ , [ ] [ ] [ ] [ ] [ ] [ ] . in the the institute of medicine published the report "the future of public health", in which leaders in the field agreed that the nation's public health activities were in confusion and that the field needed to refocus its efforts to address growing inequalities in health across population groups [ , ] . by the s, public health researchers of some western countries began to reconceptualise the risk factors for the uneven distribution of diseases across populations in order to explain health disparities, energizing the field of social epidemiology [ ] . this discipline, by emphasizing distribution as distinct from causation, pushed public health scholars to reconsider how and why poverty, economic inequality, stress, discrimination, and social capital become "biologically embodied" and help explain persistent patterns of inequitable distributions of disease and well-being across different population groups and geographic areas [ ] . the commission on social determinants of health drew attention to how transport patterns, access to green spaces, pollution effects, housing quality, community participation, and social isolation were all structured by social inequality [ , , ] . as already discussed in some previous papers [ , ] , by the end of the twentieth century, a split emerged in public health between those emphasizing the biomedical model and focusing on fighting individual disease risk factors, and social epidemiologists, who emphasized the idea of improving neighbourhood conditions, eliminating poverty, and enhancing social resources for health. to find something similar, it is necessary to go back to the second half of the eighteenth century, when west european countries understood that better living conditions would have increased city residents' physical and mental health, but also boosted moral and economical status of the population [ , ] . in the same period, in germany, rudolf virchow, having understood that poverty and hunger lead to epidemics and that, in order to avoid them, political reforms were necessary [ ] , wrote "medicine is a social science, and politics is nothing else but medicine on a larger scale" [ ] . at the end of the second half of the twentieth century the drop of mortality for cardiovascular and cerebrovascular diseases is a reality in most countries in the world, which may be ascribed to important improvement in prevention, diagnosis and therapy, but also to changes in lifestyle and environmental conditions. past that era, a lot of things have changed. today health can mean different things to different people. one of the most pertinent definitions of health is that from the constitution of the world health organization [ ] . this statement is the evidence that years ago, public health moved progressively away from the medical model-focused on the individual and on interventions targeted to treat diseaseback towards a social model, considering health as an outcome of the effects of socioeconomic status, culture, environmental conditions, housing, employment and community influences. today cities are energetic hubs of creativity and power, learning and culture. they are ecosystems that support growth and change, and are now home to more than half of the world's population-a proportion expected to reach two thirds by [ ] . the who has identified urbanization as one of the key challenges for public health in the twenty-first century [ ] , since cities offer significant opportunities to improve public health if health-enhancing policies and actions are promoted [ , ] . however, as the world continues to become more complex, the challenge is to fight for a framework in which scholars from multiple disciplines can effectively work together with a common aim: creating healthy, sustainable and equitable cities. while it is true that health and urban planning were successful partners long time ago, this is more difficult to reach today, because rests on building a respectful relationship out of mutual understanding and practical engagement across these disciplines [ ] . the theme of multidisciplinarity has been very much discussed along the last decade, since the complexity of problems and processes to be managed at various levels (e.g. research, local governance, policy), need a new approach and methods able to analyse more in depth the problems and to find integrated and effective solutions. in the research field, the importance of multidisciplinarity has been widely recognized. it occurred not only in emerging areas such as the new infectious diseases (e.g. hiv, ebola, sars-cov, studies), the nanotechnology applications, etc., but even in more traditional fields, such as physics or applied math. multidisciplinarity does not mean a simple cooperation for improvement, at least at academic level. zuo and zhao [ ] , in order to evaluate whether a higher level of multidisciplinarity within an academic institution was associated with true internal collaborations, revised , publications by faculty members in over academic institutions belonging to three multidisciplinary areas (information, public policy, and neuroscience). they observed that many multidisciplinary institutions were not necessarily practicing true collaboration, although they did feature collaborations that are more interdisciplinary. speaking about urban environment, it is to be underlined that cities around the world face many health challenges, including air, water and soil pollution, traffic congestion and noise, and poor housing conditions, and all these situations are caused and worsened by unsustainable urban development and climate change. a multidisciplinary assessment of these criticalities offers opportunities for integrated low carbon solutions in the urban environment, that can bring multiple benefits for public health [ ] . for example, to achieve high walkability, it is crucial to involve town planners and health workers, but this is not enough; it is mandatory also to incorporate thoughts about health and health promotion into regulation plans, to stimulate cultural and commercial activities, and to ensure good maintenance and safety [ , , ] . the efforts that combine the perspectives of different disciplines, that use quantitative and qualitative approaches when appropriate, are more likely to provide answers about both how and why the characteristics of urban living may affect health. quantitative and qualitative methods may help each other to minimize the a priori decisions; however, the typical interdisciplinary practice involves people with disparate backgrounds and, frequently, for them, the sense of words assumes different meanings depending on which discipline is involved; and researchers and practitioners, schooled in different academic traditions, have to face considerable challenges when working together [ , ] . in particular, as argued by kent et al. [ ] , health and built environment professionals do not need to become technical experts in each other's field, but they simply must work together to capitalise on each other's particular skill. this requires understanding, and the development of this understanding should be the focus of professional development, rather than the explicit development of a technical skill set. actually, there is little shared vocabulary among disciplines and this is a problem, because cities are multi-dimensional systems influenced by trends and processes operating at local, national or supranational levels [e.g. global initiatives that address urban issues, such as the sustainable development goals (sdgs)] [ ] . it follows that health and environmental issues, like climate change or the growing populations, need to be addressed using "holistic" approaches that require the development of multidisciplinary research synergies focused on urban health, accompanied by multidisciplinary sustainable interventions. for example, urban energy systems have interactions and influence wherein the socio-technical sphere is expanded to political, environmental and economic spheres as well. in addition to the inter-sectoral linkages, the diverse agents and multilevel governance trends of energy sustainability in the dynamic environment of cities make the urban energy landscape a complex puzzle [ ] . a basic difference among technical and health disciplines, that can make interaction difficult, regards the "evidences". for example, the nature of evidence that planners use to develop their policy is different from that used by public health workers (e.g. lack of standardisation in measurement of environmental and health variables). however, as noted by kent et al. [ ] , "it must be recognised that the way people live and move around a place cannot be subject to the methods employed to produce the standard of evidence traditionally used to underpin health policy decisions….". a more comprehensive way to explore and understand the complex issues needs to be embraced, including the use of case studies, in-depth observations, environmental and social impact assessment, etc. lawrence [ ] argues that interdisciplinary contributions highlight the difference between disciplines and suggests to apply a transdisciplinary approach. this kind of contribution crosses the boundaries of scientific knowledge, to account for other types of knowledge (professional know-how, tacit knowledge, etc.). transdisciplinary contributions create a knowledge domain broader than interdisciplinary contributions; they are based on the coproduction of knowledge by actors and institutions for socially accepted projects that are meant to impact on real world situations. in conclusion, the multidisciplinary collaboration is still at a very early stage of development, and needs to be further studied, understood and planned. as argued by grant et al. [ ] , today public health needs to add a fourth arm to its traditional remit of "(a) protecting and promoting health, (b) preventing ill-health and (c) prolonging life": it has to actually "create health" by means of investigating and understanding how possible it is to create the conditions for good health and wellbeing and equitable access to them. this concept is central in health promotion activities and it is an integral part of the "salutogenic city" definition [ ] . at the same time, urban designers are grappling with a similar concept when they start to define their term liveability. to face up to complex issues, whose causes lie beyond the traditional remit of the health sector, it is necessary to share knowledge from many sectors for obtaining that this fourth arm could realize its goals. nevertheless collaborative activities involving professionals trained in different cultural areas are still marginal. more transdisciplinary contributions [ ] are required in order to address the complexity of health-related problems at urban scale and implement effective responses to real-world situations. these kinds of contributions offer a broad integrated perspective, which should be part of the training in universities and of the professional training in today's era of complexity. barton et al. [ ] suggest that an ideal health-integrated planning system should have five key elements: (a) acceptance of interdepartmental and intersectorial collaboration to properly explore health implications and to integrate the solutions across institutional remits; (b) strong political support, to ensure a consistent approach and the resources needed; (c) full integration of health with other local policy: placing health at the heart of plan-making; (d) active involvement of stakeholders (e.g. citizens) in the policy process; (e) a planning approach that fully reflects health objectives and makes them explicit (quality-of-life monitoring, health impact assessment, strategic sustainability assessment, urban potential studies). as argued by ryden et al. [ ] , improving health in cities implies to realize numerous small-scale interventions, selecting those effective, encouraging selforganization by citizen, and constantly modifying approaches as the system continually changes and adapts. obviously, the assessment of these various experiments is fundamental. such assessment should be based on observation, dialogue, discussion and deliberation, rather than on a technical exercise done by external experts. for example, a regeneration project aimed at increasing social cohesion, must consider the values and the priorities of local dwellers. it could be useful to ask their contribution-involving in vivo actors and stakeholders-to understand whether this project contributes to, or hinders the change. in-depth consultation, mediation, and deliberation are all processes that can be used to engage stakeholders in detailed and problem-orientated argumentation, to deliver potential solutions in the policy-making process. transdisciplinary knowledge production has to move beyond conventional research agendas, to address real world concerns, to address societal challenges in many domains that require collective understanding, political commitment, and innovative responses. as lawrence argues, speaking about housing and health [ ] , today there is no shared understanding about an interdisciplinary and a transdisciplinary epistemology in this field. therefore the formulation and application of shared conceptual and methodological frameworks (for research and action) should be an objective of this field of inquiry in the immediate future. in conclusion, there is a transversal need of training, but also of sharing of knowledge, instruments and methods, for all the figures involved in the planning process, to develop a real multidisciplinary approach. the road is long, and we have just begun the journey. history of public health urban health: a new discipline public health and urban planning: a powerful alliance to be enhanced in italy united nations global report on urban health: equitable healthier cities for sustainable development. world health organization a framework for public health action: the health impact pyramid world health organization healthy design and urban planning strategies, actions, and policy to achieve salutogenic cities strategies for disease prevention and health promotion in urban areas: the erice charter shaping cities for health: complexity and the planning of urban environments in the st century healthy urban planning in practice: experience of european cities the built environment and health: an evidence review a systematic review of built environment and health the application of salutogenesis in cities and towns healthy cities and the city planning process. a background document on links between health and urban planning the epidemiological revolution of the th century reconnecting with our roots american urban planning and public health in the twenty-first century what can be done about inequalities in health who european review of social determinants of health and the health divide social inequities in environmental risks associated with housing and residential location a review of evidence action on the social determinants of health moving environmental justice indoors: understanding structural influences on residential exposure patterns in low-income communities social epidemiology epidemiology and social sciences: toward a critical reengagement in the st century revolutions in public health: , and città e piani d'europa. la formazione dell'urbanistica contemporanea. dedalo ed. bari . wittern-sterzel r ( ) politics is nothing else than large scale medicine rudolf virchow and his role in the development of social medicine constitution of the world health organization ) health amd the built environment: exploring foundations for a new interdisciplinary profession the more multidisciplinary the better?-the prevalence and interdisciplinary of research collaborations in multidisciplinary institutions challenges and opportunities for urban environmental health and sustainability: the healthy-polis initiative how walkable is the city? application of the walking suitability index of the territory (t-wsi) to the city of rieti the pleasure of walking: an innovative methodology to assess appropriate walkable performance in urban areas to support transport planning facilitating interdisciplinary research urban health: evidence, challenges ad direction the framework of urban exposome: application of the exposome concept in urban health studies a complex approach to defining urban energy systems constancy and change: key issues in housing and health research cities and health: an evolving global conversation healthy urban planning in european cities key: cord- -afgvztwo authors: nan title: engineering a global response to infectious diseases: this paper presents a more robust, adaptable, and scalable engineering infrastructure to improve the capability to respond to infectious diseases.contributed paper date: - - journal: proc ieee inst electr electron eng doi: . /jproc. . sha: doc_id: cord_uid: afgvztwo infectious diseases are a major cause of death and economic impact worldwide. a more robust, adaptable, and scalable infrastructure would improve the capability to respond to epidemics. because engineers contribute to the design and implementation of infrastructure, there are opportunities for innovative solutions to infectious disease response within existing systems that have utility, and therefore resources, before a public health emergency. examples of innovative leveraging of infrastructure, technologies to enhance existing disease management strategies, engineering approaches to accelerate the rate of discovery and application of scientific, clinical, and public health information, and ethical issues that need to be addressed for implementation are presented. powerful antibiotics and vaccines helped mitigate the threat from infectious diseases for several generations. in , most human deaths were associated with infectious diseases like tuberculosis and influenza. as recently as , the worldwide mortality associated with infectious diseases was . percent of deaths from all causes. in , this had continued to decline to . percent. unfortunately, this means there were still over million deaths associated with infectious diseases [ ] . a recent review examined antimicrobial resistance and predicted that by , the impact would include a reduction of the world's potential gross domestic product by % to . % and cause an additional million premature deaths a year [ ] . although beyond the scope of this paper, it is worth noting that microorganisms have also been implicated as contributing to or causing many chronic diseases, including some forms of cancer, arthritis, and neurological disease [ ] . it is tempting to approach the infectious disease challenge as doing battle with a pathogen enemy where brigades of combatant bacteria or viruses are held back or even defeated by increasingly sophisticated pharmaceutical weapons. there is certainly a place for improved pharmaceuticals; however, a sustainable approach will need to be much more sophisticated. microbes and their hosts form a complex and dynamic ecosystem, and a long-term strategy for infectious disease control must take into account the fact that diseases can result from changes in the microbe, the host, or the environment. it is time to move beyond the simple war metaphor [ ] . to compound the challenge, microbes are notoriously fast in adapting to new environments. this can include bacteria developing antibiotic resistance or acquiring metabolic traits that allow them to thrive in a new environmental niche, and viruses evolving to reduce the effectiveness of antivirals and vaccines. in addition to the evolution of existing pathogens, like the seasonal influenza virus, there are emerging pathogens that are often the result of changing or encroachment upon new ecosystems and the ''leap'' from a conventional host to a new host species. an example from recent headlines is the middle east respiratory syndrome coronavirus. mers-cov appears to have reached humans by direct contact and potentially airborne transmission through animal hosts including camels [ ] . the mers-cov is related to the coronavirus that caused severe acute respiratory syndrome (sars). the sars outbreak began in and likely spread to humans via bats [ ] . although the viruses are similar, this does not guarantee that utilization of the same medical and public health intervention techniques will be effective. there are many examples of emerging infectious disease outbreaks, including the on-going hiv/aids pandemic that has already caused million deaths [ ] . each pathogen involved in an infectious disease outbreak provides an opportunity to identify what scientific data are needed to support effective interventions. quoted in the global health security agenda [ ] , u.s. president obama said in ''. . . we must come together to prevent, and detect, and fight every kind of biological dangervwhether it's a pandemic like h n , or a terrorist threat, or a treatable disease.'' the agenda complements and supports existing international health regulations of the world health organization [ ], u.s. public health [ ] , [ ] , and biodefense objectives [ ] - [ ] . the framework for data requirements and response priorities used in this paper integrates across these initiatives and regulations. specifically, in order to manage infectious diseases, capabilities are required for: preparedness, detection, characterization, response, and support for the return to normal, see fig. . this framework is analogous to homeostasis in living organisms. these capabilities are relevant for addressing health interests from the global to the individual organism, e.g., human, animal, plant, or bacterium. the global perspective is studied and implemented by public health, ecological, industrial, and other communities with the principal foci of public benefit, humanitarian needs, scaling, and statistical measures. for an individual human, the perspectives are from medical, economic, relationship, and other personal priorities with the foci of individual health, quality of life, and gaining access to effective care. integrating frameworks are needed to support optimization of technical, economic, medical, and ethical components of this complex system. infectious diseases are a major cause of death and economic impact worldwide. a more robust, adaptable and scalable infrastructure would improve the capability to respond to epidemics. because engineers contribute to the design and implementation of infrastructure, there are opportunities for innovative solutions to infectious disease response within existing systems that have utility, and therefore resources, before a public health emergency. examples of innovative leveraging of engineered infrastructure are provided throughout the paper. the next section of this paper discusses opportunities for technology to improve on current approaches to infectious disease management and the following section discusses engineering challenges to accelerate the application of science to infectious disease planning and response at the global scale. i conclude with a brief discussion of the importance and opportunity for engineers to address the ethical issues needed to leverage traditional infrastructure for infectious disease response and help nurture a global culture of responsibility in both healthcare and technical applications. leveraging their significant investment in planning and response experience, i adopted from the u.s. pandemic influenza plan [ , p. g- ], infectious disease management goals to provide: public health policy-makers with data to guide response, and clinicians with scientific data to justify recommended treatments, vaccines, or other interventions. i have integrated priorities from the influenza plan with a more pathogen-centric approach from the food industry [ ] in table to provide descriptions of priority data to support infectious disease outbreak response. health have parallels shown in the inner and outer rings, respectively. because traditional diagnostics and treatments have long lead development, regulatory approval, and manufacturing lead times, it is challenging to provide timely and effective interventions at a public health scale for an outbreak caused by an emerging or novel pathogen. approaches to achieving robust, economically viable scaling include improved leveraging of existing infrastructure, establishment of an integrating framework like the digital immune system for optimization, and spiral development processes similar to homeostasis. these data can be provided with currently available technologies. however, there are several recurring issues that inhibit global utilization. the issues that can be addressed, even if only partially, by technology are discussed. the key recurring issue is availability. limited availability is driven by many factors including cost, appropriate sharing of data and materials, and timely manufacture and distribution. on a more basic level, one of the key factors in sustainable preparedness is infrastructure, and availability is a challenge here as well. malnutrition due to starvation, unsafe water, and insufficient sanitation all impact infectious disease mortality. in , over half of the deaths of children under five years old were associated with infectious diseases and the significant contributing factor for many of these deaths was under nutrition [ ] . building the infrastructure to eliminate these hazards has historically been the domain of civil and agricultural engineers. electrical and computer engineers are now providing valuable low-cost information linkages across systems so that weather satellite data can be utilized to help increase local crop yields and prepare water treatment and sanitation plants for adverse weather. the computational algorithms and information networks can be applied worldwide for irrigation and weather prediction for storm and drought management [ ] . remote sensing has been utilized to indirectly detect vibrio cholera [ ] and predict a rift valley fever (rvf) outbreak [ ] . in both of these examples, the disease and environmental biology were shown to correlate with changes that could be measured by air and space borne sensors. for v. cholerae, sea-surface temperature and sea height were linked to the inland incursion of water with commensal plankton. satellite measurements of seasurface temperature, rainfall, and vegetation changes were used to predict the areas where outbreaks of rvf in humans and animals occurred in africa. the techniques and data used for rvf may be more broadly applicable to other vector-borne diseases. in regions with limited infrastructure, it is often difficult or impossible to provide the refrigeration required to maintain the ''cold chain'' for life-saving vaccines and other medicines. an inspirational consortium of industry, churches, and nonprofits in zimbabwe, africa, leveraged the reliable power requirements of cellphone towers to help address the refrigeration storage needs for many vaccines [ ] . the initiative has included innovative contributions by wireless providers, refrigerator manufacturers, and others in order to help provide immunizations against polio, measles, and diphtheria. another area in which technology is poised to impact infectious disease management is in gaining timely situational awareness of outbreaks. global and regional travel often make this a difficult task, and data collection and sharing for epidemiologists, care providers, patients, and the public is also limited by other factors such as privacy concerns for individual patients' medical data, governmental goals to protect tourism and other local-to-national interests, the lack of recognized standards for sharing protected data, and an accepted international norm for transfer of public and commercial material during and in response to an infectious disease. improved network, encryption and access information technologies are also necessary to support managed care organizations and telemedicine applications. a global system addressing these issues and capable of operating on time scales relevant to controlling an epidemic is needed. a comparison of five outbreak detection algorithms was conducted using a surveillance case study of the seasonal ross river virus disease [ ] . challenges were identified for making quantitative comparisons of the algorithms as well as in evaluating the performance of each algorithm. a network model has been proposed that has the potential to address algorithm shortcomings for outbreak localization and performance under changing baselines [ ] . this is accomplished through modeling the relationships among different data streams rather than only the time series of one data stream compared to its historical baseline. using measured and simulated data, this approach showed promise for addressing shifts in health data that occur due to special events, worried well, and other population shifts that happen during significant events like pandemics. another study compared animal and public health surveillance systems, finding challenges due to a limited number of common attributes, unclear surveillance objectives of the design, no common [ ] . privacy issues pose challenges that are difficult to address with technology, but they have been addressed in some applications through voluntary enrollment. for example, the geographic location capability in many cell phones allows applications to push public health and animal disease outbreak information to users based on location. the u.s. centers for disease control and prevention (cdc) has the fluview application that provides geographic information on influenza-like illness activity [ ] . obviously, the pervasiveness of cell phones improves timely reporting from the field for both the public and the public health profession. moving forward, addressing privacy issues will be critical so that geographic tracking of a phone's location could be used to help inform an individual of potential contact with infected persons or animals and support automated, anonymous, electronic integration of those data to accelerate the epidemiological detective work of identifying and surveying those same individuals for public health benefit. electronic health information systems have made significant progress. however, even as recently as , it was noted: ''despite progress in establishing standards and services to support health information exchange and interoperability, practice patterns have not changed to the point that health care providers share patient health information electronically across organizational, vendor, and geographic boundaries. electronic health information is not yet sufficiently standardized to allow seamless interoperability'' [ ] . the u.s. has taken a risk-based approach to health information technology (it) regulation [ ] . safety in health it has been recognized as part of a larger system that needs to consider not just specific software, but how it interacts with the it system and how it will be used by clinicians [ ] . continued development of quality management, human factors, and other standards to support usability and regulatory review are needed. as the large-scale systems that require computer algorithms to scan and integrate data into summary reports continue to progress, significant benefit is being derived from systems with fairly simple technology. in , promed was started as the first e-mail reporting system with curation. it has grown to over , subscribers in over countries and has roles in outbreak detection including sars in [ ] . there are many health alert networks (han) that utilize websites and electronic communications [ ] , [ ] . a study in new york city showed that most physicians ( %) received health department communications, but less than half of those ( %) received the information through the han [ ] . an important trend is that % prefer e-mail distribution of communications and this preference trends with younger respondents. looking to the future, achieving the benefits of distributed diagnostics and electronic reporting will depend on both technical and clinical integration. this would improve individual care as well as reduce or eliminate separate data entry and reporting for public health surveillance. in order to realize the benefits of personalized medicine with treatment customized to the individual, the costs, scalability, and compatibility across all data sources must be addressed. personalized infectious disease medicine might include customization of antimicrobials to an individual patient to improve care and help reduce overuse and misuse of antibiotics. similarly at the global health scale, timely identification of appropriate virus strains coupled with rapid manufacturing for seasonal influenza vaccination would reduce the disease burden of thousands. in personalized and global applications, the approaches will need to move from diagnostics, characterizations, and interventions aimed at a single specific disease causing pathogen to robust methods that can be adapted for safe and effective use in a timely manner for broad classes of disease. fully realizing these goals will require improved scientific understanding and new engineering and computational approaches. there are significant challenges in utilizing traditional engineering approaches in the life sciences. living organisms are complex by most machine standards. individual organisms are also typically influenced by peer organisms forming a community, by other living organisms that may be beneficial, neutral or detrimental, and by the environment. there are opportunities for engineers to develop improved measurement, analysis, and model systems to better characterize, predict and manage infectious diseases. given the complexity of these interacting systems, there are significant challenges to the reductionist approaches familiar to design-based engineering. fortunately, as the history of vaccination demonstrates, a comprehensive knowledge of the biology is not always required in order to provide healthcare benefits. with the advent of deoxyribonucleic acid (dna) sequencing and the efficient detection and laboratory replication of dna through polymerase chain reaction (pcr) amplification, there are opportunities to organize scientific and medical data using dna-based indices. the field that has grown up around these technologies, genomics, is an excellent example of how engineering can enable profound advances in biological research. a significant contributor to the organizing principles and demonstrator of this dnabased approach, carl woese, summarized in the impact as providing ''a new and powerful perspective, an image that unifies all life through its shared histories and common origin, at the same time emphasizing life's incredible diversity and the overwhelming importance of the microbial world,'' [ ] . here, i build on this insight as well as our previous assessment in of the engineering contributions and opportunities related to dna sequence fitch: engineering a global response to infectious diseases data that describe an organism's genome, transcriptome and proteome [ ] . as depicted in fig. , nucleic acid sequence provides a common framework to organize data related to infectious diseases. today's dna sequencing instruments can produce terabases of data in a few days with per-base costs a million-fold lower than a decade ago. recent studies have demonstrated the power of personalized approaches to major human diseases like cancer. it appears likely that the next few years will bring the personalized human genome and the miniaturized sequencing instrument, each for less than one thousand dollars. now is the time to innovate and apply the engineering approaches needed to utilize these and other data. dna sequencing and the associated bioinformatics tools for analysis provide a powerful methods-based approach to monitoring living systems. dna and ribonucleic acid (rna) provide data that help characterize an individual's health status as well as the status of the surrounding environment. because sequencing converts biological information to digital data, computer networks, data management, integrity, scaling, analysis, privacy, and affordability are keys to expanding access. the ''digital immune system'' is a powerful concept that generalizes the method to population dynamics and public health [ ] . basing the system on dna allows correlation techniques to identify patterns in the sequence datavrecurring and deviate patterns. these patterns can be indicative of healthy or pathologic host status as well as the absence or presence of pathogens in clinical and environmental samples. the growth of sequence databases with appropriate clinical and environmental metadata will improve the potential quality of the analyses and the impact on individual and public health. growing databases will also need to address the scaling and privacy issues. one of the most powerful features of the digital immune system approach is the potential to detect a novel pathogen, i.e., one that is not already in the database. the flexibility inherent in this methodbased approach is a huge strength and distinguishes it from many of the traditional methods which are not able to detect or characterize a new or emerging pathogen. seasonal influenza provides an example of a system of method-based opportunities. the influenza virus changes genetically as it uses an error-prone enzyme to replicate its genome, and mutates further as it migrates from host-tohost, across speciesve.g., waterfowl to humans, and across ecosystems of the environment. this mutation process gives rise to a different population of viruses in circulation each year, and poses a challenge to vaccine manufacturers, as one year's vaccine will typically have little value when confronted with the next year's viral strains. each year's vaccine is constructed specifically to protect against the strains that are projected to be dominant in the upcoming flu season. the current process uses egg-based techniques for manufacturing influenza vaccine and has been successfully utilized for decades as have the techniques for isolating and identifying emerging strains of the virus. unfortunately, the combined pipeline is relatively slow and does not typically allow for vaccine manufacturing to be based on strains that have been detected at the start of the flu seasonvvaccine production must be started earlier, and so relies heavily on imperfect predictions as to which strains of influenza will dominate. rna sequence data provide a method-based framework for managing influenza response at the global scale. in addition to the detection and identification of the virus, sequence data can be utilized to compare and predict the performance of egg and other manufacturing approaches. as the sequence, clinical, animal, and environmental data are accumulated, there is also the potential to support computational safety and efficacy screening. shortening the current timeline from detection through vaccination would have significant positive health benefits. there are method-based approaches to vaccine manufacturing with significant potential to improve upon the egg-based approach. even though the influenza virus has only eight genes and an ominous history of multimillion death pandemics, the scientific understanding is not yet sufficient to avoid the thousands of deaths annually from seasonal influenza nor to mitigate the potential from a pandemic strain. complex samples to be converted to nucleic acid sequence data that are easily represented in a digital computer. these data can be used as a framework or index for health and disease related metadata supporting correlative studies across species and providing insight into infectious diseases. because genetic material is traded among organisms and is often part of complex nonlinear networks within an organism and beyond, increased collection and interpretation of the associations across dna sequence and metadata are needed. a digital immune system for individuals and populations is envisioned that identifies causation and intervention options to support patient-specific and public health interventions. biocontainment laboratories are needed to safely conduct the research needed to understand pathogens as well as analyze clinical samples. characterization of existing pathogens increases understanding of current diseases and also helps to prepare for emerging diseases. laboratories that work with infectious agents are categorized by biosafety level (bsl) ranging from a basic biomedical laboratory (bsl- ) to bsl- laboratories (fig. ) that can safely handle untreatable disease agents [ ] . the engineering systems for automatically controlling airflow and other facility safety components are critical for supporting clinical and research laboratories. infectious disease research is benefiting from ''omic'' methods for characterizing proteins (proteomics), metabolites (metabolomics), messenger rna (transcriptomics), etc. in order to safely produce genomic data more quickly, dna sequencing instruments have been moved into our biocontainment laboratories. these methods produce large volumes of data, requiring research and clinical labs to have access to traditional engineering disciplines in data management and analysis. data management is not the only challenge. so far, our descriptions have implied a single host interacting with a single invading pathogenvthe war metaphor. it is not that the metaphor does not work in many cases. for instance, the eradication of smallpox was accomplished through an aggressive worldwide campaign as was the animal and livestock disease rinderpest [ ] . it is that the war metaphor is an oversimplification with an often unrealizable aspiration for victory. consider that most hosts, including bacteria, have associated pathogens and symbiotic microbes. for example, a tropical grass, fungus, and virus have been found to have a three-way symbiosis that confers heat tolerance [ ] . when the virus is removed from the fungus, thermal tolerance is lost by the grass. if the virus is reintroduced to the fungus, thermal tolerance is conferred to the grass. viruses can also integrate their genes into animal genomes as part of the animal's nuclear dna affecting inherited traits [ ] . virus infection is one of several naturally occurring changes in the nucleic acid of a genome. even simple nucleic acid transfers among different biological entities often have difficult to predict results. the complexity compounds as the number of entities increases and community behaviors emerge. for each of the approximately one trillion human cells in our bodies, there are about ten microbes. the microbes are distributed in different, highly specialized, communities in the gut, mouth, skin, etc. collectively referred to as the microbiota [ ] , [ ] . given a global population over billion, there are approximately cells/microbes associated with people on the planet. for comparison, it has fig. . engineering, process, and other controls allow important infectious disease experiments to be conducted safely. representative biosafety level (bsl) labs are shown. bsl- is for agents not known to cause disease in normal, healthy humans. bsl- is for moderate-risk agents that may cause disease of varying severity through ingestion or percutaneous or mucous membrane exposure. bsl- is for agents with a known potential for aerosol transmission and that may cause serious and potentially lethal infections. bsl- is for agents that pose a high individual risk of life-threatening disease resulting from exposure to infectious aerosols, or for agents where the risk of aerosol transmission is unknown. agents appropriate for this level have no vaccine available, and infection resulting from exposure has no treatment other than supportive care. fig. . the global ecosystem is a highly interconnected network of hosts and environments each with its own associated microbiome. nucleic acids, chemicals, and energy are shared within each environment as well as across the global network. new approaches are needed to visualize and understand the relationships among these environments to improve infectious disease management. fitch: engineering a global response to infectious diseases been estimated that there are cells of prochlorococcus bacteria in the ocean [ ] . equally impressive, there are viruses in the ocean causing roughly viral infections every second [ ] . as represented in fig. , whether, grass, animals, or humans, the microbes, the communities, and their host community are sharing chemicals, energy, and nucleic acids. it is no surprise that clinical, animal, environmental, and other samples often have significant genetic complexity. information visualization tools like krona (fig. ) , support analysis of complex metagenomic data [ ] . these types of data can be used to support many applications including investigating food borne disease outbreaks [ ] . genomics helped explain the initiation of the ebola outbreak in sierra leone in [ ] . genomes from virus samples from patients provided evidence that the index case and associated thirteen initial cases in sierra leone had attended the funeral of a traditional healer that had been seeing ebola patients from nearby guinea. the sequence data also showed mutations in parts of the genome that might impact diagnostics, vaccines and therapies. even though the west africa ebola virus disease (evd) epidemic is by far the largest to date, fortunately ''the clinical course of infection and the transmissibility of the virus are similar to those in previous evd outbreaks'' [ ] . the goal is to be able to make these clinically relevant assessments from the virus genome prospectivelyvi.e., before the epidemic provides the observations. computational algorithms and tools are available to find signatures of existing pathogens as well as recognize patterns that help identify previously unidentified pathogens. moving forward, computational models for the interactions among the different genes are needed that provide a context for the correlations in data as well as improve predictive capabilities. for instance, going beyond detecting disease outbreaks to being able to assess and predict disease risks is desired. these much more complicated models offer the potential to accelerate disease understanding and the development and safe utilization of medical interventions at both the individual and the global scales. there are multiple initiatives underway that will lay the foundation and strengthen the underlying science. the foundation will enable new engineering approaches that will achieve the greater goals for infectious disease management. using an approach that parallels the evolution of electrical circuit design and fabrication, the biobricks approach is having increasing impact [ ] . perhaps most famous for its student genetic engineering competition , the biobricks approach of utilizing a library of well-characterized, interconnectable parts is powerful. just as early circuit designers benefited from standards for circuit fabrication, design, interfaces and modules, aspects of biology are amenable to these approaches. not only does the approach provide validation of reductionist concepts of each ''brick,'' but the innovative integration of parts also contributes to the characterization and future sharing of more complicated parts. just as circuit designers can incorporate existing designs or entire functional units like memory or analog to digital conversion, biologists are increasingly able to import others' designs and achieve significantly more functionality. for instance, a rewritable digital memory system has been demonstrated that writes and rewrites nucleic acid bases in a chromosome [ ] . just as dna sequencing brought a methods-based structure to pathogen detection, approaches like biobricks bring structure to biological circuits. the electronic circuit analogy continues with the opportunity for software to facilitate design and accelerate testing and evaluation. just as in our early example for influenza vaccine development, the components of the biobricks approach are amenable to spiral engineering for both performance and cost. building computer architectures and software that can implement ab initio test and evaluation calculations for infectious disease trials would require significant advances in algorithms, capabilities, and fundamental biochemical data. while exciting progress is being made in these areas, an alternative approach is to consider the network of interactions among fundamental building blocks and identify correlations with disease and health. this is the domain of systems biology and the building blocks can include dna, rna, and peptides. progress in systems biology is often paced by access to appropriately curated and calibrated datavnot just the underlying nucleic acid content but the associated metadata that describe the host and the relevant associated microbial communities. one of the multiple approaches to address data needed is the hundred person wellness project of the institute for systems biology. this project is measuring multiple indicators of health over a nine month period and will include lifestyle coaching as part of the study [ ] . if successful, the project already has plans to scale to a thousand and then thousand participants. there are similar concepts underway at organizations as diverse as google x and human longevity. even though these studies do not focus on infectious diseases, they are of significant value in helping to define the baselines for ''normal'' at different ages, genders, and many other variations that may affect health. infectious disease is a global issue that remains a significant cause of death and economic impact. engineers and engineering have many opportunities to help mitigate these diseases ranging from using cell tower power to help deliver vaccines to providing new network analysis software to identify novel viruses in an outbreak. the joint evolution of engineering and life sciences brings expanded availability and opportunity to understand and design living systems. these are attributes that will be needed to address the medical and infrastructure needs for effective global infectious disease management. however, the zeal to innovate needs to be mediated by a culture of responsibility [ ] where the benefits and the risks are considered. the ieee code of conduct [ ] is consistent with this ethos and addresses quality of life and privacy topics that have been discussed in this paper. engineers have an opportunity to provide innovative application of existing infrastructure to infectious disease management and to help nurture a global culture of responsibility in both healthcare and technical applications. h global health estimates summary tables: deaths by cause, age, and sex antimicrobial resistance: tackling a crisis for the health and wealth of nations enhancing the research, mitigating the effects ending the war metaphor: the changing agenda for unraveling the host-microbe relationship detection of the middle east respiratory syndrome coronavirus genome in air sample originating from a camel barn owned by an infected patient. mbio learning from sars: preparing for the next disease outbreak emerging infectious diseases: threats to human health and global stability available: http:// 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surveillance systems: a systematic review. epidemiology infection report to congress: update on the adoption of health information technology and related efforts to facilitate the electronic use and exchange of health information the office of the national coordinator for health information technology, food and drug administration and federal communications commission building safer systems for better care global infectious disease surveillance and health intelligence: the development of effective, interconnected systems of infectious disease surveillance is essential to our survival nyc health alert network putting public health into practice: a model for assessing the relationship between local health departments and practicing physicians ( s ), pp. s -s interpreting the universal phylogenetic tree genomic engineering: moving beyond dna sequence to function the rise of a digital immune system. gigascience department of health and human services oie world organization for animal health a virus in a fungus in a plant: three-way symbiosis required for thermal tolerance endogenous viral elements in animal genomes human microbiota human microbiome project present and future global distributions of the marine cyanobacteria prochlorococcus and synechococcus marine virusesvmajor players in the global ecosystem interactive metagenomic visualization in a web browser whole-genome sequencing expected to revolutionize outbreak investigations. food safety news genomic surveillance elucidates ebola virus origin and transmission during the outbreak the who ebola response teamonline. ebola virus disease in west africavthe first months of the epidemic and forward projections rewrittable digital data storage in live cells via engineered control of recombination directionality medicine gets up close and personal guidance for enhancing personnel reliability and strengthening the culture of responsibility the author thanks dr. k. bernard for his suggestion to consider the broader utility of pandemic influenza plans to other diseases, dr. n. bergman for his valuable suggestions and comments, and ms. c. conrad for her expert assistance preparing the manuscript. key: cord- -jckfzaf authors: walsh, patrick f. title: intelligence and stakeholders date: - - journal: intelligence, biosecurity and bioterrorism doi: . / - - - - _ sha: doc_id: cord_uid: jckfzaf this chapter underscores the need for more explicit and strategic engagement of stakeholders (scientists, clinicians, first responders, amongst others) by the intelligence community. the chapter argues that the intelligence community will increasingly rely on their expertise to build more valid and reliable assessments of emerging bio-threats and risks. however, the discussion also identifies some of the limitations and challenges stakeholders themselves have to understanding complex threats and risks. agricultural scientists and veterinarians) can all be critical stakeholders for intelligence communities. without them it would be almost impossible to see how the ic alone can fulfil its mission to identify, prevent, disrupt and treat potential and emerging bio-threats and risks. indeed as seen in chapter 'the scientific community' brings a lot of expertise to the intelligence community about how to assess bio-threats and risks in a number of different ways and contexts. these include understanding potential risks through gof experiments, the development of biosensors and knowledge about weaponisation, pathogenicity and transmissibility of various bio-agents. chapter also surveyed briefly the role of scientists working in epidemiology and forensics as providing central roles in the prevention, disruption and treatment of bio-threats and risks. additionally, chapter , highlighted the critical role the scientific community plays in helping the intelligence community better frame their understanding of potential threats and risks emerging from the fast paced changing biotechnology and synthetic biology sectors. this chapter provides a thematic analysis of how important stakeholders can contribute to reducing current and emerging bio-threats and risks. in contrast to chapter , which focused on what internally the intelligence community can do to better equip itself to manage bio-threats and risks, this chapter surveys what important external stakeholders can bring to the table to improve intelligence capability and to reduce bio-threats and risks themselves. paraphrasing research impact scholar mark reed's definition, i define a stakeholder of the intelligence community as any person, organisation or group that is affected by or can affect a decision, action or issue relevant to preventing, disrupting or treating bio-threats and risks (reed : ) . specifically, i am referring to stakeholders in the scientific, research, clinical, policy, first responder and private sectors that can provide capability, expertise to the intelligence community and/ or contribute to biosecurity through their own actions. in particular, the thematic analysis of the role of stakeholders in this chapter is organised around three sub-headings: prevention, disruption and treatment. traversing the literature and interviews with a select number of stakeholders shows there that there is a large and diverse number of individuals and organisations that could potentially play a role in either preventing, disrupting or treating future bio-threats and in the biological context, surveillance is the ongoing collection, analysis, and interpretation of data to help monitor for pathogens in plants, animals, and humans; food; and the environment. the general aim of surveillance is to help develop policy, guide mission priorities, and provide assurance of the prevention and control of disease. in recent years, as concerns about consequences of a catastrophic biological attack or emerging infectious diseases grew, the term bio surveillance became more common in relation to an array of threats to our national security. bio surveillance is concerned with two things: ( ) reducing, as much as possible, the time it takes to recognize and characterize biological events with potentially catastrophic consequences and ( ) providing situational awareness-that is, information that signals an event might be occurring, information about what those signals mean, and information about how events will likely unfold in the near future (gao : ). this definition highlights how the functions and roles of biosurveillance has changed from a more narrow concern of mapping disease in the public health sector to represent a diverse array of knowledge and capabilities that are vital in understanding bio-threats in the national security context. the definition also underscores the ongoing multiple challenges in improving bio-surveillance capabilities and their utility in the national security context. three key challenges in particular remain for improving national bio-surveillance capabilities and they are: methodological, information sharing and integration issues. the information sharing and integration issues have already been discussed in chapter so this section will focus on the bio-surveillance methodology issues. by methodological issues, i am referring to both the technical methods (biosensors) and the broader different disciplinary approaches to biosurveillance that now inform debates amongst stakeholders on how to improve bio-surveillance capabilities. from a technical perspective, there has been a range of bio-sensor research from inside and outside the ic to detect the release of dangerous pathogens into the environment. perhaps the most well-known of these initiatives-biowatch was developed by dhs in with the aim to detect aerolised bio attacks for high risk bioagents in major us cities. the program however, has had mixed success relating to the reliability of results and the delay in the publication of these once samples were collected from the field (gao (gao , . the dhs tried to speed up the detection times from the first generation manual systems to gen acquisitions, which promised speedier autonomous systems though testing difficulties remained. further analysis, however, of alternatives by the dhs as showing any advantages of an autonomous system over the current manual system were insufficient to justify the cost of a fully technology switch (gao : ) . in the us, research continues to improve the robustness, sensitivity, specificity, timeliness and cost of biosensor equipment. while conventional pcr based methods and immunoassay are still being used other biochemical, microbiological and genetic solutions are being trialled such as the incorporation of antibodies and peptide molecules, which may greatly reduce detection times to minutes instead of several hours (kim et al. ) . leaving aside efforts to improve aerolised biosensors, the expected rapid growth of synthetic biology and biotechnology and the potential (however unknown) that bioengineered material may be used maliciously in a way that threatens public safety or national security may shift the focus into other scientific research that can detect signals of bio-engineering including types of changes, location and possibly in the future where changes were made. in july , iarpa commissioned a new program-finding engineering linked indicators (felix) to meet such objectives. iarpa is seeking interest from a range of scientists (synthetic biologists, micro biologist, immunologist, statisticians and computer scientists) to carry out - research projects addressing the two main focus points of felix (eaves ) . if this research can produce reliable results, it will provide another useful collection and analysis point for the ic by allowing the detection of previously undetectable signatures of bio-engineered material in bio-criminal and terrorism cases. in addition to the various technical innovations in biosensors, a range of other bio-surveillance methods have been deployed. in the late s, the us cdc pioneered syndromic surveillance systems, which were initially aimed at improving the early warning of infectious diseases and bio-terrorism and have now evolved to include situational awareness (buehler et al. ) . similar syndromic surveillance systems have developed in other 'five eyes' countries such as the uk's real-time syndromic surveillance team (resst), which collects four national syndromic surveillance systems from several sources. additionally and more recently, the robert koch institute is creating an early warning system based on machine learning and natural language processing that will include 'appealing' interactive web applications and be linked to the german electronic reporting and information system demis (robert koch institute ). syndromic surveillance systems are a critical adjunct to traditional public health lab surveillance as they strive to provide real time or near real time collection, analysis and dissemination of health data to enable early identification and management of public health threats as they are not based on lab confirmed diagnoses-and assess a wider set of health related data including: clinical signs, absenteeism, pharmacy sales or animal health production collapse (buehler ) . a clear benefit of syndromic surveillance is it can be cheaper, faster and potentially more transparent then a state's public health lab surveillance system. however, as with the use of big volumes of data more broadly in the ic, data quantity, quality and structural variation all impact on the utility, accuracy and timeliness of some rapid epidemic intelligence from internet based surveillance methods (yan et al. ) . increasingly these syndromic surveillance systems rely on the use of big data, machine learning and analytics. additionally, web based epidemic detection systems like biocaster portal developed by the national institute of informatics in tokyo (collier ) and canada's global public health intelligence network (gphin) an event based surveillance system which looks at news feeds globally have also contributed to syndromic surveillance systems (mawudeku et al. ) . several event based internet surveillance systems have grown in number in the last decade. using pubmed, scopus and google scholar data bases, o'shea's study found based internet systems all using different technology and data sources to gather data, process and disseminate it to detect infectious disease outbreaks (o'shea ). in line with the broader ic development of exploiting social media analytics discussed in chapter , in dhs piloted another approach to bio-surveillance. the pilot involved dhs trialling various social media analytics from self-reported information on facebook and twitter to determine pandemics and acts of terrorism given social media feeds can provide close to real time reporting of symptoms, sickness access to hospital or pharmaceuticals (insinna ) . additionally, other private companies have entered the biosurveillance space-providing novel methods for capturing bio-surveillance data. wilson's discussion of how a private company (veratect corporation) assessed signal recognition in global media reports to provide warning on the emergence of the h n influenza pandemic shows how the ic warning culture methodology can be employed usefully along with what he described as the 'risk adverse forensically oriented response culture favoured by traditional public health practitioners' (wilson : ) . the veratect case shows that the private sector has a role in developing better bio-surveillance capability as well. as can be seen from the brief discussion above about different methodological approaches to bio-surveillance. there are also different views amongst bio-surveillance scholars and practitioners about the merits of each, particularly in their abilities to predict the 'next pandemic'. can for example, a national bio-surveillance system informed by one or more methods discussed above predict the emergence of the next pandemic or outbreak, particularly novel new viruses? some scientists argue that the prediction of a micro-evolutionary process of some biological agents such as a virus (i.e. a short term emergence or cross species transition) is incredibly difficult given evolutionary and epidemiological timescales are fundamentally different. geoghegan and holmes argue that instead it would be better to build surveillance capability that 'assesses the fault line of disease emergence at the human-animal interface, particularly those shaped by ecological disturbances' ( : ). others have argued differently. scientists working on the usaid funded predict and the global virome project examine disease hotspots globally in order to sequence (rather ambitiously) almost all the viruses in birds and mammals that could potentially spill over into humans. in particular, researchers working on the global virome project believe that prediction of which viruses might spill over from animal to human health is possible. geoghegan and holmes in response argue focusing on disease hotspots relies on very small amounts of data that can be unreliable given they are rare events. they give the example of saudi arabia which has not classically been a hotspot, yet mers recently jumped into humans from camels there. sequencing these viruses may provide useful evolutionary information, but geoghegan and holmes argue it won't necessarily provide early warning of what is going to affect us (geoghegan and holmes ) . other scientists are trying to change the ecology of disease, which presumably in some cases would make the early warning of some pandemics easier. in recent years, the scientific community has increasingly exploited crispr gene editing techniques to change the genetic makeup of malaria mosquitoes. additionally, advances in gene drives have recently been shown to change the ecological parameters of disease. gene drives are artificial 'selfish' genes that can force itself into % of an organism's offspring instead of the usual %. currently there is a global research effort funded by the gates foundation to cause female mosquitoes to become sterile within generations or year. the objective would be to release the genetically altered mosquitoes into malarial areas by (regalado ) . there are concerns by the fbi however that gene drives could be misused to create a 'designer plague' (ibid.). in addition to the 'predictability' challenges presented by various bio-surveillance methods, there are also differences in opinion amongst members of the bio-surveillance community about what an effective bio-surveillance system looks like. on what metrics can an 'effective bio-surveillance' system be evaluated given the multiple methodological approaches and systems that have developed for bio-surveillance? clinician and public health security specialist jim wilson has argued that the development of an effective global surveillance and response system is probably at least a decade or more away (wilson : ) . in the interim, we are left with multiple approaches of varying validity and reliability. so based on the current fragmented bio-surveillance efforts how do we learn the lessons that need to be learnt that will enable the implementation of the long awaited national bio-surveillance capabilities? how do we know if progress is being made to that goal? importantly, beyond national efforts, how do we assess the current capability of state, local agencies to contribute to a national bio-surveillance capabilities? where are the gaps and vulnerabilities in the current sub-national bio-surveillance and detection systems? (gao ) . compounding the current challenge of evaluating bio-surveillance capabilities in order to construct a viable national approach is that different bio-surveillance systems have been created for different end users (e.g. animal and human). the blue ribbon project report into animal health detailed information sharing challenges in animal health bio-surveillance and its integration with other bio-surveillance data including in human health (blue ribbon report : ) . this lack of integration makes it difficult to assess how information collected for animal or agricultural bio-surveillance could improve national approaches to bio-surveillance, particularly in scenarios where the emergence of disease could be an intentional or a malevolent act. different approaches to bio-surveillance have been informed by multi-disciplinary perspectives, which can be both a strength and weakness to developing a national perspective. current efforts across the 'five eyes' to develop fully national and integrated bio-surveillance capabilities remain works in progress and the political will to steward them into being seems insufficient. for example, in the us a program designed to provide a national bio-surveillance and integration system was eliminated in the president's budget request for fy (blue ribbon report : ). any evaluation of the effectiveness of various methods and approaches for building a national bio-surveillance capability also needs to consider how national efforts can both enhance and lever off global bio-surveillance capabilities. gaps and impediments in global biosurveillance have become increasingly evident to the world in the wake of the largest ebola epidemic ever-in which these challenges impacted the ability to prevent, detect, and respond. under the looming threat of mers-cov, leishmaniasis, influenza, multidrug-resistant tuberculosis, and plague, the global public health community now realizes the urgent need to address shortcomings in global bio-surveillance and the broader public health security system. properly preparing for the next major outbreak hinges on our willingness to transform global health surveillance systems and those of countries with fragile health infrastructures (shaikh et al. : - ) . in some respects, similar challenges in developing national bio-surveillance capabilities exist in those at the global level including: siloed systems, inadequate training and technical expertise, different information and communication technology (ict) standards, concerns over data sharing and confidentiality, poor interoperability, and inadequate analytical approaches and tools. there is likely not one bio-surveillance method, technique or tool that is going to detect in real time disease outbreaks, particularly unusual ones which might imply malicious intent. a fully integrated approach to bio-surveillance may rely on more than one method or capability which together can provide reliable and valid bio-surveillance data and early warning at the national and global level. it may mean investigating ways that older legacy systems can be integrated or at least made interoperable with newer more mobile platforms such as mobile or wireless health technologies particularly in the developing world (shaikh et al. ) . it should be clear by now that improving bio-surveillance capabilities is essential to improving the prevention of natural and suspicious outbreaks of disease. it is important for the 'five eyes' intelligence and law enforcement communities to understand broadly the theoretical and practical developments in bio-surveillance so that they are able to more effectively lever relevant knowledge on bio-threats and risks. a second cluster of stakeholders that are useful in the prevention of bio-threats and risks (both natural and malicious) are those working in national, regional and global health. the ebola epidemic ( ) ( ) was a recent reminder of the consequences of weak public health capability and infrastructure in failing to prevent, identify and respond quickly to infectious disease. the ebola epidemic also had a catalytic effect on many public health authorities, practitioners and researcher's views about the capability of the traditional un response to global health crisis mainly coordinated through the who. many public health watchers are now arguing the need for a broader more effective focus-not just on prevention and response to infectious disease, but one that also included reframing the focus as a human security issue. adherents to this view make a compelling point when seen through the ebola case that continues to have significant impact on the economic and social stability of countries impacted (sparrow ; marston et al. ; who ; mmwr ) . beyond west africa, similar vulnerabilities in capabilities such as diseases surveillance, detection, contract tracing, clinical care, community engagement and communications exist globally as was also seen with the proliferation of zika in latin american/caribbean and mers in the middle east. in , the commission on a global health risk framework for the future that met after the ebola crisis estimated . billion per year investment would be needed for better detection and response tools. the same commission report also estimated that the economic cost for global pandemics per year was $ billion (schnirring ; dzau and sands ) . effective national bio-surveillance relies on not only what 'five eyes' countries can do to improve the scientific and technical capability of bio-surveillance, but also how they can improve bio-surveillance globally particularly in at risk areas. beyond effective bio-surveillance, effective prevention of pandemics whether natural, accidental or malicious relies on good global (multilateral), regional and national public health responses. there are several multilateral instruments, institutions and initiatives that are relevant, but i will focus here on what have become the key ones rather than attempting to traverse in detail all major international health initiatives struck since / . they include who international health regulations (ihr), un security resolution , the global health security agenda (ghsa), the biological weapons convention (bwc) and the australia group. the who international health regulations ( ) entered into force in june to prevent, protect against, control and provide a public health response to the international spread of diseases (detect, assess, notify events has a biosafety and biosecurity function) and includes all members of the un. the ihr has improved accountability of countries about progress towards building national core public health capability targets in several areas including, but not limited to: surveillance systems, creating rapid response teams, border management. however, the ihr annual reporting process has been by self-assessment of core capacities to the world health assembly (wha) by all state parties, which has resulted in incomplete or not credible reporting for some member states. the commission on global health risk framework for the future also expressed concerns over the self-assessment monitoring tool of the ihr, because questions are binary (yes/no) answers and recommended that who devise a regular independent mechanism to evaluate country performance against benchmarks (ghrf commission : ). for example, a country can 'tick yes' for having a national public health legislation, but other dependent legislation (biosecurity, food safety, environmental health) may not be in place-thereby reducing overall the country's ability to manage health crisis or for the global community to understand and respond to capability and information gaps in that country (ibid.). some countries continue to be slow or uneven in their reporting of ihr ( ) attributes. in , one study showed that the african region was well below global averages across all attributes measures with no african state reporting full implementation (kasolo et al. : - ) . the second multilateral instrument relevant to our discussion here is the un security council resolution ( , which calls on all states to prohibit non-state actors from developing, acquiring, manufacturing, possessing, transporting, transferring or using nuclear, chemical or biological weapons and their delivery systems. more importantly and specific to bio-threats only, the bwc has historically played the most significant role in preventing the weaponisation of biology. the bwc was established in and seeks to prohibit the development, production, acquisition, transfer, stockpiling and use of biological and toxin weapons (gerstein ; chevrier and spelling : - ) . in , there was an attempt by some member states to introduce a verification process, but this was vetoed by the us following inspection of soviet sites under the tripartite agreement between the soviet union, usa and the uk. the us arguing it could be difficult to certify that a state's biological program was merely defensive rather than offensive. the us also had concerns that inspection to labs could be disruptive or provide opportunity for industrial espionage against legitimately operating biotechnology companies (gerstein : ) . historically there has been a mixed record by some 'five eyes' intelligence countries in assessing verification and therefore noncompliance of the bwc. koblentz surveyed the role of intelligence (particularly humint) in assessing the former soviet union's offensive bio-weapons program between and which resulted in an incomplete picture of moscow's program (koblentz : ) . additionally, as discussed in chapter , in several 'five eyes' intelligence communities (us, uk and australia) incorrectly assessed that iraq had a mobile offensive bio-weapon capability. intelligence collection on its own can either over or under-estimate such capabilities. between yearly review conferences, several initiatives and activities have been introduced (confidence building measure, meetings of experts, information exchanges) to improve the effectiveness and the implementation of the convention. however, state parties are only encouraged to implement relevant national legislation and other measures to prohibit prevent the development, production, stockpiling or transfer or use of bio weapons. how they precisely undertake measures is at the discretion of individual state parties. the bwc has been criticised for several reasons over the years. some of this is warranted, while other criticisms seem to not take into account that the bwc is different from its chemical and nuclear counter proliferation counterparts. as gerstein argues, 'material is the centre of gravity for nuclear discussions and intent being the center of gravity for biological issues' (gerstein : ) . developing nuclear weapons leaves a large recognizable footprint, whereas the development of an offensive biological weapon requires virtually no specialised equipment (ibid.). the first major criticism of the bwc is that it has no verification mechanism or any other mandatory provisions for monitoring compliance. a second complaint is that for many years (until ) , it lacked an implementation capability to help states fulfil their obligations. since , the convention has had a small three team implementation support unit (isu) based in the united nations office for disarmament affairs in geneva which aims to 'assist, coordinate, and magnify the implementation efforts of the states parties to help states parties help themselves' (lennane : ) . in reality though, the isu does not have 'capacity for analysis and coordination other than for the collection of the annually submitted confidence building measures, posting them to the website and organising and attending conferences' (gerstein : ) . historically there has also been a low number of party states submitting their annual confidence building measures. although the bwc isu was able to report that a record number ( ) annual confidence building measures were submitted in , this only represented . % of all state parties submitting that year. though the trend line seems to be going up from a low in of (bwc newsletter : ). a third criticism of the bwc is that it has moved slowly since inception and further questions remain about its relevance strategically and operationally in preventing bio-threats and risks into the future. such questions are likely fundamental to its long term viability. however despite shortcomings, the bwc has nonetheless created a normative institution for reducing the risk of biological or toxin weapons being used or developed by state and non-state actors (lennane : ) . more importantly, as developments in biotechnology continue at a pace, the bwc does provide a venue, where the security implications of dual-use technology can be assessed which will be critical in 'mitigating these emerging threats' (gerstein : ) . the bwc still does have an important role in reducing weaponisation of biology in the future, though its poor funding particularly of the isu means that other multi-lateral measures are needed to amplify the work of the convention. in addition to the above historic/traditional proliferation arrangements of the bwc, other international regimes have been implemented such as the australia group (established in ) and the proliferation security initiative (established in ). both have a broader counter proliferation objectives beyond biological weapons to chemical and nuclear. the australia group member countries have collaborated on the development of lists of technologies and materials that could be used in the development of chemical and biological weapons. member countries then commit to monitor the export or transfer of these materials. the australia group maintains common control lists for dual use bio-equipment, technology, software, bio agents and plant and animal pathogens as the basis for promoting common standards and regulations (australia group common control list handbook ). the australia group works in concert with the bwc. the psi was a bush administration initiative that sought to supplement existing non-proliferation regimes, but seeks to enforce these by interdicting and seizing illegal weapons or missile technology in planes or ships carrying cargo. the psi also includes intelligence sharing and joint operational activity (national institute for public policy ). turning the focus slightly away from multi-lateral counter proliferation measures, other multilateral initiatives have focused on improving global health security. in some respects the ghsa provides a bridge between traditional, narrow security approaches to biological weapons and a wider securitisation of global health. the ghsa was established in by the obama administration and is a multi-sectoral approach to global health security seeking to include governments, international organisations and non-government organisations. ghsa was set up in part to 'advance further the ihr implementation through focused activities to strengthen core capacities and to ensure a world safe and secure from global health threats posed by infectious disease; where we can prevent or mitigate the impact of naturally occurring outbreak and intentional or accidental releases of dangerous pathogens' (heymann et al. (heymann et al. : . ghsa is a refreshing approach not only because it seeks to establish a global framework and capacity to assess, measure and sustain advances in global preparedness for epidemic threats, but it also addresses biosecurity as a public health priority-thereby linking public health and health security, development, defense and agricultural sector (cameron ) . the underlining logic of ghsa suggests that the same attributes needed to prevent, detect and respond to deliberate use of a bio agent are those required to manage a natural or accidental outbreak of a biological agent. ghsa also includes technical targets aligned to three areas: prevention, detection and response (heymann et al. (heymann et al. : . like earlier initiatives, such as the us sponsored global health initiative (ghi), which was discontinued by the obama administration in due a lack of financial and technical authority to leverage and coordinate multiple us agencies-the ghsa will need to secure ongoing funding beyond from major donors including the us. at a november ghsa ministerial meeting in uganda, assembled governments signed onto an extension of the ghsa for another five years. us secretary tillerson had issued public support for continuing it, but at the time of writing no commitment by the us for future financial support (beyond fy ) has been made. ghsa holds promise, but in addition to ongoing funding challenges, those member states signed up to it will need to ensure effective governance is in place to align funding to global health priorities articulated by the who, world bank, imf and other donors in order to avoid duplication and promote an effective approach to international health security capabilities (paranjape and franz ; . in summary, this discussion of multilateral security and global health initiatives demonstrates that there is a diverse number of stakeholders working in these sectors, which can play a role in preventing biothreats and risks-whether they are natural pandemics or a malicious attack from a biological weapon. it's clear that the 'five eyes' intelligence communities have worked extensively with other member states in counter-proliferation institutions such as the bwc and the australia group for several decades, but what remains still under developed is how global health security stakeholders and intelligence communities can work more collaboratively for the mutual goal of global health security regardless of whether the risks are natural pandemics or result from a bio-terror attack or theft of a dangerous select agent from a lab. more trusting and formalised contact between both global health security stakeholders and those working in the security and intelligence communities can only be mutually beneficial to preventing major bio-threats and risks. the final cluster of stakeholders that can help prevent bio-threats and risks are of course those that specialise in biosafety and its promotion in their research institutes, biotechnology companies, universities and medical facilities. promoting biosafety in environments that work with select agents and other facilities that work with less dangerous material which can still cause harm relies on consistently high risk management practices. in all 'five eyes' countries there has historically been in place biosafety risk management procedures and practices to prevent accidental infection, accidental release, or intentional misuse of biological substances. however, as noted in chapter in the last two decades the expansion in synthetic biology, biotechnology and biological science research has meant there are now more people working in more locations on dangerous pathogens-not just in well-regulated liberal democracies such as those in the 'five eyes' countries, but also in developing countries; where biosafety and biosecurity capabilities and practice may be less established such as parts of africa, the middle east, pakistan and former soviet states (gronvall et al. ; shinwari et al. ) . just in terms of the scale of this expansion of facilities working with dangerous pathogens-in the us alone, there is thought to be thousands of bsl labs and in china the number of such labs is increasing too (nature editorial : ). the us and other 'five eyes' countries such as canada have invested in cooperative engagement programs since / in several former soviet union states. the us defense threat reduction agency (dtra) has lead efforts in georgia to reduce bio-risk by securing/consolidating pathogens, training scientists in biosafety and biosecurity technology, regulation and detection. likewise, the cdc has been involved in building public health capacity there as well as in armenia and azerbaijan (bakanidze et al. : ) . as important as building biosafety capacity is in developing countries, it is clear that much more still needs to be done to build biosafety capacity in 'five eyes' countries-including finding better ways to understand and manage comprehensively threats and risks in the biosciences environment. biosafety experts such as salerno and gaudioso argue for more comprehensive risk management systems across the global bioscience community 'to avoid an accident that jeopardizes the entire bioscience enterprise' (salerno and gaudioso : xv) . their argument is that such a system would supplement existing national and international biosafety regulations by risk managing fully at an organisational and unit level every single potential incident rather than by generic risk hazard assessments that are currently done by most facilities today (ibid.: ). others have also called for more systematic tools and approaches for managing biosafety incidents in labs dealing with particular dangerous pathogens such as marburg virus (dickmann et al. ) . still others have argued that while 'security awareness is high among employees who work with biological select agents and toxins, it is not pervasive across the entire life research community' (grphyon scientific : . such a statement does not seem to be hyperbole if one looks at some of the cases of biosafety and security lapses since / (gao (gao , . there have been several lapses at cdc between and . in june , dozens of workers in cdc could have been potentially exposed to live anthrax that hadn't been killed before being shipped from cdc's bioterrorism rapid response and advanced technology (brrat) bsl to a bsl lab in its bacterial special pathogens branch. cdc investigations determined that at least cdc staff members may have been exposed to viable anthrax cells or spores though no illness or deaths occurred (cdc ). the same report found several breaches of biosafety process and procedure including failures of policy, training, supervision, judgement and even scientific knowledge (ibid.). similarly, biosafety lapses cases involving cdc labs occurred in january when an unintentional cross contamination strain of low pathogenic avian influenza a (h n ) with a strain of highly pathogenic avian influenza a (h n ) was shipped from cdc to the usda (schnirring ) . further biosafety breaches were detected in july -this time at the national institute of health campus in bethesda maryland; where viable smallpox vials were discovered improperly stored (dennis and sun a ). an additional five improperly stored vials were also found at the nih-three were select agents (burkholderia pseudmomallei, francisella tularensis and yersinia pestis ) (dennis and sun b). in the nih cases despite their age, they were still viable organisms which could have caused illness. their theft could have also posed a bio-threat and risk to the community. then after a hiatus where biological material was suspended being sent between bsl and bsl labs live transfers commenced again. after a further internal cdc review (cdc a, b) some additional safety measures were put into place, however there was a subsequent lapse when a specimen of chikungunya virus was shipped from a high secure lab in fort collins to a lower level one which had not been killed (young ) . similarly, in the pentagon shipped live anthrax spores from the dugway proving ground in utah to states and one international location that were also meant to have been killed (burns ) . it was later found that dugway and the us dod had been shipping nationally and internationally live anthrax for more than years-often without adequate safeguards. other reports suggested that some samples were sent by federal express (sisk ) . similarly in november , the us hhs discovered that a private lab had 'inadvertently sent a toxic form of ricin to one of its training centres multiple times since putting training staff at risk' (gao : ). similar biosafety lapses have occurred in the uk resulting in investigations since of government, university and hospital labs (sample ) . as noted in chapter , one possible bio-threat and risk pathway could be the theft of biological substances or information from a biosciences institution. lapses in biosafety arrangements demonstrate, at least in some cases, biosecurity vulnerabilities that could make the theft or even infiltration of a threat actor into high containment lab easier. thefts from labs have occurred in the past by an insider, and a motivated insider can compromise biosafety for a range of reasons. bunn and sagan's edited book insider threats provides a useful taxonomy for thinking about 'insider threats' (bunn and sagan ). they can be: self-motivated insiders, who at some point decide to become a spy or thief. insiders can also be recruited insiders, who are already inside an organisation, but become convinced to become part of a plot. finally, an infiltrated insider might be associated with some adversary of the organisation and join it with the purpose of carrying out a malicious act against it. bunn and sagan also refer to inadvertent or non-malicious actors, who pose a threat by making mistakes without really intending to do so-such as leaving a password lying around. finally, the authors refer to a 'coerced insider', who remains loyal in intent, but knowingly assists in theft or sabotage to prevent hostile acts against themselves or their loved ones (ibid.: ). the insider threat that was posed by bruce ivins' activities in a high containment lab (that resulted in amerithrax in ) demonstrates the potentially high threat and risks associated with an insider. the ivins case provides a useful case study in how an organisation's security procedures and other organisational and cognitive biases can miss for several years risks posed by an insider threat actor (stern and schouten : - ) . since the amerithrax incident, significant investment has been made to close the biosafety vulnerabilities revealed by it. increasingly since / and amerithrax, a number of policies, procedures and normative behaviour have developed in the scientific community to promote biosafety and biosecurity. these have ranged from safety regulation codes such as the us biosafety in microbiological and biomedical laboratories (bmbl ) to more formal legislative and oversight regulations. the latter will be addressed in chapter . there are also technical and policy improvements that can be made in securing both physical and remote access to labs including computer systems that house data, which are at risk of theft or being hacked (gryphon scientific : berger : - ; slayton et al. : - ) . leaving aside discussion of some of the formal legislative and regulatory instruments for promoting biosafety, the development and maintenance of effective risk management across the biosciences also relies on an organisational culture that treats biosafety and biosafety as an equal priority to other deliverables. a culture of accountability at all levels must also exist if effective risk management can prevent, identify and treat bio-threats and risks promptly. a rogue insider threat, who may have been assessed as appropriate to work with select agents and seems initially to follow all the relevant biosafety regulations and procedures could still pose a risk if they have not embraced the organisation's normative cultural biosafety values. it is critical then in order to stop opportunities for insider threats, that the organisation promote relevant biosafety cultural values as much as and perhaps more than adherence to formal biosafety regulations. risk management measures must of course be measured against the ability of scientists to carry out its functions. effective engagement with local law enforcement and relevant domestic security intelligence organisations in each 'five eyes' country to help scientists build viable biosafety cultures will likely remain important in addition to internal organisation biosafety initiatives. stern and schouten provide a number of useful suggestions for improving policies and procedures that may help improve biosafety cultures across the biosciences enterprise ( : - ). two that i think would be helpful are, one: developing standard operating procedures for proactively identifying vulnerabilities including using 'red team' exercises to explore how systems could become exploited. in other words, what motivators (financial, psychological, religious, and political) might drive an insider threat and are there ways to assess the signs of such an evolving threat? the other is to 'ensure personnel reliability programs incorporate ongoing assessments of counterintelligence vulnerabilities, including vulnerabilities to self-ascribed whistle-blowers or attention seekers' (ibid.: ). effective biosafety and biosecurity training is also crucial as the number of labs working with select agents or other dual use bio-agents proliferate globally, particularly in locations with fragile states. more consistent approaches to training will also be important so nations can be confident that as many scientists as possible regardless of the country or the context in which they work understand what bio-risks and threats may emerge and how to prevent or mitigate against them (sture et al. ). as discussed above there are multiple stakeholders in the scientific community, global health security and biosafety fields that can play a critical role themselves in preventing bio-threats and risks as well as supporting the operational efforts of the intelligence community to prevent these. while prevention of bio-threats and risks is one critical dimension that stakeholders can play central roles another is disruption. although the intelligence community can use a range of knowledge, technologies and methodologies from stakeholders in the scientific community, to prevent bio-threats and risks, we have to accept that it will not be possible to detect every criminal or terrorist act. nonetheless, some of the techniques, practices, technologies and knowledge available from stakeholders in the scientific community will still be useful to disrupting bio-threats and risks. in other words prevention may not always be possible yet measures can be put into placewhich can detect threats early enough to reduce their impact. similar to preventing bio-threats and risks, disrupting them will also rely on seeking advice from stakeholders involved in bio-surveillance, public health and biosafety research, amongst others on disrupting them as well. for example, as discussed earlier iarpa's commissioning of research into detecting signals of bioengineering changes (felix) may result in better capability for the intelligence community in not only preventing bioengineering changes that make it easier for terrorists to carry out attacks on populations, critical infrastructure or biotechnology companies, it could also help detect and disrupt the planning stages for such attacks. additionally as noted earlier, if a high containment lab has a strong biosafety culture it is more likely that disruption of a biothreat may be possible just by colleagues speaking up about suspicious activities in their working environment rather than any elaborate disruption knowledge and techniques, procedures the intelligence community might have in place to disrupt such threats. but knowledge, technologies, techniques and practice for disruption of bio-threats and risks cannot just come from scientific stakeholders in the biosciences, it should also come from other fields and practitioners working in other areas where successful disruption operations has taken place. these areas include criminology, policing, engineering, legislation, cyber, counter-intelligence amongst others. in this section, we examine briefly what other stakeholders and discipline perspectives might the intelligence community learn from that can provide better capabilities for the disruption of bio-threats and risks. are there lessons to be learnt from other stakeholders, disciplines or even other threat contexts that might be relevant to disrupting biothreats that might not have been initially detected? since / , there are three stakeholder and discipline groups, which are investigating and applying disruption strategies to threats and risks and their knowledge might be relevant in disrupting threats and risks in the bio context. these are criminology, counter-terrorism and cyber. we will explore each briefly to see how stakeholders (researchers and practitioners) have developed disruption strategies in each and how they might be employed against bio-threats and risks. insights from criminology and the practical application of disruption for crime prevention has provided a supplementary approach to traditional law enforcement approaches of prosecution against certain crimes through the courts. disruption is not a new concept in criminology and law enforcement practice, though it can be difficult to define in all law enforcement contexts (ratcliffe : ) . its meaning at least in the criminology/policing/law enforcement contexts can partly be traced back to broader desires-initially by uk law enforcement followed later by other 'five eyes' countries in the late s and early s to move law enforcement away from its traditional reactive mode to offending to one driven by intelligence. this concept of law enforcement or policing being intelligence driven or led gained significant traction in the criminology and policing literature (walsh ; ratcliffe ; innes and sheptycki ) . it was driven initially in the uk by the desire for governments to maximise efficiencies and reducing costs by increasing the use of intelligence to drive strategic and operational decision-making. the implementation of intelligence led policing models into operational policing across 'five eyes' countries has had mixed results partly due to cultural, financial and leadership issues in agencies that have attempted to put intelligence at the centre of strategic and operational decision making in policing (walsh ; ratcliffe ) . nonetheless, despite historical challenges in adopting intelligence led approaches, increasing fiscal constraints and the ever increasing demands on law enforcement in managing both high volume crimes and complex operating environments in counter-terrorism, cyber and organised crime meant, at least in many national law enforcement agencies; a greater demand for an intelligence driven approach (walsh ) . this intelligence driven approach, which promulgated proactive disruption of crime strategies was in part an admission that not all crime could be prevented or the offenders prosecuted. additionally, in many law enforcement agencies such as the australian federal police (afp), the growing volumes of information collected have given intelligence a more central role in triaging the significance of information, value adding to it and guiding investigators to targets and operations that are high priority; or have the greater likelihood of successful prosecution outcomes. in complex organised crime cases such as transnational drug trafficking, people smuggling and even terrorism and cyber threats, which we discuss shortly-intelligence driven disruption strategies have become increasingly popular for many 'five eyes' law enforcement agencies. this has particularly been the case where it can be difficult to dismantle completely the organised crime group-or to even know the full extent of the group's network. disruption operations that attempt to take down threat actors with key roles (e.g. facilitator, financier, and logistics) may nonetheless reduce the threat posed by the organised crime network even if the network continues to exist. additionally, with some organised crime networks, it may be difficult to secure sufficient evidence for prosecution against a more serious offence such as drug importation, but there may be sufficient intelligence that can be used to make the criminal environment more hostile for the group's illicit enterprise by arresting key group members for lesser offenses such as unexplained wealth or migration irregularities. while disruption of crime does seem like a useful tool in preventing or reducing the impact of offenders, the criminology literature demonstrates it has been difficult to evaluate the effectiveness of intelligence driven disruption strategies. ratcliffe cited an rcmp disruption attributes tool, which attempts to examine where the disruption activity is aimed at (core business, financial, personnel) and whether the kind of disruption for one or more of these attributes is high, medium or low in impact (ratcliffe : ) . however, such tools are largely subjective and qualitative-making it difficult to accurately measure the impact of intelligence driven disruption measures. the other concern about disruption strategies is that they may just cause displacement, where other criminal enterprises take the place of those removed by law enforcement or as innes suggest, 'disrupting a network may just provide a vacuum for more dangerous offenders to step in' (innes and sheptycki : ) . finally, the literature suggest that employing effective disruption strategies rely on proactive collection and valid analysis that can led to both timely strategic and operational outcomes that in turn result in threat mitigation and harm minimisation. so are there benefits for the intelligence community working on bio-threats and risks to investigating research and practice for disrupting threats in the organised crime context? the answer is a qualified 'yes'. much of course depends on the nature of the threat and risk posed. clearly as with any crime, it is hard to disrupt a bio-threat, when it's still in the head of the offender. however, we do know that criminal and terrorist acts don't just happen spontaneously. there usually involve predicate steps taken by the offender. some of these might happen in very compressed periods while in other offences planning may take years. either way, and regardless of whether these can be detected by the intelligence community, there is likely to be some signs in the predicate planning stages of an impending threat/risk that can provide the intelligence community opportunities for disruption. it is difficult to say in which bio-threat cases disruption strategies will be most successful. much will depend on how quickly the intelligence community can collect and analyse information that may be indicative of an evolving bio-threat and risk. as discussed previously, good collection and analysis is contingent on having robust core intelligence processes in place and more importantly effective intelligence governance. both are needed to ensure intelligence efforts are coordinated across multiple internal intelligence community stakeholders, with relevant knowledge-as well as ensuring information and expertise from external stakeholders (the scientific community) is available to provide earlier warning signs of an emerging bio-threat. while it is important not to over-play the potential for success of the kind of disruption strategies used against traditional organised crime groups, there are likely bio-threat scenarios where disruption strategies may make a difference. arguably, disruption of bio-threats could be on a continuum with the individual threat actor on one end and a sophisticated organised group on the other. at the individual level one could have the scenario of a lone terrorist actor or a mad/bad scientist. while it may seem difficult to get early warning of the malicious act of mad/bad scientist, we saw in the earlier discussion on 'insider threats' that it may be possible to disrupt their activity before you reach an amerithrax style attack. twenty/twenty is hindsight with the bruce ivins amerithrax case, but the lessons learnt from this incident do provide guidance on the sources of collection and analysis required from within the intelligence and scientific communities to aid the disruption of this kind of bio-threat. it does not mean that all similar cases of 'insider threats' will be detected, prevented or disrupted, but a more careful collection and analysis of 'odd' behaviour or unusual security lapses by a scientist working in a high containment lab could reveal areas of vulnerabilities. detection both of abnormal changes to an individual's psychological profile and/or in their working environment can provide opportunities for those vulnerabilities to be disrupted. at the other end of the bio-threat scale, a more organised bio-criminal or terrorist planned event may resemble in some respects other illicit criminal markets and networks (drugs, identity fraud, money laundering) and thereby present opportunities for disruption. again this is not to suggest that disruption of organised bio-threat scenarios will be always be possible. as discussed in earlier chapters, since / , even with state based wmd programs the intelligence community has had a mixed record in detecting them and uncovering the intention and capability of non-state actors to exploit dual use technology for malicious end remains difficult. however, disruption could be useful in some bio-crimes where there is a bigger network of actors involved in the illicit business. for example, in crime scenarios where food suppliers are not registered legally to import food into a 'five eyes' country because it poses a biosecurity risk, there may be opportunities for parts of the intelligence community (particularly national law enforcement agencies) to work with agriculture, animal health, food regulatory agencies and relevant scientific stakeholders to disrupt illicit food suppliers from a country of concern. equally there may be opportunities for disruption of activity from non-compliant biotechnology providers in a 'five eyes' country, who provide dual use equipment to a company overseas with a questionable profile that resides in a country vulnerable for terrorist infiltration. in addition to useful knowledge that can be gained from criminology and law enforcement practice there are also perspectives on disruption from contemporary counter terrorism studies that may have utility in the bio-threat and risk context. as noted above, since / law enforcement agencies across the 'five eyes' countries have been increasingly deploying disruption strategies in countering terrorism given the preservation of life demands an earlier interception of attacks preferably at the planning stage. as innes suggest in the case of counter terrorism operations, one aim is to overtly disrupt planned attacks, which has many effects including sending a message to other terrorist groups that they may be next, reassuring the community and if possible deploying countering violent extremism (cve) strategies in communities where future attacks may arise (innes et al. : ) . in the uk in particular, a key plank in its counter terrorism strategy has been disruption both at the strategic and tactical level. at the strategic level, disruption has involved a number of initiatives from arresting persons of interest, legislative action and enhanced surveillance (innes et al. : ) . in addition to global influence of groups such as al qaeda and islamic state, the growth in lone actor attacks-some across the us and european countries from s to late s (danzell and montanez : ) has also been a significant catalyst for enacting further stringent legislative measures such as detention without trial and control orders (walsh ). all 'five eyes' countries have also adopted further legislative changes that allow disruption of terrorist attacks by reducing thresholds law enforcement and intelligence agencies need for reasonable suspicion in order to access both electronic and human intelligence (humint). governments desire to do something to reduce the threat and risks posed by terrorists by creating increasingly proactive, flexible and permissive legislative environments has also raised concerns about the role of intelligence, secrecy and privacy. these issues will be discussed as they relate to the bio-threat and risk context in chapter . but legislation is only one plank in effective counter terrorism and the scale and pace of actual and potential terrorist attacks suggest other disruption strategies are required at the tactical level. innes et al. suggest such strategies might include: 'prosecution against an individual or a network for offences other than those they were principally being investigated for and/or interfering with the operations of the criminal enterprise in cases where there is insufficient evidence to secure prosecution ' ( : ) . they add that, at the tactical level, disruption strategies can 'interfere with the ability of suspected adversaries to operate effectively and efficiently' (ibid.). innes et al. suggests that tactical disruption functions at 'near event interdiction', which can mitigate or minimise harms associated with the actual or planned terrorism attack (ibid.). other counter-terrorism disruption strategies in 'five eyes' countries have included the creation of cve policies and interventions as well as the disruption or take down of social media venues advocating politically motivated violence or recruitment to jihadist groups. regardless of the complexity of post / terrorist attacks-such as the multi-site attacks in paris orchestrated by a group; or the knife attack against two police officers in australia in by one individual-disruption strategies employed by law enforcement and national security intelligence agencies are also likely to be usefully employed in the bio-threat and risk context. just how useful strategic and tactical disruption strategies used in conventional counter-terrorism will be in the bio-threat context depends on the nature of the intent and capability of individual threat actor(s) and the risks posed by their actions. the effectiveness of disruption strategies in the bio-threat context like conventional terrorist attacks are contingent on a range of variables that are unique to that event. in the bio-threat context, leaving aside large levels of uncertainty about the future threat trajectory for bio-terrorism, effective disruption will rely on law enforcement and intelligence agencies understanding how the intention, capability and opportunities of threat actors operating in a particular environment-make an attack possible. intention, capability and opportunities will differ along the threat continuum from individual to group and from state to non-state actor. for example, in the research facility, hospital or high containment laboratory environment, intention, capabilities and opportunities may be shaped by actors that are internal, external or an indirectly involved in the facility (perman et al. : ) . threats can also be as perman suggest overt or clandestine (ibid.). in some cases, if a scientist is motivated politically (for religious, environmental or political reasons) to commit an act of violence by using a biological agent it may be easier to disrupt their activities if they are public about their agenda. however, in the case of a clandestine plan it could be very difficult to disrupt an attack launched externally or internally in a contained lab. nonetheless, as we saw with historical cases of lone actor threats such as the bruce ivins amerithrax incident there are likely predicate steps in the process to carrying out an attack which are revealable. similarly, in the lesser known case of dr. larry ford, who was suspected of murdering his business partner in a biotech company-the police subsequently found a cache of weapons, white supremacist writings and allegations that he attempted to infect six mistresses with biological agents (perman et al. : ) . again even in cases of lone actors such as this whose attack planning is more clandestine; there may well be an abundance of 'warning intelligence' that if collected and assessed in time might be useful in disrupting a lone actor planned attack. while it can be difficult to disrupt a lone actor plot, more elaborate ones by a group of conspirators could in some circumstances provide greater opportunities for interception and disruption by law enforcement and intelligence agencies. this is because in plots involving multiple actors there are more stages before the attack can be carried out. some stages such as communications, procuring supplies and transport also provide points of vulnerability, where threat actors can be exposed to authorities and disrupted. so an external threat such as a terrorist attack against a high containment laboratory might involve communications amongst group members, financing of the plan, purchasing of explosives and surveillance of the facility's perimeters. each stage presents opportunities for disruption providing intelligence and information is available to law enforcement and intelligence agencies. similarly a theft of intellectual property or biological material from a private sector biotechnology company might result from either an external criminal group; or state actor pressuring or paying an employee to steal information on their behalf. again, intelligence may exist already about the criminal group or the compromised employee that provides opportunities for disruption. in an ideal world of course, it would be desirable if all potential biothreat and risk scenarios could be prevented early in the intent stage, where they are mainly an idea in a perpetrator's head. pre-employment screening, including criminal checks and select agent risk assessments will show up some individuals, who are not suitable to access and work with dangerous biological agents. this will have an early disruptive effect but it is not fool proof. people can lie about their circumstances in security suitability checks allowing them the ability to access and plan malevolent acts in a secure biological facility rather than just thinking about them. once operating inside a facility-depending on the nature of the planned attack it can be very difficult for law enforcement and the intelligence community to respond quickly enough to disrupt the attack before its fully implemented. in all threat scenarios (simple to complex) in addition to the mandatory background checks for workers, each scientific institution needs to develop a full suite of threat assessments that can be updated regularly on different threat actors, including but not limited to: visitors, criminals, lone actor attacks (internal and external), terrorist and issued motived groups, international terrorists groups and foreign powers (perman et al. : ) . these threat assessments should be developed by an institution's internal security department in collaboration with local law enforcement. the relatively low number of threat scenarios that have taken place involving bio-agents since / will likely mean that there will be many intelligence gaps in assessing the intent, ability and opportunity of different threat types. however, providing baseline threat assessments will begin to build pictures of threats scenarios that should help promote better biosafety measures as well as opportunities to disrupt threats earlier should they begin to emerge. in summary, law enforcement and intelligence agencies working on bio-threats and risks of the future can learn a lot from their counter terrorism colleagues. since / , countering terrorism continues to produce lessons for the law enforcement and intelligence communities on how more effectively to disrupt emerging terror plots before they are implemented. the knowledge gained from investigating conventional terrorism attacks that don't involve biology can help those working on future bio-threats and risks by seeing how to optimise the legislative, intelligence, investigative and community response to terrorism while also learning lessons from contemporary counter terrorism efforts. in particular, the increase in lone actor terrorist attacks in the westoften with short notice underscores that either an insufficient amount of intelligence or types of intelligence that cannot be revealed in court often exists. in these cases, other tactical disruption strategies are gaining traction amongst 'five eyes' countries to mitigate the threat and harm posed by terrorists. similarly, given the complexity of threat scenarios that could arise from the exploitation of dual use biotechnology, it may be difficult in some cases to collect sufficient solid 'evidence' or use bio-forensics to attribute confidently for a conviction on bioterrorism or bio-criminal activity. nonetheless, the various counter terrorism strategies discussed above point to ways threat actors may be disrupted on lesser offences while also providing a greater intelligence dividend on other individuals involved. the final knowledge area and stakeholder group that intelligence agencies and investigators working with bio-threat and risks may learn more from is cyber security. as koblentz and mazanec ( ) suggest there are a lot of common characteristics between biological and cyber weapons including but not limited to: difficulty of attribution and how multiple technologies can be used for offensive, defensive and civilian applications ( - ). both authors argue because of these similarities there is likely a lot cyber can learn from how bio-threats have been managed historically. this is undoubtedly true, though in this section the focus will be the opposite-i.e. what can intelligence and investigative agencies working on bio-threats learn from the cyber threat and capability landscape? even a cursory review of the literature suggest that there are a number of areas where current cyber research and practice could inform the 'five eyes' intelligence communities understanding of current and emerging bio-threats and risks. space does not allow an exhaustive discussion on all of them, but there are three cyber areas in particular; where i believe those working with bio-threats and risks could benefit greatly from knowing more about in order to learn the lessons from the cyber context as well as identifying good intelligence and investigative practice. these areas are: the dark web, cyber terrorism and cyber espionage. i will discuss each briefly in turn. turning to the dark web environment first here we are referring to the content on the internet that is 'not indexed by standard search engines' (weimann : ) . much of the dark web is hidden or blocked and can only be accessed by specialised browsers. given the relative anonymity it provides, the dark web has seen the proliferation of child pornography, credit card fraud, identify theft, drugs and arms trafficking amongst other illicit offences. the dark web only emerged in recent years though law enforcement and intelligence agencies have made some in roads into its penetration and disruption. the fbi's shut down of the dark web site silk road, which operated between february and october was to that point the largest and most sophisticated anonymous online market place for illicit drugs (zajácz ) . new technological solutions are also being developed to better identify, collect and analyse illicit activity on the dark web, including darpa's memex software, which helps catalogue dark web sites (weimann : ) . nonetheless, all 'five eyes' intelligence communities will need to continue to develop their collection, analytical and investigative capabilities in the dark web content to profile more accurately various illicit market places in order to orchestrate impactful disruption activity across multiple markets. although it is unknown, at least in an unclassified sense the extent to which illicit markets exist that could benefit bio-threat actors (criminals or terrorists), undoubtedly law enforcement and intelligence agencies, who are given a watching brief on emerging bio-threats and risk should be exploiting the dark web more for opportunities for disruption. a first step might be first to map the bio-terrorism literature and identify researchers, who have access to bioterrorism agents/disease research, domain, institutions, countries and emerging topics and trends in bioterrorism agents/disease research. chen shows how by using informatics research it might be possible to use knowledge mapping techniques, to analyse productivity status, collaboration status and emerging topics in the bio-terrorism domain (chen : - ) . additionally, other intelligence and investigative teams that are working on non-bio threats such as conventional terrorist attacks, terrorism financing, drug trafficking or even child sexual exploitation may come across offenders, who have links to others interested in exploiting dual use biological agents for malevolent objectives. so the work currently going on by intelligence agencies working on broader cyber security issues such as cybercrime or cyber terrorism is directly relevant to improving collection and analysis against emerging bio-threats and risks. developments in the second area cyber-terrorism provides another opportunity for bio-threat intelligence and investigative teams to learn off their colleagues working on cyber threats. in the past we often think about the classical 'bio-terrorism' attack involving the aerolising and dispersal of a dangerous pathogen like anthrax into a crowded place. this mode of attack may still be chosen in the future by a terrorist group (leaving aside for a minute the technical difficulties of such an attack). though committed acts through cyber opens up other choices for a bio-attack. cyber security specialist's knowledge of cyber terrorism is still developing. we have seen for example groups like the taliban and is increasingly use computers for recruitment, propaganda and communications, but it remains difficult to know empirically how many of the current virtual attacks such as ransomware can be attributed to terrorist or led to deaths or impacted critical infrastructure in significant ways. such attacks could just as easily be attributed to cyber hackers (criminals) or state sponsored espionage both issues we will return to shortly (riglietti ; bernard ; heickerö ) . nonetheless, it is clear that terrorism groups are increasing their use of computers including the dark web given they know that intelligence communities are monitoring the surface internet and social media. in august , al-aan tv reported a laptop belonging to a tunisian member of is captured in syria contained thousands of documents from the dark web including pages about making biological weapons in a way to impact the biggest number of people (weimann : ) . there have also been cases where is has carried out a series of cyber-attacks, 'exclusively computer based, which in one instance even led to the disclosure of private information regarding us government officials, from private conversations to work and email addresses' (riglietti : ) . the final area of cyber security that is useful for bio-threat intelligence and investigative teams to reflect on relates to cyber hacks and espionage. putting hacks and espionage together is not meant to suggest that both are always linked-though we have seen in the russian interference in the us presidential election they can be. china too is playing an increasingly sophisticated and aggressive cyber espionage strategy aimed at political interference and stealing intellectual property (inkster ) . there seems little doubt that the extent of hacking (unauthorised access to a computer or network) being perpetrated by state and non-state actors is on the rise and network vulnerabilities across the civil and military space remain. in a recent article, fbi assistant special agent in charge (chicago), todd carroll said the average time between an unauthorised user getting inside a network and the user being detected is days-'a lifetime in cyber means'. todd went on to say that % of business owners don't have a dedicated employee or vendor monitoring for cyber-attacks (stone ) . we have also seen in recent years the growth in malware and ransomware attacks across the globe. for example, in the wannacry ransomware attack caused , infections across countries (locking down banking, energy and manufacturing systems) (schilling ) . the dark web also provides terrorist and criminal groups opportunities to operate botnet campaigns in anonymity that can remotely operate networks of computers to commit attacks on other systems including critical infrastructure. again there is insufficient space to provide a full survey of all the cyber hacking and espionage threats, and indeed what to do about them is beyond the scope of this chapter (clarke and knake : - ) . nonetheless the hacking attacks-whether they are state sponsored (espionage) or non-state actors (terrorists or criminals) provide another rich source of knowledge to be collected and assessed that can be used by those working on emerging bio-threats and risks. for example, it would seem unwise for bio-threat intelligence and investigative teams to not learn from the fast changing angles of cyber-attack from hackers given how the physical security of biological institutions, their intellectual property and the kinds of biological products produced in such facilities is reliant on secure cyber systems. we have seen in recent years the take down of government websites involving ransomware attacks on both government and private sector networks. increasingly more information is being shared and stored via the cloud. what would be the impact of a major ransomware attack that locks down the entire bio-surveillance capability of a public health authority such as cdc do to maintaining national health security? could a cybercriminal group infiltrate the network of a major biodefense company steal ip and sell it to a terrorist group on the dark web? could research stored via the cloud on non-secure networks relating to the genetic sequences of pathogens be stolen by a terrorist group or state actor to engineer bio-weapons? (blue ribbon project : - ) . in all the three areas discussed above, a fuller development of links between those working in the cyber intelligence collection and analysis streams, and those who might examine emerging bio-threats and risks is a necessary first step in bringing relevant knowledge and practice from cyber security to bio-threat stakeholders. in this final section the attention is turned to what kind of stakeholders play a role in treating bio-threats and risk? second, in performing these roles, how can they help the 'five eyes' intelligence communities build better capability (knowledge, practice and technology) about treating actual or emerging bio-threats and risks? as we have seen so far the management of bio-threats and risks is potentially a crowded enterprise with many stakeholders (beyond the intelligence communities) playing critical roles. in this section, i have grouped them into three 'types of stakeholder': first responders, science and technology stakeholders and security stakeholders. these are not three distinct clusters of unique stakeholders that do not interact with each other. depending on the nature of the bio-incident that has occurred, one would expect to see a close interaction amongst the various knowledge brokers and practitioners from each group. for example, a release of a synthetically manufactured select agent in an airport should result in the combined strategic and tactical contributions from first responders, engineers and security personnel rather each being delivered in isolation. an uncoordinated delivery of knowledge, practice and expertise to treat an unfolding bio-threat/risk from multiple stakeholders will not result in the best outcome for mitigating the risk or disrupting future potential of similar threats occurring. again as with previous sections, the focus here is not a deep exploration of the specific knowledge, practice or technology of all stakeholders involved potentially in the treatment of bio-risks. this would be an impossible task. instead this section will explain briefly what each of the three broad stakeholder categories (first responders, science and technology and security) can do broadly to treat bio-risks (current or potential), what intelligence communities can learn from this in ways that extend their capabilities to manage bio-threats and risks. the label 'first responders' is a descriptor for a much broader range of stakeholders including: fire/hazmat, paramedics, emergency responders, health and hospital service providers. each would play a different role in both responding to and treating a bio-incident depending on the type of biological hazard, their jurisdictional and legislative responsibilities and fiscal capacity. in all 'five eyes' countries with perhaps the exception of new zealand (with a smaller population and only one national government) the complexity of response will be particularly governed by the overlapping roles that various local, state and federal first responders might play. obviously in the us with multiple federal, state and local agencies, the coordination of first responder efforts to a bio-incident presents more challenges than other 'five eyes' countries such as australia and the uk with less agencies and jurisdictions. there is not an abundance of academic literature on the role of first responders in treating bio-threats and risks. this lack of evidence makes it difficult to assess accurately what first responders can do to treat bio-threats and risks, what the challenges are and what the intelligence community can learn from these important stakeholders. there is however, some research available that can increase the intelligence communities' understanding of first responder capabilities to treat bio-threats and risks as well as illuminate some of the challenges in doing so. this research should provide at least a start to what the intelligence community can learn from first responders as they deploy their knowledge and practice to disrupt and treat bio-threats and risks. / and the amerithrax incident provided a catalyst for law enforcement and public health agencies to work closer together to respond to an unfolding threat. since amerithrax, across the 'five eyes' countries further work has been done to better coordinate the work of law enforcement and public health agencies on treating bio-threats and risks. but such efforts have not involved routinely the broader spectrum of national security intelligence agencies, who have tended to play a more strategic and adhoc role compared to their law enforcement counterparts. overall, policy, coordination and legislative efforts to bring first responders and members of the intelligence and law enforcement community together have had only mixed success for a number of reasons. in , a study of how law enforcement and public health agencies in the us, canada, uk and ireland work together on bio-threat incidents identified several common barriers to improving multi-agency responses (strom and eyerman ) . these included cultural, legal, structural, communication and leadership barriers (ibid.: ). ten years on from strom and eyerman's research, other researchers have made similar observations about the ability of first responders to manage effectively a bio-threat incident and to work with law enforcement and intelligence community on such tasks. but it's not just the capability issues raised above, other research points to other technical challenges to treating the impact of bio-threats and risks in the physical environment. for example, research by chemists and environmental engineers show that given the varying nature and strains of the bacteria-the science for assessing risk of exposure may not be able to provide a fully accurate risk assessment of a building's vulnerability or resilience to a bio-attack nor-in some cases whether first responders have effectively 'cleaned the environment up after exposure' (canter ; taylor et al. ) . a lack of effectiveness in responding to a biothreat incident in a local area obviously can have broader public sector implications in both treatment and preparedness of bio-risks. for example, gerstein ( : ) citing a study by advocacy group trust for america's health reported that states and dc scored / or lower on a scale for preparedness. additionally, since / major disease outbreaks such as sars and ebola have also demonstrated fragility in parts of the world, including some 'five eyes' country's public health response capability, which remains a concern if there was a major bio-terrorist event. the blue ribbon study project report raised similar concerns about the capability of certain responders including those local, state and federal agencies that might be involved in decontaminating sites following a bio-incident. in the us, the report raised similar coordination issues between federal, state and local agencies in which first responder agency would take the lead in decontaminating and remediating environments and how other agencies would get involved to ensure the attack site was deemed safe for people to return (blue ribbon study project : ). one underlying theme arising from the studies mentioned on first responder's roles in treating bio-threats and risks is that the intelligence community must share more information with emergency services on the nature of the threat they are meant to respond to. this is not to suggest that in all the 'five eyes' countries that no sharing is going on. my selected interviews with law enforcement and intelligence officials in each country did not give the impression that no sharing was going on with first responders. however it is clear if the local fire officers or emergency staff in a hospital are meant to better respond to a bio-incident they will need regular, consistent, reliable, real-time information and intelligence. this is vital to them safely securing the scene, or rapidly diagnosing and treating infected patients while also keeping themselves safe. importantly too, the more intelligence they receive will likely be helpful in first responders preserving any relevant evidence from the scene that might be needed by the either the law enforcement and intelligence communities. gerstein makes a valuable point when referring to improving bio-preparedness and response activities, when he suggests that first responders need to be seen as part of a complex system rather than each representing a series of programs (gerstein : ) . in addition to the range of knowledge and practice the intelligence community can learn from first responders, arguably the biggest lesson they can learn is to seek to better understand the 'linkages among disparate disciplines (biodefense, public health, emergency management), government, industry, the scientific community and themselves to better support first responders' (ibid.). if the 'five eyes' intelligence communities were able to create the necessary national health security coordination arrangements suggested in chapter such as the health security coordination council and the national health security strategy, then through these institutions further intelligence sharing mechanisms could be established to improve information flow between the intelligence communities and first responders at federal, state and local levels. however, first further research is required to investigate how law enforcement and intelligence communities work currently with first responders to identify and as much as possible ameliorate the cultural, legal, communication and leadership barriers that persist. a second cluster of knowledge and stakeholders for treating bio-threats and risks could be loosely described as 'science and technology' stakeholders. in earlier sections, under the relevant headings (prevention and disruption), significant space was devoted to how our intelligence communities can learn from a range of stakeholders working across a diverse array of disciplines (including bio-surveillance, public health, biosafety, criminology, counter terrorism and cyber). in each of these disciplines, discussion included exploration of relevant science, technology and knowledge useful for the intelligence community in preventing and disrupting bio-threats and risks. some of that discussion, for example bio-surveillance, biosafety and strengthening global health is also relevant to our focus here in treating bio-incidents. however, in this section the focus is not what the intelligence community can learn from stakeholders working in the above disciplines, but rather what they can learn from disciplines more removed from the biological sciences or relevant social sciences (e.g. engineering or security studies). what can the intelligence community learn from physical, mechanical or environmental engineering? there are multiple roles engineering specialties could play and are playing in preventing, disrupting and treating bio-threats and risks. for one and historically, the us dod has relied on engineers, microbiologists to provide advice on weaponisation of biological agents under a range of scenarios and conditions (state actor and terrorists threats). for example, even pre / , between and dtra funded project bacchus to see if a team of scientists and engineers, who allegedly did not have extensive experience in bio-weapons could make bio-weapon facility using just commercially available items. the objective was to see if the team could make anthrax successfully without the detection of the intelligence community, though it was later revealed that this team did have substantive technical knowledge and support throughout this project (vogel : - ) . engineers have also long been engaged in studying aerolisation dynamics, which has become increasingly a multi-disciplinary collaboration of environmental engineers, biomedical engineers, microbiologists, chemists and epidemiologists (xu et al. ) . related to aerolisation studies has been the work of hardware and software engineers-many of whom came from the aerospace and automotive industries that have brought their skills into modelling bio-terrorism attacks to help first responders predict how airborne particles might move through sections of a city under certain weather and windflow conditions (thilmany ) . other engineering studies, sometimes referred to bio-protection studies have been important in the design of the heating ventilation and air conditioning (hvac) systems used to resist biological contaminants. much of this research became activated after the amerithrax incident, and is designed at reducing the health consequences from airborne contaminants by augmenting heating and air conditioning systems (ginsberg and bui ) . another focus of engineering led research relates to improving the portability, speed and reliability of bio aerosol monitors for pathogens. one recent study has been working on a device that would be fully portable and automated-capable of detection of selected air-borne microorganisms on the spot-within to minutes depending on the genome and particular strain of the organism (agranovski et al. ). in this last sub-section in our exploration of what other stakeholders may be useful in treating bio-threats and risks we turn our attention to the role of security officers. i am conscious in the discussion above regarding prevention and biosafety much was said about the role of security officers and managers in promoting biosecurity and biosafety across all sectors of the bio-sciences enterprise (e.g. research centres, hospitals, biotechnology companies, public and private labs). in this section, we focus instead on the role of security officers and managers across the broader economy-beyond biosciences. as argued in previous chapters, in addition to taking a one health perspective to bio-threats and risk, 'five eyes' intelligence communities and their law enforcement colleagues need to also understand the potential development of biothreats and risks beyond the technical world of biotechnology and labs to include also in their wider social, economic and community contexts. hence in this section, we are referring to the role of security officers and companies that work across the international, national, state and local economies in each 'five eyes' country. given the trajectory of most (if not all) future bio-threats is unknown, our intelligence communities need to be forging more formalised (less adhoc) relationships with security officers in a range of non-biotechnology industries (banking, mining, food supply, agriculture, critical infrastructure). as nalla and wakefield ( ) argue several factors have increased the role of private security since the second world war. increased economic wealth, enhanced security technology (alarms, access control and cctv), in addition to an increase in the control by a number of private sector companies of publicly accessible places have, amongst other factors all contributed to the growth in private sector security (ibid.: ). while it is difficult to generalise 'as the functions of security officers/agencies are as varied as the organisations that employ them' (ibid.: ), their functions and roles cut across many facets of each 'five eyes' nation to include office buildings, warehouses, shopping malls, education establishments, residential complexes and critical infrastructure. one often thinks of the classic scenario of a security guard standing in front of a physical gate, which is one role of many others which might also, depending on their functions include traffic control, surveillance, responding to emergencies, security vetting. in the security role of complex large companies, airports and electricity plants, it is likely that the security officers will have a deep understanding of their physical and virtual security environments and this kind of expert knowledge would be integral for them and the intelligence community gaining threat awareness, prevention, surveillance, disruption, treatment and recovery to bio threats and risks which may manifest in their operating environment. historically however, the relationship between intelligence communities (including law enforcement) and private sector security has not been optimal partially because a lack of trust between both (ibid.: ). however, several studies on private and public sector security do show several areas of improvement across each 'five eyes' country. some of these improvements have been initiated by governments such as in the uk making significant cuts to policing in the late s and mid- s and seeking the private sector security sector to pick up more cheaply what were considered less core policing such as offender management and transfers of prisoners. in other cases, governments were interested in engaging with the private sector to extend their own security and intelligence collection capabilities with terrorism. connors et al. ( ) , wakefield ( ) , and rigakos ( ) provide more detailed analysis of a range of factors that have been involved in building partnerships with private sector security companies in the us, uk and canada respectively. / and of course subsequent terrorist attacks in many western countries has seen a more focused attempt by 'five eyes' countries to reach out to the private sector-including private sector security given many attacks occur in public places owned or managed by the private sector. threats as well to public and privately owned critical infrastructure (aviation, power, water, and telecommunication) have also influenced 'five eyes' government's closer liaison with the private sector. for example in the us, dhs has established a private sector office to provide government advice on relevant security issues to the private sector as well as promoting public-private partnerships. in australia, since / parts of the australian intelligence community, particularly asio has developed closer links with the private sector. in australia's attorney general's department created the business-government advisory group on national security to provide a vehicle for the government to discuss a range of national security issues and initiative with ceos and senior business leaders (dpm &c : ). the group later ( ) evolved into the australian governments industry consultation on national security (ibid.). more recently ( ) the australian government released its strategy for protecting crowded places from terrorism. this significant policy document was developed in close partnerships with federal, state and local governments, the intelligence community and the private sector. the key objective being to assist owners and operators to increase the safety, protection and resilience of crowded places across australia (anzctc ). an interesting aspect of this strategy is that it places the primary responsibility for protecting sites and people on private sector businesses. similar policy articulations have been declared in the uk's counter-terrorism strategy (hmg ) and canada's approach to counter-terrorism (canadian government ). in summary, it's clear that various agencies of the 'five eyes' intelligence communities and their broader law enforcement counterparts have increased their liaison and implemented various initiatives with private sector industry. what is less clear is the nature and extent of these as they relate to the prevention, disruption and treatment of potential bio-threats and risks. much is unknown, for example, about whether intelligence and law enforcement communities are actively working in partnership with the private sector beyond the classical threat typologies of basic terrorist's tactics, improvised explosive devices or vehicle born attacks. given the low probability high impact nature of the evolving bio-threat environment, it is likely that many private sector companies (banking, shopping malls, mining, hotels) see little need to include bio-threats in their security risk management plans or indeed consult with intelligence and law enforcement communities on them. while it is important not to be alarmist on low probability threats that are more likely on balance to effect the biosciences community rather than the broader private sector economy, it seems unwise for the latter not to consider the impact of such bio-threats on their operations and to at least have formalised dialogues on these with the intelligence community. but such a dialogue will in the future rely on several factors identified already by researchers coming together to develop more effective public-private crime prevention strategies. prenzler and sarre list several factors including: a common interest in reducing a specific crime, leadership, mutual respect, information sharing based on high levels of trust in confidentiality and formalised mechanisms for consultation and communications (prenzler and sarre : ) . this chapter surveyed the role of external stakeholders external (to the 'five eyes' intelligence communities) in preventing, disrupting and treating bio-threats and risks. depending on the particular bio-threat a diverse array of stakeholders could provide knowledge, skills and capabilities to the intelligence community. the large number of disciplines and stakeholders with relevant technical knowledge suggest that they will continue to play a critical role in the prevention, disruption and treatment of bio-threats and risks. in many cases, such as in biosurveillance, forensics and even engineering the scientific and technical stakeholders discussed here may play a greater role than the traditional intelligence and investigative response to managing bio-threats and risks. the chapter also highlighted that although each 'five eye's intelligence community has a wealth of knowledge to tap into from stakeholders, however in most cases all stakeholder groups are faced with their own theoretical and practical limitations. analysts and investigators working on bio-threats and risks need to understand these limitations while also seeking to build deeper and more formalised partnerships with scientific, technical and cross disciplinary stakeholders. in the final chapter , we shift the focus away from the practice and processes involved in interpreting bio-threats and risks to oversight and accountability issues. given the legislative, ethical and normative challenges modern intelligence practice faces, particularly in understanding the potential threat trajectory of synthetic biology, what role can oversight and accountability play in achieving the objectives of the intelligence communities in liberal democracies? miniature pcr based portable bioaerosol monitor development australia's strategy for protecting crowded places from terrorism. anzctc, australian government biological weapons-related common control lists biosafety and biosecurity as essential pillars of international health security 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months of the epidemic and forward projections signal recognition during the emergence of pandemic influenza type a/h n : a commercial disease intelligence unit's perspective. intelligence and national security utility and potential of rapid epidemic intelligence from internet-based sources labs cited for 'serious' security failures in research with bioterror germs silk road: the market beyond the reach of the state key: cord- -nezgzovk authors: henderson, joan c. title: tourism and health crises date: - - journal: managing tourism crises doi: . /b - - - - . - sha: doc_id: cord_uid: nezgzovk nan health and tourism are connected in many ways and there are several distinct areas of study which include the physical and psychological benefi ts of vacation travel, the pursuit of improved health being a major motivator for tourism. however, there are dangers to health arising from participation in tourism and they can result in the emergence of tourism crises. such situations and approaches to their resolution represent the subject of this chapter in which health risks when traveling and on arrival at destinations are considered, with a section devoted to infectious diseases affecting humans and animals and birds. a distinction is made between involuntary and voluntary health threats, the latter illustrated by sexually transmitted illnesses and adventure tourism, which are also examined. responses to these various types of tourism crises are then reviewed and detailed case studies of the outbreak of sars and airline policy regarding deep-vein thrombosis (dvt) are presented at the end of the chapter. these examples afford insights into the impact of health-related tourism crises and their management at an international and national, and industry and corporate level, respectively. health is a major public and private concern in general and a key element in destination choice and visitor satisfaction, with individuals and the tourism industry likely to shun environments where there might be a risk to tourist well-being. while tourism's contribution to an enhanced state of mind and body is widely accepted, many health hazards confront overseas and domestic travelers (clift and grabowski, ; ncbi, ; who, ) . these hazards have the potential to become crises for organizations and destinations when problems are severe and impact on a place's reputation and arrivals (thompson et al., ) . some studies have concluded that the health of as many as % of participants is impaired by the experience of international tourism (dawood, ) and the rise in foreign travel has been accompanied by an increased incidence of disease, especially that of a tropical nature (connor, ) . an ageing population also means elderly travelers who are often more vulnerable to health risks. tourism has additional repercussions for the health of destination residents (rodriguez-garcia, ) who tend to be neglected in any discussion (bauer, ) , but this theme is not explored here. government and commercial tourism agencies must therefore face the likelihood of health-related crises occurring and manage their consequences, as well as undertake preventive action where possible. tourists themselves also have a part to play in terms of seeking information, taking precautions and behaving in an appropriate manner. the act of travel poses dangers, detailed in the next chapter within the context of technological failure, and each mode is distinctive from fl ying to cycling (nikolic et al., ) . there may be accidents due to mechanical failures, human error and adverse weather either independently or in combination and public vehicles are popular targets for terrorist attack, crises which are examined more fully in other chapters. air travel in particular has attracted considerable publicity with regard to both such events as well as its relationship with dvt and other medical conditions (see case one). it is not just tourists who are transported, but animal life which is a source of infection. the presence of rodents on planes, also a practical hazard, has been recorded as well as mosquitoes. shipping ports and airports may be infested by rats and insects, with implications for the health of those exposed to them and inhabitants of countries where the diseases they carry are imported (gratz, ) . cruising is a means of transport, although ships can be seen as fl oating resorts, and outbreaks of gastrointestinal illnesses on cruise liners are regularly logged (cdc, ) . even the most luxurious cruises are not immune from health problems which are aggravated by the higher age profi le of the cruise market, close proximity of passengers and the popularity of group activities. norwalk-like viruses, with symptoms of diarrhea and vomiting, infected about , passengers and crew members on two florida-based lines in late . the operators abandoned voyages so that the ships could be thoroughly cleaned and disinfected. there was a similar instance the following year, although the cruise proceeded as scheduled (see boxed case one). other reported maladies on board cruise ships are infl uenza, e. coli infections and shigellosis, which is a bacteria causing diarrhea (schlagenhauf, a) . the aurora was on a -day mediterranean cruise in when there was an outbreak of a very contagious norwalk-like virus. there were , passengers on board, over of whom fell ill with sickness and diarrhea alongside of the crew. the company maintained that everyone had recovered when the cruise ended at the british port of southampton. the virus is believed to be transmitted by personal contact and a "no touch" regime was imposed on the ship in a bid to contain its spread. shared utensils and condiments were withdrawn from eating areas and furniture in public spaces was carefully cleaned after use. passengers described how they had avoided touching surfaces like door handles. the usual medical complement of two doctors and four nurses was augmented by another doctor and nurse. the greek authorities refused to let the ship into the port of piraeus and spain sealed its border with gibraltar following its arrival there, despite offi cial protests. there were mixed reactions among the passengers on returning home about their experiences. some expressed themselves satisfi ed with the vacation and the company's response to the problems on board, believing that fellow passengers were embellishing the situation with a view to obtaining compensation. others were critical of the company for being slow to act in the initial stages of the outbreak and demanded refunds for expensive cruises which were priced between £ , and £ , . the managing director accepted that the circumstances had been unparalleled and exceptionally demanding for the medical and other staff. with regard to the compensation issue, he said that all the relevant correspondence would have to be considered and each case would be assessed individually. after docking and the disembarkation of passengers, the aurora was thoroughly disinfected by cleaners who had donned face masks. it then sailed away for a short channel islands cruise, having been booked for a conference. source: the guardian, . having survived the journey, tourists then face the possibilities of sickness and accidental injury on their arrival at destinations. the most prevalent forms of sickness resulting from tourism are often connected to standards of hygiene at destinations. poor sanitation and inadequacies of water supply and sewage disposal may cause intestinal infections like gastroenteritis, with contaminated seafood another source. diarrhea is a particular concern among travelers and one of the most common of travelers' complaints (ericsson et al., ) . these infections can strike and spread rapidly at venues where tourists gather such as hotels. malaria, yellow fever, cholera and dengue are more serious and can have fatal consequences. there are also bites, stings and skin infections to contend with as well as unaccustomed sun and high or low temperatures (keystone et al., ; zuckerman, ) . the severity of health hazards and sensitivity to them partly depends on location, activity and the tourist's physical fi tness. for example, those traveling off the beaten track in regions such as south east asia, the south pacifi c and amazon basin are in danger from endemic ailments (rudkin and hall, ; shaw and leggat, ) . it seems probable that more tourists will succumb to both common and rarer diseases as peripheral areas of the world become accessible, a trend fueled by enthusiasm for ecotourism and other manifestations of alternative tourism in which travelers seek to escape the trappings of the mass industry. articles in the journal of travel medicine portray a rather alarming picture of medical perils awaiting visitors in remote places, although these perils also lurk in mainstream centers (schlagenhauf, b) . cities too pose "myriad" threats which are especially acute in the developing world. they include "infectious diseases, trauma, air pollution, heat illness, crime and psychiatric illness" (sanford, , p. ). the catalogue extends to "sexually transmitted diseases" and "recreational drug use" which perhaps belong to the category of volitional risk. these circumstances could be a principal or secondary cause of tourism crises and indicate how certain classes of tourism crisis overlap as environmental and socio-cultural factors are also at work. threats are not confi ned to developing countries or tropical climates and can be found in temperate zones in the developed world. legionnaire's disease is contracted when mist is inhaled from tainted water sources such as air conditioning cooling towers, central plumbing machinery and whirlpool spas. it can therefore be caught within accommodation properties and conference centers and on cruise ships. there is a chance of tourists falling ill with respiratory viral infections like infl uenza, especially older people and those on organized group tour packages. poor food hygiene gives rise to food poisoning, cholera, e. coli infections, hepatitis a and salmonellosis. pathogens can be transmitted by food and ensuring food safety is an urgent task both currently and for the future (kaferstein and abdussalam, ) . discussions about health and tourism tend to focus on sickness and disease, additionally, accidents must not be overlooked, although empirical data are limited (page and meyer, ) . health considerations at destinations thus extend to personal accident and injury, vulnerability to these is perhaps greater overseas when tourists fi nd themselves in unknown environments. those injured may also not have easy access to appropriate facilities and treatment, aggravating the damage and impeding their recovery. unintentional injury is a universal health issue, but its prevalence can be partly explained by the extent of new travel opportunities in the current era when unprecedented numbers are on the move (mcinnes et al., ) . particular problems unrelated to tourist behavior and culpability are partly determined by the features of the destination. a bbc television program quoted by page and meyer ( ) examined some risks met by british holidaymakers in the mediterranean. these risks were often due to building construction and maintenance faults like improperly serviced gas fl ues in self-catering accommodation units, unsatisfactory fi re safety provision and swimming pool defi ciencies. any resulting crisis could therefore also be defi ned as technological in another example of crisis convergence. engaging in new pastimes may be risky and even familiar pursuits like driving can be dangerous, with statistics dominated by motor accidents. traffi c accidents involving hired vehicles are routine occurrences and may not always be the fault of the driver. resulting injuries and fatalities refl ect badly on any commercial operators implicated and, should they recur, on the location which could be tainted by perceptions that it is unsafe and regulations are lax. infectious or communicable diseases can be caught when traveling or after arrival and some have the ability to advance at great speed. rapid diffusion is facilitated by modern travel patterns and is diffi cult to control. containment is especially challenging for countries which lack resources, expertise and an adequate health-care infrastructure. any epidemics are not just a crisis for tourism, but for society at large and can assume a global signifi cance. resultant fears among tourists may be magnifi ed out of proportion, but the industry has to react to perceptions and not realities. although few tourists were directly in danger, pneumonic plague in india in led to a "global alarm which escalated in meteoric fashion" (clift and page, , p. ) . there was a % drop in arrivals and companies in overseas markets canceled their indian tours. reference has already been made to established diseases, but there are new fears about those which are emerging such as west nile fever and sars. there have been outbreaks of the former in the usa and sars had a devastating effect in , severely damaging tourism in parts of canada and across much of east asia despite the relatively small numbers affl icted (see case two). the virus led to health warnings being published by governments and offi cial bodies, the damaging infl uence of such advisories having already been discussed in chapter , and their revocation was a major step on the road to recovery. questions of health may impact on tourism in a more indirect manner as evidenced by agriculture and food industry emergencies which infl uence the attractive-ness of destinations and visitor volumes. one example is foot and mouth disease, which affects cloven-hoofed livestock and not humans, but can be carried on the soles of their shoes and vehicle wheels so that curbs on movement are a key instrument in fi ghting the disease. there was a particularly severe and prolonged bout of foot and mouth in the uk in when it was also detected in some countries in continental europe (horwath consulting, ) . news and photographs of the mass slaughter of herds of cattle and their incineration portrayed an unattractive picture of the british landscape, an offi cial report condemning "sensationalist" and "hysterical" media reporting at home and overseas (uk parliament, ) . restrictions imposed on access to farmland and misunderstanding about personal safety were other disadvantages with which the industry had to contend. footpaths in rural areas and some roads in national parks were closed, making it diffi cult to reach certain visitor attractions. fears that the uk was being depicted as a "disease-ridden hellhole" prompted a senior government offi cial to promote inbound tourism at a meeting he was attending in new york, and there was a wider campaign to assure visitors that britain was safe and "open for business." tourism suffered, with estimated losses of about £ billion (the financial times, ) , but the effect was concentrated in the countryside. hotels and attractions responded by intensifi ed marketing, price discounting and cost cutting and several businesses demanded assistance from government to alleviate their fi nancial plight. the ramifi cations of foot and mouth were felt elsewhere due to anxieties about its being unwittingly exported. busch gardens in tampa bay, florida, directed foreigners away from susceptible animals like giraffes and gazelles. visitors with a history of travel to infected areas were requested to desist from joining the optional tours, the highlight of which was close proximity to wildlife, and offered alternatives such as half-price entry to the water park (the business journal, ). immigration procedures were also modifi ed in an attempt to prevent the disease invading countries such as the irish republic where livestock farming is a key economic sector. international arrivals were asked to complete declaration forms concerning their travels and walk across disinfected mats when entering countries. avian infl uenza or bird fl u is a more serious illustration as humans can catch it from infected birds and now it appears endemic in parts of asia. cases in hong kong discouraged tourism in the late s and have the potential to do so elsewhere. an especially virulent strain was discovered in several east and south east asian countries in late . subsequent years saw further eruptions and its appearance in other continents, leading to the widespread culling of birds and attempts at immunization. there were also a number of human infections and several deaths. although most victims in cambodia, china, hong kong, indonesia, thailand and vietnam had been in contact with sick poultry, there are forecasts that it is only a matter of time before the potentially lethal virus mutates into a form which will allow human-to-human transmission among populations that have no immunity (who, ) . this could trigger a global infl uenza pandemic with millions of casualties and is a subject of grave anxiety for both health and tourism authorities. some countries have discussed closing their borders in a bid to protect nationals and it seems that international tourism would almost come to a halt and the international industry effectively cease to function if the worst scenarios were to be realized. the above health threats are largely involuntary, although certain measures can be taken to reduce their magnitude and possibly avert a crisis. however, other types of risk can be classed as voluntary and tourists frequently engage in careless behavior which endangers their health. it has also been noted that individuals perceive risks differently depending on personality and social circumstances (carter, ; lepp and gibson, ) . irresponsibility fi nds expression in several ways such as carelessness over food consumption, underestimation of dangers and a corresponding absence of preparedness and protection (casteli, ) . traffi c accidents and drowning account form a signifi cant proportion of deaths and injuries among international tourists (mcinnes et al., ) and many cases are attributable to thoughtlessness. drivers may be reckless, over-tired, insuffi ciently knowledgeable about local conditions, diverted by the passing sights, under the infl uence of alcohol and not using seat belts (wilks et al., ) . sexual activity is one important high risk area described in the next section, followed by an account of adventure tourism which can also be seen as a type of willing engagement with danger. some tourists may abandon their personal inhibitions when traveling and ignore norms to which they conform at home, thereby exposing themselves and those with whom they have contact to harm (wickens, ) . such an attitude applies to sexual adventures with a heightened chance of catching or perhaps communicating a sexually transmitted disease, including hiv/aids, unless appropriate precautions are taken. the hiv/aids epidemic has been linked to international travel and sex tourism based on prostitution, traffi cking in women and children and pornography is regarded as one vehicle for its spread. cheaper air fares and the marketing of more third world countries have favored sex tourism and the internet has also created more opportunities for tourists in search of sexual gratifi cation abroad, advertising adult and child pornography internationally. such tourism is now a worldwide phenomenon which has benefi ted from inadequate laws in certain regions, especially regarding the welfare of minors. studies of sex tourism emphasize its complexity and variety (bauer and mckercher, ; clift and carter, ) , sex tourists shown to exhibit contrasting expectations from lonely individuals seeking a holiday "romance" to more commercial relationships (oppermann, ) . provision also varies in terms of legality, offi cial regulation and conditions and attitudes of sex workers. the morality of adult prostitution and its capacity to demean the sellers of services are topics for debate, although the view of prostitutes as naïve and innocent victims of more powerful tourists has been contested (cohen, ; ryan and kinder, ) . nevertheless, all casual sex carries certain health risks for both parties. the participation of children cannot be defended and has been widely condemned for the physical and emotional damage it infl icts. a save the children report maintained that about two million children aged between three and in africa, south east asia, latin america and eastern europe are being used for sex. tourists come principally from france, italy, germany, belgium and spain and number about . million (the lancet, ) . it should, however, be remembered that customers are not confi ned to western tourists and include asians and local residents. opposition to such practices is intensifying and offi cial organizations and pressure groups are trying to raise awareness and encourage action by the tourism industry and governments. two examples are epcat (end child prostitution, child pornography and traffi cking of children for sexual purposes) and unescap (united nations economic and social commission for asia and the pacifi c). there have been some advances with signs of willingness in south east asia to deal more rigorously with the sexual exploitation of children and pursue court convictions for organizers and offenders. in terms of demand, there have been endeavors in the uk to restrict overseas travel by certain groups of known sex offenders. prosecutions can also now be conducted in the country of residence of the accused, not just where the alleged offences took place. the negative connotations of sex tourism, particularly child prostitution, may discourage visits by many tourists to destinations where it is known to be rampant. associated high rates of hiv/aids may also be a deterrent. locations which have acquired a seedy and unsavory image could have diffi culty promoting themselves to particular markets such as families, provoking a crisis for parts of the industry. one such example is thailand. the tat has been seeking to position the country as more exclusive with an emphasis on its natural and cultural heritage. at the same time, the authorities are faced with the realities of a thriving commercial sex sector in tourist hubs such as bangkok, pattaya, koh samui and chiang mai. the tat has tried to resolve this dilemma by publicly professing an abhorrence of sex tourism and its pursuit of the eradication of the worst excesses. it asks its overseas offi ces to report companies selling sex tours to thailand and claims to be enforcing the country's anti-prostitution laws, together with the police. these laws impose penalties of fi nes and imprisonment on customers, procurers, brothel owners and those forcing children into prostitution who are sometimes parents (tourism authority of thailand, ). an end to illegal and unregulated sex tourism in thailand and elsewhere is, however, problematic because of the economic rewards. it represents a major industry in some places and can be a vital source of income; for example, over % of young female cambodian prostitutes may be the principal family breadwinner. many commentators also question the commitment of offi cials to the drive against prostitution in general and involving children in particular. there is a lack of political will and changes will require immense effort. campaigns do not always receive the full support of the local police and other bodies, corruption being a major obstacle. sexual exploitation has socio-economic roots and is a product of poverty, lack of education and drug addiction. until these issues are addressed, it seems that the more unacceptable manifestations of sex tourism in the developing world will continue to thrive (bbc news, ; unescap, ) . adventure tourism is perhaps worthy of note as a kind of tourism in which participants deliberately search out danger, often taking part in what are described as "extreme sports." such forms of tourism are popular in australia, new zealand and north america and have seen worldwide growth in recent years (ryan, ) . there are a variety of motives for taking part and the concept of adventure is subjective, reaching beyond specifi c recreational pursuits to encompass more passive groups taking part in overland tours (weber, ) . however, the term usually applies to physically demanding activities such as caving, white water rafting, canyoning (the entering of gorges and body surfi ng without a raft down the rapids and waterfalls which fl ow through them), climbing, sea kayaking and horse riding. participants thus expose themselves to accident and injury, although these are unlikely to be welcomed or desired. a degree of organization and commercialization is implied and operators are expected to protect their customers from undue risk with an assumption that they have given proper attention to safety matters (bentley and page, ; hall, ) . it is impossible, however, to guarantee absolute safety and accidents do occur (see boxed case two). another tragedy happened in when two american divers died at sea after being mistakenly left behind on the australian great barrier reef (wilks and davis, ) . the skipper of the vessel concerned was later charged with manslaughter on the basis of criminal negligence. it is not just the major catastrophes which are of relevance; minor incidents such as "slips, trips and falls" account for many injuries and insurance claims (bentley et al., ) . again, events of this nature damage individual companies, the industry as a whole and possibly the destinations where they take place. authorities in new zealand have expressed concern over the number of adventure sports deaths there and the consequences they might have for tourist demand. there is thus great diversity in the characteristics and intensity of tourism crises arising from health and many cases of illness and personal accidents are limited in their scope and outcome. this makes any emergent crisis easier to manage, although instances such as the death of airline passengers from dvt or adventure holiday could pose serious challenges to particular businesses and destinations. other situations have the capacity to become major crises and this applies especially to disease which attracts intense media interest and may raise doubts about the competence of responsible authorities. travel is an agent of globalization which can assist in the dissemination of communicable disease and many destinations are inadequately equipped to meet the ensuing demands on health services. the tourism industry cannot ignore such developments as offi cials are predicting the recurrence and intensifi cation of epidemic-prone viral and bacterial diseases which do not respect territorial boundaries. there have also been warnings about a total of people, tourists and three guides, were killed in a fl ash fl ood in july . the accident happened on a canyoning trip near interlaken in central switzerland which had been organized by a swiss adventure company. the dead tourists, from to years of age, came from australia, britain, new zealand, south africa and switzerland and belonged to a larger party of tourists accompanied by eight guides. the guides failed to evacuate them from a gorge which fi lled with water during a fl ash fl ood and many were washed away. the trial in lasted seven days and was attended by the families and friends of the deceased. lawyers defending the company, which was then no longer in business, argued that the accident could not have been predicted and was the outcome of exceptional weather. those who survived claimed that arrangements had been rushed and there were no clear explanations. the judge said in court that employees had not been appropriately trained and safety procedures were completely unsatisfactory. the fatal trip should have been canceled as there had been clear warnings of a storm, the progress of which could easily be seen. he ruled that six staff members had been guilty of negligent manslaughter and declared two junior guides innocent. the three directors were fi ned us$ , and received fi ve-month suspended prison sentences while the three senior guides faced lower fi nes and reduced sentences. there had been an earlier trial involving the same company in when two staff had also been convicted of negligent manslaughter and received suspended sentences of fi ve months. the case related to the death of an american in his early s whose bungee jump cord was defective. the incident had contributed to the company's end. partly in response to these events, switzerland launched a code of conduct for extreme sports operators and introduced education programs for guides. source: bbc news, b. an increase in new infections and drug-resistant pathogens. in addition, there is the possibility of a coalescence of the threats to tourism from terrorists and ill health due to speculation that disaffected groups may gain samples of deadly viruses and toxic substances. these substances could then be employed as instruments of terror, perhaps specifi cally aimed at tourists, by such "bioterrorists." rampant infectious disease is not the only concern and there may be numerous other health risks at certain locations which are extremely attractive to tourists. transportation and some leisure activities also have inherent dangers. tourists and the industry will shun places where there is a known threat to visitor health, but may fi nd themselves caught up in unexpected events. coping with the worst of these situations is a daunting exercise for the tourism industry, but readiness is essential in view of the inevitability of health-related tourism crises. preventive steps can help to avert the evolution of a full-scale tourism crisis, but the industry has sometimes shown itself reluctant to deliver appropriate health warnings because of fears about scaring customers away and losing business (lawton and page, ; stears, ) . analysis of australian travel brochures (bauer, ) and international commercial travel websites (horvath et al., ) reveals that little useful information is provided and that which is available is insuffi cient. authors of these studies advise that customers should be fully informed about problems and advised to take precautions and purchase travel insurance. destinations could also be classifi ed on the basis of risk and overall awareness promoted through education. there are opportunities for greater collaboration between medical workers, health educators and the travel trade with advice and guidelines channeled by way of travel agents. specifi c information about sexually transmitted diseases can be distributed to tourists before departure, counseling about safe sex and condom use. in terms of child prostitution, the abuse of minors represents a crisis of ethics for the industry, which must acknowledge and act upon its responsibilities regarding the transgressions of customers. there has been some progress in this direction and epcat has cooperated with the french hotel group accor in an initiative against child prostitution in asia. it is also liaising with the wto to promote acceptance of a code of conduct among industry members (epcat, ) , although campaigners argue that much more needs to be done. with regard to accidents, travel health professionals can again try to educate the traveling public through material covering active and passive protection (hartgarten, ) . the industry has ethical obligations regarding the safety of its customers and there are additional legal reasons for giving due regard to health and safety matters. the european commission directive on package travel, for example, insists that travel organizers and agents must provide health and safety details for their clients and may be liable for any harm they suffer. some initiatives to minimize unnecessary dangers and avoid serious injuries in the fi eld of adventure tourism are operator accreditation schemes, strict health and safety rules, codes of conduct, staff training and the education and prior assessment of participants (bentley and page, ) . risk management is also critical (wilks and davis, ) . such moves are still voluntary in most countries and statutory regulation might be deemed imperative, extending to other areas such as general road safety. it is unfortunate that tragic loss of life, such as that in switzerland, is often the catalyst for long-overdue reforms. promoting a culture of safety would also reduce the number of more common minor incidents (bentley et al., ) which collectively constitute a crisis. the industry can also cooperate with destination authorities in upgrading utilities and public services for the benefi t of the whole community. investment in water supply and sewage disposal facilities would alleviate sickness arising from poor hygiene and training in food handling and regular inspection and monitoring of premises could be introduced. many countries lack basic health-care provision and priority should be allocated to improving the lives and health of residents as well as to meeting tourist needs, an approach in correspondence with the philosophy of sustainable tourism development. such displays of corporate social responsibility will assist in reducing the likelihood of another type of crisis, those derived from resentment toward tourists among residents when the former are believed to be receiving preferential treatment. action is thus required at a company and industry level, with governments and tourists also having a vital contribution to make. the wto has stressed the significance of health as an aspect of tourist safety and proposes that member states pursue the following program to enhance their capabilities in dealing with diffi culties (wto, ) : identifi cation of risks to tourists related to particular activities, locations and sites. introduction and strict enforcement of safety standards and practices at facilities and venues. establishment and distribution of operator guidelines. provision of information to the public about possible health hazards, protective steps and sources of assistance. proper staff education and training. clarifi cation of liability issues and formulation of rules and regulations. development of national tourism health policies, including systems of reporting to inform the international community. at a caribbean tourism organization seminar (cto, ) , a wto representative cited four critical considerations pertaining to the effective handling of health crises. they were the allocation and acceptance of responsibilities, transparency, assistance mechanisms and management of fear. the tourism sector was urged to improve its responses by being more proactive and there were calls for greater global cooperation. eradication or minimization of both health and safety risks at resorts is a collective effort involving stakeholders of owners, operators, staff, visitors, offi cials and medical experts (phillip and hodgkinson, ) . however, some damage to tourism is to be expected even when such systems are in place. sars, and to a lesser extent foot and mouth, overwhelmed the industry, which had little scope to react or room for maneuver. tourism was at the mercy of the epidemic dynamics and initiatives to generate business were thus constrained. it was only when the health crisis abated that advertising campaigns and product development started to yield signifi cant results, although discounting and a focus on domestic markets did generate some revenue prior to the onset of recovery. questions of health therefore represent a potential source of tourism crises, although their severity varies considerably. the magnitude of any crisis will depend partly upon the numbers involved and whether there are any fatalities, dimensions which determine the amount of publicity generated. media coverage is a critical infl uence on popular opinion and handling external communications is a core element of crisis management. the examples cited in the chapter suggest that prompt efforts to enhance safety and security systems following a critical incident are essential to demonstrate a commitment to safeguard tourists and inspire confi dence that the event will not be repeated. matters of compensation also need to be resolved in a fair manner and this is related to questions of liability and obligations to next of kin when there have been fatalities. negligence must be seen to be punished and companies to make amends for their shortcomings if an organization and its reputation are to survive the crisis. these issues are returned to in chapter , which deals with transport accidents as an illustration of technological failure. health is perhaps an arena of crisis which is more amenable to avoidance than some others. while certain contagious diseases and their progress are unpredictable and uncontrollable, the likelihood of other illnesses and accidents occurring may be minimized by increased awareness, changed behavior and better hygiene and safety standards. these goals are easier to achieve within controlled environments such as cruise ships, individual hotels, attraction sites and aircraft cabins, but are more formidable and costly tasks for destinations. the latter cannot be left to the tourism industry alone, but demands intervention by governments and relevant international agencies as well as responsible behavior from tourists themselves. medical reports indicate that as many as % of long-haul fl yers could be at risk from dvt, or so-called "economy class syndrome." some experts believe that sitting for long periods in the cramped seating of an aircraft cabin encourages the formation of blood clots in the legs which can break away and travel to the lungs, leading to potentially deadly pulmonary embolism. there may also be a relationship between reduced cabin air pressure and blood oxygen which could promote dizziness, nausea and fainting on long-haul fl ights. several victims of dvt and their families have sued airlines, contending that air travel caused the malady. american airlines, united airlines, delta, northwest, japan airlines, qantas, singapore airlines, british airways, klm and virgin air were among a total of carriers named in a lawsuit. a london court concluded that blood clots were a "serious personal injury" and could not be defi ned as an "accident" under the warsaw convention; the treaty recognizes that airline liability regarding damages applies only to the latter. the supreme court in the australian state of victoria, however, decided in favor of the plaintiffs in a parallel case, permitting a landmark lawsuit to proceed. american airlines, the world's largest carrier, reportedly reached an out-of-court settlement in a blood clot dispute at the end of . analysts were watching for any court judgment in the united states where the award of damages would probably be very high and perhaps set a precedent. following the london ruling, british airways said that it sympathized with dvt sufferers. however, it also stated its belief that any link with air travel was uncertain and this would inform its position on other claims. it had, nevertheless, introduced a new manual of infl ight medical care in late to assist crew in looking after passengers who became ill during fl ights. the manual provided instructions on dealing with many scenarios and was complemented by staff training and a cd-rom version, the company's intranet used for additional training purposes. these materials are supplemented by a telephone link to a -hour advice center on the ground. other measures to minimize the risks of dvt had been in operation for some time. sources of information and advice included the corporate website, phone lines, in-fl ight videos and magazines and ticket wallets. a healthy journey leafl et recommended that passengers drink plenty of fl uids, eat moderately and limit their intake of alcohol and caffeine. they were also advised not to remain seated for the whole of a long-haul fl ight and appropriate exercises were suggested. it was announced in early that british airways would be cooperating with the medical school of birmingham university in a study of dvt. travelers drawn from a sample of about , members of its frequent fl yer loyalty program were to be surveyed. respondents would be asked about any precautions they took regarding dvt, attitudes toward the disease and extent of alarm. it was considered a signifi cant step, being the fi rst occasion that a british airline had been willing to participate directly in such a research project. the company's support for the research study was welcomed, especially as there had been reports that a similar world health organization (who) project was facing funding problems. critics and campaigners had been arguing that the industry was refusing to acknowledge dvt risks and evading its responsibilities regarding informing passengers. reporters suggested that britain's airline industry was anxious to avoid any further damaging news stories about deaths resulting from fl ying in the aftermath of september. sources: bbc news, a; the observer, ; one news, ; travel telegraph, . a new virus which initially surfaced in the south of china in was given the name of severe acute respiratory syndrome (sars). it is a type of pneumonia which seems to be transmitted by vapor droplets and close personal contact, although little was known about its characteristics in the early months. while knowledge has subsequently increased, there is still no vaccine or cure and control depends upon the rapid identifi cation of sufferers and their isolation. any people they have been in association with also need to be quarantined in order to interrupt transmission. authorities in china were caught by surprise and slow to inform the international community about the disease so that preventive measures were not taken immediately. infected travelers were thus free to carry the virus abroad to locations such as toronto in canada, hong kong, singapore, taiwan and vietnam. these locations recorded the highest numbers, but there were isolated cases found elsewhere in countries altogether. despite fears of a global pandemic, the virus proved less contagious and fatal than originally feared and the outbreak had essentially ended by mid- . there had been a total of , infections and deaths, the majority of these in asia. initial ignorance and the speed at which sars was advancing created great anxiety and a degree of panic among resident populations and tourists. governments and international agencies such as the who identifi ed places affected by sars and advised against visits to where it was spreading in the community due to risks of contraction. the who intervention was unprecedented and its pronouncements carried considerable authority. offi cials were concerned about the importation of the disease and inbound arrivals from sars states were monitored. the who also recommended certain procedures for airlines and airports to follow and sars came to be associated with air travel, with some airline crew donning face masks. the virus dominated the headlines in much of asia and received extensive publicity around the world. the media broadcast disturbing accounts of a mysterious deadly illness on the rampage and pictures of deserted streets and locals wearing masks. tourism was immediately affected as people were unwilling to travel, especially by plane, for fear of catching sars. the worst hit areas were shunned by inbound tourists and outbound travelers faced various restrictions. countries saw falls of over % in arrivals during the worst months and there was also a slump in domestic tourism and consumer spending in general. the transport, accommodation, attraction and retail sectors all lost business and the survival of some companies was threatened. recovery was dictated by the progress of the epidemic and the lifting of the who travel advisories was a major turning point for individual countries. nevertheless, worries about a return of the virus persisted and fi gures for the year were depressed with declines of . % for china, . % for hong kong, . % for taiwan and . % for singapore. the wttc estimated that the industry's contribution to gdp would drop by . % in china, . % in hong kong and % in singapore. vietnam had only cases and fi ve sars deaths, all confi ned to a hanoi hospital, but tourism there too was forecast to be worth . % less in terms of its gdp contribution. the reverberations were felt in countries where there were very few or no cases of sars such as thailand and the contraction in travel throughout the asia pacifi c region of . % in was attributed to the outbreak. outside asia, toronto was estimated to be losing c$ every day in april due to the cancellation of major conventions. there was a common pattern of reaction among offi cial institutions and private enterprises which included the gathering and communication of information, marketing aimed at reassurance, efforts to sell to domestic markets, price cutting, a search for cost savings and greater effi ciency, rationalization, capacity reduction and staff redundancies. a great deal of attention was also given to the devising and implementation of health and safety regimes designed to convince customers that the industry was prepared and particular sites were safe. governments were also active in support of tourism businesses and in initiatives to enhance standards of public hygiene. it proved very diffi cult to combat the adverse impacts of sars when it was still spreading and even after it had been contained, but marketing efforts were intensifi ed when places had been formally declared free of sars. the who announcement was the occasion for re-launching affected destinations such as hong kong and singapore in a bid to generate maximum publicity. sources : euromonitor, ; henderson, ; mckercher and chon, ; who, ; wttc, . adventure tourism: a form of tourism involving participation in physically demanding activities which expose the tourist to risks of injury. economy class syndrome: another name for dvt (deep-vein thrombosis), potentially lethal blood clots which may be caused by seating conditions in commercial passenger aircraft. sex tourism: tourism in which the primary motivation is the satisfaction of sexual needs, often met by prostitutes and seen as a source of sexually transmitted disease. tourist health risks: factors and forces which threaten the physical and psychological well-being of tourists. . what preventive strategies can be employed by the tourism industry regarding the contracting of illness and disease by tourists and what will their success depend on? . have airlines responded appropriately to the risks of dvt among passengers? . was there an over-reaction to the threat of sars by tourists and the tourism industry in generating countries and could this have been avoided? additional readings castelli, f. ( ) . human mobility and disease: a global challenge. journal of travel medicine, ( ) in what ways are issues of health a major concern for the tourism industry? . what are the principal types of health-related crises that accommodation how do health questions impact on the work of destination marketing organizations? health advice in australian travel brochures the health of host communities: missing from printed travel health advice sex and tourism: journeys of romance, love and lust asia's child sex tourism rising airlines face legal action over dvt scoping the extent of adventure tourism accidents the safety experience of new zealand adventure tour operators disease daunts tourism tourists' and travellers' social construction of africa and asia as risky locations human mobility and disease: a global challenge vessel sanitation program tourism and sex: culture, commerce and coercion tourism and health: risks, research and responses health and the international tourist open-ended prostitution as a skillful game of luck: opportunities, risk and security amongst tourist-oriented prostitutes in bangkok trends in travelers tourism sector responsiveness to health crises tourists' health: could the travel industry do more? tourism management annual report travelers' diarrhea travel and tourism in canada uk tourism : open for business cruise ship health alert exaggerated, say passengers adventure, sport and health tourism injury prevention: a crucial aspect of travel medicine managing a health-related crisis: sars in singapore travel health information at commercial travel websites foot and mouth crisis hits hotels in the veluwe food safety in the st century travel medicine spain makes plan to combat sex tourism evaluating travel agents' provision of health advice to travellers tourist roles, perceived risk and international tourism unintentional injury during foreign travel: a review the over-reaction to sars and the collapse of asian tourism medical problems in cycling tourism ba hauls in fl yers to check dvt risk one news website at http: onenews.nzoom.com/onenews sex tourism tourist accidents: an exploratory analysis the management of health and safety hazards in tourist resorts. world tourism organization the health-development link: travel as a public health issue off the beaten track: the health implications of the development of special interest tourism activities in south east asia and the south pacifi c linkages between holiday taking travel risk and insurance claims: evidence from new zealand sex, tourism and sex tourism: fulfi lling similar needs? tourism management urban medicine: threats to health of travelers to developing world cities focus on cruise ship travel travel-associated infectious diseases life and death on the amazon: illness and injury to travelers on a south american expedition travel health promotion: advances and alliances incidence of health crises in tourists visiting jamaica, west indies tat supports fi ght against child prostitution select committee on culture, media and sport. tourism-the hidden giant-and foot and mouth united nations economic and social commission for asia and the pacifi c website at outdoor adventure tourism: a review of research approaches health risk-taking and tourism risk management for scuba diving operators on australia's great barrier reef international tourists and road safety in australia: developing a national research and management programme international travel and health. geneva: world health organization avian infl uenza recommended measures for tourism safety madrid: world tourism organization principles and practice of travel medicine key: cord- -xjnbmah authors: van goethem, n.; struelens, m. j.; de keersmaecker, s. c. j.; roosens, n. h. c.; robert, a.; quoilin, s.; van oyen, h.; devleesschauwer, b. title: perceived utility and feasibility of pathogen genomics for public health practice: a survey among public health professionals working in the field of infectious diseases, belgium, date: - - journal: bmc public health doi: . /s - - - sha: doc_id: cord_uid: xjnbmah background: pathogen genomics is increasingly being translated from the research setting into the activities of public health professionals operating at different levels. this survey aims to appraise the literacy level and gather the opinions of public health experts and allied professionals working in the field of infectious diseases in belgium concerning the implementation of next-generation sequencing (ngs) in public health practice. methods: in may , belgian public health and healthcare professionals were invited to complete an online survey containing eight main topics including background questions, general attitude towards pathogen genomics for public health practice and main concerns, genomic literacy, current and planned ngs activities, place of ngs in diagnostic microbiology pathways, data sharing obstacles, end-user requirements, and key drivers for the implementation of ngs. descriptive statistics were used to report on the frequency distribution of multiple choice responses whereas thematic analysis was used to analyze free text responses. a multivariable logistic regression model was constructed to identify important predictors for a positive attitude towards the implementation of pathogen genomics in public health practice. results: out of the invited public health professionals completed the survey. % of respondents indicated that public health agencies should be using genomics to understand and control infectious diseases. having a high level of expertise in the field of pathogen genomics was the strongest predictor of a positive attitude (or = . , % ci = . – . ). a significantly higher proportion of data providers indicated to have followed training in the field of pathogen genomics compared to data end-users (p < . ). overall, % of participants expressed interest in receiving further training. main concerns were related to the cost of sequencing technologies, data sharing, data integration, interdisciplinary working, and bioinformatics expertise. conclusions: belgian health professionals expressed favorable views about implementation of pathogen genomics in their work activities related to infectious disease surveillance and control. they expressed the need for suitable training initiatives to strengthen their competences in the field. their perception of the utility and feasibility of pathogen genomics for public health purposes will be a key driver for its further implementation. sequence information from viruses, bacteria, and other infectious organisms can be used to identify a pathogen and its specific characteristics, and compare its genetic relatedness to other pathogens [ ] . advances in sequencing technologies, especially the shift to next-generation sequencing (ngs), have made it possible to analyze pathogen genomes in much greater detail. compared to sanger sequencing, ngs technologies allow a faster and cheaper way to sequence larger lengths of nucleotides. as such, ngs makes microbial pathogen whole-genome sequencing (wgs) accessible in high throughput within a matter of days [ ] . during the last decade, ngs has expanded beyond the research settings and is being rapidly applied into routine practice for public health and food safety [ ] [ ] [ ] [ ] [ ] [ ] . in public health, integrating pathogen genomics with epidemiology provides many opportunities for improving the population-level risk assessment and management of infectious diseases [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the main applications of wgs include ( ) retrospective (or near real-time) comparisons of pathogens' relatedness to test epidemiological transmission hypotheses of suspected outbreaks (i.e. outbreak investigations); ( ) wgs-based prospective surveillance by monitoring of cases generating alerts when clusters of pathogens with similar genomes are identified in a limited geographical area or time period or when virulent clones emerge (outbreak detection by control-oriented surveillance); and ( ) cross-sectional genomic epidemiology surveys to monitor long-term changes in epidemiology over larger geographic and population scales to inform prevention strategies (strategy-oriented surveillance) [ ] . the main added value of implementing wgs during surveillance activities or outbreak investigations is inherent in the higher resolution of the wgs output itself, leading to an increased sensitivity and specificity to identify transmission clusters compared to conventional subtyping methods [ ] . as such, there are numerous success stories of outbreak investigations applying wgs that were able to identify to the source of infection and implement targeted control measures to stop further spread, saving resources at the health protection and local authority level [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . other concrete examples of the utility of wgs for national surveillance and local infection control include the guidance of vaccination strategies [ ] [ ] [ ] [ ] and antibiotic stewardship [ , ] . besides transforming the public health approach to infectious diseases monitoring, analysis of pathogen genomics can advance the accuracy of infection diagnostics and guide the treatment of individual patients [ , [ ] [ ] [ ] [ ] [ ] [ ] . for several pathogens, ngs is able to replace current time-consuming and/or laborintensive conventional methods with a single, all-in-one diagnostic test [ ] [ ] [ ] [ ] . public health professionals play a key role in protecting the population against communicable disease threats. this requires them to give effective responses in a limited time frame, supported by adequate information resulting from applying the most appropriate tools adapted to the specific public health threat scenario. infectious disease surveillance systems build upon the cooperation between: clinicians, who are at the frontline through identification of infected patients; microbiologists, who are involved in testing specimens; molecular biologists, who study organisms at the molecular level; bioinformaticians, who develop computational approaches/algorithms to analyze genomic data; epidemiologists, who use the data to understand patterns in disease occurrence at the population level; infection control practitioners, who are responsible for local prevention and control of infectious diseases in the community; hospital hygienists, who are involved in the prevention and control of healthcare-associated infections; food safety inspectors, who monitor food products; etc. the activities of these public health experts operating at different levels in the information cycle will be impacted by the introduction of pathogen genomics as they are all connected to each other. this ranges from microbiologists adapting their laboratory workflows to epidemiologists rethinking their current data analysis approaches. typically, new laboratory technologies are adopted by data providers first, while data end-users might not be familiar enough with the new methods to effectively translate the output data into public health actions. expertise with pathogen genomics and its applications for public health practice might also differ between those in charge of national surveillance of infectious diseases and those involved in local infection control and patient management, as well as between different fields (i.e. human, animal, food, and the environment) within the one health spectrum [ , ] . differences in perceptions and needs between these different profiles should be taken into account before we can build a strategy that engages all the stakeholders in an effective collaboration. the key to success in translating pathogen genomics into public health practice is to demonstrate an added value by better addressing the needs and expectations of the whole range of public health experts. an effective exchange of expertise across disciplines (e.g., clinicians, microbiologists, epidemiologists, and bioinformaticians) is key for enabling the smooth implementation of ngs into routine public health activities. if such coordination of joint efforts cannot be accomplished, the technology shift, which is currently ongoing, might not realize its full potential [ , ] . previous surveys in the field of public health genomics focused on: human genomics [ ] [ ] [ ] ; specific aspects such as proficiency testing [ ] , the design of wgs clinical reports [ ] or data sharing [ ] ; or specific target groups such as national microbiology focal points [ ] or food safety laboratories [ ] . in this study, by organizing an online survey, we aimed to perform a wide landscape analysis of all potentially involved stakeholders in order to appraise the level of genomic literacy and to gather the opinions of public health experts and allied professionals working in the field of infectious diseases in belgium concerning the implementation of ngs in routine public health activities, in terms of its utility, feasibility, implementation, and translation into actionable results for public health decision making. an electronic questionnaire survey (see additional file ) was developed for this study using limesurvey (version . . ) [ ] for the collection of relevant information from public health professionals working in the field of infectious diseases in belgium. for the purposes of this study, a 'public health professional in the field of infectious diseases' was defined as a person with professional expertise in the field of infectious diseases and who directly or indirectly contributes to the population-level management of infectious diseases. to provide a complete picture of all involved stakeholders, the survey aimed to reach different subgroups based on professional qualification (i.e. microbiologists, molecular biologists, bioinformaticians, epidemiologists, clinicians, clinical biologists, infection control practitioners, and hospital hygienists), employing institution (i.e. governmental, private, hospital, and university), health field (i.e. human, animal, food, and environment), expertise in pathogens (i.e. bacteria, viruses, parasites, fungi, and yeasts), and level of action (i.e. national surveillance and local infection control). to identify all actors in the field of public health activities for infectious diseases, an overview was made of existing surveillance systems (i.e. data sources) in belgium (see additional file ). the set of questions was compiled based on the literature, including several review articles [ - , , , - , , ] . existing items from previous survey questionnaires [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] ) were used and adapted when relevant. most of the existing questionnaires from which some questions were adapted to be used for this survey were not validated, except for chow-white et al. as mentioned in the respective publication [ ] . the construction of the survey was discussed during several feedback rounds within a multidisciplinary team including epidemiologists, microbiologists, and molecular biologists. as a result, the survey instrument was vetted by subject matter experts. the questionnaire eventually contained eight main topics comprising background questions, general attitude towards pathogen genomics for public health practice and main concerns, genomic literacy, current and planned ngs activities, place of ngs in the diagnostic hierarchy of microbiology, data sharing obstacles, end-user requirements, and key drivers for the implementation of ngs. based on a filter question where participants indicated their level of familiarity with pathogen genomics, the respondents were redirected to different sets of questions with different levels of technicity and detail. the filter question gave access to a reduced version of the questionnaire for those participants judging themselves as not at all familiar with pathogen genomics. the responses were mainly collected as single/multiple options from a set of pre-defined answers, but also included the optional entry of free text. these qualitative open questions were included to add context to the quantitative responses. the survey tool was pre-tested by three researchers not directly involved in the development phase to ensure the acceptability and clarity of the questionnaire. participants were contacted individually by an email invitation containing a personal token to complete the survey. no monetary or other incentive was offered. the participant information statement at the beginning of the survey informed the respondents about the objective and design of the study and their rights before participation to the survey, and explained that responses are anonymized and will be kept confidential. the approval from an ethical committee was not considered necessary due to national regulations (legislation april ), as this study was not medical in nature and as participants were not subject to any actions and/or rules of conduct. the survey was available online during a two months' period during which three reminders were sent to those who had not yet responded. the first invitations were sent on the th of may and the survey remained active until the st of july . participants were invited to send any questions, feedback or comments for the survey to the organizers. only completed questionnaires were used for analysis. descriptive statistics were reported by analyzing categorical response frequencies. differences in viewpoints between the stakeholders were described using subgroup analyses and compared using a fisher's exact test. subgroups were compiled on the basis of the level of action (national vs. local), the position in the information cycle (data providers vs. data end-users), and the level of expertise in the field of pathogen genomics. the level of action was considered national when the main affiliation of the respondent concerned a national institute involved in national public health activities, whereas the local level included professionals who mainly operate at the community, hospital, or university level. subgroups based on the position in the information cycle were defined as data providers, defined here as experts in wet and dry lab procedures and (potentially) generating ngs data (including microbiologists, molecular biologists, clinical biologists, and bioinformaticians), and data endusers defined here as using ngs data to improve their activities and implementing infection control measures (including epidemiologists, local infection control practitioners, hospital hygienists, and clinicians). the level of expertise was categorized as high, middle or low, and was based on respondents' self-reported familiarity with pathogen genomics, training level, and current use of ngs. multiple logistic regression was performed to identify predictors of a positive attitude towards the implementation of pathogen genomics from a public health perspective. enthusiasm about public health agencies using genomics to understand and control infectious diseases was defined directly through a question with multiple options, each containing a clear statement (see additional file ). for the purpose of this analysis, the question asking about their enthusiasm originally consisting of multiple categories was collapsed into two levels: very enthusiastic versus all others. the following predictor variables were initially tested in the model: level of action; position in the information cycle; level of expertise; current use of ngs; institution; age group; years of professional experience; and position in their institution. model building involved a univariate analysis to select variables to be included in the multivariable model based on a χ -test (cut-off, p = . ), and variable selection from the multivariable model using backward stepwise regression based on the akaike information criterion (aic). adjusted odds ratios (ors) and % confidence intervals (cis) were calculated. quantitative analyses were performed using r software (r studio version . . ) [ ] . answers to open-ended survey questions were summarized and analyzed using nvivo qualitative data analysis software (nvivo version ) [ ] . this was done by identifying themes (codes) within the data, which were derived both deductively and inductively. following the thematic analysis framework, the text was compared and contrasted with the identified codes. the qualitative findings were summarized as a mind map linking the identified major and minor themes and a word cloud visualizing the word frequency from the qualitative responses. simultaneously, quotes were selected for the sake of illustration. out of the invited participants, did not respond at all, partially filled in the survey, and a total of participants delivered a completed survey which represents an overall survey response rate of % (fig. ). from these, participants continued after the filter question and delivered answers to all questions ( subject were redirected to a technical version of the survey and subjects to a basic version, based on the filter question). the data from the participants who preferred to quit after the filter question were only used to describe the background characteristics of the study population. the subjects who partially filled in the survey were dropped completely from the analysis. full responses to all questions as they appeared in the questionnaire are provided as an appendix to this report (see additional file ). background characteristics of the participants are presented in table . the majority of respondents had their main affiliation in the public sector ( %), followed by hospitals (including university hospitals) ( %), private sector ( %), and university ( %). the public sector was primarily represented by sciensano (belgian institute for health), comprising % of all survey participants ( / ). % of the respondents indicated that they had more than years of professional experience within the field of infectious diseases. the reported roles of respondents within their institutions included: microbiologists/molecular biologists/bioinformaticians/clinical biologists ( %); epidemiologists ( %); clinicians ( %); hospital hygienists/infection control practitioners ( %); and policy makers ( %). the survey respondents were asked to describe their level of familiarity with sequencing technologies and pathogen genomics using following classification: 'very -i am involved in the generation and/or use of ngs data' ( %), 'somewhat -i have a general sense of the applications of ngs' ( %), or 'not at all -i don't know anything about ngs and its applications' ( %). of those participants answering 'very familiar', most of them ( %; / ) indicated that they mainly used ngs in the context of wgs. of those 'not at all familiar', preferred to quit the survey and continued the survey to answer some general questions, leaving a total of participants for the remainder of the survey (fig. ) . subgroup analysis showed differences in familiarity with pathogen genomics between data providers and endusers (fig. ). data providers indicated significantly more frequently that they were 'very familiar' compared to data end-users (p < . ). the majority of respondents ( %; / ) indicated that they were very enthusiastic (i.e. 'we should be using genomics now') about public health agencies using genomics to understand and control infectious diseases, % ( / ) did not have an opinion or did not know enough of the topic to be able to give an opinion, and % ( / ) indicated that they did not see clear applications and/or an added value for public health. subgroup analysis pointed out differences in enthusiasm according to the level of expertise in the field of pathogen genomics ( fig. ). important predictors, as identified by the best fitting model, of a positive attitude related to the implementation of pathogen genomics from a public health perspective were the level of expertise, the level of action, and the position in the information cycle ( table ). participants classified as having a high level of expertise based on their self-reported familiarity with the topic, their training level, and/or the current use of ngs were significantly more likely to be enthusiastic about the implementation of pathogen genomics in a public health context compared to their peers with a low expertise (adjusted or = . , % ci = . - . ). further, public health professionals operating at the national level were more often 'very enthusiastic' about the implementation of pathogen genomics ( %) compared to those at the local level ( %). similarly, data providers were more often 'very enthusiastic' ( %) compared to data end-users ( %). a large majority of respondents considered the following public health activities as likely to be most impacted by pathogen genomics in the next five years: identifying an outbreak (clusters of related isolates) ( %; / ), nosocomial and food/waterborne outbreak investigations ( %; / ), and monitoring the spread of antimicrobial resistance ( %; / ). in contrast, only % ( / ) of respondents thought that pathogen genomics would have a major impact on making a diagnosis and selecting an appropriate treatment (individual patient management). other public health activities that will benefit from the implementation of pathogen genomics mentioned by the participants are presented in table . the most frequent concerns among participants being 'very' or 'somewhat' familiar with ngs technologies and pathogen genomics (n= ) regarding feasibility of its routine use for public health purposes, were the cost of sequencing technologies and the existing barriers to timely and open sharing of pathogen sequence data and accompanying metadata ( table ). all participants exclusively working with respiratory infections (e.g. influenza) and/or vaccine-preventable diseases (e.g. measles) (n= ) were very concerned about the cost, whereas this was only true for % of participants exclusively working with invasive bacterial diseases (e.g. neisseria meningitidis), food-and waterborne diseases (e.g. salmonella), and/or healthcareassociated infections (e.g. clostridium difficile) (n= ). further, other concerns shared by a large proportion of the participants were interdisciplinary cooperation, integration of pathogen sequence data with contextual data, access to bioinformatics expertise, and availability of typing schemes and databases. participants indicating to be 'not at all' familiar with pathogen genomics were mainly concerned about the cost of the sequencing technologies (see full responses in additional file ). other concerns provided by the participants as free text are presented in table . two-thirds of the participants ( / ) indicated that they had followed training in the fields of genomics/genetics/ molecular biology/bioinformatics. there were marked differences by position in the information cycle: % ( / ) of data end-users indicated that they had never followed any training in the field, whereas this was stated by only % ( / ) of data providers (p < . ). further breakdown of training experience by professional category is shown in fig. . the main reasons for not taking a training/course in this field (yet) were the lack of available and/or suitable trainings ( %; / ) and the lack of time ( %; / ). other reasons indicated as free text are presented in table . the vast majority of participants ( %, / ) indicated that they felt the need and/or would be interested in following (additional) courses/training/workshops covering a topic related to pathogen genomics. overall, % ( / ) participants being 'very' or 'somewhat' familiar with ngs technologies and pathogen genomics indicated that they are currently using or generating ngs data for at least one pathogen. differences between professional groups are presented in fig. . among the microbiologists, those from a national reference centre (nrc) were more likely to be currently using ngs ( / , i.e. %) compared to those from other laboratories ( / , i.e. %), however this difference was not significant (p= . ). from the public health professionals exclusively involved in human infectious disease activities, % ( / ) were currently using ngs technologies, whereas this was the case for % ( / ) of those exclusively involved in the food, animal or environmental sector (p= . ). looking forward, % ( / ) of participants indicated that they were planning to use or generate ngs data for any (additional) pathogen(s) within three years. details on the specified pathogens can be found in the appendix (see additional file ). reasons provided by participants indicating that they did not plan to implement pathogen genomics were mainly related to the cost and the lack of expertise. participants being 'very' or 'somewhat' familiar with ngs technologies and pathogen genomics (n= ) were asked to assign a score from to to the different criteria based on their increasing relative importance to decide whether or not ngs should be implemented for a particular pathogen (fig. ). clinical and/or public health significance of the pathogen were scored as the most important drivers. the different subgroups scored the different criteria similarly (see additional file ). comments provided by the participants to provide context to their scores are presented in table . centralization of sequencing and bioinformatics at nrcs organized per pathogen or per group of pathogens was most often ( %; / ) selected by respondents being 'very' or 'somewhat' familiar with pathogen genomics as the preferred wgs provision model in the belgian context. excluding participants working at nrcs slightly lowered this proportion to out of (i.e., %). there were no marked differences according to the level of action of the participants (fig. ) . illustrative quotes for the need for centralization are presented in table . public health activities, other than those provided within the survey, that will benefit from the implementation of pathogen genomics environmental monitoring "drinking water quality" "air quality, home environmental quality" metagenomics "metagenomics for patients with no identified cause of illness using conventional methods" "identification and characterization of new strains" "insights in dysbiosis" "microbiome analysis" other "discovery of a causal relation between a pathogen and a clinical disease (e.g. cancer)" "vaccine development" "phage therapy" "early diagnostics of diseases due to slow growing pathogens" "international tracking" "monitoring of antiviral resistance" concerns, other than those provided within the survey, related to the implementation of pathogen genomics for public health practice contextual data "harmonization of epidemiological datamost of the epidemiological data is very 'messy' or inconsistent, which makes systematic integration and surveillance unfeasible" "data collection is already limited so newer technologies will not automatically improve this process but be redundant if the basics are not met" "how to interpret the result at clinical level" "[…] they need to have a basic understanding (education) it order to understand and see cost/benefit of the whole picture" "appropriate training of personnel for execution and interpretation" "interpretation across sectors" "multidisciplinary knowledge" ethics "[…] healthcare workers integrity concerns" "in the hiv field, the phylogenetic analyses of virus permit to have an hindsight in paths of transmissionit is a very tricky topic in ethical and potentially legal aspects" other "does the identification prove that the pathogen poses a risk?" "the fear that some actors in the field will try to abuse their power and monopolize this new technologyto be really valuable to patient management and public health it is required to offer access to all laboratories" "high inter-laboratory variability" "[…] standardization and facilities for data sharing need to be improved" "the perceived utility and feasibility of pathogen genomics by public health practitioners is the biggest bottleneck of allall the other concerns listed above can be tackled given the drive within the field to solve them in the first place" reasons, other than those provided within the survey, for not taking a training/course in the field of pathogen genomics "lack of training adapted to public health needs" "not applicable for a clinician" "not my priority" "not relevant for my practice" "depends on the evolution in phenotypic typing" "[…] the main driver the pressure by ecdc rather than a real need for public health […] the first and main driver should be clinical significance: improve quality of care for the patient" "for bacteria, ngs will never fully replace classical methods for resistance testing, but would offer important complementary data" "cost-effectiveness (e.g. replacing multiple tests): not particularly true for viruses, but obvious for bacteria" centralization "[…] should be overall coordinated and controlled by the federal public health authority" "[…] in any scenario it will be important that sequence data are brought together in one databank for surveillance purposes" table . major themes identified within the qualitative data are utility (applications), feasibility (including capacity building, multi-disciplinary working, contextual data, costs, data sharing, ethics, timeliness, wet and dry lab), one health context, and routine implementation (including organization and translation into action). a mind map linking the identified major and minor themes is presented in fig. . a full list of identified themes and the coded text is available in the appendix (see additional file ), as well as a word cloud constructed based on the free text responses (see additional file ). this survey sought the opinion of belgian public health professionals working in the field of infectious diseases concerning the implementation of pathogen genomics in public health activities. to successfully translate pathogen genomics into public health practice, the needs and expectations of the different stakeholders should be taken into account. other questionnaire surveys related to knowledge and attitudes towards public health "the bureaucracy involved in the transmission of data" "the structure of public health in belgium will not help sharing data" "the required technical infrastructure" priority to publication "it is really a pity that priority to publication is an obstacle in the scientific world as it functions now" one health "a better collaboration between the veterinary and human side might increase the use of ngs on the veterinary side" "monitoring the emergence and spread of zoonotic pathogens has been impacted negatively, by the introduction of wgs at the human side only" genomics in specific health expert categories have been published [ , - , , , , ] . however, to the best of our knowledge this survey is the first that aimed to perform a wide landscape analysis of all potentially involved stakeholders. therefore, a strength of the current study is that it took into account a wide range of stakeholders with diverse backgrounds (epidemiologists, microbiologists, bioinformaticians, clinicians, infection control practitioners, etc.), health domains (human, food, environmental, etc.), pathogen expertise (bacteria, viruses, parasites, fungi, etc.), activity sectors (public, private, university, hospital, etc.), work positions (employee and lower/middle/high management), and degree of familiarity with genomics. besides seeking the general attitude of the participants towards the implementation of pathogen genomics in their professional activities and investigating the current and future use, this explorative study was able to touch upon multiple key topics, such as genomic literacy, data sharing obstacles, place of ngs in the diagnostic hierarchy of microbiology, and enduser requirements. familiarity with sequencing technologies and pathogen genomics varied between the different professional groups, with data providers being more familiar than data end-users. as shown before, one of the largest barriers to acceptability from the public health unit is the capacity to understand and use the data [ ] . possibly, there is a positive association between genomic literacy criteria could be assigned a score from to , or participants could indicate the 'i don't know' option. the boxplots show the median score and the interquartile range (grey boxes). the following criteria were included (top to bottom): clinical and/or public health significance, priority with respect to preventing the spread of antimicrobial resistance, local/national/international policy surveillance priorities or obligations, importance of prevention and control programs (e.g. vaccination), utility of wgs for diagnostics and/or treatment decisions (individual patient care), utility of increased resolution to infer relatedness that would not be obtained via conventional methods, availability of high-quality/complete/standardized epidemiological and/or clinical data to provide context to the wgs results, possibility to link genomic data from different sources (food-animalhuman-environment), cost-effectiveness (e.g. replacing multiple tests), time-saving compared to conventional testing methods, impact on outcomes for patients and populations (translation into actionable results), availability of wgs typing schemes and reference databases (e.g. for antimicrobial resistance), availability of validated (quality-controlled) wgs workflows (both wet and dry laboratory), availability of expertise to generate, analyze and interpret wgs data, and availability of the appropriate infrastructure (sequence technology, high-performance computing, data storage, etc.). having a high level of expertise, was the strongest predictor for a positive attitude, as was also shown in other surveys [ ] [ ] [ ] . epidemiologists and infection control practitioners should be informed about the benefits and limitations of ngs technologies in order to contribute in identifying tangible field application in public health, allowing the use of wgs output to appropriately guide public health actions [ , ] . another important challenge related to the interpretation of wgs data is the capacity to interpret signals, and thereby separating noise from public health events that require specific actions. consequently, integrating genomics into infection control and surveillance is critically linked to human resource development [ , ] . in the survey, the main reasons stated for not training in the field of genomics were lack of time or access to suitable trainings "…adapted to public health needs". however, the participants of this survey generally expressed a positive attitude towards following (additional) training courses, or workshops in pathogen genomics. educational workshops should be applied to a public health context and bring together the expertise of microbiologists, molecular experts, bioinformaticians, epidemiologists, infection control practitioners, and clinicians. the development of a new discipline called 'genomic epidemiology' integrating information on epidemiological and pathogen sequence characteristics by public health microbiologists, epidemiologists, and risk managers was recommended in the expert opinion on wgs for public health surveillance by the european centre for disease prevention and control (ecdc) in [ ] . ecdc has initiated public health genomics training workshops that bring together experts with epidemiology, microbiology and pathogen genomics backgrounds from european union (eu) member states with interest in implementing the technology in surveillance and outbreak investigations. besides, the zoonotic origin of many clinically relevant pathogens and antimicrobial resistance determinants stresses the importance of a cross-sectoral one health approach. the implementation of wgs should be synchronized and integrated between the human health and veterinary sectors [ ] allowing a better monitoring of the emergence and spread of zoonotic pathogens and antimicrobial resistance-related threats. lack of financial resources was often indicated as a principal reason for not using or planning to use wgs by the respondents of this survey, which was also reported by the european surveys conducted by ecdc [ ] and the european food safety authority (efsa) fig. mind map linking the major and minor themes identified in the qualitative responses, belgium, . codes were identified within the data deductively (i.e. themes that are expected and have been chosen in advance) and inductively (i.e. themes that are derived through analysis). during the thematic analysis the qualitative data from the survey was compared and contrasted with the identified codes. as such, the derived codes were assigned to the relevant text. next, the codes (plain boxes) were merged into categories (colored boxes). the following categories were identified: routine implementation (orange), one-health context (yellow), and feasibility (blue) [ ] . operational costs will be influenced by the processes used in current laboratory practice and differs between viruses and bacteria. whereas drug susceptibility testing and epidemiological typing are commonly performed for bacteria, this is often not the case for viruses detected in the routine laboratory [ ] . therefore, cost-effectiveness of ngs for many bacteria potentially follows from the replacement of conventional characterization methods, whereas for viruses ngs is considered as a tool providing additional complementary information without replacement of the existing methods. further, an important consideration is the added value of ngs for routine diagnostics. as long as ngs is more expensive than the conventional methods and when there is no direct benefit for the individual patient, it will not be used in routine. then the fields of application for surveillance purposes should be clearly defined to be able to justify the additional financial resources needed to perform wgs beside the diagnostic activities. to translate pathogen sequence data into truly useful and actionable information, it needs to be integrated with other types of information (i.e. clinical and epidemiological data). in belgium, most data end-users were concerned about the challenges encountered with the integration of pathogen sequence data with clinical and epidemiological data. indeed, the public health usability of any kind of lab results, including wgs data, is highly dependent on the cross-linkage with contextual epidemiological and clinical information [ , , ] . data integration is often hampered by the incomplete and/or unstandardized nature of the contextual data [ ] . the ongoing digitalization of health data such as laboratory and clinical records may represent an opportunity to review and upgrade traditional data collection processes for communicable disease surveillance. according to world health organization's (who) guidance on managing ethical issues in outbreaks [ ] , rapid data sharing is crucial during an unfolding health emergency. this suggests that pathogen sequence data should be rapidly and openly shared at the start of an outbreak, in many cases before scientific publication. however, many barriers for data sharing remain including authorship/attribution for publications, results dissemination, ethical considerations, data ownership, database access agreements, etc. [ ] . in our survey, practical barriers (lack of data standardization, poor data quality, missing metadata, etc.) seemed to be the major obstacles in belgium for sharing pathogen sequence data and associated metadata for public health purposes. participants mainly mentioned the lack of a central database and clear guidelines. this reflects a lack of information on the effective data sharing through eu-wide genomic surveillance and cross-border outbreak analysis systems managed by ecdc and efsa in support of the member states [ , , ] . finally, % of participants considered the priority to publication as a major bottleneck for sharing pathogen sequence data. publication priority is linked to the importance of guaranteeing reputational returns to research efforts [ , ] . the challenge here is to find a balanced arrangement that allows data sharing in real time and the acknowledgement of research work by giving to researchers who have been involved in data generation the possibility to use and publish their own results in priority. as the use of ngs shifts from research to routine laboratory practices, this data sharing barrier will slowly be alleviated. regarding expertise and availability of personnel, wet and dry lab experts were more concerned about the analysis of pathogen sequence data than the sequencing itself. as was mentioned in a review article of aarestrup et al. and documented in a recent european survey by revez et al., the most important limiting factor in many countries is the lack of access to bioinformatics expertise, especially when used as part of frontline diagnostics [ ] or national public health reference laboratory service [ ] . another point of discussion is the potential impact of ngs on the diagnostic microbiology pathway. traditionally, frontline clinical laboratories perform standard identification, antimicrobial susceptible testing and occasionally typing. isolates may then be referred to reference laboratories based on the need (e.g. diagnostic confirmation) or for surveillance purposes. these reference laboratories perform confirmation testing and advanced characterization. ngs was first implemented at the level of academic or reference laboratories, because of the need for investments, operational costs, and requirements for expertise [ ] while having limited added value for individual patient care. samples must be multiplexed (batching) for cost-effectiveness, which is easier to achieve in large reference laboratories with high volume of sample throughput [ , ] . however, processing delays may be present when samples are shipped to a reference center. these processing delays may result in longer turnaround times rendering this centralized approach inappropriate to support a fast response when needed. the reduced costs of sequencing facilitated the introduction of ngs technology to frontline clinical laboratories. this shift towards a decentralized use may reduce turnaround times, empower hospital-based microbiology, and strengthen local infection control efforts [ ] . this decentralized capacity will allow the inclusion of these data in the surveillance network coordinated by the epidemiologists what will compensate the reduced referral of isolates to reference centers. consequently, the implementation of ngs in routine labs is an important driver to reconsider the future role of nrcs. molecular typing for public health surveillance is undergoing a stepwise transition to ngs [ ] . current and future ngs activities represented in this national survey were mainly in the context of food-and waterborne outbreak detections and investigations, reflecting the priority for these diseases across europe and beyond [ , ] . several criteria should be considered in the process of integrating wgs in a routine laboratory setting [ ] in order to know in which situations and for which pathogens it is worthwhile to use ngs. identifying a set of key drivers that cover all aspects related to the implementation of ngs (utility and feasibility) can help to guide prioritization of pathogens and to efficiently allocate resources. clinical and/or public health significance of the pathogen was scored as the most important driver during the implementation of pathogen genomics in routine public health activities, followed by availability of expertise to generate, analyze and interpret wgs data, and priority of the pathogen with respect to preventing the spread of antimicrobial resistance. qualitative responses revealed the opinion of several participants that the assessment of the added value of new technologies for individual patient care is paramount. if pathogen genomics is routinely used to guide patient management (diagnosis and/or treatment options), the pathogen sequence data gathered for diagnostic purposes can be accumulated for public health activities [ ] . if there is no added value for routine diagnosis, the cost of wgs will have to be covered by limited public health budgets. as a limitation, the relatively low response rate induced a potential volunteer bias as those public health experts being more interested and/or experienced in the field could be more likely to participate in the survey. yet, % of the participants indicated that they were 'not at all' familiar with sequencing technologies and pathogen genomics. further, we noticed a possible underrepresentation of the food, animal and environmental field in comparison to the human field, as well as a low number of bioinformaticians in the survey. in addition, public health professionals from the belgian institute for health (sciensano) might be overrepresented. the majority of microbiologists participating in the survey are based in a nrc, emphasizing surveillance activities and hence less weight to routine diagnostics. given this potential imbalance, it is important to take into account the distribution of profiles within the study population while interpreting the results. however, it is difficult to ascertain the true underlying distribution of the different professional groups within the target population. another limitation of the study is that the specific terminology used in the questions may not have been uniformly understood or consistently interpreted by stakeholders with different professional backgrounds [ ] . public health professionals working in the field of infectious diseases in belgium were in general enthusiastic about public health agencies implementing pathogen genomics for the surveillance and control of infectious diseases. however, introducing genomic methods into public health practice is inevitably linked to the decrease in cost, the introduction in routine activities of frontline clinical labs, the identification of field applications in public health, and the necessary development of new competencies. the results of the survey confirm the need to increase genomic literacy by offering dedicated training opportunities among public health professionals, especially for the data end-users including epidemiologists, clinicians, and infection control practitioners, enabling them to critically assess the utility and feasibility of implementing pathogen genomics in their work activities. as such, those at the forefront (i.e. end-users) may act as "honest brokers" responsible for evaluating the added value of genomic application. in the end, the main driver for the advancement of pathogen genomics in public health practice depends on the added value of this information for the different clinical and public health needs. further, inter-disciplinary (between epidemiologists, microbiologists and bioinformaticians) and intersectoral (one health context) collaboration should be improved in the future to pool expertise and to ensure an integrated and cohesive system for the management of infectious diseases. in terms of feasibility, respondents in this survey were mainly concerned, like their peers in similar european surveys, about data integration, data sharing, and the cost of sequencing technologies. overall, this survey helps to better understand the perceived utility and feasibility of pathogen genomics according to public health professionals and can inform further guidance to facilitate its implementation in belgium. future challenges can be anticipated by performing a similar survey among public health experts based in a country that already progressed further in the process of implementing pathogen genomics within their public health surveillance system. supplementary information accompanies this paper at https://doi.org/ . /s - - - . additional file . "questionnaire". description of data: "list of questions included in the online survey". additional file . "selection of target groups for the survey". description of data: "an overview of existing surveillance systems to identify all public health professionals who (would potentially) generate or use ngs data for the surveillance of infectious diseases based in different institutes and organizations in belgium." additional file . 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human, animal, food, feed and food/feed environmental samples in the joint ecdc-efsa molecular typing database data sharing in genomics -re-shaping scientific practice impact of food and water-borne diseases on european population health world health organization. who estimates of the global burden of foodborne diseases real-time analysis and visualization of pathogen sequence data publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we would like to thank all study participants who took the time to complete the survey and provided valuable insights to reach to objectives of our study. these include the scientists from the belgian institute for health (sciensano) and the federal agency for the safety of the food chain (fasfc) working in infectious disease departments; physicians and infection control practitioners of the regional infectious disease control teams from the three regions in belgium; microbiologists from national reference centers (nrcs) and from sentinel laboratories; members from the belgian society of infection specialists and clinical microbiologists (bvikm), the belgian antibiotic policy coordination committee (bapcoc), the belgian infection control society (bics), and the belgian society for food microbiology (bsfm); clinicians, clinical biologists and hospital hygienists participating in sentinel surveillance networks; and public health experts within the ministry of health. we also would like to thank jérome ambroise, jimmy van den eynden, and boudewijn catry for pre-testing the survey, and vera cantaert, yves dupont, chloé wyndham-thomas, and karl mertens for their contributions in recruiting participants. this research was supported by the .be ready project financed by sciensano. the raw data analyzed during the current study are available from the corresponding author on reasonable request. the first page of the questionnaire explained the purpose of the research, the measures taken to protect respondents' confidentiality and the voluntary nature of participation. questionnaire respondents were asked to tick 'agree' at the start of the questionnaire to indicate that they consented to take part in the study and were willing to complete an anonymized questionnaire. ethics approval was deemed unnecessary according to national regulations (law of april ; http://www.ejustice.just.fgov.be/mopdf/ / / _ . pdf#page ), as participation was anonymous and no medical data were processed. not applicable. the authors declare that they have no competing interests. key: cord- - bu zo authors: tang, daxing; tou, jinfa; wang, jinhu; chen, qingjiang; wang, wei; huang, jinjin; zhao, hangyan; wei, jia; xu, zheming; zhao, dongyan; fu, junfen; shu, qiang title: prevention and control strategies for emergency, limited-term, and elective operations in pediatric surgery during the epidemic period of covid- date: - - journal: nan doi: . /wjps- - sha: doc_id: cord_uid: bu zo the outbreak of coronavirus disease (covid- ) caused by severe acute respiratory syndrome coronavirus (sars-cov- ) has spread to more than countries. children approved to be susceptible to sars-cov- infection. preventing and controlling the epidemic while ensuring orderly flows of pediatric surgery clinical work has proven to be a big challenge for both patients and clinicians during the epidemic. based on the transmission characteristics of sars-cov- and the requirements for prevention and control of covid- , the authors proposed some concrete measures and practical strategies of managing emergency, limited-term, and elective pediatric surgeries during the epidemic period. the outbreak of coronavirus disease (covid- ) caused by severe acute respiratory syndrome coronavirus (sars-cov- ) has spread to more than countries. children approved to be susceptible to sars-cov- infection. preventing and controlling the epidemic while ensuring orderly flows of pediatric surgery clinical work has proven to be a big challenge for both patients and clinicians during the epidemic. based on the transmission characteristics of sars-cov- and the requirements for prevention and control of covid- , the authors proposed some concrete measures and practical strategies of managing emergency, limited-term, and elective pediatric surgeries during the epidemic period. the epidemic of a novel coronavirus infectionhas spread to more than countries. on january , , the world health organization (who) announced that the outbreak of the new coronavirus constitutes a "public health emergency of international concern (pheic)". on february , , the international virus classification commission named this virus severe acute respiratory syndrome coronavirus (sars-cov- ). on the same day, who named the disease caused by sars-cov- infection as coronavirus disease . on january , , the national health commission of china categorized covid- as a class b infectious disease but administered it as a class a infectious disease. many countries and regions were involved in this epidemic and the number of infected cases continues to increase. some countries and regions implemented very stringent prevention and control measures. preventing and controlling the epidemic while ensuring the orderly flows of pediatric surgery clinical work has proven to be a big challenge for both patients and clinicians during the epidemic period. several publications that introduced the prevention strategies for surgical operations during the covid- epidemic have been launched. [ ] [ ] [ ] because children are susceptible to sars-cov- , - several diagnostic guidelines or consensuses for children were published. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] however, thus far, no publications providing systemic suggestions or strategies for prevention of covid- in the field of pediatric surgery have been identified. based on the "technical guidelines for the prevention and control of new coronavirus infection in medical institutions (first edition)," "diagnosis and treatment plan on the new coronavirus inflicted pneumonia (sixth trial edition, revised)" (both released by the national health commission of china), "recommendations for the prevention and control of general surgery in the background of new coronavirus outbreak," and other relevant latest reports, we propose the following control measures and practical strategies for pediatric surgery practice during the covid- epidemic. clinical characteristics of covid- in children epidemiological characteristics patients with covid- infection are the primary sources of infection, but the incubation period patients and patients with asymptomatic infection are also sources of infection. the transmission is mainly through the respiratory tract, by droplets when patients cough, speak loudly, or sneeze. the virus can also be transmitted through close contact (such as touching the mouth or nose, or conjunctiva by contaminated hands). aerosol and fecal-oral transmission remain to be confirmed. in addition, it is currently uncertain whether the virus can be transmitted through mother-to-child vertical transmission open access or through breast milk. the population is generally susceptible. the elderly and those with basic diseases are prone to severe symptoms and complications when infected. infants and young children are likely to have mild symptoms when infected. clinical manifestations and subgroups the incubation period is - days, and most commonly - days. fever and coughing are often observed, as well as fatigue, myalgia, stuffy nose, runny nose, sneezing, sore throat, headache, dizziness, nausea, vomiting, abdominal pain and diarrhea. blood routine leukocyte counts and absolute lymphocyte counts are mostly normal. the lung image is characterized by ground glass shadow on the outside of the lung. mild manifestations mainly show acute upper respiratory infections, including fever, fatigue, myalgia, cough, sore throat, runny nose, and sneezing. while physical examination reveals congestion in the pharynx, no positive signs exist in the lungs. some children may have no fever or may have only digestive symptoms such as nausea, vomiting, abdominal pain, and diarrhea; the common cases show symptoms of pneumonia, frequent fever, and cough, and mostly dry cough followed by sputum cough. some may have wheezing, but no obvious hypoxia such as shortness of breath. lungs can hear sputum or dry snoring and/or wet snoring. some children did not have any clinical symptoms and signs, but chest ct showed lung lesions, which were diagnosed subclinical. most cases with children are mild or subclinical; severe cases show early respiratory symptoms such as fever and cough and can be accompanied by gastrointestinal symptoms such as diarrhea. this usually progresses around one week. patients have difficulty breathing, have central cyanosis, or do not take oxygen hypoxic manifestations such as inferior pulse blood oxygen saturation < . ; critically ill cases can progress rapidly to acute respiratory distress syndrome (ards) or to respiratory failure and also may develop shock, encephalopathy, myocardial injury or heart failure, coagulopathy, acute kidney injury, and other multiple organ dysfunctions, which can be life threatening. criteria for the diagnosis of suspected and confirmed cases in children [ ] suspected cases: with any one of the following epidemiological histories and any two of the clinical manifestations, diagnosis can be made. epidemiological history: ( ) traveling or living in areas with continuous local transmission cases within two weeks before the onset; ( ) contact with patients in fever or with respiratory symptoms from areas with continuous local transmission cases within two weeks before the onset; ( ) have a history of close contact with confirmed or suspected cases of covid- within two weeks before the onset of disease; ( ) have clustering onset: in addition to this child, there are other patients with fever or respiratory symptoms, including suspected or confirmed covid- cases; ( ) babies given birth by pregnant women with suspected or confirmed neonatal covid- . clinical manifestations: ( ) fever, fatigue, dry cough, some children may have no fever or low fever; ( ) above-mentioned imaging manifestations; ( ) white blood cell count is normal or decreased in the early stage of onset, or the lymphocyte count is reduced. confirmed cases: suspected cases can be diagnosed if they meet any of the following pathogenic test results: ( ) real-time fluorescence pcr detection of sars-cov- nucleic acid samples in throat swabs, sputum, stool, or blood; ( ) above-mentioned sequencing and known virus genes sars-cov- are highly homologous; the above specimens were isolated and cultured to sars-cov- particles. basic classification of pediatric surgery and principles of admission during the covid- epidemic emergency surgery is a surgery that should be performed immediately after examination and evaluation of lifethreatening diseases, such as severe trauma, acute abdominal disease, and testicular torsion. even if a child has been diagnosed or suspected with covid- , the surgery should be performed in the designated hospital under the effective protection (see below). if pediatric surgeons are not available in the designated hospital, pediatric surgeons from other hospitals can conduct the operation after obtaining permission in the designated hospital. limited-term surgery, a surgery which should be conducted in a limited time, is carried out to treat severe or rapidly progressive diseases, including advanced cancers, biliary atresia, and giant hydronephrosis with developing kidney function continues declining. if a patient is diagnosed, or suspected with covid- , the operation can be postponed appropriately. the operation should be scheduled once the two results of nucleic acid tests are negative after two weeks or once the covid- expert group has confirmed the exclusion or recovery. however, it is still recommended to perform the operation under essential protection (see below). if the suspected case is ruled out or if the local epidemic situation has been effectively controlled, it is recommended that these patients receive operations in batches under certain protection. meanwhile, a prearranged planning should be prepared in the event that patients which received operations develop clinical symptoms and signs of covid- postoperatively. once these patients are confirmed or highly suspected by radiological examination and nucleic acid test, person in close contact with the patients should be effectively traced and isolated, and operation rooms should be disinfected. in that way, the risk of covid- transmission can be highly minimized. elective surgery is performed for diseases that can be arranged after months or even longer without serious outcomes, such as incarcerated inguinal hernia or hypospadias. to avoid the risk of covid- transmission, it is recommended that these surgeries should be postponed until the outbreak is under control. open access outpatient management of pediatric surgery [ , ] according to the epidemic characteristics of covid- and the experience accumulated in clinical practice, some patients can be infected but not present with symptoms. a few parents may conceal the history of coming from an affected area or of contact with patients with covid- ; therefore, the protective work of covid- is still significant. outpatient personnel protection: outpatient personnel including patients and their dependents, clinical staff, cleaners and persons may in the outpatient hall. pretreatment education should be strengthened by the official website, wechat public account, outpatient hall and other channels; moreover, one dependent accompany policy is carried out these days. patients with respiratory symptoms, fever, or the history of close contact with patients with covid- within days should be referred to the covid- specialist clinic. patients and dependents are advised to wear masks and observe the clinic order. clinical staff and cleaners should carry out the following protective measures such as wearing work apparel, surgical masks or n masks, disposable round caps, and gloves. outpatient equipment and environmental disinfection: there are few invasive examination equipment in a surgical outpatient clinic. however, the attention should be paid to the disinfection of the surface of relevant instruments and equipment, including tables and chairs, examination beds and other items. it is recommended to use sodium hypochlorite disinfectant to wipe the tables, chairs, and surface of the things used before and after the outpatient treatment. the purification of the air in the outpatient clinic is mainly based on ventilation. however, the natural ventilation of clinic is somewhere unavailable. thus, mechanical ventilations are recommended in the units where conditions permit. attention should be paid to the regular cleaning of ventilation equipment. after daily clinic work, ultraviolet irradiation or ultralow volume spraying should be used to thoroughly disinfect the clinic places. distinguishing patients with covid- before admission (including dependents): during the covid- epidemic, expect the routine pediatric surgical information, we should also inquire about the patient's epidemiological history in detail, especially the contacting history of patients and dependents children with people from covid- epidemic area and whether there are suspected or confirmed cases in their community, and so on. we should pay more attention to children with history of contact. meanwhile, the presence of fever, dry cough, and dyspnea are observed. blood test and chest imaging examination are listed as routine examinations. any abnormality, the expert group of covid- diagnosis, and treatment should be consulted immediately. no missing case of covid- diagnosis is recommended as far as possible. actually, some pediatric surgical diseases have similar clinical manifestations, especially the infectious diseases, outpatient physicians should check carefully. if patient performs suspicious manifestations, they should be transferred to a fever clinic in accordance with the protection principle. once the suspected or confirmed diagnosis is made, the patient should be quarantined, treated, and reported immediately according to regulations. in-patient area protection [ , , ] admission of the emergency patients with confirmed or suspected infection of covid- the technical guidelines for the prevention and control of covid- infections in medical institutions (first edition) must be conducted strictly. so far, the isolation wards have already been set up in the designated hospitals according to the national standards requirements which including the building layout, routine procedures, and contacts, droplet, airborne isolation precautions, and so on. critically ill children should be admitted in the isolated intensive care unit (icu) or in the isolated wards equipped with monitoring and rescue facilities. mixed treatment with other sick children suffered from non-covid- is not allowed. medical staffs should strictly obey the principles of personal protective equipment use. the children diagnosed or suspected with covid- should be placed in the specific isolated wards, no matter what surgical specialties disease they have. perioperative management should be completed jointly with various specialized surgeons and with physicians and nurses from the isolated wards. in this situation, it is recommended to choose shorter duration as a priority in the surgical approach to minimize contact with the patient and to reduce the risk of cross infection. for instance, if the surgeon considered that the duration of open surgery is shorter than that of laparoscopic surgery according to his own experience, open surgery should be chosen accordingly. in addition, open surgery requires simpler surgical instruments, shorter preparation time, and easier postoperative sterilization as compared with these for laparoscopic surgery. admission of the patients preliminary excluded the possibility of covid- infection an examination of the national and provincial health commission official websites shows that there are no guideline documents or recommendations for the patients receiving limited-term surgery with initially exclude of covid- infection or precautions to prevent transmission of infectious agents. thus, the proposal of the article mainly refers to "guideline for infection control for h n influenza in health care." ward protection: ( ) partition isolation: to avoid cross infection of hospitalizing children or their accompanying parents in covid- incubation period or with asymptomatic infection within wards, it is recommended that all the rooms in the ward should be set as a single bed during the epidemic period. if the conditions are limited, > m spatial separation between beds is advised in shared rooms according to the precaution management. ( ) proper air and floor disinfection: natural ventilation by opening windows twice a day, at least one hour each time in the rooms where patients were placed; ultraviolet disinfection once or twice a day, at least min each time in empty room. doors and windows are closed during the disinfection and after disinfection, and windows are opened for ventilation. for windowless rooms or storage rooms, regular mechanical exhaust and ultraviolet disinfection are required. the ventilation should be ensured in recovery room for hours by exhaust equipment. the frequency of ultraviolet disinfection changes from once a day to twice a day for dressing rooms, treatment rooms and recovery rooms. disinfectant with effective chlorine in concentration of mg/l can be wiped or sprayed twice a day on the floor and in the corridors of the ward. wet cleaning shall be kept during ground wiping, and disinfection shall be carried out promptly in case of pollution. ( ) proper cleaning and disinfection of surfaces in patient-care areas: the surfaces frequently touched by children and their parents in the ward (such as bedrails, headboard, bedside tables, pagers, monitors, doorknobs, and so on) should be disinfected with effective chlorine containing disinfectant using a concentration of mg/l for min every day and then wiped by clean water. corrosion-susceptible items are sterilized by wiping with % ethanol twice. thermometers, stethoscopes, sphygmomanometers, and other medical equipment (such as goggles without obvious pollution) should be disinfected with % ethanol twice after use. ( ) medical staff precautions: medical staffs are at risk of cross infection as they need to face many people, including the patients, their parents, and other medical staff. all departments of a healthcare should educate and train healthcare personnel on the principles and recommended practices of covid- standard precautions. reasonable shift arrangement and shift system implementation are also required. medical staffs should self-monitor whether they have fever, dry cough, fatigue, and other symptoms and should report their status to the relevant departments of healthcare daily. if any associated symptoms are present, essential monitor and isolation procedures should be performed as soon as possible. healthcare personnel should wear appropriate personal protective equipment, such as surgical mask, goggles, face shield, disposable caps, gloves, before carry out routine medical work. precautions should be strictly observed according to "the technical guidelines for the prevention and control of the new coronary virus infections in medical institutions (first edition)" when healthcare workers perform the procedures such as change dressing, remove drainage or change ostomy bag and expose to patients' blood, body fluids or excretions. proper hand washing is effective precaution in preventing transmission of viruses. healthcare personnel should abide by the principles of hand hygiene before and after having direct contact with patients and after removing gloves. ( ) precautions for non-healthcare professionals. gatherings of many non-healthcare professionals increase the transmission risk of infectious agents in surgical wards. thus, it is crucial to strengthen the precautions for patients, their parents, accompanying persons, and the cleaning staff. health education for hospitalized children and their parents should be strengthened in each department, and patients' parents need to sign the "commitment for the special epidemic notification" before admission. only one parent was recommended to accompany the children, and any visitor should be refused. patients and accompanying family members should reduce their activity space to lessen the transmission risk. wearing a mask is necessary in the ward public area. when coughing or sneezing, one's month and nose need to be covered with a tissue or with one's elbow. washing hands and disinfection is required after contact with respiratory secretions, before meals, and after toileting. keep the room ventilated. the temperature of the patients, their parents, and the cleaning staff need to be measured twice a day, and any associated symptom should be reported to the special medical professional, such as fever, cough, or fatigue. perioperative protection [ ] protection for confirmed or suspected children who need emergency surgery preoperative preparation: wearing warning signs and surgical masks is required for patients and their accompanying parents consistent with hospital uniform management rules; medical records should be marked with warning labels. a negative pressure transfer vehicle should be used to deliver the patients with responsible physician wearing protection gear to the special isolation zone, which is set up by operating room, through the special passageway and elevator to avoid contamination of the operating room. ( ) operating room preparations: the operation should be carried out by less participants in the designated negative pressure or special operating room designed for infection with conspicuous signs posting at the door. and the entry and exit for noninvolvement personnel should be declined. the operating room is equipped with a thermometer to monitor the body temperature of each before the beginning of operation. the negative pressure should be kept at − pa. if negative pressure operating room is not available, the surgery should be performed in the operating room which is nearest to the special channel and the most marginal area with turning off the laminar flow. ( ) participant preparations: training for pre-employment and the use of personal protection gear is required for participants, including surgeons, anesthesiologists, and nurses, who are in charge of filling surgical participation registration form and record work. according to the three-level protection rules, health workers and anesthesiologists are required to wear a double-layer disposable cap, medical mask, disposable isolation operating coat and medical protective suits, goggles, or masks, double-layer sterile gloves, and over-the-knee gloves. it is open access recommended to wear protective suits under supervision of special personnel according to the "health workers wear protection gear procedures." ( ) surgical and anesthetic equipment preparation: before operation, full communication should be carried out and items should be prepared enough to avoid the flow of personnel and articles as much as possible, which affects the operating room negative pressure efficiency. disposable diagnosis and treatment supplies, medical appliances and nursing supplies are preferred. surgical and anesthetic instruments and equipment should be prepared as required as specialty by surgery. it is crucial to use all medical supplies according to the principle of dedicated personnel. intraoperative management: ( ) anesthetic management and protection: the situation of children and the operation requirements need to be considered when choosing the appropriate anesthetic method. it is recommended to choose anesthetic methods and medicine with minimal impact on child on the basis of ensuring safety and painlessness of children, as well as safety of medical workers meanwhile. for pediatric patients that cry more often and do not cooperate, appropriate sedation can be applied before surgery to reduce the risk of transmission of saliva and droplet. the three-level protection measures are required for anesthesiologists, and one more layer of gloves is necessary before intubation during the endotracheal intubation for general anesthesia, then be removed after the completion of intubation. medication should be used on those who have venous access as soon as possible to get sedation after entering the room, and sevoflurane inhalation can be applied on those without venous access to get sedation, followed by the establishment of venous access. before anesthesia induction, double layer of warm and moist gauzes should be used to cover the mouth and nose of patient, followed by mask sustained high flow preoxygenation. it is recommended that to choose rapid anesthesia induction, moderate sedation and sufficient muscle relaxant are necessary to avoid choking cough, and intubation should be performed by skilled pediatric anesthesiologists under optimal conditions for high success rate. in case of difficult airway, the laryngeal mask should be placed after the failure of the first endotracheal intubation (attempt) to avoid the risk of infection caused by repeated attempts of endotracheal intubation. to avoid being close to operating area, the use of visual laryngoscope will be required. the patients with oral secretions could be cleaned with a closed suction system after completion of endotracheal intubation to avoid secretion contamination, if there is no obstruction of respiratory tract. monitoring should be strengthened during operation, and severe patients are required to be closely monitored and dealt with in time due to the possible existence of acute lung injury, ards, heart failure, acid-base imbalance, and electrolyte disorders. at the end of the operation, the endotracheal tube should be removed under deep sedation with strengthening monitoring. it is recommended that complete the sputum suction work before the child wake up and appropriate injection of lidocaine before extubation. the mouth and nose of patient should be covered with two warm and moist gauzes to reduce the secretion spatter caused by choking cough as much as possible. antagonists are not recommended. the filter at the end of the tracheal catheter is required to be kept during extubation. the work of postoperative analgesia is necessary to reduce crying and restlessness of children after extubation. the patient needs to be transferred to the isolation ward directly for continued treatment when steward recovery scores are ≥ points after extubation with an observation in the operation. those severe patients need to be transferred to isolation icu directly with keeping trachea catheter. it is recommended to deepen the anesthesia or add appropriate dosage of muscle relaxant before transferring. ( ) intraoperative precautions: general open operations refer to the "health workers wear protection gear procedures." the contamination, caused by mixture of gas when cutting tissues, should be avoided during laparoscopic surgery in operating room. in addition to the precautions of patients' blood, secretions, and excrements during the operation, special attention should be paid to the aerosol produced when using electrosurgical equipment such as electric knife. the electric knife should be used matching with the minimum effective power and the smoke absorbing device. doctors and nurses should operate accurately and normatively to avoid injuries caused by knife, suture needle, and other instruments. participants are asked to remove the protective equipment according to the "health workers wear protection gear procedures" after the operation, and leave through the special passageway. postoperative protection: ( ) transshipment management: patients should be transferred postoperatively to the designated isolation ward for treatment through the prescribed route after report to the hospital infection management department and medical affairs department. according to the double-medical team leader system, the patient who was transferred to the isolation ward should be managed by leaders from isolation ward and surgical team. precautions should be strictly observed during transshipment. transfer flatbed covered with disposable sheets is required to be thoroughly disinfected by disinfectant with effective chlorine in concentration of mg/l after transfer. ( ) operating room management: the operation room is fumigated and disinfected with peroxyacetic acid after turning off the operation laminar flow and air supply. the high efficiency filter of the operation is required to be replaced in time by notifying laminar flow engineers and technicians. contaminants should be removed from floor, wall, and articles in the operating room, which should be sprayed and wiped by disinfectant with effective chlorine in concentration of mg/l, at least min each time. then, the floor should be mopped by clean water. the surface and air sampling test in operation should be carried out after disinfection by contacting the infection management department, and operation can be used again after the open access results are qualified. turn on laminar flow and ventilation for at least hours. ( ) management of objects and specimens during operation: after operation, the reusable devices and cloths need to be sprayed with moisturizer, sealed, and packed with double-layer of yellow plastic bag, affixed with the "sars-cov " logo and the name of the article, and placed separately. the supply center staffs are called to collect them in time for the subsequent disinfection. disposable articles, medical protection equipment, and body fluid, flushing fluid generated by suspected or confirmed patients with sars-cov infection should be placed and sealed in double-layer of yellow medical waste bags, affixing with the "sars-cov " logo outside. then, those bags should be placed separately and processed as infectious medical waste. the specimen bag, labeling with "sars-cov ," was sent to the pathology department for diagnosis. ( ) medical record of operation: in addition to the information of patients, the "infectious diseases registration form" should be filled by surgeon in time, as well as updating of the diagnosis of suspected cases and the surgical recovery status of patients. ( ) follow-up management: patients are transferred to the designated negative pressure isolation ward. precautions should be strictly observed according to "technical guidelines for the prevention and control of new coronavirus infections in medical institutions (first edition)" when medical workers entering the isolation ward for rounds, dress changing, and nursing. ( ) discharge criteria: different from the usual surgical discharge criteria, the consultation of hospital covid- expert group needs to be considered that whether can be discharged or need continuous home isolation with disease control and monitoring for those patients who still need further isolation after surgery according to the regulations. protection for the patients who need limited-time surgery and preliminary excluded possibility of suspected or confirmed with covid- infection during the covid- epidemic period, a higher level of protection is needed to avoid large-scale infections among medical staff due to missed cases. in addition to the routine operations as usual, additional protective standards are required during the perioperative period, including: ( ) isolation of all patients' blood, body fluids, secretions, and excreta is necessary because of their infectivity. precautions must be performed when exposed to the above-mentioned substances or to nonintact skin and mucous membranes. ( ) emphasis on two-way precaution. it is necessary to prevent the transmission of disease from patients to medical staff and also to prevent the reverse transmission from medical staff to patients. specific measures of standard protection include: ( ) hands cleaning and disinfection, which should meet the requirements of the "hand hygiene specification for health personnel," is an important measure to prevent contact transmission. ( ) wearing gloves is required when exposed to blood, body fluids, secretions, excreta, and other substances, as well as articles contaminated by them. ( ) wash hands immediately after removing the gloves. ( ) wearing surgical masks, protective glasses or masks, and isolation gown or waterproof aprons is necessary to protect work clothes, face, and eyes of medical workers from contaminating by spatter of blood, body fluids, secretions, and so on. ( ) special attention should be paid to all sharpeners to prevent stab wounds. ( ) correct disinfection and sterilization measures should be taken for the medical devices and appliances after use. ( ) during the epidemic, it is recommended to wear medical protective masks, as well as protective glasses or masks, gloves, isolation gown, protective suits, shoe gloves, and so on, especially when performing endotracheal intubation for general anesthesia. protection gear should be used correctly in accordance with the requirements of the "technical specification for the isolation of medical institutions." management of patient who had postoperatively clinical symptoms and suspected or confirmed of covid- infection: ( ) the above patients, who have even nucleic acid tested negative for the virus once, should be reported to the relevant departments of hospital immediately. ( ) the patients should be transferred to the isolation ward as soon as possible. ( ) the related ward, operating room, and surgical instruments need to be disinfected as required, and treatment of other patients is not allowed in the above-mentioned area. ( ) all medical workers and non-medical workers in the ward with a history of contact should be retrospectively and quarantined for strict observation for days. the condition of child with pediatric surgical diseases changes rapidly. patients will be asked for further consultation within - weeks after the surgery. however, during the epidemic, convenient contact medias, such as wechat, the official website, and department phone numbers, can be provided for parents to consult for the recovery status of the patients. outpatient consultation can be postponed until the epidemic is under control, and traffic isolation is completely removed if no urgent treatment is needed. general elective surgery, day surgery, and outpatient clinic surgery these operations need to be delayed until the notification from the superior department of government; however, online or remote appointments can be registered in various ways to carry out preoperative health education. when an emergency occurs, such as hernia incarceration, patients should go to the hospital immediately. after receiving the notification from the superior department, it is recommended to make appointments at different times and to perform the operations gradually to avoid crowd gathering in a short time in the hospital. under the current epidemic situation, patients of pediatric surgery need special protection. for patients with open access confirmed or suspected sars-cov infection, limitedterm surgery should be postponed. if emergency surgery is necessary, protection should be carried out strictly following the strategies described in this article. elective surgery will be resumed after the epidemic situation is gradually under controlled. contributors dt, jt, jw, cq and ww proposed the work and wrote the strategy formulation of the article. jh, hz, jw, zx, dz and jf wrote the rest of the article. qs is the guarantor of the article. funding this article was supported by zhejiang university special scientific research fund for covid- prevention and control. competing interests none declared. patient consent for publication not required. ethics approval not required for this review article. provenance and peer review not commissioned; externally peer reviewed. data availability statement data sharing not applicable as no datasets generated and/or analyzed for this study. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. orcid id zheming xu http:// orcid. org/ - - - references severe acute respiratory syndrome-related coronavirus: the species and its viruses-a statement of the coronavirus study group national administration of traditional chinese medicine. pneumonia diagnosis and treatment plan for new coronavirus infection (trial version revision) (in chinese announcement of national health commission of the people's republic of china perioperative prevention and control strategies for surgical patients in the context of new coronavirus pneumonia (in chinese) consensus on emergency surgery and infection prevention and control for severe trauma patients with novel coronavirus pneumonia first case of novel coronavirus infection in children in shanghai (in chinese) novel coronavirus infection in children with cases (in chinese) the society of pediatrics, chinese medical association. the editorial board, chinese journal of pediatrics. recommendations for the diagnosis, prevention and control of the novel coronavirus infection in children (first interim edition) questions and answers for prevention of severe acute respiratory syndrome coronavirus infection in children (in chinese) novel coronavirus infection: pediatric professionals' perspectives and action facing the pandemic of novel coronavirus infections: the pediatric perspectives diagnosis, treatment and prevention of novel coronavirus infection in children: experts' consensus statement advices on the prevention and control of nosocomial infection of novel coronavirus within children's hospitals diagnosis, treatment, and prevention of novel coronavirus infection in children: experts' consensus statement announcement on the issuance of technical guidelines for the prevention and control of the new coronary virus infections in medical institutions new coronavirus: new challenges for pediatricians national health commission of the people's republic of china. the new coronary virus transmission pathways and the guideline for prevention national health commission of the people's republic of china, national administration of the people's republic of china. pneumonia diagnosis and treatment plan for new coronavirus infection (trial version revision) (in chinese national health commission of the people's republic of china national health commission of the people's republic of china. regulation for prevention and control of healthcare associated infection of airborne transmission disease in healthcare facilities guideline for infection control for h n influenza in health care national health commission of the people's republic of china. standard for hand hygiene for healthcare workers in healthcare settings national health commission of the people's republic of china. technique standard for isolation in hospital key: cord- - gsnmegj authors: eccleston-turner, mark; mcardle, scarlett title: the law of responsibility and the world health organisation: a case study on the west african ebola outbreak date: - - journal: infectious diseases in the new millennium doi: . / - - - - _ sha: doc_id: cord_uid: gsnmegj the delay between the who being made aware of the ebola epidemic in west africa and declaring it a public health emergency of international concern (pheic) has been the subject of some considerable criticism in the literature, as well as in the report of the ebola interim assessment panel commissioned by the who, which stated that that ‘significant and unjustifiable delays occurred in the declaration of a public health emergency of international concern (pheic) by who.’ this paper examines this late declaration of a pheic for ebola through the lens of the law of responsibility, arguing that the who incurs responsibility for this delay. the law of responsibility is long standing in international law as the framework for providing redress for breaches of law. it gives rise to an obligation to provide redress and ensures some form of culpability for a breach of international law. in this paper we argue that the who does not merely have the power to declare a pheic via the international health regulations ( ), but also has a legal obligation to do so when the criteria are met. an obligation which we argue, they breached in failing to declare the recent ebola outbreak in west africa a pheic in a timely manner. this breach should then engage the law of responsibility for the consequences of the delay. the paper argues, however, that there exist substantial issues with the application of the principles of responsibility to international organizations. the law of responsibility establishes consequences and redress for breaches of international law; it is a longstanding element of public international law. at its most basic, responsibility in international law ensures some form of culpability for an international wrongful act and gives rise to an obligation for the wrongdoer to provide redress. the key principles in the law of responsibility establish that responsibility will arise when an internationally wrongful act has been committed, which constitutes a breach of international law, and which is attributable to the international actor concerned. in this chapter we apply the principles of the law of responsibility to the west african ebola epidemic, arguing that legal responsibility can be established at an international level on the part of the world health organisation (who) for their delayed action in respect of the west african ebola response. the west african ebola epidemic began in guinea during december , and the who was officially notified of the outbreak on the rd of march, . the who did not declare the outbreak to be a 'public health emergency of international concern' (pheic) until august th that year. by this time there were confirmed and suspected cases of ebola, nearly a thousand of which were confirmed or suspected to have resulted in death. this delay between the who being made aware of the epidemic and declaring it a pheic has been the subject of considerable criticism in the literature. further criticism came via the report of the ebola interim assessment panel commissioned by the who, which stated that 'significant and unjustifiable delays occurred in the declaration of a pheic by the who.' the international health regulations (ihrs) empower the director-general of the who to declare an event a pheic. the ihrs were passed by the world health assembly in , as an update to the regulations, and serve as the primary set of rules that govern state conduct in the build up to and during infectious disease outbreaks. the overarching goal of the regulations is to prevent, detect and respond to the international spread of infectious diseases and other public health emergencies, whilst at the same time attempting to prevent unnecessary restrictions being placed upon trade and travel to affected states. the regulations define a pheic as an extraordinary event which is determined: (i) to constitute a public health risk to other states through the international spread of disease and (ii) to potentially require a coordinated international response. the ability to declare an event a public health emergency of international concern provides the who with significant power and influence over international health affairs. first, such a declaration directs international attention and resources to the public health emergency ; this is intended to ensure a fast, coordinated global response to the outbreak. there is, however, a second, negative, element to this influence with the potentia significant impact on travel and trade that a pheic can give rise to. as adam rainis houston identifies in his chapter, the concept of a declaring a disease as a pheic on the basis of characteristics did not properly exist before the revisions to the international health regulations; rather, only specific diseases (cholera, plague and yellow fever, and smallpox) were considered notifiable under the ihr. since the who's mechanisms for determining if an event constituted a pheic have been tested on a number of occasions, resulting in a declaration in for h n pandemic influenza, in for polio, in for ebola, and in for zika, for ebola in the drc and for covid- . other events-mers in and yellow fever in -have been considered potential pheics, but have not resulted in declarations. the seemingly inconsistent approach the who takes to declaring, or not declaring, an event a pheic has resulted in some considerable criticism of the organisation and its decision-making processes in this area. while the focus of this chapter is on the west african ebola outbreak, as this is arguably the most controversial use of the who's pheic powers in the new millennium, it is important to note that our arguments in respect of ebola are generalisable to other pheics. we return to this later in the chapter. in the meantime, we present four claims: first, that the who is a distinct legal actor on the international stage capable of incurring responsibility for its actions; second, that the who does not merely have the power to declare a pheic, but also see 'foreword' and article world health organisation, 'international health regulations' ( ) . article , ibid. article , ibid. lawrence gostin & eric friedman, (n ) . a pheic being declared empowers the who to make a number of recommendations regarding the movement of persons, baggage, cargo, containers, conveyances, goods and/or postal parcels to states involved in, or at risk from, the outbreak. these recommendations to states can include the closing of borders between states; requiring vaccinations within the state or to gain entry; implement quarantine for those suspected of being affected; isolation for those affected; and implement entry or exit screening on persons from affected regions, and are designed to minimise or control the public health threat. see: reinalda and verbeek ( ) . p. [-] . andrus et al. ( ) , gostin and lucey ( ) and lucey and gostin ( ) . has a legal obligation to do so and to do so in a timely manner; third, that the who failed to discharge this legal obligation in failing to declare the recent ebola outbreak in west africa a pheic in a timely manner; and fourth, that the failure to declare a pheic in a timely manner gives rise to legal responsibility at the international level for the consequences of the delay. as we have noted elsewhere, the who is substantially lacking in appropriate accountability mechanisms, particularly in respect of the actions of the organisation during a pheic. we have also suggested appropriate mechanisms by which the who could improve its accountability mechanisms. accountability and responsibility are inextricably linked: while reform of the accountability system would be of great benefit to the who and the international system as a whole, this should be done in combination with development of the international law of responsibility to enable greater redress for wrongful acts when they occur. the law of responsibility enables legal action to be brought against a responsible actor at the international level. as hafner stated, "accountability seems to reflect primarily the need to attribute certain activities under international law to such actors as a precondition for imposing on them responsibility under international law." responsibility in international law originally developed in the context of the traditional nature of international law being focused around bilateral state relations and the importance of state sovereignty. if an international legal obligation had been breached then this offended the wronged state's sovereign rights and, consequently, such state should have the ability to reinforce and uphold its rights. consequently, the law of responsibility was the law of state responsibility. in spite of this early limitation, the ability to apply this law beyond the state was soon being called for. these calls largely arose in response to the growth of international organisations, belgian nationals new york, february , no. ( kent ( ) ; the secretary'general, investigation by the office of internal oversight both in terms of number and powers. this eventually led in to the international law commission (ilc) developing the articles on the responsibility of international organisations (ario). in spite of the established differences in nature and powers of states and international organisations, the ario largely mirror the ilc's earlier articles on state responsibility, which are well established within international law. while the principles may largely still be in their infancy in respect of international organisations, there exists a breadth of state-based practice to assist in the interpretation and application of such principles. in order for the actions of the who to be addressed by the ario, and in order for the who's delay in declaring a pheic to be addressed by the law of responsibility, two factors must be established. first, the who must be accepted as a distinct legal actor at the international level. second, the ability to declare a pheic in a timely fashion must be considered to not just be a power of the who, but a legal obligation as well. we argue below that these two factors can be established. from this it will be clear that there exists an international obligation on the part of an autonomous international actor, which was not upheld in this situation. a capacity for responsibility? the first thing that must be considered is the nature of the who as an autonomous subject of international law, as only subjects of international law are capable of possessing the sort of legal personality required in order to be subject to the law of responsibility. the broad concept of autonomy is a complex one. in existing in this distinct manner, it is only autonomous institutions with this separate will that are capable of incurring legal responsibility. while the overarching idea of autonomy can be a useful one, it is quite broad. a more concrete idea can be found in legal personality, which identifies subjects of international law capable of possessing rights, duties, powers and, crucially, obligations and liabilities of their own accord, and distinct from those of its member states. this firmer legal concept can be aligned with the idea of identifying a separate will of an organisation; in addressing autonomy and the idea of a distinct klabbers ( ), at p. ; sari ( ) . white ( ) , at p. . will, many commentators focus on the presence (or absence) of legal personality. personality is important not only in identifying a distinct identity on the part of the organisation, but it also in establishing whether an organisation has the capacity to incur responsibility as a distinct actor on the international stage. in spite of personality being slightly more concrete than the overarching idea of autonomy, there does not exist a clear definition of personality in international law. international law is largely state-centric, and states are presumed to have legal personality by their very nature; but the expansion of personality beyond the state has not led to a clear definition. institutions were first accepted as having the capacity for legal personality by the international court of justice in "reparations" in relation to the united nations in : in the opinion of the court, the organisation was intended to exercise and enjoy, and is in fact exercising and enjoying functions and rights which can only be explained on the basis of the possession of a large measure of international personality and the capacity to operate upon an international plane. in spite of this acceptance, identifying personality continues to be complex. the above statement, while utilised by many as a definition, has long been criticised, both in terms of its mention of a 'degree' of personality when such a concept is a discrete one, and also in terms of its circularity. this criticism has given rise to continued debate as to precisely how to establish personality. in spite of the criticism, an engagement with the concepts in the statement, while somewhat difficult, becomes almost inevitable. the important consideration begins with the intentions of member states, primarily those intentions explicitly mentioned but also, building from this, implicitly derived through the actions, powers and organs of the institution in an attempt to identify this broad notion of a 'distinct will'. ensuring the intentions of the member states may be a useful starting point, but this approach is limited when applied to multi-layered, multi-faceted supraorganisations such as the un or the who; the intentions of the member states very often are not stated or are unclear. indeed, the role, functions, and powers of such organisations are organic in nature: they grow, shift and develop over time without a conscious statement of the intentions of the member states that are enabling this growth and development. many organisations now differ substantially in role, functions, and powers from those which were created in the post-war era, with much of this development having been unconscious and evolutionary as opposed to explicit member state reform. the consequence is that, to identify personality, intentions are inferred from considering aspects of the institution: such as a degree of permanency and distinct purposes and powers, the existence of organs within the institution with the white ( ) , at p. . reparations for injuries suffered in the service of the united nations, advisory opinion icj reports, , p. . brölmann ( , at p. ; white ( ) , at p. . seyersted ( ) , klabbers ( ) , see in particular, - ; klabbers and wallendahl ( ). capacity for decision making, and the exercise of powers, without the prior approval of the member states. determining the who's personality is slightly more complex than with some other institutions due to its existence as a specialised agency of the un. as with most other international organisations, there is no definitive statement on personality in its founding documents, meaning there was no distinct conferral of personality on the who from the member states at the time of its creation. the reparations statement then directs us to consider a more implicit conferral of personality from the member states; when considering the powers and capacities given to an institution, personality can be identified. the constitution of the who considers its "legal capacity, privileges and immunities", which are to be determined by the who in "consultation" with the secretary-general of the united nations and concluded between the members of the who. while this statement does not state much about personality and capacity, it can be interpreted to show the who to have "legal capacity, privileges and immunities", which could go some way towards establishing personality. it is significant that such capacity is to be "determined" by the organisation itself. this is an important element. the power to develop its own capacity, even to a small degree, shows a significant element of 'separate will' from its members on the part of the institution. moreover, it is interesting that some mention of personality is made in the convention on the privileges and immunities of the specialised agencies, concluded by the un general assembly. this convention, which does apply to the who, makes explicit reference to the institution possessing 'juridical personality', and defines this as the capacity "(a) to contract, (b) to acquire and dispose of immovable and movable property, [and] (c) to institute legal proceedings". in explicitly recognising an aspect of legal personality and in attempting to delimit it in a specific way, the convention recognises that the organisation has the ability to act in a manner that is distinct from its member states. there is an identification of the who as being separate from its members, not just broadly in terms of its actions but in far more legal terms. the considerable expansion of the role, functions, and powers of the who since they were first articulated in only strengthens the case for establishing legal personality and determining the who as an autonomous institution. the member states have allowed the role, functions and powers of the who to move its personality beyond that which was initially envisaged in the founding of the organisation. in the white ( ) words of the icj opinion in reparations this can only be explained by the possession of international personality, and a capacity to operate upon an international plane. while some progress on this argument can be made in relation to the initial idea of will and powers, further support can be found in the institutional structure of the who: it possesses its own organs. under its auspices exist the world health assembly, the executive board, and the secretariat, each of which has a number of distinct powers to act on behalf of the who. the assembly, for example, determines policies and adopts regulations, which can be seen as akin to a legislative process. it is also able to adopt conventions with respect to the objectives of the who. the executive board exists as an executive organ of the health assembly, although it must be noted that it has some degree of independence from the assembly, and thereby from the member states that make up the assembly. for instance, while membership of the board is elected by the assembly, the board does not need to reflect the national membership of the assembly, implying that the board members are acting in a manner that is institutionally distinct from the assembly and the member states. moreover, the board elects its own chair and sets its own rules and procedures, addresses any questions within its competence, sets the agenda for the assembly, and proposes the general programme of work for the assembly to vote upon. each of these powers and duties of the board implies that it is distinct from the assembly and the decision-making powers of the member states that make up the assembly. most notably in this regard however, is the fact that the board has the power to take emergency measures within the functions and financial resources of the organisation to deal with events requiring immediate action. in particular it may authorise the director-general to take the necessary steps to combat epidemics, to participate in the organisation of health relief to victims of a calamity and to undertake studies and research the urgency of which has been drawn to the attention of the board by any member or by the director-general. while the board typically exists to work in harmony with the assembly, and the member states that comprise it, it is clear that it has some degree of independence, particularly when responding to epidemics and calamities such as ebola. the existence of distinct organs in this fashion begins to give further credence to the existence of personality on the part of the who. while the existence of organs in themselves may not be a determining factor, their distinct identity as providing much more than a simple discussion forum for member states can contribute towards the argument of an institution possessing personality. when considering the who's organs, they exist as part of the institution and, most particularly, do so during epidemics the reparations for injuries suffered in the service of the united nations, advisory opinion icj reports, , p. . article , constitution of the world health organisation. article , constitution of the world health organisation. article (h), constitution of the world health organisation. article (f), constitution of the world health organisation. article (g), constitution of the world health organisation. article (i), constitution of the world health organisation. management and prevention of which is one of the key functions of the organisation itself. when considering further powers of the who, its ability to accede to international treaties also gives particular credence to an existence of legal personality. it is particularly telling that the who acceded to the vienna convention on the law of treaties in spite of the existing accession of many of its member states. the report of the secretariat of the executive board on the participation by the who to the vienna convention is interesting in this respect. in this report, drafted by the secretariat, the executive board of the who advises the wha to authorise the director-general of the who to sign the convention. this report clearly discusses the who as an actor distinct from its member states. indeed, many member states of the wha were already signatories to the convention by this stage, the implication being that the membership of its member states was insufficient to bind the who to the convention, and accession by the who as a distinct legal actor was required. this led to the who signing the convention in and giving formal confirmation of its intention to be bound, without reservations, in . all of these points show that the who has the capacity to act in a distinct fashion that is beyond the sum of its parts; it is more than simply a collective of its member states. in existing in this distinct manner and having certain rights, powers and obligations as this distinct actor, it clearly possesses legal personality. the who's legal personality gives it both the capacity to act in certain areas within its remit, but also makes it 'subject to international law', giving rise to the need to provide redress for any issues arising from its actions, or omissions, in the areas within its competence. it has the capacity for legal responsibility arising from its powers. in order to consider any possibility of legal responsibility, however, the existence of obligations over and above powers to act must first of all be found. the identification of obligations on the part of institutions, rather than simply powers to act, has been a difficult one to determine in relation to international organisations. the traditional state-centric international system recognises two main sources of international law: customary principles, and international treaties. how these sources of international law apply to institutions, such as the who, has long been questioned. while the icj has often stated that obligations exist on the part of institutions, a clear identification of such obligations, or even the source of such obligation, is rare. we argue that such a legal obligation does exist on the part of the who in the requirement to declare an extraordinary event a pheic in a timely manner. while this is not stated in explicit terms, we draw upon a number of sources below in more detail to argue this. it must first of all be noted that when examining the ihr and the obligation to declare a pheic, that the language used is not that of the discretionary 'may', but of the obligatory 'shall'. as noted above, a pheic can only be declared by the director-general, on the advice of an emergency committee, which is convened by the director-general. the decision to declare (or not to declare, as the case may be) an event a pheic is one that has significant repercussions for affected states. while the international health regulations provides the director-general with the power to declare an extraordinary event a pheic, we argue that the director-general actually has a legal obligation to declare an event a pheic and to do so in a timely manner. the first element of this obligation to declare may have been eventually fulfilled but (as we will argue in a moment), the failure to declare the west african ebola outbreak a pheic in a timely fashion was not, and therefore constitutes an internationally wrongful act, for which responsibility ought to arise on the part of the organisation. the finalised articles on the responsibility of international organisations establish that in order for responsibility to be established, an internationally wrongful act must be identified. there are two key elements that constitute an internationally wrongful act: a breach of an international obligation, and attribution of that breach to the responsible international actor. could the delay in the declaration of a pheic by the director-general, on behalf of the who, be a breach of an international legal obligation that can be attributed to the institution, resulting in legal responsibility? arguably, it could. in identifying a breach of international law, the commentaries to the ilc's articles provide some guidance as to what will be sufficient; they consider that any source of international law applicable to the organisation will suffice. the ilc elaborates further with reference to the international court of justice (icj) advisory opinion on the interpretation of the agreement of march between the who and egypt, stating that international organisations are bound by any obligations incumbent upon them under general rules of international law, under their constitutions or under international agreements to which they are parties. the legal obligation to declare a pheic is not explicitly identified as an obligation in and of itself within the relevant core documents of the who. rather, numerous obligations are identified within the constitution of the world health organisation, in particular articles (v), (a) and (g) of the functions, and an external agreement with the african congress, which when taken together would create the legal obligation pursuant upon the who to declare the west african ebola outbreak pheic and, secondly, to do so in a timely fashion. we explore these obligations below. the constitution of the world health organisation is the founding document of the organisation and was adopted by the international health conference, a meeting of the economic and social council of the united nations, in . despite the fact that it has been amended four times, the objective and functions of the world health organisation remain largely unchanged from the original text that was approved in . the simple, if somewhat lofty, objective of the world health organisation is 'the attainment by all peoples of the highest possible level of health.' the constitution of the who also outlines the manner in which the who intends to meet this objective and ensure all peoples attain the highest possible level of health via the 'functions' provided at article of the constitution. within the functions of the constitution there is no explicit obligation to make a timely declaration of a pheic: indeed, there is no reference to the notion of a pheic in the constitution at all. however, there are obligations pursuant upon the who set out at the functions of the constitution that give rise to an obligation to make a timely declaration of a pheic. the first relevant function that gives rise to an obligation on the who to make a timely declaration of a pheic is contained within article of the who constitution, and requires the who 'generally to take all necessary action to attain the objective of the organisation'. clearly a prompt and effective global response to an epidemic, a response which is instigated by the declaration of a pheic by the who, is needed to ensure all affected, or at risk, persons can attain the highest possible level of health. while this is a broad function of the organisation, and in and of itself it cannot be said to confer upon the who specific and particular obligations in respect of declaring a pheic in a timely manner, when taken in combination with the two further functions outlined below, a compelling case can be made that there is an obligation binding upon the who to declare a pheic, and to do so in a timely manner. the first additional relevant function outlined at (a) of the constitution outlines that the who is 'to act as the directing and coordinating authority on international health work'. the who's role as directing and coordinating authority during a major outbreak such as ebola is typically triggered by a declaration of a pheic by the who. article of the ihr states that a pheic declaration being made triggers the following response from who: for an interesting historical perspective on the development of the constitution see: grad ( further, if the who considers that a pheic is occurring it can assess the severity of the event, the adequacy of support, and offer additional assistance: such collaboration may include the offer to mobilise [sic] international assistance in order to support the national authorities in conducting and coordinating on-site assessments. this process of having the who coordinate and direct the response to an outbreak is crucial in ensuring an effective response from the affected states and the wider international community. a pheic declaration triggers the mechanisms of the who into action, and also directs international attention and resources to the outbreak. a consequence of this is that any pheic declaration must be done in a timely fashion. a pheic works to direct and coordinate action in response to an outbreak, and so a failure to act in a timely fashion will affect the ability to respond to a crisis. this can be seen with comments by the report of the ebola interim assessment panel that during the ebola outbreak the 'who not only coordinates the health cluster, but is also responsible for the coordination of specific technical activities such as surveillance. in the ebola crisis, who should have had a key role to play in coordination, but it took a long time to get this started.' the second relevant function of the who that could give rise to there being an obligation to declare a pheic in a timely fashion is 'to stimulate and advance work to eradicate epidemic, endemic and other diseases'. clearly this cannot be adequately achieved without the timely declaration of a pheic by the director-general. as noted above, a pheic declaration not only triggers the mechanisms of the who, but also directs international attention and resources to the outbreak-resources that are key to controlling or eradicating disease. these functions, which are binding upon the who through its constitution, give rise to international obligations, which in turn are binding upon the who itself. when these obligations are taken together, the natural consequence is an obligation to declare a pheic when the appropriate circumstances arise, and to make said declaration in a timely fashion. the who is the coordinating authority on global health and, from its constitution, possesses obligations to work towards the eradication of disease and to pursue the highest possible level of health. these obligations cannot be satisfied without the timely declaration of a pheic. hence, it would appear that the internal obligations stemming from the constitution of the who are sufficient to create a legal obligation pursuant upon the who to declare a pheic in a timely fashion when it appears right to do so. moreover, this legal obligation stemming from the constitution is not limited to the west african ebola outbreak, but any other extraordinary event that meets the criteria to be declared a public health emergency of international concern. this obligation may be bolstered by external agreements to which the who is a party as part of its external relations. in the case of the west african ebola outbreak, in addition to the internal obligation stemming from the constitution, there was an external obligation on the who to make a timely declaration of a pheic. this is derivable from the membership of the african union of sierra leone, guinea, and liberia, the states that were most seriously impacted by the outbreak, with which the who signed an agreement in . the who's agreement with the commission of the african union includes an obligation "to contain […] crises and outbreaks of disease, and impart […] knowledge and skills". the declaration of a pheic is envisaged to address "a public health risk to other states through the international spread of disease" and, consequently, an obligation to contain crises and outbreaks of disease ought naturally to give rise to an obligation to utilise any legal tools that may assist with this. a pheic declaration is clearly a central tool through which this obligation is fulfilled. not only is there a general obligation to declare a pheic when appropriate in a timely fashion, but the who-au agreement created an obligation upon the who to do as much as possible to contain disease outbreaks in african union member states which would clearly include declaring a pheic where appropriate. this is an obligation that was clearly not fulfilled in respect of the west african ebola outbreak. the central aspect of a pheic is the actions that may arise from it. a pheic declaration not only triggers the mechanisms of the who outlined above, but also directs international attention and resources to the outbreak-resources that are key to the control or eradication of disease. in the case of the ebola epidemic, the pheic declaration did not occur until august th, over six weeks after médecins sans frontières had warned that ebola was 'out of control', and had called for a 'massive deployment of resources'. senior staff at the who had also raised the prospect of declaring a pheic, but it was resisted. as gostin and friedman noted, international donations, technical assistance and military assistance finally began to flow to the region only after the pheic was declared. this was despite the fact that the who had briefed the international community on the seriousness of the outbreak from th april, with increasing emphasis being placed on the severity of the outbreak up to the point a pheic was declared. it is clear that a pheic declaration was appropriate in this instance. as such, the appropriate and timely declaration of a pheic is central in ensuring the obligations for preventing crises and spread of disease mentioned both generally within the who constitution, and specifically in world health assembly, "agreements with intergovernmental organisations: agreement between the commissions of the african union and the world health organisation" ( ) a / . médecins sans frontières ( ) . cheng and satter ( ) . lawrence gostin & eric friedman, (n ). world health organisation ( c) at 'chapter -key events in the who response to the ebola outbreak'. the particular agreement between the who and the au. the failure to declare a pheic in a timely fashion is capable, therefore, of giving rise to responsibility and the specific legal principles on this will now be considered. while the who did declare a pheic in relation to the west african ebola outbreak, thereby satisfying the first stage of their legal obligation, that declaration was not timely, and therefore did not satisfy the second stage of the obligation. timely in this context should be flexible in its application to individual circumstances-a set period of time cannot be attached to it, but rather reasonableness with regard to all the circumstances should be the guiding principle. the period between the criteria for declaring a pheic having been met and a declaration being made ought to be as short as possible and with no unjustifiable delay. ultimately, questions of timeliness will be resolved by determining if the director-general could have acted more quickly in declaring a pheic once the criteria for doing so had been satisfied. in relation to ebola the declaration of a pheic was not timely, inasmuch as that there were no justifiable reasons for this delay. the who was originally notified of the outbreak on rd march but, as we have seen, it was not until th august that a pheic was declared. by the time a pheic was declared there were confirmed and suspected cases of ebola, nearly a thousand of which were confirmed or suspected to have resulted in death. the ebola interim assessment panel, set up by the who itself, stated that there were "significant and unjustifiable delays" in the declaration of a pheic by the who. furthermore, when examining the communications about the ebola situation, it is clear that in the time between the who being made aware of the ebola crisis and its decision to declare a pheic, numerous individuals and bodies with expertise in this area were arguing that the situation was a severe one that required further action and attention from the who. internal who communications show clear concerns about the severity of the outbreak and the lack of action on the part of the who, including the virus spread being worse than the data implied and continued pleas for assistance from staff on the ground not being answered, as well as refusals to consider convening an emergency committee, which would begin the process of declaring a pheic. these communications show that there was a two-month delay from the who having become aware of the severity of the outbreak in west africa to who ( ). world health organisation, (n ). associated press, "emails show who resisted declaring ebola an emergency," nbc news (nbc news), march , , accessed may , . http://www.nbcnews.com/storyline/ebolavirus-outbreak/emails-un-health-agency-resisted-declaring-ebola-emergency-n . an emergency committee being convened. taking two months to begin to move towards the process of declaring a pheic is not plausibly timely, especially when taken together with the knowledge of how severe the outbreak was becoming. in order for responsibility to be established, any breach of international law must be attributed to the international actor concerned. it is the requirement of attribution that is often problematic when considering international organisations. the transparent nature of institutions means that it is often difficult to determine with certainty the action as being that of the institution. action is often carried out by member states on behalf of the institution and determining that an action is that of the institution as opposed to the state is complex. the declaration of a pheic is, arguably, an exception to this difficulty. the basic rule of attribution in the ario is that all actions of an organ or agent of the institution are attributed to that institution. a substantial critique of the ario has been that this is limited in its application as institutions often depend upon their member states to carry out their actions and obligations. when considering the actions of the who in these circumstances, however, it is clear that it is the 'pure' institutional organs and agents that are being considered. the decision to declare a pheic is one that lies with the director-general of the who. as the director-general is clearly an agent of the who and not acting on behalf of a member state of the organisation, any failure to declare a pheic in a timely fashion will be attributed to the who through agency. with the elements of breach and attribution being satisfied in respect of the failure to declare the west african ebola outbreak a pheic in a timely fashion, there exists an internationally wrongful act, attributable to the who through an agent of the organisation, for which responsibility on the international stage can be established. in spite of the clear ability to determine responsibility in this regard, it should be noted that enforcing this is far from straightforward. there are numerous practical limitations to finding and giving effect to any determination of responsibility in relation to an international organisation like the who. not only is there a question about a lack of judicial fora before which cases on breach of international law by international organisations could be brought, but there is also the question of practical consequences arising from actions before such courts, if one with appropriate jurisdiction could be identified. a determination of responsibility gives rise to an obligation to make reparation. the extent to which this is possible in the present case, both in terms of enforcement, and of where any money would be drawn from in order to make such reparation, is highly questionable. regarding enforcement, there does not exist an identifiable court before which the who could be taken by a state, or indeed an individual or institution affected by the who's omissions in the present case, to enforce the determination of responsibility. this is one of the fundamental weaknesses of responsibility in relation to international organisations; there are few, if any, possibilities in terms of judicial fora. when considering the case law that has discussed the principles contained in the ario, it is notable that all of them return to the responsibility of a state, after engaging with the ario principles in respect of the relevant institutions in order to 'discount' the institution concerned, return to the responsibility of the states concerned. it is difficult to conceive of a case where the responsibility of an institution could be explicitly determined and later enforced. this is all before considering the difficult question of immunity, which is a principle that has continued to block numerous cases considering the responsibility of the united nations. while there are questions about the existence and nature of institutions' immunity, including discussions about whether they are absolute or limited, most consider the un to possess an absolute immunity from prosecution in line with article ( ) of the un charter, together with section two of the convention on privileges and immunities of the united nations ( ), which states: the united nations, its property and assets wherever located and by whomsoever held, shall enjoy immunity from every form of legal process except insofar as in any particular case it has expressly waived its immunity. while it was established early on that such prosecution was in relation to national law and did not preclude international responsibility, the lack of an international judicial system has necessarily meant that these questions arise in national courts. with the questions arising in relation to national law, immunity arises time and again. furthermore, the who constitution states that [t] he organisation shall enjoy in the territory of each member such privileges and immunities as may be necessary for the fulfillment of its objective and for the exercise of its functions. the un general assembly concluded the convention on the privileges and immunities of the specialised agencies that explicitly included the who within its remit. although the international court of justice is seemingly given some remit for action by the constitution of the who, and also specifically within the convention on privileges and immunities, this is substantially limited when read together with provisions of the statute of the icj. only states are able to be parties to adversarial proceedings before that court. any proceedings involving international organisations can only be heard by the court in the remit of an advisory opinion, in respect of interpreting international law, not enforcing it. overall, it appears that the ability to establish responsibility judicially is highly limited; the remit of the icj is restricted and all attempts to bring cases in national courts have resulted in immunity preventing any action proceeding against the international organisation. while there have been some limited examples of litigants looking beyond immunity where not to do so would lead to a 'denial of justice', this appears to be a highly limited approach largely addressing private law cases; cases beyond this in the sphere of public law have seen continual deference to immunity, in particular in relation to the united nations. in the present case, the who is privilege to the same immunity and protection from legal action as the un. the funding of reparation is a more complex issue that returns, again, to the difficult nature of the identity of an international organisation. institutions are dependent for their budget upon their member states, and a call for reparation raises a number of difficulties. it must be considered whether the institution would pay for such reparations out of its general budget, or whether it would be feasible for it to call upon member states to contribute to a special fund in order to fulfill its reparation obligations. the difficulties surrounding this can be seen with the issues arising from the outbreak of cholera in haiti, and the attempt by the un to set up a compensation fund in response to the outbreak : there continues to be uncertainty surrounding how this fund will be paid for. the un has sought to address two main parts within this fund, one aspect being compensation for the victims and another being about eradication and prevention. there is a target for $ million for each of these parts. however, it was initially unclear whether this should be funded from the general budget or from member state contributions. the approach eventually taken by the un was to rely upon voluntary donations from member states. the consequence of this was that the fund never reached anywhere near $ million, and is currently at risk of running out completely. while it is important to ensure that the who follows its international obligations, it is questionable whether the imposition of legal responsibility, without immunity, would be effective in encouraging the who to engage in its role at the global level. if there arises a concern that its actions may result in determinations of responsibility, this may result in a more cautious approach by the who out of fear of liability being imposed through the law of responsibility. this may end up amounting to a disincentive on the part of the institution to act and develop. even where an institution has developed a significant amount of autonomy, it remains dependent upon its member states for expansion and development. if the consequence of developing an institution has been that member states have been subjected to greater requirements for payment and effective obligations for reparations then this will only discourage the development here. there are huge potential benefits in the development of institutional frameworks and the ability that they have to address global issues, such as that of global health and, in this circumstance, epidemic and pandemic emergencies. it has to be asked whether a framework that may prove a disincentive on the part of states to act and enable global action is really the best approach here. not only did the practical limitations to imposing liability on the who for the mismanagement of the pheic declaration during the west african ebola outbreak serve to shut down any discussion of legal restitution from the who, but an opportunity to acknowledge the situation and make a step towards remedying it was lost. the who has developed significantly since its inception in . its role and powers are far beyond what was originally envisaged. as the organisation has evolved it has become increasingly distinct from its member states, meaning that it now possesses a substantial degree of autonomy to act in an independent manner. furthermore, the who has developed to face a number of obligations, as well as powers. however, this development has not been accompanied with any development of the who's internal accountability mechanisms, nor any meaningful engagement with external accountability and responsibility mechanisms. since the revisions to the international health regulations, the manner in which the who has responded to a number of pheics, and potential pheics, has been subject to considerable criticism from member states and the academic literature. it is our contention that on at least one occasion the who, in responding to an extraordinary event that likely constitutes a pheic, has breached its legal obligations to declare such an event a pheic in a see: united nations ( ) . eccleston-turner and mcardle ( ) . see (n ). timely manner. this has been demonstrated most clearly with the who's delayed response to the ebola outbreak in west africa during the outbreak. the argument we have presented in respect of the timely declaration of a pheic being a legal obligation of the who is not limited to ebola. it applies equally to any other extraordinary event where the criteria for declaring a pheic have been met. this area becomes further complicated when we consider not only the timely declaration of a pheic as being an international legal obligation for which responsibility can be attributed to the who, but also the appropriate, timely downgrading of a pheic's status once the extraordinary event no longer meets the criteria to be considered a pheic. this again, is a decision that is delegated to the director-general via the ihr, and one that has been subject to criticism for its usage. it is arguable that not only is the timely declaration of a pheic a legal obligation binding upon the who, but also that the timely and appropriate downgrading of a pheic amounts to a legal obligation binding upon the who (though the full development of that point is beyond the scope of this chapter). in spite of the ability to make a legal determination of responsibility, this is highly unlikely to result in any sort of legal consequences. there is a substantial number of practical barriers that stand in the way of determining legal responsibility of an international organisation, from lack of judicial fora, to the principle of immunity and the difficult question of how to fund claims for reparation. a legal determination of responsibility in a judicial setting remains highly unlikely. therefore, a productive move forward would be a clear and unequivocal acknowledgement of wrongdoing on the part of who when mistakes are made and the further development of accountability mechanisms. while this is highly limited, and the examples that do exist of institutions acknowledging wrongdoing have a number of substantial flaws, the possibility exists for institutions such as the who to develop internal mechanisms that work and allow some redress. overall this will only improve the who's position in the global community and its work with its member states to develop better responses to disease outbreaks. united nations, statute of the international court of justice application no. / , judgment of february , and application no. / , judgment of claimant et al. and the mothers of srebrenica v the state of the netherlands and the united nations case number c/ / /ha za - , judgement of the hague district court chairman of the sub committee on state responsibility global health security and the international health regulations the international ebola emergency the institutional veil in public international law: international organisations and the law of treaties most notably the yellow fever pheic in which the who faced considerable criticism for its early downgrading of yellow fever from a pheic emails: un health agency resisted declaring ebola emergency accountability, international law, and the world health organisation: a need for reform? special rapporteur, relations between states and inter governmental organisations, document a/cn. / and add. , contained in ilc yearbook after bringing cholera to haiti, u.n. can't raise money to fight it the future of the world health organisation: lessons learned from ebola ebola: a crisis in global health leadership middle east respiratory syndrome: a global health challenge the preamble of the constitution of the world health organisation the rights of war and peace accountability of international organisations learning from ebola virus: how to prevent future epidemics peacekeepers as perpetrators of abuse. examining the un's plans to eliminate and address cases of sexual exploitation and abuse in peacekeeping operations international legal aspects of the european union. the hague, kluwer klabbers j ( ) autonomy, constitutionalism and virtue in international institutional law research handbook on the law of international organisations the emerging zika pandemic: enhancing preparedness ebola in west africa: epidemic requires massive deployment of resources the definition of responsibility in international law international organisations and the idea of autonomy: institutional independence in the international legal order international personality of international organisations: do their capacities really depend upon their constitutions? strengthening the detection of and early response to public health emergencies: lessons from the west african ebola epidemic ebola virus disease in west africa-the first months of the epidemic and forward projections united nations treaty collections: vienna convention on the law of treaties between states and international organisations or between international organisations united nations united nations haiti cholera response multi-partner trust fund launched un haiti cholera response multi-partner trust fund. united nations ebola data and statistics: situation summary, world health organisation world health organisation executive board eb / th session participation by who in the vienna convention on the law of treaties between states and international organisations or between international organisations who statement on the meeting of the international health regulations emergency committee regarding the ebola outbreak in west africa report of the ebola interim assessment panel key events in the who response to the ebola outbreak key: cord- -daz vokz authors: devereux, graham; matsui, elizabeth c.; burney, peter g.j. title: epidemiology of asthma and allergic airway diseases date: - - journal: middleton's allergy doi: . /b - - - - . - sha: doc_id: cord_uid: daz vokz nan epidemiology is the study of the distribution of disease in populations. it is essential for assessing the spread and burden of disease. it is the appropriate method for understanding the cause and pathogenesis of disease. research into allergy has had a long history with many changes in direction, and the language that has been developed to describe what has been found has changed over time. this can lead to confusion. in this chapter, we use the term sensitization to indicate the production of immunoglobulin e (ige) antibodies in response to allergens. we use the term allergy to refer to the presence of one or more diseases associated with ige sensitization, the most common of which are asthma, eczema, and rhinitis. the term atopy was originally introduced to account for the observation that the main allergic diseases occurred in the same families and appeared to have a common origin. however, it is often used synonymously with the term allergy. test standards. good tests should possess reliability and validity. a test is reliable if it always gives the same answer when applied under similar circumstances. validity implies that the result of the test coincides well with the true condition of the person being tested. validity has two components: sensitivity, which is the ability of the test to identify an existing condition, and specificity, which is the ability to identify as normal people who are free of the condition. measuring the validity of a test for a condition that is poorly defined, such as asthma, is a problem because it presupposes a gold standard test with which the proposed test can be compared. although validity in an absolute sense may always be contested, what is as important in epidemiologic studies is standardization, meaning that the test is identical wherever and by whomever it is administered. validity is essential to the measurement of absolute prevalence, but in many epidemiologic studies, we are as interested in relative prevalence, such as relative prevalence between age groups, countries, or districts, or differences between people exposed to various environmental or genetic risks. standardization is essential for this, and considerable effort has been made to provide standardized measures, particularly for international studies. tests of sensitization. sensitization can be assessed directly by determining the presence of specific ige to allergens in serum. in many places, mites, grass, and cat allergens are among the most common allergens, and most sensitized individuals can be identified by testing for relatively few allergens. , some test kits can identify a mixture of several allergens. in the past, they have been used to test for the occurrence of sensitization, and this may be cost-effective, but it leaves unclear which allergens are » epidemiology is the study of the distribution of disease and, by extension, its causes and consequences, mostly in general populations. » the rates of allergic sensitization and allergic diseases have been increasing, although the increase in prevalence of allergic diseases has slowed among children. » allergic disease is less common in rural parts of low-income countries, although allergic sensitization can be common in these areas. » there has been very little success in explaining the increased prevalence of allergic disease, although it has been linked to urbanization. the great changes observed in prevalence and distribution strongly suggest a major role for the environment. » factors that initiate allergy and allergic diseases should be differentiated from factors that exacerbate them after they have been established. » allergies are affected by environmental factors, including diet; exposure to a normal, diverse microflora; infections; exposure to air pollutants; and occupational exposures. » allergy is not associated with higher mortality rates or loss of lung function, but asthma is associated with both. » outcomes for asthma can be considerably improved by good management. test of whether someone had asthma. what had been provided was, in his view, no more than a description. second, he pointed out that most diseases were concepts rather than "things" and that their definitions were therefore bound to be contested. since then, there have been many attempts to define asthma (table - ) , although most have paid little attention to the issues raised by this led to more complicated descriptions but not to any greater clarity. some have introduced additional assumptions about mechanisms and causes. despite these strictures, asthma has been an enduring and trusted concept clinically, but a separate question remains about how the condition can be identified in epidemiologic studies. there are effectively three broad methods of identifying asthma in surveys: questionnaires asking about diagnosed asthma, questions about the symptoms of asthma, and physiologic tests of airway responsiveness. questions asking whether someone has asthma, often qualified by asking whether a doctor has ever confirmed the diagnosis, are common. they are regarded as highly specific, meaning that there are few people who answer this question in the affirmative but do not have asthma, but there are many people who may be defined as asthmatic who deny that they have the condition. the worst characteristic of these questions is the lack of standardization. the answers to the questions depend on local medical practice and the terms used by health professionals when talking to patients. variations in the use of the term asthma likely have influenced estimates of time trends and observed differences in mortality between countries. over the past years, the prevalence of people with asthma has increased markedly, and there has been much debate about whether this can be explained by differences in the way the term has been used. this possibility is supported by the encouragement given to pediatricians, particularly from the s onward, to diagnose all wheezy children as asthmatic because this would encourage the use of medication and was shown to enhance the quality of life of children regardless of the exact diagnosis. in the s, kelson and heller sent scenarios of patients who had died to a representative group of physicians signing death certificates in several european countries. one scenario (box - ) described a person who had some symptoms of asthma but many of the features of chronic obstructive lung disease. figure - shows the relationship between the proportion of the physicians in each country ascribing this death to asthma and the national mortality rate for asthma. there is a strong suggestion that the way doctors in each country view such marginal cases may be influencing the national mortality data. whether this is still the case is uncertain. since then, there has been a major increase in international consensus documents. asking about symptoms rather than diagnosed disease avoids some of these problems, and efforts have been made to find suitable questionnaires and to standardize them across countries. the most commonly used questionnaire for children is that developed for the international study of asthma and allergies in childhood (isaac). for adults, the questionnaire developed for the international union against tuberculosis and lung disease (iuatld) , was subsequently adapted for use in the european community respiratory health survey (ecrhs) and was further adapted for the world health survey. responsible for symptoms. microchip technology and the development of recombinant and purified allergens have enabled testing for several allergens simultaneously and allowed more precise identification of the relevant allergens. the technology remains expensive and is not widely used in epidemiologic studies. an alternative method of identifying sensitized individuals is to undertake skin-prick tests. they do not require a laboratory and do not involve taking blood. the technique involves introducing a small amount of allergen under the outer layers of the skin using a needle or lancet and reading the size of the wheal that appears in the minutes after the test is applied. this is compared with the wheal produced by a control solution (usually the diluent in which the allergens have been dissolved) and with a positive (usually histamine) control that tests whether the skin is able to respond to the release of mediators that the allergen induces. skin tests have more operatordependent variation than serologic tests, because they are influenced in part by the technique of the technician, but they typically are cheap and provide an immediate answer, which can be more satisfactory for the patient or participant. the criterion for a positive test result varies according to the purpose of testing. using any test greater than the diluent control is more repeatable and less prone to observational error and reflects well the presence of allergen-specific ige. however, in a clinical context, small wheals are rarely associated with allergic disease that can be ascribed to that allergen, and in a clinical context, wheals less than mm in diameter usually are discounted as irrelevant. defining the prevalence of sensitization in a population depends to some extent on which allergens are tested. in western europe and the united states, there is little change in overall prevalence after five or six allergens have been included in the panel. , although less is known about other countries, mite allergens appear to be widespread in tropical and subtropical areas. for the most part, skin tests and serologic tests for sensitization give similar results when technical failures and differences between allergens are taken into account. however, they are not equivalent. skin tests also depend on the ability of mast cells to degranulate and for the skin to respond to histamine. when skin test results are negative, clinical allergy is unlikely even in the presence of specific ige. modern attempts to define asthma start with the ciba guest symposium of on the terminology, definitions, and classification of chronic pulmonary emphysema and related conditions. the symposium defined asthma as "the condition of subjects with widespread narrowing of the bronchial airways, which changes its severity over time spontaneously or under treatment, and is not due to cardiovascular disease". it further identified the clinical characteristics as "abnormal breathlessness, which may be paroxysmal or persistent, wheezing, and in most cases, relief by bronchodilator drugs (including corticosteroids)." soon after the publication of this report, scadding, one of the contributors to the symposium, made two important points. first, what had been described as a definition in the report was not a true definition in that it did not provide a clear year definition ciba foundation condition of subjects with widespread narrowing of the bronchial airways, which changes its severity over short periods spontaneously or during treatment american thoracic society disease characterized by increased responsiveness of the trachea and bronchi to various stimuli and manifested by widespread narrowing of the airways that changes in severity spontaneously or as a result of therapy world health organization (who) chronic condition characterized by recurrent bronchospasm resulting from a tendency to develop reversible narrowing of the airway lumina in response to stimuli of a level or intensity not inducing such narrowing in most individuals american thoracic society clinical syndrome is characterized by increased responsiveness of the tracheobronchial tree to a variety of stimuli. major symptoms are paroxysms of dyspnea, wheezing, and cough, which may vary from mild and almost undetectable to severe and unremitting (i.e., status asthmaticus). primary physiologic manifestation of this hyperresponsiveness is variable airway obstruction, occurring in the form of fluctuations in the severity of obstruction after bronchodilator or corticosteroid use, or increased obstruction caused by drugs or other stimuli, as well as evidence of mucosal edema of bronchi, infiltration of bronchial mucosa or submucosa with inflammatory cells (especially eosinophils), shedding of epithelium, and obstruction of peripheral airways with mucus. nhlbi/nih lung disease with the following characteristics: ( ) airway obstruction that is reversible (but not completely in some patients) spontaneously or with treatment, ( ) airway inflammation, and ( ) increased airway responsiveness to a variety of stimuli. nhlbi/nih , chronic inflammatory disorder of the airways in which many cells play a role, particularly mast cells, eosinophils, and t lymphocytes. in susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness, and cough in early morning. symptoms are usually associated with widespread but variable airflow limitation that is at least partly reversible spontaneously or with treatment. inflammation also causes an increase in airway responsiveness that is associated with a variety of stimuli. nih/nhlbi chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. the chronic inflammation causes an increase in airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. these episodes are usually associated with widespread but variable airflow obstruction that is often reversible spontaneously or with treatment. nhlbi/nih, national heart, lung, and blood institute/national institutes of health. symptom questionnaires do not have the disadvantages of reported diagnoses, but they have problems of their own. first, used alone, symptoms are rarely diagnostic of a condition. this may not be a serious problem when there is no need for an accurate diagnosis in every case, but some symptoms are highly nonspecific. there may be considerable crossover of symptoms between different airway diseases such as asthma and bronchitis. second, the interpretation of similar symptoms may vary among different people. this may become a serious problem when making comparisons in the settings of different cultures and languages. in translating asthma questionnaires, there may be particular problems in translating terms such as wheeze when there may not be an equivalent word, and even people who speak the same language may interpret wheeze differently. given the lack of a gold standard to test these questionnaires against, their validity cannot be fully assessed, because it depends in part on whether they are seen as plausible indicators of the presence of asthma and standardization against a plausible alternative indicator. in the iuatld questionnaire, this indicator was the airway response to histamine, which usually increases tests. they have some of the same limitations as reversibility testing. more promising has been the use of bronchial challenge tests, most of which use a direct bronchoconstrictor such as histamine or methacholine. lung function is assessed before and after inhaling increasing doses of the agent. the decline in lung function (usually the forced expiratory volume in second [fev ]) is regarded as a marker of asthma. , this may be expressed as the dose or concentration of agent that produces a given (often %) fall in lung function, in which case the result usually is dichotomized as those falling by at least that amount (i.e., hyperresponsive) and those that do not (i.e., normal). alternatively, the slope of the dose-response curve has been used as a continuous measure of airway reactivity, a method that uses epidemiologic information more efficiently but may be clinically less intuitive. development of these tests for use in surveys has provided a tool for assessing a physiologic measure associated with asthma. there is little difference between the use of histamine and methacholine, but methacholine is more widely used because it has fewer side effects. one disadvantage of nonspecific challenge tests is that they produce positive results for those with asthma and also with chronic obstructive pulmonary disease (copd). , this has led to the use of alternative agents that act indirectly by releasing mediators from mast cells in the airway. challenge agents include adenosine, hypertonic solutions (e.g., saline, mannitol), exercise, and cold, dry air. these alternatives have not been used as widely as methacholine. exercise testing usually has been confined to studies of children. its effects depend on weather conditions (e.g., cold, dry conditions produce a greater stimulus than warm, moist conditions), and it requires well-motivated groups of participants. equipment to provide cold, dry air has not been widely available. use of saline and mannitol has promise, but they have not been widely used in surveys. the theoretical advantage of using these methods is that they are less likely to provoke airway constriction in those with copd. allergic rhinitis has been investigated much less frequently than asthma using epidemiologic approaches. population-based studies are made difficult by misclassification arising from reliance on questionnaires to establish the presence of allergic rhinitis. typically, the questionnaires used by epidemiologists ascertain self-reports of responders having something they call allergic rhinitis or hay fever. nonetheless, studies show that allergic rhinitis is among the most common chronic diseases. symptoms of individuals with rhinitis include sneezing, nasal irritation, rhinorrhea, and nasal blockage. these symptoms can also involve the eyes, ears, and throat, including postnasal drainage. allergic rhinitis is most commonly classified as seasonal, perennial, or occupational, but a recent guidelines statement advocated classifying allergic rhinitis as intermittent or persistent. the symptoms of allergic rhinitis are associated with exposure to allergen sources such as pollens, pets, and house-dust mites (hdms). symptoms result from inflammation induced by a specific ige-mediated immune response to the allergens. criteria for diagnosing chronic rhinosinusitis have been published. , a questionnaire based on the symptomatic part of this definition has been devised and tested for epidemiologic surveys. in patients with asthma. although it is not diagnostic of asthma, it is reassuring to find that answers to the questionnaires can predict the results of the alternative test and that they can do this in approximately the same way in different countries and different translations. for the isaac questionnaires, a video was developed that demonstrated the symptoms of asthma, and it was used to help standardize comprehension of the questionnaire in different settings. although fully validated questionnaires for diagnosing asthma are not available, the current questionnaires do allow comparison of symptoms that plausibly represent conditions close to asthma in a standardized way. although cautious interpretation is always advisable, they have enabled substantial advances in our knowledge of the relative distribution of the condition. an objective test for asthma that did not depend on interpretation of questionnaires would be ideal, and several tests have been proposed. the lack of a gold standard for diagnosing asthma and the similarity of asthma to other conditions make a perfectly validated test unattainable, but tests do provide additional tools to check the findings of surveys that use questionnaires only. the physiologic tests for asthma have been based on the definition of asthma as a condition of the airways that changes its severity over time spontaneously or after treatment (box - ). reversibility of airway obstruction after use of a bronchodilator (i.e., reversibility testing) has been used in clinical studies to distinguish between asthma and fixed airway obstruction, and some have used it as a test in surveys to identify asthma. the difficulty lies in interpreting the results. a positive test result indicates the likely presence of asthma, but a negative test result is uninformative. because a patient with asthma who is receiving good treatment or in remission for some other reason does not respond to a bronchodilator, this approach has not found much use in surveys of the general population. spontaneous changes in airway caliber can be assessed using peak flow diaries, a clinical technique that has been commonly used in primary care in the united kingdom. although they can be difficult to use in large-scale studies, they do provide data comparable to that using more invasive bronchial challenge kingdom, and the netherlands. low prevalence rates were found in spain, iceland, and italy. the second phase of the isaac study estimated the prevalence of positive skin-prick test responses to at least one of six allergens in children between the ages of and years living in sites, mostly in western europe. , estimated prevalence ranged from . % in tallin, estonia, and . % in mumbai, india, to . % in rome, italy, and . % in almeira, spain. unlike in western countries, the prevalence of sensitization in africa heavily depends on the methods used to assess sensitization. in rural areas, the prevalence of positive skin-prick test results is very low, whereas the prevalence of allergen-specific ige is high. the high prevalence of allergen-specific ige in poor rural areas was first shown in zimbabwe (formerly called southern rhodesia) by merrett and associates, but the dissociation in these environments between specific ige levels and skin test results also has been shown in kenya and south africa. where skin test results are negative, even in the presence of specific ige to aeroallergens, clinical allergy is rare. asthma is a global problem. it is estimated that approximately million people worldwide have asthma. prevalence rates for children and adults are substantially different in countries around the world. the first phase of the isaac study provides the most extensive information on variation in childhood asthma prevalence. in , the isaac steering committee reported findings for , -to -year-old children ( centers in countries) and , -to -yearold children ( centers in countries). for the younger and older children, the prevalence of asthma symptoms was based on a positive response to this question: have you had wheezing or whistling in the chest in the past months? across countries, there was an approximately twentyfold range of prevalence, with the highest rates usually found in more developed countries (figs. - and - ) . the countries with the highest prevalence rates (> %) were the isle of man, the united kingdom, new zealand, ireland, australia, peru, panama, costa rica, the united states, and brazil. the ecrhs assessed geographic variation in asthma among , adults from countries. a sixfold variation in the prevalence of current asthma was found among the countries. a high (> %) prevalence of asthma was found in australia, new zealand, the united states, ireland, and the united kingdom. asthma prevalence of less than % was found in iceland, parts of spain, germany, italy, algeria, and india. current asthma was defined in the ecrhs as "having an attack of asthma in the past months or currently taking medicine for asthma." the ecrhs did not examine many sites outside the developed market economies, but the world health survey interviewed adults older than years of age in six continents using questions derived from the ecrhs on wheezing and diagnosed asthma. the prevalence of diagnosed asthma ranged from . % in vietnam to . % in australia (fig. - ) . a very wide variation in the prevalence of diagnosed asthma (and wheezing) was found in all countries, regardless of gross national income per capita adjusted for purchasing power parity. in countries eczema similar to allergic rhinitis, the epidemiology of eczema is less well understood than the epidemiology of asthma. eczema, also known as atopic dermatitis, is a pruritic rash characterized by chronic, recurrent papular lesions typically affecting skin at the flexor surfaces, buttocks, and back of the neck. infants frequently have involvement of the face. in its acute and subacute forms, eczema is characterized primarily by erythema and a papular eruption, but in its chronic form, it is characterized by lichenification of affected areas. allergic sensitization plays an important role in provoking eczema flares, particularly in pediatric patients. some studies have relied on physician diagnosis to define eczema, but standardized questions have been developed for identifying eczema cases with or without additional information from standardized examination. these questions are included in the isaac questionnaire, and they focus on the chronic and recurrent nature of the rash, its location, and the presence of pruritus. during the past years, food allergy has received increased attention, and there is a growing body of literature available regarding its epidemiology. food allergy is an immune-mediated reaction to a food. it can produce a wide spectrum of clinical manifestations, including acute ige-mediated reactions, mixed ige-mediated and non-ige-mediated reactions that are often characterized by insidious gastrointestinal symptoms, and non-ige-mediated syndromes such as allergic colitis and food protein-induced enterocolitis syndrome. even among patients with acute ige-mediated types of food-allergic reactions, symptoms can vary and include one or many of the following: urticaria, angioedema, pruritus, cough, wheezing, hoarseness, vomiting, diarrhea, oral pruritus, hypotension, and rhinorrhea. because the diagnosis is based on the clinical history and diagnostic test results, with the gold standard being a double-blind, placebo-controlled food challenge, conducting large epidemiologic surveys can be difficult because of reliance on questionnairebased tools for identification of food allergy and evidence of ige sensitization. because there is no validated questionnaire for food allergy and many reported food allergies are not confirmed when a full diagnostic evaluation is completed, estimates obtained from questionnaires are likely to be inflated. the prevalence of sensitization depends on the selection of allergens. for this reason, the relative prevalence of responses to a standardized panel of allergens is more informative than an absolute prevalence. the ecrhs estimated the prevalence of specific ige (≥ . ku/l) to mites (dermatophagoides pteronyssinus), cats, grass (timothy grass), or cladosporium among young adults between the ages of and years in centers, mostly in western europe. the prevalence of a positive response to any of the four common allergens ranged from . % to . % ,with a median prevalence of . %. high prevalence rates were found in australia, new zealand, the united states, the united rates for different questionnaire-based indicators of asthma: physician report, current disease, and the symptom of wheezing used in the national health and nutrition survey of the united states from through . questions that ask about asthma or wheeze provide estimates that are almost twice those of questions asking about either alone, and this difference varies with age. for those between the ages of and years, with the lowest incomes (<us$ ), none of sites had a prevalence of diagnosed asthma of more than %; among countries with intermediate incomes, ( %) of countries had a prevalence higher than %; and among counties with the highest incomes (<us$ ), ( %) of countries had a prevalence above %. the national health interview survey (nhis) and the national health and nutrition examination survey (nhanes) include random samples of the whole u.s. population. both also provide periodic prevalence estimates. standardization of the methods of prevalence surveys is essential because the wording of questions on asthma or other aspects of data collection may affect estimates based on the questionnaires. for example, table - provides prevalence country wheeze is much more likely to be associated with a diagnosis of asthma. state-specific asthma prevalence data for adults are available from the behavioral risk factor surveillance system (brfss), a state-based, random-digit-dialed survey of noninstitutionalized u.s. adults age years or older. it was conducted by the centers for disease control and prevention (cdc) and the state or territorial departments of health. information was gathered from all states, puerto rico, the virgin islands, and the district of columbia. the definition for current asthma was based on providing positive answers to two questions: have you ever been told by a doctor, nurse, or other health professional that you had asthma? do you still have asthma? the overall current asthma prevalence rate was . %, ranging on the mainland from % in tennesee to . % in vermont ( fig. - ) . asthma prevalence rates in the united states vary with demographic and social conditions. figure - gives prevalence rates from the nhis for through . children have more reported asthma than adults, women have more than men, those in poverty have more asthma than those not in poverty, asian respondents reported less asthma than any other group, and all other racial groups have more asthma than white respondents. estimating incidence and prevalence of allergic rhinitis is as challenging as for asthma. the diagnosis is symptom based, and there is no consensus for measurement. some attempts have been made to estimate the incidence of allergic rhinitis using cohort or longitudinal data. in a birth cohort study from germany that followed children for years, % of them developed seasonal allergies, defined as a combination of exposure-related symptoms and sensitization. a % cumulative incidence rate was determined in a -year longitudinal study of college students. the researchers also observed that regression of hay fever symptoms was inversely related to age of onset. almost % of those with hay fever onset before years of age had improvement of their symptoms. the isaac researchers collected data on -month prevalence of allergic rhinoconjunctivitis for children to years old from countries. allergic rhinoconjucntivitis was defined as having a problem with sneezing or a runny or a blocked nose without a cold or flu and accompanied by itchy, watery eyes. there was a thirtyfold variation in the prevalence rate among the sites, from . % to . %. estimates for adults obtained in the ecrhs ranged from . % in algeria to . % in australia. the median prevalence of nasal allergies in the ecrhs was about %. countries with significantly high prevalence rates were the netherlands, belgium, switzerland, france, the united kingdom, new zealand, australia, and the united states. chronic rhinosinusitis is an inflammation of the nose and paranasal sinuses lasting over weeks. another multicenter european study estimated the prevalence of chronic rhinosinusitis using a questionnaire based on the european position paper on rhinosinusitis and nasal polyps (ep os) on symptom criteria to be about % among adults, ranging from % in helsinki, finland, to % in coimbra, portugal. the condition was more common in women, in younger participants, and in smokers. the worldwide prevalence of eczema was best documented in isaac phase three, in which the prevalence for -to -year-old children ranged from . % in india to . % in ecuador. , the worldwide prevalence of eczema in children to years of age has increased in most regions of the world and has remained stable only in western, northern, and eastern europe. for this younger age group, the prevalence in isaac phase three was . %, an increase from the prevalence in phase one of . %. the overall prevalence among -to -year-old adolescents declined to . % in isaac phase three from . % in phase one. the regions with the most striking increases in eczema prevalence were asia and latin america. a growing number of population-based studies have estimated food allergy prevalence and incidence. the prevalence of food allergy and the foods that are most commonly implicated in food allergy vary widely across the world. for example, a metaanalysis found that the self-reported prevalence of food allergy ranged from % to %. although some of the heterogeneity observed is attributable to study methodology, other studies that have focused on specific geographic regions and populations support the notion that there is marked worldwide heterogeneity in food allergy prevalence. for example, in the united states, the estimated prevalence of food allergy is % to % among children, , and in australia, a prevalence of more than % among -year-old children has been reported. in contrast, findings from a population-based birth cohort from the united kingdom indicate that between . % and . % of infants have food allergy in the first year of life, and in other u.k. studies, the estimated prevalence of food allergy among -year-old children is . % to . %, and among adolescents, it is . %. an international study that used allergen-specific ige data for young adults confirmed the heterogeneity of food allergy prevalence observed in the questionnaire-based studies. in this study, prevalence of sensitization to any of foods ranged from . % in iceland to . % in the united states. however, sensitization to the major foods, such as fish, egg, and milk, was uncommon (< %). the incidence and prevalence of allergy to specific foods have been studied. a random telephone survey administered in to estimate the prevalence of seafood allergy in the united states found that . % of the general population reported allergy to fish or shellfish. another telephone survey was conducted in and repeated in and to estimate the prevalence and incidence of peanut and tree nut allergies. , the prevalence rate of peanut or tree nut allergy was stable at . % among adults, but it increased from . % to . % to . % among children during this period. in contrast, data from u.k. general practices were used to estimate a prevalence rate of peanut allergy of . %, and a school-based survey in singapore and the philippines estimated a prevalence rate of peanut and tree nut allergy of less than %. in australia, the prevalence of peanut allergy may be higher than that observed in the united states or united kingdom, because the prevalence of peanut allergy among -year-old children was estimated to be %. there is limited information about the epidemiology of allergic gastrointestinal diseases. however, the incidence and prevalence of eosinophilic esophagitis appear to have increased over the past decade. a range of gastrointestinal symptoms and mucosal eosinophilia characterizes eosinophilic esophagitis. approximately one half of cases demonstrate ige sensitivity to foods. what was once thought to be a rare disease was found people born later in the century having a higher prevalence of disease throughout their lives. in cross-sectional surveys, this pattern of disease is indistinguishable from a decline in disease with age. in the ecrhs, there was almost no net change in the prevalence of sensitization over the years between the surveys within any birth cohort, but succeeding birth cohorts had increasingly high prevalence rates. a subsequent analysis of some british data showed that this phenomenon was apparent in successive birth cohorts since at least the s. to evaluate changes in prevalence, repeated surveys are required for the same populations and using the same instruments for assessment. in the s and s, smith in birmingham, england, first observed that the prevalence of asthma was rising among schoolchildren undergoing school medical examinations. since then, many studies have assessed changes in prevalence. these studies are summarized in figure - , which by one study based in switzerland to have increased in incidence from . to . per , adults from to . , in another study in hamilton county, ohio, the incidence in children younger than years old has increased from . to . % per year, and the prevalence has increased from . % to . % from to . a few studies have made serial assessments of the levels of ige specific to common allergens in the same populations over many years. these studies have shown a fairly consistent increase in the prevalence of sensitization over time. analysis of the data from the tucson and the first and second ecrhs surveys found that the apparent decline in the prevalence of sensitization with age was more easily explained as a birth cohort effect. the apparent effect of age results from . year of survey germany in two surveys made very close together in time and seem unlikely to represent a long-term trend. the isaac reassessed prevalence of asthma and other allergic diseases by questionnaire for -to -year-old children in centers in countries and for -to -year-old children in centers in countries. the results for asthma prevalence are given in figure - . among the younger children, rates were more commonly rising than declining, whereas among the older children, the rising and declining rates were more evenly balanced. among the older children in centers with a high prevalence, the rates were more likely to be declining. in the united states, the nhis, a population-based interview survey of u.s. households, is a key source of information on trends in the prevalence of asthma. before , prevalence estimates were based on a positive response to one question: during the past months, did you have asthma? in , the nchs redesigned the nhis questionnaire. consequently, answers to the nhis questionnaire after cannot be compared with those in previous surveys because the new questions assess asthma morbidity differently. lifetime incidence is measured by this question: have you ever been told by a doctor or other health professional that you had asthma? the prevalence of asthma attacks is obtained by a positive response to another question: during the past months, have you had an episode of asthma or asthma attack? the asthma attack prevalence in was . % for all age groups. in , nchs added a question (do you still have asthma?) after the lifetime incidence question to provide estimates of current asthma prevalence (table - ). the estimates indicate that . % of u.s. residents currently have asthma that has been diagnosed by a doctor or other health professional. table - provides the estimates for asthma prevalence before and after the revisions of the nhis questionnaire. figures - and - show data from the nhis with different estimates of prevalence of asthma over time for children and adults and by race or ethnic group. for children and adults, the -month and lifetime prevalence rates increased over time. current and attack prevalence rates have not shown a marked trend since the use of these outcomes began. prevalence rates also vary among racial and ethnic groups; this variation likely reflects differences in genetic, environmental, social, shows the changes in prevalence over time plotted on a logarithmic scale. most of the studies surveyed children, although a few looked at military conscripts in countries with compulsory military service. the very large variations in the absolute prevalence estimates reflect differences in the definitions used and the populations examined. from the late s to the mid- s, the values rose uniformly at a rate that represented a doubling of prevalence approximately every years, and this occurred regardless of the definition used and the starting prevalence. only in the mid- s did reports begin to suggest that this increase had slowed down. a much smaller number of studies have assessed changes in the prevalence of airway responsiveness ( fig. - ). during the s, a small number of studies showed increases in prevalence over time. [ ] [ ] [ ] [ ] the study of dubois, which showed a yearly increase in prevalence among belgian conscripts over years, is particularly persuasive given the difficulties of standardizing the tests. since the s, most studies have shown a flattening of or a decline in prevalence, [ ] [ ] [ ] although increases were seen in a study from ghana, and a large increase was observed in year prevalence (%) asthma period prevalence current asthma prevalence asthma attack prevalence and cultural influences among population groups. between and , the prevalence of asthma had increased from . % to . % among whites and from . % to . % among blacks, representing cumulative increases of approximately % per annum. between and , rates of current asthma had increased from . % to . % among whites, a cumulative increase of approximately . % per annum, and from . % to . % among blacks, a further increase of approximately % per annum (see fig. - ). many of the studies that reported changes in the prevalence of asthma and wheeze also found increased reporting of other allergic diseases, most notably allergic rhinitis and eczema in children. as for asthma, almost all studies reporting before the mid- s found increases in other atopic conditions with time. since then, results have been more mixed, and the isaac has provided a more representative spread of data than is possible from individual studies. (fig. - ) for the -to -yearold children, most sites showed an increase in prevalence of allergic rhinoconjunctivitis and eczema in the years after the baseline surveys of isaac phase one. for the -to -year-old children, the changes were more evenly distributed between increases and decreases, and the size of the annual percentage change (positive and negative) appeared to be proportional to the initial value. a follow-up of the ecrhs sample approximately years later estimated an incidence rate of rhinitis of . cases per thousand people per year. males had a greater risk in childhood and a lower risk in adulthood of incident rhinitis compared with females. atopic subjects had the highest incidence of rhinitis, at more than cases per thousand people per year. were compared for fathers ( . %) and sons ( . %) and for mothers ( . %) and daughters ( %). later findings from a u.k. study suggested that the prevalence of hay fever had been stable in the latter half of the s. the worldwide prevalence of eczema among -to -year-old children has increased in most regions of the world and has remained stable only in western, northern, and eastern europe. for this younger age group, the prevalence found in the isaac phase three was . %, an increase from the prevalence in phase one of . %. the overall prevalence among -to -year-old children declined to . % in the isaac phase three from . % in the isaac phase one. the regions with the most striking increases in eczema prevalence were asia and latin america. two cross-sectional chinese studies from chongqing showed a statistically significant increase in food allergy prevalence, from . % in to . % in , among young children between the ages of and months. these studies also showed that sensitization to food allergens assessed by positive skin-prick test results had almost doubled, rising from . % to % during the same -year period. other than these studies, there is little evidence on time trends using food challenge tests in general populations, although there is more circumstantial evidence for an increase over time. the prevalence of allergic rhinitis has increased over time in the united states. the nhis estimated a seasonal allergic rhinitis prevalence of %, , an increase of % from the prevalence estimate of . % based on the nhis. the nhis estimated that about . million americans, . million of them younger than age years, have allergic rhinitis. , the survey also showed geographic variation in the prevalence of seasonal allergic rhinitis, with the highest estimated prevalence for the western united states ( . %), followed by the northeast ( . %), south ( . %), and midwest ( . %). studies in other countries have also documented an increase in the prevalence of allergic rhinitis over time. von mutius and colleagues observed a significant increase in hay fever prevalence among schoolchildren from leipzig, germany. the hay fever prevalence rate in the - survey was . %; in the - survey, the prevalence had increased to . %. an italian retrospective study compared data on allergic rhinitis prevalence among italian recruits observed in and from to . the investigators found a significant increase in allergic rhinitis prevalence, from . % in to . % in the - period. results from surveys conducted in and of an adult danish population showed a significant increase of % in the prevalence of allergic rhinitis after adjustment by age and gender. a scottish study observed a threefold increase in the age-adjusted prevalence rate of hay fever between and and in middle-age adults. the hay fever prevalence rates change per year (%) mean prevalence (%) eczema d some genotypes were specifically associated with childhoodonset asthma. gender data from epidemiologic studies consistently reveal male gender to be a risk factor for asthma among young children, whereas studies of adolescents and adults show females to be at greater risk. a review of prospective studies showed that male children were at greater risk for incident asthma or wheeze, and studies of adolescents or adults showed females to be at greater risk. , one hypothesis explaining the excess of asthma seen in boys during childhood is the different airway geometry in boys and girls. boys have smaller airways for a given lung size than girls. lower flow rates were found for boys to years of age, and they have higher airway resistance compared with girls of the same age. this difference in airway anatomy predisposes boys to more wheezing, and they have a higher incidence of lower respiratory tract infections. , martinez and coworkers suggested that reduced lung function was a key determinant of wheezing in boys and girls. in the tucson study, lung function was measured within weeks of birth in healthy infants. the subsequent incidence of wheezing illness over the first years of life was increased in boys with high respiratory resistance and in girls with low functional residual capacity. one hypothesis for females being at higher risk of developing asthma or wheeze during adolescence or adulthood is the smaller relative airway caliber in women compared with men after puberty. epidemiologic studies consistently show an association between atopy and asthma, although the strength of the association varies with the index used and the study population. part of the problem lies in the ambivalent nature of the term asthma.the symptoms of asthma in older adults also can indicate copd, and the differential diagnosis may be difficult even in a clinic. a distinction used to be made between asthma and other wheezy syndromes in children. however, the management is very similar, the distinction has fallen largely into disuse, and use of the term nonatopic asthma has become common for children, whereas it was prviously reserved for a condition associated with eosinophilic inflammation but negative skin test results that predominantly presented in middle age, often among women, and had a relatively poor prognosis. the idea that atopic and airway components of asthma are distinct , has been confirmed by genetic studies thatidentified gene polymorphisms associated with asthma but not obviously related to the regulation of ige or associated immunologic responses. isaac found little variation in the prevalence of nonatopic asthma that could be explained by the local gross income, but prevalence of asthma associated with sensitization became less common in low-income settings. , the distinction is important, because atopic asthma in children apears to have a less benign course than nonatopic disease. burrows and colleagues assessed this association in a random sample selected from tucson, arizona, using skin tests with local antigens as an index of atopic status. in children to years old, atopy was strongly associated with attacks of wheezing and dyspnea, regardless of whether asthma had been diagnosed. later analyses of the tucson population indicated that the total serum ige level was more strongly associated with the prevalence of asthma, an association that was also found in an nhanes analysis (discussed later). another study using self-reported during the -year period from to , hospital admissions for food allergy showed continuing increases of to cases per million people overall and to cases per million children, particularly in the -year-old age group. hospital admissions attributed to "dermatitis due to food" increased in england and wales from cases per million people in to cases per million people in , an increase of almost % per annum. , apart from true changes in the epidemiology of food allergy, alternative explanations for this dramatic increase in health care use for presumed food allergy include changes in the coding behavior of doctors, changes in the awareness and behavior of patients, and changes in the health care system. in the united states, the nhis recorded much smaller increases in parent-reported food allergy, although such reports are usually regarded as unreliable. increasing reports of more specific complaints of peanut allergy have been made for children in the united states and the united kingdom. a genetic component of asthma has long been recognized, based initially on the observation that asthma tends to cluster in families. familial aggregation, twin, genetic linkage, and association studies subsequently provided evidence to support this hypothesis. detailed descriptions of the molecular genetics of asthma and atopic disease are provided in chapter . family aggregation studies compare disease occurrences between family members. disease aggregation between siblings and between parents and children supports a hereditary component, whereas increased aggregation between spouses suggests that environment is more important. however, aggregation among related individuals may represent shared genes or a common household environment. evidence of a hereditary component of asthma has been demonstrated in numerous family-based studies. [ ] [ ] [ ] [ ] population-based studies also have shown an increased prevalence of asthma among first-degree relatives of index cases. [ ] [ ] [ ] [ ] [ ] twin studies compared disease frequency in monozygotic (mz) twins, who share % of their genes, with dizygotic (dz) twins, who share on average % of their genes. this is another method to determine the relative contribution of genetic and environmental factors. a greater occurrence of disease in mz than in dz twins is evidence for a genetic component to the disease because both types of twins are assumed to share environmental factors similarly. significantly higher concordance rates for mz twins have been observed in some small studies. larger studies of twin registries also suggest a significant genetic contribution to asthma. in twin pairs from the swedish twin registry, edfors-lubs found the prevalence of asthma to be . %. the higher concordance of asthma in mz ( . %) over dz ( . %) pairs suggests that genetic factors contribute to asthma. similarly, duffy and associates observed a % concordance in mz twins and % in dz twins in a total of australian pairs. whole-genome association studies have identified specific loci associated with clinical asthma. the genes associated with total ige levels were not strongly associated with asthma, and many related methodologic issues complicate the study of diet and disease. obtaining unbiased exposure estimates is difficult because of recall problems, difficulties in measuring intake, and limited range of variation in the western diet. diet is fundamental to existence and is closely associated with many lifestyle, social, cultural, and environmental factors that may influence the development of disease. although many studies adjust for potential confounders, it has been argued that this is insufficient and that many or all of the reported associations between diet and disease are likely to be confounded by social and behavioral factors acting across the life course. , several reviews on the topic of diet and asthma and allergic disease are available. [ ] [ ] [ ] [ ] [ ] [ ] [ ] observational and randomized studies have directly correlated dietary sodium levels with increased bronchial responsiveness to histamine challenge. [ ] [ ] [ ] one study showed this response occurred in males but not in females. ecologic data from england and wales support these experimental findings; the purchases of table salt correlated with the regions of increased asthma mortality for men and children. other population-based studies, however, have not shown a relationship between urinary sodium levels and methacholine airway responsiveness, [ ] [ ] [ ] although two did show an association with higher levels of potassium excretion. , britton and associates found that increased magnesium intake was associated with a reduced risk of bronchial hyperresponsiveness and wheeze. because of the relationships among sodium, potassium, and magnesium, these investigators suggest the possibility that low levels of dietary magnesium may confound the association of sodium and potassium with bronchial hyperresponsiveness or asthma. a systematic review of the clinical trials of dietary sodium reduction in persons with asthma concluded that dietary sodium reduction does not significantly improve asthma control. dietary sodium reduction was associated with some improvement in lung function in people with exercise-induced asthma, but because extremely large reductions in sodium intake were required, the clinical utility, as distinct from the potential public health relevance of this finding, is likely to be small. a systematic review of the studies correlating asthma and allergic disease in children with dietary intake or status of vitamin a, vitamin c, vitamin e, selenium, zinc, copper, iron, fruits, vegetables, and components of the mediterranean diet identified eligible reports. there were no randomized, controlled trials, and all studies were judged to be at moderate to substantial risk of bias. meta-analyses demonstrated that serum vitamin a was lower in children with asthma compared with controls (odds ratio [or] = . ; % confidence interval [ci], . to . ). the meta-analyses also showed that high maternal dietary vitamin e intake during pregnancy was protective against development of childhood wheezing (or = . ; % ci, . to . ) and that maternal adherence to a mediterranean diet during pregnancy was protective against persistent wheeze (or = . ; % ci, . to . ) and atopy (or = . ; % ci, . to . ) in children. seventeen of fruit and vegetable studies reported beneficial associations with asthma and allergic outcomes. although weak, the available epidemiologic evidence supports dietary intake of vitamin a, vitamin d, vitamin e, zinc, fruits, vegetables, and a mediterranean diet for the prevention of asthma. the fatty acid composition of the diet, particularly the relative amounts of n- (ω- ) and n- (ω- ) polyunsaturated fatty diagnosis of hay fever in a population sample from western pennsylvania showed atopy to be more common in asthmatic than nonasthmatic children. two other studies demonstrated parental atopy and asthma as risk factors for asthma in their children. , the results also demonstrated a complex interaction between these factors and the gender of the child. a study of new zealand children assessed the relationship of total serum ige levels at the age years and asthma, and investigators found that the prevalence of diagnosed asthma was strongly related to the serum ige level (p trend < . ). , asthma was not reported for children with ige levels of less than iu/ ml, whereas % of children with ige levels of iu/ml or higher had asthma. asthma and atopy are closely linked, and the causal nature of the factors seems to be complex and require more investigation. nonetheless, atopy in parents and children does increase the risk of asthma and can be used as an empiric predictor. diet diet, including breastfeeding, food intolerance and sensitivity, and intake levels of specific micronutrients, has been investigated as a potential risk factor for asthma for over decades. in , burney was among the first to propose diet as a potential explanation for the rising frequency of asthma, suggesting the possibility that increasing salt intake might have a role. the rationale for investigating diet as a possible risk factor for asthma and allergic disease is that diet has changed in recent decades and biologically plausible mechanisms exist. many dietary constituents have been investigated for potential involvement in the pathogenesis of asthma and allergic disease, including antioxidants (e.g., vitamin e, vitamin c, carotenoids, flavonoids), polyunsaturated fatty acids, vitamin d, folate, , foods (e.g., fruits, vegetables), metals or trace minerals (e.g., sodium, magnesium, selenium, zinc, copper), and components of the mediterranean diet ( increased ige levels, eosinophilia, methacholine responsiveness, asthma-related hospitalization, exacerbations, use of antiinflammatory medication, and use of oral corticosteroids and with reduced asthma control scores. analogous findings have been reported for adults with asthma. similarly, for children with atopic dermatitis, lower serum -oh-d concentrations have been associated with increased severity of atopic dermatitis. longitudinal cohort studies quantifying vitamin d status before the development of disease are not subject to many of the limitations of cross-sectional studies, such as reverse causation, whereby the vitamin d status of an individual is influenced by the presence of disease (e.g., children with asthma may spend more time indoors). a systematic review and metaanalysis of the longitudinal studies relating maternal vitamin d status during pregnancy to childhood outcomes concluded that high maternal dietary vitamin d intake is associated with a reduced risk of children wheezing up to the age of years (or = . ; % ci, . to . ). however, maternal dietary vitamin d intake during pregnancy is not indicative of total body vitamin d status, because % of vitamin d is derived from cutaneous exposure to ultraviolet light. in contrast to maternal dietary vitamin d intake, high (> nmol/l) maternal serum -oh-d levels in late pregnancy have been associated with an increased likelihood of childhood eczema at age months and asthma at age years. during infancy, increased vitamin d intake has been associated with an increased risk of atopic dermatitis at age years and an increased likelihood of allergic rhinitis and atopic sensitization at the age of years. , in later childhood, an increased serum -oh-d concentration at years of age has been associated with a reduced likelihood of asthma at years of age, and an increased serum -oh-d concentration at years of age has been associated with a reduced likelihood of asthma, rhinoconjunctivitis, and atopic sensitization at years of age. the epidemiologic data support the hypotheses that vitamin d may have beneficial and adverse influences on the development of asthma and allergic disease. ongoing clinical trials are clarifying the potential clinical role of vitamin d in modifying the risk of developing asthma and as an adjunct to asthma and atopic dermatitis therapy. although breastfeeding of infants is recommended because of well-documented benefits for mother and child, the effects of breastfeeding on the subsequent development of atopic dermatitis, wheezing disease, and asthma are not clear. , conceptually, the advantageous consequences of breastfeeding for the infant include acquisition of maternal antibodies and immune-competent cells such as macrophages and leukocytes and protection against early occurrence of lower respiratory tract infections. however, breastfeeding may also be a route of exposure to a variety of immunologically active substances from the mother, such as tobacco smoke, cow's milk, eggs, wheat, maternal ige, and sensitized lymphocytes. many studies have investigated the association between breastfeeding, asthma, wheezing illness, and atopic disease, and they have been subject to several systematic reviews, most of which highlight the limitations and difficulties in conducting and interpreting such studies (e.g., confounding, recruitment bias, reporting bias, reverse causation, variation in breastfeeding patterns, inability to randomize and blind). the systematic reviews have themselves been reviewed in consensus documents, which conclude that the exclusive breastfeeding for to months of acids (pufas) found in fish and vegetable oils, respectively, affects cell functioning. fatty acids appear to have specific roles in inflammatory and immune responses, and changes in fatty acid consumption are a postulated cause of the rising incidence of asthma and other allergic diseases. , conflicting observational data relating n- and n- pufa intake or status during pregnancy, childhood, and adulthood to asthma and allergic disease have been surpassed by intervention trials. a systematic review with meta-analysis evaluated the interventional studies of n- and n- pufa supplementation in the context of primary prevention of asthma and allergic disease. ten reports from six double-blind, randomized, controlled trials were identified. four studies compared n- pufa supplements with placebo, and two studies compared n- pufa supplements with placebo. the meta-analyses failed to identify any consistent or clear benefits associated with n- pufa supplementation during pregnancy or infancy for atopic dermatitis two subsequent trials reported the consequences of n- pufa supplementation during pregnancy. in the first, highdose n- pufa supplementation of pregnant women from weeks' gestation and during breastfeeding reduced the incidence of food allergy and ige-associated atopic dermatitis in children in the first year of life compared with placebo ( % versus % [p < . ] and % versus % [p < . ], respectively). in the second, larger study of pregnant women, high-dose n- pufa supplementation from weeks' gestation until delivery did not reduce the incidence of ige-associated disease or atopic dermatitis during the first year of life compared with placebo (rr = . [ % ci, . to . ] and rr = . [ % ci, . to . ], respectively). there is insufficient evidence to recommend pufa supplementation in any period of life as a means of reducing the burden of asthma and allergic disease. the role of vitamin d in the cause asthma and allergic disease remains unclear. the increase in asthma and allergic disease in developed countries has been attributed to early-life vitamin d supplementation as rickets prophylaxis, and widespread vitamin d deficiency is thought to be a consequence of more time being spent indoors and the active promotion of sun avoidance. cross-sectional, observational studies have reported vitamin d status to be no different or increased in adults with asthma but decreased in children with asthma. , blood levels of -hydroxyvitamin d ( -oh-d) concentrations were found to be lower in adults with atopic dermatitis and allergic rhinitis. , in two studies using nhanes data, blood levels of -oh-d have been no different in adults with evidence of atopic sensitization; however, atopic sensitization was associated with reduced blood -oh-d levels in children and adolescents in one study but not in adolescents in the other. the effect of blood -oh-d levels on current wheeze depended on age and atopic status in another study using nhanes data, with nonatopic individuals and adults years of age or older having a greater risk of wheeze if they had lower -oh-d levels. in children with asthma, lower blood levels of -oh-d have been associated with increased asthma severity, including have reported associations between the prevalence of asthma and obesity, it is not possible to exclude reverse causation, whereby asthma may contribute to obesity through inactivity and use of oral corticosteroids. the most relevant data come from prospective cohort studies that have assessed risk for incident asthma in relation to initial weight or bmi. beuther and sutherland systematically reviewed prospective studies evaluating the association between bmi and incident asthma among adults. meta-analysis of the data from , subjects participating in the seven identified studies demonstrated that being overweight or obese (bmi ≥ ) was associated with an increase in the rate of -year incident asthma (or = . ; % ci, . to . ), with evidence of a dose effect for being overweight (or = . ; % ci, . to . ) or obese (or = . ; % ci, . to . ). there was no difference between sexes. a systematic review of similar literature for children and adolescents concluded that obesity precedes and is associated with the persistence and intensity of asthma symptoms. in observational designs, a potential methodologic concern is that nonspecific respiratory symptoms resulting from cardiorespiratory loading and deconditioning may be misclassified as asthma. careful studies of children and adults suggest that asthma is not inappropriately overdiagnosed in the obese. , observational studies have also reported adverse associations for bmi, obesity and overweight, and atopic dermatitis and atopic sensitization in children and adults. [ ] [ ] [ ] [ ] a retrospective case-control study of children with a mean age of . years confirmed an association between obesity and atopic dermatitis and reported that early-life and prolonged obesity was associated with atopic dermatitis. atopic dermatitis was more prevalent among children who were obese before years of age (or = . ; % ci, . to ) and between and years of age (or = . ; % ci, . to . ). obesity after the age of years was not associated with atopic dermatitis. children who were obese for . to . years (or = . ; % ci, . to . ) and for more than years (or = . ; % ci, . to . ) were more likely to be diagnosed with atopic dermatitis. infants at high risk for atopic disease reduces the likelihood of atopic dermatitis and that breastfeeding beyond to months appears to confer no additional benefit. , the available evidence also suggests that the breastfeeding of infants at low risk for atopic disease does not reduce the incidence of atopic dermatitis. the evidence for a protective effect of breastfeeding against respiratory disease is controversial. although breastfeeding appears to reduce the incidence of virus-associated wheezing episodes in young children (< years), the evidence of an effect on breastfeeding on the development of asthma is inconsistent. systematic reviews suggest that exclusive breastfeeding for to months is associated with a reduced risk of asthma in children to years old, but this beneficial effect is limited to infants at high risk for atopic disease. some systematic reviews have revisited the literature relating breastfeeding to childhood atopic dermatitis, asthma, and wheezing. a systematic review examining the association between exclusive breastfeeding for months or longer and the development of childhood atopic dermatitis identified reports from study populations and concluded that there was no strong evidence that exclusive breastfeeding confers a beneficial effect on the development of childhood atopic dermatitis (summary or = . ; % ci, . to . ), even in children at high familial risk (or = . ; % ci, . to . ). another systematic review clarified the association between breastfeeding and childhood asthma and wheezing after years of age. it examined publications and concluded that breastfeeding for months or longer did not confer any beneficial effect on the incidence of asthma and wheezing illness after the age of years. the summary odds ratio for any breastfeeding and wheezing was . ( % ci, . to . ), and for exclusive breastfeeding and wheezing, it was . ( % ci, . to . ). the prevalence of obesity increased dramatically in many countries, particularly western and other developed countries in the latter decades of the twentieth century. in the united states, for example, the prevalence of overweight and obesity among adults rose sharply across the s, such that most adults are now overweight. the prevalence of childhood overweight is also rising rapidly. the rise in obesity parallels the rise of asthma, and a hypothesis has been advanced that obesity could be a risk factor for asthma. several mechanisms have been postulated for the association, including the mechanical effects of obesity, a higher frequency of gastric esophageal reflux, upregulation of immunologic and inflammatory correlates of obesity, and a shared genetic basis for both conditions. , the association of obesity with asthma has been investigated in children and adults. camargo and colleagues offered one of the first reports in their paper based on the nurses' health study ii. the body mass index (bmi) in was positively and strongly associated with asthma risk over the next few years (fig. - ) . similar studies have addressed obesity and asthma in children. in a cross-sectional study using nhanes iii data, von mutius and colleagues found a positive association between bmi and asthma risk (or = . ; % ci, . to . ) by comparing the highest and lowest quartiles of bmi. in the tucson study, girls becoming overweight or obese between the ages of and years had a sevenfold increased risk for asthma. although many cross-sectional observational studies ≥ . at years. because most children are not hospitalized for lower respiratory tract disease, these results apply only to the more severe infections. a population-based study of children in east boston, massachusetts, however, found that a history of bronchiolitis or croup was a predictor of increased airway responsiveness. in another boston area study, children from a birth cohort with lower respiratory tract infection (i.e., croup, bronchitis, bronchiolitis, or pneumonia) in the first year of life were twice as likely to report two or more episodes of wheeze than children with no lower respiratory tract infection. the tucson children's respiratory study provides relevant data on follow-up from birth to age years. , results from this longitudinal study show that rsv infection was associated with an increased risk of infrequent and frequent wheeze by age years. the relative risk for wheeze after years of age for children with rsv infection compared with children with no rsv infection decreased over time. the relative risk decreased with age from . and . at age years to no risk at age years for infrequent wheeze and frequent wheeze, respectively. support for the idea that severe rsv-associated respiratory disease probably does not contribute to the development of asthma has been provided by a large ( pairs) danish twin registry study that applied genetic variance and direction of causation models to data on rsv-associated hospitalization and the development of asthma. a model in which asthma caused rsv-related hospitalization fit the data significantly better than a model in which rsv-related hospitalization caused asthma, suggesting that rsv infection does not cause asthma but reflects an underlying predisposition to asthma. the role of viruses in the natural history of asthma has been highlighted by several longitudinal cohort studies. the wisconsin childhood origins of asthma (coast) study prospectively evaluated the timing, frequency, severity, and cause of symptomatic viral infection in the first years of life in relation to later wheezing illness in a cohort of neonates at high familial risk for asthma. by using molecular technologies to identify viral infections in nasal lavage samples collected routinely and when symptomatic, this study highlighted the prognostic importance of hrv. having one or more hrvassociated wheezing episodes during the first years of life was more strongly associated with wheezing in the third year (or = . ; % ci, . to . ) than having one or more rsv-associated wheezing episodes during the first years of life (or = . ; % ci, . to . ). first-year wheezing associated with hrv was the strongest predictor for third-year wheeze (or = . ). the pattern of viral respiratory tract infection in the first years was different for children with or without asthma at the age of years (fig. - ) . asthma at years of age was strongly associated with hrv-associated wheeze in the first years of life (or = . ; % ci, . to . ). the frequency of hrv-induced wheezing episodes increased in the first years of life for children diagnosed with asthma by age , whereas for children without asthma, hrv-associated wheezing episodes declined in the first years (see fig. - ) . almost % of children with hrv-associated wheezing episodes in year had been diagnosed with asthma by the age of years, and hrv-associated wheeze was a more robust predictor for subsequent asthma than atopic sensitization to aeroallergens. asthma at years of age was also associated with rsv-associated wheezing episodes in the first years (or = . ; % ci, . to . ). the likelihood of asthma by age years being associated with rsv-induced wheeze in the first years of life was increased these findings are provocative and indicate another potential risk factor for asthma and allergic disease, one that is increasingly prevalent and amenable to intervention. a better understanding of the mechanisms and potential role of intervention in the primary and secondary prevention of disease is needed. respiratory infections are common in the first years of life, and they provoke wheezing in children with or without asthma. less certain is whether viral or other respiratory infections have a direct role in the pathogenesis of asthma or they merely reveal that a child is predisposed to asthma. investigation of the association of viral infection and asthma has been limited by available technology, with culture, serology, and antigen detection having % to % detection rates. the newer molecular technologies have improved the rates of viral detection up to about % and have revealed the importance of previously unknown viruses, such as human rhinovirus c (hrv-c). lower respiratory tract infections in children, which are caused by hrvs, respiratory syncytial virus (rsv), parainfluenza viruses, and other pathogens, are universal in childhood. a community-based study in tecumseh, michigan, estimated that children experience, on average, . lower respiratory tract infections in the first year of life and . such infections between and years of age. another cohort study of respiratory illnesses from birth through months in albuquerque, new mexico, adapted a surveillance system similar to the one used in tecumseh and found comparable incidence rates from through . the incidence of severe episodes of viral respiratory infections was captured in another study using surveillance through a pediatric group practice. this study showed that % of children were affected in the first year of life, that % had annual occurrences by age years, and that % of children to years old experienced annual episodes of infection. follow-up studies of children with a history of hospitalization for respiratory infections suggest that these illnesses may predispose to the development of asthma. in several studies, children with past hospitalizations tended to have abnormal lung function that was indicative of airflow obstruction, including hyperinflation, increased respiratory resistance, and reduced spirometric flow rates. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] in children with past hospitalizations, increased airway reactivity occurred after assessment by exercise, cold air inhalation, methacholine, or histamine inhalation challenge. [ ] [ ] [ ] infants hospitalized with rsv-associated bronchiolitis are more likely to wheeze and develop asthma later in childhood. a study of swedish children found that those who were hospitalized with rsv bronchiolitis in infancy were almost nine times more likely to have physician-diagnosed asthma at age years than those without infection. being hospitalized with rsv bronchiolitis in infancy was an independent risk factor for current asthma and recurring wheezing (or = . ; % ci, . to . ). henderson and colleagues described the relationship of hospitalization for rsv bronchiolitis in infancy and asthma in a population-based birth cohort study of more than children from the united kingdom. hospitalization for rsv bronchiolitis was associated with physician-diagnosed asthma at age years (or = . ; % ci, . to . ) only among nonatopic children. no association was observed for children with atopy type (hrv- ) replicates more readily in the airway epithelial cells of people with asthma, and the airway epithelial cells are more likely to lyse and have greatly impaired interferon-λ (ifn-λ) and ifn-β responses. van der zalm and coworkers reported that increased neonatal airway resistance was related to an increased likelihood of hrv-associated wheeze in the first year of life (or = . ; % ci, . to . ). hrv was originally classified as serotypes hrv-a and hrv-b, but in , a novel hrv designated hrv-c was identified using reverse transcription-polymerase chain reaction (rt-pcr). hrv-c has been implicated in the natural history of wheezing disease and asthma, and it appears to have prognostic importance. in a prospective, population-based study of children younger than years of age who were hospitalized in two u.s. counties with acute respiratory illness or fever, hrv was detected in %, and hrv-c was isolated slightly more than % of them. children from whom hrv-c was isolated were significantly more likely than those with hrv-a or hrv-b to have underlying high-risk conditions such as asthma (or = . ; % ci, . to . ). in australia, hrv serotypes were isolated from % of children to years old who presented to the hospital with acute asthma. hrv-c was isolated from % of the children, and these children had higher asthma severity scores than those infected with hrv-a or hrv-b. in a study of children hospitalized in hong kong, hrvs were isolated from % of children admitted because of acute asthma and from % of control, nonatopic children hospitalized with nonasthma respiratory conditions. hrv-c was isolated from % of the children with acute asthma and % of the controls, and children with hrv-c were more likely to require supplemental oxygen. these studies implicate hrv-c in most episodes of acute asthma requiring hospital attention. hrv-c appears to be more virulent than other hrv serotypes, particularly in children with atopic sensitization. although the major focus has been on viral respiratory tract infection, asymptomatic early-life bacterial airway colonization has also been associated with childhood wheeze and asthma. in the copenhagen prospective study of asthma in childhood, neonates at high familial risk for asthma had their hypopharyngeal regions sampled at month of age, and the children were then followed up to years of age. neonatal colonization of the hypopharyngeal region by streptococcus pneumoniae, haemophilus influenzae, and moraxella catarrhalis (but not staphylococcus aureus) in isolation or in combination was associated with increased likelihood of subsequent wheeze, hospitalization with wheeze, and asthma. hypopharyngeal colonization at year of age was not associated with neonatal colonization or the development of wheeze or asthma. although has been postulated that early-life bacterial colonization induced neutrophilic airway inflammation with consequent wheeze and asthma, it also has been suggested that neonatal airway colonization by these bacteria reflects defective early-life innate immune responses that predispose to asthma. asthma-like symptoms, especially in young children, often are treated with antibiotics, and an association has been observed between the use of these drugs and the risk of asthma. the simultaneously increased use of antibiotics in children and the increasing prevalence of asthma in developed countries has led to the hypothesis (consistent with the hygiene hypothesis) that antibiotic use may contribute to asthma by altering the normal colonization of gut flora in infants and increasing the only for children who had also had hrv-associated wheezing episodes. measurement of lung function in the coast cohort at age years demonstrated that hrv-associated wheezing episodes in the first years of life were associated with reduced lung function: fev of % of predicted for those with hrvassociated wheeze versus % for no hrv-associated wheeze (p < . ). similar differences were found for absolute fev , forced expiratory volume in . second (fev . ), and forced expiratory flow determined over the middle % of a patient's expired volume (fef ). lung function at age was not associated with the frequency of hrv-associated wheeze nor with rsv-associated wheeze. although studies such as coast demonstrate that hrv respiratory infection is prognostically more important than rsv infection for subsequent asthma, whether virus-associated wheezing episodes (particularly hrv) contribute to the pathogenesis of asthma or are merely manifestations of infection in children predisposed to asthma remains an unanswered question. there is evidence supporting the concept that children predisposed to asthma have lung function and airway epithelial abnormalities from very early in life that increase the likelihood of virus-associated wheezing episodes. [ ] [ ] [ ] human rhinovirus cross-sectional studies. in one of the earliest reports, northway and coworkers considered the first possibility-that asthma is a long-term consequence of bronchopulmonary dysplasia (bpd). bpd is a syndrome of chronic lung disease in premature infants who are mechanically ventilated for at least week as a treatment for rds. the clinical diagnosis requires the symptoms of persistent respiratory distress during infancy, dependence on supplemental oxygen, and abnormal chest radiographs. northway and colleagues then studied adolescents and young adults born between and who had bpd in infancy and compared their long-term pulmonary outcomes with those of two control groups. they found that most subjects with a history of bpd in infancy had pulmonary dysfunction. moreover, the increase in airway reactivity was not associated with a more frequent family history of asthma in this sample or with an increased prevalence of atopy. these findings suggest that lung injury resulting from mechanical ventilation of premature infants has a role in the pathogenesis of persistent pulmonary dysfunction that is similar to asthma. bertrand and associates investigated the role of rds in prematurity in the pathogenesis of airway hyperresponsiveness (ahr) in subjects who did not have bpd as infants. the group with a history of rds had evidence of more hyperinflation and airway obstruction compared with controls. however, results from the histamine challenge to determine ahr and familial aggregation of ahr were inconclusive. the incidence of airway reactivity was elevated among cases and controls and among the mothers and siblings of cases and controls. the investigators suggest that the elevated incidence of ahr among mothers of both groups supports the hypothesis that there may be an association between the onset of premature labor and airway reactivity. because no comparison group was established for mothers of term children, however, this assertion cannot be affirmed from the study. some researchers have investigated the effect of very low birth weight (vlbw < g) and bpd on asthma development in birth cohorts. [ ] [ ] [ ] [ ] [ ] [ ] [ ] children with vlbw were followed for years as part of the newborn lung project conducted in wisconsin and iowa. , results at age years did not show a consistent association between asthma and bpd. children with diagnosed bpd and children with radiographically identified bpd had about a threefold and twofold increase, respectively, in the risk of bronchodilator use up to age years, adjusted for birth weight, gestational age, gender, race, and neonatal center. among children with bpd, the prevalence of ever having asthma at age years did not show a difference by the period of birth. however, the prevalence of wheezing in the last year at years of age decreased from % to % over time. as the researchers observed, this finding could have resulted from the introduction of surfactant therapy as a bpd treatment. prematurity as a risk factor for asthma has been explored in cross-sectional studies. [ ] [ ] [ ] [ ] [ ] [ ] a significant association between current asthma prevalence and premature girls was observed in a study of schoolchildren. significantly more premature children had a family history of asthma than did term children, and this association was stronger among children who required mechanical ventilation as premature infants. another german study of schoolchildren did not show an association between former or current asthma and low birth weight (lbw < g) among premature children. however, bronchial hyperresponsiveness was significantly increased in children born at atopic, helper t cell type (th ) immune responses. , in support of this hypothesis, humans exposed to stable and farm environments, which are rich in microbes, show significantly reduced levels of asthma and atopic disease compared with those in other rural or nonrural environments. other studies have shown that the different proportion of aerobic and anaerobic gut flora in children from sweden compared with estonia parallels the difference in atopy incidence between these populations. , animal studies also support the hypothesis. mice given oral antibiotics had altered intestinal flora and impaired helper t cell type (th ) immune responses. epidemiologic studies of asthma and allergic disease in relation to antibiotic use are beset by biases, including reverse causality (i.e., asthma leads to more common prescription of antibiotics) and confounding by indication (i.e. respiratory infections leading to antibiotic use may be implicated in the development of asthma). to illustrate this problem, in a carefully conducted tucson birth cohort study, information on illness, antibiotic use, and physician visits was ascertained on seven occasions in the first months of life and correlated with the development of asthma and allergic disease up to the age of years. a significant association between the number of early-life courses of antibiotics and asthma was reported. the number of physician visits was associated with the number of antibiotic courses and with asthma. however, after adjustment for the number of physician visits, antibiotic use was not associated with asthma, and it was concluded that any association between early-life antibiotic use and asthma was an artifact of the number of physician visits for illness, which was strongly associated with antibiotic use and risk of asthma. two systematic reviews have provided insight into the possible causative association between early-life antibiotic use and asthma and allergic disease. a systematic review of studies that have related antibiotic exposure during pregnancy or in the first year of life with risk of childhood asthma identified relevant studies. antibiotic use in the first year of life was associated with an increased likelihood of childhood asthma (or = . ; % ci, . to . ). stratified analysis indicated that retrospective studies reported the strongest associations (or = . ; % ci, . to . ) compared with database and prospective studies (or = . ; % ci, . to . ) . studies that addressed potential biases by adjusting for respiratory infections reported the weakest associations (or = . ; % ci, . to . ). a second systematic review focusing on longitudinal studies identified studies, and a meta-analysis indicated that antibiotic use was associated with subsequent wheeze or asthma (or = . ; % ci, . to . ). however, after eliminating nine studies with a high risk of bias, the magnitude of the association was reduced (or = . ; % ci, . to . ). both systematic reviews concluded that there might be a weak link between antibiotic use and subsequent asthma and that biases had exaggerated the strength of any association that might exist. premature birth has been associated with the development of symptoms consistent with asthma and other long-term pulmonary sequelae in a number of studies. the cause of the sequelae is uncertain. the pulmonary injury may be acquired during mechanical ventilation of preterm infants with respiratory distress syndrome (rds), from the rds itself, or from some other facet of prematurity. prematurity has been examined as a risk factor for asthma in cohort studies of affected children and in plants (e.g., grain dust, flour, latex, castor bean, green coffee bean), enzymes (e.g., subtilisin from bacillus subtilis, papain, fungal amylase), wood dust or barks (e.g., western red cedar, oak, reactive dyes), drugs (e.g., penicillin, methyldopa), metals (e.g., halogenated platinum salts, cobalt), and others such as oil mists. they have been classified according to possible pathogenetic mechanisms: high-molecular-weight agents that induce specific ige antibodies; low-molecular-weight substances, such as isocyanates, for which underlying mechanisms are largely unknown; and irritant gases, fumes, and chemicals that induce occupational asthma by nonimmunologic mechanisms. more extensive coverage of these agents and the topic is available elsewhere. , other causes of occupational asthma have been identified through clinical reports, epidemiologic investigations, and population studies. jaakkola and colleagues conducted a casecontrol study in finland. risk for asthma was found to be increased for several occupational groups, including some for which occupational asthma had not been previously reported, such as being a male or female waiter. le moual and coworkers explored associations for occupation and occupational exposures with asthma in , participants in a french survey conducted in . several jobs were associated with an increased risk of asthma of about %. a similar analysis was reported for the united states based on the nhanes iii. several studies provide estimates of the overall importance of occupational asthma. kogevinas and colleagues analyzed data from more than , young adults participating in the ecrhs. an estimated . % of asthma was attributed to occupation, with asthma defined by asthma symptoms or use of medication and assessed by questionnaire. when asthma was defined by questionnaire responses and bronchial hyperresponsiveness, the attributable risk estimated for occupation increased to . %. among members of a u.s. health maintenance organization, one third of persons identified as having new or recurrent asthma were classified as having a potential association with work as the basis for asthma. blanc and toren conducted a meta-analysis of studies on occupational asthma from to mid- . the median attributable risk estimate for occupational asthma was % for all studies identified. when the study quality was taken into account and analyses were limited to those of higher quality, the estimate was %. these estimates included new-onset asthma and reactivation of preexisting asthma. outdoor air pollutants can be classified by origin as natural or manmade. among the naturally occurring air pollutants are particulate matter (including bioaerosols), volatile organic compounds, and ozone. for asthma, the key manmade pollutants result from combustion of fossil fuels in cars, power plants, heating devices, and industrial point sources and from emissions of chemicals from manufacturing facilities, storage tanks, and accidental releases. in the united states, air pollutants have been categorized on the basis of their regulation under the clean air act as criteria pollutants (e.g., lead, nitrogen dioxide [no ], sulfur dioxide [so ], particulate matter [pm], ozone [o ], carbon monoxide [co]) and as air toxics, a specified listing of chemicals that includes some irritants relevant to asthma. these pollutants are a concern throughout the world's polluted cities and regions. many cities and smaller towns and term with lbw compared with children born with normal birth weight, with values adjusted for height, gender, and age. a study conducted as part of the ecrhs examined birth characteristics and asthma symptoms in young adults from norway. the researchers observed a significant decrease in asthma symptoms per -g increase in birth weight, adjusted for gestational age, length at birth, parity, maternal age, gender, adult height, hay fever, and current smoking habits. race and socioeconomic status may be determinants of prematurity and asthma. to test the hypothesis that prematurity was a risk factor for asthma independent of race or socioeconomic status, oliveti and colleagues performed a case-control study using a population restricted to african-american children from impoverished inner-city census tracts in cleveland, ohio. their findings confirmed previous findings with regard to prematurity and lbw. asthmatic children had significantly lower birth weights and gestational ages than nonasthmatic children and were more likely to have required positive-pressure ventilation (ppv) after birth. the risk of asthma was increased more than three times for children receiving ppv after birth. however, the increased risk of asthma due to lbw and prematurity was not significant when maternal history of asthma, bronchiolitis, lack of prenatal care, low maternal weight gain, and ppv were considered simultaneously. this suggests that lung injury and perhaps mechanical ventilation lead to an asthma-like syndrome, rather than lbw and prematurity directly. researchers have examined the lung function of preterm children over time. koumbourlis and associates followed preterm children with chronic lung disease, including bpd, from to years of age. the investigators observed improvements in the lung volumes of these patients throughout childhood and into adolescence, and these improvements were experienced by all children, regardless of the severity of the neonatal chronic lung disease. if patients had airway obstruction, it was primarily localized to the smaller airways, associated with ahr, and relatively fixed over time. two systematic reviews have investigated the association between prematurity and childhood asthma and wheezing outcomes. patelarou and colleagues identified nine studies that had reported on the association between adverse birth outcomes (e.g., premature, lbw, vlbw, fetal growth retardation) and early ( to years) childhood wheeze. they concluded that adverse birth outcomes were associated with wheezing in early life. similarly, a systematic review that identified studies reported that preterm (< weeks' gestation) was associated with an increased likelihood of childhood asthma (or = . ; % ci, . to . ). these results suggest that premature infants with or without neonatal respiratory disease may be at higher risk for asthma or a syndrome similar to asthma than term infants. however, the mechanistic pathways involved and the potential interactions with other asthma risk factors, such as viral respiratory infections and susceptibility genes, remain uncertain. occupational asthma is defined as variable airflow limitation or bronchial hyperresponsiveness due to exposure to a specific agent or conditions in a particular occupational setting but not to stimuli encountered outside the workplace. several hundred agents have been identified as causes of occupational asthma. , they include animal allergens (e.g., urine, dander), for children from east germany, where pollution originated from burning brown coal and industrial emissions. however, living in west germany was not an independent risk factor for asthma after adjustment for sensitivity to pollen, hdms, and cat allergens. another german study conducted from through obtained similar results. current asthma prevalence for children from munich was . %, compared with the prevalence for their counterparts from dresden of . %. significant differences in physician-diagnosed asthma prevalence were observed by comparing children in munich ( . %) and those in dresden, former east germany ( . %). a study enrolling children to years of age who were living in hong kong compared physician-diagnosed asthma prevalence in a high-pollution district and a low-pollution district. the researchers found that asthma prevalence was almost doubled in the high-pollution area compared with the low-pollution area. some studies have investigated the possible role of specific air pollutants in the development of asthma. in a cross-sectional study that was conducted as part of the isaac phase two and enrolled the same german children from dresden, an increase in estimated traffic-related exposure to benzene was associated with an increased prevalence in physician-diagnosed asthma after adjusting for potential confounders. however, this association reached statistical significance only when the home and school addresses used as the exposure indicators were combined. the prevalence of asthma was not associated with concentrations of so , no , and co. an increase in the exposure to air pollutants (except ozone) was associated with an increased prevalence of physician-diagnosed asthma in nonatopic children ( to years and to years old). this relationship was not observed in atopic children. another cross-sectional study evaluating the effects of general air pollution was conducted among , high school students in taiwan as part of the isaac. the researchers investigated the role of long-term exposure (i.e., annual average concentration) to air pollution and the prevalence of asthma. long-term exposure to total suspended particles, no , co, ozone, and airborne dust was associated with increased prevalence of asthma after adjusting for exercise, smoking, alcohol consumption, incense use, and environmental tobacco exposure. a similar study of , middle school students living in counties and cities in taiwan found a positive association between physician-diagnosed asthma prevalence and exposure to co and nitrogen oxides (no x ) when adjusted for age, history of atopic eczema, and parental education. baldi and coworkers reanalyzed data from a survey of children and , adults from seven french towns between and . they estimated a significant increase (or = . ; % ci, . to . ) in asthma prevalence per µg/m in the so -year-period annual mean after adjusting for age, education, and smoking status. the association remained significant when they restricted the analysis to adults reporting their first attack after moving to the study areas. they did not observe this relationship for children. these cross-sectional studies address the prevalence of asthma, which reflects the incidence and duration of the disease. if air pollution increases the duration of asthma, the prevalence would be increased, even without an effect on incidence. the clearest evidence of a causal association between outdoor air pollution and childhood asthma comes from cohort studies. villages in the developing world have the problem of smoke from biomass fuel use for indoor cooking and heating that is emitted outdoors. although it is accepted that exposure to outdoor air pollution can exacerbate existing asthma, - the role of outdoor air pollution in the development of childhood asthma is less well established. however, there is increasing evidence, especially from studies with a focus on exposure related to traffic within urban areas, that implicates outdoor air pollution in the development of childhood asthma [ ] [ ] [ ] and lung function. the outbreaks of acute asthma in barcelona illustrate the consequences of exposure to an airborne contaminant and the need to investigate asthma epidemics. during the s, a remarkable series of epidemics of asthma occurred in barcelona, a port city. careful analysis of one outbreak showed spatial clustering near the harbor, and an epidemiologic investigation showed a very strong association between unloading of soybeans at the harbor and occurrence of the epidemics. an antigen was identified in the soybeans that proved to be responsible for the outbreaks. the outbreaks were traced to releases of dust at a particular silo, and control measures were enacted. subsequently, a review of the historical record showed that there had been similar outbreaks of soybean asthma in new orleans. a large body of experimental and observational evidence links outdoor air pollution to exacerbation of asthma. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] compilations of the evidence can be found in the criteria documents prepared by the u.s. environmental protection agency (epa) for particulate matter and ozone. , human experimental studies have provided some insights, showing for example, that the oxidant pollutants nitrogen dioxide and ozone may enhance the effects of allergens, possibly by increasing the permeability of airways. , epidemiologic data, primarily coming from studies of panels of persons with asthma or of medical morbidity, have shown that the adverse effects of air pollution on asthma are relevant clinically and are significant from a public health perspective. there is uncertainty about the relative effects of specific pollutants compared with the overall toxicity of the air pollution mixture. gent and colleagues investigated the effect of exposure to ozone and particulate matter of . µm in diameter (pm . ) in a u.s. cohort study of asthmatic children. among children using maintenance medication, the level of ozone, but not pm . , was significantly associated with worsening of respiratory symptoms and an increase in rescue medication use. significant associations were not found for children not using maintenance medication. these findings suggest that children with asthma using maintenance medication are especially vulnerable to ozone, even after adjusting for exposure to pm . and at air pollution levels below the epa air quality standards. various lines of epidemiologic evidence continue to indicate a potential role of air pollution in the cause of asthma. crosssectional studies have investigated asthma prevalence and air pollution. after the unification of east and west germany, studies were conducted to compare respiratory diseases among children who had a relatively homogenous genetic background but had experienced exposures to air pollution at very different concentrations. [ ] [ ] [ ] [ ] in a study conducted between and , children to years old from munich (west) had a higher prevalence of physician-diagnosed asthma than those from leipzig and halle (east). current asthma prevalence among children living in west germany, an area with a greater amount of heavy road traffic, was . %, compared with . % also raised. the disparity between cross-sectional and prospective studies suggests that although the incidence of asthma among those living close to traffic is increased, it is not evident at a population level because of the small effect size and the lack of variation in the distance between home and traffic. cohort studies published since the comeap are consistent with its findings, but they also highlight a possible early-life effect and the importance of exposure while at school. the dutch prevention and incidence of asthma and mite allergy (piama) birth cohort study related symptom data prospectively collected annually from children up to the age of years to land-use regression estimates of individual no , pm . , and soot exposures at their birth addresses. pm . was associated with an increased annual incidence of asthma (or . ; % ci, . to . ), prevalence of asthma (or = . ; % ci, . to . ), and asthma symptoms (or = . ; % ci, . to . ). the associations between outcomes and no and soot exposures were similar, but there was a high correlation (r > . ) for pm . , no , and soot exposures. only % of the cohort were still living at the birth address at age years, and the associations between pollutants and outcomes were evident only in those who had not moved house; for the children who had moved from the birth addresses, the only significant association was between pm . and the prevalence of wheezing symptoms (or = . ; % ci, . to . ). the southern californian health study evaluated symptom-free children recruited in kindergarten or the first grade (≤ years old) from communities, each with continuous ambient ozone, no , pm . , and pm measurement. the incidence of asthma in the subsequent years was determined by annual questionnaires and correlated with individualized estimates of traffic-related pollution at home and at school. the incidence of asthma was increased by nonfreeway traffic-related pollution at home (hazard ratio [hr] = . ; % ci, . to . ) and at school (hr = . ; % ci, . to . ) . although the balance of evidence suggests an association between outdoor air pollution and the development of asthma in some individuals who live near busy roads, there does not appear to be an association between air pollution and the development of asthma at the population level. moreover, the welldocumented increase in asthma prevalence in the latter decades of the twentieth century cannot be readily explained by changes in levels of the major combustion pollutants. the emerging association between traffic-related emissions and asthma requires further investigation. in the home and other indoor environments, children and adults inhale diverse pollutants that may be associated with the risk for asthma. , they include combustion-source emissions from cooking stoves and ovens, space heaters fueled by gas or kerosene, wood-burning stoves or fireplaces, and tobacco smoking; volatile and semivolatile organic compounds released from household products, furnishings, and other sources; and allergens from insects, molds, mites, rodents, and pets. , many of these pollutants can be present in higher concentrations indoors than outdoors, providing a rationale for studies that have examined indoor pollutants as factors that may cause or exacerbate asthma. for example, in a prospective cohort study of inner-city u.s. children with asthma, indoor no and pm were associated with asthma symptoms. the associations were independent of each other and of outdoor the traffic-related air pollution and childhood asthma (trapca) study is a birth cohort study of children from the netherlands, germany, and sweden that is funded by the european union. preliminary results from the german children followed for their first years of life showed a % ( % ci, . to . ) increase in the risk of asthmatic, spastic, or obstructive bronchitis for those living close to major roads (< m) compared with children farther away. a cohort study of almost children between the ages of and years, who lived in nine communities surveyed in the california children's health study and four other communities, was started in to evaluate characteristics that might increase children's susceptibilities to the effects of traffic-related pollution. preliminary results showed that living within m of a major road was associated with an increased risk of physician-diagnosed asthma (or . ; % ci, . to . ), prevalent asthma (or = . ; % ci, . to . ), and wheeze (or = . ; % ci, . to . ). among long-term residents (i.e., living in the same home since the child was years old or younger) with no parental history of asthma, an increased risk of physician-diagnosed asthma (or = . ; % ci, . to . ), prevalent asthma (or = . ; % ci, . to . ), and wheeze (or = . ; % ci, . to . ) was associated with living within m of a major road. increased risk was not associated with the exposure for children with a parental history of asthma and for short-term residents. the adventist health study on smog (ahsmog) is a prospective cohort study that enrolled more than nonsmoking adults ( to years old) living in california in . in the first years of follow-up, abbey and colleagues examined incident asthma cases in relation to pm and found a % increased risk of asthma for a hr/yr exposure to concentrations of pm that exceeded µg/m . a later report on the ahsmog participants used the - -hour mean ozone concentration as the exposure and found that the risk of developing asthma doubled per parts per billion increase for males but not in females after adjusting for age, education, respiratory infection before age years, and smoking status. a systematic review commissioned by the u.k. committee on the medical effects of air pollution (comeap) was established to investigate whether outdoor air pollution causes asthma. this review identified cross-sectional studies relating asthma prevalence in more than four cities to quantitative pollution measures; the number of cities ranged from to and covered europe, north america, and asia. a metaanalysis revealed no significant associations between no , pm , or so and period prevalence of wheeze and lifetime prevalence of asthma. the review also identified studies of birth cohorts and studies of cohorts recruited during child or adulthood. in these studies, exposures were individualized by modeling, usually to the individual's home address. in contrast to the cross-sectional studies, meta-analysis revealed associations between no and the incidence of asthma (or = . ; % ci, . to . ; studies) and between pm . and the incidence of asthma (or = . ; % ci, . to . ; studies). the comeap systematic review concluded that the evidence from the cohort studies is consistent with a significant increase in the incidence of asthma associated with no and pm from traffic sources. the possibilities of air pollution aggravating existing subclinical asthma and residual confounding by factors associated with asthma and residential proximity to traffic were assessed early indoor allergen exposure and physician-diagnosed asthma or wheeze and did not find an association. they concluded that their results did not support the hypothesis that allergen exposure causes asthma. prospective cohort studies have studied the relationship between exposure to mold and the risk of asthma. a study of finnish children to years old used parents' reports of mold and dampness as a surrogate for exposure to aeroallergens in the home. after years of follow-up, exposure to mold was found to be an independent risk factor for asthma among finnish children. the incidence of physician-diagnosed asthma was double for children in homes with reported mold odor compared with those that did not. jaakkola and jaakkola reviewed the literature on indoor molds and asthma, and they concluded that exposure to molds at home increases the risk of asthma among adults and that exposure to molds at work increases the risk of wheezing. they observed that exposure to indoor molds increases the severity of asthma and that removing the source relieves or eliminates symptoms and signs of asthma. sensitization to mold has been linked to the presence, persistence, and severity of asthma. , a review of housing interventions designed to improve outcomes concluded that asthma symptoms could be reduced by removing moldy items and eliminating leaks and other moisture sources in homes. intervention studies with avoidance of aeroallergens and food allergens have not consistently found a reduction of asthma risk among children. the canadian childhood asthma primary prevention study included high-risk children who were randomized to intervention (i.e., avoidance of hdm by use of mattress covers and acaricides, pets, and passive smoking and encouragement of breastfeeding with delayed introduction of solid foods) or to control groups before birth. for children at years of age, the prevalence of physician-diagnosed asthma was significantly lower for the intervention group ( %) than for the control group ( %). another intervention study of a birth cohort of high-risk children living on the isle of wight assessed asthma (i.e., wheeze and bronchial hyperresponsiveness) prevalence at age years and found that the asthma risk was ninefold higher for the control group than the intervention group. intervention included breastfeeding by a mother on a low-allergen diet or giving a hydrolyzed formula and reducing hdm exposure with an acaricide and mattress covers. however, the australian childhood asthma prevention study, which included highrisk children randomized to an hdm avoidance intervention group or control group, did not find a significant reduction in the prevalence of current asthma at age years for the intervention group compared with the control group. a systematic review and meta-analysis of prospective birth cohort studies evaluating the effects of allergen (i.e., hdm or dietary) avoidance during pregnancy concluded that early-life allergen avoidance in isolation does not reduce the likelihood of asthma in children at age years (or = . ; % ci, . to . ). however, multifaceted antenatal intervention that combines breastfeeding with allergen avoidance and maternal smoking cessation does reduce the likelihood of asthma in children at age years (or = . ; % ci, . to . ). exposure to tobacco smoke has serious adverse effects on the respiratory tract. perhaps because of the sensitivity of the concentrations of the pollutant. a full examination of this literature is beyond the scope of this chapter, but reviews of indoor air pollution are available. whether these exposures by themselves, in the absence of underlying genetic susceptibility, can cause asthma is uncertain. however, mounting evidence indicates that maternal smoking is associated with an increased risk for asthma in offspring and later exacerbations of asthma (see "involuntary or passive smoking") and that levels of allergen exposure are associated with the incidence of asthma and wheezing. however, there have been only limited investigations of indoor air pollution and the incidence of asthma linked to risk factors other than passive exposure to tobacco smoke. an institute of medicine committee reviewed the evidence on indoor air pollution and childhood asthma and derived conclusions regarding causation and exacerbation. this topic also has been reviewed elsewhere. , several investigations have addressed the prevalence of asthma and exposure to nitrogen oxides from cooking stoves. homes with natural gas-fueled or propane-fueled cooking stoves tend to have no levels substantially above those of homes with electric stoves. some investigations indicate a general increased risk of respiratory symptoms, including wheezing, in households with gas stoves, but the data are inconsistent and not indicative of increased asthma incidence caused by nitrogen oxides. , the myriad exposures to volatile and semivolatile organic compounds that can occur in homes and other locales have been investigated as risk factors for childhood asthma. although many cross-sectional studies report an association between volatile organic compound exposure and asthma in children , and adults, , these studies cannot establish causality and are beset by the problem of reverse causality, whereby parents modify their houses (e.g., laminate flooring) as a consequence of their children developing asthma. cohort studies suggest that maternal volatile organic compound exposure during pregnancy can influence the development of childhood allergic disease. this is an area of ongoing research because of the potential for intervention by behavioral modification and low volatile organic compound technology. studies of indoor allergens have largely focused on the status of children with asthma in relation to levels of allergen rather than considering the levels of allergens as predictors of asthma. a prospective cohort study conducted in the united kingdom found levels of hdms in the home to predict later development of asthma, and children with higher levels of hdm antigen in their homes tended to wheeze at a younger age. the german multicentre allergy study followed children from birth to years of age and found that sensitization to perennial allergens such as hdms, cat hair, and dog hair that developed before years of age was associated with a loss of lung function at school age. a u.s. study of children indicated that exposure to two or more dogs or cats in the first year of life might reduce subsequent allergic sensitization risk to multiple allergens during childhood. not all studies support the conclusion that allergen exposure causes asthma. a british cohort study did not find a significant association between levels of hdm exposure and sensitization or wheeze. results from a german birth cohort of children followed until age years showed a strong association between sensitivity to hdm allergens or cat allergens and wheezing from years of age. however, the investigators also during pregnancy has also been associated with increased in vitro cord blood mononuclear cell proliferative and cytokine responses after stimulation with allergens. , there is extensive literature on the relationship between passive smoking and childhood wheeze and asthma. a systematic review identified relevant prospective cohort studies. exposure to maternal (prenatal and postnatal), paternal, and household sources of cigarette smoke was associated with an increased likelihood of children wheezing up to the age of years. the strongest associations for childhood wheeze were for postnatal exposure to maternal cigarette smoking: wheeze at years or younger (or = . ; % ci, . to . ), to years (or = . ; % ci, . to . ), and to years (or = . ; % ci, . to . ). the associations between exposure to maternal, paternal and household cigarette smoke and childhood asthma were not as strong as for wheeze, but they were most noticeable for maternal smoking during pregnancy: childhood asthma at years or younger (or = . ; % ci, . to . ) and to years (or = . ; % ci, . to . ). paternal smoking was associated with an increase in childhood asthma between and years, and household smoking was associated with an increase in childhood asthma after the age of years. the children's health study based in california reported a transgenerational association, suggesting that exposure to cigarette smoke in utero may have epigenetic effects. in a nested case-control study of children at years of age ( with asthma and controls), the likelihood of childhood asthma was increased if the mother (or = . ; % ci, . to . ) or the maternal grandmother (or = . ; % ci, . to . ) smoked during pregnancy. if the mother and grandmother smoked during pregnancy, the likelihood of childhood asthma was increased further (or = . ; % ci, . to . ). although allergic rhinitis is common, few epidemiologic studies have focused on this disease. the most frequently cited risk factors include increasing age, atopy, and high socioeconomic status. parental history is positively associated with the development of allergic rhinitis in offspring. in the tucson birth cohort study, a maternal history of physician-diagnosed allergy was significantly associated with a diagnosis of rhinitis by age years (or = . ; % ci, . to . ). perinatal and infant risk factors have been examined. for example, younger gestational age at birth has been associated with a decreased risk of allergic rhinitis. , some researchers have postulated that early-life exposures to microbes may modulate risk of allergic rhinitis, and this hypothesis has been supported by the observations that birth by cesarean section is a risk factor for allergic rhinitis, as is reduced diversity of the intestinal microbiota in infancy. other risk factors under investigation include genetics, early-life exposure to infections, acetaminophen use, oral contraceptive use, and indoor and outdoor air pollution exposure. risk factors for eczema include gender, race or ethnicity, family history, early-life antibiotic use, environmental exposures, and dietary factors, including breastfeeding, timing of the introduction of solids, and inclusion of probiotics. family history of asthmatic lung to cigarette smoke, young smokers tend to have somewhat greater lung function and less underlying airway responsiveness than nonsmokers-a phenomenon sometimes referred to as the healthy smoker effect. nonetheless, substantial data show that active smoking increases nonspecific responsiveness of the airways, perhaps by inducing inflammation or by narrowing baseline airway caliber in older people. smokers also tend to report wheezing more frequently than nonsmokers, and wheezing tends to decline after cessation of smoking. increased airway responsiveness in active smokers also tends to abate after smoking cessation. , a systematic review of studies exploring the temporal association between active smoking and asthma reported that most studies indicated that people who smoked were at increased risk for asthma. these studies evaluated diverse sample populations and used different methods, and the review highlighted the potential for residual confounding by health behaviors (e.g., physical exercise). the review concluded that although active smoking might be a risk factor for asthma, the evidence was insufficient to conclusively state whether smoking was a causal or proxy risk factor for asthma. the nonsmoking child is exposed to second-hand smoke, a name given to the mixture of sidestream smoke released by a burning cigarette and the mainstream smoke exhaled into the air by the smoker. this mixture has also been called environmental tobacco smoke. smoking adds respirable particles and irritant gases to indoor air, and it represents one of the major sources of fine particles in the air of u.s. homes. exposure of children to particles and gases in tobacco smoke has been documented by measuring personal exposures and using biomarkers that indicate the levels of tobacco smoke components absorbed into the body. cotinine, a major metabolite of nicotine, has been extensively investigated in children in relation to parental smoking. compared with children living in households in which there is no smoking, children living with smokers tend to have substantially higher cotinine levels. , in the past, exposure to second-hand smoke was widespread. almost all participants, including nonsmokers, in the - nhanes iii had detectable serum cotinine levels. ten years later, nhanes iv showed a dramatic reduction in cotinine levels, a trend that has continued. exposure to second-hand smoke contributes to both the causation and the exacerbation of asthma. first, passive smoking may increase the risk of more severe lower respiratory tract infections during the early years of life. second, the direct toxic effects of second-hand smoke may induce and maintain the heightened nonspecific responsiveness of airways found in asthmatic children. third, many children have secondhand smoke exposure during gestation and after birth. substantial evidence suggests that in utero exposure to tobacco smoke components affects fetal airway and immune system development. young and associates assessed nonspecific airway responsiveness using a histamine challenge for normal infants at a mean age of . weeks. even at this young age, parental smoking and a family history of asthma were associated with an increased level of airway responsiveness. in a similar prospective investigation, hanrahan and colleagues found that children whose mothers smoked during pregnancy had a lower level of airway function soon after birth. maternal smoking later epidemiologic studies provided a deeper understanding of the physiologic consequences of having childhood asthma and indicated that the lungs of these children might already have heightened airway responsiveness at birth. birth cohort studies that include indices of ventilatory function and airway responsiveness during the first weeks of life indicate that infants at risk for asthma because of a parental history of asthma and atopy already have heightened responsiveness to a challenge. the tucson study clarified the early natural history of wheezing. , martinez and colleagues described the natural history of wheezing beginning before years of age and found that some children had only transient early wheezing. children who continued to wheeze up to years of age were more likely to have mothers with a history of asthma and to have an elevated serum ige levels, suggesting that the early wheezing represented asthma. children whose wheezing did not persist had diminished airway function in early life but did not tend to have mothers with asthma or elevated ige levels. the pattern of persistence of wheezing during childhood and into adulthood was similar in a smaller cohort study of children in england, who were followed from birth to age years. in this highrisk cohort, early wheezing was not likely to persist, but wheezing at years of age did tend to persist. the results of these studies imply that clinicians should be cautious in labeling all early childhood illnesses with wheezing as asthma, because some children are predisposed to wheeze with respiratory infections because of reduced airway function. population-based groups of children have been followed over time in prospective cohort studies (table - ) . because most of these studies have drawn participants from defined populations, there is less potential for bias by the selection process, and the children with asthma are more likely to be representative. information collected from childhood to early adulthood is available from several investigations, including two particularly large studies involving lengthy follow-up: the cohort study in australia and the birth cohort study in the united kingdom. , findings of a number of smaller studies have been similar (see table - ). one of the first studies using a birth cohort design was conducted in australia, initially by williams and mcnicol. , [ ] [ ] [ ] on enrollment in , the children were years of age, and after years of follow-up, they were years old. [ ] [ ] [ ] wheezing tended to track over time, but % were no longer wheezing at years of age, and only % had wheezing at least weekly. those with more severe wheezing at age years tended to have a lower level of lung function tested by spirometry and to have a higher degree of airway responsiveness to a methacholine challenge. over time, some improved, but an approximately equal proportion worsened. at age years, % of the group with wheezy bronchitis at baseline was free of wheeze, and only % of this group had persistent asthma. symptoms continued in % of the original asthma group and in % of the severe asthma group. almost one half of the severe asthma group continued to have persistent asthma at age years. those with severe asthma had suffered a loss in lung function by years of age, but this loss did not progress in adulthood. children with milder symptoms did not have a significant loss of lung function. in another large, long-term study, members of the birth cohort in the united kingdom were followed up to age years. , , parents were interviewed when the participants eczema has been identified as a risk factor for eczema in several studies, pointing to genetic determinants of eczema. loss-offunction mutations in the filaggrin gene (flg), which encodes a protein critical to skin barrier function, have been directly linked to eczema, and approximately % of people heterozygous for these mutations develop eczema. black and asian race or ethnicity is a risk factor, along with male gender, , although isaac phase three found that worldwide, boys were less likely to have eczema than girls. earlylife exposure to endotoxin appears to protect against the development of eczema, as reported in several studies. , dietary factors, including breastfeeding, infant formulas, timing of solid food introduction, and supplementation with probiotics, have been studied. neither breastfeeding nor timing of solid food introduction has been associated with protection against eczema. [ ] [ ] [ ] [ ] [ ] [ ] evidence suggests that hydrolyzed infant formulas and supplementation with probiotics may afford some protection against eczema, , but study results are mixed, and infection by the probiotic organism has been reported in infants receiving probiotic supplementation. established risk factors for food allergy include male gender for children, eczema, and an atopic family history. [ ] [ ] [ ] other possible risk factors are diet and feeding practices during early childhood. controversy exists about whether early allergen introduction or allergen avoidance may predispose to the development of food allergy. the natural history of asthma is a concern for affected children, their parents, the clinicians providing care, and researchers. parents ask whether the child will outgrow asthma, and clinicians should be able to answer this question. researchers have studied the natural history of asthma and searched for factors that determine prognosis. during adulthood, the former asthmatic child may be exposed to environmental agents, including cigarette smoke, which may adversely affect respiratory health. childhood asthma has been postulated to increase the likely adverse effects of these exposures and other long-term consequences, such as persistent physiologic impairment from airway remodeling. , initial information on the natural history of childhood asthma largely came from cohort studies of children attending general practices or clinics. , these studies, some dating to the s, were a principal source of data on the natural history of asthma until population-based investigations were implemented beginning in the s. these early studies provided evidence of waning of clinical symptoms over time in a substantial proportion of children with asthma. however, most children tended to remain symptomatic. interpretation of these data is constrained by differences between past and current therapeutic approaches, possible lack of representativeness of children receiving care at a particular clinical facility, and by diversity of the research methods. these studies drew the participants from general practices and clinics, and presumably, more severe asthma was represented. nevertheless, they provide evidence that the prognosis is favorable for some children with asthma, even in an era antedating contemporary therapeutic approaches. bronchial challenge testing, and allergy testing. of the participants with complete data for the follow-up period, . % had persistent wheezing into adulthood, and only . % never reported wheezing. the remainder had various patterns of intermittent wheezing. predictors of persistent wheezing included sensitization to hdms, female sex, and smoking at age years. pulmonary function was reduced in those with persistent wheezing. evaluation of the natural history of asthma in adults is complicated by the occurrence of copd and the potential difficulty of separating copd from asthma. in adults, asthma includes disease originating in childhood and following its natural course into adulthood and asthma developing during the adult years. these natural histories have not been carefully delineated, although the lengthier studies of childhood asthma can provide information on its course into adulthood. there is less information on asthma in adulthood that is comparable to that on childhood asthma, such as the longitudinal picture of symptoms and clinical status. however, the effect of having asthma on the decline of lung function has been assessed, and there is limited information on the development of irreversible airflow obstruction in persons with asthma (table - ). the evidence on asthma and change in lung function over time is inconsistent with some studies showing were , , and years of age, and the participants themselves were interviewed at age and years. asthma tended to remit over time; of the children with a report of asthma or wheezy bronchitis before years of age, only % had wheezing in the last year at age years, although this figure increased to % at age years. lung function was evaluated in a sample of of the participants with a history of asthma or wheezy bronchitis and controls. for those not reporting wheezing at age years, lung function was only slightly reduced compared with controls. for those with wheezing, fev was reduced by approximately % compared with controls. similar results were found in a follow-up study of dutch individuals. subjects were extensively tested as children years earlier and reexamined as adults. the data revealed that % of persons were no longer considered asthmatic, % had an fev greater than % of predicted, % were no longer bronchial hyperresponsive, and % did not report asthmatic symptoms. results of these studies support the hypothesis that early intervention in mild asthma may lead to improved outcomes. in a longitudinal, population-based, cohort study carried out in dunedin, new zealand, children were enrolled, and a substantial proportion was followed to age years with repeated assessment by questionnaires, lung function testing, in the copd group and a -ml loss in the intermediate group. the balance of the evidence indicates that a diagnosis of asthma is associated with an increased rate of fev decline (see table - ). perhaps reflecting this excess decline, many elderly persons with asthma have fixed airflow obstruction. there are few studies on the clinical course of asthma in adults (table - ) , and as airway obstruction becomes fixed with advancing age, separating asthma from copd becomes increasingly difficult. in the study by schachter and coworkers, of the male participants age years or older with asthma, % improved and only % worsened during follow-up. among female participants, % improved and none worsened during follow-up. bronniman and burrows followed asthmatics, who were drawn from the general population sample in tucson, arizona, of persons, over a -year period. participants were classified as in remission if they had active disease at baseline and on follow-up denied medication use, asthma attacks, and frequent attacks of shortness of breath with wheezing during the preceding year. after years of follow-up, % were in remission, with the highest rate found among those between and years of age at enrollment ( %) and the lowest rate found for those between and years of age ( %). remission was more common in those with less frequent wheezing, less frequent asthma attacks, and less frequent attacks of shortness of breath with wheezing. remission was significantly less likely increased decline in persons with asthma compared with controls and others showing no difference between asthmatics and controls. peat and woolcock followed persons with asthma, who were to years old on enrollment, and control participants from busselton, australia. the asthmatic individuals had lower lung function values at enrollment and the fev declined at ml/yr more in the persons with asthma compared with the controls. schachter and colleagues followed the lung function of persons with asthma and with wheezing. over a -year interval, there was a similar excess loss of fev in the persons with asthma. ulrik and lange followed subjects over a -year period and found that asthmatic subjects had lower baseline lung function values and an excess annual decline in fev compared with nonasthmatics; the excess annual decline was ml in asthmatic men and ml in asthmatic women. some individuals with asthma appear to eventually develop irreversible airflow obstruction, which has been related to duration and severity of asthma. , a continuing effect of asthma was found when follow-up was extended to years. other studies have not shown increased loss of function associated with having a diagnosis of asthma. burrows and colleagues examined the course of asthma over years in asthmatics from the general population and compared them with two other groups: copd subjects and subjects who did not fit clearly into either group. the asthmatic subjects had a ml/yr decline in fev , compared with a -ml decline years. this was a highly selected group with many comorbidities, which probably influenced the eventual outcome. unfortunately, little is known about the outcome of elderly asthmatics that are not as ill. panhuysen and colleagues followed persons with asthma over years. the participants had been comprehensively evaluated in an asthma clinic in the netherlands between and at the ages of to years (mean, years). on retesting, % no longer showed bronchial hyperresponsiveness on histamine challenge, and based on a lack of bronchial hyperresponsiveness, symptoms, and lung function level, % were considered to no longer have asthma. settipane and colleagues followed a group of college students over years. half of those with asthma on follow-up reported the disease as inactive, although about % of the new cases occurred during follow-up. in those with chronic productive cough or a coexisting diagnosis of chronic bronchitis or emphysema. a normal level of percent predicted fev at baseline was the most powerful predictor of remission. persons to years old with active symptoms had only a % remission rate over years. broder and colleagues reported similar findings, with a remission rate of . % for patients between and years of age and % in those years of age or older. 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of different forms of chronic airways obstruction in a sample from the general population a prospective study of the natural history of asthma. remission and relapse rates epidemiology of asthma and allergic rhinitis in a total community asthma in the elderly. a comparison between patients with recently acquired and long-standing disease natural history of asthma: a -year followup of college students incidence and remission of asthma in schoolchildren: report from the obstructive lung disease in northern sweden studies a prospective study of asthma incidence and its predictors: the rhine study onset and remission of allergic rhinitis and asthma and the relationship with atopic sensitization and smoking incidence of asthma and its determinants among adults in spain incidence of asthma and mortality in a cohort of young adults: a -year prospective study environmental tobacco smoke exposure and nocturnal symptoms among inner-city children with asthma incidence of asthma and respiratory symptoms by sex, age and smoking in a community study early life risk factors for current wheeze, asthma, and bronchial hyperresponsiveness at years of age a -year follow up of a birth cohort study prognosis of asthma in childhood incidence and remission of asthma: a retrospective study on the natural history of asthma in italy comparison of a beta -agonist, terbutaline, with an inhaled steroid, budesonide, in newly detected asthma tenor study group. gender differences in igemediated allergic asthma in the epidemiology and natural history of asthma: outcomes and treatment regimens (tenor) study a comparison of bronchodilator therapy with or without inhaled corticosteroid therapy in obstructive airways natural history of asthma in childhood-a birth cohort study physician-diagnosed asthma and allergic rhinitis in manitoba: - food allergy as a risk factor for lifethreatening asthma in childhood: a casecontrolled study outcome of wheeze in childhood. symptoms and pulmonary function years later a sevenyear follow-up study of adults with bronchial asthma respiratory symptoms in young adults should not be overlooked lung function in young adults who had asthma in childhood childhood asthma and lung function in mid-adult life association between allergy and asthma from childhood to middle adulthood in an australian cohort study preschool wheezing and prognosis at wheezy bronchitis in childhood: a distinct clinical entity with lifelong significance? the state of childhood asthma in young adulthood decline in lung function in the busselton health study: the effects of asthma and cigarette smoking the characteristics of bronchial asthma among a young adult population mortality and decline in lung function in adults with bronchial asthma: a ten year follow up key: cord- -blwguyl authors: guleria, randeep; mathur, vartika; dhanuka, ashutosh title: health effects of changing environment date: - - journal: natural resource management: ecological perspectives doi: . / - - - - _ sha: doc_id: cord_uid: blwguyl environment plays a crucial role in our economic, social and cultural behaviour as well as on health. however, since the beginning of industrialization era, focus on economic development has caused detrimental effects on the environment. last two centuries have witnessed changes in global environmental factors such as rise in temperature leading to global warming, depletion of stratospheric ozone layer, loss of biodiversity and marked degradation in air and water quality due to atmospheric pollution, thereby causing upsurge in infectious and non-infectious diseases. environmental health has emerged as an important part of medicine. the world health organization (who) estimates that % of global disease burden and % of all deaths can be attributed to environmental factors. deaths from heart disease, cancer, respiratory disorders and many vector-borne diseases such as malaria, dengue, chikungunya and cholera have increased due to changes in climate, especially in developing countries. besides limited attention to sanitation, hygiene, as well as quality of food and drinking water, factors such as deforestation, increasing vehicular traffic, migration from rural to urban areas, decreasing water resources and inadequate drainage systems contribute to increase incidence of diseases. the need of the hour is to sensitize ourselves about the way our ecology is being degraded and the health effects it is causing. a holistic view is needed to address the problem of environmental health where agriculture, animal husbandry, public health, water safety and air pollution need to be looked at in a combined manner for education, planning and resource allocation. therefore, a close association between scientists, public health professionals and administrators is needed for integrated design and development of framework to attain harmony between man and nature. an ecosystem is defined as a community of living beings surviving and interacting in mutual and interdependent relationship with their physical environment. for thousands of years, man has lived in harmony with their natural surroundings. environment has played a crucial role in his economic, social and cultural behaviour as well as on his health. the role of environment in various diseases has been well documented, both in communicable and non-communicable diseases. since the dawn of industrialization era in europe years ago and its subsequent spread to the rest of world, economic development and physical comfort for mankind have increased at a tremendous pace. this increase is perhaps the most rapid over the last three decades. often this has been done, knowingly or unknowingly, at the cost of our environment. the last years have witnessed a sharp increase in the global temperature from its levels around years ago, owing to industrialization (mann et al. ; marcott et al. ) . moreover, other concerns such as depletion of carbon fuels at alarming rates, damage to the ozone layer and rise in seawater levels, combined with global warming, have damaged our environment extensively, leading to changes in the aquatic biodiversity and to the extinction of many species of plants and animals (thomas et al. ) . increase in urbanization has led to loss of dense forests. air pollution has risen to the extent that many big cities in the world have a highly toxic air quality. however, very little has been done by various governmental and non-governmental agencies with almost no visible results. the need of the hour is to sensitize the scientific community, as well as the common man, about the way our ecology is being degraded and the health effects it is causing and to suggest ways to get remedies for this situation. environmental health has emerged as an important part of medicine, due to the rapid environmental changes linked to industrialization and urbanization. it is being increasingly recognized that environmental factors play a key role in human health and are linked to many chronic and infectious diseases. deaths from heart disease and respiratory illness are increasing, and many diseases such as malaria, dengue, chikungunya and cholera are sensitive to changes in the climate (mcmichael et al. ; patz et al. ) . according to the world health organization (who), 'in its broadest sense, environmental health comprises those aspects of human health, disease and injuries that are determined or influenced by factors in the environment. this includes the study of both direct pathological effects of various chemical, physical and biological agents, as well as effects on health of the broad physical and social environment, which include housing, urban development, land use and transportation, industry and agriculture'. the who estimates that % of the global disease burden and % of all deaths can be attributed to environmental factors. moreover, environmental factors have a much bigger impact in developing countries than developed ones, and this effect is seen much more in the vulnerable population such as children and elderly. in a developing country like india, the burden of various diseases is increasing due to environmental factors and the changes in our environment. it is estimated that % diarrhoeal disease burden may be attributed to environmental factors such as unsafe food and drinking water, as well as poor sanitation and hygiene. similarly, in india there is strong evidence linking lower respiratory tract infection to indoor air pollution caused by the use of solid fuels in household. almost % of acute lower respiratory tract infections in developing countries are attributable to environmental factors. besides this, a close association of vector-borne diseases and environmental conditions has been established. furthermore, factors such as deforestation, increasing vehicular traffic, migration from rural to urban areas, decreasing water resources and inadequate drainage system are important environmental and ecological factors that contribute to infectious diseases. the temperature of the earth has increased by about . °c over the past years (griggs and noguer ; mccarthy ) . winters are shortening and average temperature is rising. intergovernmental panel on climate change (ipcc) of united nations predicts that the global temperature will rise by . - . °c by the turn of this century, if no remediable actions are taken (houghton et al. ). this will lead to rise in sea level by - cm and drowning of coastal cities, which comprise % of world's major cities (crutzen ; fitzgerald et al. ; nicholls and cazenave ) . higher temperatures will lead to melting of polar ice, melting of glaciers, floods and droughts (patz et al. ) . average temperature shall rise during both summers and winters. heat waves will increase, and average annual precipitation will also increase correspondingly. heat waves, floods and droughts lead to natural calamities, shortage of food supplies, increased risk of infectious diseases and increased human mortality (haines et al. ). clean water is essential for the survival of humans. water pollution due to environmental changes therefore constitutes another serious risk to the health of our planet. water pollution occurs when energy and substances are released and degrades the quality of water for other users. anything that is added to water, which is more than its capacity to break it down, constitutes water pollution. anthropogenic activities such as industrial waste effluents, sewage disposal and agricultural activities are some of the major causes of water pollution (manivasakam ; tilman et al. ) . chemical pollution of surface water causes major health problems as it can be used directly for drinking or it may contaminate shallow wells, used for drinking. ground water, which is much deeper, has very few pathogens as it gets filtered when it passes through many underground layers. it can be polluted by toxic chemicals such as fluoride and arsenic which may be present in the soil or the rock layers. similarly, pollution of coastal water can cause contamination of sea food (guleria ) . changing environment has a serious effect on safe water, affecting not only human health but also changing the ecology of plants. the global effect of water pollution has not been studied in detail and is limited to mainly outbreaks of waterborne infections or certain chemical toxins in limited areas, such as arsenic in drinking water in bangladesh, 'minamata' disease in japan, etc. (argos et al. ; harada ) . the burden of waterborne diseases is grossly underreported in india due to lack of data, poor surveillance and reporting. according to a report from the ministry of health and family welfare, nearly million people are affected by waterborne diseases such as diarrhoea, enteric fever, amoebiasis and helminthic infestations, every year. who estimates > , deaths annually, in india alone, due to contaminated water consumption. moreover, floods and droughts also affect human health. floods lead to physical injury as well as spread of waterborne diseases such as diarrhoea, enteric fever and viral hepatitis. overcrowding occurs and sanitation is affected, leading to respiratory infections. diseases such as malaria and dengue may turn into epidemics. on the other hand, drought leads to lack of sanitation, decreased food production and ultimately malnutrition. another aspect of waterborne diseases is chemical contamination leading to diseases such as fluorosis and methemoglobinemia, due to contamination of soil water owing to fluoride and fertilizers. chronic exposure to contaminated water can cause significant health effects and can lead to liver and kidney damages. this occurs due to chronic exposure to copper, cadmium, arsenic, mercury, chromium and chlorobenzene. endocrine effects have been reported, and problems relating to reproduction, development and behaviour have also been observed. enso is a cycle of seawater temperature and pressure changes occurring over the southern pacific ocean at an interval of - years and lasting for - months. this leads to episodes of floods in the southwest united states, mexico and western coast of latin america and droughts in southeast asia and the pacific islands (kovats et al. ). this may be followed by cold waves called la niña. higher global temperatures are predicted to lead to more frequent and severe ensos, and this will lead to significant effects on human health, in the coming years (bouma et al. ). change in the global climate has led to higher temperatures, humidity and floods, which has made the environment more conducive for parasites such as mosquitoes and fleas (patz et al. ) . malaria, dengue and other vector-borne diseases are expected to increase both in magnitude and their geographical reach (haines et al. ) . people living at higher altitudes may also likely experience resurgence in vector-borne diseases, due to a rise of average temperatures in these regions. moreover, these diseases can spread to any part of the world in a very short time (at times during the incubation period) and cause an outbreak in a community where these diseases do not usually occur, resulting in diagnostic difficulties. this has recently been seen during the ebola and the mers coronavirus outbreaks. other factors such as breakdown of public health infrastructure, shortage of medical supplies and changes in land use also contribute to adversities in health, due to water pollution. air pollutants affect the human body through the inhalational route. environmental changes due to industrialization have drastically altered the quality of the air we breathe. there are hundred substances that pollute the air and may harm human health. pollutants are generally classified as primary or secondary pollutants. chemicals that are directly emitted from a source are known as primary pollutants. these include sulphur dioxide, nitrogen oxides, carbon monoxide, volatile organic compounds, etc. moreover, particulate matter emitted due to combustion from automobile exhaust, heating, cooking and industrial sources are also primary pollutants. secondary pollutants, such as formaldehyde, nitric acid and different aldehydes, on the other hand, are formed from chemical or photochemical reaction in the atmosphere. on exposure to sunlight, volatile organic compounds and nitrogen oxides react photochemically, producing pollutants such as ozone. air pollution and occupational exposure may cause a variety of negative health outcomes, including reduced lung function in children as well as increased susceptibility to infections, airway inflammation and cardiovascular diseases. respiratory disorders due to air pollution are emerging to be a major contributor to mortality, according to recent epidemiologic studies. moreover, low-level air pollution is recently being recognized as a risk factor for lung diseases and death from copd (bosson and blomberg ) . with newer insights into the immunopathogenesis of asthma, the contribution of air pollution to allergen sensitization and airway hyperresponsiveness are being established. for example, increased exposure to nitrogen dioxide during infancy correlates with increased risk for asthma in later childhood. ozone can produce significant adverse effects on human health (gryparis et al. ; teague and bayer ; uysal and schapira ) . moreover, recent research is now linking air pollution to increased risk of respiratory symptoms and duration of respiratory tract symptoms. international agency for research on cancer recently designated diesel exhaust as a human carcinogen. sulphur oxides are produced mainly from industrial activities processing materials that contain sulphur, such as generation of electricity from coal, oil or gas, as well as by combustion of fossil fuels. sulphur dioxide is also present in motor vehicle emission. together with ozone, it is known to cause foliar injury and reduction in plant growth (smith ; tingey and reinert ) . it is mainly absorbed in the upper airways as it is water soluble. its exposure is known to cause symptoms such as nose and throat irritation. it may travel to the lower airways and cause bronchoconstriction and dyspnoea, especially in asthmatic individuals, thus worsening their condition (balmes et al. ; ierodiakonou et al. ) . nitrogen oxides are emitted primarily from motor vehicle exhausts, as well as from stationary sources such as electric utilities and industrial boilers. compounds such as sulphur and nitrogen oxides cause chemical reactions in air and acid rains. although acid rains do not affect humans radically, they may indirectly cause health problems, particularly difficulty in breathing and, in extreme cases, lung problems such as asthma or chronic bronchitis. moreover, nitrogen oxides are the main precursors in the formation of tropospheric ozone. they also form nitrate particles and acid aerosols. exposure to nitrogen dioxide for a short term leads to changes in airway responsiveness and deterioration in pulmonary function in individuals with underlying lung disease. long-term exposure may lead to increased chances of recurrent respiratory tract infections and alter lung mechanics (berglund et al. ) . carbon monoxide is produced mainly due to motor vehicle emission. in urban areas more than % of the carbon monoxide emission may be due to motor vehicles. besides this, the combustion of coal, oil and gas also leads to carbon monoxide production. moreover, tobacco smoke is one of the main sources of indoor pollution of carbon monoxide. high levels of carbon monoxide are extremely dangerous to humans, more so because it is colourless, tasteless and odourless and therefore cannot be detected by humans. early symptoms of carbon monoxide include weakness, headache, nausea, dizziness, confusion, disorientation and visual instability. carbon monoxide quickly enters the blood stream and forms carboxyhaemoglobin which causes more systemic effects. it reduces oxygen delivery to the tissues and may have a serious health threat to those with underlying heart disease (badman and jaffé ) . prolonged or severe exposure may result in lethal arrhythmias, electrocardiographic changes, pulmonary oedema, various neurological symptoms as well as death, most likely due to cardiac failure. carbon monoxide is known to cause foetal development disorders, brain lesions and, in extreme cases, even mortality (raub et al. ) . the atmospheric levels of lead have decreased due to the use of unleaded fuel. however, lead toxicity continues to be a problem, due to the exposure occurring in drinking water. lead exposure leads to adverse effects on the central nervous system, causing neurological symptoms such as sleep disorders, fatigue, trembles in limbs, blurred vision and slurred speech, as well as kidney and liver disorders (kampa and castanas ) . lead toxicity can lead to lower intelligence, learning deficits and behavioural disturbances. ozone is an important secondary pollutant and is a component of photochemical smog. it is a pulmonary irritant and an oxidant. it may produce significant adverse effects on human health. exposure to ozone causes airway inflammation, airway hyperreactivity and a decline in lung functions. ozone exposure causes cough, chest tightness and wheezing. the increase in the levels of tropospheric ozone is associated with reduced baseline lung functional as well as structural abnormalities, exacerbation of asthma and premature mortality. recent studies have shown increased admissions for chest complaints and worsening of asthma on exposure to even low levels of ozone. studies looking at long-term exposure to ozone suggest that a cumulative long-term exposure in childhood may affect lung function, especially that of the small airways of the lung, in adult life (künzli et al. ) . ozone also affects mucous membrane and causes pulmonary inflammation and has both a local and systemic effect on the immune system. patients with underlying respiratory illness such as asthma and chronic obstructive airway disease are more prone to the harmful effect of ozone. high ozone concentrations have been linked with increased hospital admissions for pneumonia, copd and asthma (gryparis et al. ; teague and bayer ; uysal and schapira ) . particulate matter consists of liquid or solid mass contained in an aerosol. it is a mixture of numerous different chemicals, with varying properties. major sources of particulate matter are factories, power plants, incinerators, motor vehicles, construction activities, fire and dust. broadly particulate matters from . to μm in diameter are coarse particulate matter. coarse particulate matter consists mainly of airborne soil dust and elements such as silicon and aluminium. fine particles of less than . μm are composed mainly of sulphate and organic material. particulate matter in air is associated with allergic rhinitis, lung inflammation, pulmonary disorders, cardiac arrhythmia, ischemic cardiovascular events, higher incidences of cancer and shortening of life (carlsten and georas ; dockery et al. ; kampa and castanas ; pope iii et al. ; raaschou-nielsen et al. ) . only recently we began to understand the cardiovascular effects of air pollution. high levels of air pollution worsen underlying heart disease. but now it is becoming clear that persistent exposure to high levels of air pollution may also lead to heart disease. this is especially true for particulate matter. inflammation in lungs also causes inflammation in the blood, leading to atherosclerosis and an increase incidence of coronary artery disease that may be fatal (fig. . ). many well-conducted studies have demonstrated a - % higher risk of coronary artery disease in individuals exposed to high levels of air pollution, for many years (cesaroni et al. ; miller et al. ). this increased risk has been linked to higher levels of pm . in the ambient air. studies have also looked at subclinical atherosclerosis, which is the pathological process associated with coronary artery disease. a positive association between subclinical atherosclerosis in the carotid and the coronary arteries has been observed with long-term exposure to high levels of air pollution (künzli et al. ; künzli et al. ) . there is therefore now a significant body of evidence linking air pollution to cardiovascular diseases and increased mortality. many investigators argue that air pollution should now be considered as a preventable risk factor like smoking and dyslipidemia for the development of coronary artery disease, and steps should be taken to bring down the exposure to air pollution. indoor air pollution and its effect on human health are important as individuals spend more than % of their time indoors. cooking is an integral part of indoor human activity. the who has estimated that about % of the world's population, or about billion people, still uses solid fuel for their household energy needs. of these, about . billion people use biological material (wood, charcoal, crop waste and dung), and the remaining use coal. in india, about % of the population has been estimated to depend upon wood, and about % depend upon dung for energy. although this number is slowly decreasing and moving towards the use of other fuels such as liquefied petroleum gas (lpg) and kerosene, it is still very significant. in india in , of the . billion people, about million still used solid fuel for cooking or heating. many studies over the last three decades have documented the link between solid fuel exposure and different respiratory diseases. lim et al. ( ) estimated more than million premature deaths per year due to indoor air pollution, because of solid fuel used for cooking purposes. exposure to high concentrations of harmful substances in smoke during use of biomass fuel causes significant illness amongst homemakers and young children. it has been shown that biomass fuel is a less efficient means of energy production and a number of carcinogenic constituents are released during biomass combustion (chafe et al. ; smith and sagar ) . inhalation of these particles in high concentration leads to 'lung overloading' and sustained inflammation. this results in the release of reactive oxygen that causes deoxyribonucleic acid (dna) damage. indoor smoke produced due to burning of solid fuel contains many pollutants. particulate matter, nitrogen oxides, carbon monoxide, benzene, . butadiene, polycyclic aromatic hydrocarbons, free radicals and volatile organic compounds are many of the toxic substances that have been found in smoke produced by burning solid fuels. chronic exposure to these harmful substances leads to lung fibrosis and subsequently the development of lung cancer. the evidence for the development of lung cancer due to biomass exposure has been shown in experimental animals, but the evidence in humans is not that strong. indoor air pollution thus accounts for a significant proportion of the global burden of disease in developing countries. the link between solid fuel exposure and chronic obstructive lung disease in women and acute respiratory tract infection in children is strong. the commendable initiative by the government of india called 'give it up' is a step in trying to decrease the effects of indoor air pollution on human health. also steps to improve ventilation in kitchens or use smokeless stoves chulla may also help in reducing the exposure to indoor air pollution (reddy et al. ). waste generated from used electronic devices and household appliances constitutes e-waste. it comprises of a wide range of equipments and devices falling under 'hazardous' and 'non-hazardous' categories such as computers, mobile phones, refrigerators, washing machines, air conditioners, personal stereos, consumer electronics, etc., that are discarded by users (puckett et al. ) . pollution due to electronic and electrical waste has rapidly grown over the last decade due to progressive increase in production of electronics, lack of proper disposal facilities in india and dumping of e-waste from developed countries. in alone, india generated about . million tons of e-waste (double the amount as compared to ), which is progressing rapidly. e-waste may contain many toxic substances which may be harmful to the environment and human health. this can have a significant economic and social impact on society. iron and steel constitute about % of the e-waste followed by plastics ( %), nonferrous metals ( %) and other constituents ( %). others include nonferrous metals like copper, aluminium, silver, gold, platinum, palladium, etc. the presence of elements such as lead, mercury, arsenic, cadmium, selenium and hexavalent chromium, with flame retardants beyond threshold quantities of e-waste, classifies them as hazardous waste. manual recycling of e-waste is done predominantly via the unorganized sector, and the work force involved consists predominantly of individuals with low literacy and hardly any training to protect themselves from ill effects and to identify warning signals of toxicity. accordingly, a significant percentage of health problems due to e-waste results from direct contact with harmful materials and inhalation of toxic fumes. moreover, these materials may get accumulated in the food and water and are consumed. heavy metals such as lead can cause kidney failure, neurologic manifestations and hypertension. mercury toxicity can lead to central and peripheral nervous system damage and hepatic and renal toxicity (guleria ) . furthermore, uncontrolled burning, disposal and dismantling of e-waste can cause a number of problems including air pollution and water pollution. there is a lack of an environmentally effective recycling infrastructure for e-waste, and this leads to pollution of the environment. this is gradually changing our ecology. there is, therefore, a need to increase public awareness about the harmful effects of e-waste and develop an effective recycling and disposal plan, to prevent or minimize air and water pollution. there should be general awareness of how changes in climate and environment lead to significant acute and chronic effects on human health. these effects can be both for infectious and non-infectious illnesses. a holistic view is needed to address the problem of environmental health where agriculture, animal husbandry, public health, water safety and air pollution need to be looked at in a combined manner for education, planning and resource allocation. general population should also be made aware about the ways to reduce harm to our environment. intergovernmental efforts should be made to check climate change, avoid deforestation and use alternative sources of energy like solar energy instead of petroleum products. ultimately, as embedded in its definition, ecosystem is a community, and unless all people in community put efforts to conserve it, no amount of individual effort can suffice. therefore, a close teamwork between scientists, public health professionals and administrators is needed for integrated vertical and horizontal planning. arsenic exposure from drinking water, and all-cause and chronic-disease mortalities in bangladesh (heals): a prospective cohort study blood and air pollution; state of knowledge and research needs symptomatic bronchoconstriction after shortterm inhalation of sulfur dioxide health risk evaluation of nitrogen oxides update in environmental and occupational medicine global assessment of el niño's disaster burden update in environmental and occupational lung diseases long term 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india's chulha trap outdoor air pollution: asthma and other concerns extinction risk from climate change forecasting agriculturally driven global environmental change the effect of ozone and sulphur dioxide singly and in combination on plant growth effects of ozone on lung function and lung diseases key: cord- -j riw ir authors: stikova, elisaveta; gjorgjev, dragan; karadzovski, zarko title: strengthening the early-warning function of the surveillance system: the macedonian experience date: - - journal: emerging and endemic pathogens doi: . / - - - - _ sha: doc_id: cord_uid: j riw ir epidemics and pandemics can place sudden and intense demands on health systems. the world requires a global system that can identify and contain public health emergencies rapidly and reduce panic and disruption of trade, travel, and society in general. strengthening public health preparedness requires establishing an integrated global alert and response system for epidemics and other public health emergencies along the lines of the world health organization’s international health regulations. the revised international health regulations provide a global framework to address these needs through a collective approach to the prevention, detection, and timely response to any public health emergency of international concern. a standardized approach for readiness and response to major epidemic-prone diseases should be developed. an early-warning and rapid-alert system is one of the possibilities to improve readiness at the local, regional, national, and international level to limit the spread of disease and to reduce health, economic, and social damage. the republic of macedonia, with world health organization support, has implemented an earlywarning system (alert) for priority communicable diseases to complement the routine surveillance system that reports individual confirmed cases. alert relies on reporting of eight syndromes by primary care facilities. data are analyzed weekly at the regional level and transmitted to national epidemiologists. it is perceived to be a simple and flexible tool for detecting and triggering timely investigation and control of outbreaks. alert was identified as a useful instrument for forecasting and detecting the start of the influenza season. at the beginning of the st century, the world still confronts: globally, from to december , the world health organization (who) identified , syndromes and diseases that were potential public health emergencies of international concern. of these events, subsequently were verified in the who european region [ ] . region reported cases of sars, including one death, from february through july . this figure corresponds to % of the cases reported worldwide over the same period. communicable diseases in the european region account for % of the disease burden measured in disability-adjusted life years. this is largely attributable to high rates of tuberculosis and growing rates of hiv infection, particularly in central and eastern european countries and in central asia, and to emerging and reemerging epidemic-prone diseases. some of the most prominent public health programs currently being undertaken are the eradication of smallpox, the ongoing efforts to eradicate poliomyelitis and to eliminate measles, the expanded programme on immunization, the stop tb partnership, the coordination of the global epidemic response to control sars, and the ongoing efforts to contain the spread of influenza a/h n virus (avian influenza) and to prepare for pandemic influenza. we must be aware, however, that widening development gaps, the collapse of public health infrastructure, poverty, urbanization, civil strife, environmental change and degradation, and the globalization of travel and trade can contribute to the new challenges posed by epidemic-prone and emerging communicable diseases worldwide. • the emergence of new or newly recognized pathogens such as nipah virus, ebola virus, marburg virus, severe acute respiratory syndrome (sars) corona virus, and influenza a/h n virus • the recurrence of well-characterized epidemic-prone diseases such as cholera, dengue, influenza, measles, meningitis, shigellosis, and yellow fever • the accidental release or deliberate use of biological agents such as anthrax [ ] in addition to the events described in table , member states in the european these are reasons for public health-capacity building at the local, national, and international level and strengthening of public health preparedness and response systems around the world [ , ] . avian influenza is a major challenge for the international community and a real public health threat. globally, as of june , , laboratory-confirmed human cases of influenza a/h n virus infection, including fatal cases (case-fatality rate about %), had been registered in member states. in the european region in , human cases including nine deaths were reported in turkey ( cases and four deaths) and azerbaijan (eight cases and five deaths) [ ] . many international organizations, including who, and experts are working together to coordinate activities regarding key actions, including controlling avian influenza in animals and reducing opportunities for human infection; strengthening the earlywarning system; containing or delaying the spread at the source; reducing morbidity, mortality, and social disruption; and conducting research to guide response measures. the challenges that epidemic-prone diseases, including avian influenza, pose to who are: the revised international health regulations (ihr) [ ] , which entered into force in june , provide a legal framework to assist countries in protecting the health of their populations against any potential public health emergency of international concern, implementing the necessary measures, and contributing to making the world more secure [ , ] . national and international partnerships will maximize the benefit of strengthening surveillance and response [ , ] . to ensure the timely detection of events that are potential public health emergencies of international concern, the who regional office for europe, aside from relying on official reports from national health authorities, systematically screens a wide range of formal and informal sources of information in several languages. the monitoring and control of communicable diseases are facilitated by wellfunctioning surveillance systems. surveillance systems provide information for early detection of potential outbreaks and help to identify disease trends, risk factors, and the need for interventions [ , ] . they provide information for priority setting, planning, implementation, resource allocation, and for evaluating preventive programs and control measures. surveillance systems are set up to detect and control communicable diseases in humans regardless of the cause and manner of transmission. their principal aim is to prevent further transmission of the disease to other persons by epidemiologic investigation [ , ] . the timely detection of outbreaks at the regional and national level is a priority function of communicable disease surveillance systems. in the process of implementing its ihr [ ] , who included the requirement for member states to maintain an adequate core capacity to detect and respond to significant public health threats. this requires that member states develop effective early-warning systems and strengthen their investigation and response capabilities [ , ] . • how to minimize the risk of international spread • how to assist countries in preparing for and controlling epidemics • how to coordinate and focus global resources when no single institution has the necessary capacity [ , ] since december , central and eastern europe and the baltic countries have worked together to strengthen surveillance and early-warning and response systems [ ] . to ensure a rapid and effective response to events (including emergencies) related to communicable diseases, an early-warning and response system has been put in place in macedonia. this is a web-based system linking the regional public health institutes (rphis) with the national public health institute (nphi) and the ministry of health. innovative electronic surveillance systems are being developed to improve early detection of outbreaks attributable to biologic and other causes of threats. a review of the rationale, goals, definitions, and realistic expectations for these surveillance systems is a crucial first step toward establishing a framework for further research and development in this area [ ] . syndromic surveillance has been used for early detection of outbreaks; to follow the size, spread, and tempo of outbreaks; to monitor disease trends; and to provide reassurance that an outbreak has not occurred [ ] . syndromic surveillance systems seek to use existing health data in real time to provide immediate analysis and feedback to those charged with the investigation and follow-up of potential outbreaks. optimal syndrome definitions for continuous monitoring and specific data sources best suited to outbreak surveillance for specific diseases have not been determined [ , ] . broadly applicable signal-detection methodologies and response protocols that would maximize detection while preserving scant resources are being sought [ , ] . stakeholders need to understand the advantages and limitations of syndromic surveillance systems. syndromic surveillance systems might enhance collaboration among public health agencies, health-care providers, information-systems professionals, academic investigators, and industry. however, syndromic surveillance does not replace traditional public health surveillance, nor does it substitute for direct physician reporting of unusual or suspect cases of public health importance [ , ] . specific definitions for syndromic surveillance are lacking, and the name itself is imprecise. diverse names used to describe public health surveillance systems for early outbreak detection include: however, syndromic surveillance is the term that has persisted. the fundamental objective of syndromic surveillance is to identify illness clusters • early-warning systems • prodrome surveillance • outbreak-detection systems • information system-based sentinel surveillance • biosurveillance systems • health-indicator surveillance • symptom-based surveillance early, before diagnoses are confirmed and reported to public health agencies, and to mobilize a rapid response, thereby reducing morbidity and mortality. syndromic surveillance aims to identify a threshold number of early symptomatic cases, allowing detection of an outbreak earlier than would conventional reporting of confirmed cases [ ] . the ability of syndromic surveillance to detect outbreaks earlier than conventional surveillance methods depends on such factors as the size of the outbreak, the population dispersion of those affected, the data sources and syndrome definitions used, the criteria for investigating threshold alerts, and health-care providers' ability to detect and report unusual cases [ ] . syndromic surveillance focuses on the early symptom (prodrome) period before clinical or laboratory confirmation of a particular disease and uses both clinical and alternative data sources. strictly defined, syndromic surveillance gathers information about patients' symptoms (e.g., cough, fever, shortness of breath). the analytic challenge in using syndromic surveillance for outbreak detection is to identify a signal corresponding to an outbreak or cluster amid substantial "background noise" in the data [ ] . however, signal-detection methods have not yet been standardized. temporal and spatio-temporal methods have been used to assess day-to-day and day and place variability of data from an expected baseline [ , ] . the new ihr [ ] entered into force on june , . the ihr are ( ) a legal framework for surveillance of international health threats, ( ) a procedure for who's recommendations to counteract public health emergencies of international concern, and ( ) a set of rules concerning routine measures against international disease spread. here we will briefly review the first of these features. in the globalized world, diseases can spread far and wide via international travel and trade. a health crisis in one country can affect livelihoods and economies in many parts of the world. such crises can result from emerging infections such as sars or a new human influenza pandemic. the ihr also can apply to other public health emergencies such as chemical spills, leaks, and dumping or nuclear accidents [ ] . the ihr aim to limit interference with international traffic and trade, ensuring public health through the prevention of disease spread. the ihr require countries to report certain disease outbreaks and public health events to who [ , , ] . building on the unique experience of who in global disease surveillance, alert, and response, the ihr define the rights and obligations of countries to report public health events and establish a number of procedures that who must follow in its work to uphold global public health security. within the framework of the ihr [ ] , seven areas of work have been identified to achieve the goals described above. the first area of work aims to strengthen global partnerships; the second and third address countries' capacities to meet ihr requirements; the fourth and fifth areas of work focus on surveillance, prevention, control, and response systems at the international level; and the sixth and seventh address awareness of rules and legal aspects and measuring progress ( table ) . the risk of international spread of disease is minimized through effective permanent public health measures and response capacity at designated airports, ports and ground crossings in all countries. prevent and respond to international public health emergencies . strengthen who global alert and response systems timely and effective coordinated response to international public health risks and public health emergencies of international concern. . strengthen the management of specific risks systematic international and national management of the risks known to threaten international health security, such as influenza, meningitis, yellow fever, sars, poliomyelitis, food contamination, chemical and radioactive substances. there are three groups of events that may constitute public health emergencies of international concern: group . a case of the following diseases is unusual or unexpected and may have serious public health effects and thus shall be reported: group . an event involving the following diseases shall always lead to use of the algorithm because these diseases have demonstrated the ability to have serious public health effects and to spread rapidly internationally: • smallpox • poliomyelitis due to wild-type poliovirus • human influenza caused by a new subtype • severe acute respiratory syndrome (sars) • cholera • pneumonic plague • yellow fever • viral haemorrhagic fevers (ebola, lassa, marburg) • west nile fever • other diseases that are of special national or regional concern, e.g., dengue fever, rift valley fever, and meningococcal disease group . any event of potential international public health concern, including those of unknown causes or sources and those involving events or diseases other than those listed above shall lead to use of the algorithm and criteria from the republic of macedonia has population of about two million people. the territory is divided into municipalities. in , in the framework of the new public health system, one national and rphis were established. they adopted a previously established system for routine surveillance for registration and notification of communicable diseases, which included diseases. in , new recommendations for protecting the population from communicable diseases were adopted, and a new obligatory list of diseases was introduced. past work has shown an absence of case definitions, a lack of laboratory confirmation, significant delays in reporting between surveillance levels, delayed and inadequate outbreak response, lack of feedback to reporting level, lack of training, lack of analysis at the peripheral level, under-reporting of unconfirmed cases or outbreaks, and poor motivation of healthcare staff. in , the nphi, with who support, started to develop a syndromic early-warning alert response system (ewars), called alert, with an ultimate goal of strengthening the early detection of outbreaks of epidemicprone and emerging infectious diseases. a panel of macedonian experts in the field of epidemiology and microbiology has assessed the needs and priorities for disease surveillance using a standardized questionnaire. the aim of this assessment was to define what the most important diseases are in republic of macedonia, from their point of view. the results of the assessment are shown in table . acute bloody diarrhea mucous stools containing (visible) blood in the previous h, with or without dehydratation, stomach pain, and cramps suspicion of acute infective hepatitis acute jaundice (yellow skin and sclera colour), weakness and exhaustion, dark urine, light stool, anorexia, nausea, pain below the right rib arch suspicion of acute hemorrhagic fever acute beginning of fever in a period shorter than weeks in a very ill patient and any two of the following signs/symptoms: petechial or purpural rash, nose bleeding, hematemesis, hemoptysis, oliguria or anuria, bloody stool, any other hemorrhagic manifestation without known cause in children younger than a list of eight health events was included in alert on the basis of the results of this study. to unify the reporting process for all participants in the system, a case definition is necessary. a case definition is a combination of symptoms and signs that have to be present in a patient for the patient to be placed in a certain category. the list case definitions for each. after the decision was made about the syndromic diseases that would be included in the ewars, the next challenge facing the expert panel was to make a decision about the threshold limits. two different approaches have been used for threshold definition. regarding the severity of the disease and expecting threats for three of the syndromic diseases, the fixed number of cases was used. for the other five syndromic diseases, threshold limits were established on the basis of previous epidemiologic data and already-registered cases. using these two methodologies, threshold limits were alert will go out automatically. for three groups of syndromic events -meningitis and meningoencefalitis, acute bloody diarrhea, and acute hemorrhagic fever -an alert will be declared after every registered case. for the other five syndromic events, an alert will be declared after the defined number of cases specific for each region of surveillance is exceeded. reporting units all are comprised of primary care physicians who work in different segments of the health system in the republic of macedonia. currently there are , primary health units, but only - % of them are included in ewars. through a written, standardized surveillance form, they report weekly the aggregated number of new cases in four age groups to the corresponding collecting units at the municipality level or directly to the local and regional surveillance units. they send aggregated data by mail or fax. there are ten regional surveillance units equipped and trained to process of eight syndromes that are part of the national ewars are presented in table with established for all ten surveillance units. they are shown in table . anytime the defined number of syndrome cases listed in table is exceeded, the data from the reporting units. the regional surveillance units are rphis and their epidemiologic departments. at the regional level, data are computerized and electronically transmitted to the nphi. the nphi prepares a report and sends it to the ministry of health and initiates and performs all requested interventions and additional activities. feedback is sent electronically from the nphi to the regional institutes. in addition, the rphis can send information to the reporting units. epidemiologists from the rphis and the nphi are responsible for data control and regularity, reporting any unusual changes and undertaking urgent activities. a program has been developed using public-domain software for relational data entry (epidata) and production of interactive reports (epiinfo). it includes features for data entry (with quality checks) at the rphi level and electronic transfer of records to the nphi. it provides links with excel and word. the application produces a weekly epidemiologic bulletin in word and allows interactive browsing of tables, charts, and maps in html format. the system generates alert reports based on disease-specific thresholds. the communicable diseases surveillance system in the republic of macedonia the system is considered simple and flexible. users emphasized that alert has improved communication between reporting and surveillance units and strengthened the surveillance network. the acceptability of the system is higher at the national level mainly because data from alert are received in a timely fashion, which allows the surveillance department at riph to monitor potential outbreaks at the national level. is shown in fig. . using syndromic case definitions allows remote areas that do not usually report, because of lack of confirmation capacity, to report, thereby providing valuable early-warning information. moreover, for some rare and serious diseases such as those targeted by the hemorrhagic fever syndrome, alert is used as zero reporting. syndromic surveillance is simple and often the only available surveillance tool at the primary health care level when laboratory confirmation of disease is not possible [ ] . it allows detection of potential outbreaks of targeted diseases earlier than with the diagnosis-based routine surveillance system and leads to field investigations for confirmation and control [ , ] . experience has shown that reporting units at the primary health care level are not the most appropriate source of notification for early detection of some epidemic-prone diseases. some specific syndromes may be seen first in emergency departments, private clinics, or pharmacies [ ] . syndromes such as hemorrhagic fever, as an indicator for hantavirus or crimean-congo hemorrhagic fever, are sensitive and specific enough to detect outbreaks. because it is a serious and uncommon syndrome, each individual case reported is an alert and triggers an action. for other diseases, such as influenza, targeted by acute respiratory illness, the alert for action is a rise in reported syndrome cases, indicating the onset of the influenza season. alert was able to detect this increase during the season. however, other categories of syndromes have not been sensitive or specific enough to detect outbreaks in a timely fashion. timely detection of public health threats relies on proper analysis of early-warning data at each level. alert software produces automated tables, charts, and maps highlighting increases. epidemiologists should use those resources to trigger actions when individual confirmed cases are reported. the evaluation of the effects of implementation of the pilot project for the ewars have shown us that sensitivity and usefulness should be increased. there are many possible ways to do this, such as adding emergency departments as notification sources for some syndromes, better defining the role of the laboratory to confirm the suspicion of outbreaks, revising the list and definition of syndromes to adjust their sensitivity and specificity for detecting the targeted diseases, and strengthening data analysis through training. our experience shows that the role of training should not be overlooked. it is a change of paradigm, which is impossible to induce by simply implementing new surveillance tools, difficult to induce by short training, and best induced by coaching programs such as field-epidemiology training programs. although the process for implementing the ewars was piloted by the ministry of health, the alert reporting procedures were not incorporated into public health laws. alert does not interrupt the continuity of the existing reporting system, regulated by law. all obligations and responsibilities prescribed by it still remain. the final goal is, by comparing the advantages and disadvantages of both systems, to enable the creation (establishment) of a new, combined system that would be more functional, safer, and more economically sustainable. on the basis of our experiences, the obligation for syndromic reporting through ewars will be laid down in our national law. some additional measures, such as financial copayment for reporting units, should be discussed. world health organization. the world health report enhancing health security: the challenges in the who european region and the health sector response. copenhagen: world health organization regional office for europe public health threats and disaster management world health organization. fifty-eighth world health assembly. resolution wha . . revision of the international health regulations. geneva: world health organization global public health surveillance under the new international health regulations public health emergencies of international concern and the revision of the international viewarticle.aspx? towards health security. a discussion paper on recent health crises in the who european region. copenhagen: world health organization regional catalogue risk reduction and emergency preparednes. who six-year strategy for the health sector and annual disaster statistical review: numbers and trends strengthening 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of a national public health surveillance.org/viewarticle.aspx?articleid= notifiable disease surveillance and practicing physicians what is epidemic intelligence, org/viewarticle.aspx? if syndromic surveillance is the answer, what is the question? surveillance for early detection and monitoring of infectious disease outbreaks associated with bioterrorism the global public health intelligence network and early warning outbreak detection: a canadian contribution to global public health strengthening early warning function of surveillance in the republic of serbia: lessons learned after a year of articleid= the emerging science of very early detection of disease outbreaks syndromic surveillance: a local perspective microbial threats to health: emergence, detection, and response syndromic surveillance and bioterrorism-related epidemics enhanced drop-in syndromic surveillance epidemiological response to syndromic surveillance signals updated guidelines for evaluating public health 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aberration reporting system (ears) different approaches to gathering epidemic intelligence in europe the epidemic intelligence service in the united states innovative surveillance methods for rapid detection of disease outbreaks and bioterrorism: results of an interagency workshop on health indicator surveillance key: cord- -pnjhi cu authors: foreman, stephen; kilsdonk, joseph; boggs, kelly; mouradian, wendy e.; boulter, suzanne; casamassimo, paul; powell, valerie j. h.; piraino, beth; shoemaker, wells; kovarik, jessica; waxman, evan(jake); cheriyan, biju; hood, henry; farman, allan g.; holder, matthew; torres-urquidy, miguel humberto; walji, muhammad f.; acharya, amit; mahnke, andrea; chyou, po-huang; din, franklin m.; schrodi, steven j. title: broader considerations of medical and dental data integration date: - - journal: integration of medical and dental care and patient data doi: . / - - - - _ sha: doc_id: cord_uid: pnjhi cu dental health insurance coverage in the united states is either nonexistent (medicare and the uninsured), spotty (medicaid) and limited (most employer-based private benefit plans). perhaps as a result, dental health in the united states is not good. what public policy makers may not appreciate is that this may well be impacting medical care costs in a way that improved dental benefits would produce a substantial return to investment in expanded dental insurance coverage. have been rising at double digit rates. most employers have been dropping health care coverage rather than expanding it ( kaiser family foundation ) . medicare trust funds are bankrupt (social security and medicare boards of trustees ). adding coverage would exacerbate an already alarming problem. medicaid funding is a major source of state government defi cits. many states are slashing medicaid coverage during this time of crisis (wolf ). improving medicaid dental coverage during times of budget crisis would meet substantial political resistance. strikingly, strong and increasing evidence suggests relationships between oral health and a range of chronic illnesses. for example, recent fi ndings show relationships between periodontal infl ammatory conditions and diabetes, myocardial infarction, coronary artery disease, stroke, preeclampsia and rheumatoid arthritis. this suggests that improved oral health may well have the potential to reduce the incidence of chronic diseases as well as their complications. if chronic disease incidence is reduced it may be possible to avoid medical care costs related to treating them. it would be important to know more about the extent to which improved oral health could reduce health care costs and improve lives. there are few, if any, studies of the costs of providing medicare dental benefi ts, the costs of improving the medicaid dental benefi t or the cost of providing dental insurance to the uninsured. there are a few studies that indicate that periodontitis increases medical care costs, perhaps by as much as % (ide et al. ; albert et al. ) . ideally there should be a controlled study to assess the benefi t of providing dental coverage through a government payer system. for a preliminary inquiry we can consider work already done and using some cost and benefi t estimates, determine whether it is possible that benefi ts of extending dental coverage may outweigh costs. the failure of medicare to cover dental care has engendered some (albeit not much) public debate. in , congress enacted the medicare prescription drug, improvement, and modernization act (medicare part d). by medicare provided $ . billion in benefi t payments for outpatient prescription drugs and medicaid paid . billion for outpatient prescription drugs (center for medicare and medicaid services ) . benefi ciaries provided billions more in the form of monthly part d premiums. the expense of the medicare prescription drug program and the controversy surrounding its enactment may well have eroded public support for increased medicare coverage. so while there has been no shortage of effort paid to improving medicare, the one common theme in all of the recent initiatives is that dental care has been conspicuously a new study by hedlund, jeffcoat, genco and tanna funded by cigna of patients with type ii diabetes and periodontal disease found that medical costs of patients who received maintenance therapy were $ . per year lower than patients who did not. cigna, research from cigna supports potential association between treated gum disease and reduced medical costs for people with diabetes, http://newsroom.cigna.com/newsreleases/research-from-cigna-supports-potential-association-between-treated-gum-disease-and-reduced-medical-costs-for-people-with-diabetes. omitted. as a result, million medicare recipients in (us census bureau ) continue to have no dental insurance coverage through medicare. medicaid dental coverage is an optional benefi t that states may or may not elect to provide. in medicaid, both the state and the federal government provide funds to cover healthcare services to eligible patients. the bulk of the money comes from the federal government. because the medicaid dollars are limited and coverage for systemic diseases has precedence, medicaid coverage of dental care has been spotty. even where it has been provided, payments to dental providers have been so low as to make it diffi cult or impossible for medicaid benefi ciaries to obtain adequate dental care (broadwater ) . the recession increased the number of medicaid eligible individuals nationwide. further, the federal budget defi cits of the past few years have reduced the federal contribution to state medicaid programs. the combination of increases in the number of benefi ciaries and diminished revenues has caused a number of states to eliminate or curtail medicaid dental coverage (ehow ; mullins et al. ) . the result, million medicaid benefi ciaries in the us (us census bureau ) in either had no dental insurance coverage or inadequate coverage. approximately million people in the united states do not have health insurance (kaiser family foundation ) . presumably, they have no dental insurance either. further, not every employer provides dental insurance. a cdc survey found that . % of adults do not have dental insurance coverage (centers for disease control ) . a montana survey found that % of employers who offer health insurance do not offer dental insurance coverage (montana business journal ) . in there were approximately million people enrolled in health insurance plans (us census bureau ) . if half (a rough combination of the cdc and montana percentages) of them do not have dental insurance it is likely that an additional million (nonelderly, non-poor) people in the us do not have dental insurance coverage. finally, the term "dental insurance" is actually a misnomer. dental policies cover routine treatments, offer discounts for more complex treatment and impose a low yearly on total payments. in fact, it has been called "part insurance, part prepayment and part large volume discount" (manski ) . effectively, many (if not most) people who have dental insurance fi nd it coverage to be quite restrictive. for example, many impose a small yearly cap ($ , is common) or large coinsurance amounts ( % for orthodontia, for example) (rubenstein ) . even with discounts it is easy for many people to exceed the annual limit. given the lack of dental insurance coverage it is not surprising that the status of oral health in the us is not particularly good. in approximately . % of adults between the ages of and had untreated caries, % had decayed, missing and fi lled tooth surfaces and more than one-half of adults had gingival bleeding (dental, oral and craniofacial data resource center of the national institute of dental and craniofacial research ) . three fourths of adults in the us have gingivitis and % have periodontitis (mealey and rose ) . if these levels of untreated disease were applied to most systemic diseases, there would be public outcry. over the past decade evidence has been building that there is a relationship between dental disease, particularly periodontal disease, and chronic illnesses. mealey and rose note that there is strong evidence that "diabetes is a risk factor for gingivitis and periodontitis and that the level of glycemic control appears to be an important determinant in this relationship" (mealey and rose ) . moreover, diabetics have a six times greater risk for worsening of glycemic control over time compared to those without periodontitis and, periodontitis is associated with an increased risk for diabetic complications. for example, in one study more than % of diabetics with periodontitis experienced one or more major cardiovascular, cerebrovascular or peripheral vascular events compared to % of the diabetic subjects without periodontitis (thorstensson et al. ) . also, a longitudinal study of type diabetics found that the death rate from ischemic heart disease was . times higher in subjects with severe periodontitis and the death rate from diabetic nephropathy was . times higher (saremi et al. ) . clinical trials have demonstrated that treatment of periodontal disease improved glycemic control in diabetics (miller et al. ) . moreover, investigations have found an association between periodontal disease and the development of glucose intolerance in non-diabetics (saito et al. ) . while it is diffi cult to establish causality and it is possible that other factors infl uence periodontal disease and medical complications, these studies suggest that treatment of periodontitis substantially improves health and greatly reduces medical complications related to diabetes. similarly, periodontitis is associated with cardiovascular disease and its complications including ischemia, atherosclerosis, myocardial infarction and stroke. a study by slade and colleagues found both a relationship between periodontitis and elevated serum c-reactive protein levels (systemic marker of infl ammation and documented risk factor for cardiovascular disease) as well as a relationship among body mass index, periodontitis and crp concentrations (slade et al. ) . hung and colleagues evaluated the association between baseline number of teeth and incident tooth loss and peripheral arterial disease. they determined that incident tooth loss was signifi cantly associated with pad, particularly among men with periodontal disease potentially implying an oral infection-infl ammation pathway (hund et al. ) . the same group of researchers used the population enrolled in the health professionals' follow-up study ( , men free of cardiovascular disease and diabetes at baseline) to assess the relationship between tooth loss and periodontal disease and ischemic stroke. controlling for a wide range of factors including smoking, obesity, and dietary factors, the researchers found a "modest" association between baseline periodontal disease history and ischemic stroke . as early as destefano and colleagues found that among subjects, those with periodontitis had a % increased risk of coronary heart disease relative to those without. the association was particularly high among young men. the authors questioned whether the association was causal or not, suggesting that it might be a more general indicator of personal hygiene and possibly health care practices (destefano et al. ) . in wu and colleagues used data from the first national health and nutrition examination survey and its epidemiologic follow-up study to examine the association between periodontal disease and cerebrovascular accidents. the study found that periodontitis was a signifi cant risk factor for total cva, in particular, for non-hemorrhagic stroke (wu et al. ) . in addition to diabetes and coronary artery disease, associations have been found between periodontal disease and rheumatoid arthritis and respiratory disease. this is not surprising given the role of periodontal disease in the production of infl ammation related proteins. dissick and colleagues conducted a pilot study of the associate ion between periodontitis and rheumatoid arthritis using multivariate regression and chi square tests. they found that periodontitis was more prevalent in patients with rheumatoid arthritis than in the control group and that patients who were seropositive for rheumatoid factor were more likely to have moderate to severe periodontitis than patients who were rf negative and also that patients who were positive for anti-cyclic citrullinated peptide antibodies were more likely to have moderate to severe periodontitis (redman et al. ) . paju and scannapeico investigated the association among oral biofi lms, periodontitis and pulmonary infections. they noted that periodontitis seems to infl uence the incidence of pulmonary infections, particularly nosocomial pneumonia in high-risk subjects and that improved oral hygiene has been shown to reduce the occurrence of nosocomial pneumonia. they found that oral colonization by potential respiratory pathogens, for possibly fostered by periodontitis and possibly by bacteria specifi c to the oral cavity contribute to pulmonary infections (paju and scannapeico ) . the implications for these fi ndings are profound. professionally, they suggest that managing patients with chronic illness and periodontal disease will require teamwork and a deeper knowledge base for dentists and for physicians (mealey and rose ) . dentists will need to be alert for early signs of chronic illness among their patients and physicians will need to be alert for signs of dental disease. both will need to consider wider treatment options than their specialty indicates. dentistry and medicine have operated as professional silos in the past. the relationship between dental disease and chronic medical conditions suggests that continued separation is detrimental to patient centered care. beyond treatment implications, there are extremely important health policy concerns. if treatment of periodontitis and other dental problems leads to reduced incidence of chronic illness, fewer complications from chronic diseases and reduced morbidity among chronically ill patients, increased access to dental services could signifi cantly reduce health care costs. the diseases associated with periodontitis are among the most common illnesses, the fastest growing and the most expensive diseases that we treat. a recent robert wood johnson report notes that approximately million americans have one or more chronic conditions, that the number of people with chronic conditions is expected to increase by % per year for the foreseeable future and that the most common chronic conditions include hypertension, disorders of lipid metabolism, upper respiratory disease, joint disorders, heart disease, diabetes, cardiovascular disorders, asthma and chronic respiratory infections (anderson ) (see fig . . ). one in four americans has multiple chronic conditions. ninety-one percent of adults aged and older have at least one chronic condition and % have two or more of them (anderson ) . people with chronic conditions account for % of all healthcare spending. seventy eight percent of private health insurance spending is attributable to the % of privately insured persons with chronic conditions. seventy three percent of healthcare spending for the uninsured is for care received by the one third of uninsured people who have chronic conditions. seventy nine percent of medicaid spending goes to care for the % of non-institutionalized benefi ciaries who have chronic conditions (anderson ) (see fig. . ). further, health care spending increases with the number of chronic conditions (anderson ) (see fig. . ). more than three fi fths of healthcare spending (two thirds of medicare spending) goes to care for people with multiple chronic conditions. those with multiple chronic conditions are more likely to be hospitalized, fi ll more prescriptions, and have more physician visits (anderson ) . in the american diabetes association estimated direct medical expenditures for diabetes at $ . billion: $ . billion for diabetes care, $ . billion for chronic complications and $ . billion for excess prevalence of general medical conditions. approximately % of direct medical expenditures were incurred by people over . indirect expenditures included lost workdays, restricted productivity mortality and permanent disability -a total of $ . billion. all told, diabetes was found to be responsible for $ billion of $ billion in total expenditures. per capita medical expenditures totaled $ , annually for people with diabetes and $ for people without diabetes (hogan et al. ) . more recently, dall and colleagues estimated that the us national economic burden of prediabetes and diabetes had reached $ billion in , $ million in higher medical costs and $ billion in reduced productivity. annual cost per case was estimated at $ , for undiagnosed diabetes and , for type diabetes (dall et al. ) . the costs of caring for people with diabetes have risen both because the numbers of diabetics has been increasing and because the per capita costs of care have increased. the number of diabetics increased from . million on to . million in (ashkenazy and abrahamson ) . a recent report by the unitedhealth group center for health reform & modernization provides a dire estimation -that more than % of adult americans could have diabetes ( %) or prediabetes ( %) by at a cost of $ . trillion over the decade. this compares with current estimates of % of the population with diabetes and % with prediabetes, or %. these estimates conclude that diabetes and prediabetes will account for % of total healthcare spending in at an annual cost of $ billion, up from an estimated $ billion in (unitedhealth center for health reform and modernization ) . average annual spending over the next decade by payer type is $ billion for private health insurance, $ billion for medicare, $ billion for medicaid and $ . billion for the uninsured. what about cardiovascular disease and rheumatoid arthritis? among the top ten health conditions requiring treatment for medicare benefi ciaries in approximately % of benefi ciaries suffered from hypertension, % from heart conditions, % had hyperlipidemia % had copd, % had osteoarthritis and % had diabetes (thorpe et al. ) . the american heart association estimates the cost of cardiovascular disease and stroke to be $ billion in direct expenditures and $ . billion for productivity losses due to morbidity and $ . billion in lost productivity due to mortality (present value of lost wages at %) (lloyd- ) . the centers for disease control estimates that during - million americans had selfreported doctor diagnosed arthritis, million of them with activity limitations (cheng et al. ) . cisternas and colleagues estimated that total expenditures by us adults with arthritis increased from $ billion in to $ billion in . most of the increase was attributable to people who had co-occurring chronic conditions (cisternas et al. ) . the cisternas study appears to aggregate all medical care expenditures by people with arthritis (which would include expenditures to treat diabetes and cardiovascular disease). an earlier cdc study focused on the direct and indirect costs in attributable to arthritis that estimated $ . billion in direct costs (medical expenditures) and $ billion in indirect costs (lost earnings) (yelin et al. ) . in short, current cost estimates for direct health care expenditures (excluding productivity losses) related to diabetes are approximately $ billion, for cardiovascular treatment, $ billion, and for rheumatoid arthritis, approximately $ billion (estimating that the $ . billion in costs have grown approximately % per year), a total of $ billion of the $ . trillion that will be spent in the us in . moreover, given current growth in the prevalence of diabetes, the unitedhealth estimate of $ million in spending for diabetes alone is not unreasonable. if health care costs attributable to diabetes, cardiovascular disease and rheumatoid arthritis only increase by % over the next decade (even given added demand produced by the aging baby boomer population), annual costs of these chronic diseases will exceed $ . trillion in . if we use the unitedhealth estimates for the proportions of diabetes costs paid by private insurance ( %), medicare ( %), medicaid ( %) and the uninsured ( %) and estimate total costs based on the studies projecting a % increase in years and a % increase in years we can obtain an estimate of future costs for treating diabetes, cardiovascular disease and arthritis. table . set forth below, summarizes these cost estimates. by medicare costs for these chronic illnesses would be approximately $ billion. the estimated costs to medicaid will be approximately $ billion. the costs for the uninsured will be approximately $ billion. any intervention that has the potential to substantially reduce these costs will produce meaningful results. unfortunately, even though there had been a substantial numbers of studies that show relationships between dental disease and chronic illness that are have been very few studies that actually test whether improved dental treatment reduces the incidence of chronic illness and complications due to chronic illness. the potential for large health care cost savings through an active and aggressive program of dental care is so large that such studies are clearly indicated. suppose, for example, that % of all medical care costs required to treat diabetes, cardiovascular disease and arthritis could be avoided through an active aggressive program of dental care. what this would mean is that in private health insurers could see a $ billion reduction in healthcare costs, medicare would see a $ . billion reduction and medicaid pay $ . billion reduction. recent health reform has provided for the issuance of health insurance to the uninsured by state exchanges. aggressive dental care that saved % of costs attributable to diabetes, cardiovascular disease and arthritis could save the exchanges $ billion per year. and, if greater proportions of costs can be saved or if the estimates of costs are low, potential benefi ts will be even larger. once again, it would be important to know whether aggressive dental care could produce such savings and how much. ide and colleagues found that people who were treated for periodontitis incurred % higher health care costs than those who were free of periodontal disease (ide et al. ) . similarly, albert, et al., found medical costs associated with diabetes, cardiovascular disease and cerebrovascular disease were signifi cantly higher for enrollees who were treated for periodontitis than for other dental conditions (albert et al. ) . additional studies of this nature would be important to support a measured approach to expanding dental coverage. so what do we mean by an aggressive dental treatment plan? suppose we were to provide dental insurance to all medicare benefi ciaries at the level of current private dental insurance coverage and strongly encourage benefi ciaries to receive dental treatment. suppose we were to provide for medicaid payment for all benefi ciaries at the level of current private dental insurance coverage. suppose health care insurers provided dental coverage in order to reduce their costs and that such coverage was consistent with current private dental insurance coverage. suppose health insurance companies, understanding the benefi ts from dental care, were to require their private employer customers to cover the costs of dental care. how much would all of this cost? how would it compare to the benefi ts that may be available? in order to estimate the potential costs of providing enhanced coverage for dental care we start use the cms estimates of national health care spending for dental services and statistical abstract of the us estimates for medicare enrollment, medicaid enrollment, private health insurance enrollment and uninsured persons. based on the estimate that half of private employers with health insurance provided dental insurance coverage we estimate that of the private health insurance enrollment one half would have dental insurance coverage and one half would not. table . sets forth the national health care expenditures for dental services in millions and enrollment in private dental plans, medicare, medicaid, the uninsured without health insurance and dental insurance, the uninsured with health insurance and dual eligibles. from this we derive a cost per enrollee for private dental insurance, medicare dental benefi ts and medicaid dental benefi ts. in order to estimate the annual cost of providing full dental coverage to medicare benefi ciaries we subtracted dual eligibles (who receive some dental insurance) from total medicare enrollees to determine the number of persons who would need coverage. in our example there were million medicare benefi ciaries including million dual eligibles. accordingly, the estimates would cover the million medicare benefi ciaries that are not dual eligible at a cost equal to the per capita cost of private dental insurance ($ . ) less amounts that medicare is already paying for dental services ($ . per person). the result provides an estimate of the cost of covering all medicare benefi ciaries for dental services at a level equivalent to private health insurance. using the example the cost of providing full dental insurance coverage to medicare benefi ciaries would have been $ . billion. in addition, we used the cms national health expenditure fi gures to determine administrative costs for private health insurance, medicare and medicaid as a percentage of program expenditures for medical care. we found that the administrative costs of the medicare program were . % on average for - . in order to fully estimate the cost of medicare dental coverage we added . % to the cost health insurers will be in the same position as medicare and medicaid regarding dental coverage. if quality dental coverage saves health care costs attributable to diabetes, cardiovascular disease and rheumatoid arthritis then the exchanges will have an incentive to provide quality dental coverage to reduce costs. accordingly, we estimated the cost of providing dental coverage equivalent to private dental insurance coverage through the exchanges. again we assume that the costs of such coverage will be equivalent to the number of uninsured persons multiplied by the annual per capita cost of coverage. for the example, this would refl ect coverage for million people at $ . per person, a total of $ . billion. with administrative costs, the cost of providing dental insurance coverage to the uninsured at a level equivalent to private dental coverage would be $ . billion. finally, given the evidence that improved dental care has the potential to reduce health care costs private health insurers may wish to expand health insurance to cover dental care. here, we estimate the cost of providing dental insurance to the % of the workforce whose employers currently do not provide dental insurance benefi ts. once again, we multiply the number of covered lives by the estimated annual per capita cost. for the example we estimate million adults will receive dental coverage at $ per person: $ billion for dental services and $ . billion for administrative costs or a total of $ . billion. of course, as noted a number of times above, these estimates are based on providing full "universal" dental insurance coverage at levels equivalent to current benefi t levels for private dental insurance. it may be that an appropriate package of dental services that deals specifi cally with periodontitis can be provided for less than the full cost of private dental insurance. once again, further research should provide better information. the health reform law does not attempt to provide coverage to all million people without health insurance. estimates are that only million people will be covered by the bill. even though this is the case we prepare our estimates using all million uninsured americans. indeed, the failure of % of employers to cover dental services may well constitute a classic externality in the market for health insurance. internalizing this externality may well provide better effi ciency. it is also possible that dental care for persons with greater incidence of chronic illness as is the case with medicare benefi ciaries may require even higher levels of spending per benefi ciary. again, it would be good to know scientifi cally if this is the case. as noted in sect. above, costs for diabetes, cardiovascular disease and arthritis will be $ billion for private health insurance, $ billion for medicare, $ billion for medicaid and $ billion for the uninsured. costs of providing "full" dental coverage will be $ . billion for medicare, $ . billion for medicaid, $ . billion for the uninsured and $ . billion for private health insurance. given this, if . % or more of the medicare costs can be "saved" through improved dental care, medicaid dental insurance will pay for itself and will provide a positive return on investment. see table . . similarly, private health insurers could justify providing dental insurance coverage to employees who do not have it so long as they spend . % or more of their chronic care costs for diabetes, cardiovascular disease and arthritis. on the other hand, it would appear that medicaid expansion would require cost savings of approximately % and that health care insurance coverage of the uninsured would require savings of approximately % in order to justify coverage. while it is possible, it may not be likely that full dental coverage would be justifi ed for these programs. of course, these estimates do not consider indirect costs in the form of lost wages or premature death. these costs are externalities to the health insurance programs. to the extent that they represent a social benefi t that a national dental insurance program might internalize, it would be appropriate to consider their impact in the cost-benefi t analysis. in any event, better understanding of the potential for deriving savings in health insurance costs related to chronic diseases like diabetes, cardiovascular disease and arthritis would be crucial to any determination whether to expand insurance coverage for dental care. heretofore the case for expanding medicare coverage to include dental care has taken the form of "benefi t" to patients rather than benefi t to health insurance programs and society and has been cast in emotional and political terms. for example, oral health america grades "america's commitment to providing oral health access to the elderly" (oral health america ) . in truth, there is no american commitment to providing oral health access to any age group, much less the elderly. rubenstein notes that "at least one commentator has suggested that the dental profession should join with senior citizen groups when the time is right to ask congress to expand medicare to cover oral health" (rubenstein ) . rubenstein emphasizes that "calls for action" are "mere words" unless they are accompanied by political actions that health policy professionals and the dental profession must help promote (rubenstein ) . another commentator has suggested that "as soon as the debate over medicare prescription drug coverage and, the debate to provide dental care coverage for the elderly may soon begin" (manski ) . rubenstein, again suggests that "the dental community must convince americans, and particularly aging boomers, that oral health is integral to all health, and for that reason, retiree dental benefi ts are an important issue". in truth, a decade of defi cit spending and public distaste for out of control program costs in the medicare and medicaid programs as well as the unpopularity of the process that was used to provide medicare prescription drug coverage (with perceived abuses by the health insurance and drug lobbies) and national health reform makes it unlikely that the public would be willing to approve expansions in insurance coverage for dental care "for its own sake" or "as the right thing" or to "benefi t seniors." what this political climate has produced is an arena in which a good idea that could provide appropriate return on investment for society might well be rejected out of hand based on political history of health insurance coverage. as a result, it is incumbent on policymakers, medical and dental research scientists and health economists to investigate and confi rm the potential savings that expansion of dental insurance coverage has the potential to produce and to develop hard evidence regarding potential costs of the expansion prior to, not as a part of, political efforts aimed at dental coverage expansion. a responsible, well informed effort to expand dental coverage may well go far to restore public confi dence in the health policy process. joseph kilsdonk and kelly boggs the adage of "putting your money where your mouth is" is often referenced when being challenged about public statements or claims. in this instance, we use it literally. in health care costs in us were $ . trillion. there have been numerous reports on health disparities, the burden of chronic diseases, increasing healthcare costs and the need for change. long-term economic benefi ts associated with the cost of care are dependent upon integrating oral health with medicine. this is particularly true as it relates to the management of those conditions which impact the economics of healthcare the most. as examples, % of medicare costs and % of medicaid costs are in managing chronic health conditions (partnership for solutions national program offi ce ) . more than % of the u.s. population has one or more chronic condition (cartwright-smith ) and in , % of medicare spending was on patients with fi ve or more chronic diseases (swartz ) . effective management of health care resources and information are critical to the economic well-being of our healthcare system. we can no longer afford to manage care in isolation. integration of care between medicine and dentistry holds much promise in terms of reducing the cost of care and an integrated medical-dental electronic healthcare record (iehr) is the vehicle that will lead to downstream cost savings. in the united states the center for medicare & medicaid services (cms) has conducted demonstration projects around chronic disease management. section of the benefi ts improvement and protection act of mandated cms to conduct a disease management demonstration project. april , , as an effort to reduce the cost of care and improve quality associated with chronic diseases, cms partnered with ten premier health systems to effectively manage chronic diseases in a medicare physician group practice demonstration (pgp). it was the fi rst pay-for-performance initiative for physicians under the medicare program (center for medicare and medicaid services ) . it involved giving additional payments to providers based on practice effi ciency and improved management of chronically ill patients. participants included ten multispecialty group practices nationwide, with a total of more than , physicians, who care for more than , medicare benefi ciaries (frieden ) . the chronic diseases that were targeted were based on occurrence in the population and included diabetes, heart failure, coronary artery disease, and hypertension (frieden under the pgp, physician groups continued to be paid under regular medicare fee schedules and had the opportunity to share in savings from enhancements in patient care management. physician groups could earn performance payments which were divided between cost effi ciency for generating savings and performance on quality measures phased in during the demonstration as follows: year , measures, year , measures and years and having quality measures. for each of the years only the university of michigan faculty group practice and marshfi eld clinic, earned performance payments for improving the quality and cost effi ciency of care. a large part of the success of this project was attributed to being able to extract, evaluate, and monitor key clinical data associated with the specifi c disease and to manage that data through an electronic health record (table . ). during the third year of the demonstration project marshfi eld clinic, using a robust electronic health record succeeded in saving cms $ million dollars; that's one clinic system in year. as a result of such demonstration projects and as of this writing, cms is looking to establish accountable care organization's as the medical front runners to new care delivery methods for quality and cost control. accountable care organization (aco) is a term used to describe partnerships between healthcare providers to establish accountability and improved outcomes for the patients. in a cms workshop on october , , don berwick, the administrator of cms, stated "an aco will put the patient and family at the center of all its activities…" an emerging model of an aco is the patient-centered medical home (pcmh). pcmh is at the center of many demonstration projects. acos were derived from studies piloted by cms. since funds provided by cms, do not cover routine dental care as part of the patient management or quality and cost objectives cms aco studies are limited if they become models for the pcmh, due to the exclusion of dental. more recently, organizations representing the major primary care specialtiesthe american academy of family practice, the american academy of pediatrics, the american osteopathic association, and the american college of physicianshave worked together to develop and endorse the concept of the "patient-centered medical home," a practice model that would more effectively support the core functions of primary care and the management of chronic disease (fisher ) . in geisinger health system, kaiser permanente, mayo clinic, intermountain healthcare and group health cooperative announced they will be creating a project called the care connectivity consortium. this project is intended to exchange patient information. although progressive in their approach their project does not include dental. these benefi ts however, are yet to be adapted in the arena of oral health. as of this writing, dentistry remains largely separate from medical reimbursement mechanisms such as shared billing, integrated consults, diagnosis, shared problem lists, and government coverage. for example, cms does not cover routine dental care. dentistry is also working to establish its own "dental home" with patients. however to reap the economic benefi ts of integrated care, a primary care "medical-dental" home is what needs to be created. according to an institute of oral health report ( ) it is widely accepted across the dental profession that oral health has a direct impact on systemic health, and increasingly, medical and dental care providers are building to bridge relationships that create treatment solutions. the case for medical and dental professionals' comanaging patients has been suggested for almost the past century, in william gies reported that "the frequency of periodic examination gives dentists exceptional opportunity to note early signs of many types of illnesses outside the domain of dentistry" (gies ) . as described by dr. richard nagelberg, dds "the convergence of dental and medical care is underway. our patients will be the benefi ciaries of this trend. for too long, we have provided dental care in a bubble, practicing -to a large degree -apart from other health-care providers. even when we consulted with our medical colleagues, it was to fi nd out if premedication was necessary, get clearance for treatment of a medically compromised patient, or fi nd out the hba c level of a diabetic individual, rather than providing true patient co-management. we have made diagnoses and provided treatments without the benefi t of tests, reports, metrics, and other information that predict the likelihood of disease development and progression, as well as favorable treatment outcomes. we have practiced in this manner not due to negligence, but because of the limitations of tools that were available to us" (nagelberg ) . integrated medical/dental records need to be a tool in a providers' toolbox. in the case of marshfi eld clinic, dental was not included in their past cms demonstration project as dental is not a cms covered benefi t, and thus not part of the demonstration. however, as a leader in healthcare, the marshfi eld clinic recognizes the importance of data integration for both increased quality and cost savings. "marshfi eld clinic believes the best health care comes from an integrated dental/medical approach," said michael murphy, director, business development for cattails software. integration enhances communication between providers and can ultimately lead to better management of complex diseases with oral-systemic connection, avoidance of medical errors, and improved public health. while the cms pgp and other demonstration projects along with independent studies have shown to improve quality and reduce costs through integration, greater results may be afforded if studies are not done in isolation from dental data. in fact, if healthcare does not fi nd a way to manage the systemic nature of the pathogens known to the oral cavity the economic impact and cost savings around chronic disease management will hit a ceiling. the economic opportunity of having clinical data for integrated decision making is readily identifi ed by the insurance industry. the effective management of clinical data around chronic and systemic oral and medical disease as part of an iehr is the greatest healthcare cost savings opportunity associated with such a tool. the insurance industry sustains itself through risk management [obtaining best outcomes] using actuarial analysis [data] and controlling costs [reduction of costs] in order to ensure coverage [profi tability]. as such they have pursued the economic and outcome benefi ts of integrated medical -dental clinical decision making. as an example, in there was a study conducted by the university of michigan, commissioned by the blue cross blue shield of michigan foundation ( ) , the study included , blue cross blue shield of michigan members diagnosed with diabetes who had access to dental care, and had continuous coverage for at least year. with regular periodontal care, it was observed diabetes related medical costs were reduced by %. when compounding chronic health complications were also examined, the study showed a % reduction in cost related to the treatment of cardiovascular disease in patients with diabetes and heart disease. a % reduction in cost related to treatment of kidney disease for patients with diabetes and kidney disease. and a % reduction in costs related to treating congestive heart failure for patients with diabetes and congestive heart failure. according to a joint statement by lead researchers, and blue cross blue shield of michigan executives, "our results are consistent with an emerging body of evidence that periodontal disease…it addresses quality of care and health care costs for all michigan residents." also, at the institute for oral health conference in november joseph errante, d.d.s., vice president, blue cross blue shield of ma reported that blue cross blue shield of massachusetts claims data showed medical costs for diabetics who accessed dental care for prevention and periodontal services averaged $ /month, while medical costs for diabetics who didn't get dental care were about $ /month (errante ) . similarly insured individuals with cardiovascular diseases who accessed dental care had lower medical costs, $ /month lower than people who did not seek dental treatment (errante ) . the cost is $ less per visit for those diabetics who accessed prevention and periodontal services. those savings could be translated into access to care or additional benefi ts for more individuals. in the case of neonatal health there is similar research. over % of all births in the u.s. are delivered preterm, with many infants at risk of birth defects ( martin et al. ) . according to a january statement issued by cigna, announcing their cigna oral health maternity program, "the program was launched in response to mounting research indicating an increased probability of preterm birth for those with gum disease. these research-based, value-added programs are designed to help improve outcomes and reduce expense" (cigna ) . the program was initially designed to offer extended dental benefi ts free of charge to members who were expecting mothers, citing "research supporting the negative and costly impact periodontal disease has on both mother and baby." according to research cited by cigna, expecting mothers with chronic periodontal disease during the second trimester are seven times more likely to deliver preterm (before th week), and the costs associated with treating premature newborns is an average of times more during their fi rst year, and premature newborns have dramatically more healthcare challenges throughout their life. cigna also cited the correlation between periodontal disease and low birth weight, pre-eclampsia, gestational diabetes as additional rationale to support extended dental benefi ts to expecting mothers. six months later cigna initiated well aware for better health, an extended benefi ts free of charge program for diabetic and cardiovascular disease patients aimed at "turning evidence into action by enhancing dental benefi ts for participants in disease management" programs. it is interesting to note, not only does cigna offer extended dental benefi t to targeted groups, they also reimburse members for any out-of-pocket expenses associated to their dental care (co-pays, etc.) in , columbia university researchers conducted a -year retrospective study of , aetna ppo members with continuous medical and dental insurance, exhibiting one of three chronic conditions (diabetes mellitus, coronary artery disease, and cerebrovascular disease) (aetna ) . researchers found members who received periodontal treatments incurred higher initial per member per month medical costs, but ultimately achieved signifi cantly lower health screening (episode risk group/erg) risk scores than peers receiving little or no dental care. convinced by the data and understanding lower risk scores ultimately leads to healthier people and cost savings, aetna initiated the dental/medical integration (dmi) program in . aetna's dmi program offers enhanced benefi ts in the form of free-of-charge extended benefi t dental care to aetna's . million indemnity, ppo and managed choice medical plan members, specifi cally targeting members deemed at-risk, including those who are pregnant, diabetic, and/or have cardiovascular disease and have not been to a dentist in year as a result of various outreach methods during the pilot, % of at-risk members who had not been to a dentist in the previous months, sought dental care (aetna ) . "the fi ndings from this latest study we conducted continue to show that members with certain conditions who are engaged in seeking preventive care, such as regular dental visits, can improve their overall health and quality of life," said alan hirschberg, head of aetna dental (aetna ) . delta dental of wisconsin understands the connection between oral and systemic health and has created a program that is designed to offer members with certain chronic health conditions the opportunity to gain additional benefi ts. more than , groups now offer delta dental of wisconsin's evidence-based integrated care plan (ebicp) option (delta dental of wisconsin ) . ebicp provides expanded benefi ts for persons with diseases and medical conditions that have oral health implications. these benefi ts include increased frequency of cleanings and/or applications of topical fl uoride. they address the unique oral health challenges faced by persons with these conditions, and can also play an important role in the management of an individual's medical condition. ebicp offers additional cleanings and topical fl uoride application for persons who are undergoing cancer treatment involving radiation and/or chemotherapy, persons with prior surgical or nonsurgical treatment of periodontal disease and persons with suppressed immune systems. the ebic offers additional cleanings for persons with diabetes and those with risk factors for ie, persons with kidney failure or who are on dialysis and for women who are pregnant. the iehr provides the insurance industry in partnership with the healthcare industry an integrated tool to facilitate these health and subsequently economic outcomes across medicine and dentistry. in addition to the anticipated savings through better outcomes using integrated clinical data, an example of a positive economic outcome associated with an integrated record as related to increased effi ciency and patient safety is found in the united states veterans administration (va) hospitals and clinics. the va is one of the few institutions that have implemented the shared electronic medical-dental record successfully. the va has the ability to be the "one stop shop" for their patients. an april press release published on the department of veterans affairs website highlighted the success of va's health information technology in terms of cost reductions and "improvements in quality, safety, and patient satisfaction" (department of veterans affairs ) . the press release spotlighted a recent study conducted by the public health journal, health affairs, which focused on va's health it investment from to . the study confi rmed that while va has spent $ billion on their technology initiative, a conservative estimate of cost savings was more than $ billion. after subtracting the expense of the it investment, there was a net savings of $ billion for the va during the years covered by the study (mcbride ) . furthermore, the study estimated that "more than percent of the savings were due to eliminating duplicated tests and reducing medical errors. the rest of the savings came from lower operating expenses and reduced workload." independent studies show that the va system does better on many measures, especially preventive services and chronic care, than the private sector and medicare. va offi cials say "its [integrated] technology has helped cut down hospitalizations and helped patients live longer" (zhang ) . recently, the journal of obstetrics and gynecology reported on a tragic loss of life due to the systemic nature of oral health. a study found oral bacteria called fusobacterium nucleatum was the likely culprit in infecting a -year-old woman's fetus through her bloodstream (carroll ) . the doctors determined that the same strain of oral bacteria found in the woman's mouth was in the deceased baby's stomach and lungs. integrated records would provide critical data to the obstetrician including oral health issues and when the patient had her last dental exam. how does one measure the economic impact of a life not lived and another derailed by such tragedy? in a randomized controlled study, lopez et al. ( ) determined that periodontal therapy provided during pregnancy to women with periodontitis or gingivitis reduced the incidence of preterm and of low birth weight. the institute of medicine and national academies estimate that preterm births cost society at least $ billion annually . data integration of the iehr enables the effective management between the dentist and obstetrician to ensure proper periodontal therapy has been provided during pregnancy. such management based on the lopez et al. study, will have direct impact in reducing the prevalence per preterm births leading to reduced health care costs. there have also been studies indicating a correlation between poorer oral hygiene or defi cient denture hygiene and pneumonia or respiratory tract infection among elderly people in nursing homes or hospitals (rosenblum ; ghezzi and ship ; scannapieco ) . one such study of elderly persons in two nursing homes in japan (adachi et al. ) concluded that "the number of bacteria silently aspirating into the lower respiratory tract was lower in the group who received professional oral care, which resulted in less fatal aspiration pneumonia in that group." over the month period of the study, of the patients receiving professional oral care, % died of pneumonia versus . % of the patients that died of the same cause who maintained their own oral hygiene. lack of access is certainly a key factor to consider. however, lack of available data respective to the interrelationship between oral health and systemic health also contributed to the apathy in these cases. as identifi ed above, complications are correlated to cost. as conditions compound, costs go up. marshfi eld clinic, as part of their iehr is creating a shared problem list that identifi es both oral and medical conditions and history to recent visits and medication lists for monitoring at point of care [be it a medical or dental visit], such cross access to clinical data and care management milestones serves as a tool to prevent conditions from compounding and escalating costs such as those described above. several other areas of economic impact will be seen as iehr's become broadly deployed. some of these are listed as follows: medication management. a great deal of provider and allied support time is • spent obtaining medication information between dentistry and medicine [and vice versa] including current medications, contraindications, tolerances, etc. marshfi eld clinic cattails software has created a dashboard that readily identifi es this for both the medical and dental providers. not is time saved but chances for complications or escalation of conditions is reduced [both of which impact cost]. for example an integrated record allows medical providers treating respiratory infections to include or exclude oral fl ora as the possible source of the infection which would lead to more knowledgeable prescribing decision on the antibiotic used. coordination of care has a direct impact on cost for the system and the patient. • for example, in . % of the us population aged years and older that was diagnosed diabetes had been to the dentist in the past year (healthy people ( )). the us government's program healthy people includes an initiative to increase the proportion of people with diagnosed diabetes who have at least an annual dental examination. the american diabetes association recommends that diabetic patients be seen semi-annually and more if bleeding gums or other oral issues are present. the american diabetes association also recommends the consultation between the dentist and doctor to decide about possible adjustments to diabetes medicines, or to decide if an antibiotic is needed before surgery to prevent infection. the target from the healthy people is a % improvement at . %. integrated medical/dental records could allow for the coordination of efforts between providers to include communication of treatment plan and services leading to quicker resolution, increased patient compliance, and less patient time away from work or home and potentially less travel. similarly, integrated records also create a platform to integrate clinical appointing • between medicine and dentistry. as such, combative patients or severely disabled patients needing anesthesia in order for care to be delivered can be treated with one hospital sedation vs. multiple sedations. family health center of marshfi eld, inc. (fhc) dental clinics shares an iehr with marshfi eld clinic and uses it integrated scheduling feature to complete dental care, lab work, ent care, woman's health, preventive studies, all in one visit. follow up care management can be more focused and coordinated. for example, • without the knowledge or dental conditions, medical providers could spend months attempting to control diabetes with periodontal disease. however, with access to an iehr, the practitioner or allied care manager can determine patient's oral health status immediately to determine possible infl uence of periodontal disease. similarly an iehr with a shared patient data dashboard brings to light history • and physical examination data without having to have patients be the historian to their physician on their last dental visit or for the dentist to have to rely on the patient's recall of medications or medical diagnosis. for example, if an integrated record saved providers min per hour of patient care, that would be min per day. imagine giving a physician or dentist min more a day. in a capitated system, this allows for more patients to be seen in a day for roughly the same amount of expenditure. in a production based clinic this allows more patients to be seen and more charges per day. in either case, the investment into informatics is covered. in an underserved area, more patients get care quicker, which creates the opportunity for quicker resolution, which can lead to a healthier society, which in turn may lead them back to a productive livelihood sooner. an iehr results in one system for acquisition, orientation, training and support. • pc based owners who also own a mac and mac owners who also have to operate a pc can relate. need we say more? imagine if your pc function just like a mac [or your mac function just a pc]. no cross learning of software quirks. not having to purchase two separate units to begin with. reduced costs, increased space. not having to jump from one computer to the other computer to get data from one data from another to create a report. not having to call two separate computer companies for service or updates. third party coordination. having an iehr creates a platform for interfacing • with third party payers. a common system and language for timely reimbursement. in part, the result of an iehr is driving the diagnostic coding for dentistry. such an integrated interface provides a tool to bridge with healthcare payors that historically kept payment as segregated as the oral and medical health professions. the iehr overcomes that limitation. timely payment, consolidation of payment, expansion of covered patient and provider benefi ts based on clinical integration, and a viable system for interfacing are all potential economic benefi ts of iehr clinical data. the iehr creates new horizons for research that will lead to cost saving discov-• eries. as example, knowing the benefi ts of research, marshfi eld clinic research foundation (mcrf) has created an oral and systemic health research project (oshrp). the creation of oshrp, led by dr. murray brilliant, will allow mcrf to capitalize on its existing and growing strengths in the areas of complex disease interactions and personalized health care (phc) to advance oral health and the health of the rest of the body. the oshrp has three specifi c goals: understand the connections between oral and systemic health (diabetes, heart disease, pre-term births) understand the causes of oral diseases and determine the effect of genetics, diet, water source (well/city + fl uoridation) and microbiome. understand how improving oral health aids systemic health (comparative effectiveness) and bring personalized health care (phc) to the dental arena. the oshrp research resource will be unique in the nation. as mcrf has done • with other projects, it will share this resource with qualifi ed investigators at other academic institutions both within and outside of wisconsin. oshrp will advance scientifi c knowledge, improve healthcare and prevention, reduce the cost of oral healthcare, and create new economic opportunities. such knowledge will have a direct economic impact on the cost of care and care management. the iehr creates an ability to have an integrated patient portal to comprehen-• sively maintain their health. portals are becoming more and more popular in the healthcare industry as a means to helping maintain compliance with care management recommendations and preventative procedures. portals provide patents a tool to stay up to date on their care and recommendations. portals can take iehr clinical data, adapt it through programming, and provide creative visual reinforcement for patients as they monitor their health status. the more patients engage in owning their health status, the more preventative services are followed through with. the more medicine and dentistry can leverage the prevention potential [which insurance companies have come to realize] the more likely costly conditions can be avoided. the link between oral health and systemic health is well documented. the separation of dental and medical is not a sustainable model in modern healthcare delivery. a new model of integrated care is necessary. aristotle said, "the whole is greater than the sum of its parts." increased access to combined medical and dental histories and diagnosis at the providers' fi ngertips makes vital information available. shared diagnosis between physicians and dentists could aid in formulating interventions and to accelerate decision making abilities by allowing for prioritizing of medical/ dental procedures. clinical management and treatment of the patient would be expedited with immediate access to both records. quality could be improved through a complete picture of the patient through the dashboard. all of which have a direct or indirect economic benefi t. the iehr will be the tool that facilitates such delivery and the studies and scenarios described in these pages point to signifi cant economic benefi ts to patients, payors, and providers. if increased access, multi-provider monitoring, shared problems lists with enhanced decision making abilities from iehr could reduce healthcare costs. the greatest cost reduction will be with using the iehr to manage chronic disease. a combined dental-medical electronic record with a shared data informatics platform is most likely to yield the best long-term economic solution while maintaining or enhancing positive patient outcomes. this section reveals viewpoints from a variety of medical and dental providers. one section focuses on optimal use of ophthalmic imaging, which should show how that the challenges of clinical data integration go beyond those encountered in the effort to bring oral health and systemic health together. wendy e. mouradian , suzanne boulter , paul casamassimo , and valerie j. harvey powell oral health is an important but often neglected part of overall health. historically separate systems of education, financing and practice in medicine and dentistry fuel this neglect, contributing to poorer health outcomes for vulnerable populations such as children, while increasing costs and chances for medical error for all patients. advances in understanding the impact of oral health on children's overall health, changing disease patterns and demographic trends strengthen the mandate for greater integration of oral and overall healthcare, as reviewed in two recent institute of medicine reports (iom a, b ) . the pediatric population could realize substantial benefit from oral disease prevention strategies under a coordinated system of care enhanced by integrated electronic health records (ehr). this approach would benefit all children but especially young children and those from low socioeconomic, minority and other disadvantaged groups who are at higher risk for oral disease and difficulties accessing dental care. this section focuses on the pediatric population and the need for close collaboration of pediatric medical and dental providers. first we consider how a child's developmental position and their parents' level of understanding might affect oral health outcomes. next we address the importance of children's oral health and the urgency of seizing missed opportunities to prevent disease. we then briefl y outlines some steps to preventing early childhood oral disease utilizing some of the many health providers that interact with families. finally we examine one pediatric hospital's approach to choosing an integrated ehr technology. children have unique characteristics which distinguish their needs from those of adults. children's developmental immaturities may increase their risks for poor oral health outcomes ( fig. all children, but especially young children, are limited in their ability to care for their own health and must depend upon adults. a child's parent/caregiver may also lack basic oral health knowledge and an awareness of their child's oral health needs, and/or suffer from poor oral health themselves. low oral health literacy is prevalent among patients and health professionals alike in america; individuals of low socioeconomic status or from ethnically diverse backgrounds may be at particular risk for low oral health literacy (iom a ) . without appropriate education, a parent…. may not correctly interpret a child's symptoms or signs of oral disease • may not know that caries is an infectious disease that can be spread to a child by • sharing spoons, for example, may not know the potential value of chewing gum with xylitol, • may not fully grasp the importance of good oral health hygiene habits, • may not grasp the consequences of a child consuming quantities of sugared • foods or beverages, may have diffi culty controlling the child's consumption of sugared foods or bev-• erages in or out of the home, may not realize the consequences of chronic use of sugared medications, • may not know the potential for systemic spread of disease from a toothache, or • for liver damage due to overuse of acetaminophen or other analgesics, may not grasp the long-term consequences of early childhood caries, • may live in a community without fl uoride in the tap water and not know about • alternative sources of fl uoride, may overlook oral health due to the stress of living in poverty, • may be fearful of dentists or oral health care due to their own experiences, • may have diffi culty locating a dental provider accepting public insurance, or • have other problems navigating the health care system. parents in turn depend on access to medical and dental providers with current understanding of the most effective ways to prevent caries and promote the child's oral and overall health. an important element in helping families is the provision of culturally-sensitive care to a diverse population. children are the most diverse segment of the population with % from minority backgrounds compared with % of the overall population (us census bureau ) . the separation of medical and dental systems and the lack of shared information can create additional barriers for families, especially for those with low health literacy or facing linguistic or cultural barriers. all pediatric health professionals have increased ethical and legal responsibilities to promote children's health, including advocacy for them at the system level (mouradian ) . although many factors can infl uence children's oral health outcomes, caries is largely a preventable disease. despite this, national trends and other data on broader considerations of medical and dental data integration children's oral health attest to this persistent national problem ) . some important facts include the following…. caries is the most prevalent chronic disease of childhood, • caries is a preventable disease unlike many chronic diseases of childhood, • yet according to (nicdr ) % of children - have had dental caries in • their primary teeth; % of children - have untreated dental caries. further, " % of children - have had dental caries in their permanent teeth; % of children - have untreated decay." overall "[c]hildren - have an average of . decayed primary teeth and . decayed primary surfaces," the latest epidemiologic evidence shows increasing rates of caries for young-• est children, reverse from the healthy people goal of decreasing caries. according to (nicdr ), overall "dental caries in the baby teeth of children - declined from the early s until the mid s. from the mid s until the most recent ( ) ( ) ( ) ( ) ( ) ( ) ) national health and nutrition examination survey, this trend has reversed: a small but signifi cant increase in primary decay was found. this trend reversal was more severe in younger children." disparities in children's oral health and access to care persist by age, income • level, race and ethnicity, and parental education level (edelstein and chinn ) . of concern, the latest increase was actually in a traditionally low-risk group of young children (dye and thornton-evans ) . the human and economic costs of early childhood caries are substantial • (casamassimo et al. ) . according to catalanotto ( ) , health consequences include… extreme pain, spread of infection/facial cellulitis, even death (otto - ) diffi culty chewing, poor weight gain falling off the growth curve (acs et al. - ) risk of dental decay in adult teeth (broadbent et al. - ; li and wang ) crooked bite (malocclusion) -children with special health care needs (cshcn) may be at higher risk for oral • disease and diffi culties accessing care. analyzing data from the national survey of children with special health care needs, (lewis ) found that "cshcn are more likely to be insured and to receive preventive dental care at equal or higher rates than children without special health care needs. nevertheless, cshcn, particularly lower income and severely affected, are more likely to report unmet dental care need compared with unaffected children." children who were both low-income and severely affected had . times the likelihood of unmet dental care needs, dental care is the highest unmet health care need of children; . million children • had unmet dental care needs because families could not afford care compared with . million with unmet medical needs for the same reasons (cdc ) , according to the national survey of children's health, children are . times as • likely to lack dental as medical insurance (lewis et al. ) , there is evidence that children who get referred to a dentist early may have lower • costs of care and disease. savage et al. ( ) reported that children "who had their fi rst preventive visit by age were more likely to have subsequent preventive visits but were not more likely to have subsequent restorative or emergency visits" and concluded that preschool "children who used early preventive dental care incurred fewer dentally related costs," ramos- gomez and shepherd ( • ) , in their "cost-effectiveness model for prevention of early childhood caries," conclude that preventive ecc interventions could reduce ecc by - % for a particularly vulnerable population of children, and that part of the costs of interventions will be offset by savings in treatment costs. as these facts convey, and the deaths of more than one child from consequences of untreated caries make painfully clear, there is an urgent need for more attention to the oral health needs of children. a more coordinated system for oral health care including integrated ehr would be an important advance. a glance at table . , an ideal model, reveals that intervention should begin before birth and that a range of medical and oral health professionals can contribute to the child's oral health. early intervention is necessary because of the transmissibility of cariogenic bacteria from mother/caregiver to infant, and importance of oral health practice in preventing disease. the following professionals may be involved: • pediatric medical provider family physician pediatrician pediatric nurse nurse practitioner in pediatric/family practice physician assistant in pediatric /family practice - other appropriate allied health professionals • the availability of some of these professionals can be affected socioeconomic status, health insurance, place of residence, or by a child's special health care need. one obvious limitation on developing a "relay" as in table . , with a "hand-off" from family care to obstetric care to pediatric care is the education of the medical providers. as part of pre-conception and perinatal healthcare, providers should address oral health, but may lack the knowledge to do so. additionally, as noted by ressler-maerlaender et al. ( ) , "some women may believe that they or their table . timeline of some oral health interventions to prevent early childhood caries (ecc) -birth to years age (marrs et al. ; lannon et al. ; han et al. ; ezer et al. ; aap ; mouradian et al. ) child's age intervening professional(s) planning conception, prenatal and perinatal family physician the physician and/or obstetric provider educates mother-to-be about good maternal oral hygiene and infant oral health issues, including transmissibility of caries. mother's dentist assesses and treats caries, gingivitis or other oral health problems and educates the mother-to-be obstetrician/nurse midwife obstetric nurse general dentist obstetric nurse obstetric nurse advises new mother to chew xylitol gum, limit salivary contact between mother and infant, and help child avoid sugar intake (exposure) while asleep and from common sugar sources (medicines, sugared water, bottle feeding on demand at night with fl uid other than water -following tooth eruption, certain foods), and to schedule dental exam at year age months pediatric medical provider first dental examination recommended by aapd when the fi rst tooth comes in, usually between to months pediatric/general dentist educate mother about optimal fl uoride levels . assess the woman's oral health status, oral health practices, and access to a dental home; . discuss with the woman how oral health affects general health; . offer referrals to oral health professionals for treatment; . educate the woman about oral health during pregnancy, including expected physiological changes in the mouth and interventions to prevent and relieve discomfort; and . educate the woman about diet and oral hygiene for infants and children and encourage breastfeeding a combination of anticipatory guidance, with continuity from prenatal and perinatal care to pediatric care, can help move infant oral health from "missed opportunities" to "seized opportunities." others who may be of assistance to families in closing these gaps are professionals at the women, infants and children's (wic) supplemental nutrition program, early head start/head start and neurodevelopmental/birth to three programs. together medical, dental and community professionals can help create a system of care to improve maternal and child oral health. for the envisioned model in table . to be realized, the mother requires access to a general dentist with accurate information on her oral health during pregnancy and on her infant's oral health, including the need for an early dental visit. the mother and child then need access to a pediatric medical provider who will provide oral health screening/counseling, and who will guide the family to establishing the child's dental home by age . success in dental referral requires access to a pediatric or general dentist willing and able to provide infant oral health. (dela cruz et al. ) , in a discussion of the referral process mentioned that among the factors in assessing the likelihood of a dental referral were the medical providers' "level of oral health knowledge, and their opinions about the importance of oral health and preventive dental care." since young children are much more likely to access medical than dental care, the medical provider plays an important role in promoting children's oral health. (catalanotto ) recommends, as part of a pediatric well child checkup: an oral screening examination, • a risk assessment, including assessment of the mother's/caregiver's oral health, • application of fl uoride varnish • anticipatory guidance (parental education) including dietary and oral hygiene • information, attempted referral to a dental home. • the aap recommends that child healthcare providers be trained to perform an oral health risk assessment and triage all infants and children beginning by months of age to identify known risk factors for early childhood caries (ecc). the oral health component of pediatric care is integrated into the aap's "recommendations for preventive pediatric health care (periodicity schedule)" (aap ) . to what extent are medical and dental and providers aware of recommendations for a fi rst dental visit for a child by age one, as recommended by the aap, the american academy of pediatric dentistry (aapd), and the american dental association? (wolfe et al. ) reported that % of licensed general dentists in iowa were familiar with the aapd age dental visit recommendation and that most obtained the information through continuing education; % believed that the fi rst dental visit should occur between and months of age. however, according to (caspary et al. ) , when pediatric medical residents were asked the age for the fi rst dental visit, the average response was . years, while % reported received no oral health training during residency. in a national survey of pediatricians ) reported that less than % of had received oral health education in medical school, residency, or continuing education. finally (ferullo et al. ) surveyed allopathic and osteopathic schools of medicine and found that . % reported offering less than h of oral health curriculum, while . % offered no curriculum at all. other workforce considerations relevant to preventing early childhood caries include the training of dentists in pediatric oral health (seale et al. ) , the number and diversity of the dental workforce, the number of pediatric dentists, and the use of alternative providers such as dental therapists, expanded function dental assistants and dental hygienists (mertz and mouradian ; nash ) . examples of integrated care models do exist, such as that presented by (heuer ) involving school-linked and school-based clinics with an "innovative health infrastructure." according to heuer, "neighborhood outreach action for health (noah)" is staffed by two nurse practitioners and a part-time physician to provide "primary medical services to more than , uninsured patients each year" in scottsdale, arizona. heuer counts caries among the "top ten" diagnoses every year. mabry and mosca ( ) described community public health training of dental hygiene students for children with neurodevelopmental/intellectual disabilities. they mentioned that the dental hygiene students had worked together with school nurses and "felt they had impacted the school nurses' knowledge of oral disease and care." the decision to acquire an integrated ehr as pediatric clinicians (both medical and dental) work more closely together, they require appropriate ehr systems that integrate a patient's medical and dental records. following is a set of local "best practices" from nationwide children's hospital in columbus, ohio, which may help other children's hospitals in planning acquisition of an integrated pediatric ehr system. integrated (medical-dental) ehr technologies are becoming more widely available outside the federal government sector (see integrated models e and e in fig. . ). nationwide children's 'drivers' for the acquisition process were, in : . minimize registration and dual databases . patient registration takes time and requiring both a stand-alone dental and a medical patient registration inhibits cost-effective fl ow of services. integration allows for the use of single demographics information for all clinics in the comprehensive care system serving the patient. clinicians always have an updated health history on patients, if they have been a patient of record. if not, and for a dental clinic that sees walk-ins, a brief "critical" dental health history can be completed on paper by a parent and scanned into the emr. in designing an integrated medical-dental record for patients of record, the system can sort essential health history elements into a brief focused dental history without the detail needed by other medical specialty clinics. kioskdriven electronic health histories for those children who are new to clinic similar to those used in airline travel could be considered if feasible in busy clinics. . for charting, no more key/mouse strokes than with paper . some commercial dental record products try to accomplish too much. moving from paper to electronics should be driven in part by effi ciencies. the tooth chart, which is an essential part of any dental record, must be such that examination fi ndings can be transferred quickly and accurately to either paper or electronic capture. a helpful exercise is visualization of the functionality of the charting process, including both the different types of entries (caries, existing restorations and pathology) and how these are entered in the paper world. if charting will be able to be used for research the system should be able to translate pictures to numerical values, often a complex programming function. dental practitioners and faculty may want to use drawings of teeth or graphics of surfaces because that is their current comfort level. a true digital charting is possible with no images of teeth, but some habits are hard to change. . maximizing drop downs with drop down building possible . duplication of paper chart entries using drop downs which can be upgraded as more clinical entities are found is a staple of an emr. the paper process usually relies on a clinician's wealth of medical-dental terms since inclusion of every possible, or even the most common fi ndings, is prohibitive on a paper chart. the emr drop down requires front-end loading of the most common clinical fi ndings with opportunity for free-hand additions. being able to add terms to any drop down is a needed capability. . don't design a system for uncommon contingencies, but for your bulk of work . a pediatric dental record should be primarily designed around dental caries, with secondary emphases on oral-facial development (orthodontics) and a lesser capability to record traumatic injuries and periodontal fi ndings. these second and third level characteristics can be hot-buttoned and should not drive the design of the basic system which is caries charting for % of our patients. sadly in most dental schools, the chart is slave to every teaching form, few of which ever exit with the dds into practice! these forms may have little relationship to patient care and only create "signature black holes" that need to be addressed, usually after treatment is completed. . progress notes should be designed for the routine entries with free-hand modification possible . student learners tend to write too much and a carefully crafted progress note format with standard entries in required fi elds helps patient fl ow and record completion. in federally funded clinics and residencies, attending reconciliation of student/resident service delivery is a compliance requirement. a well-designed emr system can "stack" required co-signing tasks on a computer screen, offer standard entries as well as free-hand options, and create a process far faster than paper records for an attending's validation (same as reconciliation?). . tie examination results to treatment planning and treatment planning into billing . a good system allows easy transfer of clinical fi ndings needing treatment into some problem "basket" and ideally in a tabulated format. an alternative is a split screen that allows a clinician to visualize clinical fi ndings, radiographic fi ndings while compiling a treatment plan. again, in clinical settings where compliance to medicaid/medicare regulations is required, the design of the record should give attention to auditing principles and security. a good emr system allows portals of entry for billing and compliance personnel. . plan for users of different skill levels and different periods of exposure . the teaching hospital or dental school environment often involves learners and attendings with varying skill levels and computer experience who may be there for brief periods of time. this reality adds signifi cant security and userfriendliness issues. some medical record systems are far too complex for shortterm or casual users. a well-integrated medical-dental emr allows navigation of the depths of the medical side should a user want to explore, but should focus on the dental portion. some suggestions in design: initial opening or logging into the dental portion for dental users, rather than • opening into the medical portion, clearly indicated options for exploration of medical portions, • orientation of major dental component (examination, radiographs, treatment • plan) in a logical dental treatment fl ow to replicate the way dentistry works rather than trying to reshape dentistry's normal fl ow to the record, minimization of seldom-used functions on the main dental screen, such as • specialty medical clinics, old laboratory tests and hyperfunctionalities like letter writing, clear identifi cation of existing non-caries dental portions like orthodontics or • trauma, so a novice user need not randomly search to see if a patient has any of these records. unfortunately, many pediatric hospitals do not yet have an ehr system that supports convenient communication among a pediatric patient's medical and dental providers. evidence of this state of affairs was provided unintentionally by (fiks et al. ) . some pediatric hospitals may have an awkward mix of systems serving physicians, dentists, and orthodontists and their shared patients. this section demonstrates how closely medical and dental professionals must collaborate to deliver appropriate oral health care for infants and children. such collaboration is especially important given the developmental vulnerabilities of children and the urgency of the oral health needs of many children, especially those from underserved populations. collaboration is made more diffi cult by the long-standing separation of medical and dental systems and poor oral health literacy of parents and medical professionals alike. teamwork in the delivery of pediatric care requires appropriate electronic patient record technology to facilitate sharing of patient information, to avoid patient record discrepancies between systems, and to create effi ciencies by maintaining only a single repository for patient demographics. only comparatively recently have appropriate integrated systems become available to support a range of clinical sites from pediatric special needs clinics to the largest children's hospitals. nationwide children's has given practical examples of effi cient decision-making in identifying an integrated system to acquire. much more work will be needed to develop the means to move towards integrating offi ce and community-based care for children through the sharing of electronic health records. oral health is an oft neglected area in the care of patients who have chronic kidney disease. furthermore, the provision of care by dentists and physicians to the same patient is fragmented as communication between the two health care providers is scant. emerging data suggesting the periodontal disease is closely linked to chronic kidney disease highlights the importance of proper oral health and the importance of communication between dentists and physicians in the care of the patient. investigators used data from nhanes iii, including information on , adults who had an oral examination by a dentist who categorized each patient as having no periodontal disease, periodontal disease or edentulous to examine the relationship between numerous risk factors for moderate to severe chronic kidney disease, as determined by calculation of estimated gfr through use of the mdrd formula (fisher et al. ) . no chronic kidney disease was defi ned as an estimated gfr of ml per min per . m . three percent of the patients had ckd, . % were hypertension and . % had diabetes ( . % with glycated hemoglobin of % or higher). four models were constructed to examine the potential relationship between periodontal disease and ckd. in model one adults with either periodontal disease or edentulous had an adjusted odds ratio of . (with % confi dence intervals of . - . ) of having ckd, independent of the other risk factors for ckd including of age above years, ethnicity, hypertension, smoking status, female gender and c-reactive protein elevation. the fourth model contained potential risk factors including the periodontal disease score and for every -unit increase in the score, the risk of having ckd increased by % controlling for the other risk factors. the authors hypothesized from their results that the relationship between periodontal disease and ckd was bidirectional in that ckd may increase the risk of periodontal disease which in turn increases the risk of ckd. grubbs et al. ( ) also used nhanes data to look more closely at the relationship between periodontal disease and ckd, using dental examinations obtained from to (n = , adults, - years) (grubbs v, et al. ) . in this analysis edentulous subjects were excluded and those with albuminuria were included in the defi nition of ckd. in the entire population ckd was present in . %, but in those with moderate to severe periodontal disease this increased to . %. other associations with moderate to severe periodontal disease were being older, male, nonwhite, less educated and poor. there was a strong relationship between periodontal disease and ckd ( . unadjusted odds ratio). when adjusted for age, gender, tobacco use, hypertension, diabetes, ethnicity, poverty and educational attainment, the odds ratio for the association of periodontal disease and ckd was still signifi cant ( . ). in some groups (mexican american, poor, and poorly educated) dental care was not received on an annual basis in the majority of this segment of the population. periodontal disease has been associated with an increased risk of death in hemodialysis patients (kshirsagar et al. ). this relationship has been poorly studied in peritoneal dialysis patients. this requires further study but it appears possible that periodontal disease might hasten loss of residual kidney function and perhaps contribute to atherosclerosis in dialysis patients and therefore, contribute to the high mortality in this population. patients who desire a kidney transplant are required to undergo a thorough evaluation beforehand including an oral examination by a dentist. some patients on dialysis have inadequate insurance which does not cover dental care, leading to a situation in which a kidney transplant is denied because the patient cannot afford the dental examination. communications between dentists and physicians in the care of the patient is scant. if oral surgery is required in a dialysis patient, the surgeon generally requires a brief summary from the nephrologist with recommendations. these might include suggestions for prophylactic antibiotics, avoidance of vasoconstrictor agents to an excess locally (which can elevate blood pressure) and the increased risk of bleeding of a dialysis patient. for more routine dental examinations no information is requested which could potentially lead to drug interactions or a dangerous situation. most nephrologists and health care providers in the dialysis unit do not inquire of the patient concerning dental health and examination of the mouth is quite uncommon. although the dialysis patient is seen monthly at a minimum, there is little conversation or documentation of oral health. connecting the electronic health records of in-patient care, the out-patient dialysis unit and the dentists' offi ce could potentially have a large impact in improving the care of those with end stage kidney disease. integrating medical and dental records in ehr's may or may not be the "golden ring." first, we need to integrate the clinical thinking…something we both realize is important, but not likely to be solved by an inert computer. i also think that integrated records will be very cumbersome, given the fact that the language used by the separate disciplines is so different, and the kind of detail required to support good decisions and good work is so different. it could be done…but for many professionals on either "side," they would never open the other module. to me, a more sensible solution may be to have a condensed "nugget" of information that could cross populate. "moderate periodontal disease" may be what the medical doctor needs to know, plus know what a treatment plan may include. she won't need to know the number of the teeth with the deepest pockets and erosions but will need to support the patient's determination to follow through. on the other hand, if the patient has shown remarkable initiative in gum care and has successfully migrated to a lower severity index, that would be important for congratulation and reinforcement…and also to encourage similar diligence in managing, let's say, the hypertension that is not optimally controlled. in the other direction, the dentist should know that a patient has been erratic in clinical follow up, does not self-test blood glucose, uses hypoglycemic drugs only intermittently, and has failed several appointments for eye exams. this would lead to a rather different set of approaches from a highly motivated grandmother who is enrolled in a community cultural center's senior exercise club, and is learning to become a lay community teacher for diabetes. right now, i don't think even this superfi cial degree of information is exchanged. we need to support each other's efforts, but we probably do not need to share minute details. the benefi ts of an electronic health record are well described. ehrs allow for legible standardized documentation and easier sharing of patient data between providers at multiple locations. they are less prone to loss and require much less space to store. they have the potential to result in a reduction in the cost of health care. a distinct disadvantage of the ehr, in its current confi guration, is the problem of information overload. simply put, there is often too much information presented in a way that is diffi cult to review and digest. the ehr equivalent of thumbing through a chart quickly is not yet available. as a result we frequently see practitioners look only at the last note or two as they review a patient's history. we require a way to communicate information directly relevant to patient diagnosis, treatment and prognosis among subspecialists and primary care providers. we require a way to identify subclinical cerebrovascular disease in a patient, independent of blood pressure and other traditional risk factors. we require a way to recognize which patients with cerebrovascular disease are two to four times more likely than average to develop a stroke in the next years. we have a way -retinal imaging. the eye is the one place in the body we can directly observe arteries, veins and a cranial nerve in a noninvasive manner. routine imaging of the retina and optic nerve could allow primary care providers to assess retinal, and by proxy systemic, end organ damage from atherosclerosis in an effi cient manner. the key to optimal use of the medical record and effi cient yet effective communication among providers may lie with the familiar adage; a picture is worth a , words. traditionally, when ophthalmologists communicate with primary care providers they send brief letters regarding the fi ndings seen during a yearly dilated examination and the presence, absence or progression of diabetic retinopathy. these letters end by exhorting the virtues of improved blood sugar, blood pressure and lipid control, a sentiment that the primary care provider likely shares. this system of communication does not provide particularly useful information for the primary care provider, except to serve as a notice that the standard of care screening guidelines have been met. the box has been checked. if primary care providers, cardiologists, nephrologists had access to routine ophthalmic imaging, they would be able to directly visualize the effect that suboptimal blood sugar control is having on their diabetic patients. as importantly, they would be equipped with information directly predictive of congestive heart failure, stroke, and cardiovascular mortality for their patient with hypertension, hyperlipidemia and for those who smoke. large clinical studies have shown that assessment of retinal vascular changes such as retinal hemorrhages, microaneurysms and cotton wool spots provides important information for vasculopathy risk stratifi cation. as an example, wong et al. showed that the presence of retinopathy indicates susceptibility to and onset of preclinical systemic vascular disease, independent of and qualitatively different from measuring blood pressure or lipids (wong and mcintosh ) . in the atherosclerosis risk in communities (aric) study, individuals with hypertensive retinopathy signs such as cotton wool spots, retinal hemorrhages and microaneurysms were two to four times more likely to develop a stroke within years, even when controlling for the effects of blood pressure, hyperlipidemia, cigarette smoking and other risk factors (wong et al. ) . in a recent study by werther et al., patients with retinal vein occlusions were found to have a two-fold increased risk of stroke compared to controls (werther et al. ) . in addition, the aric study group reported that individuals with retinopathy were twice as likely to develop congestive heart failure as individuals without retinopathy, even after controlling for pre-existing risk factors (wong et al. a ) . interestingly, even among individuals without pre-existing coronary artery disease, diabetes or hypertension, the presence of hypertensive retinopathy was associated with a three-fold increased risk of congestive heart failure events (wong et al. a ) . in the beaver dam eye study, cardiovascular mortality was almost twice as high among individuals with retinal microaneurysms and retinal hemorrhages as those without these signs ( wong et al. a, b ) . the aric and beaver dam eye studies have also shown that, independent of other risk factors, generalized retinal arteriolar narrowing predicts the incidence of type ii diabetes among individuals initially free of the disease (wong et al. a (wong et al. , b . a primary care provider with access to patients' retinal photographs may therefore have the evidence needed to suggest which patient with either established systemic vascular disease or preclinical systemic vascular disease requires a more aggressive treatment and risk factor modifi cation. they could do this without wading through the electronic equivalent of piles of records. one photograph could refl ect both acute changes in blood pressure (retinal hemorrhages, microaneurysms and cotton wool spots) and chronic changes resulting from cumulative damage from hypertension (av nicking and generalized arteriolar narrowing) (sharrett et al. ; wong et al. a ; leung et al. ) . in brown et al. out of patients, excluding those with known diabetes, that presented with a single cotton wool spot or a predominance of cotton wool spots on examination of the retina were found to have underlying systemic disease (brown et al. ) . systemic work-up revealed diagnoses including previously undiagnosed diabetes, hypertension, cardiac valvular disease, severe carotid artery obstruction, leukemia, metastatic carcinoma, systemic lupus erythematosus, aids and giant cell arteritis (brown et al. ) . these fi ndings illustrate the importance of retinal fi ndings on a systemic level. the utilization and integration of ophthalmic imaging may serve to achieve more effective communication among subspecialists and primary care providers and ultimately to provide improved diagnosis and treatment for delivery of optimal quality of patient care. moreover, the improved integration and maximal use of resources may serve to reduce overall health care cost and perhaps decrease provider frustration with the electronic health record (fig. . ). there are cotton wool spots, exudates, intraretinal dot-blot hemorrhages and microaneurysms. av nicking is also present especially along the superior arcade just as the vessel leaves the optic nerve ( fig. . ) . av nicking, tortuosity of vessels, intraretinal hemorrhages and dry exudates are seen ( fig. . ) . there is edema of the optic nerve head, with cotton wool spots and fl ame shaped hemorrhage along the disc margin. there are several cotton wool spots along the vascular arcades and scattered dot hemorrhages throughout the posterior pole and periphery ( fig. . ) . notice the cholesterol plaque in the vessel just as it exits the optic nerve head and the pallor in the superior macula corresponding to retinal ischemia and edema ( fig. . ). the cholesterol embolus has resulted in lack of blood fl ow to the superior arcade ( fig. . ) . there is pooling of subretinal blood just superior to the optic disc with a central fi brin clot and associated vitreous hemorrhage (fig. . ) . optic disc edema, fl ame hemorrhages and venous congestion are seen in a patient with severe hypertension. biju cheriyan in clinical practice, an otolaryngologist often needs a dental consult not only because of the topographically adjacent nature of the structures but also because most structures are supplied by the same neurovascular bundle and therefore there is overlapping of symptoms. the converse scenario can also apply. apart from this, there are many systemic medical conditions (for example: bleeding diatheses, diabetes) a hypertensive optic neuropathy dentist encounters throughout his or her practice which can determine the outcome of a successful treatment. sometimes, providers may observe a cluster of diagnostic criteria which may have to a single source. in the sections below, i will explore a few of these scenarios and conditions, and indicate where and how an integrated electronic health record (ehr) could optimize delivery of health care by dentists and otolaryngologists. cleft palate/cleft lip : cleft lip and cleft palate (cl/cp) are congenital conditions that require multidisciplinary management by dentists, oral and maxillofacial surgeons, orthodontists, otolaryngologists, speech pathologists and plastic surgeons a number of studies report that a multidisciplinary approach is essential for better treatment outcomes (wangsrimongkol and jansawang ) and for post operative rehabilitation (furr et al. ). these multidisciplinary approaches may lead to new ways to manage and treat cl/cp patients (salyer et al. ). hutchinson's teeth : notching of the upper two incisors is typically seen in individuals infl icted with congenital syphilis. macroglossia refers to enlarged tongue in relation to oral cavity. macroglossia is an important sign. it can indicate important systemic diseases like systemic amyloidosis, congenital hypothyroidism, acromegaly, or down syndrome. a common complaint that dentists and otolaryngologists encounter in their practice is the common headache. because of the special nature of the neurovascular bundle of the head and neck this symptom can be presented to both dentists and otolaryngologists (ram et al. ). any sinus pathology can present as a headache to an otolaryngology practice. since the maxillary sinus fl oor is in close proximity to the maxillary premolars and molars, it is imperative to obtain a dental evaluation in persistent cases of headache. there are a number of causes for headache from the dental and otolaryngology perspective. a mal-aligned denture patient with chronic headache, whom i saw in my practice was shuttled between departments and an array of investigations only to fi nd at the end that an ill-fi tting denture caused the intractable headache. in these cases, an integration of fi ndings is extremely important in providing quality treatment to the patient and also saves money and time for the whole health care system. hence it is important to have an integrated patient record for this particular symptom alone. trigeminal neuralgia is facial pain of neurogenic origin experienced along the distribution of the trigeminal nerve(fi fth cranial nerve). it can present as a dental pain and can also be triggered by brushing teeth among other trigger factors. as a result, patients with dental pain without obvious causes are required to have a physicians' consultation to rule out this obscure condition. sometimes it is diagnosed by omission (aggarwal et al. ; rodriguez-lozano et al. ; spencer et al. ). any tumor of the nasal sinuses (specifi cally maxillary and ethmoids) can erode the lower bony wall and present in the oral cavity (usually the maxillary arch) as dental pain, loose tooth, etc. therefore, these are areas of interest to both dentists and otolaryngologists. such tumors most commonly present fi rst to a dentist or could also be an accidental fi nding. cancers of the naso/oro/laryngo pharynx can also present as toothache to a dentist as these structures have a common nerve supply from cranial nerves , and . therefore, an integration of the patient record may even help in early diagnosis of the tumor. the same principle applies to all oral tumors, tumors of the nasopharynx, the oropharynx etc. this is especially true of malignant lesions of the oral cavity as these may help in early detection and treatment of cancer. in these cases, an early biopsy and histopathology can save the life of the patient. therefore, it is imperative to say that a collaborative patient record can save patients' lives. ulcers of the oral cavity from aphthous ulcers to carcinomas can present both to a dentist and an otolaryngologist. oral ulcers can be of dental origin. contact ulcers from sharp edges of a mal-aligned tooth can result in intractable ulcers, where a simple smoothing of sharp edges may eradicate the ulcer and terminate it as a chronic condition and can even prevent the ulcer turning into a malignancy. if you have an integrated electronic health record (ehr) these problems are immediately addressed and managed. otherwise, the condition will consume valuable time of both the patient and the physician concerned. in addition to this, there are a few conditions which require special attention: aphthous stomatitis (canker sore), which may indicate oral manifestation of defi ciencies of iron, vitamin b , folate deficiency and oral candidiasis, which can be a sign of diabetes mellitus or of an immunocompromised patient (e.g. aids). temperomandibular joint (tmj) disorders can present in a variety of symptoms to both dentists and otolaryngologists. they can present as a headache, earache, toothache, or as facial pain. there can be a number of causes for this including osteoarthritis of the tmj, recurrent dislocation, bruxism, or even an ill fi tting denture. there have been cases where patients have been subjected to removal of teeth for chronic toothache only to discover at the end that the symptom was a referred pain from tmj! therefore, an integrated ehr can prevent misdiagnoses and resulting impairment or disability to patients. trismus (lock jaw) can indicate important diagnoses such as tetanus and rabies.it is due to a spasm of muscles of mastication, which is an important oral manifestation of widespread muscle spasm. apart from these conditions, other causes of trismus are peritonsillar abscesses, and scleroderma. other problems dentists and otolaryngologists encounter in clinical practice are concurrent systemic diseases (patients with multiple problems): patients with bleeding diatheses, diabetes mellitus and a hidden primary malignancy. a non-healing ulcer in the oral cavity may hide a primary malignancy behind it. in these cases, you have to look for it specifi cally. similarly, one has to be aware of oral manifestations of internal pathology. some of them are crohn's disease, ulcerative colitis and gastro-intestinal tract malignancies. often dentists see patients after a tooth extraction with intractable bleeding to fi nd that they have a bleeding diathesis. so, this may be the fi rst presentation of these patients' bleeding disorder. when this patient undergoes any elective procedure in future, it will be a great help to surgeons to be aware of this information to prevent any inadvertent complications. therefore an integrated ehr can prevent unwanted complications where a patient's life may be in jeopardy. the source of otalgia or earache can be from a number of sites other than ear itself. technically ear lobe and ear canal are supplied by four different cranial nerve branches ( th, th, th, th). therefore, an area with a common nerve supply can present as earache. common dental problems which present as referred otalgia are ( ) dental caries ( ) oro-dental diseases or abscesses ( ) an impacted molar tooth (which is a common cause) ( ) malocclusion ( ) benign and malignant lesions of oral cavity and tongue (kim et al. ) . therefore, it is essential these two departments collaborate with each other in diagnosing and treating these diseases, and one way of facilitating it is through an integrated ehr system. there is a lot of overlap between dentists and otolaryngologists in the diagnosis and treatment of patients with halitosis (delanghe et al. ; bollen et al. ) . poor oral hygiene is the most common cause for this common complaint. oral causes include tooth caries, oral ulcers, periodontal diseases, unhealthy mucosa of the oral cavity. it is interesting to note that a simple oral ulcer can form an abcess eroding the fl oor of mouth and becoming a life-threatening oral cellulitis (ludwig angina). once the cellulitis has developed, it becomes a medical emergency. therefore, it is essential to prevent it before it can progress into a life-threatening condition, which of course is possible. causes pertaining to otolaryngologists include: chronic sinusitis or mucociliary disorder, chronic laryngitis or pharyngitis, pharyngeal pouches-related pathology, tumors or ulcers of naso/oro/laryngopharynx, diseases or conditions that impair normal fl ow of saliva such as salivary gland diseases or stones preventing fl ow of saliva, medications which cause dryness of mouth: antihistamines, antidepressants; local manifestation of systemic disorders: auto immune disorders, sjögren syndrome, dehydration from any cause, diabetes mellitus and gastro esophageal refl ux disorder (gerd). gerd is caused by improper neuro-autonomy of the lower esophageal sphincter (les). the les does not close tightly after food intake which causes gastric content to enter the esophagus. over time this can erode mucosa and cause various diseases even becoming cancerous (friedenberg et al. ). this disorder is attributed to life style. fast food consumption habits (oily fried foods) and eating habits (swallowing food without properly chewing) are partly responsible for this disorder (lukic et al. ; al-humayed et al. ) . here again an early diagnosis can manage the disease process before it is fully developed. at present there are no integrated ehr systems serving these specialties (dentistry and otolaryngology). an integrated ehr would facilitate effi cient communication between a dentist and an otolaryngologist who are providing care to the same patient and addressing a problem with a shared focus between the two disciplines. such integrated communication, may only require consulting the available medical or dental record of the patient, based on the particular circumstance. even enabling this simple communication would avoid duplication of effort, clarify the context of certain symptoms and reduce stress endured by the patient. it also has the potential to reduce healthcare delivery costs, and in some cases, even contribute to saving the patient's life. henry hood, allan g. farman, and matthew holder in this chapter, the authors attempt to put forth a justifi cation for precisely this kind of collaborative approach through a summary and discussion of a series of actual clinical cases. the protocols discussed in the management of each of these clinical cases illustrate the value in providing whole-person, interdisciplinary health care to this complex patient population. there is arguably no single patient population for whom the provision of collaborative, interdisciplinary health care is more challenging than for patients with neurodevelopmental disorders and intellectual disabilities (nd/id). in planning and delivering the generally-accepted standard of health care to this unique population, myriad biomedical, psychosocial and sociopolitical realities converge to create a landscape that is, at best, daunting for patients with these disorders, and for the clinicians who are charged with their care. anecdotal and scientifi c evidence suggest that this landscape has produced a paucity of physicians and dentists who are willing and able to provide care to patients with nd/id, and that american medical and dental schools are providing little training focused on their care (holder et al. ; wolff et al. ) . in february of , th surgeon general david satcher issued a report, which documented that americans with nd/id experience great diffi culty accessing quality health care (thompson ) . in that same report, former health and human services secretary tommy thompson said, "americans with mental retardation and their families face enormous obstacles in seeking the kind of basic health care that many of us take for granted." (thompson ) the disparities identifi ed by dr. satcher and secretary thompson require that physicians and dentists approach this population in a spirit of collaboration, compassion, and teamwork in order to produce positive health outcomes for them. perhaps, an even greater imperative driving the need for collaboration between medicine and dentistry in this arena is the fact that many patients with intellectual disabilities have developed this cognitive impairment as the result of an underlying neurodevelopmental disorder that is often undiagnosed. and it is this neurodevelopmental illness and the constellation of potentially devastating complications associated with that illness that create a biomedical fragility and a vulnerability that neither begins nor ends at the oral cavity, and that leaves these patients at risk in almost every aspect of their daily lives. when, for example, patients with nd/id are dependent upon publicly-funded programs for their health care, and when these systems fail to provide the health services that biomedically complex cases require because they fail to account for and accommodate the link between medical and dental pathologies, the risk of a negative outcome is greatly enhanced. such was the case for an intellectually disabled woman in michigan who, in october of , was unable to access dental services through the state's public medical assistance program, and who fatally succumbed to a systemic bacteremia resulting from an untreated periodontal disease (mich. dent. assoc. ). the american academy of developmental medicine and dentistry (aadmd) defi nes a neurodevelopmental disorder as a disorder involving injury to the brain that occurs at some point between the time of conception and neurological maturationapproximately age or (zelenski et al. ). examples of frequently-encountered neurodevelopmental disorders would include fragile x syndrome, a genetically acquired neurodevelopmental disorder caused by a mutation at the distal end of the long arm of the x chromosome (see fig. . ), trisomy , another genetic disorder, which features extra genetic material at the chromosome site (see fig. . ), and cerebral palsy, a prenatal or perinatal, acquired neurodevelopmental disorder (see fig. . ). patients with neurodevelopmental disorders tend to present clinically with one or more of fi ve frequently-encountered, objective symptom complexes or primary complications. these fi ve, classic primary complications include intellectual disability (aka: mental retardation), neuromotor impairment, seizure disorders, behavioral disturbances, and sensory impairment (aadmd). additionally, multiple secondary health consequences can derive from the fi ve primary complications; and any one of these secondary health consequences, or a combination of them, can produce profound morbidity. an example of a common secondary health consequence seen in patients with nd/id, which is derived from intellectual disability and / or neuromotor impairment, is the patient who is unable to care for his or her own mouth, and who develops ubiquitous caries and advanced periodontal disease as a result (see: fig. . ). another example would be the patient who suffers from the secondary health consequence of gastroesophageal refl ux disease (gerd) as a result of the neuromotor impairment associated with multiple neurodevelopmental disorders; and whose tooth enamel and dentinal tissues become chemically eroded as a result of the chronic intraoral acidity produced by gerd (see: fig. . ) . the diagnosis and management of these secondary health consequences provide dentists and physicians with a unique opportunity to work together to improve the quality of health and quality of life for their patients by implementing a team approach, which crosses the traditional interdisciplinary lines of communication, and which expands each clinician's ability to make meaningful treatment options available. indeed, it is often the case that quality primary care provided in one discipline will provide potentially valuable information to an attending clinician from another discipline. such is the case with the patients featured in figs. . and . . the patient whose intraoral photograph is featured in fig. . is a year-old male patient who presented to a special needs dental clinic accompanied by his mother. the mother indicated that her son was exhibiting hand-mouthing behaviors that she believed suggested he was experiencing mouth pain. a comprehensive radiographic and intraoral exam revealed, among other maladies, notched incisors, multiple diastemas, grossly decayed mulberry molars, and advanced periodontal disease. the patient also exhibited moderate to severe intellectual disability. these fi ndings were all consistent with a diagnosis of congenital syphilis. however, in developing the medical history with the mother, it was learned that no previous diagnosis of syphilis had been discussed with the mother, nor was it included in the health history. in cases like this, a comprehensive dental treatment plan should always include consultation with the primary care physician for purposes of moving forward with confi rmation of the clinical diagnosis by serologic testing, and consultation with a cardiologist to assist in the management of potential cardiovascular sequelae. as the dental treatment plan is being developed, consideration should also be given to human immunodefi ciency virus (hiv) testing for this patient, as coinfection is a common fi nding . this issue could easily be attended to by a primary care physician, an internist or an infectious disease specialist. in the absence of any of these team members, the dentist should feel entirely comfortable ordering hiv testing. the primary care physician and the developmental dentist should continue to advise each other and their respective consultant specialists of any signifi cant developments or new information, which could in any way impact either the medical or the dental treatment plan. as treatment progresses, both the physician and the dentist should expect improvement in the patient's periodontal status, which will likely be refl ected in a decrease in the frequency of immune-related illnesses, and in the maladaptive behaviors produced by chronic oral pain. it is quite often the case in this patient population that, with a reduction in maladaptive behaviors, comes a reduction of the use of psychotropic medications prescribed in a frequently futile attempt to manage behaviors that were born of an undiagnosed medical or dental illness. gerd is defi ned as the refl ux of gastric contents into the esophagus. gerd is primarily associated with incompetence of the lower esophageal sphincter; however there are numerous co-contributors, which may predispose a patient to gerd or exacerbate an existing refl ux problem. these co-contributors include a diet high in fat, neuromotor impairment associated with functional abnormalities such as dysphagia, neuromotor impairment associated with impaired ambulation and prolonged periods of recumbence, and the use of multiple medications including anxiolytics, calcium channel blockers, and anticholinergics. gerd is thought to affect approximately - % of the general us population. it has been established in the literature that the incidence of gerd in patients with intellectual disabilities is signifi cantly higher than in the neurotypical population, and that the relative number of unreported cases of gerd is much higher in patients with a neurodevelopmental diagnosis, as well. patients who have gastric refl ux as a function of a neurodevelopmentally-derived neuromotor impairment and a coexisting intellectual disability are impaired in their ability to voice the complaint that would, in the neurotypical patient, commonly lead to an encounter with either a family physician or a gastroenterologist and, ultimately, to a diagnosis. this inability to voice a complaint can be problematic in that, left untreated, gerd can produce maladaptive and sometimes aggressive behaviors in this population. and, of even greater concern, is the fact that undiagnosed esophageal refl ux can lead to more complex conditions that can produce signifi cant morbidity or even mortality -maladies such as barrett's esophagus or adenocarcinoma of the esophagus. chronic gerd can also produce an acidic intraoral environment, which can lead to the chemical erosion of the enamel and dentinal tissues of the teeth. ali et al. have established a link between erosion of the enamel and dentinal tissues of the teeth and gerd. there is additional anecdotal evidence suggesting a link between tooth enamel erosion and gerd, and related maladies. a special needs dental clinic in the eastern united states serving , patients with nd/id, has reported that, of nine patients referred to gastroenterology who presented for dental exam with a fi nding of either tooth enamel erosion or ubiquitous caries, two cases were diagnosed with gerd, two with barrett's esophagus, three with gastritis, and one with duodenitis. in all cases, medical treatment was required. in light of all that is known about the incidence of gerd and of the gerdrelated risks unique to this patient population; and in light of the link between tooth enamel erosion and gerd, it is incumbent upon any dentist encountering tooth enamel erosion in a patient with an intellectual disability to immediately refer that patient to gastroenterology for a work up, which should include esophagogastroduodenoscopy (egd) and ph monitoring. a dentist encountering gerd in a patient with an intellectual disability must be aware that he or she may be the fi rst and only link between that patient and the diagnosis of a potentially life-threatening illness. phenytoin-induced gingival enlargement can appear as either an infl ammatory lesion or a more dense, fi brotic hyperplastic lesion. the infl ammatory lesion is one in which the gingival tissues are swollen and bleeding, and in which pain is often a component. this type of gingival enlargement is the more acute lesion, frequently seen in patients who are currently taking phenytoin. in advanced cases of infl ammatory gingival enlargement, the tissues can appear botryoid, with a characteristic grape-cluster appearance. in advanced cases of phenytoin-induced gingival enlargement, the lesion can sometimes shroud entire sections of the dentition. phenytoin has long been a common medication used to treat seizure disorders in patients with neurodevelopmental disorders and intellectual disabilities. however, the gingival enlargement it produces, and the obstacle this lesion can pose to effective oral hygiene -especially in a population in which oral hygiene is typically compromised -can, over time, lead to periodontal disease, edentulism, and in advanced cases, systemic bacteremias. gingivectomy performed to reduce phenytoin-induced gingival enlargement will typically fail unless the patient is weaned off the offending medication, and another anti-seizure medication is titrated to effect. multiple alternative anti-seizure medications are currently available, which do not have the side effect profi le of phenytoin, and most patients who are weaned off phenytoin will demonstrate a virtual % resolution of the infl ammatory lesion within a matter of or months. the image in fig. . is of a year-old, microcephalic african-american male with intellectual disability, neuromotor impairment, and a seizure disorder. figure . illustrates the appearance of this patient's gingival tissues while he was currently on phenytoin. figure . features the same patient months after being weaned off phenytoin and placed on topiramate. these images illustrate the dramatic result that can be achieved when a dentist and a physician work in collaboration in the best interests of the patient. it is worth noting that this particular collaboration required only one intervention to achieve this result: the patient was weaned off phenytoin and was placed on a safer alternate anti-seizure medication. any dentist caring for a patient with an intellectual disability who presents with phenytoin induced gingival enlargement should immediately contact either the primary care physician or neurologist managing the patient's seizure disorder, and strongly urge that the patient be weaned off phenytoin and placed on a safer alternative anti-seizure medication. edentulism and bacteremia need not be a side-effect of a seizure management protocol. the patient seen in fig. . is a year old male patient with idiopathic intellectual disability who presented to an outpatient dental clinic for comprehensive dental evaluation and treatment. he was accompanied by his father. his father was referred to the clinic by the staff at his son's day program workshop. the day program staff had observed hand-mouthing behaviors, and they had voiced concern that the patient may be in pain. in the waiting room, the patient exhibited behaviors consistent with neurodevelopmental dysfunction. he was non-communicative, and his gaze aversion and tactile defensiveness were suggestive of autism. he was resistant and somewhat combative when directed to the dental chair, and effective behavior management in both the waiting room and operatory required the combined efforts of his father and two staff fig. . the adult patient suspected of having fragile x syndrome members. the patient's health history was positive for attention defi cit hyperactivity disorder (adhd), and there was no history of seizure or neuromotor impairment. the father indicated that, at age ten, the patient was admitted to an inpatient psychiatric unit for evaluation of his uncontrollable behavior. the following day, the parents were told that managing the patient's behavior was beyond the ability of the psychiatric unit staff, and the parents were asked to take the child home. the father also indicated that the psychiatric unit staff described the child's behavior as overwhelming. the patient was last seen by a dentist years prior to presentation; examination and treatment at that time were carried out in the operating room under general anesthesia. effective oral examination of this patient required utilization of papoose board and molt mouth prop. multiple options for behavior management, including utilization of general anesthesia in the operating room, were discussed with the father, and informed consent to utilize medical immobilization techniques for purposes of this examination was obtained and documented prior to taking the patient into the operatory. in the operatory a dental examination was performed, and a baseline panel of digital radiographs was obtained. the head and facial features of this patient were suggestive of fragile x syndrome (see: fig. . ) . the body of the mandible was somewhat elongated; the nose was prominent; the head had somewhat of a triangular shape, and the patient readily averted his gaze. upon further inquiry, the father reported that the patient also exhibited macroorchidism, although he indicated that no physician or dentist had ever suggested a work up for fragile x. fragile x syndrome is a disorder with which many clinicians are unfamiliar. yet it is the second leading genetic cause of intellectual disability in the united states, and it is the leading known cause of autism in the u.s. in addition to the phenotypic fi ndings noted in this case, there are other frequently-encountered physical characteristics consistent with fragile x that may move a clinician toward this diagnosis. they include pectus excavatum or funnel chest (see fig. . ) and joint laxity (see fig. . ) . gaze aversion, as previously mentioned, is a typical fi nding in autism and in fragile x syndrome. indeed, in conjunction with non-verbal behaviors, gaze aversion is often the fi nding that initially alerts the clinician to the possibility of a neurodevelopmental diagnosis featuring autism as a complication. figure . features a photograph of fi ve children at a school for children with special needs. four of the children have been diagnosed with autism, and a fi fth child is a neurotypical child who was visiting his brother on the day the photograph was taken. the reader is left to decide which child is the neurotypical child. any physician or dentist who encounters a patient with an obvious intellectual disability, who does not have an established underlying neurodevelopmental diagnosis, and who presents with additional fi ndings, which may include gaze aversion, shyness, a prominent chin, pectus excavatum, a large nose or large ears, should suspect a possible fragile x diagnosis. the primary care clinician -physician or dentist -should discuss with the guardian or family member the importance of establishing a neurodevelopmental diagnosis. the family member or guardian should be informed that genetic counseling should be made available to all members of the extended family, since fragile x syndrome is a genetic disorder that can be passed from parents to offspring. once this discussion has taken place, a referral to a geneticist for a complete genetic work up is indicated. both the dentist and physician should feel entirely comfortable making this referral. in remote areas where the services of a geneticist may not be available, the attending physician or dentist may order a high resolution chromosomal analysis and a fragile x dna test, and have those results sent to a remote location for interpretation by a geneticist. consultation with a psychiatrist or a clinical psychologist may also be advisable, as patients with fragile x can sometimes experience enhanced social integration as a benefi t of behavioral therapy. the healthcare access problem for americans with neurodevelopmental disorders and intellectual disabilities is, at its core, a healthcare education problem -an education problem resulting from a long-standing defi ciency in professional training focused on the care of this patient population. and it is clear that the medical and dental professions share equally in responsibility for these defi ciencies. eighty-one percent of america's medical students will graduate without ever having rendered clinical care to a single patient with a neurodevelopmental disorder or intellectual disability; and the graduates of % of america's medical residency programs will graduate from those residencies having had no formal training whatsoever -didactic or clinical -in the care of this patient population. additionally, % of graduating dentists have never treated a single patient with a disability. it is no wonder that patients like those whose cases were discussed in earlier sections of this chapter have such diffi culty accessing quality health care. as robert uchin, dean of nova southeastern university college of dental medicine observed in a speech in to his faculty, "not only do we not have enough doctors to care for these patients; we don't have enough teachers to teach them how to care for them." as a result of these defi ciencies in professional education, few clinicians with any expertise in developmental medicine or developmental dentistry are to be found in communities across america. the experts in developmental medicine and dentistry, for the most part, tend to be physicians and dentists who work at the few remaining intermediate care facilities, and at special needs outpatient clinics, psychiatric hospitals, and nursing homes. these physicians and dentists possess the knowledge and expertise in these disciplines because they are the physicians and dentists with the clinical experience. unfortunately for the patients with neurodevelopmental disorders who are clamoring for quality care, there are too few of these clinicians. national experts in developmental medicine and dentistry, however, have begun to collaborate in the creation of patient care protocols; and they have produced multidisciplinary curricula in both dvd and online format. the aadmd has made available hours of online curriculum in developmental medicine, developmental dentistry, and developmental psychiatry (see: list of urls). the curriculum program is entitled, the continuum of quality care , and it teaches collaborative patient care in three disciplines through an interdisciplinary format. the aadmd, through a grant from the wal mart foundation and the north carolina developmental disabilities council, and in collaboration with the north carolina mountain area health education center and the family medicine education consortium, has also established the national curriculum initiative in developmental medicine. this initiative, which is scheduled for completion in , will develop curriculum standards for physicians in the primary care of adults with nd/id. the curriculum stresses the importance of a collaborative approach, which includes medicine, dentistry, podiatry, optometry, and multiple ancillary health professions. if the disparities in access to healthcare for americans with nd/id are to be resolved, physicians and dentists must be willing to cross professional boundaries and work together to plan and deliver whole-person healthcare to their patients with nd/id. interdisciplinary protocols in the diagnosis of neurodevelopmental disorders and in the management of the secondary health consequences associated with these disorders must be established. additionally, clinicians with expertise in these arenas must be willing to work and teach in our nation's medical and dental schools. the clinicians with expertise must be willing to develop predoctoral and postdoctoral curricula, and the deans of america's professional schools must be willing to include these curricula as part of their larger programs in primary and specialized care. the clinicians with expertise in developmental medicine and dentistry must also be willing to conduct patient-focused, interdisciplinary, clinical research in an effort to solve the myriad problems that create obstacles to the delivery of the standard of care for patients with nd/id. they must be willing to obtain institutional review board approval for this research, and they must be willing to make this research available to their colleagues through publication in peer-reviewed journals and text books, and in professional lecture forums. the patient featured in figs. . and . is a man named james. he is a year old patient with idiopathic intellectual disability who presented to a dental clinic for evaluation of a painful facial swelling. a comprehensive intraoral exam revealed a cellulitis resulting from multiple grossly decayed teeth, and a generalized advanced periodontitis. no fewer than fi ve clinicians became involved in this patient's care. they included a general dentist, two oral surgeons, a family practice physician, and a geneticist. over the course of several months, as the treatment plan was completed, and as the chronic dental and periodontal infections were eliminated, james experienced signifi cant improvement in his overall state of health. a comparison of these two photographs reveals not only signifi cant improvement in his aesthetic appearance, but also in his skin turgor and color. these improvements in the patient's health translated to improvements in his daily life. he found gainful employment, and his caregivers now report that he smiles constantly -at work and at home. these photographs were entered into evidence in before a congressional subcommittee investigating the death of a young african-american boy who died as a result of an untreated dental abscess. the photographs were intended to make the point that patients with intellectual disabilities need not die as a result of medical illnesses derived from untreated dental disease. this patient's case illustrates that, when physicians and dentists are willing to work together toward a common goal of whole-person health for their patients, profoundly positive outcomes can be achieved. in a larger context, if our nation's medical and dental professions are willing to commit to a shared agenda, one which promotes the idea of collaborative, interdisciplinary care as a foundational concept, signifi cant improvements in quality of health and quality of life can be realized, not just for americans with neurodevelopmental disorders, but for every patient seeking quality care. in light of the events of , bioterrorism has become subject of increased attention from all members of society. government agencies, professional associations, academia, etc. have expressed their determination to wage war on such threats by all means available. dentists can also participate in this effort by providing assistance at interested groups and the general public (flores et al. ) . in this chapter we will examine the elements and components that may play a role in the establishment of an electronic network for the dental profession for supporting the fi ght against bioterrorism. in this section we review the threats, the public health system, current electronic surveillance systems, regulations and ethical issues, the computerization of dentistry, and how dentistry can serve in improving biosurveillance efforts. the aftermath of september and the anthrax incidents in october ( lane and fauci ) , made the us government reorganize its priorities and reform its current structure (white house offi ce of the press secretary ) . in response to these incidents, president bush proposed the "health security initiative" (white house letter ) in february nd of . this effort labeled the "bioshield initiative," (white house letter ) has the purpose to stimulate research and development of medical countermeasures against bioterrorism attacks. however, despite all these efforts, terrorist attacks are likely to happen in the future and even the best work from intelligence and security agencies will be unable to prevent such events (betts and richard ; council on foreign relations ; baker and koplan ) . to cope with this threat, a report published by an independent task force sponsored by the council on foreign relations "america-still unprepared, still in danger" (council on foreign relations ) , suggested a series of steps to assist the government in preparing to better protect the country. one of these suggestions is the bolstering of the "public health systems". baker et al. defi ne the u.s. public health system as a system that consists of a broad range of organizations and partnerships needed to carry out the essential public health services, such as hospitals, voluntary health organizations, other non-governmental organizations and the business community (baker and koplan ) which can collaborate with local, state and federal public health entities. after the unfortunate incidents in the public health system was revisited and the realization that "the nation's public health infrastructure is not fully prepared to meet this growing challenge" (frist ) became clear. to address this need, congress and president bush enacted the public law (p.l.) - titled "public health security and bioterrorism preparedness and response act of " (frist ; th congress ) . the main purpose of this law was to improve the public health capacity by means of increasing funding and fostering other measures. frist ( ) , described the law as a "good start" and that "to be prepared for bioterrorism, it is imperative that we develop a cohesive and comprehensive system of ongoing surveillance and case investigations for early detection". in this way, several early detection systems have been implemented with different levels of success among different geographic regions in the us. one of the most important initiatives over the years has been the establishment of the national electronic disease surveillance system (nedss) (baker and koplan ; nedss ) . the national electronic disease surveillance working group establishes that the "nedss is a broad initiative focused on the use of data and information systems standards to advance the development of effi cient, integrated, and interoperable surveillance systems at the state and local levels. the long-term objectives for nedss are the ongoing automatic capture and analyses of data needed for public health surveillance". the purpose of this system is to take into consideration and integrate the information of current public health systems implemented at different health department levels: county, state and fi nally at the centers for disease control and prevention (cdc). another initiative spearheaded by the cdc is biosense (looks ) . the purpose of this program is to develop advance detection capabilities of health related events including disease outbreaks. in addition, its emphasis is to improve situational awareness by integrating advanced analytics to process data generated by different health providers and other entities in the us. now that we have examined the general aspects, we will continue our background review focusing on the aspects that pertain to the specifi cs of the dental profession. this section will provide some perspective of the structure of the dental profession in comparison with its medical counterpart. "there are approximately , active dentists in the united states" (mertz and o'neil ) . in the dentistto-population ratio was of - , . and it is expected that by the year the ratio will be . , which translates into one dentist for every , people. " in contrast, the physician-to-population ratio has been increasing for the past years and now stands at per , , about one physician for every people." eighty percent of the dentists are in general practice. during march and of , the american dental association and the us public health service sponsored the conference "dentistry's role in responding to bioterrorism and other catastrophic events" (palmer ; national institute of dental and craniofacial research ) . this meeting reviewed several aspects of bioterrorism and the dental profession: the nature of biological pathogens and its oral manifestations, what needed to be communicated, how dentists should participate, etc. dr. michael c. alfano described the diffi culties that biological pathogens create for clinicians because "they are so insidious." while discussing the anthrax mailings after september th he pointed out that: "… early symptoms appeared so they resembled the aches, fever, and malaise of fl u so those affected delayed seeking treatment, a delay that has proven fatal in some cases". lieutenant colonel ross h. pastel of the us army medical research institute of infectious disease (usamriid) listed the "category a" pathogens as defi ned by the centers for disease control and prevention, and those are: smallpox, anthrax, plague, botulinum toxin, tularemia and viral hemorrhagic fever. he also described an outbreak of smallpox in yugoslavia in and the measure that had to be taken to control it. dr. michael glick described the oral manifestations of smallpox showing "signs hours before skin rash. these oral signs include tongue swelling, multiple mucosa vesicles, ulceration, and mucosal hemorrhaging. oral signs are also evident in inhalation and gastro-intestinal anthrax. in oropharyngeal anthrax the mucosa appears edematous and congested; there may be neck swelling, fever, and sore throat" . dr. ed thompson, deputy director of the centers for disease control and prevention mentioned that "none of the new counter-bioterrorism measures can be effective unless local health practitioners are vigilant in observing and reporting a possible disease outbreak. such surveillance-knowing what to look for and whom to report to-is critical and applies not only to suspected bioterrorist agents, but to a list of reportable diseases which has grown to include such entities as west nile virus and sever acute respiratory syndrome (sars)." dr. sigurs o. krolls presented the response at the local level and he "stressed the importance of communication and the need for redundant systems", "to keep all the parties informed". he also posed the question "can dentists recognize signs and systems of contagious diseases?", and emphasized that education can be essential. dr. louis depaola made several connotations that can be key in the scope of this paper by saying "dentists can contribute to bioterrorism surveillance by being alert to clues that might indicate a bioterrorism attack. such surveillance would note if there is an infl ux of people seeking medical attention with non-traumatic conditions and fl ulike or possibly neurological or paralytic symptoms… or even specifi c signs of a bioterrorist agent. patterns of school of work absence, appointment cancellations or failures to appear, could also be indicators." dr. depaola made clear that in cases of limited release of bioterrorist agents, dentists "have little to offer" but "a widespread attack can certainly tap into dental professional skills in recognition, isolation and management". in addition, dr. guay ( ) lists all the possible roles in which dentists can participate including "education, risk communication, diagnosis, surveillance and notifi cation, treatment, distribution of medications, decontamination, sample collection and forensic dentistry." dental informatics must pay attention to these and other recommendations, in order to develop integrated systems that take these recommendations into consideration. it is also important to understand that informatics has to work with technologies already in place like the computer-based oral health record and current standards. the fi nal recommendation from the meeting stated that to play an important role in biodefense, a serious amount of coordination and preparation will be required, not only from dentists but from other groups, most likely requiring medical and dental data integration. the cohr as described by rhodes ( ) "can provide a structure for documentation that goes beyond the concept of a blank form on a page, it includes a glossary of dental terminology for the entire content of the form as well as knowledge bases and expert systems that can enhance the practitioner's diagnostic and treatment planning decisions". he also acknowledges that one of the advantages of this type of documentation is that it "is much more transportable". he also recognizes the need for standardized methods for collecting information from dentists. schleyer and eisner ( ) defi ned several scenarios where the cohr is used in a "shared" environment where several healthcare providers interact and information is seamless communicated, improving the decisions made by clinicians. delrose and steinberg ( ) discuss how the "digital patient record" enhances clinical practice by providing "better quality information" to the clinician. although all of these benefi ts sound promising and encouraging some still express concern of the lack of standards among different information systems, which translates in communication breakdowns (schleyer ) . on the other hand, heid and colleagues ( ) mention a list all the steps that are currently being taken by different organizations such as the ada in order to produce a standardized cohr. other examples of standardization can be found in a paper presented by narcisi ( ) where ada's participation as a voting member in the american national standards institute has allowed edi or the cohr to be discussed and improved at a national level. additional infl uences in the standardization of the cohr are the security regulations mandated by hipaa, the health insurance portability and accountability act of . dentists are required to "adopt practices necessary for compliance" (sfi kas ; chasteen et al. ) . these and other regulations (szekely et al. ) will encourage the homogeny among different system vendors. computer ownership, on the other hand, has increased steadily during the last years. according to schleyer et al. ( ) in only % of dental professionals used computers in their practices compared to % in the year . additionally similar trends in internet connectivity where described. the issues mentioned above describe the issues that have to be considered in order to create surveillance system against bioterrorism for the dental profession. this review has tried to be inclusive by covering different aspects starting with the current state of affairs and environment, treats, technology, law, etc. next we present a blueprint for developing a biosurveillance system. the purpose of developing an electronic health surveillance system is to gather information from patients directly ( wagner et al. ) by detecting signs and/or symptoms, or indirectly by obtaining other types of information such as over the counter medication sales, patients' no-shows, usage of internet search engines keywords, etc. in this particular case, the proximity of contact between the dentist and the patient is equivalent to a medical inspection in terms of immediacy and/or closeness. such signs and symptoms can be easily detected if the dentist is properly prompted to search for them. this is just one example of ways how a system could provide assistance in the detection of a bioterrorism incident. but, before describing our proposed system, it would be important to address the fact that current syndromic surveillance systems have certain advantages in terms of its particular technological implementation . the rods laboratory obtains data directly from chief complains in the emergency departments from hospitals. the advantage of this surveillance system is that the implementation has to be made with only a limited number of parties (hospitals, clinics, health systems, etc.). on the other hand, our system would have to deal with thousands of different implementations (one in each dental offi ce). this and other challenges have to be considered when designing the proposed system: the proposed system should work at multiple levels: the system would have to provide a mechanism to alert the dentist if there is • suspicion that a bioterrorist attack may be happening. the mechanism would increase the dentist's awareness in case of fi nding suspicious signs or symptoms in a patient. this can be triggered by the patient's characteristics such as geographic location of residence, etc. automated collection of information from the patient's oral health record. the • system would report to a central database signs or symptoms of interest. the aggregation of this data could generate information that would eventually identify the presence of patterns that may lead to the early detection of such events. collection of additional information, which combined with other sources, can be • useful in terms of detecting or tracing some incident. patients' "no-shows" is the primary example, that, if combined with others such as work or school absenteeism can provide a relevant pattern for public health offi cials. dr. x, who practices in a community min away from capitol city, installed a new clinical management system months ago. among the features that were included in this new clinical management system (cms), a bioterrorism detection module was added. she felt curious because of recent news she read in the newspaper about possible attacks against the us and decided to install such feature. he read about how the module would work in combination with the cms she just bought. the educational information provided with the software instructed dr. x, that in case that a patient victim of a bioterrorism attack happens to be seen in her practice, the software would collect information and would send it to public health offi cials. when installing the software, dr. x was asked if she agreed to share such information with authorities. she was provided the option to receive notifi cation in case some information was sent but she decided not to enforce it. during the last week a patient walked into dr. x's dental offi ce. the patient presented some signs that indicated the presence of a disease; still its origin was not clear. an epidemiologic study later would show that the patient was present at the football stadium when an infectious agent was released (fig. . ) . although, at that time his medical history showed no indication of a systemic disease, the presence of multiple oral vesicles prompted the dentist to make an annotation into the cohr. the system, by using a natural language processing engine, detected such sign and sent this information to a central database. the patient was discharged and instructed to take some support medication to treat the oral ulcers. the next day, the central database pinpointed the presence of an out of the ordinary increase in the number of cases with the same signs and symptoms around that region. when the presence of this peak was detected, the central server sent a request to the dentist computer for additional information. one of the requested elements was if there was any use of medication for treating oral ulcers. fortunately this information was available. the central database crossed this with the information of other surveillance systems together with the information from other patients that happen to have similar clinical signs and/or symptoms. dr. x received an email from a public health offi cial asking her to communicate to the local health department to discuss information about one her patients. the case depicted above simulates the release of smallpox during a football game. in the case of smallpox oral symptoms include tongue swelling, multiple oral mucosal vesicles, ulceration, and mucosal hemorrhaging (national institute of dental and craniofacial research ) . dentists could be alerted by an electronic system to search for such signs or they can be detected automatically. in case of a high incidence within a group of patients, in a confi ned area, public health offi cials get to be notifi ed. in our hypothetical case there are issues that need to be addressed in order to make such detection system feasible: as described by schleyer et al. ( ) , % of dentists in the us use a computer in their practices. this fi gure would generate an estimate of , computers in dental practices. this prevalence of computers represents an opportunity for public health data collection. the creation of a software application for surveillance purposes must rely on existing technology. currently there are approximately major clinical management software packages in the market (dentistry today ) . out of these , clearly permit direct database manipulation. this characteristic can easily allow the creation of a "querying" application that would look for specifi c information within the data stored by those packages. additionally, a natural language processing engine could be embedded into the application in order to detect variations in data input on the computer oral health record. nevertheless, it is necessary to obtain a detailed list of the oral manifestations of diseases that are likely to be found on patients. successful implementations of similar systems have been shown to work successfully (chapman et al. ; ivanov et al. ) and using the same approach for our system seems technically feasible. this collected information later would be send to a central server in order to be analyzed and interpreted. the components of our system would be as follows (fig. . ) : thin client: a software application distributed for data collection. it would be • conformed of a "querying" mechanism, combined with a natural language processing engine and a communication module. this software client should be as thin as possible to reduce the work load on the dentist's equipment and should be embedded as a plug-in for current clinical management systems. vendors should be contacted to ask for their collaboration in the development of such application to ensure maximum compatibility and integrity of data collection. central servers: server software in charge of integrating all the data collected • from dental offi ces. it has to be capable of handling simultaneous requests from multiple users. this server would integrate all the data and would perform an analysis with the intention of detecting anomalies. it would be recommended that redundant servers should be located in different data centers with mirroring capabilities to guarantee their survivability in case of technical diffi culties. communication network: the transmission of information should be done using • the internet. this, of course, would essentially depend on the practitioner's current connectivity. if that is not available, backup connection to the central servers should be established. dentistry uses several standards for transmission of health related information. clinical management systems use standard-based technology to transmit information (narcisi ; chasteen et al. ; szekely et al. ; dentrix dental systems ) . dentists are aware of these standards and use them in a day-to-day basis to transmit information to insurers. additionally, in order to interact with other surveillance systems such as the nedss, our application should rely on the same standards. the software both client and server should be thoroughly verifi ed to be secure in terms of being safe against hacker attacks. on the server side, redundancy should be provided so downtime is reduced from design. the system should be developed so mirrored servers are always up and running. data integrity mechanism should also be considered. privacy and confi dentiality are important issues that need to be incorporated as part of a robust biosurveillance system and distinct regulations such as hipaa require protecting patient information (frist ; chasteen et al. ; bayer and colgrove ; etzioni ; ivanov et al. ) . in our hypothetical case we describe the use of several sources of information for detecting a bioterrorist attack. we described how syndromic information is transmitted to a central database which initially should be de-identifi ed. later, after the suspicion a bioterrorist attack more information is requested (medications) and more inferences are made. this, although technically possible, would require changing our processes and also the will to share clinical information. this leads to the discussion mentioned in the background section about "individual rights" vs. "common good". although hipaa addresses public health , some other implications may arise and the health professionals including dentists, physicians, public health offi cials and patients should discuss and address such issues. as discussed earlier, legislators face a diffi cult task in terms of determining what is best on behalf of the individuals they were asked to represent. legislation may have to be passed in order to guarantee the functioning of such a system. individual freedom and privacy are important values which may pose a confl ict when collecting individuals' information even for their own good. in any case, careful consideration has to be given to which information is required to detect a bioterrorist attack and also, by keeping in mind that it is always important to reduce, as much as possible, the collection and transmission of patients' information over the internet or any other network. a detection algorithm has to be created or adapted in order to determine the presence of a bioterrorist attack. some algorithms have proven their effectiveness (wong et al. a, b ) and it is likely that from these, a new analysis should be done in order to select or create one that addresses the particular needs of our system. a study was conducted to assess the feasibility of using oral manifestations in order to detect disease outbreaks (torres-urquidy et al. ) . it was found that for diseases such as botulism and smallpox it would be feasible to gather data that contains oral manifestations that would allow creating a detection signal using natural language processing followed by the use of statistical methods such as moving average to serve as part of a detection algorithm. the system should also be thoroughly evaluated, before and after implementation. to perform the evaluation before the system implementation computer simulation can be used to assess the effectiveness and likelihood of detection. simulation and modeling techniques (reshetin and regens ) have been used to estimate the effects of a bioterrorist attack. the same techniques can be used to evaluate our system. in case of the study by torres-urquidy ( ) , the investigators utilized synthetic outbreaks to test the performance of different signals. from their evaluation process, they learned, for instance, how many cases would be necessary to occur for the system to reach certain detection thresholds. several dental organizations have shown publicly their support of measures against bioterrorism. the american dental association and the national institute of dental and craniofacial research are two organizations who could play an important role in the development, deployment and ongoing support for our system. local dental societies also would also play an important role in the deployment of the proposed system. similarly, local, state and federal public health agencies should engage in activities that could make these mechanisms for health surveillance feasible. if dentists want to play an active role in the fi ght against bioterrorism, they should commit to collaborate with public health entities as well as to seek a way to integrate their information with the rest of electronic biosurveillance systems. professional organizations such as the american dental association can also participate by endorsing such efforts and by collaborating in the educational process of the dental professionals and their patients. as mentioned by dr. depaola (national institute of dental and craniofacial research ) dentists "have little to offer" in the current biosurveillance state of affairs. however, the integration of different technologies can change this perception. goldenberg et al. ( ) described over-the-counter medication sales as a technique for discovering disease outbreaks and stated that their approach may be "more timely" than traditional medical or public health approaches. medical cases that result from bioterrorism attacks do not produce symptoms until they have fully developed, so it is likely that different patterns can be detected before the patients start reaching the emergency department. as stated earlier (torres-urquidy et al. ) , it may be possible to have dentists participating of biosurveillance efforts, if we solve the proper organizational and technical challenges. dr. john r. lumpkin ( ) states that "hippocrates noted the health of the community was dependent on characteristics of a community and the habits of the people who lived there." dr. krolls (nidcr ) in his fi nal remarks during his presentation at the dentistry's role conference against bioterrorism, said, "dentists may pick up telltale information about what is happening in the community. after all, dentists spend more time with their patients than any other health specialty". kass-hout t, zhang x. biosurveillance: methods and case studies. muhammad f. walji maintaining patient records are essential for both clinical care and research. clinical research often occurs in the context of also providing patient care, yet the systems that are used for each are different and often cannot exchange data. the lack of data exchange between systems pose signifi cant barriers to effi ciently treating patient and conducting clinical research in dentistry. the purpose of this section is to review the benefi ts and challenges of integrating electronic health record (ehr) used for patient care and electronic data capture (edc) which is used for clinical research such as clinical trials. an increasing number of dentists routinely use ehrs (schleyer et al. ) . most dental schools in north america also use ehrs. benefi ts of using ehrs include increased legibility, portability, and improved patient safety (buntin et al. ) . recent federal incentives, although not directly benefi cial to dentists, will also likely spur the adoption of ehr (blumenthal and tavenner ) . clinical researchers, especially those conducting clinical trials, are also discovering benefi ts of using electronic data capture compared to paper. a clinical trial is a process in which new treatments, medications and other innovations are tested to evaluate safety and effi cacy. a standard part of health care, clinical trials are often lengthy and costly due to myriads of regulatory oversight. recent estimates set the cost of drug development in excess of $ million (grabowski et al. ) . accurately documenting data with suffi cient detail is critical for providing patient care and conducting clinical research. while the medical record is the foundation for patient care, the case report form is the foundation in a clinical trial. not all clinical research is clinical trials. clinical trials whose data will be submitted to the fda as a new therapy or device have additional requirements relating to the collection and transmission of the data. similarly for patient care data, ehrs need to meet the privacy and security requirements of hipaa. case report forms (crf) are a medium in which research study sites collect subject data in pre-defi ned formats for communication with clinical trial sponsors (rondel and webb ) many clinical trials data are collected on paper (rondel and webb ) . data measurement, collection, and recording are considered the "most crucial stage" in the data management process (hosking et al. ) . traditionally, study coordinators often record information in a case report form and subsequently mail or fax the crf to the centralized coordinating center. there, data entry staff, sometimes with the aid of optical character recognition systems, input crf data into a computer. errors made during this second data entry process are diffi cult to detect and correct (hosking et al. ) . lengthy guidelines in literature discuss methods for developing paper case report forms to reduce data entry mistakes (hosking ) . a well-designed crf may allow a user to effi ciently collect and record pertinent data. however, forms are often revised and redesigned during a clinical trial due to changes in protocol, unforeseen outcomes, or oversight (singer and meinert ) . there has been a recent drive to use electronic case report forms (ecrf). direct data entry at a study site shortens time to analysis and provides opportunities to audit data at time of entry. this could reduce data errors that might otherwise be caught weeks after submission. for quality control purposes, some studies require double data entry using computers and paper (day et al. ) , though alternative solutions have been explored including the use of data sampling (king and lashley ) and probability statistics to select only those forms likely to contain errors (kleinman ) . ecrfs may also facilitate data collection from existing electronic information systems such as lab systems. however, ecrfs are almost always reside in a separate system that is not linked to a patients record. although many clinical research studies are still being conducted using paper, an increasing number of studies are using ecrfs and electronic data capture (edc). for example, a review of canadian clinical trials found that % use edc (el emam et al. ). studies that are sponsored by a pharmaceutical company and are multicenter appear to use edc at a higher rate than those sponsored by government or a university. the cost of a commercial edc is substantial. recently a freely available edc has become popular amongst universities called redcap. a tool originally developed at vanderbilt university, it is now being used at over a institutions worldwide (harris et al. ). however, such tools are generally not integrated with the institutions ehr. although moving from paper to electronic will afford benefi ts there is a great need to allow data exchange between the patient care and clinical research components of information systems. although ehr and edc are similar, several challenges remain unresolved that prevent integration. one of the major barriers is likely to be different workfl ows for patient care purposes and to collect data for research. research is needed in defi ning an optimal workfl ow that can streamline the tasks associated with patient care and research, while at the same time providing a unifi ed information system that support these activities. also, the data that are collected for care and research are likely to differ. a researcher may require far more granularity of an oral health measurement than a clinician seeking to provide care. in cases when conducting a double blind placebo controlled clinical trial, the investigator may not even know the type of treatment that has been delivered to the patient. due to complexities of each domain, and large differences in goals, to date mutually exclusive workfl ows have arisen. a clinician investigator who sees a patient for both care and research, will likely need to enter data on this same patient twice; once in the ehr and once in the edc system. despite the availability of electronic systems, a major barrier is the integration and compatibility of disparate health information systems to converse with one another. the languages are important because they can help data sharing. clinical trials are not usually conducted in isolation, but are part of conventional medical care. therefore sharing data by clinical trials, patient care and laboratory systems becomes especially important with the adoption of ehrs in dentistry. in biomedical informatics, standardized terminologies are recognized as a critically important area to help better represent and share data for use in electronic systems (cimino ) . the systematized nomenclature of medicine clinical terms (snomed-ct), developed by the college of american pathologists, is the most comprehensive medical terminology (strang et al. ; chute et al. ) and is used in a number of health informatics applications. the us department of health and human services ( ) has also licensed snomed-ct, allowing access throughout the us at no charge. therefore snomed-ct is even more likely to be the vocabulary used in electronic formats of patient records in the future. the medical dictionary for regulatory activities (meddra) is terminology used by the fda and drug development industry to classify, retrieve, present, and communicate medical information throughout the medical product regulatory cycle (brown et al. ) . in particular it is used to record and report adverse drug event data. therefore standard languages are essential in sharing clinical trials data between sites, and also with regulatory agencies. no one single terminology is suited for all tasks. snomed-ct is likely to be more comprehensive to code clinical encounters, while meddra is more suited to help adverse event reporting. however, it is important that terminologies are widely adopted and used for similar purposes. even when standard terminologies are agreed upon, such information needs to be interchanged in standard formats. health level (hl ) is an important organization whose standards are widely adopted in healthcare to exchange information between computer systems. the clinical data interchange standards consortium (cdisc) is also an important group that helps to defi ne different data standards specifi cally for clinical trials research, such as clinical trials or regulatory submissions. one particular challenge in oral health has been the lack of a standardized terminology to describe diagnoses. although icd contains oral health concepts, they are often not granular enough to be useful for some patient care or research purposes. recently a dental diagnostic terminology has been developed by a group of dental schools, and has already been adopted by several institutions and used within dental ehrs (kalenderian et al. ) . the american dental association (ada) has also been developing snodent, but is not yet publically available for clinical use (goldberg et al. ). another link between ehr data and clinical research is the potential to fi nd human subjects. recruiting suffi cient numbers of patients that meet eligibility requirements within an allotted time frame for clinical trials is challenging. as ehrs contain detailed information about patients, they can be used to fi nd patients that meet specifi c inclusion and exclusion criteria. informatics for integrating biology and the bedside (i b ), an open source data warehousing platform, has been found to be a useful tool for cohort selection especially if the source data from an ehr is represented in a structured format (deshmukh et al. ). further, with health information increasingly available to patients through the internet, it is possible interested patients will be more effective in fi nding clinical trials than investigators looking for patients. many clinical trial registers are now available online. the national institutes of health (nih) have made available their database of nih funded research (mccray ) . there is currently no single repository for patients to fi nd all trials studying a health condition. a recent study assessed the comprehensiveness of online trial databases concerning prostate and colon cancer and found that online trial registries are incomplete, especially for industry-sponsored trials (manheimer and anderson ) . a more collaborative effort between government and industry-sponsored research groups to compile and standardize information may be a mutually benefi cial effort. it is not clear how many patients now enroll in clinical trials through online discovery. ehr data originally collected for patient purposes can be potentially used for research. aggregating data from multiple sources can provide a large dataset that could otherwise not be available. electronic health records (ehr) contain a wealth of information and are a promising source to conduct research. data extracted from ehrs differ from other sources such as population surveys or data obtained from payers, as they provide a more detailed and longitudinal view of patients, symptoms, diseases, treatments, outcomes, and differences among providers. therefore ehr data in dentistry can potentially provide valuable insight into oral health diseases, and treatments performed on a large cohort of subjects. ehrs also play an important role in enhancing evidence-based decision-making in dentistry (ebd) and improving clinical effectiveness through decision support (atkinson et al. ; walji et al. ; valenza and walji ; taylor et al. ; spence et al. ; chambers et al. ; langabeer nd et al. ; walji mf et al. ). the consortium of oral health related informatics (cohri) provides an example of how dental ehrs are used for research purposes (schleyer et al. ; stark et al. ) . cohri was formed in by a group of dental schools who used the same ehr platform and who are interested in sharing clinical and education data. through funding from the national library of medicine, four dental schools are participating in a pilot project to develop an inter-university oral health research database by extracting and integrating data from ehrs. one promising area where data repositories derived from ehr data can be used for new discoveries is in the area of comparative effectiveness research. comparative effectiveness research is defi ned as "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients." (congressional budget offi ce ) further, such research includes focusing on the clinical benefi ts and risks of each option (clinical effectiveness), and an analysis on the costs and benefi ts (cost effectiveness analysis). comparative effectiveness research (cer) is also likely to reduce costs of dental care and increase access to the majority of the population who currently receive no dental care. unfortunately many recent systematic reviews focusing on cer questions in dentistry have been inconclusive due to the lack of existing evidence in the scientifi c literature. secondary analysis of the data that reside in dental electronic health records (ehr) is a particularly appealing approach to facilitate cer and generate new knowledge. ehr data has the potential to provide a comprehensive picture of patients' histories, treatments, and outcomes, and if integrated with similar data from other dental clinics can include a large and diverse set of patients. however, numerous challenges must be solved before ehrs can be used for cer. first, data suitable for cer must actually be collected from ehr systems. second, this data, which often resides in proprietary systems, must be accessible and retrievable. and lastly, this data should be structured in a format that can be integrated with data from other sources or institutions. practice-based research networks (pbrn) are groups of primary care clinicians and practices working together to answer community-based health care questions and translate research fi ndings into practice. pbrns engage clinicians in quality improvement activities and an evidence-based culture in primary care practice to improve the health of all americans. in , the national institute of dental craniofacial research funded three such research networks. the dental pbrn's to date have been conducting both prospective and retrospective research. for example, barasch et al. conducted a case controlled study to investigate risk factors associated with osteonecrosis of the jaws . many prospective studies conducted as part of pbrns still require separate data collection systems for the research data. ehr data contained in practices as part of pbrns are beginning to be used for secondary purposes. for example fellows et al. conducted a retrospective analysis of data contained in electronic health records to estimate incidence rates of osteonecrosis of the jaws ( fellows et al. ) . pbrns provide great promise of how ehr and clinical research data can be used effectively to promote both patient care and new discoveries. another area that intersects both the patient care and research realm are patient registries. patient registries are ways to track groups of patients who have had specifi c diseases or have had certain treatments. while ehr data would contain information on all types of patients, their diseases, and treatments, registries would allow focus on specifi c diseases or treatments of interest. registries would not be as costly in terms of resource requirements like a traditional clinical trial, but would require specifi c eligibility criteria, informed consents, and collection addition to that collected as part of routing care. dentistry has lagged far behind in forming data registries, primarily because dentistry is practiced in small offi ces and not in large hospitals making the process of integrating data very diffi culty. however, dental schools which themselves house large clinical operations are ideally positioned to create disease specifi c registries that can potentially use data collected for patient care and extend for research purposes. there is great potential for providing new insight in oral health by the integration of patient records and clinical research from both a workfl ow and information systems perspective. the technology challenges of developing systems that can exchange data, and use standardized terminologies appear solvable. however, the socio-technical issues such as determining how to incorporate optimal workfl ows for conducing both patient care and research with minimal additional overhead appear to be the greatest challenge before widespread adoption. similarly, there appears to be great potential in using ehr data originally collected for patient care for the secondary use of research and discovery. this will require collaboration between patients, providers and researchers from all healthcare disciples, and institutions with friendly policies for sharing data to improve both patient care and drive new discoveries. amit acharya , andrea mahnke , po-huang chyou , and franklin m. din more recently there has been a strong push from the united states federal government for the adoption of the electronic health record (ehr) within the healthcare industry. as a result, $ . billion is made available to incentivize the physicians, dentists and hospitals for the adoption of the ehr through the health information technology for economic and clinical health (hitech) act. as the nation head towards adoption of the ehrs, there has also been a growing interest with the majority of the u.s. dental schools to implement ehrs within the educational setting. fifty of the fi fty-six u.s. dental schools, as well as dental schools in canada and europe, are either using or in the process of adopting some aspects of a common dental ehr framework (white et al. ) . a group of dental schools known as consortium for oral health-related informatics (cohri) was formed in which used this common dental ehr framework -axium (stark et al. ) . currently there are about dental schools within cohri. the ehr will not only support clinical care, but will also result in training the next generation dental students and to conduct innovative research that was not possible earlier. however, not much is known about how many of these dental schools' electronic dental records are integrated with their respective university's electronic medical record. a common medical-dental ehr model at healthcare universities would enable a holistic approach to providing patient care and provide the much needed electronic infrastructure to study interrelationship between the various oral-systemic diseases. recently a group of researchers from marshfi eld clinic in wisconsin, us conducted a survey to investigate the current states of health information technology and informatics within the dental school in the us. list of us dental schools were identifi ed through the american dental education association (adea) web site. dental schools were contacted to determine who the most appropriate person to take the survey would be. once the list of contact was developed from each dental school, an email was sent to us dental schools with a link to a survey created in surveymonkey. the survey was administered on tuesday march , . reminder survey emails were sent to all recipients on march and march . the survey was closed on march . the anonymous survey was at most questions, depending on how questions were answered. the survey focused on topics such as presence of dental informaticians within the dental schools, use of fi nancial and clinical information systems, interest in federal stimulus support for ehr adoption provided through american recovery and reinvestment act and meaningful use of ehr, relationships with health care entities and bidirectional nature of the dental and medical ehrs. the study was approved as exempt from the marshfi eld clinic institutional review board under section cfr . (b) and waived requirement for an authorization. thirty out of the fi fty fi ve dental schools responded to the survey (response rate of %). however, fi ve of the thirty dental schools representative did not complete the survey and hence their response was not included in the analysis. regarding the question about the presence of a dedicated department or a center for information technology (it) or informatics within the dental school in us, % (n = ) of the responding dental schools had a dedicated it/informatics department or center (p-value of . ). the it or the informatics department size (in terms of the number of personnel) at the dental schools is illustrated in fig. . . thirty fi ve percent (n = ) of the us dental schools that housed an it / informatics departments had personnel with not only it training but also dental informatics training. while % (n = ) of the dental schools were considering integration of dental informatics personnel within their department or center. twenty fi ve percent (n = ) of the dental schools did not have any plans of integrating personnel with dental informatics personnel within their department or center (see fig. . ). partial responses to additional questions in the section of the survey is provided under table . . the majority of the responding dental schools were currently using financial electronic systems (fes) (p-value of < . ) and electronic dental records (edr) (p-value of . ). the use of fes outnumbered the use of edrs in the dental schools (see fig . ) . about % of the dental schools that were currently utilizing the edrs used it in all the clinical modules (p-value of . ), while % of the dental schools used the edrs in some of the clinical modules. when asked about the commercial edr system that the dental schools were using, axium (exan group, canada) was by far the most implemented edr system. two dental schools had salud (two-ten health limited, ireland) implemented and two dental schools had gsd academic (general systems design group, iowa, us) implemented. combinations of two ehr systems (home grown and dentrix) were implemented at two dental schools. one school had a dentrix only implementation, while another had developed its own edr system (home grown) (see fig. . ). there were dental schools which had implemented an edr fi ve or more years ago, dental schools - years ago, dental schools - years ago and dental schools less than a year ago (see fig. . ) (p value of . ). when the dental schools were asked the question as to whether they were expecting to apply for the medicaid meaningful use incentive program, majority ( %) of the dental schools did not know and only % of the dental schools were expecting to apply within the next years (fig. . ) (p-value of . ). challenges or barriers identifi ed by some of the dental schools in complying with the meaningful use objectives were (a). lack of certifi ed edr and information regarding it, (b). issues with getting auxium certifi ed and (c). qualifi cations of the edr as many of the meaningful use objectives do not apply to dentistry and lack of specifi c information about it. only % of the responded dental schools were part of a health system. fifty two percent (n = ) of the responded dental schools had a formal relationship with other health care delivery entities in terms of sharing facilities, patient transfer, training programs. some of the types of relationship mentioned by the dental schools that had a formal relationship with other health care delivery entities included: (a). a gpr program and an emergency dental unit in the hospital, (b). affi liated hospital, (c). affi liation agreements, (d). oral and maxillofacial surgery (omfs), anesthesia and pedodontics all have some portion of education in medical health center, (e). omfs residents are also residents of medical health center, (f). residents providing care under contract with area hospitals, (g). sharing patients wand facilities with the health center, (h). students rotating in the community health centers and (i) collaborative grand programs. eighty fi ve percent of the dental schools that had a formal relationship with the health care delivery entities had routine interaction with them because of their existing relationship (p-value of . ). their usual method for exchanging information was through informal medium such as phones, emails and faxes and formal medium such as memorandums, letters and contracts. when the dental schools were asked about the communication between the health systems' emr and the school's edr, majority of the dental schools did not have any communication ( %) or did not know is such a communication existed ( %) (p-value of < . ) (see fig. . ). out of the % (n = ) of the responded dental schools who's edr did not communicate with the health system's emr, % (n = ) of the dental schools stated that they did not need to exchange patient information electronically as a reason for the non-communication, while % (n = ) dental schools states that they would like to exchange patient information electronically but there were barriers that prevent them from doing so. some of the barriers identifi ed by these dental schools were (a). the hospitals and the dental school are not part of the same medial system and hipaa concerns prevent sharing data, (b). the dental school currently neither did have an edr nor the infrastructure to support one and (c). hospital is not interested and has high and perhaps unrealistic security standards. the remaining % (n = ) of the dental schools expected to exchange patient information electronically in the near future (next years). some of the information categories that were shared between the edr and emr in the small number of dental schools are illustrated in fig . . finally when asked about any research projects under way in their dental school to investigate discrepancies between medical and dental records for the same patient, only ( %) dental school was currently undertaking such project. in all common diseases, including those that affect the oral cavity, both the environment and genetics are pathogenic conspirators. unfortunately, we currently know little about the specifi c mechanisms underlying any common disease; and oral diseases are among the least understood. elucidating the etiology of chronic oral diseases will involve a synthesis of results from careful experiments of environmental exposures such as diet and tobacco use, the oral microbiome, co-morbidities, largescale, well-designed genetic studies, and the various interaction effects. with regard to genetics, the past few decades have witnessed transformative developments in our ability to interrogate the entire genome for genes that contribute to disease. while dramatic advances in experimental designs, statistical approaches, and clinical insights have greatly aided this scientifi c campaign, the central driver of this progress has been the development of high-throughput, inexpensive genetic technologies. following initial molecular studies using variant forms of enzymes, or allozymes, a major breakthrough was the use of highly informative dna-based markers throughout the genome (botstein et al. ) . this idea of directly assaying existing dna variation to conduct linkage and association studies in genetics began a revolution in disease gene mapping. recent interest from commercial entities has produced a feverish pace of technological innovation, markedly reducing cost and expanding the depth of inquiry. previously unfathomable, the testing of over one million single nucleotide polymorphisms (snps) in thousands of patients and controls is now commonplace (wellcome trust case control consortium ; schaefer et al. ) ; and very recently, next generation sequencing technologies have progressed to the point where sequencing of the entire protein-coding portion of the genome (exome) or even the entire genome is a costeffective method to examine disease traits across the entire spectrum of genetic variants in small numbers of affected individuals (ng et al. ) . there is little doubt that soon whole genome sequencing will be applied to nuclear family-based designs, studies among distantly-related affected individuals in extended pedigrees, and case/control studies involving thousands of individuals. this unprecedented scope of inquiry made possible by large-scale genetics, has begun to yield fascinating resulting into predisposition to oral cancers, caries, and periodontal disease that will molecularly redefi ne these pathologies, explicate unique biological connections with related diseases, give impetus to the development of directed therapeutics, and indeed personalize medicine. still, much more genetic focus on oral disease phenotypes is required if we are to realize this medical impact in a timely fashion. as genetic technologies have allowed the progression of interrogating single protein variants to single dna markers to entire genes to markers across the genome, and now to the entire genome sequence, the promises of these large-scale genetic studies have understandably undergone monumental expansion. it may be reasonable to expect the results from whole genome sequencing to decidedly revolutionize medicine within the next two decades. however, this new scientifi c capacity comes at a cost. as genetics, and biology in general, transitions to a data-rich science, practitioners have found themselves woefully unprepared to store and analyze the volume of data generated. once analyzed, interpretation and integration of these abundant and multifaceted results into medical practice will also be an appreciable challenge. insuffi cient assimilation of genetic fi ndings into merged dental and medical records will severely limit the ability of clinicians to appropriately treat patients. inadequately addressing these informatics issues will severely derail efforts in the basic sciences efforts as well as the translational and clinical sciences. this chapter explores the current state of genomics studies, what we have learned from genetic investigations into oral diseases, and where we may be headed. genetic studies have much to offer investigations of disease etiology. why do some acquire diseases and others do not? for those affected, why do some progress more rapidly than others? what causes some patients to respond to therapies, while others suffer from adverse reactions? these are all fundamental questions in both biology and medicine, whether the focus is on the gastrointestinal tract, the hippocampus, the lymphatic system, metabolic disorders, or oral diseases. speaking generally across disease areas, a portion of the answers to these questions often lies in described environmental effects. in numerous chronic diseases, infectious agents are likely contributors to the disease process -periodontitis, for example, is initiated by gram negative anaerobes in susceptible individuals (holt and ebersole ) . surely, unique and latent environmental exposures provide a random component to common disease susceptibility and progression. through twin studies, studies of risk in close relatives, and quantitative traits experiments, it is well-understood that heritable factors, including but not limited to dna variation, are typically responsible for - % of the phenotype variability for common diseases. this section will attempt to cover, at least at a cursory level, the major salient developments affecting genetic insights into chronic and aggressive periodontitis, with some comment on genetic factors infl uencing susceptibility to caries and oral cancers. while it would be extremely naïve to view genetic studies as an immediate panacea for our ills, the discovery of disease-causing genes does illuminate hitherto unknown biological pathways and molecular mechanisms, draws unforeseen connections with other traits, may improve prognostic models applicable for individuals, and suggests specifi c therapeutics. industrialization has brought forth increased lifespan and wellness through vaccination, modern sanitation practices, public health policies, and advances in medical science translated into practice. however, the accompanying physical inactivity coupled with a high calorie diet are probable contributors to an extremely common, chronically infl amed metabolic syndrome (hotamisligil ) that is thought to give rise to a multitude of intimately related disease traits: insulin resistance, compromised insulin signaling, hyperglycemia, obesity, dyslipidemia, hypertension, impaired kidney function, elevated liver enzymes and steatohepatitis, poor wound healing, neurodegeneration, vascular disease, pregnancy complications, accelerated immunosenescence, and periodontal disease (ford et al. ; ferrannini et al. ; eaton et al. ; holvoet et al. ; speliotes et al. ; eckel et al. ; d'aiuto et al. ) . these diseases often co-occur within the same patient and could be considered variable expression complications arising from a state of aberrant caloric fl ux that induces metabolic dysfunction and chronic, systemic infl ammation. these features constitute a disruption in a fundamental homeostatic mechanism with intensifying pathogenic consequences. the rapidly increasing incidence and decreasing age of onset for this pathophysiological state have generated a major source of mortality and morbidity in modern cultures (ford et al. ; ferrannini et al. ; weiss et al. ) . it is becoming increasing clear that many chronic diseases have an infectious component. there is relatively convincing evidence that many systemic, t-cell mediated autoimmune disorders may be initiated by infections. for example, from archaeological data, it is believed that an infectious agent -currently unknown -is necessary for rheumatoid arthritis (firestein ) , and both guillain-barre syndrome and rheumatic fever have well-described pathogeneses triggered by specifi c infections in susceptible individuals (bach ) . in many instances, oncogenesis and tumor progression can be traced to pro-infl ammatory responses at the site of chronic infection (coussens and werb ) , although it is not known whether these effects are mediated through the actions of the immune system, the infectious agents, or a combination thereof. several cancers fall into this category including gastric adenocarcinoma (uemura et al. ) , cervical cancer (walboomers et al. ) , hepatocellular carcinoma (saito et al. ) , and kaposi's sarcoma (dictor ) , all having unequivocal infectious agent etiologies. recent fi ndings of antiinfl ammatory pharmaceuticals, particularly those that inhibit cox- and cox- , reduce the incidence of certain classes of cancers are consistent with this view (dannenberg and subbaramaiah , rothwell rothwell et al. ) . in addition, there is moderate evidence that several bacteria -the most studied is chlamydia pneumoniae -play a role in atherosclerosis and myocardial infarction (saikku et al. ; watson and alp ) , however the studies are not conclusive and antibiotic treatment does not appear to be effective (andraws et al. ) . chronic periodontal disease is fi rmly footed at the intersection of infection, chronic infl ammation, and metabolic dysfunction. chronic periodontitis is characterized by infl ammation of the periodontal membrane, slowly causing gingival recession and eventual bone loss. the proximate cause of periodontitis is the virulent oral microbiome. the involvement of gram negative anaerobes has been fi rmly established for the disease. aside from the known oral pathogenic species p. gingivalis , t. denticola , and t. forsythensis , the so-called "red complex" (holt and ebersole ) , new bacterial species associated with chronic periodontitis have also been described (kumar et al. ) . the advent of an extensive database covering the oral microbiome will surely propel such investigations . numerous studies have shown that periodontal disease covaries with many diseases, presumably due to overlapping molecular etiologies. compelling meta-analyses demonstrate a highly signifi cant synchronicity of obesity and periodontal disease (chaffee and weston ) . in addition, the correlation between periodontal diseases/ alveolar bone loss and frank metabolic syndrome is repetitively observed (nesbitt et al. ; andriankaja et al. ) . extensive work has also shown a strong role for both infl ammation-related genes and circulating infl ammatory markers in periodontal disease (nikolopoulos et al. ; bretz et al. a, b ) . treatment studies further support the link between periodontal disease and immuno-metabolic syndrome. these experiments have demonstrated a signifi cant improvement in intermediate molecular markers of infl ammation when chronic periodontitis in the presence of metabolic syndrome (acharya et al. ) or type diabetes (iwamoto et al. ) was treated. conversely, treatment of periodontal disease with reduction of bacterial load leads to greater glycemic control among diabetic patients (simpson et al. ; stewart et al. ) . given the high prevalence of periodontitis and the co-morbidity of metabolic syndrome with periodontal disease, these treatment experiments appear to suggest that the virulent oral microbiome could play an important role in the pathogenesis of systemic infl ammatory metabolic syndrome, and is exacerbated by the syndrome. certainly, further studies are needed to defi nitively answer this question. as chronic periodontal disease seems to be a critical feature of sustained, systemic dysfunction of both metabolic and infl ammatory networks, uncovering the genetic variants carried by susceptible individuals would not only provide much needed insight into the molecular pathogenesis of chronic periodontal disease, but would also markedly aid our understanding of the infl ammatory metabolic syndrome and how it drives related co-morbidities. such genetic studies may also shed light on the specifi c mechanisms that appear to improve cardiovascular, infl ammatory, and diabetic outcomes when periodontal disease is treated, potentially leading to therapies and medical/dental intervention with greater effectiveness. such studies may also provide clues to which subsets of individuals respond more effectively than others and why they do so. periodontal disease can also present in a rapid manner with aggressive bone loss and early-onset. this is termed aggressive periodontitis (lang et al. ) . in contrast to chronic periodontitis, there is often a greater degree of familial aggregation with aggressive periodontitis, and it is hypothesized that most aggressive cases may affl ict individuals with one or more defective immune genes (zhang et al. ; amer et al. ; machulla et al. ; carvalho et al. ; toomes et al. ; hart et al. ; hewitt et al. ) . mutations in the lysosomal protease, cathepsin c, have been shown to be responsible for some forms of aggressive periodontitis, along with complications associated with other infl ammatory diseases (laine and busch-petersen ) . the specifi c hla variants thought to play a role in aggressive periodontitis, are also involved in infectious disease susceptibility and autoimmunity; and, interestingly, two of the non-mhc-linked regions, fam c and a locus on chromosome p , have been implicated in myocardial infarction (connelly et al. ) and may have action as a tumor suppressor in tongue squamous cell carcinoma (kuroiwa et al. ) . as with chronic periodontal disease, an infectious microbiome is heavily involved. however, in general, microbiome differences could not explain the presence of chronic versus aggressive forms of the disease, although in some aggressive periodontitis patients, a highly leukotoxic a. actinomycetemcomitans strain may contribute to the disease process (mombelli et al. ) . we currently do not fully know the differences between the genetic susceptibility factors for the chronic and aggressive forms of the disease. the most prevalent chronic disease in both children and adults is dental caries (national institute of dental and craniofacial research) . caries formation is a complex disease with several interacting components form the environment and host genetics. similar to gingivitis and periodontitis, caries have an infection-initiating etiology with acidifi cation leading to localized demineralization. epidemiological studies have long shown that diet is a strong predictor of caries formation; and the reduction in ph is exacerbated by high consumption of carbohydrates. the principal pathobacterial species are streptococcus mutans and lactobacillus ( van houte ) . there are also several reports of positive correlations of caries with infl ammatory diseases, although the association is not always repeatable. it is also not clear what proportion of the putative association with infl ammatory disease is due to innate upregulation of immune networks in contrast to the immuno-modulating pharmaceuticals prescribed to those with infl ammatory disease (steinbacher and glick ) . much of the effect is reported to result from lack of saliva volume (steinbacher and glick ) . interestingly, the presence of epilepsy may be associated with higher caries rates (anjomshoaa et al. ) . fluoride is an effective antimicrobial agent that interferes with bacterial growth and metabolism (wiegand et al. ) . hence, topical fl uoride administration as well as ingestion of fl uoridated water inhibits cariogenesis and caries progression (ripa ) . amelogenesis is a key process involved in modifying the rate of caries formation. both common variation and rare mutations in enamel formation genes such as amelogenin and enamelin are involved in caries rates (patir et al. ; kim et al. ; crawford et al. ) , the molecular actions of which are beginning to be revealed (lakshminarayanan et al. ) . over , new cases of cancers affecting the oral cavity and pharynx were expected in the united states for , with deaths numbering , (jemal et al. ) . the majority of these malignancies involved solid tumors originating from cancerous changes in squamous cells of the mouth. again, oral cancers have a complex etiology existing of entangled genetic, epigenetic, infectious, and dietary causes, further modifi ed by tobacco, alcohol and other environmental exposures. as with most cancers, it is reasonable to expect that both germline and somatic genetic changes will be involved in carcinogenesis, tumor growth, and metastasis. promoter hypermethylation of genes central to cellular growth, differentiation, dna fi delity, apoptosis, and metabolic stability is an important facet of these cancers (poage et al. ) . indeed, methylation-mediated silencing of genes involved in tumor suppression (e.g. the cyclin-dependent kinase inhibitor a), detoxifi cation (e.g. mgmt ), and apoptosis (e.g. the death-associated protein kinase- ) are commonly found in oral squamous cell carcinoma samples (ha and califano ) . to quantify the proportion of the variance in a phenotypic trait that is due to variance in genetic factors, population geneticists defi ned the concept of heritability (visscher et al. ; falconer and mackay ) . researchers subsequently developed several methods for estimating heritabilities using the measure of a trait (e.g. occurrence of disease/not-disease) in combinations of relatives (e.g. parentoffspring, or monozygotic-dizygotic twins). in general, the higher the measured heritability of a variable phenotype, the larger the contribution of genetic factors is in comparison to environmental effects. it is fallacious to assume that the heritable variation is composed entirely of alleles residing in the dna sequence, for heritability studies simply examine the covariance between relatives without comment on specifi c molecular mechanisms. hence, any heritable variation such as methylation patterns, vertically-transmitted infectious agents, as well as dna variation can contribute to the heritability measure. heritability results are important because they not only give a rough estimate of the collective effects of heritable factors, but also can provide a measure to quantify how much of the total genetic effect is accounted for by specifi c loci examined. for periodontal disease, four twin-based studies of heritability have been performed (michalowicz et al. ; corey et al. ; michalowicz et al. ; mucci et al. ) . although varying in sample size and methodological details, all four arrived at consistent results, with - % of the variance in periodontal disease being attributed to genetic variability for chronic periodontitis. given the segregation patterns described in the literature, it is reasonable to assume that aggressive periodontal disease exhibits a higher heritability. therefore, given the prevalence of periodontal disease, heritable factors within the population at large are likely appreciable. using twin pairs, bretz and colleagues reported substantial heritability values for multiple traits related to caries ranging from % to % (bretz et al. a, b ) . lastly, mutagen sensitivity studies of head and neck cancer patients suggest a signifi cant effect of genetic factors for the carcinogenesis of oral cancers (cloos et al. ) . hence, there is every reason to believe that a sizable pool of genetic and/or epigenetic factors await discovery for oral diseases. once the development of pcr (saiki et al. ) was applied to the idea of using naturally-occurring dna variation (botstein et al. ) , large-scale dna-based studies of disease underwent a substantial acceleration (schlotterer ) . genotyping of short, tandem repeated sequences (weber and may ) -microsatellites -spurred on a wave of genome-wide linkage studies, which evaluate the co-segregation of disease state with microsatellite markers, for both rare mendelian disorders as well as more common diseases with complex inheritance patterns. while the rarer traits with more coherent transmission patterns generally relinquished their genetic secrets to linkage analysis, more common diseases did not. in the mid-to late s, several theoretical studies had shown that the power to detect disease-causing alleles is higher with association-based designs such as a case/control experiment or association in the presence of a linkage signal as in the transmission/disequilibrium test if the frequency of those alleles is high and the effects are moderate (kaplan et al. ; risch and merikangas ; jones ; long and langley ) . however, to conduct genomewide association studies presented an ominous obstacle for the genetic technologies at the time. the number of markers required to effectively cover the genome was prohibitively large as the chromosomal blocks in population-based samples used in association designs were expected to be small. even within large extended families, the limited number of recombination events generates substantial chromosomal blocks passed through the pedigree, but researchers had both theoretical and empirical evidence that the blocks in population-based samples were on the order of k base pairs for most large human populations. as the reader can imagine, the mean length of blocks that are shared by descent is inversely related to the product of recombination rate, the number of affected individuals and the number of meioses separating the affected individuals. in practice, even very large extended families segregate regions shared by affected members on the order of several million base pairs in length. however, once geneticists seriously considered large-scale studies using a case/control design where individuals are separated by say , meioses, it became clear that to adequately cover the much smaller shared regions across the entire genome, hundreds of thousands of markers would be required (kruglyak ) . utilizing the human genome sequence (venter et al. ; lander et al. ) , a number of studies at celera diagnostics provided an intermediate solution, where approximately , putative functional snps primarily located in genes were assayed through allelespecifi c pcr in a number of common diseases using a staged case/control design. these studies were successful in identifying several gene-centric polymorphisms associated with common diseases (begovich et al. ; cargill et al. ) (fig. . ) . concurrently, several groups had performed extensive sequencing and genotyping across the genome to produce a genome-wide map of haplotype structure (hinds et al. ) , useful in linkage disequilibrium mapping. within years, technology for snp hybridization arrays had advanced so as to enable genome-wide association studies capable of capturing most of the common genetic variation in the genome either through direct genotyping or indirect interrogation using linkage disequilibrium -the term linkage disequilibrium is a measure of the correlation of alleles at closely-linked sites (see fig. . ). these investigations were met with numerous successes (klein et al. ; kathiresan et al. ; graham et al. ; gudmundsson et al. ) . inexpensive genotyping platforms and urging from theoreticians ensured that these genome-wide association studies were, in general, highly powered to detect all but very mild effects from high frequency alleles. these efforts, led by large academic consortia such as the wellcome trust, the international multiple sclerosis genetics consortium, and the broad institute and commercial entities such as decode genetics and perlegen have greatly expanded our understanding of the basic biology of common diseases: we now know, for example, that (i) autophagy-related genes are involved in crohn's disease (rioux et al. ) , (ii) there are a number of genes such as the protein tyrosine phosphatase, ptpn and the interleukin- receptor, il r , that exhibit ample pleiotropic effects among autoimmune conditions (lopez-escamez ; safrany and melegh ) , (iii) in the case of age-related macular degeneration, predictive models using the genetic results enable fairly accurate prognosis of individuals who are at high risk of disease (seddon et al. transcription factor tcf l plays a role in type diabetes (grant et al. ) , and (v) aberrant il- signaling likely contributes to multiple sclerosis susceptibility (gregory et al. ) . the plot shows the tremendous progress in genotyping technology where, a decade ago, very little of the genome was accessible for disease studies using association designs through the current wave of viable sequencing-based whole exome studies ( ) ( ) and whole genome studies ( ) ( ) . in fig. . , the average distance between adjacent genetic markers is plotted as a function of year of introduction to the disease mapping community. impressively, the total number of genetic markers has increased a million-fold over the past decade. although successful in uncovering numerous pathogenic pathways for common diseases, results from the current wave of genome-wide association studies, with a few exceptions, explain little of existing disease heritability. the reasons for this are cryptic and the subject of heavy debate (manolio et al. ) . multiple rare sequence variants generating high levels of allelic heterogeneity, functional de novo mutations, structural mutations such as copy number variants and large deletions, and epigenetic effects constitute four of several possible disease models that could account for the heritability discrepancy. the answer will almost certainly consist of a conglomeration of these and other effects. bringing forth the new genome-wide technologies that illuminate these previously non-or under-interrogated properties of the genome to bear on this enigma is a reasonable next step for all complex traits including oral diseases. the most commonly used measure of ld in a sample of chromosomes is linkage disequilibrium (ld) is a measure of the correlation between alleles at two sites in a sample of chromosomes. for two biallelic sites, if the a allele is always paired with the b allele, and the a allele is always on the same haplotype as the b allele, then the two sites are said to be in perfect ld. successive recombination diminishes ld. interrogating one site for disease association allows investigators to indirectly interrogate other sites in sufficiently high ld with the interrogated site. a key feature explicitly studied in molecular population genetics and implicitly used in disease gene mapping studies is the site frequency spectrum; that is, the distribution of allele frequencies at single sites in the genome that vary in the human population studied. from both diffusion models (kimura ) and coalescent theory (hudson ) in theoretical population genetics, we know that the vast majority of realistic models generate many more rare variants compared to common polymorphisms. this is particularly true for expanding populations. are these rare variants the source of much of the missing heritability? recently, with the application of high-throughput sequencing technology to human studies over the past decade, empirical studies have clearly verifi ed these predictions -the large majority of variants have low frequencies (the international hapmap consortium ) . the distribution of deletions appears to be skewed toward more rare frequencies, presumably due to the deleterious effects of such variants. individual mutations appearing de novo typically are extremely rare events per locus, but collectively are numerous. other types of genetic variability, such as copy number repeats, span both ends of the frequency spectrum with the preponderance of the markers being rare. thus, there is a sizable pool of low-frequency variants in human populations that have yet to be thoroughly investigated. over the past few years it has become increasingly clear that structural variants exist in the human genome at a far higher rate than previously thought. structural variants can exist in a multitude of forms including deletions, copy number variants, and inversions among others. due to the nature of these genetic changes, many are considered to be highly disruptive of molecular function if they lie in functional motifs. indeed, there are several mendelian diseases are caused by fully-penetrant structural variants impacting a chromosomal region (lupski ) . numerous structural variants have recently been reported to be associated with common diseases, particularly in the neurological fi eld (sebat et al. ; stefansson et al. ; elia et al. ) , infectious disease susceptibility (gonzalez et al. ) , and drug metabolism (zackrisson et al. ) . although they have improved dramatically over the past few years, algorithms using snp-based data from hybridization arrays to infer copy number variants have had high error rates, perhaps explaining the rather low rates of replication of structural variation association results for common diseases. nevertheless, given the high frequency of structural variants, their pathogenic potential, and that we are on the precipice of a sequencing revolution in genome-wide studies, examination of these variants should be a high priority for new sequencing-based studies in oral disease susceptibility, progression, and related pharmacogenetic applications. as different technologies examine different portions of the site frequency spectrum (i.e. genome-wide snp scans interrogate variation that is common in the hapmap populations, whereas sequencing-based studies typically interrogate the entire frequency spectrum), where one believes genetic causation is harbored should infl uence the selection of genotyping technology. if common genetic variation contains the vast majority of heritable effects on disease phenotypes, then an investigator would be wise to employ a snp-based experimental design. if, however, there is reason to believe that a signifi cant portion of the genetic load of the disease studied exists in the highly populated portion of the distribution -the rare variants -then a sequencing-based study may be better suited to unravel causative alleles. the studies of heritability discussed previously show that there is heritable variation underlying a substantial portion of the variance observed in oral diseases. as discussed above, sequencing technologies may address many aspects of dna variation including copy number loci, rare haplotypes, inversions, and insertions/deletions, but it is also worthwhile to repeat that the molecular mechanisms for disease heritability are not necessarily limited to variation at the dna level. for a disease state, the covariance between relatives could be driven by co-inherited chromosomal regions or other phenomena. chief alternative heritable mechanisms include dna methylation (hammoud et al. ) , modifi cations to the histones (bestor ) , complex rna zygotic transfer (rassoulzadegan et al. ) , and vertical transmission of infectious agents. additionally, transgenerational effects offer an intriguing class of epigenetic mechanisms (nadeau ) . in a thorough review on epigenetics and periodontitis, gomez et al. make a strong argument for consideration of both cpg dinucleotide methylation and deacetylation actions on cytokine expression as a credible avenue for further investigation in periodontal disease etiology (gomez et al. ) . genome-wide epigenetic studies have been successfully conducted for oral cancers (poage et al. ) . the scale of this study on head and neck squamous cell carcinomas allowed these researchers to show a global pattern of tumor copy number changes signifi cantly correlated with methylation profi les that was not detectable at the individual gene promoter level. with advanced chromatin immunoprecipitation and new methods to study dna methylation, efforts to apply highthroughput epigenetic methods to oral diseases should be accelerated. numerous studies have been conducted in oral disease traits using a candidate gene approach. there are two large reviews of the existing candidate gene results (nikolopoulos et al. ; ) . laine and colleagues have recently put together a comprehensive review article covering gene polymorphisms. there are some suggestive fi ndings for cyclooxygenase- gene, cox- , the cytokineencoding genes, il and il b , the vitamin d receptor, vdr , a polymorphism immediately upstream of cd , and the matrix metalloproteinase- gene, mmp . however, these initial results will require further confi rmation, for the association patterns are inconsistent across independent studies, the statistical signifi cance is moderate, and the posterior probability of disease is decidedly bland. the striking pattern that emerges from the laine et al. summary data is the lack of coherent replication of genetic association for the vast majority of polymorphisms examined. the situation is reminiscent of genetic association studies prior to large-scale snp studies where poor repeatability of results plagued the fi eld. in a pivotal study from , hirschhorn and colleagues (hirschhorn et al. ) examined the state of genetic association studies, fi nding that "of the putative associations that had been studied three or more times, only six have been consistently replicated." the dearth of robust results was largely remedied when large-scale genetic studies were applied to very substantial numbers of well-characterized patients and geneticallymatched controls and stringent statistical criteria enforced. one can only suspect that a similar state of affairs is operating in genetic studies of chronic periodontitis. perhaps efforts to ( ) reduce the heterogeneity of the disease state through detailed clinical and laboratory assessments, ( ) drastically increase sample sizes, and ( ) expand the scope of inquiry to larger numbers of genes/regions, and examine a more comprehensive set of variants/epigenetic effects will improve the current situation. the second large study is a meta-analysis of studies, where nikolopoulos and colleagues analyzed six cytokine polymorphisms linked to il a , il b , il , and tnf-alpha (nikolopoulos et al. ) . two of these, an upstream snp in il a and a snp in il b , exhibited signifi cant association with chronic periodontal disease risk. although the results were not particularly strong, as is typical with complex diseases, the results do suggest the importance of infl ammation-response variability in chronic periodontitis predisposition. perhaps the strongest, most replicable genetic association fi nding with coronary heart disease and myocardial infarction is centered on the short arm of chromosome ( p . ) (mcpherson et al. ; helgadottir et al. ) . two studies of periodontal disease showed that the same alleles at the p . locus confer risk for aggressive periodontitis (schaefer et al. ; ernst et al. ) . the discovery of such a pleiotropic locus may explain a portion of the aggregation of periodontal disease with other co-morbid conditions. further studies investigating overlapping genetic susceptibility factors between periodontitis and cardiovascular disease, diabetes mellitus, metabolic syndrome, rheumatoid arthritis, and other related diseases may be a fruitful strategy for honing in on shared genes affecting these immuno-metabolic disorders. using patients from families from the philippines, the fi rst genome-wide linkage study for caries was completed in (vieira et al. ) . the study identifi ed fi ve loci which exhibit suggestive statistical evidence (lod scores exceeding . ): q . , q . , xq . , q . , and q . . the latter of which overlapped with a quantitative trait locus discovered from mapping work in the mouse. further work is necessary to refi ne these signals and localize the variants that may be driving these linkage signals. aggressive periodontal disease and rarer dental diseases have also been subjected to linkage analysis. results from linkage studies for dentinogenesis imperfecta type i, for example, have gone on to produce the novel gene fi ndings of the dentin sialophosphoprotein-encoding gene on q . being responsible (song et al. ; crosby et al. ) . a linkage study in african american families examining localized aggressive periodontitis found a strong linkage signal in a region covering approximately megabases on chromosome (li et al. ) . several interesting genes are in this region. in a study earlier this year further mapping from carvalho et al. in brazilian families identifi ed haplotypes in this region on q in fam c which were associated with aggressive periodontitis (carvalho et al. ) . the function of the fam c protein is not fully understood. fam c is localized in the mitochondria and it appears to play a role in vascular plaque dynamics and risk of myocardial infarction (laass et al. ) . it should also be noted here that other types of mapping analyses such as homozygosity mapping to identify have yielded gene discoveries. for example, the lysosomal protease cathepsin c gene for the recessively-inherited papillon-lefevre syndrome which is characterized by aggressive and progressive periodontitis was effectively mapped using homozygosity mapping (fischer et al. ; connelly et al. ) . cathepsin c is highly expressed in leukocytes and macrophages and is a key coordinating molecule in natural killer cells (rao et al. ; meade et al. ) . although sparse, these linkage results are undoubtedly encouraging. employing very large extended families subjected to genome-wide genotyping or sequencing will surely shed much needed light on chromosomal regions and genes relevant to oral disease research (fig. . ). for periodontitis, a single study has employed a genome-wide association design in an effort to uncover aggressive periodontal variants (schaefer et al. ) . this study by schaefer and colleagues discovered and replicated an intronic snp, rs , in the glycosyltransferase glt d which is signifi cantly correlated with aggressive periodontal disease in both german and dutch samples. often, seemingly signifi cant results from large studies are due to the effect of reporting the top result from a great many statistical tests -this is called the multiple testing problem. in this situation, the strength of the fi nding, along with the replication across three case/control studies, argues for true association with aggressive periodontal susceptibility. the snp may modulate the binding affi nity of gata- . the association with glt d is currently one of strongest genetic associations for aggressive periodontal disease, testifying to the power of genome-wide studies to generate novel, relevant molecular pathophysiology for complex diseases. it seems unlikely that glt d would be extremely high on a candidate gene list, and it was only through a genome-wide scan that it appeared. like many excellent studies, the fi nding by schaefer et al. raises more questions than it answers and will undoubtedly provide fertile ground for ensuing molecular work. after a somewhat sluggish start, due to a lack of critical mass of investigators aiming to collect large numbers of patient samples and bring high throughput genetic technologies to caries susceptibility, gingivitis, and periodontal disease traits, the future of genetic studies in oral health is bright. scientifi c progress in revealing the molecular pathogenesis of oral diseases is dependent on genome-wide genetic studies; and i have argued that progress in related immuno-metabolic diseases is also dependent on these large-scale genetic studies in periodontal disease. to study sporadic disease, substantial patient collection efforts are required for the application of these technologies. this may involve a combination of new recruitment and consortiumrelationships with existing collections. the beginning of such a collection for sporadic aggressive periodontitis in europe has shown extremely intriguing initial results, but more patients are needed to examine rare variants of moderate effect. both the german/dutch collection of aggressive periodontitis and the brazilian collection have begun to revolutionize the study of periodontal disease susceptibility with the discovery of glt d snps and fam c -linked haplotypes. there is little doubt that subsequent molecular work on these two genes will uncover novel mechanisms for the predisposition to aggressive periodontal disease. focus should also be placed on the collection of extended families segregating these diseases. applying sequencing technologies to large pedigrees can be an effective method of identifying rare variants and structural variants in a highly-refi ned phenotype. furthermore, applying these methods to the entire genome would make for a comprehensive genetic study. several trends in large-scale genomics science hold promise to signifi cantly advance our understanding of oral disease pathogenesis: the sociology of biological sciences has changed over the past years so as to • become more collaborative. essential for association-based designs, consortiumbased genetic research has blossomed over that time period, increasing sample sizes and therefore the power to detect disease-causing variants. there currently is consortium-based research in periodontal disease and oral cancer. further expanding these efforts will enhance subsequent studies, particularly those investigating rare alleles and/or rare epigenetic effects. through over a century of laboratory work, the collective knowledge of bio-• chemical pathways, signal transduction, cell physiology, regulatory mechanisms, and structural biochemistry is weighty. incorporation of this information into etiological models may substantially advance oral disease work as well as the fi eld of complex disease genetics in general. sophisticated analysis techniques are needed to perform this task. recent advances merging results from network science with probability theory within the context of computer science have produced the fi eld of machine learning. this rigorous framework can be used to identify those factors responsible for disease status and can also be used to develop robust predictive models using known biological networks and genetic data. the output from such models, typically the probability of disease, an estimate of disease progression rate, or a probability of adverse reaction, can be used by physicians and dentists to personalize medical care. until relatively recently, population genetics did not contribute a great deal to • human genetics research. that has changed in the past decade where effort spent on association studies surpassed that spent on family-based studies. those investigating disease gene mapping began to collaborate with population geneticists and population geneticists took up a wide-spread interest in fi nding disease alleles. incorporation of population genetics theory into such studies markedly improved association studies on several levels: confounding by population stratifi cation was effectively treated using population genetics, linkage disequilibrium patterns. use of population genetics theory in large-scale oral disease mapping studies may accelerate discoveries. sequencing technology has rapidly progressed over the past decade. currently, • sequencing studies across the exome can be accomplished at reasonable cost and yield data for all known genes in the genome. within the next few years, sequencing costs will depreciate to a point where whole-genome sequencing studies will be commonplace, using both family-based and population designs. application of these technologies to oral disease studies is imperative for comprehensive studies of etiology. high-throughput dna methylation and chromatin immunoprecipitation studies • will enable large-scale epigenetic studies in oral diseases (meade et al. ; ehrich et al. ; bibikova et al. ; ren et al. ; pokholok et al. ) . these have already started to play an important role in delineating mechanisms responsible for oral cancers (poage et al. ) . additional application of these techniques to studies of gingivitis, caries, and periodontal diseases may generate novel fi ndings. molecular biologists and pharmacologists have increasingly become able to • develop and evaluate highly targeted pharmaceuticals based on genetic discoveries. the use of such genetic information may improve the chances of developing effi cacious therapies. geneticists and disease researchers are beginning to realize that oral diseases • both impact and are intrinsically tied to susceptibility and progression of other common diseases. a synthesis of genetic fi ndings from immuno-metaboliclinked disorders would seem to greatly increase the knowledge of these diseases and better pinpoint their respective etiologies. as the new high-throughput genomics and epigenomics technologies become • implemented in oral disease research, the storage, management, analysis, and interpretation of the ensuing colossal amounts of data will be critical to enable clinicians to use these results in daily practice. advances in dental and medical informatics will facilitate these steps. we are in exciting times where advances in genetic technologies will uncover the genetic causes of diseases, including those that affect the oral cavity. with more focus in the area of oral disease genomics and the harnessing of new high-throughput sequencing and epigenetic technologies, novel insights into the pathways driving these diseases are imminent. these discoveries will, in turn, motivate directed therapies, aid in illuminating the molecular etiology of related disorders such as diabetes, and increase the level of personalized medicine. joseph kilsdonk the title of this section reinforces a institute of medicine (iom) report titled "dental education: at the crossroads." to quote yogi berra, a baseball sage: "when you come to a fork in the road, take it." the implication being that dental education must take action and move beyond its crossroads. these crossroads are described in the fi rst third of the section. it includes a summary and recommendations of the iom report and three transitional reports that followed: the surgeon general's report identifying oral health as a silent epidemic, the josiah macy foundation report, and a "pipeline" study funded by both the robert wood johnson and the california foundations. having been at the crossroads for a decade or so, the middle portion of the section highlights educational models that may lead to a more promising future. the later third of this section describes an alternative path of action for dental education which emphasizes the central roles of clinic-based education and dental informatics in dental education curriculum. it is unknown how traditional dental educators may view this model; however, it is effectively a logical conclusion and responsive to the reports. in the institute of medicine (iom) published "dental education at the crossroads" (field ) . the title was apropos as the authors' analysis concluded: ( ) economics surrounding dental education were unsustainable ; ( ) student service learning opportunities and access to care for patients were limited; and ( ) new dental schools were not replacing those forced to close due to the economic climate. the iom report additionally proposed key recommendations to reform dental education and service delivery. fifteen years later, we remain at "the crossroads" as these issues remain largely unresolved. furthermore, these recommendations have retained their validity. their implementation would directly impact structures and services for contemporary models of dental education in the future. the following iom recommendations (field ) are intrinsic to the proposed dental education reform: recommendation : to increase access to care and improve the oral health status of underserved populations… recommendation : to improve the availability of dental care in underserved areas and to limit the negative effects of high student debt… recommendation : to prepare future practitioners for more medically based modes of oral health care and more medically complicated patients, dental educators should work with their colleagues in medical schools and academic health centers to: move toward integrated basic science education for dental and medical • students; require and provide for dental students at least one rotation, clerkship or • equivalent experience in relevant areas of medicine and offer opportunities for additional elective experience in hospitals, nursing homes, ambulatory care clinics and other settings; continue and expand experiments with combined md-dds programs and • similar programs for interested students and residents; increase the experience of dental faculty in clinical medicine so that they, • and not just physicians, can impart medical knowledge to dental students and serve as role models for them. recommendation : to prepare students and faculty for an environment that will demand increasing effi ciency, accountability, and evidence of effectiveness, the committee recommends that dental students and faculty participate in effi ciently managed clinics and faculty practices in which the following occurs: patient-centered, comprehensive care is the norm; • patients' preferences and their social, economic, and emotional circumstances • are sensitively considered; teamwork and cost-effective use of well-trained allied dental personnel are • stressed; evaluations of practice patterns and of the outcomes of care guide actions to • improve both the quality and the effi ciency of such care; general dentists serve as role models in the appropriate treatment and referral • of patients needing advanced therapies; larger numbers of patients, including those with more diverse characteristics • and clinical problems, are served. recommendation : because no single fi nancing strategy exists, the committee recommends that dental schools individually and, when appropriate collectively evaluate and implement a mix of actions to reduce costs and increase revenues. potential strategies, each of which needs to be guided by solid fi nancial information and projections as well as educational and other considerations, include the following: increasing the productivity, quality, effi ciency, and profi tability of faculty • practice plans, student clinics, and other patient care activities; pursuing fi nancial support at the federal, state, and local levels for patient-• centered predoctoral and postdoctoral dental education, including adequate reimbursement of services for medicaid and indigent populations and contractual or other arrangements for states without dental schools to support the education of some of their students in states with dental schools; rethinking basic models of dental education and experimenting with less • costly alternatives; raising tuition for in or out-of-state students if current tuition and fees are low • compared to similar schools; developing high-quality, competitive research and continuing education • programs; consolidating or merging courses, departments, programs, and even entire • schools. in summary, the iom report identifi ed that: ( ) an outdated curriculum continues to be retained which refl ects past dental practice rather than current and emerging practice and knowledge; ( ) clinical education does not suffi ciently incorporate the goal of comprehensive care, with instruction focusing too heavily on procedures; ( ) medical care and dentistry are not integrated; and ( ) the curriculum is crowded with redundant material, often taught in disciplinary silos. the iom's report was followed by the surgeon general's report on oral health in and a subsequent supplement by the surgeon general in called "the national call to action" (u.s. department of health and human services ) . five signifi cant fi ndings and recommendations from the surgeon general's report(s) that have implications pertaining to the envisioned structure and services of new models for dental education include: changing the perception of oral health so that it will no longer be considered • separate from general health; improving oral health care delivery by reducing disparities associated with popu-• lations whose access to dental treatment is compromised by poverty, limited education or language skills, geographic isolation, age, gender, disability, or an existing medical condition; encouraging oral health research, expanding preventive and early detection pro-• grams, and facilitating the transfer of knowledge about them to the general population; increasing oral health workforce diversity, capacity, and fl exibility to overcome • the underrepresentation of specifi c racial and ethnic groups in the dental profession. in this regard, the national call to action urged the development of dental school recruitment programs to correct these disparities and to encourage parttime dental service in community clinics in areas of oral health shortage; increasing collaboration between the private sector and the public sector to cre-• ate the kind of cross-disciplinary, culturally sensitive, community-based, and community-wide efforts to expand initiatives for oral health promotion and dental disease prevention. spurred by the iom report and the surgeon general's report, the josiah macy foundation ( ) conducted a study entitled "new models of dental education." the study was prompted by concerns about declines in dental school budgets and the diffi culties experienced by schools in meeting their educational, research, and service missions. the macy study concluded that: financial problems of dental schools are real and certain to increase. • current responses of schools to these economic challenges are not adequate. • most promising solutions require new models of clinical dental education. • macy study lead researcher dr howard bailit, and his team recently concluded in reference to points one and two above, that: "if current trends (to aforementioned) continue for the next years, there is little doubt that the term crisis will describe the situation faced by dental schools. further, assuming that it will take at least ten or even more years to address and resolve these fi nancial problems, now is the time for dental educators, practitioners, and other interested parties from the private and public sectors to come to a consensus on how to deal with the coming crisis. clearly, these fi nancial problems will not be solved by minor adjustments to the curriculum, modest improvements in the clinical productivity of students or faculty, or even signifi cant increases in contributions from alumni. the solutions 'must involve basic structural changes in the way dental education is fi nanced and organized' (bailit et al. ) ." this statement is supported by the fact that in the past years more dental schools have closed than opened. specifi cally eight schools have closed, whereas to date a couple has opened and a handful is pending. curriculum relevance was also a focus of the study. findings concluded that "changing the curriculums in dental schools to allow students to spend more time in community venues would be highly benefi cial to both society and student. society benefi ted from having underserved patients cared for while students were assessed as being fi ve to ten times more productive, more profi cient, more confi dent, more technically skilled and more competent in treating and interacting with minority patients" (brodeur ) . macy study (formicola et al. ) outcomes represented signifi cant and foundational guideposts for assessing and planning any future models for dental education. their report led to the robert wood johnson foundation pipeline study ( ) , a major research study funded by the robert wood johnson foundation and the california endowment (tce). the goal of the dental pipeline program was to reduce disparities in access to dental care. the pipeline study provided over $ million for the start up or expansion of schools and student clinical programs that incorporated services to underserved extramural clinical settings (primarily community health centers). the following recommendations from the surgeon general's report structured • the goals of the pipeline's initiative: increase the number of under-represented minority and low-income students enrolled in the dental schools participating in the pipeline program so that there would be a voice of minority and low-income students at all the funded schools. provide dental students with courses and clinical experience that would prepare • them for treating disadvantaged patients in community sites. have senior dental students spend an average of days in community clinics • and practices treating underserved patients. increasing the community experience of dental students was expected to have an immediate impact on increasing care to underserved patients (brodeur ) . this third point is pivotal to future success of dental curricula and dental education economics. recently published in a supplemental volume to the journal of dental education , february, , the pipeline study reported the following outcomes: minority recruitment of low-income students increased by %; • the rate of recruitment for under-represented populations was almost twice that • of non-pipeline schools; the length of time dental students spent in extramural rotations increased from a • mean of days to a mean of days over a period of years. procedural profi ciency increased compared to that of their non-extramural peers. of the pipeline-funded programs, only four schools achieved the goal of • days of extramural rotations; through extra funding from tce, the four schools extended extramural rotations to an average of days; based on this publication, it appears that only a handful of pipeline schools defi -• nitely plan to sustain their extended extramural rotations. financial concerns were highlighted as the major problem in sustaining future recruitment and placement of students beyond the timeframe of the study; a survey of program seniors indicated a mean of % [range of - % by • school] were planning to devote ³ % of their practice to serving minority patients. only % [range of - % by school] were planning to practice at community clinics. in the context of these outcomes, discussion indicated that the unwillingness of students to practice in underserved settings was based on several factors: students that participated were already enrolled in traditional programs and were • not necessarily seeking a pipeline experience or a future in community service. concern over future reimbursement as a provider in a community setting; • limited time spent in underserved settings; • limited loan forgiveness scholarship opportunities. • the fact that the large majority of pipelines were unsustainable was attributed to lack of productivity in the school clinics while the students were on rotation at community based clinics. schools generate meager, yet necessary revenue streams on intramural student clinical activity to support the costly clinical and faculty infrastructure. currently, similar economic constraints involved with outsourcing students to serving rural and underserved populations impacts the ability of tradition dental schools to participate in sustained outreach programs. most recently, the pew center on the states national academy for health policy ( ) released "help wanted: a policy makers guide to new dental providers". this report provided an excellent summary outlining workforce needs, access issues, and strategies for dental-related services to help states and institutions develop creative ways to solve oral health access and care issues. the guide proposes the following relevant components and trends for consideration in development of future sustainable school models: dental colleges are willing to bear a large and disproportionate share of the burden • in terms of access to care, particularly during a time of incredibly scarce resources. expanded, extensive, and/or creative extramural rotations have been developed • in recent years under the conceptual umbrella of service-learning. these often involve clinics providing direct or indirect payment to dental schools or clinics managed in some way by dental schools. dental education has certain obligations. first, education must adhere to accreditation standards with the goal of producing competent practitioners. second, education must remain responsive and impact the societal need for care. lastly, the delivery of dental education must be economically sustainable. the macy, rwjf, and iom reports note that improved oral health, sustainable dental education economic models, and competent workforce pipelines converge around community health centers (chc). university of michigan researchers fitzgerald and piskorowski ( ) reaffi rm this conclusion in an evaluation of an ongoing -year program, stating that: (the chc model) is self-sustaining and can be used to increase service to the underserved and increase the value of students' clinical educational experiences without requiring grant or school funding, thus improving the value of dental education without increased cost. self-sustaining contracts with seven federally qualifi ed health centers (fqhcs) have resulted in win-win-win-win outcomes: win for the underserved communities, which experienced increased access to care; win for the fqhcs, which experienced increased and more consistent productivity; win for the students, who increased their clinical skills and broadened their experience base; and win for the school in the form of predictable and continuing full coverage of all program costs (fitzgerald and piskorowski ) (fig. . ). however, unlike medicine that outsources their students to clinical sites, dental education programs retain the majority of the student time within their own "clinical laboratories" as documented by the aforementioned studies, this limits students' exposure to extramural experiences. costs to operate such intramural clinical programs are ever increasing and many schools' clinical operations run defi cits. if that component can be outsourced to community-based resources such as a chc, then the burden of cost is shifted away from the school. an example would be a.t. still university's arizona school of dentistry and oral health (asdoh) which matriculated its fi rst class in . at the prompting of the state's community based clinics, asdoh designed a program that placed students into community-based settings for up to months, an unprecedented length of time for an extramural rotation. they also saw this as an opportunity to use an adjunct centric faculty that signifi cantly reduced traditional education overhead. through this innovation, the school was able to develop a program that was sustained by "fair market" value tuition and trained students where community needs were greatest for up to months (which was then unprecedented). conversely, if the chc can rely on student service-learning to care for patients, the cost of care is reduced. other schools are also advancing with innovative education and care delivery. adea's charting progress (valachovic ) fig. . the synergy between access to care, student competency, and fi nancially sustainable dental education converge around chc/fqhcs little rock, arkansas; and the university of southern nevada in south jordan, utah. western university is planning placement of % of their fourth year class in community health centers, while east carolina is seeking to set up rural clinical campuses as well as clinical partnerships with the state's fqhc. at the time of this publication, several existing schools are expanding or looking to expand including the university of north carolina, marquette university, midwestern university in downer's grove, il. such expansions will contribute to solving the existent access supply and demand issues. however, it was observed even with all the start ups and expansions, graduation numbers will not approach the output of schools in the late s and early s. these creative models establish the foundation for a sustainable clinic structure by generating self-sustaining revenue through student service-learning, which, unlike medical student services, are billable. simultaneously these new models provide access to care for the needy while student exposure to clinical experiences that are often not available in academic patient pools. these models also shift some of the cost of providing clinical education from the dental college to community-based clinics. however, this innovation is not without criticism. schools are dependent on the success of their clinics and clinic partnerships. one author cautions: "however, these creative models also may present potential political strategic risk or confl ict: private practitioners may organize and protest higher than normal reimbursement schemes. potentially, such protests could even jeopardize the very existence of such models (dunning et al. ) ." notably, community health centers have historically received strong bipartisan support. for example, during the bush administration, fqhc funding was doubled and most recently expanded through health reform legislation by the obama administration. according to the institute for oral health, "the group practice of the future is the dentist working with the physician" (ryan ) . the ada reported "multidisciplinary education must become the norm and represent the meaning and purposes of primary care as it applies to dentistry. educational sequences should include rotation strategies across discipline specialties in medicine and dentistry, clerkships and hospital rotations, and experience in faculty and residency clinics." (barnett and brown ) the models alluded to, were school-based attempts at improving educational outcomes. perhaps the proverbial fork in the road regarding the future of dental education leaves two paths for consideration. is it better to travel down a road that leads a school to develop and operate a clinic? or is the road less traveled, where a clinic becomes a school, the better of the two options? the answer, perhaps, is that a combination of both will accomplish the desired outcome. for example, didactic knowledge is measured by examination whereas competency as a practitioner is measured by clinical demonstration. at a minimum, the result must achieve learner competency, quality, and sustainability. however, the road less traveled has not been taken yet. william gies, in his revered report written years ago on the state of american dental education, wrote "dental faculties should show the need…. for integrated instruction in the general principles of clinical dentistry and in its correlations with clinical medicine" (gies ) . basic sciences aside, could a clinicalbased educational training center have an advantage over a school-based clinical center? soon-to-be-implemented new commission on dental accreditation (coda) standards will require schools to demonstrate competency in patient-centered care (valachovic ) . might an enterprise profi cient at running a successful clinical business model have an advantage running a professional, patient-centered clinical training program as compared to a pedagogical business model attempting to run a clinical training model? these questions should challenge us to reexamine why our thinking about educational models should be limited to schools being the starting point for the development of a profession that demands clinical competency, patientcenteredness, and integration as outcomes. the clinic based model may serve as an equivalent starting point and, have some distinct advantages for achieving responsiveness to recommendations and directions cited in this section. beginning in november through august , the family health center (fhc) of marshfi eld, inc, marshfi eld, wisconsin, launched of a broad network of developing dental clinics, targeting dental professional shortage areas with the provision of dental services to the underserved communities whose dental needs were not being adequately met by the existing infrastructure. fhc-marshfi eld is a federally qualifi ed health center (fqhc). as an fqhc, fhc receives cost-based reimbursement for its dental services to medicaid populations. along with the cost-based reimbursement, fqhcs are obligated to provide care to anyone regardless of their ability to pay. presently, fhc is the nation's largest federally qualifi ed dental health center. to date, this network of dental clinics has served over , unique patients, % of whom were under % of poverty. notably, service was provided to a signifi cant number of cognitively and developmentally disabled patients in special stations developed for serving patients with special needs. these patients frequently travel the furthest to get to our dental centers for care. beginning in , fhc stepped up the pace of dental clinic expansion, constructing two new dental centers in , two in , and two more are slated to open in . when fully operational, this will establish capacity to serve , patients annually. each site has proactively included dedicated clinical and classroom training space for dental residents or students, thus laying the framework for clinic-based training of new dental professionals. the plan is to continue to stand up new dental centers until they have the capacity to serve , patients annually or approximately % of the , underserved patients in the rural service area. in addition to the capacity for training residents and students, a dental post-baccalaureate program is being considered in partnership with regional year under graduate campuses. the post-baccalaureate program is aimed at preparing students from rural and underserved areas who desire to practice in rural and underserved areas for acceptance and success in dental schools. presently fhc in partnership with marshfi eld clinic is moving forward with plans to develop dental residencies at these sites and a dental post baccalaureate training program to better prepare pre-doctoral students from rural and/or underserved backgrounds to be successful in dental school as a means to create a dental academic infrastructure responsive to rural environments which have been classically underserved. marshfi eld clinic has a long-standing history in medical student education and multiple medical residency programs. creating access for the underserved population was the major motivational force driving the establishment of the dental clinic network back in . the fi ndings of the iom, macy, and rwjf reports became the foundational framework for developing the vision of a dental education model that would realize the major recommendations found in the reports. by establishing clinical campuses in regional underserved dental health professional shortage areas, access to care where care is needed most was provided. sustainment of a work force for provision of care across the dental clinic network is accomplished by schools contracting with fqhc's for service learning, thus circumventing challenges associated with releasing dental students at traditional dental schools to distant extramural training sites as discussed previously. this model is however not without its own set of challenges including calibration of faculty, supervision and evaluation of students in training, and achieving accreditation acceptance. however, through video connectivity and iehr technology curriculum, learning plans, competency assessment, progression, performance, faculty development, and learner evaluations can be centrally calibrated. additionally, this dental service-learning model based in a community health center setting offers students unique state-of-the-art exposures to alternative access models, cutting-edge informatics (including access to a combined dental-medical record) and a quality-based outcomes-driven practice. given the novelty of such an extended extramural dental clinical training model, there is limited data on the success of rural placement leading to retention to practice in a rural setting. the pipeline study piloted a model for getting students into underserved communities. however, that experiment was limited to -day rotations. outcome driven programs may provide a predictive surrogate for purposes of comparative analysis. for example, the rural medical education "rmed" program of the university of illinois medical school at rockford, has sustained a longstanding program in illinois. over years in duration with over student participants of whom % have been retained as primary care medicine practitioners in rural illinois. rabinowitz et al. ( a ) further reinforced that medical school rural programs have been highly successful in increasing the supply of rural physicians, with an average of - % of graduates choosing to practice in rural areas. they also noted rural retention rates of - % among the programs (rabinowitz et al. a) . recently, the university of wisconsin school of medicine and public health (uwsmph) launched the wisconsin academy for rural medicine (warm program). the warm program places medical students in rural academic medical centers during their third and fourth years in medical school. marshfi eld clinic is one of those sites. warm students affi liating with marshfi eld clinic's system would ultimately share learning experiences with dental students, clinical rotations, team-based rounding, lectures, and exposure to a combined medical-dental patient record. in an analogous manner, the marshfi eld clinic dental education model will incorporate a curriculum that embeds students in rural clinical practice for up to years. a secondary but not insignifi cant outcome of placing residents and students in clinical campuses focused on developing competency and providing care where needs are often greatest is the cost savings to taxpayers associated with the public care of patients. these savings are accomplished through the "service-learning" of the student. for example, in the model described where clinical training is embedded within the fhc clinics, the stipend resident or unpaid student learner provides the patient care as part of their service learning training while requiring oversight from one paid faculty per four to six learners. as a result, an academic based clinical partnership creates a model that reduces the cost for care provided to underserved patients. an additional benefi t to the community based clinic might be realized through tuition assistance by the academic program to help support patient procedures that develop learner competencies. in educational quality and infl uence, dental schools should equal medical schools, for their responsibilities are similar and their tasks analogous (william gies ) . the commission on dental accreditation (coda) notes that one of the learning objectives of an advanced education general dentistry (aegd) residency is to have the graduate function as a "primary care provider". to function competently in this role, the graduate needs to have a strong academic linkage to primary care medicine. at a dental deans forum, years after the gies report, dr polverini made the statement "dentistry has never been linked to the medical network but unless dentistry becomes part of the solution to the challenge of providing comprehensive patient care, it will be looked on as part of the problem, and ultimately, all dental schools will be called into question." (polverini ) the use of dental informatics and an integrated record are elements essential to this competency. on april , , fhc and marshfi eld clinic successfully transitioned all of their dental centers to a new practice management and electronic health record system that fully integrates medical and dental; one of the fi rst such systems in the nation. along with the benefi ts derived in fig. . , chc placement also exposes students to an integrated medical-dental care setting where learners can develop skills in system-based practice to include the interdependence of health professionals, systems, and the coordination of care. on the administrative side, dental and medical appointments can be coordinated to enhance convenience for patients and improve compliance with preventive dental visits. in , marshfi eld clinic's research foundation biomedical informatics research center hired their fi rst dental informatician, dr. amit acharya, bds, ms, phd. with dedicated biomedical informatics and research resource centers, the marshfi eld clinic has laid the groundwork for true medical/dental integration with appropriate electronic health record decision support and is positioned to develop a dental education curriculum capable of implementing the iom recommendations. downstream benefi ts of using such a curriculum are the ability of future practitioners to use informatics to improve quality of care and reduce the burden of disease. according to an institute of oral health report ( ) it is widely accepted across the dental profession that oral health has a direct impact on systemic health, and increasingly, medical and dental care providers are building to bridge relationships to create treatment solutions. as early as , william gies recognized that "the frequency of periodic examination gives dentists exceptional opportunity to note early signs of many types of illnesses outside the domain of dentistry" (gies ) . the following examples show how integration of dental and medical care can impact patient outcomes, underlining the importance of this concept in dental curriculum design. a study of , blue cross blue shield of michigan (bcbs) members with diabetes, who had access to dental care lead researchers, and bcbs executives to conclude that treatment of periodontal disease signifi cantly impacts outcomes related to diabetes care and related costs (blue cross blue shield of michigan ) . another example is found in the context of preterm delivery and miscarriage. according to research cited by cigna ( ) , expecting mothers with chronic periodontal disease during the second trimester are seven times more likely to deliver preterm (before th week), and have dramatically more healthcare challenges throughout their life. cigna also cites the correlation between periodontal disease and low birth weights, pre-eclampsia, gestational diabetes. equally important is the opportunity to develop and implement the team-based curriculum that trains future dentists and physicians in the management of chronic disease as an accountable care organization (aco) in a patient-centered environment. as an example, joseph errante, d.d.s., vice president, blue cross blue shield of ma, reported that medical costs for diabetics who accessed dental care for prevention and periodontal services were signifi cantly lower than those who didn't get dental care (errante ) . these data suggest that team based case management of prevalent chronic health conditions have considerable cost savings opportunities for government payers, third party payers, employers and employees (errante ) . these economic benefi ts to integration as it relates to the iehr are discussed elsewhere in this book, but begin with the ability of providers to function in a team based environment and as such, underscore the importance of training in such an environment. dentists trained in a fqhc iehr integrated educational model will be well positioned to function successfully within an aco model. an aco is a system where providers are accountable for the outcomes and expenditures of the insured population of patients they serve. the providers within the system are charged with collectively improving care around cost and quality targets set by the payor. within this system, care must be delivered in a patient-centered environment. the patient-centered environment according to the national committee for quality assurance (ncqa), is a health care setting that cultivates partnerships between individual patients and their personal physicians and, when appropriate, the patient's family. care is facilitated by registries, information technology, health information exchange and other means to assure that patients receive defi ned, timely and appropriate care while remaining cognizant of cultural, linguistic and literacy needs of the patient being served. the model includes the opportunity to deliver patient care that is patient-centric, incorporates the patient in the care planning, considers the patient's beliefs and views, and incorporates the patient's families as needed. the model allows providers to deliver care that is inclusive of needs, attentive, and accessible. the model equips payers to purchase high quality and coordinated care among teams of providers across healthcare settings. while this describes the medical home, most dental practices also follow this process. many dental practices function in this regard with insured populations and refl ect elements of the model that medicine is creating. william gies would be proud. training in the delivery of accountable and patient-centered medical-dental care must be done purposefully. commenting on the inadequate training relative to the integration of medical and dental education, baum ( ) stated that "we need to design new curricula with meaningful core competencies for the next generation of dentists rather than apply patches to our existing ones." while this statement was made in reference to the basic sciences, the same holds true for patient-centered system-based practice competencies. utilizing state-of-the-art electronic medical records as a tool and the fhc infrastructure as the service venue, meaningful patient-centered system-based practice core competencies achievement becomes possible in a manner highly responsive to societal needs. by defi nition, fqhcs must provide primary medical care, dental care, and behavioral health. fqhc have also historically been utilized as healthcare workforce training centers and the affordable care act of reinforced their role as healthcare training centers. specifi cally, this legislation serves to promote fqhcs as the entity through which the primary care workforce (including dental) will be developed and expanded. in combination, fqhcs and primary care centers are positioned to be the front runners in a medical/-dental home training model which will be essential to preparing future practitioners for practice in an aco. critical to this success is the ability to train these practitioners on an integrated medical-dental record and informatics platform. use of this platform imprints most strongly during the learner's formative years of training; instructing and guiding disease management, decision making, patient care coordination, prevention, and both outcome-based and comprehensive care. training in this hybrid academically orientated clinically integrated setting moves dental education off its crossroads and creates the highway to its future. concerns with the new models extend to their ability to integrate medical and dental disciplines at the clinical and informatics level. while the iom report identifi ed the need to integrate medical and dental curriculum, success at the curricular and technological level within schools, has been limited. three major factors have contributed to the limited progress: access priorities. creating access to care has outranked the need to integrate • care. in part, this refl ects societal need for care and public demand to reduce the burden of the "silent epidemic." schools play an important role as a safety net to care for the uninsured and underinsured through intramural clinical service learning. even though "dental colleges seem to be willing to bearing a large and disproportionate share of the burden in terms of access to care" (dunning et al. ) , schools were challenged as part of iom, surgeon general, and macy reports, to expand that role. while these reports have prompted creative educational solutions to increase access, the reports understate the tremendous opportunity, quality and cost benefi ts that could result from an integration of medicine and dentistry. it is diffi cult to change the culture and structure of existing schools. this is not • unique to dentistry. however, the iom report specifi cally recommended that schools "eliminate marginally useful and redundant courses and design an integrated basic and clinical science curriculum". the challenges with this are many. examples include: some schools may not have other disciplines to draw from to create an inte-grated curriculum; a number of schools use a faculty senate to determine curriculum. this can result in curriculum that preserves the current faculty structure; changing curriculum is associated with expense and can be fi nancially pro-hibitive to some schools physical changes may be needed and represent an expense and/or may, in some instances, may not be practicable based on structure of existing facilities. public school programs may direct the fi nal curriculum, as boards or regent's one or two steps removed from the curriculum often have fi nal authority conversely, private schools may specify business or mission objectives that determine fi nal design. perhaps most germane to this text is the lack of a common technology plat-• form between disciplines in a learning environment. an integrated curriculum requires an integrated platform to accomplish delivery and evaluation. this is particularly essential to clinical management of the patient by professionals in training as part of a healthcare delivery team. some progress in establishing shared basic sciences curricula has been documented in the literature. to date, no single integrated electronic health (medical-dental) record has been meaningfully adapted for educational purposes, including incorporation of assessment of the learner relative to integrated competencies, integrated case-based and problem-based curriculum, and integrated evaluation and assessment. another concern with new educational programs emerging in response to these reports and relative to creating a transformational integrated curriculum is that some of the programs are focusing primarily on creating clinicians with no value or emphasis on integrating training with research and/or scholarly activity. integrated training models counter such concerns. research will be fundamental to measuring the relative benefi ts and outcomes associated with treatment of patients in a shared curriculum setting and will be the catalyst for the development of integrated medical-dental informatics incorporating educational capabilities. additionally, accreditation will also need to evaluate its response to such models. presently it is unclear how accrediting bodies will view an integrated crossdisciplinary curriculum. further, due to its integrated nature, such a curriculum would lie outside of the expertise of a single traditional accrediting body focused on one particular discipline. it has yet to be determined how accrediting bodies will review and appraise such cross-disciplinary competencies. lastly, it is important to recognize that a successful education model with innovative informatics is only successful if its focus is patient care. graduating learners with competency only in the use of informatics will be limited unless adapted to training and delivery programs that result in patient centric care. research and reports over the past years support the need to reform dental education. first steps have been taken and lead the way for continued innovation around clinic-based education and integrated curriculum. the models identifi ed point to a strong partnership and interrelationship with chcs for creative, cost saving, effective and sustainable delivery methods. moreover, chc's must be more involved in a training curriculum integrated with informatics. chcs, in turn, benefi t from residents and students through service-learning to help meet a societal and workforce need, while the learners benefi t from increased competency. in order to train an evidence-based, patient-centered, medical-dental workforce, it is imperative that medical and dental data and record accessibility be incorporated into these training and care delivery initiatives. in order to keep moving away from the crossroads, such integration must become the pathway on which curriculum is developed and implemented. public law - 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nsia sha: doc_id: cord_uid: d e zd nan mandela's triumphant release from prison years ago, those halcyon weeks in when we were hosts to the soccer world cup, or more recently siya kolisi's diverse team of players overcoming enormous odds to achieve a global rugby victory -the unity and transcendence of the rainbow nation largely have eluded us. while a pandemic is not the occasion to point fingers, it does expose the structural fault lines that undermine social cohesion. in "normal" times, these fissures are mostly tucked away safely in the recesses of our national collective consciousness. it is as if the virus, anthropomorphised, has pulled back the veil, baring the naked truth of our imperfect realities. there is no place to hide; and, to be totally honest, we are afraid. in south africa, with over total covid- cases and deaths at the time of writing, it is important to reflect on the intersections between the biomedicine of the novel coronavirus and its sociopolitical manifestations. while sars-cov- is clearly a biological phenomenon that clinicians and researchers are learning more and more about each day, we also observe that the disease plays out differently in different bodies and in different social-political realities. no two people, and no two countries, are living and dying from covid- in exactly the same way. while there are common threads of pathophysiology and constraints of health-care systems, the illness experiences of individuals, families, communities and countries are unique, based on underlying contextual factors that are embedded in culture, economics, politics and philosophy. as clinicians, what can we learn from such observations? how can south africa benefit from analysing what has happened in countries that are ahead of us in viral spread? is it possible to avert a future imperfect in our context that is already fraught with social upheavals and inequity? what will a post-covid- health-care workforce look like? these questions, and others, probably keep many of us up at night with good reason. as we struggle to plan for meaningful interventions, what social considerations need to be kept in mind? in the past month, vast amounts have been written capturing the south african experience of the sars-cov- adenovirus that causes covid- disease. from the social distancing necessary to reduce the speed of transmission and flatten the curve, to buying essential goods for the duration of a communal lockdown, to the suffering endured by not consuming alcohol and tobacco, to reports about the personal and collective economic costs, to the nightly release of case statistics by geographical region, to the biographies of those who have died, we have amassed a hefty repository of pandemic stories that are intended to reveal a shared humanity and promote common cause. yet, there is something that should niggle at us, a discomfort as we begin to realise that apart from the similarities, there are also major divergences in our narratives. while transmission is the same for everyone (droplet spread vs aerosolisation which only occurs during invasive medical procedures), we are told that the expression of symptoms can range from completely sub-clinical to severe respiratory failure and death. biomedically, these differences are accounted for by age and/or other comorbidities. in his daily broadcasts, minister of health dr zweli mkhize reassuringly informs the public that those who have died so far would have died anyway from their co-morbid conditions: those with hypertension, diabetes, obesity, chronic obstructive lung disease, end-stage cancer, underlying immunosuppression and the elderly (with the exception of two people under age ).( ) by implying that covid- was simply an added insult to an already-compromised human, he attempts to avoid panic by explaining that these people were already sick. he acknowledges that while the loss to each family is significant, the loss to the collective should be mitigated by this understanding. how true is this, however? it is certainly a more palatable explanation for the mounting death toll: weakened constitutions, people battling to stay alive anyway, a necessary culling of the herd. individual bodies live in communities with histories. these reveal the complex and less visible web of a person's or a community's inherent sociopolitical vulnerabilities that emerge as risk factors for poorer health outcomes. increasingly, it appears that someone's positionality on the uneven playing field of life will determine her prognosis in addition to biological factors for covid- .( , ) although there are well-established links between social positionality and the body's ability to mount an effective immunological response, the exact mechanism of these interactions remains elusive. ( , ) in the united states, we observe relationships between zip code, race and death from covid- , such as in new york city, where latinx people (those with latin american cultural or ethnic identity in the united states) make up % of the population but account for % of the death rate, a difference also seen with black new yorkers ( % of the population and % of the deaths). ( ) there is speculation that poorer access to the advanced technologies for heroic life-saving interventions was the reason; however, there is a growing body of evidence pointing to the intersectional stressors of living with inequality, racism, classism, marginalisation or being "othered" that act at a cellular level even in the presence of adequate medical care. ( ) this interplay between inherited and acquired vulnerability works its way into an embodied expression of disease at a granular level. however, there are ways to conceptualise some of the social and structural forces that increase risk (such as power and privilege) and simultaneously silence the expression and visibility of such suffering.( ) paul farmer points out, "structural violence is one way of describing social arrangements that put individuals and populations in harm's way. […] the arrangements are structural because they are embedded in the political and economic organization of our social world; they are violent because they cause injury to people … neither culture nor pure individual will is at fault; rather, historically given (and often economically driven) processes and forces conspire to constrain individual agency".( ) unlike the direct police violence resulting in the marikana massacre or the brutal rape and murder of uct student uyinene mrwetyana, structural violence is often invisible and has been likened to the unseen mass that lies beneath the tip of every iceberg exerting its influence by creating unequal life chances. structural violence is viewed as simply the way the world works, the natural order of things: entrenched power has become so normalised that it is often difficult to fathom where and how the injury came about. reflecting a recent episode of structural violence in our own health-care context, the life esidimeni tragedy comes to mind. as well intentioned as psychiatric deinstitutionalisation is in theory, economic expediency and a callous disregard for human life trumped professional ethics and the right to dignity. at least people died from hunger, starvation, hypothermia and neglect following the ill-conceived transfer of long-term mental health patients to community-based non-governmental organisations that were not equipped to care for them. what is striking about this disaster, however, is the role of those in the gauteng department of health who foresaw nothing unusual, or turned a blind eye to possible pitfalls, while executing the deinstitutionalisation plan. when reading out the findings from evidence presented to the arbitration commission he chaired, retired deputy chief justice dikgang moseneke commented about the sheer lack of official accountability for the life esidimeni tragedy: "senior provincial heath officials had lied‚ played the victim‚ abused their power and knowingly violated the rights of mentally ill patients and their families because the instruction had come from above". ( ) given that those who were directly responsible for the plan have not yet faced criminal prosecution, it remains whether this incident will be seen as a catastrophe of inordinate proportions or as a massive injustice perpetrated by particular individuals who benefitted. the late political theorist and legal philosopher judith shklar in her book the faces of injustice posits how accountability is apportioned according to how an incident is framed. if one interprets what has occurred as a "misfortune" or rather as an "injustice", there is an important distinction between whether and how accountability can be attributed. although people suffer either way, the depersonification of responsibility for that suffering in the case of a misfortune -a tsunami, landslide, tornado or other natural disaster -assumes that it is the invisible hand of fate at fault. according to shklar, however, a calamity is rarely neutral: scratch deeply enough and there will be an injustice where someone or something has behaved with culpability.( ) returning to our current crisis of covid- , we actually have a choice in how our own responses will be judged by history. like famine, pandemics can either be mitigated or exacerbated by the political leadership and the decisions they make. ( ) in fact, as many have argued, the root causes of mass starvation are wholly human-made. ( ) although extreme weather events such as drought or flooding or a scourge of locusts or other blight may destroy food crops, theorists of the politics of famine argue that it is human beings who first determine their degree of responsiveness to climate change that actually results in such "natural" disasters and after, the nature and extent of food distribution that has been banked for emergencies, often privileging one group over another as food becomes weaponised. the national department of health in its covid- infection prevention and control guidelines for south africa states an obvious truth about combatting the spread of the virus in our particular situation: "south africa has a unique challenge of a large vulnerable immunocompromised population living in overcrowded conditions".( ) over the past years, prior to being hit by the sars-cov- virus, this is a frank admission that we have been sluggish in our duty to address the needs of the masses. despite constitutionally enshrined guarantees to housing, sanitation, nutrition, education, recreation, gender equity and protection of those most vulnerable, progress on these fronts has been achingly slow. while pandemics are the ultimate litmus test of a nation's health system, the social determinants of health have never been more meaningful in our context. the minister of health, dr zweli mkhize, made it clear, "at this point … this is collaborative work. we did say [that] to defeat covid- , it's no longer an issue of a nurse and a doctor. it's actually about society…about going into a combat zone to fight this infection". ( ) attention to the social determinants of health, those underlying predictors of life and death, should give us pause to realise that no amount of ventilators and hospital beds can in fact stem the ravages of a virus that only knows a single pathway, that of vulnerability. we have ignored engaging with them at our peril. stats sa data from / indicate that almost half of the adult population (men and women over age ) were living below the upper bound poverty line, the cut-off point at which there is just enough money for basic nutrition and other essential non-food items such as soap, clothing and sanitary pads. ( ) in , that amount was r per person per month, with women experiencing % higher rates of poverty ( %) than men. ( ) as regards changes in housing value over a year period, the statistics are also grim: "more than half of south african households headed by black africans lived in dwellings that were valued at less than r […] [in contrast], most households headed by indians/asians and whites lived in properties valued at r or more". ( ) in terms of both the number of rooms in these dwellings -and by implication size -"there has been a shift between and towards more rooms in formal dwellings and changes from multiple rooms in informal housing to one to two rooms" (italics added for emphasis). ( ) in another report released by stats sa in february explaining income inequality, there is the stark finding that the poorest % of south african households are now relying more on social grants than paid employment to attain overall household income. this intervention prevents an even greater "income inequality gap between the bottom and top deciles". ( ) despite this attempt at economic stabilisation, the divide between rich and poor is so wide that south africa carries the dubious honour of being the longest running most unequal country on the planet from . ( ) now it seems we must pay the price as the virus threatens to run its course along the fault lines of poverty and inequity. therefore, adherence to world health organisation directives like social distancing is impossible for large swaths of south africans who, through no fault of their own, lack the necessary infrastructure for such adherence. in an ironic twist, a resident of a rural community in mpumalanga expressed his "thanks" to the coronavirus for water. commenting on the installation of "six boreholes [with running taps] and six , litre water tanks" in the space of a week after years of waiting for access to fresh water, another resident pointed out that, "[al]though they (government) had promised us water a long time ago, […] now that we have this virus, we see fast delivery". ( ) ongoing service delivery protests bear testament that in other parts of the country, after decades of neglect, improving access to water and sanitation has not been as successful. similarly, sheltering in place takes on new meaning across the inequality divide. given the challenge highlighted by stat sa ( ) in that % of the country's population live in informal dwellings, corresponding to million people, ( ) physical distancing in such conditions becomes next to impossible. there are substantive differences in self-isolating with a fridge and freezer full of food, opportunities for recreation on one's own lawn or swimming pool or tennis court versus the informality and overcrowding that are daily realities for much of the population. in the early days of the lockdown, we recall the images of law enforcement officials acting with zealousness to confine people to their shacks. as the bbc reported, "the police and army have, at times, acted with thuggish abandon in their attempts to enforce the […] lockdown, humiliating, beating, and even shooting civilians on the streets of the commercial capital, johannesburg, and elsewhere". ( ) similar reports from front-line colleagues providing primary medical care in the townships expressed exasperation that the mall in ebony park remained open, or that it was "business as usual" with informal traders and food vendors in daveyton.( ) despite application of the siracusa principles (see table ) during the declaration of a national disaster to ensure that any limitations of human rights are the least restrictive possible and affect all members of the population without discrimination, is it really possible to apply these principles equally if we live in such an inequitable society? these principles are not explicitly discriminatory against the poor. yet, the lockdown disproportionately affects low-wage workers in precarious employment. during and after the -week lockdown, the consequences of staying home are substantively different on the one hand, for a person with no guarantee of sustainable income or paid sick leave and on the other, for a person with job security or a stable business. can we blame the population for wanting to leave their overcrowded homes and travel to the local clinics during the lockdown to consult on previously neglected health matters? can we blame a parent who, because of lockdown, is not working at her usual three jobs and sees it as an opportunity to catch up on delayed immunisations for children, to extract a tooth that has been bothersome for months or to pass by for a social visit with the staff or other patients? the experiences of confinement and boredom are psychological for those of us with adequate housing. in the townships and informal settlements, these experiences are spatial and material. davis and others have described such toxic urban environments as "… a dumping ground for a surplus population working in unskilled, unprotected and low-wage informal service industries and trade". ( ) in such contexts, does the restriction of rights to freedom of movement and employment carry the same meaning or intention? the current national debates about whether to extend the lockdown, and for how long, reveal the tensions between competing agendas. although few people are explicit about the trade-offs in terms of lives worth sacrificing as opposed to lives worth preserving, experts speak as if we inherently share the same belief that some lives are more precious, or at least worth saving, than others. further signalling the contingencies that will sway the balance between human life, and the survival of the economy is the personification of corporations and businesses: how long can the engines of industry remain moribund without suffering terminal complications? the flip side of this, however, is that there have been some very brave public health-motivated decisions taken by president cyril ramaphosa and his cabinet to regulate industry and repurpose manufacturing to address the pandemic. although the "combat zone" war metaphor may be problematic, it invokes powers for the executive to act in ways that place health at the centre of a societal agenda, something that we have not seen during peacetime. it opens up certain possibilities that are at odds with "getting back to normal", such as the mining industry is keen to do. ( ) embedded in this calculus is what number of human beings can be forfeited to get the stock exchange up and running again -so that the poor can get back to work and not starve; because without employment and in the absence of a meaningful social safety net they will die anyway. we are told that actuarial scientists are key to resolving these equations, presumably relying on a common understanding of what utilitarianism means in our context. while it is acknowledged that we will all take a hit, certain among us must pay with our lives as well as our purse. so, what will be our levels of complicity with managing these "surplus people", those who in the best of times die from falling into a pit latrine, or a delayed cancer diagnosis, or at the hands of a violent partner or from a gang rape for being queer? in conversations with gauteng colleagues regarding their role in the covid- pandemic, they recall the trauma of working or training in apartheid-era segregated hospitals or wards with woefully inadequate resources and security police monitoring, or the overwhelming helplessness in the pre-antiretroviral days when aids patients lay dying on stretchers everywhere. other colleagues are more in tune with the fluidity of this crisis: "well, we are rationing all the time", which is probably a more honest appraisal of the resource constraints (structural violence) we have come to accept as a normal condition of practising in south africa's public health sector in the st century. whether we support national health insurance as the realisation of universal health coverage or not, we are now confronted with a number of questions that will determine our post-pandemic future. what is our appetite as clinicians to tackle these underlying sociopolitical issues, recognising their inexorable links to the current best medical and scientific management of covid- ? it is not a one or another choice. traditionally, clinicians have been averse to engaging in such issues because they are not regarded as purely "medical", but rather political, something that i have written extensively about in the past. yet, these are exceptional and truly ominous times. a set of agreed-upon foundational principles when human rights are temporarily restricted and subject to ongoing review and appeal in so far as • the restriction is provided for and carried out in accordance with the law; • the restriction is in the interest of a legitimate objective of general interest; • the restriction is strictly necessary in a democratic society to achieve the objective; • there are no less intrusive and restrictive means available to reach the same objective; • the restriction is based on scientific evidence and not drafted or imposed arbitrarily i.e. in an unreasonable or otherwise discriminatory manner. ( ) in thinking about what instructs and informs physician advocacy, we can turn to various guidelines. first, the world medical association statement on patient advocacy and confidentiality advises, "medical practitioners have an ethical duty and a professional responsibility to act in the best interests of their patients. this duty includes advocating for patients, both as a group (such as advocating on public health issues) and as individuals".( ) (italics added for emphasis) the canmeds health advocate role, adopted by the health professions council of south africa, states, "as health advocates, physicians contribute their expertise and influence as they work with communities or patient populations to improve health. they work with those they serve to determine and understand needs, speak on behalf of others when required, and support the mobilization of resources to effect change". ( ) (italics added for emphasis) inherent in these professional statements is a divide between the doctor and the patient or community, which recognises both the power differential and a need for therapeutic distancing that is purported to allow objectivity and reason to prevail. this divide also confers an element of safety, a recognition that doctor and patient are not in the same boat, at least not in that exact moment. covid- has changed that equation. now, it is not safe to be caring for patients with sars-cov- , especially in an environment where access to appropriate personal protective equipment may be restricted. st augustine's hospital in durban is closed indefinitely due to an outbreak of covid- at the facility, where nurses and patients who tested positive are being kept in quarantine. ( ) the media coverage of both famous and ordinary doctors from around the world who have died in the line of duty caring for covid- patients makes us question our own mortality and realise that, in this instance, nothing separates us from our patients really, except if fortunate, a medical or n mask. even the retreat to the sanctuary of our own homes is fraught with the risk of unwittingly bringing the virus, trojan horse-like, into our most sacred of spaces. patients are us. we are them. yet, not really. the repercussions of the pandemic will exact a high toll on our collective psyche and on the public's trust in medicine, nursing and the health-care system. clinicians can choose to exhibit leadership in opening up difficult conversations that frame a set of questions about the value of life in principle and about the underlying and obvious value chains of who deserves human rights. we can advise on how to "get people to stay home" by giving them the resources to make that possible. or, we can usher in a police state that will further violently punish poor people for existing while we do nothing to help stop the spread of the virus. community engagement, public education, housing and financial support are required to help people practise physical distancing. our treatment armamentarium for covid- needs to expand if we have a hope of coming through this alive. coronavirus deaths in south africa rise to being a person of color isn't a risk factor for coronavirus. living in a racist country is -the boston globe vulnerable groups. world health organization world health organization perceived discrimination, race and health in south africa racism and health: evidence and needed research new york city's latinx residents hit hardest by coronavirus deaths on suffering and structural violence: a view from below pathologies of power: structural violence and the assault on human rights full: life esidimeni arbitration handed down by moseneke the faces of injustice from cholera to corona: the politics of plagues in africa africa is a country the political economy of famine. a preliminary report of the literature, bibliographic resources, research activities and needs in the uk. institute for research in the social sciences covid- infection prevention and control guidelines for south africa -draft v . department of health covid- recovery patients quadruple: report. sabc news -breaking news, special reports, world, business, sport coverage of all south african current events africa's news leader statistics sa. men, women and children: findings of the living conditions survey national poverty lines. pretoria, gp: isibalo house ghs series volume vii: housing from a human settlement perspective in-depth analysis of general household survey ( - ) and census ( - ) media statement inequality trends in south africa: a multidimensional diagnostic of inequality world bank we thank virus for water', say grateful mpumalanga community we thank virus for water', say grateful mpumalanga community. sowetanlive [internet]. sowetanlive; south africa's ruthlessly efficient fight against coronavirus personal oral communications with clinical colleagues siracusa principles on the limitation and derogation world health organization. who guidance on human rights and involuntary detention for xdr-tb control world health organization planet of slums amcu rules out mines returning to limited operations business day world medical association-wma statement on patient advocacy and confidentiality [internet]. the world medical association royal college of physicians and surgeons of canada. canmeds role: health advocate the royal college of physicians and surgeons of canada durban hospital closed indefinitely due to covid- outbreak i am thankful to antje schuhmann, sanele sibanda, zimitri erasmus and sarala naicker for rich conversations that have assisted in converting my thoughts and ideas around the covid- pandemic into something coherent. i am grateful to my daughter shanthi samara ragaven for a careful read of the text as well as her assistance with putting the references into vancouver citation style. finally, many clinician colleagues from south africa and internationally have generously shared their own frontline experiences which have broadened my own understanding of the challenges we are facing. key: cord- - v r do authors: stevens, jennifer p.; o’donoghue, ashley; horng, steven; tandon, manu; tabb, kevin title: healthcare’s earthquake: lessons from complex adaptive systems to develop covid- -responsive measures and models date: - - journal: nejm catal innov care deliv doi: . /cat. . sha: doc_id: cord_uid: v r do new metrics and forecasting models are key to understanding and anticipating the challenges of the covid- pandemic. complex adaptive systems are distinct from complicated systems. a complicated system is like an engine, with multiple, elaborate components that, when taken apart, are reduced to small, indivisible parts. complicated systems are deterministic; they can be anticipated and predicted. many health care processes that are easily measured and improved, such as placing a central venous line, are complicated. these types of systems are straightforwardly monitored with data systems; tracking incremental changes over time allows us to distinguish between meaningful variation and random noise. complex systems, while they appear to have multiple patterns, are more akin to fractals or biologic processes, in that the closer you look, the more you see. complex systems have numerous emerging and evolving connections with individual agents and are largelynondeterministic--that is, there can be many possible outcomes for a given set of circumstances. for example, an emergency room on a friday night is filled with connections, visible and invisible hierarchies, and structures, with an unpredictable outcome for the evening. as described by sargut and mcgrath, one of the biggest challenges health care leaders face in dealing with complex systems is the "vantage point" problem, where the individual actors and leaders are unable to truly see the whole, especially in rare events like covid- . covid- is health care's "big one" of an earthquake, a rare event turning our complex system of health care on its head." covid- is health care's "big one" of an earthquake, a rare event turning our complex system of health care on its head. many of the variables driving the epidemiology of the disease are only now emerging, several months into the pandemic. carefully constructed dashboards created by institutions for patient flow and safety metrics have been largely up-ended as patients are cared for in different clinical environments. new icus were created overnight in operating rooms, postanesthesia care units, and medical-surgical floors. existing process measures that served as reliable surrogates for outcome measures are no longer reliable as clinical workflows are re-engineered. new financial incentives, such as the payment parity of telehealth, , have created new processes of care overnight. new drug and device shortages created care plans that evolved by necessity. where do all these factors leave health care leaders in their efforts to manage health care operations? we review three strategies for leadership during the current rare event: expanding the vantage point; creating interest and acceptability for evolving metrics; and building forecasting strategies that reflect the complex environment. expand the vantage point: engage diverse thinkers in your dashboard design standard health care leadership groups may include members of the finance team, members of the information systems group, and leadership from medical and nursing staff. many hospitals adapted incident command structures, largely derived from emergency management designs, to create ad hoc leadership and reporting structures during covid- surges. - while these systems primarily create a shared mental model for action, resource demands, and communications, they also bring to the fore additional voices and vantage points for managing health care delivery beyond the bounds of the immediate surge, including which metrics to follow and how to evaluate data. for example, hospital epidemiologists guided our leadership team in designing a dashboard to monitor for a second surge of covid- cases. our nursing leaders asked whether our health care staff of color were disproportionately sick from covid- . as health care leaders, it is time to consider how we can continue to broaden our vantage point. for instance, consider the value of a patient representative to herald shifts in the community's pandemic response; or of a physician who cares for patients most likely to be affected by delayed care during surges, such as oncology; or of members of the clinical and operations staff from communities of color served by the health care network. these voices can supplement the usual voices in incident command structures and leadership structures to help health care leaders see more of the complex system and help them anticipate. metrics and variables in health care data structures allow us to see shifts and changes while we can still intervene. but if we are entirely dependent on specific metrics, we may find ourselves furiously watching one series of metrics while the system itself crumbles around us. instead, we propose creating openness to new metrics, by being watchful for undervalued variables, variables with shifting value, and variables with new values. some examples: undervalued variable: patient demographics. patient demographics were a largely unreported variable in many health care dashboards, even as different public health agencies reported them. what did we miss because of this in our boston-based health system? at beth israel deaconess medical center, one of the two large academic health centers in our network, we had two separate surges that drove our patient population, identified in figure . the first surge was composed disproportionately of patients of color from densely populated areas who were admitted early in the surge (blue line). the second, more protracted surge was composed of a greater proportion of white patients (red line). the two separate surges meant our health care system faced more of a plateau " rather than a peak, as shown in the total population of patients with covid- (green line). the protracted peak had implications for our clinical staff, our personal protective equipment needs, and the continued delay in much of our health care network's operations. shifting value: percentage of covid- patients in the icu. other metrics may change their meaning and usefulness mid-pandemic, even if we do not actively change their definition. one such example is the percentage of covid- patients in our icus. initially, this metric was critical during the surge of covid- cases in our community, with many of our covid- -positive patients admitted with severe acute respiratory distress syndrome, pneumonia, and influenza-like illnesses. these patients needed immediate critical care services, making covid- -positive patients synonymous with symptomatic patients. further, this meant that health care resources that our health care system needed, such as icu beds and ventilators, were also synonymous with covid- -positive patients. in june, many of our hospitals began performing urgent and elective procedures again. as part of providing elective care and creating a safe environment for all patients and staff, we started covid- testing for all patients on admission. this increase in testing created a new denominator problem -suddenly, we had a large number of asymptomatic patients admitted with covid- , rather thanbecause of covid- , who no longer required the same icu resources and other levels of care. the result was our covid- patients suddenly look dramatically less sick with a much smaller percentage in the icu (figure ). without understanding the shifting value of this metric, we might mistake our plummeting covid- -positive icu census for new knowledge about how to clinically manage patients with the disease, or presume the disease had mutated to a less sick form. instead, in a time of low community prevalence, we find a persistent number of covid- positive patients but with less of an impact on critical care resources, which itself has raised the value of a new metric, the number of symptomatic patients with covid- . new value: respiratory illness and influenza-like illness in the ed. influenza-like illness, the most common presentation of active and symptomatic covid- infection, was an early harbinger of the epidemic to come in boston. both throughout february and again following an international conference hosted by the biogen in the final week of february now recognized to be a superspreader event, we noted a higher percentage of influenza-like illness presentations to our ed at the bidmc than in past years during the same time, an early signal of what was to engulf our state in six weeks' time ( figure ) . as we embark on the - influenza season while the covid- pandemic continues, we may face a catastrophic combination of diseases that cause respiratory failure. we propose anticipating these surges with the inclusion of a metric in covid- dashboards that is already collected and reported as part of influenza monitoring: influenza-like illness presentations. whether these be covid- infections or flu, we expect that incorporating other signals may serve to provide additional early warning signals about shifts in resource needs to keep patients safe. finally, as health care systems face increasing shifts in the pandemic, we propose identifying forecasting tools that provide opportunities to learn about the complex system of our health care environment and covid- itself, rather than depending on unrealistic assumptions. many models that were used to forecast covid- , particularly early in the epidemic, fell short of this requirement. some models relied on a susceptible-infected-recovered models, which depend on several assumptions, such as all members of the population are equally likely to get infected ("susceptible"), or all patients who survive can never be re-infected ("recovered"). others, like the institute for health metrics and evaluation (ihme) initially fit their curves to prior data from italy and china to predict results in other, very different communities and countries. unfortunately, oversimplified models are more likely to create chaos than to provide direction for health systems. consider the political consequences on election day of oversimplified election predictions; what would happen if we confidently predicted the results of the election only using voters' income and ignored all recent events? many covid- national models do exactly this -make out-of-date or oversimplified assumptions -which lead to meaningless output and the potential to create major clinical consequences for patients and health systems. for example, models that fail to accommodate the shifting populations of different communities may overstate how many people are at risk of infection, causing a hospital system to direct resources to the wrong clinics and communities. models that do not accommodate shifting public health guidance, school policies, and changing business requirements may understate the numbers, rendering health systems unprepared for second waves of infection. models need to reflect the shifting health and policy landscape -to allow for the complexity of the pandemic itself -for any health care organization to meaningful make use of them. models need to reflect the shifting health and policy landscape -to allow for the complexity of the pandemic itself -for any health care organization to meaningful make use of them." our institution has proposed one modeling solution to this. the solution incorporates hospital decision making, what is known about the virus, and how the massachusetts population is moving around and interacting with one another -in short, a model that reflects the complexity of covid- . we recognize that adding a range of different real-world variables risks creating a model overfitted to our data, which is to say a model that can only describe what has happened in the past but can tell us nothing about what lies ahead or generalize to any other setting. to guard against overfitting while reflecting a complex reality, we did the following. first, we built a multi-hospital (multi-task) model using hospital census data from each of our hospitals within " hospital network, rather than depending on any single institution or the combined network census. second, we asked the model to estimate some of the unknown features of the virus rather than making assumptions about these values in our model, as the scientific landscape of sars-cov- has shifted and the infection itself is new to all of us. for example, rather than use information about the virus such as the number of days patients are infectious, hospitalization rate, etc. from published literature from earlier hit areas such as china or italy, we learned these variables directly from our observed data using machine learning methods. and third, we incorporated information about how people were moving around and how much they were interacting with other people, using publicly available cellphone data, thereby incorporating the shifting policy interventions in our state and shifting norms of behavior. this hybrid approach allows us to learn from data we are observing, but also generate a model that allows us to forecast what might happen if certain variables changed. the result is a forecasting model that leverages the principles of complexity to guide hospital leadership, providing weekly updates to a group of health care leaders about how and when a new surge of infections may arrive. healthcare is facing one of its greatest challenges, in part because we have wrapped ourselves comfortably in familiar metrics and dashboards that weren't designed to handle the problems of complex system. healthcare couldn't see the "big one" coming, a dramatic reminder of the risks of oversimplifying a complex problem. to move forward, we have to build models that reflect the true complexity we are facing, to engage new voices that let us understand the next challenge we will face, and to remain flexible and curious about our metrics. we are still squarely in the middle of this earthquake and we have many aftershocks ahead. learning to live with complexity understanding health care delivery science implications for telehealth in a postpandemic future: regulatory and privacy issues telehealth and patient satisfaction: a systematic review and narrative analysis covid- best practice information: emergency operations centers. world health organization. a systematic review of public health emergency operations centres (eoc) use of incident command system for disaster preparedness: a model for an emergency department covid- response clinical characteristics of hospitalized covid- patients how a premier u.s. drug company became a virus "super spreader locally informed simulation to predict hospital capacity needs during the covid- pandemic wrong but useful -what covid- epidemiologic models can and cannot tell us how one boston hospital built a covid- forecasting system. hbr.org, key: cord- -cl gydrj authors: rosen, lawrence d.; felice, kate tumelty; walsh, taylor title: whole health learning: the revolutionary child of integrative health and education date: - - journal: explore (ny) doi: . /j.explore. . . sha: doc_id: cord_uid: cl gydrj nan adverse childhood experiences (aces), potentially traumatic events disproportionately affecting our most vulnerable children, greatly increase risk for poor physical and emotional health outcomes in adults. toxic stress, triggered by aces-related trauma, significantly affects nervous, endocrine, and immune system functioning, even altering dna and ultimately brain structure via epigenetic mechanisms. clinical phenomena resulting include distractibility, impulsivity, emotional dysregulation and a multitude of learning difficulties. children thus impacted are at higher risk for physical and emotional health challenges throughout their lifetimes and more likely to engage in health-risk behaviors. ( ) compounding the above challenges, aces via toxic stress pathways also lead to widening health disparities. ( ) aces are common, with nearly / of adults reporting at least one type of ace in childhood and approximately / reporting experiencing at least three types, ( ) and they are costly: the estimated price to families, communities, and society exceeds hundreds of billions of dollars annually. ( ) impact on education the impact of aces in schools has a reciprocal effect compounding the challenges faced by a child who has experienced trauma. exposure to early trauma affects brain development and reaction to stimuli, specifically in the limbic system and cortex. ( ) this presents challenges to learning, most prominently in the child's executive function, language development, communication, and emotional regulation. a reciprocal effect occurs as the child has challenges not only in learning, but also in reactivity to stimuli in the classroom, such as rejection, failure, negative reinforcement, and punishment. a limbic system shaped by trauma makes the brain state one of constant -fight or flight‖, rather than the relaxed alertness necessary for learning. when the learning process is challenging, it is exacerbated by emotional reactivity, a struggle to regulate, and a perception of threat whether one exists or not. thus, the impact on aces in the classroom can make obstacles to educational success seem insurmountable. responsive pedagogy and educator awareness of mental, emotional, and behavioral health have proven effective in mitigating aces in educational settings. the same limbic brain that perceives threat and activates fear also thrives in an environment rich with positive relationships, reinforcement, and support. ( ) although aces can hinder the academic performance and success of a child, their impact can be mitigated and academic growth can be facilitated with a supportive and safe learning environment, strong relationships in the classroom, and a concerted effort to keep the child in school. reducing academic and attendance challenges contributes to greater academic success, attenuates the impact of adverse experiences into adulthood, and improves health outcomes across the lifespan.( ) educational policy has become increasingly reflective of the need to consider the overall wellbeing of the child -physically, socially, and emotionally -with a focus upon systems and programs that support that holistic scope. an emphasis on social emotional learning (sel) in schools has become an educational priority, as a way to reduce barriers to educational success and to build awareness and understanding of the role of emotional and community wellness in longterm learning and health outcomes. sel, as defined by the collaborative for academic, social, and emotional learning (casel), is -the process through which children and adults understand and manage emotions, set and achieve positive goals, feel and show empathy for others, establish and maintain positive relationships, and make responsible decisions.‖( ) the five key components of sel are self-awareness, self-management, social awareness, relationship skills, and responsible decision-making. while educators inherently recognize the value of educating the whole student by attending to their mental, emotional, and behavioral needs, it has only become a curriculum requirement in recent years, and in certain states. additionally, many schools have independently implemented facets of sel-enabling pedagogy in place, drawing from various health promoting domains such as mindfulness programs, nature education, nutrition learning including teaching kitchens, schools gardens, and cognitive-based physical education. while these initiatives have shown promise, they are staggered and siloed, implemented and evaluated inconsistently across schools, districts, and states. the centers for disease control and prevention support school wellness policies in theory but only cite nutrition and physical activity as critical components. ( ) the whole school, whole community, whole child (wscc) model recognizes the need for improved collaboration between health and education systems to best serve students. ( ) while the wscc paradigm broadens the scope of health promotion to include psychosocial concerns and encourages family and community involvement, it leaves out other promising pieces of a comprehensive integrated program, like mindfulness and the other domains cited previously. though aces and sel have risen to the forefront of educational policy awareness, actually building comprehensive programs can be quite challenging, particularly when educators may be fully aware of the need but lack the time and support to implement and study interventions. the complex interplay between health and educational challenges demands creative new collaborations between both spheres. the siloed solutions of yesterday no longer adequately serve, and the choreographed coordination of health promotion components is needed. access to an integrated, comprehensive, and customizable sel-based wellness studies program, designed to mitigate aces and improve long term health via self-care competency, would greatly benefit students, educators, families, and communities. furthermore, it would complement and amplify existing successful school and community initiatives, creating an accessible, proactive, and holistic wellness creation model for children and families. we call this approach -whole health learning‖ (whl). at its core, whl represents the application of core pediatric integrative health principles ( ) to the educational environment, including these four key values: • preventive: focus on health promotion and creation, favoring proactive strategies to reactive solutions. • context-centered: children are nurtured within the context of healthy families, communities, and schools. • relationship-based: only through open communication and building trust are we best able to work together to ensure each child's optimal wellbeing. • participatory: creating health should be a collaborative process, actively encouraging participation and putting children in control of their own health. delivered via an integrated framework of whole health domains, whl best addresses the complex needs of today's students, serving as a bridge to sustainable, life-long emotional and physical wellbeing. when students graduate high school with a competency in wellness studies, they will have established a foundation for life-long behavioral habits that optimize health outcomes. these habits are what we term -lifestyle prescriptions‖ -nutrition, exercise, sleep, mindfulness, nature -the bedrock of integrative health practice. the whl pilot -named the -wellness studies program‖ -engaged middle school students (grades - ) and included mindfulness, nutrition, cognitive fitness, and nature education components. it was informed by nj sel standards,( ) as well as best practices of partner organizations assisting in program delivery. created by and supplemented with feedback from both educators and students, the program was implemented as a series of workshops introducing specific wellness concepts, each building successively upon the other through reinforcement and experiential learning. the pilot program ran until june, and was funded for re-implementation for the - school year. the wellness studies program is among the earliest known efforts to integrate a set of distinct wellness programs into a unified learning experience designed to meet academic and sel goals. program metrics have been collected and are currently in analysis. the goal is to refine the program and expand to a number of other schools in different geographic regions throughout the u.s. over the next several years. perhaps one day, wellness studies programs will be fully embedded within all u.s. schools as part of a national public wellness initiative. there may be no better method to effectively and equitably improve the health of our nation while simultaneously reducing health care costs. over the past twenty years, integrative health experts have recognized the emerging cascade of socially-determined illnesses and their long-term effects, issuing repeated warnings about the need for urgent action to prevent further erosion of the physical and mental health and wellbeing of our nation's children. despite significant investments by healthcare entities and philanthropic organizations, children's health has continued to deteriorate. the circular impact of poor health on education, and of learning challenges on short-and long-term health, is magnified by the increasing toll of aces and resulting toxic stress on our most vulnerable youth. yet there is hope; evidence suggests that proactive, participatory, community-based interventions are effective strategies to mitigate health risks. recently, several national entities have recognized the value of infusing more holistic health learning in schools, perhaps the most accessible and costeffective environments in which to teach lifelong habits leading to positive health behaviors and, ultimately, health outcomes. ( ) the report highlights three key promotion and prevention strategies, one being programs delivered in school settings. notable is a priority -to teach children in preschool and grades k- social and emotional skills, including mindful awareness practices.‖ this expressed support of whole health learning programs within schools as effective means to ameliorate the impact of aces on education and health is welcome. however, educators alone cannot be asked to solve the immense challenges inherent in creating and sustaining an optimally effective and cost-effective health promotion system. the institute of medicine, in a report titled -schools & health: our nation's investment,‖( ) cautioned, -the schools of yesteryear were not expected to solve the health and social problems of the day by themselves; the medical, public health, social work, legislative, and philanthropic sectors all pitched in. given the scope and complexity of the health problems of today's children and young people, it is again likely that schools will not be able to provide solutions without the cooperation and support of families, community institutions, the healthcare enterprise, and the political system.‖ this remains the case, nearly a quarter of a century later. the iom report noted that -a strong interconnected infrastructure will be essential if cshp [coordinated school health programs] are to become established and flourish.‖( ) what was an empirical study of chronic diseases in the united states: a visual analytics approach age, period, and cohort trends in mood disorder indicators and suicide-related outcomes in a nationally representative dataset prevalence and treatment of depression, anxiety, and conduct problems in us children epidemiology and impact of health care provider-diagnosed anxiety and depression among us children environmental injustice: children's health disparities and the role of the environment. explore (ny) the growing pediatric health gap: environmental injustice threatens our future. explore (ny) kids count data book: state trends in child well-being understanding snap, the supplemental nutrition assistance program effects of poverty centers for disease control and prevention. preventing adverse childhood experiences (aces): leveraging the best available evidence committee on psychosocial aspects of child and family health; committee on early childhood, adoption, and dependent care; section on developmental and behavioral pediatrics. the lifelong effects of early childhood adversity and toxic stress prevalence of adverse childhood experiences from the - behavioral risk factor surveillance system in states preventing adverse childhood experiences the body keeps the score: brain, mind, and body in the healing of trauma education and learning in the context of childhood abuse, neglect and related stressor: the nexus of health and education whole community pediatric integrative medicine: vision for the future. children (basel) emotional well-being: emerging insights and questions for future research the goldie hawn foundation fostering healthy mental, emotional, and behavioral development in children and youth: a national agenda evolution of school health programs key: cord- -bbae nam authors: gougelet, robert m. title: disaster mitigation date: - - journal: disaster medicine doi: . /b - - - - . - sha: doc_id: cord_uid: bbae nam nan c h a p t e r the definition of mitigation includes a wide variety of measures taken before an event occurs that will prevent illness, injury, and death and limit the loss of property. mitigation planning commonly includes the following areas: • the ability to maintain function • building design • locating buildings outside of hazard zones (e.g., flood plains) • essential building utilities • protection of building contents • insurance • public education • surveillance • warning • evacuation it is of critical importance that emergency planners incorporate the basic elements of mitigation and have the authority and resources to incorporate these changes into their organization/facility/community. emergency planners should have a basic idea of the concepts of mitigation through their use in natural disasters over the years. the recent federally mandated transition to the all-hazards approach in disaster emergency response has also given a new perspective on mitigation. although it is not necessary to redefine mitigation, it is essential to understand how the scope and complexity of mitigation and risk reduction strategies have evolved as the united states adapts to new threats. for example, what measures can be taken in advance to protect the population and infrastructure from an earthquake, flood, ice storm, or terrorist attack? as with each mass casualty event, the answers to this question are location-specific and heavily dependent on the circumstances surrounding the event. however, a common understanding of the goals and concepts of mitigation along with knowledge of its policy history and current practices will help a community develop mitigation plans that are both locally effective and economically sustainable. this chapter illustrates how mitigation strategies have evolved, outlines key historical elements of u.s. mitigation policy, highlights critical current mitigation practices, and describes common pitfalls that can hamper mitigation efforts. the realm of mitigation planning is far reaching and complex, and, therefore, the emphasis of this chapter is on the continuity of medical care during a mass casualty event within a community. in the simplest of terms, mitigation means to lessen the possibility that a mass casualty event can cause harm to people or property. however, this simple definition covers a broad range of possible activities. for example, an effort to ensure that essential utilities, such as electricity and phone service, continue to be available throughout a natural disaster is very different from efforts to minimize the economic damage of postdisaster recovery from a major flood or attempts to educate the public on how to reduce their risk of exposure during a dirtybomb incident. mitigation strategies can range from focusing exclusively on "hardening" to focusing more on resiliency. hardening of targets is best described as measures that are taken to physically protect a facility, such as bolting down equipment, securing power and communications lines, installing backup generators, placing blast walls, or physically locking down and securing a facility. mitigation through hardening has only limited use in systems or facilities such as hospitals where open access to the surrounding community is the hallmark of their operations. in these circumstances, a resilient system capable of flexing to accommodate damage and the ability to maintain or even expand current operations will make that system ultimately more secure. mitigation through resiliency also has limitations. in many cases, hardening structures is most appropriate, particularly when many citizens may be quickly affected without prior notice or warning. this may include hardening structures in earthquake zones, physically protecting and monitoring the food chain and drinking water systems, and physically securing and protecting nuclear power plants. in these cases, resiliency may come too late to prevent illness and death in large numbers of patients, and planners should target hardening to whatever degree is practically and financially feasible. the threats of nuclear, radiological, chemical, and biological attacks present new challenges for emergency planners. the potentially covert nature of the attack, the wide variety of possible agents (including contagious agents), and soft civilian targets make planning efforts exponentially more difficult than in the past. this complexity has also eroded the distinction between mitigation and response activities. although it is never possible to mitigate or to plan responses for all contingencies, we do know, however, that there is a basic common response framework. this framework includes coordination, communication to enable inter-agency information sharing, and flexibility to rapidly adapt emergency plans to different sitvations. traditionally, mitigation in the united states has focused on natural disasters; however, early mitigation planning against manmade disasters included civilian fallout shelters and the evacuation of target cities if a nuclear attack was eminent. the federal emergency management agency (fema) states : mitigation is the cornerstone of emergency management. it's the ongoing effort to lessen the impact disasters have on people's lives and property through damage prevention and flood insurance. through measures such as; zoning restrictions to prevent building in hazard zones (e.g. flood plains, earthquake fault lines), engineering buildings and infrastructures to withstand earthquakes: and creating and enforcing effective building codes to protect property from floods, hurricanes and other natural hazards, the impact on lives and communities is lessened. mitigation begins with local communities assessing their risks from recurring problems and making a plan for creating solutions to these problems and reducing the vulnerability of their citizens and property to risk. however, since the mid- s, mitigation planning has become increasingly more complex. terrorist attacks, industrial accidents, and new or reemerging infectious diseases are just a few of the threats that have started to consume more planning time and resources. the growing scope of threats that must be addressed in mitigation strategies challenges all aspects of planning and response at all levels of government. [ ] [ ] [ ] the importance of sharing intelligence information at the earliest possible stage of a terrorist attack, especially a bioterrorism event, is now recognized in national policy as a critical mitigation asset. theoretically, if there were the slightest indication of a contagious biological attack occurring within the united states, then early recognition triggered by intelligence alerts followed by appropriate local responses could allow for isolation, treatment, and containment of a potentially widespread event. this intelligence sharing must become a large part of mitigation efforts aimed at limiting the effectiveness of manmade disasters. a similar analogy can be made with the early warning given to the medical community when a surveillance system picks up an unusual cluster of illnesses, long before the initial diagnosis may be made at a physician's office or healthcare facility. the new national incident management system (nims) states that intelligence must be shared within the incident management structure and states that a sixth functional area, or incident command system section, covering intelligence functions may be established during the time of an emergency. the elevated status of intelligence within nims establishes the importance of early and effective intelligence sharing. the challenge is to establish these sharing relationships before the disaster by incorporating them into an ongoing hazard monitoring process and by integrating them into drills, exercises, and day-to-day activities to ensure that this critical resource is operational when needed to mitigate the consequences of a disaster. the disaster mitigation act of (dma- ) elevated the importance of mitigation planning within communities by authorizing the funding of certain mitigation programs and by involving the office of the president. under dma- , the president may authorize funds to communities or states that have identified natural disasters within their borders and have demonstrated public-private natural disaster mitigation partnerships. dma- provides economic incentives through promoting awareness and education to prioritize the following objectives for federal assistance to states, local communities, and indian tribes: • forming effective community-based partnerships for hazard mitigation purposes • implementing effective hazard mitigation measures that reduce the potential damage from natural disasters • ensuring continued functionality of critical services • leveraging additional nonfederal resources in meeting natural disaster resistance goals • making commitments to long-term hazard mitigation efforts to be applied to new and existing structures this important legislation sought to identify and assess the risks to states and local governments (including indian tribes) from natural disasters. the funding would be used to implement adequate measures to reduce losses from natural disasters and to ensure that the critical services and facilities of communities would continue to function after a natural disaster. further evidence of the expanding complexity of mitigation efforts can be found in the terrorism insurance risk act of . this act fills a gap within the insurance industry, which typically does not provide insurance coverage for large-scale terrorist events. the federal government, in the wake of the sept. , , attacks, promptly passed this act, addressing concerns about the potential widespread impact on the economy. the act provides a transparent shared public-private program that compensates insured losses as a result of acts of terrorism. the purpose is to "protect consumers by addressing market disruptions and ensure the continued widespread availability and affordability of property and casualty insurance for terrorism risk; and to allow for a transitional period for the private markets to stabilize, resume pricing of such insurance, and build capacity to absorb any future losses, while preserving state insurance regulation and consumer protections." , effective mitigation planning now is expected to include many different aspects of private industry. private industry is a critical partner; its involvement may range from being a potential risk to the community, such as a chemical plant, to providing assistance in responding to an event. this is especially true in the area of healthcare; most healthcare in the united states is provided by the private sector. it is important to note that the national fire protection association (nfpa) recently released nfpa ,standard on disaster/emergency management and business continuity programs, edition. this standard establishes a common set of criteria for disaster management, emergency management, and business continuity. planners may use these criteria to assess or develop programs or to respond to and recover from a disaster. although mitigation planning has become an essential feature of nearly every industry and institution in the wake of sept. , , healthcare settings are disproportionately affected by new challenges and complexities in mitigation. the severe acute respiratory syndrome (sars) outbreak shook the foundation of mitigation and prevention in healthcare when healthcare workers and first responders in china and canada died in after caring for patients with the sars virus. access to several toronto area hospitals was significantly limited for several months because of illness, quarantined staff, and concerns about contamination. the economic costs to the city of toronto were in the billions of dollars. hospitals and their communities were thrown into a complex mitigation and prevention crisis. the association of state and health officials (astho) has come out with specific guidelines and checklists to help prepare states and communities prepare for a possible outbreak. pan-influenza planning closely parallels sars planning, with considerable effort toward preventive vaccination of the population and emphasis on protecting healthcare workers. effective strategies were learned during the toronto sars outbreak, although it was definitely a "learn-as-you-go-along" situation. the most effective mitigation strategies to prepare for the consequences of an outbreak would be to plan for the home quarantine of patients, establish public information strategies to reduce public concern, to close affected facilities until the knowledge base permitted their safe reopening, plan for a coordinated information and command and control center, and have preestablished protocols and procedures in place to protect the health of healthcare workers and first responders. vaccination is an essential component of hospital and community mitigation planning. during the fall of , the u.s. government requested that all states prepare for a smallpox attack. the preparations called for each state to present a plan within days to vaccinate all persons within the state, starting with healthcare workers. each facility and community needs to look at the risk of a disease, the effect of vaccination on healthcare workers, and the ability to maintain continuity of care. if properly informed, healthcare workers could respond and treat patients without risk to themselves or their families. the availability of a vaccination and the ability to mass vaccinate the majority of the population should be considered in all community response plans. the plans for both sars and paninfluenza now need to address the availability and possible stockpiling of antiviral agents as well as procedures for mass vaccination of the population, if a vaccine were to become available. we have learned much from the many earthquakes, tornadoes, hurricanes, fires, and floods that the united states has experienced, but it is extremely difficult to plan for terrorist and natural events that can quickly overwhelm communities, states, or even the whole nation. these historical events, policy developments, and shifts in public attention have created a very complex planning and operating environment. the next section of this chapter addresses some of the key current practices that mitigation strategists should consider. current mitigation strategies are as varied as the circumstances in which they are formed. this section illustrates the impact of mitigation through a comparison of responses to two earthquakes that were broadly separated in geography and community preparedness. these examples are followed by a discussion of critical elements of mitigation and risk reduction practice in three broad categories: coordination with other organizations and jurisdictions, hospital concerns, and mitigation strategies based in community health promotion and surveillance. the first step for protecting communities and their critical facilities against earthquakes is a comprehensive risk assessment based on current seismic hazard mapping. this determination of location should also include the assessment of underlying soil conditions, the potential for landslide, and other potential hazards. communities located on seismic fault lines must also develop and enforce strict building codes. after the bam, iran, earthquake, a large section of the city, at first glance, looked like a burned forest with only the bare trees left standing. it soon became clear that these were steel vertical beams standing upright in mounds of concrete rubble. in comparison, after the northridge, calif., earthquake many of the buildings were structurally compromised but did not collapse on their occupants. undoubtedly, this was the result of the strict building codes and enforcement throughout the state of california. to the victims of the bam earthquake, the most important lifesaving measures may have been the development and enforcement of strict building codes. building codes are minimum standards that protect people from injury and loss of life from structural collapse. they do not ensure that normal community functioning might continue after a significant event. structural protection of facilities requires the active role of qualified and experienced structural engineers during planning, construction, remodeling, and retrofitting. the immediate response of a structural engineer after a disaster is to assess building damage and to assist in determining the need for evacuation and the measures needed to ensure continuity of function. extensive analysis of seismic data taken during an earthquake that are compared with subsequent building damage has given structural engineers valuable information on structural failures of buildings. this information allows communities to rebuild with better and stronger facilities. the following measures to protect the structural integrity of a facility should be in place before an incident : • a contract with a structural engineering firm to participate in planning, construction, retrofitting, and remodeling • a contractual agreement guaranteeing the response, after an event, of a structural engineer (with appropriate redundancy) to ensure structural stability, to assess the need for evacuation, and to take additional measures to ensure the continuity of essential functions • inventory and classify all buildings • conduct a vulnerability assessment • ensure code compliance • determine public safety risks • determine structural reinforcement needs, and prioritize them • prepare lists of vulnerable structures for use in evacuation and damage assessment extensive resources and technical assistance for structural earthquake protection are available on the internet. fema's web site itemizes these resources into three major categories: earthquake engineering research centers and national earthquake hazards reduction program-funded centers, earthquake engineering and architectural organizations, and codes and standards organizations. fema has released the risk management series publications, which provide very specific guidance to architects and engineers about protecting buildings against terrorist attacks. the institute for business and home safety is also an excellent source of incident-specific information for both businesses and homes. the protection of facilities from earthquake damage also involves protecting the facility's nonstructural elements. these nonstructural elements do not comprise the fundamental structure of the building (box - ). primary damage to nonstructural elements may be the result of overturning, swaying, sliding, falling, deforming, and internal vibration of sensitive instruments. relatively simple measures, which do not require a structural engineer, may be taken to prevent damage to or from nonstructural elements. these measures may include fastening loose items and structures, anchoring top-heavy items, tethering large equipment, or using spring mounts. other elements, such as stabilizing a generator from vibration damage by placing it on spring mounts or from sliding damage by having slack in attached fuel and power lines, may require the assistance of an engineer. hospitals and other medical care facilities are especially vulnerable to damage from nonstructural elements. consider the placement of routine medical care items such as intravenous poles, monitors/defibrillators, and pharmaceutical agents and medical supplies on shelves. loss of emergency power to key services, such as computed tomography scanners, laboratory equipment, and dialysis units, may also significantly affect the continuity of medical care (e. aur der heide, personal communication, february ). loss of generator power may be due to failure of crossover switches, loss of cooling, or loss of connection of power and fuels lines. a process for the continual review of the power needs of new and critical equipment should be a part of a hospital's emergency planning process. cooperating with the federal government and understanding the resources, structure, and timeframe in which the federal resources are available are critical to appropriate mitigation planning. nims and the national response plan are described elsewhere in this book. each document describes in detail the organizational structure and response authority of the federal government in the time of a disaster. , healthcare organizations, communities, and states are mandated to ensure that their strategies for mitigation, response, and recovery are developed in coordination with these national models. presidential decision directive homeland security presidential directive (hspd) # mandates that by fiscal year ,"the secretary shall develop standards and guidelines for determining whether a state or local entity has adopted the nims, " and all mitigation and risk reductions strategies should be designed accordingly. in addition to efforts to coordinate with federal plans, mitigation strategists must also build functional partnerships within communities and across jurisdictional lines. this point has been emphasized in several recently published planning guides. , [ ] [ ] [ ] these guides help hospitals and their communities plan for mass casualty events by incorporating key features of planning, risk assessment, exercises, communications, and command and control issues into functional and operational programs. hospitals also present special challenges. presidential decision directive hspd # specifies that hospitals qualify as first responders. as such, they have important mitigation activities to consider. what does mitigation mean for a hospital? in the current threat environment, it means minimizing the impact of an event on the institution and ensuring continuity of care. accessibility to the public -hours a day, seven days a week has been a hallmark of hospital emergency care. however, one of the most important mitigation strategies a hospital can adopt is the ability to limit and control access to patients and families during the time of a mass casualty or a hazardous materials event. additionally, facilities must have plans and the ability to decontaminate patients, protect essential staff and their families, handle a surge of patients with complimentary plans for the forward movement of patients to surrounding areas, set up alternative treatment facilities within the community, to train staff in early recognition and treatment of illness or injury related to weapons of mass destruction, and ensure continuity of care and financial stability during and after an event. although hospitals will always form the cornerstone for medical treatment of patients during mass casualty events, best practices for hospitals must now also incorporate healthcare resources within the community. hospitals will have to work with other first responders within the community to conduct drills and exercises that realistically test the whole hospital's ability to respond to a mass casualty event. hospitals also will have to ensure that staff members have the proper training to complete hazard vulnerability assessments and to set up and staff outpatient treatment facilities to ensure continuity of care. , even with very careful planning, most communities will be overwhelmed for the first minutes to hours or possibly days after a massive event, until an effective and prolonged response can occur. communities must also look at the continuity of medical care as a communitywide issue and not just emphasize the hospital or emergency medical services aspects of medical care. the loss of community-based clinics, private medical offices, nursing homes, dialysis units, pharmacies, and visiting nurse services can significantly increase the number of patients seeking care at hospitals during a mass casualty event. risk communication and education, specifically aimed at protecting the affected population, can help prevent surges of medical patients. hospitals now have enormous community responsibilities in terms of preparing for and mitigating mass casualty events. hospitals in hurricane, flood, earthquake, and tornado zones have prepared for many years against these threats. however, a pattern of repeated systems failures within hospitals continues and includes communications and power loss, with additional physical damage to the facility. to prevent such failures, hospitals need to recognize that mitigation and risk reduction planning must approach the level of detail and logistical support that parallels military planning. surveillance is another key mitigation strategy for health emergencies. early recognition of sentinel cases in biological events can significantly affect the outcome, particularly in contagious events. states are funded and required to participate in the surveillance programs mandated in cdc and health resources and services administration guidelines. , the earlier an event is recognized, especially if it involves a contagious disease, the earlier treatment can begin and preventive measures can be taken to prevent the spread of illness to healthcare workers and responders, as well as the rest of the community. public health departments are critical to establishing relationships between local providers and their communities. local, state, and federal public health agencies must ensure that effective surveillance at the community level occurs. these agencies can also assist in awareness-level and personal protection training for hospital staff, emergency medical service employees, and law enforcement first responders. motivating healthcare facilities to take part in mitigation is one of the largest challenges in disaster medicine. it is always best to take measures beforehand to minimize property damage and prevent injury and death. in the case of hospitals, some preliminary research indicates that four factors affect an institution's motivation to mitigate: influence of legislation and regulation, economic considerations, the role of "champions" within the institution, and the impact of disasters and imminent threats on agenda-setting and policy making. it was discovered during this research that "mitigation measures were found to be most common when proactive mitigation measures were mandated by regulatory agencies and legislation." tax incentives, government assistance grants, and building code and insurance requirements may also serve to motivate administrators and decision makers to put the necessary time and effort into mitigation planning. extensive mitigation activities are a necessary prerequisite for the response and recovery activities that must follow a large-scale mass casualty event. we have never seen the number of casualties in the united states we are preparing for today. we do have the threat of an enemy who will strike within the united states with the purpose of inflicting mass numbers of casualties on the civilian population. we must maintain the perspective that even the smallest chance of such an incredibly devastating event, whether manmade or natural, warrants our full attention. if there is no other motivating factor, the possibly such an event must suffice. principles of hospital disaster planning smallpox response plan and guidelines (version . ) severe acute respiratory syndrome (sars) biological and chemical terrorism: strategic plan for preparedness and response. recommendations of the cdc strategic planning workgroup federal emergency management agency. the disaster mitigation act of terrorism risk insurance act of insuring against terror? nfpa standard on disaster/ emergency management and business continuity programs association of state and territorial health officials and national association of county and city health officials. state and local health official epidemic sars checklist association of state and territorial health officials. preparedness planning for state health officials sars transmission and hospital containment. emerg infect dis federal management emergency agency. mitigation ideas: possible mitigation measures by hazard type, a mitigation planning tool for communities personal observations during deployment: dmat nm#- northridge earthquake community medical disaster planning and evaluation guide: an interrogatory format. am coll emerg physicians data acquisition for earthquake hazard mitigationabstract. presented at: international workshop on earthquake injury epidemiology for mitigation and response governor's office of emergency services. hospital and earthquake preparedness guidelines federal emergency management agency, national earthquake hazards reduction program. publications and resources federal emergency management agency, mitigation division institute for business and home safety technical guidelines for earthquake protection of nonstructural items in communication facilities. bay area regional earthquake preparedness project (barepp) federal emergency management agency, response and recovery. a guide to the disaster declaration process and federal disaster assistance national incident management system homeland security presidential directive/hspd- : management of domestic incidents it takes a community: the army's integrated bioterrorism response model. frontline first responder medical disaster conference. coordination draft: conference report improving local and state agency response to terrorist incidents involving biological weapons homeland security presidential directive/ hspd- : national preparedness joint commission on accreditation of healthcare organizations. health care at the crossroads: strategies for creating and sustaining community-wide emergency preparedness systems revised environment of care standards for the comprehensive accreditation manual of hospitals analyzing your vulnerability to hazards acute care center: a mass casualty care strategy for biological terrorism incidents neighborhood emergency help center pamphlet: a mass casualty care strategy for biological terrorism incidents. available at hospital responses to acute-onset disasters: a review. prehospital disaster med department of health and human services,health resources and services administration. national bioterrorism hospital preparedness program continuation guidance for cooperative agreement on public health preparedness and response for bioterrorism-budget year five disaster mitigation in hospitals: factors influencing decision-making on hazard loss reduction guidelines for vulnerability reduction in the design of new health care facilities principles of disaster mitigation in health facilities protecting new health care facilities from disasters key: cord- - rgz t authors: radandt, siegfried; rantanen, jorma; renn, ortwin title: governance of occupational safety and health and environmental risks date: journal: risks in modern society doi: . / - - - - _ sha: doc_id: cord_uid: rgz t occupational safety and health (osh) activities were started in the industrialized countries already years ago. separated and specific actions were directed at accident prevention, and the diagnosis, treatment and prevention of occupational diseases. as industrialization has advanced, the complexity of safety and health problems and challenges has substantially grown, calling for more comprehensive approaches. such development has expanded the scope, as well as blurred the borders between specific activities. in the modern world of work, occupational safety and health are part of a complex system that involves innumerable interdependencies and interactions. these are, for instance, safety, health, well-being, aspects of the occupational and general environment, corporate policies and social responsibility, community policies and services, community social environment, workers’ families, their civil life, lifestyles and social networks, cultural and religious environments, and political and media environments. a well-functioning and economically stable company generates resources to the workers and to the community, which consequently is able to maintain a positive cycle in development. a high standard of safety and health brings benefits for everyone: the company, the workers and the whole community. these few above-mentioned interactions elucidate the need for an integrated approach, and the modelling of the complex entity. if we picture osh as a house, this integrated approach could be the roof, but in order to build a stable house, it is also necessary to construct a solid basement as a foundation to the house. these basement "stones" are connected to each other, and are described in more detail in sections . - . . section . focuses on the existing hazards, while section . mainly considers the exposure of workers to health hazards. health, due to its complexity, however, is not only influenced and impaired by work-related hazards, but also by hazards arising from the environment. these two sub-chapters are thus linked to section . . in addition, the safety levels of companies may affect the environment. the strategies and measures needed for effective risk management, as described in section . , therefore also contribute to reducing the risks to the environment. in the case of work that is done outdoors, the hazards arising from the environment understandably have to be given special attention. here, the methods applied to tackle the usual hazards at workplaces are less effective. it is necessary to develop protective measures to avoid or minimize hazards present in the environment. namely, agriculture, forestry and construction involve these types of hazards, and affect high numbers of workers on a global scale. finally, hazards in the environment or in leisure-time activities can lead to strain and injuries which -combined with hazards at work -may result in more severe health consequences. as an example one can mention the hazardous substances in the air causing allergies or other illnesses. another example is the strain on the musculoskeletal system from sports and leisuretime activities causing low back pain and other musculoskeletal disorders. depending on the type of hazard, the three topics, namely, safety, health and the environment, may share the common trait that the proper handling of risks, i.e., how to reduce probabilities and/or consequences of unwanted events is not always possible within a risk management system. this is true when one moves into the realm of uncertainty, i.e., when there is uncertain, insufficient or no knowledge of the consequences and/or probabilities (see chapter ). . integrated multi-sectorial bodies for policy design and planning (national safety and health committee). . comprehensive approach in osh activities. . multi-disciplinary expert resources in inspection and services. . multi-professional participation of employers' and workers' representatives. . joint training in integrated activities. . information support facilitating multi-professional collaboration. international labour office (ilo) ( ) international labour conference, st session, report vi, ilo standards-related activities in the area of occupational safety and health: an in-depth study for discussion with a view to the elaboration of a plan of action for such activities. sixth item on the agenda. international labour office, geneva. what are the main challenges arising from the major societal changes for business/companies and workers/employees? how can these challenges be met in order to succeed in the growing international competition? what is the role of occupational safety and health (osh) in this context? the above-mentioned changes create new possibilities, new tasks and new risks to businesses in particular, and to the workers as well. in order to optimize the relation between the possibilities and the risks (maximize possibilities -minimize risks) there is a growing need for risk management. risk management includes all measures required for the target-oriented structuring of the risk situation and safety situation of a company. it is the systematic application of management strategies for the detection, assessment, evaluation, mastering and monitoring of risks. risk management was first considered exclusively from the point of view of providing insurance coverage for entrepreneurial risks. gradually the demands of jurisdiction grew, and the expectations of users and consumers increased with regard to the quality and safety of products. furthermore, the ever more complex problems of modern technology and ultimately the socioeconomic conditions have led to the development of risk management into an independent interdisciplinary field of work. risks can be regarded as potential failures, which may decrease trust in realizing a company's goals. the aim of risk management is to identify these potential failures qualitatively and quantitatively, and to reduce them to the level of a non-hazardous and acceptable residual risk potential. the development and formulation of a company's risk policy is regarded as the basis of effective risk management. this includes, first and foremost, the management's target concept with respect to the organization of work, distribution of labour, and competence of the departments and persons in charge of risk management. risk issues are important as far as acceptance of technology is concerned. it is not enough to reduce the problem to the question of which risks are tolerable or acceptable. it appears more and more that, although the risks themselves are not accepted, the measures or technologies causing them are. value aspects have an important role in this consideration. a positive or negative view of measures and technologies is thus influenced strongly by value expectations that are new, contradictory and even disputed. comparing risks and benefits has become a current topic of discussion. the relation between risks and benefits remains an unanswered question. the general public has a far broader understanding of the risks and benefits of a given technology than the normal understanding professed by engineering sciences which is limited to probability x harm. the damage or catastrophe potential, qualitative attributes such as voluntary nature and controllability also play an important role in the risk assessment of a technology. a normative setting for a certain, universally accepted risk definition according to engineering science is therefore hardly capable of consensus at the moment. the balanced management of risks and possibilities (benefits) is capable of increasing the value of a company. it may by far surpass the extent of legal obligations: for example, in germany, there is a law on the control and transparency for companies (kontrag) . the respective parameters may be defined accurately as follows: • strategic decisions aim to offer opportunities for acquiring benefit, taking into consideration risks. • risks that can have negative consequences to the technological capacities, the profitability potential, the asset values and the reputation of a company, as well as the confidence of shareholders are identified and measured. • the management focuses on important possibilities and risks, and addresses them adequately or reduces them to a tolerable level. the aim is not to avoid risks altogether, but to create opportunities for promoting proactive treatment of all important risks. the traditional occupational health hazards, such as physical, chemical and biological risks, as well as accidents, will not totally disappear as a consequence of change, nor will heavy physical work. about - % of workers are still exposed to such hazards. there is thus need to still develop risk assessment, prevention and control methods and programmes for these often well-known hazards. in many industrialized countries, prevention and control programmes have had a positive impact by reducing the trends of occupational diseases and accidents, particularly in big industries. some developing countries, however, show an increase in traditional hazards. international comparisons, however, are difficult to make because of poor coverage, underreporting, and poor harmonization of concepts, definitions and registration criteria. statistics on occupational accidents are difficult to compare, and therefore data on their total numbers in europe should be viewed with caution. the majority of countries, however, have shown declining trends in accident rates irrespective of the absolute numbers of accidents. some exceptions to this general trend have nevertheless been seen. the accident risk also seems to shift somewhat as regards location, so that instead of risks related to machines and tools, particularly the risks in internal transportation and traffic within the workplace grow in relative importance. this trend may increase in future, particularly as the work place, as well as the speed and volume of material flows are increasing. a threat is caused by lengthened working hours, which tend to affect the vigilance of workers and increase the risk of errors. small-scale enterprises and micro-enterprises are known to have a lower capacity for occupational health and safety than larger ones. in fact, a higher accident risk has been noted in medium-sized companies, and a lower risk in very small and very large enterprises. we can conclude that this is due to the higher mechanization level and energy use in small and medium-sized enterprises (sme) compared with micro-enterprises, which usually produce services. on the other hand, the better capacity of very large enterprises in safety management is demonstrated by their low accident rates. the production of chemicals in the world is growing steadily. the average growth has been between - % a year during the past - decades. the total value of european chemical production in was about usd billion, i.e. % of the world's total chemical production, and it has increased % in the -year period of - . the european union (eu) is the largest chemical producer in the world, the usa the second, and japan the third. there are some , different chemical entities in industrial use, but only about , are so-called high-production volume (hpv) chemicals produced (and consumed) in amounts exceeding , tons a year. the number of chemicals produced in amounts of - , tons a year is about , . but volume is not necessarily the most important aspect in chemical safety at work. reactivity, toxicological properties, and how the chemicals are used, are more important. the european chemical companies number some , , and in addition there are , plants producing plastics and rubber. surprisingly, as many as % of these are smes employing fewer than workers, and % are micro-enterprises employing fewer than workers. thus, the common belief that the chemical industry constitutes only large firms is not true. small enterprises and self-employed people have much less competence to deal with chemical risk assessment and management than the large companies. guidance and support in chemical safety is therefore crucial for them. the number of workers dealing with chemicals in the european work life is difficult to estimate. the chemical industry alone employs some . million workers in europe, i.e. about % of the workforce of manufacturing industries. about %, i.e. over , work in chemical smes. but a much higher number of workers are exposed in other sectors of the economy. there is a distinct trend showing that the use of chemicals is spreading to all sectors, and thus exposures are found in all types of activities: agriculture, forestry, manufacturing, services and even in high-tech production. the national and european surveys on chemical exposures in the work environment give very similar results. while about % of the eu work-ers were exposed to hazardous chemicals, the corresponding figure in central and eastern european countries may be much higher. the workers are exposed simultaneously to traditional industrial chemicals, such as heavy metals, solvents and pyrolytic products, and to "new exposures", such as plastics monomers and oligomers, highly reactive additives, cross-linkers and hardeners, as well as to, for example, fungal spores or volatile compounds in contaminated buildings. this implies that some million people in the eu are exposed at work, and usually the level of exposure is one to three orders of magnitude higher than in any other environment. about the same proportion ( % of the workforce, i.e. , ) of the finnish workers in the national survey reported exposure. the chemicals to which the largest numbers of workers are exposed occur typically in smes; they are e.g. detergents and other cleaning chemicals, carbon monoxide, solvents, environmental tobacco smoke, and vegetable dusts. european directives on occupational health and safety require a high level of protection in terms of chemical safety in all workplaces and for all workers. risk assessment and risk management are key elements in achieving these requirements. the risk assessment of chemicals takes place at two levels: a) systems-level risk assessment, providing a dose-response relationship for a particular chemical, and serving as a basis for standard setting. risk assessment at the systems level is carried out in the pre-marketing stage through testing. this consequently leads to actions stipulated in the regulations concerning standards and exposure limits, labelling and marking of hazardous chemicals, limitations in marketing, trade and use. in this respect, the level of safety aimed at remains to be decided. is it the reasonably achievable level or, for example, the level achieved by the best available technology? the impact is expected to be system-wide, covering all enterprises and all workers in the country. this type of risk assessment is an interactive practice between the scientific community and the politically controlled decision making. a high level of competence in toxicology, occupational hygiene and epidemiology is needed in the scientific community. and the decision makers must have the ability to put the risk in concern into perspective. in most countries the social partners also take part in the political decision making regarding occupational risks. b) workplace risk assessment directed at identifying the hazards at an individual workplace and utilizing standards as a guide for making decisions on risk management. risk assessment at workplace level leads to practical actions in the company and usually ensures compliance with regulations and standards. risk assessment is done by looking at the local exposure levels and comparing these with standards produced in the type a) risk assessment. risk management is done through preventive and control actions by selecting the safest chemicals, by controlling emissions at their source, by general and local ventilation, and by introducing safe working practices. if none of the above is effective, personal protective devices must be taken into use. noise is a nearly universal problem. the products of technology, which have freed us from the day-to-day survival struggle, have been accompanied by noise as the price of progress. however, noise can no longer be regarded as an inevitable by-product of today's society. not only is noise an undesirable contaminant of our living environment, but high levels of noise are frequently present in a variety of work situations. many problems arise from noise: annoyance, interference with conversation, leisure or sleep, effects on work efficiency, and potentially harmful effects, particularly on hearing. in short, noise may affect health, productivity, and well-being. the selection of appropriate noise criteria for the industry depends on knowledge of the effects of noise on people, as well as on the activities in which they are engaged. many of the effects are dependent on the level, and the magnitude of the effects varies with this level. hearing damage is not the only criterion for assessing excessive noise. it is also important to consider the ability and ease of people to communicate with each other. criteria have therefore been developed to relate the existing noise environment to the ability of the typical individual to communicate in areas that are likely to be noisy. the effects of noise on job performance are difficult to evaluate. in general, one can say that sudden, intermittent, high-intensity noise impedes efficient work more than low-intensity and steady-state noise. the complexity of the task with which noise interferes plays a major role in determining how much noise actually degrades performance. two common ways in which noise can interfere with sleep are: delaying the onset of sleep, and shifting sleep stages. one effect of noise that does not seem to depend strongly on its level is annoyance. under some circumstances, a dripping water faucet can be as annoying as a jackhammer. there are no generally accepted criteria for noise levels associated with annoyance. if the noise consists of pure tones, or if it is impulsive in nature, serious complaints may arise. new information and communication technologies (ict) are being rapidly implemented in modern work life. about % of workers have computers at work, and about % are e-mail and internet users. there are three main problem areas in the use of new ict at work. these are: ) the visual sensory system, ) the cognitive processes, and ) the psychomotoric responses needed for employing hand-arm systems. all three have been found to present special occupational health and even safety problems, which are not yet fully solved. the design of new more user-friendly technology is highly desirable, and the criteria for such technology need to be generated by experts in neurophysiology, cognitive psychology and ergonomics. it is important to note that the productivity and quality of information-intensive work requiring the use of ict depends crucially on the user-friendliness of the new technology interface, both the hardware and software. communication and information technologies will change job contents, organization of work, working methods and competence demands substantially in all sectors of the economy in all countries. a number of new occupational health and safety hazards have already arisen or are foreseen, including problems with the ergonomics of video display units, and musculoskeletal disorders in shoulder-neck and arm-hand systems, information overload, psychological stress, and pressure to learn new skills. the challenge to occupational health and safety people is to provide health-based criteria for new technologies and new types of work organization. it is also important to contribute to the establishment of healthy and safe work environments for people. in the approved and draft standards of the international standardization organization, iso, there are altogether about different targets dealing with the standardization of eyesight-related aspects. vision is the most important channel of information in information-intensive work. from the point of view of seeing and eye fatigue, the commonly used visual display units (vdu) are not the most optimal solutions. stability of the image, poor lighting conditions, reflections and glare, as well as invisible flicker, are frequent problems affecting vision. the displays have, however, developed enormously in the s, and there is evidence that the so-called flat displays have gradually gained ground. information-intensive work may increasingly load the vision and sense of hearing, particularly of older workers. even relatively minor limitations in vision or hearing associated with ageing have a negative effect on receiving and comprehending messages. this affects the working capacity in information-intensive work. the growing haste in information-intensive work causes concern among workers and occupational health professionals. particularly older workers experience stress, learning difficulties and threat of exclusion. corrective measures are needed to adjust the technology to the worker. the most important extension of the man-technology interface has taken place in the interaction of two information-processing elements: the central nervous system and the microprocessor. the contact is transmitted visually and by the hands, but also by the software which has been developed during the s even more than the technology itself. many problems are still associated with the immaturity of the software, even though its user-friendliness has recently greatly improved. the logic and structure of the software and the user systems, visual ergonomics, information ergonomics, the speed needed, and the forgiving characteristics of programs, as well as the possibility to correct the commands at any stage of processing are the most important features of such improvements. also the user's skills and knowledge of information technology and the software have a direct effect on how the work is managed and how it causes workload. the user-friendliness and ergonomics of the technology, the disturbing factors in the environment, haste and time pressure, the work climate, and the age and professional skills of the individual user, even his or her physical fitness, all have an impact on the cognitive capacity of a person. this capacity can to a certain extent be improved by training, exercise and regulating the working conditions, as well as with expert support provided for the users when difficulties do occur. the use of new technologies has been found to be associated with high information overload and psychological stress. the problem is not only typical for older workers or those with less training, but also for the super-experts in ict who have shown an elevated risk of psychological exhaustion. there are four main types of ergonomic work loads: heavy dynamic work that may overload both the musculoskeletal and cardiovascular system; re-petitive tasks which may cause strain injuries; static work that may result in muscular pain; and lifting and moving heavy loads, which may result in overexertion, low back injury, or accidental injuries. visual ergonomics is gaining in importance in modern work life. the overload of the visual sensory system and unsatisfactory working conditions may strain the eye musculature, but can also cause muscle tension in the upper part of the body. this effect is aggravated if the worker is subjected to psychological stress or time pressure. in addition to being a biological threat, the risk of infections causes psychological stress to workers. the improved communication between health services and international organizations provides help in the early detection and control of previously unknown hazards. nevertheless, for example, the danger related to drug abusers continues to grow and present a serious risk to workers in, for example, health services and the police force. some new viral or re-emerging bacterial infections also affect health care staff in their work. the increase in the cases of drug-resistant tuberculosis is an example of such a hazard. the goal of preventive approaches is to exert control on the cause of unwelcome events, the course of such negative events or their outcome. in this context, one has to decide whether the harmful process is acute (an accident) or dependent on impact duration and stimulus (short-, medium-, and long-term). naturally, the prevention approaches depend on the phases of the harmful process, i.e. whether the harm is reversible, or whether it is possible only to maintain its status, or to slow down the process. it is assumed here that a stressful factor generates an inter-individual or intra-individual strain. thus the effects and consequences of stress are dependent on the situation, individual characteristics, capabilities, skills and the regulation of actions, and other factors. the overall consideration is related to work systems characterized by work contents, working conditions, activities, and actions. system performance is expected of this work system, and this system performance is characterized by a performance structure and its conditions and requirements (figure . ). the performance of the biopsychosocial unit, i.e. the human being, plays an important role within the human performance structure (see figures . and . ). the human being is characterized by external and internal features, which are closely related to stress compatibility, and thus to strain. in this respect, preventive measures serve to optimize and ensure performance, on the one hand, and to control stress and strain, on the other. preventive measures aim to prevent bionegative effects and to facilitate and promote biopositive responses. • the internal factors affecting performance are described by performance capacity and performance readiness. • performance capacity is determined by the individual's physiological and psychological capacity. • performance readiness is characterized by physiological fitness and psychological willingness. • the external factors affecting performance are described by organizational preconditions/requirements and technical preconditions/requirements. • regarding the organizational requirements, the organizational structure and organizational dynamics are of significance. • in the case of technical requirements, the difficulties of the task, characterized by machines, the entire plant and its constructions, task content, task design, technical and situation-related factors, such as work layout, anthropometrics, and quality of the environment, are decisive (table . ). mental stress plays an increasing role in the routine activities of enterprises. through interactive models of mental stress and strain, it is possible to represent the development of mental strain and its impairing effects (e.g. tension, fatigue, monotony, lack of mental satisfaction). it is important to distinguish the above-mentioned impairing effects from each other, since they can arise from different origins and can be prevented or eliminated by different means. activities that strain optimally enhance health and promote safe execution of work tasks. stress essentially results from the design parameters of the work system or workplace. these design parameters are characterized by, e.g.: • technology, such as work processes, work equipment, work materials, work objects; • anthropometric design; • work techniques, working hours, sharing of work, cycle dependence, job rotation; • physiological design that causes strain, fatigue; • psychological design that either motivates or frustrates; • information technology, e.g. information processing, cognitive ergonomic design; • sociological conditions; and • environmental conditions, e.g. noise, dust, heat, cold. the stress structure is very complex, and we therefore need to look at the individual parameters carefully, taking into account the interactions and links between the parameters at the conceptual level. the design parameters impact people as stress factors. as a result, they also turn into conditions affecting performance. such conditions can basically be classified into two types: a person's internal conditions, characterized in particular by predisposition and personality traits, and a person's external conditions, determined mainly by the design parameters. when we look at performance as resulting from regulated or reactive action, we find three essential approaches for prevention: • the first approach identifies strain. it is related to anatomical, biochemical, histological, physiological characteristic values, typical curves of organ systems, the degree of utilization of skills through stress, and thus the degree of utilization of the dynamics of physiological variables in the course of stress. • the second approach is related to the control of strain. the aim is to identify performance limits, the limits of training and practice, and to put them into positive use. adaptation and fatigue are the central elements here. • the third approach for prevention is related to reducing strain. the aim is to avoid harm, using known limits as guidelines (e.g. maximum workplace concentration limit values for harmful substances, maximum organspecific concentration values, biological tolerance values for substances, limit values for noise and physical loads). however, the use of guideline values can only be an auxiliary approach, because the stress-strain concept is characterized by highly complex connections between the exogenous stress and the resulting strain. an objectively identical stress will not always cause the same level of strain in an individual. due to action regulation and individual characteristic values and curves of the organ systems (properties and capabilities), differences in strain may occur. seemingly identical stress can cause differing strain due to the superposition of partial stress. combinations of partial stress can lead to compensatory differences (e.g. physiological stress can compensate for psychological stress) or accumulation effects. partial stress is determined by the intensity and duration of the stress, and can therefore appear in differing dimensions and have varying effects. in assessing overall stress, the composition of the partial stress according to type, intensity, course and time is decisive. partial stress can occur simultaneously and successively. in our considerations, the principle of homeostasis plays an important role. however, optimizing performance is only a means to an end in a prevention programme. the actual purpose is to avoid harm, and thus to control strain. harm is a bionegative effect of stress. the causative stress is part of complex conditions in a causal connection. causal relationships can act as dose-effect relationships or without any relation to the dose. in this respect, the causative stress condition can form a chain with a fixed or variable sequence; it can add up, multiply, intensify or have an effect in only specific combinations, and generate different effects (e.g. diseases). we are thus dealing with a multicausal model or a multi-factor genesis. low back pain is an example of a complex phenomenon. the incidence of musculoskeletal disorders, especially low back pain, is rapidly increasing. several occupational factors have been found to increase the risk for low back pain. some studies indicate that psychosocial and work-related conditions are far more accurate in the prognosis of disability than are physical conditions. chronic low back pain is perceived as a phenomenon which encompasses biological, social and psychological variables. according to the model of adaptation, the goal of reducing risks is to increase a person's physical abilities (i.e. flexibility, strength, endurance), the use of body mechanics, techniques to protect the back (following the rules of biomechanics), to improve positive coping skills and emotional control. the following unfavourable factors leading to back pain have been identified at workplaces: • the lifting of too heavy loads. • working in a twisted or bent-down position. • work causing whole-body vibration. • working predominantly in a sitting position. • carrying heavy loads on the shoulders. the prevention of acute back pain and the prevention of work disability must entail several features. one important element is work safety, which can be maximized by screening a worker's physical and intellectual capacities, by ensuring ergonomic performance of the work procedures, and by increasing awareness of proper working techniques that do not strain the back. the use of adaptation programmes makes it possible to attain a higher performance level and to be able to withstand more strain (figure . ) . research-based methods of training optimize and improve performance. they are a means for controlling stress and strain with the aim of preventing bionegative effects and facilitating and promoting biopositive responses. the stress (load) and strain model and human performance can be described as follows: • causative stress generates an inter-individual or intra-individual strain. • the effects and consequences depend on a person's properties, capabilities, skills and the regulation of actions, individual characteristics of the organ systems, and similar factors. • within the performance structure, the performance of the biopsychosocial unit, i.e. the human being, plays an important role. the human being is characterized by external and internal factors, which in turn are closely related to stress compatibility and thus to strain. the connection between stress and harm plays a significant role in the research on occupational health hazards. how should this connection be explored? different hypotheses exist in replying to this question, but none of them have been definitively proven. the three most common hypotheses today are: stress occurring in connection with a person's life events. the number and extent of such events is decisive. problem-coping behaviour and/or social conditions are variables explaining the connection between stress and harm. . the additive stress hypothesis. the ability to cope with problems and the social conditions has an effect on harm which is independent of the stress resulting from life events. when we refer to the complexity of risks in this context of occupational safety our focus shall be on the enterprise. there are different kinds of risks to be found in enterprises. many of them are of general importance, i.e. they are in principle rather independent of an enterprise's size or its type of activity. how to deal with such risks shall be outlined to some extent here. in order to treat those risks at work successfully resources are needed whose availability often depends on the enterprise's situation. the situation in enterprises usually is a determining indicator for available resources to control and develop safety and health and thus performance of the enterprise and its workers and employees through appropriate preventive measures. this situation has been described to some extent in chapter . big companies usually have well-developed safety and health resources, and they often transfer appropriate policies and practices to the less developed areas where they operate. even in big enterprises, however, there is fragmentation of local workplaces into ever smaller units. many of the formerly in-built activities of enterprises are outsourced. new types of work organizations are introduced, such as flat and lean organizations, increase of telework and call centres, many kinds of mobile jobs and network organizations. former in-company occupational health services are frequently transferred to service providers. this leads to the establishment of high numbers of micro-enterprises, small scale enterprises (sses), small and medium-sized enterprises (smes) and self-employed people. sses and smes are thus becoming the most important employers in the future. from a number of studies there is evidence that at least among a part of sses and smes awareness of osh risks is low. both managers and workers often do not see the need to improve occupational safety and health or ergonomic issues and their possibilities and benefits by reducing or eliminating risks at work. as these types of enterprises, even more the self-employed, do not have sufficient resources or expertise for implementing preventive measures, the need for external advisory support, services and incentives is evident and growing. interpersonal relations in sses and smes being generally very good provides a strong chance for effectively supporting them. other special features in the structure of small and medium-sized enterprises to be considered are: • direct participation of the management in the daily activities; • the management structure is designed to meet the requirements of the manager; • less formal and standardized work processes, organizational structures and decision processes; • no clear-cut division of work: -wide range of tasks; and -less specialization of the employees; • unsystematic ways of obtaining and processing information; • great importance of direct personal communication; • less interest in external cooperation and advice; • small range of internal, especially long-term and strategic planning; and • stronger inclination of individual staff members to represent their own interests. the role of occupational health services (ohs) in smes is an interdisciplinary task, consisting of: • risk assessment: -investigation of occupational health problems according to type of technology, organization, work environment, working conditions, social relationships. • surveillance of employees' health: -medical examinations to assess employees' state of health; and -offering advice, information, training. • advice, information, training: -measures to optimize safety and health protection; and -safe behaviour, safe working procedures, first aid preparedness. different kinds of risks are found in enterprises (see table . ). these different types of risks need to be handled by an interlinked system to control the risks and to find compromises between the solutions. figure . illustrates these linkages. the promotion of safety and health is linked to several areas and activities. all of these areas influence the risk management process. the results of risk treatment not only solve occupational health and safety problems, but they also give added value to the linked fields. specific risk management methods are needed to reach the set goal. one needs to know what a risk is. the definition of risk is essential: a risk is a combination of a probability -not frequency -of occurrence, and the associated unwelcome outcome or impact of a risk element (consequence). risk management is recognized as an integral part of good management practice. it is a recurring process consisting of steps which, when carried out in a sequence, allow decision making to be improved continuously. risk management is a logical and systematic method of identifying, analyzing, evaluating, treating, monitoring and communicating risks arising during any activity, function, or process in a manner enabling the organization to minimize losses and maximize productive opportunities. different methods are available for analyzing problems. each method is especially suited to respond to certain questions and less suited for others. a complex "thinking scheme" is necessary for arranging the different analyses correctly within the system review. such a scheme includes the following steps: . defining the unit under review: the actual tasks and boundaries of the system (a fictitious or a real system) must be specified: time, space and state. . problem analysis: all problems existing in the defined system, including problems which do not originate from the system itself, are detected and described. . causes of problems: all possible or probable causes of the problems are identified and listed. . identifying interaction: the dependencies of the effect mechanisms are described, and the links between the causes are determined. . establishing priorities and formulating targets: to carry out this step, it is necessary to evaluate the effects of the causes. . solutions to the problems: all measures needed for solving the individual problems are listed. the known lists usually include technical as well as non-technical measures. since several measures are often appropriate for solving one problem, a pre-selection of measures has to be done already at this stage. however, this can only be an approach to the solution; the actual selection of measures has to be completed in steps and . . clarifying inconsistencies and setting priorities: as the measures required for solving individual problems may be inconsistent in part, or may even have to be excluded as a whole, any inconsist-encies need to be clarified. a decision should then be made in favour or against a measure, or a compromise may be sought. . determining measures for the unit under review: the measures applicable to the defined overall system are now selected from the measures for the individual problems. . list of questions regarding solutions selected for the overall system: checking whether the selected measures are implementable and applicable for solving the problems of the overall system. . controlling for possible new problems: this step consists of checking whether new problems are created by the selected solution. the close link between cause and effect demands that the processes and sub-processes must be evaluated uniformly, and risks must be dealt with according to a coordinated procedure. the analysis is started by orientation to the problem. this is done in the following steps: . recognizing and analyzing the problem according to its causes and extent, by means of a diagnosis and prediction, and comparison with the goals aimed at. . description and division of the overall problem into individual problem areas, and specifying their dependencies. . defining the problem and structuring it according to the objectives, time relation, degree of difficulty, and relevance to the goal. . detailed analysis of the causes, and classification in accordance to the possible solution. the analysis of the problem should be integrated into the overall analytical process in accordance with the thinking schemes described earlier. the relevance and priorities related to the process determine the starting point for the remaining steps of the analysis. analyses are divided into quantitative and qualitative ones. quantitative analyses include risk analyses, that is, theoretical safety-related analysis methods and safety analyses, e.g. classical accident analyses. qualitative analyses include failure mode and effect analyses, hazard analyses, failure hazard analyses, operating hazard analyses, human error code and effect analyses, information error and effect analyses. the theoretical safety-related analysis methods include inductive and deductive analyses based on boolean models. inductive analyses are, e.g. fault process analyses. deductive analyses are fault tree analyses, analytical processes and simulation methods. theoretical safety-related analysis methods which are not based on boolean models are stochastic processes, such as markow's model, risk analyses and accident analyses which, as a rule, are statistical or probability-related analyses. a possible scheme to begin with is shown in figure . . since absolute safety, entailing freedom from all risks, does not exist in any sphere of life, the task of those dealing with safety issues is to avert hazards and to achieve a sustainable reduction of the residual risk, so that it does not exceed a tolerable limit. the extent of this rationally acceptable risk is also influenced by the level of risk which society intuitively considers as being acceptable. those who propose definitions of safety are neither authorized nor capable of evaluating the general benefit of technical products, processes and services. risk assessment is therefore focused at the potential harm caused by the use or non-use of the technology. the guidelines given in "a new approach to technical harmonization and standards" by the council resolution of may are valid in the european union. the legal system of a state describes the protective goals, such as protection of life, health, etc., in its constitution, as well as in individual laws and regulations. as a rule, these do not provide an exact limit as to what is still a tolerable risk. this limit can only be established indirectly and unclearly on the basis of the goals and conceptions set down by the authorities and laws of a state. in the european union, the limits are expressed primarily in the "basic safety and health requirements". these requirements are then put into more concrete terms in the safety-related definitions issued by the bodies responsible for preparing industrial standards. compliance with the standards is voluntary, but it is presumed that the basic requirements of the directives are met. the term which is opposite to "safety" is "hazard". both safe and hazardous situations are founded on the intended use of the technical products, processes and services. unintended use is taken into account only to the extent that it can be reasonably foreseen. the risks present in certain events are, in a more narrow sense, unwelcome and unwanted outcomes with negative effects (which exceed the range of acceptance). unwelcome events are • source conditions of processes and states; • processes and states themselves; and • effects of processes and states which can result in harm to persons or property. an unwelcome event can be defined as a single event or an event within a sequence of events. possible unwelcome events are identified for a unit under review. the causes may be inherent in the unit itself, or outside of it. in order to determine the risks involved in unwelcome events, it is necessary to identify probabilities and consequences. the question arises: are the extent and probability of the risk known? information is needed to answer this question. defining risk requires information concerning the probability of occurrence and the extent of the harm of the consequences. uncertainty is given if the effects are known but the probability is unknown. ignorance is given if both the effects and the probability are unknown. figure . shows the risk analysis procedure according to the type of information available. since risk analyses are not possible without practical, usable information, it is necessary to consider the nature of the information. the information is characterized by its content, truth and objectivity, degree of confirmation, the possibility of being tested, and the age of the information. the factors determining the content of the information are generality, precision and conditionality. the higher the conditionality, the smaller is the generality, and thus the smaller the information content of the statement. truth is understood as conformity of the statement with the real state of affairs. the closer that the information is to reality, the higher is its information content, and the smaller its logical margin. the degree of controllability is directly dependent on the information content: the bigger the logical margin, the smaller the information content, and thus the higher the probability that the information content will prove its worth. in this respect, probability plays a role in the information content: the greatest significance is attributed to the logical hypothetical probability and statistical probability of an event. objectivity and age are additional criteria for any information. the age and time relation of information play a particularly important role, because consideration of the time period is an important feature of analysis. as a rule, information and thus the data input in the risk analysis consist of figures and facts based on experience, materials, technical design, the organization and the environment. in this regard, most figures are based on statistics on incidents and their occurrences. factual information reveals something about the actual state of affairs. it consists of statements related to past conditions, incidents, etc. forecast-type predictions are related to real future conditions, foretelling that certain events will occur in the future. explanatory information replies to questions about the causes of phenomena, and provides explanations and reasons. it establishes links between different states based on presumed cause-effect relationships. subjunctive information expresses possibilities, implying that certain situations might occur at present or in the future, thus giving information about conceivable conditions, events and relationships. normative information expresses goals, standards, evaluations and similar matters; it formulates what is desirable or necessary. the main problem with risk analyses is incomplete information, in particular regarding the area of "uncertainty". in the eu commission's view, recourse to the so-called precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified via objective scientific evaluation, and that scientific evaluation does not allow the risk to be determined with sufficient certainty. recourse to the precautionary principle thus takes place in the framework of general risk management that is concretely connected to the decision-making process. if application of the precautionary principle results in the decision that action is the appropriate response to a risk, and that further scientific information is not needed, it is still necessary to decide how to proceed. apart from adopting legal provisions which are subject to judicial control, a whole range of actions is available to the decision-makers (e.g. funding research, or deciding to inform the public about the possible adverse effects of a product or procedure). however, the measures may not be selected arbitrarily. in conclusion, the assessment of various risks and risk types which may be related to different types of hazards requires a variety of specific risk assessment methods. if one has dependable information about the probability and consequences of a serious risk or risky event, one should use the risk assessment procedure shown in figure . . • major industrial accidents; • damage caused by dangerous substances; • nuclear accidents; • major accidents at sea; • disasters due to forces of nature; and • acts of terrorism. • dangerous substances discharged (fire, explosion); • injury to people and damage to property; • immediate damage to the environment; • permanent or long-term damage to terrestrial habitats, to fresh water, to marine habitats, to aquifers or underground water supplies; and • cross-border damage. • technical failure: devices, mountings, containers, flanges, mechanical damage, corrosion of pipes, etc.; • human failure: operating error, organizational failure, during repair work; • chemical reaction; • physical reaction; and • environmental cause. system analysis is the basis of all hazard analyses, and thus needs to be done with special care. system analysis includes the examination of the system functions, particularly the performance goals and admissible deviations in the ambient conditions not influenced by the system, the auxiliary sources of the system (e.g. energy supply), the components of the system, and the organization and behaviour of the system. geographical arrangements, block diagrams, material flow charts, information flow charts, energy flow charts, etc. are used to depict technical systems. the objective is to ensure the safe behaviour of the technical systems by design methods, at least during the required service life and during intended use. qualitative analyses are particularly important in practice. as a rule, they are form sheet analyses and include failure mode and effect analyses, which examine and determine failure modes and their effects on systems. the preliminary hazard analysis looks for the hazard potentials of a system. the failure hazard analysis examines the causes of failures and their effects. the operating hazard analysis determines the hazards which may occur during operation, maintenance, repair, etc. the human error mode and effect analysis examines error modes and their effects which occur because of wrong behaviour of humans. the information error mode and effect analysis examines operating, maintenance and repair errors, fault elimination errors and the effects caused by errors in instructions and faulty information. theoretical analysis methods include the fault tree analysis, which is a deductive analysis. an unwelcome incident is provided to the system under review. then all logical links and/or failure combinations of components or partial system failures which might lead to this unwelcome incident are assembled, forming the fault tree. the fault tree analysis is suited for simple as well as for complex systems. the objective is to identify failures which might lead to an unwelcome incident. the prerequisite is exact knowledge about the functioning of the system under review. the process, the functioning of the components and partial systems therefore need to be present. it is possible to focus on the flow of force, of energy, of materials and of signals. the fault process analysis has a structure similar to that of the fault tree analysis. in this case, however, we are looking for all unwelcome incidents as well as their combinations which have the same fault trigger. analysis of the functioning of the system under review is also necessary for this. analyses can also be used to identify possible, probable and actual risk components. the phases of the analysis are the phases of design, including the preparation of a concept, project and construction, and the phases of use which are production, operation and maintenance. in order to identify the fault potential as completely as possible, different types of analyses are usually combined. documentation of the sufficient safety of a system can be achieved at a reasonable cost only for a small system. in the case of complex systems, it is therefore recommended to document individual unwelcome incidents. if solutions are sought and found for individual unwelcome incidents, care should be taken to ensure that no target conflicts arise with regard to other detail solutions. with the help of the fault tree, it is possible to analyse the causes of an unwelcome incident and the probability of its occurrence. decisions on whether and which redundancies are necessary can in most cases be reached by simple estimates. four results can be expected by using a fault tree: . the failure combination of inputs leading to the unwelcome event; . the probability of their occurrence; . the probability of occurrence of the unwelcome event; and . the critical path that this incident took from the failure combination through the fault tree. a systematic evaluation of the fault tree model can be done by an analytical evaluation (calculation) or by simulation of the model (monte-carlo method). a graphic analysis of the failure process is especially suited to prove the safety risk of previously defined failure combinations in the system. the failure mode and effect analysis and the preliminary hazard analysis as mentioned previously, no method can disclose all potential faults in a system with any degree of certainty. however, if one starts with the preliminary hazard analysis, then at least the essential components with hazard potential will be defined. the essential components are always similar, namely, kinetic energy, potential energy, source of thermal energy, radioactive material, biological material, chemically reactive substance. with the fault tree method, any possible failure combinations (causes), leading to an unwelcome outcome, can then be identified additionally. re- are especially suited for identifying failures in a system which pose a risk. liability parameters can be determined in the process, e.g. the frequency of occurrence of failure combinations, the frequency of occurrence of unwelcome events, non-availability of the system upon requests, etc. the failure effect analysis is a supplementary method. it is able to depict the effects of mistakes made by the operating personnel, e.g. when a task is not performed, or is performed according to inappropriate instructions, or performed too early, too late, unintentionally or with errors. it can pinpoint also effects resulting from operating conditions and errors in the functional process or its elements. an important aspect of all hazard analyses is that they are only valid for the respective case under review. every change in a parameter basically requires new analyses. this applies to changes in the personnel structure and the qualification of persons, as well as to technical specifications. for this reason, it is necessary to document the parameters on which each analysis is based. the results of the hazard analyses form the basis for the selection of protective measures and measures to combat the hazards. if the system is modified, the hazards inherent in the system may change, and the measures to combat the hazards may have to be changed as well. this may also mean that the protective measures or equipment which existed at time x for the system or partial system in certain operating conditions (e.g. normal operation, set-up operation, and maintenance phase) may no longer be compatible. different protective measures, equipment or strategies may then be needed. however, hazard analyses do not merely serve to detect and solve potential failures. they form the basis for the selection of protective measures and protective equipment, and they can also test the success of the safety strategies specified. a selection of methods used for hazard analysis is given in annex to section . . risk assessment is a series of logical steps enabling the systematic examination of the hazards associated with machinery. risk assessment is followed, whenever necessary, by actions to reduce the existing risks and by implementing safety measures. when this process is repeated, it eliminates hazards as far as possible. risk assessment includes: • risk analysis: -determining the limits of machinery; -identifying hazards; and -estimating risks. • risk evaluation. risk analysis provides the information required for evaluating risks, and this in turn allows judgements to be made on the safety of e.g. the machinery or plant under review. risk assessment relies on decisions based on judgement. these decisions are to be supported by qualitative methods, complemented, as far as possible, by quantitative methods. quantitative methods are particularly appropriate when the foreseeable harm is very severe or extensive. quantitative methods are useful for assessing alternative safety measures and for determining which measure gives best protection. the application of quantitative methods is restricted to the amount of useful data which is available, and in many cases only qualitative risk assessment will be possible. risk assessment should be conducted so that it is possible to document the used procedure and the results that have been achieved. risk assessment shall take into account: • the life cycle of machinery or the life span of the plant. • the limitations of the machinery or plant, including the intended use (correct use and operation of the machinery or plant, as well as the consequences of reasonably foreseeable misuse or malfunction). • the full range of foreseeable uses of the machinery (e.g. industrial, nonindustrial and domestic) by persons identified by sex, age, dominant hand usage, or limiting physical abilities (e.g. visual or hearing impairment, stature, strength). • the anticipated level of training, experience or ability of the anticipated users, such as: -operators including maintenance personnel or technicians; -trainees and juniors; and -general public. • exposure of other persons to the machine hazards, whenever they can be reasonably foreseen. having identified the various hazards that can originate from the machine (permanent hazards and ones that can appear unexpectedly), the machine designer shall estimate the risk for each hazard, as far as possible, on the basis of quantifiable factors. he must finally decide, based on the risk evaluation, whether risk reduction is required. for this purpose, the designer has to take into account the different operating modes and intervention procedures, as well as human interaction during the entire life cycle of the machine. the following aspects in particular must be considered: • construction; transport; • assembly, installation, commissioning; • adjusting settings, programming or process changeover; • instructions for users; • operating, cleaning, maintenance, servicing; and • checking for faults, de-commissioning, dismantling and safe disposal. malfunctioning of the machine due to, e.g. • variation in a characteristic or dimension of the processed material or workpiece; • failure of a part or function; • external disturbance (e.g. shock, vibration, electromagnetic interference); • design error or deficiency (e.g. software errors); • disturbance in power supply; and • flaw in surrounding conditions (e.g. damaged floor surface). unintentional behaviour of the operator or foreseeable misuse of the machine, e.g.: • loss of control of the machine by the operator (especially in the case of hand-held devices or moving parts); • automatic (reflexive) behaviour of a person in case of a machine malfunction or failure during operation; • the operator's carelessness or lack of concentration; • the operator taking the "line of least resistance" in carrying out a task; • behaviour resulting from pressure to keep the machine running in all circumstances; and • unexpected behaviour of certain persons (e.g. children, disabled persons). when carrying out a risk assessment, the risk of the most severe harm that is likely to occur from each identified hazard must be considered, but the greatest foreseeable severity must also be taken into account, even if the probability of such an occurrence is not high. this objective may be met by eliminating the hazards, or by reducing, separately or simultaneously, each of the two elements which determine the risk, i.e. the severity of the harm from the hazard in question, and the probability of occurrence of that harm. all protective measures intended to reach this goal shall be applied according to the following steps: this stage is the only one at which hazards can be eliminated, thus avoiding the need for additional protective measures, such as safeguarding machines or implementing complementary protective measures. . information about the residual risk. information for use on the residual risk is not to be a substitute for inherently safe design, or for safeguarding or complementary protective measures. risk estimation and evaluation must be carried out after each of the above three steps of risk reduction. adequate protective measures associated with each of the operating modes and intervention procedures prevent operators from being prone to use hazardous intervention techniques in case of technical difficulties. the aim is to achieve the lowest possible level of risk. the design process is an iterative cycle, and several successive applications may be necessary to reduce the risk, making the best use of available technology. four aspects should be considered, preferably in the following order: . the safety of the machine during all the phases of its life cycle; . the ability of the machine to perform its function; . the usability of the machine; and . the costs of manufacturing, operating and dismantling the machine. the following principles apply to technical design: service life, safe machine life, fail-safe and tamper-proof design. a design which ensures the safety of service life has to be chosen when neither the technical system nor any of its safety-relevant partial functions can be allowed to fail during the service life envisaged. this means that the components of the partial functions need to be exchanged at previously defined time intervals (preventive maintenance). in the case of a fail-safe design, the technical system or its partial functions allow for faults, but none of these faults, alone or in combination, may lead to a hazardous state. it is necessary to specify just which faults in one or several partial systems can be allowed to occur simultaneously without the overall system being transferred into a hazardous state (maximum admissible number of simultaneous faults). a failure or a reduction in the performance of the technical system is accepted in this case. tamper-proof means that it is impossible to intentionally induce a hazardous state of the system. this is often required of technical systems with a high hazard potential. strategies involving secrecy play a special role in this regard. in the safety principles described here, redundant design should also be mentioned. the probability of occurrence and the consequences of damage are reduced by multiple arrangements, allowing both for subsystems or elements to be arranged in a row or in parallel. it is possible to reduce the fault potential of a technical system by the diversification of principles: several different principles are used in redundant arrangements. the spatial distribution of the function carriers allows the possibilities to influence faults to be reduced to one function. in the redundant arrangements, important functions, e.g. information transmission, are therefore designed in a redundant manner at different locations. the measures to eliminate or avoid hazards have to meet the following basic requirements: their effect must be reliable and compulsory, and they cannot be circumvented. reliable effect means that the effect principle and construction design of the planned measure guarantee an unambiguous effect, that the components have been designed according to regulations, that production and assembly are performed in a controlled manner, and that the measure has been tested. compulsory effect includes the demand for a protective effect which is active at the start of a hazardous state and during it, and which is deactivated only when the hazardous state is no longer present, or stops when the protective effect is not active. technical systems are planned as determined systems. only predictable and intended system behaviour is taken into account when the system is designed. experience has shown, however, that technical systems also display stochastic behaviour. that is, external influences and/or internal modifications not taken into consideration in the design result in unintended changes in the system's behaviour and properties. the period of time until the unintended changes in behaviour and/or in properties occur, cannot be accurately determined; it is a random variable. we have to presume that there will be a fault in every technical system. we simply do not know in advance when it will take place. the same is true for repairs. we know that it is generally possible in systems requiring re-pair to complete a repair operation successfully, but we cannot determine the exact time in advance. using statistical evaluations, we can establish a timedependent probability at which a "fault event" or "completion of a repair operation" occurs. the frequency of these events determines the availability of the system requiring repair. technical systems are intended to perform numerous functions and, at the same time, to be safe. the influence of human action on safety has to be taken into account in safety considerations as well (i.e. human factor). a system is safe when there are no functions or action sequences resulting in hazardous effects for people and/or property. risks of unwelcome events (in the following called "risk of an event") are determined on the basis of the experience (e.g. catalogue of measures) with technical systems. in addition to this, safety analyses are used (e.g. failure mode and effect analysis, hazard analysis, failure hazard analysis, operating hazard analysis, information error analysis), as well as mathematical models (e.g. worst-case analysis, monte-carlo procedure, markow's models). unwelcome events are examined for their effects. this is followed by considerations about which design modifications or additional protective measures might provide sufficient safety against these unwelcome events. the explanations below present the basic procedure for developing safety-relevant arrangements and solutions, i.e. the thinking and decision-making processes, as well as selecting criteria that are significant for the identification of unwelcome events, the risk of an event, the acceptance limits and the adoption of measures. before preparing the final documentation, it is essential to verify that the limit risk has not been exceeded, and that no new unwelcome events have occurred. the sequence scheme describes the procedure for developing safety arrangements and for finding solutions aiming to avoid the occurrence of unwelcome events which exceed the acceptance limits, by selecting suitable measures. in this context, it is assumed that: • an unwelcome event is initially identified as a single event within a comprehensive event sequence (e.g. start-up of a plant), and the risk of an event and limit risk are determined. • the selection of technical and/or non-technical measures is subject to a review of the content and the system, and the decision regarding a solution is then made. • the number of applicable measures is limited, and therefore it may not be possible to immediately find a measure with an acceptable risk for a preliminary determination of the unwelcome event. • implementation of the selected solution can result in the occurrence of a new unwelcome event. • in the above cases, a more concrete, new determination of the unwelcome event and/or the unit under review, or the state of the unit under review, and another attempt at deciding upon measures may lead to the desired result, although this may have to be repeated several times before it is successful. in the case of complex event sequences, several unwelcome events may become apparent which have to be tackled by the respective set of measures. in accordance with the sequence scheme, the unit under review and its state have to be determined first. this determination includes information on, e.g., • product type, dimension, product parts/elements distinguished according to functional or construction aspects, if applicable; • intended use; • work system or field of application; • target group; • supply energy, transformed in the product, transmitted, distributed, output; • other parameters essential to safety assessment according to type and size of the product; • known or assumed effects on the product or its parts (e.g. due to transport, assembly, conditions at the assembly site, operation, maintenance); • weight, centre of gravity; • materials, consumables; • operating states (e.g. start-up, standstill, test run, normal operation); • condition (new, condition after a period in storage/shutdown, after repair, in case of modified operating conditions and/or other significant changes); and • known or suspected effects on humans. the next step is the identification of unwelcome events. they are source conditions of processes and states, or processes and states themselves. they can be the effects of processes and states which can cause harm to people or property. an unwelcome event can be a single event or part of a sequence of events. one should look for unwelcome events in sequences of processes and functions, in work activities and organizational procedures, or in the work environment. care has to be taken that the respective interfaces are included in the considerations. deviations and time-dependent changes in regard to the planned sequences and conditions have to be taken into account as well. the risk of an unwanted event results from the probability statement which takes into account both • the expected frequency of occurrence of the event; and • the anticipated extent of harm of the event. the expected frequency of occurrence of an event leading to harm is determined by, e.g., • the probability of the occurrence itself; • the duration and frequency of exposure of people (or of objects) in the danger zone, e.g. -extremely seldom (e.g. during repair), -seldom (e.g. during installation, maintenance and inspection), -frequently, and -very frequently (e.g. constant intervention during every work cycle); • the influence of users or third parties on the risk of an event. the extent of harm is determined by, e.g., • the type of harm (harm to people and/or property); • the severity of the harm (slight/severe/fatal injury of persons, or corresponding damage to property); and • number of people or objects affected. in principle, the safety requirements depend on the ratio of the risk of an event to the limit risk. criteria for determining the limit risk are, e.g., • personal and social acceptance of hazards; • people possibly affected (e.g. layman, trained person, specialized worker); • participation of those affected in the process; and • possibilities of averting hazards. the safety of various technical equipment with comparable risk can, for instance, be achieved • primarily by technical measures, in some cases; and • mainly by non-technical measures, in other cases. this means that several acceptable solutions with varying proportions of technical and non-technical measures may be found for a specific risk. in this context, the responsibility of those involved should be taken into consideration. technical measures are developed on the basis of e.g. the following principles: • avoiding hazardous interfaces (e.g. risk of crushing, shearing); hazard sources (e.g. radiation sources, flying parts, hazardous states and actions as well as inappropriate processes); • limiting hazardous energy (e.g. by rupture disks, temperature controllers, safety valves, rated break points); • using suitable construction and other materials (e.g. solid, sufficiently resistant against corrosion and ageing, glare-free, break-proof, non-toxic, non-inflammable, non-combustible, non-sliding); • designing equipment in accordance with its function, material, load, and ergonomics principles; • using fail-safe control devices employing technical means; • employing technical means of informing (e.g. danger signal); • protective equipment for separating, attaching, rejecting, catching, etc.; • suction equipment, exhaust hoods, when needed; • protection and emergency rooms; and • couplings or locks. technical measures refer to, e.g., • physical, chemical or biological processes; • energy, material and information flow in connection with the applied processes; • properties of materials and changes in the properties; and • function and design of technical products, parts and connections. the iterative (repeated) risk reduction process can be concluded after achieving adequate risk reduction and, if applicable, a favourable outcome of risk comparison. adequate risk reduction can be considered to have been achieved when one is able to answer each of the following questions positively: • have all operating conditions and all intervention procedures been taken into account? • have hazards been eliminated or their risks been reduced to the lowest practicable level? • is it certain that the measures undertaken do not generate new hazards? • are the users sufficiently informed and warned about the residual risks? • is it certain that the operator's working conditions are not jeopardized by the protective measures taken? • are the protective measures compatible with each other? • has sufficient consideration been given to the consequences that can arise from the use of a machine designed for professional/industrial use when it is used in a non-professional/non-industrial context? • is it certain that the measures undertaken do not excessively reduce the ability of the machine to perform its intended function? there are still many potential risks connected with hazardous substances about which more information is needed. because the knowledge about the relation between their dose and mode of action is not sufficient for controlling such risks, more research is needed. the following list highlights the themes of the numerous questions related to such risks: • potentially harmful organisms; • toxicants, carcinogens; • pesticides, pollutants, poisonous substances; • genetically engineered substances; • relation between chemical and structural properties and toxicity; • chemical structure and chemical properties and the relation to reactivity and reaction possibilities of organic compounds to metabolic reaction and living systems; • modes of action, genotoxicity, carcinogenicity, effects on humans/animals; • potentially harmful organisms in feedstuffs and animal faeces; • viruses and pathogens; • bacteria in feedstuffs and faeces; • parasites in feedstuffs and animal faeces; • pests in stored feedstuffs; • probiotics as feed additives; and • preservatives in feedstuffs. violent actions damaging society, property or people have increased, and they seem to spread both internationally as well as within countries. these new risks are difficult to predict and manage, as the very strategy of the actors is to create unexpected chaotic events. certain possibilities to predict the potential types of hazards do exist, and comprehensive predictive analyses have been done (meyerson, reaser ) . new methodologies are needed to predict the risk of terrorist actions, and also the strategies for risk management need to be developed. due to the numerous background factors, the preparedness of societies against these risks needs to be strengthened. table . lists important societal systems which are vulnerable to acts of terrorism. the situation in the developing countries needs to be tackled with specific methods. one has to answer the following questions: • what specific examples of prevention instruments can be offered? • what are the prerequisites for success? • how can industrialized countries assist the developing countries in carrying out preventive actions? • how should priorities be set according to the available resources? one possibility is to start a first-step programme, the goal of which is higher productivity and better workplaces. it can be carried out by improving • storage and handling of materials: -provide storage racks for tools, materials, etc.; -put stores, racks etc. on wheels, whenever possible; -use carts, conveyers or other aids when moving heavy loads; -use jigs, clamps or other fixtures to hold items in place. • work sites: -keep the working area clear of everything that is not in frequent use. • machine safety: -install proper guards to dangerous tools/machines; -use safety devices; -maintain machines properly. • control of hazardous substances: -substitute hazardous chemicals with less hazardous substances; -make sure that all organic solvents, paints, glues, etc., are kept in covered containers; -install or improve local exhaust ventilation; -provide adequate protective goggles, face shields, earplugs, safety footwear, gloves, etc.; -instruct and train workers; -make sure that workers wash their hands before eating and drinking, and change their clothes before going home. • lighting: -make sure that lighting is adequate. • social and sanitary facilities: -provide a supply of cool, safe drinking water; -have the sanitary facilities cleaned regularly; -provide a hygienic place for meals; -provide storage for clothing or other belongings; -provide first aid equipment and train a qualified first-aider. • premises: -increase natural ventilation by having more roof and wall openings, windows or open doorways; -move sources of heat, noise, fumes, arc welding, etc., out of the workshop, or install exhaust ventilation, noise barriers, or other solutions; -provide fire extinguishers and train the workers to use them; -clear passageways, provide signs and markings. • work organization: -keep the workers alert and reduce fatigue through frequent changes in tasks, opportunities to change work postures, short breaks, etc.; -have buffer stocks of materials to keep work flow constant; -use quality circles to improve productivity and quality. risk combination of the probability of an event and its consequences. the term "risk" is generally used only when there is at least a possibility of negative consequences. in some situation, risk arises from the possibility of deviation from the expected outcome or event. outcome of an event or a situation, expressed in quality and in quantity. it may result in a loss or in an injury or may be linked to it. the result can be a disadvantage or a gain. in this case the event or the situation is the source. in connection with every analysis it has to be checked whether the cause is given empirically, or follows a set pattern, and whether there is scientific agreement regarding these circumstances. note there can be more than one consequence from one event. note consequences can range from positive to negative. the consequences are always negative from the viewpoint of safety. extent to which an event is likely to occur. note iso - : gives the mathematical definition of probability as "a real number in the interval to attached to a random event. it can be related to a long-run relative frequency of occurrence or to a degree of belief that an event will occur. for a high degree of belief the probability is near ". note frequency rather than probability may be used in describing risk. degrees of belief about probability can be chosen as classes or ranks such as: rare/unlikely/moderate/likely/almost certain, or incredible/improbable/ remote/occasional/probable/frequent. remark: informal language often confuses frequency and probability. this can lead to wrong conclusions in safety technology. probability is the degree of coincidence of the time frequency of coincidental realization of a fact from a certain possibility. coincidence is an event which basically can happen, may be cause-related, but does not occur necessarily or following a set pattern. it may also not occur (yes-or-no-alternative). data for probability of occurring with specific kinds of occurrence and weight of consequences can be: in a statistical sense: empirical, retrospective, real in a prognostic sense: speculative, prospective, probabilistic occurrence of a particular set of circumstances regarding place and time. an event can be the source of certain consequences (empirically to be expected with certain regularity). the event can be certain or uncertain. the event can be a single occurrence or a series of occurrences. the probability associated with the event can be estimated for a given period of time. task range by which the significance of risk is assessed. note risk criteria can include associated costs and benefits, legal and statutory requirements, socio-economic and environmental aspects, the concerns of stakeholders, priorities and other inputs to the assessment. the way in which a stakeholder views a risk based on a set of values or concerns. note risk perception depends on the stakeholder's needs, issues and knowledge. note risk perception can differ from objective data. exchange or sharing of information about risk between the decision-makers and other stakeholders. overall process of risk analysis and risk evaluation. systematic use of information to identify sources and to estimate the risk. note risk analysis provides a basis for risk evaluation, risk treatment, and risk acceptance. note information can include historical data, theoretical analyses, informal opinions, and the concerns of stakeholders. process used to assign figures, values to the probability and consequences of a risk. note risk estimation can consider cost, benefits, the concerns of stakeholders, and other variables, as appropriate for risk evaluation. process of comparing the estimated risk against given risk criteria to determine the significance of a risk. process of selection and implementation of measures to modify risk. note risk treatment measures can include avoiding, optimizing, transferring or retaining risk. actions implementing risk management decisions. note risk control may involve monitoring, re-evaluation, and compliance with decisions. process, related to a risk, to minimize the negative and to maximize the positive consequences (and their respective probabilities). actions taken to lessen the probability, negative consequences or both, associated with a risk. limitation of any negative consequences of a particular event. decision not to become involved in, or action to withdraw from, a risk situation. sharing with another party the burden of loss or benefit of gain, for a risk. note legal or statutory requirements can limit, prohibit or mandate the transfer of a certain risk. note risk transfer can be carried out through insurance or other agreements. note risk transfer can create new risks or modify existing ones. note relocation of the source is not risk transfer. acceptance of the burden of loss, or benefit of gain, from a particular risk. note risk retention includes the acceptance of risks that have not been identified. note risk retention does not include means involving insurance, or transfer in other ways. this includes risk assessment, risk treatment, risk acceptance and risk communication. risk assessment is risk analysis, with identification of sources and risk estimation, and risk evaluation. risk treatment includes avoiding, optimizing, transferring and retaining risk. → risk acceptance → risk communication harm physical injury or damage to the health of people or damage to property or the environment [iso/iec guide ]. note harm includes any disadvantage which is causally related to the infringement of the object of legal protection brought about by the harmful event. note in the individual safety-relevant definitions, harm to people, property and the environment may be included separately, in combination, or it may be excluded. this has to be stated in the respective scope. potential source of harm [iso/iec guide ]. the term "hazard" can be supplemented to define its origin or the nature of the possible harm, e.g., hazard of electric shock, crushing, cutting, dangerous substances, fire, drowning. in every-day informal language, there is insufficient differentiation between source of harm, hazardous situation, hazardous event and risk. circumstance in which people, property or the environment are exposed to one or more hazards [iso/iec guide ]. note circumstance can last for a shorter or longer period of time. event that can cause harm [din en ] . the hazardous event can be preceded by a latent hazardous situation or by a critical event. combination of the probability of occurrence of harm and the severity of that harm [iso/iec guide ]. note in many cases, only a uniform extent of harm (e.g. leading to death) is taken into account, or the occurrence of harm may be independent of the extent of harm, as in a lottery game. in these cases, it is easier to make a probability statement; risk assessment by risk comparison [din en ] thus becomes much simpler. note risks can be grouped in relation to different variables, e.g. to all people or only those affected by the incident, to different periods of time, or to performance. the probabilistic expectation value of the extent of harm is suitable for combining the two probability variables. note risks which arise as a consequence of continuous emission, e.g. noise, vibration, pollutants, are affected by the duration and level of exposure of those affected. risk which is accepted in a given context based on the current values of society [iso/iec guide ]. the acceptable risk has to be taken into account in this context, too. note safety-relevant definitions are oriented to the maximum tolerable risk. this is also referred to as limit risk. note tolerability is also based on the assumption that the intended use in addition to a reasonably predictable misuse of the products, processes and services, is complied with. freedom from unacceptable risk [iso/iec guide ]. note safety is indivisible. it cannot be split into classes or levels. note safety is achieved by risk reduction, so that the residual risk in no case exceeds the maximum tolerable risk. existence of an unacceptable risk. note safety and danger exclude one another -a technical product, process or service cannot be safe and dangerous at the same time. means used to reduce risk [iso/iec guide ]. note protective measures at the product level have priority over protective measures at the workplace level. preventive measure means assumed, but not proven, to reduce risk. risk remaining after safety measures have been taken [din en ] . note residual risk may be related to the use of technical products, processes and services. systematic use of available information to identify hazards and to estimate their risks [iso/iec guide ]. determination of connected risk elements of all hazards as a basis for risk assessment. decision based on the analysis of whether the tolerable risk has been exceeded [iso/iec guide ]. overall process of risk analysis and risk evaluation [iso/iec guide ]. use of a product, process or service in accordance with information provided by the supplier [iso/iec guide ]. note information provided by the supplier also includes descriptions issued for advertising purposes. use of a product, process or service in a way not intended by the supplier, but which may result from readily predictable human behaviour [iso/iec guide ]. safety-related formulation of contents of a normative document in the form of a declaration, instructions, recommendations or requirements [compare en , safety related]. the information set down in technical rules is normally restricted to certain technical relations and situations; in this context, it is presumed that the general safety-relevant principles are followed. a procedure with the aim to reduce risk of a (technical) product, process or service according to the following steps serves to reach the safety goals in the design stage: • safety-related layout; • protective measures; • safety-related information for users. function inevitable to maintain safety. a function which, in case of failure, allows the tolerable risk to be immediately exceeded. depending on the situation, it is possible to use one method or a combination of several methods. intuitive hazard detection spontaneous, uncritical listing of possible hazards as a result of brainstorming by experts. group work which is as creative as possible. writing ideas down (on a flip chart) first, then evaluating them. technical documentation (instructions, requirements) is available for many industrial plant and work processes, describing the hazards and safety measures. this documentation has to be obtained before continuing with the risk analysis. the deviations between the set point and the actual situation of individual components are examined. information on the probability of failure of these elements may be found in technical literature. examining the safety aspects in unusual situations (emergency, repair, starting and stopping) when plans are made to modify the plant or processes. a systematic check of the processes and plant parts for effects in normal operation and in case of set point deviations, using selected question words (and -or -not -too much -too little?). this is used in particular for measurement, control units, programming of computer controls, robots. all possible causes and combinations of causes are identified for an unwanted operating state or an event, and represented in the graphic format of a tree. the probability of occurrence of an event can be estimated from the context. the fault tree analysis can also be used retrospectively to clarify the causes of events. additional methods may be: human reliability analysis a frequency analysis technique which deals with the behaviour of human beings affecting the performance of the system, and estimates the influence of human error on reliability. a hazard identification and frequency analysis technique which can be used at an early stage in the design phase to identify and critically evaluate hazards. operating safety block program a frequency analysis technique which utilizes a model of the system and its redundancies to evaluate the operating safety of the entire system. classifying risks into categories, to establish the main risk groups. all typical hazardous substances and/or possible accident sources which have to be taken into account are listed. the checklist may be used to evaluate the conformity with codes and standards. this method is used to estimate whether coincidental failures of an entire series of different parts or modules within a system are possible and what the probable effects would be. estimate the influence of an event on humans, property or the environment. simplified analytical approaches, as well as complex computer models can be used. a large circle of experts is questioned in several steps; the result of the previous step together with additional information is communicated to all participants. during the third or fourth step the anonymous questioning concentrates on aspects on which no agreement is reached so far. basically this technique is used for making predictions, but is also used for the development of new ideas. this method is particularly efficient due to its limitation to experts. a hazard identification and evaluation technique used to establish a ranking of the different system options and to identify the less hazardous options. a frequency analysis technique in which a model of the system is used to evaluate variations of the input conditions and assumptions. a means to estimate and list risk groups; reviews risk pairs and evaluates only one risk pair at a time. overview of data from the past a technique used to identify possible problem areas; can also be used for frequency analysis, based on accident and operation safety data, etc. a method to identify latent risks which can cause unforeseeable incidents. cssr differs from the other methods in that it is not conducted by a team, and can be conducted by a single person. the overview points out essential safety and health requirements related to a machine and simultaneously to all relevant (national, european, international) standards. this information ensures that the design of the machine complies with the issued "state of the art" for that particular type of machine. the "what-if" method is an inductive procedure. the design and operation of the machine in question are examined for fairly simple applications. at every step "what-if" questions are asked and answered to evaluate the effect of a failure of the machine elements or of process faults in view of the hazards caused by the machine. for more complex applications, the "what-if" method is most useful with the aid of a "checklist" and the corresponding work division to allocate specific features of the process to persons who have the greatest experience and practice in evaluating the respective feature. the operator's behaviour and professional knowledge are assessed. the suitability of the equipment and design of the machine, its control unit and protective devices are evaluated. the influence of the materials processed is examined, and the operating and maintenance records are checked. the checklist evaluation of the machine generally precedes the more detailed methods described below. fmea is an inductive method for evaluating the frequency and consequences of component failure. when operating procedures or operator errors are investigated, then other methods may be more suitable. fmea can be more time-consuming than the fault tree analysis, because every mode of failure is considered for every component. some failures have a very low probability of occurrence. if these failures are not analyzed in depth this decision should be recorded in the documentation. the method is specified in iec "analysis techniques for system reliability -procedure for failure mode and effects analysis (fmea)". in this inductive method, the test procedures are based on two criteria: technology and complexity of the control system. mainly, the following methods are applicable: • practical tests of the actual circuit and fault simulation on certain components, particularly in suspected areas of performance identified during the theoretical check and analysis. • simulation of control behaviour (e.g. by means of hardware and/or software models). whenever complex safety-related parts of control systems are tested, it may be necessary to divide the system into several functional sub-systems, and to exclusively submit the interface to fault simulation tests. this technique can also be applied to other parts of machinery. mosar is a complete approach in steps. the system to be analyzed (machinery, process, installation, etc.) is examined as a number of sub-systems which interact. a table is used to identify hazards and hazardous situations and events. the adequacy of the safety measures is studied with a second table, and a third table is used to look at their interdependency. a study, using known tools (e.g. fmea) underlines the possible dangerous failures. this leads to the elaboration of accident scenarios. by consensus, the scenarios are sorted in a severity table. a further table, again by consensus, links the severity with the targets of the safety measures, and specifies the performance levels of the technical and organizational measures. the safety measures are then incorporated into the logic trees and the residual risks are analyzed via an acceptability table defined by consensus. ilo ( ) , , , , , the risks to health at work are numerous and originate from several sources. their origins vary greatly and they cause vast numbers of diseases, injuries and other adverse conditions, such as symptoms of overexertion or overload. traditional occupational health risk factors and their approximate numbers are given in table . . the exposure of workers to hazards or other adverse conditions of work may lead to health problems, manifested in the workers' physical health, psysical workload, psychological disturbances or social aspects of life. workers may be exposed to various factors alone or in different types of combinations, which may or may not show interaction. the assessment of interacting risk factors is complex and may lead to substantial differences in the final risk estimates when compared with estimates of solitary factors. examples of interaction between different risk factors in the work environment are given in table . . the who estimate of the total number of occupational diseases among the billion workers of the world is million a year. this is likely to be an under-estimate due to the lack of diagnostic services, limited legislative coverage of both workers and diseases, and variation in diagnostic criteria between different parts of the world. the mortality from occupational diseases is substantial, comparable with other major diseases of the world population such as malaria or tuberculosis. the recent ilo estimate discloses . million deaths a year from work-related causes in the world including deaths from accidents, dangerous substances, and occupational diseases. eightyfive percent ( %) of these deaths take place in developing countries, where the diagnostic services, social security to families and compensation to workers are less developed. although the risk is decreasing in the industrialized world, the trend is increasing in the rapidly industrializing and transitory countries. a single hazard alone, such as asbestos exposure, is calculated to cause , cancers a year with a fatal outcome in less than two years after diagnosis (takala ). the incidence rates of occupational diseases in well registered industrialized countries are at the level of - cases/ , active employees/year, i.e., the incidence levels are comparable with major public health problems, such as cardiovascular diseases, respiratory disorders, etc. in the industrialized countries, the rate of morbidity from traditional occupational diseases, such as chemical poisonings, is declining, while musculoskeletal and allergic diseases are on the increase. about biological factors that are hazardous to workers' health have been identified in various work environments. some of the new diseases recognized are blood-borne infections, such as hepatitis c and hiv, and exotic bacterial or viral infections transmitted by increasing mobility, international travelling and migration of working people. also some hospital infections and, e.g., drug-resistant tuberculosis, are being contracted increasingly by health care personnel. in the developing countries the morbidity picture of occupational diseases is much less clear for several reasons: low recognition rates, rotation and turnover of workers, shorter life expectancy which hides morbidity with a long latency period, and the work-relatedness of several common epidemic diseases, such as malaria and hiv/aids (rantanen ). the estimation of so-called work-related diseases is even more difficult than that of occupational diseases. they may be about -fold more prevalent than the definite occupational diseases. several studies suggest that siegfried radandt, jorma rantanen and ortwin renn work-related allergies, musculoskeletal disorders and stress disorders are showing a growing trend at the moment. the prevention of work-related diseases is important in view of maintaining work ability and reducing economic loss from absenteeism and premature retirement. the proportion of work-relatedness out of the total morbidity figures has been estimated and found surprisingly high (nurminen and karjalainen , who ) (see table . ). the public health impact of work-related diseases is great, due to their high prevalence in the population. musculoskeletal disorders are among the three most common chronic diseases in every country, which implies that the attribution of work is very high. similarly, cardiovascular diseases in most industrialized countries contribute to % of the total mortality. even a small attributable fraction of work-relatedness implies high rates of morbidity and mortality related to work. the concept of disease is in general not a simple one. when discussing morbidity one has to recognize three different concepts: . illness = an individual's perception of a health problem resulting from either external or internal causes. . disease = an adverse health condition diagnosed by a doctor or other health professional. . sickness = a socially recognized disease which is related to, for example, social security actions or prescription of sick leave, etc. when dealing with occupational and work-related morbidity, one may need to consider any of the above three aspects of morbidity. a recognized occupational disease, however, belongs to group , i.e. it is a sickness defined by legal criteria. medical evidence is required to show that the condition meets the criteria of an occupational disease before recognition can be made. there are dozens of definitions for occupational disease. the content of the concept varies, depending on the context: a) the medical concept of occupational disease is based on a biomedical or other health-related etiological relationship between work and health, and is used in occupational health practice and clinical occupational medicine. b) the legal concept of occupational disease defines the disease or conditions which are legally recognized as conditions caused by work, and which lead to liabilities for recognition, compensation and often also prevention. the legal concept of occupational disease has a different background in different countries, often declared in the form of an official list of occupational diseases. there is universal discrepancy between the legal and medical concept, so that in nearly all countries the official list of recognized occupational diseases is shorter than the medically established list. this automatically implies that a substantial proportion of medically established occupational diseases remain unrecognized, unregistered, and consequently also uncompensated. the definition of occupational disease, as used in this chapter, summarizes various statements generated during the history of occupational medicine: an occupational disease is any disease contracted as a result of exposures at work or other conditions of work. the general criteria for the diagnosis and recognition of an occupational disease are derived from the core statements of various definitions: . evidence on exposure(s) or condition(s) in work or the work environment, which on the basis of scientific knowledge is (are) able to generate disease or some other adverse health condition. . evidence of symptoms and clinical findings which on the basis of scientific knowledge can be associated with the exposure(s) or condition(s) in concern. . exclusion of non-occupational factors or conditions as a main cause of the disease or adverse health condition. point often creates problems, as several occupationally generated clinical conditions can be caused also by non-occupational factors. on the other hand, several factors from different sources and environments are involved in virtually every disease. therefore the wordings "main cause" or "principal cause" are used. the practical solution in many countries is that the attribution of work needs to be more than %. usually the necessary generalizeable scientific evidence is obtained from epidemiological studies, but also other types of evidence, e.g. well documented clinical experience combined with information on working conditions may be acceptable. in some countries, like finland, any disease of the worker which meets the above criteria can be recognized as an occupational disease. in most other countries, however, there are official lists of occupational diseases which determine the conditions and criteria on which the disease is considered to be of occupational origin. in who launched a new concept: work-related disease (who ) . the concept is wider than that of an occupational disease. it includes: a) diseases in which the work or working conditions constitute the principal causal factor. b) diseases for which the occupational factor may be one of several causal agents, or the occupational factor may trigger, aggravate or worsen the disease. c) diseases for which the risk may be increased by work or work-determined lifestyles. the diseases in category (a) are typically recognized as legally determined occupational diseases. categories (b) and (c) are important regarding the morbidity of working populations, and they are often considered as important targets for prevention. in general, categories (b) and (c) cover greater numbers of people, as the diseases in question are often common noncommunicable diseases of the population, such as cardiovascular diseases, musculoskeletal disorders, and allergies and, to a growing extent, stressrelated disorders (see table . ). the concept of work-related disease is very important from the viewpoint of occupational health risk assessment and the use of its results for preventive purposes and for promoting health and safety at work. this is because preventive actions in occupational health practice cannot be limited only to legally recognized morbidity. the lists of occupational diseases contain great numbers of agents that show evidence on occupational morbidity. according to the ilo recommendation r ( ): list of occupational diseases, the occupational diseases are divided into four main categories: . diseases resulting from single causes following the categories listed in table . . the most common categories are physical factors, chemical agents, biological factors and physical work, including repetitive tasks, poor ergonomic conditions, and static and dynamic work. . diseases of the various organs: respiratory system, nervous system, sensory organs, internal organs, particularly liver and kidneys, musculoskeletal system, and the skin. . occupational cancers. . diseases caused by other conditions of work. research on risk perception shows differences in how different types of risks are viewed. instant, visible, dramatic risk events, particularly ones that cause numerous fatalities or severe visible injuries in a single event generally arouse much attention, and are given high priority. on the other hand, even great numbers of smaller events, such as fatal accidents of single workers, arouse less attention in both the media and among regulators, even though the total number of single fatal accidents in a year may exceed the number of fatalities in major events by several orders of magnitude. occupational diseases, with the exception of a few acute cases, are silent, develop slowly, and concern only one or a few individuals at a time. furthermore, the diseases take months or years to develop, in extreme cases even decades, after the exposure or as a consequence of accumulation of exposure during several years. as occupational health problems are difficult to detect and seriously under-diagnosed and under-reported, they tend to be given less priority than accidents. the perception of occupational disease risk remains low in spite of their severity and relatively high incidence. particularly in industrialized countries, the extent of occupational health problems is substantially greater than that of occupational accidents. on a global scale, the estimated number of fatalities due to occupational accidents is , and the respective estimate for fatalities due to work-related diseases is . million a year, giving a fatal accident/fatal disease ratio of to . the corresponding ratio in the eu- is to (takala ). the risk distribution of ods is principally determined by the nature of the work in question and the characteristics of the work environment. there is great variation in the risk of ods between the lowest and highest risk occupations. in the finnish workforce, the risk between the highest risk and the lowest risk occupations varies by a factor of . the highest risk occupations carry a risk which is - times higher than the average for all occupations. the risk of an occupational disease can be estimated on the basis of epidemiological studies, if they do exist in the case of the condition in question. on the other hand, various types of economic activity, work and occupations carry different types of risks, and each activity may have its own risk profile. by examining the available epidemiological evidence, we can recognize high-risk occupations and characterize the typical risks connected with them ( figure . , table . ). as an example, the risk of occupational asthma, dermatosis or musculoskeletal disorders is common in several occupations, but not in all. there may be huge differences in risks between different occupations. the occupations carrying the highest risk for occupational asthma, occupational skin diseases and work-related tenosynovitis, in - , are shown in table . . assessment of the risk of occupational diseases has an impact on research priorities. table . shows the priorities for research in four countries. the similarity of the priorities is striking, revealing that the problems related to the risks of occupational diseases are universal. the diagnosis of occupational diseases is important for the treatment of the disease, and for prevention, registration and compensation. the diagnosis is based on information obtained from: a) data on the work and the work environment usually provided by the employer, occupational health services, occupational safety committee, or expert bodies carrying out hygienic and other services for the workplace. b) information on the health examination of individual workers. the authorities in many countries have stipulated legal obligations for high-risk sectors to follow up the workers' health and promote early detection of changes in their health. occupational health services keep records on examinations. c) workers with special symptoms (for example, asthmatic reactions) are taken into the diagnostic process as early as possible. epidemiological evidence is a critical prerequisite for recognizing causal relationship between work and disease. epidemiology is dependent on three basic sources of information on work and the work environment: (a) exposure assessment that helps to define the "dose" of risk factor at work, (b) the outcome assumed to occur as a biological (or psychological) response to the exposures involved, and (c) time, which has a complex role in various aspects of epidemiology. all these sources are affected by the current dynamics of work life which has major impact on epidemiological research and its results. exposure assessment is the critical initial step in risk assessment. as discussed in this chapter, accurate exposure assessment will become more difficult and cumbersome than before in spite of remarkable achievements in measurement, analysis and monitoring methods in occupational hygiene, toxicology and ergonomics. great variations in working hours and individu-alization of exposures, growing fragmentation and mobility increase the uncertainties, which are multiplied. structural uncertainty, measurement uncertainty, modelling uncertainty, input data uncertainty and natural uncertainty amplify each other. as a rule, variation in any direction in exposure assessment tends to lead to underestimation of risk, and this has severe consequences to health. personal monitoring of exposures, considering variations in individual doses, and monitoring internal doses using biological monitoring methods help in the control of such variation. a monofactorial exposure situation in the past was ideal in the assessment because of its manageability. it also occurs usually as a constant determinant for long periods of time and can be regularly and continuously measured and monitored. this is very seldom the case today, and exposure assessment in modern work life is affected by discontinuities of the enterprise, of technologies and production methods, and turnover of the workforce, as well as the growing mobility and internationalization of both work and workers. company files that were earlier an important source of exposure and health data no longer necessarily fulfil that function. in addition, the standard -h time-weighted average for exposure assessment can no longer be taken as a standard, as working hours are becoming extremely heterogeneous. assessment of accurate exposure is thus more and more complex and cumbersome, and new strategies and methods for the quantification of exposure are needed. three challenges in particular can be recognized: a) the challenge arising from numerous discontinuities, fragmentation and changes in the company, employment and technology. although in the past company data were collected from all sources that were available, collective workroom measurements were the most valuable source of data. due to the high mobility of workers and variation in the work tasks, personal exposure monitoring is needed that follows the worker wherever he or she works. special smart cards for recording all personal exposures over years have been proposed, but so far no system-wide action has been possible. in radiation protection, however, such a personal monitoring system has long been a routine procedure. b) the complex nature of exposures where dozens of different factors may be involved (such as those in indoor air problems) and acting in combinations. table . gives a list of exposing factors in modern work life, many of which are difficult to monitor. c) new, rapidly spreading and often unexpected exposures that are not well characterized. often their mechanisms of action are not known, or the fast spread of problems calls for urgent action, as in the case of bovine spongiform encephalopathy (bse) in the s, sars outbreak in , and in the new epidemics of psychological stress or musculoskeletal disorders in modern manufacturing. the causes of occupational diseases are grouped into several categories by the type of factor (see table . ). a typical grouping is the one used in ilo recommendation no. . the lists of occupational diseases contain diseases caused by one single factor only, but also diseases which may have been caused by multifactorial exposures. exposure assessment is a crucial step in the overall risk assessment. the growing complexity of exposure situations has led to the development of new methods for assessing such complex exposure situations. these methods are based on construction of model matrices for jobs which have been studied thoroughly for their typical exposures. the exposure profiles are illustrated in job exposure matrices (jem) which are available for dozens of occupations (heikkilä et al. , guo . several factors can cause occupational diseases. the jem is a tool used to convert information on job titles into information on occupational risk factors. jem-based analysis is economical, systematic, and often the only reasonable choice in large retrospective studies in which exposure assessment at the individual level is not feasible. but the matrices can also be used in the practical work for getting information on typical exposure profiles of various jobs. the finnish national job-exposure matrix (finjem) is the first and so far the only general jem that is able to give a quantitative estimation of cumulative exposure. for example, finjem estimates were used for exposure profiling on chemical exposures and several other cancer-risk factors for occupational categories. the jem analysis has been further developed into task specific exposure matrices charting the exposure panorama of various tasks (benke et al. (benke et al. , . as the previous mono-causal, mono-mechanism, mono-outcome setting has shifted in the direction of multicausality, multiple mechanisms and multioutcomes, the assessment of risks has become more complex. some outcomes, as mentioned above, are difficult to define and measure with objective methods and some of them may be difficult to recognize by exposed groups themselves, or even by experts and researchers. for example, the objective measurement of stress reactions is still imprecise in spite of improvements in the analysis of some indicator hormones, such as adrenalin, noradrenalin, cortisol, prolactin, or in physical measurements, such as galvanic skin resistance and heart rate variability. questionnaires monitoring perceived stress symptoms are still the most common method for measuring stress outcomes. thanks to well organized registries, particularly in germany and the nordic countries, data on many of the relevant outcomes of exposure, such as cancer, pneumoconiosis, reproductive health disturbances and cardiovascular diseases can be accumulated, and long-term follow-up of outcomes at the group level is therefore possible. on the other hand, several common diseases, such as cardiovascular diseases, may have a work-related aetiology, but it may be difficult to show at individual level. the long-term data show that due to changes in the structure of economies, types of employment, occupational structures and conditions of work, many of the traditional occupational diseases, such as pneumoconiosis and acute intoxications have almost disappeared. several new outcomes have appeared, however, such as symptoms of physical or psychological overload, psychological stress, problems of adapting to a high pace of work, and uncertainty related to rapid organizational changes and risk of unemployment. in addition, age-related and work-related diseases among the ageing workforce are on the increase (kivimäki et al. , ilmarinen . these new outcomes may have a somatic, psychosomatic or psychosocial phenotype, and they often appear in the form of symptoms or groups of symptoms instead of well-defined diagnoses. practising physicians or clinics are not able to set an icd (international statistical classification of diseases and health-related conditions)-coded diagnosis for them. in spite of their diffuse nature, they are still problems for both the worker and the enterprise, and their consequences may be seen as sickness absenteeism, premature retirement, loss of job satisfaction, or lowered productivity. thus, they may have even a greater impact on the quality of work life and the economy than on clinical health. many such outcomes have been investigated by using questionnaire surveys among either representative samples of the whole workforce or by focusing the survey on a specific sector or occupational group. the combination of data from the surveys of "exposing factors", such as organizational changes, with questionnaire surveys of "outcomes", such as sickness absenteeism, provides epidemiological information on the association between the new exposures and the new outcomes. there are, however, major problems in both the accurate measurement of the exposures and outcomes, and also, the information available on the mechanisms of action is very scarce. epidemiology has expanded the focus of our observations from crosssectional descriptions to longitudinal perspectives, by focussing attention on the occurrence of diseases and finding associations between exposure and morbidity. such an extension of vision is both horizontal and vertical, looking at the causes of diseases. time is not only a temporal parameter in epidemiology, but has also been used for the quantification of exposure, measurement of latencies, and the detection of acceleration or slowing of the course of biological processes. as the time dimension in epidemiology is very important, the changes in temporal parameters of the new work life also affect the methods of epidemiological research. the time dimension is affected in several ways. first, the fragmentation and discontinuities of employment contracts, as described above, break the accumulation of exposure time into smaller fragments, and continuities are thus difficult to maintain. collecting data on cumulative exposures over time becomes more difficult. the time needed for exposure factors to cause an effect becomes more complex, as the discontinuities typical to modern work life allow time for biological repair and elimination processes, thus diluting the risk which would get manifested from continuous exposure. the dosage patterns become more pulse-type, rather than being continuous, stable level exposures. this may affect the multi-staged mechanisms of action in several biological processes. the breaking up of time also increases the likelihood of memory bias of respondents in questionnaire studies among exposed workers, and thus affects the estimation of total exposures. probably the most intensive effect, however, will be seen as a consequence of the variation in working hours. for example, instead of regular work of hours per day, hours per week and months per year, new time schedules and total time budgets are introduced for the majority of workers in the industrial society. the present distribution of weekly working hours in finland is less than hours per week for one third of workers, regular - hours per week for one third, and - hours per week for the remaining third. thus the real exposure times may vary substantially even among workers in the same jobs and same occupations, depending on the working hours and the employment contract (temporary, seasonal, part-time, full-time) (härmä , piirainen et al. . such variation in time distribution in "new work life" has numerous consequences for epidemiological studies, which in the past "industrial society" effectively utilized the constant time patterns at work for the assessment of exposures and outcomes and their interdependencies. the time dimension also has new structural aspects. as biological processes are highly deterministic in terms of time, the rapid changes in work life cannot wait for the maturation of results in longitudinal follow-up studies. the data are needed rapidly in order to be useful in the management of working conditions. this calls for the development of rapid epidemiological methods which enable rapid collection of the data and the making of analyses in a very short time, in order to provide information on the effects of potential causal factors before the emergence of a new change. often these methods imply the compromising of accuracy and reliability for the benefit of timeliness and actuality. as occupational epidemiology is not only interested in acute and short-term events, but looks at the health of workers over a - -year perspective, the introduction of such new quick methods should not jeopardize the interest and efforts to carry out long-term studies. epidemiology has traditionally been a key tool in making a reliable risk assessment of the likelihood of the adverse outcomes from certain levels of exposure. the new developments in work life bring numerous new challenges to risk assessment. as discussed above, the new developments in work life have eliminated a number of possibilities for risk assessment which prevailed in the stable industrial society. on the other hand, several new methods and new information technologies provide new opportunities for collection and analysis of data. traditionally, the relationship between exposure and outcome has been judged on the basis of the classical criteria set by hill ( ) . höfler ( ) crystallizes the criteria with their explanations as the following: . strength of association: a strong association is more likely to have a causal component than is a modest association. . consistency: a relationship is observed repeatedly. . specificity: a factor influences specifically a particular outcome or population. . temporality: the factor must precede the outcome it is assumed to affect. ing dose of exposure or according to a function predicted by a substantive theory. . plausibility: the observed association can be plausibly explained by substantive matter (e.g. biological) explanations. . coherence: a causal conclusion should not fundamentally contradict present substantive knowledge. . experiment: causation is more likely if evidence is based on randomized experiments. . analogy: for analogous exposures and outcomes an effect has already been shown. the hill criteria have been subjected to scrutiny, and sven hernberg has analyzed them in detail from the viewpoint of occupational health epidemiology. virtually all the hill criteria are affected by the changes in the new work life, and therefore methodological development is now needed. a few comments on causal inference are made here in view of the critiques by rothman ( ), hernberg ( ) and höfler ( ) : the strength of association will be more difficult to demonstrate due to the growing fragmentation that tends to diminish the sample sizes. the structural change that removes workers from high-level exposures to lower and shorterterm exposures may dilute the strength of effect, which may still prevail, but at a lower level. consistency of evidence may also be affected by the higher variation in conditions of work, study groups, multicultural and multiethnic composition of the workforce, etc. similarly, in the multifactorial, multi-mechanism, multi-outcome setting, the specificity criterion is not always relevant. the temporal dimension has already been discussed. in rapidly changing work life the follow-up times before the next change and before turnover in the workforce may be too short. the outcomes may also be defined by the exposures that have taken place long ago but have not been considered in the study design because historical data are not available. the biological gradient may be possible to demonstrate in a relatively simple exposure-outcome relationship. however, the more complex and multifactorial the setting becomes, the more difficult it may be to show the doseresponse relationship. the dose-response relationship may also be difficult to demonstrate in the cases of relatively ill-defined outcomes which are difficult to measure, but which can be detected as qualitative changes. biological plausibility is an important criterion which in a multimechanism setting may at least in part be difficult to demonstrate. on the other hand, the mechanisms of numerous psychological and psychosocial outcomes lack explanations, even though they undoubtedly are work-related. the missing knowledge of the mechanism of action did not prevent the establishment of causality between asbestos and cancer in a pleural sack or a lung. as many of the new outcomes may be context-dependent, the coherence criterion may be irrelevant. similarly, many of the psychosocial outcomes are difficult to put into an experimental setting, and it can be difficult to make inferences based on analogy. all of the foregoing implies that the new dynamic trends in work life challenge epidemiology in a new way, particularly in the establishment of causality. knowledge of causality is required for the prevention and management of problems. the hill criteria nevertheless need to be supplemented with new ones to meet the conditions of the new work life. similarly, more definitive and specific criteria and indicators need to be developed for the new exposures and outcomes. many of the challenges faced in the struggle to improve health and safety in modern work life can only be solved with the help of research. research on occupational health in the rapidly changing work life is needed more than ever. epidemiology is, and will remain, a key producer of information needed for prevention policies and for ensuring healthy and safe working conditions. the role of epidemiology is, however, expanding from the analysis of the occurrence of well-defined clinical diseases to studies on the occurrence of several other types of exposure and outcome, and their increasingly complex associations. as the baseline in modern work life is shifting in a more dynamic direction, and many parameters in work and the workers' situation are becoming more fragmented, incontinuous and complex, new approaches are needed to tackle the uncertainties in exposure assessment. the rapid pace of change in work life calls for the development of assessment methods to provide up-todate data quickly, so that they can be used to manage these changes and their consequences. many new outcomes which are not possible to register as clinical icd diagnoses constitute problems for today's work life. this is particularly true in the case of psychological, psychosocial and many musculoskeletal outcomes which need to be managed by occupational health physicians. methods for the identification and measurement of such outcomes need to be improved. the traditional hill criteria for causal inference are not always met even in cases where true association does exist. new criteria suitable for a new situation should be established without jeopardizing the original objective of ascertaining the true association. developing the bayesian inference further through utilization of a priori knowledge and a holistic approach may provide responses to new challenges. new neural network softwares may help in the management of the growing complexity. the glory of science does not lie in the perfection of a scientific method but rather in the recognition of its limitations. we must keep in mind the old saying: "absence of evidence is not evidence of absence". instead, it is merely a consequence of our ignorance that should be reduced through further efforts in systematic research, and particularly through epidemiology. and secondly, the ultimate value of occupational health research will be determined on the basis of its impact on practice in the improvement of the working conditions, safety and health of working people. changing conditions of work, new technologies, new substances, new work organizations and working practices are associated with new morbidity patterns and even with new occupational and work-related diseases. the new risk factors, such as rapidly transforming microbials and certain social and behavioural "exposures" may follow totally new dynamics when compared with the traditional industrial exposures (self-replicating nature of microbials and spreading of certain behaviours, such as terrorism) (smolinski et al. , loza . several social conditions, such as massive rural-urban migration, increased international mobility of working people, new work organizations and mobile work may cause totally new types of morbidity. examples of such development are, among others, the following: • mobile transboundary transportation work leading to the spread of hiv/aids. • increased risk of metabolic syndrome, diabetes and cardiovascular diseases aggravated by unconventional working hours. • increased risk of psychological burnout in jobs with a high level of longterm stress. • virtually a global epidemic of musculoskeletal disorders among vdu workers with high work load, psychological stress and poor ergonomics. the incidences of occupational diseases may not decline in the future, but the type of morbidity may change. the direction of trend in industrialized countries is the prominence of work-related morbidity and new diseases, while the traditional occupational diseases such as noise injury, pneumoconiosis, repetitive strain and chemical intoxications may continue to be prevalent in developing countries for long periods in the future. the new ergonomics problems are related to light physical work with a considerable proportion of static and repetitive workload. recent research points to an interesting interaction between unergonomic working conditions and psychological stress, leading to a combined risk of musculoskeletal disorders of the neck, shoulders and upper arms, including carpal tunnel syndrome in the wrist. the muscle tension in static work is amplified by the uncontrolled muscular tension caused by psychological stress. furthermore, there seems to be wide inter-individual variation in the tendency to respond with spasm, particularly in the trapezius muscle of neck, under psychological stress. about % of the health complaints of working-aged people are related to musculoskeletal disorders, of which a substantial part is work-related. the epidemics have been resistant against preventive measures. new regulatory and management strategies may be needed for effective prevention and control measures (westgaard et al. , paoli and merllié ) . the st century will be the era of the brain at work and consequently of psychological stress. between % and % of eu workers in certain occupations report psychological stress due to high time pressure at work (parent-thirion et al. ). the occurrence of work-related stress is most prevalent in occupations with tight deadlines, pressure from clients, or the high level of responsibility for productivity and quality given to the workers. undoubtedly, the threat of unemployment increases the perception of stress as well. as a consequence, for example, in finland some % of workers report symptoms of psychological overload and about % show clinical signs of burn out. these are not the problems of low-paid manual workers only, but also, for example, highly educated and well-paid computer super-experts have an elevated risk of burnout as a consequence of often self-committed workload (kalimo and toppinen ) . unconventional and ever longer working hours are causing similar problems. for example, one third of finns work over hours a week, and of these % work over hours, and % often work - hours per week. it is important to have flexibility in the work time schedules, but it is counterproductive if the biologically determined physiological time rhythms of the worker are seriously offended. over % have a sleep deficit of at least one hour each day, and % are tired and somnolent at work (härmä et al. ) . the toughening global competition, growing productivity demands and continuous changes of work, together with job insecurity, are associated with increased stress. up to - % of workers in different countries and different sectors of the economy report high time pressure and tight deadlines. this prevents them from doing their job as well as they would like to, and causes psychological stress. psychological stress is particularly likely to occur if the high demands are associated with a low degree of self-regulation by the workers (houtman ) . stress, if continuous, has been found to be detrimental to physical health (cardiovascular diseases), mental health (psychological burnout), safety (accident risks), and musculoskeletal disorders (particularly hand-arm and shoulder-neck disorders). it also has a negative impact on productivity, sickness absenteeism, and the quality of products and services. the resulting economic losses due to sickness absenteeism, work disability and lower quality of products and services are substantial. the prevention of stress consists not only of actions targeted at the individual worker. there is also a need for measures directed at the work organization, moderation of the total workload, competence building and collaboration within the workplace (theorell ). the support from foremen and supervisors is of crucial importance in stress management programmes. another type of psychological burden is the stress arising from the threat of physical violence or aggressive behaviour from the part of clients. in finland some % of workers have been subjected to insults or the threat of physical violence, % have experienced sexual harassment, and % mental violence or bullying at work. the risk is substantially higher for female workers than for men. stress has been found to be associated with somatic health, cardiovascular diseases, mental disorders and depression. one of the new and partly re-emerging challenges of occupational health services is associated with the new trends in microbial hazards. there are several reasons for these developments, for instance, the generation of new microbial strains, structural changes in human habitations with high population densities, growing international travel, and changes possibly in our microbiological environment as a consequence of global warming. of the to million species in the world, about million are microbes. the vast majority of them are not pathogenic to man, and we live in harmony and symbiosis with many of them. we also use bacteria in numerous ways to produce food, medicines, proteins, etc. the pathogenic bacteria have been well controlled in the th century; this control had an enormous positive impact on human health, including occupational health. but now the microbial world is challenging us in many ways. new or re-emerging biological hazards are possible due to the transformation of viruses, the increased resistance of some microbial strains (e.g. tuberculosis and some other bacterial agents) and the rapid spread of contaminants through extensive overseas travelling (smolinski et al. ) . the scenarios of health hazards from the use of genetically manipulated organisms have not been realized, but biotechnological products have brought along new risks of allergies. a major indoor air problem is caused by fungi, moulds and chemical emissions from contaminated construction materials. new allergies are encountered as a consequence of the increasingly allergic constitution of the population and of the introduction of new allergens into the work environment. health care personnel are increasingly exposed to new microbial hazards due to the growing mobility of people. evidence of high rates of hepatitis b antigen positivity has been shown among health care workers who are in contact with migrants from endemic areas. along with the growing international interactions and mobility, a number of viral and re-emerging bacterial infections also affect the health of people engaged in health care and the care of the elderly, as well as personnel in migrant and refugee services, in social services and other public services. this section applies the general framework for risk governance (chapter ) to the area of environmental risks. why should we include this topic in a book that is dominantly dealing with occupational health risks and safety issues? there are two major reasons for this decision: . most risks that impact health and safety of human beings are also affecting the natural environment. it is therefore necessary for risk managers to reflect the consequences of risk-taking activities with respect to workers, the public and the environment. these risk consequences are all interconnected. our approach to foster an integral approach to risk and risk management requires the integration of all risk consequences. . environmental risks are characterized by many features and properties that highlight exemplary issues for many generic risk assessment and management questions and challenges. for example, the question of how to balance benefits and risks becomes more accentuated, if not human life, but damage to environmental quality is at stake. while most people agree that saving human lives takes priority over economic benefits, it remains an open question of how much environmental change and potential damage one is willing to trade off against certain economic benefits. this section is divided into two major parts. part will introduce the essentials of environmental ethics and the application of ethical principles to judging the acceptability of human interventions into the environment. part addresses the procedures for an analytic-deliberative process of decision making when using the risk governance framework developed in chapter . it should be noted that this section draws from material that the author has compiled for the german scientific council for global environmental change and that has been partially published in german in a special report of the council (wbgu ). the last section on decision making has borrowed material from an unpublished background document on decision making and risk management that dr. warner north and the author had prepared for the us national academy of sciences. should people be allowed to do everything that they are capable of doing? this question is posed in connection with new technologies, such as nanotubes, or with human interventions in nature, such as the clearance of primaeval forests so that the land can be used for agriculture. intuitively everyone answers this question with a definitive "no": no way should people be allowed to everything that they are capable of doing. this also applies to everyday actions. many options in daily life, from lying to minor deception, from breaking a promise up to going behind a friend's back, are obviously actions that are seen by all well-intentioned observers as unacceptable. however, it is much more difficult to assess those actions where the valuation is not so obvious. is it justified to break a promise when keeping the promise could harm many other people? actions where there are conflicts between positive and negative consequences or where a judgement could be made one way or the other with equally good justification are especially common in risk management. there is hardly anyone who wilfully and without reason pollutes the environment, releases toxic pollutants or damages the health of individuals. people who pursue their own selfish goals on the cost and risk of others are obviously acting wrongly and every legislator will sanction this behaviour with the threat of punishment or a penalty. but there is a need for clarification where people bring about a benefit to society with the best intentions and for plausible reasons and, in the process, risk negative impacts on others. in ethics we talk about "conflicting values" here. most decisions involving risks to oneself or others are made for some reason: the actors who make such interventions want to secure goods or services to consumers, for example, to ensure long-term jobs and adequate incomes, to use natural resources for products and services or to use nature for recycling waste materials from production and consumption that are no longer needed. none of this is done for reasons of brotherly love, but to maintain social interests. even improving one's own financial resource is not immoral mere for this reason. the list of human activities that pose risks onto others perpetrated for existential or economic reasons could be carried on into infinity. human existence is bound to taking opportunities and risks. here are just a few figures: around , years ago about million people lived on the earth. under the production conditions those days (hunter-gatherer culture) this population level was the limit for the human species within the framework of an economic form that only interfered slightly with man's natural environment. the neolithic revolution brought a dramatic change: the carrying capacity of the world for human beings increased by a factor of and more. this agrarian pre-industrial cultural form was characterized by tightly limited carrying capacity, in around the earth was capable of feeding approx. million people. today the world supports billion people -and this figure is rising. the carrying capacity in comparison to the neolithic age has thus increased thousand-fold and continues to grow in parallel to new changes in production conditions (fritsch ; kesselring ; mohr ) . the five "promethean innovations" are behind this tremendous achievement of human culture: mastering fire, using the natural environment for agriculture, transforming fossil fuels into thermal and mechanical energy, industrial production and substituting material with information (renn ) . with today's settlement densities and the predominantly industrial way of life, the human race is therefore dependent on the technical remodelling of nature. without doubt, it needs this for survival, especially for the well-being of the innumerable people, goods and services that reduce the stock of natural resources. with regard to the question of the responsibility of human interventions in nature, the question cannot be about "whether" but -even better -about "how much", because it is an anthropological necessity to adapt and shape existing nature to human needs. for example, the philosopher klaus michael meyer-abich sees the situation as follows: ". . . we humans are not there to leave the world as though we had never been there. as with all other life forms, it is also part of our nature and our lives to bring about changes in the world. of course, this does not legitimise the destructive ways of life that we have fallen into. but only when we basically approve of the changes in the world can we turn to the decisive question of which changes are appropriate for human existence and which are not" (meyer-abich ). therefore, to be able to make a sensible judgement of the balance between necessary interventions into the environment and the risks posed by these interventions to human health and environmental quality, the range of products and services created by the consumption of nature has to be considered in relation to the losses that are inflicted on the environment and nature. with this comparison, it can be seen that even serious interventions in nature and the environment did not occur without reflection, but to provide the growing number of people with goods and services; these people need them to survive or as a prerequisite for a "good" life. however, at the same time it must be kept in mind that these interventions often inflict irreversible damage on the environment and destroy possible future usage potentials for future generations. above and beyond this, for the human race, nature is a cradle of social, cultural, aesthetic and religious values, the infringement of which, in turn, has a major influence on people's well-being. on both sides of the equation, there are therefore important goods that have to be appreciated when interventions in nature occur. but what form should such an appreciation take? if the pros and cons of the intervention in nature have to be weighed against each other, criteria are needed that can be used as yardsticks. who can and may draw up such criteria, according to which standards should the interventions be assessed and how can the various evaluative options for action be compared with each other for each criterion? taking risks always involves two major components: an assessment of what we can expect from an intervention into the environment (be it the use of resources or the use of environments as a sink for our waste). this is the risk and benefit assessment side of the risk analysis. secondly, we need to decide whether the assessed consequences are desirable. whereas the estimate of consequences broadly falls in the domain of scientific research and expertise, with uncertainties and ambiguities in particular having to be taken into account (irgc , klinke and renn ) , the question about the foundations for evaluating various options for action and about drawing up standards guiding action is a central function of ethics (taylor ) . ethics can provide an answer to the question posed in the beginning ("should people be allowed to do everything that they are capable of doing?") in a consistent and transparent manner. in section . . , environmental ethics will be briefly introduced. this review is inspired by the need for a pragmatic and policy-oriented approach. it is not a replacement for a comprehensive and theoretically driven compendium of environmental ethics. environmental ethics will then be applied to evaluate environmental assets. in this process, a simple distinction is made between categorical principles -that must under no circumstances be exceeded or violated -and compensatory principles, where compensation with other competing principles is allowed. this distinction consequently leads to a classification of environmental values, which, in turn, can be broken down into criteria to appreciate options for designing environmental policies. in section . . , these ideas of valuation will be taken up and used to translate the value categories into risk handling guidelines. at the heart of the considerations here is the issue of how the aims of ethically founded considerations can be used to support and implement risk-based balancing of costs and benefits. for this purpose, we will develop an integrative risk governance framework. the concept of risk governance comprises a broad picture of risk: not only does it include what has been termed "risk management" or "risk analysis", it also looks at how risk-related decision making unfolds when a range of actors is involved, requiring co-ordination and possibly reconciliation between a profusion of roles, perspectives, goals and activities. indeed, the problem-solving capacities of individual actors, be they government, the scientific community, business players, ngos or civil society as a whole, are limited and often unequal to the major challenges facing society today. then the ideas of the operational implementation of normative and factual valuations are continued and a procedure is described that is capable of integrating ethical, risk-based and work-related criteria into a proposed procedural orientation. this procedure is heavily inspired by decision analysis. answering the question about the right action is the field of practical philosophy, ethics. following the usual view in philosophy, ethics describes the theory of the justification of normative statements, i.e. those that guide action (gethmann , mittelstraß , nida-rümelin a , revermann . a system of normative statements is called "morals". ethical judgements therefore refer to the justifiability of moral instructions for action that may vary from individual to individual and from culture to culture (ott ) . basically, humans are purpose-oriented and self-determined beings who act not only instinctively, but also with foresight, and are subject to the moral standards to carry out only those actions that they can classify as good and justifiable (honnefelder ) . obviously, not all people act according to the standards that they themselves see as necessary, but they are capable of doing so. in this context, it is possible for people to act morally because, on the one hand, they are capable of distinguishing between moral and immoral action and, on the other, are largely free to choose between different options for action. whether pursuing a particular instruction for action should be considered as moral or immoral is based on whether the action concerned can be felt and justified to be "reasonable" in a particular situation. standards that cross over situations and that demand universal applicability are referred to as principles here. conflicts may arise between competing standards (in a specific situation), as well as between competing principles, the solution of which, in turn, needs justification (szejnwald-brown et al. ) . providing yardsticks for such justification or examining moral systems with respect to their justifiability is one of the key tasks of practical ethics (gethmann ) . in ethics a distinction is made between descriptive (experienced morality) and prescriptive approaches, i.e. justifiable principles of individual and collective behaviour (frankena , hansen . all descriptive approaches are, generally speaking, a "stock-taking" of actually experienced standards. initially, it is irrelevant whether these standards are justified or not. they gain their normative force solely from the fact that they exist and instigate human action (normative force of actual action). most ethicists agree that no conclusions about general validity can be drawn from the actual existence of standards. this would be a naturalistic fallacy (akademie der wissenschaften , ott ) . nevertheless, experienced morality can be an important indicator of different, equally justifiable moral systems, especially where guidance for cross-cultural behaviour is concerned. this means that the actual behaviour of many people with regard to their natural environment reveals which elements of this environment they value in particular and which they do not. however, in this case, too, the validity of the standards is not derived from their factuality, but merely used as a heurism in order to find an adequate (possibly culture-immanent) justification. but given the variety of cultures and beliefs, how can standards be justified inter-subjectively, i.e. in a way that is equally valid to all? is it not the case that science can only prove or disprove factual statements (and this only to a certain extent), but not normative statements? a brief discourse on the various approaches in ethics is needed to answer this question. first of all, ethics is concerned with two different target aspects: on the one hand, it is concerned with the question of the "success" of one's own "good life", i.e. with the standards and principles that enable a person to have a happy and fulfilled life. this is called eudemonistic ethics. on the other hand, it is concerned with the standards and principles of living together, i.e. with binding regulations that create the conditions for a happy life: the common good. this is called normative ethics (galert , ott . within normative ethics a distinction is made between deontological and teleological approaches when justifying normative statements (höffe ) . deontological approaches are principles and standards of behaviour that apply to the behaviour itself on the basis of an external valuation criterion. it is not the consequences of an action that are the yardstick of the valuation; rather, it is adhering to inherent yardsticks that can be used against the action itself. such external yardsticks of valuation are derived from religion, nature, intuition or common sense, depending on the basic philosophical direction. thus, protection of the biosphere can be seen as a divine order to protect creation (rock , schmitz , as an innate tendency for the emotional attachment of people to an environment with biodiversity (wilson ) , as a directly understandable source of inspiration and joy (ehrenfeld ) or as an educational means of practising responsibility and maintaining social stability (gowdy ) . by contrast, teleological approaches refer to the consequences of action. here, too, external standards of valuation are needed since the ethical quality of the consequences of action also have to be evaluated against a yardstick of some kind. with the most utilitarian approaches (a subset of the teleological approaches) this yardstick is defined as an increase in individual or social benefit. in other schools of ethics, intuition (can the consequence still be desirable?) or the aspect of reciprocity (the so-called "golden rule": "do as you would be done by") play a key role. in the approaches based on logical reasoning (especially in kant), the yardstick is derived from the logic of the ability to generalize or universalize. kant himself is in the tradition of deontological approaches ("good will is not good as a result of what it does or achieves, but just as a result of the intention"). according to kant, every principle that, if followed generally, makes it impossible for a happy life to be conducted is ethically impermissible. in this connection, it is not the desirability of the consequences that captures kant's mind, but the logical inconsistency that results from the fact that the conditions of the actions of individuals would be undermined if everyone were to act according to the same maxims (höffe ) . a number of contemporary ethicists have taken up kant's generalization formula, but do not judge the maxims according to their internal contradictions; rather, they judge them according to the desirability of the consequences to be feared from the generalization (jonas or zimmerli should be mentioned here). these approaches can be defined as a middle course between deontological and teleological forms of justification. in addition to deontological and teleological approaches, there is also the simple solution of consensual ethics, which, however, comprises more than just actually experienced morality. consensual ethics presupposes the explicit agreement of the people involved in an action. everything is allowed provided that all affected (for whatever reason) voluntarily agree. in sexual ethics at the moment a change from deontological ethics to a consensual moral code can be seen. the three forms of normative ethics are shown in figure . . the comparison of the basic justification paths for normative moral systems already clearly shows that professional ethicists cannot create any standards or des- ignate any as clearly right, even if they play a role in people's actual lives. much rather it is the prime task of ethics to ensure on the basis of generally recognized principles (for example, human rights) that all associated standards and behaviour regulations do not contradict each other or a higher order principle. above and beyond this, ethics can identify possible solutions that may occur with a conflict between standards and principles of equal standing. ethics may also reveal interconnections of justification that have proved themselves as examination criteria for moral action in the course of their disciplinary history. finally, many ethicists see their task as providing methods and procedures primarily of an intellectual nature by means of which the compatibility or incompatibility of standards within the framework of one or more moral systems can be completed. unlike the law, the wealth of standards of ethics is not bound to codified rules that can be used as a basis for such compatibility examinations. every normative discussion therefore starts with the general issues that are needed in order to allow individuals a "good life" and, at the same time, to give validity to the principles required to regulate the community life built on common good. but how can generally binding and inter-subjectively valid criteria be made for the valuation of "the common good"? in modern pluralistic societies, it is increasingly difficult for individuals and groups of society to draw up or recognize collectively binding principles that are perceived by all equally as justifiable and as self-obliging (hartwich and wewer , zilleßen ) . the variety of lifestyle options and subjectiernization. with increasing technical and organizational means of shaping the future, the range of behaviour options available to people also expands. with the increasing plurality of lifestyles, group-specific rationalities emerge that create their own worldviews and moral standards, which demand a binding nature and validity only within a social group or subculture. the fewer cross-society guiding principles or behaviour orientations are available, the more difficult is the process of agreement on collectively binding orientations for action. however, these are vital for the maintenance of economic cooperation, for the protection of the natural foundations of life and for the maintenance of cohesion in a society. no society can exist without the binding specification of minimum canons of principles and standards. but how can agreement be reached on such collectively binding principles and standards? what criteria can be used to judge standards? the answers to this question depend on whether the primary principles, in other words, the starting point of all moral systems, or secondary principles or standards, i.e. follow-on standards that can be derived from the primary principles, are subjected to an ethical examination. primary principles can be categorical or compensatory (capable of being compensated). categorical principles are those that must not be infringed under any circumstances, even if other prin- fication of meaning (individualization) are accompanying features of mod-ciples would be infringed as a result. the human right to the integrity of life could be named here as an example. compensatory principles are those where temporary or partial infringement is acceptable, provided that as a result the infringement of a principle of equal or higher ranking is avoided or can be avoided. in this way certain freedom rights can be restricted in times of emergency. in the literature on ethical rules, one can find more complex and sophisticated classifications of normative rules. for our purpose to provide a simple and pragmatic framework, the distinction in four categories (principles and standards; categorical and compensatory) may suffice. this distinction has been developed from a decision-analytical perspective. but how can primary principles be justified as equally valid for all people? although many philosophers have made proposals here, there is a broad consensus today that neither philosophy nor any other human facility is capable of stating binding metacriteria without any doubt and for all people, according to which such primary principles should be derived or examined (mittelstraß ) . a final justification of normative judgements cannot be achieved by logical means either, since all attempts of this kind automatically end either in a logical circle, in an unending regression (vicious cycle) or in a termination of the procedure and none of these alternatives is a satisfactory solution for final justification (albert ). the problem of not being able to derive finally valid principles definitively, however, seems to be less serious than would appear at first glance. because, regardless of whether the basic axioms of moral rules are taken from intuition, observations of nature, religion, tradition reasoning or common sense, they have broadly similar contents. thus, there is broad consensus that each human individual has a right to life, that human freedom is a high-value good and that social justice should be aimed at. but there are obviously many different opinions about what these principles mean in detail and how they should be implemented. in spite of this plurality, however, discerning and well-intentioned observers can usually quickly agree, whether one of the basic principles has clearly been infringed. it is more difficult to decide whether they have clearly been fulfilled or whether the behaviour to be judged should clearly be assigned to one or several principles. since there is no finally binding body in a secular society that can specify primary principles or standards ex cathedra, in this case consensus among equally defendable standards or principles can be used (or pragmatically under certain conditions also majority decisions). ethical considerations are still useful in this case as they allow the test of generalization and the enhancement of awareness raising capabilities. in particular, they help to reveal the implications of such primary principles and standards. provided that primary principles are not concerned (such as human rights), the ethical discussion largely consists of examining the compatibility of each of the available standards and options for action with the primary principles. in this connection, the main concerns are a lack of contradictions (consistency), logical consistency (deductive validity), coherence (agreement with other principles that have been recognized as correct) and other, broadly logical criteria (gethmann ) . as the result of such an examination it is entirely possible to reach completely different conclusions that all correspond to the laws of logic and thus justify new plurality. in order to reach binding statements or valuations here the evaluator can either conduct a discussion in his "mind" and let the arguments for various standards compete with each other (rather like a platonic dialogue) or conduct a real discussion with the people affected by the action. in both cases the main concern is to use the consensually agreed primary principles to derive secondary principles of general action and standards of specific action that should be preferred over alternatives that can be equally justified. a plurality of solutions should be expected especially because most of the concrete options for action comprise only a gradual fulfilment and infringement of primary principles and therefore also include conflicting values. for value conflicts at the same level of abstraction there are, by definition, no clear rules for solution. there are therefore frequently conflicts between conserving life through economic development and destroying life through environmental damage. since the principle of conserving life can be used for both options a conflict is unavoidable in this case. to solve the conflicts, ethical considerations, such as the avoidance of extremes, staggering priorities over time or the search for third solutions can help without, however, being able to convincingly solve this conflict in principle to the same degree for all (szejnwald-brown et al. ) . these considerations lead to some important conclusions for the matter of the application of ethical principles to the issue of human action with regard to the natural environment. first of all, it contradicts the way ethics sees itself to develop ethics of its own for different action contexts. just as there can be no different rules for the logic of deduction and induction in nomological science, depending on which object is concerned, it does not make any sense to postulate an independent set of ethics for the environment (galert ) . justifications for principles and moral systems have to satisfy universal validity (nida-rümelin b). furthermore, it is not very helpful to call for a special moral system for the environment since this -like every other moral system -has to be traceable to primary principles. instead, it makes sense to specify the generally valid principles that are also relevant with regard to the issue of how to deal with the natural environment. at the same time standards should be specified that are appropriate to environmental goods and that reflect those principles that are valid beyond their application to the environment. as implied above, it does not make much sense to talk about an independent set of environmental ethics. much rather, general ethics should be transferred to issues relating to the use of the environment (hargrove ) . three areas are usually dealt with within the context of environmental ethics (galert ): • environmental protection, i.e. the avoidance or alleviation of direct or indirect, current or future damage and pollution resulting from anthropogenic emissions, waste or changes to the landscape, including land use, as well as the long-term securing of the natural foundations of life for people and other living creatures (birnbacher a ). • animal protection, i.e. the search for reasonable and enforceable standards to avoid or reduce pain and suffering in sentient beings (krebs , vischer ). • nature conservation, i.e. the protection of nature against the transforming intervention of human use, especially all measures to conserve, care for, promote and recreate components of nature deemed to be valuable, including species of flora and fauna, biotic communities, landscapes and the foundations of life required there (birnbacher a) . regardless which of these three areas are addressed we need to explore which primary principles be applied to them. when dealing with the environment, the traditional basic and human rights, as well as the civil rights that have been derived from them, should be just as much a foundation of the consideration as other areas of application in ethics. however, with regard to the primary principles there is a special transfer problem when addressing human interventions into nature and the environment: does the basic postulate of conservation of life apply only to human beings, to all other creatures or to all elements of nature, too? this question does not lead to a new primary principle, as one may suspect at first glance. much rather, it is concerned with the delineation of the universally recognized principle of the conservation of life that has already been specified in the basic rights canon. are only people included in this principle (this is the codified version valid in most legal constitutions today) or other living creatures, too? and if yes, which ones? should non-living elements be included as well? when answering this question, two at first sight contradictory positions can be derived: anthropocentrism and physiocentrism (taylor , ott , galert . the anthropocentric view places humans and their needs at the fore. nature's own original demands are alien to this view. interventions in nature are allowed if they are useful to human society. a duty to make provisions for the future and to conserve nature exists in the anthropocentric world only to the extent that natural systems are classed as valuable to people today and subsequent generations and that nature can be classed as a means and guarantor of human life and survival (norton , birnbacher b . in the physiocentric concept, which forms an opposite pole to the anthropocentric view, the needs of human beings are not placed above those of nature. here, every living creature, whether humans, animals or plants, have intrinsic rights with regard to the chance to develop their own lives within the framework of a natural order. merit for protection is justified in the physiocentric view by an inner value that is unique to each living creature or the environment in general. nature has a value of its own that does not depend on the functions that it fulfils today or may fulfil later from a human society's point of view (devall and sessions , callicott , rolston , meyer-abich . each of these prevailing understandings of the human-nature relationship has implications that are decisive for the form and extent of nature use by humans (elliot , krebs . strictly speaking, it could be concluded from the physiocentric idea that all human interventions in nature have to be stopped so that the rights of other creatures are not endangered. yet, not even extreme representatives of a physiocentric view would go so far as to reject all human interventions in nature because animals, too, change the environment by their ways of life (e.g. the elephant prevents the greening of the savannah). the central postulate of a physiocentric view is the gradual minimization of the depth of interventions in human use of nature. the only interventions that are permitted are those that contribute to directly securing human existence and do not change the fundamental composition of the surrounding natural environment. if these two criteria were taken to the extreme, neither population development beyond the boundaries of biological carrying capacity nor a transformation of natural land into pure agricultural land would be allowed. such a strict interpretation of physiocentrism would lead to a radical reversal of human history so far and is not compatible with the values and expectations of most people. the same is true for the unlimited transfer of anthropocentrism to dealings with nature. in this view, the use of natural services is subjected solely to the individual cost-benefit calculation. this can lead to unscrupulous exploitation of nature by humans with the aim of expanding human civilization. both extremes quickly lead to counter-intuitive implications. when the issue of environmental design and policy is concerned, anthropocentric and physiocentric approaches in their pure form are found only rarely, much rather they occur in different mixtures and slants. the transitions between the concepts are fluid. moderate approaches certainly take on elements from the opposite position. it can thus be in line with a fundamentally physiocentric perspective if the priority of human interests is not questioned in the use of natural resources. it is also true that the conclusions of a moderate form of anthropocentrism can approach the implications of the physiocentric view. table . provides an overview of various types of anthropocentric and physiocentric perspectives. if we look at the behaviour patterns of people in different cultures, physiocentric or anthropocentric basic positions are rarely maintained consistently (bargatzky and kuschel ; on the convergence theory: birnbacher ) . in the strongly anthropocentric countries in the west, people spend more money on the welfare and health of their own pets than on saving human lives in other countries. in the countries of the far east that are characterized by physiocentrism, nature is frequently exploited even more radically than in the industrialized countries of the west. this inconsistent action is not a justification for one view or the other, it is just a warning for caution when laying down further rules for use so that no extreme -and thus untenable -demands be made. also from an ethical point of view, radical anthropocentrism should be rejected just as much as radical physiocentrism. if, to take up just one argument, the right to human integrity is largely justified by the fact that causing pain by others should be seen as something to avoid, this consideration without a doubt has to be applied to other creatures that are also capable of feeling pain (referred to as: pathocentrism). here, therefore, pure anthropocentrism cannot convince. in turn, with a purely physiocentric approach the primary principles of freedom, equality and human dignity could not be maintained at all if every part of living nature were equally entitled to use the natural environment. under these circumstances people would have to do without agriculture, the conversion of natural land into agricultural land and breeding farm animals and pets in line with human needs. as soon table . different perspectives on nature. adapted from renn and goble ( : ). as physiocentrism is related to species and not to individuals as is done in some biocentric perspectives human priority is automatically implied; because where human beings are concerned, nearly all schools of ethics share the fundamental moral principle of an individual right to life from birth. if this right is not granted to individual animals or plants, a superiority of the human race is implicitly assumed. moderate versions of physiocentrism acknowledge a gradual de-escalation with respect to the claim of individual table . different perspectives on nature (continued). adapted from renn and goble ( : ). life protection. the extreme forms of both physiocentrism and anthropocentrism are therefore not very convincing and are hardly capable of achieving a global consensus. this means that only moderate anthropocentrism or moderate biocentrism should be considered. the image of nature that is used as a basis for the considerations in this section emphasizes the uniqueness of human beings vis-à-vis physiocentric views, but does not imply carte blanche for wasteful and careless dealings with nature. this moderate concept derives society's duty to conserve nature -also for future generations -from the life-preserving and life-enhancing meaning of nature for society. this is not just concerned with the instrumental value of nature as a "store of resources", it is also a matter of the function of nature as a provider of inspiration, spiritual experience, beauty and peace (birnbacher and schicha ) . in this context it is important that human beings -as the addressees of the moral standard -do not regard nature merely as material and as a way towards their own self-realization, but can also assume responsibility for conservation of their cultural and so-cial function, as well as their existential value above and beyond the objective and technically available benefits (honnefelder ) . one of the first people to express this responsibility of human stewardship of nature in an almost poetic way was the american ecologist aldo leopold, who pointed out people's special responsibility for the existence of nature and land as early as the s with the essay "the conservation ethics". his most well-known work "a sand county almanac" is sustained by the attempt to observe and assess human activities from the viewpoint of the land (a mountain or an animal). this perspective was clearly physiocentric and revealed fundamental insights about the relationship between humans and nature on the basis of empathy and shifting perspectives. his point of view had a strong influence on american environmental ethics and the stance of conservationists. although this physiocentric perspective raises many concerns, the idea of stewardship has been one of the guiding ideas for the arguments used in this section (pickett et al. ) . we are morally required to exercise a sort of stewardship over living nature, because nature cannot claim any rights for itself, but nevertheless has exceptional value that is important to man above and beyond its economic utility value (hösle ) . since contemporary society and the generations to come certainly use, or will use, more natural resources than would be compatible with a lifestyle in harmony with the given natural conditions, the conversion of natural land into anthropogenically determined agricultural land cannot be avoided (mohr ) . many people criticized human interventions into natural cycles as infringements of the applicable moral standards of nature conservation (for example, fastened onto the postulate of sustainability). but we should avoid premature conclusions here, as can be seen with the example of species protection. for example, where natural objects or phenomena are concerned that turn out to be a risk to human or non-human living creatures, the general call for nature conservation is already thrown into doubt (gale and cordray ) . not many people would call the eradication of cholera bacteria, hiv viruses and other pathogens morally bad (mittelstraß ) if remaining samples were kept under lock and key in laboratories. also, combating highly evolved creatures, such as cockroaches or rats meets with broad support if we ignore the call for the complete eradication of these species for the time being. an environmental initiative to save cockroaches would not be likely to gain supporters. if we look at the situation carefully, the valuation of human behaviour in these examples results from a conflict. because the conservation of the species competes with the objective of maintaining human health or the objective of a hygienic place to live, two principles, possibly of equal ranking, come face to face. in this case the options for action, which may all involve a gradual infringement of one or more principles, would have to be weighed up against each other. a general ban on eradicating a species can thus not be justified ethically, in the sense of a categorical principle, unless the maintenance of human health were to be given lower priority than the conservation of a species. with regard to the issue of species conservation, therefore, different goods have to be weighed up against each other. nature itself cannot show society what it is essential to conserve and how much nature can be traded for valuable commodities. humans alone are responsible for a decision and the resulting conflicts between competing objectives. appreciation and negotiation processes are therefore the core of the considerations about the ethical justification of rules for interventions. but this does not mean that there is no room for categorical judgements along the lines of "this or that absolutely must be prohibited" in the matter of human interventions into the natural environment. it follows on from the basic principle of conserving human life that all human interventions that threaten the ability of the human race as a whole, or a significant number of individuals alive today or in the future, to exist should be categorically prohibited. this refers to intervention threats to the systemic functions of the biosphere. such threats are one of the guiding principles that must not be exceeded under any circumstances, even if this excess were to be associated with high benefits. in the language of ethics this is a categorical principle, in the language of economics a good that is not capable of being traded. the "club" of categorical prohibitions should, however, be used very sparingly because plausible trade-offs can be thought up for most principles, the partial exceeding of which appears intuitively. in the case of threats to existence, however, the categorical rejection of the behaviour that leads to this is obvious. but what does the adoption of categorical principles specifically mean for the political moulding of environmental protection? in the past, a number of authors have tried to specify the minimum requirements for an ethically responsible moral system with respect to biosphere use. these so-called "safe minimum standards" specify thresholds for the open-ended measurement scale of the consequences of human interventions that may not be ex-ceeded even if there is a prospect of great benefits (randall , randall and farmer ) . in order to be able to specify these thresholds in more detail the breakdown into three levels proposed by the german scientific council for global environmental change is helpful (wbgu ) . these levels are: • the global bio-geochemical cycles in which the biosphere is involved as one of the causes, modulator or "beneficiary"; • the diversity of ecosystems and landscapes that have key functions as bearers of diversity in the biosphere; and • the genetic diversity and the species diversity that are both "the modelling clay of evolution" and basic elements of ecosystem functions and dynamics. where the first level is concerned, in which the functioning of the global ecosystem is at stake, categorical principles are obviously necessary and sensible, provided that no one wants to shake the primary principle of the permanent preservation of the human race. accordingly, all interventions in which important substance or energy cycles are significantly influenced at a global level and where globally effective negative impacts are to be expected are categorically prohibited. usually no stringently causal evidence of the harmful nature of globally relevant information is needed; justified suspicion of such harmfulness should suffice. later in this chapter we will make a proposal for risk valuation and management how the problem of uncertainty in the event of possible catastrophic damage potential should be dealt with (risk type cassandra). on the second level, the protection of ecosystems and landscapes, it is much more difficult to draw up categorical rules. initially, it is obvious that all interventions in landscapes in which the global functions mentioned on the first level are endangered must be avoided. above and beyond this, it is wise from a precautionary point of view to maintain as much ecosystem diversity as possible in order to keep the degree of vulnerability to the unforeseen or even unforeseeable consequences of anthropogenic and nonanthropogenic interventions as low as possible. even though it is difficult to derive findings for human behaviour from observations of evolution, the empirically proven statement "he who places everything on one card, always loses in the long run" seems to demonstrate a universally valid insight into the functioning of systemically organized interactions. for this reason, the conservation of the natural diversity of ecosystems and landscape forms is a categorical principle, whereas the depth of intervention allowed should be specified on the basis of principles and standards capable of compensation. the same can be said for the third level, genetic and species protection. here too, initially the causal chain should be laid down: species conservation, landscape conservation, maintaining global functions. wherever this chain is unbroken, a categorical order of conservation should apply. these species could be termed primary key species. this includes such species that are not only essential for the specific landscape type in which they occur, but also for the global cycles above and beyond this specific landscape type thanks to their special position in the ecosystem. probably, it will not be possible to organize all species under this functional contribution to the surrounding ecosystem, but we could also think of groups of species, for example, humus-forming bacteria. in second place there are the species that characterize certain ecosystems or landscapes. here they are referred to as secondary key species. they, too, are under special protection that is not necessarily under categorical reservations. their function value, however, is worthy of special attention. below these two types of species there are the remaining species that perform ecosystem functions to a greater or lesser extent. what this means for the worthiness for protection of these species and the point at which the precise limit for permitted intervention should be drawn, is a question that can no longer be solved with categorical principles and standards, but with the help of compensatory principles and standards. generally, here, too, as with the issue of ecosystem and landscape protection, the conservation of diversity as a strategy of "reinsurance" against ignorance, global risks and unforeseeable surprises is recommended. it remains to be said that from a systemic point of view, a categorical ban has to apply to all human interventions where global closed loops are demonstrably at risk. above and beyond this, it makes sense to recognize the conservation of landscape variety (also of ecosystem diversity within landscapes) and of genetic variety and species diversity as basic principles, without being able to make categorical judgements about individual landscape or species types as a result. in order to evaluate partial infringements of compensatory principles or standards, which are referred to in the issue of environmental protection, we need rules for decision making that facilitate the balancing process necessary to resolve compensatory conflicts. in the current debate about rules for using the environment and nature, it is mainly teleological valuation methods that are proposed (hubig , ott . these methods are aimed at: • estimating the possible consequences of various options for action at all dimensions relevant to potentially affected people; • recording the infringements or fulfilments of these expected consequences in the light of the guiding standards and principles; and • then weighing them according to an internal key so that they can be weighed up in a balanced way. on the positive side of the equation, there are the economic benefits of an intervention and the cultural values created by use, for example, in the form of income, subsistence (self-sufficiency) or an aesthetically attractive landscape (parks, ornamental gardens, etc.); on the negative side, there are the destruction of current or future usage potentials, the loss of unknown natural resources that may be needed in the future and the violation of aesthetic, cultural or religious attributes associated with the environment and nature. there are therefore related categories on both sides of the equation: current uses vs. possible uses in the future, development potentials of current uses vs. option values for future use, shaping the environment by use vs. impairments to the environment as a result of alternative use, etc. with the same or similar categories on the credit and debit side of the balance sheet the decision is easy when there is one option that performs better or worse than all the other options for all categories. although such a dominant (the best for all categories) or sub-dominant option (the worst for all categories) is rare in reality, there are examples of dominant or sub-dominant solutions. thus, for example, the overfelling of the forests of kalimantan on the island of borneo in indonesia can be classed as a sub-dominant option since the short-term benefit, even with extremely high discount rates, is in no proportion to the long-term losses of benefits associated with a barren area covered in imperata grass. the recultivation of a barren area of this kind requires sums many times the income from the sale of the wood, including interest. apparently there are no cultural, aesthetic or religious reasons for conversion of primary or secondary woodland into grassland. this means that the option of deforestation should be classed as of less value than alternative options for all criteria, including economic and social criteria. at best, we can talk about a habit of leaving rainforests, as a "biotope not worthy of conservation", to short-term use. but habit is not a sound reason for the choice of any sub-optimum option. as mentioned at the start of this chapter, habit as experienced morality, does not have any normative force, especially when this is based on the illusion of the marginality of one's own behaviour or ignorance about sustainable usage forms. but if we disregard the dominant or sub-dominant solutions, an appreciation between options that violate or fulfil compensatory standards and principles depends on two preconditions: best possible knowledge of the consequences (what happens if i choose option a instead of option b?) and a transparent, consistent rationale for weighing up these consequences as part of a legitimate political decision process (are the foreseeable consequences of option a more desirable or bearable than the consequences of option b?) (akademie der wissenschaften ). adequate knowledge of the consequences is needed in order to reveal the systemic connections between resource use, ecosystem reactions to human interventions and socio-cultural condition factors (wolters ) . this requires interdisciplinary research and cooperation. the task of applied ecological research, for example, is to show the consequences of human intervention in the natural environment and how ecosystems are burdened by different interventions and practices. the economic approach provides a benefit-oriented valuation of natural and artificial resources within the context of production and consumption, as well as a valuation of transformation processes according to the criterion of efficiency. cultural and social sciences examine the feedback effects between use, social development and cultural self-perception. they illustrate the dynamic interactions between usage forms, socio-cultural lifestyles and control forms. interdisciplinary, problem-oriented and system-related research contribute to forming a basic stock of findings and insights about functional links in the relationship between human interventions and the environment and also in developing constructive proposals as to how the basic question of an ethically justified use of the natural environment can be answered in agreement with the actors concerned (wbgu ) . accordingly, in order to ensure sufficient environmental protection, scientific research, but especially transdisciplinary system research at the interface between natural sciences and social sciences is essential. bringing together the results of interdisciplinary research, the policy-relevant choice of knowledge banks and balanced interpretation in an environment of uncertainty and ambivalence are difficult tasks that primarily have to be performed by the science system itself. how this can happen in a way that is methodslogically sound, receptive to all reasonable aspects of interpretation and yet subjectively valid will be the subject of section . . . but knowledge alone does not suffice. in order to be able to act effectively and efficiently while observing ethical principles, it is necessary to shape the appreciation process between the various options for action according to rational criteria (gethmann ) . to do this it is, first of all, necessary to identify the dimensions that should be used for a valuation. the discussion about the value dimensions to be used as a basis for valuation is one of the most popular subjects within environmental ethics. to apply these criteria in risk evaluation and to combine the knowledge aspects about expected consequences of different behavioural options with the ethical principles is the task of what we have called risk governance. what contribution do ethics make towards clarifying the prospects and limits of human interventions into the natural environment? the use of environmental resources is an anthropological necessity. human consciousness works reflexively and humans have developed a causal recognition capacity that enables them to record cause and effect anticipatively and to productively incorporate assessed consequences in their own action. this knowledge is the motivating force behind the cultural evolution and the development of technologies, agriculture and urbanization. with power over an ever-increasing potential of design and intervention in nature and social affairs over the course of human history, the potential for abuse and exploitation has also grown. whereas this potential was reflected in philosophical considerations and legal standards at a very early stage with regard to moral standards between people, the issue of human responsibility towards nature and the environment has only become the subject of intensive considerations in recent times. ethical considerations are paramount in this respect. on the one hand, they offer concrete standards for human conduct on the bases of criteria that can be generalized, and, on the other hand, they provide procedural advice about a rational and decision-and policy-making process. a simple breakdown into categorical rules and prohibitions that are capable of being compensated can assist decision makers for the justification of principles and standards on environmental protection. as soon as human activities exceed the guidelines of the categorical principles, there is an urgent need for action. how can we detect whether such an excess has happened and how it can be prevented from the very outset that these inviolable standards and principles be exceeded? here are three strategies of environmental protection to be helpful for the implementation of categor-ical guidelines. the first strategy is that of complete protection with severe restrictions of all use by humans (protection priority). the second strategy provides for a balanced relationship between protection and use, where extensive resource use should go hand in hand with the conservation of the ecosystems concerned (equal weight). the third strategy is based on optimum use involving assurance of continuous reproduction. the guiding principle here would be an intensive and, at the same time, sustainable, i.e. with a view to the long term, use of natural resources (use priority). the following section will present a framework for applying these principles into environmental decision making under risk. the main line of argument is that risk management requires an analytic-deliberative approach for dealing effectively and prudently with environmental risks. assessing potential consequences of human interventions and evaluating their desirability on the basis of subsequent knowledge and transparent valuation criteria are two of the central tasks of a risk governance process. however, the plural values of a heterogeneous public and people's preferences have to be incorporated in this process. but how can this be done given the wealth of competing values and preferences? should we simply accept the results of opinion polls as the basis for making political decisions? can we rely on risk perception results to judge the seriousness of pending risks? or should we place all our faith in professional risk management? if we turn to professional help to deal with plural value input, economic theory might provide us an answer to this problem. if environmental goods are made individual and suitable for the market by means of property rights, the price that forms on the market ensures an appropriate valuation of the environmental good. every user of this good can then weigh up whether he is willing to pay the price or would rather not use the good. with many environmental goods, however, this valuation has to be made by collective action, because the environmental good concerned is a collective or open access good. in this case a process is needed that safeguards the valuation and justifies it to the collective. however, this valuation cannot be determined with the help of survey results. although surveys are needed to be able to estimate the breadth of preferences and people's willingness to pay, they are insufficient for a derivation of concrete decision-making criteria and yardsticks for evaluating the tolerability of risks to human health and the environment. • firstly, the individual values are so widely scattered that there is little sense in finding an average value here. • secondly, the preferences expressed in surveys change much within a short time, whereas ethical valuations have to be valid for a long time. • thirdly, as outlined in the subsection on risk perception, preferences are frequently based on flawed knowledge or ad hoc assumptions both of which should not be decisive according to rational considerations. what is needed, therefore, is a gradual process of assigning trade-offs in which existing empirical values are put into a coherent and logically consistent form. in political science and sociological literature reference is mostly made to three strategies of incorporating social values and preferences in rational decision-making processes (renn ) . firstly, a reference to social preferences is viewed solely as a question of legitimate procedure (luhmann , vollmer . the decision is made on the basis of formal decision-making process (such as majority voting). if all the rules have been kept, a decision is binding, regardless of whether the subject matter of the decision can be justified or whether the people affected by the decision can understand the justification. in this version, social consensus has to be found only about the structure of the procedures; the only people who are then involved in the decisions are those who are explicitly legitimated to do so within the framework of the procedure decided upon. the second strategy is to rely on the minimum consensuses that have developed in the political opinion-forming process (muddling through) (lindbloom (lindbloom , . in this process, only those decisions that cause the least resistance in society are considered to be legitimate. in this version of social pluralism groups in society have an influence on the process of the formation of will and decision making to the extent that they provide proposals capable of being absorbed, i.e. adapted to the processing style of the political system, and that they mobilize public pressure. the proposal that then establishes itself in politics is the one that stands up best in the competition of proposals, i.e. the one that entails the fewest losses of support for political decision makers by interest groups. the third strategy is based on the discussion between the groups involved (habermas , renn ). in the communicative exchange among the people involved in the discussion a form of communicative rationality that everyone can understand evolves that can serve as a justification for collectively binding decisions. at the same time, discursive methods claim to more appropriately reflect the holistic nature of human beings and also to provide fair access to designing and selecting solutions to problems. in principle, the justification of standards relevant to decisions is linked to two conditions: the agreement of all involved and substantial justification of the statements made in the discussion (habermas ) . all three strategies of political control are represented in modern societies to a different extent. legitimation conflicts mostly arise when the three versions are realized in their pure form. merely formally adhering to decisionmaking procedures without a justification of content encounters a lack of understanding and rejection among the groups affected especially when they have to endure negative side effects or risks. then acceptance is refused. if, however, we pursue the opposite path of least resistance and base ourselves on the route of muddling through we may be certain of the support of the influential groups, but, as in the first case, the disadvantaged groups will gradually withdraw their acceptance because of insufficient justification of the decision. at the same time, antipathy to politics without a line or guidance is growing, even the affected population. the consequence is political apathy. the third strategy of discursive control faces problems, too. although in an ideal situation it is suitable for providing transparent justifications for the decision-making methods and the decision itself, in real cases the conditions of ideal discourse can rarely be adhered to (wellmer ) . frequently, discussions among strategically operating players lead to a paralysis of practical politics by forcing endless marathon meetings with vast quantities of points of order and peripheral contributions to the discussion. the "dictatorship of patience" (weinrich ) ultimately determines which justifications are accepted by the participants. the public becomes uncertain and disappointed by such discussions that begin with major claims and end with trivial findings. in brief: none of the three ways out of the control dilemma can convince on its own; as so often in politics, everything depends on the right mixture. what should a mixture of the three elements (due process, pluralistic muddling through and discourse) look like so that a maximum degree of rationality can come about on the basis of social value priorities? a report by the american academy of sciences on the subject of "understanding environmental risks" (national research council ) comes to the conclusion that scientifically valid and ethically justified procedure for the collective valuation of options for risk handling can only be realized within the context of -what the authors coin -an analytic-deliberative process. analytic means that the best scientific findings about the possible consequences and conditions of collective action are incorporated in the negotiations; deliberative means that rationally and ethically transparent criteria for making trade-offs are used and documented externally. moreover, the authors consider that fair participation by all groups concerned is necessary to ensure that the different moral systems that can legitimately exist alongside each other should also be incorporated in the process. to illustrate the concept of analytic-deliberative decision making consider a set of alternative options or choices, from which follow consequences (see basic overview in dodgson et al. ) . the relationship between the choice made, and the consequences that follow from this choice, may be straightforward or complex. the science supporting environmental policy is often complicated, across many disciplines of science and engineering, and also involving human institutions and economic interactions. because of limitations in scientific understanding and predictive capabilities, the consequences following a choice are normally uncertain. finally, different individuals and groups within society may not agree on how to evaluate the consequences -which may involve a detailed characterization of what happens in ecological, economic, and human health terms. we shall describe consequences as ambiguous when there is this difficulty in getting agreement on how to interpret and evaluate them. this distinction has been further explained in chapter (see also klinke and renn ) . environmental assessment and environmental decision making inherently involve these difficulties of complexity, uncertainty, and ambiguity (klinke and renn ) . in some situations where there is lots of experience, these difficulties may be minimal. but in other situations these difficulties may constitute major impediments to the decision-making process. to understand how analysis and deliberation interact in an iterative process following the national research council (nrc) report, one must consider how these three areas of potential difficulty can be addressed. it is useful to separate questions of evidence with respect to the likelihood, magnitude of consequences and related characteristics (which can involve complexity and uncertainty) from valuation of the consequences (i.e. ambiguity). for each of the three areas there are analytical tools that can be helpful in identifying, characterizing and quantifying cause-effect relationships. some of these tools have been described in chapter . the integration of these tools of risk governance into a consistent procedure will be discussed in the next subsections. the possibility to reach closure on evaluating risks to human health or the environment rests on two conditions: first, all participants need to achieve closure on the underlying goal (often legally prescribed, such as prevention of health detriments or guarantee of an undisturbed environmental quality, for example, purity laws for drinking water); secondly, they need to agree with the implications derived from the present state of knowledge (whether and to what degree the identified hazard impacts the desired goal). dissent can result from conflicting values as well as conflicting evidence. it is crucial in environmental risk management to investigate both sides of the coin: the values that govern the selection of the goal and the evidence that governs the selection of cause-effect claims. strong differences in both areas can be expected in most environmental decision-making contexts but also in occupational health and safety and public health risks. so for all risk areas it is necessary to explore why people disagree about what to do -that is, which decision alternative should be selected. as pointed out before, differences of opinion may be focused on the evidence of what is at stake or which option has what kind of consequences. for example: what is the evidence that an environmental management initiative will lead to an improvement, such as reducing losses of agricultural crops to insect pests -and what is the evidence that the management initiative could lead to ecological damage -loss of insects we value, such as bees or butterflies, damage to birds and other predators that feed on insects -and health impacts from the level of pesticides and important nutrients in the food crops we eat? other differences of opinion may be about values -value of food crops that contain less pesticide residue compared to those that contain more, value of having more bees or butterflies, value of maintaining indigenous species of bees or butterflies compared to other varieties not native to the local ecosystem, value ascribed to good health and nutrition, and maybe, value ascribed to having food in what is perceived to be a "natural" state as opposed to containing manufactured chemical pesticides or altered genetic material. separating the science issues of what will happen from the value issues of how to make appropriate trade-offs between ecological, economic, and human health goals can become very difficult. the separation of facts and values in decision making is difficult to accomplish in practical decision situations, since what is regarded as facts includes a preference dependent process of cognitive framing (tversky and kahneman ) and what is regarded as value includes a prior knowledge about the factual implica-tions of different value preferences (fischhoff ) . furthermore, there are serious objections against a clear-cut division from a sociological view on science and knowledge generation (jasanoff ) . particularly when calculating risk estimates, value-based conventions may enter the assessment process. for example, conservative assumptions may be built into the assessment process, so that some adverse effects (such as human cancer from pesticide exposure) are much less likely to be underestimated than overestimated (national research council ) . at the same time, ignoring major sources of uncertainty can evoke a sense of security and overconfidence that is not justified from the quality or extent of the data base (einhorn and hogarth ) . perceptions and world views may be very important, and difficult to sort out from matters of science, especially with large uncertainties about the causes of environmental damage. a combination of analytic and deliberative processes can help explore these differences of opinions relating to complexity, uncertainty, and ambiguity in order to examine the appropriate basis for a decision before the decision is made. most environmental agencies go through an environmental assessment process and provide opportunities for public review and comment. many controversial environmental decisions become the focus of large analytical efforts, in which mathematical models are used to predict the environmental, economic, and health consequences of environmental management alternatives. analysis should be seen as an indispensable complement to deliberative processes, regardless whether this analysis is sophisticated or not. even simple questions need analytic input for making prudent decisions, especially in situations where there is controversy arising from complexity, uncertainty, and ambiguity. in many policy arenas in which problems of structuring human decisions are relevant, the tools of normative decision analysis (da) have been applied. especially in economics, sociology, philosophical ethics, and also many branches of engineering and science, these methods have been extended and refined during the past several decades. (edwards , howard , north , howard et al. , north and merkhofer , behn and vaupel , pinkau and renn , van asselt , jaeger et al. . da is a process for decomposing a decision problem into pieces, starting with the simple structure of alternatives, information, and prefer-ences. it provides a formal framework for quantitative evaluation of alternative choices in terms of what is known about the consequences and how the consequences are valued (hammond et al. , skinner . the procedures and analytical tools of da provide a number of possibilities to improve the precision and transparency of the decision procedure. however, they are subject to a number of limitations. the opportunities refer to: • different action alternatives can be quantitatively evaluated to allow selection of a best choice. such evaluation relies both on a description of uncertain consequences for each action alternative, with uncertainty in the consequences described using probabilities, and a description of the values and preferences assigned to consequences. (explicit characterization of uncertainty and values of consequences) • the opportunity to assure transparency, in that ( ) models and data summarizing complexity (e.g., applicable and available scientific evidence) ( ) probabilities characterizing judgement about uncertainty, and ( ) values (utilities) on the consequences are made explicit and available. so the evaluation of risk handling alternatives can be viewed and checked for accuracy by outside observers. (outside audit enabled of basis for decision) • a complex decision situation can be decomposed into smaller pieces in a formal analytical framework. the level of such composition can range from a decision tree of action alternatives and ensuing consequences that fits on a single piece of paper, to extremely large and complex computerimplemented models used in calculating environmental consequences and ascribing probabilities and values of the consequences. a more complex analysis is more expensive and is less transparent to observers. in principle, with sufficient effort any formal analytical framework can be checked to assure that calculations are made in the way that is intended. (decomposition possible to include extensive detail) on the other hand, there are important limitations: • placing value judgements (utilities) on consequences may be difficult, especially in a political context where loss of life, impairment of health, ecological damage, or similar social consequences are involved. utility theory is essentially an extension of cost-benefit methods from economics to include attitude toward risk. the basic trade-off judgements needed for cost-benefit analysis remain difficult and controversial, and often, inherently subjective. (difficulties in valuing consequences) • assessing uncertainty in the form of a numerical probability also poses difficulties, especially in situations when there is not a statistical data base on an agreed-on model as the basis for the assessment. (difficulty in quantifying uncertainty, assigning probabilities) • the analytical framework may not be complete. holistic or overarching considerations or important details may have been omitted. (analytical framework incomplete) • da is built upon an axiomatic structure, both for dealing with uncertainty (i.e., the axiomatic foundation of probability theory), and for valuing consequences (i.e., the axiomatic basis for von neumann-morgenstern utility theory). especially when the decision is to be made by a group rather than an individual decision maker, rational preferences for the group consistent with the axioms may not exist (the "impossibility" theorem of arrow, ) . so in cases of strong disagreements on objectives or unwillingness to use a rational process, decision analysis methods may not be helpful. decision analytical methods should not be regarded as inherently "mechanical" or "algorithmic", in which analysts obtain a set of "inputs" about uncertainty and valuing consequences, then feed these into a mathematical procedure (possibly implemented in a computer) that produces an "output" of the "best" decision. da can only offer coherent conclusions from the information which the decision maker provides by his/her preferences among consequences and his/her state of information on the occurrence of these consequences. where there is disagreement about the preferences or about the information, da may be used to implore the implications of such disagreement. so in application, there is often a great deal of iteration (sensitivity analysis) to explore how differences in judgement should affect the selection of the best action alternative. da thus merely offers a formal framework that can be effective in helping participants in a decision process to better understand the implications of differing information and judgement about complex and uncertain consequences from the choice among the available action alternatives. insight about which factors are most important in selecting among the alternatives is often the most important output of the process, and it is obtained through extensive and iterative exchange between analysts and the decision makers and stakeholders. the main advantage of the framework is that it is based on logic that is both explicit and checkable -usually facilitated by the use of mathematical models and probability calculations. research on human judgement supports the superiority of such procedures for decomposing complex decision problems and using logic to integrate the pieces, rather than relying on holistic judgement on which of the alternatives is best (this is not only true for individual decisions, see heap et al. : ff., jungermann ; but also for collective decisions, see heap et al. : ff., pettit . one should keep in mind, however, that "superior" is measured in accordance with indicator of instrumental rationality, i.e. measuring means-ends effectiveness. if this rationality is appropriate, the sequence suggested by da is intrinsically plausible and obvious. even at the level of qualitative discussion and debate, groups often explore the rationale for different action alternatives. decision analysis simply uses formal quantitative methods for this traditional and common-sense process of exploring the rationale -using models to describe complexity, probability to describe uncertainty, and to deal with ambiguity, explicit valuation of consequences via utility theory and other balancing procedures, such as cost-benefit or cost-effectiveness analyses. by decomposing the problem in logical steps, the analysis permits better understanding of differences in the participants' perspective on evidence and values. da offers methods to overcome these differences, such as resolving questions about underlying science through data collection and research, and encouraging tradeoffs, compromise, and rethinking of values. based on this review of opportunities and shortcomings we conclude that decision analysis provides a suitable structure for guiding discussion and problem formulation, and offers a set of quantitative analytical tools that can be useful for environmental decisions, especially in conjunction with deliberative processes. da can assist decision makers and others involved in, and potentially affected by, the decision (i.e., participants, stakeholders) to deal with complexity and many components of uncertainty, and to address issues of remaining uncertainties and ambiguities. using these methods promises consistency from one decision situation to another, assurance of an appropriate use of evidence from scientific studies related to the environment, and explicit accountability and transparency with respect to those institutionally responsible for the value judgements that drive the evaluation of the alternative choices. collectively the analytical tools provide a framework for a systematic process of exploring and evaluating the decision alternatives -assembling and validating the applicable scientific evidence relevant to what will happen as the result of each possible choice, and valuing how bad or how good these consequences are based on an agreement of common objectives. yet, it does not replace the need for additional methods and processes for including other objectives, such as finding common goals, defining preferences, revisiting assumptions, sharing visions and exploring common grounds for values and normative positions. the value judgements motivating decisions are made explicit and can then be criticized by those who were not involved in the process. to the extent that uncertainty becomes important, it will be helpful to deal with uncertainty in an orderly and consistent way (morgan and henrion ). those aspects of uncertainty that can be modelled by using probability theory (inter-target variation, systematic and random errors in applying inferential statistics, model and data uncertainties) will be spelled out and those that remain in forms of indeterminacies, system boundaries or plain ignorance will become visible and can then be fed into the deliberation process (van asselt , klinke and renn ) . the term deliberation refers to the style and procedure of decision making without specifying which participants are invited to deliberate (national research council (nrc) , rossi ) . for a discussion to be called deliberative it is essential that it relies on mutual exchange of arguments and reflections rather than decision making based on the status of the participants, sublime strategies of persuasion, or social-political pressure. deliberative processes should include a debate about the relative weight of each argument and a transparent procedure for balancing pros and cons (tuler and webler ) . in addition, deliberative processes should be governed by the established rules of a rational discourse. in the theory of communicative action developed by the german philosopher jürgen habermas, the term discourse denotes a special form of a dialogue, in which all affected parties have equal rights and duties to present claims and test their validity in a context free of social or political domination (habermas (habermas , b . a discourse is called rational if it meets the following specific requirements (see mccarthy , habermas a , kemp , webler . all participants are obliged: • to seek a consensus on the procedure that they want to employ in order to derive the final decision or compromise, such as voting, sorting of positions, consensual decision making or the involvement of a mediator or arbitrator; • to articulate and criticize factual claims on the basis of the "state of the art" of scientific knowledge and other forms of problem-adequate knowledge; (in the case of dissent all relevant camps have the right to be represented); • to interpret factual evidence in accordance with the laws of formal logic and analytical reasoning; • to disclose their relevant values and preferences, thus avoiding hidden agendas and strategic game playing; and • to process data, arguments and evaluations in a structured format (for example a decision-analytic procedure) so that norms of procedural rationality are met and transparency can be created. the rules of deliberation do not necessarily include the demand for stakeholder or public involvement. deliberation can be organized in closed circles (such as conferences of catholic bishops, where the term has indeed been used since the council of nicosia), as well as in public forums. it may be wise to use the term "deliberative democracy" when one refers to the combination of deliberation and public or stakeholder involvement (see also cohen , rossi . what needs to be deliberated? firstly, deliberative processes are needed to define the role and relevance of systematic and anecdotal knowledge for making far-reaching choices. secondly, deliberation is needed to find the most appropriate way to deal with uncertainty in environmental decision making and to set efficient and fair trade-offs between potential over-and under-protection. thirdly, deliberation needs to address the wider concerns of the affected groups and the public at large. why can one expect that deliberative processes are better suited to deal with environmental challenges than using expert judgement, political majority votes or relying on public survey data? • deliberation can produce common understanding of the issues or the problems based on the joint learning experience of the participants with respect to systematic and anecdotal knowledge (webler and renn , pidgeon ). • deliberation can produce a common understanding of each party's position and argumentation and thus assist in a mental reconstruction of each actor's argumentation (warren , tuler . the main driver for gaining mutual understanding is empathy. the theory of communicative action provides further insights in how to mobilize empathy and how to use the mechanisms of empathy and normative reasoning to explore and generate common moral grounds (webler ). • deliberation can produce new options and novel solutions to a problem. this creative process can either be mobilized by finding win-win solutions or by discovering identical moral grounds on which new options can grow (renn ) . • deliberation has the potential to show and document the full scope of ambiguity associated with environmental problems. deliberation helps to make a society aware of the options, interpretations, and potential actions that are connected with the issue under investigation (wynne , de marchi and ravetz ) . each position within a deliberative discourse can only survive the crossfire of arguments and counter-arguments if it demonstrates internal consistency, compatibility with the legitimate range of knowledge claims and correspondence with the widely accepted norms and values of society. deliberation clarifies the problem, makes people aware of framing effects, and determines the limits of what could be called reasonable within the plurality of interpretations (skillington ) . • deliberations can also produce agreements. the minimal agreement may be a consensus about dissent (raiffa ) . if all arguments are exchanged, participants know why they disagree. they may not be convinced that the arguments of the other side are true or morally strong enough to change their own position; but they understand the reasons why the opponents came to their conclusion. in the end, the deliberative process produces several consistent and -in their own domain -optimized positions that can be offered as package options to legal decision makers or the public. once these options have been subjected to public discourse and debate, political bodies, such as agencies or parliaments can make the final selection in accordance with the legitimate rules and institutional arrangements such as majority vote or executive order. final selections could also be performed by popular vote or referendum. • deliberation may result in consensus. often deliberative processes are used synonymously with consensus-seeking activities (coglianese ). this is a major misunderstanding. consensus is a possible outcome of deliberation, but not a mandatory requirement. if all participants find a new option that they all value more than the one option that they preferred when entering the deliberation, a "true" consensus is reached (renn ) . it is clear that finding such a consensus is the exception rather than the rule. consensus is either based on a win-win solution or a solution that serves the "common good" and each participant's interests and values better than any other solution. less stringent is the requirement of a tolerated consensus. such a consensus rests on the recognition that the selected decision option might serve the "common good" best, but on the expense of some interest violations or additional costs. in a tolerated consensus some participants voluntarily accept personal or group-specific losses in exchange for providing benefits to all of society. case studies have provided sufficient evidence that deliberation has produced a tolerated consensus solution, particularly in siting conflicts (one example in schneider et al. ) . consensus and tolerated consensus should be distinguished from compromise. a compromise is a product of bargaining where each side gradually reduces its claim to the opposing party until they reach an agreement (raiffa ) . all parties involved would rather choose the option that they preferred before starting deliberations, but since they cannot find a win-win situation or a morally superior alternative they look for a solution that they can "live with" knowing that it is the second or third best solution for them. compromising on an issue relies on full representation of all vested interests. in summary, many desirable products and accomplishments are associated with deliberation (chess et al. ) . depending on the structure of the discourse and the underlying rationale deliberative processes can: • enhance understanding; • generate new options; • decrease hostility and aggressive attitudes among the participants; • explore new problem framing; • enlighten legal policy-makers; • produce competent, fair and optimized solution packages; and • facilitate consensus, tolerated consensus and compromise. in a deliberative setting, participants exchange arguments, provide evidence for their claims and develop common criteria for balancing pros and cons. this task can be facilitated and often guided by using decision analytic tools (overview in merkhofer ) . decision theory provides a logical framework distinguishing action alternatives or options, consequences, likelihood of consequences, and value of consequences, where the valuation can be over multiple attributes that are weighted based on tradeoffs in multi-attribute utility analysis (edwards ) . a sequence of decisions and consequences may be considered, and use of mathematical models for predicting the environmental consequences of options may or may not be part of the process (humphreys , bardach , arvai et al. ): a) the structuring potential of decision analysis has been used in many participatory processes. it helps the facilitator of such processes to focus on one element during the deliberation, to sort out the central from the peripheral elements, provide a consistent reference structure for ordering arguments and observations and to synthesize multiple impressions, observations and arguments into a coherent framework. the structuring power of decision analysis has often been used without expanding the analysis into quantitative modelling. b) the second potential, agenda setting and sequencing, is also frequently applied in participatory settings. it often makes sense to start with problem definition, then develop the criteria for evaluation, generate options, assess consequences of options, and so on. c) the third potential, quantifying consequences, probabilities and relative weights and calculating expected utilities, is more controversial than the other two. whether the deliberative process should include a numerical analysis of utilities or engage the participants in a quantitative elicitation process is contested among participation practitioners . one side claims that quantifying helps participants to be more precise about their judgements and to be aware of the often painful trade-offs they are forced to make. in addition, quantification can make judgements more transparent to outside observers. the other side claims that quantification restricts the participants to the logic of numbers and reduces the complexity of argumentation into a mere trade-off game. many philosophers argue that quantification supports the illusion that all values can be traded off against other values and that complex problems can be reduced to simple linear combinations of utilities. one possible compromise between the two camps may be to have participants go through the quantification exercise as a means to help them clarify their thoughts and preferences, but make the final decisions on the basis of holistic judgements (renn ) . in this application of decision analytic procedures, the numerical results (i.e. for each option the sum over the utilities of each dimension multiplied by the weight of each dimension) of the decision process are not used as expression of the final judgement of the participant, but as a structuring aid to improve the participant's holistic, intuitive judgement. by pointing out potential discrepancies between the numerical model and the holistic judgements, the participants are forced to reflect upon their opinions and search for potential hidden motives or values that might explain the discrepancy. in a situation of major value conflicts, the deliberation process may involve soliciting a diverse set of viewpoints, and judgements need to be made on what sources of information are viewed as responsible and reliable. publication in scientific journals and peer review from scientists outside the government agency are the two most popular methods by which managers or organizers of deliberative processes try to limit what will be considered as acceptable evidence. other methods are to reach a consensus among the participants up front which expertise should be included in the deliberation or to appoint representatives of opposing science camps to explain their differences in public. in many cases, participants have strong reasons for questioning scientific orthodoxy and would like to have different science camps represented. many stakeholders in environmental decisions have access to expert scientists, and often such scientists will take leading roles in criticizing agency science. such discussions need to be managed so that disagreements among the scientific experts can be evaluated in terms of the validity of the evidence presented and the importance to the decision. it is essential in these situations to have a process in place that distinguishes between those evidence claims that all parties agree on, those where the factual base is shared but not its meaning for some quality criterion (such as "healthy" environment), and those where even the factual base is contested (foster ) . in the course of practical risk management different conflicts arise in deliberative settings that have to be dealt with in different ways. the main conflicts occur at the process level (how should the negotiations be conducted?), on the cognitive level (what is factually correct?), the interest level (what benefits me?), the value level (what is needed for a "good" life?) and the normative level (what can i expect of all involved?). these different conflict levels are addressed in this subsection. first of all, negotiations begin by specifying the method that structures the dialogue and the rights and duties of all participants. it is the task of the chairman or organizer to present and justify the implicit rules of the talks and negotiations. above and beyond this, the participants have to specify joint rules for decisions, the agenda, the role of the chairman, the order of hearings, etc. this should always be done according to the consensus principle. all partners in the negotiations have to be able to agree to the method. if no agreement is reached here the negotiations have to be interrupted or reorganized. once the negotiation method has been determined and, in a first stage, the values, standards and objectives needed for judgement have been agreed jointly, then follows the exchange of arguments and counter arguments. in accordance with decision theory, four stages of validation occur: • in a first stage, the values and standards accepted by the participants are translated into criteria and then into indicators (measurement instructions). this translation needs the consensual agreement of all participants. experts are asked to assess the available options with regard to each indicator according to the best of their knowledge (factual correctness). in this context it makes more sense to specify a joint methodological procedure or a consensus about the experts to be questioned than to give each group the freedom to have the indicators answered by their own experts. often many potential consequences remain disputed as a result of this process, especially if they are uncertain. however, the bandwidth of possible opinions is more or less restricted depending on the level of certainty and clarity associated with the issue in question. consensus on dissent is also of help here in separating contentious factual claims from undisputed ones and thus promotes further discussion. • in a second stage, all participating parties are required to interpret bandwidths of impacts to be expected for each criterion. interpretation means linking factual statements with values and interests to form a balanced overall judgement (conflicts of interests and values). this judgement can and should be made separately for each indicator. in this way, each of the chains of causes for judgements can be understood better and criticized in the course of the negotiations. for example, the question of trustworthiness of the respective risk management agencies may play an important role in the interpretation of an expected risk value. then it is the duty of the participating parties to scrutinize the previous performance of the authority concerned and propose institutional changes where appropriate. • third stage: even if there were a joint assessment and interpretation for every indicator, this would by no means signify that agreement is at hand. much rather, the participants' different judgements about decisionmaking options may be a result of different value weightings for the indicators that are used as a basis for the values and standards. for example, a committed environmentalist may give much more weight to the indicator for conservation than to the indicator of efficiency. in the literature on game theory, this conflict is considered to be insoluble unless one of the participants can persuade the other to change his preference by means of compensation payments (for example, in the form of special benefits), transfer services (for example, in the form of a special service) or swap transactions (do, ut des). in reality, however, it can be seen that participants in negotiations are definitely open to the arguments of the other participants (i.e. they may renounce their first preference) if the loss of benefit is still tolerable for them and, at the same time, the proposed solution is considered to be "conducive to the common good", i.e. is seen as socially desirable in public perception. if no consensus is reached, a compromise solution can and should be reached, in which a 'fair' distribution of burdens and profits is accomplished. • fourth stage: when weighing up options for action formal methods of balancing assessment can be used. of these methods, the cost-benefit analysis and the multi-attribute or multi-criteria decision have proved their worth. the first method is largely based on the approach of revealed "preferences", i.e. on people's preferences shown in the past expressed in relative prices, the second on the approach of "expressed preferences", i.e. the explicit indication of relative weightings between the various cost and benefit dimensions (fischhoff et al. ) . but both methods are only aids in weighing up and cannot replace an ethical reflection of the advantages and disadvantages. normative conflicts pose special problems because different evaluative criteria can always be classified as equally justifiable or unjustifiable as explained earlier. for this reason, most ethicists assume that different types and schools of ethical justification can claim parallel validity, it therefore remains up to the groups involved to choose the type of ethically legitimate justification that they want to use (ropohl , renn . nevertheless, the limits of particular justifications are trespassed wherever primary principles accepted by all are infringed (such as human rights). otherwise, standards should be classed as legitimate if they can be defended within the framework of ethical reasoning and if they do not contradict universal standards that are seen as binding for all. in this process conflicts can and will arise, e.g. that legitimate derivations of standards from the perspective of group a contradict the equally legitimate derivations of group b (shrader-frechette ). in order to reach a jointly supported selection of standards, either a portfolio of standards that can claim parallel validity should be drawn up or compensation solutions will have to be created in which one party compensates the other for giving up its legitimate options for action in favour of a common option. when choosing possible options for action or standards, options that infringe categorical principles, for example, to endangering the systematic ability of the natural environment to function for human use in the future and thus exceeding the limits of tolerability are not tolerable even if they imply major benefits to society. at the same time, all sub-dominant options have to be excluded. frequently sub-dominant solutions, i.e. those that perform worse than all other options with regard to all criteria at least in the long term, are so attractive because they promise benefits in the short term although they entail losses in the long term, even if high interest rates are assumed. often people or groups have no choice other than to choose the sub-dominant solution because all other options are closed to them due to a lack of resources. if large numbers of groups or many individuals act in this way, global risks become unmanageable (beck ) . to avoid these risks intermediate financing or compensation by third parties should be considered. the objective of this last section of chapter was to address and discuss the use of decision analytic tools and structuring aids for participatory processes in environmental management. organizing and structuring discourses goes beyond the good intention to have all relevant stakeholders involved in decision making. the mere desire to initiate a two-way communication process and the willingness to listen to stakeholder concerns are not sufficient. discursive processes need a structure that assures the integration of technical expertise, regulatory requirements, and public values. these different inputs should be combined in such a fashion that they contribute to the deliberation process the type of expertise and knowledge that can claim legitimacy within a rational decision-making procedure (von schomberg ). it does not make sense to replace technical expertise with vague public perceptions, nor is it justified to have the experts insert their own value judgements into what ought to be a democratic process. decision analytic tools can be of great value for structuring participatory processes. they can provide assistance in problem structuring, in dealing with complex scientific issues and uncertainty, and in helping a diverse group to understand disagreements and ambiguity with respect to values and preferences. decision analysis tools should be used with care. they do not provide an algorithm to reach an answer as to what is the best decision. rather, decision analysis is a formal framework that can be used for environmental assessment and risk handling to explore difficult issues, to focus debate and further analysis on the factors most important to the decision, and to provide for increased transparency and more effective exchange of information and opinions among the process participants. the basic concepts are relatively simple and can be implemented with a minimum of mathematics (hammond et al. ) . many participation organizers have restricted the use of decision analytic tools to assist participants in structuring problems and ordering concerns and evaluations, and have refrained from going further into quantitative trade-off analysis. others have advocated quantitative modelling as a clarification tool for making value conflicts more transparent to the participants. the full power of decision analysis for complex environmental problem may require mathematical models and probability assessment. experienced analysts may be needed to guide the implementation of these analytical tools for aiding decisions. skilled communicators and facilitators may be needed to achieve effective interaction between analysts and participants in the deliberative process whose exposure to advanced analytical decision aids is much less, so that understanding of both process and substance, and therefore transparency and trust, can be achieved. many risk management agencies are already making use of decision analysis tools. we urge them to use these tools in the context of an iterative, deliberative process with broad participation by the interested and affected parties to the decision in the context of the risk governance framework. the analytical methods, the data and judgement, and the assumptions, as well as the analytical results should be readily available and understood by the participants. we believe that both the risk management agencies and the interested groups within the public that government agencies interact with on environmental decisions should all gain experience with these methods. improper or premature use of sophisticated analytical methods may be more destructive to trust and understanding than helpful in resolving the difficulties of complexity, uncertainty, and ambiguity. bioterrorism, preparedness, attack and response. elsevier beyond the job exposure matrix (jem): the task exposure matrix (tem) chapter occupational safety and health and environmental risks a task exposure database for use in the alumina and primary aluminium industry work-related neck and upper limb musculoskeletal disorders. european agency for safety and health at work finnish national job-exposure matrix (finjem) in register-based cancer research. people and work toimivat ja 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Ökologie und ethik. ein versuch praktischer philosophie. ethik in den wissenschaften zur ethischen bewertung von biodiversität. externes gutachten für den wbgu. unveröffentlichtes manuskript decision theory and folk psychology towards a comprehensive conservation theory the limits to safety? culture, politics, learning and manmade disasters environmental standards. scientific foundations and rational procedures of regulation with emphasis on radiological risk management the art and science of negotiation what mainstream economists have to say about the value of biodiversity benefits, costs, and the safe minimum standard of conservation decision analytic tools for resolving uncertainty in the energy debate Ökologisch denken -sozial handeln: die realisierbarkeit einer nachhaltigen entwicklung und die rolle der sozial-und kulturwissenschaften ein diskursives verfahren zur bildung und begründung kollektiv verbindlicher bewertungskriterien a model for an analytic-deliberative process in 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nature. a theory of environmental ethics meanings, understandings, and interpersonal relationships in environmental policy discourse. doctoral dissertation designing an analytic deliberative process for environmental health policy making in the u.s. nuclear weapons complex the framing of decisions and the psychology of choice perspectives on uncertainty and risk akzeptanzbeschaffung: verfahren und verhandlungen the erosion of the valuespheres. the ways in which society copes with scientific, moral and ethical uncertainty can participatory democracy produce better selves? psychological dimensions of habermas discursive model of democracy welt im wandel: erhaltung und nachhaltige nutzung der biosphäre. jahresgutachten discourse in citizen participation. an evaluative yardstick the craft and theory of public participation: a dialectical process a brief primer on participation: philosophy and practice system, diskurs, didaktik und die diktatur des sitzfleisches konsens als telos der sprachlichen kommunikation? in: giegel biophilia: the human bond with other species rio" oder die moralische verpflichtung zum erhalt der natürlichen vielfalt risk and social learning: reification to engagement die modernisierung der demokratie im zeichen der umweltproblematik wandelt sich die verantwortung mit technischem wandel? key: cord- - aj hz authors: macpherson, douglas w.; gushulak, brian d. title: health screening in immigrants, refugees, and international adoptees date: - - journal: the travel and tropical medicine manual doi: . /b - - - - . - sha: doc_id: cord_uid: aj hz nan health screening in immigrants, refugees, and international adoptees douglas w. macpherson and brian d. gushulak it is much more important to know which sort of a patient has a disease than to know what sort of disease a patient has. in an increasingly globalized world, migration and population mobility are important factors in the demographic makeup of national populations. in the united states, for example, recent estimates indicate that the foreign-born cohort comprises some million people, or % of the total population. many foreign-born individuals arrive as immigrants, refugees, or children adopted abroad. as such, and depending on their status, health screening may be a required or recommended component of their migratory process. migration-associated health screening is undertaken for two major purposes. first, screening may help identify medical conditions that have implications in terms of personal and community health. second, foreign nationals seeking residence through organized immigration and refugee programs undergo screening due to legislative, regulatory, or administrative directives and mandates. similar epidemiologic principles govern the science and application of both screening processes. however, the rationale underlying these two screening approaches differs in terms of historical basis, operational characteristics, and ultimate goals. • screening for medical conditions of personal health significance is intended to improve health parameters or outcomes for the migrant and may not be legally required or mandated. • mandatory medical screening for immigration purposes is undertaken for regulatory reasons, such as the determination of admissibility on medical grounds under immigration legislation. reflecting the duality of screening related to migrants, this chapter on screening is presented in two parts. the routine examination of travelers and migrants is one of the oldest recorded activities directed at civic administration and protecting the health of the public. the development of european quarantine practices in the mid- th century was associated with the routine inspection of new arrivals, commercial goods, and conveyances in an attempt to prevent the introduction of epidemic infectious diseases. those deemed to be at risk following inspection were contained, excluded, or expelled. these early public health activities accompanied the european settlement of the americas. shortly after achieving nationhood, early legislative tools were introduced creating the us public health service, whose initial role was to provide medical care to seafarers and to control the importation of serious diseases epidemic at the time, such as cholera and plague. a linkage to immigration later followed, with the screening of immigrants to exclude those with unwanted medical conditions such as certain loathsome diseases, individuals of suspected low moral behavior, and people with mental deficiencies who were likely to become wards of the state. in the united states, this process began in the late s when the control of immigration was legally recognized as a congressional responsibility. subsequently, the us immigration act of made specific reference to controlling the admission of immigrants on medical grounds. the routine medical inspection of immigrants was legislatively mandated in the united states in . public health programs and policies designed to manage the major medical challenges of the day became linked to the routine medical inspection of immigrants on arrival. by the s, the immigration medical inspection was extended to the european points of origin for the majority of migrants, creating a system of pre-departure immigration medical screening that continues to this day. the legal basis governing inadmissibility to the united states because of health-related conditions and authorization to undertake medical examination to determine that admissibility is found in the immigration and nationality act (ina) (title us code). under these provisions foreign aliens residing outside of the united states can be denied visas and rendered ineligible to enter the country. these provisions also extend to foreigners already residing in the united states who apply to become permanent residents. the immigration medical examination provides the opportunity to determine whether the foreign national (known as an "alien" in the legislation) is ineligible for permission to enter the united states (known as class a conditions) or has an illness or disorder that may interfere with independent self-care, education, or employment or may require future extensive medical treatment or institutional support (known as class b conditions). health-related reasons that exclude admission (class a conditions) to the united states include: . a communicable disease of public health significance . a physical or mental disorder or behavior posing a threat to property, safety, or welfare (either currently present or likely to recur) . drug abuse or addiction . failure to present documentation demonstrating having received recommended vaccinations. the department of health and human services provides specific regulations (medical examination of aliens cfr, part ) to define and implement the health aspects of the ina. these regulations identify those who require medical examination, outline the process, define where and by whom the examinations are performed, and list the specific conditions associated with inadmissibility. the regulations also define conditions or disorders that, while not serious enough for exclusion, are significant enough (class b conditions) that they must be brought to the attention of consular authorities. the division of global migration and quarantine at the centers for disease control and prevention (cdc) administers the regulations. currently, the regulations list the following as communicable diseases of public health significance: • for example, smallpox, poliomyelitis due to wild-type poliovirus, cholera, or viral hemorrhagic fevers (including ebola) currently a medical examination is required for all refugees entering the united states and all those applying for an immigrant visa from outside the united states. foreign residents in the united states applying to become permanent residents also require mandated medical examinations. panel physicians, designated by consular officers of the us department of state, perform medical examinations abroad, and civil surgeons, designated by the us citizenship and immigration services, perform medical examinations for aliens who are already present in the united states. both groups of physicians receive technical instruction and guidance from the cdc's division of global migration and quarantine. detailed medical history and physical examination are required for all individuals (see summary in table . ). in addition, applicants who are ≥ years undergo routine chest radiography and serologic testing for hiv and syphilis. those between and years of age who reside in a country where tuberculosis incidence rates (based on who data) are ≥ per , have either a tuberculin skin test (tst) or an interferon gamma release assay (igra). if either the tst or igra are positive, the individual undergoes chest radiography. depending on the clinical history, tst, igra, and radiological findings, supplementary screening requirements for tuberculosis include smears of respiratory secretions for acid-fast bacilli and cultures for tuberculosis. any positive cultures undergo drug susceptibility testing. those rated class a for tuberculosis (smear-positive infectious) generally must be treated until their sputum smears are negative before they are allowed to transit for immigration. those rated class b for tuberculosis are cleared for travel within certain time limits. failure to journey to the united states within those time limits will require the individual to undergo rescreening. since , individuals applying for immigrant visas to entry into the united states have had to demonstrate proof of vaccination for several vaccine-preventable diseases. initially, these were general, routine vaccinations as recommended by the advisory committee for immunization practices (acip) for the domestic us population. in , however, specific criteria for those requiring an immigration medical exam were adopted by the cdc. those criteria are: . the vaccine must be age appropriate (as recommended by the acip). and . at least of these two conditions must be met: a) the vaccine must offer protection against a disease with the potential to cause an outbreak. b) the vaccine must protect against a disease that has been eliminated or is being eliminated in the united states. at the time of the preparation of this chapter, required vaccines were: pre-admission vaccination requirements do not apply for refugees or non-immigrant visa applicants. however, those individuals are required to meet the vaccination standards when they adjust their status in the united states after admission. as a procedural consequence, the immunization status of refugees is recorded during immigration process. in the case of children adopted abroad, the vaccination requirements do not apply to those years of age or younger. however, the adoptive parents must sign documentation stating that they are aware of us vaccination requirements and will ensure that all required vaccinations will be received within days of the child's arrival in the united states. the importance and cost-effectiveness of preventative medical interventions in the overseas environment, before transit to the united states, is receiving greater attention as a potential part of the immigration medical process. currently, some refugee populations being resettled in the united states who are determined to be at increased risk for specific infections receive population-based treatment for malaria and intestinal parasites in addition to the routine immigration medical screening. additionally, outbreaks of communicable diseases in refugee camps or transit facilities can trigger additional interventions or treatment prior to arrival. in terms of harmful behavior, immigration medical screening is intended to identify those with neurologic or behavioral conditions associated with the risk of "ever causing serious injury to others, major property damage or having trouble with the law because of a medical condition, mental condition, or influence of alcohol or drugs" or "ever taken actions to end your [the applicant's] life." high-risk conditions in this group may be determined to be class a (inadmissible) or class b (admissible) conditions by panel physicians, depending on clinical findings, history, and situation. drug abuse or addiction (dependence) presents a class a (inadmissible) situation. those barred from admission are those who: • use a controlled substance (defined by the controlled substances act) and • meet the diagnostic and statistical manual of mental disorders criteria for a mild, moderate, or severe substance use disorder. it is sometimes possible for those individuals subject to medical examination who are determined to have a communicable disease of public health significance to still enter the united states. the legislation provides for a waiver process by which those determined to be inadmissible may request entry subject to conditions. documents providing further operational descriptions on the immigration medical screening process for both applicants abroad and those applying within the united states, including details on applicants seeking a change in immigration status, the use of panel physicians and civil surgeons, and reporting requirements, are available at http://www .cdc.gov/immigrantrefugeehealth/. mandatory medical screening to determine medical inadmissibility for immigration purposes is an important administrative process for applicants for permanent residency in the united states and may also be applied to certain temporary resident applicants. although the immigration medical examination does screen for some important medical conditions, it has clinical limitations. it is not designed to be a tool for identifying personal health risks, and it is procedurally limited to specific disorders and conditions of regulated public health concern. as a consequence, pre-existing medical conditions that do not fall under the immigration medical screening profile and other medical conditions of personal health significance may not be detected or reported during mandatory immigration screening. those conditions, while not relevant for immigration purposes, can be significant for new arrivals, and their identification and clinical management in the united states is important in some migrant populations. in addition to an absolute increase in immigration, there has been a shift in source countries, with immigrants from latin american nations other than mexico, as well as africa, asia, and oceania, increasingly contributing to the immigrant pool. the growing number and increasing diversity of foreign-born residents of the united states is important in numerous areas of clinical practice. local health environments at their place of origin and relative disparity in health and disease indicators mean that some migrants may have disease exposure and acquisition patterns different from those at their new home. in some communities, migrants represent rapidly increasing components of the population, and their specific health concerns may be different from those of the receiving community. international adoptions, for example, are now a major component of the adoption process in the united states. of the approximately . million adopted children less than years of age in the united states, % were foreign born, representing more than , individuals. appropriately targeted and applied screening can assist in meeting the differential health challenges of these diverse foreign-born populations. increasing cultural and linguistic diversity can pose challenges to health systems and for physician and institutional healthcare service delivery. health screening of immigrants and refugees can be done as part of primary care assessment in which routine immunizations should be documented and brought up-to-date if necessary; maternal-child health issues can be addressed; and specific health assessments for other defined populations (e.g., children, adolescents, women, and the elderly) can be performed. in addition to language, some migrant groups experience difficulty accessing and utilizing healthcare services for other reasons. cultural issues, including fear of interacting with official bureaucracies and concerns about affordability, may limit migrants' use of health prevention and promotional services. services designed for the general populations often include health counseling and screening programs that may be unfamiliar to or underused by migrant populations. medical and health conditions of importance in new arrivals in the united states fall into two groups: those conditions for which existing screening programs are available for the local population that also occur in migrants, and those conditions not common or endemic in the united states affecting particular populations of migrants for which no routine screening programs exist in the united states. migrants may need special attention in terms of screening for: • risk behaviors, such as smoking, alcohol, and other substance abuse • health implications of diet and exercise • risks of sexual health practices • early recognition of mental and psychosocial health • impact of environmental risks presented by toxic substances, including lead in drinking vessels or paint • occupational exposures related to safe labor practices. in addition, there are many targeted health promotion activities for specific groups, such as maternal-child care, which may not have been commonly available for many migrants in their home countries. programs such as prenatal blood pressure monitoring, screening for gestational diabetes, and thyroid function may be unfamiliar to many migrants. antenatal screening for infections such as rubella, syphilis, hepatitis b, and hiv can be important in migrant populations who originate from regions of the world where these diseases are more prevalent than they are in the united states and where screening practices are not uniformly available or are unfamiliar to women. there are other important targeted screening programs of relevance to migrants. they may not have had access to genetic screening for inborn errors of metabolism or physical conditions such as congenital hip dysplasia and cataracts. additionally, there are several diseases that may be more prevalent at the migrants' place of origin, such as malaria, thalassemia, and micronutrient deficiencies, for which screening may be indicated. finally, it is important to note that many migrants may be unfamiliar with the basis and rationale underlying health-screening programs. common examples include screening programs for malignant disease such as uterine cervical dysplasia (pap smear) and skin, bowel, breast, and prostate examinations. depending on their location and status, many other migrants may have never been screened for common illnesses such as diabetes and hypertension. this is particularly true for vulnerable and disadvantaged migrant groups, such as refugees, asylum seekers, and migrants displaced by conflict. healthcare disparities affecting access due to language and culture can occur, but also in some health jurisdictions in the united states there are legislative initiatives that may create barriers to available healthcare services on "right of access" based on citizenship or "willingness to pay" (self-pay or medicare entitlement). migrants' use of unregulated medical service providers may be an important component in the subsequent health assessment of this population. migrant populations may also be using traditional, herbal, alternative, or complementary medicines, some of which will be imported from abroad. unregulated therapies and agents that do not meet standards of pharmacologic care in united states may not be revealed to attending healthcare professionals unless diligently sought. these alternate therapies may have the potential to complicate clinical presentations and in some cases may themselves be a source of illness. many migrants from diverse backgrounds also have significant disparities in health determinants (e.g., socioeconomics, behavior, genetics and biology, environment) directly related to the migration process. the pre-departure component of health determination is carried through the migration process and is affected by the transit conditions, particularly for irregular arrivals, the post-arrival period, and any return travel undertaken by migrants or their offspring. for the healthcare professional providing services to migrants, this requires an in-depth knowledge of the geographic components of health determination and disease expression that will be carried over to low prevalence or non-endemic countries, such as the united states. the historical focus of immigration and international public health has tended to be on contagious diseases of epidemic potential such as trachoma, syphilis, tuberculosis, and, recently, hiv/acquired immune deficiency syndrome (aids). however, there has been a recent shift in attention to the personal health risks associated with immigration and other infectious and non-infectious diseases. table . presents some of the clinical screening issues for healthcare providers working with defined migrant populations. with globalization of economies and trade, rapidity of interregional transportation, and increasing international population mobility for temporary and permanent relocation, healthcare professionals will increasingly need both to recognize imported clinical syndromes and to be sensitive to quiescent conditions of both personal and public health significance when dealing with migrants. screening can be targeted at asymptomatic individuals or can be mass community screening of previously defined at-risk populations; both of these are based on demographic and biometric profiles representing disparity in frequency or severity of outcome. increasingly in high-health service regions with low prevalence of any poor health indicators and excellent local public health programs, migrants and other mobile populations are becoming the continued "at risk" populations. many of the factors impacting on adverse health outcomes in migrants are amenable to screening, and there are effective interventions for health promotion or disease prevention. high-risk populations of migrants, including refugees, workers, adopted children, victims of torture, and trafficked individuals, may require specialized medical care as well as specifically designed screening based on medical and sociological assessment of their needs. professional healthcare providers, health educational, training, and professional societies, and governments and nongovernmental agencies will be challenged to develop policies and programs to respond to this emerging and dynamic challenge to address the health needs of internationally mobile populations. advisory committee on immunization practices infectious disease issues in adoption of young children centers for disease control and prevention. technical instructions for panel physicians and civil surgeons detailed background and instructions related to us immigration medical screening practices disparities in preventive health behaviors among non-hispanic white men: heterogeneity among foreign-born arab and european americans article describing the differential knowledge and practice of preventive health measures by foreign-born and native-born populations strategies in infectious disease prevention and management among us-bound refugee children recent overview of infectious disease challenges in pediatric refugee populations destined to the united states the foreign-born population in the united states data on the demography of the scope and diversity of the us foreign-born cohort population mobility and infectious diseases: the diminishing impact of classical infectious diseases and new approaches for the st century review article outlining the importance of communicable diseases in migrant populations that are not usually subject to routine immigration medical screening globalization of infectious diseases: the impact of migration article describing and outlining the influence of population mobility on global disease epidemiology disease surveillance among newly arriving refugees and immigrants-electronic disease notification system, united states recent review of the scope and status of systems in the united states to identify and notify state health departments of diseases in migrants new approaches in a globalizing world review article that outlines how modern migration challenges traditional disease-control practices unauthorized immigrant totals rise in states, fall in : decline in those from mexico fuels most state decreases. pew research center's hispanic trends project statistics and demographic analysis of the unauthorized/irregular foreign-born population in the united states population-based comparison of biomarker concentrations for chemicals of concern among latino-american and non-hispanic white children an example of disparities in environmental health risks present in foreign-born populations screening of international immigrants, refugees, and adoptees albendazole therapy and enteric parasites in united states-bound refugees article that describes enhanced pre-departure screening and treatment for high-risk migrant populations in certain circumstances office of minority health. minority population profiles immigrant medicine. elsevier, philadelphia. reference text on the health aspects of migration key: cord- -ipv npdy authors: torreele, els title: business-as-usual will not deliver the covid- vaccines we need date: - - journal: development (rome) doi: . /s - - - sha: doc_id: cord_uid: ipv npdy governments must become active shapers of medical innovation and drive the development of critical health technologies as global health commons. the ‘race’ for covid- vaccines is exposing the deficiencies of a business-as-usual medical innovation ecosystem driven by corporate interests, not health outcomes. instead of bolstering collective intelligence, it relies on competition between proprietary vaccines and allows the bar on safety and efficacy to be lowered, risking people’s health and undermining their trust. in the early weeks of , the world was alerted to the emergence of a new deadly infectious respiratory disease, covid- , caused by severe acute respiratory syndrome coronavirus (sars-cov- ). first reported in china, it rapidly spread across the globe. without effective treatments or vaccines available, the response to the pandemic has so far largely relied on infection control measures such as hand hygiene, personal protective equipment including masks, physical distancing and restrictions on movement which have included variable periods of lockdown of cities, countries or regions. by late september, over one million people had died from covid- , among over million people diagnosed. given the enormous health, social and economic impact of the continued spread of covid- , which is nowhere near being under control, it is no surprise that a lot of hope is set on finding a vaccine. with massive financial support from governments, in particular the us, the uk, other european countries, as well as china and russia, researchers and companies engaged in what soon became a frantic race to develop vaccines against covid- . so far, an unprecedented amount of public funds (estimated at over bn us$) has been poured into vaccine research and development (r&d) and manufacturing, resulting in over vaccine candidates in clinical trials and many more in the pipeline. touted by many as a major tour de force, the ongoing 'race' towards a vaccine is also exposing the intrinsic deficiencies of relying on for-profit pharmaceutical companies, that are governed by trade rules, financial speculation and market competition, to ensure the development of essential health technologies. in fact, it risks delivering vaccines that are neither adequate nor widely accessible and may stand in the way of a truly effective global response to the pandemic. vaccinating against infectious diseases has proven to be a highly cost-effective public health intervention, combining individual and population-wide health benefits, if certain conditions are met. these are in the first place that the vaccine(s) must be safe and effective, and widely available to vaccinate the populations that can most benefit from it. depending on the disease, how it is transmitted and how contagious it is, an effective vaccine would ideally protect against infection, or else, it may only protect from getting (seriously) ill, or dying, or from further spreading the disease. an additional condition is that vaccines be deployed through an appropriate vaccination strategy. who and when to vaccinate, including priority allocation if vaccine availability is limited, are informed both by the epidemiology and the vaccine's properties, and may need to be adapted over time as the pandemic evolves and more vaccines become available. vaccine development and optimal use as public health intervention therefore depends on continuous data-driven assessment of benefits and risks in the context of the evolving pandemic, with the view of maximizing the public health impact of vaccination strategies. this is particularly important during a public health emergency like covid- , where vaccine development, regulatory review of candidates and their deployment will occur under intense clinical, economic, and political pressure (avorn and kesselheim ) . the way in which the commercial and geopolitical 'race' for a vaccine is playing out, however, risks side-lining these critical public health objectives in an r&d process that hinges on the privatization and commercialization of knowledge, and is focused on being first to get a vaccine to market (torreele a ). there currently is no mechanism to ensure that the best possible vaccines are being developed and deployed. the classic approach to vaccine development is that private companies invest in r&d based on their own proprietary platform technologies (vectors, delivery systems, adjuvants), in which they integrate a specific antigen to adapt to the target disease. despite a pipeline of nearly vaccine r&d projects, the 'race' to get a vaccine to market fastest does not incentivize the best science for public health interest. instead, it favours fragmentation and secretive competition, and precludes the free exchange of knowledge and learning from each other's successes and failures in real time, or a public health-driven and collaborative portfolio approach. none of the individual elements of each proprietary platform is necessarily the best suited for a covid- vaccine, but each company will only research within the boundaries of the its proprietary technology (covered by patents), hands tied from using other and possibly better fit elements that are owned by competitors. this is antithetical to a collective intelligence effort that would allow scientists all over the world to creatively combine the best elements of our medical knowledge and technological advances into a diverse and innovative portfolio of vaccine candidates with the best chance to achieve our common public health goal (torreele b) . failing moreover to compare the performance of the different candidates directly, the current process is bound to create a portfolio of suboptimal candidates that are neither the best in their class, nor diverse or complementary. in our supply-driven innovation system (in which the market is considered the ultimate arbiter), there is no public health mechanism to demand or impose that companies develop products according to pre-set and public health-driven performance criteria. as a result, less than optimal candidates can move through the pipeline, if sufficient resources are poured into it. in april , the world health organization (who) published a target product profile (tpp) for covid- vaccines with minimal and ideal vaccine characteristics to guide developers. it lays out safety and efficacy targets, to be demonstrated in people of all age groups, ethnicities and including subpopulations with certain co-morbidities. the who target product profile also outlines preferred features to make the vaccine well-suited for a large-scale interventions, for instance good temperature stability and a single dose regimen, or scalable and low-cost manufacturing. unfortunately, who's target product profiles are only aspirational and vaccine developers are under no obligation to comply with such criteria and ensure the products they are developing will be adequate as a public health intervention. and regulatory authorities are not empowered to demand that either. while there exists no absolute threshold for vaccine efficacy, who's tpp proposes that vaccines should have a minimum efficacy of % to be a useful tool against covid- . to effectively curb the pandemic and reach adequate population immunity, it has been calculated that vaccines should be - % effective in preventing infections (bartsch et al. ) . it remains uncertain how useful vaccines with much lower efficacy can be, or vaccines that only reduce disease severity, or only work in certain subpopulations (avorn and kesselheim ) . in any case, the tpp and the different ways in which vaccines can work must be considered when designing clinical trials for covid- vaccine candidates. in the current r&d model, it is left at the discretion of companies to set the vaccine efficacy targets they will measure in the clinical trials, which moreover they design, conduct and analyze themselves, notwithstanding the conflict of interest given their vested interest in the outcome (quigley ) . moreover, the study protocols that detail what is being compared in such trials, and how meaningful differences are going to be measured, are generally kept confidential for the public, as are the full study data and analyses. a milestone resolution on transparency around medical r&d was passed at the world health assembly (fletcher ), yet governments so far have failed to implement these commitments, despite huge financial investments in covid- r&d that could have been used as leverage to demand transparency on scientific methods and data, as well as clinical trial costs, and set performance targets for the vaccines. as companies' primary goal is to obtain marketing approval from regulators, they will design trials in ways that gives the fastest and easiest way to success, which does not necessarily coincide with asking the clinically most relevant questions. when front running covid- vaccine developers moderna, pfizer, and astrazeneca ceded to public pressure and shared their phase iii trial protocols, we learnt that they are indeed designed to get quick answers, not to demonstrate the vaccines are truly effective (doshi and topol ) . and while the three protocols differ in the details of how they measure efficacy (which conveniently will make the results impossible to compare) they all look at reducing the number of mild covid- cases as primary endpoint. the more clinically relevant endpoint of reducing severe disease and death would take longer to achieve (given that only a minority of those infected develop severe disease), as would demonstrating that the vaccine protects against infection altogether-which is the most desirable form of efficacy. who has proposed a collaborative efficacy trial, called 'solidarity', that would allow to directly compare the performance of different vaccines in light of the tpp. however, commercial vaccine developers prefer to set up their own placebo-controlled trials rather than have their vaccines compared to other candidates by independent researchers and held up to stringent public health targets. and while contrary to good scientific practice, governments too have chosen speed and political expediency over quality, generously supporting company trials as part of their geopolitical vaccine race through funding and access to public clinical trial infrastructure and capabilities. meanwhile, leading scientists advising who are left to plead in scientific journals for trials to look for 'worthwhile efficacy' (krause et al. ) , lacking ways to impose public health imperatives to commercial developers. only radical transparency of clinical trial protocols and data, and a robust and independent review of the results will allow to ensure we fully understand the performance, and limitations, of each vaccine, and restore trust that study conclusions are valid (torreele c) . amidst growing antiscience and anti-vax tendencies, it is critical that commercial and other vested interests are being removed from the assessment of covid- vaccines, allowing public health scientists, vaccination experts and other relevant stakeholders full access to the data and analyses to redress the already shaken public confidence in public health interventions to control covid- (jha ) . a further risk of focusing on speed is that researchers may not take the time to work with communities to educate them about covid- , its risk, the promise of vaccines and the mechanics of developing them, including doing trials, and get communities on board for trials and use of the vaccine. in addition to the risks of suboptimal research ethics practices, this may also create barriers and delays for rollout afterwards, because of distrust, vaccine refusal, science misconceptions, etc. the vaccine r&d playing field is not designed to enable the best covid- vaccines to move forward based on scientific and public health merit. instead, it is shaped by wealthy countries and powerful actors like pharmaceutical corporations who place their bets (knaus )-allotting large amounts of money to propel a chosen candidate forward towards (possible emergency use) authorization. financial and industrial backing such as through operation warp speed, more than desirable product characteristics, will determine the likely winners of this race, for which the primary finish line is obtaining marketing approval-typically at the united states food and drug administration (fda) and/or the european medicines agency (ema). yet the criteria used by regulators to allow a vaccine on the market are not necessarily responding to the critical question at hand: which vaccine has the potential to significantly impact global public health outcomes for covid- ? the primary role of regulatory authorities is to safeguard the public against exposure to potential harmful products. regulators will assess the potential benefits and risks of individual vaccines based on the company's data and determine whether the presented benefit/risk balance justifies commercialization of that vaccine. it is not the role of regulators to determine if a vaccine is adequate to control the pandemic, nor prioritizing which one has better safety and efficacy. notably, in their decisions to give marketing authorization, regulators are not taking into consideration a company's intention to produce a vaccine at scale or make it available widely, nor what price they are planning to charge. this means that companies have no incentive nor obligation to prioritize anything else but speed in obtaining marketing approval, based on self-chosen measures of efficacy. in addition, as the race for a vaccine became fuelled by political, financial and populist pressures, regulatory authorities may not even be able to protect us from harm or futility. concerns among scientists and experts are growing over the political pressure the us administration is putting on the fda. especially the announcement that the fda would consider emergency authorization for covid- vaccines before phase trials are complete, has caused concern. if that happens, european countries will be hard pressed to follow suit. yet, as vaccine and public health experts keep emphasizing, robust phase efficacy trials are the only way to establish whether a vaccine is effective in protecting against infections and disease, and safe to administer to large groups. having become increasingly financialized (lazonick et al. ) , pharmaceutical corporations will not invest in r&d for products that do not constitute guaranteed and profitable business opportunities. despite the excellent public health value of vaccines, producing and selling vaccines is considered unattractive from a commercial perspective. mass manufacturing and distribution of low-cost products, with only marginal profits per unit, compares poorly to the growing medicines market with its uniquely profitable lowvolume specialty drugs for which companies can charge very high prices. at the same time, the r&d process for vaccines is typically lengthy and costly, with large clinical trials required to demonstrate that it will be safe to administer a product to many millions essentially healthy people, and also effective in protecting against a given disease. only a handful of companies dominate the global vaccine market, selling essentially variations of the same - existing vaccines, with relatively little innovation in new disease areas, despite many infectious diseases that could benefit from a vaccine. emerging infectious diseases are a case in point. as exemplified again with the - west african ebola outbreak that killed over , people, commercial r&d fails to deliver needed health technologies for outbreaks of infectious diseases. despite knowing the ebola virus and its lethal epidemic potential since the s, and vaccine research having advanced in the public sector, there was neither treatment nor vaccine available when a long expected major outbreak devastated guinea, liberia and sierra leone, and caused a global panic (torreele and olliaro ) . and while a consortium of mainly public partners came together to conduct a clinical trial in that demonstrated the safety and efficacy of a vaccine candidate, initially developed by canadian public health researchers and later licensed to merck, there was still no registered vaccine available when a new ebola outbreak hit drc in - . affirming the need for public responsibility to drive r&d to improve outbreak preparedness, a group of countries and donors came together in the wake of the west african ebola crisis to create the coalition for epidemic preparedness innovations (cepi), with the mandate to accelerate development of vaccines against outbreak diseases and ensure access. with a massive injection of public and philanthropic funds, in cepi started financing public-private partnerships aiming to bring candidate vaccines for mers-cov (also a coronavirus), lassa fever and nipah forward. in parallel, cepi also invested in generic vaccine technology platforms that could be quickly adapted to any emerging infection of a so far unknown pathogen, the socalled 'disease-x' (simpson et al. ) . as soon as sars-cov- emerged, cepi mobilized funds to apply existing vaccine technologies to covid- , piggybacking on earlier investments in disease-x and mers-cov programmes, thus quickly moving several candidates into clinical trials. taking advantage of the massive public subsidies that started flowing towards covid- r&d, both small biotechs and major pharmaceutical companies jumped on the opportunity to adapt or reorient their proprietary vaccine technology platforms towards covid- , allowing to fast-track what otherwise would require many years of research. for instance moderna's and biontech/pfizer's leading mrna vaccine candidates built on years of public and private research into the potential of rna and dna vaccines (yet none of them made into a vaccine approved for human use) (akpan ) . similarly, oxford university (who later partnered with astrazeneca), j&j, cansino and gamaleya have rapidly repurposed for covid- their adenovirus-based vaccine platforms which had been explored for many years and a variety of diseases, including most recently mers-cov, zika and ebola. despite each of these r&d efforts building on a wealth of earlier research by the global vaccine research communitymuch of which is traditionally done and funded by the public sector-the basis of our commercial r&d model is that universities and companies are allowed to appropriate such technology platforms as their own. governed by the world trade organization's trips agreement that obliged countries to grant and enforce patents on pharmaceutical 'inventions', medical knowledge and technologies have largely been privatized, owned and traded as commodities, even when of critical public health importance. as a result, vaccine candidates essentially move through the pipeline as speculative commercial assets, whose market valuation can be followed through the share price of the companies owning them. while governments generously subsidize the covid- vaccines candidates of a handful of companies, it is unclear whether the financing agreements are structured to recognize this co-investment and ensure there will be commensurate sharing of the resulting outcomes in terms of access and pricing (the agreements have remained confidential). realizing that providing global access to an eventual covid- vaccine would require manufacturing at unprecedented scale, governments also provided upfront investments in the companies' manufacturing capacity and infrastructure. not only have they agreed to massively finance the expansion of private vaccine manufacturing infrastructure, with seemingly little or no strings attached, they also agreed to pay for the actual manufacturing of large volumes of selected vaccines before their safety and efficacy is proven and committed to buy large volumes once they were approved (at undisclosed prices) through so-called advance purchase commitments (apcs) . on top of this, companies have negotiated confidential liability transfers to governments, in case the vaccines would exhibit side effects that were not observed in the accelerated r&d process (halabi et al. ) . in contrast to generic drug manufacturing, there is relatively little vaccine manufacturing capacity able to produce at large scale outside of the major (western) vaccine corporations, with the notable exception of the serum institute of india, that has taken many years to build its meanwhile state-of-the-art capability. while strictly speaking there is no such thing as generic vaccines, vaccine manufacturing is technologically much more complex than small chemicals, and setting up the production of an existing vaccine typically requires lengthy technology transfer, including know-how sharing, for a newcomer to become operational. the massive investments of governments into scaling up manufacturing capacity for the covid- candidates seem to have all gone into private companies under license from the 'originator' companies, which is a missed opportunity for the global health community to have invested in expanding the global technological capacity to produce vaccines as commons, and start challenging the oligopoly that now exists among major vaccine producers. taken together, the unprecedented public investments in r&d and manufacturing capacities for covid- vaccines, and the purchase commitments and liability transfers, all directly benefit companies that 'own' these technologies, and have come with little or no strings attached, de facto privatizing all those public investments and the control over potentially hugely important public health interventions, which essentially should have been global health commons. vaccines are a public health intervention which, more than any other, require people's collective buy-in and trust. while some people argue that having a covid- vaccine that works a little, and for some, is better than having no vaccine at all, there are major risks and opportunity costs for prioritizing speed over adequate efficacy and safety. roll-out of a weakly effective vaccine in fact could worsen the pandemic in multiple ways (krause et al. ) . if authorities wrongly assume there is a substantial reduction in risk in the population, they may choose to scale down other covid- control measures and re-open the economy. if the pandemic continues to grow despite having massively invested in vaccines, they may not be willing to continue investing in a potentially better next generation vaccines. similarly, if vaccinated individuals wrongly believe they are protected against infection, compliance with other protective measures such as wearing masks or physical distancing may be lowered. when people realize they get infected despite being vaccinated, their confidence in vaccines may drop, leading them to refuse other more effective vaccines that would become available later on. deployment of a marginally effective vaccine could also interfere with the evaluation of other vaccines. it may become challenging to find enough unvaccinated trial volunteers to enrol in new vaccine trials, while conducting a trial in a population that is partially protected due to prior (poorly effective) vaccination may lead to results that are very difficult to interpret. additionally, once a covid- vaccine gets approved, subsequent vaccine candidates will have to be compared to it rather than to a placebo. as this necessarily will be done via what is called 'non-inferiority' trials, there's a risk that vaccines with even worse performance might still get approved, a methodological quirk which has been referred to as 'bio-creep' (everson-stewart and emerson ). a final collateral effect of poorly effective vaccines is that the legitimacy of scientists and the scientific process might be undermined if researchers cannot prevent commercial interests to overtake quality science. from the early days of the pandemic, influential voices including un secretary-general antónio guterres, european president ursula von der leyen and political leaders and academics from all continents have argued that the exceptional nature and huge impact of the pandemic justifies that covid- vaccines must be considered 'people's vaccines', or 'global public goods', or 'global health commons' and be available and affordable (for free) to all. however, this voluntarist discourse has not been followed with consequent actions. instead, we've seen unapologetic vaccine nationalism (kamradt-scott ) from the us, soon followed by other wealthy countries including the european commission, signing bilateral deals with companies to reserve the majority of early productions for their own populations in what essentially is an unequal scramble for vaccines (callaway ) . a multilateral effort coordinated by who in the context of their accelerated access to covid technologies (act-a) initiative to also ensure vaccine availability for poorer countries in parallel (covax) has met with mixed success-lots of verbal support but so far limited concrete financial commitments. it is also being criticized for lack of transparency and representation from the countries for whom covax is supposed to deliver solutions. the main strategy used by governments to 'ensure' access is through signing advance purchase commitments with the front-runner vaccine developers (often in combination with significant investments in r&d and even manufacturing). while initially designed as a market fixing pull mechanism to incentivize companies to do r&d in directions they would not otherwise go, governments have perverted apcs to guarantee supply and buy up the first in line positions for once the vaccines become available, without even putting demands in terms of desired product profile or pricing. this further shifts the power imbalance between governments and vaccines companies, who successfully turned the covid- crisis to their advantage and positioned themselves as key to the solutions, while largely dictating the terms of engagement, not only for availability and access to vaccines in wealth countries but also globally. at the same time, acknowledging that there will likely be a period during which supply will not be able to meet demand, difficult discussions are ongoing about (principles for) fair and equitable allocation frameworks, both globally and within countries (samuel ) . while it is beyond the scope of this article to go into detail on these, it is important to highlight how allocation frameworks and vaccination strategies cannot be seen independently of the exact profile and characteristics of the available vaccines-which we still don't know. most critically however, having left ownership and control over the vaccines to pharmaceutical companies, we do not have a collective and public-health driven governance mechanism that is able to organize and steer vaccine allocation and access in ways that maximize health impact (mazzucato and torreele ). the race for a covid- vaccine exposes the many ways in which a proprietary and market-based r&d model is illsuited, by design, to deliver appropriate vaccines to implement effective vaccination strategies to tackle this pandemic. vaccines and other health technologies are particularly suited to be considered global commons and benefit from open scientific collaboration, especially when they protect us against infectious diseases that do not care for national borders, private (intellectual) property, shareholder value or market dynamics. policy makers all over the world can and must assume responsibility for delivering such global health commons and shape the r&d ecosystem accordingly. driving medical innovation in that direction requires a major shift in how governments see and exercise their role, from by-stander market fixing to proactive entrepreneurial states (mazzucato ) . instead of handing out subsidies and market commitments without strings attached, this means the active steering of innovation towards the desired product characteristics and mobilizing the collective intelligence of researchers globally (mazzucato ) . it includes shaping the incentives and rules for public and private sector collaboration, in particular knowledge management, to optimally work together towards achieving the public interest goals. the scientific community, with its wealth of public health and infectious diseases expertise could be a key driver to this effect, redefining health innovation to address public health needs, not commercial success. these ideas are not as far-fetched as one might thinkthe us department of defence, in particular through their defence advanced research projects agency (darpa), has long understood how to steer public and private sector innovators towards national strategic objectives, with distinctive success. darpa's strategic investments underly the us strength in military and space technologies (medeiros ) , and the rise of silicon valley (cameron ). as exorbitant drug pricing and lack of critical r&d for life threatening conditions, including the growing threat of antibiotic resistance, exposed the deficiencies of our pharmaceutical r&d ecosystem, alternatives rooted in the fundamental responsibility of states to actively shape medical innovation for the public interest have been proposed, for instance in the context of the un high level panel on access to medicines (torreele ). in the people's prescription report, mazzucato calls for a darpa for health, harpa: health innovation aimed at public value, while more recently, a fully publicly owned pharmaceutical 'industry' was proposed for the us (brown ) . while that may sound radical, especially in a us context, it is important to keep in mind that until recently, many countries including in europe had kept critical parts of the pharmaceutical value chain under the control of the public sector, in particular vaccines (blume ) . countries like brazil and thailand still have significant government involvement in their pharmaceutical production, contributing to their relative resilience and autonomy for the production of essential health products, for instance antiretroviral therapy for hiv/ aids (ford et al. ). deprived of access to the global commercial market, cuba has developed a strong public innovation system for health, responding to the country's health needs (pérez et al. ) . calls for stronger public leadership in medical r&d and access, and for transparency, are gaining traction in the context of covid- . from the early days, there have been calls to ensure that commercial monopolies do not stand in the way of access, and to consider the covid-related knowledge and technologies as knowledge commons. concrete proposals have been put forward to either share and pool knowledge, for instance through the meanwhile established who covid- technology access pool (c-tab), or else to not grant or enforce intellectual property rights on them, as the proposal of south africa and india to the wto for a covid- waiver on certain provisions of the trips agreement (silverman ) . open access to knowledge and technologies needed to respond to covid- would be a major step towards more autonomy for countries or regions to produce needed health technologies. it will also require establishing adequate infrastructure and capability and strategic government interventions (finance, science and technology, health systems, industrial policy etc.) to generate such health technologies and make available for the population. the announcement of eu president von der leyen to create a european barda may be an important step in that direction, at least for the region. however it will be important to ensure that its focus is squarely on improving people's health outcomes and deliver health technologies that are widely available and accessible. success must be measured in value for health, not for business. to that effect, this initiative must be firmly rooted in the existing european health innovation infrastructure, for instance through the proposed biomed europa (florio ) that could be adapted after the us national institutes of health, except focused of global health commons, not just de-risking the biomedical industry. collaboration with the private sector is welcomed, but the terms and conditions of the public-private partnerships must be governed by public health benefit (mazzucato and torreele ) , and include open collaboration, sharing of know-how, technologies and infrastructure, and building collective intelligence. instead of secrecy and competition, this approach embraces radical transparency, both on the scientific methods and data, and financially, detailing each one's contributions in investment and risk taking. to ensure truly global health commons, technology transfer to third countries who wish to develop their own capabilities should be built in from the start. humankind is facing a global health crisis, perhaps the biggest crisis of our generation. the decisions people and governments take now, and the values on which they rely, will likely shape the world for years to come, including our healthcare systems, our economy and our culture. the time has come for global leaders to consider vaccines and other health technologies as global health commons that must be available for all and reshape the medical r&d ecosystem towards delivering that. pooling knowledge: private medicine vs. public health? moderna's mrna vaccine reaches its final phase. here's how it works regulatory decision-making on covid- vaccines during a public health emergency vaccine efficacy needed for a covid- coronavirus vaccine to prevent or stop an epidemic as the sole intervention the erosion of public sector vaccine production. the case of the netherlands medicine for all: the case for a public option in the pharmaceutical industry the unequal scramble for coronavirus vaccines-by the numbers the government agency that made silicon valley these coronavirus trials don't answer the one question we need to know bio-creep in non-inferiority clinical trials world health assembly approves milestone resolution on price transparency, health policy watch may biomed europa: after the coronavirus, a public infrastructure to overcome the pharmaceutical oligopoly sustaining access to antiretroviral therapy in the less-developed world: lessons from brazil and thailand no-fault compensation for vaccine injury -the other side of equitable access to covid- vaccines we need more transparency in covid- vaccine development why 'vaccine nationalism' could doom plan for global access to a covid- vaccine covid- vaccines: pressure is on to ensure they go to the most needy, not the highest bidder, the guardian covid- vaccine trials should seek worthwhile efficacy capitalism is broken. the fix begins with a free covid- vaccine the entrepreneurial state how to develop a covid- vaccine for all, project syndicate this economist has a plan to fix capitalism. it's time we all listened science and technological innovation in health in cuba. results in selected problems remove the for-profit variable from clinical drug trials, health and human rights journal may who should get the covid- vaccine first? the equality vs. equity debate south africa and india urge wto to waive ip rights, widen access to covid- drugs and vaccines disease x: accelerating the development of medical countermeasures for the next pandemic the rush to create a covid- vaccine may do more harm than good collective intelligence, not market competition, will deliver the best covid- vaccines as politics trumps science in the race for a vaccine, who will protect public health? ebola in west africa is a wakeup call. what the ebola crisis tells us about our failing drug development system health innovation as a public good, submission to the un high level panel on access to medicines conflict of interest the author declares no conflicts of interest. key: cord- -vddwzeew authors: dhesi, surindar; stewart, jill title: the developing role of evidence-based environmental health: perceptions, experiences, and understandings from the front line date: - - journal: sage open doi: . / sha: doc_id: cord_uid: vddwzeew there has been renewed recognition that proactive strategies and interventions can address the social determinants of health, and the environmental health profession is well placed to effect positive change in many of these determinants. this qualitative research has revealed differences in the perceptions, experiences, and understandings of evidence-based practice among public health professionals from different backgrounds across different services in health care and local government in england. the absence of a strong tradition of evidence-based practice in environmental health appears to be a disadvantage in securing funding and playing a full role, as it has become the expectation in the new public health system. this has, at times, resulted in tensions between professionals with different backgrounds and frustration on the part of environmental health practitioners, who have a tradition of responding quickly to new challenges and “getting on with the job.” there is generally a willingness to develop evidence-based practice in environmental health; however, this will take time and investment. states that "most effective actions to reduce health inequalities will come through action within the social determinants of health" (p. ); however, the public health evidence base and policy decisions are commonly centered on a "downstream" medical concept of evidence-based practice rather than in the "upstream" social determinants of health focused on prevention of ill health (asthana & halliday, ) . this is true even where there is a commitment to tackling "upstream" determinants (popay, whitehead, & hunter, ) . to illustrate, there has been recent criticism of the chief medical officer's report on child health focusing on "health-care" services and "individual-level targets" and its failure to suggest action on wider issues (tillmann, baker, crocker-buque, rana, & bouquet, ) . others have also found that while policy commitments to address the social determinants of health are frequently made (in canada), these are often not implemented; instead, action is focused on promoting individual "healthy lifestyle choices" (raphael, , p. ) . just as in england, it is argued that ontario's public health units have generally neglected the social determinants of health (brassolotto, increasingly involved in tackling other public health issues such as obesity. rehfuess and bartram ( ) suggest a useful definition of eh interventions: "any modifications to the natural or physical environment, or behaviours relating directly to them, which are undertaken with the intention to protect or improve public health" (p. ). they add that such interventions are complex and require methods of evaluation which take into account the many factors involved. the local authority eh function includes a regulatory or enforcement role, which differentiates it from other public health occupations. there remain tensions in meeting these often narrow regulatory requirements and leading on wider public health, both in policy and practice. rather than taking an holistic approach, eh has tended to fragment into administrative silos, including food safety, occupational health and safety, housing and environmental protection, and in what has been described as "action-oriented" fields (eyles, ) . this, coupled with the challenges of measuring the effectiveness of action on complex public health issues in the short-term (bauld & judge, ) , presents difficulties in developing the evidence base required to persuade decision-makers of the legitimacy and cost-effectiveness of proactive interventions. consequently, there has been a substantial impact on the ability to adopt an evidence-based system in eh. the development of an evidence base for tackling the social determinants of health, and an evidence base for eh are separate issues. however, they are also highly interlinked and interdependent. we therefore address them together here. this article presents the findings of empirical research exploring eh practitioners' perceptions, and the challenges faced, around the adoption and use of evidence-based practice in the new english public health system. specifically, four key themes are discussed: perceptions of evidencebased practice, practical challenges and their implications, relationships with public health colleagues, and responding to the demand for evidence-based eh. public health arrangements in england recently underwent significant organizational change when health service-based public health practitioners formally moved to local authorities on april , . this followed historical restructuring in , when public health medicine joined the national health service (byrne, ; stewart, bushell, & habgood, ) , leaving eh in local authorities, contributing to challenges we describe. health and wellbeing boards (hwbs) went live at the same time as the restructure; these are local government led committees charged with setting the local strategic direction for health, including public health, bringing together representatives from health and local authorities. the new system has required all public health professionals, whether formerly health service or local authority based, to work more closely to improve health and well-being and tackle health inequalities in their local populations (department of health, ). however, eh practitioners do not have a secure and mandated place on hwbs and have been found to be largely "invisible" to their colleagues in the wider public health system (dhesi, ) . the new arrangements provide an opportunity for investment in "upstream" preventative actions that are evidence based. however, there remain concerns that a medical model which values randomized controlled trials above other forms of evidence will predominate. there is an urgent need for those in eh and their partners to ensure a refocus on the social determinants of health, to tackle the causes and not just the effects of poor health. importantly, observers have noted that funding for health promotion activities is now linked to evidence-based practice and that "this is now the norm" (dunne, scriven, & furlong, , p. ) . however, they add that the evaluation of work to create this evidence base requires investment, and it is clear that work is required in both policy and practice to establish the effectiveness of preventative strategies and interventions which are the core of eh work. looking at the wider context, several commentators have noted the impact of a tough financial climate (d. hunter, south, & gamsu, ) , public service and benefit cuts (winters, mcateer, & scott-samuel, ) , neoliberal policies (mccartney et al., ; mooney, ) , and austerity policies particularly affecting deprived areas (barr & harrison, ) , all impacting on public health and widening health inequalities. indeed eh is located within local government, which has been subject to significant financial cuts in recent years. evidence-based public health is a fairly new idea and has been identified as being "of particular relevance to environmental health" (rehfuess & bartram, , p. ) . it has been noted that because of the complex and often "wicked issues" with which public health wrestles, there is much debate over what counts as evidence and how it can best be applied in different contexts. evidence doesn't exist in a vacuum-how it is presented and by whom are key issues which can determine its value and uptake. even where respected evidence resources exist . . . awareness of them remains poor in many local authorities. and getting their findings into practice locally can be problematic. (d. hunter et al., ) d. j. hunter ( ) also adds that "an evidence-informed public health is probably the best that can be hoped for" (p. ) and murphy ( ) critically notes the move to policy-based evidence making from evidence-based policy making in recent health reforms. the concept of public health "evidence" itself is tricky: it can be uncertain, change, and be overruled by politics (killoran & kelly, ; stewart, ) . others have suggested that science and politics are particularly intertwined in the field of regulatory science (strassheim & kettunen, ) , and fafard ( ) argues that there should be a reduced focus on scientific evidence in favor of ideas that take into account the realities of how this evidence translates into public health policy. the evidence base can also be inaccessible to many at the front line of practice; as access by local government public health practitioners to peer-reviewed papers has typically been limited. the evidence relating to the social determinants of health necessarily comprises a range of factors, including information and analysis, surveillance, research, evaluation, local knowledge, and good practice (i.e., what works, and why), and rehfuess and bartram ( ) note the value of systematic reviews here. marks ( ) identifies "three factors commonly held to have influenced the shift towards evidence based practice in the uk are cost-containment, quality assurance and the purchaser/provider split in the internal market of the nhs" (p. ), and it may be for this latter reason that a medical model still prevails. another likely factor is the period of time the medical evidence base has been relied upon and added to, while other evidence bases-for example, in public health, where the situation is often more empirically complex and less easy to tease apart-have lagged behind. as we have described, these areas have developed outside health services and have different and complex functions. in addition, the time lag between interventions and outcomes for public health interventions can be significant, a challenging issue in such a fast moving policy context, where initiatives are often time-limited and subject to change. although there have been calls for an evidence base, it is not always clear what this means, what this evidence might look like, and how practitioners might develop their skills and competencies to use and contribute to this evidence base. it has been argued (in nursing) that a wide understanding of what constitutes "evidence" is appropriate, including practitioner and patient experience and local contextual information (harvey et al., ) . it is clear that such outcomes can be difficult to measure and require quantitative and qualitative data founded on a range of methods (asthana & halliday, ) to explain what works well and why. it also needs to be fit for purpose, continually evaluated, and revisable as well as being accessible (muir gray, ; trinder, ) . eh is balanced between regulatory (statutory) functions which are legally required to be carried out and wider nonstatutory functions which are discretionary. elements of the regulatory frameworks in which they operate are not necessarily health outcome specific, for example, performance measurement on the numbers of food hygiene or occupational health and safety inspections carried out. although hazard and risk have become increasingly factored into regulation, other issues such as a requirement to enhance social capital or community cohesion are not. prioritizing of regulation in some areas, often as a result of policies of austerity, has left little space for a wider focus in the social determinants of health for those at the front line of eh practice where there is potential for greater health impact. what is lacking is the routine use of, and contribution to, a robust evidence base to shape how eh practitioners tackle the social determinants of health on which their daily work is focused, in ensuring safe living and working conditions for their local populations. historically, eh practitioners and other local authority professional groups did have access to service delivery and improvement support, including information on evidence for practice, from organizations such as the audit commission, the idea, and lacors; however, murphy ( ) finds that these forms of support for local authorities have been substantially reduced in recent years, and this is reflected in the findings that we present below. of particular relevance here is the suggestion that moving toward a greater focus on the social effectiveness of intervention programmes, based on a "shared understanding between researchers and practitioners," is needed. this should focus on how social relationships can be reconfigured in public health programmes (rod, ingholt, sørensen, & tjørnhøj-thomsen, , p. ). interdisciplinary becomes important in practitioner engagement in intervention research, methods, and social theory. this is key in eh, which in many areas tends to revolve around intervention and exit to meet regulatory requirements, and this in itself does not contribute toward a wider social change that could have far greater impact. crucially, others have found (in town planning) that, where both evidence-based public health guidance exist against regulatory guidance, the former is likely to have limited impact (allender, cavill, parker, & foster, ). the results presented here form part of a larger qualitative research project which utilized longitudinal case studies over a period of months, ending in july to explore how the new english hwbs were tackling health inequalities, focusing on eh. the authors are academics and environmental health practitioners (ehps) (one actively practicing), and the implications of this on the research, including the use of professional networks, interviewing peers, and dealing with challenging findings, have been reported elsewhere (dhesi, ) . all participants in the research were aware of the lead authors' professional background; the second author was not involved in data collection or analysis. the project was approved by the university of manchester ethics committee. four case study sites in the midlands and north of england, each a hwb, were followed more than months, from early , and interviews were carried out with eh professionals from all english regions. multiple case studies were chosen for theoretical replication (yin, ) , and case study sites were selected for maximum variation including both unitary and two-tier local government structures, deprived and affluent, and urban and rural areas. the methods used at each case study site were semi-structured interviews with hwb members, support officers, and eh practitioners and managers ( ). this was further supported by observation of hwb meetings ( ), and analysis of documents produced by hwbs, such as strategies and minutes of meetings. each case study site was recruited by approaching the chair of the hwb, either directly following an introduction or through an intermediary. hwb members were asked whether they were willing to take part in the research at the first meeting attended, and all participants were provided with an information sheet or summary of the research. all interviewees gave their informed consent and were given an opportunity at the end of the interview to raise any additional issues they felt were relevant. interviews were carried out in a location of the interviewee's choice. of the interviews, were with eh practitioners or managers, and their roles are made clear in the findings presented below. eh is a graduate profession, and so levels of education were not explored; however, interviewees were asked to explain their current roles and backgrounds. with the exception of one eh manager who had worked in a related regulatory field, all had worked previously as eh practitioners. data was analyzed thematically both inductively and deductively using the qualitative analysis software atlas ti. and tested for bias with non-eh research colleagues. the findings have been divided into four themes: perceptions of evidence-based practice, practical challenges and their implications, relationships with public health colleagues, and responding to the demand for evidence-based eh. each is discussed in the context of the literature and with illustrative examples. a primary challenge was what was understood by evidencebased practice and how this applies to eh. with tensions between regulatory activities and wider public health work, also comes a tension between the social determinants of health and individual lifestyle issues, and action at societal level against a focus on the individual. this relationship between management of existing services and leadership in achieving public health outcomes was important. there was an expectation that evidence-based practice will be the norm for public health professions in the new system, whatever their backgrounds and employing organizations. eh interviewees, whether practitioners or managers, repeatedly said, "we just get on with it," lacking the time or resource to take stock to evaluate their actions, and to develop evidence to prioritize for the greatest impact. indeed, there were no notable differences in opinion between eh practitioners and managers across the thematic findings. eh practitioners follow statutory guidance, codes of practice, and informal evidence based on practical knowledge and experience, but tend not to engage directly with the academic literature. established performance indicators were felt to be an issue, and some questioned why food hygiene inspections at specific intervals, for example, received such attention when there was little robust evidence to demonstrate whether this was an effective use of resource (eh practitioner id ). interviewees often observed that new approaches are needed to demonstrate their value and secure funding for their services, particularly for discretionary functions, in the new system. this research has also found that eh practitioners see themselves as "doers" compared with other public health colleagues as "thinkers," and the development and use of evidence to inform practice is key in this perception (eh manager id ). many eh managers felt that relying on fixed outputs rather than public health outcomes as a measurement of effectiveness made them vulnerable to a loss of resources: . . . if your service is doing well and you don't have the numbers of prosecutions and notices served, or homelessness cases, you know, there's a temptation for the [elected] members to think that there's too much capacity in those areas, they're thinking there isn't a problem, therefore, we don't need so many staff, but it's actually the front line work that's going on that's preventing that kind of thing. (eh manager id ) interestingly, several interviewees reported negative experiences of evidence-based practice and felt that the concept was limiting, both in terms of innovation in dealing with novel problems and in speed of response: . . . why are we so fixated with "evidence based," because . . . it actually hampers emerging subjects . . . so it's like being pioneers of making interventions work-if there's no evidence there does that mean we can't have the money to actually do it in the first place? or is everything a pilot? (eh manager id ) another interviewee expressed concerns that evidence-based practice was being used in a very limited way, resulting in a backward focus: we only know about what we have been doing, we don't even research that well enough but we certainly don't research what we could be doing-and so everybody who is looking at the evidence base is looking for the things they are already doing, well that's a distortion we can't live with. (eh practitioner with national role id ) as in the wider literature, the view that evidence-based practice was a good thing in itself was clearly not universally held. this seemed to be related to perceptions around limiting the role of professional judgment and room for innovation. this perception is of concern, as evidence-based practice should allow for account to be taken of the context, and of professional judgment. greenhalgh ( ) in a recent commentary notes that in public health, "success of interventions depends on local feasibility, acceptability and fit with context-and hence on informed, shared decision making with and by local communities . . . " (p. ). it is clear that a common understanding of evidence-based practice is needed, which includes room for professional judgment, flexibility, and innovation based on the local context and preferences. on a practical level, very many interviewees reported feeling unable to provide the evidence required of them and described the challenges of collating credible information, maintaining momentum, and measuring the outcomes and value of eh work. as an example of challenges on the ground, an eh manager (id ) described frustration when negotiating for time to measure longer-term outcomes in a system where short-term measures are of greater interest, citing a smoking cessation project where funding was threatened when there were no improvements measured after months. there was a general feeling among interviewees that eh outcomes are difficult to evaluate. this was true across preplanned inspections around how "worthwhile" they were, as well as wider projects that were frequently not fully evaluated and results disseminated (eh manager id ). this view is supported by the literature in other fields; for example, social workers face similar issues (dodd & epstein, ) and others have taken steps to encourage practitioner research and publication and to embed evidence-based practice in social care (aveyard & sharp, ; aveyard, sharp, & woolliams, ; fronek, ) . there was seemingly limited consideration of how to develop a body of high quality and persuasive evidence in both policy and practice. again this sits with a wider literature of how we understand and implement "upstream" evidence-based practice; there is still some way to go. there also appeared to be a perception that the required evidence will be quantitative or "medical"; however, the concept of what the evidence actually is remained unclear and this was a challenge (eh practitioner id ). others felt that there was a lack of the "right sort" of evidence needed to influence decision making: . . . what i see in terms of what evidence will be used to make decisions and, without a doubt, most of it is medical; there is still a lack of environmental/social evidence, i think that is of higher status and powerful enough to affect decisions, so i think as well, it is much easier to churn out some of the medical data more quickly and some professions have much more of a culture of that than others. (eh practitioner and academic id ) there is not simply an issue with a lack of an evidence base; the type of evidence and the way it is presented are seen as crucial in eh being accepted as a public health profession of legitimacy and value and to attract funding as such. for instance, it was said that eh practitioners were carrying out effective work but did not have evidence required to demonstrate their impact to others: we must be looking at what's coming up and the innovation that we can do about what's already here, and getting a research base for that. and the reality is there's people out there experimenting every day of their life, but they don't realize they're doing it, and they're not recording it, well they're not doing it in an appropriate way perhaps, but they're not recording it either, and they're not sharing, absolutely, except in anecdotes. (eh practitioner with national role id ) there was a sense from the research findings that development and use of evidence to inform practice is still in rudimentary stages, and there was little mentioned by way of ideas in what should be done to tackle the "causes of the causes," and this shortage of "upstream" evidence has also been noted by others (asthana & halliday, ). an eh manager considered evidence-based practice a "luxury" rather than a necessity, where resources are tight, but had hopes for future joint working. this perhaps represents the real challenge faced: we're a streamlined service, we don't have much fat on the makeup of the teams and finding time to look into research, look into developing and building baseline data that you can work from is something that we don't have the luxury of being able to do, that's one of the things i'm hoping, public health coming in to local authorities might help us with. (eh manager id ) it appears that eh needs to urgently respond, if it is to avoid missed opportunities. to illustrate, there were specific concerns that funding would be lost: . . . there hasn't been the research done to be able to just go and find a paper that says: "environmental health-this project should be funded-because it makes this much impact." that research doesn't exist-or it hasn't been published. (eh practitioner id ) others were concerned that the lack of evidence would affect the ability of eh to engage effectively with hwbs contributing to local public health strategy: . . . if we really want to have an impact on those boards and in strategy and also make sure they've got the right resource-you have to have the right research and the background to prove your case. (eh manager id ) it is clear that interviewees felt that the lack of an evidence base was having an impact not only on the perception of eh as a public health profession but also on the ability to play a full role strategically and in securing funding for services. however, it is also possible that the joint strategic needs assessment (jsna) may offer eh practitioners an opportunity to build and develop an evidence base. others alluded to a skills gap in eh, but this was mentioned infrequently and indirectly, including the fact that much of the information was available but not sufficiently evaluated or disseminated to maximum effect. the loss of audit commission national reports are also significant here, and issues around practical challenges chime with murphy's ( ) research findings relating to sports services, where there were concerns around they type of evidence used for decision making, difficulty in evaluating health impacts of interventions, and underdeveloped skills to carry out the evaluation required. the perceived need for evidence-based practice has added a layer of complexity, and also sometimes tension between public health professions as they are required to co-operate and may be competing for limited funding. there is optimism, however, that many issues can be overcome by working more closely together, learning from others, and playing to their relative strengths. several interviewees reported that the combination of expectation of evidence-based practice and lack of available evidence in eh had caused tensions with public health colleagues from different backgrounds, with one interviewee describing it as "like a religion in medicine" (eh manager id ). others described this expectation to follow evidencebased practice as the cause of frustrating delays where fast responses were required, again reinforcing the eh practitioner idea of themselves as "doers," although their role requires much "thinking"; however, this appears to be unappreciated by many. there was a commonly held view that being "doers," eh practitioners were at an advantage in able to respond quickly to new and emerging public health issues (eh manager id ). one interviewee described an uncomfortable meeting with public health colleagues, when they questioned the use of the medical evidence-based practice norm to secure funding (eh practitioner id ). there was, however, some hope that the relocation of health service colleagues to local authorities would facilitate a combined skill set able to plug the evidence gap in eh: . . . if we can make use of analysts, statisticians that are coming in from the pct [now superseded] we then, possibly, [will] be in a better position to start contributing better and making a stronger argument when it comes to looking at priorities. (eh manager id ) others also reported that colleagues with health service backgrounds had "their finger on the pulse" as regards evidence-based practice and had more success in describing impact. there was hope that the restructure would enable eh (and other services) to learn lessons about accessing and incorporating evidence into practice (eh manager id ). this squares with wider issues around access to relevant evidence to inform practice; however, an eh manager expressed concerns that the move would lead to a loss of access to the evidence by their former health service colleagues. others felt that being able to demonstrate the value of eh work would make an impact in how the profession is perceived: if we do this and we show the benefits, then it's going to be a lot of benefit to us, because people will say, "well look, environmental health, they've really delivered here." (eh manager id ) the findings indicate that there are tensions between individuals and organizations in the new public health system. difficulties in partnership working between health and local authorities are not new and have been documented (evans & killoran, ) , with tensions arising from different worldviews, priorities, and ways of working. however, most research has focused on local authority social care; relationships between eh and other health and public health professions are under-researched and this area requires more attention as the new public health system becomes established. to thrive, there is a need to learn a new way for eh to demonstrate impact and effectiveness which will require a completely new approach and a greater sense of equality with public health colleagues. within the new public health structures, eh managers are starting to consider how they will measure the short-and long-term effects of their work to demonstrate impact and secure funding: we've barely scratched the surface of the analytics of some of the tobacco work, [but] we've actually got reasonable numbers about what we're doing. but big questions about does enforcement influence price? does it influence availability? what will an elected member get for their money? if they give us another enforcement officer will there be measurable health impact? are we just a finger in the dam wall and the best we can say is it's not getting any worse or are we actually making a difference? if we can actually show a meaningful cause and effect in terms of outcomes for say tobacco work i think the balance of spending from that would be different. (eh manager id ; emphasis added) in response to the practical challenges described earlier, multiple new skills are required, primarily not only in research and evaluation but also in novel forms of dissemination and presentation that attract the attention of those holding the purse strings. as an interviewee described, . . . it's how we present ourselves, how we get ourselves on a level playing field really. (eh manager id ) a recurrent theme appeared to be a disconnect between "getting on with the job" and reflection around how interventions might be evaluated and enhanced. this area seems particularly lacking, and as baum ( ) identifies, successful policies and practices need to address underlying causes of inequality and be founded in evidence. this shift in expectations requires a shift in practice around how new or unused skills in reflection, evaluation, and publication can be factored into already busy working regimes. when asked about why eh did not have a strong tradition of evidence-based practice, a variety of ideas were suggested; however, by far, the most common response was lack of time: . . . if your job is to . . . crunch out the statistics, because that's what it comes down to, how do you then find the time and the energy to do the things that actually might be more important and have more of an impact on health? (eh practitioner and academic id ) an interviewee, in comparing eh with other public health colleagues, felt that the issues should be overcome: . . . i spent a couple of days working for the hpa [health protection agency, now superseded], and i noticed how good they are at evidencing what they do-but it's part of their culture . . . when you read their monthly report book . . . it's just so professionally done . . . and you think should we be getting more serious about that in environmental health? i think we probably should be . . . (eh practitioner id ) there were two notable mentions of the successful use of evidence-based practice by eh managers, both working in cities, though in very different geographical areas and circumstances. the first relates to levering in funding for housing interventions to tackle health inequalities through quantifying costs and modeling for savings in health and other spending; we've had very long debates about outcomes and outputs because these things are so difficult to measure, if you're exposed to substandard housing the symptoms may not manifest themselves for , , years and there's no way you can have a sort of impact assessment or evaluation done in a short period of time, but what we are able to do is model . . . so ehos [environmental health officers] in year cost roughly £ , in salaries levered in by in terms of landlord improvements several hundred thousand pounds and will be saving, or are estimated to save the nhs £ . million over years and wider society £ million. (eh manager id ) the second manager had used a variety of approaches to demonstrate the effectiveness of their service: . . . on our project work we've done quite a bit of evidence based evaluation but it's been both qualitative and quantitative, so we have done quite a lot of feedback in a qualitative manner, so interviews as well as the nub of how many referrals, to whom and all that sort of stuff . . . and it is quite difficult when you get asked; right, what are your outcomes, what are you monitoring to actually come up with something that's useable. because we tend to deal with things over a longer term so it is quite difficult sometimes, but i think we're creative. (eh manager id ) these examples indicate evidence-based practice is possible within an eh setting and is already being successfully used in some areas to demonstrate the impact of eh work. however, only one of these positive examples has been published, and that in "gray" practitioner publications rather than peer-reviewed literature, and so the opportunity of others in the profession and wider system to learn from these experiences is limited. the value of "gray" literature to practitioners also very much depends on its quality assurance and availability. there was also some positivity expressed by interviewees around the practical steps that could be taken to start evaluating, including consideration at the planning stage of how success will be measured: although much was mentioned around the challenges of evidence-based practice, little was offered by way of concrete action. however, there are some signs that eh practitioners and managers feel that by evaluating their work in terms of outcomes, they will be able to demonstrate the health impacts, and there are indications that some public health decision-makers will be open to this evidence in terms of service funding, including, for discretionary work addressing the social determinants of health. there also needs to be an acknowledgment that time is needed for these activities as part of the "day job" if the best use of limited resources is to be identified. however, the value of "gray" literature such as technical reports, opinion pieces, and other unpublished work compared with peer-reviewed papers remains unclear in the practical context. recent housing case studies have been published (stewart, ) and housing "evidence bases" are available; however, it is unclear whether gray literature will be accepted as "evidence" sufficient to influence decision making and funding, and more research is needed. rehfuess and bartram ( ) suggest a new five-stage model for evidence synthesis on eh intervention effectiveness. they take into account the complexity of action on upstream interventions, including the "geographical, socioeconomic, political and cultural environment." the five stages are policy measures, programming, delivery, user compliance, and direct impact. while clearly requiring resources to action, it appears that this could be a useful tool for eh practitioners and managers in the new english public health system to make progress in a systematic way with demonstrating the value of their interventions in terms of public health outcomes. changes in the english public health system have brought the lack of disseminated eh evidence to the fore; in public health medicine, it is already considered relatively well established, and this has caused some tensions. although in the past there has been some sharing of best practice and other support, those working in local authority eh in particular have in recent years tended not to evaluate their work in terms of health impact and disseminate by publication. this needs to be addressed as a priority, as does continuing measurement on fixed outputs where the public health impacts are unknown. the very range of eh issues and the fact that some are founded in the social determinants of health and others as fragmented regulatory silos needs to be far more comprehensively addressed in policy and practice, widely understood, and founded in theory of what works and why. the organizational changes present new opportunities for greater multi-disciplinary working and learning, particularly in sharing skills around public health outcomes, access to literature, and opportunities to develop an accessible evidence base. many commentators (cited above) argue of the need to ensure a continued focus in the social determinants of health and evidence-based strategies and interventions that will be sustainable. there is a clear need for evidence of impact to be created and published, appropriately disseminated, incorporated into implementation plans, and reflected upon. rehfuess and bartram's ( ) proposed model for systematic evidence synthesis in eh could be a useful tool for practitioners, but this will require investment in expertise, time, and resources. eh professionals recognize this deficit, and while they may not all agree on the value of evidence-based practice in itself, they see that being able to demonstrate effectiveness in this way is necessary to survive and thrive sufficient to take action on upstream issues, particularly where these actions fall outside the narrow regulatory remit. interestingly, none of those interviewed referred to the former modes of support for best practice dissemination in local government, which have declined in recent years. there is some optimism among interviewees that the evidence base can be developed, particularly if efforts are made to work with other public health colleagues more familiar with the concept, but in a way that is valid and responds to both theory and practice in eh and health promotion more widely. in this way, eh may gain recognition for its work impacting on the social determinants of health. the dilemmas faced are multiple. the focus needs to be on establishing evidence-based eh, rooted in actions to tackle the social determinants of health and recognizing the need for flexibility around professional judgment, local context, and preferences; yet required performance indicators frequently skew resources in a different direction. funding cuts can lead to a retrenchment and focus on statutory functions and less resource to design and evaluate proactive and discretionary wider public health work. this article has presented data collected during a time of upheaval and change, where relationships and structures were often newly established, and it remains clear that further work is needed when systems are more established. the role of eh as a public health profession is greatly underresearched and is deserving of more attention. tell us something we don't already know or do!": the response of planning and transport professionals to public health guidance on the built environment and physical activity developing an evidence base for policies and interventions to address health inequalities: the analysis of "public health regimes a beginner's guide to evidence based practice in health and social care professions a beginners guide to critical thinking and writing in health and social care will plans for public health funding increase inequalities? new proposals for distributing money for public health will see councils in poorest areas receiving less than is currently spent by the nhs strong theory, flexible methods: evaluating complex community-based initiatives the commission on the social determinants of health: reinventing health promotion for the twenty-first century? epistemological barriers to addressing the social determinants of health among public health professionals in ontario, canada: a qualitative inquiry local government in britain a short guide to health and wellbeing boards reflexivity -researching practice from within exploring how health and wellbeing boards are tackling health inequalities practice-based research in social work: a guide for reluctant researchers funding linked to evidence: what future for health promotion? perspectives in public health tackling health inequalities through partnership working: learning from a realistic evaluation environmental health research: setting an agenda by spinning our wheels or climbing the mountain? beyond the usual suspects: using political science to enhance public health policy making evidence-based practice: in conversation with debbie plath (podsocs) evidence based medicine: a movement in crisis? what counts as evidence in evidencebased practice relationship between evidence and policy: a case of evidence-based policy or policy-based evidence? public health how local government can provide good leadership in public health. the guardian towards an evidence-based approach to tackling health inequalities: the english experience perspectives on evidence-based practice fair society, healthy lives: strategic review of health inequalities in england post making a bad situation worse? the impact of welfare reform and the economic recession on health and health inequalities in scotland (baseline report) the health of nations: towards a new political economy evidence-based practice: a critical appraisal public health and health and wellbeing boards: antecedents, theory and development sport, physical activity and the establishment of health and wellbeing boards in nottingham and nottinghamshire injustice is killing people on a large scale-but what is to be done about it a discourse analysis of the social determinants of health beyond direct impact: evidence synthesis towards a better understanding of effectiveness of environmental health interventions the spirit of the intervention: reflections on social effectiveness in public health intervention research a review of uk housing policy: ideology and public health effective strategies and interventions: environmental health and the private housing sector environmental health as public health when does evidencebased policy turn into policy-based evidence? configurations, contexts and mechanisms shortage of public health independence and advocacy in the uk. the lancet introduction: the context of evidence based practice assessing the impact of the economic downturn on mental health and wellbeing (observatory report series ) environmental health zena lynch very helpfully commented on several drafts of this article, and we are grateful for her input. the author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. the author(s) disclosed receipt of the following financial support for the research and/or authorship of this article: the national institute for health research (nihr) provided an element of studentship funding for the first author and the chartered institute of environmental health (cieh) contributed toward the cost of transcribing interviews. surindar dhesi is a chartered environmental health practitioner, lecturer and researcher at the university of birmingham. her phd research looked at health and wellbeing boards, health inequalities and environmental health in england. her current research interests include mapping public health and planning policies, and investigating environmental health conditions in the calais refugee camp in france.jill stewart worked in local government as an environmental health officer specialising in housing and social care before joining the university of greenwich. here she teaches across social work, public health and well-being programmes. jill is particularly interested in effective, integrated strategies and interventions with a focus on tackling inequality and alongside publishing books and papers, she has supported many new authors in publishing their work to add to the environmental health evidence base. key: cord- -kc thr authors: bradt, david a.; drummond, christina m. title: technical annexes date: - - journal: pocket field guide for disaster health professionals doi: . / - - - - _ sha: doc_id: cord_uid: kc thr . humanitarian programs ; . security sector ; . health sector : core disciplines in disaster health . primary health care programs . disease prevention . clinical facilities . reproductive health . water and sanitation . food and nutrition . chemical weapons . epi methods ; . tropical medicine : tropical infectious diseases—vector-borne and zoonotic . tropical infectious diseases—non-vector-borne ; . epidemic preparedness and response ; . communicable disease control : diarrhea . influenza . malaria . measles . meningitis . viral hemorrhagic fever ; . diagnostic laboratory : indications, laboratory tests, and expected availability . specimen handling ; . acronyms ; this section provides guidance on technical issues in the health sector. the annexes contain compilations of frequently used reference information. • humanitarian programs-contains conceptual frameworks on global clusters, relief programs, humanitarian financing, and early recovery. • security sector-contains key definitions from the rome statute of the international criminal court • health sector-contains a broad range of core health technical information including environmental classification of water and excreta-related diseases, disease prevention measures, water treatment end points, anthropometric classifications, micronutrient deficiency states, management of chemical weapon exposures, and epi methods. • tropical medicine-contains clinical summaries of tropical infectious diseases with details on disease vector and host, clinical presentation, diagnostic lab tests, clinical epidemiology, and therapy. • epidemic preparedness and response-contains core principles of epidemic preparedness and response. • communicable disease control-contains an overview of selected communicable diseases of epidemic potential including diarrhea, influenza, malaria, measles, meningitis, and viral hemorrhagic fever. • diagnostic laboratory-contains guidance on lab specimen handling and testing. • acronyms-contains acronyms commonly used in disaster management and humanitarian assistance. a. in-kind donations (eg food, seeds, tools, fishing nets, etc) b. types of community projects in food-for-assets programs ( ) natural resources development (a) water harvesting (b) soil conservation ( ) restoration of agri(aqua)culture potential (a) irrigation systems (b) seed systems ( ) infrastructure rehabilitation (a) schools (b) market places (c) community granaries (d) warehouses (e) roads (f) bridges ( ) diversification of livelihoods (a) training and experience sharing . increase individual purchasing power a. cash distribution b. cash for work (cash for assets) c. vouchers d. micro-credit e. job fairs f . artisanal production g. livelihoods/income generation . support market resumption a. market rehabilitation b. infrastructure rehabilitation c. micro-finance institutions goals-protect what's left ( month), restore the system ( months), improve the system ( . promote transformational development support far-reaching, fundamental changes in relatively stable developing countries, with emphasis on improvements in governance and institutions, human capacity, and economic structure, so that countries can sustain further economic and social progress without depending on foreign aid. focus on those countries with significant need for assistance and with adequate (or better) commitment to ruling justly, promoting economic freedom, and investing in people. reduce fragility and establish the foundation for development progress by supporting stabilization, reform, and capacity development in fragile states when and where u.s. assistance can make a significant difference. . support strategic states help achieve major u.s. foreign policy goals in specific countries of high priority from a strategic standpoint. . international cooperation to protect lives and health . timely and sustained high-level political leadership to the disease . transparency in reporting of cases of disease in humans and in animals caused by strains that have pandemic potential to increase understanding, enhance preparedness, and ensure rapid and timely response to potential outbreaks . immediate sharing of epidemiological data and clinical samples with the world health organization (who) and the international community to characterize the nature and evolution of any outbreaks as quickly as possible . prevention and containment of an incipient epidemic through capacity building and in-country collaboration with international partners . rapid response to the first signs of accelerated disease transmission . work in a manner supportive of key multilateral organizations (who, fao, oie) . timely coordination of bilateral and multilateral resource allocations; dedication of domestic resources (human and financial); improvements in public awareness; and development of economic and trade contingency plans . increased coordination and harmonization of preparedness, prevention, response and containment activities among nations . actions based on the best available science . genocide (article )-acts committed with intent to destroy, in whole or in part, a national, ethnic, racial, or religious group a. killing members of the group b. causing serious bodily or mental harm to members of the group c. inflicting on the group conditions of life calculated to bring about its physical destruction in whole or in part d. imposing measures intended to prevent births within the group e. forcibly transferring children of the group to another group . crimes against humanity (article )-acts committed as part of a widespread or systematic attack against any civilian population, with knowledge of the attack a. murder b. extermination c. enslavement d. deportation e. imprisonment in violation of international law f. torture g. rape, sexual slavery, enforced prostitution, forced pregnancy, enforced sterilization, or other comparable form of sexual violence h. persecution on political, racial, national, ethnic, cultural, religious, gender, or other grounds universally recognized as impermissible under international law i. enforced disappearance j. apartheid k. other inhumane acts intentionally causing great suffering or serious injury to body or to mental or physical health . war crimes (article ) a. grave breaches of the geneva conventions of aug ( ) willful killing ( ) torture or inhumane treatment including biological experiments ( ) willfully causing great suffering ( ) extensive destruction and appropriation of property ( ) compelling a pow to serve in the armed forces of a hostile power ( ) willfully depriving a pow of the right to a fair trial ( ) unlawful deportation ( ) taking of hostages b. serious violations of laws and customs applicable in international armed conflict ( ) intentionally directing attacks against the civilian population or against civilians not taking direct part in hostilities ( ) intentionally directing attacks against civilian objects ( ) intentionally directing attacks against personnel, installations, material, units, or vehicles involved in humanitarian assistance or peacekeeping mission ( ) intentionally launching an attack in the knowledge that it will cause incidental civilian loss of life or severe damage to the natural environment ( ) attacking undefended towns, villages, dwellings, or buildings which are not military targets ( ) killing or wounding a combatant who has surrendered ( ) improper use of a flag of truce, flag or insignia or uniform of the enemy or of the un, or emblems of the geneva conventions resulting in death or serious personal injury ( ) transfer by the occupying power of parts of its own civilian population into the territory it occupies, or the deportation or transfer of all or parts of the population of the occupied territory within or outside the territory ( ) intentionally directing attacks against buildings dedicated to religion, education, art, science, charitable purposes, historic monuments, hospitals, and places where sick are collected, provided they are not military objectives ( ) subjecting persons to physical mutilation or to medical or scientific experiments which are not justified by the medical treatment nor carried out in his/her interest ( ) killing or wounding treacherously individuals belonging to the hostile nation or army ( ) declaring that no quarter will be given ( ) destroying or seizing the enemy's property unless such be imperatively demanded by the necessities of war ( ) declaring abolished, suspended, or inadmissible in a court of law the rights and actions of the nationals of the hostile party ( ) compelling the nationals of the hostile party to take part in the operations of war directed against their own country ( ) pillaging a town or place, even when taken by assault ( ) a range of generic prevention measures should be considered for its impact on diseases in a biological "all-hazards" environment. overall, excreta disposal, water quantity, personal hygiene, and food hygiene commonly contribute more to environmental health than do other listed measures. epidemic threats will oblige heightened consideration of disease-specific strategies for prevention and control. c. water treatment (bold text of particular relevance in clinical facilities) ppm = mg/kg (solids) = mg/l (liquids) = ug/ml (liquids) = basic unit of measure for chloroscopes : , ppm = % • sam = whz < − , muac < . cm, or bilateral pitting edema (who). whm not in definition. • sam prevalence worldwide ≈ , , . • sam mortality ≈ x mortality of normally nourished child and its cfr can be - %. • gam = mam + sam • gam = moderate wasting cases, severe wasting cases, or bilateral pitting edema cases (where due to malnutrition) • underweight is not used for screening or surveys in nutritional emergencies. it reflects past (chronic) and present (acute) undernutrition and is unable to distinguish between them. it encompasses children who are wasted and/or stunted. however, weight gain over time can be a sensitive indicator of growth faltering which is easily tracked on road to health charts. • stunting generally occurs before age . it is irreversible. • stunting prevalence worldwide ≈ , , . • stunting is not a good predictor of mortality, but the cfr from ids in cases of severe stunting ≈ x the cfr from ids in cases without stunting. reference standards can be absolute muac, centile, % of median reference, or z scores: • muac easy to understand. an excellent predictor of mortality. permits comparisons between age groups insofar as the low growth velocity of muac in the u age group makes data roughly comparable. may be used alone in "quick-and-dirty" convenience samples to estimate local prevalence of wasting. however, not used alone in authoritative anthropometric surveys, and is commonly part of a two stage screening process to determine eligibility for feeding programs. • overall whz gives higher prevalence of malnutrition than whm for the same population. this is most marked where there is low baseline prevalence of disease, and especially for adolescents (who get subsequently over-referred). whz is more statistically valid, but whm is better predictor of mortality and is used for admission to tfcs. weight-for-age is influenced by weight-for-height and height-for-age. it can be difficult to interpret. b. adults and adolescents (o ) anthropometrics: bmi = weight (kg) / height (m) . death rates-calculated incidence of death expressed per , p/d or per p/mo; data collected by retrospective surveys (eg month period) to gauge severity of public health emergency particularly where sudden events lead to spike in mortality a. cdr-crude death rate b. asdr-age-specific death rate (eg u dr or death rate of children - yr) during a studied time interval (written as . mortality rates-calculated probability of dying before a specified age expressed per live births; data collected by national health authorities in periodic (annual) demographic surveys to reflect ongoing health status a. cmr-calculated probability of mortality in given population for specific time b. imr-calculated probability of a live borne child dying before yr c. u mr-calculated probability of a live borne child dying before yr nb mr ≠ dr. eg cmr ≠ cdr, u mr ≠ u dr. different rates measure different things and are not directly comparable. however, mrs may be converted into drs by the following: cdr or u dr (deaths/ , /d) = − ln( −p/ ) × . where p = cmr or u mr (deaths/ live births). however, this has little field utility. nb mmr-maternal mortality ratio has different units in numerators (maternal deaths) and denominators (live births), thus is a ratio, not a rate the application of study findings to an entire population from which the sample was drawn. if the survey was well-conducted, the results may be considered representative of the entire population. this is scientifically justified. however a confidence interval should accompany any parameter estimate of that population. extrapolation the extension of study findings to a population or period which was not represented in the sample. it works by association-if populations appear to be experiencing similar conditions, the morbidity/mortality experience of one may be imputed to the other. this is not scientifically justified, but is often done where data are insufficient or impossible to collect. s/sx think differential diagnosis (below). . severe muscle pain may be a symptom of sepsis even without fever. . elderly patients with sepsis may be afebrile. in elderly patients, fever is rarely caused by a viral infection. . septic patients who are hypothermic have a worse prognosis than those with high fever. treat as a medical emergency. . fever in a postoperative patient is usually related to the surgical procedure (eg pneumonia, uti, wound, or deep infection). . fever with jaundice is rarely due to viral hepatitis. think liver abscess, cholangitis, etc. . the rash of early meningococcal infection may resemble a viral rash. . generalized rashes involving the palms and soles may be due to drugs, viral infections, rickettsial infections, or syphilis. . all febrile travelers in or returned from a malaria infected area must have malaria excluded. . disseminated tb must be suspected in all elderly patients with fever and multisystem disease who have been in an area with endemic tb. . septic arthritis may be present even in a joint which is mobile. . back pain with fever may be caused by vertebral osteomyelitis or an epidural abscess. . a patient may have more than one infection requiring treatment (eg malaria and typhoid), especially if they are elderly, immunosuppressed, or have travelled. . always remember common infections, not just opportunistic infections, in aids patients with a fever. understand morbidity multipliers-measles, malnutrition, and tb/hiv. understand occult co-morbidities. for any undifferentiated illness, even in infants, think of hiv, tb, syphilis, and sarcoid. for any child, think of malaria, hookworm, and anemia. malarial anemia usually in pedes < year-old; hookworm anemia usually in pedes > year-old. for any icp, think of tb, vl, histoplasmosis, and strongyloides. must treat early. watch for clinical mimics-malaria presenting as pneumonia or diarrhea in pedes; vl presenting as malaria in adults; lepto presenting as mild df (esp in df endemic areas where the pt has mild onset of illness, worsening course, and no rash but jaundice). tx do basic things well, use equipment you understand, teach others, delegate. this annex profiles selected communicable diseases of epidemic potential whose incidence, management complexity, or mortality obliges particular attention. • if (+) agglutination to o antisera, then the strain is further tested for agglutination to antiserum of ogawa and inaba serotypes. • if (+) agglutination to o antisera, then the strain is not further subdivided (except as producer or non-producer of ct as noted below). • if (−) agglutination to o and o antisera, then the strain is known as non-o , non-o v. cholerae. a strain is further identified as a producer or non-producer of cholera toxin (ct). ct production is a major determinant of disease development. strains lacking ct do not produce epidemics even if from the o or o serogroup. • serogroup o exists as main biotypes-classical and el tor-though hybrids also exist. each biotype occurs as two serotypes-ogawa and inaba. classic biotype caused the th and th pandemics but little epidemic disease since the s though it still causes cases in india. el tor biotype caused the th (current) pandemic and almost all recent outbreaks. el tor was first isolated in in el tor, egypt after importation by indonesian pilgrims travelling to mecca. it survives longer in the environment and produces ct similar to the classical biotype. presumably because of ct pathogenicity, the % of cholera patients with severe disease has doubled over the past yrs. these patients tend to require iv fluid therapy. • serogroup o may have evolved from strains of o el tor as they share many properties though not agglutination. in spring of in dhaka, o cases exceeded o el tor cases for the first time, and it was postulated that o may become the cause of an th pandemic. however, since then, o has again become dominant. infective dose depends on individual susceptibility. relevant host factors include immunity produced by prior infection with serogroup o as well as stomach acidity. id may be , orgs, so personal hygiene plays a lesser role than in shigellosis where the id is much lower. shigella has species. • s. dysenteriae type (sd or shiga bacillus) causes the severest disease of all shigella sp because of its neurotoxin (shiga toxin), longer duration of illness, higher abx resistance, higher cfr thru invasive complications, and great epidemic potential. • s. flexneri is the most common, and is generally endemic, in developing countries • s. sonnei is the most common in industrial countries • s. boydii and s. sonnei give mild disease. some kinds of e. coli produce a shiga toxin. shiga toxin genes reside in a bacteriophage genome integrated into the bacterial chromosome. some abx, eg fluoroquinolones, induce expression of phage genes. the bacteria that make these toxins are variously called "shiga toxin-producing e. coli" (stec), "enterohemorrhagic e. coli" (ehec), or "verocytotoxic e. coli" (vtec). all terms refer to the same group of bacteria. • e. coli o :h (often called "e. coli o " or "o ") is the most commonly identified stec in north america, and it causes most e. coli outbreaks. approximately - % of ehec infections result in hus. • non-o stec serogroups also cause disease. in the usa, serogroups o , o , and o are the most commonly identified e. coli pathogens overall. weather (esp weeks - in apr-may) creating increased biological activity; post-monsoon (esp weeks - in aug-sep) with contamination of water sources. pre-monsoon epidemics are generally worse than postmonsoon ones. dysentery has low level year-round incidence, but epidemics occur roughly each decade. epidemic strains display new, additive antibiotic resistance which probably triggers the epidemic. once resistant strains have become endemic, antibiotic susceptibility rarely reappears. sd acquires resistance quickly. sf acquires it more slowly, and that resistance may wane with decreasing abx pressure. at icddr, annual proportional incidence approximates the following: clean water and waste management especially for cholera. personal hygiene (hand washing with soap and clean towels) especially for shigella. water safe drinking water (boiled, chlorinated) nb sphere standards are not enough-you need increased quantities of chlorinated water at household level. san clean latrines for safe disposal of excreta hand washing with soap food safe food (cooked, stored) breast feeding fomites safe disposal of dead bodies with disinfection of clothing nb after outbreak of a fecal-oral pathogen, food hygiene and funereal practices may influence human-to-human transmission more than water quality. health education to affected population wash hands with soap: after using toilets/latrines. after disposing of children's feces. before preparing food. before eating. before feeding children. dukoral has been the main vaccine considered for use in high-risk populations. • morc-vax and shanchol-similar to dukoral except they do not contain the rbs, hence do not require a buffer, and are / the cost to produce. morc-vax, produced in vietnam, is derived from a vaccine administered to millions of people since , but is not who pre-qualified, and is not expected to have international distribution. • shanchol, produced in india, has international distribution (eg used in the haiti cholera vaccination campaign of ), and is now the agent of choice for who. it confers immunity d p nd dose, effectiveness > % at mo, and protection > % at yr. also confers short-term protection vs etec. dose: . cc vaccine followed by water ingestion but no fasting needed; doses, wks apart; cold chain required except for day of use. • orochol-bivalent formulation as in dukoral without rbs of ct. dose: single dose. no longer manufactured. who recommendations: "vaccination should not disrupt the provision of other high-priority health interventions to control or prevent cholera outbreaks. vaccines provide a short-term effect that can be implemented to bring about an immediate response while the longer term interventions of improving water and sanitation, which involve large investments, are put into place." [ ] icddr recommendations: "because of limitations in terms of transport, formulation, and cost of the current dukoral vaccine, the cots program does not require the utilization of the vaccine during an outbreak; it is not necessary to vaccinate to overcome an outbreak. however, if dukoral is readily available and staff are properly trained in its use according to the guidelines that come with the vaccine, the cots program permits dukoral's use (ideally before an outbreak) in the following high-risk populations: refugee populations in which cholera is present, health care workers managing cholera cases, and communities in which the incidence rate is greater than in annually." [ ] epidemiological surveillance (specific to cholera) epidemiological assumptions (who, cots): estimated attack rates: - % extremely vulnerable hosts and poor environmental health (who) % (refugee camps with malnutrition) (cots) % (rural communities of < p) (cots) % (severe epidemic-good estimate of ultimate disease burden) (who) . % (endemic areas with bad sanitation) (cots) . % (endemic areas in open settings-suitable for initial calculations of early resource requirements) nb overall, % of cases are mild and difficult to distinguish from other types of d. nb asymptomatic carriers are very common ( x # of cases). referral rates for ivs % of cases (much higher- % at icddr as it shortens recovery time) case fatality ratios % (with good care) the following catchment populations will yield acute pts of whom will be severely dehydrated: refugee camp of people (ar of % = pts) open settings in endemic area with , people (ar . % = pts) a population of , infected individuals in an epidemic area will yield the following (who): population infected , clinical cases , ( % of infected population) cases needing early resources ( % of cases) cases needing iv therapy ( % of cases) anticipated deaths ( % cfr) nb in non-endemic areas, ar adults > ar pedes because adults have higher exposure risks. in endemic areas, ar pedes > ar adults because adults have been exposed since childhood delivery of health services shigella are fragile and difficult to recover if transport time > d. - isolates initially to confirm outbreak - isolates initially to create abx use policy (bacterial resistance renders cotrimoxazole, amp/amox, nalidixic acid, and tetracycline unusable) - isolates monthly from ipd and opd before abx therapy to assess evolving abx resistance - isolates periodically to reference laboratory to confirm abx resistance patterns and undertake molecular studies isolates at end of the outbreak to confirm that new diarrheas are not epidemic pathogens nb systematic sampling is most representative-eg every th pt or all pts q weeks adjusted as needed to collect the necessary specs. sensitivity > > important than specificity in rdt screening during an epidemic. pts from one geographic area are more likely to constitute a cluster involving a new pathogen. an area may be considered cholera-free after incubation periods (total of d) have passed without cholera disease. however, hospital monitoring should continue for a year due to tendency of enteric pathogens to re-emerge long after they are declared gone. cholera may be viable but nonculturable from the environment; environmental monitoring has many false negatives. consider improvements to existing diagnostic labs • hotline set up for reporting of rumor this often translates into a hastily conceived vaccination campaign that distracts from core principles of cholera management. for every symptomatic pt, there may be asymptomatic carriers. in an established epidemic, the affected community is already extensively infected. cholera vaccination, under these circumstances, has little public health benefit for the resource investment. if undertaken, the following will apply: • vaccination campaign requires numerous staff. community mobilizers are key. clinical staff should not be poached from their clinical duties. supervisors must be free to move at will. • logistics is key-if the st day goes badly, the campaign goes badly. • mark the domiciles which are done. • hold after-action meetings each day. • last day, use mobilizers with mobile broadcasting to attract those who missed out. • second phase vaccination should include chws with multi-purpose messages on water and sanitation. avoid: press exaggeration abx prophylaxis reliance on ivf and insufficient ors lab investigation of cases once epidemic etiology is ascertained prolonged hospitalization hospital discharge criteria requiring multiple negative stool cultures enthusiasm for ocv during epidemic exaggerated water purification objectives concentration of technical competencies in moh at expense of districts failure to share information with stakeholders influenza viruses comprise genera-influenza types a, b, and c-each with species. • influenza type a is divided into subtypes based upon serological response to hemagglutinin (ha) and neuraminidase (na) glycoproteins. there are different ha subtypes and different na subtypes. h n , h n , and h n are responsible for the major human pandemics in the last century. h n virus circulated between and but currently does not. only influenza a subtypes infect birds, and all subtypes can do so. bird flu viruses do not usually infect humans. but, in , an outbreak of h n avian influenza in poultry in hong kong marked the first known direct human transmission of avian influenza virus from birds to humans. since then, h , h , and h avian influenza subtypes have been shown to infect humans. • influenza type b is morphologically similar to a and also creates seasonal and epidemic disease. • influenza type c is rare but can cause local epidemics. seasonal human influenza vaccine currently has strains-h n /h n /b. influenza disease in humans has a short incubation period ( - d). early symptoms are non-specific. it is highly infectious, especially early in the course of the disease, with a large # of asymptomatic carriers. transmission potential (r ) is a function of infectivity, period of contagiousness, daily contact rate, and host immunity. in general, the faster the transmission, the less feasible is interrupting transmission thru usual disease control tools of case finding, isolation, contact tracing, and ring vaccination. • specific groups of exposed or at risk in the community-most likely to work when there is limited disease transmission in the area, most cases can be traced to a specific contact or setting, and intervention is considered likely to slow the spread of disease eg quarantine of groups of people at known common source exposure (airplane, school, workplace, hospital, public gathering; ensure delivery of medical care, food, and social services to persons in quarantine with special attention to vulnerable groups) (useless once there is community-based spread) eg containment measures at specific sites or buildings of disease exposure (focused measures to > social distance) cancel public events (concerts, sports, movies) close buildings (recreational facilities, youth clubs) restrict access to certain sites or buildings • community-wide measures (affecting exposed and non-exposed)most likely to work where there is moderate to extensive disease transmission in the area, many cases cannot be traced, cases are increasing, and there is delay between sx onset and case isolation. infection control measures ari etiquette-cover nose/mouth during cough or sneeze, use tissues, wash hands avoidance of public gatherings by persons at high risk of complications nb use of masks by well persons is not recommended "snow" (stay-at-home) days and self-shielding (reverse quarantine) for initial d period of community outbreak-may reduce transmission without explicit activity restrictions closure of schools, offices, large group gatherings, public transport (pedes more likely to transmit disease than adults) nb community quarantine (cordon sanitaire)-restriction of travel in and out of an area is unlikely to prevent introduction or spread of disease anopheles vector biology egg becomes adult mosquito in d adult mosquito becomes infective in d after bite on infected host susceptible human host becomes infective in d after bite from infected mosquito :. earliest human clinical disease in d after eggs are laid follow the -d rule: dusk and dawn stay indoors as much as possible with window screens in good repair dress in light colored long sleeve shirts and long pants when outside identify cause of the outbreak undertake vaccination campaign strengthen routine immunization and surveillance meningitis is a disease with significant mortality. meningococcus (neisseria meningitides) is renown for its rapid onset, rapid progression (death sometimes within hours), and high mortality ( % untreated). there are serogroups of neisseria meningitides but only (a, b, c, w, x, y) are known to cause epidemics. the bacteria spread from person to person via respiratory and nasal secretions. polysaccharide vaccines are available with serotypes (a and c), serotypes (a, c, and w) or serotypes (a, c, w, and y). duration of immunity is approximately years. meningococcal protein conjugate vaccines confer longer immunity but at higher cost than polysaccharide vaccines. monovalent conjugate vaccine against group c dates from , and tetravalent (a, c, w, and y) conjugate vaccine dates from . group b vaccine made from bacterial proteins has been licensed since but is not readily available. meningococcal vaccines have a very low incidence of side effects. regular disease surveillance is necessary to detect outbreaks. the epidemic threshold is suspected cases/ , population in any given week. two suspected cases of meningitis in the same settlement should trigger an outbreak investigation. nasopharyngeal carriage rates do not predict epidemics. - % of meningococcal disease presents with meningitis. % of cases occur in patients < y/o. peak incidence in meningitis belt is ages - yrs. diagnosis is straightforward when patient presents with signs of meningitis-fever, headache, vomiting, changes in mental status. however, most patients have non-specific illness - days before onset of meningitis. cfr of untreated meningococcal meningitis can be %. cfr of properly treated meningococcal meningitis is < %. - % of meningococcal disease presents with septicemia unaccompanied by meningitis or other focal features. it is a dramatic illness which affects previously healthy children and young adults. it presents with acute fever leading to purpura fulminans (hemorrhagic or purpuric rash), shock, and waterhouse-friderichsen syndrome (acute adrenal failure). etiologic diagnosis can be easily missed. cfr of meningococcal septicemia is % and may be % even with proper treatment. diagnosis may be confirmed by agglutination tests, polymerase chain reaction, culture and sensitivity testing of spinal fluid and blood. in many situations, these tests are not available. throat swabs may be helpful on occasions. do not delay treatment for tests or test results. minutes count. it is more important to have a live patient without a confirmed diagnosis than a dead one with a diagnosis. differential diagnosis in a tropical patient with fever and altered mental status, but without purpura or shock, includes cerebral malaria. co-infection may occur. standardized case management of bacterial meningitis in developed countries involves - days of parenteral antibiotic therapy. drug of choice in adults and older children is ceftriaxone which also rapidly eliminates the carrier state. alternate drugs include ampicillin and benzylpenicillin which do not eliminate the carrier state. in developing countries, days of parenteral antibiotic therapy are empirically shown to be effective. in large epidemics in resource-poor settings, a single im dose of chloramphenicol in oil is the drug of choice. for patients who do not improve in hours, a repeat dose may be given. viral meningitis is rarely serious and requires only supportive care, recovery is usually complete. patient isolation and disinfection of the room, clothing, or bedding are not necessary. respiratory precautions are advised particularly early in the course of treatment. chemoprophylaxis of contacts is available in some settings but rarely in the disaster setting. vigilance and education of close contacts is mandatory. epidemic preparedness and early detection of outbreaks are key. vaccines against n. meningitides serogroups a, c, y and w are very effective in controlling epidemics. in epidemic settings, children - are the priority target with serogroups a and c typically the priority antigens. rapid mass vaccination campaigns can contain outbreaks in - weeks. for immunocompetent patients over years, vaccine efficacy rate is % one week after injection. however, duration of immunity may be as little as years in younger children. in some countries, vaccine may also be used with close contacts of sporadic disease cases to prevent secondary cases. chemoprophylaxis of contacts is not recommended in epidemics, but community education and ready access to health care are essential. preventive medicine [ ] source control/reduction/elimination undertake quarantine and culling of sick reservoir animals and known disease carrier species. avoid unnecessary contact with or consumption of dead reservoir animals or known disease carrier species. avoid unnecessary contact with suspected reservoir animals and known disease carrier species (eg primates). avoid direct or close contact with symptomatic patients. establish appropriate communicable disease controls for burial of the dead. administrative controls (improve people's work practices) environmental and engineering controls (isolate people from the hazard) avoid needle stick exposure to blood specimens thru automated machine handling. ppe (protect people with ppe) use standard precautions-gloves, masks, and protective clothing-if handling infected animals or patients. wash hands after visiting sick patients. active surveillance and contact tracing (enhanced surveillance) through community-based mobile teams active case finding (screening and triage) and contact tracing dedicated isolation facility food provision to isolated patients so they are not dependent on family case definition treatment protocols emphasizing supportive care and treatment of complications essential drugs referral guidelines secondary prevention barrier nursing strictly enforced family and community education ministerial task force to address policy local health authority task force to address procedures national level task forces to comprise if a lab is not available, then you need a sampling strategy that addresses specimen acquisition, preparation, and transportation in compliance with international regulations on the transport of infectious substances. guidance note on using the cluster approach to strengthen humanitarian response international conference on primary health care selective primary health care-an interim strategy for disease control in developing countries water and excreta-related diseases: unitary environmental classification infections related to water and excreta: the health dimension of the decade world health organization. cholera vaccines: who position paper available from: international centre for diarrhoeal disease research history and epidemiology of global smallpox eradication available from: us department of health and human services communicable disease control in emergencies-a field manual. geneva: world health organization ebola: technical guidance documents for medical staff world health organization. manual for the care and management of patients in ebola care units/community care centers-interim emergency guidance. who/ evd/manual/ecu/ . . geneva: world health organization what tests does it perform? is there transport to and from the laboratory? who prepares transport media? who provides specimen collection material and supplies? how can these supplies be obtained? who provides cool packs, transport boxes, car, driver …? • refrigerate other vials for cytology, chemistry ( °c) leak-proof specimen container wrapped with enough absorbent material to absorb the entire content of the st container . leak-proof secondary container usually plastic or metal . outer shipping container whose smallest dimension is mm diagnostic specimens use iata packing instruction without biohazard label. infectious materials use iata packing instruction with biohazard label. what to send with the sample? lab request form with: • sender's name and contact info • patient name, age, sex • sample date, time • suspected clinical diagnosis with main signs and symptoms • sample macroscopic description • context-outbreak confirmation, ongoing verification, outbreak end, etc • epidemiological or demographic data where to send the sample? • reference lab • contact person what and when to expect results? source: world health organization world health organization department of communicable disease surveillance and response. highlights of specimen collection in emergency situations. undated . designate a lead official in the lcc. . anticipate roles for partner agencies (eg inter-agency and team coordination, disease surveillance, field epidemiological investigation, laboratory identification, case management guideline development, outbreak logistics, public information, and social mobilization). . identify sources of funds. . intensify disease surveillance. . identify reference lab(s) for communicable diseases of epidemic potential. . ensure mechanism for specimen transport. a. initial response to suspected outbreak . form an emergency team to investigate and manage the outbreak a. identify key roles on the outbreak investigation team(s) ( ) epidemiology and surveillance ( ) case management ( ) water and sanitation ( ) laboratory services ( ) communication b. staff those roles ( ) epidemiologist-to monitor proper data collection and surveillance procedures ( ) physician-to confirm clinical s/sx and train health workers in case management ( ) water and sanitation expert-to develop a plan for reducing sources of contamination ( ) microbiologist-to take environmental/biological samples for laboratory confirmation, train health workers in proper sampling techniques, and confirm use of appropriate methods in the diagnostic laboratory ( ) key: cord- -b r authors: labrunda, michelle; amin, naushad title: the emerging threat of ebola date: - - journal: global health security doi: . / - - - - _ sha: doc_id: cord_uid: b r ebola is one of the deadliest infectious disease of the modern era. over % of those infected die. prior to , the disease was unknown. no one knows exactly where it came from, but it is postulated that a mutation in an animal virus allowed it to jump species and infect humans. in simultaneous outbreaks of ebola occurred in what is now south sudan and the democratic republic of the congo (drc). for years, only sporadic cases were seen, but in a new outbreak occurred killing hundreds in the drc. since that time the frequency of these outbreaks has been increasing. it is uncertain why this is occurring, but many associate it with increasing human encroachment into forested areas bringing people and animals into more intimate contact and increased mobility of previously remote population. this chapter will navigate ebola in the context of global health and security. there are multiple objectives of this chapter. first is to provide a basic understanding of ebola disease processes and outbreak patterns. second, is to explore the interplay between social determinants of health and ebola. the role of technology in spreading ebola outbreaks will be explained as will ebola’s potential as a bioweapon. readers will gain understanding of the link between environmental degradation and ebola outbreaks. this chapter will be divided into five main sections. these are ( ) a case study; ( ) ebola disease process; ( ) social determinants of health and ebola; ( ) ebola in the modern era, and ( ) the link between ebola and environmental degradation. who contracts ebola. the story will be told from her perspective. she will describe from her why she thinks the outbreak has occurred. her husband has died of ebola despite efforts of traditional healers. she will discuss burial rites in the context of her religious beliefs. the next section looks at the disease itself. the history, epidemiology, transmission, and signs/symptoms will be described. prevention measures including the use of personal protective equipment and vaccination strategies will be discussed. the basics of diagnosis and treatment will be covered. the section will end with a discussion of ebola epidemics. social determents of health play an important role in the epidemiology and transmission of ebola. factors impacting spread include, high population mobility, porous international borders, and ongoing conflict resulting in displaced populations. poverty, cultural beliefs and practices and prior ineffective public health messages have all played a role in the emergence of ebola. the following section will explore ebola in the era of technology. the role of air travel in disease spread and the effectiveness of airport screening measures will be discussed. ebola's potential for use in bioterrorism will also be discussed in this section. the relationship between environmental encroachment and disease emergence will be explored. global warming, and the impact of a growing population in ebola outbreaks will be explored. the chapter will end with a discussion of future directions. in this last section the important of international collaborations for disease prevention and public education programs will be discussed. sia waited nervously in the small one room house where she lives. she was waiting for her brother-in-law to return with the body of her dead husband, saa. he had died yesterday of the bush illness that was killing so many in her community, ebola the outsiders called it. just weeks ago, the world had seemed a different place. sia had sat with the other women of the kissi tribe at church joking and planning for the upcoming rice harvest. yes, they practiced christianity, but also followed the traditions of their ancestors. women in her village prayed to jesus and god, but also to their ancestors. outsiders sometimes questioned how the kissi could follow both christianity and their old traditions, but sia had never seen a problem. ancestors after all, were the ones who communicated with god. when someone in the family died, they were escorted to the realm of the ancestors where they were able to protect the living family and speak to god on their behalf. ancestors continued to live in the village, but in their new form. sia shivered thinking of what happened to those who died and were not escorted to the realm of the ancestors. ceremonies were usually performed by the brother of the deceased. if the ceremonies were not done properly, a loved one would become a wandering ghost instead of an ancestor. wandering ghosts torment the living bringing misfortune to everyone in the village, especially to the family that failed to perform the proper rights. sia did not like to think of such things, but there had been several deaths in a nearby village and she could not help but to wonder if it was the work of a wandering ghost. that was the day it started. saa was fine when he woke up, but while they were at the church, he started to get sick. he got sick so quickly that sia suggested that they return home early so he could rest. it wasn't a far walk, but by the time they arrived home, saa was having chills, headache, nausea, and said his joints hurt. while saa rested, sia prepared a tonic to ease the pain and ward off evil spirits. saa's eyes were red and he felt hot to touch. "a powerful spirit must be involved", sia thought to herself. she couldn't imagine who would have cursed her husband this way. he hadn't argued with anyone that she knew. for days sia cared for her husband with special food, potions, and prayers. she had even sacrificed a chicken, but instead of getting better he started vomiting and having diarrhea. obviously, she needed assistance from someone with greater influence in the spirit realm. kai, a local medicine-man of conservable powerful agreed to help but needed time to make the necessary preparations. by that evening saa had stopped eating altogether and his gums started to bleed. kai belonged to a secret society that added to his powers. sia was not allowed to attend kai's ceremony but was told that saa had cried blood and started to hiccough uncontrollably. kai was notable to defeat the evil spirits even with his most powerful incantations. some of the villagers wanted to take saa to a treatment center set up by some foreigners to see if they could help him. sia was hesitant, but by the next morning saa had developed a yellow color to his skin and was having black diarrhea, so she agreed. after a bunch of questions saa was taken into the camp that the foreigners set up, but they would not let sia or anyone else in the family enter. that was the last time she had seen saa alive. two days later sia was informed that saa had died. he was to be buried in a mass grave and no one was allowed to see his body. saa's brother said that he thinks the foreigners killed him. they weren't really there to help but part of a government plan to destroy the kissi. workers in the camp were removing the internal organs of the sick while they were still alive and selling them. that is why no one was allowed into the camp or to bury the bodies properly. they weren't just attacking the living, but also trying to destroy the ancestors by preventing the death ceremony from happening. luckily saa's brother knew people. it had cost everything that the family owned, but the man driving the truck full of bodies agreed to meet a short distance from the foreigners' camp. he would give them the body there, but there were not to tell anyone. as saa's brother walked into the house carrying saa's body, sia felt an overwhelming sense of relief. all the worry gave her a headache and made her feel weak. now that they had saa's body it will be better. they will do the rituals this evening and burry saa in the morning. he will be able to walk with the ancestors. one of the world's deadliest pathogen, the ebola virus made its first appearance in in not just one but two simultaneous outbreaks. the first of its deadly attacks were in what is now known as nzara, south sudan while the second occurred in a small village community near the ebola river bank in yambuku, democratic republic of congo (drc) [ ] . of the known to be infected, lost their lives. since that time, we have learned much about the ebola virus and the disease it causes. ebola virus is an uncommon virus which infects both human and non-human primates. it belongs to the family filoviridae, a negative stranded rna virus. when magnified, it appears as a filamentous structure fig. . the ebolavirus genus has six known species, zaire, sudan, tai forest (formerly côte d'ivoire ebolavirus), bundibugyo, reston, and the recently described bombali [ ] . reston is highly pathogenic for non-human primates and pigs, and bombali has been discovered in free-tailed bats as part of ongoing research to discover the ebola reservoir. the zaire species was responsible for the first ebola virus outbreak in and is considered to be the deadliest of the six [ ] . initially the disease caused by ebola virus was called ebola hemorrhagic fever, but later studies showed that the hemorrhagic manifestations were less common than initially thought and subsequently the name was changed to ebola virus disease (ebd). until , the ebola virus isolated sporadic outbreaks occurred only in central africa with counts numbering in the hundreds or less, and only lasting days to weeks. however, in march the who confirmed an epidemic of the zaire species of ebola virus emerging in west africa. this outbreak lasted years and grew to be one of the world's deadliest epidemics. there were , case and , fatalities documented by the world health organization (who). the index case of this epidemic is thought to be a -year-old child who became ill in late . the child eventually succumbed to the illness with symptoms of fever, chills, vomiting, and black-tarry stool [ ] . this was in guinea, west africa a country where ebola supposedly did not exist. from here it spread to liberia, sierra leone, nigeria, and mali. the natural reservoir of ebola virus is not known with certainty, although research has suggested that it may be bats. human infection may occur through direct contact with the mystery reservoir or through contact with infected primates. this can occur when hunting and preparing bush-meat or via contact with body fluids from an infected person. ebola is highly transmissible. the disease pattern of evd has shifted over the last years. currently, ebola has been found across central and west africa, with occasional exported cases to other regions. for obscure reasons, outbreaks seem to be occurring with increasing frequency. this may be linked to environmental degradation and increasing mobility of local populations. ebola spread is through contaminated body fluids. unfortunatly, traditional funerary practices across africa put funeral attendees in contact with body fluids from those who have died of ebola. initial international efforts to control ebola spread during outbreaks have often resulted in clashes and conflict as control measures confront tradition. inadequate public health messages, distrust of those providing the health messages, political instability, and regional conflict have allowed ebola to spread and kill thousands when early containment could have been within reach. ebola is one of the most fatal infectious diseases humans have encountered. even with the best medical care the disease is deadly. unfortunatly, the developing countries where evd occurs are not equipped with optimal medical or public health facilities. to complicate the situation further, survivors of evd are not hailed as heroes, but instead may be left with chronic illness and stigmatized in their communities. transmission of ebola disease is still being studied, but it is known that person-toperson contact is the most common form of spread. infection occurs primarily through direct contact with body fluids from infected people or animals (fig. ). viral antigens have been isolated from the skin of those infected suggesting that skin contact alone may be sufficient to spread disease [ ] . it has also been shown that, at least in primates, ebola can be spread through intramuscular injection, and inoculation can occur through contact of the conjunctiva or oral mucosa with infected body fluids [ ] . blood, vomitus, and feces are the body fluid most likely to spread infection because of the frequency with which they are encountered during the course of the illness, but other fluid such as urine, semen, vaginal fluid, tears, sweat, and breast milk also have potential for viral transmission [ , , , , , ] . caring for an infected person with ebola, whether at home or in the hospital has been identified as a high-risk activity for acquiring ebola. household members who provide direct care to an ebola victim are - times more likely to contract ebola than household members who share a residence but do not participate in patient care [ , ] . healthcare workers are also at high risk for acquiring ebola. one study found the risk of developing evd for healthcare workers to be times that of the general community during an outbreak of ebola in sierra leone [ ] . there are many factors contributing to the spread of ebola amongst healthcare workers. the presentation of ebola is non-specific so early on in the disease process it may be diagnosed as malaria, influenza, or other non-specific viral illness. if a patient is initially misdiagnosed, then proper protective measures to limit the spread of ebola will not be initiated. also, the use of personal protective equipment (ppe) including gloves and gowns for routine patient care is less common in developing countries than in more developed countries due to financial restriction. there is a risk of iatrogenic spread of ebola. in the initial outbreak of , health care workers reusing glass syringes and needles in a community clinic may have inadvertently caused spread of infection. the facility consisted of a -bed hospital and a busy outpatient center which treated between and , people per month. at the beginning of each day, nurses were given five syringes each which were reused after a warm water rinse. unfortunatly, this is where ebola made its first appearance. potentially hundreds were exposed from this clinic alone [ , ] . there have been many other instances where hospitals have turned into epicenters for ebola outbreaks [ , ] . early detection and isolation is key to preventing similar incidents in the future. the greatest risk of transmission of evd from human to human occurs when a patient is acutely ill. risk also corelates with severity of illness. the sicker a patient is the more infective she is. in early phase of acute illness, the viral load is relatively low, however it increases exponentially during the latter part of the acute illness, and high viral loads are associated with high mortality rates and infectivity [ ] . those who handle corpses of ebola victims after death also run considerable risk of acquiring the disease. many funerary customs in ebola-prone regions involve extensive physical contact with the dead body. despite the risk of transmission, many still engage in these traditional practices. without these preparations, some local traditions hold that misfortune will plague the living and the dead will not be able to pass into the spirit realm. family who do not engage in expected funerary practice may be viewed negatively in the communities where they live. one funeral ceremony alone has been linked to additional cases of ebola [ ] . transmissibility of ebola virus depends on the phase of infection of the ill-person. the viral load corresponds to the severity of illness [ ] . in other words, the sicker a person is, the higher concentration the concentration viral particles in the blood stream. as an ill person succumbs to ebola, they become more debilitated and require more care. at the same time, the viral load increases as the victim declines. because of this, family caring for the ill are more likely to be infected in the later stages and corpses of those killed by ebola are highly infectious [ ] . even after a person has recovered from ebola and no virus can be isolated from blood, it may still be found in other tissues and able to transmit disease. live virus has been isolated from breastmilk after recovery raising the issue of transmission to mother to infant [ ] . ebola has been isolated from semen up to months after onset of symptoms, in urine for days, sweat for days, aqueous humor of the eye for weeks, and in cerebral spinal fluid for months [ , , , , ] . there has been at least one case where a man who recovered from ebola transmitted the infection to a sexual partner days after his initial illness [ ] . to prevent sexual transmission of ebola, the who recommends systematic testing for ebola virus in semen. for the first months after infection, the semen of male ebola survivors should be assumed to be infectious. three months after the day symptoms started semen testing for ebola should be initiated. if the result is negative, then it should be repeated in week. if the test is positive, then it should be repeated monthly until a negative result is obtained. once two consecutive negative results have been obtained sexual activities can be resumed [ ] . vaginal secretions have been found to contain virus up to days after the initiation of symptoms, but no official testing recommendations exist for vaginal secretions [ , ] . other methods of ebola spread have been postulated, but do not appear to be significant sources of transmission. surfaces contaminated with body fluids produce a theoretical risk of transmission, but no confirmed documented cases of fomite transmission of ebola exist. ebola virus has been shown to persist in the environment supporting the need for close attention to decontamination of surfaces [ , ] . medical procedures can augment disease spread if proper precautions are not taken [ ] . hunting and capturing infected animals for bush meat or for trading in black market as exotic pets can result in exposure and transmission of ebola. there have been numerous instances of human infection resulting from contact with dead primates [ , ] . contact with wild primates, especially those found dead should be avoided to curb the risk of contracting ebola. there is another step in ebola transmission that continues to be elusive. humans and other primates can catch ebola from each other, but they are not the reservoir. the reservoir is not known with certainty, but there is some evidence linking bats to ebola [ ] . the evidence for bats as the ebola reservoir is suggestive but not compelling. antibodies against ebola have been found in bat species, but the significance of this is unclear. antibodies are formed when an organism has been exposed to an infectious organism. this is evidence of exposure and immune response, but not of long-term infection or viral shedding [ ] . only one small study has ever isolated ebola rna from bats [ ] . attempts to infect bats then isolate viral rna or shedding have not met with success [ , ] . as the systematic search for the reservoir continues, negative findings are as important as positive one. plants and arthropods have not been shown to harbor ebola [ , ] . ebola virus disease is an acute febrile illness that has been associated with hemorrhagic manifestations. it has an incubation period of - days, but presentation of symptoms is most common between day and after exposure [ ] . it is unclear whether or not infected people can transmit disease prior to developing symptoms, but those with symptoms should be assumed to be contagious. evd typically begins with abrupt onset of malaise, fever, and chills. it is also common to experience vomiting, headache, diarrhea, and loss of appetite early in the disease course. the diarrhea can be profuse and water losses of up to l per day have been reported [ ] . dehydration and hypovolemic can result. relative bradycardia can also be seen in ebola [ ] . a maculopapular rash commonly develops - days after onset of illness. the rash is not a consistent finding and seems to vary from region to region [ ] . hemorrhage is the most dramatic symptom associated with evd but is not as common as first feared. usually it manifests as gastrointestinal bleeding, but petechia, ecchymosis, bleeding oral mucosa can also be seen [ ] . bleeding is multifactorial and likely due to a combination of thrombocytopenia, coagulopathy from liver involvement, and in some instance disseminated intravascular coagulation (dic). evd can cause involve a number of different organ systems. neurologically, it can cause meningoencephalitis, confusion, chronic cognitive decline, and seizures. neurological symptoms typically occur - days after onset of illness [ , ] . cardiomyopathy and respiratory muscle fatigue have been described [ ] . eye involvement is also common early in the disease course and may persist. patients frequently report blurred vision, photophobia and blindness [ ] . laboratory findings during the course of the infection can include leukopenia, elevated renal profile, abnormal coagulation panel, thrombocytopenia, anemia, and elevated liver function tests [ ] . hiccoughs are common late in the acute phase of illness. symptoms typically abate after weeks of illness. even after the acute illness has resolved, ebola victims can have long term symptoms. these include fatigue, insomnia, headaches, myalgias, arthralgias, cognitive decline, and hair loss. uveitis and hearing loss are both common after recovery from evd [ , ] . even after the resolution of acute evd, new symptoms can develop. in a study looking at early clinical sequela, % of ebola survivors developed arthralgias, % ocular symptoms, % auditory symptoms, and % uveitis [ ] . studies evaluating the long -erm sequela of evd are ongoing. prevention strategies for ebola are numerous, but essentially boils down to avoiding all contact with skin and body fluids that could potentially harbor the ebola virus. of course, this is more easily said than done especially in health care settings, and for families of those infected. health care providers deal with rapidly changing conditions often in limited resource settings and are at high risk for contracting ebola if prevention protocols are not followed. families of ebola victims face similar, but even more daunting challenges. ebola may be found in secretions of those who have recovered for months or even years after the acute illness has resolved. while not common, cases of transmission have occurred months after a person has recovered. active ebola virus can persist in urine, vaginal secretions, breast milk, semen, ocular fluid, and cerebrospinal fluid even after recovery making prevention more challenging. while not heavily researched as an effective prevention strategy, people who eat bushmeat should be encouraged to take precautions to prevent ebola infection. this means avoiding contact with fluids from slaughtered animals as much as possible. ebola virus is inactivated by thorough cooking, so through cooking of bush meat should be encouraged [ ]. ebola is highly pathogenic and easily transmitted. both the who and the center for disease control (cdc) have published detailed guidelines on prevention which are freely available online [ , , ] . the who recommends the following key elements to prevent transmission of ebola virus in the hospital setting: • hand hygiene • gloves • facial protection (covering eyes, nose and mouth) • gowns (or overalls) • sharps safety • respiratory hygiene for both health care providers and patients • environmental cleaning • safe linen transport and cleaning • proper waste disposal • proper sanitation of patient care equipment ebola prevention requires attention to and special training in donning and removing personal protective equipment (ppe). specific instructions and videos for use of this equipment is available at the who prevention cdc websites. health care workers who use ppe equipment properly are safe from ebola infection, but can develop other health issues from the ppe itself. the ppe suits are hot, uncomfortable, and require constant surveillance to ensure that all the equipment remains in place and undamaged. areas prone to ebola outbreaks tend to be hot, humid, and lack resources for air conditioning, wearing ebola suits creates a risk for development of heat related illness and dehydration. the cdc has published guidelines for preventing heat related illness for those providing care to ebola patients in hot african climates [ ] . as previously mentioned, people have survived initial ebola infection may still be able to transmit the disease to others. with proper preventive measures the risk of transmission can be ameliorated. as with other aspects of ebola, both the cdc and who have published extensive guidelines available on their websites. for healthcare workers, no special precautions are needed for basic patient care. the cdc does recommend that additional ppe be used when caring for ebola survivors if contact with testes, urine, breast, breast milk, spinal fluid, or intraocular fluid is anticipated during patient care [ ] . in the home, additional precautions may be needed. cases of transmission through sexual contact and breast milk have been describe in the literature [ , ] . cdc guidelines recommend abstinence from sexual activity of all types including oral, anal, and vaginal. if abstinence is not possible then condoms and avoidance of contact with semen is recommended. the who has recommended that semen be tested months after the onset of disease in men. if the test is negative, then it should be repeated in week. after two negative test sexual activity can be resumed. if the test is positive, it should be repeated every month until a negative test is obtained. once a negative test occurs, it should be repeated in week, and after two negatives sexual activity can be resumed [ ] . maternity issues around ebola are complex. it is unclear when it is safe for a woman to become pregnant after recovering from ebola. some organizations have suggested that a woman wait a few months prior to becoming pregnant, but so far this recommendation has not been supported by clinical data. breastmilk can transmit ebola virus from a mother who has recovered from evd to her child. if feasible, breastfeeding should be avoided. the data on ebola transmission through breasting is limited, and resources in ebola-prone areas make repeat testing of breastmilk impractical. suggested strategies have recommended avoiding breasting feeding for months after recovery [ ] . travel restrictions may occur during ebola outbreaks. it is generally accepted practice that those who have potentially been exposed to ebola virus not travel for days after the last possible day of their exposure. as an alternative for those at low risk, close monitoring with no restrictions on travel may be done. balancing individual rights with community safety creates ethical and regulatory challenges in cases of potential exposure. additional information on monitoring and travel restriction can be found at both the cdc and who websites. vaccination development is in place, but there is currently no federal drug administration (fda) approved vaccination for ebola. currently, there are different clinical trials running with the goal of developing a safe and effective ebola vaccine [ ] . an investigational vaccine called rvsv-zebov is presently being used in drc under "compassionate use". this vaccine is specific for the zaire strain of ebolavirus. this same vaccine was previously administered to , volunteers during an outbreak in . so far, the vaccine appears safe with few side effects, but insufficient data is available for licensing [ ] . preliminary reports suggest an efficacy of %, but duration of protection is currently not known [ ] . even though there are no specific therapies to treat ebola, diagnosis is important to prevent spread and to ensure administration of appropriate supportive care and monitoring. anyone who has had any potential exposure to ebola in the last days should be evaluated if symptoms of ebola develop. while awaiting the result of ebola testing, appropriate infection control practices should be implemented. diagnosis is done by reverse-transcription polymerase chain reaction (rt-pcr). the test should be done days after the onset of symptoms [ ] . false negatives can occur if the lab is collected before h of symptom onset. a positive test confirms ebola virus disease and that the patient is infective. considering repeat testing in patients whose clinical picture is highly suspicious of ebd and have a negative initial test. ebola virus disease has a broad differential, and simultaneous testing for other illnesses should be undertaken as clinically warranted. this differential includes, malaria, lassa fever, typhoid fever, influenza, meningococcal meningitis (neisseria meningitidis), measles, crimean-congo hemorrhagic fever, yellow fever, marburg, and the familiar travelers' diarrhea among many others [ ] . supportive care is the only treatment for ebola. there are no antimicrobial agents proven to be effective in ebd. when possible, care should be provided at a facility familiar with the clinical progression of ebola. supportive care in ebola is no different than for any other critically ill patient. give intravenous fluids to prevent dehydration and shock. patients with ebola suffer from vomiting and diarrhea and may easily dehydrate. if intravenous fluids are unavailable or prohibitively expensive, oral hydration should be undertaken. ebola can lead not only to hypovolemic shock, but also septic shock [ ] so close patient monitoring is warranted. electrolytes will require close monitoring and should be repleted as needed. vasopressors may be required if blood pressure cannot be maintained. ebola can result in significant hematological abnormalities [ , ] . it can also lead to liver failure followed by coagulopathy [ ] . thrombocytopenia, leukopenia, and anemia are all common and treatment should be based on the specific abnormality encountered. other management may include antipyretics, respiratory support, analgesics, antimotility agents for diarrhea, antiemetics for nausea and vomiting, antibiotics, nutritional support and renal replacement therapy. these and other supportive measures must be tailored to the individual patient need. the first reported outbreak of ebola-like illness occurred in in sudan and zaire [ ] [now south sudan and the democratic republic of congo (drc)]. it is probable that sporadic outbreaks happened earlier but were not identified. outbreaks appear to be occurring more frequently than before. this is not only due to improved detection techniques, but also due to environmental encroachment, increasing population mobility, and changing weather patterns. the following section will summarize data on known ebola social determinants of health are the conditions in which a person lives and grows. there is no one list of these factors, but they are generally considered to include influences such as school, (un)employment, the community where one resides, food, and transportation. the factors are driven by forces outside of one's sphere of control such as poverty and war as well as some potentially self-directed choices such as belief system and friend circle. for example, social determinants of health are a way of describing why when a . magnitude earthquake hits haiti buildings collapse and people die and when a . magnitude earthquake and the same earthquake on guam causes no damage. social determinants of health significantly affected how ebola has impacted affected countries. poverty affects every aspect of life for most. according to world bank data, the rate of poverty in sub-sahara africa is trending downwards but is still over % of the population. poverty leads to lack of education, limited medical resources, poor nutrition, and crowded living conditions. people in poverty will eat a dead animal if they find one because it may be all they have to eat. they are unlikely to seek medical care outside of traditional healers because it is all they know and can afford. they may insist on washing the bodies of the dead because their only knowledge of science are traditions passed from generation to generation. all of which contributes to the spread of ebola. anyone who reads the history the countries that make up the peri-equatorial regional of africa will quickly notice that the region has suffered from nearly continuous war since even before the european occupation. there are pockets of stability in the region, but conflict is a way of life for many. conflict leads to destruction of infrastructure, fear, stress, distrust, and population displacement. currently, an ebola outbreak is occurring in drc. refugees from drc continually flee into neighboring countries, especially uganda. conflict driven human movement is a means by which ebola can be spread. no widespread outbreak of ebola has occurred in a refugee camp, but these types of settlements are fertile soil where an outbreak could start and flourish before an alarm is raised. the ugandan government is working with the international federation of the red cross and red crescent societies (ifrc), unicef, and the who collaborating to develop an ebola emergency preparedness plan [ ] . political and economic instability across have resulted in a debilitated medical and public health infrastructure. official data is limited, but media sources have reported that liberia has experienced a severe shortage of trained health workers within the country. media sources list general practitioners, public health specialists, pediatricians, surgeons, obstetrician-gynecologists, ophthalmologists, internists, dentists, psychiatrists, family medicine specialists, orthopedic surgeons, radiologists, pathologist, ear-nose-throat specialist, veterinarian, and dermatologist as comprising the entire formally trained health community (excluding nursing professionals) [ ] . the cia world factbook lists the number of physicians per people to be . for liberia, . for sierra leona, . for guinea, . in drc, and . in uganda [ ] . even some of these numbers are almost years-old making it difficult to assess the actual situation in the region. regardless, it is a safe conclusion that none of these countries are even close to having the recommended physician per residents recommended by the who. each of these countries is unique in the health care challenges it faces, and only are mentioned here because they have all been touched by ebola. infrastructure development is generally associated with improved health and decreased disease burden, but this is not always the case. while lack of infrastructure such as water and sanitation is thought to lead to increased transmission. increased connectivity via road and boat is thought to increase the risk of transmission through increased number of contacts [ ] . one of the most fascinating aspects of ebola occurs at the intersection of culture and public health. for generations, a mixture of traditional beliefs and mainstream religion has served as a cultural foundation in many tribal areas across central and western africa. funerary practices in these tribes are some of the most important in their belief system. it is these practices that have been exploited by the ebola virus allowing it to spread. exposure has been associated with attendance of funerals and contact with dead bodies in multiple countries [ , , ] . as public health and medical personnel tried to curb ebola spread, conflict has occurred. those most at risk for ebola suddenly felt threatened not only by the disease itself, but also by those where were trying to help as their core beliefs were suddenly targeted. from the perspective of the health care workers trying to save lives, the cultural beliefs were generally considered as just another barrier to be surmounted. this lack of understanding between those at risk and the health care workers lead to conflict, distrust, which at times drove ebola victims into hiding rather than seeking care. bribes were made, bodies were stolen, aid workers were attacked, and ebola spread. some of the cultural beliefs common in central and western africa will be discussed here with the goal of fostering cultural understanding of disease. given the diversity of human beliefs, it is likely that future events will again put disease control against traditional beliefs. a good starting point in cultural sensitivity is viewing an idea from the point-ofview of the other party. in the case of ebola, it is important to understand what different groups of people believe to be the etiology of disease. most educated health professionals view disease as an understandable biological process. infections are caused by microbes. in the case of ebola, it is a filovirus. in many traditional african cultures, disease is believed to be due to witchcraft [ ] . consultation with traditional healers is a common practice across africa. in many regions traditional healers are the only locally available medical provider. even if modern medical facilities exist, many will turn to the traditional healers first because they are more trusted, and their beliefs tend to align more closely with those of the community. there are many different traditional healing practices, sometimes traditions are passed down through generations in specific families. one description of a traditional medical ceremony in sudan describes a medicine man and his assistants. first, ritualistic dance and chants are performed. next the medicine man shows his spiritual power by having a large rock placed on his abdomen and broken by an ax while he remains still. once his strength has been established, his attention can be turned to his patient. the medicine man's diagnosis is mental illness caused by evil ancestors who have returned with the purpose of tormenting the patient. incantations are the treatment [ ] . beliefs and practices such as this are common in rural central africa. in these societies, illness is viewed as a disruption in the relationship between god, ancestors, and the person affected. witchcraft, sorcery, angry ancestors, and evil spirits may all be at the root of disease and a powerful medicine man can restore the proper balance in these relationships thus curing disease [ , ] . the individual customs and beliefs associated with the cause and treatment of disease is too long to be included here, but those interested in additional information should read the articles cited in this section for additional details. traditional healers can be a great asset to a community, but there have been unfortunate instances where they actually promoted the spread of ebola. some traditional healers claimed to be able to cure ebola. unfortunatly, their attempts at cure have been known to spread the disease to those in attendance of curative ceremonies as well as to themselves [ ] . traditional healers can also charge a significant amount of money putting a family who is already dealing with the loss of a loved one in additional financial stress [ ] . not all traditional healers seek the good of the community but instead are motivated by personal gain. many societies in central africa practice religious beliefs based on a combination of mainstream religion and ancestor worship. occult ceremonies, secret societies, and rituals are common, and the details of these practices are often covert, only known to a small subpopulation. the ceremonies may be benign such as the one described in the preceding paragraph or may involve animal or human sacrifice [ , ] . while many of these practices involve sacrifice and exposure to blood no studies have been published linking these activities to ebola transmission. it is the traditional funerary practices that have been most closely associated with the spread of ebola. many central and western african cultures view the death ceremony as one of the most important. when people die, they must be guided to the realm of the ancestors. from this realm, ancestors are able to hear the requests and see the needs of the living family and communicate these needs to god. the living family prays directly to the ancestors. if death rights are not done correctly then instead of becoming an ancestor, the deceased may become an angry ghost which torments the family [ ] . a common funerary practice in liberia is for an elder family member to bathe the body of the deceased. it is common for mourners to touch the face and kiss the forehead of the deceased. in some traditions the spouse of the deceased continues to share a bed with the corpse until the time of burial. another tradition involves dance. on the night prior to the funeral, men dance with the dead body while women wail. several traditions involve sacrifice and exposure to the blood of a bull as part of their ceremony [ ] . to prevent the spread of disease the governments in liberia and guinea passed laws requiring safe burial teams or cremation when the number of grave sites was insufficient for the number of bodies. numerous reports of bribing health workers responsible for collecting and properly disposing of the bodies allowed ebola to persist in this region [ ] . people stopped going to the health care facilities, and families would try to hide the cause of death from officials. at the height of the epidemic in sierra leone, the number of ebola care beds was insufficient for the number of patients. many were transferred from facility to facility and their families were not notified. rumors began to spread that the ebola facilities were harvesting organs and killing people [ ] . poor communication resulted in suspicion and distrust. it took thousands of deaths, but finally both sides began to compromise. the government and health care workers started to work with local religious leaders and traditional healers to find solutions that would let the people honor the dead without exposing themselves. many muslim leaders told their followers to abstain from washing bodies until the outbreak ended. bodies were buried with families nearby and although the could not touch the bodies prayers could be said. burial teams started to dress corpses in clothing requested by the family and often placed requested jewelry. once all sides compromised and started working together the epidemic was able to be contained [ ] . even if someone survives ebola the battle is not over. there is poor understanding of disease and disease transmission. survivors may be ostracized and shunned by their communities because there is fear that they can spread disease. survivors have had their houses burned, families attacked, and lost their jobs due to irrational community fear. during the west african ebola outbreak survivors were issued certificates stating that they were no longer contagious in an attempt to combat social stigma. this is not to say that it is all gloom-and-doom in countries that have experienced ebola outbreaks. social determinants of health are not isolated static elements. technology and globalization are bringing health improvements at an unprecedented rate. if one reviews data for the countries where significant ebola outbreaks have occurred, guinea, uganda, drc, south sudan, and liberia. all of these countries have had a decrease in infant mortality rates, decrease in maternal mortality rates, and extreme poverty rate have been steadily dropping over the last years despite the presence of ebola [ ] . anyone interested in additional information on measurable global trends, whether they be economic, or health based is encouraged to visit gapminder (www.gapminder.org). not every country that faces ebola descends into a public health crisis. in july multiple cases of evd were diagnosed in lagos, nigeria. lagos is a densely populated city and the capital of nigeria. the nigerian ministry of health was able to rapidly contain the situation before a full-scale epidemic began. the nigerian government had access to trained health care providers able to do contact tracing, able to mobilize a rapid efficient response, and worked closely in cooperation with the who to implement standardized epidemiologic practices. the epidemic in nigeria was halted before it was able to start [ ] . ebola in the technology era the concept of quarantine was first developed in the fourteenth century to control the spread of plague [ ] . quarantine is a required separation of incoming people or animals prior to mixing with the local population with the goal of preventing the spread of disease. it is one of the oldest and most effective public health measures, but very unpopular with those whose movements are restricted by quarantine. recently, kaci hickcox, a nurse volunteering in sierra leone returned to the us. she possibly had been exposed to the ebola virus. ms. hickcox was placed on a mandatory home quarantine of days, but she defied the quarantine order and proceeded with her day-to-day activities [ ] . in reality, she was at very low risk for developing the disease, and there was essentially no risk for widespread ebola transmission in the us, but her unwillingness to comply with the quarantine brought attention to many public issues surrounding quarantine. specifically, the conflict between individual civil liberty and the well-being of the general public [ ] . since when quarantine laws were first written technology has expanded drastically. surely there exists a technology that allows us to abolish the antiquated quarantine system. whether an intentional act of terrorism or through accidental contagion spread, travelers pose a significant threat to homeland security. various measures have been attempted to try and identify sick travelers with the goal of limiting epidemic spread. the following is a discussion of currently available boarder control measures aimed at preventing the spread of disease, and evaluation of the effectiveness of these measures, and a discussion of technologies that may be of utility in the future in preventing cross-border ebola spread. two-point-five million people fly in or out of the united states every day [ ] and an estimated one-million more per day cross via land and sea [ ] . with millions of border crossings daily, transmission of communicable disease between remote locations is inevitable. the vast majority of communicable diseases spread by travelers are upper respiratory viruses such as the common cold or influenza. generally, these are self-limited illnesses with few long-term consequences. every few years though, something new with greater lethality emerges and threatens the security of the us travelers, their contacts, and the broader population at home. ebola, severe acute respiratory syndrome (sars), and even the relatively benign zika virus have made media headlines with travelers seen as potential harbingers of disease. another factor that must be taken into account is the increasing population density and urbanization. the united nations (un) predicts that % of all people will live in cities by the year [ ] . a megacity is defined as an urban population of over ten million people. the first to reach megacity status was new york city in the 's [ ] . by , the megacity count rose to [ ] . large numbers of people in a small area constitute a vulnerability when looking at epidemic risk assessment. a single ill traveler arriving to a megacity has the potential to start a local chain of infection that could rapidly spread to millions. with the widespread availability and affordability of trains, planes, automobiles, buses, and boats it is easy for microbes as well as humans to travel rapidly across the globe. travel provides individual freedom for pleasure and commerce but, at the expense of national security. small disease outbreaks are continually occurring across the globe. multiple international monitoring systems are in effect and the center for disease control (cdc) has issued official recommendations for travel restrictions for persons with higher-risk exposure to communicable diseases of public health concern [ ] . briefly, these guidelines state that a person who meets the following criteria will have their travel restricted [ ] : be known or likely infectious with, or exposed to, a communicable disease that poses a public health threat and meet one of the following three criteria: . be unaware of diagnosis, noncompliant with public health recommendations, or unable to be located. or . be at risk for traveling on a commercial flight, or internationally by any means. or . travel restrictions are warranted to respond effectively to a communicable disease outbreak or to enforce a federal or local public health order. while the above criteria may be the best legally available option, it leaves a multitude of holes by which a person with a communicable illness could slip into a us city and start a new epidemic. ideally, additional layers of protection would allow potentially ill travelers to be identified and detained prior to entry to the united states. an infectious agent can travel across the globe in h if spread via airplanes [ ] . this has important implications for those trying to prevent disease from spreading. land and boat entry into the united states present other challenges. the sheer number of people crossing by land on a daily basis makes any screening difficult. boat traffic can also present unique screening challenges. a cruise boat, for example, may arrive with thousands of people who all debark within a short period of time. though screens are impractical in these situations. even if screening technology was employed allowing security agents to detect fever there are so many causes of fever that timely interpretation of the data would be difficult. with so much international travel occurring, there is a continual search for ways to improve screening for ill travelers with the goal of preventing importation of disease. many different methods have been tried, most centered around a specific pandemic rather than continual monitoring. none have had great success. these methods have included entry-screens, exit-screens, and post-entry monitoring. the us division of quarantine is not only authorized, but required to identify and detain anyone entering the country with actual or suspected diphtheria, any viral hemorrhagic fever including ebola, cholera, tuberculosis, small pox, plague, novel influenza strains or yellow fever [ , , ] . in theory, this is an excellent regulation, but how can millions of travelers be efficiently screened and detained if needed? after the outbreak of sars in many countries starting using boarder screening to try to identify possibly ill people in hopes of limiting spread of infectious disease, others jumped on board after the h n influenza pandemic. the issue then resurged in the wake of the ebola outbreak in west africa. as with many things, there must be an understanding of the costs, potential benefits and effectiveness of programs aimed at preventing a possible public health disaster. an article by the cdc, published around the same time as the article recommending travel restriction for high-risk individuals, concludes that border screens are expensive and not effective in preventing the spread of disease [ ] . while point-of-care screens are not yet considered an effective means of controlling certain biosecurity threats, progress is being made. temperature screens have been developed with the goal of identifying people with fever. what happens when a fever is detected depends on where a person is traveling to and from, and the current state of outbreaks occurring in the world. there are several types of temperature readers including ear gun thermometers, full body infrared scanners, and hand-held infrared thermometers [ ] . none of these methods is highly effective and most screening devices can be fooled with minimal training and effort. once study found that thermal screens were only about % effective in detecting fever. the authors of this study concluded that temperature screens were ineffective in identifying ill travelers [ ] . the european center for disease control (ecdc) has also investigated the feasibility of using temperature screens to identify ill travelers and came to similar conclusions. this report was done during the ebola of and geared towards diagnosing travelers potentially infected with ebola. they estimate that even under ideal conditions % of symptomatic illness would be missed due to low sensitive of temperature devices [ ] . additionally, it was concluded that those intentionally trying to mask their temperature could easily do so and that those who had not developed symptoms would be missed by the screen. even if fevers screens were accurate and difficult to manipulate that would still be a poor screening measure. first of all, with many illnesses including chicken pox, flu, the common cold and countless others, people can be contagious before a fever starts. it is not yet known if an infected person can spread ebola before symptoms begin. secondly, not all fevers indicate an infectious disease. fevers can be due to drug reactions, blood clots, and even cancer. third, not everyone reacts to an infection the same way. some people naturally tend to have fever and others tend not to. one expression commonly taught in medical schools across the us is, "the older the colder". this is a reminder to students that elderly patients may never have a fever even if they are extremely ill with an infectious disease. lastly, what determines what constitutes a fever? the medical field defines fever as a temperature of degrees celsius ( . f) or higher. are these same numbers valid for travelers or should different cut offs be used? while temperature screens may have their place in emergency settings, they are far from an ideal way of detecting an ill passenger and the day to day use of temperature screens is not generally considered an effective means of identifying ill travelers. when foreign agencies are cooperative screening may be done prior to departure. exit screening was done during the ebola outbreak of for travels from west africa to the united states. the goal of exit screening is to identify those potentially infected with a specific disease and prevent them from departing for the united states until they can be medically cleared. the cdc considers this to be one of the more effective forms of preventing disease importation to the united states [ ] . departure screens are not routinely used except during times of known outbreaks. during the west african ebola outbreak exit screening measures were implemented. the general process used for screening during the outbreak was as follows. travelers were instructed to arrive earlier than they normally would for their travel due to increased processing times. general instructions to travelers instructed them to postpone travel if they were ill. in addition to the regular airport screening, all travelers were required to have their temperature taken and fill out a "traveler public health declaration". travelers who were febrile or considered at risk based on the answers to their health declaration forms were detained and their travel delayed [ ] . during the ebola outbreak the who provided resources for predeparture screening that were detailed yet used easy-to-follow language and including flow charts for those performing the screen. basic information on ebola and its symptoms so that the illness was more well understood and the disease symptoms familiar. directions for using personal protective equipment for those performing the screening. written tools and the public health declaration form were provided. additional resources included a data collection log and a traveler information card that could be distributed to travelers [ ] . the ebola screening was done in two steps, a primary screen and a secondary screen. the primary screen included three questions: ( ) is the traveler febrile?; ( ) is the traveler demonstrating symptoms of ebola?; and ( ) has the traveler marked "yes" to any questions on the health declaration form? an affirmative response to any of these questions resulted in secondary screening. secondary screening involved a public health interview and filling of the secondary health screen form, repeat temperature measurement preferably with an accurate thermometer, and focused medical exam. if the secondary screen found a temperature < . , no risk factors for ebola in the public health interview, and no symptoms of ebola on the public health interview they were allowed to proceed to check-in. if the above criteria were not met, check-in was denied until health clearance could be obtained [ ] . this strategy was considered effective. the limitations include the time and money required to implement the program, frustrating travel delays for travelers, and the inability to identify illnesses other than ebola or similar diseases. its usefulness is limited to known and identified epidemics. this strategy will likely continue to be used in future outbreaks to prevent exportation of disease [ ] . temperature screens have been used during five epidemics to date, dengue, sars, ebola, and influenza during both the entry and exit process. screening for fever in taiwan entry points during a dengue outbreak was reported to be effective. one research study reports that % of imported dengue cases were able to be identified through airport screening [ ] . during the sars outbreak, singapore entry points screened , people and identified no cases, canada entry points screened . million people and identified no cases, and hong kong entry points screened . million people identifying only two cases of sars [ ] . fever screening was used during the - influenza pandemic and even with a low threshold for defining fever was found to have a sensitivity in the . % range. exit screening done in west africa during the ebola outbreak identified fever in out of , travels screened. of these, none had ebola [ ] ). active monitoring is another technique that can be used in preventing disease spread within ebola naive countries such as the united states. it involves allowing a traveler freedom to come into the us, freedom from quarantine, but also allows health authorities to monitor the health status of potentially infected people. if someone begins to develop symptoms then measures can be taken to isolate, diagnose, and treat the ill person. this method is best applied to those who are reliable and at low risk for developing illness. there has not been much experience with widespread use of active monitoring systems with the exception of the western africa ebola outbreak. during this outbreak, travelers from liberia, sierra leone, and guinea to the us were given care (check and report ebola) kits upon arrival to the us [ ] . care kits provided resources to travelers from ebola affected countries. travelers were given information on the signs and symptoms of ebola, educated on the basic pathophysiology of ebola, provided a thermometer with detailed use instructions and given a cell phone to ease the communication process. travelers were allowed to travel freely but were required to check in with public health officials daily. during these check-ins, Àhealth reports were given including the development of any new symptoms, and daily temperature readings for days. ebola has a highly variable incubation period. twenty-one days was the longest interval between exposure and disease presentation to have been reported accounting for its use in both care packages and quarantine [ ] . while the cdc coordinated active monitoring programs, the programs were managed at the state level. all states eventually participated, but with varying start dates. new york, pennsylvania, maryland, virginia, new jersey, and georgia were those to first initiate the program. seventy percent of travelers from west africa enter through these states making them logical starting points for the program [ ] . after much legal debate and unwanted publicity, ms. hickcox mentioned in the introduction, eventually went into active monitoring program which restored most of her personal freedoms while at the same time protecting public interests. currently available technology is considered insufficient to prevent entry of ill individual into ebola naive countries. the general public continues to demand protection of civil liberties that include the freedom to travel and protection of privacy. despite recommendations by the cdc, it is difficult to identify an ill traveler either before a person embarks for the us or at the point-of-entry. post entry monitoring of reliably low risk travels is a socially acceptable alternative to quarantine and considered reliable although not widely tested. screening technologies such as infrared screens may not be considered useful on a daily use basis but may prove of utility under certain circumstances such as an active ebola outbreak. as research continues, technology advances, and better models to study patterns of disease spread are developed, new methods of pointof-entry biosecurity are sure to emerge. bioterrorism is the intentional spread of disease with the goal of destabilizing an opposing group. it is thought to have roots extending back to at least bce when the hittites used infected sheep to spread infection and destabilize their opponents [ ] . since that time, technology has improved and along with it the threat of bioterrorism has augmented. the center for disease control (cdc) divides bioterrorism agents into three separate categories a, b, and c. category a agents are those which are considered to be of highest risk. characteristics group a pathogens are, easy transmission, high mortality rate, protentional for social disruption, and require special action. category b agents are of concern, but considered to have a lower potential for disease than those in group a. this category is comprised of pathogens that are moderately easy to spread, have moderate morbidity, low mortality and require specific diagnostic and surveillance tools. group c are agents of some concern. this group is made of pathogens that are easily available, easy to produce and disseminate, and potentially have significant medical and public health implications. emerging infections also fall within group c pathogens. ebola is considered to be a high threat level a biothreat [ ] . bioweapons are at least as large a threat to homeland security as are traditional weapons. biological weapons are attractive to potential terrorists because they are relatively inexpensive to manufacture, easy to encounter, and easy to distribute [ ] . in the biological weapons convention went into effect. it has been signed by countries and prohibits the development of biological agents for the purpose of warfare. unfortunatly, terrorists fail to abide by this convention, and it is rumored that even some of the countries that signed the convention document continue to engage in clandestine research into biological agents for warfare. characteristics of a pathogen with bioterrorism potential are those with consistent disease induction and progression, high infectivity, are easily transmissible between people, are difficult to diagnose, and have a high mortality rate [ ] . it is also important that the pathogen be stable during production, storage, and distribution [ ] . lack of immunity in the targeted population and diseases that are difficult to diagnoses are also attractive to would-be terrorists. ebola possesses many of these characterizes. ebola possesses many features of an ideal bioterrorism weapon. in the early stages, ebola presents as an acute viral illness. by the time clinical features unique to ebola infection have developed, it is likely that the illness will already have be transmitted to others. particularly vulnerable are those caring for infected patients including family members and health care workers. despite being limited to transmission through body fluids, ebola is highly contagious. ebola has a high mortally rate and is attractive to terrorists because there is already widespread fear associated with ebola infection. reston virus, a non-human pathogen in the ebola family, can be transmitted. there is concern that with genetic manipulation evd could be transformed into an airborne illness and distributed as a bioterrorism weapon [ ] . ebola is one of the many pathogens that could potentially be converted into a biological weapon. preparedness plans at the local, state, and national level all include sections applicable to ebola. all hospitals in the nation have received training on ebola identification and response. continued vigilance and repetitive training sessions are required to ensure that should ebola be used as a biological weapon, it will be rapidly identified and contained. ebola virus is an agent that could be used as a bioterrorism agent. it is deadly, can result in long term infection in survivors, and non-specific clinical presentation make it an attractive choice for would be terrorists. also, for many people, the word ebola creates fear out of proportion to the actual risk of disease. this visceral reaction and exaggerated fear make ebola a tempting agent. on the other hand, the lack of airborne spread and existence of effective vaccine (even if not licensed) are deterrents to its use. it is impossible to know with certainty when the first ebola infection occurred. most likely it was in a remote african jungle and those infected died without a diagnosis other than that provided by the local traditional healer. what can be said with certainty is that the outbreaks are occurring with more frequency. no one knows with certainty why this is. hypothesis tend to center around issues of environmental degradation in association with increased population mobility. increasing population, global warming, and continued human encroachment into forested areas have been put forth as potential contributing factors. increasing population is theorized to be contributing to the increasing frequency of ebola outbreaks. increasing populations, particularly in developing countries, tend to lead to congesting living conditions and rapid disease spread, but this would not explain how the index case in an outbreak becomes infected. experts opinion often lists expanding population as contributing to the ebola outbreak, and intuitively it is credible, but there is little in the way of direct evidence to support this theory. literally hundreds of studies have been conducted on ebola since the outbreak, but none directly addresses the relationship between population growth in africa and increasing frequency of ebola outbreaks. it is likely that the impact of increasing human populations in endemic areas will not be fully understood until the reservoir of ebola has been determined. what we can say with certainty is that once started, ebola spreads more quickly than it did in the past and is killing more people. population level research on ebola has yielded interesting results. for a start, risk of ebola infection has been associated with a higher level of education [ , ] . lower risk for acquisition of ebola at the population level has been associated with urban residence, households with no or low-quality sanitary system, and married men in blue-collar professions in the outbreak in west africa [ ] . other studies have found different results when examining the interplay between population dynamics and the emergence of ebola. for example, in contrast to the study by levy & odoi, ebola transmission has been positively correlated with population density, and proximity to ebola treatment centers in other investigations [ ] . another study found that . % of people who tested positive for ebola cases lived within a -km of roads connecting rural towns and densely populated cities [ ] . basic public health principles hold that increasing population density allows infectious disease to spread more quickly, but it is unclear what the impact is on the emergence of ebola. it is safe that there is a relationship between population density, population distribution, and ebola but the exact nature of that relationship remains elusive. climate change has been cited by mass media sources as the source of emerging disease such as ebola. elevated atmospheric temperature have been associated with the development of evd, but then so have low temperatures [ ] . there does appear to be a relationship between ebola and temperature, but the character of that relationship is not clear. ebola virus is sensitive to high temperatures so intuitively, higher temperatures would not create a more active form of the virus. what may change is the human response to higher temperatures. when it is hot, people sweat more, drink more, and may wear different clothing. it may be that the human response to hot weather is responsible for the noted difference rather than changes in viral activity. it is also possible that temperature changes correlate with other phenomena such as rain storms and that rain, or the response of vegetation to rain somehow impacts the emergence of ebola. climate change, whether due to human activities or natural climatic cycles will change patterns of disease across the globe. how changing weather patterns may affect the distribution and frequency of ebola cases remains to be seen. possibly once the reservoir of ebola virus has been discovered scientists can predict with greater certainty how climate change will impact the emergence of ebola. it is also postulated that ebola is occurring with greater frequency due to increasing human activities within previously untouched natural areas. at least one study has linked deforestation to evd outbreaks [ ] . again, there are limited studies confirming this idea, but logic does suggest that it would be true. expert opinion, and the mass media purport that the increasing frequent outbreaks of ebola are due to environmental encroachment [ ] . as roads are build, forests are cut, and mineral resources exploited humans are in more intimate contact with the forest and its inhabitants including the reservoir for ebola. the reservoir is unknown, but it is probably found in african jungles. a study looking at vegetation cover, population density and incidence of ebola found that vegetation was protective until the population reached people per square km. at this population density vegetation became associated with and increase incidence of evd [ ] . there is a relationship between environmental encroachment and the emergence of ebola, but until the reservoir is found it will be difficult to determine the exact nature of this relationship. the frequency of ebola outbreaks has been increasing. international collaboration is essential to better understand how and why this is occurring. traditional tribal regions do not always follow country lines and both official and unofficial border crossing are common. contact tracing is essential for containment of ebola outbreaks requires countries to coordinate as people cross borders. epidemiological evaluation and experience in treating the disease also require a global rather than country approach. the study of ebola requires systematic evaluation and intercountry coordination to most effectively predict outbreaks and limit their spread once they do occur. the global community would also benefit from international standards for diagnosis, prevention, and treatment. luckily, framework already exists for this collaboration, at least in times of epidemics with pandemic potential. the international health regulations (ihr) agreement is legally binding accord signed by countries. it stipulated that these countries must act to contain the threat if a public health emergency of international concern (pheic) is declared by the who director general. a pheic was declared in august in response to the ebola outbreak in west africa [ ] . the ihr helps to ensure that an appropriate global health response will be made once a public health disaster is well underway. intervention at this level will help curb progression of the disaster. along this same line of thinking, mitigation and preparedness efforts are needed prior to development of a public health disaster. if a pheic is declared, then local measures have failed. improved regional collaboration is needed to help minimize the impact of ebola in the region. many countries at risk for outbreaks of evd would benefit from bolstering of their public health and medical programs. outside assistance is a starting point, but capacity building is required for long term solutions. in countries with weak public health infrastructure international efforts need to focus on programs to develop a sustainable public health system. the challenges are considerable particularly in areas of chronic conflict, but progress has already been made and with continued support will continue into the future. a basic public health infrastructure will help contain ebola as well as whatever threat comes next. when an ebola outbreak hits the general public needs to be educated on how to respond. if ebola preparedness is part of the local education, then lives can be saved. the public can help with surveillance efforts. this would require the population to trust the public health community, believe that their input is useful, and that they be trained to recognize potential ebola in the community. public health education can also assist with limiting spread if an outbreak does occur. this education can be provided through schools, community outreach campaigns, or religious institutions. the education does not need to be complex, just consistent, concise, true, and culturally appropriate. outbreaks of evd have been occurring with increasing frequency. thousands have died and thousands more have been lives have suffered because of the disease. the disease is highly fatal, but even more insipid, it exploits traditional ceremonies and death-rights as a means of spread. poverty, both at personal and national level has resulted in an infrastructure ill-equipped to deal with events such as ebola. overcrowding promotes transmission and lack of financial incentives have delayed vaccine development. despite the barriers, evd is slowing being more well understood, thousands of research articles have been published, and guidelines for every aspect of the disease have been published by the who, cdc, or other government level organizations. progress is being made. esposure patterns driving ebola transmission in west africa: a retrospective observational study assessment of the risk of ebola virus 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congo: discovery and control measures multiple ebola virus haemorrhagic fever outbreaks in gabon ebola virus in breast milk in an ebola virus-positive mother with twin babies managing ebola from rural to urban slum settings: expierences from uganda recent loss of closed forests is associated with ebola virus disease outbreaks afr: riv trimest stud documentazione dell'istituto ital l'afr l ebola virus rna detection on fomites in close proximity to confirmed ebola patients; n'zerekore experimental inoculation of egyptian fruit bats (rousettus aegyptiacus) with ebola virus public health screening at us ports of entry: guidelines for inspectors prevention cf ( ) us quarantine stations field investigations of an outbreak of ebola hemorrhagic fever, kikwit, democratic republic of the congo, : arthropod studies feb) clinical, virologic, and immunologic follow-up of convalescent ebola hemorrhagic fever patients and their household contacts, kikwit, democratic republic of the congo. commission 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interim guidance ebola virus disease: faq: compassionate use of ebola vaccine in the context of the ebola outbreak in north kivu, democratic republic of the congo who: international commission ( ) ebola haemorrhagic fever in zaire who: international study team ( ) ebola haemorrhagic fever in sudan who interim guidance for ebola: exit screening at airports, ports and land crossings november ) who interim guidance for ebola: exit screening at airports, ports and land crossings ebola fact sheet the cdc's new quarantine rule could violate civil liberties. the atlantic a novel immunohistochemical assay for the detection of ebola virus in skin: implications for diagnosis, spread, and surveillance of ebola hemorrhagic fever key: cord- -ntq huc authors: wright, natalie; fagan, lucy; lapitan, jostacio m.; kayano, ryoma; abrahams, jonathan; huda, qudsia; murray, virginia title: health emergency and disaster risk management: five years into implementation of the sendai framework date: - - journal: int j disaster risk sci doi: . /s - - -x sha: doc_id: cord_uid: ntq huc the sendai framework for disaster risk reduction – recognizes health at the heart of disaster risk management (drm) at the global policy level. five years on, it has catalyzed the rapid development of the field of health emergency and disaster risk management (health edrm) by providing a mandate for building partnerships as well as enhancing scientific research. key milestones achieved include publication of the world health organization’s health edrm framework, development of the who thematic platform for health edrm and the who health edrm research network, and further application of health information principles to drm. furthermore, health actors at all levels have continued to engage in the sendai framework processes and have had a key role in its implementation and proposed monitoring. there have been significant gains made through the partnership of health and drm, but the relationship has not been without its challenges. many national, regional, and global initiatives continue to operate with a lack of consistency and of linkages to respond to the sendai framework’s call for embedding health resilience in drm, and conversely, embedding drm in health resilience. overcoming this hurdle is important, and doing so will be a key marker of success of the next years of partnership under the sendai framework. . with the synchronous adoption of the sendai framework as a landmark un agreement that links closely with the sustainable development goals (sdgs) (unga ) , paris climate agreement (unfccc ) , and the outcomes of the world humanitarian summit (unga a) and habitat iii (unga b) the aim has been to develop dynamic, local, preventive, and adaptive governance systems at the global, national, and local levels. these landmark un agreements aim to develop and lead a global process that can create a rare but important opportunity to build coherence across different but overlapping policy areas . taken together, these frameworks aim for a more complete agenda for action that spans health, development, humanitarian action, disaster risk management (drm), and climate change adaptation. communicating and understanding the value of the sendai framework across all sectors, including for and to health professionals, is critical for progress on the health priorities. the sendai framework recognizes that by reducing and managing conditions of hazard, exposure, and vulnerability-while building the capacity of communities and countries for prevention, preparedness, response, and recovery-losses and impacts on health from disasters can be more effectively alleviated through a multisectoral approach rather than focusing exclusively on emergency response. while there were several references to health in the hyogo framework for action (undrr , the adoption of the sendai framework marks the first time that the fields of health and drm have been substantially interwoven at the global multisectoral policy level. this article builds on previous efforts to discuss this merger (aitsi-selmi and murray ; aitsi-selmi et al. b; maini et al. ) and explores its effects years on, not just in terms of global policy and partnership, but also in terms of the effects for scientific research and data in the field of drm. the health sector has a long-standing history of excellence in developing evidence-based policy and practice, with globally recognized organizations dedicated to this endeavor. cochrane is a leading example of such an organization. it is a non-profit institution, set up in , which works with over contributors globally to produce high quality, accessible health information, free from commercial interests. it advocates the principles of evidence-based medicine as critical to health policy and practice, and in assessing the effectiveness of interventions for disease prevention, treatment, and rehabilitation (turner et al. ) . cochrane reviews are recognized as the highest standard of systematic reviews in health care and are published online in the free-access cochrane database of systematic reviews in the cochrane library (cochrane ). evidence aid is another example of a leader in the field of evidence-based practice in the health sector. the organization, which has charitable status in the united kingdom, uses evidence from systematic reviews to provide upto-date advice on interventions in the context of planning for or responding to disasters, humanitarian crises, and other major healthcare emergencies (khalid et al. ) . it seeks to identify which interventions are most and least effective-including those that may unintentionally cause harm. the un system and its member states have achieved globally agreed guidelines for drm since (undrr ). historically, the health impacts of disasters were poorly reflected in this international dialogue. the yokohama strategy and plan of action for a safer world (international decade for natural disaster reduction ) did not mention health or health care facilities at all. its successor, the hyogo framework, mentions health as a sector and health care facilities three times, but not as an explicit goal or outcome of drm. the world health organization (who) and its partners have a set of programs for managing and preventing health emergencies that predate the adoption of the sendai framework. there are several other key programs. in particular, the international health regulations (ihr) ( ) constitute an important legal tool for un member states, which is designed to facilitate the prevention of and the response to acute public health risks that have the potential to cross borders and pose global threats to health (who a; for wider perspectives on international law, see aronsson-storrier ). also, the inter-agency standing committee (iasc) emergency response preparedness (erp) draft for field testing sets standards for risk analysis and monitoring, and minimum and advanced preparedness including contingency planning, with the aim of optimizing the speed and volume of critical assistance provided immediately following the onset of a humanitarian emergency (iasc ) . building on all this work, the sendai framework puts health risks and health resilience at the heart of global drm efforts. it advocates for involving health sectors throughout planning for emergency proactive and reactive measures globally, as well as highlighting the critical role of science and technology. there are references to health, including links to epidemics and pandemics, alongside several references to the ihr (who a) and to rehabilitation as part of disaster recovery. some examples are: to enhance the resilience of national health systems, including by integrating disaster risk management into primary, secondary and tertiary health care, especially at the local level; developing the capacity of health workers in understanding disaster risk […] and supporting and training community health groups in disaster risk reduction approaches in health programmes, in collaboration with other sectors, as well as in the implementation of the international health regulations ( ) being part of the un system, the world health organization contributed to the lead-into the sendai framework and is now an active supporter and implementer of it. the who reports in its th general programme of work (gpw ) for - that major global health gains have been made in recent years, yet complex, interconnected threats, such as poverty and inequality to conflict, and poor governance remain. the gpw , which sets out who's strategic direction for the next years and was approved by the seventy-first world health assembly in resolution wha . on may , is informed by the un's agenda for sustainable development, and in particular sdg : to ensure healthy lives and promote wellbeing for all at all ages (who ). the focus of gpw is to deliver meaningful, largescale, country-level impact to promote health, improve health security, and serve vulnerable communities. a key pillar of this vision is to reduce the risks and impacts of all types of health emergencies. the gpw recognizes that ''the world faces threats from high-impact health emergencies (epidemics, pandemics, conflicts, natural and technological disasters) and the emergence of antimicrobial resistance'' (who , p. ) . it has at its heart a set of interconnected strategic priorities and goals through the ''triple billion'' target, which includes: billion more people benefitting from universal health coverage; billion more people better protected from health emergencies; and billion more people enjoying better health and well-being (who ). in the context of health emergencies, the who will ''work with member states and partners to increase allhazards health emergency detection and risk management capacities across all phases of risk prevention and detection, emergency preparedness, response and recovery through the implementation of the ihr ( ) and the sendai framework for disaster risk reduction'' (who , p. ) . the gpw goes on to state that ''who's approach to health emergencies is described in the results framework of the health emergencies programme. it seeks to ensure that: • populations affected by health emergencies have access to essential life-saving health services and public health interventions; • all countries are equipped to mitigate risk from highthreat infectious hazards; • all countries assess and address critical gaps in preparedness for health emergencies, including in core capacities under the ihr and in capacities for allhazard health emergency risk management; • national health emergency programmes are supported by a well-resourced and efficient who health emergencies programme.'' (who , p. ) recognizing the complexity of delivering on the ambitions for health in the sendai framework, the who, together with national ministries of health, un agencies, and partners, has sought to build greater coherence and interlinkages among these actors and initiatives through the who thematic platform for health edrm, which has the intent to promote health resilience in a consistent manner, both within and beyond the health sector. the thematic platform recognizes that engagement and collaboration with the wider health system and other sectors (especially at local levels) is critical in the prevention of health risks, as many of the necessary actions to reduce hazards and vulnerabilities rests with the activities of other sectors. the thematic platform was also actively engaged during the negotiations of the sendai framework, providing advice on health to member states, and playing a crucial advocacy role. since , the thematic platform has provided advice and recommendations on health issues to member states on the implementation of the sendai framework and advanced efforts to mainstream drm within the work of the who and other health partners, as well as promoted health within drm. some of the key outputs of the thematic platform have been facilitating inputs from more than experts to develop and revise a series of fact sheets on various aspects of health emergency and disaster risk management, organize key workshops and forums at the global platform for disaster risk reduction, and provide health-related inputs to undrr reports and thematic conferences (for example, science and technology). the thematic platform is guided by, and supports the implementation of, the sendai framework, the sdgs, and the paris agreement, along with the ihr, who resolutions, and other regional and global frameworks. some initiatives, such as the collaboration on disaster education for medical studies, have grown extensively and include links with the international federation of medical students associations and many academic partners including the centre for research disaster and emergency medicine at the university of eastern piedmont in italy. the who, along with its partners, has a number of other ongoing programs that it implements for health emergencies that support the implementation of the ihr, sendai framework, pandemic influenza preparedness framework, and other global policies. these include: • the who strategic framework for emergency preparedness, which lays out the principles and constituents of effective country health emergency preparedness (who ); • the who's an r&d blueprint for action to prevent epidemics, a global strategy and preparedness plan that supports the rapid implementation of research and development activities during epidemics (who b); and • the ihr ( ) monitoring and evaluation framework that includes annual reporting by states parties, simulation exercises, after action reviews, and voluntary joint external evaluation, which is a collaborative process to assess a country's capacity to adhere to the ihr requirements (who c). other global initiatives include the global health security agenda (ghsa), a non-binding coalition of countries and organizations working to strengthen capacity to respond to infectious disease threats and promote health security as a national and global priority (bali and taaffe ) . in their own rights, these initiatives have taken (and continue to take) important steps towards improving the prevention, detection and response to health emergencies globally. furthermore, they point to the fact that the sector is implementing many aspects of the sendai framework already, given its references to biological hazards and the ihr ( ). there remains a lack of joined up working to fully respond to the sendai framework's call for promoting health resilience in a consistent manner both within the health sector itself and more broadly across sectors. the who health emergency and disaster risk management framework aims to facilitate this consistency of approach. drawing on the learning from years of implementing the health aspects of the sendai framework by ministries of health and partners, as well as successive global and regional frameworks on emergency preparedness, drm, and the ihr of , the who launched a new framework for health edrm at the global platform for disaster risk reduction in (who ). this framework addresses the many issues raised by the sendai framework and is designed to provide an overarching frame to bring together the many vital initiatives to deliver disaster risk management and increase preparedness for public health emergencies. the framework also aims to embed a health edrm within existing health systems, thus enabling a greater emphasis on risk prevention and building health resilience at community and national levels, community resilience, along with preparedness, response, and recovery. the health edrm framework has a clear vision-the ''highest possible standard of health and well-being for all people who are at risk of emergencies, and stronger community and country resilience, health security, universal health coverage and sustainable development'' (who , p. x) it aims to strengthen capacity, within and beyond the health sector, to tackle the health impacts of all types of emergencies and disasters, as well as to work to reduce the health risks of future events. the framework is derived from the disciplines of risk management, emergency management, epidemic preparedness and response, and health systems strengthening. it places an emphasis on multisectoral action and, importantly, recognizes the importance of building resilience as part of the wider health system strengthening approach and the journey to achieve universal health coverage in all country contexts (see box ). it is fully consistent with existing drm and health emergency policies and seeks to provide a framework for aligning these in future. at the time of writing, the health edrm framework was recently published, and is in the earliest stages of implementation. plans are in place for wide engagement with ministries of health for training and development on strategies and programs through who regional and country offices and partners. specific actions to support operationalization of the health edrm framework include accelerating implementation of the national action planning for health security (naphs) process, strengthening an all-hazards approach to strategic emergency risk assessments and emergency response planning, mainstreaming drm in all health policies and programs, and supporting improved sendai framework reporting by ministries of health. going forward, it will be vital to continue to proactively implement the framework, particularly at the country level, and to evaluate its impact globally. there are a number of regional approaches established by who regional offices, which have referenced the sendai framework in efforts to bring together health and drm. for example, in , the regional committee for south east asia approved the resolution on response to emergencies and disaster, which reflects emergency and disaster risk management as a flagship priority area (who ) . it makes explicit reference to the sendai framework as well as the ihr and sdgs, and reaffirms the need for drm policies across sectors and at all levels of government, to ensure the effective response to disasters and other emergencies. this response was taken one step further by the who regional office for the americas/pan-american health organization (paho). responding to the ambitious agenda set out in the sendai framework as well as reforms to the outbreak response capacity of the who, paho launched the regional plan of action for disaster risk reduction - (paho . approved by the member states in september , the plan provides an operational framework to guide the implementation of drm policies and programs in the health sector. it contains four strategic lines of action that are consistent with the sendai framework and are aimed at reducing the health impacts of disasters and emergencies: ( ) recognizing disaster risks; ( ) strengthening governance of disaster risk management; ( ) promoting safe and smart hospitals; and ( ) strengthening the sector's capacity for emergency and disaster preparedness, response, and recovery. a progress report, published in , showed that at least member states of paho had undertaken, or were in the process of undertaking, a national evaluation of disaster risk in the health sector. furthermore, there had been an increase in the number of countries with full-time staff and an allocated budget for health drm (paho ). this represents an important step forward in health emergency and disaster risk management, translating global ambitions on health and drm into a concrete and contextualized set of actions for implementation. however, more action on the multisectoral dimensions of health edrm is needed. the progress report also found only eight countries had a multisectoral plan for recovery after emergencies and disasters-just over % of those that responded. moving ahead, it is critical to align health and drm strategies at regional, national, and local levels, ensuring that health is represented in disaster risk reduction plans (target (e)) and national adaptation plans. embedding health into drm at the policy level, with its principles of evidence-based policy making, as shown in sects. and , has had the resultant effect of bringing in new scientific methods and rigor. health based scientific research and outcomes are needed to identify needs and knowledge gaps. working in partnership with the undrr science and technical advisory group (undrr stag) and linking health to drm to implement the sendai framework will have significant impact particularly when the call for action in paragraph (g) of the sendai framework (undrr ) to ''enhance the scientific and technical work on disaster risk reduction'' is followed. in order to achieve this, health, science, and technology communities and networks should mobilize and strengthen existing capacities and initiatives to working to co-design, co-produce, and co-deliver new knowledge that is readily available and accessible. •policies, strategies and legislation defines the structures, roles and responsibilities of governments and other actors for health edrm; includes strategies for strengthening health edrm capacities. •planning and coordination emphasizes effective coordination mechanisms for planning and operations for health edrm. •human resources includes planning for staffing, education and training across the spectrum of health edrm capacities at all levels, and the occupational health and safety of personnel. •financial resources supports implementation of health edrm activities, capacity development and contingency funding for emergency response and recovery. •information and knowledge management includes risk assessment, surveillance, early warning, information management, technical guidance and research. •risk communications recognizes that communicating effectively is critical for health and other sectors, government authorities, the media, and the general public. •health infrastructure and logistics focuses on safe, sustainable, secure and prepared health facilities, critical infrastructure (e.g. water, power), and logistics and supply systems to support health edrm. •health and related services recognizes the wide range of health-care services and related measures for health edrm. •community capacities for health edrm focuses on strengthening local health workforce capacities and inclusive community-centred planning and action. •monitoring and evaluation includes processes to monitor progress towards meeting health edrm objectives, including monitoring risks and capacities and evaluating the implementation of strategies, related programmes and activities. source who ( , p. x-xi) . coherence between the sendai framework, the sdgs, the paris agreement, the new urban agenda, and the world humanitarian summit, and the role of science in their implementation support the implementation of the post- framework from the local to the global scale. the undrr stag report recommends the delivery of outputs as detailed in box . the use of scientifically derived evidence by government is not without its difficulties, however, particularly in the context of today's geopolitical climate and ongoing debate about the role of scientific experts in policy making (ross et al. ; pearce et al. ) . engaging policymakers in science does not just mean making research results available. it also means helping them understand the implications and working with them to decide how to respond, and what further research or other activity is needed. many of these challenges were discussed at the undrr science and technology conference on the implementation of the sendai framework for disaster risk reduction - dickinson et al. ) as well as at the meeting in tokyo in (science council of japan ). other international science meetings have been held across the world with specialist health groups engaging to consider how best to support the need for evidence to inform policy and practice. possible strategies for achieving this include building on existing programs that are known to be effective, strengthening relationships across sectors nationally and globally, and considering reworking policy narratives (bardosh et al. ). as part of the solutions identified, representatives of the health community and who worked together to set up a research network for health edrm. the who health edrm research network links to the who thematic platform for health edrm and was initially proposed in and formally launched in . the research network aims to serve as an international multistakeholder and interdisciplinary platform to exchange information, share views, and advise who in the area of health edrm research and evidence-related activities in general and on the following issues in particular: • the development of information sharing platforms on research and activities relating to health edrm being undertaken across the world; • the development of partnerships between stakeholders to enhance the scientific and technical work on health edrm, influence the international health edrm research agenda, and advocate for greater health input within the wider disaster risk reduction community; • the provision of technical advice and review of guidance for health edrm research initiatives and the standardisation of related programmes; and • the provision of support to the who in other aspects of its health edrm work, where applicable. also promoted by the research network are partnerships among stakeholders to enhance the scientific and technical work on health edrm, influence the international research agenda, and advocate for greater health input within the wider drm community. the research network comprises the core group, participants, and a wider information-sharing network. who headquarters and regional offices are involved in the operation of both the thematic platform and the research network, and work together to discuss research needs, facilitate international research collaboration, and improve knowledge management. the who kobe centre acts as the secretariat for this platform. •scientific advice to decision-makers through close collaboration and dialogue to identify knowledge needs including at national and local levels, and review policy options based on scientific evidence; and •monitoring and review to ensure that new and up-to-date scientific information is used in data collection and monitoring progress towards disaster risk reduction and resilience building. in addition, two cross-cutting capabilities need to be strengthened: •communication and engagement among policy-makers, stakeholders in all sectors and in the science and technology domains themselves to ensure useful knowledge is identified and needs are met, and scientists are better equipped to provide evidence and advice; and •capacity development to ensure that all countries can produce, have access to and effectively use scientific information. the unique value of the research network lies in its ability to leverage capacity across the six who regions, enabling ( ) strengthening of the evidence base on health edrm on a global scale; and ( ) the rapid dissemination of emerging evidence to member states. the ability for rapid and widespread dissemination facilitates the implementation of health edrm policy and practice founded on the most robust and up-to-date evidence available. this, in turn, should maximize the opportunities at national, regional, and community levels to implement the most effective evidence-based programs known that reduce the risks and impacts of disasters to the world's most vulnerable populations. in doing so, this should enable countries to strengthen their capacities in health edrm and ultimately contribute to one billion more people being safe during emergencies. the research network and other key partners have identified, through a meeting convened by the who kobe centre in , five research priority areas before, during, and after emergencies and disasters: • health data management this research priority focuses on developing tools and methodologies to support timely and accurate data collection, analysis, and dissemination in recognition of the critical importance of reliable data in the provision of effective health support in disaster relief and recovery. emergencies and disasters can place significant and persistent mental health pressures on those affected, including the responders. understanding the most effective approaches to embedding mental health and psychosocial support into disaster response is an essential part of health edrm. • addressing the health risks and needs of subpopulations, including health literacy understanding the health vulnerabilities, capacities, and inequities of communities and specific subpopulations is critical to disaster risk management. a detailed description of the expert meeting and its findings was published in a series of papers (aung et al. ; généreux et al. ; kayano et al. ; kubo et al. ) . in , the who kobe centre launched the first call for proposals on health edrm addressing the first four priority areas. the development of the who guidance on research methods for health edrm, which addresses the fifth research priority, is currently underway. the who guidance on research methods for health edrm is presented as a resource textbook comprising chapters authored by contributors from countries around the world, with a wide variety of health edrm disciplines. the book is structured around six sections: introduction; identifying and understanding the problem; assessing the problems and developing a scoping study; study design; special topics to demonstrate research processes and benefits; and how to become a researcher. it includes an extensive series of case studies, from individual countries and from more than two countries or of global relevance. the book is edited by six leading experts in health edrm and has over peer reviewers from countries. it is expected to be published in on open access via the who kobe centre website. the publication of this guidance initiative is particularly useful for all health professionals in health edrm, given the overall lack of research in the field of health edrm and the consequently limited evidence base. it will facilitate, enable, and enhance health edrm researchers to increase the depth and breadth of evidence available, which will inform and foster evidence-based policy and practice in the field. it will also enable the harmonization of health edrm research with universal terms; the use of mechanisms to facilitate and speed up the ethical review process; increased community participation and stakeholder involvement in generating research ideas and in assessing impact evaluation; and the development of reference materials such as consensus statements. the adoption of the sendai framework by the un member states includes agreement on seven global targets to assess progress in drm: undrr has developed technical guidance for monitoring and reporting on national progress in achieving these targets and has prepared a web-based tool to support this reporting (undrr ) as well as a training package for member states. most member states have a sendai framework monitoring national focal point with responsibility for national reporting on the sendai framework targets. many of these targets (and many of the associated indicators) have clear links to the health impacts of disasters. for example, there are health specific indicators on mortality (a- ), people injured and ill (b- ), damage and destruction of health facilities (d- ), and disruption to basic health services (d- ). access to these health data is integral to timely, accurate, and complete reporting to the sendai framework monitor. because ministries of health hold relevant data related to health outcomes, risks, and capacities, it is vital that ministries of health are engaged with the sendai framework monitoring national focal point and work collaboratively with relevant partners to ensure comprehensive and fig. links between sendai framework targets and sustainable development goals accurate reporting. to date, this engagement across member states is mixed, with % ( / ) reporting against mortality targets in and % ( / ) in (undrr n.d.) . going forward, it is vital to continue working to maximize engagement across all member states. the who technical guidance notes on sendai framework reporting for ministries of health is one tool that aims to facilitate this engagement, and provides guidance for the health sector on its role in data collection and reporting, as well as detailed descriptions of health specific indicators (who due for publication in early ). health sector reporting to the sendai framework monitor will enable ministries of health to measure annual trends of the effects of emergencies and disasters on health, review progress in strengthening capacities, and prioritize areas for further action. there are also clear links to reporting on the sdgs. figure highlights the web of links between targets of the sendai framework and the sdgs, including the sdg target d: strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction, and management of national and global health risks. there are several benefits to building coherence between reporting for the sendai framework monitor and the sdgs. these include increasing awareness at national and subnational levels of government on how the two frameworks align; facilitating key partnerships, which help avoid duplication of data collection and reporting; promoting accountability; and enabling the development of overarching strategies for collective action on findings in order to maximize gains for both the health and disaster risk management sectors. there are several developments that could support the engagement of ministries of health in supplying data for inclusion in the member state reporting process. member states should consider organizing health sector trainingregionally, nationally, and subnationally-in methods to improve monitoring and reporting on sendai targets. they should also consider further review of undrr technical guidance and training for the development of disaster data bases. in the medium and longer terms, ministries of health could consider strengthening national and subnational capacities for civil registration and vital statistics, and developing national case registries for mortality and morbidity related to hazardous events, including emergencies and disasters (green et al. ). the growing recognition of health as a core dimension in drm has catalyzed the development of health edrm, a field that encompasses emergency and disaster medicine, drm, humanitarian action, global health security, adaptation to climate change, and resilience of health systems, communities, and countries. this has led to developing the who health edrm framework, which aligns with the who's gpw : a critical tool for who member states to set and approve the priorities of the organization, define the targets to be delivered, and to monitor their achievements. the gpw is structured around three strategic priorities, one of which specifically addresses health emergencies and aims to build and sustain the resilient health systems required to reduce the risks of epidemics and other health emergencies. the who health edrm research network was established in direct response to contributing to the sendai framework in general and the sendai framework monitor in particular. the network aims to strengthen research in health edrm and to promote the sharing of knowledge and evidence globally. this marks a crucial step towards enhancing evidence-based policy making and practice, and is a key enabler for delivering truly joined-up efforts. despite the perceived success of the framework and the research network, many national, regional, and global initiatives continue to operate with a lack of consistency and harmony in their response to the sendai framework's call for the embedding of health resilience in drm, and conversely, the embedding of drm in health resilience (wisner ) . the health sector is implementing many aspects of the sendai framework already, but there is a weakness in the way it recognizes, records, and reports this implementation. the policies, programs, and actions taken by governments, who, and partners that are aimed at reducing the risks and impacts of emergencies and disasters show the range of health sector actions that could be considered as evidence of implementing the sendai framework. going forward, effective and efficient coordination of work is critical, building on emergency preparedness and response, while simultaneously putting a greater emphasis on prevention and recovery. this requires close collaboration with the wider health system and engagement with other sectors-a key public health approach-given that many of the actions to prevent health risks (by reducing hazards and vulnerabilities) rest with the activities of other sectors. ministries of health and their partners are encouraged to engage further with the application of the health edrm framework, with the who thematic platform for health edrm and its associated research network, and in reporting to their national focal points for the sendai framework monitor. this will enable ministries of health to measure the effects of emergencies and disasters on health, review progress in strengthening capacities, and prioritize areas for further action. the engagement of the ministries of health will therefore be a key marker of success in the effort to nurture the partnership of health and drm under the sendai framework. the sendai framework: disaster risk reduction through a health lens united nations international strategy for disaster reduction, science and technical advisory group report : science is used for disaster risk reduction the sendai framework for disaster risk reduction: renewing the global commitment to people's resilience, health, and wellbeing reflections on a science and technology agenda for st century disaster risk reduction. based on the scientific content of the unisdr science and technology conference on the implementation of the sendai framework for disaster risk reduction sendai five years on: reflections on the role of international law in the creation and reduction of disaster risk research methods and ethics in health emergency and disaster risk management: the result of the kobe expert meeting the sustainable development goals and the global health 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disaster reduction annual report of the secretary general on the implementation of the international strategy for disaster reduction transforming our world: the agenda for sustainable development. outcome document of the united nations summit for the adoption of the post- agenda outcome of the world humanitarian summit: report of the secretary-general (a/ / ) unga (united nations general assembly) response to emergencies and outbreaks-sea/rc /r . geneva: world health organization who (world health organization). b. an r&d blueprint for action to prevent epidemics: plan of action ihr ( ) monitoring and evaluation framework . a strategic framework for emergency preparedness thirteenth general programme of work health emergency and disaster risk management framework five years beyond sendai-can we get beyond frameworks? acknowledgements we would like to acknowledge the contribution of tristana perez in the global public health team, public health england in the development of fig. in this article.open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creativecommons. org/licenses/by/ . /. key: cord- -uijafp p authors: vögele, jörg; koppitz, ulrich; umehara, hideharu title: epidemien und pandemien in historischer perspektive date: - - journal: epidemien und pandemien in historischer perspektive doi: . / - - - - _ sha: doc_id: cord_uid: uijafp p seuchenzüge treten definitionsgemäß in intervallen auf. da ihre Ätiologie und epidemiologie im vorfeld zunächst meist mit erheblichen unsicherheiten behaftet sind, werden historische denkweisen und analogien herangezogen, um seuchengefahren zu erkennen und gegenmaßnahmen zu treffen. die zugrunde liegenden traditionen lassen sich teilweise über jahrzehnte oder gar jahrhunderte zurück verfolgen. jahrhundert; hier ist die zahl der vorliegenden studien nahezu abundant, wobei regelmäßig auf neue wege in der seuchengeschichte hingewiesen wird . im folgenden sollen deshalb zunächst ( . ) globale langfristige entwicklung der epidemien auf der basis einer historischen epidemiologie skizziert werden . anschließend sollen ( . ) einige ausgewählte zugangsmöglichkeiten skizziert und im anschluss umgekehrt ausgehend von ausgewählten gastroenteritiden potentielle zugänge zu einer geschichte der seuchen abgeleitet werden . schließlich werden ( . ) die in diesem band veröffentlichten beiträge zur internationalen arbeitstagung "epidemics and pandemics in historical perspective", die im oktober anlässlich des . geburtstags von alfons labisch in düsseldorf organisiert wurde, im Überblick vorgestellt . der besondere dank der herausgeber gilt der deutschen forschungsgemeinschaft (dfg), der heinrich-heine-universität, der philosophischen und der medizinischen fakultät, welche die tagung finanziell unterstützt haben, sowie der anton betz stiftung für einen druckkostenzuschuss . schließlich danken wir auch den vielen mitgliedern des instituts für geschichte der medizin, die an tagung und tagungsband mitgewirkt haben . england and germany, - (liverpool: lup, ein weiterer forschungsschwerpunkt beschäftigt sich mit den kollektiven Ängsten angesichts von seuchen sowie den bedürfnissen nach erklärungen und kontrolle . seuchen wurden und werden als gleichsam (über-) natürliche strafen für fehlverhalten interpretiert . hier kann den funktionsweisen der attribuierung von schuld sowie den interpretationsrahmen von epidemien nachgespürt werden . sowohl in der hochkultur als auch im alltagsleben haben seuchenwahrnehmungen unzählige spuren hinterlassen . für die zeitgenossen ein zentrales element war bzw . ist der umgang mit der seuchenfurcht . der rolle der medien kann hier eine wichtige bedeutung zukommen . auch in der belletristik wurden seuchen häufig thematisiert, um einerseits das faszinosum nach zeitgenössischem kenntnisstand zu schildern, andererseits auch als stilmittel um die handlung in gang zu bringen . als movens werden seuchen nicht nur in kultur, religion, politik, presse und geisteswissenschaften instrumentalisiert, sondern bevorzugt auch in der gesundheitspolitik . der durch historisch gewachsene institutionen begünstigten Überbewertung von seuchen im gesamtmortalitätsspektrum durch die gesundheitsberichterstattung entspricht die begriffswahl bei weiteren kampagnen . diese phänomene können im sinne einer emotionalen epidemiologie oder im sinne alfons labischs als "skandalisierung" analysiert werden . die zweite sektion "decameron revisited: cultural impact" widmet sich methodisch und inhaltlich den kulturgeschichtlichen auswirkungen von seuchen, insbesondere der rezeptionsgeschichte der pest . einführend interpretiert kay peter jankrift (augsburg) darstellungen der pest in der grimmschen sagensammlung . im bereich der bildenden kunst hinterfragt stefanie knÖll (düsseldorf) anhand von graphiken mit totentanz-motiven das verhältnis von tradition und zeitgenössischer seuchenerfahrung im . jahrhundert . vom choleradiskurs ausgehend kommentiert reinhard spree (berlin) in der engeren medizingeschichte weichen die schilderungen von abenteuerlichen expeditionen und spannenden experimenten als moderne heldengeschichte(n) weitgehend zeitgemäßen wissenschaftshistorischen analysen wie netzwerk-oder laborstudien . nicht mehr eine lineare erfolgsgeschichte, sondern die historizität der wege der forschung steht dabei im vordergrund . oder im rahmen der kriegsforschungen z .b . zur malaria . häufig spiegeln konzepte, etwa der parasitologie und daraus abgeleiteter strategien, den kontext ihrer entstehung wider, treten als soziale konstruktion in den vordergrund und transportieren gesellschaftliche implikationen . nicht nur aus der vormoderne überlieferte epidemien und pandemien erscheinen -wie in den ersten beiträgen dieses bandes ausgeführt -in der retrospektiven diagnose problematisch, streng genommen muss auch der epidemiologische einfluss zeitgenössischer therapien retrospektiv stets zweifelhaft erscheinen . angesichts bleibender unsicherheiten rückversichert sich die seuchenbewältigung vor ort daher mit globaler expertise, z .b . durch internationale organisationen wie die league of nations health organisation (später who), das rote kreuz bzw . die rockefeller foundation . der vermittlung gesundheitspolitischer und medizinischer maßnahmen? während zur seuchengeschichte von der antike bis ins . jahrhundert zahlreiche forschungen vorliegen, sind viele dieser fragen noch immer ohne antworten geblieben . auch in methodischer hinsicht eröffnet die seuchengeschichte ein komplexes feld, das mit neuen sozial-und kulturgeschichtlichen ansätzen erschlossen werden kann . die geschichte der seuchen hat nach wie vor konjunktur . auf dem düsseldorfer workshop, dem eine tagung in oldenburg folgte, sollten daher forschungen zur geschichte der seuchen und infektionskrankheiten diskutiert werden, die forschungslücken schließen und, wie seinerzeit von martin dinges gefordert, "neue wege in der seuchengeschichte" beschreiten . ursachen für hohe mortalitätsziffern der indigenen amerikas sowie der von den usa ausgehenden sog verkehrsströme und migrationsbewegungen aber auch verhaltensweisen in den blick . schließlich treffen seuchen lokal und regional auf unterschiedliche bedingungen (the global and the local) the red 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cord- -lezggdjb authors: hannah, adam; baekkeskov, erik title: the promises and pitfalls of polysemic ideas: ‘one health’ and antimicrobial resistance policy in australia and the uk date: - - journal: policy sci doi: . /s - - - sha: doc_id: cord_uid: lezggdjb recent scholarship posits that ambiguous (‘polysemic’) ideas are effective for coalition building between diverse stakeholders: their capacity to be interpreted differently attracts different interests. hence, in search of political solutions to ‘wicked’ and similarly complex problems, deploying polysemic ideas would be critical to effective policy-making. this paper scopes the policy-making potential of polysemic ideas by examining the impact of an ambiguous concept known as ‘one health’ on responses to antimicrobial resistance (amr) in australia and the uk. it offers two primary arguments. firstly, polysemic ideas can help mobilise broad attention to complex problems: since one health became associated with amr, political and administrative attention has grown more intense and coordinated than previously. secondly, however, a polysemic idea alone may be insufficient to generate effective action: the contrast between australian and uk amr policies illustrates that polysemic ideas do not suspend interests, institutions, or ideas that can be readily deployed. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorised users. how much can conceptual ambiguity help policy-makers when they address difficult public problems? this article focuses on potentials for ideas with a 'polysemic' or 'chameleonic' character to aid in forming and sustaining policy-making coalitions (smith ) . that ideas are critical for understanding public policy outcomes is now well established. the literature in recent decades has outlined various types of and roles for ideas at all stages of the policy process. observing that ideas may mean different things to different people or groups if their meanings are ambiguous ('polysemic'), béland and cox ( ) argue that polysemic ideas can pull together actors with different interests or mobilise disengaged interests. this account of ideas suggests that ambiguous concepts or frames can be crucial in contemporary policy design and development. public policy-making is described as increasingly complex because public problems are 'wicked' and crises frequent (head and alford ) . contemporary policy-making combines difficult problems with fragmentation of interests, scientific uncertainty, and decentralised authority. polysemic ideas may aid policy-making by attracting to coalitions or networks actors who tend to disagree over interests and specific ideas. such 'big tent' coalitions appear to promise higher likelihood for policy solutions. the crucial potential for overcoming intractable policy inaction in the face of contemporary policy challenges motivates further study to understand how far polysemic ideas can take policy-making. what follows explores this potential empirically through analysis of a polysemic idea's impact on policy-making in australia and the uk against a difficult problem. the 'one health' concept is a polysemic idea par excellence. it has no established meaning beyond the assumption that human, animal, and environmental health are interdependent. yet from about , it has emerged as the global approach to countering the growing threat of antimicrobial resistance (amr) (world health organization ) . our australian and uk case analyses first examine whether introducing one health resulted in diverse stakeholder coalitions for amr responses. they then investigate whether amr responses depended on one health approaches. the cases show that australian and uk governments both developed strategies against amr while consulting broad arrays of stakeholders across human and animal health, food production, and the research sector. for amr responses, the uk has relied on existing centralised institutions for health governance and established economic ideas to generate accountability and initiatives. australia has mainly relied on its consultative approach while leaving accountability and initiatives to emerge from below the national level. in turn, the uk has arguably made greater progress than australia in the fight against amr. hence, the case comparison suggests that one health, on its own, is insufficient for movement towards effective amr policy. instead, established governance modes and ideational constructs appear important and necessary for such policy to develop. as such, the analysis qualifies the impact potentials of polysemic ideas. polysemy can generate broad attention to solving difficult problems by activating and engaging stakeholders. but even mediated by polysemic ideas, paths to policy remain defined by interests, institutions, and specific ideas. crises, complex problems, and ideas have long been linked in public policy literature. peter hall's ( ) formative work on policy paradigms, for example, suggested that crisis may pave the way for dominant policy paradigms to be usurped by fresh ideas. more recently, ideational scholars have studied cases where paradigm shifts have not followed crises (carstensen ) . this has prompted investigation of subtle modes of ideational change, such as interparadigm shifts (carstensen and matthijs ) , ideational path dependence (baekkeskov ) , and relationships between ideas and forms of power (parsons ) . equally, scholars of 'wicked' problems have studied ideational phenomena, such as framing and discourse (reinecke and ansari ) , learning (termeer et al. ) , and evidence uses (smith ) . more broadly, change rarely occurs without conceptualised alternatives to the policy status quo or ideational links between 'functional problems' and action (vis and van kersbergen ) . within recent literature linking ideas and complex problems, a particular claim stands out: that 'highly ambiguous and polysemic ideas that mean different things to different people are likely to have broader appeal for coalition builders than better-defined, narrower ideas' (béland and cox , p. ; see also skogstad and wilder ) . ideas are often central to political coalitions. in the advocacy coalition framework, actors in policy subsystems rally around shared core beliefs (sabatier ) . however, such coalitions have generally been seen as stable rather than shifting (although see nohrstedt ) . in work on epistemic communities, knowledgeable actors (typically experts) in a field assemble around shared ideas about the nature and causes of problems, and 'a common policy enterprise' related to solving these problems (dunlop ; haas , p. ) . similarly, the recent literature has identified various groups that come together around narrow policy elements, such as problem definitions (e.g. 'problem brokers', knaggård ) or policy tools and techniques ('instrument constituencies') (béland and howlett ; haelg et al. ) . however, while these groupings may be transnational, they are most often focused on ideational agreement between similar kinds of actors, rather than forming coalitions between different powerful interests. coalition building is probably most valuable where several powerful actors are needed to create effective policies and where costs of inaction are high, but agreements about the existence, characteristics, or causes of problems and solutions are difficult to reach. given that such challenges can be seen in cases of complex or 'wicked' problems and transboundary crises, polysemic ideas may be particularly important in such situations. crises convey urgency, uncertainty, and threat to core functions (ansell et al. ) . they are extraordinary, can be unexpected, and challenge the legitimacy of dominant ideas and procedures (boin et al. ; nohrstedt ) . 'wicked' problems are generally thought of in terms of complexity and intractability (rittel and webber ) . although not all crises are complex and not all complex problems will be crises, overlaps are plausible. complex problems suggest risks of future crisis (climate change being an obvious example). where potential crises are identified long before their effects appear, political and economic incentives lead actors to discount the future (levin et al. ). contemporary problems and crises often cross borders, policy sectors, and levels of government, leaving no actor capable of alone responding effectively (ansell et al. ). as such, they can be characterised by uncertainty and fragmentation of authority, and coordination challenges. in béland and cox's ( ) view, polysemic ideas are successful because they allow policy instruments that are potentially divisive on their own to be attached to broader ideas that garner support from diverse stakeholders. it is therefore no coincidence that the 'coalition magnets' they discuss ('solidarity', 'social inclusion', and 'sustainability') deal with poverty, inequality, and environmental protection-three complex and longstanding public policy problems. this argument is also reflected in more recent work emphasising the virtues of more malleable ideas and frames. for example, skogstad and wilder ( ) claim that 'multidimensional ideas' not only help create a 'bandwagoning' effect, but also ensure that opposition remains fragmented. similarly, faling and biesbroek ( ) emphasise the importance of employing multiple frames in building cross-sectoral coalitions. while claims regarding the power of broader or more ambiguous frames are not unfamiliar in public policy scholarship (e.g. baekkeskov on public-private partnership and contracting out; schmidt and thatcher on neoliberalism), this more recent literature highlights potentially significant consequences for attempts to address generally intractable problems: ideas that allow multiple interpretations should not only be seen as links between problem and solution, but also as tools that can help overcome disagreements or mobilise passive actors (béland and cox , p. ). reiterating the key contention, deploying polysemic ideas can create powerful coalitions by attracting diverse powerful actors. this augments the broadly held view that interest groups presenting a united front are more likely to successfully navigate the policy process (baumgartner and jones ) . there is also reason to examine how far polysemic ideas can drive meaningful action on problems characterised by complexity or potential conflicts of interests and values. affected stakeholders will often be drawn from several interest and expert communities. without some means of resolving pre-existing conflicts, a 'big tent' of diverse actors may be little more than a talk shop, with agenda-setting success, but difficulty in policy formulation or decision-making . in addition, having opposing interests 'inside' creates opportunities for opponents of some courses of action to exercise veto or obstruct bargaining. attention from diverse stakeholders is of little value if it does not generate effective coalitions. some participants in broad deliberations could be among those contributing to problems. béland and cox ( ) describe the example of mcdonalds collaborating with the environment defense fund to reduce packaging and waste under the guide of 'sustainability'. but the case is extraordinary rather than representative (cashore et al. ). absent serious action, outcomes of diverse stakeholder collaborations could resemble what mcconnell ( , p. ) calls 'placebo policies': superficial action without tackling the underlying problem. moreover, as béland and cox ( ) describe, mcdonalds saved money from the partnership. but in complex problem areas (such as climate change) we do not know whether all coalition members will gain from the effective solutions. moreover, there is a risk that an emphasis on consensus will lead to avoidance of more intractable issues, in favour of lower hanging fruit (van de kerkhof ) . indeed, stakeholders may conceivably enter the 'tent' in a bid to co-opt policy-making (o'toole and meier ). at the same time, polysemic ideas may predicate themselves on building a broad coalition ('solidarity'-cross-class; 'social inclusion'-cross-class; and as the next section describes, 'one health'-cross-sector, cross-species). this means that the ideas partly derive their legitimacy from maintaining broad coalitions. narrowing of actors involved is therefore difficult. of course, another possibility in relation to complex problems is that there is little need to narrow down the scope of solution sets. given the multi-sectoral, cross-boundary nature of some complex problems (such as transboundary crises), an array of instruments may need to be employed. still, the questions remain of what actually is done, who coordinates these efforts, and who is accountable for setting and reaching goals. solving complex problems may require short-term losses in some places to prevent steeper longer-term pain. and short-term losses may be imposed on actors who do not have prospects for equal or greater long-term gains (i.e. a collective action problem- olson ) . for government, unavoidably driven by short-term incentives, delaying decisions or avoiding blame may seem much more attractive than dealing with these political difficulties. to scope the role of polysemic ideas in actual policy-making, we next investigate the political implications of 'one health', a concept that has become accepted among global and national public health authorities as the key 'approach' to emerging infectious diseases (one health ). universal recognition of one health constitutes a political feat in itself, accomplished at least in part through the efforts of entrepreneurial health professionals (bresalier et al. ; cassidy ) . one health is also a polysemic rather than a specific idea. its core can be stated simply: human, (farm) animal, and (wild) environmental health are interdependent (e.g. world health organization , p. vii). that is, diseases cannot be controlled in one sector only, but must be addressed in all sectors. however, different agencies offer different definitions of one health, which has led some scholars to characterise it as 'an "umbrella concept" for a variety of expert perspectives and disciplinary agendas' (degeling et al. , p. ) . while the need for coordinative action rather than siloing of policy responses is generally recognised, the proverbial devil is in the policy details: what actions? by whom, where, and when? coordinated by whom? funded how? antimicrobial resistance (amr) is an emerging crisis that both fits the basic remit of one health and demonstrates the fundamental challenges in applying it. amr cannot altogether be prevented because microbial species unavoidably evolve towards immunity to antimicrobial agents (e.g. antibiotics) when these agents are in use. any policy response will necessarily involve sectors like human and animal medicine, regulators, and food production. hence, proposed approaches are often multi-sectoral (laxminarayan et al. ; review on antimicrobial resistance ; world health organization ). however, at each stage of specifying actions and policy, polities seeking to adopt and adapt one health to the amr challenge face choices with potentially significant costs (roca et al. ; walsh ) . for instance, contemporary food production is often dependent on antibiotics; eliminating antibiotics can thus threaten farming outputs and raise the prospect of higher food prices. similarly, choices may present more opportunities for some actors than others. for instance, pharmaceutical developers can benefit from policies that boost government subsidies for developing new antimicrobials, while limits on antimicrobial uses may threaten their revenues. specifying the multi-sectoral and multi-jurisdictional amr policies and actions that follow from one health thus has the potential to become intensely contested. moreover, if 'losers' can exercise a veto, then the potential for political settlements on specific policies against problems such as amr becomes more limited. although described as an emerging crisis, amr is an old problem. amr has received several waves of global and domestic policy attention, beginning in the s (podolsky ). at the same time, the current wave of attention to amr both has been closely associated with one health and has led to more sustained attention than in previous eras. one health and renewed problematisation of amr arose separately, but in parallel in the new millennium (gibbs ; kahn et al. ; lee and brumme ; podolsky ) . amr captured policy-makers' attention around . during the mid- s, other public health issues such as pandemic influenza competed for political attention (chien ) . amr then returned to political agendas with greater force in the years after . using the who as an example, the organisation has made varying levels of effort against amr in recent decades. to illustrate, mentions of amr in who publications peaked between and , declined between and , and increased during - to higher levels than in preceding years (see online appendix ). the match of amr and one health happened during this recent period of renewed political attention to amr. in , the world health organization (who) released a six point 'policy package' to guide national-level amr policy-making with no mention of one health (world health organization ). the first who document on amr that mentioned one health was published in (online appendix ). just years later, the who's core guidance on amr policy, the global action plan (gap), was framed explicitly as part of a 'one health approach' (world health organization : vii). world leaders meeting in the un general assembly (unga) on september made a political declaration on amr stating that 'without an effective one health approach', amr is likely to have 'massive social, economic and global public health repercussions' (united nations general assembly ). hence, within a few short years, the one health approach had become the guiding frame for global response to the amr problem. the recent political attention to amr appears to have spurred significant response action. the who's gap (and similar guidance from the un agencies for animal health and agriculture) and the unga declaration called on countries around the world to articulate national action plans (naps) for dealing with amr. since , the number of naps has increased rapidly. however, to understand the role of one health as a polysemic idea, we must examine two elements of its role in shaping responses to amr: firstly, whether it has helped to generate response coalitions and secondly, whether government responses to amr have made greater headway than they might have in the absence of the one health idea, for instance, by mobilising multiple sectors to act or progressing response across all sectors that contribute to the amr problem. the next section analyses one health's role in amr policy-making by comparing recent developments in australia and the uk. both countries have long had relatively highly developed regulation of antibiotic use and other contributors to amr in their health and food production systems. however, in the current wave, the uk was among the first to take renewed action (indeed, by some accounts it spurred the renewed drive; podolsky ), and with one health as just one among several ideas used. in contrast, australia's new amr strategy was developed one or years later and explicitly framed by the one health perspective. as such, while there are no available cases in which one health is absent from recent amr policy-making, comparison of these two cases allows an opportunity to consider what work it did in these countries' amr policy processes. the case analyses assess whether the following two expectations are fulfilled: . introducing the one health idea rallied stakeholders to support amr response. . one health made effective amr policy more likely. while many actors have been consulted on and tasked with amr response in both australia and the uk, the available evidence on these processes suggests resolving amr has been more strongly associated with the idea of one health in australia than in the uk. in australia, the national government held a one health antimicrobial resistance colloquium in july the department sought feedback on its initial draft of the strategy. as such, both governments called on a wide range of sectors and stakeholders as they developed plans to address amr nationally. calling on many kinds of stakeholders is consistent with the one health approach. many stakeholders heeding both calls is consistent with one health functioning as an amr attention 'magnet'. notably, governments called on stakeholders to assemble, rather than stakeholders coalescing spontaneously around their common interest in stopping amr. the stakeholders might have heeded calls to consultation simply due to their government's authority rather than one health's persuasive appeal. in turn, while calling on many stakeholders was consistent with a one health approach, the two governments' motivations for action against amr appear differently linked to one health. the uk's published strategy against amr mentions one health five times, in the context of a broad need for collaboration rather than linked to specific initiatives (department of health and department of environment, food & rural affairs , p. ). australia's published strategy is a document of very similar length and content to the uk's (department of health and department of agriculture ). it mentions one health twenty times, particularly in relation to specific initiatives on public and professional awareness and disease surveillance. the uk's amr strategy describes government's role as 'leadership, stewardship and strategic direction…by holding national bodies to account and ensuring different parts of the system work properly together' (department of health and department of environment, food & rural affairs , p. ). it also assigns all proposed actions to a government department or agency (uk government ). this implies that the uk tackles amr through central leadership coupled with agency and departmental accountability. one health in the form of horizontal collaboration between sectors is absent from this strategy. australia's amr strategy emphasises multi-sectoral collaboration and one health in each of its seven priority areas. in turn, australia's report on implementation categorises separate actions in relationship to one health. the australian approach has emphasised communication, delegation, and consensus on amr. from the outset of planning for the national amr strategy, the australian process aimed to be 'cooperative and designed to benefit all parties' (australian commission on quality and safety in health care , p. ), with the one health approach to action providing 'an opportunity to find common ground across sectors' (australian commission on quality and safety in health care , p. ). in turn, of the actions listed in the implementation plan are delegated to bodies that are not federal government departments or agencies (department of health and department of agriculture ). congruent with the mutual interdependency inherent to the one health concept, distributed initiative and voluntary collaboration appears to be how australia manages amr response. this evidence on amr strategy development and implementation is broadly consistent with the first contention about polysemic ideas, which is that they are capable of rallying otherwise contending interests to agree on a public problem. both governments rallied numerous stakeholders to planning consultations. notably, governments were central in both cases. in turn, australia's amr strategy asked for action from non-governmental actors, with few explicit accountability mechanisms or central controls on who did what. in contrast, the uk's amr strategy suggests that embracing one health was not essential in creating amr response. rather, the uk's strategy largely articulated amr response as a multi-sectoral, but centralised endeavour that bears easy similarity to standard uk governance. we return to the meaning of these differences in the discussion section below, after considering the impact of one health on the contents of policy responses in more detail. close examination of the national strategies and subsequent achievements suggests that 'big tents' associated with wide consultation have resulted in more than talk. australian and uk implementation plans for the amr strategies outline hundreds of actions, in many cases involving collaboration between government and various stakeholders (department of health and department of agriculture ; uk government ). responses developed during the current, one health-linked wave of attention to amr are also more extensive than responses that emerged during the early s (department of health ; joint expert advisory committee on antibiotic resistance ). according to annual self-assessment surveys of countries conducted by un agencies starting in - , countries including australia and the uk have developed amr naps in line with the global action plan and adopted integrated, multi-sectoral approaches to implementation. the un surveys allow systematic comparison of australian and uk responses across six major categories (public and professional awareness; education and training; stewardship ; infection prevention and control (ipc); surveillance of am usage; and surveillance of am resistance). in turn, response scores in these categories range from no action ( ) to highly developed activity ( ) (see online appendix ). these self-reported data yield indications about national amr responses. both countries report considerably more activity in human health than in veterinary health and agriculture. to realise a one health approach, both would need considerably more intersectoral coordination. however, the uk has reported higher scores than australia across four of the six areas, slightly more similar policy scores between sectors, and higher average scores for each of the three sectors. this indicates a more advanced and coordinated response to amr than australia has achieved. as previously described, uk amr strategy relies less than the australian on the one health framing. this potentially sets our expectation that polysemic ideas ease policy-making at odds with actual responses. however, the gap between human health and other sectors is also variable across areas. in the uk, the largest gaps in response scores between sectors are in awareness and ipc, while the australian responses indicate substantial gaps in the development of integrated surveillance programmes. qualitative analysis of national implementation reports generally confirms the broad patterns indicated by the un surveys (see online appendix). both countries have implemented an array of actions, particularly in human health. to promote more appropriate uses of antimicrobials, they run nationwide amr awareness campaigns targeted at healthcare providers and the public. both have also updated accreditation standards, educational materials, and curricula for healthcare providers (australian commission on safety and amr response has also taken different qualitative turns in the two countries. in several areas of human health, the uk has taken more initiatives than australia. these include provision of detailed localised data on prescribing and resistance to health providers, monitoring of public awareness, and the use of financial incentives for providers to make improvements to practice. in turn, australia appears to have placed more emphasis on coordination between sectors in relation to awareness and ipc, including across human and animal sectors through the commission on quality and safety in health care, and the australian government's 'one health amr' website that provides information for consumers, food producers, and health professionals. a significant area of difference between the countries is sectoral levels of amr surveillance. both countries have amr surveillance systems for human health with regular reporting. but the uk has more developed surveillance than australia in the other sectors. through a mandatory eu programme and monitoring by its own animal and plant health authority, the uk has comprehensive surveillance of resistance in animals and collects data on sales of antimicrobials for animals (public health england ) . this has enabled a cross-sector 'targets task force' to establish voluntary usage targets for food producers (uk government , pp. - ) . in contrast, australia has lagged in animal health surveillance. progress has stopped at development proof-of-concept surveillance programmes with industry bodies like meat and livestock australia. hence, as of a progress report, australia describes integrated one health surveillance as a 'long-term goal' (department of health and department of agriculture and water resources , p. ). comprehensive amr also include research and development, and international engagement (these are not measured by the un survey). comparison of national implementation documentation indicates that the uk has placed more emphasis than australia on funding research towards new drugs, therapeutics, and diagnostics, and on the need for international action. in its - amr strategy, the uk government claims to have 'invested more than £ million in research and development on amr' since , through various channels, including the uk global amr innovation fund and the uk-china amr innovation collaboration (uk government , p. ). the uk has also supported amr surveillance in lower-and middle-income countries, by contributing £ million to a private foundation (uk government , p. ). in , it hosted a global leaders event on one health and amr (uk amr strategy high level steering group , p. ). moreover, its implementation strategy nominated a un political declaration on amr as a national aim, and the uk's chief medical officer was a crucial advocate for renewed global action (podolsky ). australia has not contributed resources to r&d or international initiatives at the same scale, even when adjusting for its relatively smaller economy. the progress review (department of health and department of agriculture and water resources , p. ) notes that it has funded million aud worth of research into various aspects of amr, and states that it 'remain [s] open to contributing to new research initiatives'. however, aside from contributing $ million through three product development partnerships, largely focused on tuberculosis and malaria in the asia-pacific region, there is little evidence of concrete action (department of health and department of agriculture and water resources , p. ). one health has clearly influenced current amr-related policy-making. the match-up of amr and one health after , growing global policy attention to amr in the same period, and escalating national amr initiatives in the wake of the gap and unga statement collectively support that deployment of polysemic ideas can be associated with more policy-making on complex problems. in addition, australia and the uk both appear to have attempted coordinated, multi-sectoral approaches to the amr challenge, consistent with the one health idea. moreover, development of policy is still ongoing. as such-where responding to a problem requires diverse coalitions-the analysis suggests that framing responses around an attractive polysemic concept can help draw actors together in initial deliberative stages of policy formulation. however, the comparison of amr policy-making in australia and the uk suggests limitations on the reach of one health. the uk and australia have taken different interpretations of government's part in amr response. the uk government appears to use centralised governance with delegation to and reporting back by multiple departments. australia's government seems to merely convene stakeholders while leaving initiatives, action, and even much of the reporting to local or private actors. in turn, as described, indications are that uk responses to amr have been more extensive and integrated across sectors than australian. we are not suggesting that amr policy-making in either case has been a failure. however, a fundamental claim of one health activism is that rethinking established (siloed) modes of policy is critical for success. as such, asymmetries, particularly those in the australian case, given the relatively stronger emphasis on the one health concept observed there, allow us to identify some of the limits of a polysemic framing. the contrasts between the cases first suggest that institutional context may have so far been more important to amr response than the one health idea. the integrated nature of the uk's national health service lends strong government direction to uk health governance, and the uk reports making particularly strong progress against amr in the human health sector. while australia also reports making reasonable progress against amr in human health, it faces institutional barriers to intersectoral coordination that are largely unrelated to one health. these include a mixed public-private hospital system, the authority and funding of which are also divided between the national and state governments (duckett ) . the presence of such divisions of authority align well with australia's general approach to amr, which is to define government's role as 'working with stakeholders' and forming 'new partnerships' (department of health and department of agriculture , p. ), and its emphasis on specific actions in this domain, such as the development of a 'one health amr website', which is mentioned repeatedly in strategic and review documents. amr responses' dependency on such institutional factors is made more plausible by looking closely at surveillance programmes. surveillance of antimicrobial drug use and resistance are fundamental components of an effective response. without understanding how medicine is used and patterns of resistance, programmes to improve stewardship and applications of such agents are inhibited. yet, as already discussed, in australia the most obvious disparity between sectors is in its surveillance programmes. progress has been much slower in animal health and food production than in human health despite the strong presence of one health discourse in discussion of the need for comprehensive surveillance. in contrast, the uk's success with regard to surveillance is partly due to its participation in european union (eu) programmes that predate the conceptual pairing of amr and one health (department of health and department of environment, food & rural affairs , p. ). the uneven australian surveillance system may also speak to our contention that diverse coalitions can hinder certain initiatives because some resist policy change to protect their interests. for example, in submissions to a senate hearing on australia's response to amr, the australian chicken meat federation and animal health australia emphasised that surveillance should be conducted only in proportion to risk, with the chicken federation suggesting that surveillance every years would be sufficient (finance and public administration references committee , p. ). maintaining a high engagement process that emphasises stakeholder consent seems likely to help stakeholders (in this case australia's meat industry) protect their interests more than leaving government to mandate changes (such as more amr surveillance). finally, the case analyses also suggest something of a paradox regarding polysemic ideas. in the academic literature, one health is often presented as an interdisciplinary paradigm or unifying frame that can be applied to various global health, environmental, social, and economic issues (kingsley and taylor ) . however, in policy-making terms it is usually construed more narrowly as an appeal to multi-sectoral collaboration among professional stakeholders. this can be observed, for example, even in the way in which international progress on amr is measured (exemplified previously). yet, multi-sectoralism alone cannot solve amr, nor are useful responses to amr necessarily multi-sectoral. when one health and amr were initially paired, uk policy-makers had already hit upon a clear problem framing, what wernli et al. ( ) call 'amr as an innovation issue'. rather than linking amr to poor coordination between sectors, amr is often described as a 'market failure' linked to slowing development of new antimicrobials by pharmaceutical and chemicals businesses. key uk government documents on amr, including the chief medical officer's annual report and the national strategy, discuss not only the 'economic burden' of amr, but also economic opportunities in new diagnostics and therapeutics (davies examine and boost awareness of the economic issues surrounding the development, spread and containment of antimicrobial resistance (amr), with a particular focus on…research and development of new antimicrobial drugs. in contrast, equivalent australian documents mention only that the problem has economic 'dimensions', and relegate economic impact analyses to the future (australian commission on quality and safety in health care , p. x; department of health and department of agriculture , p. ). this difference aligns with the previously described disparity between uk and australian efforts on amr-related r&d and international engagement. one health can work with other ideas. some academic literature on one health takes economic dimensions of problems and responses into account (see mackenzie et al. ). however, an approach like the uk's would be inconsistent with the australian government's role in advancing a 'one health solution' by coordinating stakeholders, rather than direct intervention to correct market failure. like the plausible importance of each institutional context, the contrast between economic ideas illustrates that one health on its own offers little actionable guidance for amr response. supplementing the polysemic idea with more specific problem and solution framings may therefore provide pathways to action. contemporary discussions of public policy are often characterised by frustration with the difficulties that complex problems and emerging crises pose for political systems. in search of broad agreement, policy-makers and scholars have turned to broad concepts, such as 'sustainability' or 'social inclusion' in relation to environmental and social problems. this article has probed the promises and pitfalls of these 'polysemic' ideas, supporting that they can help bring stakeholders to the table, but also showing that movement towards making effective policies can require favourable institutional conditions and specific ideas about what to do. particularly at the agenda-setting stage, there are good reasons for advocates to present a united front of stakeholders and to foster cooperation between otherwise siloed sectoral interests. however, our analysis of the linkage between one health (a polysemic concept par excellence) and amr response (an emerging global crisis) in australia and uk also suggests that the rallying of stakeholders around a polysemic concept is of limited value. while both countries have responded to amr with national strategies and more specific policy initiatives, particularly in human health, australia appears to be making less progress than the uk in critical areas such as surveillance in the veterinary health and food sectors. moreover, australia's primary one health thrust appears to have been to assemble stakeholders for talks. in contrast, the uk government has assigned departmental responsibilities for amr policy implementation, coupled with accountability targets. it is too soon to tell which country is doing better in amr response. instead, the analysis suggests that rather than the polysemic idea of one health, institutions (e.g. uk centralised government v australia's multi-level federal system) and actionable paradigms (e.g. market failure and well-understood strategies to overcome it) may be more essential factors driving amr response. governments may need to impose on the interests of stakeholders or act as 'gatekeepers', narrowing the range of possible solutions and ensuring accountability. while this governance can complement deployment of polysemic concepts like one health, the ideational emphasis on inclusiveness can mean that real politics is overlooked: sometimes losers need to be shut out to reach a political bargain. moreover, where polysemic ideas become dominant problem and solution framing, the importance of actionable ideas may be ignored. therefore, while malleable concepts are likely to continue to draw wide stakeholder agreement in similar cases, for meaningful and, above all, sufficient responses to be implemented, such agreement is only a beginning. managing transboundary crises: identifying the building blocks of an effective response system report of the australian one health antimicrobial resistance colloquium natio nal-safet y-and-quali ty-healt h-servi ce-stand ards-secon d-editi on issue framing and sector character as critical parameters for government contracting-out in the uk same threat, different responses: experts steering politicians and stakeholders in h n vaccination policy-making agendas and instability in american politics ideas as coalition magnets: coalition building, policy entrepreneurs, and power relations how solutions chase problems: instrument constituencies in the policy process governing after crisis: the politics of investigation, accountability and learning one health: the theory and practice of integrated health approaches institutional bricolage in times of crisis of paradigms and power: british economic policy making since thatcher designing stakeholder learning dialogues for effective global governance one health? building an interdisciplinary bandwagon at the interfaces of animal health, human health and the environment how did international agencies perceive the avian influenza problem? the adoption and manufacture of the 'one world, one health' framework infections and the rise of antimicrobial resistance. london: department of health a delphi survey and analysis of expert perspectives on one health in australia dh uk antimicrobial resistance strategy and action plan the health and social care act : code of practice on the prevention and control of infections and related guidance responding to the threat of antimicrobial resistance: australia's first national antimicrobial resistance strategy - . canberra: author australia's first national antimicrobial resistance strategy the australian health care system epistemic communities cross-boundary policy entrepreneurship for climate-smart agriculture in kenya monitoring global progress on addressing antimicrobial resistance: analysis report of the second round of results of amr country self-assessment survey the evolution of one health: a decade of progress and challenges for the future introduction: epistemic communities and international policy coordination. international organization the role of actors in the policy design process: introducing design coalitions to explain policy output policy paradigms, social learning, and the state: the case of economic policy-making in britain wicked problems: implications for public policy and management streams and stages: r econciling k ingdon and policy process theory the use of antibiotics in food-producing animals: antibiotic-resistance bacteria in animal and humans. canberra: author emerging infections: a tribute to the one medicine, one health concept one health: competing perspectives in an emerging field the multiple streams framework and the problem broker extending the cure: policy responses to the growing threat of antibiotic resistance operationalizing the one health approach: the global governance challenges overcoming the tragedy of super wicked problems: constraining our future selves to ameliorate global climate change one health: the human-animalenvironment interfaces in emerging infectious diseases: the concept and examples of a one health approach understanding policy success: rethinking public policy the politics of crisis policymaking: chernobyl and swedish nuclear energy policy desperately seeking selznick: cooptation and the dark side of public management in networks the logic of collective action: public goods and the theory of groups ideas and power: four intersections and how to show them the evolving response to antibiotic resistance uk one health report: joint report on human and animal antibiotic use, sales and resistance taming wicked problems: the role of framing in the construction of corporate social responsibility tackling drug-resistant infections globally: final report and recommendations. london: author dilemmas in a general theory of planning the global threat of antimicrobial resistance: science for intervention. new microbes and new infections an advocacy coalition framework of policy change and the role of policy-oriented learning therein resilient liberalism in europe's political economy strangers at the gate: the role of multidimensional ideas, policy anomalies and institutional gatekeepers in biofuel policy developments in the usa and european union beyond evidence based policy in public health: the interplay of ideas governance capabilities for dealing wisely with wicked problems review on antimicrobial resistance uk year antimicrobial resistance (amr) strategy - : annual progress report uk year antimicrobial resistance (amr) strategy - : annual progress report and implementation plan government response to the review on antimicrobial resistance. london: author tackling antimicrobial resistance - : the uk's five-year national action plan. london: author political declaration of the high-level meeting of the general assembly on antimicrobial resistance making a difference: on the constraints of consensus building and the relevance of deliberation in stakeholder dialogues towards an open functional approach to welfare state change: pressures, ideas, and blame avoidance a one-health approach to antimicrobial resistance mapping global policy discourse on antimicrobial resistance world health day policy package to combat antimicrobial resistance global action plan on antimicrobial resistance. geneva: author acknowledgements versions of this paper were presented and discussed at the 'ideas and crisis response' workshop held at the university of melbourne in december and the public policy network meeting at the university of queensland in january . we are very grateful to the organisers and participants for feedback on earlier drafts.funding n/a. key: cord- -ig nwtmi authors: nan title: th european conference on rare diseases & orphan products (ecrd ) date: - - journal: orphanet j rare dis doi: . /s - - - sha: doc_id: cord_uid: ig nwtmi nan theme: when therapies meet the needs: enabling a patient-centric approach to therapeutic development. background: rare diseases (rd) often result in a wide spectrum of disabilities, on which information is lacking. there is a need for standardised, curated data on the functional impact of rd to facilitate the identification of relevant patient reported/patient centered outcome measures (proms/pcoms) as well as for the use of validated quality of life instruments based on functional outcomes. to address these issues, orphanet is partnering with mapi research trust (mrt) in order to connect orphanet to proqolid ™ , mrt's proms/pcoms database, through disease codes. visit orphanet at www.orpha .net. methods and materials: the orphanet functioning thesaurus (oft) is a multilingual controlled vocabulary derived from the icf-cy. a subset of rd present in the orphanet nomenclature is annotated with the oft, with the addition of attributes for each functional impact (frequency, severity, and temporality) for each specific rd. annotations result from structured interviews with clinical experts, medical-social sector care providers, and patient organisations. in order to link proqolid ™ data with orphanet disability data, the taxonomy used to qualify rds in proqolid ™ was reviewed and mapped to orphanet's. all proms developed for rds were identified, and all products approved by the fda and ema from to with an orphan drug designation (odd) and a pro claim were listed. results: the orphanet knowledge base contains over rd, of which rd have been assessed for their functional consequences, of which rd have been annotated: the remaining rd were annotated, after discussions with medical experts, as either being highly variable, non-applicable or resulting in early-death. of the most prevalent rare diseases, have been annotated according to their functional consequences. rds had a prom (n = ) in pro-qolid ™ and . % of odd included a pro claim. the rds with the most prom were sickle cell anemia, spinal cord injuries, cystic fibrosis, all forms of hemophilia a and b and duchenne muscular dystrophy. prom used in labels were primarily focusing on symptoms ( %), rarely on functioning ( %) or health-related quality of life ( %). conclusions: linking these two databases, and providing standardised, curated data, will enable the community to identify proms/ pcoms for rd, and is the first step towards validated quality of life instruments based on functional outcomes. and eurordis. some patient organisations distributed the survey too more common disease patients as well, e.g. hashimoto's disease, and these responses were excluded. the survey asked patients to give suggested topics (i.e. fertility, heritability, tiredness, daily medicine intake, sleep quality, physical discomfort, and ability to work, partake in social life, and sports) a priority score and to suggest their own topics for research in open fields. open field responses were analysed with topic modelling and klipp-analysis. results: after exclusion of responses from more common endocrine disease patients, survey responses were analysed. most responses were received from northern ( %) and western europeans ( %), while southern ( %) and eastern europe ( %) were underrepresented. of the suggested topics respondent were most interested in research concerning the ability to work and participate in social life, and on tiredness. when patients were open to suggest their own topics, common responses included long-term side effects of drugs and quality of life. however, priorities differed between disease groups. for example, adrenal, pituitary and thyroid patients were more interested in research concerning tiredness than others. conclusion: with this survey endo-ern is provided with a large sample of responses from european patients with a rare endocrine condition, and those patients experience unmet needs in research, though these needs differ between the disease groups. the results of this study should be incorporated by clinical experts in the design of future studies in the rare endocrine disease field. purpose: when developing a health technology that requires clinical studies, developers institute working relations with clinical investigators. patient representatives can also create and manage advisory boards with product developers. this was of high utility in the s, in the development of products to treat hiv infection. inspired by this model, the european organisation for rare diseases (eurordis) proposes the eurocab programme to facilitate a two-way dialogue between patient representatives and medicine developers. as of , disease-specific cabs exist of approximately members each and others are being formed. methods: eurordis invites developers to sign a charter for collaboration with patients in clinical research, and provides guidelines together with a mentoring and training programme for patient networks. cabs help set the agenda with the developer, work on topics as diverse as study design, feasibility, informed consent and site selection, qol and proms, and organize the meetings. discussions also cover compassionate use, pricing, relative efficacy, etc. meetings last for to days with sessions with different developers, all under confidentiality. there are regular between-meeting teleconferences for trainings and action plan updates, and some cabs have instituted working groups on access, psychological support, etc. the collaboration is evaluated via a post-meeting survey send to both cab members and medicine developers. in addition, cabs have recently started to monitor outcomes of the meeting and progress towards their goals with a tracker tool. results: the results of the first surveys from distinct cab meetings with companies show that this form of shared decision-making is valuable as well as ethical for both parties. we have seen that working relations always continue, even when discussions become heated. all involved show interest in the co-creation possibilities of such collaboration and we look forward to seeing progress and change via the tracker. conclusions: monitoring and evaluation are crucial to understand whether and how the cabs are making an impact on medicine development. demonstrating impact is challenging because of the contextualized nature and complexity inherent to patient engagement collaborations in research design. eurordis is working within para-digm on our monitoring and evaluation strategy, focusing on improving its comprehensiveness and including multi-stakeholder perspectives. our current experiences show that the eurocab programme, with collective thinking and exchange between patients and a collaborative mentality from both sides, ensures high-quality and constructive dialogue with researchers and developers and can eventually inform both hta and regulatory decision-making (fig. ) . we have started to work on the metrics of markers of success. purpose: the french national network for rare sensory diseases sensgene launched in a -min motion design video ( fig. ) aiming at guiding healthcare professionals to welcome visually impaired patients in the hospital. this educational video was created to address patients' expectations and improve their experience in the network's hospital. the european reference network for rare eye diseases (ern-eye) collaborated on the project and created an english version of the video in order to distribute it widely in europe. method: sensgene worked on this project with two big french associations of visually impaired people: fédération des aveugles et amblyopes de france and fédération des aveugles alsace lorraine grand est. more than french patients' associations actively contributed to the project through five focus groups (workshops) which collected testimonies and gathered the needs of visually impaired persons and health-care professionals (fig. ). an evaluation was made by the independent body ipso facto: health professionals answered to a survey before and after viewing the video. results: the video deals with common situations in the delivery of care activities for different types of visual impairment: reception in a hospital center, consultations, moves and orientation in a hospital room (fig. ) . this fits perfectly with the needs of the patients reported in the focus groups. besides, the evaluation showed that % of them improved their knowledge on the topic. background: traditional appraisal and reimbursement approaches such as cost/qaly are increasingly recognised as being potentially unsuitable for rare disease treatments (rdts). approaches to appraising rdts vary across countries, from the same processes used for all medicines, to those completely separate from the standard, to adapted standard processes with greater willingness to pay (wtp). this study examines the impacts of standard versus special appraisal processes for specific rdts in selected countries. methodology: a case study analysis was conducted in which countries with a variety of rdt appraisal processes were selected, along with two rdts representative of the following criteria: rare/ultra-rare treatment, affecting child/adult, cancer/non-cancer, life-threatening/disabling. public hta reports for each country's appraisal of the selected rdts were retrieved and used to extract information into predesigned templates, which allowed for systematic comparison of the rdt processes across countries to compare and exemplify the impact of the different processes. results: reports from belgium, england, france, germany, u.s., italy, lithuania, netherlands, poland, romania, scotland, slovakia, and sweden were selected for spinraza and voretigene. characteristics of each country's process were extracted, including special reimbursement for rdts, special rdt committees, economic evaluation modifications, greater wtp, quality of evidence flexibility, additional considerations, etc. special and standard processes seemed to have different impacts on the appraisal of rdts. special processes more consistently managed rdt issues such as evidential uncertainty and higher icers. standard processes sometimes informally applied some of the characteristics included in special processes, such as broader consideration of value. conclusions: comparing case study country examples of rdt appraisal exemplified the complexity of these processes. special processes were more consistent in managing the challenges in rdt appraisal than standard processes. practical application: findings suggest a need for adapted approaches for rdt appraisal, to facilitate management of associated challenges and more consistent decision-making. estimating the broader fiscal impact of rare diseases using a public economic framework: a case study applied to acute hepatic porphyria (ahp) mark p. connolly , background: the aim of this study was to apply a public economic framework to evaluate a rare disease, acute hepatic porphyria (ahp) taking into consideration a broad range of costs that are relevant to government in relation to social benefit payments and taxes paid by people with ahp. ahp is characterized by potentially life-threatening attacks and for many patients, chronic debilitating symptoms that negatively impact daily functioning and quality of life. the symptoms of ahp prevent many individuals from working and achieving lifetime work averages. we model the fiscal consequences for government based on reduced lifetime taxes paid and benefits payments for a person diagnosed aged experiencing attacks per year. materials & methods: a public economic framework was developed exploring lifetime costs for government attributed to an individual with ahp in sweden. work-activity and lifetime direct taxes paid, indirect consumption taxes and requirements for public benefits were estimated based on established clinical pathways for ahp and compared to the general population (gp). results: lifetime earnings are reduced in an individual with ahp by sek . million compared to the gp. this also translates to reduced lifetime taxes paid of sek . million for an ahp individual compared to the gp. we estimate increased lifetime disability benefits support of sek . million for an ahp individual compared to gp. we estimate average lifetime healthcare costs for ahp individual of sek . million compared to gp of sek . million. these estimates do not include other societal costs such as impact on caregiver costs. conclusions: due to severe disability during the period of constant attacks, public costs from disability are significant in the ahp patient. lifetime taxes paid are reduced as these attacks occur during peak earning and working years. the cross-sectorial public economic analysis is useful for illustrating the broader government consequences attributed to health conditions. ethics approval: the study results described here are based on a modeling study. no data on human subjects has been collected in relation to this research. the european cystic fibrosis (cf) society patient registry collects demographic and clinical data from consenting people with cf in europe. the registry's database contains data of over , patients from countries. high quality data is essential for use in annual reports, epidemiological research and postauthorisation studies. methods: a validation programme was introduced to quantify consistency and accuracy of data-input at source level and verify that the informed consent, required to include data in the registry, has been obtained in accordance with local and european legislation. accuracy is defined as the proportion of values in the software matching the medical record, consistency as definitions used by the centre matching those defined and required by the registry. data fields to verify: demographic, diagnostic, transplantation, anthropometric and lung function measurement, bacterial infections, medications and complications. the number of countries to validate: % of the total countries/year. in the selected country ≥ % of the centres should be visited and - % of the data validated. results: in , ten out of centres ( %) in countries (austria, portugal, slovakia, switzerland) with ≥ % of all patients in their countries were selected. in a day visit, the data of the registry were compared with the medical records, the outcomes and recommendations discussed, and a final report provided. demographic, diagnostic and transplant data were checked for patients ( %*), clinical data for patients ( %*) ( data). challenges were: informed consent, mutation information (genetic laboratory report missing), definitions interpretations. see fig. for the results. conclusion: the registry's data is highly accurate for most data verified. the validation visits proved to be essential to optimise data quality at source, raise awareness of the importance of correct informed consent and encourage dialogue to gain insight in how procedures, software, and support can be improved. *of the total patients in these countries. background: people with duchenne muscular dystrophy (dmd) adopt compensatory movement patterns to maintain independence as muscles get weaker. the duchenne video assessment (dva) tool provides a standardized way to document and assess quality of movement. caregivers video record patients doing specific movement tasks at home using a secure mobile application. physical therapists (pts) score the videos using scorecards with prespecified compensatory movement criteria. objective: to gather expert input on compensatory criteria indicative of clinically meaningful change in disease to include in scorecards for movement tasks. approach: we conducted rounds of a delphi panel, a method for building consensus among experts. we recruited pts who have evaluated ≥ dmd patients in clinic and participated in ≥ dmd clinical trials. in round , pts completed a preliminary questionnaire to evaluate compensatory criteria clarity and rate videos of dmd patients performing each movement task using scorecards. in round , pts participated in an in-person discussion to reach consensus (≥ % agreement) on all compensatory criteria with disagreement or scoring discrepancies during round . results: of the pts, % practiced physical therapy for ≥ years, % provided physical therapy to ≥ dmd patients, and % participated in ≥ dmd clinical trials. of version compensatory criteria, ( %) were revised in round . of version compensatory criteria, ( %) were revised in round . the pts reached % agreement on all changes made to scorecards during the in-person discussion except the run scorecard due to time restrictions. a subset of the panel ( pts) met after the in-person discussion and reached consensus on compensatory criteria to include in the run scorecard. conclusion: expert dmd pts confirmed that the compensatory criteria included in the dva scorecards were appropriate and indicative of clinically meaningful change in the disease. introduction: fifty percent of rare disease cases occur in childhood. despite this significant proportion of incidence, only % of adult medicines authorised by the european medicines agency (ema) completed paediatric trials [ , ] . as a result, many clinical needs are left unmet. various factors compound the development of treatments for paediatric rare diseases, including the need for new clinical outcome assessments (coas), as conventional endpoints such as the minute walking test ( mwt) have been shown to not be applicable in all paediatric age subsets, [ ] and therefore may not be useful in elucidating patient capabilities. coas are a well-defined and reliable assessment of concepts of interest, which can be used in adequate, well-controlled studies in a specified context. coas capture patient functionality and can be deployed through the use of wearable sensor technology; this feasibility study presents data obtained from patients with paediatric rare diseases who were assessed with this type of technology. methods: niemann pick-c (np-c) (n = ) and duchenne muscular dystrophy (dmd) (n = ) patients were asked to wear a wrist-worn wearable sensor at home for a minimum of weeks. feasibility was assessed qualitatively and quantitatively, with data captured in minute epochs, measuring the mean of epoch's with the most steps over a month (adm), average daily steps (ads), average steps per minute epoch (ade) (table ) and reasons for non-adherence (table ) . no restriction in the minimum number of epochs available for analysis were applied, and all patient data analysed. results: discrepancies in ambulatory capacity were observed between np-c and dmd patients overall, with np-c patients covering greater distances and taking more steps daily. qualitative assessment of both patient groups highlighted their relationships with the technology, which in turn detailed adherence. some patients exhibited behavioural issues which resulted in a loss of data and low engagement. conclusions: the wearable sensor technology was able to capture the ambulatory capacity for np-c/dmd patients. insights into disease specific parameters that differed were gained, which will be used for developing the technology further for use in future trials. additional work is required to correlate the wearable device data with other clinical markers, however the study displays the feasibility of wearable sensors/apps as potential outcome measures in clinical trials. background: neonatal surgery is decentralized in germany. in there were departments of pediatric surgery that treated % of the abdominal wall defects with an average case load of less than per unit [ ] . patient organizations stress the importance of quality measurements for the care of children with rare diseases. study plan: currently, there is no nationwide data collection regarding the short term and long term care of patients with congenital malformations, who often need surgery during the first weeks of life. the german society of pediatric surgery, which covers almost all of the german pediatric surgical units, has initiated the work of creating a national patient registry (kirafe) for the following congenital malformations: malformations of the gastrointestinal tract, the abdominal wall, the diaphragm, and meningomyelocele. the development of the registry involves three different patient organizations and health care professionals from all over germany. the registry will be set up in based on the open source registry system for rare diseases (osse). the primary objective of the registry is the measurement of quality attributes of rare congenital malformations. furthermore, the registry will facilitate recruitment of patients to clinical trials. it will also serve as a basis for policy making and planning of health and social services for people with rare disorders. informed consent will be obtained from the participants. the registry will include core data, mainly comprising information on the set of malformations of each patient. each malformation will then prompt further different modules for data collection. this modular structure offers the greatest possible flexibility for the documentation of patients with more than one congenital malformation. data will be collected by health care professionals. results: since the start of the preparation individuals, either working in one of hospitals or being member of one of the three patient organizations, have contributed in the ongoing activities. the registry is listed in the european directory of registries (erdri) [ ] . ethical approval was obtained, financial resources were secured. in , german hospitals and three non-german hospitals confirmed their intention to document their patients within the registry. conclusion: the registry is an example for a nationwide collaboration with the goal to optimize the quality of care for a patient group with rare diseases. is a collaboration between cf europe and five pharmaceutical companies (to date). through biannual meetings, we aim to institute a longterm educational collaboration with companies with an interest in cf. membership of industrial partners is dependent upon adherence to the cfrtoc code of conduct and a financial contribution for cf europe to fulfil its missions. common objectives include access to information. one strong example, applicable even beyond rare diseases, is the need for improved communication regarding clinical trials (cts) which has been inconsistent and often difficult to understand. from , the new european ct regulation / will oblige sponsors to share ct results through lay summaries. to help move this initiative forward, cf europe, with the active support of the cystic fibrosis trust, is collaborating with the european cystic fibrosis society-clinical trials network (ecfs-ctn) and cfrtoc members to establish a glossary of relevant cf terms. it will be freely available so that all stakeholders can systematically use it in patient-friendly scientific summaries and wider communication. in a pilot project, people with cf and patient associations, together with industrial partners will shortlist terms. these will be defined by lay members and subsequently subjected to the study and approval of the legal department of participating companies. provided this process is successful, we aim to create approved definitions by the end of . cf europe and ecfs-ctn intend to advertise the use of this glossary online and through communications at scientific events. national patient organisations will be further encouraged to provide translations in their national language. alkaptonuria (aku, ochronosis) is an inborn metabolic disease, resulting in the accumulation of the metabolic intermediate homogentisic acid (hga). oxidation of hga by air or within connective tissue causes darkening of the urine, pigmentation of eyes and ears, kidney-and prostrate-stones, aortic stenosis, but most severely an early onset of arthritis called ochronotic arthropathy (ochronosis) due to deposition in the cartilage. ochronosis is very painful, disabling and progresses rapidly. starting in the thirties with the spine and affecting large joints in the forties, patients frequently require joint replacements in their fifties and sixties [ , ] . like many of the rare diseases, aku-patients undergo a long odyssey of several years until their diagnosis. the german aku-society "deutschsprachige selbsthilfegruppe für alkaptonurie (dsaku) e.v. " was founded in and became subsequently registered as a non-profit patient organization. first of all, the dsaku identified aku-patients, set up a homepage [ ] and designed flyers with information for patients, their families, medical professionals and healthcare services. second, it offered workshops on aku-related issues and enabled personal exchange. third, it raised awareness of aku, both nationally and internationally by information booths, presentations and posters at scientific congresses as well as rare disease days (rdd). fourth, in response to the needs of patients, it established collaborations and built up national networks for a better health care accordingly. thus, patients were encouraged to visit the centers for metabolic diseases at the charité (berlin), hannover medical school (mhh), university of düsseldorf and institute of human genetics at the university of würzburg to bundle knowledge and expertise. the dsaku is member of achse e.v., nakos, eurordis and metabern and registered in the databases se-atlas, zipse and orphanet. finally, the dsaku is nationally and internationally active in health politics regarding training in drug safety and evidence-based medicine. introduction: autoinflammatory diseases are rare conditions characterized by recurrent episodes of inflammation with fever associated to elevation of acute phase reactants and symptoms affecting mainly the mucocutaneous, musculoskeletal or gastrointestinal system. these diseases affect the quality of life of patients and their families. objectives: aim of this project is to develop a tool able to ameliorate patients' management of the disease and to enhance patientphysician communication. to develop a tool based on real-life needs, we involved patients and caregivers since the initial phase of the project. a first workshop designed to capture their needs was organized. innovative co-design activities were performed through "legoserious-play ™ " (lsp) methodology [ ] [ ] [ ] . during a first phase of "divergence" patients (from teen-agers to adults) affected by different aids (fmf, trap, caps, mkd) and physicians where involved in the lsp activities. participants were asked to describe, through lego and metaphors: • the disease • themselves in comparison with the disease • solutions and supports which could help them in managing the disease after each step the participants presented their models, and everyone was engaged in the discussion. the ideas collected during the three phases allowed to make a list of functionalities identified as necessary for the app to be developed. due to the actual sars-cov- sanitary emergency the second phase of the project, aimed at presenting the participants the results of the first meeting and proceed with the app finalization was performed through web-based meeting and surveys in which the patients and caregivers actively participated. results: in the first phase patients and caregivers participated actively expressing various needs, that we subsequently summarized in main areas (table ) . participants were then further involved and their opinion taken into consideration for the user experience and interface definition for the development of the mobile app including the required functionalities (after a further activity of prioritization). introduction: gaps in communication and education are becoming one of the biggest key pain points for patients that are suffering rare diseases. due to the limited resources and the misleading information on the internet we wanted to test the poc systems to deliver more efficiently the information to our patients and their relatives. userfriendly information at the point of care should be well structured, rapidly accessible, and comprehensive. method: we implemented a specific poc channel using several touchpoints to deliver the right content at the right time. we created and selected the video content that will be most helpful to our patients. later on, we analyzed the patient journey and we decided to use a mobile app where the patients could search for information when they are at their home. at the medical practice, we use the waiting room and exam room as learning areas through monitors and tablets. moreover, healthcare professionals are prescribing content to their patients that they reviewed when they are home. results: thanks to the use of the poc channel and technologies related we were able to reduce the time needed to perform an explanation by %. furthermore, our healthcare professionals reported that their conversations with the patients improved % and patient satisfaction increased by %. conclusion: poc channel created a positive impact on our patient experience allowing us to be more efficient delivering the information to our patients and their relatives. [ , ] , realworld safety and efficacy data are limited -particularly for patients who receive > treatment. we report initial data from the restore registry, including cohort clinical characteristics, treatments received, and outcomes. materials and methods: restore is a prospective, multicenter, treatment-agnostic registry of sma patients. the primary objectives include assessment of contemporary sma treatments; secondary objectives include assessment of healthcare resource utilization, caregiver burden, and changes in patient functional independence over time. planned follow-up is years from enrollment. as of january , data were available for patients, all from de novo clinical sites in the united states; information on treatment regimens was available for patients (table ) . disease-modifying treatments were administered sequentially or in combination. % of treated patients showed symptoms at sma diagnosis, with the most common being hypotonia and limb weakness ( table ) . Ågrenska, a swedish national centre for rare diseases, has for thirty years arranged courses for families of children with rare diagnoses and has experienced that the conditions often have complex and varying consequences in the children ś everyday lives. knowledge of these consequences and of how to adapt the treatment, environment and activities to create the best possible conditions for participation and learning, is often lacking. many professionals also report lack of sources of knowledge. knowledge formation and dissemination are thus of outmost importance. in order to aid knowledge formation and dissemination Ågrenska has developed an observation instrument for children with rare diagnoses, identifying both abilities and difficulties on a group level. the instrument consists of quantitative and qualitative items and covers ten areas: social/communicative ability, emotions and behaviours, communication and language, ability to manage his/her disability and everyday life, activities of daily life, gross and fine motor skills, perception and worldview, prerequisites for learning and basic school abilities. observations are made during the children ś school and pre-school activities during the Ågrenska course. teachers and special educators, working with the children, are responsible observers. some school-related abilities are difficult to observe during the five-day stay. this information is instead collected through a telephone interview with the children ś home teacher. the instrument was content validated against a number of existing instruments. the items were considered relevant as they, with few exceptions, appear in well-known assessment tools. to test interrater reliability observations of six children were performed. each child was observed by two educators. interrater reliability was calculated for the quantitative items usually observed during the course. interrater reliability reached . %. background: sma is a neurodegenerative disease caused by survival motor neuron gene (smn ) deletion or mutation [ , ] . disease severity (sma type) correlates with smn copy number [ , ] . gene therapy with onasemnogene abeparvovec provides sustained, continuous production of smn protein, and is fda approved [ ] , with ongoing trials for sma type (sma ) and sma , and presymptomatic treatment for all sma types. with treatment options available, many states in the united states (us) are implementing newborn screening (nbs) to detect smn deletions and smn copies, providing early diagnosis and the option of pre-symptomatic treatment [ ] . we examine the economic consequences of implementing nbs for sma and pre-symptomatic treatment with onasemnogene abeparvovec gene therapy among newborns in the us. a decision-analytic model was built to assess the cost effectiveness of nbs in , hypothetical newborns from a us third-party payer perspective. the model included separate arms, each allowing for a different treatment strategy. model inputs for epidemiology, test characteristics, and screening and treatment costs were based on publicly available literature (table ) . inputs and assumptions of lifetime costs and utilities for sma types were obtained from the institute for clinical and economic review sma report [ ] ; other values were sourced from published literature. model outputs included total costs, quality-adjusted life years (qalys), and incremental cost-effectiveness ratios (icers). scenario and sensitivity analyses tested model robustness. park's programme, particularly across education and engagement and prioritisation and development of research. in addition to representation on governance structures, wales gene park (wgp) collaborates with patients and the public to involve them in rare disease and genetic research. wgp has co-produced a rare disease research gateway following consultation with patients and the public from its networks. the gateway hosts relevant studies in genetic and rare disease research on the wgp website. it promotes involvement opportunities in addition to signposting to studies that patients and other members of the public can participate in. it also links to training opportunities for ppi representatives. consultation with patients and the public regarding the usability, design and development of the gateway was undertaken. feedback has enhanced the user experience and it was launched in october . there are currently over studies featured, and the gateway is searchable according to condition or key word. impact will be monitored through online usage and website analytics. engagement with researchers through a professional network enables opportunities to be advertised from all areas of genetic and rare disease research and ensures that patient and public representatives are involved in the design and development of research from its inception. wgp were invited to present at the welsh health and care research wales conference in as the gateway was highlighted as an exemplar of good practice. specialist visit, medications) and non-medical resource use (lost productivity and homecare or caregiver's time). outcomes of interest for treatment options assessed the efficacy and safety of treatments for rett syndrome. results: the search on economic burden yielded articles; intervention type and costs were extracted from , representing studies. in the economic burden studies, enteral feeding and assisted walking increased the risk of respiratory-related hospital admissions, while length-of-stay was lower in younger patients. mean recovery-stay after scoliosis-correcting surgery was . days and . days in each of studies. care integration improved outcomes and reduced costs. the search on clinical trials yielded articles; efficacy and safety were extracted from , representing studies ( randomized controlled trials, single-arm; n = - ; follow-up - months). of these, focused on pharmacological symptom treatment; examined environmental enrichment effects; none targeted the underlying cause. the most common primary endpoints are stated in table . naltrexone, trofinetide, and mecasermin demonstrated clinical benefits versus placebo, but most treatments yielded no significant improvement ( table ) . the cml advocates network (cml an) is an active network specifically for leaders of chronic myeloid leukemia (cml) patient groups, connecting patient organisations in countries on all continents. it was set-up and is run by cml patients and carers. its aim is to facilitate and support best practice sharing among patient advocates across the world. the cml community advisory board (cml-cab) is a working group of the cml advocates network. since its inception the cml-cab has met on nineteen occasions with five sponsors. the cml-cab is comprised of two chairs and cab-members. cml-cab organisation, sustainability and follow-up is supported by a part-time cml-cab officer and the cml-an executive director. the principles of leaving no one behind are essential to the goals of world health organization (who) and united nations (un). in , an ambitious objective to ensure that billion more people will benefit from universal health coverage (uhc) until was entrenched in the who th general programme of work [ ] . all un member states have agreed to try to achieve universal health coverage by , as part of the sustainable development goals [ ] . however, it is essential, that rare disease (rd) patients are not left behind on our trip to uhc. in , un declared that rd are among the most vulnerable groups that are still on the fringes of uhc [ ] . the first step on a way to the full uhc cube [ ] for rd is an identification of root causes of health inequities. health determinants of rd fundamentally differ from those for common diseases. some of them are unavoidable: up to % of rd have a genetic basis (individual or genetic determinants). although socio-economic factors are highly important, in contrast to common diseases, they are a consequence rather than a cause of rd. meanwhile, one of the major root cause amenable to change are health system determinants: organization of services for rd requires unique solutions in our health systems that are mostly adapted for common diseases. political and legal determinants also play a key role: while rd is an explicit example of an area, loaded orphanet j rare dis , (suppl ): with needs for pan-european solutions, relative "weakness" of eu legal powers to regulate and have an impact on implementation of pan-european policies in health results in vast inequities among and inside member states and lack of engagement at a national level. health activism that includes strong advocacy and a loud voice of patient organizations has also been ascribed to health determinants and may have a crucial role in rd [ ] to improve the situation, we already have some powerful tools at hand including national plans for rd, european reference networks [ ] and european joint programme on rare diseases [ ] . however, to reach the full potential of these, multiple obstacles have to be removed and full implementation ensured. since march , there has been an explosion in digital health adoption as people look for remote ways to manage their health and wellbeing. national government covid- strategies, local authorities and consumers, have all turned to health apps, both as a potential means of slowing the spread of the virus, and a method of allowing people to self-manage their own health. in the first few weeks of the covid- pandemic, orcha worked with app developers to build a dedicated covid- app library full of evaluated apps. free to use for all, it included relevant, quality assured apps that had been through orcha's rigorous review process. to build such a tool in such a short space of time is testament to the speed of this market. more consumers have been using health and care apps. in just one week, orcha saw an increase of . % in app downloads from its app libraries, and a , % increase in app recommendations from health and care professionals. orcha can see from the data across its app libraries that the most popular search terms since the pandemic began have included: mental health, physiotherapy, fitness, anxiety, rehabilitation, diabetes, respiratory, and sleep. whereas 'covid' was initially the most searched term at the beginning of the outbreak, people have since searched for specific condition areas. this indicates a shift in focus to actively self-managing health and wellbeing, and a desire for knowledge about particular health areas. the recent increase in digital health adoption has highlighted that the challenge remains of helping consumers to understand which apps are potentially unsafe to use, and ensuring that consumers are armed with the full facts about the strengths and weaknesses of an app, before it is downloaded. while considerable progresses have been made in the last years in research on innovative medicinal products for adults, children have not benefited from progresses to the same extent as adults in terms of appropriate treatments and advanced tools. it is well known that the availability of drugs for paediatric use still represents a challenging issue, since research and development in this field is characterized by many that range from methodological, ethical and economic reasons, especially when neonates and rare diseases are involved. moreover, even when industry has the capacity to perform a paediatric drug development plan, there are many economic reasons limiting the commercial sponsors' interest (the paediatric population is a small population; paediatric diseases often concern rare disorders with unknown mechanism; it is very difficult to perform preclinical and clinical studies; ethical concerns are still relevant and additional regulatory requirements have to be considered). in this scenario, eptri can make the different in closing the gap between innovative technologies and paediatric drug development processes. it is a eu-funded project that arises from the need to find answers to the serious lack of medicines for children in eu and worldwide, and aimed to design the framework for a european paediatric translational research infrastructure dedicated to paediatric research. an high interest is tailored on rare diseases (rd) as they affect mainly children and genetic rd start early in the prenatal/childhood life with an high frequent use of medicines not specifically tested (off-label, unlicensed). eptri will work to accelerate the paediatric drug development processes from medicines discovery, biomarkers identification and preclinical research to developmental pharmacology, age tailored formulations and medical devices. this will allow is to facilitate the translation of the acquired new knowledge and scientific innovation into paediatric clinical studies phases and medical use. neonatal screening started in many countries around - after phenylketonuria turned out to be a treatable condition. if diagnosed early, a diet could help to avoid impaired brain development. public health programmes were developed to offer all newborn children the possibility to be tested. screening always has benefits and disadvantages, and only rarely pros outweigh cons at reasonable costs. the world health organization in published criteria to evaluate benefits and disadvantages, concerning amongst others ( ) important health problem ( ) treatment ( ) suitable test and ( ) appropriate use of resources. pku was mentioned as an example of an important health problem [ ] . neonatal screening is more than a test. information to parents, communication of results, ict infrastructure, follow-up of affected infants, reimbursement of test and treatment and governance all need adequate attention [ ] . around the number of diseases covered in european countries in neonatal screening programs was very diverse: from zero in albania to more than in austria, hungary, iceland, portugal and spain [ ] . many countries have seen an increase in the number of diseases covered because of new tests and treatments becoming available. health authorities were almost always involved in changes in the programmes, hta experts and parents organizations sometimes. half of the countries had laws on nbd, and half had a body overseeing nbs programs. less than half of the countries informed parents of the storage of dried blood spots [ ] . after the eu initiated "tender nbs" had provided advice to eu policy makers [ ] , little initiatives for harmonization were taken, because health is the mandate of member states. from the perspective of newborns this implies that early diagnosis and adequate treatment for nbs conditions may differ very much for children being born in one or another eu country. with more tests and more treatments becoming available, this makes it even more urgent to attune the perspectives of different eu stakeholders for the benefit of all newborns. background: as genome sequencing is rapidly moving from research to clinical practice, evidence is needed to understand the experience of patients with rare diseases and their families. in the presentation, we discuss families' experience of receiving, making sense of and living with genomic information. the presentation includes video-clips from two short films from families' narratives. specifically, families struggled with the lack of information on the course of the disease, the difficulties to access support and navigate health and social care services, and the challenges related to making sense of the implications of genomic information for other family members. despite these issues, families identified a wide range of benefits from taking part in genome sequencing, which were broader than the clinical utility of the diagnosis. the findings raise questions regarding how to talk about 'diagnosis' in a way that reflects families' experience, including their uncertainty but also their perceived benefits. they also have implications for the design and delivery of health services in the genomic era, pointing to the need to better support families after their search for a diagnosis. saluscoop [http://www.salus coop.org] is a non-profit data cooperative for health research that aims to make a greater amount and diversity of data available to a broader set of health researchers, and to help citizens to manage their data for the common good. data heals. health research is data-driven: the larger the universe, the greater the quantity, quality, and diversity of the data, the more potential the data has to cure. in our european context, it is clear: data belongs citizen. gdpr regulates ownership and our rights over data that include portability. data protection laws rightly consider that health data deserves the maximum protection. however, the only truth, we note every day: in practice citizen often cannot access their data or control its use. the future of our health depends significantly on the ability to combine, integrate and share personal health data from different sources. the only one who can integrate all your information (public, private, clinical, personal, habits, genetics) is the citizen himself. using data well, it is possible to obtain more and better health for all. we are a cooperative that works to facilitate the transformation process towards this goals doing: -dissemination, awareness, communication -studies, manifestos. -licenses to facilitate it -salus common good license - it is necessary to dissociate the provision of services, of the possession of the data. the accumulation and centralization of the data is not necessary. blockchain and the like allow the certification of transactions without the need for intermediaries. the need for the existence of new social institutions for the collective management of data for the common good is much clearer today: so that these citizens have the technological and legal tools effectively manage their data. so that health research can address the real problems of our societies. the abstract is being presented on behalf of a saluscoop management board group. the region of murcia, located on the southeast of spain, has . million inhabitants. in , approximately % of its population was identified with a rd, based on the regional rd information system, which showed a public health problem requiring an integral and coordinated approach. results: in , after years of participative work (interdepartmental government representatives, patients associations and professionals) the regional plan for rd integrated (holistic) care was approved, for a period of years ( - ) and a budget of millions euros; with the goal of improving health, education and social care through interdisciplinary coordination and placing patients and families in the center of the actions. the plan includes ten different strategic areas related to information, prevention and early detection, healthcare, therapeutic resources, social-health care, social services, education, training of professionals, research, monitoring and evaluation a regional rd coordination center, linked to the medical genetics unit in the tertiary reference hospital, is connected to the health areas, educational and social local services, through a case manager integrated in the multidisciplinary team. this was our building experience presented in the innovcare project, co-funded by the eu. to design a holistic care plan for rd we need to know the prevalence based on rd registries, available and needed resources and an interdisciplinary participative action approach with the appropriate government and financial support with periodic evaluation. case management has an important role. the recognition of clinical genetics as health specialty is also urgent in spain to provide equal access to rd patients and families all over the country. [ ] . these policies have served us well, but it is essential that the policies guiding us towards the future we wish to see are equipped to address the needs of the future rd population. the rare project [ ] is working towards precisely this goal, and has identified over a hundred future-facing trends likely to impact on the field. some of these trends concern demographic changes about which we can be reasonably certain: whilst overwhelmingly positive, changes such as ageing rd populations will bring new challenges in managing comorbidities. they will also create new opportunities as well as risks in areas such as reproductive choice; however, these choices incur major ethical, legal and social concerns, and it is unclear how many countries really have robust frameworks in place to cope with this. besides the fairly certain demographic changes, there are many topics -and many needs-for which the future is not clear. will there be easier access to expert multidisciplinary teams? what will be the role of technology in care delivery? these fundamental issues are here debated in interview format [ ] . adrenoleukodystrophy, or ald, is a complex x-linked genetic brain disorder which mainly affects males between the ages of four and -males who are previously perfectly healthy and 'normal' . ald damages the myelin in the brain and spinal cord, and those with cerebral symptoms become completely dependent on their loved ones or carers. this usually involves patients becoming wheelchair or bed bound, blind, unable to speak or communicate and tube fed. it is a difficult disorder to diagnose with behaviour problems usually the primary indicator. in males, cerebral ald is a terminal illness with most dying within one to years of symptoms developing. if diagnosed before symptoms become apparent, usually through identification of a family member, the condition can be successfully treated through bone marrow transplant. some adults (males and females) develop a related condition called adrenomyeloneuropathy, or amn. symptoms include difficulty walking, bladder and bowel incontinence and sexual dysfunction. tragically, around one third of males with amn go on to develop cerebral ald. initial behavioural symptoms often have an impact on the individual's professional and personal lives -their capacity to work, maintain relationships and family ties -over time, they can become isolated and socially unacceptable. commonly, those individuals without supportive family structures are missed or misdiagnosed. the presentation presents a personal case study detailing the impact of an ald diagnosis on the whole family, moving on to alex tlc's experience in applying to add ald to the uk's new born screening programme. the conclusion includes next steps following an initial negative response, and thoughts on the methods used to assess decisions on the prevention and treatment of rare disease. the rare foresight study gathers the input of a large group key opinion leaders through an iterative process to propose recommendations for a new policy framework for people living with rare diseases (rd) in europe. since the adoption of the council recommendation on european action in the field of rd in , the european union has fostered tremendous progress in improving the lives of people living with rd. rare will recommendations for the next ten years and beyond. the rare foresight study includes major stages (fig. ) . the european conference on rare diseases and orphan products (ecrd ) marked the occasion to present four proposed future scenarios (fig. the market-led approach first creates the technology innovation, then seeks out its market. deep understanding of needs as the starting point of the innovation process. with symptoms and being suspected of having a rare disease can be the longest in many steps to getting a diagnosis. this is something we have the power to change now by providing content tailored to medics, early in their careers that will equip them to #daretothinkrare. to prepare for delivery of gene therapies, companies typically focus on four key areas: patient identification & diagnostics; treatment centre qualification; manufacturing & supply and market access. timely diagnosis of patients is important as with progressive disorders, the earlier patients are treated, typically the better their long-term clinical outcomes will be. targeted tools and resources are used to educate clinical specialists on the early symptoms of the disease. improving access to the appropriate diagnostic tests is essential. if newborn screening is considered, validated assays and pilot studies are required. gene therapies have to be administered in qualified treatment centres. after regulatory approval, treatment centres are relatively few so patients may need to cross borders and work is required to expand the recognition of patient rights to be treated in another eu country (e.g. through the s mechanism). many companies partner with contract manufacturing organisations and are developing ways to preserve gene-corrected stem cells to enable their transportation from the manufacturing site to treatment centres. the final area is market access, whereby it is vital to evolve the way healthcare systems think about delivery, funding and value determination. manufacturers have the responsibility to generate health economic evidence. recent research [ ] in metachromatic leukodystrophy showed that caregivers (n = ) spend an average of hours a day caring for their child. % of parents were forced to miss work with % of this being unpaid leave. in addition, it is recommended to have the optionality of payment models that allow the sharing of risk between the healthcare system and manufacturer (e.g. annuity or outcomes-based payments). orchard has developed a holistic value framework as gene therapies are expected to benefit patients, families, communities, healthcare systems and society reference background: employment has always been one of the fundamental human rights. it is important for people with rare diseases, because it helps to stay connected to the community and to continue professional development. equal access to job employment can help to overcome the consequences of the condition and to gain financial independence. on the other hand unemployment can increase the social exclusion. in the last few years there is an improvement in the european policies about job employment. in spite of this, people with rare diseases still have to overcome discrimination in this field. as a proof of this statement is the recent online survey, conducted by eurordis. according to it, % of the respondents admitted they had to reduce their professional activities after they were diagnosed with rare condition. this means that more than half of the people with rare diseases in europe face employment challenges. the analysis of this survey was important input to the presentation of the epf youth group project -ways. results: this is the abbreviation of work and youth strategy and it is a two year project, disseminated among young patients with chronic conditions. the main purpose was to increase the awareness about positive and negative practices for young patients on the labour market and to develop recommendations to employers and decision makers. that is why epf youth group conducted an online survey and provided different deliverables like factsheet with recommendations to employers and video about young patients' rights on the work place. the results of both survey provided important insight about the challenges people with rare diseases face in job employment. it proved the fact that only if we work together as a community of patients, we will be able to provide better opportunities for national and international inclusion. paul rieger , eberhard scheuer centiva health ag, zug, switzerland correspondence: paul rieger -paul@centiva.health orphanet journal of rare diseases , (suppl ):s the lack of access to research participants is the number one reason why medical studies fail [ ] . real-world data is often difficult to get despite usd billion costs of patient data intermediation. therefore, a new model for patient access is necessary where patients get paid fairly for their data, retain control over their data, and drive citizencentered research. on the other hand, researchers and industry must be enabled to access patients directly without violating their privacy, while reducing time and costs of data access at the same time. current patient registries facilitate patient access and match patients with a centralized data flow while giving little to no incentives. whereas, a decentralized patient registry allows for direct and confidential matchmaking between patients and organizations looking for data through the use of blockchain technology. it lets the patient decide with whom they want to share their data. on such a platform, patients can receive incentives in the form of digital currency. currently, centiva health [ ] is used in the context of rare diseases and population health, i.e., outbreak monitoring. in the area of rare diseases centiva health cooperates with patient advocacy groups by enhancing existing registries with the ability to collect real-world data. the access to patient via a decentralized registry leads to aligned incentives, real-time access to data, improved disease visibility while preserving patient privacy. orphanet j rare dis , (suppl ): the united kingdom and in the czech republic, to co-design optimal methods/services for the communication of genomic results. methods and results: using a methodology called experience-based co-design (ebcd) , we supported families and health professionals to shared and discuss their experiences, identify priories for improvement and then work together to prototype and test out interventions to address these. the process involved observations of clinical appointments (), interviews with families () and health professionals and a series of workshops and remote consultations at both sites. results: five shared priorities for improvement were identified by participants at the two sites, and eight quality improvement interventions were prototyped/tested to address these ( table ) . discussion: the findings clearly indicate the need for improved follow-up care to support families in the short, medium term after the sharing of the results, including when a diagnosis is confirmed. different service models were prototyped, including follow up consultations with clinical geneticists and a dedicated role to facilitate co-ordinated care. the findings also demonstrate the need for continued workforce development on the psychosocial aspects of genomic and genetic communication, specifically on families' needs regarding genomic consent and the experience of guilt and (self-) blame. to use technology has been used in the home to provide objective seizure data prior to upcoming clinic appointments. the covid- pandemic has prompted an acceleration in telemedicine and epihunter has improved the effectiveness of virtual consultations bringing opportunities for both diagnostics and informed changes in treatment. epihunter is an example of technology repurposing to create a new normal for people with hidden disabilities such as those living with absence epilepsy. the rare disease patient community tried to get this well detailed plan to be transferred to regulation which usually means an adequate financial substitution of those expert services. the patients should benefit from a centralized expert treatment/care pathway. esophageal atresia (ea) is a rare congenital condition with an estimated prevalence of to in , live births. esophageal atresia patients require life-long attention. ernica has developed a 'patient journey' for ea patients, under the leadership of patient representatives from the international federation of ea support groups (eat). in germany, patients with congenital malformations which need surgery in early life are treated in hospitals with (very) low experience. how can we as patient representatives get the fruits of the erns into the national health system? we don't have public money. we have no official contract and no political support. keks e.v., the german ea support group together with other support groups (e.g. soma e.v.), and with surgical expert teams across germany, some of them members in erns, started to organize monthly virtual boards for those patients. a self-commitment on ethical and medical standards following the ern-criteria, and a collaborative attitude within the group, help us to get step by step the first ernica results to the bedside of ea patients. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. delays in completion and results reporting of clinical trials under the paediatric regulation in the european union: a cohort study new strategies for the conduct of clinical trials in pediatric pulmonary arterial hypertension: outcome of a multistakeholder meeting with held at the european medicines agency on monday decentralized rather than centralized pediatric surgery care in germany erdri.dor -european directory of registries natural history of alkaptonuria recent advances in management of alkaptonuria when you build in the world, you build in your mind white paper on lego serious play articulation of tacit and complex knowledge zolgensma (onasemnogene abeparvovec-xioi) childhood spinal muscular atrophy: controversies and challenges spinal muscular atrophy bannockburn, il indirect estimation of the prevalence of spinal muscular atrophy type i, ii, and iii in the united states pilot study of populationbased newborn screening for spinal muscular atrophy in new york state presymptomatic diagnosis of spinal muscular atrophy through newborn screening one year of newborn screening for sma -results of a german pilot project correlation between sma type and smn copy number revisited: an analysis of unrelated spanish patients and a compilation of reported cases available from: www.ibm.com/produ cts/micro medex -red-book available from: www.ibm.com/produ cts/micro medex -red-book references . united kingdom national health service international rett syndrome foundation presented at aacap's th annual meeting placebo-controlled crossover assessment of mecasermin for the treatment of rett syndrome cerebrolysin therapy in rett syndrome: clinical and eeg mapping study effects of acetyl-l-carnitine on cardiac dysautonomia in rett syndrome: prevention of sudden death? rett syndrome: controlled study of an oral opiate antagonist, naltrexone pharmacologic treatment of rett syndrome with glatiramer acetate safety, pharmacokinetics, and preliminary assessment of efficacy of mecasermin (recombinant human igf- ) for the treatment of rett syndrome effects of ω- pufas supplementation on myocardial function and oxidative stress markers in typical rett syndrome thirteenth general programme of work - . promote health -keep the world safe -serve the vulnerable principles and practice of screening for disease newborn screening programmes in europe; arguments and efforts regarding harmonization. part -from screening laboratory results to treatment, follow-up and quality assurance newborn screening programmes in europe; arguments and efforts regarding harmonization. part -from blood spot to screening result a framework to start the debate on neonatal screening policies in the eu: an expert opinion document communication from the commission to the european parliament, the council, the european economic and social committee and the committee of the regions on rare diseases: europe's challenges on an action in the field of rare diseases on the application of patients' rights in cross-border healthcare available from: https :// drive .googl e.com/file/d/ sfe xp deisc ogrbw swht uznx erj/ view?usp=shari ng . which scenarios are most preferred by the rd community? . which scenarios are most likely to happen? . how do we achieve the scenarios we prefer and avoid those we don factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review s background: to help inform cross-national development of genomic care pathways, we worked with families of patients with rare diseases and health professionals from two european genetic services bringing user experience to health care improvement: the concepts, methods and practices of experience-based design department of medical informatics correspondence: info-rdsgofair@go-fair.org (marco roos -m.roos@ lumc.nl, gülçin gümüş -gulcin.gumus@eurordis.org) in practice, it can take months of searching data, understanding the sources, mapping to consistent standards, and negotiating how one might use the data. many assume that for sharing and analysis, data need to be moved between sources. this can lead to sharing only minimal, non-sensitive data: a fraction of global rare disease data. alternatively, data elements and local access conditions can be described by globally agreed, computer understandable standards conform fair principles. this enables analysis at each source, while sharing only the analysis results. fair prepares data for rapid discovery, access, and analysis, also when data remain at source. projects such as the european joint programme for rare diseases work on the technical infrastructure to support this. adopting fair principles requires culture change. fair advocates working on rare diseases have organised the 'rare diseases global open fair implementation network rds go fair prioritizes patient representatives for their capacity to reshape current practices, welcoming them to organise their own network within rds go fair to foster fair for patient priorities (registration for follow-up meetings is possible via eucerd recommendations on quality criteria for centres of expertise for rare diseases in member states joint action rd-action (european union's health programme european commission website pdf s patient's view on disruptive innovations in clinical research elizabeth vroom we would like to thank the j-rare patient organization groups and the asrid research ethics committee. consent to publish: informed consent to publish has been obtained from patients. we thank all the families who took part in the interviews, the staff of the health services and charities who collaborated to advertise the study to eligible participants and the members of the family advisory groups who reviewed the interview schedule and provided invaluable feedback on the preliminary findings. the work has been presented on behalf of the study "improving the communication of genomic diagnosis results using experience based co-design (ebcd)", which is part of the solve rd project. the solve-rd project has received funding from the european union's horizon research and innovation programme under grant agreement no . we thank all the families who took part in the interviews, the staff of the health services and charities who collaborated to advertise the study to eligible participants and the members of the family advisory groups who reviewed the interview schedule and provided invaluable feedback on the preliminary findings. the work has been presented on behalf of the study "improving the communication of genomic diagnosis results using experience based co-design (ebcd)", which is part of the solve rd project. the solve-rd project has received funding from the european union's horizon research and innovation programme under grant agreement no . acknowledgements: we would like to thank all seed group members of the rare diseases global open fair implementation network, the go fair office, eurordis, the european union's horizon research and innovation program under the ejp rd cofund-ejp n° , the rd-connect community, the lumc biosemantics research group, simone louisse (guardheart epag), and the many patients and patient representatives that inspire us. recent advances in next-generation phenotyping (ngp) for syndromology, such as deepgestalt, have learned phenotype representations of multiple disorders by training on thousands of patient photos. however, many mendelian syndromes are still not represented by existing ngp tools, as only a handful of patients were diagnosed. moreover, the current architecture for syndrome classification, e.g., in deepgestalt, is trained "end-to-end", that is photos of molecularly confirmed cases are presented to the network and a node in the output layer, that will correspond to this syndrome, is maximized in its activity during training. this approach will not be applicable to any syndrome that was not part of the training set, and it cannot explain similarities among patients. therefore, we propose "gestaltmatch" as an extension of deepgestalt that utilizes the similarities among patients to identify syndromic patients by their facial gestalt to extend the coverage of ngp tools. methods: we compiled a dataset consisting of , patients with , different rare disorders. for each individual, a frontal photo and the molecularly confirmed diagnosis were available. we considered the deep convolutional neural network (dcnn) in deepgestalt as a composition of a feature encoder and a classifier. the last fully-connected layer in the feature encoder was taken as facial phenotypic descriptor (fpd). we trained the dcnn on the patients' frontal photos to optimize the fpd and to define a clinical face phenotype space (cfps). the similarities among each patient were quantified by cosine distance in cfps. results: patients with similar syndromic phenotypes were located in close proximity in the cfps. ranking syndromes by distance in cfps, we first showed that gestaltmatch provides a better generalization of syndromic features than a face recognition model that was only trained on healthy individuals. moreover, we achieved % top- accuracy in identifying rare mendelian diseases that were excluded from the training set. we further proved that the distinguishability of syndromic disorders does not correlate with its prevalence. conclusions: gestaltmatch enables matching novel phenotypes and thus complements related molecular approaches.an audience of over delegates voted on the rare scenarios and discussions throughout the sessions of ecrd indicated the following opinions:-if we continue as we are we will find ourselves in the "fast over fair" scenario which forecasts high collective responsibility but an emphasis on market-led innovation -the majority of the audience preferred a future scenario with continued high collective accountability but more of an emphasis on needs-led innovation, "investments for social justice" -a significant portion of the audience agreed that a balance must remain with the market led attractiveness of the "technology along will save you" scenario -a scenario where "it's up to you to get what you need" was least preferred by all the diagnostic pathway in rare disease has a number of bottlenecks that can result in the pathway becoming an odyssey. while some barriers are being removed through remarkable innovation, there is one story of diagnostic delay that is echoed by rare disease patients across the globe and across thousands of different rare diseases: doctors failed to suspect something rare. however we cannot expect doctors to suspect rare diseases when they haven't been trained to or, in some cases, have been trained to do the exact opposite with the mantra "common things are common". without appropriate training 'rare' can be mistaken for 'irrelevant' when in reality million european citizens live with a rare disease [ ] . medics rarediseases is driving an attitude change towards rare diseases in the medical profession. this begins with explaining that rare diseases are collectively common and all clinicians should expect to manage people with diagnosed and undiagnosed rare disease regularly during their careers. this attitude change is called #daretothinkrare. secondly m rd is suggesting a new approach to educating about rare disease for trainers and training institutes. this approach tackles rare disease as a collective and focuses on patient needs rather than details of individual diseases. this not only solves the impossible challenge of covering over rare diseases during medical training but also provides some equity between different diseases. lastly, m rd promotes the use of rare disease specific resources that will support both doctors and their patients. this includes the invaluable input from patient advocacy groups. the step between presenting quality assurance of rare disease (rd) centers of excellence (coe) through designation, accreditation, monitoring and constant improvement provides a means to ensure high quality, centralization of resources and expertise, and cost-efficiency. eucerd recommendations for quality criteria of coe, issued in , are still highly relevant [ ] . in the state of art resource, almost all european union (eu) member states (ms) claim, that their coes conform to eucerd recommendations [ ] . however, national quality assurance processes differ significantly: some ms apply robust procedures, while in other ms, many of them -but not exclusively -are eu- ms, processes of quality assurance are less developed. under the subsidiarity principle embedded into european treaties, the eu plays a limited role in many areas of healthcare, and coes quality assurance processes are a choice and responsibility of ms.with the establishment of erns, another layer of quality assurance has been developed by the european commission and the ms [ ] . this new quality assurance framework may be in line, or not, with national accreditation systems and involves i) assessment of coes when they apply for full membership of erns and ii) continuous monitoring afterwards [ ] . in every ern, members have to be "equal partners in the game" and share the same goals, rights and obligations. while the ern logo should eventually be a quality mark of the highest standards, strong links of ern members to national systems, including many more and less specialized healthcare providers, are essential to ensure proper care pathways for rd patients. importantly, erns themselves and patients/non-governmental organizations provide us with additional means of "informal quality assurance". many erns are implementing their own monitoring processes through the creation of registries to collect health outcomes that allow peer-benchmarking. meanwhile, patients provide their strong voice through european patient advocacy groups (epags) and help to signpost "the best" coes through information sharing. in both these processes, the power of open, transparent information on performance may finally lead to improved transparency and accountability at a national level and, presumably, may have an impact on the composition of erns in the future. in order to improve clinical research, patient preferences and outcome measures relevant to patients should become the core of drug development and be implemented from the earliest stage of drug development. from 'bedside to bench' instead of from 'bench to bedside' . at all levels the reuse of data could and should be enhanced. patient derived or provided data are not owned by those who collected them, and their reuse should be primarily controlled by the donors of these data. researchers and health professionals are custodians (gdpr). to enable the optimal reuse of real world data, the data needs to be findable, accessible, interoperable and reusable (fair) by medical professionals, patients and in particular also by machines. for this reason the world duchenne organization published a duchenne fair data declaration [ ] . reuse of placebo data and use of natural history data could speed up research especially in the field of rare diseases at this moment, in line with gdpr, patients are in a good position to decide about the reuse of their own data and should not only have access to these data but preferable also be in charge of their own data. background: drug repurposing for rare disease has brought more costeffective and timely treatment options to patients compared to traditional orphan drug development, however this approach focuses purely on medical interventions and requires extensive clinical trials prior to approval. in the case of refractory epilepsy, practical solutions are also required to better manage daily life. here we present an example of technology repurposing as a practical aid to managing absence epilepsy. methodology: existing research tells us that seizure control is not the only consideration of quality of life in children with epilepsy and that mental health and caregiver/peer support are of utmost importance. we explored the needs of stakeholders and determined that there was a delicate balance between the individual (and those that care for them) and those that have the power to change their lives. results: across all stakeholders there was a shared common need to obtain objective data on absence monitoring to relieve the burden on families/carers to retain manual seizure diaries whilst providing accurate and timely data to medical teams, researchers and social care. epihunter is an absence seizure tracking software using repurposed technology: a headset from wellness/leisure to collect electroencephalographic (eeg) data and an ai algorithm to detect and record absence seizures on a mobile phone application in real-time. both eeg and video recording of the seizure are automatically captured. this low cost, easy key: cord- - zkbi z authors: ali, sana title: combatting against covid- & misinformation: a systematic review date: - - journal: hu arenas doi: . /s - - - sha: doc_id: cord_uid: zkbi z accompanied by false information, mass media content is hindering efforts to cope with the current outbreak. although the world health organization and other concerned bodies are notified regarding misinformation, myths and rumors are highly prevalent. this paper aims to highlight the misinformation and its potential impacts during the covid- by using the systematic review approach. the researcher randomly selected n = research articles published from to , witnessing the misinformation as a major concern during previous endemics and the current covid- pandemic. myths and rumors through traditional and new media platforms cause xenophobia, lgbt rights violations, and psychological disorders among the masses. despite the efforts made by the world health organization, much more is required to nullify the impacts of misinformation and covid- . therefore, the researcher recommended improved global healthcare policies and strategies to counteract against misinformation to mitigate the impacts of covid- . corona virus is a threatening respiratory disease that has been described more than fifty years ago, causing various diseases in animals, including gastroenteritis, damaging the central nervous system, and respiratory system (weiss and navas-martin ) . however, it is only linked with damaging the respiratory system leading to death (van der hoek ) . one of the most prominent outbreaks of severe acute respiratory syndrome (sars) can be traced back in with an ecological origin in bats and affirmed that the virus does not have any laboratory origins (who ), while middle east respiratory syndrome (mers-cov), also raised as one of the most acute respiratory diseases (world health organization ) . many studies also found that these viruses affect the animals and transmit to humans, for instance, sars-cov- first infected the cats and then transmitted to humans. likewise, middle east respiratory syndrome (mers-cov) was found in camels and transmitted to humans (who ) . the available genetic sequence data showed a close between viruses found in camels also found in humans (world health organization ) . therefore, on december st, , the world health organization was formally notified regarding a cluster of pneumonia cases in wuhan, china. ten days later, the world health organization again informed about confirmed cases in the neighboring countries, including japan, thailand, and korea. twelve people were in critical condition, were hospitalized due to severe illness, and six were died (chaplin ) . during january , a total of , cases of corona virus had been reported worldwide. besides, several travel-related and isolation cases were reported from the united states, vietnam, austria, and korea. as of january th, more than deaths were also confirmed in china (cortellis ). as a result, the world health organization declared it a global health emergency and introduced several healthcare protocols to mitigate its potential impacts (baumeister ) . similarly, the covid- outbreak also raised many social and economic challenges worldwide (j. wang and wang ) . also, the vaccine is yet not developed, which further worsens the situation (cortellis ) whereas, unicef ( ) considers taking all the preventive measures as an only immunization to mitigate the virus transmission. for this purpose, media platforms realized the need to educate the people to bring the positive attitudinal changes as mass media are the essential resources to supply credible information (zhong et al. ) however, combating rumors and myths regarding corona virus is a major challenge for media today. for instance, fox news faced criticism for spreading particular misinformation and false beliefs regarding the pandemic as hannity and tucker carlson tonight were the two most-watched shows framing the pandemic as a part of president trump's political agenda (bursztyn et al. ) . in this context, there are four main areas where people seek information but are highly accompanied by rumors and false information (geerdink ) (i) transmission and the symptoms of the disease, (ii) cure and prophylactics, (iii) origins and causes (iv) impacts and effectiveness of policies designed by healthcare organizations (culp ) . figure below illustrates the primary sources of infodemic that can make pandemic worse and even more challenging. in february , the world health organization affirmed the covid- pandemic accompanied by misinformation (who ). according to colomina ( ) , one of the significant differences between covid- and previous outbreaks is that now fears are immediately viralized to provoke confusion and uncertainty. in this regard, social media platforms are mainly disseminating false information along-with traditional media resources. although increased access to digital media platforms facilitated exponential access to information during the current pandemic, several fabricated stories are shared without quality checking and background (pan american healthcare organization, ). the rapid spread of the corona virus during the past couple of months led to several conspiracy theories prevailing through online resources with a common theme that virus is artificially created according to a particular agenda. this information was disseminated initially from unknown social media accounts and engaged more than million people worldwide (mian and khan, ) . as the world health organization warned about misinformation due to an independent media usage, today, people are finding it hard to search for a reliable source of information, hindering the response efforts causing severe damage to the struggle for mitigating the outbreak (article ). as noted by bontcheva ( ) , both misinformation creates confusion regarding scientific contributions to counteract against covid- . direct transmission adversely affects every individual and society on this planet, causing more harm and destruction during the current outbreak. thus, this study supports the existing literature concerning misinformation and its potential impacts, especially during the current covid- pandemic. review studies are unique as they authenticate the previous studies and provide more ideas for future research on the same topic (young ) . therefore, in the third section, the researcher discussed relevant studies witnessing information and their potential impacts. in the fourth section, the researcher discussed the steps are taken up by the world health organization, united nations, and other concerned bodies to mitigate the misinformation and further made the conclusions. finally, in the last section, study, contributions and limitations are mentioned along-with the relevant recommendations. recent trends in mass media ecosystems raise critical concerns regarding misinformation and audience susceptibility to contain it. as compared to past, misinformation is more capable of rapid dissemination due to audience-centered social media platforms. along with traditional media channels, online platforms are a subtle source of misinformation that further worsen the situation (lazer et al. ) . however, misinformation is not the result of sub-standard media practices, instead, it results from poor media practices. nevertheless, poor practices misinformation leak into real news media practices, and for this reason, today, media resources are confronting the risk of "being drowned by cacophony" (ireton and posetti ) . in this regard, wojczewski et al. ( ) examined the portrayals of local healthcare crises and healthcare services in ugandan newspapers. the researchers utilized the qualitative approach and selected two popular newspapers in uganda. results revealed that although newspapers published several news reports during the designated period, they attributed the healthcare issues to weak government, corruption, and lack of attention towards the healthcare management system. therefore, the researchers concluded that the reports were narrowly targeting political entities and less concerned about the health wellbeing. gollust et al. ( ) further addressed misinformation in televisions as a result of agenda-setting and causing severe threats to local healthcare systems and undermining ongoing health-wellbeing efforts. the researchers cited the example of cancer-based news reports on the us news media channels and highlighted how most of the news and programs were based on cancer, neglecting other diseases, including hiv. this excessive exposure to the single health issue also contained rumors, myths, and false information about cancer, diagnosis, and treatment in the past. also affirmed by ophir ( ) , as he investigated the american newspapers' coverage of three famous endemics in the past, including zika, h n , and ebola. the researchers used content analysis and interview techniques and selected a sample of n = , articles from the local newspapers. findings showed that the relevant news articles mainly contained framed information, capable of spreading misinformation. after exposure to selected news articles, respondents also revealed an increased uncertainty towards the crisis and emergency risk communication (cerc) and the centers for disease control and prevention (cdc). however, critics especially describe the current period as an "era of false information" spread through digital media resources. all the media types facilitate this dissemination but new media platforms are comparatively more productive resources (y. wang et al. ) . the researchers also analyzed the relevant literature witnessing false information on digital media platforms. the researchers selected a sample of n = research articles and found that misinformation could be easily found during the healthcare crisis, especially ebola and zika viruses. similarly, misinformation was also reported concerning cancer, hiv, and others. similarly, swire-thompson and lazer ( ) scrutinized the correlation between misinformation and online available healthcare mobile applications and social media posts. according to the researchers, during past online health misinformation, for instance, measles, mumps, and rubella vaccination cause autism among children. the systematic review of the literature also validated that digital platforms are the richest sources of misinformation. likewise, misinformation is only characterized as an organized effort to avail power, personal interest, and control over the belief system. another study to examine the misinformation through social media was conducted by ghenai and mejova ( ) . the researchers selected a sample of n = , to obtain discussions about cancer, its diagnosis, and treatment. results indicated that the rumors about cancer treatment were the main topic of discussion, containing many retweets. bold claims about different drinks and foods i.e., ginger, banana, honey, and others, were the most circulated myths about the treatment. therefore, with the value of . *** (p ≤ . ), the researchers found a strong significant correlation between digital media and misinformation. the right to freedom of information and expression is absolute; sometimes, it is accompanied by propaganda and misinformation. an explicit example can be seen during the covid- pandemic, where different media platforms are found disseminating the myths and false information (article ). for this purpose, hall jamieson and albarracín ( ) examined the united states electronic news media coverage regarding misinformation. probability-based surveys during the beginning of covid- revealed that news reports on nbc news broadcasted accurate information and reinforced awareness behavior; however, fox news was mainly found disseminating conspiracy regarding covid- . the misinformation mainly involved rumors i.e., cdc is exaggerating the pandemic to harm donald trump's reputation. however, according to r, d, waran ( ), besides the disease outbreak, misinformation through different media resources is also a major challenge. for many, social media platforms are comparatively more powerful to spread information. to further validate this, the researchers also investigated the extent to which social networking sites are spreading misinformation using a qualitative study approach. the researchers selected purposive sampling techniques, open-ended interviews, and systematic study methods for data gathering purposes. results revealed that respondents expressed social networking sites as containing both information and misinformation; however, due to lack of knowledge containing reliable resources, people mostly expose to unauthentic information. misinformation not only leads them to gather misinformation but also share with others through online platforms. similarly, brennen et al. ( ) examined the sources of misinformation regarding covid- in great britain. the researchers randomly selected social media platforms and traditional media resources. findings revealed that out of three prominent (youtube, facebook, twitter) social media platforms, twitter contains comparatively highest ( %) number of misinformation. likewise, television, compared to print media, spread more misinformation, reinforcing public engagement to disseminate false information through interpersonal communication. another study to authenticate this phenomenon was conducted by (kouzy et al. ) . the researches randomly selected n = most trending hashtags on twitter and analyzed n = tweets from individual users. results showed that total n = tweets contained myths and % of information was also from unverified accounts, out of which % of accounts misinformation and decontextualized details. also investigated the role of online platforms, particularly twitter, to spread misinformation during the covid- . the researchers used the content analysis approach and selected a random sample of n = tweets. findings showed that a majority of tweets contained false information ( . %), but only . % misinformation was retweeted. according to the researchers, these . % tweets can still be very detrimental for the efforts concerning mitigation of covid- . during the current pandemic, online platforms are easily accessible, easy to use, and are preferred mainly due to substantial public involvement. accompanied by a lack of objective information, these platforms are a significant source of misinformation and unauthentic news (accessnow.org ). in this regard, li et al. ( ) scrutinize the role of youtube videos for disseminating the misinformation during covid- . the researchers randomly selected a sample of n = online videos and used the content analysis technique. results revealed that the majority ( %) of online videos mostly contained misinformation i.e., myths, vaccination discovery, and decontextualization. therefore, more than one-quarter of the most-viewed youtube videos contained misinformation, and the sources were popular news platforms. aspi ( ) also investigated the chinese state media and diplomatic twitter accounts and types of information spread through them. the researchers selected a random sample of tweets during march and found that much of the misinformation was firmly related to conspiracy theories concerning disease origins and the vaccination. moreover, n = of the twitter accounts were also from unauthentic resources containing retweets of trolls and myths. therefore, the number of misinformation and retweets were comparatively higher than accurate information and their spread by ordinary users. likewise, sharma et al. ( ) designed a track board to identify misinformation through different twitter accounts. the researchers gathered streaming data from march st, to may, th , and found a massive number of tweets containing discussions on covid- . results gathered from . million tweens revealed that the majority of tweets were themed on four primary topics: political bias, reliability, conspiracy, and clickbait. although the number of misinformation varied from country to country, the retweeting behavior was a primary mechanism of spreading misinformation. furthermore, laato et al. ( ) examined the extent to which online platforms are spreading misinformation during the covid- pandemic, and what are the potential reasons behind it? the researcher used a structured survey questionnaire and gathered responses from n = respondents in bangladesh. respondents revealed that they receive and share the information without any authentication and filtration. although they know that information comes from unknown resources, they still share it as online information sharing is a typical behavior today. the researchers concluded that this information sharing behavior is the leading cause of misinformation that may bring adverse outcomes. pennycook et al. ( ) also analyzed the online information-sharing behavior during covid- among americans. the researchers selected a sample of n = participants and gathered data by using close-ended survey questionnaires. the results indicated that the majority of the respondents prefer to share information without validation. for them, information sharing is essential to aware the masses. however, affirmation is not considerable. on the other hand, a few respondents with critical thinking revealed that they are considerate about information sharing and do not pass on any posts without authentication. xenophobia mass media provide individual narratives to a different phenomenon, including biomedical research. narrative communication deeply affects public perception, especially during the healthcare crises (caulfield et al. ) . riddled with decontextualization, pseudoscience, fake news and rumors, many consider covid- as a result of intentionality and the personal interests as the falsity is not an only problem, but also rumors are spread by highly influential individuals even accompanied by hate speech and racism as well (geerdink ; colomina ) . these rumors are strongly associated with the stigmatization of immigrants and discrimination against them. the covid- pandemic's politicization is adopted by several anti-immigrant and hate groups spreading various conspiracy theories claiming the spread of corona virus as a result of migration (iiom ). with thousands of new cases every day, corona virus causes unprecedented disruption in human societies. due to the broader spread of misinformation, our understanding of covid- is still evolving. undermining all the efforts made by health experts worldwide, this misinformation is characterized by adverse outcomes, including intolerance, racism, inequality, and unhealthy behaviors (limaye et al. ) . in this regard, rzymski and nowicki ( ) examined whether and to what extent asian medical students face discrimination in poland. the researcher conducted a cross-sectional study and randomly selected a sample of n = students from poland having asian origin. participants revealed that they are facing discrimination and isolation due to their origin. they also have to spend their time in isolation, which is adversely affecting their career development. similarly, jeung et al. ( ) analyzed the frequency of xenophobic news reports in american news media and their impacts on real-life situations from february to march . the researchers conducted both content analysis and review of relevant literature (n = articles) witnessing xenophobia. results indicated that the number of discriminatory news reports increased from n = per day to n = during march. an average of n = cases is reported regarding xenophobia, which means that news reports are highly influential on real-life behavior, increasing the xenophobia among the public. according to article ( ), misinformation causes anti-foreigner and anti-chinese sentiments in several parts of the globe. this misinformation can be primarily seen on the social media platform. however, traditional media also push highly discriminatory content and business communities posting online platforms signed petitions to ban the chinese customers. many conspiracy theories also attributed corona virus to jews, muslims, bahai's, and other communities, resulting in discrimination and hate crimes (united nations ). also, the xenophobia against chinese is prevalent among european nations. during the current health crisis, the situation hinders the dialogue between beijing and europe, amplifying significant disagreements between these two (aies ). also affirmed by reny and barreto ( ) , as they investigated the americans' perceptions towards asians, mainly chinese during covid- . the researcher selected a sample of n = , american respondents and used close-ended structured questionnaires. results showed that xenophobia and anti-asian attitudes were strongly associated with the covid- misinformation. initially, the anti-asian attitude was low but highly increased due to a variety of myths, rumors, and decontextualization of news reports. similarly, the world health organization also declared lesbian, gay, bisexual, trans, and intersex (lgbti) communities more vulnerable during the current pandemic. due to the stigmatization and discrimination against lgbti, several individuals face difficulty accessing healthcare services. they face online hate speech and bullying at home due to the lockdown situation, hindering their fundamental human rights (unhr ). according to gmhc ( ), even old age lgbt individuals living in congregate facilities may also face deprivation of medical; services. healthcare professionals can refuse their treatment and consider them as potential careers covid- (unconscious bias). also, among many public healthcare systems, the lgbt community lacks sex and marital status, making them ineligible for the provision of healthcare services (lokot and avakyan ). jayaseelan et al. ( ) investigated the impacts of social media based misinformation on audience behavior during covid . the researcher used a qualitative approach and selected a sample of n = undergraduate university-level students. findings showed that students consider social media as a source of information, and most of them like to share the information with others without authentication. however, misinformation covers a significant part of these posts affecting their healthcare behavior and raises uncertainty regarding the local healthcare system. furthermore, false information about covid- is not a new phenomenon as many academics, researchers, journalists, and policymakers approached world health organization and emphasized that this would cause serious risk to public mental and physical health (brennen et al. ) . people living in isolation, risk of infectious disease, and quarantine rely mainly on media for information that is more vulnerable to psychological disorders. curiosity and fear lead them to seek information through different media platforms. in this regard, misinformation plays a vital role in undermining one's mental health by inducing fear, anxiety, and stress. misinformation also caused food insecurities among the masses with low socio-economic status, intensively exacerbated demand-supply gaps, and largely disrupted supply chain worldwide (tasnim et al. ) . in this regard, ravi philip rajkumar ( ) investigated the impacts of covid- and myths on individuals' mental health. the researcher conducted a thematic review study and found that anxiety, stress, and depression are the most prominent psychological problems during covid- . also, these disorders were strongly associated with disturbed sleep among the public. therefore, the researcher suggested avoiding syndromal mental health concerns raised by covid- should be eliminated by counteracting against the misinformation and its potential resources. also affirmed by tasnim et al. ( ) as they highlighted the misinformation as an increased challenge during global healthcare emergency. misinformation mainly contains hoaxes, decontextualization, and myths about the origin and etiology of the disease-causing mental disorders among the public. the spread of misinformation is also undermining healthy behaviors and efforts to spread healthcare awareness among the masses. figure below provides a graphical representation of misinformation sources, types, and potential impacts. literature review studies tend to highlight existing concerns with valid argumentation. it is more like finding pieces of a puzzle which further highlights the importance of the relevant phenomenon (library ). in this regard, the current study also utilized a systematic review approach to retrieve suitable research investigations (habes et al. ). the researchers systematically gathered peer-reviewed published research articles from to june . these articles contained diverse study methods (survey, content analysis, interview, literature review & others) and paradigm models (quantitative, qualitative) to identify the widespread misinformation and its impacts. moreover, the researcher mainly gathered articles from the top journals of media, social sciences, psychology, medicine, health, humanities, and human rights from the isi web of knowledge journal citation reports according to the value of their impact factor, scopus and web of science indexation. the selected journals involved: international journal of biological science, educational research and reviews, social science and medicine, health communication, annual review of public health, and others. however, many of the citations also belong to situation reports, perspectives, policy briefs public by the world health organisation, international labour organization (ilo), and others. therefore, a total of n = of the published research content was reported according to the designated criteria. the data of each criterion is given below with the relevant tables and graph: figure above shows the percentage of relevant articles by year. however, it is observable that out of n = research articles, the majority of misinformation related papers published in during the peak of the covid- pandemic. besides the healthcare challenges, misinformation also created chaos creating even more severe challenges (nguyen and nguyen ). table above shows the study design of the cited articles. the studies involve experimental design, case study, review approach, and others. however, n = or % cited articles involve policy briefs and situational reports issued by the world health organization, unesco, pan american health organization (paho), unicef, and international labour organization (ilo). similarly, according to the paradigm models, it is observable that a majority n = or % of studies were quantitative, n = or % were qualitative, and % of articles were research essays, commentaries, perspectives, policy briefs and, situational reports. table above shows the different types of data collection methods in the selected literature. the majority of studies (n = or %) utilized the media content analysis technique to investigate the potential types and sources of information. however, % of the articles contained policy briefs, situational reports, research perspectives, and others. likewise, the selected literature also contained an analysis of diverse types of media types. in this regard, a majority (n = , %) of studies focused on print media and social media to investigate the widespread misinformation. according to orso et al. ( ) , due to an increased number of information sources, people widely depend on mass media. during the pandemic, this dependence is creating several problems due to the rampant misinformation. mainstream media platforms mostly contain fake news and rumors. the long-standing issue of misinformation regarding different sociopolitical issues is under constant discussion. however, misinformation during the current pandemic raised many concerns regarding public health and communication (ognyanova et al. ) . n = studies and reports explicitly witnessed rampant misinformation and its impacts on minorities worldwide (posetti and bontcheva ) . these results are compatible with the world health organization (who ), declaring misinformation as an equally challenging phenomenon (vicol ) . similarly, most cited studies witnessed social media as a primary source of misinformation due to increased online media dependence (ali ) . these results are consistent with the study conducted by brennen et al. ( ) , as they found a strong significant correlation between social media platforms (facebook, youtube & twitter) and fake news. also validated by pulido, ruiz-eugenio, et al. ( ) , as they stated that although globalization plays a vital role in spreading healthcare information, social networking platforms also contain misinformation. covid- is a dominant part of online discourse, and harmful, personal, and opinionated content adversely affects the current situation. misinformation is a critical risk for global health and well-being, and during the covid- outbreak, people are unable to find any unreliable source of information (tedros adhanom ghebreyesus ). likewise, much of the information we receive from social media resources are unreliable (orso et al. ) . the situation gets worst when users re-share the news without further confirmation (mian and khan ) . as noted by islam et al. ( ) , social media platforms facilitate users to share information of their choice, enjoying the freedom, and represent their opinion. this lack of control over thoughts further amplified radical thinking and claimed to be significant misinformation (tucker et al. ) . conspiracy beliefs raised by misinformation adversely affected the efforts to mitigate the impacts of covid- and minorities worldwide (barua et al. ) . the cited literature also witnessed these impacts, mainly resulting in xenophobia, lgbt rights violation and, several psychological disorders (ravi philip rajkumar ; rzymski and nowicki ; lokot and avakyan ). according to international laws, the extraordinary situation requires extraordinary measures that means many fundamental rights, including access to information, freedom to opinion, and freedom to impart the information, restrict the media resources to spread correct information regarding covid- (accessnow.org ). for this purpose, healthcare organizations and individuals are equally obligated to spread correct information and government resources (toppenberg-pejcic et al. ) . to counteract against the impacts of misinformation, it is essential to: however, as both traditional and digital media platforms are accessible today, it is difficult to curb the misinformation. especially interconnected-ness through new media and mobile technology is identifying the resources, and mitigating the impacts of misinformation are the significant challenges (sharma et al. ) . particularly, misinformation during the current pandemic amplified more significant concerns hindering the global efforts to overcome the outbreak (pennycook et al. ) . this multitude of "falsehoods" has even become a matter of life and death. for this purpose, stakeholders and media organizations have the responsibility to spread accurate, objective, and appropriate news as the misinformation hinders global healthcare efforts (usaid ). struggle to overcome the pandemic crucially depends on the public holding appropriate beliefs and attitudes. however, the novel corona virus outbreak is mostly accompanied by false information for the strategic gain on different media platforms, posing a threat to all the ongoing contributions (bursztyn et al., ; aspi, ) . for this purpose, besides counteracting against the covid- pandemic, social media pandemic also needs attention as both viruses and misinformation spread at the same pace, having the same impacts and challenging the global healthcare scenario today (depoux et al. ) . therefore, misinformation largely plagued the scientific efforts and communities during the current pandemic. a topic like safety measures, vaccination, disease origins, and others primarily contain myths. for instance, home remedies can cure the coronavirus. according to most of them, vitamin-c and garlic intakes are the miracle remedies to treat the disease (mian and khan ) . similarly, corona virus can spread through eyes, coronavirus is a humanmade virus for personal interests and terrorism, receiving packages and letters from china is not safe, and others (carpha ). this study also highlighted the widespread misinformation on different media platforms and their impacts. the world is mostly facing misinformation as covid- significantly amplified the growth and spread of misinformation through different media platforms. although the role of social media is prominent, traditional media platforms are also a source of spreading rumors and false beliefs. accompanied by hate speech, online bullying, and discrimination, misinformation is a significant challenge during the current pandemic. counteracting against the misinformation can help to mitigate the impacts of corvid- in the short-term. it will also help us "build back better" by addressing the primary cause of the outbreak by promoting common humanity, solidarity, unity, and inclusion (united nations ). in this regard, accuracy nudges should be the top priority for the media platforms to counter the tide of misinformation during the current pandemic positively. depending on the existing literature, this study is capable of increasing our knowledge regarding misinformation during the current pandemic. an extensive number of cited studies are significantly witnessing the rampant misinformation as a significant social challenge. furthermore, the researcher also proposed a graphical abstract that will support future researchers to examine misinformation and its impacts, especially during the significant healthcare crisis. this study does not contain any methodology or primary data, which limits its scope. similarly, a majority of citations from american investigation is another major limitation. however, the researcher carefully analyzed the gathered data and made the relevant conclusions. therefore, to further validate this phenomenon, the researcher recommends more studies to investigate the sources of misinformation during the healthcare crisis. 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misinformation: challenges and recommendations impact of rumors or misinformation on coronavirus disease (covid- ) in social media world health organization emergency risk communication: lessons learned from a rapid review of recent gray literature on ebola, zika, and yellow fever social media, political polarization, and political disinformation: a review of the scientific literature covid- and the human rights of lgbti people what is the impact of covid- on lgbti people ? frequently asked questions ( faq ) immunization in the context of covid- pandemic united nations guidance note on addressing and countering covid- related hate speech who is most likely to believe and to share misinformation? fe strengths, weaknesses, opportunities and threats (swot) analysis of china's prevention and control strategy for the covid- epidemic systematic literature review on the spread of health-related misinformation on social media coronavirus pathogenesis and the emerging pathogen severe acute respiratory syndrome coronavirus coronavirus disease . a & a practice portrayal of the human resource crisis and accountability in healthcare: a qualitative analysis of ugandan newspapers who -middle east respiratory syndrome coronavirus (mers-cov) summary and literature update-as of quality of literature review and discussion of findings in selected papers on integration of ict in teaching knowledge, attitudes, and practices towards covid- among chinese residents during the rapid rise period of the covid- outbreak: a quick online cross-sectional survey key: cord- -iz alys authors: francis, john g.; francis, leslie p. title: fairness in the use of information about carriers of resistant infections date: - - journal: ethics and drug resistance: collective responsibility for global public health doi: . / - - - - _ sha: doc_id: cord_uid: iz alys one standard menu of approaches to the prevalence of anti-microbial resistance diseases is to enhance surveillance, fund research to develop new antimicrobials, and educate providers and patients to reduce unnecessary antimicrobial use. the primarily utilitarian reasoning behind this menu is unstable, however, if it fails to take fairness into account. this chapter develops an account of the fair uses of information gained in public health surveillance. we begin by sketching information needs and gaps in surveillance. we then demonstrate how analysis of information uses is incomplete if viewed from the perspectives of likely vectors of disease who may be subjects of fear and stigma and likely victims who may be coerced into isolation or quarantine. next, we consider aspects of fairness in the use of information in non-ideal circumstances: inclusive participation in decisions about information use, resource plans for those needing services, and assurances of reciprocal support. fairness in information use recognizes the ineluctable twinning of victims and vectors in the face of serious pandemic disease. antimicrobials; and to intervene through education, treatment, and careful stewardship of the existing antimicrobials that retain some efficacy. this combination of approaches is founded primarily in utilitarian reasoning, attempting to achieve the best possible mitigation of the current crisis in the hopes that effective new treatment methods may soon become available. such utilitarian reasoning is not entirely stable in practice, however. on the one hand, when the prospects of exposure to untreatable and potentially fatal disease appear imminent, fear may become the overriding reaction to those who are identified as ill. the result may be forms of coercion against people suspected of being vectors of disease that appear prudential in the short term but that are insufficiently grounded in science and potentially counter-productive in the longer term. people may hide to avoid disclosure and deleterious consequences of over-regulation may lead to under-regulation. recent examples include demands to compel isolation of people believed to have been exposed to ebola or for banning travel from regions where outbreaks of conditions such as ebola or zika have been identified. on the other hand, concerns for victims may generate outpourings of resources for treatment, calls for investment in public health resources in underserved areas, and renewed emphasis on privacy protections. these too may be counterproductive if they result in confusion and waste of resources or multiple conflicting strategies. the upshot may be policies that oscillate between treating people as vectors and treating them as victims but without significant or coordinated progress against the problem of resistance. each of these perspectives-victim-hood and vector-hood-is morally important. but in our judgment analysis that is limited to these perspectives is incomplete in its failure to take certain considerations of fairness into account. our specific focus here is the use of information, but similar points could be made about other types of resources as well. collection, uses, and access to information, we contend in what follows, must be rooted in the effort to make progress against serious public health problems in a manner that is reasonably fair under the circumstances. this requires not only concern for people as victims and vectors but concerns about how the impact of policies are distributed and foster cooperative connections in both the shorter and the longer term. traditional public health surveillance methods are both individual and population based. where particular individuals are concerned, the role of information is primarily to enable strategies to interrupt disease transmission. case identification, case reporting, contact tracing, treatment if possible, and education and intervention if needed to prevent transmission come to the fore. at every stage, information is critical. if individuals with transmissible disease are unknown or cannot be located, efforts to interrupt transmission will fail. efforts will also fail if information is not transmitted to those who are capable of acting, whether they be authorities designated to enforce quarantine or isolation or health care personnel equipped to offer treatment or prophylaxis. education requires information, too, about where to direct educational efforts and what these efforts might contain. importantly, if people who might suffer exposures are insufficiently informed about the likelihood and seriousness of contagion and the need for precautions, they may unwittingly become infected vectors as well as victims themselves. such was the case for health care workers during the sars epidemic of and for many during the ebola epidemic of . information gleaned in population-level surveillance plays many additional important roles in addressing the problem of anti-microbial resistance. a longstanding recommendation of the who, codified in the world health regulations that entered into force in in article , is international cooperation in the development of surveillance capacities for the identification of potential global health emergencies of international concern (who ). surveillance can help to identify rates of incidence and prevalence of resistant disease. testing samples can yield information about histories and patterns of disease spread. samples also can be used to identify biological characteristics of resistant infectious agents that may be helpful in developing methods of treatment or identifying new anti-microbial agents. population level surveillance can be targeted to identifying the incidence and prevalence of resistant disease in particular geographical areas. gonorrhea is an example. there were . million estimated new cases of gonorrhea worldwide in ; the highest number occurred in low-income areas of the western pacific. resistant disease has become increasingly prevalent, especially in these areas and among groups such as sex workers and truck drivers (unemo et al. ) . extensively drug-resistant (xdr) gonorrhea cases also have appeared in spain and in france, although these strains do not appear to have spread, possibly because they are less hardy and so less likely to be passed on. however, significant resistance may not be detected because of "suboptimal antimicrobial resistance surveillance in many settings" (unemo et al. ) . a recent international panel reviewing resistant gonorrhea recommends strategies of case management, partner notification, screening (especially of sex workers and men having sex with men), and evidence-based treatment (unemo et al. ) ; these recommendations are based on surveillance data. population-level surveillance information may also be useful in identifying risks associated with providing humanitarian treatment. over , young people wounded in the libyan civil war that began in were evacuated elsewhere for treatment. concerns arose that many of these patients were recognized to carry with them resistant organisms-thus bringing along with their needs for treatment risks to other patients being treated in the host facilities (zorgani and ziglam ) . institutions accepting these patients were informed of this risk so that they could take appropriate precautions. libya itself was identified as a region with high prevalence of resistant organisms, despite the limited surveillance capacities in that conflict-torn nation. recommendations included improving surveillance in libyawhich lacks a national surveillance system-and implementation of infection prevention measures in libyan hospitals. surveillance is also used to identify practices that might contribute to the development of resistance. use of antimicrobials in agriculture is one area of inquiry, although its precise contribution to the problem is not easy to quantify (e.g. hoelzer et al. ). there have been many studies of problematic prescribing practices among physicians in the us (wigton et al. ) , europe (e.g. jørgensen et al. ) , asia (lam and lam ) , and elsewhere (trap and hansen ) , along with efforts to educate physicians about appropriate antimicrobial use. ever since the recognition grew that crowds celebrating the return of soldiers from world war i had created a ready opportunity for transmission of the spanish influenza, epidemiologists have observed the potential health risks of large gatherings that concentrate people together, even for brief periods of time. examples include music festivals, major sporting competitions, other large festivals, and religious gatherings such as the hajj or other pilgrimages. the largest estimated gathering is the periodic kumbh mela pilgrimage in which hindus come together to bathe in a sacred river such as the ganges; over million people, drawn largely from the indian subcontinent but increasingly international, attend the event (gautret and steffen ) . the largest annual gathering of pilgrims is the hajj at mecca which draws over two million people; the fifth pillar of islam is the obligation to undertake the once in a lifetime journey for those who can physically or financially afford to do so. with such great numbers of people together for sustained periods of time, there is a risk of disease outbreaks and the spread of resistant infections. such events may strain existing sanitation systems or health care facilities if people become ill. crowding and inadequate facilities contribute to the potential for disease outbreaks (gautret and steffen ) . these events draw people from around the globe and thus may result in the international spread of disease (gautret and steffen ) . at the same time, many of these events are of great cultural importance and suppression of them is neither a realistic nor a desirable option. there have been extensive discussions of how to address the public health needs of the great numbers of people who undertake pilgrimages or who attend other events that draw great numbers of people together. vaccination may create herd immunities that reduce risks of disease transmission; for example, for this year's hajj the saudi arabian government is requiring proof of a quadrivalent meningococcal vaccination in order to receive a visa (ministry of hajj ). nonetheless, risks may remain significant for conditions that cannot currently be addressed by vaccination or that are difficult to treat, such as middle east respiratory syndrome coronavirus (mers-cov) or resistant infections. information too is critical: such well-attended events require imaginative and thoughtful surveillance that informs short-term medical care. because saudi arabia has had the largest number of human cases of mers-cov-an estimated % (who b)-travelers for this year's hajj are being warned to take extra precautions with respect to sanitation and personal hygiene measures such as handwashing or avoiding direct contact with non-human animals (new zealand ministry of foreign affairs ). still other social factors may contribute to the development of resistant disease that can be identified through surveillance. given the difficulties for women in saudi arabia to see physicians without being escorted, it is understandable that in saudi arabia many community pharmacies will dispense antibiotics without a prescription. zowasi ( ) recommends addressing these issues by increased education especially through social media as to the best approach to respond to the risk of anti-microbial resistant organism. still other recommendations about information use involve research on the development of new forms of antimicrobials. according to the most recent review article (butler et al. ) , antibiotics "are dramatically undervalued by society, receiving a fraction of the yearly revenue per patient generated by next-generation anticancer drugs." they are in the judgment of these authors an "endangered species,"-but there is some faint encouraging news. who and a number of national governments have recently begun to direct attention to the potential threat of resistance and lack of new drugs. since , five new-in-class antibiotics have been marketed, but these unfortunately only target gram-positive organisms not the gram-negative organisms that are likely to be resistant. other compounds are also in various stages of the process of clinical trials, but these too are more likely to be active against gram-positive bacteria. in the judgment of the authors of this review article, "the acute positive trend of new approvals masks a chronic underlying malaise in antibiotic discovery and development." interest in antibiotic development is more likely to be present in smaller biotech companies and in biotech companies located in europe. the authors conclude: "the only light on the horizon is the continued increase in public and political awareness of the issue." they also observe that with the retrenchment in investment, "we potentially face a generational knowledge gap" and drug development "is now more important than ever." to address this perilous juncture in antimicrobial research, the pew charitable trust convened a scientific expert group in . the premise of the group was that regulatory challenges, scientific barriers, and diminishing economic returns have led drug companies largely to abandon antibiotic research-yet antimicrobial resistance is accelerating. no entirely new classes of antibiotics useful against resistant organisms have been brought to market that are not derivatives of classes developed before -over years ago. the pew report advances many explanations for this dismal situation, including importantly the lack of coordinated investment in the relevant basic and translational research. one aspect of the report detailed the major role played by information gaps. published research is out of date and out of print. moreover, in today's world of investment in drug discovery, "creating an environment in which data exchange and knowledge sharing are the status quo will be difficult given proprietary concerns and the variety of information types and formats, which may range from historical data to new findings produced as part of this research effort." the pew consensus is that the following forms of information sharing are needed: a review of what is known about compounds that effectively penetrate gram-negative bacteria, a searchable catalogue of chemical matter including an ongoing list of promising antibacterial compounds, information on screening assays and conditions tested, and an informational database of available biological and physicochemical data. mechanisms must also be developed for sharing drug discovery knowledge in the area (pew, . in line with pew, a european antimicrobial resistance project suggests that research is seriously underfunded (kelly et al. ) . this group argues that the bulk of the publicly funded research is in therapeutics ( %); among the remainder, % of the research was on transmission and only % specifically on surveillance. this group also concluded that research is not coordinated and there is little attention to data sharing or sharing of research results. funding is fragmented, too, with many smaller grants addressing smaller projects independently rather than in a way that builds. this group summarizes: "to conclude, investment at present might not correspond with the burden of antibacterial resistance and the looming health, social, and economic threat it poses on the treatment of infections and on medicine in general. antibacterial resistance clearly warrants increased and new investment from a range of sources, but improved coordination and collaboration with more informed resource allocation are needed to make a true impact. hopefully, this analysis will prompt nations to pay due consideration to the existing research landscape when considering future investments." additional recommendations from other groups include novel methods for management of resistant disease, such as addressing the intestinal microbiome (e.g. bassetti et al. ) ; these methods, too, may be furthered by surveillance information as well as information about individual patients. analysis of these uses of information from the perspective of vector or victim are, we now argue, incomplete. when contagious diseases are serious or highly likely to be fatal and treatments for them are limited at best, fear is understandable. fear may be magnified if the disease is poorly understood, especially until modes of transmission have been identified. fear may also be magnified if there are no known effective treatments for the disease, as may be the case for extremely drug resistant infections. it is therefore understandable that proposals may come to the fore that emphasize isolation of those who are known to be infected, quarantine of those who have been exposed, or travel bans from areas of known disease outbreaks. proposals may even include criminalization of those who knowingly or even negligently take risks of infecting others. all of these possibilities and more were features of the hiv epidemic. even as understanding of the disease grew and effective treatment became increasingly available, some of these remain. criminalization of hiv transmission has not waned, despite the many objections raised to it (e.g. francis and francis a, b) . although the us ended its immigration ban on hiv+ individuals in , concerns remain about the risks of undiagnosed infections among immigrant populations in the u.s. (winston and beckwith ) and some countries (for example, singapore) continue to ban entry for hiv+ travelers planning stays over thirty days (the global database ). as epidemic fears have waxed and waned over recent decades, so have imperatives for identifying vectors and constraining their activities. these patterns have been apparent for avian influenza, sars, ebola, and zika, among others. the us still bars entry by non-citizens with a list of conditions including active tb, infectious syphilis, gonorrhea, infectious leprosy, and other conditions designated by presidential executive order such as plague or hemorrhagic fevers (cdc ). indeed, resistant tb has been a frequent illustration of the vector perspective in operation. multi-drug resistant tuberculosis is transmissible, difficult to treat, and poses a significant public health problem. its presence can be identified by methods such as testing of sputum samples. when patients are identified with resistant disease, public health authorities may seek to compel treatment or isolation, especially for patients judged unreliable about compliance with treatment. to avoid transmission, public health authorities have proposed isolating patients who have been identified as infected. because a course of treatment for tb may take many months-and failure to complete the full course may increase the likelihood of resistant diseaseisolation may continue for long periods of time. controversially, during the early s public health officials in new york isolated over patients identified with mdr tb on roosevelt island for treatment out of concern that they would be noncompliant with treatment even when they were unlikely to infect others (coker ) . perhaps one of the most highly publicized events involving a single patient was the odyssey of andrew speaker, a lawyer believed to have extremely resistant tb who eluded authorities as he took airplane flights around the globe in the effort to return home. speaker's journey created an international scare and calls for travel restrictions. speaker's lawsuit against the centers for disease control and prevention alleging violations of the federal privacy act, he claimed by revealing more information than was necessary for public health purposes, was ultimately resolved on summary judgment for the government, largely because the challenged disclosures had been made by speaker himself. who travel guidelines provide that individuals known to be infected with resistant tb should not travel until sputum analysis confirms that they are not at risk of disease transmission (who ). evidence is limited, however, about the need for this policy. the most recent literature review suggests that risks of transmission during air travel are very low and that there is need for ongoing international collaboration in contact tracing and risk assessment (kotila et al. ) . blanket travel bans encouraging actions that elude detection may reduce, rather than enhance, this needed collaboration. more subtle policies tailored to need would be preferable, but the fears generated by a focus on fear of vectors may make them unlikely to be developed or implemented. at best, therefore, the vector perspective is incomplete. focus on it may be counter-productive, if people hide or try to avoid education. it may encourage expenditures on efforts to identify suspected vectors rather than on evidence based efforts to identify risks of transmission and effective modes of prevention. and, of course, it ignores the plight of victims, to which we now turn. people with resistant infections are not only vectors, they are also victims of disease and have ethical claims to be treated as such (battin et al. ) . indeed, it is likely that vectors will themselves be victims, unless they are carriers of the disease in a manner that does not affect them symptomatically. concern for victims may take the form of seeking to ease the burdens of constraints such as isolation. a good illustration of the victim perspective in operation is the who publication of a pamphlet on "psychological first aid" to those affected by ebola. the pamphlet is designed to provide comfort to and meet the basic needs of people infected by ebola and those who are close to them, while maintained the safety of aids workers (who ). the recommendations rest on the importance of respect for the dignity of those who are suffering amidst disease outbreaks. it also emphasizes the importance of respect for rights such as confidentiality and nondiscrimination. the pamphlet is provisional and designed to be updated as knowledge of safety measures improves; this provisional nature is a recognition of the importance of ongoing development of information about how victims' needs can be safely met. despite the concern for victims, foremost in the pamphlet's recommendations is safety, both of aid workers and of disease victims, so that no one is further harmed including victims themselves and others close to them. overall, the pamphlet attempts to counter impulses to come to the aid of victims that may increase transmission risks, such as unprotected contact with those who are ill. but unexplored tensions remain in the document's recommendations. for example: "respect privacy and keep personal details of the person's story confidential, if this is appropriate" (p. ). nowhere does the document discuss when confidentiality is appropriate or what personal details may be revealed and in what ways. its manifest and important concern for victims is countered by safety but without discussion of how these goals might be implemented together or reasonably reconciled in practice. the who's most recently-adopted strategy for dealing with health emergencies, the health emergencies programme, provides another illustration of concern for victims that may lie in unexplored tension with other values. the programme urges cooperative methods to meet the immediate health needs of threatened populations through humanitarian assistance while also addressing causes of vulnerability and recovery (who ) . it is a coordinated strategy for emergency response that will move far beyond merely technical help; who describes it as a "profound change for who, adding operational capabilities to our traditional technical and normative roles" (who ) . it is aimed to provide crisis help, such as to hurricane matthew in haiti or to areas affected by the zika virus. it requires a major increase in funding devoted to core emergency efforts. core funding will come from assessed contributions, flexible contributions that the director-general has discretion to allocate, and earmarked voluntary contributions. but it is clearly under-funded; who reported a % funding gap as of october , just to meet the program's core capabilities. moreover, who also reported that it has raised less than a third of the funding needed for the who contingency fund for emergencies, a fund deployed for the initial months of an emergency before donor funding becomes available (who ) . the health emergencies programme reflects reactions to the humanitarian disaster of the ebola epidemic and criticisms of the who level of response. the who - budget reflects this response as well (who ) . that budget "demonstrates three strategic shifts" (who , p. ). the first is application of the lessons from ebola especially the need to strengthen core capacities in preparedness, surveillance and response. the second strategic shift is a focus on universal health coverage, which includes enhancing contributions to maternal and child health, speeding progress towards elimination of malaria, and enhancing work on noncommunicable diseases, among other worthy goals. the final strategic shift is towards "emerging threats and priorities"; illustrations of these are "antimicrobial resistance, hepatitis, ageing, and dementia." these are not an obvious group to characterize as "emerging," to the extent that this suggests a developing threat that has not yet become urgent but that may be expected to become so in the near future. nor are they an obvious group to link together in the same category. this mixture of budgetary priorities suggests is responsiveness to issues raised through consultation with who member states, rather than proactive planning. who specific efforts directed to resistance can be characterized as primarily coordination. the who website devoted to resistance promotes information sharing and lists research questions and potential funding agencies (who a). who expresses no judgment about either funding agencies or which of the nearly listed research questions-ranging from research on resistance in day care centers to the biological price that microorganisms pay for resistance-might be fruitfully addressed first or how they might be interconnected. concern for victims is surely part of a response to a humanitarian emergency. responsiveness to urgent health needs is an important goal. including antimicrobial resistance in a list of "emerging" issues is at least recognition of the problem. but the who response to ebola and the who budget overall can be characterized as less than fully set into context in a reasoned way. thus, we contend, neither vector nor victim perspectives are adequate. one risks falling prey to fear while the other risks responses that are well-intentioned but that may be difficult to meet or compete with other values in ways that remain underexplored. these perspectives are inevitable and important, but they are each incomplete. in our judgment, a primary difficulty with both vector and victim perspectives is that neither are set into context or seen as interconnected. this section suggests how fairness considerations may help in focusing attention to the most pressing questions to ask about antimicrobial resistance and the directions for surveillance and information use to take. fairness entered the philosophical lexicon in discussions about justice as procedural, most famously in john rawls's "justice as fairness" (rawls ) . as rawls initially conceptualized his view, it involved a decision procedure for selecting basic principles of justice in which people were unable to gain unfair advantage. as the debates about rawlsian justice unfolded, a fundamental issue was whether people with radically different capacities and views of the good life could be expected to accept the results of the decision procedure as formulated. thus critics raised the concern that people with disabilities might be left out of the decision procedure as "non-contributors" to the practice of justice (nussbaum ; stark ) . critics also pressed the argument that people with radically illiberal conceptions of the good would ultimately destabilize the practice of justice in a rawlsian ideal society (e.g. williams a, b) . rawls ultimately accepted the point that proceduralism could not yield a universal theory of justice, pulling back his view to the claim that it only represented a vision of justice for a certain kind of liberal society (rawls ) . but fairness also entered the debates about justice in a more substantive way, especially in bioethics. norman daniels ( ) , for example, expanded a rawlsian approach to consider justice in health care. the british idea of a "fair innings," in which the opportunities of each to reasonable health over a normal life span are prioritized, was raised particularly with respect to the distribution of health care resources to the elderly (bognar ; farrant ; harris ; williams b) . like the metaphor of a level playing field, the fair innings argument comes from sports (francis ) . it reflects the idea of everyone having a chance to participate in a game that at least gives them a reasonable opportunity for success. there are four aspects of such opportunity: who plays and whether the rules are constructed to give each an opportunity to win that is reasonable are two. also important is the balance among opportunities to succeed, so that there aren't consistent tilts in one direction or another, as might be characterized by the further metaphor of leveling the playing field. finally, attention to the interaction between advantages and disadvantages matters, so that participants are encouraged to continue playing the game rather than dropping out. our invocation of fairness as a concept is rooted in the judgment that antimicrobial resistance-or other pressing global public health problems, for that matterexemplify multiple aspects of non-ideal and partial compliance circumstances. natural circumstances are less than forgiving; new health threats emerge on a regular basis. antimicrobial resistance is an ongoing natural challenge to effective therapy for deadly diseases. social circumstances are imperfect, too: overcrowding, poor sanitation, straitened resources for public health and health care, and cultural practices that increase potential for disease transmission all play roles in the development of resistance. alexander fleming, the discoverer of penicillin, warned that the development of resistance was likely, but his warning appears not to have been well heard. finally, efforts to address antimicrobial resistance are riven with noncompliance: over-prescribing by physicians, over-use of antimicrobials in agriculture, individual failures to take medications as prescribed, and concealment of disease out of fear of discovery and persecution. because the conditions that give rise to these problems of non-compliance may seem urgent-people seeking antimicrobials are in pain or ill, perhaps gravely; people in hiding from health authorities may fear stigmatization or death-they raise in particularly poignant form questions of the extent of obligations under circumstances in which others are not doing what arguably is their fair share (e.g. stemplowska ; murphy ) . fairness as an ethical concept is especially suited to such imperfect circumstances. it directs attention to how improvements are distributed. distributions can be more or less fair, if they distribute benefits and burdens in an increasingly inclusive manner (e.g. francis and francis a, b) . fairness thus construed is at the heart of perhaps the most influential set of recommendations for ethical pandemic planning, the canadian stand on guard for thee (toronto joint centre ) . although much of the discussion of fairness in this document emphasizes inclusive procedures, so that engagement may lead to acceptance of choices as fairly made (e.g., p. ), the recommendations also contain substantive dimensions. these include fair resource plans for those who fall ill providing necessary services during a pandemic (p. ) and assurance that people who are affected by choices are reciprocally supported in a way that they do not suffer "unfair economic penalties" (p. ). here, the links between fairness and reciprocity are explicit. these four aspects of fairness-who is included in the play, what opportunities they have, how these opportunities are balanced, and whether there are elements of reciprocity-can be used to set vector and victim perspectives into context in addressing the gathering and use of information about antimicrobial resistance. over-emphasizing vectors threatens their opportunities and even possible participation. overemphasizing victims tilts the field unidirectionally, understandably directing resources to immediate need but without consideration of longer-term consequences. reciprocity may be the most important of all, creating commitment to workable strategies for addressing resistance when there are difficult choices to be made. fear, understood as a threat personal health, is often an ally in persuading people to seek preventive care and to change life styles, or to persuade policy makers to create incentives or penalties for decisions that contribute to poor health. but great fear can also lead to immobility. the real threat posed by the rise of antimicrobial resistance does not seem to be easily addressed by a successful alternative in the view of victims or policy makers. medical personnel are fearful of not responding to the demands of patients for immediate reductions in pain or suffering at relatively low costs. the scale of the threat posed by rapid rise of antimicrobial resistance may be daunting to policy makers especially as funders of research. the cost of developing ever-new generations of antibiotics seems to suggest a great series of short-term solutions especially as pharmaceutical companies respond to incentives to generate near-term profits. in this context, it is worth recalling how the development of the first antimicrobials contributed to more generally shared benefits: when penicillin became known to people as a wonderful drug it actually helped to speed the adoption of the national health service in britain. the popular expectation was health care for all facilitated with the rise of a new generation of low cost wonder drugs and reinforced by low cost vaccinations (webster ) . but some of the advantages were short-lived, as the costs of pharmaceuticals grew exponentially and inadequate attention was paid to the risks of overprescribing-once again a cautionary reminder of the importance of emphasizing balance rather than one particular perspective such as victimhood. if a promise of sustaining production at lower costs of ever-new generations of antimicrobials from how information is used can offer benefits more widely, then it becomes easier to impose tougher regulations on antimicrobial use that may to some extent stave off the development of resistance. this approach in terms of fairness directs attention not only to vectors and to victims seen as separate entities. it also directs attention to how they are often, and unpredictably, twinned-given the epidemiology of resistance spread, it is likely to begin within interlaced communities where vectors are also victims. but it also directs our attention to these issues set in distributive context, raising questions such as these: who is most likely to be affected by resistance? who will suffer the most severe consequences from resistance? who is most likely to be disadvantaged by information gained to counter resistance? who will suffer the most severe disadvantage? who will benefit from efforts to counter resistance? how can these benefits be spread more inclusively? and, how are the benefits and burdens of addressing resistance intertwined? are some primarily beneficiaries, while others are primarily burdened? are there ways to increase reciprocal linkages in these benefits and burdens, so that efforts to counter resistance are accepted and supported more widely? these are the kinds of questions that need to guide how surveillance is deployed in the effort to counter resistance, not vague generalities about the importance of addressing health infrastructure or bromides about the need to increase resources. open access this chapter is licensed under the terms of the creative commons attribution . international license (http://creativecommons.org/licenses/by/ . /), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence and indicate if changes were made. the images or other third party material in this chapter are included in the chapter's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the chapter's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. georgia: suit against disease centers is revived. the new york times antimicrobial resistance in the next years, humankind, bugs and drugs: a visionary approach the patient as 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perceptions of value prior to use. few studies have assessed factors associated with the value of hie through its actual use. this study investigates provider perceptions on hie comparing those who had prior experience vs those who had no experience with it. in so doing, we identify six constructs: prior use, system complexity, system concerns, public/population health, care delivery, and provider performance. this study uses a mixed methods approach to data collection. from interviews of medical community leaders, a survey was constructed and administered to clinicians. descriptive statistics and analysis of variance was used, along with tukey hsd tests for multiple comparisons. results indicated providers whom previously used hie had more positive perceptions about its benefits in terms of system complexity (p = . ), care delivery (p = . ), population health (p = . ), and provider performance (p = . ); women providers were more positive in terms of system concerns (p = . ); patient care (p = . ), and population health (p = . ); providers age – were more positive than older and younger groups in terms of patient care (p = . ), population health (p = . ), and provider performance (p = . ); while differences also existed across professional license groups (physician, nurse, other license, admin (no license)) for all five constructs (p < . ); and type of organization setting (hospital, ambulatory clinic, medical office, other) for three constructs including system concerns (p = . ), population health (p = . ), and provider performance (p = . ). there were no statistically significant differences found between groups based on a provider’s role in an organization (patient care, administration, teaching/research, other). different provider perspectives about the value derived from hie use exist depending on prior experience with hie, age, gender, license (physician, nurse, other license, admin (no license)), and type of organization setting (hospital, ambulatory clinic, medical office, other). this study draws from the theory of planned behavior to understand factors related to physicians’ perceptions about hie value, serving as a departure point for more detailed investigations of provider perceptions and behavior in regard to future hie use and promoting interoperability. health information exchange (hie) has been described in various ways in the literature, but is generally understood as the act of health information sharing, facilitated by computing infrastructure, that is conducted across affiliated physicians' offices, hospitals, and clinics; or between completely disparate health systems (furukawa et al. ) . hie across disparate systems allows clinical information to follow patients as they move across different care settings, whether or not each organization shares an affiliation. this might include a hospital connected to an hie that is, in turn, connected to other forprofit and not-for-profit hospitals, private practices, and clinics. hie is expected to transform the nation's healthcare system through access to patient data from electronic health records to support care provision and coordination and improve care quality and population health (berwick et al. ) . health information exchange has also been described in terms of the organizational and technical environment facilitating hie. in this paper, hie is the act of exchanging health information facilitated by a health information exchange organizational and technical environment. while expectations and promises are high, still relatively little is known about the real and perceived value of hie by providers, and how to accomplish large-scale acceptance and use. it has been reported that about two-thirds of hospitals and almost half of physician practices are now engaged in some type of hie with outside organizations (rahurkar et al. ) . relatively few of the more than operational u.s. health information exchanges have been the subject of published evaluations (rudin et al. ) . after more than a decade of hie hype, utilization by users is still relatively low. a review of hie past research indicated that most studies reported use of hie in % to % of encounters (rudin et al. ). further, findings from a review of research on hie sustainability suggest that just one quarter of existing hie organizations consider themselves financially stable (rudin et al. ) . a systematic review of hie studies suggests that study stakeholders claim to value hie. yet, the effects on a wide range of outcomes are still unknown (rudin et al. ) , and little generalizable evidence currently exists regarding sustainable benefits attributable to hie (rahurkar et al. ) . some have noted the potential for widespread hie adoption to reduce the utilization and cost of healthcare services richardson ) , though empirical evidence is limited (bailey et al. ; fontaine et al. ) . continued research is needed to understand the factors associated with adoption and use of such a promising, yet underutilized technology. to date, most hie studies have investigated user perceptions of value prior to use, and the intention to use. few studies have assessed factors associated with the value of hie through its actual use. this study investigates provider perspectives on hie comparing those who had prior experience vs those who have only heard of hie, but not yet had experience with it. the purpose of this study is to investigate provider perceptions about hie, comparing those who have used hie to those who have not used hie and how perceptions differ. the objectives of this study are to explore demographic differences in perceptions across different types of providers, assessing several important factors related to the adoption of health it. literature has determined that factors associated with perceived benefits and challenges of health it adoption and use include: ) the extent to which users perceive a system to be complex vs easy to use (davis ; gadd et al. ) , ) technical standards and business concerns that act as barriers to system use (rudin et al. ) , ) the perceived effects that using a system (and its information) has on public or population health (zech et al. ; shapiro et al. ; hincapie and warholak ; hessler et al. ; dobbs et al. ) , ) the perceived effects that using a system (and its information) has on patient care delivery (frisse et al. ; furukawa et al. ; kaelber and bates ) , and ) the perceived effects that using a system (and its information) has on provider performance (davis ) . we review these factors below as well as the literature on prior use of an information system: or the effect of prior use vs nonuse on perceptions and expectations of a system. prior use of an information system has been found to be associated with the intention to use them in the future (jackson et al. ; agarwal and prasad ) . prior it usage behavior tends to be a significant determinant of future usage intention and/or behavior (jasperson et al. ) . prior behavior helps form habit, which induces future behavior in an unthinking, automated, or routinized manner, rather than through a conscious process of cognitive or normative evaluation (eagly and chaiken ; triandis ) . accordingly, future behavior can be viewed as a joint outcome of behavioral intention and habit. though the indirect effects of prior use have seen little investigation in the literature, preliminary evidence to that effect has been reported (taylor and todd a, b) . these authors argued that as individuals gain familiarity with using a given technology (by virtue of prior use), they tend to focus less attention on the amount of effort needed to use the technology, and more on ways in which the technology can be leveraged to improve their job performance and outcomes. the familiarity with the technology gained from prior usage experience and the knowledge gained from learning-by-doing allows users to form a more accurate and informed opinion of the true performance benefits of the target system and its relevance to their job performance. hence, users' performance expectancy tends to become stronger as their prior use of technology increases. we extend this line of reasoning for business information systems to the case of providers' use of health information technology, or in this case, hie. hie is particularly interesting as a unique and differing context from business due to the multi-organizational, distributed, and shared healthcare information technology setting. perceived system complexity, or the degree to which a person believes that using a particular information system would be difficult vs easy or free of effort, has long been used as a construct to assess user acceptance of information technologies (davis ) . studies on ease of use have included a range of health information technologies including electronic health records (ehr) (dünnebeil et al. ; hennington and janz ) , telemedicine (hu et al. ) , clinical information systems (paré et al. ) , and others. many studies on hie ease of use have focused on the perceptions of prospective users not currently using hie. in one such study, . % of physicians interested in hie, but not currently engaging in hie, perceived that using hie would be easy . in contrast, . % of physicians not interested in hie perceived that using hie would be easy ). in the past, ease of use of hie has been positively predictive of system adoption and usage , and has shown to impact successful retrieval of patient information that affected patient care (genes et al. ) . of significant importance for this study is understanding perceived ease of use from users who have actually used hie vs. those who have not. some past studies have found several concerns that providers have in terms of using hie. a meta-analysis of studies showed that stakeholders consider hie to be valuable, but barriers include technical performance, workflow issues, and privacy concerns (rudin et al. ) . concerns also include limits on the amount and type of information that providers want to use , and general fears of information overload from ill designed systems and/or utilization of duplicate or seemingly "competing" information systems (rudin et al. ) . for example, in one study, quality assurance (qa) reports generated by a health information exchange for medical practices was reported as the least valued system function due to skepticism about report validity and concerns that reports would reflect negatively on providers . another study found that hie usage was lower in the face of time constraints, questioning whether hie may be considered an information burden rather than a help to users vest and miller ) . time constraints, especially in primary and emergency care, have also tended to be a cause for concern in engaging in hie. mixed results from hie evaluations have further raised concerns about its utility. for example, one study found that increased hie adoption has been associated with reduced rates of laboratory testing for primary and specialist providers (ross et al. ). yet, in the same study, imputed charges for laboratory tests did not shift downward (ross et al. ) . this evidence led us to include health information exchange system concerns as an important construct for hie provider perceptions and usage. prior studies have indicated the potential for hie to aid in a range of population health and care coordination activities, care quality, and timely health maintenance and screening. in one study, hie was shown to enable identification of specific patient populations, such as homeless (zech et al. ) , and those who have chronic or high risk health conditions ). however, not all studies have showed significant results related to population and patient health outcomes (hincapie and warholak ) . the authors in one study concluded that hie usage was unlikely to produce significant direct cost savings, yet also noted that economic benefits of hie may reside instead in other downstream outcomes such as better informed and higher overall quality care delivery (ross et al. ) . broader hie impacts include positive relationships with public health agencies (hessler et al. ), improved public health surveillance (dobbs et al. ) , and increased efficiency and quality of public health reporting ). thus, we assess user perceptions of the impact of hie on public/population health. the extent to which hie impacts the delivery of patient care has been addressed in prior studies. more generally, the timely sharing of patient clinical information has been shown to improve the accuracy of diagnoses, reduce the number of duplicative tests, prevent hospital readmissions, and prevent medication errors furukawa et al. ; kaelber and bates ; yaraghi ; eftekhari et al. ) . for hie specifically, usage has been associated with decreased odds of diagnostic neuroimaging and increased adherence with evidence-based guidelines (bailey et al. ). these include timelier access to a broader range of patient interactions with the healthcare system (unertl et al. ) , improved coordination of care and patient health outcomes for human immunodeficiency virus patients (shade et al. ) , and positive patient perceptions of the impact on care coordination (dimitropoulos et al. ) . providers continue to engage in hie with the belief that care delivery will improve (cochran et al. ) . further, benefits have been noted for specific care settings. emergency department access to hie has been associated with a cost savings due to reductions in hospital admissions, head and body ct use, and laboratory test ordering . further, hie has been associated with faster outside information access, and faster access was associated with changes in ed care including shorter ed visit length ( . min shorter), lower likelihood of imaging (by . , . , and . percentage points for ct, mri, and radiographs, respectively), lower likelihood of admission ( . %), and lower average charges ($ lower) (p ≤ . for all) (everson et al. ) . provider perceptions about the positive effects hie has on patient care delivery may be the strongest motivating factor for its adoption. for example, in one study, physicians most agreed that the potential benefits of hie lie in care quality and were least worried about the potential for decreases in revenues resulting from the technology (lee et al. ) . a study that looked at perspectives of home healthcare providers indicated a decrease in ed referral rates with hie (vaidya et al. ) . in another study, looking up clinical information (test results, clinic notes, and discharge summaries) on a patientby-patient basis was found to be the most valued function for hie users, followed closely by the delivery of test results, for the care of patients ). as such, perceived impact of hie on care delivery is included as a dependent variable. one expected outcome of using hie is that a performance improvement would occur. perceived usefulness is defined here as "the degree to which a person believes that using a particular system would enhance his or her job performance." (davis ) in sum, when a system is perceived to be useful, users believe positive performance will result. prior hie studies have shown that certain medical information is perceived to be more useful than others. one prior study found that physicians expressed agreement that hie is useful for pathology and lab reports, medication information, and diagnoses with chief complaints (lee et al. ). however, they expressed less agreement regarding the need for patient data items, functional test images and charts, care plans at the referring clinic/hospital, or duration of treatment (lee et al. ) . different studies reported that providers expected hie data would be useful to improve completeness and accuracy of patients' health records, efficiency with which clinical care is delivered, quality and safety of care, communication with other providers and coordination and continuity of care cochran et al. ) . prior studies have also indicated that quality patient information is believed to impact the elimination of duplicated medication as well as lab and imaging tests, prevention of drug-drug interactions, better decision making on the care plan and expedited diagnoses, and better ability to explain care plans to patients (lee et al. ) . physicians have noted that data gaps, such as missing notes, adequacy of training (cochran et al. ) , and timely availability of information (melvin et al. ) may pose a significant challenge to future hie usage (rudin et al. ) . while these perceptions of usefulness are important relative to expected hie use and resulting provider performance, we see expected and actual system use as scenarios that could potentially result in contrasting viewpoints. perceptions of provider performance that result from actual use of hie may provide a more real-to-life assessment. the objectives of this study are to explore demographic differences in perceptions across different types of providers, assessing several important factors related to the adoption of health it. our hypothesis is that provider age, gender, type of licensure (i.e., doctors, nurses), provider organizational setting (hospital, private practice), role in an organization (administration, patient care), and prior experience using hie are factors that affect provider perceptions about hie. for example, lee and colleagues (lee et al. ) found that different physician practice settings significantly influenced individual user perceptions. based on this information, this study is addressing differences in provider perceptions for different hie related constructs described above. the above research question was empirically tested using a field survey of practicing health providers in the state of virginia, usa. the specific technology examined was health information exchange and the action examined was hie. in march , the office of the national coordinator for health it (onc) awarded a state cooperative agreement to the virginia department of health (vdh) to govern statewide hie. in september , community health alliance (cha) was awarded a contract from vdh to build the virginia statewide health information exchange; connectvirginia was subsequently initiated to accomplish this goal. statewide health information exchanges were regarded as an organizational structure to provide a variety of mechanisms to enable hie using standardized technologies, tools, and m e t h o d s . d u r i n g t h e -m o n t h s t u d y p e r i o d , connectvirginia designed, tested, developed, and implemented three technical exchange services: connectvirginia direct messaging (a secure messaging system), connectvirginia exchange (the focus of this study), and a public health reporting pathway. connectvirginia exchange is a query/retrieve service in which a deliberate query passively returns one or more standardized continuity of care documents (ccds) that provide a means of sharing standardized health data between organizations on-boarded and connected to connectvirginia. the health information exchange design was based on a secure means to exchange patient information between providers via direct messaging, a secure means for query and retrieval of patient information via exchange, and a secure means for public health reporting. consistent with other health information exchange developments, a standardized product development lifecycle was used to create and implement the system. connectvirginia's direct and exchange protocols were originally established by onc and used as a method to standardize hie of secure messages and ccds. similar to the original nationwide health information exchange (nwhin) connect's exchange, connectvirginia's exchange involves pulling information by providers from an unfamiliar healthcare facility. connectvirginia's direct is a simplified version of the connect software that allows simple exchange of basic information between providers (dimick ) . the public health reporting pathway was established using secure file transport protocols. a survey questionnaire was developed and administered to physicians, dentists, nurse practitioners, registered nurses, physician assistants, and nurse midwives in virginia. we evaluated user perceptions of the hie using selected survey items. each clinician was given a summary of the study, the study protocol, consent procedure, and were notified that the research had been approved by the institutional review board of the lead researcher's university. each participant consented to participate and was assured their responses would be anonymous. the survey had three sections: ( ) demographics (age, job, gender) and system usage characteristics; ( ) familiarity with technology; and ( ) user perceptions across an author generated scale inclusive of the following constructs: system complexity, health information exchange system concerns, provider performance, patient care, and population care. a panel of experts reviewed items for face validity. we collected responses for all items on a scale of to from strongly agree ( ) to strongly disagree ( ). participants could also leave comments in several sections. purposive sampling was used to invite individuals, key informants, and thought leaders in the medical community to participate in -min interviews. fifteen interviews were conducted. from these interviews, a survey was created and administered to physicians, dentists, nurse practitioners, registered nurses, physician assistants, and nurse midwives. the sample was achieved from multiple sampling sources including two state medical societies and through a virginia medical providers e-rewards panel. e-rewards, a research now company, is one of the leading providers of online sampling in the u.s. product research industry. surveys were conducted via two channels: telephone and internet. e-rewards surveys were conducted by experienced telephone surveyors. in order to avoid survey bias, online and telephone surveys rotated questions. the goal was to achieve usable responses. over a -week period, invitations to participate in the survey and the survey link were distributed in monthly newsletters to qualified members of the medical society of virginia ( , members) and the old dominion medical society. old dominion medical society did not disclose the total number of members. this resulted in surveys, of which were usable. e-rewards panel members were called until completed and usable surveys were accomplished. combined, this yielded in usable surveys. ibm spss data collection was used to create and administer the survey online. data were collected from may through june . all surveys collected through telephone were entered into the online survey system as responses were collected. data were analyzed from the online and telephone versions of the survey together. internal reliability of the scale was calculated using cronbach's alpha and used the statistical package ibm spss v. for quantitative analyses. descriptive statistics were compared across demographics and usage characteristics. data were summarized using mean, median, and sd, and a sign test was used to determine if individual subscale items were significantly different from neutral. to determine the effects of our independent variables (prior use, gender, age, professional license, role in the organization, type of organization) on our dependent outcomes, an analysis of variance (anova) was used along with tukey hsd tests for multiple comparisons. the five constructs of interest to this study were health information exchange system complexity, system concerns, public/ population health, care delivery, and provider performance. each construct was measured using multiple-item survey questions, adapted from prior research, and reworded to reflect the current context of providers hie usage. the complete item scales are provided in table . system complexity was measured using four likert-scaled items adapted from davis' perceived usefulness scale (perceived usefulness is also referred to as performance expectancy in the information technology usage literature) (davis ). perceptions about system concerns were measured using items modified from taylor and todd (taylor and todd a, b) . the effect of hie on patient care delivery, public/population health, and provider performance was measured using investigator developed likert-scaled items guided by literature review. prior hie usage was measured using three items similar to thompson et al. (thompson et al. ) that asked subjects whether they had previously or currently used the system. we did not have access to actual system-recorded usage data, and thus, self-reported usage data was employed as a proxy for actual recorded usage. since the usage items were in the "yes/ no" format, in contrast to likert scales for other perceptual constructs, common method bias was not expected to be significant. we assess demographic factors including participant gender, age, and professional license (physician, nurse, other, administrative); role in the organization (patient care, administration, teaching/research, other); and type of organization (hospital, ambulatory clinic, medical office, other). these were all determined via selectable items in the instrument. each of the five constructs were tested for their reliability, or the extent to which each represents a consistent measure of a concept. cronbach's alpha was used to measure the strength of consistency. results of validation testing were found to be strong for patient care ( . ), provider performance (. ), and population care (. ); and moderate for system complexity (. ) and system concerns (. ). among responses, physicians indicated they had used hie previously and the remaining physicians indicated they had not yet used hie. respondents represented all clinical specialties, including internal medicine, pediatrics, gynecology, pathology, general surgery, anesthesiology, radiology, neurology, oncology, and cardiology. selected sample demographics, along with the population demographics for all providers at this hospital (obtained directly from the hospital administration), are shown in table . a one-way between subject's anova was conducted to compare statistical differences across demographic categories on each previously identified construct. demographic categories included: whether the participant had previously engaged with hie or not, gender, age grouping, professional license, role in the organization, and type of organization. constructs previously identified included health information exchange complexity, health information exchange system concerns, benefits of hie on patient care, population health, and provider performance. results from anova are shown in table . results indicated that there was a statistically significant difference between those that had previously used hie and those that had not used hie for four constructs. these included provider beliefs about the complexity (f( , ) = . , table . statistically significant differences between gender groups were found for three constructs including provider system concerns (f( , ) = . , p = . ); and perceived benefits on patient care (f( , ) = . , p = . ), and on population health (f( , ) = . , p = . ). statistically significant differences between age groups were found for three constructs including provider perceived benefits on patient care (f( , ) = . , p = . ), population health (f( , ) = . , p = . ), and provider performance (f( , ) = . , p = . ). statistically significant differences between professional license groups (physician, nurse, other license, admin (no license)) were found for all five constructs, including provider perceptions about system complexity (f( , ) = . , p = . ), provider concerns about use (f( , ) = . , p = . ), provider perceived benefits on patient care (f( , ) = . , p = . ), population health (f( , ) = . , p = . ), and provider performance (f( , ) = . , p = . ). statistically significant differences between type of organization setting (hospital, ambulatory clinic, medical office, other) were found for three constructs including provider concerns about use (f( , ) = . , p = . ), and provider perceived benefits on population health (f( , ) = . , p = . ), and on provider performance (f( , ) = . , p = . ). there were no statistically significant differences found between groups based on a provider's role in an organization (patient care, administration, teaching/research, other). an anova test is important to assess the significance of results; however, an anova test does not provide information about where the statistically significant differences lie for multiple comparisons (groupings for age, licensure, type of organization). in order to analyze which specific group means are different, tukey's hsd test is conducted for anova results with statistically significant f-values (tukey ) . tukey hsd post hoc comparisons indicated that the mean score for participants between to years old (m = . , sd = . ) was significantly different from participants over years old (m = . , sd = . ) for provider perceived benefits on patient care. these two age groups, respectively, were also significantly different in terms of perceived benefits on population health ( results from tukey hsd post hoc tests on type of organization indicated that participants whose primary work affiliation is with hospitals (m = . , sd = . ) were significantly different than those who identified with medical offices/ private practice (m = . , sd = . ) in terms of their concerns with using hie. results showed these two groups were . ( . )* . ( . )* . ( . ) . ( . )* . (. ) . ( . )* *the mean difference is significant at the . level also significantly different in terms of hie benefits on provider performance ((m = . , sd = . ) vs. (m = . , sd = . ), respectively). hospital based providers were less concerned and more positive towards performance benefits. results also indicated that ambulatory clinics (m = . , sd = . ) were significantly different from medical offices/ private practices (m = . , sd = . ) in their beliefs that hie benefits population health. the primary goal of this study was to identify differences in providers' perceptions related to hie based on their demographics and prior use of hie. a field survey was created based on provider interviews and administered to providers from different disciplines. the findings indicate that there were statistically significant differences in most hie perceptions based on demographics including prior hie use, gender, age, professional license, and type of organization. professional role in an organization yielded no statistically significant differences. the providers that had previously used hie showed more positive responses towards hie in each category except for the system concerns category. these results seem to support the business literature indicating that prior use of an information system has been shown to be associated with the intention to use it in the future, regardless of the amount of effort needed to use the technology (jackson et al. ; agarwal and prasad ) . there was a statistically significant difference in perceptions related to system complexity, system concerns, patient care, and population care between different genders, with females generally showing more positive responses than males for each category. depending on age groups, a statistically significant difference was observed for the patient care, population care, and provider performance constructs. interestingly, the middle group (ages to ) showed more positive responses than both the younger providers (less than years) and older providers (over years) for each category. while other studies have not looked at age by these constructs, this finding differs from literature suggesting that those years and younger are more likely to adopt ehrs (decker et al. ) . it could be that the hie context may be perceived differently than ehrs due to it being connective to and enabling of interoperability between ehrs. it could also be the size of the sample for each age group. in this sample, we have more providers that are in that middle age group compared to those that belong to the younger and older age groups. another potential way to explain this finding could be using the diffusion of innovation theory (kaminski ) . younger providers and older providers could be part of the later majority (conservatives) and may be less than enthusiastic at the beginning, as they could be waiting on statistically significant evidence before adopting and implementing new technology. the middle age group could be part of the visionaries or pragmatists as described in the diffusion of innovation theory and may be willing to be the trail blazers or risk takers (kaminski ) . statistically significant differences for all five constructs were noted across all professional license groups, which indicates that providers have different perceptions about hie depending on their discipline. in general, nurses reported the lowest scores about perceived complexity of hie, yet the highest scores in terms of system concerns. other licensed professionals reported the highest scores (high perceptions about hie task complexity). nurses and administrators reported the most positive scores on the benefits of hie for patient care, population health, and provider performance. doctors reported the least amount of concern with using hie, while nurses reported the highest amount of concern. statistically significant differences were noted for system concerns, population health, and provider performance constructs between different types of organizational groupings. the hospital based and "other organization" type groupings reported the least concerns about hie use and those working for medical offices reported the highest amount of concern. participants who reported working within ambulatory clinics reported the highest perceived benefit of hie on population health while those working within medical offices/private practice reported the lowest perceived benefit and this is consistent with the literature across a variety of ambulatory settings (haidar et al. ) . participants who reported working within hospitals reported the highest perceived benefit of hie on provider performance while those working in medical offices/private practice reported the lowest perceived benefit. the findings of this study should be interpreted in light of its limitations. the first limitation is our measurement of the prior hie usage behavior construct. our self-reported measure of usage was not as accurate, unbiased, or objective as usage data from system logs. we urge future researchers to use system log-based measures of it usage, if available. second, our small sample size, and correspondingly low statistical power, may have contributed to our inability to observe significant effects of prior usage behavior on each construct. we encourage future researchers to consider using larger samples, such as by using pooled observations from two or more hospitals and/or other healthcare facilities. third, there were participants that did not select either male or female gender. thus, the analysis of gender did not include the entire sample. finally, there may be additional factors beyond those examined in this study. our choice of the factors used here was motivated by the hie literature and a first round of interviews with providers. however, there may be other theories, such as innovation diffusion theory or political theory, that may also be relevant to explaining provider perceptions and behavior. future studies can explore those theories for identifying other predictors of provider behavior and/or compare the explanatory ability of those theories discussed herein. the findings of this study have interesting implications for health it practitioners. first, we provide evidence of the perspectives of various types of providers in terms of their beliefs and perceptions about hie. perceptions about system complexity, system concerns, patient care, population health, provider performance, and prior usage have varying effects in terms of influencing provider' perceptions about hie. however, implementing standards of care that incorporate hie is an instance of organizational change, requiring careful planning and orchestrating of change management to influence providers to routinely use the targeted technologies. change management programs designed to enhance provider intentions to use health it should focus on educating users on the expected performance gains from technology usage as well as improving their perceptions of behavioral control by training users to use those technologies appropriately. the significance of prior behavior on future hie usage intention is indicative of the importance of recruiting early adopters to "seed" hie usage in hospitals and healthcare settings. junior practitioners, by virtue of their more recent medical training involving the latest health it, may be viewed as more likely to be such early adopters. however, the results of this study also show that providers age to may provide a strong base of supporters. given their prior usage behavior and correspondingly, higher level of comfort with such technologies, these individuals are likely to continue using hie further in hospital settings, even when other conditions may be less conducive to their usage. with major health it policy efforts focused on interoperability, this study contributes to the perspective that different provider groups may be stronger facilitators of interoperability efforts than others and thus these findings could help managers and policymakers determine strategies for such efforts. this study examined provider perceptions about hie, comparing those who have not used hie with those who have previously used the technology. as such, the role of prior behavior on providers' perceptions and intentions regarding future hie usage provides new insights. one may hypothesize that if individuals use a system that is perceived to provide value, then use of that technology will proliferate and expand throughout the intended user population. findings indicate that this may not always be the case. as systems become more integrated, inter-organizational, and more complex, user perceived value derived from using that system may not be understood by the user. this study contributes to the nascent stage of theorizing in the medical informatics literature by presenting the theory of planned behavior as a referent theory that can not only help us understand providers' usage of hie better, but can also serve as a starting point for more detailed investigations of provider behavior. second, given that the centrality of hie usage to improving healthcare delivery, quality, and outcomes and the uphill battle many states and regions are currently facing to get providers to use hie, our study provides some preliminary suggestions about how providers' behaviors can be influenced using a strong evidence base. we also elaborate the contingent role played by prior hie usage experience in shaping providers' usage patterns. presumably, there may be more such contingent factors that may be the subject of future investigations. in conclusion, we hope that this study will motivate future researchers to examine in further depth provider hie usage behavior and contribute to a cumulative body of research in this area. publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. sue feldman, rn, med, phd is professor and director of graduate programs in health informatics in the school of health professions at the university of alabama at birmingham. dr. feldman is also a senior scientist in the informatics institute and senior fellow in the center for the study of community health. her research focuses on health information systemsfrom development to evaluation. dr. feldman also serves on the health informatics accreditation council for the commission on accreditation for health informatics and information management (cahiim), chairs graduate health informatics accreditation site visit teams, and has studied and developed graduate level health informatics curriculum. as a registered nurse (rn) for over years, she brings a unique clinical and informatics blend to everything she does, grounding policy and theory with practice. dr. feldman has published in a variety of top-tier peer-reviewed journals and conference proceedings, led or co-led the development of several information systems that are grounded in research, and has served as program chair for several national forums. her current work involves leading the development of a substance use, abuse, and recovery data collection system for the state of alabama as well as a statewide covid- symptom and exposure notification system. dr. feldman has a masters degree in education and a phd in education and also in information systems and technology from claremont graduate university. neşet hikmet is professor of health information technology in the college of engineering and computing, university of south carolina where he also serves as the director of applied sciences at center for applied innovation and advanced analytics. his research expertise includes cloud computing, augmented analytics, health informatics, and healthcare internet of things. as an applied scientist he is heavily involved in design, development, deployment, and maintenance of large-scale computing systems. dr. hikmet has significant experience in leading health data analytics projects within academia, including utilization of a wide range of analytics methods and approaches. his research and projects have been funded by the national science foundation, national institutes of health, and other federal and state agencies and private foundations. shikha modi, mba is a graduate of uab's mba program with an emphasis on healthcare services. ms. modi has a bachelor's degree in biology from university of north alabama. ms. modi's current research projects include health information technology and its impact on outcomes, health information exchange and provider performance, health information exchange and patient and population health, the intersection of health informatics, healthcare quality and safety, and healthcare simulation, patient experience evaluation at dermatology clinics, and identifying and mitigating bias in artificial intelligence systems. benjamin schooley, mba, phd is associate professor of health it in the college of engineering and computing, university of south carolina where he also serves as research director at the health information technology consortium. his research expertise includes human-computer interaction, health informatics, and human factors in the design and application of software systems. as a design scientist, his applied and field research in health, wellness and social-benefit initiatives have been funded by the national science foundation, national institutes of health, the centers for medicaid and medicare services, the u.s. department of labor, social security administration, and other federal and state agencies and private foundations. are individual differences germane to the acceptance of new information technologies? decision sciences does health information exchange reduce unnecessary neuroimaging and improve quality of headache care in the emergency department the triple aim: care, health, and cost health care 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financial impact of health information exchange on emergency department care the financial impact of health information exchange on emergency department care hospital electronic health information exchange grew substantially in - user perspectives on the usability of a regional health information exchange adoption of health information exchange by emergency physicians at three urban academic medical centers association between electronic medical record implementation and otolaryngologist productivity in the ambulatory setting information systems and healthcare xvi: physician adoption of electronic medical records: applying the utaut model in a healthcare context assessing the relationship between health information exchanges and public health agencies the impact of health information exchange on health outcomes examining the technology acceptance model using physician acceptance of telemedicine technology toward an understanding of the behavioral intention to use an information system a comprehensive conceptualization of post-adoptive behaviors associated with information technology enabled work systems health information exchange and patient safety diffusion of innovation theory physicians' perceptions and use of a health information exchange: a pilot program in south korea health information exchange in the ed: what do ed clinicians think? the effects of creating psychological ownership on physicians' acceptance of clinical information systems physicians' potential use and preferences related to health information exchange despite the spread of health information exchange, there is little evidence of its impact on cost, use, and quality of care crossing the quality chasm: a new health system for the st century health information exchange in small-to-medium sized family medicine practices: motivators, barriers, and potential facilitators of adoption effects of health information exchange adoption on ambulatory testing rates what affects clinicians' usage of health information exchange usage and effect of health information exchange: a systematic review health information exchange interventions can enhance quality and continuity of hiv care using health information exchange to improve public health assessing it usage: the role of prior experience understanding information technology usage: a test of competing models influence of experience on personal computer utilization: testing a conceptual model interpersonal behavior comparing individual means in the analysis of variance bridging organizational divides in healthcare: an ecological view of health information exchange perceptions of health information exchange in home healthcare the association between health information exchange and measures of patient satisfaction factors motivating and affecting health information exchange usage an empirical analysis of the financial benefits of health information exchange in emergency departments identifying homelessness using health information exchange data key: cord- -fkddo n authors: griffin, brenda title: population wellness: keeping cats physically and behaviorally healthy date: - - journal: the cat doi: . /b - - - - . - sha: doc_id: cord_uid: fkddo n nan o u t l i n e whereas feline practitioners are usually well versed in the creation of wellness programs tailored to individual cats, optimizing the health of a population of cats requires additional knowledge and poses unique challenges. these challenges will vary depending on many factors, including the nature and purpose of the population itself. indeed, veterinarians may be tasked with developing health care programs for cat populations in a wide spectrum of settings-from facilities housing laboratory animals, to animal shelters, home-based rescue and foster providers, care-for-life cat sanctuaries, breeding catteries, or large multicat households. regardless of the setting, a systematic approach to the health of the clowder is crucial for success. merriam-webster's dictionary defines wellness as "the quality or state of being in good health especially as an actively sought goal." ensuring population health requires careful planning and active implementation of comprehensive wellness protocols that address both animal health and environmental conditions ( figure - ). addressing physical health alone is not sufficient to ensure wellness. for example, a cat may be in proper physical condition and free from infectious or other physical disease, yet suffering from severe stress and anxiety. in this case, the patient cannot be assessed as healthy, because its behavioral (emotional) state is compromising its health and well-being. thus physical health and behavioral health are both essential components of wellness, and preventive health care must actively address each of these. addressing the environment of the population is also critically important when considering wellness. even the best-designed facilities cannot favor good health in a multicat environment without thoughtful implementation of environmental wellness protocols. in small animal practice, environmental wellness is frequently not emphasized simply because many owners are accustomed to providing a reasonably healthy environment for their pets. in contrast, a structured program to address environmental wellness is essential in the more specific goals will vary depending upon the given population and its purpose. for example, in an animal shelter, specific goals of the wellness program might include decreasing the incidence and prevalence of infectious diseases in the shelter and following adoption, decreasing the incidence of problem behaviors in the shelter, decreasing the rate of return of cats to the shelter for problem behaviors, increasing the adoption rate, and so forth. in the context of a breeding colony, the goals might include increasing kitten birth weights, decreasing neonatal mortality, or improving socialization of kittens. by identifying and tracking measurable factors (often called performance targets in large animal medicine), it is possible to measure progress toward these goals. once baseline data (such as disease rates) are established, it is possible to measure the impact of protocol changes on population health by evaluating these performance targets. both medical records and a system for regular surveillance and reporting are required to accurately track and access trends in animal health. early recognition is crucial for effective control of infectious disease and problem behavior in a group. therefore a regular system of health surveillance must be in place to monitor every individual. in a population setting, daily "walk-through rounds" represent the foundation of an effective animal health care program. rounds should be conducted at least once daily (preferably twice a day or more often, depending upon the needs of individual cats) for the purpose of monitoring and evaluating both physical and behavioral health. medically trained caregivers should visually observe every animal and its environment, taking note of food and water consumption, urination, defecation, attitude, behavior, ambulation, and signs of illness, pain or other problems. monitoring should take place before cleaning so that food intake and the condition of the enclosure, including the presence of feces, urine, or vomit can be noted. alternatively, observation logs can be completed by caregivers at the time of cleaning and reviewed during walk-though rounds. any cat that is observed to be experiencing a problem, whether it be signs of respiratory infection, diarrhea, anxiety, or obvious pain, suffering, or distress must be assessed and treated in a timely manner. regardless of length of stay, regular daily assessment is imperative to identify new problems (medical or behavioral) that may develop so that they can be identified and addressed in a timely fashion to ensure the welfare of the individual animal as well as that of the population. context of a population, regardless of the actual physical facility. proactive measures to maintain clean, sanitary environments that are not overcrowded-where cats are segregated by age and health status and provided with regular daily schedules of care by well-trained dedicated caregivers-are essential. simply stated, the overarching goals of a population wellness program are to optimize both the physical and behavioral health of the cats as well as preventing transmission of zoonotic diseases. in other words, a population wellness program should be designed to keep animals "healthy and happy" while keeping human caregivers safe. it is not difficult to identify a healthy population of cats: when wellness protocols are successful, cats "look healthy" and "act like normal cats." in other words, they appear in good physical condition and display a wide variety of normal feline behaviors, including eating, stretching, grooming, scratching, playing, rubbing, resting, and if allowed, courtship and breeding. just as changes in a cat's physical appearance should alert the clinician to potential problems, so should the absence of such normal feline activities and behaviors by members of the group. wellness goals must include maintaining the health of individual animals as well as that of the population as a whole. in the context of the population, the individuals that are physically or behaviorally ill serve as indicators or "barometers" of the health care and conditions of the population. when individuals are ill, their health and well-being is always a priority; however, it should also immediately trigger the clinician to ask, "why is this individual sick? what is the cause of its illness, and how can i prevent this from affecting others?" to optimize feline health, wellness programs must be carefully structured to address both the physical and behavioral health of the animals, which are intimately linked to their environment, making it crucial to systematically address environmental conditions as well. behavioral health . freedom from thirst, hunger, and malnutrition by providing ready access to fresh water and a diet that maintains full health and vigor . freedom from discomfort by providing a suitable environment, including shelter and a comfortable resting area . freedom from pain, injury, and disease by prevention or rapid diagnosis and treatment . freedom to express normal behavior by providing sufficient space, proper facilities, and company of the animals' own kind . freedom from fear and distress by ensuring conditions that avoid mental suffering in addition to early recognition of health problems, timely action is crucial to effectively limit their morbidity. ideally, all facilities that house multiple cats should have written policies and protocols in place that detail how medical and behavioral problems will be handled. , , a committee or team of individuals composed of medical staff, managers, and caregivers can establish and oversee these policies and protocols. such protocols serve as guidelines for systematic triage and care of animals and help to prevent delays in care that may otherwise arise if such plans were not in place. policies and protocols should be based on medical facts, taking into account the entity's purpose or mission and the availability of resources for care. they should include a definition or description of the disease or condition in question, a description of the methods that will be used for diagnosis, and a general policy regarding the handling and disposition of affected cats. in addition, protocols should include details on notification, housing, decontamination, treatment, and documentation (box - ). just as quality-of-life assessment is the responsibility of every veterinarian as they guide the medical care of individual animals, quality-of-life assessment is also a critical part of population health care and monitoring. the factors that affect physical and mental well-being are broad, complex, and often vary substantially among individuals. exacting criteria are lacking for the objective measurement of quality of life of cats. however, subjective assessments can and should be made by medical and behavioral personnel at regular intervals (weekly or even daily, as indicated) considering the most information possible. , the "five freedoms," which were originally described by the farm animal welfare council in the s, represent a benchmark for ensuring quality of life or animal welfare (box - ). these principles provide a useful framework that is applicable across varying situations and species and have been widely accepted and endorsed by animal care experts. many agencies have used the five freedoms as the basis of recommendations for minimum standards of care for many species, including cats housed in catteries, shelters, and research facilities. , , , the tenets of the five freedoms define essential outcomes and imply criteria for assessment but do not prescribe the methods by which to achieve those outcomes. regardless of the setting, population wellness programs should ensure the five freedoms for all cats. wellness always starts with prevention: it is far more time and cost efficient than treatment, and it is kinder to the animals and their caregivers. with this in mind, population wellness programs should provide broad-based, holistic approaches to preventive care, rather than being based on the control of a single disease or problem, regardless of the setting. maintenance of good health or wellness is especially challenging in populations with high turnover and interchange of cats of varying ages and susceptibilities, such as animal shelters. infectious diseases can become endemic in facilities where populations of animals are housed. even in closed populations, certain pathogens can be difficult to exclude or to eliminate once introduced. notably, upper respiratory viruses, dermatophytes, and coccidia are among the most difficult pathogenic agents to control because of their persistence in the environment through carrier states and/or resistance to environmental disinfection. in particular, upper respiratory disease is the most common endemic disease in cat populations and is impossible to completely prevent in an open population. feline herpes virus type (fhv- ) and feline calicivirus (fcv) have been implicated as the causes of most infections: both viruses induce persistent carrier states and are widespread in the cat population. cats that recover from fhv- remain latently infected and shed virus intermittently, especially following periods of stress. fcv carriers shed continuously for months to years following infection. a variety of other viral and bacterial pathogens may also contribute to feline upper respiratory disease, and bordetella, chlamydophila, and mycoplasma are problematic in some populations. feline infectious peritonitis (fip) is another disease that is nearly impossible to eradicate from a multicat environment, and sporadic cases can be expected to occur, especially in young cats. fortunately, proper wellness programs can greatly limit the incidence and severity of diseases, even for pathogens that are difficult to control. the multicat environment also presents enormous opportunities for inducing stress. because of their unique biology, cats are particularly prone to experiencing acute stress and fear in novel environments. anything unfamiliar to a cat can trigger apprehension, activating the stress response. confinement in a novel environment can result in a wide variety of behavioral indicators of stress including hypervigilance, feigned sleep, constant hiding, activity depression, and loss of appetite, among others. in the long term, if cats are unable to acclimate or cope in their environments, chronic stress, fear, frustration, or learned helplessness may result. in group settings, signs of social stress may also manifest with medical decisions must be weighed in the context of the health of the population as well that of the individual, while considering animal welfare and the availability of resources for care. when large numbers of animals are involved, situations may arise in which animal health and welfare cannot be managed in the case of every individual animal. this may be due to physical or behavioral illness, or environmental conditions that negatively impact animal health, such as crowding. regardless of the cause, it may be necessary to euthanize affected individuals if no other remedies exist to relieve animal suffering or to protect population health. these decisions can be difficult and emotionally challenging, especially in instances where the individual could easily be treated or otherwise accommodated if adequate resources were available. however, such decisions may be crucial for disease control, animal welfare, and population health. that being said, euthanasia should never be used as a substitute for providing proper husbandry and care. indeed, a critical need for a comprehensive wellness program exists in every multicat setting. it is unacceptable to house animals under conditions likely to induce illness and poor welfare, and such conditions can be expected when wellness programs are not in place and carefully monitored. when facilities elect to house cats with medical or behavioral problems, appropriate veterinary care must be provided. it is imperative that a humane plan for diagnosis, treatment/management, monitoring, and housing be implemented in a timely fashion. when determining if cats with special needs can be humanely cared for in a population setting, the following goals and considerations should be addressed: what measures must be implemented to prevent transmission of disease to other cats or people? can appropriate care realistically be delivered? will the care provided result in a cure or adequate management of the disease or problem behavior? can the facility afford the cost and time for care? how will it impact resources available for other cats? in the case of animal shelters, additional considerations should include will the cat be adoptable? what steps can be taken to minimize the holding time required for treatment? if the cat is not adopted, do humane long-term care options exist in the shelter? what welfare assessment will be used to measure quality of life in the shelter? disease control efforts when disease is present. however, the best method of disease control is always prevention. when creating preventive medicine programs for a population, consideration must be given to all components of wellness: physical, behavioral, and environmental health. with regard to promoting physical health, wellness programs should address the following essential elements: implementing population wellness protocols and ensuring quality and timely care require reliable systems for medical record keeping and animal identification. regardless of the system used, medical record keeping procedures should comply with state and local practice acts, guidelines provided by state and national veterinary medical associations, and, in the case of laboratory animals, regulations as prescribed by federal law, the increases in problem behaviors, including urine marking, spraying, or other inappropriate elimination; constant hiding; and/or aggression. stress not only has the potential to negatively impact behavioral health but also physical health as well. the intimate link between stress and immunity has been well described. in fact, stress is a leading factor in the development of infectious disease and is particularly important in the pathogenesis of feline upper respiratory infections. , wellness programs that reduce stress will also serve to minimize the morbidity of infectious disease. despite the fact that infectious agents can never be completely eliminated from the environment, it is still possible to maintain good health. this is because the development of disease is determined by a complex interaction of many factors surrounding the host, the infectious agent, and the environment. keeping these factors in mind provides a rational context for many of the recommendations in this chapter. some of the host factors that influence health and the development of disease include age, sex and reproductive status, immune status, body condition, stress, and genetics. the amount and duration of exposure to an infectious agent (i.e., the "dose effect"), as well as its virulence and route of inoculation, also influence the likelihood and severity of disease. in addition, environmental conditions contribute to the development of infectious disease, including such factors as housing density, sanitation, and fluctuations in temperature or air quality. the fact that disease results from such a large combination of factors underscores the importance of a holistic and broad-based approach to population wellness. when infectious disease does occur in a population, general principles of infectious disease control should guide the response. these include . some facilities prefer to use safety collars that are designed to break away should the collar become caught on something. even for kittens, collars can be used and may be especially beneficial, because they will learn to wear them from an early age. microchips may also be used for identification and are safe and simple to implant (figure - ) . the procedure is well tolerated by the vast majority of cats without the need for sedation. unlike visual means of identification, a scanner is necessary for positive identification of a microchipped animal. for this reason, microchips are often used in conjunction with a visual means of identification and serve as important permanent means of backup identification. box - describes the proper technique for scanning for a microchip. during the last decades, microchips of varying radiofrequencies ( , , and khz) have been introduced in the united states. the -khz chips have historically been the most common, whereas the accepted standard in the rest of the world is the -khz chip. because some scanners read only certain radiofrequencies, it is possible to miss detecting a microchip that is present, depending on the scanner being used. currently, there are efforts to standardize microchipping in the united states, including widespread distribution of universal (global) scanners to ensure that all implanted microchips can be reliably identified. once global scanners are widely available, the american veterinary medical association (avma) recommends adoption of the -khz (iso) microchip as the american standard, because this frequency is recognized as the international standard for microchips institute for laboratory animal research and institutional animal care and use committees. computerized records are preferred; however, written records may also be used. computerized records offer the advantage of mechanized reporting, which facilitates detection and monitoring of health trends in the population. a medical record should be prepared for each cat and should include the cat's entry date, identification (id) number, date of birth, gender, breed, and physical description, as well as historical and physical/behavioral examination findings. in addition, it should contain the dosages of all drugs administered and their routes of administration, including vaccines, parasite control products, other treatments, and anesthetic agents; the results of any diagnostic tests performed; any surgical procedure(s) performed; and other pertinent information regarding the animal's condition. standardized examination and operative reports may be used, but should allow for additions when necessary. identification of cats in the form of a neckband, collar and tag, tattoo, earband, and/or a microchip is also essential for preventive health care and ongoing surveillance of individuals. whenever possible, some form of identification should be physically affixed to every individual cat. in addition, enclosures should be labeled with the cats' unique identification number and/or name. contrary to popular belief, most cats can reliably wear collars safely and comfortably. many facilities use disposable collars, including commercially available plastic or paper neckbands made for animals or hospital-type wristbands made for human patients (figure - ). commercially available cat collars with an id tag affixed in the rest of the world. efforts have also focused on improving, updating, and centralizing microchip registries. this is extremely important in the context of animal shelters. box - contains information on the use of collars and microchips as tools for improving cat-owner reunification. in laboratory settings, tattoos may be used as a means of permanent identification of cats ( figure - ). tattoos are most commonly applied to the inner pinna of the ear using a tattoo machine with multiple needles. care must be taken to properly disinfect the needles between patients. a significant disadvantage of tattooing is that tattoos can sometimes be difficult to read because of the presence of hair, fading, or distortion that may occur as the cat grows. in addition, their application requires anesthesia or heavy sedation. small stainless steel ear tags manufactured for wing banding of birds are especially useful for identifying newborn kittens in some settings and are highly economical (figure - ). they can be placed without the need for anesthesia or sedation when kittens are less than to days old. placing earbands requires skill and experience. they must be positioned in such a way as to provide adequate space for growth of the ear, while seating them deeply enough in the ear margin to ensure a secure piercing far enough away from the edge. if placed too close to the ear margin, the ear flap may tear, resulting in loss of the band. other complications include local inflammation or infection at the site of the piercing. ear tags are a practical method for identifying individual kittens in institutional or commercial breeding colonies, because when applied skillfully, they are seldom lost and provide reliable, long-lasting visual identification. in contrast, private breeding catteries and animal shelters generally prefer to use methods that will not alter the cat's cosmetic appearance long term. colored ribbon, nail polish, or clipping of hair in various areas of the body can all be useful means of temporary kitten identification in the neonatal stage, especially when coat color or patterns do not easily allow individuals to be distinguished. every cat, including those surrendered by their owners, should be systematically scanned for the presence of a microchip at the time of intake, as well as prior to being made available for adoption or being euthanized. proper technique and scanning more than once are crucial to avoid missing microchips. , a universal (global) scanner (e.g., one that will read all microchip frequencies that are currently in use) should be used to ensure that all microchip frequencies are detected. at this time, the only universal scanners available in the united states are the new home again global world scanner (schering plough, whitehouse station, ny) and the imax black label resq scanner (bayer animal health, shawnee mission, kans.). one of the most common causes of scanner failure is weak batteries; therefore it is imperative that batteries be checked and replaced regularly. to ensure a thorough scan and avoid missing chips, cats must be removed from carriers or cages prior to scanning. metal and fluorescent lighting may interfere with chip detection. metal exam surfaces should be covered with a towel or other material prior to scanning to minimize interference. the entire animal should be scanned using a consistent speed, scanner orientation, scanning pattern, and distance. • scanner orientation: the scanner should be held parallel to the animal. rocking the scanner slightly from side to side will maximize the potential for optimal chip orientation and successful detection. the button on the scanner should be depressed continuously during the entire scanning procedure. • scanning distance: the scanner should be held in contact with the animal during scanning such that it is lightly touching the hair coat. • scanner speed: the scanner should not be advanced any faster than . m/second ( . ft/second). scanning slowly is crucial, because universal scanners must cycle through various modes to read all possible chip frequencies. • areas of animal to scan: the standard implant site is midway between the shoulder blades, and scanning should begin over this area. if a microchip is not detected here, scanning should proceed systematically down the back, on the sides, neck, and shoulders-all the way to the elbows in the front and the hindquarters in the rear. • scanning pattern: the scanner should be moved over the scanning areas in an "s"-shaped pattern in a transverse direction (from side to side). if no microchip is detected, the scanner should be rotated degrees, and then the "s"-shaped pattern should be repeated in a longitudinal direction (e.g., the long way) on both sides of the animal. this pattern of scanning will maximize the ability of the scanner to detect the microchip, regardless of its orientation. • less than % of cats are reunited with their owners, compared to as many as % to % of lost dogs. • the use of collars and tags as visually obvious forms of identification is extremely valuable, although overlooked by many cat owners. • cats wearing collars are more likely to be identified as owned and not mistaken for strays. • even indoor cats require identification in case they escape, and studies clearly demonstrate that visual identification improves the odds of pet-owner reunification. • the provision of permanent identification in the form of a microchip represents an important backup, further improving the odds of pet-owner reunification because collars and tags can be lost. • because owners and shelter staff often describe cat coat color and patterns differently, photographs that can be posted online are a useful method of improving lost-pet matching and enabling owners to look for their pet, even if they are physically unable to come to the shelter. • adopted animals should be sent home with id collars and microchips. • shelter staff should always register microchips before the cat leaves the shelter, because many owners will neglect to do so following adoption, making the microchip an ineffective means of identification. • web-based search engines for pet microchip identification numbers (http://www.checkthechip.com and http://www.petmicrochiplookup.org) have been established in an effort to functionally centralize microchip registries by linking existing national databases. facility that houses cats establish a formal relationship with one or more veterinarians who have direct knowledge of their animal population. this is essential to ensure that medical protocols are established with the proper professional oversight, and helps to ensure compliance with local veterinary practice acts that restrict the practice of veterinary medicine to licensed veterinarians. in facilities such as animal shelters, trained shelter staff can carry out preventive health care under the instructions of a veterinarian. the success or failure of a population wellness program hinges in large part on its implementation and oversight. a knowledgeable, cohesive, and dedicated team, where accountability, responsibility, and lines of authority are well defined, is crucial for management success. as a part of the management structure and plan, veterinarians must be involved in the oversight of all aspects of animal care and must be given direct authority for the oversight of medical decisions. this requires that every physical examination is the clinician's single most important tool for evaluating health. following a standardized physical examination form will ensure a complete and systematic review of all body systems. a veterinarian should carefully examine any new cat entering a closed population prior to admittance. in the context of animal shelters, every cat that is safe to handle should receive a physical examination at or as close to the time of admission to the shelter as possible. in many shelters, a veterinarian may not be available to examine incoming animals. however, staff can and should be trained to perform basic evaluations including sexing, aging, body condition scoring, and looking for evidence of fleas, ear mites, dental disease, overgrown claws, advanced pregnancy, or other obvious physical conditions. of particular importance in the shelter physical examination are an accurate physical description of the animal and careful inspection for the presence of identification, both of which may aid in pet-owner reunification. the gold standard for maintaining the health of a population is through exclusion of pathogens in combination with implementation of comprehensive wellness protocols. this requires that members of a population be free from specific pathogens when the group is established and that the colony be closed to any new individuals that do not meet the health standards of the group. this is the foundation of disease control procedures in a laboratory animal setting, and these concepts should be applied to other population settings whenever possible. consideration should be given to testing for the following: feline leukemia virus (felv), feline immunodeficiency virus (fiv), dermatophytosis, intestinal parasites and infections (e.g., campylobacter, giardia, coccidia), as well as other endoparasites and ectoparasites. the setting and resources available, as well as the individual's history and physical examination findings, should guide the clinician's decisions regarding selection of testing for cats entering a specific population. when new stock is added to a closed colony, disease testing is imperative. the american association of feline practitioners (aafp) maintains detailed professional guidelines for the management of felv and fiv infections. identification and exclusion of infected cats is the most effective method of preventing new infections. cats and kittens should always be tested prior to entry to a closed population. those that test negative should be retested, because it the clinician should develop a program for physical health for the population that addresses all of the essential elements as noted. none of these should be considered as optional, but their implementation will depend on the setting, purposes, and resources of the group. the value of obtaining an accurate medical history on any cat entering a population is immeasurable, because it will often alert the clinician to the presence of potential problems. in a laboratory setting, obtaining cats from commercial purpose-bred colonies or institutional breeding colonies ensures that an accurate history will be available, maximizing the odds that only healthy cats will be added to the population. likewise, private breeding catteries should always strive to obtain an accurate medical history on any cat that may be accepted into the cattery. the introduction of cats from random sources to closed populations of cats risks the health of the population and should be avoided whenever possible. in contrast, by their very nature, animal shelters must frequently receive cats from multiple random sources, and it will not always be possible to obtain accurate histories. in some cases, cats are brought in by animal control officers or good samaritans who have little if any information about them. furthermore, some shelters provide a location (e.g., drop-off cages) where cats can be relinquished after business hours. this practice should be discouraged; however, if facilities elect to do this, every effort must be made to obtain a history through questionnaires that can be completed when the cat is left. the presence of staff to directly accept cats and obtain a history at the time of relinquishment is greatly preferred. even so, surrendering owners may or may not provide complete or accurate information, fearing that if they are honest about a pet's problems, the pet may be euthanized. nonetheless, when available, a history can be extremely valuable, saving time and money as well as preventing unnecessary stress for cats and staff alike. intake procedures should be in place to capture basic patient information, including both physical and behavioral data as well as the reason(s) for relinquishment. the importance of obtaining historical information cannot be overemphasized. in many cases, historical information may be used to expedite the disposition of the cat in the shelter. can be problematic. in relation to population health, testing is of little value, because infected cats pose no risk to other cats. nonetheless, a clinician may elect testing as part of an initial database for individual cats, especially if they will be used for breeding. with heartworm tests readily available in combination with pointof-care felv/fiv tests, many animal shelters have been faced with determining whether or not to perform routine screening of cats in their care. to answer this question, it is helpful to consider the following: in consideration of these facts, the author does not recommend routine screening of cats for heartworm disease in shelters. monthly chemoprophylaxis, however, is a safe and effective option for cats sheltered in areas where heartworm infection is considered endemic. dermatophytosis or ringworm, the most common skin infection of cats, is a known zoonosis. it is caused by infection of the skin, hair, and nails with microscopic fungal organisms that cause varying degrees of hair loss and dermatitis. the dermatophyte that causes the majority of cases in felines is microsporum canis, which is responsible for greater than % of all cases. if left untreated, most infections will spontaneously resolve within to weeks postinfection. however, during this time, the infected cat will infect the surrounding environment and other animals or humans in the area. not all cats infected with dermatophytosis develop lesions, and some may become chronic carriers. control of dermatophytosis is difficult, because the spores formed by m. canis can survive in the environment for up to months or longer and are extremely resistant to disinfectants and detergents. in addition, the presence of asymptomatic carriers makes it difficult to readily recognize all infected cats. for this reason, consideration should be given to culturing all cats prior to entry to a closed colony. in particular, persian cats may be predisposed to dermatophyte infection and can be particularly difficult to clear once infected. in closed colony settings, dermatophyte testing by culture is highly recommended unless the source of the cat excludes the possibility of infection (e.g., specific pathogen-free [spf] cats, purposebred laboratory cats). to screen cats using cultures, may take as long as days following exposure for a cat to test positive. , in the context of animal shelters, testing decisions are often influenced by the availability of resources. the aafp's guidelines include recommendations specifically for shelters. they state that all cats should ideally be tested at the time of entry and again in days in case of recent exposure. when cats test positive on screening tests (e.g., point-of-care enzyme-linked immunosorbent assay [elisa] tests), the aafp recommends that the results be confirmed by additional testing, including testing over an interval of time, because false positives can occur. however, such confirmatory testing requires substantial time and monetary investment and may not be feasible in many shelters. in recognition of this, the association of shelter veterinarians established a policy statement on "management of cats who test positive for felv and fiv in an animal shelter," which states that the logistics and cost of holding and retesting unowned cats may be an ineffective use of resources. in addition, it can be difficult to find homes for retroviruspositive cats, which in many instances translates into stressful, prolonged shelter stays. such long-term confinement may compromise quality of life and may compound the emotional stress of caregivers who may later be faced with euthanizing cats that have been held for long periods awaiting confirmatory testing or adoption opportunities. for all of these reasons, many shelters elect to euthanize cats that test positive on retrovirus screening tests. although it may be ideal for shelters to test cats on entry, it is not always feasible because of financial constraints. the next best practice might be to test cats prior to adoption as well as those that are housed in the shelter long term. in addition, cats should be tested prior to placement in group housing with unfamiliar cats and prior to investment, such as foster care, treatment, or spay/neuter surgery. however, given the limited resources of many shelters, the relatively low prevalence in healthy cats and the fact that transmission can be prevented by housing cats separately, it may not be cost effective for all shelters to screen every cat before selection for adoption. each shelter should evaluate its own resources and determine their best use. when testing is performed, samples must never be pooled, and the negative results of one cat (such as a mother cat) should not be extrapolated to other cats (such as her kittens). these practices are invalid and can falsely lead to misidentification of a cat's true infection status. , if testing is not performed prior to adoption, adopters should be advised to have their new pet tested and to keep them separate from any other cats they may own prior to doing so. point-of-care heartworm tests for cats have recently become more widely available, but interpreting results vaccination protocols are typically applied uniformly to all of the individuals comprising the population. this simplifies their application and helps to afford the best possible protection for the group. detailed vaccination records should be maintained for each cat, including vaccine name, manufacturer and serial number, date, the initials of the person who administered it, and any adverse reactions. proper vaccination can substantially reduce disease in cat populations, and serious adverse reactions are relatively rare. for this reason, vaccination against certain core diseases is recommended in all population settings. although exclusion of infectious disease is always a goal of health management, certain pathogens are so widespread that even with careful biosecurity in a closed population, an infection may be introduced to susceptible cats. only in the case of specific pathogen-free colonies, where there may be a compelling reason not to vaccinate as dictated by the purposes of the research, should vaccination be foregone. the aafp maintains published guidelines for vaccination of cats in a variety of settings and includes detailed recommendations for cats in animal shelters. although many vaccines are commercially available for cats, only a few are recommended for routine use in populations. unnecessary use of vaccines should be avoided to minimize the incidence of adverse reactions and reduce cost. core vaccines involve diseases that represent significant morbidity and mortality and for which vaccination has been demonstrated to provide relatively good protection against disease. core vaccines for cats in a population setting include feline parvovirus (fpv or panleukopenia), fhv- (feline herpes virus type or feline rhinotracheitis virus), and feline calicivirus (fcv). these vaccines are usually given in a combination product commonly referred to as an fvrcp vaccine (feline viral rhinotracheitis, calicivirus, panleukopenia). in most cases, timely vaccination against panleukopenia will prevent the development of clinical disease. in contrast, vaccination against the respiratory viruses (fhv- and fcv) does not always prevent disease. in many instances, it affords only partial protection, lessening the severity of clinical signs but not preventing infection. to optimize response, modified live vaccines (mlv) should be used in most cases, because they evoke a more rapid and robust immune response and are better at overcoming maternal antibody interference than killed products. this is especially important in multicat environments in which the risk of infection is high, such as animal shelters, foster homes, as well as any population setting where upper respiratory disease is endemic. a samples should be collected using the mckenzie toothbrush method, where a new toothbrush is used to brush the cat's entire body, giving special attention to the face, ears, and limbs. in addition, if skin lesions are present, hair should be plucked around these areas for culture as well. campylobacter, salmonella, giardia, coccidia, tritrichomonas, and other gastrointestinal parasites and pathogens are common in some cattery situations and can be very difficult to eliminate once they are introduced. in fact, in some settings, these pathogens may become endemic and nearly impossible to eliminate. treatment of coccidia in shelter kittens is described in although clinical signs, such as diarrhea, may be associated with infection, some cats remain asymptomatic. these pathogens have the potential for high morbidity in a population (especially in young kittens), and some possess zoonotic potential. therefore routine fecal examinations, cultures, and/or empirical treatments should be considered prior to the introduction of new cats. it is well recognized that vaccination plays a vital role in the prevention and control of infectious diseases. protocols should be established in the context of the population's exposure risk, which will vary depending upon the setting. in the context of population medicine, ponazuril is a metabolite of toltrazuril that has proven activity against coccidia.* because there is no approved product for use in cats, the equine product marquis oral paste ( % w/w ponazuril; bayer healthcare) may be dosed at mg/kg, po, once daily for to days. prophylactic treatment may be instituted in high-risk situations, such as young kittens in environments with documented infection. proper hygiene, including the use of disposable litter boxes and frequent removal of feces, is also necessary. oocysts survive in the environment and are not treated by routine disinfectants, such as bleach and quaternary ammonium compounds. with a history of upper respiratory infection) may benefit from vaccination prior to breeding to maximize passage of maternal antibody to their kittens. for pregnant cats in such environments, administration of mlv should be avoided, because the potential risk of injury to the developing kittens may outweigh the risk of infection in this case. vaccination of lactating queens should also be avoided in a low-risk environment. a series of vaccinations should be administered to kittens less than months of age to minimize the window of susceptibility to infection and ensure that a vaccine is received as soon as possible after maternal antibodies have decreased sufficiently to allow vaccine response. for kittens, vaccines should be administered every to weeks until they are weeks (e.g., months) of age or their permanent incisors have erupted. the minimum interval of weeks is recommended in high-risk settings to narrow the window of susceptibility as maternal antibody wanes. a vaccination interval of less than weeks is not recommended, because it may actually blunt the immune response from previous vaccination. in the case of an outbreak of panleukopenia, extending vaccination to months of age may be warranted to ensure than no animal remains susceptible. although the vast majority will respond by months of age, a few may fail to respond, while others are provided with a boost to enhance the immune response. just as in owned pets, booster vaccines are generally not required until year later for modified live vaccines but should ideally be administered once in to weeks whenever resources permit. this may be especially important for cats that were ill at the time of initial vaccination, as may be the case in an animal shelter. revaccination in long-term shelter facilities should follow the guidelines set forth for pets: boost at one year, then every years for fvrcp. vaccination against rabies virus is regarded as a core requirement for pet cats and is required by law in some jurisdictions. thus vaccination against rabies is recommended in the context of private catteries. in contrast, rabies vaccination may be considered optional in most closed laboratory settings, because the risk of exposure should be absent and legal requirements may not apply. in animal shelters, vaccination against rabies is not generally recommended at the time of admission, simply because there is no benefit in terms of disease prevention or public health. vaccination on admission will not provide protection against an infection acquired prior to entry, nor will it limit concern if a cat with an unknown health history bites someone soon after admission. rabies vaccination is recommended for cats prior to adoption when a veterinarian is available to administer it (or as otherwise legally prescribed by state laws). alternatively, rabies vaccination may be administered as single modified live fvrcp vaccine will usually afford protection to cats that are at least months of age. in contrast, killed products require a booster in to weeks to confer immunity, making their use largely ineffective in such environments. to ensure rapid protection against panleukopenia, injectable fvrcp vaccines are preferred, but intranasal vaccines may offer advantages for feline respiratory disease, because they have been shown to rapidly induce local immunity at the site of exposure. furthermore, intranasal vaccines may be better at overriding maternal antibody in young kittens. for this reason, they are often used to reduce the morbidity and severity of upper respiratory infection (uri) in preweaningage kittens. when intranasal vaccines are used in animal shelters, they should be used in combination with injectable fvrcp vaccines to ensure and optimize response against panleukopenia as well as the respiratory infections. ideally, all cats should receive a mlv fvrcp vaccine at least week prior to entering a population. in the context of an animal shelter setting, this is seldom feasible. vaccination immediately upon entry is the next best practice and can provide clinically significant protection for the majority of cats. if neither maternal antibody nor another cause of vaccine failure interferes, modified live vaccinations against panleukopenia will often confer protection against disease in only days. intranasal vaccines against respiratory infections, including fhv and fcv, typically provide partial protection within to days. , in animal shelters, all incoming cats and kittens weeks of age and older that can be safely handled should receive an injectable mlv fvrcp vaccine immediately upon entry. a delay of even a day or two significantly compromises the vaccine's ability to provide timely protection. even injured cats, those with medical conditions, and those that are pregnant or lactating should be vaccinated on entry, because vaccination will likely be effective and the small risk of adverse effects is outweighed by the high risk of disease exposure and infection in the shelter. when vaccination of all cats on entry is not financially feasible, the next best practice is to vaccinate all those that are deemed adoptable at the time of entry or that are likely to be in the shelter long term. whenever possible, vaccinated cats should be separated from those that will remain unvaccinated (e.g., those that will be euthanized following a brief holding period) as soon as that determination can be made. in contrast, in lower-risk settings, ensuring that cats are in good health prior to vaccination should be a priority. vaccination of kittens with injectable fvrcp vaccinations may be delayed to to weeks of age. however, when respiratory disease is endemic, administration of intranasal vaccines beginning at weeks of age may be beneficial. in breeding catteries, queens (especially those control and prevention of internal and external parasites represent another important component of a population wellness program. common products used for their management are described elsewhere in this book. of particular importance are roundworms and hookworms, common intestinal parasites with zoonotic potential (see chapter ) . although uncommon, the risk of human infection from contaminated environments is real and can result in organ damage, blindness, and skin infections. for this reason, the centers for disease control and prevention and the companion animal parasite council strongly advise routine administration of broad-spectrum anthelminthics for their control. , pyrantel pamoate is one of the most costeffective and efficacious drugs for treatment and control of roundworms and hookworms. in both shelter and cattery settings, the author recommends administration of pyrantel pamoate at a dosage of mg/kg to all cats with re-treatment in weeks and then at monthly intervals. in shelters, if it is not possible to treat all cats at the time of entry, at a minimum, all cats that are deemed adoptable should be treated as soon as possible. in addition, kittens should be treated at -week intervals until months of age. for cats with diarrhea, fecal examination (e.g., flotation or centrifugation, direct fecal smear and cytology) should be performed with treatment according to results. even if results are negative, the administration of broad-spectrum anthelminthics should be strongly considered. in animal shelters, ectoparasites, particularly ear mites and fleas, are also very common in cats and kittens. shelter staff should be trained to recognize infestation and protocols should be established for treatment. in terms of shelter treatment protocols, the author recommends treating ear mites with ivermectin, because it is highly efficacious and costs only pennies per dose. the recommended dosage is . mg/kg subcutaneously. for fleas, the author recommends topical treatment with fipronil (frontline, merial, duluth, ga.) as a spray or top spot. in particular, the spray is very cost effective. it is safe for use in cats of all ages, including pregnant and nursing mothers and neonatal kittens. in addition, fipronil also has activity against ear mites, cheyetiella, chewing lice, and ticks. , spaying and neutering is another important consideration in the context of population wellness. reproductive stress from estrous cycling in queens and sex drive in tomcats can decrease appetite, increase urine spraying/ marking and intermale fighting, and profoundly increase social and emotional stress in the group. for these reasons, spaying and neutering cats that will not be used soon as possible following adoption. the latter may encourage new owners to establish a relationship with a private veterinarian. rabies vaccination is warranted when cats are housed long term in shelter facilities. in addition, if individual cats must be held for bite quarantines, they should be vaccinated against rabies in accordance with the current compendium of animal rabies prevention and control. noncore vaccines include those that may offer protection against disease, but because the disease in question is not widespread or only poses a risk of exposure in certain circumstances, vaccination is only recommended based on the individual risk assessment of a population of animals. noncore vaccines include felv, fiv, chlamydophila, and bordetella. vaccination against felv is not warranted in a closed population of cats in which there is no risk of exposure (e.g., most laboratory animal settings). in private catteries, a risk assessment should be done to determine if vaccination is warranted (e.g., cats permitted in outdoor enclosures, frequent introduction of cats from external sources, other opportunities for exposure). special consideration should be given to vaccinating kittens because of their high susceptibility to felv infection and the high likelihood that they will become persistently infected if exposed. in general, felv vaccination is not recommended in animal shelters when cats are housed short term. however, its use is warranted when cats are group housed when resources permit. fiv vaccination is not generally recommended in population environments. a confounding feature of fiv vaccination is that vaccinated cats develop false-positive test results on most commercially available tests (see chapter ) . if fiv vaccination is elected, vaccinated cats should be permanently identified (e.g., by use of a microchip) to help clarify their status. chlamydophila felis (c. psittaci) and bordetella bronchiseptica vaccines may be of benefit when clinical signs of these diseases are present in the population and diagnosis is confirmed by laboratory evaluation. their efficacy is moderate, and reactions are more common than with most other feline vaccines; therefore ongoing use should be periodically reassessed. some vaccines are not generally recommended for use because of undemonstrated efficacy, such as the feline infectious peritonitis (fip) vaccine. wants whenever he or she chooses. dry food is used for this method of feeding, because canned products left at room temperature are prone to spoiling. the major advantage of free choice feeding is that it is quick and easy: caregivers simply need to ensure that fresh dry food is always available. major disadvantages include the fact that cats that are not eating may remain unrecognized for several days, especially when more than one animal is fed together, and some cats may choose to continually overeat and become obese. free choice feeding is an excellent method for cats that require frequent food consumption. these include kittens up to to months of age, queens in late gestation, and those that are nursing. unlike dogs, who are competitive eaters by nature, free choice feeding may benefit cats that are group housed, because it ensures that there will be ample time for all members to eat, provided that dominant members of the colony do not block the access of subordinate cats. meal feeding using controlled portions of dry and/or canned food may be done as an alternative to or in conjunction with free choice feeding. when used alone, a minimum of two meals should be fed per day. meal feeding is ideal for any cat that requires controlled food intake and facilitates monitoring of appetite. meal feeding also has the benefit of enhancing caregiver-cat bonding and provides a pleasant and predictable experience for cats when done on a regular daily schedule. using a combination of free choice plus once daily meal feeding takes advantage of the positive aspects of both methods and works well for most cats in a population setting. typically, dry food is available free choice, and a small meal of canned food is offered once daily. this combination approach accommodates the normal feeding behavior of cats by allowing them to eat several smaller meals throughout the day while allowing caregivers to monitor the cat's appetite at least for the canned food meal. as necessary for the individual cat, some may be fed additional meals of canned food to ensure adequate nutritional support. good body weight and condition and a healthy hair coat are evidence of an adequate nutritional plane and proper nutritional management. both appetite and stool quality should be monitored daily. normal stools should be well-formed and medium to dark brown. adult cats typically defecate once daily, although healthy adults may defecate anywhere between twice a day and twice a week. kittens tend to produce a larger volume of stool more frequently, which is often lighter in color and softer in form than that of adults. simple scales can be used for monitoring appetite (e.g., good, some, none), and fecal scoring charts are available. the author recommends the purina fecal scoring system chart available from nestlé purina petcare company (figure - ) . for breeding is recommended. in animal shelters, spaying and neutering cats prior to adoption will ensure that they do not reproduce and contribute to the surplus of community cats. this will also serve to enhance husbandry, because the procedures rapidly decrease spraying, marking, and fighting; eliminate heat behavior and pregnancy; and greatly mitigate stress. in addition to reducing stress and odor, spaying and neutering sexually mature cats will facilitate group housing, which is often beneficial for cats, especially when housed longer term (see below). the medical benefits of spay/neuter have also been well described, including dramatic reductions in the risk of mammary carcinoma, elimination of cystic endometrial hyperplasia, pyometra and ovarian cancer in queens, and decreased risk of prostate disease in toms. thus spaying and neutering favors both individual as well as population health. proper nutrition has a profound impact on wellness. not only is it essential for management of healthy body weight and condition, good nutrition is also known to support immune function. a regular diet of palatable commercial food consistent with life stage should be offered, and fresh water must always be available. although some cats tolerate changes in food without apparent problems, it is important to recognize that for others, changing from one diet to another can cause loss of appetite and/or gastrointestinal upset. for this reason, it is generally best to provide the most consistent diet possible. whereas this may be relatively easy to do in a laboratory or cattery setting, it can be more challenging in a shelter environment. some pet food companies offer feeding programs for animal shelters, providing a consistent food for purchase at a special rate for shelters. however, some shelters rely heavily on donations of food. in this case, by requesting donation of certain brands of food, shelters are able to provide a consistent diet whenever possible. it is also feasible to mix donated foods with the shelter's usual diet to minimize problems caused by abrupt diet changes while taking advantage of other donated products. the wild ancestors of domestic cats hunted to eat, feeding up to times in a -hour period. this style of feeding behavior is preferred by many domestic cats that would nibble throughout the day and night, consuming many small meals if left to their own devices. although this is true, most cats are capable of adapting to either free choice or meal feeding as their daily feeding pattern. , there are advantages and disadvantages to each in a population setting. with free choice or ad libitum feeding, food is always available such that a cat can eat as much as he or she trends in body weight, because both weight loss and gain can compromise health and well-being. appropriate grooming is also essential to ensure wellness and must never be considered as optional or purely cosmetic. most cats require minimal grooming because of their fastidious nature. however, long-haired cats are notable exceptions, often experiencing matting of the hair coat without regular grooming sessions. matted hair coats are not only uncomfortable for the animal, but may lead to skin infection. overgrown nails can also be a problem for some cats, particularly those that are geriatric or polydactyl. the provision of appropriate surfaces for scratching will encourage cats to condition their own claws; and a system for regular inspection of the hair coat and nails should be established. in addition to ensuring proper coat and nail maintenance, regular grooming sessions provide an excellent opportunity to monitor body condition; and some cats enjoy the physical contact and attention. in high-risk settings, the use of stainless steel combs or undercoat rakes that can be readily disinfected are generally preferable to the use of in addition to appetite and stool quality, it is essential to monitor body weight and condition. body condition can be subjectively assessed by a process called body condition scoring, which involves assessing fat stores and, to a lesser extent, muscle mass. fat cover is evaluated over the ribs, down the top line, tail base, and along the ventral abdomen and inguinal (groin) areas. body condition score charts have been established on scales of to and to . the author recommends use of the purina body condition score chart which is based on a scale of to with being emaciated and being severely obese (see figure - ). cats should be weighed and their body condition scored at routine intervals. ideally, body weight should be recorded at entry to the population and then weekly during the initial month of care, after which it could be recorded once a month or more often as indicated based on the individual's condition. this is especially important for cats, because significant or even dramatic weight loss may be associated with stress or illness during the first few weeks of confinement in a new setting. on the other hand, in long-term-housed cats, excessive weight gain may occur in some individuals. therefore protocols must be in place to identify and manage unhealthy score -very moist (soggy); distinct log shape visible; leaves residue and loses form when picked up. score -very moist but has distinct shape; present in piles rather than as distinct logs; leaves residue and loses form when picked up. score -has texture, but no defined shape; occurs as piles or as spots; leaves residue when picked up. score -watery, no texture, flat; occurs as puddles. score -firm, but not hard; should be pliable; segmented appearance; little or no residue left on ground when picked up. score -log-like; little or no segmentation visible; moist surface; leaves residue, but holds form when picked up. fecal scoring system bristle brushes because the latter are impossible to disinfect and have the potential to spread common skin infections such as ringworm. dental health is another component of wellness. in the context of population wellness, it may not be the highest priority; however, it should always be a consideration in terms of individual health care and well-being. this is important because periodontal disease will occur unless it is actively prevented, and plaque and tartar buildup may contribute to serious health concerns, ranging from oral pain to chronic intermittent bacteremia and organ failure. feline tooth resorption and gingivostomatitis are also common conditions of the feline oral cavity that can lead to chronic pain, affecting the cat's appetite and ability to self-groom, and negatively impacting quality of life. when painful dental disease is present, a plan for timely treatment should be identified and implemented. preventive dental care may include tooth brushing, dental-friendly diets, and treats and chew toys in combination with periodic professional dental care. these should be tailored to meet the needs of individuals in the population to optimize dental health. cats with stomatitis should be removed from breeding programs. wellness protocols may also be dictated by the specific needs of certain breeds of cats. for example, persian, himalayan, and other brachycephalic cats are predisposed to respiratory disease and tend to be more severely affected than other cats because of their poor airway conformation. because of the high likelihood of exposure in a shelter setting, these cats should be housed in highly biosecure areas that are well ventilated and should be prioritized for immediate adoption or transfer to foster care or rescue. in the author's experience, even intranasal vaccination of these breeds can result in severe clinical signs of respiratory disease and is best avoided. just as a physical wellness program must be tailored to the population in question, a behavioral wellness program, composed of all of the essential elements, should be created to meet its specific needs as well. even when animals will only be housed for short periods, considerations for behavioral care are essential to ensure humane care. short-term confinement can induce severe stress and anxiety, and when confined long term, cats may suffer from social isolation, inadequate mental stimulation, and lack of exercise. a behavioral wellness program should strive to decrease stress from the moment cats arrive at a facility until the moment that their stay ends. as previously described, a thorough behavioral history will provide an important baseline for action and follow-up. understanding the importance of minimizing stress in cats and possessing the ability to recognize and respond to it are essential to facilitate a cat's transition into a population. , staff should be trained to evaluate cats beginning at intake and to recognize and respond to indicators of stress. active daily monitoring of cats for signs of stress or adjustment should be performed, and staff should record their findings daily, noting trends and making adjustments in the care of individual cats and the population as indicated. in animal shelter environments, proper behavioral care of cats also requires an understanding of the wide spectrum of feline lifestyles and an approach tailored to the individual needs of each group. domestic cat lifestyles and levels of tractability range from the most docile, sociable housecat, to free-roaming strays and truly unsocialized feral cats that will not allow handling. stray cats include those that may have been previously owned or are "loosely owned" neighborhood or barn cats. because of their lack of socialization, capture, handling, and confinement are especially stressful for feral cats. however, fearful cats may resort to overt aggressive or may "teeter on the edge" of defensive aggression regardless of their socialization status. in fact, even the tamest house cats may exhibit the same behaviors as feral cats when they are highly stressed (figure - ) . , these responses can compromise cat welfare and staff safety and hinder adaptation to a new environment. regardless of their demeanor, all cats and kittens should be provided with a hiding box in their enclosure at the time of entry, because the ability to hide has been shown to substantially reduce feline stress. for those cats that are severely stressed or reactive, covering the cage front, in addition to providing a hiding box, and posting signage to allow the cat "chill out" time for several hours or even a few days can facilitate adaptation. this is important because, once highly stressed or provoked, cats often remain reactive for a prolonged time and may become more reactive if they are stimulated again before they have been allowed a period of time to calm down. soft bedding should be available for comfort and so that cats may establish a familiar scent, which aides in acclimation to a new environment. care should be taken during cleaning procedures to minimize stress and noise, behavioral evaluation may be useful, especially for cats that will be re-homed. several evaluations have been recommended, but none are scientifically validated for predicting future behavior with certainty. , , nonetheless, this form of evaluation may be useful for determining behavioral needs while cats remain in a facility, as well as guiding appropriate placement. box - describes common components of a feline behavioral evaluation (figure - ) . housing design and operation can literally make or break the health of a population. regardless of the species in question, housing should always include a comfortable resting area and allow animals to engage in species-typical behaviors while ensuring freedom from fear and distress. it is not sufficient for the design to address only an animal's physical needs (e.g., shelter, warmth). it must meet their behavioral needs as well, and both the structural and social environment are essential considerations for housing arrangements. furthermore, the environment must provide opportunities for both physical and mental stimulation, which become increasingly important as length of stay increases. a sense of control over conditions is well recognized as one of the most critical needs for behavioral health. thus housing design must provide cats with a variety of satisfying behavioral options. specifically, housing arrangements must take into account the following feline behavioral needs : • opportunities for social interactions with humans and/or other compatible cats and cats should be allowed to hide while their cage is quietly tidied and replenished around them as needed. commercially available "cat dens" are ideal for this purpose, because they can be secured from a safe distance such that the cat is closed inside a secure, familiar hiding place during cleaning procedures (figure - ) . cats should be returned to the same cage and only spot cleaning should be performed to preserve their scent, which is necessary for stress reduction. if it becomes necessary to house the cat in another location, the den and towel should accompany the cat to ease the transition. finally, the use of commercially available synthetic analogues of naturally occurring feline facial pheromones (feliway, veterinary product laboratories, phoenix, ariz.) have been shown to be useful for stress reduction in cats during acclimation to new environments and can be sprayed onto bedding and allowed to dry prior to use or dispersed in the room using plug-in diffusers. the way in which cats are handled at intake has a profound impact on their behavior, health, and wellbeing and will impact the cat's ability to adapt to its new environment. when stress is successfully mitigated, cats are more likely to adapt and to "show their true colors" rather than reacting defensively. during a period of a few days, many cats that did not appear to be "friendly" at intake will become tractable and responsive to their human caregivers, facilitating care. aside from informally "getting to know" cats during their initial acclimation period in a facility, a systematic • the ability to create different functional areas in the living environments for elimination, resting, and eating • the ability to hide in a secure place • the ability to rest/sleep without being disturbed • the ability to change locations within the environment, including using vertical space for perching • the ability to regulate body temperature by moving to warmer or cooler surfaces in the environment • the ability to scratch (which is necessary for claw health and stretching, as well as visual and scent marking) • the ability to play and exercise at will • the ability to acquire mental stimulation because these needs will vary depending upon such factors as life stage, personality, and prior socialization and experience, facilities should maintain a variety of housing styles in order to meet the individual needs of different cats in the population (figure - ) . managing housing arrangements for a population of cats of varying ages, genders, personality types, social experiences, and stress levels requires knowledge of normal feline social behavior and communication. during the past decades, knowledge of feline social structure has evolved from the widespread belief that cats are generally an asocial and solitary species to the realization that they are social creatures. , with the exception of solitary hunting, free-roaming cats perform responses are observed and recorded for each of the following: • the tester approaches cage, stands quietly for seconds, then offers verbal encouragement. • if deemed safe to proceed, tester opens the cage door and calmly extends an open hand towards the cat, then attempts to gently touch the cat's head. • if the caregiver is unsure if this is safe to do, a plastic hand may be used to gauge the cat's receptiveness to touch (see figure - ). • if the cat allows handling, the cat is gently lifted and carried to a secure, quiet room for further observation. • the tester sits quietly on a chair and/or the floor; the tester calls and solicits the cat's attention. • the tester pets the cat on the head. • the tester strokes the cat down the back several times. • the tester picks up the cat and hugs it for seconds. • with the cat standing on the floor, the tester strokes the cat down the back and firmly but gently grasps the base of the tail and lifts the cat off of its hind feet for second. the tester repeats this a second time. • the tester engages the cat in play with an interactive toy. in some instances, it is difficult to determine if a cat will accept handling. to prevent injury to staff, a plastic hand (assess-a-hands; great dog productions, accord, ny) is used to approach this cat. as the hand approaches, the cat appears tense (a) but begins to relax and accepts petting (b and c) . the absence of normal behaviors (e.g., grooming, eating, sleeping, eliminating, stretching, greeting people). defensive behavior may involve characteristic postural and/or vocal responses, and is usually motivated by fear. disruptive behavior involves destruction of cage contents and creation of a hiding place. stereotypic behaviors (e.g., repetitive pacing, pawing, and circling) may also develop as a result of stress but generally occur less commonly. as an illustration of these feline behaviors, consider the responses of a typical social domestic cat when caged in a novel environment (box - and figures - to - ) . behavioral signs of stress may be further classified as active communication signals or passive behaviors. , signals of anxiety, fear, aggression, and submission may be subtle or obvious and include vocalization (growling, hissing), visual cues (facial expression, posturing of the body, ears, and tail), and scent marking (urine, feces, various glands of the skin). passive signs of stress include the inability to rest/ sleep, feigned sleep, poor appetite, constant hiding, absence of grooming, activity depression (decreased play and exploratory behavior), and social withdrawal. high-density housing exacerbates these signs. lowsocial-order cats in such an environment may exhibit decreased grooming, poor appetite, and silent estrus. cats that are consistently fearful or anxious may hide, most of their activities within stable social groups where cooperative defense, cooperative care of young, and a variety of affiliative behaviors are practiced. affiliative behaviors are those that facilitate close proximity or contact. cats within groups commonly practice mutual grooming and allorubbing (e.g., rubbing heads and faces together). this may serve as a greeting or as an exchange of odor for recognition, familiarization, marking, or development of a communal scent. cats of both genders and all ages may exhibit affiliative behaviors, and bonded housemates often spend a large proportion of their time in close proximity to one another. maternal behavior is the primary social pattern of the female cat, and cooperative nursing and kitten care are common. if allowed, queens form social groups along with their kittens and juvenile offspring. , tomcats typically reside within one group or roam between a few established groups. within groups of cats, a social hierarchy or "pecking order" forms. , once established, this hierarchy helps to support peaceful co-existence of cats within a stable group, minimizing agonistic behaviors between members. social hierarchy formation occurs within groups of cats that are sexually intact, as well as in those that are neutered. knowledge of behavioral signaling is critical for successful management of housing arrangements. manifestations of both normal and abnormal behavior indicate how successfully an animal is coping with its environment. common behavioral expressions of feline anxiety may manifest with inhibited or withdrawal behavior, defensive behavior or disruptive behavior. , inhibited or withdrawal behavior refers to activity depression or • fear is typically the initial response, and if threatened by the proximity of unfamiliar caregivers, defensive aggression may be displayed. alternatively, the cat may freeze or appear catatonic. • if provided with a box for concealment, the cat will hide or otherwise slink against the back of the enclosure, behind the litter box, or disrupt the cage and hide under the paper. • given time, most cats become more active and engage in greeting behaviors, coming to the front of the cage and pawing or mewing as caregivers approach. • if the cat remains confined with time without adequate periods of exercise, mental stimulation, and social companionship, stress and frustration will manifest with activity depression and withdrawal (lying in the litter box, failure to groom, failure to greet caregivers, and, in some cases, displaying aggression towards caregivers). • displays of stereotypic behavior (such as pacing) may occur; however, inhibited or withdrawal behaviors are much more common (see unfamiliar or new cats entering the group. within an established group, however, most social conflicts are not characterized by overt aggression. instead, the main mode of conflict resolution is avoidance or deference (figure - ) . , , deference behaviors include looking away, lowering the ears slightly, turning the head away, and leaning backward. large numbers of cats peacefully co-exist together, using such strategies for avoidance provided ample space and resources are available for all members of the group. signs of social stress within groups of cats may manifest with overt aggression, increased spraying and turn their back, huddle, and avert their eyes from the gaze of other cats. hiding is a normal and important coping behavior; however, when hiding is occurring with increased frequency or in response to stimuli that did not previously cause hiding, it should be recognized as a sign of stress. , in group settings, the complexity of the social structure cannot be overestimated. the internal structure of social groups rarely represents a straightforward linear hierarchy, except in very small groups of less than four to five animals. in larger groups of cats, there are usually one or two top-ranking individuals and one or two obvious subordinates, while the remaining cats share the middle space. , most cats within the group form affiliative or friendly relationships; however, some may fail to form such relationships and remain solitary. colony members commonly display aggression toward c marking, or constant hiding. , lower-ranking cats may spend little time on the floor, remaining isolated on single perches or other locations where they may even eliminate, while higher-ranking cats remain more mobile, controlling access to food, water, and litter resources. high-density housing conditions frequently result in such abnormal behaviors and are associated with increases in transmission of infectious diseases and reproductive failure as well. cats are commonly housed in three basic arrangements: cage or condo units, multiple runs within a room, or free ranging in a room. cage housing of cats should be avoided unless necessary for short periods for intake observation, legal holding periods in shelters as required by local ordinances, medical treatment or recovery, or to permit sample collection. although space recommendations vary substantially in the literature, common sense dictates that a determination of necessary housing space should take into account the cat's length of stay. in the author's opinion, it is neither appropriate nor humane to house cats in traditional cage housing long term (e.g., more than to weeks). the design of short-term housing should include provisions for housing individual animals, litters, families, or bonded housemates for intake evaluation and triage. housing must be easy to clean and sanitize, well ventilated, and safe for animals and caregivers. short-term housing should provide sufficient space to comfortably stand, stretch, and walk several steps; sit or lay at full body length; and separate elimination, feeding, and resting areas. litter boxes should be of appropriate size to comfortably accommodate the cats for which they are intended ( figure - ) . resting areas should include comfortable surfaces, soft bedding, and a secure hiding place to provide a safe refuge. a hiding place is essential, because it reduces stress by allowing cats to "escape," facilitating adaptation to a new environment. the addition of a sturdy box to a cage will provide a hiding place as well as a perch (figures - and - ) . in addition, cages should be elevated off of the floor by at least . m ( . feet), because this serves to reduce stress as well. in most instances, cage or condo style housing is used in most facilities for short-term holding at intake for observation, acclimation, and/or triage. runs or small rooms are also appropriate for intake housing, and offer cats the obvious benefit of additional space to meet their behavioral needs (figure - ) . regardless of their configuration, enclosures for short-term housing of cats should be large enough to allow them to stretch, groom, and move about while maintaining separate functional areas, at least . m ( feet) apart, for sleeping, eating, and elimination. , , laboratory guidelines in the united states call for a minimum floor area of . m ( ft ) for cats weighing less than kg and . m ( ft ) for cats weighing kg or more, with a minimum height . m ( ft). a resting upper respiratory infections. double-sided enclosures (e.g., cat condos) are ideal for meeting these specifications and have the benefit of easily allowing cats to remain securely in one side of the enclosure while the opposite side is cleaned (figure - ) . this helps to minimize stress, prevent exposure to infectious disease, perch is also required. current guidelines (european convention for the protection of vertebrate animals used for experimental and other scientific purposes, ets ) promulgated by the council of europe (http:// www.coe.int) for laboratory cats are similar, but proposed revisions call for substantially more floor space for cats, at . m ( . ft ) per adult cat with a height of at least m ( . ft). , the revisions, which have not been approved to date, also call for the provision of shelves, a box-style bed, and a vertical scratching surface. animal shelter facilities in the united states have traditionally been equipped with small perchless cages (e.g., . to . m or . to . ft long) that are poorly designed for housing cats. the association of shelter veterinarians (http://www.sheltervet.org) recommends a minimum enclosure size of m ( ft ) for adult cats. commercially available cages are typically approximately . m ( . ft) deep (e.g., an arm-length deep so that they can be readily accessed); therefore a cage with a length of . m ( ft) is required to provide this approximate square footage, and it will also allow for adequate separation of food, water, and litter ( figure - ) . similarly, the cat fanciers' association (http:// www.cfa.org) recommends a minimum of . m ( ft ) of space per cat for those weighing kg or more. cubic measurements take into account the use of vertical space in addition to floor space, which is crucial for improving the quality of the environment. for example, a . -m ( - larger enclosures also allow for better air circulation, which is an important consideration for control of feline housing for a single cat. note the large -ft long cage, provision of a secure hiding place and perch with bed, separation of litter from resting and feeding areas, and appropriately sized litter box for this large cat. housing units are available for cats and serve to separate functional living areas and provide improved opportunities for exercise and exploration. this unit (tristar metals, boyd, tex.) is constructed of powder-coated stainless steel, which is highly durable and easy to disinfect but less noisy than uncoated stainless steel. note the elevation from the floor and the grills on both the front and back, which allows flow-through ventilation. is both mentally and physically stimulating for cats and preferably that which is esthetically pleasing to humans. the latter is an important consideration to facilitate adoption in animal shelters. and, even in other types of facilities, it is important to create a pleasant environment not only for the animals, but also for their caregivers. studies indicate that employee satisfaction improves animal care and staff retention, both of which may positively impact population health and well-being. for long-term housing of cats alternatives to traditional cage housing should be afforded. , , at an absolute minimum, cats that are cage housed must be released each day and allowed an opportunity to exercise and explore in a secure enriched setting. for long-term housing, most cats will benefit from colony-style housing, provided there is sufficient space, easy access to feeding and elimination areas, an adequate number of comfortable hiding, and resting places and careful grouping and monitoring to ensure social compatibility among cats. not every cat, however, will thrive in a group setting, and certain individuals will require enriched single housing, depending on their unique physical or behavioral needs. these may include cats that bully other cats or are otherwise incompatible and those with special medical needs. it is important to recognize that such singly housed cats will require more regular contact with their human caregivers and higher levels of mental and physical stimulation in order to maintain behavioral health during long-term confinement. whenever possible, long-term housing of such individuals should be avoided. when cats are housed in amicable groups, it is easier to maintain proper behavioral welfare in the long term, because many of their social and emotional needs can be met by conspecifics. group housing affords cats with opportunities for healthy social contact with others, which, in turn, provides additional mental and physical stimulation. when properly managed, this housing arrangement enhances welfare.* insufficient space and crowding or poor compatibility matching of cats serves to increase stress and negates the benefits of the colony environment. group housing should never be used as a means of simply expanding the holding capacity of a facility. in animal shelters, the high turnover rate of cats contributes substantially to feline stress levels, especially in the context of groups of unfamiliar animals. because it may take days to weeks to acclimate to a group environment, enriched individual housing may be preferable when a brief stay is anticipated. however, the benefits of enriched social group housing become evident when stays extend beyond a few weeks. and preserve staff safety, which are especially crucial for newly arrived cats. traditional cages can be modified into condo-style enclosures by creating portals to adjoin two or three smaller cages (figure - ) . regardless of the precise specifications of the enclosures, the importance of the overall quality of the living environment cannot be overemphasized. this includes a holistic approach to husbandry, with careful attention to the way in which cats are handled, noise levels, the provision of creature comforts, positive contact with caregivers, and strict avoidance of overcrowding, as well as good sanitation, medical protocols, and careful monitoring to ensure health and welfare. for long-term housing (e.g., greater than weeks), consideration should also be given to providing space that a b *references , , , , , , , , , , . breeding age should be avoided whenever possible. at a minimum, mature tomcats should be neutered to prevent intermale aggression, urine spraying, and breeding. reproductively intact females may be co-housed with other intact females or with neutered males. in contrast, in breeding colonies, harem-style housing may be used to facilitate breeding (e.g., a few queens with a tomcat). it is also advantageous to house compatible pregnant queens together before delivery, because they will usually share nursing and neonatal care ( figure - ) . after delivery, pairing of queens becomes more difficult. when tomcats are not breeding, they can usually be co-housed with a spayed female, a neutered male, or a compatible juvenile for companionship. other recommended groupings in the context of a breeding colony include postweaning family groups, prepubertal juveniles, or compatible single-sex adults. personality type there are two basic feline personality types: cats that are outgoing, confident, and sociable and those that are relatively timid and shy. cats with bold, friendly temperaments tend to cope and adapt more readily than shy, timid cats. a subset of the bold, friendly personality type is the "assertive" or "bully" cat. bully cats constantly threaten other cats in a group setting in order to control access to food, litter, perches, or the attention of human caregivers. to maintain harmony, removing cats of this personality type from a colony is usually necessary. reassignment is possible, but may prove difficult, necessitating single housing. shy, timid cats sometimes have difficulty interacting successfully with more dominant members of a group or may fall victim to a bully, resulting in chronic stress and increased hiding. placement of shy cats in smaller groups or with calm juvenile cats, where they will not be intimidated or harassed, is generally rewarding and often helps them to "come out of their shells." , similarly, dominant cats will often accept calm, younger cats, as opposed to other adults by whom they may feel threatened. and finally, in the case of some dominant males, the introduction of a female cat will be more likely to be successful. , , the precise space requirements for long-term housing of cats will vary, because it is dependent on many factors (box - ). , of paramount importance is that group size must be small enough to prevent negative interactions among cats and to permit daily monitoring of individuals. cats typically prevent social conflict through avoidance, and adequate space must be available so that cats can maintain social distance as needed. crowding can make it impossible for animals to maintain healthy behavioral distance, creating situations where individuals may not be able to freely access feeding, resting, or elimination space because of social conflicts over colony careful attention to groupings of cats is essential for success. family groups and previously bonded housemates are natural choices for co-housing, , but unfamiliar cats may also be grouped using careful selection criteria. many cats do have preferences for housemates, necessitating conscientious compatibility matching combined with the provision of a high-quality environment. groupings of unfamiliar cats should always be given priority for the largest available enclosures. in addition, cats should always receive appropriate health clearances prior to admission to a group. these should be determined by the specific protocols of the facility; but in most cases, minimum requirements would include that cats be free of signs of contagious disease, tested for felv and fiv, vaccinated against fvrcp, and treated for parasites. in addition to prior relationships, selection criteria for groupings should include age, reproductive status, and personality. age age is an important consideration regarding housing arrangements. to ensure proper social and emotional development, kittens should be housed with their mother at least until they are weaned. because it can be behaviorally beneficial, it is desirable for them to remain with her for a longer period of time when this is feasible. in fact, queens frequently do not fully wean their kittens until to weeks of age if left to their own devices. if older kittens are housed with their mother, it is important to provide a perch that allows her the option of periodically resting away from them if desired. most queens will accept the kittens of another cat; therefore young orphan or singleton kittens should be housed with other lactating queens and/or kittens of similar age/size. in a shelter setting where there is a high turnover of cats, it may be beneficial to house young kittens up to to months of age in large cages or condos for biosecurity purposes. juveniles and adults can be housed in colony rooms or runs but should be segregated by age (e.g., juveniles to months old, young adults, mature adults, geriatrics). well-socialized juveniles tend to adapt quickly in a group setting with other cats of similar ages and exhibit healthy activity and play behavior. in contrast, mature adults and geriatric cats often have little tolerance for the high energy and playful antics of many younger cats, which can cause them substantial stress. for this reason, adult cats should be kept separate from juvenile cats, and aging or geriatric cats separate from other age groups. in animal shelters, compatible cats that enter the shelter together should be housed together regardless of age, whenever possible. unless cats will be used for breeding, group housing of sexually intact cats of all of these reasons, housing cats in small groups is preferred. , , in most instances, the author recommends housing cats in compatible pairs or small groups of not more than three to four individuals. housing cats in runs is ideal for this purpose (figure - ) . a well-equipped, . -× . -m ( -× -ft) run can comfortably house two to three adult cats depending on their familiarity and compatibility, or up to four juveniles (e.g., to months old). juveniles tend to accept a slightly higher housing density than adults. likewise, previously bonded housemates and families will generally peacefully co-exist at a higher density than will unfamiliar cats. when runs are used, they must have a top panel and should be at least . m ( ft) high to allow caregivers easy access for cleaning and care. if chain-link is used, . -cm ( -inch) mesh is ideal, but larger mesh can be used. existing dog kennel runs can be converted into areas for cat housing. this is an important and practical consideration in animal shelters, because many shelters have experienced a decrease in dog intake, while the need for improved cat housing is great. cats and dogs should never be co-housed in the same area; thus conversion should result in an exclusive cat housing area. for colony rooms, the author recommends a minimum enclosure size of approximately to . m × to . m ( to ft × to ft) for colonies of up to a maximum of eight adult cats, or in the case of juveniles, a few more. doubling the size of an enclosure does not necessarily allow a twofold increase in the number of cats that can be properly housed. another author recommends . m ( ft ) per cat as a general guideline for group housing, resources. both crowding and constant introduction of new cats induce stress and must be avoided to ensure proper welfare. the addition of new cats always results in a period of stress for the group, and if there is constant turnover within the group, cats may remain stressed indefinitely. high turnover also increases the risk of infectious disease. if cat group numbers are small, disease exposure will be limited, facilitating control. for • length of stay • overall quality of the environment, including use of vertical space • overall quality of behavioral care • physical and behavioral characteristics of the cat (e.g., age, personality type, prior experience, and socialization) • individual relationships between cats (e.g., family groupings, previously bonded housemates, versus unfamiliar groupings and degree of social compatibility among cats) • turnover of cats (e.g., frequency of introduction of new members) • total room size • absolute number of cats • individual needs and levels of enrichment being used to meet these needs enabling caregivers to better monitor individual appetites and litter box results while allowing cats a period of rest away from one another. alternatively, individual enclosures may only be used for brief periods for meal feedings of canned food, with dry food available free choice in the colony. this sort of arrangement can also be used to facilitate introduction of new cats to the group and represents a desirable option. if design and biosecurity procedures permit, portable intake enclosures could even be transferred to group rooms to smooth the transition of new cats from intake to long-term housing areas. tremendous individual variation exists among cats in the context of social relations with other cats. although introduction of some previously unfamiliar cats will seem effortless and uneventful, introduction of others will result in considerable stress, not only for the new cat but for the entire group as well. for this reason, introductions should always be done under supervision, and whenever possible, they should be gradual. to accomplish this, a new cat can be kept in a separate cage within or adjacent to the group enclosure equipped with food, water, litter, and a hiding box. usually, within a few days, it will be evident by the behaviors of the cats whether or not the new cat can be transferred into the group enclosure without risk of fighting. wellsocialized kittens and juvenile cats frequently adapt readily to group accommodations, and prolonged introductions may not be necessary unless they are shy or undersocialized. in established groups of cats, the introduction or removal of individuals will require a period of adjustment and may result in signs of social stress for members of the colony. these signs usually subside once a new social hierarchy and territorial limits (usually favored resting places) are established. in some cases, arrangement of incompatible cats, even within visible distance of one another, may create substantial anxiety, necessitating rearrangement (figure - ) . in the case of animal shelters, where population interchange is high, it is generally not feasible to maintain consistent groupings of cats. this underscores the absolute necessity of careful selection and compatibility matching, as well as maintaining a variety of housing styles. even in modestly populated, carefully introduced, environmentally enriched colonies, behavior problems may occur. for this reason, some facilities elect to use an "all in-all out" approach to avoid repeated introductions of new cats into stable groups. in animal shelters, bonded pairs and family groupings of cats frequently enter the shelter together and are usually perfect choices for co-housing. because cats do have strong preferences for new roommates, caregivers must expect to find many that are incompatible as roommates. if only one or two cats are responsible for social destabilization of a group, they can acknowledging that many factors influence the spatial needs of cats, including the overall quality of the environment as well as the relationships of the individual animals. in sanctuary and laboratory situations where cats are housed for months to years in stable colonies, larger groupings of cats may be feasible, provided ample space is available. housing arrangements can also be created in which individual enclosures are maintained within a colony room. in this case, cats could be allowed to wander and interact freely in the colony room by day but be confined to their respective enclosures at night, for pair-housing of two adult cats. note the multiple separate areas for resting, perching, hiding, feeding, eliminating, scratching, and playing. b, cats enjoy the increased behavioral options provided by run-style housing. should exceed the number of cats and should be arranged in as many locations within the enclosure as possible. open single perches should be separated by at least . m ( ft) or staggered at different heights to ensure adequate separation, while larger perches should be available for cats who choose to rest together in close proximity. many cats enjoy hammock-style perches or semienclosed box-style perches where they can hide. if there are not enough comfortable, desirable resting and hiding places, cats may choose to lie in litter boxes. comfortable bedding (that is either disposable or can be easily laundered) should be provided. not only do cats demonstrate preferences for resting on soft surfaces, they experience longer periods of normal deep sleep with soft bedding. the environmental temperature should be kept comfortable and constant, and living quarters should be well ventilated, without drafts. by changing location within the colony (e.g., from the cooler surface of the floor to a sunny window), cats should be able to choose the environmental condition they prefer (figure - ) . in colony rooms, installation of stairs, shelves, and walkways are ideal for increasing the use of vertical space (figure - ) . in larger rooms, installation of freestanding towers provides additional living and activity space and contributes to functionally reducing overcrowding (figure - ) . depending on the setting, it may not be desirable for cats to access areas above the level of an arm's reach so that cleaning is easy and cats can be easily retrieved from the highest perches if needed. colony room design should also ensure that cats cannot easily escape. in some cases, constructing a foyer at the entrance to the room will be necessary to minimize the risk of escape when the room is entered (figure - ) . in addition, ceilings should be constructed of solid surfaces, because cats can easily dislodge the usually be reassigned to another colony, because it is often the social grouping, not the individual, that is the problem. if a cat shows persistent incompatibility with other cats, he or she should be housed singly. studies indicate that cats that fight at the time of initial introduction are nearly times more likely to continue fighting in the following weeks and months. if overt fighting occurs, cats should be permanently separated. cohousing of incompatible cats or cats that fight is unacceptable. the success of group housing depends not only on selection of compatible cats and the size of the enclosure but also on the quality of the environment.* a variety of elevated resting perches and hiding boxes should be provided to increase the size and complexity of the enclosure and to separate it into different functional areas, allowing a variety of behavioral choices. the physical environment should include opportunities for hiding, playing, scratching, climbing, resting, feeding, and eliminating. whenever possible, a minimum of litter box and food and water bowl should be provided per to cats and arranged in different locations of the colony space, taking care to separate food and water from litter by at least . m ( ft). in addition, placement should allow cats to access each resource from more than one side, whenever possible, without blocking access to doorways. litter boxes should not be covered, to allow easy access and to prevent entrapment or ambush by other cats. the number of resting boards and perches the importance of a cat-savvy staff that enjoys working with cats cannot be overemphasized. animal care staff must be willing to spend quality time interacting with cats to assure socialization and tractability. , whenever possible, caregivers should be assigned to care for the same cats on a regular basis so that they become aware of the personality of each individual cat, which is necessary for detection of health problems, incompatibilities between cats, and, in the case of breeding colonies, estrous cycling. this is also important, because not all cats uniformly enjoy human companionship and will be more likely to be stressed by the presence of different caregivers, rather than becoming familiar and more at ease with one. in general, regular daily contact and socialization is essential to ensure that cats are docile, easy to work with, and have no fear of humans. caregivers should schedule time each day to interact with "their" cats aside from the activities of feeding and cleaning. some cats may prefer to be petted and handled, while others prefer to interact with caregivers by playing with toys (figure - ) . in particular, human contact is essential for proper socialization of young kittens. a sensitive period of socialization occurs during the development of all infant animals, during which social attachments to members of the same species and other species form easily and rapidly. in kittens, the sensitive period of socialization occurs between and weeks of age, and cats not properly socialized to humans during this time may never permit handling. , beginning shortly after birth, kittens should be handled daily, talked to in a soothing panels typically used for dropped ceilings, and escape into the rafters (figure - ) . in addition to contact with conspecifics, cats must be afforded time for pleasant daily contact with human caregivers. as previously discussed, daily social contact and exercise sessions with humans are especially important for individually caged cats. although social contact is usually highly desirable, it is not invariably pleasant for all cats. personality, socialization, previous experience, and familiarity contribute to whether or not social interactions are perceived as pleasurable, stressful, or somewhere in between. , a b voice, gently petted, and held. interactions should include play (stimulated with toys) as the kittens become ambulatory. for kittens housed in a shelter, socialization must always be balanced with infectious disease control, and caregivers should take precautions accordingly. other forms of stimulation, including those that engage the various senses, are important methods of enriching the living environment by promoting healthy mental and physical activity. for singly housed cats and longterm residents, appropriate levels of additional enrichment should be provided on a daily basis. the provision of birdfeeders, gardens, or other interesting stimuli in the external environment can enhance the internal environment of the colony. resting perches in view of windows or other pleasant areas of the facility are especially desirable. other novel and enriching visual stimuli include cat-proof aquariums with fish, water fountains, bubbles, perpetual motion devices, and videos especially designed for cats (figures - to . a radio playing soft, low music in the room provides a welcome distraction and important source of play items that stimulate prey drive and physical activity, such as plastic balls, rings, hanging ropes, springmounted toys, plastic wands, and catnip toys, should also be provided but must be either sanitizable or disposable. empty cardboard boxes and paper bags are inexpensive, disposable, and stimulate exploration and play behavior as well as scratching. cats tend to be most stimulated by active toys, including wiggling ropes, wands with feathers, kitty fishing poles, and toys that can be slid or rolled to chase. many cats enjoy chasing stimulation. in addition, it may help to habituate cats to human voices and prevent them from being startled by loud noises. most caregivers also enjoy listening to the radio, and happy caregivers create a relaxed environment. the provision of scratching boards is especially important, and a variety of sturdy surfaces, both horizontal and vertical, should be provided for scratching. sisal rope, the backs of carpet squares, and corrugated cardboard are all useful (figure - ) . many cats like to smell and chew grass, and containers of cat grass or catnip can be introduced for brief periods to stimulate activity (figure - ) . providing novel sources of food is another important source of stimulation and can be easily accomplished by hiding food in commercially available food-puzzle toys or in cardboard boxes or similar items with holes such that the cat has to work to extract pieces of food ( figure - ) . , positive reinforcement-based training obedience training using clickers with food rewards is an excellent form of enrichment, combining social contact with caregivers together with both mental and physical stimulation. positive reinforcement training using a target stick is a powerful tool for teaching shy cats to approach the front of an enclosure. teaching cats awaiting adoption to perform tricks is not only stimulating for them, but it often makes them more attractive to potential adopters (figure - ) . a cardboard tube, and a plastic container with holes). treats are hidden inside, and they will have to work to extract pieces of food. novel feeding is an excellent source of enrichment for cats that are housed long term. (e.g., feeding, cleaning, enrichment activities), and unpredictable caregiving has been shown to dramatically increase stress. if events that are perceived as stressful (such as cleaning time) occur on a predictable schedule, cats learn that a predictable period of calm and comfort will always occur in between. cats also respond to positive experiences in their daily routines. for example, feeding and playtime may be greatly anticipated; thus scheduling positive daily events (e.g., a treat at : pm every day) should also be a priority. erratic periods of light and darkness are also known to be significant sources of stress for cats. animals possess natural circadian rhythms and irregular or continuous patterns of light or darkness are inherently stressful. lighting should be maintained on a regular the beams of laser pointers, small flashlights, or suspended rotating disco balls. commercially available electronic toys that stimulate play are especially useful in long-term settings (figure - ) . varied toys should be substituted regularly to ensure continued interest. in some climates, cats may be housed comfortably in outdoor enclosures where fresh air, sunshine, and other stimuli can help to create a healthy environment ( figures - and - ) . , , when indoor group enclosures connect to outdoor enclosures, it is important to have ample space for passage between them (e.g., more than one doorway) so that cats can pass freely. cats will also benefit greatly from consistent daily routines of care. they become entrained to schedules of care adoption, or euthanasia (when no other options exist) may be necessary to ensure cat welfare. achieving population wellness requires a healthy environment. thus the clinician's final task in creating a population wellness program is to develop tailored schedule, with lights on by day and off by night. whenever possible, full-spectrum and/or natural lighting is ideal. housed cats require active daily monitoring by staff trained to recognize signs of stress and social conflict. to the inexperienced observer, such signs may appear subtle (figure - ) . it is often the absence of normal behaviors (such as engaging in grooming or exercise) or subtle social signals (such as covert guarding of resources or dominant staring) that signify problems. careful observers will note these behaviors and respond accordingly to ensure that stress or conflicts do not persist. when cats are well adjusted and housing arrangements meet their behavioral needs, they display a wide variety of normal behaviors, including a good appetite and activity level, sociability, grooming, appropriate play behavior, and restful sleeping (figure - ) . , ultimately, the success of adaptation of cats to a new environment will depend on both the quality of the environment and the adaptive capacity of the individual. although most adapt to new environments with time, some never adjust and remain stressed indefinitely, ultimately resulting in decline of physical as well as emotional health. when cats fail to adjust to their environment and remain markedly stressed and fearful despite appropriate behavioral care, every effort must be made to prevent long-term stays. depending on the circumstances, transfer to another colony room, foster care, a shelter will result in saving more lives. to the contrary, euthanasia rates are highly correlated to intake rates, regardless of the number of animals that a facility houses. in many instances, keeping more animals in the shelter may actually reduce the organization's ability to help animals, because time and resources are tied up caring for a crowded, stressed population, rather than focusing on adoption or other positive outcomes. in shelter medicine, the term population management is used to refer to an active process of planning, ongoing daily evaluation, and responding to changing conditions as an organization cares for multiple animals. , the major goal of population management is to minimize the amount of time any individual animal spends confined in the shelter, while maximizing the organization's lifesaving capacity. moving animals through the system efficiently is the foundation of effective population management. to move animals through the shelter more quickly, delays in decision making and the completion of procedures (e.g., intake processing, transfer from holding to adoption areas, spay/neuter surgery) must be eliminated or minimized whenever possible. in openadmission shelters, even delays of to days can have a dramatic effect on the shelter's daily census, particularly for shelters handling thousands of animals per year. this, in turn, affects the ability to provide adequate care. it is important to recognize that effective population management does not change the final disposition of an animal. it does mean that determinations are made as soon as possible, which serves both the individual animal as well as the population as a whole. for wellness programs to be effective, a clean and sanitary environment must be maintained. not only does this promote cat and human health, but it also promotes staff pride as well as public support. in addition to protocols for routine daily cleaning and disinfection procedures, protocols should be in place for periodic deep cleaning and disinfection as well as procedures to be used in the event of disease outbreaks. when crafting protocols, it is important to recognize that cleaning and disinfection are two separate processes. the cleaning process involves the removal of gross wastes and organic debris (including nonvisible films) through the use of detergents, degreasers, and physical action. although this process should result in a visibly clean surface, it does not necessarily remove all of the potentially harmful infectious agents that may be present. disinfection is the process that will destroy most of these agents, but it cannot be accomplished until surfaces have been adequately cleaned. disinfection is usually accomplished through the application of chemical compounds or disinfectants. the most commonly used of these are reviewed in protocols focused on optimizing environmental conditions that favor cat health. once again, all essential elements as noted should be addressed. perhaps the most critical aspect of environmental management is to ensure a modest population density. high population density increases opportunities for introduction of infectious disease while increasing the contact rate among members of a group. both the number of asymptomatic carriers of disease, such as those with upper respiratory infection, as well as susceptible cats in a given group are likely to increase, enhancing the odds of disease transmission among group members through both direct contact as well as fomites. in addition, crowding also increases the magnitude of many environmental stressors (e.g., noise levels, air contaminants) and compromises animal husbandry, all of which induce unnecessary stress and further inflate the risk of disease in the population. indeed, crowding is one of the most potent stressors recognized in housed animals. although adequate space for animals is essential, it is crucial to recognize that crowding is not solely dependent on the amount of available space. it is also a function of the organization's ability to provide proper care that maintains animal health and well-being. every organization has a limit to the number of animals for which it can provide proper care. when more animals are housed than can be properly cared for within the organization's capacity, caregivers become overwhelmed, and animal care is further compromised. , , in animal shelters, crowding may also negatively impact adoption rates, because potential adopters often find crowded environments to be overwhelming and uninviting. if disease spread results as a consequence of the environmental conditions, animal adoptions may be further disrupted. although unexpected shelter intake may occasionally result in temporary crowding, a good wellness program dictates that protocols must be in place to alleviate crowding and maintain a modestly populated environment for the health and protection of the animals and staff. regardless of the setting, facilities must limit the number of animals housed to the number for which they can provide proper space and care. there are three basic methods of reducing crowding: ( ) limiting the admission (or births) of new animals into a population, ( ) increasing release of animals from a population, and ( ) euthanasia. in animal shelters, management practices that minimize each animal's length of stay and programs that speed or increase adoption, owner reunification, or transfer (e.g., to rescue or foster care) help to minimize crowding and maximize the number of animals that an organization can serve. it is a common misperception that housing more animals in • although commonly used, they must be applied to clean hands and allowed seconds of contact time to be effective. • they are highly effective against bacteria, but have only moderate activity against viral agents, including feline calicivirus (fcv). • they should not be used as a substitute for hand washing or the use of gloves. • chlorhexidine is the most commonly used biguanide and is relatively expensive. its major use is as a surgical preparation agent. • although biguanide compounds have broad antibacterial activity, they have limited efficacy against viruses and are ineffective against nonenveloped viruses, such as panleukopenia and fcv. therefore they are not recommended as general-purpose environmental disinfectants. • household bleach ( . % sodium hypochlorite) is the most commonly used chlorine compound and is an excellent, safe, and highly cost-effective disinfectant when used correctly. • at a dilution of : , bleach is highly effective against bacteria and viruses, including nonenveloped viruses, such as panleukopenia and fcv. • solutions must be made fresh daily and stored in opaque containers, because bleach is highly unstable once mixed with water and degrades in the presence of ultraviolet light. • surfaces must be thoroughly cleaned with a detergent, rinsed, and dried prior to the application of bleach, because it is ineffective in the presence of detergents and organic material. • proper disinfection requires minutes of contact time with a bleach solution. • although bleach is not effective when mixed with detergents, it can be safely and effectively mixed with quaternary ammonium compounds, which do provide some cleaning activity. therefore this combination can be used for cleaning and disinfection, provided gross organic material is first removed and adequate contact time is allowed. the addition of bleach improves the disinfection properties of the solution, making it effective against nonenveloped viruses, including panleukopenia and fcv. • concentrations stronger than a : dilution can result in respiratory irritation for both animals and people, as well as increased facility corrosion, and are therefore not recommended for routine use. • at a dilution of : , bleach will destroy dermatophyte spores. however, cats must be removed from the environment prior to application of this concentration. • the use of calcium hypochlorite (wysiwash, st. cloud, fla.) is becoming more common and offers the potential advantages of reduced contact time and a neutral ph, which prevents corrosion. oxidizing agents quarantine involves the holding of healthy-appearing animals. it is most useful when animals enter a closed population to ensure that they are not incubating disease when they are introduced into the general population. quarantine areas, with rigid biosecurity procedures in place, should be used to segregate healthy animals for observation. the use of such areas not only allows apparently healthy animals to be observed for developing signs of infectious disease, but it also allows time for response to vaccination in a highly biosecure environment where exposure risks are minimized. the use of quarantine is a mainstay of effective infectious disease control programs and is intended to prevent the introduction of disease into a population. it should be used whenever it is feasible to implement effectively, such as in a laboratory setting, a private cattery, or a low-volume, limited-admission sanctuary setting. however, quarantine practices are not effective in most animal shelters, because the high volume and turnover of animals precludes proper implementation of a true quarantine where an "all in-all out" system is used. instead, incoming animals are usually added to the "quarantine group" on a daily basis, effectively defeating the purpose of true quarantine and simply prolonging the animal's stay. this is especially concerning given the fact that a cat's length of stay in a shelter is a major risk factor for development of upper respiratory infection. for this reason, the use of quarantine is not recommended in most shelter settings. instead, high biosecurity areas are recommended for housing the most susceptible animals (e.g., kittens less than to months of age). on the other hand, quarantine is warranted when a serious disease is discovered in a shelter population. if healthyappearing animals are exposed during a serious outbreak, quarantine procedures should be used to stop the movement of animals and prevent further spread of disease. if possible, temporary closure to admittance is also recommended. quarantine may also be required in bite cases to ensure compliance with state rabies laws. the particular population setting will guide the clinician's determination regarding implementation and length of quarantine, if any. a -day quarantine is sufficient to determine that cats are not incubating many common infectious diseases, including feline panleukopenia. however, other diseases, including feline leukemia virus and dermatophytosis, can have longer incubation periods and will therefore require a longer quarantine period. , in breeding colonies, early weaning and quarantine have been advocated to prevent infection of kittens with feline coronavirus. pregnant queens are isolated, and product selection should take into consideration the conditions present in a given environment (e.g., the type of surface and the presence of organic matter) and the compound's activity against the pathogens for which the animals are at greatest risk. the nonenveloped viruses, panleukopenia and feline calicivirus, are of particular concern. it is important to note that despite product label claims to the contrary, multiple independent studies have consistently shown that quaternary ammonium disinfectants do not reliably inactivate these important feline pathogens. , , in addition to selecting effective agents, ensuring adequate contact time followed by thorough drying of surfaces is essential for achieving proper disinfection. protocols should include detailed methods for achieving both cleaning and disinfection. when performed properly and regularly, these practices decrease both the dose and duration of exposure to infectious agents. box - outlines essential considerations for the development of cleaning and disinfection protocols. segregation refers to the separation of animals from the main group or into subpopulations as necessary to promote health. segregation of cats by physical and behavioral health status is essential for infectious disease control, stress reduction, and safety. in animal shelters, segregation may also be required to ensure compliance with animal control procedures as prescribed by state or local ordinances. depending on the setting, consideration should be given to separating cats by gender and reproductive status (e.g., intact, neutered, in heat, pregnant, nursing), physical and behavioral health status (e.g., apparently healthy, signs of contagious disease, reactive, feral), and life stage. a variety of separate areas will be necessary, depending on the needs of the given population and the context of the setting. the wellness program should define these areas in order to optimize cat health, while providing for the necessary functions of the facility. depending on the setting, consideration should be given to establishing areas for quarantine, isolation, general holding, adoption, and long-term housing, as well as to tailoring these by life stage. for example, the very young and very old typically require more specialized care than healthy juveniles and adults. kittens less than to months of age are particularly susceptible to infectious disease, and extra care must be taken to heighten biosecurity and limit their exposure. in particular, geriatric cats require comfortable, quiet quarters with careful attention to stress reduction (e.g., the provision of a secure hiding place and a dedicated caregiver to enhance bonding and comfort). if cats are used for breeding, functional areas will be required to facilitate mating, queening, and kitten care. and, as previously • staff must wear personal protective equipment, as necessary, to prevent exposure to chemicals and/or pathogens. • thorough cleaning and disinfection of enclosures should occur between occupants and as part of periodic deep cleaning procedures. • cats must be removed from enclosures during these procedures. • "spot cleaning" is generally sufficient for apparently healthy cats that will continue to occupy the same enclosure. • the cat remains in the enclosure while it is cleaned and soiled material is removed. • this method is often less stressful for cats (see figure - ). • separate staff should clean and care for animals in areas with highly susceptible or sick animals, whenever possible. • at minimum, attention should be given to the order of cleaning. • the least contaminated areas should be cleaned before those that are the most contaminated. kittens are weaned as early as possible (e.g., to weeks of age) and placed in strict quarantine. in this manner, as maternal antibody wanes and kittens become susceptible to the virus, exposure and infection are prevented. however, it is important to note that the level of biosecurity required for success is difficult to achieve. furthermore, eventual exposure and infection are highly likely because of the ubiquitous nature of coronaviruses. in addition, because of the importance of the mother-kitten relationship to normal social and emotional development, this management practice may not always be desirable. healthy environmental conditions in isolation areas promote recovery, and their importance cannot be overemphasized. crowding, noise, and stress must be avoided, and facilities must be easy to clean and disinfect. room temperature should be warm and comfortable with good air quality. windows are ideal, because natural sunlight is always beneficial to animal health and healing. strict biosecurity in quarantine and isolation areas, with attention to traffic patterns and the use of protective clothing, such as gowns and shoe covers, is essential. footbaths are insufficient to prevent transfer of infectious agents on shoes. this is because disinfectants typically require minutes of contact time and may be poorly effective in the presence of organic debris. in fact, footbaths may even contribute to the spread of disease. dedicated boots or shoe covers should be used when entering contaminated areas. , in addition, separate, designated staff should care for animals in high biosecurity areas whenever possible. by design, traffic patterns should move from the healthiest and most susceptible groupings to the least susceptible, and finally to isolation areas housing sick animals. observation windows and signage are useful to reduce traffic flow into high-risk areas. staff hygiene is extremely important, and the importance of diligent hand washing cannot be overemphasized. where space or facilities are not available, foster care may represent a viable and medically sound option for quarantine or isolation in some settings. for instance, in animal shelters, foster care is particularly useful for the care of preweaning-age kittens. foster homes must be monitored to ensure that cats receive proper care and that resident animals are protected from disease exposure. in addition to ensuring proper population density, segregation, and sanitation procedures, there are several other essential aspects of facility operations that must be incorporated into a population wellness program. these include heating, ventilation, and air conditioning (hvac) considerations, noise and pest control, general facility maintenance, and staff training. extremes or fluctuations in temperature and humidity, as well as poor ventilation and air quality, can compromise animal health. poor ventilation and high humidity favor the accumulation of infectious agents, while dust and fumes may be irritating to the respiratory tract. many cats are particularly sensitive to drafts and chilling, both of which can predispose to upper respiratory general holding, housing, adoption, and other areas in many settings, general holding areas are used for housing healthy juvenile and adult cats at intake. in animal shelters, it is important to consider that length of stay is associated with an increased risk of feline upper respiratory disease and that vaccination against core diseases often rapidly confers immunity. for these reasons, holding periods should be minimized whenever possible. in some cases, holding times will be influenced by legally required holding periods prescribed by state laws that allow owners a chance to reclaim lost pets. legal holding periods are usually not required for owner-relinquished pets and preweaning-age animals, but a brief medical hold (e.g., to days) for evaluation and triage is usually warranted. regardless, management practices that reduce length of stay are generally best for population health in a shelter setting. immunity is often strengthened with time through a combination of both active and passive immunity resulting from vaccination and exposure. upper respiratory disease is often endemic in cat populations, and in open populations, constant introduction of large numbers of carriers and susceptible cats make exposure likely. as length of stay increases, many cats develop and recover from respiratory disease. as animals acclimate to their environment and gain immunity, less stringent biosecurity requirements may be required for long-term housing areas, depending on the particular setting. in animal shelters, the public is usually allowed to interact with cats in adoption areas, which is another management consideration. isolation areas are used to segregate sick animals from the general population. immediate isolation of animals with signs of infectious disease is critical to effective control. isolation should be targeted by age and disease. for example, separate isolation areas should be available for cats and kittens with respiratory disease and those with gastrointestinal disease, whenever possible. in populations where upper respiratory infection is problematic, having two isolation areas for cats with respiratory infections is ideal: one area for those cats with moderate to severe signs that will require more intensive monitoring and treatment, and a separate area for those cats with only mild clinical signs and those that have been treated and are nearly recovered. when mildly symptomatic cats can be housed separately from those that are very ill, staff compliance with isolation procedures are often improved. cats with non-infectious conditions should also be housed in separate areas for treatment, and, in some cases, housing in the general population is appropriate. prevents exchange of air among them and is recommended, because air pressure gradients that recirculate or cause exchange of air between rooms have been associated with the spread of disease by aerosols. when applying these standard recommendations to a particular setting, there are some practical considerations that should be taken into account. first, even when ventilation systems provide to room air changes per hour, airflow may be restricted inside of cages or other enclosures within the room. in other words, the body of the room may be well ventilated, yet inside the cages, the air may remain relatively stagnant. in this case, ventilation may be improved by altering the housing design or arrangement; for example, the use of flow-through cages, runs, free-range rooms, or outdoor access may result in improved air quality. when considering the recommendations for % fresh, nonrecycled air with separate ventilation systems in various areas of the facility, consideration should be given to the fact that respiratory pathogens in cats are not aerosolized because of the cats' small tidal volume. although droplet transmission is possible, droplet spray does not extend more than feet, and most transmission of respiratory disease in cats is through direct contact with infected cats, carriers, or fomites. although this recommendation seems prudent to consider, especially for isolation areas, it is very expensive to install and operate this type of ventilation system throughout a facility, especially in very cold or very hot climates. if air quality remains good and the facility maintains effective comprehensive wellness protocols, it may not be necessary for animal health. more research is needed on the impact of such air exchange, but in the meantime, the author recommends consulting with an hvac specialist to establish effective and efficient settings to suit the specific needs of the given population. in addition to ensuring good ventilation, it is imperative to use other strategies for maintaining good air quality, including regular maintenance of filters, control of dust and dander through routine vacuuming and periodic deep cleaning, and the use of dust-free litter. noise control is another important consideration. it is crucial to keep cats out of auditory range of dogs, because many are profoundly stressed by the sounds of barking. also, staff should be trained to reduce or avoid other sources of noise whenever possible. the installation of sound-proofing systems may be necessary for noise abatement and stress reduction. routine pest control may also be required, depending on the setting. it may be necessary to treat the environment for fleas, ticks, or other insects or ectoparasites. products used to treat the environment must be selected carefully, because cats are extremely sensitive to the toxic effects of many insecticides. in many instances, it will infection. heating, ventilation, and air conditioning (hvac) specialists are uniquely qualified to help establish and maintain the environmental conditions required for animal health. when facilities are designed specifically for housing animals, these specialists should be consulted beforehand to ensure installation of the most effective and efficient systems possible. in reality, many facilities that house cats, including private catteries and shelters, among others, were not originally built for this purpose. retrofitting existing facilities with the ideal hvac system is often neither logistically nor financially feasible. regardless, consultation with hvac specialists is recommended in order to maximize the potential of the facility's existing system. the recommended temperature range for cats is between ° c and ° c ( ° f and ° f) with a temperature setting in the low-to mid- s celsius ( s fahrenheit) being typical. the temperature setting should be determined according to the specific animals' needs. for example, neonatal kittens are more susceptible to hypothermia and generally require warmer temperatures than healthy adult cats. the location of the cats may also be a consideration. for example, enclosures located closer to floor level are often a few degrees cooler than those at higher levels. the exact temperature setting may also vary somewhat based on the season of the year. for instance, power companies typically recommend keeping the temperature between ° c and ° c ( ° f and ° f) during hot weather to conserve electricity and reduce power bills. laboratory guidelines recommend % to % humidity for cats. higher humidity (e.g., %) may be advantageous in areas housing cats with respiratory disease because moist air may be beneficial to the respiratory passages, whereas lower humidity (e.g., % to %) may be beneficial in other areas in order to reduce survival of infectious agents in the environment. although the range considered acceptable is large, a given room should have a relatively constant humidity (i.e., it should not have large fluctuations). hosing or even mopping a room usually results in temporary spikes in humidity, but these will be short lived in a well-ventilated room. adequate ventilation is crucial for good air quality. this is especially important for cats, because good air quality is essential for control of upper respiratory disease. ten to fifteen air changes per hour is the standard recommendation for an animal room, but more or less airflow may be acceptable or necessary depending on the housing density. theoretically, the best case scenario, and what is typical in laboratory animal settings, is for the hvac system to allow for % fresh (e.g., nonrecycled) air in each room so that the air entering a given room is exhausted out of the building and not recirculated to another room. maintaining separate ventilation systems for various rooms or areas of a facility ensure both the physical and behavioral health of cats, as well as a healthy environment. a proactive, holistic approach coupled with compassion is required. when these are combined with careful attention to the unique needs and stress responses of cats, the result will be "healthy, happy cats." be necessary to remove cats during their application and only return them to the environment once it is thoroughly dried and ventilated. if rodent control is necessary, the use of rodenticide baits should be avoided, because cats can be exposed even if the bait is not within their reach. rodents that have ingested the poisonous bait may enter an animal enclosure and, if the animal ingests the rodent, the poison will affect that animal. humane live traps can be used to capture rodents for removal from a facility. food containers should be kept tightly sealed, and clutter should be minimized to discourage pests in the environment. general building maintenance procedures (e.g., regular inspection and servicing with repairs as needed) are also important considerations for the maintenance of a healthy environment. for example, periodic resealing of floors may be required as well as maintenance of plumbing fixtures to repair leaks or other problems. developing and following written standard operating procedures and daily, weekly, monthly, and quarterly checklists will ensure that systematic schedules of maintenance are carried out in a timely fashion. regular staff training is essential for implementing effective population wellness programs. simply stated, staff caring for animals must be qualified to do so. to a large extent, their knowledge and skill will determine the success or failure of the wellness program. embracing a culture of training promotes high-quality animal care as well as human safety. both formal and on-thejob training should be provided to ensure that a staff has the knowledge and skills required to perform their assigned tasks. protocols should be established for all levels of training, and a system should be in place to ensure proficiency. staff training should be documented, and continuing education should be provided to maintain and improve skills. finally, training must include the provision of information about zoonoses and 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pet dogs aafp-aaha. feline life stage guidelines meet your match and feline-ality adoption program key: cord- -duzoa v authors: sondermann, elena; ulbert, cornelia title: the threat of thinking in threats: reframing global health during and after covid- date: - - journal: z friedens und konflforsch doi: . /s - - - sha: doc_id: cord_uid: duzoa v narratives and metaphors shape how actors perceive the world around them and how policymakers frame the range of policy choices they think of as feasible. the metaphor of war and the narrative of how to tackle the unprecedented threat of covid- are effective mechanisms to convey urgency. however, they also bear serious implications: thinking in terms of health threats works with a logic of exceptionalism, which supports images of “us” vs. an “enemy” thereby shortening complex lines of causality and responsibility and privileging national answers. it fails to provide for a normative framework for drafting long-term systemic approaches. in this contribution, we critically engage with existing narratives of global health security and show how the logic of exceptionalism is limiting the current responses to the pandemic. we conceptualize an alternative narrative that is based on the logic of solidarity and argue that within this alternative framing a more sustainable and ultimately more just way of coping with infectious diseases will be possible. political speeches, media reporting and public debates are replete with notions of "the battle against corona", a "(global) war" (e.g. harari ) and the fight against the "hidden enemy" (white house a) or "invisible killer" (prime minister's office ). the narratives of war and the way to fight the covid- -enemy conveys urgency and prioritizes emergency measures. moreover, they imply the hope of a "win", thus an endpoint, as well as the idea that control and action are possible if all rally and pull together. all these notions seem obvious, smart and even necessary in the face of the worst infectious disease the world has experienced since the spanish flu of , which infected about one-third (around million people) (who ) of the world's population at that time throughout three waves that lasted until , taking up to millions of lives (taubenberger et al. , p. ) and rendering many more seriously ill or exposed to serious health risks. yet, these images and stories have other effects, too. thinking in a war on disease frame creates images of "us" vs. "it" as a unified "we" against an outside, suddenly emerging threat. it silences differences within societies and nations, shortens lines of causality and entanglement and blurs responsibility. the sense of exceptionalism that is conveyed with this narrative easily links with a framing of health as an issue of security. consequently, reactions are based on an emergency mode, thus preventing to act with a view to long-term systemic approaches. we base our following discussion on the constructivist premise that the political implications of events are not simply there to be "discovered" and "told" but lie in the interpretations of (political) actors (e.g. krebs , p. ) . framing is "understood as the presentation of an issue in such a way as to tie it into a broader set of ideas about the world" roemer-mahler , p. ) . thereby, frames give meaning to events and processes by highlighting some aspects and silencing others. at the same time, frames usually comprise dominant logics of actions that pave the way for how a perceived problem will be tackled. framing often resorts to narratives which can be analyzed along three dimensions (spencer , p. - ) . setting refers to the broader context and background of the story providing associations and possible connotations for the audience. characterization introduces protagonists and their quality and roles (i.e. hero or villain) in the story. lastly, emplotment weaves them together by tying them to a causal origin, logical sequence of acts and probable consequences for action. for our discussion, we will use these categories for the analysis and differentiation of narratives. firstly, we lay out the setting, i.e. the context for the framing of covid- as "security threat" referring to previous framings of health as security, i.e. health securitization (sect. ). we then introduce the "covid- as security threat" frame as "villain" (characterization) and show how this leads to a narrowing of the debate and political answers (emplotment) (sect. ). in a final move, we present an alternative narrative that is not based on the logic of exceptionalism but on the logic of solidarity (sect. ), and argue that within this alternative framing a more sustainable and ultimately more just way of coping with infectious diseases will be possible. finally, we summarize the differing narratives of global health and the implications of their logics of action (sect. ). health, illness and disease have always been object to framing processes: as health historians have long been drawing attention to, "disease" is not only a physical experience of illness but it is always also a social phenomenon as it represents the result of cultural sense-making and framing (e.g. rosenberg ) . throughout the last three decades health issues have been increasingly framed as security concerns (e.g. brown and harman ) . this was part of an overall development to move the concept of security beyond traditional inter-state conflicts and the notion of threat beyond military threats to include new security challenges. driven by the emergence of the novel hiv/aids disease and followed by sars, mers, ebola and zika the "threat of diseases" was pushed up high on the international agenda (rushton ) . infectious diseases have been debated in the un general assembly on numerous occasions and hiv/aids and ebola have been addressed by un security council resolutions as threats to national stability as well as national and international security (mcinnes and rushton ) . attention given to infectious diseases was intricately linked to and supported by the increased perception of health threats due to globalization and the associated, ever increasing speed of travel, transport and, relatedly, spread of pathogens. this framing of health issues as threats evoked connotations of something "out of the ordinary", an exceptional danger to lives or countries' stability, economies and trade. in light of this setting or broader context, the next sections discuss two variants of health narratives which entail different interpretations of the setting and, accordingly, competing characterizations and emplotments. two competing narratives of health security gained ground at the turn of the century. already in their characterization of the main protagonists they differ: a state-centric perspective of health security equating health issues to other threats to nation states and an alternative narrative of health security referring to individuals as the object of security (i.e. security for whom?). health security from this latter perspective formed an integral part of the human security concept introduced by the united nations development programme (undp) in the mid- s (undp ) . while both narratives, what sara davies ( ) has labelled a "statist" ( ) and a "globalist" perspective ( ), refer to health security, they tell very different stories about whom to protect (states ( ) vs. individuals ( )) and what to protect them from (mainly infectious diseases ( ) vs. range of communicable and non-communicable diseases: "illness, disability and avoidable death" (commission on human security , p. ) ( )). the second understanding characterizes, the "threat to human security" not as stemming from the "outside". rather, it views health threats as a direct result from structures of poverty and inequality i.e. in the form of health system access. external threats might be neither preventable nor controllable, hence changeable. yet, internal structures certainly are. thus, the role and responsibility of the state is portrayed very differently. in the first variant of the health security narrative states are assigned the role of insurers or rescuers of health security, while in the second variant they become part of the problem ("the villain"), if they wait until the threats to human health security materialize. it also entails an active and larger role for international organizations (ios) and non-state actors. regarding health policies, the globalist narrative leads to a stronger focus on strengthening health systems and ensuring equal access. here, the idea of security has been stretched far, translating it to "freedom from want" and "freedom from fear". nonetheless, both narratives still characterize states as main protagonists, albeit with substantially different roles. through the linkage of health to "security against threats" the narrative of health security operates with a logic of exceptionalism: (external, also distant) health issues (i.e. infectious diseases) are perceived as positing severe or extraordinary danger to the physical well-being of individuals or entire societies, a threat to the normal (economic, cultural, financial) way of life in a country. this is framed as cause for political reactions in the form of emergency measures. due to their linkage of health to security they always remain defensive. their main frame is "ensuring health against a threat". to date the narrow conceptualization of securing against infectious diseases dominates the mainstream policy agenda (see fig. ). the threat of thinking in threats: reframing global health during and after covid- yet, the core controversy lies in the questions of protecting whom, from what and at what cost. we address four implications and limitations of the narrative, which challenge its simplistic characterizations and emplotments and prepare our discussions for the subsequent parts. first, we contend that exceptionalism itself means substantially different things to different actors. to countries of the global north, the threats were exceptional in the sense of "new" as they realized their own, increased vulnerability and feared that for the first time in decades, "colonial problems" might reach across their borders and endanger their societies. however, in contrast to some countries of the global south, to which infectious diseases are well known and even systemic, the health emergencies only very rarely threatened the security of countries of the global north and their societies directly in the form of taking people's lives. second, the logic of exceptionalism is performative and leads to a range of reactive policy options, which revolve around the object of fear, i.e. the threat. they are neither concerned with addressing root causes of the emergence of diseases nor with structural factors promoting vulnerability to exposure or the ability to cope. third, by centering on the object to secure and the external threat, neither the relations between objects of security nor their positional differences in relation to the threat are integral to the concept. this is true even for a more collective understanding of global health security as promoted by the world health organization (who) since the early s (who ) . given the significant differences of countries regarding their exposure to, history of and coping capacities for infectious diseases "global health security" cannot mean the same for all countries. it also takes an unequal toll on countries. emergency response measures, such as lock-down, closing the border and suspension of free flow of goods and services are mainly imposed on countries experiencing the disease, i.e.-before covid- -countries of the global south. hence, we argue that the manifold roles and responsibilities for realizing health security remain hidden as well as the diverging extent of the threat or costs for prevention and containment. lastly, exception per se means a deviation from the norm. even though prevention and surveillance mechanisms can be thought of as longer-term governance practices, the anchoring concept of the health security governance regime is not. threat in its nature is never a "normal" condition but works with individual and collective shorterterm notions of danger and fear. thus, the global health security narrative does not entail a logic of action, which rests on normative, longer-term perspectives. the narrative of exceptional global threats to national and international stability has certainly fostered attention and resources (wenham (wenham , p. , at least for some time. yet, the "'global' rhetoric" (rushton , p. ) has not replaced traditional ideas of national and international health security. instead, we contend that while the "global" in global health signaled a new awareness of shared "threats" and "risks" (kirk ; mcinnes and roemer-mahler ) , the nation state, i.e. "our national health" has remained the reference object. this narrative of securing against infectious diseases is inherent to mainstream framing of health security and has provided the context and repertoire for emplotment regarding the coronavirus pandemic. since the who declared covid- a pandemic on march , , the subsequent narratives have been replete with notions of "existential threat", "war" and "invisible enemy". they are deeply entrenched in narratives of health security (setting). the protagonists are clear: "we" against an identifiable, outside threat, an "object of fear", i.e. the coronavirus. yet, the more specific characterization of "we", the reference object, was conceived of differently. while io leaders, namely united nations (un) secretary-general, antónio guterres, referred to a "common enemy" and an "enemy of humanity" or to the "citizens of the world" (un secretary-general ; emphasis added), many political leaders were quick to jump to a narrative of national security and national emergency (benziman ) . the emplotment, thus the framing of the consequences for action, also diverged. leaders of ios promoted "international cooperation between governments and global coordination of policy responses" and cautioned that "all countries must strike a fine balance between protecting health, minimizing economic and social disruption, and respecting human rights" (who director-general ). at the same time, u.s. president donald j. trump saw the united states "at war" and himself as a "wartime president" (white house b). by describing covid- as the "chinese virus" or "wuhan virus", he framed the health emergency as a traditional security issue and another country as a source of that threat. while these framings arguably constitute extremes of a continuum and can only be partly explained by the different roles and audiences of the speakers, it is striking how they all work with the image of an existential threat (albeit to a different "who"). this triggered the logic of exceptionalism inherent in the "health as security" narrative. the high transmission rate of the coronavirus and the severity of the covid- disease seem reason enough to resort to the logic of exceptionalism. however, the response to a disease always not only reflects the characteristics of the pathogen but also depends on the narration of the disease. covid- is a global pandemic and this universal experience and perceived "sameness" marks the crucial difference from any epidemic of the post-war his-k tory (sondermann ). yet, one could also challenge this notion by emphasizing that there have been pandemics in the recent past, however, not in industrialized countries. for some, the pandemic is thus more exceptional than for others. not surprisingly, experiences, best practices and advice of countries of the global south which had suffered from ebola, cholera, hiv/aids or zika were largely being ignored (harman ) . the narrative of the "exceptional threat to our live" has legitimized unprecedented political measures of physical distancing and lock-down all around the globe. they have disrupted not only the everyday lives of people worldwide but put to a halt all political, cultural and economic processes, both nationally and internationally. following benziman ( ) we argue that thinking in threats entails known categories of "us" vs "it", an identifiable, outside threat, an "object of fear". it presents the pandemic as something unforeseeable and "not our fault" (harman ) and leads to a focus on reactive emergency measures, renewed agency and transmits a sense of control (emplotment). this shift to the executive has then led to a perpetuated cycle of securitizing health. this implies a narrow framing, which overlooks the health issues that actually account for the health matter at hand, namely health systems and access to health. while corona is a global health crisis it has been met in national understandings and corresponding national responses. these were mostly exclusively focused on protecting own citizens or framed as enhancing national interests. moreover, the costs of the pandemic and containment measures differ significantly and will continue to do so. emergency measures bear the risk of diminished civil rights accompanied by an increase in conflicts and humanitarian crises. furthermore, other severe health crises loom as aid resources are redirected and vaccinations drop. all in all, inequalities between and within societies have manifested. the outbreak of a coronavirus pandemic was neither unexpected nor unanticipated. instead, scenarios had been developed to envision and prepare for exactly such a pandemic. yet, years of political and academic attention to the health-security nexus had neither prevented existing institutions for surveillance and control from being cut or diminished in recent years, nor did they appear to have succeeded in equipping the world's countries for dealing with a global pandemic. therefore, we propose a reframing of health, which grapples with the complexity of global health as an intersectional issue and right of individuals. as we have seen earlier, similar ideas have been championed for decades. we are convinced that the current moment in time has opened a unique window of opportunity to overcome a narrow framing of health security. the current pandemic has shed light on the weaknesses of the idea of exceptionalism and the logic of action it entails. thus, a change of setting, protagonists and overall storyline is needed to open up new courses of action. it is highly likely that in the future humankind will have to cope with more incidents of infectious diseases transgressing borders and spreading globally (bloom et al. k e. sondermann, c. ulbert ). this is not only due to the increasing mobility of goods and people, but also to our way of production and consumption that leads to environmental changes like climate change, land degradation or biodiversity loss. although experts have been aware of these threats, which have been at the center especially of the human security agenda for some time, governments and societies still seem to be unprepared for the challenges that lie ahead. we would argue that this is also a result of the dominant narrative of health security and its lack of basing its dominant logic of action on a normative framework that opens up a long-term systemic perspective without losing sight of individuals as bearers of duties and rights. therefore, we suggest an alternative narrative of global health that does not rest on a logic of exceptionalism but on the logic of solidarity (see fig. ). solidarity as an ethical principle has been discussed for some time in global health (e.g. harmon ) and is explicitly discussed with view to the covid- pandemic (de campos ). in fact, frenk, gómez-dantés and moon argued, that the existing concept of global health is not able "to capture the essence of globalization" (frenk et al. , p. ) , and suggested to reframe it as "health of the global population" and "product of health interdependence" (frenk et al. , p. ) , thereby using the term solidarity "to refer to situations of interdependence created by the complex division of roles characteristic of modern societies" (frenk et al. , p. ) . in political terms, solidarity relates to "individuals performing reciprocal duties and respecting reciprocal rights" (harmon , p. ) . from this k definition, harmon derives several propositions of what solidarity comprises: the recognition that individuals are embedded in social contexts, the focus on the wellbeing of others thus emphasizing equality and the promotion of welfare, and the demand for common action (harmon , p. ) . another defining feature of solidarity is that the distinction between "we" and "them" is suspended, since solidarity is exercised within a symmetrical relationship characterized by equality. usually this works quite well within groups. but what about solidarity between groups, especially those which are geographically more distant? with respect to global health, the common experience of vulnerability may act as source of solidarity (west-oram and buyx , p. - ) . from this perspective, solidarity can be understood "as enacted practices that are based on concrete recognition of similarity in a given specific context" (west-oram and buyx , p. ; emphasis in the original). vulnerability is a crucial factor for how individuals and societies cope with risks. the current covid- pandemic, however, teaches us that societies across the globe are facing shared vulnerabilities (gostin ) since our economies and many aspects of our lifestyles have become so interdependent as the example of global tourism shows. historically, it used to be the case that the wealthier people in the global north had the privilege of ever-growing safety from infectious diseases with which people in the global south still had to cope. however, even if countries of the global north may still have more resources available to cope with newly emerging health threats like covid- , the degree of vulnerability they are encountering has considerably increased (west-oram and buyx , p. ) . therefore, the alternative narrative of global health we propose does not start from health threats and emergencies but sketches a different setting of shared vulnerabilities and interdependence from which to proceed. taking vulnerabilities as the starting point, will also lead to a different characterization of the main protagonists. the covid- pandemic permeates all borders and affects all countries. yet, it has unequal effects on livelihoods across all societies. overcoming dichotomies of "we" and "them" and thinking instead in terms of vulnerabilities pays tribute to the inequalities people around the globe suffer. focusing on inequality and justice puts individuals at the center who have a right to health and who also have the agency to realize it as duty bearers and rights holders. although states, which ultimately are the stewards of securing human rights for their citizens, are not the main protagonists anymore, they still have a crucial role to play, but in conjunction with ios, private and civil-society actors. they all share the responsibility-albeit in a differentiated way-to provide health as a global public good. consequently, from a perspective of countries of the global north, infectious diseases should not be looked upon as diseases originating in countries of the global south that have to be contained. instead, the emplotment of the narrative leads to a different causal origin of the problem societies and individuals are facing: the social determinants of health have long been acknowledged (commission on social determinants of health ) and the imperative of "health equity" that it implies. thus, health inequities are seen as causes of vulnerabilities. at the same time, the awareness of the global nature of the pandemic leads to calls for collective and multilateral action on the one hand and to overcoming traditional perceptions and categories of countries-in-need on the other. ultimately, health as a global public good can only be attained by "building more robust global institutions for pooling risks, resources, and responsibilities among sovereign states-and in many cases, also non-state actors" (frenk et al. , p. ) . the current push for a vaccine against the sars-cov- virus will lead to quite different results if framed in terms of national security or in terms of global solidarity, which the who and the united nations have been advocating constantly. humankind will only overcome the current and future pandemics if health is not regarded as an instrument for achieving security or economic development, but as a human right, a value in its own right and goal of policies. we began this contribution with the premise that narratives shape how people perceive the world around them and condition how political actors are framing policy choices to cope with challenges. from the onset, the current coronavirus pandemic has been embedded in a narrative of global health security. consequently, it has been framed as an exceptional threat that had to be countered with a range of farreaching emergency measures. although the narrative of global health security is characterized by two distinct variants, with the concept of human security opening up the space to think of how individuals and their rights are affected by inequalities, both variants are firmly rooted in depicting health threats as exceptional and existential to our lives. covid- is a prime example of how the logic of exceptionalism is shaping and limiting the k the threat of thinking in threats: reframing global health during and after responses to it: the range of policy choices is still primarily focused on emergency measures (see fig. ). the current pandemic, however, provides the opportunity to think in terms of shared vulnerabilities as context for tackling the disease. these vulnerabilities are not only due to changing global health threats. they are also caused by social and environmental determinants of health. the more the consequences of climate change, for example, are felt all over the world, the more, even countries of the global north, realize how hard it will be for them to adapt to it. we have argued that the awareness of shared vulnerabilities allows for a logic of solidarity to be set in motion. reframing the narrative of global health from security to solidarity with the aim of providing global public goods for health will change the "rules of the game": only then the intersectional and interdependent nature of health as a product of its social determinants and ecological environment will translate into political action guided by a long-term systems approach based on prevention, surveillance and health systems strengthening to enhance the resilience of communities. funding open access funding enabled and organized by projekt deal. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creativecommons.org/licenses/by/ . /. winning" the "battle" and "beating" the covid- "enemy". leaders' use of war frames to define the pandemic. peace and conflict emerging infectious diseases. a proactive approach 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(covid- ) disease in history. frames and framers global health security. security for whom? security from what? secretary-general's appeal for global ceasefire die pandemie muss ganzheitlich bekämpft werden. investitionen in gesundheitssysteme für widerstandsfähige gesellschaften (frient-blog romantic narratives in international politics. manchester: pirates, rebels and mercenaries the influenza pandemic. years of questions answered and unanswered the oversecuritization of global health. changing the terms of debate proclamation on national doctors day remarks by president trump, vice president pence, and members of the coronavirus task force in press briefing the world health report . a safer future: global public health security in the st century spotlight: influenza-are we ready? key: cord- -geboovve authors: xu, yeqing; shao, yang; huang, jingjing title: mental health services in shanghai during the covid- outbreak date: - - journal: nan doi: . /j.fsiml. . sha: doc_id: cord_uid: geboovve nan the outbreak of coronavirus disease (covid- ) emerged in china and has now spread to nearly every country in the world. the world health organization declared on march that the spread of covid- has become a pandemic. as of may th , people had been diagnosed with novel coronavirus (including imported cases) in shanghai (shanghai municipal health commission, a) . shanghai is the most populous urban area in china with a population of . million. although the cases are less than one in , of the population, people who live in shanghai were asked to avoid public places since late january. shanghai is at high risk of carriers of the covid- virus entering the city because of the large population of migrant workers. having more time at home triggered a wide variety of psychological problems (qiu et al., ) . at the very beginning of the epidemic, experts from shanghai mental health center (smhc), the top-class psychiatric institution in china, were aware that this would be a challenging time for our mental health professionals. psychological services were urgently needed to help ease the nerves amid the coronavirus epidemic both for the public and the medical workers battling the coronavirus. furthermore, adequate and necessary attention was required for patients with mental health disorders in the covid- epidemic (yao, chen & xu, ) . to avoid a coronavirus outbreak in psychiatric hospitals, only people with green health qr color can enter. (the health qr code, which is available on the suishenban app or through wechat and ali pay, has three colors -green for the healthy people, yellow for people returning from countries and regions heavily affected by coronavirus sand who are under quarantine, and red for confirmed or suspected patients still under medical observation. the code is updated when people's conditions change.) inpatient psychiatric facilities are facing a high risk from the rapid spread of covid- . to achieve the goal of zero infection, new rules were made for the inpatient admission process (national health commission, ) . before admission, psychiatrists should make sure every patient has been ruled out of having novel coronavirus pneumonia (ncp). patients with high body temperature or with suspicious circumstances found through epidemiological investigation (for example close contact with confirmed or suspected cases) should be sent to designated fever clinics for further examination with our psychiatrists accompanying in case psychiatric consultation was needed there. if the test results are negative, patients will be taken back and admitted to psychiatric inpatient ward. if the test results are positive, patients will be transferred to shanghai public health clinical center for further treatment (one to four psychiatrists are working there during the epidemic, offering psychiatric consultations for patients and psychological services for medics). all staff in the psychiatric hospital are asked not to leave shanghai during the epidemic and should report their health conditions every day. inpatients' family members are persuaded to make phone calls instead of face-to-face visits. video chat is allowed under exceptional circumstances (for example, an elderly woman who lives in another province worried very much about her -year old daughter who was admitted before the epidemic. to relieve her anxiety, the nurse arranged a video chat for them). most treatments are provided in inpatient department as normal except for group therapy. routine outpatient services are provided but all patients should wear face masks, take body temperature test and undergo epidemiological investigation before they walk into the outpatient clinic buildings. if a patient was believed to be suspicious, they would be taken to see a psychiatrist wearing personal protective equipment in a clinic room outside the buildings to make sure they would be separated from other patients. the patient would also be registered and recommended to go to designated fever clinics. impractical due to the nationwide regulations on travel and quarantine (yao, chen & xu, ) . therefore, non-contact services are urgently needed. online hospitals got the green light for insurance payments amid the fight of ncp. smhc is about to become the first online psychiatric hospital in shanghai. although free online counselling was offered at the very beginning of the epidemic, patients still have difficulties in getting a refill of their medicines. once the online hospital license has been issued by the local health commission, online prescriptions will be covered by the local medical insurance system and the drugs will be delivered to patients' homes. the coronavirus epidemic also affected the provision of mental health services in the judicial correction system. the above preventive measures for inpatient service are also applicable to the ankang hospital, the only secure psychiatry hospital in shanghai for patients who were assessed as not having criminal responsibility because of mental illness. for prisoners with serious mental problems, outpatient services still exist. they may go to these clinics after obtaining the approval of the prison director, but adequate protection is required. after returning to prison, the accompanying prison guards and the prisoner must have a -day quarantine (chinese center for disease control and prevention, ). all these strict measures help us to make sure there is no coronavirus infection in psychiatric hospitals, but also makes the access to mental health services more difficult. accordingly, remote psychological services are provided for fighting the epidemic including online or hotline counseling services amid efforts to prevent and control the epidemic. free online resources and interventions could benefit population mental health (gunnell d et al. ). the shanghai psychological assistance hotline was launched to provide free counseling for more than twenty years. during the epidemic period, the daily number of calls is up about percent compared with before the outbreak of novel coronavirus. a new line has been opened especially for the epidemic both in chinese and english. free online lectures are also offered by experts from smhc and other mental health centers in shanghai to advise people how to deal with negative emotions during the epidemic. video chat were held with overseas chinese and students, answering their questions on battling coronavirus. the official wechat account of smhc is regularly releasing coronavirus-related content. people can use the wechat account to make an outpatient appointment as well. psychological support is very important both for ncp patient and medics. frontline medical staff are under enormous mental pressures due to overwork and the high risks of infection from their exposure . mental health services are offered to patients and medics both in shanghai and in wuhan. psychiatrists and psychologists have been working as part of a multi-disciplinary team at shanghai public health clinical center since january. their daily work is to offer psychiatric consultations for ncp patients with anxiety, depression or other mental health conditions. they also provide psychological counselling and help arrange a balint group for staff. a medical team with psychiatrists were sent to the wuhan hubei province to join other doctors from shanghai fighting against covid- for nearly two months. all the medics back from wuhan had returned to their own hospitals in shanghai after a -day quarantine in april. mental health care for medical staff in china during the covid- outbreak technical plan for covid- prevention and control in prison suicide risk and prevention during the covid- pandemic a circular on the prevention and control of covid- in accordance with the law and in a scientific and accurate manner a nationwide survey of psychological distress among chinese people in the covid- epidemic: implications and policy recommendations shanghai municipal health commission. ( a) press release on the city's covid- response shanghai medical experts video-chat with overseas chinese on covid- patients with mental health disorders in the covid- epidemic shanghai is now under greater pressure to contain imported cases of infection (shanghai municipal health commission, b). all the strict measures to fight coronavirus will remain in place. xie bin, a psychologist with the shanghai mental health center, said "everyone is on the same train heading toward the final stop of the pandemic. please sit tight and have faith in the 'train crew' -medics and experts worldwide, who will drive the train safely to the destination." (xinhuanet, ) the authors have no conflicts of interest to declare. key: cord- -giku r authors: manrique-saide, pablo; dean, natalie e.; halloran, m. elizabeth; longini, ira m.; collins, matthew h.; waller, lance a.; gomez-dantes, hector; lenhart, audrey; hladish, thomas j.; che-mendoza, azael; kirstein, oscar d.; romer, yamila; correa-morales, fabian; palacio-vargas, jorge; mendez-vales, rosa; pérez, pilar granja; pavia-ruz, norma; ayora-talavera, guadalupe; vazquez-prokopec, gonzalo m. title: the tirs trial: protocol for a cluster randomized controlled trial assessing the efficacy of preventive targeted indoor residual spraying to reduce aedes-borne viral illnesses in merida, mexico date: - - journal: trials doi: . /s - - - sha: doc_id: cord_uid: giku r background: current urban vector control strategies have failed to contain dengue epidemics and to prevent the global expansion of aedes-borne viruses (abvs: dengue, chikungunya, zika). part of the challenge in sustaining effective abv control emerges from the paucity of evidence regarding the epidemiological impact of any aedes control method. a strategy for which there is limited epidemiological evidence is targeted indoor residual spraying (tirs). tirs is a modification of classic malaria indoor residual spraying that accounts for aedes aegypti resting behavior by applying residual insecticides on exposed lower sections of walls (< . m), under furniture, and on dark surfaces. methods/design: we are pursuing a two-arm, parallel, unblinded, cluster randomized controlled trial to quantify the overall efficacy of tirs in reducing the burden of laboratory-confirmed abv clinical disease (primary endpoint). the trial will be conducted in the city of merida, yucatan state, mexico (population ~ million), where we will prospectively follow children aged – years at enrollment, distributed in clusters of × city blocks each. clusters will be randomly allocated (n = per arm) using covariate-constrained randomization. a “fried egg” design will be followed, in which all blocks of the × cluster receive the intervention, but all sampling to evaluate the epidemiological and entomological endpoints will occur in the “yolk,” the center × city blocks of each cluster. tirs will be implemented as a preventive application (~ – months prior to the beginning of the abv season). active monitoring for symptomatic abv illness will occur through weekly household visits and enhanced surveillance. annual sero-surveys will be performed after each transmission season and entomological evaluations of ae. aegypti indoor abundance and abv infection rates monthly during the period of active surveillance. epidemiological and entomological evaluation will continue for up to three transmission seasons. discussion: the findings from this study will provide robust epidemiological evidence of the efficacy of tirs in reducing abv illness and infection. if efficacious, tirs could drive a paradigm shift in aedes control by considering ae. aegypti behavior to guide residual insecticide applications and changing deployment to preemptive control (rather than in response to symptomatic cases), two major enhancements to existing practice. trial registration: clinicaltrials.gov nct . registered on april . the protocol also complies with the who international clinical trials registry platform (ictrp) (additional file ). primary sponsor: national institutes of health, national institute of allergy and infectious diseases (nih/niaid). aedes-borne viruses (abvs; e.g., dengue [denv] , chikungunya [chikv] , zika [zikv]) pose a major public health burden worldwide [ ] [ ] [ ] . transmitted primarily by the highly anthropophilic mosquito aedes aegypti, abvs propagate epidemically, inflicting substantial healthcare and development costs on urban tropical populations. model projections estimate that an average of million denv infections occur per year, of which million manifest clinically [ , ] . explosive denv outbreaks saturate healthcare systems [ ] , with worldwide estimates as high as $ billion ( us$) per year spent on costs related to medical care, surveillance, vector control, and lost productivity [ ] . the emergence and rapid epidemic propagation of chikv and zikv (and particularly congenital zika) have added significant burden and costs to healthcare systems [ , ] . given the heavy global burden of abv illness, and in the absence of efficacious vaccines or other therapeutic options, implementation of highly effective and currently available vector control strategies represents the most viable approach for abv prevention [ , ] . vector control methods such as larval control, source reduction, and space spraying are widely used against abvs [ , ] . unfortunately, there is limited epidemiological evidence that these methods are adequate to prevent or reduce human abv transmission in a sustainable manner [ , ] . poorly designed evaluations, a historical lack of focus on quantifying intervention impact using epidemiological endpoints, and limited funding for large-scale randomized controlled trials with epidemiological endpoints have all contributed to the lack of rigorous, evidence-based, assessments of abv vector control interventions [ , ] . furthermore, the classic deployment of house-based interventions in response to reported clinical abv cases has failed to account for the important contribution of out-of-home human exposure to ae. aegypti [ ] and the silent contribution of asymptomatic infections in sustaining infectious virus in local mosquitoes [ ] . novel vector control approaches and intervention delivery strategies with proven and robust epidemiological evidence of their impact on abv transmission are urgently needed. indoor residual spraying (irs) is the use of longlasting residual insecticides applied to the walls, eaves, and ceilings of houses or structures targeting vectors that land or rest on these surfaces [ ] [ ] [ ] . the residual component of the application means that, for several weeks or months, the insecticide will kill mosquitoes and other insects that come into contact with treated surfaces. historical evidence has shown that, when expeditiously implemented, residual insecticide applications can significantly reduce abv transmission [ ] [ ] [ ] . despite this evidence, the fact that it is time consuming and dependent on specialized human resources has limited widespread adoption of irs by abv control programs due to the perceived challenge of scaling-up the intervention over large urban areas. in urban settings, adult ae. aegypti typically rest indoors, where they feed frequently and almost exclusively on human blood [ ] . studies performed in panama, peru, and mexico have shown that ae. aegypti rest predominantly below heights of . m, mainly inside bedrooms and on surfaces made of cement, wood, and cloth [ ] [ ] [ ] . selectively applying residual insecticides below . m and on common mosquito resting surfaces provides an entomological impact similar to spraying entire walls (as performed in classic irs), but in a fraction of the time (< %) and insecticide volume (< %) compared to classic irs [ ] . this selective insecticide application mode is called "targeted indoor residual spraying" (tirs), and it involves the application of residual insecticides on exposed lower sections of walls [< . m], under furniture, and on dark surfaces throughout houses with the exception of the kitchen (fig. ). as such, tirs is a rational vector control approach whereby ae. aegypti resting behavior guides targeted insecticide applications, thus reducing unnecessary exposure to chemicals for both applicators and household residents (fig. ) , and also reducing the time it takes to spray a premise with no apparent loss in insecticidal efficacy [ ] . in cairns, australia, an observational study found that tirs can reduce the probability of future denv transmission by - % as compared to unsprayed premises [ ] . concurrent trap collections of ae. aegypti in the heart of the outbreak showed that tirs was associated with a~ % reduction in gravid ae. aegypti female abundance [ ] . in merida, mexico, a phase ii cluster randomized controlled trial (crct) evaluated the entomological impact of irs with bendiocarb (ficam®, bayer, a carbamate insecticide to which local ae. aegypti are fully susceptible) and reported reductions in indoor adult ae. aegypti abundance up to % over a -month period, compared to no reduction when the pyrethroid deltamethrin was used [ ] . fitting such entomological information to an agent-based model of yucatan state, mexico, showed that high levels of tirs coverage ( % of houses treated once per year) applied preemptively before the typical dengue season (before july) could reduce denv infections by . % in year and . % cumulatively over the first years of an annual program [ ] . such findings were confirmed with another modeling study comparing tirs with indoor space spraying in iquitos, peru [ ] . these findings suggest that preemptive tirs may provide high short-term and long-term effectiveness in preventing abvs in endemic areas where transmission is seasonal. a systematic review has identified tirs as a highly promising approach for abv prevention [ ] , but highlighted the limited evidence for tirs due to the absence of impact estimates from randomized controlled trials with epidemiological endpoints performed in endemic settings. the study protocol presented here introduces the design for a crct to test whether tirs, applied preventively, reduces laboratory-confirmed cases of abv illness and infection in the city of merida, yucatan state, mexico. trial endpoints are listed in table and the approaches followed to quantify them will be described in subsequent sections. merida, the capital city of yucatan state, is the largest urban center in the region with , inhabitants [ ] . the city has a tropical climate characterized by a mean annual temperature of . °c and an annual fig. targeted indoor residual spraying (tirs) to control ae. aegypti. in urban environments, houses are primarily built of brick and cement, and ae. aegypti rests preferentially below . m of height. spraying residual insecticides in walls below . m and in key resting sites such as under furniture (# in figure, represented in green) will eventually kill ae. aegypti that may be emerging from immature larval habitats outdoors ( ) and rest indoors on treated surfaces ( ) . after exposure to the residual insecticide, mortality can occur immediately ( ) or after several hours/days ( ) precipitation of mm. merida is endemic for abvs, with denv being persistently transmitted since and, more recently, co-circulating with chikv (since ) and zikv (since ) [ , ] . abv transmission in merida is seasonal, beginning in july and peaking in october-november. baseline serological information (captured by elisa methods) on natural abv infection rates has been collected from merida in - through a school-based cohort that followed all family members living in the same household as the enrolled children [ ] [ ] [ ] . in , denv seroprevalence in the cohort was . %, which increased with age from % in - -year-olds to % in adults ≥ years. in - , the incidence of lab-confirmed abv illness in the cohort was . per person-years ( % ci . , . ) [ ] . the incidence of symptomatic dengue infections observed during the same period was . cases per person-years ( % ci . , . ). the majority of seroconversions occurred in the younger age groups (≤ years old) [ ] [ ] [ ] . the incidence of symptomatic chikungunya illness was . per person-years ( % ci . , . ) and the incidence rate of symptomatic zika illness was . per person-years ( % ci . , . ) [ ] . zika virus symptomatic attack rate in pregnant women from the cohort was % [ ] . data from~ , geocoded denv, zikv and chikv symptomatic cases captured by mexico's national passive surveillance system from to identified denv transmission "hot-spots" in merida (areas with higher-than-average numbers of cases), which overlapped with chikv and zikv hot-spots [ ] . combining these data with information from the cohort, we found that denv seroprevalence rates are~ × higher in hot-spot areas compared to other areas [ ] . merida also has entomological laboratory infrastructure and trained personnel to conduct and evaluate tirs [ , ] . the collaborative unit for entomological bioassays (ucbe) is a reference laboratory within the autonomous university of yucatan (uady) and is currently a world health organization good laboratory practice (glp) site for evaluating insecticide products for vector control [ ] . the two-arm crct will include a total of clusters of × city blocks each, with clusters randomly allocated to the intervention (tirs) arm and clusters allocated to the control arm (fig. ) . routine ministry of health (moh) vector control actions performed in response to symptomatic abv cases reported to the healthcare system will not be interrupted and could occur across both study arms. upon detection of a suspected abv case in the national epidemiological database, yucatan moh mobilizes its staff aiming at containing local transmission by focusing efforts on adult mosquito control. truck-mounted ulv spraying with the organophosphate insecticides chlorpyrifos and malathion is widely implemented in merida, despite scientific evidence of its poor efficacy [ ] . moh response also involves indoor space spraying (iss) with pyrethroids (mainly deltamethrin) and organophosphates (malathion) in houses that allow entry. limitations in personnel, geographic extent of outbreaks, and availability of resources (e.g., insecticides) commonly challenge moh operations, reducing the coverage and effectiveness of their actions [ ] . all moh actions will be mapped and included in secondary analyses evaluating the impact of tirs in addition to routine vector control. participants in both arms will have access to any concomitant care they may choose to pursue, including cleaning their own yard and eliminating mosquito breeding habitats or using commercially available insecticide sprays or repellents (e.g., transfluthrin coils). clusters will be located within the areas previously identified as hot-spots of abv transmission [ ] (fig. ) . placing all clusters within areas of high abv incidence will increase power because of higher event rates and decrease the potential for imbalance across trial arms. to reduce contamination and edge effects, while all households in tirs clusters will be offered the intervention, epidemiological and entomological evaluations will occur in the center of each cluster, following a "fried egg" design ( fig. ). entomological interventions that are constrained to a given area suffer from immigration of mosquitoes from untreated neighboring areas, as observed in a recent study that released wolbachia-infected mosquitoes in fresno, ca, and quantified mosquito dispersal up to m from their release point [ ] . by focusing participant enrollment on the central × blocks of the × clusters, we will minimize any contamination in our primary and secondary endpoints emerging from mosquitoes flying into treatment areas (fig. ). this "fried egg" design is novel for vector-borne diseases and has been proposed as a rational approach to quantify the epidemiological impact of vector control [ ] . to prevent selection bias, enrollment into the trial will occur in all clusters before tirs allocation has been determined. to assess power and sample size requirements, we analyzed historical passive surveillance data from the hot-spot census tracts with population size of at least (from our previous work characterizing the abv hot-spot area [ ] ). we used yearly data from to on the number of dengue, chikungunya, and zika cases recorded in children - years each year by census tract [ ] . data were combined into pairs of adjacent years to mimic a -year trial period, and table summarizes the mean incidence (number of cases over -year period/number of children) and intracluster correlation coefficient (icc) for a given -year period [ ] . assuming % incidence over a -year period, % tirs efficacy, an icc of . , and % loss to follow-up, we will require age-eligible children enrolled per cluster for an overall sample size of clusters and children to have % power to detect a significant reduction in abv incidence between arms (table ) . clusters will be selected from the set of census tracts within the abv hot-spot area [ ] that have a total population size of at least and at least children aged - years, per the census (fig. ) . clusters are also selected to maximize the distance between the centroid of each cluster to the centroid of its nearest neighbor also in the trial. given a set of clusters, covariate-constrained randomization [ ] will be used to limit imbalance across trial arms with respect to the following census tract-level variables: population size, per census; population density, per census; percent employed population, per census; and cumulative number of abv cases between and , per passive surveillance. these variables were selected because of their association with abv transmission risk. for each balancing factor, only allocation patterns where the mean value of clusters in group a divided by the mean value of clusters in group b is within / . to . are retained. furthermore, we eliminate any allocation pattern with imbalance in the number of clusters per arm per sector greater than ± . to ensure randomization is not overly constrained, we only consider sets of clusters that have many acceptable allocations into two groups of , satisfying validity criteria proposed by moulton [ ] (e.g., pairs of clusters always or never appearing in the same arm). given the set of allocation patterns that meet the above balancing criteria, the biostatistics team at uf will use equal probability sampling to randomly select one allocation. a sample allocation pattern is plotted in fig. . for participant enrollment, the study teams will be provided with a list of census tracts for inclusion in the study, without a record of which census tracts are in group a or b. a random number generator produced by biostatisticians from uf will assign one group to tirs and one group to control. the trial will focus on the pediatric population, enrolling children aged - years in a longitudinal cohort to track their abv illness and lab-confirmed seroconversion over two (and potentially three) transmission seasons (fig. ) . the previously conducted cohort study in merida indicated that the majority of dengue-naïve infections and seroconversions occurred in children ≤ years old [ ] [ ] [ ] . by following children aged - years at enrollment, we will capture the segment of the population with the highest probability of abv illness. we excluded younger children (< years) because of the difficulties in obtaining blood specimens and potential for cross-reactivity with maternal antibodies [ ] . there will be two levels of participation: at the household level and at the individual child level. table shows the inclusion/exclusion criteria for each level. for each participation level, consent (and assent) will be obtained, as follows. on august , after being given time to review information about the intervention, one adult household decision-maker will be asked for written consent to have their house included in the trial (at the time of consent, neither study personnel nor householders will know to which arm of the trial the house will be allocated). in consenting houses with children meeting the inclusion criteria (table ) , individual consent/assent will be obtained during december -january . parental informed consent will be obtained for children aged - years, and both assent to participate from children and a parental informed consent will be obtained for - -year-olds (additional file ). enrollment of children will be focused in the central × city blocks of each cluster and will extend beyond if not enough children are enrolled in the core. consent will be obtained in participants' homes. study explanations will be provided to small groups of adults present in the household, whereas written consent and assent will be obtained from each individual participant. engaging communities early in the trial will be essential for maximizing participant acceptance and retention [ , ] . an experienced team of social workers, who will interact directly with study participants (through informal conversations, games, and other educational activities with children), will ensure they remain engaged throughout the duration of the study [ ] . several factors may lead one household to withdraw from the intervention. householders may sell their home and move to a different location, and we will consider them lost to follow-up. householders may refuse to receive the intervention on a second or third opportunity, meaning they will not be subject to treatment (and therefore excluded from any future analysis). our team will document voluntary withdrawals and communicate them as part of the trial reporting. trial performance milestones table shows our proposed milestones for the trial, following the spirit checklist, and sections below provide information on each step (see additional file ). they can be divided into (a) trial planning, (b) tirs evaluation, and (c) trial analysis and reporting. trial design will be finished during the first year. enrollment is expected to last up to months, when all children will enter follow-up. trial evaluation will occur for two transmission seasons, with the possibility of adding a third season should incidence of the primary endpoint be lower than assumed. trial analysis will include a projection of tirs impact, based on results from the crct, using our stochastic simulation model fitted to our study population. a baseline assessment of household characteristics (size, building materials, number of rooms, number of inhabitants) and ae. aegypti infestation and susceptibility to insecticides will occur july-december (fig. ) . entomological collections will be conducted monthly in % of all houses located in the centers of the clusters (blue blocks in fig. , equal to houses across clusters). standard ovitraps will be placed to collect eggs that will be reared for assays to characterize insecticide susceptibility in mosquito populations. after the transmission season (january-april ) and during individual child enrollment, a baseline sero-survey will quantify levels of abv seroprevalence. all enrolled children will provide a blood sample by venipuncture, which will be tested for the presence of neutralizing antibodies against denv, chikv, or zikv (see laboratory methods below). personnel from the servicios de salud de yucatan (ssy; yucatan's ministry of health) will conduct the tirs after proper training [ ] . based on our model [ ] . we will prioritize the use of the organophosphate pirimiphosmethyl (actellic cs®), given its longer residual power in comparison to the carbamate bendiocarb (ficam®) [ ] . however, if insecticide resistance profiles of mosquitoes after the first year of spraying show decreases in susceptibility to the active ingredient in actellic cs®, we will switch to ficam®. insecticide application will follow strict procedures developed by project team [ ] . residents will be asked to temporarily leave the house during treatment and wait h for the product to dry before re-entering. staff will wear branded uniforms with identification and use appropriate personal protective equipment. the epidemiological impact of tirs on the primary endpoint will be evaluated by active surveillance to detect and lab-confirm symptomatic denv, chikv, or zikv from july to december of each season (fig. ) . enhanced symptomatic abv case detection will rely on three sources (fig. ). ten field teams consisting of a nurse and a social scientist will conduct wellness visits to all enrolled children once per week, with the goal of identifying any probable case of abv illness. in addition to wellness visits, nurses will call parents/guardians of enrolled children regularly (twice per week) to check for the occurrence of any abv symptoms. when interacting with parents/guardians, nurses will also remind them that they can call our toll-free - number in case of any illness compatible with an abv infection. widely used by the previous cohort, the - number enhanced the detection of symptomatic individuals by providing study participants - access to a toll-free phone number to consult an "on call" project physician about any symptom in their children [ ] . additionally, our project will access the online abv database managed by mexico's national center of preventive programs and diseases control (cenaprece) [ ] to identify all reported symptomatic cases (including all ages, not only children) residing within study clusters in real time, and to map routine vector control actions performed by ssy. for ascertaining the primary endpoint, a suspected symptomatic abv case is defined as a participant with acute onset of fever (axillary temperature ≥ °c) or a non-focal rash plus any additional symptom such as headache, conjunctivitis, arthralgia, or myalgia. when a suspected abv case is identified through active surveillance, they will be visited preferably on the same day by one project physician to perform a physical examination (physical exam, temperature, vital signs). the doctor will be joined by one field team member, who will obtain demographic and behavioral data, and collect blood specimens. acute and convalescent (obtained [range [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] days after symptom onset) blood specimens will be collected from each suspected case to confirm abv infection. additionally, history of movement (by a retrospective movement survey) [ , ] will provide information on potential exposure locations for each case. after laboratory confirmation, participants will meet with study physicians, who will explain the diagnosis and potential steps if symptoms worsen. epidemiological impact will be further assessed via a secondary endpoint capturing serological evidence of abv infection (table ) . yearly blood samples from all enrolled participants will be collected after the regular transmission season (from january to april) to test for serologic evidence of interval infection by denv, chikv, or zikv, as in [ ] [ ] [ ] . in addition to collecting blood specimens, project team will also conduct annual prospective movement surveys to characterize the routine mobility patterns of participants. entomological impact will be measured by standardized monthly collections of indoor adult ae. aegypti (table ) . a random sample of % of the houses located in the center ("yolk" of our fried egg design) of each cluster (~ houses in total) will be visited and surveyed for the presence of adult ae. aegypti mosquitoes indoors using prokopack® aspirator collections performed for min per house, as described in [ , ] . female ae. aegypti collected indoors will be pooled by city block and tested for abv infection. entomological surveys will begin immediately following tirs implementation (july ) and will be performed monthly for months (until dec ). monthly who cone bioassays [ , ] will be done in a random sample of treated houses to monitor the residual efficacy of the insecticide used. venipuncture procedures will be performed using standard aseptic techniques. an experienced phlebotomist will take the blood sample from an antecubital vein. blood will be collected into vacutainer® collection tubes or by a needle and syringe. a -gauge needle will be used for - -year-olds, and a -gauge needle for children < years. blood specimens will be immediately taken to yucatan state diagnostics laboratory, dependent of the ministry of health for immediate molecular diagnostics (acute samples) or serum separation, followed by elisa tests (convalescent samples and annual blood draws). aliquots of all specimens will be stored at − °c in labeled polypropylene cryogenic vials at uady, and then transported to emory university for advanced diagnostics. long-term specimen storage will occur at emory university. specimens from individuals who did not sign the "future use" clause of the consent will be discarded after diagnostics, following sample processing procedures established by yucatan state laboratory. figure shows all lab testing components of the trial, which will occur at ssy, uady and emory university. acute samples from active surveillance will be tested at the yucatan state laboratory using a multiplex reverse transcriptase-polymerase chain reaction (rt-pcr) [ ] and virus-specific igm elisas. annual serologic samples will be tested at yucatan state laboratory by antigen capture elisa for human igg [ ] , and positive samples will be taken to emory university for focus reduction neutralization testing (frnt) [ ] [ ] [ ] . natural abv infection rates in ae. aegypti will be detected by rt-pcr [ ] at uady. standard cdc bottle bioassays [ ] will assess phenotypic resistance of adult ae. aegypti from treatment and control clusters pre-intervention and at and months post-intervention every year. f , or f progeny, from field-collected eggs will be screened for susceptibility to pirimiphos-methyl [ ] . if resistance is detected, both dna and rna will be analyzed from a subset of the phenotyped mosquitoes to calculate the frequencies of known resistance alleles as well as expression of resistance-associated genes. given cross-reactivity and variable sensitivity of assay methods, we will use a composite approach to diagnose abv infections (fig. ) . for active surveillance, two diagnoses are used: preliminary diagnosis-suspected cases are confirmed if rt-pcr is positive for any abv. if rt-pcr is negative, the acute specimen igm result is considered and any positive igm result indicates a preliminary diagnosis of abv infection. if both zikv and denv igm assays are positive, the case is designated as a case of flavivirus infection. final diagnosis-paired acute and convalescent specimens will be tested for igm and igg seroconversion. these results will refine the case designation. a case with laboratory evidence of abv infection in the acute testing must also demonstrate seroconversion or increasing levels of igg or igm in the convalescent specimen. rt-pcr+ suspected cases that do not exhibit seroconversion or increase in igg or igm levels will be designated recent infections, but not abv cases (that is, this result is most consistent with an etiology other than abv infection as the cause of the symptomatic illness). additionally, igg or igm seroconversion or increasing igg that is observed when rt-pcr and acute specimen igm are negative will be considered confirmation of an abv case. this approach may increase the sensitivity to detect abv cases that have false negative pcr testing and have not yet mounted an igm response at the time of presentation. finally, if convalescent serology does not distinguish between denv and zikv infection, the annual surveillance sample for that subject will be considered. if it is clear from neutralization testing on the annual surveillance specimen what the intervening viral infection was, that will become the designation of the abv case captured during active surveillance. the annual serologic surveillance takes into account that the majority of abv infections are inapparent. it will also account for the known cross-reactivity among abvs. chikv is an alphavirus, and serologic assays for chikv perform with high sensitivity and specificity. elisa is likely sufficient for annual chikv serosurveillance. denv and zikv are related flaviviruses, and conventional approaches to serologic diagnosis of flavivirus cases can exhibit reduced specificity. however, the antibody response to denv and zikv is dynamic, and cross-reactive antibody levels are greatest in the first few months after infection. thus, cross-reactivity is present but less intense in late convalescence, which is one reason for performing serosurveillance in the lowtransmission season. for flavivirus surveillance, neutralizing antibody titers will be compared using the frnt (inverse of serum dilution that exhibits % of maximum neutralization). conversion of neutralization assays from negative to positive in subsequent years is strongly supportive of interval infection. the precise infecting virus (denv - serotype or zikv) can often be identified by comparing relative frnt values for each virus. a ≥ -fold difference in the frnt is considered a significant difference. once an individual has high titers to multiple denv serotypes, detection of additional denv infection is challenging by serosurveillance alone. the details of interpreting all possible flavivirus neutralizing antibody profiles are beyond the scope of the article. we have reviewed the key concepts recently [ ] . the primary analysis will estimate the overall efficacy of tirs in reducing the rate of laboratory-confirmed abv illness, where the overall efficacy is estimated as one minus the hazard ratio from a cox proportional hazards model [ ] . the hypothesis test for the primary outcome will be a score test of the null hypothesis that tirs efficacy is ; the two-sided test will be conducted at the α = . level. the cox proportional hazards model will be fit using individual-level data for eligible and consenting children. the primary endpoint will be time to symptom onset of first laboratory-confirmed abd. the time origin will be july prior to the first season, by which time spraying will have been completed. the analysis will consider events occurring between july and december of each year of the study, as this corresponds to the time when the residual effect of the insecticides used in tirs is expected to be active and while active surveillance is ongoing. to account for clustering, the model will include a robust variance estimator with two parameters; one characterizes the level of correlation in outcomes between children within the same household, and one characterizes the level of correlation in outcomes between children in different households but within the same cluster. we will use schoenfeld residuals to assess departures from proportionality, as would occur if the effect of tirs varies over time [ ] . we will use timedependent (piecewise) models where significant nonproportionality occurs [ ] . planned secondary analyses of clinical and human serological data include: cox proportional hazards model with time to first laboratory-confirmed symptomatic abv disease as the endpoint, adjusting for additional cluster-and household-level covariates (e.g., population density, household size, socio-economic status). cox proportional hazards model with time to first laboratory-confirmed symptomatic abv disease as the endpoint, adjusting for routine human movement as measured by the prospective movement survey (measured in all enrolled participants). the proportion of time in treated areas will be included as a further covariate, as described in [ ] . disease-specific versions of the primary analysis (e.g., time to first laboratory-confirmed symptomatic dengue disease as the endpoint), if data permit. analysis of recent human movement measured by a retrospective movement survey in enrolled participants presenting with symptoms for laboratory confirmation. the data will be analyzed using a test negative design-type structure, where individuals testing negative for any abv will serve as a comparator group for individuals testing positive for abv. the analysis will adopt recently developed methods for cluster randomized vector control trials [ , ] . binomial generalized linear mixed effects model to assess the efficacy of tirs for reducing laboratoryconfirmed denv, chikv, or zikv infection will be analyzed as cumulative incidence over the two (or potentially three) transmission seasons, as measured from annual serological samples. given the larger number of sub-clinical and undetected abv infections compared to symptomatic abv illness, the study will be amply powered to detect a statistical difference in abv infections (measured by annual serology). using the passive surveillance data, we will quantify the community impact of tirs on symptomatic abv cases reported to the public health system, beyond our pediatric cohort. poisson regression will be used to compare cluster-level incidence rates across trial arms. acceptability of tirs intervention will be assessed by calculating summary statistics from the postintervention data. acceptability measures will be paired with any adverse reactions experienced or reported by study participants and assessed by our team of physicians. for mosquito data, planned secondary analyses include: the following ae. aegypti adult indices will be calculated for each sampling date and compared between treatments and over time: presence (binomial variable) and abundance (count variable) of adults, females, and blood-fed females per house. generalized linear mixed effects models (glmm) nested at the cluster (level ) and city block (level ) levels will be used to compare each entomological index between treatment and control arms, as in [ ] . link functions for glmms will be binomial for presence indices and negative binomial for abundance indices. the best fit models (after comparing aic values for models including all levels or only level ) will be used to calculate odds ratios (or; for mosquito presence/absence) and incidence rate ratios (irr; for mosquito abundance) using control houses as the unit of comparison. we will calculate the operational efficacy of the intervention as e = ( − irr) × . this measure, ranging between and , describes the percent reduction of mosquito abundance in treated houses with respect to the control. similarly, a negative binomial glmm will test for differences in treatment and control arms for infection rates with denv, chikv, or zikv, calculated as minimum infection rate, following similar statistical methods as for ae. aegypti abundance. epidemiological and entomological information will be combined to quantify the relative reduction in the incidence of symptomatic abv illness at the cluster level observed from a measured entomological reduction due to tirs (measured as number of adult or female ae. aegypti). binomial glmms, with random intercepts at the cluster and year levels, will quantify the association between both variables for the duration of the trial and provide values of threshold vector densities associated with a significant reduction in the odds of human symptomatic infection. transmission modeling our existing mathematical model for yucatan [ , , ] will simulate the effectiveness of tirs for different scenarios of intervention coverage and insecticide residual power, using the observed trial data as a critical model input. this agent-based model of individual people and mosquitoes incorporates household demography, a spatially heterogeneous population structure based on census and remote sensing data, movement of workers and students, and seasonal fluctuations in mosquito population and incubation period. different movement (e.g., mosquito vs. human) and transmission (e.g., pathogen introduction and elimination) dynamics become relevant at different spatial scales; thus, we will predict the impact of scaling up tirs to the entire state rather than treating just merida. simulating epidemiological trends of scaled-up tirs for periods longer than the duration of this trial (e.g., a decade) will evaluate the effect of changing population-level immunity and generate measures of effectiveness that are more informative for programmatic decision making. emory university will coordinate all aspects related to data storage, management, and sharing. a data management core (dmc) provides timely and efficient curation and dissemination of study data from multiple sources (e.g., clinical, laboratory, passive surveillance, entomology, demographic, ministry of health interventions), all essential to the success of the trial (fig. ) . information from the trial including consent forms, surveys, active surveillance forms, laboratory diagnostics, entomological surveys, mobility surveys, withdrawal forms, intervention acceptability, and annual blood draws will be collected in paper form and digitally recorded into our redcap database (see below) by the data entry staff at uady. staff will enter information in a private dedicated space at uady-ucbe. laboratory results at emory university will be entered directly into the redcap database by laboratory staff using an online form. all forms were developed by our team specifically for this study. all data will be stored on secure data servers and kept strictly confidential (with participant identifiers blinded by using non-identifiable ids). households are assigned codes unique to the project database, which are then used to identify all subsequent data we will collect. outside of the database, these codes will not be interpretable, rendering the data effectively unidentifiable without access to our servers. blinding of identifiable data will occur in the analysis stage also. all diagnostics of specimens will be conducted using the sample id, blinding laboratory personnel from any identifiable information or membership of samples to a given study arm. access to the database will be primarily administered through a custom, web-based interface with restricted access privileges and encrypted data transfer (redcap, https://www.project-redcap.org/). different data entry interfaces will be generated for each component. access will be limited to certified project personnel and certified associates, who will be provided unique login and password combinations. database servers will be protected by multiple layers of security. databases will be shared electronically through secure servers among key project personnel for analyses, publications, oral presentations, and project development. regular checks of the database for completeness and accuracy will be performed. the heterogeneous nature of abv transmission may dictate the need for a third transmission season to evaluate the epidemiological impact of tirs. the decision to continue into a third season will follow an event-driven decision process. after the second season evaluating tirs, the statistical team will quantify the number of total primary endpoints. we will pursue the following ranking in order to evaluate whether to stop or continue into a third season: the choice of < endpoints represents the target number of events needed for a power of % when tirs efficacy is %. overall, the risks to study participants are minimal in all of our study procedures ( table ). the most serious risk is related to potential intoxication with the insecticides used in tirs (table ). both actellic cs® and ficam® have been approved by the world health organization (who) for indoor control of mosquitoes [ , ] . the who's hazard assessments concluded that, when used for indoor residual spraying as instructed and at the recommended doses, both products do not pose undue hazards to the spray operators or residents of the treated dwellings [ ] [ ] [ ] . provided that operational guidelines are followed, routine cholinesterase monitoring of spraying personnel during indoor residual spraying programs is not required [ ] [ ] [ ] . during the period of active surveillance, immediately after tirs application, study participants will be contacted regularly ( ×/week in-house or ×/week by phone calls) by our team, who will ask for the presence of any sign of intoxication in any of the members of the house. such contacts will coincide with the epidemiological evaluation of the intervention. in addition to our team's direct contact, households receiving tirs will receive a pamphlet with a - toll-free number for them to self-report any signs of intoxication. once in the presence of a probable case of intoxication, a physician will medically assess the patients to diagnose the extent of their condition. vital signs, together with respiratory distress (i.e., bronchorrhea, bronchospasm) and clinical evidence of cholinergic excess (i.e., salivation, vomiting, urination, defecation, miosis), will be followed until they resume. in cases of severe intoxication, plasma cholinesterase activities will be assessed, together with electrolytes and serum lipase (both tests can be performed at uady's school of medicine public health laboratory, which routinely performs such tests for pesticide occupational exposure assessments). given the insecticide dose and mode of application used in tirs, we expect most intoxications to be mild and resume after exposure ends (i.e., after individuals are exit their home). our preliminary results from our phase ii entomological trial utilizing actellic cs showed that in houses (including individuals) a total of cases ( %) of symptoms compatible with a reaction to the insecticide were detected (vazquez-prokopec et al. unpublished). the most common signs (accounting for % of symptoms) were headache, nausea, and mild skin irritation. however, if the physician considers that a moderate to severe intoxication occurred, serological tests will be performed to confirm the cause of their condition. all probable aes will be noted in the adverse event log (ael), which will be the primary form of communication between physicians and the pi. aels will be filed immediately (one record per event) after the detection of a probable ae (the form will include links to any specific medical record or laboratory record associated with each case). once an ael is filed in the database, the pi will receive an alert requiring his attention. upon conversation with the study doctors, the pi will make an informed decision as to whether the condition represents a reportable ae or not. any ae or unanticipated problems (up; serious, life threatening, or result in death and unexpected and caused by the intervention) involving risk to participants will be notified to the irb within calendar days of their occurrence. emory irb will generate specific forms within their eirb platform to report any aes or ups associated with this study. the irb reports on aes or ups will be received by the nih program officer assigned to this study. in the unlikely situation that ups emerged due to tirs implementation, emory irb and the nih program officer will coordinate with the pi about the temporary or permanent suspension of this study. this project will strengthen a unique us-mexico partnership involving universities and research centers (emory, uady, fred hutch, uf) and federal agencies (cenaprece, mexico's national institute of public health, cdc) together with state agencies (ssy). emory university will lead the project and will be in charge of overall coordination, procurement of commodities (e.g., insecticides, diagnostic reagents), and data coordination, advanced diagnostics, and irb approval. the autonomous university of yucatan will coordinate all aspects of the field implementation of the trial as well as the integration of field and laboratory data streams. trial design will be led by fred hutchinson cancer research center. analyses for the primary and secondary endpoints as well as for evaluation of trial continuation will be conducted by uf (ira longini, natalie dean), with input from biostatisticians from fred hutchinson cancer research center. uf will also lead the mathematical modeling component. technical support will be provided by the us cdc to evaluate patterns of insecticide resistance in space and time. mexico's cenaprece will provide access to the online abv database. the ssy will contribute spraying personnel and access to samples for laboratory testing in support of the trial's active surveillance procedures, as well as help with communication about tirs and the trial's goals. dr. silvina contreras-capetillo, md (hospital o'horan, merida, mexico), expert in clinical aspects of aedes viruses, particularly genetic malformations in zika, will act as an independent trial monitor. the funder (nih) considered the data gathered in this project will be identifiable and certain data types, such as movement interview, are sensitive. the primary risks lie with identifying the individuals who provided information they consider confidential (e.g., movement to private locations). there is a small risk that the repeated blood collections will cause or exacerbate anemia. in-depth interviews (prospective and retrospective movement interviews) risks to study participants are minimal. participants may feel that in-depth interviews take up too much time-but they have the option of ending their participation at any time. there are no sensitive topics covered, but if any participant feels that there is something he/she does not want to talk about, he/she does not need to answer all questions. the low risks associated with the intervention not to merit the establishment of a dsmb. as such, the study team and the nih program officer(s) will communicate directly about study findings, reports from independent trial monitor, continuation rules, and adverse events. any deviation from protocol will require prior approval by the nih program officer. the study protocol and associated documents including informed consent forms are approved by the respective institutional review boards (irb) of all collaborating institutions as well the national institutes of health. the trial protocol was registered on clinicaltrials.gov (nct ) on april , . it will be made clear during the consent process that no information can be shared with anyone other than designated study personnel, the paper and computer files will be well protected, and we will ask that interviews be carried out one-on-one to prevent other family members listening in. consent and assent forms include a separate section where participants give permission to the pi to keep their specimens for future tests or studies. we will take all necessary measures to ensure confidentiality. it will also be made clear to study personnel that any violation of confidentiality would be a fireable offense. all paper data forms will be stored in locked files or cabinets in uady in a specified storage facility with limited access. access to computer data files will be password protected to allow exclusive access to appropriate study personnel. the paper data forms associated with the project (e.g., consent forms, questionnaires, census) will be stored in accordance with irb regulations. should consent be given for future use, then serological samples will be stored indefinitely. the samples will not have any participant identifiers, beyond the participant's code. if, however, consent for future use is not given, the blood samples will be destroyed immediately (using strict protocols at uady for disposal of biological samples) following completion of the project. monitor evaluations will occur once a year and will be timed to occur right after the epidemiological evaluation of tirs (january-march). on every visit, dr. contreras-capetillo will file a monitoring log and a self-monitoring tool form. selfmonitoring will be performed on a random selection of % of study participants. the monitor will also review records of all adverse events as well as the information of any dropouts that occurred between monitoring periods. after the visit, the monitor will submit the self-monitoring tool to the pi, together with any recommendations based on the visit. a phone call between the monitor and the pi will be scheduled, should corrective actions be required. novel tools and strategies that are operationally feasible and widely scalable are desperately needed to prevent and control abvs. this phase iii crct trial will quantify the epidemiological impact of tirs in preventing abvs and generate a definitive evidence base for assessing the public health value of this approach. the heavy reliance on pyrethroid insecticides for mosquito control has led to widespread pyrethroid resistance on a global scale [ ] . the high levels of resistance to pyrethroids found in mexico [ ] , including the yucatan [ ] , prompted cenaprece to expand the chemical groups used for aedes control to other insecticide classes such as carbamates and organophosphates, to which local ae. aegypti are susceptible [ , ] . a recent entomological crct performed in merida, yucatan, demonstrated that utilizing an insecticide to which ae. aegypti were susceptible had a significant impact on indoor mosquito density, as compared to the use of a pyrethroid to which the local population was resistant [ ] . the selection of new insecticide formulations (e.g., microencapsulated insecticides) with longer residual power (ca. - months) can further increase the effectiveness of tirs. fortunately, r&d for new insecticide formulations as well as novel chemistries for vector control has expanded, and new products are at various stages in product development pipelines [ ] . findings from this trial will not only aid in understanding how residual insecticides can function effectively for abv control but also help catalyze r&d for residual insecticide formulations better suited for the surfaces and materials found in urban areas. responding only to symptomatic abv cases likely misses a significant number of cases as a large proportion of abv infections are asymptomatic, which can still successfully infect mosquitoes [ ] and in turn significantly contribute to abv transmission [ ] . findings from a spatially explicit agent-based model of dengue dynamics in yucatan, mexico [ , , ] , suggested that tirs maximal effectiveness occurs when it is deployed preemptively (before the seasonal peak of abv transmission) rather than reactively. our trial will evaluate the preemptive implementation of tirs (spraying - months prior to the beginning of the peak abv transmission season). if found efficacious, the trial will make a strong case for the public health value of preemptive, long-lasting vector control measures against abvs. this finding would contribute to a paradigm shift in aedes control and abv prevention, leading to innovations in the way that interventions are conceptualized and brought to scale in operational settings. while the crct approach itself is largely standard, focusing on adherence to core epidemiological principles [ ] , our trial will incorporate several innovative features into the randomization and analysis. we have modified the covariate-constrained randomization procedure [ ] to include a selection step to maximize the geographical spread of the clusters. this strategy may be useful in future vector control trials. through the use of highly spatially resolved prospective and retrospective movement surveys, we will be able to refine our estimates of tirs efficacy to account for participant time spent in treated and untreated areas [ ] . finally, we are able to directly integrate trial data on mosquito abundance, human movement, and clinical outcomes into an existing mathematical model to better understand the potential population-level impacts of tirs. using statistical simulations to help interpret and contextualize the results of an infectious disease trial is an emerging area of research [ ] . to fulfill the critical need for carefully designed trials for vector control [ ] , this study will provide key data on the epidemiological impact of tirs on abvs and contribute methodologies and approaches for the design of future crcts. at the time of submission, the project is on its second trimester (table ) and main administrative activities have been activated. initial community contacts are expected to occur on mid-october , with concurrent participant enrollment (level ) and baseline serology occurring january-march . such timeline differs months from the original proposed plan, due to the covid- contingency that has limited presence of field personnel accessing households. protocol version . : july , (approved on august , , by nih/niaid/dmid and on november , , by emory university irb). urbanization and globalization: the unholy trinity of the (st) century zika virus global expansion of chikungunya virus: mapping the -year history the global distribution and burden of dengue global spread of dengue virus types: mapping the year history economic and disease burden of dengue in mexico an estimate of the global health care and lost productivity costs of dengue. vector borne zoonotic dis after the epidemic: zika virus projections for latin america and the caribbean cost-effectiveness of increasing access to contraception 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wild populations estimating intraclass correlation for binary data covariate-based constrained randomization of grouprandomized trials decay and persistence of maternal dengue antibodies among infants in bangkok what makes community engagement effective?: lessons from the eliminate dengue program in queensland australia studying sociocultural factors associated with dengue fever in elementary school children in yucatán, mexico. sage research methods cases pan american health organization. manual for indoor residual spraying in urban areas for aedes aegypti control. washington: pan american health organization spatial variation of insecticide resistance in the dengue vector aedes aegypti presents unique vector control challenges bioefficacy of two nonpyrethroid insecticides for targeted indoor residual spraying against pyrethroid-resistant aedes aegypti nation-wide, webbased, geographic information system for the integrated surveillance and control of dengue fever in mexico strengths and weaknesses of global positioning system (gps) data-loggers and semi-structured interviews for capturing fine-scale human mobility: findings from iquitos multi-scale analysis of the associations among egg, larval and pupal surveys and the presence and abundance of adult female aedes aegypti (stegomyia aegypti) in the city of merida the impact of indoor residual spraying of deltamethrin on dengue vector populations in the peruvian amazon performance of the trioplex real-time rt-pcr assay for detection of zika, dengue, and chikungunya viruses detection of anti-arboviral immunoglobulin g by using a monoclonal antibody-based capture enzyme-linked immunosorbent assay guidelines for plaque-reduction neutralization testing of human antibodies to dengue viruses in-depth analysis of the antibody response of individuals exposed to primary dengue virus infection comparison of plaque-and flow cytometry-based methods for measuring dengue virus neutralization guideline for evaluating insecticide resistance in vectors using the cdc bottle bioassay serologic tools and strategies to support intervention trials to combat zika virus infection and disease design and analysis of vaccine studies partial residuals for the proportional hazards regression model time-dependent covariates in the cox-proportional-hazards regression model cluster-randomized testnegative design trials: a novel and efficient method to assess the efficacy of community-level dengue interventions analysis of clusterrandomized test-negative designs: cluster-level methods projected impact of dengue vaccination in yucatan designing effective control of dengue with combined interventions pdf; jsessionid= c cf ee afd d e c ?sequence= insecticides approved for indoor residual spraying contemporary status of insecticide resistance in the major aedes vectors of arboviruses infecting humans insecticide susceptibility status in mexican populations of stegomyia aegypti (= aedes aegypti): a nationwide assessment disruptive technology for vector control: the innovative vector control consortium and the us military join forces to explore transformative insecticide application technology for mosquito control programmes asymptomatic humans transmit dengue virus to mosquitoes cluster randomised trials simulations for designing and interpreting intervention trials in infectious diseases springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors acknowledge scott ritchie for his inspiring contribution to the development of the tirs methodology. drs. michael dunbar, gregor devine, richard reithinger, gabriela gonzalez-olvera, wilbert bibiano-marin, and amy crisp provided feedback for the design or conceptualization of the trial. the findings and conclusions in this paper are those of the authors and do not necessarily represent the official position of the centers for disease control and prevention or the national institutes of health. supplementary information accompanies this paper at https://doi.org/ . /s - - - . the full trial protocol will be made publicly available within year of the conclusion of data collection. the datasets generated in this study will be made available by the corresponding author on reasonable request, within year of the conclusion of data collection. this trial protocol has been approved by emory university (irb ) and the autonomous university of yucatan (cei- - ) and endorsed by the secretarias de salud de yucatan. written consent/assent will be obtained from participants and kept in a secure place for record-keeping and trial monitor evaluation. the authors declare that they have no competing interests.author details unidad colaborativa de bioensayos entomológicos, campus de ciencias biológicas y agropecuarias, universidad autónoma de yucatán, merida, key: cord- -r teblhs authors: dibenigno, julia; kerrissey, michaela title: structuring mental health support for frontline caregivers during covid- : lessons from organisational scholarship on unit-aligned support date: - - journal: nan doi: . /leader- - sha: doc_id: cord_uid: r teblhs background: although the covid- pandemic exposes frontline caregivers to severe prolonged stresses and trauma, there has been little clarity on how healthcare organisations can structure support to address these mental health needs. this article translates organisational scholarship on professionals working in organisations to elucidate why traditional approaches to supporting employee mental health, which often ask employees to seek assistance from centralised resources that separate mental health personnel from frontline units, may be insufficient under crisis conditions. we identify a critical but often overlooked aspect of employee mental health support: how frontline professionals respond to mental health services. in high-risk, high-pressure fields, frontline professionals may perceive mental health support as coming at the expense of urgent frontline work goals (ie, patient care) and as clashing with their central professional identities (ie, as expert, self-reliant ironmen/women). findings: to address these pervasive goal and identity conflicts in professional organisations, we translate the results of a multiyear research study examining the us army’s efforts to transform its mental health support during the wars in iraq and afghanistan. we highlight parallels between providing support to frontline military units and frontline healthcare units during covid- and surface implications for structuring mental health supports during a crisis. we describe how an intentional organisational design used by the us army that assigned specific mental health personnel to frontline units helped to mitigate professional goal and identity conflicts by creating personalised relationships and contextualising mental health offerings. conclusion: addressing frontline caregivers’ mental health needs is a vital part of health delivery organisations’ response to covid- , but without thoughtful organisational design, well-intentioned efforts may fall short. an approach that assigns individual mental health personnel to support specific frontline units may be particularly promising. abstract background although the covid- pandemic exposes frontline caregivers to severe prolonged stresses and trauma, there has been little clarity on how healthcare organisations can structure support to address these mental health needs. this article translates organisational scholarship on professionals working in organisations to elucidate why traditional approaches to supporting employee mental health, which often ask employees to seek assistance from centralised resources that separate mental health personnel from frontline units, may be insufficient under crisis conditions. we identify a critical but often overlooked aspect of employee mental health support: how frontline professionals respond to mental health services. in highrisk, high-pressure fields, frontline professionals may perceive mental health support as coming at the expense of urgent frontline work goals (ie, patient care) and as clashing with their central professional identities (ie, as expert, self-reliant ironmen/women). findings to address these pervasive goal and identity conflicts in professional organisations, we translate the results of a multiyear research study examining the us army's efforts to transform its mental health support during the wars in iraq and afghanistan. we highlight parallels between providing support to frontline military units and frontline healthcare units during covid- and surface implications for structuring mental health supports during a crisis. we describe how an intentional organisational design used by the us army that assigned specific mental health personnel to frontline units helped to mitigate professional goal and identity conflicts by creating personalised relationships and contextualising mental health offerings. conclusion addressing frontline caregivers' mental health needs is a vital part of health delivery organisations' response to covid- , but without thoughtful organisational design, well-intentioned efforts may fall short. an approach that assigns individual mental health personnel to support specific frontline units may be particularly promising. the covid- pandemic has unleashed extraordinary stresses on frontline caregivers, from personal exposure risk and fears of infecting loved ones to extreme and unfamiliar workloads while facing moral dilemmas and intense suffering in patient care. healthcare organisations' ability to support frontline caregivers' mental health needs is widely considered essential as the pandemic draws ongoing waves of critically ill patients to their doors. however, the call to care for others often eclipses caregivers' attention to their own well-being, and even under typical circumstances, they suffer from high rates of burnout, stress, trauma and suicide. these challenges are amplified by the pandemic; for instance, a survey of covid- caregivers in china found that % reported distress; % reported depression; and % reported anxiety. healthcare organisations report that traditional approaches to supporting employee mental health, such as employee assistance programmes, are falling short under the present crisis conditions. yet, there has been little clarity on why this is the case and what alternatives may be better. translating findings from organisational scholarship on professionals working in organisations during rapid change, this paper informs the vital question of how to support professional caregivers' mental health needs by elucidating professionals' reactions to organisationally sponsored mental health services. organisational scholarship has demonstrated how professionals experience goal and identity conflicts that undermine frontline professional cooperation with organisational support efforts. frontline leaders and workers, especially in fields characterised by high stress and high risk, may perceive mental health supports as distracting from all-consuming frontline work goals (ie, patient care) and as going against their valued professional identities (ie, as expert, self-reliant ironmen/women). because most traditional organisational mental health structures put the onus on employees to seek help and separate mental health personnel from frontline units, they neglect to create opportunities to develop the familiarity and contextualised awareness between mental health personnel and frontline units that can help to align seemingly conflicting goals and bridge identity differences. without attention to these critical issues-and intentional efforts to design mental health offerings that address them-well-intended efforts to meet caregivers' mental health needs during covid- are likely to fall short. this paper proceeds in three parts. first, we synthesise organisational research on professionals in organisations to articulate how goal and identity conflicts arise within organisations and elucidate why these conflicts can undermine well-intended organisational efforts to support professionals during a crisis. second, we describe findings from a major multiyear ethnographic research study examining an effort to deliver mental health support in a professional arena with strong parallels to healthcare during covid- : the us army during the wars in iraq and afghanistan. this in-depth translation of a research study in a parallel context illustrates the problems that professional goal and identity conflict can pose for providing crisis-related mental health support and surfaces an alternative approach that is rooted in research and theory on organisational design. third, we discuss the implications of the army study for healthcare organisations and highlight the potential for skilful organisational design to help address goal and identity conflicts by assigning mental health personnel to support specific frontline units. these lessons from organisational scholarship and the us army's experience provide critical insight into how healthcare organisations can structure mental health support for frontline caregivers during covid- . scholarship on professionals in organisations elucidates two important barriers to the use and effectiveness of employee mental health support during crises: goal conflict and identity differences between frontline units and professional mental health personnel, described in detail as follows. classic organisational scholarship finds goal conflict is endemic within organisations, as specialised units and different professional groups often have their own interests and prioritise their own goals which may conflict. [ ] [ ] [ ] even when shared organisational goals exist, such as to support the mental health of an organisation's workforce while ensuring quality service delivery, entrenchment in one's own group's perspective from their professional training and position in the organisational structure can make shared goals difficult to achieve. this can lead to regular conflict between frontline units and members of professional groups brought in to support them, leading to suboptimal outcomes. when implementing mental health support in frontline healthcare environments, perceptions of goal conflict are reasonable to expect. both frontline unit leaders and staff may view mental health support as detracting from patient care goals; for example, research in surgery finds perceptions of a zero-sum conflict between being 'ironmen' who are fully dedicated to patient care / and complying with wellness-oriented interventions that limit work hours to promote sleep and prevent burnout. such goal conflicts are likely further heightened in a crisis that accentuates time constraints, as covid- has done. taking time away from care delivery for mental health may be seen as creating further team burdens on the unit, a common saying within healthcare being 'if you are not rounding, you are being rounded on', implying the only acceptable excuse for not providing patient care is becoming a patient oneself. by contrast, in line with their own professional training, mental health personnel may prioritise the mental health needs of caregivers over frontline units' near-term patient care goals. organisational research has identified a number of mechanisms through which goal conflict can be addressed. these include, for example, establishing formal rules and guidelines for interaction across groups ; establishing cross-functional teams, task forces and departments ; implementing collaborative incentives ; and deploying colocation or matrix structures. these mechanisms rationally rely on the idea that better aligning goals through rules, incentives and authority structures will be sufficient to bridge goal conflicts; however, many conflicts in organisations have proven immune to such rational attempts at goal alignment. when there are deeply held differences in identities between groups-as there likely are between those on frontline units and mental health support personnel-such rational mechanisms can prove ineffective. identity differences between professional groups and departmental units within organisations can exacerbate goal conflicts, making them heated and personal. identity refers to how a group collectively defines 'who they are', including their distinctive values, beliefs and sense of what being a good-standing member entails, and they are often apparent in members' common dress, language and demeanour. identity differences are prevalent across professional groups, for whom 'who they are' (their professional identity) is intimately connected with 'what they do' as professionals. professional group members are often especially committed to advancing goals congruent with their strongly held professional identities. for example, in many healthcare specialties, training and culture prize professional identities in which one is tough, desensitised and self-reliant in response to traumatic situations. these qualities are largely considered part of being a good professional caregiver, what has been described as the 'historic "iron doc" culture' of medicine. such professional identities run counter to identities associated with mental health professionals as supporting vulnerability and seeking help. the prevalent labeling of frontline caregivers as 'heroes' as they serve amid covid- may further buttress this identity, perhaps making it even harder to overcome the stigma of admitting a need for support and to relate positively with mental health personnel. because identity runs deep in individuals, goal conflicts arising across groups with different identities can be difficult to ameliorate through rational means alone. for example, research has documented how inviting physician and hospital administrator groups prioritising different goals (eg, providing quality patient care and managing a profitable hospital) to a strategic planning retreat without addressing identity differences can backfire and further fuel their conflict. similarly, because there are likely identity differences between mental health personnel and frontline caregivers, particularly those in emergency and intensive care units known for their stoicism amid trauma, there is potential that mental health resources go underused and underappreciated because they are considered out of touch with the realities of frontline units' unique professional identities. in sum, organisational scholarship on professionals in organisations suggests goal conflict and identity differences between mental health and frontline caregiver professional groups may pose substantial barriers to the use and usefulness of mental health support during covid- . with goal and identity conflict posing stark challenges to providing mental health services to frontline professionals, integrative solutions that equip organisations with practical strategies to address conflicting goals and identity differences are vital. to shed light on potentially useful strategies for structuring mental health support during covid- , we further describe findings from a major multiyear ethnographic research study conducted from to examining an effort to deliver mental health support in a professional arena with strong parallels to healthcare during covid- : the us army during the wars in iraq and afghanistan. [ ] [ ] [ ] [ ] [ ] translating research and evidence us army case: anchored personalisation during the wars in iraq and afghanistan, the us army sought to transform its mental health services to better support soldiers' needs, given increased rates of post-traumatic stress disorder and suicide. however, much like healthcare workers during covid- , soldiers in the us army faced the dual challenge of prolonged periods of high personal risk and stress, combined with intense demands to be 'field ready' and 'tough. in-depth research examining army brigades and mental health clinics over time (through over in-depth interviews and hours of on-site observation) indicated that most traditional mental health support initially went underused, due to many of the professional goal and identity issues described earlier. mental health support provoked resistance from soldiers' supervisory commanders, who often discouraged soldiers from using mental health services, fought treatment recommendations (eg, to allow a soldier to sit out of a stressful training exercise) and emphasised long-standing prejudices about mental health personnel (eg, calling them 'berkeley hippies'). meanwhile, mental health personnel, stereotyping commanders as 'bullies', remained removed from soldiers' unique units and work environments, and made recommendations often considered inappropriate for valued mission-readiness goals or unnecessarily damaging to soldier career aspirations. however, this research also uncovered an alternative approach that resolved the pervasive and long-standing goal and identity conflicts between mental health support and frontline unit supervisors and members. rather than providing centralised resources that soldiers were expected to proactively seek out, a dedicated mental health clinician was assigned to work specifically with a few frontline units. this was the structure ultimately implemented across the us army after experimenting with numerous other structures. - this approach enabled what is called 'anchored personalisation'. 'personalisation' occurred as mental health personnel developed personalised relationships and familiarity with the frontline unit members and leaders they were assigned to support. this both helped mental health personnel to customise the support they offered to suit the unique needs of individuals in their specific units and to reduce the stigma supervisory commanders and soldiers attached to mental health services that ran counter to their selfreliant 'warrior' identities. in working with and learning about specific units, mental health personnel were able to design support that was sensitive to the specific mental health needs of soldiers in their units, as well as their career aspirations and unit goals (eg, discretely assigning a soldier to a less stressful role during a training exercise). because these mental health personnel saw patientsoldiers in the same units, they also learned about unit-level issues that helped them tailor supports. making mental health personnel accountable for learning about the unique needs of their assigned units spurred them to devise support that resonated with rather than conflicted with frontline professional identities. in so doing, feelings of stigma began to change; for example, using mental health services started being framed as 'a sign of strength' or 'being man enough to get help', which aligned with the professional identities of many in all-male combat units. at the same time, this approach ensured this personalisation was balanced by 'anchoring', in which the mental health personnel who were assigned to different units regularly came together, helping one another remain anchored in their professional goals of supporting mental health and resist the demands of frontline units' leadership that sometimes ran counter to soldier well-being. the concept of anchored personalisation for mental health support provision is rooted in organisational scholarship on personalisation. research on personalisation, defined as regular, individuated one-on-one contact across groups, has been found to reduce intergroup stereotyping and lead to increased perspectivetaking as members of different groups develop familiarity with and knowledge about one another as people rather than stereotypes in a variety of contexts. such perspective-taking can enable people to break out of their entrenched worldviews to find integrative solutions that are win-win for both groups. however, personalisation can also become problematic if personalised contact with the other group leads to co-optation and indoctrination into the other group's perspective, a phenomenon exhibited among bankers through 'regulatory capture' and affirmative action officers protecting their organisations over advocating for employees. it is for this reason that maintaining an anchoring contact with one's home group is vital for mitigating risks of co-optation when personalisation transpires. although there are certainly differences between professional soldiers who train to endure prolonged traumatic situations at war and frontline caregivers suddenly confronting unexpected traumatic situations brought by the covid- pandemic, there are two central insights from the us army's experience structuring mental health support that are especially relevant for the challenge of providing mental health support for frontline caregivers. first, if personalisation is vital to breaking down barriers to mental health across professional differences, then relying on it to happen by chance is likely insufficient, particularly in high-risk, high-pressure fields like the military and healthcare. because organisational structures shape the types of interactions members have with others inside their organisations, when properly designed, the right structures can offer opportunities for regular interaction, familiarity and personal relationships between members of the organisation outside one's home group. in healthcare, organisational design is a critical lever for structuring and institutionalising effective care delivery. intentional organisational design may be a key lever through which healthcare organisations can ensure mental health offerings achieve their intended impact. the second central insight emerging from the us army case is that the specific strategy of assigning mental health personnel to a few specific frontline units may be particularly advantageous. because it enables anchored personalisation, this strategy may help mitigate goal conflict and identity challenges related to mental health support usage in healthcare, such as limited time and a culture of 'toughing it out', that make mental health resources so difficult for caregivers to seek out and use in practice. if unit staff, and particularly unit leaders, become more familiar with a dedicated mental health support person through personalised interactions, together they can break down stigma and stereotypes, take one another's perspectives and become partners in jointly devising contextualised ways of supporting unit staff well-being that are customised and minimally disruptive to patient care. doing so may also help personnel frame mental health services in ways that resonate with specific units to encourage use, such as by relabeling mental health as 'psychosocial support' or 'resiliency coaching', or by tapping into the self-sacrificing identity of many caregivers through emphasising how use of mental health support may enable sustained high quality care for patients. customisation of mental health support is particularly critical because the specific stresses brought on by covid- vary across translating research and evidence different departments and units. for example, the mental health needs of a covid- intensive care unit with nurses isolated behind closed doors with gravely ill patients may differ from those of emergency department staff interacting with large numbers of patients whose covid- status may yet be unknown. in addition, time constraints across units vary; for example, especially busy units may require more proactive identification of who needs help, such as from assigned peer 'buddies' or leaders, while others may require daily decompression huddles with their assigned mental health personnel purposefully making themselves available afterward to do one-on-one follow-ups. at the same time, ensuring mental health personnel maintain connection with those in similar roles serving other units can help them stand firm on the importance of supporting mental health goals, even when time demands and the culture of medicine may default to relegating mental health back to the sidelines. addressing caregivers' mental health needs is a vital part of health delivery organisations' response to the covid- crisis, but without thoughtful organisational design, even wellintentioned efforts may fail. organisational research elucidates how goal and identity conflict can undermine such efforts in professional organisations and has explored possible solutions that can be built into the design of mental health support. based on findings from a in-depth study of the us army's evolution of its mental healthcare support for frontline units, a design that assigns individual mental health personnel to support specific frontline units may be particularly promising during covid- . because it enables anchored personalisation, this design can help professional caregivers and mental health personnel bridge their differences and devise innovative solutions that increase the use and usefulness of mental health support. implementation of versions of anchored personalisation in response to covid- is already occurring, with examples in systems such as university of california's zuckerberg san francisco general hospital and yale new haven hospital. these and related efforts to thoughtfully apply organisational structures to better support caregiver mental health will remain vital as the early crisis fades, but the pressure on frontline caregivers endures and resurfaces as the pandemic continues. perhaps such efforts will also help revitalise how mental health, stress, trauma exposure and burnout are addressed in healthcare delivery, even after this crisis, to better support the frontline caregivers who serve patients day after day. understanding and addressing sources of anxiety among health care professionals during the covid- pandemic preventing occupational stress in healthcare workers factors associated with mental health outcomes among health care workers exposed to coronavirus disease all hands on deck: how uw medicine is helping its staff weather a pandemic a behavioral theory of the firm managing intractable identity conflicts multiple and competing goals in organisations: insights for medical leaders explaining the selection of routines for change during organizational search challenging operations: medical reform and resistance in surgery antecedents and consequences of project team 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managers post-traumatic stress innovations final report: transforming the psychological health system of care in the us military transformation of the us army behavioral health system of care: an organizational analysis using the 'three lenses transformation of mental health care for u.s. soldiers and families during the iraq and afghanistan wars: where science and politics intersect the application of the personalization model in diversity management caught in the revolving door: firm-government ties as determinants of regulatory outcomes legal ambiguity and the politics of compliance: affirmative action officers' dilemma structural contexts of opportunities team scaffolds: how mesolevel structures enable rolebased coordination in temporary groups the necessity of others is the mother of invention: intrinsic and prosocial motivations, perspective taking, and creativity we are grateful to the healthcare leaders and frontline caregivers working during the covid- pandemic for whom we hope this article will be of service to. we also thank amy wrzesniewski and marissa king for reading a prior version, amit nigam for his encouragement to write this translation piece, and the bmj leader editorial team for thier rapid turnaround of this work. the views and conclusions contained herein are those of the authors and do not necessarily reflect the views of the us government or us army. contributors jdib and mk played an equal role in conceptualising and writing this article.funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.competing interests none declared. key: cord- - l dxc authors: bradbury, sarah title: mind over matter date: - - journal: bdj in pract doi: . /s - - - sha: doc_id: cord_uid: l dxc nan a study conducted by researchers from the university of sheffield and ulster university found that on tuesday march, the day after the prime minister told the british public to stay at home, % of study participants reported significant depression and % anxiety. this compared with % and % respectively the day before the announcement. what's more, in april the lancet announced that researchers from around the world, including a professor from the university of bristol, would form the international covid- suicide prevention research collaboration, due to the international concerns about the increase in mental health issues. for some people the isolation of feeling confined to their home had a severe impact on their mental health -too much worry, stress or even boredom can have an effect, and if not recognised and dealt with, could see you suffering way beyond the time a vaccine is found for covid- . and for many of us it wasn't just the lockdown that caused stress, it was the worry of going back to our previous lives; stressful or crowded commutes and for all principals the financial pressure of running a business or potentially having to close the practice because of a covid case, for example, all added to the pressure. and away from the world of work are the responsibilities of families, our health and that of our loved ones, the expectations of a social life with friends and an exercise regime to fit in. basically, our lives being so full they feel overwhelming, and the more the 'pre-virus' world becomes unreal, the more we have to start from scratch to create a 'new normal' . katherine may, author of the book 'how i learned to flourish when life became frozen' wrote in the observer in april this year: "this moment of mass confinement sees many of us grappling with a sudden sense of irrelevance, of being restrained from succeeding. we are urged to think of the bigger picture, and we do, but that does nothing to soothe the sense that our life's work -the sum total of our ambition -is now considered petty… in less interesting times, we will meet acquaintances on the street and tell each other how busy we are, what a rush we're in, how fast life is. in fallow periods, time opens up, and we read it as an insult. the outside world does not require us. we are surplus stock, just another human body… but there is unpicking to be done here, because the pace at which we live is so often destructive. being busy makes us skim over life like a stone on still water. in quieter times, we can feel the presence of all the things we miss in our hurry. " for some, the lockdown provided positive effects on their mental health. once we got into the routine and flow, it gave many of us a chance to step back from our daily grind and find some peace and tranquillity. not feeling guilty about savouring a quiet moment of contemplation, listening to the birds sing, stopping and feeling the warmth of the sun, going for a walk in an unexplored area locally the dental profession for any dental professional, the knowledge of not being able to care for your patients, often whom you have long-term relationships with, was deeply unsettling. added to this having to try to give online consultations with the implications and long-term harm of diy dentistry and not even knowing if the business will ride the storm. taken together all this can be very stressful indeed. in a recent dental defence union (ddu) survey % of dental professionals think their stress and anxiety has worsened since the pandemic began, with around half feeling that they couldn't do their jobs properly. moving on to a 'new normal' is even harder when there is limited ppe for dental professionals, social distancing is needed in practices and additional government guidelines to follow. the bda, for example, has a detailed faq page that is updated regularly, as well as a live updates page. these can be useful resources as a one stop shop to keep you up to date on changes with what treatments are permitted, news on regional toolkits and a summary of the governments' changing guidelines on the way you should now work. for england, and there is some variation for wales, northern ireland and scotland, the chief dental officer has published standard operating procedures to cover a phased return for dental practices. from june this year, dental practices were tasked to ensure that staff always wear a surgical mask when not in ppe, that staff should self-isolate for days if they've been in contact with someone covid- positive and that practices should follow nhs test and trace requirements. from july, all practices were given the green light for face-to-face contact as required, but still with certain restrictions, so it's important to ensure things don't become even more stressful for you when trying to follow guidelines to protect your patients and teams. mind, the uk national mental health charity, has worked for over years to improve the lives of those who experience mental health problems. they provide specific advice online on how to deal with the personal repercussions of the covid- pandemic, from ways to connect with others and stimulate your mind, to how to relax and ways to view the news in a more pragmatic way. bda president roz mcmullan has meanwhile been working to support the mental wellbeing of frontline staff during the crisis, and in a blog in june discussed the level of stress dentists are under and suggested three strategies for coping: not ignoring the signs of stress, empowerment through supporting colleagues and considering what information you consume. , she was also the lead in a bda event in february this year, that gathered key stakeholders in uk dentistry to see how they could collaborate on improving the services and support for the mental health and wellbeing of dentists, as it has always been an important consideration, even before the pandemic hit. currently, bda members can access counselling services and a -hour confidential helpline, but any dental professionals can access the dental health support trust. there are also a number of closed online groups where dental professionals can join to support each other. many local dental council's (ldcs) also offer practitioner advice and support schemes (pass) in a number of areas and hope to expand around the country. there is also the dental health support programme (dhsp) providing mental health and addictive disorder support. in england, dentists recently gained access to the nhs practitioner health programme (php) and in northern ireland similar support is available through inspire. many indemnity organisations also provide counselling services and courses, so there is support at every turn if you look for it. bear in mind that the gdc does expect dental professionals to look after their own health in the interests of providing safe care for patients. standard . reminds dental professionals that you may not be best placed to identify or assess your own health concerns. what now? we have already learnt new ways to communicate in our personal and professional lives, whether it is video consultations or talking to a neighbour -with a two-metre gap of course! and if the personal, professional or financial sacrifices that we have made to protect the society we live in don't lead to some lasting improvements from an environmental or societal point of view, then it is a sad reflection on our inability to adapt and find positives despite unwanted change. it has given leaders and individuals a chance to see real opportunities for positive change, which could help us all have a more fulfilled life, understanding a bit better how to look after our mental health and that of others. world health organisation. mental health and psychosocial considerations during the covid- outbreak news release: depression and anxiety spiked after lockdown announcement, coronavirus mental health study shows suicide risk and prevention during the covid- pandemic living in our isolation bubbles can bring great rewards the lockdown paradox: why some people's anxiety is improving during the crisis available online at: www.theguardian.com/society/ /may/ / shortage-of-ppe-may-force-reopened-dentiststo-limit-treatments news release: ddu launches new employee wellbeing helpline for dental members british dental association. coronavirus: live updates. available online at available online at: www.mind.org.uk/informationsupport/coronavirus/coronavirus-and-your-well being/#takingcareofyourmentalhealthandwell being dentistry and mental health: what next? available online at: www.gdc-uk. org/docs/default-source/standards-for-thedental-team/standards-printer-friendly-colour. pdf?sfvrsn= cffb _ key: cord- -rw okd p authors: westgarth, david title: what does the future hold for the workforce of tomorrow? date: - - journal: bdj in pract doi: . /s - - -x sha: doc_id: cord_uid: rw okd p nan on february , the british dental association and public health england chaired the first mental health and wellbeing day bringing together attendees from across the dental profession to discuss the problems with and solutions to stress, burnout and mental ill health among dentists. less than five weeks later, lockdown happened and the dental profession downed tools. much of the focus then fell on securing the economic livelihoods of those affected -furlough requirements, business interruption insurance and business rates relief became (and still are) buzzwords. and while it became clear that economic recovery of the sector and the country were the first and foremost priorities, 'people' were left behind. could we see loved ones, parents, grandparents? no. for many -including myself -it was weeks of solitude. while i am fortunate to have survived with much of my sanity intact, for others the very problems discussed at the mental health and wellbeing day came to the fore. according to a new poll by the mental health charity mind, many people who were previously well will develop mental health problems as a 'direct consequence of the pandemic and all that follows' , with the worst yet to come. two out of three adults aged and over and three-quarters of young people aged - with an existing mental health problem reported worse mental health during the lockdown, its survey found. of adults with no previous experience of poor mental health, % said that their mental health is poor or very poor. those who were furloughed, changed jobs or lost their job due to coronavirus saw their mental health and wellbeing decline more than those whose employment status did not change, the research revealed. of those who tried to access nhs mental health services, % were unable to get support, the survey found. a further % of adults and % of young people did not try to access support because they did not think that their problem was serious enough. while the mental health event could not foresee what was around the corner, these issues were brought up. where can dentists get mental health support? at what point does an individual realise they need to talk to someone? are mental health problems on the increase? you had a perfect storm; furloughed, concerns about livelihoods and day-to-day finances, with many doing it alone and without the support they needed and of course an overarching concern about what the future actually holds. bda president and chair of the mental health and wellbeing day, roz mcmullan explained it is that overarching uncertainty that has the potential to have the greatest impact on the mental health of those affected. 'life is a marathon not a sprint and is inherently uncertain with many ups and downs. you said it yourself -uncertainty. there are hills in the marathon, we see them coming and we can and should prepare; for example, buying a practice, starting a family, a parent needing support. there are potholes, when we have no chance to prepare and these can be very destabilising, for example a complaint, death of a loved one, and of course a pandemic. 'in this pandemic we need to add financial pressures, anxiety about covid- itself and risks of transmission to patients, staff and family, family disruption, the need to manage schooling and caring responsibilities and possibly deal with the grief of losing a loved and cherished member of the family. this list is by no means exhaustive. no wonder research for the bda shows signs of burnout in over % in gdps. 'our early career dentists and students have been real heroes in this pandemic, many being deployed to roles on the front line. however they are now returning to the uncertainty of missing time in training, new ways of assessing competency and even 'will there be a job?' . 'the anxiety of uncertainty is normal and to be expected. i hesitate to use the 'for those who hold leadership roles in the team and in training, show humility, humanity and sensitivity and try and model appropriate behaviours. leaders should be prepared to delegate and ask for help. this will be a long road. be sensitive to those in the team who are feeling vulnerable, acknowledge their feelings and ensure they are not experiencing harassment or even bullying. 'but above all maintain professional and social networks. regular team meetings in the workplace with effective reflection and twoway communication are very effective. bda amongst others are organising virtual branch and section meetings and online platforms are a good, if imperfect, way to catch up with friends and peers. try and separate your home and work life, although that is easier said than done when you go home and the tv is full of news about covid- . ' above all, be kind to yourself: eat, sleep, exercise and take some time out of dentistry to do something you enjoy and get satisfaction from. and remember, it is ok not to be ok. if you need help, then please do reach out. ' lauren harrhy, practice owner and founder of mental dental, suggested the mental health impact on the profession has been -and will continue to be -profound. 'i know from experience colleagues have felt quite downtrodden and powerless, scared and frustrated over this period' , she said. 'there has been uncertainty over possible job losses and disputes over pay. many have found sourcing ppe a huge challenge and getting used to wearing it yet another massive hurdle. 'i know that young dentists in particular have found the mental adjustment to implementing aaa quite difficult. we are so used to hearing that antibiotics don't cure toothache; it has felt strange and unnatural to prescribe antibiotics over this time. many are suffering great moral injury because they have not been able to care for their patients in the way they would like to. ' dental core trainee alice duke also found 'the new norm' difficult. 'it has been challenging, especially as a dental core trainee where much of the focus is on learning new clinical techniques and gaining clinical experience in new disciplines' , alice said. 'i felt very anxious during the first few weeks and found it difficult to sleep, as did many of my colleagues. i had just moved departments from restorative to paediatrics/ orthodontics and found it difficult to adapt to the constantly changing protocols, as well as working alongside new staff. 'i spent a few weeks working from home which involved helping to develop new standard operating procedures to be used in the department. i also had the opportunity to be involved with research and quality improvement. i did feel disconnected from the profession during this period and missed the clinical environment. 'dentistry is a profession founded on principles of communication with colleagues/ patients and teamwork, so adapting to working alone in an office environment took some adjustment. i found planning my day and participating in many virtual meetings/ discussions/webinars helped me to remain engaged and motivated. ' special care dentistry registrar natalie bradley discussed her sudden shift in focus and the stress that carried her and many others who found themselves in urgent dental care hubs. 'many hospitals have had to adapt to become urgent dental care hubs during the peak of the pandemic, with both the hospitals i work in beginning to start to resume some ' according to a new poll by the mental health charity mind, many people who were previously well will develop mental health problems as a 'direct consequence of the pandemic and all that follows', with the worst yet to come.' routine services. but the number of patients we have capacity to safely see is dramatically fewer than usual and there is going to be a large backlog of patients to see. waiting lists will be affected and in some cases, patient criteria have become much stricter in order to reduce waiting times for priority patients. patients who were on waiting lists before the pandemic may now receive letters saying they no longer fit the criteria to be seen in hospital and need to seek care elsewhere. 'in this time their oral health may have deteriorated and their needs increased, which is a problem on the horizon the profession will need to tackle. ' thankfully, this isn't to do with letters, the office of the chief dental officer or returning to work, but rather the future workforce. with disruption to their clinical time with patients, will dental students be ready to hit the ground running? for th year dental students making the transition to foundation training, for rd and th year students downing tools and not engaging with outreach programmes and honing clinical skills, the concerns are real. i spoke to dental students mairi cameron, neha mehta and rachel jackson who couldn't help but cast their gaze towards what the profession might look like when they qualify. 'for me there is a bit of uncertainty when thinking about our place in the profession after i graduate' , mairi said. 'it was worrying reading about the number of dental practices that said they may be forced to close and thinking about the knock-on effects this could have on our cohort in the longer term. ' any significant time away from clinic will reduce our confidence in our clinical skills and treatment planning abilities and will require a considerable amount of remediation. we're very lucky at aberdeen in that we start seeing patients in our first year of study, so we have spent a fair amount of time in clinic already. i know that our clinicians and those all over the country are putting a lot of work into reorganising the next academic year. i have faith that dental schools will find a way to get their final year students to the level of a safe beginner over the next months or so. ' neha added: 'i completely agree. i am definitely concerned about my graduation and career as a dentist. these past few months have completely disrupted my time at university and this has meant that vital time on clinic has been lost. the university are looking at evening and weekend clinics to make up for lost time and bring our skills back up. however this might not be feasible as we have missed a whole term of teaching and so they are looking at lowering requirements to take finals. this concerns me because upon graduation i might have less clinical exposure and lower skills compared to other students who graduated not being affected by covid- . although this pandemic might not have affected my chances of graduation i might be at a disadvantage and find it harder to cope during my future career. ' 'right now i am more short sighted as my concerns are focused on a lack of clinical exposure and simply becoming a safe beginner' , rachel explained. a full remote replacement for the clinical application of theoretical knowledge and skill has yet to be created. not having patient contact to build relationships and the ability to transfer theory and practical skill is fundamental in the transition from non-clinical to clinical practice. for all the blended learning and online resources etc regardless of stage we now find ourselves back in the lecture room. the quality of online remote learning will now dictate the learners' development until face-to-face practical teaching resumes. it can be achieved though. unique problems such as this require unique solutions and despite the initial stress for staff and students, it is an amazing opportunity to really study and modernise the delivery of a dental curriculum moving forward. ' lauren believes the lack of clinical development could be a real issue in the years to come. she said: ' although webinars and online development has played a key role since the beginning of lockdown, i have been concerned about the restrictions leading to a lack in clinical experience. i know that dental schools and postgraduate schemes are working extra hard and coming up with innovative ways in which clinical experience can be gained. the need for preparation has increased. ' alice echoed lauren's concerns about clinical competencies and pointed to some resources that may help to fill the void. 'meeting the total requirements for procedures such as molar endodontics and extractions to ensure successful progression to finals is challenging enough as it is' , she told bdj in practice. 'that's why i feel now is the time to capitalise on the advancements made in digital education i.e. e-learning, haptic simulation and distance learning. technology has advanced rapidly over the last decade and many clinical techniques can now be taught, practiced and assessed virtually or remotely via dental simulators i.e. moog simodont dental trainer, haptel training system. this technology utilises haptic virtual reality simulation for sensorimotor skill acquisition. as many of these systems do not require an assessor or patient to be present, social distancing guidelines can be followed and clinical skills improved, without risk of transmission. i feel there is scope to modify the current techniques used in dental education to make up the shortfall in clinical experience that students have lost as a result of covid- . as many of these technologies are already utilised within the dental curriculum, emphasis on further resources for remote learning should be and are being facilitated for dental students. ' natalie added while clinical development was clearly an issue, deeper concerns lie ahead. 'besides being an able clinician ready to treat patients, i also worry about their wellbeing. concerns about their future careers, with the dental landscape looking completely different to what they expected when they began dental school, will surely put a lot of pressure on them and with much of their training now being delivered virtually, there is a risk of students becoming isolated. 'support must be in place to address not only students' learning, but addressing their health and wellbeing needs. ' in april research by the bda suggested % of practices reported that at the time they could only maintain financial viability for a maximum of three months, with those providing predominantly private care worst affected. while the nhs side of practices have been offered some support by government, the bda has warned that if those practices with a greater reliance on private work go under whatever service remains will be unable to meet patient demand. in scotland following confirmation from first minister nicola sturgeon that services would recommence from june, the bda issued a warning that a combination of higher costs and lower patient numbers could prove fatal for services in scotland. shortages of ppe are expected to place limits on patient numbers. while the authorities recently distributed more than three million individual items of ppe to dental practices, volumes are only sufficient to enable practices to see around patients a day. the assembly committee for health in northern ireland were warned to expect similar outcomes if government inaction persisted. prior to the pandemic recruitment was already facing a crisis, and there are no doubts this will only serve to elevate concerns for job seekers and recruiters. natalie suggested that while many of the young dentists she mentors and coaches are worried about their career options, the situation will be dictated by those practices who survive the pandemic. 'it is difficult to say, with the risk of some practices not surviving through the pandemic, this could mean associates and other members of the dental team not having steady work. on the other hand, i suspect that with reduced capacity to see patients at the same rate as before covid- , there will be a call to work longer hours or on a shift pattern which could increase demand for associates and worsen the recruitment crisis. 'i think that we need to remain vigilant to the possible risks to our professional careers during this time and in the future; the 'new normal' isn't just going to be isolated to our supermarket trips, but to our working lives and career paths looking into the future. ' alice suggested that while the recruitment sector will be hugely affected, it remains to be seen whether that will be for good or for bad. 'covid- will obviously change the profession -perhaps indefinitely -but we are arguably fortunate that there will always be a need for dentists, even more so now as a result of the backlog of patients not seen due to lockdown. whether this will be in in a positive or negative way is dependent on how the remuneration system is restructured, the cost/availability of ppe, the capacity for practices to accommodate new patient workflow and the government social distancing guidelines. all of these factors are liable to change and by no means an extensive or exhaustive list. 'it must be acknowledged that the delivery of services, both in the nhs and private sectors, will need considerable modification. patient workflow capacity, the uda remuneration system and provision of elective aerosol generating procedures are particular areas where changes must be made in order to comply with covid- guidelines. i feel adaptability and resilience are key areas of professional development to focus on during these uncertain times. although the future remains uncertain, i like to think the pandemic has given us the chance to start afresh and the opportunity to address the shortfalls in the previous system. ' the risk of infection to professionals in vulnerable groups i.e. pregnant, underlying health conditions, may deter return to work completely. the capacity for practices to accommodate both patients and dentists in a socially distanced environment may force clinicians to seek employment elsewhere, work part-time or between a number of establishments. the pressures of providing private dentistry may increase treatment prices for patients and/or the variety/modality of elective options available. we may see shifts in recruitment in both primary and secondary dental care, with some individuals opting for the stability of a set salary. i find it almost impossible to predict in the current circumstances, and while that may not sound optimistic, i would encourage young dentists not to be disheartened or concerned, but to embrace the opportunity for change, leadership and integration of new digital technologies into all aspect of the profession as we forge what 'new' will look like. ' the watermark of concern runs through neha and mairi too. mairi said: 'i imagine if dental practices with vt trainers are forced to close then it's possible that there will be fewer jobs for new graduates. i'm also aware of the financial blow that covid- has inflicted. i worry that dentists may be forced to reduce their nhs work and increase private work to keep their businesses viable, leaving some of the most vulnerable patients without dental care, and possibly some newly graduated dental students without vt posts. again, it's the uncertainty. ' neha added: 'when i graduate i feel like there will be fewer jobs available. many surgeries may have fewer dentists as they cannot afford it and therefore this increases the competition for jobs. my main concern is that after my vocational training year, practices will be less inclined to hire a newly qualified dentist compared to one with lots of experience due to the need for time efficiency in this current climate. ' while she understands the concerns of neha and mairi, according to lauren, the enforced break may have provided the opportunity for many to reassess career paths and choices. 'yes, in the short term it may seem that there are fewer opportunities for young associates' , she said. 'yet i know that most are using this period to step back think hard about how they want their career to progress. it's an opportunity for some to be able to make brave decisions that may take them in a direction they may not have previously considered. salaried positions may become more attractive going forward as they could offer more stability and peace of mind. if you have ever felt like diversifying your skills or your portfolio then the time is now for finding support and making enquiries. ' the mental health event identified that a range of patient-related factors were the main stressors for dentists, but the bda's research found that, while dissatisfied patients remained the second greatest stressor, fear of complaints and litigation was now the main factor. the risk of making mistakes, red tape and bureaucracy, and concern about the gdc were also leading causes. it is without a doubt the situation the world finds itself in, but red tape and bureaucracy are only likely to increase. patients will be fearful of catching covid- from their dentist. what happens if a patient complains to the gdc that their dentist was responsible for them developing covid- ? where does the burden of proof lie for starters. which makes you think that during the period of inactivity, the gdc may do something to ease the burden on their financially stretched, hugely stressed registrants. that did not happen. in an update to registrants on may, gdc chair bill moyes wrote: 'the impact of the covid- pandemic continues to have a significant effect on our lives. i am very aware that the effect of the suspension of routine dental care and services is severe and that it has prevented you providing the patient treatment and care you want to -and in some cases has caused financial difficulties. we have been ' it is without a doubt the situation the world finds itself in, but red tape and bureaucracy are only likely to increase. patients will be fearful of catching covid- from their dentist.' asked whether the gdc could respond by making changes to the annual retention fee (arf) paid by all dental professionals or by introducing an emergency payment by instalments scheme. the council has thought carefully about the options available to us, but we have decided not to make changes to the arf levels or to introduce a payment scheme. these are not decisions we have taken lightly, and i know they won't be welcomed by some of those we regulate, so i want to be clear about the reasons why we have made them. the work we have to do, which is laid down in law, has not fundamentally changed. we are required to remain financially stable and to meet our statutory obligations to ensure the public are protected and confidence in the professions is maintained. nearly all our income comes from the arf collection. by revising our regulatory approach and increasing our efficiency, we have been able to secure greater value for money and reduce the arf -and we hope to continue along this path. but we don't want to make changes now that we can't sustain, and which might lead to inefficiency and increased costs in the future.' as you can imagine, at a time when income had been reduced to zero, this decision was met with universal dismay. what kind of shambles are they running not to even consider payments in installations? did they make use of government money to furlough staff? yes they did, and yet in a clarification on this, the announcement read: 'that is why council decided that at present the level of the arf should not change. ' no mention of the possibility of instalments, which is why in a letter to moyes, bda chair mick armstrong stated: 'it is a great shame that our regulator, who prides itself on making significant improvements to its way of working, wants to work collaboratively with the profession, and whose finances include a significant budget operating surplus and significant reserves, cannot see how positive such a move would have been, and how negative its absence is. ' as always, the impact will be greatest on the most vulnerable of the profession: new graduates, many of whom have lost their part-time jobs; young dentists leaving dental foundation training and potentially struggling to find their first associateship; and dental care professional colleagues who are significantly affected by the closure of practices and the expected lengthy return to the provision of dentistry over the coming months. 'it remains a matter of fact that a relatively easy change that is within the gdc's power and would have had a profound positive reaction amongst the professions it regulates -unlike so many other possible positive changes where 'inflexible legislation' is cited as the reason for its lack of agility -is not forthcoming.' it is moves like this that do nothing to improve the patchy relationship the profession has with them. yes, they have made great strides throughout recent years, but more can be done. as alice suggests, the profession already has enough on their plates. ' as a profession, we have been put under a huge amount of emotional, financial and clinical stress. this is on top of the normal anxieties that exist whilst living through a global pandemic. the gdc must recognise and appreciate that this will inevitably have some influence on our performance as professionals. 'there have been periods where guidance has not been available, unclear or contradictory, putting clinicians in the impossible situation of trying to work within the best interests of their patients, whilst ensuring the safety of their staff and themselves. i hope the gdc takes this into account when investigating potential complaints about dental professionals during this period. 'they must also realise that as the quality of dental education has been impacted, i feel they should offer extended support to newly qualified dentists, who are now entering an uncertain professional environment with less clinical experience that would have been ordinarily obtained. after all, we are all human and we do make mistakes. ' i asked roz how covid- stresseson top of pre-pandemic stress -would be supported by the bda and where people can go for support. 'the mental health and wellbeing report and action plan has just been published and shared with all the attendees. while the focus has changed to how we support our colleagues at this difficult time, we will return after the acute phase of this pandemic to some of the important long-term objectives in that report. 'in the meantime, the bda are doing all we can to support the wellbeing of dentists and their teams by sharing resources, signposting, webinars and of course the offering with the award winning health-assured, which is available to all levels of membership, including students. the bda benevolent fund does amazing work every day, supporting those who are in financial difficulty and is open to all dentists and their dependants. 'for me, the revolution of online platforms to meet professionally, personally and clinically will be a lasting change, and one which will also benefit the planet. i would also like to think, as a society and profession, we have learnt how much we rely on each other, and how showing support and encouragement within dentistry and to all of society, is key to us all living and working well. ' we have talked about hills and potholes in this marathon of life. this pandemic is our everest. i remember exactly where i was when, i heard president kennedy had been shot, even though i was only seven years of age. for seven-year-olds now and everyone else, this will be a key milestone in our lives. personally, i don't think life will ever be quite the same again. ' ◆ news release: bda blasts gdc as arf remains unchanged during covid crisis campaigns: tackling stress in dentistry you can get mental health and wellbeing support information and advice from: ae the bda benevolent fund: www.bdabenevolentfund.org.uk/ ae dentists' health support programme: http:// dentistshealthsupporttrust.org/ ae health assured: https://bda.org/ health-assured https://doi.org/ . /s - - -x key: cord- -gi mug p authors: montesi, michela title: understanding fake news during the covid- health crisis from the perspective of information behaviour: the case of spain date: - - journal: nan doi: . / sha: doc_id: cord_uid: gi mug p the health crisis brought about by covid- has generated a heightened need for information as a response to a situation of uncertainty and high emotional load, in which fake news and other informative content have grown dramatically. the aim of this work is to delve into the understanding of fake news from the perspective of information behaviour by analysing a sample of fake news items that were spread in spain during the covid- health crisis. a sample of fake news items was collected from the maldita.es website and analysed according to the criteria of cognitive and affective authority, interactivity, themes and potential danger. the results point to a practical absence of indicators of cognitive authority ( . %), while the affective authority of these news items is built through mechanisms of discrediting people, ideas or movements ( . %) and, secondarily, the use of offensive or coarse language ( . %) and comparison or reference to additional information sources ( . %). interactivity features allow commenting in . % of the cases. the dominant theme is society ( . %), followed by politics ( . %) and science ( . %). finally, fake news, for the most part, does not seem to pose any danger to the health or safety of people – the harm it causes is intangible and moral. the author concludes by highlighting the importance of a culture of civic values to combat fake news. the covid- pandemic of is leaving a profound wound in our society, and many think that our lives will never be the same again, with implications at all levels, including for library and information services. the avalanche of fake news and hoaxes that has accompanied the health crisis since its very beginning has converted an information issue into a topic of public opinion and debate, with pressure on the library community to give a satisfactory answer to the problem of how to recognize truthful and useful information (xie et al., ) . explicit actions against disinformation have been taken since the electoral campaign for the us presidency, often in the form of guidelines and recommendations, whilst the library community has been debating about possible solutions to a problem that, sullivan ( ) argues, we do not yet fully understand. so far, libraries have responded by reaffirming traditional library values and, as an immediate solution to what has been called an 'infodemic' (marquina, ) , the international federation of library associations and institutions ( ) updated its eight-step 'how to spot fake news' checklist on march , recommending additionally the exercise of critical thinking as an essential competence in media literacy. the novelty of this new avalanche of fake news goes hand in hand with the novelty of the health crisis caused by the covid- pandemic, which has converted fake news and information into a matter of social concern. many social actors have contributed to a heated debate that has paralleled the health crisis, including the spanish national police ( ), which, on march , announced on its website the publication of a 'guide against fake news'. this guide, in the style of the international federation of library associations and institutions' directions, recommends, among other strategies to check the veracity of information, relaunching google searches, comparing the information found, being suspicious, verifying the author and to avoid sharing. apart from the police, since march many spanish professionals from different sectors have intervened to address the issue and encourage the population to break the chain of dissemination of clearly adulterated news. in his blog, the psychologist soler sarrió ( ) recommends googling possible fake news and applying common sense. according to soler sarrió ( ) , fake news aims to provoke fear and panic among the population, while borondo ( ) , from the newspaper el correo, stresses that it cannot only cause internet saturation, but could even put lives at risk. from the university of barcelona, vincent ( ) highlights the manipulative purposes of fake news, which seeks to scare, confuse and fuel divisions among the population, encouraging distrust of information from the government and other official sources. emotional manipulation has been highlighted by newtral ( ) as well, a journalistic website that is devoted to selecting and filtering information. however, the real social implications of the problem emerged from a survey by the centro de investigaciones sociológicas published on april. a sample of spanish citizens was asked whether fake news should be prohibited and only official sources on the pandemic be permitted, and % of the respondents agreed that 'it would be necessary to limit and control the information, establishing only one official source of information'. this caused protests against an alleged attack on the freedom of the press (marcos, ) , though it also threatens the library principle of unfettered access to information (sullivan, ) . although it is questionable whether fake news alone can generate division and social unrest, since, according to some sources, they would rather thrive on it and proliferate it in times of difficulties (tandoc et al., ) , it clearly introduces manipulative intentions in the consumption of information. its purposes are both financial, seeking to increase the number of visits and clicks and consequently advertising revenues, and ideological, usually discrediting certain ideas and people in favour of others (bakir and mcstay, ; tandoc, ) . lazer et al. ( lazer et al. ( : define 'fake news' as 'fabricated information that mimics news media content in form but not in organizational process or intent', which differs from both 'misinformation' -that is, false or misleading information -and 'disinformation' -that is, false information that is disseminated intentionally to deceive people. bernal-triviño and clares-gavilán ( ), citing the european commission, indicate that it would be more appropriate to speak of 'disinformation' because the term 'fake news' has been used to discredit the critical stance of certain information media that published truthful information. according to bakir and mcstay ( ) , disinformation consists in deliberately creating and disseminating false information, while misinformation is the practice of those who, without being aware, disseminate false information -a phenomenon that has been little studied, the authors explain. according to tandoc ( ) , fake news can be considered a type of disinformation, whose main features include falsity, the intention to deceive and the attempt to look like real news. rubin ( ) reiterates that the difference between misinformation and disinformation is intentionality, with both behaviours being supported by the highly technological affordances of our society. social networks and online communication, together with the financial reasons mentioned above, are the basic foundations for the dissemination of false news (blanco-herrero and arcila-calderón, ). according to rubin ( ) , who applies an epidemiology-based model to the spread of fake news, social networks act as a means of transmission of the pathogen -the false news -whereas information-overloaded readers, with little time and without the appropriate digital skills, are the carriers. the warnings of the world health organization ( : ) go along the same lines, and this institution has been speaking of epidemics of rumours or an 'infodemic' in reference to 'the rapid spread of information of all kinds, including rumours, gossip and unreliable information', as a new threat to public health. among the other motivations for spreading disinformation, bakir and mcstay ( ) underscore the affective dimensions of fake news, which rouses strong emotions, such as outrage, and takes advantage, among the other characteristics of online communication, of anonymity. tandoc ( ) , in order to explain people's reasons for believing in fake news, discusses 'confirmation bias', or the inclination to believe in information confirming pre-existing beliefs, and 'selective exposure', or being exposed to content and information sources that are more attuned to one's preexisting attitudes and interests. however, according to pennycook and rand ( ) , who measured the propensity to engage in analytical reasoning in a sample of participants who had been exposed to a set of fake and real news items, it was the participants' willingness to engage in analytical thinking rather than confirmation bias that may have explained the difference in their ability to discern fake news from real news. in this study, analytical thinking allowed the participants to reject or disbelieve even politically concordant fake news articles. a lot has been written during the covid- crisis of in an attempt to fight against disinformation. an important part of the research has focused on the analysis of all kinds of information spread via social media (cinelli et al., ; ferrara, ; singh et al., ) , whilst others have suggested interventions for improving news and science literacy as empowering tools for users to identify, consume and share high-quality information (vraga et al., b) . the present contribution aims to understand the phenomenon of fake news from the perspective of information behaviour, pointing to uncertainty as a notable emotion in the context produced by the covid- health crisis. all models of human behaviour in the consumption of information emphasize uncertainty as the factor that triggers the search for information itself, although traditionally it has been conceptualized more as a cognitive than an emotional trigger, at least in certain literature that has underscored the attributes of individuals above context and sociocultural frameworks in the study of information behaviour (pettigrew et al., ) . since the s, information behaviour has been studied in the framework of communicative processes and in connection with contextual factors of a social, cultural and ideological order, among others, including values and meanings (pettigrew et al., ) . the evolutionary perspective of spink and cole ( ) also refers to the environment or context when they point to the ability to obtain and exchange information as intimately linked to human survival. in the theory of spink and cole ( ) , a behaviour of a constant searching for and collection of information from the environment, together with the architecture of the brain, has allowed the adaptation and survival of human beings. human beings have been collecting and seeking information constantly, and not always consciously, in order to adapt to their environment and survive. from this perspective, informationrelated behaviour appears as an instinct, not always conscious, and a basic need of all human beings. applied to the situation produced by the covid- crisis, it can be said that the great uncertainty and the strong emotional charge regarding health, economic and social issues have created a heightened need for information as a strategy to cope with and adapt to an unusual and unexpected situation. uncertainty as well as other emotions have been given attention in the study of information behaviour as influencing factors that interact with cognitive factors. in the kuhlthau ( kuhlthau ( , model, emotions such as uncertainty, anxiety, optimism or worry fluctuate according to the different stages of the information-search process, accompanying the respective cognitive and decision-making processes. nahl ( ) describes the synergy between cognition, emotions and the sensorimotor system in interactions with information technologies, explaining that adapting to environments with high information density implies a 'load' in all three dimensions. in nahl's ( a nahl's ( , b theory of affective load in human information behaviour, affective processes interact with cognitive processes, providing the energy and motivation necessary to adapt to information technologies, for example, or regulating certain decisions, such as those regarding whether to use the information or not. even in these models where emotions and other non-cognitive factors are assigned a role in information behaviour, decisions are made at the level of thinking and cognition. however, information decisions can also be made based on non-rational criteria and guided by emotions, corporeality and affect (montesi and Álvarez bornstein, ) . these non-rational factors guide people's judgement about the information they consume on a day-to-day basis and in situations of a lack of information and knowledge, which occur either because people enter specialized fields or because science and experts cannot always provide all the answers, as in situations of conflict between different sources of information -a phenomenon that has been studied in health information (montesi, ) . in the initial stages of the covid- crisis, and even later, experts and science were not able to provide all the answers that society expected. at the same time, uncertainty and the need for information were great, creating an important information gap in which other sources of knowledge came into play. research on the search for health information teaches us that the information of health professionals, endorsed by health authorities, is usually complemented by what is called 'experiential knowledge' -that is, knowledge acquired as a consequence of experience (either personal experience or other people's experience) in relevant situations (montesi, ) . this type of knowledge is usually exchanged when interacting with people (also on social media) and is closely related to social support, as it contributes to explaining and attributing meaning to the experiences that are being lived (barbarin et al., ; rubenstein, ) . experiential knowledge is especially valuable when facing situations of uncertainty and adaptation, not only for individuals but also for communities. baillergeau and duyvendak ( ) argue that 'experiential knowledge', as an alternative to expert knowledge, can guide policy responses in situations of high levels of uncertainty, specifically in the field of mental health policies. an important role is also recognized for experiential knowledge in climate change adaptation policies, where 'local knowledge' or 'indigenous knowledge', as it is referred to in this area, covers all the knowledge developed over a considerable period of time and shared by a community with respect to a specific locality. by its nature, local knowledge concerns adaptation mechanisms to changing environments, for both climatic and other factors, at the household and community levels (naess, ) . experiential knowledge, as an alternative to official and authoritative knowledge from health systems, contributes to people being capable of making decisions about their health, and health literacy is, according to samerski ( ), a social practice based on different sources and forms of knowledge, co-produced within the framework of social relations. despite the fact that it can guide in situations of uncertainty and adaptation, and that it empowers people to manage their health, experiential knowledge is still not recognized as evidence, and expert knowledge continues to condition the discourse and definitions of health and social problems (popay, ) . in short, during the covid- health crisis, fake news has been spread in a context of great uncertainty and emotional load that has generated a heightened need for information as a mechanism for understanding and adapting to an unprecedented and threatening event. the urgency of the situation has pushed us to look for quick solutions as a response to fake news, misinformation and disinformation -such as guidelines in bulleted points or automatic checks via google or other information 'authorities' such as factcheck.org (bernal-triviño and clares-gavilán, ) -and a significant proportion of the spanish population surveyed by the centro de investigaciones sociológicas ( ) supported the idea of a single official information source. in the end, the wide spread of false news calls into question all the knowledge that is produced outside official communication channels, as well as the rights of citizens to exercise their judgement on the information they consume. delegating decisions on information to authorities, whether health, scientific or others, is a common choice to assess trustworthiness and credibility, but during the covid- crisis it has been more pronounced and potentially harmful, as it might suppress all other sources of information, not only news media. saunders and budd ( ) remind us that, in library education, the credibility of information sources is assessed by looking at the credentials of who has produced them and their publication track record, reinforcing existing biases in the production of knowledge, including gender bias, in favour of institutionalized knowledge, and underestimating the need to train future library and information professionals on the evaluation of scientific information and contents. in other words, rather than checklists or predefined recipes for fighting fake news, misinformation and disinformation, it is necessary to develop critical thinking skills to apply to the content and information to which we are exposed on a daily basis. vraga et al. ( a) propose an initiative of news literacy combined with expert corrections of misinformation. however, fact-checking initiatives intended to debunk fake news might also fail as a strategy, as most people might ignore evidence or even continue to hold onto their pre-existing ideas, even after exposure to it (tandoc, ) . in addition, monopolizing control over information might have undesirable consequences and pave the way for censorship (sullivan, ) . it is also important to defend the legitimacy of information and knowledge that is acquired and shared outside institutionalized settings and as a result of experience, as it might be a meaningful complement to scientific knowledge, according to the vast research on health information behaviour. on the basis of these assumptions, better knowledge of disinformation is needed not only to improve research into the automatic detection of anomalous information (zhang and ghorbani, ) , but also to avoid fast and potentially harmful solutions. such research addresses the following questions in particular: does fake news rely on experiential knowledge? how does it manage to appear 'authoritative' to people who contribute to its dissemination? to what degree is it harmful? characterizing and understanding false news can help us to recognize and reject it based on the exercise of critical thinking. with this objective, in this work a set of false news items spread during the covid- crisis in spain is analysed. the sample of fake news analysed was obtained from the maldita.es website, a project that is part of the international fact-checking network initiative, which has been collecting fake news since (bernal-triviño and clares-gavilán, ). the methodology, on the basis of which it is established whether a news item is considered false, is described on the website (maldita.es, ) ; it focuses mainly on the verification process while omitting details regarding the news selection process. all the fake news is discussed thoroughly on maldita.es and refuted on the basis of additional public sources. in total, fake news items were classified. as of april , when the analysis of fake news was initiated, the site had collected news items that had been produced during the covid- health crisis alone. by the end of april, when the classification reached its end, the collection numbered almost items and was continuing to grow. the fake news on maldita.es does not follow a chronological order, and consecutive chunks of news were classified at the beginning, at the end and in the middle of the series during the month of april. the fake news collected from maldita.es on april included all false news reports about covid- , with the exception of three, which the intelligence centre against terrorism and organized crime ( ) of the ministry of internal affairs collected in a report that was published on march , providing a certain guarantee of coverage of the main hoaxes that were spread in the course of the health crisis. in order to classify the news against a set of quality criteria, i first looked at the literature on health-information seeking and the criteria that come into play when evaluating health information. among the elements that influence the quality of health information on the web, sbaffi and rowley ( ) highlight the website's design, the authority of the person/institution responsible for the site and the possibility to make contact, as well as the availability of other channels of interaction. similarly, zhang et al. ( ) emphasize the importance of factors related to web design -in particular, interactivity and the possibility of exchanging information with other people, expansion through social media, the presence of an internal search engine, multimedia documents and the availability of explicit disclaimers. at an operational level, the work of sun et al. ( ) was also taken into account. they define quality as 'fitness for use' -that is, quality information must serve the user's needs -and, in order to 'measure' it, sun et al. ( ) differentiate 'criteria', or rules, that people apply to information objects to determine their value -reliability, experience, objectivity, transparency, popularity or understandability, among others -from 'indicators' -that is, perceptible elements of the information objects that allow their quality to be determined. the set of indicators that sun et al. ( ) propose is deployed in three broad sections. indicators related to content cover both the information and the presentation, and include aspects such as themes and concepts, writing, presentation, references, authorship, audience, current events and the presence of advertisements. design-related indicators refer to the appearance and structure of the website or application, and the possibilities of interaction it provides. finally, the indicators related to the source include who creates, hosts and distributes the content, and the site typology, as well as its popularity and other systems' recommendations. unfortunately, many of these indicators are not applicable in this research. usually, fake news is spread outside of a website's context and as direct falsifications of official documents or informal communication devices such as tweets or social media accounts, among others. for this reason, many information literacy programmes addressing fake news may be ineffective (sullivan, ) , whilst artificial intelligence can be used to digitally manipulate video and audio files to deliver what has been called 'deep fakes' (tandoc, ) . from this literature on the evaluation of health information, i have retained two concepts -authority and interactivity -which i have measured as explained below. the concept of cognitive authority is one of the most studied in information-related behaviour (rieh, ) . as neal and mckenzie ( ) explain, currently the 'cognitive authority' of an information source is conceived as the result of social practices that allow a certain community to negotiate what counts as an authorized source of information. citing the framework for information literacy for higher education of the association of college and research libraries, saunders and budd ( ) add that cognitive authority is not only constructed, but also contextual, depending on the information needs of the situation, and that it covers not only traditional indicators of authority, such as subject expertise and societal position, but also lived experiences, such as those shared on blogs or social media. with reference to experiential knowledge, a second affective dimension of authority comes into play, which builds on the subjective properties of the information being shared, such as appropriateness, empathy, emotional supportiveness and aesthetic pleasure (neal and mckenzie, ) . as lynch and hunter ( ) point out, cognitive authority alone might be insufficient to deal with misinformation, and reflection on each individual's social and emotional factors might cast light on the dynamics of affective authority. according to montesi and Álvarez bornstein ( ) , from an affective point of view, decisions about information also rely on non-rational and not always conscious indicators originating from senses, emotions and intrapersonal knowledge, especially when decisions need to be made in situations of conflict among different information sources and points of view. following neal and mckenzie ( ) , the affective authoritativeness of experiential information sources rests on the account of the experience itself and its details, the similarity of the experience narrated with the reader's experience and, finally, the ability to comfort or inspire that personal experience provides over mere information. although they do not explicitly mention the affective dimension of authority, hirvonen et al. ( ) , who analyse a health forum for young women, add that the reliability of experiential knowledge is judged on the grounds of an array of elements, ranging from data related to the author to the way of arguing and tone (including language and style), the veracity or coherence with the reader's prior knowledge, and verification through comparison of various sources. it is important to differentiate this 'affective authority' of the content being disseminated from the affective authority of those who disseminate information, including false news, since, as montero-liberona and halpern ( ) point out, much false health news comes precisely from acquaintances and trusted people. in the classification of fake news, i have taken into account aspects that were relatively easy to detect which could allow a classification out of context, pointing to properties of the news that might have convinced the reader. specifically, and after a first informal browsing of the set of news items being classified, i have tried to operationalize the above concepts of cognitive and affective authority in the following way. regarding cognitive authority, it has been determined whether the information provided in the fake news ( ) derived from direct and firsthand experience, justified in the way the studies mentioned above describe (experiential knowledge); ( ) relied on subject expertise without institutional endorsement or other types of endorsement (the name, surname and professional qualification were provided and no more); or ( ) derived from subject expertise endorsed by an institution or a publication track record. additionally, i coded ( ) direct falsifications and ( ) the total absence of indicators of cognitive authority. capturing the affective component of authority based on the news itself and out of context is more difficult. in order to be able to locate cues of affective authority, i exploited, on the one hand, the concepts of fake news being used to discredit opponents (bakir and mcstay, ; tandoc, ) and of conflict among information sources as a condition for making 'affective' decisions about information (montesi and Álvarez bornstein, ) . on the other hand, i used some of the strategies described in hirvonen et al. ( ) to weigh experiential knowledge, in particular those pertaining to language and the comparison of sources. as a result, the following elements have been recorded: ( ) whether the news discredited people, ideas or movements in favour of others that were supposedly common to the recipients of the hoax; ( ) if coarse or offensive language was used; and ( ) if additional sources were mentioned or opportunities for further study were offered. i understood that the comparison of sources denotes a legitimate and genuine intention to transfer the knowledge acquired through personal experience. these were considered the easiest and most objective elements to detect, bearing in mind that it was not always possible to access the primary source. as mentioned previously, the literature on health-information seeking on the web points to interactivity as an important element to consider when evaluating information. according to sun et al. ( ) , interactivity is all the possibilities within a site to communicate with the system or other users, and to adjust content to consumer needs. this broad definition covers a varied range of features, such as internal search functions, devices for commenting on content and allowing user input and information exchange, multimedia content or personalization tools. the breath of the concept makes it difficult to use interactivity in fake news classification, especially if we consider that fake news is often disseminated outside of a website and that it is often ephemeral in nature. indeed, the literature dealing with the topic of interactivity supports a complex conception of it. oh and sundar ( ) differentiate 'modality interactivity', or 'tools or modalities available on the interface for accessing and interacting with information' ( ), from 'message interactivity', or 'the degree to which the system affords users the ability to reciprocally communicate with the system' ( ). yang and shen ( ) employ a meta-analysis to determine the effects of interactivity on cognition (as knowledge elaboration, information processing and message retrieval), enjoyment, attitude and behavioural intentions. the inconsistent conclusions they reach, pointing to a positive effect in all dimensions except cognition, suggest that interactivity might influence users' experience via two different routes: a cognitive route and an affective route. yang and shen ( ) conclude that, even if web interactivity does not support user cognition, it might raise affective responses, such as enjoyment, developing as a consequence favourable attitudes and behavioural intentions. according to oh and sundar ( ) , actions such as clicking, swiping and dragging allow users to exert greater control over the content and to feel absorbed and immersed cognitively and emotionally in it. without systematically processing the website's message, users may express a more positive attitude towards its content by feeling absorbed in interactive devices. although it might be difficult to identify interactivity clearly, it appears to be related to the affective dimension of authority that i discussed earlier, and it is therefore pertinent to devote some attention to it in this research, even if with limitations. basing the analysis exclusively on the news does not allow us to understand user perspectives on interactivity (sohn and choi, ) , and it is impossible to measure for fake news features such as search capabilities or personalization tools. all fake news is, to a certain extent, interactive, as it is precisely thanks to certain interactivity features that it goes viral. in this classification, i adopted a simple conception of interactivity and recorded whether the interactivity supported was simply one-click interactivity (forward, share, hashtag or like) or interactivity that at least allowed a certain degree of interaction and dialogue through the comments option. one-click interactivity covers all audio or text messages, images and videos sent via whatsapp, television programmes, and certain news published in web magazines and media that did not allow commenting. when it was not possible to determine whether the news allowed commenting, interactivity was coded as 'impossible to determine'. i have classified fake news into three themes: politics, science and society. although it tends to be predominant in politics, health fake news is also common (montero-liberona and halpern, ) and it was expected that, in the covid- crisis, it was being widely disseminated. in this study, health news was classified under science. a previous analysis of fake news collected from maldita.es revealed that, out of news items, most had politics as the main theme ( %), whilst the rest were distributed among people ( %), immigration and racism ( %), gender ( %) and science ( %) (bernal-triviño and clares-gavilán, ). i decided to remove 'people' as a category because many fake news pieces specifically attack people in the world of politics and thus have a political intention. according to tandoc et al. ( ) , in most cases, fake news is ignored and does not lead readers to further action, except for in some anecdotal cases, although concerns have been expressed about its ability to influence election results and confuse readers. however, in some exceptional cases, it can lead to extreme episodes of violence (tandoc, ) . in addition, much fake news has a certain sense of humour -something that can convince us of its harmless nature. however, the real danger it can result in is unknown. therefore, based on the information provided by maldita. es and complementary information searches, i attempted to determine whether fake news could result in potential danger to people's health or safety. all of the news that maldita.es had collected as fake was treated as such, with a few exceptions. phishing emails were excluded, as usually they are not intentionally spread in the same way as fake news, and so were some clear mistakes, such as an audio message from a doctor recorded for her family when leaving a meeting, which had been spread virally. i understood that these cases were not false information. maldita.es has also collected as fake news interpretations of information that are not always clear. this was the case, for instance, for the controversy about whether children were allowed a walk in italy or not between the end of march and the beginning of april . all of these cases were included in the analysed cases but they were not classified. in what follows, descriptive statistics are presented for authority, interactivity, themes and potential danger. in some cases, the possible association of some news features with others was tested by applying the chi-square test, such as the association between the use of offensive and coarse language and the theme of the news item. when the null hypothesis could be rejected, it is indicated in the text. the data was processed using excel and ibm spss statistics. table shows that the sample of classified fake news presents, in most cases, no cues of cognitive authority. in more than half of the cases ( . %), the information provided is not based on personal or professional experience. in . % of the news items, the authors introduce themselves by giving their name, surname and professional qualification, but do not mention any institutional affiliation or other type of endorsement. clear falsifications account for . % of all cases. the falsified news included all the alleged declarations of well-known people -such as bill gates, noam chomsky or pope francis -counterfeit tweets or other social media content published by major news media outlets, the spanish national police, ministries, or other departments of local and national government. in only instances ( . %) did i find some type of endorsement. this was the case with journalists publishing incorrect information, which was often rectified in news media outlets by members of parliament or experts such as thomas cowan, the author of several books. regarding affective authority, . % of the news discredits people, ideas or movements, whilst . % does so using coarse or offensive language. although in . % of the cases other sources are mentioned or referred to, often these sources do not exist as a result of falsifications or their removal. even so, this strategy may be enough to confer a certain affective authority on the news. in . % of the cases, the hoaxes use one-click 'interactivity', such as forward, share or hashtags. in . % of the cases, comments are also allowed, especially from twitter accounts or for youtube videos. many of the comments had been disabled on the date i accessed the news (especially on youtube). where the comments had not be disabled, often it was mentioned that the news was false or incorrect (see table ). one-click interactivity occurs more frequently when the hoax is a direct falsification (pearson's chi-squared = . , df = , p < . ) and when it does not compare or refer to additional information sources (pearson's chisquared = . , df = , p < . ). in the classification by theme, society accounts for . % of all cases, followed by politics ( . %) and science ( . %). all the fake news published in the category of science concerned health topics and, despite having all been published during the covid- health crisis, which should have emphasized health over the other categories, science accounted for less hoaxes than politics and society. the most common topics of the health fake news classified in the category of science included home remedies for treating, preventing or diagnosing covid- ; explanations about the origin of the virus, including the names of scientists allegedly responsible for the pandemic; vaccines; or advice regarding masks and hygiene procedures to avoid infection. popular news in politics often targeted members of the government and, secondarily, other politicians, who were accused of having preferential access to the health system's resources, breaching the lockdown or underestimating the impact of the pandemic based on the alleged evidence. all measures that limited the freedom of citizens were often misinterpreted and inflated. finally, society fake news was concerned with well-known people and companies, especially supermarket chains and social media companies; often had a racist background; showed images of animals in deserted urban scenes; and sometimes had an ironic tone (see table ). more frequently than society or science fake news, politics fake news used coarse or offensive language (pearson's chi-squared = . , df = , p < . ) and discredited people, movements or ideas (pearson's chisquared = . , df = , p < . ). as can be seen in table , it is clear that the vast majority of the news does not imply any danger to people's health or safety, since only of the news items that could be classified according to this criterion represent certain types of danger either for public safety or people's health. among the cases that were classified as potentially dangerous for health, meaningful examples include a supposed vaccine against covid- that could be used to manipulate the population, advertisements showing people offering to be infected with the virus, or the alleged minor vulnerability of smokers to covid- . on the side of fake news that was potentially dangerous for the security of people, examples include all news dealing with the impulsive behaviour of people rushing to supermarkets and stockpiling food or other commodities, which could invite people to reproduce similar behaviour. in this research, a sample of fake news items collected by the maldita.es project during the covid- health crisis in spain was classified according to the criteria of authority, interactivity, theme and potential danger. with regard to authority, no single news item was based on personal firsthand experience and only . % of the pieces were based on professional expertise supported by an affiliation or a publication track record. more than half of the sample ( . %) did not present any elements whatsoever that permitted mention of cognitive authority. in the rest of the cases, the information provided was either a clear falsification ( . %) or came from alleged professionals who, with their name, surname and professional qualification but no other endorsement, intended to contribute their knowledge ( . %). from the perspective of affective authority, hoaxes created 'complicity' with their recipients through strategies of discrediting people, ideas or movements ( . %), often using coarse or offensive language ( . %), pointing to the connection of affective responses with situations of polarization or conflict among information sources. both strategies were related to fake news whose main theme was politics. additionally, in more than a quarter of the cases ( . %), the fake news used a strategy of apparent transparency by comparing or referring to additional information sources, which probably helped to gain the trust of the recipients. as for interactivity, . % of the fake news items allowed comments and, in theory, an exchange of information with the author of the news or other people, while . % only allowed some type of one-click interactivity, such as like, share or forward. for . % of the news items, it was impossible to determine whether they supported commenting. one-click interactivity was related to falsifications more often than expected, whilst commenting was related to comparison or reference to additional information sources more often than expected, which means that interactivity features appeared to be related to different strategies of constructing authority. when authority rests on falsified author credentials, interactivity tends to be minimal -just enough to allow the spread of the news. when authority is built through a strategy of comparison and references to additional information sources, as usually happens when experiential knowledge is shared, it might support comments and, with these, a certain degree of participation. it is important to stress that most often the additional or referenced sources are also false or do not exist. what i am counting here is the act of referencing and supporting the news. research into interactivity has not be conclusive on the cognitive effects of physical and click-based interactivity (yang and shen, ), though apparently it can create significant changes in cognitive and emotional processing, as well as in attitudes and behaviours related to the information processed (oh and sundar, ) . social media per se and their interactive features do not always support real dialogue and communication, especially when they are used with political purposes (pérez curiel and garcía-gordillo, ), and even if likes or shares are often taken as indicators not only of interactivity and engagement but even of bi-directional and participative communication (sáez-martín and caba-pérez, ) . it is important to remember that, in the context of the covid- crisis, the need to consume information might have been much higher than usual, and even simple one-click actions might have allowed some kind of engagement and participation in information exchanges. cinelli et al. ( : ) , who looked at million comments and posts over a time span of days on five social media platforms during the covid- crisis, meaningfully observe that the spread patterns of questionable information do not differ from those of reliable information, concluding that 'information spreading is driven by the interaction paradigm imposed by the specific social media or/and by the specific interaction patterns of groups of users engaged with the topic'. future research should pursue a clearer definition of all these concepts and investigate how interactivity cooperates in supporting authority, on the one hand, and communication and participation, on the other. fake news items with society ( . %) as the theme outnumbered those on both politics ( . %) and science ( . %). it was surprising that science, which covered health, was the least popular subject in the middle of an unprecedented health crisis. health and politics discussions during the crisis might have followed different patterns, as ferrara ( ) explains on the basis of . million english tweets about covid- , concluding that tweets generated by bots were different from those generated by human users in that the former presented political connotations whereas the latter were concerned mainly with health and welfare issues. it might also be some feature of scientific information itself that explains this difference, such as the availability of valuable health information or the high level of specialization required to access and make use of scientific information, even in a manipulative way. scientific information is also based on peer review, which is, to a certain extent, a participative process, leading to the agreement of what counts as evidence and reducing conflict and polarization. finally, the vast majority of fake news does not result in any danger to the health or safety of people, which can lead us to consider it as harmless. indeed, some fake news is quite inoffensive. it does not cause any harm to claim that deer are trotting around in a spanish village when the video was actually shot in italy, because the images remain astonishing and worth sharing for their aesthetic value. however, taking as evidence the affective authority mechanisms mentioned above, there is some damage that disinformation might cause, which is not only intangible but also of a moral nature. sullivan ( ) insists that the problem is not the existence of disinformation itself but what it might do to our minds. the literature on the subject emphasizes that consumers of information tend to prefer information that confirms their preexisting attitudes and visions of the world, and give preference to information that is gratifying over that which calls into question their expectations (lazer et al., ; montero-liberona and halpern, ) . this phenomenon has been called 'confirmation bias' (tandoc, ) . however, i contend that this inclination towards the familiar can be conditioned by previous or prior knowledge -that is, all the information we have stored as a result of our experiences and as members of a certain society, and that we need in order to process and make sense of new information (renkema and schubert, ) . in a certain sense, it is to be expected that we prefer what is coherent with our prior knowledge and can be made sense of, even if our mental frameworks can sometimes distort facts according to socially and culturally shaped schemas of the world. perhaps, instead of correcting this natural inclination of human beings, we should correct the very concept we have of knowledge and start to include, apart from facts, values and meanings, as research into climate adaptation suggests (bremer and meisch, ) . if fake news is an indicator of social tension and divisions, as mentioned above following tandoc et al. ( ) , what it is showing, by discrediting without foundation people, ideas and movements, falsifying, and using coarse and offensive language, is a failure of civic values in contemporary society. and this does not only affect those creating the fake news, but also all those who are contributing to its dissemination. it is not enough to combat fake news from a purely cognitive angle, recommending checklists and honest expert control (rodríguez-ferrándiz, : ), or rectifying and correcting misinformation through news literacy interventions (vraga et al., b) . it is necessary to look for a solution within the complexity of human beings and our society that not only promotes critical thinking but also encompasses values and beliefs. libraries are proposing to broaden the ideological spectrum of their collections, highlighting the pluralism of the society they serve (lópez-borrull et al., ) . however, sullivan ( ) points to a tension in traditional library values that, on the one hand, aim to provide unrestricted access to information and, on the other, offer 'epistemological protection' by selecting information according to an unquestionable concept of quality. the solution to the apparently unsolvable problem of fake news probably requires a much deeper redefinition of values than simply making room for more pluralism and, according to the results of this study, affective nuances of knowledge and authority should be thoroughly explored and understood in order to take further steps in the fight against fake news. the author received no financial support for the research, authorship and/or publication of this article. michela montesi https://orcid.org/ - - - experiential knowledge as a resource for coping with uncertainty: evidence and examples from the netherlands. health fake news and the economy of emotions: problems, causes, solutions good or bad, ups and downs, and getting better: use of personal health data for temporal reflection in chronic illness uso del móvil y 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del covid- . youtube, march creating news literacy messages to enhance expert corrections of misinformation on twitter. communication research. epub ahead of print empowering users to respond to misinformation about covid- managing epidemics: key facts about major deadly diseases journal of the association for information science and technology. epub ahead of print effects of web interactivity: a metaanalysis an overview of online fake news: characterization, detection, and discussion quality of health information for consumers on the web: a systematic review of indicators, criteria, tools, and evaluation results michela montesi is associate professor at the complutense university of madrid. her area of expertise covers information behaviour, health information, and scientific communication. key: cord- -zm nae h authors: vito, domenico; ottaviano, manuel; bellazzi, riccardo; larizza, cristiana; casella, vittorio; pala, daniele; franzini, marica title: the pulse project: a case of use of big data uses toward a cohomprensive health vision of city well being date: - - journal: the impact of digital technologies on public health in developed and developing countries doi: . / - - - - _ sha: doc_id: cord_uid: zm nae h despite the silent effects sometimes hidden to the major audience, air pollution is becoming one of the most impactful threat to global health. cities are the places where deaths due to air pollution are concentrated most. in order to correctly address intervention and prevention thus is essential to assest the risk and the impacts of air pollution spatially and temporally inside the urban spaces. pulse aims to design and build a large-scale data management system enabling real time analytics of health, behaviour and environmental data on air quality. the objective is to reduce the environmental and behavioral risk of chronic disease incidence to allow timely and evidence-driven management of epidemiological episodes linked in particular to two pathologies; asthma and type diabetes in adult populations. developing a policy-making across the domains of health, environment, transport, planning in the pulse test bed cities. air pollution has become silently and hiddendly one of the most impactful menace to global health. the european environmental agency [ ] estimates that premature deaths attributable to exposure to air pollution of fine matter particles reach are about in over eu countries. the exposure to no and o concentrations on the same countries in has been around and respectively. the health threat of air pollution remain located mostly in cities. but the effects does not only limitate on wellbeing, but are also econonomical. the most vulnerable to the risks are lower income socio-economic groups that nowadays are also the most exposed to environmental hazards. air pollution indeed does not represent only a sanitary issue: it's burden reflects also in increasing medical costs. air pollution thus, is a problem can be only addressed with a strategic vision can only be addressed with long term targeted policies, majorly in urban environments. in the year itu and the united nations economic commission for europe (unece) gave the definition of smart and sustainable city as "an innovative city that uses information and communication technologies (icts) and other means to improve quality of life, efficiency of urban operation and services, and competitiveness, while ensuring that it meets the needs of present and future generations with respect to economic, social, environmental as well as cultural aspects". this definition led also in , in the united for smart sustainable cities initiative (u ssc). this open global platform responded to united nations sustainable development goal : "make cities and human settlements inclusive, safe, resilient and sustainable.", offering an enabling environment to spread knowledge and innovation globally [ ] . also the health sector has been contaminated by this vision: the increase of social networking, cloud-based platforms, and smartphone apps that support data collection has enhance opportunities to collect data outside of the traditional clinical environment. such informative explosion allowed patients to collect and share data among each other, their families and clinicians. patient-generated health data (pghd) is defined as health-related data generated and recorded by or from patients outside of the clinical areas. this data could be an important resource available for patient, clinicians and decision makers to be used by to address a current or emerging health issue, and most of it is globally wide, also if they are integrated by information coming from diffuse sensory/iot devices and manually input voluntary data reported by the patients, caregivers, or generic citizen participation bring to shared decision-making. the definitions above helps to understand the context of pulse project. pulse aims to design and build a large-scale data management system enabling real time analytics of flows of personal data. the objective is to reduce the environmental and behavioral risk of chronic disease incidence to allow timely and evidence-driven management of epidemiological episodes linked in particular to two pathologies; asthma and type diabetes in adult populations. developing a policy-making across the domains of health, environment, transport, planning in the pulse test bed cities. the project is currently active in eight pilot cities, barcelona, birmingham, new york, paris, singapore, pavia, keelung and taiwan, following a participatory approach where citizen provide data through personal devices and the pulsair app, that are integrated with information from heterogeneous sources: open city data, health systems, urban sensors and satellites. pulse foster long-term sustainability goal of establishing an integrated data ecosystem based on continuous large-scale collection of all stated heterogeneous data available within the smart city environment. pulse project is goaled on build a set of extensible models and technologies to predict, mitigate and manage health problems in cities and promote population health. currently pulse is working in eight global cities. it harvest a multivariate data platform feed by open city data, data from health systems, urban and remote sensors and personal devices to minimize environmental and behavioral risk of chronic disease incidence and prevalence and enable evidence-driven and timely management of public health events and processes. the clinical is on asthma and type diabetes in adult populations: the project has been pioneer in the development of dynamic spatiotemporal health impact assessments through exposure-risk simulation model with the support of webgis for geolocated population-based data. pulse gives finally a more wide vision of wellbeing were it is intended also in the relationship with environmental conditions. acquisition, systematization and correlation of large volumes of heterogeneous health, social, personal and environmental data is among the core and primary activities in the pulse project. the overall goal of the deployments involves deriving additional values from the acquired data, through: developing more comprehensive benchmarking and understanding of the impact of social and environmental factors on health and wellbeing in urban communities, thereby broadening the scope of public health. on this sake pulse has developed tools for end-users (primarily citizens and patients, public health institutions and city services) that leverage open, crowd-sourced and remote sensing data, through integration, enrichment and improved accuracy/reliability of risk models, to guide actions and deliver interventions aiming to mitigate asthma and t d risk and improve healthy habits and quality of life. figure shows the conceptual schema of the relationships among dataflows. pulse project focuses on the link between air pollution and the respiratory disease of asthma, and between physical inactivity and the metabolic disease of type diabetes. the risk assessment for this two pathologies comprises the evaluation respectively of: for type diabetes: behavioural risks associated (i.e. reduced exercise/physical activity at home or in public places). this is associated with higher risk of t d onset in a dose-response relationship. the assessment use unobtrusive sensing/data collection and volunteered data to collect baseline measures of health and wellbeing, and tracking and model mobility at home and across the city (including time, frequency and route of mode of transit and/or movement). for asthma: environmental/exposure risks (i.e. exposure to air pollution, especially with regard to near roadway air pollution). poor air quality is associated with higher risk of asthma onset and exacerbation. risks of diseases onset are evaluated thorough risk assessment models, that in pulse are biometric simulation models that predict the risk of the onset of the ashtma and diabetes in relationship to air quality. the models has been developed by chosen ones from a literature review of the prediction models of type diabetes (t d) onset and asthma adult-onse. some of them were selected to be implemented and recalibrated on the datasets available on pulse repository and adding new variables [ ] . pulse architecture is composed by main structures [ ] : pulseair, app server, air quality distributed sensor system, gisdb, webgis and personal db. -pulse app: is the personal app provided to the participants in charge of collecting sensors data and interacting with the users to propose interventions and gamification. pulsair is available both for ios and android and can be connected to fitbit, garmin and asus health tracker devices. -air quality distributed sensor system: the pulse air quality sensor's system is composed of multiple type of sensors and sensor's datasets: it combines mobile sensors and mobile network of sensors in order monitor the variable trends in emission within urban areas with an high resolution and to appropriately address the temporal and spatial scales where usually pollutants are spread. two types of sensors has been used across pilots that are the aq x of dunavnet ( +, deployed in all pilots) and purpleair pa-ii sensor. the who definition of health includes reference to wellbeing: health is "a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity" [ ] . wellbeing is a dynamic construct comprised of several dimensions. in a cohomprensive view of wellness can be defined main domain of wellness: the psycological health, the physical health and the subjective wellbeing. subjective wellbeing (swb) is often measured via validated psychometric scales, and individual and community surveys. subjective wellbeing is linked to health-related quality of life (hrqol) but is not synonymous with it. the factors identified as the most important for subjective wellbeing vary across space, time and cultural context (fig. ) . wellness entails contemporary also the simultaneous fulfillment of the three types of needs. personal needs (e.g., health, self-determination, meaning, spirituality, and opportunities for growth), are intimately tied to the satisfaction of collective needs such as adequate health care, environmental protection, welfare policies, and a measure of economic equality; for citizens require public resources to pursue private aspirations and maintain their health. wellness also concerns relational needs. two sets of needs are primordial in pursuing healthy relationships among individuals and groups: respect for diversity and collaboration and democratic participation. most approaches to community wellbeing (or its associated terms) follow a components approach: the majority of them have, at their core, an emphasis on individual wellbeing. pulse has focused on defining and developing a new concept of urban wellbeing tied to the broader concept of urban health resilience. this recognizes the connections between the physical characteristics of the urban environment (including assets and deficits) and human health (including both physical and psychological health). the pulse concept of urban wellbeing refers to the interaction between the positive and negative experiences within cities (whether objective or subjective), and the individual and community practices of mobility and placemaking. this novel interpretation of wellbeing focuses on the dynamic interplay between individual psychological characteristics and strengths, neighborhoods in which people live and work, and the capacity of individuals to respond to environmental and interpersonal stressors [ ] . within our population urban health model, the physical and social environments are understood as key drivers of wellbeing. this prioritizes an integrated, or relational, approach to urban places and health equity, including population differences in wellbeing. central to this relational approach is the idea that place mattersthat our health and wellbeing are shaped by the characteristics of the settings where we live and work, and these environments are in turn shaped by our healthrelated actions and behaviours. several recent studies have highlighted this important dynamic. using data from the english longitudinal study of aging, hamer and shankar [ ] found that individuals who hold more negative perceptions of their neighbourhood report less positive wellbeing, and experience a greater decline in wellbeing over time. of course, place itself can have a profound impact on our wellbeing. in pulse, we contextualize wellbeing within a model of urban resilience: urban resilience refers to the ability of an urban system -and all its constituent socio-ecological and socio-technical networks across temporal and spatial scalesto maintain or rapidly return to desired functions in the face of a disturbance, to adapt to change, and to quickly transform systems that limit current or future adaptive capacity. in this definition, urban resilience is dynamic and offers multiple pathways to resilience (e.g., persistence, transition, and transformation). it recognizes the importance of temporal scale, and advocates general adaptability rather than specific adaptedness. the urban system is conceptualized as complex and adaptive, and it is composed of socioecological and socio-technical networks that extend across multiple spatial scales. resilience is framed as an explicitly desirable state and, therefore, should be negotiated among those who enact it empirically. resilient urban neighborhoods can be broadly defined as those that have lower than expected premature mortality (measured via the urban health indicators). in pulse, we define urban wellbeing as an integral component of urban resilience. urban wellbeing, in this context, refers to the individual traits and capacities to prepare for, respond to, and recover from the personal and interpersonal challenges encountered in cities. these challenges could include experiences of bias and exclusion, on the one hand, and exposure to under-resourced or polluted environments, on the other. each of these challenges is associated with physiological and psychological stress at the individual and community level. stress is, of course, antithetical to wellbeing. translating this concepts into data constructs two main instruments are available into pulse architecture: the risk assessment models, previously described and the urban maps. the physical environment, socio-economic and cultural conditions, urban planning, available public or private services and leisure facilities are some of the factors that can have an effect on a person's health. hence, an interest in the study of geographical patterns of health-related phenomena has increased in recent years. within this context, maps have been demonstrated to be a useful tool for showing the spatial distribution of many types of data used in public health in a visual and concise manner [ , ] . for example, it permits the study of general geographical patterns in health data and identifying specific high-risk locations. an example of these maps in pulse are the personal exposure maps. personal exposure is a concept from the epidemiological science to quantify the amount of pollution that each individual is exposed to, as a consequence of the living environment, habits etc. personal exposure has been obtained matching the data from the dense network of low-cost sensors and the informations on habits coming from the pulsair app. following the sampling rate of the sensors the data has been calculated. figure shows a map for the personal exposure to pm with an hourly frequency. furthermore using the gps tracks from the pulsair app, fitbit and the personal exposure, an estimate of inhaled pollutant has been obtain in association to three classes of movement by the speed of body translation; standing, walking and running, considering the breaths per minute and the air volume per breath [ ] . personal exposure result has been also traced into exposure paths as in fig. : a time-lapse of min correspond to a dot movement line. the multivariate data driven approach of pulse gives an example of a new conception of health and wellness, not only focused on individual health status, but also on the relationship between individual and environment. such vision can be also directed toward the definition of "planetary health" provided by "the lancet contdown" [ ] . the data driven approach pursuited in pulse has surely given a great opportunity to implement such a vision, that maybe would not so immediatiate without possibility to integrate different sources of data. air quality in europe comparative analysis of standardized indicators for smart sustainable cities: what indicators and standards to use and when? empowering citizens through perceptual sensing of urban environmental and health data following a participative citizen science approach world health organization -un habitat: global report on urban health who: closing the gap in a generation: health equity through action on the social determinants of health why we need urban health equity indicators: integrating science, policy, and community associations between neighborhood perceptions and mental well-being among older adults overview of the health and retirement study and introduction to the special issue identification of persons at high risk for type diabetes mellitus: do we need the oral glucose tolerance test? two risk-scoring systems for predicting incident diabetes mellitus in u.s. adults aged to years hapt d: high accuracy of prediction of t d with a model combining basic and advanced data depending on availability applied spatial statistics for public health data atlas de mortalidad en áreas pequeñas de la capv dynamic spatio-temporal health impact assessments using geolocated population-based data: the pulse project the lancet countdown on health and climate change: from years of inaction to a global transformation for public health ), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons license and indicate if changes were made. the images or other third party material in this chapter are included in the chapter's creative commons license, unless indicated otherwise in a credit line to the material. if material is not included in the chapter's creative commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use acknowledgments. this research was funded by the european union's research and innovation program h and is documented in grant no . in particular, pulse was funded under the call h -eu- . . in the topic sci-pm- - -big data supporting public health policies.more information on: www.project-pulse.eu. key: cord- - x d fb authors: sorenson, corinna; japinga, mark; crook, hannah; mcclellan, mark title: building a better health care system post-covid- : steps for reducing low-value and wasteful care date: - - journal: nejm catal innov care deliv doi: . /cat. . sha: doc_id: cord_uid: x d fb the upheaval in the provision of routine health care caused by the covid- pandemic offers an unprecedented opportunity to reduce low-value care significantly with concurrent efforts from providers and health systems, payers, policymakers, employers, and patients. to the system we had before, and this is an ideal time to build something better. but the window is already closing. in-person care has rebounded -outpatient care visits in june were about % lower than the baseline level, compared to % lower in march. without continued momentum, organizations risk reverting to "business as usual," especially with so many health care providers under intense financial strain from lost fee-for-service revenues. one key focus area for reopening should be identifying and reducing low-value care: medical services that provide little to no clinical benefit or may cause harm to patients, such as antibiotic use for a likely uncomplicated viral infection or imaging for non-specific low-back pain. use of low-value care is pervasive, accounting for % to % of annual health spending. , we should be spending this money instead on providing high-value care that benefits patients; building stronger prevention, public health, and pandemic preparedness capabilities; and, addressing health disparities and the systemic inequalities that underly them. to date, low-value care has been stubbornly difficult to reduce, due to a complex range of barriers. however, the system-wide disruption and resource scarcity brought forth by covid- has provided maybe the strongest impetus yet for rethinking how best to prioritize what and how much care to provide, to and by whom, and in which settings. recent reopening guidance from the cdc and cms highlights the importance of prioritizing services that most benefit patient health and reduce exposure to both covid- and broader care complications. , the coming months offer a unique and critical window for providers and health systems, and the stakeholders who support and interact with them, to take short-and long-term steps to reduce waste and build a better system that prioritizes high-quality, high-value care. we discuss these steps in more detail below. as a first step, providers and health systems should prioritize the safety of patients and health care workers alike by triaging treatment for high-need patients, helping them avoid the emergency department (ed) whenever possible. more broadly, providers should work with all patients to develop immediate care plans, or "care blueprints." such plans should weigh the benefits and harms of different therapeutic pathways while incorporating covid- risk. emerging guidance from professional associations and clinical experts can serve as important resources for development. - these care protocols offer an immediate opportunity to spur provider and patient discussion on the harms of unnecessary care. as a first step, providers and health systems should prioritize the safety of patients and health care workers alike by triaging treatment for high-need patients, helping them avoid the emergency department whenever possible." " on a macro-level, guidance and broader reopening plans could also include "do not restart" lists. for example, a group of expert oncologists recently called for eliminating treatments with marginal benefit in their recommendations for modifying oncology care due to covid- . suggestions include discontinuing the use of certain drugs and having shared decision-making discussions for continuing intensive treatment for incurable cancers. other experts have identified overuse practices in hospital medicine that can lead to harm of both patients and health care workers. a range of resources are available to help providers and health systems develop these lists, including choosing wisely and the u.s. preventive services task force recommendations and the task force on low-value care's "top five" services to. - existing tools such as the milliman medinsight health waste calculator and the research consortium for health care value assessment's low value care visualizer can also be employed to measure and track known lowvalue care services. , there are also publicly available algorithms that can be used to analyze select low-value services in administrative data. , once care returns closer to a steady-state, these tools can help monitor use, track progress, and identify new low-value care targets. (table ) to support "do not restart" lists, providers and health systems can encourage guidelines for concordant care and make it easier for physicians and other health care professionals to avoid lowvalue services and identify higher value alternatives. organizations could integrate appropriate care guidelines into point-of-care decision supports, such as alerts embedded into electronic health records, which would give front-line providers rapid access to evidence-based protocols. they could also offer regular provider reports, ideally with peer comparisons, on use of low-value care with recommendations on how to improve. • developed by professional societies, lists over commonly used tests or procedures by clinical area whose necessity should be questioned and discussed • offers education materials to facilitate conversations between providers and patients on unnecessary care u.s. preventive services taskforce t • panel of medical experts that reviews the evidence for and effectiveness of clinical services • issues evidence-based recommendations on the use of preventive services, using a letter grade system based on the balance of benefits and harms • lists almost grade d "discourage use of service" recommendations task force on low-value care's "top-five" services t • based on harms, costs, prevalence, and opportunity for change • the five services include: diagnostic testing and imaging prior to low-risk surgery; vitamin d screening; prostate specific antigen (psa) screening in men ages and older; imaging in the first six weeks of low back pain; and use of branded drugs when generics are available milliman medinsight health waste calculator t • proprietary tool available to health care organizations to identify and quantify unnecessary services using their own claims, billing, or electronic medical record data low value care visualizer t • free, open-source, web-based tool that helps organizations identify low-value care via their processed claims data and creates user-friendly visualizations of data publicly-available algorithms t , t • code sets or specifications to measure a range of low-value care services in medicare, medicaid, and commercial claims data leveraging alternative care pathways and care sites, such as telehealth, home-based care, and community-based care, can also help keep patients out of the ed and provide alternatives to lowvalue and wasteful care. ed visits and hospitalizations are frequently preventable and, once there, patients often receive unnecessary imaging and lab tests. instead of unnecessary imaging or surgery for back or joint pain, patients could receive home-based or telehealth physical therapy, which can be as effective as in-person therapy in certain cases. the covid- era also offers opportunities to advance other alternative care pathways, such as palliative care and onco-primary care survivorship clinics. , instead of cancer survivors seeing their oncologist in the hospital for a routine check-up, they could receive needed care by a pcp in a survivorship clinic. not only can these delivery alternatives result in safer and more efficient and effective care, they are likely to align more closely with patient preferences. , leveraging alternative care pathways and care sites, such as telehealth, home-based care, and community-based care, can also help keep patients out of the ed and provide alternatives to lowvalue and wasteful care." as providers and health care systems reintroduce care and implement new protocols, they should concurrently track and evaluate the impact on health outcomes, quality of care, patient experience, known or new disparities, and costs. the drastic changes in health care delivery due to covid- , combined with incremental resumption of elective procedures and services, provides a natural experiment to generate much needed evidence for eliminating or reducing many types of low-value care. such evidence could pinpoint situations where care is unnecessary or inappropriate in certain populations, settings, or circumstances, which would provide valuable insights on opportunities for broader care redesign. (table ) action from stakeholders across the health care system can help providers and health systems to reduce low-value care. payers play a critical role in adjusting incentives for providers so that providing high-value care and eliminating wasteful services are the right financial decision. payers could decrease or cease payment for low-value services that create excess risk in the pandemic and align coverage policies to support "do not restart" recommendations from professional organizations and practices. they could also support the development of alternative strategies via short-term payments to offset the costs of practice redesign and any necessary retraining, and ensure accessibility of actionable data and supportive tools for determining whether or not a procedure is necessary and tracking outcomes. if these efforts succeed, payers should promise to share savings with provider groups. some payers such as blue cross blue shield of massachusetts have already succeeded in reducing commonly overused services using these approaches. long-term, payers should accelerate development of value-based payment models. providers practicing within these models have been more successful in responding to the pandemic and weathering the ongoing economic uncertainties, as a result of more predictable financial structures and associated investments in infrastructure, staff, programs, and data systems to improve population health and care delivery. these are many of the same capabilities required to eliminate low-value services. payers should also engage consumers through this process, adopting value-based insurance design principles that deter use of low-value care and reduce barriers to necessary care. for example, if seeing a physical therapist via telehealth over an orthopedist in an office offers a safer, higher-value pathway, then benefit design should reflect this higher value through lower co-payments. many payers have provided expanded telehealth services with low or no copays during the pandemic. payers should also prioritize lower copays for high-value pandemic services like covid- testing and non-covid- essential care such as preventive and mental health services, while increasing cost-sharing for low-value, high-risk services like spinal fusion, knee arthroscopy, and other outpatient lab and surgical services. recent evidence indicates that utilization of low-value services can be reduced through modifying cost-sharing for patients. policymakers should create opportunities for providers, health systems, and payers to pilot innovative models that reduce low-value care and reflect the new covid- reality, integrating telehealth and a wider range of health care professionals. cms could direct additional covid- relief funding to hospitals and providers who agree to pilot new models for health care reopening that actively seek to aid in the pandemic response, and who participate in alternative payment models to build a stronger health care system. more broadly, cms should work with health care providers and payers to assess how and where relaxed telehealth regulations have worked particularly well to align care with patient need, using it as the basis for deciding how to continue to encourage effective telehealth. finally, cms should continue encouraging states to address social drivers of health and advance clinical and social care integration through waivers, such as north carolina's healthy opportunities pilots, as well as other policies that support home and community-based services. even though high unemployment due to covid- has underscored the weaknesses of employersponsored health care, the majority of americans are still insured in this manner-and the higher reimbursements health systems get from these plans means employers must also play a key role in building this new normal. they can accelerate the adoption of tools already used successfully by many large, self-insured employers to limit wasteful care. "centers of excellence" (coe) programs, in which employees pay reduced (or no) out-of-pocket costs in return for using a highquality institution, have reduced inappropriate joint and spine surgery for walmart enrollees by - % and reduced readmission rates by - %. , coes could also provide remote second opinions on treatment. high-value provider networks linked to employer benefit design are also encouraging enrollees to see providers that perform well on quality metrics, while encouraging lower performers to improve. these approaches should be applied systematically to a range of therapeutic areas, starting with those that have opportunities for reducing known unnecessary care, such as orthopedics, oncology, cardiology, and obstetrics. finally, patients seeking care as health systems reopen will have a critical impact on the development of the new normal. telehealth can make patient-provider interactions significantly easier and safer-a better medicare alliance poll found that % of seniors in medicare advantage using telehealth services had a "very or somewhat favorable experience." however, patients need help and support in distinguishing needed services worth the risk from those that are unnecessary, and providers must account for how health disparities and access issues can impact a patient's experience. shared decision-making strategies can help facilitate these discussions around the risks and benefits of in-person care and have been found to result in patients choosing less-invasive treatments. , patient engagement will be critical to building and maintaining trust in new care approaches and for monitoring health outcomes. while covid- has exposed critical gaps in the u.s. health care system, it has also created significant new opportunities, offering reason to hope for a better future. many of the capabilities required to respond effectively to covid- -proactive care management within the community, collaborative care coordination, nimble clinical practice and policy approaches, value-based payment and care delivery models, timely data collection and sharing, and a sense of shared responsibility to protect and improve population health -are similar to those needed to tackle lowvalue care and more broadly create a better system for delivering care. the range of actions we outline herein are certainly not exhaustive, but represent critical steps that a range of stakeholders can take in the coming months. now more than ever, we need to allocate our limited health care resources towards services that produce better outcomes, at lower costs, and that align with patient values and preferences. this "new normal" can help build a more flexible, innovative system for achieving these goals. how have healthcare utilization and spending changed so far during the coronavirus pandemic? peterson-kff the impact of the covid- pandemic on outpatient visits: practices are adapting to the new normal. the commonwealth fund eliminating waste in us health care waste in the us health care system: estimated costs and potential for savings low-value care: an intractable global problem with no quick fix re-opening facilities to provide non-emergent non-covid- healthcare: phase i. centers for medicare & medicaid services framework for healthcare systems providing non-covid- clinical care during the covid- pandemic navigating the covid- pandemic ethics and resource scarcity: asco recommendations for the oncology community during the covid- pandemic roadmap from aha, others for safely resuming elective surgery as covid- curve flattens. american hospital association modifying practices in gi oncology in the face of covid- : recommendations from expert oncologists on minimizing patient risk choosing wisely in the covid- era: preventing harm to healthcare workers choosing wisely. clinician lists. accessed preventive services task force grade d recommendations the top five low-value services. vbid health research consortium for health care value assessment replication code/data for medicare low-value care measurement. harvard dataverse choosing wisely claims-based technical specifications assessing the effectiveness of peer comparisons as a way to improve health care quality effects of virtual exercise rehabilitation in-home therapy compared with traditional care after total knee arthroplasty: veritas, a randomized controlled trial escaping the cancer care black hole. duke cancer institute stanford primary care doctor establishes clinic for cancer survivors systematic review of patient and caregivers' satisfaction with telehealth videoconferencing as a mode of service delivery in managing patients' health assessing patient preferences for the delivery of different community-based models of care using a discrete choice experiment changes in health care spending and quality years into global payment value-based care in the covid- era: enabling health care response and resilience. duke margolis center for health policy maintaining progress toward accountable care and payment reform during a pandemic, part : utilization and financial impact american's health insurance plans (ahip) the effect of increased cost-sharing on lowvalue service use supporting health care providers during and after the pandemic. a covid- health care resilience program. duke margolis center for health policy announcement: healthy opportunities pilots suspension. ncdhss staying mad: walmart gets even-by contracting directly walmart offers its workers free surgery (with a catch) seniors' experiences with medicare advantage amidst covid- . morning consult-better medicine alliance prospective study of surgical decision-making processes for contralateral prophylactic mastectomy in women with breast cancer patient-centered care is associated with decreased health care utilization key: cord- -yirpxgqi authors: ibáñez-vizoso, jesús e.; alberdi-páramo, Íñigo; díaz-marsá, marina title: international mental health perspectives on the novel coronavirus sars-cov- pandemic() date: - - journal: nan doi: . /j.rpsmen. . . sha: doc_id: cord_uid: yirpxgqi nan dear editor: different epidemics have taken place so far in the st century, caused by infectious diseases such as sars (severe acute respiratory syndrome) or mers (respiratory syndrome from the middle east). several studies have described an important psychological impact of these epidemics on the general population, patients, and health workers, proposing different measures to guarantee mental health and prevent the progression of psychopathology in these circumstances. , the emergence and rapid spread in wuhan, china, of the novel sars-cov- coronavirus led to unprecedented measures such as the lockdown of wuhan and millions of people in additional cities and provinces. the enormous psychosocial impact of these actions, together with the background described, fueled the rapid emergence in china of various psychological assistance services based on crisis intervention procedures. subsequently, different approaches in mental health have been promoted in countries such as south korea, japan and spain as the virus has spread internationally. , in late , the first cases of pneumonia of unknown cause were reported in wuhan. the sars-cov- coronavirus was soon identified as the causative agent of the covid- disease. it usually presents with fever, cough and dyspnea, presenting a mortality rate of approximately %. , on january , the who declared covid- as an epidemic and pheic (public health emergency of international concern). on march it was classified as a pandemic after its rapid international spread. the mental health effects of the new epidemic are mostly unknown. during the sars epidemic, the affected patients in a toronto hospital experienced fear, loneliness, anger, the psychological effects resulting from symptoms of infection and concern about quarantine and contagion. the fear of contagion stood out in the health workers. stigmatization affected both patients and professionals. among emergency staff in taiwan, . % had significant symptoms of post-traumatic stress syndrome. in the south korean mers epidemic, it was found that anxiety and anger symptoms predominated among isolated patients, especially in patients with a psychiatric history. these epidemics, caused by other coronaviruses, may offer clues about the possible effects on mental health of covid- in the general population, among patients and among health workers. among the general population, in a study carried out in china, more than half of the respondents reported a moderate---severe psychological impact, while . % and . % respectively reported moderate to severe depressive and anxious symptoms. it has been noted that among subjects suffering from mental illness, the impact could be even greater. , regarding patients diagnosed with covid- , it has been suggested that they may experience fear and distress from the potentially fatal consequences of infection and isolation. furthermore, the symptoms of infection and the adverse effects of treatment, such as insomnia caused by corticosteroids, could worsen anxiety and psychological distress. health workers face challenges such as healthcare overflow, the risk of infection, exposure to family grief, and ethical and moral dilemmas. , a study in china found among them a high prevalence of symptoms of depression, anxiety and insomnia ( . %, . % and . %, respectively). women, nurses, and the most exposed workers reported more symptoms. taken together, these data raise concern about the psychological well-being of the health personnel involved. the covid- pandemic has also required the quarantine of multiple subjects exposed to the infection, with uncertain effects on their mental health. in a recent review on the effect of quarantine of some epidemics of this century (sars, mers, a/h n flu and ebola), a higher prevalence of psychological distress, affective symptoms (low mood or irritability) and post-traumatic stress are described, some of which could be long-lasting. fear of contagion, lack of information, financial losses and stigma are some of the stressors associated with the quarantine, so measures are proposed aimed at improving communication or providing the necessary material means. some general principles have been established for the intervention with patients and health workers such as: (a) psychological support by multidisciplinary teams, with clinical screening for anxiety, depression and suicidality; https://doi.org/ . /j.rpsm. . . - /© sep y sepb. published by elsevier españa, s.l.u. all rights reserved. j o u r n a l p r e -p r o o f letter to the editor patients with psychiatric comorbidity should benefit from adequate follow-up; (b) accurate information to patients and health personnel; stay up to date and correct misinformation; (c) attention to symptoms such as insomnia as an early clinical marker; (d) efforts to overcome interpersonal isolation; (e) anticipate and counsel about stress reactions, teaching to recognize signs of distress and discussing strategies to reduce it. the responses of the majority of patients and health workers are adaptive to stress of this nature. , , furthermore, specific measures have been implemented in different places. in china, a national guideline of psychological crisis intervention was published for covid- . in wuhan, the most affected location, psychological intervention teams were organized, consisting of experts in psychological interventions, psychiatrists and psychological assistance hotline teams. this approach is proving effective and has been implemented in other hospitals. a free-access manual for psychological intervention and self-help was published in sichuan province, with detailed recommendations for different population groups (suspected patients, family members, doctors, etc.). -hour psychological assistance hotlines were also set up there, and an online survey on the mental health status of patients and medical workers was organized to collect information and offer recommendations based on the score. structured letter therapy has also been proposed in china for quarantined patients. in south korea, the national center for disaster trauma has distributed leaflets reporting alarm symptoms (somatic symptoms, insomnia, anxiety, poor concentration, etc.) that require evaluation by mental health professionals, and offer indications (contact with close friends, focus on reliable information, maintaining pleasant activities) for quarantined individuals. in japan, recent imperceptible-agent emergencies have increased fear associated with unseen agents such as infectious agents, and the spread of distress reactions or risky behaviors such as alcohol consumption is feared. it has been proposed to focus efforts on vulnerable populations: patients and their families, those of chinese origin, vulnerable populations due to their psychiatric background and health workers. as for spain, the rapid transmission of sars-cov- has prompted rapid setup by the psychiatry services of units for the psychological care of patients and health professionals, both face to face and by telephone. the spanish psychiatric society (sep) has released fact sheets for the general population describing common reactions to infectious epidemics, as well as tips for dealing with isolation and quarantine. likewise, it has issued recommendations to guarantee the mental health of health workers. regarding outpatient care for psychiatric patients, telemedicine encounters have been extended, for which there are apa (best practices in videoconferencing-based telemental health) guidelines updated in march . definitely, given the high psychosocial impact of the sars-cov- coronavirus pandemic, it is necessary to continue with the implementation and development of mental health services in the health response to covid- . the description of internationally adopted strategies can guide their 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american psychiatric association and the american telemedicine association. best practices in videoconferencingbased telemental health páramo a,b , marina díaz-marsá a,b,c a instituto de psiquiatría y salud mental key: cord- - ybyt r authors: hastings, gerard title: covid- : our last teachable moment date: - - journal: nan doi: . /emeraldopenres. . sha: doc_id: cord_uid: ybyt r covid- is bringing hardship and tragedy. health workers are having to take appalling risks; loved ones are being lost; lockdown is causing great distress. and, as always in testing times, the disadvantaged are being hit worst. as we emerge from the shadows, the call from the vested interests, from the systems current winners, will be for a rapid return to business as usual. we must resist this; business as usual got us into this mess. covid- is trying to tell us something; we health educators and social marketers must listen, think and, above all, take action. added in: ) a few points thanks to reviewers commentsimportant but not major ) new references (as endnotes) ) an acknowledgement to the referees. any further responses from the reviewers can be found at the end of the article revised heeding the call covid- is not the first warning we have had, but it is the first one we have had to heed. there have been other epidemics (bse, sars, mers, ebola) and other financial crises ( , , , , ) , but none has challenged us like covid. never before have we closed down our economy; stopped making, distributing, buying and consuming on a global scale. governments have been transformed, as if by magic, from reluctant nannies into muscular interventionists. overnight, cheap flights, pints in the pub and drives in the country have vanished; friends and family have gone off-limits. no previous calamity has so obviously touched everyone, from the amazonian villager to the captain of industry; from the head of state to the rough sleeper: we are all threatened by the virus; we all have to self-protect; we all have to accept our individual and collective responsibilities. those who don't, whatever their background, are castigated; lear jets and fat bank accounts might give you access to better outcomes , but the rich still have to obey the lockdown rules just like the rest of us . it is a rare moment of global unity and a valuable reminder of how much we have in common, how closely we depend on each other, how important our environment is to us. as a result, we have a unique opportunity to rediscover our humanity, to question our assumptions and to learn. unique not just because we have squandered previous warnings, but also because future ones are likely to be too extreme to provide any teachable moments. covid- has got our attention. it is telling us something about the state of our health systems, which have struggled to respond. it is telling us something about how we deal with epidemics, the roll of testing and herd immunity. it is telling us something about values: that caring is precious; that life is precarious; that human beings do, after all, matter more than money. but most of all it is telling us something about the flaws in our economic system. we already know about these, of coursesweatshops, conflict minerals, congenital inequality, plastic waste are all familiar scandals -but they have somehow remained remote. even climate breakdown, and the intergovernmental panel on climate change (ipcc)'s dire warnings have resulted in little more than foot-dragging and excuses. certainly, they have not caused us to act: more than half the c in the atmosphere has been put there since the ipcc's first report was published in . having got our attention, covid- has also delivered up a remarkable experiment: what happens when neoliberal capitalism is put on hold? when the factories close, the supply chains fracture, the shopping stops? a study which would never have been deemed ethical or feasible heretofore has gone ahead almost unnoticed, and the data is now in. the two-month economic shut-down in china improved air quality to such an extent that , lives were saved, including those of , underfives . this is twenty times more than were taken by the virus. far from the cure being worse than the disease, it turns out to be far better than business as usual; switching off capitalism not only protects us from the virus, it protects us from ourselves. predictably perhaps, usa today downplays the significance of the data: "at the most" it argues "it shows it's easy to overlook chronic, long-term health threats such as air pollution, and thus, harder to muster an adequate response" . le monde however, sees prima face evidence of systemic problems with neoliberal global capitalism , as does the french president whose march address to the nation proclaimed the need to cross-examine our economic system which has been shown by covid- to be so conspicuously flawed . the fact that the virus might also have negative environmental impacts, such as increasing our consumption of single-use plastics, only reinforces the need for a rethink . the figures from china also bring a message of hope: when we stop behaving badly, things can get better fast. the air improved and lives were saved as soon as the factories stopped. in italy the venetian canals turned back from black to blue just days after the shut-down began; in paris birdsong became audible for the first time in generations as soon as the traffic cleared. this chimes with longer term evidence showing that the oceans can recover when adequately protected, that whale populations grow with the control of commercial hunting. living in an era called the anthropocene brings with it an onerous burden of responsibility for planetary harm, but it also reminds us that change is possible: what we have despoiled we can reinstate. the covid warning is timely: we can still do something. at this point readers of health education might be asking what has this got to do with me? shouldn't we be talking about smoking, drinking and junk food? about how to get people to take up sound, evidence-based health advice? about social distancing and handwashing? not capitalism and the meaning of life. but these traditional public health concerns link directly to our current plight. one of the most significant advances is public health thinking over the last forty years has been the recognition and calling out of industrial epidemics and the commercial determinants of ill-health. the realisation that, whilst smoking, drinking and junk food are individual health behaviours, they are also big businesses -very big. in a world dominated by neoliberal capitalism this makes them remarkably powerful; corporations have become some of the largest and most formidable organisations on earth. they now dwarf countries: "the annual revenue of each of the five largest global corporations exceeds $ billion, more than the gdp of percent of the world's nations" , but have no democratic controls, few checks and balances and only one duty: to deliver ever greater returns to shareholders. their abundant wealth enables them to buy the best marketing and lobbying expertise. the history of tobacco control shows how powerful these tools are: the public health case can only be won when they are countermanded. in the uk, for example, where the last twenty years have seen the systematic removal of nearly all tobacco marketing, teen smoking has dropped to less than %. but in many countries tobacco marketing and smoking continue apace, and across the world marketing for everything else is expanding and, with digital, becoming ever more powerful. shoshana zuboff's forensic analysis shows how surveillance capitalism has given the marketer nuclear capability. by tracking our every keystroke, supplementing this with other sources of personal information and harnessing the resulting 'big data' to artificial intelligence they can determine what we know, feel and do even before we do -and manipulate us with the confidence of a puppeteer. marketing is no longer a hit and miss mix of judgement and artistry, it is a matter of "guaranteed outcomes" and "scientific certainty". covid has served to underline this power, as mark grindle points out: " the uk government's first response to coronavirus was to allow big us tech companies to centralise and mine confidential uk patients' health data" and "the scientific group for emergencies (sage) advising the uk government's response to the pandemic included those with evidenced and significant ai and data mining business interests." naomi klein confirms that this power grab is very much an international phenomenon . this dominance is coupled with inherent irresponsibility, as we in public health again know all too well. the tobacco, alcohol and food industries have long ignored, denied and down-played the health consequences of consuming their products in the relentless pursuit of profit; writing them off, with divine disregard, as 'externalities'. what is true for health consequences is also true for all the other untoward effects of neoliberal business. thomas piketty's work has shown that inequalities are not just an unfortunate side effect of the way we do business, they are the necessary result of it. when danny dorling argues the uk is now as unequal as it was in dickens' time, he is not pointing up an aberration, but exposing a systemic problem that is bound to get worse. it is the same with climate breakdown: it is inevitable that extractive business models predicated on perpetual growth, which treat pollution as one more externality and the planet as a dustbin, will cause ecological destruction. as morens and colleagues, writing in the new england journal of medicine, point out, covid- is just one more outcome of this "global, humandominated ecosystem that serves as a playground for the emergence and host-switching of animal viruses" . again, the virus is warning us: the epidemic is not an aberration but a symptom; not an act of god but an act of self-harm. for we health promoters and social marketers, it is the mother of all behaviour change challenges. we have to help people rethink and rework, not just the odd unhealthy habit, but our entire way of life. as with any complex change problem, this will involve both collective and individual action. now is the perfect time to move upstream. public health has never been in higher regard: appreciation of health workers and the need for greater investment in the health sector are at a premium. the benefits of prevention have been sanctified; a repeat performance is unthinkable. the inadequacy of market ideology, which undervalues the caring professions, treats hospitals like supermarkets and sees the public sector as a business opportunity, has been traduced as never before. furthermore, government has shown it can act. the mantras about free markets, consumer choice and perpetual growth that have been used to stymie public health progress since the industrial revolution have been decommissioned with the flick of a switch. presidents and prime ministers who have previously genuflected before the multinationals and bowed to their neoliberal needs have suddenly shown us who is boss. the world health organization (who) has demonstrated its supremacy over the world trade organization (wto): wealth may bring material benefits, but health is transcendent. this awakening needs to be knitted into our polity. at a global level, who must be accorded its place at the top table, its budget guaranteed not in the gift of populist politicians. decisions about trade, taxation, fiduciary mechanisms, fiscal policy all need to be made in the light of public health priorities. similarly, at a national level, health ministries need greater powers to guide policy, and at a local level, decisions about planning, housing, sanitation should all be steered by public health. but, just as the financiers and ceos have to eat humble pie, so do the rest of us. the problems of climate breakdown go deeper than financial mismanagement or selfish business practices; they stem from human arrogance. an egotistical sense that we come above and are in charge of nature, rather than a part of it. we have forgotten that we are just one species in millions, which, because of its over-sized brain, has been able to rise to world dominance in a very short space of time. our current parlous predicament demonstrates that our impressive processing power has not delivered up wisdom -at least to us in the wealthy north. as richard horton hesitantly acknowledges "perhaps we can't control the natural world after all. perhaps we are not quite as dominant as we once thought" . he is surely right, but somewhat late to the realisation; this is precisely what native americans and countless other indigenous peoples have tried to tell us for centuries even as we worked systematically to exterminate them. horton continues "if covid- eventually imbues human beings with some humility, it's possible that we will, after all, be receptive to the lessons of this lethal pandemic." i hope he is right again. whatever world polity emerges from this catastrophe it surely needs to put the natural world in its rightful and pivotal place. and this time it should be informed by indigenous peoples; as arundhati roy succinctly reminds us: "the people who created the crisis will not be the ones that come up with a solution" . vital though systemic change is, the individual cannot be let off the hook: in the final analysis, systems are made up of people. and neoliberal capitalism is, in one sense, remarkably benign. there is no physical compulsion to join the party: the stasi won't give you a am visit for not using amazon; there are no jackboots on the stairs if you omit to update your tesco clubcard; no one is hooded and beaten for not joining facebook. we do all these things voluntarily. indeed, we pay for the privilege, and in the process make a gift of our personal data so that our fealty can be marshalled even more effectively in the future. we don't just succumb, we collaborate. we don't even have the decency to be ashamed: we wear their logos, boast about our sweatshop bargains and inform on our friends and family with social media. the antidote is agency . the most important job of health educators and social marketers is to enable critical thinking; to raise awareness of our predicament; to reveal the chicanery of marketing (as has been done so effectively with tobacco); to remind people that, even in the maw of surveillance capitalism, they have a choice: they can refuse their consent. this may sound naïve, even unethical: how can i correct the failings of exxon mobil? against the might of zuckerberg my actions will always be puny; this is just victim blaming… there are three responses to this. the first is greta thunberg: small, disempowered individuals can make a difference. the second is philosophical, it concerns what it is to be human. the ability to make judgements, to think for ourselves, to retain a sense of control over our fate -however tenuous -are qualities that define us as people. without them we become subordinate to the decision making and priorities of others; we cease to exist. primo levi argued passionately that the nazi camps were designed to dehumanise their victims and so facilitate annihilation, and that the final privation was to take away any sense of agency. you had to hold on to this, he said, and you could do so -by refusing your consent. empowerment, taking responsibility, having a say in your own fate -these are not impositions, they are human rights. the third answer is practical: if not me, who? if not now, when? as theodor geisel says at the end of his ecological fable the lorax, "unless someone like you cares a whole awful lot, nothing is going to get better. it's not." we health educators and social marketers need to help people to care more; to think critically; to exercise their human rights. this is our job. and if dr seuss seems a bit whimsical, let us back him up with percy bysshe shelley's muscular reminder from the mask of anarchy: "we are many, they are few" . we not only have the wherewithal to bring about change, we have the power. nothing will happen without resistance; indeed, as the 'scream test' has it, if there is no push-back you are not doing it right. the current vested interests will resist change except that in their own interests. this is already happening. the car and fossil fuel interests have gained billions in subsidies along with reduced ecological regulation; single-use plastics are being boosted for their (completely unproven) covid prevention qualities; airlines are being bailed out. thus, corporate lobbying is gathering momentum as big business sees an opportunity to benefit from the crisis. we need to be promoting alternative ideas and policies, which put people and the planet, not profit, first. here are some initial suggestions: • bring the tech industry back into public ownership. the internet is an amazing and potentially liberating invention; the berners-lee vision of a system that can connect humankind and enable everyone to participate in building a progressive and egalitarian society is admirable, and just about, still alive. it will not happen in private hands: the internet provides the highways and byways of the modern era; it is the st century equivalent of the commons and needs to be rescued from enclosure. • sanitise commercial marketing. henceforth the need to be truthful shouldn't be a fanciful slogan , but a mandatory requirement. the french loi evin has demanded this of alcohol advertisers for a generation; the same discipline should be applied to all advertising. marketing should be there for one purpose only: to help consumers make better informed decisions -better for them and the planet; emotional appeals, celebrity endorsements, branding and others forms of maddison avenue manipulation only hinder this. • extend globalisation. in an interconnected world, solutions have to be global. our current problems are not caused by globalisation, just the inadequate and narrowly construed version of it focusing on economics and business which currently predominates. this needs to be broadened to take in much wider human and planetary needs; in particular, public health should be a key driver of decision making. • re-engineer the corporation to compel responsibility for all its actions. there shalt be no more externalities: every part of the business transaction has to be put on the balance sheet and opened to public scrutiny. the green new deal is a welcome move in this direction. • fundamentally reassess our geopolitical system. humankind needs to come together for a fundamental rethink, not in a davos style meeting of the usual corporate suspects, but a much wider gathering of people of all backgrounds -sociologists, ethicists, indigenous groups, environmentalists, poets, health promoters, artists -to discuss how we can share the planet harmoniously both with each other and the rest of the natural world. this will call for great courage and monumental effort: the forces of neoliberalism will use every weapon at their disposal to retain their advantage. but it is our job to join, to lead, the charge for change. and when things get tough, as they surely will, remember that when global capitalism faltered the air got sweeter, the canals got cleaner and the birds sang louder. we might note then that the uk government's first response to coronavirus was to allow big us tech companies to centralise and mine confidential uk patients' health data . and we may note that the scientific group for emergencies (sage) advising the uk government's response to the pandemic included those with evidenced and significant ai and data mining business interests. the one consistent priority of the uk government and its advisors since before lockdown has not been testing, tracing and isolating or the sufficient provision of ppe for vulnerable frontline nhs and care home workers. it has been to develop and release a 'tracing' smartphone app whose purpose is to monitor citizens' movements, contacts, behaviours and yes -health data relating to covid- -at a national level. it further centralises and conveniently packages valuable health data. yes, we all want to get back to work -and safely. but when the passport back to work for those already disadvantaged is to buy a smartphone, pay for the data contract, download the app and pay the ongoing data charges -with the psychological stress that inevitably entails -we have to ask, who really stands to profit? the desires of vested interests for 'business as usual' is then not something that return, as hastings will argues. even at a time of a national health emergency they've not been curtailed. it's going to be hard to resist not just the return to business as usual but a new world order. and as we witness the mixed messaging emanating from whitehall about ending the lockdown -and the anxiety that that is causing -it is unlikely to be the disadvantaged who will benefit from it. but if we do learn who covid- and business as usual most disadvantages, we can exercise our human agency to say no. injustice: why social inequality persists escaping pandora's box -another novel coronavirus reviewer expertise: digital health; digital platforms to address mental health in frontline staff during covid- i would like to express my thanks to the two reviewers whose comments helped a great deal in strengthening this paper. version may reviewer report https://doi.org/ . /emeraldopenres. .r © dietrich t. this is an open access peer review report distributed under the terms of the creative commons , which permits unrestricted use, distribution, and reproduction in any medium, provided the original attribution license work is properly cited. griffith business school, griffith university, brisbane, qld, australia is the topic of the opinion article discussed accurately in the context of the current literature? yes it is. a very enjoyable and though-provoking piece hopefully becomes a wake up call for many more decision makers as they are being pushed (by the economic force) to return to business as usual.are all factual statements correct and adequately supported by citations? yes.i suggest adding the oil crisis to the listings of major financial shocks.i suggest revising "fat bank accounts provide no privileges" as i argue they would, particularly so during a pandemic. perhaps a bit more critical discussions could be added to highlight this.another site to lives saved and environment protected angle could be provided when stating that " the two-month economic shut-down in china improved air quality to such an extent that , ". we have had a surge in single-use plastic lives were saved, including those of under-fives pollution which may arguably be causing more damage the improvement in air pollution? see for example: https://www.weforum.org/agenda/ / /plastic-pollution-waste-pandemic-covid -coronavirus-recycling-susta are arguments sufficiently supported by evidence from the published literature? yes, very adequate for this opinion piece.are the conclusions drawn balanced and justified on the basis of the presented arguments? yes. our entire way of life has to change and health educators and social marketers are playing an important part in that. as with any complex change problem, this will involve both collective and individual action and the author provides a clear roadmap (particularly for the individual change section) in last pages of this article. although more practical guidance around how systematic change can occur during and following covid could be provided here to help social marketers and health educators better understand their role to influence upstream policy (even by just linking to some strong practical applications of upstream work). i was wondering if the flow would improve if the individual change is discussed before the system change and then finish with the competitive analysis (and perhaps change competitive analysis to "roadmap to change") and merge the last "action" section into that roadmap section as well? university of highlands and islands, inverness, uk hastings' article points to an ironic upside to the coronavirus pandemic, which is that lockdown has thrown into relief the benefits that result when the march of neoliberal capitalism is put on hold: overall improved human and environmental health. it also suggests that the most disadvantaged are those who are being hardest hit by coronavirus. if we all realise our agency, hastings argues, we can resist his predicted clarion call from 'the system's current winners' for a rapid return to the same 'business as usual' that caused and reinforces socioeconomic inequalities in the first place.the article is well-argued. but timely as its argument may be, the global response to covid- is fast-developing. we might then update the article with new evidence. we now know that the most disadvantaged individuals in england and wales are % more likely to die from the virus than those who are better off.the article is well cited. hastings' citation of zuboff's 'surveillance capitalism' is entirely appropriate. data mining gives corporate marketers and governments scientific certainty with which to manipulate health and consumption behaviours. data is the new oil; and you don't acquire valuable resources without mining them. when that resource is data, mining means the monitoring and surveillance of large populations. office of national statistics reference source . lewis p, conn d, pegg d: uk government using confidential patient data in coronavirus response. the . . reference source . carrell s: no advisers at sage meetings: key questions that need answering.. . is the topic of the opinion article discussed accurately in the context of the current literature? yes key: cord- -tdrhcq z authors: mjåset, christer title: on having a national strategy in a time of crisis: covid- lessons from norway date: - - journal: nejm catal innov care deliv doi: . /cat. . sha: doc_id: cord_uid: tdrhcq z early action and a unified approach by a norwegian health care system that features universal care and a single public payer has contributed to successes in dealing with the novel coronavirus. there have been challenges, of course, and other factors cannot be overlooked, such as the nation’s relatively healthy population, which is small and well dispersed. this article outlines how norway has responded, and how others may benefit from that experience. the norwegian health services are a single-payer system with one taxation-based health insurance covering all citizens. specialized care is handled by four regional health trusts that own local hospitals and buy services from a few nonprofit or for-profit providers. primary care is run by the municipalities, which hire independent primary care physicians (pcps), and every citizen is placed on a patient list to a pcp of their own choice. about % of the population carries supplementary private health insurance through for-profit insurers; the coverage is mainly employer-based and enables quicker access to some elective services and greater choice of private providers but not acute care. because the single-payer plan covers every type of advanced treatment apart from adult dental care, it is debated whether this insurance is necessary. for every norwegian, there is a cap on the annual co-payments tied to medical treatment and subscription drugs, approximately $ (usd, based on the april , , exchange rate), no insurance premiums, and no surprise bills, meaning health care in norway is regarded as a right, not something you buy. the first norwegian covid- patient was diagnosed on february , . at that point, the health authorities had alerted municipalities to test patients coming from known disease-prevalent areas, such as wuhan in china; norway's patient zero was diagnosed after a routine medical check-up and immediately quarantined. many more would be diagnosed in the following days. the national winter break had just ended, and many norwegians had spent their holiday week in northern italy going skiing. however, the work at the norwegian directorate of health-a specialist governmental body in the area of public health, living conditions, and health services underlying the ministry of healthhad already begun. after getting the first message about what was then only the potential covid- threat from the world health organization on january , , the directorate of health had, by january , alerted municipalities and hospitals across the country, as well as the public, about a possible pandemic. finally, on january , , the directorate was given the authority by the ministry of health to coordinate the covid- work for all of the norwegian health services. the directorate of health had, by january , alerted municipalities and hospitals across the country, as well as the public, about a possible pandemic." an emergency unit of leading health care officials was formed, and a clear strategy was developed to flatten the curve of newly infected individuals to prevent overwhelming the health care services and to reduce mortality rates. , based on reports from the norwegian institute of public health, an early and important measure turned out to be the early and aggressive testing regime. it included testing of all people in confirmed contact with confirmed covid- cases, people who recently had been traveling in outbreak areas, such as italy and china, and screening of people with current airway infections. " the information gathered from the test data directly led to the decision on march , , to close schools and quarantine everyone entering the country for days, as it was becoming obvious that the virus was spreading freely in communities. , as of april , norway had tested . people per , population for covid- . by comparison, italy had tested . people per , population and the united states had tested just . people per , . , one of the success factors of the testing regime was the early involvement of all microbiological laboratories in the country. since january, these laboratories were repeatedly updated on recent developments of the virus outbreak and had therefore adopted the covid- rt-pcr test into their routine workflow by the beginning of february. after the first patients were diagnosed, temporary drive-through tents for testing patients were quickly put up outside hospitals, and a national effort was done by pcps to implement video consultations across the country (the rate of pcps offering video consultations went from % to almost % in a month) to segment care and to identify those who should be tested. , on march , , the national institute of public health announced that the national laboratory testing capacity was still high; at that time, norway had the seventh-highest infection rate in the world, after countries like china and iran, but no hospitalized patients and no deaths. as the number of infected people continued to rise in march, national treatment guidelines were sent out to hospitals on march . patients were advised to be treated at their local hospitals as long as there were available icu beds; also, all planned procedures were asked to be postponed, with exceptions for patient safety. as practically all norwegian physicians in specialized care are salaried, the work contract with the norwegian medical association representing physicians working in both public and nonprofit hospitals was renegotiated to give increased flexibility to providers during the pandemic. , also, the national guideline for prioritization of covid- patients developed in mid-march after a week-long hearing among providers and medical experts made it clear that the health authorities did not want an age limit for icu admission that was being practiced in italy at that time (no seriously ill covid- patients over age ), but rather individual evaluations based on existing condition-specific guidelines. another important measure was the early development of a strategy to ensure that all levels of the health care services had necessary critical equipment. in january, a regime was set up to make all the municipalities report their needs to the directorate of health, which then could prioritize where to send shipments of equipment while being in continuous discussion with local leaders. such items included personal protective equipment as well treatment, diagnostic, lab, life support, and durable medical equipment. the strength of the norwegian covid- response seems to be the early decision to pursue a national strategy, to coordinate efforts across regions as well as primary and specialized care, and the general willingness to listen to and trust the health authorities in a time of crisis." the hospitals were asked to report to their own regional health trust, and the south-eastern norway regional health authority was designated to create a national storage supply to serve all levels of covid-related care for all regions. after involving the ministry of foreign affairs and the state-owned company operating most of the civil norwegian airports, transport airplanes were chartered in mid-march to bring in equipment from abroad. as new shipments keep on entering the country by air or land, small samples of goods are routinely tested by the research laboratory of the norwegian armed forces to ensure that the quality of the face masks, goggles, gowns, etc. is sufficient. , not all of the measures mentioned in this paper have been celebrated by the norwegian public or medical community. the health authorities have been criticized for being too slow to impose quarantines, entry bans, and other restrictions for citizens, and for having lacked supplies of critical equipment necessary to meet a pandemic the size of the current one, which in mid-march for a short while led to testing restrictions. - still, the strength of the norwegian covid- response seems to be the early decision to pursue a national strategy, to coordinate efforts across regions as well as primary and specialized care, and the general willingness to listen to and trust the health authorities in a time of crisis. this trust has, by many, been pointed out to be deeply rooted in norwegian mentality, although it is also a feature that is easily facilitated by the nature of a single-payer system with universal health care. when the government sent out word that people returning from abroad should be tested, people showed up to do so knowing that it would mean little or no expense to them. this made it easy for the authorities to locate the infected early and to trace everyone who had been interacting for more than minutes with infected individuals. in summary, strong governmental involvement, universal health coverage, well-planned regional health care integration, and a persistent national strategy seem to be decisive factors when taking on an epidemic of the magnitude of the covid- outbreak. in this way, the norwegian response to the current pandemic could provide lessons for other systems, including u.s. health care services. høie: -vi har coronaepidemien under kontroll live: corona-viruset sprer seg i norge og verden [live: the corona virus is spreading in norway and the world english translations for display: døde = dead, innlagte = hospitalized, intensiv = icu a vision for a high performing and sustainable health care system. government the norwegian health care system. the commonwealth fund ganger så mange private helseforsikringer på ti år [the number of people with private health insurance have increased times in ten years norskhelsenett første tilfelle av koronasmitte i norge minst av de norske coronasmittede har vaert på reise i italia koronavirus -brev fra helsedirektoratet og referater [the coronavirus -letter from the directorate of health and papers delegert myndighet i forbindelse med koronavirus-utbruddet håndvask er det aller viktigste smitteverntiltaket vi har sykepleien det er logiske brister i nesten alle beslutninger vi tar. [director general of health bjørn guldvog: -not everything we do is perfect. there are logical flaws in almost every decision we make norge er snart på verdenstoppen i koronasmitte. men egentlig er det en god nyhet . folkehelseinstituttet. covid- -epidemien: risikovurdering og respons i norge regjeringen setter inn «de sterkeste tiltakene vi har hatt i fredstid slik var spillet om de mest dramatiske tiltakene i norge siden krigen total tests for covid- per , people. to understand the global pandemic, we need global testing -the our world in data covid- testing dataset. our world in data direktoratet for e-helse: -voldsom økning i videokonsultasjoner drar stor nytte av videokonsultasjoner under korona-pandemien avtaler om arbeidstid for sykehusene våre medlemmer driver norge helseminister høie vil ikke sette aldersgrense for behandling [minister of health høie will not set an age limit for treatment fredag landa den største leveransen av smittevernutstyr sidan starten på koronakrisa i noreg smittevernutstyr på vei ut til hele landet store forskjeller da helse-norge forberedte seg på koronautbrudd leger mener norge skulle ha handlet raskere ny hurtigtest for koronavirus utviklet nordmenn har høy tillit til helsevesenet under koronakrisen nordmenn på tillitstoppen i europa key: cord- - wkes nk authors: goggin, gerard title: covid- apps in singapore and australia: reimagining healthy nations with digital technology date: - - journal: nan doi: . / x sha: doc_id: cord_uid: wkes nk widely and intensively used digital technologies have been an important feature of international responses to the covid- pandemic. one especially interesting class of such technologies are dedicated contact and tracing apps collecting proximity data via the bluetooth technology. in this article, i consider the development, deployment and imagined uses of apps in two countries: singapore, a pioneer in the field, with its tracetogether app, and australia, a country that adapted singapore’s app, devising its own covidsafe, as key to its national public health strategy early in the crisis. what is especially interesting about these cases is the privacy concerns the apps raised, and how these are dealt with in each country, also the ways in which each nation reimagines its immediate social future and health approach via such an app. a striking feature of the covid- pandemic has been the use of and appeal to digital technologies -fusing together what these technologies might offer in terms of efficacious communication and public health responses to help individuals and communities cope and contain the pandemic, on the one hand, as well as extending resources for social practices, expression, making sense, persisting with and reconfiguring rituals, and conjuring with the profound affective dimensions wrought by illness, death, loss, fear and isolation, on the other. in the pandemic, digital technologies have been used across societies, in a way that harked back to earlier ideas from the s of social life being nigh wholly dependent on life in 'cyberspace', and 'virtual communities'. with widespread access to and ownership and use of internet, mobile phones, social media, data, artificial intelligence (ai) and associated technologies already deeply, if very unequally, distributed globally, especially in middle-and high-income countries, the inception of the pandemic saw extended reliance on digital technologies -where terms of digital inclusion allowed for it. in a number of countries, governments also took the opportunity to issue calls to the acceleration of digitalisation, especially across groups and demographics where digital inclusion and take-up had been low, due to infrastructure, literacy and education, information and affordability. one stand-out area in this regard was apps. apps have been around since the s and s; however, it was the 'smartphone moment' of the launch of the apple iphone in , and subsequent development of the apps for apple mobile operating system devices (ios) and launch of its apps store, that kicked off the process by which apps became an integral part of everyday life for billions of users (goggin, ; miller and matyivenko, ; morris and murray, ) . from until the present day, technology companies around the world have offered their own apps and apps store, first with the 'app store' wars of - featuring many of the handset vendors that were household names in the worlds of g and g mobiles such as nokia and blackberry. competition was much more suggestion in china, evidenced by the many chinese app stores that dominate its huge market, and are significant distribution points for many users and communities internationally -especially given digital technologies being at the centre china's external trade, finance and soft power 'going out' (keane and wu, ) . thus, apps are key to what has been recently called 'infrastructural imaginaries' (nielson and pedersen, ; see also anand et al., ; athique and baulch, ; mansell, ) . so it is no surprise that apps formed a key part of the infrastructures woven into the pandemic, but also a specific, highly visible and 'normalized' response (hoffman, ) , in the form of dedicated apps -especially for tracing people and their 'contacts'. apps were used for many significant purposes during the pandemic. existing popular apps such as whatsapp were used in some countries to send official government messages and distribute crucial public health information. the data sets generated by smartphones, computers, apps and people's use of them, such as that data collected by apple and google, were used by public health officials, researchers and journalists to map population or district-level activity and movement, leading to the very interesting charts, graphs and visualisations in news and current affairs reports and features seeking to map and analyse the spread of covid and its impact on social and economic activity. apps allied with machine learning and ai were also used by medical researchers and clinicians to assist in the diagnosis of covid, by asking millions of users to track and enter their symptoms, diary-like, to offer a way of pinpointing when someone might have become positive. among the many varieties of covid-dedicated apps were apps devoted to the purpose of tracking people and their potential contacts, in case they contracted the virus. so many countries developed apps for tracking and contact tracing, with so many prototypes in development and implemented, that mit launched a contact tracing app database (https://www.scl.org/ news/ -the-mit-contact-tracing-app-database), based on key questions from american civil liberties union (aclu) white paper (aclu, ), to provide an authoritative reference point for those seeking to find their way through the claims and counter-claims of effectiveness. apple and google joined forces to amend their policies and create a joint protocol to make it easier for countries to use such data for contact tracing via apps (michael and abbas, ) . a full treatment of covid contact tracing apps is outside the scope of this article (see, for instance, cattuto et al., ; hoffman, ; vinuesa et al., ) . instead i focus on two especially interesting cases that offer us early insights into the socio-technical dynamics at play in such apps and the pandemic itself. these are singapore's tracetogether app and australia's covidsafe app. asian countries were often referred to for their decisive and often authoritative responses to the pandemic. however, it was singapore that attracted considerable early notice for its pioneering role in developing a particular kind of covid contact tracing app -that captured the imagination of many other countries. singapore was a pioneer in the development of covid bluetooth app in the form of its tracetogether app. what was less publicised was that, shortly after launch of tracetogether, singapore changed tack. this modification of the app deployment and promotion, and place in the overall public health strategy, was less evident outside the city-state. instead, singapore's tracetogether app became a stand-out model for other countries, rather than the various other apps being implemented around the world such as those developed by the united states, south korea, china, india or israel (babones, ) . australia comes into the picture because it is australia who first and most systematically sought to build on the tracetogether model, including its privacy safeguards, with its own covidsafe app. in the capstone analysis of their series of timely interventions into the privacy debates on the introduction of australia's covidsafe, leading privacy scholars graham greenleaf and katherine kemp ( ) note, 'australia's experiment is further advanced than most [countries] that are attempting to build a system based on voluntary uptake, protected by legislation (abstract, para ). the australian government sought to deploy covidsafe as a centrepiece of its effort to re-open australian society after the national and state lockdowns occasioned by the 'first wave' of infections from march to may . where public concern regarding and discussion of privacy issues was clearly presented but publicly muted in singapore, in australia there was furious debate. to explore the emergence, dynamics and implications of these two covid apps, i will proceed as follows. first, i introduce and discuss singapore's tracetogether, its development and first phase of take-up and deployment. second, i turn to australia's covidsafe and consider its fast journey from incubation and policy idea to the touchstone to warrant the country's re-opening, a veritable 'national service' (as prime minister morrison couched it). third, i return to singapore, to discuss the rebooting of tracetogether, after nearly months of tepid take-up, as that country's leadership sought to reassure its population that conditions were safe to re-open social life. finally, i offer concluding remarks about covid apps, social and technological imaginaries and digital media, as the nation state returns (flew et al., ) , and seek to gauge and exert its brittle powers, in a still deeply interconnected world. to great fanfare, a dedicated contact tracing app was unfurled as a breakthrough in monitoring outbreaks of covid- at the population level. while many teams around the world produced similar versions, the singapore government rolled out the first such app -called 'tracetogether'. tracetogether is an open source app based on bluetooth, using the 'bluetrace' protocol devised by a singapore government team led by the govtech agency -who have a track record of developing new kinds of open government apps, such as the parking.sg app. in a interview, for instance, janil puthucheary ( ), minister-in-charge of govtech, discussed how the 'govtech guys, as a result of having to do the code for the service . . . are having to . . . hack policy'. puthucheary explained, 'you have to be able to codify the policy', however that 'some of our governmental processes and regulations result in extremely inelegant code' (puthucheary, : ′ ″, ′ ″) . tracetogether was made available for adoption elsewhere via github. it is a combination of centralised contact tracing and follow-up (undertaken by government health authorities) and 'decentralised contact logging'. the user downloads the app and activates bluetooth on her device. the app can then detect another device in its vicinity, exchanging proximity information. to do so, the app uses information generated by the bluetooth relative signal strength indicator (rssi) readings that occur between devices over time to estimate proximity and duration of an encounter between users (team tracetogether, c). if a person fell ill with covid- , they could grant the ministry of health access to gather their tracetogether bluetooth proximity data -to assist in contacting people who had close contact with the infected app user. for their part, the developers emphasised their view that tracetogether would 'complement contact tracing, and is not a substitute for professional judgement and human involvement in contact tracing' (team tracetogether, d) . interestingly, they also underscored that the 'hybrid model' of decentralised and centralised approach is what they feel 'works for singapore' and that they 'built it specifically for singapore' (team tracetogether, b) . released on march by the ministry of health and govtech (baharudin and wong, ) , tracetogether received over half a million downloads in its first hours. a month later, the singapore government claimed the app had achieved a % adoption rate -some . million users, of an overall estimated population of . million users (team tracetogether, a). upon launch in singapore, there was relatively little public discussion of the privacy implications of tracetogether in mainstream media and fora -although there was considerable disquiet, criticism and debate evident in blogs, social media and elsewhere. for the most part, this is due to the structure and dynamics of singaporean society, and its political arrangements, public policy traditions and strong systems of social control and clear support for or alternatively discouragement and sanctioning of different kinds of expression and voicessomething well established in the scholarly literature (chua, ; george, george, , lee, lee, , , especially via various studies published in media international australia (most recently, lee and lee, ) . in recent years, the singapore government, following the dampened level of votes received by governing people's action party (pap), that has ruled since the , in the election, and a more sceptical populace (barr, ; zhang, ) , it has sought to extend consultation and formal 'listening' mechanisms to provide additional opportunities for citizens' voices. furthermore, while there has been increased discussion of privacy with the rise of digital technologies and unprecedented expansion of data generation, collection and use, the legal and regulatory framework is relatively weak in relation to privacy rights taken-for-granted in many jurisdictions (chesterman, (chesterman, , , even in the wake of the european general data protection directive (gdpr). however, as we shall see, such debate did build over some months, as tracetogether evolved. what is also important to note is that the singaporean government clearly acknowledged the strength of attitudes and importance of privacy and data protection concerns, and sought to anticipate debates by building in some level of privacy protection. the vision of tracetogether is that proximity data gathering is 'done in a peer-to-peer, decentralised fashion, to preserve privacy', and that it relies upon a 'trusted public health authority, committed to driving adoption' (team tracetogether, c). the developers and government emphasised that the privacy safeguards in the tracetogether app are in effect an effort of the longstanding ideal of 'privacy-by-design' (hustinx, ) . the government emphasised that the information was stored on a user's phone for days, and then deleted -and user's phone numbers are not exchanged, no geolocation data, personal identification data are not exchanged, so, as minister puthucheary noted, 'the engineering has preserved the privacy of the users from each other'-calling the app 'fairly elegant', in the way it 'preserves a fair degree of privacy' (ng, ; see also govtech, ). almost immediately the app did receive notice and discussion internationally, as one of a growing number of examples of covid- contact tracings apps raising privacy concerns (hu, ) . meanwhile in singapore, tracetogether downloads flatlined. this occasioned international deliberation, such as an article in the wall street journal entitled 'singapore built a coronavirus app, but it hasn't worked so far' (lin and chong, ) . the stalled downloads of tracetogether brought into view the conversations about privacy concerns, and whether this was a factor in user's lack of motivation to download the app. another reason advanced was that the app posed challenges for battery draining, due to the need to keep phones on. this was a view put by the ceo of singapore's investment or sovereign wealth company temasek holdings, madame ho ching who has a reputation as a prolific commentator on public affairs by dint of her regular controversial facebook posts (ho is also the wife of prime minister lee hsien loong) in a facebook post of may on the problems with tracetogether (ho, a) . whether by design or dawning acceptance, the government eased back its public communication and encouragement for citizens and other residents alike to download and use tracetogether. instead, it encouraged businesses, organisations, government offices and other entities to use a range of techniques to gather information about people's movements -especially when they visited or spend significant time in public places. check-in was principally done via scanning of a national identity card or employment or work permit id card, or via an app called safeentry. based on scanning of qr codes specific to each location, the safeentry app, and the policy it supported, was comprehensively promoted by government. this contrasted with tracetogether, which was only lightly promoted by the singaporean government, with the major campaign at the outset of its launch. presumably, on a small island -city-state, with strong civil service corps, existing id systems (singpass), and tightly managed immigrant and foreign worker id and records, and digital government and technology capabilities, this evolving contact tracing system did not need to premised on an app such as tracetogether, which presumably government was happy to allow to 'fail fast', given the bugs it faced. despite the effectively prototypical status of tracetogether, one of the first jurisdictions to adopt the technology was australia. prime minister scott morrison referred to such an app as a key requirement in australia's ability make its transition out of lockdown (prime minister et al., ) . in a radio interview with national talk show host alan jones, morrison's language is instructive, because it imagines technology, especially automated technology, as taking the vagaries and morally dubious qualities of human agency out of the picture: '[w]e need to get an automatic industrial level tracing of the coronavirus . . . now, we've been working on this automatic process through an app that can ensure that we can know where the contacts were over that infection period and we can move very quickly to lock that down' (morrison, a: para ) . this kicked off a heated debate about privacy implications, leading a high-profile member of his own coalition government, rural parliamentarian barnaby joyce to declare that he would not be downloading the app -countered by many other public figures who promised to do so. despite the widespread criticism and concern, there was also significant support with some million downloads in the first day of its release, topping the million mark in early may (koslowski, ) , then . million by june (meixner, ) . these figures raise various concerns, such as whether those who download the app used or continued to use it. also what the rate of downloads were in different parts of the nation (slonim, ) . let alone whether the covidsafe app was playing a role in helping to trace contacts and find positive cases of the virus (preiss and dexter, ) . for the prime minister, the covidsafe app was a rhetorical centrepiece of his policy initiative to vouchsafe a loosening of restrictions and begin to repair the economic damage the virus caused: the chief medical officer's advice is we need the covidsafe app as part of the plan to save lives and save livelihoods. the more people who download this important public health app, the safer they and their family will be, the safer their community will be and the sooner we can safely lift restrictions and get back to business and do the things we love. (prime minister et al., : para ) while he drew attention to the voluntary, consent-based nature of the app, morrison also sought to exert maximal symbolic pressure by framing adoption in patriotic terms, likening it to national service in wartime (and also not ruling out making it mandatory) (gredley, ) : i'll be calling on australians to do it as a matter of national service. in the same way people used to buy war bonds, back in the war times, you know, to come together to support the effort . . . if you download this app you'll be helping save someone's life. (morrison, b: sec : ) on may , morrison announced that australia had earned an 'early mark', with restrictions being lifted in a week. in doing so, he spoke of the download numbers being a 'critical element' in deciding to what extent the easing would occur: 'mr morrison said not installing the app was like going into the "blazing sun" without wearing sunscreen' (armstrong and minear, ) . various commentators and researchers expressed their views on how to promote downloading and take-up of the app. in the australian financial review, a piece by technology editor paul smith, entitled 'think like a founder', reported, 'entrepreneurs and health technology experts have urged the government to adopt all the tricks of the start-up trade to get more australians downloading the covidsafe contact tracing app' (smith, ) . the australian chief scientist through his rapid research information forum commissioned a brief on motivators for use of the covidsafe app, supported by the australian academy of humanities, with professor genevieve bell as lead author, and various leading media, communications and humanities researchers among the contributing authors (bell et al., (disclosure: i was a peer reviewer of this brief)). the brief suggested that 'illustrating that covidsafe works as intended may assist decision-making for those yet to download the app' (bell et al., : ) . it also concluded that the stories we will tell about australian responses to, and uses of, covidsafe will matter too. the voices of trusted figures, community leaders, healthcare workers and citizens will likewise inform the adoption, and continued use of, covidsafe. (bell et al., : ) many of these 'stories' clustered about the public perceptions and debate about the privacy, data and surveillances implications of the covidsafe app (bell et al., ) , driven by long-standing sensitivities and attitudes of australians concerning privacy. stretching back to the infamous and ill-fated australia card proposal of , citizens' privacy concerns had been more recently exacerbated by the federal government's poor handling of the ramp-up of its national e-health records registration system, myhealth, which switched from an 'opt-in' to 'opt-out' basis in (komesaroff and kerridge, ; goggin et al., ) . with much at stake in terms of public health concerns at a critical juncture of the covid pandemic, the australian government emphasised that it was keen to adopt a 'consent-based' model, hence its interest in adapting the singapore tracetogether app. the government sought a formal privacy impact statement from a leading law firm -which it published, with a detailed response from the department of health ( b; maddocks, ) . this privacy impact documentation put important details of the workings of the covidsafe application, and the production, storage and handling, of resulting user data on the public record. in response, the government emphasised that participation would be voluntary (department of health, a); however the privacy impact statement noted the potential for third-parties such as workplaces or businesses put pressure on or require people to use the app (maddocks, ) . deleting the app would also delete the data stored on a user's device, but not data in the national data store (however, the government guaranteed that all data held would be deleted at the end of the pandemic). the government was at pains to reassure the public on the secure hosting of the covidsafe data store, undertaken by amazon web services (aws). their guarantees related to the data privacy and security obligations applying to aws, but also to any prospect that such data might be requested and commandeered by the us government (given aws is headquartered in the united states, and subject to their laws). over some weeks a furious debate ensued, and the australian government proposed legislation to address the key concerns. this safeguard took the form of the privacy amendment (public health contact information) act . the bill quickly passed through the house of representatives and the senate and received assent on may . the act creates several serious offences dealing with covid app data, including 'non-permitted, use, or disclosure', 'uploading covid app data without consent', 'retaining or disclosing uploaded data outside australia', 'decrypting encrypted covid app data' and 'requiring participation in relation to covidsafe' (privacy amendment, : ). 'covid app data' is defined as 'data relating to a person . . . collected or generated . . . through the operation of covidsafe' and is either 'registration data' or 'is stored, or has been stored . . . on a communication device' (s. d ( ) (a-b), privacy amendment, : - ). while the bill was passed containing significant safeguards, it contained serious flaws. as summarised by greenleaf and kemp, these included key information upon which the law was based and would operate was not made available to the public, including advices to the minister upon which he relied to make the earlier determination, and, crucially, the agreements between the commonwealth and states and territories regarding the operation of the covidsafe app, and collection and sharing of app data; lack of public assessment of the law by the federal and states and territories privacy commissioners; and only the source code for the covidsafe app was released, not the code for the national covidsafe data store (i.e. the server-side of the system, where security and privacy issues often manifest) (greenleaf and kemp, ) . in addition, greenleaf and kemp critique the narrow focus of the privacy act amendment on 'covid app data', suggesting instead that what is being created is an information system they dub the 'covidsafe system' (greenleaf and kemp, ) . as well as the specific defects of the new law, then, the major issue it raises is precisely the one feared by many experts and members of the public alike: that the app-based contact tracing represented by covidsafe, and other apps around the world, represent a deepening of technologies of surveillance in social life. while such apps and measures in which they are embedded are justified as exigent public health measures crucial in the emergency conditions of a pandemic, there is wellfounded fears that this increase in surveillance will not be automatically or easily rolled back once countries feel the threat of covid is ended or at least contained. as australian debates over covidsafe privacy subsided, there was a slow return to tracetogether emerging in singapore as the country's leadership gingerly considered how to effect its re-opening from its -month circuit breaker. a task all the more urgent, given the ruling party's dwindling time to call a national election. singapore's was regarded an international model of wise and swift response with its handling of its 'first wave' of infections. however, in the second week of march , singapore tightened its measures, enacting a general shutdown and stay-at-home policy that it dubbed a 'circuit breaker'. initially the circuit breaker was announced to last for month, but with the rising tide of positive cases in the crowded migrant worker dormitories, the government quickly extended for a second month. a disturbing feature of singapore's data gathering and public reporting and communication during this period was the distinction clearly drawn and maintained in the daily bulletins between; cases in the migrant worker dormitories; and 'community cases' (these community cases were in turn divided between figures on singapore citizens, permanent residents (prs), migrant workers on work permits and workers on employment passes) (han, ; palma, ) . the migrant workers were quarantined in the dormitories, with many then moved to across other repurposed facilities. and the numbers of cases were similarly quarantined, in a communicative-epistemological manner, to emphasise that the 'real' community spread remained low (usually below cases in the 'community'). those numbered among the community included citizens and prs initially, but subsequently, foreign pass holders who do not reside in dormitories but lived among the regular population, became part of these statistics once the dormitory cases started subsiding. ahead of the planned end to the circuit breaker on june, the government made some mention of tracetogether at various times in its public communications. however, its main focus remained racking movement and individuals' location via check-in at the public places and business still open, such as convenience stores and shopping centres, or in taxis and ride-hailing services, especially via the safeentry app discussed above. as the re-opening loomed, there was increasing discussion in government, and in parliament, on measures that would need to be implemented to contain and reduce the number of infections via contacts with migrant workers, especially once they were allowed to more regularly leave the dormitories, where they had been quarantined during the circuit-breaker period, and so circulate in the 'community'. the government announced a new app, sgworkpass, to 'show which migrant workers can leave their dormitories for work' . workers will 'get a "green status" on the app to indicate that their employer has been granted approval to resume operations, and that the dorm they stay in has been cleared' . otherwise, the app will show red to indicate they 'cannot go out for work' . this is reminiscent of the chinese app, also adopted by india, which uses qrs, to show a user's status as green (when they may enter offices, restaurants, malls or parks), or yellow (at risk) or red (strict quarantine) (hu, ; india today, ) . at this stage, tracetogether returned -this time, as a central feature of the strategy. the government had been at pains to keep tracetogether opt-in, with foreign minister vivian balakrishnan, also minister-in-charge of the smart nation initiative, providing reassurance that the app would remain voluntary 'as long as possible' (balakrishnan, ) . in early june, balakrishnan noted the problems with tracetogether, including the technical issues with the app not running properly on apple. as a result, he let it be known that singaporean government was developing a 'portable wearable device' that will achieve the same end, that if it worked could be 'distributed to everyone in singapore': 'i believe this will be more inclusive, and it will ensure that all of us will be protected' (balakrishnan, ) . the government emphasised that there would no 'gps chip' on the device, nor any internet connectivity. even then, the tracetogether token would need to be physically handed to the health ministry for uploading of the data, if a user tested positive for covid- (yu, ) . the government's keenness to be seen to address privacy was doubtless fuelled by a public backlash against the token. as policy researcher and commentator carol soon, from the institute of policy studies, noted, 'within a short span of three days, a petition against the development of the device attracted about , signatories' (soon, ) . concerns of singaporeans regarding data privacy were addressed in a report authored by her colleagues, which found attitudes vary according to the technology involved, illustrated by the finding that nearly in respondents supported use of cctv to monitor people's movements during the covid 'circuit breaker period', but less than % were comfortable with having their mobile phone data tracked for contact tracing without their consent (tay, ) . to address such deep-seated concerns, soon suggested the need for singapore to urgently 'achieve a working compromise between personal data and public good', establishing principles and considering measures such as formation of a citizen's panel for public deliberation (soon, ) . regardless, the first batch of , tracetogether tokens were distributed to seniors shortly on the eve of the july general election -with officials from the smart nation and digital government group (sndgg) suggesting they were settling in for a long haul, saying the government will 'continue to generate more awareness about the token among our prioritised population' (sndgg officials quoted in yip, ). at the time of writing, the pandemic rages globally, and the career of covid- contact tracing apps is still unfolding -with little evidence as yet of their efficacy. however, there are already clear grounds for concerns. the strange thing about the australian embrace of bluetooth-based covid tracing apps is how strongly it figured, for a time at least, as instrumental to the country's public health response. various commentators noted the irony that at the point covidsafe was being pushed upon the public, australia was at a positive inflection point in terms of infections. as greenleaf and kemp note, this set the bar because other measures had already appeared to be successful in greatly abridging the spread of the virus (greenleaf and kemp, : ) . the other obvious thing is that where apps did play a role in diminishing infection rates, these were not: ( ) bluetooth-based tracing apps, ( ) and the apps used were integrated into a wider system of cross-referencing and marshalling personal identification and contact information and database systems (greenleaf and kemp, ). yet the australian government, for a short time at least, was very keen on the app as a symbolic game-changer in its public health approach to the pandemic -showing that it was taking charge. rather like british health secretary, matt hancock some weeks later, when he promoted the english app-based test-and-trace system, telling the public 'it is your civic duty': do it for the people you love. do it for the community. do it for the nhs and do it for all the frontline workers . . . you'll have the knowledge that when the call came you did your bit, at a time when it really mattered. (hancock quoted in bosley and stewart, ) in july , there was an outbreak of covid- cases that saw a lockdown re-imposed, and fuelled national concerns. at the time victorian chief medical officer brett sutton said the 'app has not added a close contact' that authorities had not already discovered via traditional contact tracing (borys, ) . federal health minister greg hunt advised that at least contacts nationally had been identified via the covidsafe app (borys, ) . for her part, nsw's chief health officer kerry chant, the state next in line for a potential resurgence of cases described the app as 'one of the tools', but not a 'major feature' in contact tracing (borys, ) . in his parsing of the app's effectiveness, australian deputy chief medical officer, dr nick coatsworth, suggested that because of movement restriction, people had not been circulating, so the 'app hasn't identified those cases', and that as 'numbers go up then the app can come into its own' (coatsworth, ) . with the groundswell for mask use in mind, coatsworth ( ) cleverly sought to link the two, suggesting 'if you are a supporter of mask use, you must also be based on the modelling, a supporter of downloading and activating the app' (here he refers to the study by sax institute, see currie et al., ) . for its part, singapore took a less dramatic, more considered approach, especially in the first phase as it developed and launched its tracetogether app. singaporean leaders and health officials were also preoccupied with promoting the app to gain the maximum take-up and adherence. yet, for reasons not entirely clear as yet, singapore was reluctant to push the adoption of the app to the extent that australia did -an interesting situation given earlier critiques of singapore technocratic approach to health care, in particular (barr, ) . as well as the privacy concerns that emerged in the second phase of the tracetogether token initiative, it may be that singaporean actors thought the app was promising but not the main game. this would be because of the already well entrenched systems of requiring and using personal data, through an extensive infrastructure of technologies (including the cctvs that featured in the ips report), without the kind of concomitant privacy rights and practices that would be expected in some other jurisdictions such as australia. the task of enlisting and normalising singaporeans participation in these aspects of its surveillance-extensive 'smart nation' policies, over cumulative implementation of technology is taken to be essential, but it is increasingly fraught (lee, ) . in the first months of pandemic response, then, the central element was singapore's established singpass and other systems of identification cards and passes, which could be used in coordination with video recordings, and the wealth of digital data available from urban transportation systems, stored valued and transit cards, ride-hailing accounts and so on. as well as also as the citizen and netizen sousveillance and activism that saw recordings of potential miscreants breaching the regulations circulated online. in addition in the early weeks of the pandemic, identifying details of people's residential locations, down to building numbers, were published in daily updates from ministry of health, and reprinted in media outlets. such measures point to the differences in privacy laws and protections in singapore, as compared to australia. whereas australian privacy act dates back to , singapore only enacted its first comprehensive law in , the personal data protection act. at the time, legal scholar simon chesterman suggested that singaporean had taken a 'pragmatic approach', potentially striking a balance between european and us approaches: in singapore, at least, reform is not being driven by the desire to defend the rights of data subjects; rather, it is based primarily on economic considerations, as well as the desire to position singapore as a leader in the region for data storage and processing. (chesterman, : ) . the singapore laws and approach to privacy and data protection have not substantially changed since (chesterman, ; ong, ). yet clearly citizens do have concerns -as the public response to the tracetogether token suggest. from a broader perspective, the return of tracetogether to the fore of the singaporean government's strategy, especially to assist with the re-opening process after its 'circuit breaker', is very interesting indeed in the context of the country's digitally underpinned governmentality (ho, ; lee, lee, , willems and graham, ) . this is worth being in mind in interpreting the election, in which the government received some strong criticism by opposition candidates for its poor handling of the pandemic, especially concerning the continuing high number of cases in migrant worker dormitories. the pap was returned to government, still with a 'super majority', of seats out of the available . however, it was chastened by its share of the vote being reduced to . % (from its . % share in the election) -and an unprecedented seats won by the opposition workers' party (loh, ) . in the aftermath, the government has signalled its willingness on listening to electorate concerns, especially those of young voters (yong, ) . all in all, in both these case studies, we see that the variations of the covid- contact tracing apps, and the technical, social, policy and design dynamics of these, offer rich food for thought when it comes to understanding apps. health information is an area of considerable sensitivity for most people. trust is key, and with the widespread diffusion of mobile communication there has been considerable work on how to design and implement systems that can support cooperative and sustainable sharing of information between people and authorities to map the spread of infectious diseases (lwin et al., ) . however, it is now evident that the task of assembling appropriate social and cultural understandings of people's lives and identities, their data selves (lupton, ) , the intricacies of technologies, the enmeshing of privacy expectations in design, and the construction of suitable legal, policy and governance arrangements, is challenging. in the covid- pandemic, many countries across the world have had recourse to apps, as flexible agents with capacity to encode, materialise, represent and integrate such requirements, including some contradictory ones, and imagine and forge majoritarian supported social action. it is difficult not to see the turn to tracing apps as a pivotal moment in the expansion and entrenchment of surveillance technology in digital societies, of which singapore in particular has been a leading example (lee, ) -but is also playing out in contests and debates in many countries especially in europe and asia. how this ultimately turns out, and with what benefits for health, as well as legacies for democratic freedoms and daily life, we must wait and see. american civil liberties union 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surveillance method methods: ips study. strait times, may team tracetogether ( b) can you make tracetogether available to other countries? media release how does tracetogether measure distance and duration of contact? what thresholds constitute close contact? media release team tracetogether ( d) what is blue trace? media release available at a socio-technical framework for digital contact tracing the imagination of singapore's smart nation as digital infrastructure: rendering (digital work) invisible. east asian science yip wy ( ) coronavirus: , seniors get first batch of tracetogether tokens. straits times ge : signs of young voters' crucial role in election outcome singapore looks to ease privacy fears with 'no internet' wearable device. zd net social media and elections in singapore: comparing my thanks to two reviewers for helpful suggestions. thanks also to rosemary curtis for her proofing of this article. the author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article. the author(s) received no financial support for the research, authorship and/or publication of this article. https://orcid.org/ - - - key: cord- -ezwt rq authors: asayama, shinichiro; emori, seita; sugiyama, masahiro; kasuga, fumiko; watanabe, chiho title: are we ignoring a black elephant in the anthropocene? climate change and global pandemic as the crisis in health and equality date: - - journal: sustain sci doi: . /s - - - sha: doc_id: cord_uid: ezwt rq climate change and coronavirus pandemic are the twin crises in the anthropocene, the era in which unsustainable growth of human activities has led to a significant change in the global environment. the two crises have also exposed a chronic social illness of our time—a deep, widespread inequality in society. whilst the circumstances are unfortunate, the pandemic can provide an opportunity for sustainability scientists to focus more on human society and its inequalities, rather than a sole focus on the natural environment. it opens the way for a new normative commitment of science in a time of crises. we suggest three agendas for future climate and sustainability research after the pandemic: ( ) focus on health and well-being, ( ) moral engagement through empathy, and ( ) science of loss for managing grief. we cannot solve a crisis without treating it as a crisis.-greta thunberg in december , a young swedish girl, greta thunberg, made a public speech at the twenty-fourth conference of parties to the united nations framework convention on climate change in katowice, poland. after that, she soon became a global icon of new-generation climate activism. the above catchphrase alluded to the disjuncture between a growing sense of urgency of global climate risk and a sluggish pace of policy actions on reducing greenhouse gas emissions. it effectively captures the public's frustration at inadequate governmental responses to the climate crisis. but this now famous line of hers also raises an important question: what kind of crisis climate change is and what does "treating a crisis as a crisis" really mean? in many senses, the coronavirus disease pandemic testifies to what policy responses to a crisis look like. in times of crisis, decisive intervention is required to prevent catastrophic damage from unfolding (hulme et al. ; lidskog et al. ) . the mathematical models predicted that unmitigated virus outbreak would lead to a precipitous rise in death rates from covid- (adam ). the distressing model predictions forced many governments to swiftly impose emergency measures that were unimaginable in normal times, such as shutting down schools and business, prohibiting public gatherings and closing national borders. just like rescuing a patient taken to a hospital emergency room, these draconian measures were justified simply because it is ethically unacceptable not to save lives from preventable deaths (orr and wolff ) . zinn ( ) called covid- a "monstrous threat" that "legitimises significant restrictions to people's freedom and is justified by the ethics to keep everyone safe". however, the covid- pandemic has also revealed an underlying chronic social illness of the world: pervasive social and economic inequalities (zinn ) . a blanket implementation of population-wide preventive health interventions such as national lockdowns hit the already vulnerable groups of people hardest, thereby exacerbating the inequality in health (frohlich and potvin ; lancet ; newland ) . not only are they in a high risk of contracting the virus due to a lack of space for physical distancing but also they bear the secondary cost of deprived livelihood by lockdowns. the pandemic put vulnerable populations in double jeopardy. this inequality paradox involved with covid- response shows clearly the social nature of the crises we face (hulme et al. ) . insomuch as governments need to control the virus and hence maintain the healthcare system for patient treatment, they must also protect the economy to help those who are affected by secondary risks of the pandemic not to fall into impoverishment (mckee and stuckler ). at the centre of responding to the coronavirus crisis are health and equality (or lack thereof), both of which are inextricably tied to each other. in this essay, we argue that both climate change and global pandemic are the result of the unsustainable growth of human activities. the two crises are a true testament to the anthropocene, a new geological epoch of our own making (crutzen ) . the pandemic can provide an unfortunate yet rare opportunity to take more seriously the concept of health in environmental sustainability research. a focus on health and well-being in the sustainability challenges helps us to pay judicious attention to human society and inequalities within it rather than the natural environment. the fundamental ethical challenge is, however, to create a shared sense of responsibility for protecting the health of "unknown others" through empathy. when the novel coronavirus emerged first in wuhan, china, at the end of , causing severe respiratory diseases, it was a big surprise. in the eyes of many people, covid- appeared to be a sudden crisis came out from nowhere. however, disease ecologists have been warning, for a long time, of the growing risk of emerging infectious diseases-in particular, zoonotic viruses that spill over from non-human animals into humans (daszak et al. ; jones et al. ). anthropogenic land-use change (i.e. deforestation caused by agricultural land acquisition) has led to wildlife habitat loss, which has subsequently increased the risk of zoonoses spillover (allen et al. ; gibb et al. ) . so, in the eyes of disease ecologists, even though how exactly the virus jumped from animals to humans is yet unknown, the emergence of novel coronavirus (originating from bats) was a predictable, imminent threat. just like climate scientists have anticipated that climate change would become a grave threat to humanity. a new york times opinion columnist, thomas friedman, described the covid- pandemic as a "black elephant": a cross between a "black swan" (an unlikely, unexpected event with enormous ramifications) and the "elephant in the room" (a looming disaster that is visible to everyone, yet no one wants to address). this character of "black elephant" events resonates with what risk analysists called the risk of cassandra-a greek mythological figure who was given the gift of prophecy but her true prophecies would not be believed (renn and klink ) . climate change and biodiversity loss are examples of such highly probable, catastrophic risks that no one is willing to acknowledge because of a slow, prolonged effect of environmental degradation. despite a striking difference of temporality , climate change and global pandemic are the twin crises in the anthropocene. the common, underlying cause of both is a planetary-scale, anthropogenic change in the natural environment-the earth's atmosphere and terrestrial land, respectively. an exponential growth in scale and speed of human activities ("great acceleration") constitutes the two crises as truly global challenges of the anthropocene (steffen et al. ) . they are equally "black elephants" in that scientists have long been sounding the alarm about a calamity caused by human actions but the governments paid woefully insufficient attention, despite knowing that ignorance will lead to dire consequences. importantly, what makes covid- a pandemic is hyperglobalisation of human travel (zhu et al. ) . for example, if this coronavirus emerged in human society, say, in rural china of s, it may still cause serious disease outbreak locally but will not probably become a pandemic as it is today. it is our highly-mobile modern lifestyle-globalised travel and rapid urbanisation-that provides warp speed for the virus spreading around the world. ironically, as zinn ( ) said, covid- "developed into a major social threat not mainly due to its ability to kill but by challenging our way of living". asymptomatic or presymptomatic transmission (he et al. ) allows the virus to spread without detection-an epidemiologist called it the "invisible pandemic" (giesecke ) . this points to that disease eradication (i.e. global reduction of infection to zero cases) is awfully difficult and that without vaccines, the world will be under constant threat of virus resurgence (heywood and macintyre ) . the punctuated normalcy that was imposed as a temporary state of emergency is then morphed into a "new normal" under the pandemic. the pandemic's nature of global systemic risk (renn et al. ) suggests that even the countries that succeeded in controlling or eliminating the virus such as new zealand are not free from interference. to prevent future outbreaks, they need to maintain a strict border-control policy , which costs their economy immensely. as the director-general of the world health organization (who), tedros adhanom ghebreyesus, remarked at the press conference on covid- response, the reality of the pandemic is that "no one is safe until everyone is safe". the same is true for climate change. the groundswell of climate change and its policy response will swallow up everyone. in other words, this inescapability of global interconnectedness is our new ontology of being humans in the anthropocene (lövbrand et al. ) . while climate change and global pandemic can be equally understood as great challenges in the anthropocene, their manifestation has been pronounced differently due to a difference in disciplinary concerns between environmental sustainability research and public health research. in the field of global environmental change research, climate change is often used as a shorthand for global sustainability challenges. the major concern of researchers in this field is largely concentrated upon regulating the stability of the earth system within "planetary boundaries"-a safe operating space for humanity (rockström et al. ; see also steffen et al. ) . the concept of planetary boundaries has become a dominant framework for integrating the physical science of understanding the processes of the earth system into the social science of studying the policy and governance response at the global level. it also provides a powerful narrative that captures the growing worries among scientists (and the public at large) over the alarming rate of environmental change which might be reaching beyond the earth's capacity to absorb human impacts and sustain life within it. some such scientists now characterise the °c of warming of global temperature as a planetary threshold that, if crossed, will push the earth system onto an irreversible pathway towards "hothouse earth" (steffen et al. ) . a call for declaring a climate emergency (lenton et al. ) is, in this respect, a political attempt by scientists to warn about how little time is left to avoid such a catastrophic scenario. a problem is however that there is little attention paid to the human societies, which are seen as an integral part of the earth system (steffen et al. ) . like a well-known german sociologist ulrich beck ( ) said: "if 'the environment' only includes everything which is not human, not social, then the concept is sociologically empty." richard horton, the editor-in-chief of the lancet, the prestigious medical journal, noticed this problem with a technical approach to the anthropocene challenge: the planetary boundaries approach is powerful. but it repeats the mistake of saying that it is something outside of us that should be the object of our concerncarbon dioxide, acidified oceans, and so on. not so. the object of our concern should be us. the seeds of our vulnerability lie within ourselves, not the disturbed natural systems around us. (horton ) . while inspired by the planetary boundaries concept, horton and other public health professionals recognise the important role of health at the centre of the sustainability challenges. they see human and environmental health as two sides of one coin. this has culminated in the emergence of the concept of "planetary health", which is defined as "the health of human civilisation and the state of the natural systems on which it depends" (whitmee et al. ; see also myers ) . notably, the planetary health approach shifts a focus onto the quality of human life and the socio-political institutions that shape human responses to planetary threats (horton ) . a manifesto issued by horton and his colleagues summarises the underlying motives behind this new concept: planetary health is an attitude towards life and a philosophy for living. it emphasises people, not diseases, and equity, not the creation of unjust societies. we seek to minimise differences in health according to wealth, education, gender, and place. (horton et al. ). in a sense, this is a plea for seeing the climate and sustainability challenges through a lens of health. the health concept has been used in several different ways in the context of ecology and the environment (mallee ) . there are mounting concerns over the impacts of climate change on human health (watts et al. ). nonetheless, health seems to remain not a primary concern among sustainability researchers. and then, the world was struck by the covid- pandemic. now health is the basic question on everyone's mind. this may be a renewed opportunity to take more seriously the health perspective in sustainability research. the concept of planetary health can provide a common language for transdisciplinary approaches to bridging a gap between environmental sustainability and public health. health can be used as an eclectic concept that combines the diverse ways of knowing from different strands of disciplines and concerns. according to the who definition, health is not merely the absence of disease but "a state of complete physical, mental and social well-being" (who ) . during the pandemic, the people's health is affected not only by the virus itself but also by the measures for controlling the virus. therefore, a pandemic response must look beyond the virus and carefully look at the social and economic dimensions of illness. it is required to address both the clinical care of symptoms and the societal roots of illness (mendenhall ) . crucially, the effects of the pandemic depend more on the pre-existing social conditions of countries than on the biological nature of the virus. the coronavirus pandemic turned into a serious economic crisis because the political economy before the pandemic (e.g. a decade-long austerity, a growth in insecure job employment) allowed the virus to deprive economically precarious people of their livelihoods (mckee and stuckler ). one of the most striking paradoxes of the covid- response is that those who work at low-skilled jobs were suddenly seen as "essential workers" during the lockdown. while these "essential workers" needed to keep going out to maintain the functioning of social systems, the wealthier individuals who are usually most mobile in normal times became least mobile during the lockdown because they could afford to self-quarantine at home (weill et al. ; see also bonaccorsi et al. ) . put simply, social distancing is the privilege of the rich while the poor suffer from it. the virus has thus revealed the egregious socio-economic inequalities within and between countries (zinn ). there is already abundant evidence that the coronavirus disproportionately affected the most socially marginalised groups-racial minorities (yancy ), temporary migrant workers (koh ) , sex workers (platt et al. ), prisoners or persons in custody (kinner et al. ) , homeless people (tsai & wilson ) , and so on and so forth. domestic violence against women has soared around the world since lockdowns began (wenham et al. ) . in developing countries, lockdowns would do more harm than good to the people in poverty, especially children (broadbent et al. ) . the immediate, medical losses directly associated with covid- are countable, if not completely, as shown by the fatalities statistics. however, the long-term consequences of structural social inequalities worsened by the pandemic are difficult to measure numerically, and hence often tend to "kill silently" (zinn ). an early policy response to the pandemic that focused upon "flattening the curve" of viral spread, informed primarily by mathematical models, failed to take into account the wider social and economic costs of lockdowns (caduff ) , which are necessarily conditioned by pervasive inequalities. this policy failure to address social inequalities might partly explain a recent global surge in anti-racism protests by the black lives matter (blm) movement in the wake of the killing of george floyld, an african american male who also lost his job due to stay-at-home orders in minnesota, the us. the protest for racial justice under the pandemic somewhat resonates with the fridays for future (fff) movement, the global youth strike for climate justice, inspired by greta thunberg. as an outrage at unjust treatment by police against black americans brought many people into the streets, a sense of injustice to future generations mobilised young people to walk out of school to fight for the climate. both anti-racism and climate protests represent "moral outrage" against social injustice-an empathetic (not personal) anger about the unfairness and injustice (antadze ). they convey a moral emotion about the unfair treatment of the other. the two protests of blm and fff movements teach us how badly the politics failed to address socio-economic inequality in responding to the crises. these protesters are angry at the institutional disregard for the suffering of the most vulnerable in the society. they can be understood as an outcry against the "politics of apathy" (antadze ). the us president donald trump is the most outrageous example of such political apathy. but scientists are not free from any shadow of guilt. while scientists are instrumental to enacting a policy for reducing greenhouse gas emissions or controlling the virus spread, they might turn a blind eye to the existing social inequalities and the societal losses that are difficult to show in numbers. this is the fundamental ethical challenge that science is facing in the midst of social crises. vaccines would probably end the covid- pandemic at some point in the future but we do not have a vaccine for inequality. we also have to be vigilant about the possibility that the availability of a vaccine will cause new geopolitical tensions (fidler ) , which might end up in widening the divide between haves and have-nots. in addition to vaccine development, a decisive action on reducing inequality is required. if borrowed thunberg's phrase, we cannot solve the inequality without treating it as a crisis. a crisis of any kind tells eloquently who we are or what kinds of society we live in. a crisis is a "mirror into which we can look and see exposed both our individual selves and our collective societies" (hulme ). both climate change and the coronavirus pandemic attest to the fact that we are now living in the anthropocene, the era in which unsustainable growth of human activities has caused a significant change in the global environment. but at the same time, the two crises have exposed a deep, widespread inequality in the twenty-first-century society-a chronic social illness of our time. as inequality in society is intrinsically coupled with changes in the ecological condition (hamann et al. ) , addressing socio-economic inequality is imperative for global sustainability science. in light of this, we suggest the three research agendas for future climate and sustainability research after the pandemic. first, focus on health and well-being of the human systems-social, political and economic-and their interaction with the earth's natural systems. as argued above, the concept of planetary health, moving away from an obsession with planetary boundaries and climate tipping points, will provide a useful point of reference for interdisciplinary and transdisciplinary research that can cut across traditional boundaries between environmental sustainability and public health. the health perspective is, for example, instrumental in better integrating the risk of emerging infectious diseases within sustainable development planning (di marco et al. ) . strengthening health systems through universal health coverage is essential for several un sustainable development goals (sdgs), such as no poverty, quality education and gender equality (kieny et al. ) . since health and equality are closely linked to each other, protecting human and environmental health is conducive to the central pledge of sdgs: "leave no one behind". second, sustainability research needs to have a moral engagement with the "unknown other" through empathy (antadze ). as antadze ( ) noted, a new reality in the age of the anthropocene requires us to rethink the nature of togetherness as an openness to the other who is unknown but may suffer the unfair consequences of our own actions. the totality of climate change and global pandemic means that we have to take responsibility for the suffering of the other and develop an imaginative capacity through empathy to emotionally engage with the other. empathy is sharing of another's emotional state or putting oneself in someone's shoes. however, sustainability science so far appears to turn away from empathising with the people's sufferings in real life. now is a time of reckoning. scientists should hold up mirrors which reveal the contradictions and limitations of and within science, including systemic racism in science (nature ; thorp ). by doing so, sustainability research should have a new normative commitment to building collective empathy for the vulnerable other. third, related to the second point, sustainability research needs a science of loss for managing grief (barnett et al. ). an uncomfortable, unsettling truth of climate change and global pandemic is that the loss of people, places, practices, and so many others is somewhat unavoidable. whilst the policy to prevent loss is no doubt needed, embracingrather than denying-the possibility of loss may perhaps help people better overcome or come to terms with grief and loss. a science of loss is to understand what kind of loss would be intolerable to people, how a loss might arise through changes in the natural environment and, when the loss is unavoidable, help people to manage grief and remember loss (barnett et al. ) . importantly, as barnett et al. ( ) said, many phenomena that people value are often incommensurable with no possible substitutes; hence, there can be no effective compensation for their loss. as the new york times wrote in an obituary of a hundred thousand lives lost to coronavirus, it is an "incalculable loss". to condole with the people in grief can be the role of science. this means that the research has to go further into an emotional engagement with stakeholders, more than just that for producing knowledge, at which is often aimed in transdisciplinary sustainability research (lang et al. ) . taken together, a crisis necessitates a transformation of the science toward more socially and ethically engaged research. the coronavirus crisis has put a normal life of people on hold, requiring to not go back to the old normal but move onto the new normal. with a sense of urgency of the climate crisis, many people understand the politics must go beyond business as usual. likewise, this is-and should be-a moment of change in our way of doing the science in times of crisis. it will be a moral failure of the science to keep ignoring the "black elephant" in an emergency room. acknowledgement the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/ . /. modelling the pandemic: the simulations driving the world's response to covid- global hotspots and correlates of emerging zoonotic diseases the politics of apathy: trumping the ethical imperative of climate change who is the other in the age of the anthropocene? introducing the unknown other in climate justice discourse moral outrage as the emotional response to climate injustice successful elimination of covid- transmission in new zealand a science of loss climate for change, or how to create a green modernity? economic and social consequences of human mobility restrictions under covid- revisiting the one health approach in the context of covid- : a look into the ecology of this emerging disease lockdown is not egalitarian: the costs fall on the global poor what went wrong corona and the 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ecological, and sustainability sciences to manage emerging infectious diseases a monstrous threat": how a state of exception turns into a "new normal key: cord- -qhyjhk r authors: wissow, lawrence s.; platt, rheanna; sarvet, barry title: policy recommendations to promote integrated mental health care for children and youth date: - - journal: acad pediatr doi: . /j.acap. . . sha: doc_id: cord_uid: qhyjhk r nan public health and health care systems face many challenges as indicators of acuity and demand for child mental health services increase. , , these systems have not been designed to detect problems early and intervene with potentially preventive interventions. , in addition, the child mental health workforce lacks sufficient capacity as it is presently configured. integration of mental health services into primary care has been promoted as one answer to these challenges, and is endorsed by national and international organizations. , nearly all children have primary care visits, and the philosophy of pediatric primary care in the us is oriented toward universal prevention, surveillance, and early intervention. primary care providers are seen as credible sources of psychosocial information and guidance, and many families express a preference for getting psychosocial care in a primary care rather than a mental health setting. some of this preference comes from primary care being a more familiar and potentially less stigmatizing place to receive mental health care, a factor that may be especially salient to patients who already experience racial or ethnic stigma. incorporating mental health as part of "routine" medical care also sends a message that emotional well-being is an essential part of one's overall wellness. prior to the beginning of this century, very few pediatricians worked in close coordination with mental health professionals. despite evidence that child/youth integrated care can be effective and practical, , still only about half of us pediatricians consider that they work in practices co-located with a behavioral health professional. integration continues to face significant barriers, including lack of consensus on how primary care and co-located mental health professionals should share roles, the need for substantial transformation in how practices operate if they are to provide mental health care, financing schemes that do not incentivize treatment in primary care or collaboration with mental health providers, and a lack of mental health practitioners trained to work in primary care settings (especially in linguistically and culturally diverse communities). , to these structural barriers, however, additional dilemmas have emerged as the field of integrated care has evolved. first, there is the realization that conceptualizing integrated care as a binary partnership between mental health and primary care does not address the high level of co-occurrence of mental health, developmental, and psychosocial problems that limit the effectiveness of mental health treatments when they are applied in isolation. as the us and much of the world enter into an era of unprecedented social and economic challenge related to the novel coronavirus, which has disproportionately impacted populations already experiencing limited access to mental health services, the need to expand the scope of integration will only become greater. second, there is the difficulty of translating the most widely known models of integrated care, developed in adult medicine, into pediatrics. compared to adult integrated care, child mental health integration must contend with presentations that vary significantly with age, which complicates screening and other forms of case-finding. child mental health treatment relies more on brief, practical psychosocial interventions compared to easier-to-deliver medication titration. , in addition, while nearly everyone's mental health is related to that of the people they live with, children's mental health outcomes are particularly dependent on their parents' own mental health, and thus treatment often must include plans to address parents' treatment needs and parent-child interactions. the american academy of pediatrics has issued a policy statement outlining what it sees as pediatric providers' responsibilities to address parental mental health, but there remains little precedent for directly addressing parent mental health in pediatric primary care, despite its profound effects on children. to date, integrated care has benefited from attempts at federal, state, and professional society levels to promote its implementation. with some exceptions, however, such as the centers for medicare and medicaid services' inck initiative, and efforts by the american board of pediatrics and the american academy of pediatrics, , , there has been a greater emphasis on doing so with care for adults. . other policy analyses have addressed how health systems as a wholeincluding those with integrated care components, can promote child and family well-being in general. the following recommendations focus more narrowly on integrating mental health into pediatric primary care. the recommendations are intended as a guide to policymakers, health system leaders and educators, and research funders; they address four goals that, based on the analysis above, we believe are central to the growth and effectiveness of pediatric integrated care: first and foremost, policies must promote changes in the scope of pediatric primary care so that it can comprehensively address families' psychosocial needs. multi-generational social and emotional wellness needs to be accepted as an integral part of pediatric care and these aspects of health need to be effectively assessed and treated by pediatricians and/or in collaboration with community-based services that address social determinants of health. , state and federal programs have the ability to influence these transformations through regulatory changes, financial incentives, and corresponding technical assistance. individual providers and health care organizations need the clear guidance, motivation and knowledge of how to go about modifying their practices and building the community alliances they will need to provide truly integrated care. requiring health care systems to report mental health-related metrics will allow state and federal authorities to optimally leverage incentives. specific initiatives could include: a. federal and/or state incentives for implementing "advanced medical home" or "high performing medical home" , models that are foundations for integrated care. states can support these models by giving practices additional payments if they meet criteria for certification (see financing recommendations below). incentives could be tailored to reward the use of integrated care to address disparities in mental health services and outcomes, as well as to reward coordination of child/youth and adult mental health services. b. the federal government could expand past policy statements regarding the detection and treatment of parental mental health problems as part of pediatric primary care. expansions could include that attention to parental mental health extends beyond concern for maternal depression in the perinatal period, as well as stating the appropriateness of including relevant parent mental health information in the child's medical record. these statements, coupled with increased training for pediatricians in the detection and initial assessment of parental health issues, could help to clearly include attention to parental mental health as within the scope of pediatric practice. d. hrsa could expand and institutionalize its support so that all states could have so-called "child psychiatry access programs" that promote interprofessional collaboration and education supporting mental health service delivery in the pediatric primary care. , these programs provide informal mental health consultation to primary care providers around specific patient's problems, and many currently have primary care provider training and practice transformation components which could be expanded to include helping integrated behavioral health providers (including those in schools) adopt and use evidencebased brief interventions or telepsychiatry when necessary. coordinated with these "access programs," states, health care organizations, and philanthropy could fund additional mental health skills training for primary care providers, taking advantage of the "access programs" ability to provide long-term, ongoing consultation and support for practice c. states can expand the use of billing codes that support collaborative work so that both primary care and psychiatric providers can be paid for indirect consultation, case review, and coordination of referrals for both children and parents. as part of paying for collaborative care, states can also allow billing for the services of community health workers or navigators who can link families to needed follow-up services and reinforce/deliver mental health treatments (see below in workforce). d. the federal government and private insurers could allow wider latitude for billing for parent-directed services that also have potential for impact on the child. third, policies need to encourage development of the workforce so that integrated care can be delivered at scale. not only is there a general lack of child mental health workforce in most areas of the country, there is an even greater lack of providers trained to work at the interface of medicine, mental health, and community supports. , , in our increasingly diverse society, this workforce has to speak multiple languages and be capable of delivering care to families from multiple cultures. a. the federal government, states, and philanthropy could subsidize mental health training for peer/community health workers/navigators who would ideally be recruited from diverse communities and whose services could be paid for through medicaid prevention or case management mechanisms. , subsidies to payers or health care providers could be tied to increasing the linguistic and cultural diversity of the workforce and providing long-term career pathways for those who start out in these important but entry-level positions. , b. states could finance additional residency/fellowship slots in pediatrics, family practice, and child psychiatry that focus on integrated care. c. states could require exposure to integrated care skills and meaningful training in mental health for any existing slots that the state currently funds, especially those aimed at producing physicians who will go into primary care. states would have more leverage if medical education accreditation and licensing bodies required robust mental health curricular components in training programs for all primary care disciplines including mds, dos, physicians assistants and nurse practitioners. d. states could additionally finance slots or tracks in nursing (including advanced practice), social work, and psychology, programs that target work in co-located or community settings. , finally, research dollars are needed to develop the case-finding methods and interventions that will bring pediatric integrated care to its full potential. this includes further development of screening processes that promote actionable discussions with families about their psychosocial strengths and weaknesses, trans-diagnostic and trans-system (medical and social) approaches to treatment, , more potent and deployable psychotherapeutic interventions suitable for primary care (including those that specifically address parent-child interaction), a. development and testing of brief, broadband (trans-diagnostic) therapies that can be readily learned by individuals with and without formal mental health training and that can be delivered to families in a variable number of short sessions. , b. adaptation of parent support and parent-child interaction interventions for primary care, both in early childhood and across the pediatric age range. , c. investigation of alternative models of well-child care (such as group visits) that recognize the priority within well-child care for supporting the mental health and psychosocial needs of families. , d. exploration of novel uses of ehealth for providing integrated care services, including expanded use of telemedicine, the use of follow-up text messages and other modalities to prolong the impact of brief in-person mental health interventions, and the integration of on-line treatments for parents and other caregivers into services based in pediatrics. , e. development of efficient training and ongoing support programs for community health workers, peer navigators, and others who can both extend the mental health workforce and increase its capacity for providing care in diverse languages and from diverse cultural perspectives. , f. studying processes related to practice transformation and interaction across systems, with particular focus on ) methods for including diverse families in the design and adaptation process of interventions, and ) efficient methods for providing initial and long-term assistance to practices and systems as they implement and refine integrated care. integrated care is considered to be one of the most promising directions for addressing inadequacies in the delivery of child and youth mental health services. it offers the opportunity to build problem detection and early intervention into an existing system of child health monitoring and promotion, as well as to create a greatly expanded number of sites where child and youth mental health care can be delivered. however, growth of pediatric integrated care continues to face barriers built into the way that pediatric primary care is delivered and financed. policies need to support transformations in the scope of pediatric primary care, as well as financing mechanisms that make these transformations sustainable. a larger and more diverse mental health workforce will be needed to support an expansion of pediatric integrated care. training programs for both primary care providers and a variety of current and potential mental health providers must provide clinicians with the skills they need to engage and help families in the primary care setting. finally, there remains much to be learned about interventions that could make pediatric integrated care more potent and easier to implement. fortunately, there are strong foundations on which to address all of these needs; it should be possible to coordinate efforts in these directions and move pediatric integrated care forward at a time when it is particularly needed. time trends in symptoms of mental illness in children and adolescents in canada trends in psychiatric emergency department visits among youth and young adults in the us years in the united states primary health care: potential home for familyfocused 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care: a blueprint for leveraging medicaid and chip to finance change behavioral health integration in pediatric primary care: considerations and opportunities for policymakers, planners, and providers integrated pediatric behavioral health: implications for training and intervention models community health workers for patients with medical and behavioral health needs -challenges and opportunities mental illness and well-being: an affect regulation perspective improving parenting skills for families of young children in pediatric settings: a randomized clinical trial prime: a programme to reduce the treatment gap for mental disorders in five low-and middle-income countries a single-session growth mindset intervention for adolescent anxiety and depression: -month outcomes of a randomized trial enhancing parent talk, reading, and play in primary care: sustained impacts of the video interaction project well-child care clinical practice redesign for serving low-income children a telehealth-enhanced referral process in pediatric primary care: a cluster randomized trial a computer-assisted depression intervention in primary care lay counselor perspectives of providing a child-focused mental health intervention for children: task-shifting in the education and health sectors in kenya. front psychiatry ensuring quality in psychological support (who equip): developing a competent global workforce transforming physician practices to patientcentered medical homes: lessons from the national demonstration project co-designing an intervention to prevent overweight and obesity among young children and their families in a disadvantaged municipality: methodological barriers and potentials change in patient outcomes after augmenting a low-level implementation strategy in community practices that are slow to adopt a collaborative chronic care model: a cluster randomized implementation trial the authors are grateful to drs. marian earls, jane foy, j. david hawkins, and robert hilt for suggestions as we compiled this set of policy goals and recommendations. key: cord- -l xuu a authors: bergström, anna; ehrenberg, anna; eldh, ann catrine; graham, ian d.; gustafsson, kazuko; harvey, gillian; hunter, sarah; kitson, alison; rycroft-malone, jo; wallin, lars title: the use of the parihs framework in implementation research and practice—a citation analysis of the literature date: - - journal: implement sci doi: . /s - - - sha: doc_id: cord_uid: l xuu a background: the promoting action on research implementation in health services (parihs) framework was developed two decades ago and conceptualizes successful implementation (si) as a function (f) of the evidence (e) nature and type, context (c) quality, and the facilitation (f), [si = f (e,c,f)]. despite a growing number of citations of theoretical frameworks including parihs, details of how theoretical frameworks are used remains largely unknown. this review aimed to enhance the understanding of the breadth and depth of the use of the parihs framework. methods: this citation analysis commenced from four core articles representing the key stages of the framework’s development. the citation search was performed in web of science and scopus. after exclusion, we undertook an initial assessment aimed to identify articles using parihs and not only referencing any of the core articles. to assess this, all articles were read in full. further data extraction included capturing information about where (country/countries and setting/s) parihs had been used, as well as categorizing how the framework was applied. also, strengths and weaknesses, as well as efforts to validate the framework, were explored in detail. results: the citation search yielded articles. after applying exclusion criteria, articles were read in full, and the initial assessment yielded a total of articles reported to have used the parihs framework. these articles were included for data extraction. the framework had been used in a variety of settings and in both high-, middle-, and low-income countries. with regard to types of use, % used parihs in planning and delivering an intervention, % in data analysis, % in the evaluation of study findings, and/or % in any other way. further analysis showed that its actual application was frequently partial and generally not well elaborated. conclusions: in line with previous citation analysis of the use of theoretical frameworks in implementation science, we also found a rather superficial description of the use of parihs. thus, we propose the development and adoption of reporting guidelines on how framework(s) are used in implementation studies, with the expectation that this will enhance the maturity of implementation science. there has been an increased use of theoretical frameworks in the field of implementation science in the last decade, with most developed in the last two decades [ , ] . tabak et al. identified theoretical models used in dissemination and implementation science [ ] . however, while theoretical frameworks are increasingly being cited, more research is needed to understand how they are chosen and applied, and how their use relates to improved implementation outcomes [ , ] . variously described in the form of theories, frameworks, or models, all strive to provide conceptual clarity on different aspects of implementation practice and research. for consistency, we will refer to these as theoretical frameworks, or simply "frameworks." the promoting action on research implementation in health services (parihs) framework is a multidimensional framework which was developed to explicitly challenge the pipeline conceptualization of implementation [ ] . the parihs framework is a commonly used conceptual framework [ , ] that posits successful implementation (si) as a function (f) of the nature and type of evidence (e) (including research, clinical experience, patient experience, and local information), the qualities of the context (c) of implementation (including culture, leadership, and evaluation), and the way the implementation process is facilitated (f) (internal and/or external person acting as a facilitator to enable the process of implementation); si = f(e,c,f). the framework was informed by rogers' diffusion of innovations [ ] and various organizational theories and theories from social science [ ] and generated inductively by working with clinical staff to help them understand the practical nature of getting evidence into practice. the parihs framework was initially published in [ ] and updated based on a conceptual analysis in [ ] and further primary research [ ] . a further refinement was undertaken in [ ] , resulting in the integrated or i-parihs. articles using the revised version are not included in the citation analysis reported here. the parihs framework has been described as a determinant framework in that it specifies determinants that act as barriers and enablers influencing implementation outcomes [ ] . skolarus et al. [ ] identified kitson et al. [ ] as one of the two primary originating sources of influence in their citation analysis of dissemination and implementation frameworks. despite the growing number of citations of theoretical frameworks in scientific articles, the detail of how frameworks are used remains largely unknown. systematic reviews of the application of two other commonly used frameworks [ ] , the knowledge to action framework [ ] and the consolidated framework for implementation research [ ] , both reported that use of these frameworks, beyond simply citation, was uncommon. while parihs has been widely cited, it has also been scrutinized; in , helfrich et al. published a qualitative critical synthesis of studies that had used the par-ihs framework [ ] , finding six core concept articles and empirical articles. one of the reported findings was that parihs was generally used as an organizing framework for analysis. at the time, no studies used parihs prospectively to design implementation strategies [ ] . a systematic review applying citation analysis to map the use of parihs (similar to those undertaken for the knowledge to action framework (kta) [ ] and the consolidated framework for implementation research (cfir) [ ] ) has not yet been performed. systematic reviews can contribute to the development of existing theoretical frameworks by critically reviewing what authors state as their weaknesses and strengths; they can also direct future and current users of frameworks to examples of using the frameworks in different ways. to contribute to this development from the perspective of the parihs framework, we undertook a citation analysis of the published peer-reviewed literature that focused on the reported use of parihs (and its main elements), in what contexts the framework has been applied, and what scholars who have used the parihs framework (and its main elements) report as its strengths, limitations, and validity. the method used for this study is citation analysis, i.e., the examination of the frequency and patterns of citations in scientific articles, in this case articles citing the core parihs framework publications. a team of researchers with engagement in the development and/or use of the parihs framework was constituted. initially, the group decided on the core publications for the citation analysis. four articles were selected as they represented the key stages of the framework's development, namely the original paper that described parihs, plus • the findings underline that descriptions of the use of the framework generally were not that transparent and often partial. • findings also point at difficulties in using the framework, such as lack of guidance on key steps to overcome barriers and support implementation • identifies the need of common guidelines on how theories, models, and frameworks should be reported in research articles. citation searches were performed by an information specialist (kg) to retrieve published articles citing any of the four core articles. the searches were performed in two citation databases: web of science and scopus. the first searches were performed between march and april . later, september , additional searches were performed in respective databases. these searches were limited to citations that were published april - august to update the result from the first searches. all citations that were published september (i.e., when kitson et al was published)- august (i.e., prior to the search date) in respective databases were collected in endnote library. endnote was used for checking duplicates and retrieving full texts. to manage the scope of the citation analysis, we opted to only include articles in english published in peer-reviewed scientific journals. the searches in web of science were, because of the subscription, limited to web of science core collection without book citation index. the preferred reporting items for systematic reviews and meta-analyses (prisma) flow diagram [ ] for the data extraction is provided in fig. . initially, an assessment to identify the articles that used the parihs framework in any other way than merely referencing one or more of the core articles was performed (additional file ). for this initial assessment, all articles were read in full. after identifying articles where the parihs framework was used, data extraction was undertaken using a tailor-made data capture form (additional file ). the data capture form was developed and piloted in iterative cycles by the research team. apart from capturing information about where (country/countries and setting/s) and with whom (professional groups and roles) parihs had been applied, the form included questions on whether parihs was used in one or more of the following ways: ) in planning and delivering an intervention, ) in data analysis, ) in the evaluation of study findings, and/or ) in any other way. each of these questions was followed by an openended item for extracting information on how this was reported [ ] . to enhance reliability and data richness, each reviewer copy-pasted sections of the article corresponding to the open-ended reply into the data extraction form when appropriate and indicated page, column, and row. two additional items captured whether the parihs framework had been tested or validated, as well as any reported strengths and weaknesses of the framework. thus, we report on what the authors of the included articles claim to have done, rather than a judgment as to how and to what extent they actually used the parihs framework. for data extraction and validation, the research team was divided into four pairs, ensuring that each article was assessed separately by at least two research team members. the pairs received batches of articles at a time. variations in the assessments were discussed until consensus was reached within the pair(s). further, queries detected within the pairs were raised and discussed with the whole research team, until consensus was achieved. regular whole-team online meetings were held to consolidate findings between every new batch of articles and throughout the development and analysis process. in total, the group had > online meetings and four face-to-face meetings from the initial establishment of the group in january . categorical data were analyzed using descriptive statistics, whereas the open-ended items were analyzed qualitatively [ ] , including the collated extractions of data to illustrate each of the four types of use (i.e., how the parihs framework was depicted in terms of ( ) planning and delivering an intervention, ( ) analysis, ( ) evaluation of study findings, and/or ( ) in any other way). applying a content analysis approach [ ] , members of the research team worked separately with the texts extracted from the reviewed articles. the extracts for each open-ended item were read and reread, to get a sense of the whole. next, variations were identified and formed as categories. findings for each question were summarized in short textual descriptions, which were shared with the whole team. in a face-to-face meeting, the data relating to each question were critically discussed and comparisons were made between the findings for each question, to identify overlaps and relationships about how parihs has been used. after duplicate control, references remained. these were sorted by language and type of publication. in this phase, references categorized as books, book chapters, conference proceedings, and publications written in non-english language were excluded. also, three of the four core articles (i.e., the three citing kitson et al. [ ] which was the starting point for development of the parihs framework and therefore did not appear in the citation search) were excluded from the database [ , , ] , as were four articles expanding and refining par-ihs [ ] [ ] [ ] [ ] . accordingly, articles remained, and after the assessment excluding those merely citing par-ihs, a further articles were excluded, leaving articles that cited one or more of the core articles, and made explicit use of the parihs framework (see fig. and table ) . of these articles, cited kitson et al. [ ] , cited kitson et al. [ ] , cited rycroft-malone et al. [ ] , and cited rycroft-malone et al. [ ] . in total, the articles consisted of protocols [ , , , - , , , - , - , , ] . a further articles reported empirical studies: ▪ where parihs guided the development of the intervention [ - , - , , , - ] , ▪ intervention studies where parihs did not guide the development of an intervention [ , , , , , , , , , , , , , , - , , - , - , , , , , - , , - , - , - , , , - , , , , - , , , - , - , , , - , - ] , ▪ non-intervention studies [ , , , , , , - , , , - , , , , - , - , , , , , , , , - , - , - , , , , , , , , , , , - , , ] in addition, the database included empirical review studies [ , , , , ] and opinion/ theoretical articles [ , , . in terms of professional focus, about % of the included articles involved nursing. in the following sections, references have been added to the categorical items in the data extraction while we have opted only to provide examples of references to the findings from the qualitative exploration of how the parihs framework was operationalized in detail. of the articles reporting type of setting where the implementation project/research took place, a majority were undertaken in hospitals (n = ) [ , , , , , , , , , - , , - , , - , , , , , , - , , , , , - , - , , , , , , , , , , , - , , , , - , , , , - , , , - , , , , , , , , , , , , , , - , , , , , , , - , - , , , , - , , , , , , , , , , , , , , , , , , ] , followed by a combination of multiple healthcare settings (n = ) [ , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , - , , , , , , , , , , , , , , , , , , , , - , , , , , , , , , , , , , , , , , , , , ] , community/social care settings (n = ) [ , , , , , , , , , , , - , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ] , primary health care (n = ) [ , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ] , and home-based care (n = ) [ , , , , , , ] . five articles were derived from special settings such as construction [ ] , education [ ] , pharmacies [ ] , urban planning [ ] , and public health institutions [ ] . in articles [ , , , , , , , , , , , , , , , , , , , , , , - , - , , , , , , , , , , , , , , ] , the setting was not reported or not applicable (e.g., opinion/theoretical articles). for empirical studies and published protocols, about % were derived from research in the usa, % from canada, % from sweden, and % from the uk. the remaining articles mainly originated from other high-income countries in europe; in addition, there were a few articles reporting studies in low-and middle-income countries, including vietnam, tanzania, mozambique, and uganda [ , , , , , ] . the types of articles published using the parihs framework changed over time, with an increase in the number of empirical studies from onwards, as illustrated in fig. . as the search for articles for this review only included the first eight months of , the graph is limited to full years (i.e., through ). figure depicts how parihs was used by type of article. although authors frequently claimed that parihs was used in one or more ways, details as to how the framework was used were often lacking. in total, ( %) articles claimed to use the parihs framework to plan and deliver an intervention [ - , - , - , , , , , - ] . predominantly, these were empirical studies (n = ) [ - , - , , , - ] but also two opinion/theoretical articles [ , ] and protocols . of the articles, about half stated that the framework was used for theoretically informing, framing, or guiding an intervention (e.g., [ , , , , ] ). however, in these studies, parihs was referred to only in a general sense, in that the core elements of the framework were said to have informed the planning of the study. there was a lack of detail provided about what elements of the framework were used and how they were operationalized to plan and deliver an intervention. in the other half of the articles, it was described more specifically that one or more elements of the framework had been used. most commonly the facilitation element (e.g., [ , , , , ] ) was referred to as guiding an implementation strategy. the articles that provided explicit descriptions of interventions using facilitation employed strategies such as education, reminders, audit-andfeedback, action learning, and evidence-based quality improvement, and roles including internal and external facilitators and improvement teams to enable the uptake of evidence (e.g., [ , , , ] ). some articles drew on the parihs framework more specifically, to understand the role of organizational context in implementation (e.g., [ , , , ] ). there were ( %) articles where the parihs framework was reported to be used in the analysis [ , , - , - , - , - , - , , , - , , - , , ] . most of these involved empirical studies (n = ) [ - , - , - , ] where parihs often was described as guiding or framing the data collection, e.g., developing an interview guide, and/or analysis, but with no further details. in articles that provided more detailed information, parihs was used to guide or frame qualitative analyses in about studies (e.g., [ , , , , ] ). of these, around used a deductive approach in that they used the elements and sub-elements to structure the analytic process (e.g., [ , , , , ] ). about studies applied parihs for quantitative analysis, (e.g., [ , , , , ] ). in half of these, the alberta context tool (e.g., [ , , , , ] ) and the organizational readiness to change assessment tool (e.g., [ , , , ] ) were used; both these tools being derived from parihs. empirical studies using the parihs framework in the analysis encompassed primarily all three main elements of parihs (e.g., [ , , , ] ) and the context domain (e.g., [ , , , ] ), and in lesser extent the evidence (e.g., [ , , ] ) and the facilitation domain (e.g., [ , , , ] ). eleven review studies [ , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] used the framework for the analysis; findings were mapped to parihs elements in a few studies [ , , ] ; one described that their data had been "analysed through the lens of parihs" (p ) [ ] . a couple of the review studies had parihs as the object for analysis, comparing it with other frameworks [ , ] . this approach was also common in the opinion/theoretical articles [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , where the parihs framework itself was the focus of the analysis (e.g., [ , , ] ). in these articles, the analysis was performed in different ways, primarily through mapping and comparing parihs to other frameworks or models or even policies, but also for general discussions on implementation and evidence-based practice. among the articles that reported using the parihs framework in the analysis, there were also protocols where authors reported that the intention was to use the framework in the analysis [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the application of parihs in the evaluation of study findings a total of ( %) included articles provided information on how the parihs framework was used in the evaluation of study findings, in terms of contributing to the discussion and interpretation of results [ , , - , - , - , - , - , - , , , - , - , , - , - , , ] . the majority (n = ) of these were empirical studies [ , - , - , - , - , - , - , ] . we found two main approaches to how the parihs framework was used in the evaluation of study findings. first, parihs was used to organize the discussion of the findings (e.g., [ , , , , ] ), where the framework and/or its elements were used to provide a structure for reporting or generally discussing the findings, or both, for example in stating that the key elements of parihs were reflected in the study findings. second, the framework was used to consider the implications of the study's findings (e.g., [ , , , , ] ), where the framework or its elements (varying between one (e.g., [ , , ] ), two (e.g., [ , , ] ), and all the three main elements (e.g., [ , , ] )) enabled authors to elaborate on findings, or reflect on the implications of their study to evaluate the parihs framework itself. specifically, we found some empirical articles reported evaluating the parihs element "context" by means of context tools (e.g., [ ] ). in addition, an evaluation of the study findings using the framework was identified in opinion/theoretical articles [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] and empirical review studies [ , , , - , - , ] . among the opinion/ theoretical articles, there were papers evaluating other theoretical constructions in relation to the parihs framework (e.g., [ ] ). a total of ( %) reported using parihs in some other way than directly informing the planning and delivery of an intervention or analyzing and evaluating findings [ , - , , , - , - , , - , - , , - , - , - , - , , , - , , - , - ] . a majority of these articles (n = ) were empirical studies [ - , , - , - , - , - , - , - ] , and about half of these described the use of par-ihs as an overall guide to frame the study (e.g., [ , , , , , ] ). a similar finding was apparent in the protocols [ - , , , - , , ] ; about half of these also referred to the use of parihs to guide and frame the study design (e.g., [ , , , ] ). an alternative use of parihs in empirical studies involved focusing on one of the three parihs elements (n = ) and investigating them in greater depth, most notably context (n = ) (e.g., [ , ] ) and facilitation (n = ) (e.g., [ , ] ). a total of opinion/theoretical articles [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] reported using the parihs framework in some other way, including a discussion about parihs as part of presenting a general overview of theories and frameworks to inform implementation (e.g., [ , , , ] ), using parihs to augment, develop, or evaluate other implementation models and frameworks (e.g., [ , , , , ] ), and informing education and learning and teaching initiatives [ , ] . empirical review articles (n = ) included reviews of implementation frameworks [ , , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] , including parihs, a review of the facilitation dimension of parihs and a discussion of the potential to combine implementation and improvement methodologies. testing and providing views on the validity of the framework a total of ( %) articles described testing or validating parihs, or provided comments on the validity of the framework [ , , , , , , , , , , , , , , , - , , , , , , , , , , , , , , , , , - , , , , , - , , , , , , , , , , - , , , , , , , , , , , , , , , , , , , , , , - , , , , , , , , , , , - , , , , , , ] . of these, were empirical studies [ , , , , , , , , , - , , , , , , , , , , , , , , , , , - , , , , , - , , , , , , , , , , - , , , , , , , , , , , , , , , , , , , , , ] , five were study protocols [ , , , , ] , opinion/theoretical articles [ , , - , , , , , ] , and empirical reviews [ , , , - , , , , , , , , ] . empirical studies either tested the whole or parts of the framework with a focus on: ▪ the validity of the whole framework (e.g., [ , , , , ] ) ▪ the validity of context (e.g., [ , , , , ] ) ▪ the validity of facilitation (e.g., [ , , , ] ) ▪ the validity of evidence (e.g., [ ] ) ▪ identifying gaps in the framework (e.g., [ , , ] ) over the review study period ( to ), among empirical studies, there was a shift from primarily studying the context element of the framework to more articles evaluating the whole framework. this was also evident in the pattern found in the protocols, which mostly focused on testing facilitation (e.g., [ , , ] ). opinion/theoretical articles tended to critique the whole framework (e.g., [ , , , , ] ). of the empirical reviews, the majority focused on the whole framework (e.g., [ , , ] ), then on context (e.g., [ , , ] ) and then on facilitation (e.g., [ ] ). of note is the lack of attention in the literature to the element of "evidence" in the parihs framework (examples of articles paying attention to evidence include [ , ] ). the articles varied in detail, depth, and quality in terms of descriptions of how they went about testing the validity of the parihs framework. approaches ranged from general observations of whether the research teams/users found the elements and sub-elements easy to use (e.g., [ , , ] ), to studies that used elements of context described in the parihs framework to validate new context measures across settings and groups (e.g., [ , , ] ). as one example, the alberta context tool started from the parihs conceptualization of context to include dimensions of culture, leadership, and evaluation. regarding the strength and limitations of the parihs framework, about one third of the included articles reported on its strengths and about % commented on perceived limitations. the identified strengths included: ▪ holistic implementation framework (e.g., [ , , , ] ) that is perceived as intuitive and accessible. ▪ both practical and theoretical and therefore feasible to use by both clinicians and researchers; also seen as intuitive to use and accessible (e.g., [ , , ] ). ▪ can be used as a tool: diagnostic/process/evaluative tool; predictive/explanatory tool or as a way to explain the interplay of factors (e.g., [ , , , , ] ). ▪ can accommodate a range of other theoretical perspectives (including approaches such as social network theory, participatory action research, coaching, change management and other knowledge translation frameworks) (e.g., [ , , , ] ). ▪ can be used successfully in a range of different contexts (low-and middle-income countries) [ ] and services and for various groups of patients (disability, aged care) (e.g., [ , , , ] ). limitations of the parihs framework included: ▪ poor operationalization of key terms leading to difficulties in understanding and an overlap of elements and sub-elements (e.g., [ , , ] ). ▪ lack of practical guidance on steps to operationalize the framework (e.g., [ , ] ) with a subsequent lack of tools. ▪ lack of information on the individual and their characteristics (e.g., [ , ] ) and their lack of understanding of evidence (e.g., [ , ] ). ▪ too structured and does not acknowledge the multidimensionality and uncertainty of implementation (e.g., [ , ] ). ▪ lack of acknowledgement of wider contextual issues such as the impact of professional, socio-political, and policy issues on implementation (e.g., [ , , , ] ). ▪ not providing support in how to overcome barriers to successful implementation (e.g., [ ] ). in a recent survey among implementation scientists, the parihs framework was found to be one of the sixth most commonly used theoretical frameworks [ ] . yet, in our review, about % (n = ) of the identified articles citing any of the four selected core parihs articles used the framework in any substantial way. similarly, a review of the cfir found that / ( %) of articles citing the framework were judged to use the framework in a meaningful way (i.e., used the cfir to guide data collection, measurement, coding, analysis, and/or reporting) [ ] . a citation analysis of the kta framework found that about % ( / ) of screened abstracts described using the kta to varying degrees, although only articles were judged to have applied the framework in a fully integrated way to inform the design, delivery, and evaluation of implementation activities [ ] . parihs has been used in a diverse range of settings but, similarly to other commonly used implementation frameworks, most often superficially or partially. the whole framework has seldom been used holistically to guide all aspects of implementation studies. implementation science scholars have repeatedly argued that the underuse, superficial use, and misuse of implementation frameworks might reduce the potential scientific advancements in the field, but also the capacity for changing healthcare practice and outcomes [ ] . the rationale for not using the whole parihs framework could be many, including the justified reason of only being interested in a particular element. as such, partial use cannot always be considered as inappropriate. simultaneously, many researchers entering the field might be overwhelmed with the many frameworks available and the lack of guidance about how to select and operationalize them and using their elements [ , , ] . the current citation analysis can thus help remedy a gap in the literature by revealing how the parihs framework has been used to date, in full or partially, and thus provides input to users of its potential use. the use of theoretical frameworks in implementation science serves the purpose of guiding researchers' and practitioners' implementation plans and informing their approaches to implementation and evaluation. this includes decisions about what data to gather to describe and explain implementation, their hypotheses about action steps needed, how to account for the critical role of context, and providing a foundation for analysis and discussion [ ] . the advancement of theoretically informed implementation science will, however, depend on much improved descriptions as to why and how a certain framework was used, and an enhanced and betterinformed critical reflection of the functionality of that framework. this review shows that the parihs framework has rarely been used as a whole; rather, certain elements tend to be applied, often retrospectively as indicated in fig. underlining the use of parihs in the evaluation of study findings, which resonates with the findings of reviews about the use of the kta [ ] and cfir [ ] frameworks. this could be as a result of a lack of theoretical coherence of some frameworks making them difficult to apply holistically, and/or a function of a general challenge that researchers face in operationalizing theory. however, this could also be a result of publishing constraints. while the parihs framework may have guided implementation or been implicitly used in the study design, it was rarely the focus of the publications. further, the aims and scopes of scientific health care journals have historically prioritized clinical outcomes over implementation outcomes where one could expect a more detailed description of the use of theoretical frameworks. this may have resulted in authors not fully reporting their use of, e.g., the parihs framework. the number of empirical studies using the parihs framework has steadily increased over the review period. there is also evidence to show that more research teams have contributed to critiquing the framework in terms of reporting on its strengths and limitations and its validity. the pattern of investigation is moving from studies on context, to more systematic explorations of facilitation, thus contributing to a more detailed understanding of the elements and sub-elements of the framework. the lack of focus on "evidence" identified in this review highlights the need for researchers and clinicians to focus on the multi-dimensionality of what is being implemented. common patterns emerging in this review support the changes made to the most recent refinement of the parihs framework [ ] . consistent with other reviews of the use of theoretical frameworks in implementation science, we found that parihs was often not used as intended. further, it was not always clear why the particular framework was chosen. frequently, authors merely cite a framework without providing any further information about how the framework was used. the lack of clear guidance on how to operationalize frameworks might be one of the underlying reasons for this. lastly, to enable a critical review of frameworks and further build collective understanding of implementation, we urge authors to be more explicit about how theory informs studies. development and adoption of reporting guidelines on how framework(s) are used in implementation studies might assist in sharpening the link between the used framework(s) and the individual study, but could potentially also enhance the opportunities for advancing the scientific understanding of implementation. to increase study reliability during the review process, more than one person identified, assessed, and interpreted the data. we had regular meetings to discuss potential difficulties in assessing included articles, and subsequently, all decisions were resolved by consensus to enhance rigor. we used a rigorous search strategy, which was undertaken by an information specialist. the standardization of our processes across the team was also enhanced by the creation of an online data extraction form via google. however, as the form was not linked to other software (e.g., endnote), this added timeconsuming processes. as we did not include articles that were not written in english, we may have limited the insights about the application of the parihs framework, particularly with relevance to different country contexts. additionally, we did not search the grey literature for practical reasons concerning the size of the literature, which may also have provided some additional insights not reflected in this publication. we also limited our search to two databases, which may mean we missed some relevant articles. however, we are confident that we found the majority of relevant published evidence to address the review questions because of a rigorous approach to retrieval. thus, we think the findings of our citation analysis on the use of parihs are generalizable for studies in english published in peer-reviewed journals. the importance of theoretically underpinned implementation science has been consistently highlighted. theory is important for maximizing the chances of study transferability, providing an explanation of implementation processes, developing and tailoring implementation interventions, evaluating implementation, and explaining outcomes. this review of the use of the parihs framework, one of the most cited implementation frameworks, shows that its actual use and application has been frequently partial and generally not well described. our ability to advance the science of implementation and ultimately affect outcomes will, in part, be dependent on better use of theory. therefore, it is incumbent on theory developers to generate accessible and applicable theories, frameworks, and models, and for theory users to operationalize these in a considered and transparent way. we propose that the development and adoption of reporting guidelines on how framework(s) are used in implementation studies might enhance the maturity of implementation science. supplementary information accompanies this paper at https://doi.org/ . /s - - - . additional file : form for initial assessment and form for data extraction assessing citation networks for dissemination and implementation research frameworks making sense of implementation theories, models and frameworks bridging research and practice: models for dissemination and implementation research criteria for selecting implementation science theories and frameworks: results from an international survey enabling the implementation of evidence based practice: a conceptual framework diffusion of innovations models and frameworks for implementing evidence-based practice: linking evidence to action ingredients for change: revisiting a conceptual framework an exploration of the factors that influence the implementation of evidence into practice implementing evidence-based practice in healthcare: a facilitation guide: routledge using the knowledge to action framework in practice: a citation analysis and systematic review a systematic review of the use of the consolidated framework for implementation research a critical synthesis of literature on the promoting action on research implementation in health services (parihs) framework preferred reporting items for systematic reviews and meta-analyses: the prisma statement real qualitative researchers do not count: the use of numbers in qualitative research methodological challenges in qualitative content analysis: a discussion paper the qualitative content analysis process evaluating the successful implementation of evidence into practice using the parihs framework: theoretical and practical challenges getting evidence into practice: the role and function of facilitation the parihs framework--a framework for guiding the implementation of evidence-based practice what counts as evidence in evidence-based practice? getting evidence into practice: the meaning of 'context' provision of peer specialist services in va patient aligned care teams: protocol for testing a cluster randomized implementation trial a complex culturally targeted intervention to reduce hispanic disparities in living kidney donor transplantation: an effectiveness-implementation hybrid study protocol implementing a knowledge application program for anxiety and depression in community-based primary mental health care: a multiple case study research protocol implementation of a knowledge mobilization model to prevent peripheral venous catheter-related adverse events: prebacp study-a multicenter cluster-randomized trial protocol prioritising responses of nurses to deteriorating patient observations (pronto) protocol: testing the effectiveness of a facilitation intervention in a pragmatic, cluster-randomised trial with an embedded process evaluation and cost analysis case management and self-management support for frequent users with chronic disease in primary care: a pragmatic randomized controlled trial brief cognitive behavioral therapy in primary care: a hybrid type patient-randomized effectiveness-implementation design scaling up safer birth bundle through quality improvement in nepal (sustain)-a stepped wedge cluster randomized controlled trial in public hospitals monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation a study protocol for applying the co-creating knowledge translation framework to a population health study accessibility and implementation in uk services of an effective depression relapse prevention programme -mindfulness-based cognitive therapy (mbct): aspire study protocol study protocol for the translating research in elder care (trec): building context through case studies in long-term care project (project two) implementing health research through academic and clinical partnerships: a realistic evaluation of the collaborations for leadership in applied health research and care (clahrc) protocol: adaptive implementation of effective programs trial (adept): cluster randomized smart trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program an inpatient rehabilitation model of care targeting patients with cognitive impairment development of a management algorithm for post-operative pain (mapp) after total knee and total hip replacement: study rationale and design improving quality and outcomes of stroke care in hospitals: protocol and statistical analysis plan for the stroke implementation study comparison of high and low intensity contact between secondary and primary care to detect people at ultra-high risk for psychosis: study protocol for a theorybased, cluster randomized controlled trial implementing the i-decided clinical decision-making tool for peripheral intravenous catheter assessment and safe removal: protocol for an interrupted timeseries study translating health care-associated urinary tract infection prevention research into practice via the bladder bundle evidence-based intervention to reduce avoidable hospital admissions in care home residents (the better health in residents in care homes (bhirch) study): protocol for a pilot cluster randomised trial fire (facilitating implementation of research evidence): a study protocol developing family-centred care in a neonatal intensive care unit: an action research study protocol implementing knowledge into practice for improved neonatal survival; a cluster-randomised, community-based trial in quang ninh province knowledgeto-action processes in shrtn collaborative communities of practice: a study protocol study protocol for the translating research in elder care (trec): building contextan organizational monitoring program in long-term care project (project one) the prevention and reduction of weight loss in an acute tertiary care setting: protocol for a pragmatic stepped wedge randomised cluster trial (the prowl project) evidence into practice: evaluating a child-centred intervention for diabetes medicine management. the epic project adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study study protocol: addressing evidence and context to facilitate transfer and uptake of consultation recording use in oncology: a knowledge translation implementation study improving quality of care through routine, successful implementation of evidencebased practice at the bedside: an organizational case study protocol using the pettigrew and whipp model of strategic change exploring the interpersonal-, organization-, and system-level factors that influence the implementation and use of an innovation-synoptic reporting-in cancer care labouring together: collaborative alliances in maternity care in victoria, australia-protocol of a mixed-methods study determining factors in evidencebased clinical practice among hospital and primary care nursing staff sustaining transfers through affordable research translation (start): study protocol to assess knowledge translation interventions in continuing care settings process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to improve neonatal survival in the quang ninh province newborn care and knowledge translation -perceptions among primary healthcare staff in northern vietnam urban and suburban hospital system implementation of multipoint access targeted temperature management in postcardiac arrest patients. therapeutic hypothermia and temperature management south west community care access centre home care c. evolving the theory and praxis of knowledge translation through social interaction: a social phenomenological study implementation of evidence-based practice for a pediatric pain assessment instrument improving hospital environmental hygiene with the use of a targeted multi-modal bundle strategy to assess prerequisites before an implementation strategy in an orthopaedic department in sweden improving care for people after stroke: how change was actively facilitated implementation of a suicide nomenclature within two va healthcare settings exploring psychological safety as a component of facilitation within the promoting action on research implementation in health services framework facilitating successful implementation of a person-centred intervention to support family carers within palliative care: a qualitative study of the carer support needs assessment tool (csna t) intervention the influence of context and practitioner attitudes on implementation of person-centered assessment and support for family carers within palliative care why is it so hard to implement change? a qualitative examination of barriers and facilitators to distribution of naloxone for overdose prevention in a safety net environment from workshop to work practice: an exploration of context and facilitation in the development of evidencebased practice enhancing the quality of oral nutrition support for hospitalized patients: a mixed methods knowledge translation study (the eqons study) evaluations of implementation at early-adopting lung cancer screening programs: lessons learned changing practice to support self-management and recovery in mental illness: application of an implementation model designing and implementing two facilitation interventions within the 'facilitating implementation of research evidence (fire)' study: a qualitative analysis from an external facilitators' perspective a randomized controlled study of practice facilitation to improve the provision of medication management services in alberta community pharmacies improving patient participation in a challenging context: a -year evaluation study of an implementation project improving oral health for older people in the home care setting: an exploratory implementation study implementation of video telehealth to improve access to evidence-based psychotherapy for posttraumatic stress disorder the inter-play between facilitation and context in the promoting action on research implementation in health services framework: a qualitative exploratory implementation study embedded in a cluster randomized controlled trial to reduce restraint in nursing homes blending critical realist and emancipatory practice development 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implementation of a new zealand-wide guideline for assessment and management of cardiovascular risk in primary health care: a template analysis use of research by undergraduate nursing students: a qualitative descriptive study building a primary care/research partnership: lessons learned from a telehealth intervention for diabetes and depression handling a challenging context: experiences of facilitating evidence-based elderly care building capacity for evidence informed decision making in public health: a case study of organizational change examination of the utility of the promoting action on research implementation in health services framework for implementation of evidence based practice in residential aged care settings perceptions of national guidelines and their (non) implementation in mental healthcare: a deductive and inductive content analysis a qualitative study to identify barriers and facilitators to implementation of pilot interventions in the veterans health administration (vha) northwest network role of "external facilitation" in implementation of research findings: a qualitative evaluation of facilitation experiences in the veterans health administration the influence of context on pain practices in the nicu: perceptions of health care professionals associations between perceptions of evidence and adoption of h n influenza infection prevention strategies among healthcare workers providing care to persons with spinal cord injury use of implementation theory: a focus on parihs participants' perceptions of an intervention implemented in an action research nursing documentation project development and validation of a derived measure of research utilization by nurses promoting action on research implementation in health services framework applied to teamstepps implementation in small rural hospitals. health care manage rev mindfulness training in uk secondary schools: a multiple case study approach to identification of cornerstones of implementation evidence molded by contact with staff culture and patient milieu: an analysis of the social process of knowledge utilization in nursing homes barriers and facilitators to implementing the baby-friendly hospital initiative in neonatal intensive care units skills and attributes required by clinical nurse specialists to promote evidence-based practice perceptions of speech-language pathologists linked to evidence-based practice use in skilled nursing facilities nurse managers' prerequisite for nursing development: a survey on pressure ulcers and contextual factors in hospital organizations the relationship between baseline organizational readiness to change assessment subscale scores and implementation of hepatitis prevention services in substance use disorders treatment clinics: a case study a formative evaluation of organizational readiness to implement nurseinitiated hiv rapid testing in two veterans health administration substance use disorder clinics promoting evidence-based urinary incontinence management in acute nursing and rehabilitation care-a process evaluation of an implementation intervention in the orthopaedic context a mixed method study of an education intervention to reduce use of restraint and implement person-centered dementia care in nursing homes the nurse as bricoleur in falls prevention: learning from a case study of the implementation of fall prevention best practices deimplementing inhaled corticosteroids to improve care and safety in copd treatment: primary care providers' perspectives the role of evidence and context for implementing a multimodal intervention to increase hiv testing automating quality measures for heart failure using natural language processing: a descriptive study in the department of veterans affairs implementing an inpatient acupuncture service for pain and symptom management: identifying opportunities and challenges survey of primary care and mental health prescribers' perspectives on reducing opioid and benzodiazepine co-prescribing among veterans factor structure, reliability and measurement invariance of the alberta context tool and the conceptual research utilization scale, for german residential long term care implementing immediate postpartum long-acting reversible contraception programs successful factors to prevent pressure ulcers -an interview study communities of practice for supporting health systems change: a missed opportunity aspects affecting occupational therapists' reasoning when implementing research-based evidence in stroke rehabilitation forming and activating an internal facilitation group for successful implementation: a qualitative study ready to deliver maternal and newborn care? health providers' perceptions of their work context in rural mozambique identifying and addressing language needs in primary care: a pilot implementation study a realistic evaluation: the case of protocol-based care patientprovider secure messaging in va: variations in adoption and association with urgent care utilization flying by the seat of our pants": current processes to share best practices to deal with elder abuse readiness for implementation of lung cancer screening. a national survey of veterans affairs pulmonologists implementing and sustaining evidence-based practice in health care: the bridge model experience staff perceptions of substance use disorder treatment in va primary care-mental health integrated clinics a comparison of research utilization among nurses working in canadian civilian and united states army healthcare settings the real world journey of implementing fall prevention best practices in three acute care hospitals: a case study facilitation of research-based evidence within occupational therapy in stroke rehabilitation implementation of evidence-based practices in the context of a redevelopment project in a canadian healthcare organization advancing the use of theory in occupational therapy: a collaborative process supporting the uptake of nursing guidelines: what you really need to know to move nursing guidelines into practice factors influencing the provision of end-of-life care in critical care settings: development and testing of a survey instrument the influence of organizational context on the use of research by nurses in canadian pediatric hospitals development and implementation of a standardized care plan for carotid endarterectomy a qualitative study of a primary-care based intervention to improve the management of patients with heart failure: the dynamic relationship between facilitation and context multi-level factors influence the implementation and use of complex innovations in cancer care: a multiple case study of synoptic reporting synthesizing research evidence for therapists providing homebased rehabilitative care what is the evidence and context for implementing family-centered care for older adults? physical & occupational therapy in geriatrics empowering nurses with evidence-based practice environments: surveying magnet(r), pathway to excellence(r), and non-magnet facilities in one healthcare system pay-forperformance policy and data-driven decision making within nursing homes: a qualitative study implementation of a multimodal patient safety improvement program "safetyleap" in intensive care units health promotion practice and its implementation in swedish health care developing the practice context to enable more effective pain management with older people: an action research approach applying the re-aim framework to evaluate two implementation strategies used to introduce a tool for lifestyle intervention in swedish primary health care experiences of working with the tobacco issue in the context of health promoting hospitals and health services: a qualitative study insights into the impact and use of research results in a residential long-term care facility: a case study turning knowledge into action at the point-of-care: the collective experience of nurses facilitating the implementation of evidence-based practice experience of adapting and implementing an evidence-based nursing guideline for prevention of diaper dermatitis in a paediatric oncology setting promoting continence in nursing homes in four european countries: the use of paces as a mechanism for improving the uptake of evidence-based recommendations the operation of a research and development (r&d) program and its significance for practice change in community pharmacy one-on-one coaching to improve pain assessment and management practices of pediatric nurses development and implementation of the steps to successful palliative care programme in residential care homes for people with a learning disability improving the approach to future care planning in care homes the experiences of professionals regarding involvement of parents in neonatal pain management understanding the role of communities of practice in evidence-informed decision making in public health how to introduce medical ethics at the bedside -factors influencing the implementation of an ethical decision-making model hospital readiness for undertaking evidence-based practice: a survey physical function and physical activity assessment and promotion in the hemodialysis clinic: a qualitative study perceptions of practice guidelines for people with spinal cord injury using implementation science to facilitate evidence-based practice changes to promote optimal outcomes for orthopaedic patients a context of uncertainty: how context shapes nurses' research utilization behaviors developing familycentred care in a neonatal intensive care unit: an action research study attributes of context relevant to healthcare professionals' use of research evidence in clinical practice: a multi-study analysis health care professionals' attitudes and compliance to clinical practice guidelines to prevent falls and fall injuries implementation of pictorial support for communication with people who have been forced to flee: experiences from neonatal care using undergraduate nursing students as mediators in a knowledge transfer programme for care for patients with advanced cancer pressure-relieving equipment: promoting its correct use amongst nurses via differing modes of educational delivery comprehensive assessment of chronic pain management in primary care: a first phase of a quality improvement initiative at a multisite community health center nuno-solinis r. a qualitative study on clinicians' perceptions about the implementation of a population risk stratification tool in primary care practice of the basque health service health system context and implementation of evidence-based practices-development and validation of the context assessment for community health (coach) tool for low-and middle-income settings engaging and developing front-line clinical nurses to drive care excellence: evaluating the chief nurse excellence in care junior fellowship initiative outcomes of a clinical nurse specialist-initiated wound care education program: using the promoting action on research implementation in health services framework enacting change through action learning: mobilizing and managing power and emotion training substance use disorder counselors in cognitive behavioral therapy for depression: development and initial exploration of an online training program implementation and evaluation of the va dpp clinical demonstration: protocol for a multi-site non-randomized hybrid effectivenessimplementation type iii trial supporting evidence-based practice for nurses through information technologies exploring perceptions of a learning organization by rns and relationship to ebp beliefs and implementation in the acute care setting translational networks in healthcare? evidence on the design and initiation of organizational networks for knowledge mobilization children's pain assessment in northeastern thailand: perspectives of health professionals collaboration processes, outcomes, challenges and enablers of distributed clinical communities of practice coronary stents and subsequent surgery: reported provider attitudes and practice patterns increasing adherence to scheduled outpatient dobutamine stress echocardiograms technical assistance as a prevention capacity-building tool: a demonstration using the getting to outcomes framework staff, space, and time as dimensions of organizational slack: a psychometric assessment swedish translation, adaptation and psychometric evaluation of the context assessment index (cai) a model of regulatory alignment to enhance the long-term care survey process in a veterans health care network ranking and prioritizing strategies for reducing mortality and morbidity from noncommunicable diseases post disaster: an australian perspective development and testing of the nurse manager ebp competency scale unit leadership and climates for evidence-based practice implementation in acute care: a crosssectional descriptive study towards the transformation of practice in early childhood education: the effective provision of pre-school education (eppe) project reliability and validity of the alberta context tool (act) with professional nurses: findings from a multi-study analysis evidence-based practice self-efficacy scale preliminary reliability and validity health system-level factors influence the implementation of complex innovations in cancer care the influence of clinical decision support on diagnostic accuracy in nurse practitioners interventions to increase influenza vaccination rates in veterans with spinal cord injuries and disorders the use of decision support systems in social work: a scoping study literature review developing postoperative pain management: utilising the promoting action on research implementation in health services (parihs) framework the effectiveness of implementation in indigenous australian healthcare: an overview of literature reviews assessing the relationships between contextual factors and research utilization in nursing: systematic literature review research utilization and clinical nurse educators: a systematic review making sense of complexity in context and implementation: the context and implementation of complex interventions (cici) framework the development and theoretical application of an implementation framework for dialectical behaviour therapy: a critical literature review confronting challenges in reducing heart failure -day readmissions: lessons learned with implications for evidence-based practice implementation strategies for collaborative primary care-mental health models the contribution of conceptual frameworks to knowledge translation interventions in physical therapy facilitation as a role and process in achieving evidence-based practice in nursing: a focused review of concept and meaning a checklist for identifying determinants of practice: a systematic review and synthesis of frameworks and taxonomies of 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remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors wish to acknowledge sayna bahraini, heledd owen griffiths, and veronica costea for partaking in the initial assessment of retrieved articles. all authors made substantial contributions to the manuscript. kg and ab conducted the citation searches. ab led the initial assessment. ab, ae, ace, idg, gh, ak, jrm, and lw developed the data extraction form and undertook data extraction in pairs of two. ab coordinated the data extraction. ab analyzed the descriptive data and ae, ace, gh, sh, ak, and lw analyzed the qualitative data. ab prepared figures and tables and drafted the manuscript together with lw, ae, ace, idg, kg, gh, sh, ak, and jrm revised the manuscript. all authors have read and gave final approval of the version of the manuscript submitted for publication. idg is a recipient of a cihr foundation grant (fdn # ) and ab the recipient of a forte grant (cofas- , - ) . the funders had no role in designing the study, retrieving, or analyzing included articles, decision to publish, or preparation of the manuscript. open access funding provided by uppsala university. the datasets generated and analyzed during the current study can be obtained through contacting the first author.ethics approval and consent to participate not applicable. not applicable. we acknowledge that gh, ak, and jrm were all involved in the development of the parihs framework. further, idg, jrm, and lw are all members of the bmc implementation science editorial board. key: cord- - fcac aw authors: srisai, patinya; phaiyarom, mathudara; suphanchaimat, rapeepong title: perspectives of migrants and employers on the national insurance policy (health insurance card scheme) for migrants: a case study in ranong, thailand date: - - journal: risk manag healthc policy doi: . /rmhp.s sha: doc_id: cord_uid: fcac aw background and purposes: thailand has implemented a nationwide insurance policy for migrants, namely the health insurance card scheme (hics), for a long time. however, numerous implementation challenges remain and migrant perspectives on the policy are rarely known. the aim of this study was to examine migrant service users’ perspectives and their consequent response towards the hics. methods: a qualitative case-study approach was employed. in-depth interviews with ten local migrants and four employers were conducted in one of the most densely migrant-populated provinces in thailand. document review was used as a means for data triangulation. inductive thematic analysis was exercised on interview data. results: the findings revealed that most migrants were not aware of the benefit, they are entitled to receive from the hics due to unclear communication and inadequate announcements about the policy. the registration costs needed for legalising migrants’ precarious status were a major concern. adequate support from employers was a key determining factor that encouraged migrants to participate in the registration process and purchase the insurance card. some employers sought assistance from private intermediaries or brokers to facilitate the registration process for migrants. conclusion: proper communication and promotion regarding the benefits of the hics and local authorities taking action to expedite the registration process for migrants are recommended. the policy should also establish a mechanism to receive feedback from migrants. this will help resolve implementation challenges and lead to further improvement of the policy. migrant health has become a major global policy discourse due to a high health burden, especially infectious diseases-related mortality in a large number of migrants. it is believed that nearly million people or . % of the global population resides outside their own country of origin. this number is predicted to increase and exceed million people in next three decades. it is due to the rapid growth of human mobility which has several contributing factors, such as economic opportunity, convenient transportation, political conflict, violence, and human trafficking. the issue of migrant health protection has been considered globally at many high-level meetings, such as the united nations general assembly meeting in , the world health assembly (wha) with resolutions wha . , wha . , and wha . , and the global compact for safe, orderly and regular migration adopted by member states of the united nations in . [ ] [ ] [ ] [ ] [ ] in , migrant health received increased global attention when the sustainable development goals (sdgs) included migrant health as fundamental in achieving universal health coverage (uhc) under the principle of "leave no one behind" the pathway to achieve such a goal requires huge effort from all sectors including immigration control, the security sector, labour authorities, and the public health arena as well as the implementation of migration laws and citizenship regulations in each individual country. thailand is a major migration hub as its location is suitable as a centre of transition and destination among countries in southeast asia. due to the country's rapid economic growth, it receives a huge number of migrants from neighbouring populations especially cambodia, lao pdr, myanmar, and vietnam (clmv nations). in , the cumulative volume of non-thai people in thailand was about . million. among these, . million were clmv migrant workers and dependants. over half of them entered the country without valid travel documents, and are recognised as undocumented migrants. a recent report by the international labour organization suggested that migrants contributed about . - . % of thai gross domestic product in . this situation, among other aspects, leads the thai government to exercise lenient measures to legalize and register these undocumented migrants rather than a deportation policy. one key measure is nationality verification (nv). with nv, undocumented migrants are able to reside and work in the country lawfully. the nv policy is implemented alongside a measure to protect the health of migrants. the most distinct health policy for migrants is the "health insurance card scheme" (hics), a national insurance scheme for clmv migrants managed by the ministry of public health (moph). the hics benefit package is comprehensive, covering all types of care including health promotion and disease prevention activities. the hics is financed by an annual premium. the hics revenues are pooled at the central moph and later redistributed in a decentralized manner to the local health facilities. an insuree does not need to pay for any cost upfront, except a us$ administrative fee. the card price gradually increased over a period of years from baht (us$ ) between and to baht (us$ ) in . this was because in the moph expanded the hics benefit to include hiv/aids treatment and certain high-cost treatments. migrants who enter the country lawfully and work in the formal sector (like firms, factories or enterprises) need not buy the hics as they are covered by the social security scheme (sss), which is the same social insurance for thai formal workers. the sss is financed by tri-partite contributions, equally shared between employer and employee ( % of the employee's salary and % subsidies of employer) as well as . % from the government. the sss is managed by the ministry of labour (mol). the benefit packages of the hics are quite similar to the sss. one of the most remarkable differences between the two schemes is that the sss provides additional non-health benefits for its beneficiaries (such as a pension and unemployment allowance). in mid- , after the military coup in thailand, the military government launched a "one stop service" (oss) policy to facilitate the registration of undocumented migrants and to expedite the nv process. the policy message at that time was quite strong that those failing to register with the oss would be deported. at the same time, the hics premium was reduced in order to attract more migrants to enrol in the scheme. from , the moph reduced the hics premium to baht (us$ ) for a migrant adult, plus baht (us$ ) for a health check-up before being enrolled in the scheme, and baht (us$ ) for a migrant child aged less than seven years. , despite these numerous proactive measures, evidence suggests that implementation gaps remain as a result of inadequate communication between related authorities particularly the ministry of interior, the minister of labour, and the minister of public health, and unclear policy implementation guidelines. for example, whether migrant employees or thai employers are responsible for the hics payment, and if migrants failing to register with the oss are still able to buy the hics. although policy implementation challenges from providers' perspectives were mentioned in some literature, little is known about the perceptions and practices of migrant service users and their employers. though it was previously discovered that hics contributed to increased service utilization among migrants, the rate of service utilization was still lower than the main insurance scheme of thai citizens (universal coverage scheme). as the ultimate goal of universal health coverage is to "leave no one behind" and to assure that everyone receives quality healthcare without incurring excessive healthcare spending, it is necessary to submit your manuscript | www.dovepress.com risk management and healthcare policy : explore the possible challenges of using the hics from both migrants' and employers' perspectives. therefore, this study aimed to examine the migrants' and employers' perspectives and their responses to the hics as part of the oss. it is hoped that findings from this study will not only extend the value and academic richness of public health research on migrant health in thailand, but also help inform policy makers in other countries, especially lower-and middle-income nations, to further improve migrant health policy implementation. moreover, this study may contribute to a better understanding of the hics and lead to the improvement of the hics on the ground. policy makers and frontline implementers may use these findings to tailor health services for migrants by making the insurance scheme more responsive to the health behaviour and perspectives of migrants. a qualitative case-study approach was employed. ranong, a province in the southern region of thailand, was selected as a study site. this is because it is an area with the highest ratio of insured migrants to thai citizens ( figure ). within the province, the research team focused on two districts with the highest number of migrants namely mueang and kraburi districts. mueang is the headquarter district of the province. it is geographically located next to victoria point, one of the major business cities of south myanmar. common occupations for migrants in mueang district lie within fishing industries, construction, and the service sector. by contrast, kraburi is more rural and most migrants are involved in the agricultural sector (rubber farming and rice planting). in order to examine the degree to which the migrant health policy is fulfilling migrant health needs, ten households with at least one member in the family with severe or chronic disease were purposively recruited. the family members' insurance status and household characteristics were taken into consideration to assure a good mix of migrants' background. since some migrants were in precarious legal status, the researchers faced many challenges in identifying them. thus, the researchers started identifying potential interviewees by discussing with local healthcare officers at the health centres and local nongovernment organizations (ngos) and asked them to facilitate the research team's entry into the field. additionally, the research team conducted the interviews with the employers of these migrants (n= ) in order to seek a comprehensive view from both migrants and their (thai) employers. the selection of employers was done through purposive sampling method, taking a variety of work characteristics into account. table demonstrates the characteristics dovepress of the ten selected migrants and four employers who agreed to participate in this study. data collection was performed by in-depth interviews with ten local migrants and four employers during october to september , the period right after the implementation of the oss. each informant was interviewed for about two to three rounds until the data were saturated. the first interview started with an informal discussion to enhance rapport. the following interviews then went into more depth and followed emerging discussion points. the interviews were conducted in either thai or myanmar or any preferred language of the informants. in order to mitigate a sense of coercion (unintentionally originated by the research team), the interview group was kept as small as possible (normally only the main interviewer and a note taker). each interview lasted about - minutes and took place at the interviewees' household. telephone interview was used instead for some interviewees who were uncomfortable to undergo a face-to-face interview. it is also important to note that some interviews preferred to participate in a group interview rather than an individual interview because some informants reported that they felt more secure to have their family members around while being interviewed. verbal consent from interviewees was requested before audio recording. all interviews were transcribed verbatim. tone of voice and laughter were all noted. the following additional procedures were included in order to safeguard the reliability of the translation. professional interpreters were asked to verify the correctness of the translation between audio records and transcripts. for the question guides, key informants were asked to describe their experiences of obtaining health-care services as well as their perception and relationship with hics and other policies concerned with migrant health. the question sets built upon a notion that the health-seeking behaviour of migrants and perceptions of the policy is vastly affected by factors such as the cost of services, and support from peers and family members. this does not necessarily align with the policy's initial objectives. the study's framework recognized two stages of policy including policy formulation and policy implementation phases; but for this study, the latter phase is the main focus. the agenda setting phase during policy formulation was explained in kingdon's model that when the agenda is set, the objectives of the policy are then translated to the policy implementation stage. in this phase, the street-level bureaucracy theory of lipsky elucidates that policy adaptation is inevitable at all levels of implementation. the adjustment is made to suit the policy users' circumstances which can unintentionally twist the original policy intention. additionally, health seeking behaviour among service users also plays a critical role in determining whether the health insurance policy has reached its ultimate goal. health seeking behaviour determinants as adapted from maxwell et al include three themes: namely (i) individual factors such as current health status and demographic profiles; (ii) system factors which refer to the existing health-care system and health policy; and (iii) societal factors referring to the physical and social environment and support. all mentioned theories were captured and modified in the conceptual framework ( figure ). data were imported into the nvivo v and coded manually. inductive thematic analysis was applied. the researcher performed data cleansing of the transcripts using audio records. condensed meaning units were then labelled by grouping paragraphs and sentences with the same content. similar meaning units were given preliminary codes and then alike codes were assembled to identify emerging categories. lastly, the researcher highlighted a higher construct/theme that was demonstrated throughout all categories. the interview data were triangulated with the document review, field notes and memos. since international health policy program (ihpp) is a smallsized organization, the commitments do not cover ethical consideration to avoid any possible conflict of interest. thus, the process for obtaining ethical approval requires an external institution with a high credibility. the institute for development of human research protection in thailand is a recognized institution that aims to protect rights, dignity, safety and well-being of participants in a research which is complied with international standards including declaration of helsinki, who gcp guidelines and so on. this study received ethics approval from the institute for development of human research protection in thailand (ihrp letter head: / ) which is complied with the declaration of helsinki. all data remained anonymous including transcripts, data entry and publications. the research team assured total confidentiality of the data to interviewees and advised that it is understandable and acceptable to withdraw from the study at any time or decline to answer any questions. verbal consent including consent to quote the participants was received instead of the gold standard of written consent since the written consent might cause migrants (particularly those with precarious legal status) to feel distress. all verbal consents were informed verbal consents and approved by the institute for development of human research protection a total of five themes emerged from the interviews with ten migrant service users and four employers. the headings of each theme were: (i) individual factor: different recognition of the insurance card's function; (ii) individual factor: equivocality of employment status; (iii) societal factor: support of family members, employers and peers; (iv) system factor: impression of the insurance card and related-health policies; (v) system factor: struggles in managing the insurance for migrant employees. note that, when mapping the above conceptual framework, some themes were classified as individual factors, while some were classified as either societal factors or system factors. details of all five themes were as follows. of the ten migrants being interviewed, seven were insured with the hics. there were various reasons for acquiring the insurance card. one interviewee (mm ), who was a translator at the health facility, informed that she recognized the benefit of the card and she strived to buy the card every year. two interviewees (mk and mk ) informed that they received the health card through the assistance of intermediaries (brokers), who helped them during the registration as part of the "registration package". one interviewee (mm ) stated that the health card could save her from being deported by the officials. she also joined the oss with a belief that the military might arrest her if she was uninsured. two interviewees (mm and mm ) misunderstood that traffic accidents were not covered by the health card despite the fact that they are actually covered. two out of seven insured interviewees obtained the card after they were sick (mm and mm ). the oss was designed to support all unregistered migrants within the country by providing them with the nv and issuing a work permit for migrant workers who had solid employer. however, some migrant workers in the province were involved with the informal sector and some were even self-employed. thus, the employment status of a migrant was often unclear, and their job description was not always straightforward or in line with the information provided during the registration. mm was a -year-old unlawful immigrant who had been through the oss registration and lived in thailand for more than years. while being a shop owner was not listed as legally permitted work for him and his work permit stated that he was a labourer, he worked as a karaoke shop owner in mueang district. technically, the shop was under the thai employer's name who charged him a monthly rent of us$ and allowed him to run the shop on behalf of the real owner. another complicated scenario was demonstrated through mm 's story who was a -year-old migrant and had been living in thailand for more than years. she did not possess a legitimate residence permit (tor ror / ). her hometown was in myanmar. she travelled into ranong by boat and every time she came she acquired a "border pass" ( figure ) from the sea border control. the border pass was an authorized travelling document between border towns with a permission of stay for not more than two weeks. it served as a relaxed border control between two adjacent countries and was issued for tourists or local people only for short business purposes. however, in reality, the interviewee (mm ) stayed in thailand almost all the time. she always renewed her border pass by crossing back to myanmar and getting it stamped by border control every two weeks. she earned a living by selling goods to her neighbours. in her opinion, the health card was pricey since she was still healthy and had no need for health-care services. she also considered the process cumbersome since a broker would need to help her acquire a passport and work permit before she could obtain the health card. the last example of an intricate employment status case was a mismatch between a work permit document and actual work status. one interviewee (mm ) had already possessed all necessary documents (a work permit, health card and residence permit). all documents were obtained with the assistance of a broker. however, the name of employer listed in her work permit was not the real employer who hired her to peel shrimps on a daily basis. it was noticeable that migrants living in kraburi could earn a greater amount of income, had bigger houses and received better support from family members and peers compared with migrants living in mueang. the nv had already been achieved in three out of four migrant interviewees in kraburi (mk , mk , and mk ). additionally, all of these three remained in contact with their family and cousins in myanmar. in contrast, most interviewees from mueang did not keep in touch with their relatives. an explanation (stated by the interviewees) was that migrants in kraburi could easily and economically cross a river back to myanmar (around us$ per head per trip by an unofficial local speedboat). thus, they travelled back and forth for numerous significant family events. one interviewee (mk ) stated that her employer, a rubber field owner, provided accommodation for her free of charge (except electricity bills). she was not residing with her husband and her one-month-old baby. her baby was taken care of with support from her cousin who crossed a river from myanmar to help her almost every day. support from employers was also distinct in kraburi district as most rubber owners offered not only higher salaries than in other districts, but also assistance for oss registration. all insured interviewees expressed that they were pleased with the health services and decent care from a hospital. two interviewees (mm and mm ) also stated that the frontline workers and nurses were less friendly than most doctors they had encountered. since the doctors at a hospital were always available, the migrants interviewed preferred to go to a hospital rather than a health centre where the services were mostly provided by nurses. they were all impressed with how the hics could save them healthcare costs substantially. however, their health-seeking behaviour was affected by a waiting time especially among uninsured migrants with minor diseases. thus, most of them chose to visit a private clinic as a first solution when becoming ill. one interviewee (mk ) explained that she was willing to pay an extra cost at a private clinic (about us$ per visit) to reduce her waiting time for treatment. as a hics insuree, she commented that it would be better if the card could cover all of her family members. it is also important to note that her background was unique. she had risk management and healthcare policy : submit your manuscript | www.dovepress.com dovepress been unofficially married to a thai man for over ten years and she was registered as the housemaid of her husband in her work permit. she had not obtained thai nationality yet and this was the reason she bought the hics instead. though all interviewees expressed that the card could significantly reduce their health expenditure, most of them were still doubtful about the benefit of the card and the reasons behind the change of the card price and related regulations over time. all information about the card was received from discussions with neighbours and peers rather than official announcements. the advantage of the card is if we have surgery or if we are giving birth, we pay only a little (uss ) . . . but the policy changed very quickly. we even informed the villagers (about the card), and then the policy changed again, and the villagers came to blame us (for giving wrong information). [mm ] mk also shared her views that most of her migrant peers preferred the hics to the sss. a migrant could (and should) switch his/her insured status from the hics to the sss when their nv process is completed and/or when he/she changed jobs from the informal to the formal sector. however, in reality, very few migrants and employers wished to change their insurance schemes. they stated that it was because the monthly payment for sss was much greater than the hics premium despite the fact that the sss provided additional benefits to healthcare treatment. additionally, they also expressed that the reimbursement process was complicated and not suitable for their needs. the social security office (the governing body of the sss) told that they will give us the money back when we reach years of age, and also when we die. who will guarantee that we will receive that money? and they say they will give us baht (us$ ) when we leave for our homeland. but you must send notice (to the social security office) in advance . . . who will know that their cousin will die by next month? just baht! i can collect it by myself. [mm ] all the four employers (rn_e , rn_e , rn_e , and rn_b ) expressed their unfavourable attitude toward hics that it should not be a compulsory policy since it was impractical to purchase their migrant employees a service that they could rarely use as their routine jobs was mobile. specifically, when migrant workers were working with fishery company where they were mostly offshore. additionally, they mentioned how legalisation of migrant workers could potentially cause them to lose their employees. when migrant workers passed the nv process, they were allowed to move outside their registered area, and this meant that the employers might lose the employees after the registration process was completed. thus, paying for the insurance and going through all the registration processes when their employees could leave anytime was not a preferred choice for the employers. i am always against the hics. i will be ok with it if it is for migrant who works on land and fish docks. i think those seasiders do not have an opportunity to enjoy the service since they are always in other countries. i spent over a million for this insurance while some migrants only worked for me for some time and then they left. i did not even have a chance to collect the fees from them. i think the policy makers did not understand this context . . . [rn_e ] two employers (rn_b and rn_e ) also mentioned the red tape of the registration process which drive them to rely on brokers to attain the registration though extra charges incurred. nowadays, there emerge new jobs that try to assist employers in the registration process for migrants. though i had to pay more but it is less burdensome (laugh!). i got charged for baht per migrant but the registration required various steps and very tedious since there are many people . . ..that's why i am ok with paying for brokers. [rn_e ] overall, this study provides perspectives from and adaptive behaviour of myanmar beneficiaries towards the hics, the main insurance policy for cross-border migrants in thailand. based on the researchers' knowledge, this study is probably among the first of studies to comprehensively explore the perception and behaviour of migrants towards the hics (and related registration policies including the oss and the work permit issuance). although the hics is well recognized in many international platforms as one of a best practices for providing access to health for vulnerable populations, its actual implementation still faces several challenges. submit your manuscript | www.dovepress.com risk management and healthcare policy : one of the clear discoveries from this study is that not all migrants conform to the hics regulation or the oss registration policy. as presented above, some migrants did not recognise the existence of the hics and the majority of the interviewees had little knowledge about it. phaiyarom et al conducted research in two border hospitals in thailand, which are located in migrant-populated areas. the findings highlighted that service utilization of hics between and was significantly lower than usage of the universal coverage scheme (ucs), the main insurance scheme for thai citizens, for both inpatient (ip) and outpatient (op) visits. phaiyarom et al also suggested that the hics only increased overall op visit by . %, compared with uninsured migrants; but this effect size was still smaller than the ucs patients (+ . %) (see supplementary file). maxwell et al pointed that knowledge on the existing healthcare system was an important factor that determined the use of healthcare service (and for this research determines the likelihood of obtaining the insurance). it was also discovered that migrants in france underutilized health services due to an unawareness of their existence and a lack of familiarity with the health-care system. this research also identifies a more sophisticated point, which is that access to the insurance is not merely determined by an individual's knowledge or perception. it also depends on the design of the system. a clear instance of this is that most migrants (seven from ten interviewees) realized that the hics was part of the nv registration package and to obtain the hics, the most common practice is to rely on private intermediaries (or in their language, "brokers"). this preference also occurred among employers to overcome a strenuous effort to complete the registration for migrant employees. the interference of brokers causes the registration cost to soar tremendously. it was noted that some brokers engaged in all employment processes from faking desirable working conditions to producing counterfeit entry documents, and this led to a higher cost during registration processes than through the official route. the migrants' exploitation was an alarming issue, especially when migrants choose to receive brokers' services regardless of price and do not appreciate how their labour rights are actually better protected by official registration processes. this phenomenon clearly contradicts the primary objective of the policy that intends to enrol as many migrants as possible in the insurance. when the process of obtaining the insurance was not smooth, some migrants opted to leave themselves uninsured and willingly dropped out the system. in contrast, those who acknowledged the benefit of the hics always found a loophole in the system in order to access the insurance. for example, this study depicts the story of a woman (mm ) who did not possess a legitimate residence permit but somehow was able to access the insurance. the only proof of residence was the travel pass which she renewed from time to time. another example is a woman (mm ) who did not know the name of the employer listed on her work permit, but for some reason she was able to complete the whole registration process and acquire the work permit as well as the insurance card. in other words, the process for service users to acquire the insurance card is distorted from the initial policy intention. this policy adaptation occurs not only among migrants and employers, but also among service providers. suphanchaimat et al highlighted that local providers involved with the hics also adapted their routine practice in a way that matched their work burden and individual perception. for example, some providers decided not to sell the insurance card to migrants who were "seemingly" sick despite a lack of guidelines from the moph that ratifies such an action. some healthcare providers introduced this internal policy because they deemed that insuring "seemingly sick" migrants might create a financial risk to them (adverse selection phenomenon). however, some evidence shows that the hics has generated a positive balance for some health facilities, especially those in bangkok. these incidents are consistent with the street-level bureaucracy (slb) theory by lipsky, which suggests that policy modification can appear at all levels along the implementation line. erasmus elaborates more on this point, suggesting that the adaptation of policy is part of the coping mechanisms of the people involved in the policy. there were also a deadlock situation which is not merely confined to the slb, but is linked to a larger conceptual dilemma about whether migrants with chronic diseases are unable to appreciate the card benefits as equally as healthy migrants. although most of the interviewees who were insured agreed that hics insurance could save them health expenditure, some migrants with chronic conditions could not obtain the work permit as they were too weak to be re-hired by an employer. suphanchaimat et al dovepress uninsured migrants. it was also observed that uninsured migrants had to pay tremendously more than the hics insured migrants ( baht or us$ ) when they got severe conditions that required a hospital admission. in , when the hics included high-cost care in the benefit package, the oop among hics beneficiaries became even lower than the previous year and the gaps in the oop between insured and uninsured migrants became more remarkable as well. as a result, service utilization from hics in and soared higher to the point where it was even marginally higher than the ucs. this highlighted not only the hics's success, but also a policy gap that occurred when an unhealthy migrant could not obtain a work permit and thus, the care they needed. as highlighted in an earlier study, the government ties the health insurance (hics) with a work permit to promote both work rights and health protection at the same time. yet this mechanism comes with an unintended consequence in that it practically creates a dead-end circumstance for vulnerable migrants. leaving unhealthy migrants uninsured is more likely to bring about serious negative consequences than insuring them from the outset. the negative consequences are not just the impact on the balance sheet of a health facility but also the impact on health security for the whole of society, which might be particularly apparent during an outbreak. the world economic forum has recently expressed concern over the world's migrants who have no financial resources and supportive health insurance as this could be devastating if countries are unable to take precautionary measures with an entire population during a pandemic. stimpson et al also marked that it was necessary to protect public health from uncontrolled pandemics with a feasible option for unauthorized migrants to obtain health insurance that provides prevention and treatment of infectious diseases. in germany, health insurance for migrants is tied with work and residence status. this means undocumented migrants need to apply for a health card first before enjoying the right to health-care services. in germany a law of infectious disease allows undocumented migrants to obtain free screening and counseling for certain diseases without a requirement to disclose their identity and working status to health-care providers. in france, emergency care is freely offered to all migrants regardless of their immigration status for the first three months of their stay. in the meantime, the french government established a special fund to cover unpaid debts of health facilities caused by providing emergency care for uninsured migrants. the adaptive behaviours of migrants appear not only among migrant populations. suphanchaimat and napaumporn report that there was a laotian immigrant who undertook a registration more than five times and possessed five passports despite the fact that she only needed to complete the registration once. this sort of policy adaptive behaviour also appeared among users of other health policies. it is also interesting to explore further whether these challenges in policy implementation are reported back to the central authorities (particularly the moph) so it can fine-tune and improve the hics; and this point can serve as a recommended topic for further studies. the case stories above (indirectly) indicate the incoherence between ministries, especially the moph and the mol. it means that the data between both ministries are not synchronized. in theory, those obtaining a work permit should be insured for their health concurrently. in other words, it means that that health and labour protection does not go in tandem. in terms of policy implication, the hics design should be reviewed to capture all the dynamics of migrant policies and behaviour of migrants in thailand. hics registration (as well as the oss) should be simplified and free from unnecessary interference by private intermediaries in order to reduce financial barriers that hinder access to care and the nv process. in addition, this study points to a larger question of whether the thai government is ready and willing to take care of undocumented migrants who do not have equivocal employment status or who fail to take part in the nv process. if so, the hics alone might not be able to fully address this problem as it is still linked to the registration process, where in reality there will be always people who slip out of the system. in this respect, the thai government may consider introducing a parallel health service system which allows (unregistered) undocumented migrants to enjoy services. however, this proposal creates a circular logic concerning who will bear the cost of care, and innovative financing systems need to be considered and perhaps such measures go beyond the responsibility of a single country. all these recommendations should be seriously considered and all concerned parties (the government, migrants, employers and academics to name but a few) should be able to take part in the policy design from the outset. there remain some limitations in this study. firstly, the study site was only performed in one province, which is the main residential area for most myanmar migrants in thailand. although myanmar migrants constitute the largest share of all non-thai nationals, it is still questionable if the findings can be generalized to all migrants in other areas in thailand. however, the discovery shown in this study might be, to some extent, transferable to other countries with a relatively similar context to ranong. secondly, implications from the findings were made from the interview results rather than actual behaviour observed by the investigators. the interviewers attempted to triangulate the study validity by various means such as informal discussions with local providers or community leaders. thirdly, the small number of respondents could limit the ability of the study to capture all possible challenges in implementing the policy. it is likely that the investigators missed "the most vulnerable of the vulnerable" such as a totally undocumented migrant with chronic diseases living in faraway village that cannot be identified by the local health staff or ngos. lastly, this study focuses on the views and behaviours of the migrant service users only. to gain a better understanding on the hics in all dimensions, it is necessary to take a thorough view from all stakeholders' perspectives including policy makers, service providers, donors, civic group representatives and academics. therefore, the interpretation of the findings should be made with caution and if there are points to be considered for policy for recommendations, the views from other stakeholders should be seriously taken into consideration. health insurance for migrants allows them to enjoy their human right to access essential care regardless of ethnicity. the migrants' and employers' perspectives on and responses to the health insurance card scheme (hics) in this study reflect the challenges faced in policy implementation. due to the lack of familiarity with the policy, migrants were unaware of the benefit they could claim in obtaining the health card. this reflects how their rights were not clearly communicated and promoted. migrant exploitation is another alarming issue, and it is evident that brokers create opportunities during confusing registration process resulting in a costlier process than necessary. policy intention distortion and adaptation to suit actual situations and individual justifications appeared among both service providers and user's responses as part of the policy engagement mechanism. unhealthy migrants are possibly unable to benefit from the policy as much as healthy migrants due to the lack of alternative pathways for them to obtain the service economically. public health concerns over a control of infectious diseases among unauthorized migrants who have no access to health services are flagged as a threat that need to be resolved strategically. policy recommendations emerging from the findings can be summarised into four main points. firstly, the benefits of hics and official registration processes for migrants should be vividly and correctly communicated and promoted by local authorities to avoid both underuse of health insurance and broker interference. secondly, cumbersome and time-consuming registration processes could be resolved in order to close gaps for broker interference. thirdly, migrants with chronic conditions and unauthorized migrants should be taken into policy design considerations in order to protect public health. lastly, feedback channels from the ground to central levels are also indispensable in order to accumulate and resolve implementation dilemmas and this should be further examined. global patterns of mortality in international migrants: a systematic review and meta-analysis a/ ) united nations world migration report : the future of migration: building capacities for change. geneva: international organization for migration world health organization. th assembly. resolution wha . -workers' health: global plan of action. resolution 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protecting maternal and child health gdp per capita (current us$): the world bank national council for peace and order. temporary measures to problems of migrant workers and human trafficking (order no. / ) outcomes of the health insurance card scheme on migrants' use of health services in ranong province, thailand overview of migrant utilisation in ranong hospital. province svobohair, editor. ranong, thailand: ranong hospital marginalization, morbidity and mortality: a case study of myanmar migrants in ranong province agendas, alternatives, and public policies street-level bureaucracy: dilemmas of the individual in public services developing theoretically based and culturally appropriate interventions to promote hepatitis b testing in asian american populations the ministry of foreign affairs. the rd global compact for safe, orderly and regular migration stakeholder workshop good practice in health care for migrants: views and experiences of care professionals in european countries extreme exploitation in southeast asia waters: challenges in progressing towards universal health coverage for migrant workers financing healthcare for migrants: a case study from thailand. nonthaburi, thailand: health insurance system research office/ health systems research institute the use of street-level bureaucracy theory in health policy analysis in low-and middle-income countries: a meta-ethnographic synthesis the effects of the health insurance card scheme on out-of-pocket expenditure among migrants in ranong province, thailand. risk manag healthc policy covid- surge exposes ugly truth about singapore's treatment of migrant workers the coronavirus pandemic could be devastating for the world's migrants: world economic forum unauthorized immigrants spend less than other immigrants and us natives on health care health care for undocumented migrants: european approaches well-being development program for alien health populations in thailand (phase i). nonthaburi: hisro/ihpp/ the graphico systems co open access funding provided by the qatar national library. all authors would like to express great appreciation toward local workers, migrants' interviewees and ihpp members who accommodated the data collection process. there is also a high appreciation toward some data from the doctoral thesis of dr suphanchaimat. it is noted that the analysis and writing style was not uniquely the same as presented in the thesis. for instance, some more references that were not contained in the thesis were included. enlightening guidance and advice from lshtm staff, especially prof. anne mills, are immensely thankful. the authors declare no conflict of interest. risk management and healthcare policy is an international, peerreviewed, open access journal focusing on all aspects of public health, policy, and preventative measures to promote good health and improve morbidity and mortality in the population. the journal welcomes submitted papers covering original research, basic science, clinical & epidemiological studies, reviews and evaluations, guidelines, expert opinion and commentary, case reports and extended reports. the manuscript management system is completely online and includes a very quick and fair peer-review system, which is all easy to use. visit http://www.dovepress.com/testimonials.php to read real quotes from published authors. key: cord- - ne yrc authors: ingoglia, chuck title: our voice and our vote are more important than ever before date: - - journal: j behav health serv res doi: . /s - - - sha: doc_id: cord_uid: ne yrc nan challenges ahead, and we must be prepared to meet them in the halls of congress and all the way to the white house. in state houses across the nation, legislators and elected officials at all levels are going to be faced with tough decisions extending beyond . those who represent us in government must understand and prioritize the importance of behavioral health in our nation. we must speak up and elect leaders we can depend on, taking decisive action to protect the needs of those living with mental and addictive disorders. leaders must be dedicated to ensuring that all people have access to treatment and hope of recovery without exception. the november election will be like no other. we do not know if we will gather at the polls, as we have for generations, or if voting will take a different form. whatever format, we must exercise our right to vote while prioritizing the needs of the behavioral health community and those we serve. never before has our voice been more vital in preserving our legacy and guiding our destiny; never has each vote been more critical. millions of people are depending on the outcome. however, in order to vote, you must first be registered, and far too many members of the populations we serve, the people with the greatest needs, are not registered or even aware of their rights. community mental health and addiction treatment centers are community hubs, places people go to get help. in the past, they have been at the center of the national council's get out the vote campaign, a national movement to register and educate voters. we will be working to get out the vote again this year. it may be a new approach and it may look different, but it is the same message: every vote counts! the articles in this issue of jbhs&r reflect a pre-covid- world, and as such, they help us stay grounded in the important work we do every day through pandemics and any other crisis. our work is essential and so is the research that helps us continually elevate as well as improve the care we provide. we know that early interventions are imperative and a number of the articles in this issue concentrate on youth, focusing on ways pediatric behavioral health services might intervene to reduce non-urgent emergency departments visits (in the keefe et al. paper), developing training and technical assistance centers that respond to the special needs of youth with serious emotional disorders (in the olson et al. paper), and assessing the mental health practices that have led to youth "aging out" of the system at years (in the cohen et al. paper). additionally, we focus on the importance of diversity by highlighting the nature of mental health needs among an emerging latino community with limited health care information (in the bucay-harari et al. paper) and examining how telepsychiatry might reduce treatment gaps in lgbt communities (in the whaibeh et al. paper). moreover, we recognize the individual is at the center of all care and explore ways to transition to person-centered care (in the doherty et al. paper). the past months have challenged us in unimaginable ways, as individuals, professionals, and communities. every day i am humbled by the extraordinary work each and every one of you are doing. we are all working together to get through this time and, i believe, we will look back to see that our field was an essential element of the crisis response and healing of our nation. behavioral health emergencies encountered by community paramedics: lessons from the field and opportunities for skills advancement developing an evidence-based technical assistance model: a process evaluation of the national training and technical assistance center for child, youth, and family mental health predicting child to adult community mental health service continuation mental health needs of an emerging latino community reducing the treatment gap for lgbt mental health needs: the potential of telepsychiatry transitioning to person-centered care: a qualitative study of provider perspectives key: cord- - r hlwyd authors: rhyan, corwin; turner, ani; miller, george title: tracking the u.s. health sector: the impact of the covid- pandemic date: - - journal: bus econ doi: . /s - - -z sha: doc_id: cord_uid: r hlwyd health spending has grown faster than the u.s. economy for decades and currently represents approximately % of gross domestic product. as with other sectors of the economy, the covid- pandemic has had a significant impact on this growth of the health sector and the labor force that supports it. this paper examines that impact, describing how health care spending, employment, and prices have evolved since the start of the pandemic, using data from the authors’ health sector economic indicators (hsei) series. after unprecedented drops in march and april of , both spending and employment have gradually recovered but, by the end of the summer, remained below their pre-covid levels. prices, on the other hand, have continued to rise. the paper compares these patterns with those observed in earlier recessions and describes some likely reasons for them. at nearly trillion dollars in annual revenues and % of gross domestic product (gdp), the health sector is one of the largest components of the u.s. economy and a major employer of u.s. workers. in , the sector's share of gdp was only %, comparable to other developed countries at the time (frakt and carroll ) . but in the decades since then, u.s. health spending has consistently grown faster than the rest of the economy, and now stands at nearly double the average of its peer nations in both the share of gdp going towards health spending and health spending per capita (papanicolas et al. ) . the inexorable increase in health care spending is a problem for individuals, families, businesses, government, and the overall economic health of the country. this is particularly evident when viewing federal, state, and local government budgets. about half of health care spending is publicly financed, mostly through medicare and medicaid, and the growth in health care spending continues to crowd out other priorities such as infrastructure needs and education (us department of health and human services ). these budgetary pressures will only increase as the population ages. moreover, and perhaps in part due to more spending on medical care and less spending on social services, u.s. health outcomes such as life expectancy, infant and maternal mortality, and burden of disease are worse than other comparable developed countries (bradley and taylor ) . given the importance of the health care sector to the economy, our fiscal future, and our nation's health and wellbeing, accurate and timely estimates of health sector spending, employment, and price trends are critical metrics needed to inform policy and business decisions. while traditional federal government data such as the bureau of labor statistics (bls) employment and price data, and bureau of economic analysis (bea) gdp and national income and product accounts (nipa) data, do include a health care component, health economists and policymakers most frequently cite and follow the data from the centers for medicare and medicaid services' (cms) annual national health expenditure accounts (nhea; available at https :// www.cms.gov/resea rch-stati stics -data-and-syste ms/stati stics -trend s-and-repor ts/natio nalhe althe xpend data). the nhea, reconciling information from a variety of sources (centers for medicare and medicaid services ), are released annually with about a -month lag, and provide a comprehensive look at national health spending, including by type of care and payment source. the nhea data, while thorough and well-developed, are significantly lagged, making them less useful for business and government leaders making short-and medium-term business and policy decisions. as an example, the covid- pandemic has upturned the economy and the health sector itself, yet official nhea estimates for will not be available until the end of under the usual release schedule. to fill the need for more timely tracking of the health economy, we developed (with the assistance of other current and former altarum experts) the publicly available health sector economic indicators sm (hsei; available at https ://altar um.org/solut ion/healt h-secto r-spend ing), a set of metrics and associated data briefs that provide preliminary health spending estimates on a monthly basis, while benchmarking to the cms nhea health categories and historical estimates. the hsei also include monthly tracking of additional health sector performance and economic measures including employment, prices, and implicit utilization. in this paper, we use historical and hsei data to examine the impacts of the covid- pandemic and resulting recession on the health sector, and to contrast the performance of the health sector in this recession to other downturns. following a short description of methods, the paper describes the impact of the pandemic on health sector spending, employment, and prices, and puts these trends in context by comparing the first nine months of to a comparable period during the to "great recession." we find that the current pandemic-induced recession is impacting the health sector in ways previously unseen in economic downturns. while prior recessions may have slowed the pace of growth in health sector spending and employment, this pandemic shows for the first time in our data series a massive (albeit temporary) reduction in many health sector spending and employment metrics. we briefly discuss likely drivers of these impacts and implications for future health sector trends based on our experience tracking the health sector economy over the past years. the nhea, available at https ://www.cms.gov/resea rch-stati stics -data-and-syste ms/stati stics -trend s-and-repor ts/natio nalhe althe xpend data, are published annually by the centers for medicare and medicaid services (cms), and represent the u.s. government's official accounting of national health expenditures. historical estimates are published in december and measure spending for the previous year (e.g., spending data for were published in december ) and also include occasional revisions to prior periods. total spending is partitioned by type of good or service (e.g., hospital care, physician and clinical services, retail spending on prescription drugs) and by source of funds for each good or service type (e.g., private health insurance, medicare, medicaid, out-of-pocket spending). in the spring of each year, cms also publishes -year projections of these data; the march release projected spending from through (keehan et al. ) . as we will see, these projections for have been overtaken by events. the cms historical data for indicate that health spending increased by . % from the previous year, reaching $ . trillion and corresponding to . % of gdp (hartman et al. ) . spending on the personal health care (phc) category of nhea, which excludes categories such as public health, research, and net cost of health insurance, and represents % of the total, grew by . % from . hospital spending, the largest spending category, constituted nearly one-third of total health spending, at $ . trillion. the hsei spending briefs are intended to estimate current, monthly national health spending in a manner that aligns with the annual nhea as closely as possible. the spending estimates are based on a combination of monthly health spending data published by the bureau of economic analysis and the cms historical estimates and projections. bea spending categories are matched to nhea components based on a published study that reconciles the nhea with the bea estimates (hartman et al. ) . for most nhea personal health care categories, monthly estimates are based on bea spending, adjusted to nhea by using annual ratios. for the remaining categories, national health spending estimates and projections are allocated across months by using a simple trend. annual ratio adjustments through are based on nhea actuals and ensure that monthly estimates sum exactly to nhea annual amounts. the ratios are used to adjust bea spending for months in and . important to note are particular issues that arise in estimating spending on prescription drugs from bea nipa data, due to the complex and opaque chain of financial transactions in the u.s. prescription drug market (roehrig ) . it is generally understood that the bea expenditure data for prescription drugs measures spending based on transaction prices and does not account for rebates paid by drug manufacturers directly to the insurer or pharmacy benefit manager for some branded drugs. if rebates are consistent from period to period, this will not affect our estimates of spending or price growth. in periods where rebates are growing as a share of the price, the bea data will overestimate the final net prices paid, and therefore overstate spending growth. while we have not yet found a way to correct for this potential issue in the monthly data, the final cms annual estimates do include rebates in their calculation of net spending on these drugs, correcting for any distortions rebate trends may create at the time each new annual nhea data series becomes available. the u.s. bls reports monthly on numbers of jobs by industry using data from the current employment statistics (ces) or "establishment" survey. while estimates for the most recent two months are subject to revision, these data allow for very timely tracking of trends in overall health care employment as well as employment in hospitals, physician offices, nursing homes, and other health care settings. our monthly hsei labor brief presents the most recent ces data and examines trends in health sector jobs, informed by a time series of ces data going back to january and a decade of examining the impact of the business cycle and systemic changes such as the affordable care act on health care jobs. the ces data represent numbers of jobs, as identified by establishments surveyed in each industry. as such, they may not match estimates of the number of people working in an industry obtained from a household survey such as the current population survey. our hsei labor brief data represent all types of workers employed in all settings providing health care services, including health care providers, health support occupations, and administrative and facilities staff. settings include hospitals, provider offices, clinics, home health, and residential care. we do not include employment at pharmaceutical companies, retail pharmacies located in non-health care establishments such as grocery or drug stores, or insurance companies. the primary data source for tracking health care prices is the monthly bls estimate of price levels across sectors. bls measures these price indexes by collecting data for a variety of health care products and services using surveys and direct, on-the-ground data observation of prevailing prices. the price data are made available monthly, with about a onemonth lag (i.e., september price data are available mid-to late october). to produce a combined measure of overall health sector price growth, we blend the many health care price indexes into a single health care price index (hcpi) that mirrors the annual cms personal health spending price index found in the nhea. just as the bls data are used to estimate overall economywide prices for a "market basket" of consumer goods, the hsei report the blended health care price index based on the market basket of health care products and services. the hsei data series is generated by combining a variety of bls health sector indexes, using weights for each index from the monthly spending data described above. for hospital, physician, nursing home, and home health components, producer price indexes (ppis) are the primary input to the hcpi, while consumer price indexes (cpis) are used for prescription drugs and other remaining items. available from bls in more recent years are price data broken out by payer (medicare, medicaid, private health insurance, and other payers) for overall health care services and some subcategories. these data are used to estimate underlying trends in price growth and to identify some of the market and government trends driving health sector price growth. the hsei reports also combine data on overall health sector spending and prices to estimate underlying trends in health care utilization. we calculate utilization as the residual of health sector spending growth and health sector price growth each month. it is important to note that this approach includes in hsei a measure of utilization for both direct changes in utilization (e.g., the number of prescriptions filled or the number of hospital and office visits in a period) and changes in the intensity of services provided (e.g., the number of individual services and procedures provided per visit). similar to the issue discussed in the spending methodology, estimating prescription drug price growth from bls price indexes has the tendency to overstate prescription drug price growth during periods of rising rebates. it is generally understood that the bls price indexes for prescription drugs measure transaction prices, and therefore do not account for rebates paid by drug manufacturers directly to the insurer or pharmacy benefit manager for some branded drugs. while we do not currently correct for this potential issue in the monthly price data, the final cms annual estimates do include estimates of rebates in the spending data, correcting for any distortions rebate trends may create in those series. the hsei spending brief data provide an initial look at health care spending during the covid- pandemic. they show that the year-over-year change in national health spending began to decline in march of , fell to more than % below the previous year's level in april, and then began to recover. by august , health spending had regained essentially all its losses compared with august (fig. ). to illustrate more clearly the impact of the pandemic on health spending, fig. shows time series of percent changes in major personal health care spending categories since the covid- recession began in february . it illustrates how care settings and categories have responded differently to the current crisis. spending on hospital care and physician and clinical services dropped significantly in march and april and slowly recovered by august to levels that were still somewhat below their february values. spending on dental services shows a similar but more extreme pattern, dropping by nearly % in april and remaining well below its february reading in august. spending on home health care dropped by a smaller amount in march and april, recovering to show growth in august. nursing home spending began a decline in april (one month later than most other categories) and continued to drop through august. finally, spending on prescription drugs spiked slightly in march (perhaps because people were stockpiling medications), dropped slightly, and subsequently recovered to be . % higher in august than in february. differences in these patterns appear to be associated with differences in the perceived relative risk of seeking or providing care in the pandemic environment. health spending has historically been resilient during recessions. people generally continue to pursue health care even when other parts of the economy are suffering, and government-funded health care coverage generally continues and even increases in a downturn. the difference between the covid- recession and other contemporary recessions-in addition to the speed and magnitude of the disruption-is that it was caused by a health crisis. as a result, many people avoided health care for fear of infection, and many elective health services were curtailed both to ensure adequate capacity to address a surge in covid- patients and to protect patients from unnecessary exposure. figure contrasts year-over-year changes in personal health care and six of its major components for two periods: ( ) the year ending in april , when gdp reached a minimum as a result of the recession caused by the pandemic, and ( ) the last year of the great recession, during which gdp reached its lowest point during that downturn. in april , personal health care expenditures had dropped to . % below their april level, whereas from june to june , they grew by . %. among the major categories within personal health care, hospital spending was . % lower in april than in april . spending on physician and clinical services had fallen by . % below its previous april level. spending on prescription drugs and nursing home care both were higher than in the previous april, though their year-over-year growth was lower than in the last year of the great recession. spending on home health care dropped by . %. finally, spending on dental care declined precipitously and in april was more than % below its april level. spending in all these categories grew from june to june except for dental care, which fell by . %. health spending clearly behaved differently during these two economic downturns. for additional comparison, figs. and show the trajectory of change in spending on personal health care services (i.e., personal health care minus retail sales of medical products) and the portion of nominal gdp that excludes health care services (the monthly gdp estimates come from https ://ihsma rkit.com/produ cts/us-month ly-gdp-index .html). figure covers the first months of the pandemic, while fig. includes the last months of the great recessionthe period during which gdp reached its lowest level. the figures further illustrate the significant differences between the two recessions. as measured by gdp change, the covid- recession has been much more severe than the final months of the great recession. during the great recession, health care services spending continued to grow, helping to counter the impact of the recession on declining gdp. in contrast, during the pandemic, health care services spending not only declined, but fell faster than gdp, contributing to gdp decline rather than mitigating against it. while spending in the pandemic subsequently recovered more quickly than gdp, the level of spending decline as of august continued to be below that of gdp. the hsei labor brief data taken from the bls ces show the dramatic impact of the covid- pandemic and recession on health sector employment (fig. ) . health care employment fell by . m jobs between february and april . to put this in perspective, in the years of our time series, month-to-month health care job growth has dipped negative only four times, once during and three times in -and the largest previous drop was only . health care jobs began to come back in june, although this recovery appears to be tapering off as of september . it may seem counterintuitive that health care was shedding jobs at an unprecedented rate at the height of a global pandemic. it is true that some parts of the health care system were stretched to capacity, especially early in the pandemic. however, many types of health care services were shut down and are still recovering, like other parts of the service economy. health care job losses were concentrated in ambulatory care settings such as physician offices, dental offices, and offices of other types of health care practitioners. as nonessential visits were cancelled, and states began ordering social distancing, many such offices were completely closed for a period. the increased use of telemedicine boosted volumes where remote patient-provider interactions made sense and were feasible, but these visits used less staff than typical in-person care. in hospitals, elective procedures, outpatient department visits, and general emergency department use plummeted. the resulting revenue losses led to the permanent layoff or retirement of some furloughed health workers. comparing recent health care employment trends to the overall economy, health care jobs fell a bit less steeply and have come back a bit more rapidly, but both remain below pre-covid levels. health care employment fell by % during spring , while total non-farm employment fell by %. as of the end of the third quarter , health care has regained % of the jobs lost compared to % of overall jobs regained. the pace of job recovery has been steadily slowing in both health care and the overall economy since june . as of september , the health care workforce is . % smaller than it was pre-covid- . the workforce in ambulatory care settings such as physician offices and clinics is . % smaller, the workforce in hospitals is . % smaller, and the workforce in nursing and residential care is . % smaller than it was in february . in addition to maintaining economic activity during recessions, the health care sector has traditionally run counter to other parts of the u.s. economy by continuing to add jobs. representing about one in nine non-farm jobs, health care has been a backstop to job losses in other recessions. for example, the u.s. lost . million jobs in the first years of the great recession but would have lost . million had health care not added nearly , jobs. it took more than years into the economic expansion that started in for non-health jobs to return to their pre-recession level in november , at which point health care had grown by . million jobs. in the covid- recession, for the first time, health care is contributing to instead of counterbalancing employment and economic losses. figures and illustrate the stark difference between the health care labor impact of the covid- recession and previous downturns such as the great recession. figure shows that months out from the start of the covid- recession, health care and non-health care jobs experienced similar sharp declines, followed by a gradual recovery, even though health care did not fall as far. in contrast, fig. shows the immediate divergence in health care job growth versus non-health care job declines in the early months of the great recession, a divergence that continued to widen for years. unlike the covid- pandemic impacts on health care sector spending and employment in early , the impacts on health care prices have been subtle. lower health care utilization, including the hiatuses in elective care, drops in many types of in-person visits, and the temporary closure of some outpatient offices, dramatically shrank the amount of health care spending and labor required; yet, the average prices paid for the remaining health care services appears to have changed only slightly. overall hcpi year-over-year growth has been between and % since late and, while slightly rising since february , remains within a range that would be expected given historical trends (fig. ) . over this period, economywide price growth-measured non-health care using the gdp deflator (gdpd)-has slowed, but remained positive, leading to a larger gap between health care price growth and economywide inflation. this is notable, given that health care price growth since has been at or below the level of overall inflation in the u.s. for the most recent period available at the time of writing, august , hcpi grew at a year-over-year rate of . %, contrasted with a gdp deflator value of . %. across the different health sector categories, year-overyear price growth at the bottom of the pandemicinduced recession was the greatest for nursing home care ( . %), dental care ( . %), home health care ( . %), and hospital services ( . %). year-over-year price growth for prescription drugs ( . %) and physician services ( . %) were more moderate, especially when compared to the price growth observed during the great recession, measured as of june (fig. ) . since april , health sector prices for these major categories have accelerated slightly, except for dental care, which is now at . %. the positive year-over-year growth rate in prescription drug prices, a notable and frequently cited health sector component, represents a reversion from the trend, where prices were nearly flat for the year. the slight increase in early appeared immediately in january, indicating negotiated increases in prescription drug prices were likely the driver of the increase, not pandemic-induced impacts (such as price increases driven by stockpiling behaviors observed in early spring; pagliarulo ). for health care services, where the reduction in the volume of care received could be hypothesized to result from a drop in the demand for services (given the perceived increased risk of covid- infection in health care settings and the delay of many elective procedures), one might expect overall health sector prices to fall in response. yet, price declines have not occurred, likely due to the fact that health care "markets" (and particularly the way health care prices are set) are unique, such that the limited price changes in the near term are not unexpected. first, many health care prices are set administratively through government action (including many medicare and medicaid prices), and even most private sector prices are set via negotiations between health insurers and providers, fixing unit prices for a period of time in a way that makes them unlikely to respond to changes in the short-term demand for care. moreover, some of the utilization drops were also attributable to decreases in the supply of services available, as many states in the spring of forced a pause of elective care in order to preserve space in hospitals for covid- patients and also to decrease the risk of health care setting acquired infections (gamble ) . lastly, some government responses to the pandemic included actions that may have put upward pressure on public sector health care prices to compensate for the decrease in utilization and help keep health care providers afloat. the best example that is observable in the hsei price data is the temporary increase in the federal medical assistance percentage (fmap) matching rate for medicaid services, driving up the medicaid price index in july (centers for medicare and medicaid services ). therefore, the minimal changes (and in fact slight increases) in overall health care prices paid for products and services over this period are likely explainable via a mixture of these factors. one area where "prices" have fallen dramatically over this period is in the total cost of health insurance (both for employers, their employees, and those purchasing individual insurance directly). insurers have begun issuing rebates to their customers, as underlying medical expenditures fell dramatically during the initial months of the pandemic, resulting in collected premiums far exceeding insurer expenditures on care. while data on these rebates and health insurance prices are not collected in a way that allows us to report on this "price" decrease as a price index, anecdotally, these rebates have been significant and are expected to continue as insurers reconcile their medical loss ratios (mlrs) with the minimum requirements set by the affordable care act (hall and mccue ) . for the remaining months of , we expect health care price growth to continue to exceed overall economywide rates, with nursing home, home health care, and hospital settings likely showing the fastest growth. prescription drug and physician services year-over-year price growth rates are likely to remain closer %. when looking to longer-term trends in health care prices (over the next - years), before the pandemic, some predicted a period of accelerated price growth for the sector, particularly in relation to overall inflation. driven by continued provider consolidation plus other factors, cms has predicted hcpi will rise almost twice as fast over the to period, when compared to the to timeframe (keehan et al. ) . it remains to be seen how the covid- pandemic impacts these predictions and the larger health care sector. while overall health sector price growth has not swung as dramatically as other health sector metrics during the pandemic, the price response has differed from the previous great recession period of and . during the great recession, economywide and health care price growth rates both initially slowed and, while neither year-over-year rate fell below zero, the decline was detectable in the overall hcpi for the first months of that period (fig. ). in the previous three recessions, health care price growth slowed in the initial months of the recession, but then accelerated in later months, all while economywide prices continued to fall (data not shown). this is consistent with the story of health care spending and employment, where those trends fig. health care year-overyear price growth, by major category typically run counter to overall economic trends during a recession, pulling expenditures and employment levels up during downturns. this pattern of initially falling and then rising health care prices in prior recessions is contrasted with the hcpi trend observed in , where health care prices rose almost immediately, beginning in march (fig. ). we believe a major factor in the unique hcpi change during the pandemic was the swiftness of the federal government response (including general economic stimulus) and the direct health sector support provided in initial monies. the clearest picture of this comes from the different price growth rates in the public sector (medicare and medicaid), where government policy has a bigger influence on health prices than private sector prices. figure shows the growth in hospital prices by payer in and the acceleration in public sector prices, compared to nearly constant private sector price growth. this can be contrasted with the same hospital price growth metrics during the great recession, where medicare and medicaid price growth tended to fall during the recession and post-recession periods (fig. ). lastly, as discussed in previous sections, a major difference in this covid- recession compared to prior hospital year-over-year price growth, by major payers private health insurance growth is estimated for the great recession period, as the official bls price series did not begin until . private price growth is estimated using the available total hospital, hospital medicare, and hospital medicaid price indices. hospital private insurance price growth is estimated as the remainder of averaged overall hospital price growth after including the two public insurer data sources. recessions has been the dramatic decline in overall utilization. for the first time in our hsei series since , yearover-year utilization growth has fallen significantly below zero (it was also briefly negative in and ). the net difference between personal health care (phc) spending growth and price inflation suggest that phc utilization fell by over % in april (fig. ) . this was the largest factor in the overall health care spending decline, but also the cause of the rapid recovery to near pre-covid spending levels. throughout this period, hcpi growth slightly buffered overall spending declines from the drops in utilization; yet, the drops in spending far outweighed the moderate price growth. perhaps the largest question remaining for is: when will utilization growth return to a positive contributor to overall health spending? as of august , utilization growth remained at − . % yearover-year, with the rate of the return of utilization showing signs of stalling out. some have predicted the pent-up demand for delayed health care services, expenditures associated with new covid- treatments and vaccines, and health care costs resulting from missed preventative care will drive utilization to much higher levels (kronick ), yet this remains to be seen. the impacts we have measured on the usually unperturbable health sector are one more way in which the covid- pandemic and recession are unprecedented in modern times. both health care revenues and employment have bounced back significantly since spring, but neither employment nor personal health care spending have fully recovered as we enter the final quarter of . over the fig. hospital year-over-year price growth, by major payers (great recession) utilization and price components of personal health care spending year-over-year growth same period, health care prices have continued to rise, now outpacing economywide price growth by a larger margin. this recession also represents a rare interruption in the growth in health care spending and employment that has been relentless for decades, and so at a minimum has likely reset both to a level lower than what would have been, absent the pandemic. the extent to which any permanent reductions are good or bad for our health and our economy will be a major part of the u.s. health services research agenda. the american health care paradox: why spending more is getting us less families first coronavirus response act-increased fmap faqs the quality imperative a commentary on the which hospitals have suspended elective surgeries? a list, state by state. becker's hospital review how the aca's medical loss ratio rule protects consumers and insurers against ongoing uncertainty a reconciliation of health care expenditures in the national health expenditures accounts and in gross domestic product growth driven by accelerations in medicare and private insurance spending expected rebound in prices drives rising spending growth how covid- will likely affect spending, and why many other analyses may be wrong pharmas boosted by drug stockpiling, but warn of covid- impact health care spending in the united states and other high-income countries the impact of prescription drug rebates on health plans and consumers, who benefits from manufacturer drug rebates? altarum institute the effect of health care cost growth on the the authors would like to thank the robert wood foundation for its support of the work. publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.corwin rhyan mpp, is a senior analyst for altarum's center for value in health care (cvhc), where he has led many projects on the economics of the health care sector including studies of the social determinants of health, prevention, and the economic burden of disease. his work has included studies on childhood lead exposure, behavioral health care access and utilization, maternal prenatal interventions, obesity prevention, and the opioid epidemic. he has also completed studies on health spending trends at the state level, including work in minnesota and virginia, and has assessed the prevalence of low-value care and waste using medical claims. he has studied a broad range of topics on the economics of the us health care system and assisted in the production of altarum's health sector economic indicators, blogs, and research briefs. he holds a master's in public policy from the university of michigan gerald r. ford school of public policy and a bachelor of arts in economics, magna cum laude, from washington university in st. louis.ani turner ma, is director of sustainable health spending strategies at altarum's center for value in health care, where she studies drivers of health spending, trends in the health workforce, and the economic impacts of investments in social and environmental factors that determine health and life outcomes. with years of experience in health-focused data analysis and policy research, she has developed forecasting models and studied health care resources, costs, and quality for the federal government, states, health plans, and foundations. she leads the center's health workforce research and partnership with the w. k. kellogg foundation making a business case for greater racial equity as a path to a stronger workforce and economy. she serves as chairman of the board for st. joseph mercy health system ann arbor/ livingston. she holds a bachelor's degree in mathematics, summa cum laude, and a master of arts in applied economics with a concentration in labor economics, both from the university of michigan. key: cord- -uxtaw u authors: chowdhury, anis z.; jomo, k. s. title: responding to the covid- pandemic in developing countries: lessons from selected countries of the global south date: - - journal: development (rome) doi: . /s - - -y sha: doc_id: cord_uid: uxtaw u reviewing selected policy responses in asia and south america, this paper draws pragmatic lessons for developing countries to better address the covid- pandemic. it argues that not acting quickly and adequately incurs much higher costs. so-called ‘best practices’, while useful, may be inappropriate, especially if not complemented by effective and suitable socio-economic measures. public understanding, support and cooperation, not harsh and selective enforcement of draconian measures, are critical for successful implementation of containment strategies. this requires inclusive and transparent policy-making, and well-coordinated and accountable government actions that build and maintain trust between citizens and government. in short, addressing the pandemic crisis needs ‘all of government’ and ‘whole of society’ approaches under credible leadership. test for the 'international community' since the un's formation. he urged developed countries to immediately help less developed countries to bolster their health systems and capacity to check disease, especially covid- transmission. failure to do so, he warned, would contribute to 'the nightmare of the disease spreading like wildfire in the global south with millions of deaths and the prospect of the disease re-emerging where it was previously suppressed'. early precautionary measures in much of the rest of china and east asia, and in places such as kerala state in southwest india, were largely successful in containing the spread of the epidemic, at least thus far. but most national authorities outside of east asia did not take adequate early precautionary measures speedily enough to contain the spread of the outbreak, typically by promoting safe 'physical distancing', obligatory use of masks in public areas, and other measures to reduce the spread and likelihood of infection. societal vulnerability to infection and capacity to respond depend on many factors, including health care system preparedness, leadership experience and ability to manage specific challenges posed. government capacity to respond depends crucially on system capacity and capabilities-e.g., authorities' ability to speedily trace, isolate and treat the infected-and available fiscal resources-e.g., to quickly enhance testing capacity and secure personal protective equipment (ppe). funding cuts, privatization and other abuses of recent decades-in the face of rising costs, not least for medicines-have further constrained and undermined most public health systems, albeit on various different pretexts. of course, socio-cultural factors, such as more cooperation due to greater 'trust' in the authority, less individualistic and narcissistic cultures, and even the shared memory and experience of past outbreaks such as sars and nipah, have also been important. this review seeks to draw pragmatic lessons for developing countries to better address the covid- pandemic. it begins with a brief discussion seeking to understand distinctive characteristics of the pandemic infecting a large share of the world's population. it then evaluates the principal strategies adopted to address the health crisis, especially to enable national health systems to cope with the emergency. it is followed by reflections on the causes and implications of public health capacity vulnerabilities in developing countries. finally, it draws some implications of different policy responses in east asia, southeast asia-especially vietnam, and india's kerala state-argentina, brazil and peru, that are relevant for other countries. it argues that the costs of not acting quickly and adequately are higher. it further argues that so-called 'best practices', while useful, may be inappropriate, especially if not complemented by effective and suitable socio-economic measures. high degrees of public support and cooperation are critical for successful implementation of containment strategies without having to resort to wasteful and self-defeating draconian measures. this requires inclusive and transparent policy-making, and well-coordinated and accountable government actions that build and maintain trust between citizens and government. in short, addressing a pandemic crisis of this scale needs 'all of government' and 'whole of society' approaches under credible leadership. the covid- pandemic, caused by the sars-cov- virus, is now widely considered more infectious than other viral epidemics in last century following the spanish flu pandemic, especially since the deadly asian flu of the late s and hong kong flu of . the covid- fatality rate is lower than for the first severe acute respiratory syndrome (caused by sars-cov- ) in [ ] [ ] and is not more infectious than the h n virus, but has infected many more people nonetheless. several factors have made covid- more dangerous than other recent viral epidemics. first, its symptoms and consequences are rather diverse and can be quite severe, varying with age. for example, while covid- primarily affects the respiratory system, causing pneumonia, it has also been associated with gastrointestinal and neurological manifestations (christakis ) . those infected may also mistakenly attribute their symptoms to influenza or other health conditions. importantly, those infected with the sars-cov virus may be infectious well before showing any symptoms, seven coronavirus varieties have infected humans thus far: four caused sniffles, one caused the deadly mers outbreak in the middle east, first reported in saudi arabia in , with two others causing major international epidemics. the first caused sars, which petered out quickly, despite its high fatality rate, while the other causes according to the who, a total of , people in countries had sars; died between november and july , i.e., a death rate of . %, whereas the covid- death rate was . %, when it was declared a pandemic (woodley ) . consider two pathogens, x and y. for every thousand people, both cause people to become seriously ill, killing two each. but the second pathogen y also infects more people, only making them mildly or moderately ill, i.e., not killing them. so, the 'case fatality' rate (number of deaths per infected person) for x is % ( out of ), whereas for y, it is % ( out of ). but although this rate is lower for the second pathogen, y, it is no less lethal (christakis ) . 'transcript of the un secretary-general's virtual press encounter to launch the report on the socio-economic impacts of covid- ′. united nations https ://www.un.org/sg/en/conte nt/sg/press -encou nter/ - - /trans cript -of-un-secre tary-gener al%e % % svirtu al-press -encou nter-launc h-the-repor t-the-socio -econo mic-impac ts-of-covid - . accessed august . while as many as half of those infected, and hence infectious, may be asymptomatic, i.e., not show any symptoms of illness. hence, reliable new cheap and rapid tests for covid- infection promise to be a major 'game-changer'. r is the average number of individuals that an infected person infects when no interventions have been implemented; this number does not change. the 'reproduction rate'-referred to as r t or r e depending on preference or convention-will likely change as interventions are put in place, while the number of those susceptible changes due to infection and possible immunity. major variations due to 'super spreader' episodes further complicate understanding of the significance of average rates and of variations. while 'super-spreader' episodes have received much publicity, they have been exceptional with a lower variation in r t and hence less important for explaining contagion than 'normal' networks of viral transmission of covid- . again, with a lower fatality rate-the probability of a person dying-covid- has been particularly hard to contain as there are more infectious people around than if it were more deadly. hence, movement restrictions, physical distancing, self-isolation and other precautionary and preventive measures are important. the virus can spread from person to person during close direct or indirect contact with an infectious person (even before they have symptoms), contact with aerosol-or droplet-borne virus from an infected person, either directly or indirectly. infection, via mucous membranes in the mouth, nose or eyes, starts in the upper respiratory tract, typically in the throat or upper airways. elderly persons and people with other health issues, such as asthma, diabetes, obesity, hypertension, etc. are more vulnerable, and likely to face complications and death. improved understanding of covid- has been critical for designing and improving policy responses. the sars-cov virus was considered novel as it had never been seen in humans before. thus, initial responses in east, including southeast asia were drawn from known 'best practices' for testing, contact tracing, isolation and treatment. but, for various reasons, even these were not done in most countries outside asia. once the virus had spread widely, it was no longer practical or even possible to belatedly implement best practices effectively as case-loads not only overwhelmed hospitals, but also public health systems. differences with earlier viruses and epidemics meant that simple emulation of past containment measures have not always been appropriate, let alone optimally effective for containing covid- . government policymakers need to consider the general nature and specific variations of the covid- pandemic and its uniquely changing and varied implications in particular contexts. a standardized set of interventions, even ostensible best practices, is unlikely to be universally applicable, as the covid- pandemic has different ramifications in varied circumstances over time. the incubation period will require corresponding periods of quarantine or 'self-isolation'. the varied duration of 'mismatches'-e.g., due to incubation exceeding, or lasting longer than latency periods -imply that countries need to urgently acquire the ability to rapidly and reliably test as widely as necessary. as this has not been affordable for many, especially in poorer countries, the development of cheap, quick and reliable tests promises to be crucial. once widely available and used, such improvements in the speed, reliability and affordability of testing will have significant consequences. no one can be exempted from preventive or containment measures until it is definitively medically confirmed that all those once infected can be neither infected or infectious again. for the time being, face masks and shields, physical distancing and hand hygiene remain vital to containment efforts. the long-term health and economic impacts of covid- imply that public health and social protection systems should be well prepared to manage them. unfortunately, persuaded by the most influential, early western discourses, many politicians and others everywhere did not take the contagion threat seriously enough initially covid- appears to have lower r variation than sars, for example. this explains why the ebola epidemics with a terrifying fatality rate - % waned reasonably quickly. the period between becoming infected with a pathogen and showing symptoms is called the 'incubation period'. the 'latency period' is the time between becoming infected and being able to spread the disease to, i.e., infect others. there can be mismatches between the virus incubation period and the latency period. when the latency period is longer, an infected person may only display symptoms after they have actually become infectious, i.e., capable of infecting others. the sars-cov virus incubation period is generally longer than the latency period. thus, an infected person can spread the virus before symptoms of having covid- are visible. a saliva-based laboratory diagnostic test developed by researchers at yale to determine whether someone is infected with the novel sars-cov- virus was granted emergency use authorization by the us food and drug administration (fda) on august . with the technique made available on an open access basis, the cost and speed of testing can be radically reduced for all, with major implications for current precautionary and preventive practices and requirements. https ://news.yale.edu/ / / /yales -rapid -covid - -saliv a-test-recei ves-fda-emerg ency-use-autho rizat ion. accessed august . since june, south africa has been conducting trials for a -min covid- breath test, while israeli scientists claim to have developed a -s coronavirus breath test. https ://www.the-scien tist. com/news-opini on/in-south -afric a-covid - -breat h-test-trial -set-forjune- ; accessed august ; https ://medic alxpr ess.com/ news/ - -israe li-firm-secon d-coron aviru s.html. accessed august . for various reasons. these include not only cultural prejudice, but also misinformation and confidence in alternative approaches, such as 'herd immunity', all facilitated by the greater influence of social media. if and when an effective vaccine becomes available, there is no guarantee that it will be affordable and available to all without a strong multilateral commitment to ensure that it quickly becomes universally accessible. furthermore, there are likely to be significant populations who may refuse to be vaccinated en masse, e.g., where civil libertarian ideologies and mistrust of vaccines and authorities are pervasive. without such a shared commitment to universal access, it may be impossible to completely eradicate the covid- threat in the foreseeable future. recent us actions have not been encouraging for a concerted global response to the pandemic. as the largest financial contributor, the us decision to formally withdraw from the who will certainly hamper its efforts, not only for dealing with the current pandemic, but also for preventing or preparing for the next viral epidemic (mckeever ). earlier in april, president trump, using a korean war-era law, sought to redirect surgical masks manufactured by the us transnational firm m in other countries to the us, and to stop exporting masks manufactured by the company in the us (swanson et al. ). the us confiscated , us-made face masks bound for germany in bangkok, and redirected them back to the us for use there, a move the german minister condemned as 'modern piracy'. us buyers also offered three times more to secure face masks from china destined for france (willsher et al. when the who declared covid- a 'pandemic' on march , more than % of cases were in four countries (china, iran, italy and south korea), with new infections declining significantly in china and south korea, countries reporting no cases, and reporting cases or less (world health organization a). then, the who director-general (dg) expressed the hope that countries could still check the pandemic by mobilizing resources to detect, test, isolate, trace and treat those infected, quarantining them while they remain infectious. however, only a handful of east and southeast asian economies and kerala state in southwest india acted early, urgently and adequately, thus avoiding highly disruptive total lockdowns and associated human and economic costs. they also secured greater community support for containment, while minimizing draconian enforcement measures. had far more countries done so, while requiring safe physical distancing, mask wearing and other precautionary measures, the contagion could have been contained. and where communities or clusters had significant infection rates, urgent, targeted measures could have helped 'turn the tide' on covid- with decisive early actions, as in china, korea and vietnam, without imposing nationwide 'stay in shelter' or 'shelter in place' lockdowns, or restrictions on movements of people within its borders. lulled into complacency, most others were slow to respond, with some hoping or expecting the virus would bypass them, or believing that 'herd immunity' would protect most exposed to the virus. a few headstrong, but very influential government leaders refused to acknowledge the severity of the covid- threat, distracting many with conspiracy theories and 'blame games', instead of quickly learning from and correcting policy errors made as new knowledge became available. in the uk, developing 'herd immunity' in the population, by allowing the epidemic to spread, prevailed as official policy until the first imperial college of london (icl) study was issued on march. much harm could have been avoided if early precautionary actions had been taken. more than world leaders and experts signed an open letter before the world health assembly (wha) began on may, calling on governments to commit to a 'people's vaccine' against covid- , also calling for all vaccines, treatments and tests to be patent-free, mass produced, fairly distributed and available to all, in every country, free of charge https ://www.unaid s.org/en/resou rces/press centr e/ press relea seand state menta rchiv e/ /may/ _covid -vacci ne. accessed august . although the leaders of china, germany, france, norway and italy pledged at the wha to make vaccines developed in their countries a global public good, the usa remains non-committal. the united nations secretary-general also emphasized that everybody must have access to the vaccine when available. the wha unanimously acknowledged that vaccines, treatments and tests are global public goods, but was vague on the practical implications of the declaration. since then, the us, the uk, australia and other countries have signed up with the developers of 'candidate vaccines' to secure supplies for their own countries. 'ceasing all export of respirators produced in the united states would likely cause other countries to retaliate and do the same, as some have already done', m said. 'if that were to occur, the net number of respirators being made available to the united states would actually decrease. that is the opposite of what we and the administration, on behalf of the american people, both seek' (swanson et al. ). https ://www.bbc.com/news/world - . accessed august . the who maintained that physical distancing, 'effective' hand washing and related sanitary practices were the most effective, practically 'do-able' and affordable, and apparently did not want to distract from such 'non-pharmaceutical interventions'. one problem has been that many people believe that wearing masks is sufficiently protective in lieu of physical distancing and hand washing. but the use of protective face masks was actively discouraged by some national authorities, citing the very same who as the policy authority. the ostensible reason was to ensure adequate personal protective equipment (ppe) for 'frontline' workers, a view first associated with us presidential adviser, anthony fauci, as panic buying exhausted supplies and raised prices. thus, new infections and deaths quickly rose exponentially as the epidemic rapidly spread to other countries, especially to advanced countries in the west, better connected by passenger air travel. as developing countries struggle with inadequate vitally needed resources, many developed countries have acted in a jingoistic way by restricting exports of vital medical supplies, in contravention of the ihr and who recommendations. the principal strategy adopted by most governments is to 'flatten the curve', so that countries' health systems can cope with new infections by tracing, testing, isolating and treating those infected until an approved vaccine or 'cure' is available to all. but this is easier said than done. if testing, contact tracing and other early containment measures had been adequately done in a timely manner to stem viral transmission, nationwide lockdowns would not have been necessary, and only limited areas would have had to be locked down for quarantine purposes. the effectiveness of containment measures, including lockdowns, are typically judged primarily by their ability to quickly reduce new infections, 'flatten the curve' and avoid subsequent waves of infections. however, lockdowns can have many effects, depending on context, and typically incur huge economic costs, unevenly distributed in economies and societies. most 'casual' labourers, petty businesses reliant on daily cash turnover, and others in the 'informal' economy typically find it especially difficult to survive extended lockdowns. hence, success should not be measured by lockdown duration, enforcement stringency or even temporary declines in new cases. governments must be mindful of costs, including disruptions, and also of how policies affect various people differently. lockdowns have undoubtedly set back economic and social progress and people's welfare, but public policy should be directed to make such setbacks reversible, and to ensure they do not deliver economic 'knockouts' to the vulnerable. good planning, implementation and enforcement of movement restrictions, as well as adequate provisioning for those adversely affected, are crucial, not only for equity, efficacy and compliance, but also for transitions before, during, and after lockdowns. physical distancing, mask use and other precautionary measures, besides mass testing, tracing, isolation and treatment, have been able to check the contagion without resorting to draconian 'stay in shelter' lockdowns. such measures have been quite successful so far in much of east asia, vietnam and kerala. precautionary measures must be appropriate and affordable. those living in crammed conditions, e.g., urban slums, cannot realistically be expected to consistently practice safe distancing, but can nonetheless be enabled to sustainably take other precautionary measures within their modest means, e.g., by using washable masks or reusable shields in public areas. to minimize the risk of infection, authorities can encourage and enable, if not require, changes that demand 'physical distancing' in social interactions, including work and other public space arrangements, e.g., for offices, factories, shops, public transportation and classrooms. health systems in most developing countries are unevenly inadequate, even in normal times. despite several pandemics in recent years, most countries have remained poorly prepared, even for the specific challenges posed by covid- . even many health systems in europe and north america have faced major shortages of doctors, respirators/ventilators, basic infection prevention (bip) gear, ppe and testing kits. https ://apps.who.int/iris/bitst ream/handl e/ / /who-ncov-ipc_masks - . -eng.pdf?seque nce= &isall owed=y. accessed august . owing to the critical shortage of medical masks, the who's initial advice was to prioritize the use of face masks for people with covid- symptoms, those looking after those infected and other 'frontline' personnel. the who revised its policy with new interim reccomendations on june , https ://www.who.int/publi catio ns/i/ item/advic e-on-the-use-of-masks -in-the-commu nity-durin g-homecare-and-in-healt hcare -setti ngs-in-the-conte xt-of-the-novel -coron aviru s-( -ncov)-outbr eak. a recent survey of the availability of four bip and four ppe items in seven poor countries (afghanistan, bangladesh, democratic republic of congo [drc], haiti, nepal, senegal and tanzania) found less than a third of clinics and health centres in bangladesh, the drc, nepal and tanzania had any face masks (gage and bauhoff ) . in all seven countries, clinics and health centres, often the first point of public contact with the health system, had, on average, just . (of four) bip items and two (of four) ppe items. most countries also scored poorly on health workers' preparedness with reference to the ihr to prevent disease spread. while the us has about intensive care unit (icu) beds per , population, the ratio is around per , in india, pakistan and bangladesh in south asia. in sub-saharan africa, the situation is even more dire: zambia has . icu beds per , , gambia . , and uganda . (malley and malley ) . in of africa's countries, total icu beds number less than , or about beds per million, compared with about per million in europe. there are also serious respirator shortages in africa, with african countries together having fewer than as of mid-april, and ten with none at all, while the us had , respirators in mid-march (maclean and marks ). the average low-income country has . physicians and . nurses per thousand people, compared to . and . respectively in high-income countries (gage and bauhoff ) . global markets for crucial who designated covid- products are highly concentrated (espitia et al. ). the eu, us, china, japan and korea-account for % of total imports. the import shares of products needed for case management and diagnostics are even higher, close to %. import shares for ppe and hygiene products are somewhat lower, around - %, requiring countries to compete on the basis of their respective means, regardless of need. developing countries are also extremely vulnerable to changes in exporter policies, such as export restrictions on covid- tests, treatments and ppe. besides affecting availability, export restrictions-supposedly due to domestic shortages-have pushed up world prices. espitia et al. ( ) estimate that current export restrictions could initially increase prices of medical masks by . %, venturi masks by . %, and protective equipment, such as aprons and gloves by % and % respectively. if exporting countries tighten export restrictions in response to domestic price rises, prices of such covid- relevant goods could rise by % on average; most affected would be ppe, such as aprons ( % increase) as well as goggles and masks ( % increase) (espitia et al. ) . therefore, as high-income countries scramble to secure crucial supplies such as face masks, low-income countries face much tougher choices. their budgets are far more limited, and they typically lack local producers for most ppe, relying on donors and multilateral organizations for procurement in the face of unreliable supply chains. the covid- threat to frontline health workers in lowincome countries has been largely ignored. only a small fraction of needed ppe has gone to them. the who has dispatched . million ppe sets, while unicef has dispatched , n masks, . million gloves and other ppe. billionaire philanthropist jack ma has donated , masks and protective suits each to every african country and . million masks to asian countries (gage and bauhoff ) . in recent decades, developed economies, through the imf and world bank, have used aid conditionalities to demand fiscal cuts and neoliberal health reforms, e.g., by imposing user fees in developing countries (lister and labonté ) . instead of improving efficiency, quality and coverage, these reforms have had deleterious implications for public health, besides exacerbating inequalities in access to health care (stubbs and kentikelenis ; forstera et al. ; sobhani ) .their structural adjustment programmes in developing countries, particularly in africa, have resulted in underinvestment in health care systems, causing them to be poorly prepared to respond to the ebola epidemic (nkwanga ) . besides imf and world bank programmes, such underinvestment was also due to compromised fiscal capacities and regressive fiscal priorities (sanders et al. ; scott et al. ). with no known effective treatment for the infection, as the deadly nature of the virus became clear, many countries, even the world's most 'advanced' and richest, have adopted draconian measures, such as total or nationwide 'stay in shelter' lockdowns, often in panic and ignorant of other options. accustomed to adopting supposed 'best practices' prescribed by the rich and powerful, all too many developing country governments are implementing such measures without sufficiently taking into account country-specific circumstances and other challenges. besides the obvious differences between developed and developing countries, especially in terms of resources, demography, governance and other institutional capacities, there are significant differences among the developing countries themselves. in most slums and villages, many people often live together in one or two rooms, sharing common facilities. safe physical distancing is virtually impossible in such circumstances. even basic hygiene and other prescribed sanitary measures are not easy when even clean running water is scarce. most of the population in many developing countries is in the informal sector, earning meagre, typically daily incomes, and with paltry savings. all too many developing countries do not have enough fiscal space to provide sufficient relief for vulnerable populations and small businesses for very long. hence, extending strict lockdown measures and causing an economy to be locked down for too long may erode public support, even if high at the outset. but as it is often too late to rely solely on early preventive and precautionary measures, authorities typically see no choice but to implement strict and effective contagion containment at the expense of disrupting livelihoods. this dilemma is often misrepresented as choosing between life and the economy. transmission patterns are determined by many factors, some social, local and intimate. international and even national public health decision makers are often oblivious to some such factors, which community members know all too well. therefore, joint learning, involving both experts and affected communities, can be vital for effective responses. brazil and peru are two of the worst hit countries in latin america, but for different reasons. while the failure in brazil has been due to complacency, denial and lack of national/ social solidarity, the peruvian setback has been due to poor design of relief measures. despite life-threatening risks, brazil's president bolsonaro chose to emulate us president trump, infamously comparing the covid- threat to a 'little flu' or 'cold', even dismissing it as a media-hyped 'fantasy (borges ) . he also dismissed preventive measures as 'hysterical' and repeatedly demanded that state governors withdraw their physical distancing and stay-in-shelter lockdown orders. displeased by his public remarks on the need for lockdowns and physical distancing, bolsonaro fired his health minister, causing outrage across brazil. lockeddown citizens of brazil protested, even charging 'bolsonaro murder' (quinn ) . instead of an 'all of government' approach, bolsonaro also started disputes with brazil's congress and supreme court (oliveira ; santos ; bbc news ) . peru, on the other hand, acted early and as decisively as argentina, but met with different outcomes. peru imposed lockdowns, closed schools and borders, cancelled international flights, and introduced relief measures. but its response was flawed as the government had not sufficiently considered the country's socio-economic conditions. for example, most poor peruvians living in slums do not have bank accounts, and had to stand long hours queuing for cash relief grants. ironically, this became a major cause of contagion (ghitis ) . the government's relief and preventive public health measures did not address the needs of the most vulnerable sectors of society, including the poor, self-employed, informally employed, indigenous communities and indebted middle-income households. rather, the government targeted its subsidies at large companies, who were presumed to be the major employers. its safety-net programmes were based on census and municipality records, suffering serious data deficiencies. hence, government measures barely reached those in greatest need (martínez ) . more than % of peru's population live in extreme poverty, with around % in the informal sector depending on daily work for their livelihoods. while poor people, especially in cities, find it almost impossible to comply with lockdown restrictions as they struggled to survive, officials and much of the media portrayed them as 'irresponsible'. trust and community support for government measures were undermined with the revelation of corruption scandals in the procurement of sanitary, protective, testing, medical and other supplies (martínez ) . other resource constrained developing countries, like vietnam and argentina, and india's kerala state have tackled the pandemic far more effectively, at low cost and with impressive results. some key features of their policy responses are highlighted below: the kerala state government invited religious leaders, local bodies and civil society organisations (csos) to participate in policy design and implementation. it refused to use the term 'social distancing', which has caste and class connotations, and instead emphasized 'physical distancing' as part of a more socially inclusive approach to more people-centric development practices based on social solidarity. it carefully crafted political messages, such as 'break the chain', with larger political connotations, e.g., breaking the chains of oppression and popular emancipation. instead of using the pandemic for political advantage against argentina's long history of fiercely divisive politics, president alberto fernandez invited and stood together with leaders from across the political spectrum when he announced lockdown measures on march in a rare display of national political consensus (gillespie and do rosario ) . social, religious and business groups partnered to deliver food cartons to more than two million people in buenos aires and the surrounding areas (alcoba ) . the argentine national government has worked closely with opposition party state governors, as well as private and union-linked health providers to secure private cooperation without nationalization (who c). fernandez organized another display of national unity to announce that argentina would not pay external creditors while dealing with the pandemic, demanding favourable debt-restructuring terms, a bold approach which appears to be working. the kerala state government mobilized more than , volunteers to help implement various infection control measures. it successfully mobilized csos to support its 'break the chain' awareness campaign, and got numerous micro-enterprises to produce hand sanitizers and face masks, while distributing interest-free loans worth billion rupees to needy families (krishna ) . in vietnam, citizens were encouraged-via social media, text messages and tv broadcasts-to donate to the campaign to buy medical and protective equipment for doctors, nurses, police and soldiers in close contact with patients, and for those quarantined. both the kerala and vietnam governments took measures to prevent stigmatization. the kerala government organized hundreds of community kitchens with the help of csos and local-level leaders to discreetly deliver free meals to those infected with the virus, without publicly identifying them to avoid possible social stigmatization (krishna ) . in vietnam, the identities of those infected were protected by only referring to them by their case numbers. when local businesses were reportedly ostracizing foreigners, vietnam's prime minister spoke out against such discrimination. such measures encouraged people to be more open and cooperate fully in contact-tracing, testing and treatment. administrations that have successfully managed the pandemic have mobilized the all of government and demonstrated effective coordination among government departments and between their various layers. for example, the kerala government set up inter-departmental committees involving all branches of government, which meet daily to evaluate the situation. vietnam's national steering committee for covid- prevention and control was nicknamed the 'general headquarters'-a reference to a military coordinating body in existence until the war ended in . in argentina, the chief of the cabinet of ministers has responsibility for the 'general coordination unit of the comprehensive plan for the prevention of public health events of international importance'. the kerala government organized daily press conferences, when the state health minister and chief minister calmly explained what was going on and what her department was doing. communities were provided with essential epidemiological information to better understand the threat and related issues, to ensure compliance with prescribed precautionary measures and to avoid inadvertently causing panic. vietnam has not shied away from broadcasting the seriousness of the covid- threat, with the ministry of health's online portal immediately publicizing each new case with details including location, mode of infection and action taken. exceptionally, vietnam's communist partyled government published the identity and itinerary of a prominent party figure who had tested positive (vinh le and nguyen ). instead of communicating in traditionally formal ways, the government has been creative, e.g., by teaming up with two famous pop singers to produce, promote and broadcast an effectively educational song about the threat. it has also commissioned artists to create posters, and mobilized influential youth figures to broadcast supportive messages to raise the morale of those quarantined and others as appropriate (bui ). some governments and other authorities designed effective relief measures with consideration of challenges posed by specific conditions, including urban slum environments. for example, argentina's president alberto fernández ensured that no essential services-electricity, gas, water, mobile services, fixed landlines, internet and cable television-were cut for retirees, social welfare recipients and low-income households on account of non-payment of bills (sugarman ). argentina's government has devoted over us$ million for food assistance alone. at national, provincial and municipal levels, the government has supported public kitchens, while the president has promised those in desperate circumstances the food and other resources needed to survive (alcoba ) . in a similar vein, the kerala state government has organized the physical delivery of food, medicine and other essentials as well as necessary services to those under lockdown (krishna ) . it took immediate actions to reduce the risk of hunger and starvation of the poorest segments of the population by organizing free rations for all for a month, distributing food kits, consisting of items for every household, irrespective of income status (pothan et al. ) . kerala and vietnam have been internationally acclaimed as role models, especially as they are both considered poor, and suffering resource constraints. by acting early, decisively and inclusively, kerala and vietnam successfully avoided highly disruptive total lockdowns as well as associated human and economic costs. they achieved a high level of buy-in and popular support for their governments' covid- containment measures. as they achieved a high degree of voluntary compliance, draconian enforcement measures to 'flatten the curve' did not have to be imposed. while covid- crisis challenges are undoubtedly unique, they are not exceptional insofar as such challenges all have unique characteristics. nevertheless, the challenges have probably been far greater than for other recent epidemics, raising questions about earlier tested modes of response. full social mobilization is undoubtedly needed, but such exceptional 'emergency' or even 'wartime-like' measures must not be abused, e.g., by the temptation to skew implementation for despotic, political or pecuniary advantage. hence, success can be greatly enabled by legitimate, credible and exemplary leadership, government and otherwise. countries can have less disruptive and less costly, but yet very effective containment strategies, especially if they act early, quickly and adequately. the ability to trace and test as many suspected cases as possible, e.g., those who have recently come into close physical proximity with an infected person, is also crucial. effective containment depends heavily on voluntary compliance, and hence, community acceptance and trust, helped by transparency and shared understanding of what needs to be done. all these require state capabilities working together ('all of government') as well as credible and inclusive leadership to mobilize and co-ordinate the 'whole of society' for effective containment of contagion, as in the southwest indian state of kerala and vietnam. bbc news. . brazil. federal court prohibits government from running campaign against social isolation a little flu': brazil's bolsonaro playing down corona virus crisis trump's trade policy is hampering the us fight against covid- . peterson institute for international economics aggressive testing and pop songs: how vietnam contained the coronavirus. the guardian fighting covid- by truly understanding the virus. the economist trade and the covid- crisis in developing countries public health experts: coronavirus could overwhelm the developing world - d f- ea-a - b cdb _ story globalization and health equity: the impact of structural adjustment programs on developing countries health systems in low-income countries will struggle to protect health workers from covid- why even peru's top-notch plans failed to stop the coronavirus pandemic argentina sacrifices economy to ward off virus, winning praise india's kerala is combating covid- through participatory governance. the bullet globalization and health: pathways, evidence and policy african countries have no ventilators. the new york times when the pandemic hits the most vulnerable: developing countries are hurtling toward coronavirus catastrophe peru passes coronavirus risk to working class here's what we'll lose if the u.s. cuts ties with the who covid- will hit the developing world's cities hardest. here's why the ebola crisis in west africa and the enduring legacy of the structural adjustment policies alexandre de moraes suspends section of mp that changed rules of the access to information law. policy controlling covid- will carry devastating economic cost for developing countries. conversation local food systems and covid- ; a glimpse on india's responses. fao, april bolsonaro fires brazil's health minister as infections grow. foreign policy ebola epidemic exposes the pathology of the global economic and political system judge suspends bolsonaro decree that takes churches and lottery out of quarantine. conjur newsletter critiquing the response to the ebola epidemic through a primary health care approach from privatization to health system strengthening: how different international monetary fund (imf) and world bank policies impact health in developing countries international financial institutions and human rights: implications for public health argentina is showing the world what a humane covid- response looks like, the nation trump seeks to block m mask exports and grab masks from its overseas customers. the new york times how vietnam learned from china's coronavirus mistakes. the diplomat us hijacking mask shipments in rush for coronavirus protection. the guardian covid- will hit developing countries hard. financial times how does coronavirus compare with previous global outbreaks? the royal australian college of general practitioners service availability and readiness assessment (sara) world health organization (who). a. who director-general's opening remarks at the media briefing on covid- world health organization (who). b. rational use of personal protective equipment (ppe) for coronavirus disease (covid- ) argentina: there is no economy without health. who the article is based on authors' opinion pieces in inter press service (ips) news agency, which can be assessed at https ://www.ipsne ws.net/autho r/anis-chowd hury/; and https ://www. ipsne ws.net/autho r/jomo-kwame -sunda ram/. the authors would like to thank professor mj cardosa for her advice, comments and suggestions to improve the readability of the article, and lim siang jin for his editorial advice, but implicate neither in the final version. key: cord- -tx hciiv authors: engda, tigist title: the contribution of medical educational system of the college of medicine, and health sciences of the university of gondar in ethiopia on the knowledge, attitudes, and practices of graduate students of health sciences in relation to the prevention and control of nosocomial infections during the academic year of date: - - journal: bmc med educ doi: . /s - - - sha: doc_id: cord_uid: tx hciiv background: nosocomial infection, also called a hospital-acquired infection, is an infection acquired during admitting patients in health care facilities. nosocomial infection can be prevented and controlled by giving training to those responsible. this study aimed to assess the contribution of the medical education system on the knowledge, attitudes, and practices of the graduate students of health sciences about the prevention and control of nosocomial infection in the college of medicine and health sciences at the university of gondar in the academic year of . method: an institution-based cross-sectional study was conducted among all graduate health science students posted in the different departments at the university of gondar in the college of medicine and health sciences from february to june . a total of study participants were included. data were analyzed using spss version . results: out of a total of respondents, only % have taken training for infection prevention; out of which % had taken the training for a year ago. moreover, only . % have good knowledge of nosocomial infections as a result of the training; and only . % have good understanding of the practical training given on prevention and control. only % have good attitude towards its prevention and control. conclusion: the result shows that only a few of the respondents have taken the infection prevention training. yet, a smaller proportion of them had good knowledge, attitude, and practice on nosocomial infections. hence, the medical education system should give more attention to the training of the nosocomial infection control by developing different strategies to prepare the students on these issues before they start their clinical attachment. nosocomial infection is a localized or systemic infection that is acquired in a health care facility that may manifest h after the patient's admission to or discharged from the health care facility [ ] . it can be caused by bacteria, viruses, parasites, and fungi that may be present in the air, surfaces, or equipment surrounding the health institutions [ ] . it can affect patients of all age groups; however, neonates, immunocompromised adults, and the elders are the most vulnerable ones [ , ] . nosocomial infections have been recognized as a problem affecting the quality of health care services and are the principal source of adverse healthcare effects. increased hospital stays, increased costs of healthcare, economic hardship to patients, and their families, and even deaths are some of the negative effects [ ] [ ] [ ] . the amount of nosocomial infections of low-and middle-income countries is higher because of the limited knowledge and utilization of post exposure prophylaxis (pep), limited knowledge of professional risks, low adherence to universal precautions (up), and inaccessibility of personal protective equipment (ppe) [ , , , ] . findings of several epidemiological studies show that hcws, mainly physicians, dentists, laboratories, and nurses are involved in the transmission of nosocomial infections [ ] [ ] [ ] [ ] . it has also been reported that its transmission increases during the performances of medical procedures whenever hcws fail to follow aseptic precautions [ , ] . the world health organization (who), in conjunction with the cdc, gives high attention to the prevention of nosocomial infections as it has developed a practical manual for the prevention of nosocomial infections globally (who, ) . some recommended strategies included in the manual were the use of hand decontamination, personal hygiene, utilization of personal protectives, and proper methods of handling soiled clothing when healthcare workers perform patient care activities. it also recommends methods of preventing environmental contamination including the cleaning of the hospital environment using hot superheated water, sterilizing patient equipment, and preventing the transmission of pathogens like hiv, hepatitis b and c viruses, and tb to the staff [ ] . efficient pre-service and in-service training given by incorporating in the medical education system supported with good monitoring and evaluation methods of hcw practices play a pivotal role in the sustainability of the knowledge, attitude, and practice of universal precautions and infection control [ , ] . this scheme was supported by many studies conducted worldwide. for example, in india, an educational module had effectively elevated the knowledge, attitude, and practice score of hcws from % before the intervention to % thereafter [ ] . in korea, it was also investigated that a group of nurses and medical students who had received education on hais showed high knowledge (p = . ) and performance (p < . ) levels [ ] . similarly, a study at seton hall university in new jersey, usa, indicated that the total score for the knowledge category was % [ ] . likewise, a study in egypt reported that physicians had the best level of knowledge, but the least in practicing general safety measures than others in the preintervention phase. however, they increased their practice score from . to . % after receiving continuing education [ ] . a study in pakistan reported that the knowledge score was . with a median of . the dispenser had the highest knowledge score while the housekeepers had the lowest. knowledge about the mode of transmission of bloodborne pathogen and the work experience alone significantly predicted the use of universal precaution methods in multiple linear regression models [ ] . this principle is also supported by studies conducted in ethiopia. in , a cross-sectional study was conducted in addis ababa on hcws who received training on transmission, vaccination, and diagnosis of hbv to assess their knowledge of risk factors for hbv. the result showed that more than % of the respondents had the knowledge of the modes of transmission and prevention of hbv; . % had a positive attitude towards following infection control guidelines [ ] . similarly, a study conducted in ethiopia at dire dawa university on the medical and health sciences students reported that almost all of the respondents had good knowledge of the transmission, treatment, and prevention of hbv. also, . % of them had good attitudes towards the importance of standard precautions, but . % had poor practices in applying the recommended standard precautions [ ] . in another study, a hospitalbased cross-sectional investigation was conducted among health workers who were taking training about infection and prevention of hospital-acquired infections at debre markos hospital in ethiopia. the results showed that . % of them were found to be knowledgeable; however, only . % of the respondents demonstrated good practice in infection prevention. moreover, respondents with older age, longer work experience, and higher educational status excelled in both knowledge and practice of infection prevention. inservice training, availability of infection prevention supplies, and adherence to infection prevention guidelines were also associated with the practice of infection prevention [ ] . on the other hand, a study conducted at the university of gondar hospital about hand hygiene compliance on study participants showed that only . % had the knowledge about it and . % had received training about hand hygiene compliance, respectively [ ] . hand hygiene is an important means for the control and prevention of nosocomial infection. therefore, the current study intended to determine the impact of the medical education system on the knowledge, attitude, and practice of graduate health sciences students about the prevention and control of nosocomial infections at the university of gondar. an institution-based cross-sectional study was conducted with graduate students from the college of medicine and health sciences at the university of gondar. data collection was made between february and june of . students who attended the regular academic program at the university of gondar, college of medicine and health sciences were the source population. however, only graduate classes of health science students were taken as the study population. before data collection, eleven departments were selected for sampling: health informatics, medical laboratory sciences, health officer, physiotherapy, environmental and occupational health and safety, psychiatry, optometry, midwifery, nursing, pharmacy, and anesthesia. there were graduate students of health sciences in the academic year of . the sample size was determined using a single random sampling method. since no similar study was found in the area, % were taken as a confidence interval. then, the calculated sample size was and by adding a % non-response rate, the final calculated sample size became (fig. ) . the questionnaire was constructed from emergent themes reviewed in the literature and items were derived from the established guidelines set by a task force committee on infection control practices advisory committee [ , ] . the questionnaire includes questions subdivided into four categories: sociodemographic, knowledge, attitude, and practice towards nosocomial infections. knowledge was assessed using questions containing three alternative choices each. the answers from the given alternatives were symbolized as ' ' for poor, ' ' for fair, and ' ' for good. a higher score in the questions concerning nosocomial infections is considered to be good knowledge of nosocomial infections. attitude was measured using questions in which answers for each question were assigned as for 'disagree', for 'neutral', and for 'agree.' higher score achieved was considered as a positive attitude toward standard precaution. moreover, their practice towards the prevention and control of nosocomial infections was assessed using questions with three alternative answers which were assigned as ' ' for poor, ' ' for fair, and ' ' for good (table , table , and table ). bloom's cut-off point was used to determine the level of knowledge, attitude, and practice because the conceptual framework of the present study was based on the taxonomy of educational objectives developed by bloom ( ) . according to bloom's taxonomy ( ), human behaviors are derived from the integration of the cognitive, affective, and psychomotor domains. knowledge, attitudes, and practices could be representatives of the cognitive, affective, and psychomotor domains, respectively. knowledge refers to the factual, conceptual, procedural, and met cognitive thought [ ] . attitude is an internal or covert feeling and emotion; or selective nature of intended behavior which represents the affective domain. practice represents the psychomotor domain which refers to the physical movement, coordination and use of motor or neuromuscular activities [ ] . accordingly, participants' overall knowledge and practice are considered as good if the score is % and above; moderate if the score is between and %; and poor if the score is less than %. similarly, attitude towards nosocomial infection was assessed using questions. responses to questions related to attitude were graded on a -point likert scale with an agreement scale ranging from ' ' for disagree to ' ' for agree [ ] . the overall level of attitude was categorized using bloom's cut-off point: positive if the score was % and above; neutral if the score was - %; and negative if the score was less than %. a simple random sampling method and lottery technique were used to select the respondents and a quantitative method of data collection was employed through a self-administered questionnaire. the quantitative method involves assessment of the impact of medical education on the knowledge, attitude, and practices of graduate students on the prevention and control of nosocomial infection. the data collection instrument format was developed in english by different individuals for its accuracy and desired results. the data collectors used a self-administered questionnaire for graduate students of the health sciences, class of . after receiving a complete response of the questionnaires, data were analyzed using descriptive statistics by ibm spss version . . demographic characteristics are presented in tabular form using descriptive statistics and reported as mean, median, standard deviation, frequency, and percentage as presented in tables. the study was conducted after a written ethical clearance is obtained from the ethical research committee of the school of biomedical laboratory sciences and college of medicine and health sciences. moreover, the consent forms of the participants were completed voluntarily by the study participants themselves. pretest to evaluate the understandability and applicability of the instruments used, pretest data were collected and checked from medical laboratory graduate students using a self-administered questionnaire. self-administered questionnaires were collected from respondents. out of these respondents, % were female while only % of them were above years of age. the proportions of respondents were: ( . %) health informatics, ( . %) medical laboratory sciences, ( . %) health officers, ( . %) physiotherapy, ( . %) environmental and occupational health and safety, ( . %) psychiatry, ( . %) optometry, ( . %) midwifery, ( . %) nursing, ( . %) pharmacy, and ( . %) anesthesia graduated students. only % of the respondents had been trained in infection, prevention out of which % took the training at least a year ago ( table ) . even though % of the respondents stated that they had taken training on nosocomial infections, only . % had good knowledge of nosocomial infections (fig. ) . from the questions administered, the score of knowledge of the respondents ranged from to , with a mean score of . at std. of + . (table ) . as reflected in table , out of the total respondents, . % had good knowledge of the modes of transmission and risk factors for nosocomial infections; . % of the respondents also stated that they were fully aware of hand-washing guidelines; . % knew where and how the contents in biohazard bags or containers are being disposed. it is also shown that table questioner for the assessment of knowledge of graduate health sciences students towards nosocomial infection instruction: to complete this section, please make a tick "✓" on the number corresponds to how you agree with the given alternatives = poor, = fair and = good table questioner for the assessment of practice of graduate health sciences students towards nosocomial infection instruction: to complete this section, please make a tick "✓" on the number corresponds to how you agree with the given statement = poor, = fair, = good . % of them knew that nosocomial infections could be transmitted via fomites, and . % of the respondents understood that healthcare facilities harbor a variety of microorganisms that could be transmitted by healthcare workers. then, . % of respondents were fully aware of safety precautions for the disposal of used medical equipment, and . % of them believed that neutropenic patients like those with diseases of the respiratory system should be kept in private rooms. furthermore, . % of the graduates were knowledgeable in the use of alcohol-based formulations, and . % of them stated that some microorganisms were not totally removed by alcoholbased solutions. the overall practice scores showed that . % have good practice in the prevention and control of nosocomial infection. the score of the practice of the respondents ranged from to , with a mean of . atstd+ . (table ) . respondents reflection to correctly following guidelines for the use of alcohol-based solutions before and after patient care activities were . %; before opening vascular access equipment were . %; between each patient contact were . %; before and after direct contact with patients' intact skin were . %; moving from a contaminated body site to a clean table questioner for the assessment of attitude of graduate health sciences students towards nosocomial infection instruction: to complete this section, please make a tick "✓" on the number corresponds to how you agree with the given statement = disagree, = neutral, = agree body site were . %; before and after drawing or manipulating patient's body fluid samples were . %; before inserting indwelling urinary catheters were . %; and after touching inanimate objects and equipment in the patients' room were . %. of all, . % of the respondents used their computer keyboards with their glove during busy workload. finally, . % of the respondents removed their rings, watches, or bracelets during hand hygiene (table ) . the attitudes of students towards the prevention and control of nosocomial infection were % (fig. ) . of the total respondents, . % believed that nosocomial infections are posing serious negative outcomes but . % responded the opposite while a colleague is noncompliant with the recommended guidelines for patient safety. moreover, . % of the respondents regularly (table ) . nosocomial infection is one of the most important challenges in health institutions. therefore, this study assessed the knowledge, attitude, practice, and associated factors of infection prevention among health science graduate students. the overall score of knowledge ( . %) was lower than the study conducted in the usa ( %) and nepal ( %) [ , ] . similarly, . % had good knowledge of their etiology, modes of transmission, and risk factors of nosocomial infections which were also lower than the study conducted in new jersey, usa ( . %), and nepal ( %). moreover, only . % of the participants knew fomites as transmission factors, which is still lower than the study conducted in the usa ( . %) [ , ] . this might be due to a difference in study participants. in the usa, the study participants were registered nurses who were working in health care institutions and they might develop knowledge from their experiences and/or in-service training. however, in this study, the participants were graduate students of which % never took training on the prevention and control of nosocomial infections. this shows that not all health science students in this college are taking training before their clinical attachments. in the findings of this study, only . % had good practice in the prevention and control of nosocomial infections of which only . % followed the guidelines for the use of alcohol-containing hand sanitizer which is lower than the study conducted in the usa ( %), but higher than a study conducted in china ( %) [ , ] . this may be due to the difference in study participants, the accessibility of alcohol-containing hand sanitizer, and the large difference in course curriculum where infection prevention might not be incorporated in all of the target population. possibly for similar reasons, the attitude of study participants towards the prevention and control of nosocomial infection ( %) was lower than a study carried out in the usa ( . %) and nepal ( . %) [ , ] . a . % positive attitude towards following the recommended guidelines for reducing the transmission of nosocomial infections was lower than a study conducted among health care workers at addis ababa in ethiopia ( . %) [ ] . this might be due to a difference in study participants in addis ababa, where they were registered health care workers who were working in the health institution and they might develop knowledge, attitude, and practice either through their experience or in-service training. however, in this study, the participants were graduate students who reported that % of them never took training on the prevention and control of nosocomial infections before their clinical attachment. generally, more than half of the respondents had poor knowledge, attitude, and practice on nosocomial infection and the application of infection and prevention procedures. the medical education system is the most important and effective tool to bring a better outcome for controlling and preventing nosocomial infections. incorporating the necessary knowledge into the regular course curricula, organizing training modules to medical students before starting clinical attachment, providing different guidelines and standard operating procedures are also helpful in understanding the nature of infections and how, when, and where to prevent and control nosocomial infection. therefore, this study showed that a smaller number of respondents had taken infection prevention training on their regular medical system. consequently, smaller proportions of them had good knowledge, attitude, and practice on the nature of the infection, prevention, and control strategies for nosocomial infections. therefore, to improve the level of knowledge, attitude, and practice of students towards nosocomial infections, strengthening the medical education system through relevant seminars including short and long-term training is essential. at the same time, the availability of infection prevention guidelines, standard operating procedures, and personal protective equipment like alcohol-based solutions in health institutions are important. departments, schools, and college administrative officers should work together to facilitate infection prevention training programs for all health science students before starting their clinical attachments. the ministry of health and ministry of education should work to enforce the universities to incorporate infection prevention knowledge into the course curricula for all health science students. all health care institutions must be prepared to give vaccination of common hospital-acquired diseases by making available infection prevention materials and standard operational author's contributions te: conception of a research idea, study design, data analysis, interpretation, and manuscript write up. the author(s) read and approved the final manuscript. no one was responsible for the funding of this research. all data generated or analyzed during this study are included in this article. ethics approval and consent to participate ethical clearance was obtained from the research and ethical review committee of the school of biomedical and laboratory sciences, college of medicine and health sciences, university of gondar. moreover, written consent was taken from each participant after they understood the purpose of the study. all the subjects' data were kept in full confidentiality and were not being disclosed to an unauthorized person. not applicable. extended hospital stay days, mortality and increased cost of healthcare) nurse or physician) is non-compliant with the recommended guidelines for patient safety in my opinion, healthcare workers should be sanctioned for non-compliance with protocols for reducing transmission of nosocomial infections (for example, yearly assessment, and denied promotion) in my opinion, healthcare workers should be rewarded (for example, given plaques, certificate) for compliance with protocols aimed at reducing transmission of nosocomial the number of graduate health science students; % indicates percentage engda prevention of hospital acquired infections: a practical guide is us health really the best in the world? decreasing urinary tract infections through staff development, outcomes, and nursing process statistical abstract of the united states guidelines for hand hygiene in health care settings an outbreak of hepatitis c virus infections among patients at a hematology/oncology clinic new jersey: pearson education cluster of cases of severe acute respiratory syndrome among toronto healthcare workers after implementation of infection control precautions: a case series use of influenza a (h n ) monovalent vaccine: recommendations of the advisory committee on immunization practices (acip) the global burden of disease attributable to contaminated injections given in health care settings guidelines for preventing the transmission of mycobacterium tuberculosis in health-care settings training self-assessment and task-selection skills: a cognitive approach to improving self-regulated learning student self-assessment: the key to stronger student motivation and higher achievement. educ horizons impact of education on knowledge, attitudes and practices among various categories of health care workers on nosocomial infections knowledge and performance of the universal precautions by nursing and medical students in korea exploring knowledge, attitudes and practices of registered nurses regarding the spread of nosocomial infections. seton hall university dissertations and theses (etds): paper poor knowledge predictor of nonadherence to universal precautions for blood borne pathogens at first level care facilities in pakistan assessment of knowledge, attitudes and practices toward prevention of hepatitis b virus infection among students of medicine and health sciences in northwest ethiopia knowledge, practice and associated factors of infection prevention among healthcare workers in debre markos referral hospital, northwest ethiopia. bmc hand hygiene compliance and associated factors among health care providers in gondar university hospital attitude and practice of nursing students regarding hand hygiene in the western region of nepal taxonomy education attitude and practice of nursing students on hospital acquired infections in western region of nepal the author declares that there is no competing interest.received: june accepted: october key: cord- -uzgya k authors: strömmer, sofia; barrett, millie; woods-townsend, kathryn; baird, janis; farrell, david; lord, joanne; morrison, leanne; shaw, sarah; vogel, christina; lawrence, wendy; lovelock, donna; bagust, lisa; varkonyi-sepp, judit; coakley, patsy; campbell, lyall; anderson, ross; horsfall, tina; kalita, neelam; onyimadu, olu; clarke, john; cooper, cyrus; chase, debbie; lambrick, danielle; little, paul; hanson, mark; godfrey, keith; inskip, hazel; barker, mary title: engaging adolescents in changing behaviour (each-b): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity date: - - journal: trials doi: . /s - - -w sha: doc_id: cord_uid: uzgya k background: poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. there is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. improving adolescents’ health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. building on lifelab—an existing, purpose-built educational facility at the university of southampton—we have developed a multi-component intervention for secondary school students called engaging adolescents in changing behaviour (each-b) that aims to motivate and support adolescents to eat better and be more physically active. methods: a cluster randomised controlled trial is being conducted to evaluate the effectiveness of the each-b intervention. the primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (pa) levels, both assessed at baseline and at -month follow-up. the each-b intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the lifelab educational module comprising in-school teaching of nine science lessons linked to the english national curriculum and a practical day visit to the lifelab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. both the taught module and the lifelab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and pa, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. the each-b research trial aims to recruit approximately secondary school students aged – years from schools (the clusters) from hampshire and neighbouring counties. participating schools will be randomised to either the control or intervention arm. the intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. the schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. an economic model will be developed to assess the cost-effectiveness of the each-b intervention compared with usual schooling. discussion: adolescents’ health needs are often ignored and they can be difficult to engage in behaviour change. building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children. trial registration: isrctn . registered on august . each-b is a cluster randomised controlled trial, funded by the national institute for health research (rp-pg- - ). the nhs long term plan sets out a prevention agenda in the uk aimed at reducing the risk of developing noncommunicable diseases (ncds) such as cardiovascular conditions and type diabetes [ ] . insufficient exercise and poor dietary quality are common and are linked to increased risk of ncds. ncds place a heavy burden on society, hospitals and community health services, costing the nhs £ billion a year [ ] . uk adolescents have poorer diets than other age groups, and fewer than % meet physical activity guidelines [ , ] . intervening during adolescence to support better health habits can bring a triple benefit: to the immediate health and wellbeing of the young person, to their own health in adulthood and to the health of the next generation [ ] [ ] [ ] [ ] [ ] . it is well-established that improving the dietary quality and nutritional status of both young women and young men before conception improves pregnancy and birth outcomes and therefore the long-term health of the offspring [ ] [ ] [ ] . it has also been suggested that adolescence is a critical period during which optimal nutrition could mitigate the effects of poor fetal and infant nutrition [ , ] . as a critical period of both physical and social development, adolescence is the time during which the physiological, mental and behavioural foundations of long-term health are consolidated. peak muscle and bone mass as well as cardio-respiratory fitness are reached during adolescence, and these physiological processes are both nutritionally sensitive and predictive of later health [ ] [ ] [ ] . in addition, widespread brain re-modelling during adolescence leads to a large increase in cognitive ability [ ] . adolescence is also a key time for the development of executive function and the capacity to make independent choices, follow them through and achieve goals, as well as the ability to form healthy social networks. lifelong behaviour patterns are established in adolescence, including choices about diet and physical activity (pa) [ ] . adolescence is a challenging time to intervene to improve health behaviours for both psychological and physiological reasons. adolescents find it difficult to engage with the long-term consequences of their lifestyle choices. developmental changes in brain structure leave them sensitive to emotional and social influences and to prioritising the immediate over the long-term; brain pathways involved in decision-making processes do not mature fully until early adulthood [ , ] . systematic reviews suggest that motivated and engaged adolescents can improve their health behaviours [ ] . however, little is known about precisely how to motivate and engage adolescents in sustaining positive changes long term [ , ] . the latest research evidence strongly indicates that successful interventions with adolescents are as follows: (i) multi-component, (ii) involve schools, (iii) engage and motivate adolescents to change their health behaviours and (iv) involve social support from friends and parents [ , ] . in addition, digital platforms show potential as complementary features in complex interventions targeting health behaviour change and are particularly relevant to this age group. approximately % of - year olds owned smartphones in , and % spent an average of h a week online [ ] . key strategies for effective engagement with digital interventions are recognised to include co-designing interventions with adolescents, the personalisation of interventions and connectivity to peers and the user's wider social networks [ ] . it is increasingly recognised that interventions need to facilitate collaboration between different agencies such as schools, community and parent groups and not rely on one setting, such as the school or family. interventions to improve adolescents' diet and pa have been implemented with varying success; effective engagement with, and motivation of, adolescents remains a pertinent issue. gender-specific issues should not be overlooked, and positive effects post-intervention may not be apparent in the short-term, making medium and longer-term measures important [ , , ] . many interventions favour combining health and nutrition education with behavioural skills training, even though evidence suggests that adolescents are not ignorant about the health implications of their food choices and pa habits, nor are they motivated by health in the distant future [ , ] . recent research has suggested that interventions designed to support adolescent health may be more engaging and successful if they align health agendas with adolescents' own values and priorities [ , ] . each-b is designed using a person-based approach [ ] [ ] [ ] with extensive co-creation to maximise alignment with adolescents' own values in order to make the intervention both engaging and effective. the views and input of parents and adolescents in the age range of each-b's target population have been continually sought and incorporated into the trial design through extensive engagement work with local schools, youth groups, and through lifelab's young ambassadors scheme. in addition, two advisory groups have been set up to ensure the intervention design and delivery are acceptable to parents of young teenagers and to the young people themselves. a number of 'game jams' involving approximately adolescents have been run throughout the development phase, in order to ensure the app reflects the values and priorities of the intended user group [ ] . aligning an intervention design with adolescent values and using fun, engaging methods of delivering behaviour change support as part of a multi-component, school-based intervention improves diet and pa habits of secondary school students. the aim of this cluster randomised controlled trial is to evaluate whether each-b, a complex intervention designed to engage, motivate and support adolescents aged - years, improves their dietary quality and pa habits. each-b is a cluster randomised controlled trial using a : allocation within a superiority framework. the intervention consists of three-components: ( ) face-to-face support from teachers trained in skills to support behaviour change, ( ) engagement in the lifelab school-based education programme and ( ) a digital intervention with games as well as peer-and parent-support features. we propose to evaluate each-b through a cluster randomised controlled trial. we plan to recruit boys and girls of middle academic ability in year (aged - years) from state secondary schools/academies (approximately students) to take part in the trial. year is the second year of senior school in the uk and was chosen to take part in each-b in consultation with schools for two key reasons: schools are better able to deliver the intervention at this time, before students start their gcse curriculums in year and timetabling becomes more difficult; adolescents in year often have increased levels of independence in terms of food choices whilst travelling to and from school alone or with friends. schools in hampshire, uk, and the surrounding counties will be eligible to take part. hampshire is a large county (pop. . million) in the south of england with a wide range of socioeconomic profiles. some rural areas of hampshire are affluent, but the two major cities southampton and portsmouth are in the most deprived quintile of local authorities in the uk [ ] . schools will be recruited from both rural and urban settings in order to reflect the diversity of the population (see the 'randomisation/blind ing' section for more on randomisation procedures). each school will be randomly allocated to either 'control' or 'intervention' status. of the schools recruited, will therefore be intervention schools where two classes of year students will complete the lifelab module, be offered support from teachers trained in skills to support health behaviour change and receive the digital intervention. the other schools will form the control group and will receive normal schooling. all state secondary schools and academies in hampshire and surrounding areas are eligible to take part in the each-b intervention trial. independent and selective schools including special schools and single-gender schools are excluded from taking part because by nature of being selective their inclusion could bias the study findings. lifelab's young ambassadors scheme is a scheme whereby young people who visit lifelab with their school can sign up to be a young ambassador in order to support lifelab's aims and objectives by taking part in special activities including being consulted on new ideas as they are developed and worked up by the lifelab team. in late , a successful pilot trial was run with students from six schools in the southampton area, to test and modify the intervention. the intervention comprises: i) professional development for teachers including training in communication skills to support health behaviour change, known as 'healthy conversation skills' (hcs), explained in detail below ii) lifelab educational module comprising in-school teaching of nine science lessons linked to the english national curriculum and a hands-on practical day visit to lifelab, held part way through the module iii) a personalised digital intervention (the 'app') with social support and game features the each-b intervention includes professional development (pd) for all teachers involved in delivering the life-lab educational module. the -day pd training course takes place at lifelab and focuses on science education relevant to the implementation of the nine lessons in school. it offers access to online support materials which describe the underpinning science. teachers are trained in hcs [ , ] to engage with their students in making plans to improve their diet and/or activity levels via a personal 'lifelab pledge'. teachers are trained how to support their students to keep their pledges, and how to use the digital intervention, through asking open questions and listening rather than telling. an additional hcs training session will be offered to the whole staff body in intervention schools to enhance the opportunity for adolescents to be supported at school to improve their health behaviour. hcs training was developed in southampton to provide communication skills to support behaviour change. these skills were designed in the first instance for health and social care practitioners to use with their patients and clients, but have since been adapted to the training of teachers to enable them to better support behaviour change in their students. while health promotion is not seen as a core requirement of a teacher's role, we have seen high levels of engagement from teachers throughout the development work and each-b pilot trial. it is widely acknowledged both in the scientific literature and by schools that diet and pa behaviours are significant factors in both academic performance and student wellbeing and there is growing evidence that health and health behaviours have measurable consequences for attainment [ ] . being more physically active at age is associated with higher attainment at gcse, while being obese at age is associated with lower attainment [ , ] . children from more disadvantaged backgrounds are more likely to be overweight/obese, have poorer diets and be less physically active. being overweight/obese can reduce children's self-esteem, which may lead to lower educational attainment and behavioural problems [ ] . therefore, schools and teachers are keen to learn skills that enable them to support students to eat well and be more active. the use of hcs encourages people to reflect on behaviours that they would like to change, in many cases making the unconscious, habitual behaviours conscious and therefore amenable to deliberate change. hcs trains people to use five key skills: ( ) creating opportunities for having healthy conversations; ( ) asking open 'discovery' questions that lead people to explore and find their own solutions; ( ) listening more than talking and so empowering people to identify and take control of their own behaviour change; ( ) reflecting on practice in order to be more effective; and ( ) supporting goalsetting using smarter action planning, providing people with a sense of change and progress. these skills were originally developed in collaboration with local health service commissioners in southampton, whose needs-assessment found that their healthcare providers lacked confidence to support clients to improve their diets and lifestyles [ ] . hcs training recognises that skills to support behaviour change need to go beyond education and instead empower individuals to take control of their health behaviours and to problem-solve. as with motivational interviewing, the training offers an approach to supporting behaviour change that is based on the understanding that giving people information is insufficient to change their behaviour; they must also be motivated to change and have the tools to implement that change. hcs training is philosophically underpinned by bandura's social cognitive theory of the socio-environmental and personal determinants of health [ ] . self-efficacy is a central construct in this theory and describes an individual's belief that he or she is capable of carrying out a specific behaviour, which implies that he or she also has the knowledge and skills to do so. hcs are designed to increase self-efficacy through empowering problem-solving, and employ behaviour change techniques [ , ] intended to support small changes in behaviour, leading to acquisition of mastery skills which bandura proposes as a means of raising self-efficacy. training in hcs is designed to increase the self-efficacy and hence build the capacity of practitioners and clients and, in doing so, change the ethos of those practitioners and their organisations to one that empowers change. the each-b intervention is designed to operate both at the level of individual behaviour change and at the level of changing the culture of schools to trigger automatic as well as reflective processes underlying behaviour change [ , , , ] . the lifelab educational module aims to engage adolescents with the knowledge and understanding needed to enable them to make appropriate health choices-their health literacy-and to motivate them to change their dietary and pa behaviours. the theme of the module is 'me, my health & my children's health', and it is delivered in an interactive and highly engaging format which sets scientific knowledge into a relevant and accessible context for this age group [ ] . the educational module is designed to be delivered as four pre-and five post-lifelab visit lessons delivered in science classes during the school day. the materials used in the educational module are explicitly linked to the english national curriculum, embed the messages of the lifelab visit and have been updated specifically for the each-b trial. for example, an additional lesson focusing on the influences of the food environment on healthy lifestyle choices has been added, in order to encourage the adolescents to critically analyse their own food environments and the influence these may have on their dietary behaviours. health messages in the module are linked to both the hands-on practical activities the students will carry-out on the day visit to lifelab and to the school-based activities. this approach is intended to ensure that the adolescents understand the long-term implications of their current diet and pa on their future health, their children's health and on the risk of ncds for both. halfway through the lifelab educational module in school, the students and their science teacher have a day visit to the purpose-built laboratory facility, based in southampton general hospital. the visit combines a mixture of hands-on practical work, reflection on lifestyle choices and learning about the science behind health messages. activities include: experiencing a variety of ways to measure health including assessing carotid artery blood flow and structure using ultrasound, measuring body composition, performing lung function tests, training in cpr and testing grip strength and flexibility extracting their own dna and carrying out gel electrophoresis experiments that illustrate how a healthy diet can induce epigenetic changes that alter dna structure and are passed from parents to offspring, with implications for cardiovascular and lifelong health for themselves and their children small group discussion sessions with scientists based at the hospital, to introduce students to the range of career options in scientific disciplines. at the end of the lifelab visit, and with support from lifelab staff, students are encouraged to make a 'pledge' about a positive change for their own health. students also download the each-b app onto their personal devices during the day (see below). the digital intervention will be in the form of a mobile phone application (app) with game features. it has been developed using a person-based approach to intervention development, combined with user-centred design principles for digital game design and a participatory design process. the design of the game is underpinned by self-determination theory and employs a range of behaviour change techniques [ , , ] . during the lifelab visit, students will be asked to download the app onto their personal mobile devices (android or ios) and log in. any student without a personal device will be given instructions for downloading the app at home via a shared family device. the app will involve creating a character and choosing games, quizzes and challenges to complete. players can choose challenges and none are compulsory. the app will allow players to connect with each other if they wish. parents/carers of students in the intervention will also be offered a companion app to help them support their adolescent in making healthy lifestyle choices. the parent app includes information about the different elements of the app developed for the young people taking part in the intervention. it also contains ideas, suggestions and prompts as to how parent and adolescent can join forces to improve food choices and activity levels for the whole family. all outcomes will be measured twice, once at baseline and again months later at follow-up. the trial has co-primary outcomes for dietary quality and pa. dietary quality will be assessed by a -item food frequency questionnaire (ffq). this ffq has been developed specifically for use with adolescents using data for boys and girls aged - years who took part in the national diet and nutrition survey. principal component analysis was applied to these data in order to identify indicator foods which best describe better and poorer dietary quality of uk adolescents. this ffq has shown good comparison with important nutritional biomarkers including -hydroxy vitamin d, total carotenoids, serum folate and vitamin c. using geneactiv™ accelerometers pa will be assessed as minutes of daily low, moderate and vigorous physical activity (lmvpa), also described as total pa [ ] . at baseline and again at the -month follow-up, geneactivs will be worn for days and the output data will be averaged over this period, or the maximum period of valid data. secondary outcomes for dietary quality are as follows: usual portions in the past month of water, sugar sweetened beverages (ssbs), chips and crisps and usual portions of fruit and vegetables consumed in a typical day. the number of portions of fruit and vegetables are analysed separately to estimate daily fruit and vegetable consumption for each adolescent [ ] . categories of pa will also be assessed as secondary outcomes, namely average acceleration, intensity gradient, sedentary time, light pa, light to moderate pa, moderate to vigorous pa, lmvpa -min, lmpa -min and mvpa -min. the categories of ' -min' restricts to activity that has a minimum of -min bout duration. all pa outcomes (primary and secondary) will be analysed separately for activity at the following times: weekdays, weekends, during school hours and during out-of-school hours. additional secondary outcomes are as follows: bmi zscores, with and without adjustment for pubertal status as indicated by standing height, sitting height and weight [ ] ; self-reported frequency of pa from a modified version of the youth physical activity questionnaire (ypaq) validated for use in - year olds [ ] ; behavioural self-regulation and self-efficacy for healthy eating and pa; and quality of life and wellbeing measured by two age-appropriate tools: the child health utility d (chu d) [ ] and the cantril ladder [ ] . behavioural regulation and self-efficacy for pa will be assessed by the behavioural regulation for exercise questionnaire [ ] and the pa section of the self-efficacy for healthy eating and physical activity measure (se-hepa) [ ] . behavioural regulation and self-efficacy for diet will be assessed using the recently developed confidence and behavioural autonomy (cba) scale. this is age-specific and has been validated against the healthy eating scales of the se-hepa and the treatment self-regulation questionnaire (tsrq) [ ] . a schematic schedule of enrolment, interventions and assessments is shown in fig. . unpublished analysis of earlier data from lifelab indicates an intra-school (class) correlation coefficient of . . forty-six schools each sending two classes amounting to approximately students from each school and students in total will provide % power at a . % significance level (accounting for two primary outcomes) to detect a . sd difference in diet quality score or minutes of total pa in intervention and control schools. comparable effect sizes have been considered in other health interventions as meaningful in terms of change in health behaviours, and our level of . sds falls in the mid-range of effect sizes reported in a meta-synthesis of meta-analyses of behaviour change interventions in the general population [ ] . we will recruit two year classes ( - years) from schools allowing for drop-out, though in previous lifelab studies only one school has ever dropped out. to minimise bias from loss of students to follow-up, we will request class lists for each participating class, so that missing participants at each stage of the follow-up can be identified and included in secondary analyses and process evaluation assessing uptake of the intervention. recruitment for each-b began in september and will run for years, with data collection taking place at schools at baseline and again months later. the life-lab team has worked with schools for many years and good systems for recruiting schools have been developed, so recruitment difficulties are not anticipated. we appreciate that control schools will not want to miss out on the intervention and therefore all control schools will be offered a visit to lifelab the following year. the schedule of enrolment for the trial is shown in fig. . schools will be recruited through a range of methods including presentations at relevant local meetings such as the secondary heads of science forum meetings, and letters sent to head teachers and heads of science of eligible schools in the recruitment catchment area. the recruitment pack for each-b includes a cover letter and information sheet for the school, offering basic information about the trial and explaining how the experience will differ for control and intervention schools. schools are then offered a meeting with the each-b research team at which further details are discussed and any questions answered. this meeting will take place with the head of science and a member of the senior leadership team at the school, at a time to suit them. it is also an opportunity for the research team and the school staff to establish how the intervention will run in the school, if it is allocated to the intervention arm, as each school operates differently in terms of timetabling science classes. schools will be asked to allocate two middle ability year classes to participate in the trial totalling approximately students. the teaching programme is designed for students in this age group and of all ability levels; there are no exclusion criteria for students. for students who may require more input (those who have english as a second language, for example), we provide support for schools in planning delivery of the module. specifics are discussed at the teachers' pd day. schools will already have in place provision for these students, and so it is a matter of ensuring that the lifelab materials are accessible by all participating students. following the meeting at school, the head teacher is asked to sign a consent form confirming they wish to take part, that they understand the trial procedures and to name the two classes that will participate. after signed agreement from the schools has been obtained and the classes taking part have been identified, schools will be randomised to receive usual schooling (control) or the each-b intervention (lifelab programme, hcs training for teachers, and access to the digital intervention) (see fig. ). we will use a minimisation procedure developed by the southampton clinical trials unit (tenalea), which aims to achieve a balance of schools in the two arms based on the following three criteria: -the proportion of students in the school receiving free school meals (cut-off > %); -the proportion of students in the school achieving l gcse (equivalent to a high 'c' grade) in english and maths (cut-off > %); -whether or not the school already participated in the full lifelab programme in the previous years. the randomisation is administered through a webbased secure system to which the each-b team submit the details of schools who have consented to participate. these are sequentially numbered and the allocation to intervention or control is then reported to the investigators. blinding from this point onwards is not possible except of the statisticians who will be analysing the data. many schools we recruit will have previously been involved in lifelab. contamination of the intervention effect is unlikely to occur as the year students taking part in each-b will not have visited lifelab before, and except for siblings, they will generally have limited contact with older children in the school. it will not be possible to blind schools and their students to their allocation due to the nature of the intervention. primary and secondary outcome data will be collected at baseline and follow-up visits by research staff to schools, conducted during class time. standing and sitting height and weight will be collected by trained research nurses from the clinical research facility at the southampton nihr biomedical research centre (sbrc). these measures will be used to derive body mass index z-scores and biological maturity [ ] . all researchers and research nurses working on the each-b trial will be trained in trial-specific procedures and be required to complete appropriate safeguarding and eating-disorder training. questionnaire data will be collected through participant completion of questionnaires on ipads during the baseline and follow-up visits to schools. the class will be divided into small groups of - students working with one member of the research team who will act as a facilitator. before students begin completing the questionnaires, the facilitator will use a trial-specific standard operating procedure to explain key points about the questionnaires and will remain with the group throughout the session to answer any questions that might arise. geneactiv™ accelerometers will be distributed to participants by trained research staff during the data collection sessions at both time points. the devices will be programmed to automatically start measuring at midnight on the first day of data collection and stop measuring precisely days later, in order to capture both weekend and weekday activity. a sampling frequency of hz will be used. participants will be asked to keep the device on their non-dominant wrist for seven full days, preferably without taking it off at any point. seven days after the baseline data collection visit, schools will be asked to return the geneactivs to the research team via courier or another secure method. after data collection visits to schools, all data will be downloaded from the ipads via a secure sockets layer (ssl) that encrypts the data before sending it and storing it in the database. the database itself is kept on a university server. all questionnaire data will be kept in accordance with general data protection regulations (gdpr), university of southampton data protection policy and in accordance with the protocols of the mrc lifecourse epidemiology unit leu). the data will be stored in password-protected computers by the research team and only accessible by them. data will be stored in access databases and managed with support from the data management staff of the mrc leu, who have extensive data management expertise and manage data from more than studies. after the trial is complete, anonymised data will be available to other researchers under our data sharing protocols. identifying information will be collected about participants, purely for the purposes of matching baseline and follow-up questionnaires. all identifying information will be stripped from the rest of the data after linkage is complete and will be stored separately. it will only be kept in case a further follow-up is planned. data will be analysed using stata, spss and mplus. the primary analyses will be according to the intention-totreat principle, comparing dietary quality and pa levels in the intervention and control groups using mixed effects linear regression to account for clustering within schools. the main analysis will compare these outcomes at baseline and at months follow-up. although randomised at the level of schools using a minimisation algorithm, there may still be disparities between the intervention and control participants at baseline. these will be assessed prior to analysis and relevant confounders will be incorporated in the models; factors to be considered include gender, exact age at recruitment and household area of deprivation using the income of deprivation affecting children index (idaci) score [ ] . adjustment for baseline dietary quality and pa levels will be included in the relevant models to allow an assessment of change from baseline. sensitivity analyses will examine effects of missing data, and multiple imputation will be used where appropriate, accounting for the clustered nature of the data. comparisons for secondary outcomes will also be modelled using mixed effects linear regression, with the use of binary models for binary outcome variables. mixed effect logistic regression will be used for rare outcomes and mixed effect binary regression (or poisson regression with robust variance if the binary regression models fail to converge) will be used for outcomes that occur in more than % of students. we will then conduct a mediation analysis to examine the role of these secondary factors in mediating the effect of the intervention on primary outcomes. the main analyses will be conducted using the latest available version of stata. planned subgroup analyses will focus on whether there are different effects for boys and girls, differing ethnicities, seasonal variation, idaci score and estimated biological maturity in outcomes. we will also determine the effect of each-b on outcomes for those who fully engage with the digital intervention (per protocol analysis) and assess uptake of the digital intervention by gender, ethnicity and idaci score. complier average causal effect (cace) modelling techniques will be used to examine factors that predict engagement with intervention components and to examine intervention effects specifically for students who engaged with those components. as this is a cluster randomised controlled trial, many of the assumptions underlying this method are unlikely to be valid, most obviously the independence of the participants [ ] . these assumptions will be assessed and methods of analysis developed appropriately. the cace analysis will be performed using mplus. data monitoring will be the responsibility of the trial team at the mrc leu. the steering committee will receive regular data reports as part of their bi-annual meetings. due to the low risk nature of the trial, a separate data monitoring committee is not deemed necessary. we are not expecting the trial to give rise to any adverse events or harms. however, a risk assessment was completed and submitted as part of the ethical approval process. all staff involved in visiting schools have the enhanced level of dbs to work with children, are trained in safeguarding and awareness of eating disorders and have basic levels of awareness about dealing with someone who may become anxious for any reason during a data collection visit. using the mrc guidance on process evaluation of complex interventions [ ] , focusing on the programme logic model, we will use mixed-methods to examine (i) implementation, (ii) context and (iii) mechanisms of impact of the each-b intervention. i) implementation: we will examine how intervention delivery is achieved and what is delivered (fidelity, dose, adaptations and reach) by, for example, monitoring downloads of the digital intervention on lifelab day as a proportion of those eligible, frequency of access to the digital intervention, as well as conducting structured, qualitative observations of teacher/student interactions, and teacher/student interviews. ii) context: we will assess context at school level by interviewing relevant staff about other activities and factors that may affect how the intervention was implemented and how it worked. the wider policy context will also be assessed at local and national levels by considering relevant healthy living initiatives or campaigns and their potential influence. iii) mechanisms of impact: we will conduct interviews with students, teachers and parents to explore their experiences of and engagement with the intervention as a whole and use in-app telemetry to explore usage of the digital intervention. some interviews will be carried-out with specific subgroups of students to ensure that the intervention is not stigmatising. analysis of the qualitative data collected as part of the process evaluation will be conducted with a view to achieving a comprehensive understanding of the way in which an intervention like each-b is implemented and how that relates to the outcomes. thematic analyses of all qualitative data from the process evaluation will be undertaken. structured, qualitative observations of teacher/student interactions and interviews with students, teachers and parents to explore their experiences of and engagement with the intervention will be analysed using various forms of content analysis. for observations of teacher/student interactions, structured record forms will be designed to monitor use of hcs. interviews will be audio-recorded, transcribed verbatim and analysed using inductive thematic analysis and a standard methodology [ ] . initial codes will be discussed between coders to reach agreement on themes, and then discussed with the wider research team and ppi panels. broad themes will then be broken down to identify commonly expressed themes and unusual cases. approximately % of the data will be coded by two team members to check that the coding scheme is identifying all the themes and concepts and that there is a shared understanding of what they are. findings will be used to assist with interpretation of the trial outcomes and to illuminate mechanisms through which the intervention has its effect. a model will be developed to estimate the costeffectiveness of each-b compared to usual schooling. the model will extrapolate short-term observed effects on diet, pa and quality of life (chu d) to estimate future health impacts and societal costs. there are many risks associated with poor diet and low pa over the life course, including increased incidence of a range of ncds and adverse social, economic and well-being outcomes. we will focus on four key risks for which there is good evidence of a short to medium-term impact: incidence of type diabetes, mental health, low birth weight and future loss of earnings [ ] . health outcomes will be quantified using quality-adjusted life years (qalys), including direct effects of diet and pa on quality of life (chu d), as well as losses associated with type diabetes, depression and low-birth weight pregnancies. costs will be estimated from a societal perspective, including costs to schools, local authorities and the nhs and loss of earnings for individuals. costs and qalys will be estimated over a time horizon of years in the base case, discounted at uk recommended annual rates [ ] . a range of sensitivity and scenario analyses will be conducted to assess uncertainty of the model predictions. this will include alternative assumptions about the persistence of observed effects on diet quality, pa and quality of life from the trial. this trial will estimate the effectiveness of a complex intervention to improve diet and pa in adolescents, designed to have reach and affordability. if it proves effective, the intervention could be rapidly and inexpensively disseminated to all secondary school students attending lifelab from across the wessex region. potential for the intervention to be introduced widely across the uk will be explored. some elements of the intervention will be easier to translate than others. in areas where there is already an educational intervention providing initial engagement for adolescents in thinking about their health, educators could be trained in communication skills to support behaviour change. the supplementary digital intervention is low-cost and sustainable. if successful in supporting behaviour change, the intervention has potential for both immediate impact on adolescents' health and well-being and for improving the health of the nation for generations to come. the intervention is designed to deliver outcomes aligned to the local authority's sustainability and transformation plan. as such, it represents an attempt to meet the need to provide preventive methods that can easily be up-scaled and that deliver technological solutions for major health issues. trial findings that will have wide application and impact include improvements in understanding how best to intervene with maximal effectiveness and cost-effectiveness to improve adolescent health behaviours, and to engage, and sustain the engagement, of adolescents. sub-group analyses of data will allow tailoring of the intervention to specific groups, e.g. the most disadvantaged, hardest to reach, or boys as distinct from girls. the programme provides information about the value of, and best practice in, co-creation of initiatives with adolescents and our understanding of mechanisms of creating change with adolescents. recruitment for the rct initiated in september and was due to be completed by june . the trial was halted in march due to the closure of schools in response to the covid- global pandemic. the trial team plans to restart the trial in late autumn . the trial protocol is version date august . the study has been registered on the isrctn database (isrctn , registered august ). the research sponsor is the university hospital southampton nhs foundation trust. the each-b research management team (comprising sts, meb, jvs and hmi) and research theme leads (jb, kwt and the management team) meet regularly to monitor the trial, while the remaining co-applicants and programme steering committee provide oversight through bi-annual meetings. we do not anticipate any protocol amendments, but may have to make changes as a consequence of the covid- pandemic. in the instance of a protocol amendment being required, we would discuss this with the programme steering committee, the funder, the sponsor and ethics committee and any participants affected. the main output from this research will be a fully developed, replicable intervention to improve adolescents' dietary quality and pa levels. we will determine the success of co-creation processes with adolescents, short-, medium-and long-term health benefits from intervening in adolescence, intervention cost-effectiveness, including reach/affordability and feasibility of rapid/inexpensive roll-out into routine practice in schools. in line with funder requirements, at the end of the trial after all statistical analyses are completed, we plan to grant public access to the full trial protocol, the anonymised dataset and statistical code used. dissemination pathways include close collaboration with stakeholders, including young people, feedback of findings to teachers and students, interactive workshops with stakeholders; conference presentations and a series of papers in open access peer-reviewed journals; links with professional societies and policy-makers; and regular press releases. all participants' data will be stored anonymously following the university of southampton guidelines. confidentiality and linked anonymity will be assured. information will not be reported in a way that would allow an individual participant to be identified. participants will only be known by id number when the data are reported. participants' identifying information will be stored separately from the data collected, but need to be kept to ensure linkage between the baseline and follow-up data. all interview data will be kept in accordance with the data protection law (including gdpr) and university of southampton and uk medical research council policies. data will be stored on password-protected computers by the research team and only accessible to them through the data manager. ancillary and post-trial care there are no expected adverse events or harms associated with the trial. no specific post-trial care is planned, but in an event where a participant was in any way adversely affected, the study team would work closely with the school and parents of the participant to ensure appropriate support is offered. all authors took part in the design of the study. meb, hmi, kwt, sts, scs and mb carried out pilot work and were involved in the conception, development and delivery of the programme of work. meb and hmi are principal investigators and together have overall responsibility for the each-b trial and wrote the protocol for the study. lb, dml and kwt were involved in the design, development and delivery of the teaching programme of work, including the pd programme for teachers, and wtl was involved in the design and delivery of the pd programme for participating teachers and leads on the hcs components and evaluation. meb, hmi and jb were involved in the design of the cluster randomised trial and concurrent process evaluation. meb, sts, scs, hmi and cv were involved in the design and validation of the research questionnaires. hmi is the statistician on each-b. pc, mb, hmi and sts manage the data for this study. jc, cc, dc, pl, mh and kg are study collaborators and were involved in the conception and development of the study. dl has advised on the design and development of the physical activity measures and is responsible for the analysis of the physical activity data. jl, nk and oo are responsible for the health economic modelling and cost-effectiveness analysis of the interventions developed in this programme. all authors have contributed to the manuscript and approved the final submitted version. this research is funded by uk nihr programme grants for applied research (rp-pg- - ). the views expressed are those of the authors and not necessarily those of the nihr or the department of health and social care. researchers working on this trial are also supported by the following funding sources: uk medical research council (mc_uu_ / ), nihr southampton biomedical research centre, wessex heartbeat and public health england. lifelab has also received research funding from the british heart foundation, the wellcome trust, cancer research uk, research councils uk, the bupa foundation, the primary science teaching trust (formerly the astra zeneca science teaching trust) and the epsrc (via the uos pathways to impact funding scheme). study sponsor and funder have had no role in study design and will have no role in collection, management, analysis or interpretation of data; the writing up of a final report; and the decision to submit papers for publication, and they will not have ultimate authority over any of these activities. data sharing is not applicable to this article as it is a protocol of an ongoing study and no data is reported. all anonymised datasets from the study will be deposited in a publicly available repository after the trial has ended. ethics approval and consent to participate full ethical approval was granted on july from the university of southampton's faculty of medicine ethics committee (ethics id ). once the school has agreed to participate, the head teacher has signed the consent form, and the randomisation process is complete, the appropriate trial documents for parents and students are provided for the schools to disseminate. two versions of the letter for parents and the participant information sheets have been produced: one for intervention schools and one for control schools. in both cases, parents and students are provided with contact details of the research team in case they have questions about taking part in the research trial. for both intervention and control schools, consent will be opt-in and collected by the schools prior to any research data being collected. in keeping with good practice, the consent form for intervention schools requires parents to initial boxes for each part of the intervention to ensure they understand and consent to each part separately. in all cases, student assent is also required and it is made clear that taking part is voluntary and a student or parent can withdraw their assent/consent at any time without giving a reason. the consent documents are collected by the study team at the baseline visit to schools and are thereafter stored securely at the mrc leu. no details, images or videos relating to an individual person are included. model consent forms will be provided on request. competing interests kg has received reimbursement for speaking at conferences sponsored by nutrition companies and is part of an academic consortium that has received research funding from abbott nutrition, nestec and danone. the university of southampton has received an unrestricted donation from danone nutricia to support lifelab's work with schools. wendy lawrence has received funding from danone nutritia early life nutrition for training and presentations. cc has received lecture fees and honoraria from amgen, danone, eli lilly, gsk, kyowa kirin, medtronic, merck, nestlé, novartis, pfizer, roche, servier, shire, takeda and ucb outside of the submitted work. outside of the submitted work, cv has a non-financial research relationship with a food retail company and maintains independence in all evaluation activities. this article, however, is not related to this relationship. the nhs long term plan the economic burden of ill health due to diet, physical inactivity, smoking, alcohol and obesity in the uk: an update to - nhs costs ): a survey carried out on behalf of public health england and the food standards agency. london: public health england engaging teenagers in improving their health behaviours and increasing their interest in science (evaluation of lifelab southampton): study protocol for a cluster randomized controlled trial longitudinal tracking of adolescent smoking, physical activity, and food choice behaviors 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adolescents in digital health interventions for obesity prevention and management. healthcare (basel) a systematic review of digital interventions for improving the diet and physical activity behaviors of adolescents a meta-analytic review of obesity prevention programs for children and adolescents: the skinny on interventions that work autonomy and control: the coconstruction of adolescent food choice harnessing adolescent values to motivate healthier eating a values-alignment intervention protects adolescents from the effects of food marketing intervention planning for a digital intervention for self-management of hypertension: a theory-, evidence-and person-based approach the person-based approach to enhancing the acceptability and feasibility of interventions the person-based approach to intervention development: application to digital health-related behavior change interventions idea jamming with teenagers. southampton: university of southampton london: ministry of housing, communities & local government healthy conversation skills: increasing competence and confidence in front-line staff making every contact count': evaluation of the impact of an intervention to train health and social care practitioners in skills to support health behaviour change the link between pupil health and wellbeing and attainment: a briefing for head teachers, governors and staff in education settings. london: public health england associations between objectively measured physical activity and academic attainment in adolescents from a uk cohort obesity impairs academic attainment in adolescence: findings from alspac, a uk cohort a mixedmethods investigation to explore how women living in disadvantaged areas might be supported to improve their diets health promotion from the perspective of social cognitive theory. psychol health the behavior change technique taxonomy (v ) of hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions from theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques the effect of a behaviour change intervention on the diets and physical activity levels of women attending sure start children's centres: results from a complex public health intervention the southampton initiative for health: a complex intervention to improve the diets and increase the physical activity levels of women from disadvantaged communities estimation of fruit and vegetable intake using a two-item dietary questionnaire: a potential tool for primary health care workers an assessment of maturity from anthropometric measurements the validity of the youth physical activity questionnaire in - -year-old scottish adolescents the development of a paediatric health related quality of life measure for use in economic evaluation: the child health utility d (chu d). sheffield: the university of sheffield reliability and validity of an adapted version of the cantril ladder for use with adolescent samples a modification to the behavioural regulation in exercise questionnaire to include an assessment of amotivation reliability and validity of the se-hepa: examining physical activity-and healthy eating-specific self-efficacy among a sample of preadolescents self-determination, smoking, diet and health meta-synthesis of health behavior change meta-analyses london: local government association cluster randomized trials with treatment noncompliance process evaluation of complex interventions: medical research council guidance using thematic analysis in psychology tackling of unhealthy diets, physical inactivity, and obesity: health effects and cost-effectiveness the green book: appraisal and evaluation in central government we acknowledge sarah jenner, sara simao, daniel penn-newman, daniella watson and taylor morris who helped us collect preliminary data and develop research materials. kris tsenova created the artwork for the digital intervention and the education module. we are grateful to our ppi members ros horlock, paula twynham and rosie mackay for their advice and support. mrc lifecourse epidemiology unit, southampton general hospital, university of southampton, southampton, uk. publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -nkosr br authors: williams, katie; ruiz, fernanda; hernandez, felix; hancock, marian title: home visiting: a lifeline for families during the covid- pandemic date: - - journal: arch psychiatr nurs doi: . /j.apnu. . . sha: doc_id: cord_uid: nkosr br nan the district of columbia (district of columbia department of health, ). additionally, women who live in poverty, are immigrants, live with extreme stress, experience conflict situations, and have low social supports are at a higher risk of experiencing perinatal depression (who, ) . in recent months, us news reports have chronicled facts which illustrate that minority populations and underserved communities are significantly impacted by the coronavirus, the lack of resources and economic hardships. the coronavirus pandemic has brought forth chronic systemic issues of racism that have plagued the us for generations, with an overrepresentation of covid- related hospitalizations and deaths among black populations and minorities nationally (garcia-navarro, ; centers for disease control and prevention, ) . infection statistics in the district of columbia demonstrate stark differences in rates of covid- infection and related deaths. infection rates are heavily focused on communities with lower average income and higher rates of black and latinx populations and in parallel, death rates among black individuals represent % ( of deaths) of the total deaths, while they constitute only % of the district population (united states census, ; district of columbia, ). the economic downfall resulting from the pandemic and a never before seen demand to stay-at-home has unveiled higher rates of mental health concerns, life disruptions, as well as violence in the home. not only putting lives at risk, these effects are also detrimentally affecting our society's capacity to serve as positive role models and to foster healthy environments in which to grow our children. research links the effects of social isolation and loneliness to poor mental and physical health. parents, and especially low-income parents, are disproportionately worried about the infection, and disproportionately likely to feel "disrupted by the outbreak" panchal et al, ) . we have also seen the increase in domestic violence cases and considerable evidence points to the fact that domestic violence and child abuse often co-occur in nearly % of cases, experts believe the quarantine has high probability for increasing the rates of violence children are experiencing in the home (bosman, ; kamenetz, ; institute of medicine, ) . parenting is also impacted by social determinants of health. according to the most recent public dashboard published by child family services agency (cfsa) in the washington dc, % of the number of children served by cfsa are between and years of age, and the two groups with the highest incident of reports are african american and latinx families (child family services agency, ). the top family issues resulting in maltreatment reports for -to year age group include substance abuse, inadequate resources/unstable living situation, domestic violence and abandonment (child family services agency, ). the body of evidence is abundantly clear that social determinants of health and exposure to chronic stress has an impact on the body and overall health. however, risk is not destiny. research also tells us that protective factors and resiliency within individuals, families and communities, prevent and ameliorate the effects of social determinants of health. they allow us to respond to adversity in an adaptive and functional way. promoting protective factors and fostering resiliency is an effective strategy to address health disparities (palmer et al, ) . to this end, our federally qualified health care organization used this evidence base to develop and utilize the strategy of home visiting to foster resiliency among vulnerable individuals and families. home visiting is an essential preventative social service model that builds on the families' own strengths j o u r n a l p r e -p r o o f and supports them to navigate circumstances and stressors contributing to health inequities in underserved communities. home visitors provide services that improve health care access and education to participants; they collaborate with families to assist in navigating health and social systems and give dedicated attention that may be more problematic to obtain in the traditional health system (centers for disease control and prevention, ) . nurses and clinically trained technicians are also direct-care providers in some home visiting models, including nurse family partnership, supporting individuals with health education, counseling, and medical services outside of the clinic system. while there is no nationally recognized definition for home visiting, the district of columbia home visiting council has developed a definition to better represent the services and position home visiting specific to the spectrum of social and health services in our geographic region. this definition will be published in their upcoming annual report with an excerpt below. home visiting is a service delivery strategy that serves as a prevention and early intervention support for expecting parents and families of young children from before birth until entry into kindergarten. in these voluntary programs, trained home visitors and participant family members regularly meet in the home or another comfortable setting designated by the family. a key characteristic of these programs is that each implements a model for addressing specific maternal, family, and child outcomes through education, counseling, coaching, and other services. home visitors also provide families with connections to community-based services and resources relevant to their goals (dc home visiting council, ). moreover, home visiting programs are designed to support families who are overburdened. individuals and families currently managing the health and social consequences of the covid- pandemic are impacted greatly by the detriments of the health inequities that affect them. the specific tools, practices, and theories that guide home visiting programs are established to address extreme social challenges and therefore home visiting programs are well-positioned to support families in these extraordinarily difficult times. today, home visitors are the lifelines to many families. home visiting program models vary based on factors such as target audience, outcomes measured, duration and frequency of home visits, and evidence available on the practice. our organization, mary's center, currently offers four home visiting models supporting our organization's mission which is to embrace all communities and provide high-quality healthcare, education, and social services in order to build better futures. mary's center home visiting department's mission is to engage families through different phases of perinatal and early childhood years, involving all members of the family through programming and resources. healthy families america (hfa) and parents as teachers (pat) are evidence-based national models (home visiting evidence of effectiveness, ; ). hfa provides intensive home visitation services to overburdened families at risk for child abuse and neglect and supports them to ultimately prevent abuse and neglect (healthy families america, ) . pat is based on a theory that influencing parenting knowledge, attitudes, behaviors and family well-being affects the child's developmental trajectory, with an intentional focus on school readiness (parents as teachers, ). the father child attachment program is specifically designed to work with fathers in order to promote positive father involvement and j o u r n a l p r e -p r o o f work towards strengthening the father-child relationship. lastly, healthy start is a national initiative designed to improve maternal and infant health outcomes and reduce racial and ethnic differences in adverse perinatal outcomes and infant deaths. while eligibility criteria differ between programs, all four serve to engage families who live throughout the metropolitan washington dc area, including prince george's county in lower maryland. while each program is built and implemented differently, national research on home visiting strategies show that programs are instrumental in supporting families in their ability to process and navigate social and health challenges. us health and human services departments have supported the home visiting evidence of effectiveness programs (homvee) since , a team conducting thorough and transparent reviews of home visiting research literature and outcomes. positive health outcomes unveiled through homvee and locally-hosted evaluations include the frequency of child visits for preventative care, improved school readiness, improved family economic self-sufficiency, and positive parental attitudes about their ability and competency as parents (dc home visiting council, ; opre, ). health and livelihood outcomes demonstrate that families who participate in home visiting programs are more likely to have healthy babies and healthy moms, confident parents with positive parenting practices and safe homes (munns, ; national home visiting resource center, ) . in addition, cost savings from home visiting programs are manifested in lower rates of emergency room visits for children, reduced involvement in government systems such as child protective services, as well as benefits to society encompassed in maternal and child health outcomes. studies have found a return on investment of $ . success within the parameters of home visiting has been quantified, revealing effectiveness on meeting health and social needs for families, women, and children. however, home visiting as a strategy looks differently for every family. to quantify what success looks like when each strategy is tailored to the needs of the family can miss the mark on how home visiting inevitably shows up and impacts a community as a whole. home visiting's real success may be more difficult to measure in areas such as employment, or learning and practicing a different, less punitive strategy to parenting. strategies applied in home visiting programs support participants and their families in developing tools and accessing resources to garner growth, confidence and self-sufficiency. resources are not only those tangible and observable ones, such as a stress-management course for young parents or transportation to a health appointment, but also intangible, personal tools to support participants in becoming their best selves. some of these practices and resources with impact on health equities are described below. standardized screenings are an integral part of home visiting that facilitate the early and regular identification of risk factors negatively affecting the health and livelihood of our participants. screenings serve to monitor health and social risk factors for all participants, invite opportunities for discussion and allow for exploration of sensitive and difficult experiences, and identify risk situations warranting referral for further follow up. while screenings are often dictated by funders, those applied in mary's center programs include evidence-based tools to monitor depression and perinatal mood disorders, intimate partner violence, adverse childhood experiences, substance abuse, and child development milestones. family goal planning is a tool used to facilitate participant and home visitor working together to develop goals and break those goals into meaningful and manageable steps/objectives. when facing chronic social hardship, trauma, and challenge, it is difficult for one to think beyond survival, losing the ability to consider the future and possibly damaging one's feelings of self-worth and perceived or actual threats to family functioning. the process of breaking larger goals into small steps assists parents in developing problem-solving skills, increases the individual's sense of power over their situation, and supports adult brain development. the skills parents build in the process of outlining and achieving self-identified successes changes the way parents view the world, increases their self-efficacy, enhances internal motivation and builds protective factors. a strength-based approach is another practice integrated into mary's center home visiting programs which draws attention to a participant's strengths and abilities rather than the problems, deficits, and pathologies they may be facing (saleebey, ) . in strength-based practice, the participant is supported to identify and build upon these positive traits and work towards positive change. with individuals who have been raised in communities of hardship and limited social and emotional support, this change in perspective and attention to personal strengths elicits a shift towards a more positive mind-set, optimism and confidence, ultimately contributing to healthier and more positive behaviors. trauma-informed care is applied in home visiting to support participants in understanding the effects of trauma on their minds and bodies, as well as identify triggers, physical manifestations of stress, and methods of self-regulation and self-care. utilizing a trauma-informed lens in home visiting allows for the creation of a safer and more trusting environment where participants can explore emotions and past experiences without judgement or expectations. home visitors form connections, support participants in recognizing and naming emotions, help people improve their self-agency, and create consistent and clear boundaries (gates, ) . application of this approach with adults has been shown to help them to build positive attachments with children, create a safe environment and nurture relationships with their children (cairone, rudick & mcauley e., ). an essential part of home visiting is flexibility. prior to the pandemic, staff would hold visits where families were physically located; whether it be in the home or a doctors' office waiting room. using the facilitating attuned interactions approach, this presence is not only felt physically but also expressed emotionally (erikson institute, ) . home visitors tailor their support according to the needs of the participants and are consistently present adjusting to what may be most beneficial at the time. for example, a parent may be seeking a listening ear to express frustration with accessing health services, while a moment later, he/she may be seeking assistance in planning for her child's upcoming medical appointment. the tools and models outlined contribute to the development of trusting relationships while positively contributing to participants' sense of self and confidence. all the while, these approaches model practices that parents themselves can put in place with their children and contribute to more positive productive parent-child relationships. america provided guidelines and adaptations in response to covid- to continue to support local programs (national alliance of home visiting models, ). as an agency, mary's center quickly developed guidelines and protocols in response to the pandemic following the guidelines provided by the centers for disease control (cdc), home visiting national models, and allied professionals such as medicine and behavioral health who had research to support this service modality (hutkins seda, ). for example, in a systemic review of tele-behavioral health services using cognitive behavioral therapy (cbt), it was found that tele-behavioral health services are equal to in-person therapy and may have more long-term impact beyond the end of treatment (dettore, pozza & andersson, ; vogel et al., ) . in addition, mary's center has provided tele-medicine and tele-behavioral health services for several years showing success since our use of tele-health in . a managed care organization partner, amerihealth, has publicly commented that mary's center's telemedicine has been "extremely beneficial" with performance outweighing other similar providers, and exceeding national quality assurance benchmarks for medical services such as diabetes care (evans & koppelman, ) . it is with these successes that many protocols were easily adapted to home visiting programming. when visits became virtual, hfa released prompts to support home visitors with achieving the hfa best practice standards to "assess, address, and promote positive parent-child interaction, attachment, and bonding and the development of nurturing parent-child relationships" (healthy families america., ). these new guidelines allow for home visitors to either use observations through video visits, or openended questions to elicit parents description of their interaction with their children on phone calls (healthy families america, ). similarly, to adjust to tele-home visits, parents as teachers introduced "verbal videos," a technique that guides parents to narrate telephone visits, which allows parents to observe their children's cues while stimulating language development. with the parent-child interaction observations or narrations, home visitors continue to follow programmatic guidelines as part of in-person visits, and address specific strengths while introducing relevant curriculum to address parents' concerns. it is in this same space where home visiting has adapted its strategy to provide the support matching participants' most immediate needs. basic material needs including groceries, diapers and formula, safe transportation, and safe secure housing all came to the forefront as most sought-after resources during the initial months of the pandemic. within this context, many resources and opportunities became available in the metro area, yet logistics were consistently changing, eligibility criteria was often restricted or varied, and communication about what was available was challenged by the stay-at-home order itself. while families are required to stay at home, the home visitor is a central resource providing access to important services relevant and appropriate for families. home visitors also have already-established relationships with other community-based programs, consistently receiving up-to-date information and a direct contact to optimize family's time and chance of success. beyond the creative contact methods and structural strategies of home visiting, home visitors recognized that simply living under covid- is a new norm for participants. mary's center home visiting is aware that covid- has magnified issues already present in the environment and our program makes space to intentionally incorporate self-care strategies for our participants, especially parents. an example of this is the father-child attachment program that has opened forums for fathers to discuss masculinity and mental health amid the social upheaval of the pandemic and evolving awareness around police brutality. home visitors and participants have co-created space that allows for the discussion of the j o u r n a l p r e -p r o o f emotional and mental toll these stressors present. while the most notable consequences of the pandemic have been those hindering health and access to services, there are positive effects of the paradigm shift caused by the pandemic. access to some health services available through a tele-format has increased during the past few months. at mary's center we have seen an increase in number of patients seeking mental health services offered virtually. anecdotally, reasons for this increase may be attributed to participants having more time available to attend clinical appointments remotely while increased need for these services may also be a factor. in complement to individual therapy, group care is increasing across the country; postpartum support international reports the number of women participating in online support groups has increased % from february to april (maternal mental health leadership alliance, ). this expansion is not exclusive to mental health services and the potential of tele-health services expanding access to other areas of care is changing entire landscapes of health systems. at mary's center, tele-health services are already an integral component of our service delivery strategy, and are growing in areas of medical, dentistry, behavioral health, social services, and home visiting, improving access for those who previously did not attend inperson appointments. national home visiting models have made these easy, establishing guidelines for tele-visits years ago, and now expanded support and investment for their implementation is warranted within this system as well as nationally (healthy families america, ; nurse family partnership, ). families have been negatively impacted by the pandemic yet the effect is deeper among families who are suffering from social and health inequities. the pandemic has unveiled countless examples of the wideranging disparities -unemployment, food scarcities, anxieties, depression, loneliness and family stressors. as these social determinants and upstream aspects of well-being and health are supported with safety net services such as home visiting, these programs need to be financed, utilized and expanded now more than ever. there is a call for investment in innovative home visiting models to address the new and developing needs of families in this time of crises. nfp is an evidence-based model where nurses deliver in-home clinical and social services directly to women and families during vulnerable periods of life such as pregnancy and postpartum. programs where fathers and male partners are engaged limited even as the literature focuses attention to the role of the father in a child's development and the importance of the family unit. mary's center is at the forefront of moving these new models forward, through participation in local advocacy and leadership in home visiting coalitions. increased investment and support for this work would extend the reach and the impact of home visiting services to those who most need it. while existing evidence demonstrates positive outcomes, additional research on innovative home visiting models would support funding and expansion of such services. research on the fidelity of programs to a national model is informative. of even greater value would be further understanding of program outcomes in different contexts and amid new social and economic challenges. particularly now, as models across the country are adjusting to virtual engagement, understanding of home visiting best-practices and effectiveness of this strategy is warranted. until larger systemic changes occur in social and economic policy to address racial and ethnic disparities, families will continue to experience hardships resulting from inequity in social determinants of health. domestic violence calls mount as restrictions linger: 'no one can leave'. the new york times home visiting issues and insights creating a trauma-informed home visiting program. health resources and services administration infant mortality covid- in racial and ethnic minority groups collaborating with community health workers to enhance the coordination of care and advance health equity fy needs assessment efficacy of technology-delivered cognitive behavioral therapy for ocd versus control conditions, and in comparison with therapist-administered cbt: meta-analysis of randomized controlled trials perinatal health and infant 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authors: coggon, john; gostin, lawrence o title: postscript: covid- and the legal determinants of health date: - - journal: public health ethics doi: . /phe/phaa sha: doc_id: cord_uid: w t tj this is a short postscript to the public health ethics special issue on the legal determinants of health. we reflect briefly on emerging responses to covid- , and raise important questions of ethics and law that must be addressed; including through the lens of legal determinants, and with critical attention to what it means to protect health with justice. since this special issue of public health ethics went into production, the global pandemic of covid- has led to extraordinary measures being taken in many countries, including those where we each live (the uk and usa, respectively). as we draft this short postscript, president trump has declared a national emergency in the usa, and the fifty state governors have declared state emergencies. president trump has also now taken the extraordinary move of announcing that he is stopping the usa's funding of the world health organization, which is a highly damaging action in the midst of a pandemic. prime minister boris johnson, who has since been heavily impacted through contracting covid- , declared a national emergency on rd march, , in the uk, following which time the uk parliament has granted extensive emergency powers through the coronavirus act . the resultant position, as we write, is that in the usa, most governors have ordered residents to stay at home and all non-essential businesses to close (gostin et al., a,b) . in the uk, following early highly permissive governance approaches, the government and devolved administrations are now using emergency laws significantly to curtail general freedoms in efforts to contain the spread of covid- (coggon, ) . in both of our countries, as elsewhere, an overbearing concern has been the functioning of the healthcare systems. covid- could overrun doctors' offices and hospitals, which are also short on critical supplies such as personal protective equipment and ventilators. scrutiny and evaluation of the covid- response nationally and globally are ongoing. when we come to look back on this crisis, we will see social and legal determinants having a marked impact, both at national and global levels. how effective have governments and the world health organization been in curtailing the spread of sars-cov- ? how have they balanced public health with human rights? what lessons can we learn about national and global preparedness? as responses to the pandemic run, and after, it will be crucial to explore how law and governance have been used (and not used), and to question their effectiveness, their compliance with human rights, and how equitable they have been. across the world, there have been notable distinctions in different national responses. governments, experts, and citizens are watching closely to see how different methods of governance are, and are not, working as the crisis unfolds and as our understanding improves. problems abound in relation to scientific uncertainty, paucity of data, and the extreme challenges of achieving equitable, proportionate responses. at one point, we may have considered it unimaginable to have a largescale 'lockdown' in liberal western democracies, but that is exactly what we have seen in many nations, including our own. at the same time, concerns proliferate for nations and communities who stand to be harder hit still and are ill-resourced or otherwise lacking in infrastructural capacity to respond effectively. the virus, for example, is poised now to spread through africa and the indian sub-continent. this is a global health doi: . /phe/phaa v c the author(s) . published by oxford university press. available online at www.phe.oxfordjournals.org public health ethics • - emergency, and it demands coordinated responses and political leadership that take a global outlook. within and among nations, we already see gross inequities. these will become starker as time progresses, and must be given careful, collaborative, cross-disciplinary and cross-sector scrutiny. colleagues in global and public health, including scholars in ethics and law, will therefore rightly be attentive to the implications of this crisis at subnational, national, international, and global levels. the challenges of the acute and sustained events consequent to covid- , across the globe, have already laid bare the sheer vulnerability of human health, the fragility of social institutions that we may take for granted, our astounding interconnectedness, and the need that these bring for equitable, transparent methods of coordination and regulation; of good governance, including for the public's health. the need for brave and contemplated political leadership is clear; leadership that looks globally, not just nationally. and however different countries' responses come to be judged in hindsight, the power of law, its limits, its risks and its relationships to health and other vital values, could not be made starker. in using law as a tool to serve the public's health, the need for scientific evidence is clear, as are the challenges of seeking societal responses to threats that are not immediately visible. a key lesson already learned is that we must invest in public health and prepare for rapid identification and response when a situation such as this arises. beyond a sound scientific evidence base, for legal responses to enjoy legitimacy, they must accord with the rule of law, including by exhibiting a clear commitment to fair and equal treatment, proportionality and administration according to principles of good governance. there is inevitable urgency to responses to covid- , but they form parts of a long and complex process. a measure of this moment, which will demand continued analysis as and after it unfolds, will be how well governments fare in protecting health with justice. there is a vital role in continued efforts for scholars interested in public health ethics and law and the legal determinants of health. beyond liberty: social values and public health ethics in responses to covid- presidential powers and response to covid- responding to covid- : how to navigate a public health emergency legally and ethically this special issue was produced following a launch event for the lancet-o'neill commission's report on the legal determinants of health, hosted by the centre for health, law, and society at the university of bristol, uk, on october : 'mapping the path to global health with justice: a critical discussion of social structures, health inequities, and the legal determinants of health'. the event was supported by the university of bristol law school's centre fund. none declared. key: cord- -citynr c authors: p. shetty, nandini; s. shetty, prakash title: epidemiology of disease in the tropics date: - - journal: manson's tropical diseases doi: . /b - - - - . - sha: doc_id: cord_uid: citynr c nan the study of epidemiology in the tropics has undergone major changes since its infancy when it was largely a documentation of epidemics. it has now evolved into a dynamic phenomenon involving the ecology of the infectious agent, the host, reservoirs and vectors as well as the complex mechanisms concerned in the spread of infection and the extent to which this spread occurs. similar concepts in the study of epidemiology apply to communicable as well as non-communicable diseases. the understanding of epidemiological principles has its origins in the study of the great epidemics. arguably, the most powerful example of this is the study of that ancient scourge of mankind, the so-called black death or plague. a study of any of the plague epidemics throughout history has all the factors that govern current epidemiological analysis: infectious agent, host, vector, reservoir, complex population dynamics including migration, famine, fi re and war; resulting in spread followed by quarantine and control. the world health report : 'fighting disease, fostering development', states that infectious diseases are the world's leading cause of premature death. infectious diseases account for % of deaths in low-income countries (figure . ) and up to % of deaths in children under years of age worldwide. africa and south-east asia carry the highest mortality due to infectious diseases (figure . ). in addition, new and emerging infections pose a rising global threat (table . ). no more than six deadly infectious diseases: pneumonia, tuberculosis, diarrhoeal diseases, malaria, measles and more recently, hiv/aids, account for half of all premature deaths, killing mostly children and young adults (figure . ). acute respiratory infections (aris) are the leading cause of death of infectious aetiology, killing more than million people a year, . million of which constitute children under the age of fi ve. among the countries of the world that carry % of the child mortality burden, - % of the under- mortality is due to pneumonia and nearly % of this pneumonia mortality occurs in the africa and south and south-east asia regions. the majority of this burden is borne during early childhood, with the greatest risk from mortality occurring during the neonatal period. the global incidence of ari in children is estimated to be million cases per year. this range of infections, which includes pneumonia in its most serious form, accounts for more than % of the global burden of disease. pneumonia often affects children with low birth weight or those whose immune systems are weakened by malnutrition or other diseases. caused by different viruses or bacteria, ari is closely associated with poverty, overcrowding and unsanitary household conditions. several other factors seem to exacerbate the disease. exposure to tobacco smoke increases the risk of contracting these infections, and many studies implicate both indoor and outdoor air pollution. indoor air pollution has been the focus of particular concern: specifi cally, the soot and smoke associated with the burning of biomass fuels such as wood, coal, or dung. many people in the developing world, mostly in rural areas, rely on biomass fuels for heating or cooking. a cause-and-effect relationship between indoor air pollution and ari has been diffi cult to prove. even so, the world bank estimated in that switching to better fuels could halve the number of pneumonia deaths. approaches to the management of childhood pneumonia in the tropics are hampered by lack of diagnostic facilities to identify the aetiological agent. the who has devised a simple algorithm for use in fi eld situations, by primary healthcare workers, using clinical criteria such as respiratory rate and indrawing of ribs to decide whether a child needs hospitalization. proper implementation of this strategy has been shown to reduce the mortality from childhood pneumonias by - %. however, implementation of community ari treatment programmes remains patchy and current rates of children with ari being taken to a health provider are ~ % in africa and south asia. in nearly half of the countries with available data, less than % of the children with ari were taken to an appropriate healthcare provider. the aids pandemic has emerged as the single most defi ning occurrence in the history of infectious diseases of the late twentieth and early twenty-fi rst centuries. according to the aids epidemic update of december (unaids and who), the epidemiology of hiv in the tropics varies enormously from place to place (figure latest estimates show some . million people ( million adult women) were living with hiv in , including the . million people who became newly infected in the past year. aids claimed some lives in . these estimates are in line with known risk behaviour in this region, where men account for the majority of injecting drug users, and are responsible for sexual transmission of hiv, largely through commercial sex. commercial sex accounts for a large part of the estimated % of hiv infections in china that are due to unprotected heterosexual contact. it also features in the transmission of the virus among men who have sex with men: a recent survey among male sex workers in the southern city of shenzhen found that % of them were hivpositive. however, it is the potential overlap between commercial sex and injecting drug use that is likely to become the main driver of china's epidemic. diverse epidemics are underway in india, where, in , an estimated . million indians were living with hiv. although levels of hiv infection prevalence appear to have stabilized in some states (such as tamil nadu, andhra pradesh, karnataka and maharashtra), it is still increasing in at-risk population groups in several other states. as a result, overall hiv prevalence has continued to rise. a signifi cant proportion of new infections is occurring in women who are married and who have been infected by husbands who (either currently or in the past) frequented sex workers. commercial sex (along with injecting drug use, in the states of nagaland and tamil nadu) serves as a major driver of the epidemics in most parts of india. hiv surveillance in found % of commercial sex workers in karnataka ( % in the city of mysore) and % in andhra pradesh were infected with hiv. the wellknown achievements among sex workers of kolkata's sonagachi red-light area (in west bengal, india) have shown that safe sex programmes that empower sex workers can curb the spread of hiv. condom use in sonagachi has risen as high as % and hiv prevalence among commercial sex workers declined to fewer than the combination of high levels of risk behaviour and limited knowledge about aids among drug injectors and sex workers in pakistan favours the rapid spread of hiv, and new data suggest that the country could be on the verge of serious hiv epidemics. most countries in asia still have the opportunity to prevent major epidemics. bangladesh, where national adult hiv prevalence is well below %, began initiating hiv prevention programmes early in its epidemic. indonesia is on the brink of a rapidly worsening aids epidemic. with risk behaviour among injecting drug users common, a mainly drug-injection epidemic is already spreading into remote parts of this archipelago. in malaysia, approximately people were living with hiv in , the vast majority of them young men (aged - years), of whom approximately % were injecting drug users. after peaking at % in , national adult hiv prevalence in cambodia fell by one-third, to . % in . the reasons for this are two-fold: increasing mortality and a decline in hiv incidence due to changes in risk behaviour. thailand has been widely hailed as one of the success stories in the response to aids. by , estimated national adult hiv prevalence had dropped to its lowest level ever, approximately . %. however, thailand's epidemic is far from over; infection levels in the most at-risk populations are much higher: just over % of brothel-based female sex workers were hiv-infected in , as were % of injecting drug users who attended treatment clinics. while cambodia and thailand in the s were planning and introducing strategies to reverse the spread of hiv, another serious epidemic was gaining ground in neighbouring myanmar. there, limited prevention efforts led to hiv spreading freely. consequently, myanmar has one of the most serious aids epidemics in the region, with hiv prevalence among pregnant women estimated at . % in . the main hiv-related risk for many of the women now living with the virus was to have had unprotected sex with husbands or boyfriends who had been infected while injecting drugs or buying sex. in japan, the number of reported annual hiv cases has more than doubled since - , and reached in ; the highest number to date. much of this trend is due to increasing infections among men who have sex with men. prevalence of hiv remains low in the philippines and lao pdr. the advance of aids in the middle east and north africa has continued, with latest estimates showing that people became infected with hiv in . approximately people are living with hiv in this region. an estimated adults and children died of aids-related conditions in . although hiv surveillance remains weak in this region, more comprehensive information is available in some countries (including algeria, libya, morocco, somalia and sudan). available evidence reveals trends of increasing hiv infections (especially in younger age groups) in such countries as algeria, libya, morocco and somalia. the main mode of hiv transmission in this region is unprotected sexual contact, although injecting drug use is becoming an increasingly important factor (and is the predominant mode of infection in at least two countries: iran and libya). infections as a result of contaminated blood products, blood transfusions or a lack of infection control measures in healthcare settings are generally on the decline. by far the worst-affected country in this region is sudan. in a country with a long history of civil confl ict and forced displacement, internally displaced persons face higher rates of hiv infection. for instance, among displaced pregnant women seeking antenatal care in khartoum in , hiv prevalence of . % was found compared with under . % for other pregnant women. the epidemic in latin america is a complex mosaic of transmission patterns in which hiv continues to spread through male-tomale sex, sex between men and women, and injecting drug use. sub-saharan africa has just over % of the world's population, but is home to more than % of all people living with hiv - . the rights and status of women and young girls deserve special attention. around the world -from south of the sahara in africa and asia to europe, latin america and the pacifi c -an increasing number of women are being infected with hiv. it is often women with little or no income who are most at risk. widespread inequalities including political, social, cultural and human security factors also exacerbate the situation for women and girls. in several southern african countries, more than three quarters of all young people living with hiv are women, while in sub-saharan africa overall, young women between and years old are at least three times more likely to be hiv-positive than young men (figure . ). in many countries, marriage and women's own fi delity are not enough to protect them against hiv infection. among women surveyed in harare (zimbabwe), durban and soweto (south africa), % reported having one lifetime partner, % had abstained from sex at least until the age of (roughly the average age of fi rst sexual encounter in most countries in the world). yet, % of the young women were hiv-positive. many had been infected despite staying faithful to one partner. diarrhoea remains one of the most common diseases affl icting children under years of age and accounts for considerable mortality in childhood. estimates from studies published between and show that there was a median of . episodes of diarrhoea per child-year in developing countries. this indicates little change from previously described incidences. estimates of mortality revealed that . children per /year in these countries died as a result of diarrhoeal illness in the fi rst years of life, a decline from the previous estimates of . - . per /year. the decrease was most pronounced in children aged under one year. despite improving trends in mortality rates, diarrhoea accounted for a median of % of all deaths of children aged under years in developing countries, being responsible for . million deaths per year. there has not been a concurrent decrease in morbidity rates attributable to diarrhoea. as population growth is focused in the poorest areas, the total morbidity component of the disease burden is greater than previously. diarrhoea remains a disease of poverty affl icting malnourished children in crowded and contaminated environments. efforts to immunize children against measles, provide safe water and adequate sanitation facilities, and to encourage mothers to exclusively breast-feed infants through to months of age can blunt an increase in diarrhoea morbidity and mortality. preventive strategies to limit the transmission of diarrhoeal disease need to go hand in hand with national diarrhoea disease control programmes that concentrate on effective diarrhoea case management and the prevention of dehydration. the factors contributing to childhood mortality and morbidity due to diarrhoea are described in table . . studies in asia and africa have clearly shown that establishment of an oral rehydration therapy (ort) unit with training of hospital staff can signifi cantly reduce diarrhoea case fatality rates. for instance, at mama yemo hospital in kinshasa, zaire, there was a % decline in diarrhoea deaths after creation of an ort unit. in may , the world health organization and the united nations children's fund recommended that the formulation of oral rehydration solution (ors) for treatment of patients with diarrhoea be changed to one with a reduced osmolarity and that safety of the new formulation, particularly development of symptomatic hyponatremia, be monitored. a total of patients, including children younger than months, were monitored at the dhaka and matlab hospitals, bangladesh. the risk of symptoms associated with hyponatraemia in patients diarrhoeal disease treated with the reduced osmolarity ors was found to be minimal and did not increase with the change in formulation. changing patterns in the epidemiology of diarrhoea have been noted in many studies. in matlab, bangladesh, acute watery diarrhoea accounted for % of diarrhoea deaths in under-fi ves, while the remaining % were related to dysentery or persistent diarrhoea and malnutrition. this pattern was age dependent, with acute watery deaths being more important in infancy, being associated with % of deaths, and less important in later childhood, being associated with % of deaths. rotavirus is the most common cause of severe diarrhoeal disease in infants and young children all over the world, and an important public health problem, particularly in developing countries where deaths each year are associated with this infection. more than million cases of diarrhoea each year are attributed to rotavirus. in tropical developing countries, rotavirus disease occurs either throughout the year or in the cold dry season. almost all children are already infected by the age of - years. although the infection is usually mild, severe disease may rapidly result in life-threatening dehydration if not appropriately treated. natural infection protects children against subsequent severe disease. globally, four serotypes are responsible for the majority of rotaviral disease, but additional serotypes are prevalent in some countries. the only control measure likely to have a signifi cant impact on the incidence of severe disease is vaccination. since the withdrawal from the market of the tetravalent rhesus-human reassortant vaccine (rotashield, wyeth laboratories) because of an association with intussusception, ruling out such a risk has become critical for the licensure and universal use of any new rotavirus vaccine. recent studies have shown that two oral doses of the live attenuated g p [ ] human rotavirus vaccine were highly effi cacious in protecting infants against severe rotavirus gastroenteritis, signifi cantly reduced the rate of severe gastroenteritis from any cause, and were not associated with the increased risk of intussusception linked with the previous vaccine. man is both the reservoir and natural host of shigella, the commonest cause of dysentery in the tropics. the most severe infections are caused by the s. dysenteriae type (also known as shiga's bacillus); it is also the only serotype implicated in epidemics. infection is by the faecal-oral route and is usually spread by personto-person transmission. it takes only - shigella organisms to produce dysentery, a low infectious dose, whereas million to million organisms may need to be swallowed to cause cholera. during the late s, shiga's bacillus was responsible for a series of devastating epidemics of dysentery in latin america, asia and africa. in , it was detected in the mexican-guatemalan border area and spread into much of central america. an estimated half a million cases, with deaths, were reported in the region between and . in some villages the case fatality rate was as high as %; delayed diagnosis and incorrect treatment may have been responsible for this high death rate. one particularly disturbing feature was the resistance of the bacteria to the most commonly used antibacterial drugs: sulfonamides, tetracycline and chloramphenicol. serious epidemics due to the multiple-drug resistant s. dysenteriae type have occurred recently in bangladesh, somalia, south india, burma, sri lanka, nepal, bhutan, rwanda and zaire. west bengal in india has always been an endemic area for bacillary dysentery. preventive measures include boiling or chlorination of drinking water, covering faeces with soil, protecting food from fl ies, avoiding eating exposed raw vegetables and cut fruits, and washing hands with soap and water before eating and after using the latrine. however, such measures are not easy to implement in most areas. consequently epidemics take their own course and subside only gradually. tuberculosis tuberculosis (tb) is the leading cause of death associated with infectious diseases globally. the incidence of tb will continue to increase substantially worldwide because of the interaction between the tb and hiv epidemics. in many developing countries, tb is mainly a disease of young adults affecting carers and wage-earners in a household, thus placing a huge economic burden on society as a whole. chemotherapy, if properly used, can reduce the burden of tb in the community, but because of the fragile structure of treatment programmes in many countries tb cases are not completely cured and patients remain infectious for a much longer time. another important consequence of poor treatment compliance is development of drug resistance in many developing countries. resistance to tuberculosis drugs is probably present everywhere in the world. worldwide attention was focused on south africa, when in october a research project publicized a deadly outbreak of xdr-tb in the small town of tugela ferry in kwazulu-natal. xdr-tb is the abbreviation for extensively drug-resistant tuberculosis (tb). this strain of mycobacterium tuberculosis is resistant to fi rstand second-line drugs, and treatment options are seriously limited. of tb patients at the church of scotland hospital, which serves a rural area with high hiv rates, some were found to have multi-drug resistance and of these, were diagnosed with xdr-tb. some of these patients died, most within days of diagnosis. of the patients, had been tested for hiv and all were found to be hiv-positive. the patients were receiving antiretrovirals and responding well to hiv-related treatment, but they died of xdr-tb. since the study, more patients have been diagnosed with xdr-tb in kwazulu-natal. only three of them are still alive (see: http://www.who.int/tb/xdr/xdr_jan.pdf). directly observed treatment, short course (dots), is the most effective strategy available for controlling the tb epidemic today. dots uses sound technology and packages it with good management practices for widespread use through the existing primary healthcare network. it has proven to be a successful, innovative approach to tb control in countries such as china, bangladesh, vietnam, peru and countries of west africa. however, new challenges to the implementation of dots include health sector reforms, the worsening hiv epidemic, and the emergence of drugresistant strains of tb. the technical, logistical, operational and political aspects of dots work together to ensure its success and applicability in a wide variety of contexts. million africans who die from malaria each year, most are children under years of age. in addition to acute disease episodes and deaths in africa, malaria also contributes signifi cantly to anaemia in children and pregnant women, adverse birth outcomes such as spontaneous abortion, stillbirth, premature delivery and low birth weight, and overall child mortality. the disease is estimated to be responsible for an estimated average annual reduction of . % in economic growth for those countries with the highest burden. of the four species of plasmodium that infect humans: p. falciparum, p. vivax, p. malariae and p. ovale, p. falciparum causes most of the severe disease and deaths attributable to malaria and is most prevalent in africa south of the sahara and in certain areas of south-east asia and the western pacifi c (figure . ) . the second most common malaria species, p. vivax, is rarely fatal and is commonly found in most of asia, and in parts of the americas, europe and north africa. there are over species of anopheline mosquitoes that transmit human malaria, which differ in their transmission potential. the most competent and effi cient malaria vector, anopheles gambiae, occurs exclusively in africa and is also one of the most diffi cult to control. climatic conditions determine the presence or absence of anopheline vectors. tropical areas of the world have the best combination of adequate rainfall, temperature and humidity allowing for breeding and survival of anophelines. in areas of malaria transmission where sustained vector control is required, insecticide treated nets are the principal strategy for malaria prevention. all countries in africa south of the sahara, the majority of asian malaria-endemic countries and some american countries have adopted insecticide treated nets as a key malaria control strategy. one of the greatest challenges facing malaria control worldwide is the spread and intensifi cation of parasite resistance to antimalarial drugs. the limited number of such drugs has led to increasing diffi culties in the development of antimalarial drug policies and adequate disease management. resistance of p. falciparum to chloroquine is now common in practically all malariaendemic countries of africa (figure . ) , especially in east africa. resistance to sulfadoxine/pyrimethamine, the main alternative to chloroquine, is widespread in south-east asia and south america. mefl oquine resistance is now common in the border areas of thailand with cambodia and myanmar. parasite sensitivity to quinine is declining in several other countries of south-east asia and in the amazon region, where it has been used in combination with tetracycline for the treatment of uncomplicated malaria. in response to widespread resistance of p. falciparum to monotherapy with conventional antimalarial drugs such as chloroquine and sulfadoxine-pyrimethamine, who now recommends combination therapies as the treatment policy for falciparum malaria in all countries experiencing such resistance. the preferred combinations contain a derivative of the plant artemisia annua, which is presently cultivated mainly in china and vietnam. artemisininbased combination therapies (acts) are the most highly effi cacious treatment regimens now available. resistance of p. vivax to chloroquine has now been reported from indonesia (irian jaya), myanmar, papua new guinea and vanuatu. urban and periurban malaria are on the increase in south asia and in many areas of africa. military confl icts and civil unrest, along with unfavourable ecological changes, have greatly contributed to malaria epidemics, as large numbers of unprotected, non- immune and physically weakened refugees move into malarious areas. such population movements contribute to new malaria outbreaks and make epidemic-prone situations more explosive. another disquieting factor is the re-emergence of malaria in areas where it had been eradicated (e.g. democratic people's republic of korea, republic of korea and tadjikistan), or its increase in countries where it was nearly eradicated (e.g. azerbaijan, northern iraq and turkey). current malaria epidemics in a majority of these countries are the result of a rapid deterioration of malaria prevention and control operations. climatic changes have also been implicated in the re-emergence of malaria. in the past years, the worldwide incidence of malaria has quadrupled, infl uenced by changes in both land development and regional climate. in brazil, satellite images depict a 'fi sh bone' pattern where roads have opened the tropical forest to localized development. in these 'edge' areas malaria has resurged. temperature changes have encouraged a redistribution of the disease; malaria is now found at higher elevations in central africa and could threaten cities such as nairobi, kenya. this threat has been hypothesized to extend to temperate regions of the world that are now experiencing hotter summers year on year. although substantial progress has been made in reducing measles deaths globally, in measles was estimated to be the fi fth leading cause of mortality worldwide for children aged < years. measles deaths occur disproportionately in africa and south-east asia. in , the african region of who, with % of the world's population, accounted for % of estimated measles cases and % of measles deaths; the south-east asia region, with % of the world's population and % of measles cases, accounted for % of measles deaths. the burden of mortality in africa refl ects low routine vaccination coverage and high case-fatality ratios. in south-east asia, where vaccination coverage is slightly below average worldwide levels, the large population amplifi es the number of cases and deaths resulting from ongoing measles transmission. the overwhelming majority of measles deaths in occurred in countries eligible to receive fi nancial support from the global alliance for vaccines and immunization's vaccine fund (who, unpublished data ). the majority of measles deaths occur among young children living in poor countries with inadequate vaccination services. like human immunodefi ciency virus, malaria, and tuberculosis, measles can be considered a disease of poverty. however, unlike these diseases, measles can be prevented through vaccination. , in much of the world, particularly sub-saharan africa, south-east asia, china and the pacifi c basin, infection with hepatitis b virus (hbv) is very widespread. the carrier rate in some of these populations may be as high as - %. in developing countries most hepatitis b transmission occurs during the perinatal period. infection between children is another common route of infection; it is not uncommon to fi nd up to % of -year-olds have serological evidence of infection with hbv. intermediate levels of infection ( - %) are seen in parts of the former soviet union, south asia, central america and the northern zones of south america. these high rates of infection lead to a high burden of disease, mainly from the clinical consequences of long-term carriage of the virus, which may include chronic hepatitis, cirrhosis and liver cancer. it has been estimated that hbv infection is the second most common cause of cancer deaths in the world (after tobacco consumption). in india hepatitis b is linked to % of cases of hepatocellular carcinoma and % of cases of cirrhosis of the liver. on the basis of disease burden and the availability of safe and effective vaccines, the who recommended that by the end of the twentieth century, hepatitis b vaccine be incorporated into routine infant and childhood immunization programmes for all countries. the effi cacy of universal immunization has been shown in different countries, with striking reductions of the prevalence of hbv carriage in children. most important, hepatitis b vaccination can protect children against hepatocellular carcinoma and fulminant hepatitis, as has been shown in taiwan. nevertheless, the implementation of worldwide vaccination against hbv requires greater effort to overcome the social and economic hurdles. safe and effective antiviral treatments are available but are still far from ideal, a situation that, hopefully, will be improved soon. with hepatitis b immunization, the global control of hbv infection is possible by the end of the fi rst half of twenty-fi rst century. tetanus is a vaccine-preventable disease that causes a total of deaths annually. of particular concern is maternal and neonatal tetanus (mnt), which can be prevented through immunization of the mother in pregnancy. in , neonatal tetanus alone was responsible for an estimated deaths. in addition, an estimated - non-immunized women worldwide die each year from maternal tetanus that results from postpartum, postabortal or postsurgical wound infection with clostridium tetani. while the focus is on priority countries, % of the neonatal tetanus deaths occur in countries. unicef spearheaded the effort to eliminate mnt by the year , with the support of numerous partners. mnt elimination is defi ned as less than one case of neonatal tetanus per live births at district level. the main strategies consist of promotion of clean delivery practices, immunization of women with a tetanus toxoid (tt) containing vaccine, and surveillance. maternal tetanus immunization is, in most developing countries, implemented as part of the routine immunization programme. however, large areas remain underserved, due to logistical, cultural, economical or other reasons. in order to achieve the target of mnt elimination by , and to offer protection to women and children otherwise deprived from regular immunization services, countries are encouraged to adopt the high risk approach. this approach implies that, in addition to routine immunization of pregnant women, all women of child-bearing age living in high risk areas are targeted for immunization with three doses of a tetanus toxoid containing vaccine (tt or td). by the end of vaccination against a range of bacterial and viral diseases is an integral part of communicable disease control worldwide. vaccination against a specifi c disease not only reduces the incidence of that disease, but it also reduces the social and economic burden of the disease on communities. very high immunization coverage can lead to complete blocking of transmission for many vaccinepreventable diseases. the worldwide eradication of smallpox and the near-eradication of polio from many countries provide excellent examples of the role of immunization in disease control. despite these advances many of the world's poorest countries do not have access to vaccines and these infections remain among the leading global causes of death. the special programme for research and training in tropical diseases (tdr) of the world health organization has designated several infectious diseases as 'neglected tropical diseases' (ntds) that disproportionately affl ict the poor and marginalized populations in the developing regions of sub-saharan africa, asia and the americas. infectious diseases are considered as 'neglected' or 'orphan' diseases when there is a lack of effective, affordable, or easy to use drug treatments. as most patients with such diseases live in developing countries and are too poor to pay for drugs, the pharmaceutical industry has traditionally ignored these diseases. ntds cause an estimated to million deaths annually and cause a global disease burden equivalent to that of hiv-aids. who estimates that at least billion people, i.e. onesixth of the world's population suffers from one or more neglected tropical diseases, while other estimates suggest the number to be much higher. some diseases affect individuals throughout their lives, causing a high degree of morbidity and physical disability and, in certain cases, gross disfi gurement. others are acute infections, with transient, severe and sometimes fatal outcomes. patients can face social stigmatization and abuse, which only add to the already heavy health burden. neglected tropical diseases are contrasted with the 'big three' diseases (hiv/aids, tuberculosis and malaria) which receive much more attention and funding. the current neglected diseases portfolio includes parasitic diseases of protozoan origin like kala-azar (leishmaniasis), african sleeping sickness (african trypanosomiasis) and chagas' disease (american trypanosomiasis) as well as those caused by helminths such as schistosomiasis, lymphatic fi lariasis, onchocerciasis (river blindness) and dracunculiasis (guinea worm). infestations due to soil transmitted helminths such as ascariasis, trichuriais and hookworm also belong to the latter category. other neglected diseases include those of bacterial origin such as leprosy, buruli ulcer and trachoma as well as those of viral origin like dengue fever which are vector-borne. even cholera and yellow fever are considered by some as ntds, while some include cysticercosis, hydatidosis and food-borne trematode infections. it is now believed that ramped up efforts against the 'big three', will yield far bigger dividends if they are coupled with concerted attack on ntds . evidence now points to substantial geographical overlap between the neglected tropical diseases and the 'big three', suggesting that control of the neglected tropical diseases could become a powerful tool for effectively combating hiv/aids, tuberculosis, and malaria. since , resurgent and emerging infectious disease outbreaks have occurred worldwide. in addition, many diseases widely believed to be under control, such as cholera, dengue and diphtheria, have re-emerged in many areas or spread to new regions or populations throughout the world (figure . ) . a growing population and increasing urbanization contribute to emerging infectious disease problems. in many parts of the world, urban population growth has been accompanied by overcrowding, poor hygiene, inadequate sanitation and unclean drinking water. urban development has also caused ecological damage. in these circumstances, certain disease-causing organisms and some of the vectors that transmit them have thrived, making it more likely that people will be infected with new or re-emerging pathogens. the existing public health infrastructure is already overtaxed and ill prepared to deal with new health threats. breakdown of public health measures due to civil unrest, war and the movement of refugees has also contributed to the re-emergence of infectious diseases (table . ). international travel and commerce have made it possible for pathogens to be quickly transported from one side of the globe to the other (figure . ) . examples of new and resurgent infections include ebola, dengue fever, rift valley fever, diphtheria, cholera, nipah virus infection, west nile virus infection, severe acute respiratory syndrome (sars) and avian infl uenza. in ebola (named after the ebola river in zaire) fi rst emerged in sudan and the democratic republic of the congo (formerly zaire). ebola virus occurs as four distinct subtypes: zaïre, sudan, côte d'ivoire and reston. three subtypes, occurring in the democratic republic of the congo, sudan and côte d'ivoire, have been identifi ed as causing illness in humans. ebola haemorrhagic fever (ehf) is a febrile haemorrhagic illness which causes death in - % of all clinically ill cases. the natural reservoir of the ebola virus is unknown despite extensive studies, but seems to reside in the rain forests on the african continent and in the western pacifi c. through the global prevalence of dengue and dengue haemorrhagic fever (dhf) has grown dramatically in recent decades. the disease is now endemic in more than countries in africa, the americas, the eastern mediterranean, south-east asia and the western pacifi c. south-east asia and the western pacifi c are most seriously affected. some million people -two-fi fths of the world's population -are now at risk from dengue. who currently estimates there may be million cases of dengue infection worldwide every year. in alone, there were more than reported cases of dengue in the americas, of which cases were dhf. this is greater than double the number of dengue cases which were recorded in the same region in . not only is the number of cases increasing as the disease is spreading to new areas, but explosive outbreaks are occurring. in , brazil reported over cases including more than cases of dhf. during epidemics of dengue, attack rates among the susceptible are often - %, but may reach - %. an estimated cases of dhf require hospitalization each year, microbial adaptation changes in virulence and toxin production; development and change of drug resistance; microbes as co-factors in chronic diseases of whom a very large proportion are children. without proper treatment, dhf case fatality rates can exceed %. with modern intensive supportive therapy, such rates can be reduced to less than %. the spread of dengue is attributed to expanding geographical distribution of the four dengue viruses and of their mosquito vectors, the most important of which is the predominantly urban species aedes aegypti. a rapid rise in urban populations is bringing ever greater numbers of people into contact with this vector, especially in areas that are favourable for mosquito breeding, e.g. where household water storage is common and where solid waste disposal services are inadequate. rift valley fever (rvf) is a zoonotic disease typically affecting sheep and cattle in africa. mosquitoes are the principal means by which rvf virus is transmitted among animals and to humans. following abnormally heavy rainfall in kenya and somalia in late and early , rvf occurred over vast areas, producing disease in livestock and causing haemorrhagic fever and death among the human population. as of december , who fi gures indicate that the outbreak continues to affect the north western provinces of kenya. in september who documented the fi rst ever rvf outbreak outside africa, in yemen and the kingdom of saudi arabia (ksa). rna sequencing of the virus from ksa indicated that it was similar to the rvf viruses isolated from east africa in . a total of suspected cases were identifi ed, of which ( %) persons died. of the , ( %) cases reported exposure to sick animals, handling an abortus or slaughtering animals in the week before onset of illness. the vibrio responsible for the seventh pandemic, now in progress, is known as v. cholerae o , biotype el tor. according to the who, it continues to spread in angola and sudan; more than cases have been documented with over deaths: a case fatality rate of . - %. cholera (biotype el tor) broke out explosively in peru in , after an absence of years, and spread rapidly in central and south america, with recurrent epidemics in and . from the onset of the epidemic in january to september , a total of cases and deaths (overall case fatality rate . %) were reported from countries in the western hemisphere to the pan american health organization. in december , a large epidemic of a new strain of cholera v. cholerae began in south india, and spread rapidly through the subcontinent (figure . ) . this strain has changed its antigenic structure such that there is no existing immunity and all ages, even in endemic areas, are susceptible. the epidemic has continued to spread and v. cholerae o has been reported from countries in south asia. because humans are the only reservoirs, survival of the cholera vibrios during interepidemic periods probably depends on low-level undiagnosed cases and transiently infected, asymptomatic individuals. recent studies have suggested that cholera vibrios can persist for some time in shellfi sh, algae or plankton in coastal regions of emerging and resurgent infectious diseases infected areas and it has been claimed that they can exist in a viable but non-culturable state. in early , health offi cials in malaysia and singapore investigated reports of febrile encephalitis and respiratory illnesses among workers who had been exposed to pigs. a previously unrecognized paramyxovirus (formerly known as hendra-like virus), now called nipah virus, was implicated by laboratory testing in many of these cases. as of april , cases of febrile encephalitis were reported to the malaysian ministry of health, including deaths. laboratory results from patients who died suggested recent nipah virus infection. the apparent source of infection among most human cases continues to be exposure to pigs. human-tohuman transmission of nipah virus has not been documented. outbreak control in malaysia has focused on culling pigs; approximately pigs have been killed. other measures include a ban on transporting pigs within the country, education about contact with pigs, use of personal protective equipment among persons exposed to pigs, and a national surveillance and control system to detect and cull additional infected herds. nipah virus cases and deaths have also been reported from bangladesh. since then, no more human cases have been reported. sars is due to infection with a newly identifi ed coronavirus named as sars-associated coronavirus (sars-cov). the source of infection is likely to be a direct cross-species transmission from an animal reservoir. this is supported by the fact that the early sars cases in guangdong province had some history of exposure to live wild animals in markets serving the restaurant trade. animal traders working with animals in these markets had higher seroprevalence for sars coronavirus, though they did not report any illness compatible with sars. more importantly, sars-cov-like virus detected from some animal species had more than a % homology with human sars-cov. the clinical course of sars varies from a mild upper respiratory tract illness, usually seen in young children, to respiratory failure which occurred in around - % of mainly adult patients. as the disease progresses, patients start to develop shortness of breath. from the second week onwards, patients progress to respiratory failure and acute respiratory distress syndrome, often requiring intensive care. in may , a -year-old boy in hong kong contracted an infl uenza-like illness, was treated with salicylates, and died days later with complications consistent with reye's syndrome. laboratory diagnosis included the isolation in cell culture of a virus that was identifi ed locally as infl uenza type a but could not be further characterized with reagents distributed for diagnosis of human infl uenza viruses. by august, further investigation with serological and molecular techniques in the netherlands and in the usa had confi rmed that the isolate was a/hong kong/ / (h n ), which was very closely related to isolate a/chicken/hong kong/ / (h n ). the latter virus was considered representative of those responsible for severe outbreaks of disease on three rural chicken farms in hong kong during march , during which several thousand chickens had died. molecular analysis of the viral haemagglutinins showed a proteolytic cleavage site of the type found in highly pathogenic avian infl uenza viruses. by late december, the total number of confi rmed new human cases had climbed to , of which fi ve were fatal; the case fatality rates were % in children and % in adults older than years. almost all laboratory evidence of infection was in patients who had been near live chickens (e.g. in marketplaces) in the days before onset of illness, which suggested direct transmission of virus from chicken to human rather than person-to-person spread. in december , veterinary authorities began to slaughter all ( . million) chickens present in wholesale facilities or with vendors within hong kong, and importation of chickens from neighbouring areas was stopped. knowledge of how humans are infected, the real level of humanto-human transmission, the spectrum of disease presentation and the effectiveness of treatment remains scanty. human-to human transmission is known to have occurred, but there is no evidence that transmission has become more effi cient. all the human-tohuman infections with h n to date seem not to have transmitted on further. therefore, although the case fatality rate for human infection remains high (around % for cases reported to who), it seems that h n avian viruses remain poorly adapted to humans. global prevalence studies (figure . ) indicate that indonesia is currently the most active site of bird to human h n transmission in the asia pacifi c region, and a large number of human cases have been detected here in - . china and cambodia have also reported human cases in . in south asia (india and pakistan), there have only been sporadic reports of infection in poultry to date. in vietnam and thailand there have been offi cial reports of poultry outbreaks; these show a decline since . surveillance in africa is especially weak, and there is evidence of widespread infection in domestic poultry in parts of north, west and central africa. prospects of control are bleak here because of weaknesses in veterinary services, and a number of competing animal and human health problems. the outbreaks in egypt have been well described. these involved both commercial and backyard fl ocks, with considerable impact on economic life and food security. it is probable that large numbers of people in african countries are at risk of h n infection. if that virus had pandemic potential then a pandemic arising from africa must be considered a possibility. non-infectious diseases take an enormous toll on lives and health worldwide. non-communicable diseases (ncds) account for nearly % of deaths globally, mostly due to heart disease, stroke, cancer, diabetes and lung diseases. the rapid rise of ncds represents one of the major health challenges to global development in the twenty-fi rst century and threatens the economic and social development of nations as well as the lives and health of millions of their subjects. in alone, ncds were estimated to have contributed to . million deaths globally and % of the global burden of disease. until recently, it was believed that ncds were a minor or even non-existent problem in developing countries in the tropics. a recent analysis of mortality trends from ncds suggests that large increases in ncds have occurred in developing countries, particularly those in rapid transition like china and india (table . ). according to these estimates at least % of all deaths in the tropical developing countries are attributable to ncds, while in industrialized countries ncds account for % of all deaths. low-and middle-income countries suffer the greatest impact of ncds. the rapid increase in these diseases is seen disproportionately in poor and disadvantaged populations and is contributing to widening health gaps between and within countries. in , of the total number of deaths attributable to ncds % occurred in developing countries, and of the disease burden they represent % was borne by low-and middle-income countries. it has now been projected that, by , ncds will account for almost three-quarters of all deaths worldwide, and that % of deaths due to ischaemic heart disease (ihd), % of deaths due to stroke, and % of deaths due to diabetes will occur in developing countries and the number of people in the developing world with diabetes is expected to increase by more than . -fold, from million in to million in . on a global basis, % of the burden of ncds will occur in developing countries and the rate at which it is increasing annually is unprecedented. the public health and economic implications of this phenomenon are staggering, and are already becoming apparent. it is important to recognize that these trends, indicative of an increase in ncds, may be partly confounded by factors such as an increase in life expectancy, a progressive reduction in deaths due to communicable diseases in adulthood, and improvements in case detection and reporting in the tropics. however, increase in the incidence of these chronic degenerative diseases is real. the complex range of determinants (below) that interact to determine the nature and course of this epidemic needs to be understood in order to adopt preventive strategies to help developing societies in the tropics to deal with this burgeoning problem. the determinants of non-communicable diseases in developing societies are as follows: • demographic changes in population • epidemiological transition • urbanization and internal migration • changes in dietary and food consumption patterns • lifestyle changes (changes in physical activity patterns, sociocultural milieu and stress as well as increased tobacco consumption) • adult-onset effects of low birth weight and the effects of early life programming • infections and their associations with chronic disease risk • effect of malnutrition and nutrient defi ciencies • poverty, inequalities and social exclusion • deleterious effects of environmental degradation • impacts of globalization. four of the most prominent ncds: cardiovascular disease, cancer, chronic obstructive pulmonary disease and diabetes, are linked to common preventable risk factors related to diet and lifestyle. these factors are tobacco use, unhealthy diet and lack of physical activity. interventions to prevent these diseases should focus on controlling these risk factors in an integrated manner and at the family and community level since the causal risk factors are deeply entrenched in the social and cultural framework of society. developing countries in the tropics have to recognize that the emerging accelerated epidemic of ncds is a cause for concern and that it needs to be dealt with as a national priority. they have to learn from the experience of industrialized and affl uent countries to tackle the emerging crisis of chronic diseases that they are likely to face in the near future. the emerging health burden of chronic disease affecting mainly the economically productive adult population will consume scarce resources. it is important, however, to realize that the poorer countries will be burdened even more in the long run, if attempts are not made to evolve and implement interventions to address these emerging health issues on an urgent basis. ensuring that health policies are aimed at tackling the 'double burden' of the continued existence of the huge burden of infectious/communicable diseases alongside the emerging epidemic of non-communicable diseases in developing countries of the tropics becomes a priority. the world we live in is constantly changing. in the past years, we have witnessed signifi cant progress in sustainable and technological development. however, increases in mass population movements, continuing civil unrest and deforestation have helped carry diseases into areas where they have never been seen before. this has been aided by the massive growth in international travel. effective medicines and control strategies are available to dra-matically reduce the deaths and suffering caused by communicable and non-communicable diseases. despite reduced global military spending many governments are failing to ensure that these strategies receive enough funding to succeed. who priorities for the control of infectious diseases in developing countries include childhood immunization, integrated management of childhood illnesses, use of the dots strategy to control tb, a package of interventions to control malaria, a package of interventions to prevent hiv/aids, access to essential drugs, and the overall strengthening of surveillance and health service delivery systems. over % of all preventable ill-health today is due to poor environmental quality-conditions such as bad housing, overcrowding, indoor air pollution, poor sanitation and unsafe water. the challenge of disease in the tropics has continued into the new millennium -never before have we been so well equipped to deal with disease threats. it remains for humankind to summon the collective will to pursue these challenges and break the chain of infection and disease. national and international surveillance of communicable diseases health report: fighting disease fostering development. geneva: world health organization acute respiratory infections. geneva: world health organization indoor air pollution energy and health for the poor estimate of global incidence of clinical pneumonia in children under fi ve years the global burden of diarrhoeal disease number evl- - . a global review of diarrhoeal disease control new parameters for evaluating oral rehydration therapy: one year's experience in a major urban hospital in zaire symptomatic hyponatremia during treatment of dehydrating diarrheal disease with reduced osmolarity oral rehydration solution diarrhoea mortality in rural bangladeshi children for the human rotavirus vaccine study group. safety and effi cacy of an attenuated vaccine against severe rotavirus gastroenteritis guidelines for the control of epidemics due to shigella dysenteriae . publication no. who/cdr/ . . epidemiology of dysentery caused by shigella. geneva: world health organization global tuberculosis control-surveillance, planning financing, geneva: world health organization who/international union against tuberculosis and lung disease global project on anti-tuberculosis drug resistance surveillance. epidemiology of antituberculosis drug resistance (the global project on anti-tuberculosis drug resistance surveillance): an updated analysis geneva: world health organization climate, ecology and human health global burden of disease and risk factors. geneva: world health organization update: global measles control and mortality reduction -worldwide towards the elimination of hepatitis b: a guide to the implementation of national immunization programs in the developing world. the international task force on hepatitis b immunization. geneva: world health organization global control of hepatitis b virus infection tetanus in developing countries: an update on the maternal and neonatal tetanus elimination control of neglected tropical diseases (ntd) incorporating a rapid-impact package for neglected tropical diseases with programs for hiv/aids, tuberculosis, and malaria emerging infectious diseases review of state and federal diseases surveillance fact sheet: ebola haemorrhagic fever. fact sheet no. . geneva: world health organization report of the public health laboratories division. who collaborating centre for research and training in viral diagnostics national institute of health update: vibrio cholerae o -western hemisphere, - , and v. cholerae o -asia update: outbreak of nipah virus: malaysia and singapore sars and emerging infectious diseases: a challenge to place global solidarity above national sovereignty world avian infl uenza update: h n could become endemic in africa global strategy for the prevention and control of non-communicable diseases. geneva: world health organization global comparative assessments in the health sector. geneva: world health organization life in the st century: a vision for all. geneva: world health organization life course perspectives on coronary heart disease, stroke and diabetes: key issues and implications for policy and research diet and life-style and chronic non-communicable diseases: what determines the epidemic in developing societies? in: krishnaswami k, ed. nutrition research: current scenario and future trends the double burden of communicable and non-communicable diseases in developing countries key: cord- -njeewhv authors: ryu, jaewon; russell, kristin; shrank, william title: a flower blooms in the bitter soil of the covid- crisis date: - - journal: nejm catal innov care deliv doi: . /cat. . sha: doc_id: cord_uid: njeewhv the pandemic offers many lessons and reaffirms the value of innovations we had been reluctant to pursue. examples abound, and the remarkable pace of progress has been a bright spot amidst the tragedy. in addition to celebrating this, we should think proactively about whether there are lessons that we can apply to other health care challenges. although the need to decrease costs and waste in the health care system lacks the drama and immediacy of the current crisis, it is more essential than ever that we do this, and that we do it quickly. solving these issues has been a formidable challenge that will require the type of rapid and robust innovation we have seen during this crisis, and understanding the conditions that created such fertile ground may help us cultivate these similar conditions post-crisis. the primary driver of innovation during this crisis has been the urgency and common enemy that mobilized and united us. at the outset, reputable models projected millions of deaths would occur if we did not intervene. there was an urgent need to act and we responded by implementing unprecedented public health measures that resulted in % of americans being subject to stay-athome orders. similarly, there have been crises in the past that have mobilized the world to innovate in surprising ways. the desire to beat the ussr during the space race in the s mobilized the country to achieve something that would have seemed impossible, and the internet was invented as a contingency plan if phone lines were destroyed by the ussr during the cold war. urgency with shared purpose are indeed powerful forces. the massive infusion of flexibility into the traditionally rigid health care industry removed barriers to innovation. the policy changes that were made by the federal government had immediate and cascading impact. some of the most transformative included the sweeping centers for medicare and medicaid (cms) waivers that expanded access to telehealth, provided flexibility for member cost-sharing, facilitated advanced payments to providers, and loosened regulatory requirements for skilled nursing facility coverage. similarly, state governments added additional flexibility with actions like modifying licensure requirements to allow providers to cross state lines to meet surging capacity demands quickly. providers themselves raced to offer flexible care options, many moving to telehealth-only practices within days and some offering "porch visits" as a halfway step between in-office and in-home visits to decrease transmission and need for personal protective equipment. to spur creativity and speed, yet we rarely see these principles evoked on such a large scale and with such high stakes as we have seen with the covid- crisis." finally, health plans made far-reaching changes like waiving utilization management and covering all costs related to covid- testing and treatment. at humana, an interesting benefit of this action was the ability to retrain nurses who had been doing utilization management to make proactive outreach calls to members to address their crisis-related needs. likewise, at geisinger, nurses who had been doing preventive screening outreach calls were able to shift gears to also perform outreach check-in calls to those patients who tested positive for covid- and were recovering at home, and by monitoring disease symptoms and advising if in-person evaluation appeared necessary. by necessity, we have also seen another type of flexibility during the crisis: an increased tolerance for creative solutions that are imperfect or untested. entrepreneurs encourage principles like "test and learn" and "fail fast" to spur creativity and speed, yet we rarely see these principles evoked on such a large scale and with such high stakes as we have seen with the covid- crisis. it has been remarkable to witness the numerous examples of makeshift and unorthodox solutions that have been applied to truly complex problems -from creating a hospital in new york's central park to repurposing empty hotels to house the homeless. innovations have led to important learnings; " for instance, when cms began allowing audio-only telehealth interactions, we learned that many seniors much preferred this option as it avoided the embarrassment they felt at the idea of providers seeing inside their homes. while the absence of systems-based thinking among stakeholders in the industry has stalled progress in the past, this crisis has highlighted the critical importance of collaborating and has spurred surprising new partnerships that should give us hope. the entire covid- genome was sequenced in a day and published online through a large-scale international collaboration, and the "accelerating covid- therapeutic interventions and vaccines" partnership between national institutes of health and multiple pharmaceutical companies has provided a compelling example of the public-private partnerships that have been a prominent theme of this crisis. we are also seeing remarkable examples of competitors who are now collaborating, such as apple and google combining forces to develop a contact tracing platform. another striking example arose when new york essentially merged all hospitals in the state into a single operating body to enable supplies and capacity to be rationally and nimbly allocated. covid- is the quintessential example of the way that public health interventions can extend the reach and efficiency of our existing health care system. months ago, it would have been hard to imagine a situation that could have mobilized millions of americans to pay avid attention to key epidemiological principles. yet, phrases like "flatten the curve" and "slow the spread," are now part of our everyday vocabulary and our children are playing "social distancing" with their dolls. millions tuned in every night to watch the white house task force (including the infectious disease expert turned cult-hero anthony fauci) use slides and pointers to explain the intricacies of hospital capacity, testing algorithms, and risk stratification. laser-like focus on the allocation of scarce resources has required us to think about the needs of the whole population more than ever before. we have been forced think about the needs of the whole population more than ever before and that has drawn attention to these issues and helped us develop the vocabulary to discuss them. it is this population-level lens that will be required to truly transform our health care system." we are seeing this public health influence throughout the system, from sophisticated models that predict the impact of prevention measures to a sharper focus on allocation of scarce resources like personal protective equipment and icu beds using robust, new risk stratification and triage processes. we have been forced think about the needs of the whole population more than ever before and that has drawn attention to these issues and helped us develop the vocabulary to discuss them. it is this population-level lens that will be required to truly transform our health care system. " alignment, flexibility, collaboration, and a public health lens have enabled rapid progress ( table ) . as important as this progress has been, many more changes are still needed, and we must be deliberate about how to achieve them. it is notable that the conditions that allowed for this rapid change to occur overlap substantially with the conditions created by value-based payment models. in fact, in many ways, these models are specifically designed to create these dynamics. in addition to the urgency, part of what made the covid- crisis such fertile ground for innovation was the shared mission. one of the issues with the legacy fee-for-service model is that it fails to align stakeholders. fee-for-service providers are reimbursed based on the volume of care they provide. providers benefit by increasing volume and, as a consequence, payers (whether employers, health plans, or the government) lose. despite the best of intentions, this design inadvertently thwarts innovations that decrease waste by impacting volume. in contrast, providers in value-based care arrangements share risk with payers, and both benefit when high-quality care can be provided for a lower cost. value-based payment models provide stability and predictability in income, offering providers far more flexibility than the traditional fee-for-service models. because providers in value-based payment environments are not constrained by the need to maximize the volume of care, they have the freedom to experiment with novel ways to reduce costs and improve outcomes. for the most part, providers can choose how to do this, which encourages creativity and allows for a "test and learn" mentality that is necessary for innovation. the money saved can increase take-home compensation and can also be invested into the practice in ways that can further increase efficiency, creating a virtuous cycle that further fuels innovation participants in value-based payment relationships must collaborate to be successful. for example, payers can help providers identify which patients have social challenges like food insecurity and loneliness and connect them with resources that help close these gaps. in this elegant arrangement, both payer and provider benefit when patient outcomes improve. to enable true transformation of our health care system, we must shift to thinking about wholeperson health on a population level. by design, this thinking is required in value-based payment relationships where providers are financially responsible for the health of their entire panel, or "population," of patients. as such, providers must think about how to engage patients who are coming for care, and also those who may not be. because social determinants like food insecurity have such an impact on health outcomes, providers are more attuned to the "whole patient" in these models. we must accelerate our efforts to reduce costs while improving care, and value-based payment models are best positioned to do this. models that provide predictable payment may be particularly appealing to providers struggling in the current environment. there is both urgency and opportunity right now, and it is critical that we seize this opportunity and act quickly to prioritize policies that encourage and enable value-based care relationships. as we have seen with telehealth policy, tactics that increase flexibility can rapidly accelerate positive change. now is the time to consider which changes (e.g., telehealth waivers, state licensing modifications, etc.) should become permanent and to think proactively about adding new flexibilities that might drive change, particularly in areas like social determinants of health and behavioral health where there are immediate, pressing needs. other high-priority policy areas include figuring out how to reimburse for remote monitoring, considering the idea of adding social risk scores to risk adjustment methodologies for payment and quality measurement purposes, allowing stars performance measures to be attained virtually, and removing outdated anticompetitive barriers like state certificate-of-need laws. the trends that emerge from this crisis will define health care for many years, and our ability to anticipate and shape these trends is essential. to do that effectively, we need to be avidly collecting, analyzing, and sharing data now. for instance, by measuring the shifts in utilization during this crisis (e.g., telehealth utilization by patient demographics and provider type), we can better understand the impact of type and site of care more generally. correlating utilization with health outcomes is also critical; for instance, many providers were reluctant to adopt telehealth before the crisis because of fear of decreased quality of care, and understanding telehealth-related outcomes can help address this. the covid- crisis has caused morbidity, mortality, and worldwide economic and social disruption that will impact us for generations. even before this, with costs soaring, waste rampant, and the increasing prevalence of chronic conditions, the health care industry was in dire need of transformation. pre-crisis, the animosity and sense of futility amongst stakeholders in the health care system created real barriers to change. the urgency of the current crisis has mobilized the united states to align and cooperate in new and flexible ways that leverage public health principles. the collaboration and ingenuity we have seen during this crisis should give us hope that we can make progress on issues that have seemed intractable, and transitioning to value-based payment models will help to create the conditions and alignment we will need to act. survey: physician practice patterns changing as a result of covid- us virtual care visits to soar to more than billion key: cord- - v aukg authors: tognoni, gianni; macchia, alejandro title: health as a human right: a fake news in a post-human world? date: - - journal: development (rome) doi: . /s - - - sha: doc_id: cord_uid: v aukg based on a synthetic overview that embraces the evolution of the ‘health’ concept, and its related institutions, from the role of health as the main indicator of fundamental human rights—as envisaged in the universal declaration of human rights—to its qualification as the systems of disease control dependent on criteria of economic sustainability, the paper focuses on the implications and the impact of such evolution in two model scenarios which are centred on the covid- pandemia. the article analyses covid- both in the characteristics of its global dynamics and in its concrete management, as performed in a model medium income country, argentina. in a world which has progressively assigned market values and goods an absolute strategic and political priority over the health needs and the rights to health of individual and peoples, the recognition of health as human right is confined to aspirational recommendations and rather hollowed out declarations of good will. the title of an article where a question mark follows a provocative statement could easily sound as a rhetoric artefact rather than the formulation of a real research hypothesis. to provide a clearer answer to this doubt, and a full justification of the legitimacy and relevance of the question mark, let's start with a few preliminary considerations and explanatory notes, which we deem necessary as a general conceptual and methodological framework. here they come, in this logical sequence: • the two domains associated and confronted in the question posed in the title-public health and human rights-have been the long-term professional field of the authors. both of them have been engaged mainly in intense research activity related to field projects and thematic areas where they have directly crossed, and experienced, the often conflicting tension and interaction between the point of view of 'health' as a fundamen-tal human and peoples right, and that of 'health' as an increasingly dominant component of market rules. since the seventies, model health areas have included drug policies such as the who essential drugs, innovative population clinical trials, critical epidemiological use of large databases, normative regulations of accessibility to health technologies (tognoni et al. ) . a parallel line and a different type of research that both authors have conducted has focussed on the causes and consequences of massive violations of peoples' rights. their cumulative experience, derived from the insides of these most diverse scenarios, has provided them with a solid confirmation of what has emerged with a growing consensus also in the most prestigious 'scientific' literature, in the last years: structural inequality is the direct product and the expected outcome of the mainstream models of development, which trigger a highly visible impact on the rights to health and life, and prove to be a systemic source of in-human levels of inequity (evans ). • the title of the important book from indian academic baxi ( ) which has inspired the question mark of our contribution has proved to be neither a pessimistic forecast nor a philosophical theoretical generalization of trends on the eve of this century's first financial crisis. health, the most sensitive indicator of the right to human dignity, has become the arena of a most impressive cultural transformation. it is the terrain that best documents the level of inequalities-iniquities generated by assuring the privilege of priority attributed to goods over humans in economic profit oriented legislations. this terrain is also an inevitable object of observation and analyses, where humans and their lives are normal, expected, quantifiable 'victims', and not inviolable subjects (for a very careful documentation of the broader evolution in this direction of juridical and institutional international scenarios (dentico ). • an independent and enriching integration of baxi's view (with an impressive documentation from real life sociological contexts, populations, outcomes) is provided in saskia sassen's book which gives a most effective definition of the whys and hows of the post-human qualification. the globalization project hinges on rigid logistic and economic supply chains for whatever may be considered a market good-anything that generates profits in the selling and buying universes, including humans. the expulsion of whatever claims to be, or may be assumed to be, a 'subject' endowed with inviolable life and dignity rights (as opposed to a marketable object), is a mandatory and automatic reaction of the algorithms guiding the decisions (sassen ). • the last viewpoint that concludes this introductory framework is the most unexpected, hence the most significant one: for its peculiar origin, its world vision, and indeed its language. we refer to pope francis's two last encyclical documents, widely recognized as the expression of a truly 'universal' conversion, not confined by religious walls or political frontiers. the pope's letters envisage humankind's re-positioning in its one and common home, that being creational nature. his approach marks an innovative recuperation of the principles of fundamental rights, which cannot be but oriented to the full inclusion of all humans (migrants, marginalized, etc.) as subjects entitled to the same dignity of life and wellbeing-which accessible health is a concrete indicator of. our attempt here is to try and provide a synoptic view with some interpretative lights on the events and/or documents that have given substance to a long history. in table we intend to portray the chronology and the core themes that allow a comprehensive understanding of the challenges that we need to face in today's political, economic, conceptual scenarios while looking for an answer to the questions about the state of the right to health raised in the title of our article. the narrative of the long list's contents aims to underline the continuity and the articulation of a process where the role of the same actors (international agencies, national governments, representatives of civil society and people's movements), and their reciprocal hierarchy of power, have mutually evolved to shape the time we are living. as the first un operational agency created even before the proclamation of the universal declaration of human rights (udhr), the who was regarded as the immediately available, concrete and easy-to-grasp instrument to advance the political agenda of the new era, after the plight of two world wars: the human right to life and dignity could be seen and promoted as truly universal, if accessibility to the right to health could be secured. the vision then was pinning down the world to translating a declared universal principle-the right to health-into effective policies and visible practices in the context of the different countries, whose national constitutions were meant to convert the udhr principles into a daily experience. this horizon did not last long. less than years after the udhr, the perspective of the linear development of a democratically organized society had substantially changed already. the udpr turned out to be promoted as an independent charter to reflect and clearly denounce the dramatic limitations of the existing international law. it did not take long for the international community of states to progressively become the expression and the vehicle of 'strategic'-economic, military, political-interests, a scenario in which the multinational corporations had been playing an increasing role while denying any loyalty or accountability to the udhr principles, and their implications. the world health organization (who) soon became well aware of the mounting threats to its authority and field of competences, under the guise of a rapidly growing health market deprived of any control. the agency did not stay idle, in the face of what was coming. a very restricted list of 'essential drugs', based on the consensus of the scientific community, was formulated and proposed for approval to the who member states. the idea was to equip governments with a tangible as well as symbolic tool to resist the pressure stemming from the neoliberal development models that mainly the international monetary fund (imf) and the world bank (wb) had started to impose. the first half of the s coincides with a major cultural and institutional translation, in the arena of health, of the shifts that had occurred to the original udhr paradigm. the newly born world trade organization (wto) declares its exclusive competence on health goods, technologies and structures. in a nutshell, the trade agenda asserts itself as the new overarching normative regime. in alliance with the who, the wb draws a new map of health priorities where investments should concentrate. the map does not set its priorities on the assessment of real unmet needs. it is designed on the tricky notion of the global 'economic burden' of the individual diseases (gbd), now the main-if not exclusive-term of reference of health market costs and provisions, accessibility trends, international procedures. contrary to many expectations, the newly established international criminal court (icc) declares its juridical incompetence and lack of mandate on the 'new' crimes against individual and peoples' rights committed in compliance with the new economic and trade laws. in the narrative of the acronyms for the new millennium, health appears as one of the main goals to be pursued. yet, the health goal is placed in a generic framework of socioeconomic variables and featured with the profile of an insurance scheme for which somebody should pay. isn't this what the acclaimed universal health coverage (uhc) approach ultimately aims for? the ambivalence, the limits, and the remarkable failures of these top-down global goals are too well known across the research reports or the administrative reviews of concerned agencies and disciplines, to require any further comment. conversely, the silence of the scientific and institutional literature on the who-sponsored report on the social determinants of health (sdh), is indeed very meaningful. the sdh report was supposed to remind the world, renew the memory, relaunch the era of the 'health for all' (hfa) culture and its mobilizing manifesto, the alma ata declaration. this reticence is a confirmation of how deeply the normative and epistemic changes have been interiorized. no space is left for a terminology reminiscent of the 'human' in the global reporting or goal setting, anymore. the semantic oblivion had been knowingly experimented through the gbd methodology, whose main focus is the geo-mapping of health economic burdens. the iteration of strictly descriptive and repetitive data on the growing notavoidable levels of inequalities-inequities has paved the way to the planned disappearance even from the dictionaries of health rights disciplines (abassi ) . the often announced but substantially unexpected covid- pandemia has produced a more than foreseeable confirmation: the statistics of mortality made available for all the affected countries reproduce similar gradients of excesses of contagion and deaths which overlap and add to the underlying conditions of inequalities. a structural and pandemic characteristic featuring high income countries (hics) just as well (swenor ) . it is not the purpose of this article to either summarize or comment the rapidly changing data related to covid- . the main issue is rather the degree of credibility the multiple actors in the pandemic landscape-the un agencies, the european commission, religious leaders, academia, ngos representing civil society, the concerned corporate actors, the science community-have vehicle through their institutional positions. the uniquely symbolic power of what has happened, its extension and consequences, cannot leave reality as it is. radical changes in development modelling must be prepared, different hierarchies of values need to be adopted. unfortunately, as often if the case, power balance evolution does not seem oriented to seriously engage with the challenge of radical modifications. the field of health appears to be a case in point, for its specific perfect reproduction of 'wishful thinking' strategies. a tentative check list of challenges and priorities made visible by covid- would be useful. the first and most impressive 'discovery' triggered by covid- is the structural fragility of a system of marketdriven supply chains-of goods, knowledge, information, data. in the first two decades of the twenty-first century these supply-chains appeared to be the solid and untouchable protagonists of the global development models. until the arrival of a biological agent, doomed to be under global knowledge's tight control, has successfully revealed the inherent ignorance and deep fragmentation defining the various branches of the most advanced disciplines of basic sciences: public health, epidemiology, health technologies. possibly, the unpreparedness to ignorance, in a global culture increasingly confident on the power of technology and the linearly conceived algorithmic decision-making, has produced a decisive worsening of the pandemic impact. a world proud of its digital capacity of 'linking' and 'sharing' has discovered its communication failure when it comes to real risks and potential solutions, as well as its cultural carelessness, its political and scientific lack of foresight when it comes to sharing data on unmet needs and possible solutions. globalization's top-down approach has proved highly ineffective, 'lost in translation', when devising the needed strategies for collaborative involvement of human beings. classical health security measures (certainly needed) have been the only remedy put in place with great variability, and unmeasurable/incomparable results in different countries and health systems. which has entailed a recognized negative impact on the democratic and health rights of ordinary citizens, not to mention the enhanced precariousness of migrants, refugees, uninsured, homeless, simply 'poor' or marginalized people, across the world. the acclaimed capacity of handling and relying on big data to monitor, anticipate, measure the yield of the (often more than controversial) interventions has produced an international situation of confusion and uncertainty in the epidemiological understanding, and evaluation, of the pandemic evolution. scientists and health authorities have simply failed to agree on reliable and applicable criteria for comparing their data. the retraction of scientific reports from major specialized journals, the breach of fundamental rules and practices of independent results' evaluation, even in regulatory agencies, the virtual lack of any formal coordination of public health efforts months after the inception of the 'emergency' are known elements of the daily chronicle we have familiarized with, and abundantly so. in this scenario, the only recognized exception concerns health professionals. confronted with the human face of the pandemic, close to the solitude of human bodies unable to breathe, medical doctors, nurses, health personnel have assured an impressive quality of presence and intensity and care across the spectrum of the different given settings. they have done so mooring their unexpected and extraordinary experience to the safe bay of the old robust-albeit tragically neglected-value of medicine as a science and practice that is grounded on a rigorous combination of professionalism, solidarity, ethics. it is reasonable to say that this 'care for humans'-often institutionally unplanned, hardly politically supported, at risk now of being forgotten in terms of participation to the overall planning for the future-has been the only positive, authentic, understandable, credible form of communication to the public opinion. the other significant consensus is that health systems had suffered greatly during the pandemic crisis due to the sharp reductions of investments in human resources and community strategies, imposed by 'economic sustainability' criteria. the scenario we have tried to summarize, therefore, bear witness to the fact that the global challenge introduced by the covid- is only very partially a health problem. the ongoing economic, political, juridical 'wars' currently surrounding the narratives about the development, distribution and accessibility of the covid- vaccines are, yet again, a most worrying confirmation of the real question for our societies today: namely, what model of civilization will be chosen after covid- (bloom et al. ; nowak et al. ). humans-their lives and their values of democracy, solidarity, and hope for a better future-have played their role as victims, rather than as subjects. the viral pandemic has disclosed the structural pandemic impact of the social and economic viruses that have infected the global chains of knowledge production, denied the possibility of delivering the common goods, seconded the vested priorities of private powerful minorities over the vast majorities of peoples. the most recent reports from the gbd groups have 'discovered' that the global data which consistently document the extent and the severity of the impact of the inequalities worldwide should evolve from a strategy of neutral description into one approach of looking into the avoidability of such inequalities-iniquities. it seems an obvious cultural and methodological change, but it could represent quite a revolutionary step forward from the tragically impressive analytical model illustrated by burstein et al. in a top scientific journal ( ). a substantial proportion of the million neonatal, infant, paediatric deaths occurred in the twenty-first century could be considered avoidable with simple, mainly non-sanitary measures, the study says. nothing else. ultimately, there in an urgent need for re-establishing human lives and deaths as the measure of needs and outcomes, against the persistently dominant focus on disease burdens. repeating the usual soliloquy of 'international' literature, an abundant production of medical articles has flooded physicians and public health professionals working in the global south with the intent of explaining them what is happening in their countries, what their needs are, what lessons they should learn from the covid- pandemic. while the flow of information is meant to be educational, the appropriate term we can use is, possibly, indoctrination (daniels ; hogan et al. ; walker et al. ) . with covid- , a new wave of top-down, complex and unverifiable mathematical models keep coming from the center of the world foreseeing when the peripheries will run out of respirators, how many people will die in the next semester, how the pandemic will impact tuberculosis and hiv infected people (walker et al. ) , and how all this knowledge should inform a model of healthcare organization (walker et al. ) . all data must be noted and lessons learnt. this dynamic was not brought in by covid. for decades, centrally produced guidelines have indicated how to invest mostly borrowed money for the 'proper' administration of health resources. to verify the sparkle of the truth hidden in the lies, a small, basic technical frame of reference could be useful to discuss concepts related to solidarity, rights and autonomies of real populations. for decades now (world bank ; murray and lopez ; cooper et al. ; jamison et al. ; mathers and loncar ) , gbd reports have informed us that in argentina things are going reasonably well. the increase in life expectancy, the decrease in infant mortality and the overall improvement in access to healthcare (haq index) indicate that things have improved significantly. the institute of health metrics (its logo explicitly states: 'measuring what matters') incorporates comparisons with other countries to provide a reference aimed at defining the magnitude of trends and problems. this approach makes argentina indistinguishable from bosnia and herzegovina when it comes to deaths from cirrhosis, although it would profile it better than china in terms of self-inflicted injuries and significantly worse than the mauritius islands of east africa in neonatal conditions. this is a description of what is published. beyond the international metrics and their grotesque comparisons, these estimates lead to an important conceptual distortion. when analyzing argentina's factual data, we see that the average improvement occurs at the expenses of a fraction of the population. inequity increases and access to services worsens among those who need it most (macchia et al. forthcoming). women, for example. their health situation is dramatic. available data from the last years show that in - argentinian women have the same standardized death rate as in - . premature mortality increases significantly among the poorest segments of society, and does so with particularly harsh trends among women over (macchia et al. forthcoming ). yet, these populations disappear completely from the health metrics analysis. their eclipse is not accidental. the categorization of a wide, polychromatic and heterogeneous universe into smaller, measurable, homogeneous fractions recording an average improvement, manages to reduce the world to estimates showing some improvement but leaving out immense population groups (sassen ) . the resulting disappearance of humans portions shrinks the world to a selected group of inhabitants, those who coincide with as many given categories or clusters. the covid is a chapter written with the same letters. the grotesque comparisons and 'rankings' among countries circulated by the media on a daily basis, arithmetically counting the number of sick and dead, only represent the further trivialization of a culture that does not pretend to learn or listen but to talk. in a world where many could know so much, the number of people who know something seriously is alarmingly low. again, a few technical data to reflect on this. in buenos aires, a city of . million people, the cumulative incidence rate (ic %) of covid- was covid- was ( covid- was - per , people, as of august . in the slums it was ( - ) corresponding to , people, while in the city areas not inhabited by proximity to the slums it was ( - ) corresponding to , people. despite their younger age, slum dwellers have a significantly higher mortality rate. even disaggregating by age, sex and risk factors, the mortality rate of slum population doubles that of people living outside the slums (macchia et al. submitted) . ultimately, covid- , like coronary disease, tuberculosis, malnutrition, obesity and cancer (marmot ) is socially conditioned. additionally, the possibility of confining cases and close contacts in overcrowded housing is close to zero. in buenos aires more than % of covid-related cases among slums dwellers had to be confined to alternative care sites (hotels). what's the point of describing covid in argentina merely counting the number of cases, without telling people's stories, without understanding the different human groups, their identities and challenges? it seems that global world standards do not need this information. after all, slum dwellers are not part of the global picture, just like the over one billion world inhabitants who live undocumented (byass et al. ) , and who spend their lives in daily statistical and political anonymity. health has ceased to be a public matter since years. it was regarded as such for a brief period of political history, a time that cannot return it seems, at least not in the short term. but it is not only the administration of health care that has been transferred into private hands. public health research and its priorities setting is in private hands, too. philanthrocapitalism, particularly through the bill & melinda gates foundation, finances the research agenda and modulates collective health's decisions at the level of the multilateral community. members of 'philanthropic' foundations have close ties to pharmaceutical companies, so they sail from private interest to public policymaking with no restraints. philanthropic foundations' staff sits on corporate entities' boards and public health organizations alike, as if this were a normal circumstance (birn ) . in covid's case, the relationship between the director of the 'warp speed' programme and his relationship with one of the candidates to produce the vaccine is one point in case. example. the relationship between health, collective rights and market interests has become increasingly blurred. some latin american countries hailed the vaccine production in their own territories, announcing it as the exercise of state responsibility for the benefit of collective health. but this narrative is nowhere close to reality, at least in argentina. the production of the astrazeneca and the oxford university vaccine was entrusted by the consortium to an argentine businessman who owns a group of transnational companies. the business group quickly clarified that this is an 'agreement between private parties' and that the argentinian state has nothing to do with it. in fact, the argentinian state does have a role. it has secured the advanced purchase of tens of millions of doses without even negotiating the price of the product. it takes the risk of vaccinating early, in the absence of long-term safety monitoring results. but there's more. in the past, the government has financed the vaccine production plants. the state is indeed playing a role with a variety of interventions, including that of a consumer. the race to win the market competition encouraged by ignorant politicians with no scruples is doomed to produce even greater damage (krause et al. ) . obtaining a poorly effective vaccine (as it will most likely be the case for the first generation of products) will generate a gold standard that other follow-on trials will adopt as their benchmark. in , martin heidegger envisaged what did not exist then, but we must consider today: 'when the farthest corner of the globe has been conquered technologically and can be exploited economically; when any incident you like, in any place you like, at any time you like, becomes accessible as fast as you like; when you can simultaneously 'experience' an assassination attempt against a king in france and a symphony concert in tokyo; when time is nothing but speed, instantaneity, and simultaneity, and time as history have vanished from all being of all peoples; when a boxer counts as the great man of a people; when the tallies of millions at mass meetings are a triumph; then, yes then, there still looms like a specter over all this uproar the question: what for?-where to?-and what then?' the substantial convergence between the initial question of our title and the questions that heidegger formulates in the quote we have chosen could be seen as the most coherent and certainly worrying conclusion. the historical parenthesis when the universality of human rights was politically adopted not as an utopia, but as an innovative (first in history!), concrete, long-term programme of a post-war (never again!) world order is radically threatened, if nor formally declared obsolete. the ongoing covid- event is the symbolic-even more importantly than the real-expression of a time when unmet needs and questions come forcefully to the fore as protagonists, higher and above the accepted challenge. health was the first ideal and realistic proposition of that historical parenthesis (table ) : the life with dignity of human beings (no one left behind!) was assumed to be the mandatory, reasonable, long term outcome. but the amazing successes of life sciences in the last decades have moved in parallel with the progressive transformation of the economy from a valuebased, competent science that guided the use of resources as a key component to support human development, into an autonomous uncontrolled power. the legitimate and binding indicators of human and peoples' rights were marginalized, to the advantage of development models and economic strategies, whereby market goods acquired the status of free and untouchable subjects of legal contractual laws. on the other hand, most juridical sciences and institutions, satisfied with the formal solidity of their principles, conventions and constitutions based on universality paradigms, became confined to a role of arbiters and controllers of the new global order 's compliance. in this scenario, the universality of human and peoples' rights was progressively transformed into a dependent variable of economic sustainability and of the impunity needed by the new political and on october , the minister of health has assured that in march a massive vaccination campaign will be carried out in argentina with the astra zeneca vaccine, the production of which is planned in argentina available at https ://www.lanac ion.com.ar/polit ica/coron aviru s-argen tina-gines -gonza lez-garci a-en-marzo -nid . economic powers, active at the national and international level. the pandemic, triggered by one of the oldest companions-enemies of human life and history, could become a determinant of a cultural, social, mental lockdown; a test of the limits of resistance of societies, more than a powerful stimulus of resilience. as representatives and disenchanted actors of disciplines where uncertainties and failures compel to imagine, promote, experiment answers 'to care for the right of life'-this indeed has been the only recognized 'light' of engagement in the dark tunnel of the pandemicwe have the duty to give our last question an horizon. something that does not exist but has a very important role, as eduardo galeano showed in his imagined upside-down world. the role of the horizon is simply to oblige us to move on and go ahead. let's at least be the custodians, let's at least preserve the memory of the utopia of the first acronyms in table . the universal right to life in dignity is assumed in a bottom-up mobilization by the subjects of history, the 'discarded', the expelled majorities, as a priority area of high cultural and social conflicts, to become the political terrain of struggle and confrontation with the economic and institutional powerful minorities, in the quest for a new, human, parenthesis. it is our horizon. not an answer. health inequalities: death by political means philanthrocapitalism, past and present: the rockefeller foundation, the gates foundation, and the setting(s) of the international/global health agenda when will we have a vaccine? understanding questions and answers about covid- vaccination mapping million neonatal reflections on the global burden of disease estimates disease burden in sub-saharan africa: what should we conclude in the absence of data? covid- cases surge in colombia nutrition, pathologies of power and the need for health democracy health equity: are we finally on the edge of a new frontier? potential impact of the covid- pandemic on hiv, tuberculosis, and malaria in low-income and middle-income countries: a modelling study disease control priorities in developing countries covid- vaccine trials should seek worthwhile efficacy doval. forthcoming press. an analysis of death trends in argentina covid- among the inhabitants of the slums in the city of buenos aires: a population based study social determinants of health inequalities projections of global mortality and burden of disease from the global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries and risk factors in and projected to pandemic influenza vaccines: communication of benefits, risks, and uncertainties expulsions: brutality and complexity in the global economy meeks lm, disability inclusion. moving beyond mission statements embedding patient-and public health-oriented research in a national health service: the gissi experience the impact of covid- and strategies for mitigation and suppression in low-and middle-income countries key: cord- - me authors: holland, caroline title: why prevention must be targeted, creative and multi-faceted date: - - journal: bdj team doi: . /s - - - sha: doc_id: cord_uid: me nan than fantastic. we have done a lot of learning but our motto was "every problem has a solution". it's about making sure that parents and carers had a voice and doing what we can to make a difference to the children of greater manchester. 'until covid- , we had , children toothbrushing on a daily basis. since covid- , nobody has disengaged. ' with dental practices and many early years settings closed, jo described how everyone involved in the programme did what they could to ensure children still got their toothbrushing packs. using voluntary services, food banks and aid workers, they wanted every child who needed a pack to get one. forty thousand, two hundred and seventeen packs were distributed when the pandemic was at its height. another important aspect of their work is to engage with health visitors and ensure they are training to deliver key oral health messages to new parents. once the pandemic was underway and health visitors could no longer go out to parents' homes or provide clinics, the team worked with midwives. they also distributed -electronically -the videos made by the british society of paediatric dentistry and brush dj with dr ranj in the pandemic. another area of the country where flexible commissioning has been embraced is in north yorkshire and humber. as in manchester, programmes are geared to funding gdps to provide prevention as well as building links between dental practices early years settings and health visitor and social care teams. the beauty of the flexible commissioning approach, according to simon hearnshaw, the chair of the local dental network, is that there is no additional cost. the region's in practice prevention programme uses trained dental nurses to deliver patient-centred evidence-based prevention pathways targeted at children who have dental decay or are being referred for ga extraction. simon said: 'in simple terms, the flexibly commissioned resource pays for the ringfenced time to deliver key messages and interventions and to encourage and support behaviour change. over two and a half years more than , targeted one-to-one prevention appointments have been delivered to children with disease. ' he has been working with ingrid perry, a practice manager at a mydentist practice in hull and one of the urgent dental care centres during the pandemic. she is helping to devise a toolkit to support the training of oral health educators in mydentist practices who will be part of the fc initiative. devolved health and social care partnership, allowing professional teams to advance their own strategies via managed clinical networks. these professional groups, in which clinicians and commissioners work together to ensure services meet the needs of local populations, are well established, including for paediatric dentistry. in , the dental community in greater manchester announced its ambitious vision for change. gdp mohsan ahmad, chair of the local dental network, wrote the foreword to a document setting out the three-year plan, stressing that dental teams would play an essential part, by engaging communities to value good oral health, driving improvement in outcomes. if all goes according to plan, flexible commissioning across greater manchester should result in a number of practices being accredited as child friendly dental practices. they will be expected to carry out the locally developed baby teeth do matter online training and provide evidence-based treatments, such as placement of preformed metal crowns using hall crowns or silver diamine fluoride (sdf) application in order to arrest caries and reduce the number of children being referred into secondary care for extractions. if this was a good idea a few years ago, it's essential now that secondary care appointments are in such high demand. the dental check by one campaign, recently reinvigorated by the british society of paediatric dentistry, is also central to an accredited child friendly dental practice. in january of last year, the greater manchester health and social care partnership (gmhscp) launched a £ . million programme to reduce dental decay. jo dawber is the gmhscp project manager for oral health transformation under the leadership of consultant in dental public health, emma hall-scullin. social challenges are considerable in greater manchester which has four of the national priority areas set out in starting well: a smile life initiative: bolton, oldham, rochdale and salford. one of jo's first jobs was to ensure that there was a network of trained primary care 'dental champions' who would lead the way in improving dental care in early years settings through supervised toothbrushing schemes. jo provided the training for champions who together brought early years settings into the programme. she also oversaw the purchasing of toothbrushes and toothpastes in bulk quantities which went into dental packs. jo said: 'interest in the programme from early years providers has been nothing less their job is critical, says ingrid, because of the high number of patients who were unable to see a dentist during lockdown: 'prevention is the way forward and we are going to see more of a need for it now. by working collaboratively with multiple stakeholders such as health visiting and school nursing teams flexible commissioning will have a positive impact on not only the dental health but also the general health of our local communities, especially in areas of severe social deprivation where you find the highest disparities in health. ' with many of the most deprived areas of the uk in the north of england, it's no surprise that targeted prevention is being driven hard. positive support for oral health prevention nationally continues to emerge and momentum is building. a key development was the green paper published last year in which the government committed to put prevention at the heart of all its health and social care decisionmaking. in terms of school toothbrushing schemes, the government said it wanted to reach % of the most deprived - -yearolds by . the green paper advocated that funding barriers to fluoridating water should be removed and local authorities which pursue water fluoridation should be rewarded by allowing them to benefit from the savings achieved via fewer fillings and extractions. water fluoridation requires no behaviour change and the evidence shows that it is highly effective in reducing dental decay and delivers the most benefit to the most deprived. dental health should now be included in the curriculum in both primary and secondary schools in england while a powerful new announcement this month from the royal college of paediatrics and child health (rcpch) reinforces the importance of all aspects of prevention of dental disease: going to the dentist, ideally starting before the age of one a healthy diet toothbrushing with a fluoride toothpaste fluoride in water working with fluoride in toothpaste to provide an extra layer of protection. another essential weapon in the prevention armamentarium is dietary advice. the mother of all prevention schemes is nhs scotland's child smile which incorporates guidance on nutrition and the frequency of sugar consumption. dental health in scotland is improving and the target of % of -year-olds having no obvious decay has been met. meanwhile, designed to smile, the programme in wales to reduce dental decay in children, is ten-yearsold and is also bringing down dental decay. in england, dentists look enviously at scotland and wales which both have national prevention programmes. this is deemed impossible in england because since , public health has been the remit of local authorities. to return to health inequalities, earlier this year and ten years on from the marmot review, the health foundation showed, shockingly, that social inequalities are now worse than they were a decade ago, especially for women. intractable problems need a creative response and one is social prescribing, an approach to health which recognises that illness can be caused by environmental or social factors. its role was also recognised in the green paper on prevention. jo ward chairs the north west social prescribing network and has led on the development of a new handbook -the national women and children's creative health handbook: wellbeing by design -which includes a section on oral health. this is yet more welcome evidence that the mouth is now being considered integral to health and wellbeing and that the methodology needs to be targeted and creative. new figures for general anaesthetics to remove teeth in children showed that there has been an % decrease in the number of - -year-olds being referred into hospital for extractions between / and / . this is welcome progress -but who knows what the impact of covid- will be? is it possible to maintain the progress that's been made? with the country still in crisis from covid- , we don't have that answer, nor do we know what will happen to the work of public health england now the government is abolishing it, or to the prevention green paper and other government commitments, but we do know that in order to be effective, prevention programmes must be funded, targeted, multi-faceted and creative. and we have an impressive groundswell of people and organisations working to give children a better start to life. fair society healthy lives (the marmot review) children's oral health improvement programme board action plan oral health as a marker for poverty putting the mouth back in the body' for greater manchester welcome to dental check by one stopping the rot: greater manchester under s to benefit for programme tackling tooth decay british society of paediatric dentistry. smiles for life! supertooth's healthy teeth guides north yorkshire & humber local dental network in practice prevention web portal advancing-our-healthprevention-in-the- s/advancing-ourhealth-prevention-in-the- s-consultationdocument area-level deprivation, childhood dental ambulatory sensitive hospitalizations and community water fluoridation: evidence from new zealand why is child oral health so important? royal college of paediatrics and child health ten years of designed to smile in wales public health in local government. the new public health role of local authorities government must take action to level up the health and wellbeing of the population. launch of the marmot review years on: health foundation response series/collection key: cord- - o g authors: jerry ii, robert h title: covid- : responsibility and accountability in a world of rationing date: - - journal: j law biosci doi: . /jlb/lsaa sha: doc_id: cord_uid: o g the covid- pandemic is the first modern public health crisis with the potential to overwhelm the public health care system. when rationing of services, drugs, and equipment must occur, health care providers have a responsibility to make rationing decisions fairly, both procedurally and substantively. in addition, health care providers, like all professionals, are accountable for their decisions. the legal standard of care requires providers to exercise the skill and knowledge normally possessed by providers in good standing in the same field or class of practice acting in the same or similar circumstances. but making rationing decisions in crisis conditions, like those created by covid- , is not the same as or similar to decision making in non-crisis conditions. thus, the standard of care, properly applied, expects less of providers practicing under the stress of covid- ’s triage conditions. because many health care providers do not perceive this is true, and for pragmatic and normative reasons, policymakers should articulate rules limiting providers’ liability for rationing decisions—as well as other acts and omissions—occurring in and attendant to crisis conditions. these rules should not, however, create absolute immunities. as the covid- pandemic unfolds, more states are embracing this approach. another kind of -invisible rationing‖ in america is rationing based on ability to pay. the indigent cannot afford to pay for care out-of-pocket (this is true for many kinds of care for broad swaths of the population), and the indigent typically do not have either the resources to purchase health insurance or jobs where employers provide health insurance. medicaid is designed to address the health care needs of the indigent, but whenever a state chooses to limit medicaid or not to expand it as invited by the aca, a kind of rationing of health care services is occurring. further, even when health care is made available to the indigent, the kind and quality of care is different. individual patients intuitively understand, for example, that a patient with symptoms of a stroke will receive treatment ahead of a patient with a sprained knee. the corollary of this understanding is an expectation that those with acute illness or serious injury will receive, i.e., will not be denied, needed treatment-as such persons are the priorities in a health care system with ample supply to serve stroke victims and those with sprained knees alike. but because american civilians lack significant experience with events or circumstances causing a need for rationing and triage, the general public lacks reference points to understand what happens when the corollary does not hold and care must be denied to some of the acutely ill. perceptions about this subject are diverse, inconsistent, and in many respects irreconcilable, as is evident in ongoing debates over medical futility, prolonging the life of terminally ill patients, and the question of who decides (i.e., the conflict between physician authority and patient autonomy). covid- has the potential to force a public reckoning with all of these difficult issues. drs. neil wenger and martin shapiro, in a recent op-ed on allocation of scarce resources and the covid- pandemic, concisely and accurately described the issue and the framework for making the difficult decisions that lay ahead. see, e.g., frank newport, americans' mixed views of healthcare and healthcare reform, gallup polling matters, may , , https://news.gallup.com/opinion/polling-matters/ /americans-mixed-views-healthcarehealthcare-reform.aspx (accessed aug. , ) (-americans have mixed views about almost all aspects of the healthcare system‖); allen guelzo, rationing care is a surrender to death, wall st. j., mar. , , https://www.wsj.com/articles/rationing-care-is-a-surrender-to-death- (visited july , ) (discussing diverse opinions in past and present discussions about health care rationing). reviewing recent literature, aghabarary and nayeri identified the many definitions of medical futility, and concluded that -[m]edical futility is an extremely complex, ambiguous, subjective, situation-specific, value-laden, and goal-dependent concept which is almost always surrounded by some degrees of uncertainty. many states have guidelines for rationing during pandemics, and all of these plans call for a committee or a triage officer who is not providing direct patient care to make the rationing decision based on neutral application of objective medical criteria. the rationales for this approach include promoting consistency of outcomes (which is vital to public trust), eliminating conflicts of resource commitments, and relieving treating physicians of the stress involved in deciding patients' fates. but when, for example, attending physicians determine that a patient needs to be placed on a ventilator, the window of time for saving the patient is narrow, and it is not difficult to imagine surge conditions where time does not allow contacting or consulting the triage committee or officer. in such extreme circumstances, these difficult judgments about resource allocation will need to be made by individual treating physicians providing care on the front line. because the medical profession's core values align in absolute support of patients, undertaking or being cast in a role in which one must decide not to care for a patient is the assumption of a profoundly unwelcome task. whether rationing decisions are made by committee, triage officer, or an individual physician in the midst of a surge-created crisis, the decisions are subject to review in accordance with the standards applicable to any other decision, act, or omission occurring in the course of the delivery of health care services. this possibility of ex poste review applies to all who hold themselves out as professionals in any field (medicine; law; engineering; etc.) and who use their expertise to provide advice or services (or both); being second-guessed by others who enjoy the benefit of hindsight comes with the territory. this reality devolves from two fundamental principles common to all professions. professionals, regardless of field, have the responsibility to serve their clients, patients, and customers in accordance with the standards of care appropriate to their profession. further, the relationship between the professional and those served is such that the professional is accountable to the person served for failing to adhere to the appropriate standard of care. in health care, this translates into a principle that a health care provider who undertakes to render professional care is required to exercise the skill and knowledge normally possessed by providers in the same field or class of practice in good standing in the same or similar circumstances. this does not mean that the provider guarantees a successful outcome, let alone perfection. it does not require a provider, in a situation where she exercises professional judgment, to pursue the same options or make the same decisions that other competent providers may make in situations where different competent providers approach problems in different ways. the standard does not require -average‖ performance from the provider-because that would lead to the absurd conclusion that half of the profession is automatically committing as the standard of care first developed, the members of the profession -in similar communities‖ were used to determine the standard. see restatement (second) of torts: undertaking in profession or trade § a ( ). this aspect of the rule was referred to as the -locality rule,‖ and it emerged before medical training and certifications were based on national standards. as applied, the locality rule placed a geographic dimension on the standard of care based on the assumption that the skills and knowledge of practitioners in, for example, rural villages would be inferior to those of practitioners at medical centers in large cities. the emergence of national practice guidelines and standardized training undercut the logic of the locality rule, and thus by the early twenty-first century, nearly all states had abandoned the locality standard and adopted a national standard of care. the -same or similar circumstances‖ requirement, however, allows for consideration of the fact that a physician in a small rural town may lack the resources, e.g., equipment and facilities, available in a larger city, and this is malpractice. rather, the standard is cast in terms of a minimum-that the physician is expected to use at least the degree of care and skill expected of a reasonably competent practitioner in the same class to which he belongs, acting in the same or similar circumstances. the -same or similar circumstances‖ element is important. no one needs to be told that performing triage in the middle of a pandemic is dissimilar to practicing medicine in the routine, normal world. caring for patients in an emergency room when beds and ventilators are scarce, personal protective equipment (ppe) is running out, the safety of providers is threatened, staff is overworked, and the influx of patients is growing exponentially are not the -same or similar circumstances‖ to those encountered in a world without covid- . thus, the law's standard of care principle does not anticipate or expect that a physician, nurse, or other provider dealing with the stress of the covid- battlefield will perform with the same level of judgment, execution, and excellence that she would have achieved if she were practicing in a normal world. when any provider is required to work in haste in a crumbling infrastructure to treat increasing numbers of casualties and to make quick decisions about rationing scarce resources, mistakes will be made -but this does not mean that the quality of services being provided falls below the standard of care. see also ama op. . . , supra n. . the iom guidance makes this point with an illustration of ventilator allocation in a pandemic. after reviewing existing disaster policies that address ventilator allocation, the letter stated: -several disaster policies reviewed by this committee require the use of evidence-based tools to assess the likelihood of benefit from critical care resources, and the reallocation of such resources under conditions of extreme scarcity to patients with the greatest likelihood of benefit when a clear and substantial difference in prognosis exists. these policies comport with an ethical framework that stewards resources and saves the greatest number of lives. . . what a disaster triage policy based on the duty to steward resources would do is effectively override individual thus, what the standard of care requires of physicians and other providers in emergencies, triage conditions, or mass disasters changes from what is required in a normal world. from the individual patient's perspective, this means that treatments that would ordinarily have been provided by reasonably competent physicians in a crisis-free health care environment might not be provided in a crisis environment where rationing is occurring. this means that the patient who feels aggrieved by a denial of care and has a valid claim in a non-crisis environment does not necessarily have a valid claim in a crisis environment. although the law's standard of care analysis, described above, is complete, cogent, and convincing as a theoretical matter, a fair assessment of the situation on the ground is that the theory does not work perfectly in practice. liability exposure is a concern for professionals in every occupation, but in the health care profession, this concern is especially acute. the reasons for this are very complex and defy brief explanation. no objective observer seriously argues that the tort liability system needs no improvements, but health care providers' commonly held perceptions about their liability risks are often unsupported by the empirical evidence about incidents, litigation results, and the factors driving insurance costs and risk. yet whatever the patient preferences and instead supply resources based on evidence-based assessments of the benefit of the treatment relative to its scarcity.‖ reality, perceptions of reality drive behavior. and it is a widely held perception in the health care profession that -[e]xisting medical standards of care are not sufficiently flexible to encourage health care professionals to act appropriately and decisively in a public health emergency.‖ significantly, the authors of that assessment, who were several members of the iom committee that drafted an important report on crisis standards of care, described that assessment as -a fact supported by federal findings, highly divergent state approaches, and practitioners' field experiences.‖ the law's standard of care, properly applied, provides great deference to health care providers' decisions about the rationing of medical care during a crisis. but if health care ) (-the medical liability system costs the nation more than $ billion annually. this is less than some imaginative estimates put forward in the health reform debate, and it represents a small fraction of total health care spending. yet in absolute dollars, the amount is not trivial‖); j. ( ) whether and to what extent volunteer health practitioners have actually been subject to liability claims. id. it -also determined that such information is unlikely to be generated in any useful and reliable form in the foreseeable future.‖ id. the commission decided, however, that liability standards should nevertheless be clarified to address the uncertainties and perceptions articulated by providers and entities, such as the american red cross, that organize responses to such emergencies. see id. the commission considered the perceptions strong enough to -create a significant risk that adequate health services needed to reduce morbidity and mortality within affected populations would not be available.‖ id. the triggering event for applying a crisis standard of care is a disaster or emergency; thus, it should follow that the crisis standard should be applied only to care directly affected or influenced by the disaster or emergency, and not to care unaffected by the circumstances giving rise to the disaster or emergency declaration. accordingly, the existence of a pandemic does not, and should not, create a blanket limited immunity for all health care professionals practicing in all fields in all circumstances. to illustrate, trauma care specialists in an emergency room challenged by an overrun of patients due to pandemic conditions should be subject to a more lenient standard than a surgeon who operates on a patient during a pandemic but under conditions that are no different from those prevailing in normal circumstances. similarly, a nursing home that provides the same services with the same staff to the same number of patients should not receive the protections of a crisis standard simply because a public health emergency has been declared. some state statutes enacted in to created limited immunities for health care providers during the covid- pandemic contain language that seeks to operationalize this distinction. for example, the massachusetts statute provides a limited immunity to health care providers from -suit and civil liability for any damages alleged to have been sustained by an act or omission‖ by the health care provider -during the period of the the rationales supporting this conclusion are both pragmatic and normative. pragmatically, if uncertain liability rules deter some health care providers from providing emergency health care services during an emergency, the public's most important interests are not served to the extent deterrence occurs. further, because the flexible common law standard of care principle becomes more lenient in crisis conditions, statutory limited-liability rules do not reduce provider accountability substantially more than the common law rules do already-and arguably less than the other benefits bestowed on the public from eliminating the deterrent effect of uncertain rules. a normative rationale is grounded in the principle of reciprocity. when society asks some of its members to take great personal risks in serving the public's interests, it is reasonable to expect society to assume some responsibilities for them in return for the risks assumed. this reciprocal norm is most obviously evident in the relationship between society and members of the military-where society owes support to those who risk their lives to protect the homeland from national security threats. in the case of health care providers working on the front lines during a pandemic, it is reasonable to expect society to make available to the providers the nursing homes push for immunity from lawsuits as covid- deaths top , , chic. trib., may , , https://www.chicagotribune.com/coronavirus/ct-nw-coronavirus-nursing-home-liability- -wlu rvu xnd bcezblpqa exaq-story.html (accessed may , ). in the absence of empirical evidence demonstrating the extent of the deterrent effect of uncertain liability rules in this context, see prefatory note, supra n. , this assertion is necessarily intuitive. the scope of the health care provider's duty to treat during a pandemic raises enormously challenging questions, all of which are put squarely on the ) (providing that no -private person, firm or corporation and employees and agents‖ thereof -who renders assistance or advice at the request of the state‖ or political subdivision -during an actual or impending disaster‖ shall be -civilly liable for causing the death of, or injury to, any person‖; applies to any -public health emergency,‖ which is defined, inter alia, as -an occurrence or imminent threat of an illness or health condition that: (a) is believed to be caused by . . . (ii) the appearance of a novel or previously controlled or eradicated infectious agent or biological toxin,‖ § / ); colo. stat. § - . - . ( ) ( )(laws , ch. , § ) (providing that -[s]uch persons and entities‖-referring to -each hospital, physician, health insurer or managed health care organization, health care provider, public health worker, or emergency medical service provider‖--that in good faith comply completely with board of health rules regarding the emergency epidemic and with executive orders regarding the disaster emergency shall be immune from civil or criminal liability for any action taken to comply with the executive order or rule‖); tenn. stat table, https://www.networkforphl.org/wpcontent/uploads/ / /legal-liability-protections-for-emergency-medical-and-public-health-responses.pdf (accessed apr. , ). hoffman, supra n. , at - . although the federal has waived large parts of its immunity under the federal tort claims act, u.s.c. § § - ( ), immunity is retained for situations involving -a failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the government.‖ u.s.c. § (a). states have similarly limited sovereign immunity while retaining liability for state officials' and employees' discretionary decisions. to illustrate, in city of daytona beach v. palmer, so. d (fla. ) , the florida supreme court held that a city who employed firefighters was immune from liability for discretionary actions and decisions made by the firefighters when combatting a fire. this is analogous to the immunity that extends to health care providers, acting under the authority of state law or as the agents of state officials, for discretionary decisions made when providing medical care during a public health disaster. unfolded. as of august , at least eleven states- new york, new jersey, kentucky, massachusetts, wisconsin, oklahoma, north carolina, kansas, iowa, utah, and on april , , new york enacted the emergency of disaster treatment protection act, n.y. pub. health § ( ), which provides that -any health care facility or health care professional shall have immunity from any liability, civil or criminal, for any harm or damages alleged to have been sustained as a result of an act or omission in the course of arranging for or providing health care services‖ if three elements are satisfied: the care or services is rendered pursuant to a covid- emergency rule, the care is arranged or provided -in response to or as a result of the covid- outbreak and in support of the state's directives,‖ and the care is arranged or provided -in good faith.‖ on april , , new jersey enacted a new statute providing that -a health care professional shall not be liable for civil damages or injury or death alleged to have been sustained as a result of an act or omission‖ when -providing medical services in support of the state's response to the outbreak of coronavirus disease‖ during the covid- declaration of emergency, so long as the act or omissions does not constitute a -crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct.‖ n.j. sess. law. ch , sen. no. ( ), https://legiscan.com/nj/text/s / (accessed aug. , ). effective march , , a kentucky statute provides: -a health care provider who in good faith renders care or treatment of a covid- patient during the state of emergency shall have a defense to civil liability for ordinary negligence for any personal injury resulting from said care or treatment, or from any act or failure to act in providing or arranging further medical treatment, if the health care provider acts as an ordinary, reasonable, and prudent health care provider would have acted under the same or similar circumstances.‖ ky. sess. laws ch. , s.b. , § (b). section (b) essentially restates the common law rules of tort for medical malpractice, but explicitly extends the defense to health care providers who prescribe medicines for off-label use, who practice outside the professional scope of their practice, or use equipment or supplies outside of the product's normal use. id. effective april , , massachusetts statutory law states that health care professionals and facilities -shall be immune from suit and civil liability for any damages alleged to have been sustained by an act or omission . . . in the course of providing health care services during the period of the covid- emergency,‖ provided that the health care is being administered pursuant to the emergency and that the care or treatment was impacted by conditions resulting from the pandemic. mass. sess. laws ch. (s.b. ), an act to provide liability protections for health care workers and facilities during the covid- pandemic, apr. , , https://malegislature.gov/laws/sessionlaws/acts/ /chapter (accessed aug. , ). effective april , , wisconsin grants immunity to health care providers -for the death of or injury to any individual or any damages caused by actions or omissions‖ that were provided during the covid- state of emergency or up to days after its termination if such acts or omissions are rendered pursuant to the -direction, guidance, recommendation, or other statement made by a federal, state, or local official to address or in response to the emergency or disaster.‖ wis. stat. § . ( ) ( - wis. legis. serv. ). effective may , , oklahoma provides immunity to health care providers from civil liability for any loss or harm to a person with a suspected or confirmed diagnosis of covid- if the act or omission -occurred in the course of arranging for or providing covid- health care services for the treatment of a person who was impacted by the decisions, activities or staffing of, or the availability or capacity of space or equipment by, the health care facility or provider in response to or as a result of the covid- public health emergency‖ and gross negligence or willful or wanton misconduct was not involved. ok. stat. tit. , § ( )(s.b. ). effective may , , a north carolina statute provides that any health care provider or facility that arranges or provides services -pursuant to a covid- emergency rule‖ -shall have immunity from any civil liability for any harm or damages alleged to have been sustained as a result of an act or omission in the course of arranging for or providing health care services only if all of the following apply‖: ) the care is provided -in response to or as a result of the covid- pandemic‖; ) the care is -impacted, directly or indirectly . . . by a [facility's or provider's] decisions or activities in response to or as a result of the covid- pandemic; and ) the care is provided in good faith. n.c. stat. § - . ( )(s.l. - , s.b. ). effective june , , kansas law provides that -a healthcare provider is immune from civil liability for damages, administrative fines or penalties for acts, omissions, healthcare decisions or the rendering of or the failure to render healthcare services, including services that are altered, delayed or withheld, as a direct response to any alaska -and the district of columbia had enacted covid- -specific limited immunities for health care providers, and it is likely that legislatures in additional states will join this group. in addition, in some states, governors have issued executive orders extending liability protections in response to covid- . one of the early such orders was issued by governor cuomo of new york, which, among other things, extended immunity to physicians and other health care providers from -civil liability for any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the state's response to the covid- outbreak‖ unless it was arkansas. at the federal level, section of the cares act, in a non-crisis environment, as long as the queue of patients is cleared and no one suffers as a result of being -demoted‖ or delayed when a concierge patient or vip jumps ahead in the queue, the preference given to the privileged patient does not, at least as reasoned under existing consensus norms, violate principles of fairness or justice. see sources cited at nn. - . also, as the right to equal access to public goods is understood and implemented in the u.s., this differential treatment is not -unequal.‖ rights to public goods are understood, at least as these values are operationalized in the u.s., as a right to a minimally defined packages of benefits, which are available to all equally without regard to income or status. after this minimum level of benefit is provided, individuals can purchase additional benefits, and the possibility of purchasing additional benefits, which is available only to those with a greater ability to pay, does not violate this understanding of equality. to illustrate, all citizens are entitled to police protection as a public good, but any individual who wishes to purchase a security system or security service on top of what the public fisc provides is entitled to do so. this is not the only definition of equality or just distribution possible, but at least as practiced in the u.s., equality does not require that all public goods be provided equally -all the way up.‖ rather, the operative understanding of equality is that only that a minimum must be provided to all (with the quantity of that minimum entitlement being defined in the political process), with differential additional benefits beyond that minimum being allocated based on ability to pay. this rationalizes why preferential access to health care by the wealthy and other privileged persons is not considered per se unfair or unequal. as noted in the text, however, this analysis does not apply under conditions of scarcity where rationing occurs. symptoms needed tests the most, the testing of fifty-eight celebrity nba professional athletes based on the fact of their exposure violated this principle. in august , some professional sports leagues and university athletic conferences are attempting to resume competition safely by frequently testing athletes and coaches; this prioritization amidst a seriously deficient testing infrastructure for the general public is controversial. therapeutics, and vaccines-should go first to front-line health care workers and others who care for ill patients and who keep critical infrastructure operating, particularly workers who face a high risk of infection and whose training makes them difficult to replace. these workers should be given priority not because they are somehow more worthy, but because of their instrumental value: they are essential to pandemic response. if physicians and nurses are incapacitated, all patients-not just those with covid- -will suffer greater mortality and years of life lost‖). colleagues, or to other influential people who have no direct role in the crisis response. the slope on which these determinations are made is slippery, but the core criteria guiding prioritization are clear. wealth and status should not be used to ration health care services during a public health care crisis. see emanuel, supra n. (-priority for critical workers must not be abused by prioritizing wealthy or famous persons or the politically powerful above first responders and medical staff-as has already happened for testing. such abuses will undermine trust in the allocation framework‖). first responders-police and firefighters-should receive preference, as they are needed to maintain public order, preserve threatened facilities, and perform rescue during a crisis. the same can be said of national guard and other members of the armed forces who are essential to disaster response and national defense. if being involved in providing -essential services‖ becomes the criterion for preferential ordering in triage, decision-making may become too complex for health care providers, with negative consequences for accuracy and fairness. the term -essential services‖ has its own difficulties, as it arguably reaches everyone involved in providing clean water, sanitation services (including garbage removal), hygiene products and services, communication support (telephone, internet, media), public utilities and energy production (gas; electricity), food production, transportation, and sale, transportation (gasoline, road maintenance and repair, common carriers and their support), banking and related financial services, tax collection, payroll departments, and every business, activity, or government regulator upon which any of these depend. see christopher c. krebs, memorandum on identification of essential critical infrastructure workers during covid- response, available at department of homeland security, cisa, https://www.cisa.gov/publication/guidance-essential-critical-infrastructure-workforce, (mar. , ) (accessed apr. , ). arguably, only a small minority of industries and businesses (tourism, barber shops and salons, entertainment) are not essential. but the problem with giving priority to individuals in all -essential businesses‖ is that some states have included within the classification some businesses that clearly are not essential. see, e.g., samantha j. gross, is pro wrestling an ‗essential business' in florida? gov. ron desantis says it is, tampa bay times, apr. , , https://www.tampabay.com/florida-politics/buzz/ / / /is-pro-wrestling-an-essentialbusiness-in-florida-gov-ron-desantis-says-it-is/ (accessed apr. , ); many commentators have sought to identify the values guiding rationing decisions in a pandemic. an excellent articulation synthesizing prior conceptualizations of allocation frameworks can be found in emanuel et al., supra n. (stating six recommendations; ) maximizing benefits is most important; ) interventions (testing, ppe, etc.) should go first to front-line health workers and those supporting them; ) patients with similar prognoses should be treated equally and operationalized through random allocation; ) priorities should change in response to changing scientific evidence; ) those participating in research on vaccines and therapeutics should receive some prioritization; ) no differences should exist between allocations for covid- patients and those with other medical conditions, i.e., all patients needing resources should be considered for allocations equally). see repine et al., supra n. (-the role of physician doing triage is conceptually very clear but is practically and ethically very complicated‖); emanuel et al, supra n. (-[e]ven well-designed [prioritization] guidelines can present challenging problems in real-time decision making and implementation. to help clinicians navigate these challenges, institutions may employ triage officers, physicians in roles outside direct patient care, or committees of experienced physicians and ethicists, to help apply guidelines, to assist with rationing decisions, or to make and implement choices outright-relieving the individual front-line clinicians of that burden. institutions may also include appeals processes, but appeals should be limited to concerns about procedural mistakes, given time and resource constraints‖). the same questions will arise with respect to prioritizing access to a covid- vaccine once it becomes available. the same standards should apply, with the possible addition that those who volunteered for vaccine clinical trials should get some priority under the norm of reciprocity. see jon cohen, the line is forming for a covid- vaccine. who should be at the front?, science, june , , https://www.statnews.com/ / / /when-a-covid- -vaccine-becomes-available-who-should-get-it-first/ (accessed aug. , ); sandeep jauhar, when a covid- vaccine becomes available, who should get it first?, in the final analysis, in a public health emergency like the covid- pandemic where demand for health care surges past available supply, health care providers must make life-ordeath decisions about the rationing of health care services. this is their responsibility-not one they desire to own, but one they unavoidably inherit. when fulfilling this responsibility, they bear accountability for their decisions under existing standards of care, including the common law rules of tort and an array of federal and state statutes. these standards appropriately give health care providers much latitude when implementing triage and rationing decisions in good faith under emergency conditions. but accountability must never disappear, for without that, the public's trust in the profession would be lost. in time of crisis, trust is something none of us can afford to ration. stat, may , , https://www.statnews.com/ / / /when-a-covid- -vaccine-becomes-available-whoshould-get-it-first/ (accessed aug. , ). the choice of criteria in these plans, including whether they promote fairness and equity, presents difficult and controversial questions the toughest triage-allocating ventilators in a pandemic, n. eng (discussing how -limited time and information‖ available to those deciding priorities for allocation of scare resources during the covid- pandemic justifies simplification of the rationing analysis, as -incorporating patients' future quality of life, and quality-adjusted life-years into [the] benefit maximization malpractice liability and the rationing of care, tex. l. rev. , ( ) (-for the profession itself to recognize an ethical duty to ration care would fundamentally challenge the very meaning of professionalism-the physician's unequivocal if it comes to rationing, i shouldn't have to be the one deciding who should live and who should die rationing medical resources: a constitutional, legal, and policy analysis, tex see also donna levin ) (writing in the context of covid- , authors state that -hcws who take significant risks to provide care to other are leery of subsequent lawsuits responders' responsibility: liability and immunity in public health emergencies soc'y to governor jared polis, -liability protection expansions for health care professionals on the front lines of the coronavirus pandemic state of disaster emergency declared [under state law]related to the covid- public health emergency an iowa state states that -[a] health care provider shall not be liable for civil damages for causing or contributing, directly or indirectly, to the death or injury of an individual as a result of the health care provider's acts or omissions while providing or arranging health care utah statutory law states that -[a] health care provider is immune from civil liability for any harm resulting from any act or omission in the course of providing health care during a declared major public health emergency‖ for treatment of conditions that resulted in the declaration alaska excludes liability for any health care provider -who takes action based on a standing order issued by the [alaska] chief medical officer . . . for civil damages resulting from an act or omission in implementing the standing order district of columbia exempts any -healthcare provider, first responder, or volunteer who renders care or treatment to a potential, suspected, or diagnosed individual with covid- . . . from liability in a civil action‖ for damages or resulting from any act or failure to act in providing or arranging treatment. d.c. code § (in -proposed legislation (bills), adv: -immune! liabil! /p -health emergency‖ coronavirus covid- /p physician provider). some states have enacted statutes that create immunities for transmission of covid- on business premises (as might occur when a customer is on the premises) and sometimes on personal premises. these statutes have general applicability could be relevant to a claim arising out of an infection allegedly received in a health care establishment stating that a person or agent -who conducts business in this state shall not be liable in a civil action claiming an injury from exposure or potential exposure to covid- ‖) during period of covid- emergency declaration, essential businesses and emergency response entities -have immunity from civil liability . . . with respect to claims from any customer or employee‖ for injuries or death allegedly caused by -the customer or employee contracting covid- while doing business with or while employed by the essential business‖). caused by the provider's -gross negligence.‖ similar executive orders have been issued by governors in illinois continuing temporary suspension and modification of laws relating to the disaster emergency executive order in response to covid- protection of public health and safety during covid- pandemic and response-protections from civil liability for healthcare providers and billing protections for patients ) (declaring that health care facilities with -emergency operation plans‖ that have -alternative standards of care‖ may implement those alternative standards order of the governor of the commonwealth of pennsylvania to enhance protections for health care professionals the -good samaritan‖ order: protecting frontline healthcare workers responding to the covid- outbreak declared all health care providers and facilities, first responders, and others -auxiliary emergency management workers,‖ which had the effect of bestowing civil liability immunities on them by virtue of ga ) (declaring that during the pendency of the covid- emergency proclamations, health care facilities, professionals, and volunteers are immune from civil liability for death or injury or property damage that -occurred at a time when the order - , increasing hospital and nursing facility capacity, extending statutory immunity ) and affirming its applicability during the covid- crisis to -health care workers providing community-based health care, services at surge hospitals and services in existing hospitals, nursing facilities and alternative nursing care sites‖) ) (extending immunities to health care providers and facilities responding to covid- , as first ordered in exec ( ), a longstanding statute declaring emergency management activities to be governmental functions with immunities and protections, to health care providers responding to the covid- pandemic. dec. of emer. dir. (nevada) ) (extending immunity to health care facilities and personnel for covid- health emergency response efforts) certain-immunity-from-liability-for-healthcare-providers-in-response-to-novel-coronavirus-(covid- ).pdf (accessed aug. , ), reinforces statutory immunities for health care providers when responding to public governor whitmer issued and then extended an executive order granting immunity to any licensed health care professional or health care facility providing services in support of the state's response to the pandemic, but then rescinded the order on requested -health care providers‖ generally to respond to the covid- pandemic, and declared that all such providers would have immunity from civil liability under ark the immunity does not apply if the care is -willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the individual harmed,‖ or the health care professional was -under the influence [as determined by state law] of alcohol or an intoxicating drug triage of mass casualties in war conditions: realities and lessons learned covid- pandemic: triage for intensive-care treatment under resource scarcity articulating allocation standards that are recognized as -fair‖ and -equitable‖ by all affected parties is an elusive undertaking celebrities get virus tests, raising concerns of inequity preferential coronavirus testing of nba athletes, celebs ‗ % wrong is it a problem that sports gets fast test results and you don't? but is it ethical? is it a problem that sports gets fast test results and you don't? as sports return, experts fear leagues will use up scarce covid- testing resources who should be saved first? experts offer ethical guidance rigal and pons discussion of triage pertained to soldier and civilian casualties during -wartime conditions.‖ although their discussion rejects ability to pay (i.e., concierge medicine) as a criterion for preference in triage, it is not clear that their discussion reaches all questions of status-i.e., whether generals or political leaders responsible for supervising the war effort, individuals in the supply chain for supporting the war effort jerry laforgia, former health specialist for the world bank) key: cord- -bsmqqi j authors: bajraktari, saranda; sandlund, marlene; zingmark, magnus title: health-promoting and preventive interventions for community-dwelling older people published from inception to : a scoping review to guide decision making in a swedish municipality context date: - - journal: arch public health doi: . /s - - - sha: doc_id: cord_uid: bsmqqi j background: despite the promising evidence of health-promoting and preventive interventions for maintaining health among older people, not all interventions can be implemented due to limited resources. due to the variation of content in the interventions and the breadth of outcomes used to evaluate effects in such interventions, comparisons are difficult and the choice of which interventions to implement is challenging. therefore, more information, beyond effects, is needed to guide decision-makers. the aim of this review was to investigate, to what degree factors important for decision-making have been reported in the existing health-promoting and preventive interventions literature for community-dwelling older people in the nordic countries. methods: this review was guided by the prisma-scr checklist (preferred reporting items for systematic reviews and meta-analysis extension for scoping reviews), the methodological steps for scoping reviews described in the arksey and o′malley’s framework, and the medical research council’s (mrc) guidance on complex interventions. eligible studies for inclusion were randomised controlled trials (rcts) concerning health promotion or primary prevention for community-dwelling older people implemented in the nordic countries. additionally, all included rcts were searched for related papers that were reporting on additional factors. eligible studies were searched in seven databases: pubmed, scopus, cinahl, academic search elite, psycinfo, socindex, and sportdiscus. results: eighty-two studies met the inclusion criteria (twenty-seven unique studies and fifty-five related studies). twelve studies focused on fall prevention, eleven had a health-promoting approach, and four studies focused on preventing disability. all interventions, besides one, reported positive effects on at least one health outcome. three studies reported data on cost-effectiveness, three on experiences of participants and two conducted feasibility studies. only one intervention, reported information on all seven factors. conclusions: all identified studies on health-promoting and preventive interventions for older people evaluated in the nordic countries report positive effects although the magnitude of effects and number of follow-ups differed substantially. overall, there was a general lack of studies on feasibility, cost-effectiveness, and experiences of participants, thus, limiting the basis for decision making. considering all reported factors, promising candidates to be recommended for implementation in a nordic municipality context are ‘senior meetings’, ‘preventive home visits’ and ‘exercise interventions’ on its own or combined with other components. the population across the world is growing older which calls for effective health-promoting and preventive interventions in order to help older people maintain a good quality of life. in accordance with the world health organisation (who), health promotion is defined as the process of enabling the population/individual to increase control over and improve their health, while disease prevention is defined as measures taken to prevent the occurrence of disease or limit its development [ , ] . the implementation of health promotion and prevention is imperative given that increased levels of dependency in managing activities of daily living (adls) is related to a reduction in self-rated health [ ] as well as higher societal costs [ ] . in sweden, municipalities have a responsibility to address health concerns and social care needs among older people ultimately aiming to optimize the person's quality of life by promoting independence and opportunities to participate in society [ ] . therefore, municipalities need to consider health promoting and preventive interventions besides, and to complement, the provision of social care. such interventions can promote various aspects of the health and well-being of older people by strengthening the person's opportunities to be active and participate in society [ ] . simultaneously, a more health promoting approach to the provision of municipality services for older people could reduce the expected increase in health and social care costs. several studies show that health promotion and prevention in different forms have resulted in a range of positive effects such as maintenance of ability to perform adls [ ] , enhanced quality of life [ , ] , prevention of functional decline [ , ] , and reduced falls [ ] . in addition, some interventions have shown to be cost-effective [ , ] . in all, examples in the previous literature indicates that positive effects can be achieved from both multi-professional and single-professional interventions [ , ] , from both short and long-term interventions [ , ] and both group-based and individual interventions [ , ] . even though the existing evidence is promising in improving health outcomes among older people, the range of interventions have varied considerably regarding their content, design and outcomes used, making them hard to compare [ ] . since resources (e.g. staff) are limited, not all promising health-promoting or preventive interventions can be implemented. thus, more information than mere evidence on effects, based on single trials, is needed to provide sufficient guidance for decision-makers on what type of intervention to implement [ ] . the question of which interventions to implement needs to be guided by a systematic decision-making process based on the best available evidence [ ] . in this systematic process, a range of factors need to be considered, e.g. intervention design, effects, cost-effectiveness, feasibility of recruitment and intervention procedures as well as an understanding of how participants experience the intervention. the challenge with this task is that many health-promoting interventions often miss to report all such information relevant for decision making [ , ] . in addition, the issue of context should be considered when assessing how evidence can be transferred from controlled trials to clinical settings [ ] . in this study, the context is focused on the nordic countries, because these countries, to a large extent, share similar welfare systems characterized by publicly funded health and social care. a scoping review design has been proposed as an effective tool to disseminate research findings and provide an overview of evidence for decision-makers and policymakers [ ] , and is especially appropriate when exploring a heterogeneous or complex body of literature [ ] . given the potentially positive effects on older peoplesh ealth and the cost-effective use of societal resources, a comprehensive overview of the existing evidence on health promoting and preventive interventions is needed. therefore, the aim of this review was to investigate to what degree factors important for decision-making have been reported in the existing health-promoting and preventive interventions literature for community-dwelling older people in the nordic countries. this scoping review follows the prisma-scr checklist (preferred reporting items for systematic reviews and meta-analysis extension for scoping reviews) [ ] as well as the methodological steps for scoping reviews described in the arksey and o′malley's framework [ ] . the arksey and o′malley's framework consists of five stages: ) identifying the research question; ) identifying relevant studies; ) selecting studies; ) charting the data; ) collating, summarizing and reporting the results [ ] . this scoping review has been conducted following an unpublished work plan. health promotion and prevention often include several interacting components and can, therefore, be considered as complex interventions. the medical research council's (mrc) guidance for the process of developing, evaluating and implementing complex interventions was used to identify the research questions of this scoping review [ ] . according to the mrc guidelines, this process includes several phases in which evaluations of feasibility, effectiveness and cost-effectiveness provide essential knowledge. in addition, the pico framework (population, intervention, comparison, outcome) which is recommended to frame the research question but also to guide the whole process in a review, was used as an additional source in guiding the formulation of the research questions regarding the population, intervention/control and effects on possible outcomes [ ] . hence, the research questions were: . in which contexts have interventions been conducted? . for which populations have interventions been conducted? . how have the interventions been designed (e.g., which components, duration of interventions and mode of delivery)? . which feasibility aspects have been described? . how have the participants experienced the interventions? . were interventions effective, and on which outcomes? . were interventions cost-effective? the eligibility criteria were defined in advance but were modified with increased familiarity with the literature. eligible studies were: ) interventions categorised as health promotion (hp) or primary prevention (pp) following the who's definition [ , ] and addressing behavioural risk factors, injury prevention, physical health, social and mental health, ) including populations of community-living older people + as of it being the lowest retirement age in the nordic countries, hence exclude the risk of missing relevant studies due to the age limitation, ) implemented in a nordic country (denmark, finland, iceland, norway, sweden and faroe islands), ) studies applying a randomized controlled trial design (rct) for the evaluation of effects (research question six), ) studies related to the identified rcts addressing the remaining research question, e.g. experiences of participants, feasibility as well as studies on cost-effectiveness. only studies written in english were included and to decrease the risk of missing relevant articles, no year limit was applied. the exclusion criteria were: secondary prevention programmes related to a specific disease or diagnosis e.g. interventions implemented for participants with a neurological condition such as stroke or alzheimer's disease, tertiary prevention programmes (e.g. rehabilitation, hospital discharge) as well as studies in populations with extensive needs for support in adls. furthermore, interventions focusing on dental health promotion; interventions targeting older people with cognitive malfunction; programmes assessing effects of medication or evaluations of effects only focused on specific body structures [ ] , were also excluded. seven online databases were searched: pubmed, sco-pus, cinahl, academic search elite, psycinfo, socindex, and sportdiscus. in designing the most suitable search strategy, a librarian at umeå university was consulted on several occasions. the search strategy was based on a combination of words to capture key terms related to the purpose of this study: "health promotion", "prevention", "old people", "community-dwelling", "nordic countries", "randomised controlled trial" and their synonyms/alternative words. a detailed outline of the search strategy, including the full syntaxes to screen the databases and numbers of search results, is available in additional file . the initial search strategy was piloted and refined in the light of early findings. the search for literature was conducted from inception to january , (last date searched). identification of studies, relevant to this review, was done in two stages. at the first stage, we identified rcts in the field of health promoting and preventive interventions for community dwelling older people conducted in the nordic countries. to decrease the risk of missing relevant studies during the first stage of identifying studies, we did not limit our search to only primary prevention programmes. we applied this inclusion criterion when screening titles and abstracts for study selection. in the second stage, reference lists of identified and selected studies from the first stage (the rcts) were examined for the purpose of identifying related studies, i.e. studies evaluating the same intervention but at different follow-ups, looking at different outcomes, or addressing the other research questions. search results were exported in endnote reference manager, which was used to remove duplicates. in the next step, the endnote reference manager was used to ease the process of identifying and excluding irrelevant studies through searching for key exclusion terms (hospital discharge, cognitive malfunction, dementia etc.). titles and abstracts of the remaining studies were organised in an excel document and read independently by all authors. studies that all authors agreed did not meet all of the eligibility criteria were removed. in cases of uncertainty, disagreement was resolved by reading the whole study and discussion among the three authors. after screening titles and abstracts and excluding studies not meeting the inclusion criteria, the remaining studies were read in full text. in line with the process of identifying research questions, the mrc framework and the pico framework were used to guide the process of data extraction. the included studies were distributed between authors sb and mz who independently charted the data for summarizing information related to the research questions, each question targeting one of the seven factors: context, population, intervention content, feasibility, experiences of participants, effects and cost-effectiveness. disagreement was resolved through discussion between all authors. all authors read the extracted data and discussed the results. main results are presented in the text under a specific heading for each of the research questions. results are presented and described by referring to either the original study/ study (at first-hand study protocol, if available. if no study protocol was identified we referred to the first published rct), related studies (other publications related to the original study) or intervention (referring to the specific interventions evaluated in each study). in the section below there is a description of the factors (data items) extracted to address the research questions. to the extent available, data on context, population, intervention content, feasibility, experiences of participants, effects and cost-effectiveness have been extracted from the included studies. the extraction of data regarding intervention context focused on identifying the setting (e.g. primary care, clinical, home, physical activities facilities) in which the specific intervention was evaluated as well as the country, and if available, the municipality in which the study was conducted. data extracted on population concerned how the target population was defined in age, frailty/morbidities, gender, and socio-economic status. the data extracted concerning feasibility was specifically focused on identifying participation rates and retention. if a pilot or feasibility study was published, the aim and main results of the study were also extracted. information on experiences of participants was extracted from related qualitative studies, and main results on experiences of participants were summarised. effects were examined by extracting effects on specific health outcomes at different time-points as reported in each study. in general, the data extracted regarding effects included effect sizes if reported, confidence intervals and p-values for outcomes for which a statistically significant difference was reported. no effect sizes, confidence intervals or p-values were extracted for outcomes upon which no significant difference was reported, they are mentioned in text however. the first step in exploring cost-effectiveness was to identify if such studies had been conducted. the primary objective when looking at identified studies on costeffectiveness was to examine if evaluated interventions were found to be cost-effective and in relation to which outcomes cost-effectiveness was established. furthermore, if available, data concerning methodological aspects of such studies were extracted, e.g. perspective used (health provider/payer or social perspective), outcome-and cost measures and how they were affected by the specific intervention, comparator (e.g. no intervention, alternative intervention) and time horizon (over which time horizon costs and effects were measured) [ ] . the search yielded a total of studies. after removing duplicates, titles and abstracts were screened and studies obviously not meeting the inclusion criteria were excluded. all remaining studies were read in full text (n = ) and studies which did not meet the eligibility criteria were removed (n = ). all original studies, identified in stage , were in stage reference checked resulting in related studies being identified and included. in all, a total of studies were included for analysis, original studies and related studies. the search process is presented in a prisma flowchart in fig. . the total number of participants in the included studies (extracted primarily from the original studies, if available) was , . one municipality-based study included a very large sample (n = , ) [ ] . considering all studies except the one by poulstrup and jeune [ ] , sample sizes varied from participants [ ] to participants [ ] . the duration of interventions varied from a one-session discussion group [ ] to three weekly group exercise sessions over a period of one year [ ] . of the original studies, focused specifically on fall prevention (looking primarily at fall-related parameters and fall risk factors, e.g. falls, fear of falling, balance performance, bone mineral density) [ , - , - , ] . eight fall prevention interventions were single component and included only exercise [ , - , , ] , while five combined an exercise component with one or more different components, e.g. preventive home visits (phv), discussion groups, nutrition, medication review [ , , , , ] . eleven studies had a health promoting approach. five of these studies focused on promoting general health (interventions which in addition to focusing on functional status also focused on health-related quality of life and/or social support aspects) [ , , , , ] , four promoted exercising [ ] [ ] [ ] ] , and two focused on promoting mental wellbeing [ , ] . the four remaining studies focused on preventing disability [ , [ ] [ ] [ ] . findings on intervention type, intervention aim, context, and population are presented below in table . these findings are also described in the text, separately for each factor, in the sections below. there were no related studies identified for of the original studies, so all related studies found were linked to only of the original studies. of the original studies: one study reported results in nine related studies [ ] , two reported in seven related studies [ , ] , and one reported in six related studies [ ] . the remaining interventions reported results in one to five related studies. for further details, see table below. among the related studies, included evaluations of effects, eight were qualitative studies analysing experiences of participants, four were health economic evaluations, three were study protocols, and two were pilot studies. findings on intervention content, effects and feasibility aspects are also described separately in the sections below, while detailed information on these factors is presented in table . geographically, the studies were conducted in finland (n = ), sweden (n = ), denmark (n = ) and norway (n = ). no studies were identified from iceland or faroe islands. interventions were implemented either at home (n = ) or in other settings (n = ), e.g. gyms and exercise halls [ , , , ] , clinics/hospitals [ , , , , ] or research centres [ , ] . the remaining interventions were implemented in a combination of settings (n = ). for further details, see table , "context" column. the population targeted in the included studies varied regarding age and health-related conditions. in six studies, the target population was defined in relation to age and location of residence [ , ] , four of these studies were municipality-based and targeted a broad population of older people from several municipalities [ , , , ] . the remaining studies defined the target population in relation to age and location of residence/municipality in [ ] , whereas two applied a narrow age span - [ ] , - [ ] . one study reported only the mean age of the participants [ ] . five studies had samples consisting only of female participants [ , table detailed results concerning intervention content, effects on health outcomes, and feasibility aspects of included studies in the field of health-promoting and preventive interventions for community dwelling older people in the nordic countries from inception to (continued) original study intervention content effects (significant between-group differences) feasibility aspects month after the intervention period. control: counselling session on fall prevention at baseline irr = . *, % ci = . - . [ ] . no sig. difference in hand grip strength, knee flexion (right/left) [ ] , incidence of falls overall [ ] or in the incidence of falls requiring medical treatment [ ] , depressive symptoms [ ] , dynamic balance [ ] . -year and -year: no sig. difference between i vs control in the incidence of falls requiring medical treatment [ ] .. walking duration increased* for combined (t and t + n) vs n and c [ ] . no sig. differences in balance, mobility, nutritional measures (e.g. body weight, energy intake) [ , ] , aerobic capacity (maximal work-load or work time) [ ] . -month: only effects in physical activity level preserved in t vs c and n [ ] . no effects were preserved on: rmr, leg press, dips, step test, muscle strength [ ] , aerobic capacity (maximal work-load or work time) [ ] , adl [ ] . , , , ] . for further details, see table , "population" column. given the broad range of intervention types, interventions varied by content, modes of delivery, duration and professionals involved. in most of the studies, the intervention content included a physical activity component (n = ). in twelve of these studies, exercise was the only component and included different exercise forms such as resistance/ strength [ ] , balance [ ] , rocking-chair training [ ] , nintendo wii exercise [ ] , or a combination of different exercise forms [ , - , , , , ] . the remaining seven studies included different components, e.g. exercise and multidisciplinary check-ups [ ] , exercise and comprehensive information on, e.g. medication, nutrition, removing home hazards [ , , ] , exercise and a social activity programme [ ] , exercise and nutrition [ ] , and exercise and vitamin d [ ] . the eight remaining studies did not include any practical exercise component. these studies included, senior meetings or discussion groups and home visits [ , , ] , a discussion group, activity groups and an individual intervention [ ] , case-management [ ] , anonymous self-care telephone calls [ ] , physical activity counselling [ ] , or an education programme for home-visitors [ ] . regarding modes of delivery, six studies were individually based [ , , , , , ] , seven were group-based [ , , , , , , ] , and studies included group and individual interventions [ , , , , , , - , - , ] . studies including only individually based interventions were provided at home and were either self-managed [ ] , supervised [ , , ] , telephone-based [ ] or digital [ ] . studies including only group-based interventions were delivered in the format of exercise groups [ , , , , , ] or an educational group [ ] . studies including both group formats and individual interventions included group formats and home visits [ , , , , , ] , group formats and home training [ , , , , ] group formats and individual counselling on health [ , , , , ] . the number of sessions included in the interventions varied, as did the duration. for individually-based interventions, the number and duration of sessions ranged from one single home visit [ , ] or one personal counselling session on nutrition [ ] to daily independently performed exercise sessions ( - repetitions) over a period of months [ ] . group-based components ranged from one single discussion group [ ] to three min exercise session a week for over one year [ ] , while the education programme for home visitors included regular education over a period of three years [ ] . studies combining group and individually-based components ranged from one single home visit and four discussion groups [ , ] to two weekly exercise sessions over one year in combination with monthly lectures on various themes and psychosocial activities combined with a single individual geriatric assessment and counselling on fall prevention [ ] . in studies, the interventions were delivered by a multiprofessional team [ - , , , , , - , , - ] including, e.g. physiotherapist, occupational therapists, nurses, dietitian, dentist and healthcare students. in twelve studies, the interventions were implemented by one profession, of which seven interventions were delivered by physiotherapists [ , , , , , , ] , one by occupational therapists [ ] , three by exercise instructors/leaders [ , , ] , and one by unspecified trained personnel [ ] . feasibility aspects were reported sporadically across studies. all interventions reported on methodological aspects table detailed results concerning intervention content, effects on health outcomes, and feasibility aspects of included studies in the field of health-promoting and preventive interventions for community dwelling older people in the nordic countries from inception to (continued) original study intervention content effects (significant between-group differences) duration: regular education ( municipal meetings) for home visitors during years and one education programme ( h) for gps in the first year control: no intervention (education program) for home visitors in another control municipalities. increased risk for catastrophic functional decline rr . ***, % ci . - . [ ] . fewer persons ( -year-olds) in the intervention group had moved to a nursing home hr . *, % ci . - . [ ] . effects on functional ability in women were preserved or . *, % ci . - . . no sig. difference in functional ability for men [ ] . no sig. difference in functional decline or mortality in both man and women [ ] . notes: *p ≤ . , **p ≤ . , ***p ≤ . . a maximum score for fes- = , higher score implies higher concern for falling, lower score implies lower concern for falling, b maximum score for bbs = , higher score implies higher degree of functional balance and vice versa, c maximum score for -item of feasibility such as recruitment and retention/dropout numbers. with recruitment numbers, we refer to the total number of eligible participants (meeting inclusion criteria) who agreed to participate in the study. the mean recruitment rate (eligible participating population/total eligible population) in all the studies included in this review was %, varying from % [ ] to % [ , , , , ] . however, there was some inconsistency regarding how the eligible population was defined. for instance, in one study the total eligible population consisted of only those who volunteered [ ] , or of the population receiving an invitation [ ] or the whole population in a specific community [ ] . thus, participation rates are not consistent among included interventions and this inconsistency should be taken into consideration when interpreting the mean recruitment rate. mean retention rate in the total number of original studies included in this literature search was %. retention rate varied from % [ ] to % [ ] . beside the information related to recruitment and retention rates, only two feasibility/pilot studies were identified [ , ] . kristensson et al., investigated the feasibility of a case management intervention by specifically assessing sampling and sample characteristics as well as possible effects on perceived health [ ] . lood et al., ( ) investigated the feasibility of evaluating senior meetings in the "elderly in the risk zone" intervention [ ] among a specific group of older people (foreign-born) by specifically assessing recruitment and retention rates, questionnaire administration, and variability of data [ ] . in relation to five of the original studies, eight related studies explored the experiences of participants [ , , , ] or both the experiences of participants and professionals delivering the intervention [ , , , ] . based on qualitative methods and interviews, participants' experiences were described related to i) a single preventive home visit (phv) [ ] , ii) senior meetings [ , , , ] , iii) multidisciplinary fall prevention programmes [ , ] , and iv) case management intervention [ ] . findings from interviews on phvs showed that home visits contributed to empowerment and increased selfesteem by making participants feel in control over their health. however, for some, it did not come at the right time, either because they felt too healthy to benefit from it or because they felt too ill to be able to participate [ ] . findings on senior meetings revealed that although independent older people may find it difficult to accept or act upon health-promoting information, the discussion groups, provided in a multi-dimensional approach, could motivate acting upon such information, and thus, senior meetings were perceived as a "key to action" [ ] . these findings were in line with experiences of foreign-born older people who felt empowered by the opportunities gained, such as the possibility to meet other people, discuss experiences, as well as become acquainted with possibilities to make everyday life better and safer [ ] . however, their capabilities to adhere and act upon knowledge in the long-term (six months to one year after their participation in the programme) was dependent on personal and environmental resources [ ] . furthermore, professionals delivering the interventions, revealed that for a senior meeting intervention to succeed in reaching out to the target group, it is necessary to recognise the person's resources and empower their capabilities in maintaining health [ ] . empowerment and raised awareness were also emphasized in a group-based multidisciplinary fall prevention program delivered through a client-centered approach. the involved professionals observed that building trust and a safe atmosphere within the group increased participants' engagement in discussions which contributed to the success of the intervention. a contributing factor for creating this sort of atmosphere was the role-shifting negotiated by the group leaders from being the expert to being a facilitator of the discussion [ , ] . however, it was noticed that for a group format to be successful, group composition should be taken into consideration for the participants to feel fellowship [ , ] . furthermore, in a home-based case-management intervention, participants experienced case managers as a helping hand in navigating within the health system, and thus, contributed to feelings of control and safety [ ] . additionally, experiences of participants were explored as secondary outcomes through a survey related to a nintendo wii training fall prevention intervention [ ] , or through a single open-ended question related to a telephone-based health-promoting intervention [ ] . findings from the survey showed that training with a digital device (wii) was experienced positively and did not lead to any adverse effect [ ] . a self-care telephone intervention influenced participant's attitudes positively, e.g. towards self-care [ ] . for several interventions, effects were evaluated in relation to a wide range of outcomes, and all, besides one intervention on nutritional counselling [ ] , reported a positive effect on at least one health outcome evaluated in comparison to a control group. however, the magnitude of effects and follow-ups at which interventions were evaluated, varied substantially and therefore, should be taken into consideration when evaluating effects. to summarise intervention effects, we classified health outcomes in broader categories (table ) . for example, balance confidence, balance performance, dynamic balance, impaired balance, postural balance, postural sway, velocity moment in standing balance, are categorised under "balance". details on effects are found in table . four studies presented a health-economic evaluation. three studies adopted a cost-effectiveness analysis method [ , , ] and one a cost-utility analysis method [ ] . two studies provided an economic evaluation of single interventions; a case-management intervention [ ] and an education programme for home visitors [ ] . the other two studies compared different interventions focused on health promotion [ ] , and falls prevention [ ] . in these four studies, a societal perspective was chosen including cost from different sectors e.g., health care and social care. the time horizon used varied from three months [ ] , one year [ , ] , two years [ ] and up to three years [ ] . all studies based their estimates of costs on intervention costs, healthcare costs and municipality costs. in addition, the value of informal care was included in one study [ ] . costeffectiveness was evaluated in relation to active life-years gained [ ] , quality-adjusted life-years (qalys) [ , ] and number of injurious falls prevented [ ] . findings from the economic analysis showed that two interventions were considered cost effective [ , ] whilst two were not [ , ] . a one-session discussion group was found to be more cost-effective when compared to an individual intervention or an activity group in an intervention comparing three different occupation-focused healthpromoting interventions to a control group [ ] . the discussion group showed significant effects on qalys gained at and month follow up's and lower total costs [ ] . furthermore, an exercise intervention showed high probability to be cost-effective in preventing falls in relation to a threshold of euro per injurious fall prevented when compared to three other fall preventive interventions focusing on exercise and vitamin d supplements [ ] . in contrast, no significant difference was observed in total costs or qalys gained when comparing a case management intervention to no intervention in a cost-utility analysis. nevertheless, the case management intervention led to lower levels of informal care and need for help with instrumental adls [ ] . neither did a training programme for home visitors result in significant differences in total cost or active life-years gained in comparison with usual practice of performing preventive home visits [ ] . this scoping review provides a comprehensive overview of health-promoting and preventive interventions for community-dwelling older people in the nordic countries that to some extent, can guide decision-making in a swedish municipality context. however, while all included studies report some positive effects, not all potentially effective interventions can be implemented since resources are limited. thus, the evidence on effects needs to be critically reflected upon, but several other factors need to be considered as well. our study exposes gaps in knowledge regarding cost-effectiveness, experiences of participants and feasibility of the interventions, knowledge that could broaden the understanding of which interventions seem most promising and feasible to implement from a decision-makers´perspective. while the scope of this review includes interventions with different foci, the summary of findings on the seven evaluated factors, show that some interventions such as senior meetings, preventive home visits (phv) and exercise interventions alone or combined with other components, seem to be strong candidates for implementation, e.g. [ , , ] . in all, the total evidence for these interventions included positive effects on a range of outcomes, in some cases confirmed by evaluations at different follow-ups, with established cost-effectiveness, and supported by qualitative findings based on the experiences of participants. in the section below we provide a deeper discussion about the previously mentioned intervention examples and argument how the findings from this review could guide decision making and how additional knowledge, generally missing across the different interventions, is needed to better guide decisions on which interventions to implement. senior meetings, one type of intervention investigated in four different studies, seems potentially effective in promoting general health and wellbeing among communitydwelling older people [ , , , ] . the study which provides the broadest evidence base is the "elderly persons in the risk zone"-study conducted in gothenburg [ ] , which evaluated a four-sessions senior meeting intervention combined with a home visit. several related studies support the implementation of senior meetings given the positive results on a range of health outcomes, e.g., physical function [ ] and adls [ ] , outcomes for which effects were established at different follow-ups ( months to -year follow-ups). qualitative findings on the experiences of participants also provide an understanding of why the intervention was effective by concluding that senior meetings were experienced as a "key to action" in empowering participants to engage in preventive approaches to improve health [ ] . the benefits of senior meetings, albeit with other content, were also verified in the studies by zingmark et al., [ ] and johansson et al., [ ] . in the study by zingmark et al., [ ] two group-based formats of interventions (a discussion group and an activity group) were implemented by occupational therapists which both resulted in positive effects. in our results, evidence on costeffectiveness regarding senior meetings was limited to the study by zingmark et al., who found a one-session discussion group to be the most cost-effective intervention format [ ] . recently, however, a publication based on data from the "elderly persons in the risk zone" supports the cost-effectiveness of senior meetings as well, even in the long term (over four years) [ ] . thus, senior meetings seem to be a strong candidate for implementation in a swedish municipality context. yet, the exact format can be further discussed given the variation in the number of sessions and the specific content, e.g. one session discussion [ ] , four sessions combined with a home visit [ ] , twelve sessions combined with two home visits [ ] . in addition, feasibility aspects related to recruitment during implementation in a municipality context seem to be a critical feature to improve reach in the intended population, thus requiring specific contextual knowledge [ ] . our results show that phvs have the potential to improve general health by preventing deterioration in health in community dwelling older people. however, phvs have varied regarding the specific format e.g. from one visit [ ] to twelve visits [ ] and have shown positive effects on several outcomes e.g. limiting progression in morbidity [ ] , reducing the number of emergency department visits [ ] , maintaining adl ability [ ] reducing lower extremity fractures [ ] . positive effects were also reported for an education programme for the home visitors conducting the phvs, in terms of lower admission rates to nursing homes for those receiving two home visits per year [ ] . the most promising results on phvs were established in the "elderly persons in the risk zone" study where a single home visit was evaluated and showed positive effects adls [ ] , frailty and fear of falling [ ] , life satisfaction and morbidity [ ] . this study was the only one, among phv interventions, to conduct a -year follow up at which some effects persisted and thus validates post-intervention effects [ ] . the positive effects of phvs in the "elderly persons in the risk zone" study are partly explained by the experiences of participants, who felt empowered and in control as a result of the information given and having the opportunity to discuss health-related matters with a qualified professional [ ] . however, these findings on long-term effects are in contrast to a previous phv trial that indicated that intervention effects remained only for as long as the home visits were ongoing [ ] , and thus, highlights the importance of long term follow-ups over. conflicting results regarding specific effects of pvhs and their health-economic effects have been reported also in a recent report from sbu enquiry service (swedish agency for health technology assessment and assessment of social services) about preventive home visits, also referred to from the swedish national board on health and welfare [ ] . in some studies, though, phvs have shown to be cost-effective while annual follow-up visits can be potentially even more costeffective. such findings have been established when conducting health economic analysis based on data from the elderly persons in the risk zone [ ] as well as in a previous swedish study including twice-annual home visits over a period for two years [ ] . despite the conflicting results on some outcome effects of phvs [ ] , they still can be considered a good alternative to group-based interventions, e.g. senior meetings, since not all potential participants can or like to engage in a group format. interventions including exercise or combining exercise with other components (e.g. medication review, guidance on nutrition, cessation of alcohol and smoking, home hazard assessment and modifications) showed to be promising for preventing falls. findings on these interventions showed improvements in different factors related to falls risk and physical functioning, e.g. muscle strength, mobility, balance or self-rated health [ , , , ] which could indirectly lead to fall reduction [ ] . positive effects were observed for both home-based [ ] and group-based interventions [ ] , regardless of whether they were shorter ( months) [ ] or longer ( year) in duration [ ] . furthermore, interventions including more frequent group sessions reported additional effects, such as improvement in motivation to continue with physical activity [ , ] , and perhaps consequently a reduction in injurious falls and fractures, as reported in two fall prevention interventions [ , ] . both interventions included balance exercise in combination with resistance/strength exercise provided over one year or longer, but varied in terms of content, number of sessions, and delivery approaches used e.g. multifactorial [ ] and multiple components [ ] . in line with evidence from a recent systematic review and metaanalysis, exercise-based interventions, aiming to improve balance and strength, are one of the most feasible and cost-effective approaches to prevent falls among older people living in the community [ ] . this approach has also been integrated into some current swedish guidance, on physical training, balance and more, issued from the national board on health and welfare in the form of training for professionals working with older people and fall prevention [ ] . however, effectiveness of exercisebased interventions is dependent on the uptake and longterm adherence [ ] . groups sessions led by professionals over a longer period ( year or more) seems to affect this aspect positively but can be costly, foremost in terms of human resources needed if provided to a large population of older people. since group training might not be the solution for all, other effective alternatives such as multifactorial interventions could work in these cases. also, multifactorial interventions have shown positive effects on preventing falls [ ] and could be considered an alternative to exercise-based interventions. nonetheless, no health-economic evaluation was identified for these interventions, and thus, still makes them less robust in terms of cost-effectiveness. while our results, indicate that there are several healthpromoting and preventive interventions that could improve health and well-being among community-dwelling older people, implementation needs to be considered, not only in relation to effects but also concerning the resources available, i.e. how limited resources can be used in a way that yields the largest health benefits [ , ] and other feasibility aspects such as reach in the population; a key factor for successful implemtation of research in practice. health economic evaluations, including evaluation of both costs and effects, can provide such important information. however, in this scoping review, only four health economic evaluations were identified, indicating a general lack of information to guide decision making. however, information regarding intervention content, e.g. duration and intensity of interventions, can at least provide some information about the resources required. regarding individual interventions, the study by dahlin-ivanoff et al. included one single preventive home visit requiring one and a half to two hours of a professional's time [ ] in contrast to the study by möller et al. in which a case management intervention, required at least one hour per month during a -month intervention of professional's time [ ] . similarly, for group-based interventions, the span for the time required was two hours for a one session discussion group [ ] , to two and a half hours per week over the course of one year [ ] . while these examples all include interventions with some positive effect, the time for which staff need to be allocated differs substantially. even though these examples lack information on other types of costs that can be affected by interventions (e.g. social care consumption), they provide some guidance on which resources are needed and the magnitude of staffing which is a central cost of a healthpromoting or preventive intervention [ ] . despite a growing literature of health-promoting and preventive interventions that have shown positive effects in well-controlled trials, the translation of such trials to practice has proven to be challenging [ ] . evidence has shown that feasibility or pilot studies are important to ensure effective practical implementation and to decrease threats to validity of health outcomes [ ] . however, in our literature search, there was a lack of piloting and feasibility studies. in the absence of feasibility or pilot studies, other reported aspects such as information on study participation rates and adherence could indicate the degree to which an intervention reaches out to the target population, and thus, increase chances of a successful translation of research evidence into clinical practice [ ] . reaching older people with health promotion is crucial for achieving a health impact for the whole population, but has also been shown to be challenging [ , ] . findings from all original studies, in this review, showed that approximately a third of the persons eligible declined to participate due to different reasons, i.e. being too sick or too healthy [ ] . qualitative data on experiences of participants could to some extent reveal why an intervention is or is not appealing to larger groups of older people, however, only a few studies on experiences of participants were identified in this review. while this review provides some guidance on which interventions have shown positive health effects in a nordic context, future research is needed on how to translate evidence into practice, e.g. through exploring alternative ways of reaching out to a larger population and incorporating support for behaviour change and adherence in the long-term. some examples of new promising approaches explored in this review were wii training [ ] and physical activity counselling [ ] . the digital approaches used through video training or self-care telephone calls are potentially feasible to be implemented considering the more limited resources required to implement them, e.g. the smaller number of direct personal contacts needed with providers of health care for older people while still resulting in positive effects. in light of the ongoing coronavirus pandemic and related measures of social distancing, the importance of addressing loneliness and isolation among older people is accentuated. digital approaches to delivering effective interventions could complement the challenge of isolation and the need to reach out to a higher number of older people. for example, using smartphones and tablets may be a potentially cost-effective way to increase reach in the population. at present, there is a big supply of smartphone applications for exercise, however, most lack evidence regarding their scientific and implementation validity in the older population. research in the area is, however, developing and one example is an ongoing large clinical trial on digital fall prevention in sweden [ ] . finally, in discussing the results of this study, it is notable that some important aspects of healthy ageing, were less frequently evaluated. only two studies focussed on mental wellbeing and social participation, one showed some effects in reducing loneliness [ ] and the other in improving general mental health [ ] . this gap in research has also been supported in other reviews, where promoting wellbeing and mental health have shown to be both effective and potentially cost-effective [ , ] , and should, therefore, be further researched. the scope of this review was broad. it included information on several factors extracted from all identified original and their related studies, and therefore provides an overview of the knowledge base in the field of healthpromoting and preventive interventions in the nordic countries. given the broad scope of this review, we choose to not include some information, e.g. data concerning when studies were performed or adverse events, which could be seen as a limitation of the study. data concerning when studies were performed would enrich information on the context and content of the interventions. however, the description of the study period, e.g. the period for the recruitment of participants, have not been reported consistently among all studies, therefore might not have produced many data. although a wide range of outcome effects was extracted, important information on adverse events was not extracted and beyond the scope of this study, guided primarily by the mrc guidelines. additionally, recent systematic reviews show that adverse events, for example, concerning fall prevention programmes seem to be rather poorly reported hence, would probably not make a significant difference in our conclusions, if included in the analysis [ , ] . another important factor to consider, which may lead to better developed and evaluated interventions, is if the studies have a theoretical foundation that may explain the causal link between intervention and outcomes [ ] . however, considering the already broad focus of this review, we choose to limit the presentation of results and not include data on the theoretical foundations for each intervention. furthermore, the quality of the included studies has not been evaluated the same way it would be assessed in a systematic review, meaning that the quality can differ between the studies. it is, however, in line with prisma guidelines on scoping reviews considering this step optional [ ] . yet a quality assessment of the included studies or grading of evidence might have led to stronger conclusions as a result of a reduction in uncertainty related to outcome effects. finally, this review did not include studies from the rest of the world, albeit such studies could have provided relevant information. the choice to do so was due to the importance of contextual factors concerning complex interventions [ ] . limiting the inclusion of interventions deriving from countries with similar welfare models and cultural context might increase chances of effective implementations of promising interventions. furthermore, research shows that there is is often a lack of information regarding the influence of the context when conducting and evaluating complex interventions [ ] . thus, more research on the influence of contextual factors in the effectiveness of certain interventions would add to the knowledgebase important for decision-makers. this scoping review, following the mrc guidelines, provides an overview of the evidence and evidence gaps of health-promoting and preventive intervention studies for community-dwelling older people in nordic countries hence, of importance for decision-makers, research councils and researchers. all interventions, besides one, showed positive effects on at least one health outcome, although the magnitude of effects and number of follow-ups differed substantially. given that evidence on effects alone are not enough information for decision-makers, information on other factors is needed. overall, there was a general lack of studies 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mental wellbeing of older people: making an economic case. australian e-journal for the advancement of mental health taking account of context in population health intervention research: guidance for producers, users and funders of research publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations our thanks to umeå university library for assisting with advice in performing the search strategy for the literature. we also thank shion gosrani (public health support officer at north tyneside council) for proofreading the manuscript for english language. authors' contributions sb was involved in designing the search strategy, executing the search strategy, assessing studies for inclusion, extracting, classifying and presenting the data, writing and editing the manuscript. mz was involved in assessing studies for inclusion, extracting, classifying, and presenting the data, writing, revising and commenting the manuscript. ms was involved in assessing studies for inclusion, contributing in presenting the data, revising and commenting the manuscript. sb, mz, ms read and approved the final version of the manuscript. work with this study was included in the ordinary work of the three authors. salary of the doctoral student is partially financed by umeå university's industrial doctoral school for research and innovation (ids). open access funding provided by university of umea. all data analysed during this study are included in this published article and its additional files. the search strategy is available in additional file . prisma extensions for scoping reviews-checklist is included in additional file .ethics approval and consent to participate not applicable. not applicable. author details key: cord- -ax v ak authors: griebenow, reinhard; mills, peter; stein, jörg; herrmann, henrik; kelm, malte; campbell, craig; schäfer, robert title: outcomes in cme/cpd - special collection: how to make the “pyramid” a perpetuum mobile date: - - journal: nan doi: . / . . sha: doc_id: cord_uid: ax v ak continuing medical education (cme) should not be an end in itself, but as expressed in moore’s pyramid, help to improve both individual patient and ultimately community, health. however, there are numerous barriers to translation of physician competence into improvements in community health. to enhance the effect cme may achieve in improving community health the authors suggest a kick-off/keep-on continuum of medical competence, and integration of aspects of public health at all levels from planning to delivery and outcomes measurement in cme. continuing medical education (cme) should not be an end in itself, but as expressed in moore's pyramid [ ] , help to improve both individual patient and ultimately community health. however, although the concept of "ascent to the summit" [ ] should not be misunderstood as meaning that only a few will be able to reach the peak of mount everest, we need to realise that there is no simple way of improving community health. as illustrated in figure , ( ) competence does not inevitably lead to performance: • due to national regulations and/or underfunding of (parts of) health-care systems, availability of treatment may be limited and/or unequally distributed in or between different countries [e.g. [ ] [ ] [ ] [ ] [ ] [ ] . resources to meet challenges such as covid- may be insufficient: shortages in staff, beds in intensive care units, respirators or personal protective equipment have uniformly become the responsibility of physicians [ ] [ ] [ ] [ ] [ ] [ ] [ ] . in particular in europe, the existence of more than health system jurisdictions in a relatively limited sized area, inevitably leads to a non-uniform picture of medical practice. ( ) appropriate performance will not always improve patient health due to: • variation in disease severity or even uncontrollable disease activity • variation in co-morbidities • lack of (informed) consent • patient non-compliance [e.g. [ ] [ ] [ ] • secular changes in risk [ ] or • regional/local differences in risk [e.g. [ ] [ ] [ ] • treatment of patient groups excluded from published studies [e.g. ] (e.g. elderly or patients with comorbidities), for whom the treatment effect has not been validated • health inequities [e.g. , ] considering community health adds a • quantitative dimension: in a theoretical scenario of, for example, a new pharmacological treatment, "level / -cme" would form the competence needed to start ("kick-off-competence", figure ). but targeting community health, requires that cme is informed by results of community health research. this research forms the evidence base, which will keep the process going, and will ultimately lead to improvement of community health ("keep-oncompetence", s. figure ). however, if community (and public) health research should systematically be considered for cme, some important issues have to be addressed: what is a meaningful improvement of community health that cme providers should promote as a benchmark in their cme activities? which role do surrogate endpoints play, in particular when a drug has been approved without evidence that it improves patient prognosis [ , ] ? so far public health research has often been hampered by restrictions in accessibility of data. this may change for the better with the more widespread use of electronic health records [ ] , though (at least in europe) data protection regulations may still interfere with access to patient data [ ] . physicians probably always intend that theoretically "all" their (eligible) patients should benefit from, e.g., a new treatment. therefore, is " %" the benchmark? this has never been resolved in health-care system research, and hagen et al. [ , ] . further investigation in this complex matter is needed clearly to delineate, to what extent community health effects can be attributed to physicians' primary medical motivation. • quantitative dimension: • worldwide, physicians have claimed professional autonomy in building patient-physician relationships [ ] . currently, professional autonomy is most often affected by regulatory actions and commercial interests, in particular the pharmaceutical and medical device industry. considering community health adds further to this list: though health insurance companies or hospital owners do not fall under the accreditation council for cme (accme) definition of a commercial interest [ ] , they definitely have a distinct interest in how health-care should be delivered, and part of the health-care system research is based on their data [e.g. ]. thus, similar to activities to build "kick-offcompetence" we need to define independence of cme also for "keep-on-competence". this includes criteria for institutional conflicts of interest, and bias in content provided by the institutions mentioned above [ ] ; the same also applies to regulators in state-driven health-care systems (e.g. nhs in the uk). • the maximum benefit for community health may only be achieved, if we optimise interdisciplinary, and interprofessional cme (and cooperation) [e. g. , ]. • community (and public) health research has its own methodological framework, which needs to be addressed in building "keep-on-competence", and • it may have very different sources of information compared to what makes up "kick-offcompetence", which need to be validated in their role to inform "keep-on-competence [e.g. ]. • selection of faculty in cme targeting community/public health should ideally include all stakeholders, including regulators, politicians, etc. (see also below) • but considering community health also reminds us of our role as expert citizens: back in , the german pathologist rudolf virchow, who had also been a member of the berlin city council and the prussian parliament for many years, had defined the relation between medicine and politics: "medicine is a social science, and politics is nothing more than medicine on a large scale". in the context of cme and community health this highlights that we as physicians have the responsibility to make transparent to the community, as well as their politicians, that treatment of the individual patient will only become effective, if structural changes within the community are also taken. this interdependence of patient care and community care has recently been succinctly demonstrated during the current covid- pandemic [e.g. , , [ ] [ ] [ ] . we may not be in the position of rudolf virchow, who (among others) initiated a sewer system for the city of berlin, and regulation on obligatory assessment of trichinae, binding for all butchers in prussia, but today we still struggle to determine the red line beyond which, we as individual physicians can no longer be able to compensate for deficits, which may only be resolved by political action. thus, cme targeting community health will inevitably be political, and should include all stakeholders in discussing progress and barriers in community health. this also highlights that choosing community health as top of the pyramid is appropriate, since for the large majority of physicians, the community is their professional reference level. however, there will remain issues which can only be resolved by political and subsequent legislative action. what are the implications for the concept of cme, and cme providers? currently, cme is often planned according to the assumption that repetitively updating kick-offcompetence (typically focused on knowledge dissemination), will ultimately have an effect on patient as well as community health. on the one hand there is some evidence for the impact of this strategy on physician performance and patient outcomes [ ] , but on the other hand this is not the appropriate strategy to address gaps in community health, and tends to create an attitude of unbalanced activism. it could thus be considered as "division of labour" to continue with "level - " cme activities and stimulate (other) providers to organise more "level - " cme. we should instead promote a different model: change the one-way ticket to a roundtrip, or: make keep-oncompetence the new kick-off-competence (s. figure ). to achieve this goal we need to: • define independence in community/public health research to ensure unbiased content • define which evidence is applicable to the particular community, i.e. introduce research methodology on a case by case basis into each cme activity [ ] • make community health part of the needs assessment, content selection, and definition of outcomes • include community health/public health experts within faculty • revise current time schedules, since including community health into cme will in most cases need more time than hitherto, also because • one of the biggest challenges for inclusion of community health into cme on a large scale will be that there is a substantial lack of data at the community level. thus, inclusion of community health matters will probably less often follow a teacher-learner scenario, but will more be a discussion between peers. • revise (if applicable) "knowledge tests" as evaluation of cme, and introduce items with an impact on community health, which can be the more specific as detailed data related to community health are available. • find new ways to integrate community health into cme with primarily international audience (e.g. by presentations of local experts through video conferencing) what are the implications for cme accrediting bodies? community health is the sum of the various forces working for and against community health. in targeting community health cme must therefore take responsibility for discussing all the pros and cons involved in improving community health. current definitions of how to conduct accredited cme theoretically cover aspects of community health [ ] . however, most cme currently does not deliberately address community health, since faculty, programme schedules, content, and outcomes, would have to be different in cme aimed at keep-on-competence. this would be accessible to external assessment (as part of the accreditation process), and thus even easier to assess than changes in language, management of data volume, or sources of information in cme [ , ] . worldwide, accrediting bodies are currently in the process of defining harmonised criteria for accreditation of cme [ ] . how to better implement community health-orientated cme might become part of this project. disclosure statements can be found under "supplementary material". achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities ascent to the summit of the cme pyramid can china's 'standard of care' for covid- be replicated in europe availability and prices of medicines for non-communicable diseases at health facilities and retail drug outlets in kenya: a cross-sectional survey in eight counties infections associated with resterilized pacemakers and defibrillators beschluss des gemeinsamen bundesausschusses über eine Änderung der arzneimittel-richtlinie (am-rl): anlage xii -beschlüsse über die nutzenbewertung von arzneimitteln mit neuen wirkstoffen nach § a sgb v -evolocumab geographic access to transcatheter aortic valve replacement centers in the usa. insights from the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry access to transcatheter aortic valve replacement under new medicare surgical volume requirements covid- : doctors' visas are automatically extended for one year covid- : medical students should not work outside their competency, says bma protect our healthcare workers what healthcare professionals owe us: why their duty to treat during a pandemic is contingent on personal protective equipment (ppe) whose life to save? 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(jecme). zjec quality of care after acute coronary syndromes in a prospective cohort with reasons for non-prescription of recommended medications prescription fill patterns for commonly used drugs during the covid- pandemic in the usa covid- -a reminder to reason time course of change in prescription behaviour after targeted continuing medical education in a closed loop system of repeated standardised documentation and feedback use of secondary prevention pharmacotherapy after first myocardial infarction in patients with diabetes mellitus trends in early aspirin use among patients with acute myocardial infarction in china decade-long trends ( to ) in the use of evidence-based medical therapies at the time of hospital discharge for patients surviving acute myocardial infarction the effect of malpractice reform on emergency department care why aren't physicians prescribing more buprenorphine? comparison of payment changes and choosing wisely recommendations for use of low-value 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new york city boroughs associations between built environment, neighborhood socioeconomic status, and sars-cov- infection among pregnant women sars-cov- positivity rate for latinos in the baltimore-washington, dc region the impact of cme on physician performance and patient health outcomes: an updated synthesis of systematic reviews cologne consensus conference: standards and guidelines in accredited cpd what does cme accreditation stand for? key: cord- -mzn zk authors: challen, kirsty; bentley, andrew; bright, john; walter, darren title: clinical review: mass casualty triage – pandemic influenza and critical care date: - - journal: crit care doi: . /cc sha: doc_id: cord_uid: mzn zk worst case scenarios for pandemic influenza planning in the us involve over , patients requiring mechanical ventilation. uk planning predicts a % occupancy of current level (intensive care unit) bed capacity. critical care planners need to recognise that mortality is likely to be high and the risk to healthcare workers significant. contingency planning should, therefore, be multi-faceted, involving a robust health command structure, the facility to expand critical care provision in terms of space, equipment and staff and cohorting of affected patients in the early stages. it should also be recognised that despite this expansion of critical care, demand will exceed supply and a process for triage needs to be developed that is valid, reproducible, transparent and consistent with distributive justice. we advocate the development and validation of physiological scores for use as a triage tool, coupled with candid public discussion of the process. it is widely accepted that conditions exist for the evolution of a new strain of influenza virus with the potential to cause a human pandemic [ ] . the biggest challenge in planning for an influenza pandemic is the range of unknown factors; its nature and impact cannot be fully predicted until the pandemic virus actually emerges. those planning for a pandemic must, therefore, work from a number of assumptions based on knowledge gained from previous pandemics and scientific modelling of a range of potential scenarios. the uk pandemic influenza plan [ ] sets out a range of possible scenarios for clinical attack rates and case fatality rates during a pandemic, including the potential for more than one wave. the base scenario assumes a clinical attack rate of % and a case fatality rate of . %, giving rise to , excess deaths in the uk. a reasonable worst case scenario involves a cumulative clinical attack rate of % with . % case fatality, causing , excess deaths. similarly, the us department of health and human services predicts that in a "moderate" scenario based on a virus with -like pathogenicity, , will require hospitalisation and , ( . %) will require ventilation. they also outline a "severe" -like scenario with . million hospitalisations and , patients requiring ventilation [ ] . an influenza pandemic will undoubtedly create a major increase in demand for critical care services. the majority of uk hospital intensive care units (icus) are already operating at > % bed occupancy. integral to the success of any emergency planning strategy is 'surge capability', incorporating the ability to scale up the delivery of appropriate specialist care to those that require it [ ] . modelling of the impact of an influenza pandemic on uk critical care services has been carried out using the flusurge . programme developed at the us centers for disease control [ ] . with simulation of an -week epidemic and % attack rate the demand for critical care beds from patients with influenza would represent % of current combined level (highdependency unit) and level (icu) bed capacity, and % of current level capacity [ ] . even allowing for optimistic estimates of other modulating factors ( % reduction in icu demand with use of neuraminidase inhibitors and % upgrade of level to level beds), level bed occupancy due to the pandemic would remain at %. furthermore, occupancy of level beds by 'flu patients' was unsustainable at approximately % in terms of care for other patients even in the most optimistic conditions. sars outbreak, up to % of cases were admitted to icu, % were mechanically ventilated and day mortality for ventilated patients was % [ ] . in singaporean sars patients admitted to icu, % developed ards [ ] . properly constructed plans for the delivery of critical care during an influenza pandemic must include the ability to deal with excessive demand, high and possibly extreme mortality, and the risk to the health of critical care staff. the consequences of a pandemic, both in terms of numbers of patients and the effect on the healthcare system, are likely to precipitate a 'major incident' where special arrangements are needed to manage the system while it is under extreme pressure. it is anticipated that there will be an overwhelming demand for critical care services, not only for respiratory support through mechanical ventilation but also for a full range of care to manage multi-organ failure. assuming that the next pandemic derives from the h n strain, the epidemiological evidence to date suggests extremely high mortality and, although not precisely quantifiable, a significant risk to health care workers. both of these will undermine the ability to deliver critical care to influenza patients even before consideration is given to the duty of care to other critically ill patients. coherent incident response requires a robust command and control structure, with the ability to make rapid informed decisions across an organisation and also across a health economy. in the uk, health incident management is based on a 'medallion' structure, with gold, silver and bronze corresponding to strategic, tactical and operational command levels [ ] . north american and asian health institutions tend to use the hospital emergency incident command system [ ] . the common theme in both systems is a clear command and control structure with which healthcare staff should be familiar [ , , [ ] [ ] [ ] [ ] . their generic hierarchical structure allows application to a wide range of incidents whilst retaining familiarity gained from training and exercises. the importance of familiarity with the command and control structure was highlighted in a recent delphi study [ ] and european survey [ ] . critical care contingency planning guidance from the uk department of health places an expectation on providers to expand their level bed capacity by a factor of but no more. provision of full multiorgan level support is recognised to be unrealistic, but principally respiratory support is felt to be achievable. cancellation of elective surgery to minimise alternative sources of demand for critical care, upgrading level to level facilities and recruitment of theatre recovery areas and even operating theatres may allow expansion of icu-like care capacity. staff in these areas already have the competencies to manage sedated patients and those receiving respiratory support. escalating their clinical role should require relatively limited focussed training [ ] . other staff may need to be redeployed and receive training in the management of critical care patients to support fully trained staff, permitting a dilution of the standard critical care nurse to patient ratio [ ] . flexibility around dependency level and staff experience will be required [ ] . the expansion of icu capacity to provide critical care in other areas will require the pre-emptive identification, tracing and maintenance of all usable equipment and potentially the stockpiling of key items to allow for rapid up-scaling of activity in response to demand. it is likely that there will be some variability in the prevalence of influenza across the country during a pandemic wave, with peaks in demand staggered across geographical areas. it may be possible to disperse some of the patient load by interfacility transfer if this occurs to any significant extent. the expansion of icu facilities during the sars epidemic in hong kong and singapore was recently described [ ] . infection control is recognised as an overriding priority for the delivery of critical care, including the ability, in the early stages, to cohort cases. this should ideally include the use of separate entrances and exits, isolation rooms with negative pressure ventilation and dedicated separate healthcare staff. the toronto experience identified secondary cases of nosocomial transmission of sars in icu from an initial index case before infection control measures were introduced. even following the introduction of extensive protective equipment, nine healthcare workers developed sars as a result of being present in the room during the intubation of a single patient. in terms of personal protection, planning and practice in the donning of protective equipment (ppe) and prior fit testing is essential [ ] . the practicalities of being able to manage patients when fully attired must be understood and consideration given to the fact that any procedure or task will take longer. this will impact on care efficiency and the staff to patient ratio. while beds can be scaled up and extra areas recruited to provide critical care, without trained staff the planning will be ineffective. staff illness rates and the risk to staff must be factored into the planning process. in the uk, staff illness has been estimated at % with work absences of up to days [ ] . normal working patterns may need to be revised and facilities provided for staff to stay on site rather than go home to their families. staff absence tends to be greater the longer special circumstances apply and the greater the impact on the lives of the staff [ ] . the preventive effectiveness of neuraminidase inhibitors may make focussed chemoprophylaxis a strategy for reducing staff illness in critical care areas [ ] . the evolution of a new pandemic strain of influenza will inevitably result in a major increase in demand for critical care services. it is likely that these services will rapidly reach their capacity and even their contingency arrangements for extended facilities will be overwhelmed. excessive demand where resources are finite creates an ethical dilemma and many emergency plans apply a utilitarian approach of 'best care for the greatest number' [ ] . there is a legitimate debate about how limited capacity can best be utilised, but a number of themes are recurrent. there needs to be a legal and ethical framework for the process decided in advance, the rationale for triage should be fair and transparent and it should meet the principles of distributive justice [ ] [ ] [ ] . triage can conflict with human rights legislation and even humanitarian laws but 'accountability for reasonableness' can temper the disagreements about priority setting [ ] . the decision making process needs to be valid and reproducible. although there are a number of triage systems available for mass casualty incidents, there has been little validation of any of them in the field [ ] , and what there has been relates to 'big bang' single incidents and the apparent unreliability of triage [ , ] . while it does not need to be explicit ahead of time, the decision thresholds should be based on both the cumulative evidence about the disease process and prognosis, and the number of patients and severity of illness making the demands on the service [ ] . in effect, triage may result in a gradual degradation of care with the increasing scale of the incident and become a 'societally mandated do not resuscitate order'. on these grounds the process needs to be carefully considered at an appropriately senior level and applied consistently [ ] . allowing for the utilitarian approach, it is recognised that in mass casualty incidents, the standard of care for all patients, including those not immediately related to the incident, may need to be adjusted and reduced. while this may infringe individual rights, the higher ethical principle of 'wellness of society as a whole' allows for the direction of resources to those where it is felt most effective. it may also allow for an expansion in the scope of practice of non-physicians [ ] . it may be unrealistic and impractical to expect that senior medical intensive care staff will make all decisions regarding instituting critical care and there will be a need to empower more referring general clinicians to do so. this is at odds with the need for decision making by the most senior person [ ] and will require a change in practice for many clinicians; it is not current practice in the uk. the use of track and triage protocols will be essential to direct this decision making and ensure its consistency. ardagh [ ] has developed a set of pragmatic questions for the clinician facing acute problems of resource allocation; the only point lacking in his assessment process is a tool for the 'ranking' of patients in terms of likelihood of benefit from the limited resources. we believe that the basic criteria for a system for triage to critical care in a pandemic are fourfold; it should identify patients sick enough to require higher level care at some stage in their illness, it should be able to recognise those patients who are too acutely or chronically unwell to benefit from critical care, it should be consistently applicable by healthcare professionals and support workers from a variety of backgrounds within the constraints of the pandemic and should ideally also be scalable to reflect any mismatch between need and capacity. in order to fairly allocate resources across both flu and non-flu patients it should also be disease non-specific and allow prognostic comparisons across disease categories. a number of scoring systems have been advocated for use in a pandemic. the uk department of health currently recommends a six-point pneumonia severity score [ ] . although us guidelines emphasise the importance of triage in primary influenza, specific tools are only recommended for assessment of post-influenza bacterial pneumonia [ ] . the majority of available potential scores were developed as mortality indicators and perform less well for predicting critical care usage. amongst icu admissions with community-acquired pneumonia in massachusetts in to , / scored curb- or (that is, low risk) and / were classified as psi (pneumonia severity index) class iii (intermediate risk) [ ] . even amongst patients with pneumonia included in the prowess study, only . % were psi class iv or v, and only . % had a curb- score of or above [ ] . there is no guarantee that pandemic influenza will be primarily pneumonic in its presentation; case reports have documented h n influenza presenting with diarrhoea [ , ] and coma [ ] and a world health organisation summary has described absence of respiratory symptoms in a number of cases [ ] . the utility of disease-specific pneumonia scores may also be limited by mortality from comorbidities such as cardiovascular disease. a number of intensive care scoring systems have demonstrated their power in using physiological derangement to predict mortality or higher resource requirements, whatever the presenting diagnosis [ ] [ ] [ ] [ ] [ ] . physiological scores have also been demonstrated to be good predictors of requirement for higher level care on hospital wards [ ] , in medical assessment units [ , ] and in the emergency department [ ] . we have demonstrated that a purely clinical score incorporating acute physiological derangement and chronic health and performance status can reliably predict requirement for critical care [ ] . it is inevitable that if an influenza pandemic reaches the scale of some predictions, some patients who, in normal circumstances, would benefit from critical care will not be offered it. critical care triage will need to evolve from a process of identifying cases who need high level care to one that determines those patients most likely to benefit from the limited resources available and distinguishes them from those where care is likely to be futile. this is recognised by the emergency medicine community and the us administration in terms of disaster triage [ , ] . the american thoracic society adopted the utilitarian principle a decade ago, stating that "the duty of health providers to benefit an individual patient has limits when doing so unfairly compromises the availability of resources needed by others" [ ] . the problem now facing policymakers and clinicians is defining a process for resource allocation that meets the requirements of distributive justice and accountability for reasonableness [ ] . as the working group on emergency mass critical care of the society for critical care medicine recognised, "an ideal triage system is based on data collected at hospital admission, requires little or no laboratory testing, and has been proven to predict hospital survival" [ ] . the ontario ministry of health long-term care working group have courageously taken the first steps in defining a triage protocol for critical care [ ] and their use of serial sequential organ failure assessment (sofa) scores to place a ceiling on care provided to non-responding patients is to be supported. however, it is unlikely to be feasible for all patients to have a trial of inotropes and/or ventilation and some way of screening out the sicker patients at ward/floor level will be required. we are not aware of the use of objective prognostic scores to allocate or refuse critical care resources at present and indeed most research demonstrates the ad hoc nature of admission decision-making [ ] . however, if, as is likely, review by experienced critical care physicians is impractical, decision support will be required for the non-critical care specialist. emergency physicians, for example, had a positive predictive value (ppv) of only % in identifying those with a low chance of survival, as opposed to critical care fellows (ppv %) and the mortality probability model (mpm ; ppv %) [ ] . sofa scoring has previously been demonstrated on a multinational basis to predict high risk of mortality (a sofa score of over was . % specific for mortality) [ ] . other critical care scoring systems show comparable performance in mortality prediction; discrimination as measured by area under receiver operator characteristic (roc) curve was . to . for acute physiology and chronic health evaluation iii (apache iii) [ ] [ ] [ ] [ ] , . to . for simplified acute physiology score ii (saps ii) [ , , ] , and . for the multiple organ dysfunction score [ ] . however, calibration of these scores to give absolute risks of mortality has not always been reliable [ ] and has required customisation for international use [ , ] . concentrated work is clearly required to amend and validate existing scoring systems so that they are suitable for use as triage tools. we suggest that this should be done on two levels. while disease specific scoring systems are valuable and should continue to be refined, there is a need to develop an appropriately generalisable scoring system for as unselected a group of patients as possible. to have the discriminating power, it will need to take place on a multicentre or, preferably, on a multi-national basis. it is a general principle of major incident planning that procedures should not be changed at precisely the moment when the system or institution is under its greatest stress, so planning for pandemic flu needs to make use as much as possible of systems and procedures already in place. development of a triage system and tool needs to be accompanied by planning for hospital command and control (to dictate scalability as related to available resources) and by training for staff whose roles may change. researchers, clinicians and policymakers in the field need to analyse systems and scores already in existence and improve and validate them as triage tools (though this may not be the purpose for which they were originally developed). at the same time ethical principles require transparency and consistency in the decision-making process, and involvement of public in its development. in reality, perhaps the question we need to address is the action required when critical care services are overwhelmed. the scalability of triage tools may aid in decision making by objectively altering the threshold for admission to critical care. however, the time may come when we need realistically to evaluate the effectiveness of critical care in influenza. if survival with the benefit of critical care is marginal (for example, < %) and there is a significant cross-infection risk, perhaps critical care should then close and concentrate its efforts on outreach to other areas, including wards. direction and support from professional bodies and health departments will be required to support the 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comparison of severity of illness scoring systems for intensive care unit patients: results of a multicenter, multinational study characterization of intensive care unit patients using a model based on the presence or absence of organ dysfunctions and/or infection: the odin model simplified acute physiological score for intensive care patients the use of maximum sofa score to quantify organ dysfunction/failure in intensive care. results of a prospective, multicentre study a physiologically-based early warning score for ward patients: the association between score and outcome the simple clinical score predicts mortality for days after admission to an acute medical unit validation of a modified early warning score in medical admissions the association of sepsis syndrome and organ dysfunction with mortality in emergency department patients with suspected infection physiological-social score (pmews) vs. curb- to triage pandemic influenza: a comparative validation study using community-acquired pneumonia as a proxy population-based triage management in response to surge-capacity requirements during a large-scale bioevent disaster bioethics task force: fair allocation of intensive care unit resources augmentation of hospital critical care capacity after bioterrorist attacks or epidemics: recommendations of the working group on emergency mass critical care development of a triage protocol for critical care during an influenza pandemic priority setting in a hospital critical care unit: qualitative case study prediction of poor outcome of intensive care unit patients admitted from the emergency department use of the sofa score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter prospective study comparison of acute physiology and chronic health evaluations ii and iii and simplified acute physiology score ii: a prospective cohort study evaluating these methods to predict outcome in a german interdisciplinary intensive care unit comparison of multiple organ dysfunction scores in the prediction of hospital mortality in the critically ill mortality discrimination in acute myocardial infarction: comparison between apache iii and saps ii prognosis systems community-wide assessment of intensive care outcomes using a physiologically based prognostic measure the influence of length of stay in the icu on power of discrimination of a multipurpose severity score (saps) multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome the effect of casemix adjustment on mortality as predicted by apache ii the performance of saps ii in a cohort of patients admitted to italian icus: results from giviti. intensive care med disaster management edited by j christopher farmer.other articles in this series can be found online at http://ccforum.com/articles/ theme-series.asp?series=cc_disaster key: cord- -sabmw wf authors: el-shabrawi, mortada; hassanin, fetouh title: infant and child health and healthcare before and after covid- pandemic: will it be the same ever? date: - - journal: egypt pediatric association gaz doi: . /s - - - sha: doc_id: cord_uid: sabmw wf background: the novel corona virus disease (covid- ) current pandemic is an unpreceded global health crisis. not only infection of infants, children, and adolescents is a concern for their families and pediatricians, but there are also other serious challenges that should be properly identified and managed as well. main body: we have to identify and assess the different factors that have either direct or indirect effects on child health and healthcare due to covid- pandemic and focus on the serious effects. it is easily realized that there are many challenging problems associated with covid- with short-term effects that already appeared and need urgent solutions and long-term effects that are not yet well apparent and have to be searched for and properly addressed. conclusions: covid- crisis has lots of impacts on child health and child healthcare, not only from the medical aspect but also from the social, psychological, economic, and educational facets. all these adverse implications have to be identified and dealt with on individual bases approach in the short and long term. since reporting of the first index cases of infection with the novel severe acute respiratory syndrome corona virus (sars-cov- ) in wuhan (hubei, china) on december , the whole world has changed very rapidly and dramatically. on january , the world health organization (who) has declared the novel corona virus disease (covid- ) as a global health emergency, and shortly thereafter on march , it was declared as a pandemic [ ] . covid- pandemic proved rapidly to be a major international medical problem that has many sequences on infants, children, and adolescents. worldwide, concerted efforts must be exerted in order to identify the huge problems and impacts the pandemic has created that affect child health and child healthcare, and plan prompt solutions for them. all the news, reports, and experiences from the four corners of the world are indicating that infant and child health and healthcare systems before the covid- pandemic have been changed to variable degrees and will probably never be the same after the pandemic in many aspects for extended periods of mankind life. covid- is uncommon to cause marked clinical symptoms in healthy children as compared with adults. however, asymptomatic children are able to transmit the virus to their adult contacts, and very young infants and children (as well as those with underlying comorbidities) are at increased risk to manifest severe illness [ ] . covid- is a droplet infection that spreads rapidly to the unprotected contacts from an infected person. the infectious virus can persist on contaminated surfaces for variable times. the risk of transmission via touching contaminated paper is low, while respiratory and fecal specimens can maintain infectivity for quite a long time at room temperature. sars-cov- could exist in the air in poorly ventilated buses for at least min. absorbent materials like cotton are safer than non-absorptive materials for protection from viral infection [ ] . as children are less likely to present with serious symptoms, they may have nasal congestion, sore throat, muscular and bony aches, abdominal pain, vomiting, or diarrhea [ ] . in children, common circulating corona viruses can cause common cold symptoms such as fever, rhinitis, otitis, pharyngitis, laryngitis, headache, bronchitis, bronchiolitis, wheezing, pneumonia and, in up to % of cases, gastrointestinal symptoms (which are more common in children than adults) [ ] . some recent studies have shown that there is limited spread among children and from children to adults [ ] [ ] [ ] . the most common manifestations in infected adults include fever, tiredness, and a dry cough [ ] . in the majority of infected adults, the symptoms are mild, and more than % completely recover. however, the remainder may become seriously ill and some may die. more severe symptoms include difficulty in breathing, pneumonia, acute respiratory distress syndrome, and septic shock leading to multiple organ failure such as heart, liver, and kidney failure [ ] . until now, there is limited evidence that maternal vertical transmission can occur, and newborn infection if occurs is due to perinatal transmission rather than prenatal [ ] . it was also found that there is no transmission of the virus through breast milk; therefore, cessation of breast feeding from covid- -infected mothers is not recommended, and infected mothers are strictly advised to follow preventive precautions such as handwashing, cleaning the breast before feeding, and using masks during breast feeding [ ] . laboratory findings from children are rather similar to those in adults and include a white blood cell count that is typically normal or reduced with decreased neutrophil count and/or lymphocyte counts. thrombocytopenia may occur. c-reactive protein (crp) and procalcitonin levels are often normal. in severe cases, elevated liver enzymes, lactate dehydrogenase levels, as well as an abnormal coagulation and elevated serum ferritin and d-dimers have been reported [ ] . radiologic findings in children are similar to those of adults. chest radiography mostly shows bilateral patchy airspace consolidations mainly at the periphery of the lungs, peri-bronchial thickening, and ground-glass opacities. chest computed tomography (ct) scans mostly show airspace consolidations and ground-glass opacities [ ] . until now, there is no definitive evidence-based drug therapy for covid- neither in adults nor in the pediatric populations. current management for covid- is largely symptomatic and supportive care. supportive measures include sufficient fluid and caloric intake, antipyretics, oxygenation, anticoagulants, and prophylactic antimicrobial therapy to prevent superadded bacterial or fungal infections. the aim is to stabilize the clinical condition and prevent further deterioration as organ failure and secondary infections. it is better for children with mild symptoms to stay at home under medical supervision. if the child condition is deteriorating, then the child should be hospitalized as advised by the treating pediatrician [ ] . confirmation of the information credibility is essential for healthcare professionals and the public in general. during crisis, rumors and false stories, misleading information, and unreliable data are sadly shared via social media leading to a state of instability and uncertainty among the community members and causing mistrust in the healthcare providers [ ] . pediatricians and all other healthcare team must be cautious about starting therapies based on news or social media reports and should rely on trusted sources of evidence-based information from reliable credited sources of updated information and share those with the families in their care [ ] . it is equally important that families be aware that many of what is called sham remedies have been promoted to the public. many sham treatments have been widely disseminated on social media. these include, for example, drinking warm water, gargling with saline or garlic, drinking lemon juice with honey or black seeds, use of specific homeopathic or alternative medicines, and drinking specific alcoholic drinks. none of these remedies have been proven effective in prevention or treatment, and some have been shown to be harmful, and therefore, should not be recommended [ ] . healthcare facilities all over the world became suddenly overwhelmed by unexpectedly treating thousands of covid- patients at the same time. this has created marked congestion and an unpreceded chaos in the healthcare facilities especially in the populated regions. this has its adverse impacts and many people and particularly infants and children were and still (until the time of writing this manuscript) unable to get the proper medical care they actually need. suggested short-term measures have been proposed to the countries all over the world by the who in response to covid- pandemic. a comprehensive guidance to countries on the types of actions and adjustments needed to support the response [ ] . there is an urging challenge of how to provide the required healthcare needed by infants and children in due time and place avoiding the possibility to catch sars-cov- infection if they go to seek medical advice at hospitals or healthcare facilities. the mandatory precautions including the fundamental physical distancing and infection control requirements will affect the traditional routine medical care beside that many parents are afraid to leave homes or do not want to take their child to a medical care facility with a possibility to be infected from other sick children. therefore, care givers are encouraged to share their worries and information with their pediatricians via phone calls, e-mails, or other social media applications [ ] . telemedicine has been dramatically exploited in the past few months as a useful tool for long-distance clinical care more than -folds what has happened to it during the past decade. telemedicine can be used for education, counselling parents, and health management, and its role is professionally enlarging in many regions such as the usa and europe, but awaiting further regulatory approvals in other regions such as in egypt [ ] . telemedicine may be of limited practical application in some low-income countries where resources are limited due to technical, economic, cultural, or geographical factors, but yet it needs to be tried as an alternative to face-to-face communication to get the required medical advice especially in the straight forward medical problems and concerns. with appropriate attention and caution for some issues such as patient safety, confidentiality, and suspected missed clinical information, telemedicine can be an effective way to help patients during the present covid- pandemic [ , ] . it is estimated that millions of infants and children worldwide have just missed and will continue to miss their required essential vaccinations with a fear that some vaccine preventable diseases (vpd) may come back as measles and poliomyelitis. the who has stressed the importance of maintaining the essential health services during covid- pandemic and identified immunization as a core health service that must be offered to the target chirdren [ ] . special planning and extra ordinary efforts are required to be applied quickly for vulnerable pediatric populations at increased risk of morbidity and mortality as refugees and children under custody. however, it was advised that mass vaccination campaigns should be temporarily halted or postponed to follow recommendations on maintaining proper physical distancing and infection control precautions required to combat covid- transmission during such campaigns [ ] . covid- crisis has forced governments to close nurseries and schools as well as sports' clubs and gardens. it is not allowed to travel to areas where recreations can be practiced. children are not allowed to meet their friends and other relatives. they are locked down at their houses having the same repeated daily routine. similar to adults, children are likely to suffer anxiety, fear, and other psychological manifestations. children may experience negative feelings and thoughts such as fear of being hospitalized, taking injections up to a fear of their family member loss, or even their own death. this may present as behavioral disturbances, loss of appetite, sleep problems, nightmares, and many other stress-related disorders. the adolescents are also affected but to a lesser extent than children as adolescents seem to express an excellent ability to manage situations of insecurity and have a better adaptation with the changing circumstances [ ] . in the wake of the global lockdown, schools are closed. children are not only obliged to stay at home for longer hours and become more vulnerable to domestic violence and other sorts of child abuse, but also there is an anticipated decrease in reporting of child maltreatment cases which includes sexual, physical, and emotional abuse. adding other adverse factors as parental unemployment and economic burdens will be negatively reflected on providing a safe healthy environment for the children to stay in. it is clear now that the measures which have been taken to control the spread of covid- are causing what may be called a "secondary pandemic" of child neglect and abuse [ ] . the living conditions in refugee camps, crowded reception centers, or detention facilities are unfortunately a very suitable environment for covid- spread. there is lack of proper healthcare services and sanitary precautions beside the suboptimal physical and medical status of the children at such places. displaced children are among those with the most limited access to prevention services, testing, treatment, and other essential support. in addition, the pandemic and containment measures are likely to have negative consequences for their safety and education, which were pre-carious even before the outbreak of the disease [ ] . many families are struggling with their daily lives. parents and care givers being out of work or even have already lost their jobs during the pandemic do not have enough financial resources to cope with the many changes occurring. on the other hand, the basic needs of infants, children, and adolescents must be fulfilled. with the world economy sagging into recession, it is feared that this hardship will remain and probably increase over the coming months, if not years [ ] . being more vulnerable to catch infections, children suffering of chronic diseases are at high risk to get covid- infection. those children are suffering of marked decrease of their protective mechanisms and inner barriers to combat infections. not only that, but also if they developed covid- infection, there will be a potential increased risk of deterioration of their clinical status. prevention is the principal key factor for those children. they should not catch covid- at the first place. they must strictly stay at home avoiding any possibility to catch infection. if covid- infection is suspected, they must seek medical advice promptly. infants < year of age and children with certain serious underlying conditions appear to be at greater risk for severe disease. the most commonly reported underlying conditions in covid- pediatric patients were chronic pulmonary disease, cardiovascular disease, immunosuppression (e.g., related to cancer, chemotherapy, radiation therapy, hematopoietic cell or solid organ transplant, and high doses of glucocorticoids) [ ] . the overwhelming current covd- ongoing disaster should not make us forget other serious medical and surgical diseases and emergencies that children may suffer. pediatricians and pediatric hospitals must be prepared to provide rapid, efficient, and safe medical management accordingly. in its recent position statement, the international pediatric association (ipa) has strongly recommended that the primary care and hospital resources for children must be maintained during the current covid- pandemic, in order to ensure addressing the child and adolescent health priorities and providing required health management services for children with more severe covid- manifestations [ ] . the mandatory lockdown and inevitable social distancing measures due to the covid- pandemic has forced the governments in many countries to close nurseries, child care centers, schools, training centers, and higher education facilities as universities and institutions. these closures have affected millions of students worldwide not only retarding their educational aspects, but also adversely affecting their emotional status and well-being. whenever the schools are reopened, the protection of children and educational facilities is particularly important. precautions are necessary to prevent the potential spread of covid- in school settings; however, care must also be taken to avoid stigmatizing students and staff who may have been exposed to the virus [ ] . staying at home for long time and closure of sports clubs and lack of physical activities may eventually result in marked weight increase in children and adolescents and development of obesity problem with all its negative consequences. pediatricians have to alert parents and care givers for this increasing heath problem during lockdowns. on the other hand, in many developing countries, the opposite may occur; the economic adverse effect of covid- may result in marked decrease in the families' abilities to ensure enough food supplies for their children resulting in their suffering of undernourishment. nutritious food intake has to be offered to every individual. proper nutrition and hydration are vital for health these days. intake of more water and avoiding sugars are essential. children and adolescents should eat a variety of fresh and unprocessed foods every day to get enough vitamins and minerals [ ] . what is expected after covid- pandemic is over? the covid- pandemic caused an unpreceded disturbance in the global health systems. humanity is hopeful that it may come to an end sooner rather than later especially if an effective antiviral treatment(s) and/or vaccine(s) are developed rapidly. until that moment, prevention of infection and symptomatic and supportive treatment are the best to do. therefore, revising infant and child health and healthcare plans, and prioritizing the healthcare projects are essential and mandatory issues as the world will never be the same again. both globalization and urbanization that have been two of the world's most powerful drivers in the past few decades are anticipated to be reversed by covid- leading to increasing the distances among people and between countries due to border closures and restricted international travel [ ] . so far, the covid- crisis has had a great impact on child health and healthcare all over the world, not only from the medical aspect, but also from the social, psychologic, economic, and educational aspects. all these implications have to be identified and dealt with properly to avoid their short-and long-term consequences on an individual bases approach. world health organization (who). 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( ) covid- databases and journals coronavirus disease (covid- ) advice for the public: myth busters ) health systems governance and financing & covid- available at global telemedicine implementation and integration within health systems to fight the covid- pandemic: a call to action in-person health care as option b virtually perfect? telemedicine for covid- guiding principles for immunization activities during the covid- pandemic the psycho-social effects of covid- on italian adolescents' attitudes and behaviors is a secondary pandemic on its way? institute of health visiting united nations high commissioner for refugees ( ) joint statement as covid- pandemic continues, forcibly displaced children need more support than ever us centers for disease control and prevention (cdc). ( ) coronavirus disease cdc covid- response team ( ) coronavirus disease in children -united states promoting and supporting children's health and healthcare during covid- -international paediatric association position statement world health organization (who). ( ) schools & covid- -control & prevention guide available at the world economic forum covid action platform. the post-covid- world could be less global and less urban springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors stated no acknowledgement. both authors contributed equally in all steps of preparation of this work. the author(s) read and approved the final manuscript. the authors declared that they receive no funding whatsoever for this work. ethics approval and consent to participate not applicable the authors are giving their consent for publication. the authors declared that they have no conflicts of interest.author details faculty of medicine, cairo university, cairo, egypt. misr international university, cairo, egypt.received: june accepted: july key: cord- -y tavcjb authors: cohen, jennifer title: covid- capitalism: the profit motive versus public health date: - - journal: public health ethics doi: . /phe/phaa sha: doc_id: cord_uid: y tavcjb market incentives in capitalist economies and public health requirements are contradictory. in the covid- pandemic, market-rewarded self-interested behavior has been exposed as a source of mortality and morbidity. profit-motivated behaviors can keep people from accessing necessities for health thereby harming individuals and possibly damaging population health. the profit motive can also undermine healthcare system capacity by maldistributing goods that are inputs to healthcare. furthermore, because profit-seeking is economically rational in capitalism, capitalist imperatives may be incompatible with public health. the ways markets misallocate resources provide a rationale for state responsibility for health, which is a public good. responsibility for health, described as-at least potentially and partly-an individual pursuit, per the liberal tradition, remains a key topic for ethicists in public health literature. critics typically point to social determinants of health and other contextual and structural factors that lie outside of individual control (holm, ; bell and green, ; brown et al., ; levy, ; mackay, ; verweij and dawson, ; . some discussions pose responsibility for health as lying either with individuals because of their behaviors or with the government because of those circumstances beyond individual control. this individualversus-state framing obscures the mechanism through which most individuals, directly or not, secure the necessities of life in a capitalist economy: the market. a careful review of markets should inform such discussions; individuals can hardly be responsible for their health if the market system does not provide access to inputs to health. markets can misallocate resources for a number of reasons-behavioral, institutional and structuralrelated to supply and demand. for example, lack of income impedes access to goods and services for those unable to pay for, or in economic language, to effectively demand, the necessary commodities in the marketplace (holm, ; cohen and rodgers, ) . as verweij and dawson ( ) note, within-population inequalities offer justice-based reasons for the state to take responsibility for health. another reason to look closely at markets is the profit motive, a supply-side behavioral force, which provides a different rationale for deindividualizing responsibility for health in capitalist economies. i argue that profit-motivated behaviors keep individuals from accessing necessities and undermine public health and health systems as demonstrated during the covid- pandemic. furthermore, because such behavior is economically rational in capitalism, capitalist imperatives may be incompatible with public health (smith, ) . in times of crisis, such as the covid- pandemic, it can be tempting to view price-gougers, hoarders and those who violate quarantine orders as self-interested jerks, with antisocial or even sociopathic behavior. however, focusing on individual 'rule-breakers' elides social and economic context (roy, )-capitalism incentivizes profit-seeking at significant cost to public health. these people are not rule-breakers; their behavior is consistent with capitalist logic. antisocial entrepreneurialism occurs at all levels: from a student charging classmates for single-squirts of hand-sanitizer (harvey, ) , to people stockpiling and unapologetically reselling cleaning wipes on craigslist and facebook marketplace (tiffany, ) , to drug companies jacking up prices for medications like insulin (thomas, ) . in the usa, the federal government failed to take responsibility for regulations, leaving a void to be filled by private entities, some of which enacted more ethical policies than government itself. amazon and ebay swiftly banned secondhand sales of hand-sanitizer and bleach wipes, noting that such sales were in violation of policies related to fair pricing (terlep, ; tiffany, ) . ebay cited its 'disaster and tragedy' policy, which prohibits attempting 'to profit from human tragedy or suffering' (ebay, n.d.). meanwhile, there seems to be little political will to stop $ epipens at the governmental level. the prescriptive profit-seeking behavior incumbent to capitalism that is lauded in other times exists in tension with the cooperation required during crises. ambiguity around whether to applaud or punish profit-seeking behavior is demonstrated in the case of the student, whose 'dad was calling him up to let him know he's a "legend"' (harvey, ) . a commenter on the story wrote, 'give him ten years he'll be a great businessman who understands supply and demand'. in the same moment that people are dying from covid- , stores have shortages of hand-sanitizer because of pricegouging. the cognitive dissonance is clear and profitseeking wins plaudits even as it causes deaths. where this behavior is recognized as troubling, it is often reframed in terms of the behavior of a few 'bad apples', which shames individuals while concealing the economic structure incentivizing exactly that behavior-among individuals and businesses, including those making pharmaceuticals. it is this economic structure that puts all of us at risk. as one seller says 'i weighed whether or not this was a moral thing . . . my conclusion was, "if i don't do this, someone else is going to. that allowed me to do it"' (tiffany, ) . these stories are not amusing anecdotes about entrepreneurialism. they are about societal values, which the pandemic reveals are gendered and racialized matters of life and death in starker terms than usual. they are more evidence that health is a public good that is too important to be left to the market mechanism (segall, ) . going further, the stories are evidence that capitalism grows capitalists, from children to adults, who seek to profit from human suffering. the profit motive is at odds with the requirements of public health. capitalism incentivizes individual gain, while public health requires a slightly more complex understanding of individual and social needs over time. the profit motive undermines healthcare system capacity when, for example, 'entrepreneurs' hoard what are effectively inputs to health and healthcare. entrepreneurial hoarding means that some people cannot take precautions to maintain their health, which has the potential to increase the demand for healthcare. for healthcare workers the relationship is two-fold. when healthcare workers become sick because they do not have personal protective equipment, they increase demand for care while reducing supply of care. when healthcare workers die, this too reduces healthcare system capacity. the longer-term implications are dire. the profit motive and public health also present diametrically opposed normative interpretations of behavior. for individuals to behave 'well', in public health terms, is for them to not undermine the healthcare system, for example, by impeding healthcare workers' access to personal protective equipment. but to behave economically rationally, then, is to behave 'poorly'. individuals do have the right to behave imperfectly, even in solidaristic settings (davies and savulescu, ) , however, this particular variant of imperfect behavior keeps other individuals-healthcare workers and others-from being able to obtain commodities necessary for health. in effect, like (in)ability-to-pay on the demand side, the profit motive is a supply-side force that can render individuals incapable of responsibility for their health (levy, ) . if health is a public good (nonexcludable), as it arguably is, the ways markets misallocate provide a rationale for state responsibility. the state does not beat out the individual for ethical grounds to take responsibility for health, it beats the market. none declared. on the perils of invoking neoliberalism in public health critique against moral responsibilisation of health: prudential responsibility and health promotion the same lesson over and over: drugs alone will not get us to - - working paper solidarity and responsibility in health care disaster and tragedy policy. ebay student sent home for selling hand sanitizer by the squirt to classmates blaming the consumer: on the free choice of consumers and the decline in food quality in denmark taking responsibility for responsibility reflections on responsibility and the prospect of a long life the assets-based approach: furthering a neoliberal agenda or rediscovering the old public health? a critical examination of practitioner discourses unconditional welfare benefits and the principle of reciprocity an inquiry into the nature and causes of the wealth of nations amazon dogged by price gouging as coronavirus fears grow express scripts offers diabetes patients a $ cap for monthly insulin. the new york times the hand-sanitizer hawkers aren't sorry. the atlantic, march sharing responsibility: responsibility for health is not a zero-sum game patrick hoffman contributed initial thoughts and he and francois venter gave valuable feedback. key: cord- - br faov authors: xu, shuang-fei; lu, yi-han; zhang, tao; xiong, hai-yan; wang, wei-bing title: cross-sectional seroepidemiologic study of coronavirus disease (covid- ) among close contacts, children, and migrant workers in shanghai date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: br faov ( ) background: along with an increasing risk caused by migrant workers returning to the urban areas for the resumption of work and production and growing epidemiological evidence of possible transmission during the incubation period, a study of coronavirus disease (covid- ) is warranted among key populations to determine the serum antibody against the sars-cov- and the carrying status of sars-cov- to identify potential asymptomatic infection and to explore the risk factors. ( ) method: this is a cross-sectional seroepidemiologic study. three categories of targeted populations (close contacts, migrant workers who return to urban areas for work, and school children) will be included in this study as they are important for case identification in communities. a multi-stage sampling method will be employed to acquire an adequate sample size. assessments that include questionnaires and blood, nasopharyngeal specimens, and feces collection will be performed via home-visit survey. ( ) ethics and dissemination: the study was approved by the institute review board of school of public health, fudan university (irb# - - ). before data collection, written informed consent will be obtained from all participants. the manuscripts from this work will be submitted for publication in quality peer-reviewed journals and presented at national or international conferences. since the first known case of pneumonia infected with the novel coronavirus was reported in the city of wuhan in late december of , coronavirus disease (covid- ), caused by sars-cov- and announced by the world health organization on february , unexpectedly and quickly spread in china and many other countries with rapid geographical expansion and a sudden increase in the number of cases [ , ] . on january , covid- was added into china's "law on prevention and control of infectious diseases" as a class b notifiable disease and necessitated prevention and control measures as a class a because of its emergences [ ] . on january, the chinese government began to limit population movement in and out of wuhan. in the following week, provinces in mainland china successively launched response level i of the major public health emergency to respond to the covid- epidemic, including the lockdown of whole cities, cancelation of celebration activities of spring festival (chinese new year), and deferral of attendance at school and work. to our knowledge, the common clinical features of covid- are non-specific, such as fever, dry cough, and bilateral and peripheral ground-glass and consolidative pulmonary opacities on chest computed tomography (ct) scans, in addition to other symptoms including dyspnea, headache, muscle soreness, and fatigue [ , ] . according to the released data from the chinese center for disease control and prevention, the overall case-fatality rate (cfr) was . %, though the cfr was much higher among the critical ( %) and the elderly cases ( - %). of the total cumulative confirmed cases on february , , the majority ( %) were classified as non-pneumonia and mild pneumonia, and no death has been documented among those with mild or severe symptoms [ ] . at the end of february , a total of , confirmed covid- cases were recorded in mainland china, of whom , had been discharged and had died [ ] . thus far, the majority of published studies focused on hospitals and confirmed/suspected cases rather than on the population at risk in communities. along with the resumption of work and production activities and the adjustment of the emergency response level, an increasing number of migrant workers across the whole country are gradually returning to urban areas, which adds an extra burden on disease prevention and management. meanwhile, several studies provided epidemiological evidence of possible transmission of sars-cov- from pre-symptomatic and asymptomatic cases (asymptomatic people with sars-cov- detected in respiratory specimens or immunoglobulin m (igm) detected in serum) [ , ] . thus, a cross-sectional seroepidemiologic study of covid- among key populations is warranted to determine the potential risk of sars-cov- infection in different scenarios. the study introduces no significant risk to participants, with no medication or intervention involved. the study was approved by the institute review board of school of public health, fudan university (irb# - - ). before data collection, the purpose and procedures of the study will be explained to all the eligible participants. written informed consent will be obtained from all participants and from the parents of minors. participants can withdraw from the study at any point without any adverse consequences. all data are anonymous and will be managed confidentially. to determine the serum antibody level against the sars-cov- and the carrying status of sars-cov- among key susceptible populations to identify potential asymptomatic infection and to explore the risk factors. three categories of study participants will be recruited in the study as they are important for case finding in communities. participants must meet the following inclusion criteria: close contacts: the definition of "close contacts" is based on prevention and control of novel coronavirus pneumonia ( th edition), which refers to people who had unprotected close contact (within meter) with a confirmed or suspect case within two days before illness onset, or with an asymptomatic infected person within two days before sampling [ ] . in china, the tracing and management of close contacts is implemented by the local center for disease control and prevention (cdc), and all identified close contacts are recorded in health administration departments. • volunteer to participate in the survey and provide written informed consent. domestic migrant workers returning to urban areas for work: • aged years and above; • unconfirmed covid- cases; • volunteer to participate in the survey and provide signed informed consent. school children: • aged above years; • attending primary school, middle school, or high school (non-vocational high school); • unconfirmed covid- cases; • volunteer to participate in the survey and provide signed informed consent themselves and/or through their parent(s). • history of any neurologic disorders; • language disorders. this is a cross-sectional study design. the sample size is calculated according to the following formula: where nsrs is the sample size under simple random sample assumption; zα/ is the statistic corresponding to level of confidence, assumed to be . (when α = . ); d is precision, assumed to be %*p [ ] ; k is the missing rate, assumed to be % [ ] ; n is the minimum required sample size; p is the expected seroprevalence of antibodies against sars-cov- among the target populations. however, these parameters for the above three categories of study participants remain unclear. although the spread of sars-cov- is much faster than that of the sars-cov in , these two coronaviruses share a similar transmission mode, such as airborne transmission and close person-to-person contact, via respiratory droplets from sneezing or coughing, and fomites. thus, we consider referring to the transmission data of sars epidemic. in , after the sars epidemic, the seroprevalence of antibodies against sars-cov tested by enzyme-linked immunosorbent assay (elisa) among close contacts, general population and school children were . - . %, . - . % and - . %, respectively [ ] [ ] [ ] [ ] [ ] . similarly, we assume the expected seroprevalence of sars-cov- among close contacts, migrant workers, and school children to be %, %, and %, respectively. if the research designers in different regions obtain more specific local data, they can adjust the calculations. finally, in our design, the expected sample sizes for close contacts, migrant workers, and school children are , , and , respectively. multi-stage sampling methods will be employed to acquire adequate sample size. primary sampling units (psus) are sampled with a probability proportional to size (pps), that is, the number of subunits within each psu. given the different population sizes of the three categories of study participants and the different sampling strategies, the selected psus for each target population may not be identical. for close contacts, the specific sample size will be determined by the cumulative number of contacts in the city. it is best to include all contacts of the confirmed covid- cases, to maximize the statistical power of the study. otherwise, one-stage design with cluster sampling is chosen. here, "size" in pps refers to the number of close contacts in each district, which is now replaced by the size of confirmed covid- cases because there are no open data about close contacts in shanghai. the four districts, from the total , selected as psus with pps sampling were pudong district, xuhui district, yangpu district, and songjiang district ( table ) . all eligible close contacts in the selected districts will be enrolled. for migrant workers returning to the city for work, a two-stage design with pps and successive sampling is chosen. at the first stage, pps ("size" here refers to the floating population count in each district) sampling is employed to select four psus. considering the distribution of floating population in each district released by the shanghai statistics bureau in , pudong district, putuo district, baoshan district, and qingpu district were selected (table ) . at the second stage, a fixed number of individuals will be enrolled using successive sampling. for migrant workers, to our knowledge, migrants returning to shanghai are required to actively register with the village/neighborhood committees since january, . thus, all eligible migrant workers in each psu will be recruited one-by-one from the registers until the expected sample size is reached. for school children, a three-stage design with pps, simple random sampling (srs), and cluster sampling is chosen. at the first stage, pps ("size" here refers to the number of schools in each district at the second stage) sampling is employed to select psus. taking shanghai for example again, based on the data from shanghai education bureau [ ], pudong district, jing'an district, minhang district, and songjiang district were selected (table ) . at the second stage, schools in each district will be stratified as primary school, middle school, and high school, and srs will be used to select ~ schools from each stratum. at the third stage, or classes in each grade will be chosen at random, and all eligible students should be enrolled (the specific number of classes can be adjusted by the admission size). the sample size for school children is "deff" (the design effect in cluster sampling, assumed to be . ), which multiplies the expected value (n = ). sociodemographic characteristics: name, telephone (mobile) number, date of birth, sex, e-mail address, current address, ethnicity, job, educational level, parent employment status, educational level (only for children) and preferred mode of contact (telephone, email, or express delivery); . underlying conditions: pregnancy, obesity, cancer, diabetes, hypertension, heart disease, asthma requiring medication, chronic lung disease (non-asthma), chronic liver disease, chronic hematological disorder, chronic kidney disease, chronic neurological impairment/disease, and other underlying conditions. in addition, respiratory-pathogen-related vaccinations will be reviewed. clinical symptoms within the last days: body temperature, fever, chill, dry cough, sore throat, runny nose, shortness of breath, nausea, vomiting, diarrhea, and other symptoms. general exposure information: possible contact with confirmed/suspected cases, visits to medical facilities, and travel history (including destination, transfer, and duration) within the last days. appropriate personal protective equipment should be worn when specimens are being collected. specimens of close contacts will be collected by the designated local cdcs and medical facilities. specimens of migrant workers and school children will be collected by qualified technicians. all specimen containers should be labeled with the full name of the person being sampled, time and date of collection, and one other unique identifier such as the national medical insurance number. blood specimen: a ml whole-blood sample will be collected with a vacutainer with no anticoagulant. once the blood is drawn, the vacutainer should be inverted or times and placed at room temperature. when the blood specimen is sent to the laboratory, the vacutainer will be centrifuged for min at - rpm at room temperature. serum will be extracted by pipette and stored in a sterile spiral plastic tube. in addition, another ml whole-blood sample will be collected with a vacutainer containing edta anticoagulant. once the blood is drawn, the vacutainer should be inverted at least times and placed at room temperature for min. then the vacutainer will be centrifuged for min at - rpm at room temperature. plasma and blood cells will be separately collected into sterile spiral plastic tubes. • nasopharyngeal (np) swab: two np swabs will be collected for each eligible participant. the swab will be directly put in the nose parallel to the base of the np passage. the swab should move without resistance until reaching the nasopharynx, located about one-half to two-thirds the distance from the nostril to an ear lobe. if resistance occurs, the swab will be removed, and an attempt will be made to take the sample entering through the same or the other nostril. once the swab reaches nasopharynx, the swab will be rotated • , or left in place for s to saturate the swab tip; and then the swab will be removed slowly. then the swab head will be inserted into the tube containing . ml of virus preservation buffer (virus transport medium (containing hank's balanced salt solution, polymyxin b, vancomycin, bovine serum albumin, cryoprotectant, biobuffer, etc.), shanghai comagal microbial technology co. ltd.) and swab shaft will be evenly broken at the scored line to fit in tube and replace cap tightly. feces or anal swab: - ml of stool that has not been mixed with urine will be collected in a clean, dry, leak-proof container. if it is not convenient to collect fecal samples, an anal swab can be collected. the disinfectant cotton swab will be gently inserted into the anus to a depth of - cm, then it will be gently rotated pulled out, and immediately put into a ml screw-capped sampling tube containing - ml virus preservation buffer. then, the swab shaft will be evenly broken at the scored line to fit in tube and the cap will be replaced tightly. blood specimens, np swabs, and anal swabs should be taken at the home visit. feces could be collected the next day. all specimens will be shipped to the laboratory in a sealed biohazard bag within h after collection at • c on ice packs. if transportation will be delayed more than h, specimens should be reserved at − • c and shipped on dry ice. it is important to avoid repeated freezing and thawing of specimens. laboratory examinations • serological testing: the serum specimen will be available for qualitative detection of sars-cov- -specific total antibodies (including igm, igg, iga, and other antibody types) with novel coronavirus ( -ncov) antibody test kit (chemiluminescence immunoassay method) (registered number: ), developed by xiamen innodx biotech co., ltd. (xiamen, china) and which is the world's first approved total antibody detection reagent with the double-antigen sandwich method for sars-cov- . it can rapidly and simply detect specific antibodies within min. • etiological testing: a real-time fluorescence-based reverse transcriptase-polymerase chain reaction (rt-pcr) assay will be applied to the np specimen and feces to detect sars-cov- . the primers and probes (targeting open reading frame ab (orf ab) and nucleocapsid protein (n) in the novel coronavirus genome) used for sars-cov- detection by rt-pcr is from the novel coronavirus pneumonia: laboratory testing guideline, released by national health commission of the prc. in addition, np specimens will be further examined for a total of respiratory pathogens (table ) via gene chips (micro-fluid chip for respiratory pathogens, product number: ). in this cross-sectional survey, participants with serological evidence (sars-cov- -specific igm and igg detectable in serum) or etiological evidence (real-time fluorescent rt-pcr indicating positive for sars-cov- nucleic acid) will be diagnosed as confirmed cases. the study design is presented in figure . investigators will communicate with the selected participants or guardians in advance to assure their intention of participating this program. the refusers will be replaced by resampling without replacement in each psu. investigators will visit the eligible participants at the appointed time; obtain written informed consent; complete the questionnaire survey; and collect blood specimens, np swabs, and annal swabs. feces specimens are limited to diarrheal participants and will be self-collected with sterile containers. investigators will take them in the next day. during the investigation, investigators will inform the participants of laboratory results via their preferred mode of contact, such as telephone, email, or express delivery. the identified asymptomatic cases in the survey will immediately report to local cdcs and transfer to medical facilities. the primary benefit of the investigation is to prevent the further spread of the virus. on completion of the investigation, data will be imported into the data analysis software (spss version . and sas version . ) for data cleaning and statistical analysis. the prevalences of sars-cov- -specific antibodies in serum and those of sars-cov- , and other respiratory pathogens in np specimens will be presented with their % confidence intervals (cis). participants' characteristics will be described as means ± sds for normally distributed variables, as medians, and interquartile ranges (iqrs) for non-normally distributed variables, and as frequencies and proportions for categorical variables. bivariate and multivariable analyses will be performed to identify potential factors associated with infection of sars-cov- and other respiratory pathogens among study participants. differences between groups will be compared with independent-samples t tests or mann-whitney u tests (for continuous variables), χ tests or fisher's exact tests (for categorical variables), and analysis of variance or kruskal-wallis where applicable. appropriate statistical models (logistic regression models and generalized linear mixed models) will be performed to estimate the odds ratios (ors) of factors associated with sars-cov- infection. adjusted odds ratios (aors) will be obtained using a multivariable model, including the following covariates: age, gender, occupation, education. further analysis will be determined upon more discussion. a p-value < . will be considered statistically significant. on completion of the investigation, data will be imported into the data analysis software (spss version . and sas version . ) for data cleaning and statistical analysis. the prevalences of sars-cov- -specific antibodies in serum and those of sars-cov- , and other respiratory pathogens in np specimens will be presented with their % confidence intervals (cis). participants' characteristics will be described as means ± sds for normally distributed variables, as medians, and interquartile ranges (iqrs) for non-normally distributed variables, and as frequencies and proportions for categorical variables. bivariate and multivariable analyses will be performed to identify potential factors associated with infection of sars-cov- and other respiratory pathogens among study participants. differences between groups will be compared with independent-samples t tests or mann-whitney u tests (for continuous variables), χ tests or fisher's exact tests (for categorical variables), and analysis of variance or kruskal-wallis where applicable. appropriate statistical models (logistic regression models and generalized linear mixed models) will be performed to estimate the odds ratios (ors) of factors associated with sars-cov- infection. adjusted odds ratios novel coronavirus ( -ncov): situation report, . ; world health organization early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia national health commission of the people 's republic of china. announcement by the national health commission relationship to duration of infection updated understanding of the outbreak of novel coronavirus ( -ncov) in wuhan the novel coronavirus pneumonia emergency response epidemiology team. the epidemiological characteristics of an outbreak of novel coronavirus diseases (covid- )-china, . china cdc wkly national health commission of the people's republic of china. the latest status of -novel-coronavirus ( -ncov) pneumonia at o' clock clinical characteristics of asymptomatic infections with covid- screened among close contacts in nanjing a familial cluster of infection associated with the novel coronavirus indicating possible person-to-person transmission during the incubation period national health commission of the people' s republic of china. protocol on prevention and control of novel coronavirus pneumonia sars-cov antibody prevalence in all hong kong patient contacts seroprevalence of igg antibodies to sars-coronavirus in asymptomatic or subclinical population groups severe acute respiratory syndrome among children epidemiological research on sars coronavirus antibody in serum among healthy population of qingyuan city seroepidemiological study on severe respiratory syndrome among different population in taiyuan the authors declare no conflict of interest. key: cord- -tqh wv authors: ijaz, m. khalid; sattar, syed a.; rubino, joseph r.; nims, raymond w.; gerba, charles p. title: combating sars-cov- : leveraging microbicidal experiences with other emerging/re-emerging viruses date: - - journal: peerj doi: . /peerj. sha: doc_id: cord_uid: tqh wv the emergence of severe acute respiratory syndrome coronavirus (sars-cov- ) in wuhan city, china, late in december is an example of an emerging zoonotic virus that threatens public health and international travel and commerce. when such a virus emerges, there is often insufficient specific information available on mechanisms of virus dissemination from animal-to-human or from person-to-person, on the level or route of infection transmissibility or of viral release in body secretions/excretions, and on the survival of virus in aerosols or on surfaces. the effectiveness of available virucidal agents and hygiene practices as interventions for disrupting the spread of infection and the associated diseases may not be clear for the emerging virus. in the present review, we suggest that approaches for infection prevention and control (ipac) for sars-cov- and future emerging/re-emerging viruses can be invoked based on pre-existing data on microbicidal and hygiene effectiveness for related and unrelated enveloped viruses. late in december , cases of pneumonia began appearing in wuhan city, hubei province, china. by early january , these cases were attributed to a novel coronavirus that was temporarily referred to as novel coronavirus ( -ncov) (world health organization, a) . this member of the coronaviridae family was subsequently named severe acute respiratory syndrome coronavirus (sars-cov- ) (gorbalenya et al., ) . as of august , (world health organization, c , there have been over , , confirmed cases globally, with , deaths (case mortality rate of . %). this emerging virus, and the associated disease , have not only impacted public health, but also international commerce and travel. as with the middle east respiratory syndrome coronavirus (mers-cov) that emerged in saudi arabia in and the severe acute respiratory syndrome coronavirus (sars-cov) that emerged in china in early , sars-cov- is considered a zoonosis, with bats suspected as the primary host species (table ) . the coronaviridae is just one of several families of enveloped viruses that have emerged/re-emerged in recent years (table ) (zhan et al., ; ang, lim & wang, ; brocato & hooper, ; laenen et al., ; viral hemorrhagic fever consortium, ) . while the list of viruses in table is not intended to be comprehensive, it contains most of the virus families attributed to the world health organization (who) current list of disease priorities needing urgent r&d attention (world health organization, ) (i.e., mers and sars (coronaviridae), crimean congo hemorrhagic fever (nairoviridae), rift valley fever (phenuiviridae), ebola virus disease and marburg virus disease (filoviridae), nipah and hendra virus disease (paramyxoviridae), and lassa fever (arenaviridae)). to our knowledge, no one has systematically compared the characteristics of the viruses causing the diseases in the who current list of disease priorities needing urgent r&d attention (world health organization, ) . there may be common characteristics that may favor sustained transmissibility or mortality and could inform infection prevention and control (ipac) activities. this review is intended to aid the ipac community in arriving at strategies for dealing with sars-cov- , as well as future emerging/re-emerging viruses, by evaluating relevant characteristics of these viruses of concern. in particular, it is our hope that this information may be leveraged to effectively mitigate the health risks ( ) notes: * segments ( ) equates to a non-segmented genome. † now referred to as huaiyangshan banyangvirus. ‡ suspected primary host based on > % sequence homology to bat coronaviruses (zhou et al., ) . ±, ambisense; −, negative sense; +, positive sense; ss, single-stranded. associated with sars-cov- and its associated disease , as well as with future emerging/re-emerging enveloped viruses. the emerging/re-emerging viruses shown in table , with the exception of enterovirus d (ev-d ), each are relatively large, enveloped, zoonotic viruses with single-stranded rna genomes. ev-d , a small non-enveloped virus of the picornaviridae family, is an example of a re-emerging virus from that family. while ev-d may also be zoonotic (bailey et al., ; fieldhouse et al., ) , a reservoir species has yet to be identified for that virus. aside from the characteristics described in table , what other commonalities exist for these emerging/re-emerging zoonotic viruses? can we use these commonalities as the basis for proposing approaches for ipac? in the remainder of this review, we examine various aspects of the emerging/re-emerging viruses that may be important in formulating approaches for ipac, namely transmissibility, infectivity, viral shedding, environmental survival, and expectations regarding microbicidal efficacy for targeted hygiene practices. our hypothesis is that, when dealing with emerging enveloped viruses, knowledge of the susceptibility of one enveloped virus to microbicides which disrupt the lipid envelope should enable one to predict which microbicides should prove efficacious for other enveloped viruses, including emerging/re-emerging viruses. this literature review focused upon the who list of diseases of concern (world health organization, ) and our search of the literature pertaining to the various virus notes: "contact" refers to contact with bodily fluids or with fomites; "aerosols/droplets" equates to respiratory aerosols/large or small droplets. cns, central nervous system; gi, gastrointestinal. characteristics considered in tables - . as such, the pubmed and google scholar search terms included the virus names themselves as well as terms encompassing the topics addressed in the tables. these therefore included coronaviruses, lassa virus, sftsv, hantaan virus, mers-cov, sars-cov, sars-cov- , ebola virus, influenza h n , nipah virus, ev-d , particle size, reservoir species, tissue tropism, mode of transmission, transmissibility, virus shedding, minimal infectious dose, infectious dose , mortality, survival on surfaces, persistence on surfaces, stability on surfaces, survival in aerosols, persistence in aerosols, stability in aerosols, microbicidal efficacy, virucidal efficacy, disinfectant efficacy, antiseptic efficacy, emerging/re-emerging enveloped viruses, uvc susceptibility, zoonoses, and personal hygiene for sars-cov- . active search of the literature concluded as of july , . no exclusion criteria were used. this was not intended to represent a comprehensive review of the literature addressing all of the topics covered. rather, it represents a compilation, by the authors, of the salient information regarding the set of emerging/re-emerging viruses under evaluation that, hopefully, will enable the reader to consider possible commonalities that inform ipac. our bias was toward information on the viruses causing the who diseases of concern and sars-cov- , especially, in order to render the review of most potential utility and interest to the ipac community. this, necessarily, resulted in our paying greatest attention to articles primarily from the past years and to research and review articles pertaining to sars-cov- topics. sattar et al. ( ) notes: * aerosol data for human coronavirus e (ijaz et al., ) . survival half-life depended on humidity and temperature. the values ranged from . h (~ % rh), h ( % rh), to h ( % rh). † no data for sftsv are available; the result displayed is for crimean-congo virus. ‡ no data for ev-d are available; the result displayed is for human rhinovirus type at - % rh (sattar et al., ) . ¶ the authors only evaluated times up to h (van doremalen et al., ). according to several authors (geoghegan et al., ; walker et al., ; munster et al., ) , sustained person-to-person transmission of viruses is favored by certain viral characteristics, including lack of a lipid envelope, small particle size, limited genomic segmentation, and low mortality of the associated disease. tropism of the virus for the liver, central nervous system (cns), or the respiratory tract, and lack of vector-borne transmission also appear to favor sustained person-to-person transmission (geoghegan et al., ; walker et al., ) . on the other hand, possession of an rna vs. a dna genome was not found to contribute to the likelihood of such sustained transmission (geoghegan et al., ; walker et al., ) . it is of interest that many of the viral characteristics mentioned above that are considered predictive of sustained person-to-person transmissibility are not shared by the viruses associated with the who diseases of concern. namely, all of the emerging/ re-emerging diseases mentioned in the who list (world health organization, ) involve relatively large enveloped viruses with ssrna genomes, many of which are segmented. of the emerging/re-emerging viruses listed in table , only ev-d is a small, non-enveloped virus. in addition, many of the who viruses of concern exhibit relatively high human mortality (tables and ). it should be noted that the mortality values found in the literature for these emerging/re-emerging viruses represent case mortality rates (i.e., number of deaths per number of confirmed cases), not true mortality rates (i.e., number of deaths per number of infected persons). true mortality rates for these viruses are not known, though are likely to be lower than the case mortality rates displayed, as all asymptomatic cases are not included in the case mortality calculation. certain predictive factors (geoghegan et al., ; walker et al., ; munster et al., ) that do seem to be shared by the emerging/re-emerging viruses in the list in table include tropism for the respiratory tract or the cns, and lack of vector-borne transmission. while most enteroviruses are less susceptible to acid and are disseminated by the fecal-oral route, ev-d is acid-labile and has a lower temperature optimum, reflecting its tropism for the upper respiratory tract rather than the gastrointestinal tract (i.e., ev-d acts more like a rhinovirus than an enterovirus) (sun, hu & yu, ) . it is unknown if sustained person-to-person transmissibility necessarily equates to a high level of concern for an emergent zoonotic virus. for instance, there appears to be no evidence that hendra virus (another zoonotic enveloped virus) has shown person-toperson transmission (paterson et al., ) , yet this virus is similar to nipah virus in many respects and is of concern, due its high case mortality rate in humans. as mentioned in table , the most common modes of transmission for the emerging/ re-emerging viruses discussed in this review are contact with infected bodily secretions/ excretions and contaminated fomites, especially high-touch environmental surfaces (hites), and inhalation of respiratory droplets/aerosols containing infectious virus (fig. ) . the intermediacy of hands in transmission through contact is emphasized in fig. . the animal-to-human and person-to-person transmission of sars-cov- and associated covid- disease appears to occur in a manner similar to that described for mers-cov and sars-cov. that is, the transmission of sars-cov- ( fig. ) primarily involves direct inhalation of large respiratory droplets or inhalation of small airborne droplets (morawska et al., ; patel et al., ; world health organization, d) leading predominantly to respiratory tract infections. secondary (indirect) transmission of sars-cov- may also occur through contamination of hites by droplets and respiratory aerosols or other patient's bodily fluids (bronchoalveolar fluid, sputum, mucus, blood, lacrimal fluid, semen, urine, or feces) (morawska et al., ; patel et al., ; world health organization, d; wang et al., ) . evidence of the role for the latter transmission pathway comes from experimental transmission studies in animal models (sia et al., ) and by the results of investigations on the contamination of hites with sars-cov- rna in healthcare settings (jiang et al., ; ong et al., ; patel et al., ; ye et al., ) . the infectivity of a virus refers to its ability to initiate infection of a host cell with production of viral progeny. the infectious dose (id ) is the smallest number of infectious virus particles that will lead to infection of % of an exposed population (westwood & sattar, ) , and is dependent on a number of factors, such as the species, age, or race of the host, the receptor, immune and nutritional status of the host or host tissues, and the portal of entry of the virus. in the case of most viruses, only a percentage of . ipac may be difficult in the face of such silent disseminators (virus carriers/ shedders). exposure to as low as one infectious viral particle has a probability of causing an infection leading to disease, although that probability varies from virus to virus (yezli & otter, ) . typically, infectious doses are empirically derived and reported in units of % infective dose (id ) values that reflect the doses capable of infecting half of the subjects exposed. as prospective studies in humans of highly pathogenic viruses with potentially fatal outcomes (such as sars-cov- ) cannot ethically be performed, very limited data exist on the infectivity of the emerging/re-emerging viruses in table . where studies have been performed using animals, extrapolations of such data to humans must be made with caution. the estimates that have been reported for viruses listed in tables and are discussed below, acknowledging the unavoidable variability in literature with regard to such assessments of infectivity. it has been stated that - infectious aerosolized ebola virus particles can cause an infection in humans (franz et al., ; bibby et al., ) . a similar range has been reported for lassa virus (cieslak et al., ) . influenza virus infectivity values specific to the h n and h n strains are not available, but estimates of to , infectious viral particles have been reported (yezli & otter, ; cieslak et al., ) . the human infective dose for sars-cov has been estimated at - plaque-forming units (watanabe et al., ) . data on the human infectious doses for mers-cov, severe fever with thrombocytopenia syndrome virus (sftsv), nipah virus, ev-d , and sars-cov- have not been reported. until such data become available, it should be assumed that these emerging/re-emerging viruses, including sars-cov- , have relatively low id values. once infected with one of these emerging/re-emerging viruses, during the prodromal period before actual appearance of symptoms, as well as once symptoms appear, the infected individual may become a shedder of infectious particles, as mentioned above. the extent to which virus shedding might lead to dissemination of the associated disease depends upon a number of factors, including the amount of virus released (shed), the infectivity of the virus within the released matrix (droplets/aerosols, fecal/diarrheal discharge, and other excretions, including respiratory secretions), and the survival of the released viruses within such matrices once dried on hites. extent of virus shedding, unfortunately, is commonly measured through detection of genomic material (e.g., otter et al., ; yezli & otter, ; hassan et al., ; killerby et al., ; santarpia et al., a santarpia et al., , b , rather than through use of cell-based infectivity assays, so there are only limited data available on infectious sars-cov- viral shedding (francis et al., ; widders, broom & broom, ; santarpia et al., a santarpia et al., , b . as displayed in fig. , transmission of respiratory infections commonly involves the intermediacy of the hand. the same can be said about gastrointestinal infections (i.e., through the fecal-oral route). the coronaviruses sars-cov, mers-cov, and sars-cov- have been reported (otter et al., ; zhang et al., ) to be shed from patients both within respiratory and gastrointestinal secretions/excretions, therefore contaminated hites and large and small respiratory droplets/aerosols may potentially play an important role in dissemination of sars-cov- (morawska et al., ) , in many cases through the intermediacy of hands (guo et al., ). knowledge of the transmissibility and infectivity of emerging/re-emerging viruses enables one to assess the risk of spread of a viral disease in the case that infectious virus is shed from an infected individual and is deposited on environmental surfaces/fomites or in droplets/aerosols. another important factor to consider when assessing risk is the survival (i.e., the continued infectivity) of these viruses on the environmental surfaces/fomites or in air in the form of droplets/aerosols. there is much more information addressing survival of infectious viruses on environmental surfaces than in aerosols. the data that are available address a number of environmental factors of relevance (otter et al., ) , including the types and porosities of the surfaces, the matrices in which the viruses have been suspended prior to being deposited onto the surfaces, the temperature and relative humidity (rh), and methods used for measuring survival (e.g., log reduction in infectivity per unit time, infectivity half-life, infectious titer after a measured duration, etc.). for table , the results that have been displayed focus on room temperature (ambient) conditions at relatively low and medium rh. table should not, therefore, be considered to represent a comprehensive review of literature for survival of these viruses on surfaces. table . sars-cov- was found to remain infectious in aerosols for at least the -h period studied by van doremalen et al. ( ) . the survival half-life estimated based on the limited period of observation of that study was min. in experiments conducted with hcov- e over a -day observation period, the survival half-life was found to depend on rh and temperature (ijaz et al., ) . at c, the half-life values observed were . h (~ % rh), h ( % rh), and h ( % rh). a different pattern of results was obtained at low temperature ( c) and high rh (~ ~), with the half-life increasing to h, nearly times that found at c and high rh. the pronounced stabilizing effect of low temperature on the survival of hcov- e at high rh indicates that the role of the environment on the survival of coronaviruses in air may be more complex and significant than previously thought (ijaz et al., ) . this likely is the case for sars-cov- as well. the survival of sars-cov- on prototypic hites has been investigated, and survival of the virus has been reported for up to h on cardboard and - days on plastic and stainless steel surfaces. survival in the presence of an organic load was generally longer than survival in the absence of such a load (chin et al., ; van doremalen et al., ; kasloff et al., ; pastorino et al., ; harbourt et al., ) . infectious virus surviving in aerosols/droplets or on hites represents a source for dissemination of emerging/re-emerging viruses, including sars-cov- . the enveloped viruses listed in tables and should be relatively susceptible to the virucidal activity of a variety of microbicides, as discussed below. sattar ( ) previously has advanced the concept of utilizing the known knowledge of the susceptibility of human viral pathogens to chemical disinfecting agents (microbicides) (klein & deforest, ; mcdonnell & russell, ; ijaz & rubino, ) , to predict the efficacy of such agents for inactivating emerging/re-emerging viral pathogens. this concept, referred to as a hierarchy of susceptibility to microbicides, is portrayed in fig. . as shown, infectious agents can be viewed as displaying a continuum of susceptibilities to microbicides, with enveloped viruses at the bottom of this hierarchy, highlighting their relatively high susceptibilities to formulated microbicides (klein & deforest, ; mcdonnell & russell, ; sattar, ; ijaz & rubino, ) . among pathogens, prions are considered to be the least sensitive to microbicides, requiring highly caustic solutions for inactivation. bacterial spores and protozoan cysts/ oocysts are next on the microbicidal susceptibility spectrum. small, non-enveloped viruses are considered to be less susceptible to microbicides, although these viruses display increased susceptibility to high ph, oxidizers such as sodium hypochlorite, activated hydrogen peroxide, alcohols, and a variety of microbicidal actives, relative to spores and protozoan cysts/oocysts. mycobacteria, fungi, vegetative bacteria, and enveloped viruses appear to be more susceptible to certain formulated microbicides, such as alcohols, oxidizers, quaternary ammonium compounds (qac), and phenolics (e.g., p-chloro-mxylenol (pcmx)) (klein & deforest, ; sattar et al., ; mcdonnell & russell, ; rabenau et al., ; sattar, ; ijaz & rubino, ; geller, varbanov & duval, ; maillard, sattar & pinto, ; cook et al., cook et al., , cutts et al., cutts et al., , cutts et al., , rutala et al., ; weber et al., ; chin et al., ; kampf et al., ; o'donnell et al., ; senghore et al., ; vaughan et al., ; yu et al., ) . a number of commercially available formulated microbicides (antiseptic liquid, hand sanitizers, liquid hand wash, bar soap, surface cleanser, disinfectant wipe, and disinfectant spray) have been evaluated for virucidal efficacy against sars-cov- (ijaz et al., ) , and as expected, were found to cause complete inactivation ( . - . log ) within the - min contact times tested. it is of interest that the enveloped viruses are considered to be the most susceptible to a variety of formulated microbicidal actives, even more so than fungi and vegetative bacteria, yeast, and mycobacteria (fig. ) . viral envelopes are typically derived from the host cell and are, therefore, comprised of host cell phospholipids and proteins (fig. ) , as well as some virally inserted glycoproteins. coronaviruses are known to obtain their lipid envelopes from the host cell endoplasmic reticulum golgi intermediate compartment, after which the particles are transported by exocytosis via cargo vesicles (reviewed in o'donnell et al. ( ) ). the composition of the coronavirus lipid envelope, therefore, is determined by the lipid composition of the host cell endoplasmic reticulum. since the envelopes contain lipid material, they are readily destroyed by phenolics such as pcmx, oxidizing agents such as sodium hypochlorite and activated hydrogen peroxide, qac, alcohols, and detergents. even mild detergents, such as soap, may inactivate enveloped viruses by denaturing the lipoproteins in the envelope. these include the sars-cov- spike proteins that interact with the human angiotensin-converting enzyme receptor as a requisite event in initiating viral infection (letko, marzi & munster, ) . this makes enveloped viruses more susceptible to most of the formulated virucidal microbicides commonly used for ipac. it can be assumed as a starting point, therefore, that the enveloped emerging/reemerging viruses listed in table should be readily inactivated by a variety of formulated microbicidal actives. this assumption has, in fact, been verified by extensive empirical data (klein & deforest, ; sattar et al., ; mcdonnell & russell, ; rabenau et al., ; sattar, ; ijaz & rubino, ; geller, varbanov & duval, ; cook et al., cook et al., , cutts et al., cutts et al., , cutts et al., , weber et al., ; chin et al., ; ijaz et al., ; kampf et al., ; o'donnell et al., ; vaughan et al., ; yu et al., ; castaño et al., ) , and has been embraced by the u.s. environmental protection agency (united states environmental protection agency, ). the data for various members of the coronaviridae family, reviewed recently by kampf et al. ( ) , cimolai ( ), and golin, choi & ghahary ( ) support the expectation that sars-cov- and other coronaviruses of concern (e.g., mers-cov, sars-cov, mouse hepatitis virus, porcine epidemic diarrhea virus, etc.) should be readily inactivated by commonly employed and commercially available formulated microbicides, including qac. virucidal efficacy testing results for sars-cov- reported by ijaz et al. ( ) also confirm the expectation of susceptibility of this coronavirus to a variety of microbicidal actives. in addition, a recently issued european guidance document (european centre for disease prevention & control, ) lists a variety of microbicidal agents that have demonstrated efficacy against a variety of human and animal coronaviruses and that, therefore, could be applied for decontamination of surfaces in non-healthcare facilities. aqueous solutions of the phenolic pcmx at concentrations of . - . % by weight were shown to inactivate > log of infectious ebola virus-makona variant (ebov/mak) suspended in an organic load and evaluated in liquid virucidal efficacy studies (cutts et al., ; or dried on a steel surface (a prototypic hites) in a hard surface carrier viricidal efficacy study (cutts et al., ) . in each case, complete inactivation of ≥ . log of ebov/mak was observed after contact times ≥ min. in addition, ebov/mak dried on prototypic steel carriers was completely inactivated (≥ . log ) by aqueous solutions of % ethanol or . % or % naocl (≥ . %) after contact times ≥ . min (cook et al., ) . disinfectant pre-soaked wipes containing, as active ingredients, either activated hydrogen peroxide or a qac were found to have virucidal efficacy (> log ) for ebov/mak and vesicular stomatitis virus following as little as s contact time (cutts et al., ) . microbicidal formulations based on oxidizing agents, qac, alcohols, phenolics, and aldehydes displaying virucidal efficacy for enveloped viruses and relatively less susceptible non-enveloped viruses (such as human norovirus surrogates) have been recommended for decontaminating environmental surfaces or materials used for food preparation (zonta et al., ; scott, bruning & ijaz, ) . the efficacy of ethanol and qac actives for inactivating the norovirus surrogate feline calicivirus depends on how the microbicides are formulated. factors, such as the addition of an alkaline agent, were found to increase their efficacy (whitehead & mccue, ) . microbicides satisfying these requirements can be regarded as effective against emerging/re-emerging viruses, such as sars-cov- . following this logic, the u.s. epa has invoked an emerging viral pathogen policy in the past for pandemic influenza, for the ebola virus, and most recently, for sars-cov- (united states environmental protection agency, ). in the case of highly pathogenic emerging/re-emerging viruses, such as sars-cov- , effective and frequent targeted hygiene using appropriate microbicides is essential for prevention of infectious virus dissemination. practicing hygiene inappropriately and only once daily may not be sufficient, as recontamination of hites could potentially occur, particularly under healthcare settings where sars-cov- infected patients are treated. for instance, infectious coronavirus e was detected on hites (e.g., door knobs) in a university classroom in which samples were collected daily over a -week period (bonny, yezli & lednicky, ) . vigilant decontamination of hites becomes of paramount importance in high risk areas, such as intensive care units (zhang, ) . this is especially true when dealing with highly pathogenic viruses with relatively low human infectious doses, as is the case with many of the emerging/re-emerging viruses, and likely including sars-cov- , being discussed in this review. the enveloped emerging/re-emerging viruses listed in table display high susceptibility to inactivation by ultraviolet light at nm, an inactivation approach amenable to inactivation of aerosolized viruses (ijaz et al., ) . for instance, empirical data (lytle & sagripanti, ) for lassa virus, hantavirus, and ebola virus, and for the virus families coronaviridae, orthomxyoviridae, paramyxoviridae, phenuiviridae, indicate that uv fluencies of - mj/cm should inactivate log of the enveloped viruses in table . the susceptibility of coronaviruses, including hcov- e, sars-cov, and mers-cov, to uv irradiation has been reviewed recently (heßling et al., ) . characterization of the uv-c susceptibility of sars-cov- has also been evaluated (bianco et al., ) . in that study, a fluency of . mj/cm resulted in log inactivation. these fluency values are relatively low, compared to those needed to inactivate log of the least uv-susceptible viruses, such as those of the adenoviridae ( - mj/cm ) and polyomaviridae ( - mj/cm ) families of non-enveloped viruses (nims & plavsic, ) . the who has posted a webpage entitled "coronavirus disease (covid- ) advice for the public" (world health organization, b). basic protective measures against sars-cov- recommended by the who include: frequent hand washing with soap and water or an alcohol-based rub and maintenance of social distancing (at least m; see fig. ), especially in the presence of people who are coughing, sneezing, or have a fever (world health organization, b) . the latter recommendation is applicable to any of the viruses listed in table , for which transmission by respiratory aerosols/droplets is expected. avoidance of touching eyes, nose, mouth, or other mucous membranes with hands after contact with hites is also recommended (world health organization, b). as displayed in fig. , the hands play an important role in transfer of infectious virus from contaminated hites to a susceptible mucous membrane, enabling virus-host interactions initiating infection. following the appropriate hygiene practices described above can potentially help in prevention and control of emerging and re-emerging viruses, including the currently circulating sars-cov- . the u.s. cdc has posted a webpage entitled "coronavirus (covid- ) how to protect yourself and others" (united states centers for disease control & prevention, ). this includes a brief description of the primary modes of transmission of the virus, advice on handwashing (especially situations after which hand washing should be done), advice on social distancing, admonitions on use of face coverings, targeted hygiene of frequently touched surfaces (hites), and self-monitoring of health. while handwashing practices practically can be applied in developed countries, there are still some three billion people in developing countries without access to basic handwashing facilities in the home and where proper hand hygiene may not be practiced in the majority of healthcare facilities (mushi & shao, ) . basic ipac practices, such as those mentioned by the who and by the u.s. cdc, are applicable not only to the current sars-cov- pandemic, but also to any emerging outbreaks involving enveloped viruses, which are highly susceptible to hand washing using soap and water and alcohol-based hand rubs and to surface hygiene using commonly employed household disinfectants. as dr. anthony fauci eloquently stated in (fauci, , "public health officials once suggested that it might someday be possible to 'close the book' on the study and treatment of infectious diseases. however, it is now clear that endemic diseases as well as newly emerging ones (e.g., west nile virus), and even deliberately disseminated infectious diseases (e.g., anthrax from bioterrorism) continue to pose a substantial threat throughout the world." recent experience certainly verifies these predictions. weber et al. ( ) have correctly emphasized that "preventing disease acquisition via person-to-person transmission or contact with the contaminated environment depends on rapid and appropriate institution of isolation precautions, appropriate hand hygiene, and appropriate disinfection of medical equipment, devices, and the surface environment. importantly, once the nature of the emerging disease is known (i.e., enveloped virus, bacteria, fungi, nonenveloped virus, mycobacteria), it is possible to determine the proper antiseptics and disinfectants, even in the absence of studies of the exact infectious agent. for example, an enveloped virus (e.g., ebola, mers-cov) or vegetative bacterium (e.g., cre) would be inactivated by any agent against nonenveloped viruses or mycobacteria." . it is fortunate that so many of the emerging/re-emerging viruses (examples listed in table and below) are enveloped viruses. it is not clear why there are not more small, non-enveloped viruses mentioned in the who list of viral diseases of concern (world health organization, ). the small non-enveloped viruses are much less susceptible to commonly employed cleaning agents (antiseptics, detergents, microbicidal actives) and, in general, display relatively longer survival on environmental surfaces. according to theoretical modeling of sustained person-to-person transmissibility (geoghegan et al., ; walker et al., ; munster et al., ) , small non-enveloped viruses are predicted to be more likely to lead to sustained infections within the community. the reality is that the emerging/re-emerging viruses of concern, both in humans and in economically important animals, have more typically included enveloped viruses. recent examples include porcine epidemic diarrhea virus, mers-cov, sars-cov and sars-cov- (coronaviridae), african swine fever virus (asfarviridae), schmallenberg virus (peribunyaviridae), crimean-congo hemorrhagic fever virus (nairoviridae), rift valley fever virus (phenuiviridae), west nile virus and zika virus (flaviviridae), hantaviruses (hantaviridae), and lassa viruses (arenaviridae). the fact that the emerging/re-emerging viruses are predominantly rna viruses might be explained in part by the notion (jaijyan et al., ) that rna viruses can more readily adapt to the rapidly changing global and local environment due to the high error rate of the polymerases that replicate their genomes. the rna viruses are thought, therefore, to display higher evolution rates through mutation, genomic reassortment, or recombination. in our review of articles pertaining to sars-cov- ipac, we have identified several knowledge gaps. these include the fact that contamination of surfaces in the vicinity of covid- patients (i.e., contamination hot-spots) has primarily been described on the basis of measurement of sars-cov- rna, and not on the basis of recovery of infectious virus using cell-based assays. the measurement of rna does not inform as to the infection potential of the surface contamination. similarly, articles describing the contamination of waste-water streams by sars-cov- have been based on measurement of viral rna, not infectious virus. as a result, it is not presently known whether infectious virus is present in such waste streams and, therefore, whether the finding of viral rna in waste water represents real risk in terms of onward dissemination of the virus. another knowledge gap, that has already been mentioned above, is the true mortality rates for the various emerging/re-emerging viruses addressed in this review. as these viral infections are relatively deadly, empirical data on true mortality rates are lacking. for the same reason, accurate data on human mid are not generally available for these viruses. the risk of acquiring an infection of one of these viruses from a contaminated environmental surface, over a period of time following an initial contamination event, will remain difficult to assess until such knowledge gaps have been resolved. the likelihood of experiencing future emergent zoonotic viruses is high (morens & fauci, ; paules, marston & fauci, ) , and defining in advance appropriate approaches for limiting the spread of such viruses through ipac is essential. we now have the sequencing tools necessary for rapidly identifying a novel virus such as sars-cov- , the genetic sequence of which was determined within just over week . provided that a novel emerging virus is found to be a member of a lipid-enveloped viral family, it should be possible to leverage ipac experience for other enveloped viruses of concern, and thereby make predictions as to risk of viral transmission, virus survival on surfaces, and microbicidal efficacy for the virus and risk mitigation. sars-cov- is no exception in this regard. joseph r. rubino analyzed the data, authored or reviewed drafts of the paper, and approved the final draft. raymond w. nims conceived the review approach, review, analyzed the data, prepared figures and/or tables, 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surrogate for norovirus, in a short contact time sars-cov- : the viral shedding vs. infectivity dilemma environmental persistence of a highly pathogenic avian influenza (h n ) virus who publishes list of top emerging diseases likely to cause major epidemics world health organization. a. novel coronavirus ( -ncov) world health organization. b. coronavirus disease (covid- ) advice for the public coronavirus disease (covid- ) situation report: transmission of sars-cov- : implications for infection prevention precautions natural transmission model for severe fever with thrombocytopenia syndrome bunyavirus in villages in hubei province environmental contamination of sars-cov- in healthcare premises minimum infective dose of the major human respiratory and enteric viruses transmitted through food and the environment broad-spectrum virucidal activity of bacterial secreted lipases against flaviviruses, sars-cov- and other enveloped viruses current status of severe fever with thrombocytopenia syndrome virus in china sars-cov- : air/aerosols and surfaces in laboratory and clinical settings notes from the field: isolation of -ncov from a stool specimen of a laboratory-confirmed case of the coronavirus disease (covid- ) a pneumonia outbreak associated with a new coronavirus of probable bat origin china novel coronavirus investigating and research team. . a novel coronavirus from patients with pneumonia in china comparative virucidal efficacy of seven disinfectants against murine norovirus and feline calicivirus, surrogates of human norovirus funding for the preparation of this article was provided by reckitt benckiser llc. the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. the following grant information was disclosed by the authors: reckitt benckiser llc. joseph r. rubino and m. khalid ijaz are employed by reckitt benckiser llc, which provided funding for the preparation of the manuscript. the other authors have no financial interest in reckitt benckiser llc. raymond w. nims is employed by rmc pharmaceutical solutions, inc. and received a fee from reckitt benckiser llc for his role in authoring and editing the manuscript. m. khalid ijaz, syed a. sattar, joseph r. rubino, and charles p. gerba, declare no financial or non-financial conflicts of interest in this work. m. khalid ijaz conceived the review approach, analyzed the data, prepared figures and/or tables, authored or reviewed drafts of the paper, and approved the final draft. syed a. sattar analyzed the data, authored or reviewed drafts of the paper, and approved the final draft. key: cord- -ungilw s authors: rice, louis title: after covid- : urban design as spatial medicine date: - - journal: urban des int doi: . /s - - - sha: doc_id: cord_uid: ungilw s this article draws out key implications for urban designers from the covid- pandemic, particularly the relation between urban design and health. the entire world is facing the same acute health emergency of covid- which is already impacting half of the global population, and as the majority of the world now inhabits urban settings, urban dwellers are the most affected. urban design already plays an important role in determining the health of urban populations but this relationship is often unclear, undervalued or ignored. the field of medicine is expanding to include all professionals who have an impact on the health of others, and this expanded field includes the urban design profession. after covid- , urban design ought to become a form of spatial medicine, whereby the design of built environments positively contributes and facilitates human and planetary health and wellbeing. within months of its arrival, covid- already affected the lifestyles of billions of people worldwide-as a direct response to a health issue. the covid- event could arguably be described as the biggest medical, social, economic and cultural experiment in human history. governments worldwide are revising their policies to avert covid- ; this dramatic foregrounding onto one single issue, i.e. 'health', is rarely enacted outside of wartime. a consequence of covid- has been the sudden and significant change in the way we live, with new and unfamiliar modes of behaviour required during the pandemic lockdown. what society might learn from this 'living laboratory' on wellbeing is still unfurling. however, this heterogenous period offers a unique opportunity to understand the pre-and post-covid- implications for urban design. over half of the global population is now in some form of lockdown condition restricted to their homes and neighbourhoods (desantis ). whilst this has precipitated untold disruption and many challenges, it has also become a period of reflection. at the heart of the covid- epidemic is greater focus and public attention on the relationship between contemporary urban lifestyles and health. during the covid- lockdown, there are changes to the determinants of health, the diverse range of environmental, economic and social factors that impact on human wellbeing, compared to the pre-covid period. the current focus of covid- -related policy is targeted on human health. the initial period is all about reducing deaths and illness from one particular infection (almost regardless of economic or other costs). aside from the direct impacts of the covid- virus on physical health, there are a number of associated and indirect harmful repercussions on health including loneliness, depression, domestic violence and the unintended consequence of people not accessing hospital for e.g. cancer treatments (dore ; douglas et al. ) . the social isolation practices currently experienced during covid- lockdown are highlighting the importance of 'social' health. conversely, there are also some beneficial consequences of lockdown to health, for example, many urban areas have experienced significant reductions to air pollution, noise pollution, traffic congestion, crime, whilst also seeing increases the built environment plays a huge part in determining population health. urban designers can play a significant part in improving or exacerbating many health outcomes through their design decisions. the who ( ) defines health as "a state of complete physical, mental and social well-being"; twenty-first century urban populations are facing myriad health challenges: non-communicable diseases, climate change-induced hazards, new communicable diseases, ageing populations and socio-lifestyle risks (who a). health is a complex nexus of inter-related factors that impact on human and planetary health. more than half of the world is now living in urban environments, a figure set to increase by . billion by (un department of economic and social affairs ). urban environments impact, or structure, many of the key determinants of health for the majority of the global population. as such, the role of urban design as a determinant of health is increasingly recognised and the mechanisms through which it affects and impacts individual and societal wellbeing are acknowledged, particularly as contemporary health challenges require interdisciplinary solutions (azzopardi-muscat et al. ; barton and grant ; carmichael et al. ) . a "unified front is needed to turn the tide" against these urban lifestyle health issues (bloom et al. ) . in response, medicine is radically departing from its more traditional realm of doctors, nurses, hospitals and pharmaceuticals to embrace an 'expanded field' of professions, practices, approaches and policies (geddes et al. ; royal society for public health ) . this expanded field of medicine (aka medicine + or medicineplus) includes a diverse range of professionals not typically considered part of the medical world. one definition of medicine + would include an urban designer as someone: "not a specialist or practitioner in public health, but has the opportunity or ability to positively impact health and wellbeing through their… work" (centre for workforce intelligence (cfwi) and royal society for public health (rsph) ). one of the unintended (but arguably welcome) consequences of covid- is the rethinking towards how stakeholders and actors might play their part in delivering health and medicine+. in the midst of the covid- event, 'key workers' include (along with doctors, nurses, carers, etc.) a heterogenous assemblage of delivery drivers, shelf-stackers, fruit pickers, refuse collectors, public service broadcasters, teachers, border security, postal workers and telecommunications engineers (department for education ). this incongruous collection of workers illustrates how an expanded field of medicine+ might look, and urban designers should be added to that list. the who has called for 'health in all policies' to ensure that health is included in every policy and decision-making process across a wide range of disciplines and industries (and has been one of the drivers behind expanding the field of medicine+). 'health in all policies' is slowly beginning to be implemented as a 'health in all designs' strategy (sometimes referred to as 'design for health') (rice ). there are clear implications for the urban design profession, with concomitant changes required to the profession's guiding values and principles with a refocus onto health. in a post-covid- context, if urban design is to embed health at its core, it will need to alter the dna of its values and beliefs. health has been ignored in most of the 'canonical' urban design texts and theories. if we examine urban design literature for reading lists for the majority of urban design courses at universities (araabi ) , these key books rarely, if ever, address health or wellbeing. for example, the seminal urban design texts: image of the city (lynch ) , architecture of the city (rossi ) , responsive environments (bentley et al. ) and learning from las vegas (venturi et al. ) do not mention 'health' at all, whilst concise townscape (cullen ) , urban design compendium (davies ), life between buildings (gehl ) , a new theory of urban design (alexander et al. ) and collage city (rowe and koetter ) only mention 'health' a handful times at most. it is clear that the central tenets of urban design theory have not been explicitly concerned with health. nonetheless, it could be argued that many urban design texts and guidelines do relate indirectly to health in their ambition to produce improved contexts for human habitation. however, if the urban design profession is to embed health at its core, it needs to explicitly and directly re-connect health into its founding principles. the covid- event is perhaps an appropriate juncture for 'health' to be considered as a new tenet for the urban design profession? there are many aspects of a healthy city that lie outside the auspices of an urban designer's role-nevertheless there is still a significant range of health determinants that are controlled by the urban design profession. "design can be defined as the human nature to shape and make our environment in ways without precedent in nature, to serve our needs and give meaning to our lives" (heskett , p. ) . design spans across numerous aspects of the urban condition and it is important to understand the relationality across those scales. urban designers play their part in the widespread practice of design in the contemporary world (most of which is designed to some extent) "from the details of daily objects to cities, landscapes, nations, cultures, bodies, genes, and … nature itself" (latour , p. ) . the post-covid- practice of urban design may be described as a form of 'spatial medicine' (fig. ) . the term medicine, etymologically derived from the latin 'medeor' meaning a 'healing art', is fitting as urban design is both an art and a science, and good urban design can contribute as a 'healing art'. as medicine moves away from prescribing pills, it transfers towards 'social prescribing' and 'nature prescribing' which direct people to undertake restorative activities or engage with the natural world in order to improve their health. healthy urban design can become a form of 'spatial prescribing' whereby designs would actively and systematically aim to create healthier urban environments in which societies' and individuals' wellbeing can flourish. urban designers imagineer, vision, curate and create new built environments and are involved in modifying, retrofitting and regenerating existing urban areas, as such they hold a unique position to improve health in a number of ways (marsh et al. ) . the expertise, competences, capacity and creativity of urban designers provide a potential roadmap for innovative, experimental and radical approaches to enabling healthier urban lifestyles. there are already many guidance documents on the salient aspects of urban design to be considered. across a range of different texts, articles and books, there is a commonly agreed set of principles, if we take those described by carmona et al. ( ) , a frequently cited source for urban designers, there are six sub-categories: . morphological dimension . perceptual dimension . social dimension . visual dimension . functional dimension . temporal dimension these sub-categories comprise the wide range of issues that impact on humans, the natural world and planetary health. the terminology differs across authors but the content is broadly the same. whilst it might be tempting to add a 'health dimension' that would perhaps not be appropriate nor optimal, health should be integrated into these six categories instead. the goal of healthy urban design should be constituted within these six dimensions. carmona et al. ( , p. ) describe urban design today as "the process of making better places for people than would otherwise be produced"; this is not a particularly high benchmark and evidently not one that assures good health outcomes nor improves wellbeing. thus, the aim of healthy urban design is not to add more categories or dimensions for urban designers to contemplate, rather the required change being the level of fig. the nexus of urban design as spatial medicine+ commitment and nature of ambition to achieve urban design outcomes that can improve human health. as part of the transition towards wellbeing, one aspect of mainstream urban design urgently needs to be challengedour relationship with nature. many of the existing key urban design texts, books, precedents and guidance documents underplay or undervalue the significance of natural world. new and existing urban contexts must respond to the biological world and rebalance the ecological system far better than previously. the call for a reconnection to nature and need to "live in harmony with nature" (attenborough ) relates directly to covid- . the current scientific consensus is that coronavirus originated in animals and made the leap to human species very recently (calisher et al. ) . evidence suggests that covid- came about as anthropogenic activities, population growth, urbanisation and the concomitant reduction in habitats for wild plants and animals have exerted too much pressure on the natural world and the rise in new communicable diseases (daszak et al. ; ahmed et al. ) . the impacts and drivers of anthropogenic activities are manifold from climate change, plastic pollution, species extinction, industrial agriculture, overconsumption of resources as well habitat destruction (díaz et al. ) . unprecedented population growth and urbanisation "lead to encroachment into natural habitats and closer encounters with wildlife and zoonoses, and… provides opportunities for zoonotic infections" (lee et al. ) , i.e. an increase in new diseases transmitted from animals to humans as we encroach into, disrupt and degrade the natural world (fig. ) . prior to covid- , the rise of these new communicable diseases was deemed a "hidden 'cost' of human economic development" (jones et al. ). the 'hidden costs' of mistreating nature in this way are now being revealed through the impacts of covid- . not enough urban design guidance assesses the importance of the natural world sufficiently important. the intergovernmental platform on biodiversity and ecosystem services (ipbes) main goal is "strengthening the science-policy interface for biodiversity and ecosystem services for the conservation and sustainable use of biodiversity, long-term human well-being and sustainable development" (ipbes ). this goal should also form the guiding principle of post-covid- urban designsustainability, wellbeing and nature. there is a need for greatly expanding the presence and function of nature in urban areas by rewilding cities, bringing nature back into everyday contact with urban residents, provide urban agricultural opportunities, implementing green infrastructure and planting billions of trees. there are myriad rewards from these greener solutions, not just for the natural world, but also economic, social, climatic and health benefits (ulrich ; hartig et al. ; kaplan ; elmqvist et al. ; kabisch et al. ) . this greenification has the potential to transform urban realms into much more natural, wilder and restorative places. as we move out of the covid- period, a range of other related health issues may emerge. health has previously been much lower down in priority for most decision-makers which tend to regard economic issues more highly. if we return to business-as-usual as in the pre-covid- era, politicians, industry and communities must reflect on the large range of health risks that were previously deemed 'acceptable' or economically unavoidable. for example, according to the who ( b) "air pollution kills an estimated seven million people worldwide every year", these deaths mostly occur in urban areas and could be largely avoidable through the implementation of healthier urban design. air pollution is merely one risk factor responsible for mortality, there are many other pre-covid- urban health issues that may return if action is not taken. will the decision-makers of post-covid- consider it acceptable to permit a return to so many millions of (largely avoidable) deaths, particularly having made such an effort to avoid deaths from a different source? if so, it questions the logic of nearly bankrupting the global economy in order to save lives from one health risk-if only to return to a situation of harming human life via other urban risks? covid- has in the short term brought new focus and foregrounding of health, and when we transition to the post-covid- era there must be more awareness and foregrounding of health and evidence-based decisions for urban design. does urbanization make emergence of zoonosis more likely? evidence, myths and gaps a new theory of urban design a typology of urban design theories and its application to the shared body of knowledge new deal for nature. speech to world economic forum synergies in design and health. the role of architects and urban health planners in tackling key contemporary public health challenges urban planning for healthy cities responsive environments: a manual for designers the global economic burden of noncommunicable diseases statement in support of the scientists, public health professionals, and medical professionals of china combatting covid- urban planning as an enabler of urban health: challenges and good practice in england following the planning and public health reforms public places, urban spaces: the dimensions of urban design centre for workforce intelligence (cfwi) and the royal society for public health (rsph) department for education. . critical workers who can access schools or educational settings half of earth's population is now on coronavirus lockdown as cases exceed million. the people the ipbes conceptual framework-connecting nature and people covid- : collateral damage of lockdown in india mitigating the wider health effects of covid- pandemic response benefits of restoring ecosystem services in urban areas the marmot review: implications for spatial planning. london: the marmot review team life between buildings: using public space the concise townscape restorative effects of natural environment experiences toothpicks and logos: design in everyday life what is ipbes? establishment of ipbes global trends in emerging infectious diseases the health benefits of nature-based solutions to urbanization challenges for children and the elderly-a systematic review the role of nature in the context of the workplace a cautious prometheus? a few steps toward a philosophy of design (with special attention to peter sloterdijk) epidemic preparedness in urban settings: new challenges and opportunities urban design compendium the image of the city a guide to architecture for the public health workforce a health map for architecture: the determinants of health and wellbeing in buildings the architecture of the city collage city rethinking the public health workforce view through a window may influence recovery from surgery world urbanization prospects: the revision of world urbanization prospects learning from las vegas: the forgotten symbolism of architectural form charter of the world health organization health risks in cities world health organization. b. air pollution. who report data key: cord- - gk d p authors: kumar, ramya; kateule, ernest; sinyange, nyambe; malambo, warren; kayeye, shadrick; chizema, elizabeth; chongwe, gershom; minor, patrick; kapina, muzala; baggett, henry c; yard, ellen; mukonka, victor title: zambia field epidemiology training program: strengthening health security through workforce development date: - - journal: pan afr med j doi: . /pamj. . . . sha: doc_id: cord_uid: gk d p the zambia field epidemiology training program (zfetp) was established by the ministry of health (moh) during , in order to increase the number of trained field epidemiologists who can investigate outbreaks, strengthen disease surveillance, and support data-driven decision making. we describe the zfetp´s approach to public health workforce development and health security strengthening, key milestones five years after program launch, and recommendations to ensure program sustainability. program description: zfetp was established as a tripartite arrangement between the zambia moh, the university of zambia school of public health, and the u.s. centers for disease control and prevention. the program runs two tiers: advanced and frontline. to date, zfetp has enrolled three fetp-advanced cohorts (training residents) and four frontline cohorts (training trainees). in , zfetp moved organizationally to the newly established zambia national public health institute (znphi). this re-positioning raised the program´s profile by providing residents with increased opportunities to lead high-profile outbreak investigations and analyze national surveillance data-achievements that were recognized on a national stage. these successes attracted investment from the government of republic of zambia (grz) and donors, thus accelerating field epidemiology workforce capacity development in zambia. in its first five years, zfetp achieved early success due in part to commitment from grz, and organizational positioning within the newly formed znphi, which have catalyzed zfetp´s institutionalization. during the next five years, zfetp seeks to sustain this momentum by expanding training of both tiers, in order to accelerate the professional development of field epidemiologists at all levels of the public health system. every nation needs a public health system that can detect and respond to domestic and global public health threats in a timely way [ ] [ ] [ ] . many nations in sub-saharan africa face challenges, such as a shortage of adequately trained personnel in the public health sector including a lack of trained field epidemiologists [ ] . field epidemiologists (i.e. disease detectives) collect, analyze, and interpret data for evidence-based decision-making. epidemiologists bolster public health surveillance systems, which can help a country better understand their burden of disease and allocate limited resources. epidemiologists quickly detect and respond to disease outbreaks, and provide recommendations for evidence-based interventions. their efforts can reduce morbidity and mortality and reduce the risk of diseases spreading across borders [ ] . these functions are even stronger when networked within an organized public health system, such as a national public health institute (nphi) [ , ] . the world health organisation (who) recognizes a strong public health workforce as critical to compliance with the international health regulations [ ] . the ihr monitoring and evaluation framework recommends a target of one trained field epidemiologist per , population [ ] . according to this who standard, zambia-a country of . million people would need to employ field epidemiologists. to this end, the ihr´s joint external evaluation (jee) tool recommends that countries establish field epidemiology training programs [ ] . despite the threat of epidemic-prone diseases such as measles, typhoid, cholera, and avian influenza, in the zambian ministry of health (moh) employed only two epidemiologists [ ] ; both were stationed at moh headquarters in lusaka. outbreaks were typically investigated in an ad-hoc manner, and although outbreak investigations were summarized in reports, these reports were not stored in an easily-accessible public repository, or published in the literature. as part of a multi-faceted approach to strengthen health security in zambia, the moh established its field epidemiology training program (fetp) in . this program was created in order to increase the number of trained field epidemiologists who could investigate public health events, strengthen routine disease surveillance, and analyze data to drive evidencebased decision making. this paper describes the development of zambia´s fetp as a strategy to strengthen health security, while highlighting solutions to start-up challenges, and making recommendations to ensure program sustainability five years after the program launch (september -october ). zfetp description: zfetp was established by the zambia moh in as a tripartite arrangement: ) the moh launched the program within the department of disease surveillance and response and provided the trainees with field placement sites; ) the university of zambia (unza) school of public health cultivated epidemiologic and biostatistical knowledge through didactic coursework; and ) the u.s. centers for disease control and prevention (cdc) provided funding, technical guidance and mentorship. from program inception, u.s. cdc has provided technical and administrative support via a full-time in-country resident advisor, public health specialists, and masters-level epidemiology fellows. the program is currently physically housed within the zambia national public health institute (znphi) and is advised by a steering committee comprised of representatives from moh, unza school of public health, u.s. cdc, national health research authority (a national regulatory body for research), and the unza school of veterinary medicine. the zfetp aims to: ) develop capacity to train public health professionals in applied or field epidemiology; ) provide epidemiological services to strengthen health security at national, provincial, district and local levels; and ) reduce the burden of priority public health problems through strengthened epidemiology capacity and the service provided by fetp trainees [ ] . zfetp conducts two training tiers (fetp -advanced and fetp -frontline) to strengthen surveillance and epidemiological skills at national and subnational levels of the public health system. fetp-advanced: zfetp-advanced is a two-year, full-time program that began in and consists of approximately % classroom training and % fieldwork. trainees (i.e. residents) spend approximately seven months in didactic coursework at unzasoph ( months of coursework and month of examinations), followed by months in field placements. during the field placements, the residents receive handson training and experience in evaluating public health surveillance systems, investigating disease outbreaks, and conducting hypothesis-driven epidemiologic analyses that address priority public health issues at local or national levels. successful residents receive a masters of science (msc) in epidemiology. zfetp-advanced builds competencies in public health surveillance, outbreak response, public health research, and scientific communication, with the expectation that graduates will assume public health leadership positions, and serve as mentors to future trainees and junior field epidemiologists [ ] [ ] [ ] . currently, only moh employees are eligible for zfetp -advanced, and employees must take study leave from their fulltime positions. moh continues to pay their salaries during training, and residents receive support that includes housing, university tuition, equipment (e.g. laptops, cameras), and internet bundles. in return, graduates incur a two-year service obligation to the government of the republic of zambia (grz) after completing training. from september through , zfetp has enrolled three advanced cohorts, graduating a total of residents (table ) ; the majority of graduates work in the capital city of lusaka ( figure ). an additional residents are scheduled to graduate in september . zfetp enrolls health professionals from various educational backgrounds beyond medicine, such as laboratory sciences, public health, population studies, epidemiology, and nursing (table ) . this approach promotes the exchange of knowledge and skills, and contributes to a multi-disciplinary response to public health events. zambia´s fetp-frontline is an in-service program launched in . it is primarily focused on strengthening surveillance and enhancing early outbreak detection at sub-national levels of the public health system. similar to zfetp-advanced, zfetp-frontline trainees must be moh employees. frontline accepts surveillance officers and health directors from districts and provinces across the country. the target is to train at least surveillance officer in each district by . to date, the program has enrolled cohorts and graduated trainees from november through (table ) ; ( %) out of districts have at least one trained frontline resident ( figure ) . a detailed description of fetp-frontline has been published previously [ ] . in short, fetp-frontline includes three -week workshops. through these workshops, trainees learn the components of successful public health surveillance, methods to improve data quality, methods to analyse and interpret surveillance data, and how to investigate cases to assess outbreak potential. following the workshops, trainees spend one to two months at their usual worksites, where they build and document competencies in disease surveillance through program deliverables such as data quality audits. thus, trainees are expected to make improvements to the surveillance system by incorporating these program deliverables into their routine work. zfetp has adapted the standard fetp-frontline curriculum to meet the changing needs of the moh. for example, in , unza requested that zfetp enroll zfetp-advanced candidates with more experience in data analysis, in order to thrive in the academic rigor of the unza msc program. to meet this need, zfetp added one week of training in epi-info, plus leadership and management skills to the standard fetp-frontline curriculum for frontline cohort . zfetp has also demonstrated flexibility during public health emergencies (or public health events). for example, in (frontline cohort ), the minister of health requested that the zfetp-frontline training be extended by two weeks so that trainees could apply their new skills in outbreak investigation and response to support a large cholera outbreak response in lusaka. in , the moh committed to establish the zambia national public health institute (znphi) as a national public health center of excellence for public health security. the main mandate of the znphi is to improve the health of the people through disease prevention, surveillance and disease intelligence, early detection and response to outbreaks, and health security workforce development. around the world, nphis are focal points for countries´ public health activities, overseeing public health functions that may have previously been spread across multiple entities [ , ] . a functional nphi strengthens public health functions through better coordination of programs and activities. nphis can support and sustain investments in health security by helping countries strengthen sustainable public health competencies and achieve ihr compliance, as well as serve as the functional homes for health security activities. in zambia, znphi consolidates the core public health functions of surveillance, outbreak investigation, public health emergency management, information systems, laboratory networks, public health research, and workforce development into one institute [ ] . in , all disease surveillance activities moved to the znphi; this change included zfetp, which moved into the znphi´s workforce development (wfd) pillar. since then, zfetp is now documented within the official grz organizational structure, bringing greater visibility to the program across the government and with partners. residents participate in high-level strategic meetings and trainings that take place at the znphi, and enjoy strong connections to the africa centres for disease control and prevention (africa cdc), which is a technical institution of the african union that aims to strengthen national capacities to detect and respond quickly and effectively to disease threats [ ] . under africa cdc´s operating model, zambia serves as the regional collaborating center (rcc) for the southern africa region; znphi currently hosts the southern africa rcc. bringing zfetp under the znphi positioned zfetp to achieve greater impact. because znphi also houses the public health emergency operations center (pheoc) and has responsibility for outbreak investigations, zfetp-advanced residents are natural first responders to public health events at the national level. additionally, with ready access to and analysis of national surveillance data, zfetp residents are well placed to detect potential outbreaks early. zfetp residents and graduates are key members of outbreak response teams, and the incident management structure of the pheoc (when activated). following the completion of a response, residents work with the znphi information unit to rapidly disseminate findings in the quarterly public health bulletin, the health press, which is also housed within znphi. zfetp receives financial and technical support from grz, and from multiple partners. grz has provided financial support since program inception. initial support was primarily in-kind, such as paying residents´ salaries, providing meeting spaces, and providing a pool of public health professionals who could serve as field mentors. recent support has expanded to include supporting a portion of the frontline workshops and travel for outbreak investigations. to date, the largest financial contributor has been u.s. cdc, with funds primarily from the u.s. president´s emergency plan for aids relief (pepfar) and the u.s. president´s malaria initiative (pmi). in , the united kingdom´s department for international development (dfid) began providing financial support for zfetp-frontline. zfetp is linked to other fetps as a member country of the african field epidemiology network (afenet) and training programs in epidemiology and public health interventions network (tephinet). a future goal of the zfetp-advanced is to achieve tephinet accreditation, which will require a commitment to continuous quality improvement and full institutionalization, both critical for sustainability. furthermore, the znphi is a member of the international association of national public health institutes, which has worked with cdc and other partners to strengthen the znphi as zambia´s premier public health institute [ ] . in zambia, hiv remains the leading cause of death [ ] . government entities like the national hiv/aids/sti/tb council (nac) value the importance of strengthening the public health workforce in order to analyse routine hiv surveillance data from government health information systems [ ] . zfetp residents´ work in hiv exemplifies the service component of fetps, whereby residents learn while providing service to moh by tackling key hiv issues during the completion of their competencies. for example, in fulfilment of their surveillance evaluation competency, zfetp residents have identified gaps in case-finding among infants born to hiv-positive mothers. in fulfilment of their planned epidemiologic study competency, residents have described the patterns of hiv infection in female sex workers, explored the role of older men who exchange gifts and money for sex with younger women, identified factors associated with low uptake of hiv testing and treatment in young men (who have the lowest testing and treatment rates in zambia) , and analysed factors associated with poor viral load suppression. in zambia, malaria is endemic with nearly million people at risk of being infected with p. falciparum, and a population incidence of per , persons [ , ] . pmi is making longterm investments in public health workforce development by supporting one or two residents in each advanced cohort. these pmi-supported residents are assigned to the national malaria elimination centre (nmec), where they receive malaria-specific training, and in turn they support nmec´s goal of ending malaria by undertaking priority projects. they have improved malaria surveillance by evaluating the existing surveillance system and examining ways to improve the reporting of malaria data from private facilities to the moh´s integrated disease surveillance and response (idsr) system; investigated clusters and outbreaks of malaria; investigated knowledge, attitudes, and practices towards malaria prevention in high-risk districts; and investigated factors associated with health-seeking behaviours among parents or guardians with febrile children under age five [ , ] . one hallmark of the zfetp is its contribution to outbreak response in zambia, including recurring outbreaks such as typhoid fever and anthrax, in addition to less-well documented outbreaks such as konzo, (a neurological disease characterized by abrupt onset of an irreversible, non-progressive, and symmetrical spastic para or tetraparesis that is associated with cassava poisoning) [ ] . residents, as part of these investigations, have performed descriptive analyses and conducted case-control studies in order to make disease control policy recommendations based on epidemiologic evidence. as a result, outbreaks are investigated more often and more thoroughly, resulting in numerous publications, and presentations at national and international scientific symposiums on a wide variety of diseases such as meningococcal meningitis, tungiasis, cholera, foodbore diseases, typhoid fever, mumps, and bubonic plague [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . zfetp´s response to a large cholera outbreak in lusaka exemplified zfetp´s impact on outbreak response. during october -march , the moh recorded an estimated , cholera cases and fatalities. zfetp residents described the affected areas and highlighted gaps in safe water and sanitation: only one-half of households understood that cholera was transmitted via contaminated water, and only one-third of households were drinking water with adequate levels of chlorine. the residents then conducted a case-control study to investigate risk factors for morbidity, and found that cases had increased odds of drinking borehole (i.e. well) water [ ] . based on this information, grz installed emergency water tanks that contained chlorinated water, and the outbreak came to an end. during this outbreak, residents also staffed the public health emergency operation centre (pheoc). they conducted cholera vulnerability risk assessment and mapping, and generated evidence-based research for decision making. they also participated in oral cholera vaccination campaigns, as well as disease sensitization and community health education. to date, the zfetp has relied on outside funding for most program costs. this reliance on external funding poses risks to the program, especially if that support was to suddenly dissipate. to mitigate this risk and to chart a path towards greater institutionalization and sustainability, grz has begun to increase domestic financing for zfetp. the government has committed to supporting fetp expansion, as evidenced through the creation of a budget line in the national approved budget for expenditure [ ] . additionally, the national action plan for health security will be launched by the president of zambia; again, showing the high-level political will to strengthen health security in the country. in addition, znphi has engaged with partners to diversify funding sources. zfetp´s long-term staffing strategy includes several permanent positions: ( ) a program manager, who provides overall leadership and decision-making, sets strategic direction, and advocates for resources; ( ) a program administrator, who provides day-today operational oversight and manages program finances and logistics; ( ) an fetp-advanced program coordinator, who oversees advanced recruitment and activities and coordinates mentors; ( ) a fetp-frontline program coordinator, who oversees frontline recruitment and workshops and coordinates mentors; and ( ) a driver. currently, only two of these positions (program manager and administrator) are filled, and both are dependent on u.s. cdc funds. as of the time of writing, the grz intends to formally fund the full structure of staff at the znphi once parliament signs the znphi bill into law. this will allow znphi to hire additional staff to meet the zfetp´s staffing needs. inadequate mentorship: zfetp seeks to use advanced graduates to mentor current residents, both in fetp-frontline and fetp-advanced. however, because the program is new, the number of graduates (i.e. potential mentors) is low. mentoring is not included in the standard moh job description; thus, even the best mentors find it difficult to create time to work with residents. finally, fetp-advanced graduates are not distributed evenly across the country; half remained in the capital city following training, and one province has no advanced graduates. thus, mentoring residents and trainees in hard-to-reach areas of the country can be challenging and resource-intensive. as zfetp graduates additional advanced cohorts, the number of qualified mentors will grow, and this will help to alleviate the current mentoring gap. in the meantime, a newly formed alumni forum will provide a networking platform for all zfetp alumni to mentor and collaborate, and to serve as a pool of potential responders for outbreaks. additionally, zfetp plans to keep the momentum of graduates as mentors through a variety of innovations such as revising moh work plans to include mentoring in job descriptions, holding mentor-specific workshops, handing out awards to recognize superior mentoring, and providing opportunities for mentors to travel to conferences where their mentee´s work has been accepted. further, discussions are underway to establish positions for field epidemiologist within the moh and znphi structures; a move that will clearly define career paths for the graduates. the zambia fetp has been successful in responding to public health concerns and emergencies, such as high-profile outbreak investigations, and these epidemiologic investigations have contributed to the body of research in zambia. housing the program within the znphi, which oversees national disease surveillance and outbreak response, has increased zfetps visibility and catalyzed its impact and institutionalization. within a relatively short time, the zfetp has made clear contributions to national health security. the next years will be important to continue the program´s path toward full institutionalization and sustainability, and to implement continuous quality improvement efforts to address the challenges which face all new fetps [ ] . along these lines, zfetp plans to develop and implement a plan to routinely evaluate both the frontline and advanced programs, in order to determine areas of success as well as areas in potential need of improvement. ministry of health public health department, zambia national public health institute, u.s. centers for disease control and prevention, world health organization, department of international development (dfid), university of zambia school of public health, field mentors, teams involved in outbreak response. in addition, we would like to thank costa malama and dr charles michelo for their contributions in establishing the zfetp program, and carrie carnevale of the u.s. cdc national public health institute program for her editorial contributions. world health organization. world health organization international health regulations progress in global surveillance and response capacity years after severe acute respiratory syndrome. emerg infect dis pubmed | google scholar . world health organization. essential public health functions, health systems, and health security: developing conceptual 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interests. key: cord- -znbqpwgu authors: aye, baba title: health workers on the frontline struggle for health as a social common date: - - journal: development (rome) doi: . /s - - -z sha: doc_id: cord_uid: znbqpwgu through the lens of health workers’ concerns, the article interrogates the impact of the neoliberal turn of the s on the loss of the ideal and pursuit of health as a social common. it highlights the great recession as a confirmation of the failure of the neoliberal project but notes that this the project continues with even greater frenzy. capturing the dynamics which inhibit the world health organization, it calls for mass mobilization to reclaim health as a social common. health workers have been the first line of humankind's defence against the rampaging incursion of the microbial world, in the shape of sars-cov- . they have received accolades from peoples and governments alike. in many european cities, people would come out on their balconies at a designated time every evening to shout in honour of health and social care workers. governments as well, joined this chorus, without government officials batting an eye. many questions were not considered or were left unanswered as the waves of applaud came. why were health and social care workers saddled with so much work such that many were running insane shift periods? why was there a global shortage of personal protective equipment (ppe) for so long? how seriously were decision-makers taking the important need to safeguard the health of those taking care of our health in this pandemic? some of these questions have been raised in several ways in the literature in this turbulent year. this tends to be as part of attempts to understand why the pandemic happened and how can a similar situation be avoided in the future. finding answers for these questions requires our grasping the root of the problem. it is the primacy of for-profit interests in health which undermine the provision of health as the fundamental human right and social common which it is meant to be. health, including that of the health and social worker has become a commodity. tons of applauses without systemic change, ushering in a post-neoliberal world would be empty. crises like the present pandemic present opportunities for structural change. health workers are on the frontline delivering much needed care across the world. they are also on the frontline of struggle to bring about such systemic change. this article contextualizes the problem by putting neoliberal health reforms in perspective. it then looks at efforts of health workers roles in the current period, despite daunting challenges and tries to understand why the best intentions of the world health organization might not be enough to ensure the realization of its mandate. it then concludes with a return to a fundamental point made in the alma ata declaration -a pressing need for a new global social compact, for health as a common to become reality. 'since the s, neoliberal health and social welfare policies around the world shifted resources from the public to the private sector'. this has had adverse effect 'on the wellbeing of health and human service care workers' as well as patients (abramovitz and zelnick : ) . health workers have faced increasing work intensity and less control on the job, leaving them 'emotionally and physically depleted'. high levels of on-the-job stress and burnout became a regular feature of their lives. this ideologically-driven decline of public expenditure in healthcare; privatization of healthcare services, and; dismantling of public health infrastructures (navarro : ) , went on overdrive from the end of the s as the fall of the soviet empire paved way for capitalist triumphalism of the neoliberal order, best captured with fukuyama's vision of the 'end of history' at the time (fukuyama ) . radical changes were made in the public sector as new public management (npm) became the norm in western countries, rolling back the welfare state of the post-world war ii order. the rights-based essence of public service delivery was eroded, in fact, if not always in words. along with privatization, cost cutting measures became engrained in the public sector in imitation of the supposedly inherent efficiency of the private sector. healthcare delivery was not spared. on the contrary health, as one of the fastest growing sectors of the economy (in an age where the value of everything was considered only as its worth in dollars or euros), was a major target of the neoliberal anti-public sector reforms. this was pushed through with a flurry of 'health reforms' which entailed marketization of healthcare delivery. the presence and influence of for-profit interests in health and social care grew exponentially. global healthcare companies, big pharmaceuticals and insurance firms grew in numbers, wealth, and influence. with the use of outsourcing, contracting out and diverse forms of public-private partnerships, they latched onto public health systems, milking it of resources. an increasing number of workers delivering health and social care in public health systems became fixedterm contract staff. as the welfare state was being rolled back in the west, the developmental-interventionist state which had been able to prioritize healthcare delivery was also being smashed in the developing world. international financial institutions played a key role in this. many countries were embroiled in debts after a series of economic setbacks in the s from the oil crisis to the volcker shock. as they turned to the international monetary fund and world bank in the s, they were slammed with structural adjustment programmes. and while imf loans are officially meant to help member countries tackle balance of payment problems, the conditionalities that went with these included setting caps on public sector employment. these ceilings have been identified as key impediments to hiring or retaining health sector workers, and are linked to medical "brain drain" as health workers migrate in search of better employment opportunities (kentikelenis : ) the great recession at the end of the s demonstrated the failure of neoliberalism in practice. but to reassert the resultant dent of neoliberal hegemony, governments stuck even more religiously with the ideology of this failed god. instead of less, we had more neoliberalization of health and care as well as social life as a whole. fiscal discipline was pushed through with austerity measures, as governments and international finance institutions did all they could to make working-class people bear the cost of economic recovery, while bailing out corporations whose profit maximization led to the crisis. the public wage bill was either cut or had caps put on it in out of by (ortiz et al. ) . health and social workers were particularly hard hit. for example, a guardian survey showed that nhs staff were the 'most stressed public sector workers' in britain. this is not surprising, as they are 'under-resourced and definitely understaffed' as one of the respondents of the survey said. and on top of that, they are underpaid. their wages were frozen for years and after that, wage increases were capped at % for another year until . the case in greece was no better. the salaries of healthcare workers were cut twice in . first by % in january and then by another % in june (economou et al. ) . in a world where profit had become god, with productivity and 'efficiency' its trusted servants, increases in health sector wages were considered at best as a cost disease (baumol and bowen ). but, as the pandemic shows quite clearly, reducing the value of human labour to the economic logic of productivity does great injustice to workers concerned and our collective humanity. to roll back the commodification of health and devaluing of the labour of healthcare requires holistic root and branch radical reforms aimed at enthroning universal public healthcare. the pandemic met a global health workforce that was understaffed, underpaid, under-resourced and overstressed. but health workers rose to perform what was close to miracles, putting their lives at risk to save lives. with their lived experiences at a critical hour for humankind, they demonstrated and emphasized the social commons that health in its essence is. from the doctors and scientists in china who dared local party officials to get information out on the new coronavirus, to the indian nurses and doctors who wore diapers to save personal protective equipment which was in short supply health workers demonstrated courage and self-sacrifice. marketization of healthcare prepared the ground for hospitals that felt like war zones as surges spiked in different countries. like the polish cavalry charge at krojanty in , ill-equipped though they have been, healthcare workers bought humankind time as much as they could, in the face of the rampaging sars-cov- . the task was made the more difficult by a number of interrelated causes within the neoliberal paradigm which had informed health reforms over the decades. the privatization of healthcare was one of such key determinants. analysis covering countries for example, that preponderance of private provision of healthcare as well as cross-cutting policies such as 'reduction in the number of hospital beds per people' result in significantly higher 'rates of covid- prevalence and mortality across countries' by up to . % and . % respectively (assa and calderon : ) . this analysis was concerned more with the direct impact of privatization and cuts in public hospitals beds on the higher risks of covid- prevalence and mortality. we need to also consider the indirect impact. the plummeting of public health investment in europe since contributed to increasing pre-existing health states which predisposed persons to being infected. for example, public health spending in england fell by £ m since . this might have 'caused , deaths and a rise in chronic conditions like diabetes, that incidentally also make you more likely to die from covid- ' (mackenzie : ) . as several former and serving united nations special rapporteurs point out, the pandemic exposes the catastrophic impact of privatizing vital services such as water and sanitation, and health. the social and economic determinants of health are as much part of the fabric of our collective humanity which should not be left to the determination of market forces. the consequences of the reign of such corporations over our social commons, as the pandemic shows, could be disastrous. the global shortage of ppe was a stark case of an emergency within the global health emergency. but it did not just happen. it speaks to how global supply chains have evolved to best serve profit maximization as the first law of social production, which explains why governments across the world were not prepared in several other ways, when the pandemic broke out. one of the lessons from the - sars outbreak was that ensuring the health of health workers and preparing for surge capacity must be accorded priority, to avert the worst impact of epidemic outbreaks. and several simulation exercises which should have informed governments and the international community to look beyond the logic of on-time production to ensure consummation of these priorities. these include nhs england's exercise cygnus which showed lack of crisis preparedness of the british government for a flu pandemic. the who's r&d blueprint for action to prevent epidemics' disease x in should likewise have also served as caution for stockpiling ppe. but, with for-profit interests upping policy formulation that puts people first, why keep capital expended on such essential equipment tied down before a pandemic's pandora escaped from its box? this demonstration of 'savage capitalism', as noam chomsky puts it, was not just passive in terms of not having needed medical devices ready, it was also active. as chomsky informs, drawing lessons from the ebola outbreak in , the obama administration entered a contract to make 'high-quality, low-cost ventilators' available for such eventualities as now befall the world was sabotaged by a corporation which bought the original smaller company contracted, because 'it was competing with their own expensive ventilators'. but while neoliberal hegemony continues to hold sway, pushing the maxim of there being no such thing as social commons, the pandemic forced the hands of several governments to take radical and far-reaching actions to safeguard the social commons, in the early months of the pandemic. these included the requisitioning of private hospitals, conversion of factories to produce needed medical devices, supplies and ppe. this was however not with the spirit of ubuntu which health workers demonstrated. these temporary measures did not necessarily amount to taking the private health facilities into public hands or their 'nationalization' as sensationalized in the press. there is a pressing need to go beyond the limited and feeble demonstrations of government's turn to seeming consideration of health as a social common, and only so during emergencies like the covid- pandemic. founded in as part of the multilateral united nations system, the world health organization has a mandate 'to act as the directing and co-ordinating authority on international health work' towards achieving the objective of 'the attainment by all peoples of the highest possible level of health' (who ) . from the s when the world bank delved into lending to the health sector on a large scale, this leading role of the organization has been challenged (clift ) . the rise of diverse global health initiatives over the last few decades have accelerated this whittling of who's real powers. and relatedly, its increasing reliance on voluntary contributions, including-indeed increasingly more-from philantrocapitalist foundations. this has severe long-term implications. these 'nonstate actors' influence has helped to consolidate the hold of private interests on the health system internationally and in countries across the world leading to; undermining of accountability mechanisms, institutional hybridization, weakening of 'public sector and government responsibility' for health and social care, fostering opacity and the illusion of a redistribution of wealth by the elite. the multi-stakeholderism promoted by philantrocapitalism, and perennial failure of governments to live up to their financial and other commitments whittle the capacity of who to serve in reclaiming health as a social common. it is against this background that such laudable resolutions that would have helped safeguard the health and well-being of health workers such as the working for health: five-year plan for health employment and inclusive economic growth have failed to translate into concrete steps on the ground. the politics of the covid- global response echoes the need for reinstatement of the who's leading role in international health. global health initiatives such as gavi and cepi occupy more or less equal place in the access to covid- tools accelerator (act-accelerator), while who cannot arrest the unfurling of vaccine nationalism. the neoliberal turn of the s represents a loss of the trajectory of social progress towards health as a social common. commodification and marketization of health which started with the incursion of international financial institutions at that period reflected a change in the global social and economic order to one of the most naked forms of capitalism. this laid the basis for nightmare which health workers have faced in the pandemic-overworked, underpaid and ill-protected. health works realize the need to change this situation. public services international, the global trade union federation which brings together thirty million workers across the world, about half of which are in the health and social sector has called for 'rapid changes in policies….that put people and planet over profit'. this requires advocacy and lobbying of the who and countries. but even much more it requires monumental social mobilization to restructure the world as we know it, with public health for all at the heart of such this. we must remember that it took 'the combination of militant social movements and structural changes in the economy' to give birth to 'the rise of the welfare state' (abramovitz and zelnick : ) . it is also important to note that the alma ata declaration recognized the fundamental importance of economic and social development (at the time envisioned as the 'new international economic order') for the fullest attainment of health for all and reduction of health inequities to become reality. 'the post-covid- age will usher in a new era of social and political relations' (horton : ) . but the nature of this is not pre-defined. it could be more of the same as the post-great recession age has been. we must contest it and fight for it to be an age of health as a social common-a post-neoliberal age. double jeopardy: the impact of neoliberalism on care workers in the united states and south africa privatization and pandemic: a cross-country analysis of covid- rates and health-care financing structures es?id= &lang=en. accessed ry_analy sis_of_covid - _rates _and_healt h-care_finan cing_struc tures performing arts, the economic dilemma: a study of problems common to theater, opera, music, and dance the role of the world health organization in the international system the impact of the financial crisis on the health system and health in greece the end of history? the covid- catastrophe, what's gone wrong and how to stop it happening again structural adjustment and health: a conceptual framework and evidence on pathways covid- the pandemic that should have never happened and how to stop the next one neoliberalism and its consequences: the world health situation since alma ata the decade of adjustment: a review of austerity trends - in countries world health organization (who). . constitution of the world health organization key: cord- -ze t authors: patel, mahomed s.; phillips, christine b.; pearce, christopher; kljakovic, marjan; dugdale, paul; glasgow, nicholas title: general practice and pandemic influenza: a framework for planning and comparison of plans in five countries date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: ze t background: although primary health care, and in particular, general practice will be at the frontline in the response to pandemic influenza, there are no frameworks to guide systematic planning for this task or to appraise available plans for their relevance to general practice. we aimed to develop a framework that will facilitate planning for general practice, and used it to appraise pandemic plans from australia, england, usa, new zealand and canada. methodology/principal findings: we adapted the haddon matrix to develop the framework, populating its cells through a multi-method study that incorporated the peer-reviewed and grey literature, interviews with general practitioners, practice nurses and senior decision-makers, and desktop simulation exercises. we used the framework to analyse publicly-available jurisdictional plans at similar managerial levels in the five countries. the framework identifies four functional domains: clinical care for influenza and other needs, public health responsibilities, the internal environment and the macro-environment of general practice. no plan addressed all four domains. most plans either ignored or were sketchy about non-influenza clinical needs, and about the contribution of general practice to public health beyond surveillance. collaborations between general practices were addressed in few plans, and inter-relationships with the broader health system, even less frequently. conclusions: this is the first study to provide a framework to guide general practice planning for pandemic influenza. the framework helped identify critical shortcomings in available plans. engaging general practice effectively in planning is challenging, particularly where governance structures for primary health care are weak. we identify implications for practice and for research. primary health care, and in particular general practice, will be at the frontline in the response to pandemic influenza. preparedness planning for this sector has lagged behind public health planning, despite evidence from sars [ , ] and influenza epidemics [ ] of the important role played by general practice. preparedness may be defined as the capacity to respond to a range of public health threats including natural disasters and infectious disease outbreaks, human-caused accidents and intentional attacks [ ] . there is an increasing recognition of the need for an 'allhazards' approach to planning that integrates acute clinical care, public health, and emergency management systems [ ] . since september , the us government has invested about $ billion to upgrade preparedness plans for emergency management systems [ , ] . there are three challenges for pandemic planning by general practice. first, there is no systematic framework for planning this sector's response. preparing for health threats and emergencies is an essential function of public health, but is not core business for general practice. second, the way in which ambulatory health services will interact with each other and with the broader health system response to a pandemic is unclear. general practitioners (gps) in canada [ ] , australia [ ] and the uk [ ] have expressed uncertainty about how to participate in such a response. third, planning and implementing changes for pandemic influenza across the health system is complex. although there is little evidence linking specific preparedness activities to effective system-wide responses to pandemic influenza [ , ] , change management theories point to a need for dynamic partnerships between general practices and other ambulatory care services, hospitals and public health departments [ ] . the strength and structure of these linkages vary around the world, depending on decentralisation processes, the regulatory and legal system, and financing within health systems [ , ] . although general practice, or family medicine, is organised differently in different countries, there is considerable potential for transferable learning at the meso-level of management planning [ ] . we aimed to develop a framework that will facilitate systematic planning for the general practice response to pandemic influenza and used it to appraise coverage of key elements in publicly available pandemic plans from australia, england, usa, new zealand and canada. to guide planning and to appraise available plans, we adapted the haddon matrix, a planning tool developed in the field of injury research and intervention [ ] , and more recently applied to the public health response to bioterrorism, sars [ ] , and pandemic influenza [ ] . the matrix consists of a grid of columns of four factors (human, agent, and physical and organisational environment) impacting upon the event [ ] . pandemic influenza may be perceived as a form of injury on a mass scale and the matrix helps us understand the multi-dimensional nature of epidemics and of the associated challenges that could be expected by general practice. the framework can be readily shared with public health units and other parts of the health system, as it identifies the general practice contributions to primary health care services and to public health surveillance and control. because all disasters are local, the matrix is flexible enough to allow a focused analysis of the smallest unit of study, such as an individual, or group of general practitioners. the methods used to construct the cells of the modified haddon matrix have been detailed elsewhere [ ] . in brief, a team with expertise in social science, public health and general practice reviewed objectives and strategies in who guidelines for preparing and responding to a pandemic [ ] to define the context and potential contributions of general practice. next, we undertook a narrative review of the peer-reviewed and grey literature on pandemic influenza to identify papers that elaborated strategies relevant for general practice. a search of the peerreviewed literature through pubmed using the terms 'general practice', 'family physician', 'family medicine' and various combinations of the terms 'influenza', 'epidemic', 'preparedness' and 'pandemic' yielded eligible papers from search results . the process of constructing the framework and populating the cells was informed by organisational theories that emphasise multilevel approaches to change from the individual to the broader health system [ , ] , and by methods for measuring [ ] and improving the quality [ ] of public health emergency preparedness. we tested our framework through interviews with a purposive sample of health professionals engaged in pandemic planning. nineteen general practitioners and practice nurses with expertise in pandemic planning were nominated by the two participating divisions of general practice, each of which was a national leader in disaster preparedness and response. eight general practice policy leaders were identified by representative organisations (australian medical association, royal australian college of general practitioners, australian general practice network). group interviews were held with state and territory public health leaders attending a national pandemic preparedness meeting. we held two workshops, attended by representatives of state and territory health services, commonwealth policymakers, non-government organisations, and general practice organisations. in addition, we conducted two focus groups of gps and nurses working in aged care in two cities. finally, we undertook four desktop exercises [ ] attended by gps, practice nurses and administrative staff. the five countries in this study had national response plans. contextualised detail about health-sector responses is contained in plans at the level of administrative decentralisation where decisions are made about patient-service groupings including general practice. in practice, this level was the state or provincial health departments in federal systems where those jurisdictions have responsibility for health service management and planning (usa, canada, and australia). in england, the managerial level for health services is located at the primary care trust (pct), while in new zealand it occurs at the level of the district health board. although these are not identical loci of health service governance, they were sufficiently similar in the planning aims for comparisons to be drawn. plans were obtained from websites of health departments of states or provinces (usa, australia, canada), district health boards (new zealand) and pcts (england) ( figure s ). for new zealand and england, publicly available records of board meetings were also examined. consumer information and isolated sub plans (e.g. for infection control) were excluded. plans for jurisdictions were identified; six were excluded as they addressed isolated aspects such as only the distribution of medications, or communication with the public, leaving plans suitable for analysis. of the five countries, canada exhibits the most variation between provinces in health system coordination. we examined the websites of canada's provincial regional health authorities (rhas, plans identified) and ontario's public health units ( plans identified) and local health integration networks (no pandemic plans identified). we excluded the rha and public health unit plans from inter-country quantitative analysis, as their level of devolution and/or responsibilities for health management differed from those examined in the other four countries, but have included descriptive details from some of the rha plans where they illustrate innovative approaches. all plans were examined by two clinicians, and searched for the following terms: primary care, primary health, ambulatory, general practice, general practitioner, gp, family practice, family physician. the roles of general practice/family practice in the plans were assessed across the four domains of general practice identified in the first part of this project. no attempt was made to quantify the extent of coverage of general practice in the plans as this rarely extended beyond a few sentences. where there was detailed coverage of an issue, we analysed the text and the health system context. the study was approved by the australian national university human research ethics committee and the national research and evaluation ethics committee of the royal australian college of general practitioners. written informed consent was obtained from participants. a conceptual framework of the general practice response to pandemic influenza is shown in table . the framework identifies four domains of practice: clinical services, public health responsibilities of general practice, internal (physical and organisational) environment of the general practice unit, and the macro-environment of general practice. in each domain, we list the key challenges to be anticipated by general practice during an influenza pandemic, and the type of responses that need to be addressed in the plan. table summarises the organisational levels in the five countries, the proportion of jurisdictions with accessible pandemic plans, and coverage of general practice in these plans. while almost all plans from us jurisdictions were accessible, three quarters of australian states/territories and one third of new zealand's district health boards had accessible plans. only % ( / ) of england's pcts had pandemic plans available in the public domain. figure s shows the jurisdictions and health management systems whose plans were included in this study; they comprise jurisdictions from the usa, from england, from canada, and each from australia and new zealand. table shows the number and rates of coverage of each of the four domains of the general practice response in jurisdictional plans of the five countries. the domain covered most frequently was influenza-related clinical care (in all plans from england and canada). overall less than half the plans mentioned non-influenza clinical care, with the exception being england, where % of pct plans mentioned non-influenza clinical care. public health surveillance was addressed in all plans from canada and new zealand and infection control in general practice in almost all plans from england and canada. functional linkages of general practice with other parts of the health system were addressed in almost all the english plans, but a smaller proportion of other plans. clinical care essential planning elements. this domain includes two sets of clinical care needs. the first, prevention and treatment of influenza, includes care for the surge in patients with acute respiratory illness, and for people at high risk of exposure to, or complications from, influenza. these aspects are discussed extensively in the literature [ ] [ ] [ ] [ ] . most people with influenza can be managed in the community, protecting hospitals by delaying or avoiding admission and facilitating early discharge. the second clinical care need is for non-influenza-related care. general practitioners provide most chronic disease care, though there is inter-country variation in their capacities to do this efficiently [ , ] . while activities like cervical screening may cease in a pandemic, chronic illnesses like diabetes or cardiac disease will still need management. some acute care usually undertaken in hospitals, like acute asthma or injuries, may be transferred to the community. in an earlier paper, we advanced a range of models of practice to balance clinical services for influenza and non-influenza care [ ] . in the recovery phase, the clinical needs of patients are for psychological care and chronic illness management. if the pandemic occurs in waves, as in - , recovery activities may need to be tempered by preparations for the next wave. coverage of essential elements in plans. all canadian and english plans outlined a role for general practice in clinical care for influenza. while only % of plans from the usa addressed clinical care for influenza by primary care practitioners (table ) , every us plan included guidelines on influenza management by hospital physicians. some plans articulated a surge in demand for influenza care as a threat to general practice's survival, and proposed assessment and treatment clinics as a way of protecting them [ , ] . in other plans [ ] [ ] [ ] the response to a surge was to support general practices to become more resilient by collaborating and changing their work practices. in two us state plans, the failure of the ambulatory care sector in the face of a surge was assumed. the planning challenge became to find ways to redeploy workers into other health care sectors [ , ] . most plans were sketchy on systems to maintain non-influenzarelated clinical care, with the exception of some pct plans, which included activities like triage, extended prescribing, identifying deferrable reasons for presentation, and management of more acute problems to protect hospitals [ , [ ] [ ] [ ] [ ] . the main non-influenza clinical area was mental health care, mentioned in six plans from the usa [ ] [ ] [ ] [ ] [ ] [ ] (reflecting a focus in the national plan [ ] ) and one canadian plan [ ] . coverage of the needs of vulnerable populations-the elderly, homeless, prisoners and the psychologically unwell -was most detailed in plans from canada and england. essential planning elements. this domain includes surveillance of influenza-like illness and influenza virology, and control of influenza in the general practice and the community. surveillance includes early diagnosis and notification, and specimen collection to confirm clinical diagnosis and to monitor viral characteristics and resistance to antiviral drugs. gps and private specialists are currently central to surveillance activities [ ] [ ] [ ] [ ] . in the early stages of the pandemic, it is likely that public health authorities will undertake contact tracing to facilitate containment, but their capacity to sustain this approach as the epidemic continues will be limited. general practice may then be expected to include contact tracing, and monitoring and support of people in quarantine or home isolation. other responsibilities may include prescribing and dispensing antiviral drugs and participating in mass immunisations against the pandemic strain of the virus. coverage of essential elements in plans. surveillance in general practice was mentioned in % of us plans and in only % of english plans, in all canadian and new zealand plans, and all but one australian plan ( table ). the low rates of coverage of surveillance in pct plans are not in accord with the uk plan which imputes to general practice a role in surveillance, and recommends that pcts operationalise this recommendation [ ] . the college of family physicians in canada is a partner in fluwatch, recruiting sentinel physicians to undertake surveillance, so this role is well understood within the canadian health sector. the role of general practice in contact tracing, in monitoring people in home isolation, and in distributing antiviral drugs is unclear in most plans. home care by gps for people in quarantine is mentioned in two us plans [ , ] , and one english plan [ ] , though the recently released guidelines for pcts anticipate a role for general practices in home care [ ] . in all country plans, dispensing antiviral medications was generally performed by public health units. only % of pct plans and % of us plans mention a role for primary care in dispensing antiviral medications. none of the canadian plans, and only one nz and two australian state plans, mentioned antiviral dispensing by primary care. the only plan to set out contingencies when decisions about dispensing may change was one canadian rha plan [ ] . although immunisation was mentioned most frequently after surveillance as a public health activity by general practices, in most plans the immunisations were against pneumococcal disease and seasonal influenza, but not mass immunisations against pandemic influenza. essential planning elements. this domain includes the physical environment of the general practice and its practice-level organisation. the risk of transmission of infections within the surgery could be minimised through separate waiting rooms and entrances, triage and personal protective equipment and handwashing facilities. hogg has outlined infections control procedures in the practice and the associated financial costs [ ] . some general practices (for example, those with small waiting rooms, or only one consulting room) may be deemed too much of a transmission risk to continue providing face-to-face services. the practice needs to develop strategies to maintain reliable and efficient access to essential drugs and equipment and influenza and pneumococcal vaccines. it also needs to strengthen the capacity of its communication technologies with patients and the broader health system, including telephones, faxes, internet, work-from-home technologies for staff, compatible software for sharing electronic medical records, and recall and reminder systems for patients. preparation at the organisational level relates mainly to business continuity plans. these plans should include leadership delegations, staffing contingencies, safe and flexible working hours and family care plans for staff, criteria for considering clinic closure, recruiting and training ancillary staff, early psycho-social support, support for making difficult clinical decisions, record keeping to ensure accountability for actions and 'inactions', use of antiviral medications, and plans for simulation exercises to complement training, and to evaluate and refine local practice plans. tools [ , ] and desktop simulation exercises [ ] are available to help gps plan for continuity. coverage of essential elements in plans. infection control strategies were well covered in plans from canada and england, but were mentioned in only % of us plans ( table ) . none of the plans provided an inventory of fixed features, such as size and layout of waiting room, or a single entrance, which could compromise infection control. business continuity was a focus of the english plans, which frequently referenced resources available on the uk resilience website [ ] . this aspect of preparedness was enhanced after the exercise winter willow simulation in february , and new pct guidelines addressing workforce planning [ ] . some pct plans addressed the need for general practice resilience in the face of workforce sicknesses [ ] , increased aggression from patients, and threatened loss of capacity in single doctor practices [ ] . few plans from other countries discussed business continuity for primary care in such detail. this may be because such issues are felt to be outside the normal purview of state or provinces, and to be the responsibilities of the businesses themselves or corporate interests. essential planning elements. this domain includes the overall organisation of, and interactions with, the health system that will facilitate or impede effective functioning of general practice services during a pandemic, including adaptation of relevant regulatory and financing systems. the health system requires a plan that adopts the 'all-hazards approach' and integrates roles, responsibilities and actions for acute clinical care, public health, and emergency management systems [ ] . this calls for coordination across general practices and other ambulatory care services to ensure primary health care needs within the community are effectively monitored and addressed; with hospitals to avoid/delay hospitalisation and facilitate early discharge; and with public health units to share responsibilities for contact tracing, monitoring and treating people in home isolation or quarantine, dispensing of anti-viral medications, and participation in mass immunisations against pandemic strains of the virus (when these become available). neighbouring general practices and other ambulatory care services will need local leadership with strategic approaches to collaborate and maintain services through a pandemic. england's pcts and new zealand's primary health organisations (phos) represent two ways of linking general practices under the governance of regional boards. these networks are consolidated by financial relationships between the pct or the pho and general practices. the links between australia's divisions of general practices and gps are purely voluntary. in the usa, managed care systems function as another way of linking ambulatory and hospital services. communication infrastructure between canada's family practitioners, % of whom are solo practitioners [ ], is still being developed, as is the incorporation of general practice into canada's pan-canadian public health network [ ] . the regulatory environment includes accreditation of retired medical practitioners and allied health professionals, laws and regulations which support or hinder the flow of qualified personnel across a jurisdiction's health facilities [ ] , and ensuring an appropriate medicolegal framework to support clinical decisions on prioritising medical care during a pandemic, for example, modifying clinical standards, deferring treatment, and restricting access to certain treatments. funding mechanisms for general practice may impact upon the capacity to provide extra services. in countries with fee-for-service payment systems, general practices may profit from a surge in attendances, but may equally run into business difficulties if they are short-staffed for prolonged periods. gps funded through a capitated system may have more freedom to alter their practice to provide different service mixes. in the post-event phase, patients and gps may require support for psychological recovery. it may be necessary to provide some formal relief through a system of locum gps from areas less affected by the pandemic. organisational partnerships at this stage may need to be with social services and mental health support services. coverage of essential elements in plans. countries with mechanisms for linking general practices with other sectors were more likely to address networking in their plans. ninety five per cent of english plans addressed systems to support collaboration between general practices (table ) . these plans addressed buddy systems, practice networks, and contingency plans for communities of practice. four of the six new zealand plans also addressed collaboration, though only one in significant detail; this plan outlined a distinction between key practices, and other practices which might decide to partner one another [ ] . of the three canadian provincial plans that addressed collaboration, the most comprehensive was from quebec, which identified a need to bridge the gap between salaried practitioners and independent physicians. the plan of the montreal regional authority [ ] operationalises this by setting up a system of active and sustained outreach by the public health department to independent physicians. the absence of plans for networking between general practice and public health is most marked in the usa. with the exception of louisiana [ ] , us plans which mentioned networking did so in one line, generally advocating partnership between private and public services without indicating how this might occur. louisiana's strategic approach built a participatory structure for rural practitioners through a partnership between the state public health department and the bureau of primary rural health care. the canadian national pandemic plan [ ] is framed around a set of ethical precepts incorporated into pandemic planning at the provincial and regional health level. the uk has recently released an ethical framework for policy and planning, though this has not yet been incorporated into planning documents [ ] . the regulatory framework most mentioned was in relation to credentialing for retired gps and other volunteers [ , , ] , and less frequently, indemnity [ ] . although most plans include coverage of the relevant public health legislation, no country's plan included an inventory of legislation relevant to general practice that might need to be amended. only one plan [ ] and the pct guidelines [ ] , canvas the potential of recompense for financial loss to a general practice. the only country in which the planning level coincided with the level that made decisions about funding of health care was canada. one regional health authority plan provided an outline of specific issues likely to affect physicians, and raised the possibility of reviewing funding mechanisms in a pandemic [ ] . there appear to be no ancillary plans addressing principles of altered funding for private physicians in a pandemic. this is the first study to provide a framework that brings together multiple functions, structural relationships and the responsiveness of general practice to prepare for pandemic influenza. the framework provides clarity of purpose and a structure to guide planning through four functional domains: clinical care, public health responsibilities, and the internal and macro environments of general practice. the domains have been structured as integral components of a complex system that can respond to uncertainty [ ] and be adapted for a given local setting and health system context. we draw three conclusions regarding general practice from our analysis. first, none of the jurisdictional plans addressed all domains of the general practice response during a pandemic. second, while many aspects of the first three domains are included in plans for general practice, there are critical gaps and inconsistencies in the fourth domain (macro-environment) that render some elements of the jurisdictional plan ungrounded or unrealistic. third, few plans addressed the broader ambulatory care context, including the need to engage private specialists and other allied health professionals [ ] . planning and implementing change across the health system is complex. targeting individual sectors for change (e.g. public health departments, hospitals or general practices) without securing reciprocal changes and strengthening inter-relationships across the health system, is unlikely to succeed [ , ] . planners must consider how connectivity across the health system might be strengthened to enable optimal use of general practice resources for planning [ ] . while this may be challenging, particularly in countries with weak governance structures for primary health care, omitting general practice input into the planning process may be considered unethical [ ] and counterproductive. limitations of the study: our findings are exploratory rather than definitive, and indicate directions for further planning and research. like any new tool, the framework and its application in a given context needs testing and refinement through simulation exercises targeting ambulatory care services as well as the broader health system. planning is an evolving activity that reflects a 'map' rather than a 'destination', and our findings provide a snapshot of the plans accessible in late . the scope and content of the plans will change over time, as seen in two countries that adjusted their plans after simulation exercises, exercise cumpston in australia [ ] and winter willow in the uk [ ] . interestingly, the former identified specific weaknesses in the involvement of the primary health care sector and made recommendations to better integrate primary health care providers into planning at the national and jurisdictional levels [ ] . national and sub-national pandemic plans may be intended to provide a strategic focus and not to elaborate on operational activities; it is possible the latter may have been addressed, but were not accessible at the time of our study. another potential limitation of our study is that the gaps we identified in many plans were grounded in theories about the ways to enhance the quality and outcomes of clinical care [ , ] or of public health preparedness planning [ ] . the science of preparedness planning is still maturing [ ] [ ] [ ] and there is relatively little systematic evidence for linking specific preparedness structures to the ability to implement efficient and effective responses [ , ] . two important limitations to the implementation of preparedness activities are uncertainties in knowing how much preparedness is enough [ ] and in having a measurable assessment of the outcomes of preparedness activities. it may be more meaningful to perceive of the activities as a 'preparedness production system' in which a variety of processes and activities have been completed to prepare for an optimal response [ ] . we are unable to comment on the extent to which these preparedness plans have been implemented, except in the case of those jurisdictions which have held pandemic exercises [ , ] . general practice response is rarely tested in pandemic exercises, which tend to focus on hospital and public health responses. a notable exception is operation sparrowhawk in singapore, where the feasibility of general practice influenza clinics was tested [ ] the haddon matrix is not a final check-list for preparedness planning but a problem-solving tool used as a starting framework for planning. the contents of each cell of the matrix help identify a particular problem or challenge that needs to be addressed. we recognise that the challenges will be neither static over time, nor uniform across general practices; responses will have to be modified in the context of the general practice setting as the pandemic evolves and as other parts of health system, particularly hospitals and public health units respond to the epidemic. implications of our study for primary health care in developing countries: endemic and epidemic infectious diseases inflict high levels of morbidity and mortality in developing countries because of a combination of poor living conditions, effects of multiple concurrent illnesses particularly in children, fragile national health systems, overburdened and overstressed health workers, and negative work environments [ ] . although our study targeted general practice in developed countries, the conceptual framework we developed (table ) can be used by primary health care services in developing countries to deconstruct the multidimensional challenges posed by pandemic influenza. identifying possible solutions and apportioning responsibilities across components of the health system is more complex. operational guidelines have been developed for the detection and rapid containment of a potentially pandemic strain of influenza to the epicentre of the outbreak [ ] , for example, if this were to occur in a south east asian country. however, because of the immense global implications of such an event, this intensive strategy will need to be supported by extraordinary resources from the global community, an action not sustainable once the pandemic strain spreads beyond the initial epicentre. in an analysis of pandemic influenza plans in asia-pacific countries in , coker found that although all countries recognised the importance of pandemic planning, operational responsibility particularly at the local level, remained unclear; most plans relied on specialised flu hospitals, while few developed the possibility of caring for patients at home [ ] . (the study made no reference to primary health care or the private practice sector). in his analysis of public health emergencies in developing countries, quarantelli identified relatively poor adaptive capabilities to be the key barrier to effective responses at the central and local levels [ ] . possible reasons included poorer public health infrastructures and human and financial resources, organisational structures that functioned mainly in a top-down manner with a strong emphasis on structures more than functions, and lack of planning initiatives the further away one moved from central level [ ] . many poor countries already have a health crisis, and need massive international investments, including mobilisation and strengthening of human resources to build sustainable health systems, strong leadership and political commitment [ ] . in the face of the pandemic threat, primary health care in developing countries will need resources to develop a suite of policies, including: clarification of what essential primary health care will continue through a pandemic, developing health workforce plans that may entail diverting clinicians from other areas of the health workforce, establishing non-hierarchical links between primary health care, hospitals and public health, and injecting funds into hospital and primary care preparedness simultaneously. it may be argued that the absence of general practice elements from pandemic plans is not problematic, that it is outside the responsibility of public health departments that do not have a governance role for general practice. we argue instead that the general practice sector, which is characterised by loose networks between ambulatory care services, and often lacks the appropriate organisational structure and mandate, cannot spearhead many elements of planning for primary care. this calls for actions by health departments as well as by general practices. actions by health departments. ensuring that the community receives appropriate health care during public health emergencies is a government responsibility. consequently, health departments must emphasise in national and sub-national plans, the critical need for all levels of the health system to integrate the general practice sector in the planning process. this should include appropriate general practice representation in high level planning and decision-making committees, in incident-commandcontrol structures and in the management of community-based specialised clinics such as 'fever clinics' or 'community information and assessment centres'. good planning must focus on the planning process rather than the production of a written document [ ] . the process includes collaborative activities such as meetings, drills, exercises, simulations, developing techniques for training, knowledge transfer, identifying and obtaining resource materials, and continually updating materials and strategies. these planning activities are important not only because they inform, but because they also foster collaborative learning and problem-solving, and generate an atmosphere of mutual trust and solidarity among people who will be affected by a pandemic and whose collaboration will be essential in the response. the willing general practitioner sector [ , ] is an essential resource for extending the surge capacity of health departments. health departments should harness and support interactions and networking among general practices, and between them and ambulatory health care providers, hospitals and public health units. the role of general practice in contact tracing, monitoring and treating people in home isolation or quarantine, dispensing antiviral drugs and participating in mass vaccinations -omitted in most plans -needs to be clarified. in addition, health departments should modify or adopt where appropriate, legislation and financing mechanisms to enable general practices to function optimally during the pandemic. action to support planning by general practice. while the diversity of the general practice sector means that there will not be guidelines to cover all scenarios and contexts, a coherent approach would enable multi-actor accountability and more efficient, contextual planning by jurisdictions. the guidelines for pcts [ ] are an example of such an approach, designed for a particular health system. they could act as a useful point of departure for planning integrated general practice plans by other health systems. there is a need for a system of sharing innovations and exemplary solutions to challenges for pandemic planning by general practice, analogous to those targeting mainly hospitals and public health departments [ ] . given the diversity in organisation of general practice systems, a web presence comparing exemplary approaches from different health systems would be a useful resource for planners. an important challenge will be ensuring collaboration and coordination across the health sector during a pandemic. research is needed to identify the prevailing barriers and facilitators to effective collaboration across the health sector, how these may change under the stressor of a pandemic, and how this information could be used to optimise the response. the regulatory environment is founded on a set of ethical principles, often unarticulated. since there is likely to be some dispute between utilitarian philosophical approaches used in public health and deontological or virtue ethical approaches used in clinical medicine [ ] , there is a need for some preparatory work with general practitioners clarifying ethics of clinical behaviour, restriction of liberty under quarantine orders, and resource allocation and distribution. in an established pandemic, it is likely that there will be shortfalls in the gp workforce, due to illness among gps, caring duties or closure of small practices. non-hospital clinical specialists, retired general practitioners, allied health professionals and medical students could be trained to fill the gap in services. research is needed to define the clinical work that can be done by other health personnel in general practice, eligibility criteria and accreditation processes for this cadre of workers, and optimal training processes. all public health problems have a clinical dimension, and all clinical problems have a public health dimension. at present, the plans in the five countries provide more detail on the public health dimension of the pandemic. there are intercountry differences in the emphases provided to different domains of the general practice response. some of this reflects the emphasis on particular elements contained within the relevant national plan. some of the differences are due to the ways in which general practice is structured in a country, and the strengths of its linkages to other components of the health sector. there is an urgent need to incorporate general practice and the broader primary care sector into pandemic planning activities, and to undertake the preparedness activities that would make this sector, which provides the majority of health care work, a true partner in pandemic response. figure s jurisdictions or health management organizations whose plans were included in the study. found at: doi: . /journal.pone. .s ( . mb doc) outbreak of severe acute respiratory syndrome in hong kong special administrative region: case report a study on sars awareness and health-seeking behaviour -findings from a sampled population attending national healthcare group polyclinics assessing the burden of influenza and other respiratory infections in england and wales public health preparedness: a systems-level approach assessing public health emergency preparedness: concepts, tools, and challenges quality improvement in public health emergency preparedness enhancing public health response to respiratory epidemics: are family physicians ready and willing to help? the gp's response to pandemic 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science: the challenge of complexity in health care preparing for an influenza pandemic: ethical issues national pandemic influenza exercise: exercise cumpston report exercise winter willow -lessons identified roundup: exercise promotes singapore's preparedness for flu pandemic human resources for health: overcoming the crisis interim protocol: rapid operations to contain the initial emergence of pandemic influenza pandemic influenza preparedness in the asia-pacific region quarantelli e major criteria for judging disaster planning and managing and their applicability in developing societies promising practices: pandemic preparedness tools raising the profile of public health ethics in australia: time for debate we are grateful to our colleagues from general practices, public health units and general practice organizations who have contributed to this study, and to ms sally hall, ms marianne shearer, ms hannah walker, dr jonathon anderson, dr ron mccoy, dr chris hogan, dr kathryn antioch, and ms monika thompson. key: cord- -luqvw y authors: levinson, julia; kohl, kid; baltag, valentina; ross, david title: investigating the effectiveness of school health services delivered by a health provider: a systematic review of systematic reviews date: - - journal: biorxiv doi: . / sha: doc_id: cord_uid: luqvw y schools are the only institution regularly reaching the majority of school-age children and adolescents across the globe. although at least countries have school health services, there is no rigorous, evidence-based guidance on which school health services are effective and should be implemented in schools. to investigate the effectiveness of school health services for improving the health of school-age children and adolescents, a systematic review of systematic reviews (overview) was conducted. five databases were searched through june . systematic reviews of intervention studies that evaluated school-based or school-linked health services delivered by a health provider were included. review quality was assessed using a modified ballard and montgomery four-item checklist. references were screened and systematic reviews containing primary studies were assessed narratively. interventions with evidence for effectiveness addressed autism, depression, anxiety, obesity, dental caries, visual acuity, asthma, and sleep. no review evaluated the effectiveness of a multi-component school health services intervention addressing multiple health areas. strongest evidence supports implementation of anxiety prevention programs, indicated asthma education, and vision screening with provision of free spectacles. additional systematic reviews are needed that analyze the effectiveness of comprehensive school health services, and specific services for under-researched health areas relevant for this population. and should be implemented in schools. to investigate the effectiveness of school health services for improving the health of school-age children and adolescents, a systematic review of systematic reviews (overview) was conducted. five databases were searched through june . systematic reviews of intervention studies that evaluated school-based or school-linked health services delivered by a health provider were included. review quality was assessed using a modified ballard and montgomery four-item checklist. references were screened and systematic reviews containing primary studies were assessed narratively. interventions with evidence for effectiveness addressed autism, depression, anxiety, obesity, dental caries, visual acuity, asthma, and sleep. no review evaluated the effectiveness of a multi-component school health services intervention addressing multiple health areas. strongest evidence supports implementation of anxiety prevention programs, indicated asthma education, and vision screening with provision of free spectacles. additional systematic reviews are needed that analyze the effectiveness of comprehensive school health services, and specific services for under-researched health areas relevant for this population. the world health organization (who) launched the global school health initiative in with the goal to improve child, adolescent and community health through health promotion and programming in schools [ ] . this initiative is dedicated to promoting development of school health programs and increasing the number of health-promoting schools, characterized by who as "a school constantly strengthening its capacity as a healthy setting for living, learning and working" [ ] . in , who, the united nations educational, scientific and cultural organization (unesco), the united nations children's fund (unicef) and the world bank developed a partnership for focusing resources on effective school health -a fresh start approach [ ] . the fresh framework promotes four pillars: health-related school policies, provision of safe water and sanitation, skills-based health education and school-based health and nutrition services [ ] . while various guidance documents have been published by united nations (un) organizations addressing a range of services from oral health to malaria [ ] [ ] [ ] [ ] [ ] , there is no internationally accepted guideline regarding school health services. this systematic review of systematic reviews, henceforth referred to as an overview, will inform the upcoming development of a who guideline that addresses one pillar of the fresh framework: school health services delivered by a health provider. schools offer a unique platform for health care delivery. in , the global means for the primary and secondary net school enrollment rates were % and %, respectively, thus the potential reach of school health services is wide [ ] . additionally, a recent review found that school-based or school-linked health services already exist in at least countries [ ] . the global accelerated action for the health of adolescents (aa-ha!) implementation guidance calls for the prioritization of school health programs as an important step towards universal health coverage and urges that "every school should be a health promoting school" [ ] . the primary objective of this overview was to explore the effectiveness of school- based or school-linked health services delivered by a health provider for improving the health of school-age children and adolescents. through a comprehensive literature search, the overview aimed to identify health areas and specific school health service interventions that have at least some evidence of effectiveness. it was also designed to suggest further research in areas where recent systematic reviews (srs) exist, but with insufficient evidence. finally, the overview aimed to identify the health areas and specific school health services interventions for which no srs were found, whether because the primary literature does not exist or where there are primary studies but no sr has been conducted. this overview was conducted using the preferred reporting items for systematic reviews and meta-analyses (prisma) [ ] . a protocol was developed a priori that outlined the overview objectives, aims, operational definitions, search strategy, inclusion/exclusion criteria, and quality appraisal methods. this document was followed throughout the review process and is available in s appendix. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] enrolled in schools; (b) interventions were school-based or school-linked health services, involved a health provider (see definitions in s appendix), and were of any duration or length of follow-up; (c) intervention effectiveness was compared to either no intervention, an alternative intervention, the same intervention in a different setting (i.e. not in schools), an active control, or a waitlist control; (d) interventions aimed to improve some aspect of health; and (e) study designs were either randomized controlled trials (rcts), quasi-experimental studies (qes), or other non-randomized intervention studies. there were no date restrictions on publication of included srs. in addition to these criteria for included studies, the srs themselves had to fulfill the following criteria: (a) included the words "systematic review" in the title or abstract; (b) outlined inclusion criteria within the methods section; (c) published in peer-reviewed journals and indexed before june , ; (d) published in the english language. in addition to srs that did not meet these inclusion criteria, srs were excluded if the review was superseded by a newer version. study selection citations identified from the systematic search were uploaded to covidence systematic review software [ ] and duplicates were automatically deleted. two reviewers (kk and jl) screened all titles and abstracts using the inclusion/exclusion criteria and excluded all articles that were definitely ineligible. articles that received conflicting votes (ineligible vs. potentially or probably eligible) were discussed and consensus was reached. the same two reviewers screened the full text of all the potentially or probably eligible articles using a ranked list of the inclusion criteria (s appendix). reasons for exclusion were selected from the ranked list. if consensus was not possible during title/abstract or full text screening, a third reviewer (dr), who had the casting vote, would have been asked to independently screen the article. this was never required as consensus was always reached. data collection one reviewer (jl) extracted summary data from each selected article using a customized standard form with independent data extraction performed for % of included srs by one of the other reviewers (dr or kk). there was % agreement between reviewers for all items within the standard form, with discrepancies only in level of detail . data items included the research design of the sr and primary studies, sample description and setting, intervention characteristics, outcomes, meta-analysis results, quality appraisal, and conclusions. due to the heterogeneity of the srs included in this overview, it was not possible to perform a meta-analysis. outcome measures were collected from included studies. risk of bias within primary studies was recorded in s appendix. risk of bias across srs was determined using ballard and montgomery's four-item checklist for overviews of srs [ ] . these items include: ( ) overlap (see below), ( ) rating of confidence from the amstar checklist [ ] , ( ) date of publication, and ( ) match between the scope of the included srs and the overview itself. an important consideration in overviews is the degree of overlap, or the use of the same primary study in multiple included srs. high overlap can contribute to biased results [ ] . this overview used the corrected covered area (cca), a comprehensive and validated measure, to determine overlap [ ] . the cca is calculated using three variables: the number of "index" publications (r), the number of total publications (n), and the number of srs within the overview (c). an "index" publication is the first appearance of a primary study within an overview. the formula for the cca is: ccas can be interpreted as indicating slight, moderate, high or very high overlap with scores of - , - , - , or > , respectively [ ] . the amstar checklist [ ] was used to appraise quality of included srs. one reviewer (jl) assessed all srs and a second (kk) duplicated appraisal of %, with % agreement and only minor disagreements that did not impact grades of confidence. following the recommendation of the amstar developers [ ] , individual ratings were not combined into an overall score. instead, the authors determined which of the items on the checklist were critical for this overview and which of the items were non-critical. building on a method suggested by shea and colleagues [ ] , grades of confidence in the results of each sr were generated based on critical flaws and non-critical weaknesses. the grading system is available in s appendix. confidence in results ranged from high (three or fewer non-critical weaknesses) to critically low (more than three critical flaws with or without non-critical weaknesses) [ ] . used meta-analysis to combine results [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , whereas the remaining nine srs narratively synthesized results [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . eleven srs included studies located in countries with high- income or upper-middle income economies only [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , , ] . six srs included at least one study from countries with lower-middle income or lower income economies [ , , , , , ] . the final three srs either did not state the locations of included studies [ , ] or provided regions rather than specific country locations [ ] . to be included in this overview, at least % of studies within each sr had to fulfill all inclusion criteria. in four srs, % of included studies fulfilled all inclusion criteria [ , , , ] , although brendel and colleagues [ ] only included one study in total. in another four srs, % to % of included studies fulfilled all the inclusion criteria [ , , , ] . in the remaining twelve srs, % to % of included studies fulfilled all the inclusion criteria [ , , [ ] [ ] [ ] [ ] , , , [ ] [ ] [ ] . all srs primarily examined studies on school-based, rather than school-linked interventions. the srs covered eight health areas: nine on mental health [ , , , , , [ ] [ ] [ ] ] , four on oral health [ , , , ] , two on asthma [ , ] , and one sr each on sleep [ ] ; obesity [ ] ; vision [ ] ; menstrual management [ ] ; and sexual and reproductive health (srh) [ ] . eleven srs included only cluster-and individually- randomized controlled trials [ ] [ ] [ ] , , , , , , ] , seven srs included other types of controlled and uncontrolled experimental studies in addition to rcts [ , , , , , , ] , and two srs included only qes [ ] or controlled clinical trials [ ] . table the corrected covered area (cca) was found to be , indicating only slight overlap between the srs. calculations for the cca can be found in s appendix. table presents the remaining three of the four items of ballard and montgomery's checklist for overviews of reviews: ( ) levels of confidence in results for each included sr, ( ) publication year, and ( ) match in scope to the overview. a majority of the studies ( %) were given low or critically low levels of confidence. only three srs [ , , ] were scored as having moderate levels of confidence and just one [ ] was given a high level of confidence. the details of the quality appraisal of primary studies included in the srs are given in s appendix. [ ] oral health moderate % bastounis [ ] mental health low % brendel [ ] mental health critically low % chung [ ] sleep low % cooper [ ] oral health high % evans [ ] vision moderate % geryk [ ] asthma critically low % gold [ ] mental [ ] obesity critically low % stein [ ] oral health low % sullivan [ ] mental health critically low % walter [ ] asthma low % werner-seidler [ ] mental health low % a the four items of the checklist include: overlap, amstar rating of confidence, up-to-date, and relevance of included studies b see s appendix for amstar rating information c i.e., percentage of studies within the systematic review that clearly fulfill all inclusion criteria srh = sexual and reproductive health none of the srs evaluated comprehensive, multi-component, or multi-health area school health services. two srs found strong evidence for the potential effectiveness of educational interventions for children and adolescents with asthma diagnoses (table a) [ , ] . geryk and colleagues found that education on correct use of an inhaler improved inhaler technique, regardless of deliverer, method, or duration of the intervention [ ] . however, they did not assess risk of bias or appraise the quality of included studies [ ] . walter and colleagues found that family asthma educational programs for children and their parents or caregivers improved quality of life for both caregivers and children, and decreased asthma exacerbations for children [ ] . while results from primary studies were statistically significant in both srs, heterogeneity of interventions precluded meta-analysis by walter and colleagues [ ] and no reason was given for why meta-analysis was not performed by geryk and colleagues [ ] . hennegan and montgomery assessed the effectiveness of "hardware" and "software" menstrual management interventions (table b ) [ ] . hardware interventions included provision of sanitary products and software interventions focused on menstrual management education. a metaanalysis of two studies on sanitary pad provision found a moderate but statistically non-significant effect on school attendance. however, it was unclear whether these studies involved a health provider [ ] . outcomes across studies differed, but the authors noted trends toward improvement in menstruation knowledge, management practices, psychosocial outcomes, and school attendance. hennegan and montgomery found a high level of heterogeneity and substantial risk of bias in the included studies overall, thus they were unable to make conclusions about the effectiveness of menstrual management interventions [ ] . the effectiveness of school-based mental health services was assessed in nine srs (table c ) [ , , , , , [ ] [ ] [ ] , ] . srs addressed various intervention types: universal interventions [ , , , , , ] ; targeted interventions for military-connected children [ ] , children and adolescents at risk for depression and/or anxiety [ , ] , refugee and war-traumatized youth [ ] , and children referred to therapy [ ] ; and indicated interventions for children and/or adolescents diagnosed with autism spectrum disorder [ ] , depression [ , , ] , or anxiety [ , , ] . prevention and treatment of mood disorders was assessed in five srs, all of which targeted children and adolescents using rcts of established programs. higgins and o'sullivan assessed the friends for life program, a manual-based cognitive behavioral anxiety prevention program comprised of ten sessions with developmentally-tailored programs for different age groups [ ] . they found statistically significant improvements in self-reported measures of anxiety for participants who completed the program as compared to those in the control group [ ] . a sr and meta-analysis by bastounis and colleagues on the educational and preventative penn resiliency program (prp) and its derivatives found small, non-significant effect sizes for the prevalence of both depression and anxiety, favoring the intervention in the former and the control in the latter [ ] . the remaining three srs also assessed friends and prp along with additional often-overlapping programs. neil and christensen analyzed unique anxiety prevention and early intervention programs and found reductions in anxiety symptoms in % of the included studies [ ] . kavanagh and colleagues examined depression and anxiety group counseling programs based on cognitive behavioral therapy (cbt) and found statistically significant reductions of depressive symptoms at both four weeks and three months follow-up [ , ] . finally, meta-analysis by werner-seidler and colleagues of rcts on the effectiveness of depression and anxiety prevention and group therapy programs found small yet statistically significant effect sizes in favor of the intervention groups for both depression and anxiety as compared to control groups [ ] . although the overall degree of overlap between all srs within this overview was slight, the overlap between just these five srs targeting mood disorders was high (cca = ). assessments of music [ ] and art therapy [ ] in two srs reported weak evidence of effectiveness. gold and colleagues assessed daily music therapy as an intervention to improve verbal and gestural communicative skills and reduce behavioral problems in children diagnosed with autism spectrum disorder [ ] . meta-analysis found small but statistically significant effect sizes in favor of music therapy for gestural communication, verbal communication, and behavioral problems [ ] . oppositional defiant disorder (odd), separation anxiety disorder (sad), moderate to severe behavior problems, or learning disorders [ ] . the authors found improvements in classroom behavior, symptoms of odd, and symptoms of sad [ ] . however, in the studies included in both gold and colleagues' and mcdonald and drey's srs, the numbers of participants per intervention group were very small: - and - per study, respectively, introducing possibility of bias [ , ] . mostly favorable evidence of effectiveness was found in a sr of social-emotional interventions for refugee and war-traumatized youth from countries [ ] . improvements in trauma-related symptoms and impairment were found through narrative assessment of creative expression interventions, cognitive behavioral interventions, and multifaceted interventions [ ] . in contrast with gold and colleagues [ ] , this sr by sullivan and simonson found negative effects from music therapy interventions [ ] . however, there was no risk of bias assessment in this sr and therefore the results must be interpreted cautiously. the final sr on mental health services examined well-being interventions for children with a parent in the military [ ] . only one quasi-experimental study from the united states in was included in the sr. the study assessed a group counseling intervention and found no statistically significant effects on the prevalence of anxiety, self-esteem, internalizing behavior or externalizing behavior [ ] . schroeder and colleagues reviewed the effectiveness of obesity treatment and prevention interventions that specifically involved a school nurse (table d ) [ ] . most interventions involved school-nurse-delivered nutrition counseling, nutrition and health education, and some parent involvement or physical activity. meta-analysis indicated small, yet statistically significant, reductions in body mass index (bmi), bmi z-score, and bmi percentile for both obesity treatment and prevention [ ] . srs on oral health interventions focused on prevention [ , ] , screening [ ] , and education [ , ] (table e ). strongest evidence in favor of oral health interventions emerged from a sr on universal topical application of fluoride gel for the prevention of dental caries [ ] . meta-analysis results indicated a statistically significant effect on the before-after change in caries prevalence [ ] . a universal educational intervention on oral hygiene and caries produced weaker evidence of effectiveness [ ] . small but statistically significant effect sizes were found in favor of the intervention for mean plaque levels and oral hygiene, but no statistical significance was found for change in gingivitis indices [ ] . two srs on dental health screening [ ] and behavioral interventions for caries prevention [ ] found limited evidence of effectiveness. arora and colleagues did not find any rcts that looked at the effectiveness of dental health screening versus no screening on improving oral health outcomes, but their search did locate six rcts from the united kingdom and india with dental care attendance as the outcome [ ] . the data was too heterogeneous to meta-analyze, and the authors determined that the certainty of the evidence of the benefit of dental screening in increasing dental attendance was very low [ ] . the other sr examined behavioral interventions in the form of education on tooth brushing and the use of fluoride toothpaste in brazil, italy, united kingdom, and iran [ ] . due to the diversity in outcome measures and intervention intensities, the authors felt unable to make any evidence-based recommendations [ ] . a sr on sexual health interventions for prevention of sexually transmitted infections (stis) and human immunodeficiency virus (hiv) in sub-saharan african countries found that educational interventions were successful in increasing knowledge and attitudes for participants (table f ) [ ] . however, the sr suggested that the studies were ineffective in changing self-reported risky behaviors, although follow-up was either immediate or short-term (less than months) [ ] . this sr did not discuss the quality or risk of bias of included studies [ ] . chung and colleagues systematically reviewed and meta-analyzed universal sleep education programs as compared to no additional sleep intervention from australia, new zealand, brazil, and hong kong (table g ) [ ] . five of the included studies examined the same weekly sleep education program from the australian centre for education in sleep. the sixth study assessed a -day program in brazil. meta-analysis of the six studies showed statistically significant short-term benefits for weekday sleep time, weekend sleep time, and mood [ ] . however, these results did not persist at follow-up [ ] . evans and colleagues reviewed seven rcts from china, india, and tanzania on vision screening for correctable visual acuity deficits at or before school entry (table h ) [ ] . through meta-analysis of two rcts, the authors found that school vision screening combined with provision of free spectacles resulted in a statistically significant % increase in the wearing of spectacles at - months follow-up as compared to vision screening combined with prescription for spectacles only [ ] . evans and colleagues found no statistically significant difference in the proportion of students wearing spectacles at - months follow-up between vision screening with provision of ready-made spectacles and vision screening with provision of custom-made spectacles in a meta-analysis of three rcts [ ] . education on the wearing of spectacles in addition to vision screening as compared to vision screening alone did not have a significant effect [ ] . no srs found eligible studies comparing vision screening with no vision screening. this overview found srs covering primary studies. the majority of srs assessed educational, counseling, or preventive interventions, most of which were special research interventions rather than routinely-delivered school health services. no sr examined comprehensive or multi-component school health services, despite the fact that comprehensive services may be more efficient, easier to implement, and more sustainable than single interventions [ ] . results from this overview suggest that certain interventions can be effective in improving child and adolescent health outcomes, and thus may be worthwhile for integration into school health programs. vision screening is one of the most common forms of school health services [ ] , although the majority of programs are concentrated in high-income countries (hic) [ ] . although prevalence of visual impairment varies widely by ethnic group and age [ ] , who estimates that at least million children below age are visually impaired [ ] . evans and colleagues found strong evidence from china, tanzania, and india that school vision screening for correctable visual acuity deficits increased wearing of spectacles when spectacles were provided at no cost [ ] . a recent guideline from the international agency for prevention of blindness (iapb) reiterates the importance of free spectacles and goes further to suggest that low-and middle-income countries (lmic) adopt comprehensive school eye health programs [ ] . vision screening linked with free provision of spectacles, as a component of a comprehensive school eye health program, is an example of a cost-effective form of school health services that may be implemented. five srs covered depression and/or anxiety prevention and early intervention programs, with the friends for life program (friends) and the penn resiliency program (prp) most common [ , , , , ] . given that friends has been endorsed by who [ ] and was found to be effective in decreasing anxiety symptoms in all four srs where it was mentioned in this overview [ , , , ] , policy makers and school health officials may consider incorporating this or similar programs into existing school health services. the four srs that included prp found mixed evidence [ ] or no evidence of effectiveness [ , , , ] , bringing the popularity of this intervention into question. finally, creative therapy interventions seem to be effective for indicated populations of school-age children, such as children with autism spectrum disorder [ , ] . however, this conclusion should be interpreted cautiously due to small effect sizes, small sample sizes, and conflicting evidence on the effectiveness of music therapy between sullivan and simonson [ ] and gold and colleagues [ ] . comprehensive school programs that promote healthy school environments, health and nutrition literacy, and physical activity are one of the six key areas for ending childhood obesity recommended by who [ ] . this overview found only one sr that assessed obesity treatment and prevention delivered by a health professional in schools, despite the fact that over million school-age children and adolescents were overweight or obese in [ ] . schroeder and colleagues found that school nurses are well positioned to deliver nutritional counseling, design and coordinate physical activity interventions, and educate parents, students, and staff on health, nutrition, and fitness [ ] . however, all included primary studies were delivered in hic [ ] . schools are considered to be an ideal platform for oral health promotion through education, services, and the school environment [ ] . the most promising evidence from a sr was on topical application of fluoride gel for the prevention of dental caries [ ] . educational interventions had mixed effects. a sr that focused on behavioral education, such as demonstrating how to correctly brush teeth, found no evidence for reduction in caries [ ] , whereas a sr on oral hygiene and caries education found evidence for decreased plaque and improved hygiene [ ] . more research should be done to identify the content and methods of deliver that make some oral health education interventions more effective than others. it is difficult to determine overall effectiveness of school health services from this overview because the included srs do not sufficiently cover the health areas most relevant for children and adolescents. in , the top five leading causes of death for - year olds were lower respiratory infections, diarrheal diseases, meningitis, drowning, and road injury [ ] . among - year olds, the leading causes of death were lower respiratory infections, drowning, road injury, diarrheal diseases, and meningitis [ ] . finally, for [ ] [ ] [ ] [ ] [ ] year olds, the leading causes of death were road injury, self-harm, interpersonal violence, diarrheal diseases, and lower respiratory infections [ ] . leading causes of disability-adjusted life years (dalys) for - year olds were iron deficiency anemia, road injury, depressive disorders, lower respiratory infections, and diarrheal diseases [ ] . this overview shows that the current sr literature does address mental health, specifically mood disorders. however, the causes of death and disability beyond self-harm and depressive disorders are currently not addressed. although mortality and morbidity statistics vary by region and country, it is clear that the health areas included in this overview reflect a small subset of the global burden of disease for children and adolescents. furthermore, this overview exposes a mismatch between the sr literature on effectiveness of school health services and the actual school health services that are most commonly delivered. vaccinations have been identified as the most common type of intervention in schools in at least countries or territories [ ] , and there is evidence of effectiveness from primary studies regarding feasibility of school-based vaccination programs [ , ] . yet no srs on vaccinations fulfilled the inclusion criteria for this overview, suggesting the need for these srs to be conducted. additionally, at least countries or territories include some form of school health services that are routinely delivered, as opposed to special research interventions [ ] . this overview primarily found evidence for special research interventions, suggesting a need for assessment of routinely-delivered school health services. one of the central questions of this overview was whether the school health services that are regularly delivered across the globe are evidence-based. the mismatch in the sr literature identified by this overview demonstrates that more research must be done before an answer to this question can be determined. another important gap that this overview reveals is a lack of research on interventions carried out in lmic and low-income countries (lic). only one of the srs included in this overview examined studies from a majority of lmic and lic [ , ] . this is problematic given that health disparities for children and adolescents are greater in lmic and lic than in higher income countries [ ] . additionally, resources differ by income level and therefore effective interventions in hic may need to be tailored or changed entirely in order to be feasible in lmic and lic. who reports densities of less than one physician per population in countries and less than three nurses or although three srs mentioned the cost of specialized professionals delivering interventions versus teachers or a school nurse [ , , ] , cost, let alone cost-effectiveness, was not closely analyzed in any of the included srs. for useful recommendations to be made regarding school health services, cost-effectiveness must be more closely examined by primary studies and srs. although overviews offer a comprehensive method for synthesizing evidence, they also come with important methodological limitations. first, an overview is unlikely to include the latest evidence if recent primary studies have not yet been included in srs. this lag may preclude the ability for an overview to truly reflect current knowledge [ ] . while this overview found significant gaps in the evidence for certain health areas, this does not necessarily mean that relevant high quality primary trials have not been conducted. second, the ability of overviews to make valid and accurate conclusions is dependent upon the accuracy, rigor, and inclusiveness of the srs themselves. % (n= ) of srs included in this overview were given ratings of low or critically low confidence using the amstar checklist, although this is not unusual given the stringency of the checklist. nonetheless, it is interesting to note that all four of the srs given moderate or high levels of confidence were cochrane reviews. the remaining cochrane review was given a critically low level of confidence, though this may be because it was published in and standards for both the methods and reporting of cochrane reviews have improved in recent years. third, the scopes of individual srs often differ from the scope of the overview, a problem that ballard and montgomery call a "scope mismatch" [ ] . in this overview, srs with at least % of included studies fulfilling all criteria were included after extensive discussion between the authors and experts in the field. this implies that a narrower range of srs would have been eligible if a stricter cut-off had been selected, and vice versa. it is important to take this into account when interpreting results. finally, overlap of primary trials between srs can bias results of an overview [ ] . there is no definitive guidance on how to correct for overlap, as both including or excluding overlapping srs presents potentially biased results [ , ] . this overview measured overlap using the corrected covered area (cca) [ ] and did not exclude overlapping studies. however, the degree of overlap across all srs was graded as being small (cca = ), while there was high overlap in srs on mood disorders (cca = ). cca values for all health areas and calculations are available in s appendix. a key limitation of this overview is that only publications self-titled "systematic reviews" were included. this decision was made because of the vast numbers of reviews available and the increased rigor associated with the term "systematic". a sensitivity analysis comparing "systematic*" with "systematic review" found that the number of search results increased almost three-fold, but did not reveal any new articles that would eventually have met the subsequent eligibility criteria. another limitation is that this overview only included randomized and non-randomized controlled trials, quasi-experimental studies and other controlled study designs where health professionals delivered the intervention. while this strengthens the rigor of included studies and improves decision-making ability, it also excludes potentially relevant literature. a strength of this overview is that it attempted to answer a question that has not yet been answered regarding the effectiveness of both comprehensive and specific school health services delivered by a health provider. while other pillars of health promoting schools have relevant guidance documents, guidance on school health services is limited and not explicitly evidence-based. given the wide reach of schools and the fact that school health services already exist in most countries, international guidelines are needed to clarify whether school health services can be effective, and if so, which interventions should and should not be included. this overview makes an important first step toward that guideline. this overview presents multiple effective interventions that may be offered as a part of school health services delivered by a health provider. however, it is difficult to formulate an overarching answer about the effectiveness of school health services for improving the health of school-age children and adolescents due to the heterogeneity of srs found and the evident gaps in the sr literature. more than half of included srs analyzed mental health and oral health interventions, and no srs were found that assessed other relevant health areas, such as vaccinations, communicable diseases, injuries, etc. further, no srs evaluated comprehensive or multi-component school health services. if school health services are to truly improve the health of children and adolescents, they must comprehensively address the most pressing problems of this population. in order for policy makers and leaders in school health to make evidence-based recommendations on which services should be available in schools, who should deliver them, and how should they be delivered, more srs must be done. these srs must assess routine, multi-component school health services and the characteristics that make them effective, with special attention to content, quality, intensity, method of delivery, and cost. the gaps in the sr literature identified by this overview will inform the commissioning of new srs by who to feed into evidence-based global recommendations. who | global school health initiative focusing resources on effective school health: a fresh start to enhancing the quality and equity of education who information series on school health: oral health promotion: an essential element of a health-promoting school. geneva: world health organization school-based deworming: a planner's guide to proposal development for national school-based deworming programs deworm the world basic guide for school directors, teachers, students, parents and administrators usaid hygiene improvement project malaria control in schools: a toolkit on effective education sector responses to malaria in africa world bank open data global overview of school health services: data from countries world health organization. global accelerated action for the health of adolescents (aa-ha!): guidance to support country implementation preferred reporting items for systematic reviews and meta-analyses: the prisma statement covidence systematic review software veritas health innovation risk of bias in overviews of reviews: a scoping review of methodological guidance and four-item checklist amstar : a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. the bmj overviews of systematic reviews: great promise, greater challenge systematic review finds overlapping reviews were not mentioned in every other overview amstar : a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both school dental screening programmes for oral health. the cochrane library the effectiveness of the penn resiliency programme (prp) and its adapted versions in reducing depression and anxiety and improving explanatory style: a systematic review and meta-analysis school-based sleep education programs for short sleep duration in adolescents: a systematic review and meta-analysis vision screening for correctable visual acuity deficits in school-age children and adolescents. the cochrane library do menstrual hygiene management interventions improve education and psychosocial outcomes for women and girls in low and middle income countries? a systematic review music therapy for autistic spectrum disorder. the cochrane library school-based cognitivebehavioural interventions: a systematic review of effects and inequalities fluoride gels for preventing dental caries in children and adolescents. the cochrane library are school nurses an overlooked resource in reducing childhood obesity? a systematic review and meta-analysis effectiveness of oral health education on oral hygiene and dental caries in schoolchildren: systematic review and meta-analysis school-based depression and anxiety prevention programs for young people: a systematic review and meta-analysis effects of school-based interventions with u.s. military-connected children: a systematic review primary school-based behavioural interventions for preventing caries a systematic review of school-based interventions that include inhaler technique education what works": systematic review of the "friends for life" programme as a universal school-based intervention programme for the prevention of child and youth anxiety primary-school-based art therapy: a review of controlled studies efficacy and effectiveness of school-based prevention and early intervention programs for anxiety a systematic review of school-based sexual health interventions to prevent sti/hiv in sub-saharan africa a systematic review of school-based social-emotional interventions for refugee and war-traumatized youth effectiveness of school-based family asthma educational programs in quality of life and asthma exacerbations in asthmatic children aged five to : a systematic review world bank country and lending groups -world bank data help desk school-based cognitivebehavioural interventions: a systematic review of effects and inequalities global variations and time trends in the prevalence of childhood myopia, a systematic review and quantitative meta-analysis: implications for aetiology and early prevention vision impairment and blindness. in: world health organization standard school eye health guidelines for low and middle-income countries the international agency for the prevention of blindness prevention of mental disorders: effective interventions and policy options geneva: world health organization obesity and overweight. in: world health organization who [internet human papillomavirus vaccination in tanzanian schoolgirls: cluster-randomized trial comparing vaccine-delivery strategies feasibility of delivering hpv vaccine to girls aged to years in uganda world health statistics : monitoring health for the sdgs, sustainable development goals. geneva: world health organization ensure healthy lives and promote wellbeing for all at all ages we would like to thank tomas allen for his guidance and support in designing the search strategy. we are also grateful for advice from the who school health services guideline steering group and guideline development group members. key: cord- - uu dh authors: ford, lea berrang title: climate change and health in canada date: - - journal: mcgill j med doi: nan sha: doc_id: cord_uid: uu dh nan national governments from around the world met in poznan, poland in december at the th conference of the parties to the united nations framework convention on climate change ( ). this conference came at a time of increasing political and scientific confidence in the role of human-induced greenhouse gas emissions in changing global temperatures. the most recent ( ) report of the intergovernmental panel on climate change ( ) states that climate change is now "unequivocal", based on increasing evidence from global average air and ocean temperatures, melting of snow and ice, and rising global average sea level" ( ) . while there remains uncertainty regarding the specific nature and rate of climatic changes and their impacts, there is negligible scientific doubt that the global climate is changing and that these changes will have significant and potentially profound impacts on a wide range of ecological and human systems across the planet ( ) ( ) ( ) ( ) . that climate change predictions are both scientifically and politically daunting lessens neither their verity nor implied imperative ( , ) . climate change will involve an average increase in global temperatures of approximately . - . °c by the end of the century ( ); this range reflects both uncertainty in climate modeling, as well as a range of possible scenarios for how we will respond to climate changes, including mitigation, technology development, economic development and population growth. this temperature shift will be manifest in average global climatic changes, including higher maximum temperature, more very hot days, increased occurrence and severity of heat waves, fewer cold and frost days, fewer cold spells, more intense precipitation events, increased risk of drought in continental areas, increased cyclone intensities, and intensified enso events. these effects will, however, vary significantly by region and act within existing climate conditions. for example, while parts of latin america will see minimal changes in temperature, arctic regions are expected to experience an average temperature shift of - °c by the end of the century ( ) and recent research suggests that even these projections may be conservative ( , ) . changes in our global and regional climate systems will have important implications for health and health systems ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the world health organization estimated that in the year , climate change caused approximately , excess deaths worldwide, as well as million disability-adjusted life years ( ) . temperature and weather have direct effects on mortality and morbidity through the occurrence of extreme weather events, including heatwaves, cold periods, storms, floods, and droughts ( , ( ) ( ) ( ) . such events can, in turn, affect the incidence of food-borne and water-borne disease ( , ) . the habitat and survival of insect species capable of transmitting many vector-borne diseases are affected by temperature and water regimes ( , ) . many pathogen replication cycles are also determined by temperature conditions. indirect impacts of climate change on livelihoods, such as increased economic vulnerability, reduced availability of food resources, and reduced allocation of government funding for health systems, may also have important, though unquantified, impacts on global health systems ( , , , , , ) . health impacts due to climate change have already been documented, including changes in the range of some vector-borne diseases ( , , ( ) ( ) ( ) and an increase in heatwave-related deaths ( , , ) . indirect effects will also include increases in regional food insecurity, migration resulting from environmental degradation, and loss of environmental-dependent livelihoods resulting from ecological shifts in weather or species distributions ( ) . table summarizes the reported and projected health impacts of climate change documented by the intergovernmental panel on climate change (ipcc). the ipcc, an intergovernmental body open to all united nations member countries, comprehensively assesses existing literature related to climate change science, potential impacts, and options for adaptation and mitigation. the published reports represent the consensus of thousands of scientists around the world contributing as authors and reviewers, as well as political consensus required by member countries for the acceptance, adoption and approval of the final document. these projections and measures of confidence are therefore believed to be conservative ( ) ( ) ( ) . current climate change effects on global health are small but increasing in most countries ( ) . this is due to the lag effect between greenhouse-gas emissions, climate system warming, and the weight of evidence documenting health impacts. while the burden of negative health impacts will be disproportionately high in poorer countries, even high-income countries will be vulnerable to morbidity and mortality related to increases in the number and severity of extreme weather events such as storms, heatwaves, and floods ( ) . vulnerable populations in all countries include the urban poor, the elderly and children, traditional communities, subsistence farming communities, and coastal populations ( , , ( ) ( ) ( ) . evidence does not support the potential for economic development to combat the health impacts of climate change ( ) . canada will not be immune to the health impacts of climatic change ( ) ( ) ( ) ( ) . canada has observed approximately °c rise in temperature since the beginning of the century, and we can expect this to continue by about . degree per decade, up to °c over the next century ( ) . this temperature change is not insignificant; the earth's temperature was, for example, only - degrees cooler during the last ice age ( ) . the effects of climate change in canada will differ between regions ( ) . while the prairies are expected to experience warmer, drier summers and more sever summer droughts, ontario and quebec can expect decreased snow, increased rainfall, and an increase in the incidence of severe summer storms ( ) . the greatest changes will occur in the canadian north, where temperature changes are projected to be among the highest in the world, and where traditional, resource-dependent communities are considered highly vulnerable ( , , , ) . indeed, for northern inuit communities, climate change poses a significant threat to traditional livelihoods in the short to medium term ( , ( ) ( ) ( ) . canada will experience a number of significant direct and indirect impacts of climate change ( ) ( ) ( ) ( ) . extreme heat events are expected to become more frequent, longer in duration, and more intense ( ) . extreme heat events can exacerbate health conditions, such as asthma, as well as lead to an increased number of deaths ( , , , ) . heat waves were responsible for over five hundred deaths in chicago during a -day level of uncertainty * alter the distribution of some infectious disease vectors medium confidence alter the seasonal distribution of some allergenic pollen species high confidence increase heatwave-related deaths medium confidence increase in malnutrition and consequent disorders, including child growth and development high confidence increase in morbidity and mortality related to heatwaves, floods, storms, fires, and droughts high confidence continued changes in the ranges of some infectious disease vectors high confidence mixed effects on malaria incidence and distribution (expansion in some areas, contraction in others) very high confidence increase in the burden of diarrhoeal diseases medium confidence increase in cardio-respiratory morbidity and morality associated with ground-level ozone high confidence increase in the number of people at risk of dengue low confidence health benefits include fewer deaths due to cold high confidence ( ) . children and the elderly are particularly vulnerable during heat wave events ( ) . the increasing number of summer days in urban areas of quebec and ontario declared unsafe for outdoor activity due to smog and heat can be expected to negatively impact public health through reduced outdoor and exercise activities ( ) . poor air quality, resulting from smog and air pollution, is associated with asthma, chronic respiratory disease and cardiovascular disease, and is a serious public health issue in canada. smog and air pollution are expected to continue to increase with climatic change ( , ) . toronto public health recently predicted that climate change would cause a % increase in air-pollution related deaths in the city by ( ). many regions are expected to see an increase in summer storms. this may affect risks associated with flooding, and will have implications for water quality and contamination ( , ( ) ( ) ( ) . a prolonged drought followed by a high rainfall event -such as a summer storm -can pick up surface contaminants and flush them into local waterways, causing a 'pulse' in the contaminant load of local water treatment facilities ( , ) . this scenario was determined to be one of the factors contributing to the e. coli outbreak in walkerton, ontario in ( ) . in addition, higher than normal rainfall events may exceed expected norms for sewage treatment facilities, overwhelming treatment systems. in the inuit community of arctic bay, increased rainfall has been observed to overflow the local sewage ponds, contaminating the bay and roads ( ) . these scenarios are consistent with climate change predictions and can be expected to occur more frequently. the distribution of vector-borne diseases will change ( , , ( ) ( ) ( ) . warmer and wetter summers will affect the distribution and survival of pathogens and some disease vectors such as mosquitoes and ticks ( , ( ) ( ) ( ) . research has already documented possible shifts in the distribution of the vector of lyme disease ( , ( ) ( ) ( ) , and possible expansion of the potential range of west nile virus (wnv) ( , , ) . mosquito vectors of wnv will be affected by longer summers ( , ) . increased incidence of the virus coincides with periods of prolonged hot weather and increased mosquito activity ( ) . recent research also indicates the potential for the re-emergence or emergence of exotic pathogens to canada, including locally-transmitted malaria ( ) . emergent disease risks are by nature difficult to predict. despite this, it is sensible to anticipate the spread of known diseases into new areas and the emergence of new diseases. there will also be a number of indirect effects on canadian health and health care. in many cases, these indirect pathways are difficult to identify, predict, and quantify, but may nonetheless be important for changing health systems in canada. for example, changing sea temperatures are likely to impact the distribution and availability of fish and tree species through impacts on local weather, affecting the viability or focus of fisheries and forestry industries, and by extension the community health and well-being of resource-dependent communities. in this case, the concern is not the loss of traditional species per senew species are likely to emerge to fill changing niche conditions -but the rate of change in ecological systems, and the ability of industries and communities to adapt to these changes. similarly, the dramatic spread of the pine beetle has been facilitated -and many suggest triggered -by increasingly favourable weather conditions ( ) ( ) ( ) ( ) . as in the case of the pine beetle, many of the impacts of climate change on health in canada are likely to be the result of indirect causal processes, and in some cases unforeseen events. the implications of climate change for health are not limited to global and national impacts. they will also be manifest at the municipal level (table ) and within canada's health sector ( , , ) . for canada's health system, this will result in changing risks. for example, the increased emergence of new, re-emergent and exotic diseases will mean that conventional expectations of likely diagnoses by family physicians and primary health care providers will be insufficient. the potential for malaria infection in patients with no history of travel is one such example ( ) . the increase in extreme weather events such as heatwaves, floods and storms will increase pressure on disaster preparedness and emergency health services and programming ( ) . program planning for emergency health provision will need to consider future rather than historical experiences or trends in demand and frequency of health crises ( , ( ) ( ) ( ) . increased health surveillance will be required to document baseline health measures and monitor changing health outcomes. this is particularly important in canada's northern communities where health provision and surveillance have faced significant challenges and where climate impacts will develop earlier and more rapidly than in the south ( , ) . the good news is that opportunities for avoidance of, and adaptation to, climate impacts on health are available, feasible, and in many cases of benefit to improved health in canada more broadly ( ) . given the unpredictable nature of many impacts, adaptation, prevention, and preparedness measures that increase overall health system capacity are most sensible and cost-effective -so called 'win win' or 'no regrets' responses ( , ( ) ( ) ( ) ( ) ( ) . these include: increased surveillance, particularly of disease vectors, water quality, and air pollutants; integration of climate projections into emergency planning and disaster preparedness ( ) ; improved access to preventive care and primary physician care to promote early detection of new disease emergence or shifting disease incidence; integration of climate change considerations into education programming for medical students and primary health care workers; integration of climate projection parameters into urban planning to increase protection against extreme weather events ( , ( ) ( ) ( ) ; increased monitoring and evaluation of food production systems and water monitoring safety given climate projections ( , , , ) ; development of heat wave alerts and responses, and mitigation of urban heat islands ( , , , ) , and; increased multi-national support for improved health capacity in low and middle income countries. the risk of health impacts resulting from climate change are not restricted to within our national borders. the impact of climate change elsewhere, particularly in low and middle income nations, will influence the potential for imported infection to canada. for example, the introduction and outbreak of sars in toronto in resulted in cases, deaths and significant economic losses ( , ) . international travel may have been responsible for promoting the introduction of west nile virus in north america ( ) ( ) ( ) . similarly, a canadian outbreak of imported malaria in - may have been brought to canada via travelers arriving from the punjab in india, where a large epidemic had occurred ( , ( ) ( ) ( ) . more recently, concern regarding the potential spread or proliferation of avian influenza has highlighted the interconnected nature of national health to health conditions around the world. as such, the health impacts of climate change in canada will be influenced by the health and response capacity of other nations from or to which canadians, visitors or trade products travel. in this context, adaptation, preparedness and response resources may in some cases be most effectively and efficiently allocated through supporting health capacity in other countries. increased interest and prioritization of health collaborations in asia following the sars outbreak provides a germane example of a developing awareness of such risk priorities. despite the magnitude and scope of climate change, the recent global financial crisis has overshadowed concern for, and prioritization of, climate change science, policy, and action. while the implications of economic crisis at the international and national levels are undoubtedly of legitimate priority and concern, placing climate issues on the back-burner is misguided for two reasons. first, while the financial crisis may be acute and possibly prolonged in the short term -years, but not decades -the climate change crisis will last well into the next century and beyond. investments in health system capacity and surveillance need to be implemented in advance of emerging impacts to avoid and/or mitigate morbidity and mortality. additionally, observed climate impacts will begin to rapidly accelerate over the next decade. in the absence of genuine and dramatic intervention, climate change impacts have the potential to be severe and acute on a scale greatly exceeding the current financial crisis ( , , , ) . the lack of action on climate change -including both mitigation of emissions and adaptation to current and future impacts -is generally rationalized based on the costs of interventions. the costs of a no-action approach, however, will be significant. the stern review, an independent assessment commissioned in the united kingdom, estimated that a - °c warming over the next century could result in losses of up to % of global gdp ( ); the report estimates the cost of mitigating climate emissions and severe impacts at approximately % of global gdp. the health sector, which makes up % of canada's gross national product (gnp) can make a significant contribution to climate change mitigation and adaptation in canada ( , ) . it is no longer sufficient to use our past climate experiences to assess health risks and health system requirements. future health systems and care will need to reflect changing risk conditions; these will differ from what physicians, primary care professionals, and public health professionals are accustomed to. climate will emerge in the next years and decades as an increasingly important determinant of individual and public health in canada. reduced individual and national contributions to greenhouse gas emissions to avoid severe impacts, combined with proactive planning and programming for adaptation will be required. the physical science basis. 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el niño southern oscillation and the historic malaria epidemics on the indian subcontinent and sri lanka: an early warning system for future epidemics? tropical medicine and international health falciparum malaria and climate change in the northwest frontier province of pakistan stern review on the economics of climate change joint cna/cma position statement on environmentally responsible activity in the health sector.: canadian nurses association (cna) and the canadian medical association (cma) world bank. health, nutrition and population (hnp) stats key: cord- - zzy fjf authors: hyde, e.; bonds, m. h.; ihantamalala, f. a.; miller, a. c.; cordier, l. f.; razafinjato, b.; andriambolamanana, h.; randriamanambintsoa, m.; barry, m.; andrianirinarison, j.-c.; nambinisoa, m. a.; garchitorena, a. title: estimating the local spatio-temporal distribution of disease from routine health information systems: the case of malaria in rural madagascar date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: zzy fjf background: reliable surveillance systems are essential for identifying disease outbreaks and allocating resources to ensure universal access to diagnostics and treatment for endemic diseases. yet, most countries with high disease burdens rely entirely on facility-based passive surveillance systems, which miss the vast majority of cases in rural settings with low access to health care. this is especially true for malaria, for which the world health organization estimates that routine surveillance detects only % of global cases. the goal of this study was to estimate the unobserved burden of malaria missed by routine passive surveillance in a rural district of madagascar to produce realistic incidence estimates across space and time, less sensitive to heterogeneous health care access. methods: we use a geographically explicit dataset of the , malaria cases confirmed at health centers in the ifanadiana district in madagascar from to . malaria incidence was adjusted to account for underreporting due to stock-outs of rapid diagnostic tests and variable access to healthcare. a benchmark multiplier was combined with a health care utilization index obtained from statistical models of non-malaria patients. variations to the multiplier and several strategies for pooling neighboring communities together were explored to allow for fine-tuning of the final estimates. separate analyses were carried out for individuals of all ages and for children under five. cross-validation criteria were developed based on overall incidence, trends in financial and geographical access to health care, and consistency with geographic distribution in a district-representative cohort. the most plausible sets of estimates were then identified based on these criteria. results: passive surveillance was estimated to have missed about in every malaria cases among all individuals and out of every cases among children under five. adjusted malaria estimates were less biased by differences in populations' financial and geographic access to care. average adjusted monthly malaria incidence was nearly four times higher during the high transmission season than during the low transmission season. geographic distribution in the adjusted dataset revealed high transmission clusters in low elevation areas in the northeast and southeast of the district that were stable across seasons and transmission years. conclusions: understanding local disease dynamics from routine passive surveillance data can be a key step towards achieving universal access to diagnostics and treatment. methods presented here could be scaled-up thanks to the increasing availability of e-health disease surveillance platforms for malaria and other diseases across the developing world. the lack of big data analytics in global health care delivery represents an enormous gap preventing progress toward universal health coverage . the realm of infectious diseases is a prime target for the application of these methods, as increasingly available spatial and temporal information can be harnessed in combination with epidemiological models to produce precise estimates of disease burdens , . the most common data sources used to understand burdens of endemic diseases are routine facility-based health management information systems (hmis) and household surveys. hmis data have some degree of clinical and temporal granularity and are useful for health planning, but do not provide accurate information on disease burdens because they are only representative of those who access health care. in comparison, nationally representative household surveys (e.g. demographic and health surveys) are heavily relied on for tracking development targets and establishing control priorities, but their data are clinically and spatio-temporally coarse (they are collected every years, in samples that are representative of large regions), and involve limited diagnostic tests. designated surveillance sites can add high quality data in particular locations, but are expensive and not scalable for localized planning. the prevailing approach for bridging this space is in the form of precision health mapping, where health outputs from coarse epidemiological data are fit from much more granular geospatial environmental data [ ] [ ] [ ] . though this approach produces projections at fine spatio-temporal scales over large geographic areas, these cannot be used by district managers for local planning due to limited accuracy. this represents a significant missed opportunity, because health systems are sitting on enormous quantities of granular data that could be used for local disease control if systematic biases in these data could be addressed. malaria is a good example of the challenges and opportunities in the use of health system data for disease control. despite being preventable and treatable, malaria continues to cause an estimated million cases and , deaths worldwide each year . widespread implementation of malaria control measures such as insecticide-treated bed net distribution and indoor residual spraying has resulted in a steady decrease of global incidence, but this trend has recently slowed and even reversed in some areas , . universal access to rapid diagnosis and treatment is a key strategy to reduce the burden of malaria, but access to health care remains stubbornly low in rural areas of sub-saharan africa where most of the burden accumulates . in , only one third of african children with fever were brought to a medical provider. thus, a substantial number of malaria cases were not diagnosed, treated, or included in surveillance statistics . this could be worsened under the current covid- pandemic, which is disrupting supply chains, community health and outreach activities, and could further undermine access to health facilities due to the stigma associated with covid- , . surveillance is critical for both disease control and elimination, and has become one of the three pillars of the global technical strategy for malaria - . most malaria control programs rely on passive surveillance systems via case detection at health facilities. yet, passive surveillance is known to grossly underestimate the incidence of malaria [ ] [ ] [ ] [ ] because only symptomatic patients who seek care at health facilities are recorded. in , the world health organization estimated that only % of malaria cases worldwide were detected with routine surveillance . even in countries committed to malaria elimination, nearly two thirds of cases are missed by national surveillance systems . passive surveillance is especially unsuited to estimate local malaria burdens for remote populations in rural areas, as health centers are sparsely distributed and health care utilization tends to decrease exponentially as distance to a health facility increases [ ] [ ] [ ] [ ] . active surveillance can enhance case . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint detection, but its application remains limited to near-elimination areas due to resource constraints . thus, innovations are needed to improve the use of passive surveillance data in high transmission areas in order to increase the ability of local control programs to track disease dynamics within a health district, efficiently deploy resources, and target interventions to high-risk populations. implementation of such methods could be particularly important in madagascar, one of the poorest countries in the world with one of the least-funded health systems , . malaria remains one of the leading causes of mortality in the island , with . of its . million people living in areas with high transmission . madagascar is one of only seven countries in the world where malaria incidence and mortality rates increased by more than % in compared to levels. between and , the country saw an increase of more than half a million cases . yet, during that time, only . % of children with reported fever had an rdt done and only . % were treated with an antimalarial . access to healthcare is particularly low in rural areas of the country, where over three quarters of the population live . in , the ministry of health (moh) partnered with the healthcare ngo pivot to strengthen the rural health district of ifanadiana, located in southeastern madagascar where malaria transmission is highest , to serve as a model health system for the country. in support of local malaria control efforts, the goal of this study was to estimate the burden of malaria missed by routine passive surveillance to help produce more realistic estimates of malaria incidence across space and time, less sensitive to changes in health care access. for this, we used a geographically-explicit patient dataset from the district's health centers and we adjusted malaria estimates following a detailed characterization of health care utilization drivers in non-malaria patients. . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint ifanadiana is a rural district located in the vatovavy-fitovinany region in madagascar. according to the moh, ifanadiana contained approximately , people in , the vast majority of whom subsist on agriculture ( . %) , , . the district is divided into communes (subdivisions with approximately , people each), which are further divided into fokontany (the smallest administrative unit, containing one or several villages). ifanadiana has one reference hospital, one major public health center (csb ) in each of its communes, and six additional basic health centers (csb ) in the larger communes ( figure ). passive malaria surveillance is continuously conducted at all of the public health centers throughout the ifanadiana district, aggregated from routine health registries of clinical patients. in , a baseline study indicated that ifanadiana had some of the highest poverty rates and worst health indicators in madagascar. nearly three fourths of the population lived in extreme poverty. the mortality rate for children under five was deaths per live births, more than double the national estimate of per , . malaria prevalence in the area where the district is located is the highest in the country, with prevalence ranging from to % . while more than a third of children under five in ifanadiana had reported fever in the previous two weeks, only % were taken to a health center . low access to health care was strongly associated with substantial financial and geographic barriers . for instance, only one fourth of the population lives within an hour's travel of a health center , . since , pivot has supported the public health system of ifanadiana at all levels (hospital, health centers and community health workers) guided by the who framework for health system strengthening . the intervention initially covered approximately one third of the district's population. in these areas, pivot has helped remove financial barriers to care; improved readiness at health facilities, which includes personnel (quantity of staff and training), supply chain (equipment and consumable), infrastructure, and health management information systems; created an ambulance network; and implemented clinical programs that target tuberculosis, malnutrition and childhood illness through strengthened programs at all levels of care. following pivot's support, the number of cases of malaria diagnosed at health centers in these areas experienced a sudden increase due to rapid improvements in overall health care utilization , . to further support local malaria control programs, pivot aims to support the moh to optimize interventions geographically in a context of heterogeneous disease burdens. . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint data was obtained from health center registers on all individuals who visited a public health center for an outpatient consultation in ifanadiana district between january and december . every - months, each public health center was visited and digital photos were taken of the register, in agreement with the head of the public health center. a digital database of register photos was created and stored in a secure server. de-identified information including age, fokontany of residence, and malaria status of each new patient was entered into an electronic database (follow-up visits were excluded). health center staff made malaria diagnoses with rapid diagnostic tests (rdts) for patients presenting with fever, following national guidelines. in addition to health system information, data from the i-hope cohort was used to estimate the geographic distribution of fever prevalence by age group in ifanadiana . the i-hope longitudinal cohort study, representative of the population in ifanadiana district, was initiated in to understand the evolution of health and socio-economic characteristics as one of the information pillars to create a model health district. it consists of a series of biannual surveys conducted by instat on the same households over time, with questionnaires and methods adapted from the demographic and health surveys and other international surveys. the survey has a two-stage stratified sampling design covering , households (~ people) in geographic clusters across the district. information from the . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint cohort, which was available for (april-may), (august-september) and (april-may), included questions to assess reported fever among children under five years (previous two weeks) and among all household members (previous four weeks). to obtain per capita estimates, population data for each fokontany were obtained from the moh. the population of children under five years old was estimated at % of the total population, per the moh. data on monthly stocks of rdts at the end of each month and number of days with rdt stock-outs were obtained from each health center's monthly report to the district. use of moh data for this study was authorized by the secretary general of the moh, the medical inspector of ifanadiana district, and harvard medical school irb. the i-hope cohort study was approved by the madagascar national ethics committee and harvard medical school irb. finally, we used a geographic information system containing data on locations of all health centers, more than , km of footpaths, over , buildings, and nearly , residential areas in the district. this was obtained following a participatory complete mapping of ifanadiana in - , from very high resolution satellite images available through openstreetmap . this data was queried on qgis via the quickosm plugin and was used to estimate shortest path distances between health centers and each fokontany. patient-level information from each health center was aggregated to estimate per capita utilization rates and malaria incidence per month for each fokontany in ifanadiana district. in order to obtain more realistic estimates of malaria incidence per fokontany-month, malaria incidence was adjusted to account for underreporting due to stock-outs of rdts and variable access to healthcare due to geographic and financial barriers. access-based adjustments were based on a benchmark multiplier method that used a healthcare utilization index, which was obtained from a model of fokontany per capita utilization in non-malaria patients. several multipliers and pooling strategies were explored to improve adjustments in the fokontany with the lowest access to care, and the most plausible set of estimates was identified by comparing each set of estimates according to four evaluation criteria (next section). each of these steps is explained in detail below. to account for the reduction in malaria diagnoses as a result of health center stock-outs of rdts, each fokontany was matched with its nearest health center. the shortest path distance between all health centers and fokontany (average distance for every house) was estimated via the open source routing machine (osrm) engine. the number of diagnosed malaria cases in health centers and months with stock-outs ( months) were adjusted by a factor inversely proportional to the number of days in the month when rdts were available. for example, if rdts were only available at a health center for half of the month, the adjusted malaria cases for that month would be double the original reported number. in months in which stock-outs persisted for an entire month at a given health center ( months), we assigned missing values for the malaria incidence in all fokontany served by that health center. to account for the effect of low health care access on malaria incidence, we used results from a spatiotemporal model of health care utilization in ifanadiana during the same study period. details on this model are published elsewhere , and model specifications are available in the appendix. briefly, per capita health center utilization rates for each fokontany were modeled using binomial regressions in . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint generalized linear mixed models, with a random intercept introduced for the closest health center. the model accounts for the non-linear effect of travel distance from each fokontany to the nearest health center; the impact of programs implemented to reduce financial and geographic barriers; linear and seasonal trends in utilization rates in the absence of those programs; baseline differences in the type of health center (csb or csb ); and the number of health staff over time in the closest health center . based on model predictions for non-malaria patients, a health center utilization index was produced for each fokontany-month in ifanadiana, scaled between zero (no access; set at zero consultations per person-month) and one (full access; set at . consultations per person-month, equivalent to consultations per person-year, excluding malaria). a simplified benchmark multiplier method was used to adjust malaria incidence with the health care utilization index produced from non-malaria patients. this method combines information about the known members of a target population (the benchmark; for example, the number of people with malaria who are diagnosed at a health center) with the proportion of the target population that appears in the benchmark (for example, the proportion of people with malaria who go to a health center) . the reciprocal of the proportion is called the multiplier. the true size of the target population (in this case, the true number of people with malaria in ifanadiana) is estimated as the product of the benchmark and the multiplier. populations with the best health care access (i.e. located very close to a health center with fee-exemptions in place) are not adjusted, while populations with the worst access are adjusted using the largest multiplier ( figure ). the simplified benchmark multiplier formula is defined as: where c unadj represents the unadjusted monthly cases in a given fokontany for a given month, u represents the health care utilization index for the fokontany from the model described above, and c adj represents the resulting adjusted monthly cases in the fokontany for the month. multiplying the benchmark by the multiplier ( /u) can result in drastic changes in magnitude of the resulting estimates. to account for this, the lower limit of the health care utilization index was varied from . to . in steps of . , with the upper limit remaining one. this allowed for fine-tuning of the adjusted monthly malaria incidence estimates. finally, due to extremely low access to care, several fokontany had no malaria cases for several months even during the high transmission season, particularly those located at farther distances (e.g. - km) from health centers. for instance, of the fokontany did not have any malaria cases during more than half of the high season months (december to may) in the four years of the study, % of which were further than kilometers from a health center. because fokontany that have a malaria incidence of zero during a given month cannot be adjusted using a multiplier, we explored several strategies to pool the number of malaria cases in these fokontany with the cases in neighboring fokontany and estimate a pooled incidence that could then be adjusted for low health care access. we explored pooling with the knearest neighbors ( , , and ) and with neighbors within a certain distance ( , , and km). the combination of different pooling strategies and different lower limits set for the health utilization index resulted in alternative sets of adjusted malaria incidence estimates, both for individuals of all ages and for children under five. . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . figure . illustration of benchmark multiplier adjustments to passive malaria surveillance data using a health utilization index. each dot represents the average health care utilization index (orange) or resulting multiplier (teal) for of the fokontany in ifanadiana over the study period. in this example, average per capita health care utilization inde normalized from . to , where the maximum is equivalent to visits per year (excluding malaria). both variables plotted as a function of distance between each fokontany and its nearest health center. the solid lines are smoo conditional means (loess method) and the grey areas are the % confidence intervals. fokontany with smaller health utilization indices have larger multipliers, resulting in greater adjustments after the benchmark multiplier method applied. the lack of a district-representative active surveillance survey during the study period meant alternative sets of adjusted estimates of malaria incidence from passive surveillance could not robustly compared to an unbiased training dataset for validation. we established four evaluation crit to choose the most plausible set of incidence estimates in ifanadiana based on the available data (ta ). this was done both for individuals of all ages and for children under . evaluation criteria are based on: a) consistency of overall malaria incidence in the district w incidence in areas with optimal access to healthcare; b) reduction of distance decay relationship reduction of bias due to financial access to care; and d) consistency of geographic heterogeneitie district with patterns observed in the i-hope cohort study. the first three criteria rely on the assumpt that the burden of malaria in populations with good access to health care (e.g. those who live near he centers, or in areas where user fees have been removed) is similar to the burden elsewhere because per capita distribution of malaria is predominantly driven by ecological and epidemiological factors, not by health care access [ ] [ ] [ ] [ ] . although health centers diagnose and treat malaria patients, the m malaria prevention activities in madagascar (e.g. bed net distribution, indoor residual spraying) could affect transmission are delivered through mass-campaigns to all at-risk populations. h care for one ndex is les are oothed lth care d was t that ot be riteria (table with ip; c) ties in ption health se the , and main ) that . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint table . evaluation criteria for alternative sets of adjusted malaria incidence estimates. criteria description evaluation method a) overall malaria incidence overall adjusted malaria incidence for ifanadiana should be similar to overall malaria incidence in populations with optimal health care access in the district, to avoid under-or overestimation ratio of adjusted malaria estimates to malaria in optimal access areas between . - . b) distance decay adjusted malaria incidence estimates should remove the distance decay observed in unadjusted malaria incidence, to limit bias due to geographic access to health care ratio of incidence less than km from a health center to incidence greater than km away . - . c) financial access differences in adjusted malaria incidence between health centers according to fee-exemption status should be minimal, to limit bias due to financial access to health care ratio of fee-exemption to no feeexemption in adjusted malaria estimates between . - . the geographic distribution of adjusted malaria incidence should be similar to the geographic distribution of fever reported in the i-hope cohort study percent of hotspot cluster area overlap between the two datasets during high malaria season (satscan) to avoid under-or overestimation of overall malaria incidence in the district, we assumed that adjusted estimates should be similar to unadjusted malaria incidence in populations with optimal access to health care. these were defined as populations from fokontany that are in close proximity (≤ . km) to a pivot-supported health center following initial implementation to assess this criterion, we estimated the ratio of average malaria incidence in each adjusted dataset to average malaria incidence in the higher access dataset. adjusted datasets with a ratio within % of equality ( . - . ) were considered most plausible. this first validation allowed variations in the geographic distribution of malaria but set a reasonable reference point for the district average. to limit bias due to geographic access to health care, we assumed that there should not be an exponential distance decay relationship in adjusted malaria incidence (as it was observed in unadjusted incidence estimates, figure s ). to assess this criterion, we calculated the ratio of average incidence in fokontany located fewer than km from a health center to average incidence in fokontany more than km away. adjusted datasets with a ratio near ( . - . ) were considered as most plausible. this second validation ensured that the geographic distribution of malaria incidence in the adjusted dataset was not associated with heterogeneities in geographic access to health care. to limit bias due to financial access to health care, we assumed that average adjusted incidence in the catchment of health centers that implemented user-fee exemptions should be similar to those for which user fees were in place. before adjustment, average monthly incidence of malaria among all individuals . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint and children under five inside the pivot catchment area after financial barriers to care were removed were and per population, respectively, while the average monthly incidence among all individuals and children under five living outside of this area was significantly lower: and , respectively (ratio of . and . ). to assess this criterion, we estimated the ratio of average adjusted malaria incidence in the catchment of health centers with user-fee exemptions to health centers without user-fee exemptions. adjusted datasets with a ratio within % of equality ( . - . ) were considered as most plausible. this third validation ensured that the temporal and geographic distribution of malaria incidence in the adjusted dataset were not associated with heterogeneities in financial access to health care. to assess the consistency of heterogeneities in malaria geographic distribution, we assumed that during the high transmission season (december to may) there is a geographic overlap with the distribution of reported fever in household surveys (april-may). in the high transmission season, . % of individuals of all ages and . % of children under years presenting to health centers had a confirmed malaria diagnosis. since malaria makes up a high proportion of febrile cases during these periods, geographic variations in febrile prevalence should be correlated with variations in malaria transmission. to assess this criterion, we estimated average fever prevalence for each of the clusters in the i-hope cohort, and average malaria incidence for each of the fokontany during the high transmission season. then, satscan software using the bernoulli spatial model was used to identify geographic clusters of malaria in ifanadiana district. satscan has been used in previous studies to identify spatiotemporal variation of malaria and other illnesses such as diarrheal disease , schistosomiasis , and colorectal cancer . satscan cluster analysis was applied to identify spatial hotspots (i.e. higher than expected by random) among all individuals and among children under five in fever prevalence from survey data, unadjusted malaria incidence from health system data, and each of the adjusted incidence datasets. the area overlapped by geographic hotspots in fever and malaria from these different sources were quantified ( figure ). all analyses were performed with r software, and r packages "lme ," "gstat," "rgdal," "ggplot ," "rsatscan," "spdep," "sp," "rgeos," "tidyr," and "survey" . . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . ifanadiana among all individuals during malaria high season, using unadjusted and adjusted estimates. col regions represent malaria hotspots in the various data sources and the areas of overlap in bold black. the left panel sh hotspots using unadjusted health center register data, while the center and right panels show examples of hotspots from of the adjusted datasets. the observed overlap is significantly greater in adjusted datasets, indicating impro consistency between the geographic distribution of fever in the i-hope cohort study and malaria in health center reg data after adjustments. of the , patients who attended a health center in ifanadiana district for an outpatient v between and , , patients had a known geographic location and came from within district. among these, , were confirmed malaria cases, , of which were children unde years. average malaria incidence was . per population per year, and varied greatly acr seasons. during the high transmission season (december to may), average malaria incidence was per population per month, decreasing during the low transmission season to . per month. there was a clear distance decay in malaria incidence both for individuals of all ages and children under years ( figure s in the appendix). table presents summary demographic geographic characteristics of the patient population and malaria cases that attended one of the he centers. is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . of the adjusted datasets evaluated for individuals of all ages (figure ) , only one dataset fulfilled the four criteria described above (table ) and datasets fulfilled three of the four criteria. every pooling group and lower limit of utilization index was represented among the datasets that fulfilled three but not four criteria. we observed a clear trade-off in the adjusted datasets for the different evaluation criteria. setting the lower limit for the utilization index at lower values (e.g. . - . ) resulted in better corrections for financial and geographic trends but overall incidence was above acceptable thresholds ( figure , figure s ). in contrast, setting the lower limit for the utilization index at higher values (e.g. ≥ . ) resulted in overall incidence closest to incidence in the fokontany with optimal access to care, but there remained important bias due to financial and geographic access ( figure ). the most plausible dataset was obtained using a lower limit of . for the health care utilization index in the benchmark multiplier method, and pooling fokontany with two nearest neighbors. figure shows how the adjustment in this dataset improved geographic and temporal patterns in malaria incidence, reducing the apparent difference between fokontany inside and outside of pivot intervention following user-fee removal, and removing the distance decay observed in the unadjusted dataset. for children under five, datasets satisfied the four criteria. the lower limits of utilization were higher than for individuals of all ages, ranging from . to . (table s , figure s ). similar to the trends among all individuals, setting the lower limit of the utilization index at lower values ( - . ) improved corrections for financial and geographic trends, but resulted in unacceptably high overall incidence. datasets with high utilization index values ( . - . ) and low pooling groups ( - nearest neighbors) performed best overall. the most plausible dataset was obtained using a health care utilization index rescaled from . to in the benchmark multiplier method, and pooling fokontany with three nearest neighbors. . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint table . (a) overall malaria incidence: ratio of malaria in adjusted dataset to malaria in optimal access areas. values closer to mean better performance. (b) distance decay: ratio of incidence in fokontany less than km from a health center to incidence in fokontany more than km from a health center. values closer to mean better performance. (c) trends in financial access to care: ratio of average monthly incidence in fee-exempt to non-fee-exempt populations in each adjusted dataset. values closer to mean better performance. (d) geographic consistency with i-hope cohort data: percent of overlap between hotspots of fever identified in the i-hope cohort study data and malaria incidence in each adjusted dataset. greater values mean better performance. equivalent plots including analyses for children under years can be found in the appendix. table . summary results for the four evaluation criteria in unadjusted data and best-performing adjusted malaria dataset for individuals of all ages. an equivalent table for children under years can be found in the appendix. ratio of average incidence in dataset to incidence in optimal access areas ratio of incidence < km to > km from a health center ratio of incidence in fee-exemption to non-fee-exemption areas in dataset % of hotspot clusters overlapped between dataset and i-hope cohort data unadjusted register data . . . % nearest neighbors, utilization index . - . . . % . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint using adjusted incidence estimates from the most plausible dataset, we estimated that the number of malaria cases diagnosed via passive surveillance in ifanadiana from january to december represented only % of the total number of cases that could have occurred among all individuals during the study period, and % among children under (table ). average adjusted malaria incidence was estimated at per population per year for individuals of all ages ( per per month) and per population per year for children under ( per per month). average adjusted malaria incidence per month was nearly four times higher during the high transmission season ( per ) than during the low transmission season ( per ). temporal dynamics in the adjusted dataset showed a decrease in malaria incidence from - ( cases per per year) to - ( cases per per year), with peaks in monthly incidence decreasing from almost to about cases per respectively ( figure a ). this trend is observed to a lesser degree in the unadjusted data, but when unadjusted data is disaggregated by intervention area, incidence in pivot intervention areas appear to have increased since , likely due to increased access to care in these areas. after adjustments, the average monthly incidence of malaria is higher . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint overall and more stable over time and between intervention and non-intervention areas due to adjustments for changing health care utilization ( figure a ). geographic distribution in the adjusted dataset revealed clusters of high incidence in low elevation areas in the northeast and southeast of the district ( figure b ). in addition, another high incidence cluster was observed in the western part of the district, at higher elevation and close to the limits of ranomafana national park. these high transmission clusters were stable across transmission seasons ( figure b ) and years ( figure s ). in addition, % of fokontany in ifanadiana district had an average incidence higher than cases per per month, distributed mostly in the central and southern part of the district ( figure b ). in comparison, the unadjusted dataset only revealed areas of high incidence in very close proximity to health centers along the main paved road and with user-fee exemptions in place ( figure s ), missing most relevant transmission areas. detailed spatio-temporal dynamics of malaria per month, from both the unadjusted and the most plausible adjusted dataset can be visualized in video s . is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint despite the increasing use of disease modeling and precision health mapping to inform national or regional health planning, their application remains scarce at the local level, where intervention efforts actually take place. this is especially true in rural areas of sub-saharan africa where the burden of infectious diseases is the highest. improving the quality of routine surveillance data is critical for identifying at-risk populations and targeting resources in order to achieve universal access to diagnostics and treatment, which could contribute to the elimination of endemic diseases like malaria . here, we propose a method to improve existing passive surveillance data using models of health care utilization in order to produce more realistic estimates of local disease incidence over space and time. using the example of malaria in a poor rural district of madagascar, we show that adjusted incidence estimates were less biased by differences in financial and geographic access to health care between populations. we estimated that passive surveillance in ifanadiana could have missed about in every cases of malaria individuals and out of every cases among children under five. passive surveillance systems are a cornerstone of many disease control programs because they are relatively inexpensive and can efficiently cover large geographic areas. when access to health care is relatively homogenous in a country, variations in incidence across districts help control programs identify those with higher transmission and allocate resources accordingly , . however, at the local level of a health district these systems are systematically biased towards areas of good health care access (e.g. near health centers), preventing the implementation of geographically targeted interventions in areas of high transmission. active surveillance systems, on the other hand, can capture a significantly higher proportion of cases and produce more accurate incidence estimates. unfortunately, in the case of malaria they are too expensive to be used routinely in areas of high transmission, and the results cannot be extrapolated to detect variations in malaria in regions outside of the study area or period [ ] [ ] [ ] [ ] [ ] [ ] . thus, our study fills a significant gap for malaria surveillance, which could be applicable to other diseases. using existing passive surveillance data, we were able to produce spatially-explicit estimates of malaria incidence for every community within a health district over time, identifying hotspots of transmission in communities with poor health care access that were previously invisible from passive surveillance. this could help inform local program implementation in ifanadiana and similar high transmission settings without requiring extensive resources. without improvements to passive surveillance strategies, countless preventable cases and deaths of malaria may continue to take place and go unnoticed, which could undermine goals set for a % reduction in malaria mortality and the elimination in at least countries by the year . our results suggest that only % of malaria cases were detected by routine passive surveillance in ifanadiana district. this is consistent with findings from other settings where active and passive malaria surveillance methods were compared. for example, a study in rural kenya found that the incidence of malaria in children was over three times higher when active surveillance was used compared to passive surveillance . a similar study in central india reported that malaria incidence was almost eight times higher when calculated using active rather than passive surveillance data . in , the world health organization estimated that only % of malaria cases globally were captured by routine surveillance . in ifanadiana, a mountainous landscape, poor road infrastructure and a sparsely distributed population make it difficult for patients to access health centers. more than % of paths are not accessible by vehicle, and three fourths of the population live more than an hour's walk of a public health center , , a commonly accepted threshold of low geographic access [ ] [ ] [ ] [ ] . all these factors could have led to significant underreporting of malaria, at levels compatible with estimates presented here. . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint after adjustment, we observed significant spatial variations in malaria incidence in communities across the district, with % the population ( , people) living in areas where annual incidence was twice the district's average. although malaria heterogeneity and its drivers are commonly modelled at the national and regional level [ ] [ ] [ ] , malaria can have extensive spatial variability in relatively small areas , , . for instance, fine-scale variations in socio-demographic and behavioral factors can influence malaria risk in remote communities or affect adherence to malaria control programs . moreover, local variations in environmental factors such as temperature, rainfall, land cover, and altitude have been shown to influence malaria geographic distribution - . fine-scale estimates of malaria spatio-temporal variations obtained here can then be used to characterize local socio-economic and environmental drivers of malaria risk, paving the way to the development of forecasting systems that could guide local malaria control. although our study was retrospective and we had to collect information directly from paper registers, which was extremely time and resource consuming, this approach could be scaled-up in the future to other settings and diseases that rely on passive surveillance. indeed, a push for electronic data collection to improve health information systems is underway at health care facilities of developing countries, with the current scale-up of the open source dhis (district health information software) among other platforms. these platforms can be combined with mobile tools for registering cases and track patientlevel data at different levels of care. the level of granularity and timeliness of data that these e-health platforms offer when compared with traditional health management and information systems (e.g. paperbased registries, monthly aggregation in electronic databases) opens new possibilities for disease control which are still largely unexplored. in particular, integration of feedback loops between disease modelling approaches and e-health surveillance platforms could help to ) target efforts and plan resources necessary ahead of time for specific areas and periods, reducing stock-outs and increasing case detection; and ) implement additional control activities that are predicted to minimize transmission at the population level. this study had several limitations. first, there was no active surveillance campaign during the study period that could serve as a true comparison point for selecting the most plausible set of estimates. as an alternative, we compared adjusted estimates with areas within the district that had optimal access to care and therefore were assumed to have missed few malaria cases. however, if these areas were not representative of overall malaria incidence due to heterogeneities, this could have resulted in an underor overestimation. second, many of the most remote fokontany did not report any malaria cases even during high transmission seasons. to allow for adjustments and minimize underestimation of malaria in these remote populations, we pooled these fokontany with their nearest neighbors, but this likely reduced the spatial precision of our estimates. third, even though we correct for health care access, there were still some patterns in the adjusted datasets (e.g. higher incidence around pivot-supported health centers), which could suggest an influence of unmeasured factors not accounted for in our analyses. finally, although data on rdt stock-outs was available, underreporting of the number of days without stocks in some health centers could have led to artificially low malaria estimates. despite its limitations, we are not aware of any other study that has attempted to systematically address sources of malaria underreporting to generate realistic incidence estimates from local passive surveillance systems. in conclusion, although passive surveillance at health facilities remains the prevailing surveillance system for many endemic diseases in the developing world, systematic biases in these data prevent their . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint use to inform local disease control programs within health districts. by adjusting for health care access and other sources of underreporting, we show that passive surveillance can be used to obtain realistic estimates of malaria dynamics with a level of spatial resolution that is locally actionable. future research should assess whether such methods can be scaled-up and integrated with e-health platforms currently being deployed. . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted august , . . https://doi.org/ . / . . . doi: medrxiv preprint . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. 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between mapping plasmodium falciparum mortality in africa between and characterizing local-scale heterogeneity of malaria risk: a case study in bunkpurugu-yunyoo district in northern ghana socio-economic determinants for malaria transmission risk in an endemic primary health centre in assam knowledge of human social and behavioral factors essential for the success of community malaria control intervention programs: the case of lomahasha in swaziland spatial modelling of malaria cases associated with environmental factors in south sumatra, indonesia land cover, land use and malaria in the amazon: a systematic literature review of studies using remotely sensed data impact of climate variability on the transmission risk of malaria in northern côte d'ivoire the district health information system (dhis ): a literature review and meta-synthesis of its strengths and operational challenges based on the experiences of countries we are grateful to everyone who contributed to the participatory mapping of ifanadiana, especially vincent herbreteau, christophe révillion, jérémy commins, and blake girardot. we thank the staff of the local ministry of health team in ifanadiana district as well as pivot's monitoring and community teams for their support during data collection. thanks are due to benjamin andriamihaja, benjamin roche, and mauricianot randriamihaja for their help at different stages of the project. key: cord- - y nkal authors: lee, hyeon-seung; dean, derek; baxter, tatiana; griffith, taylor; park, sohee title: deterioration of mental health despite successful control of the covid- pandemic in south korea. date: - - journal: nan doi: . /j.psychres. . sha: doc_id: cord_uid: y nkal south korea was able to successfully control the spread of covid- without nationwide lockdowns or drastic social distancing efforts, but pandemic-related psychological outcome of the general population remains unknown. between march and june , south korean residents participated in an online study of depression, anxiety, stress, psychosis-risk and loneliness, as well as indices of social network, physical health and demographics. clinical levels of depression, anxiety or stress were reported by % of the respondents, and psychosis-risk was present in . %; a drastic increase above the base rate reported by previous studies conducted in south korea prior to the pandemic. subjective feelings of loneliness, but not the size of the social network accounted for poor mental health. women were especially at increased risk for mental health problems. thus, despite effective mitigation of the pandemic, there was a striking deterioration of mental health. as the psychological burden of the continuing pandemic accrues, the probability of an impending mental health crisis is increasing, especially in countries with greater infection and death rates than south korea. comprehensive efforts to address the psychological aftermath of the pandemic are urgently needed. as of august , covid- has infected more than million people worldwide (ecdc.europa.eu). however, successful mitigation of the pandemic has been achieved in many countries owing to their nationwide efforts to administer and manage public health policies based on science. the case of south korea (population of million) is particularly illuminating in this respect. after reporting the first case of covid- on january th, (gralinski, & menachery, ; hyun et al., ) , south korea experienced exponential growth of confirmed covid- cases in the next two months (kuhn, ; shim et al., ) . to take control of the pandemic, widespread testing and contact tracing began almost immediately ) through a wellcoordinated partnership between the government and private sectors. novel test settings were launched (e.g., drive-through screening, kwon et al., ) and fast tracking of infected cases with transparent disclosure of information was made available . although extremely restrictive measures such as immigration control or nationwide lockdowns were not enacted, south korea brought the pandemic under control through an extraordinarily large volume of testing, efficient contact tracing, monitored quarantines for those who were exposed or suspected to have been exposed to the virus and universal adherence to science-based public health policies by the general public (cohen, & kupferschmidt, ; park et al., ; al-rousan, & al-najjar, ) . there was almost % compliance with mask use, self-quarantine protocols and social distancing rules. with daily cases dropping below ) and a very low mortality rate (her, ) by june, the vast majority had been spared of the disease. while the mitigation of covid- nationwide is undoubtedly a success story, the psychological wellbeing of the population during this period has not yet been closely examined. outcome data from previous epidemics (e.g. severe acute respiratory syndrome in , and the middle east respiratory syndrome in ) forewarn adverse psychiatric consequences (chan, & chan, ; sim et al., ; mak et al. ; . for example, the risk for post-traumatic stress disorder (ptsd) increased for both the survivors of these diseases and healthcare workers and psychiatric symptoms remained elevated up to six months after the end of the quarantine period (jeong et al., ) . furthermore, the psychological consequences of pandemics can be extensive across the general population regardless of exposure to the disease itself. past research indicates that, although the vast majority of the population was never infected, there was a significant psychological toll on the general population (park and yu, ) . given the severity and the scale of the current pandemic, a worldwide mental health crisis is expected in the near future (see holmes et al., ) . in addition to chronically elevated levels of stress, anxiety and fear that interfere with daily functioning due to the pandemic (jung, & jun, ) , public health strategies designed to curb the spread of the virus may have an unintended negative impact on mental health. lockdowns, quarantines and social distancing protocols protect the public but these measures also separate individuals from their regular social networks. prolonged social isolation is associated with exacerbation of stress, panic, depression, anxiety and psychosis (bo et al., ; kim, & su, ; rossi et al., ; wang et al., ; zhang, & ma, ; selten et al, ) . social isolation and loneliness have long been linked to poor mental and physical health outcomes (see leigh-hunt et al., for a review) . importantly, it has been shown that the subjective feelings of loneliness rather than objective measures of social contact or network contribute to psychosis-risk (badcock, adery and park, ; michael and park, ; benson and park, ) . indeed, the national lockdown enacted earlier this year to stem the spread of covid- may have already resulted in increased psychosis risk in the general population in italy (d'agostino et al., ) . although korea was able to avoid a nationwide lockdown, the widespread closure of public spaces, educational institutions, places of worship and other social venues have been disruptive, especially among young people whose social world collapsed when schools and colleges shut down. social isolation and disconnection due to the pandemic are likely to be even more burdensome to vulnerable individuals. indeed, as early as mid-march of , mental illness was the third most frequent underlying condition of those who died of covid- in south korea (kang, ; kim, & su, ) . a recent survey of hong kong residents underscores the pivotal role of loneliness in extraordinarily high levels of psychiatric distress during the pandemic, with almost two-thirds of the respondents reporting depression or anxiety disorders and about a quarter meeting the criteria for psychosis-risk (tso and park, ) . similar to south korea, hong kong was not severely affected by covid- owing to its early and successful public health efforts to limit the spread of the disease. in contrast to koreans, hong kong residents were forced to undergo a complete lockdown leading to extreme social isolation. furthermore, hong kong had been under prolonged political turmoil and uncertainties that were already generating high levels of stress before the covid- pandemic hit (ni et al., ) . thus, one might expect the psychiatric impact of covid- to be less severe in korea than in hong kong. the major aim of the present study was to survey mental health and social wellbeing during the covid- pandemic among the general population in south korea where effective public health strategies and high compliance by the residents were able to successfully stop the spread of the virus. by investigating psychological consequences of the pandemic in a country, which largely escaped the ravages of the covid- , we sought to observe mental health outcomes under the best case scenario. in particular, we wanted to elucidate demographic factors (e.g., age, gender, living situation) associated with increased risk or protective factors for psychiatric conditions. moreover, we hypothesized that there would be adverse psychological consequences of living under the pandemic conditions in relation to social disconnection. four hundred three participants viewed the introduction page of the online survey in korean from march , to june , . among those, ( . %) met the criteria for the survey by their self-reported age (i.e., over ) and current residence in south korea at the time of the survey). all respondents completed the survey. all participants completed the survey in korean using the google form platform (available at https://forms.gle/ zkooaxm zfyznuya). the survey link was disseminated using social media, local online communities, websites and by word-of-mouth in south korea. this study did not collect any personal or identifying information, such as name, date of birth, contact information, ip address, ethnicity or other potentially identifying information, guaranteeing the total anonymity and privacy of the respondent, and therefore received an exempt status from the vanderbilt university institutional review board (irb# ). participants were asked to respond to questions about their demographic information (age, sex, education level, occupation, marital status), levels of concern about the covid- pandemic from "not at all concerned" to "extremely concerned", general physical health status, mental health, loneliness and social network. for general physical health, participants reported their health status on a -point likert scale, from "poor" to "excellent". subjects also reported the number of days in the past month that they experienced health problems with respect to physical and mental health, disturbances in daily activities, alcohol and tobacco use, pain and worry. the -item version of the depression anxiety stress scale (dass; lovibond, & lovibond, ) and the -item version of the prodromal questionnaire (pq- ; ising et al., ) were used to assess the mental health of the respondents. dass was used to assess depression, anxiety and stress levels, classifying the severity from "normal" to "extremely severe". pq- assessed psychosis risk with a total score of or higher indicating high-risk status (ising et al., ) . in addition to pq- , there were two items that asked directly about dissociative experiences (out-of-body experience) and voicehearing. the ucla loneliness scale (russell, ) was utilized to measure subjective feelings of loneliness. the size and the diversity of social network of the respondents were collected to obtain an objective index of social isolation using the social network index (sni; cohen, ) . first, descriptive data for demographics, general health questions and mental health items were examined. then, we compared physical and mental health status between demographic subgroups. we used independent t-tests to compare participants in terms of age (old vs. young), sex, employment status and occupation (healthcare worker vs. non-healthcare worker). family relationships play an outsized role in the quality of life of south koreans. the majority of south koreans live with their families until marriage, and often after marriage as well (see yang, ) . we classified family and living arrangement across the whole sample with three groups: married couples (or cohabiting partners), singles living with family and singles living alone. we expected the singles living alone to fare worse during covid- since they are the most likely to be socially disconnected. a series of one-way ancovas, controlling for age and sex, were used to examine family and living arrangement differences. a series of hierarchical linear regression analysis was used to examine the contributions of loneliness and social network size on physical and mental health variables. in the first step, independent variables for age, sex and concern for covid- were used to form the basic model. in the second step, loneliness, social network diversity and social network size were included in the full model. for each dependent variable (e.g., self-reported health, days physically ill, days when physical and mental health limited engagement in usual activities, days in which pain limited functioning, days mentally ill, days feeling anxious, dass and pq-scores), the change in r between the basic model and full model was used to examine whether the addition of loneliness and social network explained more of the variance in each physical or mental health variable, after controlling for age, sex and covid concern. bonferroni correction of p < . was applied to minimize type i errors. the majority of the respondents ( . %) identified as female, . % as male and . % as other or preferred not to answer. mean age was . years (sd = . ; range, - ). mean years of education was . (sd = . ). . % were single, . % were married or cohabiting with a partner and the rest preferred not to answer. . % were employed and . % were unemployed ( % preferred not to answer). only % (n = ) of the total sample were healthcare workers, who made up . % of the total number of employed participants. please see table for details. --- table --- no respondent reported a diagnosis of covid- . one participant was in selfquarantine due to suspected exposure to covid- but was asymptomatic. the mean rating for self-reported overall health (excellent = ; very good = ; good = ; fair = ; poor= ) was . (sd = . ), with . % reporting (good) or above. forty-percent of the respondents reported one or more of the following types of illnesses in the past days: head cold or chest cold ( . %); gastrointestinal illness with vomiting or diarrhea ( . %); flu, pneumonia or ear infections ( . %); or an ongoing or chronic medical condition ( . %). only . % smoked (m = . packs/day, sd = . ) but . % drank alcohol (m = . drinks/week, sd = . ). among the smokers and drinkers, . % reported smoking and . % endorsed drinking more than usual in the past days. figure represents the number of days (in the past month) during which participants reported experiencing significant health problems. psychological problems (i.e., poor mental health, or feeling worried, anxious or tense) were responsible for more days lost to illness or disability than physical health issues (i.e., poor physical health or pain). ---figure --- depression, anxiety, and stress (dass- ). the mean subscale scores were . (median = , sd = . ) for depression; . (median = , sd = . ) for anxiety; . (median = , sd = . ) for stress. we used the published cut-off scores (crawford, & henry, ) to determine the proportion of participants experiencing at least moderate levels of depression, anxiety and stress. depression was present in . %, anxiety in . %, and stress in . % of the participants. furthermore, % (n = , % ci [ . %, . %]) of the respondents endorsed moderate or higher symptoms on one or more of the subscales. see figure . prodromal psychosis (pq- ). mean endorsed items was . (median = , sd = . , range = - ). mean distress score was . (median= , sd = . , range = - ). according to the published cut-off score of or more endorsed items (ising et al., ) , . % (n = , % ci [ . %, . %]) of the respondents were at increased risk for psychosis. in addition to the pq- , there were two items that asked directly about the presence of out-of-body experience (obe) or auditory hallucinations. % reported experiencing obes, and . % reported having auditory hallucinations. loneliness. on the ucla loneliness scale, the mean score of the respondents was . (median = ; sd = . ), comparable to the reported norms of the north american (russell, ) , and validated norms from south korean (kim, a (kim, , b samples. social network index. the mean number of high-contact social roles was . (median = , sd = . , range = - ). the mean number of people with whom the respondents had regular contact (i.e., at least once every weeks) was . (median = , sd = . , range = - ). we examined the effect of age by splitting participants into two groups about the mean (m = . , sd = . ). older participants reported greater concern for covid- (t = . , p < . ) and worse general physical health (t . = - . , p < . ). there were no differences in age groups for days of physical health (t = . , p = . ), there were significant differences between women and men on most physical and mental health variables. women reported worse general health ratings (t = - . , p = . ), more days of physical (t . = . , p < . ) and mental health problems (t . = . , p < . ), more days when their usual activities were affected by health problems (t . = . , p < . ) or pain (t . = . , p = . ), and more days when they felt worried, anxious or tense (t = . , p = . ). men and women did not differ on the levels of concern for covid- (t = . , p = . ). on the dass subscales, women scored higher than men on stress (t = . , p = . ) and depression (t = . , p = . ) but not on anxiety (t = . , p = . ). more women ( . %) reported clinical levels of depression than men ( . %) (χ = . , df = , p < . ). clinical levels of one or more of the dass subscales were reported by . % of women compared to . % of men (χ = . , df = , p = . ), indicating heightened emotional distress in women during the pandemic. there were no sex differences in the pq- scores (total: t = . , p = . ; distress: t = . , p = . ) and loneliness (t = . , p = . ). see figure . ------ figure ----with regard to family and living arrangements, there were no differences between family groups in terms of covid concern, self-reported general health, days physically ill, days when usual activities were affected by health problems, days affected by pain, days mentally ill, dass-stress, dass-anxiety and pq- . there were significant differences between singles living with family, married couples, and singles living alone for days feeling worried, anxious or tense (f , = . , p = . ), dass depression (f , = . , p = . ), and ucla loneliness (f , = . , p = . ). posthoc comparisons using a tukey hsd correction showed that singles living with family experienced more days of worry than people who were married. there was a marginal difference between for days feeling worried between singles living alone and married couples. single people living alone and with family reported experiencing more depression and loneliness than married people. there were no differences between singles living alone or with family in terms of depression and loneliness. detailed information can be found in the supplementary table s . employment, education and healthcare worker status did not have a significant effect on any of the physical or mental health variables. hierarchical linear regression was used to examine the effect of loneliness and social network on general health and mental health ratings. each full model showed a significant change in the magnitude of r , suggesting that loneliness and social networks explained some of the variance in general health and mental health variables. when individual estimates were examined within each model, loneliness but not the size of social network was solely responsible for the change in r , ranging from . % to . %. see table and supplementary table s . --- table --- the primary goal of the current study was to investigate the psychological wellbeing of south korean residents during the covid- pandemic. successful management of covid- in south korea was achieved by proactive, nationwide interventions conducted by the government and the high compliance of the general public. however, the results of the present study indicate signs of psychological distress. many respondents reported suffering from mental health issues and feeling worried, anxious or tense days out of on average. importantly, clinical levels of depression, anxiety or stress were reported by nearly half of the respondents. these numbers vastly exceed previously reported -month prevalence rates of depression ( . %) and generalized anxiety disorder ( . %), surveyed by the korean ministry of health and welfare using a similar measure, prior to the current pandemic (see hong et al., ) . psychosis-risk was elevated in a noticeably higher proportion of the population during the covid- pandemic compared with the prevalence of . % reported in a validation study of the korean version of the prodromal questionnaire . overall, these findings suggest a significant psychological impact of the covid- pandemic on the mental health and social wellbeing in south korean, with high rates of depression, anxiety, stress and psychosis-risk. we observed significant sex differences in psychological and physical wellbeing; physical and psychological suffering were greatly exacerbated in women. women reported significantly more days with physical and mental health problems and higher levels of stress and depression than men. according to the korean government, the month prevalence rates of depression and anxiety prior to the pandemic were higher for women than men but the difference was small. however, our data indicate a stark and concerning sex difference in mental health outcomes of women during the pandemic. this observed gender disparity in our study may reflect the fact that gender inequality in south korea is consistently ranks as one of the worst in the world despite the fact that women are well-educated, participate in the workforce and have excellent healthcare. the gender pay gap, already one of the worst among the industrialized nations (the world economic forum, ) got much worse during the pandemic as the unemployment rate among women disproportionately skyrocketed (kim, ) . these disparities are layered upon cultural expectations that place disproportionate burden of housework and childcare on women, which may greatly compound the pandemicrelated distress. however, to better understand these findings, more comprehensive investigations of women's mental health are warranted and our findings underscore the importance of developing targeted strategies for supporting women during the pandemic. loneliness was not significantly elevated above the reported pre-pandemic norms from north american (russell, ) or south korean (kim, a (kim, , b studies. however, the majority of the respondents ( %) lived with their families and there was no nationwide lockdown in korea. thus, a partial maintenance of social life was possible for most people even though schools, colleges and many workplaces were closed for a prolonged period. nevertheless, loneliness emerged as a significant predictor for the self-reported general health ratings and mental health variables, even after controlling for age, sex and the degree of concern for covid- . in contrast, objective measures of social isolation (e.g. social network size) did not significantly predict physical or mental health variables. these findings underscore the importance of loneliness in the context of public health but it is crucial to understand how and why loneliness might arise. it is commonly assumed that living with family would reduce loneliness. families are often sources of emotional, social and financial support but some families are also fraught with hostilities, conflict and distress. we found that marital status and family living arrangement played a significant role in loneliness and depression. in korea, single adults (i.e., unmarried or without long-term romantic partner) usually live with their families rather than alone. we asked if singles who live with their families fare better than singles who live alone. singles, regardless of their living arrangements fared worse than couples especially with respect to depression and loneliness but surprisingly, there was no difference in mental health outcome between singles living alone versus singles living with family. in other words, living alone itself was not necessarily detrimental to mental health during this period. however, the quality and type of relationships mattered more than physical proximity to family members. for example, singles living with family reported more days spent worrying than did married couples. here, the concept of expressed emotion (ee) may be relevant (see hooley, ) . ee is a measure of family environment that captures the degree of hostility and negative emotions. importantly, high ee predicts worse clinical outcomes across a wide range of psychological conditions (hooley, ) . during the pandemic when korean residents suffered a significant narrowing of their usual social life, time spent at home increased dramatically. extended contact with family members may reduce social isolation but could also increases exposure to high ee. we do not have data on family dynamics but anecdotally, we observed that out of participants who reported experiencing some form of abuse (verbal or physical) recently, the majority were singles living with family. whilst this sample is too small to draw any conclusions, this observation underscores the complex relationships among family dynamics, loneliness and mental health. future research could further elucidate individual differences and family environment that may contribute to increased risk for mental illness. overall, the impact of loneliness on mental health needs to be interpreted in the context of family structures and culture as each society struggles to adapt to the pandemic. compared to a recent study in hong kong (tso, & park, ) , the psychological impact of covid- appears to be milder in south korea. fewer people met the clinical levels of depression, anxiety, stress and psychosis-risk in south korea. moreover, the average number of days the respondents reported feeling worried, anxious or tense was half ( . days) of that reported by those in hong kong ( . days). south korea's adoption of less restrictive social distancing measures might be a factor, but the greater severity of psychological distress reported by hong kong residents might also reflect ongoing civil unrest that had already traumatized the city (ni et al., ) . sociopolitical unrest is widespread, with many countries including the united states experiencing violent conflicts. mental health consequences of covid- should be examined within the social and political context of each nation in order to implement culturally appropriate interventions. there are several caveats. first, a large number of the respondents were young university students and was disproportionately made up of women, which limits generalizability to the whole south korean population. second, the results of this study convey a snapshot of a highly organized and efficient country meeting the unprecedented challenges of a global catastrophe; sociocultural aspects of the response to the pandemic may not generalize to other countries. fourth, this crosssectional design does not allow us to track psychological wellbeing over time. future studies are needed to build a fuller picture of the psychological impact of covid- as the pandemic settles into a chronic situation. nevertheless, the results of this study clearly indicate that successful management of the pandemic is insufficient to protect the general public from disconcerting deterioration of mental health. since the beginning of the covid- pandemic, many have predicted future mental health crises (holmes et al., ) . whilst covid- might have a greater psychological impact on individuals with existing psychiatric disorders (kang, ; kim, & su, ) , our findings indicate that the general public is also at elevated risk for psychiatric disorders even when the pandemic is under control. it is important to reduce loneliness, improve the quality of social relationships and provide targeted support for women. as covid- continues to disrupt the lives of billions of people, comprehensive public health efforts must be implemented to meet the difficult challenges of prolonged psychological distress.  covid concern: self-reported concern for covid- in -point likert-like scale ( =not at all concerned to = very concerned)  general health: self-reported general health in -point likert scale ( =poor to = excellent health)  days physically ill: the number of days physical health was not good in the past month  days disable: the number of days usual activities were affected due to health problems in the past month  days difficult: the number of days usual activities were affected due to pain in the past month  days mentally ill: the number of days mental health was not good in the past month  days anxious: the number of days felt worried, anxious, or tense in the past month  dass: the -item version of the depression anxiety stress scale  pq: the -item version of the prodromal questionnaire  loneliness: a total score on the ucla loneliness scale better together: effects and treatments of loneliness and social isolation across the schizophrenia spectrum 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residents during the covid- epidemic: role of loneliness immediate psychological responses and associated factors during the initial stage of the in china family structure and relations patients with mental health disorders in the covid- epidemic impact of the covid- pandemic on mental health and quality of life among local residents in liaoning province, china: a cross-sectional study sohee park: conceptualization, methodology, writing (original draft, reviewing and editing), resources, supervision, project administration, funding acquisition formal analysis, writing methodology, data curation, writing (original draft, reviewing and editing) methodology, data curation, writing (original draft, reviewing and editing). declarations of interest: none we would like to thank lenie torregrossa, hafsah diakhate, jason scott, sunil shenoy, iris kim and catherine martinez for their helpful comments and support.funding information.this work was supported in part by the gertrude conaway vanderbilt endowment. key: cord- - vs mq authors: zhou, tongxin; wang, yingfei; yan, lu; tan, yong title: spoiled for choice? personalized recommendation for healthcare decisions: a multi-armed bandit approach date: - - journal: nan doi: nan sha: doc_id: cord_uid: vs mq online healthcare communities provide users with various healthcare interventions to promote healthy behavior and improve adherence. when faced with too many intervention choices, however, individuals may find it difficult to decide which option to take, especially when they lack the experience or knowledge to evaluate different options. the choice overload issue may negatively affect users' engagement in health management. in this study, we take a design-science perspective to propose a recommendation framework that helps users to select healthcare interventions. taking into account that users' health behaviors can be highly dynamic and diverse, we propose a multi-armed bandit (mab)-driven recommendation framework, which enables us to adaptively learn users' preference variations while promoting recommendation diversity in the meantime. to better adapt an mab to the healthcare context, we synthesize two innovative model components based on prominent health theories. the first component is a deep-learning-based feature engineering procedure, which is designed to learn crucial recommendation contexts in regard to users' sequential health histories, health-management experiences, preferences, and intrinsic attributes of healthcare interventions. the second component is a diversity constraint, which structurally diversifies recommendations in different dimensions to provide users with well-rounded support. we apply our approach to an online weight management context and evaluate it rigorously through a series of experiments. our results demonstrate that each of the design components is effective and that our recommendation design outperforms a wide range of state-of-the-art recommendation systems. our study contributes to the research on the application of business intelligence and has implications for multiple stakeholders, including online healthcare platforms, policymakers, and users. internet technologies enable information to be generated and disseminated at almost no cost, which accelerates the growth of information in online environments. social media platforms, for example, allow users to share abundant content, including blogs, music, videos, and other formats, which individuals can freely choose to consume. although various information options increase individuals' choice opportunities, having too many choices can be overwhelming and sometimes even confusing. often, individuals experience difficulties in spotting content that is truly relevant to themselves or in which they are indeed interested (konstan and riedl ; ricci et al. ) . such a choice overload issue can lessen users' experience and create barriers to individuals' engagement in online platforms. online healthcare communities (ohcs), which are social-media-based platforms that gather users with similar health-management interests, are no exception. due to their easy access, ohcs are increasingly being used by individuals to learn about their illness, become familiar with treatment routines, and connect with others in similar circumstances. typical ohcs provide users with various healthcare interventions to promote healthy behavior and improve adherence. examples include behavioral treatment programs or plans that help individuals to establish healthy habits in regard to diet and physical exercise. during the recent covid- pandemic, for example, individuals often engage in online work-out activities to relieve stress and stay healthy (pew research center ). individuals can freely choose interventions in which to participate in an online environment. when faced with too many choices, however, individuals may find it difficult to decide which option to take, as they may not know what would work or even what to expect, especially when they are not healthcare professionals and do not have adequate experience in evaluating each choice. as a result, they may fall into analysis paralysis (oulasvirta et al. ) and fail to engage in any health-management activities. this may harm their self-intervention adherence and outcome (nutting et al. ; snyderman and dinan ) . the choice overload issue significantly affects one's participation experience or outcome in ohcs, leading to the pressing demand for services that can better fit individuals' healthcare needs. therefore, in this study, we aim to follow the design-science paradigm to develop a personalized healthcare recommendation system as a means to support individuals' engagement in health management. recommendation systems are intelligence-based algorithms that can help users to filter information and discover alternatives that they might not have found otherwise (konstan and riedl ; vozalis and margaritis ) . existing recommendation systems deploy various approaches to learn users' preferences from user-behavior data, such as collaborative filtering, content-based filtering, and hybrid models . research has shown that recommendation systems can effectively improve business performance and customer experience (konstan and riedl ; pu et al. ) in ecommerce settings. despite their extensive use in ecommerce settings, whether and how recommendation systems can be integrated with online healthcare platforms has received little attention and remains largely underexplored. there are several unique patterns associated with users' health behaviors that create challenges in healthcare recommendations. first, previous health studies suggest that individuals' health behaviors are frequently affected by their evolving health status and health-management experiences (johnson et al. ; king et al. ; yan and tan ) . thus, individuals' healthcare needs can exhibit strong temporal dynamics. second, individuals' health management usually contains multi-dimensional effort, as promoting health requires individuals to make a series of changes in all aspects of motivation and lifestyle. for instance, in weight management, individuals need to jointly monitor and manage different behavioral aspects, such as dietary behaviors and participation in physical activities. these patterns indicate that individuals' healthcare needs can be diverse, as individuals may need support for each type of health-management activity. given these unique patterns of individuals' health behaviors, conventional recommendation systems that are proven effective in ecommerce settings may not be effective in the healthcare context. this is because these algorithms generally exploit historical data to learn users' preferences. as individuals' health behaviors are continually changing, their health-behavior variations may not be fully captured by the historical data, especially when individuals' health-behavior data remain limited. thus, a mere exploitation of historical data may not be sufficient in healthcare recommendations. in addition, when individuals do not have well-established preferences about healthcare interventions, they may dynamically form their preferences based on the recommended items. the conventional recommendation systems do not take into account such interactions between users and recommendations and, thus, may not be effective in improving long-term recommendation performance (liu et al. ) . finally, conventional recommendation systems are generally shown to over-specialize recommendations (fleder and hosanagar ; pariser ) . thus, they may not well support users' diverse healthcare needs. these research gaps motivate us to propose a novel recommendation design that utilizes a multi-armed bandit (mab) as the main building block. an mab is an online-learning framework in statistics and machine learning for solving decision-making problems in noisy or changing environments (auer et al. ; chapelle and li ) . specifically, when decision-makers (e.g., service providers) do not know the outcome of an action (e.g., recommendation), an mab can help them to sequentially select choice alternatives while actively gathering information on each alternative's expected payoff (zeng et al. ) . in this process, an mab strikes a balance between exploiting the learned knowledge to gain immediate rewards (reusing a highly rewarding alternative from the past) and exploring potential better alternatives (trying new or less-used alternatives to gather more information), which is known as the "exploitationversus-exploration" tradeoff. by doing so, an mab aims to maximize the cumulative reward during the entire decision-making period. in the healthcare recommendation context, service providers tend to have little knowledge about users' healthcare preferences, as individuals may constantly change their health behaviors and healthcare needs. thus, the mab framework can be used in such a setting to efficiently guide the learning of users' changing healthcare needs. in addition, through the exploration process, an mab framework can promote the discovery of users' diverse healthcare needs, which may not be revealed by their historical behavior data. to better adapt an mab to the healthcare-recommendation context, we follow prominent healthbehavior theories to further extend and enhance a standard mab by synthesizing two model components, deep-learning-based feature engineering and diversity constraint. first, we design and implement two deeplearning models to extract user embeddings and item embeddings, which enables us to capture information that is critical to a healthcare decision-making context, such as users' health histories and health-behavior sequences (johnson et al. ; king et al. ; yan and tan ) and intrinsic attributes of healthcare interventions. taken together, the constructed user embeddings and item embeddings help to improve the personalization and contextualization of healthcare recommendations. the second model component is incorporated based on social cognitive theory (sct) (bandura ; bandura ) . sct proposes a classic paradigm for understanding individuals' personal-influenced-based health-management behaviors. based on sct, we theorize the major dimensions of health management, and we use a diversity constraint to ensure that recommendations are structurally diversified along each of the health-management dimensions, so that individuals are provided with well-rounded support. to this end, we propose a thompson sampling (ts)-based algorithm to solve this constrained recommendation task. our proposed recommendation framework is evaluated through a series of experiments, using data collected from a leading non-commercial online weight-loss platform in the united states. the focal platform provides weight-loss challenges to users, which are structured behavioral treatment programs to help users to manage short-term weight-loss goals, such as changing a dietary behavior, increasing physical exercise, and reducing weight in certain periods. we apply our recommendation framework to this weightmanagement setting to help users to find the most relevant challenges as a means to improve their engagement in weight-management activities. our evaluation results suggest that each of our proposed model components is effective and that our recommendation framework significantly outperforms a wide range of benchmark models, including ucb, e -greedy, and state-of-the-art conventional recommendation systems, such as context-aware collaborative filtering (cacf), probabilistic matrix factorization (pmf), and content-based filtering (cb). in addition, we demonstrate that our recommendation framework can more effectively learn the dynamics and the diversity distribution in users' challenge choices. from users' perspectives, we find that our recommendation design can serve to benefit a larger user population on the platform. finally, we take a further step to evaluate our recommendation performance with respect to users' weight-loss outcomes. the evaluation results suggest that our proposed recommendation design can help users to achieve the highest average weight-loss rate compared to the benchmark models. our study makes several key contributions to the literature and practice. first, one major contribution of our study is the proposed healthcare recommendation framework, which demonstrates that prescriptive analytics can be integrated via a design-science artifact (abbasi et al. ; chen et al. ) to provide decision-making support for individuals' health management. the novel aspects of our recommendation framework include ( ) a deep-learning-based feature engineering procedure, ( ) a domain-knowledgedriven diversity constraint, and ( ) a customized online-learning scheme. to the best of our knowledge, our study is among the first to combine an mab with deep context representations and to introduce recommendation constraints for diversity promotion. second, from a practical perspective, our recommendation framework can be applied to address real-world challenges in healthcare recommendations. online healthcare platforms can adopt our recommendation design to improve users' health-management experience on the platform. finally, the design of our recommendation framework can be further generalized to settings beyond healthcare. the online-learning scheme of an mab enables decision-makers to adaptively adjust their strategies to minimize opportunity cost, and the deep-learningbased feature engineering procedure can help decision-makers to better understand the context-dependency of their decision results. our study is related primarily to two streams of literature, that is, individuals' health management and recommendation systems. in the following, we first review prominent health-behavior theories to identify the unique behavior patterns associated with individuals' health management. this discussion provides the theoretical foundation for our recommendation design. we then review the existing recommendation algorithms and discuss their limitations in delivering healthcare recommendations with respect to individuals' health-behavior patterns. finally, we introduce an online-learning framework, mab, which has gathered increasing attention from the literature for its capability of solving decision-making problems under uncertainty. we explain how an mab framework can be implemented in capturing individuals' health-behavior patterns in the healthcare recommendation process. individuals' lifestyles play a significant role in affecting their quality of health. poor health behaviors, such as smoking, alcohol abuse, and sedentary living habits, have been shown to be associated with multiple health risks (cdc ). thus, the management of personal health usually requires individuals to invest effort into making a health-behavior change. for example, in managing a chronic condition, such as obesity or type diabetes, patients need to continually self-regulate their ongoing lifestyle in regard to dietary behaviors and participation in physical activities. researchers have found that patients' active engagement in health management is generally associated with improved adherence to treatment plans and better health outcomes (nutting et al. ; snyderman and dinan ) . according to prior health-behavior studies and theories (bandura ; bandura ; johnson et al. ) , individuals' health management may exhibit unique patterns, such as behavior dynamics and diversity. these patterns play a decisive role in shaping individuals' preferences for healthcare interventions and affect the design of healthcare recommendation systems. in the following, we introduce several prominent health-behavior theories to motivate our recommendation design. previous health studies have generally depicted individuals' health management as a dynamic process. johnson et al. ( ) suggested that, in the process of health management, individuals may frequently adapt their health behaviors based on their personal health condition and health-management experiences, such as treatment compliance, self-monitoring, and healthcare-knowledge seeking. in addition, the social environment may dynamically transform individuals' health behaviors by affecting mental well-being (king et al. ; yan and tan ) . for instance, the exchange of emotional or informational support among peers may encourage optimism and self-esteem of individuals (dimatteo ), which can help them to better comply with a treatment plan and make a behavior change (johnson and wardle ; krukowski et al. ; wang et al. ) . together, these studies indicate that individuals' health behaviors need to be understood with respect to specific health and social context. as health and social context may evolve with time, individuals' health behaviors generally exhibit strong temporal dynamics. psychosocial theories have extended our understanding of how cognitive and social factors contribute to personal health, among which sct (bandura ; bandura ) is widely used in the health literature to describe individuals' health-management behaviors. sct proposes a personal-influence-based selfregulation model, in which individuals exert control over their motivation and behaviors to achieve better health outcomes. the theory suggests that individuals' self-regulation contains multi-dimensional effort. first, individuals need to set proper health goals to motivate themselves toward a desirable health outcome. second, individuals need to operationalize their goals into actual behavioral aspects so that they can gain behavior-management skills and strategies to tackle challenges and fulfill expectations effectively. depending on health contexts, individuals may need to attend to different behavioral aspects at the same time. in weight management, for example, individuals need to manage both their dietary behaviors and physical activities to control their calorie intake and expenditure. based on sct, there are two major health-management dimensions: outcome-oriented dimension(s) and behavior-oriented dimension(s). the former influences individuals' motivation for health behaviors, whereas the latter affects the course of behavior execution. corresponding to these dimensions, individuals may need different types of support to guide them through the self-regulation process. for instance, individuals may need instructions on setting reasonable health goals to help them understand and manage their progress toward a targeted health condition; as well, they may need suggestions on how to cope with difficulties in the process of establishing health-behavior routines. these patterns indicate that individuals' healthcare needs can be diverse. the dynamic and multifaceted nature of health management has brought new challenges in healthcare recommendations. in this section, we review the existing recommendation systems to discuss the research gaps associated with conventional recommendation schemes that have impeded them from addressing individuals' unique health-behavior patterns. recommendation systems are intelligence-based decision-making algorithms that can help users to filter information or product choices based on their own preferences or interests, especially when there is information or product overload (konstan and riedl ; vozalis and margaritis ) . during the last few decades, recommendation systems have garnered considerable attention from both academia and industry for their capability in delivering personalized services and generating benefits for service providers and customers (isinkaye et al. ; pathak et al. ; pu et al. ). in the literature, a large body of research has focused on batch-learning-based recommendation systems, such as collaborative filtering, content-based filtering, and hybrid models ). these recommendation systems generally adopt a "first learn, then earn" recommendation scheme. that is, they first learn users' preference patterns based on a series of historical data, and then they fully exploit the learned knowledge to make future recommendations. for example, collaborative filtering makes recommendations based on similarities in users' item-selection histories (adomavicius and tuzhilin ; sedhain et al. ) , and content-based filtering leverages the content attributes of users' previously selected items (bieliková et al. ; pon et al. ). previous studies have proposed a variety of techniques to learn users' preference patterns from historical data, such as context-aware recommendation systems (cars) that model contextual dependency of users' behaviors, and model-based techniques to learn latent user representations. the "first learn, then earn" scheme, however, is based on the assumption that users' preferences have a static pattern that can be well represented by the historical data (adomavicius and tuzhilin ; sahoo et al. ) . when users' preferences are constantly changing, such recommendation methods may become less effective in adapting to individuals' behavior dynamics, as it is likely that individuals' preference patterns will not be fully captured by the data. in addition, prior studies have generally shown that the batchlearning-based models tend to over-specialize recommendations in the long run (yu et al. ), as they tend to focus on well-known items that already have accumulated adequate historical information, whereas the items with limited historical data will be overlooked (fleder and hosanagar ; pariser ) . as a result, these models can be ineffective in satisfying individuals' diverse healthcare interests. these research gaps motivate us to propose an online-learning scheme, i.e., multi-armed bandit (mab), to address the dynamics and diversity in individuals' health behaviors to improve healthcare recommendations. in most real-world decision-making scenarios, decision-makers usually do not know the expected utility of an action and can learn only from experience (cohen et al. ; mehlhorn et al. ; speekenbrink and konstantinidis ) . in statistics and machine learning, multi-armed bandit (mab) has been proposed to explicitly formulate such decision-making scenarios under uncertainty (auer et al. ; gittins ) . specifically, an mab models a sequential decision-making problem in which the underlying reward distribution for each action is unknown, and data can be obtained in a sequential order to update knowledge of the reward distribution. the rationale of an mab algorithm is to adaptively learn the reward associated with each action while gathering as much reward as possible during the entire decision-making process, that is, earning while learning (misra et al. ) . in order to do so, an mab strikes a balance between exploration and exploitation (kim and lim ; li et al. ; tang et al. ) . that is, on the one hand, an mab reuses highly rewarding alternatives from the past to ensure explicit short-term rewards, that is, "exploiting" the environment (cohen et al. ; mehlhorn et al. ) ; on the other hand, it takes actions to learn the outcome associated with the less-explored alternatives to minimize opportunity cost, that is, "exploring" the environment (cohen et al. ; speekenbrink and konstantinidis ) . it is worth noting that the online-learning scheme stands in contrast to batch-learning algorithms. the former actively collects data to learn the environment, with a forward-looking goal of maximizing longterm rewards. in other words, online learning may deviate from the current "best" knowledge from time to time in exchange for potential better learning performance and higher rewards collected in the future. in contrast, batch-learning algorithms fully exploit the current knowledge without exploring potential better opportunities that are not shown in the historical data. as such, they tend to interact with the environment in a passive and myopic manner and may not learn effectively when the environment contains many uncertainties that cannot be represented by current data. research has shown that online-learning algorithms, i.e., mabs, are suitable for tackling decisionmaking problems in noisy and changing environments (speekenbrink and konstantinidis ) . for example, misra et al. ( ) applied an mab to a pricing problem in which the volume of demand was uncertain. schwartz et al. ( ) used an mab to improve advertising design when online advertisers were not able to identify targeted users. in our healthcare-recommendation context, service providers (e.g., online healthcare platforms) usually have little knowledge of users' healthcare needs or preferences, especially when users frequently change their behavior patterns. an mab can be used in such a setting to help service providers to effectively explore users' preference variations while improving users' online engagement during the process. in addition, through exploration, an mab increases choice stochasticity and, thus, can better promote recommendation diversity (qin et al. ) . despite these advantages, mabs are seldom studied in healthcare recommendation problems. in this study, we enrich the healthcare recommendation literature by designing an mab-driven framework for providing personalized healthcare interventions. we propose a deep-learning and diversity-enhanced mab framework for recommending healthcare interventions to address the challenges and research gaps presented in the previous section. first, we adopt an mab as the main building block of our framework, as it can effectively explore variations in users' healthcare preferences and promote recommendation diversity at the same time. to better adapt an mab to the healthcare recommendation setting, we then further enhance our framework by synthesizing two model components, that is, deep-learning-based feature engineering and a diversity constraint. as suggested by prior health studies (johnson et al. ; king et al. ; yan and tan ) , individuals' health behaviors are dynamically affected by a series of contexts, including their evolving health status, healthmanagement experiences, and social context. based on these studies, the sequential information embedded in individuals' health histories and health-behavior paths can play an essential role in shaping individuals' health behaviors. deep-learning models can effectively capture patterns from dynamic temporal sequences and extract complex synergies between different features, thereby enabling the enhanced representation of variations in individuals' health behaviors. we thus incorporate a deep-learning-based feature engineering procedure to improve recommendation personalization and contextualization. in addition, sct suggests that individuals' health management may contain multi-dimensional efforts. the diversity constraint helps us to structurally diversify recommendations along each theory-driven health-management dimension so that individuals are provided with well-rounded support. in figure , we provide a graphical illustration of our recommendation design. each construct of the recommendation framework is intended to enhance healthcare recommendation performance. in a recommendation cycle, we first use deep-learning models to construct representations for users and items, i.e., the user embeddings and item embeddings. we then use the constructed embeddings to capture the contextual features of the recommendation environment, which enables us to learn the context-dependency of the recommendation results and generalize users' feedback. the mab algorithm, shown on the right side of figure , adaptively learns users' preferences by balancing the exploitation-versus-exploration tradeoff. the diversity constraint seeks to diversify the recommendations along the theorized healthmanagement dimensions. we elaborate each of these constructs in the remainder of this section. ohcs provide healthcare interventions to encourage and instruct individuals' health behaviors. in table , we provide several examples of typical healthcare interventions provided in ohcs. we consider the setting in which an online healthcare platform provides intervention suggestions to users on a regular (e.g., weekly) basis. it is unlikely that every individual user will prefer the same interventions, and there is interpersonal heterogeneity in terms of which interventions to adopt and to what extent. the goal of the platform is to adaptively suggest k interventions with the highest chance of improving individuals' engagement in their healthcare management. formally, let t be the number of recommendation periods and i be the number of users on the platform. suppose that each time the platform provides each user with k alternatives from a full available at the end of each period, the platform receives users' feedback on the recommendations, that is, whether they have adopted or engaged in the recommended interventions. let ( , ) t r i k denote user i 's feedback on item k . users' feedback serves as a reward for the platform's recommendation decisions; the platform may use the information of users' feedback to update its knowledge about users' preferences and adjust its subsequent recommendations. we formulate the above recommendation problem as a contextual mab. in a contextual algorithm, the decision of choice is leveraged upon a set of contextual features of the environment, such as the attributes of choice alternatives and user characteristics, so that the algorithm can exploit the similarity between choice alternatives and deliver online personalized recommendations (zeng et al. ). contextual mabs learn to map the contexts into appropriate actions (greenewald et al. ). thus, they are able to personalize recommendations based on specific situations. in addition, as the pool of users and healthcare interventions may likely undergo frequent changes, it is desirable to learn a feature-based model that can generalize users' behavior histories to the user-item pairs that have never or rarely occurred in the past. to this end, in the healthcare recommendation context, we consider two sets of contextual information: individuals' health-management contexts it x and attributes of healthcare interventions k z . we assume that users' feedback, i.e., the intervention engagement decision ( , ) t r i k , is stochastically generated by an underlying probability that depends on the contexts. we model this probability as a logistic function: x z , and * θ denotes the underlying coefficient vector, which can be learned adaptively in the recommendation process. the objective for the online healthcare platform is to maximize the expected cumulative user engagement during the entire course of recommendation, i.e., ( ) modern recommendation systems should be well-diversified, motivated by the principle that recommending redundant items leads to diminishing returns on utility. in the context of healthcare recommendations, the major health-management dimensions that we identify based on sct include the outcome-oriented dimension(s) and behavior-oriented dimension(s). whereas the former helps individuals to gain outcome-driven motivation, the latter enables them to acquire health-management skills and strategies. thus, to provide individuals with well-rounded support, recommendations need to cover each of the health-management dimensions. although an mab framework is able to promote recommendation diversity through the exploration process, we further incorporate a diversity-constraint mab to ensure that the exploration is conducted in guided directions and that the recommendations are structurally diversified along each of the healthmanagement dimensions. formally, our diversity constraint can be expressed as where s denotes the recommendation set, outcome dim denotes the outcome-oriented dimension(s), and behavior dim denotes the behavior-oriented dimension(s). we subject the optimization problem in ( ) to the diversity constraint d to ensure that the recommendation set it s contains suggestions for each healthmanagement dimension. to solve this constrained recommendation task, we propose an algorithm that is adapted from thompson sampling (ts). ts is a machine-learning algorithm that addresses the exploitation-versus-exploration tradeoff presented in a bandit problem. ts is best understood in a bayesian setting in which it computes the posterior distribution of the unknown parameters θ in the likelihood function, given the realized stochastic feedback. the rationale of ts is to encourage exploration through probability matching. that is, in each round, a ts algorithm randomly draws alternatives according to its probability of being optimal. research has shown that ts generally has better empirical performance than do alternative bandit algorithms, such as ucb and e -greedy (chapelle and li ) . our algorithm extends an ordinary ts by integrating a constrained optimization problem to solve for the optimal recommendation decisions subject to the diversity constraint. we present the details of our algorithm below. a ts algorithm with diversity constraint input: prior mean j m and prior variance j u for each parameter , , , . step (optimization): solve the following optimization problem: observe a new batch of data ( , ( , )), [ ], update the posterior mean by: update the posterior variance by: recommendation size constraint binary decision to improve the characterization of individuals' health-management contexts and enhance recommendation personalization, we design a deep-learning model to construct user embeddings. specifically, our userembedding model leverages information on users' attribute features (e.g., gender, age, etc.), health-status trajectories, and health-management behavioral sequences. for each user, the attribute variables usually remain unchanged over time, whereas health status and behavioral sequences will vary with time. hence, the user embeddings depend on both user i and time t to reflect the evolving dynamics. to properly guide the learning on these aspects, we propose a novel wide-and-deep neural network. the wide-and-deep structure was originally proposed for user response modeling in mobile apps. it combines two branches of user features (i.e., a "wide" branch and a "deep" branch) to facilitate user representation learning (cheng et al. ) . in this study, we design a "wide" branch to process users' attribute features to take into account that certain intervention suggestions can be more actionable for specific users given their personal attributes, and we apply a fully-connected structure to account for possible interactions among the attribute features. we then use a "deep" branch to learn sequence features, such as users' health-status trajectories, historical healthcare-intervention adoptions, and other health-management experiences in regard to selfmonitoring activities and social behaviors. the sequence of historical intervention adoptions is included to capture the dynamics in users' preferences. together with the health-status trajectories, it captures users' evolving health histories and the corresponding changing healthcare preference. in addition, based on prior health theories mentioned in section . , health-management experiences, such as social supports and selfmonitoring activities, may also affect individuals' health behaviors and thus influence their preferences for healthcare interventions. therefore, we further include related behavior paths to capture the effect of healthmanagement experiences on users' intervention-adoption behaviors. we use long short-term memory (lstm) with a self-attention mechanism to capture the dynamically changed patterns in these features and their correlation with adopted healthcare interventions. to address the fact that different sequence features have different dimension scales (e.g., number of social activities vs. numerical intervention attributes), we propose a self-organizing lstm module and add a balancer in the lstm cell to tackle unbalanced weights between different input features. the output of the deep model is the embeddings of the adopted healthcare interventions, with the loss function defined as the cosine distance between the last hidden layer (user embedding) and item embedding. in addition, we enhance the learning process of the deep branch by an auxiliary loss function with the healthcare outcome as the goal. we use the auxiliary loss function to incorporate the effects of healthcare outcomes on individuals' health behaviors and individuals' preferences on healthcare interventions. this is unique to the healthcare recommendation context, in which individuals' health behaviors are fundamentally driven by the goal of optimizing health outcomes. meanwhile, the auxiliary loss branch can also guide the neural network to properly extract signals from the sequence features, as, otherwise, the gradient flow will not be balanced and the shallow structure will dominate the gradient flow. an illustration of the proposed deep learning architecture for user embedding construction is provided in figure . short title that highlights the main features of the intervention and a description or instruction that describes the detailed execution procedure. to capture the semantics embedded in this information, we propose a hybrid model, in which we apply lstm to learn the semantics of the intervention descriptions, and we use average token-level embedding to extract signals from the intervention titles. the outputs are the meta attributes of the intervention (e.g., duration, category, and/or intensity of the intervention). we further finetune the token-level embedding in the procedure of representation learning to ensure low information loss. in sum, the user embeddings and item embeddings help us to learn key contextual information for healthcare recommendations concerning users' health behavior contexts and item attributes, which are then used as the input of our bandit recommendation model. due to the space limit, more details on our userembedding and item-embedding models are provided in appendix a . to evaluate the performance of our recommendation framework, we collected data from a leading non- to help users to establish a healthy living style, the focal platform provides weight-loss challenges, which are behavioral treatment programs that help users to focus on a specific weight-loss goal in a short time period. examples of weight-loss challenges include diet-oriented challenges, such as "cut off processed carbs and include g of mixed veg in every meal," and activity-oriented challenges, such as " minutes of jogging every day." the diet-oriented and activity-oriented challenges provide behavioral guidance for individuals' weight-management routine. users can also find weight-loss-oriented challenges that help them to set goals directly for weight changes, such as losing a certain amount of weight during specific periods. participation in weight-loss-oriented challenges can help users to establish outcome-driven motivation. each weight-loss challenge is defined by a short title and description that contains information on the challenge goal, duration, and instructions. users can choose to join any challenge as long as its starting date has not passed. in appendix a , we provide a screenshot of the challenge webpage to show how users can retrieve challenge information from the online platform. the focal platform does not incorporate any recommendation system to facilitate users' challenge selection. during our investigation period, there were more than challenges provided to users. users may likely find it difficult to select challenges to join, as users may lack the ability to discern, from various choice alternatives, what challenges are suitable for their weight management. in addition, a significant search cost is expended, as users need to spend time reading the challenge descriptions and/or instructions before deciding which challenge to join. these problems can potentially be solved by providing personalized challenge recommendations to support healthy behaviors. our investigation on weight-loss challenge recommendations can help to improve the match between individuals and weight-loss challenges and, thus, improve individuals' weight-management performance. from the platform's perspective, the recommendations can enhance users' participation experience and, thus, contribute to user maintenance and platform sustainability. we collected three datasets to support our investigation of recommendation performance. the first dataset contains descriptive information for each challenge provided on the platform. during our data collection window, there were challenges provided on the platform in total. for each challenge, we collected the title, description, and duration. on average, users can choose from about challenges each week. the second dataset is users' challenge-selection histories; that is, we recorded for each user the challenge(s) that he or she selected per week. this dataset enables us to learn users' preferences for weight-loss challenges. the third dataset contains auxiliary information for each user, such as gender, age, membership duration, initial weight when first joining the platform, online weigh-in activities, the number of friends, and the posts published in the community forum. we use this information to capture users' heterogeneous weight-management contexts. in particular, gender and age are two factors that directly affect individuals' weight status. membership duration measures users' overall weight-management experiences on the platform. initial weight and weekly weigh-in records help us measure individuals' weight-loss status and health histories. the number of friends and forum posts provide proxies for the amount of social support available to individuals (shumaker and brownell ; yan ); thus, we use them to capture the social contexts of users' weight management. we provide a summary of key data statistics in appendix a . users on the focal platform, on average, chose two challenges per week. when users chose any challenge, they chose multiple challenges about % of the time. as noted, there are three major challenge types on the platform: weight-loss oriented, diet oriented, and exercise oriented. we find that users tend to choose different types of challenges whenever they choose multiple challenges. specifically, users choose more than two challenge types % of the time when they choose multiple challenges; they choose all three types of challenges about % of the time. these results indicate the existence of diversity in users' preferences for weight-loss challenges. in addition, we find that users' selection of challenge types drifts over time. that is, users may have preferred certain challenge types at the beginning of a time period and gradually shift to other challenge types as time goes by. these findings provide evidence for the dynamics of users' preferences, which may be due to users' transitions to different weight-loss statuses, in which they need different types of support. it is also likely that users gradually establish their personal tastes in regard to weight-loss challenges during the process of challenge participation. these findings thus provide support for our recommendation design. weight-loss challenges are presented in a textual format with a title and a description. they aim to help users to manage short-term weight-loss goals, such as changing a dietary behavior, increasing physical exercise, and reducing weight. goal setting can reinforce individuals' motivation, and well-structured goal formulation can have positive and directional effects on individuals' task performance (les macleod edd ; locke and latham ). the smart metric (i.e., specific, measurable, attainable, relevant, and time-bound) has been widely used as a gold standard in areas such as education and healthcare for assessing the quality of goals (doran ; ogbeiwi ) . this metric can help individuals to clearly identify the direction for logical action planning and implementation (ogbeiwi ; ogbeiwi ) . thus, smartrelated goal characteristics can influence how individuals perceive the effectiveness of a goal and affect their choice-making behaviors in deciding which goal to pursue. we use the smart metric to characterize each challenge based on the challenge description data. as the number of challenges is large and users' challenge-selection data are comparatively sparse, we need to quantify the similarities among challenges, and the smart-based features can properly guide our calibration of challenge similarity. in particular, corresponding to the goal-setting dimensions specified by the smart metric, we construct the following meta attributes for each challenge: whether the challenge is specifically defined (specificity), whether the challenge goal is measurable (measurability), the intensity level of the challenge (attainability), whether the challenge is related to diet or physical activity (relevancy), and the time span of the challenge (duration). in table , we provide a summary of the annotated challenge meta attributes, which will be used for learning challenge-embedding representation and downstream recommendation task. whether a challenge is specifically defined ( or ) whether a challenge goal is measurable ( or ) diet whether a challenge is related to dietary behaviors ( or ) intensity_diet intensity level for a diet-oriented challenge (l, m, h) activity whether a challenge is related to physical activities ( or ) intensity_activity intensity level for an activity-oriented challenge (l, m, h) whether a challenge contains a goal for weight changes ( or ) intensity_weight_loss intensity level for a weight-loss-oriented challenge (l, m, h) whether a challenge contains motivational words/sentences ( or ) whether a challenge requires individuals to regularly monitor and report their weightloss progress, e.g., body weight, daily diet, running mileage ( or ) duration time span (in weeks) of a challenge in addition to smart-based attributes, we consider two other features that may affect individuals' engagement in challenge participation: motivational and self-monitoring. motivational characterizes challenges from the perspective of goal statement, which has been suggested to be important in helping individuals to build up inner motivation (locke and latham ) . self-monitoring is an important step in goal fulfillment, as it helps individuals to process their performance toward goal achievement (bandura ) . we use self-monitoring to indicate whether a challenge encourages individuals to regularly monitor and report their weight-loss progress. the detailed annotation procedure is provided in appendix a . as noted in section . , our user-embedding model adopts a wide-and-deep network structure, in which we use the wide branch to capture users' attribute features and the deep branch to capture the sequence features. in our evaluation context, users' attribute features include gender, age, initial weight, and membership duration. the sequence features include three parts. the first part captures users' health status, that is, their historical weight variations. the second part is the sequence of historical challenges chosen by individuals, which we use to account for users' personal tastes. the third part concerns users' other behavioral sequences, such as their past social activities (e.g., establish friendships with other users and publish forum posts) and self-monitoring activities (e.g., weigh-in). the auxiliary loss head is designed to measure the weight loss in the next time period, where we choose a combined loss of mse for absolute value prediction and cross-entropy loss for weight-loss sign prediction. we present the detailed network structure and the loss functions in appendix a . for our challenge-embedding model, we use challenge name and description as the inputs, and the annotated challenge meta attributes based on the smart metric are the outputs. the annotated challenge meta attributes help us to depict the key characteristics of a weight-loss-related goal; thus, they provide a good standard for calibrating challenge similarity in our focal context. in operationalizing our diversity constraint, we identify weight loss as the outcome-oriented dimension, as it is the health goal that individuals aim to achieve in our focal context. we identify diet and physical exercise as two behavior-oriented dimensions, as they are two essential behavioral-regulation aspects in weight management. with respect to these dimensions, we ensure that our recommendations cover all three challenge types, i.e., weight-loss oriented, diet oriented, and exercise oriented. therefore, our diversity constraint is specified as represents the recommended challenge set, weightloss dim represents the weight-loss-oriented dimension, diet dim denotes the diet-oriented dimension, and exercise dim denotes the exercise-oriented dimension. we apply our recommendation framework to the weight-management context described in section , with the aim of promoting users' engagement in weight-loss challenges on the platform. in particular, we implement the algorithm introduced in section . to offer top-k challenges to users on a weekly basis. the time span of recommendation is weeks (i.e., the same as our data collection window). to demonstrate the effectiveness of our recommendation design, we follow the design-science paradigm to rigorously evaluate our recommendation framework through a series of experiments. we first examine the effectiveness of our deep-learning embeddings in capturing user characteristics and challenge attributes. we then apply different evaluation approaches to test each of our model components as well as to compare our model against state-of-the-art recommendation systems. to show how the construction of deep-learning models improves feature engineering, we use t-sne to visualize the embeddings in a two-dimensional space (maaten and hinton ). t-sne is a nonlinear dimensionality reduction technique that is well suited for deconstructing high-dimensional data. it can project high-dimensional vectors into lower dimensions without changing the data structure so that it helps us to understand data patterns in a more intuitive way. in a t-sne plot, two points that are close to each other indicate that the corresponding embedding representation vectors are similar. we provide the visualization results for challenge embeddings and user embeddings in figures and , respectively. specifically, we present the t-sne plot for our constructed challenge embeddings in figure ( ). in , we provide the t-sne plots for two state-of-the-art word vec deep-learning models, bert and fasttext. we use these two models as a benchmark for evaluating the performance of our proposed challenge-embedding model. in the plot, we use different colors to indicate each challenge type, such as weight-loss oriented, diet oriented, and exercise oriented. we use the color degree to denote the intensity level of a challenge: a deeper color indicates a challenge of higher intensity. for example, dietoriented challenges are denoted by orange points, and among the points, there are three color degrees: light orange, dark orange, and orange-red, representing low-, medium-, and high-intensity levels, respectively. we find that, in figure ( ), challenges that belong to the same type are tightly clustered. in addition, within each challenge-type cluster, challenges of the same intensity level tend to be close to each other. these patterns indicate that our challenge embedding model can well capture intrinsic challenge attributes, especially the ones that are key to goal-setting theory (doran ) . in comparison, the benchmark models cannot clearly distinguish these challenge patterns. ( ) proposed ( ) bert ( ) fasttext the t-sne plot for our constructed user embeddings is presented in figure ( note that these features are most directly related to our weight-loss context; in particular, gender and age are two demographics that directly affect users' body weight, and weight-loss status reflects users' in-period weight variations. we compare our proposed user-embedding model with two benchmark models, collab_learner and tabular. the results are presented in figures ( ) and ( ) , respectively. the collab_learner model and the tabular model are two encapsulated python learners provided in the fastai library. in particular, the collab_learner model learns user representations from the historical challenge-selection data; however, it is not able to incorporate users' personal characteristics. the tabular model is a deep-learning model that learns user embeddings based on users' tabular attributes, such as gender and age, but does not extract signals from sequential data, such as users' health histories and behavior paths. as shown, these two models do not perform as well as our models, as there is no explicit user pattern displayed. ( ) proposed ( ) collab_filer ( ) tabular ( ) sampled users finally, the sequence shape of the user clusters produced by our model in figure ( ) motivates us to further investigate granular individual-level patterns, as the points in a sequence are likely generated by the same or similar users. we randomly sampled several individual users and plotted their corresponding embeddings in figure ( ). we find that the embeddings of the same user locate close to each other and tend to be concatenated into a trajectory and that the embeddings of different users are located relatively far apart. these results show that our proposed user-embedding model can effectively capture the sequential we conduct an ablation analysis to compare our model with a series of baseline mabs. this allows us to show that each of our model components (i.e., the deep-learning-based feature engineering procedure and the diversity constraint) is effective in helping users to find the relevant challenges. the baseline mabs are the counterpart mab models that partially incorporate or do not incorporate the proposed model components. specifically, the baseline mabs that we investigate include the mab without user embeddings, the mab without challenge embeddings, the mab without either embeddings, the mab without diversity constraint, and the mab without either embeddings or constraint. when user embeddings are not incorporated, we use users' attribute features (e.g., gender, age, etc.) to account for recommendation personalization. when challenge embeddings are not incorporated, we use the annotated challenge features to capture the inherent attributes of challenges, namely, the variables listed in table . evaluating an explore/exploit policy is difficult because we typically do not know the reward of an action that was not chosen. possible solutions include doubly-robust estimation (dudík et al. ) , offline precision evaluated by preference set (qin et al. ) , and simulation. the first evaluation approach, doubly-robust estimation, is an offline data evaluation approach that utilizes pre-collected historical data to evaluate policy performance. the historical data are assumed to contain three sets of information: action, context, and reward. as the data are pre-collected, we are able to observe only the rewards for the chosen action in the data. to adjust for the potential bias caused by the data collection process, the doubly-robust estimator combines two policy evaluation methods, direct simulation (ds) and inverse propensity score (ips). formally, let g denote the offline dataset, which contains action a , context v , and reward r . in our context, action refers to the platform's provision of a challenge in the data, context v includes individuals' weight-management context it x and the challenge features, and r is users' feedback, that is, whether a user selects a challenge. let it s denote the set of challenges recommended to user i at week t , and it s k = . our doubly-robust estimator can be expressed as follows: where ĵ is a reward simulator, and p is the propensity of challenge provision in the data. the rationale of this method is that, when data are not available, the method uses a pre-trained reward predictor to simulate the reward; otherwise, it applies a correction to the reward predictor using the actual data. the second evaluation method measures recommendation precision. following previous studies (qin et al. ; qin and zhu ) , we construct each user's preference set as the set of challenges selected by the user in the data. the recommendation precision is thus the overlap ratio between the recommendation set and the preference set. finally, in light of previous theoretical mab studies (hertz et al. ; sani et al. ) , we examine our model performance through a simulated environment. specifically, we construct a logistic predictor for users' binary challenge-selection decisions, that is, where v is a concatenation of user embeddings and challenge embeddings. the weight vector ζ could have been chosen arbitrarily, but it was in fact a perturbed version of the weight vector trained on a randomly constructed training set (nguyen et al. ) , and the performance evaluation is conducted on a test set. this simulator is omniscient, in the sense of full knowledge of users' preferences and the actual amount of reward accrued by recommendations. we provide the details of these evaluation approaches in appendix a . the evaluation results are provided in table . each value in the table represents users' average selection rate during the entire recommendation course. a superscripted asterisk denotes that a benchmark model performs significantly worse than the proposed model. our results show that the mabs that include only one of the components have an inferior performance (i.e., lower average challenge-selection rate) than our proposed model. specifically, the mab without diversity constraint is suggested to be significantly worse by the doubly-robust estimation and simulation method. the mab without user embeddings or challenge embeddings (or both) is shown to have a worse performance by all three evaluation methods. finally, we find that the mab without either embeddings or diversity constraint performs worse than the mabs that partially incorporate the model components. these results indicate that each of our proposed model components is effective. as compared to users' attribute features, user embeddings can better capture the sequential information embedded in users' health histories and behavior paths and, thus, are more effective. challenge embeddings are more effective than the annotated challenge features, as they are able to extract semantic information from the textual challenge descriptions. in addition, as most annotated challenge features are categorical and one-hot encoded, they may not provide much information for the learning process. in comparison, challenge embeddings can better calibrate the similarity among challenges and make the learning more effective. . *** . *** . ** note: asterisk in superscript denotes that a benchmark model performs significantly worse than the proposed model. significance levels are: * p < . , ** p < . , *** p < . . in figure , we plot the recommendation performance across time to show the learning curve of each model. the x-axis denotes recommendation rounds, and the y-axis denotes the average challenge selection rate up to round t . it is shown that our model achieves the highest learning rate across all periods, regardless of the evaluation approach taken. that is, our model can boost the average challenge-selection rate faster than the benchmark models can. for example, when evaluated by simulation, our model increases the average challenge selection rate from approximately . to approximately . after the -week recommendation phase, which is a % increase. this is followed by the mab with no diversity constraint (~ %), the mab with no user embeddings (~ %), the mab with no challenge embeddings (~ %), the mab without either embedding (~ %), and the mab without either diversity constraint or embeddings (~ %). these results further highlight the effectiveness of our deep-learning-based feature engineering and diversity constraint in the learning procedure. we compare our proposed recommendation framework against a wide range of benchmark models. in particular, for benchmark bandit models, we consider ucb and e -greedy, which are two classic onlinelearning methods to solve the "exploitation-versus-exploration" tradeoff. for batch-learning-based models, we consider a variety of collaborative filtering methods, such as context-aware recommenders and matrixfactorization-based models. we also consider content-based filtering and hybrid filtering. content-based filtering is able to offer recommendations based on item features. hybrid filtering further combines content-based filtering with collaborative filtering to incorporate information embedded in users' challenge selection histories. as the batch-learning-based models make recommendations by exploiting users' itemselection histories, we use the first four weeks of data to train the algorithms. finally, we consider pure exploitation and pure exploration, which are two recommendation schemes that do not seek a balance between exploitation and exploration. we summarize our benchmark models in table . the implementation details of these benchmark models are provided in appendix a . similarly, we calibrate recommendation performance by users' average challenge-selection rate and evaluate it through the aforementioned three evaluation approaches, i.e., doubly-robust estimation, offline precision, and simulation. our evaluation results are provided in table . ( ) doubly-robust estimation ( ) offline precision ( ) omniscient simulator the results show that our proposed model has the best recommendation performance under all evaluation measures. it achieves an average challenge selection rate of . % when evaluated by doublyrobust estimation; . %, by offline precision; and . %, by simulation. ucb and e -greedy are shown to have comparable performance (~ % for doubly-robust estimation, ~ % for offline precision, and ~ % for simulation), but both perform significantly worse than our model. batch-learning-based models generally do not perform well (mainly below %). the performance inferiority may be due to users' dynamic preferences for weight-loss challenges. in other words, the batch-learning-based models assume that users' preferences can be well represented by their past behavior patterns (adomavicius and tuzhilin ; sahoo et al. ) ; thus, these models can be biased when users' preferences contain dynamic e -greedy a bandit algorithm that chooses the arm with the seemingly highest average reward with probability e and explores a random arm with probability e ; cacf context-aware collaborative filtering, which incorporates the contexts of users' item selections as weights into a normal collaborative filtering procedure (chen ) ; scf social collaborative filtering, which formulates a neighborhood-based method for cold-start collaborative filtering in a generalized matrix algebra framework (sedhain et al. ); pmf probabilistic matrix factorization, a model-based collaborative filtering approach that uses matrix factorization under a probabilistic framework to estimate user-item interactions (mnih and salakhutdinov ) ; camf context-aware matrix factorization, which is an extension of the classic matrix factorization approach for incorporating contextual information (baltrunas et al. ); cb content-based filtering, an approach to offer recommendations based on content similarities of items (bieliková et al. ; pon et al. ) ; hybrid_pure a hybrid model that combines pure collaborative filtering with cb using mixed hybridization (burke ) ; hybrid_cacf a hybrid model that combines cacf and cb using mixed hybridization; pure exploitation a model that selects the best option given current knowledge; pure exploration a model that fully randomizes recommendations. finally, our results show that pure exploitation and pure exploration achieve worse recommendation performance as compared to our model. this performance gap indicates the importance and necessity of balancing the exploitation-versus-exploration tradeoff. a pure exploitation method may be stuck in a worse local optimum. pure exploration, in contrast, over-explores users' preferences; it fully randomizes the recommendations without utilizing or learning from information embedded in users' past behaviors. note that pure exploitation and pure exploration can often be seen in the design of a/b testing. specifically, in an a/b test, experimenters first spend a short time period for pure exploration, whereby they randomly assign users to different groups to examine the performance of policy variants. they then engage in a long period of pure exploitation, assigning all of the users to the group that achieves the best performance. in practice, the pure exploratory phase can be expensive or even infeasible to implement. for example, in a health-management context, it is usually infeasible to arbitrarily assign individuals to a treatment plan. instead of two distinct periods of pure exploration and pure exploitation, a bandit-driven design adaptively combines exploration and exploitation. thus, it can reduce the opportunity cost incurred in the exploratory phase and help service providers to achieve better performance. . *** . *** . *** note: asterisk in superscript denotes that a benchmark model performs significantly worse than the proposed model. significance levels are: * p < . , ** p < . , *** p < . . in a typical healthcare context, individuals' behavior patterns likely change over time (johnson et al. ; king et al. ) . in this experiment, we investigate the recommendation results for the users whose choices tend to vary considerably as a means to examine whether our recommendation framework can well capture the dynamics in users' preferences. from the test-user set, we select the users whose challenge choices have the largest embedding variance. we implement our recommendation algorithm for the selected users and compare the recommendation performance with that of using the full test-user set. table presents the results for the new test-user set. our model is shown to outperform all of the benchmark models by all evaluation measurements. in particular, our model achieves an average challenge selection rate of . % when evaluated by doubly-robust estimation; . %, by offline precision; and . %, by simulation. to better show the performance variations, we plot the differences between the new recommendation results and the original results on the full test set in figure . here, we present the performance changes measured by doubly-robust estimation. the performance changes measured by offline precision and simulation are similar and are provided in appendix a . we find that bandit-driven models, such as our as challenge embeddings are vectors, we define the variance of embeddings as the minimum value of the variances of the elements. proposed model, ucb, and e -greedy, have different degrees of performance increase. in contrast, batchlearning-based models generally have a performance decrease. these results suggest that the advantage of the online-learning scheme is further strengthened when evaluated on the dynamic users whose preferences tend to vary frequently. the performance decrease of batch-learning-based models indicates that the "first learn, then earn" recommendation scheme may perform even worse when users' preferences exhibit strong dynamics. this may be because the dynamic patterns in users' preferences cannot be fully captured by the historical data. bandit-driven models, in contrast, are able to actively collect users' feedback on recommendations and, thus, can capture changes in users' preferences more promptly. . *** . *** . *** note: asterisk in superscript denotes that a benchmark model performs significantly worse than the proposed model. significance levels are: * p < . , ** p < . , *** p < . . performance variation for dynamic users . experiment : diversity analysis effectively learn users' diverse challenge preferences in the data. specifically, for our proposed model and each of the benchmark models, we calculate the recommendation frequency for each challenge type to construct a diversity distribution. we then compare the recommendation frequencies with users' challenge selection frequencies in the data, which reveal users' true preferences of challenge types. we use the jensen-shannon divergence (jsd) to measure the similarity between two diversity distributions (endres and schindelin ; fuglede and topsoe ) . a small jsd value indicates high similarity between two diversity distributions. in figure , we visualize the diversity distribution for each recommendation model and present the corresponding jsd values. the first bar in the figure represents the diversity distribution in users' challenge-selection histories observed in the data. the second bar represents the diversity distribution in the recommendations provided by our proposed model. as can be seen, the first two bars are very similar to each other, indicating that the recommendations produced by our model are diversified in a way that is similar to users' actual challenge-selection histories. the recommendation diversity distributions produced by the benchmark models generally have a larger difference from the observed challenge-selection data. for example, the bar that corresponds to cacf is quite different from the first bar. these observations are confirmed by our jsd results, that our proposed model has the smallest jsd value (i.e., . ) across all of the benchmark models. combined with the results in the earlier-discussed experiments, these findings provide evidence that our proposed recommendation framework can well support users' diverse healthcare preferences and that the diversity constraint can further guide the recommendation system to explore along each of the weight-management dimensions and, thus, improves learning efficiency. in this experiment, we aim to examine whether our recommendation framework can benefit more users. we define user improvement as the percentage of users who receive more preferred items from a focal recommendation algorithm than from a baseline algorithm. we use probabilistic matrix factorization (pmf) as our baseline algorithm. pmf models hidden user representations based on the users' challenge-selection histories. it does not, however, incorporate contextual information of users' selection behaviors, and it is batch-learning-based. thus, by comparing with pmf, we are able to assess the value of the recommendation context along with the online-learning scheme. we present our results for user improvement in figure . it is shown that our proposed recommendation approach has the highest user improvement rate (~ . %), suggesting that approximately % of users receive more preferred challenges from our recommendation framework than from pmf. comparatively, the other recommendation approaches have a lower user improvement rate (all below %). these results indicate that our recommendation framework can serve to improve a larger user population on the platform. the former experiments evaluate the effectiveness of our recommendation framework in improving users' challenge-selection rates. in the healthcare context, it is also important that service providers take further steps to evaluate corresponding health-related outcomes. although necessary, increasing users' engagement in interventions may not be enough, as it does not directly guarantee an improvement in health. therefore, in this experiment, we further examine our recommendation performance in improving users' weight-loss outcomes. in particular, we explore a different recommendation target: users' in-period weight-loss rate. that is, we use users' in-period weight-loss rate as feedback to guide the learning of our recommendation framework. different from prior experiments, generating weight-loss feedback requires two steps of simulation. first, we use the logistic predictor described in section . to simulate whether users will choose a particular item. second, we simulate users' in-period weight-loss status (e.g., weight gain or non-gain) based on their choices. we use users' weigh-in data to train a logistic predictor for this simulation, which takes user embeddings and the average challenge embeddings of users' choice as the input variables and users' weight-loss status as the prediction target. as shown in table , our proposed recommendation framework has the best performance under the new recommendation target, achieving an average in-period weight-loss rate of . %. in contrast, the benchmark models achieve a significantly worse average in-period weight-loss rate. these results indicate that our recommendation design is effective not only in helping users to find preferable challenges to engage in but also in further helping them to achieve better weight-loss performance. . *** pure exploitation and pure exploration pure exploitation . *** pure exploration . *** note: asterisk in superscript denotes that a benchmark model performs significantly worse than the proposed model. significance levels are: * p < . , ** p < . , *** p < . . in this study, we take a design-science perspective to develop a novel recommendation framework for providing personalized healthcare recommendations to users on online healthcare platforms. the design of our recommendation framework is motivated by several unique patterns in individuals' health behaviors. first, due to the evolving process of health management, users' health behaviors may continuously change with time. second, users may need multiplex healthcare information to manage different health aspects. these characteristics indicate that users' healthcare preferences can be dynamic and diverse. to this end, we propose a deep-learning and diversity-enhanced mab framework. mab is able to adaptively learn users' changing behavior patterns while promoting diversity along the exploration process. to better adapt an mab to the healthcare recommendation context, we further synthesize two model components into our framework based on prominent health-behavior theories. the first component is a deep-learning-based feature construction procedure, aimed at capturing important healthcare recommendation contexts, such as healthcare intervention's inherent attributes and individuals' evolving health condition and health-behavior paths. the second component is a diversity constraint, which we use to ensure that recommendations are provided in each of the major health-management dimensions, so that individuals can receive well-rounded support for their health management. we conduct a series of experiments to test each of our model components as well as to compare our model against state-of-the-art recommendation systems, using data collected from a representative online weight-loss platform. the results of the experiments provide strong evidence for the effectiveness of our proposed recommendation framework. our study contributes to the emerging literature on the application of business intelligence (abbasi et al. ; chen et al. ) . we demonstrate that prescriptive analytics can be integrated with it artifacts to generate applicable insights. in particular, the innovative healthcare recommendation framework that we developed provides an important contribution to the literature on recommendation systems and online healthcare systems. to the best of our knowledge, we are among the first to combine mab models with deep-learning-based embeddings to improve the characterization of recommendation contexts. in addition, the inclusion of diversity constraints demonstrates a way of promoting recommendation diversity according to pre-designed dimensions. this innovation can be of significance in professional industries, in which domain expertise needs to be incorporated to guide recommendation diversification. from a practical perspective, our recommendation framework can be used to address real-world challenges in healthcare recommendation problems. the effectiveness of our framework, as demonstrated by our results, implies great potential for using our recommendation design to provide users with tailored engagement suggestions. although our recommendation design is proposed for assisting individuals' engagement in online health management, the framework can be extended to broader problem settings. for example, the combination of an mab and deep-learning-based feature engineering can be used to solve other healthcare problems, such as drug discovery, disease diagnosis, clinical trials, and therapy development. decision making in such healthcare problems usually involves complex contextual knowledge (e.g., drug structures, patient health histories, symptom development paths), and decisionmakers usually do not have full knowledge of the environment (e.g., whether a drug is effective). the online-learning framework of an mab can help decision-makers to better cope with uncertainties in the healthcare environment, and deep-learning models can be combined to improve the characterization of decision-making contexts. in addition, we demonstrate a way to formulate recommendation constraints, which can be used to incorporate domain expertise to guide the recommendation procedure. our recommendation framework can also be extended to fields beyond healthcare. real-world decision-making problems, such as financial investment, product pricing, and marketing, usually contain different levels of uncertainty. the uncertainty may be because decision-makers do not gather enough data to guide their decision making, or the decision-making environment is frequently changing (e.g., market instability, technology change, policy environment fluctuation). thus, it is of practical importance to develop an adaptive decision-making framework that can respond well to the uncertainty in the environment. decision-makers may consider combining an mab with deep-learning embeddings to learn the contextdependency of their decision results while adaptively adjusting their strategies to minimize opportunity cost. in addition, in real-world recommendation problems, it is usually desirable to recommend diversified content to maximize the coverage of the information that users find interesting to improve their engagement experience. our formulation of the diversity constraint can be used to strengthen 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rosemary; mukherjee, joia; mulumba, moses; pūras, dainius; periago, mirta roses title: global health in the age of covid- : responsive health systems through a right to health fund date: - - journal: health hum rights doi: nan sha: doc_id: cord_uid: bcj y n we propose that a right to health capacity fund (r hcf) be created as a central institution of a reimagined global health architecture developed in the aftermath of the covid- pandemic. such a fund would help ensure the strong health systems required to prevent disease outbreaks from becoming devastating global pandemics, while ensuring genuinely universal health coverage that would encompass even the most marginalized populations. the r hcf’s mission would be to promote inclusive participation, equality, and accountability for advancing the right to health. the fund would focus its resources on civil society organizations, supporting their advocacy and strengthening mechanisms for accountability and participation. we propose an initial annual target of us$ million for the fund, adjusted based on needs assessments. such a financing level would be both achievable and transformative, given the limited right to health funding presently and the demonstrated potential of right to health initiatives to strengthen health systems and meet the health needs of marginalized populations—and enable these populations to be treated with dignity. we call for a civil society-led multi-stakeholder process to further conceptualize, and then launch, an r hcf, helping create a world where, whether during a health emergency or in ordinary times, no one is left behind. imagine a world where advocates successfully moved governments to greatly increase health systems funding and ensure that those health systems were equitable and of good quality, and where civil society and the public could monitor progress and hold their governments accountable. health systems would be well resourced and universally accessible, and they would have sufficient numbers of health workers operating in environments safe for themselves and their patients. imagine that advocacy and broad public and government understanding of people's right to water and sanitation accelerated efforts to enable all people to follow good hygienic practices. and imagine that participatory policymaking, empowered community-based organizations, and regular, open dialogues with policy-makers led to trust in health information from both governmental and nongovernmental sources. in short, imagine a world where health rights advocacy received robust support, and the core right to health principles of equality, accountability, and participation were being realized. it would have been a world better prepared to meet the immense health and social demands of the coronavirus disease (covid- ) pandemic. and it could yet be a world that is ready to meet the next outbreak of a novel or emerging infection. when vaccines are developed, as they will be, and made available to everyone, covid- will slowly recede into the past. yet the weak health systems, lack of sufficient hygiene, and frequent lack of trust in health and political authorities that contribute to the toll of infectious diseases will remain. as will the regular toll of disease and death these take because systems are not in place to protect people's health, especially that of the marginalized among us. for as of , more than half of people globally were not covered by essential health services. what is more, over a quarter of people globally did not have access to basic sanitation ( ), % lacked access to drinking water ( ), and slightly more than % did not have enough food to eat ( ). the united nations political declaration on universal health coverage reaffirms the human right to health. yet, more than years after the universal declaration of human rights, with so many states failing to deliver quality health services to all, will still another commitment to the right to health make a difference? global pledges can be transformative, but only particularly as countries respond to and begin to recover from covid- , with its tremendous economic and social harm, it might be too big a political lift to expect the creation of a global fund for health on the multi-billion-dollar scale required to create universal health systems, however needed such a fund may be. but imagine the potential impact if the responses to covid- and the political declaration on universal health coverage led to a right to health capacity fund (r hcf) focused on strengthening civil society's ability to advocate for the right to health, as well as fortifying the mechanisms to achieve this right-including inclusive participation, accountability, and equality. imagine how this could help secure health for all and better prepare the world for the next disease outbreak. inclusive participation is critical for ensuring that health policies and programs are attuned to the realities of communities, and it empowers people to advocate for their own health. meaningful participation respects human dignity and agency, a major contribution to well-being, and can promote affordability, accessibility, and quality. accountability requires political leaders to answer for their failures in delivering universal health coverage (uhc). equitable health systems leave no one behind, evincing special concern for marginalized populations. an r hcf could be a foundational component of a reimagined post-covid- global health infrastructure. and it would become a powerful counterweight to nationalist populism, breathing life into the right to health, and helping restore the mutual solidarity that is ever more urgent as the world confronts the pandemic and its aftermath. a right to health capacity fund the r hcf's mission would be to promote inclu-sive participation, equality, and accountability for advancing the right to health. funds would be directed to civil society, especially community-based organizations, to build their capacities to advocate for health rights and strengthen mechanisms to increase accountability and participation (see box ). these vital health funding needs receive only a miniscule proportion of health funding (discussed below). reasons include funders' preference for supporting direct health services and not sufficiently appreciating the contributions made by advocacy efforts and accountability and participation mechanisms to improved health; a narrowing civil society space, including fundraising restrictions on human rights organizations; the sometimes oppositional nature of advocacy; and governments' reluctance to share decision-making powers or to be held accountable. beyond this core focus, the r hcf might directly support health services provision for highly marginalized populations who continue to be left behind (see box ). the line between these two sets of activities might sometimes seem blurry; guidance on eligible activities will need to be clear. the r hcf would aim to enable even the most marginalized populations to fall within the ambit of uhc, and it would advance the social determinants of health, including nutritious food, clean water, sanitation, safe housing, education, and gender equality. the r hcf would concentrate on entities with the least access to global health financing: community-based and grassroots organizations, and other civil society organizations. while the r hcf would focus on lower-income countries (where health indicators are the worst and where each dollar could go the furthest), funding would also be available to civil society organizations in higher-income countries, since extreme disparities and marginalization exist there as well. as governments may themselves need right to health capacity building, civil society organizations and developing country governments could partner to jointly access funds to strengthen the capacity of governments and national human health and human rights journal rights institutions, such as through educating legislators and judges on the right to health. partnerships with the government will also be key to sustaining programs that should receive government financing, such as multi-stakeholder participation and accountability mechanisms, right to health education, and any direct services for marginalized populations that the r hcf supports. the r hcf could develop a set of principles to prioritize grant-making, including activities that benefit especially marginalized populations, are likely to create sustained change, and are least likely to secure alternative funding. we envision the r hcf as an independent nonprofit organization modeled on the gfatm, gavi, and unitaid, perhaps based in the global south, where most of the communities whose rights it supports would be located. its governing structures could include governments, civil society, international institutions, and foundations. civil society and community leaders would have a leading role in r hcf governance. governments on the board would have to be committed to the right to health. both civil society input and objective assessments advocacy • human rights organizations' advocacy, policy analysis, and strategic litigation • right to health advocacy training for community members community-based and -driven accountability and participation • local health service and other social accountability measures, such as village health committees and health facility monitors participatory policymaking • community-driven health impact assessments for policies, programs, and projects that affect the right to health, whether adversely (such as mines, fossil fuel subsidies, and deforestation) or positively (such as parks, public transportation, and healthy school meals) • participatory health planning to ensure that urban and other community designs promote health for all and that pandemic preparedness plans protect marginalized populations • participatory budgeting for health-related budgets • participatory processes to develop health equity programs of action* right to health capacity building • community members' and civil society organizations' capacity to participate in health policymaking processes • right to health literacy and education, including for community members, public officials, health workers, educators, judges, lawyers and paralegals, law enforcement officers, and journalists • partnerships between legal services organizations and health providers to increase patients' understanding of their rights and their access to justice • information exchanges on successful right to health advocacy strategies • government capacity to enforce standards on quality, non-discriminatory, acceptable, and accessible health care in the private sector and to carry out environmental safety testing and enforcement in marginalized communities • national human rights institutions' capacity to investigate and resolve complaints about right to health violations legal empowerment • access to justice programs to support claims centering on the right to health monitoring • right to health monitoring, such as through national human rights institutions, parliamentary right to health investigations, and community platforms • public expenditure tracking of health-related budgets in addition to funding activities such as these, the r hcf could have targeted strategic initiatives. these could include supporting innovative mechanisms for accountability and participation and accelerated grants for right to health emergencies. the r hcf could also reserve a small sum for technical support aimed at helping smaller organizations strengthen their financial systems and monitoring and evaluation capacity and ensure that their programming is well designed and based on best practices. such support would help these organizations overcome key barriers to their effectiveness, namely limited capacity and experience, along with their simply having insufficient funds. † the r hcf could be either independent or housed within an existing organization, where it could gain efficiencies by leveraging the organization's administrative, communications, and other expertise and infrastructure (such as financial auditing). one potential host organization could be the robert carr fund, which strengthens civil society networks that support the health and rights of inadequately served populations-though it is focused regionally and globally, with a particular emphasis on hiv. another option is the gfatm, although its existing governance would pose challenges, among them that only three of twenty gfatm board members are from civil society and affected community. whether independent or linked to an existing organization, the r hcf could become part of a consortium of interested right to health funders. collaboration could enable them to best compen-sate for their respective limitations, share lessons, develop a joint evidence base, and share resources, such as technical guidance and expertise. like other global health funding mechanisms, the r hcf would be funded through contributions by governments, foundations, and other donors. the gfatm and other health funds may even choose to offer a small solidarity contribution, given the r h-cf's contributions to their own missions. in addition, an innovative financing window would help ensure the fund's viability and sustainability, and could be inspired by several countries' dedicated airline ticket tax to support unitaid. innovative funding for the r hcf could come, for example, from willing governments levying a tax on goods, services, or profits of corporations whose activities undermine the right to health, including tobacco, alcohol, sugary beverages, and highly processed unhealthy foods. even a very low tax rate could raise significant sums. many governments already tax certain unhealthy products. filling the gap: the size of the r hcf currently, data are insufficient to accurately estimate existing funding levels for civil society right to health advocacy and other functions that the r hcf would fulfill. indeed, the absence of should a secondary function of the r hcf be to directly support health services for neglected populations? the r hcf could prove a literal lifeline for politically marginalized and stigmatized populations by funding, for example: • syringe exchanges for users of injected drugs • mobile health clinics to bring health care to remote, rural villages • clean water for indigenous communities • community health centers for vulnerable migrant populations • community-based support for people with disabilities however, such funding would have drawbacks and risks. direct support for health services would reduce already inadequate funding available for the fund's core mission-civil society action and structural changes advancing participation, accountability, and equality. further, health services that depend on the r hcf might not be sustainable. governments might even use the r hcf as a justification for not providing these services themselves. if the r hcf were to support direct services provision, it could be accompanied by measures to mitigate these concerns, such as agreements with the governments of countries receiving this funding on co-financing and on gradually assuming and sustaining domestic funding responsibilities, ensuring a sense of ownership. data highlights the importance of the r hcf. it is frequently said that we measure what we value; the lack of data suggests a low global priority. we recommend that such assessments be carried out. nonetheless, the data points that do exist suggest both a paucity of funding and a considerable unmet need. first, the gfatm is the main multilateral funder of right to health activities, with a strategic objective to "promote and protect human rights and gender equality" and with an unprecedented breaking down barriers initiative aimed at removing human rights barriers to hiv, tuberculosis, and malaria services. yet between the countries that were part of this initiative and other human rights grants secured through the ordinary grant process, the gfatm invested only about $ million toward human rights in - , or approximately us$ million per year. while countries exceeded the gfatm's target that middle-income countries allocate at least . % of hiv grants to breaking down human rights barriers, only . % of tuberculosis grant funding addressed human rights, below the gfatm's % target. beyond the gfatm, funding is sparse. major foundations such as gates, rockefeller, and ford do not focus on the right to health. the open society foundations is the most significant foundation funder of human rights activities, with us$ million spent on health and human rights activities in . the robert carr fund, operating on a threeyear funding cycle, provided nearly us$ million for - . the largest foundation focused exclusively on frontline human rights activism is the fund for global human rights, which currently provides grants totaling us$ million annually. only us$ million in development assistance went to nongovernmental women's organizations per year in - , including a mere us$ million annually for those in developing countries. a comprehensive review found that us$ million was available to civil society organizations in latin america from to for human rights activities-only % of which was for advocacy and lobbying. limited bilateral right to health funding is focused on sexual and reproductive health rights-vital, yet only one of many needs. it is apparent, then, that right to health funding is far below existing and future needs. we envision an r hcf with an initial annual target of us$ million, which would represent a transformative infusion of new funds. while we believe that this is a reasonable target, it is not based on a rigorous data-driven assessment. the r hcf could adjust its funding target based on demand and research to better understand the right to health funding landscape. the economic case: the power of rights while it might not seem it during the wave of multi-billion and even multi-trillion dollar covid- rescue packages, in ordinary times, even us$ million per year would be considered a significant investment. what is the case for the r hcf, then, including in light of the alternative of simply increasing direct health system investments? first, the r hcf would be far more achievable than a health systems fund that could have a major global impact. while we strongly support massive new investments in health systems, a transformative r hcf is possible at a much lower price. a us$ million annual fund would vastly scale up resources for the right to health. by contrast, billions of dollars annually will be required to make significant inroads into filling health systems gaps: the funding gap to achieve the targets of the third sustainable development goal (sdg), which is focused on health and includes uhc, is at least us$ - billion per year for low-and middle-income countries, with % of investments needed for health systems. second, the r hcf would valuably complement current domestic and international health investments. it would enhance accountability, contributing to policies that ensure the most effective and efficient use of funds, and it would ensure that policies and programs are developed through inclusive participation, tailored to people's needs and realities. third, advocacy can leverage new money, particularly increases in national health budgets. this is especially important because the vast majority of funds for health systems and underlying determinants of health will come from domestic resources. fourth, right to health initiatives can be transformative. for example, a study in uganda reported that using community score cards-a form of community monitoring of local health services that includes an action plan that community members and health workers develop jointly-led to a % reduction in child mortality. a grant from the fund for global human rights was critical in securing tunisia's first law on domestic violence. the treatment action campaign's social mobilization and litigation led south africa to offer antiviral treatment for people living with hiv. fifth, even with vastly scaled-up health systems funding, without dedicated efforts, marginalized populations will likely be left behind. civil society's ability to document rights violations, develop sharp analyses and recommendations, mobilize political constituencies, generate media attention, bring neglected perspectives to lawmakers, and seek accountability through courts can drive policy reform and resource allocation that new health systems funding alone might not. even with significant new health system funds, an r hcf would be critical to ensure health coverage that is truly universal and that systems are in place to protect marginalized and other vulnerable populations during disease outbreaks. finally, the r hcf would contribute to human dignity in ways that strengthening health systems alone cannot. it would enable people to be active agents in decisions affecting their health and lives, and to be respected. the value of enabling people at the margins to experience being treated with dignity is incalculable. the chief obstacle to an r hcf is the political will to create it. creating a new international right to health financing mechanism of significant magnitude is a tall order. the global recession that the covid- pandemic will cause will make funding scarce in the near term. yet the global health community has demonstrated strong interest in innovative new financing models, such as the pandemic emergency preparedness facility and the coalition for epidemic preparedness innovations. and a powerful constituency would advocate for the r hcf. there is a growing body of evidence-including case studies, randomized control trials, literature reviews, and the forthcoming mid-term assessment of the global fund's breaking down barriers initiative-on the public health impact of funding advocacy and other health and human rights programming. and in time, the r hcf could contribute to this evidence, with regular publications on the impact of its investments, including toward rights-based uhc and global health security. the high-level political commitment to uhc and the commitment to improving global health security that will surely follow covid- open a window of opportunity for the r hcf, which would make major contributions to sdg -from accountability and participation to advocacy that unleashes significantly increased and more effective domestic health funding. in an era of nationalistic populism, civil society space is narrowing and the world is experiencing an erosion of human rights, including through growing xenophobia and discrimination. the fund could be of major interest to countries that remain deeply committed to human rights, the rule of law, and global solidarity. funders might view the r hcf as a powerful antidote to the nationalism and lack of global collaboration that is almost surely worsening the harms of covid- , from too little funding for lower-income countries to the global scramble to find manufacturers of medical equipment and supplies and win the international bidding war, rather than sharing scarce supplies equitably and based on need. the added urgency of human rights, combined with a renewed commitment to uhc and global health security, could make the r hcf a compelling possibility. and there is a global constituency to support it-communities whose health rights are not respected, and civil society seeking to push for the right to health. we envisage civil society organizations undertaking meticulous policy j u n e v o l u m e n u m b e r health and human rights journal analysis, doing sustained lobbying, and campaigning in the streets to create a r hcf. we hope for the support of major global institutions, such as the world health organization and the office of the united nations high commissioner for human rights, given that the r hcf would support their core missions. the path ahead accordingly, we call on other civil society advocates, international organizations, governments, and foundations to join us in a multi-stakeholder process, one led by civil society and that includes current right to health funders, to conceptualize the r hcf, to advocate for it, and to create it. the need to, as united nations secretary-general antonio guterres has put it, "recover better" from covid- , together with the political declaration on uhc, provides a vital window of opportunity to launch the fund rapidly. if the transformative sdg agenda and the promises to achieve uhc by and to leave no one behind are to be more than lofty declarations, we cannot wait to develop a powerful r hcf. international fund for agricultural development, united nations children's fund, et al., state of food security and nutrition in the world united nations general assembly global fund to fight aids, tuberculosis and malaria framework convention on global health alliance achieve health equity: crafting national programmes of action for the sdg era freedom house, freedom of the world research methodology about the robert carr fund unaids - strategy: on the fast-track to end aids global fund to fight aids, tuberculosis and malaria, office of the inspector-general, advisory review: removing human rights-related barriers: operationalizing the human rights aspects of global fund strategic objective (geneva: global fund to fight aids who we are: financials innpactia and civicus, access to resources for civil society organisations in latin america: facts and challenges (innpactia and civicus financ ing transformative health systems towards achievement of the health sustainable development goals: a model for projected resource needs in low-income and middle-income countries power to the people: evidence from a randomized field experiment on community-based monitoring in uganda hope in action: funding frontline advocacy around the world pathways to accountability in rural guatemala: a qualitative comparative analysis of citizen-led initiatives for the right to health of indigenous populations improving social accountability processes in the health sector in sub-saharan africa: a systematic review available at https://www.who.int/ news-room/detail/ - - -shortage-of-personal-protective-equipment-endangering-health-workers-worldwide. . a. guterres, "'this is, above all, a human crisis that calls for solidarity key: cord- -xeue p authors: armour, cherie; mcglinchey, emily; butter, sarah; mcaloney-kocaman, kareena; mcpherson, kerri e. title: the covid- psychological wellbeing study: understanding the longitudinal psychosocial impact of the covid- pandemic in the uk; a methodological overview paper date: - - journal: j psychopathol behav assess doi: . /s - - - sha: doc_id: cord_uid: xeue p the covid- psychological wellbeing study was designed and implemented as a rapid survey of the psychosocial impacts of the novel severe acute respiratory syndrome coronavirus (sars-cov- ), known as covid- in residents across the united kingdom. this study utilised a longitudinal design to collect online survey based data. the aim of this paper was to describe ( ) the rationale behind the study and the corresponding selection of constructs to be assessed; ( ) the study design and methodology; ( ) the resultant sociodemographic characteristics of the full sample; ( ) how the baseline survey data compares to the uk adult population (using data from the census) on a variety of sociodemographic variables; ( ) the ongoing efforts for weekly and monthly longitudinal assessments of the baseline cohort; and ( ) outline future research directions. we believe the study is in a unique position to make a significant contribution to the growing body of literature to help understand the psychological impact of this pandemic and inform future clinical and research directions that the uk will implement in response to covid- . the psychosocial effects of the severe acute respiratory syndrome coronavirus (sars-cov- ), otherwise known as covid- are pervasive and of significant societal concern. indeed, it is likely that covid- will not only affect the mental health of the population presently, as the pandemic spreads, but that the impact may last long into the future. we would expect that many individuals will experience a rise in mental distress symptoms, such as anxiety and depression, during these unprecedented times when populations have been required to drastically change their day to day way of life. however, there is further concern that for some, particularly those with pre-existing vulnerabilities, this rise in mental distress will reach clinically significant levels and in turn affect day to day functioning. this is expected due to the rapidly changing and uncertain situation that is covid- and the very real fears that people will have for themselves and others around infection and mortality. previous research on sars, mers and h n (swine) flu, have given insight into the psychological impact of the outbreak of an infectious respiratory disease and the measures taken to curb its spread. a high degree of psychological distress was reported during such pandemics, particularly among healthcare workers, quarantined individuals, and sars survivors and their family members (brooks et al. ; gardner and moallef ; maunder ; tsang et al. ) . moreover, recent research from the initial phases of the covid- outbreak in china has suggested that there has been a significant psychological impact on the general population (qiu et al. ; wang et al. ) . in response to the covid- pandemic, the uk governments put in place several restrictions as the situation progressed. on january st , the first coronavirus case was confirmed in the uk (exactly month after the first covid- case was detected in wuhan, china). on march th , who declared covid- a pandemic. on march th the coronavirus bill - was introduced in the house of commons. on march rd , the uk prime minister boris johnston announced severe restrictions (enforceable by police), including a need for the population to stay at home unless there was an absolute necessity to leave such as shopping for food, medical emergencies, or if required to work in a government designated keyworker role (a comprehensive timeline from . . - . . can be found in mcbride et al. ; pre-print) . on april th the uk lockdown was extended for "at least" another weeks. however, by this time both wales (april th ), ni (april th ) and scotland (afternoon of april th ) had separately announced extensions to the lockdown beyond the initial three-week period. by may th , the uk's death toll was the highest in europe and the second highest in the world. on may th the uk prime minister announced an initial easing of lockdown restrictions. in this address, those in england who could not work from home were "actively encouraged" to return to work (avoiding public transport if possible and if not possible to social distance and wear face coverings), an unlimited amount of outdoor exercise was allowed, and individuals could drive to outdoor destinations. however, the administrations with scotland, wales and ni chose not to adopt the 'stay alert' strategy brought forward by the uk prime minister and set out their own plans on easing lockdown restrictions. from may th both the scottish and welsh governments eased restrictions to allow more than once daily exercise. no other changes were made to the lockdown restrictions in scotland; however, wales began opening gardening and recycling centres. the ni executive agreed a similar three-week extension and permitted garden and recycling centres to reopen (may th ). furthermore, ni also began recommending use of face masks in enclosed spaces (may th ), a measure announced in scotland weeks earlier (april th ). while there are plans in england to begin opening schools by june st , wales, scotland and ni have all indicated that schools will likely not open until the new academic year. additionally, a phased strategy to ease lockdown restrictions was outlined by the prime minister on the may th . however, the implementation of each of the phases involved in easing the population out of lockdown and the opening of various business and places is subject to continuous review based on the most up to date information regarding the virus. it is important to mention each nation within the uk differs regarding their individual phased strategy regarding the removal of lockdown restrictions. at the initiation of lockdown (march rd ), covid- deaths had been officially reported across the uk (england: , wales: , scotland: and ni: ). by the time the covid- psychological wellbeing baseline survey closed (april th ), official figures stated that , covid- deaths had taken place across the uk (england: , , wales: , scotland: , and ni: ) . at the time of writing this manuscript (may th ) there have been , covid- deaths in the uk (england: , , wales: , , scotland: , and ni: ) . moreover, as of may th , when adjusting for population, the uk had the highest rate of daily confirmed covid deaths worldwide ( day average), approximately people per million per day (our world in data ). the government restrictions, coupled with an already increasing prevalence of mental ill health in the uk (ford and mcmanus ; mcmanus et al. ) , and a known adverse psychological impact of restrictions such as self-isolation; which intensify loneliness and reduce sense of connectedness, purpose and meaning in personal lives, has the potential to accelerate the prevalence rates of mental ill health across the uk. in recognising this, a team of leading mental health scientists published a position paper detailing a number of mental health research priorities for the uk in response to the covid- pandemic. these included the need for increased monitoring and reporting of the rates of mental health issues and a need to determine the factors that adversely or positively affect mental health during this time. from a public health perspective, these priorities focused on the general population as well as specific populations (holmes et al. ) . in line with the research priorities highlighted by holmes et al. ( ) , the covid- psychological wellbeing study assessed commonly occurring mental health disorders such as anxiety and depression among all participants. furthermore, following the traumatic impact of previous outbreaks (maunder ; maunder et al. ; wu et al. ) , posttraumatic stress symptoms were measured, and, given the nature of the study and prior research having highlighted that quarantined and infected individuals and their family please note that these figures refer to deaths of people who had a confirmed positive covid test result. the actual number of deaths as a result of covid are likely much larger; the official figures, cited here, do not include individuals who had not been tested at the time of their death, those who tested positive from a non-nhs or public health laboratory, those who initially tested negative but subsequently caught the virus and died without a subsequent positive test and, as an indirect result of the virus, as seen in the large numbers of excess deaths during this time. furthermore, it is also important to note that small differences in the numbers of deaths recorded are present depending on where and when the data were sourced. there can be delays in a death occurring and it being reported in the official statistics for a number of reasons (e.g. awaiting test results). thus, the figures presented here are those that the department of health and social care had recorded by that date. subsequently these figures were revised to include additional deaths that had taken place by that date but had not been officially recorded as covid deaths. https://coronavirus.data.gov.uk/about members were at increased risk of poor mental health (brooks et al. ; gardner and moallef ; tsang et al. ), we also queried specific covid- exposure experiences. separate from mental health difficulties, a range of more practical concerns related specifically to the pandemic, such as adherence with government advice, concerns about school closures, governments perceived efficiency, job security, financial implications, the capacity of the health service, and infection concern were examined. such concerns, while distressing themselves, may also contribute to a deterioration in mental health and wellbeing. individuals who are concerned about becoming infected or about the availability of healthcare may be at risk of developing health-related anxiety or obsessive health behaviours (abba-aji et al. ; asmundson and taylor ; blakey and abramowitz ; jungmann and witthöft ) . individuals suffering from a job loss or financial instability as a result of the pandemic may be at greater risk of developing a range of mental health issues (mental health foundation ). moreover, the substantial changes to daily life as a result of lockdown restrictions has added stress to many individuals' work and family lives (e.g. school closures forcing parents to homeschool their children while working from home themselves). such disruption to normal routine, activities and livelihoods may lead to increases in depression, loneliness, self-harming and suicidal behaviour, and harmful alcohol and drug use (who ). finally, the role of media consumption in amplifying distress was included; this was subsequently highlighted as a mental health research priority (holmes et al. ) . as previously mentioned, it is important to identify groups of individuals who are most at risk of poor mental health during this time in order to help guide experts and to formulate an appropriate, proportionate response to these needs. indeed, older individuals and those with physical health problems may be at risk of more severe outcomes if infected with coronavirus and thus may also experience greater levels of concern and distress (holmes et al. ; shevlin et al ; preprint) . individuals with prior and current mental ill health concerns may have exacerbated distress due to disruption in services and increased isolation (elovainio et al. ; holmes et al. ) , and individuals with lower incomes or financial instability may have less access to technology (hernandez and roberts ) and more difficult housing situations (eurostat ) . the covid- psychological wellbeing study therefore investigated a range of sociodemographic characteristics to help understand which groups were potentially the most psychologically impacted. the primary aim of this paper is to report the study protocol and the resultant sociodemographic characteristics of the participants of the covid- psychological wellbeing baseline survey. for completeness, although never the intention, the sample proportions will be mapped to the uk adult population proportions (using data from the census). this will allow readers to determine areas where the sample data approximates and thus represents the uk general population and areas where particular sociodemographic may be over-and/or under-represented. our secondary aim was to provide a clear and concise account of the data that has been collected across the uk population and sub-divided by uk nation (england/wales, scotland, and northern ireland). we aim to conclude with a summary of the ongoing efforts for weekly and monthly longitudinal assessments of the baseline cohort. the covid- psychological wellbeing study is a longitudinal, multi-wave online survey of the adult ( years +) general population of the uk. the study was designed to rapidly assess and monitor the psychosocial impact of the covid- pandemic on uk residents. this was achieved by implementing an online survey; launched on march rd and closed on april th . participants who completed the initial survey were asked to complete follow up surveys on a weekly basis for three weeks (from their completion of the baseline survey [baseline as t + t = week , t = week , t = week ]) and then at three monthly intervals post baseline survey completion [baseline as t + t = month , t = month , t = month ]). this study design result in four waves of weekly longitudinal data during the first month of the uk lockdown and four waves of longitudinal data during the -month period from the st day of the uk lockdown. the former allows us to track mental health outcomes during an intense period of lockdown when restrictions were at their height and the latter allows us to track mental health outcomes over a longer period in which lock down restrictions are eased. participants were recruited via two avenues ( ) a large-scale social media campaign and ( ) using an online participant panel called prolific. all participants were required to be + years or older, currently resident in the uk and able to read and write in english. no other exclusion criteria were applied. participation was voluntary. those who participated via social media recruitment activities were included into a prize draw for one of six £ vouchers. participants who joined the study via prolific received between £ . and £ . depending on survey length across baseline and follow-ups. data collection commenced on march rd . this timeline corresponds with the commencement of the uk's period of lockdown whereby the uk prime minister announced that all people were required to stay at home except for specific and essential reasons to leave (march rd ; see timeline above). the survey was administered entirely online through the survey data collection platform 'qualtrics'. the study was launched initially via a variety of social media platforms (twitter, facebook). additional data was collected using a panel of uk residents hosted by prolific (https://www.prolific.co/). all participants, regardless of recruitment mode were required to complete the baseline survey. all those recruited via social media were asked to complete follow up surveys on a weekly basis for three weeks and then at monthly intervals ( month, months and months). participants recruited via prolific were asked to complete the monthly follow up surveys only due to a lack of financial resources that would have been required for such extensive weekly surveys. as surveys progressed, certain topics were added to the survey battery to answer key political and scientific topics of interest and therefore there are additions to measures and topics assessed across weeks and months. for the purpose of this paper, we focus on all measures included in the baseline data as completed by all participants. all participants received a detailed participant information sheet outlining the purpose of the study, exact details concerning participation, how information would be stored, what would happen to the information concerning onward publication of the data and the results, and the risks and benefits associated with participation. participants were informed about confidentiality and under what circumstances confidentiality would be broken. likewise, they were informed that participation was voluntary and they were free to refuse to participate at any point and therefore free to refuse to complete further surveys. participants were informed that if they wished to withdraw they had to contact the chief investigator with their email address and mobile telephone number used for the study and request that no more reminders about participation were sent to them. they were informed that the decision to withdraw would bring no negative consequences to them nor affect their relationship with the researchers, support providers, or queen's university. they were additionally provided with details on the formal complaints procedure, contact details for the researchers, ethical approval, and where they could access the most up-to-date information concerning covid- . subsequently, participants were presented with statements, which they had to confirm in order to provide full consent to participate in the study. all study procedures were in accordance with gdpr. personal contact data was separated from the survey responses and replaced with a unique identifier. personal contact data is stored in a separate database and access is restricted to two members of the research team. all data will be fully anonymised prior to being shared across researchers in the team. ethical approval for the covid- psychological wellbeing study was provided by the ethical review panel in the faculty of engineering and physical sciences at queen's university belfast (reference: eps _ ) and also glasgow caledonian university health and life sciences ethics committee, (hls/ pswahs/ / ). we are grateful to professor brendan murtagh (the chair) and additional reviewers for their rapid review and approval of this study. a number of quality control measures were applied to the survey to help ensure the authenticity of responses and screen out those did not meet the inclusion criteria. the survey was firstly piloted by the research team as a measure of quality control (n = ) before going live on social media and prolific. individuals were removed from the data if; (i) the respondent clicked into the survey link but did not complete any measures (n = ), (ii) the respondent did not provide full informed consent (n = ), (iii) the respondent did not provide information relating to the inclusion criteria (i.e. age and/or current residency; n = ), (iv) the respondent did not meet the inclusion criteria (i.e. < years or non-uk resident, n = ), (v) the respondent completed the survey in less than the minimum completion time (n = ). minimum completion time was set at s ( min, s), half of the median completion time for the sample. a series of standardised self-report measures were included in the survey. many were included in full, whereas some were included in part. the survey also included newly created questions pertaining to covid- exposures, worries, and symptoms. furthermore, we included a series of questions related to social and traditional media engagements around covid- news. this study was devised in early march and therefore there were no standardised measures available covering the covid- pandemic. to ensure our questions were robust and reliable several academics reviewed them in full and suggested modifications based on the extant knowledge of covid- at the time. this knowledge was based on reliable and trusted sources such as public health england, the national health service, and the world health organisation. these modifications were incorporated in full for the final survey. further details are below: participants provided information regarding their gender, age, marital status, ethnicity, religious status, personal income, and their highest level of educational attainment. female participants were asked to specify if they were currently pregnant. participants were also asked to provide information related to education and employment and to indicate whether they themselves or their family members were working in one of the government assigned key worker roles. if they indicated that a family member was a key worker, they were also asked to indicate if they lived as part of the same household. participants were asked several questions based on their residential status. specifically, their place of residence, residence type ('house', 'room in a shared house', 'apartment/ flat', 'student halls', 'residential home' or 'other), urban vs rural ('isolated dwelling', 'hamlet', 'village', 'small town', 'large town', 'city'), and number of bedrooms in place of residence. they were also asked to best describe their housing situation ('owned outright', 'owned with mortgage', shared ownership', rented', 'living rent free' or 'other'). finally, participants were also asked to specify the number of adults over years and children under years present in their place of residence, and whether they currently owned any pets (and were asked to specify what type or types of pets they had). the survey queried whether participants had ever suffered from a physical or mental health related concern. specifically, asthma, heart disease, cancer, diabetes, shortness of breath, post-traumatic stress disorder, major depressive disorder, phobia, social phobia, obsessive compulsive disorder, generalised anxiety disorder, psychotic disorders, eating disorders, health anxiety or another kind of chronic condition not specified. covid- living status participants were asked to indicate their current living status in relation to covid- at the time of completing the baseline survey ('i am living as normal', 'i am not self-isolating but have cut down my usual activities as a precaution', 'i am not self-isolating but have been told to work from home', 'i am self-isolating as i do not want to get ill, but i am not high risk, 'i am self-isolating as i do not want to get ill, but i am regarded as high risk', 'i am self-isolating as i do not want others to get ill', 'i have been told to selfisolate due to possible symptoms of covid- ′, 'i have been told to self-isolate due to a diagnosis of covid- ′, or 'i have been ordered by the government or local authority to selfisolate/stay home'. participants were presented with a series of questions in relation to symptom expression, testing, diagnosis (for themselves or loved ones) and exposure to covid- related deaths. specifically, they were asked (at the time of survey completion) did they know someone who currently has or had in the past been quarantined for covid- due to exposure and whether any of these people have been close family members or friends. likewise, they were asked to indicate did they know someone who currently has or had in the past been diagnosed with covid- and whether any of these people have been close family members or friends. participants were also asked to indicate if they were a carer for someone who had been diagnosed with covid- . participants were also asked whether they themselves were currently in quarantine or had been in quarantine in the past due to covid- , whether they had self-isolated in order to avoid infection and whether they were regarded as 'high risk'. participants were also asked if they had self-isolated due to government advice and whether they had self-isolated because they had symptoms. participants were also asked whether they themselves have been tested for covid- and whether they had been diagnosed with covid- . two questions pertained to whether participants had received a flu vaccination in the past year and whether they had had the flu in the past year. participants were also asked about exposure to covid- related deaths, specifically whether they had experienced the death of a close friend or family member and whether they had been exposed to covid- related deaths due to their occupational role. finally, participants were asked to indicate whether they experienced any of the following symptoms ('fever', 'cough', 'sore throat', 'headache', 'cold symptoms' or 'no symptoms') at the time of survey completion. media/information consumption a number of questions queried participants' media consumption in related to covid- . specifically, they were asked how often they were watching, reading, and hearing reports or updates about covid- on social media, on traditional media and on a dedicated app that has been set up to provide covid- updates. the possible response categories in relation to each type of media consumption were, ( ) less than once a day, ( ) - times a day, ( ) - times a day, ( ) - times a day, ( ) - times a day. and ( ) more than times a day. participants were asked to indicate how worried they were about several covid- related concerns. specifically, worries around quarantine/self-isolation, being infected with the virus by others, infecting others with the virus, stigmatisation due to exposure, job security, the financial implications of the outbreak, food shortages, the government's ability to manage the outbreak, the healthcare systems ability to care for covid- patients, border closures and the impact of school/university closures on children and young adults. each of these responses were rated on a likert scale, ranging from ('not at all') to ('extremely'). finally, participants were asked to indicate if they thought school, university or border closures were necessary. trauma exposure prior trauma exposure was assessed using the life events checklist for dsm- (lec- ; weathers et al. a ). the lec- contains items measuring trauma exposure and therefore the measure is used to assess whether an individual has been exposed a ptsd 'criterion a' traumatic event. in the current study we added an additional event of 'coronavirus'. participants were asked if any of the stressful life events, as measured by the lec- (plus our single addition), ever happened to them. the possible response categories were 'yes' or 'no'. participants were asked to keep their answers to the trauma screen in mind and indicate which event they felt was the worst. the possible options were, 'natural disaster'; 'fire or explosion'; 'transportation accident'; 'serious accident at work, home, or during recreational activity'; 'exposure to toxic substance'; 'physical assault'; 'assault with a weapon'; 'sexual assault,'; 'other unwanted or uncomfortable sexual experience'; 'combat or exposure to a war zone'; 'captivity'; 'life threatening illness (not covid- )'; 'witnessing severe human suffering'; 'sudden violent death'; 'sudden accidental death'; 'serious injury, harm, or death you caused to someone else'; 'coronavirus'; 'other'; 'none'. previous research has highlighted excellent psychometric properties of the lec- (gray et al. ). ptsd was assessed with the ptsd checklist for dsm- (pcl- ; weathers et al. b) . the ptsd checklist contains items reflect the dsm- symptom criteria for ptsd. in this study, participants were asked to think about their responses in regard to their covid- related experiences. these items are organised into one of four clusters each reflecting a different aspect of ptsd symptomatology. these clusters are 'intrusions', 'avoidance', 'negative alterations in cognition and mood' and 'alterations in arousal and reactivity'. each item of the pcl- is rated on a five-point likert scale (' = not at all' to ' = extremely'), and asks participants to indicate how much each symptom bothered them over the past month. a participant must rate a given item (or symptom) as ' = moderately' or higher in order to constitute as valid endorsement of a symptom. in order to meet the criteria for a diagnosis of ptsd, there must first of all be trauma exposure, followed by valid symptom endorsement across each of the ptsd symptom clusters. according to the dsm- , this requires valid endorsement (a score of or higher) of at least, one 'intrusions' item, one 'avoidance' item, two 'negative alterations in cognition and mood' items and finally, two 'alterations in arousal and reactivity' items (american psychiatric association [apa] ). additionally, previous empirical research suggests that a total score on the pcl- of between is indicative of 'probable ptsd' (murphy et al. ) . in line with the research outlined above, if a respondent had a score of or above on the pcl- they were classified as reporting 'probable ptsd'. a wealth of previous literature has demonstrated the excellent psychometric properties of the pcl- across various populations (blevins et al. ; bovin et al. ; weathers et al. b; wortmann et al. ) . generalised anxiety disorder the generalised anxiety disorder scale (gad- ; spitzer et al. ) is a seven-item scale (gad- ) used to measure symptoms of generalised anxiety disorder. the scores across all seven items are summed to yield a total score, with higher scores indicating higher levels of severity (range - ). the scale asks participants to reflect on the past two weeks in answering each of the seven items, with each item ranging from (not at all) to (nearly every day). furthermore, across both adult and adolescent samples, scores on the gad- have also been used to define severity of anxiety-based symptoms (spitzer et al. ) . a score of - is considered none/normal levels of anxiety, - is considered mild, - is moderate and - is severe (spitzer et al. ) . in adult samples scores of or more may be of particular clinical concern, as they are likely to meet the diagnostic criteria for an anxiety disorder. using the threshold score of , the gad- has a sensitivity of % and a specificity of % for gad (spitzer et al. ) . therefore, in the context of this study scores of or above were considered indicative of those meeting the criteria for gad. previous literature has demonstrated the excellent psychometric properties of the gad- across various clinical and non-clinical populations (kertz et al. ; lee and kim ; rutter and brown ; spitzer et al. ) . the patient health questionnaire (phq- ; kroenke et al. ) , was used to measure symptoms of major depressive disorder. the phq- asks participants to reflect on the past two weeks in their response to nine items, which are based upon the dsm-iv diagnostic criteria (apa ) used to assess mdd symptomatology, namely, sleep, fatigue, concentration, low self-esteem, anhedonia, etc. however, it also is in line with the current dsm- criteria (apa ; burdzovic and brunborg ) . each item of the phq- is scored on a -point likert scale, ranging from to . the response categories were, not at all ( ), several days ( ), more than half the days ( ) and nearly every day ( ). each item is summed to yield a total score, with a possible range of - , with higher scores reflecting greater levels of mdd. furthermore, scores on the phq- have also been used to define severity of mdd symptoms. in adults, a score of - none or mild, - is considered minimal, - is considered moderate, - is moderately severe, and ≥ is severe. furthermore, in adult samples scores of ≥ or more may be of particular clinical concern, as they are likely to meet the diagnostic criteria for an mdd. using the threshold score of ≥ , the phq- has a sensitivity of % and a specificity of % for mdd (kroenke et al. ; levis et al. ; manea et al. ) . therefore, in the context of this study scores of or above are considered as meeting the criteria for mdd. the phq- has been strongly supported for its applicability as a short screening tool (burdzovic and brunborg ) across various clinical and non-clinical contexts and support the psychometric validity of the scale (allgaier et al. ; burdzovic and brunborg ; lee et al. ; levis et al. ; titov et al. ; umegaki and todo ) . sleep quality participants were asked to rate what the quality of their sleep in general. the response categories were 'very good', 'fairly good', 'fairly bad' or 'very bad'. further participants were asked how they would rate their sleep quality as a result of the coronavirus (covid- ) situation during the past month. again, the response categories were 'very good', 'fairly good', 'fairly bad' or 'very bad'. emotional dysregulation the difficulties in emotion regulation scale-short form (ders-sf; kaufman et al. ) was used to measure deficits in emotional regulation. the ders-sf was developed from the original -item scale (ders, gratz and roemer ) . the ders-sf contains items rated on a -point likert scale, ranging from to . items , and are reverse coded. the response categories were, 'almost never' ( ), 'sometimes' ( ), 'about half of the time' ( ), 'most of the time' ( ), and 'almost always' ( ). the measure yields a total score as well as scores on six sub-scales. each subscale reflects a different aspect of emotional dysregulation. these are ( ) 'non-acceptance', ( ) 'difficulties with goal directed behaviour', ( ) 'impulse control', ( ) 'lack of emotional awareness', ( ) 'lack of clarity' and ( ) 'limited access to emotional regulation strategies'. higher scores indicate higher levels of dysregulation. in comparison to the original -item form, ders-sf has been shown to have excellent psychometric properties, with internal reliability values for both the ders-sf total scale and six subscales ranging from . to . in the original validation study (kaufman et al. ) . additionally, kaufman et al. ( ) indicated correlations between the ders and ders-sf ranged from . to . and indicated that the ders and the ders-sf shared - % of their variance. loneliness the ucla three-item loneliness scale (hughes et al. ) was used to measure subjective feelings of loneliness among the sample. the ucla item loneliness scale contains three questions derived from the full-scale ucla loneliness scale (version ; russell ) . each item measures one of three key dimensions of loneliness, ( ) social connectedness, ( ) relational connectedness and ( ) selfperceived connectedness. the response categories are ( ) 'hardly ever', ( ) 'some of the time' and ( ) 'often'. higher scores across these items reflect higher levels of loneliness. the excellent psychometric properties of the both the long and short forms of the ucla loneliness scale are well documented (hughes et al. ; russell ) . additionally, participants were asked to indicate how often they felt lonely, using the same response categories as above. this was a bespoke question. social support the perceived social support questionnaire-brief form (kliem et al. ) was used to assess participants perceived level of social support. the measure contains items which are rated on a -point likert scale ranging from ('not true at all') to ('very true'). higher scores reflect higher levels of perceived social support. previous research supports the psychometric validity of the scale across a range of diverse populations (kliem et al. ; lin et al. ) . the meaning in life questionnaire (mlq; steger et al. ) was used to measure the presence of and pursuit for meaning in life. the mlq contains items which correspond to one of two dimensions of meaning in life ( ) 'presence of meaning' (which refers to the extent to which participants feel that their lives have meaning), and ( ) 'the pursuit of meaning' (this refers to the extent to which participants try to find meaning and understanding in their lives; steger et al. ) . each item is rated on a -point likert scale ranging from ('absolutely true') to ('absolutely untrue'). our analytic plan, for the current paper, was conducted across three complimentary phases as follows: ( ) a series of descriptive analyses were conducted to present an overview of the key sociodemographic characteristics of the entire sample (n = ) for the baseline data of the covid- psychological wellbeing study. ( ) a series of descriptive analyses were conducted to present an overview of the key sociodemographic characteristics by uk nation. ( ) the sample distributions of key sociodemographic variables were examined in comparison to recent uk population distributions (gleaned from census data) by uk nation of residence; these were age, gender, ethnicity, economic activity, and household composition. the covid- psychological well-being study was designed as a rapid data collection exercise across the uk population. this work was supported in part by funds from the school of psychology at queens university belfast in northern ireland and the department of psychology at glasgow caledonian university, in scotland. the recruitment target was participants in baseline. the total response rate was and after several exclusions were applied concerning data quality control (please see above methods section) the final effective sample size was participants. table displays the key sociodemographic characteristics across both the overall sample (n = ) and by each nation. both england and wales were combined in order for census comparison (see table ). overall, the majority of the sample were female (n = ; . %). additionally, the majority of the sample were white (n = ; . %). further, the majority of the sample were employed full time (n = ; . %) and stated that they were not religious (n = ; . %). diversity was evident in relation to age, household income, marital status and educational attainment. in order to assess the representativeness of the covid- psychological wellbeing study sample to the uk general population, it was compared to data from the uk census for adults aged years + . in some cases, where estimates for those and older were not available, alternative comparisons were made (e.g. + or + years). these are noted in the table footnotes section. specifically, the sample was compared by uk country of residence, gender, ethnicity, economic activity, household composition, age and education level. although this method is inexact due to changes within the population in the past decade, the census contains publicly available information on all sociodemographic variables of interest. these results are presented in table , modelled on that of mcbride et al. ( ; preprint) . results are presented across the uk nations, however, in line with the census statistics, information on england and wales are presented together. in brief, the covid- psychological wellbeing study sample was not representative of the uk population as a whole (by country of residence) or within the uk nations (by sociodemographic characteristics). respondents from scotland and ni were oversampled in the study while those from england/wales were underrepresented. within each nation, females were oversampled and males under-sampled, particularly those from scotland and ni. ethnicity comparisons revealed that this was the variable which most closely represented the ethnic profiles across the uk nations. economic activity was difficult to compare to the census statistics due to the survey methodology. within the survey, respondents were able to endorse multiple options related to their employment and studying. as such, respondents could report being employed and a student, or being employed parttime and being self-employed. however, a crude comparison to the census data suggests that employed individuals and students were oversampled, while those who are unable to work or are retired were undersampled. this was similarly reflected in age group comparisons; younger individuals (particularly those aged - ) made up a greater proportion of the sample than expected from the population estimates, while there was a substantial deficit in the number of older adults (particularly those aged years +) within the sample. as noted by mcbride et al. ( ; preprint) , an accurate comparison of household composition was not achievable from the ni census data. however, the household composition of england/wales and scotland was similar to the census estimates. table displays summary statistics regarding the housing conditions and composition of the covid- psychological wellbeing study respondents (n = ). overall, the majority of the sample lived in a city (n = ; . %). regarding housing conditions, the majority of the sample lived in a house (n = ; . %), owned their place of residence with a mortgage (n = ; . %) or rented their place of residence (n = ; .%). in terms of housing composition, majority of respondents stated at least two adults lived in their home (including them; . %). further, most of the sample did not have any children under the age of in their place of residence (n = ; . %). finally, almost half of the overall sample did not own a pet (n = ; . %), with diversity evident across those who did own pets. table displays summary statistics regarding keyworker classification for the entire sample (n = ) and by each nation. overall, . % (n = ) of respondents stated they were employed within one of the government assigned key worker roles at the time of survey completion. of these respondents, majority were keyworkers in the area of health and social care (n = ), followed closely by education/childcare (n = ). this was consistent across each of the nations. the purpose of the current study was to provide a technical overview of the design and procedures involved in initiating the covid- psychological wellbeing study. furthermore, details of the measures utilised in the baseline survey and the sociodemographic characteristics of the sample are presented. given the expected widespread impact of the pandemic and its associated impact on mental health, the survey was implemented rapidly to allow for a comprehensive assessment of changes in mental health as situation unfolded within the uk. as previously mentioned, the current study was designed around key research priorities as identified from previous epidemic and pandemic research (e.g. sars), the broader literature surrounding the impact of traumatic events and consideration of topical issues that were of public interest. moreover, the focus of the covid- psychological wellbeing study aligns well with a recent report published in the lancet psychiatry (holmes et al. ) . although this position paper on mental health priorities during the covid- pandemic was published after the current study had been launched, many of the key areas identified by the authors are covered. holmes et al. ( ) identified a number of immediate and long-term mental health research priorities both at an individual and a population level. the nature of the current study will allow for opportunities to focus on some of these priorities, namely, monitoring and reporting of common mental health problems, identifying groups who are particularly vulnerable to psychological distress at this time, determining the mechanism which underlie these mental health problems (i.e. risk and protective factors), ascertaining the longer term consequences of the pandemic across the population and within vulnerable groups, and investigating the effect of repeated pandemic-related media consumption on mental health. such research can inform the design and development of a range of appropriate digital interventions both a population level and bespoke interventions for specific groups of individuals. mental health services have been highlighted as an essential part of governments' responses to covid- (united nations ). the uk government has published a recovery strategy for covid- (uk government ) which acknowledges the potential impact of these recent societal changes on the nation's mental health. although the strategy promises improvements to, and funding for, health and social care settings in order to facilitate safer access to services in future (e.g. delivering service digitally), at the time of writing, no specific uk mental health strategy for covid- has been put in place. a range of mental health campaigns have been launched, however, for example, every mind matters (public health england ), how are you doing? (public health wales ), clear your head (scottish government ), while the department of health in ni launched a mental health action plan (department of health ) in response to covid- on may. it is clear that a focused mental health strategy will be needed in light of the current pandemic, either uk wide or across nations. longitudinal research, such other) and are therefore not included in this comparison. please not participants were given to option to state they did not want to disclose their gender, these were excluded from the above as that of the current study, may help inform these strategies and campaigns by highlighting key areas of attention or concern and specific groups who are experiencing the most distress. the current study has many strengths, particularly in respect to study design. firstly, a large range of variables (sociodemographic, psychological, health, etc.) were covered in the initial baseline survey and followup surveys. this will yield a vast and diverse amount of information which can be used to help garner a better, more comprehensive understanding of the impact of these unique circumstances longitudinally. indeed, the topics covered within the survey were empirically derived, based on previous epidemic and pandemic research and matched many of the research priorities previously mentioned. for example, holmes et al. ( ) identified at least eight groups of individuals who may be particularly vulnerable to experiencing mental distress at this time, such as front line workers, people on low income or those with financial insecurities, children and young people, etc. therefore, the large range of sociodemographic topics covered will allow for a wide-ranging investigation of at-risk groups. additionally, psychometrically valid and frequently used measures of anxiety, depression and ptsd were included in the study which may aid future comparisons. furthermore, although no specific covid- measures were available at the time of survey design, the covid- specific items were based on reliable sources of covid- information (e.g. who) and were reviewed by several academics before being included in the study. moreover, the research team acted rapidly as the covid- context evolved to ensure topics which had not been included within the baseline survey, but subsequently became areas of interest or research priorities (e.g. attitudes towards vaccines), were included within the follow-up surveys. the multi-phase survey design aimed to facilitate a comprehensive data collection strategy and was an additional strength to the study. data were collected intensively from survey launch; all respondents completed the baseline while approximately half completed weekly follow-up surveys for the next month. this was followed by three anticipated monthly follow-up surveys for the full sample. this strategy allows for a comprehensive overview of mental health and wellbeing for the first month of the lockdown period in which most people's daily lives had changed dramatically, and also for an investigation of the more nuanced findings over time and as restrictions eased in the following months. finally, as openly acknowledged throughout, this study did not aim to collect representative uk sample. however, efforts were made post-data collection to assess the degree of representativeness within and across the uk nations. although ultimately the data was not representative, a substantial number of responses were gathered from england, scotland and ni, while few came from wales. as such, a more diverse uk sample was collected in relation to country of residence and at the time of writing, this is the largest known data collection exercise on covid- and mental wellbeing in ni. a number of limitations are important to consider in the context of the current study. arguably, the main limitation of the study is that the data is not representative of the uk population as a whole, in terms of country of residence, or of the individual uk nations in terms of their sociodemographic characteristics. therefore, the findings may not be generalisable to the wider uk population as a whole. however, as discussed above, there were certain strengths unique to the aims of the study by oversampling those from northern ireland and scotland. it is also important to note that the data pertaining to the current study is modest in nature as compared to some ongoing data collection efforts in the uk (fancourt et al. ) , but similar in sample size of others . the aim of the covid- psychological wellbeing study was to collect data on participants. this decision was based on the fact that the research was being conducted in the absence of external funding and the research team chose not to apply for external funding. additionally, while the utilisation of online survey methods was deemed the only safe way to gather such data on a large scale amidst a pandemic and has the added benefit of increasing accessibility to those groups who would be difficult to access via other means (wright ) , it is also important to mention that our sampling strategy may result in self-selection bias (bethlehem ) . all participants involved in the current study were recruited via a social media campaign or via prolific panel data, each of these options requires the participant ( ) to opt in first of all and ( ) have access to an internet connection and equipment to take the survey online. therefore, specific groups may be underrepresented because they do not have an internet connection, computer/smartphone device, social media profile or simply do not wish to take part in the research (bethlehem ) . given the unprecedented nature of this pandemic, it is important to also mention a number of important risk factors and experiences that were not queried in the baseline survey. we did not examine general physical health and exercise, abuse or maltreatment within the home, interpersonal violence, more in depth exploration of specific disorders such as ocd, health anxiety or diabetes nor peoples experiences of medical care if required for a covid diagnosis. of note, we did query note: a n = participants in the scottish sample had missing data across these variables and were therefore excluded; b n = participants in the n.i sample had missing data across these variables and were therefore excluded; c participants could choose more than one pet and n = participants has missing data across the entire sample for this question 'how worried people were about the ability of the health system to care for coronavirus patients if the situation worsens'. a large proportion of respondents were 'extremely' worried about this (n = ; . %) or quite a bit worried (n = , . %). given the nature of the pandemic, the researchers were responsive to covid- topics of public and scientific interest and inserted additional topics into future waves of data collection; for example attitudes to a covid- vaccine (if one was to become available) and problematic drinking behaviours. regarding the questions in the survey itself, it is possible that participants, when asked about 'self-isolation', may have had different interpretations regarding the specific meaning, either due to their own personal understanding or the rapidly changing government guidance as the situation progressed. finally, all measures used in relation to the current study were self-report, therefore it cannot be ruled out that the respondents may have been influenced by their willingness or indeed unwillingness to report correctly, which therefore may potentially bias the results (weiss et al. ). since the implementation of the baseline survey on the march r d substantial progress has been made. regarding the respondents who were recruited via the social media campaign, a further follow up surveys have been completed ( week, week, week and month post baseline completion). all respondents recruited via prolific have also now completed a month and month follow up survey. the circumstances surrounding this pandemic are rapidly changing and individuals are constantly adapting to change and challenges in their lives and routines: distancing from loved ones, working from home, job losses, and at times inability to grieve in the usual way. it is likely that the lasting effects of this pandemic may not become apparent until months down the line, or they may fluctuate in peaks and troughs in relation to key events. for example, a spike in poor mental health following lockdown and an ease in covid- concerns and worries with time (c prc ; fancourt et al. ) . it is therefore imperative that longitudinal and prospective research is prioritised in order to map these changes across the uk. in order to address this, as aforementioned, the covid- psychological wellbeing study aims to conduct both weekly and monthly follow-up surveys in order to provide a thorough investigation of how the mental health and wellbeing of individuals has been impacted by ( ) the outbreak itself, ( ) the first month of the lockdown period and ( ) the period following the ease of lockdown restrictions, allowing for more nuanced study. additionally, it is essential such research aims to embrace and investigate the complexity of studying mental health and none of these -i am not a keyworker . . . . a n = participant within the scottish data had missing data and therefore was excluded from the data presented; b n = participants form the n.i data has missing data and were therefore excluded from the data presented wellbeing during these unprecedented times. therefore, not only studying causal links but also the mechanisms that influence the relationship between certain risk factors and mental health problems, e.g., social isolation and loneliness, emotional regulation, coping strategies, certain demographic risks such as living alone, financial and employment concerns etc. furthermore, certain groups of individuals may need specific examination (e.g. parents, key workers, those who are shielding etc.). future research should strive to collect data allowing crossnation comparisons within the uk. this will be of interest given that various government bodies have taken different approaches within the four nations and there are varying precovid social, economic and cultural differences across the uk nations; some of which have the potential to impact on population wellbeing. moreover, this extends to cross-country comparisons given countries have varying approaches to lockdown restrictions and the ease of these restrictions. the covid- psychological wellbeing study affords the opportunity to make viable cross-country comparisons with partners in the us, israel and australia because of collaboration on and direct sharing of the study protocol and measures with incountry investigators who are undertaking their own data collection efforts. given these unprecedented times, qualitative research exploring the unique lived experiences of particular vulnerable/at risk groups such as those with pre-covid mental health concerns or those working on the front line is essential. the covid- psychological wellbeing study has acknowledged this need and has recently launched a sister qualitative study -'the caring for the covid- carers, key workers, and their families study'. this study aims to understand the perceptions and experiences of both healthcare professionals and their family members during the outbreak of covid- . at present, the data collection is nearing completion and a separate paper will be published in due course outlining the methodology and research findings regarding this. in sum, the covid- psychological wellbeing study aims to rapidly assess and monitor the psychosocial impact of the covid- pandemic on uk residents. at the time of writing, this is the largest known data collection exercise on covid- and mental wellbeing in ni. given the focus on both a quantitative longitudinal multi wave design, and a sister qualitative study we believe this programme of research is in a unique position to make a significant contribution to the growing body of literature to help understand the psychological impact of this pandemic. data availability the participants did not give consent for their data to be made publicly available. derived data supporting the findings of this study will be made available from the corresponding author on reasonable request. conflict of interest no potential conflict of interest was reported by the authors. ethical approval ethical approval for the covid- psychological wellbeing study was provided by the ethical review panel in the faculty of engineering and physical sciences at queen's university belfast (reference: eps _ ) and also glasgow caledonian university health and life sciences ethics committee (hls/pswahs/ / ). consent to participate all participants involved in the current study provided informed consent. the authors affirm that all participants provided informed consent for the findings to be published. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and 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jurisdictional claims in published maps and institutional affiliations acknowledgements the authors would like to thank each and every participant who gave up their valuable time to complete this survey during this pandemic. additionally the authors are grateful to the members of the ethical committee for their rapid review and approval of this study.author contributions ca designed the study. ca and em obtained ethical approval and collected the data. em and sb conducted the analysis and the write up of results. ca wrote early drafts of the manuscript. all authors contributed to the write up of the manuscript and various draft revisions. additionally all authors reviewed and approved the final version. key: cord- -lzwyaq y authors: khodayari-zarnaq, rahim; alizadeh, gisoo; kabiri, neda title: global health diplomacy: a closer look date: - - journal: iran j public health doi: nan sha: doc_id: cord_uid: lzwyaq y nan outbreak of some diseases such as hiv/aids, severe acute respiratory syndrome (sars), and ebola virus has created a demand for making appropriate policies and diplomatic coordination in the international level and has turned international health to the core component of foreign policy in the recent decades ( ). peter bourne, jimmy carter's special advisor for health affairs, introduced "medical diplomacy" for the first time in . improvements in international communications between policy makers and researchers changed this concept to "global health diplomacy", the concept which contains performances of public and private actors in order to improve global health ( ) . "global health diplomacy" was applied operationally in , when european unions had come together for coordination of some diseases like cholera, plague, and yellow fever ( ). there are different definitions of "global health diplomacy" in the literature. one of the most comprehensive definitions relates to adams and novotny ( ) in which global health diplomacy is a political change in order to achieve intrinsic goals of health promotion through strengthening international relationships especially in areas with resource constraints. health diplomacy was noted as a means to protect you in the global society as well as an opportunity for bridging gap among governments, private sector, and non-governmental organizations in order to improve public health ( ). in recent decades, some health policies have succeeded in increasing political reputation or improving relations between states and political actors. among these programs as soft power, some countries as china and cuba send a large number of physicians to the african countries. establishment of hospitals and health care centers in these countries is another type of soft power policies ( ) . given the importance of health in sustainable development, health diplomacy needs to be one of the main tools of foreign policy in countries. moreover, health diplomacy should be considered more increasingly by governments to achieve their superior health goals in their societies. global health diplomacy: a critical review of the literature defining health diplomacy: changing demands in the era of globalization the globalization of public health: the first years of international health diplomacy global health diplomacy health diplomacy: a prescription for peace the authors declare that there is no conflict of interests. key: cord- -ut uxu d authors: nan title: errata date: - - journal: environ health perspect doi: nan sha: doc_id: cord_uid: ut uxu d nan the statistical examination of the fallon childhood cancer cluster by steinmaus et al. ( ) provides renewed justification for opening a larger window onto the expanse of possibilities regarding a possible cause for this extraordinary cluster. although the cause(s) might very well be the culmination of simultaneous or sequential exposure to an array of chemical stressors (perhaps in conjunction with nonchemical stressors) at the needed concentrations for sufficient time and during critical windows of vulnerability (as dictated by health and nutritional status, age, sex, genetic susceptibility, etc.), it is worth considering possible new, plausible singular causes until each is ruled out. significant resources have been devoted to investigating the childhood cancer cluster discovered in in fallon, nevada (churchill county). although the magnitude of this cluster of acute lymphoblastic leukemia (all) could be attributed to happenstance, the recent analysis by steinmaus et al. ( ) shows that such a cluster would be expected to occur in the united states by chance less frequently than every , years. a surprising, contemporaneous incidence of all also developed in sierra vista, arizona (cochise county health department ) . other clusters have occurred in several additional western u.s. rural communities, as well as in various locales worldwide. of possible significance has been the simultaneous emergence in both churchill and cochise counties of an extremely rare form of childhood cancer, rhabdomyosarcoma. none of the hypothesized causes of the fallon cluster has withstood scrutiny (with the possible exception of an unknown infectious agent-the "population mixing" hypothesis or "kinlen theory," although not supported by the examination of steinmaus et al. ) , including exposure to arsenic, tungsten, radiation, and jet fuel. any hypothesis must account for the important fact that these clusters seem to be limited to a span of several years, after which the incidence subsides. another commonality seems to be arid agricultural locales that experience periods of drought. surprisingly, despite the extensive resources and time devoted to searching for an environmental etiology, no consideration has been devoted to one potential cause that would account for many, if not all, of the aspects of these clusters. pyrrolizidine alkaloids (pas) comprise a complex galaxy of highly bioactive natural products. riddelliine, senkirkine, monocrotaline, retronecine, heliotridine, jacoline, jacozine, jacobine, seneciphylline, and senecionine are but a few of the numerous pas produced by a wide spectrum of plants. pa-producing plants (e.g., tansy ragwort, coltsfoot, hound's tongue), especially senecio species, have long been problematic in the western united states and are well known for livestock poisonings. fluctuating levels of pa contamination in the consumer food supply, especially via certain herbal teas (e.g., comfrey), honey (beales et al. ) , dairy products, beef, and grains, are a function of drought and harvest or foraging conditions, and therefore exhibit aperiodic cycles of high expression. churchill county happens to be the center of honey production in nevada (churchill co. ; michigan state university extension ) ; honey is also produced in cochise county. honey has been a particular focus for pa contamination; levels can vary from hive to hive by two or more orders of magnitude within the same foraging location and by time of year. pa-producing plants are particularly prevalent in both counties, where they can contaminate the domestic food supply as weeds; some, such as comfrey, continue to be sold by certain vendors of nutritional supplements and health foods. sporadic acute exposures or long-term exposure to low levels (e.g., as little as µg/day) of pas can lead to delayed toxicity (australia new zealand food authority ; molyneux et al. ) (up to or more years after exposure) and could therefore escape causal suspicion or elude measurement. levels of metabolites insufficient for overt toxicity in adults could be passed from mothers to fetuses and nursing infants. maternal transfer would also exempt the liver as the major target for the well-documented toxicity for these chemicals. furthermore, all can originate in utero (jensen et al. ) . although best known for their hepatotoxicity (where the bioactive metabolites, such as the dehydropyrrolic products, lead to veno-occlusive diseases and cirrhosis), activated pas can elicit significant genotoxicity and can be carcinogenic as well as anticarcinogenic (which has led to their experimental use in chemotherapy). some pa adducts persist in tissues from which metabolites can be released, even long after initial exposure, and migrate to other tissues or can be transported to fetuses or nursing infants (molyneux and james ). it is noteworthy that honey, milk, and grains are also common foods for infants. although carcinogenicity data are lacking in humans, pas have been shown in rats to cause both leukemia (chan et al. ) and rhabdomyosarcoma [california environmental protection agency (epa) ] . the food and drug administration (fda ) , the national toxicology program (ntp ) , the world health organization (who ) , the california epa ( ) , and others have identified pas as a major human health threat, especially for fetuses and infants. significantly, a recent study (jensen et al. ) points for the first time to a link between maternal diet and all, where consumption of carotenoids and glutathione (via vegetables) is proposed as being protective. although linkages of cancer with diet often ascribe the cause to deficiencies or insufficiencies of essential or protective nutrients, just as likely would be the presence of particular chemical stressors-anthropogenic and natural toxicants alike. this finding of jensen et al. ( ) fits nicely with the fact that glutathione conjugation in particular is known to be a major detoxification route for pas. a coordinated investigation by epidemiologists, toxicologists, and environmental chemists of a pa-leukemia linkage could prove to be a prudent investment. the author declares he has no competing financial interests. henderson, nevada e-mail: daughton@gmail.com . as a toxicologist of nearly years, a private consultant, and associate editor of the international journal of toxicology, i am concerned that although silbergeld's assertions on the risk of arsenic residues in poultry are presented under the cloak of good science, they appear to be her personal opinions and not a scientific conclusion based on sound methodology and evidence. in her letter i found at least three significant deviations from sound scientific methodology. these included the multiple mischaracterization of results presented in other publications and the introduction of a serious mathematical error. i will discuss in detail only one of these, the mathematical error, which should suffice to demonstrate the lack of science supporting silbergeld's opinion letter. in one of the articles silbergeld relied upon, "mean total arsenic concentrations in chicken - and estimated exposures for consumers of chicken" by , the authors estimated that, based on the consumption of g/day of chicken meat, an average individual may ingest . - . µg/day inorganic arsenic. however, in employing these numbers in her letter, silbergeld stated the units erro-neously and reported the results of laskey et al. as . - . µg/kg/day inorganic arsenic. this single error inflated the alleged "exposure" rate by , %, a significant miscalculation. in fact, this error, by itself, completely negates silbergeld's opinion that inorganic arsenic exposure through the consumption of chicken "would be a significant addition to drinking water exposure." this misquoting of lasky et al.'s ( ) results is but one of silbergeld's significant mistakes in her letter. the result of each error of this type is either an inflation of the calculated exposure or a buttressing of silbergeld's stated opinion. as a long-time author, reviewer, and editor of scientific papers, i am aware of the difficulty in ensuring the detailed accuracy of manuscripts, particularly where letters are concerned. there is a historical, although incorrect, perception that letters deserve less review than full manuscripts. at the same time some individuals, knowing that letters are not peer-reviewed to the same degree as scientific articles, make use of letters to get into print content that would otherwise not be acceptable. although this may not have been the objective of silbergeld's letter, her scientifically unsupported opinion was repeated in the baltimore sun (o'brien ) and other media (e.g., consumer reports ) as though it were scientifically proven fact. the result was unnecessary public alarm based on unsupported personal opinions. peer-review is meant to identify and weed out mistakes of this type. ethical journals either require authors to correct errors before publication or decline to publish the article if the author refuses to make the warranted changes. peer-review is not only the job of the publishing journal, but also the institution where the author resides (in this case, johns hopkins university). at many institutions, anything intended for publication must withstand internal review by an institutional committee before it can be sent to a potential publisher. for some reason, neither institutional nor editorial review detected these misquoted results and mathematical errors, a number of which appear to be obvious and would have been easily detected had the letter been checked. both the journal and institution may wish to review their current procedures and make adjustments so they are not similarly embarrassed in the future. as professionals, health scientists must be cognizant that respectability and trust are fragile commodities. we all know too well of a number of professions in our society that have lost significant amounts of respect and trust (e.g., politicians, lawyers, clergy) because of the misuse of the trust placed in them. rational thought, balanced and unbiased evaluation, and honest report-ing, as exemplified by the scientific method, are the primary underpinnings of the trust with which the nonscientific community honors us. anything that causes loss of that trust, whether sloppy work or biased, selfserving presentations that distort the true state of scientific knowledge, demeans us all. the author is a consultant for alpharma, the manufacturer of roxarsone, an organic arseniccontaining drug approved by the food and drug administration (fda) for use in chicken and pigs. he has also, in the past, worked for the fda, the regulator of this compound. the author's other clients include the national academy of science, the national institutes of health, the department of defense, and numerous private companies. washington, dc e-mail: bernard@sra-intl.com editor's note: lasky et al. were given the opportunity to respond to silbergeld's letter [environ health perspect :a -a ( ) ], but they declined; we omitted that fact when we published silbergeld's letter. bernard comments on the calculations in my letter to criticize my conclusions, which were that the use of arsenic for growth promotion in poultry feeds results in contamination of chicken products (and other food animal products because of the use of poultry litter in feeds), and that the estimates of risk have not been adequately calculated, even by because of unsubstantiated inferences of the arsenic concentrations in edible tissues and a puzzling use of outdated risk assessments for arsenic. i find it interesting that bernard (who has consulted for the food and drug administration, the agency that permits this nontherapeutic use of arsenicals in animal feeds) does not comment on these conclusions in his letter. i acknowledge the error in quoting ; i used the wrong metric in quoting her conclusions. please do not ascribe responsibility to my colleagues, who environmental health perspectives • volume | number | april read this letter in manuscript form, or to ehp's editorial office. however, i do not agree that this mistake invalidates the conclusions of my letter. if the concentrations of arsenic in edible chicken meat are not onetenth of those in liver (as claimed by alpharma, the manufacturer of roxarsone), then the exposure of americans who consume chicken (such as my son, who appeared to exist largely on chicken wings during high school) is in fact - times higher than lasky et al. estimated, resulting in an intake of - µg/day. this is still in excess of the current national research council (nrc) recommendation (nrc ) . this risk estimate does not include the potential for additional exposures to arsenic from confined animal feeding operation (cafo) wastes via land disposal, which may reach human populations though soil contact, groundwater contamination, and plant uptake, as noted in my letter . these exposures may be important for regions such as the eastern shore, where between and million broiler chickens are raised each year. the u.s. geological survey has estimated that thousands of kilograms of arsenic may be land disposed with poultry wastes (garbarino et al. ) . given the article by and new information on the environmental pathways of arsenic releases from cafos (han et al. ; jackson et al. ) , as well as new studies on the health effects of arsenicals (simeonova and luster ) , i suggest that it is time for a thoughtful consideration of the use of arsenicals as growth promoters in animal feeds. the author declares she has no competing financial interests. baltimore, maryland e-mail: esilberg@jhsph.edu "sex and ceruloplasmin modulate the response to copper ..." it is past time for ehp to stop accepting papers whose funding disclosure makes it obvious there is a conflict, yet "the authors declare they have no competing financial interests." stated that "this investigation was funded by the international copper association [ica] in the form of an unrestricted research grant." i fail to see that an unrestricted grant eliminates a conflict of interest. from the article's introduction, it is obvious that this research team has done a lot of copper toxicity work with this money from the ica, but the conflict of interest would exist even if only the work reported in this article was funded by the ica. it is interesting, however, that the ica is funding human experimentation. the pesticide industry's push to allow human experimentation in the toxicity tests to register their pesticides in the united states is driven by their resulting ability to drop the -fold interspecies safety factor in allowable exposure levels. lockwood ( ) found all six human pesticide studies reviewed rife with financial conflict of interests. think of the risks created to all toxicity testing when the most reputable general toxicology journal in the world, ehp, endorses human subjects for toxicity testing in very risky situations. many of us tolerate animal testing because we hope that eventually the current massive risk of toxic agents will be acknowledged. it may seem that this work on cu entailed little risk, as the authors claim in the opening of their discussion: … liver aminotranferases were evaluated to satisfy ethical considerations. we detected no responses that may represent toxic effects of the cu dose used. first, the authors acknowledged that there are large data gaps on the toxicity of cu at many doses. critically, this demonstrable truth makes their statement about detecting no toxic responses false. obviously they were not looking at many toxic end pointsespecially chronic effects. also, they stopped looking for any effects after a very short period ( subjects ingested mg/kg/day cu for months). the stated tolerable daily intake (tdi) in the introduction ) is unclear (and unattributed) , but it appears to range from . to mg/kg/day. the experimental dose chosen for this study was mg/kg/day, and was justified by the authors as being a dose safe for . % of humans. tdis are typically derived from industry junk science (unpublishable in independent journals) and contain massive data gaps. however, even if we assume the claimed tdi is validated, the authors are admiting that their chosen experimental dose was above the "safe" level for about two of their subjects. at the end of the discussion the authors admit that the cu-induced enzyme changes they looked at are altered by hepatic diseases; then state that their results can be used to monitor adverse liver effects. the effect of the combination of risky dosing with acknowledged toxicity data gaps is stunning. in summary, i am disappointed that ehp 's manuscript reviewers and editors allowed such dangerous (unethical) statements and objective inconsistencies; i fear that a human toxicity experiment-in ehp of all places-has created a terrible precedent; and i am frustrated that authors and ehp continue to misstate obvious conflicts of interest. i look forward to discussion and solutions. the author declares he has no competing financial interests. environmental & economic rights) missoula, montana e-mail: ttweed@wildrockies.org correct that although no adverse effect was expected because the dose is safe, ethical considerations made it pertinent to measure their activities. these enzymatic activities are routinely measured for diagnostic purposes in individuals who manifest symptoms of illnesses. it is not known whether they reflect minor changes in hepatic function when enzymatic values are within the normal limits and there is no illness. thus, it was most interesting to assess the potential of these enzymes to detect changes within the normal range in the studied individuals. certainly, our work is based on a series of concepts that include the upper safe limit (which represents the safe chronic average intake of the metal for human beings), tolerable daily intake (tdi), and several others [e.g., dietary allowances, adequate recommended oral intake (aroi), lower concentration of observed effects (loel)] that served to ensure that the protocol was within safe limits for human adults. although approximately - . % of the normal population is not included in some of the concepts mentioned, this does not mean that this percentage will be damaged by the exposure but that they represent individuals with illnesses, and therefore are not included among the normal population, who require a different treatment. all these concepts, of course, are not "typically derived from industry junk science (unpublishable in independent journals)" and they do not "contain massive data gaps," as stated by tweedale, but they do represent the state of the art on a specific topic produced by experts appointed by the national institutes of health, the world health organization, and other respected agencies. our study (mendéz et al. ) indeed followed the ethical considerations required to work with human subjects. the protocol was approved by our institutional review board, which is registered (irb ) with the office for human research protections. last and most important, how to deal with potential conflicts of interest in science is a hot topic, and there is currently no final solution (blumenthal ; morin et al. ; nathan and wilson ; tufts university ) . we made full disclosure of our financial support, and it is up to the readers to judge the situation for themselves. pyrrolizidine alkaloids in food: a toxicological review and risk assessment solidphase extraction and lc-ms analysis of pyrrolizidine alkaloids in honeys availability of draft data summaries and draft priorities for chemicals with respect to their potential to cause cancer: request for relevant information toxicity and carcinogenicity of riddelliine in rats and mice churchill county, nevada homepage leukemia cluster information for cochise county. county of chochise, arizona:cochise county health department fda advises dietary supplement manufacturers references consumer reports mean total arsenic concentrations in chicken - and estimated exposures for consumers of chicken arsenic used in chicken feed may pose threat: hopkins study explores risk to consumers, water arsenic in food environmental fate of roxarsone in poultry litter. i. degradation of roxarsone during composting arsenic solubility and distribution in poultry waste and long-term amended soil trace element speciation in poultry litter mean total arsenic concentrations in chicken - and estimated exposures for consumers of chicken arsenic in food arsenic and atherosclerosis human testing of pesticides: ethical and scientific considerations sex and ceruloplasmin modulate the response to copper exposure in healthy individuals academic-industrial relationships in the life sciences sex and ceruloplasmin modulate the response to copper exposure in healthy individuals managing conflicts of interest in the conduct of clinical trials clinical research and the nih-a report card conflict of interest policy. available: environmental health perspectives • volume understanding the spatial clustering of severe acute respiratory syndrome (sars) in hong kong" stated that "the research was supported by the research fund for the control of government incorrectly listed kathleen vandiver's affiliation as cambridge public schools listed incorrect percentages of intersex frogs collected during the periods studied infectious diseases of the health, welfare and food bureau of the hong kong sar the acknowledgment should have the authors declare they have no competing financial interests. university of chile institute of nutrition and food technology university of chile santiago, chile e-mail: mmendez@inta.cl most unfortunately, tweedale misunderstood and misinterpreted our article "'sex and ceruloplasmin modulate the response to copper exposure in healthy individuals" (mendéz et al. ) . the article is about copper homeostasis and homeostatic regulation, not about toxic effects associated with copper. the dose administered was mg/day and not mg/kg/day, which we agree may be toxic. the dosage and the time of study used allowed us to assess homeostatic mechanisms in normal human beings; this study will contribute to the development of specific recommendations for subgroups of the population that have genetic polymorphisms that render them more susceptible to minor copper deficiency and copper excess.aminotranferases are the current gold standard to assess liver damage; therefore, it is key: cord- -j mme e authors: kandeel, amr; dawson, patrick; labib, manal; said, mayar; el-refai, samir; el-gohari, amani; talaat, maha title: morbidity, mortality, and seasonality of influenza hospitalizations in egypt, november -november date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: j mme e background: influenza typically comprises a substantial portion of acute respiratory infections, a leading cause of mortality worldwide. however, influenza epidemiology data are lacking in egypt. we describe seven years of egypt’s influenza hospitalizations from a multi-site influenza surveillance system. methods: syndromic case definitions identified individuals with severe acute respiratory infection (sari) admitted to eight hospitals in egypt. standardized demographic and clinical data were collected. nasopharyngeal and oropharyngeal swabs were tested for influenza using real-time reverse transcription polymerase chain reaction and typed as influenza a or b, and influenza a specimens subtyped. results: from november –november , , / , ( %) sari cases were influenza-positive. influenza-positive patients were more likely to be older, female, pregnant, and have chronic condition(s) (all p< . ). among them, ( %) died, and death was associated with older age, five or more days from symptom onset to hospitalization, chronic condition(s), and influenza a (all p< . ). an annual seasonal influenza pattern occurred from july–june. each season, the proportion of the season’s influenza-positive cases peaked during november–may ( – %). conclusions: in egypt, influenza causes considerable morbidity and mortality and influenza sari hospitalization patterns mirror those of the northern hemisphere. additional assessment of influenza epidemiology in egypt may better guide disease control activities and vaccine policy. from november -november , , / , ( %) sari cases were influenzapositive. influenza-positive patients were more likely to be older, female, pregnant, and have chronic condition(s) (all p< . ). among them, ( %) died, and death was associated with older age, five or more days from symptom onset to hospitalization, chronic condition(s), and influenza a (all p< . ). an annual seasonal influenza pattern occurred from july-june. each season, the proportion of the season's influenza-positive cases peaked during november-may ( - %) . in egypt, influenza causes considerable morbidity and mortality and influenza sari hospitalization patterns mirror those of the northern hemisphere. additional assessment of influenza epidemiology in egypt may better guide disease control activities and vaccine policy. globally, acute respiratory infections (ari) are the fourth leading cause of death [ ] and second highest cause of years of life lost [ ] , and cause over . million deaths each year [ ] . previous studies have indicated that influenza comprises a substantial portion of ari morbidity and mortality [ ] [ ] , with one estimate that % of global ari deaths were due to influenza infection in [ ] and another that influenza causes , - , deaths each year [ ] . however, little is known about influenza epidemiology in many parts of the developing world, particularly in the eastern mediterranean region (emr). the arab republic of egypt, the second most populous country of the emr, is a medium human-development country [ ] located at the junction of northeastern africa and southwestern asia. egypt has a desert climate with hot, arid summers and moderate winters. the population is over . million, and % are under years old [ ] . in egypt, studies have evaluated limited aspects of human infection with avian influenza and the advent of the influenza pandemic [ ] [ ] [ ] [ ] [ ] ; however, nationwide data on influenza morbidity, mortality, and seasonality are limited. resolving knowledge gaps in influenza epidemiology in egypt serves several purposes. first, a seasonal influenza vaccine is available each year that can prevent infections. recent u.s. estimates of the effectiveness of northern hemisphere influenza vaccines ranged from - % [ ] . even a moderately effective vaccine could reduce influenza-associated hospitalizations and lost worker productivity. understanding whether influenza strains match those in either northern or southern hemisphere circulation will elucidate whether northern or southern hemisphere seasonal influenza vaccine is a viable policy. additionally, data on whether demographic subpopulations are disproportionately affected by influenza may lead to designation of priority groups if vaccine availability is low. second, improved understanding of the timing of influenza circulation may result in a more cost-efficient timing of resource allocation (e.g., antivirals) for hospitals and other clinical settings. this could reduce financial burdens on hospitals during times of elevated influenza transmission. finally, enhanced data on annual influenza activity may provide a baseline metric to evaluate future activity. therefore, influenza epidemics may be detected earlier allowing public health officials to respond faster and have more opportunity to interrupt transmission. in , the eastern mediterranean acute respiratory infection surveillance (emaris) network was established to initiate sentinel surveillance for severe acute respiratory infections (sari) to provide a better understanding of the epidemiology and viral etiologies of sari in the emr. the emaris network was formed through a collaboration of participating countries' ministries of health, u.s. centers for disease control and prevention (cdc), u.s. naval medical research unit no. (namru- ), and world health organization (who) eastern mediterranean regional office. we describe seven years of influenza epidemiology from the emaris-egypt multi-site sentinel sari surveillance system. the aims of this study were to ( ) assess the proportion of sari cases having influenza infection in egypt; ( ) examine the types and subtypes of detected influenza viruses in egypt; ( ) compare demographic and clinical characteristics of influenza-positive sari cases to those of influenza-negative sari cases in egypt; ( ) quantify influenza deaths and assess influenza mortality risk factors in egypt; and ( ) establish a defined period of influenza seasonality in egypt. a hospital surveillance team conducted sari surveillance at each site. these teams included a surveillance coordinator, internist, pediatrician, and laboratory focal person, each of whom was trained on case definitions, enrollment procedures, specimen collection, and data recording. teams screened all hospitalized patients with the sari case definition. all hospitalized patients (including weekend admissions) who met the case definition and were admitted between november , and november , were eligible for enrollment, and those who provided informed consent were enrolled and assigned a unique study identification (id) number. the case definition for identifying eligible patients was standardized across the emaris network. emaris participants reviewed the case definition each year, and it changed several times due to partner input and updated who guidance on sari: from - , the who sari case definition was used [ ] ; from - , the case definition became any hospitalized patient days or older meeting the who definition, or any patient meeting the cdc international emerging infection program pneumonia case definition [ ] , or any patient suspected to have sari; from - , the revised who sari case definition was used (any hospitalized patient with a history of fever ( °c) and cough in the past seven days) [ ] , although clinicians could still enroll patients suspected to have sari; and finally, in , the symptom history was extended to the past ten days to align with the revised who sari case definition [ ] . each enrolled patient had an oropharyngeal and nasopharyngeal swab taken with a sterile tip flocked with nylon fiber swab applicator within hours of hospital admission. all collected swabs from a patient were placed in a ml tube with ml viral transport medium and agitated vigorously for seconds in a vortex mixer. the resulting supernatant was split into two cryovials pre-labeled with the patient's study id number and stored in - °c freezers before testing. real-time reverse transcription polymerase chain reaction (rtrt-pcr) was conducted to detect influenza virus, types, and influenza a subtypes (determination of influenza b lineage was not done) [ ] . specimens were first tested at the hospital or central public health laboratory (cphl) of the egypt ministry of health (moh), a recognized who national influenza center, and then at namru- , a who regional reference laboratory, for quality assurance. namru- results were recorded as the gold standard final result by study id into microsoft excel (redmond, wa, usa). laboratory results were recorded as influenza negative, a/h n , a/h n pdm , a/h n , a/h n , a/unsubtyped, or b. for analytical purposes, specimens positive for two or more influenza types were coded according to the first specimen listed of: a/h n , a/h n pdm , a/h n , a/h n , b, a/unsubtyped. hospital surveillance teams completed a case report form including the unique study id and demographic and clinical data for each enrolled patient. no other identifying information was recorded. the form was standardized across the emaris network. teams followed each patient prospectively until discharge, transfer to another hospital, or death, and collected data including age, sex, reported history of fever and cough, date of symptom onset, date of hospitalization, and date of last follow-up (i.e., the date of discharge, transfer to another hospital, or death). sari cases and associated laboratory results were dated as the patient's hospital admission date. teams also abstracted data from medical records, such as chronic medical conditions and pregnancy status. each form was entered into microsoft access at moh and sent to a central database at namru- . data managers performed double data entry and resolved any identified discrepancies amongst each other. the surveillance case report form database was merged with the laboratory result database, and the resulting database was cleaned and imported into sas . (sas institute, cary, nc, usa) for analysis. bivariate analyses of demographic and clinical data were conducted with the influenza laboratory result (positive versus negative) to generate counts and percentages and compare categorical levels by pearson's chi squared test. the odds of death among influenza-positive cases were modeled with logistic regression using different explanatory variables (age group: pediatric < years old versus adult years old; sex: male versus female; days from symptom onset to hospitalization: - versus - versus ; chronic conditions: at least one versus none; and influenza type: a versus b). statistical significance was set at an alpha level of . . continuous variables were assessed individually to generate the median, range, and interquartile range (iqr). monthly influenza positivity rate was calculated as the proportion of specimens positive for influenza out of the total specimens tested for influenza each month. influenza seasonality was evaluated by examining the monthly average number and proportion of influenza-positive specimens. the influenza season was defined as beginning on the month having the lowest average influenza activity over the entire period and ending one year later. the month having the highest proportion of a season's influenza-positive specimens was considered that season's peak while the month having the lowest proportion was considered that season's nadir. namru- institutional review board (irb), cdc institutional review board, and egypt moh institutional review board approved the sari surveillance protocol in and maintained approval for the duration of the surveillance period. written informed consent was not required by the irbs due to the minimal risk faced by patients and because sentinel sari surveillance is part of egypt's national routine respiratory infection surveillance system of the egypt moh (the requirement was waived), but verbal informed consent was required. hospital surveillance teams provided consent information to patients both written and verbally in arabic, allowing adequate time for consideration. verbal informed consent was also obtained from the parents, caretakers, or guardians on behalf of all children/minors enrolled in the study. verbal informed consent was documented by the enrolling physician signing the consent form if the patient approved. the informed consent process for this study was approved by the three aforementioned institutional ethical review boards. from november -november , , patients met the sari case definition and had a specimen tested for influenza by rtrt-pcr (s file). of these, , ( %) were influenzapositive. a total of , ( %) were influenza a-positive and ( %) were influenza b-positive. of the , influenza a-positive specimens, ( %) were subtyped as seasonal a/ h n , , ( %) as a/h n pdm , ( %) as a/h n , ( %) as a/h n , and (< %) as a/unsubtyped. demographic and clinical characteristics of sari patients by viral influenza result are shown in table . influenza-positive patients differed from influenza-negative patients by age group (p< . ). among those with available data on age, % of influenza-negative patients were under five years old compared to % of influenza-positive patients. the median age of influenza-positive patients was higher than that of influenza-negative patients: years (range month- years, iqr - years) compared to years (range month- years, iqr - years). including missing data, influenza-positive cases were more likely to be female (and if female, be pregnant), have a preexisting chronic condition, require ventilation, be admitted to an intensive care unit (icu), and die (all p< . ). when missing data were excluded, statistically significant (p< . ) differences persisted except for ventilation, icu admission, and death. the median duration from symptom onset to hospitalization among all patients was days (iqr - among influenza-positive and - among influenza-negative), and this did not change by sex, age group, or both sex and age group. the median duration from hospitalization to end of follow-up among all patients was days (iqr - among influenza-positive and - among influenza-negative), and this did not change by sex, age group, or both sex and age group. of the , influenza-positive cases, ( %) died. influenza-positive deaths comprised % of sari deaths. among the influenza deaths, % were - years old, % were male, and % had a preexisting chronic condition. twelve percent ( / ) of females who had influenza and died were pregnant. influenza a accounted for % of influenza-positive deaths, and of the influenza a deaths, % were subtyped as a/h n pdm , % as a/h n , % as a/ h n , and % as a/unsubtyped. the sari case fatality rates by influenza virus type were: % ( / ) a/h n , % ( / ) a/unsubtyped, % ( / , ) a/h n pdm , % ( / ) b, % ( / ) a/h n , and % ( / ) seasonal a/h n . the median duration from symptom onset to hospitalization and the median duration from hospitalization to end of follow-up were both days among influenza-positive cases who died. factors associated with death among influenza-positive cases are displayed in table . adjusting for all covariates, the odds of death among influenza-positive cases were significantly greater for adult versus pediatric patients, patients having symptoms for five or more days before hospitalization versus two or less days, patients with a preexisting chronic condition, and patients having influenza a versus b (all p< . ). the calendar month with the lowest average number and proportion of influenza-positive cases was july, making july the influenza activity nadir. the influenza season in egypt was therefore defined as beginning in july and concluding in june. the calendar month having the highest average number and proportion of influenza-positive cases was december, making december the influenza activity peak. seasonal influenza activity peaks (fig ) discussion this is the first study to examine national influenza epidemiology and seasonality in egypt. data from egypt's sari surveillance system were used to describe influenza hospitalizations at eight geographically-representative egyptian hospitals across a seven-year period. we found that approximately one of every six sari patients had an influenza infection, and during months of peak influenza activity, this was as high as one of every two. influenza-positive patients were different from influenza-negative patients in a number of ways, though differences regarding ventilation, icu admission, and death were inconclusive. death among influenza-positive patients was associated with four characteristics. we also found marked influenza seasonality beginning in july each year and ending in june. seasonal peaks occurred from november to may, and the peak month contained an average of % of the entire season's influenza infections. our findings indicate that influenza leads to substantial morbidity and mortality in egypt among people of all ages and both sexes. from - , nearly , influenza hospitalizations were detected by the eight sentinel hospitals, approximately % of sari hospitalizations. this figure is nearly double those recently found in other emaris network countries: % in oman and % in jordan [ ] [ ] , and larger than estimates obtained in multiple african [ , ] and asian countries [ ] [ ] . furthermore, influenza accounted for % of sari deaths in egypt. this mirrors the recent worldwide estimate of % [ ] . comparison of demographic characteristics revealed that some individuals have increased odds of severe influenza infection in egypt. among the age groups encompassing - years, patients were more likely to have influenza. more influenza-negative patients were under five years old, possibly due to pediatric respiratory syncytial virus (rsv) infection which has been shown to be more prevalent among infants and young children in egypt [ , [ ] [ ] . a similar proportion of influenza-positive and influenza-negative patients were years or older, possibly reflecting that elderly adults are simply predisposed to aris of various etiologies. other factors associated with influenza among those hospitalized with sari from this study include pregnancy and chronic conditions. influenza-positive women were more likely to be pregnant, and numerous other studies have identified pregnancy as a risk factor for influenza and influenza complications [ ] [ ] [ ] [ ] [ ] . chronic conditions were also associated with influenza hospitalization, as % of influenza-positive patients had at least one. previous studies have shown that chronic disease is a risk factor for influenza and complications due to influenza [ ] [ ] [ ] [ ] . although % of patients with influenza died, there was no apparent difference in mortality between influenza-positive and negative patients. regardless, patients with influenza infection comprised % of total sari deaths. analysis of influenza mortality among hospitalized patients with influenza found four potential risk factors: older age, chronic conditions, a longer duration from symptom onset to hospitalization, and influenza a virus infection. overall, the number of deaths was greater for those with influenza a than influenza b, which aligns with previous research [ ] [ ] . the influenza subtype with the highest mortality ( %) was a/ h n avian influenza. as of march , , the worldwide a/h n case fatality rate was % [ ] , similar to our finding. furthermore, though % of patients with influenza a/unsubtyped died, there were only eight such infections. additionally, a longer duration from symptom onset to hospitalization increased the odds of death among influenza-positive patients. this supports previous research that found a longer duration from influenza symptom onset to hospitalization increased the odds of death [ ] [ ] , which may be due to individuals' healthcareseeking behavior, i.e., avoiding a hospital visit until it is too late for medical intervention. in addition to influenza hospitalization morbidity and mortality in egypt, we were able to assess seasonality over seven years. we observed an annual seasonal pattern beginning in july and ending the following june. overall influenza activity peaked in november-may, with the peak month having - % of that entire season's influenza infections and accounting for - % of all sari cases that month. these seasonal peaks were largely driven by influenza a, and in some seasons, there were bimodal influenza peaks corresponding to an earlier influenza a peak followed by a later influenza b peak. climate has been shown to correlate with influenza activity worldwide, particularly lower temperatures and lower relative humidity [ ] [ ] [ ] . although egypt has a desert climate with year-round high temperatures [ ], we observed annual northern hemisphere influenza seasonality with activity peaks in the winter and spring, perhaps due to lower temperatures during those months. based on these data, seasonal influenza vaccination in egypt may be a useful recommendation. the system identified predominant influenza strains each season [ ] , indicating some seasonal influenza transmission could have been interrupted by vaccination. however, future studies are needed to antigenically characterize the predominant influenza strains in egypt to assess their similarity to strains included in the corresponding season's vaccine. possible priority groups for vaccination in egypt include pregnant women, individuals with chronic conditions, and older adults based on aforementioned findings. influenza seasonality in egypt suggests an ideal timing for resource allocation and provides a baseline metric on which to compare future activity. these data indicate that egyptian hospitals should prepare for peak influenza activity from november-may. stockpiling antiviral medication, increasing staff capacity, and reserving hospital beds could begin in october and be scaled back in may. also, moh and partners could use these data to determine average weekly influenza hospitalization activity (smoothed with moving averages) for evaluation of future activity. this will allow for earlier discovery of unusual influenza activity, including crossing of epidemic thresholds, allowing for a faster public health intervention. there were limitations to these data. first, the system's detection of influenza relied on the case definition's sensitivity and specificity, and the definition changed over time based on who guidance. it is possible the system missed some hospitalized individuals with influenza. however, the case definition was standardized across the network and the system detected a higher proportion of influenza sari hospitalizations than other countries. second, more comprehensive demographic and clinical data were unavailable, and thus more nuanced analyses of risk factors were not possible. this is a reality of surveillance as only basic data are collected to reduce staff burden. third, data were missing for a sizeable number of individuals for some variables. therefore, statistical comparisons were presented both including and excluding missing data, and some comparisons yielded divergent results (implying statistical significance was driven by the extent of missing data for some variables). work to maintain the quality and integrity of surveillance data through the emaris network is ongoing, including improving motivation among hospital surveillance teams. strengths of this study stem from its scale, length of observation, and capabilities to detect influenza virus. the use of eight sentinel hospitals representatively distributed throughout egypt allowed for adequate generalizability of findings to the national level. furthermore, with over , patients enrolled, there was ample power to detect meaningful differences in demographic, clinical, and virological characteristics. the seven-year period of surveillance afforded the opportunity to examine influenza seasonality over time, which is only possible with several years of data. finally, egypt's cphl and namru- enabled sensitive and specific detection of influenza viruses and types via rtrt-pcr for all , sari patients. this is the first documented examination of national influenza epidemiology in egypt. given the dearth of influenza knowledge in the emr, our study helps fill a critical epidemiologic gap for the second most populous country in the region. our findings indicate that influenza is an important cause of morbidity and mortality. furthermore, it appears to have northern hemisphere seasonality, though not as pronounced as in temperate climate countries. therefore, seasonal influenza vaccination may be a viable policy. ultimately, the emaris network provided numerous benefits, namely increased epidemiologic and laboratory capacity, enhanced international health regulations ( ) compliance, and a sustainable sari surveillance system. such a system is a crucial component of modern disease control, as evidenced by the recent appearance of middle east respiratory syndrome coronavirus [ ] . it may also be adapted for other novel aris, which is imperative given growing concern over the emergence of new influenza viruses with pandemic potential [ ] [ ] . continued surveillance for influenza and further assessment of its molecular epidemiology will better inform decision-makers about disease control activities in egypt and the greater emr. supporting information s file. raw data. data file (sas format) for the severe acute respiratory infection (sari) sentinel surveillance system in egypt. (sas bdat) the findings and conclusions in this reports are those of the authors and do not necessarily reflect the official policy or position of the department of the navy, department of defense, the centers for disease control and prevention, u.s. government, nor egypt ministry of health. patrick dawson and maha talaat are contractors of the u.s. government. mayar said is an employee of the u.s. government. this work was prepared as part of their official duties. title uscx provides that "copyright protection under this title is not available for any work of the united states government." title usc x defines u.s. government work as work prepared by a military service member or employee of the u.s. government as part of that person's official duties. the study protocol was approved by the naval medical research center institutional review board in compliance with all applicable federal regulations governing the protection of human subjects. conceptualization: ak mt. data curation: pd. world health organization. global health observatory data repository: causes of death acute respiratory infections: making inroads against a forgotten pandemic global burden of respiratory infections due to seasonal influenza in young children: a systematic review and meta-analysis influenza surveillance in countries in africa global and regional mortality from causes of death for age groups in and : a systematic analysis for the global burden of disease study united nations development programme age-based human influenza a virus (h n ) infection patterns burden of pediatric influenza a virus infection post swine-flu h n pandemic in egypt severe atypical pneumonia outbreak associated with influenza a(h n ) pdm in egypt, - season risk factors of prolonged hospital stay in children with viral severe acute respiratory infections avian influenza a(h n ) and a (h n ) seroprevalence and risk factors for infection among egyptians: a prospective, controlled seroepidemiological study centers for disease control and prevention. seasonal influenza vaccine effectiveness world health organization. paho-cdc generic protocol for influenza surveillance centers for disease control and prevention international emerging infections program (ieip): thailand. description of clinical pneumonia world health organization. who global technical consultation: global standards and tools for influenza surveillance world health organization. global epidemiologic surveillance standards for influenza rapid and sensitive method using multiplex real-time pcr for diagnosis of infections by influenza a and influenza b viruses, respiratory syncytial virus, and parainfluenza viruses , , , and the burden of influenza-associated hospitalizations in oman influenza hospitalization epidemiology from a severe acute respiratory infection surveillance system in jordan sentinel surveillance for influenza-like illness, severe acute respiratory illness, and laboratory-confirmed influenza in kinshasa, democratic republic of congo incidence of influenza-like illness and severe acute respiratory infection during three influenza seasons in bangladesh estimating influenza outpatients' and inpatients' incidences from to in a tropical urban setting in the philippines viral etiologies of lower respiratory tract infections among egyptian children under five years of age incidence and clinical features of respiratory syncytial virus infections in a population-based surveillance site in the nile delta region risk of acute respiratory disease among pregnant women during influenza a epidemics fatal swine influenza pneumonia during late pregnancy hospitalizations with respiratory illness among pregnant women during influenza season severity of pandemic influenza a (h n ) virus infection in pregnant women pregnant women infected with pandemic influenza a(h n )pdm virus showed differential immune response correlated with disease severity impact of epidemic type a influenza in a defined adult population survey of underlying conditions of persons hospitalized with acute respiratory disease during influenza epidemics in houston impact of respiratory virus infections on persons with chronic underlying conditions the burden of influenza illness in children with asthma and other chronic medical conditions the impact of influenza epidemics on mortality: introducing a severity index mortality associated with influenza and respiratory syncytial virus in the united states world health ogranization. cumulative number of confirmed human cases for avian influenza a(h n ) reported to who infection and death from influenza a h n virus in mexico: a retrospective analysis outcomes of adults hospitalised with severe influenza association of influenza epidemics with global climate variability influenza virus transmission is dependent on relative humidity and temperature seasonality, timing, and climate drivers of influenza activity worldwide available candidate vaccine viruses and potency testing reagents world health organization. interim surveillance recommendations for human infection with middle east respiratory syndrome coronavirus pandemic threat posed by avian influenza a viruses epidemiology, ecology and gene pool of influenza a virus in egypt: will egypt be the epicentre of the next influenza pandemic? the authors wish to thank all egypt ministry of health and central public health laboratory staff and hospital surveillance coordinators for their participation and continued excellence in sari surveillance. key: cord- - ni vv l authors: zhang, han; nurius, paula; sefidgar, yasaman; morris, margaret; balasubramanian, sreenithi; brown, jennifer; dey, anind k.; kuehn, kevin; riskin, eve; xu, xuhai; mankoff, jen title: how does covid- impact students with disabilities/health concerns? date: - - journal: nan doi: nan sha: doc_id: cord_uid: ni vv l the impact of covid- on students has been enormous, with an increase in worries about fiscal and physical health, a rapid shift to online learning, and increased isolation. in addition to these changes, students with disabilities/health concerns may face accessibility problems with online learning or communication tools, and their stress may be compounded by additional risks such as financial stress or pre-existing conditions. to our knowledge, no one has looked specifically at the impact of covid- on students with disabilities/health concerns. in this paper, we present data from a survey of students with and without disabilities collected in late march to early april of to assess the impact of covid- on these students' education and mental health. our findings show that students with disabilities/health concerns were more concerned about classes going online than their peers without disabilities. in addition, students with disabilities/health concerns also reported that they have experienced more covid- related adversities compared to their peers without disabilities/health concerns. we argue that students with disabilities/health concerns in higher education need confidence in the accessibility of the online learning tools that are becoming increasingly prevalent in higher education not only because of covid- but also more generally. in addition, educational technologies will be more accessible if they consider the learning context, and are designed to provide a supportive, calm, and connecting learning environment. the impact of covid- on students in general can potentially be large. worries about fiscal and physical health, rapid change, and increased isolation are all factors that can affect students and general. students with disabilities/health concerns may face greater risks than their non-disabled peers in a wide range of aspects. first, they have higher financial risk due to the need for accessible housing and personal assistance. moreover, they face greater health risks, depending on their specific situation. in addition, the risk to their education is also higher due to potentially inaccessible course content and classroom environments [ , ] . these risks may increase further in the face of a global health pandemic. an understanding of the impact of covid- on students with disabilities/health concerns is important so that we can identify these increased risks early and respond to them. in this paper, we define disability broadly to include anyone who self-identifies as disabled and also those with health concerns who may not identify as disabled [ ] . we focus on two specific issues of concern to all students: education and mental health. both are currently under stress, and understanding how and whether those stresses differentially impact students with disabilities/health concerns is critically important. by comparing data about students' experiences during covid- we hope to identify areas of concern. to this end, we present descriptive data showing how students with disabilities/health concerns, in comparison to their non-disabled peers, are faring in the covid- context. we present an analysis of data from a multi-year study at a large public university that has included approximately students per year, including students with and without disabilities/health concerns [ ] . in this paper, we focus specifically on the impact from survey results from spring (during the covid- pandemic), in which we ask students about their physical and mental health, their academic and social experiences, and specific concerns about covid- . our sample includes students with disabilities/health concerns in . where relevant, we also make comparisons to data collected from a subset of students, of whom have disabilities/health concerns who filled out a very similar survey in spring (before covid- ) . we contribute insights about university students' early responses just before and during covid- , to characterize patterns of concern, challenging experiences, and stress as well as initial indicators of mental health. our central focus is on students with disabilities/health concerns, and the impact of covid- on their education and health. educational impacts. the shift to online learning may impact the types of access technologies and techniques that students use, as well as their dependence on online course materials that may not be accessible [ , ] . particularly, as many universities made a late decision to teach online, instructors had less time than usual to prepare materials for an online setting, which may have impacted the accessibility of those materials. at the same time, for some students the ability to participate online may increase accessibility. we contribute an analysis of educational concerns and how they differ from before to during covid- . we compare students with and without disabilities/health concerns, and we analyze differences between different classes of disabilities/health concerns. our findings suggest that students with disabilities/health concerns have increased concerns about classes going online over those without, particularly the impact on their degree goals such as admission to major and graduation timing. impact on mental health. when social systems are placed under stress due to sudden forces such as a global health pandemic, the impact on marginalized populations can be especially severe. outbreaks of widespread infectious diseases, such as sars and covid- , are associated with psychological distress and eroded mental health, stimulating calls for mental health care to be part of the national public health emergency system [ ] . our examination of mental health impacts starts with exposure to stressors. we look at several potential sources of stress, including the use of social media, income loss, quarantine and isolation, loneliness, chronic discrimination, and overall exposure to adversity. at the time our data was collected, just after classes went online and three weeks after it was discovered that community spread of covid- was present in seattle (table ) , we did not find evidence of changes in anxiety, stress, or depression among students with or without disabilities/health concerns. however, students with disabilities/health concerns reported more stress exposure, and more distress, than those without. implications for accessible online education. although our sample is small and the timing early in the covid- crisis, this data provides an important snapshot into the consequential nature of students' concerns about online education, which includes the impact not only on grade, but also on admission to major and graduation. the covid- epidemic's impact on learning should be a wake-up call to accessibility researchers to study online learning technologies and their impacts, and higher education in general, from a disability perspective. although social distancing may fade into memory, it is likely that online learning will not. even before covid- , online education was beginning to achieve parity with in-person education [ ] . yet this is a topic that has received little attention from computer scientists or accessibility researchers. a title word search for "education or course or teaching" within the assets proceedings found only matches, of which most discuss introducing curricula that would educate technologists about accessibility (e.g., [ ] ). while some deal with online educational tools in general (e.g., [ ] [ ] ), or childrens' access to the mainstream education system [ ] , there is much less work published about higher education. although this is a limited search, it highlights the relative lack of attention to online learning, and higher education in general, in the accessibility community (in contrast, the keyword "blind" found matches). our work provides motivation for the importance of improving the accessibility of online classes (and relatedly the ease with which instructors can make such classes accessible). in addition, as ringland et al. argue [ ] , accessibility solutions must take a holistic, contextualized view of the person, including consideration of their potential stresses and concerns. thus, we argue that under covid- (and, really, in general) an accessible education is also one that contributes to student well-being and resilience. our data help to justify this need by demonstrating that, at least in our sample, students with disabilities are operating under increased stress loads both over their lifetime and specifically since the beginning of the covid- pandemic. life as an undergraduate student presents an exciting and challenging opportunity to learn, innovate, and grow. however, exposure to stress is also common among college students [ ] . in addition, some stressors differentially impact vulnerable groups, and these impacts can translate into changes in mental health and behavior (e.g., [ ] ), particularly when they interact with risk [ ] . increasing participation by people with disabilities requires understanding and efforts to lessen the particular stresses and risks they face. the covid- pandemic is one obvious stressor that may directly impact students in a multitude of ways. some may be at greater risk of contracting the illness and interrupted access to health services [ ] . pandemics can also impact availability of personal assistance, reduce educational accessibility [ ] , and create higher risks of exposure than for the overall population [ ] . below we explore expected consequences for learning and mental health of these stressors for people with disabilities. one significant impact of covid- has been the shift to online learning. online learning has become increasingly common over the last decade [ ] , and even before the radical changes imposed by social distancing in the era of covid- , issues existed with the accessibility of online courses. for example, at one university, % of faculty reported having never made accommodations in their online material [ ] , most having never been asked by students to do so. student reluctance to ask for accommodation is driven in part by concerns about faculty bias [ ] . due in part to the lack of perceived need among professors, the perspective of students with disabilities indicates that online learning is not fully accessible [ ] . in addition, the move to increased asynchronous learning can leave students with disabilities behind, as, for example, videos are often not captioned. as of , only blackboard (of all online learning management systems) had been awarded gold certification for its accessibility by the national federation for the blind [ ] . in addition, content generators (i.e. faculty) have a big impact on the accessibility of their content [ , ] and over half ( %) of faculty are unsure or do not know how to make accommodations [ ] . this results in many courses being designed and deployed without accessibility support [ ] . when faculty additionally have to make very rapid changes to their courses due to pressure to go online quickly, it is even less likely that they will make time to attend to an issue they are unsure of, like accessibility. at the same time, a shift to online learning due to a pandemic could benefit students with disabilities. for example, going online might reduce the need for disclosure, increase flexibility if instructors are being especially accommodating under the circumstances, or reduce barriers for students with mobility-related impairments. even before the pandemic, universities were seeing high and growing levels of mental health struggles among students [ ] . further, natural disasters as well as past epidemics such as sars, have been associated with psychological distress, depression and substance abuse [ , , , , ] . adverse psychological effects of the current pandemic may also be serious, but are not expected to be uniform [ ] . for example, many individuals show resilience in disasters; this resilience manifested in a recent study of college students who, contrary to expectations, reported less loneliness in april than in february of this year [ ] . daily surveys by kanter et al. of the general population from march th through may th (during the covid- epidemic) have not shown overall increases in anxiety, depression or loneliness (https://uwcovid .shinyapps.io/dashboard/). on the other hand, students with a history of stress exposure may have raised allostatic load [ ] , lowering the physiological resilience to the additional demands brought on by the pandemic. it is unclear whether students with disabilities/health concerns are likely to experience mental health consequences of covid- 's impact on society. what is expected is that people with disabilities/health concerns are likely to experience more stressors associated with the pandemic. in addition to the risks of covid- , and educational accessibility, emergency response plans do not always include planning for people with disabilities [ ] , social distancing may be harder for people with disabilities who rely on caregivers, and people with disabilities may have to deal with inaccessible communications [ ] . these risks may put people with disabilities at greater risk of experiencing distress associated with the pandemic. their concerns about personal safety may be stronger than those of people without disabilities and they may be more vulnerable to stressors during the pandemic (such as disruption of critical health care). for these reasons they may be at greater risk of psychological distress. given the literature thus far, there is cause for concern. the covid- context appears to be exacerbating risks related to mental health, educational outcomes, and physical health, particularly for students with disabilities. thus, this paper addresses time-sensitive questions regarding the adversity profiles and well-being of university students during the current pandemic, with particular focus on ways that students with disability needs may differ from nondisabled students. drawing from research related to cumulative disadvantage and marginality [ ] , we anticipate that students with disabilities will express justifiably greater vulnerability in the covid- context through elevated levels of concern about their educational environment and likelihood of success, as well as features of their family and personal lives affected by the pandemic. finally, we anticipate that students with disabilities may be experiencing greater levels of psychological distress in the form of mental health indicators. our data are derived from a multi-year study, the university of washington experience (uwexp) [ ] , which is in its third year of collecting data about college students' behaviors, mental health, education and well-being. this, in turn, was inspired by a study first pioneered by wang et al. [ ] . the goals of the uwexp study are to understand the stressors impacting undergraduate college students through a combination of self-reported information about demographics, health and well-being, institutional data about educational outcomes, and behavioral data collected using fitbits and mobile phones. in , we recruited from all past participants in the uwexp study and additionally advertised to the entire university of washington entering first-year student class. in addition, we conducted targeted recruitment in communities that might be marginalized including students with disabilities, and first-generation college students. students are paid to participate in the study, which is irb approved. in this paper, we primarily make use of the uwexp survey data collected in spring of , within the covid- context. students were instructed to complete the survey after their last winter quarter final. at that time, the university of washington had been teaching online for at least two weeks, and students knew that half or more of spring quarter would be online. the uwexp baseline survey data was conducted from march th through april th (end of winter quarter through beginning of spring quarter). the majority ( %) of students completed it between march th and march th. at the time, social distancing restrictions were increasing city and state-wide, with the initial stay-at-home order for washington issued march rd. the full timeline is shown in table . students answered an hour-long questionnaire consisting of demographics and a series of well-established scales to measure depression (ces-d [ ] ); perceived stress (pss [ ] ); anxiety (stai [ ] ); loneliness (ucla [ ] ); chronic discrimination and harassment (cedh [ ] ); perceived social status (ses, measured using the macarthur scale of subjective social status [ ] ) and major life events (mle [ ] ). several of these scales ask students to reflect over a period of time: the depression scale items measure the past week; whereas perceived stress and trauma symptomology assessed the past month. students reported major life events (adverse, traumatic or stressful events) over their lifetime. they reported their depression-related feelings that occurred during last week. we measured trait anxiety and loneliness does not provide a timescale, it is thus likely that answers to the loneliness scale reflect current (in-the-moment) status. in addition, since one arm of the uwexp study was concerned with adversity exposure and related symptoms, the data collection protocol includes a scale designed to measure post-traumatic stress disorder (ptsd) symptomology [ ] . we note that in a population without known exposure to severe trauma (such as most of our participants), the items in this scale are better conceptualized as a measure of distress rather than indicative of clinical post-traumatic stress. date event / evidence of community spread discovered in seattle / first covid- related death discovered in seattle / announcement that classes would officially switch to online / last day of instruction for winter quarter and announcement that spring quarter will begin online / announcement that spring quarter will be fully online / earliest date a student took the baseline survey / last day of final exams for winter quarter / instruction for spring quarter begins / latest date a student took the baseline survey when no established measures were available, we created questions to address variables of interest such as adverse events due to covid- . this included questions about students' levels of concern about current life issues-both educational and family related; questions about covid- specific adversity exposures; and a single item asking if they have a pre-existing condition that makes them vulnerable to covid- . in addition, the uwexp study includes a student-specific measure of covid- related adversities. students participated in the survey, of whom stayed in the study ( . % retention rate). we removed the data for the five students who dropped out from our data analysis. we assign disability status primarily based on self-identification. additionally, we added people who gave very high responses (moderate or severe) on at least eight of the items of the cohen-hoberman inventory of physical symptoms (chips) scale [ ] , which included energy impairment suggestive of a chronic health condition. our choice to include disabling health conditions is consistent with classification systems and service provision contexts [ , ] . this also helps address under-identification of disabling statuses; for example, about % of people with energy-impairing chronic conditions do not identify as disabled [ ] , but often still encounter similar barriers as people who do identify as disabled. analysis was guided by the research questions, largely focused on full sample portrayals of variable distributions as well as between-group tests of difference. we run both t-tests (parametric) and mann-whitney u tests (non-parametric) for significance testing; we had the same significance levels for all the pairwise comparisons, thus, we chose to report the results of t-tests for consistency. most results meet < . or better, and the number of repeat comparisons is small, so we did not correct for multiple comparison. the study included students ( only a few reported a pre-existing condition that made them vulnerable to covid- ( ( . %)) and the average ses score is . . there are students with disabilities/health concerns. note that students could indicate multiple types of disability and that one student with a high chips score also identified as disabled, which is why there are disabled students and students with high chips scores. students with disabilities/health concerns had higher marginalized status or vulnerabilities than students without in the study: . % ( ) are female, and . % ( ) male, . % ( ) are asian, . % ( ) are first-generation college students, . % ( ) are lgbtqia+ and the average ses is . . although the majority of our analysis only looks at the survey participants, we also look at times at data collected in . of the students, students returned from including with disabilities/health concerns. these students filled out the same survey in and , at the same time of year, with the exception of covid- specific questions, which were added in . firstgen stands for first generation students (whose parents did not complete college). covid health vulnerability are students who self-identified as having a pre-existing condition that puts them at risk for coivd- . students self-identified their disability. in this section, we first present students' levels of concern regarding the potential negative effects of the covid- context on their educational standing and success. we then summarize and contrast students' adversity exposures, both those directly covid-related as well as from sources such as discrimination, loneliness, and stress profiles via histories of major life adverse events. finally, we compare students with disabilities/health concerns to those without disabilities/health concerns regarding their current mental health statuses. as noted in table , the university of washington courses went online approximately two weeks before the end of winter quarter (early march), and students filled out the survey after taking their last final. part of that assessment was students' concerns about the potential impact of covid- on their academic well-being. figure shows the percentages of students with and without disabilities/health concerns across eight indicators. at the time, things were in flux, but students knew that spring quarter would be at least partly online. as is evident, concerns ranged high on many of these factors. more than % of students with disabilities/health concerns were very concerned about grades in both winter and spring quarters, as well as whether they would have to move degree requirements, negative impact on courses that could not then go online, admission to preferred major being threatened, and, to a lesser degree, negative impact on graduation and financial aid. students with disabilities/health concerns were substantially more concerned ( = . , = . ) than their non-disabled peers ( = . , = . ), with means calculated as a sum across all items. this difference is significant ( ( ) = . , < . ). given the wide range of disability identities represented in our sample, it is possible that not all students with disabilities/health concerns share the same levels of concern. for example, students with high fatigue may well context. the x axis shows the type of concern. the y axis shows percentage of students, within group. for example, students with disabilities/health concerns were concerned about moving degree requirements (almost % of all students with disabilities) and students without disabilities/health concerns (around %). prefer to stay home, whereas a student with hearing impairment may need to rapidly change how they access audio material through a transcription or sign language translation service. we anticipated that students with vision or hearing impairments might face greater barriers going online than those with mental health conditions or other disabilities/health concerns. however, of the students who answered this question, we found that there was no toward assessing student vulnerabilities within the early covid- context, we turn next to identifying areas of adversity exposure relevant to psychosocial functioning as well as mental health statuses as reflected through clinical measures. we begin by investigating covid- related stressors that students were experiencing outside of their educational settings and differences for those with disabilities/health concerns. as can be seen in figure , students with disabilities/health concerns experienced more stress than those without due to a range of financial, family and isolation issues. experiencing tensions within the household during this period of isolation reflected the greatest disparity between students with disabilities/health concerns and their non-disabled peers. we also asked about whether social media use was a source of stress. this was high for all participants (over half agreed or strongly agreed); however the difference between students with and without disabilities/health concerns was not significant. table reports group comparisons on four forms of adversity that could have implications for stress and functioning. in this data, the cedh instrument measures chronic discrimination and harassment over the past twelve months, major life events is capturing stressors over the lifetime, and covid related adversities provides a sum of the % % % % % personal income loss ( , ) family income loss ( , ) self quarantine ( , ) family in quarantine ( , ) isolated ( , ) tension ( , ) students with d/h students without d/h fig. . comparison of students experiencing stressful circumstances directly related to covid- in early spring . the circumstances assessed were major loss in own income, major loss in family income, oneself in quarantine, family member placed in quarantine, quarantine or other covid- effect leading you to feel isolated, conflict/tension within household members due to covid- . the x axis lists relevant concerns, along with the number of students in each category. for example, in the case of income loss, students with disabilities/health concerns (or % of those students) were concerned about income loss, while students without disabilities/health concerns ( % of those students) were worried. stressors attributed specifically to covid- (i.e. recent stressors) shown in figure . here we see that students with disabilities/health concerns report higher levels of chronic discrimination (e.g., experiencing demeaning remarks or forms of unfair treatment) and higher exposure to major life adversities (e.g., a serious interpersonal conflict, early life or recent maltreatment). students with disabilities/health concerns also report more covid-related concerns. notably, both student groups reported comparable level concerns about isolation, and comparable loneliness. given the greater levels of adversity exposures and variety that students with disabilities/health concerns face, we anticipated that students with disabilities/health concerns would experience increased mental health problems. however, both groups of students experienced comparable levels of current perceived stress, depression, and anxiety at the time they filled out the survey, as shown in table . it is notable that, in comparison to the other mental health measures, students with disabilities/health concerns did have significantly higher scores on the ptsd (distress) scale [ ] . we delve more deeply into this result in the next subsection. [ ] . ( . ) . ( . ) . cesd (depression) [ ] . ( . ) . ( . ) . stai (anxiety) [ ] . ( . ) . ( . ) . ptsd (distress) [ ] . ( . ) . ( . ) . ** table . mean (standard deviation) of scores on mental health scales for students with disabilities/health concerns (d/h) and without disabilities/health concerns (no d/h) . t-test values and significance levels are indicated. mann-whitney u tests yielded comparable results. significance is marked as * * < . , ** < . , *** < . . to further explore these results, we undertook a more nuanced examination of student responses. figure shows the items which had the highest level of endorsement from students with disabilities/health concerns. these items are consistent with domains of ptsd reflective of general psychological distress (specifically, domains d and e [ ] ). that is, the items that were most frequently rated as highly concerning by students with disabilities/health concerns appear to be reflecting symptoms of hyperarousal and agitation-such as difficulty concentrating, trouble sleeping, and having negative feelings. students were also comparatively cut off from others in this time of isolation, and indicated that as troubling. one possible explanation for the ptsd group difference described above is that our sampling process in purposefully included more people with disabilities/health concerns and other vulnerabilities. to address this, we looked at the and data just for students who had participated in both the and studies (a total of students, of whom have disabilities/health concerns). we first examined whether our results changed when we only looked at the students who participated in note that while the significance is higher here, the means for students without disabilities/health concerns are lower than for students with disabilities/health concerns in both and . this study provides an early snapshot of the concerns and vulnerabilities of undergraduate students with disabilities/health concerns within the early-stage context of the covid- pandemic. such students expressed considerable concern about the educational and financial impacts of covid- . at this early stage of covid- , we did not see higher levels of self-reported depression, anxiety, stress or loneliness. however, students with disabilities/health concerns did report overall high levels of stress exposure and exposure to covid- related adversities, and we saw evidence of associated distress. by comparing students with and without disabilities/health concerns, we gain insights about the unique vulnerabilities of students with disabilities/health concerns in the covid- context. they brought significantly deeper histories of both discrimination as well as serious major life adversity exposures than non-disabled students to this context. in addition, our results show that students with disabilities/health concerns are already experiencing covid- related stress. students reported higher or equal exposure to all of the covid- specific stressors we measured than their peers without disabilities/health concerns. we also found early signs of distress, particularly difficulty concentrating, insomnia, and isolation, all understandable reactions to conditions of unpredictability and lack of control [ ] . the timing of the surveys (early in the covid- crisis) leaves open the possibility that the effects we see are due to different stress exposures between students with and without disabilities/health concerns and not specifically to covid- . however, our comparison of the students who provided survey data in both and suggests that exposure to discrimination and distress both increased this year and that our data reflect increased vulnerability of students with disabilities/health concerns in the covid- context. prior evidence has established that students entering higher education with adversity backgrounds are at elevated risk of worsening mental health [ ] . subsequent stress exposure adds to and, in some cases, may exacerbate the effects of earlier adversities [ ] . on the other hand, measures of stress, anxiety, depression, and loneliness all show no change (see tables and ). this could also indicate resilience in the face of these stresses, many of which are areas where people with disabilities may have prior experience [ ] . students with disabilities/health concerns in our study report worries about courses going online, and serious consequences of the move online including receiving worse grades, not being able to meet academic requirements online, and having admission to their chosen major impaired. in addition, our study shows that students are not only concerned about online courses, but also exposed to a variety of stressors from discrimination to financial concerns. this suggests that more accessible online education tools should be designed to consider a wider range of concerns, which can potentially exacerbate the impact of barriers to access. prior work has argued for the importance of considering context in the design of accessible technologies [ ] . rather than simply making online course materials more accessible, online instructors may need to support students who are coping with multiple stressors outside of class. for example, this might include designing for asynchronous participation, or redundant assessment that is robust to occasional absences. further, in the context of a pandemic, best practices are to convey safety, calm, comfort and connectedness [ ] . if educators and educational technology can strive to provide a calming, connecting experience, they can support students rather than compounding their stress. our choice to combine people who identify as disabled with people who report themselves as having significant health concerns is driven by the relatively high numbers of people with health concerns who do not identify as disabled [ ] , even though they may experience accessibility barriers. moreover, this group comprised fewer than % of the students with disabilities/health concerns and in an analysis comparing subgroups of students with disabilities/health concerns, we did not see major differences in our results. there are philosophical questions raised by this choice about who "counts" as disabled. our view was that, relative to our study's goals, this level of health concern rendered these students comparably vulnerable in the covid- context. that said, we recognize that other sources may use differing definitions. finally, we note that we have a relatively small and non-representative sample (for either seattle or nationally with respect to undergraduates). this sample reflects our efforts to reach more vulnerable students and thus our results may be most relevant to students with such vulnerabilities. this article is a first look at the impact of covid- on students with disabilities, and as such, it illuminates a range of needs not yet well documented. it also helps generate questions for further inquiry. understanding how covid- affects students with disabilities/health concerns can help us to identify patterns of concerns, stress and indicators of mental health, and provide further steps to take or consider in order to respond to an unexpected global health pandemic. our findings show that students with disabilities/health concerns were more worried about the outcomes of the unanticipated change to online learning than their peers. in addition, during our study, students with disabilities/health concerns experienced more covid- related adversities and distress. as pandemics (as well as other major stress conditions) continue over time, additional stressors begin to arise (e.g., loss of income, lack of healthcare access, caring for others [ , ] ). this could in turn translate to larger impacts on the wellbeing of students with disabilities/health concerns. in the future, we hope to compare students' response to covid- further into the epidemic to the data described in this paper. further, we plan to conduct interviews to develop a more nuanced, qualitative picture of these impacts. to conclude, we argue that just as students with disabilities belong in higher education, accessibility research belongs in higher education. it is time for the accessibility community to expand our work studying technology use and developing technology to support students with disabilities in higher education. we hope that these insights into the student experience demonstrate how important it is to learn how higher education fails and succeeds to support students with disabilities, and where technology can play a role in improving this. the macarthur scale of subjective social status the cohen-hoberman inventory of physical symptoms: factor structure, and preliminary tests of reliability and validity in the general population the covid- response must be disability inclusive -ncov epidemic: address mental health care to empower society preparing for and responding to pandemic influenza: implications for people with disabilities covid- 's isolated world is the norm for people with disabilities a global measure of 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the general population understanding mental ill-health as psychosocial disability: implications for assistive technology ucla loneliness scale (version ): reliability, validity, and factor structure preparation. from microaggressions to major problems. cscw (in preparation) passively-sensed behavioral correlates of discrimination events in college students mental health consequences of infectious disease outbreaks disability across the developmental life span: for the rehabilitation counselor manual for the state-trait anxiety inventory covid- : the impact of a pandemic on mental health sustained increased consumption of cigarettes, alcohol, and marijuana among manhattan residents after studentlife: assessing mental health, academic performance and behavioral trends of college students using smartphones the ptsd checklist for dsm- (pcl- ). scale available from the national center for ptsd at www. ptsd. va the impact of stress on body function: a review key: cord- - ve heyb authors: maulik, pallab k.; thornicroft, graham; saxena, shekhar title: roadmap to strengthen global mental health systems to tackle the impact of the covid- pandemic date: - - journal: int j ment health syst doi: . /s - - - sha: doc_id: cord_uid: ve heyb background: the covid pandemic has been devastating for not only its direct impact on lives, physical health, socio-economic status of individuals, but also for its impact on mental health. some individuals are affected psychologically more severely and will need additional care. however, the current health system is so fragmented and focused on caring for those infected that management of mental illness has been neglected. an integrated approach is needed to strengthen the health system, service providers and research to not only manage the current mental health problems related to covid but develop robust strategies to overcome more long-term impact of the pandemic. a series of recommendations are outlined in this paper to help policy makers, service providers and other stakeholders, and research and research funders to strengthen existing mental health systems, develop new ones, and at the same time advance research to mitigate the mental health impact of covid . the recommendations refer to low, middle and high resource settings as capabilities vary greatly between countries and within countries. discussion: the recommendations for policy makers are focused on strengthening leadership and governance, finance mechanisms, and developing programme and policies that especially include the most vulnerable populations. service provision should focus on accessible and equitable evidence-based community care models commensurate with the existing mental health capacity to deliver care, train existing primary care staff to cater to increased mental health needs, implement prevention and promotion programmes tailored to local needs, and support civil societies and employers to address the increased burden of mental illness. researchers and research funders should focus on research to develop robust information systems that can be enhanced further by linking with other data sources to run predictive models using artificial intelligence, understand neurobiological mechanisms and community-based interventions to address the pandemic driven mental health problems in an integrated manner and use innovative digital solutions. conclusion: urgent action is needed to strengthen mental health system in all settings. the recommendations outlined can be used as a guide to develop these further or identify new ones in relation to local needs. page of maulik et al. int j ment health syst ( ) : community structures across the globe is potentiating a major international mental health crisis [ ] [ ] [ ] [ ] . the mental health impacts of covid- can be varied and severe and have been outlined recently [ ] . the effect of this stress can vary from mild symptoms related to physiological or psychological functions such as sleep disturbance or low mood, mild stress for short periods of time that do not need any specific treatment and resolve when the primary stressors such as job loss or illness in family or poor social support are taken care off, to the more severe syndromal mental disorder which may need formal treatment from a mental health professional [ ] . anxiety, depression, increased alcohol and substance use, irritability, anger, insomnia and increased risk of suicide have been reported, as have been risk factors for mental disorders such as loneliness, domestic violence, physical violence. individuals with existing mental disorders such as alcohol and substance use, cognitive impairment and dementia, childhood psychiatric disorders and adults needing long term follow up have been particularly affected due to lack of continued psychiatric care services and fragmentation of the existing health systems to provide adequate care. in addition, the direct impact of covid on mental illness of those infected or health workers involved in care of those infected is also significant, and is often precipitated due to increased stigma, social isolation and quarantine [ ] . all this is even more complicated due to the socioeconomic impact of the pandemic on the lives of the poor and most disadvantaged communities such as homeless and migrant workers. the overall mental health impact of the pandemic is not transient but likely to continue for a long period even after the pandemic ends, as is evident from prior research on such severe epidemics [ , ] . researchers have highlighted the need for focussed research that should be funded related to the impact of covid- [ ] . most mental health systems across the world have been woefully inadequately funded, planned, organised and delivered given the major global burden of mental disorders [ ] . the codid- pandemic has added even greater challenges. with shrinking economies, policy makers will have to rebalance prioritizing mental health services against other health service investments. the ability to react and take appropriate decisions will depend on the existing resources and infrastructure. these decisions will then need to be matched up against the impact of the pandemic-not only on mental health, but to the overall health of the country, as well as the socioeconomic determinants. thus, it becomes important to have a better understanding of what steps can be taken in such scenarios to make most efficient use of the limited resources. at the same time new research should align with the changing paradigm of mental health care delivery which may have to rely on use of digital solutions [ ] , identify risk factors that are particularly relevant to precipitating mental disorders in the face of this pandemic, and develop and implement scalable interventions to mitigate the impact of the infection on mental health across different communities and different settings. in this context, the aim of this paper is to outline a roadmap to guide countries to strengthen mental health systems to tackle the increasing burden of mental disorders. using both world health organization's mental health action plan - [ ] and the who health systems strengthening framework [ ] , we propose a set of recommendations from the perspectives of policy makers, service providers and research funders, organised into low-, middle-and high-resource scenarios. while the recommendations encompass systematic and structural actions that are relevant to building a strong mental health system per se and is essential to the current pandemic as in any other crisis, embedded within them are some more specific aspects that are particularly relevant to the covid crisis, and these have been indicated separately. the eventual objective is to "build back better" [ ] . table shows recommendations for policy makers in areas of leadership and governance, finance, policies and programmes that include long term care and needs of vulnerable populations. table outlines recommendations for service providers and other stakeholders involved in care of those with mental health problems. it focuses on providing equitable and accessible community-based mental health services and clinic-based services for those needing such care, build capacity by training primary care health workers to provide community-based services, implement community-based mental health prevention and promotion programmes, strengthen civil societies to support the government mental health service provision, and support programmes and policies specifically to manage workplace related stress which will be a major issue given the economic woes and changing paradigms of limited workforce or working from home. table outlines recommendations for researchers and research funders to align research to strengthen information systems, gather more epidemiological data and conduct robust interdisciplinary interventions that are scalable, use innovative designs and leverage technology to develop some interventions to facilitate service delivery and improve supply chain of psychotropic medications at primary care levels and leverage the power of social media to deliver interventions. technology strengthen civil societies *civil societies identify key areas where they can contribute and pitch into support the overall government plan to manage mental health problems during the covid pandemic *civil societies involved in mental health service delivery or research or advocacy are identified and integrated within a government database; especially those with the ability to support multiple health conditions including mental health should would be beneficial the databases of civil societies allow the administrators to identify strengths of each organization, its reach, focus, and key resource person(s) government plans their mental health alleviation programmes keeping civil societies in the loop and takes their opinions government allocates ring-fenced funds to support activities undertaken by civil societies where it by itself cannot function effectively, be it research, program implementation, or advocacy *a registry of civil societies is advanced enough to allow for an easy two-way communication between them and the government *appropriate funds to support civil societies led programmes are present and those are planned in consultation with the government civil societies per se can access resources and roll out programmes as per their strengths while keeping the overall focus on managing the impact of the pandemic the collaborations between civil societies and government is streamlined; the government provides oversight to local and regional programmes that are essentially implemented by civil societies *civil societies and government are equal partners in delivering care or conducting research during this pandemic *civil societies working at national, regional or local levels are adequately funded to support not only their own activities but support government efforts to overcome the covid pandemic develop innovative solutions to improve mental health systems; support technologyenabled solutions to support service delivery; identify strategies to enable more efficient supply chain logistics models for medicines; use of social media to deliver interventions on mental health promotion *develop technology-enabled solutions to conduct research and gather data avoiding in-person contact as much as feasible, while ensuring appropriate data security and privacy *identify culturally relevant evidence-based applications to gather data on mental health outcomes and increase access to care conduct health systems research to investigate how supply of psychotropic medications at community level can be accomplished use social media platforms to not only link researchers but also develop interventions based on use of social media *better ability to link secondary data from other sources with primary data using big data analytics *service use involves digital technology, interactive voice messages, video games, virtual reality *advanced methodologies using artificial intelligence driven analytics allow development of risk profiles in real time and identify predictive models led solutions need to be ramped up especially in these conditions where in-person data collection is limited considerably. mental health is one of the most neglected areas of health. the covid pandemic and any similar challenges in future, should be tackled along the lines of a humanitarian emergency [ ] . even during more normal times, addressing mental health needs as part of the sustainable development goals has been a major challenge [ ] . the covid crisis has led to a fragmentation of existing health systems across the globe, which will have a profoundly negative and cascading effect on mental health not only in coming months, but for some years, and this has been identified even at the united nations [ ] . not only will covid lead to a surge in mental health needs in the community [ , ] , but the way it has crippled the health systems globally to address the need of any other health problem, it is likely to have a devastating effect on the longer term needs of people who need care for mental illnesses [ ] . it becomes necessary to identify strategies to strengthen health systems to overcome these challenges. the best way to tackle mental health impact is to not limit it to overcoming the immediate mental health crisis, but to embed its management within the larger health system that can impact the lives of individuals globally or across large regions. in this paper we have focused on low, middle and high resource settings and indicated how they can re-orient their health systems, service provision and research according to the need and available resources. this approach applies as much to countries as it does to regions or health administrative units within countries, given the very large disparities in needs and resources that are common in countries worldwide. we present the recommendations in tables , and not as separate and unrelated proposals, but as part of an overall integrated approach to health system strengthening, which should be adapted to specific local needs and modified in relation to available resources. policy makers will play a major role in providing leadership to any programmes and policies that they develop and implement. it is therefore imperative that they are both educated about the mental health needs during this crisis and supported by academicians and mental health professionals to develop robust policies and programmes to address the increased burden of mental health. while there will be a requirement to address some immediate mental health needs and provide psychosocial support in line with the iasc guidelines [ ] , they should plan on developing more robust policies and programmes to build a system that is more holistic, encompasses intersectoral collaborations, protects the rights of the individuals, has deliverables that are based on evidence, and is able to deliver care over a long time. these policies and programmes should be supported by adequate funding and tap into existing private and government sources. insurance mechanisms should ensure that adequate financial support is available for individuals to seek mental health care as per need. this may need a paradigm shift in the way the insurance system is organized as most often mental disorders are excluded from their remit. in united states of america, telehealth parity has been introduced in many other states post the covid crisis to ensure providers get same payment for teleconsultations as in-person consultations, thus enabling service delivery [ ] . telepsychiatry has also resulted in expanding home-based care for conditions like substance use disorders in the united state, which earlier were only available if comorbid physical disorders were present. policy makers should support development of teleconsultations and robust electronic health records systems to enable remote care delivery. the mental health budget allocation should reflect the change in the burden due to the crisis and the government should be open to exploring innovative ways to build in mental health related budget into the relevant sectors, for example, addressing job security, providing affordable homes for migrant workers, building shelters for women or children facing abuse, enhancing care for the elderly and those with dementia, could help in reducing the burden considerably. strategies should be locally relevant and keep needs of vulnerable populations, inclusivity, stigma reduction, and rights-based approaches at the core of their principles [ ] . the key elements that service providers should keep in mind are to develop a model that is community-based and involves training and upskilling of primary health workers and non-mental health professionals to both identify and deliver basic mental health care based on principles laid down by existing guidelines [ ] , and drawing on basic tenets and the detailed guidance of the mhgap programme of the world health organization. psychological therapies can be tailored to the level of skilled resources available. the level of specialized care provided should be informed by local factors and available resources. some of those are number of mental health trained staff and their skills level, types of mental health facilities available, for example primary, secondary or tertiary care, budgets available to support services, availability of communitybased support services to cater to specific needs of individuals with significant disabilities, support services for families and caregivers, role of multi-sectoral agencies to support mental health care such as employment agencies, housing, elderly welfare, child welfare services, education. services provided should be locally tested and culturally relevant. needs of vulnerable populations should be specially kept in mind. the services should be both accessible and equitable, and one key strategy to ensure that in times of physical distancing could be increased use of technology enabled services such as e-health, m-health, telemedicine [ , ] . this should encompass screening, service delivery, training of health workers and monitoring. a key aspect is to maintain physical distancing while ensuring continuity of care. to do so telemedicine services and linking of patient and provider data on health information systems that enables tracking of a patient's health remotely is necessary. the system should allow both the patient and health providers to interact with each other either through video chats or dedicated phone lines and be interactive enough to allow the patient to upload their progress, treatment adherence and complications online and the provider can respond to those in real time. reports from italy, underline how mental health services were prioritized in the face of the covid pandemic by identifying essential mental health services, providing medications to those with substance use disorders, enabling teleconsultations [ , ] . even in low resource settings such as in india, teleconsultation for mental health issues is being regularly provided by many tertiary care centres, though there is a lot of scope for improvement. civil societies have also set up teleconsultation to care for emergency situations [ ] . in china, there were more specific challenges as being the first country to face the pandemic, there were no prior experiences to follow, but restructuring of service at different levels and delivering a mix of online and offline services were identified as critical for ensuring continuity of care, but new ethical challenges related to teleconsultations and practical problems related to implementation of new strategies had to be overcome [ ] . availability of psychotropic medicines should be facilitated by ensuring that the supply-chain is maintained, and governments need to invest for that specifically in low and middle resource settings. civil societies should be encouraged to collaborate with government agencies and work in both strategizing and service delivery and the government should allocate ring-fenced funds for such activities. labour organizations and employers should be adequately trained to identify specific mental health needs of individuals in this pandemic, but also encouraged to revisit their policies to ensure that their laws are employer friendly but also allowing for industry growth. addressing the mental health needs of employees is critical even in normal times [ ] and during this added challenge it may be a major factor to alleviate the burden as employees and employers both grapple with new situations of working from home, restricted office attendance, staff layoff, reduced productivity, and reduced remunerations. the focus of research and the level of sophistication of such will vary across low, medium and high resource settings. even within a high-income country there may be a need to understand how to deliver basic services or ascertain prevalence or incidence of mental disorders in some regions with lower resources. in order to capture the true burden of covid on mental health, it is vital that information systems to gather such data is strengthened across all settings. it is important to create a system where data from multiple sources can be linked to build an aggregate database involving both clinical and social determinants. an initiative on this, countdown global mental health is already underway [ ] . research exploring neurobiological correlates, behavioural concepts that determine how stigma and discrimination plays a role in help seeking in covid affected individuals, effect of socioeconomic policies on mental health, mental health effects on different populations by age groups, gender, migrant and labourer communities, homeless, health workers, etc., are all relevant areas of further investigation [ , , ] . research should also explore newer strategies using machine learning and artificial intelligence to build predictive models to inform risk profiles for future pandemics and determine possible phenotypes that could allow service providers to modulate care and overall outcomes. the role of artificial intelligence, digital tools to collect real-time data, combining online and off-line data with in-person data needs to be enabled to enrich research data to support better care models [ ] . we believe that urgent action is needed to strengthen mental health system in all settings in view of enhanced need for mental health care and decreased access during and beyond the covid- pandemic. the roadmap draws upon key sources and accumulated knowledge of mental health systems globally to provide a perspective on practical steps to strengthen mental health systems across the world. the strategies outlined here 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abstract the medicine and public health initiative (mphi) was created jointly years ago by the american medical association and the american public health association to bridge the nearly century-wide gulf between the respective disciplines. we review the history of mphi and its growing significance in light of recent terrorism events. we report on current mphi activities by examining three bellwether states—california, florida, and texas—as well as international sites. upon its inception, mphi was rapidly embraced and nationally disseminated. sustainability years later in the post- world requires renewed commitment by all collaborators. in order to meet the numerous health challenges facing our nation, from terrorism to chronic disease, and for mphi to be successful, medicine and public health must work in tandem. t he medicine and public health initiative (mphi) was created jointly by the american medical association (ama) and the american public health association (apha) to bridge the near century-wide gulf between the disciplines of medicine and public health. these differences, which have been separating the houses of medicine and public health in the united states going back to the late th century, have grown during the th and early st centuries. since , when abraham flexner published his seminal work on u.s. medical education, the practice of medicine has been predominantly grounded in the biomedical model and has focused its resources on the individual patient and physician. public health, meanwhile, has relied more on the science of epidemiology, and has adopted population-based approaches to resolve societal health issues, emphasizing prevention. ironically, former ama leaders were among the founders of the apha in , and many of the pioneers in american public health were respected physicians. yet, despite their shared origin and intermittent successful efforts at joint collaboration, for the past hundred years the two disciplines have occupied largely parallel health universes. as a vivid example, physicians formally trained in public health, individuals with a stake in both worlds, appear to account for Ͻ % of all u.s. physicians. although they are the most profoundly affected by the limited interaction across the disciplines, the relative scarcity of preventive medicine specialists has impaired their ability to bridge the cultural divide without additional partners. with escalating healthcare costs, persistent growth in the ranks of the uninsured, increasing emphasis on healthcare quality and outcomes, epidemics of chronic diseases, ever-widening health disparities, and outbreaks of new emerging infectious diseases, there is growing awareness that greater collaboration between the two professions is not an option, but a pressing mandate. moreover, because of these shared challenges, opportunities for partnership today are even more auspicious. nonetheless, underestimating the cultural and institutional barriers separating medicine and public health discounts the enormous labor ahead to bridge these historic gaps. but, in the wake of the threats posed by terrorism, there is an even greater societal imperative, because an optimal preparation for, and response to, terrorist actions must include close coordination between medical practice and public health. medical professionals play an essential role in surveillance of public health diseases. for example, who can predict what greater tragedy may have emerged from the anthrax events if an alert south florida physician had not notified his local health department? in order to highlight the importance of strengthening this partnership, this paper reviews the -year history of the mphi, discusses some of the current mphi activities in three bellwether states (texas, florida, and california), as well as internation-ally, and issues recommendations for a renewed partnership between the fields of medicine and public health. in march , for the first time in the modern era, the presidents of the ama and apha met on behalf of their organizations to discuss mutual interests. the precursor to this historic meeting was a keynote lecture in delivered by then ama vice president m. roy schwartz, md, entitled "medicine and public health: a costly estrangement." the meeting proved catalytic, and a second meeting on the importance of the new medicine and public health partnership followed in washington dc. a broad group of medicine and public health organizations was represented, including the association of academic health centers, the association of schools of public health, the association of american medical colleges, the association of state and territorial health officials, and the national association of county and city health officials. a task force emerged, which met from to to define the scope of mphi. it recommended seven critical shared agendas: ( ) engaging the community, ( ) changing the education process, ( ) creating joint research efforts, ( ) devising a shared view of health and illness, ( ) working together in healthcare provision, ( ) jointly developing healthcare assessment measures, and ( ) translating initiative ideas into action. , in a follow-up to the task force's work, a national congress was convened in chicago during march , with Ͼ delegates from across the nation in attendance. they represented a broad mix of interests from medicine and public health practice, academic leaders from both disciplines, and the insurance industry. the focus of the national congress was small group work designed to build action steps for future mphi activity upon the participants' return home. ultimately, states were funded via a competitive process under the rubric of the cooperative actions for health program provided through the robert wood johnson (rwj) foundation and the federal agency for health care policy and research. the university of texas-houston health science center received funding to serve as the national mphi program office. a profile of each state's project, as well as lessons learned through a formal evaluation, are documented in an mphi monograph. there were some impressive accomplishments from these early grants, including some that have stood the test of time. for example, in new york improvements in the reporting of infectious diseases to public health authorities led to the early identification of the first outbreak of west nile virus in the western hemi-sphere. additionally, a bicycle helmet campaign in washington state increased helmet usage rates over %. however, even with these notable successes, many states lurched forward in halting steps. the new york academy of medicine was commissioned to examine the history of collaboration between medicine and public health, and to search for models across the nation in which collaboration was successful. a total of discrete examples of collaboration were identified; each of these "cases" was categorized into one of six groupings of synergistic results: ( ) improved health care by coordinating services for individuals; ( ) improved access to care by establishing frameworks to provide care for uninsured and underinsured; ( ) improved quality and cost effectiveness of care by applying a population perspective to medical practice; ( ) used clinical practice to identify and address community health problems; ( ) strengthened health promotion and health protection by mobilizing community campaigns; and ( ) shaped the future direction of the health system by collaborating around policy, training, and research. a monograph describing their findings was developed and sent to all medical schools in the united states. subsequently, a pocket guide tool was created and made available though the internet. in the course of only short years, mphi developed from a concept resonating with faculty and leadership mainly at one health sciences center, into a flexible model with widespread dissemination and active participation in states and localities across the country. although mphi was embraced in some states and localities, it was unable to bridge the cultural and institutional divide in others. perhaps the chief hallmark of mphi was its reliance on and recognition of locally initiated activities. mphi at the state and national level was established to provide infrastructure and support for innovative problem-solving approaches developed locally, and to share relevant information with others similarly situated. but by , even as meaningful activities continued in many local venues, changes in organizational leadership and shifting association priorities at national, state, and local levels, foreshadowed difficulty in sustaining the momentum of mphi. the shocking events of september and the fall of have served notice of the necessity to rekindle the fires of collaboration between medicine and public health. certainly, it is equally true that the burden of chronic diseases with their complex multifactorial etiology have created incentives for the curative and preventive disciplines to form effective partnerships. however, there is an immediacy to the specter of see related commentary on page . terrorism which serves notice that anything less than full commitment to collaborate from all sectors of the healthcare system exposes the nation to unjustifiable danger. in october , spearheaded by the presidents of the ama and apha, several organizations reiterated their dedication to the purposes of mphi at a meeting in houston tx. a new, more focused agenda emerged, reflecting the health concerns facing our nation, with an emphasis on disaster preparedness and readiness training to address the imminent terrorism threat. activities were also envisioned to reduce health disparities and to improve patient safety. ongoing commitments to promote healthcare access for the uninsured were renewed. the presidents of both organizations made mphi a cornerstone of their presidential platforms. in the months since the regeneration of the mphi, efforts have continued on the national and state level. however, another promising trend is also emerginginternational interest in mphi. encouraging collaboration has taken place in china, the united kingdom, canada, and mexico. during the and apha annual meetings, sessions were held to update national as well as state, local, and international partners on the current status of mphi activities. several states, notably california, florida, and texas have maintained their longstanding commitment to a partnership between medicine and public health, while other states appear to be interested in expanding their commitment to this initiative. below, we summarize mphi history and activities in these states and internationally. in california, an mphi steering committee has been meeting quarterly since . its inception followed a statewide mphi conference sponsored through a rwj foundation mini-grant. what began as a meeting between california medical association leadership and local health officials has evolved into a much more inclusive steering committee with attendance by numerous community-based organizations as well as its charter members, medicine and public health. the focus of the california mphi steering committee has been on joint legislative issues and policy concerns. moreover, it fills a communication vacuum on "hot button" issues, and prompts joint action as warranted. discussion is frank and open, often resulting in a consensus. even when agreement cannot be reached, there is a greater basis for mutual understanding among the participating organizations. although there are no formal by-laws, member groups abide by a memorandum of understanding. members have agreed that high-level policy discussion across their organizational boundaries is the primary contribution that the steering committee makes. but early in its genesis, other interest groups came to the mphi table and have been successful medicine and public health progeny. for instance, an environmental health interest group formed and recently held a statewide conference. likewise, an adult immunization task force has been established and is currently working to increase immunization rates among the adult population of the state. with support from the rwj foundation, florida convened a statewide medicine and public health summit in . the summit was preceded by data gathering through statewide focus groups. follow-up initiatives were centered on building strong working relationships between county medical societies and local county health departments. toward this end, meetings were held in the four quadrants of the state. numerous memoranda of agreement resulted, heralding an improved local understanding of respective roles of the medical and public health communities. in july , a florida mphi summit was held with national, state, and local medicine and public health leaders in attendance. another example of the collaboration between the florida medical association (fma) and public health was the creation of a separate, free-standing department of health, carved from the largest health and human services superagency in the united states. if not for the involvement of organized medicine in advocating for the new department (it was a top priority for the fma president), public health would still be embedded in a less-effective mega-agency. more recently, advocates from medicine and public health together sought support to create a museum of medicine and public health. the building, the original state board of health structure in jacksonville fl, has been restored, and was dedicated in november . finally, both medicine and public health have worked together to help solve one of the most dire problems in health care, access to health services for indigent patients. in order to increase physician involvement in charity and low-income care medicine and public health coordinated an intense lobbying campaign for passage of the access to healthcare act in the florida legislature. this statute now provides for medical liability protection through sovereign immunity for health professionals who volunteer to offer services to low-income uninsured and underinsured residents in the state. donated health services reached the $ -million per year level within just a few short years after startup, and have provided over $ million in total uncompensated care in the state. texas was the site of the inauguration and early formation of the mphi movement, and was among the recipients of the rwj foundation cooperative actions for health program grants. the texas project was a partnership of the texas medical association, texas public health association, and the texas department of health. the partners conducted state and local level continuing education programs to focus medicine and public health collaborative efforts on health priorities within texas. early accomplishments included courses on bioterrorism, as well as several featured publications on mphi. in addition, texas has begun to explore a collaborative program in mexico, building on a student-led initiative at the la salle university medical school in mexico city. the program's emphasis is student-led outreach to rural communities to provide public health, medicine, nutrition, and mental health services. recent events like the severe acute respiratory syndrome (sars) outbreak have demonstrated that health must be viewed through a global lens. appropriately, international interest in mphi is increasing, with encouraging collaboration occurring in china, the united kingdom, and mexico. in january , a memorandum of understanding was signed that links the china preventive medical association with the national mphi. a joint conference was held in september in beijing, producing a "call to action" for local and national mphi pilot projects within china. in order to build on the foundation laid in a decade of work, and to strengthen the relationship between medicine and public health, we propose the following recommendations. first, medicine and public health need to continue to visibly renew their shared commitment to partnership through mphi, in a manner that demonstrates enhanced collaboration and joint involvement of the disciplines. this is best done at the national level by the leadership of key professional organizations such as the ama and apha. ironically, these same organizations must also address internal institutional barriers that de-emphasize partnership and collaboration across the medicine-public health divide. in addition, vision and energy must emanate from the primary organizations representing preventive medicine: the american college of preventive medicine and the association of teachers of preventive medicine. leadership in public organizations is also critical. of note, the centers for disease control and prevention (cdc), the leading federal public health agency in our country, is modeling just such action. prominently featured in its new "futures initiative" designed to shape its goals and organizational structure, cdc has made reaching out to the practicing medical community a cornerstone of its new strategy. cdc showcased this commitment by co-hosting with the ama the first national preparedness congress in . across the nation, mphi has been most successful in locations where a professional organization has assumed ownership and taken charge. it is time for more organizations to step forward and promote a shared agenda. second, communication across disciplines must be facilitated by a common lexicon and a shared understanding of principles. this should be accomplished through professional education by integrating elements of public health and medicine into each other's curriculum. the good news is that we have already seen some progress in this arena. schools offering combined md-mph degrees have more than doubled since , and now total . this has been accompanied by an increase in the numbers of participating students. however, medical school curricula are already overcrowded due to required content and the explosion of scientific knowledge; for that reason, it is important to integrate public health concepts into existing courses. several frameworks exist for accomplishing this within the current educational milieu. for instance, the association of american medical colleges has made specific recommendations to emphasize public health principles regarding bioterrorism in medical schools. the association of teachers of preventive medicine has developed an inventory of core competencies for disease prevention and health promotion that underscore critical public health concepts within medical education. building on these efforts, recent work has been completed to extend clinical prevention concepts across health professional education as part of the healthy people planning. conversely, the same holds true for imbedding medical concepts into training programs in public health, as was recently recommended by the institute of medicine. this is likely to be challenging, given the broad spectrum of graduate public health education and the multiple and divergent backgrounds of the student population. nonetheless, despite its inherent complexity, this should be a high-priority challenge for the association of schools of public health and the council on linkages between academia and public health practice. cross-referencing the work of the healthy people curriculum task force for comparison within public health curricula is a logical starting point. alter third, we renew the call for research into effective strategies that improve understanding and overcome barriers across the medicine-public health chasm. what methodologies enhance interaction, integration, partnership, or collaboration between the disciplines? although important groundwork was laid by the new york academy of medicine, considerable research remains to be completed in order to establish an evidence base for successful interaction. this may be promoted by revisiting early mphi partnerships that have demonstrated sustained collaboration and success. similarly, there is a need to explore optimal approaches to disseminating best practices, especially ones emerging from local communities employing innovative techniques to tackle long-standing problems. schools of medicine and public health, in partnership with the practice community, would make excellent laboratories for such research. although national leadership is crucial, local ownership and leadership are imperative as well. our collective experience has shown us that efforts demonstrating added value to the community are rapidly embraced. it remains for the local medical and public health communities to translate the mphi into meaningful action, whereby the lives and well-being of our fellow citizens are measurably enhanced. recent events have offered the opportunity to again strengthen the collaboration between medicine and public health. the contour of the future health landscape is our collective responsibility. medicine and public health must together shape that vista. no financial conflict of interest was reported by the authors of this paper. it's about time: the medicine/public health initiative antagonism and accommodation: interpreting the relationship between public health and medicine in the united states during the th century new york: carnegie foundation for the advancement of teaching medicine and public health: the power of collaboration a threat to the public health workforce: evidence from trends in preventive medicine certification and training medicine and public health: pursuing a common destiny the medicine and public health initiative policy statements of the american medical association concerning the medicine and public health initiative carrying out the medicine/public health initiative: the roles of preventive medicine and community-responsive care cooperative actions for health programs: lessons learned in medicine and public health collaboration pocket guide to cases of medicine and public health collaboration paper presented at: meeting of the florida medicine and public health initiative steering committee improving access to care for the underserved available at: www.cdc.gov/futures/outside-in.htm md-mph opportunities at u.s. medical schools. paper presented at prevention training future physicians about weapons of mass destruction: report of the expert panel on bioterrorism education for medical students. washington dc: association of american medical colleges prevention for the st century: setting the context through undergraduate medical education clinical prevention and population health curriculum framework for health professions who will keep the public healthy? educating health professionals in the st century key: cord- -ekv pop authors: andersson, tommy; erlanson, albin; spiro, daniel; ostling, robert title: optimal trade-off between economic activity and health during an epidemic date: - - journal: nan doi: nan sha: doc_id: cord_uid: ekv pop this paper considers a simple model where a social planner can influence the spread-intensity of an infection wave, and, consequently, also the economic activity and population health, through a single parameter. population health is assumed to only be negatively affected when the number of simultaneously infected exceeds health care capacity. the main finding is that if (i) the planner attaches a positive weight on economic activity and (ii) it is more harmful for the economy to be locked down for longer than shorter time periods, then the optimal policy is to (weakly) exceed health care capacity at some time. a central part of many countries' policies to tackle the covid- pandemic has been to "flatten the curve." that is, a more gradual uptick of infected persons prevent health care systems to be overburdened and save human lives. for example, greenstone and nigam ( ) (building on ferguson et al., ) estimate that , lives in the us could be saved by social distancing policies assuring that intensive care units are not overwhelmed during the peak of the covid- pandemic. at the same time, slowing down disease transmission appear to cause large economic costs due to a fall in both consumption and production. fernandes ( ) estimates the costs of the covid- outbreak for countries under different scenarios, and finds a median decline in gdp in of . percent, but that gdp can fall by more than - percent in some scenarios. many have therefore concluded that the covid- outbreak involves a key tradeoff: a higher spread-intensity is advantageous for economic activity, but disadvantageous for population health. this paper analyzes the trade-off between reduced economic activity and population health in a simple and tractable model. in contrast to most previous work, we simplify the epidemiological model by only allowing two states: individuals are either susceptible or infected. this modelling choice implies that the whole population is eventually infected and that there is no death or recovery from the infection. this is overly simplistic for studying disease transmission more generally, but we believe it can be an useful simplification when integrating epidemiological and economic models. in particular, our model allows the social planner to influence how quickly the infection spreads, and therefore also the economic activity and population health, by choosing a single parameter. a lower spread-intensity increases economic activity, but harms population health if the number of infected at the peak of the epidemic exceeds health care capacity. we first show that if the social planner only puts weight on population health, health care capacity will never be exceeded, which is in line with arguments behind "flattening the curve" policies. the same conclusion holds if the social planner is also concerned about upholding economic activity, but production is not affected by how quickly the disease is spreading. in more realistic scenarios where the social planner attaches a positive weight on economic activity and it is more harmful for the economy to be locked down for longer than shorter time periods (e.g., because social distancing policies are more harmful for the economy the longer time they are enforced), the optimal policy is to (weakly) exceed health care capacity during the some time of the epidemic. our model is deliberately kept stylized and abstracts from several relevant considerations. the trade-off between economic activity and population health would arise also in more elaborate models, but the finding that it is optimal to (weakly) exceed health care capacity is more sensitive to modelling assumptions. there are several possible reasons why a slower spread of the disease (a flatter curve) below the health care capacity constraint may be optimal in a richer model. for example, if patients recover from the disease and develop immunity (as in a sir-model), a slower spread of the desease may limit the share of the population that is eventually infected. a slower spread may also be optimal if population health is negatively affected when more individuals are simultaneously infected also below the health care capacity constraint. finally, the possibility that a vaccine or better medical treatments becomes available provides additional incentives to delay the epidemic. although our model implies a sharp trade-off between output and population health, there are mechanisms that could mitigate that trade-off. in the context of our model, it would be beneficial to develop policies and technologies that can lower spread intensity while harming production less, perhaps using testing (e.g. berger et al., ) . another potential mechanism is that high disease transmission may reduce economic activity because people spontaneously limit consumption and reduce labor supply in fear of being infected also in the absence of a policy response (fenichel, ; atkeson, ; eichenbaum et al., ) . finally, because we do not explicitly incorporate mortality in our model, one apparent mechanism that dampens the tradeoff is that high mortality reduces population size and thereby production. however, we believe this latter channel to be of minor importance in the context of covid- due to relatively low mortality during productive years. our paper is a related to a number of recent papers, e.g., alvarez et al. ( ) , eichenbaum et al. ( ) , gollier ( ) and jones et al. ( ) , that combine the canonical epidemiological sir-model (kermack and mckendrick, ) with macroeconomic models to analyze how policymakers should optimally respond to a pandemic while taking both economic activity and population health into account. for example, eichenbaum et al. ( ) assumes that social distancing reduces consumption and labor supply, which limits spread of the disease and reduce economic activity. social distancing hence exacerbate the recession but raise welfare by reducing the number of pandemic-related deaths. eichenbaum et al. ( ) solve the model numerically and calibrate it to the covid- pandemic and find that it is optimal to introduce large-scale containment measures even if they result in a sharp (and sustained) output drop. several other papers using similar modelling approaches calibrated to the covid- pandemic also conclude that drastic front-loaded policies are optimal (alvarez et al., ; gonzalez-eiras and niepelt, ; jones et al., ) . our modelling approach is simpler which allows us to derive theoretical results without numerical calibration. in this respect, our model is more similar to earlier work in epidemiology starting with abakuks ( ) that study optimal disease control under resource constraints (see nowzari et al., , for a recent survey). another related paper in the domain of purely analytical results is behncke ( ) who shows existence of optimizers for a number of different policies. more recently, kruse and strack ( ) analyze optimal suppression when minimizing the total number of infected over time (i.e., a different objective function than in our model) subject to a cost of doing so, and morris et al. ( ) analyze how to minimize the peak of the infection curve when marginal cost of suppression is zero. the paper closest to ours is miclo et al. ( ) who focus on optimal suppression in order to not overwhelm health care capacity. they show that the optimal policy is time-varying. in contrast to them, the planner in our model is restricted to time-variant polices, but can exceed health care capacity at a cost. among the recent numerically-oriented papers favero et al. ( ) is the closest as they also take into account that harm increases substantially above health care capacity. an infection spreads in the population and a social planner must decide on a policy regarding the spread-intensity. the planner takes both production and population health into consideration and faces a trade-off: a higher spread-intensity implies that the economy needs to be locked down for a shorter period of time, but it imposes a higher stress on the health care system. to model this trade-off, we first introduce a simple infection model where a social planner can influence the spread-intensity through a single parameter. at any time t ≥ , x(t) ∈ ( , ) represents the share of the population that have been infected before time t. assume uniform pairwise random matching in the population, and that the infection spreads with probability p when an infected individual meets a susceptible individual (even if the infection occurred a long time ago). assume also that the time-rate of pairwise meetings is m > . in this simple infection model, there are only two types of individuals: susceptible and infected. in particular, there is no death or recovery from the infection, i.e., the infection model is what epidemiologists refer to as a si-model (see footnote ). a social planner can affect both p and m, e.g., by different containment policies, social distancing rules and various hygiene advice campaigns, but only at time t = . the spread-intensity parameter is given by a = pm. the mean-flow dynamic of the infection over time is then given by the following ordinary differential equation: with initial value x( ) ∈ ( , ). equation ( ) uniquely determines the dynamic evolution of the disease, and its solution is given by: where to the best of our knowledge the first time the logistic model was used to describe a population growth, as the one we have above, was by verhulst ( ) and further developed by the same author in verhulst ( ) . note that e ab = x( ) − . this way of writing the constant in the ode simplifies later arguments. from equation ( ), it follows that: x(t) = ae at (e ab + e at ) − ae at e at (e ab + e at ) = ae ab e at (e ab + e at ) . note thatẋ(t) : r → r + is a probability density function that describes the infection wave (in this case, a hump-shaped function, see the dashed-dotted lines in figure ) , and its integral x(t) : r → [ , ] a cumulative density function. consequently, for a given spread-intensity parameter a, the "size" of the infection wave at time t is given byẋ(t), and the "peak" of the wave occurs at the timet whereẍ(t) = . it can be verified thatt = b where b is given by equation ( ) for any value of a. because the value of b is proportional to /a, the greater a is the smallert = b is. a high spread-intensity rate therefore yields an early peak of the infectious disease. a social planner determines the optimal spread-intensity of the pandemic by taking both economic activities and population health into consideration. to spell out this trade-off formally we introduce a production function y and a health function h as a measure of how the economic activity and the health is affected by the pandemic, respectively. we begin by specifying the production function y(t | b). similar to for example eichenbaum et al. ( ) , we consider a problem in the short run (see also footnote ), so capital is fixed and we thus only need to consider labor when specifying the production function. in particular, it is assumed that production at time t depends on the share of non-infected individuals (i.e., the available labor force at time t) together with a continuous and differentiable function g : [b, t ] → r + . the idea is that g controls how production is affected by the "length" of the period until the pandemic hits its peak at b. it is assumed that g(b) ≥ and g (b) ≥ for all b ≥ b. these assumptions on g captures that the further away in time the peak of the pandemic is, the more harmful it is for production. the following reverse hump-shaped production function (see the dashed lines in figure ) describes this relation between the peak of the pandemic and the output produced in the economy to ensure that y(t | b) ≥ , it is also assumed that from the production function ( ) it follows that in the normal state of the economy, the entire population is working and produces an output equal to (this is only a normalization, any positive number instead of is fine). when the share of the population that has been infected approaches , the production again approaches the normalized output of . in all other time periods t, the production level depends both on the share of infected individualsẋ(t) and the function g(b) as specified in equation ( ). let us now look at the health function h(t | b) that determines the impact on health from the pandemic. we assume that there is a fixed capacity in the health care system, denoted by c ∈ [ , ], so if the peak is "too high," not all infected individuals can get proper health care at all times t. in fact, it can be shown that if a > c, then the health care capacity is (weakly) exceeded in the time interval [t l , t r ] where (see also the left panel of figure ): from these conditions and equation ( ), it follows that the "height" of the peak is exactly equal to the health care capacity at timet = b * , i.e.,ẋ(b * ) = c, when: for a < c, the capacity constraint c is never binding and all infected patients can receive treatment. infected individuals need medical treatment at the time t when they are infected but not before or after. from the social planner's perspective, this means that the health measure h(t | b) in period t is given by the share of the population that has not yet been infected, or has been infected before time t, or are infected at time t but receives proper health care: note also that t l and t r are functions of b. having specified how the economy and the health in the society is affected by the pandemic we can now write down the welfare in the society at time t as: where y(t | b) is the production function, h(t | b) is the health function, and λ ∈ [ , ] is a welfare weight reflecting the importance attached to production and health. the total welfare during the pandemic is obtained by integrating the welfare measure from time up to some given time t , the (short-run) objective for the planner is to select a spread-intensity that maximizes welfare. for convenience, we shall describe the planner's problem in terms of deciding on the timet where the infection wave peaks. note also that one can equivalently consider the problem of selecting the optimal spread-intensity parameter a since the exact relationship between a and b is given by equation ( ). as it is likely that it is practically difficult for the social planner to spread the disease "very fast," we shall assume that the peak cannot occur before some point in time b > . we are, however, agnostic about how close in time b is to t = . the planner's objective to maximize the social welfare function ( ) can be written as thus, for a given welfare weight λ ∈ [ , ], the objective for the social planner is to decide on the time where the infection wave peaks to maximize the social welfare given by ( ). the first result concerns the two extreme cases where the social planner puts all weight on either production or health. proposition . suppose that b ≥ b and g (b) > for all b ≥ b. if (i) λ = , then any b ≥ b * maximizes the welfare function ( ), and if (ii) λ = , then b = b maximizes the welfare function ( ). the first part of the proposition states that if the social planner only is concerned about health, the optimal policy is to never exceed the health care capacity at any time. the second part of the proposition states that if the social planner only is concerned about production, the optimal policy is to make the infection wave peak as soon as it is feasible. we next state another special case, namely the case when g (b) = for all b ≥ b, i.e., when production is equally affected independently of the spread-intensity and when in time the pandemic peaks. in this case, the optimal policy is again to never exceed the health care capacity at any time. proposition . suppose that λ ∈ [ , ], and that g (b) = for all b ≥ b. then b ≥ b * maximizes the welfare function ( ). the above two propositions states that if the social planner only values health or if the economy is equally affected independently of when the infection wave peaks, the optimal policy is to never exceed health care capacity. however, the assumption that g (b) = is rather unrealistic since this means that it is not more harmful for the economy to be locked down for longer than shorter time periods and that the social planner cannot affect the function g by any policy measures. if these assumptions are dropped and if, in addition, the planner attaches a positive weight on production, proposition and example show that the optimal policy is to (weakly) exceed health care capacity. proposition . let λ ∈ ( , ), and suppose that g (b) > for all b ≥ b. if b maximizes the social welfare function ( ), then it cannot be the case that b > b * . example . suppose that x( ) = . , t = , b = . , and c = . . if g(b) = + b t for all b ≥ b and λ = . , the welfare maximizing peak of the infection wave occurs at b = . implying that the health care capacity is exceeded in the interval [ . , . ] . this is illustrated in the left panel of figure where the infection waves (dashed-dotted lines) are illustrated in the bottom of the figure, and the production functions (dashed lines) and the health functions (solid lines) are illustrated in the top of the figure for different values of b between . and . . the corresponding functions for the optimal b = . are marked in red color. the right panel of figure , illustrates the situation for λ = . . in this case, the welfare maximizing policy is to set the peak of the infection wave at b = . , i.e., at the time where the "height" of the infection wave equals the health care capacity (c = . ). finally, we note that the if the social planner increases the welfare weight λ or health care capacity c, the optimal value of b weakly decreases. thus, if the social planner attaches more weight on production or if health care capacity increases, the optimal policy is to select an infection peak closer in time. figure : in the left panel, the health care capacity is exceeded at the welfare maximizing solution (b = . ). in the right panel, the "height" of the infection wave at the welfare maximizing solution (b = . ) equals health care capacity ( . ). because all proofs are based on the same ideas, we start by stating some general remarks that will be useful in all of the proofs. note first that t r > b > t l > b for all b ∈ (b, b * ) since capacity c is exceeded for all b ∈ [b, b * ), and t l = t r = b > b for b = b * since the "height" of the peak equals c for b = b * . hence, the welfare function ( ) is for any b ∈ [b, b * ] given by: note also that if b ∈ [b, b * ], it follows that: with strict inequality for b ∈ [b, b * ). finally, if b > b * the capacity c is never exceeded so the welfare function ( ) can be simplified to: proof of proposition . consider first part (i), and suppose that b ∈ [b, b * ]. by the above conclusions, it follows that furthermore, since λ = the welfare function ( ) can be written as: from equation ( ), it follows that w (b) < t for any b ∈ [b, b * ) and w (b) = t for b = b * . if, on the other hand, b > b * and λ = , the capacity is never exceeded so w (b) = t by equation ( ). this proves part (i) of the proposition. to prove part (ii), note that since λ = , the welfare function ( ) reduces to: since g(b) ≥ and g (b) > for all b ≥ b, and x(t ) − x( ) > , it follows that equation ( ) is maximized when b is minimized. hence, b = b maximizes equation ( ). proof of proposition . consider first the case when b ∈ [b, b * ]. because g(b) = and g (b) = for all b ≥ b by assumption, equation ( ) reduces to: w (b) = t − λ(x(t ) − x( )) + ( − λ)(c(t r − t l ) − (x(t r ) − x(t l ))). because t − λ(x(t ) − x( )) is a constant, equation ( ) is, by condition ( ), maximized when b = b * , i.e., when w (b * ) = t − λ(x(t ) − x( )). to complete the proof, we need only to demonstrate that the welfare equals t − λ(x(t ) − x( )) for any b > b * . but if b > b * , the capacity is never exceeded so the welfare function is given by equation ( ) for g(b) = and g (b) = , i.e., w (b) = t − λ(x(t ) − x( )) for all b > b * , which concludes the proof. proof of proposition . consider first the case when b ∈ [b, b * ]. then the welfare function is given by equation ( ), for b ≥ b * , this equation reduces to w (b) = t − λg(b)(x(t ) − x( )). because x(t ) − x( ) is a constant, g(b) ≥ and g (b) > for all b ≥ b, it then follows that w (b * ) > w (b) for any b > b * . hence, the welfare cannot be maximized for any b > b * . an optimal isolation policy for an epidemic a simple planning problem for covid- lockdown lockdowns and gdp. is there a tradeoff? working paper optimal control of deterministic epidemics an seir infectious disease model with testing and conditional quarantine the macroeconomics of epidemics economic considerations for social distancing and behavioral based policies during an epidemic impact of non-pharmaceutical interventions (npis) to reduce covid mortality and healthcare demand economic effects of coronavirus outbreak (covid- ) on the world economy cost-benefit analysis of deconfinement strategies on the optimal âȂijlockdownâȂİ during an epidemic? working paper does social distancing matter? working paper optimal control of epidemics with limited resources optimal mitigation policies in a pandemic: social distancing and working from home contributions to the mathematical theory of epidemics, part i optimal control of an epidemic through social distancing optimal epidemic suppression under an icu constraint optimal, near-optimal, and robust epidemic control analysis and control of epidemics: a survey of spreading processes on complex networks notice sur la loi que la population suit dans son accroissement. correspondence mathématique et physique recherches mathématiques sur la loi d'accroissement de la population key: cord- -tijcxtwx authors: wang, chen; horby, peter w; hayden, frederick g; gao, george f title: a novel coronavirus outbreak of global health concern date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: tijcxtwx nan a novel coronavirus outbreak of global health concern by genetic sequencing as a novel coronavirus. risk assessment at that time was guarded but suggested that the outbreak was more like that caused by the middle east respiratory syndrome (mers) coronavirus than the severe acute respiratory syndrome (sars) coronavirus. however, this information was from what now appears to be first-generation cases from a point source, but at the time it seems that a second generation, and perhaps a third generation, of cases was already reported in the incubation period, and this generation appears to have included health workers. health worker infections are an ominous finding in any emerging infection. front-line health workers can be initially at risk and infected when they examine and treat patients who present with a respiratory infection; if handwashing or other infection prevention and control measures are not in place, these health workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases and treatments, family members, and the community. early in the sars coronavirus outbreak, frontline health workers became infected, which amplified transmission to patients in hospitals where outbreaks were occurring. early evidence from the initial mers outbreaks suggested that health workers were likewise being infected, but that their infections were less severe than those of patients in hospitals who became infected and had comorbidities such as diabetes or chronic respiratory disease. today, the epidemiology of both sars and mers viruses is mostly understood, and the same will be true for the current outbreak of -ncov if data continue to be freely shared and used to provide realtime guidance. these articles and others being rapidly disseminated and shared will have a major role in assuring that this global collaboration occurs. jan , , a total of cases with laboratoryconfirmed -ncov infection have been detected in china, of whom have died and % remain in hospital (figure). in the lancet, chaolin huang and colleagues report clinical features of the first patients admitted to the designated hospital in wuhan who were confirmed to be infected with -ncov by jan , . the study findings provide first-hand data about severity of the emerging -ncov infection. symptoms resulting from -ncov infection at the prodromal phase, including fever, dry cough, and malaise, are nonspecific. unlike human coronavirus infections, upper respiratory symptoms are notably infrequent. intestinal presentations observed with sars also appear to be uncommon, although two of six cases reported by chan and colleagues had diarrhoea. common laboratory findings on admission to hospital include lymphopenia and bilateral ground-glass opacity or consolidation in chest ct scans. these clinical presentations confounded early detection of infected cases, especially against a background of ongoing influenza and circulation of other respiratory viruses. exposure history to the huanan seafood wholesale market served as an important clue at the early stage, yet its value has decreased as more secondary and tertiary cases have appeared. of the patients in this cohort, ( %) developed severe dyspnoea and ( %) required admission to an intensive care unit, and six died. hence, the case-fatality proportion in this cohort is approximately · %, and the overall case fatality proportion appears to be closer to % (table) . however, both of these estimates should be treated with great caution because not all patients have concluded their illness (ie, recovered or died) and the true number of infections and full disease spectrum are unknown. importantly, in emerging viral infection outbreaks the case-fatality ratio is often overestimated in the early stages because case detection is highly biased towards the more severe cases. as further data on the spectrum of mild or asymptomatic infection becomes available, one case of which was documented by chan and colleagues, the case-fatality ratio is likely to decrease. nevertheless, the influenza pandemic is estimated to have had a case-fatality ratio of less than % but had an enormous impact due to wide spread transmission, so there is no room for complacency. as an rna virus, -ncov still has the inherent feature of a high mutation rate, although like other coronaviruses the mutation rate might be somewhat lower than other rna viruses because of its genomeencoded exonuclease. this aspect provides the possibility for this newly introduced zoonotic viral pathogen to adapt to become more efficiently transmitted from person to person and possibly become more virulent. infecting at least people and causing deaths. the international spread of sars-cov in was attributed to its strong transmission ability under specific circumstances and the insufficient preparedness and implementation of infection control practices. chinese public health and scientific capabilities have been greatly transformed since . an efficient system is ready for monitoring and responding to infectious disease outbreaks and the -ncov pneumonia has been quickly added to the notifiable communicable disease list and given the highest priority by chinese health authorities. the increasing number of cases and widening geographical spread of the disease raise grave concerns about the future trajectory of the outbreak, especially with the chinese lunar new year quickly approaching. under normal circumstances, an estimated billion trips would be made in the spring festival travel rush this year, with million trips happening in wuhan. the virus might further spread to other places during this festival period and cause epidemics, especially if it has acquired the ability to efficiently transmit from person to person. consequently, the -ncov outbreak has led to implementation of extraordinary public health measures to reduce further spread of the virus within china and elsewhere. although who has not recommended any international travelling restrictions so far, the local government in wuhan announced on jan , , the suspension of public transportation, with closure of airports, railway stations, and highways in the city, to prevent further disease transmission. further efforts in travel restriction might follow. active surveillance for new cases and close monitoring of their contacts are being implemented. to improve detection efficiency, front-line clinics, apart from local centres for disease control and prevention, should be armed with validated point-of-care diagnostic kits. rapid information disclosure is a top priority for disease control and prevention. a daily press release system has been established in china to ensure effective and efficient disclosure of epidemic information. education campaigns should be launched to promote precautions for travellers, including frequent hand-washing, cough etiquette, and use of personal protection equipment (eg, masks) when visiting public places. also, the general public should be motivated to report fever and other risk factors for coronavirus infection, including travel history to affected area and close contacts with confirmed or suspected cases. considering that substantial numbers of patients with sars and mers were infected in health-care settings, precautions need to be taken to prevent nosocomial spread of the virus. unfortunately, health-care workers, some of whom were working in the same ward, have been confirmed to be infected with -ncov to date, although the routes of transmission and the possible role of so-called superspreaders remain to be clarified. epidemiological studies need to be done to assess risk factors for infection in health-care personnel and quantify potential subclinical or asymptomatic infections. notably, the transmission of sars-cov was eventually halted by public health measures including elimination of nosocomial infections. we need to be wary of the current outbreak turning into a sustained epidemic or even a pandemic. the availability of the virus' genetic sequence and initial data on the epidemiology and clinical consequences of the -ncov infections are only the first steps to understanding the threat posed by this pathogen. many important questions remain unanswered, including its origin, extent, and duration of transmission in humans, ability to infect other animal hosts, and the spectrum and pathogenesis of human infections. characterising viral isolates from successive generations of human infections will be key to updating diagnostics and assessing viral evolution. beyond supportive care, no specific coronavirus antivirals or vaccines of proven efficacy in humans exist, although clinical trials of both are ongoing for mers-cov and one controlled trial of ritonavir-boosted lopinavir monotherapy has been launched for -ncov (chictr ). future animal model and clinical studies should focus on assessing the effectiveness and safety of promising antiviral drugs, monoclonal and polyclonal neutralising anti body products, and therapeutics directed against immunopathologic host responses. we have to be aware of the challenge and concerns brought by -ncov to our community. every effort should be given to understand and control the disease, and the time to act is now. fgh reports personal fees from university of alabama antiviral drug discovery and development consortium, and is a non-compensated consultant for gilead sciences, regeneron, and sab biotherapeutics, which have investigational therapeutics for coronavirus infections. all other authors declare no competing interests. the novel coronavirus ( -ncov) outbreak is a major challenge for clinicians. the clinical course of patients remains to be fully characterised, little data are available that describe the disease pathogenesis, and no pharmacological therapies of proven efficacy yet exist. corticosteroids were widely used during the outbreaks of severe acute respiratory syndrome (sars)-cov and middle east respiratory syndrome (mers)-cov, and are being used in patients with -ncov in addition to other therapeutics. however, current interim guidance from who on clinical management of severe acute respiratory infection when novel coronavirus ( -ncov) infection is suspected (released jan , ) advises against the use of corticosteroids unless indicated for clinical evidence does not support corticosteroid treatment for -ncov lung injury geneva: world health organization geneva: world health organization beijing: china national health commission geneva: world health organization first travel-related case of novel coronavirus detected in united states a familial cluster of pneumonia associated with the novel coronavirus indicating person-to-person transmission: a study of a family cluster clinical features of patients infected with novel coronavirus in wuhan, china the epidemiology of severe acute respiratory syndrome in the hong kong epidemic: an analysis of all patients geneva: world health organization middle east respiratory syndrome coronavirus (mers-cov). geneva: world health organization epidemiological, demographic, and clinical characteristics of cases of middle east respiratory syndrome coronavirus disease from saudi arabia: a descriptive study who. summary of probable sars cases with onset of illness from age-and sex-specific mortality associated with the - influenza pandemic in kentucky epidemiology and cause of severe acute respiratory syndrome (sars) in guangdong, people's republic of china emergency committee regarding the outbreak of novel coronavirus ( -ncov). geneva, world health organization beijing: china national health commission clinical management of severe acute respiratory infection when novel coronavirus (ncov) infection is suspected. geneva, world health organization key: cord- -giijfhbz authors: khubone, thokozani; tlou, boikhutso; mashamba-thompson, tivani phosa title: electronic health information systems to improve disease diagnosis and management at point-of-care in low and middle income countries: a narrative review date: - - journal: diagnostics (basel) doi: . /diagnostics sha: doc_id: cord_uid: giijfhbz the purpose of an electronic health information system (ehis) is to support health care workers in providing health care services to an individual client and to enable data exchange among service providers. the demand to explore the use of ehis for diagnosis and management of communicable and non-communicable diseases has increased dramatically due to the volume of patient data and the need to retain patients in care. in addition, the advent of coronavirus disease (covid- ) pandemic in high disease burdened low and middle income countries (lmics) has increased the need for robust ehis to enable efficient surveillance of the pandemic. ehis has potential to enable efficient delivery of disease diagnostics services at point-of-care (poc) and reduce medical errors. this review provides an overview of literature on ehis’s with a focus on describing the key components of ehis and presenting evidence on enablers and barriers to implementation of ehiss in lmics. with guidance from the presented evidence, we proposed ehis key stakeholders’ roles and responsibilities to ensure efficient utility of ehis for disease diagnosis and management at poc in lmics. the health sector is lagging behind in the era of information and technology (it). the main purpose for use of it in the health sector include the following: extending geographic access to health care; enhancing client communication with the health provider; improving disease diagnosis and treatment; improved data quality management; and to avoid fraud and abuse of client's confidentiality [ ] [ ] [ ] . the introduction of digitization has revealed the possibilities and costs benefits to health care management. it systems such as electronic health information systems (ehis) have been shown to be a useful tool for improving disease diagnosis and treatment at point of care (poc), globally [ ] [ ] [ ] . ehis is the digital version of a patients' paper chart, which has capacity to store health data such as test results and treatments. it is also designed to enable real-time, patient-centered records that make information available instantly and securely to the authorized users [ ] . the term ehis is used interchangeably with electronic health records (ehrs), ehealth and electronic medical records (emrs). ehis are a vital part of health it built to go beyond standard clinical data collected in a providers' office and can be inclusive of a broader view of a patient care [ ] . an efficient functioning ehis requires the use of digital health systems such as three interlinked electronic register (tier.net), which has an ability to facilitate information exchange between software [ ] . tier.net is used by healthcare facilities to enable electronic collection, storage, management and sharing records (emrs). ehis are a vital part of health it built to go beyond standard clinical data collected in a providers' office and can be inclusive of a broader view of a patient care [ ] . an efficient functioning ehis requires the use of digital health systems such as three interlinked electronic register (tier.net), which has an ability to facilitate information exchange between software [ ] . tier.net is used by healthcare facilities to enable electronic collection, storage, management and sharing of patient's electronic health or medical records for the purpose of patient care, research and quality management [ ] . countries are currently battling with a global pandemic caused by the outbreak of sars cov- , a virus that causes coronavirus disease . the advent of covid- in high disease burdened low and middle income countries (lmics) such as south africa has increased the need for robust ehis to enable efficient surveillance of the pandemic [ ] . the main objective of this review is to presents an overview of literature on the characteristics of ehis and implementation of ehiss for improving disease diagnosis and treatment at point-of-care in the lmics. we search for literature from the following databases: pubmed and google scholar and included relevant literature from lmics. an efficiently functioning ehis is key to health service delivery as it promises a number of substantial benefits, including improving the quality of healthcare service delivery, decreased healthcare costs as well as reduce serious unintended consequences [ ] . a poorly implemented ehr system can lead to ehr-related errors that jeopardize the integrity of the information in the ehr, leading to errors that endanger patient safety as well as compromise the quality healthcare services [ ] . the following key components are required for an efficient functioning ehis: patient management component; activity component; clinical component; pharmacy component; laboratory component; radiology information system; and billing system ( figure ) [ ] . table provides a description on the functions of ehr components within the electronic health system and patient care. patient registration includes key patient information such as demographics, insurance information and contact information [ ] populations and their needs are analyzed at a point of care to determine the services to be rendered to them [ ] activity ehis flow processed from when a client is entering the point of service till data is digitized on the system [ , ] traceability of health data habitation of multiple sub-components, e.g., computerized provide order entry (cpoe), electronic documentation, nursing component [ ] electronic clinical documentation systems enhance the value of ehrs by providing electronic capture of clinical notes; patient assessments; and clinical reports, such as medication administration records (mar) [ ] pharmacy ehis islands of automation, such as pharmacy robots for filling prescriptions or payer formularies, that typically are not integrated with ehrs [ ] improve efficiency of pharmacy services consists of two subcomponents: capturing results from lab machines; and integration with orders, billing and lab machines. the lab component may either be integrated with the ehr or exist as a standalone product [ , ] improve efficiency of pathology laboratory services manages patient workflow, ordering process and results [ ] enables improved service delivery the billing system (hospital and professional billing) captures all charges generated in the process of taking care of patients. these charges generate claims, which are subsequently submitted to insurance companies, tracked and completed [ ] tracking of patient data and quality assurance evidence on ehis in developing countries revealed the following ehealth attributes: tracking of patients who were initiated on treatment; monitoring of adherence to care and early detection of potential loss to follow up; minimize the time it takes to communicate data between different levels; reduction of errors especially the laboratory data; linkage to bar code for unique identification and laboratory samples and the prescription of medication [ ] . in mozambique, a robust electronic patient management system facilitated a facility-level reporting of required indicators, improved ability to identify patients lost to follow-up; and support facility and patient management for hiv care [ ] . an implementation study aimed at implementing an integrated pharmaceutical management information system for antiretroviral treatment (art) and other medicines in namibia showed the system's reliability in managing art patients, monitoring art adherence and hiv drug resistance early warning indicators [ ] . enables of ehis implementation in the lmics are aligned with leadership abilities, sound policy decision and financial support with the goals of purchasing it, connectivity and capacity building [ ] . enablers for ehis in lmics includes: legislation, financial investment; staff training, political leadership; acceptability of technology; performance expectancy; and social influence among professionals [ ] [ ] [ ] . many lmics are supporting financial investment to help scaling up of ehis. a study from china recommended that in order to achieve the national childhood immunization information management system objectives for , the funding for system-building should be increased [ ] . a three-country qualitative study was conducted in southern africa on the sustainability of health information systems which revealed; more government commitment in funding ehis such as printer ink, it infrastructure, recruitment of personnel and running costs [ ] . in ghana, cooperation between the vendors and management was demonstrated [ ] . this successful cooperation translated into regularly provision of feedback and sucessful system maintenance [ ] . this has helped the facility in alleviating the common challenge faced by most information communication and technology (ict) implementers in limcs [ ] . south africa national health act of is a good example of a legislation, policy, norms and standards defining the role of national, provincial and local governments in terms of ehis implementation in lmics [ ] . south africa has advocated the scale up of digital health technologies to improve access to health care and for health systems strengtherning through systems such as tier.net and district health information software (dhis and patient registration systems [ ] . the delivery of ehis or ehealth in south africa's public sector facilities is the responsibility of the provincial departments of health, while policy development resides with the national department of health (ndoh). in terms of section of the national health act, the ndoh is also responsible for facilitation and coordination of health information. there is growing evidence on the value of well-trained health informatics workforce in lmics [ ] . studies conducted in botswana and uganda showed the on-the-job training and mentorship as a major enabler for ehis in lmics [ , ] . this were shown to be an effective approach for strengthening monitoring and evaluation capacity and ensuring data quality within a national health system [ ] . it was demonstrated that on-the-job training can also improves performance through timely and increased reporting of key health indicators [ ] . effective leadership can positively contribute to the successful adoption of new ehis in any organization [ ] . in ethiopia, the role of ict towards universal health coverage prompted academic and political spheres to make ict on the agenda especially for disease diagnosis and treatment in the lmics [ ] . the rwandan government has also shown commitment to telemedicine, through their strategic choice of using low-cost and less complex technologies, and strategic partnerships with educational and technology companies to help in the implementation of telemedicine [ ] . research has shown that factors such as english language proficiency level, computer literacy and emr literacy level and education level can influence the level of use of ehis [ ] . liu and others revealed that the usage of ehis by health workers in lmics can be influenced by the level of system simplicity and user friendliness [ ] . an economical mobile health application to improve communication between healthcare workers was introduced in kwazulu-natal, south africa using an iterative design process [ ] . this application was received positive feedback from healthcare workers due to its ability to improve team spirit between community and clinic based staff [ ] . there are various factors impeding the successful implementation and scale up of ehis in lmics. these include the following: complexity of the intervention and lack of technical consensus; limited human resource, poor leadership, insufficient finances, staff resistance, lack of management, low organizational capability; misapplication of proven diffusion techniques; non engagement of both local users and inadequate use of research findings when implementing [ ] . the complexity of the ehis which and lack of consultation as key barriers on the implementation in lmics [ ] . designing an organizational ehis with a complex design is a serious threat of the implementation in lmics [ ] . in rwanda, the interfaces between the existing and new ehis are the inhibitors to the implementation [ ] . there are instances of patient information that are captured into the computer; but challenged with bandwidth requirements in health facilities [ ] . the main barriers in implementing ehis on the lmics relate to lack of capacity: human, leadership and management [ ] . human resource capacity is the main barrier not only in terms of the supply but also in terms of the ability to perform the task. the exodus of skilled cadres to the well-paying non-government organizations are the contributing factors to human resource capacity [ ] . ineffective coordination, poor management and lack of supervision for ehis are the main challenges in the lmics [ , ] . management capacity and the ability to use data were reported as the root causes in facilities with inadequate human resource, computers and data capturing skills [ ] . late submission of health data and absence of feedback from the supervisors are the key barriers to ehis implementation in lmics [ ] . ehis implementation is costly as there is hardware, software, maintenance, training and human resource investment making implementation unaffordable to many lmics [ ] . cost is the main constraint to adoption and implementation of ehis in lmics [ ] . running costs and political will are the prerequisite for sustaining ehis [ ] . unreliable electricity supply, shortage of it equipment, poor connectivity and safe accommodation for the equipment are the restraining elements to the successful implementation of ehis [ ] . poor public healthcare system with ever changing policies are a hindrances to the successful implementation of the ehis in lmics [ ] . leon and others used a framework for assessing the health system challenges to scaling up m-health in south africa and revealed a weak ict environment and limited implementation capacity within the health system [ ] . katuu explored the barriers in improving south african public health sector through ehealth strategy particularly by integrating electronic document and records management system. inequality, historical red tape and curative structure are the main barriers [ ] . in asia, incapacitated human resources and shortage of it skills were identified as inhibiting factors to ehis implementation [ ] . in iran, lack of users' knowledge about system and working with it were the barriers identified [ ] . in most of the lmics; the need for a trained workforce in health informatics is great [ ] . there are instances where computer illiterate and low morale to use the system are affecting the implementation [ , ] . some of the challenges include related to ehis software, cost drivers, interoperability, connectivity in rural set up and data quality [ ] . a study conducted in south africa, demonstrated difficulties with implementing a dual ehis as a result of clinicians' resistance to using the ehis and feel more comfortable using paper based system [ ] . in iran, the negative staff attitudes of system developers and lack of acceptability are the main barriers to successful implementation of hospital-based ehis [ ] . although south africa ehis catered for all required information, the hospital officials show poor due to the attitude and resistance to using ehis for patient treatment and prescriptions [ ] . an assessment was conducted by khasi ehis state of readiness for rural south african areas, which revealed that the resistance to change and negative perceptions were two key causes for not accepting the intervention. any new ehis intervention must address them in order to succeed [ ]. studies revealed incompleteness of tb data across multiple information systems in south africa. variances between % and % of the missed cases due to poor recording from the source documents (either patient records or laboratory records) were demonstrated [ , ] . data collected and reported in the public health system across three large, high hiv-prevalence districts was neither complete nor accurate enough to guide patient tracking as part of prevention of mother to child transmission (pmtct) care [ ] . this review has provided us with a great platform to depict opportunities of ehis implementation in lmics. it has also enabled us to identify and classify barriers and challenges implementation of ehis that must be addressed pre-implementation to ensure the success. key to the success of ehis is the leader's willingness to play a leading role in adopting data demand and supply principles for decision making. the presented literature reveals the need for well-defined roles of ehis stakeholders to ensure successful implementation and utility. here, we proposed key stakeholders roles and responsibilities in the implementation of ehis for disease diagnosis and management at point-of-care (poc) in lmics ( figure ). in the proposed key stakeholders' roles and responsibilities we emphesise on that the information culture should be cascaded through different hierarchy levels of an organization. in the absence of the such culture there is likely to be poor adoption, poor data quality and utilization [ ] . the advent of ehis has revolutionize patient care through improving both disease diagnosis and treatment at poc. however, its use in lmics is still limited, despite the high disease burden in these settings. ehis implementation need to be one of the global health priorities to help respond to community's health needs, particularly during the current covid- pandemic. successful implementation of ehis requires commitment from health leaders to play a strategic role in terms of the advent of ehis has revolutionize patient care through improving both disease diagnosis and treatment at poc. however, its use in lmics is still limited, despite the high disease burden in these settings. ehis implementation need to be one of the global health priorities to help respond to community's health needs, particularly during the current covid- pandemic. successful implementation of ehis requires commitment from health leaders to play a strategic role in terms of the policy directive, resource mobilization and evidence-based decision-making. to help optimize the implementation and use of ehis in lmics, we have proposed roles and responsibilities of stakeholders to ensure efficient and 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major public health event, threatening people's physical and mental health and even life safety. this study is to investigate the psychological abnormality in health care workers battling the covid- epidemic and to explore the associations among social support, resilience and mental health. a total of health care workers, of whom had public health emergency experience while showed no experience, completed the symptom check-list- (scl- ), chinese version of connor-davidson resilience scale (cd-risc) and social support rating scale (ssrs). χ( ) test, t test and multiple regression analyses were used in statistical analysis. the results showed that people without public health emergency treatment experience showed worse performance in mental health, resilience and social support, and tended to suffer from psychological abnormality on interpersonal sensitivity and photic anxiety. this finding suggested that high levels of training and professional experience, resilience and social support were necessary to health care workers who are first taking part in public health emergence. corona virus disease originated in wuhan has spread throughout china from december , which has seriously threatened human health (huang et al., ) . on th january, who announced the novel coronavirus pneumonia (ncp, later renamed as covid- ) epidemic as public health emergency of international concern (who, ) . according to the statistics of the national health commission of the people's republic of china, , confirmed cases, , suspected cases and deaths had been reported in chinese mainland up to : on march (nhcprc, ) . the outbreak of covid- as a major health care event has exerted a negative impact on daily life, threatened people's health both mentally and physically, and endangered social and economic development (ma et al., ) . in the face of such a severe situation, the government and the health department have issued various prevention and control policies, and actively taken various prevention and control measures to contain the epidemic. since covid- is the largest public health emergency in china in the past ten years, many young health care workers take active part in battling the covid- epidemic. different from the experienced ones who have ever joined the public health emergency such as sars, h n , the fresh health care workers at around years old are confronted with the much more occupational stress, which is also a big challenge to their resilience and mental health. resilience is an individual's capacity to deal with significant adversity and quick recover (fletcher and sarkar, ) . previous study showed that psychological resilience can protect individuals against mental illness and thrive from the adversity (perlman et al., ; hu et al., a, b) . thus, it might help predict the workers' mental health by assessing their resilience. social support is individuals' perception or experience in terms of being involved in a social group where people mutually support each other (cao et al., ) . family, friends or any other important relatives could provide material and spiritual support, which probe to be positively associated with mental health (rothon et al., ) . due to highly contagious covid- , the health care workers have to cut off the direct contact with other people, and spend time alone after work. therefore, the availability of social support might be of importance to medical team. this research is to investigate the mental health among the health care workers battling the covid- and to explore the associations among social support, resilience and mental health. https://doi.org/ . /j.ajp. . received march ; received in revised form april ; accepted april a total of health care workers were recruited in this study. they all took part in battling the covid- epidemic in jiangsu province. among them, people had public health emergency experience before (experienced staff), while people had no experience (fresh staff). all participants completed the symptom check-list- (scl- ), chinese version of connor-davidson resilience scale (cd-risc) and social support rating scale (ssrs). the scl- , designed by derogatis and his colleagues (derogatis et al., ) , is a questionnaire to assess self-reported symptom intensity including a number of different subscales. the -item scale consists of factors including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, photic anxiety, paranoididefition, psychotieism, and additionalitems. responses to items are measured on a -point likert scale ranging from (none) to (severe). items are added and converted to obtain the subscale scores and total score. if any subscale score is higher than , positive items are higher than , or the total score is higher than , it suggests psychological abnormality. the scl- has been widely used in previous studies with high reliability and validity (crespo-maraver et al., ; holi et al., ; wei et al., ) . it exhibited strong internal consistency (cronbach's alpha = . ) in the current sample. we evaluated resilience using the cd-risc, which was first developed by connor and davidson (connor and davidson, ) , and was later revised into chinese version evolved by yu and her colleagues (yu et al., ) . the -item scale contain three conceptually distinct subscales: strength (e.g., coping with stress strengthens), tenacity (e.g., when things look hopeless, i don't give up) and optimism (e.g., see the humorous side of things). responses to items are measured on -point likert scale ranging from (not true at all) to (true nearly all the time). items are added to obtain scores between to , with higher scores denoting great resilience. the chinese version of cd-risc has shown good reliability and validity (cai et al., ) , and it also exhibited strong internal consistency (cronbach's alpha = . ) in the current sample. the ssrs, designed by xiao ( ) , is a multidimensional self-report scale assessing social support. the items comprise factors: objective support (e.g., what's the sources of financial support and help to solve practical problems when you were in an emergency situation), subjective support (e.g., how many close friends do you have to get support and help), and availability (e.g., how to ask for help in case of trouble). item scores are summed together to obtain the total score - with higher scores denoting stronger social support. the ssrs has been widely used in chinese populations showing high reliability and validity (liu et al., ) , and it exhibited strong internal consistency (cronbach's alpha = . ) in the current sample. this study was approved by the ethics committees of the second military medical university. all participants received an informed consent before data collection, so that they could choose whether or not to participate, and withdraw at any time if they wished. frequencies, percentages and standard deviations were calculated for descriptive analysis. demographic and occupation backgrounds of health care workers with and without psychological abnormality were compared using χ test. the differences of mental health, resilience and social support between fresh staff and experienced staff were compared via simple independent sample t-test and multiple regression analyses were used to examine the associations among resilience, social support and mental health in fresh staff and experienced staff. p＜ . was considered statistically significant. spss . (spss inc, chicago, il) was used to conduct the analysis. the prevalence of psychological abnormality was . %. as shown in table , public health emergency treatment experience was significantly associated with a decreased prevalence of psychological abnormality. besides, there was a marginal significant association between the length of service and the prevalence of psychological abnormality. to address the cohort effect of age, we further compare prevalence of psychological abnormality between fresh group and experienced group in the over- . fresh staff and experienced staff turned out to be positive. there was also a marginal significant association between public health emergency treatment experience and prevalence of psychological abnormality in over- populations (χ = . , p = . ). we further compared the mental health differences between experienced staff and fresh staff. as shown in table , statistically significant differences in interpersonal sensitivity and photic anxiety were noted between groups (p＜ . ). besides, there was a marginal significant difference in obsessive-compulsive (p＜ . ) and no significant differences in other seven subscales. table shows that fresh staff had significantly lower scores in cd-risc total and three subscales than experienced staff (p＜ . ). in compared with experienced staff, fresh staff has presented a significantly lower level of resilience, and the significance held across the three aspects: tenacity, strength, optimism. table shows that fresh staff had significantly less scores in objective support, subjective support and ssrs total scores than experienced staff (p＜ . ). nevertheless, there was no significant difference in availability of support between groups. table shows the result of multiple regression analysis predicting mental health by resilience and social support in fresh staff and experienced staff. tenacity, strength, objective support, subjective support and availability of support could significantly predict the mental health in fresh staff. however, there is no factors significantly predicting mental health in experienced staff. previous study showed that occurrence of psychiatric symptoms were linked to younger age and less family support (su et al., ) . the current study further revealed that people without public health emergency experience showed worse mental health, resilience and social support, and tended to get psychological abnormality on interpersonal sensitivity and photic anxiety. apart from working at the front line, they stayed at room alone without any face-to-face interpersonal communication. lack of social support leads to much more depression and anxiety especially in high-risk working conditions (plaisier et al., ) . in order to prevent cross infection, the social distance between people had to be increased. when others had fevers or cough, people became more sensitive and tended to show some obsessive-compulsive symptoms such as washing hands repeatedly. the daily increasing numbers of confirmed cases and deaths also increase the level of anxiety and terror in the fresh staff. nevertheless, majority of the experienced staff had taken part in previous public health emergence before, such as severe acute respiratory syndrome (sars) and h n . they knew how to protect themselves better and had the confidence to overcome the disease compared with fresh staff, which was of benefit to enhance their resilience and mental health. therefore, constructive peer-support (banerjee, ) , effective online mental health service (yao et al., ) and early screening and interventions (zandifar and badrfam, ) were necessary to address mental health needs in health care workers. another intriguing finding from our study is that resilience (tenacity, strength) and social support (objective support, subjective support and availability of support) could significantly predict the mental health in fresh staff. resilience is regarded as a protective factor to mental health (hu et al., a, b) . the fresh staff with high strength and tenacity showed greater courage and would not quit in this medical battle. certainly, good social support might also have buffered the average severity of symptom among people in high risk work (chen w. cai, et al. asian journal of psychiatry ( ) et al., dyregrov et al., ) . therefore, it is important to have a high level of training and professional experience in health care workers engaging in public health emergence, especially for the fresh staff. several limitations in current study need to be mentioned. one is that we lack of investigation on fatigue status and sleep quality of health care workers. the usual rhythm of work and life was disrupted, which might lead to their insomnia and fatigue. on the other hand, the cross-sectional design failed to explain it thoroughly whether the weak resilience and less social support in fresh staff caused their much more psychological abnormality. since the public health emergence has a long-term effect on health care workers' anxiety, depression and sleep quality (chen et al., ) , the following researches are suggested to adopt a within-design study to evaluate the mental health and potential factors of health care workers during the public health treatment. on the basis of our findings, health care workers without public health emergency experience showed worse performance in mental health, resilience and social support, and tended to get psychological abnormality on interpersonal sensitivity and photic anxiety. a high level of training and professional experience, resilience and social support were necessary for health care workers who are first taking part in public health emergence. none. no conflict of interest exits in the submission of this manuscript. the covid- outbreak: crucial role the psychiatrists can play relationship between cognitive emotion regulation, social support, resilience and acute stress responses in chinese soldiers: exploring multiple 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personality questionnaire (epq) international health regulations emergency committee on novel coronavirus in china social support rating scale. chin rethinking online mental health services in china during the covid- epidemic factor analysis and psychometric evaluation of the connor-davidson resilience scale (cd-risc) with chinese people iranian mental health during the covid- epidemic key: cord- -yzb yo authors: popovich, michael l.; watkins, todd; kudia, ousswa title: the power of consumer activism and the value of public health immunization registries in a pandemic: preparedness for emerging diseases and today’s outbreaks date: - - journal: online j public health inform doi: . /ojphi.v i . sha: doc_id: cord_uid: yzb yo public health immunization registries and the immunization ecosystem have evolved over the past two decades to become significant population health data assets. clinical providers and pharmacists are reporting the immunizations given to their patients to public health registries in states and all territories, creating consolidated immunization event patient records. most of these immunization events are reported through the provider’s electronic health record system (ehr), pharmacy management system (pms), online, or through data uploads. meaningful use and health data standards (hl ) became the drivers that accelerated reporting to immunization registries and significantly improved the quantity and quality of the data. the infrastructure supporting the immunization ecosystem (ie) has enabled real-time compliance reporting and, more importantly, real-time patient queries. the provider community now has online access to a patient’s immunization history in over three quarters of the states, and growing. this access includes a forecast of the patient’s immunization gaps provided by public health decision support tools based upon the most recent acip recommendations. this is creating an opportunity for the provider and the patient to work together to reduce their risk of suffering a vaccine-preventable disease. this ie and the data in an immunization information system (iis) are especially useful as pharmacies expand their immunization practices and create opportunities to reduce the adolescent and adult immunization gaps. in a few states, this provider-public health ecosystem has begun to extend to individuals by allowing them to access the iis online through the use of myir. myir provides them with the electronic version of their immunization "yellow cards," recommendations for immunizations due, and the ability to print official certificates. this emerging consumer engagement creates opportunities to empower individuals to be more proactive in their family’s health care. this paper builds upon early experiments to empower individuals in this ecosystem by leveraging the value of these public health data assets and trusted communications, illustrating the possibilities for engaging consumers to support reducing the impact of emerging diseases, outbreaks and the next pandemic. this paper will suggest the value of the ie and the role individuals can play within their own social networks to advance public health efforts to manage disease events. in turn, this social mission would encourage consumers to be more proactive in managing their own healthcare. most of these immunization events are reported through the provider's electronic health record system (ehr), pharmacy management system (pms), online, or through data uploads. meaningful use and health data standards (hl ) became the drivers that accelerated reporting to immunization registries and significantly improved the quantity and quality of the data. the infrastructure supporting the immunization ecosystem (ie) has enabled real-time compliance reporting and, more importantly, realtime patient queries. the provider community now has online access to a patient's immunization history in over three quarters of the states, and growing. this access includes a forecast of the patient's immunization gaps provided by public health decision support tools based upon the most recent acip recommendations. this is creating an opportunity for the provider and the patient to work together to reduce their risk of suffering a vaccine-preventable disease. this ie and the data in an immunization information system (iis) are especially useful as pharmacies expand their immunization practices and create opportunities to reduce the adolescent and adult immunization gaps. in a few states, this provider-public health ecosystem has begun to extend to individuals by allowing them to access the iis online through the use of myir. myir provides them with the electronic version of their immunization "yellow cards," recommendations for immunizations due, and the ability to print official certificates. this emerging consumer engagement creates opportunities to empower individuals to be more proactive in their family's health care. when asked what scared him the most and kept him up at night, tom frieden, the former director of the cdc, replied: "the biggest concern is always for an influenza pandemic." [ ] a recent cnn article [ ] outlined the world health organization's (who) review of potential public health emergency diseases that included the top global concerns: crimean-congo haemorrhagic fever (cchf), ebola virus disease and marburg virus disease, lassa fever, middle east respiratory syndrome coronavirus (mers-cov) and severe acute respiratory syndrome (sars), nipah and henipaviral diseases, rift valley fever (rvf), zika, and finally disease x. currently there are no vaccines to prevent these. the who's disease x was included in this "list of blueprint priority diseases" [ ] because the world does not know what pathogen can cause the next epidemic. globally, as well as in the u.s., epidemiologists and public health professionals work endlessly to ensure the risk and impact of existing and emerging diseases are minimized, and that neither turns into a pandemic. as the world increasingly becomes interconnected through travel and technology, timely information and accurate data become more imperative. early warning of disease occurrence and assessing the resulting impact on the public are paramount. early warning systems referred to as "syndromic surveillance," along with mandated notifiable disease reporting, capture data and electronically process the information to present public health with a view into future potential impacts. over the past two decades, new information systems have played a key role in improving public health's early warning and case management for disease outbreaks. as improved analytics are used to predict risk in populations, researchers and epidemiologists open new doors to disease cures, clinical research develops new medicines, and providers develop new care models. the role of technology and public health to support these efforts therefore becomes more valuable. health information systems are traditionally considered to be used for electronic medical record or payer billing systems. they are not paired with technology advancements that exist in the ojphi hands of consumers which could encourage patients to be more proactive with their healthcare. efforts today to link information and technology to engage consumers are championed by health plans and healthcare providers. engaging and empowering individuals to be proactive when presented with their medical records is not a simple problem to solve. it is not just a matter of making data available but making it actionable. actionable information may not achieve the desired success. but what if… this was augmented with another social mission? what if… the health community engaged consumers to help them fight disease outbreaks; what if… consumers become frontline activists to report occurrences and outcomes, and become "intelligent connections" to extend the right information in their social networks? this would encourage today's consumer technology to be better integrated with the clinical health information technology (hit). it would encourage continued investment in evolving and sustaining critical public health ecosystems. it would create opportunity to engage consumers, empowering each to be more proactive in supporting population health and their own healthcare. another large part of the health information system are immunization information systems (iis) where individuals who have received vaccines are documented in a confidential computer based system in a specific geographic area [ ] . the iis can be used for disease surveillance purposes and provide valuable information to public health authorities [ ] . as an extension of one of the existing iiss, myir was created where any state iis, pharmacy or provider can provide patients direct access to family state immunization records -regardless of the type of immunization information system used. providers can communicate to patients using myir to increase patient engagement. automated vaccine reminders can be sent using this system as well. during a pandemic, the need for accurate and timely information is vital. we propose that if there were direct public health agency communication channels to individuals -by building on existing immunization networks, the public would receive correct information quicker. furthermore, there is value that can be leveraged from social networks to advance public health efforts to manage disease events and in turn encourage consumers being more proactive in managing their own health care. one could envision a public-health-engagement-approach to empower consumers begins by offering individuals a challenge and a mission they care about. a mission that allows them to contribute to the social good with the added benefit of making them more attentive to their own healthcare. placing this mission in the palms of their hands through every cell phone is the first objective. the second is to create value for this phone's owner to become active in supporting the mission. the third objective is to provide a commonly understood health event that is a cornerstone component to this phone owner's health and welfare that helps launch them toward utilizing their complete health information profiles. universally the most significant public health event in the th century was the power of vaccines and applied immunizations to individuals and large populations [ ] . online journal of public health informatics * issn - * http://ojphi.org * ( ):e , the most significant action an individual can take to reduce their risk of a vaccine-preventable disease is to become vaccinated and stay up-to-date on their immunizations. however, there is a significant gap between believing in the value of an immunization and in ensuring one's own (and one's family's) immunizations are current. how many individuals really understand what the immunization schedule recommends or are proactive in ensuring they have no immunization gaps? how many of these same individuals in an outbreak or with news of a new disease ask the question "is there a vaccine and what are my risks?" the challenge is how to engage individuals directly, empower them to be advocates for their own health and in an outbreak become sources of trusted public health messages as they communicate within their social network, effectively supporting the higher-level mission. the lesson learned from every outbreak? that the public demands accurate, timely, and transparent communication from the government. if this public health information is communicated directly to this new evangelistic network, there is the potential to expand to larger consumer networks. a few separate experiments were conducted using myir. the first experiment aimed to increase sustainment. the engagement project was to reach out in an effort to increase sustainment by contacting users who had not used myir and accessed their data from the iis in over days. the baseline looked at number of users that were logging into myir more than once a month. the target was non-engaged users. in this category there were nearly , accounts. the second experiment aimed to engage the consumer for the flu shot. for this campaign, on november st, , an email was sent to , users that asked them a simple question, "did you get your flu shot?" if they selected yes, they saw a funny meme and received positive affirmation. if they clicked no, the message was an encouragement to get their flu shot before thanksgiving . in the third experiment, consumer engagement effort was initiated january , . capitalizing on the popularity of new year's resolutions around wellness this engagement experiment created a healthy lifestyle page within myir. it featured an arizona food blogger, simple, sassy and scrumptious, who offers readers nutritious easy meal ideas. the fourth experiment focused on outreach efforts where louisiana targeted users who had failed to complete the two step process to fully enroll for access to their immunization histories. forty-nine states have established immunization information systems (iis) to capture and consolidate patient immunization events as reported by their clinicians or pharmacists [ ] . hl is a set of standards for the transfer of clinical and administrative data between applications among the healthcare system's stakeholders. in nearly all these states, and soon all, secure hl data exchanges exist, allowing electronic health records (ehrs) and pharmacy systems to report a patient immunization event to the state iis in real time. furthermore, this infrastructure allows a clinician or pharmacist to review a patient's vaccine history and actionable immunization intelligence provided by public health decision support tools that using the latest advisory committee on immunization practices (acip) recommendations to identify immunization gaps and establish opportunities for closing these through communication at the patient point-of-care. the immunization ecosystem is based on what public health has spent the past quarter century developing. this is based on statewide population health environments consisting of key data assets and technical infrastructure for reporting, accessing and assessing immunization activity. additionally, these systems layer decision support, analytics, and communications across the entire population health environment. the value that the immunization ecosystem creates is the ability for all key "players" to integrate or connect. thus, a national immunization ecosystem exists today and, as it continues to evolve, the framework and platform are primed to impact the cost of health care and improve patient outcomes. the key is to fully extend the framework to the consumer, creating end-to-end communication channels between trusted health authorities and individuals. pandemic preparedness planning that takes advantage of iiss, their infrastructure and their players while engaging individuals to be consumer activists in an emergency response network, is potentially a new approach to accelerating individual health accountability while offering public health the ability to communicate valuable outbreak or pandemic information. by doing so, the outcome should influence day-to-day consumer behavior to mitigate the outbreak's impact on the population. the sars outbreak (with a -billion-dollar economic impact) [ ] , the h n pandemic, and the zika outbreak confirmed that the questions asked by the public in each of these events were: • is there a vaccine for this [ the ability for continued government and health authority responses to these questions is an important step toward managing the welfare of concerned populations while outbreaks are studied, and public health mitigation plans are put into place. the velocity of information, both accurate and inaccurate, cannot be controllable through current communication channels available to disseminate information to individuals, especially those most at risk. public health has an expectation and relies on their disease specific health education reaches at risk individuals, and is clearly understood and accepted. this reliability can be impacted by the social media and online consumer world today. much of the public's information and behavior during a pandemic will be influenced through these social media and online networks [ ] . individuals will search for data they choose to believe [ ] . once found, they will push this information to their family and friends and their social media sphere of influence [ ] . information from social media can pose as a challenge to stability for the trusted information that public health wishes to deliver in order to inform and encourage those at risk to take action [ ] . when a pandemic occurs, the need for accurate and timely information accelerates. if the odds of receiving accurate information during a pandemic are against you in the social media world, consider the opportunity if there were direct public health agency communication channels to individuals -by building on existing immunization networks. accurate communications would be the goal during a public health event. in washington and louisiana currently, over , consumers access their immunization records through real-time connections to the state iis through myir. the "players" in these states encourage individuals to enroll for access. once enrolled, an individual is connected to one of their health data attributes through the immunization platforms, which also establishes information access to trusted health agencies. it creates the opportunity to accelerate consumer engagement and activism in a pandemic or outbreak by layering digital communication to individuals to include those most at risk, and supporting the extension of this trusted communication through the individual's social network. . using existing infrastructure for immunization data exchange, establish communication links to trusted public health authorities supporting the following actions: a. inform and engage consumers by proactively alerting and notifying each individual of their immunization coverage gaps. b. identify the nearest locations capable of providing specific immunizations and antivirals to high risk populations. c. capture feedback and monitor outcomes or concerns of individual immunization events at their time of occurrence as well as over an extended period of time. d. capture surveillance of personal (family) health events, such as influenza or influenza-like illness. . integrate provider, pharmacy and laboratory patient influenza tests, public health influenza reporting, and overall tracking of the most recent outbreak. . integrate outbreak occurrences through alerts and visual displays (risk and outbreak maps). . provide social media exchanges to link immunization ambassadors and general social networks that can support the concept of "layering" to reduce the impact of an outbreak and to ensure a controlled, consistent and accurate dissemination of information. since , a number of immunization consumer engagement campaigns have been undertaken by stc to explore the power of direct links to individuals who have enrolled and have access to their immunization records. in a -day period from mid-august to mid-november, the stc consumer tool myir had , total user visits to the state immunization registry. of these % were returning users. in that same period , users visited myir more than once a month. they spent an average of minutes on the site each time and viewed seven different pages. typically, this included the initial login, requests for their immunization records, and reviewing the forecast or immunizations due or past due for each family member. in reviewing the individuals that enroll for user access to the immunization registry, they currently are from a specific demographic. the majority are within the ages of - , with % being female. this suggests the people who see the most value in myir are likely to be women with a family. % of people opened the initial email and . % of these individuals used myir within days to access their immunization records. % answered the question with % of these saying "yes" they got their flu shot. as a result, new immunizations were administered to these individuals within days. one nine-month-old family member received a full series of age appropriate immunizations. a . % increase in returning users were tracked and a . % increase in engaged users, again defined as logging in more than once a month. there was also a . % increase in average session duration. five hundred fifty-six emails were sent and a % open rate was achieved. the email contained a single step to finalize the enrollment and thus access to their immunization medical records. fifty of those who opened the email followed through and completed the process. respondents were asked: "did you get a flu shot this year? do you feel like you got the flu this year?" % responded they did receive the flu shot this year. of these . % felt they got the flu this year which equates in this group to a . % efficacy rate for this year's influenza vaccine. in february, cdc had determined the interim estimates for the effectiveness of the influenza were % [ ]. these consumer engagements were early experiments. they initially targeted to increase consumer access and utilization of the information contained in a public health immunization registry. they have moved toward soliciting input from active users to test the concept of empowering advocates to support a larger public health mission and engage with trusted communications from government. they created the thought processes that lead to the concept of extending the ie to proactively engage individuals to support public health missions, notably outbreaks and the next pandemic. the data, technical frameworks and infrastructure of the iiss form the environment to engage and empower consumers to be field assets to support outbreak mitigation efforts and be instrumental within the social networks if a pandemic were to occur. our aim was to illustrate examples where public health agencies using direct communication channels to individuals -by building on existing immunization networks, could increase the efficacy of reaching the public with correct information. the illustrations used to demonstrate the ojphi consumer engagement potential were not designed to test the hypothesis that consumer activism and the value of public health immunization registries in a pandemic would prove effective. they do demonstrate the potential of engaging individuals that have enrolled to access their immunization records from public health registries. they demonstrate that a subset of these individuals will provide information requested from public health authorities. it was through these early experiments and the growing data assets in state immunization systems that create a framework and technical platform to accelerate the potential value of engaging individuals in response plans for pandemic preparedness planning and support of today's outbreak. the next step is to begin to engage individuals to establish those that would be willing to provide ongoing information to public health specific to immunizations and disease occurrences. this would include developing experiments that test a social campaign to engage these individuals over the course of a year to ensure they remain activists in this network and then initiate efforts to encourage them to be proactive in their health care. the impact would be monitored in order to begin to establish a model with key parameters that would allow scaling across states and different demographics of users. the experiments illustrated were not statistically tested or compared to other sources.they were not designed to collect specific and more detailed information in support of an outbreak to determine if it is possible to enroll advocates and ensure consumer activism. however, sufficient assets and a growing community of individuals with access to their online immunization histories suggest a specific demonstration project to test this hypothesis is warranted. the paper presents a concept of empowerment and a few example consumer engagement tests that indicate the possible opportunity for public health. the results of the consumer engagements were not measured against a specific research goal to determine their effectiveness. there were no comparisons to other public outreach and education methods that would established the potential. the consumer outreach efforts were not regional, culturally, or demographic specific and as such there was no intent to determine the true public health education to populations approach. these are all recommendations for next steps although there is some justification to simply begin to enhance and expand the current process and develop a stronger strategy to be tested. this is the start. the immunization ecosystem is a robust environment to build upon. consolidated immunization information systems and technology supported by public-private partnerships have reached the dynamic where data and information is available across wide networks of users, stakeholders, and consumers. while health plans, providers and pharmacists struggle to engage their networks, by encouraging patients to be proactive in their healthcare, public health immunization assets may be the tipping point to accelerate this movement since the single most common health event is an immunization, required from birth to death. furthermore, pandemic preparedness planning is primed to step beyond just response actions and traditional communication plans to reach directly into areas where outbreaks are occurring, ojphi soliciting consumer activism through this ecosystem to report disease occurrences and disseminate accurate information as public health works to mitigate the outbreak. the hypothesis can extend one step further: if you are active in supporting a higher cause and technology is the facilitator, the belief is this would not only reduce the risk of outbreaks and help mitigate the economic impact and costs, but also create momentum for more people to become proactive with all their healthcare. continued investment through government immunization programs, centers of medicare and medicaid services (cms) / match programs, office of national coordinator (onc) efforts supporting innovation, and consumer empowerment are essential to continue to evolve and sustain the immunization ecosystem and data assets. as these assets create added value to each stakeholder, the government investment begins to create a positive return. the private sector benefits also grow. their investment in this same ecosystem is necessary. today, opportunities to use this ecosystem to drive down healthcare costs and improve patient outcomes are unlimited. the value of this virtual ecosystem to the nation is untapped. being ready for the next pandemic through everyday practice is unique. we are in unique times. players in this sense represent all key stakeholders that utilize immunization information and include public health, providers, pharmacists, payers, employers, school nurses, foster care, consumers, and more. for example, feedback such as: did you receive this year's influenza immunization? do you feel like you have the flu? (the dollar cost of the flu on the u.s. economy, according to cdc health affairs - , was $ . billion.) in a pandemic with a new vaccine, the question might be: do you feel you had a reaction to the vaccine? federal funding provided by onc has partially supported the expansion and testing of stc's myir since . sustainment of public health immunization registries and technical infrastructure is the subject of a separate stc paper, "sustaining the public health immunization ecosystem through public private partnerships." the content and concepts of this paper are based upon stc's years of working in the immunization registry sector, which includes implementing state public health iis, implementing electronic hl connections to every state iis from over , pharmacies and , providers, and using data and analytics to tell the story of the power of the ecosystem. chief talks about agency's successes-and his greatest fear. the washington post world health organization gets ready for 'disease x'. cnn [internet] list of blueprint priority diseases. world health organization about immunization information systems immunisation information systems -useful tools for monitoring vaccination programmes in eu/eea countries centers for disease control and prevention (cdc). . ten great public health achievements--united states immunization information systems (iis) fundamentals:overview and development. centers of disease control and prevention estimating the global economic costs of sars learning from sars: preparing for the next disease outbreak: workshop summary pandemic (h n) : frequently asked questions centers of disease control and prevention (cdc). questions about zika. cdc frequently asked questions on severe acute respiratory syndrome (sars). who [internet the effects of media reports on disease spread and important public health measurements why facts don't change our mind. the new yorker news sharing in social media: the effect of gratifications and prior experience a new dimension of health care: systematic review of the uses, benefits, and limitations of social media for health communication. eysenbach g we would like to thank theresa munanga for her editorial assistance. we would also like to thank all stc employees, especially those who assisted with the myir studies. key: cord- -fzuasf o authors: tadesse, degena bahrey; gebrewahd, gebremeskel tukue; gebre, gebre teklemariam title: knowledge, attitude, practice and psychological response toward covid- among nurses during the covid- outbreak in northern ethiopia, date: - - journal: new microbes new infect doi: . /j.nmni. . sha: doc_id: cord_uid: fzuasf o background coronavirus disease in (covid- ) is not only a deadly outbreak disease but also affects the mental status of the population, including nurses. nurses play a vital role in dealing with covid- victims. nurses’ infection control measures are affected by their knowledge, attitude, practice (kap), and psychological responses towards covid- . therefore, this study aimed to determine the knowledge, attitude, practice, and psychological response among nurses toward the covid- outbreak in northern ethiopia. the hospital-based cross-sectional study design was employed. the data were collected from march to april . data were collected through a self-administered questionnaire. the data were entered into epi-data manager version . and exported to spss for analysis. descriptive analysis was reported to describe the demographic, mean knowledge, attitude practice, and psychological response score of nurses. results a total of nurses participated in this study, resulting in a % response rate. of the participants, ( . %) were female. of the nurses, ( %), ( %), ( %), and ( . %) had good knowledge, good infection prevention practice, a favorable attitude, and disturbed psychological response towards covid- , respectively. the world health organization (who) declared that the covid- outbreak was a public hubei, china, first announced this at the end of december [ ] [ ] [ ] . this virus has low pathogenicity and high transmissibility capability [ ] . according to the who, the outbreak of coronavirus disease in has been a pandemic that infected more than million people at the time of writing this research paper and caused more than , deaths worldwide [ ] . in africa, morbidity and mortality reached greater than , and , respectively. of those, morbidities and deaths were from ethiopia [ ] . transmission of microbes among nurses is affected by hand disinfection, mask wearing , overcrowding, lacks of single room for isolation and is enhanced by the fact that some nurses have inadequate awareness of infection control practices [ ] . knowledge a self-administered structured questionnaire was used to collect the knowledge, attitude, practice, and psychological response towards the covid- outbreak. the questionnaire was adopted from other published articles [ ] [ ] [ ] [ ] [ ] [ ] [ ] , and further modification was done to fit the local context and research objective. two bachlor of science holder nurses were recruited for data collection, and one master of science holder nurse was recruited as a supervisor. overall, the data collection process was coordinated and supervised by the principal investigator. the total knowledge score for the nurses varied between (with no correct answer) and (for all correct answers), and a cut-off level of ≤ was evaluated as poor knowledge, and > indicated good knowledge [ ] [ ] [ ] [ ] [ ] . the question regarding attitude was eleven (with a minimum score of and a maximum score of ). the attitude score was based on a -point likert scale, in which a score of to was j o u r n a l p r e -p r o o f given from strongly disagree to strongly agree. a mean score > (answering for strongly agree or agree) was carried out as a favorable attitude, and a score of to indicated an unfavorable attitude (answering strongly disagree or dis-agree or neutral) [ , , , ] . practice to prevent covid- the question regarding the practice was fourteen (with minimum score and maximum score ). the score of the practice was based on points, in which a score of to was given from never to always. a mean score > (answering for always or most of the time or sometimes) was carried out as having good practice, and a score of ≤ indicated a poor practice (answering never or occasionally) [ , , ] . psychological response to covid- the question regarding the psychological response was nine (with minimum score and maximum score ). the psychological response score was based on points, in which a score of to was given from not disturbed at all to almost daily disturbance. a mean score > (answering for almost daily disturbance or disturbed for more than days) was carried out as having psychological disturbance, and a score of ≤ indicated having no psychological disturbance (answering not disturbed at all or for a few days disturbance) [ ] . (table ) . j o u r n a l p r e -p r o o f the nurses' attitude towards the covid- measured eleven questions using five criteria and by proving numerical value ( = strong dis-agree, = dis-agree, =neutral, =agree, and =strong agree) (table ) . the psychological response towards the covid- was measured using nine questions using four criteria and by proving numerical value ( =: not disturbed at all, = for a few days disturbance, = disturbed for more than days, = almost daily disturbance) ( the datasets used and/or analyses during the current study are presented within the manuscript and available from the corresponding author on reasonable request. nurses had nearly three-fourths of good knowledge and favorable attitudes regarding covid- . more than two-thirds of the nurses had good infection prevention practices towards covid- . nurses had an almost disturbed psychological response to covid- . the who and the ministry of health still must provide more information for better control of the infectious the data presented in this study are self-reported and partly dependent on the participants' honesty and recall ability; thus, they may be subject to recall bias abbreviations covid- : corona virus disease in , who: world health organization written consent was obtained from the respondents. confidentiality was assured for all the information provided, and no personal identifiers were used on the questionnaire mental health strategies to combat the psychological impact of covid- beyond paranoia and panic coronavirus envelope protein: current knowledge. virology journal world health organization declares global emergency: a review of the novel coronavirus (covid- ) estimating the asymptomatic proportion of coronavirus disease (covid- ) cases on board the diamond princess cruise ship . world health organization. coronavirus disease (covid- ) pandemic characteristics of and important lessons from the coronavirus disease (covid- ) outbreak in china: summary of a report of cases from the chinese center for disease control and prevention meta-analysis of the reasoned action approach (raa) to understanding health behaviors social media and outbreaks of emerging infectious diseases: a systematic review of literature assessment of iranian nurses' knowledge and anxiety toward covid- during the current outbreak in iran. archives of clinical infectious diseases knowledge and attitude toward covid- among healthcare workers at district knowledge and attitude toward covid- among healthcare workers at district hospital knowledge, attitude and practice regarding covid- among health care workers in henan novel coronavirus (covid- ) knowledge and perceptions: a survey on healthcare workers. medrxiv knowledge, attitudes, and practices towards covid- among chinese residents during the rapid rise period of the covid- outbreak: a quick online cross-sectional survey assessment of iranian nurses' knowledge and anxiety toward covid- during the current outbreak in iran. archives of clinical infectious diseases knowledge and attitudes towards middle east respiratory syndrome- coronavirus (mers-cov) among health care workers in south-western saudi arabia. east mediterr health j is pakistan prepared for the covid- epidemic? a questionnaire-based survey coping responses of emergency physicians and nurses to the severe acute respiratory syndrome outbreak. academic emergency medicine community responses during the early phase of the covid- epidemic in risk perception, information exposure and preventive measures. medrxiv authors thank all staff of aksum university, college of health science and comprehensive specialized hospital, data collectors and supervisors who had a dedicated output. the authors declare that they have no competing interests. key: cord- -jocwiafy authors: ahmed, naseer; shakoor, maria; vohra, fahim; abduljabbar, tariq; mariam, quratulain; rehman, mariam abdul title: knowledge, awareness and practice of health care professionals amid sars-cov- , corona virus disease outbreak date: - - journal: pak j med sci doi: . /pjms. .covid -s . sha: doc_id: cord_uid: jocwiafy objective: to assess the knowledge, awareness and practice level of health care workers towards corona virus disease - (covid- ). methods: a cross sectional study was conducted by administering a well-structured questionnaire comprising of three sections including knowledge, attitude and practice amongst health care professionals in various hospitals and clinics, over a duration of two months ‘feb-march’ . the data from participants were collected manually as well as through online survey registered on www.surveys.google.com, using a validated questionnaire. the questionnaire comprised of three sections assessing knowledge, awareness and practice of participants. the descriptive analysis was carried out for demographics and dependent variables with statistical program for social sciences. spearman test was used to detect any relationship between the health care professional response with respect to their gender and level of education. a p value of < . was considered statistically significant. results: more than half ( . %) of the health care professionals were working in a hospital setting. fifty two percent of health care professionals had awareness and % were practicing adequate measures to combat covid- . the majority ( . %) believed that the sign and symptoms are similar to a common flu and the main strata of population that could be affected by covid- are elderly ( %). seventy three percent of participants did not attend any lecture, workshop or seminar on covid- for awareness purpose. sixty seven percent of health care professionals were practicing universal precaution for infection control and . % were using sodium hypochlorite as a surface disinfectant in dental surgeries. there was no significant relationship (p > . ) between the health care professionals’ responses with gender and their education level. conclusion: the study suggests that the vast majority of the health care professionals have adequate knowledge and awareness related to covid- . however some aspects of practice of health care professionals were found to be deficient including, following cdc guidelines during patient care, acquiring verified knowledge related to covid- , disinfection protocol and the use of n- mask. mandatory continued professional development programs including lectures and workshops on covid- for all health care professionals are the need of the hour, to manage the pandemic and limiting the morbidity and mortality related to it. coronavirus disease (covid- ) is a highly contagious viral pandemic affecting more than one million people in more than countries around the globe. it was declared as a public health emergency of international concern (pheic) by who in jan' . it is caused by a new strain of novel coronavirus (sars-cov- ) and was first reported in december in the chinese province of wuhan. the main route of human-to-human transmission is through respiratory droplets (coughing and sneezing). it is also transmitted from contact (shaking hands) with an infected person or a contaminated surface and transferring it to the mouth, nose or eyes. covid- has an extended incubation period of - days , with variable severity from asymptomatic to life threatening symptoms among different individuals. infected individuals can be asymptomatic, therefore not just making the diagnosis difficult but preventing the transmission of the disease an arduous challenge. [ ] [ ] [ ] covid- is reported to manifest clinically with one or more mild symptoms of fever, cough, headache, body aches, dyspnea and fatigue, with symptomatic recovery within a few weeks. while severely affected individuals show manifestation of progressive respiratory distress syndrome due to the lung substance damage and edematous changes caused by the virus in leading to shock and death in some cases. the mortality rate range is . to . % based on the early data from different regions. a majority of middle to elderly patients with comorbidities including, tumor, cirrhosis, hypertension, coronary heart disease and diabetes are reported dead as a result of covid- infections. however the data available regarding risk factors of covid- is still preliminary. to date, no specific antiviral treatment has been confirmed to be effective and no vaccines has been developed for its prevention. the disease is managed with appropriate symptomatic treatment (antipyretics, analgesics) and supportive care along with training for prevention and control with isolation, and disinfection. the best prevention is to avoid being exposed to the virus . infection preventive and control (ipc) measures that may reduce the risk of exposure include use of face masks; covering coughs and sneezes with a flexed elbow; regular hand washing with soap or disinfection with hand sanitizer containing at least % alcohol; maintaining a distance of . to meters from humans; and refraining from touching eyes, nose, and mouth with hands. health care professionals (hcp) including nurses, doctors, intensivist, paramedics, dentist and other hospital staff are playing a critical role throughout the world in combating, preventing and managing patients affected by however multiple reports of infection and fatalities of hcps have surfaced in the last few weeks, which are of grave concern. awareness, knowledge and practice attitudes among hcps are critical in the management of viral diseases and their role in this pandemic is no different. due to the reported infection rates, it was hypothesized that the knowledge and practice of hcps related to covid- will be deficient. to prevent covid- infection and disease among hcps the primary steps should involve establishing an estimate of their knowledge, awareness and practice towards the covid- infections, in addition to an awareness and education program with updated evidence. therefore, the present study aimed to evaluate the knowledge, awareness and practice towards covid- infection and disease among health care professionals (doctors, dentist, nurses, assistants, technicians and paramedics). the ethics and review committee of aidm (ec/ / / ) reviewed and approved the project. this cross-sectional study was carried out on health care professionals (hcp) working at different hospitals and clinics, including both the public and private sector. a total of hcps including doctors from the medical and dental fields alongside nurses, medical and dental assistants, paramedics and laboratory technicians were approached in the study from february to march . a consent statement for voluntary participations was included in the questionnaire for all subjects to understand prior to their agreement. data was collected using a well-structured questionnaire that comprised of pre-defined responses including the demographic, knowledge (k), awareness (a) and practice (p) assessment sections. a group of medical and dental academic staff members not involved in this research, evaluated the content and validity of the questionnaire employed to evaluate the kap levels of hcps. the consistency of response evaluated by cronbach's alpha was . . the first section of the questionnaire comprised of six closed ended questions about the demographic details along with education levels, designation, type of workplace and working sector of participants. section two, had a total of eleven questions focused on knowledge level of health care professional. these included knowledge regarding the awareness, etiology, mode of transmission, incubation period, sign and symptoms, duration of presence outside the human body, age group of individuals, mortality rate, ways of prevention and treatment options currently available for covid- . the third section of questionnaire had fourteen questions with regards to attitude and practice of hcp's which comprised of questions related to contagious nature, prevention of spread, animal to human transmission, reinfection rate in humans, availability of vaccine, community threats, practice of cdc guidelines and patient care. the third section also included encountering of patient, lectures and workshops for knowledge of covid- , washing of hands before and after patient treatment, following universal precautions for infection control and use of surface disinfectant to contain and eliminate virus clusters of covid- . the questionnaire was distributed in two phases; a manual phase in which printed questionnaires were hand distributed and responses were recorded by non-probability convenience sampling method. in order to gain an understanding of how much covid- was understood amongst health care professionals at the time of global pandemic. the survey questionnaire was administered to the hcps serving at various medical and dental centers. in the online phase, questionnaires were uploaded and disseminated through google surveys by forwarding web page links through emails. the questionnaire link was also distributed through social media outlets including, whatsapp, facebook, and twitter. no obligation was placed, and all participants were kept anonymous. online response record, online survey link was available for the complete study duration. the data collected was analyzed through statistical package for social sciences (spss-version ). descriptive statistics and spearman correlation were performed, considering p < . as statistically significant. a total of hcps at a response rate of % completed the questionnaire. one hundred and ninety eight hand distributed and questionnaires sent through digital portals were completed by participants. the descriptive data of the participants is presented in table- i. out of the total participants, were males and females with a common age range of . to . years ( %). among the included participants, were dentist, were medical doctors and hospital auxiliary staff i.e. technicians, hygienist, nurses, and assistants. by designation, were general medical or dental professionals and were specialist's and consultants. hcps belonged to private and worked at government, primary care or specialist centers and hospitals. majority of participants, were working in hospital while were in clinics. the present study reported no significant relationship between the dental care professionals' responses with gender and their education level (p< . ). the knowledge level of health care professionals towards covid- is presented in table- table- iii. about . % were aware that it is contagious in nature and % considered themselves updated with management guidelines and however more than quarter of the participants ( . %) were not aware of the cdc guidelines. accordingly, . % believed that disease can be transmitted from animals to humans and discouraged them in hospital settings. a large number of participants ( . %) believe that humans are infected only once and a majority of patients recover from the disease. within participants, . % of hcps were aware, that a vaccine is not available hence prevention and basic standards should be followed, however almost a quarter participants either were unaware or thought that there is a vaccine available for sara-cov- . . % believed that covid- is a serious threat to the local community if not controlled. only . % of the participants came across a covid- patient in their workplace. seventy three percent of participants did not attend any lecture, workshop or seminar on covid- for awareness purpose. . % were practicing washing hands soap and use of alcohol-based sanitizer. nearly eighty four percent were using surgical mask when managing general patients, while only . % favored the use of n- masks. similarly, . % of health care professionals were practicing universal precaution for infection control and . % were using sodium hypochlorite as a surface disinfectant in dental surgeries. covid- infection is spreading worldwide and has become the single most important global concern. health care professionals who are in close contact with the infected patients play a major role in infection control. multiple reports have surfaced regarding the infection and deaths of health care professionals from coivd- infections. explanations for increasing covid- among hcps may include, knowledge and practice towards sars-cov , availability of personal protective equipment (ppe), strength and support of the health care system and continued research and its interpretation. therefore, the present study aimed to investigate the trends in knowledge, awareness and practices amongst health care professionals towards covid- disease control during the outbreak in . the current knowledge and awareness of hcps as perceived in the study was adequate. however some of the practice requirements observed as a study outcome were compromised. therefore the hypothesis was partly rejected. the overall response rate was % that is comparatively high in comparison to questionnaire-based studies previously. , this could be attributed to the immediate concern of the participants (health care professionals) to contribute towards finding solutions to curb the contagious viral pandemic. hcps routinely take standard precautions considering each patient as infected i.e able to transmit infection. however, considering the highly contagious nature of the sars-cov , and in some cases asymptomatic occurrence, the usual daily protective measures taken may not be effective and extreme strict cross infection protocols are recommended. in the present study among hcps, . % were aware that covid- is contagious in nature. this finding is in line with a research on iranian nurses, where . % believed it to be contagious. this study found that % of the respondents were updated and practiced cdc guidelines for all patients. this improvement in precautionary measures are found in similar studies. however, poor knowledge levels persist amongst health care workers as shown in a previous study and greater efforts are required to create and spread awareness. furthermore . % considered the virus to be a problem for our community. this perception was reflected by % of the participants who practiced cdc guidelines for all patients. but nearly quarter participants did not practice the cdc guidelines, putting themselves and others at risk of infection. a greater emphasis is also required on use of surface disinfectants by the health care workers, as only % of hcps practiced the use for hydrogen peroxide for disinfection of the virus. hydrogen peroxide vapor is an effective viricidal agent for structurally distinct viruses dried on surfaces and is recommended along with % ethanol and quaternary ammonium compound for viral disinfection. the contagious nature of the virus warrants the existence of sound knowledge regarding incubation period and symptoms amongst the health care workers. in the present study, . % of the health care professionals believed that covid- has a - days incubation period. this was in accordance with a similar web-based study amongst the health care workers where . % were found to believe that the symptoms appear in about - days. in the same study it was observed, that . % of hcps had an opportunity to attend a lecture/workshop/ course on covid- , while in our study only . % attended a professional scientific event for covid- update. by contrast a similar study reported . % of the health care professionals completed a covid- training program. this shows the need of training and courses in our region that can be conducted online to enhance the knowledge of our health care workers. in addition, multiple online webinars are provided by the cdc and world health organization (who) for hcps to access update knowledge in relation to covid- . moreover, . %. participants also felt that there is a possibility of reinfection in previously infected individuals from the virus. however, to our knowledge from indexed literature there is no evidence of re-infection of individuals, and further studies in this regard are warranted. it is also observed the majority of hcps learned about the facts of covid- from multiple media sources, which is in line with the findings of similar previous studies. although it is encouraging to know that information is readily available about the outbreak, however, one has to be very careful about the reliability and authenticity of the source, as misinformation can do more harm than good. the study presents preliminary findings related to the knowledge and practice of hcps in association with covid- pandemic in pakistan. however one should interpret this data cautiously, due to the underlying cultural and contextual factors. in addition the wide variety of participants, may have influenced the outcomes of the study. based on these critical findings it is suggested that although the majority of hcps displayed adequate knowledge and awareness, there are aspects of the covid- disease, which still need to be better understood, and improvements in the practice of hcps when managing patients in the covid- pandemic are recommended. the rapidly spreading covid- has become a challenge for health care professionals who are in close contact with patients in decreasing the spread by means of efficient use of preventive measures. all hospitals and clinics should establish pre-check triages for all the patients as well as the staff; patients should be asked regarding their health status and travel history. besides that, temperature of the patients and their attendants should be evaluated once they are in the hospital premises; if the patient has travel history within past two weeks, they must be placed in quarantine for a minimum of days. patients with continuous high fever along with any other symptom including, sore throat persistent cough, head or body aches, diarrhea should be registered as a covid- patient until proven otherwise and referred to the designated hospital facilities. all elective hospital medical, dental and surgical procedures should be deferred except emergencies, and use of recommended ppes including n- masks must be practiced. disinfection of the premises and instruments with hydrogen peroxide and/or % ethanol before each emergency procedure is recommended. continued education program including seminars, webinars and courses, on updated findings related to covid- infection prevention, modes of transmission and management protocols for the hcps must be made mandatory. in addition, there is a need for continued medical, financial and psychological support for the health care professionals for the continued risks they are exposed daily in battling the covid- pandemic. further studies are recommended to identify the reasons for reported high infection rates of hcps. the study suggests that the vast majority of the health care professionals have adequate knowledge and awareness related to covid- . however, some aspects of practice of health care professionals were found to be deficient including, following cdc guidelines during patient care, acquiring verified knowledge related to covid- , disinfection protocol and the use of n- mask. mandatory continued professional development programs including lectures and workshops on covid- for all health care professionals are the need of the hour, to manage the pandemic and limiting the morbidity and mortality related to it. epidemiology, causes, clinical manifestation and diagnosis, prevention and 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cord- -nb sxfax authors: bouso, josé carlos; sánchez-avilés, constanza title: traditional healing practices involving psychoactive plants and the global mental health agenda: opportunities, pitfalls, and challenges in the “right to science” framework date: - - journal: health hum rights doi: nan sha: doc_id: cord_uid: nb sxfax nan perspective traditional healing practices involving psychoactive plants and the global mental health agenda: opportunities, pitfalls, and challenges in the "right to science" framework josé carlos bouso and constanza sánchez-avilés introduction: global mental health and traditional medicines the global mental health (gmh) movement aims to establish a world in which every human can access mental health services based on two fundamental principles: respect for human rights and evidence-based treatments. despite being criticized, especially for its neocolonial tendency to impose psychiatric systems that defy local epistemologies, this movement is garnering increasing attention. the anti-psychiatry movement led to the first mental health reforms based on human rights, which notably influenced world health organization (who) policies and the development of ethnopsychiatry. however, despite the vast anthropological literature supporting the importance of traditional health systems for the well-being of local communities, the recognition of traditional medicines and healers is highly marginalized within the gmh agenda. for example, who's mental health action plan - acknowledges the value of traditional medical systems only subsidiarily, qualifying them as "informal": "greater collaboration with 'informal' mental health care providers, including families, as well as religious leaders, faith healers, traditional healers, school teachers, police officers and local nongovernmental organizations, is also needed." similarly, the lancet commission on global mental health and sustainable development's report mentions traditional healing systems only when stating that "[g]lobal mental health practitioners have shown that integrating understanding of local explanatory models of illness experiences is possible while respecting the complementary role of western biomedical and local traditional approaches to treatment." paradoxically, in most parts of the global south, traditional healers are more numerous than mental health workers, and they constitute the main health resource that local populations use and believe in. for example, in ghana, with a population of million, there are only psychiatrists, psychologists, community mental health officers, and , mental health nurses. in contrast, around , traditional healers are reportedly operating in this country. however, there is a scarcity of institutional documents and international gmh proposals that consider investing in traditional medical practices and research. in today's globalized world, a large diversity of people from a broad range of genetic and cultural backgrounds coexists and travels throughout various territories and countries. traditional healers conduct ceremonies in western countries, and westerners travel into indigenous territories in search of traditional treatments. thus, different medical systems, backed by their respective epistemologies, coexist. if traditional practices and epistemologies are not properly addressed within the gmh movement and who's mental health action plans, this may pose a challenge to health-related human rights. among these rights, it is worth noting that everyone has the right to enjoy the highest attainable standard of physical and mental health and the right to enjoy the benefits of scientific progress and its applications. in specific cases where psychoactive plants containing internationally scheduled substances are used for mental health purposes, as is the case with certain south american plants (containing what western pharmacology considers hallucinogenic compounds), people are vulnerable to possible criminal prosecution. in the case of indigenous peoples for whom those plants are part of their traditional medical systems, the right to access their traditional medicines and to maintain their health practices may also be violated. thus, this complex scenario produced by contemporary globalization offers some challenges to reflect upon. traditional healing practices involving psychoactive plants: human rights challenges worldwide interest in ayahuasca and related traditional amazonian medical systems is typical of contemporary globalization. ayahuasca is a highly widespread tool within traditional amazonian health systems. in , pioneering work that brought together all available ethnographic information on ayahuasca found over bibliographical references, referring to over different amazonian ethnic groups in which it was traditionally used and over different vernacular names given to the decoction. today, those figures may represent only a small part of the bigger picture. ayahuasca is a decoction containing the leaves of the vine banisteriopsis caapi, which is rich in harmaline alkaloids, and of the shrub psychotria viridis, which contains dmt (n,n-dimethyltriptamine), which is a schedule i substance controlled by the convention on psychotropic substances. although ayahuasca itself is not scheduled in the international drug control treaties, its use is prosecuted in many countries, even in the case of indigenous peoples who travel outside their original territories. ayahuasca became so popular among westerners as a self-care practice that even psychiatrists and pastoral counselors have called for their colleagues to be ready to discuss spiritual, healing ayahuasca experiences with their clients, despite their epistemological divergence from psychiatry and their ontological divergence from monotheistic religions. also, ayahuasca's adverse effects are frequently reported in the scientific literature. an initial epistemological challenge becomes evident here. both scientific and traditional mental health treatments often involve psychoactive compounds. however, biomedicine views mental disorders as biochemical imbalances that psychoactive drugs might restore; meanwhile, amazonian medicine views spiritual forces as being at work and psychoactive plants as a means to harmonize the individual with the surrounding spiritual world. this harmonization tries to achieve an alignment between the individual, the community, the ecosystem, and even the geographical territory. the case of ayahuasca is also paradigmatic, as it shares its neurochemical mechanism of action with antidepressants. whereas in biomedical systems clinical trials are used to demonstrate the safety and efficacy of psychoactive drugs, regarding traditional ethnobotanicals, safety and efficacy are j. c. bouso and c. sánchez-avilés / perspective, mental health and human rights, - demonstrated by the long history of use. although western countries accept traditional plants as medicines, their safety and efficacy must be proven according to biomedical criteria. this can get really challenging when applied to non-biomedical medical systems with conceptions of safety and efficacy that may not be equivalent. an important consideration arises here: article of the international covenant on economic, social and cultural rights recognizes everyone's right to enjoy the benefits of scientific progress and its applications, and the states parties that signed this covenant agreed to respect the freedom indispensable for scientific research. in practice, these rights are conceived of and applied in the context of western epistemologies, leaving aside traditional approaches to mental health and related research. these issues are addressed (although not exclusively within the context of mental health) in the recently adopted general comment by the united nations committee on economic, social and cultural rights. the general comment states that "[l]ocal, traditional and indigenous knowledge, especially regarding nature, species (flora, fauna, seeds) and their properties, are precious and have an important role to play in the global scientific dialogue" and that "[i]ndigenous peoples and local communities all over the globe should participate in a global intercultural dialogue for scientific progress, as their inputs are precious and science should not be used as an instrument of cultural imposition." nevertheless, traditional treatments should not be the only option available, and "states parties must guarantee everyone the right to choose or refuse the treatment they want with the full knowledge of the risks and benefits." the right to science is essential in order to adopt a perspective based on human rights and evidence, since various health-related human rights rely on the right to science, such as everyone's right to enjoy the highest attainable standard of physical and mental health. this is especially relevant, as mentioned above, in the case of indigenous peoples, and even more so in terms of their use of plants with psychoactive properties that are under international control. the international guidelines on human rights and drug policy, developed by several united nations agencies, academics, and civil society representatives, echo this problematic, specifying that states should "refrain from depriving indigenous peoples of the right to cultivate and use psychoactive plants that are essential to the overall health and well-being of their communities." furthermore, general comment explicitly states that "the prohibition of research on those substances is in principle a limitation of this right." considering that the general comment defines "science" as encompassing both natural and social sciences, this makes ethnographical research an option, which could be more reliable and feasible than biomedicine as a source of evidence for evaluating traditional medicines involving psychoactive plants. however, the application of non-biomedical methodologies can be challenging since, as the same general comment affirms, the post-colonial and biomedical-oriented aspects of the right to science several western epistemologies-such as psychoanalysis, certain approaches in psychology, and other social sciences (including certain ethnographies within anthropology)-cannot always meet these falsifiability and testability criteria. although those disciplines and epistemologies are also based on reason, cumulative knowledge, and experience, their ontological assumptions may not fit within the exigencies of scientific methodologies. even research in biological psychiatry might not always meet the criteria of falsifiability and testability, since it has various flaws. the etiopathogenesis of mental disorders is completely unknown; there is not a single psychopharmacological treatment that offers a cure, and, at best, psychiatric drugs serve n u m b e r health and human rights journal to treat acute symptoms (such as panic attacks and psychotic breakdowns) but over the long term can be ineffective and potentially dangerous. radical critics of psychiatric drugs consider them to actually be part of the problem regarding the chronicity of mental illnesses, rather than part of the solution. this inefficacy could be partly due to the poor heuristic models of mental illnesses. in sum, science applied to mental health demands that other disciplines and epistemologies meet methodological criteria that psychiatry itself does not always fulfill. a broader framework regarding the assessment of mental health systems should be developed in which different epistemological approaches, including indigenous ones, are considered. global mental health, globalization, and plants containing scheduled compounds contemporary globalization involves not only the intentional export of scientific mental health systems from the global north to the global south. rather, a new and interesting phenomenon is also occurring whereby traditional medicines are traveling from the global south to the global north. some traditional medicines involving plants that contain psychoactive constituents-such as ayahuasca (containing dmt), san pedro and peyote (two cacti originally from the andean region and mexican deserts, respectively, that contain mescaline), and iboga (a plant from equatorial africa containing ibogaine)-are gaining increasing popularity all over the world. among them, ayahuasca is probably the most popular and widespread. ayahuasca has diverse uses among amazonian cultures, such as in rites of passage from childhood to adulthood, to strengthen community bonds in interethnic festivals, as a sacrament (for example, in brazilian ayahuasca religions), and even as a spiritual tool to resist neocolonial extractivism. however, ayahuasca is used in amazonian cultures mainly as a tool for healing, which has been widely documented in the ethnographic literature. biomedical scientists have also widely studied its neuropharmacology, neuropsychiatric long-term effects, and therapeutic potentials, find-ing promising results for mental health disorders such as major depression, drug dependence, grief, eating disorders, borderline personality disorders, and post-traumatic stress disorder. contrary to what happened with the importation of other psychoactive plants traditionally used in the americas, such as coca and tobacco, the globalization of ayahuasca has seen its incorporation into ritualistic settings where it is used similarly to how it is used in its original context. these rituals have been conceived of as novel self-care practices. meanwhile, thousands of westerners travel to amazonian regions each year seeking spiritual enlightenment and healing from their physical and psychological conditions. biomedical researchers are also starting to report the psychological outcomes of traditional ayahuasca practices among western participants. this phenomenon suggests that the gmh paradigm could lead to a turning point where, contrary to the assumption that the western mental health model should and will expand, we are instead witnessing the expansion of traditional forms of healing beyond their native contexts. this is evident in the case of traditionally and ritually used psychoactive plants, especially ayahuasca. the manner in which international drug control conventions have been drafted assumes that traditional cultures will never be capable of expanding their influence to other territories and societies. this has not been the case. ways of healing previously considered outdated and unscientific are being recognized as highly useful and less costly in terms of adverse effects. furthermore, amazonian health systems, based on a world view that appreciates alignment between the individual, the community, the ecosystem, and the geographical territory, may serve as a model for dealing with our mental health crisis that, with the climate emergency and the covid- pandemic, will dramatically increase. thus, the gmh agenda should start to recognize the immense value of traditional medicines based on psychoactive plants, the ethnographic literature should be used as a legitimate source of evidence regarding safety and efficacy, and research budgets should be allocated for multidisciplinary approaches to study non-in-stitutionalized traditional medicines, such as ayahuasca healing systems. furthermore, indigenous epistemologies should be carefully respected because traditional healers are the true experts on the medical use of these sophisticated technologies, and appropriate frameworks should be created in which they are considered legitimate knowledge systems that should be protected not only under the umbrella of cultural rights and the protection of cultural heritage, but also within the frameworks of the right to science and the right to health, in compliance with multiple international treaties and united nations declarations. the western popularization of non-institutionalized, traditional healing systems implies multiple challenges that deserves in-depth reflection. in fact, this is already happening in many parts of amazonia with ayahuasca, in mexico with peyote, and in gabon and equatorial guinea with iboga. biomedical and cultural misappropriation, the over-exploitation of natural resources for commercial purposes, medicinal plant tourism that threatens the viability of local community rituals, and disruptions of egalitarian traditional social systems perverted by economic inequalities are among the challenges faced. these challenges can be overcome only if they are dealt with from a perspective of reciprocity that extends beyond the gmh agenda's narrow recognition of traditional medical systems involving psychoactive plants. it is therefore necessary to invest in indigenous epistemological research and practices in order to truly protect indigenous peoples' right to science, since this right, beyond its concern with science, involves much more complex economic and sociopolitical dimensions. decolonizing global mental health: the psychiatrization of the majority world world health organization, mental health action plan the lancet commission on global mental health and sustainable development a (xxi) ( ), arts. , . . united nations general assembly, res. / ayahuasca: from the amazon to the global village vegetalismo shamanism among the mestizo population of the peruvian amazon, stockholm studies in comparative religion no ayahuasca: from the amazon to a city near you united nations development programme, joint united nations programme on hiv/aids, world health organization, and international centre on human rights and drug policy does long term use of psychiatric drugs cause more harm than good? conversaciones entre médicos y seguidores del yagé: gobierno proprio, territorio y conocimiento ancestral bouso and c. sánchez-avilés / perspective, mental health and human rights chamanes, ayahuasca y sanación (consejo superior de investigaciones científicas translational evidence for ayahuasca as an antidepressant: what's next? ayahuasca and public health: health status, psychosocial well-being, lifestyle, and coping strategies in a large sample of ritual ayahuasca users therapeutic potential of ayahuasca in grief: a prospective, observational study short-term treatment effects of a substance use disorder therapy involving traditional amazonian medicine ayahuasca's entwined efficacy: an ethnographic study of ritual healing from 'addiction key: cord- - d abhg authors: herten-crabb, asha; davies, sara e title: why who needs a feminist economic agenda date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: d abhg nan in september, , alan donnelly and ilona kickbusch called for a chief economist at who. such a position, they argued, would enable who to better advocate for greater recognition of, and thus action on, the interdependency of health and the economy. we support this proposal: recognition of the interdependence of health and the economy is vital for who to achieve its mandate: "the enjoyment of the highest attainable standard of health… without distinction of race, religion, political belief, economic or social condition". given this mandate, who should be more ambitious than the appointment of one economist. a more strategic and enlightened approach, especially in the aftermath of the coronavirus disease (covid- ) pandemic, would be for who to embrace and articulate a feminist economic agenda. a feminist economic agenda interrogates power dynamics and peoples' relative access to and use of wealth and resources. a feminist economic lens that incorporates intersectionality must address the power dynamics between genders and acknowledge the power relationships between nation states, ethnicities, ages, abilities, and other dimensions of diversity, and how they are interconnected with gender inequality and the economy. a feminist economic approach is consistent with how public health is taught and sometimes practised: that health, and access to health care, is interdependent not only on the economy but also on all other social and commercial determinants of health. , who has estimated a shortfall of million health workers by , largely in low-income and middle-income countries. women comprise more than % of the global health workforce, but who research into the state of gender equity in the health workforce has revealed systematic gender biases, inequities, and discrimination. a feminist economic approach recognises the systems of disadvantage and discrimination that lead to this inequality. minority ethnic status, class, education, and sexuality determine who is represented in unpaid community health-care worker roles. the unpaid and low paid labour of women has contributed to profits for private health-care providers and saved the bottom line of health spending in national budgets: capitalism and patriarchy combine to systematically undervalue social reproductive labour-ie, unpaid care roles as women's work. governments' ability to fund health-care services is dictated by their revenue and fiscal policy space. for the world's poorest countries, revenue and fiscal space have been largely controlled by the policy advice and loan conditionalities of international financial institutions such as the international monetary fund (imf) and the world bank. the imf, the world bank, the g , and the g have championed gender equality, while the g and g have highlighted the necessity of universal health coverage (uhc) and the world bank aims to support pandemic response through its pandemic emergency financing facility. yet the imf and the world bank continue to prioritise austerity measures and "private sector first" strategies that systematically undermine the ability of governments to provide public services and achieve uhc. mark henley/panos pictures on promotion of gender equality to the development of a systematic approach for evaluating the implications of its austerity policies on gender inequality, health delivery, or outcomes. , the key funders of the imf and the world bank, and those that hold the greatest number of executive board votes, are g and g members. these blocs comprise nations (canada, france, sweden, australia, and the uk) with domestic uhc and feminist or genderfocused development policies, although not without their criticisms. these same countries also fund the international financial institutions that promote austerity policies that reduce public spending on health services and wages. , the world's health care is largely delivered by women, but most decision making, including national budgets, lies in the hands of men. initiatives such as women in global health and women leaders in global health have raised the importance of increasing the numbers of women in health decision-making roles and institutions. however, undertaking a feminist analysis of health delivery and resourcing is not gender specific-men can be feminists, and not all women will be. a feminist economic approach to health requires that all people at all levels of healthcare decision making reorient their notion of wellbeing to include gender equality for women in all their diversities. feminist knowledge informs what we count as costs and savings: the national income saved from women's low wages or volunteerism as health-care workers; the benefit to national budgets and health outcomes when there are gender-based violence health-care prevention programmes; and the negative burdens carried by health-care workers exposed to violence, harassment, and exploitation when their work is located in unregulated environments, including homes, non-governmental organisations, and provincial health clinics. a who economic engagement strategy that does not address the social and political determinants of health delivery, resourcing, and decision making risks perpetuating the falsehood that health is a technical enterprise that can be achieved in a silo. health programmes that ignore gender, race, human rights, capitalism and corporatism, sovereign debt, donor influence, (neo)colonialism, and post-conflict transitions will fail to advocate for the necessary political economic interventions that underpin effective health delivery and outcomes. the question remains whether a feminist economic agenda led by who would hold sway over decision makers in governments, political blocs, and international financial institutions. the answer lies in political momentum and who's knowledge of the social and commercial determinants of health. as international financial institutions and donor groups like the world bank and the organisation for economic co-operation and development embrace gender equality and the uhc agenda, who has the opportunity to use its access to these institutions to demonstrate the necessity of a feminist economic approach to build better, more equitable ways to steer sustainable economies that prioritise health and gender equality as mutually inclusive. we declare no competing interests. a decision emerged after many hours of informal consultation at the who executive board in february, , on the next steps for global governance of harmful use of alcohol. clear evidence of increased alcohol consumption and attributable harm in many low-income and middleincome countries (lmics), and predictions of more harm to come if effective policy is not adopted, led a group of representatives from lmics to propose a working group "to review and propose the feasibility of developing an international instrument for alcohol control". the outcome of the executive board discussion illustrates the difficulty that alcohol control advocates face in the global governance environment; it is a compromise that might do more harm than good. the call for a working party to investigate an international control mechanism is not part of the final decision. instead there is a decision to develop an action plan ( - ) "to effectively implement the global strategy to reduce the harmful use of alcohol as a public health priority" and for a review of the global strategy by . this outcome gives the transnational alcohol corporations another years to expand their markets in lmics with emerging economies, the very countries that have been calling for investigation of a health treaty on alcohol, similar to that on tobacco, for several years. in these next years, the alcohol industry will benefit from the existing and future economic agreements, the effect of which is to chill the uptake of alcohol policies. without a framework convention, industry is expected to continue its unregulated marketing in the digital world, using big data to identify and target potential and current alcohol users, and increase profits. lobbying by industry and associated stakeholders is likely to prevent the uptake of effective policy. if we are to prevent the increase in alcohol-attributable harm in the emerging markets, the global health community needs to support national health sectors to protect abstention and reduce the extent to which alcohol is consumed in heavy drinking occasions. we need analysis to develop the content of an international control mechanism to support national governments and attract funding as the who framework convention on tobacco control (fctc) has done. , in this context, we question the executive board decision. how can the governing body of an evidence-based health-protection organisation not investigate the feasibility of an international response that is so clearly needed? perhaps the answer lies in the alcohol blind spot, a failure to respond to alcohol harm by the global health community, and behind that the profits made by the alcohol transnational corporations. industry-funded organisations were engaged in the lead-up to the executive board discussion. engaging america's global leadership argued: "the global strategy has so far been effective and should remain the leading international policy instrument to reduce harmful drinking...despite the constructive progress that has been made, who eb documents have instead started to emphasize that reducing alcohol consumption is an unmet goal, pushing for members to adopt and expand the use of 'best buys' policies. these policies-tax increases on alcohol, restrictions on alcohol marketing, and limitations on the physical availability of retailed alcohol-have unverified track records and can cause serious unintended consequences." uk (ah-c); and school of government and international relations why the who needs a chief economist covid- : the gendered impacts of the outbreak mapping the margins: intersectionality, identity politics, and violence against women of color social determinants of health series the commercial determinants of health delivered by women, led by men: a gender and equity analysis of the global health and social workforce. geneva: world health organization gendered health systems: evidence from low-and middle-income countries feminism for the %: a manifesto international monetary fund. things you need to know about the imf and gender world bank group gender strategy (fy - ): gender equality, poverty reduction, and inclusive growth making gender equality a major global cause g brisbane commitments global healthcare policy and the austerity agenda globalization and health equity: the impact of structural adjustment programs on developing countries the world bank and gender equality the imf and gender equality: operationalising change lessons from sweden's feminist foreign policy for global health declaration and platform for action, adopted at the fourth world conference on women how women contribute $ trillion to global healthcare. the conversation addressing violence against women: a call to action how do gender relations affect the working lives of close to community health service providers? empirical research, a review and conceptual framework key: cord- - kgfwjzd authors: neo, jacqueline pei shan; tan, boon huan title: the use of animals as a surveillance tool for monitoring environmental health hazards, human health hazards and bioterrorism date: - - journal: veterinary microbiology doi: . /j.vetmic. . . sha: doc_id: cord_uid: kgfwjzd abstract this review discusses the utilization of wild or domestic animals as surveillance tools for monitoring naturally occurring environmental and human health hazards. besides providing early warning to natural hazards, animals can also provide early warning to societal hazards like bioterrorism. animals are ideal surveillance tools to humans because they share the same environment as humans and spend more time outdoors than humans, increasing their exposure risk. furthermore, the biologically compressed lifespans of some animals may allow them to develop clinical signs more rapidly after exposure to specific pathogens. animals are an excellent channel for monitoring novel and known pathogens with outbreak potential given that more than % of emerging infectious diseases in humans originate as zoonoses. this review attempts to highlight animal illnesses, deaths, biomarkers or sentinel events, to remind human and veterinary public health programs that animal health can be used to discover, monitor or predict environmental health hazards, human health hazards, or bioterrorism. lastly, we hope that this review will encourage the implementation of animals as a surveillance tool by clinicians, veterinarians, ecosystem health professionals, researchers and governments. zoonosis is derived from the greek words "zoon" (animals) and "nosos" (disease), referring to any infectious diseases transmitted from animals to humans, either directly or indirectly (world health organization, ) . as the global human population increases, so will anthropogenic pressures on wildlife and the environment, augmenting the likelihood of zoonotic pathogen spillover from animal to human populations. the world health organization (who) identifies zoonoses as emerging threats and describe them as previously occurring phenomena that have an increasing trend and expansion in geographical, host or vector range. more than % of all emerging infectious diseases are from zoonoses (mackenzie and jeggo, ) . despite acting as the main reservoir for only % of the known zoonoses, humans are the main source of identification for disease outbreaks (frank, ) . as such, epidemiological relationships agents in an analogous manner to humans and manifest similar disease symptoms. some animals have biologically compressed lifespans, consequently developing clinical signs more rapidly after exposure to specific pathogens. furthermore, they may be more susceptible to contaminants than humans and they do not share some human behaviors that may confound investigation results (e.g. smoking). table provides a list of websites containing information related to the use of animals for surveillance. proper utilization of animals for surveillance may allow the early identification of epidemics, which facilitates mitigation of its magnitude, or prevention of its occurrence (chomel, ; kahn, ) . this is due to the ability of animals to: ) exhibit changes in the occurrence or prevalence of a pathogen or disease with time, ) serve as markers for on-going exposure risk, ) allow examination of hypotheses on the ecology of pathogens, and ) provide information on the efficiency of disease control measures (mccluskey, ) . this review attempts to highlight animal illnesses, deaths, biomarkers or sentinel events, to remind human and veterinary public health programs that animal health can be used to discover, monitor or predict environmental and human health hazards, or bioterrorism. animals useful for surveillance mostly exist in the environment as hosts of naturally cycling pathogens. they can be utilized in passive, active or sentinel surveillance programs. passive (reactive) surveillance involves the spontaneous reporting of disease data from the animal sector to veterinary authorities (hoinville et al., ) . data reported can include illnesses or deaths in animals, or notifiable diseases that must be reported by law. the data is then analyzed to observe disease trends and identify potential outbreaks. active (proactive) surveillance on the other hand involves calling on animal facilities to interview workers and to review animal health records to identify diseases under surveillance. it also involves actively monitoring domestic or wild animals for biomarkers. the choice of surveillance type depends on the characteristics of a pathogen and the objective of the program. passive surveillance is best employed when the objective of the program is targeted towards early detection of outbreaks or monitoring the extent of disease for making decisions on control strategies; whereas, active surveillance is best employed when a disease is targeted for elimination. passive surveillance is the least time consuming, labor intensive and expensive of the three forms of surveillance, and covers an extensive range. however, because it relies heavily on reports from veterinarians who receive little incentive for reporting, the data reported is frequently incomplete and delayed. underreporting of disease suspicions is also known to be a major cause of disease control failure (fao, ) and multiple studies have been conducted to better comprehend the decisionmaking processes behind underreporting so as to develop recommendations for improved passive surveillance (bronner et al., ; delabouglise et al., ; paul et al., ; sawford et al., ; thompson et al., ) . in contrast, active surveillance demands more time and resources and is thus less commonly employed. however, it provides more complete and accurate data than passive surveillance. a study comparing active and passive animal surveillance in chad concluded that for monitoring of existing diseases, the less expensive passive surveillance is better (marr and calisher, ) . historian plutarch mentioned that flock of ravens displayed unusual behavior and died subsequently as alexander entered babylon. several hundred livestock deaths death of several hundred livestock in lake alexandrina, australia allowed the identification of cyanobacteria nodularia spumigena in water. despite warnings issued, there was undescribed illness was reported in one individual after consuming contaminated water (codd et al., ) . th century canaries in coal mines coal miners in the u.k. and the u.s. brought canaries into coalmines as an early-warning signal for toxic gases including methane and carbon monoxide. the birds, being more sensitive, would become sick before the miners, who would then have a chance to escape or put on protective respirators (burrell and seibert, ). minamata disease cats from a fishing village, minamata developed a neurological disease. people of minamata later displayed similar symptoms. investigations later found that effluent from a factory had polluted surrounding waters resulting in accumulation of mercury in fish (takeuchi et al., (takeuchi et al., ). chicken sentinels chickens as sentinels for surveillance of arboviruses like wnv, wee and sle viruses (rainey et al., ) . rabbits warn of nerve gases during transportation rabbits were placed in small cages in railcars during transportation of nerve gases and sudden animal mortality would warn of gas release (brankowitz, ) . april sverdlovsky anthrax release anthrax was accidentally released from a soviet military microbiology facility. livestock died at a greater distance of km from the plant, compared to human cases which occurred within a narrow km zone downwind of the facility (meselson et al., ) . west nile virus wnv was reintroduced into the u.s., where it caused the ongoing epizootic in birds with a spillover of infections to humans and equines (chancey et al., ) . chickens on alert in kuwait u.s. marine corps employed chickens for the detection of nerve and blister agents. they were meant to act as a backup to false alarms the automated detectors were notorious for (ember, (ember, ). dog, livestock, wildlife deaths death of dogs, livestock and wildlife in the buccaneer bay lake, eastern nebraska, u.s. allowed identification of cyanobacteria anabaena, microcystis, oscillatoria and aphanizo-menon in water. > incidences of skin lesions, rash, gastroenteritis and/or headache were reported in humans. warnings were issued (walker et al., (walker et al., ). plague cases in yulong county of the yunnan province, china serologic survey found antibodies against the f antigen from domestic dogs around the affected county, demonstrating that domestic dogs could serve as animals for plague surveillance (li et al., ) . windblown lead carbonate in esperance, western australia windblown lead carbonate causing huge number of bird deaths in esperance, western australia, prevents lead exposure to esperance community (gulson et al., ). suited for chad's conditions. whereas, for monitoring of rare diseases, active surveillance of animal herds is required to complete passive surveillance (ouagal et al., ) . occasionally, when high-quality data about a specific disease is required, animal sentinels are intentionally deployed for surveillance. these animals receive greater attention than would be possible with active or passive surveillance. sentinel surveillance is less extensive in terms of range and personnel involved compared to passive surveillance, but often yields more detailed data. it is best employed when thorough investigation of each animal or site is necessary, however it may not be as effective for detecting diseases outside the demarcated limits of the sentinel sites. examples of events involving the various forms of animal surveillance spanning bce and the st century can be found in table . the review concludes with the one health approach. a sentinel is a naïve animal which is intentionally placed in an environment of potential infection that is monitored at short time intervals to detect infection. if the sentinel is deployed close to human populations, the sentinel should react to the infectious agent (but not become infectious), thereby providing early warning of human health hazards in the environment (van der schalie et al., ) . a classic example of an animal sentinel system is the well-known canary in the coalmine (burrell and seibert, ) . canaries are sensitive to the effects of poisonous gases, particularly carbon monoxide, and were routinely taken into the mines to warn of dangers. its inclination to sing much of the time, coupled with its brightly colored plumage offered both "audio and visual" cues to the miners. if the canary stopped singing and/or fell from its perch, this was the signal for the miners to don their respirators or evacuate. many miners owe their existence and livelihood to this historic animal sentinel. besides canaries, other animal species have also been used as sentinels of toxic chemical exposure. for example, birds, horses, cats, guinea pigs, rats, mice and rabbits were employed as sentinels for chemical agent exposure during world war i (wwi) and wwii. until , rabbits were placed in small cages in railcars during the transportation of nerve gases and sudden animal mortality would warn of gas release (brankowitz, ) . although technological advancements have since resulted in the more widespread use of electronic detectors for detecting toxic chemicals, animal sentinels are still superior because of the complexity and likeness of the animal and human physiology. this is evidenced by more recent uses of animals, in particular avian species, as sentinels of toxic chemical exposure. for example, on march , , the tokyo underground trains were hit by synchronized chemical terrorist attacks (national research council of the national academies, ). the aum shinrikyo religious sect dispensed a concoction of military nerve agent, sarin, killing twelve and injuring thousands. as a precaution, the japanese policemen carried canaries À the very primitive animal sentinel À in cages with them to warn of the presence of toxic gases during raids. another recent example of the use of avian species as sentinels of toxic chemical exposures was in , when u.s. marine corps employed chicken sentinels at the kuwaiti staging area despite the deployment of automated detectors (ember, ) . the chickens were employed to complement the m ionmobility spectrometer, which was used to tag nerve and blister agents. they were meant to act as a backup to false alarms the automated detectors were notorious for. other than as sentinels of toxic chemical exposure, the avian species has also proven itself to be a valuable sentinel of disease outbreaks. for example, chickens have been used as sentinels for the surveillance of arboviruses like west nile virus (wnv), western equine encephalomyelitis (wee) and st. louis encephalitis (sle) viruses (moore et al., ) . they are amenable to and can tolerate arboviral infections with little or no symptoms, developing antibodies within a week of being bitten by an infected mosquito. they produce low tittered viremia, are cheap to purchase, robust and easily bled (biweekly or monthly during the peak season from june to october), making them excellent sentinel animals of arboviruses. despite providing accurate spatiotemporal information on virus transmission, the relationship between mosquito transmission and percentage of bird and mosquito infections in a particular region still needs to be determined in order to precisely evaluate human risk. in order to improve their use as sentinels, chicken interferon-a can be administered perorally in drinking water, where it acts as an adjuvant, inducing rapid seroconversion in chickens after infection by low pathogenic avian influenza (lpai). these chickens are called 'super-sentinels' since they are able to detect clinically inapparent lpai (marcus et al., ) . lpai strains are the most widespread, and can mutate into highly pathogenic avian influenza (hpai) strains, which can lead to human transmission and potential fatalities. thus, by placing super-sentinel chickens in locations prone to bird flu outbreaks, for example live-bird markets, this would allow early detection of lpai, thereby buying time for its control. in spite of the value of animal sentinels in monitoring the presence of pathogens or chemicals in the surroundings, there are ethical concerns regarding the deliberate exposure of animals to danger by placing them at sites of suspected contamination. consequently, the surveillance of extant animals in their natural habitats could act as an alternative means to warn of human, veterinary or environmental health hazards. animals in many habitats can be studied to monitor health hazards in the environment (reif, ) . environmental health hazards refer to both natural and unnatural contaminants in air, water, soil or food, which can potentially lead to acute or chronic health issues in humans (national research council (u.s.) and committee on animals as monitors of environmental hazards, ) . a variety of marine species are excellent surveillance tools of environmental stress and potential health threats for humans. for example, the mussel watch program actively analyzes sediment and bivalve tissue chemistry for a suite of organic contaminants and trace metals to identify trends at over selected u.s. coastal sites from to today. it is designed to identify deleterious changes in the marine habitat and indicate potential human health concerns (kim et al., ) . anomalocardia brasiliana is also a good surveillance tool for actively monitoring contamination levels of coliforms in shellfish harvesting regions in brazil's northeast coast (lima-filho et al., ) . mussels, clams and oysters are particularly suitable for us as surveillance tools because they are able to bioaccumulate many chemicals (o'connor and lauenstein, ) , as well as concentrate microbial organisms and pathogens (kueh and chan, ) to concentrations in excess of fold (grodzki et al., ) . thus, the high concentrations of chemical and pathogens make it easier to detect environmental and health threats in these organisms. moreover, improved sequencing technologies have led to the monitoring of bivalves via genomics, epigenomics, transcriptomics, proteomics and metabolomics (suarez-ulloa et al., ) . such integrative omic studies will make powerful tools in the biomonitoring of marine pollution. besides marine species, cats can be potentially used as a passive surveillance tool for monitoring toxic chemicals in the aquatic ecosystem. in , japanese veterinarians discovered a neurological disease in cats in the minamata fishing village (takeuchi et al., ) . it was called "dancing cat fever" because the cats displayed convulsions and involuntary jumping movements. however, this disease was not investigated rigorously until similar symptoms also manifested in the people of minamata. as a result of subsequent epidemiologic studies in minamata, researchers realised that effluent from a factory had polluted surrounding waters resulting in the accumulation of mercury in fish. subsequent consumption of contaminated fish by fishermen and their families resulted in high mercury concentrations in their brains, kidneys and livers. had the authorities paid more attention to the cats' disease symptoms, this could have been prevented. nevertheless, this episode raised the awareness of cats as a surveillance tool for monitoring mercury poisoning, food safety and public health throughout the world. besides mercury poisoning, there have been increasing numbers of reports of human or animal illnesses or deaths associated with harmful cyanobacteria blooms in freshwater systems. hence, in a similar way, the surveillance of fish, dogs or livestock can provide important early warnings of cyanobacteria-associated environmental hazards (hilborn and beasley, ) . more recently in , the "birds dropping from the sky" phenomenon demonstrated how passive monitoring of bird dieoffs alerted the community of esperance, western australia to a case of lead poisoning in the environment (gulson et al., ) . during that period, the community was alarmed by the sudden death of more than birds. this sparked an urgent investigation which eventually revealed that the birds had died of lead poisoning. the lead ore concentrate had originated from the handling of lead carbonate concentrate at the megallan mine km north of esperance. the western australia department of health and local shire council measured lead concentrations in rainwater from household tanks (the main source of drinking water) and discovered that % of households had lead concentrations exceeding who guidelines of mg/l. although the death of numerous native bird species was tragic, it triggered the investigation, which ultimately prevented the catastrophic exposure of lead to the community. the clear and present dangers of emerging infectious diseases have propelled world governments to enhance animal surveillance activities (gubernot et al., ) . due to the zoonotic origin of most human health hazards, it is thought that animals may have a greater susceptibility to zoonotic pathogens, thereby justifying their use as surveillance tools for monitoring human health hazards. for example, in , death and illness in multiple avian species aided investigators in identifying wnv as the root of the encephalitis outbreak in humans in new york. during those periods, the unusually high numbers of encephalitis cases in humans was concurrent with a surge in dying crows with neurological symptoms similar to encephalitis patients (eidson et al., ) . this prompted investigations, which identified wnv as the cause of the outbreak, and demarcated its geographical limits since the crows were amplification hosts for viral transmission. the cdc, u.s. geological survey national wildlife health centre and u.s. department of agriculture have since been involved in the battle against wnv. strategies are currently in place to consolidate data on human, mosquito, bird, chicken and veterinary cases of west nile infection in the arbonet system (u.s. geological survey and cdc, ). other than birds, dogs could also act as surveillance tools for monitoring wnv circulation. seroconversion was detected in juvenile dogs weeks before wnv appeared in humans in houston, texas (resnick et al., ) . hence, active surveillance of wnv seroprevalence in birds and dogs can be used for monitoring wnv activity. additionally, the active surveillance of swine and live bird markets or supply abattoirs at the human-animal interface could be used to monitor the risk of hpai to human and animal populations. in and , the h n swine flu pandemic claimed more than , lives. this new strain resulted when a triple reassortment of northern american swine, bird and human flu viruses further combined with a eurasian pig flu virus (trifonov et al., ) . also in was the h n avian influenza outbreak which led to the intense surveillance of wild ducks for avian flu viruses in europe (globig et al., ) . in eastern asia, wild swans are an ideal surveillance species as there is vast geographical overlap between whooper swan distributions and h n outbreak areas (newman et al., ) . other hosts of hpai include cats and dogs (cleaveland et al., ; kuiken et al., ) . these studies show that active surveillance of suitable animal species through serosurveys could provide early warnings of hpai foci, accelerating public health investigation and action. bats are also important animals from a surveillance perspective. they have long life spans, are highly mobile and are increasingly well adapted to human environments due to habitat loss as a result of land use changes. they live in close proximity to humans, and interact with livestock and domestic animals that are potential intermediate hosts for pathogens. bats are the natural reservoir of severe acute respiratory syndrome coronavirus (sars-cov) (lau et al., ; li et al., ) , which was responsible for the sars-cov outbreak in , with known infected cases and confirmed human deaths worldwide (who, ) . besides sars-cov, bats are also reservoir hosts to filoviruses like ebola (leroy et al., ) and marburg (towner et al., ) viruses; paramyxoviruses like hendra (halpin et al., ) and nipah (yob et al., ) viruses; rubulaviruses like tioman (chua et al., ) and menangle (philbey et al., ) viruses; and the australian fruit bat lyssavirus (fraser et al., ) . there are however various challenges associated with the active surveillance of bats. firstly, the collection of blood and fluid samples from bats is dangerous given their highly infectious nature. secondly, the collection of bat specimens is difficult in remote areas. thirdly, bats are sensitive to disturbances and may migrate as a consequence of investigations, making it difficult to locate bat colonies. hotspots with high human and bat population density have thus been identified to focus bat surveillance efforts on areas with the highest probability of the emergence of zoonoses (jones et al., ) . dromedaries may also be potentially useful as surveillance tools. in particular, active surveillance of dromedaries in herds and large abattoirs could potentially reveal the prevalence of middle east respiratory syndrome coronavirus (mers-cov) infection. in , mers-cov was first detected in humans in saudi arabia. sera from dromedary camels across and beyond the arabian peninsula were found to harbor high levels of antibodies against mers-cov (reusken et al., ) . indeed, viral sequencing revealed nucleotide polymorphism signatures, indicative of cross-species transmission (chu et al., ; memish et al., ) . this suggests that human mers-cov infections could have been zoonotically acquired from camels and that their surveillance could reveal mers-cov foci. mosquitoes, aedes aegypti and potentially aedes albopictus, transmit brazilian zika virus (zikv) among humans. in , the first zikv infection was confirmed, and within a few months it was declared by the who to be a public health emergency of international concern (aziz et al., ) . health authorities have found zikv disease to be associated with auto-immune and neurological complications, and microcephaly in babies. transmission has been rampant in various regions and zikv is expected to spread to new territories. hence, the active surveillance of mosquitoes could enable the evaluation of vector control measures to determine the efficacy of zikv outbreak interventions. bioterrorism is the intentional release of microorganisms or biological agents to cause disease or death in humans, animals or plants to influence government conduct or threaten civilian population (cdc, ) . since more than % of bioweapons are zoonoses, animals are likely to be at high risk (ryan, ) and thus the surveillance of animals may provide early warning of a bioterrorist attack (rabinowitz et al., ) . farm animals like sheep and cows are potentially valuable surveillance tools for passively monitoring the production or release of bioterrorism weapons in rural areas. bacillus anthracis, the causative agent of anthrax, which has fatality rates of near % in both humans and animals, has been identified by cdc as one of the most likely biological agents to be used (cdc, ) . moreover, anthrax can form resilient spores that persist for decades in soil. during wwii, the british government was experimenting the use of anthrax on gruinard island. despite efforts to decontaminate the island, the long-lasting contamination of the soil by anthrax spores put the island under quarantine for years before it was considered safe for human use ("britain's anthrax island," ) . this highlights the importance of passively monitoring random cases in animals to identify anthrax hot spots. in , b. anthracis spores were inadvertently released from a soviet military microbiology facility in sverdlovsky (meselson et al., ) . livestock km away from the plant died, whereas human cases occurred within km downwind of the facility. analysis showed that the dosage of b. anthracis at which sheep and cows became ill was more than an order of magnitude lower than the dosage required to affect humans. this analysis therefore suggests that livestock are much more susceptible than humans to b. anthracis and would be ideal for use as surveillance tools for b. anthracis since lower dosages at greater distances from the source were sufficient to affect the animals. furthermore, animals like domestic dogs and rodents spend more time outdoors and have greater exposure to the environment than humans, making them great surveillance tools for monitoring plague. yersinia pestis, the etiological agent of plague, has also been identified by cdc as a bioterrorism agent (cdc, ) . it appeared in humans in the u.s. in the s (link, ; lipson, ) , and became established enzootically in wild rodents by the mid- s. it is hypothesized that plague is maintained by reservoir species like rodents, and that carnivores become ill following the ingestion of plague-infected rodents. in , plague cases were confirmed in the yulong county of the yunnan province, china (li et al., ) . a survey of serum samples of domestic dogs in and around the affected county confirmed that they could be used for active plague surveillance. the dynamics of infectious diseases are highly variable. they are determined by infecting dose, pathogen characteristics, host susceptibility and transmission routes. it is therefore important to have a framework for the proper evaluation of animals to determine if they are suitable for use as sentinels for surveillance. to this end, the halliday et al. ( ) conceptual framework effectively evaluates animals as sentinel populations for various surveillance aims and ecological settings (halliday et al., ) . there are three fundamental components of the sentinel framework: the pathogen under surveillance, the target population, and the sentinel population. the sentinel framework produces a sentinel response which could take the form of seroconversion, current infection, morbidity, mortality and changes in morphology or behavior. in addition to the sentinel response, other sentinel practical factors and host factors also influence the detectability of the sentinel response, which eventually determines the utility of the sentinel. as alluded to earlier, although there are numerous benefits in using animal sentinels, its use is associated with ethical concerns which might be alleviated by the surveillance of existing animals in their natural habitats. in spite of the obvious potential of animals as a surveillance tool for monitoring environmental damage, risks to human health and bioterrorism, animals currently appear to be underutilized as surveillance tools. a likely reason is that human and animal health surveillance efforts mostly stem from disparate initiatives, resulting in data being kept in entirely separate databases (scotch et al., ) . there is thus an increasing need for interdisciplinary integration between human and veterinary medicine, and communication before we can completely exploit the benefits of animals for surveillance (bisdorff et al., ; wendt et al., ) . to this end, committees have been established to increase awareness of the mutual reliance between human, animal, plant, microbial, and ecosystem health (rabinowitz et al., ) . this includes the 'one medicine' or 'one health' initiatives like the one health commission, the one health initiative and the comparative clinical science foundation (zinsstag et al., ) . the term 'one medicine' was coined in by calvin w. schwabe in recognition of the mutualism of human and animal health, nutrition and livelihood (schwabe, ) . this mutualism is further supported by the close genomic relationship of humans and animals (peters et al., ) . today, the appreciation of the interdependence of the well-being and health of humans, animals and the ecosystems, evolved the term 'one medicine' towards 'one health', to include public health, ecology and broader societal dimensions (zinsstag et al., ) . in support of one health, predict was launched in (usaid, a). the predict project is part of united states agency for international development's (usaid's) emerging pandemic threats (ept) program, designed to identify zoonotic viral threats with pandemic potential at wildlife-human viral transmission interfaces (kelly et al., ) . it has successfully improved surveillance and laboratory capabilities for monitoring humans (that have had animal contact) and wildlife for new and known pathogens with outbreak potential; defined ecological and human causes of zoonosis; and reinforced and perfected models for predicting outbreaks. it became the largest zoonotic virus surveillance project worldwide, successfully identifying and predicting the emergence of pathogens from wildlife. it also established infrastructure and expertise required for the operation of pandemic threat surveillance and diagnostics to support the one health workforce (ohw). the huge success of ept led to the launch of ept which aims to discover diseases of known and unknown origin; minimize the possibility of disease outbreaks by reducing human activities that promote disease spillover; boost national readiness; and ultimately to reduce the repercussions of novel zoonotic pathogen emergence (usaid, b). in southeast asia, there is the one health network south east asia platform supported by the european union to promote collaboration, networking and sharing between southeast asian one health programs (massey university new zealand, ). it presently hosts two programs, lacanet and comacross. lacanet is a cambodia and laos effort aimed at improving detection of zoonotic diseases, developing capabilities for surveillance, promoting regional and national collaborations, and researching into land-use change and wildlife trade À the two main causes of disease emergence. on the other hand, comacross is a thailand, cambodia and laos effort aimed at assembling a multidisciplinary framework to address complex one health problems and to improve integration between public health, animal health, agriculture and livestock, ecology, environmental science, social science and engineering. besides the one health network south east asia platform, in southeast asia, there is also biodivhealthsea supported by the french anr cp&es. it investigates the impact of global changes and global governance on zoonotic diseases, biodiversity and health (morand et al., ) . together with comacross, biodivhealthsea and a few other bodies have proposed in a southeast asian interdisciplinary conference that ecosystems could reveal potentially harmful developments for human health (walther et al., ) . they made recommendations for the implementation of the one health approach; future research direction; education, training, and capacity building; potential science-policy interactions; and ethical and legal considerations. these recommendations should influence legislation and enforcement, thereby strengthening the health and resilience of southeast asian societies. as typical with large programs, ept, ept , lacanet, comacross and biodivhealthsea will need to apportion sufficient funds and resources for conducting surveillance, laboratory diagnosis, consumables, equipment and infrastructure. it is therefore critical that they continue to collaborate with partners like the cdc, who, ohw, food and agriculture of the united nations, institut pasteur du cambodge and lao-oxford-mahosot hospital-wellcome trust research unit, to strengthen their capacity in surveillance and laboratory capabilities, and to ensure that efforts are not replicated. it is also important that one health programs continue to receive the support and funds that they need to sustain their work. the extent of support for animal disease surveillance in communities is largely built upon its understanding of the dangers of zoonoses to human health, trade and the economy, rather than out of interest in wildlife health. accordingly, it is crucial to boost public awareness of the importance of wildlife health to societies. lastly, governments are occasionally unwilling to announce potential disease outbreaks for various reasons, including preventing the disruption of trade. hence, it is important that reporting of wildlife diseases be standardized and made necessary, and for a reporting global clearinghouse to be established. altogether, 'one health' is a unifying paradigm encouraging integration and leverage of existing capabilities among clinicians, veterinarians, ecosystem health professionals, researchers and governments. ultimately, this will hopefully lead to the development and application of sustainable and effective community health interventions, thereby reducing zoonotic disease emergence, outbreaks and repercussions, and addressing some of the biggest multidisciplinary challenges of the st century. none. zika virus: global health challenge, threat and current situation active animal health surveillance in european union member states: gaps and opportunities chemical weapons movement history compilation. office of the program manager for chemical munitions (demilitarization and binary britain's anthrax island why do farmers and veterinarians not report all bovine abortions, as requested by the clinical brucellosis surveillance system in france? experiments with small animals and carbon monoxide bioterrorism overview [www document bioterrorism agents/diseases [www document the global ecology and epidemiology of west nile virus control 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health and well-being the writing of this review was supported by dso national laboratories. key: cord- -z anp h authors: muennig, peter; mcewen, bruce; belsky, daniel w.; noble, kimberly g.; riccio, james; manly, jennifer title: determining the optimal outcome measures for studying the social determinants of health date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: z anp h americans have significantly poorer health outcomes and shorter longevity than citizens of other industrialized nations. poverty is a major driver of these poor health outcomes in the united states. innovative anti-poverty policies may help reduce economic malaise thereby increasing the health and longevity of the most vulnerable americans. however, there is no consensus framework for studying the health impacts of anti-poverty social policies. in this paper, we describe a case study in which leading global experts systematically: ( ) developed a conceptual model that outlines the potential pathways through which a social policy influences health, ( ) fits outcome measures to this conceptual model, and ( ) estimates an optimal time frame for collection of the selected outcome measures. this systematic process, called the delphi method, has the potential to produce estimates more quickly and with less bias than might be achieved through expert panel discussions alone. our case study is a multi-component randomized-controlled trial (rct) of a workforce policy called mygoals for healthy aging. aristotle postulated that the social environment is an important determinant of human health [ ] . in the mid-nineteenth century, rudolf virchow conducted the first epidemiologic investigation showing the relationship between social conditions and health, documenting what would later come to be known as the "social determinants of health" [ , ] . the th century saw social policy and health policy begin to converge in europe and latin america [ , ] , with the world health organization formally recognizing the social determinants of health as "the conditions in which people are born, grow, live, work and age" [ ] . the affordable care act in the united states led to billions of dollars spent on the social determinants of health in the hope of preventing disease before it occurs [ , ] . one way to address the social determinants of health is to make investments in proven social policies in an attempt to improve the social circumstances of low-income families and individuals [ ] . were it possible to make even a small dent in the burden of disease associated with poverty, enormous gains in health and longevity could be realized [ ] . unfortunately, very few experimental tests of social policies have been conducted [ ] , and fewer still contain health outcomes [ ] [ ] [ ] . only three randomized-controlled trials (rcts) to date have attempted to collect objective biological measures of health using laboratory or medical examination data [ ] [ ] [ ] [ ] . this is in part because there is a good deal of uncertainty surrounding which measures to use [ , ] . this uncertainty arises from three challenges. first, the process of biological "wear and tear" associated with living in poverty begins from the time of conception [ , ] , but most anti-poverty programs are targeted toward older children and adults [ ] . as a result, it is necessary to devise a sensitive measure of health-a "yardstick"-that will change within the time frame of the study. a second challenge is that there is a latency between the time that one is exposed to a social policy and the point at which measurable changes in health occur [ ] . while income support programs can immediately lift a family out of poverty, it takes time for that family to invest the money in healthy food, housing, and health care. even after these investments are made, the effects of these investments take time to manifest as measurable changes in health [ ] . a third challenge lies in the nature of the available objective biomarkers of chronic disease [ ] . these can be difficult to collect, are sometimes statistically noisy, and may have an inadequate empirical base linking the measure to tangible health outcomes in humans. they also must be conceptually aligned with the expected mechanisms through which a given social policy influences health. what is needed is a sensitive but broad biological measure that can serve as a yardstick of changes in health over a relatively short period of time. in the absence of such a measure, those who study the effect of social policy on health face an enigma. how should we operationalize what the intervention does vis-à-vis changes in human physiology, and how do we know how far in the future we need to measure these changes given the nature of the intervention? this question is underscored by a recent meta-analysis of experimental social policy rcts, which found that most lacked adequate statistical power to detect a change in the outcome of interest [ ] . had a sensitive measure been available, the statistical power would have been higher. the authors set out to build a conceptual model for an ambitious social policy experiment called mygoals for healthy aging. prior to the exercise, each expert submitted their own conceptual model and relevant outcome measures anonymously. we were surprised to find that each expert in the room had a very different idea about how the intervention might influence health, and how to measure the changes in health that might arise from the intervention. in this paper, we describe our journey toward coming to a consensus about the correct way to measure health outcomes for this health policy experiment. given that a very long time must pass between changes in one's social circumstances and distal disease outcomes (like heart disease), measure selection is limited to outcomes than can reasonably change over a short period. these might include psychological stress, mental health, and biological measures of disease risk ("biomarkers"). biomarkers can include blood assays, such as cholesterol levels, or medical examination data, such as blood pressure. biomarkers are appealing endpoints for social policy rcts because they are objective, they have established links to disease, and they change over a relatively short period [ , ] . however, biomarkers must be selected carefully. the challenge is to match the biomarkers to the intervention of interest [ , ] . one approach to rule-in or rule-out a large number of candidate biomarkers is to build a team of experts, often backed up by research staff, to compile and summarize the existing literature. the stress measurement working group [ , ] and the targeting aging with metformin (tame) [ ] provide two examples of this approach. the stress measurement working group was tasked with selecting measures for several social surveys of aging populations, the health and retirement study in the united states, the english longitudinal study of ageing in england, and the survey of health, ageing and retirement in europe [ ] . the tame rct is designed to investigate whether a drug can slow human aging. social policy experiments are thought to affect health in a way that is very similar to this drug from a biological standpoint-they alter a cascade of biological events that lead to "wear and tear" on the body's physiological systems [ ] . this process (which we might call the "quantitative shotgun approach") can be very resource intensive, as a good deal of background work must be done to decide how to include or exclude measures, to conduct an extensive literature review, and to manage the information produced by experts over many months of meetings [ , ] . beyond these logistical challenges, there is also a need to manage bias. the bandwidth of leading experts can be limited, so they might not have the time to read literature that falls outside of their specific area of expertise (which can sometimes be limited to a single biomarker or biological pathway). open discussions can result in senior, charismatic, or otherwise forceful experts overpowering the ideas of those who are less expressive or who fear professional repercussions of disagreeing with their colleagues [ ] . an alternative to the quantitative shotgun approach is the delphi method. the delphi method also leverages expertise from multiple researchers to identify a consensus on a set of measures. it also uses introductory materials and research as a foundation upon which experts make decisions. however, it has a specific structure designed to overcome some limitations of the quantitative shotgun approach. one advantage is that it is highly structured, thereby reducing tangential discussions [ ] . the delphi method is led by a moderator, and can effectively be conducted over the phone or by email [ ] . a much bigger advantage is that key parts of the process are anonymized, so that the ideas of senior researchers are less likely to dominate the discussion. deciding which "experts" to select for a given delphi process really depends on one's overarching objectives [ ] . if the objective is to obtain a collective guess at a parameter in particle physics, then one would draw experts from a very narrow area of physics. however, if one's objective is to guess at the number of years needed before a given country developed a nuclear bomb, one may wish to draw not just from atomic scientists, but also experts on national security and possibly even anthropologists. thus, experts might be selected from a very narrow field, more broadly across a given field, or across a broad array of disciplines. after an initial briefing that includes an overview of the delphi method and the problem to be solved, a moderator guides experts through various "rounds" or iterations of the estimate to be obtained ( figure ). the result is incrementally modified over several sessions. this iterative process allows experts to quickly identify problems in logical thinking or missing information as they constantly reformulate their ideas, ideally arriving at a consensus. obtained ( figure ). the result is incrementally modified over several sessions. this iterative process allows experts to quickly identify problems in logical thinking or missing information as they constantly reformulate their ideas, ideally arriving at a consensus. in the delphi method, experts anonymously discuss a problem over various rounds, with each round, the estimate is refined until consensus or near consensus is reached. our case study outlines this process for a unique rct called mygoals for healthy aging, which is a piggyback health study on an innovative welfare intervention called mygoals for employment success [ ] . the parent intervention assigned , unemployed recipients of government housing subsidies (section voucher or public housing) to mygoals (the treatment group) or to a control group that did not have access to mygoals. the treatment group is offered three years of employment coaching that uses an explicit methodology for helping participants set and achieve goals across four domains (employment, education/training, financial management, and personal and family wellbeing) with an explicit focus on identifying and addressing "executive function" challenges that get in the way of goal-achievement in these domains [ ] . this coaching is coupled with a package of cash payments that includes a monthly stipend for engaging in substantive coaching sessions plus incentives for achieving certain employment outcomes. executive function refers to the selfregulation capacities that are essential for successful execution of tasks and include such cognitive skills as stress tolerance, emotional control, time management, metacognition, mental flexibility, task initiation, sustained attention, and others [ − ] . if mygoals increases participants' earnings and fringe benefits, that increased compensation combined with the financial incentives (which are disregarded in government transfer benefit calculations) and benefits associated with employment, such as the earned income tax credit and, in our case, funding for the coronavirus aid, relief, and economic security (cares) act, will improve participants' net disposable income and reduce their likelihood of being poor or the extent of their poverty relative to the control group. (these benefits arise because the participant is more likely to be employed and therefore filing taxes.) we first contacted a number of other investigators of social policy rcts to ask how they had selected measures in their previous studies. standard practice, we learned, is to simply query experts, who then provide input as to a range of survey, medical examination, and blood measures to fit the conceptual model of the intervention [ ] . the initial conceptual model for mygoals for healthy aging ( figure ) was simply drawn out by a handful of experts in the social determinants of health. measures were then selected for each component of the model and tested to statistical power to determine whether they were feasible. this model was included in a grant to the national institute on aging, but reviewers disliked the structure and raised questions about the measures we collected as well as the timing of measure collection. our team was awarded funding to refine the structure, and we decided to deploy the delphi method to address these reviewer concerns. in the delphi method, experts anonymously discuss a problem over various rounds, with each round, the estimate is refined until consensus or near consensus is reached. our case study outlines this process for a unique rct called mygoals for healthy aging, which is a piggyback health study on an innovative welfare intervention called mygoals for employment success [ ] . the parent intervention assigned unemployed recipients of government housing subsidies (section voucher or public housing) to mygoals (the treatment group) or to a control group that did not have access to mygoals. the treatment group is offered three years of employment coaching that uses an explicit methodology for helping participants set and achieve goals across four domains (employment, education/training, financial management, and personal and family well-being) with an explicit focus on identifying and addressing "executive function" challenges that get in the way of goal-achievement in these domains [ ] . this coaching is coupled with a package of cash payments that includes a monthly stipend for engaging in substantive coaching sessions plus incentives for achieving certain employment outcomes. executive function refers to the self-regulation capacities that are essential for successful execution of tasks and include such cognitive skills as stress tolerance, emotional control, time management, metacognition, mental flexibility, task initiation, sustained attention, and others [ ] [ ] [ ] . if mygoals increases participants' earnings and fringe benefits, that increased compensation combined with the financial incentives (which are disregarded in government transfer benefit calculations) and benefits associated with employment, such as the earned income tax credit and, in our case, funding for the coronavirus aid, relief, and economic security (cares) act, will improve participants' net disposable income and reduce their likelihood of being poor or the extent of their poverty relative to the control group. (these benefits arise because the participant is more likely to be employed and therefore filing taxes.). we first contacted a number of other investigators of social policy rcts to ask how they had selected measures in their previous studies. standard practice, we learned, is to simply query experts, who then provide input as to a range of survey, medical examination, and blood measures to fit the conceptual model of the intervention [ ] . the initial conceptual model for mygoals for healthy aging (figure ) was simply drawn out by a handful of experts in the social determinants of health. measures were then selected for each component of the model and tested to statistical power to determine whether they were feasible. this model was included in a grant to the national institute on aging, but reviewers disliked the structure and raised questions about the measures we collected as well as the timing of measure collection. our team was awarded funding to refine the structure, and we decided to deploy the delphi method to address these reviewer concerns. int. j. environ. res. public health , , x for peer review of this increases income thereby reducing psychological stress [ ] . reductions in psychological stress influence physical and mental health via allostatic load [ ] while also producing synergies with the executive function training program to reduce neural damage and improve executive function, thereby improving work performance and behavioral risk factors [ , ] . here, executive function (e.g., the ability to plan and execute those plans) was separated from broader cognitive function to show how employment can enhance broader cognitive skillsets, such as math [ ] . the experts were carefully selected to ensure: ( ) comprehensive expertise in the domains of the intervention, ( ) the social determinants of health, and ( ) familiarity with social policy or experimental research designs. this required not only selecting interdisciplinary experts, but also those who had specifically applied their work across disciplines. the principal investigator and the national institute on aging program officer were both familiar with experts who met these characteristics. six experts were invited, but one could not attend in person, leaving a total of . the in addition to these experts, james riccio was present. dr. riccio, the pi for the parent mygoals demonstration, has led numerous multi-center social policy rcts and was therefore invaluable to the de-anonymized discussions as were other mdrc staff. experts were first distributed a -page description of the mygoals rct, including its sample size, locations, and details of the intervention. the description was followed by a task (sketching out figure . the conceptual model used prior to the delphi method. when this model underwent review in the national institute on aging, reviewers were concerned about the sequencing of events, and asked that it be revised. in this model, income is derived from incentive payments and employment. this increases income thereby reducing psychological stress [ ] . reductions in psychological stress influence physical and mental health via allostatic load [ ] while also producing synergies with the executive function training program to reduce neural damage and improve executive function, thereby improving work performance and behavioral risk factors [ , ] . here, executive function (e.g., the ability to plan and execute those plans) was separated from broader cognitive function to show how employment can enhance broader cognitive skillsets, such as math [ ] . the experts were carefully selected to ensure: ( ) comprehensive expertise in the domains of the intervention, ( ) the social determinants of health, and ( ) familiarity with social policy or experimental research designs. this required not only selecting interdisciplinary experts, but also those who had specifically applied their work across disciplines. the principal investigator and the national institute on aging program officer were both familiar with experts who met these characteristics. six experts were invited, but one could not attend in person, leaving a total of . the in addition to these experts, james riccio was present. dr. riccio, the pi for the parent mygoals demonstration, has led numerous multi-center social policy rcts and was therefore invaluable to the de-anonymized discussions as were other mdrc staff. experts were first distributed a -page description of the mygoals rct, including its sample size, locations, and details of the intervention. the description was followed by a task (sketching out the conceptual model), two quantitative questions, and another task (linking survey or biological outcome measures to each component of the conceptual model). prior to the meeting, the facilitator re-drew pen and paper images of each pathway presented by the participants to help preserve the anonymity of the participants and to provide consistency in the presentation. participants were brought together to an in-person, h meeting. mdrc staff reviewed the intervention and took questions that came up regarding the experiment. after this introduction, participants discussed the questions from the prior round. a majority opinion was reached among out of the participants during this round, even though the in-person meeting was not meant to develop a consensus. participants were contacted following the meeting and asked to anonymously confirm their individual responses. one participant disagreed with the results of the first round. the moderator relayed individual responses and concerns to this participant over additional rounds of email, and the final model was sent to the entire panel for a final vote. income is thought to be a key pathway. four out of five participants thought that income was important for health (one participant felt that income was the only important mediator in the pathway between intervention and health outcomes). three out of five thought that employment was important for health and an equal number thought that the executive function coaching was important for health. a range of biomarker measures are proposed as potential endpoints. with respect to outcomes, four out of five of the figures the experts submitted had depicted stress reduction as a mechanism through which mygoals for healthy aging would improve physical and mental health outcomes. three out of five recommended the perceived stress scale and an equal number recommended a biological measure of stress (blood pressure, hair cortisol, or c-reactive protein). three out of five thought that cognition (measured both using the behavior rating inventory of executive function (adult version) and tasks from the nih toolbox, a set of tests available from the national institutes of health) as well as mental health/well-being (measured using the patient health questionnaire and beck anxiety inventory) would be enhanced by the intervention. two participants thought that body-mass index (bmi) and blood pressure would be decreased and one thought that sleep would be improved. the pathways that all of the participants initially sketched out were sequential (e.g., income leads to reduced stress which then leads to increased sleep). for the second round, which was held face-to-face, the facilitator presented tabulated data from the first round of anonymous inputs. after this, each participant's anonymized conceptual model was reviewed in front of the group. a more in-depth discussion was then undertaken regarding each pathway. this portion of the discussion was for idea generation and was not anonymized. it was meant to exploit the power of free association within the group before returning to anonymized input. executive function coaching and health: evaluating potential mechanisms suggests new outcome measures. after the question and answer session, all participants agreed that executive function was important for health in theory, but most felt that the executive function coaching component of the intervention would only be beneficial for some participants. this led the participants to probe the mdrc staff regarding the nature of the intervention. participants were told that the coaches were trained to be supportive rather than prescriptive. that is, rather than saying, "i have the perfect job for you," they would ask, "are you interested in looking for a job?" they also learned that the coaches were from similar backgrounds as the participants (e.g., had also been recipients of public housing), and were provided an example that one participant had identified the coach as his only "real friend." they also learned that some participants sought additional coaching sessions for which they were not compensated. these factors led the experts to believe that having a "friendly face" with whom to talk about life's challenges would potentially have an impact on measures of stress, anxiety, and depression. it was therefore postulated that the coaching had both the effect of addressing some of the executive function deficits of some participants and also serving to provide social support for others. measures not identified at the outset of the process were raised as relevant, including sleep quality and perceived discrimination in the workforce. with respect to the latter, all participants came to the conclusion that employment could produce both positive and harmful effects. on the positive side, it affords new opportunities for cognitive engagement, development of social skills (e.g., with co-workers and customers), and to build social capital. on the other hand, participants felt that some aspects of all work, and low-wage work especially, tended to be stressful, and that exposing participants to the employment market would also expose them to discrimination (particularly if they are women or racial/ethnic minorities). occupational safety was brought up as a potential health hazard specific to being employed. timing and model building. a final issue concerned timing of outcome collection. all experts suggested the same general follow-up range: − years. therefore, this was not discussed in additional rounds. however, the experts pointed out that it is not possible to actually sequence these events in time, and that sequencing should not be built into the conceptual model ( figure ) . the group came to the conclusion that the best approach would be to consider the intervention to include executive function, a friendly face, income support, and employment. it was decided that the study should include a measure of stress, a measure of anxiety, a measure of depression, a measure of sleep, and a set of biomarker measures that reasonably serve as intermediate for stress, inflammation, and future disease. the experts argued for established measures that have been traditionally used in social determinants research rather than those that reflect newer research or ideas that might be more controversial for a nih review panel. for cognitive outcomes, it was felt that both validated survey instruments and data from tasks should be collected. the final rounds were conducted by email, with each participant providing their final vote. one participant disagreed with the other four with respect to the physiological measures. this expert expressed the desire to use hair cortisol and telomere length as outcome measures. the moderator and other experts then discussed these ideas by emails. concerns included: ) difficulty obtaining hair from bald people or women who are concerned about cosmetic changes [ ] , and ) concerns that cortisol levels will be suppressed in some people with chronic stress but elevated in others, leading to results that are difficult to interpret. at that point, participant agreed that hair collection would be an issue. this reviewer also suggested that a waist-to-hip ratio be obtained as a measure of obesity, noting recent evidence that body-mass index was an incomplete measure of obesity [ , ] . this participant also suggested a long-term measure of life trauma in order to better understand whether trauma altered participants' responses to the intervention [ ] . the final model appears in figure . sequencing, including all of the measured outcomes, and to consider enhancements to broader cognitive function as a part of the outcome, rather than part of the intervention (figure ). in addition, after learning about the experiences that the executive function coaches have had with the clients, the expert panel felt that part of the intervention entailed adding a "friendly face," or a friend to talk with about the participants' problems. ) measured using the three-item loneliness scale; ) measured using the insomnia severity index; ) measured using the beck anxiety inventory; ) measured using the patient health questionnaire ; ) measured using the perceived stress scale; ) blood pressure, c-reactive protein, interleukin- , hemoglobin a c; ) measured by trained examiner three times; ) measured using the eating at america's table survey; ) measured using questions taken from the behavioral risk factor surveillance system; ) measured height, weight, waist circumference, hip circumference, waist-tohip ratio; ) measured using the behavior rating inventory of executive function (brief) and the flanker + dimensional card sort tasks from nih toolbox; ) measured using the national death index. note: serum will be banked for possible future biomarker analyses such as conserved transcriptional response to adversity, gene x environment studies, biological clock studies, and metabolomic studies as these are rapidly evolving fields of study that will undoubtedly change over the period of performance of the grant. we demonstrate a process by which a conceptual model and outcome measures (along with other useful estimates, like timing for data collection) can be quickly accomplished via the use of expert input. while there is no counterfactual "ideal" against which the results of the delphi process can be compared, it is worthy to note that the experts produced a significant alteration to the way that the intervention was perceived to work, produced major alterations to the presentation of the conceptual model, and altered four of the original outcome measures. our model has now been incorporated into the research plan for mygoals for healthy aging, and it will be used to determine the selection and timing of the outcome measures if the study is funded by the national institute on aging. we also hope that our study will serve two uses for the greater scientific community. first, we hope that it will provide a foundation for thinking through the ways that social policies might impact health. second, we hope that it provides a scaffolding and method for the rapid and inexpensive development of future social policy research that includes health outcomes. funding: this study was funded with a grant from the national institute on aging r ag - a . the authors declare no conflict of interest. about the original model by removing temporal sequencing, including all of the measured outcomes, and to consider enhancements to broader cognitive function as a part of the outcome, rather than part of the intervention (figure ). in addition, after learning about the experiences that the executive function coaches have had with the clients, the expert panel felt that part of the intervention entailed adding a "friendly face," or a friend to talk with about the participants' problems. ( ) measured using the three-item loneliness scale; ( ) measured using the insomnia severity index; ( ) measured using the beck anxiety inventory; ( ) measured using the patient health questionnaire ; ( ) measured using the perceived stress scale; ( ) blood pressure, c-reactive protein, interleukin- , hemoglobin a c; ( ) measured by trained examiner three times; ( ) measured using the eating at america's table survey; ( ) measured using questions taken from the behavioral risk factor surveillance system; ( ) measured height, weight, waist circumference, hip circumference, waist-to-hip ratio; ( ) measured using the behavior rating inventory of executive function (brief) and the flanker + dimensional card sort tasks from nih toolbox; ( ) measured using the national death index. note: serum will be banked for possible future biomarker analyses such as conserved transcriptional response to adversity, gene x environment studies, biological clock studies, and metabolomic studies as these are rapidly evolving fields of study that will undoubtedly change over the period of performance of the grant. we demonstrate a process by which a conceptual model and outcome measures (along with other useful estimates, like timing for data collection) can be quickly accomplished via the use of expert input. while there is no counterfactual "ideal" against which the results of the delphi process can be compared, it is worthy to note that the experts produced a significant alteration to the way that the intervention was perceived to work, produced major alterations to the presentation of the conceptual model, and altered four of the original outcome measures. our model has now been incorporated into the research plan for mygoals for healthy aging, and it will be used to determine the selection and timing of the outcome measures if the study is funded by the national institute on aging. we also hope that our study will serve two uses for the greater scientific community. first, we hope that it will provide a foundation for thinking through the ways that social policies might impact health. second, we hope that it provides a scaffolding and method for the rapid and inexpensive development of future social policy research that includes health outcomes. the historical origins of the basic concepts of health promotion and education: the role of ancient greek philosophy and medicine notes on the typhoid epidemic prevailing in upper silesia closing the gap in a generation: health equity through action on the social determinants of health: commission on social determinants of health final report; world health organization inequalities in health. the black report: a summary and comment medicine, socialism, and totalitarianism: lessons from chile the delivery system reform incentive payment (dsrip) program beyond a traditional payer-cms's role in improving population health us health in international perspective: shorter lives, poorer health the income-associated burden of disease in the united states show me the evidence: obama's fight for rigor and results in social policy money, schooling, and health: mechanisms and causal evidence national research council; commission on behavioral and social sciences and education. biosocial opportunities for surveys can social policies improve health? a systematic review and meta-analysis of randomized trials neighborhood effects on the long-term well-being of low-income adults early childhood investments substantially boost adult health the oregon experiment-effects of medicaid on clinical outcomes elastic powers: the integration of biomarkers into the health and retirement study health disparities across the lifespan: meaning, methods, and mechanisms health selection vs. causation in the income gradient: what can we learn from graphical trends? j. health care poor underserved the effect of small class sizes on mortality through age years: evidence from a multicenter randomized controlled trial a framework for selection of blood-based biomarkers for geroscience-guided clinical trials: report from the tame allostatic load as a marker of cumulative biological risk: macarthur studies of successful aging socioeconomic status and health in industrial nations: social, psychological and biological pathways the benefits and challenges of collecting physical measures and biomarkers in cross-national studies measures of stress in the health and retirement survey (hrs) and the hrs family of studies protective and damaging effects of stress mediators how expert are the experts? an exploration of the concept of 'expert' within delphi panel techniques mygoals for employment success a manual for executive skills coaching with adults affected by conditions of poverty and stress socioeconomic status and executive function: developmental trajectories and mediation participation in work: the necessity of addressing executive function deficits executive function moderates the intention-behavior link for physical activity and dietary behavior anonymized personal communication socioeconomic status is associated with stress hormones income and psychological distress: the role of the social environment history of socioeconomic disadvantage and allostatic load in later life socio-economic differentials in peripheral biology: cumulative allostatic load mcewen was a mentor and hero to us all. he helped us see the invisible world linking our day-to-day experiences to how our bodies and minds thrive and remain healthy. he passed away weeks after making his final contribution to this manuscript and will be dearly missed. the authors declare no conflict of interest. int. j. environ. res. public health , , key: cord- -qtfx qp authors: scott, jodie; oxlad, melissa; dodd, jodie; szabo, claudia; deussen, andrea; turnbull, deborah title: creating healthy change in the preconception period for women with overweight or obesity: a qualitative study using the information–motivation–behavioural skills model date: - - journal: j clin med doi: . /jcm sha: doc_id: cord_uid: qtfx qp worldwide, half of women begin a pregnancy with overweight or obesity, which increases the risk of pregnancy and birth complications and adversely affects the lifelong health of the offspring. in order for metabolic changes to influence the gestational environment, research suggests that weight loss should take place before conception. this study aimed to understand women’s emotional and social contexts, knowledge, motivations, skills and self-efficacy in making healthy change. semi-structured interviews conducted with twenty-three women with overweight or obesity, informed by the information–motivation–behavioural skills (imb) model, were analysed using reflexive thematic analysis. information-related themes identified included poor health risk knowledge, healthy food decisions and health versus convenience. the motivation themes comprised taking responsibility, flexible options, social expectations, interpersonal challenges and accountability. behavioural skills entailed themes such as the mental battle, time management, self-care and inspiration. an environmental factor was identified in affordability—limiting access to healthier alternatives. women wanted simple, flexible options that considered family commitments, time and budgetary constraints. unprompted, several mentioned the importance of psychological support in managing setbacks, stress and maintaining motivation. strategies for enhancing self-efficacy and motivational support are required to enable longstanding health behaviour change. findings will inform intervention mapping development of an ehealth solution for women preconception. worldwide, half of all women of childbearing age have overweight (body mass index (bmi) ≥ . to . kg/m ) or obesity (bmi ≥ kg/m ) [ ] . this figure is significant as retrospective, case-control and cohort studies have found that women who enter pregnancy with obesity are at higher risk of gestational diabetes mellitus (gdm) [ ] and pre-eclampsia [ , ] -both associated with long-term morbidities [ ] . a review of reviews on the risks of maternal obesity also found these women are more traditional weight-loss interventions across all life stages have included advice and strategies to adopt healthy behaviours via diet and/or physical activity. those adopting an interdisciplinary approach using behavioural strategies and psychological techniques, and specifically targeting the preconception period are almost non-existent. there are also significant barriers to behaviour change regarding healthy lifestyle. within the target group of women for this study, there is low health literacy, and they are often from low-income families. in a large stratified study on the socioeconomic differences in health behaviours, those with lower socioeconomic status (ses) also displayed less health consciousness (thinking about ways to keep healthy), stronger beliefs about the role of chance on their health and lower rates of thinking about the future [ ] . a qualitative study focused on improving health in women of childbearing age identified that dietary knowledge, cooking skills and the time and cost of preparing healthy food were significant barriers to adopting a healthier diet [ ] . a lack of support from partners and family members was also cited as a significant barrier to healthy change, likewise, finding the time and inclination to exercise. while preconception care largely focusses on women's health and care, fathers are increasingly becoming involved in pregnancy planning and lifestyle changes in efforts to conceive. however, little is known about partners' attitudes and roles in supporting positive preconception health behaviours [ ] . a high bmi category is associated with a range of co-morbidities, and poorer general health may affect motivation and perceived ability to adhere to healthy lifestyle recommendations [ ] . behavioural programs have the potential for substantial weight loss, yet significant problems remain due to program attrition and poor maintenance of healthy habits-with authors citing the lack of innovation as a factor in this area [ ] . significant gaps in knowledge exist, with further research exploring women's perspectives required to inform effective preconception health promotion strategies [ ] . this study aims to develop an understanding of preconception health awareness, potential barriers to adopting a healthier lifestyle, motivations, current behaviours and the practical skills required to change behaviour, for women with overweight or obesity. we sought to understand experiences from the women's perspectives [ ] consistent with the aims of the study in fostering empathy with their desires, needs and challenges. the intent is to understand the women's emotional and social contexts, to inform which behaviour change techniques and intervention components are likely to be most engaging. this qualitative study explored the perceptions and experiences of women related to healthy lifestyle change and weight management before conception. the information-motivation-behavioural skills (imb) model [ ] addresses some of the existing attitudes, beliefs and values that may impact behaviour [ ] and was used as the theoretical model for the interview topics. the model, which asserts that when individuals are well-informed, motivated to act, and hold the necessary behavioural skills, they will likely initiate and maintain a health behaviour [ ] , is highly applicable to obesity management [ , ] . the imb model is based on a critical review and integration of relevant constructs in social and health psychology theories and seeks to address limitations to these [ ] . the constructs are supported in the literature to improve healthy lifestyle behaviours and have been tested and used successfully in obesity prevention [ ] [ ] [ ] and in improving dietary and physical activity behaviours [ , ] . this model was chosen for its simplicity of structure and the fact that the constructs can be easily translated into intervention components. the imb model's elicitation-intervention-evaluation approach to the promotion of health behaviour, begins with seeking to identify this cohort's existing weight management knowledge, motivation and behavioural skills assets and deficits [ ] . individual determinants of behavioural change were explored: information, including behaviour-related information, knowledge about the impact of obesity, but also heuristics that permit automatic decision-making; motivation, comprising personal motivation (beliefs about intervention outcome and attitudes towards obesity prevention behaviours) and social motivation (including perceived social support for engaging in that behaviour); and behavioural skills (individual skills and self-efficacy) [ ] . qualitative investigation enables a deep and thorough understanding of the topic, yielding rich data [ ] , and is recommended to develop effective interventions [ ] . the relevant literature informed the development of the interview schedule, with probes allowing for exploration of topics driven by participants. under the belief that knowledge is socially situated [ ] , demographic information was also gathered, allowing the researchers to reflect on the relationship between the results and the sample [ ] . the present research, drawing on the problem-solving principles of design thinking [ ] , uses a human-centred approach that holds the emotional, functional and motivational needs of the user at the centre of the development process [ ] . this study represents the first phase of this process in empathic engagement-with these findings being used to inform the development of an ehealth solution using the intervention mapping approach. interview participants were a sample of women who have participated previously in diet and lifestyle intervention studies (the limit [ ] and/or grow [ ] randomised trials) at the women's and children's hospital-a high-risk specialty hospital with approximately deliveries annually-and who had given their consent to be contacted about future research. a purposeful sampling frame was adopted, with eligibility limited to those of reproductive age ( - years) [ ] , who were above the healthy weight range (bmi > kg/m ) and identified that they would like to lose weight. intention to become pregnant was not a prerequisite. women were contacted via telephone, with the purpose and methods of the study explained, and eligibility confirmed. those who expressed an interest in the research were emailed an information sheet and consent form, with interview times confirmed via email or telephone. the primary researcher (js) conducted twenty-three interviews during september . eight participants attended face-to-face interviews at the university of adelaide robinson research institute, with the remaining conducted via telephone. the interviews lasted - min (mdn = ). written consent was obtained from those attending a face-to-face interview, with verbal consent gained from those participating via telephone. the interviews followed after the consent process. the interviewer was a psychology researcher (js) trained in qualitative methods and interviewing skills, with knowledge of pre-pregnancy health and wellbeing, and no previous connection with any participants. a pilot interview was conducted with an eligible woman to determine the level of comprehension and natural flow of the intended questions, with this data excluded from the dataset as the interviewee was known to the researcher. after several interviews, some questions were revised for greater understanding, with others modified to broaden the scope for response. no further changes were made after the seventh interview. this process of revision is accepted as best practice within qualitative interviewing [ ] . each interview commenced with broader questions about lifestyle to build rapport. more sensitive and descriptive questions were asked later when participants were more comfortable. the interview schedule closed with questions that empowered the women to give their opinions and advice on the broader issue. questions were formulated to address the imb model constructs yet allowed scope for participants to speak freely outside of these topics. indicative topics included awareness of maternal and neonatal health risks, previous experience of weight loss, lifestyle and social factors, motivations, challenges and self-efficacy. a sample of questions is provided in table . participants who attended a face-to-face interview received a aud gift card as reimbursement for travel costs. after the interview, all women were provided with information on the maternal and neonatal health risks associated with overweight or obesity in pregnancy. all interviews were digitally recorded and transcribed verbatim by the first author. data analysis software nvivo ® [ ] was used to store and manage the transcripts, with each participant given a pseudonym and identifying information removed from the transcripts. despite recurring patterns indicating that code saturation was reached after participants, additional women were interviewed to provide meaning saturation-thereby identifying further insights and the nuances of issues required to understand this complex topic [ ] . it is believed that depth requires further data, especially for codes that are conceptual in nature [ ] . the analysis followed the six-phase process of reflexive thematic analysis set out in braun and clarke ( ) [ ] : familiarisation, generating codes, constructing themes, revising themes, defining themes and producing the report. this recursive process begins with repeatedly reading the data in an immersive manner to gain a sense of the whole. the analysis took both a deductive and inductive approach [ ] . while guided by the imb model and obesity literature, the coding process ensured that concepts falling outside of this were also captured. key concepts relating to the research aims were coded, then sorted into meaningful clusters that were assessed for applicability to the imb model constructs. two additional members of the research team (mo, dt) co-coded several transcripts to ensure rigour and transparency of interpretation, with the researchers working collaboratively to ensure the codes and candidate themes fit both the evidence, and the constructs of the imb model. the themes were then defined and named, with compelling extracts selected to illustrate the findings. perspectives that differed from the dominant beliefs were not excluded, with counter-instances considered to add rigour [ ] . the study was conducted in accordance with the declaration of helsinki, with the research approved by the women's and children health network (hrec/ /wchn/ ) and the university of adelaide human research ethics committee. this research was reported as per the consolidated criteria for reporting qualitative studies (coreq) [ ]-a -item checklist across three domains governing reflexivity, study design and analysis. each author approached the research from their respective positions and biases. while the primary researcher (js) who conducted the interviews, is not above the healthy weight range, she has an understanding of preconception health. the research team also comprised: a clinical and health psychologist (mo) with extensive experience in preconception care and health literacy; an obstetrician and academic researcher (jd) with extensive experience in maternity care; a digital technology specialist (cs) with an interest in its practical application within the health domain; a clinical trials manager (ad) within reproductive health and preventive medicine; and an academic researcher (dt) with a specialist interest in health psychology and maternity care. all authors are women with children of their own. a triangulated review process was used, with codes and candidate themes discussed by three researchers (js, mo, dt). an audit trail was maintained throughout data collection and analysis [ , ] , and participant confidentiality ensured by assigning pseudonyms. participants were able to review their transcripts to verify accuracy [ ] and were sent a summary of the findings [ ] . due to the sensitive nature of the topic, and participants not providing consent for sharing of their data beyond the current research, data will not be made publicly-available. a total of women, aged between and years (m = . , sd = . ) participated. each had between one and four children, with two women intending to conceive in the next months and three unsure on pregnancy intentions. participants self-reported their weight and height-most considered themselves above the healthy weight range (n = ), with bmi categories ranging between overweight ( . kg/m ) and obese class iii ( . kg/m ). all women expressed a desire to lose weight, with amounts ranging between five and kg. demographic characteristics of the participants can be seen in table . the themes identified in the data reflect the individual perspectives of participants concerning healthy lifestyle changes. these comprise four overarching themes: the imb model constructs (information, motivation, behavioural skills) and one issue beyond the scope of these (environmental factors) that encompass the diverse experiences of these women. within these, several themes were derived from the data, depicted in figure . the themes identified in the data reflect the individual perspectives of participants concerning healthy lifestyle changes. these comprise four overarching themes: the imb model constructs (information, motivation, behavioural skills) and one issue beyond the scope of these (environmental factors) that encompass the diverse experiences of these women. within these, several themes were derived from the data, depicted in figure . information-related themes included poor health risk knowledge, making healthy food decisions and health versus convenience. motivation-related themes-divided into personal and social motivation-included concepts such as taking responsibility, flexible options, interpersonal challenges and accountability. behavioural skills themes covered concepts such as the mental battle, time management, self-care and inspiration. the women conveyed their feelings and attitudes as they discussed previous experiences, their social environments, and aspects they considered presented barriers to adopting a healthy lifestyle. themes are presented in greater detail below. knowledge of the potential maternal and neonatal health risks associated with overweight or obesity before pregnancy was alarmingly low. while many participants had some knowledge of the risks to their health, most commonly gestational diabetes and pre-eclampsia, others expressed this knowledge in more general terms. of those who knew some of the risks, several disclosed they had experienced these in a previous pregnancy. information-related themes included poor health risk knowledge, making healthy food decisions and health versus convenience. motivation-related themes-divided into personal and social motivation-included concepts such as taking responsibility, flexible options, interpersonal challenges and accountability. behavioural skills themes covered concepts such as the mental battle, time management, self-care and inspiration. the women conveyed their feelings and attitudes as they discussed previous experiences, their social environments, and aspects they considered presented barriers to adopting a healthy lifestyle. themes are presented in greater detail below. knowledge of the potential maternal and neonatal health risks associated with overweight or obesity before pregnancy was alarmingly low. while many participants had some knowledge of the risks to their health, most commonly gestational diabetes and pre-eclampsia, others expressed this knowledge in more general terms. of those who knew some of the risks, several disclosed they had experienced these in a previous pregnancy. knowledge of neonatal health risks and outcomes was much less evident, with only half the participants able to recall any at all. of these, the majority were unable to describe them in detail or they were based on false information. while several women knew the risk of high birthweight, only two participants mentioned that the child may be at risk of having weight issues over their life course. however, some women did express informed knowledge of longer-term health risks for their child. "yeah well, stillbirth, um, high birth weight, um, i might be pulling this out of thin air, but i believe it puts your child at higher risk of having diabetes themselves." (amber, obese class ii) even those women who knew some of the risks to their health or their baby's health were unaware of the genetic traits they may pass on to their child, by entering a pregnancy with overweight or obesity. in many instances, participants only followed a healthy lifestyle after conception-discussing the more immediate effects of the foods they ate during the pregnancy and how this may impact the baby. " . . . you want what's best for your kids, and that starts from the second you see those two pink lines." (annie, obese class iii) when asked about the benefits of losing weight before pregnancy, some women expressed that they may fall pregnant more easily, and many conceded the healthier they were, the easier the pregnancy and birth would be, with less strain on their body and fewer complications. some requested information be freely available on the benefits, for themselves and their baby, of being a healthy weight before conception. many of the women had inadequate information on nutrition to make autonomous healthy food decisions for themselves or their families. while no participants were currently on an intensive weight loss program, some foods they reported consuming were carbohydrate-laden or high in sugar or fat-suggesting poor nutritional knowledge and self-monitoring of eating habits. for some, knowledge was based on misinformation such as considering some high sugar or "light" version of foods as healthy. " . . . i suppose an example is when i had gallstones and i wasn't supposed to be eating fat, i ate kabana [high-fat cured sausage], not realising that it was full of fat, and i ended up in the hospital with a gall bladder attack. it was just a . . . you know, a lack of information i suppose, i just didn't know." (erin, overweight) portion control, snacking, willpower and knowledge of consumption norms were among the greatest food challenges-even for those who considered their current diet to be healthy. positive health knowledge and behaviours were also displayed, with some reporting a good understanding of nutrition to aid weight loss. several women recognised the value in clean eating and shopping the perimeter of the supermarket to avoid heavily processed foods. "don't do fad diets, just eat clean. your food is % of it. if you've got your food under control, then . . . other things will fall into place." (elizabeth, overweight) while over half of the participants read the ingredients list and/or nutritional information panels, there appeared to be confusion around interpreting these. many appeared overwhelmed by the volume of nutrition advice available and whether it could be trusted. "there's a whole confusing world out there when it comes to diet" (mary, obese class iii) several women requested information being more freely available on healthy substitutions for unhealthy ingredients or dishes, plus alternatives to processed foods. participants emphasised the complexity of their lives, with busy schedules a contributing factor in choosing convenience meals over healthy ones. many women spoke of being too exhausted to cook and often relied heavily on processed foods or take-away, while half of the women reported cooking from scratch most of the time. physical and emotional exhaustion, general busyness and a lack of forward planning were cited as reasons for making poorer choices. when asked about their primary motivators for losing weight, some of the women expressed aesthetic motivators over health ones, in wanting to feel good about themselves and more confident. "almost entirely aesthetic. like i don't like the way i look in photos. and i understand the health risks, you know, the higher, higher incidence of diabetes, heart disease, all of the fat diseases, but that's not my main motivator if i'm honest." (amber, obese class ii) a powerful motivator for nearly all participants was role modelling healthy behaviours to their children, so they can also make good choices. several women did not want their children to focus on weight or dieting; instead, they wanted to set an example with positive health talk. within this, a couple of women conceded that the food they fed their children was much healthier than what they ate themselves. several women expressed their primary motivation was to improve their overall health, with some conceding that co-morbidities they suffered were an added incentive to lose weight. "just to feel healthier in myself. also to kick my depression a bit." (lucinda, obese class iii) most women cited several reasons for wanting to lose weight-even those with aesthetic motivators also wanted to provide a good example to others and see their children grow up. other reasons cited were to improve self-esteem, have more energy, feel proud next to their partner or to simply be a normal bmi. some women looked to the future, in wanting a long healthy life for their children, or more self-sufficient as they age. several expressed motivators related to the health of their potential baby or having an easier pregnancy. most women held positive beliefs about how important it was for them to manage their weight. it was widely recognised that they needed a "lifestyle" rather than a "diet"-having had negative experiences of weight loss programs in the past. many women attributed their excess weight to unhealthy behavioural patterns and felt a responsibility, whether trying to conceive or not, for managing their weight and health. " . . . trying to conceive, or have already had children and trying to conceive again, you know, you've got another body to look after, like it's not just you any more" (sasha, obese class ii) many women felt a sense of personal autonomy in choosing to improve their health-recognising that their lifestyle choices were modifiable and to have a healthy life, they had to take stock of their habits and change their mindset. "i don't blame my kids or my husband and i don't think that i don't have enough time." (mary, obese class iii) many were ready to change their lifestyle but perceived a barrier in making that first step-not knowing where to start in a task that seemed overwhelming. beliefs about other parts of women's lives often affected their motivation to begin a program of change. some women conceded they had no reason to eat unhealthily and were ignoring satiety cues or lacking in motivation. all participants had previous experience with trying to lose weight. these included meal replacement shakes, the ketogenic (or other low carbohydrate) diet, duromine or other diet pills, the "healthy mummy" app, intermittent fasting, weight watchers and counting calories. most had tried at least two of these methods. although some women had experienced success, many failed to lose weight or found the programs too restrictive, costly, or rigid to maintain with other responsibilities. women required options for both healthy eating and exercise that were flexible enough to accommodate family commitments. "i like taking the ideas from it, but i need the flexibility, with the family . . . for what's best to eat for us." (chloe, overweight) women talked about establishing a new routine that became an automatic habit. several women noted that they wanted a program that they could use long term to manage their weight. some noted that small steps and achievable goals would make women more motivated to succeed, along with devising a program that was simple to follow. social motivation many women reported feeling that societal norms dictated how they should look and feel and felt judged when they did not fit the "social" mould. some felt they were perceived differently due to their weight and did not want to shame their children or partners. . ] there's always going to be that voice in the back of your head that there is someone judging you, that doesn't even know you." (annie, obese class iii) a handful of participants could not relate to some of the advice or services they had accessed in the past, believing they target women who were already fit and a healthy weight, and found this de-motivating. despite experiencing hostility from others, or feeling out of place in fitness classes, some women were still able to push forward to improve their health. several women noted their partners were a barrier to eating more healthily, despite how supportive they may be in other ways. either they prepared unhealthy foods or ate unhealthy food in front of them. more than half of the women reported that their children were fussy eaters-which provided an added barrier to motivation, in that mothers preferred to cook food they knew their children would eat, at the expense of their own health. some struggled to strike a balance between healthy foods and the nutritional needs and preferences of their children, so as not to have to cook separate meals. "i've got two kids that are fussy eaters, to try and provide foods that are easy and carb-loaded for them [ . . . ] so that's where i've had issues with putting on weight, because trying to motivate the kids to eat and put on a bit of weight, you have to eat what they're eating. so, it's just trying to get that balance." (ella, obese class ii) some had difficulty convincing others of the need for healthy eating and felt this attitude sabotaged any efforts to lose weight. many women reported ongoing encouragement as holding power to maintain motivationregardless of whether they saw results-citing it as a significant reason not to abandon a healthy lifestyle program. "just nice words of encouragement, like you know 'you're doing a good job, and well done on you know, getting through the day, and you know, reaching your goal of however many steps' or 'it's ok you didn't get there today, but, you know, you're still doing good'." (olivia, overweight) women often find motivation wanes when "life gets in the way" and wanted gentle encouragement to keep on track after a setback. methods were highly individualized-while some wanted strategies that challenge on an individual level with personal messages, others found a group setting or competitive environment more motivating in that they saw others push themselves. the most powerful motivational support for women was seeing results-several had abandoned previous weight loss attempts due to not seeing results quickly enough. overwhelmingly, women felt they needed to be held accountable-some preferred a real person rather than goals set in an app, feeling they may be more likely to move the goalposts or lose motivation if they could not reach them. "i can fool myself pretty easily and make excuses for why i haven't done what i've done. it's different when you've got to explain to someone else your pathetic reasons for not having done something." (amber, obese class ii) several participants saw value in family members also committing to improving their health habits, to create an environment more conducive to success. some saw reciprocal benefits in encouraging others-such as peer interaction within an online support forum-and valued the camaraderie with those on the same journey. behavioural skills unprompted, several women mentioned psychological support in managing setbacks, stress and maintaining motivation-knowing the difficulties that can be encountered. " . . . mental health is a huge thing when you're trying to lose weight. [ . . . ] [it] can be really demoralising, especially if you're not achieving those goals. or if people around you are achieving them, and you're not." (elizabeth, overweight) weight management was viewed as much more complicated than just calorie input versus output. one participant noted that for most, obesity is about more than just food, and she would value being able to talk to someone about other issues that may impact behaviours. some women talked about their mental barriers and expressed the need to change their thinking around old habits. "you've really got to sort of train yourself mentally as well, to . . . um, eat better and to exercise more. it's kind of a mental battle as well." (olivia, overweight) participants overwhelmingly had stressful lives, with factors such as juggling work and caring for children, financial difficulties, children with complex health issues, or managing a hectic schedule contributing to this. for some, exercise was noted as being particularly beneficial for stress, with several women requesting stress management or mindfulness approaches within an intervention. some also valued a holistic approach incorporating increasing self-esteem too, with the belief it would help maintain good health decisions. most women recognised time as one of the biggest barriers to a healthier lifestyle. prioritising their health over other responsibilities proved difficult and contributed to the abandonment of previous weight loss attempts. some participants recognised that exercising would be easy if they were able to manage their time better. "i feel like it's just managing my time better isn't it? just getting up, even like a little bit earlier, i can do it in the morning . . . " (alex, obese class ii) some felt that time spent cooking from scratch or exercising meant that other priorities in their lives piled up and left them further behind. several women conceded that they do not really have an excuse not to eat well or exercise, but probably do not make the best use of their time, with "perceived busyness" often an excuse. "i think if someone can help you plan your whole day, so you can fit it in." (mary, obese class iii) exercise proved more of a challenge than healthy eating, and women wanted ideas for how to integrate physical activity into their lifestyle with small changes. women often felt a trade-off between spending time with their children and exercising, with the unpredictable nature of family life a barrier to maintaining physical activity and healthy eating regimes. many women also recognised other benefits, beyond weight management, in eating well and exercising. participants noted these self-care behaviours were rewarded with improvements in sleep, energy, clearer skin, mental clarity, less digestive issues, and some felt it gave them more motivation in other areas of their lives. overwhelmingly, women assigned greater importance to eating well than physical activity. "when i eat well, i feel well if that makes sense." (erin, overweight) some noted it took longer to notice the health benefits of physical activity, yet several women placed higher importance on exercise than healthy food, for the additional psychological benefits. "for me it's got the stress relief component, it's my 'me' time, it feels good, i feel good afterwards, i tend to be . . . i find the flow on effects, so when i exercise that's when i do tend to be less likely to go to straight the cupboard because i'm still feeling motivated." (chloe, overweight) it was also mentioned that, as mothers, they often prioritised everything else before their health. some found value in exercise as it allows them to focus on themselves, rather than just taking care of their families. many women lacked skills such as nutrition planning and meal preparation. participants indicated they often found healthy food boring or repetitive and wanted ideas to make meals more interesting and attractive to themselves and their families. " . . . knowing how to make foods interesting so you're not eating the same old things continuously [ . . . ] how to make vegetables more interesting [ . . . ] without adding massive amounts of calories to them." (lucinda, obese class iii) around half the women regularly cooked meals from scratch with fresh produce. while not always intentional with their meal planning, a handful of women noted they were skilled in creating basic meals, based on ingredients at hand and their personal preferences. some participants noted that what they needed was inspiration to implement changes. " . . . oh gosh, i need more inspiration than information" (amber, obese class ii) several women expressed a desire for basic meal plans and simple, quick recipes that were within their skillset, using easily accessible, cost-effective ingredients. women knew their old, unhealthy patterns of eating, and highly restricted regimes were not sustainable in helping them establish healthy patterns for weight loss. many wanted a more structured plan with interesting ideas for both nutrition and exercise. . . . theme: believing in myself to change my lifestyle several women noted they felt confident to make healthy changes to their diet and exercise levels, but motivation held them back. many placed caveats on their ability-contingent upon managing their time better, managing exhaustion, or finding adequate motivation. for some, previous successful experience of weight loss gave them confidence that they could make the changes required. "reasonably confident. i know i can do it. i know i can, because i've done that with little things, like the soft drink as i said. so i know i could do it." (erin, overweight) women often reported better results with changing their diet than exercising and expressed more confidence in being able to modify their diet. several cited the / rule-believing that weight loss is % diet and % exercise. given the correct information, many felt confident about easily integrating healthy foods into their daily life. however, a handful of women recognised that their lack of cooking skills might hinder their progress. some felt it would be easy to include physical exercise in their daily life, but only after attending to other responsibilities. environmental factors several women considered healthy food to be more expensive than convenience foods, and some cited this as a reason for their poor diet at times. they noted that the foods on special offer were the "cheat" foods, not the healthier options, and this influenced their purchase choices. "so it's more about finding the alternate to those expensive things [ . . . ] because it's very expensive starting a diet and that can sometimes put a lot of people off, because budget-wise you just can't fit it in. and i find that's why people go for the easy foods, because it is cheaper." (april, overweight) especially for families with limited income, cost encouraged reliance on cheaper fat-, sugar-or carbohydrate-laden foods. frozen or packaged food was sometimes bought in favour of fresh, as it could be relied upon if money was tight. leaner cuts of meat were also seen as less affordable. " . . . that makes it a bit harder sometimes, especially if we're like, tight on money and the only thing that we can whip up is like sausages and packet pasta and stuff like that." (carla, obese class iii) some were unable to continue with previous weight management programs due to food costs. physical exercise often presented a cost barrier too, with several noting the cost of gym memberships, boot camp and exercise clothing suitable for overweight women. this qualitative investigation examined the experiences and beliefs of women with overweight or obesity related to managing their weight before pregnancy. in general, the participants displayed poor health literacy on the impact of entering pregnancy with overweight or obesity. while some women were aware of the risks to their health, few recognised the potential risks to their future baby. this finding corresponds with previous research noting a poor understanding of neonatal outcomes for pregnant women with overweight or obesity [ ] . while preconception care and counselling may include advice about smoking, alcohol intake, nutritional supplementation and immunisations, less attention has been paid to diet and lifestyle advice for women with overweight or obesity [ ] . the topic holds such sensitivity that it is often not raised by doctors during consultations. previous systematic review research has found that the beliefs and attitudes of partners, peers and family exert a powerful influence on women's health behaviours that may undermine the advice of health professionals [ ] . the fact that many women reported interpersonal challenges suggests that partners need greater involvement in the process of preconception counselling and creating and supporting a healthy lifestyle. pregnancy is considered a powerful "teachable moment" [ ] for weight control and health behaviour change, which enhances the perceived value of nutrition and exercise. while the focus of the current study has been on efforts women can undertake in the preconception period to maximise outcomes for their child, pregnancy is often a joint endeavour and partners are becoming increasingly involved in preconception planning. it is evident that partners can help or hinder women in their efforts to make lifestyle changes. it is crucial that any future intervention consider the impact of partners including ways to foster social support by making lifestyle or behavioural changes themselves, and to reduce social pressure by lifting the stigma around weight. this would provide a supportive environment to initiate healthy change within the whole family. interestingly, many of the women conceded they were motivated more by aesthetics and social expectation than health considerations. this finding reiterates previous research that found motivations beyond health, such as self-image, may be more engaging for some women [ ] , and enable those not yet considering pregnancy to be captured by the public health messages. while it has been reported that between % [ ] and % [ ] of pregnancies are planned, it is thought that women with overweight or obesity are more likely to have unplanned pregnancies [ ] and therefore are less able to optimise their health before conception. thus, interventions may need to target not just those intending to conceive, but all women of childbearing age. for many women in the study, the prime consideration was being healthy during the pregnancy, rather than in preparation for conception. greater understanding of the health implications of weight status may provide an added motivation to improve lifestyle. while the current study is concerned with behaviour change on an individual level, interactions with surrounding influences-family, community, plus social, environmental and policy contexts-exert a powerful force on health behaviours, as noted by many of the women in this study and previous research [ ] . a two-pronged approach is required-empowering women with the tools to change the way they respond to the environment, and also changing their environment, where possible, to make healthier choices easier to make. the sugar tax, intended to create shifts in consumer behaviour, has reduced sugar consumption in the united kingdom and mexico [ ] , with higher effects for lower-income households. while food taxes and subsidies have not yet been implemented in australia [ ] , it stresses the importance of giving women evidence-informed guidance they can trust, but also individual support to counteract obesogenic environments [ ] . unsurprisingly, nutrition knowledge was relatively poor amongst participants, with many consuming processed foods high in sugar or fat. it is known that unconscious and instinctual processes can prompt poorer eating practices, with people relying on heuristic cues to make food decisions which often lead them to choose larger and less nutritious options [ ] . heuristics are mental shortcuts-in this instance, made in response to contextual food cues and are thought to reduce the cognitive depletion associated with making health decisions [ ] -especially salient in a population with lower health literacy. many women had requested simple solutions, rather than complex calorie-counting and food logging. these findings emphasise the need for interventions to respond to the preference for heuristic processing, to help people make better choices with regard to food, portion control, even leisure activities, as suggested in a previous study [ ] . previous experience of dieting practices meant that many of the women were wary of highly restrictive eating regimes, which often affected adherence and success. this result corresponds with previous research on barriers to following a mediterranean style diet for women of childbearing age [ ] , with women perceiving the term "diet" to have negative connotations. the language used will be critical to the success of any future intervention, a sentiment shared by previous research on public perceptions of the terms used to improve eating habits [ ] . this information highlights the need to frame the intervention with clear communication and a positive focus, along with making guidelines more flexible to accommodate busy lifestyles and families, as noted by previous research [ ] . accessibility was also problematic, with the perception that healthy food was more expensive-a finding common to other studies [ , ] . this finding points to the need for education on better food choices and substitutions-being mindful of budgetary constraints. women had stressed the importance of social support, encouragement and accountability, suggesting the need for an inclusive community to be created, where women feel empowered and supported to reach their goals-as noted in previous research on mutual-help groups [ ] . avenues for peer support have never before been so important, with social barriers such as those imposed by the covid- pandemic, along with caring responsibilities for other children, giving women less opportunity to interact with peers and health professionals for encouragement. many participants also recognised the benefits of a healthier lifestyle beyond weight loss itself. a holistic intervention therefore presents an opportunity to promote factors such as stress reduction, increased self-esteem, improved mental health or role modelling. several women in the study expressed a need for psychological support along their weight loss journey. a technology-delivered motivational interviewing approach [ ] could provide tactics to increase self-efficacy through small steps and achievable goals, elicit change talk and garner family support. a regime of establishing and recognising partial success in changing behaviour, plus strategies to manage setbacks, may promote greater motivation to continue. mindfulness-based interventions may have particular relevance for obesity with a meta-analysis suggesting benefit for improving both psychological health and eating behaviours [ ] . likewise, open trial and case series evidence suggests that cognitive behavioural therapy (cbt) [ ] and acceptance and commitment therapy (act) [ ] can provide useful adjuncts to other behavioural techniques for weight management. however, few studies exist that assess these techniques when delivered via digital health intervention. an ehealth intervention offers a solution that is low cost, high reach, with the potential for personalisation and the use of adaptive and agile design to improve efficacy. this study presents an opportunity to understand the behaviour change techniques and digital functionality to which women may best respond. in-depth qualitative research is crucial in understanding the personal experiences and the contexts within which potential intervention users live, and to help tailor interventions to specific life stages. this person-based approach complements the theory-and evidence-based approaches to intervention development [ ] . an intervention mapping approach will be guided by these interviews, the literature on obesity, behaviour change and psychological techniques. it is hoped that themes and subthemes derived from this study, having been identified by the women as important, will directly inform modules to be delivered in the intervention. the intent is to develop an intervention that the women want to engage with, using strategies that address some of the existing barriers to change and help them to create a sustainable healthy lifestyle. to date, there has been little qualitative research conducted into the experiences and beliefs of women regarding weight management before pregnancy-within an australian context. to the authors knowledge, there have been none that use the imb determinants of behaviour within this specific target group. this cohort displayed a diverse profile across age, family circumstance, bmi and socioeconomic factors. credibility was added through the multivocality of the participants, with the authors aware of the empathic understanding required to let this wide range of insights emerge. both the interviews and analysis were conducted with rigour, adhering to best-practice guidelines for qualitative research [ , ] . the research was not without limitations. the women interviewed were not necessarily intending pregnancy (n = intending pregnancy in next months, n = unsure, n = not planning pregnancy in the next months). therefore, motivations may be different from those in the preconception phase. however, it is thought that similar health and role-modelling sentiments would stand for those intending pregnancy, in wanting the best outcomes for their children. the women were recruited from a pool who had previously participated in studies concerning gestational weight gain, so may have prior knowledge of managing their weight through pregnancy in a supported manner. in addition, some women reflected on previous pregnancies in their responses, discussing lived experience of the health risks associated with their weight status. moreover, the cohort was not culturally diverse, in that recruitment was limited to those who spoke english. the cultural implications of dietary and social habits need to be considered and, therefore, future research with diverse populations is recommended. the preconception period is now acknowledged as a critical window in which to intervene for preventing obesity in pregnancy, with significant potential benefits-both health and economic. however, obesity is a complex and challenging issue, with multiple genetic, social, environmental and behavioural influences. promoting meaningful change in this group requires a multifactorial approach, involving a complex interaction between the necessary determinants of behaviour-information, motivation, and behavioural skills. this elicitation study, the first step in the imb approach to health behaviour change, provided insights about the beliefs and psychosocial contexts of women in this particular population. important factors for consideration include psychological support, flexibility, enhancing self-efficacy, motivational support and affordability. 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technology-delivered adaptations of motivational interviewing for health-related behaviors: a systematic review of the current research mindfulness-based interventions for adults who are overweight or obese: a meta-analysis of physical and psychological health outcomes the effectiveness of cognitive behavioral therapy with mindfulness and an internet intervention for obesity: a case series the person-based approach to intervention development: application to digital health-related behavior change interventions the authors would like to sincerely thank the women who participated for their generosity in sharing their thoughts and experiences with us. we would also like to thank the coordinating team who supported recruitment in this study: deussen a, kannieappan l. the authors declare no conflict of interest. the funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. key: cord- -q qndic authors: onyeaka, henry k; zahid, shaheer; patel, rikinkumar s title: the unaddressed behavioral health aspect during the coronavirus pandemic date: - - journal: cureus doi: . /cureus. sha: doc_id: cord_uid: q qndic the novel coronavirus ( -ncov) pneumonia has been declared a pandemic, citing more than , cases of the coronavirus illness in more than countries and territories around the world. public health emergencies have been demonstrated to have an impact on the behavioral health of the affected population as they may experience fear, anxiety, anger and post-traumatic stress disorder as consequences of their experiences. these effects may persist among affected individuals long after the outbreak has been controlled. to date, data on the behavioral distress and psychiatric morbidity of those suspected or diagnosed with the -ncov and their treating health professionals are lacking. although the centers for disease control and prevention (cdc) has outlined some behavioral health guide for affected individuals, how best to respond to psychological challenges during the crisis is not known. there is an urgent need to provide robust and timely psychosocial support in the face of such an outbreak. the novel coronavirus ( -ncov) pneumonia, which originated in the hubei province in china at the end of , has gained intense attention nationwide and globally. in the united states, since the first case was detected in washington, dc, in mid-january , the virus has continued to spread. as of march , , a total of , confirmed cases have been reported in jurisdictions ( states, district of columbia, puerto rico, guam and us virgin islands) and has resulted in deaths [ ] . on march , the world health organization (who) declared -ncov a pandemic, citing more than , cases of the coronavirus illness in more than countries and territories around the world and the sustained risk of further global spread. while the exact origin remains largely unknown, the virus has been shown to cause respiratory illness ranging from mild to severe and is spread via human to human transmission. at the moment, the therapeutic strategies to deal with the infection are only supportive and preventive. based on the available information regarding the virus, upgraded quarantine and isolation measures have been suggested to resist the spread of the virus. the centers for disease control and prevention (cdc) has issued detailed guidelines and recommendations to stem community spread of the virus. of the affected population [ ] . individuals and their families with confirmed or suspected -ncov may experience fear, anxiety, anger and post-traumatic stress disorder as consequences of their experiences. these effects may persist among affected individuals long after the outbreak has been controlled. furthermore, contact tracing and the mandatory quarantine isolation for two weeks, which is a crucial part of the public health responses to the -ncov pneumonia outbreak, could be a precursor for increased psychological distress such as posttraumatic stress disorder, anxiety and anger among suspected or confirmed cases [ , ] . also, the estimated global economic shutdown and recession is expected to heighten fears and anxiety. health professionals, especially those directly caring for people with confirmed or suspected -ncov pneumonia, are susceptible to both high risk of infection and behavioral health distress. the literature has documented high levels of psychological distress among healthcare workers in previous outbreaks. they may experience fear of contracting and spreading the virus to their families, friends or colleagues. in a cross-sectional study by wu et al., the healthcare workers who had been quarantined, or worked in the high-risk location such as severe acute respiratory syndrome (sars) wards, or had friends or close relatives who contracted sars, were significantly more likely to have high post-traumatic stress symptom levels than those without these exposures [ ] . to date, data on the behavioral distress and psychiatric morbidity of those suspected or diagnosed with the -ncov and their treating health professionals are lacking. although the cdc has outlined some behavioral health guide for affected individuals, how best to respond to psychological challenges during the crisis is not known. there is an urgent need to provide robust and timely psychosocial support in the face of such an outbreak. therefore, using lessons learned from prior epidemics like sars, middle east respiratory syndrome and the ongoing -ncov in china, some potential methods to mitigate the psychosocial impact of the pandemic should be emphasized. first, it is the provision of clear, accurate and updated information about the virus to both health workers and patients in order to allay their anxiety and fear. second, robust behavioral health services should be deployed to deliver behavioral health support to patients and health workers with additional training of more healthcare professionals in psychological first aid delivery to the high-risk population. lastly, given the present challenge of cross-infection from the onsite and face-to-face delivery of healthcare, telehealth and other remote forms of behavioral health delivery should be encouraged. the current -ncov outbreak may stretch the already limited behavioral health services, and prompt measures must be instituted to avert the potential acute and long-term psychological sequela that may ensue. coronavirus disease long-term psychiatric morbidities among sars survivors the psychological impact of quarantine and how to reduce it: rapid review of the evidence mental health status of people isolated due to middle east respiratory syndrome the psychological impact of the sars epidemic on hospital employees in china: exposure, risk perception, and altruistic acceptance of risk in compliance with the icmje uniform disclosure form, all authors declare the following: payment/services info: all authors have declared that no financial support was received from any organization for the submitted work. financial relationships: all authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. other relationships: all authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. key: cord- - kwfulqe authors: yue, jing-li; yan, wei; sun, yan-kun; yuan, kai; su, si-zhen; han, ying; ravindran, arun v.; kosten, thomas; everall, ian; davey, christopher g; bullmore, edward; kawakami, norito; barbui, corrado; thornicroft, graham; lund, crick; lin, xiao; liu, lin; shi, le; shi, jie; ran, mao-sheng; bao, yan-ping; lu, lin title: mental health services for infectious disease outbreaks including covid- : a rapid systematic review date: - - journal: psychological medicine doi: . /s sha: doc_id: cord_uid: kwfulqe the upsurge in the number of people affected by the covid- is likely to lead to increased rates of emotional trauma and mental illnesses. this article systematically reviewed the available data on the benefits of interventions to reduce adverse mental health sequelae of infectious disease outbreaks, and to offer guidance for mental health service responses to infectious disease pandemic. pubmed, web of science, embase, psycinfo, who global research database on infectious disease, and the preprint server medrxiv were searched. of reports identified, were included in this review. most articles of psychological interventions were implemented to address the impact of covid- pandemic, followed by ebola, sars, and mers for multiple vulnerable populations. increasing mental health literacy of the public is vital to prevent the mental health crisis under the covid- pandemic. group-based cognitive behavioral therapy, psychological first aid, community-based psychosocial arts program, and other culturally adapted interventions were reported as being effective against the mental health impacts of covid- , ebola, and sars. culturally-adapted, cost-effective, and accessible strategies integrated into the public health emergency response and established medical systems at the local and national levels are likely to be an effective option to enhance mental health response capacity for the current and for future infectious disease outbreaks. tele-mental healthcare services were key central components of stepped care for both infectious disease outbreak management and routine support; however, the usefulness and limitations of remote health delivery should also be recognized. the coronavirus disease pandemic is the largest threat to the world in this century (who, ) . to limit transmission, business and school closures are implemented, mass quarantines (brooks et al., ) are imposed and self-isolation and social distancing (kaplan et al., ) are highly recommended, and such measures have been implemented in almost all countries to differing extents (galea, merchant, & lurie, ; ho, chee, & ho, ; jung & jun, ; li et al., a li et al., , b . millions of people in the world have been infected, with ever increasing numbers under quarantine or in isolation. fear of illness, severe shortages of resources, social isolation, large and growing financial losses, and increased uncertainty will contribute to widespread psychological distress and increased risk for mental illness and behavioral disorders as a consequence of covid- (pfefferbaum & north, ) . the worldwide impact of the covid- pandemic on mental health has already been identified as including insomnia, anxiety, and depression among healthcare workers and other vulnerable populations tang et al., ; brooks et al., ; cao et al., ; gao et al., ; gonzalez-sanguino et al., ; holmes et al., ; king, delfabbro, billieux, & potenza, ; li et al., a li et al., , b shi et al., ; wang et al., a wang et al., , b wang et al., , c xiao, zhang, kong, li, & yang, ) . chinese healthcare workers exposed to the covid- pandemic reported symptoms of depression ( . %), anxiety ( . %), insomnia ( . %), and psychological distress ( . %) (lai et al., ) . these symptoms also manifest in the general population, whose prevalence of depression, anxiety, insomnia, and acute stress was . , . , . , and . %, respectively . similar types of symptoms have accompanied other infectious disease epidemics such as severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers), and ebola virus disease (evd) (ho et al., ; jalloh et al., ; pfefferbaum & north, ; vyas, delaney, webb-murphy, & johnston, ; wu et al., ) . people discharged from hospital after recovering from covid- have reported high rates of posttraumatic stress disorder (ptsd) (bo et al., ) . a systematic review showed that after severe coronavirus infection, the point prevalence of ptsd was . % ( % ci . - . ), depression was . % ( . - . ), and anxiety was . % ( . - . ) (rogers et al., ) . some mental health problems persisted for years with a quarter of sars patients having ptsd, and . % having depression years after experiencing sars (mak, chu, pan, yiu, & chan, ) . early detection and recognition of covid- -related psychiatric symptoms is pivotal for tailoring cost-effective accessible interventions. mental health responses could enhance coping and lead to recovery from this massive worldwide psychological trauma of covid- and the pandemic. given the developing situation with coronavirus pandemic worldwide, policy makers urgently need an evidence synthesis to produce guidance for the development of psychological interventions and mental health response. the aim of this paper is to synthesize the data on mental health services and interventions for the infectious disease epidemics, and to enhance knowledge and improve the quality and effectiveness of the mental health response to covid- and future infectious disease epidemics. we sought to include any articles focusing on mental health interventions or services applied specifically for infectious disease outbreaks. we searched pubmed, web of science, embase, psycinfo on may , using a combination of text words and mesh terms: (sars or severe acute respiratory syndrome or middle east respiratory syndrome coronavirus or middle east respiratory syndrome* or mers-cov or mers or middle eastern respiratory syndrome* or merscov* or coronavirus or coronavirus infections or coronavirus* or covid- or -ncov or sars-cov- or ebola) and (mental disorders or mental health or mental health programs or mental health services or public health services or emergency services psychiatric or emotional trauma or psychosocial interventions or psychiatric interventions or psychological treatment or psychotherapy). we also searched who global research database on covid- using the term 'mental health', and the preprint server medrxiv with search terms 'sars or mers or ebola or coronavirus or covid- ' and 'mental health' on april . articles about mental health services (e.g. mental health system, mental health measures or strategies) and specific types of psychological interventions for infectious diseases such as sars, mers, evd, and covid- were included in the present review. we excluded articles on the epidemiology of psychological impacts, mental health responses to other types of diseases, and non-english publications. all articles were independently screened for eligibility by two reviewers (syk and yw) on title and abstract. all full-text articles identified were reviewed by yjl and byp. for each retrieved fulltext article, we hand searched the article's references and examined possible additional studies. original intervention trials were independently critically appraised using the cochrane collaboration's quality assessment tool by two reviewers (ssz and yk) (higgins et al., ; higgins & green, ) . consensus was used to resolve any disagreements. review authors' judgments evaluated selection bias, performance bias, detection bias, attrition bias, reporting bias, and other bias. in all cases, an answer 'l' indicates a low risk of bias and an answer 'h' indicates high risk of bias. if insufficient detail was reported of what happened in the study, the judgment will usually be 'unclear' risk of bias. the pubmed, web of science, embase, and psycinfo search identified , , , and articles, respectively. the who global research database on covid- identified articles and medrxiv identified articles. there were articles left after removing those articles which were duplicates from the six searches. hand searching of full-text articles yielded one additional reference to include in this review. in total, eligible articles were included in this review (see fig. ), most focusing on covid- , followed by evd, sars, and mers. of the articles, one used a randomized controlled trial (rct), seven used quasi-experimental methods or pre-post intervention or quantitative interview, reported processes of the delivery of care but did not rigorously evaluate outcomes ( reports, commentaries, and reviews) (see table ). twenty-three articles described mental health practices and services for covid- [china ( ), south korea ( ), singapore ( ), italy ( ), and one each for canada, germany, usa, uk, malaysia, iran, australia, and spain], seven articles for evd [sierra leone ( ), liberia ( ), and usa ( )], one article for sars (hong kong, china), and one article for mers (south korea). four different mental health practices were reported in this systematic review, including mental healthcare systems, psychosocial interventions, specific responses of psychiatric hospitals and digital mental healthcare (see fig. table ). table summarizes the assessment of risk of bias for five controlled trials. the majority of the intervention trials showed a low risk of bias, or we were unable to determine the risk. one trial had low risk of performance bias and detection bias, one trial had high risk of selection bias, and we were unable to determine the risk for other trials. all five trials had low risk of attrition bias, reporting bias, and other biases. as the other records included in this review were not controlled trials or were commentaries, we did not conduct quality assessments for them. governments have variously developed interventions and response systems to deal with the mental health problems caused the mental health professionals provided psychological counseling to individuals in quarantine. national hospitals and community mental health centers also provided mental health care services. leaflets promoting mental health care for the distress caused by infectious disease outbreaks were distributed. percudani et al. italy covid- report (-) regional health authorities authorized the continuation of mental health services for the general population. safety guidelines for both medical staff and patients were implemented, including remote psychosocial interventions and telemedicine. hospital admissions for acute psychiatric disorders in patients positive for covid- need a dedicated area in the psychiatric ward or alternatively, a medical ward supported by psychiatric staff. (continued ) jing-li yue et al. ( ), their families ( ) the community-based mental health system of detection, brief intervention, and refer to treatment was established for the quarantined mers patients and their families. service utilization rate, . % receive one consultation, . % required continuing services, . % received continuing services. albott et al. ( ) small group cbt developed to treat anxiety, depression, and functional impairment, eight sessions over weeks. at post-intervention, anxiety, depression, and functional impairment significantly reduced, helping . % of the participants to their personal goals or recovery. overall, the intervention was given a mean rating of . out of by the participants. ping et al. malaysia covid- report nurses on the covid- frontline ( ) ultra-brief psychological interventions for month including group problem-solving techniques, mindfulness skills and so on. the informal qualitative feedback has suggested that it has helped respond effectively to individuals with anger or frustration, anxiety secondary to the uncertainty of the daily fluctuations of covid- , panic and tension in committee meetings, and the general psychological wellness of hospital staff. kazerooni et al. iran covid- report medical junior students ( ) near peer mentoring via the social media platform. senior students under the supervision of expert faculty offered psychological supports for junior students such as stress relaxation techniques, time management, etc. % of junior medical students believed the platform had a significant impact on helping them adjust faster to these emergency conditions. decosimo et al. sierra leone children who were ebolasurvivors; living in ebola-infected homes or community ( ) a community-based psychosocial arts program (playing to live). activities included storytelling, musical freeze dance, art drawing, yoga, and dancing. contrasted a -month to a -month treatment. significant decrease in reported symptoms in both treatment groups pre-to post-intervention and a significant difference in total symptoms over time. waterman et al. sierra leone evd quantitative interview ex-etc staff ( ) -week group cbt program for depression and anxiety modeled on evidence-based low-intensity interventions. barriers (lack of motivation to attend, low literacy) and enablers (novelty of cbt, social network). waterman et al. sierra leone evd pre-post intervention ex-etc staff ( ) three-phased cbt-based intervention. improvement of ptsd, sleep, depression, anxiety, and alcohol usage. sierra leone the general public, inpatients general nurses were trained in pfa, case identification and referral pathways and provided basic counseling and problem-solving therapy for individuals in the need of mental healthcare. kohrt et al. liberia evd pre-post intervention mhcs ( );law enforcement officers ( ) adapting the cit model implemented a national community-based anti-stigma program, family support and advocacy activities, and facilitated partnerships to advance mental health policy, legislation, and funding. the anti-stigma and advocacy activities involved work with journalists, pharmacists, religious leaders, and other stakeholders. there is a need to develop formal collaborations with law enforcement for stigma reduction, service provision, and human rights protection. there was a significant increase in knowledge ( - % of items answered correctly), a significant increase in positive attitudes, and a significant decrease in social distance. (continued ) jing-li yue et al. the 'strength-focused and meaning-oriented approach to resilience and transformation' intervention using a cognitive redefinition was applied. after the -day group debriefing, participants showed significant decrease in depression level and changes in cognitive appraisal toward sars. such changes were sustained in a -month follow-up. garriga et al. (yoon, kim, ko, & lee, ) . various mental health centers such as public health centers, community mental health centers cooperatively delivered services for mers patients and the national center for crisis mental health management evaluated people using these services and subsequently transferred them to local community mental health centers for continuing case management and follow-up. the service utilization rate was high, but they also found that the referral system from the national level to regional or local levels did not work well (yoon et al., ) . while active detection of subjects with emotional difficulties and interventions following the covid- outbreak was a potential option, they needed a more efficient process for an open entry system at the local level rather than a triage system starting nationally from the top. a series of mental health-related actions were taken at the initial stage of the covid- outbreak in china (li et al., , b qiu, zhou, liu, & yuan, ; wang et al., a wang et al., , b wang et al., , c yao, chen, zhao et al., ; zhou, ) , singapore (ho et al., ) , south korea (jung & jun, ; park & park, ; yoon et al., ) , canada (agyapong, ) , germany (bauerle, skoda, dorrie, bottcher, & teufel, ) , italy (percudani, corradin, moreno, indelicato, & vita, ) , and the usa (schreiber, cates, formanski, & king, ) . specifically, mental health professionals including psychiatrists, psychiatric nurses, and psychologists were deployed to provide psychological counseling and support for vulnerable populations (e.g. frontline healthcare workers, confirmed covid- patients, suspected covid- cases and their families) in china and for people in quarantine in south korea. the national health center of china (nhc) issued several guidelines and plans (nhc-china, b , c , d . several national associations related to mental health and academic societies cooperated to establish expert groups on psychological interventions to older adults (wang et al., a (wang et al., , c . psychoeducational books, articles, and videos were made available for the public through e-platforms and mobile apps (e.g. wechat) at the early stage of the covid- outbreak in china (bao, sun, meng, shi, & lu, ; li et al., a li et al., , b pfefferbaum et al., ) . several hospitals, individual psychiatric departments, community psychiatric partners, and psychologists all provided online psychotherapy and counseling to psychiatric patients and the general public with covid-related psychological distress through videoconferencing platforms (e.g. zoom) in singapore (ho et al., ) . leaflets for the general public provided guidelines for coping with the covid- distress and hotlines provided information for covid- mental health crisis that might occur in south korea (park & park, ) . canada launched a support text message (text mood) program to respond to the psychological impact of covid- . this program provided free psychological supportive text messages daily for months (agyapong, ) . germany's 'coping with corona: extended psychosomatic care in essen' (cope) offered psychological support for distressed individuals, which included four steps: initial contact, triage and diagnosis, support via tele-or video-conference, and aftercare. this program offered psycho-educational information materials about resources, relaxation techniques, and mental health (bauerle et al., ) . increasing public mental health literacy is vital to prevent and overcome the mental health crisis during the covid- pandemic. education and support from the voluntary and professional mental health sectors should be a part of mental health prevention under large infectious disease outbreaks. psychological and physical supports tended to be specifically matched to different vulnerable populations, such as children, older adults, and health care workers. a national community-based anti-stigma and advocacy activity, which is a curriculum based upon the crisis intervention team (cit) model was launched in liberia during the evd outbreak, could significantly decrease mental health and public health problems including violence, self-harm and suicide (kohrt et al., ) . a mental health unit was created at connaught hospital in sierra leone during evd outbreak (kamara et al., ) . general nurses were trained in psychological first aid (pfa), case identification, and referral pathways, and provided basic counseling and problem-solving therapy for individuals with mental healthcare needs. a nurse-led approach within a nonspecialist setting appears to have been successful for delivering mental health and psychosocial support (mhpss) services during the evd outbreak. peer support programs or services led by nonprofessional mental health workers are potential ways to deliver care in areas with limited human resources and weak social welfare systems. an alternate strategy which was employed during the sars outbreak in hong kong (ng et al., ) was the strength-focused and meaning-oriented approach to resilience and transformation (smart). this intervention employed a body-mind-spirit framework with a strong emphasis on cognitive redefinition of the stressful situation and the individual's response. results of the rct (n = ) suggested that participants' depression levels and adaptive changes in cognitive appraisal of sars decreased significantly after the single-day group debriefing. as this intervention trial included only a small sample, its efficacy needs to be replicated in a larger sample, and should include a follow-up study. for children and adolescents a community-based psychosocial arts program created by playing to live (ptl) was established for children who were ebola-survivors or living in ebola-affected homes or communities (decosimo, hanson, quinn, badu, & smith, ) . the ptl group hired and trained ebola-survivors to run the ptl activities two to three times a week in their communities. they also hired psychosocial workers to provide weekly supportive talks to families, and information about childcare and child rights. the ptl activities included storytelling, musical freeze dance, art drawings, yoga, and dancing. results of the pre-post-evaluation (n = ) suggested that the -month program was associated with a % reduction in symptoms including social withdrawal, extreme anger, bedwetting, worry/anxiety, poor eating habits, violence, and continued sadness, whereas the -month intervention group showed a % reduction of such symptoms. for older adults for mental disorders of old age, particularly dementia, there have been limited reports of the effects of the covid- pandemic. we found only one report on mental health care for older adults among our included papers. given the high death rate among older adults infected with covid- and the added strain on families with older relatives and on the institutions caring for them, the chinese society of geriatric psychiatry in collaboration with the chinese society of psychiatry responded with an interdisciplinary solution. mental health professionals, social workers, nursing home administrators, and volunteers collaboratively delivered mhpss for older adults, especially for community-dwelling residents and nursing-home residents (wang et al., a (wang et al., , c . mental health care for older adults during this epidemic was not given enough attention in the early stage of outbreak. more specific age-appropriate interventions may need to be developed for older adults for effective intervention during pandemic in the future. for healthcare workers frontline health care workers are also shouldering a greater mental health burden, and thus need support in strengthening their resilience through peer support and other interventions . first, proper protection against their own infection is critical. for example, masks, personal protective equipment, and other essential medical equipment (e.g. ventilators) will help relieve the stress of having to treat people with infections, and improve their mental wellbeing. during this covid- crisis, various interventions were offered to healthcare workers, such as a peer-supported resilience intervention in the usa (albott et al., ) , e-package with agile methodology in the uk (blake, bermingham, johnson, & tabner, ) , and the ultra-brief psychological intervention in malaysia (ping et al., ) . the e-package in the uk included evidence-based guidance, support, and signposting relating to psychological wellbeing, and results of this pre-post intervention (n = ) revealed that % of healthcare participants used the information in their work or home lives (blake et al., ) . feedback from healthcare workers suggests that qualitative wellness is improved by providing a free online resource manual targeting psychological skills and interventions to reduce the distress caused by uncertainty during the pandemic (ping et al., ) . many countries have developed dedicated teams to provide mental health support for healthcare workers; however, the type of support needed depends on the stage of the pandemic, and can benefit from peer and professional counseling (isaksson rø, veggeland, & aasland, ) . the anticipate, plan, and deter responder risk and resilience model was used to assess and manage healthcare workers' psychological risk and resilience during the evd outbreak (schreiber et al., ) . the anticipate, plan, and deter model contains three components. first, pre-deployment training about the stressors that healthcare workers may face during deployment ('anticipate'). second, development of a personal resilience plan ('plan') and monitoring stress exposure during deployment using the web-based system. third, invoking the personal resilience plan when risk is elevated ('deter'), addressing responder risk early before the onset of impairment. psychological support was offered to junior medical students in iran via a novel social media platform during the covid- (rastegar kazerooni, amini, tabari, & moosavi, ) . in total, % of participants (n = ) believed the platform had a significant impact on helping them adjust faster to these emergency conditions. following the evd outbreak in sierra leone, cognitive behavioral therapy (cbt) was widely used among ebola treatment center (etc) staff (cole et al., ; waterman et al., ; waterman, cole, greenberg, rubin, & beck, ) . results of the pre-post intervention (n = ) showed that small group cbt could significantly reduce anxiety, depression, and functional impairment of etc staff after eight sessions over weeks (cole et al., ) . workshops with different themes such as pfa, stress, sleep, depression, anxiety, relationships, and behavior were developed in phase and . participants still displaying high anxiety and depression levels after phase and were enrolled in phase with low-intensity cbt strategies. significant improvements in the stress, anxiety, depression, and anger domains were reported, but no improvement in sleep (waterman et al., ) . cbt is an evidence-based intervention delivered through various means besides face-to-face interactions. for example, delivery over the internet or smartphone apps can be efficient for broad outreach to the populations at risk for mental health complications. the feasibility and effectiveness of training a national team to deliver a three-phase cbt-based group intervention to ex-etc staff suggested that this model protected healthcare workers from negative psychological consequences of potentially traumatic stressors (waterman et al., ; waterman et al., ) . however, the effectiveness of this model and its components needs more rigorous evaluation, because it relied on a single small sample during a unique epidemic (schreiber et al., ) . furthermore, most of the reviewed studies were pre-post measurements with substantial heterogeneity in the included participants, methods, study designs, and outcomes. standardized evaluations in randomized clinical trials were difficult to implement due to the urgent nature of the pandemics. evidence-based interventions that have shown efficacy in conditions differing from epidemics also might be effective approaches to combat covid- , but their effectiveness needs to be tested in controlled trials during the covid- pandemic. psychiatric hospitals in china prepared to cope with the covid- outbreak by establishing crisis psychological intervention teams across many psychiatric hospitals, including psychiatrists, clinical psychologists, and psychiatric nurses (li et al., , b shao, shao, & fei, ; xiang et al., ) . a specialized psychiatric ward was established in an infectious disease hospital in wuhan on february , and in turn isolation wards were established in psychiatric hospitals for mentally ill patients with suspected or confirmed covid- . nhc issued a set of guidelines in february to standardize the management of patients with severe mental disorders during the covid- outbreak (nhc-china, f ). subsequently, the chinese society of psychiatry published guidelines to the hospital administration applicable to both psychiatric hospitals and psychiatric units in general hospitals during the outbreak (chinese society of psychiatry, ). psychiatric hospitals reduced outpatient visits, tightened admission criteria, and shortened the length of inpatient hospitalizations. for newly admitted psychiatric patients, isolation wards were set up and visiting was suspended to minimize the potential risk of nosocomial infection. additionally, the majority of psychiatric hospitals used telemedicine to provide psychiatric consultations for infected patients and medical treatments for patients with preexisting mental disorders, and antipsychotic drugs were often delivered to patients' homes following the covid- outbreak in china. the italian society of epidemiological psychiatry also issued operational instructions for the management of mental health departments and similar measures were employed in italy (starace & ferrara, ) . the institute of mental health (imh) in singapore implemented a series of prevention and control strategies at the levels of hospital, ward, and individual (poremski et al., ) . except for restrictions on patients and visitors, medical staff were managed effectively, for example, electronic tracking of staff movement to facilitate contact tracing in singapore (poremski et al., ) and china (shao et al., ) . for community care centers and out-patient clinics, in-person visits were recommended for patients with a psychiatric emergency, risk of psychiatric relapse or new emergent cases with mental disorders, incorporating phone call follow-ups and telepsychiatry consultations in spain (garriga et al., ) . as per in-patients, early discharges of the psychiatry emergency rooms and acute wards were moved forward and the suspension of family visits was implemented. a novel mental health home hospitalization care was recommended (garriga et al., ) . the infection control measures needed to limit potential exposure to sars-cov- led to inaccessibility of some mental health interventions such as injectable medications and electroconvulsive therapy, and the relative risks and benefits of these treatment losses need to be evaluated . these losses should be assessed in the balance with many novel strategies involving digital telemedicine, mental health home hospitalization, commercial drug delivery, and electronic tracking. moreover, follow-up studies are needed on how effective these interventions were in mitigating the mental health impacts of other losses to mental services and patients. tele-mental health services were prioritized for individuals at higher risk of exposure to covid- infection such as frontline clinicians, infected patients, suspected cases of infection, their families, and policemen. there are well-documented reports of china proactively providing various tele-mental health services during the covid- outbreak zhou et al., ) . the nhc and the chinese psychological society provided guidelines on conducting online mental health services (li et al., , b nhc-china, a . these services were provided by the government, academic agencies (e.g. hospitals, universities, institutes), associations of mental health professionals, and non-government organizations. the services included counseling, supervision, training, as well as psychoeducation through e-platforms (e.g. hotline, wechat, weibo, tencent qq, alihealth, and haodaifu) (moe-china, ) . additionally, online self-help psychological interventions such as cbt for depression, anxiety, and insomnia were also developed . early reports indicated high interest and acceptance of these services by the target population. the 'national crisis intervention platform for covid- ' was created with mental health professionals. several hospitals set up their own crisis counseling system for staff and patients using telehealth in many provinces of china kang et al., ) . the australian government had delivered a wide range of telehealth services including telehealth consultations to general practitioners and specialists . however, to date, the australian government has focused on managing the physical health needs of the population during the epidemic, with less focus on mental health . access to other existing tele-mental health support services such as self-help platforms, videoconferencing, or mobile apps for depression, anxiety, and emotional problems should be made available for the general population . telehealth has become a cost-effective alternative for delivering mental health care during the covid- global pandemic when in person and face-to-face visits are not possible. solid evidence supports the effectiveness of telephone and web-based interventions, especially for alleviating symptoms of depression, anxiety, and ptsd (kerst, zielasek, & gaebel, ; turgoose, ashwick, & murphy, ) . videoconferencing, online programs, smartphone apps, text-messaging, and e-mails have been useful communication methods for the delivery of mental health services (torniainen-holm et al., ; zhou et al., ) . national and provincial digital mental health services (e.g. hotlines, websites, wechat, weibo) have been established as essential measures to address mental health needs of key target populations such as healthcare providers during the covid- outbreak. however, digital therapies might not be appropriate for older or demented people, people with reading difficulties, poor people, or people who are not technologically adept. the combination of online and offline psychological counseling is a key strategy for mental health services and intervention systems during the covid- pandemic. this paper provides a rapid review of the published literature on mental health practices and services during recent infectious disease epidemics. except for publications on some mental health intervention systems and psychosocial interventions, most other reports were not specifically designed to evaluate the feasibility and effectiveness of mental health interventions. more evidencebased psychosocial interventions with telehealth services and considering contextual adaptation, complexity, and resources requirements are needed during the covid- pandemic and future outbreaks of infectious diseases. during infectious disease outbreaks such as covid- , measures implemented for their prevention (e.g. quarantine and isolation, business or school closures) as well as the losses induced by them (e.g. finance, food, personal freedom, social connection, and relationships) contributed to significant emotional distress, reduced mental well-being, and may lead to psychiatric or behavioral disorders in both the short and long term. these consequences are of sufficient magnitude, requiring immediate efforts and direct interventions to reduce the impact of the outbreaks at both individual and population levels (galea et al., ) . psychoeducation and emotional support in particular help to normalize crisis reaction, mobilize resources, and increase adaptive coping strategies for progression to serious mental illness such as major depression or ptsd (north & pfefferbaum, ; north, hong, & pfefferbaum, ; reyes, ) . however, many countries have tended to focus on the physical health needs of covid- , often neglecting mental health needs with few designated organizations offering specific mental health services with easy access to those in need. the integration of mental health provisions into the covid- (and other infectious disease emergencies) response should be best addressed at the national, state, and local planning levels (pfefferbaum & north, ) . call for evidence-based psychosocial interventions to cope with the covid- pandemic prevention efforts in mental health were implemented primarily for people who were at risk or had greater vulnerability, such as frontline workers, confirmed covid- patients, infected family members, and those affected by the loss of loved ones (holmes et al., ) . mhpss programs through international organizations were used effectively in several low-and middle-income countries during infectious disease outbreaks (cenat et al., ) . for example, group-based cbt (waterman et al., ; waterman et al., ) , pfa, ptl (decosimo et al., ) , culturally adapted interventions such as smart (ng et al., ) , ultra-brief psychological interventions (ping et al., ) and peer supports (rastegar kazerooni et al., ) have been reported to effectively mitigate the emotional impacts of covid- , evd, and sars outbreaks. however, the quality of evidence was still restricted because limited studies have provided quantitative data, and most intervention studies included small numbers of participants. during the covid- pandemic, other evidence-based interventions can be applied, and their feasibility and effectiveness should be evaluated. for example, mindfulness-based interventions (hofmann & gomez, ) or cbt for insomnia (koffel, bramoweth, & ulmer, ; riemann et al., ; trauer, qian, doyle, rajaratnam, & cunnington, ) can be assessed for their effectiveness in the provision for individuals suffering from severe sleep problems or chronic anxiety symptoms. psychosocial interventions can provide support for individuals in the wake of a crisis and can increase the perceived safety of individuals, further ameliorating maladaptive stress reactions and reducing emotional distress (slavich, ) . people with major losses or those with more severe illnesses are more vulnerable to experience depression, suicidal ideation, or ptsd in the initial phase of the pandemic or even after it ends (north, suris, davis, & smith, ). evidence-based trauma-focused psychotherapies and pharmacotherapy are appropriate. for specific subgroups, family intervention may be recommended (dawson et al., ; forbes et al., ; north & pfefferbaum, ) . facing the pandemic, measures for identifying, triaging, referring, and treating severe psychosocial consequences, death notification, and bereavement care should be established (north & pfefferbaum, ; pfefferbaum & north, ; . moreover, for the lower income countries, with greater scarcity of mental health resources, implementation or modification of evidence-based psychological treatments, such as psychological treatments to be delivered by non-specialist providers including through task sharing, is urgently needed (barbui et al., ; singla et al., ) . evaluating the effectiveness of interventions to mitigate covid- 's mental health consequences on patients the degree of risk for infection with covid- for individuals with severe mental illnesses has not been clearly established; however, it is reasonable to presume such risk to be higher than that of the general population, because of disordered mental state, possible poor self-care, inadequate insight, or side effects of psychotropic medications (starace & ferrara, ; xiang et al., ) . furthermore, adverse social determinants brought about by the covid- pandemic, including poverty, food insecurity, and stigma, can be contributory (lund et al., ) . people with severe mental health problems commonly live in poverty which impacts their ability to socially distance themselves from neighbors or the local community and increases transmission risk. psychiatric inpatients confirmed or suspected covid- could be treated in specialized wards in infectious disease hospitals or in isolated wards in psychiatric hospitals or shelter hospitals equipped with psychiatric consultations. as for psychiatric hospitals, measures including strict triaging/precautionary procedures and admission criteria, and shorter hospitalization length of stay should be taken to prevent the clustering of covid- cases (chinese society of psychiatry, ; shao et al., ; starace & ferrara, ) . additionally, mental health home hospitalization care was recommended (garriga et al., ) , and medical staff management in psychiatric hospitals such as electronic tracking of staff movement might facilitate contact tracing (poremski et al., ) . however, follow-up studies on how effective these interventions were in mitigating covid- 's mental health impacts on mentally ill patients are needed. these studies should balance the risks and benefits of these alternative interventions on mental health services among patients and providers. the potential of digital therapy programs which can offer costeffective evidence-based therapies has not been fully realized. however, awareness of the disparities in access to the technology of poorer populations and cultural and linguistically diverse communities in low-and middle-income countries may have an impact on their implementation (naslund et al., ) . the effectiveness of digital mental health interventions in such countries has not been rigorously evaluated. online mental health services' utilization is still low in china and australia . however, telehealth remains a valuable way of reducing psychosocial distress without increasing the risk of infection. during infectious disease outbreaks, telemental health services can enable remote triaging of care, offer cognitive and/or relaxation skills to deal with stress symptoms, encourage access to online self-help programs, and deliver professional psychological interventions if necessary. simple communication methods such as e-mail and text messaging can and should be used more extensively in low-income countries. however, many of these interventions require more rigorous jing-li yue et al. assessments to determine their efficacy, effectiveness, treatment retention, and outcomes. investing in the collection of evidence on the outcomes, workforce requirements, patient engagement, and ethical uses of tele-mental health services will allow them to truly deliver their full potential . telehealth and digital services should not completely replace face-to-face treatment for patients in need, particularly those requiring intensive mental health treatment and support including wider deployment of injectable long-acting medications and hands-on interventions such as electroconvulsive and transcranial magnetic stimulation therapies, when in-person contact is once again safe. several limitations of this systematic review need to be considered. first, few rcts on the effectiveness of mental healthcare interventions on mitigating mental problems during any of these infectious disease outbreaks were identified, and more highquality rct studies are needed. second, due to the limited number of studies on psychological interventions during infectious disease outbreaks, and the heterogeneity of evaluation methods, we only could provide a systematic review without a formal meta-analysis. third, relatively few countries have reported mental health services and treatments during infectious disease outbreaks, more high-quality studies are in need to form culture-adapted efficient and nationally unique mental health responses for infectious disease outbreaks. the pandemic of covid- brings huge challenges for mental health systems worldwide which have to rapidly change, but also can offer an opportunity for improvement of mental health responses, and lead to long-term development of sustainable mental health care systems. despite differences in political, social, and health systems, mental health services worldwide have implemented acute responses that focus on care for mental health service users, and have facilitated access to mental health assessment and care for new-onset or high-risk patients. more evidencebased interventions should be implemented during epidemics especially for vulnerable populations such as children, older adults, and healthcare workers. the effectiveness of alternative digital interventions in mitigating the mental health consequences on mental services and patients should be assessed in follow-up studies. tele-mental health strategies and global cooperation are sound approaches to develop and implement 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coronavirus disease (covid- ) outbreak in january in china rethinking online mental health services in china during the covid- epidemic mitigating mental health consequences during the covid- outbreak: lessons from china system effectiveness of detection, brief intervention and refer to treatment for the people with posttraumatic emotional distress by mers: a case report of community-based proactive intervention in south korea psychological crisis interventions in sichuan province during the novel coronavirus outbreak the role of telehealth in reducing the mental health burden from covid- acknowledgements. we appreciate an-yi zhang, yi-jie wang, xiao-xing liu, xi-mei zhu, ze yuan, chen-wei yuan and meng-ni jing for their help with the data search. conflict of interest. none. key: cord- - eduslpb authors: griffiths, s.; reith, g.; wardle, h.; mackie, p. title: pandemics and epidemics: public health and gambling harms date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: eduslpb nan when we started the process of creating this special issue of public health, we were seeking to respond to an increasing call to recognise gambling harms as a public health problem and to address concerns about a potential growing epidemic of harms that threatened the health and well-being of populations across the globe. that this is increasingly being accepted as a public health issue, albeit among a relatively small field of gambling researchers and practitioners, is not in question. however, the question that faced us was what such a response, for this journal, at this point in time, should look like. we began to realise that what was needed was a kind of 'next step'. an evolution of discussion that goes beyond the simple repetition that 'gambling is a public health problem' brings the issue to a wider audience of academics, public health and healthcare professionals. and for this to include what public health policy and practice might be in the future. to facilitate mature debate, we needed to help public health, primary care and healthcare professionals see that gambling is not necessarily a harmless pastime, and to understand that gambling harms contribute to many of the social and economic inequalities that are determinants of health and well-being for individuals, their families and the communities in which they live. in short, we needed to bring what was known from the evidence base to the readers of this journal. as with any issue of public health, we wanted to do that in a way which helped readers see both the reason for the concerns relating to gambling harms across the globe and the potential for translating such evidence into public health action. this issue is the result of those discussions. what we did not discuss was how you present a special issue of public health on what some are coming to see as an epidemic of gambling-related harms, when the world is experiencing a global pandemic. at the time of writing, covid- is still an emerging disease. whilst we await population surveillance based on antibody testing, containment measures will continue to focus on the isolation of symptomatic cases and social lockdowns. across the world, public health attention has, naturally, been directed towards the pandemic response, whether locally or as advisors for national and local politicians. yet, even in the midst of this pandemic, we need to be aware that gambling harms are still occurring. the pandemic has not interrupted gambling, merely changed how it is happening. we can but speculate on how keeping people in their own homes, many without their usual occupations, activities and social networks, might impact their use of online gambling platforms. obviously, sporting events have been cancelled and land-based venues closed during lockdowns, vastly reducing the availability of gambling, but other options online have sprung up. as competitive sports and horse racing restart, albeit behind 'closed doors', and social distancing continues to affect the footfall in gambling venues, in the us at least, one company has created 'drive-thru' gambling centres. debate has already started about the impact the covid- pandemic has had on gambling behaviour. industry commentators point to lost revenues, which are likely to be significant. the industry will regroup and a critical business consideration for them will be how to future-proof itself against such shocks of this nature. a greater push to online gambling seems inevitable. it may also be tempting for governments to use gambling expansion and its subsequent revenues to recover resources which will be a priority with the inevitable economic depression looming. however, from a public health perspective, we need to focus on people, not purses. we need to consider the impact on individuals and communities and to assess how gambling harms are changing in the context of our vastly altered postecovid- world. in britain, as elsewhere, one of the aims of gambling legislation is stated to be the protection of the vulnerable. importantly, vulnerability is not a static state but something that may vary for individuals based on their life experiences and conditions. in the context of great economic and social uncertainty, it is vital to understand who are the new 'vulnerable' and what measures should be put in place to protect them. this may mean taking and maintaining a more precautionary approach to gambling regulation whilst the knowledge about impact is generated. covid- is likely to create many more vulnerable people and to exacerbate existing inequalities: inequalities that are already expressed in the distribution of gambling harms. it is vital that politicians, regulators and public health officials are sighted of these changes and able to respond rapidly. what this collection of special articles shows is how varied and diverse the experience of gambling harms can be, how far reaching for individuals, families and communities, and how global the potential impact could be. vulnerability to harms is manifest through socio-economic or cultural status, through the areas in which people live and through the practices engaged in by the industry. these things are not simply the preserve of the individual but of individuals embedded within their broader social and environmental contexts. it is particularly heartening to see the local actions being undertaken that are sensitive to these contexts. at the same time, covid- aptly reminds us of the global reach of gambling and the need to embed local responses within global strategies to reduce harm. that the world health organization (who) is starting to take interest in championing strategy in this area is positive. yet, there is much still to do. research and policy nearly always plays catchup to industry developments. the industry, especially the online industry, is sophisticated in its use of data and technology to promote, protect and expand its services. increasingly, researchers interested public health jo u rn a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / p u h e in gambling will have to also be interested in data science and technological infrastructure if they are to truly understand the nature of gambling products, the industries responsible for generating them and their impacts. we agree a new framing is necessary: we need to acknowledge that the context of people's lives, broader social, economic and environmental circumstances and the actions of politicians, regulators and corporations, along with individual characteristics, can all influence behaviours. this is a public health framing, one where responsibility lies with multiple actors and agencies for preventing gambling harms. in britain, as politicians begin the process of reviewing the gambling act and updating it for the digital world, there is the potential for such change to occur. but it requires bold thinking and e crucially e action to overcome challenges in how to deliver such a joined-up, global and systems-based approach to reducing gambling harms. the articles in this special issue offer hope that with sustained effort and action, this may be possible. we all recognise that the world into which we will return will be very different, and within that new world, we will have an opportunity to do things differently. once the immediate pandemic is past its peak and lockdown is slowly released, the public health community will refocus on what recovery will be needed and begin planning for the new normal. with this pandemic, we are already seeing questions being asked about how we can 'reset' rather than 'recover'. paine ( e ), the british-born american political theorist and revolutionary, wrote: 'we have it in our power to begin the world over again'. as we reset from the covid- pandemic, should we not see this as a real opportunity to rebuild the world in a way that also addresses and reduces gambling harms? if we are to have the sort of mature discussion around building the public health response to gambling harms, this is an important time to start. competing interests p.m. reports serving as an advisor to the scottish chief medical officer and the scottish government on the public health response to gambling harms. p.m. reports being invited to speak at the launch of the gambling commission's national strategy to reduce gambling harms in scotland. he reports not being remunerated for this. he reports receiving funding from the gambling commission to undertake a project developing a public health strategy to prevent gambling harms in glasgow for his employing agency, public health scotland. this funding was provided as part of a regulatory settlement to the gambling commission. between may and march , h.w. reports serving as the deputy chair of the advisory board for safer gambling, an independent group that provides advice on gambling policy and research to the gambling commission and was remunerated by them. she reports working on one project funded by gambleaware on gambling and suicidality in the last three years. h.w. reports running a research consultancy, heather wardle research ltd. she reports not providing consultancy or any other services for the industry. she reports providing evidence at the house of lords select committee enquiry into the social and economic impact of gambling as an unpaid expert witness in summer . she reports serving as a member of who panel on gambling. s.g. reports serving as an emeritus professor at the chinese university of hong kong which has institutionally received charitable and research support from the hong kong jockey club. she reports being the deputy chair and trustee of gambleaware, which is unremunerated, chair of the safer gambling board which is responsible for the betregret campaign. in addition, s.g. reports being an associate non-executive board member of the public health england board global health committee. g.r. reports currently being a member of the world health organization's panel on gambling and the howard league's commission on problem gambling and crime. neither position is remunerated. she reports receiving research funds from the national institute for health research, the economic and social research council, the medical research council and the british academy in the past three years. between and , she reports being a remunerated member of the responsible gambling strategy board (now the advisory board for safer gambling): an independent body that advised the gambling commission on research and strategy. william hill punters bet on table tennis in sports lull common sense: (appendix) key: cord- - w t x authors: booss-bavnbek, bernhelm; krickeberg, klaus title: dynamics and control of covid- : comments by two mathematicians date: - - journal: nan doi: nan sha: doc_id: cord_uid: w t x we are asking: why are the dynamics and control of covid- most interesting for mathematicians and why are mathematicians urgently needed for controlling the pandemic? first we present our comments in a bottom-up approach, i.e., following the events from their beginning as they evolved through time. they happened differently in different countries, and the main objective of the first part is to compare these evolutions in a few selected countries with each other. the second part of the article is not"country-oriented"but"problem-oriented". from a given problem we go top-down to its solutions and their applications in concrete situations. we have organized this part by the mathematical methods that play a role in their solution. we give an overview of the main branches of mathematics that play a role and sketch the most frequent applications, emphasising mathematical pattern analysis in laboratory work and statistical-mathematical models in judging the quality of tests; demographic methods in the collection of data; different ways to model the evolution of the pandemic mathematically; and clinical epidemiology in attempts to develop a vaccine. since the covid- pandemic is not over it may appear to be premature to draw some conclusions. however, it may be, as well, just in time to recapitulate some lessons we as mathematicians should have learned and are urged to apply now. thus we are asking: why are the dynamics and control of covid- most interesting for mathematicians and why are mathematicians urgently needed for controlling the pandemic? we shall first present our comments in a bottom-up approach, i.e., following the events from their beginning as they evolved through time. they happened differently in different countries, and the main objective of this first part is to compare these evolutions in a few selected countries with each other. still, there are some general features, which we present separately as we are used to do in mathematics. they include the history of certain epidemics which have influenced the reactions of people in many countries, and some basic mathematical tools. in addition there is a common factor, which one of the present authors (kk) has defined on the th march in an e-mail to a german health office: "the extension and evolution of covid- in various countries and regions reflects the state of their health systems. this was for instance already very obvious in the case of ebola." it is in fact the public health component of the health system that plays a crucial role. the second part of the article is not "country-oriented" but "problem-oriented". from a given problem we go "top-down" to its solutions and their applications in concrete situations. we have organized this part by the mathematical methods that play a role in their solution. here is an example where specially much mathematics is needed: to develop a vaccine and the strategy for applying it without loosing sight of basic ethical principles. in the following the gentle reader may consult when necessary the book [kpp] for the basic concepts of epidemiology. demography as a mathematical subject area was already developed centuries ago well beyond its elementary beginnings. for a long time it remained the only mathematical tool in the study of the evolution of infectious diseases. here is a famous early example. in china, india and europe one tried to confer immunity against smallpox by infecting individuals slightly so they would contract a mild form of the disease and be immune afterwards. some of them died by this procedure but in the swiss mathematician daniel bernoulli showed by a demographical approach that the procedure would increase life expectancy if applied to everybody [di ] . nowadays evaluating the costeffectiveness of a public health measure is being done widely; it is based on methods of mathematical economy. the th century saw the discovery of microorganisms as pathogens of many diseases and their study by mainly microbiological methods. the mathematical tools for following up an epidemic remained essentially demographical well into the th century. a few physicians suggested that every epidemic ends because there are finally not enough people left to be infected, which is a naïve predecessor to the mathematical-epidemiologic concept of herd immunity (see sect. ). nevertheless even the abundant literature on the influenza pandemic of - , wrongly called spanish flu, discusses only two possible ways for its ending: better clinical treatment and mutations of the pathogen. seen from a virological viewpoint the spanish flu was an extreme form of the so-called seasonal influenza. the virus which causes them can be one of a large variety, its genus being denoted by a, b, c or d, where some of them include several species. a is the most serious one; is has subtypes a(hxny), x = ,..., and y = ,..., , where x and y represent proteins on the surface of the virus. the strategy for controlling the "normal" seasonal influenza epidemic is widely known even among laymen: identify the strain of the virus in autumn, develop a vaccine as fast as possible, and vaccinate people thought to be at risk. nevertheless the number of infections and of deaths by a seasonal influenza can be as high as those by some of the pandemics to be described now. the spanish flu was due to a(h n ). pictures from that time show people wearing masks that resembled those used now. in the years - another "digression" from seasonal influenza occurred, called the asian flu and caused by a(h n ). it started in china and then became a pandemic, passing from neighbouring states through the uk and the usa. estimations of the number of cases vary around millions and of the number of deaths around millions. its beginnings looked much like those of the spanish flu but towards the end a vaccine became available, a predecessor to the ones being used now routinely against the seasonal flu. the hong kong influenza of - , generated by the virus a(h n ), had similar characteristics and will not be described further. parallel to the entering the scene of these and other epidemics, and partly motivated by them, basically new mathematical tools of public health emerged in the first part of the th century, preceded by a few studies in the late th . they were twofold. the first tool was called a "statistical-mathematical model". its aim is the study of the influence of factors, also called determinants, on the health of people. such factors may for instance be a lack of hygiene or a polluted environment. a factor can also be a preventive or curative treatment by an immunization or a drug, respectively; in that case the main objective of a study is to estimate the efficacy of the treatment. sampling plans are statistical-mathematical models of a different but related kind. they form the basis of sample surveys, which are being done in profusion about covid- , too, and not always very illuminating. the second tool is called "mathematical modelling of the evolution of an epidemic", or briefly "mathematical modelling". there are two kinds of it. first, one may aim at the epidemic curve, which is the cumulated number of cases up to a moment t as a function of covid- booß-bavnbek &krickeberg, august t . in that case mathematical modelling serves to estimate or predict this curve under various assumptions on the infectivity of infected subjects. early predecessors are presented in [fin] , see figure ; the question whether the infectivity remains constant or decreases played already a role. refined versions are still being used, in particular for covid- (sect. ). early numerical simulation of an epidemic curve by j. brownlee, , discussed in [fin] second, one may build so-called compartmental models (sect. ). the first one, for measles, was published in by p.d. en'ko; see [di ] . around the year compartmental models for malaria appeared. then in the s new models for the evolution of measles in closed populations were defined and intensively studied. they became very influential because they displayed already many basic features that reappeared later in mathematical models of epidemics in other and more complex settings. such tools found many applications. dealing with large epidemics mathematically was no longer a matter of demography alone, although that continued to be the main tool for estimating number of cases and deaths. statistical-mathematical models were employed to estimate the efficacy of antiviral drugs, for instance against hiv-infections, and the efficacy of various immunizations including those against forms of influenza. mathematical modelling of epidemics was used in planning strategies to eradicate smallpox, poliomyelitis, measles and perhaps others. the first articles on modelling influenza epidemics appeared in the scientific literature. planning a vaccination strategy involves both statisticalmathematical and mathematical models [hal] . these roads to progress may have produced a general feeling of success in dealing with epidemics. then in the period from to a few events occurred that evoked memories of previous pandemics and undermined such believes. in finally another zoonotic influenza appeared, popularly called bird flu and in scientific language highly pathogenic avian influenza (hpai). the main pathogen was an a(h n ) influenza virus. it had been known long ago but reached a peak in the years - . whether there existed an airborne transmission from poultry to humans was a hotly debated question with obvious economic consequences. the bird flu spread widely over the whole world but the number of known human cases remained small, just over . in addition to various forms of influenza and the epidemics generated by the corona virus sars-cov- , sars-cov- or mers-cov, other epidemics occurred. it is instructive to compare them with those just mentioned, applying in addition mathematical yardsticks. we shall restrict ourselves to ebola epidemics. their most widespread outbreak was the western african ebola virus epidemic from to , which caused , cases and , deaths. there is a fundamental difference in the evolution of a case of influenza or sars-cov- or sars-cov- on the one hand and of an ebola case on the other, which leads to a basic difference in their mathematical modelling (sects. and ). a carrier of an influenza or corona virus can transmit it to other persons well before the first symptoms appear, that is well before the end of the incubation period. a subject infected by ebola will become infective only around the end of the incubation period. he (if it is a man) could then be immediately isolated together with his latest contacts in order to avoid further extension of the infection, provided that there is a health service nearby to do it. therefore ebola did not spread to countries that have a sufficiently dense primary health care network but it caused much suffering in countries that do not have it. the strategy of who to control the epidemic was wrong. it insisted on drugs and the search for a vaccine (which became available only in december ) but neglected primary health care. for the present purpose it would even have been most useful to rapidly train village health workers and "barefoot doctors" as it had been done decades ago. only very few countries profited from the experiences of these premonitory years to prepare much in advance for a possible, and probable, new outbreak of an epidemic. some others took appropriate measures only at the first signs of covid- , and many started planning when the epidemic had almost reached its zenith. we shall sketch some examples. for simplicity we shall always describe the result of the strategy of a country by indicating its cumulated numbers of confirmed cases and deaths around the st june . regarding the reliability of these data see sects. and . we begin with those that had planned early. , the year after the sars-epidemic outbreak, the government established the national health command center (nhcc), which was to prepare the country for a possible new epidemic. from on it was headed by the popular minister of health, chen shih-chung, who had studied dentistry at the taipei medical college. the vice-president of taiwan from to , chen chien-jen, had been minister of health from to after having studied human genetics, public health, and epidemiology at the national taiwan university and the johns hopkins university in the usa, followed by research. thus decisions about the control of covid- were taken by politicians competent in matters of health including public health. taiwan counts million inhabitants and many of them travelled from and to china. from the st december on when who was notified of the epidemic in wuhan all incoming flights from there were checked, followed by controls of passengers arriving from anywhere. an "action table" was produced in the period th january to th february , which listed measures to be taken. the public obtained daily revised clear information by all existing means. "contact tracing", which means repeated followup of symptomatic persons, of confirmed cases and of all of their contacts, was rapidly established on the basis of the electronic health insurance card that everybody has. the virological pcr-tests used (sect. ) were already available and quarantines well organised. in late january rules about the wearing of masks were edited; a sufficient supply existed already. as a result confirmed cases had been found and deaths recorded up to the st june. the vietnamese strategy resembles the taiwanese one in almost all aspects, with the exception of contact tracing. a steering committee to deal with new epidemics existed within the ministry of health. it put into effect its plan right after the rd january when the first infected persons arrived at vietnamese airports, among them a vietnamese returning from the uk. all schools were closed on the th january, and since the st february everybody entering vietnam must spend two weeks in quarantine. other measures were imposed or relieved in accordance with the evolution of the epidemic, for instance a limited confinement or the wearing of masks. the ministry of health issued regular precise and clear information for the entire population by all available means including smartphones. in addition there is a personalized information system by so-called "survival guides" given to everybody. every survival guide defines three categories of persons: f : a confirmed case; f : suspected to be infected or having had contact with an infected person; f : having had contact with a person in f . each person is expected to find the category to which it belongs. the survival guide then provides printed information about what she or he must do as a function of her or his category, for example to submit to a test. only pcrtests are being used. in contrast to taiwan contact tracing does not use electronic tools. it is being done by the population itself, aided by the survival guides, together with a large number of well-trained members of the health services, for example university lecturers. at the end of vietnam had , , inhabitants. on the st of june there had been confirmed cases and deaths. these data are based on a strong demographic section of the "general statistical office" and on several health information systems [kkr] and can hardly be contested. the preceding sketch of control measures in taiwan and vietnam has shown us the three main components of their epidemiologic side: contact tracing; lock-down, that is physical, or social, distancing in the wide sense including quarantine and border controls; wearing of masks. we may call this the "surveillancecontainment strategy". in addition there is the medical-clinical side, from primary health care such as general practitioners up to large hospitals. its state is crucial to the number of deaths caused by the virus sars-cov- . in contrast to taiwan and vietnam it seems that all other countries of the world were unprepared at the end of december . a few of them took fairly systematic and strict measures that covered the entire population as soon as the first cases had declared themselves. for a quick overview see figure . this was for example true for china at the end of january , for slovakia and greece on the th and th february, for austria on the th march and for denmark on the th march. an alternative danish strategy, based on rigorous contact tracing and quarantine, but not implemented until now was argued for in [sia] . regarding the results the turbulent evolution in china is well known. in denmark, with a population of . million, about , cases had been confirmed and deaths recorded, and the corresponding figures for austria are . million people, , cases and deaths. the confrontation of slovakia, a country of around . million inhabitants, with greece, which counts . million people, is particularly striking because it makes visible the role of their physicians and hospitals. in slovakia there were , confirmed cases and deaths. the corresponding data for greece are , and . the relatively much higher number of fatalities in greece, in spite of equally early reaction and almost the same number of cases per number of inhabitants, is no doubt due to the catastrophic state of its medical-clinical system caused mainly by the debt crisis from on. next we pass to a group of countries that reacted late and not systematically, applying the various measures in a haphazard way and only to part of the population. here are some of them with their numbers of inhabitants in million, cumulated numbers of confirmed cases and numbers of fatalities: the relatively low number of deaths in germany reflects mainly a sufficient medical-clinical system that could readily adapt itself to the epidemic. the opposite was true in france. there, about , hospital beds had been eliminated in the period between and . an arbitrary strict "confinement" not determined by epidemiologic reasoning was imposed on the th march. finally there are countries that decided to do nothing, at least for a long while. their motivation, or pretext, was above all a belief in herd immunity (sects. this overview of strategies confirms that, as said in the introduction, the results depend indeed heavily on the state of public health. note that nowadays in every language of the world the concept "public health" is designated by a literal translation or a slight modification of this expression. for instance in danish it is "folkesundhed", that is, "health of the people". in this second part we shall sketch the scientific and in particular mathematical principles involved in the study of successive stages of the pandemics. in short: sect. : discovery of the new virus, basic properties, testing for its presence in a person. and : data on the evolution of covid- in a population. : attempts at analysing mathematically and predicting such an evolution by representing it by an epidemic curve. : the analogous for a representation by a compartmental model. : trying to stop the epidemic by a vaccine. : what to learn and what to do? after the often-depicted outbreak in late december of cases of pneumonia of unknown aetiology around wuhan, in the course of january chinese scientists identified a new virus as the pathogen. they followed the usual procedures, i.e., they determined the load of common respiratory pathogens in the patients. they found none of them in abundance. they suspected sars-cov but could not find it either. then they investigated all kinds of viral load that had a slight similarity (coincidence in a number of genomes) with sars-cov and detected a novel virus which displayed abundant virions in respiratory specimens from patients. electron microscopy and mathematical pattern analysis [mum, pev] showed that it belongs to the same species as sars-cov- and mers-cov (sect. ); hence the name sars-cov- . starting with this work in china a large number of publications about the peculiar properties of the pathogen and the ways it is acting have appeared. on the virological side its genetic sequence was determined. the new virus is believed to have zoonotic origins but human to human infection was rapidly established. the combination of sars and influenza features, that is intensive respiratory inhibition of patients and rapid transmission, make covid- , the disease caused by sars-cov- , particularly dangerous. for further work see [and] . in the clinical context, several periods in the evolution of a case were determined (see their definition in [kpp, sect. . ]): the median incubation period is . days; the mean latency period is . days, i.e., in general the infectious period starts indeed before the prodromal phase. we have discussed the implications in sect. by comparison with ebola. the mean length of the infectious period is days for mild and asymptomatic cases; for severe and critical cases this period lasts on the average days and ends only by recovery or death. the manifold applications to the control of the pandemic of both their virological and their clinical characteristics will appear in sects. , , and . their study is still active and may even reverse former results; this happened for example recently about so-called cross-immunities. however, in this article we shall only treat applications to the basic element of well-designed control strategies, namely testing for infections. the first step of a test programme is to define the target population. who will be tested? subjects who had a contact with infected people? or those who complain about symptoms? or everybody coming from a region where cases exist? see the example of vietnam in sect. . next, what will be the objective? to discover the presence of the virus or that of some kind of antibodies? depending on the objective there exist virological and serological tests. the usual virological test is called the pcr-(polymerase chain reaction) test. dozens of serologic tests of varying quality have been and still are developed and even offered in some countries to the general public. recall that the characterization of a test with a given target population and a given objective is a classical subject of clinical epidemiology [kpp, sect. . ] . coming back to the fundamental role of testing in control strategies we only remark that in poor countries or in rich countries with inattentive public health officials, the target population was often determined by the shortage of test kits and by the influence of institutions that required them for themselves. this is classical medical statistics, which gives for a specific disease the number of cases and deaths together with the when and where and a few additional data such as sex, age and sometimes profession of the subjects. in principle the methods for finding the number of confirmed cases and of fatalities by covid- are the same as for any other disease. they fluctuate widely between countries. both the diagnosis of a case of a disease and the description of the cause of a death may be relatively correct or most unreliable. in particular finding a correct diagnosis for somebody who complains about acute health problems depends very much on the local contact tracing methods and on the state of the clinical-medical system. an additional difficulty arises form the existence of asymptomatic forms of the disease, that is, subjects infected by sars-cov- who display no symptoms. in sect. we have mentioned vietnam, which uses its normal demographic and health information systems [kkr] . it includes in its statistics asymptomatic cases found by contact tracing. other countries obtain their morbidity and mortality data from a "health reporting system". such a system is partly based on sampling methods from various sources, for example hospitals and local health offices. in germany the robert koch-institute, a central institute mainly devoted to infectious diseases, reports on the results for covid- . in the usa the johns hopkins university plays a similar role. still other countries use data from health insurance offices. however, many countries have neither a health information system nor a health reporting system, or they do not use it for covid- . a host of alternative methods is being employed. for example france counts only hospitalized confirmed cases and only deaths which happen in a hospital or in a retirement home that is connected with a medical structure. summing up we may say that morbidity data and to a lesser degree mortality data for covid- that one finds in various periodic publications are fairly unreliable, with very few exceptions. the sources are not always clearly indicated. an important alternative idea is to compare the present situation with that in years past. speaking again naïvely we assume that the present higher case frequencies and death tolls, and only these, are the result of covid- . given the diagnostic difficulties mentioned above this idea is mainly applied to fatalities and hardly to nonlethal cases. thus in the method of "excess mortality" we only measure how many more deaths by any cause happened this year than in the corresponding period in the past. for the uk we have for instance quoted in sect. the figure of , deaths up to the st june as supplied by the national health service. by contrast the national statistical office advanced about , deaths as excess mortality! fig. estimated number of infections on lock-down day and excess mortality for selected countries. reproduced from [fit] , permission granted by finally, here is an interesting idea based on the most classical form of a statistical-mathematical model. a graphic in the paper [fit] (see figure ) shows for every one of selected countries the point in the plane whose coordinates are, respectively, the estimated number of infections per million inhabitants on lockdown day and the excess mortality. a short glance convinces us that they are positively correlated. a simple regression analysis based on this graphic would allow us to estimate one of these values by the other one for any other country, too. it goes in several directions beyond classical health statistics, all of them relevant to covid- , too. firstly, sample surveys are conducted instead of using the data from the entire "target population". they have for example been used to study the influence of social factors on the evolution of various aspects of the disease. in particular the factor "to be an immigrant or to descend from them" was thoroughly investigated in some countries. secondly, more types of data about cases and deaths are collected, for example about morbidity and mortality by age groups. thirdly, data sets are not only being registered and perhaps published but also transformed and interpreted in various ways. here, standardization is the best-known procedure. a fictitious example would be the number of fatalities by covid- in denmark if denmark had the same age structure as vietnam and in each age group it had the same covid- mortality as in the same age group in vietnam. in sect. we shall meet statistical-mathematical models as a basic mathematical tool in developing a preventive treatment of covid- . with their help one studies in a clinical trial the influence of various factors on some outcome variable e of interest. here the idea of "controlling" for the influence of another factor, which might be a "confounder" in the study of the action of e , plays a role. it looks as if most demographers on the one hand, and most clinical epidemiologists on the other, ignore that the mathematical procedure of standardizing is the same as that of controlling for a confounder [kpp, lesson ] . a mathematician will not be astonished, though! we have mentioned this classical concept in sect. ; see [kpp, sect. . ]. let c be an epidemic, v a geographical region, t a moment of time which may be that of the first case of c in v , and f(t) for t ≥ t the number of observed and reported cases of c that had declared themselves in v before or at the instant t . then f is called the epidemic curve of c in v . in particular it needs to be said whether unconfirmed cases are included or not. measuring f(t) as the time t goes along is the task of the relevant demographic services (sects. and ). this process is therefore subject to all the deficiencies listed there. to get some knowledge about f for various regions v is of course one of the main concerns of the population of a country invaded by c . such knowledge is equally vital for health authorities who attempt to control c . however, much more knowledge is desirable. what can we learn about the mechanism of c by observing f(t) ? this was already the subject of the papers described in [fin] ; see sect. . in particular, is there a way to predict aspects of the future evolution of f , having observed the values f(t) for a while? answers to these questions are generally given by modelling f , that is by making certain assumptions about its shape and by estimating certain parameters in it. a very large number of papers was published about this issue. some of them use extrapolation methods known from mathematical economy. a recent survey on basic ideas and techniques can be found in [krm] where a model is described in terms of an integro-differential equation. we shall restrict ourselves to a discussion of an application, namely the so-called basic reproduction number r . it appears constantly in popular publications. to define it let us look at a subject s that is infected at a time t* ≥ t . let µ(s, t*) be the number of all subjects infected by s after t* in the form of secondary, tertiary etc. infections. then r is the average of µ(s, t*) over all s . thus it depends on t*. it is precisely this dependence in which people are interested: a value less than is looked upon as predictor of the extinction of c after t*. in the case c = covid- , values as high as . had been estimated in the beginning, that is, for t* close to the time of the first outbreak of c. the article [sia] presents an interesting factorisation of r in order to compare different approaches to control the size of it. we have sketched their historical origin in sect. . we distinguished between two ways of mathematically modelling the evolution of an epidemic. models of the first kind (sect. ) represent the temporal evolution of the number of subjects in a certain state, for instance the state "to be infected". by contrast, compartmental models also represent changes of this state at some moments in the form of transitions of a subject from one compartment to another one. the sir-model, which we designated in sect. as "intensively studied in the s", is particularly simple and has served as a paragon for many others, in particular for those applied to covid- . it involves three compartments: s are the susceptible, not yet infected subjects, i the infected ones, and r consists of subjects removed by recovery with immunity or death. the transitions between compartments are described by differential equations for the numbers s(t), i(t) and r(t) of subjects in the compartments as a function of time t . they involve certain parameters such as transition probabilities from one compartment to another one. under various assumptions the resulting system of differential equations for s , i and r can be solved explicitly or numerically. a first important application is to estimate the basic reproduction number r defined in sect. . it can be expressed by the basic parameters. secondly, it turns out that the limit s∞ of s(t) for t →∞ is strictly positive, which means that a certain part of the population will never be infected. this led to the concept of herd immunity, which, however, gave rise to much confusion among people who thought they had something to say about the matter. after the outbreak of covid- many more involved compartmental models were defined and analysed. their parameters represented among other features the underlying control strategy to be used. there was for instance the "do nothing" strategy and also the "mitigation" strategy, which consisted of the less stringent components of the "surveillancecontainment strategy" defined in sect. . in the much discussed paper [fer] neil ferguson and collaborators described the shape of the function i, that is the number of infected subjects, for the "do nothing" strategy. from the value on it increases, reaches a maximum, decreases and finally reaches at a certain moment thappy . this had apparently motivated the countries uk, usa, sweden and brazil to adopt this strategy for too long, ignoring that ferguson predicted (see figure ) about , deaths caused by the epidemic in the uk and . million in the usa before extinction at the moment thappy. expected deaths caused by the epidemic for the do-nothing strategy, reproduced from [fer] with permission of school of public health, imperial college london at present compartmental models play hardly any practical role, mainly because they contain too many unknown parameters. some parameters such as infectivity are estimated with the help of a model of the epidemic curve, which seems to be a not very successful detour. it will hardly surprise that several pharmacological companies have started a run for developing curative and preventive treatments of various ailments, which sars-cov- may inflict on a person. up to now no curative treatment was found. there are only the wellknown methods to be used in the treatment of non-specific aspects of a case such as reducing pain, facilitate breathing or shorten the time to recovery by a antiviral drug. we shall therefore restrict ourselves to preventive treatments, that is, to immunizations. the objective of an immunization by a vaccine against a covid- connected health deficiency needs to be defined in the same way as for any other infectious disease. first the target population needs to be determined: whom do we intend to protect? next, what are the health deficiencies we want to prevent? for how long is the preventive effect to last? this is a particularly important aspect of the vaccine but is usually suppressed when a new one is announced. for instance the measles vaccination remains lifelong active in most subjects. for covid- the company which tries to develop the vaccine may be satisfied with a few months, hoping that sars-cov- will have disappeared after that. finally the efficacy needs to be found, which represents the part of the target population actually protected. it may also be defined in epidemiologic terms by regarding as "exposed" all subjects that had not obtained the treatment. then the efficacy is the "aetiological fraction among the exposed subjects". nowadays there is general agreement that the process of developing a vaccine against an infectious disease needs to run along a well-defined common line [kpp, lesson , and hal] . this ought to hold for covid- , too, and we shall therefore recall it here. first, one or several substances are selected which, for some reasons whatsoever, usually virological ones, look like possible candidates for a vaccine. each of them needs to be submitted to a "clinical trial" in order to explore its most important properties. such a clinical trial consists of three "phases" i, ii and iii. phase i deals with various mainly pharmacologic aspects such as side effects for various possible dosages. statistical-mathematical models are the essential tools of the phases ii and iii. phase ii aims at providing a first idea of the efficacy of the selected vaccine. thus a relatively small target population is built artificially. here two basic problems arise. the first is the definition of the outcome variable of interest. often only the "immunogenicity" is being studied, which means the formation of antibodies, but not protection against the disease. it is a particularly complex and manifold problem in the case of covid- . secondly, the target population needs to include among the vaccinated subjects a sufficient number of people who would attract the disease when not vaccinated. since covid- morbidity in the entire population of a country is small, such a group must be constructed by "challenge", that is, by infecting its members artificially. they are usually volunteers and their risk of dying is small except in the age groups where the lethality by the disease is high, that is, in the case of covid- , for old people. faced with this ethical problem the usa used, for various previous infectious diseases, prison inmates whose terms were shortened as a reward. there was a time when vietnam, while developing a certain vaccine, sent its samples for the phase ii trial to the usa to be tested in this way because vietnamese ethical standards forbade all kinds of challenge. there are usually several phase ii trials in order to select the potential vaccine to be finally studied in a phase iii trial. this is a field trial in the sense that a sample of subjects is drawn from the entire population of interest, for instance from among all inhabitants of a country within a certain age group. the outcome variable is not immunogenicity but protection against the disease in the sense of the desired efficacy. the size of the sample is determined beforehand by the precision of the intended estimate of the efficacy. as noted above the decision about the duration of the trial is a crucial element. if high efficacy during the first two weeks after vaccination is considered sufficient, the trial may be stopped after two weeks; this philosophy underlies the vaccinations against the seasonal influenza. if we are interested in its efficacy during the first ten years after vaccination, it must last ten years. this has, in addition to other problems, caused the long delay in developing an ebola vaccine (end of sect. ). we hope that it will not be glossed over by those who are trying to sell a covid- vaccine very soon. the pandemic has functioned like a magnifying glass. in some places, it showed a basically well-functioning society. in other places it revealed scandals and intolerable social inequalities. in particular it reflected the state of a country's public health system. the present article aimed at describing the role of mathematics in the pandemic. as said above there are two parts to this "outlook". let us take up the first one, namely: what can be learnt from the epidemic? in sect. we gave an overview of the main branches of mathematics that play a role. then the sects. - sketched the most frequent applications; their titles and their order correspond vaguely to the branches of mathematics concerned. thus there were mathematical pattern analysis in laboratory work and statistical-mathematical models in judging the quality of tests; demographic methods in the collection of data; different ways to model the evolution of the pandemic mathematically; and clinical epidemiology in attempts to develop a vaccine. in this way the article aimed at clarifying the potential role of mathematics in making decisions. on the one hand it turned out that in practise the role of epidemic curve or compartmental models is much more restricted than advertised in many publications. decisions based on them may even have disastrous consequences, for instance those based on the mathematical concept of herd immunity. thus blind trust in mathematical arguments is unjustified. on the other hand denying the existence of a valid mathematicalscientific foundation for a control strategy is just as detrimental. it was done in denmark with the "tracing and lock-down" strategy by a report of an "expert group" of health academics and officials, which reflected the interests of medical, industrial and governmental circles. this comment leads us to the second part of our "outlook", namely: what to do in the future? the authors of the present article started it in early may by "since the covid- pandemic is not over ...". while we are finally finishing our work in the middle of july, it is still not over! it is even very active but has taken a largely different form. hence it seems natural to analyse its present characteristics in the light of the facts we have described in the sections - above and to ask ourselves: which lessons can we draw regarding the control strategies to be applied now? covid- does no longer surge from a single source. it reappears in small or large regions of many parts of the world, which may be of various forms and extensions: a single home for the elderly in france, two districts in germany, a large city like beijing, an entire province in spain, or a whole country like new zealand. we shall call them "nests" to distinguish them from "clusters", which denote certain discrete sets of people. a precise follow-up of the evolution of cases in these nests meets with the manifold difficulties explained in sects. and and will not be repeated here. a first natural question to ask is, then: why do "active" nests persist and reappear? sect. presented three components of successful control strategies: contact tracing; lock-down; masks. while contact tracing continues reluctantly, lock-down and wearing masks were widely abandoned, often as a result of governmental policies seeking popularity. next, what should be done? in the sections , and we have explained, using in particular mathematical arguments, in how far the strategies of control treated there suffer from serious drawbacks. this leaves us with the combination of two measures: inside a nest a rigorous lock-down such as social distancing and preventing larger assemblies of people; at its borders: closing them or only allowing passage when combined with quarantine. for example new zealand regarded as a single nest has taken such rigorous measures. as a result there are now no new cases, except two cases around the th july in "managed isolation facilities". other nests will act similarly, we hope. the proximal origin of sars-cov- the first epidemic model: a historical note on p.d. en'ko daniel bernoulli's epidemiological model revisited impact of nonpharmaceutical interventions (npis) to reduce covid- mortality and healthcare demand. mrc centre for global infectious disease analysis john brownlee and the measurement of infectiousness: an historical study in epidemic theory the risks of lifting lockdowns prematurely are very large design and analysis of vaccine studies principles of health information systems in developing countries key to public health a novel deterministic forecast model for covid- epidemic based on a single ordinary integro-differential equation pattern theory. the stochastic analysis of real-world signals an introduction to bioinformatics algorithms alternative corona strategy: we can beat the infection down for the count with quarantine and tracing of infectors the authors: bernhelm booß-bavnbek born in , studied mathematics from to at bonn university. research, teaching and practical work first in econometrics and operations research and then in geometric analysis and membrane processes of cell physiology professor at several universities in europe and outside; research, teaching and practical work first in mathematics and then in epidemiology and public health. much of this was done in developing countries key: cord- -ztdhgxno authors: czernin, johannes title: the impact of covid- on the health-care workforce: from heroes to zeroes? date: - - journal: j nucl med doi: . /jnumed. . sha: doc_id: cord_uid: ztdhgxno nan ) reaches far beyond the business of nuclear medicine and radiology ( ) ( ) ( ) . the u.s. health-care economy was projected to suffer dramatic financial losses totaling more than $ billion just for the mo from march through june ( ) . mass layoffs frequently mitigate the financial stresses of industries. the health-care industry is no exception. job losses will be most extensive and painful among the low-income and minority populations that also have the highest covid- -associated infection and mortality rates. these demographic and economic consequences have not changed much since the spanish flu, which also affected low-income populations most gravely. hospitals that were already financially stressed before the pandemic began are at highest risk of financial collapse now. these smaller, rural centers provide underserved populations with critical access to essential medical care. many of these facilities will not survive covid- , thus further limiting medical care to already underserved populations. larger systems will merge with smaller hospitals, and some small clinics will simply disappear. by the end of april , the ambulatory health-care workforce had dropped by . million (or . %), as reported by the bureau of labor statistics. a considerable number of jobs will be regained after an unknown recovery period. however, hospitals cannot spend money they do not have. the government initiated the coronavirus aid, relief, and economic security act, which delivered nearly instantaneous but insufficient financial relief. much more needs to be done. the health-care workforce much appreciates flyovers, tickertape parades, shout-outs of thank-you, symphonic fanfare, clapping, banging of pots and pans, and many other acts of love that provide a morale boost. but what comes next? who will help the heroes when their finances drop to zero? who will help them when they lose not only jobs but also health insurance? in their current analysis, logiudice et al. ( ) from memorial sloan kettering state that over the long term, ''once fear has subsided, unemployment and insurance coverage will play an important and longer-lasting role.'' they quote predictions that ''a % unemployment rate will translate to an % decrease in the number of people covered by employer-sponsored insurance plans, or . million people.'' in a less optimistic model, the outcomes are even more sobering. the changes in insurance coverage, or in other words, in payer mix, will have a detrimental impact on hospitalsystem balance sheets, which in turn may lead to further furloughs, salary freezes, and layoffs. logiudice et al. point out that the main source of hospital expenses is staff compensation. obviously, hospitals have little choice but to cut major expenses when the funds supporting salaries are no longer available. the memorial sloan kettering group concludes correctly that in the long run, ''companies cannot save their way out of a crisis.'' to succeed, health-care systems need to continue to grow and innovate to support job growth rather than contract. in the interim, because hospitals will be unable to maintain their workforce, governments need to step in to mitigate the devastating job losses in health care. bailouts have saved the financial sector, the car industry, mortgage lenders, and many more throughout history. the health-care economy needs a major bailout to ensure that hospitals remain solvent, that low-and medium-income workers are not losing their jobs and insurance, and that high-quality health care can be guaranteed. overcoming the covid- crisis and planning for the future nuclear medicine operations in the times of covid- : strategies, precautions, and experiences a conversation between johnese spisso and johannes czernin hospitals and health systems face unprecedented financial pressures due to covid- -hospitals-and-health-systems-face-unprecedented-financial-pressures-due immediate open access: creative commons attribution . international license (cc by) allows users to share and adapt with attribution, excluding materials credited to previous publications key: cord- -m j us e authors: herman, joanna; patel, dipti title: advising the traveller date: - - journal: medicine (abingdon) doi: . /j.mpmed. . . sha: doc_id: cord_uid: m j us e global travel continues to increase, particularly to tropical destinations that have different health risks from those encountered closer to home. currently, over a billion people travel annually, with over million visits made from the uk. seeking pre-travel advice should be an essential part of any trip for a traveller. the key elements of pre-travel advice are health risk assessment, health promotion and risk management; this involves advice on prevention of malaria, travellers' diarrhoea, sexually transmitted infections and accidents, as well as appropriate vaccinations. higher risk groups of travellers, such as those visiting friends and relatives, those with co-morbidities, pregnant women and very young or elderly individuals, particularly need to be targeted. international travel continues to increase, with > billion travellers worldwide now crossing international borders, and > million visits made from the uk each year. although many travellers from the uk visit europe and north america, there has been an increase in travel to tropical destinations. this places travellers at risk of a variety of travel-related conditions, such as malaria, dengue and other tropical or vaccine-preventable infections, many of which are rarely, if ever, encountered at home. travellers are therefore an important group to target owing to their movement, the risk of adverse health outcomes abroad and the possibility of importation or exportation of infectious diseases. however, estimation of disease risk in travellers has proved elusive, with difficulty ascertaining precise data on both numbers travelling to specific locations and incidence of illness in travellers. despite their limitations, frequently quoted studies estimate the overall risk of morbidity from illness or injury to be between % and %. although most illnesses tend to be self-limiting, approximately % of travellers require a doctor's attention, % require hospitalization while abroad, and many travellers require medical care on returning home. however, the most likely causes of mortality in travellers are accidental injury (e.g. road traffic accident (rta), drowning) or a cardiovascular event, rather than an infectious disease, which accounts for only e % of deaths. many travel-related illnesses are preventable by taking sensible precautionary measures, and, for some diseases, by having the appropriate vaccinations and taking chemoprophylactic medications. in the uk, pre-travel advice is given in the primary care setting or at specialized travel clinics, and is usually nurseled. access to pre-travel healthcare surveys of travellers visiting less-developed countries indicate that approximately % seek pre-travel health advice. use of pretravel healthcare is low because of a lack of concern about health issues related to travel; primary care and the internet were the most common sources of information. the likelihood of seeking pre-travel advice varies in different groups of travellers, with migrants who return to their country of origin to visit friends and relatives (vfrs) being the least likely to seek advice or take precautionary measures. this group has a disproportionately increased risk of acquiring the more common tropical infections compared with other travellers, and they should be targeted specifically for pre-travel advice. the travel clinic consultation the key features of a pre-travel consultation are health risk assessment, and health promotion with risk management (table ) . risk of infection varies according to the area to be visited, endemicity of diseases, nature of travel (holiday, business, backpacker, vfr), type of accommodation, anticipated activities and duration of trip. it also varies according to the health status key points c there has been an increase in travel to tropical destinations, with subsequent exposure of travellers to malaria, dengue and other tropical and vaccine-preventable infections c the most likely causes of mortality in travellers are accidental injury or a cardiovascular event, rather than an infectious disease c malaria is one of the most common and serious causes of fever in travellers the key features of a pre-travel consultation are health risk assessment, and health promotion with risk management c higher risk groups of travellers include those visiting friends and relatives, those with co-morbidities, pregnant women and very young or elderly travellers of the traveller: their medical conditions, current medications, allergies and immunization history. most ( e %) travellers to the tropics undertake short-term visits (< month). the remaining e % spend long periods abroad, either travelling or working (e.g. backpackers, missionaries, volunteer workers, placements with the armed forces), or on repeated short-term visits (e.g. businessmen, airline crews). these groups incur different risks and exposures, depending on both individual behaviour and environment, with the long-term traveller at greater risk of acquiring infections endemic in the local population they are visiting. there is also a risk difference between the sexes, with male travellers at greater risk of most disease acquisition, except for travellers' diarrhoea, which is more frequent in female travellers. risk also varies according to the geographical area visited. travellers to africa have the highest rate of all-cause morbidity and account for the greatest number of cases of plasmodium falciparum malaria. the highest risk of plasmodium vivax and diarrhoeal illness is in travellers to south asia, while cutaneous leishmaniasis is most common in visitors to latin america. furthermore, risk within a country can differ; for example, malaria risk is negligible in nairobi compared with a significant risk on the kenyan coast. travel medicine is dynamic, and both travellers and physicians should be aware of, and respond to, changes in epidemiology of potential infections, including the occurrence of outbreaks. recent outbreaks (e.g ebola, zika, yellow fever, middle east respiratory syndrome), and wide media coverage have alerted travellers to the potential risk of previously rarely encountered tropical infections. however, although the risk of acquiring these infections is low for most travellers, they can have a role in spread of disease, particularly vfrs. information about outbreaks can be found on various websites including those of the world health organization, the national travel health network and centre, and the centers for disease control and prevention ( table ). these websites also offer valuable information for vaccine recommendations, although regional prevalence of specific disease can be difficult to obtain. finally, it is important to remember that non-tropical infections account more commonly for the infections that present in returned travellers. health promotion and risk management many travel consultations focus on vaccinations, but these can be among the least cost-effective preventive measures in travellers as vaccine-preventable diseases account for < % of travelassociated morbidity. the main priorities should be given to health problems that are common, preventable, treatable and serious or potentially fatal. these include malaria, travellers' diarrhoea, sexually transmitted infections (stis) and rtas. health hazards that are rare (e.g. cholera, japanese encephalitis, parasitic infections) should be put into perspective and discussed, based on the individual traveller's risk profile. current best practice emphasizes the need for a patientcentred approach and shared decision-making. therefore, for each risk, the travel medicine practitioner must balance the need for prophylaxis against the realistic risk of infection, and the likelihood of adherence to preventive measures by the traveller. the latter depends on a number of factors including perception of risk, concerns about available preventive measures and treatments, and preferred risk management options. travellers should know that no intervention is fully protective. malaria is one of the most common and serious causes of fever in travellers, occurring while abroad or on return (see malaria on pages e of this issue). the risk of malaria is greatest in sub-saharan africa (particularly west africa), intermediate in south asia (india), and lowest in central and south america and south-east asia. however, the risk for acquiring malaria can vary widely from traveller to traveller, from region to region and within countries. those at particular risk of disease acquisition are long-term vfr travellers, while those at risk of severe disease are pregnant women, travellers with complex co-morbidities and elderly individuals. prevention of infection involves understanding the disease process and the 'abcd' of malaria: awareness of risk bite prevention from nocturnal anopheles spp. mosquitoes chemoprophylaxis prompt diagnosis of infection. health risk assessment bite prevention measures include use of insect repellent such as deet, covering up during the highest risk time periods (dusk to dawn), and sleeping under an insecticide-impregnated mosquito net if enclosed and screened accommodation is not available. the choice of chemoprophylaxis depends on the type of malaria that is endemic in the region being visited, and whether drug resistance (usually chloroquine resistance of p. falciparum) is present. it also depends on individual factors and preferences for the different drug regimens, such as dosing frequency (e.g. weekly for mefloquine, daily for doxycycline or atovaquoneeproguanil), and affordability. for countries with a high prevalence of chloroquine-resistant p. falciparum, mefloquine, doxycycline or atovaquoneeproguanil can be taken. for the limited areas with little chloroquine resistance, chloroquine plus proguanil should be taken, and in areas without resistance, chloroquine alone can be used. practitioners should be aware of the adverse effects of and contraindications to all the antimalarials. for detailed information, including adverse effects and special situations such as pregnancy, see the uk malaria guidelines at: www.gov.uk/government/publications/malaria-prevention-guide lines-for-travellers-from-the-uk. travellers should be advised that although malaria prevention methods are highly effective, they do not provide % protection, and they should seek immediate medical attention if they have symptoms suggestive of infection. diarrhoea is the most common illness affecting travellers to developing countries, with e % being affected (see diarrhoea in travellers on pages e of this issue). it can cause significant morbidity and can result in loss of travel time, amendment of itineraries and medical encounters, including hospitalization. travellers diarrhoea is usually non-bloody, watery, may be frequent and explosive, but has minimal or no fever. table prevention of malaria (the 'abc' of malaria prevention) awareness of risk mefloquine https://www.gov.uk/government/publications/malaria-prevention-guidelines-for-travellers-from-the-uk a a e % concentration is usually recommended and is safe for all travellers > months of age; manufacturer's guidelines for use should be followed. b before prescribing an antimalarial agent, the prevalence, species and potential resistance of malaria found in the travel destination must be determined, as should any medical contraindications. the most common causal organisms are bacteria, particularly enterotoxigenic escherichia coli, enteroaggregative e. coli, salmonella spp., campylobacter and shigella, but viruses (rotavirus, noroviruses) and protozoa (giardia lamblia, cryptosporidium spp.) can also be the cause. rarer, but more serious, are the enteric fevers (typhoid, paratyphoid), which have the same risk factors as other gastrointestinal infections. travellers can be concerned about the risk of cholera, but apart from a few specific circumstances (e.g. working in refugee camps), this poses little threat to most travellers. the travel health practitioner should discuss both prevention and self-treatment. prevention advice should focus on food and water hygiene, and it is useful to emphasize the 'boil it, cook it, peel it or forget it' approach to eating while abroad. the importance of hand hygiene (washing, sanitizer gels) should also be stressed; however it is not always easy to follow this advice, and illness can still occur despite adhering to it. prophylaxis with antibiotics is recommended in limited circumstances (see diarrhoea in travellers on pages e of this issue). guidelines on self-treatment should stress the importance of maintaining hydration and advise when to control symptoms with an antimotility agent, and when to treat illness with a short course of antibiotics. mild diarrhoea should only require increased hydration and possibly an antimotility agent (e.g. loperamide), but antibiotics may be advised for moderate diarrhoea and should be used if it is severe. self-administered fluoroquinolone antibiotics (ciprofloxacin, levofloxacin) or a macrolide (e.g. azithromycin) significantly reduce the duration and severity of symptoms in acute watery diarrhoea. a single dose of ciprofloxacin or levofloxacin can be sufficient in many cases if taken soon after the onset of symptoms, but treatment can be continued for up to days if diarrhoea persists. in areas where fluoroquinolone-resistant campylobacter is widespread (south and south-east asia), azithromycin is the drug of choice. however, owing to its proarrhythmogenic properties, it should be avoided in elderly travellers with cardiovascular disease. for moderate diarrhoea, the combination of antibiotic and loperamide is more effective in reducing both the duration and severity of symptoms compared with antibiotics alone. however, an antimotility agent is not advised if the diarrhoea is dysenteric (i.e. bloody stool with abdominal pain) or if the person is febrile. packaged oral rehydration salts (or a self-made simple rehydration solution) can be used to maintain hydration in infants, young children and the elderly. medical advice should be sought abroad if symptoms continue or if the diarrhoea is dysenteric. travellers with persistent diarrhoea on return from their trip should undergo further investigations, particularly looking for protozoan infection with giardia intestinalis or cryptosporidium. travellers and tourists often engage in risky behaviour when abroad, and may have unprotected sexual intercourse with other travellers or locals from high-risk populations. studies have found that e % of people with a confirmed sti attending a genitourinary medicine clinic reported a new partner while away, with e % not using or inconsistently using condoms. the risk of transmission of stis and hiv should be discussed with all travellers who seek pre-travel advice, as the risk can be virtually eliminated by practising safer sex. raising awareness of these sensitive issues is an important part of the travel health consultation, although some practitioners find them difficult to address. less common risk factors for hiv infection include invasive medical treatment and transfusion with contaminated blood, which are of particular importance in sub-saharan africa, where the seroprevalence of hiv can approach %. vaccinations (table ) vaccine-preventable diseases are uncommon to rare in travellers (usually < case per overseas visits). the decision to vaccinate a traveller is based on the epidemiology and risk of the disease, the effectiveness of the vaccine, the risk of vaccineassociated adverse events, the individual's underlying health, the cost of vaccination and the ability to employ other diseasepreventing measures. the three main reasons for vaccinating travellers are: recommended as part of routine healthcare required by the destination country recommended because of travel-related risk. routine vaccinations: the pre-travel visit is an ideal time to make sure that travellers are up to date with routinely recommended vaccines, such as those against measles, mumps, rubella, tetanus, diphtheria, pertussis and polio. it also provides an opportunity to ensure that the traveller is up to date with any additional vaccines that might be recommended as a result of their work, lifestyle choice or underlying health problems. the recent increase in cases of measles in high-income countries emphasizes the need both to protect travellers and the destination and receiving countries. yellow fever vaccine is recommended for those travelling to areas where there is a risk of yellow fever transmission (tropical parts of africa, south america, eastern panama in central america, trinidad in the caribbean). however, as a condition of entry, some countries require an international certificate of vaccination or prophylaxis (icvp) against yellow fever as proof of vaccination against the infection. before administering yellow fever vaccine, consideration must be given to the viscerotropic and neurological severe adverse events associated with the vaccine, which have been recognized over the past decade. although these adverse events are rare ( . e . events per , doses), they are more common in those aged years and older. the ihr ( ) have also recently been applied to poliovirus. in , an emergency committee of the world health organization declared that, under ihr ( ), the international spread of poliovirus represented a public health emergency of international concern, and recommendations were made for countries reporting cases and/or exporting the virus to reduce the potential for spread. these measures included a requirement for an icvp for polio vaccine for some groups of travellers as a condition of exit from a country reporting and/or exporting cases of polio. there are occasionally specific vaccination requirements for entry into countries. for example, saudi arabia requires all pilgrims and seasonal workers travelling for the hajj or umrah to show proof of having been given the quadrivalent meningococcal vaccine as a condition for granting a visa. immunization for travel-related risk: once the practitioner has taken account of the disease epidemiology in the destination region, the mode of acquisition (e.g. food-, water-or vectorborne) and the non-vaccine preventive measures available, they can then determine the likely risk of significant disease, and the need for vaccination. most travellers can be safely vaccinated, although in some, vaccination can be contraindicated or should be deferred. caution is required for travellers who are severely immunosuppressed, for whom live vaccines are contraindicated and the efficacy of inactivated vaccines may be reduced. for travellers living with hiv, guidelines from the british hiv association (www.bhiva.org/vaccination-guidelines.aspx) should be consulted. live vaccines should generally be avoided, and must not be given to hiv-positive adults with cd cell counts < cells/ microlitre. however, when travel is unavoidable, and risk of infection outweighs risk of vaccination, some live vaccines can be given to those who are asymptomatic with a stable cd count > cells/microlitre and a suppressed viral load. all travellers should be informed that no vaccine is % effective and that appropriate precautionary measures should still be taken. vaccines administered in the uk for age-specific routine healthcare a accidents, safety and security approximately e % of traveller deaths are to the result of injuries. unfamiliar environments, cultural and language differences, less stringent health and safety standards, increased risktaking behaviour and lack of accessibility or adequacy of emergency care all contribute. most injury deaths are caused by rtas, and travellers should be aware of the risks of being a pedestrian, passenger or driver in a foreign country, particularly when unfamiliar with local road systems. travellers should always use seatbelts and should never drive after alcohol consumption. other causes of injuries include watersports, adventure activities and crime. travellers can be perceived as wealthy, naive, inexperienced or unfamiliar with the environment and customs, and are therefore often targets for criminals. the need for moderation of alcohol consumption and avoidance of illicit drug use must be addressed because of its tendency to promote risk-taking behaviour, including unsafe sexual practices, in addition to accidents. travellers from the uk should consult the foreign and commonwealth office country page ( table ) to determine if there are any safety or travel restrictions for their destination. travellers with co-morbidities travellers with underlying medical conditions can be at increased risk of adverse outcomes both during and after travel, and therefore require careful evaluation. in addition to the standard travel-related risks, the stability of their condition(s) and the impact of travel, the overseas environment, endemic diseases, and vaccinations and other preventive measures on their underlying diseases or medication must be evaluated. the adequacy of local medical facilities and the availability of medication and medical equipment also need consideration. careful counselling on what to do in the event of illness abroad, medication management, use of self-treatment measures and when to seek medical assistance is key. giving the traveller a summary of their medical record, including a medication list, can also be helpful. in the case of medication, regulations on importing or transporting medicines at their destination may also need to be checked. although there are few absolute contraindications to travel, some airlines may refuse to transport individuals with unstable or acute medical conditions. therefore early preparation, liaison with their specialist and comprehensive travel insurance that will cover their underlying medical condition(s), in addition to their expected activities, is essential. disease-specific resources are available and provide additional guidance for travellers on healthcare facilities abroad and specialist travel insurance. in summary, most travel-related illness is avoidable if the necessary preventive measures are taken and the appropriate high-risk groups are targeted for pre-travel advice. however, some tropical infections can manifest only weeks to months after returning home. to test your knowledge based on the article you have just read, please complete the questions below. the answers can be found at the end of the issue or online here. a -year-old man attended for travel health advice. he planned to travel to brazil for work in weeks' time. he would be travelling to the amazon starting in manaus for weeks, and then he would spend weeks in rio, although his plans were subject to change. he was well, but was hiv-positive, with a cd count of cells/microlitre and a suppressed plasma hiv- rna load. he was on antiretroviral therapy. he was up to date with his childhood vaccinations, but was non-immune to measles. he had never had any travel vaccinations. what is the most appropriate vaccination advice for this traveller? a. travel vaccines are contraindicated b. replicating (live) vaccines are contraindicated c. oral typhoid vaccine is recommended d. measles/mumps/rubella vaccine is recommended e. yellow fever vaccine is contraindicated a -year-old woman was planning to take her -month-old baby boy to visit her parents in accra, ghana, in weeks' time, staying for weeks. both were fit and well, and the child was up to date with his vaccinations. the mother was weeks' pregnant and was requesting advice about malaria. what advice is the most appropriate advice with regard to malaria prevention for mother and child? a. the mother should be advised % n,n-diethyl-metatoluamide (deet) is contraindicated for the child because of his age b. chloroquine plus proguanil is suitable for chemoprophylaxis for both mother and child c. the mother should be advised that bite prevention measures are particularly important during peak aedes mosquito biting times d. mefloquine is suitable for chemoprophylaxis for both mother and child e. the mother should be advised that picaridin is the insect repellent of choice for her in view of her pregnancy a -year-old student planned to travel to cambodia the following month to volunteer in a rural school, where he would be staying with a local family. following weeks of work, he planned to travel around south-east asia for a further month. he had travelled to south america the previous year but had experienced repeated 'stomach problems' while abroad and was worried about having the same issues again. what advice should he be given with regard to prevention of gastrointestinal problems while abroad? a. given the problems he had last time, antibiotics should be taken as a preventive measure b. ciprofloxacin should be given as a 'standby treatment' if he develops moderate or severe symptoms c. hand, food and water hygiene advice should be an essential part of the consultation d. if he develops bloody diarrhoea with fever, he should start antibiotics e. antimotility agents are not generally recommended health risks among travellers e need for regular updates pre-travel health adviceseeking behavior among us international travelers departing from boston logan international airport travel clinic consultation and risk assessment guidelines for the prevention and treatment of travelers' diarrhea: a graded expert panel report e . further reading lalloo dg, hill dr. preventing malaria in travellers adverse event reports following yellow fever vaccination safe travels? hiv transmission among britons travelling abroad enteropathogens and chronic illness in returning travelers epidemiology of travel-related hospitalization key: cord- -yjn sja authors: o'connor, daryl b.; aggleton, john p.; chakrabarti, bhismadev; cooper, cary l.; creswell, cathy; dunsmuir, sandra; fiske, susan t.; gathercole, susan; gough, brendan; ireland, jane l.; jones, marc v.; jowett, adam; kagan, carolyn; karanika‐murray, maria; kaye, linda k.; kumari, veena; lewandowsky, stephan; lightman, stafford; malpass, debra; meins, elizabeth; morgan, b. paul; morrison coulthard, lisa j.; reicher, stephen d.; schacter, daniel l.; sherman, susan m.; simms, victoria; williams, antony; wykes, til; armitage, christopher j. title: research priorities for the covid‐ pandemic and beyond: a call to action for psychological science date: - - journal: br j psychol doi: . /bjop. sha: doc_id: cord_uid: yjn sja the severe acute respiratory syndrome coronavirus‐ (sars‐cov‐ ) that has caused the coronavirus disease (covid‐ ) pandemic represents the greatest international biopsychosocial emergency the world has faced for a century, and psychological science has an integral role to offer in helping societies recover. the aim of this paper is to set out the shorter‐ and longer‐term priorities for research in psychological science that will (a) frame the breadth and scope of potential contributions from across the discipline; (b) enable researchers to focus their resources on gaps in knowledge; and (c) help funders and policymakers make informed decisions about future research priorities in order to best meet the needs of societies as they emerge from the acute phase of the pandemic. the research priorities were informed by an expert panel convened by the british psychological society that reflects the breadth of the discipline; a wider advisory panel with international input; and a survey of psychological scientists conducted early in may . the most pressing need is to research the negative biopsychosocial impacts of the covid‐ pandemic to facilitate immediate and longer‐term recovery, not only in relation to mental health, but also in relation to behaviour change and adherence, work, education, children and families, physical health and the brain, and social cohesion and connectedness. we call on psychological scientists to work collaboratively with other scientists and stakeholders, establish consortia, and develop innovative research methods while maintaining high‐quality, open, and rigorous research standards. the global impact of the coronavirus disease (covid- ) is unprecedented. by the june , in excess of million cases of covid- worldwide had been confirmed and covid- -related deaths were close to half a million. however, its impact should not only be measured in terms of biological outcomes, but also in terms of its economic, health, psychological, and social consequences. the covid- pandemic is unique with respect to the ongoing risks associated with the large numbers of infected people who remain asymptomatic, the impacts of the countermeasures on societies, the likelihood of second or third waves, and the attention it has received due to its global reach (particularly in high-income countries). the effects of the covid- pandemic will likely shape human behaviour in perpetuity. psychological science is uniquely placed to help mitigate the many shorter-and longer-term consequences of the pandemic and to help with recovery and adjustment to daily life. the immediate research response to covid- was rightly to focus resources on the transmission of covid- , identify biologics with which to treat those infected with the virus, and develop vaccines to protect populations. however, biomedical science can only go so far in mitigating the severe negative health, economic, psychological, and social impacts of covid- . the future availability of a vaccine currently remains uncertain; therefore, the primary weapons to mitigate the pandemic are behavioural, such as encouraging people to observe government instructions, self-isolation, quarantining, and physical distancing. even if a vaccine becomes available, we will still require changes in behaviour to ensure its effective delivery and universal uptake, so we need to prioritize research that will make the greatest contributions to our understanding of the effects of, and recovery from, the pandemic. the important contributions made by psychological scientists to understanding the impact of previous pandemics, including the ebola disease outbreak, severe acute respiratory syndrome (sars), and the middle east respiratory syndrome (mers), are welldocumented and mean we knew already a lot about public messaging and stress among frontline workers when the covid- outbreak began (e.g., brooks et al., , holmes et al., rubin, potts, & michie, ; tam, pang, lam, & chiu, ; thompson, garfin, holman, & silver, ; wu et al., ) . however, the unique features of covid- , including its virulence, the large proportions of people who remain asymptomatic but may still spread the virus (centre for evidence-based medicine, ), the stringent lockdown procedures imposed at pace on whole societies, and its global reach mean there is an urgent and ongoing need for social science research (world health organisation, ) . the collective and individual responses to severe acute respiratory syndrome coronavirus- (sars-cov- ) and to the introduction of measures to counter it have fundamentally changed how societies function, affecting how we work, educate, parent, socialize, shop, communicate, and travel. it has led to bereavements at scale, as well as frontline workers being exposed to alarming levels of stress (e.g., british medical association, ; greenberg, docherty, gnanapragasam, & wessely, ) . there have additionally been nationwide 'lockdowns' comprising physical distancing, quarantines, and isolation with the associated effects on loneliness, forced remote working, and homeschooling (e.g., hoffart, johnson, & ebrahimi, ; holmes et al., ; lee, ) . however, as well as having adverse psychological effects, the measures introduced to fight the pandemic may have led to positive social and behavioural changes. most obvious are the remarkable levels of compassion and support that have developed among neighbours and within communities as well as positive changes in behaviours such as hand hygiene, homeschooling, and physical activity. therefore, in addition to mitigating the negative effects of the pandemic, it is important to understand how any positive effects can be maintained as restrictions ease. there are, and will undoubtedly continue to be, inequalities in the effects of the pandemic and its aftermath; recognizing these vulnerability and resilience factors will be key to understanding how the current situation can inform and prepare us for dealing with future crises. of course, while we, as psychological scientists, are interested in the general effects of the pandemic, we are acutely aware of the fact that these effects disproportionately impact on different groups (box ). the issue of inequality is of central importance and runs through the research priorities that we describe below and it is a picture is emerging of covid- not as a single pandemic, but multiple parallel pandemics with some people facing numerous severe challenges and others experiencing few or none (williamson et al., ) . for those most vulnerable groups, the social, economic, and consequent psychological challenges of the pandemic are likely to be far-reaching and sustained. a clear priority for psychological scientists is to understand how best to help those in need and to consider the following factors in their research efforts. in western europe and the united states, the death rate among people with black, asian, and minority ethnic backgrounds is substantially higher than that of the general population. it is not known what is causing the disproportionate impact nor how it can be mitigated. psychological science is in a good position to explore the biopsychosocial antecedents and consequences of having a black, asian, or minority ethnic background in the context of covid- . individuals living in poverty face disproportionate challenges in relation to education, work, income, housing, and physical and mental health. for these most vulnerable groups, the social, economic, and consequent psychological challenges of the pandemic are likely to be far-reaching and sustained. moreover, an impending financial crisis means that people who have never before experienced hardships may suddenly find themselves in precarious circumstances. a quarter of people in the uk experience mental health problems every year, with particularly high levels in young people (mental health foundation, ) . the changed social conditions of the pandemic may increase the severity of mental health challenges, particularly when standard (face-toface) treatment and support are difficult to access. at the same time, pregnant women and those with existing long-term conditions such as transplant patients, cancer patients, and chronic obstructive pulmonary disease patients have been designated 'extremely vulnerable' and asked to self-isolate for long periods of time with uncertainties over access to support. those individuals who have recovered from covid- might also have new biological vulnerabilities, uncertainty over immunity post-covid- , and risk stigma arising from infection. individuals with disabilities, learning disabilities, special educational needs, and developmental disorders may also be more vulnerable due to the increased psychological challenges associated with shielding and self-isolation. the challenges generated by the pandemic vary markedly across the lifespan and will influence the nature of current and future psychological needs of different groups. many young people have struggled with reductions in direct social contact, decreased motivation, and uncertainty caused by disrupted training and education. adults have experienced multiple stresses as a consequence of intensified caring responsibilities, financial concerns, job uncertainty, and health conditions. for many older people, the greatest challenges have been social isolation, disruptions in access to health and social care, and coping with bereavement. in addition to the challenges surrounding age, there are emerging data to suggest that the effects of covid- may exacerbate existing inequalities for women. for example, women are more likely to be key workers and primary caregivers, thereby being exposed to higher levels of psychological and financial stress (fawcett society, ). the covid- pandemic is likely to have had a disproportionate impact on groups with low levels of social inclusion and/or those who traditionally have declined support services, such as people living in poverty, traveller communities, and people who are homeless. being separated from wider support networks may also be particularly difficult for those living in hostile households such as victims of domestic abuse and lgbt people living with family members who are unaccepting of their identity. many of those detained in secure settings have been exposed to marked changes in service delivery and reduced social contact, increasing their vulnerability to the psychological effects of the pandemic. surely not a coincidence that the murder of george floyd during a global pandemic prompted a global civil rights movement drawing attention to inequalities. in this position paper, informed by a group of experts and a survey (box ), we highlight the many ways in which psychological science, its methods, approaches, and interventions can be harnessed to help governments, policymakers, national health services, education sectors, and economies recover from covid- (box ) and other future pandemics (if they occur). specifically, we have identified the shorter-and longerterm priorities around mental health, behaviour change and adherence, work, education, children and families, physical health and the brain, and social cohesion and connectedness in order to ( ) frame the breadth and scope of potential contributions from across the discipline, ( ) assist psychological scientists in focusing their resources on gaps in the literature, and ( ) help funders and policymakers make informed decisions about the shorter-and longer-term covid- research priorities to meet the needs of societies as they emerge from the acute phase of the crisis. the methodology we employed to develop the main research priority domains is described in box , and the seven priority domains are outlined below and summarized in table . how does collective identification impact on social responsibility and adherence to anti-pandemic measures? one of the most striking aspects of the covid- pandemic has been the importance of social psychology to the outcomes. given the highly differentiated nature of susceptibility to the virus (box ), one might have expected many (especially the young and fit) to conclude that they have more to lose than gain by observing the rigours of lockdown and other preventative measures. if they had acted on such an individualistic calculus, then far more people would get infected and far more (especially the old and infirm) would die. however, on the whole, people did not act on the basis of such narrow self-interest, and the vast majority supported the lockdown (e.g., duffy & allington, ) . what is more, conversely, well-functioning social support is likely to confer resilience against the negative psychological impacts of the pandemic. finally, it is important that psychological scientists consider the interconnectedness of the above factors. for example, individuals who are young and from a bame background who are also from a less affluent socio-economic background may be disproportionately impacted by the educational, economic, and other consequences of the measures taken to contain and recover from the pandemic. similarly, many of the solutions to the problems posed by the pandemic involve the use of new technologies that assume the requisite skills, access to devices, and internet connectivity meaning that the 'digital divide' will likely have been exacerbated by the pandemic (ons, ). this paper outlines research priorities for psychological science for the covid- pandemic. in april , the british psychological society convened a core group of nine experts who met regularly for weeks in order to develop the research priorities. the nine experts represent broad areas of the discipline, namely biological, clinical, cognitive, developmental, educational, health, occupational, and social, and were assisted by a wider advisory group of psychological scientists (n = ) drawn from a range of uk higher education institutions and areas of research expertise. we also received input from two international experts. briefly, we used an iterative expert consensus procedure (e.g., merry, cooper, soyannwo, wilson, & eichhorn, ) to elicit and distil the judgments of experts on the research priorities for psychological science. unlike other consensus methods, which typically start with a list of priorities that are then ranked over the course of or meetings (e.g., fitch, bernstein, aguilar, burnand, & lacalle, ; mcmillan, king, & tully, ) , the present approach both generated and judged the priorities over hour long face-to-face meetings of the core group. consensus was achieved through discussion, and the experts were encouraged to discuss with the wider advisory group and their professional networks in between meetings. given the need to establish the priorities rapidly, a lengthy consultation process or an extensive review of all relevant scientific literatures was not possible. however, a brief online survey of psychological scientists was launched early in may with the aim of ensuring that the core and advisory groups had not missed any key research priorities, and to identify the highest ranked priorities in each of the broad areas of psychology to help inform the final wider-ranging research priority domains. the online survey had two components: first, participants were asked the open-ended question, 'please can you tell us what are your priorities for psychological science research in response to the covid- pandemic?' second, participants were asked to rank order the top five research priorities identified by the core group in each of the eight broad areas of the discipline (i.e., biological, clinical, cognitive, developmental, educational, health, occupational, social). the survey was distributed to psychologists via heads of uk psychology department email lists, the social media outlets of professional psychology networks (including the british psychological society), and snowball email methods by the expert and advisory group members. we received replies from psychological scientists representing all of the main areas of the discipline. respondents were . % female, . % were aged between and years, and . % self-identified as being from a minority group. the highest ranked research priorities in each of the broad areas are presented in table (see appendix for the full list of priorities). as a result of the time constraints, a detailed qualitative analysis was not possible for inclusion in this paper; nevertheless, the core group gave consideration to all of the free responses provided. overall, there were differing degrees of specificity, and respondents provided numerous, additional, and wellspecified research questions. however, at the broadest level, respondents' priorities coalesced around the question of how do we address the negative biopsychosocial effects of the covid- pandemic? the degrees of specificity related to population (e.g., people with black, asian, and minority ethnic backgrounds, children, people with low socio-economic status, people living with long-term conditions), type of intervention (e.g., service provision, environmental/social planning), methodology (e.g., qualitative, online, survey, laboratory-based), and setting (e.g., workplace, school, prison), but there was broad agreement. perceived personal risk bears no relation to whether people adhere to government instructions: whether or not one identifies with the broader community and hence acts on the basis of the risks to the community as a whole is the key driver (jackson et al., ) . so, getting people to think in collective rather than personal terms is critical to controlling the pandemic (reicher & drury, ) . or, in the rather more forceful terms of new york governor andrew cuomo: 'yeah it's your life do whatever you want, but you are now responsible for my life. you have a responsibility to me. it's not just about you . . . we started saying, "it's not about me it's about we." get your head around the we concept. it's not all about you. it's about me too. it's about we'. how can we nurture the development and persistence of mutual aid and pro-social behaviour? the significance of such 'we-thinking' is not limited to issues of adherence and social responsibility. the literature on behaviour in disasters and emergencies (drury, ) suggests that the experience of common fate in such events leads to a sense of shared social identity that in turn underpins solidarity and cohesiveness between peopleeven strangers. we have seen numerous examples of 'we-thinking' in the time of pandemic, which have played a key role in sustaining people through difficult circumstances. these range from neighbours knocking on doors to see whether people need help to over three million people contributing to more than four thousand mutual aid groups across the uk (butler, ) . so, how can we nurture such we-thinking in order to build mutual aid in communities and ensure it endures even after the acute phase of the covid- pandemic is over? what is the relationship between group membership, connectedness, and well-being? there is growing evidence of the role of group membership in sustaining both physical and mental health (haslam, jetten, cruwys, dingle, & haslam, ) . in addition to asking in general terms about how group identities are created, sustained, or else undermined in times of crises, we also need to investigate further the interface between group processes and health during and after periods of crisis. in other words: how can we keep people psychologically together even when they are physically apart and what is the relationship between face-to-face and virtual groups in terms of their health effects? more generally, that is not to say that all research priorities were covered in the original survey. two issues in particular stood out from the comments we received. the first was the importance of dealing with inequalities and differences between groups in the experience of the pandemic. the second was the need to address the positive as well as the negative developments coming out of the response to covid- . these were both incorporated into revisions of the paper and now occupy a much more central place than before. we are thankful to all those anonymous respondents whose comments helped improve our argument. a more rigorous, thematic analysis of these data is now available (see bps, c). the picture was very similar when respondents were asked to place research priorities identified by the expert group into rank orders. that is, broadly speaking, the priorities that received the highest rankings, irrespective of area of subdiscipline, were related to the need to address the negative biopsychosocial effects of the covid- pandemic. box : psychological science: methods, approaches, and interventions to help meet the immediate and longer-term covid- research priorities the future research landscape will be challenging due to the ongoing physical distancing requirements; however, psychological scientists are equipped with a broad range of methods, approaches, and interventions that will allow these research priorities to be met. some examples are as follows: internet-mediated research will be an important approach utilized by psychological scientists to collect data in the immediate post-pandemic phase and at longer-term follow-ups. internet-mediated research can be reactive (e.g., online surveys, online interviews) and non-reactive (e.g., data mining, observations from screen-time apps) and can be integrated with objective assessments of behaviour as well as with biological and social markers of physical and mental health. internet-mediated research can also be used to run experiments with online software available such as gorilla, psychopy, and e-prime. recent work has summarized the range of software for building behavioural tasks, and their efficacy in being used online (sauter, draschkow, & mack, ) . changes in the use of research methodologies may provide a catalyst for the formation of new collaborations and training to develop research skills in the psychological science community. at the same time, trust around data security and confidentiality will need to be built between researchers and the general public from whom we sample. however, in , more than an estimated million people aged - years in the european union reported they had not used the internet in the preceding months (eurostat, ) , and researchers will need to think creatively about conducting research projects remotely. for example, participants can have study materials delivered by post (e.g., salivettes for cortisol sampling or asking participants to self-sample), replacing face-to-face communication with telephone and/or video calls, and the use of personal protective equipment when collecting data. psychological therapies and behaviour change interventions can already be delivered remotely and evidence suggests that remote delivery does not necessarily mean inferior delivery (e.g., irvine et al., ) . urgent research is needed to translate interventions that are typically delivered in-person to telephone and online delivery modalities. psychologists are well-positioned to collect valuable qualitative data concerning people's relevant experiences, perspectives, and practices associated with covid- , which could inform psychologybased interventions to improve well-being and social cohesion. multiple participant-centred qualitative research methods can be rapidly deployed to elicit first-hand accounts from members of different communities, including (online) interviews, focus groups, and qualitative questionnaires, focusing on the psychological and social impact (jowett, ) . beyond the immediate term, qualitative data can be gathered longitudinally so that insights can be generated into the experiences of diverse groups over time, identifying salient crisis points and effective resolutions. implementation science is a branch of psychological science that is dedicated to the uptake and use of research into clinical, educational, health care, organizational, and policy settings. principles of implementation science can be used to help stakeholders navigate the extensive and unwieldy psychological science research literature. to inform policymakers and support professional decisionmaking about implementation, psychological research needs to be disseminated in an accessible format. one example of a well-regarded translational system is the us institute of education sciences what works clearinghouse (https://ies.ed.gov/ncee/wwc/), which provides reviews and recommendations about evidence-based practices for professionals working in educational settings. can we learn from this in order to improve the plight of socially isolated people as we emerge from the acute phase of the pandemic? under what conditions does unity and social solidarity give way to intergroup division and social conflict? finally, in addressing the positive potential of social psychological processes, we must not forget their darker side. 'we' thinking can all too easily slip into 'we and they' thinking, where particular groups are excluded from the community and then blamedeven an important feature of the covid- pandemic has been requested by government to provide psychological science expertise at pace. the inclination of many psychological scientists is to begin designing a new study or conducting a systematic review following preferred reporting items for systematic reviews and meta-analyses (prisma) guidelines, but this does not meet the needs of policymakers. it would be valuable for psychological scientists providing expert advice to acquaint themselves with the terminology and procedures that are familiar to civil servants who are more likely to have use for a quick scoping review or rapid evidence assessment (collins, coughlin, miller, & kirk, ) rather than embarking on a time-consuming systematic review of systematic reviews (keyworth, epton, goldthorpe, calam, & armitage, ) . there are many challenges involved with conducting covid- -related research including dealing with vulnerable groups, giving due consideration to ethical concerns, as well as issues around running studies in the light of physical distancing requirements. therefore, having relevant patient and public involvement and including individuals with lived experience (as appropriate) in designing studies will be of paramount importance. psychological science has been leading the way in promoting and adopting open science principles and practices. nevertheless, psychological scientists need to ensure they balance the urgency of conducting covid-related research (during and in the recovery period) with ensuring research quality and open research practices. therefore, in order to help maintain quality, openness, and rigour, we urge researchers to endeavour to use registered reports, where possible (e.g., https://osf.io/rr/), or preregister their research hypotheses and analysis plans (e.g., https://aspredicted.org/) and make their data findable, accessible, interoperable, reusable (fair) recognizing the principle of 'as open as possible; as closed as necessary' (bps, a (bps, , b norris & o'connor, ) . moreover, we urge researchers to utilize pre-print servers, such as psyarxiv, in order to ensure their latest research findings are made publicly available rapidly and at no cost. we hope that openness will drive quality, but as yet there is no substitute for articles being peer-reviewed prior to wider acceptance by the scientific community. psychological science has responded swiftly to the covid- pandemic, but there is a danger of duplication of efforts and participant fatigue in the proliferation of online surveys, experiments, and focus groups that have arisen. we need to harness the ongoing efforts of psychological scientists worldwide in a coordinated effort on the scale of the large hadron collider (cern, ) to deliver truly evidence-based interventions to help societies emerge from the covid- pandemic. this will include cross-cultural research to understand why mortality rates, mitigation measures, and adherence to government instructions have differed so markedly between countries. finally, we urge researchers to register their research studies and findings on international repositories (https://osf. io/collections/coronavirus/discover). attackedfor the crisis. thus, un head antonio guterres has warned of a 'tsunami of hate' unleashed by the pandemic (davidson, ) . this hate and violence can take different forms: of anti-authority riots as in france (willsher & harrap, ) , or of racist violence against minorities as in india (mazumdaru, ) . in sum, insights from social psychology can be a valuable resource in a crisis; it can bring people together and generate constructive social power. but equally, it can set people apart and create problems that endure well beyond the crisis itself. it is evidently of the greatest importance to understand the processes that determine whether people unite or divide in hard timesand notably to understand the role of leadership, which has been so significant and so diverse in different countries during covid- . work environment and working arrangements consistent with previous pandemics (e.g., rubin et al., ) , the work-related challenges of the pandemic have been particularly high and widely recognized for health and social what is the impact of remote and flexible working arrangements on employee health, mental wellbeing, teamwork, performance, organizational productivity, and colleague/client relationships? what is the impact of social distancing in the workplace on employee health, mental well-being, teamwork, performance, organizational productivity, and colleague/client relationships? how can organizational resilience be developed to deal with the impact of covid- whilst supporting employees and protecting jobs? how will the covid- pandemic affect children's development? how will the covid- pandemic affect family functioning? how do school closures influence children's educational progress and well-being? what kinds of support improve long-term outcomes for children and young people? how can support services be effectively delivered to vulnerable children and young people, families, and schools? what are the immediate and longer-term consequences of covid- for mental health outcomes? what changes in approaches resulting from the pandemic need to be harnessed for the future? . physical health and the brain does covid- have neurological effects on the brain with consequences for mental health? what are the psychobiological impacts of the covid- pandemic on physical and mental health? how do we best apply existing theories and tools to promote sustained behaviour change among policymakers, key workers, and the public/patients? how do we develop new theories and tools to promote sustained behaviour change? care workers in direct contact with patients suffering the effects of covid- , leaving them vulnerable to trauma, fatigue, and other manifestations of chronic stress. what is unique about covid- is that changed working conditions and anxiety about infection have affected almost all employees, with particular challenges being faced by delivery workers, shop assistants, teachers, emergency services personnel, care home staff, transport staff, and social workers. the full economic severity of the covid-related restrictions is uncertain, although up to two million people could lose their employment in the uk alone (wilson, cockett, papoutsaki, & takala, ) . for those people still working, and those about to return to work, there are notable changes that will likely affect working practices in the foreseeable future. therefore, understanding the impact of the covid- pandemic on the work environment and new working arrangements is paramount to kick starting the economy and adjusting to daily life. what is the impact of remote and flexible working arrangements on employee health, mental wellbeing, teamwork, performance, organizational productivity, and colleague/client relationships? for many workers, particularly those in white-collar occupations, work took place entirely from home during the lockdown. it is possible that the lockdown will accelerate the general increase observed in home working practices (ons, ). a move to greater levels of remote working has clear economic benefits for employers (e.g., reduced estates costs). the flexibility to balance work and family life is also attractive to many employees (cf. strategic review of health inequalities in england, ). overall, the evidence points to positive benefits of remote working in terms of well-being (charalampous, grant, tramontano, & michailidis, ) , although these effects are not consistent. for example, it may lead to greater levels of professional isolation (golden, veiga, & dino, ). an increase in remote working will likely occur with a concomitant increase in the use of online technology to support communication and aspects of collaborative working. this has the potential to blur boundaries between work and home domains, resulting in negative impacts on well-being and productivity from work-home interference (van hoof, geurts, kompier, & taris, ) . greater use of technology may also be associated with different perceptual and cognitive demands that may affect productivity and wellbeing including social connections with work colleagues (e.g., mark et al., ) . what is the impact of physical distancing in the workplace on employee health, mental well-being, teamwork, performance, organizational productivity, and colleague/client relationships? until an effective vaccine is available, physical distancing rules will need to continue to be in place in work environments and we may experience multiple stay-at-home versus return-towork cycles. there is very little research exploring physical distancing and its effect on the general workplace, but returning to work will likely be both a welcome change and a potential stressor. while we have research from teams working in difficult and extreme environments (power, ; smith, kinnafick, & saunders, ) and research on professional isolation (golden et al., ) , this is an unprecedented opportunity to study adaptation across a breadth of individuals and organizational settings. how can organizational resilience be developed to deal with the impact of covid- whilst supporting employees and protecting jobs? the unprecedented demands that the pandemic has placed on organizations also offer a unique opportunity to understand how organizational resilience and preparedness for dealing with disruptions and emergencies can be developed. while a pandemic of this nature is rare, we can anticipate increasing periods of disruption due to covid- flareups and additionally, for example, in response to climate-induced events (e.g., recent australian fires, uk flooding), which are predicted to occur more frequently (banholzer, kossin, & donner, ) . although we know a lot about individual resilience, we know relatively little about organizational resilience, especially in the context of well-being and performance (taylor, dollard, clark, dormann, & bakker, ; fasey, sarkar, wagstaff & johnston, under review) and the ingredients such as the structures, processes, culture, and leadership that are essential for developing organizational resilience. parenting can be a challenging and anxiety-provoking experience at any time, but the covid- pandemic has brought these challenges and anxieties into sharp focus. for most families, the lockdown will represent the longest period of parenting they have experienced without ( ) the support of extended family members, friends, and childcare professionals; ( ) the routine of school and out-of-school activities; and ( ) any face-to-face social life outside the home. these changes in the social environment may have both negative and positive impacts on children and their families. at the most extreme end of the spectrum, the restrictions in place to combat the spread of the virus have been associated with worrying increases in domestic violence and child abuse. however, all families are likely to have experienced greater levels of stress (social care institute for excellence, ). the majority of carers with school-age children are dealing with homeschooling for the first time, and many carers are having to adapt to working from home while also looking after their children and older relatives. these pressures will be particularly acute for single-carer families. of course, such multi-tasking concerns apply only to carers fortunate enough to have maintained employment. it is important to support families during the current crisis, but also to understand the implications of these unprecedented changes in family life for family functioning and children's development as we emerge from the pandemic. how will the covid- pandemic affect family functioning? many effects of the pandemic on children's development are likely to be indirect, functioning through its impact on caregiving and family functioning. it is crucial for this research to include family members such as grandparents and non-resident parents and siblings. children in families who are already vulnerable due to domestic violence or abuse, social or economic disadvantage, or physical or mental ill health are likely to be most adversely affected. there is an urgent need for research to examine how these vulnerabilities moderate changes in family functioning post-pandemic and their impacts on the child. the ability to regulate behaviour and emotional responses is a key aspect of successful social interaction in individuals of all ages (e.g., baumeister & heatherton, ; kochanska, murray, & harlan, ) . family members may develop new self-regulation strategies as a result of having extended contact with the same restricted group of people. while such strategies may be adaptive, individuals facing extreme social or financial challenges may cope by psychologically distancing themselves from family members, ruminating on negative events, or engaging in behaviours that are harmful. understanding how adaptive and maladaptive self-regulation strategies change post-pandemic may prove useful in identifying individuals who need additional psychological support. school closures and social restrictions may provide a unique opportunity for family members to gain insight into each other's lives, potentially reducing disagreements and improving family functioning. research should investigate whether reporting such improvement during the crisis is associated with lower caregiving stress and better mental health. it is also important to study how families can maintain any positive aspects of functioning that have resulted from the pandemic as restrictions are eased. how will the covid- pandemic affect children's development? the effects of the pandemic will undoubtedly vary as a function of the child's age. while carers with young infants may have concerns about the negative impact of the lockdown on their babies' development, the infants themselves will be unaware of the abnormal nature of their social environment. optimal later development is predicted by caregivers' ability in the first year of life to see the world from the infant's point of view and respond appropriately to their cues (e.g., fraley, roisman, & haltigan, ; zeegers, colonnesi, stams, & meins, ) . the social restrictions do not obviously impede this type of infantcaregiver engagement, and young infants may therefore be least affected by the pandemic. older children who recognize the drastic changes in social contact may find transitioning back to pre-pandemic social behaviour difficult. it is therefore important to study how children and young people manage this transition and investigate whether the lockdown has raised the incidence of emotional and behavioural difficulties. studying the effects of the pandemic and its aftermath on particular groups that are known to be vulnerable to educational and health disadvantage (e.g., looked after children or children with developmental disorders) should be prioritized. positive effects of the pandemic on children's behaviour and social interaction are also anticipated. many children and young people will have found new ways to communicate with friends, entertain themselves, and keep themselves physically active. time away from school may have been spent learning new skills, developing new hobbies, or helping or supporting others. investigating changes in children and young people's empathy, altruism, theory of mind, creativity, innovation, problem-solving, and cognitive flexibility post-pandemic will help shed light on potential positive outcomes of the social restrictions associated with the pandemic. the challenges posed by the covid- pandemic have never been more evident than for the education and well-being of children and young people. in april , a third of the world's population were experiencing extended periods of lockdown with closure of schools and nurseries. parents, many of whom had work and other family responsibilities had to adopt the additional role of educator in home environments not set up for formalized learning. ad hoc arrangements were put in place at speed by schools with limited opportunities to develop clear definitions of learning activities, provide access to learning resources, and establish effective home-school communication. early surveys have shown wide variation in homeschooling arrangements, including stark differences between state and private schools in access to online learning and pupil-teacher communication (sutton trust, ) . there is a wealth of evidence about the factors that facilitate effective learning in schools, such as curricula and teaching strategies (hattie, ) . other studies have established that children's academic attainment and adjustment are predicted by higher caregiver education (erola, janolen, & lehti, ) and engagement in schooling (harris & goodall, ) . however, little is known on how to set up and deliver home education effectively under the unique conditions of the pandemic. while for some children the extended period at home is likely to have distinct positive benefits, research prior to covid- on substantial externally driven disruptions in schooling has shown adverse effects on child achievement and well-being (meyers & thomasson, ; sunderman & payne, ). the outcomes for the individual child are likely to depend on the capacity of families to step in and effectively support curriculum delivery at home. studies of other severe unplanned disruptions to schooling and family lives such as long-running strikes and natural disasters have shown greatest impacts on long-term educational and emotional outcomes for the most disadvantaged children (jaume & will en, ; masten & osofsky, ) . at particular risk of disproportionate adverse outcomes are children from families living in poverty, those receiving social care support, individuals with special educational needs and disabilities, and young people with mental health problems. there are high levels of concern that the recognized attainment gap for children from disadvantaged families (education in england: annual report . education policy institute) could be magnified by the pandemic conditions. there is an urgent need to identify and understand both the positive and negative factors that influence children's educational outcomes during and after the pandemic, and to use this knowledge to target support to those who need it most. the unanticipated consequences of the pandemic pose challenges for conventional designs depending on pre-intervention assessments. understanding its impacts on children's lives will require a robust body of research that draws on the diverse research methods of psychological science. this will require large-scale multidisciplinary data collection in addition to smaller-scale quantitative and qualitative approaches that will be vital for understanding the experiences of children, families, and professionals. some key questions to be addressed by this research are outlined below. in addition to collecting data on home-based support for learning, detailed contextual data are needed about social and environmental factors that are likely to interact in determining positive educational outcomes at particular educational phases (e.g., reading, writing, and maths in primary schools), as well as a range of mental health outcomes (e.g., anxiety, depression, self-harm, resilience). this will include research into the effect of social distancing on a range of social outcomes in children and young people (e.g., inclusion/ exclusion, friendships). what kinds of support improve long-term outcomes for children and young people? knowledge about the impacts of school disruptions on all children and young people will allow evidence-based interventions and resources to be targeted at those with greatest need. robust evaluations are required to scrutinize how interventions are accessed, by whom and with what degree of success. how can support services be effectively delivered to vulnerable children and young people, families, and schools? with reduced resources and restricted movement, professionals (such as practitioner psychologists) have had to adapt and develop new ways of delivering services. researchers in psychological science have a key role to play in working with practitioners and service providers to evaluate systems put in place for monitoring and delivering professional support during and in the aftermath of the pandemic. what are the immediate and longer-term consequences of covid- for mental health outcomes? there is expected to be an increase in mental health problems as a result of the covid- pandemic and the measures used to counter it. we already have evidence for the long-term mental health effects of previous pandemics and disasters (e.g., tam et al., ; thompson et al., ; wu et al., ) and an emerging literature on the near-term effects of covid- (e.g., ahmad & rathore, ; williamson et al., ) . but previous pandemics have been more localized and circumscribed making covid- different. social distancing, school closures, self-isolation, and quarantine have lasted longer than anything previously experienced. we know that these factors, together with financial uncertainty and concerns about health, are predictive of mental health difficulties, particularly anxiety. the current pandemic amplifies these factors and not only exacerbates problems in those with pre-existing mental health difficulties, but also increases the chance of new onset in those with no previous contact with mental health services. concerns about mental health effects may be particularly heightened for children, who have experienced high levels of disruption to normative developmental opportunities (including opportunities for social and outdoor play) and education, and potentially high levels of family stress (https://emergingminds.org.uk/cospace-study- ndupdate/). various poor mental health outcomes are also potentially associated with the disease itself. information about the long-term consequences comes from similar viruses such as sars and the mers. for example, many people who suffered from sars seemed to experience detrimental psychological effects even a year later (rogers et al., ; tam et al., ; thompson et al., ; wu et al., ) . therefore, we need to establish the immediate and long-term consequences of covid- on mental health outcomes in the population generally, but also in vulnerable, shielding, and self-isolating groups (box ). we urgently need to understand how all these factors interact and whether these consequences will require psychological interventions and supports not currently available. what changes in approaches resulting from the pandemic need to be harnessed for the future? even if the mental health consequences of this pandemic are not as predicted, we still expect increases in mental health problems. we know that mental health accounts for an increasing proportion of sick leave and that one in eight children and young people experience a diagnosable mental health problem (nhs digital, ) . childhood mental health problems often recur in adulthood (kessler et al., ) and are associated with physical health difficulties, poor academic, and occupational functioning, and are the primary predictor of low adult life satisfaction (layard, clark, cornaglia, powdthavee, & vernoit, ) . the increased prevalence will place a further burden on a mental health system that was already stretched and will increase waiting times and accentuate gaps in care. during the pandemic, mental health services rapidly changed. inpatients were discharged, even if they were detained in hospital because they were a risk to themselves or others. some people benefited, but we do not know how this reduction in bed use was managed. was it because the right supports and accommodation were provided? the move to remote contact in mental health services had been slow and of varied quality prior to covid- with challenges for both staff and service users. but the shift during the pandemic was swift, and although undoubtedly nhs staff felt pressure during the changeover, there now seems to be a steadier state. again, some service users may have benefited from this change with reductions in travel and, for some, better access to care and treatment. however, although the digital divide is reducing (robotham, satkunanathan, doughty, & wykes, ) , it remains highest in those who already have high unmet needs, including people in rural areas, those on lower incomes, people with lower levels of formal education, and older people. if remote working is tobe abeneficial part of an evolved mental health service, then we need to understand how to provide that 'webside' manner that will increase adherence and promote a therapeutic alliance. we also urgently need to evaluate the effectiveness of remotely delivered, digital interventions in the immediate and longer term. future interventions will need to be deliverable remotely, depending on local resources. for example, from an international perspective, many low-to-middle-income countries do not have high broadband penetration; hence, optimizing digital delivery that depends strongly on good internet connections will further widen the welfare gap. physical health and the brain the effects of covid- on health outcomes will be far-reaching and complex. for those falling ill, there are the direct consequences of the disease symptoms, such as respiratory failure in severe cases, alongside potentially direct viral effects on the brain. there are also more indirect population-wide effects of covid- pandemic-related stress and anxiety on physical and mental health, not only from the disease itself but also from changes in lifestyle including delayed treatment and screening for other known or suspected conditions. moreover, it is also likely that from an international perspective, in many lowto-middle-income countries, the pandemic will result in greater hunger/starvation, which will have severe impacts upon health. does covid- have neurological effects on the brain with consequences for mental health? at one level, covid- might alter mental health by the direct actions of the specific virus (severe acute respiratory syndrome coronavirus- ; sars-cov- ) on the brain. while neurological dysfunction is often described in covid- , including dizziness, and loss of taste and smell, these conditions are common to other respiratory tract infections and need not reflect a neurological disease per se (needham, chou, coles, & menon, ) . data from cerebrospinal fluid and post-mortem analyses will help resolve issues over the penetrance of sars-cov- . it is, however, known that the target receptor for sars-cov- is the angiotensin-converting enzyme- receptor (ace ). disruption of the blood-brain barrier during illness might enable entry of the virus, potentially aided by the presence of ace receptors in glial cells and brain endothelium. other potential routes of entry include the cribriform plate and olfactory epithelium, as well as via peripheral nerve terminals, permitting entry to the cns through synapse connected routes (ahmad & rathore, ) . at the same time, there is an array of immunological responses, including the cytokine 'storm' in severe cases, alongside non-immunological insults to the central nervous system provoked by covid- . the latter include hypoxia, hypotension, kidney failure, and thrombotic and homeostatic changes involving neuroendocrine function (needham et al., ) . together and separately, they may contribute to brain dysfunction in ways that vary with the severity of the infection, other underlying conditions (needham et al., ) , and the treatment for those other conditions (south, diz, & chappell, ) . largescale studies help confirm differential clinical risk factors for death following infection (williamson et al., ) , prompting genotype analyses, while noting that covid- might also induce epigenetic changes, including ace demethylation (sawalha, zhao, coit, & lu, ) . additional health concerns include post-viral fatigue and whether it might provoke a long-lasting syndrome. research consortia are initiating comparisons between populations that have or have not contracted covid- . challenges for psychological scientists include how to assess impacts on cognition and mental health, both in the short term and long term. a part of this challenge is how to deliver effective, online psychological testing (e.g., for 'shielded' populations), or to help follow-up large population cohorts, while not biasing the sample away from those least likely to use these platforms. an integral part of some investigations will be the inclusion of multiple neuroimaging methods, despite the era of distancing. just one of many questions would be the impact of covid- on mild cognitive impairment and its conversion to dementia. there is a premium on studying pre-existing cohorts (e.g., uk biobank, alspac), where retrospective, baseline data exist. such data are especially precious in the present landscape where everyone is, to some degree, affected by the pandemic. the power of these pre-existing cohorts will, however, be heavily influenced by the proportion of the population who contract covid- . what are the psychobiological impacts of the covid- pandemic on physical and mental health? despite the umbrella term 'stress' covering many different things, there is agreement that in its different forms, stress can lead to physiological changes (e.g., neuroendocrine, cardiovascular), with negative consequences for health (o'connor, thayer & vedhara, in press). three principal research questions can be identified: ( ) to what extent does pandemic-related stress, anxiety, and worry impact on biological mechanisms that influence health (i.e., hypothalamic-pituitary-adrenal axis regulation and cortisol dynamics, the autonomic nervous system, and gene expression) as well as on health behaviours (e.g., eating, sleep, alcohol consumption)? ( ) how best to counter their adverse effects? and ( ) how might such stress exacerbate existing medical and mental health conditions, and for how long? for all three questions, there will be considerable variations between groups and individuals (box ). one challenge will be to collate and verify relevant information, including that from 'smart' devices that can provide daily physiological data, activity information, and other measures of diurnal patterns, including sleep. one of the groups most likely to be negatively affected by stress is health care professionals. the pandemic may exacerbate the already high prevalence of secondary traumatic stress, burnout, and physical exhaustion among health care professionals, as well as impact on patient safety and medical error (e.g., dar & iqbal, ; figley, ; hall, johnson, watt, tsipa, & o'connor, ) , due to excessive workload and workplace trauma (e.g., itzhaki et al., ) . while resources such as support from managers and colleagues can help protect health care professionals against traumatic stress, the longerterm impact is likely to be substantial on individuals, their families, on the national health services and the wider care industry. amongst other groups of concern (box ) are those caring for a vulnerable relative or partner at home. one novel feature of daily life in the wake of the covid- pandemic in countries around the world are near-daily government briefings. one focus of these briefings is government instructions to the public as to how to behave. adherence to these and future instructions will be key to dealing with future crises. moreover, many sections above share in common the requirement that people adhere to instructions, whether it is practitioners delivering psychological therapies effectively over the telephone or employees continuing to maintain physical distancing at work. in the initial response to the pandemic, many governments instructed people to ( ) stay inside as much as possible; ( ) stay > m away from other people at all times; and ( ) maintain hand hygiene, among other measures such as wearing face coverings. the evidence suggests that public adherence to government covid- -related instructions worldwide has been high (ons, ), but it is not clear for how long people will continue to adhere to instructions that impinge on personal freedoms. what is clear is that there is a dearth of workers sufficiently trained to advise policymakers and to implement behaviour change interventions rapidly and at scale. the british psychological society's guidance on behaviour change is a good starting point for ensuring that instructions and messaging is clear (british psychological society, a). appointing chief behavioural science advisers to governments would ensure that cuttingedge psychological science advice is placed at the heart of policymaking. as people begin to emerge from the acute phase of the pandemic and the changes that were made to tackle it, it is important that psychological science is at the heart of ensuring that health-enhancing behaviours are sustained and that health-damaging behaviours are changed or prevented. there are numerous approaches to developing such interventions, including the behaviour change wheel (michie, atkins, & west, ) and intervention mapping (bartholomew eldrigde et al., ) , but they require the expertise of psychological scientists to deliver and to evaluate them (west, michie, rubin, & amlôt, ) . one of the main challenges now, and in the future, will be to ensure there is a workforce equipped with the competencies to develop behaviour change theory and tools that will bring about sustained changes in behaviour. taught post-graduate courses exist that could be scaled up and/or adapted to continuing professional development qualifications to meet this demand and help ensure that the changes in behaviour that will be required for the foreseeable future are sustained. how do we best apply existing theories and tools to promote sustained behaviour change among policymakers, key workers, and the public/patients? we sometimes forget that we have the theories and evidence for solutions that can be applied at pace to address novel problems. although we have never seen a lockdown before and so cannot predict what the outcomes will be directly, we do know what processes underpin adherence to instructions, and so can advise on the levers that can sustain adherence. in unprecedented and uncertain times now and in whatever the future might bring, the nature of psychological science allows us to make unique and invaluable contributions. if the covid- pandemic teaches us one thing, it is on the need to accelerate the translation of evidence from psychological science into practice. how do we develop new theories and tools to promote sustained behaviour change? at the same time, we should not forget the 'slow' approach to research (armitage, ) that involves addressing key research questions with multiple perspectives and methodologies, and accumulating such knowledge in prisma-guided systematic reviews. it is vital that continued investment is made into behaviour change research. only with this can we refine and develop the theories that best explain human behaviour (e.g., michie et al., ) . key research priorities include identifying which behaviour change techniques work best, for whom, in which contexts, and delivered by what means (e.g., epton, currie, & armitage, ) as well as how to counter the conspiracy theories and misinformation that arise during crises that seem to be aimed at derailing the very behaviours required to keep us safe and to reduce risk. in this position paper, we have set out seven research priority domains in which psychological science, its methods, approaches, and interventions can be harnessed in order to help governments, policymakers, national health services, education sectors, economies, individuals, and families recover from covid- . these are mental health, behaviour change and adherence, work, education, children and families, physical health and the brain, and social cohesion and connectedness. we have also highlighted that a clear overarching research priority relates to understanding the inequalities in the effects of the pandemic and recovery; recognizing the vulnerability and resilience factors that will be key to understanding how the current pandemic can inform and prepare us for dealing with future crises. we call on psychological scientists to work collaboratively with other scientists in order to address the research questions outlined, refine them and to adopt multidisciplinary working practices that combine different disciplinary approaches. an important next step will be to engage with wider stakeholders, potential users, individuals with lived experience, and beneficiaries of the research. addressing each of the research priority domains will benefit enormously from larger scale working and coordinated data collection techniques and the establishment of research consortia with their associated economies of scale. we also call on psychological scientists to further develop and adapt innovative research methodologies (e.g., remote testing and intervention delivery, online data collection techniques), while maintaining high-quality, open, and rigorous research and ethical standards in order to help with the recovery as we emerge from the acute phase of the crisis. how can we use biological markers to facilitate people's return to work? how do we link covid- -related biomarkers to existing population cohort databases? how do we address the negative biological impacts of the covid- virus on mental health? what are the impacts of covid- infection, treatment, and recovery on the brain? how do school closures influence educational progress, and physical and mental health outcomes for all children and young people? what 'homeschooling' practices are associated with positive educational and psychological outcomes? what is the effect of social distancing on a range of social outcomes in children and young people? what methods are used to track, monitor, and deliver local authority support services to vulnerable children and young people, families, and schools during lockdown, at transition back to school, and after return to school? how are educational and psychological interventions allocated, structured, delivered, and evaluated for children and young people in need, after schools have reopened? what is the impact of remote and flexible working arrangements on employee health, mental well-being, teamwork, performance, organizational productivity, and colleague/client relationships? what is the impact of social distancing in the workplace on employee health, mental well-being, teamwork, performance, organizational productivity, and colleague/client relationships? what managerial behaviours are most effective to manage remote working, possible mental health issues, job insecurity, and productivity? what is the risk of longer-term mental ill health among frontline staff after the immediate crisis? how can organizational resilience be developed to deal with the impact of covid- whilst supporting employees and protecting jobs? neurological manifestations and complications of covid- : a literature review changing behaviour, slow and fast: commentary on peters, de bruin and crutzen the impact of climate change on natural disasters planning health promotion programs: an intervention mapping approach self-regulation failure: an overview stress and burnout warning over covid- behavioural science and disease prevention taskforce. behavioural science and disease prevention: psychological guidance position statement on open data covid- research priorities for psychological science: a qualitative analysis the psychological impact of quarantine and how to reduce it: rapid review of the evidence covid- mutual aid: how to help vulnerable people near you. the guardian lhc the guide systematically reviewing remote e-workers' well-being at work: a multidimensional approach the production of quick scoping reviews and rapid evidence assessments: a how to guide beyond linear evidence: the curvilinear relationship between secondary traumatic stress and vicarious posttraumatic growth among healthcare professionals global report: virus has unleashed a 'tsunami of hate' across world, says un chief. the guardian the role of social identity processes in mass emergency behaviour: an integrative review the accepting, the suffering and the resisting: the different reactions to life under lockdown. the policy institute, king's college london unique effects of setting goals on behavior change: systematic review and meta-analysis parental education, class and income over early life course and children's achievement what do you use the internet for? defining and characterising organisational resilience in elite sport coronavirus: urgent call for uk government to support women and girls compassion fatigue: coping with secondary traumatic stress disorder in those who treat the traumatized the rand/ucla appropriateness method user's manual the legacy of early experiences in development: formalizing alternative models of how early experiences are carried forward over time the impact of professional isolation on teleworker job performance and turnover intentions: does time spent teleworking, interacting face-to-face, or having access to communication-enhancing technology matter managing mental health challenges faced by healthcare workers during covid- pandemic healthcare staff wellbeing, burnout, and patient safety: a systematic review do parents know they matter? engaging all parents in learning the new psychology of health: unlocking the social cure visible learning, a synthesis of over meta-analyses relating to achievement loneliness and social distancing during the covid- pandemic: risk factors and associations with psychopathology multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science are there interactional differences between telephone and face-to-face psychological therapy? a systematic review of comparative studies mental health nurse's exposure to workplace violence leads to job stress, which leads to reduced professional quality of life the lockdown and social norms: why the uk is complying by consent rather than compulsion the long-run effects of teacher strikes: evidence from argentina carrying out qualitative research under lockdown -practical and ethical considerations. lse impact blog age of onset of mental disorders: a review of recent literature delivering opportunistic behavior change interventions: a systematic review of systematic reviews effortful control in early childhood: continuity and change, antecedents, and implications for social development what predicts a successful life? a life-course model of well-being mental health effects of school closures during covid- email duration, batching and self-interruption: patterns of email use on productivity and stress disasters and their impact on child development: introduction to the special section coronavirus: eu fears a rise in hostile takeovers how to use the nominal group and delphi techniques mental health statistics: children and young people an iterative process of global quality improvement: the international standards for a safe practice of anesthesia paralyzed by panic: measuring the effect of school closures during the polio pandemic on educational attainment (no. w ) the behaviour change wheel: a guide to designing interventions neurological implications of covid- infections mental health of children and young people in england - science as behaviour: using a behaviour change approach to increase uptake of open science stress and health: a review of psychobiological processes exploring the uk's digital divide coronavirus and the social impacts on great britain extreme teams: toward a greater understanding of multiagency teamwork during major emergencies and disasters the two psychologies and coronavirus. the psychologist do we still have a digital divide in mental health? a five-year survey follow-up psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the covid- pandemic the impact of communications about swine flu (influenza a h n v) on public responses to the outbreak: results from national telephone surveys in the uk building, hosting and recruiting: a brief introduction to running behavioral experiments online epigenetic dysregulation of ace and interferonregulated genes might suggest increased covid- susceptibility and severity in lupus patients coping strategies used during an extreme antarctic expedition domestic violence and abuse: safeguarding during the covid- crisis covid- , ace , and the cardiovascular consequences strategic review of health inequalities in england post- does closing schools cause educational harm? a review of the research. information brief covid- impacts: school shutdown severe acute respiratory syndrome (sars) in hong kong in : stress and the psychological impact among frontline healthcare workers psychosocial safety climate as a factor in organisational resilience: implications for worker psychological health, resilience, and engagement distress, worry, and functioning following a global health crisis: a national study of americans' responses to ebola work-home interference: how does it manifest itself from day to day? applying principles of behaviour change to reduce sars-cov- transmission opensafely: factors associated with covid- death in million patients in a paris banlieue, coronavirus amplifies years of inequality. the guardian getting back to work: dealing with the labour market impacts of the covid- recession. institute for employment studies coronavirus disease (covid- ) the psychological impact of the sars epidemic on hospital employees in china: exposure, risk perfection, and altruistic acceptance of risk mind matters: a three-level meta-analysis on parental mentalization and sensitivity as predictors of infant-parent attachment christopher armitage's contribution is supported by the nihr manchester biomedical research centre and the nihr greater manchester patient safety translational research centre. the views expressed in this publication are those of the authors and not necessarily those of nihr. armitage would like to thank professors madelynne arden and alison wearden for their support in writing. til wykes would like to acknowledge the support of her nihr senior investigator award. the set of priorities utilized for the survey of the psychological community.how do we increase adherence (and ability to adhere) to uk government covid- related instructions? how do we promote maintenance of positive behaviour changes and reverse negative behaviour changes resulting from covid- -related lockdown? how do we address the negative psychological impacts of the covid- pandemic? how do we maximize recovery from covid- for those infected with the virus? what is the impact of covid- -related stress on biological processes and health outcomes? what makes people adhere to anti-covid measures? what are the bases of anti-social behaviours such as stockpiling? how do mutual aid groups form and what makes them endure? when does social cohesion give way to scapegoating, prejudice, and intergroup conflict? what creates (or prevents) the potential for protests and collective disorder in the crisis? what are the long-term mental health effects of covid- ? what coping mechanisms are useful in reducing mental health problems during a pandemic? how do we provide beneficial remote psychological therapy and maintain therapeutic alliance? has discussion of mental health during the pandemic reduced stigma and discrimination in the community? people detained in hospital under the mental health act were discharged to free up bedshow was this possible? what are the impacts of covid- infection, treatment, and recovery on cognition, behaviour, and the brain? what are the drivers of covid- -related stress and its cognitive, neural, and physiological mechanisms and consequences? what are the perceptual and cognitive demands of digital and other alternative forms of communication and how do they impact on work and social connectivity? what factors influence the effectiveness of communication of scientific evidence and national guidance, and how do they influence behaviour? how do restrictions of movement, communication, and social support influence the cognitive, physical, and mental health of older individuals, and what factors lead to improved outcomes? how has the covid- pandemic affected parenting? how has the covid- pandemic affected children's development? how has the covid- pandemic affected family functioning? which factors moderate family members' response to the covid- pandemic? what support is most effective for families during the covid- pandemic? how do we assess biological markers of health and well-being remotely?continued key: cord- -axbyav m authors: kimball, ann marie title: emergence of novel human infections: new insights and new challenges date: - - journal: international encyclopedia of public health doi: . /b - - - - . - sha: doc_id: cord_uid: axbyav m novel human infections have continued to emerge over the past decade. their presentation, epidemiology, and microbiology have shifted the paradigms of traditional science. in particular insights into nongenetic or paragenetic mechanisms (plasmid mediated), modes of infection have challenged biology. in reviewing the new challenges posed by these emergent events, new technologies promise some answers; however, global health security against pandemic threats, particularly given the uneven distribution of global resources for prevention, detection, and response, remains a critical area of challenge. new human infections have continued to come forth over the last decade. this discussion will focus on the period from to . given the importance of the severe acute respiratory syndrome (sars) as the harbinger of coronaviruses such as the middle east respiratory syndrome (mers), some discussion of sars is also included. the phenomenon of emerging infections has been constant with the majority of human infections reflecting the introduction into humans of zoonotic pathogens. over the last decade, great progress has been made in defining more fully how emergence occurs. in fact the emergence of new infections has expanded the paradigms of microbiology in a number of ways, which will be highlighted here. specifically: ( ) it is now well appreciated that influenza can migrate directly from avian sources to humans, and the appreciation of the actual directness of 'species jumping' has moved forward; ( ) new infections have also introduced uncertainty in transmission dynamics with emphasis on super-spreader events as well as nosocomial transmission; ( ) infectious particles are not confined to those organisms which contain genetic material; ( ) a new paradigm such as 'planetary health' may be necessary for defining these trends; and ( ) global preparedness and response is not in place for the next pandemic. for further background information, the reader is referred to the original article on this phenomenon (kimball, ) . a general discussion of antimicrobial resistance and xenotransplantation is not included in this discussion as they were thoroughly covered in the original article. antimicrobial resistance will be covered in detail in another article of this volume. nonetheless they continue to be important considerations. while it has long been appreciated that the majority of human pathogens arise from zoonotic sources, the directness of the path from animal to human has become clear. ideally detecting pathogens in animals could be seen as a harbinger for human outbreaks. in fact this has been a working hypothesis of major us agency for international development (usaid) funding to their pandemic agents program. however, recent outbreaks of influenza, sars, and mers coronavirus (cov) demonstrate how emerging infections are shifting this longstanding paradigm. they lend further urgency to this area of research. in addition, these outbreaks have challenged our understanding of transmission dynamics. empirical observation has shown that there is not a single transmission force 'number' which completely characterized the spread of infectious diseases. this further complicates efforts to control infection within populations. in , a cluster of high mortality influenza cases was detected in mexico. an observational study of patients hospitalized in mexico between late march and june showed that pandemic (h n ) disproportionately affected young people. fifty-eight patients ( . % of those hospitalized) became critically ill, with complications including severe acute respiratory distress syndrome and shock. among those who became critically ill, the mortality rate was % (domínguez-cherit et al., ) . the pandemic and its management have been the subject of an in-depth analysis commissioned by the world health organization (who), and that analysis proved prescient in more recent global outbreak events such as ebola (who, ) . this cluster heralded a global pandemic and the declaration by who of a public health emergency of international concern (phiec). it occurred in the context of a decade of planning for a potential h n outbreak, which included who updating its pandemic guidance (pandemic influenza preparedness and response, ). in a small but lethal cluster of influenza occurred in children in a hong kong nursery. of the cases, died (mounts et al., ) . science shifted its understanding of influenza and recognized that flu could come directly from birds to humans. in fact h n , which emerged in , acquired the popular moniker of 'bird flu.' the outbreak was curtailed through active surveillance, changes in practice, and poultry culling of live markets in hong kong. however, the outbreak proved a harbinger of more widespread recognition of 'bird flu.' h n was identified through active surveillance of poultry and wild birds; waterfowl were particularly affected. human cases were sporadic but carried a very high mortality rate (estimated at %) (webster et al., ) . although the virus proved difficult to transmit to humans, case fatality was high. as of february , about laboratory-confirmed human cases had been reported to the who from countries; about % of reported cases were fatal. the spread of h n was geographically broad with extension into nigeria and throughout southern and se asia in waterfowl and in domestic fowl. extensive planning for a potential pandemic was put into place given the apparent proximity of the threat and the high mortality in humans. veterinary and human health collaboration was a central precept of this planning in the 'one health' concept (heymann and dixon, ) . the h n threat did not materialize despite the high level of circulation in birds. preparedness in se asia in particular included tabletop exercises, culling of birds through rapid response, and at least one joint investigation carried out between laos and thailand. in this setting, h n ran its course, with a milder clinical syndrome (although it is estimated that the global death toll was ). the pandemic of h n precipitated some confusion as well as competition for access to antivirals and vaccines. in the aftermath of these contentious discussions, new policy initiatives were put into place. this included the 'pandemic influenza preparedness' (pip) (who) plan which took some years to negotiate. it balances access to new viral strains for vaccine production with access to these vaccines for poor countries. the fineberg commission to examine an 'after action' performance of the international health regulations (ihr) was central to potential reform as well. this will be more fully discussed below. in a new influenza virus, h n , was isolated from patients in the people's republic of china. isolates were both from birds and from humans. although cases occurred globally with deaths, international spread was limited to two countries. the national response to this epidemic was very strong which is a key to control (discussed below). the influenza pandemic also followed another global respiratory emergency, sars. the etiology of sars (a new coronavirus) was not known in late when cases and deaths began to occur in guangdong province of the people's republic of china. initially misdesignated as a chlamydial pneumonia early in the course, public alarm mounted as antibiotics proved futile in treatment. between november and july , a total of probable sars cases were reported from countries with deaths for a mortality rate of . % (mmwr, ) . sars effectively demonstrated the potential mobility of respiratory pathogens. while sars was declared poorly transmissible, it effectively jumped continents in travelers and infiltrated populations through nosocomial spread. in contrast to influenza, which is highly transmissible, sars still requires direct exposure to bodily fluids for transmission. however, sars shifted the scientific paradigm of zoonotic transmission more fullywith incrimination of wet markets vending civet cats initially thought to be the source. this initial assessment has proved less robust in terms of 'reservoir' for new human pathogens as discussed below. sars also challenged our understanding of transmission dynamics. for reasons that remain unclear, a single infected person who spent a single night in a hotel in kowloon resulted in geographically broad transmission. the concept of a 'superspreader' was popularized (lloyd-smith et al., ) . this phenomenon was also described in a second scenario in beijing (shen et al., ) . traditionally infection has been characterized by a 'reproductive rate' which is essentially the rate at which an infectious case replaces itself. if the rate is , then there will be no spread, as the infection will simply stay the same absolute number as the index case recovers. however, if the rate is higher (i.e., > ), then spread into the population will occur as a single case infects multiple individuals so the number of cases increases. super-spreaders seem to have high infection rates although the overall rate for the pathogen in question may be low. this has, of course, changed our assumptions for modeling disease spread in populations. following the h n pandemic (and the avian influenza emergence of ) and the sars pandemic of , a new virus emerged on the arabian peninsula. mers-cov is a new human pathogen that also causes pneumonia and respiratory distress. the story of mers is less history and more present in terms of defining its epidemic potential. it reinforces the need for 'one health' collaboration between veterinarians, clinicians, and public health specialists, making use of their relative expertise. mers was first reported in as a case report of a patient in an icu with severe respiratory disease from jordan (hijawi et al., ) . at the time of this writing, cases and deaths have been reported to the who, with an average case fatality ratio of %. in one epidemiological analysis, the case fatality ratio for primary cases was % ( % ci, - ), whereas for secondary cases, it was % ( % ci, - ) (alsolamy, ) . like its coronavirus cousin, sars, mers-cov has demonstrated agile spread within hospitals (oboho et al., ) and across continents. in a large outbreak occurred in south korea (cowling et al., ) . that outbreak was characterized by a mortality rate of about % among cases, were fatal. it also featured 'superspreading' events. in fact a single case housed in the emergency room with persistent cough was linked to cases in one hospital (kucharski, ) . to summarize, the recent episodes of respiratory infectious diseases related to influenza, sars-cov, and mers-cov have demonstrated increasingly direct links between animal and human infections, agile intercontinental geographic spread, and complex transmission dynamics including 'superspreader' events. transmission within health-care settings has also been a prominent feature. these characteristics have challenged traditional assumptions about the pathogenesis and epidemiology of infectious diseases. traditionally microbiology has held that microbes (bacteria, viruses, protozoa, fungi, etc.) are organisms that replicate through genetic mechanisms. that replication is a major factor in the illness in humans these agents cause. recent emerging infectious events have brought an additional complexity into that decades' old assumption. a new form of a human neurodegenerative disease that emerged in britain in the s was linked to the emergence of bovine spongiform encephalitis (bse) in cattle ('mad cow disease'). this link was demonstrated through multiple casecontrol studies. the biological proof of a common etiology came somewhat later (hill et al., ) . prions are not microbial life in the traditional sense. they are 'autocatalytic proteins' or proteins that make change. in the instance of 'transmissible spongiform encephalopathies' (tses) of mad cow disease (bse), sheep 'scrapie,' elk chronic wasting disease, as well as in the human diseases of creutzfeldt-jakob disease (cjd), new variant creutzfeldt-jakob disease (vcjd) and kuru, these changes occur in the central nervous system. while the new vcjd epidemic related to ingestion of infected beef from bse-affected cows has waned due to enhanced global surveillance and animal husbandry practices, research into prion disease continues. it appears that despite their lack of genetic material, prions do undergo mutation and strain diversification in response to selective pressures (collinge et al., ) . soberingly, it is believed that some humans (estimated in britons) silently carry pathogenic prions for many years. this risk persists and creates safety concerns for blood transfusions and organ transplantation. the story of bse demonstrated the limitation of the traditional assumption that genetic reproduction of pathogens is necessary for infection as outlined above. the uk beef industry had historically been a relatively stable one when fragmented among many smaller farms across the british isles. to protect this industry, the government maintained a tariff on the imports of competing products from abroad. with the explosion of global trading in beef after world war ii, coincident with refrigerated transport, and the movement toward global free trade, the united kingdom negotiated a timetable under the general agreement on tariffs and trade to scale down tariffs on beef, which heightened competition in the uk beef industry and increased pressure for more efficient and less costly production methods. against this backdrop, innovation in rendering was introduced into the slaughterhouses of the united kingdom. the rendering or processing of carcasses of cows and other animals after the edible and usable bits of flesh and meat have been cut away has been done for centuries. and for decades, uk farmers used the meat and bone meal from rendering as a protein source for beef cattle. historically, the rendering process was similar to pressure cookingapplying very high temperatures for very long times so eventually even the bones broke down into powder. it was an expensive, fuel-consuming, and timeconsuming process. when a new cold vacuum extraction method of rendering was introduced requiring lower temperatures (i.e., less energy) and less time, it seemed a win-win situation considering the increasing pressure on the uk beef industry in the face of global competition. but sometime after the new rendering practice was introduced into the united kingdom, the prion disease known as mad cow disease emerged. the new process, discovered by uk beef industry, was not effectively disinfecting for prions. existence of prion disease was unknown prior to its dramatic emergence, first in cows and then in people. the context is important to appreciate. somehow the streamlining of the rendering process played a role. british scientists tested the new process by deliberately introducing animals with mad cow disease and assaying the resulting meat and bone meal product. they found that the newer rendering process does not remove the infection, whereas the older process did. zika virus emerged in sub-saharan africa in the late s. it is a close cousin of dengue virus and in the same family as yellow fever. all of these viruses are transmitted to humans through the bite of a mosquito. all of these diseases are clinically mild, but occasionally severe causing fever, rash, and joint pain. unfortunately all of these diseases have become globally distributed. zika is the most recent arrival in the americas. it has circulated in asia for some time (chen and hamer, ) . while clinically relatively mild, epidemiologic studies in brazil have suggested a link between zika virus and severe birth defects in newborns. viral infection in early pregnancy appears to be associated with microcephaly, which is associated with profound brain injury in newborns. again, the emergence of a new infectious disease is pushing the boundaries of biomedical knowledge. in the absence of certain prevention or treatment options, the government of brazil has gone as far as advising women not to become pregnant (mcneil, ) . the emergence of antimicrobial resistance has continued to be a major concern. in a new enzyme in gram-negative bacteria was detected which caused broad antibiotic resistance. this enzyme was produced by mobile genes that travel on plasmids. plasmids are small circular dna (genetic) packages, which are distinct from the dna of the bacteria itself. these are mobile, with the ability to be taken in across classes of bacteria if and when they confer a selective advantage for survival, as in the case of antimicrobial resistance. the new enzyme ndm- (new delhi metalloproteinase- ) was traced to an infection that occurred in patients who had been treated in india. a more complete study of the epidemiology of this enzyme in gram-negative bacterial isolates from the subcontinent suggested a broad range of gram-negatives were affected (kumarasamy et al., ) . this new biology, which was first described for extended spectrum beta lactamase (esbl) resistance in the s, has provoked renewed concern in antimicrobial resistance. was declared by the who as the year to address antimicrobial resistance. the pharmaceutical pipeline is bereft of new antibiotics to address this challenge. chillingly another new panresistant plasmid has been reported from china, which is resistant even to the last line of defense, the polymixin class of antimicrobials (liu et al., ) . this report included isolates from pigs at slaughter, retail pig and chicken meat, and humans. again, the specter of intensive agriculture fostering new biological threats calls for careful study. the isolates were largely from areas of intensive porcine agriculture in china. figure indicates sites sampled for polymixin plasmid resistance. the question of where new infections lurk in nature has been an active area of research. as noted above, the initial reservoir for sars coronavirus was thought to be civet cats which are domestically raised for food in china. however, further investigation has suggested that there may be a single host involved in many emergent diseases. in an elegant demonstration of interdisciplinary research, han et al. ( ) have recently published a persuasive article on the role of bats in emerging infections. whether or not the theses of the article prove true with further research, the work provides additional evidence of how extremely powerful interdisciplinary research can be toward solving the puzzles of emergent diseases in humans. in discussing the spillover of viruses from bats to humans, the authors write: factors that contribute to the intrusion of bats into human living environment can be summarized into a 'push' and a 'pull' (brüssow, ) . a 'push' refers to the enormous demand for more space and resources brought by the human population explosion, which leads to the destruction of bat habitats and shortage of food. natural environmental changes, such as typhoons and droughts, can also place stresses on bats. a 'pull' involves the living environments built by humans, characterized by urbanization, intensive agriculture and food animal breeding, which attracts bats into human living environments for an abundant of food supply. so coming full circle, this discussion highlights the critical importance of further understanding these events of 'species jumping' or 'spillovers,' given the pressures will only augment rather than abate. infections potentially housed in bats as their natural reservoir (from han and colleagues) is shown in table . it is an impressive array, which brings us to consider how indispensible further understanding in these interactions is to gain insight into emergent human infections. so what explains the apparent increased pace of emergence of new human infections? is it simply that we are more able, with our new technologies, to detect them? or are there forces at work that are fostering this trend? the stories of bse and nvcjd recounted above were outlined because the united kingdom, although a small country, has excellent epidemiologic, statistical, laboratory, and clinical acumen. while cases of bse and nvcjd were not confined to the united kingdom, the origin of emergence was tracked and described relatively efficiently. but, what of influenza? the potential contribution of intensive poultry and swine agriculture to the emergence of influenza a emergence was outlined in my earlier article for this publication. research over the past decade has continued to provide evidence of this risk. as intensive practices have spread to developing countries, the assurance of biosecurity has become less sure as noted in the discussion (above) of polymixin resistance through plasmids in pigs and humans. while many new strains of influenza arise in wild birds (particularly waterfowl), the link to human populations appears to be through domestic poultry (leibler et al., ) . however, other anthropogenic mechanisms are also at play. without the global 'mobile' environment of travel and trade, emergence would remain a largely local phenomenon. however, as we saw with the influenza discussion above that is not the case. nor was it the case with sars or with mers-cov. international tourism surpassed . billion arrivals in according to the world bank (world bank international tourism). after a slump in global trade during the global recession exports of food in reached nearly $ . trillion in value for selected countries where data were available. this, of course, does not include all of global trade, which has surpassed $ trillion in value (merchandise trade by product). guarding against transcontinental transmission in food or through human travel is a complex undertaking, with safeguards at the source the most likely answer. however, research, testing, and demonstration of effective measures remain wanting. finally, climate change, largely attributed to human activity, seems to be readjusting the boundaries of mosquito borne diseases. the recent incursion of zika into brazil is attributed to the el niño weather pattern now in force in that geography. while el niño oscillation is not directly attributable to human activity, the shifting of such natural oscillations and their severity may well be. in his landmark book planetary overload: global environmental change and the health of the human species, anthony j. mcmichael outlines the human-generated stress on natural systems (mcmichael, ) . he posits that food will become increasingly scarce for the human community. the macroecologic effects of human activity on climate, water, food, agriculture, pollution, and human health are well described, but the systematic link between the macrolevel (what we can see) and what is occurring on the microlevel remains an important area of research. to address the emergence of new pathogens, we need more precise knowledge about the mechanisms that form the critical pathway to emergence. a follow-up report to the landmark iom report, emerging infections, microbial threats to health: emergence detection and response was published in (smolinski et al.) (microbial threats to health) . additional factors of emergence were examined in this report: human susceptibility to infection, climate and weather, changing ecosystems, poverty and social inequity, war and famine, the lack of political will, and intent to harm. thus the original factors grew to . while enriching the discussion and description of emergence, this proliferation of factors also created overlapping domains within factors; for example, climate and weather are an integral physical science aspect of ecosystems, the failure of political will is integral to the neglect of public health systems, and so forth. from an analytic point of view, the need for in-depth study of factors and how they actually work has become critical for scientific insight into public health protection. mcmichael has suggested the term 'the anthropogenic epoch' to describe our contemporary situation. in other words, human kind is changing the nature of our environment in unprecedented ways. more recently the rockefeller-lancet commission has suggested the new scientific discipline of 'planetary health' as a unifying concept to bring the disparate strands of life sciences, and ecology more closely together to foster interdisciplinary research and insight (the rockefeller foundation, ). the key to success will require intense investment in transdisciplinary research which brings in disparate databases and talents into risk analysis. while a full discussion is beyond the scope of this discussion, a number of new tools have come into use that allow more rapid diagnosis and response to newly emergent outbreaks. a few will be highlighted here. in addition to formal disease surveillance reporting a number of informal diseases, surveillance networks have arisen among countries which share common borders or work within a common economic bloc. these networks facilitate the flow of information across borders and allow collaborative investigations, tabletop exercises, and resource sharing on an ongoing basis. in postconflict areas such as the mekong basin, they contribute to health security (gresham et al., ) . increasing sophistication of bringing disparate data sets together and creating models to understand possible scenarios has brought additional insight into prevention and control efforts for emerging diseases. prediction of where outbreaks are most likely to occur remains a very imperfect science (jones et al., ) . retrospective niche modeling has brought additional insight into how different factors may interact to foster outbreaks (daszak et al., ) . laboratory diagnosis of unknown agents has also advanced. during the sars outbreak, the who convened an informal network approach to fully sequence the new agent in -month time (david, ) . one group has put forward a vision of bringing full genomic sequencing into the laboratories of developing countries (aarestrup et al., ) . clearly the ability to quickly diagnose new agents without the necessity of culture would be an important advance. as importantly the integration of informatics linking genomic analyses to phylogenetic metadata would allow global tracking of agents. as the boundaries of microbiology are stretched with new insights from emergent diseases, the ability of the people of the world to protect against pandemics is more important than ever. global traffic and trade continue to grow, confounding national approaches with their international span. in (following sars) the who adopted the ihr (international health regulations). this is the only law with the force of an international treaty, which is in place to govern the conduct of countries during global security emergencies. the ihr outline 'core capacities' for national-level protection. it is not the optimal level for an emergent pandemic, but it is the minimum considered essential for global health security. the ihr implementation was to have been completed by all member countries by . however, implementation has languished with only one-third of countries implementing and many not disclosing their status of implementation to the who in . after the influenza pandemic, an independent expert panel was convened to assess how the ihr functioned. that panel, lead by dr harvey fineberg, then president of the institute of medicine, was explicit in outlining the gaps in global health security. the world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public-health emergency. beyond implementation of core public-health capacities called for in the ihr, global preparedness can be advanced through research, reliance on a multisectoral approach, strengthened health-care delivery systems, economic development in low and middle-income countries and improved health status. fineberg ( ) . in , ebola (a known infection) emerged in guinea. at the time of its appearance, none of the countries in sub-saharan africa had implemented the core capacities of the ihr (kimball and heymann, ) . the outbreak went on to create pandemonium in the three most affected countries (guinea, liberia, and sierra leone) killing over people (and afflicting more than ) (ebola-situation). infection was introduced in other countries, but onward transmission was limited. following ebola, the international systems are again under review. initial observations remain distressingly similar to those made in . with reform of the un and who, once again underway, it will be important to follow through. of particular importance as highlighted above is the interdisciplinary (and in the case of the un interagency) nature of prevention, detection, and response to emergent threats. despite the new technological tools, the ecological factors in emergence are ever gathering force. clearly additional efforts are required. emerging infections remain an intersectoral challenge with every indication they will continue to be with us over the coming decades. integrating genome-based informatics to modernize global disease monitoring, information sharing, and response middle east respiratory syndrome: knowledge to date zika virus: rapid spread in the western hemisphere preliminary epidemiological assessment of mers-cov outbreak in south korea interdisciplinary approaches to understanding disease emergence: the past, present, and future drivers of nipah virus emergence the international response to the outbreak of sars in critically ill patients with influenza a(h n ) in mexico pandemic preparedness and responsedlessons from the h n influenza of creating a global dialogue on infectious disease surveillance: connecting organizations for regional disease surveillance (cords). emerg bats as reservoirs of severe emerging infectious diseases the value of the one health approach: shifting from emergency response to prevention of zoonotic disease threats at their source epidemiological findings from a retrospective investigation the same prion strain causes vcjd and bse global trends in emerging infectious diseases ebola, international health regulations and global safety factors influencing the emergence of new (and "old") disease, international encyclopedia of pubic health superspreading in mers emergence of a new antibiotic resistance mechanism in india, pakistan and the uk: a molecular, biological and epidemiological study industrial food animal production and global health risks: exploring the ecosystems and economics of avian influenza emergence of plasmid-mediated colistin resistance mechanism mcr- in animals and human beings in china: a microbiological and molecular biological study superspreading and the effect of individual variation on disease emergence planetary overload global environmental change and the health of the human species zika virus, a mosquito-borne infection, may threaten brazil's newborns global health microbial threats to health: emergence, detection, and response by committee on emerging microbial threats to health in the st century update: severe acute respiratory syndrome -worldwide u.s case-control study of risk factors for avian influenza a (h n ) disease, hong kong mers-cov outbreak in jeddah-a link to health care facilities a who guidance document. world health organization the rockefeller foundation-lancet commission on planetary health safeguarding human health in the anthropocene epoch: report of the rockefeller foundation-lancet commission on planetary health h n outbreaks and enzootic influenza report of the review committee on the functioning of the international health regulations the author wishes to thank ms kellie creamer for her assistance in preparing this manuscript.see also: antimicrobial resistance in a one health and one world perspective -mechanisms and solutions; arboviruses; ebola and other viral hemorrhagic fevers; global health law: international law and public health policy; influenza. key: cord- -fbfe vt authors: wallis, christopher j.d.; catto, james w.f.; finelli, antonio; glaser, adam w.; gore, john l.; loeb, stacy; morgan, todd m.; morgans, alicia k.; mottet, nicolas; neal, richard; o’brien, tim; odisho, anobel y.; powles, thomas; skolarus, ted a.; smith, angela b.; szabados, bernadett; klaassen, zachary; spratt, daniel e. title: the impact of the covid- pandemic on genitourinary cancer care: re-envisioning the future date: - - journal: eur urol doi: . /j.eururo. . . sha: doc_id: cord_uid: fbfe vt context: the coronavirus disease (covid- ) pandemic necessitated rapid changes in medical practice. many of these changes may add value to care, creating opportunities going forward. objective: to provide an evidence-informed, expert-derived review of genitourinary cancer care moving forward following the initial covid- pandemic. evidence acquisition: a collaborative narrative review was conducted using literature published through may (pubmed), which comprised three main topics: reduced in-person interactions arguing for increasing virtual and image-based care, optimisation of the delivery of care, and the effect of covid- in health care facilities on decision-making by patients and their families. evidence synthesis: patterns of care will evolve following the covid- pandemic. telemedicine, virtual care, and telemonitoring will increase and could offer broader access to multidisciplinary expertise without increasing costs. comprehensive and integrative telehealth solutions will be necessary, and should consider patients’ mental health and access differences due to socioeconomic status. investigations and treatments will need to maximise efficiency and minimise health care interactions. solutions such as one stop clinics, day case surgery, hypofractionated radiotherapy, and oral or less frequent drug dosing will be preferred. the pandemic necessitated a triage of those patients whose treatment should be expedited, delayed, or avoided, and may persist with severe acute respiratory syndrome coronavirus- (sars-cov- ) in circulation. patients whose demographic characteristics are at the highest risk of complications from covid- may re-evaluate the benefit of intervention for less aggressive cancers. clinical research will need to accommodate virtual care and trial participation. research dissemination and medical education will increasingly utilise virtual platforms, limiting in-person professional engagement; ensure data dissemination; and aim to enhance patient engagement. conclusions: the covid- pandemic will have lasting effects on the delivery of health care. these changes offer opportunities to improve access, delivery, and the value of care for patients with genitourinary cancers but raise concerns that physicians and health administrators must consider in order to ensure equitable access to care. patient summary: the coronavirus disease (covid- ) pandemic has dramatically changed the care provided to many patients with genitourinary cancers. this has necessitated a transition to telemedicine, changes in threshold or delays in many treatments, and an opportunity to reimagine patient care to maintain safety and improve value moving forward. the rapid spread of coronavirus disease caused by the novel severe acute respiratory syndrome coronavirus- (sars-cov- ) has had dramatic effects on individuals and health care systems [ ] . patients with cancer have been impacted directly by the virus, felt the consequences of covid- -focused health care, and have often experienced treatment [ , ] . among patients with covid- , those with a history of cancer have a significantly increased risk of severe outcomes [ ] . covid- triage guidelines have often recommended reductions in the use of systemic chemotherapies and approaches that may compromise an individual's immunity [ , ] . a severe sars-cov- phenotype is seen more commonly in men and those of advanced age or comorbid conditions [ , [ ] [ ] [ ] [ ] . to a large extent, these demographics mirror the patient population at risk for genitourinary cancers. medical and economic consequences of covid- necessitate urgent changes in the delivery of health care to reallocate or redeploy staff. furthermore, the large financial loss to various institutions has necessitated reductions in workforce. covid-related policies and recommendations have been put in place surrounding social distancing, which have further reduced patients entering the health care system. this has resulted in deferral of cancer diagnosis, work-up, treatment, and in-person contact. basic as well as clinical research has been curtailed significantly. the net effect has resulted in a financial downfall in the global economy and health care systems. the true impact of the pandemic has yet to be realised fully, and will include the impact of delays in diagnosis and treatment for many cancers, which may influence cancer-related quality of life. the solutions adopted to navigate the covid- pandemic include temporisation (to defer medical care until health care capacity recovers) and more lasting changes. it is unlikely that medical practice will return to pre-covid- patterns in the near future. we should anticipate persistent community-level viral spread and intermittent exacerbations. here, we highlight changes in the care of patients with genitourinary cancers as a result of the covid- pandemic and opportunities to reimagine care delivery. evidence acquisition the first and senior authors proposed a framework that was iteratively revised by all coauthors. a search of pubmed from inception until may , was performed for each topic using mesh subject headings along with free-text, related, derivative, and exploded terms. the available data were synthesised qualitatively. where available, we relied on previously published systematic reviews and meta-analyses, supplemented by narrative review of key studies. the first and senior authors drafted this narrative review, which was critically revised by all coauthors. the final manuscript represents the consensus of the authors. acknowledging an expected paucity of high-quality data for many included topics within the scope of this review, we offer an expert opinion where relevant and feasible. several themes emerged during the covid- pandemic that would be critical or beneficial to genitourinary cancer care in the future ( fig. ) : first, reduced in-person interactions argued for increasing virtual and image-based care; second, optimising the delivery of care to include better triage, understanding and addressing mental health implications due to less in-person care, and maintaining high-quality research and education endeavours are necessary; and third, the presence of sars-cov- in health care facilities may affect decision-making by patients and their families. social distancing has formed the backbone of public health responses to the covid- pandemic. although office visits have been supplanted by telemedicine, e-consults, virtual care, hospital-at-home approaches with early discharge and remote monitoring, and virtual conferences/tumour boards [ ] , these approaches offer improved access to expert care and reduced travel burdens for patients [ , ] . prior to covid- , telemedicine was uncommon in urology and most studies focused on prostate cancer [ , ] . telemedicine was used to supplement rather than replace inperson interactions. schaffert et al [ ] developed an online tutorial to assist and prepare patients in treatment decisionmaking. a similar approach utilised the personal patient profile-prostate (p p) in a multicentre randomised trial [ ] . when compared with "usual care", the p p intervention was associated with less decision conflict. in a randomised trial, a telephone-based intervention was better than written materials in modifying dietary behaviour [ ] . each of these studies demonstrates the added value of remote interactions. telemedicine has also been used in survivorship. skolarus and colleagues [ ] randomised patients, - yr following treatment, to a personally tailored, automated telephone symptom management intervention or usual care. patients receiving the tailored intervention had nonsignificant improvements in epic scores (all domains). in contrast, viers et al [ ] reported little difference in a randomised comparison of telemedicine and traditional office-based consultations after radical prostatectomy, although those receiving telemedicine reported lower travel costs and less time off work. leahy et al [ ] showed similar satisfaction after radiotherapy for nurse-led telephone consultations to standard office visits. recently, belarmino and colleagues [ ] demonstrated a smartphone app for monitoring of postoperative recovery and kegel teaching following prostatectomy. lange et al [ ] offered some cautionary data demonstrating poorer psychological outcomes for patients utilising an online peer chat group compared with usual care. a number of other studies have assessed the feasibility of behavioural interventions (predominantly in activity/exercise engagement) in patients with prostate cancer [ , ] . taken together, these studies demonstrate that remote virtual care can feasibly replace part (but not all) of in-person clinician interactions. clinical examination is an important component of medicine. during the covid pandemic, many consultations became virtual and we expect some of these to persist in the future. while for some patients, including those with advanced cancers on systemic therapy, physical examination has an important role, for many, including those with early-stage malignancies, treatment decisions are based on history, laboratory, and imaging results. digital rectal examination (dre) is a common component of prostate cancer management, but has an uncertain value. in the context of multiparametric magnetic resonance imaging (mpmri), incremental benefit of dre is unknown. philip and colleagues [ ] demonstrated little correlation between dre and biopsy findings/pathological stage. others have demonstrated low sensitivity/specificity of dre in cancer screening [ ] , and few patients are reclassified or receive intervention for dre findings alone within active surveillance (as; . % in toronto [ ] ). following local therapy, oncological recurrence is determined primarily based on prostate-specific antigen (psa) results. thus, omission of dre in patients with prostate cancer may be reasonable, within the context of virtual care. for kidney cancer, initial treatment decisions and surveillance are primarily predicated on imaging results rather than on physical examination. similarly, in the initial consultation and on-going surveillance for bladder cancer, in-office physical examination is rarely contributory to disease management. however, in-office cystoscopy is likely to be influential in treatment decisions and long-term surveillance for those with bladder cancer, though emerging data suggest that e u r o p e a n u r o l o g y x x x ( ) x x x -x x x biomarker-based surveillance may be changing this [ ] . in contrast, physical examination is important for penile and testis cancers and is likely to remain influential, at least in the short term. telemedicine offers benefits over standard care [ ] . the primary care literature has identified younger patient age, ethnic minorities, full-time employment, and long commutes to work as barriers to patient access [ ] . telemedicine may obviate these [ , ] . telemedicine is also less time consuming (for the patient and the physician) and facilitates visits outside of normal daytime clinic hours, expanding access to care for patients unable to take time off work. telemedicine may allow tertiary level care to patients in remote regions, potentially reducing geographic disparities in care. additionally, virtual care has the potential to positively impact carbon emissions. consultation at virtual multidisciplinary clinics facilitates high-value prostate cancer care, including better targeting of interventions to disease risk [ ] [ ] [ ] [ ] . this approach can easily be expanded, so all patients benefit without the physical barriers or need for multiple appointments [ ] . however, reliance on telemedicine is not without risk [ ] . conveying information on adverse prognosis through a telemedicine portal may inadequately guard the sensitive nature of these challenging conversations [ ] . the original spikes protocol for breaking bad news stressed the important of a proper setting for disclosing serious news, even highlighting the importance of eye contact and physician contact [ ] . a virtual visit may lose nonverbal clues to emphasise human connection. although telemedicine can reduce current barriers to care, it may exacerbate a digital divide if tools are not sensitive to patient health literacy, language, and technological capabilities. patients need sufficient technology and expertise, and many tools are available only in english. these may be barriers for economically disadvantaged and older patients. privacy concerns are less prevalent, given that many platforms are compliant with privacy standards and regulations. there may be a widening disparity between health care systems that can invest/maintain telehealth solutions and smaller practices that cannot. the economic impact of telemedicine is currently unclear [ , ] . there has been little study of patient comprehension or engagement during video visits. in addition to these patient-facing barriers and risks, there are pragmatic limitations from the provider and health system perspective, including the availability of telemedicine platforms that are compliant with jurisdictional privacy requirements and the question of billing or remuneration for these interactions. for physicians who are salaried, this is less of a concern; however, the on-going acceptance of telemedicine billings from payers will clearly influence the viability of this approach going forward. finally, the role of trainees and advanced practice providers in telehealth remains uncertain. this may have implications for both trainees' educational exposure and clinic workflow. it can be challenging to oversee a trainee or other care providers in a virtual setting, and provide realtime teaching. in the experience of some of this article's authors, trainees may be integrated into the telemedicine consultation process, though with a loss of fluidity. as experience has evolved, utilisation of telemedicine approaches appears to vary across jurisdictions, with traditional, in-person interactions returning to prominence in some regions, while others remain nearly exclusively virtual. telemonitoring is defined as the digital transmission of physiological data. systematic reviews have found that early hospital discharge with home-based postoperative care may reduce pressure on acute hospital beds [ ] , increase the time from discharge to readmission, reduce costs, and improve health-related quality of life [ ] . treatment at home is associated with improved functional outcomes for older patients deemed at need for hospital admission [ ] and significant cost savings, particularly for the most advanced cancers [ ] . this approach may offer the greatest benefit in patients following radical cystectomy who typically have prolonged hospitalisations and are at risk of readmission [ , ] . initial pilot work has demonstrated the feasibility of using remote monitoring applications, such as personal activity trackers, wearables, and smartphone applications for perioperative monitoring [ ] [ ] [ ] . further work is needed to clarify the sensitivity, intensity, and balance of telemonitoring/in-person visits [ , ] . such approaches may decrease the need for postdischarge nursing homes [ ] . although "hospital-at-home" approaches have been described in the literature for well over yr [ ] , on-going advances in technology, including wearable devices that can track physiological parameters including most vital signs, have recently improved the level of care that may be provided at home [ , ] . many centres have transitioned to remote multidisciplinary tumour boards. these allow access to the improvements in care derived from such boards [ ] [ ] [ ] [ ] , without logistical barriers [ ] . on-going use of this approach would allow involvement of clinicians in geographically remote locations, thus facilitating community providers (who know their patients best of all) who cannot interrupt their practice to physically a university board. electronic consults (econsults) allow for asynchronous interactions between two physicians (consulter and consultee) and improve access to specialty expertise without the need for face-to-face visits [ ] [ ] [ ] . this approach allows timely access to expertise, is well received by primary care providers [ ] , and can overcome physical space limitations, while allowing flexible scheduling of outpatient care (not restricted by clinic space availability, outside traditional hours, and interspersed during operating day downtimes). although clinical decision support systems can provide real-time recommendations, an automated digital patient engagement platform can help patients manage acute, chronic, or periprocedural care, while also automating simple workflows (such as verifying undetectable postprostatectomy psa at specified intervals) [ ] [ ] [ ] . social distancing has changed education dramatically [ ] . the transition to virtual teaching for educational seminars has allowed wider dissemination of expertise, including in formats such as the urology collaborative online video didactics (covid; http://urologycovid.ucsf. edu) and educational multi-institutional program for instructing residents (empire), which can be viewed both live or as a previously recorded content, and create a valuable library of content. whereas this type of content was previously expensive to view and managed by medical publishers, this open publishing model has democratised access to expert content. the annual meetings for european association of urology (eau), european society for medical oncology, american association for cancer research, american society of clinical oncology, american urological association, radiological society of north america, and american society for radiation oncology have all been converted to a virtual format [ ] . the virtual format will reduce costs of travel and housing, and allow for more convenient interaction of the various contents provided. a continuation of these collaborative efforts offers the opportunity to enrich training and education moving forward. the loss of in-person interactions may have significant implications from less social networking (may be particularly important for trainees and junior faculty seeking to make connections beyond their institution), fewer ad hoc discussions and resultant collaborations, a potential decrease in interactivity and engagement, and the loss of the social component of conference participation. finally, on-going technological innovations may facilitate spread of evidence-based medicine and knowledge sharing about genitourinary malignancy. for example, a twitter-based journal club about prostate cancer (#prostatejc) has been shown to foster global multidisciplinary discussions about important new research [ ] . unlike traditional journal clubs that are typically limited to a single specialty and institution, use of social media enables participation from different types of providers from many institutions and countries, as well as other stakeholders (eg, patients and advocacy groups). social media have also been used for successful dissemination of the eau clinical guidelines [ ] . despite the great potential for digital platforms to facilitate evidence-based practices in genitourinary care, there are also risks including a potential for spread of biased and/or misinformative content [ ] . moving forward, it is important for health care providers in genitourinary oncology to direct patients to high-quality online resources and to participate actively in public dissemination of evidence-based information. the covid- pandemic has forced a rapid transition to telemedicine and teleconferencing. inevitably, some physicians and patients will prefer in-person consultations. however, a thoughtful and targeted increase in telemedicine and teleconferencing offers the potential to decrease the time and financial burden of physician visits, reduce geographic barriers to tertiary and quaternary care expertise for patients with genitourinary cancer, and free up valuable clinic space. further investigation is required to ensure that these approaches do not raise new barriers to care, compromise patient safety, impede education of trainees, or lead to inferior disease control outcomes. the educational-and service-based role of trainees in telemedicine remains to be resolved. where in-person interactions remain necessary or desirable, the on-going influence of covid- is likely to persist. moving forward, in addition to current changes including limits on individuals accompanying or visiting patients and preinteraction screening, architectural redesign of clinics, hospitals, and other treatment facilities to reduce close personal contact may be prudent. optimising treatment selection the covid- pandemic necessitated a review of what care we provide for genitourinary cancers [ ] [ ] [ ] [ ] , patients for whom treatment should be expedited, those who can have treatment safely delayed, and those who should have expectant noninterventional management. this refocus offers the potential to increase the value of care for both virtual and in-person delivery. surveillance strategies rely on understanding competing risks (morbidity of treatment vs mortality from cancer) and other influences (age and comorbidity) [ ] . covid- has focused attention on noncancer morbidity/mortality in patients whose demographic characteristics are those at the highest risk of complications from sars-cov- [ , ] . consequently, such patients may re-evaluate the risk/benefits of hospital interventions for low-to moderate-risk cancers. as is widely accepted for patients with low/favourable intermediate-risk prostate cancer [ ] , small renal masses [ , ] , and low-grade non-muscle-invasive bladder cancer (nmibc) [ ] . data will be produced in coming years that analyse the impact of treatment delays on early-stage cancers. if significant delays in treatment or surveillance do not impact long-term outcomes adversely, it will provide evidence for expanding the use of surveillance and potentially de-escalating the intensity of the surveillance regimens themselves. the covid- pandemic focused attention on ways to maximise the efficiency of treatment and minimise health care interactions [ ] . going forward, patient care must simultaneously be of high quality while minimising the risks of covid- . patients with advanced cancer and those on chemotherapy are at a higher risk of adverse outcomes from sars-cov- [ ] . treatment decisions are complex and will need to be tailor made for the current rate of infection, the risk of cancer, and the potential benefit/risk of treatment. for prostate cancer radiotherapy, hypofractionation has demonstrated equivalent oncological (metastasis-free, dis-e u r o p e a n u r o l o g y x x x ( ) x x x -x x x ease-specific, and overall survival) and functional outcomes as longer regimens [ ] . while utilisation of hypofractionation is limited [ ] , often for nonclinical reasons (eg, reimbursement), its use should be encouraged. similarly, the use of long-duration formulations of androgen-deprivation therapy ( , , or monthly) should be recommended [ , ] to minimise visits and patients' burden of care. for patients with nmibc, the covid- pandemic has prompted re-evaluation of bacillus calmette-guérin (bcg) and intravesical schedules [ ] . prioritisation of resources and visits to the induction and early maintenance courses [ ] may offer an opportunity to decrease patient burden and cost. a recently published cost-effectiveness analysis demonstrated that, even in the absence of covid- , maintenance bcg is not cost effective [ ] . in patients undergoing surgery, the question of minimally invasive (laparoscopic or robotic) approaches compared with open surgery was a concern early in the covid- pandemic, as such an approach was initially considered an aerosol-generating procedure [ ] . however, subsequent guidance from the society of american gastrointestinal and endoscopic surgeons (sages) clarified that there was no evidence of aerosolisation of blood-borne covid- particles. sages recommended the use of filtration for co released from laparoscopy, as well as minimisation of port incision size and insufflation pressure, but highlighted that many advantages of a minimally invasive approach, including reduced length of stay and decreased complication rates, may be particularly advantageous in the setting of strained health care resources due to the pandemic [ ] . multiple health organisations have developed guidelines that aid in patient selection and management (table ) . while pragmatic, these are rarely evidence based due to the lack of data and rely on contributions from key opinion leaders in the field. these guidelines should not necessarily be adhered to strictly and are often not contemporary as the health care environment and sars-cov- prevalence change rapidly. overall, the goal is to treat cancer patients with as close to standard therapies as possible once the risk/ benefit ratio has been considered. there are multiple clinical scenarios where less intensive medical care may be oncologically equivalent (or marginally worse) but involves far fewer health care interactions. for example, as for low-risk prostate cancer places a high burden on patients/their providers (frequent consultations, repeat biopsies, and mpmri), with multiple hospital visits over many years. if selected accurately, few men leave as and many avoid any intervention. the protect trial offered a low-intensity approach (regular psa tests, but neither confirmatory biopsy nor mpmri) without demonstrable differences in mortality with radical treatments at yr [ ] , suggesting that less intensive as may not compromise survival. the follow-up postradical treatment for prostate cancer is grounded in patient-reported outcomes and psa measurements. in an era of virtual care, automated algorithms can provide recommendations for patients with good quality of life and no evidence of disease recurrence, and those who do not feel the need for follow-up. these solutions will reduce unnecessary visits, increase compliance with follow-up, and potentially provide triggers for further assessment (eg, meaningful changes in quality of life or psa). guidelines suggest that it may be safe to discharge patients with low-grade nmibc as early as mo if they remain recurrence free [ , ] . even with high-risk nmibc, patients who underwent low-intensity cystoscopic surveillance (below that recommended in guidelines) had no increased risk of progression or bladder cancer-related mortality while undergoing fewer transurethral resections [ ] . while these data remain to be validated prospectively, they certainly suggest that surveillance may be de-escalated compared with current practices. finally, among patients with surgically treated kidney cancer and muscle-invasive bladder cancer, an algorithm has been developed for individualised risk-stratified postoperative surveillance with optimised imaging intervals by considering the interplay between the competing risks of recurrence and other-cause mortality [ , ] . the covid- pandemic offers long-term improvements in the value of care for patients with genitourinary cancer. clinicians and patients should become more attuned to the following principles require careful consideration when deciding on systemic cancer treatments [ ] : prioritise patients receiving treatment with curative intent (eg, testis cancer). these patients should remain on an uninterrupted treatment pathway, starting unaltered treatment regimens with negligible delays. consider any impact of delaying treatment on primary outcomes (eg, overall survival, cancer-specific survival, risk of progression of disease, and quality of life). assuming that the pandemic will continue until the end of - , administering treatment in the noncurative setting, where existing treatment regimens provide an absolute survival benefit of < mo, is associated with risks and should be decided on a case by case basis. treatment regimens with a high risk of febrile neutropenia should be optimised by dose reduction and by the use of granulocyte-colony stimulating factors or prophylactic antibiotics where appropriate. treatments with important risk of toxicity (high-dose chemotherapy and immune checkpoint inhibitors) should be started only if local health services are able to manage treatment-emergent side effects. neoadjuvant and adjuvant regimens require careful attention and should be administered only if they provide proven survival benefits. they should be omitted in scenarios with insufficient data for survival benefit (adjuvant therapy in urothelial cancer). in all cases, the health status of the patient and risks associated with covid- (age, presence of comorbidities, and increased risk of complications) should be taken into account when deciding on treatment. there will be patients whose diagnosis or treatment initiation was compromised due to the pandemic and thus they experience upstaging or disease progression, compromising their chances of survival. the psychological burden caused by this should be addressed. pcr testing and/or antibody testing should be performed before starting therapy where possible. covid- = coronavirus disease ; pcr = polymerase chain reaction. e u r o p e a n u r o l o g y x x x ( ) x x x -x x x competing (noncancer) causes of morbidity and mortality. consideration of these may identify cases where expectant approaches are preferable. decreasing health care resources for patients at a low risk of morbidity/mortality due to their genitourinary cancers (low-value care) offers the opportunity to increase resources available to deliver high-value care. among patients who require treatment, there are approaches that may reduce patient and health system burden while offering equivalent outcomes. patients, providers, and health systems will need to reimagine cancer care, understanding that this is not "rationing" but higher value for all stakeholders. social distancing has contributed to significant mental health issues including stress, loss of motivation, loss of meaning, and loss of self-worth [ , ] . this may exacerbate known effects of cancer diagnosis, including significant emotional distress manifest as anxiety, depression, or anger [ , ] . women and younger patients may be particularly susceptible [ ] . in an era in which social supports are stretched or broken, this effect may be magnified, particularly in the context of telemedicine that can be impersonal [ ] and in which physicians may not read body language to identify those struggling to cope. for patients with expectant strategies, the concept of forgoing treatment of a cancer may be associated with an added psychological burden. in the context of as for prostate cancer, there is a mixed literature assessing the mental health burden of this treatment approach [ , ] . some studies suggest increased rates of anxiety and depression [ ] , while others suggest that these rates diminish over time [ ] . similar effects are noted within surveillance for small renal masses and biopsy-proven renal malignancies [ , ] . research and tools are needed to understand how best to address psychological and behavioural issues resulting from a transition to a "less is more" approach. an example of this is the reassureme study (nct ), a randomised controlled trial evaluating the psychological impact of mindfulness-based stress reduction in prostate cancer patients (and their partners) under as. the active treatment of genitourinary cancers is associated with mental health effects, particularly from incontinence and erectile dysfunction after prostate cancer and the body-changing effects of radical cystectomy [ ] [ ] [ ] , though similar effects have been seen following surgery for kidney cancer, particularly among women [ ] . a loss of perceived support from treating physicians because of decreased in-person interaction may exacerbate these. finally, patients with pre-existing psychiatric disorders have been shown to have worse cancer-related outcomes [ , ] . this highlights that these patients require physicians to be more engaged than usual following diagnosis and treatment. given that social distancing and telemedicine may increase barriers to care for patients with psychiatric disease and may weaken the coping mechanisms of those without pre-existing psychiatric disease due to loss of social networks, consideration of the mental health implications of the changes in medical practice warrant careful consideration. conversely, telehealth approaches may be used to address mental health issues and remediate disparities in access to these critical services [ ] . the need for repeated in-person interactions has hampered on-going accrual and conduct of prospective research during the covid- pandemic. in many regions, accrual has entirely stopped, and research-related personnel/ resources have been redirected into covid-related care and research. however, this pandemic has allowed a refocusing of research priorities. first, the pandemic has highlighted the critical role of biomedical research in society and within everyday care of our patients. for cancer patients, including those within bench research, clinical trials, observational studies, realworld effectiveness of agents, and randomised trials, support is derived from research staff and well-being from knowledge that you are helping other patients [ ] . second, the rapid emergence of consortia, such as the covid- and cancer consortium (ccc ) and the covid-surg collaborative [ ] , has demonstrated that modes of research may change and it is feasible to recruit large numbers of patients quickly. third, the social distancing required because of covid- has mandated changes to research conduct, including the use of electronic consent, telemonitoring, and digital survey tools. in , galsky and colleagues [ ] reported the feasibility of a telemedicine-based interventional oncology trial. following a single, in-person enrolment visit, the investigators utilised telehealth interactions using a smartphone-based platform for on-going follow-up in their trial of metformin in patients with biochemically recurrent prostate cancer. combined with laboratory monitoring closer to home, such an approach offers the potential to reduce many currently mandated monitoring visits. in addition to the implications for the patient-facing portion of research, a move to teleinteractions offers the opportunity for research coordinators to work remotely, reducing the geographic footprint required. together, these changes can increase the efficiency of a research enterprise. fourth, the pandemic and associated contraction of research enterprises offer the potential to examine how we prioritise research efforts and funding. sars-cov- in the evolving covid- pandemic the emergence from the current covid- pandemic is uncertain. numerous potential outcomes have been postulated regarding the natural history of this disease, including annual waves, similar to influenza, to waxing and waning courses due to social distancing and travel restrictions. barring a highly efficacious vaccine, it seems unlikely that covid- will disappear, and thus, moving forward, it is likely that the risks of viral transmission will continue to affect the practice of medicine and biomedical research. within the constraints imposed by managing covid- , it is important to consider how we may best optimise the care of patients with genitourinary cancer. the covid- pandemic has dramatically altered the social structure of our society and the care of patients across the world. there has been a rapid transition to telemedicine and a triage reprioritisation of care. owing to resource requirements, health care changes as a result of the covid- pandemic have disproportionally affected patients receiving surgical care [ ] . as these changes may result in care delivery models that differ dramatically from previous approaches, consideration of the mental health impacts on patients and clinical teams, and the potential to magnify health care disparities is critical. finally, social distancing has necessitated changes in the conduct and presentation of research. from a physician's perspective, the medicolegal implications of an abrupt change in practice patterns (from in-person interactions to telemedicine) and potentially in treatment recommendations, including delaying recommended cancer treatments, are unclear and require a societal-level consideration of the social contract between physicians and patients. this will likely differ significantly between countries and requires a considered approach. as we anticipate health care in the post-covid era, lessons learned from this experience may improve care for patients with genitourinary cancers moving forward if we choose to act upon them. first, careful adoption and implementation of telemedicine may reduce the time and cost burden on patients associated with physicians' visits, while also reducing geographic barriers to expertise and environmental impact. however, it is important to understand the new barriers and disparities that a transition to telemedicine may cause. second, an increased focus on the role of expectant management approaches to patients with genitourinary cancers offers the potential to reduce lowvalue care, which, in turn, may increase available resources for high-value interventions. however, we need to be cognizant that, in utilising approaches that reduce contact between patients and physicians, we do not leave patients feeling abandoned, with associated mental health implications. moving forward, rather than complete resolution of the covid- pandemic, it is likely that we will reach a steady state with an on-going lower prevalence of infection in the community, punctuated by intermittent periods of strained health care resources and urgency. during these calm periods, it will be important to prioritise the care of patients who are most likely to suffer harm if they are unable to receive treatment during the periods of health care strain [ ] . initial barriers to care, including a lack of personal protective equipment and an inability to provide large-scale testing for both patients and health care personnel, will, for the most part, be mitigated during these relatively "calm periods". further, utilisation of routine preoperative testing should obviate the need to delay surgical care due to concerns of perioperative covid-related morbidity or mortality. however, as experience in the usa continues to show, severe outbreaks that threaten health care systems' capacity continue to be a threat moving forward. restructuring of health care networks (including the use of hubspoke models) may allow for maintenance of "covid- free" health care facilities to provide on-going treatment during times of covid- -related health care pressure, as well as providing a model for on-going care in the face of future pandemics with novel pathogens. anecdotal evidence is emerging that many patients have delayed care both in a primary care setting and in the emergency department as a result the covid- pandemic [ ] . these delays may arise due to fear of patients from health care interaction (which may or may not dissipate over time), physician reassignments (which are expected to improve over time, but at the peak affected one-quarter of urologists surveyed [ ] ), and institutional and government policies limiting diagnostic procedures such as cystoscopy and biopsy [ ] (which again would be expected to improve over time). in the short term, as we emerge from this initial wave of the pandemic, numerous authors of this review have noted decreased referrals. this may reflect patients deferring presentation for symptoms that lead to new cancer diagnoses (eg, abdominal pain leading to diagnosis of kidney cancer or haematuria leading to diagnosis of bladder cancer) and decreased routine health care (eg, psa screening during routine health maintenance examinations) or simply prioritisation of health care resources to the care of patients with covid- . modelling studies from the uk suggest that delaying cancer surgery by mo for patients with incident diagnoses would mitigate between % and % of the 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pregnant during a disease outbreak may add extra anxiety and concern for pregnant women and for those who provide care for them [ , ]. during the initial stages of the pandemic, it appeared africa would be spared the burden of covid- . however, by april th, a total of countries within the who african region had reported over cases (although some place it at over ), with at least deaths and people recovered. ethiopia, being one of the developing countries trying to address the diverse needs of its people, is currently at the verge of the epidemic [ , ]. objectives: the general objective of this study was to assess the impact of covid- infection on maternal and reproductive health care services among mothers getting service in governmental health institutions of dessie town, g.c. methods: institution based cross sectional study design using mixed (quantitative supplemented with qualitative) method was employed to identify the impact of covid- infection on maternal and reproductive health care services among women who get service in governmental health institutions of dessie town. the study was conducted from july - / . result: according to this study, six percent ( %) of antenatal care attendees, % of delivery care attendees and nearly half ( . %) of postnatal care attendees reported inappropriate service delivery due to fear of health care providers, shortage medical supplies and staff work load. the study also showed that utilization of these services was decreased due to fear of clients to go to health institutions. conclusion and recommendation: this study concluded that covid- significantly affects the quality and utilization of maternal and reproductive health care services. the study also showed that utilization of these services was decreased due to fear of clients to go to health institutions. ministry of health should continue maternity and reproductive health care services such as family planning to be prioritized as an essential core health service. key words: covid- , impact, antenatal care, dessie the covid- pandemic has in a matter of weeks fundamentally crippled health systems in many countries and is now threatening to cause a global economic depression. this in turn is having an unprecedented impact on health care organizations' ability to provide emergency care and on societies to provide core functions of the state. the covid pandemic is causing huge stress on the health care system of all countries in the world. the impact of the pandemic is both social and economic. ethiopia, being one of the developing countries, is currently at the verge of the epidemic [ , , and ] . pregnancy is an exciting and sometimes stressful experience. being pregnant during a disease outbreak may add extra anxiety and concern for pregnant women and for those who provide care for them. currently, the virus is thought to be spread from an infected person to others by respiratory droplets when a person coughs or sneezes and is in close contact with another person. according to the cdc, it is not clearly known if pregnant people are more susceptible to covid- than the general public. due to changes that occur during pregnancy, pregnant people may be more susceptible to viral respiratory infections [ , , and ] . there is no current evidence of adverse effects on pregnant women from covid- . the physical and immune system changes that occur during and after pregnancy should however be taken into account. it is critical that all women have access to safe birth, the continuum of antenatal and postnatal care, including screening tests according to national guidelines and standards, especially in epicenters of the pandemic, where access to services for pregnant women, women in labour and delivery, and lactating women is negatively impacted [ , ] . dealing with covid- is likely to create imbalances in health care provision, disruption of routine essential services and to require redeployment of scarce health personnel across health services. acute and emergency maternal and reproductive health services may be hit hardest, with limited facilities for isolation areas to assess and care for women in labour and the newborn [ , ] . pregnant women face special challenges because of their responsibilities in the workforce, as caregivers of children and other family members, and their requirements for regular contact with maternity services and clinical settings where risk of exposure to infection is higher. due to this reason, this study tried to assess the impacts of covid- infection on antenatal care services. the general objective of this study was to assess the impact of covid- infection on maternal and reproductive health care services among mothers getting service in governmental health institutions of dessie town, g.c. all rights reserved. no reuse allowed without permission. perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint institution based cross sectional study design using mixed (quantitative supplemented with qualitative) method was employed to identify the impact of covid- infection on maternal and reproductive health care services among women who get service in governmental health institutions of dessie town. the study was conducted from july - / . the source populations were all women who get maternal and reproductive health care services in governmental health institutions of dessie town. all women who get maternal and reproductive health care services in governmental health institutions of dessie town during the data collection period were taken as study population. the sample size in this study was determined by using single population proportion formula. since there was no any previous study conducted on the topic, the prevalence of covid- infection was taken as %. the required sample based on the usual formula was as follows: n= (zα/ ) . p ( -p) d where n = desired sample p = proportion of covid- infection on pregnant women to be . zα / = z value to % significance level= . d = margin of error ( . ) tolerated then, n = ( . ) *( . ) *( . ) = , from undefined population. ( . ) n = , adding % non-response rate, the final sample taken was ~ . study subjects were selected from each health institution by using systematic random sampling until the minimum calculated sample size is obtained. the number of subjects selected from different hospitals and/or health centers were determined proportionally. for qualitative part a total of homogeneous study subjects were selected purposely from each health institution (approximately interviewees from each health institution). for the quantitative part, pretested and semi-structured questionnaire was used to collect the data. the data was collected by using face to face interview technique from the mothers. questionnaires for each item were adopted from previously done similar studies and modified according to the objective of this study. for the qualitative part, face to face in depth interview was used. during interview, the responses were recorded and the interviewer has taken notes. from the very beginning, data collectors and supervisors have given a full course of training regarding the basic principles of data collection procedures for both quantitative and qualitative techniques. the data collection tool was pretested with % of the study subjects. the participants for the pretest were taken from kombolcha health center to prevent information contamination. the principal investigator and supervisors have made a day to day on site supervision during the whole period of data collection. at the end of each day, the questionnaires were reviewed and checked for completeness, accuracy and consistency by the supervisors and investigators and corrective discussion was undertaken with all the research team members. the questionnaire was checked for completeness and consistency and entered and edited in the computer for statistical analysis. data was entered in to epi data . . database. furthermore, the data editing and clearance was done on the same software. finally, the data was taken to spss version . for the final analysis. the findings of the study was summarized and presented using tables, descriptive measures and statistical diagrams. the findings from the qualitative part were presented by narration. the study was approved by the ethical review board of wollo university, research and community service vice president office and a cooperation letter was obtained from south wollo health office and each respective hospital administrative office. verbal consent was obtained from each study participants. the right of the respondents to refuse to answer for any or all questions was respected. names of the clients was not recorded in the questionnaires and strict confidentiality was assured through anonymous recording and coding of questionnaire and by placing them in safe place after they had been collected; and was used for the purpose of the study only. a total of participants were responded to all the questions making the response rate %. thirty seven percent of respondents were in the age group of - years. most of the respondents were married which accounts, ( % perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in the copyright holder for this this version posted september , . eighty two percent of respondents reported that they had got appropriate care while ( %) said that they did not get appropriate care after corona outbreak. concerning the reasons why they did not get appropriate care, more than three-fourth ( . %) of participants mentioned fear of health care providers. the majority, . % of respondents believed that covid- does not strengthen home delivery. more than one-third ( . %) of participants reported that their support people were not allowed them to attend delivery at health institutions. nearly one-third ( . %) of study participants believed that the support they got from health care providers was somewhat worsened. a total of one hundred fifty ( ) respondents gave birth at health institution during the data collection period. nearly half ( . %) of postnatal care attendees stayed at health facility greater than or equal to hours while significant number( . %) of participants were sent to home less than hours. shortage of health care providers was the most frequently ( . %) reported reason to send to home at less than hours followed by clients desire to go to home ( . %). more than half ( . %) of respondents reported that they were visited by health care providers every minute. among ( . %) of participants who said that they were monitored by health care providers less frequently (every minute or every hour), . % reported that health care providers were busy. half ( %) of postnatal care attendees said that covid- had no impact on their regular child care while more than one-fourth ( . %) of respondents had experienced difficulty of arranging their regular child care. three-fourth ( . %) of postnatal care attendees had changed their plan from formula feed to all rights reserved. no reuse allowed without permission. perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint fully breast feeding. more than half ( %) of study participants said that the care they got from health care providers was not changed while one-third ( . %) of them reported that the support they got from health care providers was somewhat worsened. nearly half ( . %) and . % of respondents were mildly and extremely stressed due to the change in their newborn plans respectively. forty two ( %) and . % of respondents were stressed due to their health concerns and social distancing respectively while . % cope their stress by watching television. (refer table ) a total of clients were asked regarding their reproductive health care service utilization after corona outbreak. more than half ( . %) of respondents had ever used contraceptives after corona outbreak. more than one-third ( . %) of the study participants did not ever used contraceptives due to unavailable service ( %), travel restrictions ( %) and no plan to use family planning( %). majority ( . %) of respondents did not experience abortion after corona outbreak while only . % of them had experienced it. from those who had all rights reserved. no reuse allowed without permission. perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint experienced abortion, more than half ( . %) of them did not go to health institutions since they think that the service may not be given as a result of corona. most of the respondents ( . %) did not experience unwanted pregnancy after covid outbreak. among those who had experienced unwanted pregnancy, more than half ( . %) of them were due to their thought that they can't get family planning service due to corona. (refer table ) for the qualitative part, participants were interviewed by face to face in depth interview. during interview, the responses were recorded and the interviewers have taken notes. the responses are summarized in sections. most study participants were stressed due to risk of corona transmission from health care providers while they provide care for them. they also described that they were stressed because they think that if they became infected with corona it may affect their fetus. perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in most of interviewees expressed that health care providers didn't frequently visit them due to shortage of health care providers. a -year-old woman said that '' i was in labor ward. my labor pain became worse and i was shouting and calling the doctor to see me, but no one treated me for at least hours after admission.'' some of the interviewees described that the care they got from health care providers didn't change due to corona; rather the care was improved a little bit. a -year-old woman described her experience as '' i was admitted in labor ward and the health care providers provided me special care better than usual; all of them wore masks &gloves and has washed their hands frequently.'' some interviewees reported that the postnatal care provided was significantly decreased. after delivery health care providers didn't visit frequently and sent clients to home at less than hours of hospital stay. a -year-old woman said that ''i had faced difficulty of breast feeding after birth and no one helped me to breast feed my neonate. i was also sent to home after hours of hospital stay.'' one of the health care services negatively affected by corona was reproductive health care as the concern of the health sector health force is shifted towards corona prevention. a -yearold divorced women reported that '' my sister has gone to health institution to get family all rights reserved. no reuse allowed without permission. perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in a -year-old lady also said that '' i fear to go to health institutions to get reproductive health care services because i think the health institutions is full of corona. rather we prefer to purchase drugs at pharmacies. i know a woman who has experienced abortion following unwanted pregnancy after corona outbreak, but she didn't go to health institution due to fear of contracting corona.'' all rights reserved. no reuse allowed without permission. perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint this study tried to assess the impact of covid- on maternal and reproductive health care services in governmental health institutions of dessie town. the result of this study was discussed with different findings all over the world. even though the majority of antenatal care attendees said that they got appropriate antenatal care, some respondents reported inappropriate care due to fear and shortage of health care providers which may strengthen home delivery. the finding of this study is in line with the finding in america which reported that an increasing number of health workers are being exposed, while midwifery services are overwhelmed by calls from concerned mothers now exploring home birth options. the problem of shortage of health care providers might be more profound in developing countries like ethiopia [ , ] . according to this study, three-fourth ( . %) of anc attendees agreed that covid- decreases anc visits. the finding of this study revealed that the most frequent reported impact of covid- on anc service were shifting of human resources to corona prevention ( . %) followed by cancellation of anc visits ( . %). similarly, covid- technical brief package for maternity services reported that deploying maternity care workers away from providing maternity care to work in public health or general medical areas during this pandemic is likely to increase poor maternal and newborn outcomes. ten percent ( %) decline in service coverage of essential pregnancy-related and newborn care ( , , additional women experiencing major obstetric complications without care) were reported from low-and middle-income countries. this similar finding could be justified that the impact of covid- is global [ , ] . in this study, eighteen percent ( %) of delivery care attendees reported that they didn't get appropriate care, of this . % of them said that the support they got from health care providers was worsened. the result is similar with the study conducted by ashish kc, rejina g and mary v which indicated that delivery care after the pandemic was decreased (health workers greeting the mother decreased by . % (- . to - . ), the use of gloves and gown for childbirth decreased by . % (- . to - . ), companionship during labour decreased by . % (- . to - . ), and intrapartum fetal heart rate monitoring decreased by . % (- . to - . ). this might be due to fear of health care providers to frequently make contacts with laboring mother and shortage of medical supplies such as gloves [ ] . this study revealed that nearly half ( . %) of postnatal care attendees reported that they stayed at health facility less than hours after delivery and the most frequently mentioned reason to stay at less than hours was clients desire to go home. this finding is similar with a study conducted in europe by kirstie c and cristina f which reported that women are sent home more quickly after a miscarriage or stillbirth, and accounts of bereavement rooms being re-allocated to the care of women who have covid- [ ] . the reason might be clients' attitude that staying more at health facility could increase risk of acquiring covid- , in this study, nearly half ( . % of respondents said that they were visited less frequently after delivery and the reason was that health care providers were busy which accounts . %). similar study conducted by kirstie c and cristina f in europe showed that maternity providers have often limited follow-ups, and as in other eu countries, some uk hospitals have stopped allowing birth partners to be present [ ] . the reason could be justified that maternity care providers are shifted to covid- prevention as well as shortage of necessary medical supplies to frequently visit clients. in our study, significant proportion of postnatal care attendees ( . %) reported that the support they received from health care providers was worsened. similarly the study in nepal reported decreased postnatal care (placing the baby skin-to-skin with the mother decreased from % to %, and breastfeeding within hour of birth decreased by . % (- · to - · ). the possible explanation could be health care providers may worry that skin to skin contact and breast feeding would transmit the virus to newborns. the study in nepal also showed that immediate newborn care practice of cord clamping min after birth increased slightly after the outbreak. this could be due to health care providers' assumption that immediate cord cut may reduce risk of transmission to the newborn [ ] . in this study, among women who were in need of contraceptives, nearly one-third ( %) of them didn't use contraceptives due to unavailability of the service. the result is in line with the study in america which reported that women were unable to access family planning and some of these women stopped going to facilities due to fear of infection and increased physical and financial barriers [ , ] . another study done by taylor riley, guttmacher, elizabeth sully et al also indicated that covid- pandemic is already having adverse effects on the supply chain for contraceptive commodities by disrupting the manufacture of key pharmaceutical components of contraceptive methods or the manufacture of the methods themselves (e.g., condoms), and by delaying transportation of contraceptive commodities. a report from low-and middleincome countries indicated that potential annual impacts of a % proportional decline in use of sexual and reproductive health care services resulting from covid- -related disruptions [ , , and ] . in this study, more than half ( . %) of respondents who has experienced abortion didn't go to health institutions since all ( %) of them think that the service may not be available during this corona period. this study also showed that, among those who have experienced unwanted pregnancy after corona outbreak, . % of them mentioned unavailability of family planning services as a reason for the occurrence of unwanted pregnancy. this is similar with the study done by taylor riley, guttmacher, elizabeth sully et al which reported that and providers are being forced to suspend some sexual and reproductive health services that are not classified as essential, such as abortion care, thus denying people this time-sensitive and potentially lifesaving service. ten percent ( %) shifts in abortions from safe to unsafe ( , , additional unsafe abortions) were reported from low-and middle-income countries [ , , and ]. in this study, a substantial decrease in institutional delivery was seen (in spontaneous vaginal delivery and instrumental delivery, . % and % respectively) while the number of women who gave birth by c/s was increased by % (from % to %). similar study conducted by ashish kc, rejina g and mary v revealed that a substantial decrease ( . %) in institutional delivery was seen between january and may, . the same study also revealed that the proportion of women who had caesarean section increased from . % (n= ) before lockdown to . % (n= ) during lockdown (p= · ). the reason might be due to that women came to heath institutions for delivery only if they faced complications otherwise they would give birth at home during this pandemic [ ] . the neonatal death in this study was increased from . % to . %. this finding is in line with the study done in nepal which reported that the institutional neonatal mortality rate increased from deaths per live births before lockdown to deaths per live births during the lockdown. this might be due to decreased quality and frequency of antenatal care visits as well as maternal stress due to covid- . the current study showed a decreased still birth from . % to . %. in contrast to this, the study in nepal revealed an increased in still births from to / total births. this might occur due to difference in sample population, study period as well as study design [ ] . in this study, the proportion of maternal complications was increased from . % to . % which was higher than the finding in nepal in which the proportion of women who had a complication was increased from . % (n= ) before lockdown to . % (n= ) during lockdown (p= · ). the difference might be justified that the quality of health care was better in nepal (the supply of medical equipment's that help to prevent covid- in ethiopia was low [ ] . this study concluded that covid- significantly affects the quality and utilization of maternal and reproductive health care services. according to edhs report, the utilization of maternal and reproductive health care services in ethiopia was low (institutional delivery- %, antenatal care coverage- % and contraceptive prevalence rate- %) and covid- could further decrease this coverage. according to this study, six percent ( %) of antenatal care attendees, % of delivery care attendees and nearly half ( . %) of postnatal care attendees reported inappropriate service delivery due to fear of health care providers, shortage medical supplies and staff work load. the study also showed that utilization of these services was decreased due to fear of clients to go to health institutions. significant number ( % of antenatal care attendees, . % of delivery care attendees and . % of postnatal care attendees reported that the support they received from the health care provider was worsened due to covid- . additionally, more than one -third ( . %) of antenatal care attendants reported cancellation of regular anc visits. the majority ( . %) of participants was stressed due to corona and health concern was the greatest source of stress which accounts %. most ( . %) of the respondents reported that covid- has negative impact on their life, of which nearly one-third ( . %) of them stated it as extremely negative impact. significant numbers of respondents have experienced unwanted pregnancy after corona outbreak. of these, . % of them mentioned unavailability of family planning services as a reason for the occurrence of unwanted pregnancy. the qualitative finding indicated that covid- has significant negative impact on maternal and reproductive health care services (stress, cancellation of anc visits, decreased quality and no desire to go to health institutions as clients think health institutions is risky place). the data collected from documents indicated that the number of clients who have used different maternal and reproductive health care services was significantly decreased. according to the findings of this study, the researchers would like to forward the following recommendations.  to ministry of health: ministry of health should  continue maternity services to be prioritized as an essential core health service, and other sexual and reproductive health care such as family planning, emergency contraception, treatment of sexually transmitted infections, and where legal safe abortion services, to the full extent of the law, also need to remain available as core health services.  provide full access of all personal protective equipment (ppe), sanitation and a safe and respectful working environment for maternity care providers  to health institutions: health institutions should  avail all necessary medical supplies (gloves, masks, sanitizer etc) for both health care providers and clients to improve quality of maternal and reproductive health care services.  assign adequate number of health care providers at each unit/ward.  provide health education for clients to avoid misunderstanding towards corona as respondents think going to health institution increases risk of acquiring it.  improve the quality of their services to attract clients  to wollo university: wollo university should  organize awareness creation program at community level to increase utilization of maternal and reproductive health care services.  to researchers  further study using strong study design with additional variables should be conducted in the future. royal college of obstetricians and gynecologists, coronavirus (covid- ) infection in pregnancy: information for healthcare professionals resources for pregnant people and their families national comprehensive covid management handbook: federal ministry of health-ethiopia covid- : what implications for sexual and reproductive health and rights globally? covid- ) preparedness and response -unfpa technical briefs v impact of covid- infection on pregnancy outcomes and the risk of maternal-to neonatal intra-partum transmission of covid- during natural birth covid- must catalyse key global natural experiments tackling covid- : can the african continent play the long game? more effective strategies are required to strengthen public awareness of covid- : evidence from google trends estimating the potential impact of covid- on mothers and newborns in low-and middle-income countries estimates of the potential impact of the covid- pandemic on sexual and reproductive health in low-and middle-income countries coronavirus disease (covid- ) and pregnancy: what obstetricians need to know infants born to mothers with a new coronavirus (covid- clinical manifestations and outcome of sars-cov- infection during pregnancy stay at home: guidance for households with possible coronavirus (covid- ) infection pregnant women with new coronavirus infection: a clinical characteristics and placental pathological analysis of three cases infants born to mothers with a new coronavirus (covid- clinical analysis of neonates born to mothers with ncov pneumonia potential maternal and infant outcomes from coronavirus -ncov (sars-cov- ) infecting pregnant women: lessons from sars, mers, and other human coronavirus infections nine things congress must do to safeguard sexual and reproductive health in the age of covid- the impact of the coronavirus (covid- ) pandemic on maternity care in europe covid- technical brief package for maternity services . estimates of the potential impact of the covid- pandemic on sexual and reproductive health in low-and middle-income countries effect of the covid- pandemic response on intrapartum care, stillbirth, and neonatal mortality outcomes in nepal: a prospective observational study the study was approved by the ethical review board of wollo university and a cooperation letter was obtained from each health institutions administrative office.written consent was obtained from each study participants. the right of the respondents to refuse to answer for any or all questions was respected.consent for publication: all authors fully agreed. the authors declared that there is no conflict of interest in this research article. please contact author for data requests. all cost related to this research was covered by wollo university research and community service coordinating office. the data collection was undertaken by all the authors. all the authors contributed in the data analysis, design and preparation of the manuscript. all authors read and approved the final manuscript and have all agreed to its submission for publication. first of all, we would like to express our sincere thanks to the almighty god for his love, forgiveness and generosity.it gives great pleasure to present our sincere thanks for the support we got from the administrative staffs of each governmental health institutions.our thanks also go to wollo university, research and community service coordinating office for allowing us to do this research work. key: cord- -bf lj f authors: jayasinghe, saroj title: social determinants of health inequalities: towards a theoretical perspective using systems science date: - - journal: int j equity health doi: . /s - - - sha: doc_id: cord_uid: bf lj f a systems approach offers a novel conceptualization to natural and social systems. in recent years, this has led to perceiving population health outcomes as an emergent property of a dynamic and open, complex adaptive system. the current paper explores these themes further and applies the principles of systems approach and complexity science (i.e. systems science) to conceptualize social determinants of health inequalities. the conceptualization can be done in two steps: viewing health inequalities from a systems approach and extending it to include complexity science. systems approach views health inequalities as patterns within the larger rubric of other facets of the human condition, such as educational outcomes and economic development. this anlysis requires more sophisticated models such as systems dynamic models. an extension of the approach is to view systems as complex adaptive systems, i.e. systems that are 'open' and adapt to the environment. they consist of dynamic adapting subsystems that exhibit non-linear interactions, while being 'open' to a similarly dynamic environment of interconnected systems. they exhibit emergent properties that cannot be estimated with precision by using the known interactions among its components (such as economic development, political freedom, health system, culture etc.). different combinations of the same bundle of factors or determinants give rise to similar patterns or outcomes (i.e. property of convergence), and minor variations in the initial condition could give rise to widely divergent outcomes. novel approaches using computer simulation models (e.g. agent-based models) would shed light on possible mechanisms as to how factors or determinants interact and lead to emergent patterns of health inequalities of populations. health outcomes are increasingly perceived from a systems approach that is more holistic and non-reductionist [ ] . the author in a recent paper extended the systems approach to incorporate principles of complexity science and to conceptualize population health outcomes as an emergent property of a dynamic and open, complex adaptive system [ ] . the current paper explores these themes further and applies the principles of systems approach and complexity science (i.e. systems science) to conceptualize social determinants of health inequalities (sdhi). the paper begins with a brief overview of the existing models of sdhi, and then proposes a two step approach to remodel our perspectives and outlines possible implications. interest in studying social influences of population health outcomes dates back to at least the th century. pioneering researchers in this area include rudolf virchow who reported on the role of political economy and poverty in causing an epidemic of plague in upper silesia of prussia, and friedrich engels on the link between high mortality and poor living conditions of the working class in england [ ] . subsequently salvador allende's work in chile attempted to show the role of social and political factors in generating health inequalities in populations [ ] . more recent expansion of a population-based approach to inequalities includes the work of geoffrey rose in the 's [ ] . he distinguished between causes of incidence of a population group and causes of disease in individuals. the extreme example he proposes was to assume that every member of society smoked cigarettes a day, which if investigates through cohort studies and case-control studies, will lead to the conclusion that incidence of lung cancer is determined by genetic predispositions. these smoking patterns are a reflection of social norms, values, traditions and their customs, in a historical context. thus, societies with lower per-capita rates of smoking have a significantly lower incidence of lung cancer. the balances or imbalances of norms and social structures within the population lead to distinct patterns of individual behaviours in smoking rates or varying rates of disease prevalence or incidence among social groups, i.e. inequalities. sick individuals represent the extremes of the population mean. recent literature uses the term social determinants of health inequalities (sdhi) to denote contexts, social norms, social structures, and their determinants. three main pathways have been advanced to explain the generation of health inequalities from the social environment [ ] . (a) "social selection", or social mobility which implies that health determines socioeconomic position, rather than the reverse. thus, healthier persons will move towards better socioeconomic positions, compared to less healthier, leading to inequalities. (b)"social causation" proposes that a range of unequally spread material, psycho-social and behavioural factors, give rise to inequalities in health outcomes [ , ] . material factors include varying income levels and investments across infrastructure beneficial to the community. psychosocial factors are the chronic stresses that arise from perceptions and experiences of personal status in an unequal society. behavioral factors are, for example, the higher rates of smoking observed in poorer groups that lead to differential rates of diseases and mortality [ , ] . (c) a "life course perspective" suggests that a multitude of factors across the life span (e.g. maternal malnutrition during fetal period, poor educational facilities in childhood, occupations with physical hazards etc.) determine and manifest disease trends observed over time. the ecosocial approach attempts to integrate these ecological, social and biological factors in disease causation through a dynamic process of their 'embodiment' i.e. "we literally incorporate biological influences from the material and social world" [ , ] . there are several biological pathways that explain how social environment gets 'embodied' on health. one is the 'stress biology approach' whereby stress leads to chronic stimulation of the hypothalamo-pituitaryadrenal axis and the resultant hormonal changes increase risks of hypertension, insulin resistance, and hyperglycaemia [ ] . the other relates to the advancing field of epigenetics, i.e. non-genetic modifiers of gene expression that are transmitted to future generation. they provide an explanation as to how environmental effects convert to lasting physiological changes and behavioral changes. an example is how psychological stress alters dna methylation and histones in stress-sensitive brain regions such as the hippocampus, amygdala, and prefrontal cortex. these changes modulate subsequent gene expression [ ] . another pathway is through modifications of telomeres in dividing somatic cells. telomeres are dna repeat sequences, which together with accompanying telomere-binding proteins, cap and protect chromosome ends. their length shortens with each cycle of replication, which is an expression of accelerated ageing as this process ultimately leads to a loss of capacity to replicate. it has been shown that lower socio-economic groups demonstrate shortening of the length of telomeres, thus suggesting that these groups acquire features of accelerated ageing with its consequences [ , ] . the commission of sdh (csdh) re-conceptualizes health inequalities by integrating these theories and concepts further [ , ] . they describe sdhi to have a context, structural mechanisms and socioeconomic positions of individuals. it assumes a crucial role for the "context" which includes social systems (e.g. education system, labour market), culture (e.g. racism and caste) and political systems (e.g. structure of the state, redistributive policies). the structure of the state in relation to welfare and redistribution of wealth is recognized as a dominant institution. the 'context' should be viewed as a dynamic concept, having a historical past, a present and future trajectory. structural mechanisms that are rooted in institutions and processes within the context generate stratifications in society according to socio-economic position, income or wealth, educational achievements and access, occupation, gender, race/ethnicity and other dimensions. these are inter-related dimensions and could act as proxies for each other. for example, in a heavily market-driven individualized society, incomes or wealth are good proxy indicators for socio-economic position. the socioeconomic position in turn is a key stratifier in most contemporary societies and reflects a hierachical system consisting of power, prestige and access to resources. the sdhi operate through a group of intermediary determinants to mould health outcomes. the main groups of intermediary determinants of health are: material circumstances (e.g. quality of housing, exposure to pollution, financial means to purchase quality food, and work environment); psychosocial circumstances (e.g. levels of stress and social support); behavioural factors (e.g. rates of tobacco and alcohol consumption, nutrition and physical activity) biological factors (e.g. genetic predisposition to diseases in different population groups) factors) and the health system (e.g. access to quality care in populations). increasingly, research evidence reports a widening range of influencing material circumstance (such as availability of safe water and sanitation, agricultural policies and food security, access to health and social care services, unemployment, under-employment and working conditions, access to housing, the living environment, access to education, and availability of transport) [ , ] . those holding higher positions in the hierarchies of social stratification (e.g. higher socio-economic position or most affluent) would hold an advantageous position in accessing resources, information and environments that are more favourable to better health outcomes. an implicit and explicit recognition of an inter-related web of factors functioning as a system runs through the above discourse. rose's concept of causes of incidence in a population group, implies that the population functions as a cohesive 'whole' or system, rather than being a mere collection of independent individuals. similarly, the concept of sdhi proposed by the csdh describes a system that consists of elements such as, a context, structural mechanisms, and intermediary determinants. these are related both as influencers as well as through feedback mechanisms. however, as with most concepts related to health outcome, sdhi implicitly and explicitly accepts certain elements of a newtonian view of reality (i.e. reductionism, linearity and hierarchy) [ , ] . an example of this reductionist approach is the descriptions of a single factor that influences health outcomes (e.g. socio-economic stratification of mortality due to asthma) and selecting interventions that focus on a single determinant (e.g. improving thermal comfort in houses that have inadequate warmth) [ ] . another assumption prevalent in this discourse is linearity, which assumes that determinants of inequalities can be applied across a wide range of contexts. for example, differential access to healthcare or education is explicitly or implicitly assumed to lead to variations in outcomes, almost in a linear fashion [ , , ] . this view does not give adequate credit to unintended consequences commonly seen in reality. for example, mobile phones have improved connectivity, but their use while driving have become an important cause of road traffic accidents, a feature that was never predicted at the outset. another key concept is the role of hierarchies or power, position and access to resources (e.g. in the understanding of socio-economic position). the concept of hierarchies is implicitly used to explain the process of sdhi as exemplified by terms such as proximate or distal determinants of health inequalities. this indicates a clear path of influences that arise 'distal' to the population group (e.g. labour laws that determine wage structure) and affect it through more 'proximal' factors that are closer to the population (e.g. income) [ , ] . the statistical methods of estimating the effects of determinants also imply other features of the mechanistic reductionist paradigm. earlier generation of studies used relatively simple statistical models such as odds ratios [ ] . these methods assume that explanatory variables have a cause and-effect-pathway (i.e. unidirectional path of influences) and do not encompass positive or negative feed-back loops between the outcome variable and explanatory variables. for example, poor education leads to higher probability of ill-health, which combined together lowers the level of employment and ability to generate income, which in turn influences the ability to live in a more affluent neighbourhood and therefore reduces opportunities for further education, and higher grades of occupations, as well has increases exposure to more polluting environments. they also ignore interrelations among individuals. for example health education could have a positive health impact on an individual, that could indirectly improve the health of the individual's friends. more sophisticated statistical methods, e.g. generalized linear models such as multiple regression, logistic regression and poisson regression, account for multiple explanatory variables and to those that are not normally distributed. however, these analyses do not include feedback loops and interrelations among individuals. the latter require multilevel or hierarchical regressions models [ ] . they 'implicitly assume that these effects can be isolated from each other and do not allow for feedback loops or reciprocal interactions between groups and individuals, or between outcomes and predictors' [ , ] . systems science combines systems theory and complexity science. systems theory states that properties of a complete system cannot be predicted by disaggregating, analyzing and exploring its individual constituent parts alone [ ] . complexity applies systems theory to open and adaptive systems (i.e. complex adaptive systems) and views health outcomes as an emergent property of such systems [ , ] . the next sections propose a two-step process to visualize sdhi from a systems science perspective, firstly, by shifting away from a reductionist paradigm towards a systems approach and secondly, by enriching this with principles of complexity science. in applying the systems approach, a point of departure from the conventional model of thinking is to consider population health outcomes as one of many components of the human condition or the 'standard of living' of a population. this human condition has several other facets or components such as educational attainment, economic well-being, and social status. these components too exhibit patterns of inequalities, in a manner similar to health outcomes. health inequalities should be viewed as patterns in health outcomes that arise in association with other patterns of human condition, and lie within this milieu. extricating health outcomes from these other human conditions and exploring it individually is therefore arbitrary, though justified on grounds of interest, existing disciplinarity and convenience of tackling one component at a time sdhi can be visualized from a systems approach using a matrix that captures at least part of the elements of the human condition system. each group of columns will represent a facet of the human condition (e.g. health outcomes, educational attainment). for comparison between countries, the parameters should be uniform and preferably continuous variables. the bundle of parameters in health outcomes could include life expectancy at birth (leb), vaccination rate of children at years, inverse of infant mortality rate (imr), inverse of maternal mortality rates (mmr), and inverse of childhood malnutrition rates. similarly, the parameter bundle on educational attainment could be percentage enrolment by years, percentage in secondary level education, and per-capita investment in education, and for socio-economic status, the per-capita income, and employment rates. each row could be for a particular year or for specific intervals (e.g. to ). an appropriate colour coding for the parameters will give rise to a pattern in the matrix that will be a fingerprint of the human condition of a particular country. the whole matrix represents the totality of the human condition as an output. a similar method of visualization is used to illustrate worldwide trends in life expectancy at birth from to published in the human development report [ ] . this process will also demonstrate the disadvantages of narrowing our perspective to a particular health outcome (e.g. obesity rates) or its determinants (e.g. physical activity). when such single parameters are selected from the matrix, we are in reality focusing on a single facet of health outcomes extracted from a column of the matrix. instead, the preferred option is to express data on several other health related outputs such as imr, mmr, leb, and morbidity rates. this will immediately highlight unintended consequences, a feature of complex adaptive systems. once a predetermined bundle of health outcomes are used to describe health, e.g. leb, imr, and mmr, comparisons between countries or regions become easier. the second step is to incorporate an inequalities dimension to this form of visualization. this could be done on standardized measures of inequalities or stratifiers (e.g. across income or wealth or educational attainment, or geographic region) over a period or - years (see fig. ). this will allow tracking of trends within a country. for example, a stratifier such as income could impact across several categories of the human condition. this impact could be visualized using the following summary measure of inequalities: a) health inequalities: odds ratios between highest and lowest income quintile in parameters such as imr, mmr, under- year vaccination rates, childhood nutrition, leb b) educational attainment: odds ratios between highest and lowest income quintiles in education such as primary school enrollment, secondary school enrollment, and tertiary education. c) inequalities in social capital: odds ratios between highest and lowest income quintiles in measures of social capital, contact with social networks, one option is for individual countries to have several of these charts, one for each stratifier, and track selected measures of inequalities (e.g. ratios of imr, leb, mmr, primary school enrollment) over a period (e.g. every years). each cell will be filled by the result of the odds ratio. in order to give an immediate visual impression, a simple set of rules could be observed to colour the cells in the matrix. the colour coding could be such that the cells showing extreme values of a ratio (e.g. above an odds ration of ) and having the widest the inequalities will receive red colour and the least receive green, with other intermediates receiving light green, yellow, and orange. the precise values at which the colour transits would be arbitrary (e.g. one may choose a ratio of and above to be red and below . to be green) see fig. . however, it is necessary to be consistent in order to allow for comparisons along the time axis and between countries or regions. a series of matrices developed for each stratifer in a country, could be analysed subsequently using hierarchical clustering algorithms (e.g. hierarchical clustering and k-means clustering) and computational methods (e.g. organizing maps and artificial neural networks) [ ] . hierarchical clustering will produce a 'tree' of those cells that are closest to each other (e.g. those with closest values as percentages). heat maps can also be used to illustrate the clustering and it increasingly used to describe multimorbidity [ ] . such analyses from individual countries and the emerging patterns of health outcomes will give invaluable insight on the processes that are involved in giving rise to these particular patterns. it is possible that this method will demonstrate clusters of inequality measures that would not be expected from usual epidemiological parameters. an analogous situation was seen with data from acutely ill patients in intensive care units, where by clusters of physiological parameters were observed that could not be defined by conventional knowledge [ ] . the third step is to view the system as a dynamic entity and to include dynamic dimension to the approach. describing outcomes at a given time is a mere snapshot of a dynamic process and analogous to prognostication of diabetes and its risks by using a single random blood glucose level. extending this further, the predictions become more robust if a series of observations are made and this dynamism is incorporated into the model by using rates of change of parameters (e.g. rate of decline of imr). parallels are seen in systems medicine where serial analyses of the pulsatile secretion of insulin (rather than fasting insulin) was found to be an early feature of diabetes rather than a single value [ ] . data can now be gathered relatively inexpensively using crowd-sourcing techniques (i.e. gathering information by engaging with a large number of people usually via the internet) and real-time surveillance of information in twitter and other social media [ , ] . a systems approach views the human condition and their determinants as causes as well as outcomes. they are interlinked in a causal web, rather than a linear path of social determinants leading to a range of health outcome. the feedback loops lead to outcomes influencing their causations. for example, low income and deprivation lead to poorer health outcomes, which in turn makes the group even poorer and worsening health outcomes. in order to operationalize the above, more sophisticated models such as systems dynamic models are required [ ] [ ] [ ] . analogous models are now being developed for specific disorders such as obesity [ ] . a systems approach to sdhi emphasizes the role of the context in determining health inequalities. the relationships between the variations in health outcomes and other parameters would be more or less unique to that particular system. the interpretation of the outputs is heavily dependent on the context and less generalizable across different nations, social groups, or environments. this is yet another reason to explore natural experiments to identify causal pathways and interventions for a given context [ ] . the next advance is to incorporate complexity science to the systems perspective. this will require perceiving the patterns of human condition in a given population group to be an emergent property of a complex adaptive system (cas). the latter is a special type of system that is 'open' to its environment, with non-linear interactions among a dynamic set of other interconnected systems and subsystems. other systems include the political system (e.g. the predominant political governance system), the physical environment (e.g. pollution levels or transport), and biological systems (e.g. genetic predispositions), within the context of a larger social system [ ] . one could position this within the context of global ecosystems (e.g. the biosphere, the atmosphere, the hydrosphere, geosphere and cryosphere). a feature of a cas is that it has emergent properties, i.e. it is almost impossible to predict precisely what it the larger system will evolve to, by using knowledge relating to the interactions among its components and sub-components [ ] . rather than mathematical modeling where equations are the basis of the model, some complexity scientists use simulations using computer-based programmes (e.g. python) [ ] . the building blocks of these simulation models are considered to be as fundamental and irreducible as mathematic equations, and are being hailed as a 'new kind of science' [ ] . if the analogy of the matrix of sdhi used in the previous section is applied, the picture will be one of continuously changing colours and patterns that are not predictable. complexity scientists would mimic these patterns through computer simulations using simple rules that describe the inter-relationships among parameters. of the commonly used computer simulations, those most likely to mimic patterns of health outcomes seen in the matrix model are agent-based models, cellular automata, and networks. initial work on agent-based models by schelling showed that segregation in a city (often attributed to racial discrimination) can be simulated by simple rules applied to a grid where each cell represents a house [ ] . consider an example where % percent of houses are occupied randomly, either by blue or red, in approximately equal proportions. a programme will simulate future scenarios if they follow two simple rules: place each house where at least of encircling them are of similar colour as the house, and avoid the cell if they have one or none of same colour. within a few iterations, the emerging model begins to mimic cities that are segregated by race, poverty, or social status. these simulations provide evidence (but no proof ) that several alternate pathways could potentially explain urban clusters of race or poverty, rather than discrimination. extrapolating to health outcomes, they challenge area-wise aggregation of health outcomes are through pathway such as the neighbourhood effects or the effects of urbanization on health outcomes [ ] . cellular automata is another simulation where the programme places lines of square cells next to each other (e.g. you fill the cell with a black cell, if two of the eight cells around the cell of interest are black) as in a checker board [ , ] . the interesting observations include the following: minor changes in the rules and initial conditions lead to emergence of widely divergent patterns, some lead to recurring patterns, and similar patterns arise with different starting points and different set of rules. if this metaphor is applied to sdhi, it illustrates the uniqueness of the context to a particular pattern of health outcomes in a population, and the theoretical possibility that widely divergent determinants lead to similar patterns of outcomes in different situations. networks perceive systems as interlinked webs. the strengths and numbers of links among nodes can be varied to generate emergent properties mimicking reality. milgram pioneered the concept of small world networks, in which the degrees of separation between two individual members is considerably small compared to the given population [ ] . this was illustrated by an experiment that showed an average six intermediate acquaintances separate any two people on the planet. thus a highly infectious disease could theoretically spread to all billion on the globe in about six incubation periods! another improvement of this simulation is to incorporate the highly connected super-spreaders who are disproportionately relevant to rapid spread of the disease, called scale-free networks [ ] . in this model, new members of the network connect preferentially to those who already have a large number of contacts (i.e. analogous to individuals befriending the most popular members of a network). the resulting number of contacts per individual takes a power-law distribution. the recent epidemic of severe acute respiratory syndrome (sars) was such an example where a significant proportion of the infections were due to 'super-spreaders' [ ] . these networks resemble patterns observed in the spread of information along social networks and obesity in geographic areas giving rise to amazing patterns of spread [ ] . characterizing outcomes of the human condition (including health inequalities) as patterns that emerge in a complex adaptive system has several implications. firstly, isolating health outcomes from the other human conditions are problematic because they are features or dimensions of a larger picture and therefore more sophisticated forms of systems analyses will be required to shed light on sdhi. secondly, emerging patterns of a complex adaptive system cannot be estimated with precision by using the known interactions among its components (such as economic development, political freedom, health system, culture etc.). different combinations of the same bundle of factors or determinants can give rise to similar patterns or outcomes (i.e. property of convergence), and minor variations in the initial condition could give rise to widely divergent outcomes. this questions the ability to generalize with precision, the determinants of health outcomes from one contextual environment to another. thus the favoured models would be those developed for the particular context using longitudinal data and using systems dynamics of feedback and interrelationships. finally, computer simulation models (e.g. agent-based models) would shed light on possible mechanisms as to how factors or determinants interact and lead to emergent patterns of health outcomes of populations. the metaphor needs to shift from the current visualizations of health outcomes as rigid bar diagrams 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dynamics of the etiological agent of sars in hong kong: impact of public health interventions submit your next manuscript to biomed central and take full advantage of: • convenient online submission • thorough peer review • no space constraints or color figure charges • immediate publication on acceptance • inclusion in pubmed, cas, scopus and google scholar • research which is freely available for redistribution the author has no financial or non-financial competing interests (political, personal, religious, ideological, academic, intellectual, commercial or any other) to declare in relation to this manuscript. the author is responsible for conceptualising the issues in the article and writing the manuscript. the author qualified with a mbbs (hons) from university of colombo, and was awarded md (colombo), frcp (london) and md (bristol). he is an academic in the university of colombo, sri lanka, and a practicing physician at the national hospital of sri lanka, colombo. he has a special interest in social determinants of health, poverty, health equity, and the application of complexity science to health. key: cord- -zz w ro authors: beermann, sandra; allerberger, franz; wirtz, angela; burger, reinhard; hamouda, osamah title: public health microbiology in germany: years of national reference centers and consultant laboratories date: - - journal: int j med microbiol doi: . /j.ijmm. . . sha: doc_id: cord_uid: zz w ro in , in agreement with the german federal ministry of health, the robert koch institute established a public health microbiology system consisting of national reference centers (nrcs) and consultant laboratories (cls). the goal was to improve the efficiency of infection protection by advising the authorities on possible measures and to supplement infectious disease surveillance by monitoring selected pathogens that have high public health relevance. currently, there are nrcs and cls, each appointed for three years. in , an additional system of national networks of nrcs and cls was set up in order to enhance effectiveness and cooperation within the national reference laboratory system. the aim of these networks was to advance exchange in diagnostic methods and prevention concepts among reference laboratories and to develop geographic coverage of services. in the last two decades, the german public health laboratory reference system coped with all major infectious disease challenges. the european union and the european centre for disease prevention and control (ecdc) are considering implementing a european public health microbiology reference laboratory system. the german reference laboratory system should be well prepared to participate actively in this upcoming endeavor. public health microbiology laboratories play a central role in detecting infectious disease, monitoring outbreak response and providing scientific evidence to prevent and control disease. they have important roles and responsibilities associated with accurate diagnosis, resistance testing and prevention of the spread of infectious disease. for example, outbreak investigations often depend on confirming cases by methods that are not commonly available in a routine laboratory setting. the scientific community, policy makers and pharmaceutical companies rely on advice and information from reference laboratories in order to adjust vaccine and antibiotic production (witze et al., ) . according to the european centre for disease prevention and control (ecdc), the five key activities of public health microbiology reference laboratories are reference diagnostics; reference material resources; scientific advice; collaboration and research; and monitoring, alerting and responding (european centre for disease prevention and control, ) . in the various european countries, microbiology reference laboratories are defined, organized, maintained and operated differently. we present an overview of germany's public health reference laboratory system. germany is a highly industrialized country with million inhabitants, and is made up of federal states ("länder"). the principal responsibility for public health lies with the states, or with their ministries of health, and with the almost local public health departments. since the s, the federal government ("bundesregierung"), federal assembly ("bundestag") and federal council ("bundesrat") have increasingly taken responsibility for healthcare reform and legislation. specific health issues, such as infectious diseases that threaten public safety and life cycle management of pharmaceuticals, are within the jurisdiction of the federal government. for example, the german protection against http://dx.doi.org/ . /j.ijmm. . . - /© elsevier gmbh. all rights reserved. infection act ("infektionsschutzgesetz," ifsg) as a federal law regulates the prevention and management of infectious diseases in humans. federated states are responsible for all primary aspects of public health, but there are also responsible for the implementation of federal laws, including federal social and labour laws. the robert koch institute (rki) is a federal institute within the portfolio of the federal ministry of health (bundesministerium für gesundheit, bmg). as such the rki is the central federal reference institution in the public health sector responsible for disease monitoring, control and prevention and conducting applied and response-oriented research in the field of disease control and prevention at the federal level. the research activities of the rki are partly directly related to the activity fields of a ministry. although robert koch and his contemporaries built a strong tradition for infectious disease epidemiology in germany in the late th and early th centuries, this tradition had all but disappeared in the s and s (allerberger, ) . in former west germany, the work of the rki as part of the then federal health office (bundesgesundheitsamt, bga) mainly focused on basic science research. the aids epidemic demanded a national public health response which resulted in the creation of the national aids centre in . in , when the bga was dissolved and the rki was assigned additional spheres of competence a combined aids center and infectious disease epidemiology division was created at the rki. in , representatives of the rki, the federal ministry of health and the federal ministry for education and research developed the concept of a network of collaborators whose goal was to intensify epidemiological research and improve infectious disease surveillance (fock et al., ) . as part of this concept, the rki implemented a weekly epidemiological bulletin, formed the committee for infectious disease epidemiology, trained epidemiologists for surveillance and outbreak investigation and set up a system of national reference laboratories: national reference centers (nrcs) and consultant laboratories (cls) (petersen et al., ) . they were responsible for laboratory surveillance of important pathogens and syndromes. these laboratories are considered national centers of excellence in the field of laboratory science for a particular pathogen or group of pathogens. nrcs establish and use reference methods, and can validate and verify test results from other laboratories (confirmatory testing). nrcs also produce and distribute reference materials for external quality control and assurance. owing to the high level of expertise, resources and infrastructure, nrcs and cls are involved in training and in providing expert advice to national health authorities and other laboratories. moreover, these laboratory scientists work closely together with their epidemiologist counterparts at the rki as well as those at the federal, state and local levels. the nrcs focus on outbreak detection and response and advice the rki in the preparation of case definitions according to the protection against infection act (ifsg). furthermore, the reference laboratories conduct or are involved in laboratory surveillance systems which provide additional information complementing statutory notifications. nrcs and cls are also involved in developing rki guidelines for physicians ("ratgeber für Ärzte") as well as investigating outbreaks and conducting epidemiological studies. the following are the basic tasks of nrcs and cls, which include detailed requirements referring to specific pathogens or syndromes as listed in the respective calls for tenders: general catalogue of nrc tasks ( ) developing or improving diagnostic procedures; coordinating standardization and distribution of generally accepted test procedures; initiating investigations for quality assurance. ( ) diagnosing and subtyping pathogens beyond routine measures, including molecular biological studies to elucidate the epidemiological context. ( ) maintaining a strain collection and distributing reference strains or diagnoses of specific reference strains, with the exception of commercially available isolates, such as from the american type culture collection (atcc) and the german collection of microorganisms and cell cultures (dsmz). ( ) organizing and coordinating the upkeep of a network of diagnostic facilities. ( ) providing a consulting service for public health services laboratories, practicing physicians, hospitals and research institutes; implementing continuing education and handling public relations. ( ) collaborating with reference laboratories of other countries as well as collaborating centers of the who, including participating in international ring trials. ( ) evaluating and interpreting data in coordination with the rki with the aim of best describing the epidemiological situation relevant for germany; initiating and participating in surveillance projects. ( ) monitoring incoming data with the goal of timely detection of outbreaks or outbreak hazards as well as immediate communication with the rki; support of public health services and the rki with complementary studies during outbreak investigations. ( ) epidemiological analysis and evaluating the development of resistance and virulence. ( ) reporting routinely to and consulting with the rki on relevant issues; participating in developing rki recommendations for diagnostics, therapies and prevention as well as for applied epidemiology of infectious diseases in general. general catalogue of cl tasks . consulting (especially with the public health services as well as laboratories, practicing physicians, hospitals and research institutes). . working within the framework of quality assurance (participating in studies and inter-laboratory tests, e.g., in cooperation with instand (german eqas), who, eu, and professional associations and participating in further education). . improving or developing diagnostic procedures. . participating in epidemiological evaluations of the current situation by the rki. . carrying out studies within the network of diagnostic facilities. . consulting with the rki in developing scientific materials concerned with pathogens or symptoms (e.g., case definitions, rki guidelines for physicians). the number of nrcs increased from in to in . presently, nrcs have been appointed (table ) . five laboratories are situated at the rki; the others are located at various universities and research facilities in germany. since , cls have decreased to designated cls, mainly devoted to providing scientific advice (table ) . currently a total of nrcs and cls located at universities, federal or state institutes and private laboratories are supported for this function by the rki. the high relevance of nrc and cl work for the surveillance of infectious diseases is evident by the wide range of national and international publications. for example, the nrc for mycobacteria and the rki performed analyses of routine laboratory diagnosis data of pediatric tuberculosis in the european union/european economic area (sanchini et al., ) . the nrc for helicobacter pylori and the rki examined h. pylori resistance to antibiotics in europe and its relationship to antibiotic consumption (megraud et al., ) . another example is the work of the streptococci nrc, which studied the epidemiology of streptococcus pneumoniae serogroup isolates from invasive pneumococcal disease in children and adults in germany (van der linden et al., ) . nrcs and cls are also involved in outbreak investigations and epidemiological studies. for instance, the cl for coronaviruses performed contact investigation for an imported case of middle east respiratory syndrome (reuss et al., ) , and the influenza nrc was involved in detecting local influenza outbreaks (schweiger and buda, ) . the rki and the nrc for surveillance of nosocomial infections examined the question, "how many outbreaks of nosocomial infections occur in german neonatal intensive care units annually?" (schwab et al., ) . additionally, the cl for legionella was involved in examining a legionnaires' disease outbreak associated with a cruise liner in august (beyrer et al., ) . dengue virus infections in a traveler returning from croatia to germany were analyzed by the nrc for tropical infection agents (schmidt-chanasit et al., ) . the nrc and the rki for meningococcal diseases and h. influenzae examined a cluster of invasive meningococcal disease in young men who have sex with men in berlin (marcus et al., ) . nrcs and cls are also involved in evaluating implemented vaccination recommendations and analyzing the effectiveness of the vaccines (kalies et al., ; ruckinger et al., ). for which pathogen a reference laboratory is to be established is decided based on the public health relevance of the pathogen as appraised by the rki and on the needs expressed by the national public health services ("Öffentlicher gesundheitsdienst," Ögd) . in addition, medical professional societies, the federal ministry of health and other third parties can approach the rki with perceived needs for additional reference laboratories. in the next step, the advisory board for public health microbiology (formerly called the committee for infectious disease epidemiology) assesses the proposal and provides the rki with a recommendation on whether to set up a new laboratory. in addition to the epidemiological relevance, and a declared need from national public health services, the availability of financial resources is another essential criterion. the decision to establish or continue an nrc or a cl is made by the rki, which considers recommendations given by the advisory board for public health microbiology, and must be confirmed by the federal ministry of health. appointments are restricted to three-year periods. the advisory board consists of up to experts, appointed by the rki for periods of three years. the members of this advisory forum are renowned experts in the fields of microbiology, virology, hygiene, epidemiology and public health. occasionally, other national and international professional societies and experts are consulted to achieve a solid appraisal of the candidate laboratories. from to , numerous important modifications were made to improve the transparency of the tendering and selection processes for the nrcs and the cls. a strict prioritization process, based upon necessity and not upon offer, was implemented. the evaluation process became more rigorous. essential evaluation criteria are public health needs and public health relevance, successful network activities, attestable quality assurance, publications as well as a positive appraisal of the advancement of diagnostic procedures. at the end of each appointment period, an evaluation of the laboratories is performed by the rki in cooperation with the advisory board for public health microbiology, which again consults national and international professional societies and experts. based on the evaluation results, the president of the rki, in cooperation with the federal ministry of health, appoints and reappoints the nrcs and cls. the evaluation of the cls resulted in the reappointment of cls and the shutdown of nine cls. reasons for closing were, for example, the retirement of the laboratory head (appointments are based on the combination of personal and institutional expertise), decreased public health relevance of the pathogen or an overlapping of the functional areas of responsibility with other cls or nrcs. in the evaluation of the nrcs, all nrcs were reappointed. in , the nrcs were supported with d , in total. in , the available funding increased to d , . the nrcs received between d , and d , per year. the decision on the level of funding of individual nrcs is made by the rki, based on criteria such as high consultation effort, high sample appearance and extraordinary public health relevance of the pathogen. in contrast to the nrcs, which have always been financially supported, the cls initially performed their work (mainly consultation) without any financial support. from april to december , the cls received basic funding of d per year (total amount in : d , ). in , the available funding increased to d , . the increase in funding was used to upgrade the cls' basic funding to around d , per year. beyond that, the funds had to cover new national networks. in , the nrcs received between d , and d , per year. thirty-three of the cls get d , , and seven cls with a high number of samples and extraordinary public health relevance of the pathogen received d , per year. the network projects were funded with approximately d , in . the nrcs have a more comprehensive work package than the cls and therefore the nrc receive a higher funding. public funding does not and cannot cover the total costs of the reference laboratories. since , the sphere of action and the workload of the laboratories have increased due to advancement of methods. at the same time costs in general have increased, but the grant total has remained unchanged. currently, funding increases for individual laboratories can occur only through money shifting from one laboratory to another or through giving up funding for existing nrcs or cls. in order to maintain the current quality and scope an increase in funding for nrcs and cls is urgently needed. since , the rki, in close cooperation with the advisory board for public health microbiology, has worked to foster collaboration between and among the nrcs and the cls. this concept was amended in a workshop with representatives of public health microbiology laboratories of other eu member states in . ten nrc networks were launched at a work conference of the standing working group of nrcs and cls ("ständige arbeitsgruppe nrz/kl") in stuttgart in . these networks covered the following topics: respiratory tract infections; enteral infections; infections in patients with immune deficiency or pregnancy; invasive bacterial infections; zoonoses; mycoses; sexual and blood transmitted infections; infections of the nervous system; antimicrobial resistance; and parasitoses, tropical and vector-borne infections. the aim of these networks was to facilitate the exchange of diagnostic methods among the nrcs and cls, to improve collaboration in planning and performing studies and to enlarge the geographic coverage of these services. furthermore, these networks should provide opportunities to work on issues beyond single pathogens. scientific coordination and administration are supervised by the rki. the advisory board for public health microbiology and external experts play a pivotal role in selecting the proposed network projects. essential selection criteria are public health relevance and the scientific quality of the proposal, the prospect of success and the cost efficiency of the planned network project. moreover, it is important that these projects contribute to expanding the network's characteristics. an exclusion criterion is if the project addresses established nrc or cl tasks. in , the network projects were funded with d , per year, allocated to ten projects (duration . years). as of , network projects ran for three years. in the funding period - , the rki supported eight projects. within the scope of the projects, common database infrastructures were set up, such as tissue material and serums. other projects performed cross-sectional studies to ascertain data on the prevalence and incidence of different pathogens. in , the rki evaluated the present composition and structure of the networks. the evaluations revealed that difficulties with ethical approval and with compliance with data protection and juridical aspects were the most commonly experienced hurdles during the study planning process. recruiting participating laboratories was also a challenge for some projects. it became clear that early involvement of epidemiological and statistical experts is necessary to further optimize study design and case number planning for the specific research questions and to raise the prospects of success for the projects. in addition to this evaluation, the rki organized a network meeting in , in which all nrcs and cls were represented. members of the advisory board for public health microbiology and representatives of the federal ministry of health participated. at this meeting, the networks shared their experiences. potential for improvement from the perspective of the members of the nrcs and cls as well as from the rki and the advisory board for public health microbiology was identified and discussed. as a consequence of this meeting, the rki initiated the following changes: ( ) regular network meetings with all nrcs and cls to address the stated need for regular face-to-face meetings, the rki will organize network meetings every three years. the meetings will take place one year before the start of the upcoming funding period for network projects, so that the nrcs, the cls and the rki can elaborate on the content and structure of project submissions. ( ) basic funding for the networks the rki will provide annual basic funding to allow for separate meetings of the respective networks, to facilitate exchange among network participants regardless of successful project applications. these meetings can be used for more intensive preparation of new project proposals and should strengthen network cohesion. ( ) stronger presence of the networks on the internet to satisfy network demand for the presentation of network projects to a larger professional audience, accepted projects will be presented on the rki's internet site. ( ) decrease in the number of funded projects in the past, the rki funded up to eight projects; in , the institute decided to decrease the number of projects funded per period in the future. in the current funding period four projects were selected for funding. in the following period only two projects will be financed. that implies higher financial support for single projects, which could be used to employ a study coordinator. ( ) two-stage application procedure for network projects the rki installed a two-stage application procedure for network projects. as the first step, the networks formulate short pre-applications. the rki screens these short concepts for network projects with the help of the advisory board for public health microbiology and external experts. in the case of positive assessment, the networks are asked to submit a detailed project proposal for final evaluation. during the last years, the field of public health microbiology has seen many changes. the everyday work of local public health agencies depends on the professional expertise of national reference centers (nrcs) and consultant laboratories (cls). meanwhile, the public often sees the relevance of public health microbiology only within the context of serious health events. during periods of restricted financial resources, the need for public health infrastructures is consistently questioned. the large ehec o outbreak in hamburg during provides an example of the importance of public health laboratory infrastructures (frank et al., ) . during the hamburg outbreak caused by fenugreek sprouts, the german public health system successfully investigated and controlled the outbreak, which would not have been possible without support from the nrc for enteral infections and the cl for hemolytic uremic syndrome (hus). this support would not have been possible without these highly specialized laboratory structures. the work of all other nrcs and cls is also highly relevant, since their work and expertise help in the efforts to contain and prevent higher levels of infectious disease. nevertheless, there is also room for improvement in germany. for example, the anticipating of new outbreak situations that might require cooperation with the responsible veterinarian and food authorities or with other national authorities should be the focus of optimization plans. the creation of a prospective network of eu-wide public health microbiology reference laboratories is currently being discussed within the european union, which will have consequences for the public health laboratory systems of each member state. from this perspective, considerable future challenges to the german public health laboratory system can already be foreseen. thus, the structures established during the past years should be adaptable so that the responding public health infrastructures can react adequately to the upcoming challenges. sandra beermann, franz allerberger, angela wirtz, osamah hamouda and reinhard burger have no financial disclosures to declare. structural requirements and conditions for effective microbiological diagnostics in disease outbreaks legionnaires' disease outbreak associated with a cruise liner core functions of microbiology reference laboratories for communicable diseases epidemiology of infection in germany large and ongoing outbreak of haemolytic uraemic syndrome prioritisation of infectious diseases in public health: feedback on the prioritisation methodology invasive haemophilus influenzae infections in germany: impact of non-type b serotypes in the post-vaccine era a cluster of invasive meningococcal disease in young men who have sex with men in berlin helicobacter pylori resistance to antibiotics in europe and its relationship to antibiotic consumption developing national epidemiologic capacity to meet the challenges of emerging infections in germany contact investigation for imported case of middle east respiratory syndrome reduction in the incidence of invasive pneumococcal disease after general vaccination with -valent pneumococcal conjugate vaccine in germany laboratory diagnosis of paediatric tuberculosis in the european union/european economic area: analysis of routine laboratory data dengue virus infection in a traveller returning from croatia to germany how many outbreaks of nosocomial infections occur in german neonatal intensive care units annually? detection of local influenza outbreaks and role of virological diagnostics epidemiology of streptococcus pneumoniae serogroup isolates from ipd in children and adults in germany scientific advice: crisis counsellors we thank all nrcs and cls for their excellent work during the last years. key: cord- -fs fkidt authors: griffiths, d.; sheehan, l.; van vreden, c.; petrie, d.; grant, g.; whiteford, p.; sim, m.; collie, a. title: the impact of work loss on mental and physical health during the covid- pandemic: findings from a prospective cohort study date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: fs fkidt objective: to determine if losing work during the covid- pandemic is associated with mental and physical health. to determine if social interactions and financial resources moderate the relationship between work loss and health. design: baseline data from a prospective longitudinal cohort study. setting: australia, th march to th june . participants: australians aged + years, employed in a paid job prior to the covid- pandemic who responded to an online or telephone survey. main outcome measures: kessler- score > indicating high psychological distress. short form (sf- ) mental health or physical health component score <= indicating poor mental or physical health. results: , respondents including groups who had lost their job (n= ), were not working but remained employed (n= ), were working less (n= ) and whose work was unaffected (n= ). three groups experiencing work loss had greater odds of high psychological distress (aor= . - . ), poor mental (aor= . - . ) and physical health (aor= . - . ) than the unaffected work group. poor mental health was more common than poor physical health. the odds of high psychological distress (aor= . - . ), poor mental (aor= . - . ) and physical health (aor= . - . ) were increased in those reporting fewer social interactions or less financial resources. conclusion: losing work during the covid- pandemic is associated with mental and physical health problems, and this relationship is moderated by social interactions and financial resources. responses that increase financial security and enhance social connections may partially alleviate the health impacts of work loss. changes in work, including widescale unemployment and reductions in working hours, have been one of the major consequences of public health measures taken to limit transmission of the severe acute respiratory syndrome coronavirus (sars-cov- ), which leads to the coronavirus disease . globally there was an estimated % reduction in working hours during the first half of compared to the last quarter of , equivalent to a loss of million full-time jobs ( ) . in australia, an estimated , workers ( . % of the total employed) lost their jobs between february and may after widespread public health measures to contain covid- were introduced, while in may a further . million remained employed but were working less or were stood down ( ). a coronavirus-induced recession with widespread job losses has potential to lead to an epidemic of mental illness, chronic disease and mortality ( ) . australian data demonstrates a higher than normal prevalence of stress, anxiety and hopelessness among the general community during the covid- pandemic ( ) , and elevations in the community prevalence of depression and anxiety symptoms ( ). work and health are closely interconnected. there is substantial evidence globally of the health benefits of good work ( ). the harmful health impacts of losing work are also well described ( ), including in people whose work is impacted by viral epidemics ( , ) . work loss both disrupts social connections and reduces material financial resources, which are important determinants of health ( , ). the response to the employment crisis by the australian government has been temporary wage subsidies ( ) , and increases in social security payments ( ) , to ensure workers maintain employer connections and a source of income. the ability of australian workers to maintain social interaction has been challenged by physical distancing, isolation, movement restriction and working from home requirements. the health of those that have maintained higher levels of social interaction, and who have greater financial resources, may be less impacted by work loss. this study aimed to determine whether losing work during the covid- pandemic is associated with poorer mental and physical health, and to determine if financial resources and social interactions moderate the relationship between work loss and health. we hypothesised that a gradient in work loss would be reflected in a health gradient, with the most affected group (the newly unemployed) reporting the worst health status. we report findings from a baseline survey of a prospective longitudinal cohort study of people living in australia, aged at least years, and who were employed in a paid job or self-employed prior to the covid- pandemic. participants completed a -minute baseline survey upon enrolment (either online or via a telephone survey) between th march and th june , which included both standardised health metrics and a range of study-specific questions. the online survey was promoted via social and general media, through personal networks, and via newsletters distributed by community sector and industry groups. participants were enrolled into the telephone survey via random digit dialling conducted by a thirdparty market research company. four study groups were defined on the basis of changes in work and job loss at the time of the baseline survey: (i) lost job -those who had lost their jobs during the covid- pandemic and were not working, (ii) off-work -those still employed but not currently working (e.g. stood down, furloughed, taking leave), (iii) reduced work -those still employed and working fewer hours than before the pandemic (e.g. reduced fraction, fewer days working), and (iv) work unaffected -those employed and working the same or more hours as before the pandemic. psychological distress was assessed using the kessler scale ( ) , distinguishing levels of serious mental illness ( ) . mental and physical health were assessed using the mental component score and the physical component score of the short form (sf- ) scale ( ) . outcome measures were derived using standardised approaches and included whether the respondent recorded: . cc-by-nc-nd . international license it is made available under a perpetuity. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint -a kessler- score of more than indicating high psychological distress -a sf- mental health component score of less than indicating poor mental health. -a sf- physical health component score of less than indicating poor physical health. financial resources were assessed with the question: 'if all of a sudden you had to get $ for something important, could the money be obtained within a week?' ( ) . responses of 'yes' were categorised as having more financial resources and responses of 'no' and 'don't know' as having less financial resource. social interactions were measured using the social interaction sub-scale of the duke social support index ( ) . scores were dichotomised with reference to the cohort median as ( ) less social interaction for scores less than , or ( ) high levels of social interaction for scores greater than or equal to . other survey items included a range of sociodemographic, work history and health characteristics including age, gender, household circumstances, personal income, pre-covid- occupation and working hours, and the presence of pre-existing medical conditions. the work-health relationship was modelled using binary logistic regression with working status group as the independent variable. models included interaction terms between working status with social interaction, and working status with financial resources, in addition to adjusting for age, gender, preexisting medical conditions and survey mode. the reference group for interaction terms was the unaffected work subgroup with more social interactions and more financial resources. pre-existing diagnosed anxiety and depression were included as variables in models for psychological distress and mental health. for the physical health model, a diverse set of health conditions were compiled into the total number of medical conditions variable. preliminary analysis identified differences in cohort profiles and outcomes between survey modes and thus a variable for survey mode was also included. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . the odds of poor physical health, for those with a more social interaction and more financial resources, were significantly higher for those in the three work loss groups (aor= . - . ) compared with the unaffected work group. less social interaction was associated with greater odds of poor physical health across all working status groups (aor= . - . ), as was less financial resources (aor= . - . ). a total of ( . %) respondents reported having at least one pre-existing medical condition, including ( . %) with anxiety and ( . %) with depression (table ) . respondents who reported anxiety or depression had greater odds of high psychological distress and poor mental health. for physical health, each additional medical condition reported increased the odds of poor physical health by . . female respondents had greater odds of poor mental health than male respondents. age-related differences were observed across all health outcomes. older respondents had lower odds of psychological distress and poor mental health than the reference group of those aged to years old, but higher odds of poor physical health. respondents who completed the survey online had greater odds of high psychological distress and poor mental health and lower odds of poor physical health compared to those completing the survey via telephone. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint this study demonstrates that in a cohort of people employed prior to the covid- pandemic, those experiencing work loss are more likely to report psychological distress, and poor mental and physical health compared to those whose work was unaffected. these negative health effects are exacerbated in people reporting fewer financial resources and those reporting lower levels of social interaction. these findings demonstrate that financial hardship and social connections moderate the relationship between work and health in the extraordinary circumstances of the covid- pandemic ( ). strategies that promote social interactions and increase financial security in those experiencing job or work loss may help to minimise negative health impacts. the odds of high psychological distress were greatest in people reporting lower financial resources. among these respondents, the greatest odds of distress were reported by people who had lost their job, followed by those who were off work, those with reduced working hours and finally by those whose work was unaffected. the odds of poor mental and physical health were also greater in people reporting lower financial resources. the links between financial resources and health, particularly mental health, are well established ( ). our data additionally show that lower access to financial resources exacerbates the negative health consequences of work loss. people with lower financial reserves and more likely to report increases in financial stress ( ). potential interventions to ameliorate these impacts include increasing the financial support available to those who have lost work during the pandemic, and supporting people to manage their existing financial resources. the australian government introduced two major economic stimulus programs to provide financial support to people whose work was affected during the covid- pandemic ( , ) . our findings suggest that these economic measures may have had positive health consequences, by reducing the number of people in financial stress early during the pandemic. conversely, withdrawal of these measures will reduce access to financial resources and may result in a worsening of mental and physical health among working age australians. enhancing access to services such as financial planning or financial counselling may also be helpful. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint we also observed that social interactions moderated the work-health relationship. social support is an important determinant of health. loneliness and social isolation have been associated with increased mortality, as well as adverse physical and mental health outcomes ( ). during the covid- pandemic social interactions have been transformed by the public health measures introduced to reduce viral transmission. the ability to participate in activities that support health such as working or volunteering, meeting in groups, participating in clubs and sporting groups ( ) have all been reduced. importantly, we observe that the moderating impact of lower social isolations on mental health and psychological distress was limited to people in the lost job, off work and reduced work groups. those whose work was unaffected and who reported low social interactions did not report elevated distress or poorer mental health than their counterparts with more social interactions, suggesting a protective effect of continued engagement in work. our data also provide some evidence for a gradient in health that can be related to the extent of work loss. those in the job loss group had the greatest odds of reporting high psychological distress, poor mental and physical health than those in the other study groups. those in the unaffected work group had the lowest odds of reporting these adverse health outcomes, while the reduced work and off work groups were intermediate. economic recovery from the pandemic is likely to be a long-term process, and is unlikely to be evenly spread across society. a second wave in community transmission in victoria ( ) has led to further job and work losses, more stringent movement restrictions, and business closures. some industries and occupations are at greater risk of pandemic-linked work loss than others ( ), due to the inability to work remotely or enforce physical distancing, the rate of insecure and casual work arrangements, the risk of workplace transmission to employees or members of the public, or being considered 'nonessential' and thus more susceptible to business closure during outbreaks. health-promoting programs should be targeted to people working in these high-risk industries and occupations, and to those whose working arrangements mean they are ineligible for alternative forms of financial assistance. to our knowledge, this is one of the first studies examining psychological distress, mental and physical health, specifically among people losing work during the covid- pandemic. study is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . strengths include the use of validated measurement instruments, the temporal proximity of data collection to job and work loss and that the analysis accounted for multiple confounders. study limitations include its cross-sectional nature and reliance on self-report. the sample may not be representative of the population affected, although the regression model adjusts for multiple demographic factors to aid outcome interpretation. significant differences were observed between survey modes, with online respondents more likely to report mental health problems and less likely to report physical health problems than telephone respondents. using multiple response modes and statistically controlling for response mode in regression models may have reduced the response biases commonly observed in health outcomes research ( ). data collection began at the peak of a first wave of covid- cases in australia and continued through the early stages of re-opening. longitudinal data from this cohort will track changes in work and employment amongst the study groups, and examine longer-term impacts of mental and physical health as the pandemic unfolds in australia. we acknowledge the social research centre (src) for undertaking telephone interviews. funding was provided by monash university and the icare foundation. the views expressed are those of the authors and may not reflect the views of study funders. professor alex collie is supported by an arc future fellowship. no relevant disclosures is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint committee. the data are held at monash university, insurance work and health group, school of public health and preventive medicine. procedures to access data from this study are available through contacting the lead author. proposals for collaborative analyses will be considered by the study's investigator team. . cc-by-nc-nd . international license it is made available under a perpetuity. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted september , . . https://doi.org/ . / . . . doi: medrxiv preprint fifth edition updated estimates and analysis. international labour organization will there be an epidemic of corollary illnesses linked to a covid- -related recession? household impacts of covid- survey $ billion jobkeeper payment to keep australians in a job, media release prime minister of australia) , supporting australian workers and business, media release short screening scales to monitor population prevalences and trends in non-specific psychological distress screening for serious mental illness in the general population. archives of general psychiatry the sf- v tm how to score version of the sf- ® health survey:(with a supplement documenting version ). quality metric abbreviating the duke social support index for use in chronically ill elderly individuals note: all data is reported as number (row percentage) unless otherwise stated. sd = standard deviation key: cord- -l wjwn authors: fiorillo, andrea; sampogna, gaia; giallonardo, vincenzo; del vecchio, valeria; luciano, mario; albert, umberto; carmassi, claudia; carrà, giuseppe; cirulli, francesca; dell’osso, bernardo; nanni, maria giulia; pompili, maurizio; sani, gabriele; tortorella, alfonso; volpe, umberto title: effects of the lockdown on the mental health of the general population during the covid- pandemic in italy: results from the comet collaborative network date: - - journal: european psychiatry : the journal of the association of european psychiatrists doi: . /j.eurpsy. . sha: doc_id: cord_uid: l wjwn background: the coronavirus disease (covid- ) pandemic is an unprecedented traumatic event influencing the healthcare, economic, and social welfare systems worldwide. in order to slow the infection rates, lockdown has been implemented almost everywhere. italy, one of the countries most severely affected, entered the “lockdown” on march , . methods: the covid mental health trial (comet) network includes italian university sites and the national institute of health. the whole study has three different phases. the first phase includes an online survey conducted between march and may in the italian population. recruitment took place through email invitation letters, social media, mailing lists of universities, national medical associations, and associations of stakeholders (e.g., associations of users/carers). in order to evaluate the impact of lockdown on depressive, anxiety and stress symptoms, multivariate linear regression models were performed, weighted for the propensity score. results: the final sample consisted of , participants. among them, . % of respondents (n = , ) reported severe or extremely severe levels of depressive symptoms, . % (n = , ) of anxiety symptoms and . % (n = , ) reported to feel at least moderately stressed by the situation at the dass- . according to the multivariate regression models, the depressive, anxiety and stress symptoms significantly worsened from the week april – to the week april to may (p < . ). moreover, female respondents and people with pre-existing mental health problems were at higher risk of developing severe depression and anxiety symptoms (p < . ). conclusions: although physical isolation and lockdown represent essential public health measures for containing the spread of the covid- pandemic, they are a serious threat for mental health and well-being of the general population. as an integral part of covid- response, mental health needs should be addressed. there is no doubt that the coronavirus disease (covid- ) pandemic, and its related containment measures such as lockdown, is affecting mental health of the general population worldwide [ ] [ ] [ ] . this is an unprecedented event, which is influencing the healthcare, political, economic, and social systems [ ] . given the high level of contagiousness, as well as the lack of appropriate treatments and vaccines, almost all countries have adopted confinement measures, including lockdown, home isolation and physical distancing [ ] . while most of the clinical and research efforts have been directed to reduce the effects of the virus on physical health [ ] [ ] [ ] , its short-and long-term effects on mental health are causing a second wave of pandemic, which has been mostly neglected [ ] [ ] [ ] . furthermore, the pandemic represents a traumatic event which has differential effects at individual and population levels. at the individual level, high rates of depression, anxiety, fear, panic, anger, and insomnia have been documented in studies mainly carried out in china or from short-term reports [ ] [ ] [ ] . at the population level, the pandemic is associated with a range of psychosocial adversities, including economic hardship and financial losses (due to unemployment and reduced income), school closures, inadequate resources for medical response, domestic violence, and deficient distribution of basic good necessities [ ] . the psychopathological consequences include the fear of contracting the disease and of dying, losing livelihoods and loved ones, uncertainty and worries about the future, social discrimination, and separation from families and caregivers [ ] [ ] [ ] [ ] . this is why the current pandemic represents a new, complex and multifaceted form of psychosocial stressor [ ] , being completely different from other natural disasters [ ] , such as earthquakes or tsunamis [ , ] , wars, terroristic attacks, mass conflicts, or economic crisis [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , and also from previous epidemics, such as severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) and ebola [ , ] . italy has been the first western country heavily affected by the pandemic, and it has been the country with the highest number of infected and dead people for many weeks [ ] . on march , , the italian prime minister has placed million people under lockdown. this measure has been prolonged for weeks, until may , . this period is known as "phase one," during which all not necessary activities have been closed, more than , people have died and almost , people have been homeisolated. during the initial phase of the pandemic, the outbreak in italy seemed to have a greater severity of the disease, with a higher case fatality rate (cfr) than previously observed in china ( . vs. . %) [ ] . the excess in covid- mortality was higher in men than in women living in northern cities versus in central and southern italy (men: + % and + % and women: + % and + %, respectively), with an increasing trend by age [ ] . from may , a gradual reopening of financial and commercial activities has taken place (known as "phase two" of the national sanitary emergency). a few, short-term studies have already shown the impact of lockdown on the mental health of the italian general population in the first days of "phase one" [ ] [ ] [ ] . we have decided to carry out an online survey using several validated assessment instruments in order to evaluate the impact of the lockdown on the mental health of italian population throughout the different weeks of phase one [ ] . in particular, in this paper we aim to: (a) report the levels of depressive, anxiety and stress symptoms in a large sample of the italian general population; (b) explore the levels of depressive, anxiety and stress symptoms during the different weeks of lockdown; and (c) identify possible risk and protective factors for mental health outcome. the covid mental health trial (comet) is a national trial coordinated by the university of campania "luigi vanvitelli" (naples) in collaboration with nine university sites: università politecnica delle marche (ancona), university of ferrara, university of milan bicocca, university of milan "statale", university of perugia, university of pisa, sapienza university of rome, "catholic" university of rome, university of trieste. the center for behavioral sciences and mental health of the national institute of health in rome has been involved in the study by supporting the dissemination and implementation of the project according to the clinical guidelines produced by the national institute of health for managing the effects of the covid- pandemic. the comet trial includes three phases: phase one consists in the dissemination of a survey on the impact of lockdown and its related containment measures on the mental health of the italian general population; the second phase consists in the development of a new psychosocial online supportive intervention [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] for the management of the consequences on mental health of the pandemic; the last phase consists in the evaluation of the efficacy and feasibility of the experimental psychosocial intervention in a randomized control trial. the results of phase are described in this paper. the study has been approved by the ethical review board of the coordinating center (protocol number: /i). the primary outcome of the study is the severity of depressive-anxiety symptoms evaluated with the depression, anxiety, stress scale (dass- ) [ ] . secondary outcomes include the levels of global mental health status, of obsessive-compulsive and post-traumatic symptoms, presence and severity of insomnia, the levels of perceived loneliness and the presence of suicidal ideation/suicidal thoughts. furthermore, exploratory variables include coping strategies, levels of post-traumatic growth, perceived social support and resilience. the dass- evaluates the general distress on a tripartite model of psychopathology [ ] and is a reliable and valid measure in assessing mental health in the general population [ ] , which has been already adopted in previous research on sars [ ] and covid- [ , ] . the dass consists of items grouped in three subscales: depression, anxiety, and stress. each item is rated on a -level likert scale, from (never) to (almost always). the total score is calculated by adding together the response values of each item, with higher scores indicating more severe levels of depressive, anxiety, and stress symptoms. the score at the dass-depression subscale (e.g., "i felt that i had nothing to look forward to") is divided into normal ( - ), mild ( ) ( ) ( ) , moderate ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , severe ( ) ( ) ( ) ( ) ( ) ( ) ( ) , and extremely severe depression ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the score at the dass-anxiety subscale (e.g., "i was worried about situations in which i might panic and make a fool of myself") is divided into normal ( - ), mild ( - ), moderate ( ) ( ) ( ) ( ) ( ) , severe ( ) ( ) ( ) ( ) ( ) , and extremely severe anxiety . the score at the dass-stress subscale (e.g., "i tended to over-react to situations") is divided into normal ( - ), mild ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , moderate ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , severe ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , and extremely severe stress ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the general health questionnaire (ghq)- items version explores participants' mental health status through six positively worded items (e.g., "have you been able to concentrate"?) and six negatively worded items (e.g., "have you lost much sleep over worry?"). the standard scoring method recommended by goldberg for the need of case identification is called "ghq method." scores for the first two types of answers are " " (positive) and for the other two are " " (negative). threshold ≥ at ghq identifies people with a probability > % of having a mental health problem [ ] . the obsessive-compulsive inventory-revised version (oci-r) consists of items rated on a -level likert scale, ranging from to . the total score is calculated by adding all single items. scores above the threshold of are indicative of an ocd diagnosis [ ] . the insomnia severity index (isi) includes seven items rated on a -level likert scale (from to ), with a total score ranges from to [ ] . the suicidal ideation attributes scale (sidas) consists of five items assessing frequency, controllability, closeness to attempt, level of distress associated with suicidal thoughts and impact on daily functioning. each item is assessed on a -level likert scale, with a total score ranging from to . in case of scoring " -never" to the first item, all other items are skipped, and the total score is zero. the presence of any suicidal ideation is considered indicative of risk for suicidal behavior, while a cut-off of is used to indicate high risk of suicidal behavior [ ] . the severity-of-acute-stress-symptoms-adult scale (sass), which consists of nine items rated on a -point scale (from = not at all to = extremely), has been used to assess the presence of traumatic stress symptoms. the total score ranges from to , with higher scores indicating a greater severity of acute stress disorders [ ] . the impact of event scale (ies)-short version measures the traumatic reactions in people who have experienced traumatic events. each item is rated on a -point scale ranging from (not at all) to (often). the ies evaluates the dimensions of intrusion, avoidance, and alteration in arousal [ ] . the ucla loneliness scale-short version is an eight-item scale designed to measure subjective feelings of loneliness, as well as feelings of social isolation. each item is scored on a -level likert scale from = never to = often [ ] . the brief-cope consists of items grouped in subscales [ ] . each item is rated on a -level likert scale from = "i have not been doing this at all" to = "i have been doing this a lot." coping strategies are divided in maladaptive strategies, including denial, venting, behavioral disengagement, self-blame, self-distraction and substance abuse, and adaptive coping strategies, which include emotional support, use of information, positive reframing, planning and acceptance. two other subscales include religion and humour. the short form of post-traumatic growth inventory (ptgi) is a -item assessment instrument grouped into five dimensions: relating to others, new possibilities, personal strengths, spiritual change, and appreciation of life. items are rated on a -point likert scale, from = "i did not experience this change as a result of my crisis" to = "i experienced this change to a very great degree as a result of my crisis". higher scores indicate higher levels of post-traumatic growth [ ] . the connor-davidson resilience scale (cd-risc), which includes items rated on a -level likert scale, is subdivided into the following five factors: (a) personal competence, high standards, and tenacity; (b) trust in one's instincts, tolerance of negative affect, and strengthening effects of stress; (c) positive acceptance of change and secure relationships; (d) control; and (e) spiritual influences. higher values indicate higher levels of resilience [ ] . the multidimensional scale of perceived social support (mspps) consists of items rated on a level-likert scale, from = "absolutely false" to = "absolutely true". items are grouped into three dimensions: family support, support by friends and support by significant others. higher values correspond to higher levels of perceived support [ ] . the maslach burnout inventory (mbi) has been used to evaluate the levels of burn-out in medical personnel [ ] . data regarding healthcare professionals are not included in this paper since they are out of the aims of the study and will be reported in subsequent analyses. respondents' socio-demographic (e.g., gender, age, geographical region, working and housing condition, etc.) and clinical information (e.g., having a previous physical or mental disorder, using illicit drugs or medications, etc.) have been collected through an ad-hoc schedule. the phase one of the comet trial consists in an online survey carried out between march and may in the italian adult population. the survey has been implemented through a multistep procedure: (a) email invitation to healthcare professionals and their patients; (b) social media channels (facebook, twitter, instagram); (c) mailing lists of universities, national medical associations and associations of stakeholders (e.g., associations of users/carers); and (d) other official websites (e.g., healthcare or welfare authorities websites). the online survey has been set up through eusurvey, a web platform promoted by the european commission ( ). the survey has been officially launched on march , , and it takes approximately min (range - min) to be completed. the full study protocol is available elsewhere [ ] . descriptive statistics were performed in order to describe the sociodemographic and clinical characteristics of the sample. the time points of data collection were recorded and coded using the variable "week" . therefore, geographical regions of respondents were recoded using a binary variable "severely impacted area." this variable has been entered in the regression model in order to evaluate the direct impact of living in an area with a higher risk of being infected rather than the impact of geographical area per se. we hypothesized that individuals living in the most affected areas should have presented more severe symptoms compared with those living in less affected areas. by order of the italian health authority, persons subject to quarantine are forbidden to move from home or residence for days, with the aim to separate persons exposed (or potentially exposed) to the infectious agent from the general community for reducing the contagion rate. people who have been subjected to those restrictions were coded using the binary variable "quarantine." in order to adjust for the likelihood of participants of being exposed to covid infection in each week, a propensity score was calculated [ ] . this methodological choice was due to the fact that the propensity score produces a better adjustment for differences at baseline, rather than simply including potential confounders in the multivariable models. the propensity score was calculated using as independent variables age, gender, socioeconomic status and living in a severely impacted area [ ] . in the final regression model, the inverse probability weights, based on the propensity score, were applied in order to model for the independence between exposure to the infection, outcomes and estimation of causal effects. in order to evaluate factors associated with the severity of depressive, anxiety and stress symptoms at dass- (primary outcomes), multivariate linear regression models were performed, including as independent variables: being infected by covid- , having a pre-existing mental disorder, being a healthcare professional. furthermore, in order to evaluate the impact of the duration of lockdown and of other related containment measures on the primary outcomes, the categorical variable "week" was also entered in the regression models. the models were adjusted for the rate of new covid cases and of covid-related mortality during the study period, as well as for several socio-demographic characteristics, such as gender, age, occupational status, having a physical comorbid condition, hours spent on internet, levels of perceived loneliness, health status, number of cohabiting people, level of satisfaction with one's own life, with cohabiting people, with the housing condition. missing data have been handled using the multiple imputation approach [ ] . statistical analyses were performed using the statistical package for social sciences (spss), version . and stata, version . for all analyses, the level of statistical significance was set at p < . . the final sample consisted of , participants, % female (n = , ), with a mean age of . ( . ) years; half of respondents were in a stable relationship, living with the partner ( . %, n = , ) ( table ). the vast majority of participants were employed ( . %, n = , ) and . % (n = , ) shifted to smart working during the pandemic. (n = , ) of respondents lost their job during the pandemic. % spent more time on internet than usual, more frequently for instant messaging ( . %, n = , ), searching for information ( . %, n = , ), or using social networks ( . %, n = , ). about . % of cases (n = , ) suffered from a pre-existing physical illness, mainly cardiovascular diseases ( . %), osteo-articular disorders ( . %), thyroid dysfunctions ( %), and diabetes/dyslipidaemia ( . %). . % (n = , ) reported to have a pre-existing mental disorder, more frequently anxiety ( . %) and depressive disorders ( . %). % of respondents (n = , ) were healthcare professionals. almost all participants ( . %, n = , ) scored above the threshold of at the ghq, indicating the risk of having any mental health problem. in particular, depressive symptoms were moderate in . % of respondents (n = , ) and severe or extremely severe in . % (n = , ); anxiety symptoms were moderate in . % (n = , ) of respondents and severe or extremely severe in . % (n = , ); stress symptoms were at least moderate in . % (n = , ) ( table ) . moderate to severe levels of insomnia were found in . % of respondents (n = , ). about . % (n = , ) of the sample scored above the threshold for clinical relevance of obsessivecompulsive symptomatology, with a global severity of obsessivecompulsive symptoms of . (ae . ) at oci-r. suicidal ideation is reported by . % (n = , ) of the sample, with a mean score of . ( . ) at the sidas. participants showed high levels of avoidance and hyperarousal symptoms ( . ae . and . ae . , respectively), with lower levels of intrusive symptoms ( . ae . ) at the ies-r. . % (n = , ) reported to feel alone, . % (n = , ) to feel excluded by others and . % (n = , ) feel that "other people are around them, but not together with them", at the ucla. at the brief-cope, we found that respondents more frequently used adaptive coping strategies, such as planning ( . % of participants, n = , ), acceptance ( . %, n = , ), and active coping ( . %, n = , ). as regards maladaptive coping strategies, . % (n = , ) of the sample used venting, % (n = , ) self-blame and . % (n = , ) self-distraction. moreover, a relatively high proportion of respondents ( . %; n = , ) reported to use psychoactive medications in order to cope with the situation. at the ptgi, participants reported that they found "something positive" out of this situation, with high levels of "appreciation for life" ( . %, n = , ), feeling closer to other people ( . %, n = , ), being more satisfied of everyday life ( . %, n = , ) and increased ability to handle difficult situations ( . %, n = , ). furthermore, respondents reported a good level of resilience with a mean score of . ae . at the cd-risc. finally, the majority of participants declared to feel supported by family ( . %, n = , ) and friends ( . %, n = , ), with a mean score of . ae . at the mspps family support subscale and of . ae . at the mspps friend support subscale (table ) . the levels of depressive symptoms increased over the period of the lockdown. in particular, depressive symptoms changed from . ae . in the week march to april to . ae . in the week april to may (p < . ). anxiety symptoms increased from . ae . in the week march to april to . ae . in the week april to may (p < . ). furthermore, the levels of stress symptoms increased from . ae . in the week march to april to . ae . in the week april to may (p < . ). these increases were higher in female participants compared to males (figures - ; p < . ). the multivariate regression analyses are reported in table . according to the multivariate regression models, weighted for the propensity score, weeks of exposure to the pandemic and to the related containment measures were significantly associated with worsening of depressive symptoms, with beta coefficient ranging from . ( % confidence interval, ci: . - . protective factors against the development of psychiatric symptoms included higher levels of satisfaction with one's own life and with cohabiting people, and living with a higher number of family members (p < . ). the comet is the first trial evaluating the global impact of the covid- pandemic and its related containment measures on several dimensions of mental health in a large sample of the italian population. one of our main findings is the presence of moderate to severe levels of depressive, anxiety, and stress symptoms which are higher than those found in china [ , , ] . this difference could be due to the type of immediate health response in the two countries, with clear lockdown measures from the beginning of the pandemic in china [ ] and a more fragmented preventive approach in italy, which may have increased the levels of fears and uncertainty in this country [ ] [ ] [ ] ] . in fact, the uncertainties about the pandemic progression, the "hypochondriac concerns" [ ] and fear that the epidemic is difficult to control represent triggering factors for the development of mental health problems [ , ] . moreover, studies carried out during natural disasters, war, fires and terroristic attacks found high levels of depressive/anxiety-related symptoms in the general population [ ] [ ] [ ] [ ] [ ] [ ] [ ] , but nevertheless they were significantly lower compared to those we found in our study. these data confirm that the current pandemic is an unprecedented event in terms of its impact on the mental health of the general population. a second interesting finding of our survey is that the levels of anxiety, depressive and stress symptoms increased over time, being more severe in the last weeks of the lockdown, as also found in our regression models controlled for all socio-demographic characteristics of respondents. this finding confirms the hypothesis that the duration of containment measures significantly influences mental health and well-being of the general population, as also found by sibley et al. [ ] in a sample of the general population in new zealand. moreover, this trend has not been influenced by the rate of covid cases and covid mortality rates in italy, highlighting that these public measures-although being necessary for infection control-should be removed as soon as possible in order to safeguard public mental health. female participants are at higher risk of developing depressiveanxiety symptoms, as already shown in small italian samples [ , ] and in previous outbreaks [ ] . this finding can be due to the higher incidence in women of anxiety-depressive disorders [ ] [ ] [ ] [ ] and of anxious, cyclothymic and depressive temperaments in women [ ] , also in community-based samples [ ] . moreover, being affected by a pre-existing mental health problem represents an independent significant risk factor for the development of depressive, anxiety and stress symptoms, as already reported by plunkett et al. [ ] and hao et al. [ ] . this finding suggests the need to provide as soon as possible adequate and tailored supportive interventions to mentally ill patients, who represent fragile and at-risk individuals that have been overlooked during the initial phases of the pandemic [ ] [ ] [ ] [ ] [ ] . during the lockdown participants reported an increased time spent on internet, which was associated with a higher risk of developing mental health problems, thus not confirming our hypothesis of a protective effect played by internet on mental health. this finding may be due to the diffusion through internet of uncontrolled and unreliable information and fake news, which may have increased the levels of anxiety and depressive symptoms in people who are alone and with lower levels of education [ ] . this finding highlights the need for media professionals to receive an appropriate training, in order to provide unbiased and nonsensationalistic information during catastrophic events. being unemployed, retired or housewife was significantly associated with higher levels of anxiety-depressive symptoms [ ] . in the uk, belonging to a socio-economic disadvantaged group increased the risk of developing mental health problems, according to a gradient across the different weeks of the lockdown [ ] . this finding highlights the need for global, multi-level socio-economic initiatives aiming to reduce the negative effect of the pandemic on the society [ ] . these data should also be interpreted considering the high rate ( . %) of suicidal ideation/suicidal thoughts found in our sample. the rate of suicidal ideation found in our sample is quite impressive, compared with the % found in a previous epidemiological study carried out in italy [ ] . several factors may contribute to the increased rate of suicidal ideation in the italian general population, including uncertainty about the future, loneliness, physical distancing, unemployment, economic recession and interpersonal violence [ ] . all these risk factors should be taken into account in the implementation of actions aiming to prevent suicide [ ] [ ] [ ] . participants reported several disturbances in sleep quality and patterns, as already found in other studies carried out in china and in other european countries [ , ] . the public health containment measures implemented worldwide have markedly changed daily routines and may have had an impact on sleep pattern and on the risk of developing other mental health problems [ , ] . in order to develop tailored innovative preventive and/or therapeutic strategies, the specific socio-demographic and clinical predictors of sleep problems should be identified. finally, good levels of perceived social support and of posttraumatic growth in the aftermath of the pandemic have been reported from the italian general population participating in our survey. it may be that the italian socio-cultural context, with strong family ties and social relationships, may have positively impacted on the perception of mutual social support [ ] . however, longitudinal studies may help to evaluate changes in the levels of posttraumatic growth, resilience, and social support in the subsequent phases of the ongoing health crisis [ ] . our study has several strengths. this is the first study carried out in different geographic italian regions with a large sample from the general population during the lockdown period. validated and reliable assessment instruments have been used in order to investigate several domains of mental health and psychological wellbeing according to a propensity score analysis. moreover, as primary outcome we have selected the same assessment tool (the dass- ) used in studies carried out in china in order to allow direct comparisons between the two countries. although the dass- scores in the italian general population prior of the pandemic are not available, the comparison of our findings with national statistics (https://www.epicentro.iss.it/mentale/epidemiologia-italia) document higher levels of anxiety, depressive and stress symptoms during the pandemic. therefore, the increased frequency of depressive-anxiety symptoms in our sample could be interpreted as covid- related, although this causal association should be further investigated. in any case, we believe that the analysis of dass- over the different weeks of lockdown provide an important contribution to the field in order to clarify the direct impact of the pandemic on the mental health. we are aware that the use of an online tool is not the best methodological choice, since it may have excluded elderly people or those living in socially disadvantaged contexts [ ] . however, this choice was necessary in order to reach a large portion of italian population in a short time and in a pandemic situation, when faceto-face contacts are forbidden [ ] . finally, it must be acknowledged that collected data are related to depressive or anxiety symptoms, which cannot be considered as sufficient to formulate a diagnosis of depressive/anxiety disorders. therefore, this survey represents an initial step for the promotion of appropriate screening procedures in the general population for the early detection of full-blown mental disorders. the present study has several clinical implications: (a) to promote mass screening campaigns for the general population in order to identify the presence of subthreshold mental disorders; (b) to disseminate informative intervention on how to deal with the mental health consequences of the pandemic; and (c) to support at-risk population-mainly people with pre-existing mental health problems and covid- patients-with tailored innovative psychosocial interventions. in conclusion, there is the need to address mental health needs as an integral part of covid- response. in fact, although physical isolation and lockdown represent essential public health measures for containing the spread of the covid- pandemic, they are a serious threat for mental health and well-being of the general population. it is necessary to get prepared if a next emergency will come, in order to provide appropriate community-based mental health service responses to the population. financial support. this research received no specific grant from any funding agency, commercial or not-for-profit sectors. conflicts of interest. the authors have no conflicts of interest to disclose. data availability statement. the dataset is not available for sharing. ethical standards.the authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the helsinki declaration of , as revised in . the ethical review board of the university of campania "l. vanvitelli" has approved the study. the consequences of the covid- pandemic on mental health and implications for clinical practice psychological adjustment 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social research . : virtual snowball sampling method using facebook says who? the significance of sampling in mental health surveys during covid- key: cord- -lxlerb authors: lim, w.s; anderson, s.r; read, r.c title: hospital management of adults with severe acute respiratory syndrome (sars) if sars re-emerges—updated february date: - - journal: j infect doi: . /j.jinf. . . sha: doc_id: cord_uid: lxlerb severe acute respiratory syndrome (sars) is a potentially severe and highly infectious disease to which healthcare workers involved in the management of cases are particularly vulnerable. these guidelines briefly summarise optimal and safe practice for clinicians involved in the emergency care of patients with probable or confirmed sars. during severe acute respiratory syndrome caused by a novel coronavirus (sars-cov) emerged as an infectious disease with a significant inhospital mortality and posed a considerable occupational risk for healthcare workers. - the initial sars outbreak ended in july when the world health organisation (who) announced that all known person-to-person transmission of sars-cov had ceased. at the time of preparation of these guidelines, there have been a further two laboratory-acquired cases of sars and further community-acquired cases. these cases emphasise the potential for sars to re-emerge and spread unpredictably. these guidelines document the hospital management of adults with probable or confirmed sars. they are meant only as a brief summary for clinicians. these guidelines do not cover the management in the community of a person under investigation (pui) (see case definitions). guidelines for the management of paediatrics cases have not yet been developed. as more information about sars becomes available, guidance will be appropriately updated. please consult the latest guidance available on the websites of the british thoracic society (http:// www.brit-thoracic.org.uk/) and health protection agency (http://www.hpa.org.uk/infections/ topics_az/sars/menu.htm). the following case definitions (see tables - ) are designed for use during an outbreak of sars, once the re-emergence of sars has been verified by the world health organisation (who). it is anticipated that patients with sars will have a respiratory illness severe enough to warrant hospital admission. management of such cases is covered in sections - . a person with a mild respiratory illness and a potential epidemiological link to sars should be defined as a pui (see table ) and should be assessed in primary care and reviewed within h. a pui does not require routine hospitalisation nor do they require a chest radiograph (cxr) or laboratory investigation for sars cov as part of their assessment. a pui should only be hospitalised if his or her condition deteriorates. the management of such patients is covered in section . if these patients are subsequently found to have radiographic evidence consistent with sars, they should be reclassified as a 'probable sars' case unless an alternative diagnosis is made. a pui should be reported to local health protection units but does not need to be reported to cdsc colindale. please discuss the classification of sars patients with the health protection agency's communicable disease surveillance centre (cdsc) duty doctor (tel.: - - ) and complete a standard sars report form and fax to your local consultant in communicable disease control (ccdc) and cdsc (details at: http://www.hpa.org.uk/infections/ topics_az/sars/forms.htm). † negative antibody test on acute serum followed by positive antibody test on convalescent phase serum tested in parallel or † four-fold or greater rise in antibody titre between the acute and convalescent phase sera tested in parallel (c) virus isolation † isolation in cell culture of sars-cov from any specimen; plus pcr confirmation using a validated method patients are likely to present initially with a clinical picture of pneumonia which may be consistent with sars. therefore, other causes of pneumonia should be considered. confirmation that a patient has sars may occur following further investigation. detailed guidance regarding the infection control issues during hospital management of a patient, or patients, presenting with sars can be found at the hpa website: http://www.hpa.org.uk/infections/ topics_az/sars/hops_infect_cont.htm. briefly, the key recommendations are: (a) give the patient a surgical mask to wear continuously (unless requiring face mask for oxygen confirm the travel history and/or history of contact with a patient with sars. explore other possible causes of pneumonia. assess pneumonia disease severity according to the bts guidelines on the management of community acquired pneumonia (cap) in adults (http:// www.brit-thoracic.org.uk/guide/guidelines.html). in addition, determine whether the patient has any medical history of illness associated with a more severe outcome of sars, i.e. diabetes and cardiopulmonary disease. obtain investigations as listed below (observe high risk infection control measures for all samples). for full details, please see the hpa website at http://www.hpa.org.uk/infections/topics_az/ sars/micro.htm. only send specimens once cdsc have been informed of a case via their standard report form. please observe strict infection control procedures. all specimens should be double bagged and labelled as a biohazard. do not obtain a nasopharyngeal aspirate as this is likely to generate aerosols. admit the patient to a designated isolation unit (see section . ). manage as for severe cap according to bts guidelines. administer fluids and oxygen as required. commence intravenous co-amoxiclav . g tds or cefuroxime . g tds plus erythromycin mg qds or clarithromycin mg bd. please refer to the bts guidelines for alternative recommended regimens. oxygen supplementation should be administered according to standard/local guidelines. however, in order to reduce the risk of aerosol generation and hence spread of infection, high flow oxygen is not recommended, i.e. avoid oxygen flow rates of . l/min. it should be possible to provide - % oxygen supplementation using a standard low flow oxygen system and an air-entrainer together with a ventimask. procedures and practices that promote the generation of aerosols (table ) should be avoided wherever possible to reduce the risk of infection to healthcare workers. , if such procedures need to be performed, e.g. tracheal intubation, it is advised that experienced operators only should undertake these procedures. these should, where possible, be planned and controlled. these procedures should ideally be undertaken in a negative pressure room. only a minimum number of staff should be present and all must wear gowns, gloves, goggles/visors and respirators as described under infection control issues (see section . ). entry and exit from the room should be minimised during the procedure. the use of powered air purifying respirators (paprs) during aerosol generating procedures is not recommended. this is because there are concerns over the removal, disposal, cleaning and decontamination of this equipment, which may increase the potential risk of self-contamination and at this time there is inadequate evidence to determine whether paprs further reduce the transmission of sars. if paprs are used, staff must be properly trained in their safe use. in studies from canada and singapore, approximately % of patients with suspected or probable sars, according to the prevailing who case definition from march to june , required icu admission. , of these patients, - % required mechanical ventilation. average length of icu stay was days. preplanning and early consultation with local critical care providers is recommended. patients who are likely to require intubation, should be identified early and the procedure should be undertaken electively. in order to avoid the use of cpap or niv, early intubation and invasive positive pressure ventilation (ippv) may be required in some patients with impending respiratory failure. the following issues need to be carefully considered: further guidance for the management of critically ill patients is being developed. the use of high-dose steroids has been anecdotally reported to contribute to decrease in fever and need for oxygen supplementation. a study from guangzhou, china has suggested that the early administration of high-dose steroids together with cpap ventilation is associated with a lower mortality. however, these findings are not based on adequately controlled data and there remain concerns regarding the use of high-dose steroids. the use of cpap is certainly no longer recommended (see section . . ). in a retrospective analysis of hong kong patients who had received ribavirin in combination with different steroid regimens, patients who received initial high dose pulsed methylprednisolone intravenously had less oxygen requirement, better radiological improvement and less likelihood to require rescue pulse steroid use than patients who received non-pulse steroid therapy. however, the overall mortality rate, and requirement for mechanical ventilation or admission to the intensive care unit was the same for both regimens. recommendation the current recommendation is to consider moderate doses of steroid (prednisolone - mg/day or iv equivalent) in severely ill patients with sars with increasing oxygen requirements who have a pao , kpa or o sats , % on air. currently there is no convincing evidence that ribavirin alters clinical outcome. in laboratory studies, no in vitro activity against sars-associated coronavirus (sars-cov) has been consistently demonstrated either. in addition, use of ribavirin is associated with significant toxicity including haemolysis (in , %) and decrease in haemoglobin of g/dl or more (in , %). the routine use of ribavirin in patients with sars is not recommended. the antiviral activity of interferons against sars coronavirus has been measured in vitro and interferon beta appears to be particularly active. the world health organisation is currently coordinating plans for clinical trials of interferons in the event of re-emergence of the disease. recommendation none can be given at this time. generate a list of all close contacts. this should be initiated by the attending physician at the time of first contact with the patient. the local hospital infection control and occupational health teams may need to be involved if any healthcare workers are identified as close contacts. record the date on which all close contacts last had contact with the case and inform them about sars. inform the local ccdc/health protection team of any contacts and their details to ensure follow-up. these contacts may continue with everyday activities, as long as they remain well. the local health protection team will contact them on a regular basis to review their health. these contacts should be isolated at home. please refer to the health protection agency's guidelines on voluntary home isolation at http://www.hpa. org.uk/infections/topics_az/sars/homeiso.htm. if a contact becomes unwell within days of their contact with a probable or confirmed sars case they should phone a doctor urgently. for more information please refer to: http://www.hpa.org. uk/infections/topics_az/sars/guidelines.htm. guidelines for the safe discharge of patients recovering from sars have been published by who. please refer to the who website at http:// www.who.int/csr/sars/discharge/en/. briefly, the following criteria should be considered before discharge: (a) afebrile for h (b) resolving cough (c) laboratory tests, if previously abnormal, returning to normal (d) chest x-ray improved. patients should monitor and record their temperature twice daily. if they have an elevated temperature of c or above on two consecutive occasions they should inform (by telephone) the healthcare facility from which they were discharged. patients should remain at home for days after discharge, keeping contact with others at a minimum. this is to reduce the risk of transmission until more is known regarding the potential for continued carriage in convalescent cases. additional home confinement may need to be considered, particularly in patients who are immunosuppressed. inform the local health protection team/ccdc regarding the hospital discharge of patients to ensure follow-up in the community. a standard follow-up form should be completed and faxed to the local ccdc and cdsc on day , day , and/or once the patient is asymptomatic. forms are available from http://www.hpa.org.uk/infections/ topics_az/sars/forms.htm. follow-up post-discharge will be the responsibility of the local infection control team. convalescent serology should be obtained at days after the date of disease onset. puis who have symptoms and signs consistent with a lower respiratory tract infection (lrti) but have a normal cxr do not fulfil the sars case definition (see table ). patients should be discharged and followed up in primary care unless their symptoms or social circumstances warrant continued hospital care. up to % of patients with probable sars may initially present with normal chest radiographs. therefore, puis who need ongoing hospitalisation require careful medical review in the first h following admission. infection control measures as for patients with probable sars should apply (see section . ) until it is clinically clear that the pui does not have probable sars. such patients should be treated as for non-pneumonic lrti. if the patient improves with treatment in the first h following admission, the likelihood of sars is small. infection control measures may be relaxed and the patient discharged if this is clinically appropriate. if the patient does not improve with initial treatment (either no change or deteriorates), a repeat cxr should be obtained. an abnormal cxr with changes consistent with sars would require the patient to be re-classified as having probable sars and be managed accordingly (see section ). if the repeat cxr remains normal, the patient remains a pui. further repeat cxrs may be required at - days intervals depending on clinical circumstances. a pui should be reported to the local health protection unit but does not need to be reported to cdsc colindale. these guidelines were produced as a joint initiative between the british thoracic society, the british infection society and the health protection agency. membership of the guideline development group: lead clinical features and short-term outcomes of patients with sars in the greater toronto area coronavirus as a possible cause of severe acute respiratory syndrome acute respiratory distress syndrome in critically ill patients with severe acute respiratory syndrome critically ill patients with severe acute respiratory syndrome koch's postulates fulfilled for sars virus effectiveness of precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (sars) clinical progression and viral load in a community outbreak of coronavirus-associated sars pneumonia: a prospective study identification of severe acute respiratory syndrome in canada a major outbreak of severe acute respiratory syndrome in hong kong bts guidelines for the management of community acquired pneumonia in adults severe acute respiratory syndrome (sars): infection control sars: experience at prince of wales hospital, hong kong anaesthesia and sars development of a standard treatment protocol for severe acute respiratory syndrome description and clinical treatment of an early outbreak of severe acute respiratory syndrome (sars) in guangzhou, pr china high dose pulse versus nonpulse corticosteroid regimens in severe acute respiratory syndrome treatment of sars with human interferons useful contact details: scottish centre for infection and environmental health (scieh) telephone: - - e-mail: jim.mcmenamin@scieh.csa.scot.nhs.uk key: cord- -luk cme authors: delamater, alan m; miller, suzanne m; bowen, deborah j; diefenbach, michael a; tercyak, kenneth p title: introduction to the special series: translating behavioral medicine research to prevent and control the spread of covid- date: - - journal: transl behav med doi: . /tbm/ibaa sha: doc_id: cord_uid: luk cme nan introduction to the special series: translating behavioral medicine research to prevent and control the spread of covid- alan m. delamater, suzanne m. miller, deborah j. bowen, michael a. diefenbach, kenneth p. tercyak we know how important motivation and protective actions are to people's health and well-being. but just in case that lesson has been dulled, the global coronavirus pandemic serves as a sharp reminder. consider the most often-cited refrain for preventing the spread of this devastating disease: wash your hands, wear a mask, stand feet apart, and do not congregate in large groups of people. soon, hopefully, we will add a fifth health behavior to the list: get vaccinated. drawing from the rich and deep traditions of the field of behavioral medicine, and translating what is known to what remains largely unknown about the coronavirus, behavioral medicine can offer a roadmap to researchers, clinicians, and policymakers to accelerate the tempo of those discoveries and help keep the public safe. consider recent appeals from leaders of very large-scale clinical trials that are essential to developing and testing the safety and efficacy of vaccines against covid- . these will require many tens of thousands of individuals, including those historically underrepresented in biomedical research, to volunteer. can u.s. society overcome its fierce independence to now think and act more collectively for the common good? will we, as individuals, demonstrate solidarity with one another, and proverbially and literally roll-up our sleeves and take a shot in the arm? let's hope so. we have reason to believe that we can and will undertake a move toward more collective action. in times of distress, human nature drives us toward each other. how can we reconcile this need with the need for social distancing? after many natural and man-made disasters, history shows us that people come together. the images we sometimes see on our screens of others behaving in ways that subvert the common good can be counteracted by other, better, exemplars of collective behavior: hand washers, mask wearers, and social distancers. despite the many challenges, often political, behavioral medicine has the tools to empower individuals and society to change behavior and adhere to public health policy guidance. shockingly, what we now have is a behavioral adherence problem on a grand societal scale. as clinician scientists and public health practitioners, we rely on our long-term evidence to guide the development and evaluation of risk communication messages as a key channel to address adherence to health recommendations. behavioral medicine must continue to translate, disseminate, and implement what we know to other constituencies, including politicians, providers, and policymakers who are confronting behavioral nonadherence on an unprecedented level, particularly in certain regions of the usa. based on the evidence and theories of health behavior change accumulated over many decades of research, together we can help provide messages to individuals that do not create fear but also do not create complacency. behavioral science can help providers, practitioners, policymakers, and community advocates recognize that this global pandemic is an extraordinary stressor and health threat. a substantial body of research shows that not all will cope during crises the same way. some (aka "monitors") attend to the threat, magnify it, and are more likely to adhere to guidelines. however, they suffer most in the sense that they may overexpose themselves to threatening information and viral rumination. others (aka "blunters") deny the threat, feel more invulnerable, and may be less likely to adhere to public health directives. other factors, of course, influence these outcomes as well. foremost among them is the need for leadership at the national level, providing consistent messaging about the nature of this pandemic and the public health solutions required, as well as skillful and ubiquitous use of the media in its many and varied forms to communicate those messages. ultimately, these approaches must be guided by the best science and appropriate and transparent use of the data obtained to monitor overall public health, identify cases to provide best treatment, conduct contact tracing, and isolate as needed. unfortunately, the usa has not fared well so far in implementing effective strategies to manage this pandemic. what we have seen instead is the lack of a coordinated national strategy, inconsistent messaging, minimal use of the media, inefficient systems of testing, and published online: september a preference for political spin in place of objective scientific facts and leadership from public health experts. our field's knowledge base of strategies to prevent and control covid- is growing rapidly, and we anticipate that new scientific findings and evidence-based reviews will continue to guide us in the work we do to combat this pandemic. the previous issue of translational behavioral medicine was headed by an editorial concerning the importance of social support in coping with pandemic stress [ ] , as well as a commentary providing recommendations for covid- -related research and policy, particularly as it pertains to underserved populations [ ] . moving forward, translational behavioral medicine is offering an ongoing, special series of papers that have been curated specifically for our readership and submitted in direct response to the growing crisis. within the pages of these articles, you will find empirical research and commentaries at the interface of behavioral medicine and the novel coronavirus. we are focusing on editorials and commentaries, as well as empirical research addressing multiple components of this health crisis, including behavioral and psychosocial risk and resilience factors across the lifespan for various health conditions and populations. the current issue includes six papers addressing diverse topics related to the pandemic, including health care of youth with diabetes, pain management, physical activity and fitness apps, conspiracy beliefs, and intentions to engage in preventive behaviors, as well as a discussion of social and behavioral research opportunities at the national institutes of health. we expect that these papers will be of value to you now and in the time to come as we continue to conduct translational research aimed at improving the delivery of behavioral health care and care of the population. as part of this rapid response initiative, we seek to lead the dialogue so that the field can have a more informed evidence base of the responses of disadvantaged communities to covid and address changes that are desperately needed to the structural and interpersonal systems that promote racism and other forms of disempowerment. for these, we must prioritize changes in policy that move away from the idea of disadvantage and embrace health equity. for example, the alignment of health insurance to employment is a problem during times of high unemployment. expanding state-based insurance systems and considering other models of providing health insurance to disadvantaged groups may help to alter the structures that maintain ill health among minority populations and is a necessary step in changes we could make to improve population health in general and during covid. we look forward to seeing more work addressing these issues. controlling the covid- pandemic surely requires both policy-level intervention and individual behavior change alike. the costs and risks of not doing so are too great. ultimately, this is a litmus test of our field's ability to lead on issues such as health messaging and communication and adherence promotion, especially over time. we anticipate that another major issue will soon face us after the development of a safe and effective vaccine-reluctance of many to take the vaccine based on fear and faulty beliefs. we are counting on you, and all of us, to work together to help solve this for the betterment of all of society. besides moving the field forward and translating findings to promote societal health, we must also look to advocacy and health policy research in these extraordinary times. covid- , stress, trauma, and peer support-observations from the field addressing inequities in covid- morbidity and mortality: research and policy recommendations conflict of interest: the authors have no conflicts of interest to declare. key: cord- - mh mh authors: pratt, r. j.; pellowe, c. m.; wilson, j. a.; loveday, h. p.; harper, p. j.; jones, s.r.l.j.; mcdougall, c.; wilcox, m. h. title: epic : national evidence-based guidelines for preventing healthcare-associated infections in nhs hospitals in england date: - - journal: journal of hospital infection doi: . /s - ( ) - sha: doc_id: cord_uid: mh mh executive summary national evidence-based guidelines for preventing healthcare-associated infections (hcai) in national health service (nhs) hospitals in england were commissioned by the department of health (dh) and developed during - by a nurse-led multi-professional team of researchers and specialist clinicians. following extensive consultation, they were published in january . these guidelines describe the precautions healthcare workers should take in three areas: standard principles for preventing hcai, which include hospital environmental hygiene, hand hygiene, the use of personal protective equipment, and the safe use and disposal of sharps; preventing infections associated with the use of short-term indwelling urethral catheters; and preventing infections associated with central venous catheters. the evidence for these guidelines was identified by multiple systematic reviews of experimental and non-experimental research and expert opinion as reflected in systematically identified professional, national and international guidelines, which were formally assessed by a validated appraisal process. in , we developed complementary national guidelines for preventing hcai in primary and community care on behalf of the national collaborating centre for nursing and supportive care (national institute for healthand clinical excellence). a cardinal feature of evidence-based guidelines is that they are subject to timely review in order that new research evidence and technological advances can be identified, appraised and, if shown to be effective in preventing hcai, incorporated into amended guidelines. periodically updating the evidence base and guideline recommendations is essential in order to maintain their validity and authority. consequently, the dh commissioned a review of new evidence published following the last systematic reviews. we have now updated the evidence base for making infection prevention and control recommendations. a critical assessment of the updated evidence indicated that the original epic guidelines published in remain robust, relevant and appropriate but that adjustments need to be made to some guideline recommendations following a synopsis of the evidence underpinning the guidelines. these updated national guidelines (epic ) provide comprehensive recommendations for preventing hcai in hospitals and other acute care settings based on the best currently available evidence. because this is not always the best possible evidence, we have included a suggested agenda for further research in each section of the guidelines. national evidence-based guidelines are broad principles of best practice which need to be integrated into local practice guidelines. to monitor implementation, we have suggested key audit criteria for each section of recommendations. clinically effective infection prevention and control practice is an essential feature of protecting patients. by incorporating these guidelines into routine daily clinical practice, patient safety can be enhanced and the risk of patients acquiring an infection during episodes of healthcare in nhs hospitals in england can be minimised. we would like to acknowledge the assistance we received from the liverpool reviews and implementation group (university of liverpool) who shared with us data from their health technology assessment focused on the clinical and cost effectiveness of central venous catheters treated with antimicrobial agents in preventing bloodstream infections. we are also indebted to the infection control nurses association and the hospital infection society for their input into the s r.j. pratt et al. made to some guideline recommendations following a synopsis of the evidence underpinning the guidelines. these updated national guidelines (epic ) provide comprehensive recommendations for preventing hcai in hospitals and other acute care settings based on the best currently available evidence. because this is not always the best possible evidence, we have included a suggested agenda for further research in each section of the guidelines. national evidence-based guidelines are broad principles of best practice which need to be integrated into local practice guidelines. to monitor implementation, we have suggested key audit criteria for each section of recommendations. clinically effective infection prevention and control practice is an essential feature of protecting patients. by incorporating these guidelines into routine daily clinical practice, patient safety can be enhanced and the risk of patients acquiring an infection during episodes of healthcare in nhs hospitals in england can be minimised. standard principles for preventing healthcareassociated infections in hospital and other acute care settings this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. all recommendations are endorsed equally and none is regarded as optional. these recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. this guidance on infection control precautions should be applied by all healthcare practitioners to the care of every patient. job descriptions should reflect this and annual appraisal evidence should be available to support continuing engagement of each member of staff. the recommendations are divided into four distinct interventions: . hospital environmental hygiene; . hand hygiene; . the use of personal protective equipment; and . the safe use and disposal of sharps. these guidelines do not address the additional infection control requirements of specialist settings, such as the operating department. hospital environmental hygiene sp the hospital environment must be visibly class c clean, free from dust and soilage and acceptable to patients, their visitors and staff. guidelines for preventing infections associated with the use of short-term indwelling urethral catheters this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. all recommendations are endorsed equally and none is regarded as optional. these recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. these guidelines apply to adults and children aged year and older and should be read in conjunction with the guidance on standard principles. the recommendations are divided into five distinct interventions: this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. all recommendations are endorsed equally and none is regarded as optional. these recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. these guidelines apply to adults and children aged one year and older and should be read in conjunction with the guidance on standard principles. the recommendations are divided into distinct interventions: . education of healthcare workers and patients; . general asepsis; . selection of catheter type; . selection of catheter insertion site; . maximal sterile barrier precautions during catheter insertion; . cutaneous antisepsis; . catheter and catheter site care; . catheter replacement strategies; and . general principles for catheter management. an evidence review in indicated the necessity to amend and update some of the original epic guideline recommendations to ensure that they continue to reflect new and emerging evidence, remain relevant to infection control and prevention practice and enjoy the confidence of practitioners and patients. , additional updating systematic reviews were conducted in and the original epic guidelines have now been revised. they are referred to in this publication as the epic infection prevention guidelines, which now replace the original guidelines. what are national evidence-based guidelines? these are systematically developed broad statements (principles) of good practice. they are driven by practice need, based on evidence and subject to multi-professional debate, timely and frequent review, and modification. national guidelines are intended to inform the development of detailed operational protocols at local level and can be used to ensure that these incorporate the most important principles for preventing hcai in nhs hospitals and other acute care health services. why do we need national guidelines for preventing healthcare-associated infections? during the past two decades, hcai have become a significant threat to patient safety. the technological advances made in the treatment of many diseases and disorders are often undermined by the transmission of infections within healthcare settings, particularly those caused by antimicrobial-resistant strains of disease-causing microorganisms that are now endemic in many healthcare environments. the financial and personal cost of these infections, in terms of the economic consequences to the nhs and the physical, social and psychological costs to patients and their relatives, have increased both government and public awareness of the risks associated with healthcare interventions, especially that of acquiring a new infection. although not all hcai can be prevented, many can. clinical effectiveness, i.e., using prevention measures that are based on reliable evidence of efficacy, is a core component of an effective strategy designed to protect patients from the risk of infection. what is the purpose of the guidelines? these guidelines describe clinically effective measures that are used by healthcare workers for preventing infections in hospital and other acute care health services. what is the scope of the guidelines? three sets of guidelines were originally developed and have now been updated. they include: • standard infection control principles include best practice recommendations for hospital environmental hygiene, effective hand hygiene, the appropriate use of personal protective equipment, and the safe use and disposal of sharps; • guidelines for preventing infections associated with the use of short-term indwelling urethral catheters; and • guidelines for preventing infections associated with the use of central venous access devices. what is the evidence for these guidelines? the evidence for these guidelines was identified by multiple systematic reviews of experimental and non-experimental research. in addition, evidence from expert opinion as reflected in systematically identified professional, national and international guidelines was considered following formal assessment using a validated appraisal process. , all evidence was critically appraised for its methodological rigour and clinical practice applicability and the best available evidence influenced the guideline recommendations. who developed these guidelines? the epic guidelines were developed by a nurseled team of researchers, senior infection control nurses and a director of microbiology and infection prevention and control in a large nhs teaching hospital trust (see . ). who are these guidelines for? these guidelines can be appropriately adapted and used by all hospital practitioners. they will inform the development of more detailed local protocols and ensure that important standard principles for infection prevention are incorporated. consequently, they are aimed at hospital managers, members of hospital infection control teams, and individual health care practitioners. at an individual level, they are intended to influence the quality and clinical effectiveness of infection prevention decision-making. the dissemination of these guidelines also help patients understand the standard infection prevention precautions recommended to protect them from hcai. how are these guidelines structured? each set of guidelines follows an identical format, which consists of: • a resume of the systematic review process; • the intervention heading; • a headline statement describing the key issues being addressed; • a synthesis of the related evidence; • an economic opinion, where appropriate; • guideline recommendation(s) classified according to the strength of the underpinning evidence. finally, at the end of each section there is a description of areas for further research and suggested audit criteria. all evidence is referenced in section . how frequently are the guidelines reviewed and updated? a cardinal feature of evidence-based guidelines is that they are subject to timely review in order that new research evidence and technological advances can be identified, appraised and, if shown to be effective in preventing hcai, incorporated into amended guidelines. the evidence base for these guidelines will be reviewed in two years ( ) and the guidelines will be updated approximately four years after publication ( ). how can these guidelines be used to improve your clinical effectiveness? in addition to informing the development of detailed local operational protocols, these guidelines can be used as a benchmark for determining appropriate infection prevention decisions and, as part of reflective practice, to assess clinical effectiveness. they also provide a baseline for clinical audit, evaluation and education, and facilitate ongoing quality improvements. how much will it cost to implement these guidelines? significant additional costs are not anticipated in implementing these guidelines. however, where current equipment or resources do not facilitate the implementation of the guidelines, or where staff levels of adherence to current guidance are poor, there may be an associated increase in costs. given the social and economic costs of hcai, the consequences associated with not implementing these guidelines would be unacceptable to both patients and health care professionals. these guidelines have been subject to extensive external consultation with key stakeholders, including royal colleges, professional societies and organisations, including patients, and trades unions (appendix a. ). the guidelines were developed using a systematic review process (appendix a. ). in each set of guidelines a resume of the relevant guideline development methodology is provided. electronic databases were searched for national and international guidelines and research studies published during the period january to august . a two-stage search process was used. for each set of epic guidelines, an electronic search was conducted for systematic reviews of randomised controlled trials and current national and international guidelines. the following data bases were searched: • cochrane library; • national guideline clearinghouse; • national electronic library of health; • national institute for health and clinical excellence. guidelines were retrieved and subjected to critical appraisal using the agree instrument, an evaluation method used in europe for assessing the methodological quality of clinical practice guidelines. following appraisal, accepted guidelines were included as part of the evidence base supporting guideline development. they were also used to verify professional consensus and in some instances, as the primary source of evidence. stage : systematic search for additional evidence review questions for the systematic reviews of the literature were then developed for each set of epic guidelines following recommendations from expert advisors. searches were constructed using relevant mesh (medical subject headings) and free-text terms. on completion of the main search, an economic filter was applied. the following databases were searched: • cumulated index of nursing and allied health literature; • embase; • the cochrane library. abstract review -identifying studies for appraisal search results were downloaded into a reference manager™ database and titles and abstracts printed for preliminary review. reviewers identified and retrieved all studies where the title or abstract: addressed one or more of the review questions; identified primary research or systematically conducted secondary research; indicated a theoretical/clinical/ in use study. no research designs were specifically excluded but wherever possible, in use rather than in vitro studies were retrieved. where no abstract was available and the title indicated one or more of the above criteria, the study was retrieved. due to the limited resources available for this review, foreign language studies were not reviewed. all full-text studies retrieved were independently assessed by two experienced reviewers who identified those studies meeting the above inclusion criteria for critical appraisal. included studies were appraised using an adapted data extraction process based on systems developed by the scottish intercollegiate guideline network for study quality assessment. due to the limited resources available for this review, studies were not double-blind appraised. however, all studies were appraised and data extracted by one experienced reviewer and then checked by a second experienced reviewer. any disagreement between reviewers was resolved through discussion. evidence tables were constructed from the quality assessments and the studies summarised in the evidence reports. the evidence was classified using methods adopted by the national institute for health and clinical excellence (nice) from the scottish intercollegiate guideline network (sign) ( table ) . , this system differs from that used in the previous epic and nice infection prevention guidelines. , the evidence tables and reports were presented to the advisors for discussion. at this stage, expert advice derived from seminal works and appraised national and international guidelines were considered. following extensive discussion the guidelines were drafted. factors influencing the guideline recommendations included: • the nature of the evidence; • the applicability of the evidence to practice; • costs and knowledge of healthcare systems. the classification scheme adapted by nice from sign was used to define the strength of recommendation (table ). , the complete series of evidence tables are posted on the epic website at: [http://www.epic. tvu.ac.uk]. type of evidence ++ high-quality meta-analyses, systematic reviews of randomised controlled trials (rct), or rct with a very low risk of bias + well-conducted meta-analyses, systematic reviews of rct, or rct with a low risk of bias -meta-analyses, systematic reviews of rct, or rct with a high risk of bias* ++ high-quality systematic reviews of case-control or cohort studies high-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal + well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal -case-control or cohort studies with a high risk of confounding bias, or chance and a significant risk that the relationship is not causal* non-analytic studies (for example, case reports, case series) expert opinion, formal consensus *studies with a level of evidence ' -' should not be used as a basis for making a recommendation these guidelines do not address the additional infection control requirements of specialist settings, such as the operating department or for outbreak situations. we have previously described the systematic review process in section . . for detailed descriptions of previous systematic reviews which have contributed to the evidence base underpinning these guidelines, readers should consult the original guidelines, the guidelines for the prevention of health-care associated infections in primary and community care and our interim report in on changes in the evidence base. search questions were developed from advice received from our specialist advisors and the results of the searches are found in section . . the process outlined in section . refers only to the most recent systematic review of the literature undertaken in . following our reviews, guidelines were drafted which described recommendations within the below intervention categories: . hospital environmental hygiene; . hand hygiene; . personal protective equipment; and . safe use and disposal of sharps. good hospital hygiene is an integral and important component of a strategy for preventing healthcare-associated infections in hospitals this section discusses the evidence upon which recommendations for hospital environmental hygiene are based. hospital environmental hygiene encompasses a wide range of routine activities including: cleaning and decontamination; laundry and housekeeping; safe collection and disposal of general and clinical waste; and kitchen and food hygiene. guidelines are provided here for: • cleaning the general hospital environment; • cleaning items of shared equipment; and • education and training of staff. our initial systematic review concluded that there was little research evidence of an acceptable quality upon which to base guidance related to the maintenance of hospital environmental hygiene. however, there was a body of clinical evidence, derived from case reports and outbreak investigations, which suggested an association between poor environmental hygiene and the transmission of microorganisms causing healthcare-associated infections in hospital. , attention had been drawn to perceived falling standards in the cleanliness of hospitals since the introduction of compulsory comprehensive tendering and the internal market. this concern was addressed by the infection control nurses association and the association of domestic managers, resulting in the adoption and publication by the department of health of quality standards for hospital cleanliness , and more recently the nhs healthcare cleaning manual. in addition, existing regulations, - specialist advice, , and clinical governance guidance, all provide a framework within which hospital environmental hygiene can be improved and monitored. the nhs code of practice on the prevention and control of healthcare associated infection came into effect in october . the purpose of this code of practice is to help nhs bodies plan and implement strategies for the prevention and control of hcai. it sets out criteria by which managers of nhs organisations and other healthcare providers should ensure that patients are cared for in a clean environment, where the risk of hcai is kept as low as possible. failure to comply with the code may result in an improvement notice being issued or other measures. there is new evidence highlighting that the hospital environment can become contaminated with microorganisms responsible for hcai. [ ] [ ] [ ] [ ] [ ] [ ] transmission of microorganisms from the environment to patients may occur through direct contact with contaminated equipment, or indirectly as a result of touching by hands. meticillin epic : guidelines for preventing healthcare-associated infections in nhs hospitals s , and sink taps, , , and sites where dust is allowed to accumulate. , however, whilst the presence of the same strain of microorganism in the environment as those infecting/colonising patients demonstrates that the environment becomes contaminated with microorganisms from patients, it does not provide confirmation that the environment is responsible for contamination of patients. evidence suggesting that contamination of the environment is responsible for the transmission of hcai is therefore not conclusive. nevertheless, the evidence that pathogens responsible for hcai can be widely found in the hospital environment and hence readily acquired on hands by touching surfaces, does demonstrate the importance of decontaminating hands before every patient contact. many microorganisms recovered from the hospital environment do not cause hcai. cleaning will not completely eliminate microorganisms from environmental surfaces and reductions in their numbers will be transient. there is some evidence that improved cleaning regimens are associated with the control of outbreaks of hcai. in one study, the control of an outbreak of an epidemic strain of mrsa was linked with increased cleaning hours and an emphasis on the removal of dust. however, often a range of interventions are introduced in order to control an outbreak and it is difficult to clearly distinguish the effect of a single component such as cleaning. some evidence suggests that routine cleaning methods may not be sufficient to eliminate surface contamination with mrsa. , disinfectants have been recommended for cleaning of the hospital environment but a systematic review failed to confirm a link between disinfection and the prevention of hcai, though contamination of detergent and inadequate disinfection strength could have been an important confounder. the use of hypochlorite for cleaning has been associated with a reduction in incidence of clostridium difficile infection in one study but this was in the absence of a detectable change in environmental contamination when either detergent or hypochlorite was used. in laboratory tests a combination of cleaning with detergent followed by hypochlorite was required to consistently eliminate norovirus from surfaces and prevent cross contamination. dusting and cleaning using detergent was reported to have no effect on the number of mrsa isolated from the hospital environment, but the organism was virtually eliminated by exposure to hydrogen peroxide vapour. indicators of cleanliness based on levels of microbial or adenosine triphosphate (atp) contamination have been proposed but are based on arbitrary standards of acceptable contamination and do not distinguish between normal environmental flora and pathogens responsible for hcai. , the relationship between these proposed standards and the risk of acquiring infection through contact with the environment have not been established. since cleaning will only have a transient effect on the numbers of microorganisms, regular cleaning of hospital surfaces will not guarantee complete elimination. hand decontamination before every patient contact is therefore required to ensure that pathogens acquired by touch are not transferred to patients. the hospital environment must be visibly class c clean, free from dust and soilage and acceptable to patients, their visitors and staff. shared equipment must be decontaminated after use there is some evidence demonstrating that shared clinical equipment becomes contaminated with pathogens. one study found that more than % of commodes tested were contaminated with clostridium difficile. a systematic review identified a number of studies demonstrating that pathogens can be recovered from a range of noninvasive clinical equipment, including stethoscopes, lifting equipment, and ultrasound probes. none of these studies demonstrated a link between the contamination and infection in a patient. shared clinical equipment used to deliver care in the clinical environment comes into contact with intact skin and is therefore unlikely to introduce infection. however it can act as a vehicle by which microorganisms are transferred between patients, which may result in infection. this equipment should therefore be appropriately decontaminated after each use with detergent and water. in some outbreak situations hypochlorite and detergent should be considered. sp shared equipment used in the clinical class d environment must be decontaminated appropriately after each use. hospital hygiene is everybody's business three studies in a systematic review of healthcare workers' knowledge about mrsa and/or frequency of cleaning practices indicated that staff were not utilising appropriate cleaning practices with sufficient frequency to ensure minimisation of mrsa contamination of personal equipment. staff education was lacking on optimal cleaning practices in the clinical areas. knowledge deficits may hinder the application of cleaning practices and monitoring and evaluation was indicated. this is further reinforced by an observational study which noted that lapses in adhering to the cleaning protocol were linked with an increase in environmental contamination with isolates of acinetobacter baumannii. a second systematic review of four cohort studies comparing the use of detergents and disinfectants on microbial contaminated hospital environmental surfaces suggested that a lack of effectiveness was, in many instances due inadequate strengths of disinfectants, probably resulting from a lack of knowledge. the following section provides the evidence for recommendations concerning hand hygiene practice. the difficulty in designing and conducting robust, ethical, randomised controlled trials in the field of hand hygiene means that recommendations in these areas are based on evidence from non-randomised controlled trials (nrct), quasiexperimental studies and expert opinion derived from systematically retrieved and appraised professional, national and international guidelines. the areas discussed include: • assessment of the need to decontaminate hands; • the efficacy of hand decontamination agents and preparations; • the rationale for choice of hand decontamination practice; • technique for hand decontamination; • care required to protect hands from the adverse effects of hand decontamination practice; • promoting adherence to hand hygiene guidelines. why is hand decontamination crucial to the prevention of healthcare-associated infection? cross-transmission, the transfer of microorganisms between humans, which occurs directly via hands, or indirectly via an environmental source, such as a commode or wash-bowl, occurs all the time in hospitals. it is the antecedent factor to crossinfection that can result in severe clinical outcomes. overviews of epidemiological evidence conclude that hand-mediated cross-transmission is a major contributing factor in the current infection threats to hospital in-patients. crosstransmission via hands has been identified as contributing to hospitals outbreaks involving both meticillin-sensitive and meticillin-resistant staphylococcus aureus (mrsa/mssa), multiresistant gram-negative microorganisms, such as acinetobacter spp and vancomycin resistant enterococci (vre). hand-mediated cross-transmission from resident flora (microorganisms that are present on the hands most of the time) and transient flora (microorganisms that are acquired during healthcare activity and without hand hygiene can be deposited directly on to vulnerable patients) presents a direct clinical threat to patients. when these microorganisms are cross transmitted onto susceptible sites, such as surgical wounds, endo-tracheal tubes during pulmonary ventilation, intravascular cannulation sites, enteral feeding systems or urinary catheter drainage systems, etc., serious lifethreatening infections can arise. even the crosstransmission to non-vulnerable sites can still leave a patient colonised with more pathogenic and resistant hospital microorganisms which may, if opportunity arises, result in a healthcare associated infection at sometime in the future. epic : guidelines for preventing healthcare-associated infections in nhs hospitals s current evidence-based guidelines conclude that in both outbreak and non-outbreak situations contaminated hands are responsible for crosstransmission of microorganisms and that effective and effective hand decontamination can significantly reduce both cross-transmission and crossinfection rates for the majority of hcai in all healthcare settings. a recent case control study, conducted during an outbreak of klebsiella pneumoniae in a neonatal intensive care unit, demonstrated an association between being cared for by a nurse with positive hand cultures for the outbreak strain and infants developing infection or colonisation. descriptive studies of the dynamics of bacterial hand contamination demonstrate an association between patient care activities that involve direct patient contact and hand contamination. , in an observational study of hand contamination during routine patient care in a large teaching hospital, high levels of hand contamination were associated with direct patient contact, respiratory care and handling body fluids. a further descriptive study of healthcare workers' hand contamination during routine neonatal care demonstrated that hands become increasingly contaminated and that gloves do not fully protect healthcare workers' hands from becoming contaminated. the association between hand decontamination and reductions in infection have been confirmed by two additional clinically-based trials , and two descriptive studies. , a nrct introducing the use of alcohol-based hand gel to a long term elderly care facility, demonstrated a reduction of % in hcai over a period of months when compared with the control unit. a further nrct, demonstrated a % reduction in respiratory illness in the post-intervention period following the introduction of a hand washing programme. one descriptive study conducted over a four year period during which alcohol-based handrub was introduced for routine hand hygiene demonstrated a reduction in hcai from . % to . %. a second study that compared rates of hcai caused by mrsa, vancomycin-resistant enterococci (vre) and clostridium difficile (c. difficile) in the three years prior to the introduction of alcohol-based handrub showed reductions of % in mrsa and % decrease in vre. rates of c. difficile remained unchanged throughout the intervention period. current national and international guidance consistently identify that effective hand decontamination results in significant reductions in the carriage of potential pathogens on the hands and logically decreases the incidence of preventable hcai leading to a reduction in patient morbidity and mortality. , when must you decontaminate your hands in relation to patient care? decontamination refers to a process for the physical removal of blood, body fluids, and the removal or destruction of microorganisms from the hands, current national and international guidance suggests that in deciding when it is necessary to decontaminate hands prior to patient contact, four key factors need to be considered: , • the level of the anticipated contact with patients or objects; • the extent of the contamination that may occur with that contact; • the patient care activities being performed; • the susceptibility of the patient. patients are put at risk of developing a hcai when informal carers or healthcare workers caring for them have contaminated hands. hands must be decontaminated before every episode of care that involves direct contact with patients' skin, their food, invasive devices or dressings. current expert opinion recommends that hands need to be decontaminated after completing an episode of patient care and following the removal of gloves to minimise cross contamination of the environment. , hands must be decontaminated class c immediately before each and every episode of direct patient contact/care and after any activity or contact that potentially results in hands becoming contaminated. is any one hand cleaning preparation better than another? current national and international guidelines , consider the effectiveness of various preparations for the decontamination of hands using liquid soap and water, antiseptic handwash agents, and alcohol-based handrubs. overall there is no compelling evidence to favour the general use of antiseptic handwashing agents over soap, or one antiseptic agent over another. , systematic reviews conducted to underpin guidelines for community and primary care and update the epic guidance , identified nineteen studies comparing hand hygiene preparations including alcohol-based handrubs and gels, antiseptic hand washes and liquid soap. five randomised controlled trials (rct) were conducted in clinical settings and compared the use of alcohol-based preparations with other agents. [ ] [ ] [ ] [ ] [ ] four rcts demonstrated alcohol-based preparations to be a more effective hand hygiene agent than non-medicated soap and antiseptic handwashing agents, [ ] [ ] [ ] [ ] while a fifth study found no statistical difference between the use of alcoholbased preparations and antiseptic soap. a clinical crossover trial conducted over months within a neonatal intensive care unit demonstrated no statistical difference between infection rates during the hand washing and handrub phases of the trial. three clinically based, quasi-experimental studies [ ] [ ] [ ] and nine controlled laboratory experiments - also demonstrated an association between reductions in microbiological flora and the use of alcohol-based preparations. these studies underpin a growing trend to adopt the use of alcohol-based handrubs and gels in clinical practice. however, two of the above laboratory studies highlight the need for continued evaluation of the use of alcohol-based handrubs within the clinical environment to ensure staff adherence to guidelines and effective hand decontamination. , the first study, using european union (eu) reference standards raises the possibility that alcohol-based gels may not be as effective as handrubs for short durations of use. the second laboratory study, comparing different hand hygiene agents used for a 'clinically realistic' second hand hygiene episode, suggests that some alcohol-based handrubs may lose efficacy after consecutive uses. one clinically-based quasiexperimental study compared the use of % chlorhexidine gluconate and % triclosan antiseptic handwash preparations in reducing mrsa hand carriage in a specialist surgical ward. both preparations effectively reduced total hand bacterial counts but % triclosan was more effective at eliminating mrsa. choice of decontamination: is it always necessary to wash hands to achieve decontamination? choosing the method of decontaminating hands will depend upon the assessment of what is appropriate for the episode of care, the available resources, what is practically possible and, to some degree, personal preferences based on the acceptability of preparations or materials. in general, effective handwashing with a liquid soap will remove transient microorganisms and render the hands socially clean. this level of decontamination is sufficient for general social contact and most clinical care activities. , , the use of a liquid soap preparation that contains an antiseptic will reduce both transient micro-organisms and resident flora. , the effective use of alcohol-based handrubs will also successfully remove transient microorganisms and substantially reduce resident microorganisms. however, alcohol is not effective against some microorganisms such as c. difficile, will not remove dirt and organic material and may not be effective in some outbreak situations. , when deciding which hand decontamination preparation to use, the practitioner must consider the need to remove transient and/or resident hand flora. preparations containing certain antiseptics that exert a residual effect on skin flora can be useful in situations where prolonged reduction in microbial flora on the skin is required e.g. surgery and some invasive procedures. they are not normally necessary for everyday clinical practice but may be used in outbreak situations. national and international guidelines suggest that the acceptability of agents and techniques is an essential criterion for the selection of preparations for hand hygiene. , acceptability of preparations is dependent upon the ease with which the preparation can be used in terms of time and access together with their dermatological effects. due to their efficacy and ease of use, alcohol-based handrubs are recommended for routine use and offer a practical and acceptable alternative to handwashing when hands are not grossly soiled. there are no robust economic evaluations of the comparative costs associated with different hand hygiene agents and rates of hcai. in an unpublished study of the potential cost savings associated with a national hand hygiene campaign the cost of a single hcai is estimated at over £ , . the authors hypothesise that even a small reduction in infections through the use of alcoholbased handrubs, would result in a cost saving. hands , the first study proposes that there is an association between effective hand decontamination and the wearing of rings by healthcare staff for clinical care. it suggests that the removal of rings should result in decreased frequency of hand carriage of pathogens before and after the performance of hand hygiene. in a case control study, conducted during an outbreak of klebsiella pneumoniae in a neonatal intensive care unit, investigators suggest an association between being cared for by a nurse who wore false nails and had positive hand cultures for the outbreak strain, and infants developing infection or colonisation. systematic reviews conducted to underpin guidelines for community and primary care and update the epic guidance , identified one rct comparing different durations of handwashing and handrubbing on bacterial reduction that found no significant differences between the two study groups. in addition a laboratory study conducted following a period of clinical observation of hand hygiene technique identified that practitioners on average applied a product for . seconds and concluded that some alcohol-based handrubs become less effective following consecutive hand hygiene episodes. the authors suggest that periodic decontamination of hands, using liquid soap and water, is advisable throughout a shift. two small-scale laboratory studies investigating methods of hand drying were identified. one found no statistically significant differences between the four methods studied and the other suggests that warm air drying, when the hands are not rubbed simultaneously, may be more effective at reducing the numbers of bacteria on the hands following hand washing than the use of paper towels. due to the methodological limitations of the above studies, recommendations continue to be based on existing expert opinion that the duration of hand decontamination, the exposure of all aspects of the hands and wrists to the preparation being used, the use of vigorous rubbing to create friction, thorough rinsing in the case of handwashing, and ensuring that hands are completely dry are key factors in effective hand hygiene and the maintenance of skin integrity. does hand decontamination damage skin? expert opinion concludes that skin damage is generally associated with the detergent base of the preparation and/or poor handwashing technique. however, the frequent use of hand hygiene agents may cause damage to the skin and alter normal hand flora. excoriated hands are associated with increased colonisation of potentially pathogenic microorganisms and increase the risk of infection. , in addition, the irritant and drying effects of hand preparations have been identified as one of the reasons why healthcare practitioners fail to adhere to hand hygiene guidelines. , systematic reviews conducted to underpin guidelines for community and primary care and update the epic guidance , identified ten studies of which four were rct conducted in clinical settings. , , , they compared the use of alcohol-based preparations with liquid soap and water using self-assessment of skin condition by nurses. in these studies a greater level of irritation was associated with the use of soap. three further studies, one clinically-based quasi-experimental study, one descriptive clinical study and one nonclinical experimental study concluded that s r.j. pratt et al. alcohol-based handrubs caused less skin irritation. , , in addition, one longitudinal study of the introduction and subsequent use of alcoholbased handrub over a seven year period observed no reports of irritant and contact dermatitis associated with the use of alcohol-based handrubs. a laboratory study demonstrated a strong relationship between the frequency of handwashing with a chlorhexidine preparation and dermatitis. current national and international guidance suggests that skin care, through the appropriate use of hand lotion or moisturizers added to hand hygiene preparations, is an important factor in maintaining skin integrity, encouraging adherence to hand decontamination practices and assuring the health and safety of healthcare practitioners. how can adherence to hand hygiene guidance be promoted? national and international guidelines emphasise the importance of adherence with hand hygiene guidance and provide an overview of the barriers and factors that impact on hand hygiene compliance. , in a systematic review of studies of interventions to improve hand hygiene compliance reviewers concluded that: • single interventions have a short-term influence on hand hygiene; • reminders have a modest but sustained effect; • feedback increases rates of hand hygiene but must be regular; • near patient alcohol-based preparations improve the frequency with which healthcare workers clean their hands; • multi-faceted approaches have a more marked effect on hand hygiene and rates of hcai. recent observational studies of multimodal interventions involving the introduction of alcohol-based handrubs support findings that the use of near patient alcohol-based handrub is consistently associated with greater compliance by healthcare staff. , [ ] [ ] [ ] [ ] [ ] however, observational studies identify that staff fail to assess risk appropriately and therefore make inappropriate choices in relation to hand hygiene and glove use. [ ] [ ] [ ] [ ] [ ] one study suggests that the use of motivational strategies, for example feedback may be beneficial. there is some evidence from small-scale observational studies that providing patient information and actively involving patients in hand hygiene improvement programmes has a positive effect on hand hygiene compliance. this section discusses the evidence and associated recommendations for the use of personal protective equipment (ppe) by healthcare workers in general care settings and includes the use of aprons, gowns, gloves, eye protection and face masks. where appropriate, in addition to the classification of the evidence underpinning the recommendations, there is an indication of a health and safety (h&s) requirement. infection control dress code -protect your patients and yourself! expert opinion suggests that the primary uses of ppe are to protect staff and reduce opportunities for transmission of microorganisms in hospitals. , , a trend to eliminate the inappropriate wearing of aprons, gowns and masks in general care settings has evolved over the past twenty years due to the absence of evidence that they are effective in preventing hcai. , the decision to use or wear personal protective equipment must be based upon an assessment of epic : guidelines for preventing healthcare-associated infections in nhs hospitals s the level of risk associated with a specific patient care activity or intervention and take account of current health and safety legislation. since the mid- s the use of gloves as an element of ppe has become an every-day part of clinical practice for healthcare workers. expert opinion agrees that there are two main indications for the use of gloves in preventing hcai: , . to protect hands from contamination with organic matter and microorganisms; and . to reduce the risks of transmission of microorganisms to both patients and staff. to glove or not to glove? gloves should not be worn unnecessarily as their prolonged and indiscriminate use may cause adverse reactions and skin sensitivity. , as with all items of ppe the need for gloves and the selection of appropriate materials must be subject to careful assessment of the task to be carried out and its related risks to patients and health care workers. , risk assessment should include consideration of: • who is at risk (whether it is the patient or the healthcare worker) and whether sterile or nonsterile gloves are required; • the potential for exposure to blood, body fluids, secretions and excretions; • contact with non-intact skin or mucous membranes during general care and invasive procedures. gloves must be discarded after each care activity for which they were worn in order to prevent the transmission of microorganisms to other sites in that individual or to other patients. washing gloves rather than changing them is not safe. gloves leak! our previous systematic review provided evidence that gloves used for clinical practice may leak when apparently undamaged. , in terms of leakage, gloves made from natural rubber latex (nrl) performed better than vinyl gloves in laboratory test conditions. revised standards (bsi ) relating to the manufacture of medical gloves for single use have been devised and implemented. [ ] [ ] [ ] these standards require gloves regardless of material to perform to the same standard. expert opinion supports the view that the integrity of gloves cannot be taken for granted and additionally, hands may become contaminated during the removal of gloves. , an additional study provided evidence that vancomycin resistant enterococcus remained on the hands of healthcare workers after the removal of gloves. therefore, the use of gloves as a method of barrier protection reduces the risk of contamination but does not eliminate it and hands are not necessarily clean because gloves have been worn. expert opinion is quite clear about when gloves must be used by healthcare workers in general clinical practice. , having decided that gloves should be used for a healthcare activity, the healthcare worker must make a choice between the use of: • sterile or non-sterile gloves, based on contact with susceptible sites or clinical devices; • surgical or examination gloves, based on the aspect of care or treatment to be undertaken. nhs trusts need to provide gloves that conform to european standard, and which are acceptable to health care practitioners. , gloves are available in a variety of materials, the most common being natural rubber latex (nrl) and synthetic materials. nrl remains the material of choice due to its efficacy in protecting against bloodborne viruses and properties that enable the wearer to maintain dexterity. , the problem of patient or health care practitioner sensitivity to nrl proteins must be considered when deciding on glove materials. synthetic materials are generally more expensive than nrl and due to certain properties may not be suitable for all purposes. nitrile gloves have the same chemical range as nrl and may also lead to sensitivity problems. vinyl gloves made to european standards provide the same level of protection as nrl. polythene gloves are not suitable for clinical use due to their permeability and tendency to damage easily. a study comparing the performance of nitrile, latex, copolymer and vinyl gloves under stressed and unstressed conditions found that nitrile gloves had the lowest failure rate, adding further evidence that nitrile gloves are a suitable alternative to latex, providing there are no sensitivity issues. importantly, the study noted variation in performance of the same type of glove produced by different manufacturers and propose a test and rating system to assist healthcare workers. we identified four small scale observational studies that investigated the potential for uniforms to become contaminated during clinical care. however none of these studies established an association between contaminated uniforms and hcai. [ ] [ ] [ ] a further study demonstrated high levels of contamination of gowns, gloves and stethoscopes with vancomycin-resistant enterococci (vre) following examination of patients known to be infected. a systematic review of eight studies reporting outcomes of , babies to assess the effects of wearing and gowning by attendants and visitors in newborn nurseries found no evidence to suggest that over gowns are effective in reducing mortality, clinical infection or bacterial colonisation in infants admitted to newborn nurseries. one quasi-experimental study investigated the use of gowns and gloves as opposed to gloves only in preventing the acquisition of vre in a medical intensive care unit setting. a further prospective observational study investigated the use of a similar intervention in a medical intensive care unit. these studies suggest that the use of gloves and gowns may minimise the transmission of vre when colonisation pressure is high. national and international guidelines recommend that protective clothing should be worn by all healthcare workers when close contact with the patient, materials or equipment may lead to contamination of uniforms or other clothing with microorganisms or, when there is a risk of contamination with blood, body fluids, secretions, or excretions (with the exception of perspiration). , , disposable plastic aprons are recommended for general clinical use. , , however, unused aprons need to be stored in an appropriate area away from potential contamination. full body gowns need only be used where there is the possibility of extensive splashing of blood, body fluids, secretions or excretions and should be fluid repellent. , , waste. non-disposable protective clothing should be sent for laundering. when is a facemask, respiratory protection and eye protection necessary? healthcare workers (and sometimes patients) may use standard surgical facemasks to prevent respiratory droplets from the mouth and nose being expelled into the environment. facemasks are also used, often in conjunction with eye protection, to protect the mucous membranes of the wearer from exposure to blood and/or body fluids when splashing may occur. our previous systematic review failed to reveal any robust experimental studies that demonstrated that healthcare workers wearing surgical facemasks protected patients from hcai during routine ward procedures, such as wound dressing or invasive medical procedures. facemasks are also used to protect the wearer from inhaling minute airborne respiratory particles. as surgical facemasks are not effective in filtering out such small respiratory particles, specialised respiratory protective equipment is recommended for the care of patients with certain respiratory diseases, e.g. active multiple drugresistant pulmonary tuberculosis, severe acute respiratory syndrome (sars), pandemic influenza. the filtration efficiency of these masks (sometimes called 'respirators') will protect the wearer from inhaling small respiratory particles but to be effective, they must fit closely to the face to minimise leakage around the mask. , , although the advice to use particulate filter masks is based on expert opinion, there is evidence from one study that staff exposed to patients with sars acquired the infection when they did not use particulate filter masks. another study demonstrated a lack of knowledge about guidance on using particulate respirator masks among staff caring for patients with sars and suggests that focused training on the use of personal protective equipment and the transmission risk of sars is required. our previous systematic review indicated that different protective eyewear offered protection against physical splashing of infected substances into the eyes (although not on all occasions) but that compliance was poor. expert opinion recommends that face and eye protection reduce the risk of occupational exposure of healthcare workers to splashes of blood, body fluids, secretion or excretions. this section discusses the evidence and associated recommendations for the safe use and disposal of sharps in general care settings and include minimising the risks associated with sharps use and disposal, and the use of needle protection devices. where appropriate, in addition to the classification of evidence underpinning the recommendations, there is an indication of a health and safety (h&s) legislation requirement. the safe handling and disposal of needles and other sharp instruments forms part of an overall strategy of clinical waste disposal to protect staff, patients and visitors from exposure to bloodborne pathogens. the report draws attention to the need for nhs trusts to provide local protocols and information on the risk of bloodborne viruses in the work place and to ensure that healthcare workers are adequately trained on how to prevent injuries. the average risk of transmission of bloodborne viruses following a single percutaneous exposure from an infected person, in the absence of appropriate post exposure prophylaxis has been estimated to be: , • hepatitis b virus (hbv) . % ( in ) national and international guidelines, are consistent in their recommendations for the safe use and disposal of sharp instruments and needles. , [ ] [ ] [ ] as with many infection prevention and control policies, the assessment and management of the risks associated with the use of sharps is paramount and safe systems of work and engineering controls must be in place to minimise any identified risks, e.g., positioning the sharps bin as close as possible to the site of the intended clinical procedure. any healthcare worker experiencing an occupational exposure to blood or body fluids needs to be assessed for the potential risk of infection by a specialist practitioner, e.g., physician, occupational health nurse and offered testing, immunisation and postexposure prophylaxis if appropriate. avoiding sharps injuries is everybody's responsibility all healthcare workers must be aware of their responsibility in avoiding needlestick injuries. this should be a part of induction programmes for new staff and on-going in-service education. a national blended e-learning programme on preventing hcai is available for all healthcare workers. the incidence of sharps injuries has led to the development of needlestick-prevention devices in many different product groups. they are designed to minimise the risk of operator injury during needle use as well as so-called "downstream" injuries that occur after disposal, often involving the housekeeping or portering staff responsible for the collection of sharps disposal units. our previous systematic reviews , failed to identify any convincing evidence that needlestickprevention devices were responsible for any significant impact on injury rates. this was primarily due to the lack of well-designed, controlled intervention studies. more recent studies have shown significant reductions in injuries associated with the use of safety devices in cannulation, , phlebotomy - and injections. it would seem to be logical that where needlefree or other protective devices are used, there should be a resulting reduction in sharps injuries. a review of needlestick injuries in scotland suggested that % of injuries would 'probably' or 'definitely' have been prevented if a safety device had been used. however, some studies identify a range of barriers to the expected reduction in injuries, including staff resistance to using new devices, complexity of device operation or improper use, and poor training. a comprehensive report and product review conducted in the united states of america (usa) provides background information and guidance on the need for and use of needlestick-prevention devices but also gives advice on establishing and evaluating a epic : guidelines for preventing healthcare-associated infections in nhs hospitals s sharps injury prevention program. the report identifies that all devices have limitations in relation to cost, applicability and/or effectiveness. some of the devices available are more expensive than standard devices, may not be compatible with existing equipment, and may be associated with an increase in bloodstream infection rates. in the usa, the occupational safety health administration (osha) and the national institute for occupational safety and health (niosh) suggest that a thorough evaluation of any device is essential before purchasing decisions are made. , similarly in the united kingdom, the national health service purchasing and supply agency identifies that meaningful evaluations are paramount in assessing user acceptability and clinical applicability of any needle safety devices. the evaluation should ensure that the safety feature works effectively and reliably, that the device is acceptable to health care practitioners and that it does not adversely affect patient care. hazard analysis critical control points (haccp) has been used for many years in the food industry to identify and control hazards in food production. it is a systems approach involving a seven stage process starting with the development of a flowchart describing the process, identifying areas (critical control points) where a hazard may occur and then establishing monitoring and control procedures. clinical governance introduced audit and quality improvement into the nhs. winning ways recommended the use of haccp in preventing hcais and the introduction of haccp is particularly suitable for hospital environmental hygiene. within the catering industry there are several good examples of cleaning and disinfection haccp flowcharts, which could be adapted for acute care settings. however all processes need to be defined locally in order to address the particular hazards within the organisation and the people responsible for monitoring them. in adapting these guidelines into local protocols, one should also consider the use of haccp. total number of articles located = abstract indicates that the article: relates to infections associated with hospital hygiene, is written in english, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text confirms that the article relates to infections associated with hospital hygiene is written in english, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. total number of articles selected for appraisal during sift = all articles which described primary research, a systematic review or, a meta-analysis and met the sift criteria were independently critically appraised by two appraisers. consensus and grading was achieved through discussion. total number of articles accepted after critical appraisal = total number of articles rejected after critical appraisal = evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. the summary reports were, in turn, used as the basis for guideline writing. total number of articles located = , abstract indicates that the article: relates to infections associated with hand hygiene, is written in english, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text confirms that the article relates to infections associated with hand hygiene is written in english, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. total number of articles selected for appraisal during sift = all articles which described primary research, a systematic review or, a meta-analysis and met the sift criteria were independently critically appraised by two appraisers. consensus and grading was achieved through discussion. evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. the summary reports were, in turn, used as the basis for guideline writing. sharps -systematic review process abstract indicates that the article: relates to infections associated with protective clothing, is written in english, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text confirms that the article relates to infections associated with protective clothing is written in english, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. total number of articles selected for appraisal during sift = all articles which described primary research, a systematic review or, a meta-analysis and met the sift criteria were independently critically appraised by two appraisers. consensus and grading was achieved through discussion. total number of articles accepted after critical appraisal = total number of articles rejected after critical appraisal = evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. the summary reports were, in turn, used as the basis for guideline writing. . what is the evidence that recommended modes of use and disposal of sharps reduce the incidence of sharps injury in health care workers? . what is the evidence that education and training interventions improve health care workers adherence to recommended modes of practice? . what is the evidence that the use of needle-free devices reduce occupational exposure to bloodborne pathogens? . is there any cost effectiveness evidence relating to the above? . what are the training and education implications for staff and patients? abstract indicates that the article: relates to infections associated with sharps, is written in english, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text confirms that the article relates to infections associated with sharps is written in english, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. all articles which described primary research, a systematic review or, a meta-analysis and met the sift criteria were independently critically appraised by two appraisers. consensus and grading was achieved through discussion. total number of articles accepted after critical appraisal = total number of articles rejected after critical appraisal = evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. the summary reports were, in turn, used as the basis for guideline writing. this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. all recommendations are endorsed equally and none is regarded as optional. these recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. these guidelines apply to adults and children aged one year and older and should be read in conjunction with the guidance on standard principles. the recommendations are divided into five distinct interventions: . assessing the need for catheterisation; . selection of catheter type and system; . catheter insertion; . catheter maintenance; and . education of patients, relatives and healthcare workers. background and context of the guidelines catheter associated urinary tract infection (cauti) is the most common nosocomial infection in hospitals. most bacteria causing infection associated with catheterisation gain access to the urinary tract either extraluminally or intraluminally. extraluminal contamination may occur as the catheter is inserted, by contamination of the catheter from the health care worker's hands or from the patient's own colonic or perineal flora. extraluminal contamination is also thought to occur by microorganisms ascending from the perineum. intraluminal contamination occurs by reflux of bacteria from a contaminated urine drainage bag. bacteria quickly develop into colonies known as biofilms which adhere to the catheter surface and drainage bag. a biofilm forms when bacteria attach to a surface and subsequently encase themselves in an exopolymeric material. such bacteria are morphologically and physiologically different from free-living planktonic bacteria. bacteria in biofilms have considerable survival advantages over free-living microorganisms, being extremely resistant to antibiotic therapy. these biofilms cause further problems if the bacteria produce the enzyme urease, such as proteus mirabilis. the urine then becomes alkaline, causing the crystallisation of calcium and magnesium phosphate within the urine, which then is incorporated into the biofilm resulting in encrustation of the catheter over a period of time. encrustation is generally associated with longterm catheterisation, since it has a direct relationship with the length of catheterisation. we have previously described the systematic review process in section . . for detailed descriptions of previous systematic reviews which have contributed to the evidence base underpinning these guidelines readers should consult the original guidelines, the guidelines for the prevention of healthcare associated infections in primary and community care and our interim report. search questions were developed from advice received from our specialist advisors and the results of the searches are found in section . . the process outlined in section . refers only to the most recent systematic review of the literature undertaken in . catheterising patients places them in significant danger of acquiring a urinary tract infection. the longer a catheter is in place, the greater the danger there is consistent evidence that a significant number of healthcare-associated infections in hospital are related to urinary catheterisation. , [ ] [ ] [ ] the risk of infection is associated with the method and duration of catheterisation, the quality of catheter care and host susceptibility. urinary catheterisation is a frequent intervention during clinical care in hospital affecting a significant number of patients at any one time. the highest incidence of infection is associated with indwelling urethral catheterisation. the per day risk of the development of bacteriuria appears comparable throughout catheterisation ( - percent) but the cumulative risk increases with duration of catheterisation. [ ] [ ] [ ] consequently, around percent of hospitalised patients catheterised longer than - days contract bacteriuria. although frequently asymptomatic, - percent of patients with catheter-associated bacteriuria will develop symptoms of cauti. many of these infections are serious and lead to significant morbidity and mortality. of patients with a cauti, - percent develops bacteraemia and, of these, - die. , duration of catheterisation is strongly associated with risk of infection, i.e., the longer the catheter is in place, the higher the incidence of urinary tract infection. , advice from best practice emphasises the importance of documenting all procedures involving the catheter or drainage system in the patient's records and providing patients with adequate information in relation to the need for catheterisation and details of the insertion, maintenance and removal of their catheter. , there is some evidence to suggest that computer management systems improve documentation and in so doing reduce the length of time catheters are in situ. only is one catheter better than another? current evidence-based guidelines identified three experimental studies that compared the use of latex with silicone catheters. [ ] [ ] [ ] no significant difference in the incidence of bacteriuria was found. four studies compared the use of silver coated (silver alloy or silver oxide) catheters with silicone, hydrogel or teflon latex. [ ] [ ] [ ] [ ] a systematic review and meta-analysis of these and other studies found that silver alloy (but not silver oxide) catheters were associated with a lower incidence of bacteriuria. , new evidence related to the efficacy of using urinary catheters coated or impregnated with antiseptic or antimicrobial agents has emerged since our original review in . two subsequent reviews, , together with the current update review undertaken by us, have identified four systematic reviews and one meta-analysis that have examined this issue. [ ] [ ] [ ] [ ] [ ] in general, all of these five studies suggest antiseptic impregnated or antimicrobial-coated urinary catheters can significantly prevent or delay the onset of cauti when compared to standard untreated urinary catheters. the consensus in these five reviews of evidence however, is that the individual studies reviewed are generally of poor quality; for instance in one case only studies out of met the inclusion criteria and in another, of the six reports describing trials included, only one scored in the quality assessment the other five scored only . , studies investigating a wide range of coated or impregnated catheters are explored in the new evidence including: catheters coated or impregnated with: silver alloy , , - ; silver oxide ; gendine ; gentamicin and silver-hydrogel [ ] [ ] [ ] ; minocycline ; rifampicin ; chlorhexidine-silver sulfadiazine ; chlorhexidine-sulfadiazine-triclosan ; nitrofurazone ; and nitrofuroxone. new evidence suggests that catheters coated with silver alloy are clinically effective in reducing the incidence of cauti, but many studies are of poor methodological quality. consequently there remains inconclusive evidence to recommend their use in preference to other types of catheter at this time. despite their unit cost, there is a suggestion that these devices might be a cost-effective option if overall numbers of infections are significantly reduced through their use. the few studies that have explored the cost benefit/ effectiveness of using these devices have, however, also been inconclusive. , , , evidence from best practice indicates that the incidence of cauti in patients catheterised for a short time (up to one week) is not influenced by any particular type of catheter material. , however, many practitioners have strong preferences for one type of catheter over another. this preference is often based on clinical experience, patient assessment, and which materials induce the least allergic response. smaller gauge catheters with a ml balloon minimise urethral trauma, mucosal irritation and residual urine in the bladder, all factors that predispose to cauti. , however, in adults that have recently undergone urological surgery, larger gauge catheters may be indicated to allow for the passage of blood clots. choice of catheter material will depend class d on clinical experience, patient assessment and anticipated duration of catheterisation. select the smallest gauge catheter that class d will allow free urinary outflow. a catheter with a ml balloon should be used in adults. urological patients may require larger gauge sizes and balloons. epic : guidelines for preventing healthcare-associated infections in nhs hospitals s catheterisation is a skilled aseptic procedure despite evidence from one systematic review which suggests that the use of aseptic technique has not demonstrated a reduction in the rate of cauti, principles of good practice, clinical guidance , and expert opinion [ ] [ ] [ ] [ ] [ ] [ ] [ ] , together with findings from another systematic review agree that urinary catheters must be inserted using sterile equipment and an aseptic technique. expert opinion indicates that there is no advantage in using antiseptic preparations for cleansing the urethral meatus prior to catheter insertion. , urethral trauma and discomfort will be minimised by using an appropriate sterile, single-use lubricant or anaesthetic gel. ensuring healthcare practitioners are trained and competent in the insertion of urinary catheters will minimise trauma, discomfort and the potential for cauti. , , , uc catheterisation is an aseptic procedure. ensure that health care workers are trained and competent to carry out urethral catheterisation. clean the urethral meatus with sterile normal class d saline prior to the insertion of the catheter. use an appropriate lubricant from a sterile class d single use container to minimise urethral trauma and infection. leave the closed system alone! maintaining a sterile, continuously closed urinary drainage system is central to the prevention of cauti. , , , , , the risk of infection reduces from percent with an open system to - percent when a sterile closed system is employed. , , breaches in the closed system such as unnecessary emptying of the urinary drainage bag or taking a urine sample, will increase the risk of catheter-related infection and should be avoided. , , hands must be decontaminated and clean, non-sterile gloves worn before manipulation. a systematic review suggests that sealed (e.g., taped, pre-sealed) drainage systems contribute to preventing bacteriuria. there is limited evidence as to how often catheter bags should be changed. one study showed higher rates of symptomatic and asymptomatic cauti were associated with a three day urinary drainage bag change regimen when compared to no routine change regimen. best practice suggests changing only when necessary, i.e., according to either the manufacturers' recommendations or the patient's clinical need. , reflux of urine is associated with infection and consequently, drainage bags should be positioned in a way that prevents back-flow of urine. , it is also recommended that urinary drainage bags should be hung on an appropriate stand that prevents contact with the floor. a number of studies have investigated the addition of disinfectants and antimicrobials to drainage bags as a way of preventing cauti. three acceptable studies from our original systematic review demonstrated no reduction in the incidence of bacteriuria following the addition of hydrogen peroxide or chlorhexidine to urinary drainage bags. , [ ] [ ] [ ] a systematic review supports these findings in that it suggests that adding bacterial solutions to drainage bags has no effect on catheter associated infection. connect indwelling urethral catheters to class a a sterile closed urinary drainage system. meatal cleansing with antiseptic solutions is unnecessary our original systematic review considered six acceptable studies that compared meatal cleansing with a variety of antiseptic/antimicrobial agents or soap and water. no reduction was demonstrated in bacteriuria when using any of these preparations for meatal care compared with routine bathing or showering. [ ] [ ] [ ] [ ] [ ] [ ] our subsequent reviews , revealed two studies , that support these findings in that the outcomes indicate that the use of antiseptics provides no benefit in respect of meatal/peri-urethral hygiene. expert opinion [ ] [ ] [ ] and another systematic review support the view that vigorous meatal cleansing is not necessary and may increase the risk of infection and that daily routine bathing or showering is all that is needed to maintain meatal hygiene. class a that is needed to maintain meatal hygiene. none of our systematic review evidence demonstrates any beneficial effect of bladder irrigation, instillation or washout with a variety of antiseptic or antimicrobial agents in preventing cauti. , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] three studies, however, suggest that an acid washout solution (suby g) is effective in reducing catheter encrustation. , , evidence from best practice supports the findings in respect of bladder irrigation, instillation and washout and indicates that the introduction of such agents may have local toxic effects and contribute to the development of resistant microorganisms. however, continuous or intermittent bladder irrigation may be indicated during urological surgery or to manage catheter obstruction. , [ ] [ ] [ ] uc bladder irrigation, instillation or washouts class a should not be used to prevent catheterassociated infection. given the frequency of urinary catheterisation in hospital patients and the associated risk of urinary tract infection, it is important that patients, their relatives and healthcare workers responsible for catheter insertion and management are educated about infection prevention. all those involved must be aware of the signs and symptoms of urinary tract infection and how to access expert help when difficulties arise. healthcare professionals must be confident and proficient in procedures associated with preventing cauti. in developing the recommendations we identified several areas that were inadequately addressed in the literature. we recommend further research in the following areas. epidemiological studies of the prevalence and incidence of bacteriuria/urinary tract infection during short-term catheterisation in different populations and different care settings. these should at least encompass the predominant populations, i.e. older people and those undergoing surgery. there needs to be clear definition of the 'cases' and the populations from which they are drawn. randomised controlled trials of the efficacy of antiseptic/antimicrobial coated/impregnated urethral catheters for short-term use. these need to be high quality studies, using the hospital's actual catheter-associated uti prevalence rather than national data, and appropriate follow-up. randomised controlled trials of strategies to establish how often catheters and catheter bags need to be changed. this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. all recommendations are endorsed equally and none is regarded as optional. these recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. background and context to the guidelines bloodstream infections associated with the insertion and maintenance of central venous access devices (cvad) are among the most dangerous complications of healthcare that can occur, worsening the severity of the patient's underlying ill health, prolonging the period of hospitalisation and increasing the cost of care. [ ] [ ] [ ] [ ] approximately in every patients admitted to hospital in the uk acquires a bloodstream infection, and nearly one third of these infections are related to central venous access devices. catheter related blood stream infection (cr-bsi) involves the presence of systemic infection and evidence implicating the cvad as its source, i.e., the isolation of the same microorganism from blood cultures as that shown to be significantly colonising the cvad of a patient with clinical features of bacteraemia. catheter colonization refers to a significant growth of microorganisms on either the endoluminal or the external catheter surface beneath the skin in the absence of systemic infection. [ ] [ ] [ ] the microorganisms that colonise catheter hubs and the skin adjacent to the insertion site are the source of most cr-bsi. coagulase-negative staphylococci, particularly staphylococcus epidermidis, are the most frequently implicated microorganisms associated with cr-bsi. other microorganisms commonly involved include staphylococcus aureus, candida species and enterococci. cr-bsi is generally caused either by skin microorganisms at the insertion site that contaminate the catheter during insertion and migrate along the cutaneous catheter track, or microorganisms from the hands of healthcare workers that contaminate and colonise the catheter hub during care interventions. infusate contamination or haematogenous seeding from site of infection elsewhere in the body is more rarely implicated as a cause of cr-bsi. abstract indicates that the article: relates to infections associated with short-term indwelling urinary catheters, is written in english, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text confirms that the article relates to infections associated with short-term indwelling urinary catheters, is written in english, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. total number of articles selected for appraisal during sift = all articles which described primary research, a systematic review or, a meta-analysis and met the sift criteria were independently critically appraised by two appraisers. consensus and grading was achieved through discussion. evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. the summary reports were, in turn, used as the basis for guideline writing. what is the evidence for these guidelines? evidence upon which practice can be based is derived from a range of sources and through varying processes. these guidelines are primarily based upon an expert review of evidence-based guidelines for preventing intravascular devicerelated infections developed at the centers for disease control and prevention (cdc) in the united states of america by the healthcare infection control practices advisory committee (hicpac) which were updated in . using a validated guideline appraisal instrument developed by the agree collaboration, three experienced appraisers independently reviewed the updated guidelines, taking into consideration supplementary information provided by hicpac at our request. we concluded that the development processes were valid and that the guidelines were evidence-based, categorised to the strength of the evidence examined, reflective of current concepts of best practice, and acknowledged as the most authoritative reference guidelines currently available. they were subsequently used by us as the principal source of evidence for updating the first version of the epic guidelines. in preparing the epic guidance, we conducted a final updating systematic review which is described in section . . this search was confined to elements of infection prevention where expert members of the guideline advisory group indicated new developments or changes in technology had occurred, or where pertinent new experimental trials or systematic reviews had been published. following our reviews, guidelines were drafted which described recommendations within the intervention categories listed below: . education of healthcare workers and patients; . general asepsis; . selection of catheter type; . selection of catheter insertion site; . maximal sterile barrier precautions during catheter insertion; . cutaneous antisepsis; . catheter and catheter site care; . catheter replacement strategies; and . general principles for catheter management. these guidelines apply to caring for all adults and children over the age of year in nhs acute care settings with a cvad which is being used for the administration of fluids, medications, blood components and/or total parenteral nutrition (tpn). they should be used in conjunction with the recommendations on standard principles for preventing hcai previously described in these guidelines. although these recommendations describe general principles of best practice that apply to all patients in hospital in which a cvad is being used, they do not specifically address the more technical aspects of the care of infants under the age of year or those children or adults receiving haemodialysis, who will generally have their cvad managed in dialysis centres. because these recommendations describe broad general statements of best practice, they need to be adapted and incorporated into local practice guidelines. to improve patient outcomes and reduce healthcare costs, it is essential that everyone involved in caring for patients with cvad is educated about infection prevention. healthcare workers in hospitals need to be confident and proficient in infection prevention practices and to be aware of the signs and symptoms of clinical infection. wellorganised educational programmes that enable healthcare worker to provide, monitor, and evaluate care and to continually increase their competence are critical to the success of any strategy designed to reduce the risk of infection. evidence reviewed by hicpac consistently demonstrated that the risk of infection declines s r.j. pratt et al. following the standardisation of aseptic care and increases when the maintenance of intravascular catheters is undertaken by inexperienced healthcare workers. additional evidence demonstrates that relatively simple education programmes focused on training healthcare workers to adhere to local evidence-based cvad protocols may decrease the risk to patients of cr-bsi. good standards of hand hygiene and antiseptic technique can reduce the risk of infection because the potential consequences of catheterrelated infections (cr-infections) are so serious, enhanced efforts are needed to reduce the risk of infection to the absolute minimum. for this reason, hand antisepsis and proper aseptic nontouch technique (antt) are required for changing catheter dressings and for accessing the system. , hand antisepsis can be achieved by washing hands with an antimicrobial liquid soap and water or by using an alcohol-based handrub. when hands are visibly dirty or contaminated with organic material, such as blood and other body fluids or excretions, they must first be washed with liquid soap and water if alcohol-based handrubs are going to be used to achieve hand antisepsis. appropriate antt does not necessarily require sterile gloves; a new pair of disposable non-sterile gloves can be used in conjunction with a nontouch technique, for example, in changing catheter site dressings. the standard principles for preventing hcai previously described in these guidelines gives additional advice on hand decontamination, the use of gloves and other protective equipment. selecting the right catheter for the right patient can minimise the risk of infection different types of cvad are available, i.e.: • made of different materials; • have one or more lumens; • coated or impregnated with antimicrobial or antiseptic agents or heparin-bonded; • cuffed and designed to be tunnelled; • having totally implantable ports. the selection of the most appropriate cvad for each individual patient can reduce the risk of subsequent cr-related infection (cr-infection). although catheter material may be an important determinant of cr-infection, evidence available to hicpac when developing their guidelines was inconclusive and they were unable to draw any specific conclusions about the contribution of catheter material to cr-infections. , teflon ® and polyurethane catheters have been associated with fewer infections than catheters made of polyvinyl chloride or polyethylene. there is no additional evidence that demonstrates conclusively that cr-infection rates vary with different materials. in england, short-term cvad are almost always made of polyurethane and longterm tunnelled catheters are usually made of silicone. number of catheter lumens clinicians often prefer multi-lumen cvad because they permit the concurrent administration of various fluids and medications, hyperalimentation, and haemodynamic monitoring among critically ill patients. hicpac examined several randomised controlled trials and other studies which suggested that multi-lumen catheters were associated with a higher risk of infection than were single lumen catheters. , [ ] [ ] [ ] [ ] [ ] however, other studies examined by hicpac failed to demonstrate a difference in the rates of cr-bsi. , hicpac noted that multi-lumen catheter insertion sites may be particularly prone to infection because of increased trauma at the insertion site or because multiple ports increase the frequency of cvad manipulation. , hicpac also noted that although patients with multi-lumen catheters tend to be more ill than those without such catheters, the infection risk observed with these catheters may have been independent of the patient's underlying disease severity. two additional studies were identified from our systematic reviews. a systematic review and quantitative meta-analysis focused on determining the risk of cr-bsi and catheter colonisation in multilumen catheters compared with single-lumen catheters. reviewers reported that although cr-bsi was more common in patients with multilumen when compared with single-lumen catheters, when confined to high quality studies that control for patient differences, there is no significant difference in rates of cr-bsi. this analysis suggests that multilumen catheters are not a significant risk factor for increased cr-bsi or local catheter colonisation compared with single-lumen cvad. another systematic review and quantitative meta-analysis tested whether single versus multilumen cvad had an impact on catheter colonisation and cr-bsi. study authors concluded that there is some evidence from randomised controlled trials (rcts) with data on cvad, that for every single-lumen catheters inserted, one cr-bsi will be avoided which would have occurred had multi-lumen catheters been used. as authors were only able to analyze a limited number of trials, further large rcts of adequate power and rigour are needed to confirm these findings. in the meantime, it may be reasonable for patients who need a cvad to choose a singlelumen catheter whenever there is no indication for a multi-lumen catheter. tunnelled and totally implantable ports surgically implanted (tunnelled) cvad, e.g., hickman ® catheters, are commonly used to provide vascular access (and stable anchorage) to patients requiring long-term intravenous therapy. alternatively, totally implantable intravascular devices, e.g., port-a-cath, ® are also tunnelled under the skin but have a subcutaneous port or reservoir with a self-sealing septum that is accessible by needle puncture through intact skin. in developing their guidelines, hicpac examined multiple studies that compared the incidence of infection associated with long-term tunnelled cvad and/or totally implantable intravascular devices with that from percutaneously (non-tunnelled) inserted cvad. although in general most studies reported a lower rate of infection in patients with tunnelled cvad, [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] some studies (including one randomised controlled trial) found no significant difference in the rate of infection between tunnelled and non-tunnelled catheters. , however, most studies examined by hicpac concluded that totally implantable devices had the lowest reported rates of cr-bsi compared to either tunnelled or non-tunnelled cvad. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] additional evidence was obtained from studies of efficacy of tunnelling to reduce cr-infections in patients with short-term cvad. one randomised controlled trial demonstrated that subcutaneous tunnelling of short-term cvad inserted into the internal jugular vein reduced the risk for cr-bsi. in a later randomised controlled trial, the same investigators failed to show a statistically significant difference in the risk for cr-bsi for subcutaneously tunnelled femoral vein catheters. an additional meta-analysis of randomised controlled trials focused on the efficacy of tunnelling short-term cvad to prevent crinfections. data synthesis demonstrated that tunnelling decreased catheter colonisation by % and decreased cr-bsi by % in comparison with non-tunnelled placement. the majority of the benefit in the decreased rate of catheter-sepsis came from one trial of cvad inserted at the internal jugular site. the reduction in risk was not significant when pooled with data from five subclavian catheter trials. tunnelling was not associated with increased risk of mechanical complications from placement or technical difficulties during placement; these outcomes were not rigorously evaluated. this meta-analysis concluded that tunnelling decreased crinfections. however, a synthesis of the evidence in this meta-analysis does not support routine subcutaneous tunnelling of short-term subclavian venous catheters and this cannot be recommended unless efficacy is evaluated at different placement sites and relative to other interventions. neither we nor hicpac identified any additional evidence in updating our systematic reviews. some catheters and cuffs are marketed as antiinfective and are coated or impregnated with antimicrobial or antiseptic agents, e.g., chlorhexidine/ silver sulfadiazine, minocycline/rifampin, platinum/ silver, and ionic silver in subcutaneous collagen cuffs attached to cvad. evidence reviewed by hicpac indicated that the use of antimicrobial or antiseptic-impregnated cvad in adults whose catheter is expected to remain in place for more than days can decrease the risk for cr-bsi. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] this may be cost-effective in high risk patients (intensive care, burn and neutropenic patients) and in other patient populations in which the rate of cr-bsi exceeds . per , catheter days despite implementing a comprehensive strategy to reduce rates of cr-bsi. a more recent meta-analysis analysed rcts published between - and which included data on , catheters ( , anti-infective and , control). eleven of the trials in this metaanalysis were conducted in intensive care unit settings; among oncologic patients, among surgical patients; among patients receiving tpn; among other patient populations. study authors concluded that antibiotic and chlorhexidine-silver sulfadiazine coatings are anti-infective for short (approximately week) insertion time. for longer insertion times, there are no data on antibiotic coating, and there is evidence of lack of effect for first generation chlorhexidine-silver sulfadiazine coating. for silver-impregnated collagen cuffs, there is evidence of lack of effect for both shortand long-term insertion. second generation chlorhexidine/silver sulfadiazine catheters with chlorhexidine coating both the internal and external luminal surfaces are now available. the external surface of these catheters has three times the amount of chlorhexidine and extended release of the surface bound antiseptics than that in the first generation catheters (which are coated with chlorhexidine/silver sulfadiazine only on the external luminal surface). early studies indicated that the prolonged anti-infective activity associated with the second generation catheters improved efficacy in preventing infections. the most recent appraisal of all of the evidence for the clinical and cost-effectiveness of cvad treated with antimicrobial agents in preventing cr-bsi is a systematic review and economic evaluation recently conducted by the liverpool reviews and implementation group (lrig). study authors conclude that rates of cr-bsi are statistically significantly reduced when an antimicrobial cvad was used. studies report the best effect when catheters were treated with minocycline/rifampin, or internally and externally treated with silver or chlorhexidine/silver sulfadiazine. a trend to statistical significance was seen in catheters only extraluminally coated. investigation of other antibiotic treated catheters is limited to single studies with non-significant results. hicpac guidelines recommend the use of an antimicrobial or antiseptic-impregnated cvad in adults whose catheter is expected to remain in place for more than days if, after implementing a comprehensive strategy to reduce rates of cr-bsi, the cr-bsi rate remains above the goal set by the individual institution based on benchmark rates and local factors. selecting the best insertion site for the patient can minimise the risk of infection several factors need to be assessed when determining the site of cvad placement, including: • patient-specific factors (e.g., pre-existing cvad, anatomic deformity, bleeding diathesis, some types of positive pressure ventilation); epic : guidelines for preventing healthcare-associated infections in nhs hospitals s • relative risk of mechanical complications (e.g., bleeding, pneumothorax, thrombosis); • the risk of infection. hicpac concluded that the site at which a cvad is placed can influence the subsequent risk of crinfection because of variation in both the density of local skin flora and risk of thrombophlebitis. cvad are generally inserted in the subclavian, jugular or femoral veins, or peripherally inserted into the superior vena cava by way of the major veins of the upper arm, i.e., the cephalic and basilar veins of the antecubital space. multiple studies examined by hicpac concluded that cvad inserted into subclavian veins had a lower risk for cr-infection than those inserted in either jugular or femoral veins, but none of these was a randomised controlled trial. hicpac stated that internal jugular insertion sites may pose a greater risk for infection because of their proximity to oropharyngeal secretions and because cvad at this site are difficult to immobilise. they noted, however, that mechanical complications associated with catheterisation might be less common with internal jugular than with subclavian vein insertion. hicpac noted that no rct satisfactorily has compared cr-infection rates for catheters placed in jugular, subclavian, and femoral sites. however, both previous and new evidence examined by hicpac demonstrated that catheters inserted into an internal jugular vein have been associated with higher risks for cr-infection than those inserted into a subclavian or femoral vein. , , femoral catheters have been demonstrated to have relatively high colonization rates when used in adults and should be avoided because they are presumed to be associated with a higher risk of deep vein thrombosis (dvt) and cr-infection than are internal jugular or subclavian catheters. [ ] [ ] [ ] [ ] [ ] [ ] thus, in adult patients, a subclavian site is preferred for infection control purposes, although other factors, e.g., the potential for mechanical complications, risk for subclavian vein stenosis, and catheter-operator skill, should be considered when deciding where to place the catheter. hicpac cited a meta-analysis of studies and guidelines from the national institute for health and clinical excellence (nice) indicate that the use of bedside ultrasound for the placement of cvad substantially reduced mechanical complications compared with the standard landmark placement technique. , consequently, the use of ultrasound may indirectly reduce the risk of infection by facilitating mechanically uncomplicated subclavian placement. peripherally inserted cvad (picc) may be used as an alternative to subclavian or jugular vein catheterisation. these are inserted into the superior vena cava by way of the major veins of the upper arm. hicpac stated that they are less expensive, associated with fewer mechanical complications, e.g., thrombosis, haemothorax, infiltration and phlebitis, and easier to maintain than short peripheral venous catheters, i.e., a reduced need for frequent site rotation. additionally, previous evidence examined by hicpac suggested that picc are associated with a lower rate of infection than that associated with other non-tunnelled cvad, perhaps because the skin at the antecubital fossa is less moist and oily and colonised by fewer microorganisms than the chest and neck. , , hicpac also noted that an antecubital placement removes the catheter away from endotracheal and nasal secretions. finally, they noted that further studies were needed to adequately determine how long picc could be safely left in place and to determine whether routine replacement influenced the risk of associated infection. we examined a prospective cohort study using data from two randomized trials and a systematic review published in . in the review the authors reported a rate of picc-bsi of . per , picc-days. this was comparable to the rates reported in their prospective cohort study ( . to . per , catheter-days) and similar to that reported with prospectively studied, short-term non-cuffed cvad placed percutaneously in the internal jugular, subclavian or femoral veins in inpatients (approximately . per , days). investigators concluded that picc used in high-risk hospitalised patients are associated with a rate of cr-bsi similar to conventional cvad placed in the internal jugular or subclavian veins ( to per , catheter-days). this rate is much higher than with picc used exclusively in the outpatient setting (approximately . per , catheterdays). they question whether the growing trend in many hospital haematology and oncology services to switch from the use of cuffed and tunnelled cvad to picc is justified, particularly since picc are more vulnerable to thrombosis and dislodgment, and are less useful for drawing blood specimens. moreover, picc are not advisable in patients with renal failure and impending need for dialysis, in whom preservation of upper-extremity veins is needed for fistula or graft implantation. furthermore: '…the assumption that picc are safer than conventional cvad with regard to the risk of infection is in question and should be assessed by a larger, adequately powered randomized trial that assesses peripheral vein thrombo-phlebitis, picc-related thrombosis, and premature dislodgment, as well as cr-bsi.' cvad using maximal sterile barrier precautions during cvad placement will significantly reduce the risk of infection the primacy of strict adherence to hand decontamination and aseptic technique as the cornerstone for preventing cr-infection is widely accepted. although this is considered adequate for preventing infections associated with the insertion of short peripheral venous catheters, it is recognised that central venous catheterisation carries a significantly greater risk of infection. however, the level of barrier precautions needed to prevent infection during cvad insertion was controversial at the time of the development of the hicpac guidelines. studies examined by hicpac concluded that if maximal sterile barrier precautions (msb) were used during cvad insertion, catheter contamination and subsequent cr-infections could be significantly minimised. , [ ] [ ] [ ] one of these studies was a prospective randomised trial that tested the efficacy of maximal sterile barriers to reduce infections associated with long-term nontunnelled subclavian silicone catheters. when msb were compared with routine procedures, they significantly decreased the risk of cr-bsi. msb involve wearing sterile gloves and gown, a cap, mask and using a large sterile drape during insertion of the catheter as opposed to routine infection prevention procedures that involve wearing only sterile gloves and the use of a small drape. however, there is no specific evidence that wearing a facemask or cap during catheter insertion is important in preventing cr-bsi. it has been generally assumed that cvad inserted in the operating theatre posed a lower risk of infection than did those inserted on inpatient wards or other patient care areas. data examined by hicpac from two prospective studies suggests that the difference in risk of infection depended largely on the magnitude of barrier protection used during catheter insertion, rather than the surrounding environment, i.e., ward versus operating room. , previous expert reviewers who have examined the above evidence agree that maximal sterile barrier precautions are essential during cvad placement to reduce the risk of infection. , , [ ] [ ] [ ] systematic review evidence a systematic review published in aimed to determine the value of msb to prevent cvadrelated infection. msb were defined as: person inserting the cvad wear a head cap, facemask, sterile body gown, and sterile gloves and uses a full-size sterile drape. their search identified articles discussing the prevention of cvad-related infections. the majority of these articles were review articles or consensus statements. only three primary research studies comparing infection outcomes using msb with less stringent barrier techniques were identified and included in the review. authors identified no additional unpublished or ongoing primary studies. all three studies included in the review concluded that the use of msb resulted in a reduction in catheterrelated infections. the studies differed notably in their patient populations, research designs, and healthcare settings. study authors concluded that using msb has been found to decrease transmission of microorganisms, to delay colonization, and to reduce the rate of hospital-acquired infections. they suggest that biological plausibility and the available evidence support using msb during routine insertion of a cvad to minimise the risk of infection. they recommend that given the lack of adverse patient reactions, the relatively low cost of msb, and the high cost of cr-bsi, it is probable that msb will prove to be a cost-effective or even a cost-saving intervention. appropriate preparation of the insertion site will reduce the risk of catheter-related infection microorganisms that colonise catheter hubs and the skin surrounding the cvad insertion site are the cause of most cr-bsis. , , the risk of infection increases with the density of microorganisms around the insertion site. skin cleansing/ antisepsis of the insertion site is therefore one of the most important measures for preventing crinfection. an important prospective randomised trial of agents used for cutaneous antisepsis demonstrated that % aqueous chlorhexidine was superior to either % povidone-iodine or % alcohol for preventing central venous and arterial cr-infections. an additional study has since confirmed the superior efficacy of % aqueous chlorhexidine compared to povidone iodine in substantially reducing central venous catheter colonisation. direct comparisons of aqueous versus alcoholic solutions of chlorhexidine have not been undertaken in relation to cutaneous antisepsis for preventing cr-infections. however, an alcoholic solution of chlorhexidine combines the benefits of rapid action and excellent residual activity. the application of organic solvents, such as acetone or ether, to 'defat' (remove skin lipids) the skin before catheter insertion and during routine dressing changes had been a standard component of many hyperalimentation protocols. however, there was no evidence available to hicpac to show that the use of these agents provided any protection against cr-infection and their use could greatly increase local inflammation and patient discomfort. several studies were examined that focused on the application of antimicrobial ointments to the catheter site at the time of catheter insertion, or during routine dressing changes, to reduce microbial contamination of catheter insertion sites. reported efficacy in preventing crinfections by this practice yielded contradictory findings. [ ] [ ] [ ] [ ] [ ] [ ] there was also concern that the use of polyantibiotic ointments that were not fungicidal could significantly increase the rate of colonisation of the catheter by candida species. , systematic review evidence a meta-analysis published in assessed studies that compared the risk for cr-bsi following insertion-site skin care with either any type of chlorhexidine gluconate (chg) solution versus povidone iodine (pi) solution. this analysis indicated that the use of chg rather than pi can reduce the risk for cr-bsi by approximately % (risk ratio, . [ci, . to . ]) in hospitalised patients who require short-term catheterisation, i.e., for every catheter sites disinfected with chg rather than pi, episodes of catheter colonization and episodes of cr-bsi would be prevented. in this analysis, several types of chg solutions were used in the individual trials, including . percent or percent chg alcohol solution and . percent or percent chg aqueous solution. all of these solutions provided a concentration of chg that is higher than the minimal inhibitory concentration (mic) for most nosocomial bacteria and yeasts. subset analysis of aqueous and non-aqueous solutions showed similar effect sizes, but only the subset analysis of the five studies that used alcoholic chg solution produced a statistically significant reduction in cr-bsi. because few studies used chg aqueous solution, the lack of a significant difference seen for this solution compared with pi solution may be a result of inadequate statistical power. a prospective randomised trial in germany and published in investigated the optimal disinfection regimen at the time of catheter insertion to avoid catheter colonisation, comparing skin disinfection performed with either povidoneiodine % (pvp-iodine), chlorhexidine . % propanol %, or chlorhexidine . % propanol % followed by pvp-iodine %. investigators found that significantly fewer catheter tips were colonized following skin disinfection of the insertion site with propanol/chlorhexidine followed by pvp-iodine (p = . ). study authors concluded that skin disinfection with sequential application of propanol/chlorhexidine followed by pvp-iodine was superior in the prevention of microbial cvad colonisation compared to either of the regimens alone. a randomised prospective multiple unit crossover trial conducted in france and published in compared the effectiveness in preventing central venous catheter colonization and infection of two protocols for pre-insertion cutaneous antisepsis using aqueous % povidone-iodine (pvp-i) or a solution of % pvp-i in % ethanol. investigators found that the incidence of catheter colonization was significantly lower in the alcoholic pvp-i solution protocol than in the aqueous pvp-i solution protocol (relative risk, . : % confidence interval, . - . , p < . ), and so was the incidence of cr-infection (relative risk, . : % confidence interval, . - . , p < . ). study authors concluded that the use of alcoholic pvp-i rather than aqueous pvp-i can significantly reduce the incidence of catheter-tip colonization and nosocomial catheter-related infection in intensive care units.this study was designed to demonstrate the superiority of alcoholic pvp-i over aqueous pvp-i in preventing cvad colonization. however, the weight of evidence in the majority of studies appraised in our review favours alcoholic chlorhexidine for preinsertion cutaneous antisepsis. cvad infections can be minimised by good catheter and insertion site care the safe maintenance of a cvad and relevant care of the insertion site are essential components of a comprehensive strategy for preventing crinfections. this includes good practice in caring for the patient's catheter hub and connection port, the use of an appropriate cvad site dressing regimen, and using flush solutions to maintain the patency of the cvad. choose the right dressing for insertion sites to minimise infection following cvad placement, a dressing is used to protect the insertion site. because occlusive dressings trap moisture on the skin, and provide an ideal environment for the rapid growth of local microflora, dressings for insertion sites must be permeable to water vapour. the two most common types of dressings used for insertion sites are sterile, transparent, semi-permeable polyurethane dressings coated with a layer of an acrylic adhesive ('transparent dressings'), and gauze and tape dressings. transparent dressings, e.g., opsite ® iv , tegaderm iv ® , are permeable to water vapour and oxygen, and impermeable to microorganisms. hicpac reviewed the evidence related to which type of dressing provided the greatest protection against infection and found little difference. they concluded that the choice of dressing can be a matter of preference. if blood is oozing from the catheter insertion site, a gauze dressing might be preferred. gauze dressings are not waterproof and require frequent changing in order to inspect the catheter site. they are rarely useful in patients with longterm cvad. sterile transparent, semi-permeable polyurethane dressings have become a popular means of dressing catheter insertion sites. they reliably secure the cvad, permit continuous visual inspection of the catheter site, allow patients to bathe and shower without saturating the dressing, and require less frequent change than that required for standard gauze and tape dressings, thus saving personnel time. a cochrane review of gauze and tape versus transparent polyurethane dressings for cvad concluded that there was no evidence demonstrating any difference in the incidence of cr-related infections between any of the dressing types compared in this review. each of these comparisons was based on no more than studies and all of these studies reported data from a small patient sample. therefore it is probable that the findings of no difference between dressing types is due to the lack of adequate data. they further concluded that because there is a high level of uncertainty regarding the risk of infection associated with the cvad dressings included in this review, at this stage it appears that the choice of dressing for cvad can be based on patient preference. cvad use an appropriate antiseptic agent for disinfecting the catheter insertion site during dressing changes hicpac described compelling evidence that aqueous chlorhexidine % was superior to either % povidone iodine or % alcohol in lowering cr-bsi rates when used for skin antisepsis prior to cvad insertion. , they made no recommendation for the use of any disinfectant agent for cleaning the insertion site during dressing changes. studies focused on the use of antimicrobial ointment applied under the dressing to the catheter insertion site to prevent cvad-related infection do not clearly demonstrate efficacy. , systematic review evidence a recent meta-analysis assessed studies that compared the risk for cr-bsi following insertionsite skin care with either any type of chlorhexidine gluconate (chg) solution versus povidone iodine (pi) solution. this analysis indicated that the use of chg rather than pi can reduce the risk for cr-bsi by approximately % (risk ratio, . [ci, . to . ]) in hospitalised patients who require short-term catheterisation, i.e., for every catheter sites disinfected with chg rather than pi, episodes of catheter colonization and episodes of cr-bsi would be prevented. in this analysis, several types of chg solutions were used in the individual trials, including . percent or percent chg alcohol solution and . percent or percent chg aqueous solution. all of these solutions provided a concentration of chg that is higher than the minimal inhibitory concentration (mic) for most nosocomial bacteria and yeasts. subset analysis of aqueous and non-aqueous solutions showed similar effect sizes, but only the subset analysis of the five studies that used alcoholic chg solution produced a statistically significant reduction in cr-bsi. because few studies used chg aqueous solution, the lack of a significant difference seen for this solution compared with pi solution may be a result of inadequate statistical power. most modern cvad and other catheter materials are generally alcohol-resistant, i.e., they are not damaged by contact with alcohol. however, alcohol and other organic solvents and oil-based ointments and creams may damage some types of polyurethane and silicon cvad tubing, e.g., some catheters used in haemodialysis. the manufacturer's recommendations for only using disinfectants that are compatible with specific catheter materials must be followed. cvad when and how catheters are replaced can influence the risk of infection a catheter replacement strategy is composed of two elements; the frequency and the method of catheter replacement. frequency hicpac noted that with short peripheral venous catheters, the risk of phlebitis and catheter colonisation, both associated with cr-infection, could be reduced by catheter replacement and site rotation every - hours. however, decisions regarding the frequency of cvad replacement were more complicated. they considered evidence that showed duration of catheterisation to be a risk factor for infection and which advocated routine replacement of cvad at specified intervals as a measure to reduce infection. , , , other studies, however, suggested that the daily risk of infection remains constant and showed that routine replacement of cvad, without a clinical indication, does not reduce the rate of catheter colonisation or the rate of cr-bsi. , conclusions from a systematic review agree that exchanging catheters by any method every three days was not beneficial in reducing infections, compared with catheter replacement on an as-needed basis. two methods are used for replacing cvad; placing a new catheter over a guide wire at the existing site, or percutaneously inserting a new catheter at another site. guide wire insertion has been the accepted technique for replacing a malfunctioning catheter (or exchanging a pulmonary artery catheter for a cvad when invasive monitoring was no longer needed) as they are associated with less discomfort and a significantly lower rate of mechanical complications than those percutaneously inserted at a new site. studies of the risks for infection associated with guide wire insertions examined by hicpac yielded conflicting results. one prospective study showed a significantly higher rate of cr-bsi associated with catheters replaced over a guide wire compared with catheters inserted percutaneously. however, three prospective studies (two randomised) showed no significant difference in infection rates between catheters inserted percutaneously and those inserted over a guide wire. , , since these studies suggest that the insertion of the new catheter at a new site does not alter the rate of infectious complications per day but does increase the incidence of mechanical complications, guide wire exchange is recommended. most studies examined by hicpac concluded that, in cases where the catheter being removed is known to be infected, guidewire exchange is contraindicated. , [ ] [ ] [ ] [ ] a systematic review concluded that, compared with new site replacement, guidewire exchange was associated with a trend toward a higher rate of subsequent catheter colonisation, regardless of whether patients had a suspected infection at the time of replacement. guidewire exchange was also associated with trends toward a higher rate of catheter exit-site infection and cr-bsi. however, guidewire exchange was associated with fewer mechanical complications relative to new-site replacement. methods are available and techniques have been described which allow a diagnosis of cr-bsi to be made without the need for catheter removal. such approaches could be used prior to the replacement of a new catheter over a guide wire in order to reduce the subsequent risk of crinfection. aseptic technique is important when accessing the system hicpac considered evidence demonstrating that contamination of the catheter hub is an important contributor to intraluminal microbial colonisation of catheters, particularly long-term catheters. [ ] [ ] [ ] [ ] [ ] [ ] [ ] in a relatively recent overview, additional evidence from a prospective cohort study suggested that frequent catheter hub manipulation increases the risk for microbial contamination. , during prolonged catherisation, catheter hubs are accessed more frequently, increasing the likeli-epic : guidelines for preventing healthcare-associated infections in nhs hospitals hood of a cr-bsi emanating from a colonised catheter hub rather than the insertion site. consequently, the reviewer commented that hubs and sampling ports should be disinfected before they are accessed and noted that both povidoneiodine and chlorhexidine are effective. , , systematic review evidence in a recent randomized prospective clinical trial conducted in england, the microbial contamination rate of luers of cvad with either posiflow ® needleless connectors or standard caps attached was investigated. the efficacy of: chlorhexidine gluconate . % w/v in industrial methylated spirit (ims) bp % w/w spray (hydrex ds ® ); sterile isopropyl alcohol (ipa) % w/w spray (spiriclens ® ); and % (w/v) aqueous povidone-iodine (betadine ® ) was assessed for the disinfection of intravenous connections. patients were designated to receive chlorhexidine/alcohol, isopropyl alcohol or povidone-iodine for pre-cvad insertion skin preparation and disinfection of the connections. after h in situ the microbial contamination rate of luers, with standard caps and with needleless connectors attached, was determined. the microbial contamination rate of the external compression seals of needleless connectors was also assessed to compare the efficacy of the three disinfectants. the internal surfaces of out of ( %) luers with standard caps were contaminated with microorganisms, whilst only out of ( . %) luers with needleless connectors were contaminated (p < . ). of those needleless connectors disinfected with isopropyl alcohol, . % were externally contaminated with microorganisms compared with . % disinfected with chlorhexidine/alcohol (p < . ) and . % with povidone-iodine (p < . ). these results suggest that the use of needleless connectors may reduce the microbial contamination rate of cvad luers compared with the standard cap. furthermore, disinfection of needleless connectors with either chlorhexidine/alcohol or povidone-iodine significantly reduced external microbial contamination. both these strategies may reduce the risk of catheter-related infections acquired via the intraluminal route. although now generally alcohol-resistant, some cvad and catheter hub materials may be chemically incompatible with alcohol or iodine and the manufacturer's recommendations must be complied with. although in-line filters reduce the incidence of infusion-related phlebitis, hicpac could find no reliable evidence to support their efficacy in preventing infections associated with intravascular catheters and infusion systems. infusate-related bsi is rare and hicpac concluded that filtration of medications or infusates in the pharmacy is a more practical and less costly way to remove the majority of particulates. furthermore, in-line filters might become blocked, especially with certain solutions, e.g., dextran, lipids, mannitol, thereby increasing the number of line manipulations and decreasing the availability of administered drugs. in our systematic review we found no additional good quality evidence to support their use for preventing infusate-related cr-bsi. however, there may be a role for the use of in-line filtration of parenteral nutrition solutions for reasons other than the prevention of infection but these are beyond the scope of these guidelines. cvad antibiotic lock prophylaxis, i.e., flushing and then filling the lumen of the cvad with an antibiotic solution and leaving it to dwell in the lumen of the catheter, is sometimes used in special circumstances to prevent cr-bsi, e.g., in treating a patient with a long-term cuffed or tunnelled catheter or port who has a history of multiple cr-bsi despite optimal maximal adherence to aseptic technique. evidence reviewed by hicpac demonstrated the effectiveness of this type of prophylaxis in neutropenic patients with long-term cvad. however, they found no evidence that routinely using this procedure in all patients with cvad reduced the risk of cr-bsi and may lead to an increase in antimicrobial resistant microorganisms. cvad patients with cancer often need to be given drugs and other treatments intravenously, so are frequently fitted with long-term tunnelled cvad. infections sometimes occur. clinical trial evidence shows it may be useful to give prophylactic antibiotics prior to inserting a tunnelled cvad or to flush the catheter with combined vancomycin and heparin, but microbial resistance may occur unless this practice is limited to highrisk patients. cvad maintaining cvad patency and preventing catheter thrombosis may help prevent infections indwelling central venous and pulmonary artery catheters are thrombogenic. thrombus forms on these catheters in the first few hours following placement and may serve as a nidus for microbial colonization of intravascular catheters. , thrombosis of large vessels occurs after long-term catheterisation in to % of patients. [ ] [ ] [ ] [ ] [ ] prophylactic heparin and warfarin have been widely used to prevent catheter thrombus formation and catheter related complications, such as deep venous thrombosis (dvt). , two types of heparin can be used: unfractionated (standard) heparin and low molecular weight heparins. although more expensive, low molecular weight heparins have a longer duration of action than unfractionated heparin and are generally administered by subcutaneous injection once daily. the standard prophylactic regimen of low molecular weight heparins are at least as effective and as safe as unfractionated heparin in preventing venous thrombo-embolism and does not require laboratory monitoring. a meta-analysis of randomised controlled trials evaluating the benefit of infused prophylactic heparin through the catheter, given subcutaneously or bonded to the catheter in patients with cvad found that prophylactic heparin: • was associated with a strong trend for reducing catheter thrombus (rr, . the authors of this meta-analysis concluded that heparin administration effectively reduces thrombus formation and may reduce catheterrelated infections in patients who have central venous and pulmonary artery catheters in place. they suggest that various doses of subcutaneous and intravenous unfractionated and low molecular weight heparins and new methods of heparin bonding need further comparison to determine the most cost-effective strategy for reducing catheter-related thrombus and thrombosis. there are many different preparations and routes of administration of heparin, and as yet there is no definite evidence that heparin reduces the incidence of cr-bsi, but this may reflect the heterogeneity of heparin and its administration. warfarin has also been evaluated as a means for reducing catheter-related thrombosis. a controlled trial of patients with solid tumours were randomised to receive or not to receive low-dose warfarin ( mg a day) beginning days prior to catheter insertion and continuing for days. warfarin was shown to be effective in reducing catheter-related thrombosis. in this study, warfarin was discontinued in % of patients due to prolongation of the prothrombin time. heparin versus normal saline intermittent flushes although many clinicians use low dose intermittent heparin flushes to fill the lumens of cvad locked between use in an attempt to prevent thrombus formation and to prolong the duration of catheter patency, the efficacy of this practice is unproven. despite its beneficial antithrombotic effects, decreasing unnecessary exposure to heparin is important to minimise adverse effects associated with heparin use, e.g., autoimmunemediated heparin-induced thrombocytopenia, allergic reactions and the potential for bleeding complications following multiple, unmonitored heparin flushes. the risks of these adverse effects can be avoided by using . percent sodium chloride injection instead of heparin flushes. a systematic review and meta-analysis of randomised controlled trials evaluating the effect of heparin on duration of catheter patency and on prevention of complications associated with the use of peripheral venous and arterial catheters concluded that heparin at doses of u/ml for intermittent flushing is no more beneficial than flushing with normal saline alone. this finding was in agreement with two other metaanalyses. , manufacturers of implanted ports or opened-ended catheter lumens may recommend heparin flushes for maintaining catheter patency and many clinicians feel that heparin flushes are appropriate for flushing cvad that are infrequently accessed. hicpac reviewed all of the evidence for intermittent heparin flushes and systemic heparin and warfarin prophylaxis and concluded that no data demonstrated that their use reduces the incidence of cr-bsi and did not recommend them for infection prevention purposes. , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] although their use for preventing cr-bsi remains controversial, patients who have cvad may also have risk factors for dvt and systemic anticoagulants may be prescribed for dvt prophylaxis. in addition, heparin flush solutions may be useful in helping to maintain patency in catheter lumens that are infrequently accessed and may also be recommended by manufacturers of implantable ports and for cvad used for blood processing, e.g., haemodialysis or apheresis. we did not identify and further new evidence when updating our systematic review. needle-free devices require vigilance needle-free infusion systems have been widely introduced into clinical practice to reduce the incidence of sharp injuries and the potential for the transmission of bloodborne pathogens to healthcare worker. hicpac examined evidence that these devices may increase the risk for cr-bsi and concluded that when they are used according to the manufacturers' recommendations, they do not substantially affect the incidence of cr-bsi. some of the devices available are more expensive than standard devices, may not be compatible with existing equipment, and may be associated with an increase in bloodstream infection rates. class d/gpp the optimal interval for the routine replacement of intravenous (iv) solution administration sets has been examined in three well-controlled studies reviewed by hicpac. data from each of these studies reveal that replacing administration sets no more frequently than hours after initiation of use is safe and cost-effective. when a fluid that enhances microbial growth is infused, e.g., lipid emulsions, blood products, more frequent changes of administration sets are indicated as these products have been identified as independent risk factors for cr-bsi. cvad this is a well researched area and few realistic research needs were identified in developing these guidelines. the following investigations, along with a health economic assessment, may inform future clinical practice. the effectiveness of subcutaneous low molecular weight heparins or low dose warfarin to prevent catheter thrombus, colonisation and cr-bsi. the infection risks associated with the use of peripherally inserted central catheters (picc). the impact of nurse consultants (intravenous therapy) and/or intravenous therapy teams on hospital cr-bsi rates. the efficacy and cost-effectiveness of antimicrobial impregnated cvad to provide sustained protection against crbsi in hospital patients with long term catherisation. the efficacy and cost-effectiveness of antimicrobial impregnated catheter site dressings in preventing catheter colonisation and cr-bsi. ensure that all healthcare workers are trained all healthcare worker involved in the care of people with cvad to implement these guidelines and assessed receive training and updates in the management of cvad. as competent. standard % support healthcare workers to consistently adhere to guideline recommendations. data collection: review of staff education records/direct observation/self-audit assess the need for continuing venous access evidence of regular and frequent assessment of the need for on a regular basis and remove a cvad as soon cvad and catheter discontinuation rates when the catheter is as clinically possible in order to reduce the no longer essential for medical management. risk for infection. standard % total number of articles located = abstract indicates that the article: relates to infections associated with central venous access devices, is written in english, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text confirms that the article relates to infections associated with central venous access devices, is written in english, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. total number of articles selected for appraisal during sift = all articles which described primary research, a systematic review or, a meta-analysis and met the sift criteria were independently critically appraised by two appraisers. consensus and grading was achieved through discussion. total number of articles accepted after critical appraisal = total number of articles rejected after critical appraisal = evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. the summary reports were, in turn, used as the basis for guideline writing. the epic project: developing national evidence-based guidelines for preventing healthcare associated infections. phase : guidelines for preventing hospital-acquired infections infection control: prevention of healthcare-associated infection in primary and community care updating the evidence-base for national evidence-based guidelines for preventing healthcare-associated infections in nhs hospitals in england: a report with recommendations updating the evidence-base for national evidence-based 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zhu, xinqiang; jiang, hong; he, na; tao, jun; leng, sean xiao; tong, tanjun; woo, jean title: a research agenda for ageing in china in the st century ( nd edition): focusing on basic and translational research, long-term care, policy and social networks date: - - journal: ageing res rev doi: . /j.arr. . sha: doc_id: cord_uid: s vzf q one of the key issues facing public healthcare is the global trend of an increasingly ageing society which continues to present policy makers and caregivers with formidable healthcare and socio-economic challenges. ageing is the primary contributor to a broad spectrum of chronic disorders all associated with a lower quality of life in the elderly. in , the chinese population constituted % of the world population, with . million chinese citizens aged and above ( +), and million aged or above ( +). china has become an ageing society, and as it continues to age it will continue to exacerbate the burden borne by current family and public healthcare systems. major healthcare challenges involved with caring for the elderly in china include the management of chronic non-communicable diseases (cncds), physical frailty, neurodegenerative diseases, cardiovascular diseases, with emerging challenges such as providing sufficient dental care, combating the rising prevalence of sexually transmitted diseases among nursing home communities, providing support for increased incidences of immune diseases, and the growing necessity to provide palliative care for the elderly. at the governmental level, it is necessary to make long-term strategic plans to respond to the pressures of an ageing society, especially to establish a nationwide, affordable, annual health check system to facilitate early diagnosis and provide access to affordable treatments. china has begun work on several activities to address these issues including the recent completion of the of the ten-year health-care reform project, the implementation of the healthy china action plan, and the opening of the national clinical research center for geriatric disorders. there are also societal challenges, namely the shift from an extended family system in which the younger provide home care for their elderly family members, to the current trend in which young people are increasingly migrating towards major cities for work, increasing reliance on nursing homes to compensate, especially following the outcomes of the ‘one child policy’ and the ‘empty-nest elderly’ phenomenon. at the individual level, it is important to provide avenues for people to seek and improve their own knowledge of health and disease, to encourage them to seek medical check-ups to prevent/manage illness, and to find ways to promote modifiable health-related behaviors (social activity, exercise, healthy diets, reasonable diet supplements) to enable healthier, happier, longer, and more productive lives in the elderly. finally, at the technological or treatment level, there is a focus on modern technologies to counteract the negative effects of ageing. researchers are striving to produce drugs that can mimic the effects of ‘exercising more, eating less’, while other anti-ageing molecules from molecular gerontologists could help to improve ‘healthspan’ in the elderly. machine learning, ‘big data’, and other novel technologies can also be used to monitor disease patterns at the population level and may be used to inform policy design in the future. collectively, synergies across disciplines on policies, geriatric care, drug development, personal awareness, the use of big data, machine learning and personalized medicine will transform china into a country that enables the most for its elderly, maximizing and celebrating their longevity in the coming decades. this is the nd edition of the review paper (fang ef et al., ageing re. rev. ). the research agenda in response to rapid population ageing in china has been broad, covering areas including the study of the ageing process itself in laboratory and animal studies, to clinical-level studies of drugs or other treatments for common chronic diseases, and finally policy-level research for the care of the elderly in hospital, community and residential care settings, and its influence on health and social care policies . chinese population statistics taken between - show a reduction in crude death rate (cdr) and total fertility rate (tfr), accompanied by an increase in life expectancy at birth and an expansion of the population aged and above ( +, termed the elderly) (fig. a) . as of , the population of mainland china constitutes % of global total, with . million chinese citizens aged +, million of whom are +. by , it is expected that there will be . billion chinese, with million aged +, a number representing . % of the country's total population (fig. b) . furthermore, among this ageing population, million are expected to reach an age of at least and . million are expected to become centenarians (fig. b) . when compared with their counterparts born a decade earlier, the current + generation has reduced annual mortality and disability rates, but has increased cognitive impairment and reduced objective physical performance capacity (zeng et al., b) . to achieve what may be considered a 'healthy ageing society', it is first important to address and prepare for the challenges and issues that are associated with rapidly ageing populations. ageing is the primary driver of most, if not all, chronic diseases, including cancer, cardiovascular diseases, diabetes, and neurodegenerative diseases, particularly alzheimer's disease (ad) and parkinson's disease (pd) (kerr et al., ; lautrup et al., ; lopez-otin et al., ) . the most predominant diseases affecting the elderly in china ( +, data from ) include sensory diseases, other non-communicable diseases, digestive diseases, respiratory infections and tuberculosis, skin and subcutaneous diseases, neurological diseases, and musculoskeletal disorders, among others (fig. c) . from to , there were dramatic increases in prevalence of all diseases, excluding a very minor reduction in 'neglected tropical diseases and malaria' (fig. c) . the major diseases responsible for death of the elderly in china are cardiovascular diseases, neoplasms, chronic respiratory diseases, and neurological diseases, among others (figs. d and ). compared to their younger counterparts, the elderly population are more fragile, and susceptible to conditions such as cardiovascular diseases, chronic respiratory diseases, diabetes, kidney diseases, unintentional injuries, hiv/aids and sexually transmitted diseases (stds), among others (fig. b ). in comparison with data from , new patterns of disease mortality characterize the modern elderly, such as a dramatic reduction in the percentage of death contributed by 'neurological disorders' with an increase in deaths due to hiv/aids and stds (fig. b, d) . recognition of the current disease demographics in the elderly in china, and accurate prediction of future trends will enable us to be best prepared for different healthcare needs at different times. in wake of the expanding ageing society in china, and the formidable socio-economic and healthcare challenges, we offer the nd edition of our previously published review . here, we aim to provide an update regarding the situation of the elderly in china using a range of expertise and suggestions from multiple fields which may further propel the exciting and ongoing reforms to china's healthcare system. we hope to explore different ageing care models that can be used to best produce a healthy ageing society (chen, ; yip et al., ; zhan et al., ) . the following sections highlight recent developments in the above areas as well as areas for future research. based on ageing phenotypes and the major disease demographics in the elderly in china (figs. and ), we chose to focus on frailty (including sarcopenia as an independent subsection), cncds (including cardiovascular disease as an independent subsection), mental health disorders, dental health challenges, elderly infections and immune diseases, as well as hiv, syphilis, and other stds. in view of recent reviews on other grand challenges, including cancer tsoi et al., ) , chronic respiratory diseases (zhu et al., ) , diabetes and kidney diseases (hu and jia, ; wei et al., ) , these areas will not explored here. frailty is a biologic syndrome characterized by deteriorating function across a broad spectrum of physiological symptoms (fried et al., ) . it can be thought of as a state of vulnerability. some have proposed an index approach to categorize different degrees of frailty; however, these attempts are complicated by the multidimensionality of the underlying causes of frailty, thus creating a dynamic, ever-changing value that is difficult to index (rockwood et al., ) . the term physical frailty has been applied to age-related loss of muscle mass and function, that is sarcopenia (detailed in the next section). in recent years, frailty research has increased rapidly in china as a strategy to prevent disability in response to an ageing population (chhetri et al., ) . research projects were showcased in the following scientific conferences: the st and nd international china conference on frailty in china, jointly organized by the who collaborating centre on frailty, clinical research and geriatric training at the gerontopole, toulouse, france, the chinese embassy in paris, and the national clinical centre for geriatric diseases, china, and the th asian conference for frailty and sarcopenia in dalian in october , organized by the chinese geriatrics society, beijing institute of geriatrics and gerontology and the chinese health promotion foundation. wide-ranging topics included basic science, epidemiology, definitions and measurements, management, as well as service models. such conferences greatly accelerate basic and clinical research on as well as clinical treatment for frailty. frailty may be used as a population indicator of ageing, and be a useful indicator of a need for treatment. research into prevalence, risk factors, prevention, and incorporation into service delivery models in community, hospital and residential care settings are an important part of the ageing research agenda for china. the importance of recognizing frailty in communitydwelling older people in china has been highlighted in a systematic review and meta-analysis by he et al. (he et al., a) . risk factors for a worsening in frailty among community-living older adults include hospitalizations, older age, previous stroke, lower cognitive function, diabetes and osteoarthritis, while higher socioeconomic status and neighborhood green space were protective factors (lee et al., ; yu et al., c) . a comparison of prevalence and incidence of frailty between populations may stimulate further research into prevention strategies and inform government policies. using data from a nationally representative study, wu et al. found that % of community-dwelling adults aged years or above were frail in mainland china and the prevalence increased dramatically with age, reaching . % for those aged years or above ). substantial regional disparities exist in the prevalence as well as incidence of frailty in mainland china. for example, the incidence rate of frailty in the northeast was more than double than that in the southeast . furthermore, a comparison of frailty and its contributory factors across three chinese populations (hong kong, urban and rural populations of taiwan) using the ratio of frailty index (fi) to life expectancy (le) as an indicator of compression of morbidity showed higher fi/le in taiwan compared with hong kong. risk factors include low physical activity and living alone . the importance of protein intake to slow the decline in muscle mass and physical function over four years supports the importance of nutrition as an underlying factor for physical frailty .the role of inflammatory cytokines in the pathophysiology of sarcopenia is supported by the finding of slower decline in grip strength for those in the highest quartile of telomere length (woo et al., b) . simple tools for frailty and sarcopenia may be used in a community setting as case finding, without the need for professionally trained personnel (woo et al., a; woo et al., b) . this may represent the first step in the approach to community-based intervention such as group exercises with or without nutritional supplementation for frailty and sarcopenia (yu et al., in press; . how community services may be developed to make frailty as a cornerstone of health and social care systems (woo, ) depends on the development of existing community infrastructures. two examples have been described previously: the tai po cadenza hub, and the jockey club e health project, where screening data based on the who integrated care for older people toolkit (who) were collected via ipad, followed by action algorithms for items where action is indicated: e.g., frailty, sarcopenia. this model emphasizes the empowerment of older people and their care-givers, societal-level behavioral changes, and the use of technology in the absence of a low cost primary care system orientated to meeting the needs of older people (woo, ) . in the hospital setting, detection of frailty may inform choice of therapies and prognosis, such as mortality and hospitalization in chronic heart failure . closely related to the concept of frailty, sarcopenia is an age-related gradual loss of mass and strength of skeletal muscles resulting in reduced physical performance. major pathological features include a loss of satellite cells and motor neurons, as well as less active neuromuscular junctions (cruz-jentoft et al., ) . following the publication of the european consensus group on sarcopenia (cruz-jentoft et al., ; cruz-jentoft et al., ) , an asian group including chinese researchers formed a panel to arrive at a consensus on the definition of sarcopenia, published in , and recently updated in . the asian criteria differed from the european consensus definitions. an individual international statistical classification of diseases and related health problems code (m . ) was assigned to 'sarcopenia' which has stimulated both diagnostic and therapeutic trials worldwide. in china, sarcopenia diagnosis requires some special considerations, including anthropometric and cultural differences. the guideline of asia working group of sarcopenia (awgs) provides updated guidelines on epidemiology, case-finding, the diagnostic algorithm, measurements of muscle mass, muscle strength and physical performance, and intervention and treatment. the prevalence of sarcopenia is estimated to be between . - . % among the general older population and was over % in the oldest populations ( +) wang et al., a; woo et al., a; xu et al., , in press; yu et al., ) . while old age is the primary risk factor for sarcopenia, other risk factors in the chinese population include household status, lifestyle, physical inactivity, poor nutritional and dental status, and some diseases (osteoporosis, metabolic diseases, etc.). in terms of longer-term clinical outcomes, awgs-defined sarcopenia was significantly associated with increased risks of physical limitations at years, slowness at years, and -year mortality, but not of hospitalization wang et al., a; woo et al., a; yu et al., ) . interventional strategies for the elderly of china have been the subject of recent research. for instance, an intervention for community-dwelling older adults yielded significant improvements in muscle function based on which when protein was offered as an oral nutritional supplement in combination with resistance exercises (kang et al., ) . similar findings were reported in j o u r n a l p r e -p r o o f major behavioral risk factors that are responsible for cncds are prevalent among the elderly in china. nearly % of deaths are attributable to unhealthy diet, high blood pressure, smoking, high glucose, air pollution (indoor and outdoor), and physical inactivity (who, ) . in china, . % of adults aged + have insufficient dietary balance (daily intake of < g fruit and vegetables), . % are current smokers, % use unclean fuel for cooking, % are physically inactive, and . % have harmful alcohol use (who, ) . risk factors for major cncds, particularly smoking and alcohol use, are unevenly distributed among older men and women. the prevalence of cigarette smoking is substantially higher among men ( . %) than women ( . %). the prevalence of harmful alcohol use among men is more than three times as much as that among women ( . % vs. %). substantial rural-urban disparities in the distribution of risk factors exist among older chinese adults. rural residents have a higher prevalence of smoking ( . % vs. . %), harmful alcohol use ( . % vs. . %), insufficient dietary intake ( % vs. . %), and unclean fuel use ( % vs. . %) than those in urban areas, while residents of urban areas have a substantially higher prevalence of physical inactivity than their rural counterparts. , cvd was ranked first in mortality rates, higher than the mortality rates attributed to tumors and other prevalent diseases. studies have shown that in , age-standardized cvd mortality in china was % lower than in (gbd, ; zhou et al., ) . although the age-standardized cvd mortality rate has declined, the absolute number of cvd deaths is still rising rapidly, and increased by % between and . cvd is a large burden for the chinese healthcare system. with the development of medical technology, and the government's focus on chronic disease management, the problem of cvd in china has improved. however, due to the problems arising from population ageing, cvd still has a great impact on national health. major factors for cvd include hypertension, dyslipidemia, diabetes, air pollution, and excess weight (overweight and obesity). some risk factors are specific to china compared to other countries, however, this is changing as china's economy develops and the population ages. hypertension is an important public health problem in china. the prevalence of hypertension in china among those over the age of is . %, and the number of patients with hypertension in china is estimated to be million . in , . million deaths were attributed to hypertension in china, accounting for . % of all causes of death (trammell et al., ) . with the rapid development of the economy and the ageing population, problems with blood lipid levels in china have gradually increased, and the prevalence of dyslipidemia has increased significantly. the main symptoms of dyslipidemia seen in china are low levels of low-density lipoprotein cholesterol (ldl-c) and hypertriglyceridemia (pan et al., ) , while dyslipidemia in the west is characterized by hypercholesterolemia and high levels of ldl-c (toth et al., ) . with the change of lifestyle following china's economic development, the number of chinese diabetic patients is growing. overall, % of adults in china have diabetes or pre-diabetes, which is slightly lower than the - % in the united states . in recent years, there has been a significant increase in the prevalence of excess weight (bmi: . - . kg/m ) and obesity (bmi≥ . kg/m ) in chinese residents, as noted over a five-year study period (he et al., b) . the prevalence of combined overweight and obesity among men was . %. air pollution is another important factor leading to cvd. among different particles, pm . (an aerodynamic diameter of . μm or less ) is most closely related to cvd (brook et al., ) . a follow-up study of cohorts of elderly people + in hong kong showed that for every μg /m increase in pm . concentration, the risk of total cvd death increased by % (wong et al., ) . air pollution is also associated with increased blood pressure. for each μg/m increase in pm . concentration, the per capita systolic blood pressure level increased by . mmhg, the per capita diastolic blood pressure level increased by . mmhg, and the risk of hypertension increases by % . coronary heart disease, atrial fibrillation (af), heart failure, and atherosclerosis are common forms of cvd. technological developments have allowed for an increase in treatment options and testing methods, including percutaneous coronary intervention (pci), radiofrequency ablation, implantable cardiac defibrillator (icd) and pacemaker implantation. since elderly patients are often associated with more complications, treatment decisions for cvd in elderly patients need to be adjusted individually based on an overall scoring of health. coronary heart disease is a common fatal cvd. for the treatment of coronary heart disease, the number of pci cases has steadily increased in china (zhao et al., b) . the creative study explored antiplatelet treatment options for patients after pci in china, and studies have shown that for patients with low response to antiplatelet drugs after pci, a triple antiplatelet intensive therapy combined with cilostazol is safe and effective (tang et al., ) . bleeding events should be paid special attention when administrating dual antiplatelet treatment to acs patients aged and older receiving pci (zhao et al., a) . the risk of all-cause, cardiovascular, and stroke deaths in patients with af is significantly higher than in patients with sinus rhythm . the proportion of chinese patients receiving anticoagulation treatments is low. only . % of patients with af and a chads score of or more received anticoagulation treatment . patients with af aged + tend to higher chads scores but receive less anticoagulation therapy. the risk of one-year follow-up deaths and adverse events in the elderly is more than doubled compared to other populations yang et al., ) . cases of af ablation procedures and icd implantation have steadily increased in china. however, european danish studies suggest that primary prevention through icd implantation has limited benefits in elderly patients with non-ischemic cardiac diseases (kober et al., ) . therefore, it is necessary to pay attention to the indications when expanding the population eligible for icd implantation in china. in recent years, the etiology of heart failure in china has changed significantly. the proportion of valvular disease (especially rheumatic valvular disease) has decreased. as china is becoming an ageing society, the number of elderly patients with heart failure has increased. at present, most studies suggest that coronary heart disease is a common cause of heart failure in the elderly, and the proportion of hypertension and pulmonary heart disease in elderly patients with heart failure increases with age. in recent years, the use of diuretics in hospitalized heart failure patients in china has not changed significantly, while the usage rate of digoxin has shown a downward trend. the use of acei, arb, aldosterone receptor antagonists and beta-blockers have shown a significant upward trend . lower extremity atherosclerotic disease (lead) is a common disease in the elderly and an important starting point for systemic atherosclerosis. early detection of lead is of great value in the diagnosis and treatment of systemic atherosclerosis (hiramoto et al., ) . to reduce the burden of cvd in china, we recommend interventions directed at altering lifestyles and programs dedicated to the detection and management of risk factors, especially for elderly people. research modeling has shown that if dyslipidemia and hypertension are effectively managed, medical expenses to the tone of $ billion us from - (stevens et al., ) . controlling blood lipids and blood pressure of elderly people over years of age represents the most cost-effective strategy (stevens et al., ) . mental health disorders, particularly dementia and depression, are major diseases in the elderly of china. alzheimer's disease international (adi) estimates that over million people worldwide were living with dementia in , and that this figure will rise to million by ; the current annual cost of dementia is estimated at trillion us dollars which will be doubled by (adi, ). it is estimated that the number of patients with dementia in china constitutes % of the dementia population worldwide, with the prevalence of dementia ranging from . % ( % ci . - . , in ) to . % ( % ci . - . , in ) for individuals aged + jia et al., ; jia et al., ) . the patterns and spread of dementia in china vary geographically and between genders. women are . times more susceptible than men. western china has a higher prevalence at . %, while central and northern china are lower at . and . %, respectively, southern china has the lowest prevalence at . %, this variation is possibly due to a variety of reasons including diet, exercise, social networks, healthcare, etc. (chan et al., ; jia et al., ; wu et al., b) . the incidence of dementia in individuals aged + ranged from . to . per person-years using / dementia research group criteria, while it was . per person-years using dsm-iv criteria (jia et al., ; prince et al., ; yuan et al., ) . while health conditions such as depression, diabetes mellitus, and insomnia correlate with dementia in a global fashion, epidemiological evidence from different regions in china also suggests smoking and heavy alcohol consumption as high risk factors (fan et al., ; pei et al., ; xue et al., ) . depression, a risk factor for dementia, is a common but often neglected disease in the elderly in china . data from a cross-sectional study suggest a prevalence of depression of % in the elderly which increases to % in the most elderly (yu et al., ) . in view of the stigma of mental illness in some areas of china coupled with inadequate health services in rural areas, depression is likely underdiagnosed suggesting the real prevalence may be higher. in addition to its contribution to dementia, depression aggravates the quality of life of the elderly and of their family members, brings the risk of death caused by different reasons, and accordingly is a heavy burden on the society and the healthcare system (zhang and li, ) . much effort should be made to address mental health disorders in china, including increasing government investment, the training of more geriatric care professionals with specialties in mental disorders, and raising public awareness, especially in conjunction with more active social activities and exercises. although there have been increased care facilities for citizens + and improved access to health services, the diagnosis and management of dementia and depression are still inadequate, especially in rural areas (jia et al., ) . the inclusion of steps to manage dementia in the th five-year plan of the central chinese government marked a major step forwards, and such efforts need to be continued. in view of the insufficiency of medical professionals in regards to mental disorders, especially in rural areas, we recommend increased training to such professionals, and the development of policies to encourage health professionals to work (at least for a short period) in rural areas . in recent years, the public awareness of mental disorders, especially ad, has greatly improved thanks to efforts from social media (e.g., drama shows on ad) and dementia organizations. professional interventions, comprising medicine and combined cognitivepsychological-physical intervention (e.g., family and community support plus playing mahjong and practicing taichi) can mitigate subclinical depression and improve overall mental health (kong et al., ; wang et al., c; wong et al., ) . although no drug at present is available to cure ad, recent progress on the understanding of ad etiology, such as the involvement of impaired mitophagy and reduced grid-cell-like representations in the human ad brain, along with the development of novel stem cell models, and the use of artificial intelligence (ai), will undoubtedly propel the development of novel drugs (fang, ; fang et al., ; gilmour et al., ; kunz et al., ; lin et al., ) . the china brain project, covering studies on basic neuroscience, brain diseases, and brain-inspired computing, will greatly benefit the development of novel drugs for different neurological diseases (poo et al., ) . while oral health is an important part of the whole body, the prevalence of oral disease is high in the elderly in china, but is largely ignored, while here we focus on dental health. dental caries (tooth decay), periodontal disease and tooth loss in the elderly are issues of global health concern. the burden on healthcare cost and the quality of life of these dental diseases in the elderly remain high . maintaining good dental health is an integral part of healthy ageing. as such, developing effective preventive and therapeutic interventions are needed to protect and enhance dental health and well-being tonetti et al., ) . dental caries and periodontal diseases are common oral diseases in the elderly and often lead to tooth loss, edentulism (toothlessness), impaired masticatory function and poor nutrition. according to the th national oral health epidemiological survey (fnohes, (fnohes, - covering the whole of mainland china, caries and periodontal diseases are highly prevalent in the elderly in china; while the prevalence of caries was above % in all age groups ( - , - , - , - , and - years) , the rate was % in the - years groups (lu et al., ; si et al., ) . in adults aged - years, . % had periodontal diseases, including gingival bleeding ( . %), dental calculus ( . %) and a deep periodontal pocket ( . %) (lu et al., ; si et al., ) . human oral tissues naturally and gradually degrade with age; a fact also exacerbated by modern lifestyle choices, including the prevalence of sugary diets and a lack of oral hygiene (belibasakis, ; lamster et al., ) . more specifically, age-dependent changes include a reduction in periodontal support, loss of elastic fibers, and thickening and disorganization of collagen bundles in the connective tissue of the oral mucosa (belibasakis, ; lamster et al., ; wu et al., b) . severe dental health challenges can cause loss of self-esteem, social difficulties, while also being drivers of common diseases, such as ad, pd, diabetes, and hypertension (belibasakis, ; bollero et al., ; dominy et al., ; lamster et al., ) . major risk factors of the high prevalence of dental diseases in the elderly in china include the scarcity of dental health knowledge in the general population, low frequency of daily oral hygiene practices, insufficiency of dental care services, and unhealthy diet habits. daily oral hygiene practices are effective for removing plaque and preventing gingivitis. the average awareness rate of dental health in the chinese elderly was . %, only . % of the elderly brush their teeth twice daily, and a mere . % used dental floss (lu et al., ; si et al., ; . increased attention to the dental health needs of an ageing population urgently requires combined efforts by relevant stakeholders (lu et al., ; si et al., ; tonetti et al., ; . specifically in the case of older adults, knowledge and competence in oral care, awareness of medical comorbidities and of medications relevant to oral care should all be strengthened. epidemiological surveillance and monitoring of oral diseases and oral healthrelated quality of life in the elderly is needed. oral self-care, access to treatments and preventive services and assuring the affordability of dental care are critical for oral health. looking after teeth and gums by brushing twice a day with fluoride toothpaste and cleaning with dental floss are effective in achieving a good oral health status. likewise, the control of risk factors, such as refraining from the frequent consumption of foods and drink high in sugar, and refraining from smoking, are also important. provisions to expand services to older adults, to meet increasing oral healthcare needs in the ageing population, and to ensure the affordability of dental care should all be emphasized by policymakers. we suggest programmes that promote general oral health education as well as public outreach programmes directed towards the elderly via understandable brochures, and the use of television and other social medias. additionally, it is important to improve the country's dental care infrastructure by training more dentists and oral specialists and ensuring the provision of affordable dental healthcare. it has been well documented that altered immune system components and function are characteristic of ageing and form part of the causes of age-related diseases (nikolich-zugich, ) . in ageing, a significant decline in the homeostatic, defensive, and surveillance functions of the immune system is noted. prominent features of the ageing immune system include thymus involution, a decrease in naïve lymphocytes, and an accumulation of memory and senescent lymphocytes; more recently, the concept of 'inflammageing' has been developed (ferrucci and fabbri, ) . functionally, impaired immune defense, especially against new antigens for which no memory exists, makes older adults increasingly vulnerable to incident and more severe infections. in addition, a decline in immune surveillance hampers the elimination of premalignant cells, leading to cancer development. older adults also manifest a chronic low-grade inflammatory phenotype (clip), a manifestation of the inflammageing concept, that likely results from uncompensated inhibitory immune regulation and/or an inability to eliminate senescent cells (chen and yung, ; chen et al., b) . as such, immune dysregulation is a general feature of ageing. here we provide an update on infectious diseases in the elderly in china. we carried out a comprehensive review on infections in china based on the following public databases: the chinese center for disease control and prevention (ccdc), the data-center of china public health science (ccdc, ), and the national bureau of statistics of china (nbsc, ). the three most common infectious diseases in were viral hepatitis, pulmonary tuberculosis (tb) and syphilis (detailed in section . ) while the three with the highest mortality rate were aids, tb, and viral hepatitis ( fig. a-d) . of note, pulmonary tb was more prevalent than the other two in older adults over years of age (fig. c ). generally speaking, infectious diseases are more frequent and deadly in older adults, as seen with the recent -ncov epidemic worldwide huang et al., ) ; thus, infectious diseases deserve more attention. viral hepatitis is caused by the hepatitis viruses a, b, c, d, and e (hav, hbv, hcv, hdv, hev) and is prevalent throughout the world, posing a significant threat to human health. china is a highly epidemic area of viral hepatitis with . million people infected with hbv and . million infected with hcvas of (who, . in , there were . million new cases and deaths among the chinese population (nbsc, ) . according to the chinese statutory infectious disease report, viral hepatitis mainly occurred in adults between to years old ( . %, fig. e ). its morbidity in older adults was estimated to be . % in ( fig. e ). however, compared with the morbidity, the mortality of viral hepatitis was higher ( . %) in the aged population ( fig. e ). from the survey, the morbidity and mortality rate of viral hepatitis have ranked in the top five for many years. the morbidity of viral hepatitis was stable in last decade, which is likely due to the wide usage of the hepatitis vaccine ( fig. g , h). however, the morbidity of hepatitis in the elderly continues to increase yearly. since most cases of viral hepatitis developed into chronic hepatitis, the lifespan extension seen in china has contributed to a higher number of elderly hepatitis cases. luckily, the mortality of hepatitis has declined in both the aged population and the population at large (fig. h ). among the five hepatitis viruses, hdv is rarely detected and is not discussed here. hcv ( . %) and hev ( . %) demonstrated high morbidity in the aged population (fig. f) . however, the highest mortality is caused by two acute types, hav ( %) and hev ( . %) (fig. f) , indicating a weakened immune responses against acute infection in the elderly. significantly, both the morbidity and mortality of hbv in the aged population were lowest among the four types ( fig. f ), further indicating the benefit of the hbv vaccine. however, prophylactic vaccines for hcv and other types of viral hepatitis are still lacking. for patients who have been infected, current treatments are still limited, especially for the elderly patients. one of the reasons for this is the lack of a long-term infection model for use in laboratory conditions (winer et al., ) . developing an elderly-representative model would be a useful tool for screening treatment options for those affected by hepatitis diseases. mycobacterium tuberculosis and is typically transmitted through coughs and sneezes. the lack of global tb control is the result of several factors, including hiv coinfection, limited vaccine efficacy, a lack of highly specific and sensitive diagnostic tests, and the rise of multidrug-resistant (mdr) and extensively drug-resistant (xdr) tb strains (venketaraman et al., ) . according to the who's global tuberculosis report, china is ranked third in terms of tb burden when compared with other countries (who, a). pulmonary tuberculosis (p-tb) is the second highest ranked cause of morbidity and mortality among the infectious diseases ranked in (fig. a, b) . however, it is the most frequent infectious disease in the elderly (fig. c ). the elderly occupied more than half ( . %) of all deaths from p-tb (fig. e ). in the last decade, the incidence of p-tb has decreased year to year, however, the incidence and mortality rates of p-tb in the elderly remains high in china (fig. g , f). there are several reasons for the high incidence and mortality rates of p-tb in the elderly: i) an increasingly ageing population; ii) immune decline; iii) delay of diagnosis and treatment. with the increase of the number of elderly patients, p-tb is rapidly becoming a new public health challenge. several risk factors, such as immune decline, smoking, malnutrition, hiv infection and other chronic diseases, make the elderly susceptible to tb . compared with p-tb in the young, p-tb in the elderly has its own characteristics. elderly patients with p-tb are more contagious than the young, and elderly men are more likely to suffer from tuberculosis than elderly women (lee et al., ) . in the elderly, early symptoms of tb are atypical and insidious, and can result in misdiagnosis (rajagopalan, ) . furthermore, chronic fibrous cavitation and hematogenous disseminated tb are more common in the elderly population. most elderly patients with p-tb get tb in their youth at which time it is better controlled but, as they age, p-tb can result as immune function declines. moreover, elderly tb patients usually present with several complications, which further complicates diagnosis and treatment (nagu et al., ) . all these characteristics have brought special focus on the treatment and diagnosis of tb in the elderly. at present, there are several tb guidelines for high-risk groups (who, b), but few for the elderly. previous studies in the elderly have also focused less on the evaluation of targeted strategies for control and prevention. thus it is necessary to pay more attention in the future to the production of control programs and evaluation of targeted interventions for tb in the elderly. aids is a chronic, potentially life-threatening infectious disease caused by hiv, which was first detected in the united states in ( barré-sinoussi et al., ) . in the last decade, the morbidity and mortality of hiv/aids has increased yearly ( fig. g, h) , and it has become the top cause of death by infectious disease in china, including in the elderly (fig. b, d) . the morbidity and mortality of hiv/aids in the elderly population is also rising significantly, and notably the mortality in the elderly is much higher than that seen in the young (ccdc, ). furthermore, because elderly people have many basic diseases and low awareness of selftesting after hiv infection, the elderly are more likely to already be aids patient at the time of diagnosis of their hiv infection (xing et al., ) . a study has shown that . % of newly diagnosed elderly hiv infectors had already developed into the aids stage (liu et al., ) . with increasing use and efficacy of antiretroviral therapy for hiv infection, the lifespan of hiv/aids patients has been greatly extended, and more and more hiv/aids patients will enter old age (nizami et al., ) . the problem of hiv/aids in the elderly will become increasingly serious in the future. firstly, hiv infection is not commonly checked in the elderly in china upon visit to the hospital, which may lead to uncontrolled disease progression and infection to others. second, the treatment of aged hiv/aids patients may cause more adverse effects, such as cardiovascular disease (hanna et al., ; kramer et al., ) , ad (brousseau et al., ) , and diabetes (guaraldi et al., ) . furthermore, cognitive disorders, loneliness, shame and depression may increase the likelihood that they fail to follow their drug regimen, or refuse treatment altogether (greene et al., ; vincent et al., ) . interestingly, hiv infection is also likely a driver of early ageing, as aids patients age more rapidly than the general healthy population (he et al., b; lin et al., ) . to address these problems, the diagnostic process in the aged population should be addressed more cautiously; therapeutic drugs and technologies suitable for the elderly patients should be developed. special attention should also be paid to psychological problems of elderly patients. the hiv epidemic as a sexually transmitted disease will be discussed further below. influenza is an acute viral infection caused by the influenza virus. at present, a total of four types of influenza viruses have been identified, including influenza a, b, c, and d (iav, ibv, icv and idv) (petrova and russell, ) . among them, only iav and ibv are able to cause seasonal epidemics and clinical disease. yearly, the extent of the influenza pandemic varies around the world, which causes high morbidity and mortality. because elderly individuals above years of age are immunocompromised and may have preexisting conditions, they are more susceptible to influenza infection and its complications. data accumulated in the last decade showed that the morbidity of influenza has increased in both the general and aged populations (fig. g ). like other acute infections, the mortality of influenza in aged patients was higher than in younger population (fig. h ). during january , to september , , a total of severe influenza cases were reported in hong kong, among which patients ( . %) were over years old (chp, b). in , a total of influenza cases were reported in macau, among which there were cases were over years (hbgm, a) . however, only a small number of influenza cases acquires laboratory confirmation, as patients usually die of other related illnesses brought on by influenza. thus, the influenza-related mortality rate is greatly underestimated. in , the ccdc estimated that the death rate caused by influenza was / in northern china and . / in southern china, and most of the deaths occurred among people aged over years ( . % in southern cities and . % in the northern) (feng et al., ) . the excess mortality of respiratory and circulatory diseases caused by influenza was . / and . / , respectively, among which % occurred in people aged over years (feng et al., ) . pneumonia is an acute respiratory infection that affects the lungs, which is especially deadly in children under years and in the elderly ( +). pneumonia has become one of the major causes of death for the elderly over years. the harm and mortality of pneumonia increases with age. the " china health statistics yearbook" reported that the mortality rate (/ ) of urban residents aged - , - , - , - , and over with pneumonia was . , . , . , . and . , respectively; and that of rural residents was . , . , . , . and . , respectively (nbsc, ) . since , pneumonia has been one of the top three causes of death in hong kong (chp, a) . according to statists by the hong kong centre for health protection, the mortality rate of pneumonia was / in , with a total of pneumonia-related deaths. of these cases, . % occurred in people aged over years (chp, c) . in macau, pneumonia also has been cited as one of the top three causes of death for many years (hbgm, b). in summary, old age is known to affect the immune system negatively. immunocompromised elderly adults are more susceptible to common diseases such as influenza and pneumonia, both of which were responsible for many deaths in this age group. in some cases, these infections may lead to complications that then lead to death, and this likely contributes to underreporting, hiding the true effects of influenza and pneumonia. there are multiple methods for improving and maintaining healthy immune function in the elderly: physical activity and exercise are known to enhance the immune system, however effective ranges still need to be established and disseminated (venjatraman and fernandes, ) . additionally, the development of vaccines must be prioritized, although challenges exist such as finding suitable mass production methods. perhaps surprisingly, sexually transmitted diseases (stds) are becoming an increasing problem among older age groups. many people aged years or older in china remain sexually active, and the shift towards nursing homes has led to an increase in exposure to possible sexual partners (yang and yan, ) . unfortunately, many older adults do not take precautions in their sex life, due to reasons such as a decreased worry about pregnancy (tht_uk, ) . high-risk sexual behaviors render them vulnerable to the transmission of hiv and other sexually transmitted diseases (stds), likewise low awareness of the potential risks and low use of sexual health services can result in late diagnosis and treatment of stds among older adults. we here describe the current situation of hiv/aids and other stds in older adults in china, and propose potential preventative measures. as mentioned before the incidence and proportion of older adults in the total number of reported hiv/aids cases is on the rise in china (fig. a-d) . the rise in both the number of absolute cases and the proportion of std infections was observed in both genders. the vast majority of cases in older adults resulted from heterosexual copulation, and has brought about an alarming increase in the rate of new infections. for example, in chongqing, the proportion of hiv infections reported in those aged years and older increased dramatically from to . % between and (chinanews, )at the same time, the overall number of male cases quadrupled, and the female cases tripled between - (wu, ) . among women newly diagnosed with hiv in china between - , the proportion of those aged years and older increased from . % in ( / ) to . % in ( / ) . this proportion is even higher in regions with larger rural populations. in guangxi, % of newly reported hiv cases in were men aged + (hu et al., a) . in addition to the increase in newly reported infection among older adults, people infected with hiv can now survive to an older age, increasing the proportion of advanced-age hiv cases. in addition to hiv other stds are increasing in prevalence among the elderly in china. from to , the incidence of syphilis in people over years of age increased by over %. the proportion of people aged years and older among all syphilis cases was also on the rise, from . % in to . % in . between - , the incidence of condyloma acuminate in china showed a downward trend, with an average annual decline of . %. however, the incidence rate among people aged and over increased by . % annually (yue et al., ) . gonorrhea is not common in the elderly, and china saw an average annual decline of . % in the incidence of gonorrhea. this trend was also seen in older adults ( . %- . %) (gong et al., ) . this phenomenon may be related to the short incubation period of gonorrhea, the high self-medication rate of patients, the sensitivity of gonococcal bacteria to antibiotics, and the insignificant clinical symptoms of female patients (wang and ni, ) . there are several contributing factors behind hiv/stds transmission in older adults. ageing is associated with various physiological changes in the human body collectively known as frailty. however, physiological changes in sexual function often fail to attract societal attention. male sexual dysfunction and disorders often manifest in the slowing of penile erection, prolonged ejaculation, the dampening of sexual desire, impotence, etc. as women age, their vaginal tissue becomes thinner, drier, and less likely to become fertile. for the above reasons, the use of condoms in the elderly seems to be less important. older women may have less interest in or need for sexual intercourse; however, their male counterparts may continue to be sexually active for a long period of time. cravings for sex combined with loneliness may push men to resort to commercial sex to quench their desire for sex. in rural areas, the hiv prevalence is high among street-based female sex workers and female sex workers working at sex-on-premise venues with low quality of hygiene, such as hairdressing shops. use of condoms and other precautions in these scenarios is likely to be lacking . sexual education in older adults is nearly absent, and it is generally assumed that "age is a condom". embarrassment may discourage older adults from obtaining condoms and other precautions. in a survey in guangxi, although . % of respondents were willing to accept condoms issued free of charge by healthcare services, . % of the respondents were unwilling to take them of their own due to embarrassment (qi and pang, ) . despite the growing importance of sexual health among older adults, many of them do not seek health services for sexual problems. in china, data on sexual health in older adults are scarce. existing research focuses mostly on males (jiang, ) . few actions have been taken to accommodate older adults' sexual health needs in china. engaging older adults in health program development and policy changes is particularly challenging due to concurrent incidences of disability, frailty, and other comorbidities. conventional top-down strategies are often unappealing and less trusted by the target audience. innovative solutions are needed to develop contextualized sexual health services and ensure that they are inclusive, trusted, and reliable. collectively, hiv/stds are becoming an increasing problem in the elderly in china due to diminished precautions in their sex life, a lack of condom usage, and insufficient sexual education, among other issues. future research focuses should include a) routine sexual healthcare and screening for hiv/stds among older adults, especially those who have highrisk sexual behaviors; b) sexual health education and hiv/stds prevention among older adults; c) late diagnosis of hiv/stds among older adults; and d) healthcare providers' attitude on the sexual health of older adults. modifiable health-related behaviors (hrbs) are key contributors to chronic diseases and early mortality, such that by maintaining a vigorous lifestyle, the processes of frailty, disability, and dementia can be postponed or even prevented (lafortune et al., ; rizzuto and fratiglioni, ; who, c) . similar public health recommendations for hrbs have been promoted worldwide, namely, refraining from smoking and excessive alcohol consumption, consuming a balanced diet, partaking in regular physical exercise, and maintaining frequent social engagements (who, d ). an international comparison study revealed a large degree of consistency in hrb clustering across six nationally-representative ageing cohorts in the east and west, alongside considerable gender-and country-specific variations (liao et al., b) . particularly, older chinese males were characterized by a much higher probability of being smokers ( %) than their counterparts in japan ( %), korea ( %), usa ( %), uk ( %), and in other european countries ( %~ %) (liao et al., b) . comparable findings have been reported in the who's report on the global tobacco epidemic, which further indicates that the progress of smoking reduction tends to be noticeably slower in china than the global average (who, d). nevertheless, positive developments of china's concerted tobacco control efforts, such as smoke-free public places, a strengthened ban on tobacco advertising, etc., should be acknowledged (li and galea, ) . these smoke-free movements have challenged and hope to gradually change social norms regarding smoking, though they may be less effective among older generations with poor health literacy (hu et al., ) . the implementation of the healthy china action plan provides an opportunity to increase tobacco control (li and galea, ) , as well as to address a range of risk factors via a population-based multi-sectoral approach (nhcprc, a) . aiming to enhance the overall health of the chinese population, the plan prioritizes major actions, including the promotion of health literacy, the improvement of nutrition, a new national exercise campaign, more tobacco control measures, the promotion of mental health and environmental health; and specific actions dedicated to four target populations (i.e. women and children, teenagers, older adults, and those undertaking special occupations) and five categories of diseases, i.e. cardiovascular and cerebrovascular diseases, cancer, respiratory diseases (e.g. copd), diabetes, and infectious diseases. besides health-related targets for the health promotion actions for older adults, the importance of building an elderly-friendly and engaging environment is highlighted, which embodies "ageing in place" with humane, equitable and sustainable health and social care resources. social engagement is a key determinant of active ageing (world health organization, ) , especially within china's collective cultural background (liao et al., b; liao et al., ) . in tandem with physical exercise, social activities may generate health benefits not only for the body but also for the soul. chinese square dancing is a social group-based exercise performed to music in public squares or parks. this low-cost and easy-participation activity is highly popular among middle-aged and retired chinese women, estimated at million participants in (fang, ) . square dancers can meet as often as every day, usually in the early morning or evening after dinner, and sometimes both, upon meeting they organize themselves into rank and file, and exercise for nearly two hours, led by the most proficient dancer (liao et al., a) . as an aerobic exercise accompanied by a dance rhythm, square dancing mobilizes the participants' whole body, improving their balance and cardiopulmonary function (liu and guo, ) . it is also cognitively challenging, requiring participants to listen to and process the music, focus on movement and balance, and dance to the rhythm with coordinated body movements (kattenstroth et al., ) . moreover, square dancing creates a socially enriched environment for participants to interact with peers, keeping them socially engaged and dispelling loneliness (liao et al., a; liao et al., ) . square dancing is a typical example of a grassroots group activity that may serve as inspiration for the design of culturally appropriate health promotion programs for older adults. one possibility is developing similar programs that can be implemented throughout the country, and possibly tailoring them to the local needs and/or cultures. in the past five years, central and local governments in china have made enormous efforts in establishing a multi-dimensional geriatric care system to support healthy ageing in chinese society. more than national policies have been issued to drive the development of this care system, including cross-ministerial policy measures for promoting the growth of elderly services and the integrated development of medical, health and elderly care, through the guiding opinions on advancing the development of age-friendly livable environment (ndrc, ) , and the state council opinions on promoting the development of elderly care services (nhcprc, b, c) . following the strategies of the national -year plan, provincial and municipal governments have all issued local implementation plans. in places such as shanghai, shandong, jiangsu, zhejiang and guangdong, political will has been accompanied by strong financial support (cnca, ). as compared to q , in q there was an additional . million beds added in public and private nursing homes across china, resulting in a total national supply of . million beds (mcaprc, a, b) . in , the ministry of civil affairs allocated rmb . billion (usd million) to support the local expansion of care beds in nursing homes as well as the development of community and home care services. in terms of service utilization, the occupancy rate of nursing home beds is at around %, i.e. at any time, there are less than . million residents in these facilities. , elderly benefited from nursing care subsidies while . million benefited from social care subsidies (mcaprc, a, b) . in july , the first national pilot of a long-term care insurance (ltci) program was announced in cities across different regions of china (mhrssprc, ) . identification of elderly people with severe care dependency was carried out, and local models of financing care for them in nursing homes, community centers as well as at home were implemented. by june this pilot program covered a total of . million people, funding services for , beneficiaries at rmb , per year per person (nhsaprc, ). while geriatric care system development has attracted strong attention from stakeholders and become a major theme for policy, research and investment, the following challenges need to be understood and addressed before meaningful progress can be made to prepare the country for its rapid entrance into an ageing society. the first challenge is that care needs must be assessed comprehensively and should be subject to regular reassessment in order to develop personalized care plans and identify goals that are aligned among care recipients, providers and payers (who, ) . generally, there are currently two types of assessments in use in china: one conducted before admission into nursing homes, the other for entry into the ltci programs. the first type can be quite comprehensive but is often used to decide the charge levels associated with the care service. the second type uses a simple -item adl questionnaire and links its results to the funding schemes, e.g. maximum hours of care per month. as the assessment of care needs tends to be one-off and disconnected to care plans or goals (hua, ; ma, ) , it is difficult to allocate resources dynamically and to analyze care performance or economics. the second challenge involves problems with service capacity. on the one hand, % of nursing home beds are left unoccupied and, contrary to international best practice, for the beds that are occupied, only less than % are actually utilized by people with severe dependency; on the other hand, according to the national health commission, nearly million seniors have chronic diseases, and million have various levels of disabilities (nhcprc, b, c) . among the over million people with different degrees of care dependency and care needs, under % have been served by community and home, and the majority have yet to be cared for (mcaprc, a, b) . some policies have been put in place to attempt to fill the huge gap in caregivers, stating that million more caregivers are needed just to care for the existing group of dependent seniors. however, if the current mainstream model of "replacive care" is not changed, growing care service capacity will only lead to an accelerated rate of care dependency among the high-risk population. additionally, such a model of care is highly unattractive to potential workforce candidates. as a corrective move, the central government has now set a goal to train million more caregivers by (mcaprc, a, b) . the third challenge is distorted allocation of resources. up until the end of , despite plans to establish a home care-dominant, community-backed and nursing home-supplemented system, investment has remained predominantly in heavy assets, i.e. the development of nursing homes as well as senior-living property projects, resulting in the above-mentioned "oversupply" of care beds (qiao, ) . since the th five-year plan, the central government has committed to an annual funding of rmb billion to support innovative pilots of home-or community-based care models (mcaprc, (mcaprc, - . however, for many local governments, the first and foremost priority when developing local care capacity is to specify land for elderly care use and invest in care facilities construction before or while looking for operators of such facilities. in addition to resistance and reluctance from nursing homes and preexisting policymakers, difficulty in understanding senior population's care needs and evaluating care competency among community and home care providers have prevented financial support schemes from materializing in most parts of china. typical examples of the insufficient support for community and home care service development can be seen in the number of government purchase tenders that fell through without enough qualified bidders. while there is no lack of political will and resources to be invested in further developing the care system, there is an urgent need to pay for access and quality. a value-based resource allocation model focusing on improving population health rather than the current fee-for-service care model would provide china a rare opportunity to benefit from a healthily ageing society (gyurmey and kwiatkowski, ; mandal et al., ) . to address the above-mentioned challenges and seize the opportunity associated with them, pilots should be designed based on local evidence and should be established in four dimensions. firstly, development of care plans should be focused on individually centered goal based on comprehensive assessments. as highlighted in the latest who icope (integrated care for older persons) package, it is essential for countries and health systems to align the efforts of different stakeholders with a shared care plan that is customized to serve the individuals' priorities and goals. secondly, health and social care resources should be integrated to support the realization of personalized goals of care and, at the population level, to delay and reduce care dependency. rather than further developing passive care capacity to compensate for the increasing need for other fragmented services, devoting resources to the reaching of a consensus among care providers and receivers will serve to empower the population itself, and maximize the pooling of financial and human resources, decreasing the need for an expansion of passive services (who, b). thirdly, the education and training of "integrated care managers" should be developed, whose job would be to work actively in primary care settings to identify care needs and coordinate care resources crucial to achieving societal and individual care goals. mobilizing talents with various backgrounds to understand and operate under the comprehensiveness of geriatric health needs, developing their capability to better communicate and coordinate care efforts across public and private sectors would not only facility the integration of various care services, but make the care work more attractive for those seeking long-term career opportunities (wang and song, ) . fourthly, a reform of the payment model used in elderly care services should be carried out, focusing on value rather than volume of care for populations at risk of care dependency. healthcare payments have long been moving from an inefficient, fragmented, fee-for-service model to a value-based capitation or bundled payment model. for geriatric care financing, this reform is likely to develop faster than the reform of payments for healthcare services. setting sustainable goals for care and allocating resources accordingly will be a viable realistic solution to caring for the millions of chinese citizens in need . we recognize the complexity of establishing such a health-oriented care system. for the four dimensions of an integrated care system to be aligned around common goals as discussed above, a pre-requisite should be the interconnectivity of data: linking results across personal health records, assessments of geriatric care needs, and total costs of care, including: social and commercial health insurance payment, out-of-pocket private payment, social welfare payment, as well as other sources of funding for elderly care (threapleton et al., ) . palliative care is emerging as a new alternative for hospitalized elderly with life-threatening illness. the who defines palliative care as the prevention and relief of suffering of adult and pediatric patients and their families facing the problems associated with life-threatening illness (including malignant and non-malignant diseases). these problems include physical, psychological, social and spiritual suffering of both patients and their family members the aim of palliative care is to enhance the quality of life, promote dignity and comfort, and may also positively influence the course of illness (who, a). palliative care is the basic skill of medical staff in departments where medical care is provided to end-stage patients (e.g. icus, emergency rooms, geriatric and oncology departments) (ning, ) . the quality of death index survey showed that the death quality of mainland china ranked st out of countries, while taiwan and hong kong ranked th and nd , respectively (eiu, ) . while palliative care is widely available in western countries, it is limited in mainland china. according to a report in , only . % ( / , ) of hospitals offered palliative care services. in china, the proportion of course in palliative medicine at medical schools is relatively low and, often only available as electives for undergraduates or postgraduates (liu and yuan, ) . questionnaire data of th year medical students in and of geriatric nurses in , showed that . % of medical students and . % of nurses had no training or education regarding death or terminal care, and % of medical students and . % of nurses had not received any education about hospice and palliative care. thus the need for course education in hospice and palliative care at chinese medical schools is extremely urgent. palliative care is recommended to be introduced early in curative treatments when patients are diagnosed with a life-limiting disease or when the palliative care needs of patients are identified. current palliative care in mainland china is still mainly focused on patients with cancer, with only a few palliative care resources available for other chronic conditions such as copd, hiv and renal failure . therefore, in the future, palliative care should be extended to both patients with cancer, with other life-limiting diseases, and their families. many palliative care guidelines have emphasized that the discussion of advanced decisionmaking among patients and their families should be initiated when patients still possess decision-making capacity (cheng, ) . patients in mainland china sometimes fail to grasp or accept the truth of a diagnosis and limited survival time (cheng, ) . moreover, according to questionnaire reports from , patients in , awareness of the concept of advance care planning or advance directives in china is still low (kang et al., ) . in mainland china, family members are often held responsible for making decisions for the elderly in their care, despite a lack of knowledge or training, and thus may resort to homeopathic remedies. healthcare professionals generally have to ''respect'' any decision made by the families and try their best to ''save'' patients' lives using many life-sustaining treatments, although they generally hold negative attitudes to useless treatments. such an approach is regarded as an appropriate measure in terms of protecting themselves from medical conflicts. misunderstanding of palliative care as 'giving up on treatment and waiting for the death of the patients' by family members of the patients as well as even by some doctors, should be corrected (hu et al., b; ning, ; xiao et al., ) . there is an urgent need for the development of hospice and palliative care in china. in recent years, hospice and palliative care have witnessed rapid development. more and more patients, families, and health-care professionals come into contact with the concept and realize the benefit of hospice and palliative care, while more and more educators, organizations, government and other intermediary leaders have paid more attention to the promotion and development of hospice and palliative care. the current trend towards an ageing society poses difficulties due to the additional challenges seen in diseases in the elderly, including longer disease durations, more complications, underwhelming responses to treatment, and poor prognosis, thus in response to this trend, china has established the national clinical research center for geriatric disorders (ncrcgd) (o'meara, ; yu et al., a) . funded by the central government, the ncrcgd aims to provide innovative models for the diagnosis, management and further research into geriatric diseases at a national level. the ncrcgd focuses mainly on comprehensive and systematic research into pathogenesis, prevention, diagnosis and treatment of age-related diseases such as ad, pd, and cerebrovascular disease (xwhosp, b, ). at the same time, it is committed to building a national elderly medical service network and scientific innovation system by integrating resources of clinical and basic research. for instance, a health data management platform for the elderly could provide a scientific basis for management and decision making. furthermore, through the education and promotion of new theories and technologies of geriatrics to grassroots hospitals, the ncrcgd can build a better medical service system, improving the health of elderly people. the ncrcgd strives to promote the combination of academic and clinical research (xwhosp, b, ). research on agerelated diseases has been carried on such various aspects as diagnosis, treatment, and prevention in fields such as immunology and molecular biology (o'meara, ). the characterization of the gene pool, a series of research findings and new technologies have been applied at the clinic, which promotes the development of gerontology in the direction of precision medicine for early diagnosis, early prevention, and early treatment. the ncrcgd also serves as an educational harbor to foster the training of geriatricians and promote academic exchange (frailty-china, ; xwhosp, b, ). the organization also undertakes other social responsibilities, including partnerships with hundreds of institutions across the country, relying on their collaborative research network to successfully carry out a comprehensive assessment of multiple systems for the elderly (xwhosp, a). through a comprehensive assessment of the multiple aspects of the elderly's diseases, fitness, cognition, psychology and society, it may be possible to develop a system for early identification of health imbalances in the elderly that characterize certain diseases, aiding in their early prevention, and helping to reduce the burden of the ageing chinese society, as well as improving the elderly health service system. prospectively, the ncrcgd will also play its essential role in guiding the research and clinical guidelines for elderly people care as well as making more contributions to improve elderly people's quality of life in china. in order to deal with the ongoing boom in the elderly population, the chinese government has put more effort into funding research on ageing and its related diseases in recent decades. during the recent ( ) outbreak of coronavirus in china, older patients with preexisting ageing-related diseases were found to have a much higher casualty rates than younger patients (chen n et al, ) , again highlighting the importance of preventing ageing-related diseases. in response to this, along with the growing need for improving the quality of life of the elderly in china, more attention has been placed on the development of pharmacological strategies against ageing, organ degeneration and major ageing-related diseases. in this section, we will discuss recent world-wide progress in pharmacological attempts to improve healthspan, and the significant contributions that chinese researchers have made. calorie restriction (cr) was first demonstrated as an effective way to extend lifespan in rodents (de cabo and mattson, ), however the physiological mechanisms behind its anti-ageing effectiveness were not fully understood at the time, and remain uncertain. later studies have suggested that cr might extend lifespan by regulating insulin-like growth factor (igf) and mammalian target of rapamycin (mtor) pathways. metformin is primarily known for treating type diabetes, with its underlying molecular mechanisms leading to the to down-regulation of igf- signaling, and the inhibition of cellular proliferation, mitochondrial biogenesis, ros production, dna damage, activity of the mtor pathway, etc. . the anti-ageing effect of metformin is under investigation by the tame (targeting ageing with metformin) trial in the usa. acarbose, an antidiabetic drug, could also disrupt the igf pathway. acarbose has been shown to partially mimic the effects of cr and extend lifespan in mice by controlling blood sugar and slowing carbohydrate digestion (harrison et al., ) . a clinical trial on acarbose (clinicaltrials.gov identifier: nct ), named study of acarbose in longevity (sail), is in phase , and will hopefully shed some light on its pro-longevity effect in humans. mtor is a pivotal nutrition sensor that links cellular metabolism with proliferation, growth and survival by regulating amino acid metabolism, proteostasis, mitochondria dynamics, cellular senescence, etc. (liu and sabatini, ) . rapamycin, a well-known inhibitor of mtor, has shown life-extending effects in all model organisms and postpones the onset of age-associated diseases harrison et al., ; liu and sabatini, ) . despite the promising pro-longevity outcome of using rapamycin in animals, its clinical application in human has been obstructed by growing concern of potential side effects from immunosuppression and hyperglycemia (pallet and legendre, ) . whether the dosage can be fine-tuned to avoid these side effects will be the determining factor in whether or not rapamycin becomes a future pro-longevity drug. the application of induced pluripotent stem cells (ipscs) from healthy and pathological ageing individuals (liu et al., ) is also propelling further mechanistic studies and translational applications for cr. nicotinamide adenine dinucleotide (nad + ) is a fundamental molecule in human life and health; while there is an age-dependent reduction of nad + , nad + augmentation extends lifespan and improves healthspan in different animal models as well as shows potential to treat different neurodegenerative diseases based on phase i clinical trials (gilmour et al., ; lautrup et al., ; yoshino et al., ) . nad + precursors such as nicotinamide riboside (nr) and nicotinamide mononucleotide (nmn) have emerged as promising approaches for intervention against ageing phenotypes and age-related diseases. supplementation via these precursors can elevate nad + level in vivo and improve glucose metabolism, mitochondria biogenesis, dna repair, neovascularization and neuroprotection . additionally, more than five phase i clinical trials indicate that orally taking nr is well tolerated and able to elevate nad + in the blood (gilmour et al., ; lautrup et al., ) . several clinical trials are currently operating in parallel, investigating nr's effects on metabolic function in bones (nct ), in immunity (nct ), and nmn's effect in cardiometabolic function (nct ), with others also ongoing. in china, although nad + precursors have become widely available commercially as supplements, clinical trials exploring their disease-treating ability in humans are still lacking. senescent cells accumulate in aged tissues and this accumulation is considered one of the driving forces of ageing. senolytics are a class of molecules specifically designed to induce apoptosis of these senescent cells. clearing senescent cells in mice has been shown to substantially alleviate ageing phenotypes, producing potent therapeutic effects in ageingrelated diseases such as ad (bussian et al., ; zhang et al., b) , atherosclerosis (childs et al., ) and osteoarthritis (jeon et al., ) . in , a joint research team of chinese and american researchers found that the molecule abt reduced irradiationinduced senescent bone marrow hematopoietic stem cells (hscs) and muscle stem cells (muscs) in mice . abt (a bcl- family inhibitor), together with dasatinib (an anticancer drug) and quercetin (an apoptosis inducer) are the most commonly used senolytic drugs. the senolytic cocktail of dasatinib plus quercetin (dq) decreased naturally occurring senescent cells, improved mobility and reduced the risk of mortality . however, a small pilot clinical study using the same dq cocktail in patients with idiopathic pulmonary fibrosis (ipf) reported no change in pulmonary function, frailty index, clinical chemistries and reported health, though the beneficial effects on mobility were still noted (justice et al., ) . while clinical trials on senolytic drugs are mainly conducted in the usa, the concept of reducing senescent cells to delay the ageing progress has attracted interest from all over the world. since , the national natural science foundation of china (nsfc) has set up special programs, providing millions of rmb to support research on cellular senescence and organ degeneration. as such, it is recommended that china further expand its investment in senolytics research. targeting the microbiota may also improve age-related diseases, including ad. in , china approved the first domestically invented ad drug, oligomannate (gv- ) (wang et al., d) . considering there has been no new approved anti-ad drugs in the past years, this has been exciting news. despite the potential of these advances, more work is necessary to understand how gv- works. additionally, due to the relatively short clinical trial period, further investigation with longer lasting trials is highly recommended. most human trials for potential anti-ageing drug candidates are conducted in patients with certain age-related diseases. despite partial overlap of the pathologies of these diseases, the knowledge from these trials cannot be interpreted as treating ageing itself. therefore, to reach the goal of identifying anti-ageing compounds, a more comprehensive study on disease-free, healthily ageing groups with no obvious health issues is in immediate need. china has the advantage of a large and diverse population, providing an ideal subject pool for this type of study. the knowledge gained from such studies would likely open new avenues to better understand the fundamental aspects of ageing mechanisms, facilitating their treatment. from a public health and policy perspective, it can be seen that continuing research into prevention and management strategies will be important for both non-communicable diseases as well as geriatric syndromes, to ensure that it is not only life expectancy that is increased, but also the quality of life, by promoting independence and reducing reliance on elderly care services. regular monitoring of trends in incidence and case fatalities of common chronic diseases would enable estimates of future disease burdens and guide preventive health policies (chau et al., a; chau et al., b) . in addition, solutions to trends in the occurrence of disability and frailty are also needed (yu et al., b) . such data would inform the design of elder-friendly service delivery models across the whole spectrum, from prevention to primary care, hospital and residential care settings (woo et al., ; yu et al., ) . currently, hong kong, a special administrative region (sar) of china, has the longest life expectancies in the world for both men and women, such that the need to redesign service models is particularly pressing. by , it is predicted that % of the population in hong kong will be aged years and over; % will have at least one chronic condition, with an increasing prevalence of disability also predicted (yeoh and lai, ) . while the health and social care systems are well developed, there is a mismatch of needs as those with chronic conditions are predominantly managed in the public hospital systems, whereas primary care is predominantly in the private sector. a recent review concluded that better integration of health and social care systems with a primary emphasis on the community could be the best way forward for the ageing population in hong kong (threapleton et al., ) , exemplified by the formation of nurse-led district health centers in (fhb, ). other community models with an emphasis on promoting group activities to prevent frailty and aid selfmanagement of chronic diseases have also been developed (cadenza). such developments have the potential to enhance the role of primary healthcare professionals in preventing functional decline (morley et al., ) , so that many can retain independence even as life expectancy increases. the who's integrated care for older people (icope), formally launched in october , will form a useful blueprint for policymakers to build on their existing health and social care infrastructure (who, c). experiences of elderly healthcare in the european union (eu) may provide useful tips for the situation in china (table ). in the eu, elderly care is provided in each country based on its own social security system and cultural norms. in most european countries, the family and the state are the main providers of support to older people both in activities of daily living (adl) and in instrumental activities of daily living (iadl) (schmid et al., ) . europe is characterized by three types of care provision: ) 'crowding out', whereby the state largely replaces family care; ) 'crowding in', whereby the state promotes family care; ) 'mixed responsibility', whereby both the state and the family take a joint responsibility for care, yet have separate functions (brandt et al., ) . in china, family is still the traditional provider for elderly care (wu et al., a) . under current national and social developmental conditions of china, the chinese government encourages a ' / / ' pattern of eldercare system, namely: % of all older people are cared for at home, % are cared for in communities, and % are cared for in institutions (mayston et al., ) . a 'crowd out' system dominates in the nordic countries (denmark, finland, norway, sweden, iceland) , where the government strives to create a comprehensive system of care services in order to reduce the care obligation of the family. in continental european countries such as austria, belgium, france, germany and the netherlands, systems are more mixed in their provision of elderly care, though tend towards a 'crowd out' approach (kasearu and kutsar, ) . in the island countries, i.e. the uk and ireland, the system is more mixed, and the private market is the dominant welfare provider, with the government providing two main social care services to older people, one being old age pensions and the other being healthcare . southern european countries (e.g. greece, italy, portugal, spain) have a 'crowd in' system whereby families have more responsibilities for care services to older people (kasearu and kutsar, ; wu et al., ) . eastern european countries have undergone dramatic political, social and economic changes after the soviet era and experienced a rapid change from 'crowd out' to a 'crowd in' system where family is the main care provider and the government provides basic formal care services (kasearu and kutsar, ; wu et al., ) . in china, owing to confucian culture and its emphasis on the family, it is taken for granted that the family, most notably adult children, has the responsibility to care for older parents, especially in the rural areas of china, thus older people rely mainly on their children or family for support (chen and silverstein, ; wu et al., a) . rapid demographic ageing increases the demand for care in all ageing societies. currently, european countries face the enormous challenge of implementing major reforms to elderly care in order to ensure that the needs of older people can be continuously met in the future (brandt et al., ; broese van groenou and de boer, ) . to this end, european governments have increasingly relied on informal care in addition to regular and traditional formal care providers from professional home care services, day care units and nursing homes (broese van groenou and de boer, ; verbakel et al., ) . informal care for older people is generally provided by caregivers from both kin and non-kin groups, including spouses, children, relatives, neighbors, friends, etc. (swinkels et al., ) . in europe, around a third of people aged years or older provide informal care to older people. however, shrinking family sizes, the increasing participation of females in the workplace, and rising retirement ages, may pose a drastic challenge to informal care in the future (verbakel et al., ) . china is currently facing challenges in its family-based elderly care model due to new family formation, the spread of individualistic values, and frequent internal migration from rural to urban areas encouraged by rapid economic development (wu et al., a) . moreover, china's one-child policy has sped up the process of population ageing by accelerating the change of the fertility rate and, in turn, has weakened the family-based elderly care model in china . in europe, new elderly care arrangements have been gradually developing based on a new combination of family obligations, market provision and public support. in nordic countries, the state, family and market have been changing with regards to their roles in the provision of elderly care, specifically by increasing the provision of publicly funded care services in a forprofit capacity (marketization of elderly care) and increasing the importance of family care (szebehely and meagher, ) . in estonia, the idea of community-based support for older people has been increasingly set forth in order to postpone the need for institutional eldercare (tulva et al., ) (tulva et al., ) . when it comes to the current trend of eldercare in china, marketization has also been discussed to a large extent both at academic and policy levels. the 'public-private-partnership' (ppp) model may improve the efficiency of familybased eldercare. in the th five-year plan for national economic and social development ( - ) , the opening-up of the market for elderly care services (e.g. purchase of services by the government) was clearly stated (du and wang, ) . elderly care reforms might create new challenges for both europe and china, an important challenge being an increase in inequality in eldercare service utilization among different social groups of older people. older people with higher socioeconomic status will be able purchase private care services whereas those with less social capital will have to rely on more family-based care. in addition, for the chinese government, there is a need to take into account larger inequalities derived from immense resource variations across regions during the development and reform of elderly care services. while mainland china can learn many successful experiences from hong kong, the eu, etc., there remains many unique features that demand the creation of an elderly care system tailored to mainland china. in addition to responding to changes and preparing to adapt to an ageing society at the societal and individual levels, understanding of the mystery of ageing at a molecular level will aid the development of novel strategies to slow ageing and to promote healthy longevity. in the below sub-sections, we will focus on how to use centenarians, the china national genebank database (cngbdb), and ai to further propel ageing research. in china, the numbers of the oldest-old individuals (those aged +), near-centenarians ( +), and centenarians are increasing at roughly % yearly (fig. a-b) , providing unique resources for both basic research and clinical studies. there were , centenarians in , with the number rising to , by (abida and gu, ) . based on the un's medium variant projection, by over a quarter of the global oldest-old population will live in china. as the numbers of the most elderly have expanded, the gender structure of centenarians, the proportion from urban and rural areas, and differences in geographical distribution have formed "three-high" trends in china (data from china's population census, excluding hong kong, macau and taiwan) . first, there is a gender difference, with % of centenarians being female (peng, ) (fig. a) . data from the th population census of china ( ) reported , ( . %) female and , ( . %) male centenarians. this could be due to both physiological (e.g., female hormone estrogen) and cultural differences (women often do more housework, pay more attention to healthcare) (austad and fischer, ; peng, ) . second, urban and rural disparities were clear, wherein more centenarians ( %) live in rural areas, possibly due to a healthier living environment, diet and lifestyle in these regions (cai, ; peng, ; zeng et al., a) (fig. c ). and third, there was geographical difference in the distribution of centenarians. the distribution of longevity areas in china presents several significant characteristics, including province-specific: being majorly in hainan, guangxi, sichuan, yunnan, guangdong and xinjiang, and mostly distributed along river basins, with more centenarians along the pearl and yangtze rivers and the lancang river basins. these characteristics of the area distribution of centenarian suggest that areas beneficial to longevity can be divided into two types: 'natural' and 'economically developed' longevity areas (he et al., ; zeng et al., a) (fig. d) . studies of centenarians can provide valuable information for early prevention of major diseases, premature ageing, and early death, thus providing the scientific support necessary to cope with the quickly approaching arrival of an ageing society in china. centenarians may represent a prototype of successful ageing. a longitudinal study of a danish cohort suggests exceptional longevity does not result in excessive levels of disability (christensen et al., ) . in fact, some centenarians experience a delayed onset of age-related illnesses (delayers), whereas others did not succumb to any age-related illnesses (escapers) (christensen et al., ; hitt et al., ) . in addition, one case-control study showed that older individuals had a delayed age of onset of cancer, cardiovascular disease, diabetes mellitus, hypertension and osteoporosis than their respective younger reference groups (ismail et al., ) . the china hainan centenarian cohort study (chccs) on , centenarians is now in progress, focusing primarily on examining biological indicators and medical aspects, and extensively examining psychological and sociological factors (he et al., ) . all in all, the study of centenarians is a topic of immense importance for population and health policymakers, as well as for the larger aim to achieve long, healthy lives. state-of-the-art technologies enable the 'big data'-based investigation of the molecular mechanisms of human ageing and its associated diseases, providing unique information for therapies and interventions. the cngbdb is a centralized 'big data' hub of biological data, providing data sharing, knowledge search, computational analysis, management authorization, and visualization services to the global research community. built and maintained by the china national genebank (cngb), cngbdb draws from "banks": the living biobank, the biorepository, and the bioinformatics center, and from "platforms": the digitization platform and the synthesis and editing platform. the research data system of cngbdb integrates molecular data from internal and external sources into nine sub-databases including literature, gene, variation, protein, sequence, project, sample, experiment, and assembly (https://db.cngb.org/news/ /). comparative analyses of species and tissues can identify the molecular causes of ageing phenotypes, corroborate or disprove theories on ageing, and help to understand differences in j o u r n a l p r e -p r o o f the mechanisms of ageing across species. genotype comparisons within a species at the level of individuals and populations can help identify genetic reason for differences in lifespan. this approach may be used to compare populations from different regions of china, or chinese and foreign populations, such as ashkenazi jews and okinawan centenarians in japan, two populations well-known for their longevity, facilitating the discovery of chinese-specific agemodifying genes. the identification of potential life-extending genes eases the design of therapeutics that can mimic the effect of these genes in people without those genes. likewise, treatments can be designed for age-related diseases that result from mutated or nonfunctional genes in specific populations. it is also possible to comparatively analyze gene expression at the tissue level, as tissues age at different speeds. since many age-related diseases, such as ad, occur within a specific tissue, understanding the speed at which tissues age can help chinese gerontologists assess the risk of and help to prevent tissue-specific age-related diseases (wieser et al., ) . the advent of 'big data' and machine learning have eased the collection and identification of biomarkers associated with biological age and may allow for the development of personalized clinical diagnostic tools for physicians in the near future (aman et al., ) . in the field of medicine, biomarkers refer to measurable indices capable of identifying a condition, state of being, disease, or environmental marker whose presence may reflect a pathophysiological state (naylor, ) . the use of biomarkers has been applied to the field of anti-ageing technologies, including the prevention and treatment of age-related disease, and has been used to explore methods to delay or offset the ageing process altogether, and will likely serve as key components to advances in the field (campisi et al., ) . in some cases biomarkers may more accurately represent a patient's 'biological age', as opposed to a patient's simple 'chronological age', the former of which is thought to be more clinically relevant (lopez-otin et al., ) . the following sections will review three applications of biomarkers at the molecular, individual and societal levels, including current findings as well as potential research directions. as stated above, there are multiple tests that can be used to obtain molecular biomarkers, and several have been validated to some degree by current research. molecular biomarker studies can be roughly separated into classes: smaller scale studies attempting to determine the utility of a given biomarker, and machine learning studies involving thousands of samples with the intention of developing clinical assessment tools. as an example of this, a recent study involving elderly hypertensive patients was used to investigate a wide library of potentially useful biomarkers . here, elderly chinese participants were matched with subjects from a pool of , normal volunteers. after adjusting for confounding covariate factors, the researchers found that only elevated triglyceride levels were strongly linked to high blood pressure (hong et al., ) . while these cross-sectional studies are certainly important for determining which biomarkers should be considered for clinical evaluation, one of the limitations, at least in comparison to machine learning studies, is that they have a low number of samples. in the above examples, most participant groups contained less than people. while this is a surplus number in other medical contexts, one of the advantages of machine learning is its ability to process thousands of samples granting increased accuracy. fittingly, one of its primary uses is to draw meaningful conclusions from mass, simple, cheap, and non-invasive tests. another key limitation is that biomarker assessment studies using these 'smaller' cohorts tend to lack any external validation. perhaps one of the most easily accessible tests that comes to mind is a standard blood test, here the usefulness of machine learning has been demonstrated by putin and colleagues, who designed a modular ensemble of deep neural networks (dnns) of varying depth, structure and optimization for the prediction of human chronological age using a basic blood test (putin et al., ) . the team trained the dnns using a collection of over , samples from routine blood biochemistry and cell counting assays. the researchers reported that the accuracy of their results provided evidence to suggest that machine learning algorithms could be used to design minimally invasive biomarker tracking methods for ageing that would only improve with greater access to training samples (putin et al., ) . another study examined serum biomarkers, and its results were externally validated using a separate data set from the framingham heart study (sebastiani et al., ) . such studies highlight the ability of machine learning techniques to infer conclusions from basic samples, and to externally validate such conclusions. still, this was one of the very few studies with this type of external validation and more are needed for clinical application. big data can also be used to assist geriatricians for personalized medicine, defined as a medical approach in which treatment is customized on an individual basis based upon disease subtype, genetics, risk, prognosis, or treatment response using specialized diagnostic tests (frohlich et al., ) . for instance, predictive biomarkers for the early detection of certain diseases, may help both patients and doctors to decide on appropriate treatment pathways. in addition, the 'internet of things' refers to the ability of technology to send and receive data via the internet. as wearable/compact technologies become more prevalent (i.e., phone pedometers, pacemakers, insulin trackers) and their data becomes easier to store and share, so too does it become easier to use life-logging data to track individual's wellbeing. unfortunately, while there is great potential for this type of technical approach, there are currently very few cases of applications within clinical practice (frohlich et al., ) , with many studies still in an exploratory phase, requiring further research. for example, one study shows that machine learning techniques have significant potential in developing personalized decision support for chronic disease tele-monitoring systems; however, it was noted that the system would be improved with a larger library of comprehensive predictive markers (finkelstein and jeong, ) . the use of radiomics, the high-throughput mining of quantitative image features from standard-of-care medical imaging that enables data to be extracted and applied within clinical-decision support systems, has also been proposed, especially within the realm of dementia prevention and detection . these studies have benefited from large sample sizes (> , images) using machine learning. this brings us to the issue of noise reduction, which is crucial for effective use of big data and will enable a more robust extraction of features. given the immense amount of data expected to be handled in future projects, finding ways to store, process, and analyze this data also presents a challenge for future research. at the societal level biomarkers have numerous applications. monitoring population-level biomarkers will likely provide an accurate, real-time view of the health state of a given area. this will allow for targeted interventions catered to suit the specific needs of a population. as stated earlier in this piece, modern medicine has provided for major increases in both quality of life at old age, and life expectancy, however, this can also be considered a potential societal burden. earlier the use of federated systems with respect to online medical records and data sharing was discussed as a potential hurdle to some countries and medical systems in the world. china has recently embraced a centralized health informatics scheme, with over % of medical organizations above the county/district level, % of town level hospitals and all cdc above the county/district level capable of transmitting real-time reporting on the status of epidemics via the public health information system (zhang et al., ) . in the future, the data provided by a centralized medical record system has the capacity to train numerous machine learning algorithms for use with biomarkers. another challenge for population-level biomarker implementation is to select low-cost, minimally invasive testing that can be used at a large scale. with respect to china, great advances have been made in the use of medical informatics within the past years. however one of the hurdles going forward for the country is that much of this investment has been driven by industry and the private sector, and a major priority for the country's future should be to divert resources to academic research (liang et al., ) . this is especially true for the poorer members of society, or those without ready access to healthcare, as biomarker are an asset in devising appropriate healthcare plans for populations in need . addressing rural areas may be a challenge both in terms of healthcare delivery and biomarker testing, as these regions may lack sufficient infrastructure for both, posing a challenge for the future . we recommend the use of mobile-equipped information technology services to reach more remote regions. in summary, biomarkers have a great deal of potential for how doctors can prevent, diagnose, and treat illness associated with ageing. while there are many hurdles going forward, the application of machine learning and big data to biomarker research will provide new opportunities to understand ageing at the molecular level, deliver personalized treatment at the individual level, and design influential and effective policy at the societal and population level. since the beginning of the st century, china started to enter a period where it may be classified as an ageing society. at the same time, the compulsory healthcare insurance systems in china has undergone a comprehensive and rapid development, while still emphasizing the ideologies of health equity and social justice . three major health insurance schemes have been launched, achieving near-universal coverage in a short time, which gained early appraisal by emulating the goal of the provision of affordable and equitable basic healthcare for all by (yip et al., ) . after the establishment of the urban employee basic medical insurance (uebmi) in , the chinese government implemented the new rural cooperative medical scheme (ncms) for rural residents in , and the urban residents basic medical insurance (urbmi) for urban residents without employment in . as a result, social health insurance coverage increased from . to . % between and , and further to . % by , and has been stable since (meng et al., ) . in order to further reform the fragmented health insurance system, the latter two of these schemes were combined into the basic medical insurance for rural and urban residents in early , with a target of making the system less complicated, but more equitable for various social groups. in the past years of the new round of healthcare reform beginning in , the chinese government dramatically increased financial investment, with half of all investment in the form of funded premium subsidies for residents to be covered by the social health insurance system (yip et al., ) . universal coverage has since led to improved access to and utilization of healthcare (meng et al., ) , decreased the prevalence of catastrophic health expenditure (yip et al., ) , and reduced out-of-pocket expenditure as a proportion of total health expenditure, especially for vulnerable groups, including older adults (xu and mills, ) . however, the social health insurance system in china still faces the dual challenge of population ageing (demand) and inefficient delivery on the side of the healthcare system (supply), raising both health expenditures and individual disease burden. out-of-pocket expenditure as a proportion of disposable personal income increased from . % in urban regions and . % in rural areas in to . % in (xu and mills, ) . concretely speaking, population ageing addressed the increasing health and social care needs of older people. according to the report on the fifth national health services survey, the prevalence of non-communicable disease had increased more than % between - , from . to . %, while the inpatient rate rose from . to . % in between - . the outpatient rate also increased to . % in (nhfpc, ) . the reimbursement of social health insurance improved rapidly and accounted for % of total health expenditure in , though while out-of-pocket payments dropped from % in to % to , financial protection and services packages were insufficient for the elderly (meng et al., ) , especially for those in rural regions. reported a three times-higher risk of catastrophic health expenditure among the old population in rural regions . in , expenditures on hospitalization for older people in urban areas were reimbursed % by social health insurance and % were covered for their rural counterparts (who, b). regional disparity in health benefits for the elderly with insurance aside, a problem of inequity among different health insurance schemes on health outcomes for older adults is still a great challenge. uebmi recipients were found to have better physical and psychological health outcomes compared to those with urbmi or ncms insurance. this demonstrates a transformation in health insurance reform from an emphasis on the opportunity-oriented health equity measured by coverage and healthcare accessibility to stressing outcome-based equity composed of health outcomes for the elderly, namely "outcome-based health equity", giving priority to disadvantaged groups . in terms of supply-side deficiency and unsatisfied progress in the past years, gaps in the public hospital and pharmaceutical reform have tremendously limited the effectiveness of social health insurance reform, even though the public hospital has removed mark-ups for drug sales, adjusted pricing mechanism, reformed provider payment systems and changed governance structures at the county level (yip et al., ) . the hospital-centered health delivery system has induced the growth of both health expenditure and health insurance expenses, which worsened the control of non-communicable diseases and health outcome improvement in ageing society. unexpectedly, the usage of outpatient and inpatient services in primary health facilities declined from % and % in to % and % in . due to the lack of qualified long-term care facilities, the length of hospitalization was longer for the old population aged and over (who, b), demanding higher expenditure input to cope while wasting health resources. we advocate the immediate application of an integrated health and social care-oriented, particularly in community settings, with the objective of increasing affordability and improving the quality of care for older people. population ageing, family structure shift, and migration, were three major challenges limiting the efficacy of traditional informal care provided by families and their networks. a large proportion of older people with functional disability or dementia will continue to create enormous challenges for an immature long-term care system in china . it was estimated about million ( . % of the elderly) older people had some sort of functional disability by , among which . million ( . % of old population) had a serious status of disability (nhfpc, ) . at the same time, china has become the largest country in the world to have over . million people with dementia (jia et al., ) . in response to the increasing need for social care of older people with disability, the central government of china has implemented a pilot practice of ltci policies in cities, while some local governments were also encouraged by the central government to initiate county-level pilot experiments on ltci since , in hopes of stimulating the growth of long-term care providers (luo and zhan, ) . most ltci schemes were based on the social health insurance system, though these pilots had distinct and diverse eligibility conditions, premium contributions, need assessment instruments, and benefit packages. the reason for carrying out a pilot practice rather than fully implementing a uniform nation-wide scheme reflected the complexity of ltci, and a worry about cost escalation noted ltci introduction in the more mature ageing societies of japan and germany. after two years of practice, a few evaluations were conducted to estimate the outcome of these pilot practices, identifying a host of problems. there are several characteristics and unique features present in the chinese ltci scheme. at first, coverage was narrow and limited only to older people with the most serious degrees of disability, and excluded older adults with dementia due to security issues and lower quality of care skills. by the end of , less than % of the older population in the pilot cities were covered by ltci plans in qingdao (zhu and osterle, ) , which was the first city to launch the ltci scheme in china, a higher proportion of those years and older was achieved in the ltci practice of the mature ageing populations in germany ( . %) and japan ( . %) (oecd, ) . secondly, the need assessment tools used by each pilot city were fragmented and biased. some pilot cities or counties only employed the barthel index to measure physically functional disability, but did not measure cognitive function with any scales, thus leading to the exclusion of older people with dementia from ltci coverage. more seriously, the results of need assessment were not applied to long-term care service provision, but only used as a "gate keeper" for receiving the fixed benefit package. assessment tools should be transformed from simple to comprehensive, from a physically oriented test to a multi-dimension health status one, even from health assessment to service assessment. thirdly, in most pilot plans, long-term care was provided by designated institutions through a contract, and a homeand-community-based caregiver was paid by the insurance scheme, however reimbursements were limited such that a large proportion of costs was still paid out-of-pocket by service users themselves, and unmet needs were still high among the disabled elderly . in addition, the inequality in access to long-term care services between advantaged and vulnerable elderly was enlarged. in most pilot schemes, higher numbers of benefit packages were allocated to insured groups living in nursing homes or receiving formal care than to those living at home receiving informal care. retired people with uebmi had higher affordability and preferred to live in the institutions and received higher reimbursements from insurance. rural residents could not access good quality long-term care facilities, and received fewer benefits. the inequality that remains in ltci practices highlights how policy reform ought to reevaluate and reconstruct the currently fragmented schemes and direct more attention to the disabled elderly with lower socio-economic status and without financial or family support. although china attempted the ltci scheme, its most urgent priority was to establish a unified meanstest public budget system to cover the most vulnerable social groups regardless of their living locations. through lu et al. ( ) 's projection, an investment as small as . % of gdp (equivalent to about . % of fiscal revenue) would greatly benefit the frail elderly and those with serious problems of functional disability and/or poor financial status . in , the central committee of the communist party of china and the state council issued the healthy china plan. corresponding with the health-related sustainable development goal (sdg), this is a national mid-term and long-term strategic plan for moving towards universal health coverage and improving health equity, with emphases on health coverage for the whole life circle, including healthy ageing (prc, ). in , china made a major restructuring of national healthcare governance. the national health commission (originally called the ministry of health) administers and regulates the healthcare delivery system and include two new areas of responsibility: elderly care and tobacco control (yip et al., ) . in addition, the national healthcare security administration was established. it is in charge of administering essential health insurances (urban employee basic health insurance, urban-rural resident basic health insurance, which integrated the original urban resident basic health insurance and new cooperative medical scheme) and medical assistance for the poor and vulnerable groups as well as deciding on pricing and drug procurement. rapid ageing and an alarming increase in non-communicable diseases (ncds) have arisen as major health concerns in china marten et al., ) . in , the national basic public health service program was established, which included health management for elderly people, patients with major ncds (hypertension and diabetes), among others (nhfpc, ) . the program is financed by government funds, and the government's per capita allocation increased from to rmb between (nhfpc, . china's ongoing healthcare system reform prioritizes transforming hospital-centered treatment care to integrated and continued care through a tiered healthcare delivery system (meng et al., ) . a tiered healthcare delivery model defines the functions at each health facility level, and coordinates care across levels. a common model is that hospitals lead medical alliances to deliver integrated care, and provide support and training to strengthen primary health services wang et al., b; wbwho, ) . in addition, residents are able to register with a family doctor team who provide preventive and basic healthcare as well as referral services. the government target is universal registration by (nhc, ) . china has made good progress in improving equal access to healthcare and financial risk protection for socially vulnerable people over the past decade (fu et al., ; meng et al., ; yip et al., ) , but challenges remain. there is a lack of qualified primary healthcare providers who are able to serve as gatekeepers, and the quality of primary healthcare is poorly characterized meng et al., ) . previous studies reported very low proportions of blood pressure and blood glucose control among patients with hypertension and diabetes seeking care from primary health facilities, and common over-prescription of antibiotics su et al., ; wang et al., ) . patients persistently bypass primary health facilities and seek perceived good quality of care in high level hospitals, despite many patients complaining of high medical costs and long wait times . on the other hand, most hospitals still largely rely on fee-for-service payment and tie doctors' salary to the hospital revenue generation, which gives hospitals an incentive to attract and retain patients rather than shifting them primary healthcare. overuse and overprovision of health services are common in china (meng et al., ; yip et al., ) . consequently, health expenditure has continued to escalate, a trend which threatens the long-term financial sustainability of basic health insurance schemes. the efficiency in using health resources is low (meng et al., ; yip et al., ) . as china continues to progress as an ageing society, strengthening primary healthcare system to provide integrated care will be fundamental to meet growing health needs and obtain the best value from existent health resources. it is difficult to shift from treatment-based intensive care to population-based preventive care and health management while perverse financial incentive for hospitals are not controlled or eliminated. this requires effective collaboration across related sectors led by a strong coordinating authority and needs to bridge policy dialogue to ensure health in all policies workable and achievable. china's prolonged demographic shift has led to decreased fertility, elevated sex ratios, rapid ageing, fast urbanization and major geographic redistributions (peng, ) , an interdisciplinary collaborative approach is necessary to prepare and face the challenges as society continues to age. we present a summary on ways to achieve a healthy ageing society in china at societal, individual, and molecular levels (fig. ) . breaking knowledge gaps and eliminating boundaries among different sectors to further integrate and synergize different healthcarerelated parties at societal, individual, and molecular levels will optimize the outputs of the chinese healthcare system. the chinese government has adopted a positive stance to investment across the whole spectrum of ageing policies, medical education and training, basic ageing and geriatric research, prevention, primary care, and hospital and residential care. it is necessary to establish updated ageing policies on retirement age, to incentivize employment of the elderly, to encourage lifelong learning, and to invest in senior volunteer programmes (yeoh and lai, ) . the education and practice of geriatric medicine has been and will continue to be enhanced, including to further increase the teaching of geriatrics-related subjects in medical school, to design high-quality residency and fellowship programs, and to further integrate geriatric principles into general clinical practice (yu et al., a) . the establishment of the national alliance of ncrcgd has been highly appreciated and welcomed and it will continue to serve as a national platform to educate and train geriatricians. while the achievement of healthy ageing and longevity is emerging as an important task for china as in many other countries, this may also be accompanied by socio-economic challenges. one of the major concern is that creating a society where healthy and active ageing and longevity are taken for granted may lead to a swelling of the elderly in the workforce, leading to limitations in job availability for the young, and proving to be a potent economic issue. countries like china and south korea are entering a society of population ageing, showing low birth rates and increased life expectancy, which changes the whole economy korea, ) . population ageing will likely have several macro-economic effects, touching various domains such as overall industrial structure, current account and inflation, output growth, household finance, labor markets, consumption, and even fiscal and monetary policy (korea, ) . it is therefore imperative to give a comprehensive assessment of population ageing in view of its effects on society and the economy in the long-term, to provide evidence to inform future policies. while a challenging task, some suggested responses to the early-emerging changes that could be taken to offset the effects of the ageing society include promoting the production of larger families in the young, finding ways to ensure jobs remain for the young should the elderly be able to continue longer in their positions, along with more general preparations on transform to an elderly-friendly society. it is delightful to witness the progress of basic and translational ageing research in china, as supported by increases in the number of grants and funding opportunities, as well as by rising numbers of high profile publications and discoveries (he et al., c) . joint efforts from the government and stakeholders of each and every sector should be encouraged to nurture an elderly-friendly society, of most import are reforming the social support system to support china's ageing society, and the introduction of health service/investment interventions aimed at reducing inequalities in health among older people in china. we suggest current research focus on basic and translational gerontology to improve healthy longevity in the elderly, and on developing an integrated and affordable health and social care delivery system to meet the complex needs of a growing elderly population, and to finally transform china into an ageenabling country where well-being and healthy longevity can be celebrated for decades to come. in response to the ageing society and in order to improve the quality of life of the elderly in china, strategies at societal, individual, and cellular levels are presented, detailed in 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(per people) of viral hepatitis, pulmonary tuberculosis (p.tb), influenza, hiv infection and aids from to were extracted and presented as general (open) or aged ( years or older, closed) population ), the th population census of china ( ) and projection ( - ) of china's national bureau of statistics. c. women account for % of the total number of centenarians in china and the proportion of rural centenarians is far higher than that of urban area. data source: china's population census, excluding hong kong, macau and taiwan area. the map was made by r. d. geographical distribution of the relative number of centenarians. the proportion of centenarians in china's total population (centenarian ratio) has a significant regional imbalance the authors acknowledge the valuable work of the many investigators whose published articles they were unable to cite owing to space limitations. the authors thank dr. vilhelm bohr at the nia and university of copenhagen for reading of the manuscript. e.f. key: cord- - ujw mn authors: price, alex; schwartz, robert; cohen, joanna; manson, heather; scott, fran title: assessing continuous quality improvement in public health: adapting lessons from healthcare date: - - journal: healthc policy doi: nan sha: doc_id: cord_uid: ujw mn context: evidence of the effect of continuous quality improvement (cqi) in public health and valid tools to judge that such effects are not fully formed. objective: the objective was to adapt and apply shortell et al.'s ( ) four dimensions of cqi in an examination of a public health accountability and performance management initiative in ontario, canada. methods: in total, semi-structured, in-depth interviews were conducted with informants from public health units and the ministry of health and long-term care. a web survey of public health managers in the province was also carried out. results: a mix of facilitators and barriers was identified. leadership and organizational cultures, conducive to cqi success were evident. however, limitations in performance measurement and managerial discretion were key barriers. conclusion: the four dimensions of cqi provided insight into both facilitators and barriers of cqi adoption in public health. future research should compare the outcomes of public health cqi initiatives to the framework's stated facilitators and barriers. this study examines the implementation of a public health accountability and performance management system featuring declared principles of continuous quality improvement (cqi) in ontario, canada. cqi is an approach to the management and improvement of organizational services and processes (dilley et al. ; nicolucci et al. ; radawski ) . the approach stands in contrast to quality control and assurance by virtue of its focus on identifying opportunities to improve work processes as opposed to identifying individualized problems and maintaining a status quo (dever ) . cqi relies heavily on performance measurement and analysis, as well as on the involvement of leadership and front-line staff in decision-making processes (kosseff ; mclaughlin ; radawski ) . the adoption of quality improvement approaches such as cqi in public health has been a recent and popular development (capacity review committee ; corso et al. ; dilley et al. ) . despite this phenomenon, there exists a limited body of empirical evidence on the impact of quality improvement approaches in public health settings (corso et al. ; dilley et al. ; mclees et al. ; riley et al. ) . moreover, valid and reliable frameworks for assessing the integrity and impact of such systems in public health are still emerging. in contrast, development of cqi in healthcare settings has been much more extensive, dating back to the late s (chinnaiyan et al. ; radawski ; rex et al. ) . this study uses shortell et al.' s ( ) four dimensions of cqi as an analytical framework for assessing a public health quality improvement initiative in ontario ( figure ). the four dimensions of cqi represent an assessment framework derived from systematic reviews of empirical healthcare research. in addition, shortell et al.' s earlier research on the cultures of high-performing organizations is used to augment the cultural dimension of the adapted framework (shortell et al. ) . for instance, developmental cultures featuring an emphasis on risk-taking, innovation and change, as well as group cultures with strong teamwork and participation, found the greatest success in supporting cqi initiatives. hierarchical and rational cultures that stress bureaucratic norms and narrow definitions of achievement were found to act as barriers. within clinical health research fields, the four dimensions of cqi have received empirical validation (bennett and crane ; forsner et al. ; solomons and spross ) . one example includes forsner et al.' s ( ) controlled study of evidence-based practice in swedish psychiatric care. the investigators examined the implementation of clinical guidelines and found that in the test group, in which the four dimensions of cqi were applied, the reported guideline compliance was significantly greater (p < . ) than in the control group. many of the key factors presented in the four-dimensions framework overlap with those emphasized in the public health quality improvement literature. for instance, in their qualitative study of quality improvement initiatives in various public health departments in the us, riley et al. emphasized leadership and appropriate performance measures, which are also highlighted in the strategic and technical dimensions of cqi (riley et al. ) . resource inadequacy was a key barrier in mclees et al.' s ( ) study of public health agencies involved with the national public health improvement initiative in the us, as it is in the strategic dimension of shortell et al.' s framework. the importance of training and education in quality-improvement concepts and techniques is also stressed in both the public health literature and the technical dimension (corso et al. ) . knowledge transfer and exchange, supportive organizational cultures and the influence of implementers in decision-making outlined in the structural, cultural and strategic dimensions were factors that did not appear to have extensive profiles in the public health literature. the public health system in ontario features several key stakeholders, including the ministry of health and long-term care (mohltc), boards of health and local public health units. the ministry provides provincial stewardship and % of core funding for the public health system and is also charged with upholding key legislation. boards of health are municipal and regional public health governing bodies that are responsible for overseeing their corresponding public health units and providing them with the remaining portion of core funding. public health units are the agencies that deliver programs and services in their respective jurisdictions. following the outbreak of severe acute respiratory syndrome (sars) in ontario, a major reform of the system was initiated by the minister of health (smitherman ) . this reform included the declarative adoption of cqi as a means of pursuing performance improvement (capacity review committee ; law et al. ; mohltc mohltc , . cqi adoption has taken the form of a system of accountability and performance management, currently undergoing implementation across municipal and regional public health jurisdictions. the system is composed of ( ) the ontario public health standards (ophs), conditions and processes that offer the greatest opportunity for improvement training and information systems needed for quality-improvement efforts mechanisms for facilitating learning through the organization and system which outline the program and service requirements for boards of health and public health units, as well as broad goals and outcomes across each area of public health; ( ) accountability agreements between the ministry and boards of health and their public health units that establish specific performance indicators and targets related to areas of the ophs; ( ) organizational standards that articulate management and governance requirements for boards of health and public health units; and ( ) reporting requirements for the collection and analysis of performance measurement information (mohltc (mohltc , (mohltc , . a mixed-methods approach consisting of key informant interviews and a web survey was used to assess ontario' s public health accountability and performance management initiative. all data collection and analysis were conducted by the principal author with university ethics approval and editorial feedback from co-authors. this study used many elements of a case study approach, such as interview and survey methods and triangulating analysis, which have been used extensively in the field of implementation research (long and franklin ; mcdermott ; mischen ) . research conforming to case study characteristics has also been used to investigate public accountability and performance management (christensen and laegreid ; hildebrand and mcdavid ) . key informant interviews were conducted in three public health units (sites a, b and c). sample selection was conducted to reflect diverse implementation contexts characterized by both rural and urban service environments, as well as municipal and regional governance. in total, semi-structured key informant interviews of ~ hour in length were conducted. all interviews were tape-recorded and professionally transcribed in full. public health unit informants included executive, management and specialists in various areas of public health, such as chronic and infectious disease prevention and control. these groups of individuals represent the primary implementers of the province' s public health accountability and performance management intervention. four separate interviews with representatives of the mohltc were also conducted during the same period of data collection. these interviews also followed a semi-structured approach and included individuals directly involved with the development of the province' s quality improvement initiative. interview questions for both public health unit and ministry informants included specific and broad items relating to facilitators and barriers within the four dimensions of cqi. for example, ministry and public health informants were asked to choose characteristics of shortell et al.' s ( ) organizational cultures typology (i.e., teamwork, risk-taking, bureaucratic, efficiency-focused) that best reflected their work environment. broader items included questions asking informants to independently identify what conditions or factors were critical to the success of implementing ontario' s system of accountability and performance management. in addition to key informant interviews, a web survey of public health managers was conducted. targeting all public health managers in each of the province' s health units, recruitment involved contacting each senior executive to seek approval and access to their organizations. in total, public health units agreed to participate and provided contact lists of public health managers; surveys were distributed; questionnaires were returned, providing a response rate of . %. this sample, while only covering one-third of all public health units, represented a near-equivalent distribution of rural, mixed rural and urban, and urban jurisdictions. survey questions, for example, asked about manager discretion, relating to stakeholder decision-making in the strategic dimension; resistance to the intervention, relating to barriers in the cultural dimension; familiarity with components of the initiative, as well as sentiment regarding performance measurement pertinent to the technical dimension; and prospective thoughts on the use (and usefulness) of collected information for performance management and quality improvement. directed content analysis was applied to qualitative data by using an initial coding frame informed by pre-existing empirical and theoretical literature (hickey and kipping ; hsieh and shannon ; potter and levine-donnerstein ) . strong, anomalous themes were then coded separately. established codes were then matched with facilitators and barriers of shortell et al.' s ( ) four dimensions of cqi and analyzed. quantitative data collected using keysurvey.com were recoded for descriptive and bivariate analyses using spss. two-sided fisher' s exact tests (p ≤ . ) assessed association because of the small survey sample (daya ) . findings from the survey supplement the qualitative data, and all presented findings did not feature missing data (n = ). the findings in this study are presented across strategic, cultural, technical and structural dimensions and focus primarily on the facilitators and barriers in the four-dimensions framework. overall, evidence of both facilitators and barriers in each dimensional category related to ontario' s system of public health accountability and performance management was apparent. the strategic dimension emphasizes the importance of leadership, communication and inclusion of all stakeholders in decision-making. analysis of interview data found statements of strong leadership expressed by each public health unit. local-level leadership in quality improvement focused mainly on outcomes in priority populations, such as immigrants from countries with endemic infectious diseases. ministry informants identified leadership as a key driver of implementation efforts and acknowledged its strength within public health units, who they felt shared their interest in showing high performance. a site-b informant confirmed this leadership sentiment: "well, we have very strong leadership values of teamwork and participation and participatory management in most of our program areas. i think we are very strong that way." -site-b informant communication relating to the initiative was evident from interview findings identifying various forums for the development and conveyance of its elements. several public health unit informants noted that the province' s new system of accountability and performance management had prompted both internal and external dialogue, which has since increased their understanding of performance objectives and quality improvement more broadly. site-a stood out as a particularly strong example of this: "i think that changing conversations has actually motivated people, not just here in the health unit but even as i talk to people across the province. people like the fact that we are being asked to think about these questions and like the fact that we are going to be held more accountable for actually making a difference." similarly, a large proportion of survey respondents reported moderate or great familiarity with many components of the intervention, including accountability agreements ( %), performance targets ( %) and reporting requirements ( %). implementer inclusion in decision-making was mixed. although many public health unit informants cited participation in committees and working groups related to the cqi initiative, their influence over final decisions varied. in some cases, such as human papillomavirus (hpv) vaccination, public health agents were able to negotiate "more realistic" performance targets. in other instances, local informants noted that the ministry took a hard line in making decisions despite concerns voiced by the field. for example, when a prescriptive ophs protocol for tuberculosis follow-up was challenged because of evidence of alternative best-practice, requests to change the protocol were denied by provincial decision-makers. one ministry informant corroborated this dynamic by stating their interest in the input provided by the field, but the decisions ultimately rested with those holding authority over legislation: so, yes, [consultation] is to enable conversations within a forum that in a sense the majority of the practitioners and the province have agreed to talk about. it' s supposedly a partnership. the province always has the upper hand. (laughing) he who controls legislation has the upper hand." -ministry informant informants in each of the three public health unit interview sites raised concerns over the narrow timelines for achieving targets. one ministry informant noted that many of the targets are set to %, matching with the ophs, and that even public health units with low baselines would be expected to meet targets within the first two years of implementation. divergence between the ministry and the field was expressed in terms of provincial and local health priorities. some informants argued that targets set by the ministry such as senior falls were not a priority in their jurisdiction or, generally, a major responsibility of public health because of small target populations and the many determinants outside of their control. although many public health unit informants acquiesced to the province' s quality improvement initiative, each of the local public health unit interview sites placed greater emphasis on internal systems of performance management to foster meaningful performance improvement. for instance, one site-a informant stated: "at this point i feel more confident in our organization' s capacity to demonstrate success in performance management than i do with the two indicators my team has been given within the accountability agreement system from the ministry of health and long-term care." -site-a informant despite the implied and explicitly stated opportunity cost created by misalignment in local and provincial priorities apparent in interview findings, % of survey respondents disagreed or strongly disagreed that an emphasis on provincial performance measurement and target achievement would interfere with the quality of program and service provision at a local public health level. resource inadequacy was often referenced in relation to the cost neutrality of the intervention and the current public health funding model, more broadly. while public health unit informants highlighted the quality of their agencies' human resources, some did not consider general resourcing to be adequate for achieving all targets -a phenomenon that was reflected by nearly one-third of surveyed public health managers. issues of increased burden on public health units to show compliance with provincial targets and fulfill local priorities were, in some cases, compounded by rapidly expanding local populations that the current public health funding model does not compensate for. for example, one site-b informant explained: "i think that both financial and human resources, i think for most if not all boards of health [our] reach is beyond our grasp … [our] population increases five to ten thousand a year. basically i' ve been getting base budget increases for the last few years. in other words very few if any new staff to service a population even over the last four years that would be in the order of twenty to forty thousand additional people." -site-b informant ministry informants acknowledged the need for greater equity in the public health funding model, although some were not convinced that public health performance improvement required additional funding, but rather greater efficiency. other barriers such as work overload did not have a strong profile in the data, although some public health unit and ministry informants speculated that smaller, rural health units may struggle with performance expectations related to intensive analytical tasks such as population health assessment. facilitators of the cultural dimension are distinguished by openness, collaboration, teamwork and learning. at the local level, all three public health unit interview sites exhibited at least assessing continuous quality improvement in public health: adapting lessons from healthcare some of the characteristics of developmental and/or group culture. site-a exhibited many characteristics of group culture, such as teamwork and participation. organizational hierarchy appeared fairly flat, and even front-line workers were said to be involved in program decisionmaking, collective priority-setting and performance monitoring. one site-a informant noted: "certainly i think we prided ourselves on teamwork and participatory management styles and participation of front-line staff into decision-making where that makes sense." -site-a informant site-b appeared to be an equally distributed mix of developmental, group and rational cultural types -emphasizing efficiency and achievement of ophs requirements. group culture was apparent in reference to the interdisciplinary team-based approach to program and service provision. leaders also regarded teamwork as an important value of their culture, as illustrated by instances of participative management in various program areas. developmental culture emerged in the context of the health unit' s internal, evidence-based approach to cqi planning, which allowed for informed innovation and risk-taking. a site-b informant expanded by stating: "… there has been a very strong undercurrent in my organization … that your programming is evidence-based and you have a method for reviewing it and each time trying to learn more about how it went and improve it. it' s a continuous cycle of implementation, reflection, evaluation, and review and kind of revision. so there is constant introduction of innovation as well as fine-tuning things as they go." -site-b informant site-c presented a dominant developmental culture. risk-taking and innovation were often regarded as very important aspects of the organization' s culture. these aspects of developmental culture were contextualized in terms of evidence-informed decision-making, which was paradoxically argued to reduce risk at the same time. risk-taking in the development of strategic plans and priorities and examples of innovative programming were highlighted as proof of the health unit' s commitment to a developmental culture. an example of one site-c informant reflecting on the health unit' s organizational culture explained that: "… evidence informed decision-making is a large component. it' s one of the strategic priorities in our health unit and so really having that … engaging in processes of informed innovation certainly informs decision-making and out of that what are the risks that we are taking to do things differently than other health units based on the evidence that we have found." -site-c informant resistance to change, unrewarded achievement, and hierarchical and rational organizational cultures are regard as barriers to the cultural dimension. in this regard, there was limited evidence of an approach for rewarding achievement and good performance related directly to the province' s cqi initiative. however, some public health unit interviewees argued that celebrating achievement of targets was important -something that their health units did internally when goals were achieved or improved upon. site-a provided an example of this: "i think setting targets and celebrating the reaching of the targets is the other part. part of our plan will be not just setting goals but also celebrating the achievement of the goals … what we look at when we set out goals for staff and within the organization, knowing that we are not going to achieve every goal every time but celebrate our achievements and keep us moving forward." -site-a informant moreover, there was some uncertainty about the level of support for facilitating factors and the presence of barriers such as hierarchical cultural norms. on the issue of whether the system was primarily intended to promote learning (a key characteristic of cqi), those surveyed in the area of chronic disease prevention were significantly more uncertain than respondents from other areas (p < . ). likewise, . % of the survey sample agreed or strongly agreed that the initiative was primarily concerned with maintaining compliance with public health practice and performance expectations -resembling a quality assurance orientation. in addition, respondents in the area of emergency preparedness were more likely to disagree (p < . ) with the statement that data generated from the provincial initiative would be used to improve performance. training opportunities and the quality and availability of data are the primary facilitators in the technical dimension. in ontario, training in quality improvement, and cqi specifically, manifested mainly at the local level, with public health units providing instruction to staff on strategic planning. guidance in program and service provision was evident through provincial ophs protocols, but these materials did not relate specifically to quality improvement training. a site-a informant reflected on this gap: "i' m not aware of any kind of … the how stuff that' s come from the ministry other than just … okay your targets are now being established with an expectation we do something about them." -site-a informant gaps in training and data systems can be precursors to frustration and false starts, according to shortell et al. ( ) . guidance from the ministry on how public health units were to achieve performance targets or improve was limited. moreover, some guidance materials, such as the previously mentioned tuberculosis protocol, were criticized by site-c informants for not reflecting best available evidence and local expertise: "so we had examples where we are absolutely convinced that we should vary the standards or not conform exactly with the [tuberculosis] protocol. this is the ministry telling us how to practise public health where actually we know more about practising public health than they do … it always ends up the same way because their lawyers advise them to stick to the letter of the law. i don' t know. something to do with liability. this is not the best use of our resources." -site-c informant considerable concern with the quality of performance measurement information relating to the provincial initiative was raised by all parties. the choice of population health outcomes as measures of public health performance was identified as problematic because of externalities that made attributing public health outputs difficult. some performance indicators were perceived as unreflective of public health performance by health units. for instance, the tobacco use indicator was highlighted as one such problematic measure: "we only have one performance indicator that relates to chronic disease and that is the one about the number of youth who smoked a whole cigarette. i think it doesn't reflect in any way the work that we do but i understand the ministry' s need to show a tangible objective outcome and so we will do that and be happy with providing that information. i would say it has very minimal contribution to anyone understanding anything about what we do." -site-b informant ministry informants generally agreed that information systems needed to be improved and that this task was a difficult one. however, ministry informants also noted that where evidence was weak, best-practice information was used in place of causal linkages between ophs requirements and outcomes. one ministry informant explained: "so the real work is at the linkages between requirement, to short-term outcome, to medium-term, to long-term outcome … so wherever we made a link we found evidence to support that but where we couldn't, it was based on best practices and what was occurring in the field and the assumptions that were being made that had been integrated right at the beginning of the ' standards all the way through." -ministry informant the structural dimension focuses on effective forums of communication for facilitating learning throughout an organization or system. in ontario, the cqi initiative is supported by several communication forums, such as accountability agreement working groups, committees and monthly teleconferences amongst public health specialists, leadership and the ministry. at a local level, several public health unit informants noted active lines of communication between themselves and other public health units pertaining to collaborative projects, research and other forms of knowledge production and exchange. in contrast, some ministry informants stated that public health units do not typically work cooperatively or collaboratively because of jurisdictional protectionism. this divergence in perspectives was reflected in informants' testimony: "the fact that none of them work cooperatively, the fact that there are turf wars and all that good stuff, i think is one of the challenges." -ministry informant "i think there is a lot of similarities between health units. we talked a lot." -site-b informant "we work really well with our partners so we can capitalize on limited resources and make the most of them so that again we can really accomplish the goals we set out for communities and make our communities healthier places to be. so we do a lot of collaborative work with other health units but also with our community partners as well in order to accomplish public health goals." -site-a informant within the structural dimension, the lack or limited use of communication mechanisms related to the quality improvement initiative fosters an inability to produce knowledge and diffuse it within systems. ambiguity relating to how information would be fed back to public health units and used for quality improvement was apparent and highlighted by local informants: "i don't know. i think that remains to be seen. i' m hoping it' s more to be used in a combination with evidence to make ongoing improvements to public health programs and policies." -site-c informant ministry informants stated that performance information would allow for "discussion" with public health units. some public health unit informants speculated that these discussions would include questions of what barriers to performance existed. one public health unit interviewee noted that performance information lacked the context to address why the results were the way they were. meanwhile, several other informants argued that their public health unit would have to provide additional, unsolicited information to explain their performance achievement. one site-b informant explained: "so, in my earlier interview with you i described some of the vehicles that you can use and that i voluntarily send to the ministry like our performance report, it' s rare that i would get an acknowledgement, let alone do they read it. so i don't think the ministry is all that interested in what we are doing apart from the information that we use to populate what i would call to be our financial reports." -site-b informant in contrast to the provincial initiative, all public health unit interview sites described specific internal processes of quality improvement such as balanced scorecards, evaluation, assessing continuous quality improvement in public health: adapting lessons from healthcare reporting and strategic planning elements. only % of survey respondents believed the province' s system of accountability and performance management had the intent of providing learning opportunities and improving performance. this study shows a mix of facilitators and barriers to cqi best-practice in ontario, according to shortell et al.' s ( ) four-dimensions framework. evidence of strong leadership interest and involvement in quality improvement at both local and provincial levels was clear. strong developmental and/or group cultures were also evident at public health unit interview sites, which reflected leadership efforts to foster high performance and provided additional insight into their cqi capacity. the importance of senior and managerial leadership engagement cannot be over-emphasized, as previous reviews of public health quality improvement initiatives have shown (dilley et al. ; randolph et al. ) . however, ontario' s quality improvement initiative also featured limitations placed on the meaningful influence of local leadership in decision-making by provincial stakeholders, which was reflected by misalignments in priorities, even though agreement on the principle of quality improvement was mutual. a part of this phenomenon may be because of the split emphasis that ontario' s system of accountability and performance management has between quality assurance and quality improvement. assurance of legislative and service requirements promotes top-down decision-making and control, whereas a focus on improving outcomes requires local leadership and discretion. similar misalignments were highlighted in the work of degroff et al. ( ) who argued that many of the challenges to applying performance measurement to national public health programs in the us were due, in part, to the competing interests of quality improvement and public accountability (degroff et al. ) . in addition, the availability of indicators that accurately reflect performance continues to be one of the greatest constraining factors to cqi in public health settings, as many have already pointed out, and one that sets it apart from healthcare (kahan and goodstadt ; scutchfield et al. ; weir et al. ). public health unit informants were adamant that performance targets indicated by population health outcomes, which are subject to numerous determinants outside of their control, were problematic. given that cqi relies upon the quality of performance measurement information for informed decision-making, developing public health metrics that are more attributable to service outputs should be a priority. this study is limited by its small public health unit sample, which, although offers valuable insight into a nascent quality improvement process, ultimately, cannot represent the broader set of units. also, while boards of health are acknowledged to be important stakeholders in ontario' s public health system, members were not included in this study because of unsuccessful recruitment. furthermore, this study offers a snapshot of an initiative in a fluid environment and in its very early stages. changes to the approach are expected, which have potential implications on the perceptions of informants. this also means that evidence of outcomes resulting from the presence of facilitators and barriers was beyond the scope of this study. this study illustrates the applicability of shortell et al.' s ( ) four dimensions of cqi as a framework for understanding public health quality improvement. the study also represents one of the first attempts to examine the implementation of a cqi initiative across a complex public health system using an empirically derived and validated framework from the healthcare field. insight provided by the framework relating to facilitators and barriers of cqi implementation has largely confirmed disparate public health research on the topic (corso et al. ; mclees et al. ; riley et al. ; shortell et al. ). this confirmation is a promising indicator that the framework may hold value as a tool for public health decision-makers developing and implementing cqi systems. finally, future research should test the four-dimensions framework in other public health environments and, more importantly, examine the linkages between the framework' s indicated outcomes and attributable facilitators and barriers. hpv vaccination in ontario is voluntary. target levels had previously been set at levels comparable to those of mandatory vaccinations, such as measles, mumps and rubella (mmr) correspondence may be directed to: alex price; e-mail: alex.price@mail.utoronto.ca quality improvement efforts in oncology: are we ready to begin? revitalizing ontario's public health capacity: the final report of the capacity review committee impact of a continuous quality improvement initiative on appropriate use of coronary computed tomography angiography. results from a multicenter, statewide registry, the advanced cardiovascular imaging consortium performance and accountability-a theoretical discussion and an empirical assessment the national public health performance standards: driving quality improvement in public health systems fisher exact test challenges and strategies in applying performance measurement to federal public health programs improving outcomes in public health practice: strategy and methods quality improvement interventions in public health systems: a systematic review an approach to measure compliance to clinical guidelines in psychiatric care issues in research: a multi-stage approach to the coding of data from open-ended questions joining public accountability and performance management: a case study of lethbridge, alberta three approaches to qualitative content analysis continuous quality improvement and health promotion: can cqi lead to better outcomes? continous quality improvement a primer on quality in public health: what's needed to advance cqi in ontario public health the paradox of implementing the government performance and results act: top-down direction for bottom-up implementation incentives, capacity, and implementation: evidence from massachusetts education reform learning from experience: lessons from policy implementation advances in public health accreditation readiness and quality improvement: evaluation findings from the national public health improvement initiative ministry of health and long-term care (mohltc) ministry of health and long-term care (mohltc) ministry of health and long-term care (mohltc). . accountability agreements background for wdg board of health intraorganizational implementation research: theory and method four-year impact of a continuous quality improvement effort implemented by a network of diabetes outpatient clinics: the amd-annals initiative rethinking validity and reliability in content analysis continuous quality improvement: origins, concepts, problems, and applications lessons learned from building a culture and infrastructure for continuous quality improvement at cabarrus health alliance quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the u.s. multi-society task force on colorectal cancer developing a taxonomy for the science of improvement in public health public health performance assessing the impact of continuous quality improvement on clinical practice: what it will take to accelerate progress assessing the impact of continuous quality improvement total quality management concept versus implementation operation health protection: an action plan to prevent threats to our health and to promote a healthy ontario evidence-based practice barriers and facilitators from a continuous quality improvement perspective: an integrative review applying the balanced scorecard to local public health performance measurement: deliberations and decisions assessing continuous quality improvement in public health: adapting lessons from healthcare let's talk key: cord- -yqmi cqy authors: maxwell, cynthia; mcgeer, alison; young tai, kin fan; sermer, mathew; farine, dan; basso, melanie; delisle, marie-france; hudon, lynda; menticoglou, savas; mundle, william; ouellet, annie; yudin, mark h.; boucher, marc; castillo, eliana; cormier, beatrice; gruslin, andrée; money, deborah m.; murphy, kellie; paquet, caroline; steenbeek, audrey; van eyk, nancy; van schalkwyk, julie; wong, thomas title: management guidelines for obstetric patients and neonates born to mothers with suspected or probable severe acute respiratory syndrome (sars) no. , april date: - - journal: international journal of gynecology & obstetrics doi: . /j.ijgo. . . sha: doc_id: cord_uid: yqmi cqy abstract objective this document summarizes the limited experience of sars in pregnancy and suggests guidelines for management. outcomes cases reported from asia suggest that maternal and fetal outcomes are worsened by sars during pregnancy. evidence medline was searched for relevant articles published in english from to . case reports were reviewed and expert opinion sought. values recommendations were made according to the guidelines developed by the canadian task force on preventive health care. severe acute respiratory syndrome, or sars, emerged as a highly contagious and life-threatening condition in . by the end of , a total of cases had been identified internationally, and deaths were reported [ ] . although the majority of cases occurred in south east asia, probable cases, suspected cases, and deaths were reported in canada as of september [ ] . it is now known that sars is caused by a novel coronavirus [ ] [ ] [ ] and is easily spread by respiratory droplets and nosocomial contact [ , ] . evidence suggests that health care facilities are the major source for new sars infections; this was a major factor in the socalled "second wave" of sars infections in april and may in the greater toronto area. during this period, affected patients from outlying areas were transferred to a designated tertiary care hospital for treatment in order to limit the number of institutions with active sars cases. fortunately, only one case of sars occurring in pregnancy was reported in canada [ ] . this document summarizes the limited information available regarding sars in pregnancy and suggests strategies for managing pregnant women and their families in the antenatal, labour and delivery, and postnatal settings. the approach and recommendation of this document may be helpful in creating protocols for other new airborne viral infections. in february , the first cases of sars in canada, presenting as an atypical pneumonia, occurred in the toronto area. all cases that subsequently occurred in the region can be traced to one of the individuals first affected [ ] . similar outbreaks were reported in hong kong [ ] , vietnam [ ] , singapore [ ] , thailand [ ] , and taiwan [ ] . the diagnosis of sars was based on viral testing in combination with several clinical findings [ , ] . health canada has outlined the following basic principles for management and treatment of sars in non-pregnant individuals, as well as recommended testing for sars [ ] . in a study of patients with sars from the greater toronto area, most patients were exposed in the hospital setting ( %) [ ] . these individuals included health care workers, patients, and visitors to the hospital. the median time from self-reported exposure to onset of symptoms was to days. almost all patients received empirical antibiotic therapy ( %) and ribavirin ( %). forty percent of patients received steroids. of the % of patients admitted to the intensive care unit (icu), % required mechanical ventilation. there were deaths, or a . % mortality rate. predictors of poor outcome (death or admission to the icu) included increased age, male sex, diabetes, increased neutrophil count, creatine kinase, and urea. in a separate study assessing the outcomes of critically ill patients with sars in the toronto area, investigators found that % required mechanical ventilation [ ] . among those requiring ventilation, the mortality rate was %. in this study, transmission of sars within of the intensive care units that were evaluated prompted closure of medical-surgical icu beds, leading to health care workers being placed in quarantine. key to evidence statements and grading of recommendations, using the ranking of the canadian task force on preventive health care. classification of recommendations † i: evidence obtained from at least one properly randomized controlled trial a. there is good evidence to recommend the clinical preventive action ii- : evidence from well-designed controlled trials without randomization b. there is fair evidence to recommend the clinical preventive action ii- : evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group c. the existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making ii- : evidence obtained from comparisons between times or places with or without the intervention. dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the s) could also be included in this category d. there is fair evidence to recommend against the clinical preventive action iii: opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees e. there is good evidence to recommend against the clinical preventive action l. there is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making ⁎the quality of evidence reported in these guidelines has been adapted from the evaluation of evidence criteria described in the canadian task force on preventive health care [ ] . †recommendations included in these guidelines have been adapted from the classification of recommendations criteria described in the the canadian task force on preventive health care [ ] . ⁎the quality of evidence reported in these guidelines has been adapted from the evaluation of evidence criteria described in the canadian task force on preventive health care [ ] . †recommendations included in these guidelines have been adapted from the classification of recommendations criteria described in the the canadian task force on preventive health care [ ] . the most common non-obstetric infection during pregnancy is pneumonia [ ] [ ] [ ] , and in a series of studies, it is the third most common cause of indirect obstetric death [ ] . in the pre-antibiotic era, maternal mortality was as high as % [ ] ; more recently, it is reported to be less than % [ , ] . nonetheless, approximately % of pregnant patients with pneumonia will require ventilatory support in a critical care unit [ ] . viral pneumonia is associated with higher morbidity and mortality than bacterial pneumonia responsive to antibiotics [ ] . physiologic changes in pregnancy, including altered cell-mediated immunity [ ] and alterations in pulmonary function [ ] [ ] [ ] , are hypothesized to affect the susceptibility to and severity of pneumonia. the most detailed reports of viral pneumonia are of cases caused by influenza or varicella. the influenza epidemic of had a maternal mortality rate of % to % [ , ] . during the - asian flu epidemic, the maternal mortality rate was twice that of non-pregnant women, with a higher rate in the third trimester [ ] . ten percent of all deaths related to this influenza epidemic were in pregnant women [ ] . the most common fetal complications arising from maternal pneumonia include prematurity resulting from preterm labour (up to %), intrauterine growth restriction (up to %), intrauterine demise (up to %), and neonatal demise (up to %) [ ] [ ] [ ] . furthermore, midtrimester exposure to certain viruses (such as varicella) may cause embryopathy and multiple congenital anomalies [ , ] . by may , a total of cases of sars had been reported in pregnant patients from hong kong [ ] . hypoxia, resulting from sars-related acute respiratory distress syndrome, led to early pregnancy loss in of the cases. to help protect the fetus, pregnant women were given supplemental oxygen to maintain maternal arterial saturation above %, and kept in an upright position. women receiving mechanical ventilation were maintained in the left lateral position to maximize uterine blood flow. fetal status was monitored using cardiotocography, and ultrasound examination was used to monitor growth and doppler flows. all pregnant patients were treated empirically with broadspectrum antibiotics (e.g., clarithromycin, amoxicillin-clavulanate) to prevent secondary bacterial infections. ribavirin was reserved for patients with the most severe forms of the illness. as there is no evidence for ribavirin being effective in treating sars, it is currently not recommended [ ] . high dose pulse corticosteroids were administered in several cases [ ] . two deaths occurred in pregnant patients receiving high dose steroids in association with multi-drug resistant staphylococcus aureus (mrsa) septicemia. the pregnant women thought to be at risk for preterm birth were given additional dexamethasone as prophylaxis for the fetus. pregnant patients with sars were isolated from other antenatal and postnatal patients. a small core group of personnel were assigned to care for these patients exclusively, and all used strict respiratory precautions (such as the use of n masks or the equivalent), special gowns, and negative air pressure circulation at all times. the outcomes in pregnant sars patients in hong kong appeared to be worse than outcomes in their non-pregnant counterparts. of the seven cases followed at the designated sars unit, two died ( %), and four ( %) were admitted to intensive care for mechanical ventilation. this is in contrast to mortality rates of less than % and mechanical ventilation rates of less than % in non-pregnant, age-matched counterparts. fortunately, there was no clinical or laboratory evidence of sars in any of the babies delivered in this series. no conclusions could be drawn about the safety of planned early delivery by the vaginal route compared with caesarean delivery, or regional anaesthesia compared with general anaesthesia. however, for the most severe cases, caesarean delivery and general endotracheal anaesthesia were elected in order to avoid emergency airway issues and to minimize exposure risk for others. as with mothers infected with hiv, sars-affected patients were advised against breastfeeding in case of possible vertical transmission of the virus. there is no evidence that ribavirin is effective in the treatment of coronaviruses or sars [ , , ] . furthermore, there is evidence of severe toxicity in sars patients as a result of treatment with ribavirin [ ] . in canada, ribavirin is no longer recommended for treatment of sars [ ] . in vitro evidence suggests a role for the use of human recombinant interferons α, β, and γ in the treatment of sars [ , ] . their use in the clinical setting of sars in pregnancy requires further investigation. a review of the hong kong experience provides important information. for example, all pregnant patients with sars were managed in one unit at a designated maternity hospital. at one institution with a referral-based obstetrics and gynaecology service, the administration coordinated a transfer arrangement of sars patients to the designated sars hospital [ ] . all non-urgent ambulatory and elective gynaecological/surgical services were suspended. the overall number of staff was limited, and only a specific subgroup was assigned to the care of sars pregnant patients. communications among medical personnel were by phone or by electronic mail, and teaching conferences were suspended. clinical teaching was limited to avoid unnecessary exposures. infection control teaching modules were developed for all obstetrical staff, and all workers were routinely screened for symptoms and signs of infection. labour triage and antenatal hospital admission actions • assessment is made as to whether the patient has suspected or probable sars [ , ] • upon arrival in the labour and delivery triage unit, pregnant patients presenting with fever n °c and respiratory symptoms and one of the associated symptoms (cough, unexplained hypoxia, shortness of breath, or dyspnea) and history of an exposure to an individual with probable sars are immediately transferred to the designated isolation room, which is equipped with negative pressure ventilation. this may be a sars unit in the case of epidemic exposures. if necessary, procedures and delivery may be performed in this isolation room • a detailed travel and contact history is obtained from the patient • all staff and visitors should wear the following protective items before entry to the room: • consider administration of stress-dose corticosteroids for mothers treated with steroids antepartum to prevent addisonian crisis • to reduce perinatal infection, the newborn should have early clamping of the umbilical cord and early cleansing to remove maternal blood and amniotic fluid • all neonates born to mothers with sars should be admitted to the designated negative pressure isolation room in the neonatal nursery • present anaesthetic options to labouring mother; neither epidural nor spinal anaesthesia is contraindicated and in some cases may be preferable to general anaesthesia. in cases where mothers are already ventilated, general anaesthesia for delivery may be most appropriate postnatal management actions • the mother should not breastfeed until she has recovered from sars • to minimize neonatal transmission risk, the mother should be isolated from the neonate until she has recovered from sars and is considered no longer infectious • support should be given to the mother and her family to cope with separation from her neonate, potential prolonged maternal hospitalization, parenting issues, neonatal nutrition, and breast engorgement • as separation of mother and neonate may last for less than days, breast pumping is recommended so that breastfeeding may begin once isolation has been discontinued actions • neonates should be admitted to the isolation ward of the neonatal nursery for observation and are considered as potentially infectious until days post-delivery • preliminary testing for sars should be performed, including blood tests and x-rays • the infant should not be breastfed/given breast milk; formula should be used until the mother is considered no longer infectious. • parents and family are counselled to look for symptoms and signs of sars in the mother and newborn, especially in the first days following delivery suggested management guidelines for pregnant women with suspected sars labour triage and antenatal hospital admission actions • initial assessment and management is the same as for pregnant women with probable sars • if patient does not have symptoms, then placement in a negative pressure isolation room is not needed • the patient should be monitored for symptoms and signs of sars for a -day period • asymptomatic mothers with a history of sars exposure should be monitored closely for symptoms and signs (e.g., temperature measured - times daily), and they should be transferred to the negative pressure isolation room if symptoms or signs develop • if symptoms or signs develop, delivery, whether vaginal or caesarean, should occur in the designated sars delivery room, which is equipped with negative pressure ventilation • asymptomatic mothers with a history of sars exposure should be monitored closely for symptoms and signs (e.g., temperature measured - times daily) and transferred to the negative pressure isolation room if symptoms or signs develop • the mother should not breastfeed until she has recovered from sars or is deemed not to have sars • to minimize neonatal transmission risk, the mother should be isolated from the neonate until she is no longer potentially infectious • support should be given to the mother and her family to cope with separation from her neonate, potential prolonged maternal hospitalization, parenting issues, neonatal nutrition, and breast engorgement • as separation of mother and neonate may last for less than days, breast pumping is recommended so that breastfeeding may begin once isolation has been discontinued neonatal resuscitation • neonates born to mothers with potential sars close contact are considered to be potentially infectious until days postpartum • preliminary testing for sars is performed on the neonate only if mother or neonate has symptoms or signs of sars • if the mother remains asymptomatic, consider discharge of the neonate with the mother • parents and family are counselled to look for symptoms and signs of sars in the mother and newborn, especially in the first days following delivery, and to report to any findings to the health care team summary sars, a life-threatening respiratory illness caused by a novel coronavirus, was responsible for a worldwide outbreak in . sars has been responsible for serious illness in over canadians and for deaths since . given the highly infectious nature of sars, diagnosis, treatment and containment procedures must be aggressively pursued in all medical communities to prevent epidemic spread. special consideration must be given to the labour and delivery ward where mothers, their babies, and families are potentially placed at risk by exposure to an infected individual. in addition, special procedures must be instituted to protect labour and delivery personnel, who may have prolonged contact with labouring women and substantial exposure to body fluids at the time delivery and neonatal resuscitation. this document outlines a suggested management strategy for pregnant patients with sars on the labour and delivery ward. this protocol may be of use for other emerging life-threatening infectious diseases. the quality of evidence reported in this document has been assessed using the evaluation of evidence criteria in the report of the canadian task force on preventive health care (table) . caesarean section) should be managed in a designated negative pressure isolation room, by designated personnel with specialized infection control preparation and protective gear. (iii-c) . either regional or general anaesthesia may be appropriate for delivery of patients with sars. (iii-c) . neonates of mothers with sars should be isolated in a designated unit until the infant has been well for days, or until the mother's period of isolation is complete. the mother should not breastfeed during this period. (iii-c) . a multidisciplinary team, consisting of obstetricians, nurses, pediatricians, infection control specialists, respiratory therapists, and anaesthesiologists, should be identified in each unit and be responsible for the unit organization and implementation of sars management protocols. (iii-c) . staff caring for pregnant sars patients should not care for other pregnant patients. staff caring for pregnant sars patients should be actively monitored for fever and other symptoms of sars. such individuals should not work in the presence of any sars symptoms within days of exposure to a sars patient. (iii-c) . all health care personnel, trainees, and support staff should be trained in infection control management and containment to prevent spread of the sars virus. (iii-a) . regional health authorities in conjunction with hospital staff should consider designating specific facilities or health care units, including primary, secondary, or tertiary health care centres, to care for patients with sars or similar illnesses. 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cord_uid: alor ymh pollution represents a leading threat to global health and ecosystems. systems-based initiatives, including planetary health, ecohealth, and one health, require theoretical and translational platforms to address chemical pollution. comparative and predictive toxicology are providing integrative approaches for identifying problematic contaminants, designing less hazardous alternatives, and reducing the impacts of chemical pollution. pollution represents a leading threat to global health and ecosystems. systems-based initiatives, including planetary health, ecohealth, and one health, require theoretical and translational platforms to address chemical pollution. comparative and predictive toxicology are providing integrative approaches for identifying problematic contaminants, designing less hazardous alternatives, and reducing the impacts of chemical pollution. despite growing awareness of the detrimental impacts of chemical pollution since the release of rachel carson's silent spring over years ago, pollution remains a leading determinant for noncommunicable diseases and premature deaths globally. synthetic chemicals used in pesticides, pharmaceuticals, and residential and industrial settings are of particular concern because of rapidly increasing rates of production and diversification, complex human and environmental exposure scenarios, and a lack of universal pre-market toxicity evaluation. as a result, increasing volumes of synthetic chemicals with unknown human and ecological toxicity are entering water supplies, food production systems, the atmosphere, and cities and settlements throughout the world. as agents of global change, synthetic chemicals have been increasing in both variety and volume at a more rapid rate than other stressors, including co emissions and nutrient pollution. the chemical industry (the second-largest manufacturing sector in the world) is currently valued at >$ trillion each year, and sales are projected to double from to , as noted in the united nations (un) global chemicals outlook ii report. between and , the volume and capacity of chemical production grew rapidly in asia, and most of the future chemical production will occur in emerging economies ( figure ). implementing environment and health protection systems that are effective and sustainable and achieving pre-market toxicity evaluations throughout global chemical supply chains present grand challenges of growing importance. these challenges will most likely be exacerbated in the coming decades by rapid urbanization. an additional . billion people will live in cities by , and the majority of growth is projected to occur in low-and middleincome countries, which are already disproportionately affected by the burden of pollution-related diseases. concentrated resource consumption and chemical use in cities result in concentrated waste streams from urban regions. currently, % of global sewage goes untreated, and raw sewage and treated effluent discharges to surface waters of various quality are concentrated in cities. these waters are then reused for diverse purposes, including food production. the tightly linked food-energy-water nexus on which cities rely can therefore result in important human and ecological expo-sures to chemical pollutants, often of unknown toxicity. addressing global chemical pollution challenges, such as trajectories involving complex chemical mixtures, multiple stressors, and non-communicable diseases, requires systems-based approaches. in recent years, planetary health, ecohealth, and one health have emerged as multidisciplinary initiatives that embrace systems thinking to examine inherent connections across environmental quality, animal health, and human health in conceptually similar, though subtly different, ways. each of these holistic concepts focuses on the human-animal-environmental interface with a common goal of protecting health. aligned with these initiatives, comparative and predictive toxicologywhich have emerged from systems biology, computational chemistry, and pharmacology-are providing theoretical frameworks, translational methodologies, and interdisciplinary bridges to support and advance the goals of planetary health, ecohealth, and one health. here, we explore advances in and applications of comparative and predictive toxicology and how these are accelerating progress toward the common goals of systems-based environment and health initiatives. toxicology has historically relied on descriptive in vivo studies with mammalian models (e.g., rodents) to support chemical assessments for protecting public health. however, such assessments can be costly, time consuming, and ethically challenged from an animal welfare perspective. given that currently > , chemicals and mixtures of chemicals are registered for production and use in commerce globally, and these numbers are growing, safety evaluations must be performed in a timely manner. simply stated, we cannot evaluate so many chemicals by using traditional mammalian toxicology methods because of time and financial-resource constraints. addressing global pollution dictates more urgency. fortunately, advances in comparative and predictive toxicologyincluding research and regulatory shifts toward in vitro and in silico approaches and the increasing use of alternative animal models (e.g., zebrafish embryos)are helping to address the ethical, economic, and time constraints of traditional toxicology while also advancing mechanistic understanding. whereas comparative toxicology aims to understand chemicals that elicit common adverse outcomes across species, predictive toxicology routinely employs computational and other non-animal approaches to improve chemical hazard and risk assessments. these advances are further permeating in ecological applications aimed at prospectively (i.e., before a chemical goes to market) and retrospectively (i.e., after contamination has occurred) assessing and managing the impacts of chemical pollution. comparative and predictive toxicology methods are gaining regulatory acceptance at the international level as a result of recent advances and human relevance. for example, the use of mammals for skin sensitization testing of chemicals has been common practice for many years, but earlier this year the un globally harmonized systems agreed that researchers can use data from non-animal tests to classify chemicals that corrode or irritate skin. and in europe, in vitro testing has been used for identifying hazardous chemicals for diverse adverse outcomes and for selecting compounds in preclinical settings. these regulatory measures illustrate how comparative and predictive toxicology are facilitating transitions from traditional toxicology methods and are poised to address chemical pollution. as a prime example, recent -omics advances are set to transform the process of decision making for environmental protection by more rapidly identifying new or existing chemicals that require management in a more cost-effective and timely manner. for example, concentration-dependent transcriptomics approaches with fish models provide efficient tools for prioritizing chemicals of concern and for making management decisions according to the responsiveness of evolutionarily conserved biological pathways in human cells and fish models. high-throughput in vitro and in silico toxicology in ecotoxicology and environmental toxicology, in vitro methods are now being used for metabolism studies to better elucidate chemical bioaccumulation in fish, an important component of environmental risk assessments for ecosystems and human health (i.e., ingestion of contaminated fish). as the science continues to develop, so has the ability to relate chemical concentrations that induce in vitro responses to in vivo exposure levels resulting in adverse human and ecological outcomes. for example, comparable with in vivo results, toxicogenomic data generated in vitro are already yielding drug rankings and drug potentials to cause toxicity while guiding the selection of appropriate animal species with human relevance. well-developed in vitro methods are also increasing confidence among scientists and regulators in the resource and ethical advantages of in vitro predictiveness and extrapolation to animals. further, these methods offer valuable mechanistic information for training and testing a new generation of in silico models that use big data or modeling of molecular interactions to identify problematic chemicals and design less hazardous alternatives. some of the most active comparative and predictive toxicology efforts in the us include the federal toxicology in the st century (tox ) and toxicity forecaster (toxcast) programs (http://www. epa.gov/chemical-research/toxicologytesting- st-century-tox ). through tox and toxcast, thousands of chemicals are being screened with hundreds of in vitro assays (largely adapted from drug-development and pre-clinical safety efforts) and zebrafish models for identifying chemical bioactivities. such highthroughput information is supporting computational efforts to identify chemicals of potential concern. in addition, these and other toxicology advances are being leveraged for prospective evaluations of diverse substances-including ingredients in consumer products, industrial chemicals, and pesticides-for human and ecological hazards and during retrospective assessments (e.g., effectdirected analysis) for the identification of pollutants and other stressors in aquatic and terrestrial ecosystems. one earth , april , ll alternative vertebrate models because of their molecular, biochemical, and physiological similarities to humans, mammals (particularly rodents) have historically been used for biomedical research in general and toxicology in particular. but more recently, various fish species have been increasingly employed as vertebrate alternatives to rodents for toxicology, pharmacology, and etiology studies of human disorders. notably, approximately ten new drugs discovered by zebrafish screenings have reached, or are about to enter, clinical testing thus far. fish are now commonly used in laboratory investigations, which are supported by well-developed comparative biology resources. similar to in vitro tools, fish are more cost and time effective than mammals and aid in reducing animal welfare concerns. the more rapid development and reproduction of fish than of mammals provide clear benefits during high-throughput screening of a large number of chemicals. not only are fish pragmatic, ecologically important, and able to serve as a sentinel species, but also evolutionary relationships among fish and mammals allow fish models to provide advantages in molecular mechanistic studies because they offer opportunities for extrapolation across species. as noted above, recently developed diverse technical resources (such as sequenced genomes, dna libraries, and available antibodies) further support using fish for biomedical studies. fully established genome databases of zebrafish and the fathead minnow indicate high evolutionary conservation in comparison with the human genome. for example, % of protein-coding human genes are related to genes found in zebrafish, and many mutant phenotypes are similar to human clinical diseases. evolutionary conservation of pharmacology and toxicology targets for chemicals among species has supported the development of various tools (box ) to support the rapid and efficient evaluation of chemical toxicity. for example, sequence alignment to predict across species susceptibility (seqapass) is an online tool that supports toxicological predictions across species and the identification of problematic chemicals. such information can also aid the development and application of new comparative and predictive tools. one relevant example is transgenic fish models, which are being used as alternatives to transgenic mice in genome manipulation for comparative biomedical studies, functional genomic research, and comparative studies of relevance to human health and the environment. genetic engineering strategies combined with in vivo imaging of fish larvae are also allowing researchers to observe, in a non-invasive manner, real-time multi-scale responses to pharmaceuticals and chemical contaminants that would be difficult to detect with mammals. these transgenic fish models, when combined with in vitro bioanalytical tools and targeted and non-targeted analysis of chemical contaminants in the environment, present unique opportunities to diagnose specific sources and causative agents associated with chemical pollution. thus, human health and ecologically focused studies with fish models are reciprocally benefiting each other, which is likely to further enhance protection efforts for public health and ecosystems from pollution. addressing global chemical pollution in the st century presents a number of grand challenges for achieving the united nations sustainable development goals. fortunately, recent developments in comparative biology, computational chemistry, and pharmacology are being translated to provide basic and applied environment and health information to decision makers and practitioners in government agencies and industries, particularly within the adverse outcome pathway (aop) framework. aops are conceptual models that can be used for understanding chemical activity and potential effects with available knowledge to describe causal linkages from molecular initiating events to adverse outcomes at the individual and population levels, which are relevant to chemical risk assessment. aops can also be extended to higher levels of biological organization and for examining cascading interactions among trophic positions. when aops are conserved across species, comparative and predictive toxicology efforts promise to further develop coupled ecological and human health hazard and risk assessments. these efforts are particularly needed for chemicals of emerging concern, such as the per-and polyfluoroalkyl substances and diverse toxins from harmful algal blooms. efforts to prevent pollution are being informed by comparative and predictive toxicology advances for the identification of chemical bioactivity profiles, the evaluation of specific contaminants of concern, and the protection and restoration of ambient environmental conditions. because environmental management systems and waste treatment infrastructure commonly found in developed regions are not being consistently implemented or are lacking in low-and middle-income countries, ''disruptive'' technologies (such as contributions from sustainable, green chemistry and engineering) will increasingly be necessary to reduce the environment and health risks from chemical pollution. for example, the sustainable molecular design of organic chemicals is fueling innovation by supporting the identification of problematic contaminants, supporting chemical substitutions, and rationally designing de novo substances that are less persistent, bioaccumulative, and toxic. ecosystems and human populations are consistently exposed to complex chemical mixtures and multiple stressors. we must better understand the cumulative risks of, and interactions among, chemical, physical, biological, and social stressors during development and implementation of management efforts to protect public health and the environment. for example, how chemical contaminants influence the susceptibility of plants and animals, including humans, to bacterial, viral, and parasitic infections is not being routinely examined. as we watch the current global coronavirus disease (covid- ) pandemic unfold, non-communicable diseases resulting from pollution could elevate the impacts of respiratory viruses. identifying mechanisms to facilitate cross-cutting research among infectious disease researchers and comparative and predictive toxicologists appears warranted. advances in comparative and predictive toxicology are providing mechanistic insights and tools for designing less hazardous chemicals before they enter commerce, identifying problematic substances currently in production, and diagnosing causes of chemical pollution. as such, these toxicology advances are simultaneously building integrative foundations to advance the goals of the planetary health, ecohealth, and one health initiatives in addressing global pollution. however, strategic cooperation at both the educational and research levels, including non-traditional partnerships, is needed to foster connections and to integrate often disparate disciplinary pursuits via systems-based approaches. toxicologists and chemists need to more closely engage the broader planetary health, ecohealth, and one health communities to define and manage the growing global threats from chemical pollution. this need has been evidenced in part through the global horizon scanning project, an initiative with the society of environmental toxicology and chemistry (and the american chemical society in north america) that has engaged scientists, engineers, and stakeholders around the world to identify priority research questions aimed at achieving more sustainable environmental quality. most, if not all, of these key research questions are relevant to planetary health, eco-health, and one health; however, a number of priority research questions are directly related to comparative and predictive toxicology. these research questions largely focus on chemicals and other environmental stressors, and rather than being moon shots, they will require shorter-term multidisciplinary team projects to reverse engineer progress toward addressing a number of grand challenges for public health and ecosystems. key research questions from six continents highlight comparative and predictive toxicology connections with global environment and health challenges, as well as sustainable, green chemistry and engineering opportunities. clearly, these timely research needs should be addressed through systems-based initiatives. the ecodrug database (http://www.ecodrug.org/) includes information on the evolutionary conservation of human drug targets in > eukaryotic species. it supports the identification of these targets for > , drugs and the exploration of integrated ortholog predictions for drug targets across taxonomic groups. seqapass (http://www.epa.gov/chemical-research/sequence-alignment-predict-across-species-susceptibility) extrapolates from data-rich organisms (e.g., humans, mice, rats, and zebrafish) to thousands of non-target species to evaluate their specific potential chemical susceptibility. sensitivity of a specific species to a chemical is determined by a number of factors, including the presence or absence of proteins that interact with chemicals. it evaluates similarities of amino acid sequences and protein structure to identify whether protein targets are present for chemical interaction in other species. the computational toxicology (comptox) chemicals dashboard (https://comptox.epa.gov/dashboard) is an online tool that integrates diverse information, including physicochemical properties, environmental fate and transport, exposure, usage, in vivo toxicity, and in vitro bioassay information, for > , substances. it provides a resource to aid the rapid and efficient evaluation of chemicals. the adverse outcome pathway (aop) wiki (https://aopwiki.org/) is the primary repository of qualitative information for the international aop development effort coordinated by organisation for economic co-operation and development (oecd). it describes an aop in terms of key events (kes), which represent measurable steps along a pathway, ranging from a molecular perturbation to an adverse outcome for an organism or population. kes are connected via ke relationships (kers), which capture evidence supporting the aop in a structured way. the aop wiki provides access to aop information via an online interface that supports browsing and searching for aops, kes, kers, and stressors known to perturb the aops. the oecd quantitative structure activity relationship (qsar) toolbox (http://www.oecd.org/chemicalsafety/risk-assessment/ oecd-qsar-toolbox.htm) was developed to facilitate the accessible and transparent use of qsar models. it provides a decision support system for chemical hazard assessment. it aims to avoid duplication of animal toxicity testing, promote intelligent testing strategies, predict chemical toxicity of categories, and support green chemistry and sustainable development. the monarch initiative database (https://monarchinitiative.org/) uses semantics to integrate cross-species gene, genotype, variant, disease, and phenotype data. it provides a platform for exploring phenotype-based similarity across species and performing inter-species gene-phenotype anchoring analysis. the lancet commission on pollution and health synthetic chemicals as agents of global change urbanization, environment and pharmaceuticals: advancing comparative physiology, pharmacology and toxicology global, regional, and country level need for data on wastewater generation, treatment, and use a comparison of three holistic approaches to health: one health, ecohealth, and planetary health toward a global understanding of chemical pollution: a first comprehensive analysis of national and regional chemical inventories omics advances in ecotoxicology in vitro to in vivo extrapolation for drug-induced liver injury using a pair ranking method going all in: a strategic investment in in silico toxicology zebrafish earn their drug discovery stripes the zebrafish reference genome sequence and its relationship to the human genome quantitative cross-species extrapolation between humans and fish: the case of the antidepressant fluoxetine editor's highlight: sequence alignment to predict across species susceptibility (seqapass): a web-based tool for addressing the challenges of cross-species extrapolation of chemical toxicity adverse outcome pathways: a conceptual framework to support ecotoxicology research and risk assessment environmental dna shaping a new era of ecotoxicological research redesigning hazardous chemicals by learning from structure-based drug discovery toward sustainable environmental quality: priority research questions for north america key: cord- - lakgpxp authors: yoon, sung‐won title: sovereign dignity, nationalism and the health of a nation: a study of china's response in combat of epidemics date: - - journal: stud ethn natl doi: . /j. - . . .x sha: doc_id: cord_uid: lakgpxp this paper seeks to understand the role of nationalism in china's policy towards the combat of emerging infectious diseases. by locating nationalism as a factor which facilitates or impedes global governance and international collaboration, this paper explores how nationalism influences china's political decision‐making. given her historical experience, china has in its national psyche an impulse never to become ‘the sick man of the east’ again. today, china's willingness to co‐operate with international bodies emanates out of reputational concerns rather than technical‐medical considerations. this was clearly manifested in her handling of two epidemics in recent years: the severe acute respiratory syndrome (sars) and hiv/aids episodes. this paper concludes that china's nationalism plays an inhibiting role in china's attempts to further incorporate herself into the architecture of global health governance in the long run. as well as a regulatory approach to a new disease outbreak. sars demonstrated that simple divisions between national and global health policy do not work in practice. during the outbreak, governments had to realise that a disease in any one part of the world is a threat to the rest of the world. however, ironically governments were in general reluctant to acknowledge the existence of the outbreak. most notably, the chinese government's response to sars was critical to the functioning of global governance in infectious disease control. it is a classic textbook example and a fundamental test case of how nationalism can impede or facilitate global governance and international collaboration. china had initially covered up the outbreak, but later reversed its stance to fully co-operate with the world health organization (who). scholars viewed china's initial response to sars within the context of china's poor public health infrastructure, ineffective and fragmented bureaucratic system, and political transition in leadership at the time of the outbreak. at the same time, china's remarkable u-turn towards international collaboration was demonstrated in the framework of the tremendous power of international organisation (i.e. who) in facilitating china's submission and the changing nature of international politics where sovereignty has been curtailed (eckholm : ) . some scholars have even gone further to argue that china's sars episode demonstrated the governance transition from westphalian to post-westphalian strategies (fidler ; ). yet, despite some scholars' claims based on china's initial reluctance and subsequent acquiescence to international forces, there is no evidence that china's sovereignty has been curtailed or that china has been integrated into global health governance. while the existing literature has focused on china's stunning reversal during the sars outbreak, less attention has been paid to the extent to which this turnaround has continued during the aftermath of sars. indeed, in light of the chinese leadership's attitude and commitment towards other infectious diseases such as hiv/aids and the recent cases of avian influenza, china's newfound openness did not seem to be genuine. this leads to the following questions: what were the factors that inhibited and then facilitated the collaboration during the outbreak? what eventually brought china back to 'business as usual' after the outbreak? what ultimately motivates the government's agenda and actions towards infectious diseases? this paper argues that nationalism in the form of national pride and security consciousness in china are enduring driving forces that have studies in ethnicity and nationalism: vol. , no. , shaped chinese policy towards emerging infectious diseases. by locating nationalism as a factor which facilitates or impedes international collaboration, this paper explores how the chinese leadership has exhibited ways in which nationalism affected much of their political decision-making in their quest to restore national pride and to secure china's developmental goals and national interests. it is argued that more often than not, nationalism hindered the formulation and implementation of health policy at both the provincial and national levels. maintaining a positive image of china in the international arena and securing the interests of the regime were key driving forces that affected policy-making. more specifically, this usually revolves around the ruling elites' competency in the handling of a national crisis and in its foreign policy. given the historical experiences of china, it has in its national psyche an impulse never to become the 'sick man of asia' again. the reaction of the chinese authorities at both the central and provincial levels towards unknown health threats is often to deny and cover up the disease's existence. this could be in part to avoid the stigma of being a 'sick' nation as well as to buy time in order to search for an indigenous solution to the problem. this sort of mentality belies a negotiated basis of existence behind the modern chinese nation -as if to say that there are no problems that modern china cannot handle or solve. yet it is also the same desire to appear 'healthy', 'confident' and a 'responsible' member of the international community that often swings chinese response to disclosure and collaboration. however, the latter only happens when the disease in question and china's handling of it is put under international scrutiny and often criticism. in short, china's compulsion to co-operate with international bodies emanates out of reputational concerns rather than medical considerations. nationalism can then be rapidly conjured up as a force which legitimises the draconian measures taken in the name of the nation to defend its sovereignty. one of the most immediate effects is that public health threats are often securitised and political-security solutions are sought rather than technical-medical ones. this means that any information pertaining to the outbreak is treated as classified, and is revealed on a 'need to know' basis, and collaboration is discouraged. it also means that the development of treatments is often seen as an opportunity to showcase the work of indigenous scientists who are 'able' to come up with a cure. an interrelated point pertains to the prospect of china's integration into global health governance. unless and until the chinese leadership examines the nationalistic element embedded in their approach towards growing disease sung-won yoon: sovereign dignity, nationalism and the health of a nation epidemics and globalising health challenges, china's ascendance to great power status will actually be harmed rather than helped. history is replete with examples of nationalist wars, where historical enemies and entire cities were wiped out, territories annexed and glory won, often at an exorbitant cost. history is equally manifested with examples where massive genocide has taken place in the name of the nation to realise some deranged nationalist blueprint, such as hitler's efforts to achieve a pure and superior aryan race or pol pot's infamous year zero project to restart civilisation in pursuit of a communist utopia. yet, such apocalyptic devastation is not always wrought by genocides or wars, but often through inaction, ineptness or impotence by national leaders who fail to defend the nation against aggression, man-made disasters, and pandemics. just as the great athenian statesman pericles learnt from the athenian plague in the fifth century bc and the roman emperor marcus aurelius from the outbreak of smallpox, epidemics could besiege large segments of any given population with quick and lethal consequences on a scale far greater than imperialistic wars or disastrous famines. the primitive state of medical science, limited understanding of hygiene, poor sanitary conditions, and widespread poverty often enable plagues and epidemics to thrive and spread with ease. the plague of justinian (sixth century ad), the black death (fourteenth and fifteenth centuries ad), and the bubonic plague ( - ) stand in testimony throughout the ages to remind the world of the imagery of the four horsemen of the apocalypse described in revelation : : 'and i looked, and behold, a pale horse; and his name that sat on him was death, and hell had followed him'. it was not until the advent of modern advances in science and technology that the verse was more associated with nuclear weapons than with epidemics. since the peloponnesian war in bc, when a plague that originated in ethiopia spread to the persian empire and to athens, the world has seen nation-states combat these epidemics at a localised and, at most, a national level (hays : ; porter ; watts ) . health policy on disease epidemics was a matter of sovereign discretion and exclusively dependent on the concerned nation's capabilities. when the black death (bubonic plague) in the fourteenth century spread through international travel and trading routes afflicted europe and north america, quarantine measures aimed exclusively at preventing disease threats from entering a nation from outside its borders were taken in major european nations. as in defence or foreign policy, health policy is most certainly an exclusive jurisdiction of the national government or ruling regime, and on numerous occasions, great rulers who have built their empires on military conquests have seen their legitimacy to rule crumble very quickly with the unbridled spread of pandemics in their nations. religion, as opposed to science, became the salvation from diseases and epidemics until the eighteenth century. nonetheless, the combat of plagues and epidemics has always invariably been seen and recognised as a national 'problem' for leaders, even though pathogens, bacteria and epidemics in general have no respect for political borders or sovereign rights over territory or people. however, as the rapid growth of populations and intensified human interactions in the sixteenth century and the process of industrialisation from the eighteenth century offered many communicable diseases opportunities to spread more widely, nations began to contemplate types of global response. one dimension of this response was a nascent form of international conferences. these early conferences were widely supported by the economic and political elites, as they believed that the spread of epidemic diseases would hamper the expansion of trade and the development of commerce. therefore, in retrospect, most nations' responses to epidemics were not born out of historically nationalistic gestures underpinned by a statist discourse to protect and defend against westphalian notions of sovereign dignity. instead, the nations' responses were traditionally based on more rationalistic and interest-based considerations. elites regard the protection of the nation's health to be of paramount importance, sometimes not so much to defend the citizen's right to life or liberty, but out of a less altruistic desire to ensure that the state's interests are maintained (e.g. keeping the economy vibrant, harvesting crops, maintaining troop levels, and rendering services and goods). as norman howard-jones observed, the very first international health conferences in the nineteenth century were not motivated by a wish for the general enhancement of the world's health, but by the desire to protect certain favoured (european) nations from contamination by their less favoured (eastern european) counterparts (howard-jones : - ) . therefore, earlier forms of collaborative action illuminated these politicians' concerns about the impact of outbreaks on their nationals and, in particular, the rationale that underpinned the sense of nationalism behind the ruling elite's orientation towards healthy policy. one of the fundamental pillars of understanding in the westphalian notion of sovereignty in the modern fraternity of nation-states is the very fact that sung-won yoon: sovereign dignity, nationalism and the health of a nation all nation-states are sovereign entities, with their own jurisdiction over territories and peoples. extrapolating from this, all nations are therefore born 'equal' in this fraternity of nations, as enshrined in article of the charter of the united nations that membership in the un is 'based on the principle of the sovereign equality'. the stark reality is that the members in this community of nations can hardly be equal. we hear of 'great powers' all the time, as much as we hear of the influence of the 'bi-polar' or the 'uni-polar' world. the logic that drives and motivates nations in this fraternity today is the quest to become 'great', and this desire for nationalism underpins most nationalist thinking and discourse within any given state. while there is no definite statistical evidence for this, it would not be an exaggeration to say that most nations wished that they could at least play in the finals of the world cup. for that matter, americans beam with pride as the us is consistently regarded as the only superpower left in the world, just as a significant number of russians look back nostalgically with pride to a glorious past. the french are convinced that they are the most superior civilisation and culture left in the world, and point to the vibrancy and the romance of their capital, paris, and the french dominance in luxury and designer goods industry. it is also quite clear that the chinese are extremely proud of their economic rise and perceive the hosting of the olympic games as a sign that it has made it in the world. in short, nations thrive on pride and sovereign dignity. most nations regard themselves as 'strong', founded on science, rationality, and progress. this vocabulary is found not only in discourse pertaining to health but also politics and economics. a healthy nation is strong, resilient, and able to withstand any political, economic, or health crisis. in , the french medical community thought that the disease creating havoc in the eastern mediterranean would never affect france, expecting that it be confined to weaker and less civilised populations experiencing a poor and unhealthy climate. the cholera killed , people in four days in paris (delaporte ) , thus confounding most of the elites. today when political leaders speak of a healthy nation, they more often use 'health' as an analogy to draw comparisons, alluding to their aspirations for the country to be strong in all dimensions. the 'health' of a nation is therefore founded on both symbolic and substantive terms, and they are often intertwined in reality. in symbolic terms, a 'sick' nation is one that is weak. tsar nicholas i described the crumbling ottoman empire as the 'sick man of europe', just as russia has been tagged with the same label in the last two decades after the demise of the soviet union. in asia, one saw the japanese labelling the decaying qing china the 'sick man of east asia'. qing china was not only weak economically, militarily, and politically, but was also plagued by internal stifle, unrest, and opium addiction. the most potent symbol of this 'sick man of east asia' was the imagery of chinese men hooked on opium, a drug introduced by the british to reduce its trade deficit as its demand for chinese tea, silk, and porcelain increased. this imagery has underpinned various versions of chinese nationalism ever since. william a. callahan ( ) eloquently discusses the role of shame in chinese nationalism. as callahan argues, nationalism in china very often commemorates its weaknesses rather than celebrating the glories of chinese civilisation ( : ) . the official narrative of modern china is generally a tragic tale of its fall from being the 'centre of the universe' beginning with the opium wars, to the incursion of western powers into imperial china, to the grand finale of the invasion of china by the japanese. this is intricately linked with the rise of the communist party of china (cpc) and the founding of the people's republic of china (prc), and provides the very basis of the legitimacy with which the cpc stakes its political right to reign. it is this deeply seeded shame that motivates the modern chinese state never to fall behind again -whether in economic or political terms -as modern china seeks to erase the 'shame and humiliation' today. this quest for greatness is a significant impetus for china's economic rise. in essence, 'achievement' is used as a remedy to get rid of the shame that china has written into much of its official discourse over the past developmental trajectory. one need not look far for evidence. china's national anthem written in (translated below), one year after the japanese invasion of china, poignantly documents the sense of shame behind the 'sick' nation: arise, ye who refuse to be slaves! with our very flesh and blood, let us build our new great wall! the peoples of china are in the most critical time, everybody must roar his defiance. arise! arise! arise! millions of hearts with one mind, brave the enemy's gunfire, march on! brave the enemy's gunfire, march on! march on! march on! sung-won yoon: sovereign dignity, nationalism and the health of a nation numerous scholars have documented how the obsession with 'humiliation' and the goal of turning 'grief' to 'strength' have significantly influenced china's foreign and security policy towards the united states and japan (dittmer and kim ; gries ; shambaugh : - ) . one of the most important dimensions is china's obsession with sovereignty or perceived infringements of her sovereignty or pride. this has made china hypersensitive to any sort of international criticism, it as an infringement of her sovereignty or meddling in her internal affairs. obviously one could argue that this is a political strategy of the cpc to deflect any sort of political challenge, but given the rise of nationalism within china over the last decade, one cannot help but realise that these sentiments might be more widespread than conceived. while china maintains a discourse of equality and camaraderie of friendship with other nations of the world, its actions and its policies often belie china's real intention of ascendance and greatness. as such, china is not only concerned with building capabilities associated with a great power, it is also extremely concerned with portraying an image that it is one. most interestingly, china's obsession with sovereign dignity and pride and its place in chinese nationalism is clearly manifested in its handling of two health-related issues: china's approach towards the handling of the aids epidemic and its response to the sars epidemic in - . the impulse for china's reticence on sars perhaps the most pertinent question discussed in this paper is why the chinese leadership tried to cover up the extent of sars and later took decisive action. answering this entails an understanding of a number of factors, but it is argued that nationalism and sovereign dignity played a part in china's response to sars. despite all the changes that the country has undergone, the traditional so-called 'face-saving' approach seemed to be as intact as ever and even deeply engrained in the mentality of the chinese leadership. therefore, when there is an event that could damage national pride, it is highly embarrassing for them to admit. the best way to resolve the troublesome event is to actively avoid or deny. thus the mode of dealing with national calamity is to identify a problem before the outside world discovers it, take measures to address it, and only afterwards report the improved situation. these mechanics have been generally at the heart of the chinese leadership's crisis management, particularly with regard to emerging infectious diseases. this was evident in china's response to sars. the crucial feature of the sars outbreak in china from early january through early february was that the provincial authorities kept the lid on the situation. the cpc has tended to suppress negative news such as diseases and disasters out of fear that such information would disrupt national stability. cover-ups are usually started by local officials who want to avoid embarrassment in front of their superiors due to their incapability to control the situation themselves. therefore, there is no incentive for local officials to pass the information up the chain of command. when early cases occurred in guangdong province, the local authority was at least aware of the situation. anxious to avoid criticism for their mishandling of earlier outbreaks and in an effort to maintain guangdong as a location of commercial dynamism and economic growth, the provincial leaders concealed the gravity of the disease. later, provincial party secretary zhang dejiang, the highest-ranking official in guangdong, stated: 'if we made a contrary decision, it would have been impossible to achieve a gdp growth rate of . per cent' (cctv interview, june ) . this denotes the fact that the guangdong leadership feared the impact of the disease's outbreak on national development. the potential 'loss of face' also contributed to provincial leaders' concealment, as the disastrous public health problem would eventually contribute to the negative effects on the cpc's legitimacy. sars was considered something that needed to be defeated before it became embarrassing. therefore, the suppression of information at the provincial level was not only motivated by development goals for the nation but was also prompted by the desire to save face and maintain reputation. once the virus spread internationally, the nature of the problem and the possibilities for resolution broadened significantly. when the chinese government failed to address the growing epidemic, the health problem in china became a political issue and an embarrassment for the central government. however, the central government's long-overdue response to growing infectious diseases was not reversed abruptly. beijing's initial reaction to the epidemic was silence and an unwillingness to co-operate. until early april , an international team of experts was not permitted to investigate hospitals in beijing. china's health minister zhang wenkang declared at a press conference that there were twelve sars cases in beijing but claimed that the disease had not spread to other parts of china (abraham : ) . the discourse that sars was under control was also backed by hong tao, the esteemed chinese microbiologist, who asserted that the cause of the disease was chlamydia and that the outbreak was dying down. due to sung-won yoon: sovereign dignity, nationalism and the health of a nation systematic problems in the chinese scientific community -a lack of coordination; stifling political influence; hesitation to challenge authorities; and isolation from the rest of the world -the chlamydia hypothesis was firmly established in china (enserink : ) . when the world-leading scientific labs confirmed that the causative agent was a coronavirus that had never before been seen in humans, china's persistent assertion had to be withdrawn. it was another national embarrassment that the emerging power was short of a scientific solution. there was a major turning point on april . faced with widespread international criticism of china's unresponsiveness, president hu jintao and premier wen jiabao finally declared a war against sars, calling for accurate and timely information about the disease to be provided and shared amongst units and international partners. this announcement was widely reported by chinese newspapers and television. shortly after the declaration, health minister zhang wenkang and beijing mayor meng xuenong were dismissed, ostensibly for their inadequate response to sars. premier wen went on to attend the asean-china leaders meeting in bangkok on april and stated that 'the chinese government is here in a spirit of candour, responsibility, trust and cooperation' (macan-markar ) . in hindsight, as the country's reputation suffered abroad, the leadership needed to re-establish itself as a responsible member of the international community in the eyes of its international counterparts. having exposed the emerging power's incapability of handling a disease crisis, the only way of restoring national pride was to show the world that the great china had the capacity to deal with the national threat efficiently and effectively in a short period of time. the chinese leadership made a lot of effort to inform the general public of the dangers of sars and to mobilise society in the name of the 'national' spirit. depicting the combat against sars as a 'baptism of fire' for the entire nation and urging the public to unite around the communist leadership to defeat the national crisis, the chinese government set up the 'sars control and prevention headquarters of the state council' headed by vice premier wu yi. the government created a fund for new building projects and the provision of more healthcare services (balasegaram and schnur, : ) . amazingly, the government was able to build a dedicated hospital for the treatment of sars within a week. apart from government initiatives, the propaganda department made an effort to 'nationalise' a regional outbreak into a national crisis and, in doing so, mobilised an entire nation into the battle against sars virus. the people's daily ( may ) used traditional maoist revolutionary rhetoric, such as calling for the people to 'build out a new great wall -on the great spirit of the fight against sars' (ren zhongping, ) . the propaganda department worked towards alerting the people about the disease and instilling in every individual a sense of patriotism and national duty to rally around the cpc. in guangxi province, minority groups sang songs about sars; in inner mongolia, murals were painted to depict the sars experience; and in beijing, banners spurred comrades on, harkening back to mao's campaigns during the cultural revolution (balasegaram and schnur : - ) . having decided to be transparent, the media sprung into full action with reports of 'whitecoated warriors' and 'angels in white coats', describing heroic stories of doctors and nurses working for love of their nation and its people. community leadership also re-introduced the traditional neighbourhood committee by revitalising the grassroots party structure. this committee, mainly consisting of elderly residents, barred outsiders and checked for sars symptoms in their neighbourhood. these committees created groups of ten households and appointed one volunteer. the volunteers were in turn grouped in tens and reported to a higher authority. this structure continued upwards until it meshed seamlessly with the communist party system that ruled the country (south china morning post ) . yet, what is important to note here is that this nationalism extends beyond making sars an immediate enemy of the nation. the image of a china being 'sick', the inability of chinese scientists and people to eradicate the virus independently, the ineptness of the chinese health system to effectively contain the outbreak were all smudges on the chinese image that the leadership wanted erased. by encouraging the national spirit and mobilising the energy of the entire population, the government was able to show the international community that china in fact had the capacity to deal with the national crisis, thereby restoring the national pride and dignity that was commensurate with china's international reputation and image as a rising great power. the success of this reversal did ameliorate the damage done to china's image by its previous bungling. china's handling of the sars crisis, unfortunately, does not represent its approach to epidemics in general. scrutinising the prc's approach to the hiv/aids epidemic in the country, china's reticent approach to international co-operation is clear. compared to the recent sars episode, the aids epidemic has been around for more than two decades. although its sung-won yoon: sovereign dignity, nationalism and the health of a nation effects are less 'visible' than the sars outbreak, in reality, the aids epidemic is probably more devastating and has had a much higher death toll than sars. aids, however, did not receive much attention from the central authorities until very recently. however, the actual number of aids carriers is believed to be much greater. the inaccuracy of the estimate is due to the fact that there is massive underreporting of the disease, especially the rural areas. there are many reasons for underreporting, but a shortage of adequate resources and a lack of openness in confronting the epidemic at many levels of government (provincial and local levels) are some of the major factors that contribute to china's slow response. exact figures are difficult to gauge because the government at the local level is very reticent to report on actual cases (human rights watch ). when aids was first reported in beijing in , the initial cases were treated with disdain and the disease was labelled as 'foreign'. the government warned that young women having sexual relations with foreigners could be in danger, and that 'foreigners' would facilitate aids becoming an epidemic in the prc. the government also tightened immigration controls and required all foreign students entering china to present a certificate from their country of origin testifying that they were not infected with aids. during the s, although aids began to spread from yunnan province to other parts of country, the chinese government officially denied that it had an hiv/aids problem. this was exposed as a lie by a few whistleblowers, at least one of whom was imprisoned for revealing 'state secrets' (watts : ) . therefore, the real extent of hiv/aids cases remains unknown as the government's long-standing position towards this epidemic has always been that aids is a 'foreign' disease requiring surveillance and border control, as well as action against social undesirables such as prostitutes, drug users, and blood brokers. the chinese government's response to aids was initially persistent silence and a refusal to acknowledge that the issue was serious. a major factor behind the government's recent change in its attitude towards the aids epidemic seemed to be the outbreak of sars in china in studies in ethnicity and nationalism: vol. , no. , , which exposed the dangers of not reacting to emerging infectious diseases. yet, it took almost two decades and a lot of pressure, internationally and domestically, before the chinese government decided to institute measures to 'contain' the aids epidemic. despite some candidness surrounding the discussion of aids in china, the scale of the problem is still being played down, mainly due to the government's tight control on media and infected aids patients not coming forward for fear of discrimination. thus the true extent of the problem remains unclear. yet, the chinese government was actually forced to address the aids epidemic for reasons very similar to those that led to the disclosure of the sars epidemic. it was sparked by the revelation of the very controversial case of an entire aids village in henan province, where thousands of poor farmers were infected by hiv while selling blood to the health authorities. initially the villagers were isolated and ostracised, and local authorities acted in the name of the national interest and the public good to cover up this outrageous negligence on the part of the health authorities. due to the mounting weight of evidence that china is in the grip of a major epidemic, the chinese government came under tremendous international criticism for their inaction over aids. the government seems to have increased efforts to fight aids by reversing some policies. despite enhanced intervention measures and infrastructure, stigmatisation, fear, and hidden infection constitute a vicious circle that fuels the aids epidemic in china. the prevalent societal attitude in china towards aids was and still is very prejudiced. aids is regarded as a 'foreign' disease and is associated with promiscuity, perversion, and homosexuality. hiv carriers are shunned by society as social outcasts and are seen as 'deserving' the disease because of their 'morally' decadent lifestyles. according to a survey conducted in china, seventy-five per cent of respondents said they would sung-won yoon: sovereign dignity, nationalism and the health of a nation avoid hiv/aids carriers and forty-five per cent responded that the disease was a consequence of moral degeneration (the un theme group on hiv/ aids in china ). the dominant narrative in china of these unknown diseases is characterised by a lack of understanding and education, and is 'nationalistic' in the sense that biological threats and diseases are still perceived by the majority of people to be 'foreign', even though germs do not respect political boundaries. it is very unlikely that health policy towards epidemics will be reconfigured overnight without a corresponding change in societal attitudes and government perceptions. there are other factors at work that have prevented the chinese state from addressing the aids issue openly and candidly. chinese nationalism has often compelled the chinese state to securitise any issue it perceives to be damaging to its national interests. the literature on aids has long highlighted that it is a significant security threat. significantly, other than the direct impact of aids on the constituent population, aids has grave consequences for the 'affected' nation. aids heightens the prospect of wars internally and externally and hollows out military and state capacities, weakening both to the point of failure as this is a disease that targets the most economically active and demographically most reproductive segment of any nation's populace (singer ) . moreover, aids will also have a tremendous and significant impact on the demographics of the population, as the disease has demonstrably killed off the most productive and strongest segment of the population first, rather than the infirm and weak segments. aids will dramatically increase health costs per capita within a relatively short period of time. it could possibly affect prospects for inward investment and long-term economic development. the chinese state realises that the aids epidemic might well have more disastrous and far-reaching consequences than previously thought. yet, at the same time, the chinese government realises that the inability to handle and contain any epidemics would have repercussions for their legitimacy to govern internally and china's reputation externally. given china's historical experiences, china has an obsession with sovereign dignity which has been rigidly built into her strategic and political culture. china therefore has a propensity to construe issues critical to china's interests as a zero-sum game, as the chinese outlook is very much influenced by neorealist thinking. this has rendered china hypersensitive to any threats and often to frame its responses to any challenges to its well-being by securitising these challenges. as such, china's initial reaction to the infectious diseases is most distinctly characterised by securitising the disease, as opposed to taking a biomedical and technical approach. china's incomplete turnabout on aids is in large part due to her reticence and inability to adjust her approach to perceive aids as something beyond a security issue. this is also significantly highlighted in the sars episode. right from the beginning of the sars outbreak, information about the disease was deemed to be a state secret. divulging data regarding infectious disease outbreaks could make one a defendant in a treason case (saich : ) . therefore, there was no reason to go public regarding a curious incident or with rumours of a new disease. despite recent changes, china is still characterised by its obsession with the notion of security and much information remains confidential, including information about infectious diseases. the scope of classified information is wide and can be flexibly applied to anything considered related to national security (human rights watch/asia and human rights in china : - ) . while a regulation had amended a regulation that classified high-level infectious diseases as highly secret with the secrecy extending from the first occurrence of the disease until the day it was announced, infectious diseases still remained national security matters. when a report on earlier cases of sars was produced in january in guangdong, the report was labelled neibu or 'top secret', which meant that information about the situation must be kept among only the highest national officials (human rights watch/asia and human rights in china : ). the classification of sars as a secret may have been motivated not only by the post-cold war legacy (i.e. their obsession with security), but also the leadership's desire to hide from other nations vulnerable issues which could be regarded as national threats. in order to deal with the national secret, the top officials needed to close the lid tight. an array of actions and policies demonstrated this. for example, the ministry of health explicitly ordered the heads of beijing hospitals to report sars only through channels upward on a confidential basis but not to any media. according to one ministry of health official, they had been told by higher levels that the outbreak was a closed matter: 'this came from quite high up in our ministry. . . . we did not have that information and once we were told that the outbreak was officially closed, we could not secure cooperation' (greenfeld : ) . hiv/aids has been securitised in much the same way as sars. aids activists in china have been either detained or arrested by the chinese officials for 'harming the state security' or 'revealing state secrets' sung-won yoon: sovereign dignity, nationalism and the health of a nation (benjamin kang lim ) . with regard to releasing official figures on aids patients, the government withheld information from the public while they checked political matters and prepared for immediate economic repercussions. national interests and security maintained precedence over transparency. this sort of 'secrecy' with regard to national security issues is typical of post-communist regimes and of most countries. it also characterises what might be a first response for any country that is sensitive to the judgement of international opinion. interviews with the chinese scientists involved in the aftermath of sars revealed that many of them felt that it was a great shame that the virus was not first identified by chinese scientists, since the virus outbreak occurred primarily in china and the majority of the victims were chinese (ensernik : - ) . in fact, many of the scientists were frustrated by the way information was 'partitioned' and the epidemic 'securitised'. yet, it is not only that securitisation of this epidemic that would pose a problem. a more important problem is how the prc elites could possibly believe that there could be a response other than a bio-medical solution to a health threat. this situation may be slowly changing as the chinese government becomes more amenable to outside co-operation as long as their regime and defined national interests are not compromised. there seems to be an inverse correlation between china's propensity to cooperate internationally and her desire to protect her core national interest and national aspiration i.e. reunification with taiwan. this aspiration is intricately linked to the regime's legitimacy and political survival and if threatened would lead the chinese government to become more hardline and nationalistic, and less willing to discuss any form of cross-border cooperation. the sars episode saw the regime's legitimacy challenged by the fact that the authorities appeared to be quite inept at handling the crisis, but more importantly the sars episode was also politicised as a reunification and a security issue. chinese nationalism complicated the handling of this medical crisis across the taiwan straits. preventing taiwanese independence has been a foremost chinese national priority. in that respect, china has consistently exerted tremendous political and diplomatic pressure to prevent taiwan from gaining membership in any international organisation. taiwan has made seven efforts to join the who. china insists that taiwan is an 'inalienable' part of china and should therefore not be recognised as an individual entity. when sars cases mounted in taiwan, the taiwanese government asked the who for assistance. in response to this, zhang wenkang, china's minister of health, stated: 'we hope that the leaders of taiwan authority no longer spread rumours with ulterior motives, or even use the disease as an excuse and in the name of human rights to try to enter the who, which is only opened to sovereign nations' (mirsky ) . this symbolised china's long-standing position towards taiwan, which denies taiwan's place in the international system. but it also reflected how chinese leaders regarded sovereignty issues over other impending issues such as the immediate crisis of the epidemic. for china's leadership, the health crisis was no longer a health issue but a political one. there is no guessing how the ruling elites would choose when deciding between political survival and enhancing international co-operation. the process of globalisation significantly impacts the socio-political context of health. emerging infectious diseases, in particular, have triggered the political aspect of public health because the threat of the trans-border spread of disease challenges the traditional state-centric approach to infectious disease policy. the pathogenic threats highlight the inability of states to act alone to prevent the spread of infectious diseases amid globalisation. as a consequence, emerging infectious diseases have forced a reconceptualisation of public health governance both nationally and globally, leading to an increase in the process of global collaboration. the concept of global health governance has therefore emerged in this context, characterised by the relative decline in the salience of states alone and the increased involvement of new ways of norm setting and compliance processes. the question that this article considers is whether nations and national dignity have been virtually impacted and eventually weakened by the new health governance mechanism which is able to set and control the rules of health at a global level. it is argued that global health governance may influence the nation's response to the threats posed by emerging infectious diseases such as sars or aids as a mode of building political compromises but does not considerably alter the nation's behaviour, at least for china. it is argued that in case of china, sovereign dignity and nationalism outweighed the global values in the response to infectious diseases. the chinese government's initial silence on sars and aids, and its lack of co-operation despite its awareness of the extent of the epidemic, demonstrated the nature of national pride inherent in china's response to national crisis. in pursuit of national prosperity through foreign investment and international trade, any discourse or narrrative on potential disasters such the sars or aids epidemics would naturally be suppressed at the first instance. in addition, the chinese leadership's obsession with issues of national security further allowed the sars virus to spread across the world. no one could disclose information about the epidemic unless they had security clearance, because sharing information pertaining to or even acknowledging the existence of any infectious disease is regarded as a crime by revealing 'state secrets'. if anything, the sars and aids episodes have shown that the existence of epidemics cannot be contained by censorship, regulation or legislation alone. however, once the information about the sars outbreak was divulged, the growing epidemic was beyond the national public health capacity, and to make matters worse, other nations began to criticise china's unresponsiveness, the chinese government had to institute 'damage control' measures by denying that it had any role in intentionally concealing the disease's existence. this would undoubtedly further damage china's national pride and dignity by announcing to the world that china was not able to deal with domestic public health problems. by the same token, the chinese government therefore had to show the international community that as an emerging power, it could still address the public health crisis, this time through mobilising the nation to participate in international efforts to stem the epidemic. with the help of international health expertise, china was able to successfully curb the sars epidemic in a very short period and with remarkable efficiency. its successful efforts somewhat ameliorated the embarrassment it caused itself by the bungled handling of the disease outbreak, and to a certain extent restored some of its lost national pride and international reputation. in the aftermath of the incident, china's successful story of controlling sars was a sign that china was incorporated into the global health governance where international health problems are resolved for the greater global public good. it seems, however, that china's leadership was only prepared for limited and selective openness. in light of china's response to recent cases of avian influenza, the need to preserve an infallible national image still takes precedence over public health concerns in the minds of china's leaders (cyranoski a: - ; cyranoski b cyranoski : . indeed, the incidents surrounding reporting of avian influenza in china clearly demonstrate how the chinese government has hindered progress towards halting the epidemic, denied the presence of an outbreak, prevented the exchange of information on the flu virus, and allegedly promoted widespread misuse of antiviral vaccination in chickens. scientists were often faced by less than cooperative local and central officials, whose primary concern was how health problems would negatively impact on national development goals. therefore, china's long tradition of avoiding sensitive questions and denying negative developments has yet to change. rather, it appears that national pride in a great china invariably contributes to the national response to emerging infectious diseases. in an era of rapid globalisation, it remains uncertain to what extent the chinese leadership's concern with nationalism and sovereign pride would modify itself to fit into the global governance if a more serious threat posed by a new transnational but more lethal disease than sars emerges. clearly, china's national pride and security would do little to further the achievement of china's incorporation into global health governance, not to mention the health of 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international sanitary conferences locked doors: the human rights of people living with hiv/aids in china sars strengthens china-asean ties joint united nations programme on hiv/aids, and world health organization containing sars: the scandal over taiwan', international herald tribune health, civilisation and the state: a history of public health from ancient to modern times building our new geat wall -on the great spirit of resisting and attacking sars', people's daily, may is sars china's chernobyl or much ado about nothing? beautiful imperialist: china perceives america neighbourhood watchers join sars battle hiv/aids: china's titanic peril aids in china: new legislation, old doubts epidemics and history: disease, power, and imperialism summary of probable sars cases with onset of illness from sung-won yoon is a phd candidate at the who collaborating centre on global change and health, london school of hygiene and tropical medicine (lshtm). prior to coming to lshtm, she completed her graduate studies at seoul national university and ewha womans university in korea. sung-won has worked as a policy researcher for various korean universities, think-tanks and the parliament of the republic of korea for several years, principally researching on social and health care issues. she was awarded a fully funded research fellowship by the korean government to undertake research work at london school of economics and political science before she embarked on her work at lshtm. key: cord- -l ro v authors: tsai, alexander c; venkataramani, atheendar s title: us elections: treating the acute-on-chronic decompensation date: - - journal: lancet public health doi: . /s - ( ) - sha: doc_id: cord_uid: l ro v nan www.thelancet.com/public-health vol october e as the usa nears the presidential election, the country remains confounded by a confluence of population health and economic issues. there are regional epidemics of unsuppressed severe covid- . the country is experiencing a sustained period of economic contraction resulting from local policy (eg, stay-at-home orders) and spontaneous collective physical distancing responses to the covid- epidemic. both of these burdens are inequitably borne by black, latin, and american indian communities, whose disproportionate killings by police have been widely known but only recently highlighted in the sustained, widespread protests in support of the black lives matter movement sparked by george floyd's killing earlier this year. whether us citizens choose to re-elect president donald trump or replace him with former vice president joseph biden, the next president faces an overwhelming amount of work. the next presidential administration needs to recognise that the covid- pandemic in the usa represents a set of acute derangements overlaid upon a chronic erosion of health and wellbeing. the usa is currently in the middle of a -year population health crisis, having long ago diverged from the population health trajectories of other high-income countries. unprecedented socioeconomic and racial/ethnic disparities in population health decline are occurring in tandem with stagnating economic outcomes as well as spiking income and wealth inequality. , a burgeoning literature identifies restricted economic opportunities-the fading of the american dream-and growing economic insecurity as the primary reasons for the worsening metrics in population health and economic wellbeing. as in clinical medicine, such acute-on-chronic decompensation is potentially reversible when identified early and treated aggressively. reversing the underlying chronic decline in population health and economic wellbeing will require either legislative solutions or executive orders to enhance economic opportunity and promote population health. to continue the analogy from clinical medicine, evidence-based treatment would include raising the minimum wage, strengthening labour unions, and providing affordable childcare, health insurance, and paid parental or medical leave that are not contingent on employment. , these evidencebased approaches have been shown to broadly improve health and economic outcomes. more substantive changes to labour and housing markets, immigration policy, and the carceral system will be needed to directly benefit black, latin, and american indian populations, who have long borne the brunt of deeply entrenched structural racism in the usa. , such policies would substantially support the acute covid- response in the usa. a patchwork of state and local social distancing measures has filled the void left by the current administration's leadership failure. this state of affairs has led to economic problems among individuals with unstable, low-paying, and lowquality jobs that offer neither paid medical leave nor work-from-home possibilities and among individuals whose living arrangements do not lend themselves to social distancing or isolation. people in stable, highpaying occupations have, by contrast, continued to accumulate wealth through savings and capital gains while safely working from home and relying on so-called essential workers for delivery of their basic needs. looking beyond the covid- pandemic, we call on the next administration to enact structural changes to ensure that the patterns of the past are not repeated in the future. universal access to primary education, in which quality of education is not conditioned on one's zip code of residence, will be needed to close persistent racial and socioeconomic gaps in economic, health, and social outcomes. for people who choose not to obtain a secondary education, the quality of manufacturing and other jobs needs to be strengthened, so that meaningful participation in the economy is not conditional on having a college degree. , furthermore, more federal investments are needed to expand the supply of affordable housing-particularly in rural areas, in formerly redlined neighborhoods, and on tribal landsso that more people have access to this primary engine of intergenerational wealth creation. unfortunately, the costs of policy implementation will be incurred immediately, whereas the economic, health, and social benefits will not be realised until years later. our recommendations therefore run counter to existing political incentives and will admittedly require boldness and courage, motivated by outrage, to enact. but from the perspective of economic wellbeing and population health, both acutely and chronically, none of understanding covid- risks and vulnerabilities among black communities in america: the lethal force of syndemics stolen breaths economic influences on population health in the united states: toward policymaking driven by data and evidence association between automotive assembly plant closures and opioid overdose mortality in the united states: a difference-in-differences analysis minimum wages and racial inequality the mark of a criminal record the return to the sacred path: healing the historical trauma and historical unresolved grief response among the lakota through a psychoeducational group intervention social distancing to slow the us covid- epidemic: longitudinal pretest-posttest comparison group study racism and the political economy of covid- : will we continue to resurrect the past? deaths of despair and the future of capitalism racial residential segregation: a fundamental cause of racial disparities in health key: cord- -k y t i authors: gómez-salgado, juan; andrés-villas, montserrat; domínguez-salas, sara; díaz-milanés, diego; ruiz-frutos, carlos title: related health factors of psychological distress during the covid- pandemic in spain date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: k y t i measures to prevent and contain the covid- health crisis include population confinement, with the consequent isolation and interruption of their usual activities. the aim of the study is to analyse psychological distress during the covid- pandemic. for this, a cross-sectional observational study with a sample of people over the age of during quarantine was developed. variables considered were sociodemographic variables, physical symptoms, health conditions, covid- contact history and psychological adjustment. the data were collected through a self-developed questionnaire and the general health questionnaire (ghq- ). bivariate analyses were performed, including chi-squared test and student’s t-test. predictive ability was calculated through logistic regression. results obtained showed a high level of psychological distress ( . %), with a higher percentage in women and people of lower middle age. statistically significant differences were found in the variable working situation (χ² = . , p ≤ . , v = . ) and living with children under the age of (χ² = . , p = . , v = . ). the predictive variables with the highest weight were sex (or = . , % ic = ( . , . )), presence of symptoms (or = . , % ci = ( . , . )), and having had close contact with an individual with confirmed covid- (or = . , % ci = ( . , . )). these results could enrich prevention interventions in public health and, in particular, in mental health in similar pandemic situations. coronavirus disease has created a rapidly widening health crisis with dramatic consequences. on december , the wuhan municipal health commission in china notified the world health organization (who) of cases of pneumonia of unknown origin [ ] . on january , who declared an international public health emergency following the covid- outbreak that began in wuhan, china. by that date, cases had been identified across different countries outside china [ , ] . following the increase in the spread to more than , cases in countries and deaths, on march , who reported its pandemic consideration [ ] . as a result of the rapid evolution of in spain, being female, younger, having negative self-perceptions about aging, being more time exposed to news about covid- , having more contact with relatives different to those with whom they co-reside, fewer positive emotions, less perceived self-efficacy, lower quality of sleep, the higher expression of emotion and higher loneliness have been associated with psychological distress during isolation measures as a result of the covid crisis [ ] . this variability in the risk and protective factors of psychological distress against covid- suggests the need for further epidemiological studies to consolidate the results. although there is agreement on the increase of psychological distress in the population during the pandemic, the characteristics of this situation are disparate, and the phenomenon is not yet clearly described [ ] . the objective of the study is to analyse the psychological distress in a spanish population sample during the covid- pandemic, identifying the predictive character and role that sociodemographic variables, the presence of physical symptoms, and other health-related variables may have. as a hypothesis, it is stated that the health crisis caused by covid- does not generate psychological distress in the population. this research employed a cross-sectional observational study design. the initial sample consisted of people, recruited between march ( days after the start of confinement) and april . as inclusion criteria for the participants, the following were established: (i) being years of age or older, (ii) living in spain during the covid- pandemic, and (iii) accepting the informed consent. questionnaires were eliminated for having a percentage of questions answered of less than %, which resulted in a final sample of participants distributed in provinces and the two small spanish autonomous cities located in north africa. based on the sociodemographic characteristics of the sample, . % were women and . % men. the distribution by sex of the spanish general population is . % women and . % men [ ] . the average age of the participants stood at . years (sd = . ). the most common marital status was married or living as a couple ( . %) followed by being single ( . %). most of the participants had university studies or higher educational level ( . %) and the . % had upper secondary education. demographic data of the general spanish population indicate that % of the population has university studies [ ] . in relation to the employment situation, the . % of the subjects were working away from home, . % worked exceptionally from home (teleworking), and . % were not working at the time of their participation in the studio. most participants ( . %) were spending covid- confinement in a flat or apartment and the . % was confined in a house. the . % of the participants stated that they lived with children or youngsters under the age of at the time of their participation in the study. lastly, . % indicated that they cohabited with people with disabilities. this study aims to collect information on varied dimensions to assess the mental health and associated behaviours of the general population so as to assess the impact of this health crisis. therefore, the dependent variable was psychological adjustment and as independent variables sociodemographic data, the presence of physical symptoms of covid- , participants' health status, and history of possible contacts or exposure to covid- were considered. the sociodemographic variables included were sex, age, marital status, education level, employment status, number of people living with, living with a child or adolescent, and living with a disabled person. the participants were asked about the prevalence of the most common symptoms of covid- indicated by who over the past days [ ] : fever equal to or greater than • c, cough, headache, myalgia, dizziness, diarrhoea, sore throat, coryza, chills, and difficulty in breathing. a self-developed questionnaire was designed including the symptoms as items and dichotomous responses ("yes/no"). in relation to the state of health, the level of the participants' current physical and mental health was assessed through dichotomous response questions ("yes/no") to the following items: suffering a chronic illness, having a disability, taking some medication, having been hospitalised in the last days, and having been attended by some health service in the last days. to this end, the process was based on wang et al. approach [ ] . an item with five response options was used to measure perceived health: very bad, bad, not so good, good, and very good. this indicator was initially proposed by ilder and benyamini [ ] and used with small variants, in subsequent pandemic research [ , , , ] . it was assessed whether the person was quarantined due to having had a risk contact or covid- infection, as well as whether they had had a covid test. the contact history was evaluated by three questions with three answer categories (yes, no, i don't know), which evaluate direct/indirect contact with infected people or with people or materials suspected of being infected. a fourth taxonomic item ("yes/no") assessed cohabitating with people at risk of being infected. psychological adjustment was measured through the general health questionnaire (ghq- ), a psychometric instrument widely used as a screening of non-psychotic psychiatric disorders [ ] . it consists of items with four answer options. each item can get a score of (if options or are chosen) or (if options and are selected), getting from its sum a total score ranging from to . this questionnaire developed by goldberg has been translated and validated in many countries, presenting cronbach's alpha values from . to . [ ] and demonstrating, in addition, a good reliability in its version for spanish speakers with . and . in the spanish population [ , ] ; it has also been previously used in other sars-like epidemics [ ] . for this study, the overall score was used as a single factor whose reliability, estimated by cronbach's alpha, was of . . the cut-off point set for the general population was , considering those subjects with scores greater than or equal to more prone to potential psychiatric morbidity cases [ , ] . the independent variables were assessed through a self-elaborated questionnaire. for the design of the questionnaire, a bibliographic review was carried out on the psychological effect that other epidemics, and their prevention measures, had had on the population in the past. with the accumulated evidence, a first version of the instrument was built and evaluated by a panel of experts made up of health professionals: three doctors, four nurses, and three psychologists, two of which were specialists in clinical psychology. after the appropriate modifications were made, piloting was carried out with participants, obtained through a sampling for convenience, all over years of age and with a similar proportion of men and women in the sample ( . % and . %, respectively) and an average age of . (sd = . ). most participants reported being married ( . %) and having completed postgraduate studies, whether a master's or doctoral degree ( . %). they were all asked to complete the survey from different electronic devices. none of the participants expressed comprehension problems or doubts about what they were asked, nor were there any errors regarding the platform or design on the different devices (personal computer, tablet or smartphone) used by the participants. data were collected through the online data collection and survey platform qualtrics ® xm. as a telematics application, the confinement measures decreed by the health alarm state did not affect data collection. the sampling method was through the "snowball" effect, initiated by sending the information through email lists to universities and professional colleges who were asked to facilitate their dissemination. the helsinki declaration [ ] has been taken into consideration. participation in the study was entirely voluntary, and the explicit permission of the participants was obtained through informed consent for the confidential use and processing of data, according to the current laws in force on the protection of personal data. data were stored anonymously, with the assignment of a registration number so that it was not possible to identify the participants' responses. the project was approved by the research ethics committee of huelva, belonging to the andalusian ministry of health (pi / ). the analyses were performed using the spss . version statistical software (ibm, armonk, ny, usa)-an initial descriptive analysis was performed by calculating the means and frequency of the variables. the presence or non-presence of psychological distress was studied in each of the independent variables. subsequently, bivariate analyses were performed, including chi-squared test and student's t-test for independent samples, depending on the type of variable. the size indexes of the crammer's v and cohen's d effect were also calculated with the following cut-off points: to . , negligible; . to . , small; . to . , medium; from . on, high [ ] . then, with the aim of studying the predictive ability for psychological distress of the different sets of variables, logistic regression analyses (controlled by sex and age) were carried out including variables with p value < . . thus, model included sociodemographic variables, and model was related to physical symptoms, model showed health-related variables, and model dealt with contact history. finally, those variables that showed a predictive character in each of the models were included in a global model (model ). odds ratios (ors) were calculated with a % confidence interval. table details the mean scores and standard deviations of the answers provided by the subjects in each of the questions that make up the ghq- . the results show that items "have you been constantly felt overwhelmed and tense?" (m = . ; sd = . ) and "have you been able to enjoy your normal activities every day?" (m = . ; sd = . ) were the ones with the highest score. on the contrary, the items that presented a lower score were the item "have you thought that you are a person who is worthless?" (m = . ; sd = . ) and item "have you lost self-confidence?" (m = . ; sd = . ). the average score obtained in the total of the points scale was . (sd = . ). establishing a cut-off point of or more points, the results showed that a . % of the study participants presented psychological distress. in the light of the sociodemographic variables (table ) , the results showed statistically significant differences between both groups as for sex (χ = . , p ≤ . , v = . ) and age (t = , p ≤ . , cohen's d = . ), though effect sizes were small. a greater presence of psychological distress was observed in women ( . %) and in persons of lower middle age (m = . , sd = . ) with respect to the group that did not present this psychic morbidity (m = . , sd = . ). statistically significant differences were also found regarding the variable working situation (χ = . , p ≤ . , v = . ) and in terms of living with children or youngsters under the age of (χ = . , p = . , v = . ). the highest percentage of psychological distress was observed among people who were working outside home ( . %), and a low percentage of psychological distress was observed among people living with children or youngsters under the age of ( . %). in relation to the presence of symptoms in the days prior to the participation in the study (table ) , more than half of the sample claimed to have had headache ( . %); cough ( . %), myalgia ( . %), sore throat ( . %), and coryza ( . %). to a lesser extent, subjects reported having suffered from diarrhoea ( . %), dizziness ( . %), chills ( . %), breathing difficulty ( . %), and fever higher than • c for at last one day ( . %). on the other hand, according to the number of symptoms, the highest percentage ( . %) stated that they had developed three or more symptoms in the days prior to their participation in the study, followed by . % of participants who had not developed any of these symptoms. similar percentages were among those who reported having had a symptom ( . %) and two symptoms ( . %). statistically significant differences were observed between the presence of physical symptoms and psychological distress (p < . in all cases). statistically significant differences were also found regarding the mean number of symptoms (t = − . , p ≤ . , cohen's d = . ), with an average effect size. the group of subjects with psychological distress had a higher number of symptoms (m = . , sd = . ), as compared to the group that did not present this psychic morbidity (m = . , sd = . ). based on health-related variables (table ) , . % of respondents reported suffering from some form of chronic disease. among these subjects, the most commonly reported diseases were high blood pressure ( . %) and chronic respiratory disease ( . %), and to a lesser extent diabetes ( . %), immunosuppression disease or situation ( . %), metabolic syndrome ( . %), chronic cardiovascular disease ( . %), and active cancer ( . %). referring to the need for medical care, . % of subjects reported having been hospitalised in the last days, and . % reported receiving healthcare at a health centre, clinic, or hospital. . % of participants reported being quarantined for covid- symptoms and . % reported the diagnostic test ( . % negative, . % positive, and . % do not know the result). the variables related to the presence of psychological distress were the need for healthcare in a health centre, clinic, or hospital (χ = . , p < . , v = . ), having been quarantined (χ = . , p < . , v = . ), and having been done the diagnostic test (χ = . , p < . , v = . ). for all of them, the size of the effect was negligible. lastly, and taking into account the subjects' assessment of their perceived health in the last days, the results also showed statistically significant differences between the two groups (t = . , p ≤ . , cohen´s d = . ), with an average effect size. the group of subjects with psychological distress expressed a worse assessment of their health (m = . , sd = . ), as compared to the group without psychological distress (m = . , sd = . ). in relation to contact history in the last days (table ), . % of participants reported having maintained or not knowing if they had maintained close contact with an individual with confirmed infection with covid- . . % of respondents claimed to have had casual contact, and . % said they had maintained or did not know if they had maintained contact with any person or material suspected of being infected with covid- . in relation to the presence of infected people in the participants' immediate circle, . % indicated not having a relative infected with the virus and . % said they did not live with any confirmed infected family members. all contact history variables in the last days showed a statistically significant relationship with the presence of psychological distress (p <. in all cases). however, the effect sizes were negligible. logistic regression analyses have shown an adequate adjustment in general and an explained variance of . % in the overall model, with correct classification percentages of each model around %, which has allowed to identify the predictive variables of psychological distress. logistic regression models, controlled by sex and age, are displayed in table . model (sociodemographic variables) showed a predictive ability of . % (χ = . , p < . ). the result of the hosmer-lemeshow test indicated that this model did not present a good fit (χ = . , p = . ). sex, specifically female (or = . , % ci = ( . , . )), age (or = . , % ci = ( . , . )), and employment situation were predictive, correctly classifying . % of subjects with sensitivity and specificity parameters of . % and . %, respectively. with model , regarding physical symptoms, the variance value explained amounted to . % (χ = . , p < . ). those participants who had a higher number of symptoms in the days prior to their participation in the study (or = . , % ci = ( . , . )) were more likely to present psychological distress. this model correctly classified . % of participants (sensitivity . % and specificity . %). model , which includes health-related variables, had a predictive capacity of . % (χ = . , p < . ), slightly higher than the previous model. this model provided sensitivity and specificity values of . % and . %, correctly classified to . % of the sample. however, it did not present a good fit (hosmer-lemeshow chi-squared value = . , p < . ). participants with a higher score in self-rated health (or = . , % ci = ( . , . )) were less likely to present psychological distress. however, those subjects who had recently been diagnosed with covid- were . times more likely to have psychological distress ( % ci = . , . ) . the contact history variables are included in model , which provided an explained variance rate of . % (χ = . , p < . ). having had a close contact with an individual with confirmed infection with covid- (or = . , % ci = ( . , . ) ), as well as having had any contact with any person or material suspected of being infected (or = . , % ci = ( . , . )) had predictive ability, correctly classifying . % of the participants ( . % sensitivity and . % specificity). finally, model (global model), which included the variables that had a predictive character in the previous models, presented a predictive ability of . %, correctly classifying . % of the participants ( . % sensitivity and . % specificity). the variables that showed the greater weight, with ors greater than , were sex (or = . , % ci = ( . , . )), number of symptoms presented in the last days (or = . , % ci = ( . , . )), having had close contact with an individual with confirmed infection with covid- (or = . , % ci = ( . , . )), and having had contact with any person or material suspected of being infected (or = . , % ci = ( . , . )). other predictive variables with ors less than were age, employment status, and self-rated health. in this study, various sociodemographic variables, variables related to the presence of physical symptoms, and other health-related ones have been identified as predictors of the presence of psychological distress symptoms among the spanish population during a period of health alert due to the covid- epidemic. in spain, during the initial moments of confinement, . % of the study participants showed risk of psychiatric morbidity (or distress). this figure is much higher than the ones found in previous studies carried out on the spanish population, that placed psychiatric morbidity at . % [ ] or . % [ ] , not having subsequent data [ ] . specific studies on the psychological impact during epidemics place the prevalence of psychological distress between . % and . % [ ] [ ] [ ] [ ] [ ] ] . in our study, the highest percentage level of psychological vulnerability during an epidemic can be found. these high results may be due to the fact that the covid- pandemic in our country has affected the spanish population in a more serious way than previous pandemics and the feeling of alarm is greater. as for the role that sex may play in relation to psychological vulnerability in epidemic situations, some studies have found that being male was associated with greater distress during the recovery period of sars [ ] but, in most studies, females were associated with greater vulnerability. women are found to suffer greater distress during the h n influenza outbreak [ ] or during equine influenza [ ] , and a longitudinal study on the impact of the sars outbreak in hong kong [ ] found that women were more likely to suffer anxiety. one of the first studies conducted during the covid- epidemic identified an increased risk of anxiety, depression, and stress among women [ ] . as for the general indicators of mental health in spain, being a woman is associated with greater vulnerability [ ]. our results are in line with those found in most studies, showing that women present significantly higher levels of distress (with low size effect), and this can therefore be understood as an individual risk factor in the face of the impact of the covid- epidemic. the results show that, although weakly, younger people are at higher risk of suffering higher levels of distress. these data are consistent with those from previous studies in epidemic states, and in which being younger was associated with an increased risk of distress [ ] or increased psychiatric morbidity [ ] . however, a study similar to the present one conducted at the beginning of the covid- quarantine identified an increased risk of psychological distress among people over years of age [ ] . mental health indicators in spain show that psychiatric morbidity increases with age [ ] . our data indicate that the youngest part of the study population is the one with the highest psychiatric morbidity. this result can be understood in line with sim [ ] and taylor [ ] , due to the relationship they establish regarding differences in coping styles. thus, youngest adults are less resilient in the face of adversity and also less able to understand that it is an extreme situation that implies radical and sudden changes in the lives of people, and which are not the result of an individual decision. as for the relationships found between the degree of distress and living with children during confinement, the data showed that people with children have a greater psychological vulnerability. however, the effect size was negligible. this result coincides with those by taylor's study [ ] which suggests that people with a child are more likely to have psychological distress, explaining that those who have a child are usually younger adults and hence the association with the greatest risk. on the other hand, as brooks [ ] and naushad [ ] state, there is no link between having children and any psychological impact in their reviews. however, mazza et al., in their recent study, conducted during the covid- crisis in italy, identified an association between having no children and a higher level of depression [ ] . in relation to the employment situation, most previous studies have analysed the role of economic income and its changes as a result of labour measures taken during an epidemic. thus, reduced or low level of economic income was consistently related to an increased risk of psychological impact [ , , ] . general indicators of mental health in spain show that low levels or lack of economic income, as well as lack of employment, are associated with lower mental health [ ] . our data, however, indicated, weakly, that in the pandemic situation by covid- , those who have to work away from home had a higher level of distress. this outcome can be related with a higher risk of contagion and concern for all its consequences, as they can spread the disease to the family and due to the high degree of uncertainty about the disease. in this line, mihashi's study [ ] shows how the perception of risk is associated with psychiatric morbidity during and after recovery of sars. on the other hand, the results obtained by jahanshahi et al. on the effects of covid- quarantine in iran suggest that participants who had to stop working because of the pandemic had more psychological distress than those who worked from home or at their workplace [ ] . quarantine for at least days is associated with increased anxiety and anger [ ] , as well as with increased symptoms of post-traumatic stress disorder [ , , ] . our data showed that quarantine was associated with increased psychiatric morbidity (negligible size effect). in the line posed by hawryluck et al. [ ] , being quarantined can be interpreted by these people like trauma or personal assault. our study coincides with previous ones associating perceived low health with a higher level of stress and psychological impact in general [ , ] . we have also observed, with an average size effect, that a worse perception of health was linked to increased psychiatric vulnerability. the presence of covid- symptoms was also related to the level of distress, so the presence of some symptoms can be considered a factor associated with increased psychological morbidity. the study on the psychological impact of covid- conducted by wang [ ] identified that myalgia, dizziness, chills, sore throat, and having a cold were associated with a greater psychological impact of the outbreak. additionally, the presence of covid- symptoms was associated with higher levels of stress, anxiety, and depression [ ] . similarly, during an outbreak of sars, the presence of symptoms such as fever was linked to the risk of higher distress, which can be understood on the basis that the onset of symptoms can reinforce the sense of vulnerability and threat of infection [ ] . the presence of mers symptoms was related to an increase in anger scores [ ] . also, testing and history of contact with infected people or objects were related, with negligible size effect, to increased psychiatric morbidity. no data from previous studies reveal the role that testing or diagnostic tests may play on the effects of psychological morbidity, but there are studies that indicate that the presence of risk contact may be a predictor of acute stress disorder [ ] or post-traumatic stress disorder [ ] , having found a relationship between anxiety and having had contact with materials suspected of being infected [ ] . our result can answer to what wu [ ] raised by showing that protective measures are often relaxed with close people such as family and friends. however, knowing that contact has been made with a person who has subsequently become ill increases the feeling of danger, similar to the risk of contracting the illness, also increasing psychological vulnerability. among the limitations of the study, as it is cross-sectional observational design which only informs of the perception at the time it was performed, it does not allow to establish cause-and-effect relationships but, on the contrary, it does provide with very valuable and difficult to obtain information about how the problem generated by the pandemic is lived just at the time of further escalation of the contagion curve, this being the largest contribution of the article. the sample collection was not randomised and the ratio by sex was asymmetrical and does not correspond to the distribution of the spanish population. these factors were compensated with a large sample and representation from all provinces and autonomous cities, having taken into account the variable sex in the analysis. comparing these data with those from other epidemics is difficult because the measures established in confinement or isolation are highly variable, even in different geographical areas within the same pandemic, variables that, as seen in this study, have a great influence in the development of psychological distress. it may be interesting to make other cuts of the study at a more advanced stage of the pandemic and at the end of the pandemic in order to assess its evolution. the study, conducted during the health alert decree with confinement measures at home except for essential activities, and initiated at the beginning of growth of the contagion curve, shows that a high percentage ( %) of participants had psychological distress, being this percentage higher among women ( . %). people who work outside home in essential activities are more likely to suffer psychological distress, and those who lived with children or under- youngsters were less likely to show this distress. the most common symptoms in the last days were headache, cough, myalgia, sore throat, and rhinitis; three or more symptoms are more commonly found. although one out of three participants had a chronic disease, only . % had required health care and less than one percent ( . %) required hospital care. a high percentage ( . %) claimed to have had contact or not knowing whether they had had contact with any infected person or material. however, a vast majority claimed not having had any infected family member ( . %) and not living with any infected family member ( . %). an association was found between psychological distress and a poor assessment of health. among the variables that predict psychological distress are, therefore: being female, age, employment situation, number of symptoms, perception of poor health, having been in close contact with an infected person, as well as having been in contact with people or material suspected of being infected. these results should be explored in depth and considered for awareness-raising and information programmes during pandemics or other crisis situations, as they could enrich prevention interventions in public health and, in particular, in mental health. the information provided by the present study can help to design interventions for the psychological and emotional recovery of the population after the pandemic. it can also help in the design of mental health prevention programs aimed to protect the population from psychological distress in case of future pandemics. the authors declare no conflict of interest. world health organization. novel coronavirus ( -ncov) situation report emergency committee regarding the outbreak of novel coronavirus ( -ncov) china coronavirus: who declares international emergency as death toll exceeds world health organization. who director-general's opening remarks at the media briefing on covid- - boletín oficial del estado real decreto-ley / . boletín oficial del estado multidisciplinary research priorities for the covid- pandemic: a call for action 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psicométricas y valores normativos del general health questionnaire (ghq- ) en población general española the general health questionnaire montero-piñar, i. morbilidad psíquica, existencia de diagnóstico y consumo de psicofármacos: diferencias por comunidades autónomas según la encuesta nacional de salud de statistical power analysis for the behavioral science salud mental en españa y diferencias por sexo y por comunidades autónomas psychosocial and coping responses within the community health care setting towards a national outbreak of an infectious disease longitudinal assessment of community psychobehavioral responses during and after the outbreak of severe acute respiratory syndrome in hong kong key: cord- -y fhubnc authors: maeshiro, rika; carney, jan k. title: public health is essential: covid- ’s learnable moment for medical education date: - - journal: acad med doi: . /acm. sha: doc_id: cord_uid: y fhubnc the covid- pandemic, an unprecedented challenge for this generation of physicians and for the health care system, has reawakened calls to strengthen the united states’ public health systems. this global event is also a “learnable moment” for medical education—an opportunity to decisively incorporate public health, including public health systems, through the continuum of medical education. although medical educators have made progress in integrating public health content into medical curricula, “public health” is not a phrase that is consistently used in curricular standards, and public health colleagues are not identified as unique and essential partners to improve and protect health. the covid- crisis has demonstrated how a strong public health system is necessary to support the health of patients and populations, as well as the practice of medicine. partnerships between medical and public health communities, through individual- and population-based interventions, can also more effectively combat more common threats to health, such as chronic diseases, health inequities, and substance abuse. to achieve a more effective medicine–public health relationship in practice, curricula across the continuum of medical education must include explanations of public health systems, the responsibilities of physicians to their local and state governmental public health agencies, and opportunities for collaboration. medical education should also prepare physicians to advocate for public health policies, programs, and funding in order to improve and protect the health of their patients and communities. pandemic covid- demonstrates with laser focus that all physicians are part of public health systems and that public health content has a distinct and critical place across the continuum of medical education to prepare physicians to participate in, collaborate with, and advocate for public health systems. for the vast majority of us, the onset of the covid- global pandemic in early was the beginning of an unparalleled time of uncertainty for the health of the nation and the capacity of our health care system. in the past, colleagues have weathered regional natural disasters, outbreaks of emerging infectious diseases, and terrorist attacks. although the events were formidable and, at the time, the extent of their casualties unpredictable, the victims of september , , and the anthrax attacks, for example, were treated by a limited corps of providers and institutions. in contrast, covid- has affected all of us and its duration is unpredictable. the demands for a stronger public health system are echoing back from previous emergencies. how the medical community will reflect and adapt in the wake of this pandemic is unknowable, but an early lesson for medical students, physicians, and educators is clear: public health content has a distinct and critical place across the continuum of medical education to prepare physicians to participate in, collaborate with, and advocate for public health systems. recommendations to secure a foundational position in medical education for public health, described by c.-e.a. winslow as "the science and art of preventing disease, prolonging life, and promoting health through the organized efforts and informed choices of society, organizations, public and private communities, and individuals," date back for generations and are included in the flexner report. public health includes quantitative sciences (biostatistics, epidemiology); social, behavioral, and environmental sciences; the study of health systems (health policy, financing, and regulation); clinical and community preventive services; leadership and communication skills; and contemporary disciplines and issues (e.g., informatics, genomics, preparedness) that together emphasize an ecological model of health. medical education standards across the continuum of training, including policies and recommendations from the liaison committee on medical education, accreditation council for graduate medical education, and specialty boards, have begun to include public health content, such as the application of biostatistics and epidemiology to evidence-based practice and quality improvement, social and behavioral sciences in the context of determinants of health, and the study of health care systems. the phrase "public health" is not necessarily included in this guidance, and public health systemsparticularly the responsibilities and structure of the governmental public health systems in which physicians practice-are rarely mentioned. content areas such as population health, social medicine, and health systems science overlap with public health, but we hope that our experience responding to covid- will put to rest the instinct to dilute public health with alternative labels. in , the institute of medicine (iom) reiterated winslow's perspective of public health by defining it as the covid- pandemic, an unprecedented challenge for this generation of physicians and for the health care system, has reawakened calls to strengthen the united states' public health systems. this global event is also a "learnable moment" for medical education-an opportunity to decisively incorporate public health, including public health systems, through the continuum of medical education. although medical educators have made progress in integrating public health content into medical curricula, "public health" is not a phrase that is consistently used in curricular standards, and public health colleagues are not identified as unique and essential partners to improve and protect health. the covid- crisis has demonstrated how a strong public health system is necessary to support the health of patients and populations, as well as the practice of medicine. partnerships between medical and public health communities, through individual-and population-based interventions, can also more effectively combat more common threats to health, such as chronic diseases, health inequities, and substance abuse. to achieve a more effective medicinepublic health relationship in practice, curricula across the continuum of medical education must include explanations of public health systems, the responsibilities of physicians to their local and state governmental public health agencies, and opportunities for collaboration. medical education should also prepare physicians to advocate for public health policies, programs, and funding in order to improve and protect the health of their patients and communities. pandemic covid- demonstrates with laser focus that all physicians are part of public health systems and that public health content has a distinct and critical place across the continuum of medical education to prepare physicians to participate in, collaborate with, and advocate for public health systems. "what we as a society do collectively to assure the conditions in which people can be healthy." in the wake of the september terrorist attacks and subsequent anthrax attacks of , the iom articulated a vision for stcentury public health systems that have governmental public health as the "backbone"; include the health sector (health care delivery system, public health, and health sciences academia); and broaden participation to include communities (e.g., schools, organizations, religious congregations), businesses and employers, and the media. medical educators have similarly emphasized the importance of community engagement and interprofessional education. we wholeheartedly support this holistic perspective of health education but ask that public health entities and professionals not be grouped into a broad category of "community partners." with shared primary missions to improve health, medicine and public health should be unique and consistent allies, working together with community partners to address society's health challenges. calls to enhance public health content in medical curricula typically increase after significant threats to public health. a physician workforce that is knowledgeable about public health can better anticipate and contribute to public health interventions during a pandemic. the emergency preparedness and response capabilities for governmental public health agencies have been described in categories: biosurveillance, community resilience, countermeasures and mitigation, incident management, information management, and surge management. at the time of crises, physicians contribute to surveillance efforts and echo public health messaging to patients from clinics and hospitals. collaborating in public health emergency initiatives may also offer insights and experiences that promote physician resilience during emergencies and help to meet the needs of their patients, practices, and communities. the medical and public health professions have not collaborated fully to meet health needs in the united states, in part due to differences in perspective and priorities. treatment versus prevention, "reductionist" biomedical models versus bio-social-environmental landscapes, pure science versus efforts to translate evidence into policies-these have been some of the generalizations that have described the differences between medicine and public health. cultivating meaningful partnerships between medical and public health communities to address more common threats to health through individual-and populationbased interventions would improve the prevention and management of chronic diseases, injuries, and substance abuse; strategies to catalyze improvements in social determinants of health and achieve health equity; and the formulation of health-focused approaches to address global challenges like climate change. to achieve more effective medicinepublic health relationships in practice, medical education across the continuum must include explanations of public health systems, the responsibilities of physicians to their local and state governmental public health agencies, and opportunities for collaboration. governing bodies that oversee each phase of medical education should ensure that public health systems are included in curricular requirements, beginning by building foundational knowledge in medical school, then exploring specialty-specific issues in residency and continuing education. with an enhanced appreciation of the relevance of public health to their practices, physicians are also more likely to seek out public healthrelated content-through informal channels and professional societies-and incorporate public health in their expectations of lifelong learning. while a full and systematic assessment of our preparedness and response to covid- will occur after this crisis, some conclusions are glaringly evident. delays in testing have resulted in missed surveillance opportunities through the timeline of the u.s. outbreak, and the coordination of the response capacity in hard-hit areas has fallen short. dangerous shortages of personal protective equipment have threatened the lives of health care and other essential workers. minority communities have been disproportionately impacted. public health agencies are frequent conveners of preparedness planning activities at local and state levels, when stakeholders identify and try to correct potential gaps in response capacities. unfortunately, u.s. public health systems remain dangerously underfunded and frequently operate without the recognition and stature of the health care system. in many regions of the country, the public health infrastructure needs to be expanded to achieve the kind of coordinated testing, robust case identification, contact tracing, and follow-up to provide clinical guidance and inform policy decisions, such as loosening restrictions on daily life. medical education should also prepare physicians to advocate for public health policies, programs, and infrastructure that will improve and protect the health of their patients and communities. advocacy has been incorporated into medical curricular standards, and credible physicians engender trust in science, even in the face of complex political environments. at a minimum, all physicians should be knowledgeable about policies that will affect the health of their patients, communities, and practices and consider them when they vote. governmental public health and health-related policy can be political, however, and some physicians may hesitate to become directly involved. at the turn of the st century, for example, physicians were less likely to vote than the general public. still, specialty societies are facilitating advocacy efforts, not only to promote specialty-specific interests but also to educate and inform policymakers and the public about a broader scope of issues that impact health. this is a teachable and learnable moment for medical learners across the curriculum to become better acquainted with public health. medical educators, who are already innovating and collaborating on delivering instruction virtually, are encouraged to integrate public health into their efforts. academic medicine readers may enjoy brandt and gardner's clear and succinct narrative of the relationship between medicine and public health in this country and frieden's description of the future of public health. for brief, introductory presentations on specific aspects of public health, the centers for disease control and prevention's e-learning series, public health , too often, the public health and clinical care systems and professionals operate in parallel rather than in synergy, but a key public health-related principle in flexner's report was that "collaborations between the academic medicine and public health communities result in benefits to both parties." the iom identified levels of physician engagement with public health: ( ) "all physicians," because practices intersect public health; ( ) physicians in practices or specialties with public health needs; and ( ) physicians specializing in public health. during this crisis, we have been reminded of what is "essential." we have witnessed that in addition to advising the public, workplaces, schools, and communities, public health plays a crucial role in health care delivery, providing data and giving guidance for infection control, testing, and clinical care in all settings, from laboratories to emergency medical services and home care. pandemic covid- provides all of us, whether we are on the frontlines of the response or are sidelined from our usual practice and finding ways to provide material and moral support to frontline colleagues, laser focus that "all physicians" are indeed part of public health systems and that the capacities of public health systems impact our patients, communities, and practices. widespread availability of public health content in medical education across the continuum can help facilitate solutions to daunting challenges like climate change, firearm injury prevention, health inequities that contributed to disparities in covid- morbidity and mortality, as well as pandemic preparedness, as we live and work in a global society. our collective challenge is to transform this teachable public health moment into a learnable moment for medical education. funding/support: none reported. other disclosures: j.k. carney receives royalties from a textbook, controversies in public health and health policy, jones and bartlett learning, . approach to public health: neglect, panic, repeat. the new york times the untilled field of public health medical education for a healthier population: reflections on the flexner report from a public health perspective training physicians for public health careers planning and incorporating public health preparedness into the medical curriculum public health emergency preparedness and response capabilities beyond disaster preparedness: building a resilience-oriented workforce for the future the impact of chronic underfunding of america's public health system: trends, risks, and recommendations perspective: physician advocacy: what is it and how do we do it antagonism and accommodation: interpreting the relationship between public health and medicine in the united states during the th century the future of public health national association of county and city health officials. the forces of change in america's local public health system association of state and territorial health officials. astho profile of state and territorial public health, volume four ethical approval: reported as not applicable. key: cord- -uiusqr authors: spil, ton a.m.; romijnders, vincent; sundaram, david; wickramasinghe, nilmini; kijl, björn title: are serious games too serious? diffusion of wearable technologies and the creation of a diffusion of serious games model date: - - journal: int j inf manage doi: . /j.ijinfomgt. . sha: doc_id: cord_uid: uiusqr today globally, more people die from chronic diseases than from war and terrorism. this is not due to aging alone but also because we lead unhealthy lifestyles with little or no exercise and typically consume food with poor nutritional content. this paper proffers the design science research method to create an artefact that can help people study the diffusion of serious games. the ultimate goal of the study is to create a serious game that can help people to improve their balance in physical exercise, nutrition and well-being. to do this, first we conducted interviews to study if wearables can be used for gathering health data. analysis indicates that designers, manufacturers, and developers of wearables and associated software and apps should make their devices reliable, relevant, and user friendly. to increase the diffusion, adoption, and habitual usage of wearables key issues such as privacy and security need to be addressed as well. then, we created a paper prototype and conducted a further interviews to validate the first prototype of the game, especially with respect to the diffusion possibilities of the game. results are positive from a formal technology acceptance point of view showing relevance and usefulness. but informally in the open questions some limitations also became visible. in particular, ease of use is extremely important for acceptance and calling it a game can in fact be an obstruction. moreover, the artefact should not be patronizing and age differences can also pose problems, hence the title not to make the serious game too serious. future research plans to address these problems in the next iteration while the future implementation plan seeks for big platforms or companies to diffuse the serious game. a key theoretical contribution of this research is the identification of habit as a potential dependent variable for the intention to use wearables and the development of a diffusion model for serious games. the hedonic perspective is added to the model as well as trust and perceived risks. this model ends the cycle of critical design with an improvement of theory as result contributing to the societal goal of decreasing obesities and diabetes. mobile health solutions, including those with the ability to provide healthcare delivery, advice and access to healthcare information, are rapidly gaining prominence (american diabetes association, ) . this is largely due to increases in computing power and developments with smart phone capabilities and technologies (global mobile statistics, ). there are many benefits of mobile health solutions; namely convenience, a low or negligible learning curve, and they are accessible essentially / (steinhubl, muse, & topol, ) ). mobile health technologies tend to support both health and wellness aspects across all age groups, genders and ethnicities and this makes them particularly popular especially with consumers (markoff, ) . hence, we are witnessing mobile solutions to support diet and exercise activities, management and empowerment for people with chronic conditions such as diabetes as well as mental wellness and behaviour support (global mobile statistics, ). the use of self-tracking wearable technology has increased in popularity and is now being used as a means of optimising the health, fitness, and well-being of individuals and even groups. the widespread diffusion and adoption of wearables requires the development of rich and robust lenses to conceptualise and understand the drivers of their success (benbunan-fich, ) . in this research, we define wearables as devices worn by individuals which monitor variables such as steps taken, heart rate, speed, pace, distance, calories burnt, hour slept, quality of sleep, and even dietary information. the sale of wearables is soaring and is set to grow by % in (https://techcrunch.com/ / / /wearable-spending-forecasted-to-increase- -in- /). million wearables were sold in worldwide and total sales are expected to grow to million in . while the diffusion of wearables is high the long term adoption of wearables and the apps on them is low. the rate of abandonment and usage of wearables and the apps on them respectively is substantial. hence there is a strong need to investigate the users of wearables and find out (a) what would help make wearables and the apps on them a 'success' and (b) why the adoption of wearables and the apps on them is a 'failure' so far. serious games is a term used to describe the development of games specifically designed to achieve some change in the player. this could be a change in knowledge, attitude, physical ability, cognitive ability, health, or mental wellbeing. mccallum identified three types of health games: games focussing on physical health, cognitive health and social and emotional health (mccallum, ) . as noted by hamari and keronen ( ) more and more games are increasingly being employed for a variety of purposes yet the literature is scattered and there is a lack of a clear and reliable understanding of why games are being used and what their benefits are. moreover, it is still to be established how they are placed with respect to the utilitarian-hedonic continuum of information systems (hamari & keronen, ) . further, they note that on reviewing studies they found that some believe that because games intended for instrumental use are rated high regarding enjoyment and usefulness games are thus multipurpose is which rely on hedonic factors and the pursuit of instrumental outcomes. this paper proffers the design science research method to create an artefact that can help people to improve their balance in physical exercise, nutrition and well-being. specifically, the wearable incorporates serious games to investigate the research question "how can we create a qualitative diffusion model for serious games?" this study will focus on the motivational purpose of serious games. the paper is structured as follows: in the following section we first look at adoption and diffusion literature and then focus on the diffusion of wearables and thereafter on the diffusion of serious games. in section we explain our research method and section discusses the interview results. section mirrors the literature review and discusses the interview results in terms of diffusion of wearables and the adoption of serious games. in section we discuss the the theoretical and practical implications of our study and results. section closes with conclusions. in this section we first present relevant aspects of the adoption and diffusion literature to create the basis for the interview model. this is followed by specific wearable diffusion issues from literature and finally we discuss the diffusion of serious games from a theoretical perspective. for the interviews we made use of the use it model (landeweerd, spil, ton, & klein, ) , a qualitative research model derived from the utaut model (venkatesh et al., ) , diffusion of innovation model (rogers, ) and the is success model from delone and mclean ( ) . fig. illustrates the use it model that integrates the four determinants of success of ict. the use it model makes a distinction between process and product of innovation as rogers ( ) does. the domains are taken from delone and mclean ( ) who show the net benefits of an information system in the user domain (relevance) and the information, system and service quality in the information technology domain. we used a grounded literature review using the approach of wolfswinkel, furtmueller, and wilderom ( ) . the key steps in the process are define, search, select, analyse and present. appendix illustrates the summarised metadata for this grounded literature review. the main dissatisfaction when using a wearable is not being able to fulfil the expectations of the users in terms of fit, comfort, form factor, selectability, adaptability, and overall utility (coorevits & coenen, ) . this could be due to the limited focus of designers and developers on the needs of the user. nascimento, oliveira, and tam ( ) revealed that satisfaction affected intention to continue to use in particular those who were not power users but had a low level of habit. consumers may actually 'have inflated expectations about the ability of wearables to change nutritional habits'. furthermore they mention that consumers may have specific needs such as diet needs that are not captured well nor displayed by the dashboards of wearables (canhoto & arp, ) . buchwald, urbach, and von entreß-fürsteneck ( ) speak about satisfaction as well as dissatisfaction as important metrics in understanding continuance and discontinuance of self tracking devices. they use the hygiene theory of herzberg, and suggest that while hygiene factors can cause dissatisfaction, they may not necessarily cause satisfaction. for example, the unreliability of the system creates and fosters an intention to discontinue, but its absence does not contribute to the formation of an intention to continue. 'experience with technology is a key parameter in consumers' adoption' (kalantari, , p. ). in the context of self-tracking technology, kari, koivunen, frank, makkonen, and moilanen ( ) found that critical experiences promote or hinder the adoption and thereby lead to rejection during the implementation. they also found that prior experiences on self-tracking technologies had an influence on the expectancy of performance of new technologies. in the context of post-adoption and sustained use, handson experience with the technology influences habit and use. and habit in turn influences behavioural intention and use behaviour (venkatesh, thong, & xu, ) . limayem, hirt, and cheung ( ) refers to habit as ''the extent to which people tend to perform behaviors (use is) automatically because of learning'' (p. ). they discuss four conditions that are likely to form is habits: ) frequent repetition ) extent of satisfaction with outcomes ) relatively stable contexts and ) comprehensiveness of usage of the is system. prior frequency of behaviour is important for the habit strength. rogers ( ) does not use the term habit but shows the importance of institutionalisation of a new innovation. while experience is necessary for forming a habit it is not in itself a sufficient condition (venkatesh et al., ) . wearables have specific characteristics; due to novelty of a technology habit could be an important factor in technology acceptance (polites & karahanna, ) . users seem to have problems keeping activity trackers on their person. they remove them to engage in activities such as showering, washing dishes, etc (shih, han, poole, rosson, & carroll, ) . there also seems to be a trade-off in terms of size of the wearable. smaller ones are easy to wear and carry but also easy to forget and more fragile while larger ones cannot be forgotten but they are also inconvenient to carry and bulky. however respondents did not seem to have problems remembering to carry car fig. . the use it model (spil, schuring, & michel-verkerke, ) . t.a.m. spil, et al. international journal of information management xxx (xxxx) xxxx keys, mobile phones, and wallets. shih et al. ( ) believe that with longer adoption periods wearables will become a part of their daily (activity) routines. individuals have to (a) prepare the wearable such as charging (b) make sure the gps is working (c) turn them on and (d) finally remember to bring it (lupton, pink, heyes labond, & sumartojo, ) . while some of these could become a part of a routine/habit there were other aspects that required constant attention and vigilance. fritz, huang, murphy, and zimmermann ( ) did a longitudinal study on fitness trackers using wearable devices in three different continents. the wearables became a part of them and they felt strange when they took it off. however most of them lost interest when the novelty wore off and the monitoring became routine. once they crossed the learning curve and were able to estimate their steps and/or calories without the device by themselves, the wearables became obsolete. research interests in serious games have increased over the last decade and we now find a few similar definitions of serious games in existing literature: "serious games are games that do not have entertainment, enjoyment or fun as their primary purpose" (michael & chen, ) . "serious games have an objective to use the entertaining quality of the game for training, education, health, public policy, and strategic communication objectives." the combination of these two definitions is maybe the best way of defining serious games. the purpose differs from entertainment oriented video games but this does not mean that it cannot be fun or joyful to play. in addition, marsh ( ) argues that not all videogame characteristics, such as challenge, fun and play, are appropriate descriptions or labels for all serious games. we define serious games as: "playful acts that do not have entertainment, enjoyment or fun as their primary purpose but have training, education, health, public policy, and strategic communication objectives". over the recent past gamification has increased in popularity (koivisto & hamari, ) . gamification refers to designing information systems to afford similar experiences and motivations as games do, and consequently, attempting to affect user behaviour (koivisto & hamari, ) . the authors reviewed studies and found that while the results in general lean towards positive findings about the effectiveness of gamification, the amount of mixed results is sufficient to urge caution (koivisto & hamari, ) . furthermore, education, health and crowdsourcing as well as points, badges and leaderboards persist as the most common contexts and ways of implementing gamification (koivisto & hamari, ) . taken together their findings suggest that there is much room to design more suitable serious games to support specific goals. this would also suggest that more incorporation of codesign and user centred design in gamification for healthcare could prove to be a critical success factor in the update and continued use of this games in this context. deterding, dixon, khaled, and nacke ( ) divide the world in a playing world and a non-playing context. in this paper we instead see an entertainment-oriented and a goal-oriented approach to game design. inbetween we see entertainment games that are partially used for real-life purposes and real-life games that become more fun. garris, ahlers, and driskell ( ) developed a game model in which they call the in-between group instructional games. they clearly describe a scale from video games to game-based learning and state that "there is little consensus on game features that support learning" (p. ). hamari et al. ( ) focus on the challenge and skill (flow) and engagement and immersion of perceived learning. they conclude that serious games must challenge and engage the players for better learning. kiili ( ) also focuses on flow. flow is seen as challenges versus capabilities of the player. an interesting aspect is that feedback is both part of the flow task as well as the flow artefact indicating that adding feedback to entertainment games can give a learning effect. transformational learning can be the bridge, communicating the power of games (barab et al., ) . furthermore, the positioning of the person and content are closely linked (sousa et al., ) , where positioning context can be derived from dialogues and narratives. most researchers focused their study on different purposes of serious games. there has been a lot of research in the effectiveness of serious games in teaching-learning related processes. for example, buchinger and hounsell ( ) reviewed a list of collaborative-competitive serious games in the teaching-learning process. they mentioned important design features: intra players interaction, synchronization, roles, resources, score, challenge, reward, artificial intelligence and operationalization. this study will focus on the motivational purpose of serious games to create consciousness and behaviour change. in the next section we introduce the adopted research method. in line with the set of principles for conducting critical research in information systems as discussed by myers and klein ( ) , our research consists of elements of critique as well as of transformation. we question the actual adoption and effectiveness of wearables and serious games -the principle of revealing and challenge prevailing beliefs and social practices -by making use of the it adoption model as discussed in the previous section based on insights from innovation and adoption researchers like davis, bagozzi, and warshaw ( ) , delone and mclean ( ) , rogers ( ) and venkatesh et al. ( ) -the principle of using core concepts from critical social theorists. we study how the adoption of serious wearable games can be improved -the principle of taking a value position -in order to help improve health on both an individual and societal level -the principles of individual emancipation and improvements in society -and try to improve diffusion models for serious games by identifying habit as a potential dependent variable for the intention to use wearables -the principle of improvements in social theories. we use elements of critique (myers & klein, ) such as the principle of using core concepts from critical social theorists dating back to ajzen and fishbein ( ) and bandura ( ) leading toward the theory of planned behavior. the emphasis on relevance in the interview method used leads to a value position critical theorists advocate. finally the principle of revealing and challenging prevailing beliefs and social practices is well established in this paper by choosing a society problem (obesities and diabetes) and explore behavioral change with help of wearables and serious games. the element of transformation (myers & klein, ) are also studied in this paper. the principle of individual emancipation is studied with efficacy (bandura, ) which is used in the utaut model (venkatesh, ) . this study is aimed at health improvements in society and provides a theory improvement with a new model for diffusion of serious games. for attaining these research goals, a mixed method approach was adopted. in order to design our mobile health serious game, we made use of an adapted version of the design science research method (dsrm) process model, as based on the work of peffers et al. ( ) . after performing the literature study, we conducted semi-structured interviews with actual owners and users of wearables. the initial group of interviewees was very diverse with users of different ages, backgrounds and education levels. in order to make the results more generalizable and the interview sample more homogenous we made use of the so-called drilldown technique. this was accomplished by focusing on interviewees that can be regarded as the most active users, i.e. millennials (between and years old) who are far more likely to own wearables than older adults and who use wrist-worn wearables for general health and fitness purposes. in order to focus our analysis on a homogeneous group of early adopters (rogers, ; yin, ) , we developed a subset of interviews which where analysed in-depth. the majority of the interviewees (a) were highly educated (b) had experience with technology in general and ict in particular and (c) were willing to voluntarily adopt new technologies such as wearables. the other interviews were used for the requirements of the wearables and the serious game for diabetes and obesities. we analysed the qualitative interview data by doing a sentiment analysis through coding (huberman & miles, ) . we divided our analysis into three different phases: data reduction, data display and drawing conclusions/verification. after getting a better insight in the adoption of wearables based on a sentiment analysis, we designed a specific game artefact based upon interviews with potential users in a wide age scale and demonstrated the artefact in a student environment during a week testing period. before doing a second iteration, we conducted another interviews to validate the first prototype of the game, especially on diffusion possibilities of the game. our study can be regarded in sum as a qualitative study of diffusion of wearables and serious games; we did not focus on the specifics of the serious game itself (i.e. its user intertface). this following section describes the objective descriptive data as given by the interviewees. this is followed in the subsequent section by a sentiment analysis and comparison to literature. around % of the interviewees had a smartwatch and 'apple' was the most mentioned brand. around % possessed some form of bracelet. pedometers, sportwatches, pebble and fitbit made up the rest. the primary purpose of using wearables seems to be for the monitoring of steps and heart rate (fig. ) . four out of seven respondents use the heartrate function for sport/movement, whereas running is the most mentioned sport. analysis of sleep was mentioned by three interviewees, of whom two were interested in the amount of sleep while the third was interested in the rhythm of sleep. nearly twenty five percent of the interviewees mentioned that they would like to have an extension of their smartphone as part of their wearable. two interviewees mentioned that they want to have a standalone device having its own internet access and own gps. two mentioned that they would like to be able to monitor blood pressure. the following items were mentioned as extra features that users would like to have: bmi, weight, scanning food instead of filling it in, body temperature, health app giving prescriptive advice about certain disease/disorder, monitoring health in order to change behavior, and amount of alcohol in the blood. a fitbit user also mentioned wanting to have more functionality with regards to movement. essentially there was consensus that wearables needed to be more comprehensive and standalone. when queried on the crucial factors for the use of wearables nearly twenty five percent of the interviewees identified additional value and ease of use as being important (fig. ) . twenty percent of the respond mentioned reliable data and personal interest either in new technology or from a hobby point of view. lifespan of battery was of importance to fifteen percent. only ten percent mentioned health, communication, behaviour change and stand-alone device as being important. the adoption of serious games is predicated on a number of factors as illustrated in fig. below. although the structured analysis is very positive, showing a high probability of diffusion, the emotional analysis shows some limitations that the next design must overcome. the emotional analysis is given in quotes: • "i wonder why it cannot be a normal app and has to be a game" • "i think it looks a bit childish" • "i do not want the game to treat me like a child" • "i already know that i need to exercise more" • "cheating is easy" the analysis shows that the next iteration should take care of age differences and preferences and the interaction with the game should be as easy as possible. we should reconsider to call it a game or an app. in fig. only the key areas are mentioned. just like in most of the tam (technology acceptance model) studies perceived usefulness is important and in this case % of the interviewees says that staying healthy is very relevant and if the game contributes to that they would use the game. ease of use is on the same level ( %) but is relatively more important because so many interviewees mentioned it more than once. only % of the interviewees was concerned with privacy. % of the interviewees mentioned measuring and using physical activity in the game would be good and easy to accomplish. on nutrition and relaxation they were not that sure both in measuring and using it. the research question under consideration was "how can we create a qualitative diffusion model for serious games?" to answer this research question we did a systematic literature review that provided us with the confirmation of relevance as the most important determinant of diffusion of both wearables and serious games. what is unique and interesting about our research findings includes the notion of habit as a new determinant for the diffusion of serious games. the institutionalisation of the serious game is an important factor to make the serious game a lasting success. the dynamics of the game will improve the flow and will prevent the treatment to become boring. the first study on wearables confirmed the importance of the habit determinant and in table we build a new proposition for serious games. next to that we propose perceived enjoyment as determinant for successful diffusion of serious games. finally we use the concept of information quality of delone and mclean to address the importance of learning and feedback in serious games. moreover our findings contribute to both theory and practice as follows. diffusion of wearables is hindered by the perception of a lack of relevance by users and a lack of relative advantage. there is the potential to add new features and / or functionalities to these wearables such as blood pressure, temperature, and even sugar level measurement in the future. this may enhance the perception of relevance. however, the more information is captured the more security and privacy issues arise. currently wearables just provide descriptive facts. yet, in the opinion of the authors, for wearables to be really effective, they need to go beyond descriptive information and provide prescriptive information that will allow users/wearers to take action. from a serious gaming point of view, we can conclude that staying healthy is the most relevant factor and the perceived usefulness should address this for the user to adopt this serious game. the main idea from the interviews and first design cycle is to "improve health by having fun". the fun element is not elaborated yet because we think this is more the domain of professional game designers than e-health researchers. still fun or enjoyment is of major importance for the game. the new diffusion model for serious games can help researchers to study if a specific serious game is likely to diffuse in the target group. in section . is shown how this can be done in practice. one of the key factors for discontinuing the use of wearables is the presence of errors and lack of reliability. while organizations can depend on it-service departments and/or external contractors to solve bugs, errors and reliability issues, this is not the case for personal/individual ict such as wearables. it is expected that personal icts are accurate and reliable and it is left to the individual to solve problems but unfortunately most individuals do not have the knowledge, will, or time to troubleshoot and solve problems and issues that may arise with personal ict. overall, the results indicated that people were neutral to positive with regards to sharing information, body data, habits, addictions, and the living environment that the wearable provided for diagnosis and statistical research. the extent to which they are willing to share their data depended on several factors. while people believe wearables can be hacked, their opinion is divided with regards to their privacy being at stake. from a monitoring point of view, nutrition is the hardest factor to measure. it is subjective and cannot be done in an automated way. suggestions from the literature and interviews are to use speech recognition and imaging to monitor as easy as possible. when analysing the outcomes of the interviews, the specific reasons for why some people do not adopt or habitually use the wearable, is not very clear. however, what became clear was that users of simple, unsophisticated models did not develop the habit of using wearables every day nor throughout the day. in conclusion, from the literature and from the validation of the game design, one thing is very clear: the game (if we call it a game) should be simple and "stupid". the ease of use is mentioned throughout all interviews and is clearly warned for in literature as shown in the background section. hence the title not making the serious game too serious and limit the amount of feedback. serious games increasingly blur the boundary between hedonic and utilitarian information systems (berfine koese, morschheuser, & hamari, ) . in and of itself this may not be an issue but it does mean that users may perceive the purpose of the same system differently, ranging from pure utility to pure play (berfine koese et al., ) . this could help explain why some of the serious games in healthcare are not so successful on a larger scale as initially expected. further, it may indicate that ensuring a more consistent understanding of the purpose of the game amongst users could be significant in improving the success of the specific game with regard to its particular healthcare benefit. from games reviewed by the authors, not all of which were healthcare focused (berfine koese et al., ) , they found that the more fun-oriented users perceived the system to be, the more enjoyment affects continued and discontinued use intentions, and the less ease of use affects the continued use intention (berfine koese et al., ) ; hence, users' conceptions of the system are an important influential aspect of system use and should particularly be considered when designing modern multi-purposed gamified information systems which have a specific purpose or focus such as in healthcare contexts. our study confirms that these user conceptions from the emotional analyses seems troublesome although from a quantitative analysis there seem to be no problems for diffusion. it is therefore important to take a qualitative perspective. our paper has also served to contribute to developing further the application of dsrm into healthcare contexts, in particular we have incorporated aspects around privacy/security which are essential considerations when designing healthcare related solutions. in table they are shown as trust and perceived risks. we have also included a consideration for hedonic aspects; i.e. perceived enjoyment (van der heijden, ) with the game while still subscribing to its utilitarian goal of supporting a critical healthcare need. we note that to date these two aspects -privacy/security and hedonic aspects -have not been incorporated into dsrm. for example while brooks and el-gayar et al. ( ) adopted a dsrm approach to examine the implementation of electronic health records neither these two elements were part of their consideration. we suggest that due consideration to privacy/security and hedonic aspects are useful to incorporate as shown in table and appendix and thereby extend dsrm when applied in healthcare contexts but probably also in other contexts. the extensive and critical use of the dsrm method in this paper justifies a generalisation of the findings in both the diffusion of wearables and the future diffusion of a serious game for diabetes and obesities which is the ultimate goal of this study. hence our research results serve to build a new theoretical model that can be used to predict whether a serious game will diffuse in society and start to reach behavioural and motivational objectives. we use kalantari's ( ) perspective to study wearable technologies. table shows the comparison and analysis of both interview studies. it is followed by building a new model for diffusion of serious games specifically. finally we can build upon this analysis to develop a new model for qualitative design science studies of the diffusion of serious games. from theory (section . ) we derive the horizontal axis with fun, feedback and flow. next to perceived usefulness (davis et al., ) we table the success factors analysed with the use it construct. success factors expected to be measured process perceived compatibility all interviewees have either a smart watch, sports watch, fitbit or pedometer. all interviewees have internet online. all interviewees use a digital device on which an app can function. all interviewees have internet online. perceived usefulness perceived usability sport is at the top. this is closely followed by health. staying healthy is the most relevant subject that the interviewees mention in % of the interviews. relevance or additional value is a big theme and mentioned by % of respondents. ease of use is mentioned in more than % to be important for the success of the game. information quality among younger people, the primary appeal is fitness optimization. older people are seeking to enhance their health and wellbeing and also to extend their life. measuring physical activity is the most mentioned functionality that already % of the interviewees do. they want it to be easier and the other % expects to use it if provided. most respondents were positive with respect to their enhanced insight and ability to monitor their health indicators. however they were divided regarding the enhancement of their personal health because of wearables. measuring nutrition is seen as difficult and only useful if it can be done in an easy way. measuring sleep and stress was done by just a few of the interviewees and is a topic that needs further study. service quality system quality perceived risks privacy and security on wearables does not appear to be a serious concern for the developers of the wearables and the apps on them nor for the users of the wearables and apps. most interviewees think they are going to use the game when it improves their health. only % see privacy risks. trust social and personal influence reliability is a big theme which was mentioned by almost % of the respondents. nearly all interviewees state that they want to spend some time for using the serious game. however a minor theme concerns the willingness of people to provide health data. they think it is more a personal tool for their personal use than a healthcare system tool. many interviewees state that peer pressure might help them to stay on track with their health objectives. t.a.m. spil, et al. international journal of information management xxx (xxxx) xxxx add the hedonic perceived enjoyment (van der heijden, ) . from section . we add the determinant habit. this determinant is specific for innovations that have to be used many times and should be validated in a future quantitative study in an extended tam or utaut. a proposition would be: habit has a positive and significant impact on user intention to use a serious game in healthcare. for requirements we did not use new notions but used the is success model of delone and mclean ( ) and the tam model (davis et al., ) . we determined an overlap between resources and resistance and took these elements together and renamed it reliability. trust and perceived risks were already added in the use it model (landeweerd et al., ) . it can be a relevant addition to the utaut model, yu ( ) labelled it perceived credibility. the results in this table should not be compared with evaluation studies of serious games where learning and behaviour play an important role (petri & gresse von wangenheim, ) , the table is focused on diffusion of serious games in a qualitative way. in appendix we elaborate the content of this model toward interview questions. we start the interview with process questions to check the compatibility (rogers, ) of the new serious game and to get to know the interviewee. the interview model in appendix addresses all factors found in table above. this interview model can be used by practitioners who want to develop a new serious game in healthcare environments. the interview will take approximately one hour and the amount of interviews will depend on the variety of the user (player) group. for each homogeneous group at least one interview should be done but preferably two or more. serious games have evolved from being 'games' to just being 'serious'. they have become so serious that they are devoid of fun. this has had a significant impact on the adoption and use of serious games. to address this problem we have proposed a model for the adoption of serious games whose central tenets are fun, feedback, and flow. equally important are three more elements of the model namely: relevance, reliability, and fulfilments of requirements. these six elements together will enhance enjoyment, usefulness, trust, quality, and ultimately lead to the diffusion and adoption of serious games. but the most important outcome that the model hopes to achieve is the design of serious games that will lead to the transformation of individuals, reduction of bad habits and instilling of good habits. when we consider the various stakeholders in this space it becomes quite clear that at the heart of it is/should be the customer, namely the end users of the serious game (fig. ) . influencing the end user and being influenced by the end users are the game development studios, designers of serious games, and researchers of serious games. we also recognise the mutually reinforcing roles of all stakeholders (sein et al., ) and the reciprocal shaping of both the artefact as well as the stakeholders. the practical implications of our research apply to all four stakeholders. what we have witnessed in the covid- pandemic has underscored more than ever the importance of health and wellness but mostly about keeping healthy. moreover, it has shown that individuals need to take more responsibility in monitoring and managing their health and wellness supported by mobile and wearable technology aids. currently there are over , apps to support and assist patients with diabetes, however all these solutions have poor uptake and even less sustained use (jimenez, lum, & car, ) . a key reason for this is around the engagement of the user and the ability of the solution to sustain behaviour change. gamification has been shown to assist with increasing user engagement and sustained usage but incorporating aspects of gamification for health and wellbeing is still in its infancy (johnson et al., ; spil, sunyaev, thiebes, & van baalen, ) . our study has served to highlight critical aspects that need to be considered when designing the specific serious game that focus specifically on the reliability of the game, its requirements and relevance combined with ensuring the solution is fun, provides the correct level of feedback and the flow is appropriate. educating the users regarding the purpose of the game seems to be crucial in the success of the game in terms of health benefits. obviously ease of use perceptions of usefulness are also critical in adoption of the games. thus, our developed model provides a suitable rubric for game designers so that they can develop wearable and mobile solutions to address a specific health or wellness aspect with confidence, knowing it will have a high likelihood of uptake and sustained use. from the perspective of practice of equal importance is the business or financial angle, since the cost of designing and developing games which have poor uptake and even poorer sustained use are not financially viable for developers and companies and do not help to address escalating healthcare costs either. the diffusion, adoption, and retention of serious games by end users is of great concern to the game development studios. working together with all stakeholders, leading to the transformation of individuals, families, and communities should be their primary goal and vision. depending on the health system the studios need to work collaboratively with insurance companies as well as the health sector (public and private) to reduce the cost of health, improving health and wellbeing outcomes, and enhancing their enjoyment. considering the security and privacy concerns involved, a key challenge for the studios is to gain the trust of the stakeholders and in particular the end users and sponsoring or funding agencies such as the government and health sector. finally the artefacts we have created as part of this research: the prototypes, the models, and the instruments themselves can become the foundation for future research by other researchers of serious games. these were enumerated in section . above. finally, we want to stress that designing a serious game is not the holy grail for making the world healthy. staying healthy is multifaceted in many ways and only a game is not going to solve the many health related problems ahead. in combination with many other initiatives, it can help though to make the world a little bit better. moreover, to make wearable devices more relevant, more reliable and easier to use the adoption of serious games is beneficial. a limitation of this paper is that the study is done in a well developed country and although the authors are confident the model can be used in less developed countries, this has not been tested. a first validation of the interview framework is done with interviews and a specific prototype of a serious game on obesities and diabetes. future study is needed to for validating use for a serious game in general and also for using serious games in underdeloped countries. the identification of habit as a potential dependent variable for the intention to use wearables and the development of a diffusion model for serious games based on this insight can be seen as the most important theoretical contributions of our research. more specific, we found during our interviews and validation design cycle that serious health games should "improve health by having fun". this aspect seems to be a critical design issue and therefore we proposed to include hedonic aspects, like perceived enjoyment, next to privacy/security related aspects into the diffusion model for serious games, the artefact made in this design science research method. we think that focusing on these aspects when developing a health related serious game may improve its diffusion and as a consequence may help to improve health on both an individual and societal level as well. our research question was: how can we create a qualitative diffusion model for serious games? with the critical elements found in the section above we created a new diffusion model for serious games and tested it with interviews. we are confident that this model can improve diffusion of serious games in healthcare and hope it will be applied in many successful future 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utaut model key: cord- -fn bnnb authors: suyin chalmin-pui, lauriane; roe, jenny; griffiths, alistair; smyth, nina; heaton, timothy; clayden, andy; cameron, ross title: “it made me feel brighter in myself”- the health and well-being impacts of a residential front garden horticultural intervention date: - - journal: landsc urban plan doi: . /j.landurbplan. . sha: doc_id: cord_uid: fn bnnb residential gardens make up % of urban space in the uk, yet unlike many other green space typologies, their role in the health and well-being agenda has largely been overlooked. a horticultural intervention introduced ornamental plants to previously bare front gardens (≈ m( )) within an economically deprived region of north england, uk. measures of perceived stress and diurnal cortisol profiles (as an indicator of health status) were taken pre- and post-intervention (over months). residents reported significant decreases in perceived stress post-intervention. this finding was aligned with a higher proportion of ‘healthy’ diurnal cortisol patterns post-intervention, suggesting better health status in those individuals. all residents derived one or more reported socio-cultural benefits as a result of the front garden plantings, although overall scores for subjective well-being did not increase to a significant level. further qualitative data suggested that the gardens were valued for enhancing relaxation, increasing positive emotions, motivation, and pride of place. the results indicate that adding even small quantities of ornamental plants to front gardens within deprived urban communities had a positive effect on an individual’s stress regulation and some, but not all, aspects of subjective well-being. the research highlights the importance of residential front gardens to human health and well-being, and thus their contribution to the wider debates around city densification, natural capital and urban planning. an increasing body of research demonstrates that urban green space (ugs) has therapeutic value by allowing city dwellers to relax and engage with nature (frumkin et al., ; hartig, mitchell, de vries, & frumkin, ) . especially in urbanised societies, exposure to green space has been shown to generate positive benefits in emotional well-being addin csl_citation {"citationitems":[{"id":"item- ″,"itemdata": {"doi":"https://doi.org// . / . . ″,"issn":" ″,"abstract":"a growing body of empirical research suggests that brief contact with natural environments improves emotional well-being. the current study synthesizes this body of research using meta-analytic techniques and assesses the mean effect size of exposure to natural environments on both positive and negative affect. thirty-two studies with a total of participants were included. across these studies, exposure to natural environments was associated with a moderate increase in positive affect and a smaller, yet consistent, decrease in negative affect relative to comparison conditions. significant heterogeneity was found for the effect of nature on positive affect, and type of emotion assessment, type of exposure to nature, location of study, and mean age of sample were found to moderate this effect. the implications of these findings for existing theory and research are discussed, with particular emphasis placed on potential avenues for fruitful future research examining the effects of nature on well-being.","author": [{"dropping-particle":"","family":"mcmahan","given":"ethan a.","nondropping-particle":"","parse-names":false,"suffix":""},{"dropping-particle":"","family":"estes","given":"david","non-dropping-particle":"","parsenames":false,"suffix":""}],"container-title":"journal of positive psychology","id":"item- ″,"issue":" ″,"issued":{"date-parts": [[" ″]]},"page":" - ″,"publisher":"routledge","title":"the effect of contact with natural environments on positive and negative affect: a metaanalysis","type":"article-journal","volume":" ″},"uris":["http://www. mendeley.com/documents/?uuid = c e f - - b c-b ab- cdddf ″]},{"id":"item- ″,"itemdata":{"doi":"https://doi.org// . /eco. . ″,"abstract":"research indicates that contact with nature elevates positive emotions; however, relatively less work examines the mechanisms responsible for these effects. the present study experimentally tested whether a brief experience in nature promotes specific positive emotions, such as happiness, joy, and feelings of awe because of feeling absorbed and fully involved in its natural features. participants (n = ) were randomly assigned to either sit in a natural environment (i.e., a local arboretum) or a built environment (e.g., an outdoor stadium) for min while focusing their attention on their surroundings, and afterward rated their current feelings. results from structural equation modeling analyses indicated an excellent fit for a mediation model in which experience in a natural environment, as opposed to a built setting, significantly enhanced feelings of awe and other positive emotions, χ ( ) = . , p = . , cfi = . , rmsea = . , % ci (< . , . ). moreover, absorption emerged as a significant mediator of nature's impact on positive emotions. there was a particularly strong effect on feelings of awe ( % of variance explained by the full model). results indicate that nature fosters awe and other positive emotions when people feel captivated and engrossed in their surroundings. the present study extends research on nature's positive emotional benefits and provides implications for nature-based interventions, specifically on the significance of having absorbing experiences in nature. key words: contact with nature-natural environment-positive emotions-awe-absorption. (psycinfo database record (c) apa, all rights reserved)","author":[{"dropping-particle":"","family":"ballew ","given":"matthew t.","non-dropping-particle":"","parse-names":false," suffix":""},{"dropping-particle":"","family":"omoto","given":"allen m.","non-dropping-particle":"","parse-names":false,"suffix":""}],"containertitle":"ecopsychology","id":"item- ″,"issue":" ″,"issued":{"date-parts": [[" ″]]},"page":" - ″,"title":"absorption: how nature experiences promote awe and other positive emotions","type":"article-journal","volume":" ″},"uris":["http://www.mendeley.com/documents/?uuid= b f e - f- -ab e- d f b"]},{"id":"item- ″,"itemdata": {"isbn":" ″,"abstract":"perception and categorization -the prediction of perference -variations: group differences -a wilderness laboratory -nearby nature -the restorative environment -the monster at the end of the book -overview of preference research methodology -preference studies -outdoor challenge program -benefits and satisfaction studies.","author":[{"dropping-particle":"","family":"kaplan","given":"rachel","non-dropping-particle":"","parse-names":false,"suffix":""}, {"dropping-particle":"","family":"kaplan","given":"stephen","non-dropping-particle":"","parse-names":false,"suffix":""}],"id":"item- ″,"issued": {"date-parts": [[" ″] ]},"number-of-pages":" ″,"publisher":"cambridge university press","title":"the experience of nature: a psychological perspective","type":"book"},"uris":["http://www.mendeley.com/ documents/?uuid= a d - - a - cbb- eff c e a ″]}, {"id":"item- ″,"itemdata":{"doi":"https://doi.org// . / . . ″,"abstract":"the physical and social participatory properties of landscapes have been explored using affordance theory but, as yet, the affective dimension of affordances is ill-defined. this paper sets out a framework for integrating affect within the affordance perceptual model. in doing so, it draws on two established models of emotion that identify 'valence' (pleasure-displeasure) and 'arousal' (inactive-active) as basic dimensions underlying an emotional response. ethnographic methods were employed over a six-month period to observe the emotional responses to a forest setting in boys (aged - ) with extreme behaviour problems and confined to a specialist residential school in central scotland. over time, changes in affective responses to the setting were mapped and located both within the physical setting and within the circumplex emotion model. results show an increase in positive affective responses to the forest setting over time, accompanied by increased trust, exploratory activity and social cohesion, dimensions linked in the literature with well-being. the significance of this paper is two-fold: first, it extends research in restorative health by showing how forest settings can, in a rehabilitation context over time, offer opportunities for long-term 'instoration' in boys suffering from extreme mental trauma. second, it is a first attempt at integrating affect within the affordance perception framework providing a conceptual model which can be expanded upon by future researchers.","author":[{"droppingparticle":"","family":"roe","given":"jenny j.","non-dropping-particle":"","parse-names":false,"suffix":""},{"dropping-particle":"","family":"aspinall","given":"peter","non-dropping-particle":"","parse-names":false,"suffix":""}],"container-title":"landscape research","id":"item- ″,"issue":" ″,"issued":{"date-parts":[[" ″]]},"page":" - ″,"title":"the emotional affordances of forest settings: an investigation in boys with extreme behavioural problems","type":"article-journal","volume":" ″},"uris":["http://www.mendeley.com/documents/?uuid= de aeba-a - c- e- f dbea e"]}],"mendeley": {"formattedcitation":" (ballew & omoto, ; kaplan & kaplan, ; mcmahan & estes, ; roe & aspinall, )","plaintextformattedcitation":" (ballew & omoto, ; kaplan & kaplan, ; mcmahan & estes, ; roe & aspinall, ) ","previouslyformattedcitation":" (ballew & omoto, ; kaplan & kaplan, ; mcmahan & estes, ; roe & aspinall, )"},"properties":{"noteindex": },"schema":"https://github.com/citation-stylelanguage/schema/raw/master/csl-citation.json"} (ballew & omoto, ; roe & aspinall, ) , cognitive functioning , behaviour (guéguen & stefan, ) and physiological responses, including heart rate variability, pulse rate, blood pressure, skin conductance, cortical brain activity and diurnalcortisol profiles (haluza, schönbauer, & cervinka, ; neale,aspinall, roe, tilley, mavros, cinderby, coyne, thin, & ward thompson, ; roe et al., roe et al., , toda, den, hasegawa-ohira, & morimoto., ) . exposure to green space/nature has been linked to enhancement of the immune system (hansen, jones, & tocchini, ) and encouraging physical activity (cameron & hitchmough, ; de vries, ) . despite policy-makers having a growing understanding of the value of ugs from a health and well-being perspective, challenges remain as to where and what type of ugs should be incorporated into city planning. previous research implies that factors including scale, accessibility, quality, biodiversity and activity within ugs influence the relative health benefits (dallimer et al., ; fischer et al., ; keeler et al., ; wood et al., ) . several reports suggest that larger (mitchell, astell-burt, & richardson, ) , more naturalistic landscapes (stott, soga, inger, & gaston, ) with greater biodiversity (cameron, brindley, mears, mcewan, ferguson, sheffield, jorgensen, riley, goodrick, ballard, & richardson, ) promote more positive health effects. this might suggest that planners should prioritise larger, more informal parks or nature reserves over other forms of ugs, when considering 'therapeutic' or health-promoting landscapes (cameron et al., ) . yet recent epidemiological studies also indicate health indices improve when homeowners possess a garden (brindley, jorgensen, & maheswaran, ; dennis & james, ) . this implies that smaller, more intimate and readily accessible green space may also have a role in promoting health for urban citizens, and provide an alternative strategy to providing therapeutic space within the urban matrix. surprisingly, the value of residential gardens (also known as 'domestic', 'private' or 'home' gardens) as a health intervention has largely been overlooked (cameron, blanusa, taylor, salisbury, halstead, henricot, & thompson, ) . in a review of ugs and mental health, only approximately % of studies involved residential gardens (wendelboe-nelson, kelly, kennedy, & cherrie, ) and more information is required on the merits of this landscape type. moreover, in the context of ever-increasing urbanisation and city densification, there is evidence that some city planners see residential gardens as a dispensable luxury (haaland & konijnendijk van den bosch, ) . residential garden size is getting smaller, and some planners/developers are omitting gardens in new housing schemes completely (tahvonen & airaksinen, ). yet this may be folly if such features are enhancing human health and well-being. moreover, residential gardening is a common pastime with % of uk adults (department for culture media and sport, ) and % of usa homeowners taking part in regular garden activities (clayton, ) . thus, gardening holds much promise as an intervention for health and well-being. indeed, the value of private residential gardens as therapeutic landscapes was brought to the fore during the covid- virus outbreak (sofo & sofo, ) , where residents were socially isolated and the only green space that could be accessed for long periods of time, were private gardens (for those that possessed them). despite the dominance of residential gardening as an activity, much of the literature on gardening with respect to health and well-being actually relates to communal gardening on public or semi-public land, possibly because this is easier for researchers to access. communal gardening covers community garden schemes, allotments, hospices, prison gardens and horticultural therapy interventions. although the data is still not extensive, there is a greater evidence-base for benefits associated with communal gardening. these include improvements in: physiological relaxation (hassan, qibing, & tao, ) , stress relief (genter, roberts, richardson, & sheaff, ) , mental health (soga, gaston, & yamaura, b) , mood (grahn & stigsdotter, ) , social skills (himmelheber, mozolic, & lawrence, ) , self-esteem (cammack, waliczek, & zajicek, ) , confidence (eum & kim, ) , creativity (exner & schützenberger, ) , diet (hale et al., ) , and opportunity for physical exercise (soga et al., a) . although it would be logical to assume that benefits associated with communal gardening translate across to residential gardening (cervinka et al., ) , this needs testing, not least as a number of reports suggest that much of the benefits of communal gardening relate to social interactions, encouragement from peers and pride in producing produce. aspects that perhaps, may not be so relevant to private residential gardening, although residential gardens that are overlooked and enjoyed by neighbours or passers-by may have their own distinct socio-cultural influences. the research presented here aims to address the gaps in knowledge relating to private residential gardens and to help inform policy-makers and planners about their potential value in terms of well-being and socio-cultural relations. this is important because not only are gardens being omitted in some new developments, but existing gardens are also changing in terms of their land cover, with many being paved over to facilitate 'off-road' car parking or ease maintenance (chalmin-pui, griffiths, roe, & cameron, ) . in the uk, % of households have gardens (davies et al., ) equating to , km or % of the total urban area (office for national statistics, ), yet recent studies suggest as much as % of this area is now hard-surfaced, with some 'gardens' having no plants at all (bonham, ) . in reality, there is little understanding of how garden design, as well as type and extent of vegetation influences well-being (lin et al., ) . our research specifically focused on small, residential front gardens associated with high-density housing stock as these are the ones most frequently paved over. it looked to investigate the effects of introducing ornamental landscape plants to paved front gardens and then determining effects on the residents' health and well-being. ornamental plants were used exclusively, i.e. food crops were avoided, to ensure impacts related to aesthetics (haviland-jones, rosario, wilson, & mcguire, ) rather than additional material benefits, such as enhanced nutritional value or financial savings associated with growing the plants. previous research has shown that there is a positive relationship between aesthetic preference and well-being (hoyle et al., a (hoyle et al., , b . as the intervention was in front gardens, i.e. adjacent to the public streetscape, we were keen to determine if any wider socio-cultural benefits might accrue too, for example, any influence on neighbours. the research examined diurnal profiles of the hormone cortisol, within the residents who took part. the physiological stress response in humans is regulated by the hypothalamic-pituitaryadrenal (hpa) axis and its synthesis of cortisol (ryan et al., ) . the circadian cortisol pattern in healthy individuals is typified by a rapid rise in cortisol production on waking in the morning, a steady decrease until mid-day, followed by a progressively slower decline until evening; with levels reaching their lowest point just prior to an individual falling asleep at night. variations in this pattern can indicate hpa dysfunction, a consequence of a wide range of mental and physical health problems (adam et al., ) ; for example, less rapid declines may suggest prolonged fatigue or exhaustion caused by chronic stress (roe et al., ) . monitoring these diurnal profiles is important as simply calculating daily averages can be misleading -thus, for example, the assumption that high mean levels of cortisol correlate to enhanced stress and conversely low levels relate to stress-free conditions is an oversimplification (smyth, hucklebridge, thorn, evans, & clow, ) . we compared residents' cortisol diurnal profiles (i.e. the decline phase of the circadian pattern) here, in an attempt to determine if the garden intervention influenced physiological responses. healthier cortisol patterns have been cited previously for those living in areas with higher levels of green space (gidlow, randall, gillman, smith, & jones, ; roe et al., ; ward thompson et al., ) and for participants exposed to a forest setting compared to an urban one (lee et al., ) . based on the above evidence the research examined the following key questions will a front garden horticultural intervention -introducing plants to paved front gardens overtime ( months) affect residents by: q reducing perceived stress? q improving diurnal cortisol profiles, suggesting better hpa function/health status? q improving subjective well-being? q increasing physical activity? q improving connectedness to nature? q providing socio-cultural benefits such as enhanced community cohesion? a front garden intervention was carried out in an economically deprived region of north england, uk with plants and planted containers being introduced to resident's properties. pre-and post-wellbeing measures (subjective well-being, perceived stress, diurnal cortisol) were captured over a -week data collection period prior to and for at least months after each intervention, with the experiment being repeated over a two-year period, using two sub-populations of residents (i.e. groups a and b, fig. ). residents within group a were provided with plants and containers first (may ), with group b acting as a control (i.e. a comparator group without plants/containers) over the subsequent summer and autumn. residents within group b received their intervention the following year (may ). both groups were assessed on outcome measures pre-and post-the horticultural intervention (fig. ) . the experimental design followed reichardt ( ) "principle of parallelism" which recommends making multiple comparisons between groups over time (mark & reichardt, ). the quasi-experimental approach in a real-world setting acknowledged the lack of control over certain extraneous variables, including the lack of completely randomised groups (all residents showed some appetite to have a re-vegetated front garden). the experiment was conducted in salford, greater manchester, uk (grid reference sj ). salford was chosen due to an abundance of th-century terrace houses, with small ( m ) paved-over (non-vegetated) front gardens. the local housing association aided recruitment, with residents informed about the intervention via door to door leaflet dropping followed up via in-person door to door calls. residents who participated were all selected from the same neighbourhood (within km of each other), but divided into the two groups based on the street they lived in. thus group a (n = ) was selected and pooled from streets, and group b (n = ) derived and pooled from different streets. this provided geographic separation between the two groups to avoid either group influencing the other. there was no geographic or obvious socio-economic bias associated with the group distributions, with all residents within socio-economic classes - in the national statistics socio-economic classification (i.e. employment status that varies from semi-routine work to long-term unemployed), and the neighbourhood ranked as within the % most deprived in the uk (rose & pevalin, ) . residents were selected on the basis of willingness to take part in a garden intervention that involved placing containers and plants in their front gardens. participants received the same style of containers, range of plants and growing information, although the layout could vary based on the actual dimensions of individual front gardens or activities therein. for example, access to domestic bins, often situated in front of the property, had to be maintained. residents were consulted on the types of plants they preferred and a standard list developed (table ) , which were then used in the intervention (fig. ) ; all residents receiving the same plant taxa, the exception being choice of tree species -amelanchier or juniperus, or ability to decline a tree completely. residents received one tree, one shrub, one climber, and enough sub-shrubs, bulbs, and bedding plants to fill the two containers. this provided diversity in structure, colour, and seasonality for each resident. containers were planted by the researcher with no obligation for the resident to be involved with planting or subsequent management of these. all containers were 'selfwatering' with a l in-built reservoir of water. although residents were not obliged to maintain the plants, active participation was encouraged and access to horticultural advice provided through the royal horticultural society advisory team. residents were also given an information booklet written in a style accessible to non-gardeners. a number of parameters were measured as indicators of health status through questionnaires and cortisol sampling and are linked to our original questions (q - ). these were-primary health outcome measures: • perceived stress scale (cohen, kamarck, & mermelstein, ) a item scale scored on a likert ranking of (indicating higher stress) to (indicating lower stress) (q ). • diurnal cortisol levels and profiles (adam & kumari, and see protocol outlined below) (q ). • subjective well-being: short warwick and edinburgh mental well-being scale -swemwb (tennant et al., ) ; widely used in the health service sector with self-reported scores ranging from (low) to (high) mental well-being (q ). • physical activity levels (likert - scale, being inactive, being fully active) (q ). the questionnaires were also used to provide additional information on connectedness to nature (mayer & frantz, ) . this was a item scale scored on a likert ranking of (completely agree) to (completely disagree) relating to experiences of nature (q ). salivary cortisol data was collected following the procedures outlined by roe et al. ( ) . this data allows the modelling of trends and changes in the daily lives of research participants (schlotz, ) . diurnal cortisol profiles (declines after waking -see introduction) were monitored by collecting saliva samples four times a day ( , , , and h after waking) for each individual for two consecutive days with cotton swabs and salivette collection tubes (smyth et al., ) . participants were asked to confirm waking time on each day. to maximise participant adherence to the sampling protocol, they were subsequently sent sms text reminders min before a sample was due to avoid eating, drinking, or smoking (which can interfere with cortisol analyses), and when it was time to take the sample. samples were stored in domestic refrigerators for up to h before collection, then stored at − °c within a university laboratory prior to analysis. cortisol concentration was determined by enzyme linked immunosorbent assay (elisa) developed by salimetrics llc (usa). assay characteristics: standard range = . - . nmol l − , assay sensitivity = . nmol l − (lower limit of detection), correlation with serum cortisol = . (p < . , n = samples). after centrifuging thawed samples at rpm for min, duplicate analysis of samples was undertaken. the intra-assay coefficient of variation was < % for all samples. cortisol samples that indicated possible non-compliance with the (▲=garden intervention; ○=cortisol samples; ■=questionnaires and ♦=interviews). data was pooled for pre-and post-questionnaires due to not all residents completing questionnaires on each occasion. where an individual resident repeated the questionnaire, e.g. after the intervention, then mean scores were used in the subsequent analyses. sampling schedule were excluded following recommendations by dmitrieva, almeida, dmitrieva, loken, and pieper ( ) . these were extremely high values (≥ nmol l − ) or samples that demonstrated a rapid increase from the previous value (≥ nmol l − ). four aggregate measures were calculated: . daily average concentration (dac) (nicolson, ) , calculated as the daily mean of the four samples. . daily total secretion -area under the cortisol curve with respect to ground level (aucg), calculated using the trapezoid formula (pruessner, kirschbaum, meinlschmid, & hellhammer, ) . . diurnal cortisol decline (slope profiles of cortisol curves) (adam, hawkley, kudielka, & cacioppo, ) . slope was calculated as the difference between cortisol concentrations at and h post-awakening. . proportion of healthy 'i.e. normal' diurnal cortisol profiles (miller et al., ) . using discrete cortisol profiles (dmitrieva et al., ) , this assesses the proportion of curves that fit the normal diurnal cortisol profile. a cortisol profile is considered to be healthy if it peaks within the first hour of awakening, declines rapidly over the morning hours, and tapers off through the rest of the day, reaching its lowest point at night (saxbe, ) . cortisol reference ranges were used to determine healthy diurnal cortisol profiles. each resident's raw diurnal cortisol profiles pre-and post-intervention were classified into one of four categories following miller et al. ( ) : ) normal or healthy slope, ) low slope, ) irregular slope, ) elevated evening slope. changes in the number of samples showing a healthy profile were related to pre-/post-intervention times. in addition to the formal scores generated for perceived stress, wellbeing, level of physical activity and connectedness to nature, the questionnaire also posed further questions relating to feelings of happiness, relaxation, anxiety or depression experienced over the period of the intervention (q ); and any changes in social-cultural aspects such as perceptions about the local community or neighbourhood (q ) or connectedness to nature (q ). these complemented qualitative data collected via interview (see below). qualitative data was collected through semi-structured in-depth interviews, before and after the intervention. data included how residents felt about their lives, well-being, mental and physical health, street, neighbourhood, community, engagement with nature and gardening, attitudes towards the intervention, motivations for participation in the research and expectations regarding the outcomes of the intervention. throughout the study period, additional qualitative data was collected about alterations to gardens (both experimental and otherwise) and based on informal conversations with passers-by and neighbours. residents were inconsistent in their responses to requests for questionnaire or salivary cortisol data, resulting in a larger population in group a, than group b ( table ). as such, data for cortisol was pooled across both groups before comparing profiles pre-( weeks before) to those post-intervention ( months after). similarly, for well-being and perceived stress, data was pooled across the groups to allow for robust analysis of pre-and post-intervention effects. missing datasets did not fit a pattern, and tended to be related to individuals forgetting to provide samples or not being at home when interviews had been arranged. there was no evidence that any particular socio-economic or health factors were influencing the data sets (e.g. missing values were not restricted to those with the poorest health), so although statistical power was reduced, no obvious bias was linked with this loss of data. a range of statistical tests (using 'r' version . . ) were employed, as appropriate to the data, to determine statistical significance of the intervention. these included paired t-tests, mcnemar's test, linear modelling, single and repeated measures anova for pre-and post-intervention evaluation; a difference-in-difference regression model was used to compare results from intervention and control groups across different times. (table summarises the tests used for each parameter). where appropriate to do so, statistical power was increased by augmenting with additional individuals who provided data at relevant time points or restricted comparisons (see n values below for each specific statistical test/model used in the results section). in the process of this statistical analysis, model checking was performed by consideration of standardised predicted values, standardised residuals and whether the data met the assumptions of homogeneity of variance and linearity. transformations were carried out where appropriate to ensure compliance with these assumptions. for example, to correct for a positive skew in the cortisol data, data was log-transformed prior to statistical analysis. longitudinal qualitative data were analysed using interpretative phenomenological analysis (smith, jarman, & osborn, ) with time (pre-and post-intervention) as the main topic of inquiry. to maintain anonymity yet provide context, residents are cited using their gender and age to illustrate the emerging emotional themes. after a total of house-approaches, ( %) residents took part in the research with the majority of residents ( %) being white (table ). four residents who took part, co-habited, thus there were horticultural interventions in total. only residents chose to have a tree planted ( %). beyond watering, residents actively engaged with their new gardens, such as deadheading flowers or adding plants ( %). in terms of data collection, residents in total ( group a; group b) completed pre-and all post-interviews/questionnaires and ( group a; group b) provided complete cortisol profiles pre-and post-the intervention. pooling data across both groups (n = ) showed there was a significant decrease in perceived stress post-intervention, (paired t-test, t ( ) = - . , p = . ; q ) (fig. ). there were no significant effects though on subjective well-being (q ), physical activity (q ) or connectedness to nature scores (q ). restricting data to a single period (aug ) when group a (after the intervention) could be compared to group b (control, i.e. no intervention) at the same time, resulted in mean perceived stress levels of . and . , respectively. anova showed this to be only significant, however at a % level, i.e. p = . ; possibly partially attributed to low replication (n = ). a difference-in-difference regression model showed that perceived stress levels overall decreased by . in the intervention group, whereas stress levels actually rose by . in the control group (fig. ) . although this result is not statistically significant (p = . ), it does suggest that the engagement with the researcher alone (control group) had no positive effect on perceived stress scores. a repeated-measures anova factoring sample day and sample time revealed no significant order effect for day or of sampling using logtransformed values (n = ). there was a significant main effect of sampling time (f = . , df = , p = . ), indicating that cortisol means varied across the day. both results suggested participant adherence to the required sampling protocol and legitimised averaging cortisol variables (dac, aucg and diurnal decline) across the two sampling days to give the most reliable measures (roe et al., ) . a paired t-test run on the residents with measures both pre-and post-intervention (n = ) showed a marginally non-significant effect, with pre-intervention concentrations ( . nmol l − ± . ) lower than post-intervention ones ( . ± . ), t( ) = . , p = . . further evaluations using simple linear regression (log-transformed values) indicated a significant relationship between the pre-/postfactor and dac (t = - . , p = . ). dac increased by % from pre-to post-intervention, and the adjusted r value showed that . % of the variation in dac can be explained by the model, (p = . ). before the intervention cortisol levels tended to be very low (≈ - mol l − ), but were higher post-intervention (≈ - mol l − ) (fig. ) . these post-intervention values were closer to reference ranges from healthy participants of similar age and socio-economic status as this sample (smyth et al., ) . a paired t-test on aucg data (n = ) showed residents significantly increased their total secretion post-intervention (aucg = . ± . ), compared to pre-intervention (aucg = . ± . ); t( ) = . , p = . . again linear regression showed a significant relationship between the pre-/post-factor and aucg (t = - . , p < . ) with % of the variation in aucg being explained by the model (p < . ). a paired t-test (n = ) conducted on the diurnal decline (difference between concentrations at and h post-awakening) indicated that declines were significantly steeper post-(- . ± . ) than preintervention (- . ± . ); t( ) = - . , p = . . linear regression though, did not show a significant relationship between the pre-/post-factor and cortisol decline (t = - . , p = . ). a two-way repeated measures anova (n = ) was also conducted to determine the effects of time (pre-or post-intervention) and sample ( or h post-awakening) on cortisol. this showed there was a significant two-way interaction between the effects of time and sample on cortisol: f( , ) = . , p = . ; suggesting values were different at h, but not necessarily at h post-awakening (fig. ) . the cortisol decline post-intervention was strongly-negatively correlated with well-being scores. this was significant (r = - . , n = , p = . ); cortisol profiles in participants with higher well-being scores showed a steeper decline in cortisol concentration and in line with what would be expected in healthy individuals. for residents providing both pre-and post-diurnal cortisol profiles (n = ), the proportion of healthy slopes rose from % pre-intervention to % post-intervention. an exact mcnemar's test showing this change to be significant, χ = . , p = . . analysing all post-intervention questionnaires (n = , i.e. pooling data across those that had and had not completed a pre-intervention questionnaire) indicated all residents ( %) felt somewhat or extremely happy with their new front garden, and % also reported that their health or well-being had improved as a result of the intervention. twenty-two residents ( %) reported that the garden helped them to feel happier, residents ( %) reported that the garden helped them to relax, and residents ( %) reported that the garden made them feel more connected to nature (fig. ). relatively few residents ( ), however, reported that the gardens directly reduced feelings of depression, worry or anxiety. moderate numbers reported an increased sense of pride ( ) and more social contacts ( ) through the questionnaire. four key themes emerged from the qualitative data analysis (interviews). introducing plants elicited feelings related to motivation, relaxation, pride and positive emotions. the intervention motivated residents to engage with their new planters, add additional plants ( residents) or garden furniture, and renovate other parts of the house/garden. one participant (male, ) fig. . salivary cortisol concentrations (mean ± standard error) pre-and postintervention (n = ). data for healthy participants from laboratory reference data and included for illustrative purposes; n = , women and men aged . ± . years (but also see smyth et al., smyth et al., , smyth et al., , . bars represent standard error (s.e.). bought a paddling pool for his dog to play in, while spending time in the front garden. a participant with paranoid schizophrenia described the importance of seeing positive change for her home: "it's the one part of the house that's nice at the moment, so it makes a difference. it definitely makes you think about the rest of the house and getting on top of things, so i'm having the back garden done next week. it's started me off; if you get a lift up, it sort of spurs you on. it definitely gets you motivated a bit more" -female, . residents also stated they were encouraged by the responsibility to care for the plants. this was especially the case for residents with chronic depression and other mental illnesses, who appreciated change in small steps. one participant described feeling "like a normal human being" when seeing the plants outside her door (female, ). the intervention influenced neighbours who had not directly participated in the research, and these purchased plants, containers and artificial grass for their own properties. one resident requested a 'plant list' so she could have a matching display for her own front garden. the majority of residents reported that it was relaxing to view the plants, come home to them, and watch them grow. "one of the big things that i've noticed, is when i come back from work and see all the daffodils, it switches me into home mode. it's like a buffer zone between work and home." -male, . one participant caring both for her ill mother and granddaughter amidst her own relationship problems, explained that sitting on her front step, next to the plants, with her morning coffee helped her cope when she did not otherwise have time for herself (female, ). the new plantings gave residents a sense of pride in their home. the interventions took place in areas with frequent fly-tipping and theft. a large proportion of participants explained that the "nice planters" would improve people's perception of the area, as well as their own. "you don't want visitors to think you live in a dump, you don't want them to pity you. […] it gives you pride, not just in your house but in the whole area. it makes it look like your area has not just been left to rot." -male, . residents noted that the colourful planters became an indicator of care, and a catalyst to pay more attention to the neighbourhood. one resident (male, ) was inspired to become a local council 'street champion' and took part in litter picks. this improved 'sense of pride' was cited as improving communication between residents and contributing to a genuine sense of community. some residents also felt an increased sense of responsibility for the plants themselves. "it is quite relaxing, but i never thought i'd say this. i'm quite attached to them now. it sounds weird because they're only plants, but they're not. they're mine. and they are living things, so you've got to look after them. it's like having a little pet." female, . all residents reported that the plants made them feel more cheerful and lifted their emotions when viewing them. they talked about better moods upon leaving/returning to the house. though experienced by all, qualitative assessment of emotional intensity during interviews suggested that this was most acutely appreciated by people struggling with poor mental health. the importance of the visual impact/flower colour was explained by several residents, and residents' home visitors also noticed the changes. "it's just nice to see the different colours. otherwise, it looks dead bare. it made me feel brighter in myself" -female, . results from the intervention support the notion that small-scale ornamental plantings improved residents' mood and self-reported health with respect to perceived stress (fig. ) . improvements in participant self-reported data were supported by aggregate measures of salivary cortisol concentrations, with a number of cortisol parameters suggesting significant improvements in cortisol patterns and traits associated with better health (q ) ( out of of our cortisol analyses showed a statistically significant difference at the % level). the significantly steeper declines in cortisol slopes observed postintervention indicate better health through more effective regulation of circadian and hormonal mechanisms, i.e. a likely consequence of reduced stress. the proportion of cortisol curves showing a healthy pattern increased significantly (by %) after plants were provided to residents. indeed, empirical values post-intervention ( % normal) were comparable to other studies for healthy individuals in similar demographic groups (ice, katz-stein, himes, & kane, ; ryan et al., ; smyth et al., ) . improvements in cortisol profiles were mirrored by significant increases in total daily cortisol secretion (aucg) after the horticultural intervention. very low values of aucg are often associated with chronically low socio-economic status and poorer health (desantis, kuzawa, & adam, ) , and increases in this parameter also suggest improvements in health status. finally, we noted an increase in the daily average concentrations (dac) of cortisol after the intervention, again to levels consistent with populations of healthy individuals. higher dac is associated with a higher cortisol awakening response, which in turn has been linked to lower perceived stress (o'connor et al., ) . overall our data suggests that for this population cortisol levels and profiles were considered 'healthy' post-intervention, but indicated poor health status pre-intervention (smyth et al., ) . indeed, the 'blunted' cortisol levels below reference ranges encountered pre-intervention are linked to depression (adam et al., ) , post-traumatic stress disorder (bechard, ) , suicide attempts (keilp et al., ) and childhood adversity (koss & gunnar, ) through the down-regulation of the hypothalamic-pituitaryadrenal (hpa) axis after prolonged exposure to chronic stress. overall, the increase in the number of cortisol curves with a healthy pattern after the intervention suggests that more residents were experiencing less hpa fatigue, stress, anxiety, sleep disturbances, or irritability. comparing the data on perceived stress in this study to others, the positive effects due to the horticultural intervention were approximately equivalent to weekly mindfulness sessions (as measured after months) (van wietmarschen, tjaden, van vliet, battjes-fries, & jong, ) . thus, the data addresses q and q , indicating the intervention reduced perceived stress levels, improved cortisol profiles and thereby had a positive effect on the residents' health status. although there was no significant increase in swemwb scores per se (q ), lower perceived stress and positive physiological responses after the planting intervention were supported by positive statements in the questionnaire. all residents reported that their health or well-being had changed for the better due to the new front gardens; the gardens were also reported to help residents feel happier ( %), more relaxed ( %) or more connected to nature ( %) (fig. ). moreover, many or the qualitative personal statements clearly articulated the positive influence the gardens had on peoples' outlook on life, with strong themes developing around more positive attitudes in general, a sense of pride and an enhanced motivation to improve the local environment, as well as the gardens being valued as a place to relax. therefore, there is some evidence the intervention provided socio-cultural benefits (q ). the intervention did not show any significant differences on either subjective well-being (swemwb) (q ), enhanced physical activity (q ) or connectedness to nature outcome measures (q ). the lack of direct relationship between the horticultural intervention and subjective wellbeing score is surprising; especially as it at odds with the data on stress, a potential precursor of certain aspects of poor mental health (toussaint, shields, dorn, & slavich, ) . this suggests that the intervention might relieve stress, but not necessarily be influencing other aspects of well-being, such as feeling loved or having increased confidence (aspects covered within the swemwb scoring). certainly, other studies on therapeutic gardens and engagement with nature have suggested that there can be misalignment between the positive effects on day to day stress management and such activities being an antidote to deeper or longer-term mental health problems (toussaint et al., ) . the lack of any enhancement in connectedness to nature score (q ) from the intervention is interesting too. this may partially due to the fact that the residents who chose to take part, already had some desire to have plants in their garden, possibly suggesting a higher nature connection level than a genuinely random control group. this skew in participants may be one reason why the nature connection measure did not change from pre-installation to post. it is also possible that an interest in gardening and nature connectedness are not exactly aligned. although on the one hand, gardening, is by definition, working and being in close proximity to nature through the medium of plants (and predominately cultivated forms of plants), it is not necessarily engagement with 'wild nature' per se. we saw no strong evidence of residents showing wider engagement with other aspects of urban wildlife, or mentioning taxa other than plants. it is possible that the horticultural intervention was inducing positive affect, as indicated by the qualitative data, but not necessarily just that associated with biophilic responses (wolf, ermgassen, balmford, white, & weinstein, ) or biodiversity (richardson, ) . gardens have been linked to an enhanced sense of self-worth through the opportunity for increased creativity, and self-expression (clayton, ) . as mentioned above, they can also be a source of pride (clayton, ) or improve a sense of place (freeman, dickinson, porter, & van heezik, ) as this study confirms. these positive aspects of gardens in sociocultural terms require further investigation using additional outcomes measures that capture these dimensions. as far as we are aware, this is the first study to evaluate the health benefits of a small-scale front garden horticultural intervention. moreover, the research was innovative in that ornamental landscape plants were used exclusively in an attempt to differentiate responses based on emotion to those of material need (i.e. food). many previous garden studies indicate food crops were grown, yet the motivations to grow food and non-food plants may be different. the focus here was purely on an aesthetic transformation to the front garden. taken in the round, these datasets indicate the horticultural intervention reduced the level of stress in residents (as captured by both selfreporting q and a physiological biomarker q ) at least in the shortmedium term (over a month period). the positive findings from this study have wider implications for urban planning. as outlined above, there is a trend in urban planning to save space by providing housing with little or even no garden space (ltd, ) . most research on salutogenic aspects of ugs have focussed on parks (wolf & wohlfart, ) , nature reserves (adjei & agyei, ) and urban forests (panagopoulos, gonzález duque, & bostenaru dan, ) , including trees close to residential properties (taylor, wheeler, white, economou, & osborne, ) and policy makers are beginning to acknowledge the value of such spaces in this respect (lee, jordan, & horsley, ) . policymakers and planners should not feel, however, that such places can necessarily directly substitute for private gardens and the health benefits they provide. private gardens are distinct from other forms of ugs in a number of important ways. they provide an opportunity for citizens to engage with the natural world in an immediately accessible manner, while also being imbued with social and cultural elements. the privacy component alone allows autonomy and opportunities to be creative or reflective in a way that would rarely be feasible in public ugs. even the social dynamics around domestic gardens may be different from that of communal gardens or allotments, despite the physical activities being very similar. they are also intrinsically linked with the domestic property and can enhance (or if poorly maintained, undermine) the sense of pride that can be aligned with homeownership. one of the principal findings from this research was the capacity for ornamental gardens to provide an immediate, accessible and easily sought place for relaxation. in effect, an important location for some 'down time' and a place to find respite from the stress and strains of urban life. the surprising element, perhaps, was how little green space was actually required to accrue these benefits. the key limitation was attrition in sample size over time; a common problem in longitudinal studies. the logistics of carrying out a longitudinal study in a deprived urban community included participants' failure to respond at specific sampling times, forgetting to take samples or meet for interviews (despite being prompted). data was tested to ensure those residents who omitted samples/missed interviews were not atypical of the population in general. for example, residents who dropped out were not correlated with more irregular cortisol profiles than those who finished the evaluation. further studies, however, should take care to ensure that later omissions are not in themselves associated with poorer health or greater stress levels. it is recommended that similar studies are conducted with larger sample sizes for higher sample power. the horticultural intervention relied on a relatively small volume of new plantings, and was facilitated by both the local housing association and the royal horticultural society. questions remain as to the impact of the number of plants used, garden style adopted, and social context (community grassroots initiatives vs. top-down local authority programmes). it should also be noted that although our data showed a positive trend between the garden intervention and i. perceived stress, ii. cortisol profiles that relate to less stress and iii. improvements in mood (trends not found in our control population), sample sizes were small, and we cannot categorically claim 'cause and effect'; other factors external to the project could also have been influencing these trends. although our groups a and b were chosen to be similar in sociodemographics, and by and large were, there was a higher proportion of homeowners in group a than b (as compared to tenants), and this may have influenced results. further research is required to note any particular influences in owning a garden as to managing one that is part of a rented property. finally, data from the connectedness to nature section of the questionnaire did not correspond well to some people's response to their own garden and this may relate to a mismatch between larger, theoretical components around nature and the more intimate feelings residents had for their familiar, small scale 'patch'. for example, residents may rarely have considered their garden when trying to address questions such as "when i think of my place on earth, i consider myself to be a top member of a hierarchy that exists in nature". perhaps a stratified or modified questionnaire is required when attempting to assess affinity to green space or urban nature per se? the data presented suggests that adding plants and containers to residents' front gardens was associated with significant reductions in perceived stress (q ) which was reflected in improved diurnal cortisol patterns (q ) post-intervention (i.e. steeper diurnal declines, increased daily average concentration and total secretions compared to 'blunted' levels pre-intervention). qualitative data also showed residents being happier, more relaxed, and having greater motivation to improve and feel a sense of pride in their living environment. we did not detect a significant improvement, however, in the subjective well-being scale -swemwb post-intervention (q ). in reality, it may be that certain components of well-being were improved but not others. data from the study also indicated that there were some socio-cultural benefits associated with the intervention (q ), for example being more 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on green space and associated mental health benefits is variety the spice of life? an experimental investigation into the effects of species richness on selfreported mental well-being walking, hiking and running in parks: a multidisciplinary assessment of health and well-being benefits. landscape and urban planning not all green space is created equal: biodiversity predicts psychological restorative benefits from urban green space the research project was compliant with uk and data protection acts ( , ) and was approved by the university's research ethics committee.funding this research was funded by the royal horticultural society, with contributions from forhousing and united utilities. the authors declare no conflict of interest. key: cord- -ys ezzzz authors: galea, sandro; keyes, katherine title: understanding the covid- pandemic through the lens of population health science date: - - journal: am j epidemiol doi: . /aje/kwaa sha: doc_id: cord_uid: ys ezzzz in a few devastating short months in , the covid- pandemic changed global mobility and interaction in ways that were unimaginable to many of the world’s population as recently as in . more than million people have, at this writing, been infected by sar-cov- globally, and more than , have died of covid- . as our science progresses, it is becoming possible to apply the principles of population health science to help us better understand the pandemic. what does a formal approach to population health science teach us about covid- ? building on our previously published work about the foundations of population health, we offer a few observations—a first draft of population health science thinking—as it intersects with the covid- pandemic. of note, our collective understanding of the pathology and causes of covid- are rapidly changing by the day, and thus we fully expect that this work will evolve and improve as science progresses. the recognition of a novel virus that posed, at the time, poorly characterized health threats, resulted in unprecedented global action. the world's attention turned to health, and to public health in particular. massive national efforts were undertaken to promote public health, and policies were implemented in the name of public health across the world. epidemiology become a common term on the front page of the world's newspapers, and epidemiologists suddenly found themselves thrust in the national spotlight perhaps more so than at any period since the beginning of the hiv/aids epidemic. this mobilization and spotlight on our field is in and of itself remarkable. it is a moment of opportunity-and of challenge-for population health science. much remains to be learned about the specifics of the covid- , including characteristics of the virus itself, and about the policies and behavior changes that mitigate its spread. we expect that the coming years will result in important insights to inform and be informed by population health science that will guide how we prepare for, and mitigate, future pandemics. we are also at a point, however, when some learnings are beginning to emerge, when we can begin to sharpen our thinking about covid- , seen through the lens of population health science. what does a systematic approach to population health science teach us about covid- ? building on a frame of our previously published work about the foundations of population health, we offer a few observations as a first draft of population health science thinking as it intersects the traumas of the moment, fully expecting that this work will evolve and improve in coming years. epidemiology lends itself to a focus on categorical outcomes, aiming to understand causes of cases. by contrast, a dimensional approach aims to expand that lens beyond simple case categorization, to thinking of the fuller range of health manifestation. for example, we may think of the full spectrum of blood pressure in populations rather than considering whether blood pressure is high or low. an infectious disease pandemic lends itself naturally to categorical thinking, as a focus on the acquisition of infection is a clear, and appropriate, priority. while this may not, at first blush, readily lend itself to dimensional thinking, covid- dynamics indicate that we best serve population health by thinking dimensionally across a range of health indicators, expanding our focus beyond clearly defined categorical outcomes, even in the case of an infectious disease pandemic. this recognition frames how we may think of the causes of the pandemic and how that may shape our approaches to it. consider the consequences of the novel coronavirus that constitute health indicators of interest. we are first concerned with cases of infection and deaths from the virus. but deaths from the virus may be due to a disease that is uncurable, or one that overwhelms the health system. hence, we should also be interested in hospitalization rates, and availability of acute care if it were needed to look after those sick with coronavirus. all of these are reasonable indicators of concern to population health. in addition, efforts at mitigating viral spread have now resulted in extraordinary economic shocks, second only to those experienced during the great depression. we know that these economic consequences will lead to health consequences. , this suggests that the economic indicators, and their health consequences should also be of concern to population health, ranging from increases in cardiovascular disease, depression, and suicide, all of which have been associated with adverse economic conditions. which of these health indicators matter most? they all matter, and all should be of concern for population health, as long as we understand our concern to be more than simple caseness linked to the infection, but with the full set of conditions that shape population health. this has complicated implications for policy making. if our only outcome of interest were viral caseness, it is certainly true that complete and prolonged efforts at population physical distancing are the approach best supported by population health science. remains much to be analyzed and written about the differences between the two states, it is likely that some combination of idiosyncrasy, physical distancing measures, and the weight of their implementation fundamentally shaped the population curve differences between both states. ample infectious disease modeling has, at this point, showed that physical distancing measures-ranging from stay-at-home or shelter-in-place orders, to use of personal protective equipment-ultimately determine spread of the disease, and in this case then inform inter-population differences. and yet, the epidemics in massachusetts and florida are marked by similarities, particularly around the extent to which the burden of mortality is disproportionately borne by persons living in assisted-living facilities. in both states more than half the deaths were among persons living in assisted-living facilities. the preponderance of cases in these facilities likely reflects the underlying likelihood of serious illness among persons with co-morbid conditions, and the limited capacity of contact controls within these facilities nationwide. hence, the causes of difference between these two populations were relatively distinct from the causes of similarity of the types of persons who were most affected within each of these populations. understanding this helps focus both on the causes of pandemic spread, and on the persons most at risk who could-with a more nuanced approach to the pandemic-have been more systematically protected, limiting the extraordinary mortality that characterized older age groups infected during this pandemic. second, we can consider an example moving beyond geography and thinking of particular population groups. we know that racial minorities, particularly black americans, are bearing a disproportionate burden of the coronavirus pandemic in the us. hence, the causes of greater incidence are likely directly tied to contemporary economic and occupational circumstance. by contrast, the causes of conditional risk of harmful consequences of the virus, that is the greater likelihood of death among those infected, are likely quite different than the causes of incidence, including age and underlying morbidity, which then patterns the differential likelihood of serious consequences from viral infection. thus, the causes of differences in the rates and timing of infections between the two states (e.g. physical distancing adherence) may be distinct from the differences in rates of infection or mortality within a state the conditions that create a healthier world around us are determinative of the causes of viral spread, both of persons who were likely to acquire the virus and persons who were likelier to get sick when they did acquire the virus. it is abundantly clear that persons who were less able to physically distance, whose occupational category precluded them from shifting to remote work, were likelier to acquire the infection in the early days of the pandemic when efforts at personal protection were nascent. in addition, the persons who were likelier to bear most of the morbidity and the mortality of covid- were persons who had pre-existing conditions that themselves are socially patterned over a lifecourse of exposure. for example, emerging data from the pandemic are showing that there is a substantial burden of mental illness, including greater than doubling of population mood anxiety disorders due to covid- . in addition, these data show that the burden of this mental illness is accumulating more among persons with lower incomes and who are otherwise marginalized. that the burden of poor mental health falls on these groups is, in many ways, to be expected, given the increased strain of stressful life events and underinvestment in public infrastructure for treatment well before the pandemic. hence, social patterning of pre-existing medical conditions predisposed populations to the consequences of sars-cov- . while this pandemic was novel in , its population health footprint was established long before the novel coronavirus crossed over into humans, following causes that are influenced by causes at multiple levels of influence, from national and state policies, to local conditions of exposure, to forces that shape risk of other diseases that in turn predispose populations to covid- infection and its consequences. one of the central stories of the covid- moment is, undoubtedly, one of inequity in its consequences. death rates from covid- among black americans is more than twice what it is among non-hispanic whites; rates are also higher among native americans. in addition, infection incidence is socially patterned with persons with lower income likelier to be infected and to experience more morbidity when they do acquire covid- . this is all compounded by the economic downturn that is affecting persons with lower income and people of color more than other populations. this all makes a strong case for the centrality of health inequities at the heart of the population concern with the covid- pandemic. it also, however, raises the question as to how much the world embraced an approach that prioritized health equity when faced with a novel coronavirus infection. the short answer to this question is, not particularly much. as countries all over the world scrambled to address coronavirus, efforts were put in place to stop the spread of an unknown pathogen, more or less at all costs. in the process, conditions for shut down were imposed that put essential workers at risk, without much heed to the conditions of those essential workers. we could have done this differently. for example, we could have prioritized personal protective equipment for all workers, recognizing that the riskiest and most difficult occupations are those that we de-prioritize for wages and create structural conditions under which worker safety is not valued. commensurately, little attention was paid to congregate populations, including for example those who were incarcerated and immigrants in detention, which soon came to experience infection rates that were substantially higher than that seen in the general population. why have we operated in this manner globally? in no small part we have operated on a narrative that has prioritized viral suppression at all costs. we have, as a society, rushed to do everything in our power to apply blunt instruments, often limited, to mitigate the spread of a novel pathogen. this was necessary at the time perhaps but was achieved at the expense of more vulnerable populations. could there have been an alternative approach? we were well aware that taking rapid and drastic action to contain viral spread using the blunt instruments of whole economic shut down was going to disproportionately disadvantage those groups who were already vulnerable. yet, we proceeded to do so anyway, being willing, in essence, to privilege overall morbidity and mortality reduction, often at the expense of disproportionate burden among the most advantaged. were we to have seen health equity as a core concern we would have moved quickly to change complete economic shutdown, perhaps to think creatively about personal protection and risk stratification that would have continued to allow viral control, but have prioritized social and economic livelihood as a core focus. covid- highlights therefore the tradeoffs we make between equity and efficiency and how these choices depend on a set of values, how policy decisions informed by epidemiology are contingent, whether we realize it or not, on the values that inform our thinking and our action. it also should call us to account for decisions made during the covid- moment and put to rest, once and for all, the notion that scienceinformed policy actions are value free. it calls for a population health science that is willing to engage with questions about the value that inform its work. to what extent, for example, did the early infectious disease models that informed many of the national decisions on global lockdowns also reckon with the disproportionate burden that these approaches would have on vulnerable populations? to what extent did we create tools to allow us to weigh the consequences of our actions in terms of costs for populations that already bear the cost of lifecourse burdens imposed by unfair economic circumstance? we suggest that we did little of this during the pandemic and stand to learn to do so in future if we are to balance equity and efficiency as we think about population health after future such events. unfortunately, this is consistent with our global history of failing to prioritize and focus on the health of marginalized populations. covid- gives us an opportunity to re-envision how we create and demand equity, to create a shared understanding that the priority of population health should be creating structures for all to thrive. one of the central challenges that we face in population health science is a focus on isolating casual effects of single exposures on outcomes, often to the detriment of understanding co-occurring causes that interact with, and inevitably shape, the very presence and magnitude of the exposure effect itself. this is abundantly in evidence in our science in the case of the covid- pandemic. we were interested centrally, perhaps understandably, in the consequences of sars-cov- . in this case our exposure was the virus, and the disease was covid- . there was an explosion of biomedical publishing about this relation, and the causal thinking xy is that the virus x, is associated then with the disease, covid- , as y. but to what extent is xy informed by z, a co-occurring cause that interacts with x, and in whose absence the x y relation may be different, or even absent? this is, of course, the essence of biological interaction, and determines why we see heterogeneity of associations in different contexts. understanding that this relation exists puts us on a very different path of inquiry than thinking of all potential z variables as alternate explanation, confounders, that require being adjusted for, or being explained away, rather than being seen as part of the mechanism that explains how the cause manifests as disease. take, for example, in the context of sars-cov- , the role of age. we now know that age, likely both as a marker of underlying co-morbidity, and of immunosenescense, is associated with greater risk of both acquiring sars-cov- , and of death from covid- once the disease is acquired. this suggests that age interacts with the other causes of infection (exposure risks due to physical contact for example) as well as with other causes of morbidity (underlying diabetes or heart disease for example) to be a factor as important as the virus itself in determining the scale and consequences of the covid- pandemic. while surveillance rapidly came to recognize the unique role that age played in this pandemic, we fell far short of recognizing the import of this observation. as a result, throughout the us more than % of all deaths from covid- are among persons older than the age of . we suggest that the gap between our vital statistics observation and our action to prioritize protection of people in particular age groups would have been in part minimized by a focus on epidemiological methods that assess interaction. the absence of comprehensive interaction assessments underlies our failure to understand that the magnitude of an effect of exposure on disease is dependent on the prevalence of the factors that interact with the exposure. countries with more older people, like italy, had substantially worse consequences of covid- than did countries with younger people. this reflects, rather simply, the central importance of age as an important, even if insufficient, covariate (i.e., age by itself, without sars-cov- infection does not result in covid- ), one that changes our understanding of the disease through its intimate interaction with the key exposure, and should accordingly inform our public health action. perhaps the ultimate observation of the covid- pandemic is the centrality of prevention to the work of population health science, and the consequent work of public health. the covid- pandemic has, as of this writing, infected more than million people worldwide, and resulted in more than , deaths. in the us alone, about million people have been infected, and more than , people have died. current estimates are that the global cost of the pandemic will be about $ trillion; in the us costs to the economy are currently estimated at $ trillion. , these are extraordinary costs for a pathogen that was unknown as recently as at the beginning of this year. they also far outweigh the costs of prevention. separate and apart from the human costs, measured in morbidity and mortality that would not have there are of course other considerations when thinking about our return on investment for efforts that mitigate the consequences of this pandemic. we now know that persons with underlying co-morbidities are substantially more likely to experience adverse consequence of sars-cov- infection than persons without these co-morbidities. these co-morbidities themselves are a result of disinvestment in population health that results in preventable disease and death, that itself costs the us economy more than $ trillion annually. we know that we can reduce morbidity and mortality if we invest in reducing disease that is, at core, preventable. now we recognize that in so doing we would also be creating a population that is healthier and more robust to the consequences of this particular pandemic and almost certainly to the consequences of future pandemics. can this make the point sufficiently for a wholesale investment in prevention once and for all? we are in early stages of our understanding of the full scale of the population health implications of the events of . we expect that in coming years as data emerge, our thinking about the causes and consequences of the pandemic will sharpen and clarify. however, even with this state of our understanding, the principles of population health science can help us better understand the pandemic, its causes and consequences, and how they may shape our efforts at mitigation in the current moment and with future pandemics in mind. we hope, in particular, that this approach can help inform the architecture of our thinking, providing a scaffold for future population health science. population health science mental health outcomes in times of economic recession: a systematic literature review economic crises and mortality: a review of the literature the covid racial data tracker how much do we spend? creating historical estimates of public health expenditures in the united states at the federal, state, and local levels covid- and underinvestment in the health of the us population factors associated with depression, anxiety, and ptsd symptomatology during the covid- pandemic: clinical implications for u.s. young adult mental health why does covid- disproportionately affect older people? population age structure: the hidden factor in covid- mortality the cost of chronic disease in the us prevention of chronic disease in the st century: elimination of the leading preventable causes of premature death and disability in the usa key: cord- - n jp l authors: baatiema, leonard; sumah, anthony mwinkaara; tang, prosper naazumah; ganle, john kuumuori title: community health workers in ghana: the need for greater policy attention date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: n jp l from the s to the s, the who, united nations and other agencies mooted the idea of formally training and recognising community health workers (chws) to complement efforts to improve primary healthcare delivery in low and middle income countries. recently, chws have been recognised as important players in the achievement of the health-related millennium development goals (mdgs). despite this recognition, little understanding exists in ghana about the activities of chws: who they are; how they are recruited; what they do; level of health policy support; contribution to healthcare delivery and the challenges they face. based on a rapid scoping review of the existing literature, and our experience working in ghana, this paper reflects on the role of chws in healthcare delivery in ghana. we argue that chws have played critical roles in improving health service delivery and outcomes, including guinea worm eradication, expanded immunisation coverage, maternal and child health, and hiv/aids treatment and management. however, these achievements notwithstanding, chws face challenges which prevent them from being optimally productive, including capacity problems, neglect by the healthcare system, high attrition rates and inadequate supervision. policymakers in ghana therefore need to give increased attention to chws, provide remuneration for their activities, create career opportunities and other means of motivations to boost their productivity and sustain gains associated with their activities. the concept and role of community health workers (chws) have enjoyed renewed interest in global health since the alma-ata declaration in . [ ] [ ] [ ] [ ] [ ] [ ] chws have evolved over the past decades with its antecedence in the 'feldshers' in th-century russia, the barefoot doctors programme in china during the early s, and the who seminal work 'health by the people' in . recent recognition that chws are important players in global efforts to achieve the health-related millennium development goals (mdgs) highlights this attention. in , the one million chws campaign project worth us$ . billion was announced to boost the capacity of chws to deliver healthcare in sub-saharan africa. this current drive to recruit more chws is a recognition of their role in sustaining the mdg gains, as well as in ultimately achieving the more recent sustainable development goals (sdgs). a surge in the evidence of their contribution has recently been acknowledged in a cochrane review on maternal and child health. evidence in several low and middle income countries (lmics) suggests that marked reductions in child and maternal mortality through health promotion interventions, immunisation campaigns and other community driven initiatives could be attributed in part to the role played by chws. [ ] [ ] [ ] [ ] [ ] key questions what is already known about this topic? ▸ the contributions of community health workers (chws) to healthcare delivery have been recognised globally. ▸ there is a lack of global consensus on chws' scope of practice. ▸ there is inadequate health policy support for chws in low and middle income countries. what are the new findings? ▸ this analysis presents systematic and comprehensive evidence of chws' contributions and health policy gaps in ghana. ▸ it has contributed in clarifying the various classification of chws and their scope of practice. ▸ it has also highlighted evidence of inadequate health policy support for chws. ▸ the formulation of a national policy on chws. ▸ the establishment of a professional and regulatory body to regulate the standards and practice of chws. ▸ the development of a long-term strategy that will see the gradual replacement or absorption of chws into the formal health service in ghana. with the current ageing population and wave of epidemiological transition globally (the impact of which is projected to be felt more by populations in lmics), studies suggest that chws are rising to the task of ensuring that the impact is less felt by communities and health systems. [ ] [ ] [ ] the potential contributions of chws to tackling the current global health security threat posed by the zika virus, yellow fever, middle east respiratory syndrome (mers) and influenza, especially in the area of surveillance, cannot be overemphasised. despite the general consensus about the importance of chws among the global health community, health policy interventions to recognise and support optimal delivery of healthcare by chws are lacking, especially in lmics. in ghana, although a number of studies and reports have highlighted chws' activities, there is inadequate health policy support for them. to the best of our knowledge, no studies currently exist in ghana to have systematically profiled chws and their contribution to healthcare delivery. there is yet no consensus or comprehensive assessment of their roles, scope of activities and constraining factors to their productivity in ghana. this analysis paper therefore addresses this knowledge and policy gap. to analyse the activities of chws and the extent of health policy support in ghana, we conducted a literature review of published and unpublished works, including reports on the activities of chws in ghana (see box for search strategy deployed to search and retrieve relevant literature for this study). this paper also incorporates insights from our experiences of working in ghana as community health services researchers, affiliates of the ghana health service and development workers who have contributed to the design and implementation of numerous community-driven health interventions in collaboration with chws. despite an international consensus about the importance of chws to healthcare delivery, a universal definition of chws remains evasive. ambiguity further abounds in the mainstream literature on the characterisation of chws. however, during the recent united states agency for international development (usaid) chw evidence summit, there was some consensus that a chw is "a health worker who receives standardized training outside the formal nursing or medical curricula to deliver a range of basic health, promotional, educational, and mobilization services and has a defined role within the community system and larger health system". we find this definition to be insightful and thus will significantly support our analysis of chws in this paper. in ghana, two complementary types of chws are notable. the first category are an informal, poorly trained health service-supporting chws. in this category, chws are informally a part of the health system, and the health authorities or collaborating development partner (non-governmental organisation, ngo) takes responsibility for their recruitment, training, incentives and/or remuneration. the second strand of chws exists where chws are representatives of the community and act in the interest of the community. chws under this category have no or limited affiliation with the formal healthcare system, and mainly spearhead community-driven preventive health activities. despite this distinction, we admit that many chws might be combining both roles in practice. from our experiences and in our view, a 'hybrid' form of chws (a mix of the two categories) can be found in ghana. similar to the international trend, chws are diversely named in ghana, including but not limited to names such as community health volunteers (chvs), traditional birth attendants (tbas), village health volunteers, community health champions, peer health educators, community child growth promoters, community nurses, community health committee members, community-based surveillance volunteers (cbsvs), community-based agents and lay health workers. - these different characterisations generally reflect the diverse and ambiguous identities of chws in the international health literature and in health policy programmatic interventions. - for the purpose of clarity, we refer to chws in this paper as any of the above category of health workforce who, though not formal employees of the health system in ghana, are either a health service-supporting chw or community representatives, who have been identified, a rapid literature review of both published and unpublished works was conducted in academic science complete, cinahl, embase, global health medline, google scholar, isi web of knowledge, popline pubmed, psycinfo and web of science. no year limit was included in the search. we also undertook a review of reports on the activities of community health workers (chws) in ghana. the search sought to retrieve relevant documents ( programmatic and scholarly reports) on the activities of chws, especially in ghana, using key words such as community health workers, chw, village health worker, community health volunteer, lay health worker, traditional birth attendants, tbas, health promoters, ghana, remuneration, financing, health policy, impact, activities, training, practice and training. relevant papers and information were retrieved and reference lists screened for more relevant studies. studies which discussed the activities of chws with particular reference to ghana were critically assessed for relevant information. in order to establish the activities of chws in the context of the globe, works related to chws in general were included based on relevance to the study aim. in addition, the scope of the literature included in this paper was confined to works which reported, described, analysed and synthesised the activities of chw in the context of ghana. importantly, the paper incorporates insights on the activities of chws through anecdotes, authors' personal experiences and field reports. trained or untrained, and assigned roles in the community for which they receive no or some form of formal remuneration. historically, chws such as tbas have operated in most ghanaian communities. however, attempts to formally organise and recognise them came after the alma-ata declaration on primary health care (phc). village health workers (vhws) provided the first semblance of chws in ghana. these were local community representatives whose actions and activities were mostly based on altruism. although their roles such as community mobilisation, health awareness creation and immunisation campaigns were critical to the modest gains ghana achieved from implementing the phc strategy, their activities were short-lived such that by the s, vhws were no longer used. lack of coordination and inadequate supervision of their activities were among the reasons why the vhws programme was discontinued. as a result, community health nurses (chns) were introduced to deliver healthcare in mostly deprived parts of ghana. unlike the vhws, chns were recruited, provided professional training in nursing training colleges, deployed into mostly rural parts of ghana and formally remunerated to provide healthcare. however, the relatively long period needed to train them and funding challenges limited adequate training and deployment of chns. consequently, the activities of vhws were reinvigorated in the early s. central to their re-emergence was the navrongo experiment, a pilot project which culminated in the current community-based health planning and services (chps) concept. since then, chws have continued to evolve both in name and role. currently, cbsvs form the majority of chws in ghana. however, there is still lack of clarity on their contribution, recruitment, scope of practice and remuneration. chws: contributions to healthcare in ghana evidence of the success of a plethora of community health interventions supported and delivered by chws exists in the international health policy and systems research literature. although chws are involved in many domains of healthcare delivery in ghana, our review identified four important areas where chws' contributions have been immense. these four areas are examined in this paper. the navrongo experiment is one of the areas where chws' contributions to healthcare delivery have been acknowledged globally. the navrongo community health and family planning project, popularly referred to as the navrongo experiment, which culminated in the birth of the current chps programme in ghana, sought to improve access to healthcare in deprived communities using mostly community-driven resources and structures. the intervention was conceptualised under the assumption that by recruiting, training and deploying community health officers to rural communities, inequities in access to healthcare services between urban and rural settings could be bridged. under the navrongo experiment, chws played several critical roles, including outreach services, community mobilisation for health educational talks and referral to health facilities. the navrongo experiment resulted in increased access to healthcare services, immunisation coverage, reduced child and maternal mortality while improving the rural population's overall health. for example, within a period of years of its implementation, the results pointed to a % reduction in childhood mortality rate and % reduction in fertility rate. given this landmark success, results from this experimental intervention led to the conceptualisation and implementation of the chps programme as the country's main policy enactment aimed at improving access to health services in rural ghana. owing to its overall success, ghana's chps programme has been acclaimed as among the most successful community-based health programmes globally. [ ] [ ] [ ] [ ] guinea worm eradication without the diverse contributions of cbsvs, ghana's current success in eradicating the guinea worm (dracunculiasis) would have been unlikely. ghana was ranked second globally in among the guinea worm endemic countries. currently, however, ghana is guinea worm free. studies and reports from the ghana health service and non-state actors (ngos) have underscored the critical roles played by chws in eradicating the guinea worm in ghana. [ ] [ ] [ ] [ ] their roles included community mobilisation for awareness raising campaigns on the spread of the guinea worm, administration of palliative care, door-to-door distribution of drugs, referral to health centres for treatment, and distribution of water filters in communities. indeed, their role was so critical that both the national guinea worm eradication programme and some development partners (eg, carter center) have acknowledged it as being the most important factor in ghana's guinea worm eradication campaign. promotion of maternal and child health globally, chws have been acclaimed as having played a tremendous role in decreasing childhood illnesses and mortalities. notably, case management of childhood illness is one area where their contribution has been highly commended by the who and unicef. a study in ghana reported that chws were instrumental in establishing community health post, making home visits to provide healthcare services such as administration of antibiotics, oral rehydration solution and zinc to treat childhood illnesses such as pneumonia, diarrhoea and malaria. similar results have been reported by other studies globally. again in ghana, the role of tbas has been reported to double the number of women referred to clinics and hospitals for potentially life-saving care and support. indeed, in several communities in bolgatanga, kassena nankana and bawku west districts of ghana, oxfam has trained and evaluated the work of some tbas. the evidence from oxfam's work has shown positive results. in each of the communities where oxfam trained and worked with tbas, the number of women being referred by tbas to clinics and hospitals for potentially life-saving care doubled. maternal mortality has similarly reduced by %. further, between and , one of the authors ( jkg) was involved in a community-based pilot health project in communities in nadowli district, upper west region, ghana. this project was implemented by world vision ghana in partnership with ghana health services. the project trained cbsvs and tbas to perform a number of tasks, including recording births and deaths, and reporting disease outbreaks. several tbas also got trained to detect danger signs during pregnancy and labour and to make quick referral of pregnant women to health facilities to receive skilled care. the tbas were all provided basic consumables such as hand gloves, hand sanitisers, new packs of cutting blades and kerosene lanterns (to be used in the night when there is no electricity). the main aim of the project was to improve tbas' skills and resource them adequately to conduct normal deliveries, particularly in hard-to-reach rural communities. in mid- , an initial evaluation was done. the evaluation results showed that antenatal care attendance in some communities had increased twofold (ie, % in to % in ). qualitative interviews with women and tbas suggested that many tbas who received the training and essential consumables actively encouraged and referred pregnant women to healthcare facilities. also, among women who delivered at home with tbas, infections resulting from the use of bare hands and other unhygienic practices by tbas (such as the same blade being used to sever the umbilical cords of two babies) during labour were reported to have reduced. the women and tbas who participated in the interviews largely attributed the increase in the number of referrals to health facilities for skilled delivery and a reduction in infections during labour to the training tbas received and the supply of hand gloves, hand sanitisers and new blades. in fact, these positive results from ghana are supported by evidence from other low income contexts. [ ] [ ] [ ] [ ] [ ] notwithstanding these evidences, tbas' activities in maternal healthcare until now are still surrounded with controversies because the who official position only permits tbas to make referrals and not conduct home deliveries. however, based on this evidence from the upper east region and the fact that in ghana only % of births are attended to by a skilled attendant (defined here as a doctor, nurse or midwife), and % by tbas, we consider the who position on tbas as untenable in lmics such as ghana where the capacity to provide skilled and supervised delivery is limited. in other parts of the world especially in sub-saharan africa, the role of chws has been important in the fight against the spread of hiv/aids. - in ghana, the literature suggests that chws were recognised as a conduit to providing voluntary counselling and testing services. a cross-sectional survey conducted in northern ghana reported an overwhelming acceptance ( . %) of the use of lay health counsellors to provide community-based voluntary counselling and testing services. we noted, however, that only a few studies have covered the activities of chws in hiv/aids prevention and treatment in communities. our experience in working at the community level in ghana shows that chws are a key cadre of health staff working closely with chos and ngos in raising hiv/aids awareness, mobilising communities against stigma and discrimination and providing a culturally acceptable or a community-competent context for people living with hiv/aids. despite this, the district health information management system (dhims), a comprehensive database which reports on all aspects of services delivered by the ghana health service, does not report on chws' contribution to hiv/aids prevention and management. this suggests that even in contexts where their contribution is not in doubt, the healthcare system has not adequately documented or recognised their role. prior to the inception of the one million chw campaign (to which we return later), there was no national framework to guide the recruitment of chws in ghana. as a result, their recruitment was dependent on the community, the health programme, and the donor agency or development partner (ngo) involved. from the international literature and our experiences in ghana as well, chws are generally recruited from their own communities based on their level of acceptability in their respective communities, previous involvement in community-driven initiatives, high sense of dedication to duty and literacy (education) level. although these considerations are important, they are no doubt subjective and may affect the objective assessment and recruitment of chws. our experience in some communities shows that the lack of clearly defined recruitment criteria and strategy has often generated tensions among community members. indeed, some earlier studies have indicated how recruiting chws from local communities often served to generate tension and/or perpetuate gender inequalities. an important dimension regarding the recruitment of chws in ghana is the active role of ngos and other non-state actors. many ngos and other non-state actors who operate and/or implement parallel or vertical healthcare programmes in ghana often recruit parallel chws. in most cases, this parallel recruitment is often without regard for existing structures. from our experience, the ngos' style of engagement with chws can be problematic because recruiting chws without recourse to already existing structures can breed conflicts, duplication of efforts, lack of community participation and ownership of a particular health intervention and redundancies following the completion of the programmes of such organisations. comparable to the global situation, the scope of practice for chws lacks clarity and remains undefined in ghana. there has been a long-standing debate as to what exactly their roles should be and to what extent they are supposed to act in providing healthcare. according to a report by unicef, in south asia, one chw can provide healthcare services to about to households. generally, chws tend to provide more preventive and promotive healthcare, rather than curative. in other settings, the roles of chws have been observed to vary from community mobilisation for immunisation campaigns, health talks, first aid, creating awareness on disease control and health promotion to activities such as registration of births and deaths. in ghana, owing to the acute shortage of health personnel, chws' scope of practice has broadened beyond prevention and health promotional activities to encompass some curative care such as treatment for malaria and diarrhoea. generally, the scope of practice of chws in ghana varies widely, including serving as aids to community health officers, home visits, disease surveillance, maintaining environmental sanitation, nutrition education, home management of minor ailments like uncomplicated malaria, social mobilisation, and providing a limited range of reproductive and child health services. while this varied and flexible scope of practice may be a unique strength, it is therefore to be inferred that the lack of clarity on the operational mandates of chws in ghana has often undermined the effectiveness and efficiency of their roles in healthcare delivery at the community level. as observed by some researchers, a reasonable involvement of chws in limited activities has the tendency to enhance outcomes in community-based health interventions compared with an unlimited scope of practice. remuneration of chws is a controversial subject that has eluded consensus among stakeholders. internationally, the discourse is suggestive of the need to compensate their services in the form of a fee or in kind by the beneficiary communities. some other nonmonetary incentives such as providing bicycles, certificates or free healthcare to chws are also common. as a result, the who has underscored the need to pay chws reasonable wages in order to enhance their productivity, sustain community-driven interventions and reduce their attrition rates. [ ] [ ] [ ] the available literature has copiously cited the positive correlation between incentivising chws and lower rates of attrition. in ghana, chws are not remunerated by governments, and a spirit of volunteerism and altruism is rather emphasised. chws are required to draw satisfaction from community recognition, ability to gain skills and experience and the opportunity it presents to them to build social capital and access other job opportunities. this contradicts the who position and existing literature, which recommend the remuneration of chws. for instance, in the work of lehmann and sanders, the non-payment of chws under the premise that they were volunteers and offered services based on altruistic motives failed to motivate the chws to support the sustainability of community-based health interventions. our experience suggests that contrary to the government's view that chws activities should be inspired by altruism, chws usually have high expectations of rewards in the form of regular wages, stipends and some form of career opportunities to eventuate them into the health system. while chws are gaining increasing attention as important players in healthcare delivery in ghana and elsewhere, they are beset with multiple challenges. chws face capacity problems as they receive little or no formal training. one author noted this as a fundamental concern among chws as most of the experience they require for their job are gathered on the job. quite notably, the ghana health service recently attempted to address this challenge by developing training guides for some categories of chws. however, from our experience, there has been limited uptake of these training guides. we have also observed the inadequate supply of basic equipment such as wellington booths, bicycles, hand gloves and the first aid kit that some chws use to facilitate their work. neglect or inadequate recognition of chws is another fundamental challenge. as noted earlier, the absence of a policy directive on chws lends credence to our position. the current policy position of the government, which does not remunerate chws for contributing to deliver community health service, only exacerbates the dwindling enthusiasm of chws and the time they commit to their duties. this, to a large extent, affects negatively their productivity and retention. further, this has the potential to increase their attrition rates as has been reported in other settings to vary between . % and %. also, the attendant long-run effect of this situation is the high costs involved in selecting and training new chws as replacements. the inadequate recognition of chws has further led to the lack of a framework to regulate their practices as evidenced in the varying roles chws assume as espoused in earlier sections of this paper. the situation creates an inherent ambiguity and varying expectations of their roles which affects the optimum engagement of chws. in ghana, there are neither mechanisms nor a framework to regulate their practice or certify chws as having the requisite competencies to practice as in the case of other health professionals such as medical doctors, nurses or chns. to be able to attain standardisation and integration of the services of chws into the health system, a form of oversight is required. this may take the form of a regulatory or professional body which will provide some form of certification or licensing to duly recognise their competencies and standardise their practices. lack of effective supervision of chws is one of the notable problems chws face in ghana. our experiences in northern ghana suggest that laxity in the supervision of chws is mainly due to the already overstretched nature of the health system, which is attributable in part to the human resources for health crises. given that chws are now taking up more curative care activities in addition to the preventive-based care interventions, their activities should be supervised and coordinated closely to potentially optimise their productivity and improve health outcomes as evident in studies from other settings. also, a further step by the ministry of health (moh) to scale up the number of frontline staff to provide healthcare to the rural communities is the current partnership with the one million chw campaign project to introduce a new cadre of chws in ghana. this represents an important health policy direction in improving access and health outcomes of the rural populace in ghana. the one million chw campaign proposed to introduce a world-class cadre of chws to extend essential health services to household levels functioning as an integral component of the community health system. conceptually and based on the literature on chws, this category of chws will be an informal extension of the formal healthcare system with explicitly defined roles, training and remuneration to augment the delivery of healthcare. notably, this new cadre of chws differs substantially from the chws who are the subject of this paper except in their duties. while the policy issues of existing chws still remain to be addressed, the new programme only proposes to recognise the existing chws provided they will be useful in providing voluntary assistance to the formally remunerated new cadre of chws, and their continuous existence will be dependent on the particular health district. a justifiable policy question may therefore be why introduce a new cadre of chws to take up duties which were essentially carried out by a particular workforce but whose contribution has hitherto not been recognised and whose integration into the new programme has not been explicitly addressed. if such concerns are not addressed, there will most likely be challenges such as conflicting roles, tension between chws of the one million chw campaign and existing chws, lack of community participation and a threat to the sustainability of community-based health interventions. the preceding analysis points to a general policy deficit regarding chws in ghana, given the lack of a national framework to guide activities of chws such as recruitment, credentialling, scope of practice, remuneration, career development, performance management, supervisory mechanisms, integration into the formal health system, capacity development and logistical requirement and deployment. despite the active involvement of chws in the health system, they are invisible nationally and subnationally in terms of policies, strategies and budgeting. we therefore recommend the following immediate and long-term measures to forestall anticipated and existing challenges faced by chws: . the establishment or enactment of a national policy on chws which should define and outline the relevant aspects of their recruitment, credentialling, scope of practice, remuneration, career development, performance management, supervisory mechanisms, integration into the formal health system, capacity development and logistical requirement and deployment. . the establishment of a professional and/or regulatory body that will exercise oversight over chws by defining, monitoring or enforcing the standards and practice of chws in ghana including licensing or a form of certification. . the development of a long-term strategy that will see the gradual replacement or absorption of chws into the mainstream or formal health service in ghana. . that the proposed one million chw campaign project should incorporate an integration plan aimed at enlisting existing deserving chws who have a wealth of experience and skill to their credit and to further develop the capacities of those with inadequate skills to enable them to enlist and participate in the programme. . finally, policy steps should be taken to critically review the who position on tbas' roles in promoting maternal health. given the shortage of skilled birth attendants (sbas) in ghana and across sub-saharan africa as indicated by the latest who report on the 'state of the world's midwifery', it is clear that the ideal of ensuring skilled attendance at all births is not feasible or achievable in the short term. therefore, reasonably acceptable equity and efficiency arguments can be made for the building of working partnerships with and incorporation of tbas into the maternal healthcare system in contexts such as ghana where skilled maternal healthcare provision is acutely limited. indeed, widespread collaboration through policy support for the healthcare system to identify, train and enhance the skill sets of tbas is recommended. partnerships between tbas and sbas would also be critical for helping healthcare workers to learn from tbas how best to address the cultural needs and concerns of childbearing women. thus, even if the ghanaian health system were to train and deploy sufficient numbers of sbas to all parts of the country in the future, tbas could still play important roles in helping healthcare workers to provide culturally competent care. conclusion this relatively modest contribution by chws to healthcare delivery in ghana suggests the need for state and non-state actors alike to build better working partnerships with chws, provide financial remuneration, create career opportunities and other means of motivations to boost their productivity and sustain gains associated with their activities. in addition, there is the need for policy definition to harmonise the issues relating to chws in general. this is because chws play an indispensable role in delivering health to their communities and assume and actively play the role of health activists and advocates. the reported challenges faced by chws can be addressed through appropriate national policy articulation, and therefore development partners should work in partnership with the government of ghana to put in place these policies. handling editor douglas noble. contributors lb and ams conceived the study. lb, ams, pnt and jkg searched the literature. lb drafted the manuscript. all authors contributed substantially to the review of the manuscript for critical and intellectual content. all authors have read and approved the final version of the manuscript for publication. competing interests none declared. provenance and peer review not commissioned; externally peer reviewed. data sharing statement no additional data are available. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. see: http:// creativecommons.org/licenses/by-nc/ . / producing effective knowledge agents in a pluralistic environment: what future for community health workers? thirty years after alma-ata: a systematic review of the impact of community health workers delivering 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in ghana are large-scale volunteer community health worker programmes feasible? the case of sri lanka a community health worker intervention to address the social determinants of health through policy change community health workers " " for primary care providers and other stakeholders in health care systems frontline health workers coalition. a commitment to community health workers: improving data for decision making the state of the world's midwifery : delivering health, saving lives key: cord- -qbolo k authors: tadesse, trhas; alemu, tadesse; amogne, getasew; endazenaw, getabalew; mamo, ephrem title: predictors of coronavirus disease (covid- ) prevention practices using health belief model among employees in addis ababa, ethiopia, date: - - journal: infect drug resist doi: . /idr.s sha: doc_id: cord_uid: qbolo k background: ethiopia has taken strict preventive measures against covid- to control its spread, to protect citizens, and ensure their wellbeing. employee’s adherence to preventive measures is influenced by their knowledge, perceived susceptibility, severity, benefit, barrier, cues to action, and self-efficacy. therefore, this study investigated the predictors of covid- prevention practice using the health belief model among employees in addis ababa, ethiopia, . methods: multicentre cross-sectional study design was used. a total of employees selected by systematic sampling method were included in this study. data were collected using a pretested self-administered questionnaire. summary statistics of a given data for each variable were calculated. logistic regression model was used to measure the association between the outcome and the predictor variable. statistical significance was declared at p-value< . . direction and strength of association were expressed using or and % ci. results: from a total of respondents, ( . %) of them had poor covid- prevention practice. three hundred ninety-one ( . %), ( . %), ( . ), ( . %), ( . %) and ( . %) of the respondents had high perceived susceptibility, severity, benefit, barrier, cues to action and self-efficacy to covid- prevention practice, respectively. employees with a low level of perceived barriers were less likely to have a poor practice of covid- prevention compared to employees with a high level of perceived barrier [aor = . , % ci ( . , . )]. similarly, employees with low cues to action and employees with a low level of self-efficacy were practiced covid prevention measures to a lesser extent compared those with high cues to action and high level of self-efficacy [aor = . , % ci ( . , . )] and [aor = . , % ci ( . , . )], respectively. conclusion: the proportion of employees with poor covid- prevention was high. income, perceived barrier, cues to action, and self-efficacy were significantly associated with covid- prevention practice. the globe is facing an extremely bizarre time struggling to fight an enemy it never saw before; the novel coronavirus disease (covid)- . sars-cov- or covid- was first reported in december , as a cluster of acute respiratory illness in wuhan (pneumonia of unknown cause), hubei province, china, from where it spread rapidly around the globe involving more than countries. the world health organization (who) declared the outbreak a public health emergency of international concern (pheic) on january and a global pandemic on march . , as of april , more than . million cases have been reported across countries and territories, resulting in more than , deaths. about three-fourth ( , ) the people with covid- have recovered while about , of them are in a serious or critical condition. , there are now more than , confirmed cases of coronavirus infection across the continent africa, resulting in more than mortalities. similarly, about cases and death of covid- are reported in ethiopia as of april . covid- causes a range of respiratory symptoms including fever, fatigue, dry cough, and difficulty of breathing. it may result in serious complications like ards and death especially among elderly patients and patients with underlying medical conditions like heart disease, diabetes, hypertension, and asthma. a study done in china shows those patients with a severe form of covid developed ards and required icu admission and oxygen therapy. at this stage of the diseases, the mortality rate is high ( %). , for five decades, the health belief model (hbm) has been one of the most widely used conceptual frameworks in health behavior. the hbm has been used both to explain change and maintenance of health-related behaviors and as a guiding framework for health behavior intervention. it is now believed that people will take action to prevent or control ill-health conditions like covid- if they regard themselves as susceptible to the covid- ; if they believe it would have potentially serious consequences; if they believe that a course of action like stay home, keep social distance, wear face mask, etc available to them would help reduce either their susceptibility to the disease or the severity of the condition; and if they think that the likely barriers (or cost) of taking the actions outweighed by its benefits. given that health motivation is it's a central focus, the health belief model is an ideal option for addressing behavioral problems that evoke health concerns. the model has been tested repeatedly in western countries that it fits best for health behavior change studies as well as a planning model together with other health education and planning models, such as the precede-procede model. to date, a vaccine and effective treatment are not available for covid- . in a situation like this, basic hygiene principles and aggressive public health measures are virtually important for preventing the spread of the disease and hence reducing its impact in the community. therefore, this study was aimed at assessing predictors of covid- prevention practice among higher education employees in addis ababa ethiopia using a health belief model. the study was conducted to determine the predictors of covid- prevention practice among employees working in addis, ethiopia, may . addis ababa is the capital city of ethiopia with a population of around . million. addis ababa has administrative sub-cities and a total of kebeles. the study was done among employees selected from four organizations in addis ababa (ethiopian airlines, commercial bank of ethiopia, black lion hospital, and ethiopian telecommunication corporation). the study was done from may to june . a multicentered cross-sectional study design was used to assess predictors of covid- prevention practices using a health belief model among employees in addis ababa, ethiopia, . employees from the four stated organizations and who are willing to participate were included in this study. employees with hearing and visual impairment were excluded from this study. the sample size for the study was calculated using a single proportion formula by assuming % cl, % marginal error, and % proportion of covid- prevention practice. therefore, by adding a % non-response rate, the final sample size for this study was . the sample size was proportionally allocated to each of the four organizations. then, a systematic sampling method was used to select the study participants from each of the four organizations. according to the available submit your manuscript | www.dovepress.com infection and drug resistance : data during the study period, a total of active workers were available in the four selected organizations in addis ababa. hence, by dividing the total active employees during the study period ( ) with the total sample size ( ), (n/n), the sampling interval (k) of was obtained. the first employee was selected at random from each organization and consecutive participants were selected every seventh employee. participants were approached in their working area. variables covid- prevention practice was the dependent variable. demographic variables, knowledge about covid- , and the hbm constructs (perceived susceptibility, perceived severity, perceived benefit, perceived barrier, cues to action, and self-efficacy) were the independent variables. the questionnaire was developed by reviewing previous different literature conducted on prevention practice of covid- and in consultation with experts from different fields to check the relevance and make necessary changes according to the study requirements. the questions were modified according to the suggestions received from the expert panel and output from the pre-test. guidelines for layout, question design, formatting, and pretesting testing were followed. the questionnaire was used to gather employees' demographic data, knowledge about covid- and its prevention, health belief model constructs (perceived susceptibility, perceived severity, perceived benefit, perceived barrier, and cues to action self-efficacy), and practice of covid- prevention. spss version computer software package was used to analyze the data. the collected data were entered into spss and data cleaning was undertaken before data analysis. summary statistics like frequency, percent, mean, and standard deviation of a given data for each variable were calculated. a logistic regression model was used to measure the association between the outcome (covid- prevention practice) and the predictor variables (socio-demographic variables, knowledge, and the hbm constructs). statistical significance was declared at p-value< . . direction and strength of association was expressed using or and % ci. a preliminary phase was conducted to assess the validity and reliability of the questionnaire before its use. initially, three ethiopian experts in the field of epidemiology and research in ethiopian universities were asked to assess the degree to which items in the questionnaires were relevant and can correctly measure predictors of covid- prevention practice using the health belief model, and a correction was made accordingly. then, the questionnaire was pretested on participants who were excluded later from the study sample. data were used to assess internal consistency reliability using cronbach's alpha. the results showed adequate internal consistency reliability (with cronbach's alpha= . or perceived susceptibility, . for perceived severity, . for the perceived benefit, . for the perceived barrier, . for cues to action, and . for self-efficacy questions). approval and ethical clearance was obtained from the institution review board (irb) of universal medical and business college (umbc) which was in accordance with the principles embodied in the declaration of helsinki. official permission was also obtained from the principals of the four selected organizations before approaching the study participants. the objective and purpose of the study was clearly explained to the study subjects to obtain written informed consent before data collection. participants were also informed that they can discontinue or decline to participate in the study at any time. confidentiality of the information was maintained and the data were recorded anonymously throughout the study. knowledge of covid- : knowledge of covid- was measured using questions. each correct response was scored , and each incorrect response was scored . a total score of ≥ (≥ %) out of was considered as having good knowledge whereas a score < (< %) was considered as poor knowledge towards covid- and its prevention. covid- prevention practices: practice of covid- prevention was measured using eleven questions. each correct response in the practice category was scored , and infection and drug resistance : submit your manuscript | www.dovepress.com dovepress each incorrect response was scored . a total score of ≥ (≥ %) out of eleven was considered as having good practice whereas a score < (< %) was considered as having a poor practice of covid- prevention. perceived susceptibility: one's belief regarding the chance of getting covid- . respondents will be asked eight questions (eg i am not afraid of getting coronavirus infection) to describe their level of agreement in a five-scale response format from "strongly disagree" to "strongly agree". the -point likert scale response options, scored from to , were strongly disagree, disagree, neutral, agree, and strongly agree. subscale scores were obtained by summing item scores and dividing by the total number of items. if it is above or equal to the average score, it was indicative of high perceived susceptibility. perceived severity: one's belief of how serious covid- and its squeal are. respondents were asked six questions (eg becoming corona virus-infected is the worst thing that could happen to me) to describe their level of agreement in a five scale response format from "strongly disagree" to "strongly agree". the -point likert scale response options, scored from to , were strongly disagree, disagree, neutral, agree, and strongly agree. subscale scores were obtained by summing item scores and dividing by the total number of items. if it is above or equal to the average score, it was indicative of high perceived severity. perceived benefit: one's beliefs in the efficacy of covid- prevention practice like hand washing, social distancing, etc. to reduce the risk of getting covid- . respondents were asked questions (eg washing hands frequently with soap and water or using alcohol-based hand rub kills the virus that causes covid- ) to describe their level of agreement in a five-scale response format from "strongly disagree" to "strongly agree". the -point likert scale response options, scored from to , were strongly disagree, disagree, neutral, agree, and strongly agree. subscale scores were obtained by summing item scores and dividing by the total number of items. if it is above or equal to the average score, it was indicative of a high perceived benefit. perceived barrier: one's belief about the tangible and psychological costs of practicing covid- prevention mechanisms like staying at home. respondents were asked six questions (eg face mask is hard to get) to describe their level of agreement in a five-scale response format from "strongly disagree" to "strongly agree". the -point likert scale response options, scored from to , were strongly disagree, disagree, neutral, agree, and strongly agree. subscale scores were obtained by summing item scores and dividing it by the total number of items. if it is above or equal to the average score, it was indicative of a low level of perceived barrier. cues to action: strategies to activate one's "readiness" to use covid- prevention practices. based on prior research (wilson et al, ), a -item yes/no scale was used to assess participant's exposure to cues that could influence them to engage in covid- practice. the scale was developed. typical items as follows: "do you know someone with covid- ?" the sum of the score ranged from to ; higher scores indicated exposure to more covid- information. scale score was obtained by summing item scores and dividing by the total number of items. self-efficacy: one's confidence in one's ability to use or apply prevention of covid- practices recommended by who in a different situation. respondents were asked five questions (eg feel confident that i could talk to any person to using a face mask) to describe their level of agreement in a five-scale response format from "strongly disagree" to "strongly agree". the -point likert scale response options, scored from to , were strongly disagree, disagree, neutral, agree, and strongly agree. subscale scores were obtained by summing item scores and dividing by the total number of items. if it was above or equal to the average score, it was indicative of a high level of self-efficacy. a total of employees working in four organizations in addis ababa were included in this study. more than half of the study subjects ( . %) were in the age category of - years with a mean ± sd of . ± . years. the majority of the respondent ( . %) were males and more than half ( . %) of them were single. the majority ( . %) and ( . %) of them were degree holders by educational level and earn a monthly income of - birr, respectively. most ( . %) of them were bank workers, while ( . %) of them were health workers ( table ) . of the total of respondents, ( . %) of them had poor knowledge about covid- ( figure ). all of the respondents heard about the disease. more than half ( . %) of them were not aware of the call center service number to seek information about covid- and half submit your manuscript | www.dovepress.com infection and drug resistance : ( . %) of the employees were aware of the main symptoms of covid- like fever, dry cough, and difficulty of breathing. two hundred ninety-seven ( . %) of them believed that persons infected with covid- , but has no symptoms cannot transmit the virus to others. close to half ( . %) of them said children and young adults do not need to take measures to prevent covid- , and people who have contact with someone infected with the covid- should be immediately quarantined. only ( . %) of them said the length of quarantine of people who have contact with covid- cases is days ( table ) . the major sources of information about covid- for the study subjects were government media (tv/radio) ( . %), social media ( . %), local sources like posters, banners ( . %), national sources (moh/ephi) ( . %) and private medias tv/radio ( . %) (figure ). bivariate and multivariate logistic regression models were carried out to determine the factors affecting the employees' knowledge of covid- . only variables with a p-value ≤ . (age, level of education, occupation, income) were included in the multivariate regression. after adjusting for possible confounding factors with multivariate regression; age, level of education, and income were significantly associated with knowledge about covid- with a p-value < . . employees in the age category of - years were . times [aor = . , % ci ( . , . )] more likely to have a poor level of knowledge about covid- compared to employees whose age was greater than years. similarly, employees with an educational level of the certificate were . times [aor = . , % ci ( . , . )] more likely to have a poor level of knowledge about covid- than employees with an educational level of degree an above. employees with a monthly income of - , birr were less likely to have a poor level of knowledge about covid- ( table ) . three hundred ninety-one ( . %) of the respondents had high perceived susceptibility to covid- while the rest ( . %) had low perceived susceptibility to coronavirus infection with a mean score ± sd of . ± . and a median value of . concerning the perceived severity of the disease, ( . %) of the respondents had high perceived severity to coronavirus infection while the rest ( . %) had low perceived severity and the mean score for perceived severity was . with a standard deviation ± . and median value . concerning the third component of the health belief model, half ( . %) of the respondents had low perceptions about the benefit of coronavirus infection prevention practice. but ( . %) of the participants had high perceived benefit with a mean ± sd score of . ± . with a median value of . three hundred twenty-five ( . %) of the respondents were exposed to low triggering factors for coronavirus infection prevention with a mean ± sd score of . ± . and median value . four hundred ninety-seven ( . %) of the respondents had a high perceived barrier and the rest ( . %) of the participants had low perceived barrier with a mean ± sd score of . ± . with a median value of . about ( . %) had low selfefficacy towards coronavirus infection prevention with a mean ± sd score of . ± . with and a median value of (table ) . of the total of respondents, ( . %) of them had a poor practice of covid- prevention. more than half . % of them did not clean surfaces. only . % of them cover their mouth and nose while sneezing and coughing while . % of them disposed used tissues properly after coughing and sneezing. the majority of . % of them washed their hands frequently with soap and water for seconds and . % of them cleaned their hands with alcohol-based sanitizer if water is not available. more than half . % of them wear masks in public areas and none of them kept their distance. more than two-thirds of . % of them avoided groups and all of them stayed at home if they feel sick (figures and ). a bivariate and a multivariate logistic regression model was carried out to determine the factors affecting the employees' knowledge of covid- . only variables with a p-value ≤ . (sex, knowledge, perceived severity) were included in the multivariate regression. after adjusting for possible confounding factors with multivariate regression; income, perceived barrier, cues to action, and self-efficacy were significantly associated with prevention practice of covid- with a p-value < . . employees with a monthly income of - , birr and - , birr were more likely to practice the prevention of covid- compared to employees with a monthly income of ≥ , birr [aor = . , % ci ( . , . )] and [aor = . , ci ( . , . )], respectively. employees with low level of perceived barriers were less likely to have a poor practice of covid- prevention compared to employees with a high level of perceived barrier [aor = . , % ci ( . , . )]. similarly, employees with low cues to action and employees with a low level of self-efficacy were practiced covid prevention measures to a lesser extent compared those with high cues to action and high level table ). covid- is an emerging infectious disease that poses a significant threat to public health. given the severe threats imposed by covid- and the lack of a covid- vaccine, preventive measures play a vital role in decreasing infection rates and halting the spread of the disease. this indicates the necessity of employees to practice the preventive and control measures, which is affected by socio-demographic characteristics, level of knowledge, perceived susceptibility, severity, benefit, barrier, cues to action, and self-efficacy. therefore, this study was the first study to assess the predictors of coronavirus infection prevention practice among employees of addis ababa, ethiopia using the health belief model. in this study, the level of covid- prevention practice was ( . %). this was similar to a study conducted in residents of ethiopia. however, this was lower when compared to the previous study done among health professionals in ethiopia which were %, , and with the study conducted among the high-risk group of addis ababa ethiopia which was % with the study conducted in the kingdom of saudi arabia. and with the study conducted in hong kong which was % of the participants reported good health performance for covid- . this discrepancy might be due to the difference in the study population. a perceived barrier is one of the components of hbm that deals with the perception of barriers that do not allow the performance of coronavirus infection prevention (ie availability and accessibility of water, home environment, and the availability of electricity and internet connection). the present study finds out that employees with low level of perceived barriers were less likely to have a poor practice of covid- prevention compared to employees with a high level of perceived barrier [aor = . , % ci ( . , . )]. this might be due to the finding proportion of households with soap and water for handwashing was % and current levels of access to water and hand-washing facilities, and characteristics of the home environment are not conducive for effective implementation of basic prevention measures, including social distancing and limited access to electricity and internet connection discourages work from home. self-efficacy is one of the components of hbm that refers to the level of a person's confidence in his or her ability to successfully perform the prevention mechanism of covid- . the current study identified that employees with low cues to action and employees with a low level of self-efficacy were practice covid prevention measures to a lesser extent compared with those with high cues to action and high level of cues to action [aor = . , % ci ( . , . )] and [aor = . , % ci ( . , . )], respectively. this was in line with the study conducted in turkish adults and with the study conducted in iran among hospital staff. individuals who believe they are at low risk of developing a covid- are more likely to engage in unhealthy, or risky, behaviors like not wearing a face mask, unable to keep social distancing, etc., and the combination of perceived severity and perceived susceptibility is referred to as perceived threat which depend on knowledge about the covid- situation. the hbm predicts that higher perceived threat leads to a higher likelihood of engagement in health-promoting behaviors like keeping social distancing, properly wearing a face mask, hand hygiene, etc. but the current study failed to show the significant association between covid- prevention practice and perceived severity and perceived susceptibility. this might be due to the knowledge gap that was found among the employees towards the covid- situation was %. a study conducted in sudan to determine the sudanese perceptions of covid- using the health belief model showed that low perceived susceptibility (beliefs about the likelihood of getting covid- ) and severity (beliefs about the seriousness of contracting covid- , including consequences) was % and %, respectively. this is slightly higher compared to the current study, which was . % of the employee had low perceived susceptibility. but the perceived severity was slightly lower which . % of the employees had low perceived severity. this difference might be due to the difference in the study area.and the source of the population. in the current study of a total of respondents, ( . %) of them had good knowledge about covid- . this was higher when it compared with the study that was done in ethiopia which was % of the participants had good knowledge on transmission of covid- and with the study conducted in india which was % of the participants have good perceived knowledge for preventive measures. this study has some limitations. one of the limitations is bias occurred as a result of the study design (crosssectional) since the study took the information at specified time-points and cause and effect association cannot be studied. different mechanisms were used to reduce potential bias in the study. in addition to this, a lack of sufficient similar study limited comparison to this study finding with other studies. however, identifying knowledge gaps, perceived susceptibility, severity, benefit, barrier, cues to action, self-efficacy, and practice can be used to develop effective interventions and establish baseline levels to set priorities for program managers. this study examined the predictors of covid- prevention practice using the health belief model among employees of addis ababa, ethiopia. a significant number of employees had poor knowledge about covid- and its prevention. the proportion of poor prevention practice of covid- was also high. income, perceived barrier, cues to action, and self-efficacy were significantly associated with the prevention practice of covid- with a p-value< . . hence, policymakers and other concerned bodies should focus on those areas to improve the prevention practice of covid- . consent to publish is not applicable for this manuscript because there are no individual data 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covid- : . applying the health belief model public perception and preparedness for the pandemic covid : a health belief model approach clinical. epidemiol glob health our heartfelt thanks go to universal medical and business college for funding the study. the researchers also wish to express their gratitude to the study subjects and to all those who lent their hands for the successful completion of this research. all authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis, and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. this research was funded by universal medical college but has no other role in the manuscript. the authors affirm that there is no conflict of interest concerning the publication of this manuscript. infection and drug resistance is an international, peer-reviewed openaccess journal that focuses on the optimal treatment of infection (bacterial, fungal and viral) and the development and institution of preventive strategies to minimize the development and spread of resistance. the journal is specifically concerned with the epidemiology of antibiotic resistance and the mechanisms of resistance development and diffusion in both hospitals and the community. the manuscript management system is completely online and includes a very quick and fair peerreview system, which is all easy to use. visit http://www.dovepress.com/ testimonials.php to read real quotes from published authors. key: cord- -f i ufs authors: aith, fernando; castilla martínez, midalys; cho, malhi; dussault, gilles; harris, matthew; padilla, mónica; murphy, gail tomblin; tomlin, paul; valderas, josé m title: is covid- a turning point for the health workforce? date: - - journal: rev panam salud publica doi: . /rpsp. . sha: doc_id: cord_uid: f i ufs nan in , the united nations issued the agenda for sustainable development goals,( ) which highlighted the need to ensure healthy lives and promote well-being for all across the lifespan. goal aims to make sure everyone has access to health and health coverage and, in , the united nations general assembly adopted the political declaration of the highlevel meeting on universal health coverage reaffirming that "health is a precondition for and an outcome and indicator of the social, economic and environmental dimensions of sustainable development".( ) the high-level commission on health employment and economic growth identified that investments in the health and social workforce can spur inclusive economic growth. ( ) achieving goal requires health services that are accessible (available and affordable), culturally acceptable and that provide quality care by well-trained health workers. the world health organization (who), however, estimates a worldwide projected shortfall of million health workers by , mostly in low-and lower-middle income countries. countries at all levels of socioeconomic development face -to varying degrees-difficulties in employment, deployment, retention, and performance of their workforce due to chronic underinvestment in education and training of health workers and the mismatch between education and employment strategies in relation to health systems and population needs. ( ) the pan american health organization/world health organization (paho/who) has a long history of contribution to the development of human resources for health in the region of the americas through pioneering actions such as calling for regional action to implement policies for the development of human resources in health in areas such as regulation, education, professional practice, work, and specialized migration, as well as the creation of observatories and the virtual campus for public health. its "strategy on human resources for universal access to health and universal health coverage" ( ) offers guidance to countries to progress towards improving the availability, accessibility and quality of their health workforce. evidence-informed workforce policies are of critical importance in support of strong and resilient health care systems. in alignment with the priorities set by the strategy, a special issue of the pan american journal of public health on "human resources for universal health" was planned at the end of as a contribution to implementing the vision of the astana declaration on primary health care ( ) , with the goal of stimulating research on three topics: governance, capacity building, and education and training of health workers. research can produce actionable evidence for governance on how decision-making, planning, regulation, inter-sectoral and inter-organizational coordination, leadership and management mechanisms are conducive to the design and implementation of workforce policies that respond to the rapidly changing needs of the populations in equitable manner. there is equity in access when all members of a population have the same level and quality of access to health workers, according to need, irrespective of their capacity to pay and without any form of discrimination (social status, ethnic origins, religion, sexual orientation, etc.). access to health workers is equitable when it is modulated in function of the importance of the need, e.g. urgency, or the severity of the health problem, and when health workers provide the same quality of service to all people who need it. as regards to capacity building, it is critical to establish the technical and leadership skills that are available at all levels of the policy development and management of the workforce, and to create and sustain supportive management that motivates and enables workers to provide services at the highest level of quality. we also need more clarity about how to align education and training programs with the needs of health services, so that they this is an open access article distributed under the terms of the creative commons attribution-noncommercial-noderivs . igo license, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited. no modifications or commercial use of this article are permitted. in any reproduction of this article there should not be any suggestion that paho or this article endorse any specific organization or products. the use of the paho logo is not permitted. this notice should be preserved along with the article's original url. then came the covid- pandemic! in a matter of weeks, even days, it did more than all past advocacy efforts to highlight in real time the critical role of health workers, vital to respond to emergencies and disasters. all of a sudden, physicians, nurses, auxiliaries, ambulance staff, and all support personnel became heroes. however, it soon became clear that the commitment demonstrated by health workers was not enough to respond adequately to the crisis. numerous deficiencies in the management of the health workforce became visible to all, from users of services to political decision-makers. in addition to insufficient numbers of workers overall, the crisis revealed inequities of access due to shortages in certain regions, typically rural, remote and poor. in many countries of the region, this is compounded by the underutilization of the skills of diverse occupational groups, like nurses and pharmacists, and by an inefficient composition of the workforce, with low ratios of nurses ( ) and other personnel to physicians, and of generalists to specialists. it also threw light on the often difficult working conditions of health staff, their low remuneration, and the gaps between what is necessary to provide a good response to the needs of the sick and what is at their disposal. it showed the need for upskilling personnel working in intensive care units, in homes for the aged and the disabled, and physicians and nurses needed training in the use of telemedicine. even if this was not news to students of health labor markets, it was a wake-up call for policy-makers and the public. the recognition of these problems is a prerequisite to the introduction of change. so what needs to be done given that covid- has made this problem so obvious? this is where research finds its purpose and applicability and where sound scientific evidence can make a contribution to informing policy-making. the workforce situation needs to be well documented, the causes of its weaknesses understood, and above all, the options to intervene, what works, what does not work, all need to be identified. some important questions remain: will the crisis be a catalyst of policy change? will governments spend more on health services and their workers? spending on the health workforce, if done well, is a good investment. the challenge is for countries to develop policies that generate efficiency and effectiveness; planning a more rational balance between community health workers, nurses and physicians; expanding the scope of practice to make the full potential of each cadre available; systematic regulation of education and of practice; and the creation of enabling work environments. the result will not only be better health indicators, but also economic growth.( ) it could also avoid or help mitigate the disastrous economic consequences that the world has experienced as a result of the public health crisis. the publication by the pan american journal of public health of this special issue on human resources for universal health seems timely as it coincides with the international year of the nurse and the midwife and with the landmark publication of the state of the world's nursing report. ( ) this issue presents research on the most important resource of health services -its workers. we hope the articles provide valuable experience and evidence that will inform decisions and health policies in the region going forward and provide impetus to the implementation of the declaration of astana. united nations, general assembly. political declaration of the highlevel meeting on universal health coverage. resolution a/res/ / world health organization. working for health and growth: investing in the health workforce world health organization. health workforce pan american health organization. strategy on human resources for universal access to health and universal health coverage world health organization and the united nations children´s fund (unicef). a vision for primary health care in the st century: towards universal health coverage and the sustainable development goals distribución de la fuerza de trabajo en enfermería en la región de las américas who commission on macroeconomics and health. macroeconomics and health: investing in health for economic development / report of the commission on macroeconomics and health. geneva: world health organization state of the world's nursing : investing in education, jobs and leadership. geneva: world health organization the pan american journal of public health recognizes with appreciation the contributions of the members of the editorial committee and authors of this overview. their dedication to this issue on human resources for universal health helped make the manuscripts more interesting and more useful to our readers and all others who work to improve the health of the peoples of the americas. key: cord- - jzkdu authors: bickman, leonard title: improving mental health services: a -year journey from randomized experiments to artificial intelligence and precision mental health date: - - journal: adm policy ment health doi: . /s - - - sha: doc_id: cord_uid: jzkdu this conceptual paper describes the current state of mental health services, identifies critical problems, and suggests how to solve them. i focus on the potential contributions of artificial intelligence and precision mental health to improving mental health services. toward that end, i draw upon my own research, which has changed over the last half century, to highlight the need to transform the way we conduct mental health services research. i identify exemplars from the emerging literature on artificial intelligence and precision approaches to treatment in which there is an attempt to personalize or fit the treatment to the client in order to produce more effective interventions. in , i was writing my first graduate paper at columbia university on curing schizophrenia using sarnoff mednick's learning theory. i was not very modest even as a first-year graduate student! but i was puzzled as to how to develop and evaluate a cure. then, as now, the predominant research design was the randomized experiment or randomized clinical trial (rct). it was clear that simply describing, let alone manipulating, the relevant characteristics of this one disorder and promising treatments would require hundreds of variables. developing an effective treatment would take what seemed to me an incalculable number of randomized trials. how could we complete all the randomized experiments needed? how many different outcomes should we measure? how could we learn to improve treatment? how should we consider individual differences in these group comparisons? i am sure i was not insightful enough to think of all these questions back then, but i know i felt frustrated and stymied by our methodological approach to answering these questions. but i had to finish the paper, so i relegated these and similar questions to the list of universal imponderables such as why i exist. in fact, i became a committed experimentalist, and i dealt with the limitations of experiments by recognizing their restrictions and abiding by the principle "for determining causality, in many but not all circumstances, the randomized design is the worst form of design except all the others that have been tried " (bickman and reich , pp. - ) . for the much of my career, i was a committed proponent of the rct as the best approach to understanding causal relationships (bickman ) . however, as some of my writing indicates, it was a commitment with reservations. i did not see a plausible alternative or complement to rcts until recently, when i began to read about artificial intelligence (ai) and precision medicine in . the potential solution to my quandary did not crystallize until , when i collaborated with aaron lyons and miranda wolpert on a paper on what we called "precision mental health" (bickman et al. ) . with the development of ai and its application in precision medicine, i now believe that ai is another approach that we may be able to use to understand, predict, and influence human behavior. while not necessarily a substitute for rcts in efforts to improve mental health services, i believe that ai provides an exciting alternative to rcts or an adjunct to them. while i use precision medicine and precision mental health interchangeably, i will differentiate them later in this paper. toward that end, i focus much of this paper on the role of ai and precision medicine as a critical movement in the field with great potential to inform the next generation of research. before proposing such solutions, i first describe the challenges currently faced by mental health services, using examples drawn almost entirely from studies of children and youth, the area in which i have conducted most of my research. i describe five principal causes of this failure, which i attribute primarily, but not solely, to methodological limitations of rcts. lastly, i make the case for why i think ai and the parallel movement of precision medicine embody approaches that are needed to augment, but probably not replace, our current research and development efforts in the field of mental health services. i then discuss how ai and precision mental health can help inform the path forward, with a focus on similar problems manifested in mental health services for adults. these problems, i believe, make it clear that we need to consider alternatives to our predominant research approach to improving services. importantly, most of the research on ai and precision medicine i cite deals with adults, as there is little research in this area on children and youth. i am assuming that we can generalize from one literature to the other, but i anticipate that there many exceptions to this assumption. according to some estimates, more than half ( . %) of adults with a mental illness receive no treatment (mental health in america ) . less than half of adolescents with psychiatric disorders receive any kind of treatment (costello et al. ) . over % of youth with major depression do not receive any mental health treatment (mental health in america ). several other relevant facts when it comes to youth illustrate the problem of their access to services. hodgkinson et al. ( ) have documented that less than % of children in poverty receive needed services. these authors also showed that there is less access to services for minorities and rural families. when it comes to the educational system, mental health in america ( ) estimated that less than % of students have an individual education plan (iep), which students need to access school-supported services, even though studies have shown that a much larger percentage of students need those services. access is even more severely limited in in low-and middle-income countries (esponda et al. ). very few clients receive effective evidence-based quality mental health services that have been shown to be effective in laboratory-based research (garland et al. ; gyani et al. ). moreover, research shows that even when they do receive care that is labeled evidence-based, it is not implemented with sufficient fidelity to be considered evidence-based (park et al. ) . no matter how effective evidence-based treatments are in the laboratory, it is very clear that they lose much of their effectiveness when implemented in the real world (weisz et al. (weisz et al. , . research reviews demonstrate that services that are typically provided outside the laboratory lack substantial evidence of effectiveness. there are two factors that account for this lack of effectiveness. as noted above, evidencebased services are usually not implemented with sufficient fidelity to replicate the effectiveness found in the laboratory. more fundamentally, it is argued here that even evidencebased services may not be sufficiently effective as currently conceptualized. a review of published studies on school-based health centers found that while these services increased access, the review could not determine whether services were effective because the research was of such poor quality (bains and diallo ) . a meta-analysis of studies of mental health interventions implemented by school personnel found small to medium effect sizes, but only % of the services were provided by school counselors or mental health workers (sanchez et al. ) . a cochrane review concluded, "we do not know whether psychological therapy, antidepressant medication or a combination of the two is most effective to treat depressive disorders in children and adolescents" (cox et al. , p. ) . another meta-analysis of studies on school-based interventions delivered by teachers showed a small effect for internalizing behaviors but no effect on externalizing ones (franklin et al. a) . similarly, a meta-analysis of meta-analyses of universal prevention programs targeting school-age youth showed a great deal of variability with effect sizes from to . standard deviations depending on type of program and targeted outcome (tanner-smith et al. ) . a review of rcts found no compelling evidence to support any one psychosocial treatment over another for people with serious mental illnesses (hunt et al. ) . a systematic review and meta-analysis of conduct disorder interventions concluded that they have a small positive effect, but there was no evidence of any differential effectiveness by type of treatment (bakker et al. ) . fonagy and allison ( ) conclude, "the demand for a reboot of psychological therapies is unequivocal simply because of the disappointing lack of progress in the outcomes achieved by the best evidence-based interventions" (p. ). probably the most discouraging evidence was identified by weisz et al. ( ) on the basis of a review of rcts over a -year period. they found that the mean effect size for treatment did not improve significantly for anxiety and adhd and decreased significantly for depression and conduct problems. the authors conclude: in sum, there were strikingly few exceptions to the general pattern that treatment effects were either unchanged or declining across the decades for each of the target problems. one possible implication is that the research strategy used over the past decades, the treatment approaches investigated, or both, may not be ideal for generating incremental benefit over time. (p. ) there is a need-indeed, an urgent need-to change course, because our traditional approaches to services appear not to be working. however, we might be expecting too much from therapy. in an innovative approach to examining the effectiveness of psychotherapy for youth, jones et al. ( ) subjected rcts to a mathematical simulation model that estimated that even if therapy was perfectly implemented, the effect size would be a modest . . they concluded that improving the quality of existing psychotherapy will not result in much better outcomes. they also noted that ai may help us understand why some therapies are more effective than others. they suggested that the impact of therapy is limited because a plethora of other factors influence mental health, especially given that therapy typically lasts only one hour a week out of + waking hours. they also indicated that other factors that have not been included in typical therapies, such as individualizing or personalizing treatment, may increase the effectiveness of treatment. i am not alone in signaling concern about the state of mental health services. for example, other respected scholars in children's services research have also raised concerns about the quality and effectiveness of children's services. weisz and his colleagues (marchette and weisz ; ng and weisz ) described several factors that contribute to the problems identified above. these included a mismatch between empirically supported treatments and mental health care in the real world, the lack of personalized interventions, and the absence of transdiagnostic treatment approaches. it is important to acknowledge the pioneering work of sales and her colleagues, who identified the need and tested approaches to individualizing assessment and monitoring clients (alves et al. (alves et al. , elliott et al. ; alves , ; sales et al. sales et al. , . we need not only to appreciate the relevance of this work but also to integrate it with new artificial intelligence approaches described later in this paper. i am not concluding from such evidence that all mental health services are ineffective. this brief summary of the state of our services can be perceived in terms of a glass half full or half empty. in other words, there is good evidence that some services are effective under particular, but yet unspecified, conditions. however, i do not believe that the level of effectiveness is sufficient. moreover, we are not getting better at improving service effectiveness by following our traditional approach to program development, implementation, research, and program evaluation. while it is unlikely that the social and behavioral sciences will experience a major breakthrough in discovering how to "cure" mental illness, similar to those often found in the physical or biological sciences, i am arguing in this paper that we must increase our research efforts using alternative approaches to produce more effective services. a large part of this paper, therefore, is devoted to exploring what has been also called a precision approach to treatment in which there is an attempt to personalize treatment or fit treatment to the client in order to produce more effective interventions. in some of my earliest work in mental health, i identified the field's focus on system-level factors rather than on treatment effectiveness as one cause of the problems with mental health services. the most popular and well-funded approach to mental health services in the s and s, which continues even today, is called a system or continuum of care (bickman (bickman , bickman et al. b; bryant and bickman ) . this approach correctly recognized the problems with the practice of providing services that were limited to outpatient and hospitalization only, which was very common at that time. moreover, these traditional services did not recognize the importance of the role played by youth and families in the delivery of mental services. to remedy these important problems, advocates for children's mental health conceptualized that a system of care was needed, in which a key ingredient was a managed continuum of care with different levels or intensiveness of services to better meet the needs of children and youth (stroul and friedman ) . this continuum of care is a key component of a system of care. however, i believe that in actuality, these different levels of care simply represent different locations of treatment and restrictiveness (e.g., inpatient vs. outpatient care) and did not necessarily reflect a gradation of intensity of treatment. a system of care is not a specific type of program, but an approach or philosophy that combines a wide range of services and supports for these services with a set of guiding principles and core values. services and supports are supposed to be provided within these core values, which include the importance of services that are community-based, family-focused, youth-oriented, in the least restrictive environment, and culturally and linguistically proficient. system-level interventions focus on access and coordination of services and organizations and not on the effectiveness of the treatments that are provided. it appeared that the advocates of systems of care assumed that services were effective and that what was needed was to organize them better at the systems level. although proponents of systems of care indicated that they highly valued individualized treatment, especially in what were called wraparound services, there was no distinct and systematic way that individualization was operationalized or evaluated. moreover, there was not sufficient evidence that supported the assumption that wraparound services produced better clinical outcomes (bickman et al. ; stambaugh et al. ) . a key component of the system is providing different levels of care that include hospitalization, group homes, and outpatient services, but there is little evidence that clinicians can reliably assign children to what they consider the appropriate level of care (bickman et al. a ). my earliest effort in mental health services research was based on a chance encounter that led to the largest study ever conducted in the field of child and youth mental health services. i was asked by a friend to see if i could help a person whom i did not know to plan an evaluation of a new way to deliver services. this led to a project that cost about $ million to implement and evaluate. we evaluated a new system of care that was being implemented at fort bragg, a major u.s. army post in north carolina. we used a quasi-experimental design because the army would not allow us to conduct a rct; however, we were able to control for many variables by using two similar army posts as controls (bickman ; bickman et al. ) . the availability of sufficient resources allowed me to measure aspects of the program that were not commonly measured at that time, such as cost and family empowerment. with additional funding that i received from a competitive grant from the national institute of mental health (nimh) and additional follow-up funding from the army, we were able to do a cost-effectiveness analysis (foster and bickman ) , measure family outcomes (heflinger and bickman ) , and develop a new battery of mental health symptoms and functioning (bickman and athay ). in addition, we competed successfully for an additional nimh grant to evaluate another system of care in a civilian population using a rct (bickman et al. a, b) and a study of a wraparound services that was methodologically limited because of sponsor restrictions (bickman et al. ) . i concluded from this massive and concentrated effort that systems of care (including the continuum of care) were able to influence system-level variables, such as access, cost, and coordination, but that there was not sufficient evidence to support the conclusion that it produced better mental health outcomes for children or families or that it reduced costs per client . this conclusion was not accepted by the advocates for systems of care or the mental health provider community more generally. moreover, i became persona non grata among the proponents of systems of care. while the methodologists who were asked to critique on the fort bragg study saw it as an important but not flawless study (e.g., sechrest and walsh ; weisz et al. ) that should lead to new research (hoagwood ) , most advocates thought it to be a well-done evaluation but of very limited generalizability (behar ). it is important to note that the system of care approach, almost years later, remains the major child and youth program funded by the substance abuse and mental health services administration's (samhsa) center for mental health services (cmhs) to the tune of about a billion dollars in funding since the system of care program's inception in . there have been many evaluations funded as part of the samhsa program that show some positive results (e.g., holden et al. ), but, in my opinion, they are methodologically weak and, in some cases, not clearly independent. systems of care are still considered by samhsa's center for mental health services to be the premier child and adolescent program worthy of widespread diffusion and funding (substance abuse and mental health services administration ), regardless of what i believe is the weak scientific support. this large investment of capital should be considered a significant opportunity cost that has siphoned off funds and attention from more basic concerns such as effectiveness of services. sadly, based on my unsuccessful efforts to encourage change as a member of the cmhs national advisory council ( - ), i am not optimistic that there will be any modification of support for this program or shift of funding to more critical issues that are identified in this paper. in the following section, i consider some of the problems that have contributed to the current status of mental health services. my assessment of current services led me to categorize the previously described deficiencies into the five following related problem groups. the problems with the validity of diagnoses have existed for as long as we have had systems of diagnoses. while a diagnosis provides some basis for tying treatment to individual case characteristics, its major contribution is providing a payment system for reimbursement for services. research has shown that external factors such as insurance influence the diagnosis given, and the diagnosis located in electronic health records is influenced by commercial interests (perkins et al. ; taitsman et al. ) . other studies have demonstrated that the diagnosis of depression alone is not sufficient for treatment selection; additional information is required (iniesta et al. ). moreover, others have shown that diagnostic categories overlap and are not mutually exclusive (bickman et al. c) . in practice, medication is prescribed according to symptoms and not diagnosis (waszczuk et al. ) . in their thematic analysis of selected chapters of the diagnostic and statistical manual of mental disorders (dsm- ), allsopp et al. ( ) examined the heterogeneous nature of categories within the dsm- . they showed how this heterogeneity is expressed across diagnostic criteria, and explained its consequences for clinicians, clients, and the diagnostic model. the authors concluded that "a pragmatic approach to psychiatric assessment, allowing for recognition of individual experience, may therefore be a more effective way of understanding distress than maintaining commitment to a disingenuous categorical system" (p. ). moreover, in an interview, allsop stated: although diagnostic labels create the illusion of an explanation, they are scientifically meaningless and can create stigma and prejudice. i hope these findings will encourage mental health professionals to think beyond diagnoses and consider other explanations of mental distress, such as trauma and other adverse life experiences. (neuroscience news , para. ) finally, a putative solution to this muddle is nimh's research domain criteria initiative (rdoc) diagnostic guide. rdoc is not designed to be a replacement of current systems but serves as a research tool for guiding research on mental disorders systems. however, it has been criticized on several grounds. for example, heckers ( ) states, "it is not clear how the new domains of the rdoc matrix map on to the current dimensions of psychopathology" (p. ). moreover, there is limited evidence that rdoc has actually improved the development of treatments for children (e.g., clarkson et al. ) . as i will discuss later in the paper, rush and ibrahim ( ) , in their critical review of psychiatric diagnosis, predicted that ai, especially artificial neural networks, will change the nature of diagnosis to support precision medicine. if measures are going to be used in real world practice, then in addition to the classic and modern psychometric validity criteria, it must be possible to use measures sufficiently often to provide a fine-grained picture of change. if measures are used frequently, then they must be short so as not to take up clinical time (riemer et al. ) . moreover, since there is a low correlation among different respondents (de los reyes and ohannessian ), we need measures and data from different respondents including parents, clinicians, clients, and others (e.g., teachers). however, we are still lacking a systematic methodology for managing these different perspectives. since we are still unsure which constructs are important to measure, we need measures of several different constructs in order to pinpoint which ones we should administer on a regular basis. in addition to outcome measures, we need valid and reliable indicators of mediators and processes to test theories of treatment as well as to indicate short-term outcomes. we need measures that are sensitive to change to be valid measures of improvement. we need new types of measures that are more contextual, that occur outside of therapy sessions, and that are not just standardized questionnaires. we lack good measures of fidelity of implementation that capture in an efficient manner what clinicians actually do in therapy sessions. this information is required to provide critical feedback to clinicians. we also lack biomarkers of mental illness that can be used to develop and evaluate treatments that are often found in physical illnesses. this is a long and incomplete list of needs and meeting them will be difficult to accomplish without a concerted effort. there are some resources at the national institutes of health that are focused on measure development, such as patient-reported outcomes measurement system information (promis) (https ://www.healt hmeas ures.net/explo re-measu remen t-syste ms/promi s), but this program does not focus on mental health. thus, we depend upon the slow and uncoordinated piecemeal efforts of individual researchers to somehow fit measure development into their career paths. i know this intimately because when i started to be engaged with children's mental health services research, i found that the measures in use were too long, too expensive, and far from agile. this dissatisfaction led me down a long path to the development of a battery of measures called the peabody treatment progress battery riemer et al. ). this battery of brief measures was developed as part of ongoing research grants and not with any specific external support. for over a half century, i have been a committed experimentalist. i still am a big fan of experiments for some purposes (bickman ). the first independent study i conducted was my honors thesis at city college of new york in . my professor was a parapsychologist and personality psychologist, so the subject of my thesis was extrasensory perception (esp). my honors advisor had developed a theory of esp that predicted that those who were positive about esp, whom she called sheep, would be better at esp than the people who rejected esp, whom she called goats (schmeidler ) . although i did not realize it at the time, my experimentalist or action orientation was not satisfied with correlational findings that were the core of the personality approach. i designed an experiment in which i randomly assigned college students to hear a scripted talk from me supporting or debunking esp. i found very powerful results. the experimental manipulation changed people's perspective on the efficacy of esp, but i found no effect on actual esp scores. it was not until i finished my master's degree in experimental psychopathology at columbia university that i realized that i wanted to be an experimental social psychologist, and i became a graduate student at the city university of new york. however, i did not accept the predominant approach of social psychologists, which was laboratory experimentation. i was convinced that research needed to take place in the real world. although my dissertation was a laboratory study of helping behavior in an emergency , it was the last lab study i did that was not also paired with a field experiment (e.g. bickman and rosenbaum ) . one of my first published research studies as a graduate student was a widely cited field experiment (rct) that examined compliance to men in different uniforms in everyday settings (bickman a, b) . the first book i coedited, as a graduate student, was titled beyond the laboratory: field research in social psychology and was composed primarily of field experiments (bickman and henchy ) . almost all my early work as a social psychologist consisted of field experiments . i strongly supported the primacy of randomized designs in several textbooks i coauthored or coedited (alasuutari et al. ; bickman and rog ; bickman and rog ; hedrick et al. ) . while the fort bragg study i described above was a quasi-experiment (bickman ) , i was not happy that the funding agency, the u.s. army, did not permit me to use a rct for evaluating an important policy issue. as i was truly committed to using a rct to evaluate systems of care, i followed up this study with a conceptual replication in a civilian community using a rct (bickman et al. b ) that was funded by a nimh grant. while i have valued the rct and continue to do so, i have come to the conclusion that our experimental methods were developed for simpler problems. mental health research is more like weather forecasting with thousands of variables rather than like traditional experimentation, which is based on a century-old model for evaluating agricultural experiments with only a few variables (hall ) . we need alternatives to the traditional way of doing research, service development, and service delivery that recognize the complexity of disorders, heterogeneity of clients, and varied contexts of mental health services. the oversimplification of rcts has produced a blunt tool that has not served us well for swiftly improving our services. this is not to say that there has been no change in the last years. for example, the institute of education sciences, a more recent player the field of children's behavioral and mental health outcomes research, has released an informative monograph on the use of adaptive randomized trials that does demonstrate flexibility in describing how rcts can be implemented in innovative ways (nahum-shani and almirall ). the concerns about rcts are also apparent in other fields. for example, a special issue of social science and medicine focused on the limitations of rcts (deaton and cartwright ) . the contributors to this incisive issue indicated that a rct does not in practice equalize treatment and control groups. rcts do not deliver precise estimates of average treatment effects (ates) because a rct is typically just one trial, and precision depends on numerous trials. there is also an external validity problem; that is, it is difficult to generalize from rcts, especially those done in university laboratory settings. context is critical and theory confirmation/disconfirmation is important, for without generalizability, the findings are difficult to apply in the real world (bickman et al. ) . scaling up from a rigorous rct to a community-based treatment is now recognized as a significant problem in the relatively new fields of translational research and implementation sciences. in addition to scaling up, there is a major issue in scaling down to the individual client level. stratification and theory help, but they are still at the group level. the classic inferential approach also has problems with replication, clinical meaningfulness, accurate application to individuals, and p-value testing (dwyer et al. ) . the primary clinical problem with rcts is the emphasis on average treatment effects (ates) versus individual prediction. rcts emphasize postdiction, and ates lead to necessary oversimplification and a focus on group differences and not individuals. subramanian et al. ( ) gave two examples of the fallacy of averages: the first was a study to describe the "ideal woman," where they measured nine body dimensions and then averaged each one. a contest to identity the "average woman" got responses, but not a single woman matched the averages on all nine variables. in a second example, the u.s. air force in measured pilots on body dimensions to determine appropriate specifications for a cockpit. not a single pilot matched the averages on even as few as dimensions, even when their measurements fell within % of the mean value. as these examples show, the problem with using averages has been known for a long time, but we have tended to ignore this problem. we are disappointed when clinicians do not use our research findings when in fact our findings may not be very useful for clinicians because clinicians deal with individual clients and not some hypothetical average client. we can obtain significant differences in averages between groups, but the persons who actually benefit from therapy will vary widely to the extent to which they respond to the recommended treatments. thus, the usefulness of our results depends in part on the heterogeneity of the clients and the variability of the findings. the privileging of rcts also came with additional baggage. instead of trying to use generalizable samples of participants, the methodology favored the reduction of heterogeneity as a way to increase the probability of finding statistically significant results. this often resulted in the exclusion from studies of whole groups of people, such as women, children, people of color, and persons with more than one diagnosis. while discussions often included an acknowledgment of this limitation, little was done about these artificial limitations until inclusion of certain groups was required by federal funding agencies (national institutes of health, central resource for grants and funding information ) . the limitations of rcts are not a secret, but we tend to ignore these limitations (kent et al. ) . one attempt to solve the difficulty of translating average effect sizes by rcts to individualize predictions is called reference class forecasting. here, the investigator attempts to make predictions for individuals based on "similar" persons treated with alternative therapies. however, it is rarely the case that everyone in a clinical trial is influenced by the treatment in the same way. an attempt to reduce this heterogeneity of treatment effects (hte) by using conventional subgroup analysis with one variable at a time is rejected by kent et al. ( ) . they argue that this approach does not work. first, there are many variables on which participants can differ, and there is no way to produce the number of groups that represent these differences. for example, matching on just binary variables would produce over a million groups. moreover, one would have to start with an enormous sample to maintain adequate statistical power. the authors describe several technical reasons for not recommending this approach to dealing with the hte problem. they also suggested two other statistical approaches, risk modeling and treatment effect modeling, that may be useful, but more research on both is needed to support their use. kent et al. ( ) briefly discussed using observational or non-rct data, but they pointed out the typical problems of missing data and other data quality issues as well as the difficulty in making causal attributions. moreover, they reiterated their support for the rct as the "gold standard." although published in , their article mentioned machine learning only as a question for future research-a question that i address later in this paper. i will also present other statistical approaches to solving the limitations of rcts. there is another problem in depending upon rcts as the gold standard. nadin ( ) pointed out that failed reproducibility occurs almost exclusively in life sciences, in contrast to the physical sciences. i would add that the behavioral sciences have not been immune from criticisms about replicability. the open science collaboration ( ) systematically sampled results from three top-tier journals in psychology, and only % of the replication efforts yielded significant findings. this issue is far from resolved, and it is much more complex than simple replication (laraway et al. ) . nadin ( ) considered the issue of the replicability as evidence of an underlying false assumption about treating humans as if they were mechanistic physical objects and not reactive human beings. he noted that physics is nomothetic, while biology is idiographic, meaning that the former is the study of the formulation of universal laws and the latter deals with the study of individual cases or events. without accurate feedback, there is little learning (kluger and denisi ) . clinicians are in a low feedback occupation, and unlike carpenters or surgeons, they are unlikely to get direct accurate feedback on the effects of their activities. when carpenters cut something too short, they can quickly see that it no longer fits and have to start with a new piece, so they typically follow the maxim of measure twice, cut once. because clinicians in the real world of treatment do not get direct accurate feedback on client outcomes, especially after clients leave treatment, then they are unlikely to learn how to become more effective clinicians from practice alone. clinical practice is thus similar to an archer's trying to improve while practicing blindfolded (bickman ) . moreover, the services research field does not learn from treatment as usual in the real world, where most treatment occurs, because very few services collect outcome data, let alone try to tie these data to clinician actions (bickman b) . there are two critical requirements needed for learning. the first is the collection of fine-grained data that are contemporaneous with treatment. the second is the feedback of these data to the clinician or others so that they can learn from these data. learning can be accomplished with routine use of measures such as patient outcome measures (poms) and feedback through progress monitoring, measurementbased care (mbc), and measurement feedback systems (mfs). these measurement feedback concepts have repeatedly demonstrated their ability to improve outcomes in therapy across treatment type and patient populations (brattland et al. ; bickman et al. ; dyer et al. ; gibbons ; gondek et al. ; lambert et al. ) . despite this evidence base, most clinicians do not use these measurement feedback systems. for example, in one of the largest surveys of canadian psychologists, only % were using a progress monitoring measure (ionita et al. ) . a canadian psychological association task force (tasca et al. ) reinforced the need for psychologists to systematically monitor and evaluate their services using continuous monitoring and feedback. they stated that the association should encourage regulatory bodies to prioritize training in their continuing education and quality assurance requirements. moreover, lewis et al., in their review of measurement-based care ( ), presented a -point research agenda that captures much the ideas in the present paper: ( ) harmonize terminology and specify mbc's core components; ( ) develop criterion standard methods for monitoring fidelity and reporting quality of implementation; ( ) develop algorithms for mbc to guide psychotherapy; ( ) test putative mechanisms of change, particularly for psychotherapy; ( ) develop brief and psychometrically strong measures for use in combination; ( ) assess the critical timing of administration needed to optimize patient outcomes; ( ) streamline measurement feedback systems to include only key ingredients and enhance electronic health record interoperability; ( ) identify discrete strategies to support implementation; ( ) make evidence-based policy decisions; and ( ) align reimbursement structures. (p. ) it is not surprising that the measurement feedback approach has not yet produced dramatic effects, given how little we know about what data to collect, how often it should be collected, what feedback should be, and when and how it should be provided (bickman et al. ) . regardless, every time a client is treated, it is an opportunity to learn how to be more effective. by not collecting and analyzing information from usual care settings, we are missing a major opportunity to learn from ordinary services. the most successful model i know of using this real-world services approach is the treatment of childhood cancers in hospitals where most children enter a treatment rct (o'leary et al. ) . these authors note that in the past years, the survival rates for childhood cancer have climbed from % to almost %. they attribute this remarkable improvement to clinical research through pediatric cooperative groups. this level of cooperation is not easy to develop, and it is not frequently found in mental health services. most previous research shows differential outcomes among different types of therapies that are minor at most (wampold and imel ) . for example, weisz et al. ( ) report that in their meta-analysis, the effect of treatment type as a moderator was not statistically significant but there was a significant, but not clearly understood, treatment type by informant interaction effect. in addition, the evidence that therapists have a major influence on the outcomes of psychotherapy is still being hotly debated. the fact that the efficacy of therapists is far from a settled issue is troubling (anderson et al. ; goodyear et al. ; hill et al. ; king and bickman ) . also, current drug treatment choices in psychiatry are successful in only about % of the patients (bzdok and meyer-lindenberg ) and are as low as - % for antidepressants (dwyer et al. ) . while antidepressants are more effective than placebos, they have small effect sizes (perlis ) , and the choice of specific medicine is a matter of trial and error in many cases. it is relatively easy to distinguish one type of drug from another but not so for services, where even dosage in psychosocial treatments is hard to define. according to dwyer et al. ( ) , "currently, there are no objective, personalized methods to choose among multiple options when tailoring optimal psychotherapeutic and pharmacological treatment" (p. ). a recent summary concluded that after years and studies, it is unknown which patients benefit from interpersonal psychotherapy (ipt) versus another treatment (bernecker et al. ) . however, to provide a more definitive answer to the question about which treatments are more effective, we need head-to-head direct comparisons between different treatments and network meta-analytic approaches such as those used by dagnea et al. ( ) . the field of mental health is not alone in finding that many popular medications do not work with most of the people who take them. nexium, a common drug for treating heartburn, works with only person out of , while crestor, used to treat high cholesterol, works with only out of (schork ) . this poor alignment between what the patient needs, and the treatment provided is the primary basis for calling for a more precise medicine approach. this lack of precision leads to the application of treatments to people who cannot benefit from it, thus leading to overall poor effectiveness. in summary, a deep and growing body of work has led me to conclude that we need additional viable approaches to a rct when it comes to conducting services-related research. an absence of rigorous evaluation of treatments that are usually provided in the community contributes to a gap in our understanding why treatments are ineffective (bickman b) . poor use of measurement in routine care (bickman ) and the absence of measurement feedback systems and clinician training and supervision (garland et al. ) are rampant. there also a dire need for the application of more advanced analytics and data mining techniques in the mental health services area (bickman et al. ). these and other such challenges have in turn informed my current thinking about alternative or ancillary approaches for addressing the multitude of problems plaguing the field of mental health services. the five problems i have described above constitute significant obstacles to achieving accessibility, efficiency, and effectiveness in mental health services. nevertheless, there is a path forward that i believe can help us reach these goals. artificial intelligence promises to transform the way healthcare is delivered. the core of my recommendations in this paper rests on the revolutionary possibilities of artificial intelligence for improving mental healthcare through precision medicine that allows us to take into account the individual variability that exists with respect to genetic and other biological, environmental, and lifestyle characteristics. several others have similarly signaled a need for considering the use of personalized approaches to service delivery. for example, weisz and his colleagues (marchette and weisz ; ng and weisz ) called for more idiographic research and for studies tailoring strategies in usual care. kazdin ( ) focused on expanding mental health services through novel models of intervention delivery; called for task shifting among providers; advocated designing and implementing treatments that are more feasible, using disruptive technologies, for example, smartphones, social media such as twitter and facebook, and socially assistive robots; and emphasized social network interventions to connect with similar people. ai is currently used in areas ranging from prediction of weather patterns to manufacturing, logistic planning to determine efficient delivery routes, banking, and stock trading. ai is used in smartphones, cars, planes, and the digital assistants siri and alexa. in healthcare, decision support, testing and diagnosis, and self-care also use ai. ai can sort through large data sets and uncover relationships that humans cannot perceive. through learning that occurs with repeated, rapid use, ai surpasses the abilities of humans only in some areas. however, i would caution potential users that there are significant limitations associated with ai that are discussed later in this paper. rudin and carlson ( ) present a non-technical and well written review of how to utilize ai and of some of the problems that are typically encountered. ai is not one type of program or algorithm. machine learning (ml), a major type of ai, is the construction of algorithms that can learn from and make predictions based on data. it can be ( ) supervised, in which the outcome is known and labeled by humans and the algorithm learns to get that outcome; ( ) unsupervised, when the program learns from data to predict specific outcomes likely to come from the patterns identified; and ( ) reinforcement learning, in which ml is trial and error. in most cases, there is an extensive training data set that the algorithm "learns" from, followed by an independent validation sample that tests the validity of the algorithm. other variations of ai include random forest, decision trees, and the support vector machine (svm), a multivariate supervised learning technique that classifies individuals into groups (dwyer et al. ; shrivastava et al. ). the latter is most widely used in psychology and psychiatry. artificial neural networks (anns) or "neural networks" (nns) are learning algorithms that are conceptuality related to biological neural networks. this approach can have many hidden layers. deep learning is a special type of machine learning. it helps to build learning algorithms that can function conceptually in a way similar to the functioning of the human brain. large amounts of data are required to use deep learning. ibm's watson won jeopardy with deepqa algorithms designed for question answering. as exemplified by the term neural networks, algorithm developers appear to name their different approaches with reference to some biological process. genetic algorithms are based on the biological process of gene propagation and the methods of natural selection, and they try to mimic the process of natural evolution at the genotype level. it has been a widely used approach since the s. natural language processing (nlp) involves speech recognition, natural language understanding, and natural language generation. nlp may be especially useful in analyzing recordings of a therapy session or a therapist's notes. affective computing or sentiment analysis involves the emotion recognition, modeling, and expression of emotion by robots or chatbots. sentiment analysis can recognize and respond to human emotions. virtual reality and augmented reality are human-computer interfaces that allow a user to become immersed within and interact with computer-generated simulated environments. hinton ( ) , a major contributor to research on ai and health, described ai as the use of algorithms and software to approximate human cognition in the analysis of complex data without being explicitly programmed. the primary aim of health-related ai applications is to analyze relationships between prevention or treatment techniques and patient outcomes. ai programs have been developed and applied to practices such as diagnosis processes, treatment protocol development, drug development, personalized medicine, and patient monitoring and care. deep learning is best at modeling very complicated relationships between input and outputs and all their interactions, and it sometimes requires a very large number of cases-in the thousands or tens of thousands-to learn. however, there appears to be no consensus about how to determine, a priori, the number of cases needed, because the number is highly dependent on the nature of the problem and the characteristics of the data. ai is already widely used in medicine. for example, in ophthalmology, photos of the eyes of persons with diabetes were screened with % specificity and % sensitivity in detecting diabetes (gargeya and leng ) . one of the more prolific uses of ai is in the diagnosis of skin cancer. in a study that scanned , clinical images, the ai approach had accuracy similar to that of board-certified dermatologists (esteva et al. ) . cardiovascular risk prediction with ml is significantly improved over established methods of risk prediction (krittanawong et al. ; weng et al. ). however, a study by desai et al. ( ) found only limited improvements in predicting heart failure over traditional logistic regression. in cancer diagnostics, ai identified malignant tumors with % accuracy compared to % accuracy for human pathologists (liu et al. ). the ibm's watson ai platform took only min to analyze a genome of a patient with brain cancer and suggest a treatment plan, while human experts took h (wrzeszczynski et al. ) . ai has also been used to develop personalized immunotherapy for cancer treatment (kiyotani et al. ). rajpurkar et al. ( ) compared chest x-rays for signs of pneumonia using a state-of-the-art -layer convolutional neural network (cnn) program with a "swarm" of radiologists (groups connected by swarm algorithms) and found the latter to be significantly more accurate. in a direct comparison between radiologists on , interpretations and a stand-alone deep learning ai program designed to detect breast cancer in mammography, the ai program was as accurate as the radiologists (rodriguez-ruiz et al. ). as topol ( b) noted, ai is not always the winner in comparison with human experts. moreover, many of these applications have not been used in the real world, so we do not know how well ai will scale up in practice. topol describes other concerns with ai, many of which are discussed later in this paper. finally, many of the applications are visual, such as pictures of skin or scans, for which ai is particularly well suited. large banks of pictures often form the training and testing data for this approach. in mental health, visual data are not currently as relevant. however, there is starting to be some research on facial expressions in diagnosing mental illness. for example, abdullah and choudhury ( ) cite several studies that showed that patients with schizophrenia tend to show reduced facial expressivity or that facial features can be used to indicate mental health status. more generally, there is research showing how facial expressions can be used to indicate stress (mayo and heilig ) . visual data are ripe for exploration using ai. although an exhaustive review of the ai literature and its applications is well beyond the focus of this paper, rudin and carlson ( ) present a well-written, non-technical review of how to utilize ai and of some of the problems that are typically encountered. topol ( a) , in his book titled deep medicine: how artificial intelligence can make healthcare human again, includes a chapter on how to use of ai in mental health. topol ( b) also provides an excellent review of ai and its application to health and mental health in a briefer format. buskirk et al. ( ) and y. liu et al. ( ) provide well-written and relatively brief introductions to ml's basic concepts and methods and how they are evaluated. a more detailed introduction to deep learning and neural networks is provided by minar and naher ( ) . in most cases, i will use the generic term ai to refer to all types of ai unless the specific type of ai (e.g., ml for machine learning, dl for deep learning, and dnn for deep neural networks) is specified. precision medicine has been defined as the customization of healthcare, with medical decisions, treatments, practices, or products being tailored to the individual patient (love-koh et al. ) . typically, diagnostic testing is used for selecting the appropriate and best therapies based a person's genetic makeup or other analysis. in an idealized scenario, a person may be monitored with hundreds of inputs from various sources that use ai to make predictions. the hope is that precision medicine will replace annual doctor visits and their granular risk factors with individualized profiles and continuous longitudinal health monitoring (gambhir et al. ) . the aim of precision medicine, as stated by president barack obama when announcing his precision medicine initiative, is to find the long-sought goal of "delivering the right treatments, at the right time, every time to the right person" (kaiser ) . both ai and precision medicine can be considered revolutionary in the delivery of healthcare, since they enable us to move from one-size-fits-all diagnoses and treatment to individualized diagnoses and treatments that are based on vast amounts of data collected in healthcare settings. the use of ai and precision medicine to guide clinicians will change diagnoses and treatments in significant ways that will go beyond our dependence on the traditional rct. precision medicine should also be seen as evolutionary since even hippocrates advocated personalizing medicine (kohler ) . the importance of a precision medicine approach was recognized in the field of prevention science with a special issue of prevention science devoted to that topic (august and gewirtz ) . the articles in this special issue recognize the importance of identifying moderators of treatment that predict heterogeneous responses to treatment. describing moderators is a key feature of precision medicine. once these variables are discovered, it becomes possible to develop decision support systems that assist the provider (or even do the treatment assignment) in selecting the most appropriate treatment for each individual. this general approach has been tried using a sequential multiple assignment randomized trial (smart) in which participants are randomized two to three times at key decision points (august et al. ) . what i find notable about this special issue is the absence of any focus on ai. the articles were based on a conference in october , and apparently the relevance of ai had not yet influenced these very creative and thoughtful researchers at that point. precision medicine does not have an easy path to follow. x. liu et al. ( b) describe several challenges, including the following three. large parts of the human genome are not well enough known to support analyses; for example, almost % of our genetic code is unknown. it is also clear that a successful precision medicine approach depends on having access to large amounts of data at multiple levels, from the genetic to the behavioral. moreover, these data would have be placed into libraries that allow access for researchers. the u.s. federal government has a goal of establishing such a library with data on one million people through nih's all of us research program (https ://allof us.nih.gov/). recruitment of volunteers who would be willing to provide data and the "harmonization" of data from many different sources are major issues. x. liu et al. ( b) also point to ethical issues that confront precision medicine, such as informed consent, privacy, and predictions that someone may develop a disease. these issues are discussed later in this paper. chanfreau-coffinier et al. ( ) provided a helpful illustration of how precision medicine could be implemented. they convened a conference of veterans affairs stakeholders to develop a detailed logic model that can be used by an organization planning to introduce precision medicine. this model includes components typically found in logic models, such as inputs (clinical and information technology), big data (analytics, data sources), resources (workforce, funding) activities (research), outcomes (healthcare utilization), and impacts (access). the paper also includes challenges to implementing precision medicine (e.g., a poorly trained workforce) that apply to mental health. ai has the potential to unscramble traditional and new diagnostic categories based on analysis of biological/genetic and psychological data, and in addition, more data will likely be generated now that the potential for analysis has become so much greater. ai also has the potential to pinpoint those individuals who have the highest probability of benefiting from specific treatments and to provide early indicators of success or failure of treatment. research is currently being undertaken to provide feedback to clinicians at key decision points as an early warning of relapse. fernandes et al. ( ) describe what the authors call the domains related to precision psychiatry (see fig. ). these domains include many approaches and techniques, such as panomics, neuroimaging, cognition, and clinical characteristics, that form several domains including big data and molecular biosignature; the latter includes biomarkers. the authors include data from electronic health records, but i would also include data collected from treatment or therapy sessions as well as data collected outside of these sessions. these domains can be analyzed using biological and computational tools to produce a biosignature, a higher order domain that includes data from all the lower level techniques and approaches. this set of biomarkers in the biosignature should result in improved diagnosis, classification, and prognosis, as well as individualized interventions. the authors note that this bottom-up approach, from specific approaches to domains to the ultimate biosignature, can also be revised to a top-down approach, with the biosignature studied to better understand domains and its specific components. the bottom of the figure shows a paradigm shift where precision psychiatry contributes to different treatments being applied to persons with different diagnoses and endophenotypes, producing different prognoses. endophenotypes is a term used in genetic epidemiology to separate different behavioral another perspective on precision psychiatry is presented by bzdock and meyer-lindberg ( ). both models contain similar concepts. both start with a group of persons containing multiple traditional diagnoses. bzdock and meyer-lindberg recognize that these psychiatric diagnoses are often artificial dichotomies. machine learning is applied to diverse data from many sources and extracts hidden relationships. this produces different subgroups of endophenotypes. machine learning is also used to produce predictive models of the effects of different treatments instead of the more typical trial and error. further refinement of the predictive ml models results in better treatment selection and better prediction of the disease trajectory. an excellent overview of deep neural networks (dnns) in psychiatry and its applications is provided by durstewitz et al. ( ) . in addition to explaining how dnns work, they provide some suggestions on how dnns can be used in clinical practice with smartphones and large data sets. a major feature of deep neural networks is their ability to learn and adapt with experience. while dnns typically outperform ml, the authors state that they do not fully understand why this is the case. in mental health, dnns have been mostly used in diagnosis and predictions but not in designing personalized treatments. dnn's ability to integrate many different data sets (e.g., various neuroimaging data, movement patterns, social media, and genomics) should provide important insights on how to personalize treatments. regardless of the model used, eyre et al. ( ) remind us that consumers should not be left out of the development of precision psychiatry. in my conceptualization of precision medicine, precision mental health encompasses precision psychiatry and any other precision approach such as social work that focuses on mental health (bickman et al. ). there has not been much written about using a precision approach with psychosocial mental health services. possibly it is psychiatry's close relationship to general medicine and its roots in biology that make psychiatry more amenable to the precision science approach. in addition, the use of the precision construct is being applied in other fields, as exemplified by the special issue of the journal of school psychology devoted to precision education (cook et al. ) and precision public health (kee and taylor-robinson ) . however, in this paper i am primarily addressing the use of psychosocial treatment of mental health problems, which differs in important ways from psychiatric treatment. for example, precision psychosocial mental health treatment does not have a strong biological/medical perspective and does not focus almost exclusively on medication; instead, it emphasizes psychosocial interventions. psychosocial mental health services are also provided in hospital settings, but their primary use is in community-based services. these differences lead to different data sources for ai analyses. it is highly unlikely that electronic mental healthcare records found outside of hospital settings contain biological and genomic data (serretti ) . but hospital records are not likely to contain the detailed treatment process data that could possibly be found in community settings. the genomic and biological data offer new perspectives but may not be informative until we have a better understanding about the genomic basis of mental illness. in addition, the internet of things and smart healthcare connect wearable and home-based sensors that can be used to monitor movement, heart rate, ecg, emg, oxygen level, sleep, and blood glucose, through wi-fi, bluetooth, and related technologies. (sundaravadivel et al. ) . with wider use of very fast g internet service, there will be a major increase in the growth of the internet of things. i want to emphasize that applying precision medicine concepts to mental health services, especially psychotherapy, is a very difficult undertaking. the data requirements for psychosocial mental health treatment are more similar to meteorology or weather forecasting than to agriculture, which is considered the origin of the rct design. people's affect, cognition, and behavior are constantly changing just like the variables that affect weather. but unlike meteorology, which is mainly descriptive and not yet engaged in interventions, mental health services are interventions. thus, in addition to client data, we must identify the variables that are critical to the success of the intervention. we are beginning to grasp how difficult this task is as we develop greater understanding that the mere labeling of different forms of treatment by location (e.g., hospital or outpatient) or by generic type (e.g., cognitive behavior therapy) is not sufficiently informative. moreover, the emergence of implementation sciences has forced us to face the fact that a treatment manual describes only some aspects of the treatments as intended but does not describe the treatment that is actually delivered. nlp is a step in the right direction in trying to capture some aspects of treatment as actually delivered. data quality is the foundation upon which ai systems are built. while medical records are of higher technical quality than community-based data because they must adhere to national standards, i believe that the nascent interest in measurement-based care and measurement feedback systems in community settings bodes well for improved data systems in the future. moreover, although electronic hospitalbased data may be high quality from a technical viewpoint (validity, reliability) and be very large, they probably do not contain the data that are valuable for developing and evaluating mental health services. the development of electronic computer-based data collection and feedback systems will become more common as the growth in ai demands large amounts of good-quality treatment and finer grained longitudinal outcome data. there is a potential reciprocal relationship between the ai needs for large, high-quality data sets and the development of new measurement approaches and the electronic systems needed to collect such data (bickman a; bickman et al. a bickman et al. , . to accomplish this with sufficiently unbiased and valid data will be a challenge. ai can bypass many definitional problems by not using established diagnostic systems. ml can use a range of variables to describe the individual ml classifier systems (tandon and tandon ) . moreover, additional sources of data that help in classification are now feasible. for example, automated analysis of social media including tweets and facebook can detect depression, with accuracy measured by area under the curve (auc) ranging from . to . compared to clinical interviews with aucs of . (guntuku et al. ). as noted earlier, dnns have been shown to be superior to other machine learning approaches in general and specifically in identifying psychiatric stressors for suicide from social media (du et al. ). predictions of , adolescent suicides with ml showed high accuracy (auc > . ) and outperformed traditional logistic regression analyses ( . - . aucs) (tandon and tandon ) . saxe has published a pioneering proof of concept that has demonstrated that ml methods can be used to predict child posttraumatic stress (saxe et al. ) . ml was more accurate than humans in predicting social and occupational disability with persons in high-risk states of psychosis or with recent-onset depression (koutsouleris et al. a) . machine learning has also been used in predicting psychosis using everyday language (rezaii et al. ) . another application of ai to diagnosis is provided by kasthurirathne et al. ( ) . they demonstrated the ability to automate screening for , adult patients in need of advanced care for depression using structured and unstructured data sets covering acute and chronic conditions, patient demographics, behaviors, and past service use history. the use of many existing data elements is a key feature and thus does not depend on single screening instruments. the authors used this information to accurately predict the need for advanced care for depression using random forest classification ml. milne et al. ( ) recognized that in implementing online peer counseling, professionals need to participate and/or provide safety monitoring in using ai. however, cost and scalability issues appeared to be insurmountable barriers. what is needed is an automated triage system that would direct human moderators to cases that require the most urgent attention. the triage system milne et al. developed sent human moderators color-coded messages about their need to intervene. the algorithm supporting this triage system was based on supervised ml. the accuracy of the system was evaluated by comparing a test set of manually prioritized messages with the ones developed through the algorithm. they used several methods to judge accuracy, but their main one was an f-measure, or the harmonic mean of recall (i.e., sensitivity) and precision (i.e., positive predictive value). regression analysis indicated that the triage system made a significant and unique contribution to reducing the time taken to respond to some messages, after accounting for moderator and community activity. i can see the potential for this and similar ai approaches to deal with the typical service setting where some degree of supervision is required but even intermittent supervision is not feasible or possible. another use of ml as a classification tool is provided by pigoni et al. ( ) . in their review of treatment resistant depression, they found that ml could be used successfully to classify responders from non-responders. this suggested that stratification of patients might help in selecting the appropriate treatment, thus avoiding giving patients treatments that are unlikely to work with them. a more general systematic review and meta-analysis of the use of ml to predict depression are provided by lee et al. ( ) . the authors found qualitative and quantitative studies that qualified for inclusion in their review. while most of the studies were retrospective, they did find predictions with an average overall accuracy of . . kaur and sharma ( ) reviewed the literature on diagnosis of ten different psychological disorders and examined the different data mining and software approaches (ai) used in different publications. depending on the disorder and the software used, the accuracy ranged from to %. accuracy was defined differently depending on the study. only % of the articles exploring diagnosis of any health problem were found to be for psychological problems. this suggests that we need more studies on diagnosis and ai. a very informative synthesis and review are provided by low et al. ( ) . they screened studies and reviewed the that met the inclusion criterion: studies from the last years using speech to identify the presence or severity of disorders through ml methods. they concluded that ml could be predictive, but confidence in any conclusions was dampened by the general lack of cross-validation procedures. the article contains very useful information on how best to collect and analyze speech samples. another innovative approach using ml focused on wearable motion detector sensors, in which these devices were worn for s during a -s mood induction task (seeing a fake snake). these data were able to distinguish children with an internalizing disorder from controls with % accuracy (mcginnis et al. ) . this approach has potential for screening children for this disorder. a problem that seemingly has been ignored by most studies that deal with classification or diagnosis is the gold standard by which accuracy is judged. in most cases, the gold standard is human judgment, which is especially fallible when it comes to mental health diagnosis. we can clearly measure whether the ai approach is faster and less expensive than human judgment, but is the ultimate in ai accuracy matching human judgment with all its flaws? i believe that the endpoint that must also be measured is client clinical mental health improvement. a system that provides faster and less expensive diagnosis but does not lead to more precise treatment and better clinical outcomes will save us time and money, which are important, but they will not be the breakthrough for which we are looking. a solution to the problems described above will involve the integration of causal discovery methods with ai approaches. ai methods are capable of improving our capacity to predict outcomes. to enhance predictability, we will need to identify the factors in the predictive models that are causal. thus, there is the need to identify techniques that provide us with causal knowledge, which currently is based primarily on rcts. but, for real-world and ethical reasons, human etiological experiments can rarely be conducted. fortunately, there are newer ai methods that can be used to infer causes, which include well validated tests of conditional independencies based on the causal markov condition (pearl ; aliferis et al. ; saxe ) . these methods have been successfully used outside of psychiatry (sachs et al. ; ramsey et al. ; statnikov et al. ) and have, in the last five years, been applied in research on mental health, largely by the team of glenn saxe at new york university and constantin aliferis and sisi ma at university of minnesota. this group has reported causal models of ptsd in hospitalized injured children (saxe et al. (saxe et al. , , children seen in outpatient trauma centers (saxe et al. ) , maltreated children (morales et al. ) , adults seen in emergency rooms (galatzer-levy et al. ) , and police officers who were exposed to trauma (saxe et al. in press ). saxe ( ) recently described the promise of these methods for psychiatric diagnosis and personalized precision medicine. new measures need to be developed that cover multiple domains of mental health, are reported by different respondents (e.g., child, parent, clinician), and are very brief. cohen ( ) provides an excellent overview of what he calls ambulatory biobehavioral technologies in a special section of psychological assessment. he notes that the development of mobile devices can have a major impact on psychological assessment. he cautions, however, that while some of these approaches have been used for decades, they still have not progressed beyond the proof of concept phase for clinical and commercial applications. ecological momentary assessment (ema) is a relatively new approach to measurement development. ema is the collection of real-time data collected in naturalistic environments. this approach uses a wide range of smart watches, bands, garments, and patches with embedded sensors (gharani et al. ; pistorius ) . for example, using smartphones, researchers have identified gait features for estimating blood alcohol content level (gharani et al. ). other researchers have been able to map changes in emotional state ranging from sad to happy by using a movement sensor on smart watches (quiroz et al. ) . others have described real-time fluctuations in suicidal ideation and its risk factors, using an average of . assessments per day (kleiman et al. ) . social anxiety has been assessed from global positioning data obtained from smart watches by noting that socially anxious students were found to avoid public places and to spend more time at home than in leisure activities outside the home (boukhechba et al. ) . a review of studies using ema concluded that the compliance rate was moderate but not optimal and could be affected by study design (wen et al. ). this review is also a good source of descriptions of different approaches to using ema. another good summary that focused on ema in the treatment of psychotic disorders can be found in bell et al. ( ) . for ema use in depression and anxiety, schueller et al. ( ) is a good source. ema has been used to measure cardiorespiratory function, movement patterns, sweat analysis, tissue oxygenation, sleep, and emotional state (peake et al. ) . harari et al. ( ) present a catalog of behavior in more than aspects of daily living that can be used in studying physical movement, social interactions, and daily activities. these include walking, speaking, text messaging, and so on. these all can be collected from smartphones and serve as an alternative to traditional survey approaches. however, it is still not clear what higher-level constructs are measured using these approaches. a comprehensive and in-depth review of studies that have used speech to assess psychiatric disorders is provided by low et al. ( ) . they conclude that speech processing technology could assist in mental health assessments but believe that there are many obstacles to this use, including the need for longitudinal studies. another interesting application for children is the use of inexpensive screening for internalizing disorders. mcginnis et al. ( ) monitored the child's motion for s using a commercially available and inexpensive wearable sensor. using a supervised ml approach, they obtained an % accuracy ( % sensitivity, % specificity) compared to similar clinical threshold on parent-reported child symptoms that differentiate children with an internalizing diagnosis from controls without such a diagnosis. in a systematic review of ema use in major depression, colombo et al. ( ) evaluated studies that met their criteria for inclusion. these studies measured a wide variety of variables including self-reported symptoms, sleep patterns, social contacts, cortisol, heart rate, and affect. they point out many of the advantages of using emas such as realtime assessments, capturing the dynamic nature of change, improving generalizability, and providing information about context. they believe that the use of emas has resulted in novel insights about the nature of depression. they do note that there are few evaluations of these measures, and there is not much use in actual clinical practice. mohr et al. ( ) note that most of the research on ema has been carried out primarily by computer scientists and engineers using a very different research model than social and behavioral scientists. while computer scientists are mostly interested in exploratory proof of concepts approach (does it work at all?) using very small samples, social/behavioral scientists are more typically theory driven and investigate under what conditions the intervention will work. mental health care, apart from medication, is almost exclusively verbal. several approaches have been tried to capture the content of treatment sessions. my colleagues and i have tried by asking clinicians to use a brief checklist of topics discussed after each therapy session . although this technique produced some interesting findings such as the identification of topics that the clinician did not discuss but that were believed to be important by the youth or parent, it is clearly filtered by what the clinician recalls and is willing to check off as having been discussed. while recordings provide a richer source of information, coding recordings manually is too expensive and slow for the real world of service delivery. the content of therapy sessions, including notes kept by clinicians, is pretty much ignored by researchers because of the difficulty and cost of manually coding those sources. however, advances in natural language processing (nlp) are now being explored as a way of capturing aspects of the content of therapy sessions. for example, tanana et al. ( ) have shown how two types of nlp techniques can be used to study and code the use of motivational interviewing in taped sessions. carcone et al. ( ) also showed that they could accurately code motivational interviewing (mi) clinical encounter transcripts with sufficient accuracy. other researchers have used ai to analyze speech to distinguish between what they called high-and low-quality counselors (pérez-rosas et al. ). some colleagues and i have submitted a proposal to nimh to refine nlp tools that can be used to supervise clinicians implementing an evidence-based treatment using ai. as far as we know, using nlp to measure fidelity and provide feedback to clinicians has not been studied in a systematic way. while ai appears to be an attractive approach to new ways of analyzing data, it should be noted that, as always, the quality of the analysis is highly dependent on the quality of the data. jacobucci and grimm ( ) caution us that "in psychology specifically, the impact of machine learning has not been commensurate with what one would expect given the complexity of algorithms and their ability to capture nonlinear and interactive effects" (p. ). one observation made by these authors is that the apparent lack of progress in using ai may be caused by "throwing the same set of poorly measured variables that have been analyzed previously into machine learning algorithms" (p. ). they note that this is more than the generic garbage in, garbage out problem, but it is specifically related to measurement error, which can be measured relatively accurately. as described earlier, our privileging of rcts has contributed to a lack of focus on a precision approach to mental health services. this has resulted in the problem of ignoring the clinical need for predicting for an individual in contrast to establishing group difference, the approach favored by the experimentalist/ hypothesis testing tradition. ai offers an approach to the discovery of important relationships in mental health in addition to rcts that are based on singlesubject prediction accuracy and not null hypothesis testing (bzdok and karrer ) . saxe et al. ( ) have demonstrated the use of the complex-systems-causal network method to detect causal relationships among variables and bivariate relations in a psychiatric study using algorithms. a comprehensive review and meta-analysis of machine learning algorithms that predict outcomes of depression showed excellent accuracy ( . ) using multiple forms of data (lee et al. ) . it is interesting to note that none of the scholars commenting on the rct special issue in social science and medicine (deaton and cartwright ) specifically mentioned the use of ai as a potential solution to some of the problems of using average treatment effects (ates). kessler et al. ( a) noted that clinical trials do not tell us which treatments are more effective for which patients. they suggested that what they label as precision treatment rules (ptrs) be developed that are predictors of the relative treatment effectiveness of different treatments. the authors presented a comprehensive discussion on how to use ml to develop ptrs. they concluded that the sample sizes needed are much larger than usually those found in rcts; observational data, especially from electronic medical records (emrs) can be used to deal with the sample size issue; and statistical methods can be used to balance both observed and unobserved covariates using instrumental variables and discontinuity designs. they do note the difficulty in obtaining full baseline data from emrs and suggest several solutions for this problem, including supplemental data collection and links to other archival sources. they recommend the use of an ensemble ml approach that combines several algorithms. they are clear that their suggestions are exploratory and require verification, but they are more certain that if ml improves patient outcomes, it will be a substantial improvement. wu et al. ( ) collaborated with kessler on a proof of concept of a similar model called individualized treatment rules (itr). in a model simulation, they used a large sample (n = , ) with an ensemble ml method to identify the advantages of using ml algorithms to estimate the outcomes if a precision medicine approach was taken in prescribing medication for persons with first-onset schizophrenia. they found that the treatment success was estimated to be . % under itr compared to . % with the medication that was actually used. wu et al. see this as a first step that needs to be confirmed by pragmatic rcts. kessler et al. ( b) conducted a relatively small randomized study (n = ) in which soldiers seeking treatment were judged to be at risk for suicide. they were randomly assigned to two types of treatment but not on the basis of any a priori ptr. the data from that study were then analyzed using ml to produce ptrs. these data were then modeled in a simulation to see if the ptr would have produced better outcomes. the authors did find that the simulated ptr produced better effects. lenze et al. ( ) address the problems of rcts from a somewhat different perspective than i have presented here and suggest a potential solution that they call precision clinical trials (pcts). the authors propose that the problem with most existing rcts is that they measure only the fixed baseline characteristics that are not usually sensitive to detecting treatment responders. moreover, treatment is typically not dynamically adapting to the client during treatment, and measures are not administered with sufficient frequency. instead, the pcts would: ( ) first attempt to determine whether short-term responses to the intervention could determine who was a likely candidate for that specific treatment; ( ) initiate the treatment in an adaptive fashion that could vary over time, using stepped care or just-in-time adaptations that are responsive to the client's changing status, and frequently collect data possibly using multiple assignment randomized trial methods; and ( ) use frequent precision measurement, possibly using ecological momentary assessments described earlier. coincidently, they illustrate the application of pcts using repetitive transcranial magnetic stimulation (rtms), a form of brain stimulation therapy used to treat depression and anxiety that has been in use since . rtms will be described later in connection with what i call a third path for services and ai. it is disappointing that i could not find any examples of published research that used a rct to test whether an ai approach to an actual, not simulated, delivery of a mental health treatment produces better clinical outcomes than a competitive treatment or even treatment as usual. this is clearly an area requiring further rigorous empirical investigation. imel et al. ( ) provide an excellent overview on how ai and other technologies can be used for monitoring and feedback in psychotherapy in both training and supervision. imel et al. ( ) used ml to code and provide data to clinicians on metrics used to measure the quality of motivational interviewing (mi). a prior study (tanana et al. ) established that ml was able to code mi quality metrics with accuracy similar to human coders. they conducted a pilot study using standardized patients and -min speech segments that was designed to test the feasibility of providing feedback to clinicians on the quality of their mi intervention. the feedback was not in real-time but was provided after the session. they were able to establish that clinicians thought highly of the feedback they received. the authors anticipate that further developments in this technology will lead to its widespread use in supervision and in real-time feedback. it would seem that the next step is evaluating the enhanced ai feedback procedure in a real-world effectiveness study. another example of the use of nlp application is the use of a bot that was trained to assess and provide feedback on specific interviewing and counseling skills such as asking open-ended questions and providing feedback (tanana et al. ) . after training the bot on transcripts, non-therapists (using amazon mechanical turk recruits) were randomly assigned to either immediate feedback on a practice session with the bot or just encouragement on the use of those skills. the group provided the feedback were significantly more likely to use reflection even when feedback was removed. the authors consider this to be a proof of concept demonstration because of the many limitations (e.g., use of non-therapists). a plan for using nlp to monitor and provide feedback to clinicians on the implementation of an evidenced program is provided by berkel et al. ( ) . they provide excellent justification for using nlp to accomplish this goal, but unfortunately it is only a design at this point. rosenfeld et al. ( ) see ai making major contributions to improving the quality of treatment through efficient continuous monitoring of patients. until now, monitoring was limited to in-session contacts or manual contacts, an approach that is not practical or efficient. the almost universal availability of smartphones and other internet active devices (internet of things) makes collecting data from clients practical and efficient. these various data sources provide feedback to providers so that they can predict and prevent relapse and compliance with treatment, especially medication. the authors note that there is not a large body of research in this area, but early studies are positive. one concrete application of ai to providing feedback is described by ryan and his colleagues . their article only describes how such could be done; unfortunately, it is not an actual study but a suggestion on how to apply ai for feedback to physicians to improve their communications with patients. they note that routine assessment and feedback are not done manually because of the cost and time requirements. however, ai can automate these tasks by evaluating recordings. they suggest using already existing ai approaches that are in use by call centers to categorize and evaluate communication along the following dimensions: speaker ratio that indicates listening, overlapping talk that are interruptions, pauses longer than two seconds, speed, pitch, and tone. the content could also be evaluated along the dimensions of the use of plain language, clinical jargon, and shared decision making. ai could also explore other dimensions such as the meaning of words and phrases using nlp, turn taking, tone, and style. many technical difficulties would have to be overcome to assess many of these variables, but the field is making progress. an actual application of ml to feedback, but not in mental health, is provided by pardo et al. ( ) in a course for first-year engineering students. instructors developed in advance a set of feedback messages for levels of interaction with learning resources. for example, different feedback messages were provided depending on whether the student barely looked at video, watched a major portion, watched the whole video, or watched it several times. an ml algorithm selected the appropriate message to send the student through either email or the virtual learning environment. compared to earlier cohorts who did not receive the feedback, those who did were more satisfied with the course and had better performance on the midterm. i can see how such a protocol could be used in mental health services. an indication of the work that needs to be done in becoming more specific about feedback is a study conducted by hooke et al. ( ) . they provide feedback to patients with and without a trajectory showing expected progress and found that patients preferred the feedback with the expected change over time. they found that these patients preferred to have normative feedback with which they could compare their own ideographic progress. two systematic reviews that focused on implementing routine outcome measurement (rom) concluded that while rom has been shown to produce positive results, how to best implement rom remains to be determined by future research (gual-montolio et al. ; mackrill and sorensen ) . the authors of both reviews note several interesting points but focus on these two: how to integrate measurement into clinical practice and how organizations support staff in this effort. they highlight the importance of developing a culture of feedback in organizations. neither review includes any studies using ai. while they call for more research to move this field forward, i do not think there will be much change until either measurement feedback systems are required by funders or service delivery organizations are paid for providing such systems. probably the most advanced work in this area that includes ml is being done by lutz and his colleagues (lutz et al. ) . they have developed a measurement feedback system that includes the use of ml to make predictions and to provide clinicians with clinical decision support tools. they are able to predict dropouts and assign support tools to clinicians that are specific to the problems their clients are exhibiting, based on the data they have collected. lutz and his colleagues are currently evaluating the system to influence clinical outcomes in a prospective study. this comprehensive feedback system provided clinical support tools with recommendations based on identification of similar patients to the treatment group but not to the control group. they already have some very promising results using three different treatment strategies (w. lutz, personal communication, september , ) . almost all the research in this area has been on prediction and not in actually testing whether precision treatments are in fact better than standard treatments in improving mental health outcomes. even these predictive studies are on extant databases rather than data collected specially for use in ai algorithms. with a few exceptions to be discussed later, this is the state of the art. to establish the practical usefulness of ai, we need to move beyond prediction to show actual mental health improvements that have clinical and not just statistical significance. there are some scholars who are carefully considering how to improve methodology to achieve better predictions (e.g., garb and wood ) . in addition, zilcha-mano ( ) has a very thoughtful paper that describes traditional statistical and machine learning approaches to trying to answer the core question of what treatments work best for which patients, as well as the more general question about why psychotherapy works at all. nlp has been used to analyze unstructured or textual material for identifying suicidal ideation in a psychiatric research database. precision of % for identification of suicide ideation and % for suicide attempts has been found using nlp (fernandes et al. ) . a meta-analysis of studies of prediction of suicide using traditional methodologies found only slightly better than chance predictions and no improvement in accuracy in years (franklin et al. b ). recent ml decision support aids using large-scale biological and other data have been useful in predicting responses to different drugs for depression (dwyer et al. ). triantafyllidis and tsanas ( ) conducted a literature review of pragmatic evaluations of nonpharmacological applications of ml in real-life health interventions from january through november , following prisma guidelines. they found only eight articles that met their criteria from citations screened. three dealt with depression and the remainder with other health conditions. six of the eight produced significantly positive results, but only three were rcts. there has been little rigorous research to support ai in real-world contexts. accuracy of prediction is one of the putative advantages of ai. but the advantage of predicting outcomes is not as relevant if a client prematurely leaves treatment. thus, predicting premature termination is one of the key goals of an ai approach. in a pilot study to test whether ai could be beneficial in predicting premature termination, bohus et al. ( ) were not able to adequately predict dropouts using different ml approaches with responses to the borderline symptom list (bsl- ). however, they obtained some success when they combined the questionnaire data with personal diary questionnaires from patients, although they note that the sample is too small to draw any strong conclusions. this pilot study illustrates the importance of what data goes into the data set as well as our lack of knowledge of the data requirements we need to have confidence in as we select the appropriate data. duwe and kim ( ) compared statistical methods including ml approaches on their accuracy in predicting recidivism among , offenders. they found the newer ml algorithms generally performing modestly better. kessler et al. ( ) used data from u.s. army and department of defense administrative data systems to predict suicides of soldiers who were hospitalized for a psychiatric disorder (n = , ). within one year of hospitalization, ( . %) of the soldiers committed suicide. they used a statistical prediction rule based on ml that resulted in a high validity auc value of . . kessler and his colleagues have continued this important work, which was discussed earlier. another approach to prediction was taken by pearson et al. ( ) in predicting depression symptoms after an -week internet depression reduction program using participants. they used an elastic net and random forest ml ensemble (combination) and compared it to a simple linear autoregressive model. they found that the ensemble method predicted an additional % of the variance over the non-ml approach. the authors offer several good technical suggestions about how to avoid some common errors in using ml. moreover, the ml approach allowed them to identify specific module dosages that were related to outcomes that would be more difficult to determine using standard statistical approaches (e.g., detecting nonlinear relationships without having to specify them in advance). however, not all attempts to use ai are successful. pelham et al. ( ) compared logistic regression and five different ml approaches to typical sum-score approaches to identify boys in the fifth grade who would be repeatedly arrested. ml performed no better than simple logistic regression when appropriate cross-validation procedures were applied. the authors emphasize the importance of cross-validation in testing ml approaches. in contrast, a predictive study of people with first-episode psychosis used ai to successfully predict poor remission and recovery one year later based only on baseline data (leighton et al. ) . the model was cross validated on two independent samples. a comprehensive synthesis of the literature of studies that used ml or big data to address a mental health problem illustrated the wide variety of uses that currently exist; however, most dealt with detection and diagnosis (shatte et al. ) . a critical view of the way psychiatry is practiced for the treatment of depression and how ai can improve that practice is provided by tan et al. ( ) . they note that most depression is treated with an "educated-guess-and-check approach in which clinicians prescribe one of the numerous approved therapies for depression in a stepwise manner" (p. ). they posit that ai and especially deep learning have the ability to model the heterogeneity of outcomes and complexity of psychiatric disorders through the use large data sets. at this point, the authors have not provided any completed studies that have used ai, but two of the authors are shareholders in a medical technology company that is developing applications using deep learning in psychiatry. we are beginning to see commercial startups take an interest in mental health services even though the general health market is considerably bigger. entrepreneurially motivated research may be important for the future of ai growth in mental health services, with traditional federal research grants to support this important developmental work, including such mechanisms as the small business innovation research (sbir) program and the r and r nih funding mechanisms. one of the few studies that go beyond just prediction and actually attempt to develop a personalized treatment was conducted by fisher et al. ( ) . in a proof of concept study, the authors used fisher's modular model of cognitive-behavioral therapy (cbt) and algorithms to develop and implement person-by-person treatments for anxiety and mood disorders for adults. the participants were asked to complete surveys four times a day for about days. the average improvement was better than found in comparison benchmark studies. the authors state that this is the first study to use pre-therapy multivariate time series data to generate prospective treatment plans. rosenfeld et al. ( ) describe several treatment delivery approaches that utilize ai. woebot, for example, is a commercial product to provide cbt-based treatment using ai. the clients interact with woebot through instant messaging that is later reviewed by a psychologist. it has been shown to have short-term effectiveness in reducing phq- scores of college students who reported depression and anxiety symptoms. the authors are optimistic that approaches like the ones described will lead to more widely available and efficacious treatment modalities. applications of ml to addiction studies was the focus of a systematic review by mak et al. ( ) . they did an extensive search of the literature until december and could find only articles. none of the studies involved evaluating a treatment. i want to distinguish between the use of computer-assisted therapy, especially that provided through mobile apps, and the use of ai. in a review of these digital approaches to providing cbt for depression and anxiety, wright et al. ( ) point out while many of these apps have been shown to be better than no treatment, they usually do not use ai to personalize them. thus, they are less relevant to this paper and are not discussed in depth. ecological momentary interventions (emis) are treatments provided to patients between sessions during their everyday lives (i.e., in real time) and in natural settings ). these interventions extend some aspects of psychotherapy to patients' daily lives to encourage activities and skill building in diverse conditions. in the only systematic review available of emis, colombo et al. ( ) found only eight studies that used emis to treat major depression, with only four different interventions. the common factor of these four interventions is that they provide treatment in real-time and are not dependent on planned sessions with a clinician. the authors report that participants were generally satisfied with the interventions, but there was variability in compliance and dropout rates among the programs. with only two studies that tested for effectiveness with rcts, there is clearly a need for more rigorous evaluations. momentary reminders are typically used for behaviors such as medication adherence and management of symptoms. the more complex emis use algorithms to optimize and personalize systems. they also can use algorithms that changes the likelihood of the presentation of a particular intervention over time, based on past proximal outcomes. schueller et al. ( ) note that emis are becoming more popular as a result of technological advances. these authors suggest the use of micro-randomized trials (mrts) to evaluate them. an mrt uses a sequential factorial design that randomly assigns an intervention component to each person at multiple randomly chosen times. each person is thus randomized many times. this complex design represents the dynamic nature of these interventions and how their outcomes correspond to different contextual features. ai is often used to develop algorithms to optimize and personalize the mrt over time. one interesting algorithm, called a "bandit algorithm," changes the intervention presented based on a past proximal outcome. as an example, schueller et al. describe a hypothetical study to reduce anxiety through two different techniques-deep breathing and progressive muscle relaxation. the bandit algorithm may start the presentation of each technique with equal frequency but then shift more to the one that appears to be most successful for that individual. thus, each treatment (a combination of deep breathing and progressive muscle relaxation) would be different for each person. unlike rcts, this method does not use group-level outcomes of average effect sizes but uses individual-level data. in the future, we might have personal digital mental health "therapists" or assistants that can deliver individualized combinations of treatments based on algorithms developed with ai that are data driven. of course, this approach is best suited for these momentary interventions and would be difficult if not impossible to successfully apply to traditional treatment. i consider explicating the relationship between ai and causality to be a key factor in understanding whether ai is to be seen as replacing or as supplementing rcts. toward that end, i first consider whether observational data can replace rcts using ai. second, should a replacement not seem currently feasible, i explore ways to design studies that combine ai and rcts to evaluate whether the ai approach produces better outcomes than non-ai enhanced interventions. the journal prevention science devoted a special section of an issue to new approaches for making causal inferences from observational data (wiedermann et al. ). an example is the paper by shimizu ( ) that demonstrates the use of non-gaussian analysis tools to infer causation from observational data under certain assumptions. malinsky and danks ( ) provide an extended discussion of the use of causal discovery algorithms to learn causal structure from observational data. in a similar fashion, blöbaum et al. ( ) present a case for inferring causal direction between two variables by comparing the least-squares errors of prediction in both possible directions. using data that meet some assumptions, they provide an algorithm that requires only a regression in both causal directions and a comparison of the least-square errors. lechner's ( ) paper focuses on identifying the heterogeneity of treatment effects at the finest possible level or identifying what he calls groups of winners and losers who receive some treatment. hassani et al. ( ) hope to build a connection between researchers who use big data analysis and data mining techniques and those who are interested in causality analysis. they provide a guide that describes data mining applications in causality analysis. these include entity extractions, cluster analysis, association rule, and classification techniques. the authors also provide references to studies that use these techniques, key software, substantive areas in which they have been used, and the purpose of the applications. this is another bit of evidence that the issue of causality is being taken seriously and that some progress is being made. however, because of the newness of these publications, there is a lag in publications that are critical of these approaches; for example, d'amour ( ) provides a technical discussion about why some approaches will not work but also suggests that others may be potentially effective. clearly, caution is still warranted in drawing causal conclusion from observational data. chen ( ) provides a very interesting discussion of ai and causality but not from the perspective of the rct issue that i raise here but as a much broader but still relevant point of view. he advances the key question about whether ai technology should be adopted in the medical field. chen argues that there are two major deficits in ai, namely the causality deficit and the care deficit. the causality deficit refers to the inferior ability of ai to make accurate casual inferences, such as diagnosis, compared to humans. the care deficit is the comparative lack of ability of ai to care for a patient. both deficits are interesting, but the one most germane to this paper is the causality deficit. chen notes that ai represents statistical and not causal reasoning machines. he argues that ai is deficient compared to humans in causal reasoning, and, moreover, he doubts that there is a feasible way to deal with this lack of comparability in reasoning. he believes that ai is a model-blind approach in contrast to a human's more model-based approach to causal reasoning. thus, causation for chen is not an issue of experimental methodology (he never mentions rcts in his paper), but a characteristic associated with humans and not computers. chen does recognize that ai researchers are attempting to deal with the causality issue, for example, by briefly describing pearl's ( ) directed acyclic graphs and nonparametric structural equation models. but chen is skeptical that either the causality or care deficits will be overcome. he concludes that ai is best thought of as assisting humans in medical care and not replacing them. the relationship between ai and humans is a major concern of this paper. caliebe et al. ( ) see big data, and i would assume ai, as contributing to hypotheses generation that could then be tested in rcts. the critical issues they see are related to the quality and quantity of big data. they quote an institute of medicine (iom) report that refers to the use of big data and ai in medicine as "learning healthcare systems" and states that these systems will "transform the way evidence on clinical effectiveness is generated and used to improve health and health care" (institute of medicine , p. ). moreover, in , the iom suggested that alternative research methodologies will be needed. they do not acknowledge the conundrum that i have raised here; moreover, they do not see any need to consider changing any of our methodology or analyses. i have found many individual papers that describe how to solve the causality problem with ai (e.g., kuang et al. ; pearl ) . although these papers are complex, their mere existence gives me hope that this problem is being seriously considered. in addition to the statistical and validity issues in trying to replace rcts with observational data, there is the feasibility question. although the data studied in much of the research reported in this paper are in the medical domain and deal primarily with medications, the characteristics of these data have some important lessons for mental health services. bartlett et al. ( ) identified trials published in the top seven highest impact medical journals. they then determined whether the intervention, medical condition, inclusion and exclusion criteria, and primary end points could be routinely obtained from insurance claims and/or electronic health data (ehr) data. these data are recognized by the fda as what they term real-world evidence. they found that only % of the u.s.-based clinical trials published in highimpact journals in could be feasibly replicated through analysis of administrative claims or ehr data. the results suggest that potential for real-world evidence to replace clinical trials is very limited. at best, we can hope that they can complement trials. given the paucity of data collected in mental health settings, the odds are that such data are even less available. suggestions for improving the utility of real-world data for use in research are provided in an earlier article by some of these authors (dhruva et al. ). pearl ( ) posits causal information in terms of the types of questions that, in his three-level model, each level answers. his first level is association; the second, intervention; and the third, counterfactual. association is simply the statistical relationship or correlation. there is no causal information at this first level. the higher order levels can answer questions about the lower levels but not the other way around. counterfactuals are the control groups in rcts. they represent what would have happened if there had been no intervention. to pearl, this unidirectional hierarchy explains why ml, based on associations, cannot provide causal statements like rcts, which are based on counterfactuals. however, as noted earlier, pearl does present an approach using what he calls structural causal models to "extract" causal relationships from associations. pearl describes seven "talks" and accompanying tools that are accomplished in the framework provided by the structural causal models that are necessary to move from the lower levels to the counterfactual level to allow causal inferences. i would anticipate that there will be direct comparisons between this approach to causality and the randomized experiments like those done in program evaluation (bickman and reich ; boruch et al. ) . theory development or testing is usually not thought of as a strength of ai; instead, its lack of transparency, that is, the lack of explanatory power that would enable us to identify models/mechanisms that underlie outcomes, is seen as a major weakness. coutanche and hallion ( ) present a case for using feature ablation to test theories. this technique involves the removal or ablation of features from algorithms that have been thought to be theoretically meaningful and then seeing if there is a significant reduction in the predictive accuracy of the model. they have also studied whether the use of a different data set affects the predictive accuracy of a previously tested model in theoretically useful ways. they present a very useful hypothetical application of their approach to test theories using ai. it is clear that ai can be very useful in making predictions, but can it replace rcts? can ai perform the major function of rcts, that of determining causality? the dependence on rcts was one of the major limitations i saw as hindering the progress of mental health services research. while rcts have their flaws, they are still considered by most as the best method for determining causal relationships. is ai limited to being a precursor in identifying those variables that are good candidates for rcts because they have high predictive values? the core conceptual problem is that while it is possible to compare two different but theoretically equivalent groups, one receiving the experimental treatment and the other the control condition, it is not possible to compare the same individuals on both receiving and not receiving the experimental treatment. rcts produce average effect sizes, but the ultimate purpose of precision mental health is to predict individualized effects. how do we reconcile these two very different aims? one approach is to use ai to identify the most predictive variables and then test them in a randomized experiment. let us take a group of patients with the same disorder or problem. there may be several alternative treatments, but the most basic concept is to compare two conditions. in one condition, call it the traditional treatment condition in the rct, everyone in that condition gets the same treatment. it is not individualized. in the second condition, call it the ai condition, everyone gets a treatment that is based on prior ai research. the latter may differ among individuals in dosage, timing, type of treatment, and so on. the simplest is medication that differs in dosage. however, a more nuanced design is a yoked design used primarily in operant and classical conditioning research. there have been limitations associated with this design, but these problems apply to conditioning research and not the application considered here (church ) . to separate the effects of the individualization from the differences in treatment, i suggest using a yoked design. in this design, individuals who would be eligible to be treated with either the standard treatment or the ai-selected treatment would be yoked, that is, paired. which participant of the pair received which condition would be randomized. first, the eligible participants would be randomly divided into two groups. the individuals in the ai group would get a treatment that was precisely designed for each person in that group, while those in the yoked control group would not; instead, those in the control group would receive the treatment that had been designed for his or her partner in the ai group. in this way, each participant would receive the same treatment, but only the ai group participants would be receiving individualized treatment. if the ai approach is superior, we would expect those in the ai group to have a superior average treatment effect compared to the control group, who received a treatment matched not to their individual characteristics but to those in the ai group. we could also use an additional control group where the treatment is selected by a clinician. while this design would not easily identify which characteristics were responsible for its success, it would demonstrate whether individualized ai-based treatment was the causal factor. that is, we could learn that on the average, a precision approach is more effective than a traditional approach, but we would not be able to identify from this rct which particular combination of characteristics made it more effective. of note is that the statistical power of this design would depend on the differences among the participants at baseline. for example, if the individuals were identical on measured covariates, then they would get the same personalized treatment, which practically would produce no useful information. instead of yoking participants based on randomly assigning them as in the above example, we could yoke them on dissimilarity and then randomly assign each individual in the pair to ai-based treatment or a control condition that could be the same ai treatment or a clinician-assigned treatment. however, interesting this would be from a methodical point of view, i think this would also bring up ethical issues that are discussed next. of course, as with any rct, there are ethical issues to consider. in many rcts, the control group may receive standard treatment, which should not present any unusual ethical issues. however, in a yoked design, the control group participants will receive a treatment that was not selected for them on the basis of their characteristics. moreover, the yoked design would make the formulation of the informed consent document problematic because it would have to indicate that participants in the control group would receive a treatment designed for someone else. one principle that should be kept in mind is equipoise: there should be consensus among clinicians and researchers that the treatments, a priori, are equivalent. in a yoked design, we must be assured that none of individualized treatments would harm the yoked control group members, and moreover, that there is no uniform agreement that the individualized treatment would be better for the recipient. that is, the research is designed to answer a question about relative effectiveness for which we do not know the answer. almost all of the research previously cited in this paper has dealt with psychosocial interventions, along with some research on interventions with medications. clearly these are the two main approaches taken in providing services for mental health problems. however, in the last decade, a new approach to understanding mental illness has emerged from the field of psychoneuroimmunology. this relatively new field integrates research on psychology, neuroscience, and immunology to understand how these processes influence each other and, in turn, human health and behavior (slavich ). i want to explore this relatively new approach to understanding mental health because i believe that it is a potentially rich field in which to apply ai. slavich and irwin ( ) have combined diverse areas to show how stressors affect neural, physiologic, molecular, and genomic and epigenetic processes that mediate depression. they labeled this integrative theory the social signal transduction theory of depression. in a recent extension of this work, slavich ( ) proposed social safety theory, which describes how social-environmental stressors that degrade experiences of social safety-such as social isolation and rejection-affect neural, immunologic, and genomic processes that increase inflammation and damage health. a key aspect of this perspective is the role of inflammatory cytokines as key mediators of the inflammatory response (slavich ) . cytokines are the biological endpoint of immune system activity and are typically measured in biobehavioral studies of stress and health. cytokines promote the production of c-reactive protein, which is an inflammatory mediator like cytokines, but which also is a biomarker of inflammation that is assessed with a blood test. cytokines also interact with the central nervous system and produce what have been labeled "sickness behaviors," which include increased pain and threat sensitivity, anhedonia, fatigue, and social-behavioral withdrawal. while the relationship between inflammation and depression is well-established in adults, a systematic review and meta-analysis of studies with children and adolescents concluded that because of the small number of studies, more evidence was needed before drawing a similar conclusion for youth (d'acunto et al. ) . in contrast, a major longitudinal study of more than adults followed over years found that participants who had stable high c-reactive protein levels were more likely to report clinically significant late-life depression symptoms (sonsin-diaz et al. ) . chronic inflammation has been shown to be present in many psychiatric disorders including depression, schizophrenia, and ptsd, as well as in many other somatic and physical disease conditions (furman et al. ) . chronic inflammatory diseases have been shown to be a major cause of death. a typical inflammatory response occurs when a threat is present and then goes away when there is no longer a threat. however, when the threat is chronic and unresolved, systemic chronic inflammation can occur and is distinct from acute inflammation. chronic inflammation can cause significant damage to tissues and organs and break down the immune system tolerance. what is especially interesting from a behavioral health perspective is that inflammatory activity can apparently be initiated by any psychological stressor, real or imagined. thus, social and psychological stressors such as negative interpersonal relationships with friends and family, as well as physical stressors, can produce inflammation, which leads to increased risk of mental and physical health problems. this inflammatory response initially can have positive effects in that it can help increase survival in the short term, but it can also lead to a dysfunctional hypervigilance and anxiety that increases the risk of serious mental illness if chronic. the "cytokine storm" experienced by many covid- patients is an example of the damage an uncontrolled immune response can cause (konig et al. ). although we do not know a great deal about how this process operates, it is clear that there is a strong linkage between inflammatory responses and mental disorders such as depression. the role of the immune system in disease, especially brain inflammation related to brain microglial cells (i.e., neuroinflammation), is also receiving attention in the popular press (nakazawa ). psychoneuroimmunology research has explicated the linkage between the brain and the immune system, showing how stress affects the immune system, and how these interactions relate to mental illness. the relationships between these constructs suggest interventions that can be used to improve mental health. but much research remains to be done to identify specific processes and effective interventions. research will require multidisciplinary teams to produce personalized interventions guided by each patient's specific level of neuroinflammation and genetic profiles. this process will need to be monitored by continuous feedback that i believe will be made more feasible with the application of ai. at present, there are some existing interventions that appear to be aligned with this approach that are being explored. these include the following. three anti-inflammatory medications have been found to reduce depressive symptoms in well-designed rcts. these agents include celecoxib, usually used for treating excessive inflammation and pain, and etanercept and infliximab, which are used to treat rheumatoid arthritis, psoriasis, and other inflammatory conditions (slavich ) . however, there has not been a great deal of research in this area, so caution is warranted. a recent well-designed rct with depressed youth tested aspirin, rosuvastatin (a statin), and a placebo and found no significant differences in depression symptoms (berk et al. ). a meta-analysis explored the possible link between different types of psychosocial interventions, such as behavior therapy and cbt, and immune system function (shields et al. ) . the authors examined eight common psychosocial interventions, seven immune outcomes, and nine moderating factors in evaluating rcts. they found that psychosocial interventions were associated with a . % improvement in good immune system function and a . % decrease in detrimental immune function, on average. moreover, the effects lasted for at least months and were consistent across age, sex, and intervention duration. the authors concluded that psychosocial interventions are a feasible approach for influencing the immune system. repetitive transcranial magnetic stimulation (rtms) has been found to be an effective treatment for several mental illnesses, especially treatment-resistant depression (mutz et al. ; somani and kar ; voigt et al. ) . while the literature is not clear on how rtms produces its effect (noda et al. ; peng et al. ) , i was curious about its relationship to neuroinflammation. i could find little in the research literature that addressed the relationship between inflammation and rtms; therefore, i conducted an informal survey of rtms researchers who have published rtms research in peer-reviewed journals and asked them the following: i suspect that rtms is related to inflammation but the only published research that i could find on that relationship was two studies dealing with rats. are you aware of any other research on this relationship? in addition, do you know of anyone using ai to investigate rtms? i received replies from all but of the researchers. about half said they were aware of some research that linked rtms to inflammation and supplied citations. in contrast, only % were aware of any research on rtms and ai. the latter noted some research that used ai on eegs to predict rtms outcomes. a most informative response was from the author of a review article that dealt with several different nontraditional treatments including rtms on the hypothalamic-pituitary-adrenal (hpa) axis and immune function in the form of cytokine production in depression (perrin and parianti ) . the authors found relevant human studies ( studies using rtms) but were unable to conduct the metaanalysis because of significant methodological variability among studies. but they concluded that non-convulsive neurostimulation has the potential to impact abnormal endocrine and immune signaling in depression. moreover, given that there is more information available than on other neurostimulation techniques, the research suggests that rtms appears to reduce cytokines. finally, there is some support from animal models (rats) that rtms can have an anti-inflammatory effect on the brain and reduce depression and anxiety (tiana et al. ). moreover, four published studies showed that the efficacy of rtms for schizophrenics could be predicted koutsouleris et al. ( b) . three other studies were able to use ml and eeg to predict outcomes of rtms treatment for depression (bailey et al. ; hasanzadeh et al. ) . the existing literature indicates that metabolic activity and regional cerebral blood flow at the baseline can predict the response to rtms in depression (kar ) . as these baseline parameters are linked to inflammation, it is worth studying responses to rtms that predict inflammation. as noted by one of the respondents, "in summary, it is a relatively new field and there are no major multi-site machine learning studies in rtms response prediction" (n. koutsouleris, personal communication, march , ) . one of the significant limitations of measurement in mental health is the absence of robust biomarkers of inflammation. furman et al. ( ) caution us that "despite evidence linking sci [systemic chronic inflammation] with disease risk and mortality, there are presently no standard biomarkers for indicating the presence of health-damaging chronic inflammation" (p. ). however, some biomarkers that are currently being explored for inflammation may be of some help. for example, furman et al. ( ) are hopeful that a new approach using large numbers of inflammatory markers to identify predictors will produce useful information. a narrative review of inflammatory biomarkers for mood disorders was also cautious in drawing any conclusions from extant research because of "substantial complexities" (chang and chen ) . it is also worth noting the emerging area of research on gut-brain communication and the relationship between microbiome bacteria and quality of life and mental health (valles-colomer et al. ) . however, there is need for more research on the use of biomarkers. the area of inflammation and mental health offers an additional pathway to uncovering the causes of mental illness but also, most importantly for this paper, potential services interventions beyond traditional medications and psychosocial interventions. given the complexity, large number of variables from diverse data sets, and the emerging nature of this area, it appears that ai could be of great benefit in tying some potential biomarkers to effective interventions designed to produce better clinical outcomes. however, some caution is needed concerning the seemingly "hard data" provided by biomarkers. for example, elliot et al. ( ) found in a meta-analysis of experiments that one widely used biomarker, task-fmir, had poor overall reliability and poor test-retest reliability in two other large studies. they concluded that these measures were not suitable for brain biomarker research or research on individual differences. as noted in several places in this paper, ai is not without its problems and limitations. the next section of the paper discuses several of these problems. ai may force the treatment developer to make explicit choices that are ethically ambiguous. for example, automobile manufacturers designing fully autonomous driving capabilities now have to be explicit about whose lives to value more in avoiding a collision-the driver and his or her passengers or a pedestrian. should the car be programmed to avoid hitting a pedestrian, regardless of the circumstances, even if it results in the death of the driver? mental health services do not typically have such clear-cut conflicts, but the need to weigh the potential side effects of a drug against potential benefits suggests that ethical issues will confront uses of ai in mental health. some research has shown that inherent bias in original data sets has produced biased (racist) decisions (obermeyer et al. ; veale and binns ) . an unresolved question is who has the responsibility for determining the accuracy and quality of original data set (packin and lev-aretz ) . data scientists operating with data provided by others may not have sufficient understanding of the complexity of the data to be sensitive to its limitations. moreover, they may not consider it their responsibility to evaluate the accuracy of the data and attend to its limitations. librenza-garcia ( ) provides a comprehensive review of ethical issues in the use of large data sets with ai. the ethical issues in predicting major mental illness are discussed by lawrie et al. ( ) . they note that predictive algorithms are not sufficiently accurate at present, but they are progressing. the authors raise questions about whether people want to know their risk level for major psychiatric disorders, about individual and societal attitudes to such knowledge and the possible adverse effects of sharing such data, and about the possible impact of such information on early diagnosis and treatment. they urge conducting research in this area. related to the ethics issue but with more direct consequences to the health provider is the issue of legal responsibility in using an ai application. it is not clear what the legal liability is for interventions based on ai that go wrong. who is responsible for such outcomes-the person applying the ai, the developer of the algorithm, or both? price ( ) points out that providers typically do not have to be concerned about the legal liability of a negative outcome if they used standard care. thus, if there are negative outcomes of some treatment but that treatment was the standard of care, there is usually no legal liability. however, currently ai is probably not seen as the standard of care in most situations. while this will hopefully change as evidence of the effectiveness of ai applications develops, currently the healthcare provider is at greater risk of legal liability in using an ai application that is different from the standard of care. i have previously discussed the insufficient evidence for the effectiveness of many of the interventions used in mental health services. this lack of strong evidence has implications for the use of ai in mental health services. in an insightful article on using ai for individual-level treatment predictions, paulus and thompson ( ) make several key observations and suggestions that are very relevant to the current paper. the authors summarize several meta-analyses of the weak evidence of effectiveness of mental health interventions and come to conclusions similar to those i have already stated. they also identify similar factors i have focused on in accounting for the modest effect sizes found in mental health rcts. they point out that diagnostic categories are not useful if they are not aggregating homogenous populations. they suggest that what i call the diagnostic muddle may result from the nature of mental disorders themselves, for which there are many causes at many different levels, from the genetic to the environmental. thus, there is no simple explanatory model. paulus and thompson note that prediction studies rarely account for more than a very small percentage of the variance. they recommend conducting large, multisite pragmatic rcts that are clearly pre-defined with specific ml models and variables. predictive models generated by this research then need to be validated with independent samples. this is a demanding agenda, but i think it is necessary if we are going to advance mental health services with the help of ai. treatments are often considered black boxes that provide no understanding of how and why the treatment works (kelley et al. ; bickman b) . the problem of lack of transparency is compounded in the use of deep neural networks (samek et al. ) . at present we are not able to understand relationships between inputs and outcomes, because this ai technique does not adequately describe process. deep neural networks may contain many hidden layers and millions of parameters (de choudhury and kikkoman ). however, this problem is now being widely discussed, and new technologies are being developed to make ai more transparent (rauber et al. ; kuang et al. ). i do not believe it is possible to develop good theories of treatment effectiveness without this transparency. this is an important limitation of efforts to improve mental health services. but how important is this limitation? early in my program evaluation career, i wrote about the importance of program theory (bickman (bickman , . i argued that if individual studies were going to be conceptually useful, beyond local decisions such as program termination, then they must contribute to the broader goal of explaining why certain programs were effective and others not. this is in contrast to the worth and merit of a local program. a theory based evaluation of the program must add to our understanding of the theory underlying the program. while i still believe that generalizing to a broad theory of why certain interventions work is critical, at present it may be sufficient simply to increase the accuracy of our predictions, regardless of whether we understand why. as stephens-davidowitz ( ) argues, "in the prediction business, you just need to know that something works, not why" (p. ). however, turing award winner judea pearl argued in his paper theoretical impediments to machine learning with seven sparks from the causal revolution ( ) that human-level ai cannot emerge from model-blind learning machines that ignore causal relationships. one of the positive outcomes of the concern over transparency is the development of a subfield of ai that has been called explainable artificial intelligence (xai). adai and berrada ( ) present a very readable description of this movement and show that it has been a growing area since . they are optimistic that research in this area will go a long way toward solving the black box problem. large data sets are required for some ai techniques, especially deep neural networks. while such data sets may be common in consumer behavior, social media, and hospitalbased electronic health records, they are not common in community-based mental health services. the development and ownership of these data sets may be more important (and profitable) than ownership of specific ai applications. there is currently much turmoil over data ownership (mittelstadt ) . ownership issues are especially important in the mental health field given the sensitivity of the data. in addition to the size and quality of the data set, longitudinal data are necessary for prediction. collecting longitudinal data poses a particular problem for community-based services given the large treatment drop-out rate. in addition to the characteristics of the data, there is the need for competent data managers of large complex data sets. the data requirements for mental health applications are more demanding than those for health in general. first, mental health studies usually do not involve the large samples that are found in general health. for example, the wellknown physicians' health study of aspirin to prevent myocardial infarction (mi) utilized more than , doctors in a rct (steering committee of the physicians' health study research group ). they found a reduction in mi that was highly statistically significant: p < . . the trial was stopped because it was thought that this was conclusive evidence that aspirin should be adopted for general prevention. however, the effect size was extremely small: a risk difference of . % with r = . (sullivan and feinn ) . a study this size is not likely to occur in mental health. moreover, such small effects would not be considered important even if they could be detected. it is unlikely that very large clinical trials such as the aspirin study would ever be conducted in mental health. thus, it is probable that data will have to be obtained from service data. but mental health services usually do not collect sufficiently fine-grained data from clients. while i was an early and strong proponent of what i called a measurement feedback system for services (bickman a) , recent research shows that the collection of such data is rare in the real world. until services start collecting these data as part of their routine services, it is unlikely that ai will have much growth with the limited availability of relevant data. there is, of course, a chicken and egg problem. a major reason why services do not collect data is the limited usefulness of data in improving clinical care. while ai may offer the best possibility of increasing the usefulness of regularly collected data, such data will not be available until policy makers, funders, and providers deem it useful and are willing to devote financial resources to such data collection analysis. at present, there are no financial incentives for mental health providers to collect such data even if they improved services. moustafa et al. ( ) made the interesting observation that psychology is behind other fields in using big data. ai and big data are not considered core topics in psychology. the authors suggest several reasons for this, including that psychology is mostly theory-and hypothesis-driven rather than data-driven, and that studies use small sample sizes and a small number of variables that are typically categorical and thus are not as amenable to ai. moreover, most statistical packages used by psychologists are not well-equipped to analyze large data sets. however, the authors note that the method of clustering and thus differentiating among participants is used by psychologists and is in many ways similar to ai, especially deep neural networks, in trying to identify similar participants. using ml methods such as random forest algorithms, the investigator can identify variables that best explain differences among groups or clusters. instead of the typically few variables used by psychologists, ai can examine hundreds of variables. as a note of caution, rutledge et al. ( ) warn that "there is no silver bullet that can replace collecting enough data to generate stable and generalizable predictions" (p. ). while there are techniques that are often used in low sample size situations (e.g., the elastic net and tree-based ensembles), researchers need replications with independent samples if they are to have sufficient confidence in their findings. moreover, since big data are indeed big, they are easily misunderstood as automatically providing better results through smaller sampling errors. it is often not appreciated that the gain in precision drawn from larger samples may well be nullified by the introduction of additional population variance and biases. finding competent big data managers, data scientists, and programmers is a human resource problem. in my experience, ai scientists who are able and want to collaborate with mental health services researchers are rare. industry pays a lot more for these individuals than universities can afford. moreover, even within the health field, mental health is a very small component of the cost of services, so it is often ignored in this area. difficulty and resistance are encountered in the implementation of new technologies. clinicians are reluctant to adopt new approaches and to engage clients in new approaches and data collection procedures. community mental health services have been slow to successfully adopt new technologies (crutzen et al. ; lattie et al. ; yeager and benight ) . in their mixed methods study of community clinicians, crutzen et al. ( ) found there were concerns about privacy, the wide range of therapeutic techniques used, disruptions in trust and alliance, managing crises, and organizational issues such as billing and regulations contained in the privacy rule established by the health insurance portability and accountability act of (hipaa) that inhibited the use of new technologies. moreover, our current reimbursement policies do not support greater payment for better outcomes. thus, there is little or no financial incentive for hard-pressed community services to improve their services at their own expense. in fact, i would argue that there is a disincentive to improve outcomes since it results in increased costs (at least initially), organizational disruption and potentially a loss of clients if it takes less time and effort to successfully treat them. an interesting meta-issue has emerged from the widespread and ever-increasing investment in ai in healthcare. in a perceptive "viewpoint" published in jama, emanuel i would be happy to serve as a "matchmaker" for any ai programmers, data scientists (etc.), or behavioral scientists who are interested in collaborating on mental health projects. just contact me describing your background and interests and i will try to put together likeminded researchers. and wachter ( ), argue that the major challenge facing healthcare is not that of obtaining data and new analytics but the achievement of behavior change among both clinicians and patients. they point out the major failures of google and microsoft in not recognizing the problems in translating evidence into practice in connection with their large, web-based repositories for storage of health records, google health and microsoft healthvault, both of which have been discontinued. they indicate that the long delays in translation are due not primarily to data issues or lack of accurate predictions, but to the absence of behavioral changes needed for adoption of these practices. for example, the collection of longitudinal data has been problematic. another problem they note is that about half the people in the united states are nonadherent with medications. there is a huge gap between knowing what a problem is and actually solving it that "data gurus" seem to ignore. while this translation problem is evident in the sometimes narrow focus of ai promoters, it also represents an opportunity for the behavioral scientists engaged in ai research to marshal their skills and the knowledge gained from years of dealing with similar behavioral issues. the emergence of translational and implementation sciences, the latter more often led by behavioral scientists, can be of great service to the problems of applying ai to healthcare. the field of translational sciences has been developed and well-funded by the nih in recognition of the difficulty in using (i.e., translating) laboratory studies into practice. in , the budget for the clinical and translational science awards (ctsa) program was over a half billion dollars from to . however, as director of evaluation for vanderbilt's medical center's ctsa program for many years, i became very familiar with the difficulties in applying medical research in the real world. mental health is determined by multiple factors. it is unlikely that we will find a single vector such as a virus or a bacterium that causes mental illness. thus, data demands can include multiple systems with biological, psychological, sociological, economic, and environmental factors. within many of these domains, we do not have objective measures such as the lab tests found in medicine. subjective selfreports are prone to many biases, and many of the symptoms are not observable by observers. the lack of a strong theory of mental disorders also makes it difficult to intelligently focus on only a few variables. even with such apparently simple measures that include observations or recordings from multiple informants, we do not have a consensus on how to integrate them (bickman et al. a; martel et al. ). however, i would expect that research generated with ai will contribute not only to improved treatment but also to enhanced theories by including heterogeneous clients and many data sources. confidentiality and trust are key issues in mental health treatment. how will the introduction of ai affect the relationship between client and clinician? as noted earlier, there are problems, especially with deep learning, in interpreting the meaning of algorithmic solutions and predictions. our ability to explain the algorithms to clients is problematic. while many research projects outside of mental health show that combining ai with human judgment produces the best outcomes, this research is still in its infancy. a great deal has been written about ai in the context of medicine, but we need a reality check about the importance of ai in clinical practice. ben-israel et al. ( ) addressed the use of ai in a systematic review of the medical literature from to . the authors focused on human studies that addressed a problem in clinical medicine using one or more forms of ai. of the studies, only % were prospective. none of the studies included a power analysis, and half did not report attrition data. most were proof of concept studies. the authors concluded that their study showed that the use of ai in daily practice of clinical medicine is practically nonexistent. the authors acknowledge that use was defined by publication and that many applications of ai may be occurring without publication. regardless, this study suggests that there are many barriers that must be overcome before ai is more widely used. the self-help industry can provide perspective on digital apps, including some that use ai. it has been estimated that this sector was worth $ . billion in and is expected to be worth $ . billion in (la rosa ). part of that big dollar market is in digital mental health apps, although their precise monetary value is unknown. more to the point is that we know little about the effectiveness of digital apps in the marketplace (chandrashekar ) . moreover, many have warned that these unregulated and untested apps could be dangerous (wykes ) . in the united states, the publication of books is protected by the constitution, so there are no rules governing what can be published in the self-help sector. the market determines what gets accepted and used, regardless of effectiveness or negative side effects. but publication is limited by the cost of publishing and distribution. this is not the case for digital programs, where marginal costs of adding an additional user are negligible. unlike other mental health interventions, there are no licensing or ethical standards governing their use. there are no data being uniformly collected on their use and their effects. although there are u.s. government rules that can be applied to these apps (armontrout et al. ) , the law has many exceptions. the authors note that they could not find a single lawsuit related to software that diagnoses or treats a psychiatric condition. an interactive tool is provided by the federal trade commission to help judge which federal laws might apply in developing an app (https ://www.ftc.gov/tips-advic e/busin ess-cente r/guida nce/mobil e-healt h-apps-inter activ e-tool). it is clear that digital mental health apps will continue to grow. it is critical that services research and funding agencies do not overlook this development that might have potentially positive or negative effects. these are but a few of the many areas or ai needing additional research and potential limitations to be addressed. an excellent discussion of these and other relates issues regarding the potential hype common in the ai field is provided in the national academy of medicine's monograph on the use of ai in healthcare (matheny et al. ) . a thought-provoking paper by hagendorff and wezel ( ) classifies what ai can and cannot do. some of the authors' concerns, such as measurement, completeness and quality of the data, and problems with transparency of algorithms, have already been discussed, so i will describe those that i feel are most relevant to mental health services. the authors describe two methodological challenges, the first being that the data used in ai systems are not representative of reality because of the way they are collected and processed. this can lead to biases and problems with generalizability. second is the concern that supervised learning represents the past. thus, prediction can be based only on the past and not on expectations of change; thus, in some respects, change is inhibited. hagendorff and wezel ( ) also note several societal challenges. one such challenge they cite is that many software engineers who develop these algorithms do not have sufficient knowledge of the sociological, psychological, ethical, and political consequences of their software. they suggest this leads to misinterpretations and misunderstandings about how the software will operate in society. the authors also note the scarcity of competent programmers. i noted earlier that this is especially the case in academia and particularly in the behavioral sciences. the authors highlight that ai systems often produce hidden costs. this includes hardware to run the ai systems and, i would add, the disruptive nature of the intrusion of ai into a workflow. among the technological challenges discussed by hagendorff and wezel, i believe the authors' focus on the big differences between human thinking and intelligent machines is especially relevant to mental health. machines are in no way as complex as human brains; even ai's powerful neural networks, with more than a billion interconnections, represent only a tiny portion of the complexity of brain tissue. in order to obtain better convergence between machines and humans, hagendorff and wezel suggest that programmers follow the three suggestions made by lake et al. ( ) . first, programmers should move away from pattern recognition models, where most development started, to automated recognition of causal relationships. the second suggestion is to teach machines basic physical and psychological theories so that they have the appropriate background knowledge. the third suggestion is to teach machines to learn how to learn so that they can better deal with new situations. the comparison between ai and human thought is the only aspect of their paper where hagendorff and wezel mention causality issues. they note the challenge related to the inflexibility of many algorithms, especially the supervised ones, where simply changing one aspect would result in processing errors because that aspect was not in the training data. machines can be vastly superior to humans in some games where there are very specific inputs for achieving specific goals, but they cannot flexibly adapt to changes like humans. the authors suggest that promising technical solutions are being worked on to deal with this weakness in transferability. all these challenges will affect how well ai will work in mental health services. most problems will probably be solved, but the authors believe that some of these challenges will never be met, such as dealing with the differences between human and computer cognition, which means that ai will never fully grasp the context of mental health services. the machine's construction of a person may lead to a fragmented or distorted self-concept that conflicts with the person's own sense of identity, which seems critical to any analysis of the person's mental health or lack thereof. i do not have a sense of how serious this and the other challenges will be for us in the future, but it is clear that there is a lot more we need to learn. yet another set of concerns, specifically about the variation in ai called deep learning (dl), was enumerated by marcus ( ) , an expert in dl. in a controversial paper in which he identified limitations of dl, he noted that dl "may well be approaching a wall" (p. ) where progress will slow or cease. for example, he noted that dl is primarily a statistical approach for classifying data, using neural networks with multiple layers. dl "maps" the relationships between inputs and outputs. while children may need only a few trials to correctly identify a picture of a dog, dl may need thousands or even millions of labeled examples before making correct identifications without the labels. very large data sets are needed for dl. this is not the case for all ml techniques. i will not attempt to summarize the nine other limitations he sees with dl since many of them are noted elsewhere in this paper. he concludes that dl itself is not the problem; rather, the problem is that we do not fully understand the limitations of dl and what it does well. marcus warns against excessive hype and unrealistic expectations. i am taking this advice personally, and i am not expecting my tesla to be fully autonomous in as predicted by elon musk (woodyard ) . wolff ( ) provided an overview of how some of the problems of deep learning can be ameliorated. he responds to marcus using many of the subheadings in marcus's paper. he calls his framework the sp theory of intelligence, and its application is called the sp computer model (sp stands for simplicity and power). the theory was developed by wolff to integrate observations and concepts across several fields including ai, computing, mathematics, and human perception and cognition, using information compression to unify them. despite these and other concerns previously described, i do think that the advantages of ai for moving mental health services forward outweigh its disadvantages. however, this summary of advantages does not attempt to balance in length or number the disadvantages described above. i do not think it is necessary to repeat the already described numerous applications and potential applications of ai that can be used to improve health services. rather than repeating the numerous applications and potential applications of ai that can be used to improve health services, i highlight only a few key advantages. one of the main advantages is the way ai deals with data. it can handle large amounts of data from diverse sources. this includes structured (quantitative) and unstructured (text, pictures, sound) data in the same analyses. thus, it can integrate heterogeneous data from dissimilar sources. as noted earlier, the inclusion of non-traditional data such as those obtained from remote sensing (e.g., movement, facial expression, body temperature) will be responsible for a paradigm shift in what we consider relevant data. ai, if widely adopted, has the potential to have a major impact on employment. while most of the popular press coverage has been on the potential negative effects of eliminating many jobs, there also are potential positive effects. ai can reduce the costs of many tasks, thus increasing productivity. on the human side, it can streamline routine work and eliminate many boring aspects of work. it thus can free up workers to engage in the more complex and interesting aspects of many jobs. previous innovations have caused job dislocations. the classic loss of jobs in making buggy whips after the advent of automobiles is just one example. the inventions of the industrial age, such as steam engines, displaced many workers but also created many more new jobs. we know that many unskilled or semi-skilled jobs will be affected by ai in a major way. the elimination of cashiers with automated checkouts is now being implemented by amazon. in these stores, you scan your phone, and then ai and cameras take over. you just put products in your bag or cart and leave when you are finished. self-driving cars and trucks will greatly disrupt the transportation industry. we have weathered these disruptions in the past, but even the experts are unsure about how ai will influence jobs. probably the area in which there is the most positive potential in healthcare is when humans and machines collaborate in partnership. here, ai augments human tasks but keeps humans in the center. thus, physicians will no longer be separated by a laptop when speaking to a patient because ai will be able to record, take notes, and interpret the medical visit. we have documented the shortage of mental health workers and the immense gap between mental health needs and our ability to fill them. yes, we can train more clinicians, but our society seems unwilling to offer sufficient salaries to attract and keep such individuals. we have been experimenting with computers as therapists for more than years, but now we finally have the technological resources to develop and implement such approaches. we have started to use chatbots to extend services, but in the near future, ai may allow us to replace the human therapist under some conditions (hopp et al. ). in , the computer scientist and science fiction author vernor vinge developed the concept of a singularity in which artificial intelligence would lead to a world in which robots attain self-consciousness and are capable of what are now human cognitive activities (vinge ) . advocates and critics disagree on whether a singularity will be achieved and whether it would be a desirable development (braga and logan ) . braga and logan, editors of a special issue of information on the singularity and ai, conclude that although ai research is still in the early stage, the combination of human intelligence and ai will produce the best outcomes, but ai will never replace humans and we cannot fully depend on ai for the right answers. while these authors are well-informed, their crystal ball may not be clearer than anyone else's. the relevance of the singularity for healthcare lies in asking whether there will there be a time when ai-based computers are more effective and efficient than clinicians and will replace them. it is a question worth considering. i have presented a comprehensive, wide-ranging paper dealing with ai and mental health services. i have described major deficiencies of our current services, namely the lack of sufficient access, inadequate implementation, and low efficiency/effectiveness. i summarized how precision medicine and ai have contributed to improving healthcare in general and how these approaches are being applied in precision psychiatry and mental health. the paper then describes research that shows how ai has been or can be used to help solve the five problems i noted earlier. i then described the disadvantages and advantages of ai. in reviewing all this information, i believe there is one factor that i have not discussed sufficiently that clearly differentiates the way mental health services have been delivered and the way i expect they will be delivered in the future. i want to focus this last section of the paper on what i believe is the most important and significant change that can occur. this change is reflected in a simple question: is a human clinician necessary to deliver effective and efficient mental health services? i believe the answer to this question does not depend on the occurrence of the singularity but lies in the growth of ai research and its application to mental health services. i think there is widespread agreement that there are significant problems with diagnoses and the quality of our measures. moreover, most will probably agree that if ai can improve diagnoses and measures, then we should use utilize ai and let the results speak for themselves. the dependence on rcts will probably not be resolved by ai research, but ai can clearly help inform what should be tested in rcts. however, our current services overwhelmingly depend on human clinicians to deliver treatment. the problem with learning and feedback is that it requires clinicians to learn how to improve treatment over time with feedback. we are still uncertain about how well clinicians can learn from experience, training, and education (bacon ) . we also lack evidence of the best way to provide feedback to enhance that learning (bickman a; dyason et al. ). the problem of treatment precision is also currently tied to having the clinician deliver the treatment. while we can expect ai to deliver more precise information about treatment planning, we still depend on the clinician to interpret and deliver it with fidelity with some evidence-based model. a precision approach requires the clinician to systematically deliver treatment that is most appropriate to a specific client. we do not have good evidence that most clinicians can do that. i believe no other issue generates a bigger emotional response than the idea of the changing the role of the clinician. no other issue has the economic impact on services as the position of the clinician. i believe this issue is the most critical to the future of mental health services and will be most affected by ai. i note that in in writing an introduction to an extensive special issue of this journal called "therapist effects in mental health service outcome" (king ) , the authors of the introduction to that issue not did not note the potential role of ai in affecting clinicians (king and bickman ) . change is happening rapidly. mental health services are not alone in facing the issue of the role of humans, although human clinicians are probably more central to the provision of mental health services than other health services. a similar issue of the role of humans in the provision of services is being played out in surgery. surgery has been using robots for over years (bhandari et al. ), but the uptake has been slow for a variety of reasons. the next iteration of robot use is a move from using robots guided by surgeons to using robots assisted by ai and guided by surgeons. the use of ai may be seen as an intermediate step to fully autonomous ai-based robots not guided by surgeons. however, it is very clear that this progression is speculative and will take a long time to happen, if ever, given the consequences of errors. closer to our everyday experience is the similar path that the development of autonomous driving involves as we move toward the point at which a human driver is no longer needed. will mental health services follow a similar path? since we do not currently have a sufficient amount of research on using ai in treatment alone to inform us, we must look elsewhere for guidance. two bodies of literature are relevant. one deals with the use of computers and other technologies that do not include the use of ai at present, the second with self-help in which the participation of the clinician is minimal or totally absent. first, let us consider the existing literature that contrasts technology-based treatments with traditional face-to-face psychotherapy. then i will present some reviews of self-help research, followed by a description of the small amount of research using ai in treatment. a review of studies of internet-delivered cbt (icbt) to youth, using waitlist controls, supports the conclusion that cbt could be successfully adapted for internet-based treatment (vigerlan et al. ) . in a meta-analytic review of meta-analyses, containing studies of adult use of internet delivered via icbt, the authors concluded that icbt is as effective as face-to-face therapy (andersson et al. ) . hermes et al. ( ) include websites, software, mobile aps, and sensors as instances of what they call behavioral intervention technologies (bit). in their informative article, dealing primarily with implementation, they note that these technologies (they do not mention ai) can relate to a clinician in three ways: ( ) when intervention is delivered by the clinician and supported by bit, ( ) when bit provides the intervention with support from the clinician, or ( ) when intervention is fully automated with no role for the clinician. this schema clearly applies to the ai interventions and the role of clinicians as well. their conceptual model is helpful in understanding the parameters of implementation. they present a comprehensive plan for research to fill in the major gaps in the literature that addresses the question of comparative effectiveness of bit and traditional treatment. carlbring et al. ( ) conducted a systematic review and meta-analysis of eligible studies of ibct versus face-to-face cbt and reported that they produced equivalent outcomes, supporting the conclusions drawn by previous studies. it is also important to consider the issue of therapeutic alliance (ta) and its relationship to internet-based treatment. ta, to a large extent, is designed to capture the human aspect of the relationship between the clinician and the client. there are thousands of correlational studies that have established that ta is a predictor of treatment outcomes (flückiger et al. ) ; however, there are few studies of interventions that show a causal connection between ta and outcomes (e.g., hartley et al. ) . moreover, the very nature of ta as trait-like or state-like, which is central to causal assumptions, is being questioned and is subject to new research approaches (zilcha-mano ) as well as to questions about how it should be measured regardless of my doubts about the importance of ta, the fluckiger et al. ( ) meta-analysis found similar effect sizes (r = . ) for the alliance-outcome relationship in online interventions and in traditional face-to-face therapies. however, most of these studies were guided by a therapist, so the human factor was not totally absent. penedo et al. ( ) , in their study of a guided internet-based treatment, showed that it was important to align with the client's expectations and goals because these were related to outcomes, but no such relationship existed with the traditional third component of ta, bond with the supporting therapist, implying that ta might play a different role in internetbased treatments. i was trained as a social psychologist and was a graduate student of stanley milgram (of the famous obedience experiments), so i was curious about the research on the relationship between technological virtual agents and humans beyond the context of mental health treatment. several studies cited by schneeberger et al. ( ) showed that robots could get people to do tiring, shameful, or deviant tasks. the authors found that participants obeyed these virtual agents similarly to the way they responded to humans in a video-chat format. the participants did the same number of shameful tasks regardless of who or what was ordering them. moreover, doing the tasks produced the same level of shame and stress in the participant. they concluded that virtual agents and humans appear to have the same influence as human experimenters on participants. of course, there are many limitations associated with generalizing from this laboratory study, which was conducted with female college students in germany, but it does suggest that a great deal of research needs to be done on how humans relate to robots and virtual agents. miner et al. ( ) suggest that use of conversational ai in psychotherapy can be an asset for improving access to care, but there is limited research on efficacy and safety. can we learn about the role of the therapist from therapies that do not involve any therapist or technology? there is substantial research on self-help approaches from written material or what some call bibliotherapy. in general, research has supported the effectiveness of bibliotherapy before the advent of digital approaches. in , cuijpers et al. published a review of the literature that compared face-to face psychotherapy for depression and anxiety with guided selfhelp (i.e., with some therapist involvement) and concluded that they appeared comparable, but because there were so few studies in this comparison, this conclusion should be interpreted with caution. has the situation changed in the last decade? in a comprehensive review and meta-analysis almost years later, bennett et al. ( ) conducted a review and meta-analysis of studies. they concluded that self-help (both guided and unguided) had significant moderate to large effects on reducing symptoms of anxiety, depression, and disruptive behavior. however, there was also very high heterogeneity among the outcomes of these studies. compared to face-to-face therapy, self-help was better than no treatment but slightly worse than face-to-face treatments, guided therapy was better than unguided, and computerized treatment was better than bibliographic treatment. it is important to note that none of the studies were fully powered noninferiority trials, which would be a superior design. the authors concluded that their study showed potential near equivalence for self-help compared to faceto-face interventions, and their conclusions were consistent with several other reviews of self-help for mental health disorders in adults. the paper makes no mention of ai. cuijpers et al. ( ) conducted a network meta-analysis of trials of cbt addressing the question of whether format of delivery (individual, group, telephone-administered, guided self-help, or unguided self-help) influenced acceptability and effectiveness for these adult patients with acute depression. no statistically significant differences in effectiveness were found among these formats except that unguided self-help therapy was not more effective than care as usual but was more effective than a waitlist control group. the authors concluded that treatments using these different formats should be considered alternatives to therapist-delivered individual cbt. as in the previous publication, there was no mention of the use of ai, but cuijpers believes that few if any of the studies reviewed in his publication used ai (p. cuijpers, personal communication, march , ) . there is an emerging area of the use of ai in treatment that is informative. tuerk et al. ( ) , in a special section of current psychiatry reports focusing on psychiatry in a digital age, describe several approaches to using technology in evidence-based treatments. most relevant is their discussion of the use of ai in what has been called "conversational artificial intelligence" where there is a real-time interchange between a computer and a person. they note research that shows that this approach is low risk, high in consumer satisfaction, and high in self-disclosure. they suggest that there is a great deal of clinical potential in using ai in this manner. in a review of the literature from to on conversational agents used in the treatment of mental health problems, gaffney et al. ( ) found only qualifying studies out of an initial , with four being what they called full-scale rcts. they concluded that the use of conversational agents was limited but growing. all studies showed reduced psychological distress, with the five controlled studies showing a significant reduction compared to control groups. however, the three studies that used active controls did not show significant differences between the waitlist controls and use of a conversational agent, although all showed improvement. the authors concluded that the use of conversational agents in therapy looks promising, but not surprisingly, more research is needed. a similar conclusion on conversational agents was reached in another independent review (vaidyam et al. ) . i have little doubt that more research will be forthcoming in this emerging area. in summary, previous research using digital but not aipowered icbt, self-help (bibliotherapy), and ai-powered conversational agents suggests that effective treatment can be delivered without a human clinician under certain circumstances. i want to emphasize that these studies are suggestive but far from definitive. rather, they suggest that the role of the clinician is worth more exploration, but they do not establish the conclusion that we do not need clinicians to deliver services. we need to know a great deal more about how ai-supported therapy operates in different contexts. a survey of psychiatrists from countries asked about how technology will affect their future practice (doraiswamy et al. ) . only . % felt their jobs would become obsolete, and only a small minority ( %) felt that ai was likely to replace a human clinician in providing care. as much of the literature on the effects of ai on jobs suggests, those surveyed believed that ai would help in more routine tasks such as record keeping ( %) and synthesizing information, with about % believing their practices would be substantially changed. about % thought ai would have no influence or only minimal effect on their future work over the next years. another % thought their practices would be moderately changed by ai over the next years. more than three quarters ( %) thought it unlikely that technology would ever be able to provide care as well as or better than the average psychiatrist. only % of u.s.-based psychiatrists predicted that the potential benefits of future technologies or ai would outweigh the possible risks. some of the specific tasks that psychiatrists typically perform, including mental status examination, evaluation of dangerous behavior, and the development of a personalized treatment plan, were also felt to be tasks that a future technology would be unlikely to perform as well. i do not think many psychiatrists in this study are prepared for the major changes in their practices that are highly likely to occur in the next quarter century. in a thoughtful essay on the future of digital psychiatry, hariman et al. ( ) draw a number of conclusions. they predict major changes in practice, with treatment by an individual psychiatrist alone becoming rare. patients will receive treatment through their phones, participate in videoconferencing, and converse with chatbots. clinicians will receive daily updates on the patients through remote sensing devices and self-report. ai will be involved in both diagnosis and treatment and will integrate diverse sources of information. concerns over privacy and data security will increase. this is not the picture that the previously described survey of psychiatrists anticipated. brown et al. ( ) present the pros and cons of ai in an interesting debate format. on the pro side, the authors argue that while there are current limitations, the improvements in natural language processing (nlp) will lead to better clinical interviews. they point to research that shows people are more likely be honest with computers as a plus in obtaining more valid information from clients. they expect the ai "clinician" will be seen as competent and caring. they do note the danger that non-transparent ai will produce unintended negative side effects. those arguing against the use of ai clinicians acknowledge the technical superiority of ai to accomplish more routine tasks such as information gathering and tracking, but they point out the limitations even in the development of ai therapists. the lack of data needed to develop and test algorithms is critical. i have noted this in the discussion of the diagnostic muddle as a problem that ai can help solve, but these anti-ai authors argue that because psychiatrists disagree on diagnoses, there is no gold standard against which to measure the validity of ai models. this seems to be a rather unusual perspective from which to challenge change. they insightfully note that ai is different from human intelligence and does not perform well when presented with data that are different from training data. but the anti-ai authors acknowledge that more and better data may lead to improvement. brown et al. ( ) argue that common sense is something that ai cannot draw on; however, this seems to be a weak argument when common sense has been demonstrated to be inaccurate under many situations. they conclude with the statement that psychiatry "will always be about connecting with another human to help that individual" (p. ). this may be more wishful thinking than an accurate prediction about the future. those arguing the pro position state that the "the advance of ai psychiatry is inexorable" (p. ). on the other hand, the opponents of ai correctly point out that there is not yet sufficient evidence to draw a conclusion about the effectiveness of ai versus human clinicians. while there is disagreement about the potential advantages and disadvantages of ai, both sides agree that we need more and better research in this area. simon and yarborough ( ) present the case that ai should not be a major concern for mental health. they argue that ideally, our field would abandon the term artificial intelligence in regard to actual diagnosis and treatment of mental health conditions. using that term raises false hopes that machines will explain the mysteries of mental health and mental illness. it also raises false fears that all-knowing machines will displace human-centered mental health care. big data and advanced statistical methods have and will continue to yield useful tools for mental health care. but calling those tools artificially intelligent is neither necessary nor helpful. (p. ) the authors further take the position that despite the buildup around artificial intelligence, we need not fear the imminent arrival of "the singularity," that science fiction scenario of artificially intelligent computers linking together and ruling over all humanity. . . a scenario of autonomous machines selecting and delivering mental health treatments without human supervision or intervention remains in the realm of science fiction. (p. ) a more balanced approach to the role to the issue of replacement of clinicians by ai is presented by ahuja ( ) . after his review of the literature on medical specialists who may be replaced or more likely augmented by ai, his pithy take on this question is "or, it might come to pass that physicians who use ai might replace physicians who are unable to do so" (ahuja , p. ) . clearly, ai research will have to provide strong evidence of its effectiveness before ai will be accepted by some in the psychiatric community. there are several pressing questions about how mental health services should be delivered and about the future of mental health services. doubts about how much clinicians contribute to outcomes, our seeming inability to differentiate the effectiveness among clinicians except at the extremes, the lack of stability of employment of most community based clinicians, the poor track record on implementation of evidence-based programs, the cost of human services, the very limited availability of services especially where resources are inadequate-all lead to strong doubts about continuing the status quo of using clinicians as the primary way in which mental health services are delivered. in contrast, alternative approaches have many advantages. if scaled, ai therapists could be available to patients / and would not be bound to office hours. these ai therapists could represent any demographic or therapy style (e.g., directive) that the client preferred or that had been found to be more effective with a particular client. they can be specialists in any area for which there is sufficient research. in other words, not only can a personalized treatment plan be developed, but a personalized clinician (avatar) can be constructed for the best match with the client. of course, all these are putative advantages. as noted earlier, the application of ai is not without its risks and challenges, especially in putting together the interdisciplinary teams needed to accomplish this research. while i am optimistic about the potential contribution of ai to mental health services, it is just that-a potential. extensive research will be needed to learn whether these approaches produce positive outcomes when compared to traditional face-to face treatment, while also dealing with the ethical issues raised by ai applications. moreover, the quality of research needs significant improvement if we are going to have confidence in the findings. however, as exemplified by the rapid and uncontrolled growth of therapy apps, the world may not wait for rigorous supporting research before adopting a larger role for ai in mental health services. while my brief summaries of findings of ai in the medical literature are supportive of the application of ai, i do not want to give the impression that these positive findings are accepted uncritically. a deeper reading of many of these studies exposes methodological flaws that temper enthusiasm. for example, in reviewing comparisons between healthcare professionals and deep learning algorithms in classifying diseases of all types using medical imaging, x. liu et al. ( a) conclude that the ai models are equivalent to the accuracy of healthcare professionals. this review is the first to compare the diagnostic accuracy of deep learning models to health-care professionals; however, only a small number of the studies were direct comparisons. the authors also caution us by indicating what they labeled as the poor quality of many of the studies. the problems included low external validity (not done in a clinical practice setting), insufficient clarity in the reporting of results, lack of external validation, and lack of uniformity of metrics of diagnostic performance and deep learning terminology. however, the authors were encouraged by improvement in quality in the most recent studies analyzed. in commenting on the study, cook ( ) noted other limitations and concluded that it is premature to draw conclusions about the comparative accuracy of ai versus human physicians. if we are not more cautious, she warns that we will experience "inflated expectations on the gartner hype cycle" (p. e ). the latter refers to the examination of innovations and trends in ai. she cautions us to "stick to the facts, rather than risking a drop into the trough of disillusionment and a third major ai winter" (p. e ). many issues are raised in cook's paper, and the need to avoid the hype often found in the ai field is reiterated in the national academy of medicine's monograph on the use of ai in healthcare (matheny et al. ) . mental health services are changing. there are more than , mental health apps on the internet that are being used without much evidence of their effectiveness (marshall et al. ; bergin and davis ; gould et al. ) . the explosion of mental health apps is the leading edge of future autonomous interventions. however, there is pressure to bring some order to this chaos. probably the next innovation that will involve ai is its use in stepped therapy in which clients are typically triaged to low-intensity, low-cost care, monitored systematically, and stepped up to more intensive care if progress is not satisfactory . in this schema, the low-cost care could be ai-based apps with little risk to the client. if more confidence is gained in the safety and effectiveness of this type of protocol, the use of ai-based treatment would be expected to increase. the covid- pandemic will produce a major impact on mental health services. first, it is expected that the stresses caused by the pandemic will increase the demand for services (qiu et al. ; rajkumar ) . already poorly resourced mental health systems will not be able to meet this demand (Ćosić et al. ; ho et al. ; holmes et al. ) , especially in low resourced countries. however, the biggest change will be in the service delivery infrastructure. because of social distancing requirements, in-person delivery of therapy is being severely curtailed. while the major change at this time appears to be a shift to telemedicine (shore et al. ; van daele et al. ) , which is being adopted across almost all healthcare, there will need to be changes instituted in how clinicians are trained and supervised (zhou et al. ) . i have little doubt that ai will be adopted in order to increase efficiency and address the change in the service environment caused by the pandemic. in addition to changes initiated by the pandemic, there appear to be some changes in funding as a result of the protests concerning george floyd's killing. there is reconsideration of shifting some funding from police services to mental health and conflict reduction services to be delivered by personnel outside law enforcement (stockman and eligon ) . it will be difficult to meet this potential demand using the current infrastructure. the literature on ai and medicine is replete with warnings about the difficulties we face in integrating ai into our healthcare system. as a program evaluator, i appreciate the position paper describing the urgent need for well-designed and competently conducted evaluations of ai interventions as well as the guidelines provided by magrabi et al. ( ) . more suggestions for improving the quality of research on supervised machine learning can be found in the paper by cearns et al. ( ) . celi et al. ( ) describe the future in a very brief essay that is worth quoting: clinical practice should evolve as a hybrid enterprise with clinicians who know what to expect from, and how to work with, what is fundamentally a very sophisticated clinical support tool. working together, humans and machines can address many of the decisional fragilities intrinsic to current practice. the human-driven scientific method can be powerfully augmented by computational methods sifting through the necessarily large amounts of longitudinal patientand provider-generated data. (p. e ) however, research on ai, data science, and other technologies is in its infancy if not the embryonic stage of development. i am fully immersed in the struggle to implement several types of technologies in practice. changing the routine behavior of clinicians and clients is a major barrier to using new technologies, regardless of the effectiveness of these approaches. emanuel and wachter ( ) argue that the most important problem facing healthcare is not the absence of data or analytic approaches but turning predictions and findings into successful accomplishments through behavior change. alongside the investment in technology and analytics, we need to support the research and applications of psychologists, behavioral economists, and those working in the relatively new field of translational and implementation research. the emphasis on practical and implementable digital approaches requires a methodology that departs from the traditional efficacy approach, which does not focus on context and thus is difficult to translate to the real world. mohr et al. ( ) suggest a solution-based approach that focuses on three stages that they label create, trial and sustain. creation focuses on the initial stages of development, although not exclusively, and takes advantage of the unique characteristics of digital approaches that focus on engagement rather than trying to mimic traditional psychotherapy. trial must be dynamic because digital technologies rapidly change; rapid evaluations are required, such as continuous quality improvement strategies (bickman and noser ) . sustainability requires more from investigators and evaluators than publication of results; they must also produce sustainable implementation that no longer depends on a research project for support. we are currently in an ai summer in which there are important scientific breakthroughs and large investments in the application of ai (hagendorff and wezel ) . but ai has had several winters when enthusiasm for ai has waned and unreasonable expectations have cooled. we were confronted with the reality that ai could not accomplish everything that people thought it could and that investors and journalists had hyped. ai, at least in the near term, will not be the superintelligence that will destroy humanity or the ultimate solution that will solve all problems. enthusiasm for ai seems to run in cycles like the seasons. ai summers suffer from unrealistic expectations, but the winters bring an experience of disproportionate backlash and exaggerated disappointment. there was a severe winter in the late s, and another in the s and s (floridi ) . today, some are talking about another predictable winter (nield ; walch ; schuchmann ). floridi ( ) suggests that we can learn important principles from these cycles. first is whether ai is going to replace previous activities as the car did with the buggy, diversify activities as the car did with the bicycle, or complement and expand them as the plane did with the car. floridi asks how acceptable an ai that survives another winter will be. he suggests that we need to avoid oversimplification and think deeply about with we are doing with ai. in the june issue of the technology quarterly of the economist ( ), it is suggested that because ai's current summer is "warmer and brighter" than past ones because of widespread deployment of ai, "another fullblown winter is unlikely. but an autumnal breeze is picking up" (p. ). i have traced a path my career has taken from an almost exclusive focus on randomized experiments to consideration of the applications of ai. i have identified the main problems related to mental health services research's almost sole dependence on rct methodology. i have linked the problems with this methodology with the lack of satisfactory progress in developing sufficiently effective mental health services. the recent availability of ai and the value now being placed on precision medicine have produced the early stages of a revolution in healthcare that will determine how treatment will be developed and delivered. i anticipate that in the very near future, a first-year graduate student will be contemplating the same questions that i raised years ago, because they are still relevant, but this time he or she will realize that there are answers that were not available to me. acknowledgements this paper is part of a special issue of this journal titled "festschrift for leonard bickman: the future of children's mental health services." the issue includes a collection of original children's mental health services research articles, this article, three invited commentaries on this article, and a compilation of letters in which colleagues reflect on my career and on their experiences with me. the word festschrift is german and means a festival or celebration of the work of an author. there are many people to thank for their assistance in both the festschrift and this paper. first, i want to acknowledge my two colleagues and friends, nick ialongo and michael lindsey, who spontaneously originated the idea of a festschrift during a phone conversation with them. the folks at the johns hopkins bloomberg school of public health were great in supporting the daylong event held on may , . the many friends, family, former students and colleagues who traveled from around the country to attend and present made the event memorable. i am grateful to the committee that helped put this special issue together, which included marc atkins, catherine bradshaw, susan douglas, nick ialongo, kim hoagwood, and sonja schoenwald. this paper represents more than a yearlong effort for which many contributed including the scholars who provided email exchanges and ideas throughout the conceptualization and writing process. i thank the two editors of this special issue, sonja and catherine, who spent much of their valuable time on this project during a very difficult period. the manuscript was greatly improved through the efforts of my copy editor, diana axelsen. most of all i thank corinne bickman, who has been my partner in life for almost years and has managed this journal since its inception. without her support and love none of this would have been possible. funding no external funding was used in the preparation or writing of this article. conflict of interest from the editors: leonard bickman is editorin-chief of this journal and thus could have a conflict of interest in how this manuscript was managed. however, the guest editors of this special issue, entitled "festschrift for leonard bickman: the future of children's mental health services," managed the review process. three independent reviews of the manuscript were obtained and all recommended publication with some minor revisions, with which the editors concurred. while the reviewers were masked to the author, because of the nature of the manuscript is was not possible to mask the author for the reviewers. from the author: the author reported receipt of compensation related to the peabody 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alliance really therapeutic? revisiting this question in light of recent methodological advances major developments in methods addressing for whom psychotherapy may work and why key: cord- -ml qjipn authors: kopelovich, sarah l.; monroe-devita, maria; buck, benjamin e.; brenner, carolyn; moser, lorna; jarskog, l. fredrik; harker, steve; chwastiak, lydia a. title: community mental health care delivery during the covid- pandemic: practical strategies for improving care for people with serious mental illness date: - - journal: community ment health j doi: . /s - - -z sha: doc_id: cord_uid: ml qjipn the covid- pandemic has presented a formidable challenge to care continuity for community mental health clients with serious mental illness and for providers who have had to quickly pivot the modes of delivering critical services. despite these challenges, many of the changes implemented during the pandemic can and should be maintained. these include offering a spectrum of options for remote and in-person care, greater integration of behavioral and physical healthcare, prevention of viral exposure, increased collaborative decision-making related to long-acting injectable and clozapine use, modifying safety plans and psychiatric advance directives to include new technologies and broader support systems, leveraging natural supports, and integration of digital health interventions. this paper represents the authors’ collaborative attempt to both reflect the changes to clinical practice we have observed in cmhcs across the us during this pandemic and to suggest how these changes can align with best practices identified in the empirical literature. the current coronavirus disease (covid- ) pandemic has required dramatic transformation of the delivery of outpatient mental health services for individuals with serious mental illness (smi) in the us. federal and state guidelines limit face-to-face contact and specifically request that health facilities limit in-person contact. this transformation in care delivery has tremendous public health implications, as individuals who receive care through the public mental health system are particularly vulnerable during public health crises (druss ) . multiple factors contribute to increased risk of infection and poorer outcomes in this population, including disparities in access to healthcare, and increased risk of contracting covid- due to social inequalities (e.g., increased rates of poverty leading to residential instability and food security, high unemployment rates), higher rates of medical conditions, and unhealthy behaviors (e.g., chowkwanyun and reed ) . moreover, the risk of poorer mental health outcomes is further exacerbated by the pandemic, and this must also be recognized as a public health priority (williams and cooper ) . since there is currently no vaccine or specific treatment for covid- , current health efforts focus on providing prevention and screening, ensuring access to appropriately intensive services for those with the most severe symptoms, and maintaining continuity of treatment for other chronic conditions (adalja et al. ) . the pandemic presents a serious threat to the continuity of treatment for smi. it is critical for community mental health centers (cmhcs) to develop plans to ensure that they can maintain essential services and adequate supplies of psychotropic medications. this paper aims to provide community mental health providers who are working with clients with smi with practical recommendations for optimizing the continuity of care in the context of rapidly evolving mandates and recommendations for healthcare providers. clients with smi who are served by cmhc outpatient and outreach teams may have chronically elevated risk of severe functional impairments, emergency department visits, psychiatric hospitalizations, harm behaviors, arrest and incarceration, food and water insecurity, and homelessness. during a public health crisis, these risk factors must be considered along with the individual's risk of covid- infection to determine how to best meet an individual's treatment needs. medical and psychiatric risks and benefits for every individual client should be weighed by the clinical team, with input from the medical director as needed, to decide if there is an urgent or essential need that necessitates inperson care and, if so, what modifications to care delivery are necessary. in addition, natural supports, warm lines, and pandemic-compatible psychiatric advance directives should become the standard of care in the peri-and post-covid era. clinics should consider a spectrum of service delivery options that are responsive to clients' needs and preferences for care as well as their psychiatric and medical risk status (see fig. ). these care delivery options are not mutually exclusive. indeed, using a variety of care delivery methods in combination may support frequent contact without increasing the risk of client or staff exposure to the virus. the spectrum includes in-person care in the community with appropriate preventative measures; clinic-based care in a larger room that allows physical distancing; clinic-based telehealth, in which the client is accommodated in a private clinic office for a telepsychiatry session with their provider; clinic-based care in a standard office in a manner consistent with local public health guidelines; and telehealth encounters with clients at home or in the community. clinic-delivered care can also be extended by coaching family members, establishing linkages to warm lines, and supplemental forms of e-mental health (for a review of e-mental health literature, see lal and adair ) . each of these options are reviewed below, followed by delineation of key considerations for care delivered in-person and by telehealth. while most cmhcs may be able to shift to telehealth practices for many clients, a significant group of clients will continue to need in-person services to help meet basic needs or because they lack access to the required technology or data plans required to engage in telehealth. but telehealth can be adapted to address technologic or psychosocial barriers. for instance, the client can present to clinic for a telehealth session in a private office, thereby minimizing close contact with clinic staff. clients who present with cognitive disorganization or paranoia related to technology or surveillance may be amenable to telephone encounters, which represent an efficient, familiar alternative for clients, and hold greater pragmatic appeal to cmhcs in states that can now receive equitable compensation for certain types of telephone encounters (e.g., washington state emergency order no. - , ) . telephone encounters have limitations that impact clinical care, though, as they may limit clinical observation, therapeutic engagement, assessment, and interventions, further reinforcing the need to diversify therapeutic contacts. in the short term during the pandemic, providers may need to temporarily shift from skills teaching and other rehabilitation efforts to direct assistance with basic needs. to this end, providers may need to coordinate with the client, natural supports, representative payees, faith communities, and social service organizations to locate resources, prepare care packages, and even prepare and drop off warm meals. providers doing outreach visits should avoid entering homes, especially if it is a closed space or when others are in the residence and control over physical distancing is less certain. outreach teams should meet outside the residence in well-ventilated areas, to visually assess how the person is doing, present as a familiar and comforting supportive social visit, model and reinforce behaviors, deliver medications, and provide an in-person demonstration of how to use smartphones or other devices to engage in e-mental health. with all in-person encounters, providers need to be familiar with and adhere to local public health infection control guidelines on personal protective equipment (ppe) and physical distancing. in addition to a multimodal plan service delivery, care should also leverage all available members of the clinic staff, natural supports, and ancillary services, in an "all hands on deck" fashion. administrative staff such as receptionists can make welfare phone calls to check on clients, or may be able to provide learning sessions to clients to prepare them for telehealth sessions. peer specialists can continue to play a key role in supporting person-centered wellness management and coping skills, coaching and consultation to promote self-efficacy and self-advocacy, and problemsolving client needs. peer specialists and case managers may be helpful in facilitating access to virtual spiritual, peerbased, recreational, and other communities to help clients connect with others. therapists may replace or augment full clinical sessions in the short-term with telephone sessions intended to coach the client in the acquisition, strengthening, and rehearsal of specific behavioral skills in order to avert a behavioral crisis. families and caregivers may be in a position to support their loved one experiencing a mental illness, and are available more hours in a given day or week than the treatment team, especially if living with their loved one. now, more than ever, providers need to enlist families as partners in care delivery. providers can augment services by directing some of their efforts to natural supports, such as, skills they teach directly to individual clients. as a team, providers can work with both clients and families to plan for structuring their day, especially with leisure activities and opportunities for social connectedness while physical distancing. while this places demands on families, it may prove to be an important avenue for supplementing shorter clinical sessions, particularly with clients who are not engaging in video or phone sessions. families can be further supported with cloud-based shared folders or other resources that contain educational and training materials (e.g., manuals, clinical tips sheets for family members) to supplement direct care. additionally, many community mental health systems offer support from trained family specialists who have lived experiences with a loved one with mental illness who may be available to families during this time. for those who are not connected to family or other natural supports, providers will need to help identify and extend other natural supports available to the client. as long as physical distancing is necessary, virtual connections and online communities are even more key. unlike hotlines or crisis lines, which are designed to be responsive to individuals in the throes of a psychiatric emergency, warm lines are designed to be a comforting option for people experiencing distress and seeking emotional support. the covid- pandemic has led to the expansion of the availability of warm lines, many hosted by peer support organizations. a national crisis text service, crisis text line, provides free confidential text message service for people in crisis (users can text home to to be connected to a crisis counselor). some states have developed their own emotional support text lines, such as call calm, a free-of-charge texting service made available by the illinois department of human services' mental health division to english and spanish-speaking residents (halstead ) . providers may wish to curate these resources, help input phone numbers into clients' cell phones, and post them to agency websites or social media. providers should work with clients to update safety plans, and help clients to establish or update a psychiatric advance directive that includes contingency planning related to pandemics. advance directives delineate an individual's wishes in the event that they are unable to express their wishes for health care and treatments. under federal law, facilities receiving cms reimbursements are required to use advance directives, including for behavioral health conditions. the american psychiatric association's smi adviser program (www.smiad viser .org) has released a digital version of a psychiatric advance directive, called my mental health crisis plan (smi advisor ) that meets the legal requirement for all states and allows for tailoring to where the individual resides. companion guidance documents to facilitate collaboration with both natural supports and providers to develop and execute the psychiatric advance directive are in development. as hospitals and crisis centers may be differentially impacted by the covid- pandemic, individuals should factor in treatment setting to their advance directives. it is important to inform the client that it may not be possible to accommodate some aspects of their advance directive, given that circumstances and resources are quite fluid during this time. providers should help to problem-solve around these contingencies in order to best ensure maximal application of the individual's wishes within their psychiatric advance directive. the virtues of virtual care have been well-documented, as has its underutilization in public behavioral health (schmeida et al. ; simmons et al. ) . institutional and policy barriers to broad dissemination of telepsychiatry and digital health interventions (saeed et al. ) are now being surmounted in response to emergent need. federal policy shifts have also signaled widespread recognition that the flexible use of digital health technologies may be required to maintain uninterrupted mental health services during the covid- crisis. for instance, the office for civil rights (ocr) has announced that it would waive penalties embedded in the health insurance portability and accountability act (hipaa) against health care providers who serve their clients using "everyday communications technologies," (department of health and human services ) although we are sensitive to the dialectic between reducing barriers to care and protecting patient rights (hall and mcgraw ) . evidence suggests that the use of telepsychiatry (both via telephone and videoconferencing) is both feasible and acceptable for individuals with smi, and may improve client outcomes (baker et al. ; kasckow et al. ) . that said, research on telepsychiatry practice has typically involved rigorous implementation planning, support, and evaluation. in contrast, the urgent need to provide telehealth services quickly has resulted in clinical sites across the us scrambling to adopt new technology, workflows, job aids, and training for their providers who are simultaneously addressing emergent clinical needs. clients may not have access to the hardware, software, or data plans required for telepsychiatry. both staff and service users may require several learning sessions to become proficient enough for independent use. key targets for assessment and management using telehealth modalities are discussed in the next section. telepsychiatry practice guidelines are beyond the scope of this article, but can be accessed online (https ://www.psych iatry .org/psych iatri sts/pract ice/telep sychi atry/toolk it/pract ice-guide lines ). mental health providers will need to make the most of potentially limited time for assessment and treatment, as clients with psychosis may not be able to tolerate long sessions via phone or video call. providers should aim to increase the frequency (and perhaps reduce the duration) of their client encounters (e.g., transition from one weekly -min session to twice weekly -min sessions). more frequent visits may provide greater opportunities for assessment of dynamic factors associated with increased risk of functional impairment, victimization, substance use, self-harm, violence, and change in housing or employment status. in addition, increased contact with members of the clinical team also provides more social contact during this period of physical distancing. communication and building trust over the phone are particularly challenging with clients with significant thought disorganization and paranoia, and providers will need to skillfully interweave engagement, assessment, and intervention strategies. providers may find it particularly difficult to assess and engage clients who are newly enrolled in services effectively via telehealth. a complete initial assessment and building a therapeutic relationship can be difficult over the phone. new clients may benefit most from at least an initial in-person visit to allow a more thorough intake assessment and diagnostic interview including physical observation and exam, as indicated. telemedicine using videoconferencing is the second-best option for new clients, with telephone encounters being used as a stop gap. notably, telehealth offers opportunities for environmental and interpersonal assessments that are not afforded during clinic visits, and these data may help to advance clients' functional recoveries. several targets for assessment and treatment should be prioritized for both new and existing clients, including safety assessment and management, psychological and pharmacotherapeutic strategies to manage psychiatric symptoms and co-occurring substance use disorders, assessment and management of physical health, and augmenting care by enlisting natural supports and employing asynchronous digital health interventions. comprehensive and effective community-based mental health treatment is essential to limit emergency room visits and inpatient psychiatric hospitalizations that increase risk of covid- exposure and further overload the health care system. along with clinic administrators, the medical director, and/or the risk management team, providers should weigh the risks and benefits of seeing a client who is at elevated risk of potentially lethal self-injurious behavior or violence toward others in-person versus via telehealth. clients who are less familiar to the clinical team, for whom historical and clinical risk factors are particularly high, or who are newly expressing behavioral intent to harm self or others should be prioritized for in-person care with appropriate measures to reduce risk of infection (ppe, physical distancing, etc.). as hospital beds may be even more difficult to access and some traditional clinic-based services will be reduced, administrators may need to re-deploy some outpatient clinical staff to outreach and crisis response teams to enhance capacity for both proactive and reactive contact with clients in-need, with appropriate precautions for both clients and staff. at the start of all telehealth and telephonic encounters, it is critical for the provider to obtain and document the client's phone number and current location. the phone number is important for technological troubleshooting, (client cannot access videoconference, or gets disconnected). an exact address from which they are calling is important to provide enough detail to direct emergency services to the client's location if necessary for a welfare check. it is imperative that safety plans are created and updated to ensure that all aspects of the plans are compatible with the restrictions in place in clients' immediate environments. if the client already has a safety plan, efforts should be made to ensure that the client has easy access to the plan in multiple modalities and that all aspects of the plan are feasible. depending on the nature of suicidal or homicidal ideation, distress tolerance will be most helpful to engage the client in down-regulation until the acute crisis remits. the my app (www.my ap p.org) adapts an evidence-based strategy for safety planning to a print or mobile application (stanley and brown ) . it is critically important for providers to identify triggers to suicidal urges; teach the client to look for affective, cognitive, or physiologic cues; and help the client to plan new responses when early warning signs emerge. ideally, natural supports-particularly those who live with the client-will contribute to identifying early warning signs and assist with adherence to the safety plan, if the client agrees to their participation. excessive worry, anxious avoidance, and insomnia are prevalent to high degrees in individuals suffering from mood and psychotic symptoms, represent putative causal factors for psychosis, and are each treatable intervention targets (freeman et al. ). in addition, poor self-regard-consisting of negative self-beliefs and low self-efficacy-are known correlates of both depression and psychosis (freeman ; sowislo and orth ). these important targets of in-person cognitive behavioral treatments of mood and psychotic disorders can also be addressed via remote care. during times of stress and uncertainty, clients may lapse into former, maladaptive habits. as providers and clients become more proficient in the use of telehealth, their intervention strategies more closely approximate in-person care (e.g., resuming prolonged exposure for ptsd; morland et al. ). in the interim, the priority during the public health crisis is to manage lapses in an effort to prevent relapse, acute decompensation, and risk behaviors. providers who are new to clients should rely heavily on befriending and engagement strategies before attempting to systematically intervene. even among existing clients, befriending and engagement strategies should be the fallback if the client becomes more reluctant to discuss delusions and hallucinations (kingdon and turkington ) after transitioning to telehealth. while symptom management strategies should be tailored to individuals' needs, preferences, and their ability to learn and practice new skills using e-mental health, all clients are likely to benefit from efforts to broaden their repertoire of distress tolerance skills for distressing beliefs and hallucinations, anxiety management strategies such as paced breathing, and behavioral activation, each of which are amenable to delivery in brief sessions (wright et al. ) to help manage distressing emotions. skills practice can be enhanced through virtual communities, websites, and-as detailed below-mobile health applications. as a transdiagnostic and translational model, cbt interventions for a variety of presenting problems can be delivered through telepsychiatry (mclay et al. ) . cbt and dbt skills training can help clients sustain gains and experience relief from emergent symptoms (matsumoto et al. ; stubbings et al. ) . telehealth may also be beneficial in understanding and addressing environmental contributors to symptoms, reducing no shows, and even improving engagement. although less studied, psychotherapy groups can also be offered through teletherapy (backhaus et al. ) , and some resources are available to support practitioners as they transition groups to videoconference (e.g., https :// mhttc netwo rk.org/). special attention should be given to individuals with substance use disorders, whether or not they were actively using substances prior to the pandemic. individuals with a history of substance use are at elevated risk of relapse, and urges to use should be normalized, monitored, and addressed with appropriate environmental, motivational, behavioral, cognitive, and-if applicable-pharmacologic interventions. individuals who are currently engaging in substance use may be particularly vulnerable to complications from covid- due to disproportionate rates of homelessness and incarceration compared to those without substance use, drug seeking behaviors that put them in close contact with others, and also effects of certain drugs on the lungs and respiratory system. in addition, practitioners must be mindful of the elevated risk of withdrawal syndromes related to sudden disruptions in the drug supply chain or inability to access medication-assisted treatment (mat). symptoms of withdrawal syndromes vary based on the substance, but can include increased anxiety and agitation, tremors, nausea, difficulty sleeping, increased psychotic and mood symptoms, and increased suicidal ideation. the provider should alert the client to these effects of discontinuation and promote harm reduction practices to balance safe discontinuation and consumption of substances. harm reduction approaches for clients with co-occurring substance use and psychiatric disorders during the covid- crisis should include maintaining frequent contacts across remote modalities (videocalls, phone, and texting, as available), generous use of befriending and normalization strategies, education on safer options for drug administration and drug administration sites, as well as a review of available mat options. in addition, providers can help clients develop strategies to promote safer social interactions that are acceptable to the client. emotion regulation strategies and distress tolerance skills that focus on activating the parasympathetic nervous system should be the main focus for these clients. among clients with cognitive impairment and/or disorganization, preference is given to depth over breadth to enhance overlearning. providers should coach the client to independently administer one or two skills that are effective in reducing subjective units of anxiety ( - %), rather than teaching a variety of these skills. clients should also identify a natural support they can access for skills coaching if a member of the cmhc's clinical team is not available for phone coaching, and that individual should be conferenced into remote clinical encounters whenever possible. community mental health providers are often the primary point of contact with the health care system for their clients with smi and represent the first responders to the covid- pandemic for many of these individuals. medical management during this time should target prevention strategies for covid- infection, management of physical health conditions in partnership with primary care and public health, support of smoking reduction or cessation, medication management, and lab monitoring. mental health providers need to be able to recognize the signs and symptoms of covid- illness, educate clients about basic strategies to recognize symptoms, and translate public health recommendations in ways that are comprehensible and implementable by clients. client-facing materials developed for general populations may need to be tailored to address limited health literacy (farrell et al. ) and promote more harm reduction strategies to mitigate viral exposure. providers can help clients problemsolve logistical barriers to reducing risks of infection, in some cases choosing among several options that are all associated with some risk. many social services and settings on which clients rely (e.g., clubhouses, food pantries, shelters) may be temporarily unavailable or present an unacceptable level of risk of infection. treatment plans that include clinic or pharmacy visits should specifically include strategies to reduce risk of covid- infection. risk mitigation strategies may be more challenging for some clients to implement due to cognitive challenges, interfering symptoms, and/or lack of skills on how to use or access key resources. as such, teams will need to translate cdc guidelines into more concrete behavior examples and use various means to model such behaviors visually. these may include demonstrating recommended hand washing techniques; personalized strategies for length of handwashing; use of disinfectant within the home, especially when living with others; specific guidance on how to navigate the environment if leaving the residence, such as understanding what more than six feet spatially looks like; application and removal of face masks; and modifying how one interacts with neighbors. such teaching may occur inperson while standing outside of the residence, or could be reviewed through videoconference if telehealth is possible. the mental health team should be aware of each client's pcp or help them establish care. it is important to coordinate with primary care, communicate about new respiratory symptoms, and advocate for evaluation and covid- testing as indicated. clients with respiratory symptoms should be advised to call pcp or er ahead rather than just showing up. in addition, coordinating with pcp and specialists may be needed to ensure ongoing treatment of chronic medical conditions in the midst of increased system strain and/or office closures, particularly for conditions that are correlated with a more severe coronavirus illness course (hu et al. ) . clients without housing, phones, or computers will face particular challenges getting their medical care needs met. behavioral health providers making outreach visits can be trained to assess vital signs. in some cases, funds have been allocated for purchasing communication hardware and/or data plans for clients in need. county and state public health departments are a resource for guidance on ppe recommendations in different settings, access to covid testing, and may have quarantine sites for those who are homeless or do not have sufficient space to isolate. public health departments should be contacted when clients are positive for covid, particularly if the client may have trouble following isolation guidelines secondary to impaired insight or judgment. public health may elect to conduct contact tracing and consider clients interactions at a mental health center, housing unit, or shelter. smoking increases both the risk of contracting covid- and the severity of illness. because the coronavirus targets the lungs, there is an increased urgency to quit smoking or vaping, or at least reduce use. this is an excellent time for mental health providers to focus on clients' efforts to quit. multiple medications are both effective in promoting smoking cessation among people with psychosis, and safe to use (not associated with increased risk of adverse neuropsychiatric side effects). in large clinical trials, varenicline appears to be the most effective medication to support smoking cessation among people with psychosis, but bupropion and nicotine replacement are also effective (anthenelli et al. ). combination nicotine therapy should also be considered, as this may increase the likelihood of success (stead et al. ). the clinical team should be apprised when pharmacotherapeutic interventions for smoking cessation are initiated, as mood and suicidal ideation should be monitored. clients should be advised that support is available through phone and texting services from - -quit-now ( - - - ), a free national phone service that routes the caller to the state line associated with caller's area code, and resources are also available from the american lung association, - -lung-usa ( - - - ), and the national cancer institute ( - u-quit ( - - ). in addition, there are a multitude of online resources to connect people to support groups and recommendations, including a government-sponsored website with information in english and spanish for adults and teenagers who smoke (smokefree: home) and a site from the american lung association, with a variety of tools to help quit both smoking and vaping (freedom from smoking) . apps may be particularly useful at this time. myquit coach offers different approaches to quitting smoking and community support. smoke free provides different techniques to quitting smoking, plus options and graphs to track cravings. virtual medication management visits should also be considered, as in-person visits pose a health risk not only to clients and providers, but also to elderly or medically-compromised individuals who live with clients or accompany them to clinic visits. there are unique challenges for telepsychiatry medication management visits for the treatment of psychosis and, to the extent possible, these should include video assessment. first, the evaluation of most medication side effects-including akathisia, parkinsonism, dystonic reactions, and tardive dyskinesia-is limited to self-report in telephone encounters. metabolic self-monitoring should be encouraged, especially among antipsychotic-naïve clients starting their first medication trial. clients with scales at home can weigh themselves and report these measures to the psychiatric care provider or nurse during the virtual encounter. second, the pandemic increases the risk of disruption to pharmacotherapy treatments. psychiatric care providers should review medication adherence and work with clients to ensure that they have an adequate supply of all both psychiatric and medical prescriptions, and a plan for refilling medications. the risks and benefits of a large supply of potentially lethal medications such as lithium or tricyclic antidepressants need to be weighed. weekly medication dispensing is still recommended for clients at high risk for suicide. for clients who have medications dispensed or observed weekly or more often, psychiatric providers might consider changing this medication support from in-person visits to daily phone calls. family support in picking up medications, pharmacy delivery services, and outreach by cmhc staff to drop off medications while observing from a safe distance are options to consider. there are two groups of clients who require special considerations with respect to pharmacotherapy management: those receiving long-acting injectable (lai) antipsychotic medications and those receiving clozapine. injections require physical proximity, yet proper ppe may not be reliably available to cmhc providers. clinics should provide large, well-ventilated areas for the administration of intramuscular injections and nurses should follow local ppe recommendations. it may be feasible to move clients from biweekly injections to other similar injectable formulations that can be given every weeks, or even every weeks. alternatives to in-person visits for lais should be considered on a case-by-case basis, as some clients may be able to tolerate a switch to oral medications during the period of reduction of in-clinic services, particularly if coupled with support from family or other natural or housing supports. there are several challenges in continuing high-quality clozapine treatment. treatment with clozapine in the prepandemic period required regular absolute neutrophil count (anc) monitoring (weekly for months, then bi-weekly for months, then monthly for the duration of treatment) to reduce the risk of a potentially life-threatening side effect of severe neutropenia. in the context of covid- , the clozapine risk evaluation and management strategy (rems)-the fda-mandated national program for reporting and monitoring clozapine treatment and adverse events-has published new guidelines for anc monitoring. the goal is to reduce the risk of contracting and/or transmitting covid- through laboratory visits (clozapine product manufacturers group ). the revised guidelines allow clients to continue receiving clozapine without a current anc. frequency of anc monitoring for any client should be determined using a shared decision-making process and should consider the risk of contracting covid in their community, the individual's risk of poor prognosis due to age and chronic medical conditions, their need to isolate due to covid- diagnosis or recent exposure, and their risk of severe neutropenia. at a minimum, clients should always be screened for covid- symptoms before in-person visits at the clinic or the lab. in most cases, it would be prudent to continue monitoring clients at their assigned frequency if their ancs have fallen below normal thresholds within the past months, or respective criteria for benign ethnic neutropenia (https ://www.cloza piner ems.com/cpmgc lozap ineui /rems/pdf/resou rces/anc_table .pdf). given that the highest risk for severe neutropenia is within months of clozapine initiation, clients in this phase warrant strong consideration for continued regular monitoring. for clients in biweekly or monthly phases of anc monitoring, the low risk of severe neutropenia makes a decision to forego regular monitoring a reasonable alternative, however a careful risk/ benefit evaluation needs to be conducted for each individual client. a decision to consider pausing anc monitoring for those no longer in weekly monitoring is consistent with a recently published consensus statement on the use of clozapine during the covid- pandemic (siskind et al. ) . along with reducing the anc testing frequency, it may be appropriate to increase the dispensed amount of clozapine up to -day supplies, based on a careful safety assessment of the individual client, with additional consideration of local pharmacy practices and insurance approval. additional challenges when initiating clozapine include monitoring vital signs for orthostatic hypotension and tachycardia, and monitoring for the increased risk of myocarditis. during the first month, serial troponins and c-reactive protein (crp) should be added to the weekly blood draw. lab monitoring should be accompanied by a targeted review of systems for myocarditis (e.g. chest pain, dyspnea, weakness, fever) and screening for other common side effects such as constipation, dizziness, weight gain, and sialorrhea. finally, it is important to remind clients taking clozapine for any duration that fever is a symptom shared with both severe neutropenia and covid- , and that if they develop a fever, they require urgent laboratory testing in order to rule out clozapine-associated neutropenia. in routine pharmacotherapy, lab tests are often required to measure therapeutic drug levels, monitor for renal or hepatic impairment, and screen and monitor for other side effects, including adverse metabolic effects. such monitoring may also be disrupted during the covid- pandemic, requiring adjustments to treatment. a client's laboratory may not be open or have reduced hours, or they may face barriers to getting to the lab. the psychiatric care provider and team should work with the client to weigh risks and benefits of each test for continued monitoring and consider the feasibility of alternative medications that do not require monitoring. even among clients who maintain ongoing services through multiple modes of care, as outlined above, behavioral health care can be enhanced or extended with asynchronous or selfguided technologies, including online resources and communities, technology-focused treatment adaptations, text messaging interventions, and provider-supported use of mobile health (mhealth) apps (andersson and cuijpers ). first, providers may extend services by coaching clients to access curated online resources, such as those offered by healthrelated, government, non-profits and advocacy organizations (e.g., mental health america ; national alliance on mental illness ; centers for disease control and prevention ). second, providers may consider adapting typical treatment strategies in a manner that involves increased client engagement with ordinary technologies, such as social media, videoconferencing platforms, or email, providing education and learning aids when necessary. other digital technologies such as smartphone applications can be used for direct mental health services, but the effectiveness of these interventions is enhanced by human support (mohr et al. ) . text messaging is highly accessible to individuals with serious mental illness. many individuals with smi own a device capable of texting (campbell et al. ) , and they use this feature at rates similar to the general population (noel et al. ) . text messaging has been repurposed to encourage illness management (granholm et al. ) , support medication adherence (montes et al. ) , and most recently, to provide ongoing therapeutic interaction with a designated member of the clinical team, i.e. a "mobile interventionist" (ben-zeev et al. ) . while text messaging offers the advantages of familiarity, ubiquity, and efficiency (schwebel and larimer ) , administrators must develop policies and procedures related to sms treatment guidelines prior to implementation and clinical adoption. providers should always use secure, encrypted platforms, establish protocols to protect client privacy, establish clear communication to clinic staff and clients about the parameters of text messaging (e.g., whether or not / access is available), and obtain informed consent when using text messaging. establishing these prerequisites in a cmhc that has not offered text messaging may take some time, but the asynchronous communication of text messages has several advantages. using this medium, providers can maintain ongoing interactions with multiple clients, and clients can access support in a discrete manner. other forms of digital health technologies allow clients to self-deliver evidence-based interventions. a growing body of research supports the use of smartphone apps to provide clients ongoing access to interventions. unfortunately, a few of the apps with the strongest evidence that have been designed specifically for users with serious mental illness are not yet publicly available. two such interventions-focus (ben-zeev et al. ) , which targets schizophrenia self-management, and prime (schlosser et al. ) , which targets social connection and depressive symptoms-have demonstrated efficacy and high rates of engagement in randomized trials. however, recent developments may assist providers in choosing an mhealth app for other clinical concerns-e.g. anxiety, insomnia, mindfulness-in the immediate term. psyberguide (neary and schueller ) is a non-profit project that publishes ratings of digital health apps along several categories, including credibility (e.g., the strength of empirical evidence for the app and its interventions), user experience (e.g., the design and overall experience for users), and transparency (e.g., clarity of an app's policies protecting user data, psyberguide ). mindtools.io (mindtools.io ) similarly provides ratings of popular digital mental health apps according to quality, credibility, research evidence, and security. providers can use these resources to better advise clients that are looking for mhealth support tools to use during disrupted clinical services. the covid- pandemic has indelibly shaped our healthcare system and our world. community mental health clinics are demonstrating resilience in the face of a mass trauma, and systems have the opportunity to experience posttraumatic growth as we begin to emerge from the pandemic. many of the changes that are being implemented to maintain care continuity during the pandemic can and should be maintained-at least in part-in its wake. experts are projecting that we will continue to see broader adoption of and applications for technology in behavioral health care moving forward (ben-zeev ) and that this new, more flexible and technology-enhanced model of care can benefit our clients' functional recoveries (ben-zeev et al. ) and may help to redress the mental healthcare disparities for underserved and marginalized populations (schueller et al. ). these include greater flexibility and creativity in the way that care is delivered, with a spectrum of options for remote and in-person care; greater integration of behavioral health and physical healthcare for existing conditions; tertiary prevention of contagious illnesses due to increased risk of exposure and deleterious health effects; increased collaboration and shared decision-making related to lai and clozapine use; updating safety plans and psychiatric advance directives to include new technologies and broader support systems; greater inclusion of natural supports; and integration of digital health interventions to treat primary and secondary psychiatric symptoms. to limit interpersonal contact, healthcare providers are rapidly pivoting to telehealth, encouraged by new centers for medicaid and medicare services' reimbursement codes for telehealth services (centers for medicare & medicaid services ). notably, cmhcs in states that have not elected to expand medicaid may consequently have more limited access to the practices and resources recommended here and may, as a result, observe higher rates of care discontinuity and/or poorer clinical outcomes during the pandemic response. providers and administrators have climbed a steep learning curve in a short timeframe. given that experts are projecting recurrent outbreaks, healthcare providers and mental health administrators will want to establish decision trees for determining medical, psychiatric, and social risks to diverse cmhc clients with corresponding care delivery options that balance risk to the individual, the clinical team, and the public. in particular, greater penetration of e-mental health may address both acute needs during the covid- crisis and chronic needs after the crisis subsides. policy makers and clinical administrators should attend not only to the emergent clinical gaps of today but also ways in which covid-related changes might inform future sustainable workflows, which will be particularly important if outbreaks are recurrent. funding dr. buck is currently supported by a career development award also from nimh (k mh ) as well as a narsad young investigator award from the brain and behavior foundation. priorities for the us health community responding to covid- . jama: the journal of the internet-based and other computerized psychological treatments for adult depression: a metaanalysis neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (eagles): a double-blind, randomised, placebo-controlled clinical trial. the lancet videoconferencing psychotherapy: a systematic review telephone-delivered psychosocial interventions targeting key health priorities in adults with a psychotic disorder: systematic review the digital mental health genie is out of the bottle mobile health (mhealth) versus clinic-based group intervention for people with serious mental illness: a randomized controlled trial a technology-assisted life of recovery from psychosis remote "hovering" with individuals with psychotic disorders and substance use: feasibility, engagement, and therapeutic alliance with a textmessaging mobile interventionist cell phone ownership and use among mental health outpatients in the usa medicare telemedicine health care provider facts racial health disparities and covid- -caution and context ocr announces notification of enforcement discretion for telehealth remote communications during the covid- nationwide public health emergency addressing the covid- pandemic in populations with serious mental illness examining health literacy levels in homeless persons and vulnerably housed persons with mental health disorders persecutory delusions: a cognitive perspective on understanding and treatment treatable clinical intervention targets for patients with schizophrenia mobile assessment and treatment for schizophrenia (mats): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations for telehealth to succeed, privacy and security risks must be identified and addressed stressed over covid- ? text new hotline for help from local counselors. the southern illinoisan prevalence and severity of coronavirus disease (covid- ): a systematic review and meta-analysis telepsychiatry in the assessment and treatment of schizophrenia cognitive therapy of schizophrenia: guides to evidence-based practice e-mental health: a rapid review of the literature internet-based cognitive behavioral therapy with real-time therapist support via videoconference for patients with obsessive-compulsive disorder, panic disorder, and social anxiety disorder: pilot single-arm trial systematic review of telehealth interventions for the treatment of sleep problems in children and adolescents mental health and covid- -information and resources about mindtools.io. retrieved supportive accountability: a model for providing human support to enhance adherence to ehealth interventions a short message service (sms)-based strategy for enhancing adherence to antipsychotic medication in schizophrenia home-based delivery of variable length prolonged exposure therapy: a comparison of clinical efficacy between service modalities state of the field of mental health apps use of mobile and computer devices to support recovery in people with serious mental illness: survey study app guide. retrieved telepsychiatry: overcoming barriers to implementation efficacy of prime, a mobile app intervention designed to improve motivation in young people with schizophrenia policy determinants affect telehealth implementation use of digital mental health for marginalized and underserved populations using text message reminders in health care services: a narrative literature review. internet interventions the need for telepsychiatry and e-mental health in publicly-funded mental health systems consensus statement on the use of clozapine during the covid- pandemic does low self-esteem predict depression and anxiety? a meta-analysis of longitudinal studies safety planning intervention: a brief intervention to mitigate suicide risk nicotine replacement therapy for smoking cessation comparing in-person to videoconference-based cognitive behavioral therapy for mood and anxiety disorders: randomized controlled trial covid- and health equity-a new kind of "herd immunity high-yield cognitive-behavior therapy for brief sessions: an illustrated guide ethical approval in the past years, dr. jarskog has received research grant funding from auspex/teva, boehringer-ingelheim, and otsuka; he has served as a consultant to uptodate and bracket. no other authors have conflicts of interest to disclose. all authors certify responsibility for the content of this article. this work does report on research involving human participants or animal subjects and did not require ethical approval from an institutional review board. key: cord- -gejo xdb authors: tekeli-yesil, sidika; kiran, sibel title: a neglected issue in hospital emergency and disaster planning: non-standard employment in hospitals date: - - journal: int j disaster risk reduct doi: . /j.ijdrr. . sha: doc_id: cord_uid: gejo xdb work organization and relationships have changed over recent decades. following the recent covid- pandemic, the norms concerning work-related standards will likely change even more significantly. there has been a shift away from standard employment to non-standard employment (nse), which includes fixed-term, part-time, on-call, agency-related employment, dependent self-employment, dispatch, and temporary employment, etc. in nearly every sector. the health sector is no exception. however, the effects of non-standard employment on the disaster preparedness of health systems, particularly on hospitals’ emergency and disaster plans, have not yet been adequately studied. most crucial themes are engagement of non-standard employees in emergency and disaster planning and response, and the impact of non-standard employees in expanding hospitals’ capacity in large-scale events. this short communication paper aims to discuss this neglected issue in hospital emergency and disaster planning. in order to see whether nse is considered in hospital disaster and emergency plans, two hospital disaster and emergency planning guidelines—the hospital incident command system, and the hospital emergency response checklist developed by the world health organization—were assessed regarding nse in their respective contexts. although these guidelines are comprehensive tools for hospital preparedness, nse is not specifically considered in any of them. however, it is essential that nse, with its trade-offs, is considered in disaster plans to maintain an effective implementation of them. further research and actions are necessary, especially after the covid- pandemic, to identify how this reflection should be conducted and to supply evidence for further measures and revising emergency and disaster planning guidelines. globally more than . million health workers are working for improving the health of populations. who defines health workers as "all people engaged in actions whose primary intent is to enhance health" ( , ). in another document of who health workers were defined in broader terms as "all workers in the health services, public health and in related areas, and workers who provide support to these activities" ( ) . even though, international standard classification of occupations (isco), which classifies health work force as "health service providers" and "health management and support workers", is used in many countries, many ministries of health uses their own classification systems, as the breakdown provided by isco for health workers is not very detailed. health service providers comprises the people who deliver services, such as physicians, nurses, midwifes, laboratory technician etc. health service providers account for % of all health workers globally. health management and support workers covers people who are not engaged in the direct provision of services, such as administrative professionals, computing professionals, clerical workers, drivers etc.( ). of the healthworkers, some are working in hospitals in diverse job categories, positions and employment status. employment status is usually classified as standard and non-standard forms of employment (nse). nse is generally defined based upon its differences from standard employment, which is considered as full-time and permanent work with a contract between the worker and employer ( ). nse includes fixed-term, part-time, oncall, agency-related employment, dependent self-employment, dispatch, and temporary employment ( ; ). standard employment has been evolving into non-standard employment (nse) in nearly every sector ( , ) for example in australia nse share (%) of the workforce between and had changed from % to % ( ) . there is no data available at global level for reporting on nse in health sector ( ), but some studies in different countries j o u r n a l p r e -p r o o f showed that non-standard forms of employment, such as part time employment, in the health sector are also increasing, despite their challenging characteristics as a vital part of the sector ( , , , , ) . for example, in australia, even in late 's nonstandard employees accounted for % of the workforce of the private hospitals in australia, while public hospitals had a much lower proportion of nonstandard employees ( %) ( ) . . nse has been considered to have a positive impact on economic growth, but it is also often referred to as precarious employment due to potential adverse consequences regarding the health and well-being of workers ( ) . nse can have a variety of effects depending on the type of work arrangement, the individual employee profile, and the context of the workplace, sector, and country. there are few studies assessing the impacts of nse in the health sector. according to these studies part time working, which is a form of nse, affected many aspects of the health sector. these effects were either positive or negative, such as increasing the productivity, hence contributing to the quality of services ( ) , or achieving higher patient outcomes in preventive services such as cancer screening or diabetic management ( ) , and adverse implications for the workforce such as more negative perceptions regarding workplace (less autonomy, fewer opportunities for self-development) and less favorable work attitudes (less engagement, job involvement, and affective commitment ( ) , or on the contrary better psychological well-being and more satisfaction( ); these effects have been increasingly discussed globally in many studies. however, there are many other negative and positive consequences of nse for communities, organizations, institutions, and individuals, which should be discussed and considered. specifically, the impacts of nse on the disaster preparedness of health systems, particularly on hospitals' emergency and disaster plans, have not been adequately studied thus far. nse-related data and the potential influences of its procedures also need to be evaluated both during and after the pandemic to gain knowledge and learn lessons for better planning and preparedness for future events. considering that the number of people affected by disasters and the estimated damage caused by them has risen since the middle of the twentieth century ( ), hospitals should be better prepared to face emergencies and disasters and overcome various j o u r n a l p r e -p r o o f challenges during this process. appraising the condition and status of employees is important during the preparedness process. inclusiveness of workforce, evaluation of needs, and keeping all capacities active and effective through a comprehensive occupational health and safety approach will empower the workforce in the health sector, which has a vital function during normal times as well as disasters. thus, this short communication paper identifies and discusses the neglected issue of nse in hospital emergency and disaster planning to point out a further research need. all sorts of natural and technological hazards and complex emergencies have direct or indirect effects on human health and well-being. the recent pandemic has indicated once again that health systems have a vital role in responding to these disasters, and hospitals are among the primary components of health systems. the impacts of disasters on the health systems include unexpectedly high numbers of deaths, injuries, or illnesses in the affected community; destruction of local health infrastructure and routine health services; effects on the environment leading to the danger of communicable diseases and food shortages; mental health problems; and spontaneous or organized population movements ( ). hospitals differ from other workplaces in many ways, especially in the context of disasters due the impact of disasters on the health systems. health services should continue functioning after disasters due to the vital functions they perform, and in many cases, they must increase their capacity to respond to casualties. however, they can face structural and non-structural damages due to various hazards, and, consequently, health services may be affected when they are most in need. health workers themselves and families can be also thus, hospitals require special attention in the disaster preparedness of communities. several actions should be implemented to help hospitals become resilient to hazards and function during/after disasters. the establishment of hospital emergency and disaster plans is among these actions. however, developing preparedness at the individual, institutional, or communal level is always a challenging issue ( , ). many factors, such as limited resources, lack of political will, and deficiency in communal/institutional/individual support or awareness, have an impact on health systems and hospitals. many of these challenges have been acknowledged and discussed ( ). in addition to these commonly discussed factors, changes in the work relationships of nse might complicate the challenges of making hospitals resilient to hazards and prepared for disasters, if they are not considered during the preparedness process. nse in hospitals has been common among healthcare personnel as well as other personnel ( , , , , , ) .further, hospitals have many types of nse, especially in non-medical areas, such as office work, cleaning, catering, and technical support.. all personnel in hospitals, medical and non-medical, should be involved in disaster planning. typically, attention is given to medical staff; however, ancillary and management staff members are also essential for hospitals to function ( ). thus far, literature has focused primarily on the negative aspects of non-standard employment in the context of disasters. nevertheless, considering that during the recent pandemic, many countries' health systems increased their capacity with non-standard employees, new evidence or arguments might emerge regarding the contributions of nonstandard employment to better planning for disasters and response to them. due to the irregular working conditions of non-standard personnel, such as working hours, at home working or holding multiple jobs, it might be a trade-off to assign them to critical positions in the emergency and disaster plans. this might end with allocating personnel ineffectively and inefficiently. during large scale emergencies and disasters, all existing human resources are critical, even those who are not working at the hospitals, such as general practitioners (gps) and volunteers, and they should be linked with plans ( ) . working in emergencies and disasters requires some flexibility and adaptation. for example, many health care providers who worked during hurricanes katrina and rita reported that they were employed in unusual roles or were asked to work with populations, such as pediatrics or geriatrics, to which they were not accustomed ( ) . similar examples were experienced during the covid- pandemic ( ) . on the one hand, personnel with non- in the hics, it was mentioned that it is important to ensure that all employees and medical staff receive training and understand their role(s) and responsibilities for an incidence response. repeated meetings and training were suggested to ensure the involvement of all personnel in the process and planning. calling additional staff and staff shift changes were considered and described in the guideline. however, volunteers and external support teams were identified for special consideration in engaging and linking them to planning and training. there was no specific statement about personnel with non-standard employment arrangements in any part of the guideline. the hospital emergency response checklist, as the name suggests, is a checklist rather than a guideline. it encompasses the essential actions to be taken for a prepared hospital. briefing hospital staff on their roles and responsibilities, identifying methods of expanding hospital inpatient capacity, and recruiting and training additional staff (e.g., retired staff, reserve military personnel, university affiliates, students, and volunteers) were described among key components. however, there was no specific statement about personnel with non-standard employment arrangements in any part of the checklist. in addition to these two internationally used guidelines, we checked a national guideline. the hospital non-standard employment is becoming more common in the health sector and hospitals. its impact on health systems and the service they provide, and on personnel, has been increasingly discussed globally. . additionally, excessive home-work interface requirements of health workers and related solutions need to be evaluated, for example, in the recent pandemic situation. these studies will illuminate non-standard conditions to be considered in future preparedness and response plans. . using telehealth or medicine to carry on some services that would be necessary during disasters might be just one of these solutions. there is no evidence yet on these positive or negative potential effects. after responding to disasters, emergency and disaster plans of the relevant sector or institution and the guidelines that these plans were based on are revised considering the lessons learned and needs. considering the covid- pandemic, now is the ideal time to start collecting data and producing evidence for revising plans and guidelines; in this endeavor, nse should be one of the primary topics. j o u r n a l p r e -p r o o f health workers in the world health report -working together for health international labour office. non-standard employment around the world: understanding challenges, shaping prospects non-standard workers have poorer physical and mental health than standard workers institutions and the prevalence of nonstandard employment socio-economic review casual and temporary employment in nsw regional hospitals rising part-time work in the academic pediatric workforce in canada casual work in nursing and other clinical professions: evidence from australia labour utilisation in queensland hospitals what is precarious employment? a systematic review of definitions and operationalizations from quantitative and qualitative studies productivity, quality, and patient satisfaction: comparison of part-time and full-time primary care physicians effect of part-time practice on patient outcomes part-time versus full-time work superbugs versus outsourced cleaners: employment arrangements and the spread of health care-associated infections where are general practitioners when disaster strikes? emergency preparedness and professional competency among health care providers during hurricanes katrina and rita: pilot study results the experiences of health-care providers during the covid- crisis in china: a qualitative study the lancet covid- : protecting health-care workers key: cord- -jf dnllj authors: tang, catherine so-kum; wong, chi-yan title: factors influencing the wearing of facemasks to prevent the severe acute respiratory syndrome among adult chinese in hong kong date: - - journal: prev med doi: . /j.ypmed. . . sha: doc_id: cord_uid: jf dnllj background. the global outbreak of the severe acute respiratory syndrome (sars) in has been an international public health threat. quick diagnostic tests and specific treatments for sars are not yet available; thus, prevention is of paramount importance to contain its global spread. this study aimed to determine factors associating with individuals' practice of the target sars preventive behavior (facemask wearing). methods. a total of adult chinese residing in hong kong were surveyed. the survey instrument included demographic data, measures on the five components of the health belief model, and the practice of the target sars preventive behavior. logistic regression analyses were conducted to determine rates and predictors of facemask wearing. results. overall, . % of the respondents reported consistent use of facemasks to prevent sars. women, the – age group, and married respondents were more likely to wear facemasks. three of the five components of the health belief model, namely, perceived susceptibility, cues to action, and perceived benefits, were significant predictors of facemask-wearing even after considering effects of demographic characteristics. conclusions. the health belief model is useful in identifying determinants of facemask wearing. findings have significant implications in enhancing the effectiveness of sars prevention programs. a new and highly infectious disease in humans, the severe acute respiratory disease syndrome (sars), has created a major public health threat in many countries. within months since its first appearance in asia in mid-february of , the world health organization (who) has already received reports of the outbreak of sars in countries on all five continents [ ] . the clinical symptoms of sars are nonspecific, including high fever, dry cough, breathing difficulties, muscle pain, and generalized weakness. the incubation period can last from to days, thus enables symptomless individuals to transmit the disease through either close person-to-person contact or travel from one city to another city in the world. the mortality rate of sars is about - %. only recently has the causative agent of this disease been found. the latest multicountry laboratory findings have confirmed that a new pathogen, a member of the coronavirus family never been seen in humans, is the cause of sars [ ] . however, the exact transmission route of the disease is still unknown, and quick diagnostic tests as well as specific treatments are also not yet available. under these unknown circumstances, prevention is of particular importance in containing the global spread of this new infectious disease. this study aimed to examine factors affecting hong kong people's practice of preventive behaviors against sars. findings from this study would provide pertinent information in designing and implementing sars prevention programs not only for hong kong, but for other countries as well. hong kong was one of the hardest hit area during the global outbreak of sars in and has accounted for almost % of the probable cases and deaths of sars. at the beginning of the local outbreak of this disease in early march of , mainly health care workers who treated the index patients were infected with the disease [ ] . very soon, new cases were reported among close contacts of known patients, and the disease then quickly spread to the community. local health authorities have since stepped up various prevention and intervention activities against further spread of the disease [ ] . at the community level, health authorities have launched large-scale public health education programs about the disease, issued preventive health guidelines to health care workers and the general public, suspension of classes for schools and universities, prompt isolation of infected individuals, and ordering of probable infected individuals to quarantine themselves at home for days. at the individual level, health advice is given on ways to prevent contracting and spreading of sars. the suggested sars preventive behaviors include ( ) maintaining good personal hygiene (covering nose and mouth with a tissue when sneezing or coughing and washing hands immediately afterward with liquid soap), ( ) developing a healthy lifestyle with proper diet, regular exercises, adequate rest, and no smoking, ( ) ensuring good ventilation at home and in the office, and ( ) wearing facemasks, especially for those with respiratory tract infections or those caring for them. despite all these efforts, an average of - new infected cases and about five deaths of sars were reported daily. the disease continued to affect both health care workers, as well as individuals from the community until june . researchers have argued that the practice of preventive behaviors by individuals is one of the most effective ways in disease prevention and health promotion [ ] [ ] [ ] . with environmental and policies support, these individual preventive behaviors can pass on to effective population-level prevention efforts [ , ] . for example, public education and media campaigns that disseminate health messages and information, environmental manipulation that provide necessary facilities, and national policies that make available economic incentive or reimbursement can motivate many individuals in the community to practice the desired health behaviors. thus, various psychosocial approaches, such as the health belief model [ ] , the theory of reasoned action [ ] , the social cognitive model [ ] , the protection motivation theory [ ] , and the stages of change model [ ] , have been put forward to predict the practice of preventive behaviors at the individual level. among various psychosocial approaches, the health belief model is one of the most widely used and provides the necessary conceptual framework for this study. this model postulates that the practice of preventive behaviors is a function of the degree to which individuals perceive a personal health threat and the perception that particular preventive behaviors will be effective in reducing the threat [ ] . in applying this model to understand the practice of sars preventive behaviors, perceived health threat refers to individuals' perception of their vulnerability to contracting sars (perceived susceptibility) and that this disease has serious consequences (perceived severity). individuals' be-lief that the practice of the suggested sars preventive behaviors will prevent sars depends on ( ) whether they think these preventive behaviors will be effective (perceived benefits), ( ) whether the cost of undertaking these behaviors (perceived barriers) exceeds the benefits, and ( ) whether there are any cues (cues to action) to trigger these behaviors. cues to action can be internal, such as the perception of a body state, or external, such as the influence of mass media and social pressure. there is ample support for the health belief model in explaining individual practice of preventive behaviors. this model helps to predict the practice of preventive dental care [ ] , dieting for obesity [ ] , aids risk-reduction behaviors [ ] , breast self-examination [ - ] , sunscreen use [ ] , and participation in a broad array of health screening programs such as obtaining a mammogram to screen for breast cancer [ - ] and undergoing genetic testing for cancer susceptibility [ , ] . prevention programs that draw on this model to effect behavioral change have also yielded positive results in increasing various health behaviors to prevent dental problems [ ] , osteoporosis [ ] , and diabetes [ ] . overall, perceived benefits, perceived barriers, and perceived susceptibility are the three most powerful components of the health belief model in influencing whether individuals practice different preventive behaviors [ , , ] . it is also found that the actual risk of developing a disease is a much less important predictor of individual preventive behaviors than is perceived susceptibility [ ] . other than psychosocial predictors, there is also an accumulation of literature documenting the importance of associations between individuals' demographic characteristics and their practice of preventive behaviors [ , - ] . in general, women and more affluent and better educated individuals are more likely to practice the suggested preventive behaviors. an inverted curvilinear relationship is found between age and practice of preventive behaviors. typically, young children are often compliant in adopting various preventive behaviors, which tend to decline in adolescence and adulthood but improve again among older people. findings in relation to marital status and ethnicity are inconclusive. the purposes of this study were twofold. the first objective was to determine the rates of the target sars preventive behavior in adult chinese with different demographic background. among various sars preventive behaviors suggested by local and international health authorities, this study focused on the wearing of facemasks. this target preventive behavior was chosen for this study because it was specific to this disease and involved deliberate effort of individuals. based on past related literature, it was expected that men, the younger age group, and individuals with low educational attainment would be less likely to wear facemasks. the second objective of this study was to test the efficacy of the health belief model in predicting the practice of the target preventive behavior. based on past related literature, it was expected that perceived susceptibility, perceived severity, perceived benefits, perceived barriers, and cues to action were significant predictors of facemask wearing. this study was conducted between march and april , , in hong kong, when there was clear evidence that sars had started to spread from health care workers in hospitals to the community. at the time of the study, the exact causative agent and route of transmission of the disease were still not yet fully known [ ] . local health authorities had since implemented enhanced infection control procedures in all hospitals and cohorting of sars patients [ ] . they had also stepped up communitywide sars prevention and intervention activities. data for this study were obtained using a community telephone survey of adult chinese (aged and above) residing in hong kong during the specified period. random-digit dialing of the local residential telephone directory for was used to select respondents. this directory covered all listed telephone numbers in all regions of hong kong, where over % of the households owned at least one or more telephone lines. telephone surveys were conducted by trained telephone interviewers and took about min. when telephones were busy or there was no answer, three follow-up calls on different time or dates were attempted before substituting a new telephone number. the response rate was %, and the sampling error was . percentage points. a total of adult chinese were surveyed, and their demographic information are summarized in table . compared to the hong kong population census data [ ] , the present sample included more women as well as individuals with university education and higher monthly personal income. similar differences in demographic characteristics between telephone surveys and census data were also noted in previous local telephone surveys [ ] . the present sample comprised . % men and . % women. about half of them aged between and years, . % between and years, . % between and years, and . % were older than years. among them, % were single, % were currently married, and the remaining were either separated, divorced, or widowed. slightly more than half of the respondents completed high school education and worked either full time or part time. another . % of the respondents were homemakers, . % were students, . % were retirees, and . % were unemployed. respondents were asked to indicate how often in the past week they wore facemasks to prevent contracting and spreading sars. they responded with either ''never,'' ''occasionally,'' or ''most of the time.'' the first two responses were coded as '' '' and the last response was coded as '' '' for subsequent statistical analyses. this was assessed by three items: ( ) whether respondents felt vulnerable to contracting sars, ( ) whether they knew or had close contact with any individuals infected with sars, and ( ) whether they had respiratory infection syndromes such as sore throat, dry cough, fever, muscle ache, and shortness of breath. respondents answered with ''yes'' or ''no'' responses, and affirmative responses were then summed to form a total score. high total scores represent respondents perceiving themselves as being highly susceptible to contracting sars. respondents indicated on two -point scales the degree to which they were fearful of sars ( as ''not at all fearful'' to as ''very fearful'') and worried that hong kong would become a quarantine city because of the widespread of sars to the community ( as ''not at all worried'' to as ''very worried''). high mean scores of these two scales represent respondents perceiving sars as having very severe adverse consequences. respondents were asked to indicate on a -point scale the degree to which they agreed wearing facemasks could prevent contracting and spreading sars ( as ''strongly disagree'' to as ''strongly agree''). high scores indicate respondents perceiving great benefits in wearing facemasks. respondents were asked to rate on two -point scales the degree to which they had difficulty in obtaining facemasks ( as ''not at all difficult'' to as ''very difficult'') and the level of discomfort when wearing them ( as ''not at all uncomfortable'' to as ''very comfortable''). high mean scores of these two items indicate respondents perceiving great barriers in wearing facemasks. this was assessed by asking respondents to indicate on two -point scales the degree to which the local government and their family members encouraged them to wear facemasks ( as ''strongly disagree'' to as ''strongly agree''). high mean scores of these two scales represent respondents having great awareness of environmental cues to wear facemasks. respondents were also asked about their sex, age, educational attainment, marital status, and personal monthly income. statistical analyses in this study were conducted using spss . software. descriptive statistics for demographic characteristics of respondents were generated and compared with the hong kong population census data ( table ). the rates of wearing facemasks were determined for individuals with various demographic characteristics. bivariate logistic regression analyses were then conducted to determine whether the practice of facemask wearing differed within each demographic characteristic (table ) . a multivariate logistic regression analysis was also performed to test the health belief model and to identify significant predictors of the target preventive behavior. odds ratios (ors) for each predictor were estimated from the logistic regression (table ) . demographic variables of the respondents were entered in the logistic regression first to control for their effects before testing the health belief model. then, predictor variables were entered simultaneously in the next block of the regression. the predictor variables consisted the five components of the health belief model: perceived sus-ceptibility, perceived severity, perceived benefits, perceived barriers, and cues to action. overall, . % of the respondents reported consistent wearing of facemasks to prevent contracting and spreading sars. table . ) were more likely to wear facemasks to prevent sars within their own demographic groups. results also showed that sex (v = . , p < . ), age (v = . , p < . ), and marital status (v = . , p < . ) had significant subgroup differences in the target preventive behavior. a logistic regression with odds ratios was conducted to test the efficacy of the health belief model in predicting the wearing of facemasks to prevent sars. in block i, demographic factors of sex, age, and marital status were entered first to control for their effects. results showed that this block was significant (v = . , p < . ). the five components of the health belief model were entered in the next block, and they were significant in predicting facemask wearing, even after considering effects of demographic factors (v = . , p < . ). the final model of the logistic regression analysis is presented in table . with the exception of perceived barriers, all estimated coefficients were in the expected direction. all odds ratios were above . . in summary, respondents who were women (or = . ; ci = . , . ), who belonged to the older age group (or = . ; ci = . , . ), who were married (or = . ; ci = . , . ), who felt more susceptible to contracting sars (or = . ; ci = . , . ), who perceived sars as having more serious consequences (or = . ; ci = . , . ), who believed greater benefits in wearing facemasks (or = . ; ci = . , . ), who encountered greater barriers in wearing facemasks (or = . ; ci = . , . ), and who were more aware of environmental cues (or = . ; ci = . , . ) were more likely to wear facemasks. results showed that three of the five components of the health belief model, namely, perceived susceptibility, cues to action, and perceived benefits, were significant predictors. perceived severity and perceived barriers were not significant predictors of facemask wearing when other factors were also considered. this study examined how various psychosocial factors are associated with the practice of the target sars preventive behavior among adult chinese in hong kong. similar to previous research [ - ] , this study found the health belief model useful in identifying major determinants of the wearing of facemasks to prevent contracting and spreading sars. in particular, findings showed that three of the five components of the model, namely, perceived susceptibility, cues to action, and perceived benefits, were significant predictors. review studies of the health belief model have also found that among the five components, perceived susceptibility and perceived benefits are the more powerful components in predicting preventive behaviors [ , ] . the present results showed that compared to those with a low level of perceived susceptibility, individuals feeling personally very vulnerable to contracting sars were . times more likely to wear facemasks. it was also found that individuals who had strong beliefs in the effectiveness of wearing facemasks to prevent sars were . times more likely to wear facemasks than those who did not have these beliefs. furthermore, this study showed that cues to action were as an important predictor as perceived susceptibility. those who were more aware of environmental cues were . times more likely to wear facemasks than those who perceived few cues to action. previous studies have also indicated that cues to action in the form of advice from family members and health care professionals are also very important factors in increasing various preventive behaviors [ ] . the remaining two components of the health belief model, perceived severity and perceived barriers, were found to be nonsignificant determinants of the target sars preventive behavior in this study. in spite of previous literature indicating the powerfulness of perceived barriers in influencing the practice of preventive behaviors [ , , , ] , this component did not significantly predict the wearing of facemasks in the present sample of adult chinese. it might be that this target preventive behavior is relatively easy to perform, despite some discomfort and inconvenience. individuals can have complete control of the behavior and can take off the facemasks anytime they want or feel uncomfortable. facemasks are cheap and easy to obtain, except during the early outbreak of sars. thus, there are relatively less perceived barriers in wearing facemasks as compared to participating in screening or immunization programs. this study also found that perceived severity of sars did not significantly predict facemask wearing. earlier studies on cancer noted that perceived severity was not related to preventive behaviors, as cancer is uniformly thought of as a serious disease [ ] . on the other hand, it would also be argued that the failure of perceived severity to predict the target sars preventive behavior might be related to individuals' underestimation of the potential of this disease to become a global epidemic. during the early stage of the local outbreak, this disease affected mainly health care workers, a few index patients, and their close contacts [ ] . the serious consequences of this disease with increasing prevalence and mortality rates might have been overlooked. thus, the public was not motivated or did not anticipate the need to practice the suggested sars preventive behavior. similar to existing literature on preventive behaviors [ , - ] , this study also found that individuals' demographic characteristics were significant predictors of facemask wearing. results showed that men, single people, and the - age group were significantly less likely to wear facemasks to prevent sars than women, married people, and individuals aged between and years. although statistically nonsignificant, odds ratios also showed that individuals with less than university education and very low personal income were also less likely to wear facemasks. researchers have argued that the low rates of preventive behaviors among young, single, and low education men may be related to their inadequate knowledge about the disease, peer influences, risk-taking tendency, and perceived immortality and immunity to various disease [ , ] . this study found that about . % of the respondents consistently wore facemasks to prevent sars. in other words, despite the rapid spread, increasing death toll, and vigorous preventive activities, close to % of the respondents did not practice the target sars preventive behavior. for some subgroups, the noncompliance rates were even higher. as there are evidences that sars may emerge again both locally and across countries [ ] , there is a need for hong kong, as well as other countries, to further enhance the effectiveness of related prevention and intervention measures to contain the disease. results of this study had significant implications for sars prevention programs. it is suggested that individuals' perception of their own vulnerability to the disease should be emphasized by highlighting the global outbreak and debilitating health consequences of sars, which not only affect health care workers, older people, those with chronic illness, or individuals of a particular ethnicity. public education and media campaigns should be conducted regularly in schools, workplaces, and community settings to disseminate the latest findings of sars. the public should be made aware that there is no specific treatment and vaccination for this disease; therefore, individuals must take own precautions to prevent contracting the disease. it should also be emphasized that at the individual level, facemask wearing remains one of the most effective ways to prevent contracting and spreading sars [ ] . indeed, studies have shown that communications that highlight perceived susceptibility and simultaneously increase the perception that a particular health behavior will reduce the health threat are successful in promoting various preventive behaviors [ , , ] . the present study also showed that environmental cues to wear facemasks are very important. other researchers have argued that environmental manipulation and policies support are crucial to translate individual to collective preventive efforts [ , ] . environmental cues can be in the form of signs and posters to remind people to wear facemasks and should be placed in prominent areas in schools, at worksites, and in public places. advice, recommendation, or encouragement from health care professionals are also useful to increase individuals' likelihood to wear facemasks. policies that require the wearing of facemasks in certain locations (e.g., inside hospitals) or for those who have respiratory symptoms will also ensure individuals to practice the desired preventive behaviors. finally, it is also particularly important to target sars prevention activities at those who are less likely to practice these behaviors, namely, men, single individuals, and the younger age group. this study had several limitations. first, there were concerns about the representative of the sample. this study used telephone surveys to collect data and failed to include individuals who were without home telephone lines or not at home during the surveyed period. comparison with the census data showed that the present sample comprised more women as well as more affluent and better educated individuals, who were also more likely to practice the suggested sars behaviors. in view of this, the present sample might have higher rates of facemask wearing than the general population. second, only retrospective self-reports of respondents were collected without external verification, and results might be subject to recall and social desirability bias. third, this study focused on the five key components of the health belief model to predict rates of facemask wearing. it did not investigate individuals' knowledge of and emotional responses to sars, which have also been found to significantly influence the practice of preventive behaviors [ , ] . lastly, the measurement of the target sars preventive behavior was crude and without any contextual information. it is possible that rates of facemask wearing might differ at home, in the workplace, or in public places. despite these limitations, this study provided pertinent information on factors influencing the practice of the target sars preventive behavior. findings have significant implications in enhancing the effectiveness of prevention activities against the global spread of sars. update: outbreak of severe acute respiratory syndrome-worldwide a novel 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inconsistency key: cord- -u zj zf authors: wallar, l. e.; mcewen, s. a.; sargeant, j. m.; mercer, n. j.; garland, s. e.; papadopoulos, a. title: development of a tiered framework for public health capacity in canada date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: u zj zf • select sars reports were qualitatively analyzed for usage of “capacity”/“capacities”. • public health capacity can be sub-divided into individual capacity components. • these components can be organized into five tiers to build a capacity framework. • this framework can be used to guide capacity assessment and building efforts. in the early s, successive canadian public health crises revealed that public health systems were ill-equipped to meet unexpected, increased population health demands. in , the severe acute respiratory syndrome (sars) pandemic created a panicked state of preparation in anticipation of a high mortality rate and broad geographical spread. although this was not realized, large gaps in capacity to meet potential emergency health demands were revealed. after sars, the first and only comprehensive and objective review of the canadian and ontario public health systems was conducted. it strongly emphasized the need for enhanced public health capacity and a strong public health workforce to prevent the occurrence of future crises. over time, these efforts have been hampered by a muddied understanding of what public health capacity actually means. e the objective of this study was to regain a clear understanding of the components of public health capacity, and how they relate to a stronger public health system. in this study, twelve publicly available canadian or ontario sars reports published between and were identified using a key informant (executive director of the association of local public health agencies ( e )), and were accessed from internet websites between october and january (n ¼ ) using the names of the reports, or the reports' commissioners or committee chairs as key words. for a complete listing of these reports, see supplementary data in appendix a. manifest content analysis was used to analyze the use of the terms "capacity" and "capacities" related to public health. tables of contents, chapter headings, executive summaries, recommendations and terms that were unrelated to public health (e.g. bed capacity) were excluded. the remaining terms were coded by report name and type of capacity by lew. for example, epidemiological capacity was coded as "epidemiological". all coding was independently reviewed by seg. disagreements between reviewers related to the addition, deletion and naming of codings (n ¼ ) were discussed and consensus was achieved. similar codes were deductively organized by lew into families that represented separate components of public health capacity. families and their codes were reviewed by seg and consensus was achieved through critical discussion. these families were then organized by lew and ap into a tiered public health capacity framework where capacity within each tier builds upon the capacities within the preceding tiers, and moves from the individual to the systems level. here, we present this framework of public health capacity that identifies individual components and suggests how they relate to and support one another for the purpose of enhancing overall capacity in public health systems. seventeen components of public health capacity were identified and organized into five tiers, namely: human resources; foundation components; program components; integrative components; and enhanced public health (fig. ). this framework arranges the components of public health capacity from the individual to the systems level. human resources form the bottom tier of the capacity framework as they provide the necessary manpower, skills and competencies to support the succeeding tiers, and ultimately maintain and improve population health and wellbeing. their critical importance was discussed by all of the reviewed reports. as the national advisory committee on sars and public health noted, "no attempt to improve public health will succeed that does not recognize the fundamental importance of providing and maintaining in every local health agency across canada an adequate staff of highly skilled and motivated public health professionals." the foundation components of public health capacity provide the necessary underlying infrastructure by supporting one another to effectively fulfill the programmatic and integrative public health functions, and maintain the smooth functioning of the public health system. for example, research and k* capacity is supported by partnerships and collaboration between various public health stakeholders on the same tier level. this tier also supports succeeding tiers. for example, epidemiology and surveillance capacity is supported by timely access to quality data and information, collaborative linkages, investigative research, common reporting structures, and modern disease information systems. the program components of public health capacity represent more traditional public health functions that support the integrative capacity components which combine these functions. for example, emergency management is supported by public health laboratories that are equipped to handle high volumes of testing, field epidemiologists, surveillance systems and networks, infection control standards, and training of front line workers. the integrative components of public health capacity include systems-level, complex, and inter-connected public health functions that require the integration of human resources, foundation and program capacity components in order to be effective. emergency management refers to planning and preparedness, detection and response, and control and mitigation of outbreaks, emerging and resurgent public health threats, unforeseen events, epidemics, and health crises. population health management refers to meeting community needs and responding to public health issues and challenges within the local and provincial public health systems. delivery of programs and services is primarily discussed in relation to ontario's public health units although the need for human, physical and financial resources applies to public health organizations as well. governance is related to policy and planning procedures, strategic capacity, leadership and management, performance management, and risk assessment and planning. these complex capacity components require the integration of the lower-tiered capacity components to impact local, provincial and federal public health capacity. as the standing senate committee on social affairs, science and technology noted, "capacity enhancement is a broad term which encompasses a number of areas: surveillance systems; fig. e tiered framework of public health capacity and its components. the components of public health capacity were identified through analysis of the usage of public health-related "capacity" or "capacities" in post-sars reports. these components were organized into five tiers from the individual to the systems level. k* indicates knowledge exchange, management and transfer. bold font indicates the five tiers. emergency preparedness and response; human resources; public health laboratories; information technology; communications and research." public health capacity exists at all societal levels, and is supported by human resources, and foundation, program and integrative components. as each component is enhanced, public health systems are able to more effectively meet public health needs. this study presents a cumulative conceptual framework of public health capacity where each capacity tier builds upon the capacities of the underlying tiers from the individual to the systems level. this organization is consistent with the united nations development programme's capacity assessment and development framework and lafond, brown and macintyre's health sector capacity framework. , by organizing public health capacity components in this way, it emphasizes how individual capacity components relate to and support one another. this is in contrast to other discussions of capacity in public health that have a more singular focus on specific capacities such as epidemiology or health promotion. , based on this framework, capacitybuilding efforts are predicted to be potentially more impactful when directed at the lower tiers (human resources, foundation) as these tiers support capacity within the above tiers. this framework is intended for a diverse audience including public health professionals, organizations, academia, government, and professional associations who are interested or engaged in assessing and enhancing the types of public health capacities that are present and/or absent within their respective units. we suggest that this framework can be applied by each actor using an iterative, developmental approach according to the following steps: ) identify the capacity components that individuals, agencies, and systems should possess given their particular mandate; ) identify the capacity components that individuals, agencies, and systems possess, and examine how these components relate to the other capacity components in the framework; ) identify the components that individuals, agencies, and systems do not currently possess in relation to the ideal state; and ) examine the potential for building these capacities internally or externally via strategic partnerships with other actors who already possess these desired capacities. this conceptual framework provides a common structure of public health capacity components that can be utilized by any actor to better coordinate and target capacity-building efforts to specific components identified using the framework. this framework has some limitations. it is descriptive in nature rather than prescriptive with respect to how each component should be enhanced in current public health systems. it is incumbent on each user of this framework to decide how best to modify and apply it to meet their particular needs. the framework is based on government and governmentcommissioned sars reports that reviewed the canadian and ontario public health systems with an emphasis on community public health outbreaks and emergencies. certain components such as maternal and child health were not addressed in these reports and are therefore not included in this framework. lastly, this framework has not been validated using any real-world applications or scenarios. as this framework is implemented, it will be important to collect and receive feedback on its utility and applicability. as public health continues to meet new and existing challenges, enhancing public health capacity with a renewed focus on where individual capacity components exist within the system, and how these can be effectively leveraged through strategic partnerships will strengthen the ability of public health systems to maintain and improve population health into the future. final report: spring of fear. toronto: ministry of health and long-term care mapping capacity in the health sector: a conceptual framework the development and pilot testing of a rapid assessment tool to improve local public health system capacity in australia four approaches to capacity building in health: consequences for measurement and accountability rethinking validity and reliability in content analysis learning from sars: renewal of public health in canada e a report of the national advisory committee on sars and public health. ottawa: health canada standing senate committee on social affairs, science and technology. reforming health protection and promotion in canada: time to act. ottawa: government of canada united nations development programme bureau for development policy. capacity assessment and development in a systems and strategic management context development policy assessment of epidemiologic capacity in state and territorial health departmentseunited states assessing public health capacity to support community-based heart health promotion: the canadian heart health initiative, ontario project (chhiop) not required (no human participants or animals were used to conduct this research). none. key: cord- - glw pir authors: lloyd, helen m.; ekman, inger; rogers, heather l.; raposo, vítor; melo, paulo; marinkovic, valentina d.; buttigieg, sandra c.; srulovici, einav; lewandowski, roman andrzej; britten, nicky title: supporting innovative person-centred care in financially constrained environments: the we care exploratory health laboratory evaluation strategy date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: glw pir the cost cares project aims to support healthcare cost containment and improve healthcare quality across europe by developing the research and development necessary for person-centred care (pcc) and health promotion. this paper presents an overview evaluation strategy for testing ‘exploratory health laboratories’ to deliver these aims. our strategy is theory driven and evidence based, and developed through a multi-disciplinary and european-wide team. specifically, we define the key approach and essential criteria necessary to evaluate initial testing, and on-going large-scale implementation with a core set of accompanying methods (metrics, models, and measurements). this paper also outlines the enabling mechanisms that support the development of the “health labs” towards innovative models of ethically grounded and evidenced-based pcc. the world health organisation defines universal health care as that 'which all citizens can access without incurring financial hardship' [ ] . many nations fail to provide this as a basic human right, health promotion as an approach aims to inform, influence, and support people, communities, and organisations to improve health. supporting people to increase control over their health is in essence health promoting, both for the individual and society [ , ] . hp activities can work in synchronicity with pcc if developed in partnership with the person, taking into consideration their life context and socioeconomic conditions [ , ] . cost action 'cost cares' was funded by the eu commission to create the impetus in both the research and development required to design and test innovative exploratory health laboratories (ehls) to implement pcc and hp across the eu. this paper sets out a strategy for evaluating them. to understand how the ehls might work to deliver pcc, hp, and cost outcomes, it was first necessary to develop programme theories (pts). pts describe how interventions (service, treatment, policy) are thought to work by specifying the ways in which they produce outcomes. they are a set of causal relationships often referred to as "if-then" statements. they can also be written or represented graphically to show the relationships between cause and effect. pts are also useful for understanding both the positive and negative impacts that can occur when interventions are implemented. they are often accompanied by logic models, which help plan and evaluate interventions based on their internal logic, and the role of context in supporting successful delivery and evidence acquisition. we created evidenced-based pts to specify how ehls would deliver pcc, hp, and cost outcomes through the critical enablers detailed in the we-care roadmap (see figure ). repeated here for clarity the critical enablers are ( ) information technology (it), which describes the use of computers or other computerized devises to store, transmit, and receive data to support pcc planning and care coordination, for handling and communicating health and evaluation data, and for delivering pcc and hp interventions. ( ) quality measures, such as organizational processes, that ensure health services increase the likelihood of the desired health outcomes consistent with current scientific knowledge, which take into consideration an individual's preferences, and ensure that health services are effective, affordable and accessible to all citizens. ( ) infrastructure to create the necessary resources and structures that support the shift from health systems that are excessively hospital-centric and biomedically-oriented, to those which value continuity, responsiveness, and multidimensionality in community care, e.g., shifts in staffing, training, and delivery of care. ( ) incentive systems that reward pcc processes and outcomes, such as personal health goals, pcc plans, improvements in patient self-efficacy and experiences of care, and hp activities. this will require an expansion and critical revision of existing system-based biomedically driven performance indicators. ( ) contracting strategies that define and endorse pcc incentive systems and infrastructural support and efficiencies for ehls, purchasing strategies and contracts between payers and providers of healthcare that promote the alignment in organisational goals based on pcc, hp, and cost containment. ( ) cultural change that represents shared assumptions, values, and beliefs that govern how people behave in an organisation. receptiveness or readiness to change is considered a prerequisite for ehls. as other critical enablers are modified within a given ehl, cultural change towards pcc, hp, and cost containment may present as either a pre-requisite and/or a natural consequence of development. the addition of this sixth critical enabler represents the importance of organizational culture in achieving pcc and cost stability. upon establishing agreed definitions of the above enablers, the next step was to hypothesize how these might work to support the aims of an ehl. following this step, the literature was searched to detect evidence for the hypothesized statements, referred to as 'if-then' statements. to expedite this process, tables of 'if-then' statements were compiled, which, in keeping with the evaluation methods of critical realism [ , ] , permitted the compilation of patterns of causal chains within the ehl. for example, if condition x is in place (e.g., practitioners are incentivized to engage in shared decision making with patients), then outcome y might follow (e.g., patients will feel like they are taking an active role in rehabilitation planning), thus improving service user experiences of pcc [ ] . this task facilitated exploration of how the critical enablers interacted with pcc and hp to improve quality pcc and cost containment (see figure ). the points at which pcc and hp intersect with each of the critical enablers in figure are referred to as intersection points (e.g., pcc and information technology (it)). this section describes the considerations and necessary steps for evaluating and implementing ehls to improve quality pcc and cost containment. first, the practice of pcc is explored, and then the role of critical enablers is illustrated. a number of controlled studies have been performed comparing pcc to usual care [ , [ ] [ ] [ ] . the core components in the interventions have been to listen carefully to the patient's illness narrative and to mutually agree on a health plan. the true case story (see figure ) previously published in a position paper demonstrates how the patient narrative can open up and reveal information needed for the patient and the professionals to be able to agree on a relevant health plan [ ] . this is concordant with the theory and philosophy that pcc is based on starting with each person's capability and wish to take responsibility for their own health. the true case below is a vignette based on a real person to illustrate how pcc can be applied in practice through a worked example. upon establishing agreed definitions of the above enablers, the next step was to hypothesize how these might work to support the aims of an ehl. following this step, the literature was searched to detect evidence for the hypothesized statements, referred to as 'if-then' statements. to expedite this process, tables of 'if-then' statements were compiled, which, in keeping with the evaluation methods of critical realism [ , ] , permitted the compilation of patterns of causal chains within the ehl. for example, if condition x is in place (e.g., practitioners are incentivized to engage in shared decision making with patients), then outcome y might follow (e.g., patients will feel like they are taking an active role in rehabilitation planning), thus improving service user experiences of pcc [ ] . this task facilitated exploration of how the critical enablers interacted with pcc and hp to improve quality pcc and cost containment (see figure ). the points at which pcc and hp intersect with each of the critical enablers in figure are referred to as intersection points (e.g., pcc and information technology (it)). this section describes the considerations and necessary steps for evaluating and implementing ehls to improve quality pcc and cost containment. first, the practice of pcc is explored, and then the role of critical enablers is illustrated. a number of controlled studies have been performed comparing pcc to usual care [ , [ ] [ ] [ ] . the core components in the interventions have been to listen carefully to the patient's illness narrative and to mutually agree on a health plan. the true case story (see figure ) previously published in a position paper demonstrates how the patient narrative can open up and reveal information needed for the patient and the professionals to be able to agree on a relevant health plan [ ] . this is concordant with the theory and philosophy that pcc is based on starting with each person's capability and wish to take responsibility for their own health. the true case below is a vignette based on a real person to illustrate how pcc can be applied in practice through a worked example. pcc for mr. g was facilitated via various critical enablers, detailed in the following: information technology: the medical documentation and information (in the patient records) as well as the commonly formulated treatment and health plan are digitalized and accessible to mr. g and his providers in a way that he comprehends and can agree or ask questions about. in formulating the health plan, mr. g was supported by a digital patient decision aid [ ] . health information technology (it) systems support the smooth flow of information between services, and to and from citizens and their families. artificial intelligence might facilitate this and help improve interactions with patients [ ] . quality measures: mr. g was invited to download an app after his first myocardial infarction where he can follow the development of symptoms and well-being and contact health care services for help and support with formulating his personal health plan. contracting strategies, incentives, and infrastructure: the infrastructure supported cumulative documentation according to the criteria for pcc. this was linked to incentive payments for the whole team. this type of incentive payment includes quality measures (care plans) that are sanctioned and contracted between the provider and commissioner organisation. program theories (pts) are useful ways in which to facilitate an understanding of how complex interventions work; in this case, how the critical enablers could work with pcc and hp interventions to generate cost containment and quality pcc outcomes. table provides worked examples of pts referred to as 'if-then' statements with explanatory 'because' statements and associated suggestions for assessment or measurement. instruments and methods to assess pts should be carefully selected and the use of mixed methods is advised. knowledge base and practical constraints will add to the existing complexity of measurement and evaluation. the type of design employed can help remedy some of these issues. for example, beginning with small-scale and qualitative assessment will help determine what to measure and how to measure it, and what improvements to expect. ensuring measures or assessments capture professional and patient partnership work in care planning is key for emphasizing the importance of this for pcc. the following pts are presented here as examples of a larger body of work (available from the first author) conducted to inform the design and evaluation of ehls. table presents seven different types (a-g) of evidence-based pts that could shape the design of an ehl. type a (contracting strategies for quality and cost outcomes) pts represent how contracting strategies could operate at macro and meso levels to support quality pcc and contain cost. in the two examples provided, 'alliance' or 'partnership' models contract to deliver an ehl based on shared or co-designed pcc and hp objectives to improve quality pcc and costs. this fosters trust and productivity based on collective ownership and the sharing of risk and reward within ehl. a mixture of quantitative and qualitative measures of delivery and management team dynamics, and progress towards aligned goals (e.g., pcc health plans), and costs over time could be used to ascertain the success of the contracting strategy. these enablers provide causal mechanisms for cost and quality outcomes at macro and meso levels within the ehl. type b (incentives and contracting strategies for quality pcc resulting in cultural change) pts represent the potential for contracting strategies combined with incentives to improve cost and quality outcomes by providing incentives at multiple levels across the ehl. for example, if cost effectiveness is measured across the whole care chain with the savings provided to all participants, this creates the potential to act as an incentive towards aligned pcc and cost goals. to combat perceptions of unfairness in the equal distribution of savings across the system, objective measures of effort will need to be employed. these measures, however, should to be balanced against the knowledge of the operational context. for example, settings low on staff resources may seem to have contributed less towards the achievement of savings across the chain. ensuring that contextual knowledge supports objective measurement will help communicate the conditions of contributors towards the savings gained and shared. long-term planning and monitoring, active communication, and shared goals will help mitigate against perceptions of unfairness. redistributing resources based on savings can help achieve the stated organization goals and thus improve the sector's efforts where these are perceived to be lacking. these seemingly radical shifts align to the principles of fair division and social choice [ ] . over time, resultant cultural change across the system could be operationalized as permanent transformation of routines/habits. measures of pcc and hp routines/habits, savings distribution, and measures of patient experience of care could help establish if this strategy is beneficial. type c (contracting strategies, incentives, and quality measures for cost and quality) pts combine contracting strategies with incentives and quality measures to effect change in quality and costs. these build on type a and b pts by, for example, suggesting that if contract payments are made at the same time to all providers and tied to measures of pcc and hp, this fosters trust and productivity by reducing the misalignment and unproductive competition between partners and reduces transaction hazards operating at macro and meso levels within the system. type d (incentives for quality pcc) pts work at the micro level with incentives applied equally to all delivery staff irrespective of hierarchy or professional grouping [ , ] (e.g., patient feedback forms at clinic and ward levels). for quality pcc outcomes to be achievable, incentives must ensure that the reward system motivates individuals to align their own goals with those of the organization (ehl) [ , ] . as the pcc approach is based on qualitative changes, financial incentives may not be the best type of incentive to test. it has been long recognized that financial incentives are positively related to quantitative performance (e.g., number of tasks completed) but not necessarily with performance quality [ ] [ ] [ ] [ ] . thus, ideally, particularly since pcc is based in an aristotelian ethics of virtues, the incentive systems should be a combination of financial and non-financial rewards (e.g., recognition, positive feedback from leaders, promotions, money, as well as target setting and performance evaluation itself) [ , ] . these rewards would be directed to all ehl members, since in "a complex network of interdependent relationships" [ , ] necessary for pcc implementation, it is difficult to identify an individual contribution. the success of micro-level incentives can be measured by carefully selected patient experience measures and focus groups. type e (incentives, quality measures for cost, and quality pcc) pts work by combining incentives with quality measures at macro and meso levels. for example, if a pcc quality measure is linked to an ehl accounting system and able to deliver cost containment information resulting from pcc processes, then the measure itself becomes the incentive. quality measures therefore act as both an aligned incentive and measurement of implementation. a pre-and post-comparison of costs associated with pcc quality processes analyzed against quality measure scores would provide an assessment of effectiveness. a benchmarking strategy against non-ehl settings may be an example of a measurement process being itself an incentive. it is important to note that the cost containment may not be immediate, as some costs may be incurred upfront and/or it may take time for outcomes to stabilize or become apparent. ehls employing longitudinal designs can help to account for these potential delays. type f (information technology for quality) pts provide examples of how it has the potential to improve quality. these pts work to support patient self-management through mobile technology, for example, through symptom monitoring or appointment reminders, to help people manage their own health [ ] . they may also operate to support the adoption of pcc electronic health records and care plans, which provide teams with the tools to maintain and share pcc information. measurement and evaluation of these mechanisms would be tailored to detect changes in patient self-management activities, team effectiveness, and resultant health system impact (e.g., reviews, appointments attended, etc.). in the current covid- context, remote monitoring of patients, video-linked consultations, and e-health interventions could provide an exciting opportunity to test the delivery of person-centred care remotely, with the potential to calculate costs compared to previous standard practice [ ] . type g (infrastructure for quality pcc) pts provide examples of how components of an organization's infrastructure could help result in quality care at meso and micro levels. at a meso level, if staff training is provided to enhance professional skills to support patient empowerment and enhance professional communication skills, this then has the potential to improve pcc delivery and experience of care. furthermore, using patient-reported measures to shape care planning and use of the feedback from these measures to improve staff training has the potential to embed the patient voice in quality improvement practices and shape equitable person-centred relationships between professionals and patients [ ] . a multitude of measures are available to measure these outcomes [ ] and for use in care planning in this way. however, sampling care plans with patient-reported outcome measures (prom) and interviews with professionals and patients would be insightful. these examples of pts are not comprehensive, but they illustrate how those developing ehls can use these and other mechanisms to design their interventions and corresponding evaluation strategies. for further guidance on the use of evaluation metrics and measures, see p c.org.uk. if "quality measures" are linked to pcc ideas and information systems (e.g., accounting system) and able to deliver information about cost containment or other quantitative indicators improvement against non-ehl settings (benchmarking), then the measurement process itself will be an incentive [ ] the measurement process has also the function of ex-ante control applied "quality measures" enabler the evaluation of ehls should address questions that will enable commissioners of health services and delivery organizations to implement, sustain, and scale up the innovations. key evaluation questions for the ehls will include those that probe pcc processes, practices, and patient experiences of pcc care as markers of quality pcc. the health outcomes measured should be relevant to the patient and their family, health care provider, and other decision-makers. key areas of interest in the implementation of pcc are changes in functional ability, experiences of care, self-efficacy, and cost. ehls will also be informed by wilson and cleary's [ ] model for integrating concepts of biomedical outcomes and measures of health-related quality of life: (i) biological and physiological factors, (ii) symptoms, (iii) functional status, (iv) general health perceptions, and (v) overall quality of life). specific questions (see figure ) will also probe the mechanistic relationship between the critical enablers and pcc and hp. these are referred to as intersection points. irrespective of the type of intervention, commissioners and policy makers require proof that the additional health care resources needed to make the procedure, service, or program available to those who could benefit from it are justified [ ] . the purpose of economic evaluation is to inform such funding decisions. an economic evaluation deals with both inputs and outputs (costs and consequences) of alternative courses of action, and is concerned with choices and consideration of the costs and benefits at multiple levels. ehls will therefore have to evaluate the main costs involved in the change of a healthcare system towards pcc and hp. weinstein [ ] identifies costs related to changes in the use of healthcare resources, changes in the use of non-healthcare resources, changes in the use of informal caregiver time, and changes in the use of patient time (for treatment). in a similar way, drummond et al. [ ] identifies health sector costs, other sector costs, patient/family costs, and productivity losses. measurement within economic evaluation expands beyond the healthcare system under study. according to weinstein [ ] , direct health care costs include all types of resource use, including professional, family, volunteer, or patient time, as well as the costs of tests, drugs, supplies, healthcare personnel, and medical facilities. non-direct health care costs include the additional costs related with the intervention, such as those for childcare (for a parent attending a treatment), the increase of costs required by a dietary prescription, and the costs of transportation to and from the clinic; they also include the time family or volunteers spend providing home care. citizen time costs include the time a person spends seeking care or participating in or undergoing an intervention or treatment. time costs also include travel and waiting times as well as the time receiving treatment. productivity costs include ( ) the costs associated with a lost or impaired ability to work or to engage in leisure activities due to morbidity and ( ) lost economic productivity due to death. the world health organization (who) recognizes quality health care in those organizations that have a high degree of professional excellence, with minimum risks, good health outcomes for patients, and efficient use of resources [ , ] . to promote the health of the population, the who recommends key objectives for continuous quality improvement in health care. these include the structuring of health services, the rational and efficient use of both human and financial resources, and the guarantee of professional competence to citizens in order to meet their needs. measures or questions relating to quality are likely to overlap and complement those relevant for cost containment (see figure ). is the ehl coordinating its activities around the person and their carers/family? are carers supported? are community assets are being deployed, including peers, social networks, and the voluntary sector? the evaluation of the ehls must contain the most suitable measures and approaches to answer the questions. quantifiable measures or questions can either be aggregated (single criterion analysis) or handled separately (multi-criteria analysis). careful consideration of the combination of qualitative and quantitative approaches is advised, particularly since different health systems display different capabilities in this regard. in terms of minimum design standards, at least two data collection points-pre-and post-intervention/implementation-are recommended. this is the minimum standard advised. should the availability of knowledge, skills, and resources be forthcoming, more complex experimental and implementation-focused designs could be undertaken upon careful consideration of the amount of preexisting evidence for pcc in that particular context or condition [ ] . ideally, monitoring and data collection will be continuous and with feedback to practice, with long follow-up periods to capture lasting changes in care delivery and outcomes. to account for the variance in ehls, a core minimum data set from each site with three categories of data is recommended: routinely collected audit data or similar (e.g., collected at country or hospital level); questionnaire data specifically collected for the ehl; and qualitative data to support implementation development. examples of suitable measures, depending on the focus of the changes in the healthcare system that are implemented, are given in table . as an ehl is scaled out in practice, it may be necessary to add new measurements to capture unanticipated and/or unintended changes. a metrics framework provides the structure for planning the sampling and timing of data collection during the evaluation of an ehl. it is likely that data could flow from different sources, e.g., routinely collected data and quantifiable data, surveys, and qualitative data. the pt will guide the sampling strategies for data collection, the timing of data collection, and the various units of analysis. qualitative approaches will always necessitate careful sampling because they are resource and time intensive. in contrast, an ehl may decide on a questionnaire to measure the experiences of all those using a service to canvas a broad view. the trade-off between qualitative approaches and more structured approaches involves considerations of depth versus breadth; different sampling strategies are required for different forms of data. as qualitative approaches are effective for determining "how and why" the ehl is working, it will be important to consider a range of perspectives. sampling should therefore aim for diversity in terms of ethnicity, social and economic status, age, disability, and health conditions. services may also decide to film or record care interactions for ongoing implementation and quality improvement activities, using purposeful samples or random selection. convenience and pragmatism will also play a role in any sampling procedure, which is common in applied health care research and evaluation, where time and resources are limited. the phasing of data collection will likely include baseline data and follow-up data to mirror the timeframes of the intervention. it might also be necessary (providing sufficient justification and acceptability from practitioners and patients) that focused data capture on a specific element of the delivery is added into the core set of measures at particular times. for example, if communication or shared decision-making was an improvement target, implementing a tool that specifically addresses this issue of relational care could be used as both the intervention and data collection [ ] . the potential to link health and social care data to understand an individual's pathway following exposure to an ehl will be determined by local ethical restrictions, data flow, and governance guidelines. linked data sets (or even unified data sets) allow for a longitudinal exploration of the impact of the intervention on service utilization (costs) and health using time series analysis or similar [ ] . analysis will be more powerful if compared to a control cohort (tracked by a unique identifier following explicit consent) of people who are part of a health lab. the use of techniques, such as propensity scoring, to identify and match control groups of service users are particularly helpful for this type of evaluation and service development [ ] . the analysis plan should be informed by the pts and shaped by the evaluation framework. in principle, three main stages of analysis are envisaged. the first stage will commence with univariate analysis to examine each variable or source of data (for example, acceptability of services as a measure of quality or use of care plans as a measure of it) independently. this could explore the time trends in say routinely collected data and the statistical properties of the data, e.g., the distribution of the data. parallel qualitative analysis could seek to surface emerging themes. in the second stage, for each ehl, the pt will be tested to check if it is functioning as expected. in the third stage, findings both within and across the ehls will be compared to answer the higher-order questions about the relationships between the quality of care and cost containment. working to understand trends in the data and other potential factors influencing outcomes (i.e., closure of a community hospital, or lack of out-of-hours primary care) will be a necessary effort. collaboration between academic and health science partners will facilitate a robust evaluation, linking efforts to capture patient experiences and outcomes with cost indicators. the ultimate result will be a more nuanced story of how the intervention is delivered, experienced, and the extent to which it is achieving change. in this regard, it is important to note that change may not be immediate. even if change is achieved quickly, impact on outcomes may require longer-term follow-up, especially, for instance, to demonstrate the cost-benefit ratio. to convince european societies and key decision-makers at a national and an eu level that the we-care roadmap is viable, reliable evidence from the ehls based on robust evaluation and implementation is required. many barriers and uncertainties may threaten the implementation of pcc. the first is the quality and accuracy of the pt that underpins the ehl model; whether it includes all key aspects needed to provide pcc, if it examines quality care and/or cost, and the extent to which it includes the enablers within the ehl. the model should also be appealing and promise significant benefits, in order to convince key stakeholders of the potential ehl. however, not only is the quality of the theoretical model important, the legitimacy and reliability of the person or organization presenting the model to its future users is also crucial [ ] . the engagement of authoritative local leaders who endorse the model to a range of stakeholders will be important to achieve early on in the process. this is likely to affect stakeholders' perception of its quality and validity [ ] , as well as its advantage over alternative solutions [ , ] . the ehls will affect people, their families, health professionals, and employees throughout the organization, including managers. thus, a bundle of incentives for different groups will probably be required. varied incentives, not only financial, as pay-for-performance, but also prospects of increased external recognition or legitimacy for participant organizations should be considered. the title of "the best provider", achieved by public benchmarking, could be an example. this requires accurate outcome measurement. incentive bundles can apply to three enablers of we-care roadmap: incentive systems, quality measures, and contracting strategies. the case-mix systems that are used in many european countries to finance hospital care are motivating providers to admit more patients, because the more patients they serve, the higher their income. if a hospital or a hospital ward agrees to become an ehl, the issue of contradictory incentives is likely to arise and must be overcome. for example, if, by implementation of an innovative community care ehl, more patients are cared for in the community, then the hospital will not receive money from the payer for those patients. the fixed costs of the hospital will remain, creating a deficit in the hospital system. a risk-reward sharing framework between the hospital and community provider could agree to cover hospital losses over the course of the project, but provisions for who will pay the fixed costs afterwards would need to be considered. involving key stakeholders from across the system will be important to provide strategies to overcome these conflicting issues. there should also be a distinction made between the average and the marginal cost of in-patient care. for example, the costs of a hospital ward (e.g., general medicine) are unlikely to differ significantly between a -or -patient occupancy. this means, that even if a treatment of a group of patients was organized outside of a hospital and the hospital infrastructure remained unchanged, the cost savings would be meagre or illusory. if, after introduction of the innovative care system, the medical infrastructure seemed unnecessary, then ehl employees would need to be motivated to support the ehl to ensure sustainability. the extent to which the organizational climate is favorable for ehl implementation must also be considered [ ] . the implementation climate is more evident and less stable than the organizational culture and is thus more susceptible to amendments. policies, procedures, and reward systems are those incentives that may effectively affect the implementation climate [ ] . the other fundamental ingredient of a positive implementation climate is the extent to which important actors perceive the current healthcare delivery model as intolerable or unsustainable and are motivated for change, defined as cultural readiness [ ] . the proposed model of the ehl should be compatible with stakeholders' own norms and values (culture), as well as with their priorities [ , ] . to maintain a positive climate for the implementation of ehls, important indicators related to citizen health, well-being, quality, costs, and other important factors should be presented to stakeholders. thus, both the climate for change and incentives and reward systems call for accurate, objective, and verifiable measures viable to reflect the real performance in pivotal areas. if measures do not meet these requirements, this could undermine implementation [ ] . measures must clearly communicate pcc goals and feedback to participants indicating the degree of goal achievement. to support pcc implementation and address potential barriers, each pt should be linked to a strategy with its own resources. resources include knowledge, time, money, training, and in some cases physical space. especially important is the access to widely understandable and convincing information and knowledge about pcc implementation, specifically about new work processes for the staff and the nature of care provided to patients and their social environment. if resources are not available, this creates a further barrier to implementation that must be effectively managed. organizational change begins with changes in individual behavior, although as numerous studies have shown, this is complex and challenging [ ] . ensuring the main actors do not perceive implementation of ehls as threats to their own interests is a critical issue to address. subjective interests are, however, not often easy to identify. powerful actors, in particular leaders who at multiple levels across the system represent the core activity of the pcc implementation, must include physicians, nurses, allied health and social care professionals, people, and their communities. in ehls, leadership should be transformational and innovative to create teams working to develop a workplace that is person centred. this is a key factor in the delivery and sustainability of pcc [ ] . if this is achieved, it will promote cultural change and the upskilling of existing employees. having several key people within the organization take on this role will ensure leadership sustainability. although these groups should support every change to augmenting healthcare quality, such as pcc, in reality, however, explicit or latent resistance can be a common problem [ ] . the medical and health professions are built on an ideology to protect and care for humanity over economic profitability and self-reward [ ] , but contradictions between altruism and professional self-interest have been established. the excessive self-interest of individual doctors or groups of physicians should be mitigated by professional self-regulation and self-control [ ] . since large-scale testing is the ultimate aim, it is assumed that a significant number of enabler elements will be in place when an ehl begins. as suggested earlier, the ehl will be underpinned by the pt that describes how the central work processes and independent actions of actors should be coordinated to deliver high-quality pcc. to be effective, the model, once elaborated, will require continuous adjustment not only to local environment factors but also to external and internal uncertainties emerging over time in each setting. thus, some feedback and regulatory mechanisms should be an integral part of the model. the development and improvement of ehls will be facilitated by a commitment to formative learning in response to the feedback from the evaluation data (data-driven improvement). there is a long tradition of using these methods to improve practice, and good evidence to suggest benefit [ ] . learning will vary by organization and setting. however, it will usually require a "plan-do-study-act" (pdsa) cycle or a similar process [ ] . this will typically involve action learning sets [ ] using quality improvement methodology [ ] . action learning sets are particularly suited to iterative complex intervention development as they focus on learning from interactions, thus providing a mechanism to reflect and problem solve. these skills are particularly important for health and social care professionals who are being asked to work in a different way, where this is likely to be challenging. . . co-design and participatory action for pcc emancipatory research designs have been a core feature of community development and strengths-based approaches in social care. such approaches value the lived experience and partnership with patients and the public in developing and evaluating services [ ] [ ] [ ] [ ] . research approaches based on these principles have in the past been subject to much derision but are now becoming recognized as critical to citizen-relevant and humanistic healthcare planning and evaluation, and align well with the philosophy of pcc. the uk standards for patient and public involvement in the planning and evaluation of health and social care are supported by academic, research, and government policy. involving patients and the public in the consultation and shaping of ehls is a core and fundamental standard we advocate. this paper laid out a comprehensive plan for the evaluation of exploratory health laboratories that aims to improve the quality of health care in the eu whilst also containing costs. the plan was developed by members of the we-care fp -funded project and cost cares cost action from a range of academic and professional backgrounds and different countries. this process identified pcc and hp as the solution, along with critical enablers to facilitate implementation. examination of the intersections among and between these enablers, as well as the impact on quality of care and cost of care, via evidence-based pts provides the justification for the design and incorporation of particular components into an ehl. furthermore, the paper also described how these components and ehls might be evaluated as complex interventions at micro, meso, and macro levels. this work and the resources it produced (www.costcares.eu) are intended to serve as a reference material for those considering setting up ehls or similar initiatives beyond the scope of this cost action. author contributions: h.m.l. was instrumental in leading the work of working group . this included development and supervision of the plan of work, data curation, preparation of the original manuscript and subsequent revisions. i.e. was core to working group and supported the writing, reviewing and editing of the manuscript. i.e. led the funding acquisition and contributed to the work of working group and critical development of the manuscript. h.l.r. is a member of working group and was responsible for data curation, manuscript revision with re-conceptualization of some aspects presented, and critical review of the final manuscript. v.r., p.m. and v.d.m. are members of working group and were responsible for data curation, manuscript review and critical revision. s.c.b. read versions of the manuscript and was responsible for reviewing the final manuscript. e.s. contributed to data curation, critical review of the manuscript and was responsible for editing and adding citations. r.a.l. helped to write the manuscript, supported the literature review and subsequent critical revisions of the final version of the manuscript. n.b. supported the work of working group through conceptualization and methodological input and was instrumental to the development and writing the original manuscript and subsequent reviews. all authors have read and agreed to the published version of the manuscript. the authors declare no conflict 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title: a “one health” approach to address emerging zoonoses: the hali project in tanzania date: - - journal: plos med doi: . /journal.pmed. sha: doc_id: cord_uid: emdlh d jonna mazet and colleagues describe their work in the tanzania-based hali project, which adopts the “one health” approach to address emerging zoonoses and that recognizes the interconnectedness of human, animal, and environmental health. nowhere in the world are these health impacts more important than in developing countries, where daily workloads are highly dependent on the availability of natural resources [ , ] . water resources are perhaps most crucial, as humans and animals depend on safe water for health and survival, and sources of clean water are dwindling due to demands from agriculture and global climate change. as water becomes more scarce, animals and people are squeezed into smaller and smaller workable areas. contact among infected animals and people then increases, facilitating disease transmission. water scarcity also means that people and animals use the same water sources for drinking and bathing, which results in serious contamination of drinking water and increased risk of zoonotic diseases. in addition, poor sanitation and animal management can result in fecal contamination of both animal and human food. when this situation is complicated by high hiv/aids prevalence, the impacts of otherwise minimally virulent or difficult-to-transmit pathogens can be catastrophic to families and entire communities, and ultimately to the environment through impacts on human capacity, natural resource management, and land use [ ] . the conditions of land-use change, water scarcity, and overlapping human, livestock, and wildlife populations are particularly prevalent in rural africa and near remaining wildlands. human population in sub-saharan africa doubled between and [ ] , and the african population and health research center predicts another doubling from levels to . billion by . such rapid population growth and consequent demands for natural resources are making african wildlands increasingly vulnerable to conversion to other land uses, such as logging, agriculture, and pasturage. a recent analysis by wittermyer et al. [ ] found that average annual population growth rates were higher in buffers to protected areas than in rural areas in africa and latin america. protected areas provide some of the last supplies of ecosystem goods and services for expanding human populations, including firewood, bush meat, clean water, medicinal plants, and areas of safety during civil strife. their porous edges also provide refuge for the vectors of zoonotic disease transmission. the interconnectedness of human, animal, and environmental health is at the heart of one health, an increasingly important prism through which governments, ngos (nongovernmental organizations), and practitioners view human health [ ] . an important implication of the one health approach is that integrated policy the health in action section is a forum for individuals or organizations to highlight their innovative approaches to a particular health problem. interventions that simultaneously and holistically address multiple and interacting causes of poor human health-unsafe and scarce water, lack of sanitation, food insecurity, and close proximity between animals and humans-will yield significantly larger health benefits than policies that target each of these factors individually and in isolation. by its very nature, the one health approach is transdisciplinary, since it is predicated on agricultural scientists, anthropologists, economists, educators, engineers, entomologists, epidemiologists, hydrologists, microbiologists, nutritionists, physicians, public health professionals, sociologists, and veterinarians working collaboratively to improve and promote both human and animal health. figure depicts the relationship among health, safe water, and food supply and their dependence upon plants, animals, and the environment, as well as the influences that interact to affect human health. this complexity necessitates a collaborative approach among professionals from multiple disciplines for the design of effective interventions. the hali project assessing and reducing the impacts of zoonotic diseases and resource limitation on health and livelihoods requires governments, ngos, and academic institutions to work with citizens to develop interventions that are cost effective, sustainable, and conservation minded. in , the health for animals and livelihood improvement (hali; http:// haliproject.wordpress.com/) project was initiated to test the feasibility of the one health approach in rural tanzania and to find creative solutions to these problems by investigating the impact of zoonotic disease on the health and livelihoods of rural tanzanians living in the water-limited ruaha ecosystem. hali, from the swahili word for state of health, addresses these complex disease and natural resources issues on a platform that recognizes that the health of domestic animals, wildlife, and people is inextricably linked to the ecosystem and natural resources on which all depend [ ] . the ruaha landscape is one of tanzania's largest wild areas, covering a region larger than denmark (. , km ). this sprawling ecosystem is of extraordinary conservation significance and supports approximately , elephants (loxodonta africana) and the continent's third largest population of critically endangered african wild dogs (lycaon pictus) [ ] . the socioeconomic importance of the ruaha region rivals its biological significance, as virtually all communities depend entirely on the natural resource base, and agriculture accounts for about % of these livelihoods [ ] . this importance is immediately apparent at the village level, where livestock are widespread, abundant, and central to traditional natural resource management. unfortunately, livestock-dependent households are among the poorest in the nation [ ] . this local poverty fuels the demand for illegal wildlife hunting for meat, another known driver for disease emergence [ ] . zoonotic diseases known to be of public health importance, such as rabies and rift valley fever, are present in wildlife, domestic animals, and people in tanzania [ ] ; however, the role of underdiagnosed diseases, such as bovine tuberculosis (btb), has only just begun to be characterized [ , ] . nearly , new cases of tuberculosis (human, bovine, or atypical strain) are diagnosed per year in tanzania [ ], with anywhere from % to % of tanzanian tuberculosis patients also infected with hiv [ ] . the extrapulmonary form of tuberculosis (eptb) in people, often associated with btb infection from animals, accounts for % of the reported cases in tanzania [ ] . therefore, bovine tuberculosis became a focal disease for the hali project due to its high livestock prevalence [ ] , wildlife data paucity, and the large, susceptible hivinfected human population living in close association with livestock and wildlife. additional priorities for hali were determined through gender-balanced interviews with affected communities, including village chair people; leaders of agricultural, water, and women's cooperatives; and heads and members of pastoralist households. an overwhelming consensus emerged from follow-up stakeholder meetings of diverse communities, including multiple levels of government (including public hospital physicians), nonprofit organizations, academic institutions, and citizens: a significant proportion of the rural population in the ruaha landscape is affected by diseases impacted by water supply, and these diseases are affecting health, agricultural productivity, food security, and biodiversity in the region. accordingly, the hali project is assessing the impact of the interactions between water and disease in the ruaha ecosystem by simultaneously investigating the medical, ecological, socioeconomic, and policy issues driving the system ( table ). the map in figure illustrates our multilevel approach, which includes: testing of wildlife, livestock, and their water sources for zoonotic pathogens and disease; environmental monitoring of water quality, availability, and use; assessing wildlife population health and demography; evaluating livestock and human disease impacts on table . the hali project's multilevel approach to assessing the impact of the interactions between water and disease in the ruaha ecosystem by simultaneously investigating the medical, ecological, socioeconomic, and policy issues driving the system. objective activities ronmental policy interventions to mitigate the impacts of zoonotic diseases. perhaps most importantly, the hali project is examining these issues in a common framework with specific emphasis on the interactions between them, instead of attempting to isolate a single issue. the hali project has identified bovine tuberculosis and brucellosis in livestock and wildlife in the ruaha ecosystem and is using this information to identify geographic areas with varying water availability where risk of transmission among wildlife, livestock, and people may be high. in addition, salmonella, escherichia coli, cryptosporidium, and giardia spp. that can cause disease in humans and animals have been isolated from multiple water sources used by people and frequented by livestock and wildlife. these data are now being used to examine spatial and temporal associations between landscape factors and disease and to identify risk factors and health impacts that may be mitigated through policy changes and outreach. preliminary findings also indicate that more than two-thirds of participating pastoral households do not believe that illness in their families can be contracted from livestock, and nearly half believe the same of wildlife. furthermore, when the hali project began working in this region, % of households did not consider sharing water sources with livestock or wildlife a health risk, illustrating the need for effective community education. the hali platform has reinforced the importance of the one health concept and provided lessons for the development of a new approach to global health. first, it is crucial to recognize that zoonotic pathogens are present and emerging in rural communities and that their emergence is spatially and temporally variable within these communities. most people living in high risk areas are not aware of the danger or what can be done to reduce it. in addition, transmission can be exacerbated by common animal husbandry and food and water handling practices ( figure ) [ ] . therefore, data collection strategies should include the evaluation of spatial, temporal, and demographic patterns of pathogen prevalence and disease in human, domestic animal, and wildlife populations in likely hotspots for disease emergence. the underlying water-and land-use determinants of disease and the social, economic, and cultural barriers to control and prevention must be explored [ , ] . while local stakeholders and international institutions actively involved in animal health, conservation, and livelihood assessment and improvement were quick to engage in hali, physicians and public health experts (local and international) have been slower, likely due to competing demands on time and resources already dedicated to addressing malaria and tuberculosis of human origin [ ] . concerns over the financial escalation of projects directly measuring pathogens in humans was also an obstacle to engaging medical professionals for these neglected diseases. second, the role of water in disease transmission and zoonosis emergence should be further explored. water scarcity increases work stress, especially in women and children, and brings animals and people together more frequently, increasing the likelihood of water contamination and transmission of infectious diseases. likewise, the manner in which water is used for agricultural and animal production affects worker health, food safety, and the health of those who drink and bathe in it. improving water safety and security, including sanitation, in ecologically appropriate ways that reduce disease risk will require a transdisciplinary approach in which economists, ecologists, epidemiologists, and engineers play important roles with public and animal health practitioners. finally, the determinants and consequences of zoonotic diseases, as well as the interventions to mitigate their deleterious effects, are all cross-sectoral. effective surveillance, assessments, and interventions are possible only by bridging the organizational gaps among institutions studying and managing wildlife, livestock, water, and public health. it is clear that education in global health, especially emerging zoonotic diseases, is urgently needed at all levels from research institutions to pastoralist communities. collecting detailed data regarding land use and agricultural practices, food consumption and water use habits, illness in animals and people, and access to health care will help appropriately tailor education efforts for priority diseases and pandemic prevention. the donor community should be encouraged to transcend disciplinary conventions and invest in holistic health projects that have the best chance of affecting change. data and statistics: causes of death the control of neglected zoonotic diseases: a route to poverty alleviation risk factors for human disease emergence global trends in emerging infectious diseases neglected disease research and development: how much are we really spending evaluating and managing zoonotic disease risk in rural tanzania livelihoods and protected areas in the ruaha landscape: a preliminary review hiv/aids and the environment: impacts of aids and ways to reduce them. a fact sheet for the conservation community isolation of african protected areas accelerated human population growth at protected areas edges contributing to one world, one health: a strategic framework for reducing risk of infectious diseases at the animalhuman-ecosystem interface building support for protected areas using a ''one health'' perspective setting conservation and research priorities for larger african carnivores agriculture sector development strategy budget survey / bushmeat hunting: deforestation, and prediction of zoonotic disease emergence the current epidemiology and control of trypanosomiasis and othe r zoonose s in tanza nia knowledge of causes, clinical features and diagnosis of common zoonoses among medical practitioners in tanzania national tuberculosis and leprosy programme tanzania ( ) annual report for trend in hiv prevalence among tuberculosis patients in tanzania, - isolation of mycobacterium species from raw milk of pastoral cattle of the southern highlands of tanzania tribal differences in perception of tuberculosis: a possible role in tuberculosis control in arusha, tanzania unhealthy landscapes: policy recommendations on land use change and infectious disease emergence the health paradigm and protected areas: linkages between people and their livelihoods, ecosystems and natural communities, and health and disease key: cord- -vuxzv eu authors: bennett, b. title: legal rights during pandemics: federalism, rights and public health laws – a view from australia date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: vuxzv eu pandemic influenza will cause significant social and economic disruption. legal frameworks can play an important role in clarifying the rights and duties of individuals, communities and governments for times of crisis. in addressing legal frameworks, there is a need for jurisdictional clarity between different levels of government in responding to public health emergencies. public health laws are also informed by our understandings of rights and responsibilities for individuals and communities, and the balancing of public health and public freedoms. consideration of these issues is an essential part of planning for pandemic influenza. s u m m a r y pandemic influenza will cause significant social and economic disruption. legal frameworks can play an important role in clarifying the rights and duties of individuals, communities and governments for times of crisis. in addressing legal frameworks, there is a need for jurisdictional clarity between different levels of government in responding to public health emergencies. public health laws are also informed by our understandings of rights and responsibilities for individuals and communities, and the balancing of public health and public freedoms. consideration of these issues is an essential part of planning for pandemic influenza. Ó the royal society for public health. published by elsevier ltd. all rights reserved. in his book 'blindness', josé saramago tells the story of a city struck by an epidemic of 'white blindness'. this is not the darkness or blackness that most of us associate with blindness. instead, in this blindness, everything is white, as if, according to one man in the early pages of the book, 'i were caught in a mist or had fallen into a milky sea'. those who are blind are placed in quarantine in a disused mental hospital, with food delivered to the main entrance three times daily. inside the hospital, the ugly side of humanity is revealed as the strong take control of the food supplies and assault the women. beyond the hospital walls, the epidemic, initially a trickle of baffling cases, spreads to affect the whole city until, finally, soldiers no longer maintain the quarantine and the blind leave the hospital. the story follows a small band of people as they venture back into the city, led by one woman who still has her sight. through their experiences, we see the chaos of a city where all social infrastructures have broken down and people do their best to survive in their new grim reality. our ability to respond to the social and economic disruption that may be caused by an outbreak of a serious infectious disease may be tested should the world experience another influenza pandemic. following an outbreak in of a highly pathogenic avian influenza caused by the h n virus, the world health organization noted in that 'the world has moved closer to a pandemic than at any time since '. more recently, dr margaret chan, director-general of the world health organization, has noted that 'for the first time in history, the world has been watching the conditions that might start an influenza pandemic unfold in real-time'. while human-to-human transmission of the virus has yet to be established, by june , there had been cases of human infection with the h n virus, including deaths, primarily in south east asian countries. the world health assembly has called on its member states to develop national preparedness plans, and the world health organization has provided recommendations and checklists for national plans. while many countries have taken steps to develop preparedness plans for an influenza pandemic, variations between countries and gaps in the plans are still evident. in the uk, a house of lords science and technology committee report noted that government figures estimated that illness-related absenteeism from work during a pandemic could cut gross domestic product (gdp) by £ - billion, while pandemicrelated excess mortality could cut gdp by an additional £ - billion ( . - . % mortality). in australia, the impact of pandemic influenza in the absence of an effective vaccine and if containment fails has been estimated at , - , deaths, , - , hospitalizations and - . million outpatient visits. at global level, 'even in one of the more conservative scenarios, it has been calculated that the world will face up to outpatient visits, . million hospital admissions and . million deaths globally, within a very short period'. the sudden and dramatic increase in demands upon the health system during a pandemic would challenge already-stretched health resources and personnel, highlighting the need for health systems to have in place plans for surge capacity to respond to disasters and health emergencies. in addition, absenteeism in the community more generally could challenge the continuity of critical infrastructures, such as power, telecommunications and water, upon which hospitals rely. while the social disruption arising from pandemic influenza would be considerably less than the total social breakdown portrayed in saramago's story, 'blindness' reminds us of the fragility of our current lives and the speed with which our worlds can be turned upside down. it reminds us of how selfish and uncaring people can be when they are scared and feel threatened, and how quickly order can descend into chaos. it also tells of the courage and strength of the human spirit when faced with danger. this paper talks about the role that law can play in providing some certainty for times of chaos. legal frameworks can clarify the rights and duties of individuals, communities and governments for times of crisis, and public discussions around these issues can themselves help to alleviate community anxiety. in thinking about the legal framework, there are two main issues to be addressed. first, there is a need for an understanding of the role of law in public health at state, national and international levels, and the need for jurisdictional clarity when differing levels of law and government intersect. these legal frameworks are important, for they define the scope of government responses to public health emergencies at local, national and international level. secondly, our understandings of the role of law in responding to pandemics are necessarily informed by relational bonds between individuals in society, and by the meanings of rights and responsibilities for public health laws when dealing with infectious disease. gostin has defined public health law as 'the study of the legal powers and duties of the state to assure the conditions for people to be healthy . and the limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals for the protection or promotion of community health'. reynolds points out that 'public health law is a disparate collection of laws and government responses, with its common feature a focus on the population rather than the individual'. while law plays an important part in shaping the role of state action and intervention in the health of individuals and communities, the scope of these state powers is shaped by a range of factors including: the nature and traditions of the legal system in the country in question; cultural understandings of the individual, the community and the state and of the relationships between them; and the wealth or poverty of the country and its people. as magnusson points out, in the context of liberal democracies, debates about the boundaries and meanings of public health law reflect 'competing claims about the boundaries for the legitimate exercise of political and administrative power'. our understandings of law and ethics, and indeed of health itself, are culturally and historically specific, requiring dialogue and cooperation for effective global responses to issues of common concern. the legal framework for public health in australia is made up of a mixture of federal and state legislation, with quarantine powers reserved to the federal government in the australian constitution, and the states having control over other public health matters. the reality is somewhat more complex than this suggests, as the federal government can achieve public health objectives through the use of its other constitutional powers, such as the grants power in section of the constitution which allows the federal government to make financial grants to the states, and the spending power in section which allows the federal government to fund health programs. , however, while the federal government can seek to use its other constitutional powers to achieve health-related objectives, it is important to realize that the power under section (ix) of the constitution to make laws 'with respect to quarantine' is the only power relating to communicable diseases directly given to the federal government in the constitution, and that this, in turn, shapes australian debates about government responses to public health issues and emergencies. while the absence of comprehensive health-related powers for the federal government in the constitution may seem surprising given our contemporary reliance on a national public health insurance system (medicare), and the general trend in australia away from federalism and towards centralization, it is important to remember that these are more contemporary features of the australian political landscape and were not in existence at the time of federation and the drafting of the constitution in the opening years of the th century. australia's geographic location and the fact that it is an island continent have influenced australia's historic approach to quarantine. maglen has argued that while england increasingly relied upon sanitary measures in the th century for protection against disease, quarantine remained an important tool against imported disease in the australian colonies of the time. new south wales introduced australia's first quarantine legislation with the quarantine act , and federal quarantine legislation was adopted in . australia's quarantine act (cth) sets out the powers and procedures for the administration of quarantine in australia. under the act, the scope of quarantine is quite broad and covers a range of measures which aim to prevent or control 'the introduction, establishment or spread of diseases or pests that will or could cause significant damage to human beings, animals, plants, other aspects of the environment or economic activities'. the act defines a quarantinable disease as 'any disease, declared by the governor-general, by proclamation to be a quarantinable disease'. masters of vessels are required to make a notification to a quarantine officer if prescribed symptoms or a prescribed disease is present on board, or if the master 'has reason to believe or suspect' that a quarantinable disease or pest is on board. individuals or vessels can be ordered into quarantine if they have a quarantinable or communicable disease, and there are also powers to subject individuals to quarantine surveillance in certain circumstances. the governor-general can declare, by proclamation, that an epidemic exists or that there is the danger of an epidemic, and while the proclamation exists the minister may give directions and take actions necessary to control, eradicate or remove the danger of the epidemic by way of quarantine or measures incidental to quarantine. , the quarantine act is focused on preventing quarantinable diseases at ports of entry into australia. while there is still benefit in this focus, it is inadequate for a world where international travel is now primarily by aircraft, and passengers can travel from one country to another before they even realize that they are sick. as a canadian report on severe acute respiratory syndrome (sars) noted, 'sars has illustrated that we are constantly a short flight away from serious epidemics'. while previous outbreaks of pandemic influenza have traditionally taken - months to spread globally, aided by international air travel, pandemic influenza could spread globally within months. this potential for quarantinable diseases to emerge within domestic populations raises questions about the scope and applicability of quarantine laws in these circumstances. however, it has been argued that the broad scope of quarantine under the act, the fact that quarantine powers are not restricted to ports of entry, and the ability for state laws to be over-ridden in emergencies suggests that the federal quarantine power could also have domestic application. domestically, state public health laws are also relevant to the notification and control of communicable diseases. in new south wales, for example, sars and avian influenza in humans are both notifiable diseases under the public health act . state public health laws also contain a range of measures to enable health authorities to restrict the spread of disease, including powers to require medical testing and, in some cases, powers to restrict movement or to specify treatment of individuals who are regarded as posing a risk to public health. a the intersections between federal and state laws are relevant to australia's responses to public health threats. as howse has noted, 'in a public health emergency caused by the spread of an emerging infectious disease, australia could need to rely on a patchwork of legislative measures to assist it to cope'. in australia and elsewhere, cross-jurisdictional and interagency cooperation are essential components in effective emergency responses. , at an international level, the international health regulations (ihr) provide a framework for notification and response to infectious diseases. first introduced in as the international sanitary regulations, and renamed in , the ihr required member states to notify the world health organization of cases of plague, cholera and yellow fever. prior to , smallpox was also on the list of notifiable diseases. however, the ihr became increasingly irrelevant during the th century with the re-emergence of old diseases such as tuberculosis, the emergence of new diseases such as sars, and the threat of biological weapons. , a revised version of the ihr was adopted in and took effect from . the ihr ( ) seek to balance public health responses to disease against the needs of international traffic and trade, and rest on the principle that public health responses should not unnecessarily interfere with international traffic and trade. while the ihr ( ) has a list of specified diseases, including sars and smallpox, which must be notified to the world health organization, the ihr ( ) also move beyond the specified-diseases approach and adopt a broader approach with focus on events which could constitute a public health emergency of international concern. using a decision algorithm, countries are required to assess public health events in order to determine whether the event is a public health emergency of international concern. if the event is of international significance, notification to the world health organization is required. the new ihr focus on risks to health, and provide a more flexible and relevant approach to identification of those risks. , the ihr ( ) focus on the development, strengthening and maintenance of capacities at national level to respond to public health emergencies of international concern. as outlined above, the legislative frameworks in australia for public health responses to infectious diseases are shaped by australia's federal legal system, and will also be relevant to the responses in other countries with a federal structure. in becoming a signatory to the ihr ( ), the usa submitted a reservation to the ihr on the basis of federalism, noting: 'the government of the united states of america reserves the right to assume obligations under these regulations in a manner consistent with its fundamental principles of federalism. with respect to obligations concerning the development, strengthening and maintenance of the core capacity requirements,.these regulations shall be implemented by the federal government or the state governments, as appropriate and in accordance with our constitution, to the extent that the implementation of these obligations comes under the legal jurisdiction of the federal government. to the extent that such obligations come under the legal jurisdiction of the state governments, the federal government shall bring such obligations with a favourable recommendation to the notice of the appropriate state authorities.' b in australia, the pandemic influenza planning process has taken a whole of government approach, with the planning process involving both federal and state levels of government. in , the national health security act (cth) was passed. part of the act deals with public health surveillance and has as its objects: provision of a national public health surveillance system to enhance the ability of commonwealth, states and territories in identifying and responding to 'public health events of national significance'; information sharing with the world health organization and 'countries affected by an event relating to public health or an overseas mass casualty'; and 'to support the commonwealth, and the states and territories in giving effect to the international health regulations'. in april , the commonwealth, state and territory governments signed the national health security agreement to support the national health security act and to ensure a coordinated approach between the different levels of government in the event of a public health event of national significance. in , the national pandemic influenza exercise, exercise cumpston enabled the testing and assessment of australia's pandemic preparedness through the use of a comprehensive simulation exercise. quarantine laws and public health laws do give governments some fairly broad powers to declare quarantine and to restrict the movement of individuals. there is a very real sense in which these powers may well be needed in order to ensure an effective public health response to pandemic influenza. however, these laws are also clearly situated within a broader social context. our perceptions of individual liberty and individual rights have undergone considerable evolution since most of our public health laws were originally introduced. today, the public is likely to have high expectations about the preservation of individual liberty and freedom of movement. these expectations underpin the political context for the development and application of public health laws in australia. appropriate responses to these expectations will also play an important role in addressing community unease and potential disobedience to the implementation of response measures. when seeking to clarify public health laws, it is important that we take this broader social context into account. as gostin notes in his definition of public health law outlined above, public health laws are not only about articulating the coercive powers of the state for enforcement of public health measures, but also about the limits of state power and the rights of individuals and communities. the language of human rights is increasingly part of the landscape for health law in australia and a see, for example, public health act (nsw) s . internationally. [ ] [ ] [ ] given the potential for public health laws to impact upon the freedom of individuals, and the need for public health laws to balance the interests of individuals and society, public health laws will ideally have a transparent ethical framework, articulating the principles upon which state intervention will be premised. the world health organization has acknowledged the importance of legal and ethical considerations to pandemic preparedness, noting that public health measures such as quarantine, compulsory vaccination and off-licence use of medicines 'need a legal framework to ensure transparent assessment and justification of the measures that are being considered, and to ensure coherence with international legislation (international health regulations)'. consideration of ethical issues is also essential for, as the world health organization has noted, ethical issues 'are part of the normative framework that is needed to assess the cultural acceptability of measures such as quarantine or selective vaccination of predefined risk groups'. the exercise of state powers in terms of quarantine, isolation and detention during a public health emergency is likely to be particularly controversial in western liberal democracies such as australia. the extent to which the state can and should exercise its powers in this area has become increasingly relevant in public health, as is clear from debates over detention of tuberculosis patients, , and from the use of quarantine during the sars crisis. although comparable countries to australia in europe, the usa and canada all have human rights charters or equivalents, which could provide procedural protections and safeguards for citizens in relation to quarantine and detention, australia has yet to develop a bill of rights at the federal level. while australian state and territory governments have begun enacting human rights legislation, there is no comprehensive inclusion of human rights safeguards in the federal quarantine act, which raises issues about the mechanisms for ensuring procedural safeguards in the event of a pandemic. public health measures directed at implementing social distancing, quarantine or travel restrictions will not only infringe on individual liberties that are often taken for granted in western societies, but are also likely to have a profound economic impact. as outlined above, estimates indicate that pandemic influenza will have a significant impact on the global economy. at local level, businesses may be closed or experience a reduction in their cash flow as public health measures are introduced or people stay home voluntarily. in such an environment, the economic cost to individuals and businesses may be significant, which in turn demands consideration of development of support systems and compensation systems for those affected. in the usa, a great deal of work has been done on strengthening the public health laws, both generally and specifically for public health emergencies. the turning point public health statute modernization national collaborative developed the turning point model state public health act. in , the centre for law and the public's health at georgetown and johns hopkins universities prepared a model state emergency health powers act, setting out the powers for a state of public health emergency. the provisions of the earlier model state emergency health powers act were adapted and included in the turning point model act. article v of the turning point model act deals with the powers of public health authorities, including the powers of quarantine and isolation. the model act provides that the principles to be applied in relation to quarantine and isolation include that they should be by the least restrictive means necessary to prevent the spread of disease (s - [b]( )). in addition, there is a provision that: 'the needs of individuals who are isolated or quarantined shall be addressed in a systematic and competent fashion, including but not limited to, providing adequate food, clothing, shelter, means of communication with those in isolation or quarantine and outside these settings, and competent medical care.' (s - [b]( )) article vi of the turning point model act deals with public health emergencies, and contains provisions addressing: planning for a public health emergency; declaring a state of public health emergency; management of property, safe disposal of infectious waste and human remains, and control of healthcare supplies; protection of individuals; immunity from private liability; and payment of just compensation for the use or appropriation of facilities or materials. the turning point model act is intended as a tool to enable governments to assess their existing public health laws. the turning point model act not only sets out the rights of the state in terms of its coercive powers, but also the responsibilities of the state to care for those who are isolated or quarantined. these matters are important if we are to see public health laws as a matrix of both rights and responsibilities. if individual autonomy is to be constrained in the name of public health, we also need to ensure that individual dignity, and ultimately social dignity, is maintained. non-pharmaceutical measures may have a significant community impact. consideration may need to be given to support mechanisms if voluntary, stay-at-home forms of quarantine or isolation are used to limit the spread of influenza in the community. there is also a need to consider the flow-on effects of some of our public health measures. if schools are closed, for example, this may have an immediate impact on the broader workforce in a context, such as the contemporary australian one, where significant numbers of women with children are in the paid workforce. rights and responsibilities are multilayered. they arise at local, national and global levels and at the intersections between these levels. what is clear is that public health rights and responsibilities for infectious disease are global as well as national. if we are to assess the adequacy of our legal frameworks for pandemic preparedness, we also need to assess the adequacy of our laws in terms of their suitability for meeting our international obligations. while developed countries of the world already have sophisticated public health systems, the capacity to meet their obligations under the ihr ( ), and the financial resources to develop national vaccine stockpiles, the developing countries of the world face a very different outlook. as we consider the intersections of law and public health in the context of the shared global risks of an influenza pandemic, it is important to realize that pandemic preparedness must necessarily involve improved international cooperation and the sharing of expertise to assist in capacity building for public health and the regulatory frameworks surrounding it, as well as a renewed dialogue around international obligations to help the world's poorest and least healthy people. legal analysis must be a key part of our planning for pandemic influenza. it is essential that federal and state laws are harmonized so as to ensure their smooth functioning and to eliminate crossjurisdictional differences and uncertainties. public health laws also play a key role in setting out the rights and responsibilities of individuals, communities and governments, providing transparency and accountability to the frameworks for decision-making. in contemporary australian society where there are high expectations of individual rights and freedoms, and of the public health system, public health laws have an important role to play in ensuring that, as far as is possible, the public's health and the public's freedom are both balanced and protected. effective preparedness for pandemics does not end at national borders. pandemic influenza will affect all parts of the globe, leaving no country untouched. as we prepare for the next influenza pandemic, we must remember that global cooperation is also an essential part of effective preparedness. none sought. none declared. avian influenza: assessing the 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cumpston report. canberra: australian government, department of health and ageing will international human rights subsume medical ethics? intersections in the unesco universal bioethics declaration health law's kaleidoscope: health law rights in a global age the proliferation of human rights in global health governance world health organization. ethical considerations in developing a public health response to pandemic influenza. geneva: world health organization world health organization. who checklist for influenza pandemic preparedness planning. geneva: world health organization world health organization. who checklist for influenza pandemic preparedness planning. geneva: world health organization detention and the evolving threat of tuberculosis: evidence, ethics and law through the quarantine looking glass: drugresistant tuberculosis, public health governance, law and ethics sars thrusts quarantine into the limelight for discussion, see williams g. the victorian charter of human rights and responsibilities: origins and scope times of pestilence: would a bill of rights assist australian citizens who are quarantined in the event of an avian influenza (bird flu) pandemic? pandemic and public health controls: toward an equitable compensation system public health statute modernization national excellence collaborative. turning point: collaborating for a new century in public health: model state public health act -a tool for assessing public health laws transforming public health law: the turning point model state public health act an exploration of conceptual and temporal fallacies in international health law and promotion of global public health preparedness the duty of states to assist other states in need: ethics, human rights and international law none declared. key: cord- -a svuwu authors: kavčič, tina; avsec, andreja; zager kocjan, gaja title: psychological functioning of slovene adults during the covid- pandemic: does resilience matter? date: - - journal: psychiatr q doi: . /s - - - sha: doc_id: cord_uid: a svuwu as a public health emergency, a pandemic increases susceptibility to unfavourable psychological outcomes. the aim of the present study was to investigate the buffering role of personal resilience in two aspects of psychological functioning, mental health and stress, among slovene adults at the beginning of the covid- outbreak. within five days after slovenia declared epidemics, participants ( % female) completed an on-line survey measuring mental health and perceived stress as outcome variables and demographics, health-related variables, and personal resilience as predictor variables. hierarchical logistic regression analyses demonstrated that women, younger, and less educated participants had higher odds for less favourable psychological functioning during the covid- outbreak. in addition, poorer health indicators and covid- infection concerns predicted diminished psychological functioning. the crucial factor promoting good psychological functioning during the covid- pandemics was resilience, additionally buffering against detrimental effects of demographic and health-related variables on mental health and perceived stress. while previous research suggests that mental health problems increase during pandemics, one way to prevent these problems and bolster psychological functioning is to build individuals’ resilience. the interventions should be targeted particularly at younger adults, women, less educated people, and individuals who subjectively perceive their health to be rather poor. a pandemic as a public health emergency in itself increases the proneness of people to various mental health problems, which may be further aggravated by the social distancing approach disrupting daily routines, restraining interpersonal communication and limiting the availability of social support [ , ] . while modern world has faced other epidemics and pandemics before, none of them had such world-wide and drastic effects on most of the individuals and their everyday life as the current covid- pandemic. the present study aimed to elucidate people's psychological functioning at the beginning of covid- outbreak. besides investigating the role of demographic characteristic and health-related variables in two aspects of individuals' psychological functioning -stress and mental health, special research interest was focused on examining the buffering role of personal resilience. on th of march the world health organization [ ] recognized the covid- as a pandemic. many countries, including slovenia, took increasingly stricter measures directed towards flattening the curve, i.e. slowing the infection rate of the virus across the population. these measures were primarily focused on social distancing and were to be continued for an unpredictable time. the present study was carried out during the first days of lockdown, characterized by significant changes in all aspects of people's daily lives and high overall worry about the infection, inflated by the exponentially increasing infection and death rates in the neighbouring regions of italy. studies carried out during previous recent outbreaks, such as the - sars epidemic [ ] , influenza a h n pandemic [ ] , - mers outbreaks [ ] , and the - ebola epidemic [ ] , suggested that such outbreaks are accompanied by significant psychological stress in healthcare workers and general population. increased mental health symptomatic seem to accompany the current covid- pandemic as well [ ] [ ] [ ] . among personal factors affecting psychological functioning during adversity, resilience has been suggested to have a buffering role in pandemic-related stress [ ] . the present study investigated resilience at the individual level as a personal quality that helps individuals to thrive in the face of adversity [ ] . the positive role of resilience in various stressful situations and life outcomes has been well-documented [ ] , but its effects on psychological functioning during virus outbreaks remains understudied with a few exceptions [ ] . the aim of the present study was to examine psychological functioning during the first days after the declaration of covid- pandemic. we aspired to broaden existing knowledge on psychological functioning during such public health crises by focusing not only on mental health problems (i.e. stress levels) but also on positive mental health, thus adopting the modern view of mental illness and mental health as separate though related entities [ , ] . moreover, we investigated the role of potential predictors of psychological functioning. in addition to more commonly explored role of demographic and health-related variables, including people's concern about covid- infection, this study also explored the incremental predictive value of individuals' personality resilience in the context of covid- pandemic. more precisely, resilience was expected to have a two-fold buffering effect: it could (i) inoculate individuals against elevated stress levels and decreased mental health, as well as (ii) weaken the negative impact of potential risk factors (e.g., pre-existing health conditions) on stress and mental health. the total sample consisted of participants with a mean age of . years (sd = . ). among them, . % were emerging adults ( - years), . % were early adults ( - years), . % were middle adults ( - years), and . % were late adults ( - years). a quarter of the participants ( . %) were male and three quarters ( . %) were female. regarding their education, . % had a high school or lower education and . % attained a post-secondary education or graduate degree. the data were collected within five days after slovenia declared epidemics. during these five days, the government closed all sales and service facilities (with the exception of food and pharmacy stores), schools and kindergartens, stopped public transportation, and prohibited public gatherings. furthermore, covid- claimed its first victim in slovenia. the data collection took place via an on-line survey platform. the link was distributed via social networks and advertised on the national radio and television's website. on the first page of the survey, the participants were informed about the aims of the study and asked to confirm their informed consent to participate. demographic data collected included information on sex, age, and educational level. the general health indicators included the presence of at least one chronic health condition (yes/no answer) and subjective reports of health, assessed along a continuous scale ranging from (very bad) to (very good). two contextualized health-related variables tapped the degree of worry regarding their own and their significant others' possible covid- infection, assessed on a continuous scale ranging from (not at all) to (very good). all continuous scale-scores were dichotomized with scores up to and including regarded as poor health/not worried and scores above as good health/worried. the item connor-davidson resilience scale -cd-risc- [ ] is a self-report scale that measures how well is one equipped to bounce back after adversity. each item is rated on a -point scale ( not true, true nearly all of the time). in the present study, the participants reported on their resilience for the past week. previous studies had shown good reliability, validity [ ] , and measurement invariance across age and sex [ ] for the cd-risc- . alpha reliability coefficient in our sample was . . the resilience score was dichotomized based on a median split (< vs. ≥ ). the perceived stress scale -pss [ ] is a self-report -item scale, designed to measure the degree to which situations in one's life are appraised as stressful. using a -point rating scale ( never, very often), participants specify how often did they feel or think in a certain way during the last week. the reliability and validity of the pss had been established as satisfactory [ ] . in our study, the alpha reliability coefficient was . . the perceived stress score was divided into the categories of low vs. high perceived stress based on a median split (< vs. ≥ ). the short form of the mental health continuum -mhc-sf [ ] consists of items that measure positive mental health. the overall score reflects emotional, psychological and social well-being. respondents rate the items on a -point scale ( never, every day during the past week). the mhc-sf has shown good internal consistency and sound validity [ ] . the alpha coefficient obtained with our sample was . . the presence of flourishing mental health is indicated when a person feels at least one of the three hedonic well-being symptoms "every day" or "almost every day" and at least six of the eleven psychological and social well-being symptoms "every day" or "almost every day" in the past week. the absence of flourishing mental health reflects moderate to poor well-being. demographic characteristics and descriptive statistics were examined for the entire sample and separately for those with flourishing vs. non-flourishing mental health and low vs. high perceived stress in the past week. overall, . % (n = ) participants were classified as having flourishing mental health in the past week and . % (n = ) participants perceived high levels of stress. more precisely, . % of the sample had favourable scores on both indicators of mental health and . % disadvantageous scores on both indicators, while . % reported low stress and low flourishing, and . % high stress and flourishing mental health. next, chi-square tests were performed to examine the association of independent variables with flourishing mental health and high perceived stress. generally, flourishing mental health was more common among men, older participants, and highly educated participants (table ) . flourishing was also more common among participants who reported having good health, had no chronic health conditions and were less worried about their own and other's potential infection with covid- . high stress was associated with female sex, younger age, lower educational level, lower subjective health and worrying about one's own and other's potential infection with the new coronavirus. finally, the strongest association was observed between high resilience and both indicators of good psychological functioning. hierarchical logistic regression modelling was employed to examine independent effects of demographic characteristics, health-related variables, and resilience on flourishing mental health and high perceived stress. in the first step, age, sex, and education were entered as covariates in the models. in the second step, self-rated health, chronic health conditions, and worry about one's own and other's potential covid- infection were added to the models. finally, resilience was entered in the models. except from age, all predictors were treated as categorical. the results of the first step of the hierarchical logistic regression models (table ) revealed that men, older, and more educated participants were more likely to have flourishing mental health during the previous week compared to women, younger, and less educated participants, who were instead more likely to report being highly stressed. both regression models were significant, but explained rather low shares of variance in the dependent variables (see nagelkerke r values in table ). adding health-related variables to the models as covariates revealed that participants who rated their health as poor, reported having chronic health condition(s), and were worried about their own and other's potential covid- infection were less likely to have flourishing mental health in the previous week, but more likely to report high perceived stress (with one exception the presence of chronic health conditions was not a significant predictor of high stress). the associations with sex, age, and education remained stable. again, both models were significant and some additional variance was explained in the two dependent variables. lastly, participants who were more resilient during the previous week had almost times higher odds of flourishing mental health and . times lower odds of high stress levels compared to those who were less resilient. this was by far the strongest predictor in both models. moreover, resilience attenuated the negative effects of female sex, lower education, and health-related variables on flourishing mental health. apart from poor self-rated health, these covariates no longer had significant negative effects. the attenuation effect of resilience was also observed when predicting high levels of stress, although it was weaker, with most of the predictors from previous steps remaining significant. the two final models were significant, with % and % of variance explained in flourishing mental health and high perceived stress, respectively. the present study investigated the buffering role of personal resilience in two aspects of psychological functioning, stress and mental health, during the outbreak of covid- and subsequent social lockdown, while taking into account individuals' demographic and healthrelated characteristics. the results obtained showed that demographic characteristics and health-related variables contribute significantly to favourable psychological functioning during the covid- pandemic, but their predictive value is rather weak and diminishes further once personal resilience is note. * p < . , ** p < . , *** p < . accounted for. nevertheless, younger age seems to represent a risk factor for poor psychological functioning during the pandemic, which is consistent with findings in china [ ] . this results could be seen as counterintuitive as the symptoms and consequences of the new coronavirus are worse for older as compared to younger adults [ ] . however, there is some evidence that flourishing is more common in middle and late adulthood than early and emerging adulthood [ ] , and the present study suggests that this holds true even in the face of such an adversity as the covid- pandemic. in addition, the present results suggest that women may be at a higher risk for nonflourishing mental health and high stress. while the statistics show somewhat higher covid- mortality rates for men than women [ ] , our results are in line with the notion that other consequences of the pandemic and lockdown, such as financial challenges, increased informal care of children and their schooling as well as sick family members, and decreased employment opportunities, could be more detrimental for women than men [ ] . this finding is also consistent with previous research showing somewhat higher susceptibility of women to elevated levels of stress and mental health problems than men [ ] . finally, in line with previous findings [ , ] , our results indicated a protective role of higher education in good psychological functioning, although this association was weak and diminished to the level of insignificance after controlling for personal resilience. our results further suggest that the subjective perception of one's health is more important for perceived stress and mental health during pandemic than objective health indicators, such as the presence of chronic health conditions. the later variable was included as the covid- mortality rates are higher for people with other medical conditions than those without [ ] . however, according to our results psychological functioning outcomes seem to be more contingent on subjective assessment than objective measures of health functioning. furthermore, high concerns about possible covid- infection also proved a significant predictor of high perceived stress and lower levels of mental health. nevertheless, the predictive value of subjective and objective health indicators and infection concerns diminished substantially once the resilience was taken into account. as our results show, the crucial factor of psychological functioning during covid- pandemic seems to be individual level resilience. even after taking into account demographic characteristics and health-related variables, presumed to be associated with risk of covid- infection and mortality, the probability of experiencing high stress and flourishing mental health during the current pandemic and lockdown depends mostly on the level of personal capability to cope with adversity and achieve good adjustment. the results thus support the hypothesized buffering role of resilience against diminished psychological functioning due to the covid- pandemic and associated preventive measures that may have concurrent and long-lasting negative effects on diverse aspects of people's everyday lives. furthermore, resilience was found to buffer against detrimental effects of various demographic and health-related variables on mental health as it noticeably attenuated their role in stress and particularly in mental health. these findings corroborate the conceptualization of resilience as a trait that protects individuals against the impact of adversity or traumatic events [ , ] , and extend them to the context of the covid- pandemic with its unprecedented scope and wide-spread corollaries. the good news concerning our findings is that resilience can be effectively enhanced and thereby the risk of poor psychological functioning due to the pandemic and its consequences can be reduced. two evidence-based intervention programs may be especially suitable in the pandemic context [ ] : ( ) folkman and greer's approach [ ] promotes problem-focused coping for controllable events, emotion-based coping for boosting support and reducing isolation, and meaning-based coping for persistent events; ( ) the psychological first aid approach [ ] facilitates resilience immediately after trauma. in addition, previous studies provided evidence on effectiveness of several psychological interventions for boosting resilience, for example mindfulness [ ] , resilience regimen [ ] , self-efficacy training [ ] , and cognitive behavioural therapy [ ] . the american psychological association [ ] advises that individuals themselves can advance their resilience by building their social relationships (e.g., by keeping in touch with friends, accepting and offering support), fostering physical and mental wellness (e.g., practicing mindfulness, taking care of one's body), finding purpose (e.g., by helping others, being proactive, setting and moving towards realistic goals), embracing healthy thoughts (e.g., keeping things in perspective, accepting change, staying optimistic) and seeking professional help when feeling unable to function well. certain limitations of the study should be highlighted. first, the study relied on selfreported questionnaire data, which are susceptible to various biases [ ] . however, stress and well-being are inherently subjective phenomena and thus may be best assessed by selfreports. second, the data collection took place on an online survey platform. even though % of slovenians, aged from to years, regularly use the internet [ ] , the method of data collection and study advertising may have led to self-selection of participants, especially in late adults as half of the slovenian adults, aged over years never use the internet at all [ ] . the older adults who did participate in our study are (compared to the non-participating older adults) probably more familiar with modern digital technology, which could be associated with better cognitive and social functioning [ ] , leading to better mental health and confounding possible age effects investigated in our study. also, our sample was not representative in terms of sex structure, with more females than males participating. third, the study presented had a correlational cross-sectional design precluding any causal interpretations. to overcome this drawback, we asked the participants to continue taking part in the study and the follow-up data collection is under way. the main message for the policy makers, media, educators etc. is that while mental health problems increase during pandemics, one way to prevent these problems and increase good psychological functioning is to build individuals' resilience by educating general public and healthcare workers on evidence-based effective strategies, organizing and promoting intervention programs, and taking measures in work (especially healthcare) organizations aimed at fostering resilience. the results of the present study suggest that the intervention providers should pay special attention to younger adults, women, less educated people and individuals who subjectively perceive their health to be rather poor. in addition, our results support that it is important to consider indicators of both good and poor psychological functioning, as low stress does not necessarily imply flourishing mental health and vice versa [ , ] , and the predictive associations were not the same for stress 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building in students: the role of academic self-efficacy strengths-based cognitive-behavioural therapy: a four-step model to build resilience building your resilience information bias in health research: definition, pitfalls, and adjustment methods usage of internet in households and by individuals the "online brain": how the internet may be changing our cognition publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.tina kavčič is an associative professor at faculty of health sciences, university of ljubljana, slovenia. she teaches courses on health psychology, personality psychology, psychology in healthcare and psychology in physiotherapy. her research interests are focused on personality development, factors of well-being, and social relationships in different developmental periods.andreja avsec is an associative professor at department of psychology, faculty of arts, university of ljubljana, slovenia. she teaches courses on personality psychology, individual differences, and positive psychology. her research interests are focused on personality traits and their outcomes, well-being, flow, and emotional intelligence.gaja zager kocjan is an assistant professor at department of psychology, faculty of arts, university of ljubljana, slovenia. she teaches courses on personality psychology, and psychology of emotions and motivation. her research interests are focused on measurement issues in psychology, personality change, flow, and mental health. key: cord- -mswb q authors: zumla, alimuddin; dar, osman; kock, richard; muturi, matthew; ntoumi, francine; kaleebu, pontiano; eusebio, macete; mfinanga, sayoki; bates, matthew; mwaba, peter; ansumana, rashid; khan, mishal; alagaili, abdulaziz n.; cotten, matthew; azhar, esam i.; maeurer, markus; ippolito, giuseppe; petersen, eskild title: taking forward a ‘one health’ approach for turning the tide against the middle east respiratory syndrome coronavirus and other zoonotic pathogens with epidemic potential date: - - journal: int j infect dis doi: . /j.ijid. . . sha: doc_id: cord_uid: mswb q the appearance of novel pathogens of humans with epidemic potential and high mortality rates have threatened global health security for centuries. over the past few decades new zoonotic infectious diseases of humans caused by pathogens arising from animal reservoirs have included west nile virus, yellow fever virus, ebola virus, nipah virus, lassa fever virus, hanta virus, dengue fever virus, rift valley fever virus, crimean-congo haemorrhagic fever virus, severe acute respiratory syndrome coronavirus, highly pathogenic avian influenza viruses, middle east respiratory syndrome coronavirus, and zika virus. the recent ebola virus disease epidemic in west africa and the ongoing zika virus outbreak in south america highlight the urgent need for local, regional and international public health systems to be be more coordinated and better prepared. the one health concept focuses on the relationship and interconnectedness between humans, animals and the environment, and recognizes that the health and wellbeing of humans is intimately connected to the health of animals and their environment (and vice versa). critical to the establishment of a one health platform is the creation of a multidisciplinary team with a range of expertise including public health officers, physicians, veterinarians, animal husbandry specialists, agriculturalists, ecologists, vector biologists, viral phylogeneticists, and researchers to co-operate, collaborate to learn more about zoonotic spread between animals, humans and the environment and to monitor, respond to and prevent major outbreaks. we discuss the unique opportunities for middle eastern and african stakeholders to take leadership in building equitable and effective partnerships with all stakeholders involved in human and health systems to take forward a ‘one health’ approach to control such zoonotic pathogens with epidemic potential. benefit the large majority of affected people. some foreign aid workers and researchers were not familiar with local cultural and medical services norms and aroused local anxieties. the evd epidemic highlighted the need for developing more comprehensive local, national, international, and global surveillance, as well as epidemic and outbreak preparedness response infrastructures. multiple animal, human, and environmental factors are obviously playing a critical role in the evolution, transmission, and pathogenesis of zoonotic pathogens, and these require urgent definition to enable appropriate interventions to be developed for optimal surveillance, detection, management, laboratory analysis, prevention, and control in both human and animal populations. an important need exists for establishing long-term, sustainable, trusting and meaningful and equitable collaborations between the animal, human, ecosystem, and environmental health sectors at the local, national, and international levels. these should include sustainable political and funder support for developing human and laboratory capacity and training that enables effective human-animal health cooperation leading to proactive surveillance, early detection of potential pandemic pathogens, and rapid initiation of public health prevention and control guidelines and interventions. whilst a long list of pathogens with epidemic potential are on the radar of the world health organization (who), ideally 'prevention is better than cure' and new pathogens should be dealt with at the animal source, tackling the drivers and triggers of pathogen evolution and emergence. this requires close cooperation between human and animal health systems and an appreciation of human impacts on the environment at all levels and easy access to adequate laboratory facilities. on december , an expert panel convened by who prioritized a list of emerging pathogens ''considered likely to cause severe outbreaks in the near future, and for which no, or insufficient, preventive and curative solutions exist''. , the list of the top includes the new viral zoonotic pathogen of humans mers-cov, , which was first isolated from a patient who died of a severe respiratory illness in a hospital in jeddah, saudi arabia in june . the emergence of mers-cov in was the second time (after sars-cov ) that a highly pathogenic coronavirus of humans emerged in the st century. a strong link between human cases of mers-cov and dromedary camels has been established through several studies. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] mers-cov is endemic in the camel populations of east africa and the middle east , , and presents a constant threat to human health in both regions. retrospective studies using stored serum from different geographical locations have indicated that mers-cov has been circulating for several decades. as of may , , there have been laboratoryconfirmed cases of mers reported to the who, with a mortality of % ( cases died). whilst most mers cases have been reported from the middle east (a large proportion from saudi arabia), mers cases have been reported from countries in all continents. the who has held nine meetings of the emergency committee (ec) for mers-cov. since evidence of sustained human-to-human transmission of mers-cov in the community is lacking, the who currently does not recommend travel restrictions to the middle east. however, mers-cov remains a major global public health threat with continuing reports of new human mers cases in saudi arabia, where millions of pilgrims from over countries travel throughout the year. furthermore, a more intensive farm-based camel livestock system has emerged and there is a large, wellestablished trade in camels between countries at the horn of africa and countries in the middle east. this has increased significantly, particularly following the lifting of the ban on live animal imports from somalia by saudi arabia in / . somalia now exports some five million live animals every year to the gulf arab states (including camels), making it the single biggest exporter of live animals in the world. the positive experience of reviving somalia's livestock export industry through increased investment in animal disease prevention and control strategies highlights how effective the 'one health' approach can be. most of the african countries do not have the resources, expertise, or capacity, including laboratory facilities, to have active surveillance for mers-cov in place. in light of this, the need for increased vigilance and watchful surveillance for mers-cov in sub-saharan africa has been highlighted previously. such an initiative could be supported through investments by countries that import large numbers of camels and other livestock from the region. the epidemic potential of mers-cov was recently illustrated by a large outbreak in hospitals in seoul, the republic korea, in mid- : mers-cov was imported by a traveller to the middle east (an agriculture businessman), resulting in mers cases with deaths. the first case was reported on may , and over the ensuing weeks, the number of secondary, tertiary, and perhaps quaternary cases of mers from this single patient rose rapidly, resulting in the largest mers case cluster occurring outside the middle east. the unprecedented outbreak was attributed to poor infection control measures at the hospitals. sequencing studies of the mers-cov isolate showed genetic recombination of mers-cov in the case exported from korea to china. however, recombination is a frequent event in mers-cov and the korean outbreak is unlikely to represent a special form of the virus. nonetheless, the potential evolution of mers-cov into a more virulent form needs to be monitored closely. research on sequencing seems to have stagnated and there have been no further sequences published from new human mers cases reported from the middle east. furthermore, the genetic evolution of mers-cov strains infecting humans over the past year remains unknown. there is an urgent need for more sequencing studies on mers-cov evolution in camels and humans, with the development of appropriate local capacity for these studies. the kingdom of saudi arabia has kept proactive watchful mers-cov surveillance with regular reports to the who of mers-cov cases. the who and ministries of health of middle eastern countries continue watchful surveillance of the mers-cov situation, and the watchful anticipation is that mers-cov may disappear with time like sars-cov. however, with the continuing, regular reports of community cases of mers-cov from saudi arabia, there are no signs of this happening in the near future and lessons must be learnt from the korean outbreak. whilst there is a growing camel livestock industry in the region, elimination of the virus is unlikely in the short term. several animal, human, and environmental factors are obviously playing a critical role in the repeated movement of mers-cov from camels to humans. the disease ecology remains largely unknown. urgent definition is required to enable appropriate interventions to be developed for optimal surveillance, laboratory detection, management, prevention, and control in both human and animal populations. whilst several ad hoc research studies have been conducted and findings published over the past years, more comprehensive investments in tackling mers-cov have not been forthcoming. there remain huge knowledge gaps on mers-cov. much of the information that we have about the source of mers-cov infections is based on small local studies and it is difficult to develop general country-wide policies without a clear understanding of the zoonotic problem. questions remain, for example are new local mers outbreaks in saudi arabia always seeded by the same type of human exposure to camels? are there particular regions of africa that provide infected camels to saudi arabia? or is there a general risk from all regions? is there a way to efficiently control the entry of infected camels? are animal vaccination strategies economically viable given the large number of imported animals and the frequency of the infection? a clear policy in which full virus genome sequences are generated from every outbreak in the country and in which virus from subsets of imported camels is routinely screened and sequenced after years, would provide incredibly useful information about the transmission patterns of the virus and how to stop it. certainly the resources and expertise to perform this sequence monitoring are available and only governmental support is needed to run such a survey. the cost of such a survey would be far less than the management costs and grief associated with a single hospital outbreak. numerous priority research questions regarding mers-cov (basic science, epidemiology, management, and development of new diagnostics, biomarkers, treatments, and vaccines) in both humans and camels, highlighted years ago by the who mers expert groups and by others, remain unanswered. these have again been raised recently, highlighted by calls from saudi arabian health care staff and scientists , and by yet another who mers expert group, which has defined a ''roadmap for research and product development against mers-cov''. in the who set up the global outbreak alert and response network (goarn) for better coordination of surveillance efforts across the globe. it networks institutions and partner agencies, with cooperation with other agencies such as public health england and the us centers for disease control and prevention (cdc) and consortia such as the international severe acute respiratory and emerging infection consortium (isaric). recent consortia such as glopid-r aim to bring together research funding organizations on a global scale to facilitate an effective research response within h of a significant outbreak of a new or re-emerging infectious disease with pandemic potential. the past years has seen outbreaks of ebola virus, zkv, and mers-cov, [ ] [ ] [ ] which indicate that the global community needs to seriously reflect on what is critically missing from current political, scientific, and public health agendas, and how to delineate what is required at the national, regional, and global levels to prevent future epidemics. the factors and operating conditions that promote the emergence and geographical spread of zoonoses are complex and may be related to a single event or chain of multiple events influenced by the genetic evolution of the pathogen, environmental and climate changes, anthropological and demographic changes, and movement and behaviour of humans, animals, and vectors. with animal, human, and environmental factors playing a critical role in its evolution, mers-cov requires more close collaboration between human and animal health systems and university academics to reduce the risk of pandemic spread. moreover, a better understanding of the agricultural dynamics involved in its persistence and spread in camels and studies on interactions between hosts in the environment are urgently needed. the intermittent detection and reporting of mers cases in the community and sporadic nosocomial mers-cov outbreaks will require a more coordinated response plan to study clinical cases, conduct translational basic science and clinical trials research, and perform longitudinal sequencing studies from human and camel mers-cov isolates. a more collaborative mers-cov response plan is required to better define mers-cov epidemiology, transmission dynamics, molecular evolution, laboratory capacity, optimal treatment and prevention measures, and development of vaccines for humans and camels. a better understanding of the prevailing disease ecology and investigations into the dynamics of infectious agents in wildlife could act as a better means of preventing outbreaks in livestock and people at source. the 'one health' concept is an important concept that focuses on the relationship and interconnections between humans, animals, and the environment, and recognizes that the health and wellbeing of humans is intimately linked to the health of animals and their environment (and vice versa). [ ] [ ] [ ] [ ] [ ] a balanced ecological approach improves understanding of the true threat of novel pathogens and helps to avoid costly, poor, and inappropriate responses to new diseases. in many cases, solutions can be found through altered development pathways and are not inevitably requiring of costly, unsustainable technical and pharmaceutical interventions. thus it is ideally suited to the mers-cov situation in which camels, humans, and environmental factors are central to its persistence and evolution. since the kingdom of saudi arabia is host to millions of pilgrims each year travelling from all continents, tackling the threat of mers and other infectious diseases with epidemic potential will require enhanced closer cooperation between those who provide human health, animal health, and environmental health services, locally, nationally, regionally, and internationally: the middle eastern, european, african, asian, and american governments, veterinary groups, the who, the food and agriculture organization (fao), the african union, the united nations international children's emergency fund (unicef), the world bank, office international des epizooties (oie), cdc, public health england, the newly formed africa cdc, and funding agencies among others. they should now demonstrate increased commitment towards local, national, and global multidisciplinary collaborative efforts to secure optimal health for people, animals, and the environment. global efforts need to be focused on establishing the capability for and strengthening of surveillance systems in developing countries, particularly in africa where emerging and re-emerging zoonoses are a recurrent problem. a prime emphasis should be on developing awareness and response capacity in all countries and on promoting interdisciplinary collaboration and coordination. critical to the establishment of a well-functioning 'one health' platform is the creation of a multidisciplinary team with a range of expertise, including public health officers, physicians, veterinarians, animal husbandry specialists, agriculturalists, ecologists, vector biologists, viral geneticists, and researchers, with easy access to adequate laboratory facilities, who will collaborate in order to learn more about zoonotic spread between animals, humans, and the environment and to monitor, respond to, and prevent major outbreaks. there is an urgent and critical need to build a sustainable public health programme and rapid response capability for outbreaks of zoonotic pathogens in the middle east and in low-income countries, especially in africa. importantly there is a need for capacity development programmes designed to strengthen research training and build career pathways for the best and brightest post-doctoral researchers, including phd and masters students working at the interface of humans, animals, and environment. these should include national or regional laboratory facilities, as surveillance requires laboratory support to be meaningful. the development of human and animal health research leaders will create a critical mass of local research capacity and the development of self-funding research environments in african universities and research institutes. this capacity growth could be facilitated through the further development and support of a geographical network of equitable and enduring south-south and north-south partnerships. . need for more effective political and scientific engagement to eradicate the threat of mers-cov and other zoonotic diseases the persistence of mers-cov years since its first discovery has created major opportunities for each of the middle eastern and african countries to take leadership of the 'one health' approach with a view to bringing this under regional and global umbrellas, to tackle new emerging and re-emerging infectious diseases with epidemic potential. this will also devolve current dominance of the global health agenda by western groups and consortia and allow equitable partnerships to be established with long-term sustainability. the past year has seen some progress in research into mers-cov, but there remains a need for a more effective, coordinated, and multidisciplinary 'one health' consortium to take forward mers-cov research on priority areas already defined by saudi scientists , and the who mers committee. the establishment of regional 'one health' centres of excellence in the middle east (under the league of arab states) and at specific geographical locations in west, central, east, and southern africa could make an important difference in mitigating the risks and factors that pose a risk to both human and animal health. furthermore, any operational plan developed will contribute to strengthening the sentinel surveillance systems in sub-saharan africa in the preparedness and response to potential outbreaks. regional centres should be sufficiently empowered to manage the spectrum of 'one health' approaches to zoonotic disease control in humans and animals, from behaviour change and social interventions for prevention to surveillance of infections and antimicrobial resistance, and preparedness and response to outbreaks. a model for the major syndromes (respiratory, neurological, haemorrhagic, gastro-enteric, and sepsis-like presentations) should be developed so that clinical protocols may be adapted rapidly for any major outbreak during mass gatherings. this should include the development and introduction of innovative and smart platforms for data sourcing, sample collection, and analysis, in order to give clinicians and public health workers continuously updated information on which clinical decisions may be based. there is a pressing need to develop and strengthen the national ethics and medicines regulatory frameworks in sub-saharan africa in order to strike a balance between the public health interest, the interests of the pharmaceutical industry, and ethical values. parallel initiatives across africa and the tropics could be harmonized to create regional networks that can serve as a repository for expert 'one health' advice on agriculture, sustainable livestock, and the links to human development. there are several ongoing important initiatives on developing 'rapid response' and broader 'one health' capacity development groups in europe, asia, and the americas to assist in the surveillance and response to emerging infectious disease threats. the public health systems of west african countries failed with the ebola epidemic, and the response from the who and the international community was very slow and uncoordinated. this led to thousands of people, including over health care workers, losing their lives. the factors governing the appearance and disappearance of new coronaviruses affecting humans are complex and it has been over years since the first patient died of mers-cov. mers cases continue to be reported throughout the year from the middle east. there is a large mers-cov camel reservoir and there is no specific treatment or vaccine. the precise pathway from infected camel to the recurring mers hospital outbreaks needs to be understood in order to devise effective control measures. with million people visiting saudi arabia every year for umrah and/or hajj and the increasing importation of live animals from sub-saharan africa, the potential risk of global spread will be everpresent, especially if mutations or recombinations in mers-cov occur. a major 'one health' initiative to tackle mers-cov at source in animal populations is thus required. middle eastern and african governments should now work more closely together and increase collaborative efforts with international partners and global public health authorities if we are to prevent yet another global zoonotic pandemic. conflict of interest: all authors have a specific interest in 'one health'. the authors declare no conflicts of interest. there was no financial support. emerging and 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research on the middle east respiratory syndrome coronavirus in riyadh, ksa knowledge gaps in therapeutic and non-therapeutic research on the middle east respiratory syndrome world health organization. a roadmap for research and product development against middle east respiratory syndrome-coronavirus (mers-cov) international severe acute respiratory and emerging infection consortium. the website for the international severe acute respiratory and emerging infection consortium (isaric) global research collaboration for infectious disease preparedness website emerging infectious diseases and pandemic potential: status quo and reducing risk of global spread development of medical countermeasures to middle east respiratory syndrome coronavirus what is one health? one health global network one health: a new professional imperative. one health initiative task force one world, one health. oie-world organisation for animal health sharing responsibilities and coordinating global activities to address health risks at the animal-human-ecosystems interfaces. a tripartite concept note international organization for standardization. who develops iso standards. geneva: who towards a one health approach to controlling zoonotic diseases key: cord- -c vfs q authors: allegranzi, benedetta; memish, ziad a.; donaldson, liam; pittet, didier title: religion and culture: potential undercurrents influencing hand hygiene promotion in health care date: - - journal: am j infect control doi: . /j.ajic. . . sha: doc_id: cord_uid: c vfs q background: health care–associated infections affect hundreds of millions of patients worldwide each year. the world health organization's (who) first global patient safety challenge, “clean care is safer care,” is tackling this major patient safety problem, with the promotion of hand hygiene in health care as the project's cornerstone. who guidelines on hand hygiene in healthcare have been prepared by a large group of international experts and are currently in a pilot-test phase to assess feasibility and acceptability in different health care settings worldwide. methods: an extensive literature search was conducted and experts and religious authorities were consulted to investigate religiocultural factors that may potentially influence hand hygiene promotion, offer possible solutions, and suggest areas for future research. results: religious faith and culture can strongly influence hand hygiene behavior in health care workers and potentially affect compliance with best practices. interesting data were retrieved on specific indications for hand cleansing according to the main religions worldwide, interpretation of hand gestures, the concept of “visibly dirty” hands, and the use of alcohol-based hand rubs and prohibition of alcohol use by some religions. conclusions: the impact of religious faith and cultural specificities must be taken into consideration when implementing a multimodal strategy to promote hand hygiene on a global scale. health care-associated infection is a major patient safety problem worldwide, affecting hundreds of millions of patients each year. hand hygiene is considered the leading measure to reduce the impact of health care-associated infections and prevent pathogen transmission in health care settings, , but compliance with hand hygiene measures remains poor overall. , the world health organization's (who) global patient safety challenge, ''clean care is safer care,'' a core component of the who's world alliance for patient safety, is dedicated to tackling the issue of health care-associated infection worldwide. , the central strategy for achieving the goals of the challenge focuses on the development of who guidelines on hand hygiene in health care and their implementation in a pilot-test phase. these guidelines consider new aspects of hand hygiene promotion, including behavioral and transcultural issues. within this framework, the present article reflects the findings of the who's task force on religious and cultural aspects of hand hygiene. the task force was created to explore the potential influence of transcultural and religious factors on attitudes toward hand hygiene practices among health care workers and to identify some possible solutions for integrating these into strategies for improving hand hygiene. research into religious and cultural factors influencing health care delivery has been conducted previously, but mostly in the field of mental health and in countries with a high influx of immigrants, where unicultural care is no longer appropriate. , in a recent world conference on tobacco use, the role of religion in determining health beliefs and behaviors was raised and deemed a potentially strong motivating factor to promote tobacco control interventions. a recent review has listed various potential positive effects of religion on health as shown by studies demonstrating its impact on disease morbidity and mortality, behavior, and lifestyle, as well as the capacity to cope with medical problems. beyond these particular examples, the complex association between religion and culture and health-particularly hand hygiene practices among health care workers-remains a lightly explored, speculative area. an exhaustive literature search of the us national library of medicine's pubmed database from january to october was conducted without language restrictions. the key search terms used were ''religion,'' ''culture,'' ''hand hygiene,'' ''hand washing,'' ''hygiene,'' ''alcohol-based hand rub,'' ''buddhism,'' ''christianity,'' ''hinduism,'' ''islam,'' ''judaism,'' ''orthodox christianity,'' and ''sikhism.'' bibliographies of retrieved articles were also hand-searched for additional studies. relevant books on culture and health were consulted as well. leaders from the most important religions affiliated with the world council of churches (a fellowship of churches associated in an ecumenical movement to promote christian unity) and the muslim world league (an islamic nongovernmental organization that promotes islamic unity) were individually consulted to gather knowledge regarding the importance of hygiene, hand hygiene, and alcohol prohibition within the precepts and holy texts of their faiths. a total of articles were retrieved through the medline search. many of the articles referred to ''culture'' in the microbiological sense and had to be eliminated, together with numerous articles restricted to mental health. of the remaining articles, only referred to cultural and/or religious aspects influencing health, in particular hygiene, hand hygiene practices, and alcohol prohibition according to the most important religions; these were retained for review. the literature review and consultation with religious leaders were performed by of the authors (b.a. and d.p.), who identified the relevant issues to be considered and then brought these to the attention of the task force members through a formal consensus process. the task force comprised experts in infection control and behavioral theories, as well as anthropologists and psychiatrists. they met in april and were consulted by e-mail and telephone in and to finalize the article after an additional literature search. of the vast number of religious faiths worldwide, only the most widely represented were considered in this study (fig ) . for this reason, this review cannot be considered exhaustive by any means. some ethnoreligious aspects, such as practices of local, tribal, animistic, or shamanistic religions, also were evaluated. based on the literature review and the consultation of religious authorities, the most important topics identified by the task force were the importance of hand hygiene in different religions, hand gestures in different religions and cultures, the interpretation of the concept of ''visibly dirty hands,'' and the use of alcohol-based hand rubs in the light of alcohol prohibition by some religions. according to behavioral theories, , hand cleansing patterns are most likely to be established in the first years of life. this imprinting subsequently affects the attitude toward hand cleansing throughout life, particularly ''inherent hand hygiene,'' which reflects the instinctive need to remove dirt from the skin. the attitude toward hand cleansing in more specific opportunities, called ''elective hand hygiene practice,'' more frequently corresponds to the indications for hand hygiene during health care delivery. , in some populations, both inherent and elective hand hygiene practices may be deeply influenced by cultural and religious factors, although establishing whether a strong inherent attitude toward hand hygiene directly determines an increased elective behavior has proven difficult. hand hygiene can be practiced for hygienic reasons, for ritualistic reasons during religious ceremonies, and for symbolic reasons in specific everyday life situations (table ) . islam, judaism, and sikhism have precise rules for handwashing specified in holy texts, and this practice punctuates several crucial times of the day. in the sikh culture, hand hygiene is not only a holy act, but also an essential element of daily life. islam places great emphasis on cleanliness in both its physical and spiritual aspects, and the qu'ran gives clear instructions as to how this should be carried out (table ) . , with the exception of the ritual sprinkling of holy water on hands before consecration of the bread and wine and the washing of hands after touching the holy oil (the latter in the catholic church), the christian faith does not include definite indications for hand cleansing. in general, the indications given by christ's example refer more to spiritual behavior, but the emphasis on this specific viewpoint does not imply that personal hygiene and body care are not important in the christian way of life. similarly, the buddhist faith has no specific indications regarding hand hygiene in daily life or during ritual occasions, apart from the hygienic act of washing hands after each meal. culture also may be an influential factor regardless of religious background. in certain african countries (eg, ghana and some other west african countries), hand hygiene is commonly practiced in specific situations of daily life according to ancient traditions; for instance, hands always must be washed before raising anything to one's lips. furthermore, it is customary to provide facilities for hand aspersion (a bowl of water with special leaves) outside the house door to welcome visitors and allow them to wash their face and hands before even inquiring of the purpose of their visit. unfortunately, the hypothesis that community behavior influences health care workers' professional behavior has been corroborated by only scanty scientific evidence. in particular, we found no data on the impact of religious norms on hand hygiene compliance in health care settings in which religion is very deep-seated. this topic merits further research from a global perspective to identify the most effective components of hand hygiene promotion in these communities. hand use and specific gestures are universal but have considerable significance in certain cultures. the most common popular belief regarding the hands in african, hindu, jewish, and muslim cultures is to consider the left hand ''unclean'' and reserved solely for ''hygienic'' reasons, with the right hand used for offering, receiving, eating, and gesticulating. in the sikh culture, as in mahayana and tibetan buddhism, a specific cultural meaning is given to the habit of folding the hands together as a form of greeting, in prayer, or as a mark of respect. studies have demonstrated the importance of the role of gestures in teaching and learning, and there is certainly a potential advantage to considering this in the teaching of hand hygiene, particularly in its representation in pictorial images for different cultures. , in multimodal strategies to promote hand hygiene, posters placed in key points in health care settings have proven to be very effective tools for reminding health care workers to cleanse their hands. , , efforts to consider specific hand uses and gestures according to local customs in visual posters, including education and promotion material, may help convey the intended message more effectively. this area also merits further research. both the centers for disease control and prevention and the recent who guidelines recommend that health care workers wash their hands with soap and water when visibly soiled. otherwise, rubbing the hands with an alcohol-based formulation is recommended as the preferred practice for all other hand hygiene indications during patient care, because it is faster, more effective, and better tolerated by the skin. but infection control practitioners find it difficult to precisely define the meaning of ''visibly dirty'' and to provide practical examples when teaching hand hygiene. from a transcultural perspective, finding a common understanding of this term is even more difficult; for example, a spot of blood or other proteinaceous material is more difficult to see on very dark skin. furthermore, in a hot and humid climate, the need to wash the hands with fresh water also may be driven by the feeling of sticky or humid skin. according to some religions, the concept of dirt is not strictly visual and reflects a wider meaning, referring to interior and exterior purity. , among some health care workers, such a perspective may lead to the perceived need to wash the hands with water when feeling ''impure'' and may be an obstacle to the use of alcohol-based hand rubs. the cultural issue of feeling cleaner after handwashing rather than after hand rubbing actually was raised recently during a widespread hand hygiene campaign in hong kong and may underlie the inability to sustain the excellent hand hygiene compliance attained during the recent severe acute respiratory syndrome (sars) pandemic (w.h. seto, personal communication). from a global perspective, the foregoing considerations underscore the importance of making every possible effort to consider the concept of ''visibly dirty'' in accordance with racial, cultural, and environmental factors, and to adapt it to local situations with appropriate strategies to promote hand hygiene. based on scientific evidence, the use of alcoholbased hand rubs is considered the gold standard for hand hygiene in health care. , , , , , for this purpose, who recommends specific alcohol-based formulations that take into account antimicrobial efficacy, local production, distribution, safety, and cost issues at a country level worldwide. in some religions, alcohol use is prohibited or considered an offense requiring a penance (sikhism) or is considered to cause mental impairment (hinduism, islam) ( table ) . nonetheless, in theory, those religions with an alcohol prohibition in everyday life demonstrate a pragmatic vision that allows acceptance of the most valuable approach in the perspective of optimal patient care delivery. despite this generally tolerant approach, however, the religious background still may influence some health care workers who are unwilling to use alcohol-based formulations due to either reluctance to come in contact with alcohol or concerns about alcohol ingestion, inhalation, or skin absorption. , even the designation of a product simply as an ''alcohol-based formulation'' could become an obstacle for the implementation of worldwide recommendations. islamic tradition poses the toughest challenge to alcohol use. alcohol is clearly defined as forbidden (haram) in islam, and some muslim health care workers may feel ambivalent about using alcohol-based hand rub formulations. but in fact the qu'ran permits the use of any substance that man can manufacture or develop to reduce illness or contribute to better health, including alcohol used as a medicinal agent. similarly, cocaine is allowed for use as a local anesthetic, but not as a recreational drug. to better understand muslim health care workers' attitudes toward alcohol-based hand cleansers in an islamic country, the study by ahmed et al conducted in the kingdom of saudi arabia is very instructive. interestingly, although saudi arabia is considered the historic epicenter of islam, no state policy or permission or fatwa (islamic religious edict) was sought for the approval of alcohol-based hand rubs. indeed, hand rub dispensers have been installed in numerous health care settings since . this experience demonstrates that alcohol-containing hand rub solutions are indeed finally acceptable to many muslim health care workers, even within an islamic kingdom legislated by sharia (islamic law), and this may encourage other muslims to reconsider their attitude (fig ) . one concern of health care workers regarding the use of hand rub formulations is the potential systemic diffusion of alcohol or its metabolites after skin absorption or airborne inhalation. only a few anecdotal and unproven cases of alcohol skin absorption leading to clinical symptoms have been reported in the literature. , in contrast, reliable studies on human volunteers clearly demonstrate that the quantity of alcohol absorbed after application is minimal and well below toxic levels for humans. [ ] [ ] [ ] [ ] in a study mimicking high-quantity, high-frequency use, the cutaneous absorption of alcohol-based hand rubs with different alcohol components (ethanol and isopropanol) was carefully monitored. whereas insignificant levels of ethanol were measured in the breath and serum of a minority of the participants, isopropanol was not detected. finally, alcohol smell on the skin may be an additional barrier to the use of hand rubs; further product development should be conducted to eliminate this smell from hand rub preparations. in addition to targeting areas for further research, some possible solutions to existing problems may be identified (table ) . for example, starting in childhood, the inherent nature of hand hygiene, which is strongly influenced by religious habits and norms in some populations, could be shaped in favor of an optimal elective behavior toward hand hygiene. indeed, some studies have demonstrated that it is possible to successfully educate children of school age to practice optimal hand hygiene to help prevent common pediatric community-acquired infections. [ ] [ ] [ ] when preparing such guidelines, international and local religious authorities should be consulted and their advice clearly reported. an example of this is the statement issued by the muslim scholars' board of the muslim world league at its th annual meeting in mecca, saudi arabia, in january : ''it is allowed to use medicines that contain alcohol in any percentage that may be necessary for manufacturing if it cannot be substituted. alcohol may be used as an external wound cleanser, to kill germs and in external creams and ointments.'' in hand hygiene promotion campaigns in health care settings in which religions prohibiting the use of alcohol are represented, educational strategies should include focus groups on this topic to allow health care workers to openly raise their concerns regarding the use of alcohol-based hand rubs, help them understand the scientific evidence underlying this recommendation, and identify possible solutions to overcome obstacles ( table ) . results of these discussions could be summarized in an information leaflet to be produced and distributed locally. it has been suggested that in settings in which the observance of related religious norms is very strict, the term ''alcohol'' be avoided in favor of the adjective ''antiseptic'' when describing hand rubs. but concealing the true nature of the product by using a nonspecific term may be construed by some as deceptive and considered unethical. further research is needed before any final recommendation along these lines can be made. finally, the opportunity to involve patients in a multimodal strategy to promote hand hygiene in health care should be carefully evaluated. despite its potential value, this intervention may be premature in settings in which religious proscriptions are taken literally; rather, it could be a later step, after the achievement of awareness and compliance among health care workers. religious faith has made many important contributions to the ethics of health care and has helped focus the attention of health care providers on both the physical and spiritual nature of humans. however, wellknown examples exist of health interventions in which a religious viewpoint had a critical impact on implementation or even interfered with it. , an awareness of commonly held religious and cultural beliefs is vital when attempting to apply innovative concepts of modern medicine and implementing good clinical practice in today's increasingly mobile, multicultural health care community. in response to the challenge of incorporating an understanding of religious and cultural beliefs into programs to promote hand hygiene compliance, our study has identified some of the implications of those beliefs, has offered some potential solutions in response, and has suggested some areas for future research. the global patient safety challenge guideline for hand hygiene in health care settings. recommendations of the healthcare infection control practices advisory committee and the hicpac/shea/apic/idsa hand hygiene task force. society for healthcare epidemiology of america/association for professionals in infection control/infectious diseases society of america hand hygiene and patient care: pursuing the semmelweis legacy perneger tv, and the members of the infection control program. compliance with handwashing in a teaching hospital hand hygiene among physicians: performance, beliefs, and perceptions patient safety: a global priority clean care is safer care: a worldwide priority world health organization. who guidelines on hand hygiene in health care (advanced draft) hand hygiene: simple and complex culturally sensitive care of the muslim patient religion-based tobacco control interventions: how should who proceed? religion and health: a review and critical analysis the annual megacensus of religions why healthcare workers don't wash their hands: a behavioral explanation behavioural considerations for hand hygiene practices: the basic building blocks muslim teaching gives rules for when hands must be washed maintaining cleanliness and protecting health as proclaimed by koran texts and hadiths of mohammed savs you need hands constructing shared understanding: the role of non-verbal input in learning contexts teachers' gestures facilitate students' learning: a lesson in symmetry effectiveness of a hospital-wide programme to improve compliance with hand hygiene culture, religion and patient care in a multi-ethnic society. london: age concern books culture, religion and patient care in a multi-ethnic society. london: age concern books use alcohol hand rubs between patients: they reduce the transmission of infection cost implications of successful hand hygiene promotion hand hygiene and the muslim healthcare worker topical absorption of isopropyl alcohol induced cardiac and neurologic deficits in an adult female with intact skin gait disturbance, confusion and coma in a -year-old blind woman dermal absorption of isopropyl alcohol from a commercial hand rub: implications for its use in hand decontamination alcohol-based hand sanitizer: can frequent use cause an elevated blood alcohol level? can alcohol-based hand-rub solutions cause you to lose your driver's license? comparative cutaneous absorption of various alcohols quantity of ethanol absorption after excessive hand disinfection using three commercially available hand rubs is minimal and below toxic levels for humans effect of hand sanitizer use on elementary school absenteeism effect of handwashing on child health: a randomized controlled trial a systematic review of the effectiveness of antimicrobial rinse-free hand sanitizers for prevention of illness-related absenteeism in elementary school children resolutions of the islamic fiqh council crusading for change key: cord- -cdthfl f authors: burkle, frederick m. title: declining public health protections within autocratic regimes: impact on global public health security, infectious disease outbreaks, epidemics, and pandemics date: - - journal: prehospital and disaster medicine doi: . /s x sha: doc_id: cord_uid: cdthfl f public health emergencies of international concern, in the form of infectious disease outbreaks, epidemics, and pandemics, represent an increasing risk to the worldʼs population. management requires coordinated responses, across many disciplines and nations, and the capacity to muster proper national and global public health education, infrastructure, and prevention measures. unfortunately, increasing numbers of nations are ruled by autocratic regimes which have characteristically failed to adopt investments in public health infrastructure, education, and prevention measures to keep pace with population growth and density. autocratic leaders have a direct impact on health security, a direct negative impact on health, and create adverse political and economic conditions that only complicate the crisis further. this is most evident in autocratic regimes where health protections have been seriously and purposely curtailed. all autocratic regimes define public health along economic and political imperatives that are similar across borders and cultures. autocratic regimes are seriously handicapped by sociopathic narcissistic leaders who are incapable of understanding the health consequences of infectious diseases or the impact on their population. a cross section of autocratic nations currently experiencing the impact of covid- (coronavirus disease ) are reviewed to demonstrate the manner where self-serving regimes fail to manage health crises and place the rest of the world at increasing risk. it is time to re-address the pre-sars (severe acute respiratory syndrome) global agendas calling for stronger strategic capacity, legal authority, support, and institutional status under world health organization (who) leadership granted by an international health regulations treaty. treaties remain the most successful means the world has in preventing, preparing for, and controlling epidemics in an increasingly globalized world. “honesty is worth a lot more than hope…” the economist, february , . infrastructure, prevention, and preparedness, yet these protections remain far from being globally understood, available, practiced uniformly, or free of political control. what is increasingly common since the last one-third of the th century is the thread of public health emergencies permeating, and often dominating, the consequences brought on by wars, conflicts, and large-scale disasters. few are aware that wartime public health crises cause more deaths than weapons. , consistently in war, the public health protective threshold is destroyed and not recovered or maintained. recovery is purposely ignored, resulting in increasing post-crisis mortality and morbidity indices that are characteristically ignored or denied, especially if they negatively impact political, ethnic, or religious groups whose views are contrary to the newly installed autocratic regime. ruger reminds us that authoritarian regimes suppress political competition and tend to have an interest in preventing human development, because improved health, education, and economic security mobilizes citizens to advocate for greater participation and more resources. public health protections are literally invisible to populations; they are often taken for granted and applauded as great successes serving as propaganda ploys in public speeches. although there has been scant investment in public health infrastructure and protections in all parts of the world, those countries suffer the most under autocratic regimes, especially where they have failed to keep pace with population growth and density. currently, both the urban and rural environment of the st century are being defined by deficient dwellings, aged and inadequate infrastructure, and insufficient capacity to respond to crises, especially in ensuring access to safe water, food, sanitation, and energy. public health surveillance, the "continuous, systematic collection, and analysis of health-related data serve as an early warning system for impending public health emergencies, but compliance differs remarkably from one country to another." , indeed, the direct and indirect mortality and morbidity resulting from these tragedies are the responsibility of the government in power, but are often the first to be ignored. ecological and environmental protections and preservations, such as the continuous surveillance mandated by the world health organization (who; geneva, switzerland) of wet markets in china that launched sars (severe acute respiratory syndrome) in , is an example of a critical monitor that was ended prematurely. only the reporting of three diseases (yellow fever, plague, and cholera) are currently binding under the international health regulations, and then some countries are unwilling to notify who fearing economic and political consequences. stable and unstable political systems the processes of political development, primarily as they apply to stable and unstable political systems and change, have always been dynamic, especially in crisis situations such as outbreaks of infectious diseases in less-developed countries. crisis situations test the stability of political systems in revealing ways, placing extraordinary demands on the political leadership and the existing public health structure and processes of the country. in the absence of early and effective preparedness, societies may experience social and economic disruption, threats to the continuity of essential services, reduced production, distribution difficulties, and shortages of essential commodities. the who emphasizes a "whole-ofsociety" approach that emphasizes significant roles not only for the health sector, but also by all other sectors, individuals, families, and communities, in mitigating the effects of a pandemic. developing such capacities is at the heart of preparing the whole of society for a pandemic. i assert that it is the loss of the whole of society's concept, thinking, and participation that is systematically destroyed in autocratic regimes that contributes to why these political systems fail. they fail when citizens have no defined ownership, channels of communication, or are allowed to participate in any aspect of the disaster cycle (prevention, preparedness, response, recovery, or rehabilitation). they fail when citizens are not allowed a voice in the implementation of acceptable policies when the political system ceases to be viewed as responsive by individuals and groups making demands on it, and by what is considered inappropriate political behavior. infectious disease outbreaks have the uncanny capacity to question the status quo, catalyze smoldering unrest, and most importantly, reveal population-based public health imperfections. the "whole of society" which depends on a form of collaborative governance, which complements public policy, disappears and is seen only as the dictate of one person. indeed, the negative influence on society, what i refer to a "societal mental health," is out of proportion to their representation in society. the democracy index, compiled by the united kingdom's economist intelligence unit (london, uk) and published annually in the economist, ranks countries according to political and civic freedom using five criteria: whether elections are free and fair, whether governments have checks and balances, whether citizens are included in politics, the level of support for the government, and whether people have freedom of expression. nations are divided into "full democracies, flawed democracies, hybrid regimes [which include those exhibiting regular electoral frauds], and authoritarian regimes" where "political pluralism has vanished or is extremely limited." the edition is considered as having the "worst average global score since the index was introduced in , driven primarily by regressions in latin america and sub-saharan africa. globally, this is the first time in the modern era where we have the fewest democracies. by ranking on how functional their political systems are, less than five percent of the world's population live in a "full democracy." fewer countries can claim free and fair elections, checks, balances, and participation in their governments. fewer nations offer freedom of expression or political participation in established political cultures. rapidly established and increasingly prosperous autocratic regimes, many first drawn in by populist claims that enticed the masses of working-class and poor, are now firmly established by an economy ruled by dictators and oligarchs with unfettered political influence. the united states is now categorized as a "flawed democracy," experiencing both undeniable presidential claims for more authoritarian rule, a population that increasingly claims loss of traditional liberties, and low esteem in which us voters hold their government, elected representatives, and political parties. characteristics of autocratic regime leadership autocratic leaders demonstrate personality and behavioral characteristics that are remarkably consistent across borders and cultures. in great part, this is due to a common fault line from their adolescent development which becomes arrested cognitively and emotionally. while they may, at first glance, seems smart, they are not bright or capable of attaining abstract reasoning. this type of reasoning is required to formulate theories and understand multiple meanings crucial for reasoning. it demands generalizations, ideas, the ability to identify the relationship between verbal and nonverbal ideas, and to understand the multiple meanings that underlie an event, statement, or object; an example often cited is: "the liberty bell is not just a piece of american history, but is a symbol of freedom." concrete thinkers misinterpret many concepts like this and are compelled to reinterpret them in their own concrete manner in political speeches and legislative decisions. abstract thinking refers to a cognitive concept involving higherorder, or complex thoughts. to be able to think in an abstract manner implies that one is able to draw conclusions or illustrate relationships among concepts in a manner beyond what is obvious. often the terms "abstract thought" and "concept formation" are used interchangeably. in the past, the term "fluid intelligence" has been used to refer to the ability to reason. the generation of concepts, or abstract ideas, indicates an ability to progress beyond concrete thinking. the concrete interpretation of a concept involves a focus on the salient, obvious characteristics. progressing beyond the tangible characteristics in order to conceptualize theoretical relationships between items or processes involves abstract thought. deeper meanings such as "freedom," "equality," "charity," "love," and "democracy" express ideas, concepts, or qualities that cannot be seen or experienced. they are considered only in the concrete sense as it applies to autocratic thinkers. the us constitution would not be understood in the manner it was originally written as it is an example of a document that requires abstract thought and is either not read, understood, or interpreted concretely by a leadership that is completely self-serving. concepts such as freedom and equal rights interpreted concretely become self-serving. studies demonstrate that "persons with different value preferences apply different neurobiological strategies when facing a decision" and can help explain the fixed values that decisions are made that are independent of an actual situation. this stubbornness of thought and action is reflected in shared personality disorders of autocratic despots. brain areas beyond those activated in actual moral dilemma situations were found to be involved. they are psychologically fixed, as illustrated by muammar gaddafi when he was being beaten to death by his own people, claiming up to the last minute: "but the people love me!" some of the well-known behaviors include cover-ups, exaggeration, and fabrication; fraud, omission, half-truth, perjury, and lies that come in various types, conveyed to exaggerate one's credentials or get the attention that reflects their universal narcissistic disposition and constant needs. in great part, these behaviors are witnessed between all despots of the world. despite the bad press lies get, and that many press agencies tally the daily lie numbers, most are ignored by political supporters in every country, particularly the ones that have spoken to avoid conflict, and as a show of collective support. operationalization of narcissism is "dispositional" which accompany a "grandiose sense of selfimportance, exhibitionism, entitlement, interpersonal exploitativeness, and a total lack of empathy." autocratic leaders: [r]etain all power, authority, and control, and reserve the right to make all decisions; distrust their subordinate's abilities, closely supervise and control people under them; rarely delegate or empower subordinates; adopt one-way communication, do not consult with subordinates or consider their opinions; create a system of rewards and punishments; use threats and punishments and evoke fear; rarely concern themselves with developmental activities; and take credit for all the accomplishments. in truth, once in positions of power, only the most emotionally healthy and resilient can avoid the slide into psychopathology. for those with some of the personality attributes of sociopathy or psychopathy, the descent into deeper pathology may be beyond their ability to resist. even their followers can become pathologically dependent. democracies characterized by individual freedom and liberty are rare. throughout history, autocratic governments and tyranny have been the rule. their lack of conscience and an inability to feel remorse are the underlying factors that are often viewed initially as charming, but soon reveal uncanny skills as master manipulators, skillful at lying and cheating. they have no capacity to feel guilt. despite an incidence rate of three percent to five percent within the general population, and % of prison populations, it sometimes seems that they already rule the most despotic and populated areas of the world. part ii: pandemic status of countries under autocratic rule as of february , , nations have who-confirmed cases of covid- (coronavirus disease ) outside china. the global surveillance covid- database centralizes all covid- cases reported from outside china and is maintained at the who headquarters in geneva. their data analysis is conducted daily to: "follow the transmission of the disease between countries; describe the characteristics of human-to-human transmission within clusters of cases; describe the characteristics of affected persons and their exposure history; and support the evaluation of public health measures implemented in response to the epidemic." this study focuses only on countries under autocratic rule and describes the current status of public health preparedness and current responses. this review includes all countries run by one person or party with absolute power. autocracy is a system of governance headed by a single ruler called an autocrat. decisions made by the autocrat are not subject to legal restraints and the autocrat exercised unlimited and undisputed power. as of , nations are ruled by a dictator or authoritarian regime. admittedly, democracy remains unsure in many countries, especially africa, where dictators rising to power are increasingly likely. the study adds that: "europe is home to one dictatorship, while three of them can be found in latin america and south america. there are eight dictatorships in asia, seven in the eurasian region of the world, and twelve span territory from the northern parts of africa to the middle east." china i cut my humanitarian teeth in china in the s and s when an unprecedented % of the population was suffering from poverty and malnutrition, one of the highest in the world. i was one of the few foreign physicians continually invited back under mao's repressive regime. this allowed me an unprecedented view of china's attempt to re-define what is the anthesis to the established global who requirements that guaranteed population-based public health protections. i taught basic public health management and reforms and helped establish emergency services to many hospitals. i was engaged in these activities while the government emphasized unprecedented industrial and economic development that contributed to rapid and "remarkable achievements" in the overall social and economic health of the population. the incidence of poverty in china in declined from % to % in , a reduction of slightly more than million people, primarily accomplished through targeting rapid industrialization and village-based poverty. it also caused "twists and turns on the development of china's public health" requirements, which lagged vastly behind industrialization. public health was never given the same priority and failed to catch up with changes that required timely updating and adjustment of services. while it took time to recognize that china was on a path to also politically and economically redefine public health protections, infrastructure, and development, warnings directed at china's new regional centers for disease control (cdc; beijing, china) fell on deaf ears. that same lack of coordination and collaboration remains evident today, placing china under a different microscope, one of greater scrutiny and judgment from the global community who sees their many poor health outcomes. many of these poor outcomes are especially related to air pollution in re-defining hazardous air by who standards as "acceptable," and prompting many in china and the world to ask "at what price?" in , there was water scarcity in two-thirds of china's cities, % had no sewage treatment facilities, the food security program was unsustainable, % of groundwater was polluted, and major rivers had their downstream microorganism ecology altered by chemicals and fertilizers dumped by industry and cities into the water. this resulted in new and re-emerging diseases. after identifying sars origin from a wet market civet source in august of , president xi's economic address, tied to security concerns, called for "full protection of people's health, stressing that public health should be given priority in the country's development strategy." an independent survey of the chinese citizenry two months later revealed that while the chinese public agreed with xi's need to promote china's more influential role in the world, they raised grave concerns about environmental safety, numerous high-profile scandals regarding unsafe medical and food products, and water and air pollution. china's story mirrors that of other developing countries in asia, the fastest-growing region in the world, in that government spending on public health is inadequate and not focused on those who need it the most. studies in - confirm that % of china's groundwater is contaminated; tap water is not safe due to water contamination by the continued dumping of toxic human and industrial waste, because oxygen levels have obliterated normal organisms in all major rivers and only algae continue to flourish. air quality remains "very unhealthy" and continues to have a major toll on public health, resulting in , to , premature deaths. , it remains unclear whether china will ever meet its air pollution goals, let alone participate in global climate commitments to reduce carbon emissions. no one in global public health was surprised to learn that once again a wet market animal, not suited for human consumption, was probably responsible for this year's covid- pandemic. however, chinese researchers now stress that the virus did not originate in the wet market, but was transferred from elsewhere, on december th and again on january th. transmission could have begun in early december or late november, admitting the world-wide spread could have been limited had the earlier alerts been implemented. after sars in , external pressure has also impacted on the development of china's public health. during the sars outbreak, the who directly told the chinese government in its mission report in april that "[t]here was an urgent need to improve surveillance and infection control" in the country. two years later, in a joint report issued by state development research center (beijing, china) and who, the chinese government officially admitted its health care system was failing, and it needed to improve its disease surveillance system at the local wet market levels if they were to be seen as a "responsible state." in december of , the first cases of covid- were diagnosed in wuhan, the capital of hubei province, and rapidly expanded. for two weeks, the existence of a novel rapidly expanding virus was known to president xi. unconscionably, china arrested, jailed, and punished physicians and journalists who defied government attempts to silence the truth of the virus. moreover, the government ceased to enforce the timely flow of crucial public health information, delaying both critical medical care, its obligations to the who, and the sacred paradigm of human interaction with a disease that collectively defines "freedom of speech." andrew price-smith put the same point succinctly post-sars, stating that "while the sars epidemic may have generated moderate institutional change at the domestic level, it resulted in only ephemeral change at the level of global governance." in other words, national sovereignty is still of paramount importance for the chinese leadership. because of its sensitivity to foreign interference into its internal affairs, the chinese government has not yet formally or officially endorsed the notion of "human security." while china has embraced multilateral cooperation in a wide array of global health issues, its engagement remains "state-centric." , the sars event not only exposed a fundamental shortcoming of china's public health surveillance system, as well as its singleminded pursuit of economic growth since the late s, but also forced china to realize that, in the era of globalization, public health is no longer a domestic, social issue that can be isolated from foreign-policy concern. having no tolerance in ceding its supreme authority, the central government has adopted a multifaceted attitude towards its civil society organizations. while beijing shows its willingness to cooperate with a wide array of actors inside china, it refuses to let its domestic nongovernmental organizations (ngos) and activists establish direct links with their counterparts overseas. , china was openly accused of a cover-up with sars, and few professionals are confident that anything has changed. chan maintains that while "it is still uncertain whether this sovereign concern will trump the provision of global public good for health. nevertheless, in a highly globalizing world, infectious diseases know no border. while china is seeking to adhere as much as possible to the underlying norms and rules of global institutions," reemphasizing that china after sars "perhaps [needs] to reframe health as a global public good that is available to each and every individual of the world, rather than merely as an issue of concern to nation-states." in a rare openness, rarely seen before, the normally secretive xi admitted at a meeting to coordinate the fight against the virus that china must learn from "obvious shortcomings exposed during its response." yet given the second-guessing that always surfaces in these tragedies, "it cannot be denied that the chinese government tried to control the narrative, another sign of irrational hubris, and as a result, the contagion was allowed to spread, contributing to equally irrational fear." a china researcher for human rights watch (new york usa) noted: "authorities are as equally, if not more, concerned with silencing criticism as with containing the spread of the coronavirus. : : : repeating a pattern seen in past public health emergencies." although less clumsy than with sars, the government kept all non-party groups that could have helped prevent the spread of the virus out of the loop. , china's religious groups who "reflect the country's decades-long revival and feeling among many chinese that faith-based groups provide an alternative to the corruption that has plagued the government" are being ignored. will this just be a temporary stay as it was post-sars, or is china capable of adopting, without conditions, the who public health requirements they have ignored to date? north korea, the most sealed-off country in the world, has literally shut down all borders and communications on covid- , denying, according to their propaganda channels, the existence of any cases or deaths. this is unusual as it sits between china and south korea, which have recorded the largest numbers of cases. researchers state it is "unlikely that north korea is free of covid- ." south korean media reported that kim jong un, the north korean leader, had an official executed for violating the quarantine after the official returned from a trip to china. this may or may not be true since such reports have proved dubious in the past. north korea press outlets claim that "not one novel coronavirus has emerged;" yet south korea's unification ministry (seoul, south korea), in charge of inter-korean relations, reported to the who that north korea had tested suspected cases of coronavirus and all came up negative. nevertheless, south korean media, relying on anonymous sources, report cases of covid- in north korea, some of them fatal, according to john linton, head of the international health care center at severance hospital in seoul: "through private sources, they're asking for disposable gowns, gloves, and hazmat suits, which are undoubtedly lacking," he says. "so something is going on, otherwise they wouldn't be asking for this." north korea relies on china for more than % of its trade. researchers admit that while health indicators have improved in the two decades since the country's s famine, during which hundreds of thousands of people starved to death, but there are still major problems. in the s, amnesty international (london, uk) detailed a crumbling health care system in north korea, a nation unable to feed its population, and, in violation of international law. north korea refused to cooperate with the international community to receive food. levels of malnutrition, maternal health, and tuberculosis (tb) are chronic problems, but a lack of accurate data on hiv/aids and hepatitis b present cause for alarm. health indicators have improved in the two decades since the country's s famine, but major problems still exist. whereas communicable diseases account for a large proportion of the disease burden, there are very few opportunities to better understand and control them. while health infrastructure has improved, capacity is low and the health system is chronically under-resourced. north korea has allowed for united nation (un) interventions, primarily focused on sustainable development, but this has been on north korea's terms, a demand not unusual for autocratic regimes. in , the report of the un commission of inquiry on human rights in the democratic people's republic of korea (dprk) concluded that: " years after humanitarian agencies began their work in the dprk, humanitarian workers still face unacceptable constraints impeding their access to populations in dire need." the report found that the dprk has "imposed movement and contact restrictions on humanitarian actors that unduly impede their access." the dprk has "deliberately failed to provide aid organizations with access to reliable data, which, if provided, would have greatly enhanced the effectiveness of the humanitarian response and saved many lives." the north korean government "continually obstructed effective monitoring of humanitarian assistance, presumably to hide the diversion of some of the aid to the military, elite, or other favored groups, as well as to markets." in summary, the report stated: in this tightly controlled political climate, international humanitarian staff often have to make compromises. some point out privately that it is unrealistic to try to uphold humanitarian standards in an environment as difficult as north korea's. they try hard to come up with ways to make their aid sustainable for the north korean people, but their plans are not always accepted. although the knowledge of public health has improved in recent years, million people are dependent on a public distribution system of food rations and more than million are undernourished. , iran early in the coivid- crisis, iran introduced containment measures that china had instituted placing tens of millions of people under lockdown. yet, iran has confirmed infections and eight deaths, and appears to have entered the epidemic phase of the disease. pakistan and turkey announced the closure of land crossings with iran, while afghanistan said it was suspending travel to the country. four new covid- cases surfaced in tehran, seven in the holy city of qom, two in gilan, and one each in markazi and tonekabon. as of this writing, several reports from the cities in the south, west, center, and north of iran indicate cases testing positive for covid- . the iranian minister of health stated that the origin of the virus was in qom, where infected chinese nationals and iranians who traveled to china during its pandemic were diagnosed. reports suggest that a minimum number of cases is between , to , , with additional unofficial reports of deaths from hamedan, saveh, tonekabon, and tehran, suggesting that the government under-reports the number of positive cases. the health ministry ordered the closure of schools, universities, and cultural centers across provinces. all sport and cultural events were shut down for two weeks and all educational public exams were postponed. unfortunately, many health workers and physicians are among newly infected cases, including the deputy health minister. the country suffers a lack of basic equipment such as masks and disinfecting materials, even in health care centers. people are in a panic due to a lack of access to protective materials and angry over the government cover-up. , personal contacts in iran, unfortunately, report that: "there is a major concern of misinformation because people do not trust the governmental information, opening the doors for rumors and more misinformation." paul hunter, professor of medicine at britain's university of east anglia (norwich, england), said the situation in iran has "major implications" for the middle east. "it is unlikely that iran will have the resources and facilities to adequately identify cases and adequately manage them if case numbers are large." as of this writing, turkey has not reported any covid- infections. the government has closed its border with iran, introduced health checks from iran, and are turning back travelers. yet travel from turkey to iran continues. turkey is strategic in its geographic position. it is bordered by eight countries, is the intersection point of asia, europe, and africa, making it one of the most strategic countries in the world. with its geopolitical position, turkey is a unique bridge between eastern and western civilizations and between all religions. , i bring up turkey because that nation also has one of the most autocratic regimes in the world, which has mastered control over the population and media. the government has a pattern of undercutting critic's claims, accusing the opposition of having ulterior motives, and systematically undercutting the independence of the rule of law. recep tayyip erdogan's one-man rule-control all executive, legislative, and judicial functions by imprisoning critical journalists and destroying what was left of the free media. he has arrested teachers, police, and government workers. erdogan must be in control of the narrative on all issues, including health. after the lessoned learned in china with one non-medical voice controlling all news on covid- , a similar false narrative, seen with all dictators, may again occur. health differences with their northern european union (eu) neighbors were a concern that delayed accession talks for full membership in the eu in . one-half the population is made up of secular and liberal turks who wish to restrain erdogan and his abuse of power. african nations autocratic or authoritarian regimes-dictatorships-have been a dominant form of governance in africa for many years. in the second decade of the st century, one concern is that they may hinder the attainment of one of the un's crucial sustainable development goals. in the last three years, analysts say that african countries have registered an overall decline in the quality of political participation and rule of law. the british broadcasting corporation (bbc; london, uk) recently reported that "more and more elections are being held in africa." however, analysts dismiss many as being "lawful but illegitimate." although studies show a majority of africans still want to live in democracies, an increasing number are looking to alternative, autocratic models. african countries, in the last three years, have registered an overall decline in the quality of political participation and rule of law; analysts say: "today there are almost the same number of defective democracies ( ) as there are hardline autocracies ( ) , among the continent's states," nic cheeseman, professor of democracy at birmingham university (birmingham, england), concludes from his analysis of the last three years. nigeria is among those listed as a "defective democracy," which underscores the importance of recognizing fragile political parties in africa. recent elections in nigeria illustrates this. nigeria is seen as an emerging democracy often found in newly emerging states, and established democratic regimes existing in states with long traditions of uninterrupted sovereignty. most critically, many autocratic african countries have been thrown into an inescapable political mix with china because of china's close economic ties with multiple african countries. this economic dependence on china has grown so fast that it has critical future implications. the rapidity in which china has launched its massive continent-wide initiatives has been lost on many. the covid- pandemic has awakened scholars to revisit its impact on africa, where the world's most powerful autocratic regimes exist. as of , the african continent was home to more than . million chinese immigrants. from to , china's africa strategy began to solve overpopulation, pollution, and the poor economy in africa and other developing countries. china offered sizeable loans to finance infrastructure projects, which incurred major debts for many third world nations, but especially africa. these loans have changed the cultural and ethnic landscape of many struggling nations. the building of african ports, highways, and railways, all with chinese money, have primarily corporate-level intentions, not the daily welfare of the populations. on the surface, these sound infrastructure projects are what africa legitimately sees as necessary for progressing out of poverty. but on closer examination, they serve china's ambitions to write the rules of the next stage of what they define as "globalization." of major concern is that these african countries are now defaulting on the loans, primarily funded by countries other than china, for daily external assistance and survival. the very predictable failures of the african countries to pay back the loans have entrapped african nations even further: "china, as the only major creditor in africa, won't be far away from taking hold of virtually every industry in africa." according to the agreements set up by china, the african nations can repay loans with natural resources such as oil. yet, the defaulted loans made for constructing ports that were not productive are already owned by china. china's massive "belt & raid initiative" was designed to link up to countries, all tied to china's multiple infrastructure contracts and investments. overland routes for roads and rail transportation guarantee that most countries involved will never be able to fully pay the loans and will remain dependent on china for their trade economies in the coming years. this receives very little attention in the western press. in , forbes reported that china now owns international port holdings in greece, myanmar, israel, djibouti, morocco, spain, italy, belgium, cote d'ivoire, egypt, and about a dozen other countries. in , china took control of kenya's largest port after that nation defaulted on its unpaid chinese loans. china wants everything from africa-its strategic location, its rare earth metals, and its fish. this leaves african nations forever indebted to beijing. over one million chinese now work in africa, with one author citing that africa is "china's second continent," but the actual long-term impact of these many transient workers on african's future is mixed. one author summarized that "on closer examination, china's ambition is to write the rules of the next stage of globalization. this suggests that beijing will not accept anything less than being the dominant landlord, one that is autocratic and mimicking the current authoritarian regime in china. china wants africa's resources and its maritime roads for beijing's large military presence." this is evident from the fact that chinese troops and weapons outnumber all other countries, especially the us, which is decreasing its military footprint. china formally launched its first overseas military base in djibouti, where it constructed strategic ports, an electric railway, logistics, and intelligence facilities. but in all their projects, they focus on highways, ports, dams, and public networks, such as electric grids, not public health infrastructure. military might is their priority, a model taken from the us over the past two decades. while the us today is trimming down its military presence in africa, china is increasing theirs. from the outset, china and heads of state from african countries met to implement eight major initiatives to strengthen the cooperation between china and africa. some of the initiatives included industrial, trade, and cultural promotion, with public health ranking as a top priority for the china-africa health cooperation plans. in , there were , health professionals from china working in all african countries, focusing on public health training and disease-control programs centered on emerging infectious diseases, malaria, hiv/aids, and health informatics, in collaboration with africa cdc (addis ababa, ethiopia), us cdc (atlanta, georgia usa), and other global partners. what remains a contradiction is the strong health priorities of the china-african cooperation, which emphasizes many health initiatives that mainland china currently lacks. but china looks to the future and its survival. as they say in their next phase of "globalization," african economic dominance will be necessary for africa's survival. what political regime will rule at that time is questionable, but will probably be autocratic across china, africa, and other countries that currently face a potential military takeover by china, such as cambodia and myanmar. in the meantime, who and other regional and country public health experts are concerned the "fragile" health systems in most african countries will not be able to cope if coronavirus takes hold on the continent. even china, with its larger pool of technical and financial resources, appears to be struggling to contain the virus. , russia for all the advances in weaponry, including the first hypersonic missile, the poor-quality of public health directly "undermines the country's economic development." their aging population and declining birth rates contribute to the low overall health status and low life expectancy. more than two million russian men are considered to be hiv positive and extremely high multi-drug resistant tb persists. the direct connection between the public health crisis and russia's economic potential is clear. it is generally accepted that the highly productive educated soviets leave the country largely for reasons having to do with the deteriorating political freedoms in the country. failure to tackle russia's huge public health problems is likely to exacerbate the brain drain already underway. it is estimated that up to , more than . million russians emigrated. that represents an even greater number than those who left after the collapse of the soviet union. , russia reported its first two cases of covid- and said the infected people were chinese citizens who have since recovered. the first three russian citizens have also been infected with covid- onboard a quarantined cruise ship in japan. around , people arriving from china have been ordered/placed under quarantine for covid- and monitored by the russian capital's facial-recognition technology. their quarantine measures have mimicked other nations and appear robust, but remain challenging to the economy and sustainability. the one achilles heel in russia's public health is the abominable rise of infectious diseases such as tb and aids. public measures for their control in russia are insufficient, mainly because of the lack of funding for treatment, vaccine prophylaxis, and health education. tuberculosis has become an epidemic in a country where it was once a rarity. immunity is down because of poverty, too little food, and difficult access to health care. russian doctors are worried that the tb epidemic could lead to epidemics of another disease. today, tb is endemic in russia, and there is a rising incidence of multi-drug-resistant strains of tb. like other autocratic regimes, russia's "political model" of globalization that feeds transnational research and treatment of infectious diseases is seriously flawed and must take responsibility for the prevention of the spread of infectious disease beyond their borders accelerated by enhanced migration. what this reveals are cautious doubts about whether russia, combined with shortages of medical supplies and inadequate standards that further highlights a number of public health challenges for the country, has the public health and political capacity to manage a serious covid- epidemic. the borgen project, which addresses poverty and hunger, focuses on the leaders of the most powerful nations addressing the need to deal with poverty as a consequence of their dictatorial rule. it is repeated here as it serves as an objective measure of the consequences of a despotic rule, as well as an indication of the physical and emotional state of populations that might not survive the additional insult of an infectious disease: the united states, now designated a "flawed democracy," is showing increasing authoritarian rule and threats to basic health protections, especially in combatting communicable diseases. most concerning is the president's embrace of authoritarian leaders and the real possibility of major pandemic prevention funding, including the emergency reserve fund, which is designed to be "quickly deployed to respond to pandemic outbreaks." president trump has mimicked other autocratic leaders' positions in managing any serious outbreak. he has praised president xi's rulings and failed to comment on the chinese ruler's decision to punish physicians for grossly delaying international warnings and calling attention to the public health threat for which xi was totally responsible. trump's narcissistic personality will force him to be defensive and again lie to save face. peter navarro, trump's senior trade advisor, is quoted: "this delay allowed the virus to proliferate much faster than it otherwise would have and reach other countries that it might otherwise have not." trump does not possess the knowledge base or intellectual capacity to be the spokesperson for any north american outbreak. most critically, trump has set up a narrative that will impair the us's ability to manage any serious outbreak. he has argued for cutting spending for the cdc, national institutes of health (nih; bethesda, maryland usa), and medicare directly related to communicable diseases and will directly hinder any public health response. he is oblivious to the current status of emergency medicine departments in all hospitals, rural and urban, which are currently overloaded and have no beds for influenza patients. patients must remain in emergency rooms until critical care beds open somewhere in the system, and that may take days. in no manner is our current health system capable of handling a serious outbreak, and the failure to begin a dialogue with practicing medical professionals is being ignored. lipsitch predicts that some %- % of the world's population will be infected this year. despite political claims, a vaccine is more likely seen within a year or two at best. it is no longer realistic to expect the management of these gaps in infectious disease outbreaks, especially those that threaten to be epidemics and pandemics, are to be capably managed in their present state of willful denial and offenses by many countries, especially those that are ruled by authoritarian regimes. despite resistance to globalization's health benefits that would markedly benefit the global community during these crises by authoritarian regimes, in , i called for a new who leadership granted by the international health regulations treaty that has consequences if violated. i stated: the intent of a legally binding treaty to improve the capacity of all countries to detect, assess, notify, and respond to public health threats are being ignored. while there is a current rush to admonish globalization in favor of populism, epidemic and pandemics deserve better than decisions being made by incapable autocrats. during ebola, a rush by the global health security agenda partners to fill critical gaps in administrative and operational areas was crucial in the short term, but questions remain as to the real priorities of the global leadership as time elapses and critical gaps in public health protections and infrastructure take precedence over the economic and security needs of the developed world. the response from the global outbreak alert and response network and foreign medical teams to ebola proved indispensable to global health security, but both deserve stronger strategic capacity support and institutional status under the who leadership granted by the [international health regulations] treaty. treaties are the most successful means the world has in preventing, preparing for, and controlling epidemics in an increasingly globalized world. other options are not sustainable. given the gravity of on-going failed treaty management, the slow and incomplete process of reform, the magnitude and complexity of infectious disease outbreaks, and the rising severity of public health emergencies, a recommitment must be made to complete and restore the original mandates as a collaborative and coordinated global network responsibility, not one left to the actions of individual countries. the bottom line is that the global community can no longer tolerate an ineffectual and passive international response system. as such, this treaty has the potential to become one of the most effective treaties for crisis response and risk reduction world-wide. practitioners and health decision-makers world-wide must break their silence and advocate for a stronger treaty and a return of who authority. health practitioners and health decision-makers world-wide must break their silence and advocate for a stronger treaty and a return of who's undisputed global authority. will china's unilateral decisions just be a temporary stay as it was post-sars, or is china capable of adopting, without conditions, the who public health requirements they have so far ignored? autocratic leaders in history have a direct impact on health security. dictatorships, with direct knowledge of the negative impact on health, create adverse political and economic conditions that only complicate the problem further. this is more evident in autocratic regimes where health protections have been seriously and purposely curtailed. this summary acknowledges that autocratic regimes are seriously handicapped by sociopathic narcissistic leaders who are incapable of understanding the health consequences of infectious diseases or their impact on their population. they will universally accelerate defenses indigenous to their personality traits when faced with contrary facts, double down against or deny accurate science to the contrary, delay timely precautions, and fail to meet health expectations required of nations under existing international health regulations, laws, and epidemic control surveillance. kavanaugh's lancet editorial initially praised chinese tactics that reflected a level of control only available to authoritarian regimes. as days and weeks passed, it revealed a government that inherently became victims of their own propaganda based on "need to avoid sharing bad news." he concluded that authoritarian politics inhibited an effective response, and that openness and competitive politics favor a strategically fair public health strategy. democratic nations in comparison to autocratic regimes recognize that public health fundamentally depends on public trust. the who's china joint mission on coronavirus disease report has applauded china's eventual response capability and capacity with strict measures to interrupt or minimize transmission chains with extremely proactive surveillance, rapid diagnosis, isolation tracking, quarantine, and population acceptance of these measures, to implement the measures to contain covid- within the country. it must not be forgotten that china's authoritarian rule "put secrecy and order ahead of openly confronting the growing crisis and risking alarm or political embarrassment," arrested and compelled dr. li wenliang to sign a statement that his warning constituted "illegal behavior," all of which delayed a concerted public health offensive that led to his death. this was an "issue of inaction" that would have contained covid- within china and remains a potent symbol of china's failures. there is no evidence that the authoritarian regime has or will change to prevent this from happening again. i suspect china's sophisticated censorship and propaganda systems will outlast any public health improvements. world health organization research priorities in emergency preparedness and response for public health systems: a letter report wartime public health crises cause more deaths than weapons, so why don't we pay more attention? new security beat civilian mortality after the invasion of iraq interference, intimidation, and measuring mortality in war democracy and health democracy matters for health care report on global surveillance of epidemic prone infectious diseases: types of surveillance roles and responsibilities in preparedness and response development and change in political systems whole of society and whole of government approach. health and healthcare in transition: dilemmas of governance the economist intelligence unit the most authoritarian regimes in the world. business insider these are the best democracies in the world: and the us barely makes the list character disorders among autocratic world leaders and the impact on health security, human rights, and humanitarian care antisocial personality disorder and pathological narcissism in prolonged conflicts and wars of the st century comparing governments ( a): american government encyclopedia of aging and public health what is the point of equality? moral concepts set decision strategies to abstract values the profile of narcissistic dispositions: development and validation a critique of the autocratic leadership style. bright hub project management: resource management sociopaths: statistics: the nature of a sociopath covid- ) situation report- . world health organization dictatorship countries china poverty reduction. the world bank the development and reform of public health in china from to beijing smog prompts new concerns. borgen magazine china's deadly water problem. comment/opinion. south china morning post chinese public sees more powerful role in world, names us as top threat china's top environmental concerns. live science seeing through the smog: understanding the limits of chinese air pollution reporting. feature article. china environment series wuhan seafood market may not be source of novel virus spreading globally research: virus did not originate at wuhan market china's engagement with global health diplomacy: was sars a watershed the sars epidemic and its aftermath in china: a political perspective disappearing the coronavirus truth tellers sars was a watershed for china public health domestically but not globally negotiating and navigating global health: case studies in global health diplomacy the guardian weekly. staff and agencies. china is accused of sars cover up coronavirus "rumor" crackdown continues with censorship, detentions. china digital times another citizen journalist covering the coronavirus has gone missing in wuhan the coronavirus outbreak exposes the truth about socialism with chinese characteristics religious groups in china step into the coronavirus crisis. the new york times north korea claims zero coronavirus cases, but experts are skeptical north korea isn't ready for coronavirus devastation the crumbling sate of health care in north korea humanitarian engagement with north korea sanctions hurt but are not the main impediment to humanitarian operations in north korea public health in democratic people's republic of korea why is iran's reported mortality rate for coronavirus higher than in other countries? nbo news now coronavirus: iran's deputy health minister tests positive as outbreak worsens world is approaching coronavirus tipping point, experts say. the guardian xi says china facing "big test" with virus, global impact spreads healthcare in overview of turkey how dictatorships take root in the st century a comparative analysis of the european union's and turkey's health status: how health-care services might affect turkey's accession to the eu is africa going backwards on democracy? bbc news june is now democracy day in nigeria. why it matters chinese immigration to africa: an essay countries jumped tenfold in the last five years what china wants from africa? everything how large chinese loans are entrapping african nations china's seaport shopping spree: what china is winning by one million chinese in africa perspectives china says it will increase its military presence in africa public health priorities for china-africa cooperation africa prepares for coronavirus some african countries at risk for the new coronavirus aren't prepared. the verge: science/health public health challenges facing russia today cripple its potential for tomorrow. the globalist: rethinking globalization the sickness of a nation. the yale global health review coronavirus in russia: the latest news. the moscow times top diseases in russia current dictators as of . the borgen project the coronavirus outbreak could bring out the worst in trump. virology isn't politics harvard scientist: coronavirus pandemic likely will infect %- % of world this year johns hopkins bloomberg school of public health usa: the international bank for reconstruction and development/the world bank global health security demands a strong international health regulations treaty and leadership from a highly resourced world health organization theme papers on global public health and international law authoritarianism, outbreaks, and information politics china's harsh response to the coronavirus has influential admirers, but western nations recognize that public health fundamentally depends on public trust report of the who-china joint mission on coronavirus disease as new coronavirus spread, china's old habits delayed fight. the new york times coronavirus weakens china's powerful propaganda machine. the new york times key: cord- -nqukwoqz authors: al-mohaithef, mohammed; javed, nargis begum; elkhalifa, ahmed me; tahash, mohammed; chandramohan, sriram; hazazi, ahmed; elhadi, fatima elsheikh mohammed title: evaluation of public health education and workforce needs in the kingdom of saudi arabia date: - - journal: j epidemiol glob health doi: . /jegh.k. . sha: doc_id: cord_uid: nqukwoqz background: an efficient public health workforce is necessary for improving and maintaining the health of population and such a workforce can be prepared through proper educational programs and trainings. objectives: the present study aims to investigate the needs in the public health education programs, as well as need and availability of competent public health workforce in labour market of saudi arabia. methods: a descriptive, cross-sectional survey was administered in two phases in the college of health sciences at the saudi electronic university (seu). the first phase was carried out between september and december , which involved interview with administrative heads of four health-related organizations. the second phase was performed in september and june after starting an undergraduate course in public health at the university. a total of faculty and students from different branches of seu participated in the online survey. results: according to administrative head of public health-related organization, there is a shortage of qualified workforce in public health. all the four organizations need workforce with the master degree in sub-speciality epidemiology. about . % students agreed there is a shortage of public health speciality in these organizations. about . % faculty had an opinion that there is a requirement to set-up educational programs in public health. to overcome the shortage of competent workforce, two organizations showed interest in updating their employees’ skill through bridging courses. the students perceiving bachelor course in public health showed interest to accomplish master’s degree in epidemiology ( . %), public health education and promotion ( . %) and infection control ( . %). conclusion: there is a shortage of expertise in the public health organizations and there is a need for development of more public health schools in the kingdom of saudi arabia. the establishment of public health courses especially in the field of epidemiology at undergraduate and graduate level will help in the development of efficient and competent public health workforce. 'health human resources' is defined by the world health organization (who) as 'all people engaged in actions whose primary intent is to enhance health' [ ] . this includes all people who contribute to a functional health system: those who provide health care directly and those (like public health professionals) who address the underlying health determinants, and others who support the overall effort in other ways [ ] . efficient public health services are key in minimizing diseases and increasing the standard of living. public health is both multidisciplinary and interdisciplinary, as professional from different disciplines contribute their knowledge and skills for improving health [ ] . there is a strong linkage between the health workforce and public health education as public health require intellectually rich and challenging workforce [ ] . the initiative in public health traces back to , when american public health association was formed. the first independent school of public health (sph) began in in the united states (us) [ ] . the school was funded privately major by the rockfeller philanthropies, which in early th century helped to define public health profession [ , ] . the london school of hygiene and tropical medicine, the first sph in the united kingdom (uk) was founded in with support of rockfeller philanthropies [ ] . however, for much of the th century, there was no concept of organized public health. in , the hill-rhodes bill helped to renew interest in the public health in us [ ] . at this time there was evolution in teaching methods also, with greater emphasis to problem-based learning especially in medical schools [ ] . in , the american association of colleges and universities surveyed their membership and found that institutions offered undergraduate majors, minors or concentrations in public health in us [ ] . frenk et al. [ ] in estimated that there are about schools of public health worldwide irrespective of departments and courses. according to european association of schools of public health, over institutions in european region qualify as sph [ ] . in , uk had universities offering postgraduate qualification in public health [ ] , universities offering masters in different disciplines of public health such as nutrition, policy, the environment, research, management, nursing or communicable disease prevention [ ] , and the universities' central application service shows more than degrees that have a public health component [ ] . in the kingdom of saudi arabia (ksa), a royal decree from king abdulaziz established the first public health department in mecca in , for providing free healthcare to the population and hajj pilgrims [ ] . the monitoring of healthcare services were done through series of hospitals and dispensaries. the second milestone achieved in the public health service in ksa was establishment of ministry of health (moh) in under another decree. the moh responsibility was to manage, plan health policies, supervise and monitor health services in private sector [ ] . in ksa until s, the main objective of moh was to provide treatment for existing health problems for which expatriates were hired [ , ] . however, after the who general assembly in , in accordance to alma-ata declaration, the saudi moh began to develop preventive health service by adopting primary health care (phc) as one of its key health strategies [ ] . the phc focused on eight elements which included health education to prevent and control diseases, supply of safe water and basic sanitation, promotion of food supply and appropriate nutrition, maternal and child healthcare, immunization of children against major communicable diseases, appropriate treatment and providing of essential drugs [ ] . in saudi arabia, pilgrims from over countries gather to perform hajj every year and in this period the risk of public health problems related to infectious diseases increase [ , ] . the saudi government has taken a number of steps to improve the management of public health during hajj but still outbreaks occur [ ] . in there was a pandemic h n influenza, the data analyses from europe and the usa regarding the transmission dynamics of the virus estimated the basic reproduction number (r ) of the virus to be . - . , with higher estimates in japan r . ; ( % ci: . - . ) and in new zealand r . ; ( % ci: . - . ) [ ] . the saudi government was concerned that pilgrims suffering with or at risk of h n influenza could result in increased basic reproduction number and secondary attack rates of h n influenza during hajj. therefore, the saudi government collaborated with who to plan strategies to control the h n influenza pandemic from spreading during the hajj season [ ] . according to saudi ministry of education (moe) annual report [ ] , only ( . %) out of universities provide bachelor courses in different disciplines of public health and five universities ( . %) offers master's degree in public health. among the private universities and colleges, only four ( . %) institutions provide bachelor course in public health and one ( . %) offers a master's degree in public health. however, since public health education shows an approximate increase of % and % in bachelor courses in public and private institutions respectively. the progress rate shows that it would take a long time to fulfil the need of competent public health workforce of the country. although some government and private institutions are offering courses related to public health in ksa, there continues to be challenges in producing competent public health professionals. one challenge is the lack of a standardized public health curriculum offered in all universities and educational institutions in the ksa. this is achievable through accreditation of educational institutions, which will lead to promote common standards in the course and training programs required for preparing competent public health workforce. another challenge is to provide an appropriate and suitable practical exposure to the students so that they are able to justify the current trend of diseases [ ] . currently saudi arabia is experiencing outbreak of novel corona virus middle east respiratory syndrome (mers) caused by merscoronavirus (mers-cov) along with epidemiological and demographical transition, highlighting the importance of public health service and need of a competent public health workforce [ , ] . moreover, the large size of the country and scattered population poses challenges to the health care service delivery, which include health facility planning and distribution of workforce. as public health is associated with the prevention and control of the diseases, it requires the local workforce for effective and efficient administration and management of public health programs. the government is working on strengthening the health care system, through eight elements of phc approach. 'vision ' is a long term plans in the ksa for strengthening the public sectors in the country that includes health, education, infrastructure, recreation and tourism thereby improving the economy of the country. the coordination between public health educational institutions and public health service organizations would help to achieve vision goal of developing a sustainable public healthcare service in the ksa. the ksa is facing outbreak of several infectious diseases and going through an epidemiological and demographical transition so there is a need for competent public health work force. only few studies are conducted related to public health education and workforce needs in which most of the studies are not comprehensive and would be prejudiced to generalize the results. so a comprehensive study was designed, using a mixed method tools to assess the existing public health courses in the country and to investigate the needs in the public health education programs to strengthen the current courses. further, the study focuses on the need and availability of competent public health workforce to overcome the new challenges. in this descriptive cross-sectional research study, an exploratory mixed-method approach (qualitative and quantitative tools) was used to obtain information about public health education and workforce needs. data were collected and analysed sequentially. the design begins with collection and analysis of qualitative data in the first phase, in order to develop strength, weakness, opportunities and threats (swot) model to identify the existing gaps in capacities. based on the exploratory result from the first phase, the researchers conducted the second quantitative phase. a baseline data on existing educational institutions that offer public health education in the ksa was obtained from moe website and university website. as the study took long time to complete, the details of the educational institutions providing public health education was reviewed using annual report prepared by moe to update the data collected at the baseline. the data was collected through two phases. it was conducted between september and december . a face-to-face semi-structured interviews and meetings with the heads of four national public health administrations were carried out. all these heads belonged to different organizations were interviewed to perceive the paucity and needs of the organizations. the organizations were selected conveniently, and the interview focused on the qualifications held by the current employees of the organization, organization demands regarding qualifications and sub-specialty of public health and their perspective to support training programs for current employees. the different health organization administrative head selected for interview were ministry of municipal and rural affairs, saudi food and drug authority, ministry of environment, water and agriculture, and moh. it was done in september and june among faculty members and students of college of health science, seu. the study participants for the second phase were selected from different university branches in five major cities across saudi arabia. a random sample (n = ) students and (n = ) faculty members were contacted to participate in the study. however, students ( . % response rate) and faculty members ( % response rate) returned the survey with complete response. an electronic capture of survey data is an efficient tool to collect information from large number of study participants. the results obtained from the thematic analysis of first phase of the study provided the base for preparing the questionnaire for the collection of quantitative data in the second phase. a web-based questionnaire was designed to gather the students and faculty member responses in this phase. the faculty member questionnaire included six questions related to demographics (table ) and four close-ended questions related to need of public health educational programs in saudi arabia, their knowledge on the types of public health programs offered, and challenges in implementing these programs in other institutions (table ) . similarly, a structured questionnaire survey was done among students after enrolling in an undergraduate course in public health at the seu to gather their opinions about public health education and workforce needs. all students were included except who refuse to participate in the study. the questionnaire contained six questions related to demographic profile (table ); five close-ended questions related to information about public health speciality and source of information, where public health specialists work, shortage in sub-specialty of public health, sub-specialty of their preference and if the participant was a staff member of a healthcare organization, whether they receive support from their organization for completing their educational studies. the last question was an open-end question about whether there is a need for public health specialty in the moh and other public health organizations (table ). the study protocol was reviewed and approved by deanship of scientific research at seu. an informed consent was obtained from all study participants, and they were instructed to participate or withdraw from the study at any stage voluntarily. anonymized data were used for analysis and interpretation. data was analysed descriptively using the statistical software program ibm statistical package for the social sciences (spss) version (chicago inc., usa). the qualitative data obtained from the interview of administrative heads was used to develop swot model to identify the existing gaps in capacities, developing core messages needed; and estimated the capacity building needs for a comprehensive public health workforce program in the ksa. descriptive statistics (frequencies and percentages) were used to describe the main features of quantitative data and chi-square test was used to assess the association between the demographic variables of students and their responses. p-value < . was considered statistically significant. other health related specialties can perform the tasks of a public health professional . there is no needs for public health graduates in the saudi labor market . the qualitative data obtained in first phase from the administrative head of public health organizations, showed that the employees presently possess an associate degree or bachelor degree in disciplines not related to public health (table ) . moreover, it also found a shortage of competent workforce and a need of employees with bachelor ( %) or master degrees ( %) in public health. the quantitative data obtained in second phase showed student perceptions of . % agreement with the need of public health specialty in the public health organizations (table ). according to . % faculty member, there is a need to set up educational program in public health in the ksa (table ). the qualitative data obtained in first phase showed that all the four public health organizations ( %) had demand for employees with epidemiology as sub-specialty. the other sub-specialty, which ( ) update their knowledge, and skills through bridging course in the specialty of public health to attain competency ( table ). the quantitative data obtained in second phase showed the faculty member's perspective about public health courses with sub-specialty needed to be set up in educational institutions to create competent workforce in public health were epidemiology ( . %), environmental health ( . %), public health education and promotion ( . %), food safety ( . %) and infection control ( . %) should ( table ) . the students showed interest in perceiving the public health in sub-specialty epidemiology ( . %), public health education and promotion ( . %) and infection control ( . %) and this finding shows availability of competent workforce in future (table ). in swot analysis, the main strength of the organizations related to public health was found to be the willingness and commitment of ministries and other stakeholders to develop public health workforce programs. the weaknesses of the organizations found were shortage of resources and capacity to carry out public health workforce programs. the main opportunity for the organizations are the availability of global public health agency for partnership, but the lack of long-term commitment from the partner is the threat associated with it ( figure ). health authorities and specialists were the main response for source of information among male students ( %) than female students ( . %) (p = . ). the male students had more knowledge about the different work areas of public health specialist as . % of male students responded for other work area than the four main area of work compared with . % female students (p = . ). a significantly higher percentage of male students ( %) preferred to pursue sub-specialty environmental or occupational health as compared with . % female students (p = . ) ( table ) . no significant association was found in the responses of students pursuing bachelor degree and master degree for all the variables (p > . ) ( table ) . the association between student employment status and their response revealed that the majority of employed students ( . %) source of information was health authorities and specialist as compared with . % among unemployed students (p = . ). moreover, friends and family members as source of information was significantly higher among the unemployed students ( . %) compared with . % among employed students (p = . ) ( table ) . a significantly higher percentage of employed students ( . %) responded that there is a need of public health specialty for development of new public health professionals than unemployed students ( . %) (p < . ). the employed students had more knowledge about the different work areas of public health specialist as . % of employed students responded for other work area than the four main area of work compared with . % unemployed students (p = . ) ( table ). food safety, health surveillance, nutrition and community health were more preferred as sub-specialty by the unemployed students ( . %) than by the employed students (p = . ) ( table ) . are in demand in these organizations are food safety ( %), public health general track ( %), infection control ( %) and environmental health ( %) ( table ). the quantitative data obtained in second phase showed the student's perception about three subspecialties in high demand as epidemiology ( . %), infection control ( . %) and public health education and promotion ( . %). the sub-specialty public health general track, food safety and environmental health, which are in demand in public health-related organizations, received lesser response from students . %, % and . % respectively (table ). the qualitative data obtained in first phase put forward that administrative heads of public health organizations are planning to restrict the new recruitment to public health specialty to overcome competent workforce shortage. two organizations ( %) showed interest in supporting their existing experienced workforce to the present study results showed that the health workers in saudi arabia health organizations have an associate degree or a bachelor degree in other than public health as qualifications. this reflects the lack of appropriate qualifications, skills and experience to deal with challenges that arise in the public health field. a movement toward defining criteria for professional competence has evolved recently because it was a common practice in the past to recruit or promote an individual within public health agencies based on outdated concepts of professional qualification eligibility, seniority or sometimes due to the political interference without paying attention to the adequacy of their knowledge, attitudes and skills in public health [ ] . in the present study, all the public health-related organizations ( %) reported a need of specialized health workers with a qualification of at least master degree in public health sub-speciality epidemiology. this assessment of the educational needs of local public health organizations is an important step toward development of appropriate programs at the academic level to improve core competencies for public health professionals. most of the western countries demand master of public health degree, or its equivalent that is master of science in public health or master of health sciences, as professional entry-level qualification for public health [ ] . master of science in public health is programmed with emphasize to develop academically thought-provoking, student-centered learning, problem-solving and acquisition of skill necessary to practice public health. therefore, recruitment of highly qualified employees and focus on continuing education for updating recent development will be sufficient for valuable and competent work [ ] . the public health college and medical colleges must work together in an integrated model. this will help to generate the best possible healthcare workforce, develop innovative tools and approaches through research and eventually achieve the maximum potential for improving the public health. public health in the middle eastern countries is facing challenges both at the recruitment and retention of appropriate skills and expertise, in terms of both quality and quantity [ ] . the present study found the same opinions from the administrative heads of the various health organizations. there is an overarching need to improve the ways to address health determinants; which requires cadres of professionals appropriately trained in public health measures [ ] . the knowledge obtained from the swot analysis about the strengths and the opportunities can be utilized by the organization to develop the required workforce in public health-related departments. moreover, the knowledge about the weaknesses will help the organization to improve the competency level of the workforce and the threats associated with the organization will guide the organization to prepare for adverse conditions in advance. as per saudi moe annual report , < % government universities are providing bachelor courses in public health and < % is providing master course [ ] . the government of ksa is working hard on strengthening the health care system, through eight elements of phc approach. to achieve vision goal of developing a sustainable public healthcare services in the ksa, more public and private educational institutions should develop public health courses at undergraduate and graduate level, so that competent public healthcare workforce is produced. the sub-specialty on high demand by organizations was epidemiology. as the ksa is at its initial phase of developing public health services, emphasis is placed on the need for epidemiological skills. the workforce with specialty in epidemiology have skills to enable priority settings, service planning and evaluation of outcomes, have ability to develop and implement health improvement programs, surveillance of non-communicable disease and competent in proving advice on arrange of public health issues to local organizations and the public [ ] . at present, only three government universities and one private university is providing master course in epidemiology along with hospital administration. only few institutions about . % provide master course in public health with focus mainly on health administration. therefore, approximately . % of health science faculty members and . % of students had the opinion that there is a need to establish educational programs in saudi universities related to public health. according to the . % employed students, there is a need of public health specialty especially for the development of new public health departments. in the present study, % of the public health related organizations showed interest in bridging course for their experienced employees. this finding is supported by . % of the students working in health organizations who reported organization cares for their public health studies ( figure ). this reflects the organizations in public health need their employees to be up-graded to stand the competency required in the field. this gives a positive signal for the academic institutions to introduce more post-graduate courses in the public health as the demand for this course is increasing. the online courses can be considered as promising new development for continuing education and bridging courses. the development programs as training programs in epidemiology and public health interventions network and online courses should be viewed as a component of, or adjunct to, internal capacity development, but not as a replacement for it [ ] . the demand for competent public health workforce will further increase as the government is focusing on enlarging the network of health services at phc level to reach all the corners of the country [ ] . moreover, the government project of the custodian of the two holy mosques has planned to create around highly developed phc center and also to upgrade the existing phc center with wellequipped buildings, skilled and competent workforce, this will result in high demand of public health courses in the ksa [ ] . according to the demand of organizations, students and faculty members, mph program needs to focus on disciplinary areas such as epidemiology, infection control, food safety, and environmental and occupational health sciences. the mph degree program development needs to emphasize on student centered learning, problem resolving and gaining of skills necessary to the practice of public health. the lack of resemblance between the taught and required could affect in public health workers being ill-prepared for the requirements of the real world [ ] . therefore, educational institutions should spread the health education by engaging the whole of society through community outreach programs. the study from hawai'i also assessed the needs for public health education in their state and reported lack of awareness about the mph and ms programs in university of hawai'i [ ] . a study from nepal reported there is a need for trained public health professionals in nepal and educational institutions requires development of effective graduate programs [ ] . the accreditation of the public health schools is an essential step toward the improvement and standardization of teaching programs as well as the establishment of competencies [ ] . the affiliations of sph to the local government will probably improve the balance between the needs of government and the autonomy of academic schools [ ] . the public health schools should focus on research process of public health such as planning, evaluation, surveillance, investigation, and problem and pathway analyses. building of wellorganized public health educational institution requires structuring strong research and development skills among students, practitioners and faculty equally. the accreditation of sph with local government will likely promote targeted research with appropriate funding. moreover, students who participated in this study had limited information about the place of work and public health-related organizations demand of sub-specialty in the ksa. the students report convened by welcome trust highlighted that the health improvement can be achieved only when people are fully engaged in their own health and the health service is focused toward the promotion of good health and prevention of illness [ ] . the youth should be updated about the scope of public health and encouraged to take admission in various public health courses, as it will elevate their general awareness of issues that affect individuals, families and communities. this will be a complementary social gain to promote health literacy, and development of a more active civil society in the health field. the efforts and activities in public health in the ksa need more attention. only few universities are providing master course in public health education, which shows that the local educational institutions are not keeping up with the demand for maintaining and improving the public health workforce. the work of public health professionals is important because public health initiatives affect people every day in every part of the world. there is a shortage of expertise in the public health organizations and there is a need for development of more public health schools in the ksa. the establishment of public health courses especially in the field of epidemiology at undergraduate and graduate level will help in the development of efficient and competent public health workforce. the world health report : working together for health. geneva: world health organization global public health: ecological foundations. chapter : comparative organization and function of public health systems multidisciplinarity, interdisciplinarity and transdisciplinarity in health research, services, education and policy: . definitions, objectives, and evidence of effectiveness dual perceptions of hrd: issues for policy: sme's, other constituencies and the contested definitions of human resource development disease and discovery: a history of the johns hopkins school of hygiene and public health professional education for public health in the united states who will keep the public healthy? educating public health professionals for the st century. institute of medicine of the national academy of sciences the evolution of public health education and training in the united kingdom health professionals for a new century: transforming education to strengthen health systems in an interdependent world liberal education and public health: surveying the landscape dedicated to strengthening the role of public health by improving education and training of public health professionals for both practice and research figure | sub-specialty in public health committee of inquiry into the future development of the public health function. public health in england. the report of the committee of inquiry into the future development of the public health func tion choose your future explore your options, apply to university, and more health care system in saudi arabia: an overview organization of the saudi health system essential medicines and health products information portal a world health organization resource [online database quality of primary health care in saudi arabia: a comprehensive review principles and practice of primary health care mecca bound: the challenges ahead viral respiratory infections at the hajj: comparison between uk and saudi pilgrims health risks at the hajj mathematical modelling of the pandemic h n establishment of public health security in saudi arabia for the hajj in response to pandemic influenza a h n saudi arabia ministry of education report public health education in saudi arabia: needs and challenges regional office for the eastern mediterranean. country cooperation strategy for who and saudi arabia - . world health organization. regional office for the eastern mediterranean the imperative of public health education: a global perspective public health in the middle east and north africa: meeting the challenges of the twenty first century competencies required from public health professionals by health based organizations and the role of academia how can the university of hawai'i meet needs for public health education? results of a students' needs assessment assessment of graduate public health education in nepal and perceived needs of faculty and students public health education in europe: old and new challenges report of the public health sciences working group convened by the wellcome trust: public health sciences: challenges and opportunities the authors declare they have no conflicts of interest. mam contributed in data curation, investigation, project administration, software and supervision. nbj contributed in formal analysis. mam and nbj contributed in resources and writing (original draft). amee, mt, sc, ah and feme contributed in validation and visualization. all authors contributed in methodology and writing (review and editing). key: cord- -bcyotwkf authors: alkire, sabina; chen, lincoln title: global health and moral values date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: bcyotwkf nan shaped differently depending on the morals espoused. a rights-based or equity approach, for example, would be expected to differ from a utilitarian or humanitarian approach. also, an initiative is only partly justified by its moral expediency. of critical importance are factors shaped by knowledge and by institutional interests. moral soundness about why particular global programmes should be advanced may need to be balanced against the imperative of achieving consensus among people of many different moral views. yet, as we argue in the conclusion, moral clarity-as well as knowledge and institutional interests-can usefully shape what, when, and how health initiatives should best proceed. to stimulate discussion, we have selected four major schools of moral values commonly used to justify global health initiatives: humanitarianism, utilitarianism, equity, and rights. we could have analysed other schools, but these four, we believe, encompass a good range of moral positions. there are, of course, both large and important variations within each school. the appeal for charitable acts to meet pressing humanitarian needs is arguably the most common ethical basis for global health action. humanitarianism can be a form of virtue ethics but it also often a humanistic response to evident social problems. the ethos of humanitarianism is embedded in nearly all religions. in a humanitarian approach, people respond to human suffering and realise human fulfilment by acting in a virtuous manner based on compassion, empathy, or altruism. the virtues might be specific or broad. examples of specific acts are charitable tithing among baptists or zakat (charitable donations) among muslims. broadly proscribed virtues encompass such human qualities as generosity, honesty, trustworthiness, integrity, and fairness. among the wealthy, these virtues might be expressed as philanthropy, which often focuses on health. humanitarianism provides the primary ethical basis of voluntary action undertaken by non-governmental organisations (ngos), and is also an important base of public support for official foreign aid. us president george bush in announcing us$ billion in assistance for hiv/aids control described the pledge as a "work of mercy". public opinion polls in the usa consistently show that alleviating world hunger and providing drinking water are worthy of foreign aid from the usa. emphasis on voluntary generosity and self-expression (rather than on duties or obligations) gives humanitarianism a broad appeal to many social groups, corporations, and governments. contemporary appeals to people's humanitarian impulses focus on the giver: who a person becomes by acting well, and how a person realises a sense of accomplishment or fulfilment. there are dangers that those who are helped can be placed in a dependent position, treated as victims not agents. also, the underlying societal rules and structures that generate the social ills are not necessarily addressed. this approach might be more relevant to humanitarian catastrophes than structural approaches that attempt to correct the root causes of social problems. in a utilitarian framework, the value of health is determined by the subjective utility (happiness, pleasure, or desire satisfaction) that it creates for an individual. across all individuals in a society, the ideal state is one that maximises the aggregate utility. health could be valued because it generates utility directly, or because good health is instrumental to other utilitygenerating states, including opulence, or both. many contemporary health policies are based on a form of utilitarianism in which good health is valued as instrumental to maximising aggregate utility. for example, the who commission on macroeconomics and health calculated the costs and benefits of burdens of disease and argued that investing in health would generate economic growth, thereby enhancing incomes and aggregate utility. the utilitarian approach underscores important interconnections between health and other variables. it can show how improving the health of the deprived can be "in everybody's interest"-including the self-interest of people not inclined to altruism. its difficulties, however, are several. first, the instrumental valuation of health demeans it as an intrinsically valued goal in all societies. second, people's self-assessments do not www.thelancet.com vol september , rights were not granted to include this image in electronic media. please refer to the printed journal. necessarily match their observed health status. for example, the self-reported morbidity rates in the indian state of kerala, where life expectancy is - years, are significantly higher than in bihar, where life expectancy is significantly lower; and self-reported morbidity in the usa is higher still. third, it is rather difficult, even theoretically, to aggregate very different kinds of utility together into a single entity. finally, a utility-maximising approach is not directly sensitive to distributional concerns. equity is a relational concept in which ethical assessments are-at least in part-based on distributional features of one or more variable. fortunately, considerable intellectual work has recently been done on health equity and social justice. , building on the work of political philosopher john rawls, amartya sen has addressed some key features of health equity. first, he poses the question of "equity of what?" should equity be evaluated with reference to health achievement or access to health care? sen argues that equity in health should be assessed in terms of health capabilities and achievements rather than healthcare activities. after all, health care is a human activity; what people actually value is the capability to attain good health. he further notes that equitable social processes should inform evaluations of equity in the health space. in some equity domains, such as gender, completely equal distribution of health achievement could be considered unfair because women-whose lifespan in the absence of gender discrimination exceeds that of men-should, under an equity framework, enjoy longer life expectancies. an equity-based evaluation considers not only allocation of a fixed set of health resources, but also allocation of resources between health and other social objectives. equitable approaches to health have carried considerable power in mobilising support for health components of international development. striking disparities in health achievement and emotively powerful arguments of preventable suffering can animate the public and political leaders. an example is the recent call for public funds to expand antiretroviral treatment to hiv-positive people in poor countries. the disparity between the health of those with access to lifesaving drugs and the avoidable deaths among all others evokes the moral imperative to alleviate preventable human suffering caused by the inequitable access to antiretroviral drug therapy. human rights in health are embedded in several un declarations, and they have deep and wide moral bases. legal formulations were created to specify what was argued in the th century to be an inalienable moral claim grounded in the ontological dignity of human beings. human rights can be described as "things which are owed to man because of the very fact that he is man". some human rights can be expressed in the space of capabilities-for example rights to health, or to inclusion. yet rights also add to the capability perspective by invoking duties and obligations on the part of others. because each human being is recognised as an "end", human rights demand obligatory behaviour on the part of the state, firms, groups, and individuals. obligations may be "perfect" (as enshrined in law) or "imperfect" (a general duty to do what one can to help). calls for a rights-based approach to global health have recently grown. extensions of human rights to children and women both contain references to freedom from preventable suffering and freedom to exercise health choices. , the application of human rights to good health has drawn attention to the duties and obligations that people and institutions have towards human beings, viewed squarely as an "end" worthy of dignity. a human rights approach often assumes some health minimum that all people should be able to realise for human dignity. the challenge is to implement the corresponding "incomplete obligations" among communities, institutions, and states where good health depends upon resources, knowledge, technologies, and social action. these ethical schools do not track precisely to any specific health initiative. none of the schools dominates any specific health action, and several schools are often relevant to any single initiative. at present, whether the by initiative was evaluated according to aggregate utility (increasing the utility of people with hiv/aids) or distributional equity (increasing the numbers of people in developing countries who are given antiretroviral treatment), human rights (for health care), or the need www.thelancet.com vol september , rights were not granted to include this image in electronic media. please refer to the printed journal. for humanitarianism (to alleviate the suffering of those with hiv/aids), in all cases action is morally imperative. ensuring a minimal threshold of health might similarly fit well with humanitarianism and human rights, and equity and justice values will require action on behalf of the most disadvantaged. beyond moral values, the selection of global health initiatives is shaped by other, often implicit but no less valid, factors. among these are knowledge and institutions. to a large degree, ethical assessments will rest not only on the ethical perspective chosen, but also on the information selected for examination. the selection of information is shaped by political and scientific forces as well as by moral theories. paul farmer has written eloquently about the selective scrutiny of information that shapes health action. tuberculosis, especially multidrug-resistant tuberculosis, became recognised as a health crisis when it achieved rapid transmission in new york city. yet tuberculosis-before, during, and after the new york crisis-kills million people annually, most of whom are poor. because of informational selectivity, tuberculosis is a silent crisis among the world's poor, invisible to the rich and powerful. similarly, severe acute respiratory syndrome (sars) achieved front-page news because of its lethal nature and the paralysing effect it had on global commerce. yet, "sars-like" health catastrophes take place daily in thousands of rural villages in low-income countries. these health problems likewise severely affect families and communities, who are invisible to better-off and protected communities. scientific knowledge provides the basis for research and development of health technologies, such as vaccines and drugs. breakthroughs in health research raise moral challenges because they make feasible treatment for conditions that were hitherto incurablefor example, antiretroviral drugs for hiv. morally, there is a big difference between inevitable human calamity and suffering that can be prevented by modern technology. growing knowledge gaps between technological potentiality and health realities present huge ethical challenges. contention is further fuelled if the gap is accentuated by commercial interest. recent debates over affordable access to life-saving antiretroviral drugs have focused on the fairness of international regimes of intellectual property rights that are perceived to favour commerce over human health. global health, like other fields, has a cluster of institutional stakeholders. governments and intergovernmental agencies like the un and the world bank are mandated to play technical, financial, and operational roles. since health is a major component of the global economy, corporations have interests in profits as well as in protecting their public reputations. civil society organisations have many roles, ranging from the direct delivery of services to advocacy on public policies. institutions, like all actors, are endowed with certain capabilities and also seek to advance their bureaucratic, political, and financial agendas. one typical driver of organisational behaviour is to gain command over resources that can translate into more jobs, higher status, and more numerous activities. tracking of financial flows in global health initiatives can help reveal institutional winners and losers. historical studies have examined these institutional motivations in global health. the work of the rockefeller foundation overseas, for example, was often linked to corporate interests and political propagation of capitalism. in an excellent historical analysis of tuberculosis control in mid- th century, sunil amrith postulated that the conduct of tuberculosis programmes was primarily shaped by the state of knowledge and the capabilities of global institutions. field research had shown that directly observed therapy (dots) was highly effective in curing tuberculosis in home-based settings. endowed with new knowledge, yet limited by institutional capacity and scarce funding, who decided to pursue tuberculosis control through vertical programmes involving cadres of specifically tasked field workers rather than attempt to build holistic villagebased primary services. the latter approach would have been far more demanding institutionally and financially. a common usage of moral values is to mobilise public support. sometimes, however, advocates of global health do not give an accurate representation of distinct ethical schools, simply because they want everyone to agree. braveman and groskins, for example, argued that the concepts of equity and rights are essentially identical, and lead to similar strategies. their aim seems to have been advocacy for certain types of health actions rather than for clarification of distinctive moral schools. de cock argued that a public health rather than a human rights approach should frame responses to hiv/aids in africa, but again this analysis is based on a very narrow example of both ethical schools. we argue that clarity in thinking is essential, because different moral schools do indeed raise distinct considerations and it can be useful to evaluate these carefully. at the same time, the urge to seek consensus is also valid, and can be sought without either exaggerating differences, or claiming (inaccurately) that differences between moral schools do not exist. a common usage of moral values is advocacy, often to rich and powerful leaders, institutions, and nation states with the goal of mobilising resources-finance, political will, human motivations-on behalf of particular health action. but here we run into an apparent paradox: how can one use moral values as advocacy tools, when the moral schools are distinct, and when people argue passionately among them? in order to achieve the support, global health programmes also must build consensus among a diverse constituency of resource-holders as to the central value of the initiative. so when it comes to the language of why support for global health is important, we recognise, with cass sunstein, the wisdom of seeking "incompletely theorized agreements" in the moral discourse surrounding global health. in his tanner lectures in human values, sunstein argued that in some cases consensus can be achieved if participants refrain from elaborating their moral positions, because if they scrutinised these positions in depth, consensus could fracture. by contrast, he advocates an approach that "enlists silence, on certain basic questions, as a device for producing convergence despite disagreement, uncertainty, limits of time and capacity, and heterogeneity". sunstein's approach has the advantage of opening space for dialogue, exchange, and discussion, thereby promoting deliberative democracy, political accountability, and reason-giving. incompletely theorised agreements satisfy diverse constituencies who might have very different reasons, including incompatible values, for supporting a particular activity. there is a further point against requiring everyone to agree on only one ethical justification for global health. for not only might different approaches appeal to different groups, different people might also have distinct understandings of what the terms "rights", "equity", or "humanitarianism", actually mean. after all, the support base of global health initiatives is diverse, ranging from heads of state to private-sector executives to religious leaders to activists from ngos to opinion-setters and journalists. it is highly unlikely that these constituencies will share an identical understanding of ethical terms. a global health initiative can receive emphatic support from people who do not necessarily agree on the ethical foundations for their support, and in fact may very clearly disagree with one another as to why a programme should proceed-ie, its ethical or metaphysical justification. advocates of global health initiatives would thus do well to proceed with a general appeal to moral concepts such as social justice and compassion, and this generality belies prudence rather than a lack of moral rigour. yet an eclectic appeal to moral values in order to garner support of global health initiatives is not to imply that distinctions among moral values are trivial. beyond clarifying why an action is important, adopting a particular moral approach can influence health action in other deeply important ways. first is the scope of health action. an example is the programmatic implication of pursuing access to health care versus equitable distribution of health outcomes. in the former case, the programme would invest heavily in building health clinics and outposts, and perhaps in increasing the ratio of medical personnel per citizen. this sounds very appealing until one recognises that a country may have many rural health outposts, and many doctors on salary role, but if these doctors do not turn up to work, and the outposts do not have adequate pharmaceutical supplies, the population's health outcomes might remain very poor. on the contrary, to achieve an equitable distribution of health outcomes it would be necessary to make sure that the investment in health care results in better health across the population. it would also then be necessary to address broader social determinants of health, such as that raised in michael marmot's intriguing research on the under-recognised relation between socioeconomic inequality and health. second, different ethical schools (and different groups within them) may shape how global health programmes are undertaken. charitable acts might treat people as passive recipients of generosity, whereas rights-based approaches would encourage "voice" and participation to strengthen the agency of people for achieving their inherent rights. third, advocacy might use moral values to advance a global health agenda-because they are effective in advancing a global agenda. to mobilise a compassionate response, a picture of a feeble, emaciated, and large-eyed child might be used to stir pity among donors. such advertisements tend to view the poor as helpless victims, rather than people who could be empowered to care for themselves. arguably, much harm has been done by such dehumanising advocacy techniques. yet, it could be argued that such moral approaches are legitimate to use because they are more effective in evoking public support than other moral approaches. when people speak of ethics, the contribution that most readily leaps to mind is motivational: that an appeal to moral values will motivate people to support a set of actions. yet this is only one of the ways in which moral values can support global health initiatives, and is not necessarily the most powerful. discussions on whether to frame the objective of global health initiatives in terms of access to health care, or capabilities for good health, or utility maximisation, help to clarify what global health initiatives seek to accomplish. criteria such as efficiency, or equitable treatment for men and women, clarify which alternative actions to realise similar goals should be selected. consideration of how health activities contribute to or block non-health objectives such as the support of agency, or the rights to self-determination, clarify the importance of how health initiatives are carried forward. thus global health may be far easier to achieve if we pause to follow through different moral analyses and thereby clarify what, which, and how global health initiatives can best proceed. science and the health of the poor speech at the world health assembly health at the world summit on sustainable development philanthropy and health. london: king's college introduction to the principles of morals and legislation. london: the athlone press, . who commission on macroeconomics and health. macroeconomics and health: investing in health for development health: perception vs observation inequality reexamined challenging inequities in health: from ethics to action public health, ethics, and equity why health equity? the rights of man and natural law. london: geoffrey bles, the centenary press human development and human rights: human development report convention on the rights of the child vienna declaration and programme of action informational analysis of moral principles infections and inequalities: the modern plagueupdated edition with new preface rockefeller medicine men: medicine and capitalism in america plague of poverty? the world health organization, tuberculosis and international development, c - poverty, equity, human rights and health: policy and practice shadow on the continent: public health and hiv/aids in africa in the st century legal reasoning and political conflict aristotelian justice and health policy: capability and incompletely theorized agreements is inequality bad for our health key: cord- -y yra r authors: richardson, e. t.; malik, m. m.; darity, w. a.; mullen, a. k.; malik, m.; benton, a.; bassett, m. t.; farmer, p. e.; worden, l.; jones, j. h. title: reparations for black american descendants of persons enslaved in the u.s. and their estimated impact on sars-cov- transmission date: - - journal: medrxiv : the preprint server for health sciences doi: . / . . . sha: doc_id: cord_uid: y yra r background in the united states, black americans are suffering from significantly disproportionate incidence and mortality rates of covid- . the potential for racial-justice interventions, including reparations payments, to ameliorate these disparities has not been adequately explored. methods we compared the covid- time-varying rt curves of relatively disparate polities in terms of social equity (south korea vs. louisiana). next, we considered a range of reproductive ratios to back-calculate the transmission rates {beta}i[->]j for cells of the simplified next-generation matrix (from which r is calculated for structured models) for the outbreak in louisiana. lastly, we modeled the effect that monetary payments as reparations for black american descendants of persons enslaved in the u.s. would have had on pre-intervention {beta}i[->]j. results once their respective epidemics begin to propagate, louisiana displays rt values with an absolute difference of . to . compared to south korea. it also takes louisiana more than twice as long to bring rt below . we estimate that increased equity in transmission consistent with the benefits of a successful reparations program (reflected in the ratio {beta}b[->]b / {beta}w[->]w) could reduce r by to %. discussion while there are compelling moral and historical arguments for racial injustice interventions such as reparations, our study describes potential health benefits in the form of reduced sars-cov- transmission risk. as we demonstrate, a restitutive program targeted towards black individuals would not only decrease covid- risk for recipients of the wealth redistribution; the mitigating effects would be distributed across racial groups, benefitting the population at large. the novel coronavirus which causes covid- was first reported in hubei province, china in december . in the ensuing months, the outbreak spread to nearly every country in the world. as of may , the united states had the highest number of reported cases of covid- with , , confirmed infections and , total deaths -although this certainly represents an underestimate of the true number of cases given the poor scale-up of testing coupled with a high rate of asymptomatic infection. , as has been the case in previous pandemics, communities of color are suffering from disproportionate incidence and mortality rates of covid- . , in the states that have released data by race, this gap is notably pronounced among black americans who are dying at an ageadjusted rate that is . times as high as the rate for whites. it further adds to vast disparities in black and white health that have been the cumulative result of legacies of slavery, legal segregation, white terrorism (e.g., lynchings during the jim crow period), hyperincarceration, lethal policing, and ongoing discrimination in housing, employment, policing, credit markets, and health care. [ ] [ ] [ ] while frameworks for understanding the mechanisms through which biosocial forces become embodied as pathology are inchoate, allostatic load (the physiological profile influenced by repeated or chronic life stressors) can be used to demonstrate how the continuous trauma of oppression can lead to disparities in health by race. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] the potential for racial-justice interventions, including reparations payments, to ameliorate these disparities, has not been adequately explored. mathematical and computational models of infectious disease transmission dynamics increasingly are being used to determine the potential impact of interventions on incidence and mortality. fundamental to this work is calculation of the basic reproductive number r , which is defined as the expected number of secondary cases caused by a typical infected individual in a fully susceptible population. while r provides theoretical information about an epidemic, practical control ultimately depends on the expected infections generated later in the outbreak prompting epidemiologists to utilize the effective reproduction number rt (i.e., the average number of secondary cases generated by an infectious individual at time t), which obviates the assumption of a fully susceptible population and allows for the temporal dynamics to be followed in the setting of various interventions. models must make assumptions about how people interact with others, but they rarely account for social forces like institutional and cultural racism that structure such interactions. therefore, they can obfuscate such forces in their attempts to describe outbreak transmission dynamics. [ ] [ ] [ ] nonetheless, it is possible to incorporate risk heterogeneities into models, and to use this information to identify more just measures for disease prevention/control. [ ] [ ] [ ] [ ] [ ] for example, black workers are overrepresented in front-line sectors like food service and delivery, healthcare, and child-care, which places them at higher risk of sars-cov- infection. furthermore, black individuals have a higher likelihood of living in dense, precarious housing where effective social distancing is hindered. these risks are structural-that is, not determined by personal choice or rational assessment, as models often assume (what koopman and longini refer to as "the erroneous attribution of individual effects" ); , they could therefore benefit from structural interventions. as such, the following modeling study explores the potential effects of reparations payments on the disproportionate covid- risk among black people in the u.s. for a representative inegalitarian state in the u.s., we chose louisiana as a unit of analysis due to the availability of covid- data compiled by race. louisiana has one of the highest gini coefficients (a measure for household income distribution inequality-a value of represents total income equality [all households have an equal share of income], while a value of represents total income inequality [one household has all the income]) among the american states ( . ), is highly segregated between black and non-black populations (supplemental table ), and has significant differences in the average number of persons per room (ppr) for black and non-black populations ( figure ). (ppr is a measure of overcrowding that recent reports indicate might be a more important for risk of infection than urban density. ) as of may , the state reported , sars-cov- infections. we estimated timevarying (instantaneous) rt using the method of wallinga and teunis, which uses a probability distribution for the serial interval (i.e., the time, in days, between symptom onset in an index case and symptom onset in a person infected by that index case). confidence intervals for rt were calculated using a normal approximation for the estimated number of secondary cases per case (i.e. approximating the % central interval by the expected value rt +/- . times the standard deviation). following current best estimates of the serial interval, we chose a gamma distribution with a mean of and standard deviation of . , all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . to juxtapose these data with those reported from a relatively egalitarian polity, we conducted a similar analysis of the outbreak in south korea, which in contrast to louisiana, has a gini coefficient of . and no large, segregated subgroup of the population composed of the descendants of enslaved persons. south korea nonetheless has times the population density of louisiana such that, if density per se were the major determinant of epidemic severity, we would expect rates of infection to be much higher in the former compared to the latter, which is not the case (louisiana has reported nearly times the number of cases per , people as south korea). , , , to estimate the effect prior reparations payments may have had on the outbreak in louisiana, we considered reproductive ratios from the range of pre-intervention rt (a stay-at-home order was issued on march ). from the theory of epidemics in structured populations, we know that all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . takes louisiana more than twice as long to bring rt below , the critical value at which an outbreak will die out in a population ( days vs ). our next-generation matrix analysis shows that, in a segregated society like the u.s. where sars-cov- transmission rates are disproportionate across racial groups, small changes in the ratio between bb®b and bw®w can result in large changes in the reproductive ratio for the population (figure a) , due mainly to ) the effects of high assortative mixing structured by racism on the value of cb®b; and ) the fact that the expected number of secondary infections generated within high-risk subgroups (i.e., the value gb®b in the next generation matrix-in this case driven by high relative values of cb®b) comes to dominate r for a population. , a program of reparations has the potential to reduce several variables that determine the covid- reproductive ratio in such a segregated society. these include i) reducing ci®j significantly for black people by decreasing overcrowded housing (this also has the benefit of improving an individual's ability to social distance once stay-athome orders are enacted); ii) reducing bw®b as black individuals would not be forced as frequently into high-risk frontline work-with both attendant exposure and psychosocial stress; iii) decreasing t slightly on account of people's ability to access preventive modalities like masks, hand sanitizer, etc. all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . accordingly, the arrow in figure b shows how different assumptions regarding the effects of reparations could play out: it begins within the range of r we selected from the louisiana outbreak pre-intervention (i.e., before the stay-at-home order was enacted); it ends within our estimates for r in the setting of reparations, which are consistent with early values of rt estimated for south korea and are to % lower than pre-intervention estimates for louisiana. this is achieved by the transmission rate bb®b decreasing to near parity with bw®w, which reflects the anticipated mitigation in structural racism a successful reparations program would engender. the color line (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint the greatest impact on the epidemic for the population at large. reducing severe inequalities is thus not simply just, it is epidemiologically efficacious for outbreak containment. in general, a program of reparations is intended to achieve three objectives: acknowledgment of a grievous injustice, redress for the injustice, and closure of the grievances held by the group subjected to the injustice. ) changes in the built environment, fostering the ability to social distance; ) spreading out of front-line work across racial groups; ) decreased race-based allostatic load. current explanations of excess covid- risk for black americans focus on personal failure to follow public health advice and lifestyle choices that result in co-morbid conditions (e.g., coronary artery disease and diabetes). neither, however, addresses excess exposure, which is structured by institutional racism (and captured in the parameters bi®j). indeed, reported mortality rates up to times that of white populations likely reflect considerable underdiagnosis of cases in black communities, rather than intrinsic differences in risk of death once infected. in other words, while there is some differential mortality by race for covid- (exacerbated by allostatic load), incidence is likely much higher in black communities than we appreciate. all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint contrary to the way it is often depicted popularly, r is not an intrinsic property of a particular pathogen (nor are mortality rates ). rather, the reproduction ratio encapsulates social structure, behavior, and differential risk in a population. such risk is often structural, however, and modeling studies seldom capture oppressive social forces such as institutionalized racism and sexism in their emphasis on 'objective,' well-defined parameters. while some scholars attribute this to the inherent conservatism of causal reasoning, , it may be more justly described as a form of symbolic violence, referring to the ways naturalized symbols and language sustain relations of oppression. [ ] [ ] [ ] [ ] in the case of epidemic modeling, we rarely are presented with racial-justice interventions as ways of preventing and containing outbreaks. accordingly, this paper has utilized the properties of mathematical models of infectious diseases to illustrate how pandemic containment policy can go beyond the wearing of masks and stay-at-home orders: interventions in risk structure-that is, the way people are enabled or constrained in their associations with others-are crucial to pandemic preparedness, the ability to comply with containment policy once it is decreed, and racial justice in general. such an amelioration of structural risk can be achieved with reparations. since reparations have not been enacted, however, 'reopening' american society early (after coronavirus-forced shutdowns) will have a disproportionate adverse mortality effect on black people, an effect that is predictable. therefore, de facto, it resembles a modern tuskegee experiment, since massive wealth redistribution could avert these deaths, just as penicillin would have in the nearby state of alabama. , as the apm research lab has reported, "if they had died of covid- at the same rate as white americans, about , black americans, , all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint latino americans and asian americans would still be alive" -and this is before even % of the national population has been infected. the appalling evidence of racism embodied as disproportionate covid- incidence and mortality for black americans should add to moral, historical, and legal arguments for reparations for descendants of slaves. all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . world health organization. novel coronavirus -china centers for disease control and prevention. locations with confirmed covid- cases. centers for disease control and prevention. cases of coronavirus disease (covid- ) in the u.s. the lost month: how a failure to test blinded the u.s. to covid- . the new york times covid- : four-fifths of cases are asymptomatic, china figures indicate communities of color at higher risk for health and economic challenges due to covid- racial disparities in exposure, susceptibility, and access to health care in the us h n influenza pandemic racial and ethnic disparities in population level covid- mortality the racial disparities of coronavirus point yet again to the need for reparations. the philadelphia inquirer improving the health of african americans in the usa: an overdue opportunity for social justice the african american petri dish infections and inequalities: the modern plagues under the skin: using theories from biology and the social sciences to explore the mechanisms behind the black-white health gap integrating biology into the study of health disparities forced removals embodied as tuberculosis structural racism and health inequities in the usa: evidence and interventions allostatic load burden and racial disparities in mortality skin color, social classification, and blood pressure in southeastern puerto rico lifetime discrimination burden, racial discrimination, and subclinical cerebrovascular disease among african americans covid- and the limits of public health 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survey briefs from here to equality: reparations for black americans in the twenty-first century emerging infections and nested martingales: the entrainment of affluent populations into the disease ecology of marginalization forty acres and a mule in the st century racial health disparities and covid- -caution and context the color of coronavirus: covid- deaths by race and ethnicity in the the ebola suspect's dilemma contact structure, mobility, environmental impact and behaviour: the importance of social forces to infectious disease dynamics and disease ecology an anthropology of structural violence is the "well-defined intervention assumption shackling the identification police. cambridge the sociology of pierre bourdieu six sideways reflections historicizing historical trauma theory: troubling the trans-generational transmission paradigm the symbolic violence of 'outbreak': a mixedmethods, quasi-experimental impact evaluation of social protection on ebola survivor wellbeing tuskegee and the health of black men racism and research: the case of the tuskegee syphilis study key: cord- -ua qps r authors: golechha, mahaveer title: covid- , india, lockdown and psychosocial challenges: what next? date: - - journal: int j soc psychiatry doi: . / sha: doc_id: cord_uid: ua qps r nan a world pandemic threat covid- mitigation is crucial to the human life and for reducing distortion of livelihood. the covid- pandemic has swept into more than countries with considerable confirmed cases and deaths and has caused public panic and mental health stress (huang & zhao, ) . most of the nations across the world have implemented complete lockdown with stringent social distancing measures for breaking the chain of transmission. the current outbreak of covid- is heavily impacting the global health and mental health. despite all resources employed to counteract the spreading of the virus, additional global strategies are needed to handle the related mental health issues (torales et al., ) . this outbreak is leading to additional health problems such as stress, anxiety, depressive symptoms, insomnia, denial, anger and fear globally (torales et al., ) . to protect people and prevent the spread, it is critical that public mental health paradigms and measures are used . on january , india reported first case of covid- and the numbers have risen steadily since then, albeit at an alarming rate in the final days of march. aiming to control community transmission, the world's largest democracy has implemented world's largest nationwide lockdown since march (the lancet, ). the country remains vulnerable towards covid- , given the high population density, socioeconomic fabric and overstretched health-care infrastructure. the total lockdown was the only immediately available, best and ideal solution to the control covid- pandemic in india. the indian government has responded appropriately, adequately and quickly to the covid- pandemic at multiple levels. the lockdown has helped india in buying crucial time: time for extensive contact tracing, time to ramp up testing and most crucially, time to prepare our health system, increasing its health-care infrastructure and preventing it from overwhelming, as it happened in italy, the united states and spain. the lockdown is an effective strategy for containing the spread of infection. however, this is very challenging with added difficulty for larger sections of the society. the social distancing is very difficult for many households in india, especially slum areas; the daily-wage earner has to earn daily money to keep family alive, and people with existing mental health illnesses face severe issues. a long-time lockdown may lead to psychosocial difficulties for vulnerable population and consequently lead to stress, anxiety, frustration, boredom and depression and even suicidal idea and attempts. the lancet psychiatry ( ) also highlighted the mental health needs of vulnerable groups, including those with severe mental illness, learning difficulties and neurodevelopmental disorders, as well as socially excluded groups such as prisoners, the homeless and refugees. nevertheless, the burden of this infection on the global mental health is currently neglected even if it may challenge patients, general population as well as policy makers and health organisations and teams (torales et al., ) . india's health inequalities, flaring economic and social disparities and distinct cultural values had made lockdown a hard measure for the poorer sections of the society. the nationwide lockdown has maximised economic loss and simply debilitated the country's large population of dailywage earners and migrant labourers and become an important mental health problem. the emerging mental health issues related to this global event may evolve into longlasting health problems, resulting in isolation and stigma for vulnerable population in the country. the extended lockdown will lead to economic hardship, famine, psychosocial challenges and law and order issues, which may in turn undermine benefit gauge by lockdown and covid- containment objectives. in indian settings, this may exacerbate health inequalities and reinforce the vicious cycle between poverty and ill health. the social and economic issues due to covid- pandemic will result in mass unemployment, depleted social safety nets, homelessness, increase in gender-based violence, alcoholism, hunger, loan defaults and millions slipping into poverty. this post-covid landscape will definitely leads to an increase in mental health issues such as chronic stress, anxiety, depression, alcohol dependence and self-harm. recent evidences in psychosocial sciences also show that similar pandemics increased the prevalence of symptoms of post-traumatic stress disorder (ptsd), as well as confusion, feeling of loneliness, boredom and anger during and after quarantine (brooks et al., ) . the ministry of health and family welfare, government of india has taken several steps to deal with mental health challenges posed by covid- , which includes development of various guidelines in collaboration with national institute of mental health and neuroscience. the guidelines aimed at enhancing resilience of vulnerable populations against mental health issues. the ministry of health and family welfare has also established helpline for behavioural and psychosocial help. however, a lot needs to be done, including capacity building of frontline health-care worker and a large-scale public engagement campaign to increase help-seeking, creating and spreading awareness through mainstream media and social media giants. the real need is to build community-based capacity to handle local issues long after the acute phase of the epidemic. a small team of peer counsellors work under a local administrator and trained on community mental health issues. it is time to build mental wellbeing and resilience into schools, the community and their families. we need a systemic approach to build the demand for mental wellbeing. the government of india's rashtriya kishor swasthya karyakram (national adolescent health programme) can play a pivotal role in social and behavioural change and enhance adolescent resilience against mental health challenges posed by the pandemic. furthermore, the government should give special attention to systematic psychological health care which is required by health-care staff and patients, and systematic psychological self-care must be given a high priority in coping with the detrimental impacts of covid- and social distancing (matias et al., ) . the nationwide lockdown has proven as a successful strategy for india, and it has also helped in containing the spread of covid- across various states. the lockdown has already achieved the desired effect of flattening the epidemic curve (the lancet, ). therefore, it is right time for india to plan quick gradual, phased and calibrated withdrawal strategy. a well-planned calibrated multiphase exit strategy will be required post lockdown. india can end the lockdown now and additional revenue available from the revival of the economy can be spend on increasing testing, isolation facilities, hospital beds, critical care and comprehensive information, education and communication (iec) on social distancing and mental health and addressing the mental health issues of vulnerable population post lockdown. the country can gain much more through continuation of bans on mass gatherings, school closure, restriction of movement of elderly population and children below the age of years, covering mouths and noses in public, spitting bans, physical distancing to the extent possible in public places and expanded testing. mental health support and followup should be provided even months after the release from isolation for those individuals with prior vulnerable mental health status. meanwhile, india should increase the testing. when we look at the rate which screening is being done, india ranks at the lower end of the spectrum. the country needs 'exponential' ramping up of testing to leverage the benefit provided by nationwide lockdown. the panacea against prolonged lockdown and for reassuming economic activity is large-scale testing. the importance of community involvement, awareness and behaviour change cannot be undermined in the current situation, especially for psychosocial issues due to covid- . risk communication and community engagement is a critical component of the response to covid- (world health organization (who), ). this crisis is not going to be controlled without community participation because ultimately control is based on individual behaviour. the government should take various measures like behavioural change communication, hand washing facilities and improving availability and accessibility of community-based mental health services. community psychological interventions and support might have some effects in reducing ptsd symptoms and depressive and anxiety symptoms in adults during these stressful events. this is an opportunity for india to recognise the importance of strong public health systems and increasing investment in health for making its health system resilient towards future pandemic. the governments need to step up to protect their populations and people in a nonthreatening, non-panicky manner to ensure safety of all individuals. the country should focus more on improving primary care, health-care infrastructure and human resources for health. india's public health-care system is chronically underfunded (at just . % of gdp; chetterje, ), leaving primary care weak. this pandemic could be the much-needed wake-up call to the necessity of long-term changes to india's health system. mahaveer golechha is alumnus of aiims, new delhi; lshtm, uk and london school of economics. mahaveer golechha has developed the concept, gathered various information, developed initial draft and also written the manuscript. the author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article. the psychological impact of quarantine and how to reduce it: rapid review of the evidence gaps in india's preparedness for covid- control. the lancet infectious diseases chinese mental health burden during the covid- pandemic mental health and covid- : change the conversation human needs in covid- isolation the outbreak of covid- coronavirus and its impact on global mental health pandemics, panic and prevention: stages in the life of covid- pandemic the author(s) received no financial support for the research, authorship and/or publication of this article. mahaveer golechha https://orcid.org/ - - - key: cord- -szll znw authors: serrano-ripoll, m. j.; ricci cabello, i.; jimenez, r.; zamanillo-campos, r.; yanez juan, a. m.; bennasar-veny, m.; sitges, c.; gervilla, e.; leiva, a.; garcia-campayo, j.; garcia-buades, e.; garcia-toro, m.; pastor-moreno, g.; ruiz-perez, i.; alonso-coello, p.; llobera-canaves, j.; fiol-deroque, m. a. title: effect of a mobile-based intervention on mental health in frontline healthcare workers against covid- : protocol for a randomized controlled trial date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: szll znw aim: to evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against covid- in spain. design: we will carry out a two-week, individually randomised, parallel group, controlled trial. participants will be individually randomised to receive the psycovidapp intervention or control app intervention. methods: the psycovidapp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. healthcare workers having attended covid- patients will be randomized to receive the psycovidapp intervention (intervention group) or a control app intervention (control group). a total of healthcare workers will be necessary to assure statistical power. measures will be collected telephonically by a team of psychologists at baseline and immediately after the two weeks intervention period. measures will include stress, depression and anxiety (dass- questionnaire - primary endpoint), insomnia (isi), burnout (mbi-hss), post-traumatic stress disorder (dts), and self-efficacy (gse). the study was funded in may , and was ethically approved in june . trial participants, outcome assessors and data analysts will be blinded to group allocation. discussion: despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. this study will help increase the scientific evidence regarding the effectiveness of this type of intervention on this specific population and context. impact: despite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. the findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits. the current covid- pandemic is posing unprecedented challenges for health systems and healthcare workers (hcws) alike. worldwide, hcws are facing increased workloads, are at high risk of infection (for themselves and their cohabitants) [ ] [ ] [ ] , and lack of resources to handle the situation. as a result of having to make decisions such as how to provide care for severely unwell patients with constrained or inadequate resources, or how to balance their own physical and mental healthcare needs with those of patients, they are suffering a moral injury . this extreme situation has important implications for hcw´s mental health . a recent systematic review examining the mental health problems among frontline hcws during viral epidemic outbreaks observed a high prevalence of acute stress ( %), anxiety ( %), burnout ( %), depression ( %) and post-traumatic stress disorder ( %). health services worldwide are implementing strategies to mitigate these psychological consequences, most of which are based on the provision of cognitive-behavioural therapy (cbt) (e.g. united states , france , italy , sierra leone ). however, there is still very limited empirical evidence about the effectiveness of available interventions to protect mental health of hcws during viral pandemics . mobile health (mhealth) interventions are rapidly gaining popularity because of their low cost, high scalability and sustainability features. recent trials have examined the efficacy of mhealth interventions addressing mental health problems, including suicide , schizophrenia , substance use disorders , and psychosis , among others . recent systematic reviews investigating the efficacy of standalone smartphone apps for mental health show that, although they have potential for improving mental health symptoms, the available evidence is still scarce and more rigorous trials are needed . mhealth interventions are well suited to help hcws to combat the adverse effects of working in such high-pressure situations for a prolonged time period for two reasons . first, they can address non-treatment-seeking behaviour (a common issue among hcws ), as they provide the opportunity to engage individuals in need of treatment timely and anonymously by providing portable and flexible treatment. second, they are delivered in absence of face-toface interactions, reducing the risk of infection for sars-cov- . however, their effectiveness in this specific context and population is largely unknown: as observed by a recent review , only % of the studies about mental health apps to assist hcw during covid- included empirical evaluation of the reported interventions. robust, large scale trials are, therefore, urgently needed to determine the extent to which mhealth interventions can improve mental health of frontline hcws. spain is the country with higher mobile phone use rates in the world, with % of users . on may of , spain reported the highest cumulative number of covid- infections among hcws around the world ( , infections -counting for % of all hcw infections worldwide) . the pandemic produced very severe consequence in spanish hcws' mental health, with around % of hcws presenting symptoms of posttraumatic stress disorder, % of anxiety disorder, % depressive disorder, and . % feeling emotionally drained . under is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint these exceptional circumstances, we received funding to develop and evaluate a cbt and mindfulness-based intervention using an mhealth, to protect mental health of spanish hcws attending the covid- emergency. this article describes the protocol for the psycovidapp trial. this protocol trial has been prepared in accordance with the standard protocol items: recommendations for interventional trials (spirit) guidelines . . cc-by-nc-nd . international license it is made available under a perpetuity. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint the aim of this study is to evaluate the effectiveness of a psychoeducational mhealth intervention against a control app intervention, to protect mental health in hcws at the frontline against covid- in spain. the specific objectives are: -to analyse the efficacy of the intervention (in the overall sample and in specific subgroups based on baseline mental health status and use baseline use of psychotherapy and psychopharmaceutical drugs) in reducing the levels of depression, anxiety, anxiety, acute and posttraumatic stress, burnout, self-efficacy, and insomnia. -to examine the usability of the intervention. we will carry out a blinded, two-weeks, individually randomised, parallel group, controlled trial. participants will be individually randomised with an allocation ratio of : to receive either the psycovidapp intervention or control app intervention (both described below). the trial will be carried out in healthcare centres in spain, including hospitals, primary care centres, and care homes. the trial will include male and female hcws aged> , who report having provided healthcare to patients with covid- during the viral outbreak in spain (from the onset of the health emergency to the recruitment time). for this study hcws will be defined as professionals regulated by a health system who deliver care and services whose primary intent is to enhance health. hcws from any medical speciality (pneumology, internal medicine, emergency, primary care, etc.) and role (doctors, nurses, nurse assistants, etc.) with access to a smartphone will be included. we will include hcws who have provided direct, face to face, healthcare to patients with a diagnosis of infection by covid- . this will include healthcare to any health problem patients may experience (i.e., not only caused by covid- ). we will exclude hcws with no access to a smartphone, or not able to download and activate the app used to deliver the intervention during the next days following the baseline assessment in their smartphone. hcws will be considered withdrawn from the study if they retire their consent to participate, or if they do not receive a postintervention evaluation within the next days after the end of is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint the intervention period. reasons for withdrawals and discontinuation of any participant from the trial will be recorded. a flowchart describing the psycovidapp trial procedures is available in figure . we will send invitations to hcws to participate in the trial through social media and key stakeholders hospital managers and communication departments, trade unions of hcws, scientific societies, research institutes, private insurances companies, home care centres and professional colleges). hcws willing to participate will register their interest by completing an online questionnaire, which will contain a participant information sheet. a team of psychologists, who will have previously received a -hour training session (to ensure homogeneity in recruitment, questionnaire administration, and data entry methods), will contact via telephone with registered hcws to confirm eligibility criteria, to obtain informed consent (audio-recorded), to carry out a psychological (pre-intervention) evaluation, and to instruct participants about how to download the clinicovery© app (apploading, inc). clinicovery© is a platform that allows uploading information in multiple formats (text, video, audio) and organize it in modules . these modules are then made available to users of the clinicovery© app. this system has two main advantages that makes it ideally suited for its use in clinical trials: first, the access to the app contents remains under the control of the researchers, who individually activate the contents of the app after hcws have registered (i.e., users cannot access to the intervention with no activation from a member of the research team); second, it allows the researchers to allocate different contents to different groups of users (e.g., intervention and control groups). within hours after participants successfully download and activate the app (user activation of the app will be used as a checkpoint to ensure participants can successfully use it), a member of our research team will load the contents to the app according to the group participants have been allocated to. this procedure will ensure allocation concealment. during the next days, all hcws will continue with their usual care (e.g,. use of psychopharmaceutical drugs or psychotherapy, if any) throughout the study. in addition, the intervention group will have access to contents of the psycovidapp intervention (described below). participants in the control group will only have access to control app intervention (below). after two weeks, the contents uploaded in both groups will be disabled, and a postintervention psychological assessment will be undertaken via telephone. after the postintervention assessment, all participants will be offered free, unrestricted access to the psycovidapp intervention. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint we will randomize patients individually using a computer-generated sequence of random numbers. hcws will be blinded to group allocation. data analysts and outcome assessors (in this case, the psychologists who will undertake the pre-and post-intervention psychological evaluations) will also be blinded. the psycovidapp intervention was developed on may by a group of nine experts (five psychologists, two psychiatrists, and two experts in lifestyle modification), informed by findings from an exploratory qualitative study involving in-depth interviews with eight hcws seeking psychological support, as a result of their professional activity during the covid- pandemic (unpublished results). the intervention developers adhered to current recommendations for the development of mental health apps . the psycovidapp intervention aims to prevent and mitigate the most frequent mental problems suffered by hcws attending the current covid- emergency (depression, anxiety, stress, and burnout). the intervention includes psychoeducational components, and it is based on cbt and mindfulness approaches. the contents are grouped into five main sections (see box ): emotional skills, lifestyle behavior, work stress and burnout, social support, and practical tools. each section contains multiple modules, covering the following areas: i) monitoring mental health status; ii) educational materials about psychological symptoms (e.g. anxiety, worry, irritability, mood, stress, moral distress, etc.); iii) practical tips to manage pandemic-related stressors (e.g., is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint mindfulness, relaxation and breathing techniques, coping strategies, survival skills to emotional crises); iv) healthy lifestyles and practical tips to promote them; v) organizational and individual strategies to promote resilience and reduce stress at work and the burnout syndrome, and; v) promotion of social support. the contents are displayed using written information, audios and videos (see figure ). additional information is offered through links to web pages, articles, guides, videos and audios. all these contents will be permanently available during the -week intervention period. additionally, the intervention includes temporal modules, which are available only for hours. each day the users will be prompted by a notification indicating that a new message is available. these messages contain a brief question followed by a short message. the messages have specific purposes, including: monitoring of mental health status, invitation to practice, reminders, and encouragement. the majority of the temporal modules offer tailored information or recommendations based on users' responses to the brief questions ( figure ). box . description of the content of the psycovidapp intervention  section . emotional skills  knowing and identifying the most common emotional reactions that hcws may experience during or after the covid (depression, anxiety, acute and post-traumatic stress, and burnout)  introduction to mindfulness and audios to start its practice.  emotional regulation: strategies and practical advice (e.g., relaxation exercises through breathing or imagination, jacobson's progressive relaxation, etc.)  tips and tools to improve a period of crisis and/or emotional blunting. section . lifestyle behavior  information on healthy lifestyle (i.e., physical activity, diet, exposure to sunlight, sleep and non-consumption of alcohol and tobacco) and its relationship with psychological well-being  self-assessment of a healthy lifestyle  tips to encourage support of healthy lifestyle behaviors. section . work stress and burnout  informative content about work stress and burnout  practical advice to learn how to handle and prevent work stress and burnout. section . social support  web resources to deepen the concept of social support and its different types  tips to promote social support and integrate it into the own code of social behavior. section . practical tools  compilation of all the practical tools presented in the previous modules is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint participants in the control group will have access through the clinicovery© app to a control app intervention (see figure ) . this intervention will only include brief written information, adapted from a set of materials developed by the spanish society of psychiatry for mental healthcare of hcws during the covid- pandemic. the information is organized in three sections: challenges faced by hcws during the covid- pandemic; common reactions to intense stress situations, and; mental health self-management recommendations. no temporal modules will be available for the control intervention. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint the primary outcome will be the difference between the intervention and control groups in the mean overall score the depression, anxiety and stress scales (dass ) instrument . the score ranges from (worst outcome) to (best outcome). the instrument contains three items scales, assessing presence and intensity of depression, anxiety and stress. items are based on a likert-scale ranging from - points. secondary outcome measures will be the difference between intervention and control groups in the mean scores of the following instruments: . the dts is a -item, likert-scale, self-report instrument that assesses the dsm-iv symptoms of post-traumatic stress disorder. both a frequency and a severity score can be determined. the dts yields a frequency score (ranging from to ), severity score (ranging from to ), and total score (ranging from to ). higher scores are indicative of a worse outcome. the scope of the questionnaire to capture only post-traumatic stress disorders related with the covid- health emergency.  maslach burnout inventory -human services survey (mbi-hss) . the mbi-hss is a item, likert-scale, self-reported instrument that assesses three domains of burnout: emotional exhaustion ( items), depersonalization ( items) and personal achievement ( items). all mbi items are scored using a -level frequency scale from "never" to "daily." each scale measures its own unique dimension of burnout. scales cannot be combined to form a single burnout scale.  insomnia severity index (isi) . the isi is a -item, likert-scale, self-reported instrument assessing the severity of both night-time and daytime components of insomnia. scores range from (best outcome) to (worst outcome). is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint  general self-efficacy scale (gse) . the gse is a -item, likert-scale, self-reported instrument that assesses optimistic self-beliefs to cope with a variety of difficult demands in life. scores range from (worst outcome) to (best outcome).  system usability scale (sus) . the sus is a -item, likert-scale, self-reported instrument assessing subjective assessments of usability. it comprises three domains: effectiveness (whether users can successfully achieve their objectives); efficiency (how much effort and resource are expended in achieving those objectives); and satisfaction (whether the experience was satisfactory). scores range from (worst outcome) to (best outcome). it is estimated that participants ( per group, allowing for % attrition) will be required to detect at least an effect size of . (cohen´s d) on dass with % power and alfa of % (one-sided). the primary statistical analysis will be carried out on the basis of intention-to-treat (itt) (i.e. all participants that agreed to participate will be included in the analysis according to the group to which they were assigned). the study results will be reported in accordance with the consort statements and a full detailed statistical analysis plan will be prepared before recruitment starts (including any interim, subgroup and sensitivity analyses). differences between groups of primary and secondary outcomes will be analysed using general linear modelling (ancova) for continuous variable, adjusted by baseline score. the results from the trial will be presented as regression coefficient for predicting change in primary and secondary outcomes with % confidence intervals. we will use multiple imputation by chained equations (mice) to fill in missing values ( imputation sets) . we will carry out subgroup analyses to examine the impact of the psycovidapp intervention on primary and secondary outcomes according to groups of hcws based on the following baseline characteristics: use of psychopharmaceutical drugs (yes vs. no), use of psychotherapy (yes vs. no), and symptomatology of depression, anxiety, stress (yes vs. no -based on baseline dass- median score). research ethical committee approval was obtained by the research ethics committee of the balearic islands (cei-ib ref no: ib / pi). all potential participants submitting their expression of interest to participate in the study will receive a participant information sheet. an audio-recorded informed consent will be obtained from every participant before data collection via telephone. hcws will be informed of freedom to withdraw at any time and will be assured of anonymity by using special code numbers to identify themselves. all of the collected data will be pseudo-anonymized and kept confidentially. only members of the research team will be able to re-identify the participants. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint validity and reliability this study uses a rigorous research design, an rct with a representative and predetermined sample. it uses instruments with a high validity and reliability, and statistically analysis, which can be seen to reduce bias effectively and enhance the generalizability of research results beyond the target population. moreover, trial participants, outcome assessors and data analysts of the research will be blinded to intervention allocation to reduce the biases in the evaluation of the effects of the intervention. the study design, procedures and reporting will follow the consort statement recommendations on randomized controlled trials . an additional strength of this study is that it will be performed under routine clinical conditions, and with a broad range of hcws. this feature will give strong external validity. the global health emergency generated by the covid- pandemic is posing an unprecedented challenge to frontline hcws, who are facing high levels of workload under psychologically difficult situations with scarce resources and support. there is a growing interest in the use of digital technology to deliver mental health care. however, this area of research is still in progress, and rigorous trials are needed to determine the extent to which these interventions can produce the desired benefits. this study will evaluate a psychoeducational mental health app based on cbt and mindfulness approaches, specifically developed to meet the needs of hcws during the covid- pandemic. this study will help to increase scientific evidence regarding the effectiveness of this type of intervention on this specific population and context. mhealth interventions are already being widely implemented because they are low cost, sustainable and highly scalable, but in absence of solid evidence about its effectiveness. the findings from this study will help health services and organizations to make informed decisions in relation to further development and roll out of this type of interventions, allowing them to ponder not only their attractive implementability features, but also providing robust data on impact on mental health. the study has also some limitations. first, the two weeks follow-up period may be not enough to detect clinically meaningful differences in the selected outcomes. although adherence to mhealth apps generally decrease overtime , and two weeks is enough to access to all the contents of the psycovidapp intervention, a longer period of time may be needed to produce the desired positive effects on mental health. second, restricting the study to hcws with a smartphone and able to download and use mobile apps may cause a selection bias which could reduce the generalizability of our results. this is a common limitation of mhealth trials, and which is unlikely to significantly affect the results of our study, since spain is currently the country with higher smartphone use rates in the world, with % of users .third, the mental health of the participants will not be evaluated through a clinical interview, but rather using instruments indicated for symptomatology assessment rather than for clinical diagnosis. fourth, we will not restrict our sample to hcws with mental health problems at baseline. including a large proportion of participants with no (or minor) mental health problems in our study may limit our ability to observe mental health improvements. fifth, high dropout rates . cc-by-nc-nd . international license it is made available under a perpetuity. is the author/funder, who has granted medrxiv a license to display the preprint in (which was not certified by peer review) preprint the copyright holder for this this version posted november , . ; https://doi.org/ . / . . . doi: medrxiv preprint and low intervention adherence are common limitations of trials of low-intensity interventions, such as the one proposed in our study. sixth, our ability to conduct the planned subgroup analyses may be limited by the size of such groups. seventh, it is worth noting that this trial will be undertaken during a very specific and rapidly evolving context: the covid- pandemic. therefore, rapid recruitment of hcws will be needed to ensure the intervention is homogeneously tested in the same context. although we will allocate resources to recruit through hospitals, professional and scientific societies and hcws unions, the feasibility of such rapid recruitment has not been previously examined. finally, we will not be able to monitor the level of use of the app during the trial, and therefore it will not be possible to determine the extent to which higher intervention adherence is associated with higher benefits on mental health. this research will study for the first time the impact of a psychoeducational cbt-and mindfulbased mhealth intervention specifically designed to protect mental health of frontline hcws fighting against the covid- pandemic in spain. the findings from this study will be used to inform decisions about wider rollout of the psycovidapp intervention immediately after the trial. in addition, the study findings will help increase the scientific evidence concerning the impact of mental mhealth interventions on a specific population (hcws) under a specific context (the health emergency caused by the covid- pandemic); as well as, more generally, the evidence about the effectiveness of mhealth-an area of research still in its early stages, for which robust trials are urgently needed. professional quality of life and mental health outcomes among health care workers exposed to sars-cov- (covid- ) mental health consequences of covid- : the next global pandemic psychological status of medical 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: a scoping review symptoms of posttraumatic stress, anxiety, depression, levels of resilience and burnout in spanish health personnel during the covid- pandemic spirit statement: defining standard protocol items for clinical trials mental health smartphone apps: review and evidence-based recommendations for future developments psycometric properties of the spanish version of depression, anxiety and stress scales (dass) instrumentos básicos para la práctica de la psiquiatría clínica: barcelona: psiquiatría editores, sl factorial validity of the maslach burnout inventory (mbi-hss) among spanish professionals validation of the insomnia severity index as an outcome measure for insomnia research psychometric properties of the general self efficacy- scale in spanish: general and clinical population samples an empirical evaluation of the system usability scale statement: updated guidelines for reporting parallel group randomised trials multiple imputation by chained equations (mice): implementation in stata barriers to the uptake of computerized cognitive behavioural therapy: a systematic review of the quantitative and qualitative evidence we thank the hcws who participated in the individual qualitative interviews to inform the design of the psycovidapp intervention. key: cord- -g r xi t authors: mckee, martin title: learning from success: how has hungary responded to the covid pandemic? date: - - journal: geroscience doi: . /s - - -x sha: doc_id: cord_uid: g r xi t nan in , an international panel of experts developed the global health security index, a measure that ranked the countries of the world in terms of their preparedness for a major threat to health, such as a pandemic (global health security index, ) . it combined a portfolio of indicators in areas such as prevention, detection, and reporting, and ability to mount a rapid response. the choice of measures was informed by evidence of what worked and the overall ranking seemed to make sense. yet, it has not stood the test of time. the usa was ranked first out of countries, with the uk second. yet by no stretch of the imagination could either of their responses be described as effective. brazil was ranked in nd place yet the situation there is catastrophic. hungary came in at only th place yet it has performed far better than many countries that were expected to do much better. inevitably, the first question to ask when undertaking a comparison of health responses is whether the data are accurate. the accompanying paper, by merkely and colleagues, provides reassurance that hungary has indeed managed to control the pandemic (merkely et al., ) . they report a nationwide survey in which subjects were tested for the presence of the covid- antigen, using pcr testing, and of antibodies. they found that evidence of covid- infection was very rare. their central estimate of those testing positive on pcr was . / , . put another way, someone in hungary would have to interact with, on average, others to encounter someone who is infected. consistent with this figure, only . % of the population was found to have antibodies, a marker of previous infection, far lower than the % or so reported from countries that were much harder hit, such as spain (pollán et al., ) . of course, none of these tests is perfect. there are false positives, as when pcrs identify fragments of viral rna after they have ceased to have active infections, and false negatives, for example due to faulty sampling technique (watson et al., ) . there are many outstanding questions about the meaning of antibody tests, with evidence that they may decline in the weeks following infection in some people (seow et al., ) , although fortunately it now seems that this does not equate to declining immunity as responses by t cells are emerging as equally or more important, albeit more difficult to measure. given that sampling for pcr testing is not a pleasant experience, requiring swabs to be inserted into the nasopharynx, the research team is to be applauded for achieving a response rate of %. as they report, this reflected a multi-faceted approach, making full use of connections to communities through general practitioners. the ability to take advantage of these mechanisms reflects a longstanding investment in building links between public health and primary care in hungary (sándor et al., ) . however, we know that, in other countries, covid- infections are much more common among marginalised populations and in those very few countries that collect data on ethnicity, especially among minority ethnic populations (aldridge et al., ) . these groups are often excluded from the sampling frames used in surveys, for example because they are undocumented or seek to remain invisible to the authorities. they may also be reluctant to participate in surveys because of fear of being stigmatised. in hungary, roma have long experienced discrimination, but especially so in recent years (sándor et al., ; fésüs et al., ) . as a consequence, the figures reported must be considered a lower bound of what is happening. yet, even allowing for that, it is clear that hungary has fared much better than many other european countries. why? we can identify three issues that influence how a country will respond: politics; scientific advice; and operational capacity. taking them in reverse order, it is clear that a country will be limited in what it can do if it lacks laboratory facilities. this is especially important with a disease like covid- where, as the accompanying paper reminds us, many of those infected have few or no symptoms yet are capable of transmitting it to others. however, it is also necessary to have a comprehensive system of find, test, trace (contacts), isolate, and support. yet, too often, only some elements are in place and, even then, they may be fragmented and poorly coordinated. obviously, this requires resources. yet, some countries, such as rwanda, have shown what can be done by mobilising the population to help in a variety of roles. hungary, in common with several of its neighbours, is fortunate in having a relatively welldeveloped laboratory system, linked closely to the public health system. responses must, however, be based on the best available evidence. this has been challenging given the rapid growth in research. this has been beyond what could have been imagined even a few years ago. the virus's genome was decoded within weeks of the microorganism being discovered. candidate vaccines are entering phase iii trials only months later. some clinical trials of potential treatments have already been completed. however, countries need to make the right decisions and have the capacity to synthesise this information and present it to decision-makers. while some in sweden still maintain that they made the right choice in refusing to impose lockdowns, instead allowing herd immunity to develop, that position seems increasingly less credible (kamerlin & kasson, ) . hungary was a pioneer in developing public health training in central europe and has benefited from the capacity that this developed (adány et al., ) . neither of these is, however, sufficient, if the politicians refuse to act or act inappropriately. the dangers are all too apparent when looking at the countries that have performed worst, with the usa and brazil led by politicians that have rejected the evidence, instead putting forward a series of often bizarre proposals that defy the basic laws of science, or even any sense of logic (mckee et al., ) . this has undoubtedly cost tens of thousands of lives. again, hungary was fortunate as the government acted extremely quickly, at a time when closing down even a few days earlier could make an enormous difference. so hungary seems to have done very well. yet, a note of caution is required. it is important to recognise that the responses to this pandemic themselves have consequences for health, for example by reducing access to medical care for those with non-covid illnesses. there have been well-publicised concerns about the emptying of hospital beds early in the pandemic in hungary (bayer, ) and aspects of the government's response have featured in the increasingly polarised hungarian political scene (hopkins, ) . covid- has been a test for all our societies. some, like new zealand, have come out of it very well. others, like the usa, england, russia, india, and brazil, have clearly not. hungary is closer to the former than the latter and, as a consequence, can now be more confident in opening up society. but at the same time, there are concerns about the political process. looking to the future, both are important. public health challenges of the st century and the role of schools of public health in central and eastern europe asian and minority ethnic groups in england are at increased risk of death from covid- : indirect standardisation of nhs mortality data hungarian doctors question coronavirus response: politico policies to improve the health and well-being of roma people: the european experience. health policy global health security index hungary's viktor orban comes under fire for coronavirus response: financial times managing covid- spread with voluntary public-health measures: sweden as a case study for pandemic control are populist leaders creating the conditions for the spread of covid- ? comment on "a scoping review of populist radical right parties' influence on welfare policy and its implications for population health in europe novel coronavirus epidemic in the hungarian population, a cross-sectional nationwide survey to support the exit policy in hungary prevalence of sars-cov- in spain (ene-covid): a nationwide, population-based seroepidemiological study public health services provided in the framework of general practitioners' clusters the decade of roma inclusion: did it make a difference to health and use of health care services? longitudinal evaluation and decline of antibody responses in sars-cov- infection interpreting a covid- test result key: cord- -velir gb authors: hickey, jason; gagnon, anita j; jitthai, nigoon title: pandemic preparedness: perceptions of vulnerable migrants in thailand towards who-recommended non-pharmaceutical interventions: a cross-sectional study date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: velir gb background: non-pharmaceutical interventions (npis) constituted the principal public health response to the previous influenza a (h n ) pandemic and are one key area of ongoing preparation for future pandemics. thailand is an important point of focus in terms of global pandemic preparedness and response due to its role as the major transportation hub for southeast asia, the endemic presence of multiple types of influenza, and its role as a major receiving country for migrants. our aim was to collect information about vulnerable migrants’ perceptions of and ability to implement npis proposed by the who. we hope that this information will help us to gauge the capacity of this population to engage in pandemic preparedness and response efforts, and to identify potential barriers to npi effectiveness. methods: a cross-sectional survey was performed. the study was conducted during the influenza h n pandemic and included migrant participants living in border areas thought to be high risk by the thailand ministry of public health. data were collected by migrant community health workers using a -item interviewer-assisted questionnaire. univariate descriptive analyses were conducted. results: with the exception of border measures, to which nearly all participants reported they would be adherent, attitudes towards recommended npis were generally negative or uncertain. other potential barriers to npi implementation include limited experience applying these interventions (e.g., using a thermometer, wearing a face mask) and inadequate hand washing and household disinfection practices. conclusions: negative or ambivalent attitudes towards npis combined with other barriers identified suggest that vulnerable migrants in thailand have a limited capacity to participate in pandemic preparedness efforts. this limited capacity likely puts migrants at risk of propagating the spread of a pandemic virus. coordinated risk communication and public education are potential strategies that may reduce barriers to individual npi implementation. we have recently seen the emergence of two new pathogens that are being closely monitored by public health agencies due to their pandemic potential. one is a new avian influenza a (h n ) virus in china that has developed the ability to transmit from human-to-human. the other is the middle east respiratory syndrome coronavirus with mortality rates above %. discovery of these pathogens highlight the importance for public health officials worldwide to continue pandemic preparedness efforts. one key strategy employed during the previous influenza a (h n ) pandemic was the use of non-pharmaceutical interventions (npis). examining and enhancing individuals' attitudes towards npis is one important area of preparation for a new pandemic. this paper presents data collected during the pandemic about the perceptions of migrants in thailand towards npis and their ability to implement these npis. many potential barriers were identified. non-pharmaceutical interventions such as personal hygiene, cough etiquette, social distancing and border measures constituted the principal tools employed in global efforts to mitigate the influenza a (h n ) pandemic. npis were heavily relied upon during the early stages of the pandemic to slow disease transmission, while work was undertaken to understand the virus and develop a vaccine [ ] . antivirals were available in many countries but potential development of resistance presented a major concern [ ] , highlighting the importance of npis to reduce reliance on antivirals. during future pandemics it is likely that npis will again constitute our principal set of tools to reduce transmission, gain time to put response measures into place and work towards vaccine development. thailand is an important point of focus in terms of global pandemic preparedness and response due to its role as the major transportation hub for southeast asia, the endemic presence of multiple types of influenza, and its role as a major receiving country for migrants. certain groups of migrants may be particularly vulnerable to pandemic influenza due to traditions in raising poultry and swine, poor personal hygiene and sanitation, low levels of health knowledge and awareness, and limited access to health care [ ] [ ] [ ] [ ] . some migrant populations in thailand share these characteristics [ ] . furthermore, migrants' proximity to international borders may increase likelihood of cross-border disease communication and occurrence of future pandemics [ ] . thailand's ministry of public health (moph) works collaboratively with the international organization for migration (iom) to improve the health and well-being of potentially vulnerable migrant groups. iom's work is focused in 'priority provinces' that have been designated as such, based on the high concentration of migrants and frequency of cross-border communication (i.e., movement of individuals and goods). the proportions of migrants compared to thai people living in border areas vary widely and depend on how one defines "migrants". in this context, we define it as any individuals that do not have a thai citizenship, regardless of their places of birth or immigration status. the two studied provinces are among the top five in the country regarding the size of migrant populations. there are an estimated two and a half million migrants providing unskilled labour in thailand, nearly one and a half million being undocumented [ ] . thailand's past experience with avian influenza outbreaks meant that pandemic preparedness guidelines and policies had been put into place prior to the influenza a (h n ) pandemic [ ] . npis, including hand hygiene, social distancing, face masks and border measures were all included in the guidelines, were widely promoted and implemented during the pandemic [ ] . thailand's first case of a (h n ) pdm was reported in early may, . in total, , confirmed cases and resultant deaths were reported [ ] . failure of npis to prevent widespread transmission of influenza a (h n ) pdm highlights the need to identify factors that may reduce the effectiveness of npis during a pandemic. several studies have demonstrated that individual characteristics of non-migrant populations are closely linked to npi adherence [ , ] . an anonymous telephone survey of adults in hong kong revealed perceived efficacy of hand washing and face mask use to be 'quite effective' in nearly % of respondents [ ] . positive perceptions were linked to higher levels of hand-washing and face mask use. another telephone survey of individuals in england, scotland and wales found that perceived efficacy toward disinfection measures and hand washing were quite high (more than % answered 'tend to agree' or 'agree') but was lower towards social distancing, face mask use, and avoiding hospitals [ ] . this study also found an association between perception and npi adherence. both studies highlight the importance of assessing and addressing individuals' perceptions of npis. during the influenza a (h n ) pandemic, iom and the mcgill university school of nursing undertook a study to identify influenza knowledge, attitudes, and practices among migrants in thailand. one assumption guiding a subset of questionnaire development was that it is ultimately an individual decision to adhere to npi recommendations. in addition, the most recent revision of the who guidance document on pandemic preparedness incorporates a more explicit and active role for communities, individuals and families [ ] . the guidance document suggests that respiratory hygiene, hand washing and voluntary isolation of cases may help limit the spread of influenza, but it does not address individuals' willingness or ability to undertake these actions. our aim was to collect information about vulnerable migrants' perceptions of and ability to implement npis proposed by the who. we hope that this information will help us to gauge the capacity of individuals within the vulnerable migrant community to participate in pandemic preparedness and response efforts, and to identify potential barriers to npi effectiveness. study participants (n = ) were recruited from two provinces in northern thailand adjacent to the myanmar and laos borders, chiang rai and tak. participants were sampled from all known migrant-populated communities within these provinces. first, maps created by migrant community health workers (mchws) during a previous iom/moph project that outline the number and locations of households within each community were used to randomly select households. the number of households chosen from each map was based on the proportion of migrants in that village compared to the rest of the province. a web application, research randomizer [ ] was used to randomly generate the specific household numbers to sample. second, data collectors approached members of the selected households and requested a volunteer from each household to complete the survey. the decision to seek volunteers from each household was made after extensive consultation with iom and mchws as the most ethically and culturally appropriate method in this context. consideration was given to sampling the household heads, but it was felt that this would have turned our sample into a predominately male one and put unintended pressure on this person to participate. random selection of individuals was also considered, but it was likely that this method would have been culturally offensive to some groups. data collectors attempted to recruit equal numbers of male and female migrants by requesting a female volunteer from the first household, a male from the second household, a female from the third, and so forth. it was requested that volunteers be between the ages of and without any known psychological disability that would prevent them from completing the survey. interviewer-assisted questionnaires were administered between september and november, by mchws employed by the moph. mchws travelled to the communities where they are known to the migrant population and familiar with the culture and language(s) spoken. participants spoke a range of ethnic languages so mchws were selected who had fluency in one or more of these languages. interviews were conducted in the participant's primary language, in thai, or in a mixture of both, depending on participant's preferences and language abilities. most mchws had been involved in previous health promotion activities and data collection and were familiar with negotiating this communication process. mchws were responsible for describing the purpose of the study, the risks and benefits of participation, obtaining informed consent, and collecting data. all mchws received training on research methodology, survey administration and research ethics prior to data collection. this study received ethical approval from the mcgill university research ethics committee and underwent review by iom for cultural appropriateness prior to recruitment. the subset of data presented in this paper contains information on socio-demographic factors and perceptions and practices relating to the following who-defined categories of npis: measures to reduce risk that cases transmit infection, measures to reduce risk that contacts transmit infection, measures to increase social distance, disinfection measures, and border measures [ ] . a -item interviewer-assisted questionnaire was used to collect data. this instrument was revised from a previous iom influenza questionnaire to incorporate key components of the who's global influenza preparedness plan, pandemic preparedness checklist [ , ] and related themes from the literature [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] . pandemic preparedness 'experts' working with iom provided their feedback on the revised version and it was adjusted accordingly. it was then translated from english into thai using two independent translation services. each translation was subjected to review by one author (nj) and the one judged to be superior was blind backtranslated [ ] . the back-translation was compared to the original english version and necessary adjustments were made. mchws provided further feedback on the questionnaire during training sessions and revisions were made to ensure cultural appropriateness. the questionnaire was then piloted with non-study participants and revised one final time for clarity. interpretation of the thai questionnaire into the primary languages of the participants was rehearsed extensively during training to ensure accuracy and equivalency between mchws. the subset of results reported in this paper include, socio-demographic variables and measures to reduce risk of disease transmission. these data were collected using closed-ended questions. one to two days of data collection were observed in each province by one author (jh) to ensure quality and consistency of questionnaire administration. additionally, each data collector's first three interviews were audiorecorded and reviewed for consistency. mchws were required to review completed questionnaires for missing or unclear responses and to resolve these before leaving the participant's home. questionnaires were reviewed for completeness and logical data checks were made prior to computer data entry. questions arising were resolved with the mchw. the first questionnaires from each province that were entered by the data-entry clerk were reentered by one author (jh) in their entirety to assess for errors. if errors were discovered, feedback was given to the data-entry clerk and/or mchws, the error corrected, and the next records examined similarly. a % random sample of questionnaires was later re-entered to confirm data quality. univariate descriptive analyses were conducted and frequency tables were created using microsoft excel. questionnaires with incomplete response sets for this data subset (n = ) were omitted from analysis. data from both provinces were combined to provide a broad assessment of migrants' practices and perceptions that could be used by iom and the moph to implement policies and programs at a national level. the response category of 'unsure/declined to answer' was included as a valid response for the purposes of data analysis. previous work at iom has shown that this category of response is typically high among this population as migrants are careful to avoid giving answers that may be viewed negatively by health/governmental authorities. it is an important response item in terms of analysis because it helps us gauge migrant's uncertainty about the survey questions as well as their comfort level with participation. results were summarized within each category of npi. data collectors were able to enroll a volunteer from each household selected for sampling. a total of participants were included in analyses, from tak province and from chiang rai province. forty-nine percent were between to years of age. fifty-one percent were female. education levels were low, % having no formal education, and only % having completed more than six years. seventy-five percent were able to have at least a basic conversation in thai. over one in five were unemployed and of those employed, the most common job reported was daily labourer ( %). median family income was usd (thb ) per month and supported an average household of . family members (sd . , range - ). only % of participants responded that they would agree to stay inside their homes if sick with an influenza-like illness during an outbreak. the majority ( %) were unsure what action they would take or declined to answer the question. hospital ( %) was the preferred location for confinement, followed by the home ( %). one quarter of respondents had used face masks in the past when sick. slightly less ( %) said they would agree to use a face mask if sick in the future and over half ( %) said they would not wear a face mask. only one third believed that wearing a mask could prevent the transmission of illness. further results are presented in table . the majority of respondents ( %) said that if they were sick with an influenza-like illness they would agree to tell health authorities so that contacts could be located. most ( %) would feel more comfortable giving this information to a mchw. less than half ( %) reported that they would be able to check their own temperature at home; the most common barriers to doing so were not owning a thermometer ( %) and not knowing how ( %). participants were given a scenario in which they had been in contact with someone sick with influenza. in response, just over half ( %) would agree to take preventative medicine and avoid travelling to places with no signs of outbreak. when given a hypothetical of a disease outbreak or pandemic, nearly half ( %) said they would remain in their community. some said they would move to another community in thailand ( %) and a few said they would move back to their home country ( %). if official border crossings were closed, some participants would travel through other routes ( %). just under half of respondents ( %) agreed that banning cross-border travel during a pandemic could help prevent the spread of disease. further results are presented in table . respondents were asked whether they thought various social distancing measures would be effective at reducing the spread of illness during periods of disease outbreak. avoiding gatherings of five or more people received the most positive responses ( %), followed by avoiding places of entertainment ( %), avoiding department stores, supermarkets and minimarts ( %), avoiding restaurants ( %), limiting contact with family and friends ( %), avoiding public transportation ( %), keeping children from school ( %), avoiding the workplace ( %), avoiding the hospital ( %), and avoiding the public health centre ( %). further results are presented in table . less than half of all respondents ( %) said they would increase hand washing frequency during an outbreak or pandemic. among those who would increase hand washing % do not use any form of soap. less than half ( %) agreed that hand washing can reduce the transmission of illness during periods of disease outbreak. like hand washing, only % of those who would increase disinfection frequency during a pandemic ( %) would use some form of soap. further results are presented in table . the vast majority of respondents ( %) said they would agree to truthfully answer questions about their current health at a border crossing. more than nine in ten would truthfully tell health workers if they were feeling sick ( %) and allow health workers at the border to take their temperature ( %). most ( %) would agree not to cross the border if sick after leaving an area with disease outbreak. further results are presented in table . we conducted a cross-sectional survey among vulnerable migrants in northern thailand to gain a better understanding about their perceptions of, and ability to implement, various npis proposed by the who. with the exception of border measures, to which nearly all participants reported they would be adherent, attitudes towards recommended npis were generally negative or uncertain: measures to reduce risk that cases transmit infection would be implemented only by a minority; perceptions towards implementing measures to reduce the risk that contacts transmit infection were somewhat better, but still a cause concern; perceived efficacy of social distancing measures was low; and, less than half of participants thought that disinfection measures could reduce the spread of influenza during a pandemic. these results demonstrate the existence of potential barriers to npi implementation during a pandemic, suggesting that vulnerable migrants in thailand have a limited capacity to participate in pandemic preparedness efforts. in addition to negative perceptions towards npis, we also identified several other barriers: most had never worn a face mask before when sick, so are unlikely to know the correct way to do so if necessary in the future; many reported being unable to monitor their own temperatures, mainly due to not owning a thermometer and not knowing how to use a thermometer; and, most use clean water only for hand washing and disinfection, implying either a lack of knowledge about adequate disinfection or a lack of materials (e.g., soap or disinfectant). our results differ with those of lau et al. [ ] who found that . % of people surveyed in hong kong surveyed would comply with quarantine measures. only % and % of participants in this study would agree to home or hospital isolation, respectively. social distancing could be seen as another form of quarantine. results on social distancing in our study were somewhat comparable to a study of indians recruited from hospitals, factories, markets, and office in udaipur province, india [ ] . the authors found that the majority of participants did not adhere to the recommended social distancing measures. we did not measure behaviour, but the negative or uncertain attitudes in our sample suggest that adherence rates would be similar. not being able to go to work and not having access to basic necessities are two potential explanations why individuals would not want to be isolated [ ] . current results also differed from lau et al.'s [ ] sample on face mask use and hand washing. the authors comment that wearing masks is an "established practice in hong kong" (p. ), which might explain why the vast majority of participants had worn face masks in the past even though only about a quarter perceived them to be 'very effective'. a similar finding was noted for hand washing. perceptions were comparably low in our sample, but fewer participants agreed they would employ these measures. the one area where our results matched those of lau et al. [ ] was in peoples' willingness to tell border officials if they were feeling ill. nearly all participants from both studies agreed they would do so. we were unable to find any comparable literature related to other border measures, or about peoples' attitudes towards contact tracing. there is a need to educate vulnerable groups about npis during inter-pandemic and pandemic periods. the who technical consultation on public health measures during the influenza a (h n ) pandemic highlights the need for risk communication materials to be "adapted, tested and approved for local use ahead of time" ([ ], p. ). during the a (h n ) pandemic in thailand risk communication was undertaken through television, radio and printed materials. however, coordination of these efforts was not always well managed and messages were sometimes inconsistent and inaccurate [ ] . a better understanding about individuals' perceptions of npis could help to highlight areas in which public health officials should focus risk communication and other educational activities. ongoing risk communication should be used to increase local knowledge. public education campaigns have increased among migrants in thailand since the bird flu in , but knowledge levels remain low (hickey j, gagnon aj, jitthai n: knowledge about pandemic influenza preparedness among vulnerable migrants in thailand, submitted). the gap between public education efforts and results highlight the inherent challenges in bringing health education to vulnerable migrant populations. many of the migrants in this study live in remote, hard to access areas and belong to diverse cultural and linguistic groups. migrants may also have limited experience applying recommended guidelines [ ] and undocumented migrants may avoid contact with public health officials due to fear of deportation. for risk communication to be effective, it must address these challenges and incorporate a component designed to improve people's perceptions of npis. widespread implementation of npis will be unlikely if public perceptions remain low [ , ] . future research efforts should continue to assess the perceptions and ability of diverse populations relating to implementation of npis. these data could provide valuable information to public health agencies with regard to planning for future outbreaks and pandemics and assessing risk communication and public education activities. in the current inter-pandemic period, it would also be beneficial to develop and test measures to improve perceptions towards and understanding of npis, particularly among potentially vulnerable populations. ongoing efforts to systematically assess and standardize public education campaigns and risk communications for consistency and effect should also continue, as should the development of culturally and linguistically appropriate materials. this study has several limitations. translation of some concepts (e.g., pandemic) into migrant languages was sometimes difficult. this difficulty was addressed by working with mchws to determine acceptable translations. because this was a cross-sectional study with data collected at one time point only we were not able to measure potential changes in behaviour resulting from npi recommendations. as such we are not able to say with certainty that our results are associated with decreased capacity to enact npis, though based on the literature presented it seems likely that this would be the case. our results provide a baseline that may be useful in assessing future public education efforts. external validity in this study was reinforced by random sampling of households and high participation rates. validity may be threatened by our decision to request an individual volunteer from each randomly selected household. census data is not available for this population, but comparison with socio-demographic data from relevant studies [ , ] suggests that we obtained a representative sample. we were able to enroll a volunteer from each household that was sampled, but despite attempts to ensure completeness, participants had to be excluded from data analysis due to missing answers. internal validity was strengthened by the incorporation of existing questionnaires and concepts into an adapted tool, expert review of the adapted tool, rigorous translation, and extensive cultural review and pretesting of the final instrument. we did not conduct a factor analysis due to time/resource constraints. who pandemic guidance documents propose that individuals have a role to play in pandemic preparedness. however, if these individuals do not know how to fulfill that role or do not believe that certain interventions will be effective, they are unlikely to take part in the role that has been proscribed to them. results from the current study suggest that vulnerable migrants in thailand have a limited capacity to participate in pandemic preparedness efforts due to negative or uncertain attitudes towards npi effectiveness and an inability to enact certain npis. this limited capacity likely puts this population of migrants at risk for contracting and transmitting influenza during periods of outbreak and pandemic. current results highlight the need for ongoing, culturally-appropriate, multi-lingual risk communication and public health education. research into the appropriate use of risk communication during inter-pandemic and pandemic periods, combined with ongoing education at the community level, could potentially strengthen individuals' capacity to participate in pandemic preparedness efforts. world health organization: public health measures during the influenza a (h n ) oseltamivir resistance -disabling our influenza defences ministry of public health: the second national strategic plan for the prevention and control of avian influenza and preparedness for influenza pandemic. bangkok: ministry of public health pandemic preparedness among sudanese migrants in greater cairo. geneva: 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poultryhandling practices during avian influenza outbreak back-translation for cross-cultural research changes in knowledge, perceptions, preventive behaviours and psychological responses in the pre-community outbreak phase of the h n epidemic public knowledge, attitude and behavioural changes in an indian population during the influenza a (h n ) outbreak the community's attitude towards swine flu and pandemic influenza pandemic influenza preparedness and response among immigrants and refugees assessment of mobility and hiv vulnerability among myanmar migrant sex workers and factory workers in mae sot district. tak province, thailand: international organization for migration submit your next manuscript to biomed central and take full advantage of: • convenient online submission • thorough peer review • no space constraints or color figure charges • immediate publication on acceptance • inclusion in pubmed, cas, scopus and google scholar • research which is freely available for redistribution the authors declare that they have no competing interests.authors' contributions jh contributed to project development, led implementation, and was responsible for leading data analysis and manuscript publication. ag and nj contributed to project development, supported implementation, and guided data analysis and manuscript drafting. all authors read and approved the final manuscript. nigoon jitthai is the former employee of the international organization for migration (iom). key: cord- -tgbw ua authors: vardoulakis, sotiris; salmond, jennifer; krafft, thomas; morawska, lidia title: urban environmental health interventions towards the sustainable development goals date: - - journal: sci total environ doi: . /j.scitotenv. . sha: doc_id: cord_uid: tgbw ua abstract the aim of the un sustainable development goals (sdgs) is to achieve a better and more sustainable future for all by . since the majority of the global population lives in cities, it is crucial to identify, evaluate and implement urban interventions (such as such as zero carbon housing, active transport, better urban connectivity, air pollution control, clean household fuels, and protection from heat and flood events) that will improve health and wellbeing and make our natural and built environment more sustainable. this virtual special issue (vsi) comprises of diverse case studies, methods and tools that provide suggestions and interventions which directly or indirectly support the achievement of the un sdgs. the united nations agenda for sustainable development, and its sustainable development goals (sdgs) in particular, have focused the attention of researchers, practitioners and policy-makers on interventions that have the potential to provide multiple benefits ("co-benefits") for health, the environment, and the economy, particularly in urban settings were two-thirds of the world population will live by (un ) . progress towards the sdgs has being made in many areas, but, overall, action to meet the goals is not yet advancing at the speed or scale required to achieve their specific targets and bring about transformational change. in september , the un secretary-general called on all sectors of society to mobilize for a decade of action to accelerate sustainable solutions to the world's biggest challenges, ranging from poverty and gender to climate change, inequality and closing the finance gap (un ). many of these challenges are experienced in cities around the world, and particularly in rapidly urbanising low and middle-income countries, which face overpopulation, lack of adequate resources and infrastructure, climate change, urban heat islands, extreme weather, air pollution, and related illnesses, inequalities and productivity losses (salmond et al. ; vardoulakis et al. ; vardoulakis and kinney ) . at the same time, the complex links between the growing burden of non-communicable diseases (such as cancer, cardiovascular, respiratory, neurodegenerative and autoimmune diseases), urban form and environmental quality are becoming increasingly recognised. identifying and promoting effective urban environmental health interventions for addressing the sdgs, such as reducing carbon emissions (goal ), which can enhance good health and wellbeing (goal ), is urgent (howden-chapman et al. ) . well-planned, sustainable, changes to urban transport, housing, land use, renewable energy generation, and waste management have the potential to lead to improvements in air and water quality and liveability of urban environments providing multiple benefits including improved public health, reduced inequalities and higher productivity in cities . furthermore, the use of smart sensing technologies and mobile platforms, and the development of advanced techniques for the analysis of big data, when applied appropriately, can revolutionise environmental and public health management in cities (salmond et al. ) . citizen science, awareness raising and behaviour change campaigns are also expected to have an impact on environmental sustainability and urban health, although it is currently unclear whether benefits of such interventions can be sustained over time (bonney et al. ). the healthy-polis consortium for urban environmental health and sustainability (www.healthy-polis.org) aims to contribute to the implementation of the sdgs by identifying and evaluating specific policy initiatives, case studies, evidence gaps, and opportunities for research and translation into environmental public health practice in cities around the world. in this virtual special issue, we present a collection of such case studies from countries ( high income, and middle or low income countries; table ) and discuss their implications for achieving the sdgs (figure ). the research presented in this this virtual special issue, highlights a number of key interventions aimed at achieving the sdgs and their consequent pathways to health and environmental impact. one of the main direct effects of climate change is the increase in global average temperature, as well as in the frequency and severity of extreme weather events (e.g. heatwaves). this has a disproportionate impact on built up areas due to the urban heat island effect, housing overheating and overcrowding, and the vulnerability of the resident population (heaviside et al. ) . two of the studies included in the special issue focus on temperature related impacts on health and wellbeing due to the poor thermal performance of houses in brisbane, australia (asumadu-sakyi et al. ), and the mitigation strategies aiming to reduce radiant heat load on buildings in korea (park et al. ). one of the key challenges when attempting to address goal (health and wellbeing) is to improve both ambient and household air quality. xue et al. ( ) focused on satellite-derived air pollution (pm . ) as an evaluation index for health and wellbeing. in their paper, the temporal trends of pm . and the quantitative potential impact of environmental governance on pm . were analysed for china. using environmental regulation intensity and synergy to quantify the influence of governance, they concluded that regulatory measures should be enhanced to further decrease pm . in the future ( in a different context, adesina et al. ( ) assessed the impact of solid fuel burning in an indoor and ambient environment near coal-fired power plants in south africa using continuous monitoring of pm in two houses, of which only one used coal as a primary source of energy. they found significant differences in indoor air pollution levels during the winter season, but also at times high ambient concentrations, which indicated that decarbonisation of household energy and power generation could bring significant benefits for air quality and public health (adesina et al. ) . in a comprehensive analysis of cooking solutions in western africa, co-benefits of clean cooking solutions (goal , affordable and clean energy) at household level were analysed in relation to goals (health and wellbeing), (gender equality), and (climate action). interestingly, the most important co-benefit was related to gender equality (goal ), representing - % of the total economic benefit of the intervention (mazorra et al. ). carmichael et al. ( ) explored the use of public health research and evidence in policy to regulate new buildings in england to deliver improved public health, climate resilience and a reduced carbon footprint. they showed that public health evidence was hardly referenced in policy, and that a narrow focus on climate mitigation in building regulations results in both positive and negative impacts on health. this highlights the need for a systems approach around urban interventions (carmichael et al. ). human vulnerability assessment is an important tool within the scope of goal (climate action), as it can help develop adaptation strategies in the context of regional climate change. vommaro et al. ( ) demonstrated the application of a modelling method to evaluate human vulnerability to climate change in the state of maranhão, brazil. using a municipal vulnerability index based on socioeconomic, demographic, climate, epidemiological, and environmental aspects, they identified the most vulnerable areas under climate change (vommaro et al. ). wu et al. ( ) identified good practice and lessons learned from china's response to severe flooding in anhui province in . good practice included using early warning systems to advise communities of risks and enforce evacuation in the flood zone, preparing and using schools as shelters with open-ended periods of operation, and providing stable shelter accommodations with medical and public health services, clean drinking water and food, sanitation, and toilet hygiene through multiagency cooperation. they concluded that disaster mitigation strategies needs to be integrated with climate adaptation plans in cities (wu et al. ) . two studies from new zealand focused on active transport (macmillan et al. ) , and on integrated urban planning and regeneration (howden-chapman et al. ) . macmillan et al. ( ) used an active transport case study from auckland to illustrate the complex causal pathways that contribute to achieving several sdgs, including goal (sustainable cities) and goal (reduced inequalities there is limited evidence in research, policies and in the sdgs about the impact of environmental factors on non-communicable diseases (ncds) in urban areas of sub-saharan africa, although % of ncds are taking place in low-and middle-income countries and are linked to a third of the deaths in sub-saharan africa. rother ( ) poses the question: what would these statistics look like if environmental risk factors (e.g., pollution, climate change) were prevented and controlled. rother ( ) presents a framework for understanding climatic impacts on climate-sensitive ncds and achieving the sdgs. this explains how current global mitigation interventions in high income urban settings, with implied health co-benefits for ncd reduction (i.e. use of less polluting vehicles, cycling, walking, public transport, green spaces), experience major implementation challenges in sub-saharan african cities (i.e. too costly, lack of availability, poor road conditions, gender and cultural norms, security problems). the article recommends more support for research on the climate-ncd nexus, ensuring health professional training includes sustainable health education, and including a focus on climate change and health in primary and secondary school curricula (rother ) . in the decade of action for sdg implementation (un ), the recovery pathways from covid- are an opportunity for governments, urban planners, environmental public health practitioners, and other stakeholders to build back better our cities (wri ). the healthy-polis vsi: urban environmental health interventions towards the sustainable development goals provides diverse evidence, case studies and tools to inspire action in cities and regions around the world, so they can emerge healthier and more sustainable future post covid- . the interventions and tools discussed can be used to provide multiple environmental health solutions, which are context specific. for this reason, it is important to consider the intended and unintended consequences of these interventions by using a cross-disciplinary systems approach and involving all relevant stakeholders in discussions and decision making. promoting climatesensitive urban policies, such as zero carbon housing, active transport, better urban connectivity, clean household fuels, and protection from heat and flood events, will help improve health and wellbeing in cities as we move towards achieving and sustaining the sdgs. contrasting indoor and ambient particulate matter concentrations and thermal comfort in coal and non-coal burning households at south africa highveld seasonal temperature patterns and durations of acceptable temperature range in houses in brisbane, australia can citizen science enhance public understanding of science? healthy buildings for a healthy city: is the public health evidence base informing current building policies? the urban heat island: implications for health in a changing environment evaluating natural experiments to measure the co-benefits of urban policy interventions to reduce carbon emissions in new zealand verification of a bioclimatic modeling system in a growing suburb in melbourne suburb-level changes for active transport to meet the sdgs: causal theory and a new zealand case study integrating four radiant heat load mitigation strategies is an efficient intervention to improve human health in urban environments controlling and preventing climate-sensitive noncommunicable diseases in urban subsaharan africa towards the integrated study of urban climate, air pollution, and public health can big data tame a "naughty" world? the canadian geographer microenv: a microsimulation model for quantifying the impacts of environmental policies on population health and health inequalities sustainable development goals decade of action challenges and opportunities for urban environmental health and sustainability: the healthy-polis initiative local action on outdoor air pollution to improve public health grand challenges in sustainable cities and health contributions of municipal vulnerability map of the population of the state of maranhão (brazil) to the sustainable development goals after the crisis: how covid- can drive transformational change in cities planned sheltering as an adaptation strategy to climate change: lessons learned from the severe flooding in anhui province of china in satellite-derived spatiotemporal pm . concentrations and variations from to in china simulation analysis of natural lighting of residential buildings in xi'an, china we acknowledge in-kind contributions and support from the healthy-polis international consortium for urban environmental health and sustainability. key: cord- -civfvk authors: su, tong; han, xue; chen, fei; du, yan; zhang, hongwei; yin, jianhua; tan, xiaojie; chang, wenjun; ding, yibo; han, yifang; cao, guangwen title: knowledge levels and training needs of disaster medicine among health professionals, medical students, and local residents in shanghai, china date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: civfvk background: disaster is a serious public health issue. health professionals and community residents are main players in disaster responses but their knowledge levels of disaster medicine are not readily available. this study aimed to evaluate knowledge levels and training needs of disaster medicine among potential disaster responders and presented a necessity to popularize disaster medicine education. methods: a self-reporting questionnaire survey on knowledge level and training needs of disaster medicine was conducted in shanghai, china, in . a total of randomly selected health professionals, medical students, and , local residents provided intact information. the total response rate was . %. results: overall, . % of these participants have received systematic disaster medicine training. news media ( . %) was the most common channel to acquire disaster medicine knowledge. although health professionals were more knowledgeable than community residents, their knowledge structure of disaster medicine was not intact. medical teachers were more knowledgeable than medical practitioners and health administrators (p = . ). clinicians performed better than public health physicians (p< . ), whereas public health students performed better than clinical medical students (p< . ). in community residents, education background significantly affected the knowledge level on disaster medicine (p< . ). training needs of disaster medicine were generally high among the surveyed. ‘lecture’ and ‘practical training’ were preferred teaching methods. the selected key and interested contents on disaster medicine training were similar between health professionals and medical students, while the priorities chosen by local residents were quite different from health professionals and medical students (p< . ). conclusions: traditional clinical-oriented medical education might lead to a huge gap between the knowledge level on disaster medicine and the current needs of disaster preparedness. continuing medical education and public education plans on disaster medicine via media should be practice-oriented, and selectively applied to different populations and take the knowledge levels and training needs into consideration. over the past decade, the intensity and frequency of natural and man-made disasters have been noticeably increasing all over the world. hurricane, earthquake, flood, outbreaks of infectious diseases, nuclear leakage, oil spills, and other disasters in recent years have caused huge economic losses, serious environmental disruption and lasting psychological impairment to the survivors [ ] [ ] [ ] [ ] [ ] . community residents are the very ones directly affected by disasters. therefore, self-rescue and mutual-aid are essential to form the first defense line. disaster relief and assistance are mainly carried out by medical rescue teams, which are constituted of health professionals from on-call health agencies such as military medical systems and centers for disease control and prevention (cdc) [ ] . hence, community residents and health professionals as the key components of first responders should be sufficiently trained to perform timely and effective medical rescue [ ] . disaster medicine training, an integrated part of efficient disaster preparedness, is vital for community residents to perform timely self-rescue and mutual-aid and also for health professionals to develop comprehensive skills [ ] . since the ' . terrorist attack, many countries have put emphasis on disaster medicine training and have sponsored various researches focusing on a wide range of disaster medicine, including description and assessment of the current disaster medicine training programs in order to improve the efficiency of disaster rescue. however, these researches on disaster medicine have mainly been conducted in developed countries, while data from developing countries are scarce [ ] [ ] [ ] [ ] [ ] [ ] . from a global perspective, disaster frequently attacks developing countries with weak public health infrastructure and often results in severe consequences. in china, the severe acute respiratory syndrome (sars) in - resulted in , cases and deaths [ ] . the devastating earthquake in sichuan, china, in caused more than , deaths, , missing and , wounded persons [ ] . however, disaster medicine has not been included either in the undergraduate curriculum of medical schools or in the continuing medical education in china. in the past decades, chinese medical education system has experienced flexuous reforms [ ] [ ] [ ] . traditional medical education and assessment criteria have been largely clinically oriented, while disaster medicine has been long neglected [ ] . recently, efforts have been made to implement disaster medicine education in china. the current program of disaster medicine education focuses on developing particular small scale training programs, such as short-term training course of disaster nursing for undergraduates, psychosocial training program for mental health workers, and emergency preparedness training program for public health staff [ ] [ ] [ ] [ ] . however, current knowledge status and training needs of main players on disaster medicine were unknown. to the best of our knowledge, only one study surveyed the disaster medicine education needs of health professionals who participated in the earthquake rescue, but their related knowledge was not evaluated [ ] . in this study, we evaluated the knowledge levels and training needs in populations that are most likely to be involved in disaster rescue. these data are essential in developing proper medical training programs of disaster medicine. three groups of participants in shanghai, china, were enrolled in this cross-sectional epidemiological study: health professionals, medical students, and community residents. a stratified cluster random sampling strategy was used to select health professionals and medical students. a total of health professionals were composed of medical practitioners, medical teachers, and health administrators. the medical practitioners were clinicians, public health physicians, nurses, and medical technicians from two comprehensive tertiary hospitals and three cdcs. the medical teachers and medical students were selected from medical schools. health administrators were from the municipal health bureau and district health bureaus. a multi-stage sampling method was used to select , community residents. we first randomly selected communities in the yangpu district. in each community, we randomly selected , , , , and residents ( residents per community) at the age of , years, - years, - years, - years, - years and . years, respectively, according to the census data of age composition in shanghai. a structured questionnaire for health professionals/medical students was designed by three investigators (ts, hz, and gc) based on the university examination data bank of emergency medicine, preventive medicine, and health management, as well as published literatures [ , ] . after two rounds of discussion among the investigators and three rounds of discussion with external experts, final version of the questionnaire was made of three sections. the first section included demographic information such as age, gender, educational level, medical profession, and disaster rescue experience. the second section contained multiple-choice questions (q -q ) as a knowledge test covering various aspects of disaster medicine. in this section, participants could get one score for each correctly answered question and zero for an incorrect answer. the full score was . the third section had multiple-choice questions regarding the training needs of disaster medicine. the first questionnaire is presented as questionnaire s . based on this questionnaire, we designed the second questionnaire for community residents (questionnaire s ). the second questionnaire had multiple-choice questions (q -q ) as a knowledge test. eight questions were included in both questionnaires due to their importance in disaster medicine (table s ) . before each survey, trained research assistants would give detailed instructions. the participants were then asked to finish the questionnaire independently. informed consent was initially distributed to every candidate study subjects to help them make a fully voluntary decision on participating or declining. participants who provided their written informed consent were included in this study. the study protocol conformed to the declaration of helsinki and was approved by the ethics committee of second military medical university. descriptive statistics were conducted for demographic characteristics. differences in categorical variables were determined using the chi-square test. analysis of variance (anova) was used to compare the total scores on average among different participants. student-newman-keuls (snk) test was used to correct for multiple comparisons. multivariate linear regression was used to analyze the factors contributing independently to the knowledge score. a beta coefficient was calculated to indicate the effect of each independent variable on the score. all tests were two-sided and conducted using spss version . (spss, chicago, il). a p value of , . was defined as statistically significant. a total of ( . %) health professionals, ( . %) medical students, and , ( . %) community residents provided complete information. of the , participants, , ( . %) were men and , ( . %) were younger than years. table shows the demographic characteristics. most of the health professionals had a bachelor's degree or higher in contrast to community residents ( . % vs. . %). health professionals were composed of ( . %) medical practitioners, ( . %) medical teachers, and ( . %) health administrators. of the medical practitioners, were clinicians, were public health physicians, were nurses and the remaining were medical technicians. the professional titles of health professionals were research assistant ( . %), senior research assistant ( . %), assistant professor ( . %), associate professor ( . %), and full professor ( . %). of medical students, ( . %) majored in clinical medicine and ( . %) majored in public health. among community residents, . % had no stable employment or retired. of all participants, ( . %) had disaster relief experience and ( . %) had ever received systematic training of disaster medicine. for all , participants, most of them ( . %) had low or moderate self-estimated knowledge concerning disaster medicine, and media (newspaper, magazine, internet, and tv/radio) was the most common channel to acquire knowledge on disaster medicine. table depicts the correct answer rates to the questions (q -q ) in the knowledge test using the first questionnaire. the questions were correctly answered by . % of the professionals and students except q , q , and q . average total score of the knowledge test was . ( % ci = . - . ) for health professionals and . ( . - . ) for medical students (p = . ) ( figure a ). although the score of the two populations was not significantly different, there were significant differences in correctly answering individual questions: q , q , q , q , and q ( figure a ). in health professionals, the score was . ( . - . ), . ( . - . ), and . ( . - . ) for medical practitioners, medical teachers, and health administrators, respectively (p = . for the comparison of three groups) ( figure b ). for pairwise comparison, snk test showed that medical teachers' average score was significantly higher than medical practitioners' (p = . ) and health administrators' (p = . ), while there was no statistically significant difference between medical practitioners and health administrators (p. . ). the rates of correctly answering questions (q , q , q , q , q , q , q , q , and q ) were significantly different among medical practitioners, medical teachers, and health administrators (p, . ) ( table ) . for example, in answering q , medical teachers did better than medical practitioners (p = . ) and health administrators (p, . ). moreover, the knowledge level was also significantly different among clinicians, public health physicians, nurses, and medical technicians, especially in correctly answering questions (table s ) . clinicians performed better than public health physicians (p, . ) ( figure s ). in medical students, the score in public health students ( . , % ci = . - . ) was higher than that in clinical medicine students ( . , . - . ) (p, . ) ( figure c ). the rates of correctly answering questions (q , q , q , q , q , q , q , and q ) were significantly different between the students of majors (p, . ) ( table ) . table shows the rate of right responses to the questions (q -q ) in community residents. the questions were correctly answered by . % of community residents except q and q . after stratified by educational level, the score of well-educated (bachelor or higher) group ( . , . - . ) was significantly higher than that of poor-educated (junior college or lower) group ( . , . - . ) (p, . ) ( figure d ). the rates of correct answers to questions (q , q , q , q , q , q , and q ) were significantly different between the two groups (p, . ). we compared the rates of correctly answering the common questions in both questionnaires (table s ) between health professionals and community residents. the rates were generally figure . comparison of the total score on average of disaster medicine knowledge test. a. health professionals and medical students: no significant difference (p = . ); b. three groups of health professionals: total score on average of medical teachers was significantly higher than that of medical practitioners (p = . ) and health administrators (p = . ); c. medical students of two majors: total score on average of public health students was significantly higher than clinical medicine students (p, . ). d. community residents of different educational levels: total score on average of those with high education background was significantly higher than those without (p, . ). doi: . /journal.pone. .g lower in community residents than in health professionals ( . % vs. . %) except q ( figure b ). multivariate linear regression analysis indicated that educational level (b = . , p, . ) and professional title (b = . , p = . ) were significantly associated with an increased knowledge score, whereas age was inversely related to the score (b = . , p, . ), in health professionals. educational level was the unique factor significantly associated with an increased score in community residents (b = . , p = . ). public health major was the factor significantly associated with an increased score in medical students (b = . , p = . ). a. health professionals vs. medical students: p, . for q 'self-rescue measures in an earthquake', q 'triage and treatment priority', q 'concept of first aid abc', q 'tourniquet hemostasis', and q 'skills of psychological assistance in post-disaster relief'; b. health professionals vs. community residents: p, . for q 'cardiopulmonary resuscitation procedure', q 'difference between remote and urban rescue', q 'self-rescue measures in an earthquake', q 'location of temporary toilets during disaster rescue', q 'skills of psychological assistance in post-disaster relief', and q 'epidemic prevention strategies after a disaster' and p, . for q 'fracture fixation and transport' and q 'self-rescue measures in a high-rise fire'. doi: . /journal.pone. .g table depicts the training needs of health professionals and medical students. the overall opinions on teaching method, course arrangement, and teaching material were consistent among the two groups. more than half of these participants selected 'lecture', 'practical training', and 'disaster movies or videos' as preferred teaching methods. most participants chose 'required course for public health professional' as the major training course, and preferred using 'national unified textbook' as standard teaching material. however, medical teachers considered that 'practical training' and 'disaster movies or videos' were not appropriate for teaching disaster medicine, in contrast to medical practitioners and health administrators. most health administrators believed that disaster medicine training should be a required training subject not only for public health professionals but also for clinicians. table shows disaster medicine training needs of community residents. the majority ( . %) selected 'need to learn disaster medicine' and 'need of disaster medicine course for children'. about half of community residents selected 'lecture' and 'practical training' as preferred teaching methods. more than % of community residents selected 'willing to participate in disaster simulation drill regularly' and believed that 'community volunteer team for disaster relief should be set up and willing to participate volunteer team'. compared to community residents with lower educational level, those with higher education background considered that 'systemic study' was more appropriate for teaching ( . % vs. . %, p, . ). figure presents the key contents concerning disaster medicine training prioritized by health professionals, medical students, and community residents. more than % of health professionals and medical students selected the contents of 'first aid skills', 'epidemic prevention and control', 'psychological problems in post-disaster relief', and 'principles of disaster disposal' as important contents; while most community residents chose 'first aid skills' and 'basic concepts of disaster medicine' as important contents. significant differences existed among subgroups within each group of participants. for example, compared to medical practitioners, medical teachers considered that 'triage and evacuation' was less important ( . % vs. . %, p = . ) (table s ) . twenty-five items covering most aspects of disaster medicine were provided for the selection of interested training contents (table s ). figure presents the most interested contents of disaster medicine training prioritized by health professionals, medical students, and community residents. health professionals selected 'basic principles of disaster rescue' ( . %), 'treatment principles and first-aid skills' ( . %), and 'psychological relief' ( . %) as the most interested contents, while community residents selected 'basic principles of disaster rescue' ( . %) and specific disaster events such as 'earthquakes' ( . %) and 'fire disaster' ( . %). in this study, we evaluated the current knowledge levels and training needs of disaster medicine among health professionals, medical students, and community residents in shanghai, china. in general, our results reflected a high vulnerability of our populations when facing disaster. the knowledge level of disaster medicine was not satisfactory in health professionals except medical teachers. although the majority of the health professionals received formal medical education, few of them have ever received systematic training of disaster medicine (table ) . for health professionals and medical students, less accurate responses to q , q , and q (table ) indicate the low levels of knowledge on disaster psychology and disaster administration. the two components have been long neglected and should be added to disaster medicine training and specially addressed to these involved in psychological relief and administrative tasks. lack of knowledge regarding ptsd is an issue needs to be particularly addressed. because of the cultural perception in the chinese society, psychological health hasn't been widely accepted as a critical component in traditional medical and public health education. even though there is a rising awareness of its indispensible importance in recent years [ ] , relevant educational program and public health campaign are still lagging behind. in health professionals, the significant differences among different professions ( figure ) were mainly presented in their answers to the questions covering aspects: self-help and first-aid skills, triage and evacuation, psychological relief, and population vulnerability assessment. health administrators did not show their proficiency in disaster administration and disaster rescue organization, for they poorly answered the related questions such as q . leadership training programs could effectively improve the emergencyhandling capability of health administrators who might be involved in disaster rescue [ , ] . moreover, there were significant differences in knowledge levels among specialties (clinicians, public health physicians, nurses, and medical technicians) of medical practitioners. clinicians showed higher knowl- table . training needs of community residents and their differences between the educational level groups (number, %). edge level than other specialties, even on the aspect of epidemic prevention and control (table s and figure s ), which is one of the major tasks of public health physicians. the differences in the knowledge level indicate that the medical education in china had been largely clinically oriented; and little attention has been paid to public health preparedness, especially disaster preparedness. future training plans should clearly define the roles of public health physicians and health administrators in disaster rescue and enhance their capabilities to meet up-to-date requirements [ ] . the main reason of the lack of disaster medicine knowledge for health professionals might be that disaster medicine has rarely been included in medical school curriculum and continuing medical education, and no appropriate public health programs focusing on disaster preparedness. surprisingly, public health students showed a higher knowledge level than clinical medicine students (p, . ) ( figure c ). after the sars outbreak, the importance of public health preparedness has been emphasized with a curriculum restructure for public health major students. in addition to the traditional courses such as epidemiology, training programs for public health preparedness such as health management has been added as the main courses for public health major in some medical schools. however, disaster medicine is being developed as a training course in only a couple of medical schools in china. our results indicate that future public health physicians are expected to perform better in disaster rescue. interestingly, the knowledge level of health professionals was inversely related to age, which is in contrast to the general belief that older professionals have more experiences and therefore more knowledgeable. one possible explanation is that the young are more likely to have frequent access to modern media such as the internet and thus gain 'exposure' to updated information on disaster medicine. community residents displayed very poor knowledge and skills of disaster medicine. not surprisingly, community residents generally lacked specialty knowledge such as 'cardiopulmonary resuscitation procedure' and 'difference between remote and urban rescue' (table and figure b ). an important finding is that community residents with higher education background had higher knowledge level of disaster medicine than those without ( figure d ). thus, it is urgent to tailor community training programs for the residents with different education background and popularize disaster medicine education via modern media. this study also pointed out the training needs of disaster medicine. most participants selected 'lecture' and 'practical training' as preferred teaching methods. most health professionals and medical students suggested that disaster medicine should be a 'required course for public health professional' and asked for a 'national unified textbook' as standardized teaching material. most community residents believed 'need to learn disaster medicine' and 'need of disaster medicine course for children', and selected 'willing to participate in disaster simulation drill regularly' and 'community volunteer team for disaster relief should be set up, and willing to participate volunteer team' (table , table ). these results indicate that the training needs of disaster medicine is very high in chinese society and disaster medicine trainings should be executed as indispensable courses for health professionals, medical students, and community residents. meanwhile, the three groups of participants selected some different key and interested contents for disaster medicine training (figure and figure ). this reflects that distinct perception of disaster determines the different needs of disaster medicine training in different populations. similar differences in several items of the training needs were also presented among the subgroups of study participants. training programs such as disaster simulation and disaster exercise have proven to be effective and can rapidly deliver core elements of disaster medicine and improve the knowledge level and ability of disaster response [ , , ] . therefore, future continuing disaster medicine education should focus on developing practice-oriented and core elements-highlighted training courses. except the high-level interests in 'basic principles of disaster relief', there were some differences of interested contents among different populations, indicating future training program design should consider both core elements and interests, and customize to different needs. as medical teachers were more knowledgeable in disaster medicine than other populations surveyed ( figure b) , they should play a leading role in disaster medicine training. based on these data, we suggest a diagram flow of disaster medicine training as the shanghai model in figure s . the present survey was conducted in shanghai, one of the areas with well developed economy and affluent medical resources in china. after further evaluation, the shanghai model of disaster medicine training suggested in this study should be validated and generalizable to other developing areas where the problem of unmatched economic development and disaster medicine education also exist. these data also provide useful evidence to help developing disaster medicine training plans in other developing world. the current study had limitations. our community participants were from one district (yangpu) in shanghai chosen by cluster sampling. sample sizes may influence results if comparing subgroups within clusters. furthermore, other groups of disaster first responders such as firefighters and military personnel were not included in the current survey. future studies focusing on these special groups will provide valuable information for disaster preparedness. in conclusion, this large epidemiological study provided important data concerning knowledge level and training needs among the populations that would be involved in disaster rescue or affected by disasters. from a health education perspective, disaster training programs are urgently needed, with specific emphasis on certain contents, such as psychological relief and administrative skills. our study enables a more comprehensive evaluation of current disaster preparedness situation and facilitates designing future disaster medicine training programs in china and other developing countries. figure s comparisons of the total scores on average and rates of correctly answering important questions among clinicians, public health physicians, nurses, and medical technicians. a. comparison of average scores; b. comparison of correct answer rates. (tif) figure s suggested diagram of disaster medicine training (shanghai model). table s list of the same questions in two questionnaires. (doc) questionnaire s questionnaire for health professionals and medical students. questionnaire s questionnaire for community residents. (doc) mental health problems among the survivors in the hard-hit areas of the yushu earthquake resilience in the face of disaster: prevalence and longitudinal course of mental disorders following hurricane ike relationships between traumatic symptoms and environmental damage conditions among children months after the japan earthquake and tsunami impact of the deepwater horizon oil spill on a deep-water coral community in the gulf of mexico incidences, types, and influencing factors of snow disaster-associated injuries in ningbo, china how china responded to the may earthquake during the emergency and rescue period disaster medicine training in family medicine: a review of the evidence healthcare worker competencies for disaster training factors influencing collaborative activities between non-professional disaster volunteers and victims of earthquake disasters disaster : a novel approach to disaster medicine training for health professionals perspectives of future physicians on disaster medicine and public health preparedness: challenges of building a capable and sustainable auxiliary medical workforce medical student disaster medicine education: the development of an educational resource a disaster medicine curriculum for medical students european survey on training objectives in disaster medicine the sars epidemic in mainland china: bringing together all epidemiological data analysis of injuries and treatment of , inpatients in wenchuan earthquake-based on chinese trauma databank current perspectives on medical education in china medical education in china for the st century medical education and medical education research and development activities in modern china need for continual education about disaster medicine for health professionals in china-a pilot study development and evaluation of an undergraduate training course for developing international council of nurses disaster nursing competencies in china pilot training program for developing disaster nursing competencies among undergraduate students in china china-australia training on psychosocial crisis intervention: response to the earthquake disaster in sichuan evaluating the effectiveness of an emergency preparedness training programme for public health staff in china development and evaluation of a leadership training program for public health emergency response: results from a chinese study does leadership training make a difference? the cdc/uc public health leadership institute: - an estimation of canada's public health physician workforce a simulation-based biodefense and disaster preparedness curriculum for internal medicine residents what a disaster?! assessing utility of simulated disaster exercise and educational process for improving hospital preparedness key: cord- - zg j x authors: boufkhed, sabah; namisango, eve; luyirika, emmanuel; sleeman, katherine e.; costantini, massimo; peruselli, carlo; normand, charles; higginson, irene j.; harding, richard title: preparedness of african palliative care services to respond to the covid- pandemic: a rapid assessment date: - - journal: j pain symptom manage doi: . /j.jpainsymman. . . sha: doc_id: cord_uid: zg j x context: palliative care is an essential component of the covid- pandemic response, but is overlooked in national and international preparedness plans. the preparedness and capacity of african palliative care services to respond to covid- is unknown. objective: to evaluate the preparedness and capacity of african palliative care services to respond to the covid- pandemic. methods: we developed, piloted and conducted a cross-sectional online survey guided by the international health regulations. it was emailed to the african palliative care association's members and partners. descriptive analyses were conducted. results: eighty-three participants from countries completed the survey. most services had at least one procedure for the case management of covid- or another infectious disease ( %). respondents reported concerns over accessing running water, soap and disinfectant products ( %, %, and % respectively), and security concerns for themselves or their staff ( %). two in five services ( %) did not have any or make available additional personal protective equipment. most services ( %) reported having the capacity to use technology instead of face-to-face appointment, and half ( %) reported having palliative care protocols for symptom management and psychological support that could be shared with non-specialist staff in other healthcare settings. conclusion: our survey suggests that african palliative care services could support the wider health system’s response to the covid- pandemic with greater resources such as basic infection control materials. it identified specific and systemic weaknesses impeding their preparedness to respond to outbreaks. the findings call for urgent measures to ensure staff and patient safety. risk factors for severe illness and mortality in covid- include being elderly, the presence of pre-existing health problems, and multi-morbidities. ( ) ( ) ( ) race and ethnicity are also associated with higher incidence and poor prognosis. ( , ) on the african continent, prevalent co-morbidities such as hiv and tuberculosis pose a higher risk of mortality for patients with covid- . patients with moderate to severe forms of the disease and distressing symptoms such as breathlessness may require intensive care, which is poorly available within weak health systems.( ) , ( ) case management of covid- must include palliative care to relieve suffering, improve outcomes and save costs. ( , ) this is especially true in resource-limited settings, where palliative care teams are supporting complex decision-making for patients with severe covid- .( ) early evidence of needs among covid- patients referred to palliative care include distressing physical symptoms such as fever, breathlessness, fatigue, cough; ( , ) spiritual or existential distress caused by the threat to survival, and psychological distress among patients and families associated with clinical uncertainty. ( ) palliative care is an essential health service within universal health coverage goals. however, serious health-related suffering due to neglect of palliative care in global health disproportionately affects african countries. ( ) ( ) ( ) the international health regulations requires countries to develop and implement preparedness and response plans in case of public health threats of international concern( ). in a pandemic, the need for palliative care is amplified( ) but has been overlooked in preparedness and response plans to public health emergencies and humanitarian crises. ( , ) this results in a failure to protect highly vulnerable populations from unnecessary suffering. prior evidence shows palliative care's key role in pandemics to integrate protocols for symptom management, train non-specialists, support triage, and provide psychosocial and bereavement care. ( ) j o u r n a l p r e -p r o o f a world health organization assessment of covid- readiness showed moderate preparedness for % of the participating african countries.( ) as with other preparedness assessments, palliative care was not included. ( ) an appraisal of covid- case management guidelines in africa found that only eight countries had identifiable palliative care components. ( ) palliative care services are well placed to support health systems in caring for patients and families facing clinical uncertainty, assist complex decision making, and avoid unnecessary suffering. however, there is limited evidence of their preparedness to respond to a pandemic. this study aimed to evaluate the preparedness and capacity of palliative care services in africa to respond to the covid- pandemic. the survey questionnaire was originally designed by researchers from italy and uk for an assessment of the italian palliative care situation early in the epidemic. ( ) of palliative care services invited to participate, completed the survey at least partially (participation rate: %). we excluded due to missing data, and conducted analysis on data from respondents in countries (completion rate for those invited to participate: %). of these, four questionnaires were completed using a word version. none chose to participate by telephone. table presents the characteristics of participating services. the majority were non-profit charity or public, and half were hospital-based. these services provided care for a median of patients per year (iqr: - ). a third of services reported having at least one probable, suspected or confirmed case of covid- with a median of . overall cases (iqr: - · ). half of cases concerned a patient, with the remaining cases among patients' relatives or service staff (details in additional file ). respondents perceived high levels of anxiety and worry among service staff regarding the effects of covid- (see table ). staff were perceived to be highly anxious about being infected themselves (on a - likert scale, median: , iqr: - ) and worried about potential issues for their interaction with the community if the service is known to manage a potential covid- case (on a - likert scale, median: , iqr: - ). about one-third reported a perceived increase in staff absenteeism. j o u r n a l p r e -p r o o f half of respondents reported security concerns for themselves or their staff. these included socio- economic concerns such as loss of employment and livelihood, and fear of civil unrest related to the lockdown enforcement (e.g. curfew and police involvement in enforcement and staff's exposure to infection at work, in their home communities, or during their commute to work). table describes the procedures and policies in place, and their modifications in relation to covid- case management. three in five services had a case definition for covid- ( %), and at least one written procedure for covid- case management or for another infectious disease such as tuberculosis, hiv or ebola. four in five services had at least one written service procedure specific to covid- . the majority of palliative care services had modified at least one existing policy or procedure, mostly regarding visitors or relatives. with respect to staff support and training, less than half of respondents reported having a procedure to support healthcare providers to manage stress. one in five did not provide recommendations for situations of staff member (or someone in their household) becoming ill with covid- . forty-one respondents gave comments on procedures for staff stress, and most of these included having a staff support program available, counselling ( %) or discussions in team meetings ( %). two in five reported that not all healthcare providers have been trained in handling highly infectious conditions such as covid. of the services reporting such training, half had been trained prior to the pandemic, and half in response to covid- . three in five palliative care services declared that cleaning staff were included in information sharing and training regarding managing covid- . all but one service had put in place at least one measure to avoid contagion in their service. additional handwashing facilities were introduced in the vast majority of services ( %). however, two in five did not have any or make available additional personal protective equipment for clinical staff ( %), and cleaning staff ( %). fifty-seven respondents provided details on the ppe available, and revealed that the ppe is not always complete. they mainly reported having access to masks ( %) and gloves ( %). out of services having inpatient or managing patients in hospital beds, reported having identified an isolation room for covid- cases ( %). table presents the mechanisms in place to receive information if there is a confirmed or suspected case in the service or surrounding community. respondents stated that they would receive information from the local hospital or health centre, the facility or hospital, the covid- task team or rapid response team and/or the ministry or department of health. the head of nursing or palliative care, person in charge or project manager and/or hospital or facility management or health services coordinator were identified as recipients of this information. one in four respondents reported either no designated focal point identified in the service as responsible for collecting and sharing up-to-date information, or being unsure of who that person is. communication reliant on mobile phones could be used to disseminate covid- or other urgent information with staff, patients, visitors or relatives. the most reported means to share information with staff were whatsapp/viber ( %) and phone calls ( %); phone calls with patients ( %) and relatives or visitors ( %). about one in five services reported having no communication means for sharing information with patients ( %) or relatives ( %). other means included face-to-face communications, posters or noticeboards in the facility or hospital, radio or other media. respondents identified a lack of mobile phones or airtime to communicate with patients. table describes the information systems available to palliative care services for contact tracing and investigation. almost all services had up-to-date lists of staff and patients, and records of patients' symptoms and outcomes . most of the information systems were paper-based. however, half did not have up-to-date lists of relatives that have visited and did not record their visit dates. table describes the concerns regarding access to basic resources for infection control, and highlight respondents' concerns over essentials like accessing running water, soap and disinfectants products for the service and the community . a third of respondents reported not having, or not being sure of having, adequate material and facilities to dispose of highly infectious waste within the service (respectively % and %), especially in the community ( % and % respectively for the services delivering community care). most services had up-to-date inventories of medicines and medical supplies ( %) and of protective materials for staff, patients and visitors ( %). most services ( %) reported having capacity to use technology instead of face-to-face appointments to provide remote care, % could use phone calls. half of the services knew how to access additional staff in case of emergency, lockdown or quarantine ( %); three-fifth how to access medicines and other medical supplies ( %); and less than half of the services providing inpatient or hospital-based services knew how to access food ( %). fifty-four services had education material available ( %). of these, most were available for the surrounding community ( %) and almost all displayed posters displayed where staff, patients and visitors can see them ( %). half of services reported having palliative care protocols for symptom management and psychological support that could be shared with non-specialist staff in other healthcare facilities (see table ). of these services, all but three had the capacity to train non-specialists in using these protocols. three in four services reported having plans to support other healthcare services in the triage of patients in case of covid- outbreak. twelve respondents specified these plans, which included support in screenings, advanced care planning with newly admitted hospital patients, care of the dying, and beds supply due to service closure. half of the services ( %) reported having a plan to redeploy healthcare providers, volunteers or resources outside of inpatient settings, in case of outbreak. forty-four respondents reported limitations in their ability to share expertise. they included mostly financial concerns related to the lack of funding and cost of communication, as well as a lack of resources for training (including human resources). palliative care services on the african continent have put in place several measures to prepare and respond to covid- , but are limited by a lack of resources and the wider context within which they operate. the participating services had adapted their policies and procedures. they reported existing data collection and communication systems, and had the capacity to use technology to provide care remotely, mostly relying on mobile phones which could help prevent the spread of covid- . those with existing symptoms management and psychosocial support protocols are ready to train non-specialist in using them. the sharing of these skills is essential to meet potential population-level of palliative care needs. yet, their capacity to support the preparedness and response to an outbreak has some limitations. our study reveals high level of staff anxiety, and a lack of training, material and facilities to handle highly-infectious diseases, especially in the community. the findings demonstrate that the context surrounding the provision of palliative care, such as concerns over security and the lack of running water and soap in the facility and community, may limit the safe implementation of policies and epidemic control measures. these limitations represent barriers to further supporting the national responses to covid- and other outbreaks. the serious concerns we identified over access to water, sanitation, and hygiene, concurs with existing evidence. the findings highlight the importance of palliative care services beyond hands-on care, which should be integrated to strengthen the wider health system response. the common use of outcome measures among african palliative care services to improve patient care may be used to enable health care professionals across the health system to assess and monitor patient and family symptoms and concerns. while palliative care services have expertise and protocols to build capacity among colleagues across the health system, they lack the resources to deliver this crucial contribution of palliative care during public health emergencies. to the best of our knowledge, this study is the first to provide a comprehensive assessment of the preparedness and capacity of palliative care services to respond to a pandemic in palliative care ( ) the use of the smartsurvey platform has enabled a fast and user-friendly data collection while preventing multiple completion from a single computer. although we piloted the survey, the choice of coding generated missing data, and it took longer to complete than estimated (median minutes in practice rather than minutes estimated). . the length of the questionnaire may also explain why respondents only completed the survey partially. we excluded these records because they completed a maximum of two questions after describing their covid- situation (section of the questionnaire out of ). we felt that including these records would carry a high number of unnecessary missing data in the sections that actually described their preparedness and capacity to respond. participation relied almost solely on internet completion, even if alternative means were provided. this study provides much-needed evidence on the preparedness and capacity of african palliative care services to respond to covid- staff anxious about the need to care for their children who may not be at school ( - ) staff anxious about the need to care for their own relatives ( - ) staff anxious about getting infected themselves ( - ) worried regarding potential issues for your interaction with the community if your service is known to manage a potential covid- case ( - ) staff are at risk of being infected by covid- ( - ) service is at risk of closing because of an infection in the service ( - ) staff doing screening or exchanges on social media between staff community and volunteers in the community national centre for diseases control / national hygiene institute local authority or committee none reported other person who would be informed in the service : head of nursing or palliative care, person in charge or project manager hospital or facility management or health services coordinator all staff / team none reported in the facility or hospital covid- response team in the hospital or facility other missing j o u r n a l p r e -p r o o f no conflict of interest to disclose. ethical approval was received from the hospice africa uganda research and ethics committee (haurec - ). note: * means compulsory reply • if no, you cannot take part in the survey. <send to thank you page with resources > aim of the survey: to rapidly assess the preparedness and capacity to face the covid- pandemic of hospices and palliative care services in africa. hospices and palliative care services provide complex care to a population considered at high-risk to develop severe to critical forms of covid- . we aim to assess the level of preparedness of hospice and palliative care services in africa in order to identify the resources and support that are needed. the findings will inform recommendations to strengthen preparedness and potential response to the current covid- and the potential re-occurence. we hope to use the data to urgently lobby for the appropriate resources within country and from external donors. the african palliaative care association (apca) and the cicely saunders institute for palliative care and rehabilitation (csi) at king's college london. the african palliative care association (apca) is a pan-african non-profit organisation mandated with promoting and supporting culturally appropriate palliative care across africa, through education and training, advocacy, and development of standards of care. it works collaboratively with existing and potential providers of palliative care services to help expand service provision; and work with governments and policymakers to ensure the optimum policy and regulatory framework exists for the development of palliative care across africa (www.africanpalliativecare.org). the centre for global health palliative care at the csi focuses on research and education with partners around the word to ensure that high quality appropriate palliative care can be delivered to those who need it (www.kcl.ac.uk/cicelysaunders/global-health/about-us) data collected and confidentiality: data are collected and stored following the uk general data protection regulation. the data collected are anonymous. only aggregated data that would not enable the identification of individuals will be shared in publications. data collected on this platform are collected and stored in the united kingdom using encryption. once the online survey will be closed, the data on this platform will be transferred to a secured encrypted server at king's college london and deleted from this platform. if you chose to complete the survey using word or during a phone call, the information you give will be stored at the african palliative care association offices. an electronic version of the anonymised data will be shared with the team based at king's college london, where the data will be stored on a secured encrypted server. • yes, please specify ..... no don't know if you answered yes to any of the above: did you put the measure in place following the instructions from health management or regional authorities, or did your hospice take them spontaneously? following the instructions spontaneously both please share if you have additional comment: .. ................................................................................................ .......................................................................................................................... predictors of mortality for patients with covid- pneumonia caused by sars-cov- : a prospective cohort study clinical features of patients infected with novel coronavirus in wuhan, china. the lancet clinical characteristics of coronavirus disease in china covid- and african americans is ethnicity linked to incidence or outcomes of covid- ? intensive care unit capacity in low-income countries: a systematic review clinical features of patients infected with novel coronavirus in wuhan is palliative care costeffective in low-income and middle-income countries? a mixed-methods systematic review a systematic review of palliative care intervention outcomes and outcome measures in low-resource countries characteristics, symptom management and outcomes of patients with covid- referred for hospital palliative care pandemic palliative care: beyond ventilators and saving lives alleviating the access abyss in palliative care and pain relief-an imperative of universal health coverage: the lancet commission report the african palliative care association (apca) atlas of palliative care development in africa: a comparative analysis the escalating global burden of serious health-related suffering: projections to by world regions, age groups, and health conditions. the lancet global health palliative care in humanitarian crises: a review of the literature the role and response of palliative care and hospice services in epidemics and pandemics: a rapid review to inform practice during the covid- pandemic. j pain symptom manage. . . world health organisation. who african region covid- readiness status v bull world health organ. . . eysenbach g. improving the quality of web surveys: the checklist for reporting results of internet e-surveys (cherries) guide to the design and application of online questionnaire surveys response and role of palliative care during the covid- pandemic: a national telephone survey of hospices in italy clinical management of patients with viral haemorrhagic fever: a pocket guide for front-line health workers. interim emergency guidance for country adaption: world health organization health system preparedness for emerging infectious diseases: a synthesis of the literature lessons from the ebola outbreak: action items for emerging infectious disease preparedness and response pandemic influenza preparedness (pip) framework: progress challenges in improving influenza preparedness response capacities in the eastern mediterranean region pandemic influenza preparedness in africa is a profound challenge for an already distressed region: analysis of national preparedness plans. health policy and planning pandemic influenza preparedness in the who african region: are we ready yet? strategy and technology to prevent hospitalacquired infections: lessons from sars, ebola, and mers in asia and west africa open questions on questionnaires -a bane or a bonus to research wash in health care facilities: global baseline report . geneva: world health organization and the united nations children's fund covid- pandemic in west africa palliative and end-of-life care in the global response to multidrug-resistant tuberculosis community health workers during the ebola outbreak in guinea, liberia, and sierra leone ebola outbreak ending as congolese face new 'triple threat' of covid- , poverty and violence reliefweb understanding data and information needs for palliative cancer care to inform digital health intervention development in nigeria, uganda and zimbabwe: protocol for a multicountry qualitative study lessons learnt from implementation of the international health regulations: a systematic review integrating palliative care and symptom relief into responses to humanitarian emergencies and crises: a who guide. world health organization we would like to thank joan lysias and delphine rahib for early comments on the survey questionnaire. yes no -comment: ................................................................................................ key: cord- -abvtl ov authors: imtiyaz, bushra s; garratt, elisabeth a; cox, joanna h; keynejad, roxanne c title: telemedical education during national emergencies: learning from kashmir date: - - journal: clin teach doi: . /tct. sha: doc_id: cord_uid: abvtl ov nan t he coronavirus pandemic of has highlighted both similarities and vast inequalities between nations. periods of preparation, lockdown and recovery from covid- , staggered across regions, have refocused national priorities on strengthening health system capacity, scaling up acute care, future-proofing economies and adapting education for remote delivery. disruption to formal education is not unusual in countries experiencing multiple continuing crises. regions affected by both geoclimatic vulnerability and chronic political unrest regularly experience interruptions to health care and education provision. between and , the schools and colleges of kashmir, northern india, were closed for % of all working days. the region is currently nearing a full year under lockdown. high-quality medical education remains essential to health care delivery, especially during high-quality medical education remains essential to health care delivery, especially during pandemics and periods of geopolitical and sociopolitical unrest pandemics and periods of geopolitical and sociopolitical unrest. covid- has increased the global recognition of health care workers, highlighting the need for uninterrupted clinical education. with nations forced to recruit medical and nursing students to deliver frontline care, rapidly expand bed capacity and share ventilators, the coronavirus pandemic has exposed the scarcity of health care resources globally. low-and middle-income countries (lmics) are especially vulnerable and most in need of continued remote education and training. in the long term, frequent disruption to health care education can impact clinical standards and encourage a 'brain drain' of skilled professionals to highincome regions. innovative pedagogical approaches are required to fill gaps in medical education, especially during global health emergencies such as covid- . e-learning has been recognised by the world health organization (who) as an important means of addressing health workers' educational needs, especially in lmics. remotely delivered psychiatry education is particularly necessary for the many regions where the provision of mental health care is sparse. a recent lancet commission emphasised the benefits to global mental health of digital technologies, for the training and supervision of health workers, as well as for the provision of care in the most remote and underserved regions. online methods pose as many challenges as solutions, however. massive open online courses (moocs) have particularly low completion rates, attributed to the lack of personal contact, limited feedback or monitoring that learners receive. if the future of medical education must be at least partly online, how can e-learning initiatives maximise their appeal to learners and ensure continued engagement? peer learning can enhance medical education when senior faculty members must prioritise clinical care. a peer-to-peer e-learning partnership ('aqoon') between medical students from somaliland and the uk demonstrated reciprocal knowledge and cross-cultural benefits. the model, employing the lowbandwidth medicineafrica website, has been iteratively refined for the post-conflict somaliland context since , and continues to evolve. could aqoon be applicable to learners in a dramatically different setting, facing unique barriers to continued education (boxes and )? frequent internet and communication blackouts in conflict regions may be the biggest impediment to their feasibility. internet access in kashmir remains restricted to low-speed g services, impacting the general population and health care professionals' ability to keep up to date with clinical guidelines and research developments. where connectivity, electricity and the availability of computers and smartphones are limited, more conventional alternatives may be required. radio and television broadcasts lack the real-time interaction, bi-directional communication and instant feedback of a simulated classroom environment, however. user-friendly interfaces, versatility and familiarity to learners make online approaches preferable in settings where the internet is reliable. political commitment to ensure fast and continuous internet connectivity, at least for professionals working in essential services and delivering clinical education, is increasingly important. digital literacy and the availability of affordable technologies impact the accessibility of online education. three years after the flagship 'digital india' launch, india was one of the world's most rapidly digitising nations. in china, the ministry of education has directed major telecommunication service providers to boost internet connectivity and upgrade the bandwidth of online education service platforms in the wake of covid- . similarly, telecommunication companies in croatia are providing free internet access to innovative pedagogical approaches are required to fill gaps in medical education, especially during global health emergencies such as covid- • we piloted a global mental health e-learning partnership between volunteer medical students in kashmir and the uk in . kashmir was gradually rebuilding after severe flooding in and a major earthquake in . we guided five pairs of student volunteers to meet online for fortnightly, hour-long, peer-led tutorials covering topics from the who mental health gap action programme (mhgap) intervention guide. we used fortnightly e-mails to remind partners to read specified mhgap chapters covering core psychiatric presentations before discussing their understanding and clinical experience online, in pairs. • we used pre-and post-course questionnaires to evaluate the programme and elicit student reflections (box ). kashmir students gained confidence and knowledge about clinical presentations, diagnosis and treatment options. one said that they 'now better appreciate the role the society can play with regards to management and rehabilitation' . uk learners gained opportunities for examination revision and understanding of cross-cultural differences in clinical presentations, help-seeking, management, education and health systems. ninety percent of students would recommend the programme to a friend and one kashmiri participant went on to pursue specialty psychiatry training. the model benefitted from the medicineafrica platform's design for low bandwidths; however, the requirement for reliable internet was a key limitation. students of low socio-economic status. teaching methods must be flexible if they are to ensure the continuity of medical education during turbulent times. elearning models represent low-cost innovations that can be customised to the clinical and pragmatic context. peer learning has the potential to benefit learners in more-and lessresourced settings alike, whilst the resurgence in volunteerism provoked by covid- could see skilled, knowledgeable professionals who are unable to deliver front-line care instead giving their time and expertise for remote education. such initiatives require the same rigor and quality standards as any face-toface teaching. the coronavirus pandemic presents challenges and opportunities. one is to develop the evidence base for e-learning models using randomised methods in larger samples, to determine their scalability and suitability to current needs. lessons learned in the aftermath of emergencies can benefit long-term practice and preparedness to respond to future upheaval. although the first priority of covid- must be clinical care, the need to strengthen health systems, health professionals and clinical education must not be neglected. world health organization. elearning for undergraduate health professional education -a systematic review informing a radical transformation of health workforce development the lancet commission on global mental health and sustainable development the moocs: origin, characterization, principal problems and challenges in higher education global health partnership for student peer-to-peer psychiatry e-learning: lessons learned building back better: sustainable mental health care after emergencies the views expressed in this publication are those of the authors and not necessarily those of the nihr or the department of health and social care. funders played no role in the study design, data collection, data analysis, data interpretation, or report writing. all authors declare that they have no competing interests. ethical approval: the aqoon-kashmir course mentioned in this insight article was an education initiative and the feedback that learners provided was confirmed to constitute service evaluation and not research. learners provided this feedback voluntarily, giving informed consent through online evaluation surveys for their data to be submitted for publication. discussing different [who mental health gap action programme] mhgap topics with my partner in kashmir helped to consolidate my knowledge of symptoms, diagnosis and management strategies for common psychiatric conditions. perhaps more importantly, we discussed the position of mental health within our respective health care systems. i found this aspect of the partnership particularly instructive. the experience has helped me to appreciate our mental health service infrastructure, despite its limitations. key: cord- -ria v p authors: mcdarby, geraldine; reynolds, lindy; zibwowa, zandile; syed, shams; kelley, ed; saikat, sohel title: the global pool of simulation exercise materials in health emergency preparedness and response: a scoping review with a health system perspective date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: ria v p simulation exercises (simex) are an established tool in defence and allied security sectors, applied extensively in health security initiatives under national or international legislative requirements, particularly the international health regulations ( ). there is, however, a paucity of information on simex application to test the functionality of health systems alongside emergency preparedness, response and recovery. given the important implications health services resilience has for the protection and improvement of human life, this scoping review was undertaken to determine how the publicly available body of existing global simex materials considers health systems, together with health security functions in the event of disruptive emergencies. the global review identified articles from literature and products from institutional sources. relevant screening identified materials suitable to examine from a health system lens using the six health system building blocks as per the who health system framework. eight materials were identified for further examination of their ability to test health system functionality from a resilience perspective. simex are an effective approach used extensively within health security and emergency response sectors but is not yet adequately used to test health system resilience. currently available simex materials lack an integrated health system perspective and have a limited focus on the quality of services delivered within the context of response to a public health emergency. the materials do not focus on the ability of systems to effectively maintain core services during response. without adjustment of the scope and focus, currently available simex materials do not have the capacity to test health systems to support the development of resilient health systems. dedicated simex materials are urgently needed to fill this gap and harness their potential as an operational tool to contribute to improvements in health systems. they can act as effective global goods to allow testing of different functional aspects of health systems and service delivery alongside emergency preparedness and response. the work was conducted within the scope of the tackling deadly diseases in africa programme, funded by the uk department for international development, which seeks to strengthen collaboration between the health system and health security clusters to promote health security and build resilient health systems. ► simulation exercises (simex) are established, practised in defence and security sectors which are later recognised in national and international regulations (e.g international health regulations, ). ► the importance of simex as an improvement tool has yet to be identified to test capacities for health system resilience alongside emergency preparedness. what are the new findings? ► currently available global pool of simex materials lack an integrated health system perspective with a limited focus on the maintenance of routine quality health services delivered during response to a public health emergency. ► without adjustment of the scope and focus, currently available global pool of publicly available simex materials do not have the capacity to test health system resilience. what do the new findings imply? ► participation of health system authorities or stakeholders in the development, conduct of simex and accountability of findings for improvement in health system strengthening is needed. ► dedicated simex materials are urgently needed to fill gaps identified in global resources to harness the potential of simex as an operational tool to contribute to improvements in health system strengthening. simulation exercises (simex) are an established tool in defence and allied security sectors, applied extensively in health security initiatives under national or international legislative requirements, particularly the international health regulations ( ) . there is, however, a paucity of information on simex application to test the functionality of health systems alongside emergency preparedness, response and recovery. given the important implications health services resilience has for the protection and improvement of human life, this scoping review was undertaken to determine how the publicly available body of existing global simex materials considers health systems, together with health security functions in the event of disruptive emergencies. the global review identified articles from literature and products from institutional sources. relevant screening identified materials suitable to examine from a health system lens using the six health system building blocks as per the who health system framework. eight materials were identified for further examination of their ability to test health system functionality from a resilience perspective. simex are an effective approach used extensively within health security and emergency response sectors but is not yet adequately used to test health system resilience. currently available simex materials lack an integrated health system perspective and have a limited focus on the quality of services delivered within the context of response to a public health emergency. to disease outbreaks. health workers were significantly more likely to be infected than the general population, with this increased risk largely attributable to the poor quality of infection prevention and control (ipc) practices and emergency preparedness. [ ] [ ] [ ] guinea, liberia and sierra leone lost between . % and . % of their country's doctors, nurses and midwives to evd, translating into significant reductions in the healthcare provision. ineffective surveillance systems enabled evd to spread locally as well as across borders. during an outbreak, as with any public health emergency (phe), the resilience of a country's health system is tested in real time. the capacity to respond to an outbreak and maintain essential services creates a surge in demand for critical resources. health system resilience has been defined as 'the capacity of health actors, institutions, and populations to prepare for and effectively respond to crises; maintain core functions when a crisis hits; and, informed by lessons learned during the crisis, reorganize if conditions require it.' resilient health systems protect human life and are linked with positive health outcomes during a phe as well as in its aftermath. a lack of health system resilience is associated with excess morbidity and mortality due to the phe as well as from other causes, which can be at least partially attributed to a reduction in access to quality health services. [ ] [ ] [ ] it has been estimated that a % reduction in access to healthcare services during the west african evd resulted in increased child and maternal mortality as well as increased mortality from other infectious diseases. these indirect deaths- -were not insignificant. thus, it is critical that a mechanism exists to test and build resilient health systems in order to reduce excess morbidity and mortality from future phes. national and international preparedness for phes has long been discussed on a global scale, especially in health security forums that seek to address challenges and gaps in meeting core international health regulations (ihr) ( ) capacities. one component of the revised ihr ( ) monitoring and evaluation framework includes simulation exercises (simex), which are defined by the who as 'forms of practice, training, monitoring or evaluation of capabilities involving the description or simulation of an emergency, to which a described or simulated response is made.' simex have historically been an established tool in defence and allied security sectors, with recent adaptation to health security efforts in the context of disruptive emergencies, natural and man-made. they are now being used as a tool to assess compliance with national-for example, the uk civil contingencies act -and international legislative requirements, notably ihr . there is, however, a paucity of information on the application of these exercises to test the functionality of health systems alongside emergency preparedness, response and recovery. simex are also an ideal opportunity to test preparedness of the various functions of the health system, particularly health service delivery, in response to phes. this would contribute to the development of strong linkages between health systems and health security sectors supporting an integrated approach towards building resilient health systems. given the important implications health services resilience has for the protection and improvement of human life, this scoping review was undertaken to determine how the body of existing global simex materials considers the testing of health system resilience, together with health security preparedness, and response functions in the event of acute and/or protracted phes. recognising the dispersion of simex materials, a scoping review of academic literature as well as an institutional search was undertaken. a wide search strategy was employed to identify all relevant materials. searches of different hazard types, exercise types and subject areas were combined (online supplementary appendix ). the initial search returned articles for screening with an additional identified through bibliography review. titles and abstracts were reviewed against inclusion and exclusion criteria (table ) , reducing the number for fulltext review to . for the institutional search, institutions involved in the development, implementation or evaluation of simex were identified by experts in the field, as well as through relevant articles. their websites were searched for applicable materials. ultimately, institutions, ranging from academic to national response agencies, were reviewed (online supplementary appendix ), identifying materials which were reduced to following the screening of aims and objectives (figure ). the final materials identified (n= ; online supplementary appendix ) ( emerging from the literature and emerging from institutional review) were analysed by two independent reviewers for their scope to test aspects of health systems using the who health system framework, consisting of six independent but inter-related building blocks (table ) . resilience was considered to be addressed if materials demonstrated evidence of an integrated emergency response, maintenance of essential functions or reorganisation of services within the context of a phe. a smaller number of materials (n= ) were bmj global health ► does the material look at aspects of health service delivery in the event of a simulated event? ► does the material test a function of specific building blocks of a health system in consideration of other related building blocks? ► does the material test preparedness and response of healthcare facilities alongside national incident management system? ► does the material look at impact of emergencies on provision of routine essential health services? ► does the material look at how phes impact health service delivery at subnational and district-level facilities? ► does the material examine the standard of care during phe? identified for examination of their scope to test resilience from a functional perspective (figure and box ). materials were excluded from this portion of the analysis if they did not report either an exercise or objectives in sufficient detail to support this analysis. this portion of the analysis (n= ) involved five journal articles and three guidance materials (online supplementary appendix ). a library of publicly available materials to support the development of simex was compiled in parallel to the review process. there was no involvement of patients or the public in this study, in either the design of the methods or in the conduct of the study. results simex consideration of health system building blocks the majority ( %) of the materials (n= ) identified exclusively tested preparedness and response to a phe, without considering them as typical functions of a resilient health system (figure ). a limited number were identified that tested aspects of health system resilience or recovery (figure ). the categorisation of the scope of material was based on the research bmj global health team's interpretation, that is, if the exercises dealt with preparing and responding to a phe or if they dealt with aspects of recovery or response. a few materials self-identified as testing health security or testing for contingency, and so warranted extra categories. the materials identified looked at aspects of health security across different geographical levels (international, national, regional and facility); they more frequently examined the regional/ district ( %) and facility levels ( . %) ( figure ) . the most frequent hazard type ( %) simulated was biological which included pandemic influenza and other emerging infections ( figure ) . though often not the explicit focus, all reviewed materials (n= ) tested at least one building block or an aspect of a health system building block (figure ). a functional approach was apparent, though functions were generally tested in a narrow way both within and across relevant building blocks, rather than integrated across all relevant health system building blocks. ipc was the most commonly tested service delivery function with adherence to case management guidelines and standard operating procedures (sop) being a frequent focus of testing. the quality of health services provided in the context of the response or measures of the maintenance of essential health services were lacking. surge capacity was the most frequently tested function of health workforce, though a narrow approach was often apparent. exercises tested aspects of surge capacity such as staffing, however, this was not addressed within other building blocks in relation to the invariable increased demands on services and supplies. a narrow approach to health information systems was also apparent, with three materials (out of ) focusing on surveillance systems and only limited aspects of risk communication tested. only one identified material tested the triggering of a response plan using a surveillance system. leadership and governance (from a security perspective) was the most frequently addressed building block, with many materials testing aspects of this building block such as response plans and roles and responsibilities of responders. however, alignment with national structures and guidelines was not apparent, nor was consideration given to decision in risk identification. while access to medicines and supplies was frequently alluded to, testing of access to mechanisms or supply chain resilience was infrequent. financing was alluded to in only % of materials (n= ), but testing of mechanisms to access funding in the event of phes was not identified. tabletop exercise/discussion was the most frequent approach identified (figure ). they are less expensive and faster to execute, particularly when considering large groups of stakeholders. the limitation with this approach bmj global health is limitation in scope to adequately simulate phes and test the individual and integrative aspects of health systems. simex consideration of health system functionality and system underpinning eight materials were identified for further analyses on the functionality/system aspect of the six building blocks, using a set of questions (box ). most materials tested activation of appropriate emergency response mechanisms and structures within the respective administrative levels tested, for example, a facility-level exercise testing activation of all appropriate response mechanisms within the health facility. some materials tested activation across different levels within the system, for example, a health facility responding to an outbreak activating regional or national response systems. emergency response systems were generally assumed to have been activated, without testing system triggering. as was apparent with the building block analysis, healthcare functions were generally not tested in an integrated way. for example, a mass dispensing drill had no regard for the parallel response structures with which they would have to integrate during a response. similarly, a facility response to a sarin attack failed to integrate with national response agencies. reporting of alignment with national command and control structures or response plans was limited as was evidence of consideration of the impact of the phe on other health system-level facilities or management structures. materials to test the impact of emergencies on primary healthcare (phc) or its response were extremely limited and community resilience materials, where identified, failed to link with health systems. [ ] [ ] [ ] the materials were limited in their focus on testing the quality of services delivered in the context of response to a phe. where present, measures tended to focus on clinical aspects of care rather than system and process measures. measures to test the maintenance of essential services from a quality perspective were not identified in any of the eight selected materials. limitations of the review the application of the health system framework to review simex materials introduced a degree of subjectivity. in reality, it is the same health system that provides routine healthcare, emergency-specific healthcare and response to a shock impacting public health. this was addressed through discussion as well as with input from health system and security experts in who. similarly, the approach to the analyses conducted required sufficient detail in the identified materials in relation to exercises or objectives, which led to the exclusion of a number of relevant materials as they were not present either with sufficient details or as a package (written narrative, scenario, injects and postexercise report). both the academic literature and institutional materials were analysed using the same approach. this likely led to an underestimation of effect in relation to academic literature as not all that was tested may have been reported, and an overestimation in relation to institutional materials as objectives may not have been applied effectively within exercises. a publication bias also likely exists in relation to health security exercise reports and materials given the sensitive nature of findings as well as in relation to materials developed and delivered by private companies. while multiple institutions and organisations (n= ) known to be involved in simex were contacted to identify unpublished materials, it is likely that there remains a pool of materials not made available as they were considered proprietary and/or sensitive. however, the objectives of the exercise are based on publicly available materials that are accessible and can be used as global resources, as such access-restricted materials fall beyond the scope of this review. in general, materials identified were from countries with developed capacities for emergency preparedness and response-materials from other settings may not have percolated the literature and may not have an institutional home where materials are placed. however, the inclusion of institutions known to support simex within low income settings is likely to reduce the impact of the bias towards high-income countries within the findings of the work. the exclusion of non-english materials has the potential to introduce a cultural bias, although materials in the review included materials from most continents (north america, europe, africa, asia and australia). the extent of any cultural bias is therefore limited, and unlikely to affect the findings of the work. despite these limitations, there is no reason to suspect that materials not included in this review differ systematically from those included in such a way as to negate the findings. discussion while all materials identified tested aspects of health systems, there was limited evidence of an integrated health system approach. health system building blocks were touched on from a preparedness perspective, and often tested in a fragmented and isolated way without addressing interlinkages. ipc was frequently tested in the context of response to a pandemic or other emerging infection, with a focus on governance structures and adherence to case management and sops. ipc is central to the response to any emerging infection as was highlighted within the evd outbreak in west africa where poor ipc practices contributed to significant health worker transmission, leading to reductions in response as well as essential healthcare delivery. in a similar instance, a lack of strict adherence to ipc guidelines was associated with ongoing healthcare facility transmission during the severe acute respiratory syndrome outbreak in both toronto and taiwan in . an integrated approach to ipc as a critical function of quality health service delivery in these simex materials is thus required. the availability and timeliness of emergency financing is critical in determining the timeliness and effectiveness of coordinated efforts in any emergency response. despite this, limited consideration was given to the supply of resources required to meet the surge in demand, including staff, diagnostics, medicines or personal protective equipment, and to accessing the financing necessary to meet these demands. it is therefore of utmost importance that the rapid mobilisation of financing should be regularly tested in simex, taking into account the response required as well as consideration of maintaining quality essential health services. health information systems, though often alluded to, were rarely tested in a robust and integrated way, with a lack of focus on surveillance systems in particular. the only material identified that tested activation of an emergency plan using syndromic surveillance failed to trigger activation of the response plan. the pivotal role played by data and information systems in routine healthcare delivery is even greater in the context of emergencies. a strong and reliable health information system ensures understanding of the epidemiology of disease, and is critical in coordination, communication and management of response efforts. testing this functionality should be an integral part of simex conducted at any level. consideration of the integration of preparedness and response across health system levels was lacking, with services and facilities tending to test their own response capabilities in isolation. phc, despite being the likely first point of care in many phes, was rarely considered in the simex materials reviewed either in terms of supporting preparedness capacity or in terms of the effect of the phe on phc. phc plays a central role in surveillance which was highlighted within the evd outbreak in west africa, where failure to identify evd when it first presented within the community in guinea led to a significant delay in response with a concomitant lack of containment. despite evidence from evd west africa that community linkages can support health system response in the face of phes, the current global pool of simex materials were unlikely to link with community aspects and where community preparedness materials existed they rarely linked with health systems. the importance of integrating private healthcare facilities into emergency preparedness and response capabilities was highlighted by the recent dengue outbreak in khyber pakhtunkhwa in . a private health facility, unfamiliar with emergency response protocols, failed to activate emergency response mechanisms in a timely manner. this, alongside a lack of case management guidelines, contributed to prolonged community transmission. no evidence of integration of private healthcare facilities into health system preparedness and response was identified within the current pool of global simex materials. while there is international consensus of the need to focus on quality in healthcare, the focus on the quality of services delivered in the context of a phe was lacking. where materials did focus on service quality, they tended to focus on clinical aspects of care. system and process measures were only identified in drills that tested mass dispensing capabilities in the context of a pandemic or biological attack. these capabilities represented parallel bmj global health response structures and their linkages with appropriate health system structures were not tested, nor was the communication required to divert individuals from normal health services tested. no materials identified included measures to test the maintenance of or quality of essential health services during the response to a phe. evidence from west africa shows that the indirect mortality and morbidity associated with discontinuity of health services as well as poor quality health services was significant across the three countries, with the biggest impact on maternal and child health. the current global pool of simex materials are limited in its ability to test health service resilience alongside preparedness and response. this in turn limits the opportunity to practically bridge health security and health systems at different administrative levels. special attention is required in using simex approaches to drive sustainability of investment in health security preparedness or disease-specific programmes to proactively position available scarce resources into sector-wide development of health systems for all public health hazards per ihr ( ). simexercises are a well-practised method of testing and promoting emergency preparedness and response for local, national and global health threats. while much experience exists globally in this area, the proprietary nature of some of the materials creates a missed opportunity for the sharing of knowledge across global health security and preparedness communities. it would be in the interest of the global community to develop a mechanism to support sharing of lessons learnt that respects the integrity of private organisations involved in simex development and delivery. the effectiveness of simex has been demonstrated in identifying gaps in emergency response plans, skills and associated resources. the lack of an integrated health system perspective in the current global pool of simex materials limits their ability to support health system functionality and strengthening in the context of phes. this, along with their lack of focus on the quality of response and the maintenance of quality essential health service functions, means that they do not have the capacity to support health system resilience. the incorporation of a health system perspective into simex materials has the potential to enhance health system strengthening and the development of resilience alongside emergency response and health security capabilities. an integrated approach to simex including health security, emergency preparedness and health systems is required to address the gap identified by this review. as a result of these findings, an off-the-shelf simex package that addresses health system aspects within the context of response to a phe is being developed, which will be freely available for all countries, particularly low-income countries. this could be further supported through the cross involvement in ongoing exercises and after-action reviews to enhance connectivity and support the development of shared ownership of improvement recommendations. these new-generation simex materials could be collated in a global repository that could be accessed by national authorities. such a collaborative approach would allow the leveraging of the considerable expertise in simex present within health security and emergency preparedness sectors. lessons learnt from this integrated approach will allow health systems to be built better, function better, which will ultimately lead to the protection and improvement of human life. world health organisation. health worker ebola infections in guinea, liberia and sierra leone: a preliminary report health-care worker mortality and the legacy of the ebola epidemic ebola virus disease in health care workers--sierra leone what is a resilient health system? lessons from ebola building resilient health systems: a proposal for a resilience index effects of response to - ebola outbreak on deaths from malaria, hiv/aids, and tuberculosis, west africa the ebola outbreak and staffing in public health facilities in rural sierra leone: who is left to do the job? counting indirect crisis-related deaths in the context of a low-resilience health system: the case of maternal and neonatal health during the ebola epidemic in sierra leone world health organisation. development, monitoring and evaluation of functional core capacity for implementing the international health regulations ( ): concept note world health organisation. after action reviews and simulation exercises: under the international health regulations monitoring & evaluation framework (ihr mef) what is the value of health emergency preparedness exercises? a scoping review study a test of syndromic surveillance using a severe acute respiratory syndrome model the planning, execution, and evaluation of a mass prophylaxis full-scale exercise in cook county sarin exposure: a simulation case scenario emergency preparedness toolkit for primary care providers academic-community partnership to develop a novel disaster training tool for school nurses: emergency triage drill kit whole community: planning for the unthinkable tabletop exercise sars in healthcare facilities the financial logistics of disaster: the case of hurricane katrina who paints grim picture of anti-dengue preparedness. reliefweb high-quality health systems in the sustainable development goals era: time for a revolution delivering quality health services: a global imperative for universal health coverage ready or not: analysis of a no-notice mass vaccination field response in philadelphia hospital emergency preparedness: push-pod operation and pharmacists as immunizers a scoping review of evaluation methods for health emergency preparedness exercises contributors ssa conceptualised the study. ssa, gm and zz designed the methods. gm, lr and ssa conducted the literature search. gm and lr collected the data. gm, lr and zz developed the figures. gm, lr, ssa, zz, ek and ssy all contributed to data analysis, data interpretation, manuscript writing and reviewing.funding this study was funded by world health organization.competing interests none declared. provenance and peer review not commissioned; externally peer reviewed. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. key: cord- - cragfka authors: bhutta, zulfiqar a.; yount, kathryn m.; bassat, quique; arikainen, artur a. title: revisiting child and adolescent health in the context of the sustainable development goals date: - - journal: plos med doi: . /journal.pmed. sha: doc_id: cord_uid: cragfka nan . effort is limited to bring mental-health programming to women and children, especially in conflict settings or emergencies such as the covid- pandemic. these silos in research, planning and policy, and service delivery apply equally to other sectors, and to multisectoral planning and implementation at country level. to address the sdgs, we must consider life in the st century-including the disruptions of technological change, economic shocks, climate change, and conflict and security. thus, as we seek to reposition child health in the context of the sdgs and to eliminate preventable child deaths, we need a life-course perspective that is situated in a broader social and structural context. this framework recognizes the multilevel social contexts into which children are born and the long-term health impacts of early exposure to deprivation, inequality, and unsustainable growth. we recognize that healthy trajectories from birth to adolescence and beyond depend on the extent to which key stakeholders-governments, businesses, and civil societies-prioritize investments in human capabilities, reductions in inequality, and inclusive, sustainable economies [ ] . in conceptualizing the life course from birth to adulthood in terms of trajectories of healthy growth, learning, and development, there are predictable touch points where investments can be made and progress monitored-growth before age years, readiness for school, developmental and academic milestones in school, and social milestones with respect to family, peer, and dating relationships. a contextually situated lifecourse perspective for human development across childhood, as opposed to early childhood alone, conceptualizes exposures and opportunities from conception to adulthood, with each life stage building on the previous stages in social context. this 'contextual' and 'cumulative' perspective is important for understanding trajectories of survival, health and development throughout childhood and adolescence and the 'reciprocal' social and economic contributions that healthy, fulfilled adults can make to inclusive, sustainable societies. recognizing the interconnectedness of capabilities also allows investments in one domain to attenuate vulnerabilities in another (e.g., ensuring that all children receive a high-quality education may attenuate vulnerabilities associated with stunting among the marginalized). given the strong predictions of cumulative disadvantage for long-term health, disrupting these trajectories requires collaboration among key stakeholders. some decades after the world embarked on the mdgs, we need to focus on reaching the unreached through cross-sectoral delivery platforms and strategies that prioritize the most excluded and vulnerable [ ] . still, high-quality programs within the health system remain important, and require redesign to meet the needs of children and adolescents. achieving this high quality will require inclusion of trained providers, competent delivery systems, and an emphasis on dignity and trust in provider-client relationships, especially with the most excluded. today, the quality of services for sick children is substandard, with only % of recommended integrated management of childhood illness (imci) clinical interventions delivered in a visit. system-wide deficits include minimal service offerings for adolescents, or even children beyond the age of years, and misplaced services, with many births occurring in facilities that cannot care for the very sick newborn. the path forward for improvement is to focus on structural solutions that place the child and family at the center of the health system's mission, address social inclusion of marginalised groups, and help develop high-quality health systems for improving child health [ ] . health can be an entry point, yet collaboration across stakeholders and sectors, such as education, social media, and social protection, are critical to reduce disparities and foster capabilities for health and well-being. the sdgs have a broader agenda, translated into "survive-thrive-transform" in the global strategy for women's, children's and adolescents' health - , with major targets and indicators in the health sector and beyond. we remain concerned that the gains in early child health painstakingly achieved in the mdg period are at risk of slowing down and losing priority. the global challenges of improving survival and health from birth through adolescence remain, and the world needs to redouble its efforts to do better, rather than declare victory prematurely and move on. in a forthcoming plos medicine special issue [ ] , we are inviting impactful research in this important area on strategies to monitor and combat child mortality globally from birth through adolescence, school-age health and welfare, marginalised populations, and the environmental impacts on children's health. we hope that this special issue will help to redirect attention to child and adolescent health in years to come. early estimates of the indirect effects of the covid- pandemic on maternal and child mortality in low-income and middleincome countries: a modelling study what is the global strategy? in: who. world health organization nurturing care for early childhood development: linking survive and thrive to transform health and human potential framework and strategy for integrated monitoring and evaluation of child health programmes for responsive programming, accountability, and impact adolescence and social determinants of health: family and community, in adolescent health and wellbeing development and validation of the sexual and reproductive empowerment scale for adolescents and young adults. j adolesc health off publ soc adolesc med sexual and reproductive health outcomes of violence against women and girls in lower-income countries: a review of reviews progress in adolescent health and wellbeing: tracking headline indicators for countries and territories charting a pathway to multisectoral investments in adolescent health in low-and middle-income countries high-quality health systems in the sustainable development goals era: time for a revolution special issue: global child health: from birth to adolescence and beyond key: cord- - ra uda authors: snowden, frank m. title: emerging and reemerging diseases: a historical perspective date: - - journal: immunol rev doi: . /j. - x. . .x sha: doc_id: cord_uid: ra uda summary: between mid‐century and , there was a consensus that the battle against infectious diseases had been won, and the surgeon general announced that it was time to close the book. experience with human immunodeficiency virus/acquired immunodeficiency syndrome, the return of cholera to the americas in , the plague outbreak in india in , and the emergence of ebola in zaire in created awareness of a new vulnerability to epidemics due to population growth, unplanned urbanization, antimicrobial resistance, poverty, societal change, and rapid mass movement of people. the increasing virulence of dengue fever with dengue hemorrhagic fever and dengue shock syndrome disproved the theory of the evolution toward commensalism, and the discovery of the microbial origins of peptic ulcer demonstrated the reach of infectious diseases. the institute of medicine coined the term ‘emerging and reemerging diseases’ to explain that the world had entered an era in which the vulnerability to epidemics in the united states and globally was greater than ever. the united states and the world health organization took devised rapid response systems to monitor and contain disease outbreaks and to develop new weapons against microbes. these mechanisms were tested by severe acute respiratory syndrome in , and a series of practical and conceptual blind spots in preparedness were revealed. in the long contest between humans and microbes, the years from mid-century until marked a distinctive era. in those euphoric decades, there was a consensus that the decisive battle had been joined and that the moment was at hand to announce the final victory. almost as if introducing the new period, the us secretary of state george marshall declared in that the world now had the means to eradicate infectious diseases from the earth. marshall's view was by no means exceptional. for some, in the early postwar years, the triumphant vision applied primarily to a single disease. the heady goal arose first of all within the field of malariology, where the rockefeller foundation scientists fred soper and paul russell thought that they had discovered in ddt (dichlorodiphenyltrichloroethane) a weapon of such unparalleled power that it would enable the world to eliminate the ancient scourge forever. with premature confidence in , russell published man's mastery of malaria ( ), frank m. snowden in which he envisaged a global spraying campaign that would free mankind from malaria -cheaply, rapidly, and without great difficulty. rallying to russell's optimism, the world health organization (who) adopted a global campaign of malaria eradication with ddt as its weapon of choice. the director of the campaign, emilio pampana, elaborated a one-size-fits-all program of eradication through four textbook steps -'preparation, attack, consolidation, and maintenance' ( ). russell's followers alberto missiroli, the director of the postwar campaign in italy, and george macdonald, the founder of quantitative epidemiology, reasoned that so signal a victory over mosquitoes could be readily expanded to include the elimination of all other vector-borne tropical diseases, ushering in what missiroli called a contagion-free eden, where medicine would make man not only healthy but also happy ( ) ( ) ( ) . if malariologists, who dominated the international public health community, launched the idea of the final conquest of infectious diseases, it rapidly developed into the prevailing orthodoxy. e. harold hinman, chief malariologist to the tennessee valley authority and member of the who expert committee on malaria, extrapolated from the conquest of malaria to the conquest of all contagion in his influential work world eradication of infectious diseases ( ) . aidan cockburn, a distinguished epidemiologist at johns hopkins and advisor to the who, gave expression to this new creed in his revealingly titled work the evolution and eradication of infectious diseases ( ) . as cockburn noted, '''eradication'' of infectious disease as a concept in public health has been advanced only within the past two decades, yet it is replacing ''control'' as an objective' ( ) . although not a single disease had yet been destroyed by his time of writing in , cockburn believed that the objective of eradication was 'entirely practical,' not just for individual illnesses but for the whole category of communicable diseases. indeed, he argued, 'it seems reasonable to anticipate that within some measurable time, such as years, all the major infections will have disappeared' ( ) . by that time, he explained, 'the major infections of today should have disappeared, and only remaining should be their memories in textbooks, and some specimens in museums. . . . with science progressing so rapidly, such an end-point is almost inevitable, the main matter of interest at the moment is how and when the necessary actions should be taken' ( ) . cockburn's timetable of total eradication by was, in fact, too slow for some. just a decade later, in , the australian virologist and nobel laureate frank macfarlane burnet went so far as to proclaim, together with his colleague david white, that 'at least in the affluent west,' the grand objective had already been reached. 'one of the immemorial hazards of human existence has gone,' he reported, because there is a 'virtual absence of serious infectious disease today' ( ) . the who also saw the entire planet as ready to enter the new era by the end of the century. meeting at alma ata in , the world health assembly adopted the goal of 'health for all, ' ( ) . what could possibly have led to such overweening confidence in the power of science, technology, and civilization to vanquish communicable disease? one factor was historical. in the industrialized west, rates of mortality and morbidity from infectious diseases began to plummet in the second half of the th century, in large part as a result of 'social uplift' -dramatic improvements in wages, housing, diet, and education. at the same time, developed nations erected the solid fortifications of sanitation and public health: sewers, drains, sand filtration, and chlorination of water as defenses against cholera and typhoid; sanitary cordons, quarantine, and isolation against bubonic plague; vaccination against smallpox; and the first effective 'magic bullet' -quinine -against malaria. meanwhile, improvements in the handling of food, pasteurization, retort canning, and the sanitation of seafood beds, yielded major advances against bovine tuberculosis (tb), botulism, and a variety of food-borne maladies. already by the early th century, therefore, many of the most feared epidemic diseases of the past were in headlong retreat for reasons that were initially more empirical and spontaneous than the result of the application of science. science, however, soon added new and powerful weapons. the foundational work of louis pasteur and robert koch had established the biomedical model of disease that promoted unprecedented understanding and yielded a cascade of scientific discoveries and new sub-specialties (microbiology, immunology, parasitology, and tropical medicine). the dawn of the antibiotic era with penicillin and streptomycin provided means to treat syphilis, staph infections, and tb. the development of a series of vaccines dramatically lowered the incidence of smallpox, pertussis, diphtheria, tetanus, rubella, measles, mumps, and polio. ddt seemed to furnish a means to abolish malaria and other insect-borne pathogens. by the s, therefore, scientific discoveries had provided effective weapons against many of the most prevalent infectious diseases. extrapolating from such dramatic developments, many concluded that it was reasonable to expect that communicable diseases could be eliminated one at a time until the vanishing point was reached. indeed, the worldwide campaign against smallpox provided just such an example when the who announced in that the disease had become the first ever to be eradicated by intentional human action. those who asserted the doctrine of the conquest of infection viewed the microbial world as largely static or only very slowly evolving. for that reason, there was little concern that the victory over existing infections would be challenged by the appearance of new diseases for which humanity was unprepared and immunologically naive. falling victim to historical amnesia, they ignored the fact that the last years even in the west had been punctuated by the appearance of a series of catastrophic new diseases: bubonic plague in , syphilis in the s, cholera in , spanish influenza in - . macfarlane burnet in this regard was typical. burnet was a founding figure in evolutionary medicine who acknowledged, in theory, the possibility of the emergence of new diseases as a result of mutation. but, in practice, he believed that such appearances are infrequent and that they occur only at such distant intervals as to occasion little concern. 'there may,' he wrote, 'be some wholly unexpected emergence of a new and dangerous infectious disease, but nothing of the sort has marked the last fifty years' ( ) . the notion of microbial fixity, that the diseases that we have are the ones that we will face, even underpinned the international health regulations adopted in (ihr ) , which specified that the three great epidemic killers of the th century were the only diseases requiring notification: plague, yellow fever, and cholera. the regulations gave no thought to what action would be required if an unknown but deadly and transmissible new microbe should appear ( , ) . if belief in the stability of the microbial world was one of the major articles of faith underpinning the eradicationists' vision, a second misplaced evolutionary idea also played a crucial role. this was the doctrine that nature was fundamentally benign. over time, eradicationists believed, the pressure of natural selection would drive all communicable diseases toward a decline in virulence. the principle was that excessively lethal infectious diseases would prevent their own transmission by prematurely destroying their hosts. the long-term tendency, the proponents of victory asserted, is toward commensalism and equilibrium. new epidemic diseases are virulent almost by accident as a temporary maladaptation, and they therefore evolve toward mildness, ultimately becoming readily treatable diseases of childhood. examples were the evolution of smallpox from variola major to variola minor; the transformation of syphilis from the fulminant 'great pox' of the th century into the slow-acting disease of today; and the transformation of classic cholera into the far milder el tor biotype. similarly, the doctrine held a priori that, in the family of four diseases of human malaria, the most virulent, i.e. falciparum malaria, was an evolutionary newcomer relative to the less lethal vivax, ovale, and malariae malaria, which were believed to be older and to have evolved toward commensalism. against this background, the standard textbook of internal medicine in the eradicationist era, the th edn of harrison's principles of internal medicine of , claimed that a feature of infectious diseases is that they 'as a class are more easily prevented and more easily cured than any other major group of diseases' ( , ) . the most fully elaborated and most cited theory of the new era was the 'epidemiologic transition' or 'health transition' theory represented by abdel omran, professor of epidemiology at johns hopkins, in and refined by him in and . omran's theory of the transition was an account of the encounter of human societies with disease in the modern period. according to omran and his followers in such journals as the health transition review, humanity has passed through three eras of modernity in health and disease. although omran is ambiguous about the precise chronology of the first era, the 'age of pestilence and famine,' it is clear that it lasted until the th century in the west and was marked by malthusian positive checks on demography: epidemics, famines, and wars. there followed the 'age of receding pandemics' that extended from the mid- th century until the early th in the developed west and until later in non-western countries. during this period there was a declining mortality from infectious diseases in general and from tb in particular. finally, after world war i in the west and after world war ii in the rest of the globe, humanity entered the 'age of degenerative and man-made diseases.' whereas in the earlier stages of disease evolution, social and economic conditions played the dominant role in determining health and the risk of infection, in the final phase medical technology and science played a major part. in this period, mortality and morbidity from infectious diseases have been progressively replaced by the rise of degenerative diseases such as cardiovascular disease, cancer, diabetes, and metabolic disorders, by man-made diseases such as occupational and environmental illnesses, and by accidents ( ) ( ) ( ) . adopting the perspective of 'health transition' theory, us surgeon general julius b. richmond announced in that infectious diseases were simply the 'predecessors' of the degenerative diseases that succeed and replace them. the course of nature, in his view, was simple, unidirectional, and benign ( ) . if memory of the power of public health and science provided a major impetus to overconfidence, forgetfulness also played a vital role. us surgeon general william steward reported in that the time had come to 'close the book on infectious diseases.' this view was profoundly eurocentric. even as medical experts in europe and north america snowden Á emerging and reemerging diseases r the authors journal compilation r blackwell munksgaard immunological reviews / declared final victory, infectious diseases remained the leading cause of death worldwide, and nowhere more disastrously than in the poorest and most vulnerable countries of africa, asia, and latin america. while the tb sanatoria were closing their doors in the developed north, the disease continued its ravages in the south. indeed, the disease continued to ravage the marginalized underclasses of the north itself: the homeless, prisoners, intravenous drug users, immigrants, and racial minorities. as paul farmer has argued, tb was emphatically not disappearing; it was just that the bodies it affected were either distant or hidden from sight ( , ) . indeed, in the best estimates suggest that there are more people ill with tb today than at any time in human history and that nearly two million will die of it during the course of the year ( , ) . ultimately, by the early s, the eradicationist position became untenable. rather than witnessing the rapid fulfillment of the prediction that science and technology would eliminate all infectious diseases from the globe, the industrial west discovered that it remained painfully vulnerable and to a degree that had seemed unimaginable. the decisive event, of course, was the arrival and upsurge of human immunodeficiency virus (hiv)/acquired immunodeficiency syndrome (aids). aids was first recognized as a new disease entity in , and its etiologic pathogen was identified in . by the end of the decade, it was clear that hiv/aids embodied everything that the eradicationists had considered unthinkable. aids was a new infectious disease for which there was no cure, it reached the industrial world as well as developing countries, and it unleashed in its train a series of exotic additional opportunistic infections. furthermore, it had the potential to become the worst pandemic in history as measured not only by mortality and suffering but also by its profound social, economic, and security consequences. from the front lines of the battle against aids, a series of voices sounded the alarm in the s about the severity of the new threat. most famous of all was the case of the us surgeon general c. everett koop, who became the chief federal spokesman on the disease. in he produced the brochure understanding aids and took the pioneering step of having it mailed to all million households in the nation ( ) . working in greater obscurity in sub-saharan africa, peter piot, who later directed unaids, warned in that aids in africa was not a 'gay plague' but an epidemic of the general population. he warned that it was transmitted by heterosexual as well as homosexual intercourse and that in fact it affected women more readily than men. the warnings of the s, however, were confined to the issues of aids: they did not directly confront the larger issue of eradicationism or announce a new era in medicine and public health. that task fell first to the national academy of science's institute of medicine (iom) and its landmark publications on emerging diseases that began in with emerging infections: microbial threats to health in the united states ( ) . once raised by the iom, the cry of alarm was taken up widely and almost immediately: by the centers for disease control and prevention (cdc), which devised its own response to the crisis in and founded a new journal emerging infectious diseases devoted to the issue; by the national science and technology council (nstc) in ; and by of the world's leading medical journals that agreed to take the unprecedented step by which each devoted a theme issue to emerging diseases in january , which they proclaimed 'emergent diseases month' ( ) ( ) ( ) . in , in addition, president bill clinton ( ) issued a fact sheet entitled 'addressing the threat of emerging infectious diseases' in which he declared them 'one of the most significant health and security challenges facing the global community.' there were also highly visible hearings on emerging infections in the us congress ( ) . in opening those hearings before the senate committee on labor and human resources, senator nancy kassebaum, the committee chairperson, noted, new strategies for the future begin with increasing the awareness that we must re-arm the nation and the world to vanquish enemies that we thought we had already conquered. these battles, as we have learned from the year experience with aids, will not be easy, inexpensive, nor quickly resolved. ( ) finally, to attract attention at the international level, the who, which had designated april of each year world health day, declared that the theme for was 'emerging infectious diseases -global alert, global response' with the lesson that in a global village, no nation is immune ( ) . in addition to the voices of scientists, elected officials, and the public health community, the popular press gave extensive coverage to the new and unexpected danger, especially when the lesson was driven home by three events of the s that captured attention worldwide. the first was the onset of a large-scale epidemic of asiatic cholera in south and central america, beginning in peru in and rapidly spreading across the continent until cases and deaths were reported in countries ( ) . since the americas had been free of the disease for a century, the arrival of the unwelcome visitor reminded the world of the fragility of painfully won advances in public health. because cholera is transmitted by the contamination of food and water by fecal matter, it is a 'misery thermometer' -an infallible indicator of societal neglect and substandard living conditions ( ) . its outbreak in the west late in the th century, therefore, caused shock and a sudden awareness of unexpected danger. indeed, the press informed its readers of the 'dickensian slums of latin america,' where the residents of lima and other cities drew their drinking water directly from the 'sewage-choked river rimac' and similarly polluted sources ( , ) . who director-general hiroshi nakajima proclaimed the south american epidemic an 'emergency situation. ' the second news-catching event in the matter of epidemic diseases was the outbreak of plague in the indian states of gujarat and maharashtra in september and october . the final toll for the epidemic was limited - cases and deaths were reported ( ) . nevertheless, the news that plague had broken out in both bubonic and pneumonic forms unleashed an almost biblical exodus of hundreds of thousands of people from the industrial city of surat. it cost india an estimated $ . billion in lost trade and tourism, and it sent waves of panic around the world. the disproportionate fear, as the new york times explained, was due to the fact that the very word plague was explosively charged. it evoked cultural memories of the black death that killed a quarter of the population of europe in the th century. india's plague, the paper continued, 'is a vivid reminder that old disease, once thought to have been conquered, can strike unexpectedly anytime, anywhere' ( ) . the third major epidemic shock of the s was an outbreak of the frightening disease of ebola hemorrhagic fever at the city of kikwit, zaire (now democratic republic of the congo), in . cholera claimed international attention because of the numbers of those it afflicted, even though it had a low case fatality rate if treated early. plague demanded attention because of its all too familiar potential. ebola, by contrast, did not inspire terror by giving rise to a major epidemic: it infected only people between january and july . nor did it create fear because of historical memories of disaster since it was a new disease first recognized in . nevertheless, ebola set off a tidal wave of fear -a 'modern nightmare' in the words of le monde -across the globe. the reasons were that it dramatically revealed the lack of preparedness of both industrial and developing nations to deal with a public health emergency. it ignited primordial western fears of the jungle and of untamed nature, and it fed on racial anxieties about 'darkest' africa. as a result, a prominent aspect of the kikwit outbreak was its capacity to generate what the journal of infectious diseases termed 'extraordinary' and 'unprecedented' press coverage that amounted at times to the commercial 'exploitation' of human misery and a 'national obsession' ( ) . descending onto the banks of the kwilu river, the world's tabloids stressed in vivid hyperbole that ebola was a zoonotic disease that had sprung directly from the jungles of africa as a result of the encounter between native charcoal burners and monkeys and now threatened the west. in the revealing headline of the daily telegraph of sydney, 'out of the jungle a monster comes' ( ) . even the most legitimate investigators, however, were disturbed to discover that ebola had eluded public health attention for weeks between the death of the index case on january and the notification of the international community on april , despite the fact that the disease had left clusters of severely ill and dying patients in its train. with such a porous surveillance network in place, ebola aroused the fear that it might spread unnoticed km from kikwit to kinshasa, and then throughout the world by means of the zairian capital's intercontinental airport. there the virus could be loaded on board as 'a ticking, airborne time bomb' ( ) . most of all, however, the kikwit outbreak commanded attention because ebola is almost invariably fatal and because its course in the human body is excruciating, dehumanizing, and dramatic. commenting on the scenes that he had observed in zaire, the author richard preston explained on television at the height of the outbreak that the mortality rate among sufferers was % and that there was no known remedy or prophylactic. he continued: the victims suffer what amounts to a full-blown biological meltdown. . . . when you die of ebola, there's this enormous production of blood, and that can often be accompanied by thrashing or epileptic seizures. and at the end you go into catastrophic shock and then you die with blood pouring out of any or all of the orifices of the body. and in africa where this outbreak is going on now, medical facilities are not all that great. i've had reliable reports that doctors . . . were literally struggling up to their elbows in blood -in blood and black vomit and in bloody diarrhea that looks like tomato soup, and they know they're going to die. ( ) in combination with the announcement by scientists that the world was highly susceptible to new pandemics of just such infections, these events on three continents generated hordes, and of nature exacting its revenge for human presumption. as forrest sawyer reported on abc news, 'once the western world thought it was safe from these invisible killers. not anymore. we are now biologically connected in a web or a net.' in addition, there was an outpouring of films devoted to the possibility of pandemic disaster such as wolfgang petersen's thriller outbreak and of widely read books on the same theme, including richard preston's best-seller, the hot zone; laurie garrett, the coming plague: newly emerging diseases in a world out of balance; and william close, ebola. in the words of david satcher, director of the cdc, the result was the 'cnn effect' -the perception by the public that it was at immediate risk even at times when the actual danger was small ( ) . in this climate of anxiety, the term 'emerging and reemerging diseases' was coined for the iom by joshua lederberg, winner of the nobel prize for medicine, to mark a new era. lederberg defined these disease entities as follows: 'emerging infectious diseases are diseases of infectious origin whose incidence in humans has increased within the past two decades or threatens to increase in the near future' ( ) . emerging diseases were those that, like aids and ebola, were previously unknown to have afflicted humans; reemerging diseases, such as cholera and plague, were familiar scourges whose incidence was rising, or whose geographical range was expanding. lederberg's purpose in devising a new category of diseases was to give notice that the age of euphoria was over. instead of receding to a vanishing point, he declared, communicable diseases 'remain the major cause of death worldwide and will not be conquered during our lifetimes . . . we can also be confident that new diseases will emerge, although it is impossible to predict their individual emergence in time and place' ( ) . indeed, the contest between humans and microbes was a darwinian contest with the advantage tilted toward the microbes. the stark message of the iom was that, far from being secure from danger, the united states and the west were at greater risk from contagious and epidemic diseases than at any time in history. an important reason for this new vulnerability was the legacy of eradicationism itself. the belief that the time had come to close the books on infectious diseases had produced a pervasive climate that critics labeled variously as 'complacency,' 'optimism,' 'overconfidence,' and 'arrogance.' the conviction that victory was imminent had led the industrial world to premature and unilateral disarmament. assured by a consensus of the leading medical authorities for years that the danger was past, federal and state governments in the united states dismantled their public health programs dealing with communicable diseases and slashed their spending. at the same time, investment by private industry on the development of new vaccines and classes of antibiotics dried up, the training of health care workers failed to keep abreast of new knowledge, vaccine development and manufacture were concentrated in fewer laboratories, and the discipline of infectious diseases struggled to attract its aliquot share of research funds and of the best minds. at the nadir in , the united states spent only $ million for infectious disease surveillance as public health officials prioritized other concerns -chronic diseases, substance abuse, tobacco use, geriatrics, and environmental issues. for these reasons, the assessment of american preparedness to face the challenges of the new era was disheartening. in the words of the cdc in : the public health infrastructure of this country is poorly prepared for the emerging disease problems of a rapidly changing world. current systems that monitor infectious diseases domestically and internationally are inadequate to confront the present and future challenges of emerging infections. many foodborne and waterborne disease outbreaks go unrecognized or are detected late; the magnitude of the problem of antimicrobial drug resistance is unknown; and global surveillance is fragmentary. ( ) more bluntly, michael osterholm, the minnesota state epidemiologist, informed congress in that, 'i am here to bring you the sobering and unfortunate news that our ability to detect and monitor infectious disease threats to health in this country is in serious jeopardy. . . . for twelve of the states or territories, there is no one who is responsible for food or water-borne disease surveillance. you could sink the titanic in their back yard and they would not know they had water' ( ) . a striking example of the effects of complacency on infectious disease is the case of tb in new york city. tb had once been the leading cause of death in the city, but improvements in hygiene and education, followed by the discovery of streptomycin, led to the conviction by the middle of the th century that the disease was on the verge of being entirely conquered. as a result, funding was diverted, and demonstrably effective tb programs were dismantled although the social determinants of the disease worsened dramaticallyimmigration, crowding, homelessness, and rates of incarceration. meanwhile, hiv/aids continued to provide large numbers of patients with compromised immunity. as a result, the risk of infection increased, while access to health care became increasingly difficult, and the city experienced a remarkable and entirely preventable resurgence of the 'white plague,' primarily among african american and hispanic residents. between and , the numbers of cases tripled, while drug resistance developed as a significant additional problem. new york city led the way in a national resurgence of tb as cases increased by % between and . overweening confidence led directly and rapidly to a local epidemic and a partial reversal nationally of decades of tireless campaigning ( ) . if the experience of the united states with tb suggests how fragile advances in health remained even in the industrial world, the situation in developing countries was still more disquieting. there, progress toward the germ-free eden during the eradicationist era was nil. in david satcher's uncompromising observation, 'persons living in tropical climates are still as vulnerable to infectious disease as their early ancestors were' ( ) . the critique of years of hubris went deeper than just a protest against a decline in vigilance. in addition, the theorists of emerging diseases argued that, unnoticed by the eradicationists, society since world war ii had changed in ways that actively promoted the emergence and reemergence of epidemic diseases. one of the leading features most commonly cited was the impact of globalization in the form of the rapid mass movement of goods and populations. as william mcneill noted in plagues and peoples ( ) , the migration of people throughout history has been one of the most dynamic factors affecting the balance between microbes and man. humans are permanently engaged in a kind of war in which the social and ecological conditions that they create exert powerful evolutionary pressure on micro-parasites. by mixing gene pools and by providing access for microbes to populations of non-immunes living in conditions in which the microbes thrive, globalization gave microorganisms a powerful advantage. in the closing decades of the th century and the early years of the st, the speed and scale of this phenomenon amounted to a quantum leap, as . billion passengers boarded airplanes in ( , ) . in the words of the popular press, the daily movement of people around the globe by airplane means that a disease breaking out today in kikwit can arrive in new york, mumbai, and mexico city tomorrow. the numbers of voluntary travelers, moreover, are massively supplemented by millions of involuntary refugees and displaced persons in flight from warfare, famine, and religious, ethnic, or political persecution. for lederberg and the iom, these rapid mass movements have tilted the advantage in favor of microbes, 'defining us as a very different species from what we were years ago. we are enabled by a different set of technologies. but despite many potential defenses -vaccines, antibiotics, diagnostic tools -we are intrinsically more vulnerable than before, at least in terms of pandemic and communicable diseases' ( ) . after globalization, the second factor most frequently underlined was demographic growth, especially because this growth occurred in circumstances that were the delight of microorganisms and of the insects that often transmit them. in the postwar era, population has soared above all in the poorest and most vulnerable regions of the world, with the global urban population growing at four times the rate of the rural. its hallmark has been wholesale, chaotic, and unplanned urbanization, led by the resource-poor nations of sub-saharan africa, which is the most rapidly urbanizing region on the planet ( ) . the results have been escalating poverty, widening social inequality, the birth of 'megacities' exceeding million inhabitants, and the spawning of teeming peri-urban slums without sanitary, educational, or other infrastructures. such places were ready-made for ancient diseases to expand, as cholera demonstrated in the shantytowns and barrios of cities like lima, mexico city, and rio de janeiro, where millions lived without sewers, drains, secure supplies of drinking water, or appropriate waste management. already in the th century, cholera had flourished in the conditions created in european cities by rapid and unplanned urbanization. in the final decades of the th century and the start of the st, a much larger process on a global scale reproduced in the cities of africa, asia, and latin america the anomalous sanitary conditions propitious for cholera ( ) . another clear indication of socio-economic conditions in these new urban ecosystems is the appearance of trench fever (bartonella quintana) among the inhabitants of homeless shelters in north american cities. trench fever first emerged in the filth and crowding of soldiers in the trenches of the western front in the first world war, when millions of combatants were infected by the lice that covered their bodies. bartonella quintana, however, had never been documented apart from the vermin and the grime of wartime. the reemergence of the disease in urban america is therefore a clear measure of the insalubrious conditions of marginalized populations among the urban poor ( , ) . here too in urban poverty were the social determinants that made possible the global pandemic of dengue fever that began in and has continued unabated until today, when . billion people are at risk every year and - million people are infected. dengue is the ideal type of an emerging disease. an arborovirus transmitted primarily by the highly urban, daybiting, and domestic aedes aegypti mosquito, dengue thrives in crowded tropical and semi-tropical slums whenever there is standing and unregulated water. it breeds abundantly in gutters, uncovered cisterns, unmounted tires, stagnant puddles, and plastic containers, and it takes full advantage of societal neglect and the absence or cessation of vector control programs. particularly important for the theorists of 'emerging diseases' was the manner in which dengue demonstrated the hollowness of the reassuring dogma that infectious diseases evolve inexorably toward commensalism and reduced virulence. the dengue virus is a complex of four closely related serotypes (den- , den- , den- , and den- ) that have been known to infect humans since the th century. until , however, dengue infections in any geographical area were caused by a single virus that gave rise to a painful illness marked by fever, rash, headache behind the eyes, vomiting, diarrhea, prostration, and joint pains so severe that the infection earned its nickname 'break-bone fever.' but 'classical' dengue was a self-limiting disease that was followed by lifelong immunity. the movement and mobility of populations, however, have allowed all four serotypes to spread indiscriminately around the globe, so that for the first time individuals who have already experienced infection with one dengue virus can subsequently be infected with one or more of the others, as there is no crossover immunity from one serotype to another. through mechanisms that are still imperfectly understood, the disease is much more severe in patients suffering re-infections with different serotypes. instead of becoming milder, therefore, dengue has become a growing threat, giving rise to far more frequent outbursts and to sudden, devastating epidemics in which large numbers of patients suffer the severe and often lethal complications of dengue hemorrhagic fever (dhf) and dengue shock syndrome (dss) that were once unknown. in the americas, the first modern epidemic of dengue fever broke out in in cuba, producing cases, of whom suffered dhf and dss ( ) . moreover, since the dengue vectors a. aegypti and aedes albopictus are present in the united states, scientists at the national institute of allergy and infectious diseases (niaid), such as its director anthony fauci, have noted that dengue fever has broken out in both hawaii and puerto rico, and that they see no inherent reason it could not include the continental united states in its ongoing global expansion ( ) . dengue therefore demonstrates the following important evolutionary lessons: (i) infectious diseases that do not depend on the mobility of their host for transmission (because they are vector-borne, waterborne, or foodborne) are not under selective pressure to become less virulent; (ii) overpopulated and unplanned urban or peri-urban slums provide ideal habitats for microbes and their arthropod vectors; and (iii) modern transportation and the movements of tourists, migrants, refugees, and pilgrims facilitate the process by which microbes and vectors gain access to these ecological niches. paradoxically, the very successes of modern medical science also prepared the way for the emergence of new infections. by prolonging life, medicine gives rise to ever larger numbers of elderly people with compromised immune systems. as part of this process, significant numbers of immunocompromised populations have appeared at earlier ages as well-diabetics, cancer and transplant patients undergoing chemotherapy, and aids patients whose lives have been radically extended by antiretroviral treatment. furthermore, such people are frequently concentrated in settings where the transmission of microbes from body to body is amplified, such as hospitals, facilities for the elderly, and prisons. the proliferation of invasive procedures has also increased the opportunities for such diseases. modern nosocomial infections emerged in these conditions, and have become a major problem of public health as well as an ever growing economic burden. of these infections, the so-called 'superbug' staphylococcus aureus -the leading cause of nosocomial pneumonia, of surgical site infections, and of nosocomial bloodstream infections -is the most important and widespread. a recent study notes that in the united states by : each year approximately two million hospitalizations result in nosocomial infections. in a study of critically ill patients in a large teaching hospital, illness attributable to nosocomial bacteria increased intensive care unit stay by days, hospital stay by days, and the death rate by %. an earlier study found that postoperative wound infections increased hospital stay an average of . days. ( ) a further threatening byproduct of the advance of medical science is the development of ever increasing antimicrobial resistance. already in his nobel prize acceptance speech, alexander fleming, who discovered penicillin, the first antibiotic, issued a prophetic warning. penicillin, he advised, needed to be administered with care, because the bacteria susceptible to it were likely to develop resistance. the selective pressure of so powerful a medicine would make it inevitable. echoing fleming's warning, the emerging diseases theorists argue that antibiotics are a 'non-renewable resource' whose duration of benefit is biologically limited. by the late th century, this prediction was reaching fulfillment. on the one hand, the discovery of new classes of antimicrobials had slowed to a trickle, especially in a market in which profit margins are compressed by competition, by regulations requiring large and expensive clinical trials before approval, and by the low tolerance for risk on the part of regulatory agencies charged with the safety of the public. on the other hand, while antiinfective development stagnates, many microorganisms have evolved extensive resistance. as a result, in one telling metaphor, physicians are rapidly emptying their quiver, and the world stands poised to enter the postantibiotic era ( ) . some of the most troubling examples of the emergence of resistant microbial strains are the emergence of plasmodia that are resistant to all synthetic antimalarials, of s. aureus that is resistant both to penicillin and to methycillin (mrsa), and of strains of mycobacterium tuberculosis that are resistant not only to first-line medications (mdr-tb) but to second-line medications as well (xdr-tb) ( ) . antimicrobial resistance has become a global crisis, and many anticipate the early appearance of strains of hiv, tb, staph a, and malaria that are not susceptible to any available therapy. in part the problem of antimicrobial resistance is a simple result of darwinian evolution. as a rand corporation study ( ) notes, there are tens of thousands of viruses and species of bacteria that are capable of infecting human beings, and many of them replicate and evolve billions of times in the course of a single human generation. evolutionary pressures, in this context, work to the long-term disadvantage of human beings. but unwise human actions have dramatically hastened the process. farmers spray crops with pesticides and fruit trees with antibiotics, and they add subtherapeutic doses of antibiotics such as virginiamycin and avoparcin wholesale to animal feed to prevent disease, promote growth, and increase the productivity of chickens, pigs, and feedlot cattle. indeed, half the world output of antimicrobials by tonnage is used in agriculture ( ) . at the same time, the popular confidence that microorganisms will succumb to a chemical barrage has led to a profusion of antimicrobials in domestic settings where they serve no purpose ( ) . physicians, pressured to give priority in clinical settings to the immediate risk of individual patients over the long-term interest of the species and to meet patients' expectations, have succumbed to profligate prescribing fashions, administering antibiotics even for non-bacterial conditions for which they are unnecessary or entirely useless. the classic case in this regard is the pediatric treatment of otitis media (or middle ear infection), for which the overwhelming majority of practitioners in the s prescribed antibiotics, even though two-thirds of the children derived no benefit from the medication. widespread possibilities of self-medication in countries with few regulations or through opportunities created by the internet amplify the difficulties. in the case of diseases such as malaria and tb that require a long and complicated therapeutic regimen, there is also the issue of patients who interrupt their treatment after the alleviation of their symptoms instead of persevering until their condition is cured. here the problem is not the overuse but the underuse of antibiotics. sometimes described as simple non-compliance by patients, the issue in fact raises complex questions of education, poverty, and lack of access to health care. here the who strategies of dots (directly observed treatment short course) and dots-plus are helpful but cannot solve the underlying problems. a further issue raised by the new era was the overly rigid conceptualization of disease by the eradicationists, who drew too sharp a distinction between chronic and contagious diseases. infectious diseases, it became clear during the s, are a more expansive category than scientists previously realized because many diseases long considered noninfectious in fact have infectious origins. in demonstrating these causal connections, the decisive work was that of the australian nobel laureates barry j. marshall and robin warren with regard to peptic ulcers in the s. peptic ulcers are a significant cause of suffering, cost, and even death, as one american in develops one during the course of a life time, over one million people are hospitalized by them every year, and die. marshall noted in his acceptance speech for the nobel prize in , however, that the chronic etiology of peptic ulcer in the s was universally accepted as scientific truth. in his words, 'i realized that the medical understanding of ulcer disease was akin to a religion. no amount of logical reasoning could budge what people knew in their hearts to be true. ulcers were caused by stress, bad diet, smoking, alcohol and susceptible genes. a bacterial cause was preposterous.' what marshall and warren were able to demonstrate, therefore, was a medical watershed. they proved, in part by means of an auto-experiment, that the bacterium helicobacter pylori was the infectious cause of the disease and that antibiotics rather than diet, lifestyle change, and surgery were the appropriate therapy ( ) . this insight led to the realization that many other non-acute diseases, such as certain forms of cancer, chronic liver disease, and neurological disorders, are due to infections. human papillomavirus, for instance, is thought to give rise to cervical cancer, hepatitis b and c viruses to chronic liver disease, campylobacter jejuni to guillain-barré syndrome, and certain strains of escherichia coli to renal disease ( , ) . there are indications as well that infections serve as an important trigger to atherosclerosis and arthritis, and there is a growing recognition that epidemics and the fear that accompanies them leave psychological sequelae in their wake, including posttraumatic stress ( , ) . this understanding of these processes is what some have termed finally, and most emphatically, the concept of emerging and reemerging diseases was intended to raise the most important threat of all -that the spectrum of diseases that humans confront is broadening with unprecedented and unpredictable rapidity. the number of previously unknown conditions that have emerged to afflict humanity since exceeds , with a new disease discovered on average more than once a year. the list includes such frightening names as hiv, hantavirus, lassa fever, marburg fever, legionnaires' disease, hepatitis c, lyme disease, rift valley fever, ebola hemorrhagic fever, nipah virus, west nile virus, sars (severe acute respiratory syndrome), bovine spongiform encephalopathy, avian flu h n , chikungunya virus, and group a streptococcus -the so-called 'flesh-eating bacterium.' skeptics argue that simply to list the diseases that have emerged since s gives the misleading impression that diseases are emerging at an accelerating rate. this impression, they suggest, is largely an artifact of heightened surveillance and improved diagnostic techniques rather than a new development. the who has countered that not only have diseases emerged at record rapidity as one would expect from the transformed social and economic conditions of the postwar world, but also that they gave rise between the years and to a record worldwide epidemic events ( ) . the most recent and comprehensive examination of the question ( ), published in february in nature, involved the study of emerging infectious disease (eid) 'events' between and , controlling for reporting effort through more efficient diagnostic methods and more thorough surveillance. the conclusion was that, 'the incidence of eid events has increased since , reaching a maximum in the s. . . . controlling for reporting effort, the number of eid events still shows a highly significant relationship with time. this provides the first analytical support for previous suggestions that the threat of eids to global health is increasing' ( ) . there are no rational grounds, the public health community concluded, to fail to expect that as diseases emerge in the future, some of them will be as virulent and as transmissible as hiv or the spanish influenza of / . discussion has therefore shifted dramatically from the question of whether new diseases will emerge and old ones resurge to the issue of how the international community can best prepare to face them. in the stark words of the us department of defense, 'historians in the next millennium may find that the twentieth century's greatest fallacy was the belief that infectious diseases were nearing elimination. the resultant complacency has actually increased the threat' ( ) . a major aspect of the official response to the challenge of emerging and reemerging diseases is that microbes now are regarded as threats to the security of states and to the stability of the international order. for the first time, therefore, not only public health authorities but also intelligence agencies and conservative think tanks have classified infectious diseases as a 'non-traditional threat' to national and global security. they assumed therefore the task of envisaging the future and the challenge that communicable diseases would play. here a turning point was the central intelligence agency (cia)'s national intelligence estimate (nie) for ( ) , which was devoted to the danger posed by disease and presented defense against epidemic diseases as a major security goal for the united states. as a document, nie - d ( ) was divided into four major sections: alternative scenarios, impact, implications, and discussion. in the first section, the cia attempted to outline three possible scenarios for the course of infectious diseases over the next years: (i) the optimistic contemplation of steady progress in combating communicable disease; to (ii) the forecast of a stalemate with no decisive gains either by microbes or by humans in their long war of attrition; and (iii) the consideration of the most pessimistic prospect of deterioration in the position of humans, especially if the world population continues, as seems probable, to expand and if megacities continue to spring up with their attendant problems of crowding, sanitation, and unprotected drinking water. unfortunately, the cia regarded the optimistic first case as extremely unlikely. the probable course of events, in its view, is that americans will die from infectious diseases every year or considerably more if a pandemic of influenza or of a still unknown disease occurs, if there is a dramatic decline in the effectiveness of antiretroviral treatments for hiv/aids. only toward the end of the years did the report foresee possible advances due to enhanced public health initiatives, the development of new drugs and vaccines, and economic development ( ) . against this background, the succeeding sections on 'impact' and 'implications' outlined a series of likely economic, social, and political results that would occur in the new age of increasing disease burdens. in the most afflicted regions of the world, such as sub-saharan africa, the report anticipated 'economic decay, social fragmentation, and political destabilization.' the international consequences of these developments would be growing struggles to control increasingly scarce resources, accompanied by crime, displacement, and the degradation of familial ties. disease, therefore, would heighten international tensions while it weakened forces, such as international peacekeepers, who might otherwise have played a larger role in controlling regional tensions. us or european military forces deployed abroad in support of humanitarian or other operations would be at high risk. because the economic and social consequences of increasing burdens of communicable diseases in the developing world are certain to impede economic development, the nie also predicted that democracy would be imperiled, that civil conflicts and emergencies would multiply, and that the tensions between north and south would deepen. three years later, motivated by the cia's report, an influential national security think tank, the rand corporation, turned to the intersection of disease and security when it attempted to provide 'a more comprehensive analysis than has been done to date, encompassing both disease and security' ( ) . in so doing, it envisaged even more somber probabilities than the cia in the new global environment. the rand corporation intelligence report the global threat of new and reemerging infectious diseases: reconciling u.s. national security and public health policy ( ) had two leading themes. the first was that in the postwar era there was a sharp decline in the importance of direct military threats to security. the second was that there is a corresponding rise in the impact of 'non-traditional challenges,' of which diseases are the major but inadequately recognized component. it has always been accepted, the report stressed, that diseases kill and undermine the quality of individual lives. in addition, it was essential to recognize that the transition to the era of emerging and reemerging diseases marked the opening of a period in which infectious diseases would profoundly affect the ability of states to function and to preserve social order. the most striking portion of the global threat of new and reemerging infectious diseases ( ) was its imagining of a probable scenario in which south africa could become the first modern state to fail specifically because of infectious diseases in general and the hiv/aids pandemic in particular. as the report explained, 'the contemporary hiv/aids crisis in south africa represents an acute example of how infectious diseases can undermine national resilience and regional stability.' in absolute numbers, south africa has the highest number of hiv-positive inhabitants in africa - . million people in , or % of the country's adult population. already, such extreme prevalence of the disease has pervasive impacts, affecting all aspects of south african security. but south africa is just emerging from the first phase of the aids pandemic and is therefore far from experiencing the full effects of the crisis, which even in the absence of resistance to antiretroviral therapy, is expected to produce patients with hiv and with full-blown aids by . in these circumstances, over a quarter of the economically active population will have the disease, causing severe skill shortages, creating poverty, destroying economic development, undermining participation in political life, and giving rise to more than two million orphans who will be impoverished, uneducated, and easily drawn into crime and prostitution. the effects will also be deeply felt in the military, the police, and the legal system, which will be severely deprived of manpower and unable to function just as social tensions deepened. 'the net effect,' it concluded, 'will be entirely negative for south africa's civil stability, possibly reducing the country to widespread social anarchy within the next five to twenty years.' this disturbing outcome, moreover, could be hastened by the public health policies of president thabo mbeki, who espoused the theories of the aids denier peter duesberg and rejected the link between the hiv virus and the disease. the point the rand corporation stressed most about south africa, however, was that it was simply a dramatic illustrative example. what was occurring there as a result of hiv/aids could happen without warning elsewhere. 'a crisis of similar proportions,' it explained, 'could therefore break out in any country at any time.' indeed, in the context of a growing danger of bioterrorist attack, such an outbreak could be launched intentionally. it was precisely this point -the growing vulnerability of all in the age of globalization -that led the world community, the european union, and individual nations to rearm in preparation for the inevitable threats to come. in the new climate of preparedness, the united states took a prominent role, beginning almost immediately in the aftermath of the iom report. in the cdc -the chief monitoring agency -drafted a strategic plan that it then updated in , while niaid -the principal basic research center -established a research agenda. both agencies' plans were endorsed by the white house, where the nstc under the chairmanship of vice president al gore issued a 'fact sheet: addressing the threat of emerging infectious diseases,' which in turn was backed by a presidential decision directive of june , . the result, as gore explained, was the first national policy by the united states to confront the international problem of infectious diseases ( ) . the essential starting point of the plan envisaged by the cdc, niaid, and the white house was the iom's description of the darwinian struggle under way between humans and microbes. in the iom's analysis of that struggle, microbes possess formidable advantages. they outnumber human beings a billionfold, they enjoy enormous mutability, and they replicate, in lederberg's estimate, a billion times more quickly than man, with generations measured in minutes rather decades. in terms of natural evolutionary adaptation, therefore, microbes are genetically favored to win the contest. in lederberg's observation, 'pitted against microbial genes, we have mainly our wits' ( ) . taking this iom analysis as its starting point, the american response to the new challenge is best seen as the attempt to organize and deploy human wit, backed by newly found financial resources, to counter the microbial genetic challenge ( ) . the white house 'fact sheet' declared in clear alarm that, 'the national and international system of infectious disease surveillance, prevention, and response is inadequate to protect the health of u.s. citizens.' to remedy the situation, the white house established six policy goals, as follows: . strengthen the domestic infectious disease surveillance and response system, both at the federal, state, and local levels and at ports of entry into the united states, in cooperation with the private sector and with public health and medical communities. . establish a global infectious disease surveillance and response system, based on regional hubs and linked by modern communications. . strengthen research activities to improve diagnostics, treatment, and prevention, and to improve the understanding of the biology of infectious disease agents. . ensure the availability of the drugs, vaccines, and diagnostic tests needed to combat infectious diseases and infectious disease emergencies through public and private sector cooperation. . expand missions and establish the authority of relevant us government agencies to contribute to a worldwide infectious disease surveillance, prevention, and response network. . promote public awareness of eids through cooperation with non-governmental organizations and the private sector ( ) . in pursuit of goals , , and , nih funding was doubled between and . niaid established a research agenda to develop new weapons to combat epidemic diseases, giving rise to an explosion in knowledge while publications on infectious diseases burgeoned. indeed, the agency director, anthony s. fauci, claimed in that hiv/aids in particular has become the most extensively studied disease in human history. niaid's priority is the development of safe and effective vaccines and medications to combat hiv/aids, malaria, tb, and influenza. to that end, it has evaluated over hiv vaccine candidates, funded clinical trials, and developed antiretroviral medications. in the field of malariology, it has completed the genomic sequencing of plasmodium falciparum and of the feared malaria vector anopheles gambiae with the expectation that this genetic knowledge is the first step toward the capacity to design anti-malarial drugs, vaccines, and pesticides. the work of the federal agency, moreover, has been complemented by the work of private organizations such as the bill and melinda gates foundation, and university laboratories ( ) . at the same time that niaid stressed basic research, the cdc developed a defensive strategy against emerging pathogens in compliance with goal of the president's directive. the cdc articulated its plan in two seminal works published in and . there it articulated its objectives in four principal areas: surveillance; applied research; prevention and control; and the enhancement of the infrastructure and trained personnel needed for diagnostic laboratories at the federal, state, local, and international levels. in addition, the atlanta-based agency strengthened its links with the international public health community and with other surveillance agencies such as the fda and the department of defense. it enhanced its capacity to respond to outbreaks, and it launched the journal emerging infectious diseases as a forum to pool information on communicable diseases. it sponsored a series of major international conferences on the topic of emerging and reemerging diseases, beginning in with the participation of representatives from all states and countries. the cdc initiatives were widely regarded as a model for the establishment of surveillance and response capabilities in other countries as well ( , ) . at the global level, the un and its agency who also took major steps to strengthen international preparedness for the ongoing siege by microbial pathogens. a first step was the creation in of the disease-specific organization unaids with the function of raising awareness, mobilizing resources, and monitoring the pandemic. funding levels in the fight against the disease increased from $ million in to nearly $ billion a decade later ( ). a further step was that like the united states, the united nations announced that it regarded infectious diseases as threats to international security. in acknowledgement of this new development, the security council took the unprecedented step in june of devoting a special session to the hiv/aids crisis. the session adopted a 'declaration of commitment on hiv/aids: global crisis -global action.' the declaration declared the global epidemic a 'global emergency and one of the most formidable challenges to human life and dignity' ( ) . five years later, in june , the general assembly reaffirmed its commitment to the campaign, and adopted the ' political declaration on hiv/aids,' whose chief goal was the establishment of national campaigns to improve access to care and treatment ( ). a third step was the establishment of a new set of international sanitary regulations -ihr ( ) -to replace the outdated ihr ( ). whereas the old framework was disease-specific and required notification only in the event of plague, yellow fever, and cholera, the new rules required notification for any 'public health emergency of international concern,' thereby including unknown pathogens and emerging infections. the regulations specified the nature of the 'events' that should trigger international concern. they also committed all of the who member states to improve their capacity for surveillance and response and to designate 'national ihr focal points' as the units responsible for providing notification while requiring, in exchange, that the who provide assistance to member states in fulfilling their obligations ( , ) . in addition, recognizing that microbes do not acknowledge political frontiers, ihr ( ) called for effective responses wherever necessary to contain an outbreak on the basis of realtime epidemiological evidence instead of concentrating on taking defensive measures at international borders. finally, the who organized a rapid response capacity with the necessary supporting infrastructure. this was the global outbreak alert and response network (goarn), which was established in with the goal of ensuring that even most resource-poor countries would have access to the experts and resources needed to respond to an epidemic emergency. to that end, goarn pooled the resources of countries and organized experts in the field. in addition, it stockpiles vaccines and drugs, and supervises their distribution during epidemic events. between its founding and , goarn responded to outbreaks and attempted to learn from experience by establishing protocols to standardize such matters as field logistics, security, communication, and the deployment of field teams ( ). in addition to goarn, the who set up surveillance systems specifically designed to deal with pandemic influenza, which the un agency determined as its most feared security threat. these disease-specific networks are (i) the global influenza surveillance network, which provides recommendations twice a year on the appropriate vaccine for the subsequent influenza season by collecting samples from patients in countries and forwarding them to who collaborating laboratories for analysis, and (ii) flunet, which compiles the surveillance data thus collected to establish a global real-time early-alert system for the disease ( , ) . in practice, the first test of the effectiveness of the new structures was the sars pandemic of / -the first major emerging disease threat of the st century. after first appearing in the chinese province of guangdong in november , it erupted as an international health threat in march , when the who received notification and declared a global travel alert. between march and the declaration on july that the disease had been contained, sars affected people, caused deaths, brought international travel to a halt in entire regions, and cost $ billion in gross expenditure and business losses to asian countries alone. as retrospective studies have demonstrated, sars presented many of the features that most severely expose the vulnerabilities of the global system: sars is a respiratory disease capable of spreading from person to person without a vector; it has an asymptomatic incubation period of more than a week; it generates symptoms that closely resemble those of other diseases; it takes a heavy toll on caregivers and hospital staff; it readily spreads unobserved aboard aircraft; and it has a case fatality rate of %. at the time this new disease appeared, moreover, its causative pathogen (sars-associated coronavirus) was unknown, and there was neither a diagnostic test nor a specific treatment. for all of these reasons, it dramatically confirmed the iom's prediction that all countries were more vulnerable than ever to eids. sars demonstrated no predilection for any region of the globe and was no respecter of prosperity, education, technology, or access to health care. indeed, after its outbreak in china, sars spread by airplane primarily to affluent cities such as singapore, hong kong, and toronto, where it struck relatively prosperous travelers and their contacts, hospital workers, patients, and hospital visitors, rather than targeting the poor and the marginalized. more than half of the recognized cases occurred in well-equipped and technologically advanced hospital settings such as the prince of wales hospital in hong kong, the scarborough hospital in toronto, and the tan tock seng hospital in singapore ( , , ) . in terms of response to the crisis, the sars outbreak demonstrated and vindicated the reforms taken on both the national and international levels. after the debacle of chinese obfuscation at the start of the epidemic, national governments cooperated fully with ihr ( ). the world's most equipped laboratories and foremost epidemiologists, working in realtime collaboration via the internet, succeeded, with unprecedented speed, in identifying sars-cov in just weeks. at the same time the newly created goarn, together with such national partners as the canadian public health intelligence network, the cdc, and the who global influenza network, took rapid action to issue global alerts, monitor the progress of the disease, and supervise containment strategies before the disease could establish itself endemically. ironically, given the high-tech quality of the diagnostic and monitoring effort, the containment policies were based on traditional methods dating from the public health strategies against bubonic plague by the th century and the foundation of epidemiology as a discipline in the th. these measures were case tracking, isolation, quarantine, the cancellation of mass gatherings, the surveillance of travelers, recommendations to increase personal hygiene, and barrier protection by means of masks, gowns, gloves, and eye protection ( ) . although sars affected countries and every continent, the containment operation coordinated by goarn successfully limited the outbreak overwhelmingly to hospital settings with only sporadic community involvement, so that by july the who could announce that the pandemic was over. although sars tested the newly established global defenses against emerging diseases and the protective ramparts withstood the challenge, doubts relentlessly surfaced. the chinese policy of concealment between november and march had placed international health in jeopardy and revealed that even a single weak link in the response network could undermine the ihr ( ) system. indeed, resourcepoor countries that were compliant with the new framework of obligations nonetheless found it difficult or impossible to maintain the surveillance effort for the full -month duration of the emergency. still more tellingly, it was also clear that a major factor in the containment of sars was simple good fortune. the world was lucky that sars is spread by droplets and therefore requires extended contact for transmission, unlike classic airborne diseases such as influenza and smallpox. it was, relatively, much easier to contain, because except in the infrequent and still poorly understood case of so-called 'super shedders,' it is not readily communicable from person to person. as poorly transmissible as it was, however, sars exposed the absence of 'surge capacity' in the hospitals and health care systems of the prosperous and well-resourced countries it affected. the events of thereby raised the specter of what might have happened had sars been pandemic influenza, and if it had traveled to resource-poor nations at the outset instead of mercifully visiting cities with well-equipped and well-staffed modern hospitals and public health care systems. furthermore, sars arrived in peacetime rather than in the midst of the devastation and the dislocations of war. in that respect, too, it did not repeat the challenge of the spanish lady of - . the physician paul caulford, who fought the sars epidemic in the front lines at scarborough hospital in toronto, raised these matters. in december , after the passing of the emergency, he reflected: sars must change us, the way we treat our planet, and how we deliver health care, forever. will we be ready when it returns? sars brought one of the finest publiclyfunded health systems in the world to its knees in a matter of weeks. it has unnerved me to contemplate what the disease might do to a community without our resources and technologies. without substantive changes to the way we manage the delivery of health care, both locally and on a worldwide scale, we risk the otherwise preventable annihilation of millions of people, either by this virus, or the next. ( ) at the end of the victory over sars, the nagging question therefore remains: even after the impressive efforts at rearmament since , how prepared is the international community for upcoming emerging diseases? have we been forever changed? the reforms introduced since the iom report in have been profound and important. indeed, the manner in which the international community responded to sars was innovative and, in the circumstances, highly successful. there is, however, a disconcerting sense of a systematic blindness in the responses -at all levels -to the crisis described by the iom, the cia, the rand corporation, the who, and the white house. what has been done has been necessary but probably far from sufficient. some of the issues raised by those who sounded the alarm have been forcefully addressed, but others have been largely ignored. the responses to date have fit into two chief categories, both of which are essential and both of which were evident during the sars pandemic. the first is reactive: the ability to respond rapidly and effectively to the outbreak of new epidemic threats. through a series of initiatives, the years since have witnessed the establishment of organized networks for gathering public health intelligence, of an international legal framework to structure emergency interventions, and of well equipped response teams of experts to contain and monitor outbreaks. if one were to compare outbreaks of infectious diseases to forest fires, the world has provided itself with surveillance satellites, advanced communications infrastructures, and a well-equipped fire department. one could question details of the response to sars, such as implementation lapses that risked the spread of the disease from the hospital environment into the community, but overall the world's 'dress rehearsal' demonstrated far-sighted planning and coordination beyond anything ever attempted before on an international scale. the second category of initiatives is proactive and scientific: the attempt to discover new weapons to attack microbial threats. after half a century of dwindling resources for the fight against infectious diseases, the scientific and public health communities have successfully aroused worldwide awareness of the threat to health and security. they have, at least initially, attracted new levels of funding for basic research from both public and private sources, and they have set research agendas. the result has been an explosion of knowledge, grants, and publications with priority given to genomic approaches to microbes and vectors, to the development of vaccines, and to the search for new medications and diagnostic tools. naturally there are grounds for criticism of various aspects of these initiatives. there is, for example, general agreement that overall levels of funding remain inadequate to the extent of the crisis and that after initial enthusiasm, governments have not continued to increase their support. there are also reasonable grounds for disagreement as to the relative distribution of research efforts, with discussion, for example, about the balance struck between research against hiv/aids and that against such other major diseases as malaria, tb, and pandemic influenza. some have also questioned whether developing vaccines is the right paradigm on all fronts. for example, should priority be given to those diseases for which the human immune response gives grounds for optimism thaton the basis of historical experience -a safe and effective vaccine can be developed (e.g. influenza and dengue)? or should other strategies be followed with respect to diseases for which the human immune response makes the development of a vaccine a far more arduous and unpredictable endeavor (e.g. cholera and malaria)? nevertheless, although there is no basis for false confidence, global research efforts have been galvanized, and major advances have been made in the field of infectious diseases in comparison with the early decades after world war ii. there is also a consensus that the effort to find vaccines and medicines is vital and that it must be enhanced in order to replenish the quivers of clinicians and public health officials. what is more troubling in principle is that there are also systematic blind spots -areas of danger raised by those who first sounded the tocsin regarding emerging diseases that have not been addressed at all or only marginally and sporadically. broadly speaking, the global community has chosen to address those issues for which scientific and technological responses are appropriate, while giving little sustained priority to what might be termed the social, economic, and environmental determinants of infectious disease. here there is a considerable irony. the founding figures of the modern concept of emerging and reemerging diseases such as joshua lederberg and robert shope stressed that epidemics do not strike societies randomly or in accord with the caprices of angry gods. diseases instead reflect the relationships that human beings establish with one another and with the natural and built environments. they then spread by taking advantages of the fault lines created by demography, poverty, environmental degradation, warfare, mass transportation, and societal neglect. the very beginning of the iom's discussion of the new dangers was the recognition that our new vulnerability is not accidental but is the logical result of the type of society that we have become. in defining this vulnerability in a keynote speech in , for instance, lederberg stated: to our disadvantage, we have crowding; we have social, political, economic, and hygienic stratification. we have crowded together a hotbed of opportunity for infectious agents to spread over a significant part of the population. this condensation, stratification, and mobility is unique, defining us as a very different species from what we were years ago. ( ) if our problem results from 'condensation, stratification, and mobility,' there is a disturbing silence in the government response. ironically, the various agencies -niaid, the cia, the department of defense -tasked by the presidential directive with augmenting american preparedness in the fight against infectious diseases neither mention socioeconomic factors nor elaborate a long-term strategy to address them. the call to action aroused the will to find new means to attack microbes and their vectors, and to contain disease outbreaks in human populations, but not to ameliorate the underlying conditions that have made modern societies vulnerable in the first place. three crucial examples illustrate the problem. the first is condensation or the press of overpopulation. clearly unrestrained demographic growth as the world population approaches seven billion strains all resources, degrades the environment, gives rise to the megacities and peri-urban slums where dengue, tb, and cholera thrive, drives populations to intrude into forests where they are exposed to new zoonotic infections, and overwhelms educational, housing, and hygienic infrastructures. here, the medical and public health communities agree, is a driving factor in the new human vulnerability to emerging diseases. the remedies, moreover, are already known, involving voluntary universal access for women to family planning education and technologies. one of the few forums even to raise the issue was the 'first international conference on women and infectious diseases' held in atlanta, february - , , where it was noted that, 'women's health, in and of itself, rarely has been at the forefront of international development programs or national health planning and policies' ( ) . in the field of infectious diseases, this lacuna is especially glaring because women are, as the conference stressed, more susceptible to infections than men, both for biological reasons and due to their caregiving roles and their relative burden of unemployment and poverty. women, moreover, suffer more serious complications from infectious diseases, above all during pregnancy. a second illustration is stratification, the burden of poverty and inequality. nearly all of the leading studies on emerging diseases regard poverty and its sequelae of poor diet, substandard housing, lack of education, and inadequate access to health care as one of the chief determinants of epidemic disease. poverty prevents people from taking measures to protect their own health, it undermines the immune system, it complicates access to safe water supplies, it leads to overcrowding in unhygienic housing, and it creates patterns of labor mobility and migration that compromise health. health care workers and clinicians recognize the link between inadequate resources and disease, with the result that many of the leading epidemic infections are widely termed 'diseases of poverty' ( ) . the issue therefore surfaces in who campaigns to combat the three most important contemporary epidemics: hiv/aids, malaria, and tb. as the report addressing poverty in tb control stated: poverty is the greatest impediment to human and socioeconomic development. the united nations and its specialized agencies are focusing on poverty reduction as a leading priority. in the health sector, poverty represents a principal barrier to health and health care and, consequently, the world health organization has committed to integrate the promotion of pro-poor policies throughout its work. ( ) the reduction of extreme poverty and hunger also form part of the un 'millennium development goals' to be achieved by . except for exhortation and moral suasion, however, it is not clear that the who has developed specific plans to tackle the problem of poverty as a primary determinant of public health, and the promotion of greater equality is entirely ignored. more strikingly, neither issue forms part of the strategic public health thinking of the united states. american analyses recognize poverty as a factor creating an environment favorable for infectious diseases, but they avoid both poverty and inequality as matters of practical health policy. here is the antithesis of the strategic recommendation of the south african pediatrician nulda beyers, who commented: the western cape is in some ways a model of tb epidemiology . . .. tb is almost non-existent in the white population, but in the black and coloured populations, where unemployment is running at %, and malnutrition and crowded slum housing are the norm, tb deaths can reach per . if i had to put my money on only one option -science or social upliftthere is no doubt that social uplift would have the bigger impact. ( ) poverty, moreover, reinforces both condensation and mobility. poverty creates a vicious downward spiral by interacting with population pressure because impoverished women are unable to practice effective family planning. the population explosion of the st century is based in the poorest regions of the planet. given a free and informed choice, privileged families in the industrial world limit their fertility. at the same time, however, poverty also augments vulnerability to infectious disease by setting in motion great streams of mobile people -the poor who become migrants, refugees, and displaced persons, and who then crowd into slums, mining compounds, refugee camps, and homeless shelters. these are people who are at disproportionately high risk of falling ill and of transporting their microbial burden with them. finally, there is the question of access to care. here the position of the leading figures in the campaign to recognize the importance of emerging and reemerging diseases is strangely contradictory. the iom examined the managed care revolution in the united states and the implications of for-profit medicine for the preparedness of the nation to face infectious diseases ( ) . by , managed care already enrolled million americans and therefore dominated health care delivery. the performance of the managed care revolution, however, did not inspire the iom. on the contrary, it produced a list of the major problems that, in its view, managed care created for public health. this list was lengthy and devastating. according to the iom, managed care creates severe public health difficulties because it does the following: (i) it places such strict controls on reimbursements that it becomes an impediment to effective collaboration with the public health community; (ii) it lowers costs by fostering management of infectious diseases by nonspecialists; (iii) it promotes the shift from inpatient to outpatient treatment, where there are neither the specialists nor the infrastructure to diagnose or contain infectious diseases; (iv) it proliferates bureaucratic complexities that complicate prompt response to disease outbreaks; (v) it reduces the commitment to training and research; and (vi) it encourages excessive antibiotic use ( ) . by leaving tens of million of people in the united states without insurance coverage and therefore without effective access to care, for-profit medicine effectively removes them from the disease surveillance network. to the extent that uninsured people avoid care entirely or seek it only at a late stage of their illness, the prompt information on which effective public health depends is undermined. in addition, excluding people from coverage drives them further into poverty and creates an underclass of the marginalized. finally, managed care relentlessly cuts costs by squeezing out of the system the surge capacity on which populations depend in the event of a disease outbreak. nevertheless, despite these observations, 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persisting importance of rhetoric and equity in health policy and outcomes date: - - journal: world med health policy doi: . /wmh . sha: doc_id: cord_uid: pogd p this editorial considers the persisting importance of rhetoric and equity in health policy analysis, implementation, and outcomes. it argues that employing social determinants of health, and intersectional and rhetorical frames, can improve life and health outcomes, as measured by morbidity and mortality. the pertinence of these frames with regard to the crises brought on by the covid‐ pandemic is discussed, and the plan for a special issue on disparties and covid‐ is announced. as italian political scientist giandomenico majone has noted, and we see playing out in the public response to the current pandemic, policy analysis, and the policy process it is meant to inform, have "less to do with proof and computation than with the process of argument" (majone, , p. ) . how such argument is articulated can importantly advance or stymie policy action, with tangible consequences for people's lives, as measured in the stark metrics of morbidity and mortality. and missteps or a failure to act in the current pandemic, as in other crises, disproportionately affect the already disadvantaged, exacerbating existing inequities (van dorn, cooney, & sabin, ) . the insight of the social determinants of health (sdoh) framework, as advanced by sir michael marmot, is that the conditions of daily life-"the conditions in which people are born, grow, live, work, and age; and inequities in power, money, and resources" are responsible for health inequities within and between countries (marmot, ) . considering questions of justice, and applying an intersectional framework in the context of health policy, can lead to structural innovation and have transformative effects for advancing equity, and thereby improve health outcomes in the society (hankivsky et al., ) . to that end, world medical & health policy continuously strives to encourage the examination of issues with the assistance of relevant frameworks such as those that employ social determinants, and intersectional and rhetorical lenses. world medical & health policy volume , issue is planned as a special issue devoted to understanding the differential impacts of covid- , consisting of both empirical and reflective articles considering the complex relationship between social determinants and health disparities in the context of the present-day pandemic. in the current issue of world medical & health policy volume , issue , skinner, strawhun, and gomes help us to conceptualize rhetorical arguments in the media comparing canadian and american health-care models over the last decade. identifying five main rhetorical frames, the authors find a "policy environment in which nuance and imperfection cannot be acknowledged, which forestalls problem solving." this article carries forward the important work featured in world medical & health policy volume , issue in december , which focused on the rhetoric of medical and health policy (lawrence & stabile, ) . in her study on social class and obesity in the current issue, buder notes that "obesity has a direct impact on occupational prestige for women, thus adding to the burden of obesity" in a study that "helps solidify the notion that obesity-related discrimination is most pronounced in females." while maternal and reproductive issues remain preeminent when topics of women's health are raised, world medical & health policy's virtual issue on women's health in global perspective also considers topics that transcend those confines, such as gender as a cross-cutting issue in food security in ethiopia (o'brien et al., ) , and refugee women's health in syria (samari, ) . here, too, buder's investigation highlights an issue of inequity that can have far-reaching consequences for women's health, well-being, economic viability, and political power in a way that is not exclusively tied to their reproductive role. using a content analysis approach, sajadi, kashi, and majdzadeh examine iran's general health policies (ghps) and find that equity emerges as a critical principle among core goals of "improving health outcomes, equity, quality, efficiency and effectiveness" and "offer a country-specific map to accelerate progress toward sustainable development" goals. schintler and mcneely also underscore the importance of equity to a "culture of health," which, they say, calls for "transforming dominant and encompassing patterns of stratification and mobility that generate and reflect societal disparities; it calls for the disruption of institutionalized societal patterns of haves and have-nots; it calls for a rewriting of the social contract and realizing ideals of equity and wellbeing in practice and application." in their consideration of the use of choice-based reminder cues in an mhealth study to improve tuberculosis (tb) treatment adherence among the urban poor in india, das gupta et al. implicitly address the role of what schintler and mcneely call these "institutionalized societal patterns of haves and have nots" by investigating "social stigma and lack of social support; … socioeconomics (the inability to travel to a health center due to travel time and cost and the opportunity cost of missing work) and … treatment and health-systems experiences." such factors, we know from social determinants of health and intersectionality policy frames, can often lead to inequities in outcomes, as evidenced by a heavier burden of morbidity and mortality, among impoverished or otherwise marginalized populations across an array of health areas globally. an intersectionality-based policy analysis framework: critical reflections on a methodology for advancing equity collaborative paths and contexts: an introduction to the special issue on rhetoric of medical and health policy evidence, argument and persuasion in the policy process the health gap: the challenge of an unequal world gender as a cross-cutting issue in food security: the nume project and quality protein maize in ethiopia syrian refugee women's health in lebanon, turkey, and jordan and recommendations for improved practice illness as metaphor and aids and its metaphors covid- exacerbating inequalities in the us remarks by president trump, vice president pence, and members of the coronavirus task force in press briefing military metaphors distort the reality of covid- key: cord- -gojbccmz authors: lee, seung-man; jeong, hyun-chul; so, wi-young; youn, hyun-su title: mediating effect of sports participation on the relationship between health perceptions and health promoting behavior in adolescents date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: gojbccmz the aim of this study was to verify the structural relationship between health perceptions, sports participation, and health promoting behavior in adolescents. a total of adolescents living in seoul, republic of korea, in , participated in this study. this study was conducted using a preliminary survey and a main survey. in the preliminary survey, the reliability and validity of the scales used in this study were analyzed, and in the main survey, the relationships between individual variables were verified. specifically, descriptive statistical analysis, path analysis, and mediating effect analysis were conducted in the main survey. the results of the study are as follows: first, health perceptions were found to have a positive effect on sports participation (p < . ). furthermore, health perceptions were found to have no direct effect on health promoting behavior (p = . ), while sports participation was found to have a positive effect on health promoting behavior (p < . ). additionally, sports participation completely mediated the relationship between health perceptions and health promoting behavior. based on the results of this study, suggestions are presented on how to enhance health perceptions in adolescents who are in a critical period for forming healthy life habits, and to prepare measures to encourage sports participation. as of , the world is facing the coronavirus disease (covid- ) pandemic. scientists predict that the covid- transmission may be at controllable levels over time, but that increasingly more novel viruses will be encountered. the outbreak of new viral infections is accelerating the development of treatment and vaccines at the national global level. people are responding to the new viral infections by strengthening environmental and personal hygiene and enhancing their individual immunity. in addition, people's interest in immunity-related health and related desires is increasing. however, as acquiring healthy life habits takes time, it is necessary to encourage adolescents to develop conscious health perceptions and healthy life habits. while emphasizing that the formation of healthy habits in adolescence is the foundation of lifelong health, it is also necessary to improve adolescents' health interests in various ways. this approach addresses the concept of health perceptions that are likely to be an important factor for determining future health behavior in adolescents. health perceptions refer to a subjective process in which individuals are conscious of external stimuli related to health through sensory organs [ ] . however, individuals do not perceive health in the same way, perceptions of health may differ based on how the person views and interprets facts [ ] . therefore, previous studies have claimed that the world perceived by each individual is different in similar situations, and the resulting behavior initiated by each individual is different [ , ] . such health perceptions in adolescents can be naturally linked to health promoting behaviors and habits. health promoting behavior involves an individual's perception of the importance of health for himself/herself and of engaging in preventive behaviors for promoting health. furthermore, it refers to improving health care skills by changing life habits through knowledge, attitudes, and behaviors about health [ ] . in addition, because health promoting behavior can reduce the cost of personal health care and is associated with an extended lifespan and improving quality of life, it can bring benefits not only at an individual but also a national level. the relationship between health perceptions and health promoting behavior has been reported in previous studies. the findings suggest that higher health perceptions in middle and high school students were associated with better health behavior [ ] . furthermore, an investigation into the relationship between perceived health status and other variables found that people with higher social support evaluated their health status more positively [ ] . in addition, the importance of health perceptions have been emphasized because they determine the attitudes and behavioral characteristics of an individual or a group, and have a direct or indirect effect on health [ ] . moreover, a study described that health promoting behavior and health perceptions could be enhanced through personalized health care customized to individual characteristics, and adapted to school life, thereby forming healthy life habits and enabling access to health care [ ] . furthermore, it focused on the possibility and role of sports participation in the "process" where health perceptions in adolescents affect health promoting behavior. sports participation is a social behavior initiated in connection with various sports phenomena and can be divided into behavioral, cognitive, affective, and social participation [ ] . physical activity habits formed through regular sports participation can be regarded as important variables that are highly likely to maintain and promote health, along with eating habits and life habits. previous research [ ] [ ] [ ] [ ] has reported a positive causal link between health perceptions and sports participation, this suggests that it can be predicted that adolescents' health perceptions could serve as an antecedent variable affecting sports participation. in addition, considering the results of previous studies [ ] [ ] [ ] regarding the relationship between sports participation and health promoting behavior, it can be assumed that sports participation may be related to health promoting behavior. the results of the aforementioned studies suggest that adolescents' health perceptions may affect health promoting behavior, and that sports participation may act as an explanatory variable in the relationship between health perceptions and health promoting behavior. however, since previous studies mainly involved adults, including older adults, it is difficult to generalize these results to adolescents. in addition, previous studies are limited in that they sporadically report only some of the variables in the relationships among health perceptions, sports participation, and health promoting behavior. in order to overcome these limitations, it is necessary to verify the effects of health perceptions and sports participation on improving health promoting behavior in adolescents, using an appropriate study design. reflecting on these points, this study aims to clarify the structural relationship between health perception, health promoting behavior, and sports participation, and to investigate the mediating effect of sports participation in the relationship between health perceptions and health promoting behavior. in order to clarify the aims of this study, the research hypotheses were established as follows: first, health perceptions will have a positive effect on sports participation (h ). second, health perceptions will have a positive effect on health promoting behavior (h ). third, sports participation will have a positive effect on health promoting behavior (h ). fourth, sport participation will have a mediating effect on the relationship between health perceptions and health promoting behavior (h ). specifically, sports participation will partly mediate the relationship between health perceptions and health promoting behavior (hypothesis model illustrated in figure ) or will fully mediate the relationship between health perception and health promoting behavior (competition model illustrated in figure ). int. j. environ. res. public health , , x of participation will have a mediating effect on the relationship between health perceptions and health promoting behavior (h ). specifically, sports participation will partly mediate the relationship between health perceptions and health promoting behavior (hypothesis model illustrated in figure ) or will fully mediate the relationship between health perception and health promoting behavior (competition model illustrated in figure ). the population of this study was adolescents living in the republic of korea in july . a total of korean adolescents were recruited to participate in this study using convenience sampling, a nonprobability sampling method, and were surveyed using google forms to collect the survey. the use of google forms could raise concerns about the accuracy of the answers. however, due to the practice of "social distancing" caused by covid- , online questionnaires were necessary. a total of survey responses were used in the study, surveys with incomplete information, which were judged to be inadequate for the purpose of data analysis, were excluded. this study was conducted after obtaining ethical approval from the institutional review board of wonkwang university (wkirb- -sb- ). the general characteristics of the participants are shown in table . participation will have a mediating effect on the relationship between health perceptions and health promoting behavior (h ). specifically, sports participation will partly mediate the relationship between health perceptions and health promoting behavior (hypothesis model illustrated in figure ) or will fully mediate the relationship between health perception and health promoting behavior (competition model illustrated in figure ). the population of this study was adolescents living in the republic of korea in july . a total of korean adolescents were recruited to participate in this study using convenience sampling, a nonprobability sampling method, and were surveyed using google forms to collect the survey. the use of google forms could raise concerns about the accuracy of the answers. however, due to the practice of "social distancing" caused by covid- , online questionnaires were necessary. a total of survey responses were used in the study, surveys with incomplete information, which were judged to be inadequate for the purpose of data analysis, were excluded. this study was conducted after obtaining ethical approval from the institutional review board of wonkwang university (wkirb- -sb- ). the general characteristics of the participants are shown in table . the population of this study was adolescents living in the republic of korea in july . a total of korean adolescents were recruited to participate in this study using convenience sampling, a nonprobability sampling method, and were surveyed using google forms to collect the survey. the use of google forms could raise concerns about the accuracy of the answers. however, due to the practice of "social distancing" caused by covid- , online questionnaires were necessary. a total of survey responses were used in the study, surveys with incomplete information, which were judged to be inadequate for the purpose of data analysis, were excluded. this study was conducted after obtaining ethical approval from the institutional review board of wonkwang university (wkirb- -sb- ). the general characteristics of the participants are shown in table . this study used scales that were deemed suitable for the purpose of this study selected from scales used in previous studies. the general characteristics of the participants were measured using two items regarding school level and gender on a nominal scale. health perceptions were measured using a scale that was based on the health perception scale developed by ware [ ] and was verified for its reliability and validity by kim and choi [ ] , kim, kim, and sok [ ] , and kwon [ ] . specifically, this scale consists of subscales, with a total of items, measuring the importance of health, health interest, confidence in health recovery, and health concern. health promoting behavior was measured using a korean version of the health-promoting lifestyle profile-ii (hplp-ii) originally developed by walker, sechrist, and pender [ ] , which was verified for its reliability and validity by kim [ ] , kim [ ] , and kang [ ] . specifically, this scale consists of subscales, with a total of items, measuring personal hygiene and life habits, nutrition and exercise management, eating habit management, stress management, and health responsibility. sports participation was measured using a tool based on a classification model for sports participation developed by snyder and spreitzer [ ] , which was verified for its reliability and validity by lee [ ] , lee and lee [ , ] . the scale consists of subscales with a total of items, measuring cognitive participation, behavioral participation, and affective participation. health perceptions, health promoting behavior, and sports participation were independently scored on a -point likert scale, ranging from "strongly agree" ( points) to "not at all" ( point). a preliminary survey was conducted to verify the reliability and validity of the instruments. the reliability was verified using cronbach's α, which tests the internal consistency of the items, and confirmatory factor analysis was performed to test validity. reliability is related to how consistently and accurately a method measures something and indicates the accuracy of the measurement [ ] . the reliability for each variable used in this study is shown in table . generally, cronbach's α cannot be judged to be unreliable until it reaches . or higher, but some scholars have argued that this scale's reliability can be ensured even if it reaches . or . or higher [ ] . the cronbach's α values of the observed variables used to measure health perceptions were between . and . , all of which were more than the reference value of . , indicating that the internal consistency reliability was appropriate [ ] . in addition, "alpha if item deleted" eliminated items (health interest # , confidence in health recovery # , health concern # ) higher than the total cronbach's α after deleting respective items were deleted. the cronbach's α values of the overserved variables used to measure health promoting behavior ranged from . to . , and the variable (personal hygiene and life habits) that did not show the desired internal consistency reliability was deleted. all other variables were evaluated as having an appropriate internal consistency reliability with a cronbach's α reference value of . or above. in addition, items with a cronbach's α value higher than the total cronbach's α (eating habit management # ) after deleting respective items were deleted. in addition, the cronbach's α values of the variables used to measure sports participation ranged from . to . , and the values for all variables were above the reference value of . , indicating that the internal consistency reliability was at an appropriate level. items with a cronbach's α higher than the total cronbach's α (cognitive participation # , behavioral participation # , and affective participation # ) after deleting respective items, were deleted. meanwhile, confirmatory factor analysis was used to test convergent validity, nomological validity, and discriminant validity of the scales. the goodness-of-fit indexes in confirmatory factor analysis were tested for incremental fit index through incremental fit index (ifi) and comparative fit index (cfi), and for absolute fit index through chi-square/degrees of freedom (x /df), root mean square error of approximation (rmsea), goodness of fit index (gfi), and root mean square residual (rmr). the results are shown in table . table . goodness-of-fit indexes in confirmatory factor analysis of proposed and revised models. however, some indexes were found to be below the reference value, and some items (health concern) were removed based on the squared multiple correlation (smc) value. consequently, the goodness-of-fit of the revised model was found to be good overall. the detailed goodness-of-fit indexes in the confirmatory factor analysis of the proposed and revised models are shown in table . in addition, the validity of the model was tested through confirmatory factor analysis and results are presented in table . the convergent validity was verified using three methods: standardized regression coefficient, average variance extracted, and construct reliability. the standardized regression coefficients for all variables ranged from . to . , and the significance (critical ratio) was . or higher. in addition, the construct reliability was found to be between . and . , and the average variance extracted was between . and . , indicating that the convergent validity was appropriate. the nomological validity was tested. this study predicted the relationship between constructs in a positive (+) direction, and the main relationship between latent variables showed a significant positive (+) relationship (table ), indicating that the nomological validity was secured. the discriminant validity was verified by comparing the correlations between the constructs, and the average variance extracted ( table ). the squared value of the correlation coefficient for "health perception ↔ health promoting behavior" was obtained, and the highest correlation was . , which was lower than the average variance extracted of health perception ( . ) and health promoting behavior ( . ), indicating that the discriminant validity between the variables was secured. the data were collected through two online surveys (a preliminary survey and a main survey) using google forms. the preliminary survey was conducted on korean adolescents in , and a total of survey responses, after excluding survey responses with incomplete information, were finally used for analysis. the main survey was conducted on korean adolescents in , and survey responses, excluding survey responses with incomplete information, were finally used for analysis the data collected were analyzed using spss and amos . program (ibm corp., armonk, ny, usa). the detailed analyses were as follows. first, frequency analysis was performed to examine the general characteristics of the participants (see section . ). second, the reliability of the tools used in this study was tested using cronbach's α (see section . ). third, confirmatory factor analysis was performed to test the validity of the tools, and then convergent, nomological, and discriminant validities of the tools were tested (see section . ). fourth, a descriptive statistical analysis was performed to examine the perception of each variable by the participants (see section . ). fifth, the goodness-of-fit of a hypothesis model was tested to verify the structural relationship between individual variables, and then a path analysis was performed (see section . ). sixth, bootstrapping was used to verify the mediating effect of sports participation on the relationship between health perceptions and health promoting behavior in adolescents (see section . ). it suggested that because it is difficult to ensure that the distribution of mediating effects is normal, , bootstrap samples generated by random sampling from raw data are to be used for parameter estimation, and a confidence interval is to be set at % [ ] . the bootstrap method was used in accordance with the suggestions. in addition, the indirect effects of health perceptions on health promoting behavior through sports participation were examined. to investigate the descriptive statistics of the variables (health perceptions, health promoting behavior, and sports participation) used in this study, all variables and sub-variables were analyzed, and the results are shown in table . the mean values were distributed between . and . , and the standard deviations were distributed between . and . . then, the skewness and kurtosis were examined. in general, it was assumed that a skewness value of < . and a kurtosis value of <± . are the bases of the violations of univariate normality assumptions [ , ] . the analysis results reveal that the absolute value of the skewness was distributed between . and . , and the absolute value of the kurtosis was distributed between . and . . these results could be evaluated as satisfying the conditions required for the normality for the structural equation model. the structural equation model developed in this study consisted of three latent variables: health perceptions, sports participation, and health promoting behavior, and observed variables: importance of health, health interest, confidence in health recovery, nutrition and exercise management, eating habit management, stress management, health responsibility, cognitive participation, behavioral participation, and affective participation. a path analysis of the study model was performed, and the goodness-of-fit of the entire study model was determined to analyze direct and indirect effects. the results show that the goodness-of-fit of the proposed model was overall acceptable, as shown in table . the results of verifying the hypotheses that analyzed the causal relationships between the individual variables using the study model showed that hypotheses one and three were supported, but hypothesis two was rejected. the results of testing the hypotheses are shown in table . s.e. = standard error, c.r. = critical ratio; *** p < . , tested by path analysis. first, the results of analyzing hypothesis one (health perceptions will have a positive effect on sports participation) show that the path coefficient was . (t = . ), supporting the hypothesis. second, the results of analyzing hypothesis two (health perception will have a positive effect on health promoting behavior) show that the path coefficient was . (t = . ), rejecting the hypothesis. third, the results of analyzing hypothesis three (health perception will have a positive effect on health promoting behavior) show that the path coefficient was . (t = . ), supporting the hypothesis. analyses were performed to verify the model that explains the structural relationship between the individual variables by verifying the mediating effect of sports participation on the relationship between health perceptions and health promoting behavior in adolescents. first, we comparatively analyzed the goodness-of-fit of a partial mediation model (the hypothesis model) in which health perceptions might directly affect health promoting behavior, while also affecting health promoting behavior through sports participation. the goodness-of-fit of a complete mediation model (the competition model), in which there might be no direct path between health perceptions and health promoting behavior, and health perceptions might affect health promoting behavior through sports participation, was also analyzed. we explored the model that explained the experience data best and was the simplest. the goodness-of-fit indexes of the hypothesis model and the competition model were calculated for comparison, as shown in table . table . goodness-of-fit indices of hypothesis and competition models. since the complete mediation model is an embedded model in the partial mediating model, a x difference test was performed. in the x difference test, which tests the difference in the degrees of freedom between the two models, a goodness-of-fit of . , which is statistically significant with α = . , was revealed. however, the results of the x difference test show that the x difference between the two models was . , and the difference in degrees of freedom between the two models was one, indicating that there was no statistically significant difference. a partial mediation model is selected if the results of the x difference test are statistically significant, and a complete mediation model is selected if they are not [ ] . therefore, both the complete mediation model and the competition model can be selected as the final model in this study. in other words, the direct effect of health perceptions on health promoting behavior were found to be not significant, whereas the indirect effect of health perceptions on health promoting behavior through sports participation was found to be significant. in addition, the bootstrap method was used to test the indirect effect of sports participation in the relationship between health perceptions and health promoting behavior [ ] . the bootstrap method was used to estimate the standard error of the indirect effect, which may be involved in the existing testing for mediating effects. with the bootstrap method, a confidence interval is provided, and if the confidence interval does not include , indirect effects are considered to be statistically significant. as shown in table , the indirect effect (β = . , % bias-corrected confidence interval = . - . ) of health perceptions on health promoting behavior through sports participation was statistically significant. in other words, it was found that higher health perceptions were associated with higher sports participation, thereby leading to higher health promoting behavior. this study aimed to clarify the mediating effect of sports participation on the relationship between health perceptions and health promoting behavior in adolescents, and to determine the importance of sports participation in forming healthy life habits during adolescence. the principal results of this study are as follows: ( ) first, health perceptions had a positive effect on sports participation. previous studies regarding the relationship between sports participation and health perceptions [ ] [ ] [ ] [ ] ] have reported that there was a positive causal relationship between the two variables, supporting the results of this study. in particular, a previous study reported that health perceptions improved with participation in exercise [ ] , and another study reported that sports activities had a positive effect on subjective health perceptions [ ] . as shown in the results of this study and previous studies, adolescents with high health perceptions can be interpreted as actively participating in physical activities, such as sports, in order to maintain and improve their health. accordingly, various measures should be provided to improve health perceptions in adolescence, which is a period that can lay the foundations for lifelong health education. in addition, efforts are needed to improve health perceptions, and to find and facilitate ways for adolescents to voluntarily participate in sports. second, health perceptions had no direct effect on health promoting behavior, but to have an indirect effect on health promoting behavior through sports participation. previous studies have reported a positive correlation between health perceptions and health-promoting behavior, which is supported by the results of this study [ , [ ] [ ] [ ] [ ] [ ] . in particular, previous studies have reported that there was a positive correlation between health behavior and health perceptions [ ] . furthermore, it is argued that help from schools, teachers, and communities is needed to improve the effectiveness of health perception programs for adolescents, and such programs should lead to effective programs in the future [ ] . given that as people get older their interest in health generally tends to increase, adolescents are more inclined to have a relatively low interest in health compared to people in other age groups. thus, enhancing health perceptions during adolescence can lead to lifelong health habits, and it is necessary to explore a variety of educational strategies to improve health perceptions among adolescents. third, sports participation had a positive effect on health promoting behavior. a study comparing the health promoting behavior and sports participation of college students in the republic of korea and japan [ ] found that the effect of lifestyle factors on health promoting lifestyles and sports activities in japan and korea is different. furthermore, they investigated health promoting behavior in university sports participants and found results that are consistent with the findings of the present study [ ] . in addition, a study reported that the experience of participation in program on physical fitness in hungarian older adults had a positive effect on health promoting behavior [ ] . from these results, it can be inferred that students' continuous participation in sports activities can effectively affect their health promoting behavior, they can live healthy daily lives, including their schoolwork and school life. therefore, when deciding on health promoting behavior projects and systems for adolescents, it is necessary for educational institutions, such as school authorities and the ministry of education, to consider the results of this study. fourth, sports participation had a complete mediating effect in the relationship between health perceptions and health promoting behavior. the present results show that adolescents with higher levels of health perceptions tend to participate more actively in sports activities, which may lead to increased health promoting behavior in adolescents. active participation in sports activities in adolescence, which is a critical period that can lead to lifelong health, can be seen as a prerequisite for living a healthy life. the results of this study are significant in that they reveal the importance of sports participation as a variable for forming a healthy lifestyle among adolescents. moreover, we believe these results are a theoretical basis for developing various policies and programs for adolescents' sports participation. recently, because of the pandemic phenomenon caused by covid- , the importance of personal hygiene management and a healthy lifestyle is being emphasized. this experience will make it extremely important for individuals to renew their perception of health. regular participation in sports to improve health from adolescence can be seen as a solid foundation for lifelong health [ , ] . the results of this study will help provide a theoretical foundation for the development and operation of educational institutions' programs to strengthen awareness of youth health and encourage participation in sports. the aim of this study was to verify the structural relationship between health perceptions, sports participation, and health promoting behavior in adolescents. the results of the study are as follows: first, health perceptions were found to have a positive effect on sports participation. furthermore, health perceptions were found to have no direct effect on health promoting behavior, while sports participation was found to have a positive effect on health promoting behavior. additionally, sports participation completely mediated the relationship between health perceptions and health promoting behavior. based on the findings and limitations of this study, suggestions for further studies are as follows. first, because the participants in this study were limited to korean adolescents, it is difficult to generalize the findings to the entire population. therefore, further studies are needed to involve adolescents in various countries to expand the sample size. second, since adolescents' health promoting behaviors can appear as a complex process involving various variables, it is necessary to conduct further studies using diversified variables that may affect health promoting behaviors based on the results of this study. third, since the scales used in this study were based on self-report, there is a possibility that the participants might respond with defensive attitudes, and their responses might be diminished or exaggerated. therefore, in order to overcome the limitations of the self-report questionnaire, it is necessary to examine various types of tests such as the use of a social desirability scale. fourth, in this study, the measurement of sports participation consisted of 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this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the authors declare no conflict of interest. key: cord- - g n e authors: steele, james harlan title: veterinary public health: past success, new opportunities date: - - journal: preventive veterinary medicine doi: . /j.prevetmed. . . sha: doc_id: cord_uid: g n e abstract animal diseases are known to be the origin of many human diseases, and there are many examples from ancient civilizations of plagues that arose from animals, domesticated and wild. records of attempts to control zoonoses are almost as old. the early focus on food-borne illness evolved into veterinary medicine's support of public health efforts. key historical events, disease outbreaks, and individuals responsible for their control are reviewed and serve as a foundation for understanding the current and future efforts in veterinary public health. animal medicine and veterinary public health have been intertwined since humans first began ministrations to their families and animals. in the united states, the veterinary medical profession has effectively eliminated those major problems of animal health that had serious public health ramifications. these lessons and experiences can serve as a model for other countries. our past must also be a reminder that the battle for human and animal health is ongoing. new agents emerge to threaten human and animal populations. with knowledge of the past, coupled with new technologies and techniques, we must be vigilant and carry on. farmer keeping animals in his midst. the people who domesticated the animals were thus the first to be victims. those early humans then developed resistance to some zoonotic diseases that had emerged (diamond, ) . the relation of animal diseases to human disease was observed in the ancient civilizations of babylon, the nile valley, and china and noted by leviticus in the old testament, and later by hippocrates in greece, and virgil and galen in rome. millions of people across europe during the middle ages suffered from plague carried by rat fleas. the invasion of europe by rinderpest in the th century disrupted commerce and government so much that the papal authority created a medical commission to advise the vatican on what measures should be taken to control the animal plague/rinderpest . the movement of animal diseases into the americas is believed to have been in the support of the settlements founded by columbus in santo domingo in . these livestock were the foundation animals for spanish colonies in the americas. in the next century, de soto, the spanish explorer of florida and the southeast, brought cattle, horses, and swine, as well as dogs that thrived. farther north, the virginia colonists brought animals to roanoke island, but none survived, neither humans nor animals. later the jamestown colonists imported domestic animals that survived and became valuable foundation stock, but no zoonotic diseases are recorded in any of these earliest settlements. not until was rabies the first zoonosis recorded in the us colonies, and later as an epizootic in both the colonies and the federation of states in the late th century (smithcors, a,b) . in , the newly founded medical repository editors were the first to inquire about emerging diseases in the united states and territories. they asked for information on human diseases, diseases among domestic animals, accounts of insects, the condition of the vegetation, and even the state of the atmosphere. they hoped to put the facts together as an annual report on the status of health in the united states. surgeon general luther terry ( ) of the us public health service (usphs) in his address at the american veterinary medical association (avma) centennial called this report the first reference to veterinary medicine in support of public health. a few years after this report, benjamin rush called for the establishment of veterinary medical education at the university of pennsylvania. the united states sanitary commission, organized during the civil war by public-spirited women, was concerned largely with sanitary conditions, including food hygiene. they were the first to call attention to the putrid meat and later embalmed beef sent to the army. the commission was to be a forerunner of public health in the years following the civil war (furman, ) . by the s, there was interest in developing a national health service. yellow fever epidemics were frightening as they spread up the mississippi river from new orleans. the possibility that yellow fever involved animals brought professor john gamgee, a famous veterinarian, from england to investigate the epidemic. he recognized the seasonal occurrencethat cold weather stopped the epidemic -and even suggested river traffic be limited to the colder months. however, he failed to associate the effect of cold weather with the decline of the numbers of mosquito populations, the vector of yellow fever (furman, ) . the us board of health came into being largely because of the yellow fever epidemic and the morbidity and mortality that it caused. by the time of the board's inception in , malaria was widespread in the south, and tuberculosis was a recognized disease. typhoid fever and enteric diseases were also common. in addition, animal diseases were present, especially the spread of glanders and anthrax following the civil war (furman, ) . in the president of the us board of health, dr. j.l. cabell, asked james law, professor of veterinary medicine at cornell university, to advise the board on how they should supervise the diseases and movements of domestic animals. law's report ( ) was the first comprehensive recognition of the effects of zoonotic diseases upon public health published in the united states (steele, ) . the organization of public health in the post civil war period has been reviewed by miles ( ) , former historian of the national institutes of health (nih). his report discusses the struggle between public health and agricultural interests in the decade leading up to the inauguration of the bureau of animal industry in . the interest of the bureau was to protect animal health, and later to provide a meat inspection service for public health, international trade, and subsequently interstate commerce. the relation of animal diseases to the public health and their prevention by frank s. billings ( ) was the first book to review the problems and the state of bacteriology as well as parasitology in the s. although the book is limited to trichinosis, hog-cholera, tuberculosis, anthrax, texas fever, rabies, and glanders, his knowledge of these diseases is remarkable for the time. billings gained this knowledge through education in berlin, where he learned about the history of animal diseases in the greco-roman period and the latin origin of ''veterinarians,'' which he says first appeared in the th century writings of vegetii. he also traveled extensively in europe, where he observed veterinary activities. billings makes a strong plea for the development of veterinary public health to control the animal diseases that affect man. he stated that this could be accomplished only by having trained veterinarians who were scientifically educated. he was one of the veterinarians who was active in the early years of the american public health association (apha), during which discussions of trichinosis, tuberculosis and other animal diseases took place at the early annual meetings. a true visionary of veterinary public health, billings pointed out that milk from diseased cows is dangerous. he appealed to the government to set up laboratories to use the new science of bacteriology to find the cause of illness of milk origin. food hygiene came into being only with the new science of bacteriology (billings, ) . the frightful toll of milk borne disease is reviewed by stenn ( ) . in his report, he cites the shocking figure of deaths per births in new york city in . spoiled milk accounted for the deaths of thousands of children in the early s, and in many other cities. the records of , cited by stenn, list many milk borne outbreaks of typhoid fever and diphtheria. he goes on to state that % of the milk cans sampled contained tubercle bacilli, and in cities, % of the milk had tubercle bacilli. in a milk borne typhoid epidemic occurred in washington, dc, that caused president theodore roosevelt to order the usphs to investigate the local supply. surgeon general walter wyman ordered his staff to examine not only the washington milk problem but to examine the national milk problem. the report milk and its relation to public health by milton rosenau, issued by the usphs, brought reform to the dairy industry and support for the bureau of animal industry program to control bovine tuberculosis (myers and steele, ) . pasteur took milk safety even further, changing science and veterinary medicine by creating a new concept of the origin of disease. no longer would the myth of spontaneous origin of disease guide society, although there were as many objections to scientific advances then as now. the centennial celebration of the rabies vaccine revealed in pasteur a man of many accomplishments. he was a chemist who discovered the cause of fermentation and applied it to the beer and wine industries, a process that led to milk pasteurization. he was an artist who was known to the impressionists of the th century as the man who prepared better paint colors. he was also a genius who gave public health the science and vaccines to combat th century diseases and prepare for the th century's emerging problems (koprowski and plotkin, ) . although the concept of pasteurization of beer and wine brought fame to pasteur, the application to milk was less known, and it was accepted no more readily than the concept of evolution. it was asserted that all kinds of illness and changes in well being would ensue from pasteurization. the eradication of bovine tuberculosis and brucellosis (bang's disease) insured a safe milk supply and protected the health of farmers, dairymen, veterinarians and the handlers of milk and milk products. the case for pasteurized milk and milk products is conclusive. in the late th century, a new array of milk borne zoonoses is of concern to public health and veterinarians. some date back to the th century, such as salmonella. the salmonella were identified in by one of the most distinguished public servants of the veterinary profession, dr. daniel salmon. as the first chief of the bureau of animal industry (bai) from to , he assembled and trained a great staff. this included theobald smith, v.a. moore and e.c. schroeder, who solved the epidemiology of texas fever caused by babesia bigemina, which is carried by the tick boophilus annulatus. salmon was the leading proponent of veterinary public health in the s. he asked for, and received from congress, authority for a federal meat inspection service in to meet the demands of foreign commerce. however, his national program was circumvented by local interests citing states' rights; therefore, the meat inspection act of was ineffective nationally. salmon sought support from the apha and the american medical association for these early veterinary efforts to protect public health. unfortunately, these agencies did not support him (schwabe, a) . the federal meat inspection service act of came about only after sinclair ( ) exposed the filthy conditions of the chicago stockyards. salmon was blamed for the local hygiene failure over which he had no authority and was removed from office. however, he is remembered today by the usda's salmon award for leadership. in , the bai initiated tuberculin testing of dairy cattle in the district of columbia, a demonstration that revealed an infection rate of almost %. this was the beginning of a successful tuberculosis control campaign that led to its eradication under john r. mohler, bai director from to . the late jay arthur myers memorialized the near eradication of bovine tuberculosis in his book, entitled ''man's greatest victory over tuberculosis'' (myers, ) . at the start of the th century, pathologists were greatly interested in comparative medicine. they were led by karl f. meyer, a swiss veterinarian who was to become one of the leaders and outstanding scientists of the th century. he was among the early public health scientists to delve into virology as professor of pathology at the university of pennsylvania (penn), and in he may have been among the first to recover a virus causing equine encephalitis. as director of the pennsylvania livestock sanitary board laboratory, he published on glanders, anthrax, anaplasmosis, sporotrichosis, paratuberculosis, septicemia, and many other diseases of animals. in he left the university of pennsylvania to accept a position at the university of california's newly established tropical medical center. the following year, he accepted an appointment to the george williams hooper foundation for medical research at the university of california medical center. he remained there the rest of his life and become a legend. his lectures introduced medical students to the biologically active world, including the zoonoses, plant life, the atmosphere and all that is called the environment today. at the hooper foundation, meyer researched a wide spectrum of animal diseases of public health importance. after being active in the investigation of human influenza in - , he went to the field to define the epidemiology of malaria, dysentery, and even dental diseases. his study of the bacterial causes of abortion in animals resulted in bringing together brucella abortus, brucella melitensis, and brucella suis in a new genus honoring david bruce. another important event was his report on clostridium botulinum in nature. botulism became a national concern in the s when california canned fruit and vegetables were found to contain botulinum toxin. the industry asked meyer to resolve the problems and underwrote a laboratory to maintain surveillance. thereafter, meyer was active in food safety, but he was also concerned with humane animal care in which he maintained an interest all his life. in , meyer and his long time lab associate bernice eddie began their series of psittacosis reports in birds. these reports eventually led to control years later with tetracycline-impregnated seed. the same antibiotic is now used to prevent ornithosis in domestic fowl (meyer, ) . one of meyer's most memorable lectures was in when he called attention to the importance of the animal kingdom as a reservoir of diseases that endanger the health and welfare of people throughout the world (meyer, ) . in , he first reviewed the state of the animal reservoir of diseases, by then referred to as zoonotic diseases, before the world health organization (who) general assembly. he repeated the same theme before the who expert committees for the zoonoses, plague, food hygiene and for the pan american health organization (paho) until his th year. meyer's work on plague was reported in the special supplement of the journal of infectious diseases to commemorate his th birthday. this was underwritten by max stern, president of hartz mountain, which supported the psittacosis control investigations at the hooper foundation (steele, ) . meyer died in san francisco on may , , less than a month before his th birthday. larry altman ( ) , the medical editor of the new york times, wrote a lengthy obituary from which the following excerpt is taken. it also appears on the fore page of the journal of infectious diseases (supplement), may : ''dr. karl fredrich meyer was regarded as the most versatile microbe hunter since louis pasteur and a giant in public health [. . .] . public health leaders yesterday called his contributions to medicine 'monumental.' his scientific work had such broad implications that it touched on virtually all fields of medicine.'' the obituary was placed in the congressional record that same month. in , albert sabin ( ) wrote a biographical memoir of meyer for the national academy of science, of which meyer was a member from l to . sabin explains that as a youth in basel, switzerland, pictures of the black death so fascinated meyer that he became an outdoor scientist instead of following in the aristocratic business world in which he grew up. he told friends that in choosing to become a veterinarian he could ''be a universal man and study all diseases in all species.'' the s were memorable for public health growth and scientific advances. the viral etiology of influenza was uncovered by richard shope and thomas francis at the rockefeller institute. the use of egg embryos was a new method of growing viruses that would lead to the chick-embryo rabies vaccine and other viral vaccines. the development of the strain brucella vaccine and the stern anthrax vaccine in south africa were important to the control of brucellosis and anthrax worldwide. earlier investigation of toxoids by gaston ramon, a french military veterinarian, led to the discovery of tetanus toxoid for both horses and humans. discovery of the sulfa drugs and penicillin gave the clinician medication he had not dreamt of, a prelude to great advances in medicine. to be a veterinary student in the late s was both exciting and slightly dangerous. the brucellosis epidemic among veterinarians -both students and clinicians -raised epidemiological questions as to how brucellosis was spread. in michigan state college experienced an epidemic among veterinary students and others in the bacteriology building (holland, ) . up to then the disease was thought to be caused by direct exposure or ingestion of milk borne brucella, and airborne brucella was not given much consideration. the episode at michigan state college would change that oversight. as a student in the brucellosis testing laboratory, i heard discussion of the means of spread being water borne and back siphonage. professor i.f. huddleson, whose research laboratory was the focus of this investigation, disagreed with the state investigators, who were public health scientists and engineers focusing on the water borne theory. these investigators suggested contaminated glassware was not being autoclaved properly, and in turn, viable brucella was getting into the water system (newitt et al., ) . the discussion of the epidemic, which affected most of the people in the building, along with other public health interests of dean ward giltner, professor h.j. stafseth, professor i.f. huddleson and dr. w.t.s. thorp of the michigan state university college of veterinary medicine, led me to think about a career in public health. dr. stafseth encouraged many students to consider public health as a career (stalheim and steele, ) . when he learned of my interest, he and dean giltner worked out a program to make me eligible for a usphs fellowship. i was excused from senior clinics to pursue the fellowship. my assignment was an internship at the michigan health department. there i observed and learned from health department veterinarians, pathologists and bacteriologists how to remove and examine an animal brain for rabies and to inoculate mice to further confirm the diagnosis. vaccinia were grown on the belly of a calf that had been shaved, scrubbed and disinfected. after harvesting the scabs, the vaccinia would be tested for contaminants. it was a lengthy procedure. the same high standards were maintained for the pertussis/whooping cough vaccine, equine antiserum for tetanus and rabbit pneumococcal antiserum. it was a learning period that would serve me well. dean giltner and c.c. young, the director of the michigan public health laboratories, put together my fellowship application to the usphs and harvard school of public health. approval came the week before graduation, and my bride-to-be aina oberg and i were elated. we were married the evening after graduation, with many of the faculty and classmates in attendance two days later i took the michigan examination to practice veterinary medicine. the summer of was spent as an intern at the petoskey animal hospital. there i learned about swimmer's itch-a common affliction of man and pets caused by an avian schistosome. i was exposed to the parasite while swimming in inland lakes. at harvard it became my thesis subject. later it was the first subject i reported on at the avma convention in chicago ( ) with dean giltner in the audience. at harvard, there was talk of war. president conant addressed the incoming class with the admonition there would be important world changes during their student years. the school of public health's dean cecil drinker, the faculty, and the students were stimulating. i was the only veterinarian, which attracted some attention, and the medical school librarian was delighted to know there was a veterinarian around. she showed me a remote section of the library that contained many old books on veterinary medicine-harvard had a veterinary faculty from to . we students were delighted with our newly found classmates, and many of us would remain lifetime friends. to me, the academic work was not demanding except for statistics, which took much time. after all, in those days, we used hand-cranked machines for tabulations. my wife, aina, first worked at the harvard co-op and then with the british american ambulance volunteers. she enjoyed the students and compliments and being invited to fundraisers for the volunteers. then tragedy struck. a sudden collapse with fever hospitalized her. the diagnosis was advanced tracheal-bronchial tuberculosis that would confine her to sanitariums and hospitals for the next years, from january to april . after innumerable surgeries, the newly discovered streptomycin saved her life after months of treatment. eventually, we established a home and family with two sons, jay and david, in atlanta, georgia, for years. there aina died from the complications of arrested pulmonary tuberculosis in . the new year ( ) brought unforeseen problems, mainly medical bills, even though student health expenses were covered to a lesser extent. i sought work at the angel memorial animal hospital, where i knew some of the staff. when dean drinker heard of my after-school work plans, he called me into his office and told me to concern myself with school and taking care of my wife. a check signed by dean drinker awaited me in his secretary's office, a practice that continued until graduation. the drinker society still honors his contributions at the harvard school of public health, which we support. as graduation neared, many of us knew we were going into uniformed service job opportunities. i was deferred by the lansing michigan draft board, but i volunteered for the army veterinary corps and the navy special services, an epidemiology unit. both declined my services, and in the meantime, i found no positions of interest. i wanted to do epidemiology of the animal diseases affecting human health, but all the positions i was interested in required a medical degree. finally i brought my dilemma to dean drinker's attention. shortly thereafter, he asked me to his office to talk over my future. i was upset that it seemed i must have a medical degree to be an epidemiologist. should i get an md? dr. drinker and his wife, also a physician, heard me out. their reply was to list my attributes: good student, industrious, good appearance, good speaker, and creative ambitions. that said, they followed with memorable advice: ''jim, fly under one flag.'' before leaving harvard, i met kf meyer who was lecturing at the school of public health. some days later, i learned he had asked about me because he anticipated some research contracts with the us army epidemiology board and would need staff. i was elated when he offered me a position, and aina and i left boston with high expectations. some days later we arrived in chicago, only to find out a week later that meyer had not received the contract and had no funds to support the research position. i was depressed: no job and a sick wife. a few days later i visited the usphs chicago regional offices to seek their help in finding work. i appeared unannounced and asked a secretary to see the director. while waiting, a medical officer appeared and asked if he could help. i explained that i was a usphs fellow they had supported in getting an mph, and my objective was to find a position where i could investigate the epidemiology of animal diseases that affect the public health. dr. henry holle, the medical officer, listened and replied he never heard about such a situation. so he took me to see the medical director, mark ziegler, a tall, soft-spoken, southern gentleman. the availability of a young mph graduate led them to call washington. a week later after a review of my qualifications and evidence of my education, i was offered an internship as a civilian sanitarian in the ohio department of health. there i would spend the next year, july -october . the challenges were milk sanitation problems, food borne diseases, diarrhea, typhoid, rabies and the ohio river flood, a great learning experience. in september , the us army offered me a commission as a veterinary officer which i planned to tentatively accept. within days, medical director frank meriwether told me since the usphs had given me a fellowship, they should have a first call to commission me. i received a commission as a sanitarian on november , . afterward, i spent a short tour of duty in the midwest region with senior sanitarian william h. haskell, an authority on pasteurization methods and practice. he was one of the civil service veterinarians brought in by the usph milk specialists early in . in , other newly recruited veterinarians raymond helvig, ray fagan, and ted price were also commissioned as sanitarians. they were the only veterinarians in the usphs except for a veterinarian who was an animal control officer in world war i in and two parasitologists willard wright and maurice hall at the nih in the s. from chicago, i was ordered to report to washington, dc, for orientation. there i learned of my assignment to puerto rico and the virgin islands where i was to be responsible for coordinating milk and food sanitation and evaluating any zoonotic diseases in areas that had been isolated by the war. brucellosis and bovine tuberculosis were widespread. the diagnosis of venezuelan equine encephalitis and bat rabies in trinidad caused some concern in the islands but did not spread beyond trinidad. rabies was indigenous in the dominican republic and cuba in the s. in march , the pan american sanitary bureau asked the usphs san juan, puerto rico, office to do an assessment of the post-war veterinary public health problems in the dominican republic and haiti, neither of which had a functional veterinary service. i was directed to make a report on their problems. in the dominican republic, there were no reported diseases, but bovine tuberculosis, brucellosis and mastitis were known. no veterinary laboratory support existed, and the abattoirs kept no records. rabies had been reported in dogs, and possibly in horses, and some years later there was an epizootic of equine encephalitis. president trujillo kept some racing horses near ciudad trujillo (santo domingo), and i was asked to examine them. these old horses were brought to the dominican republic before the war in - . all were broken down and hardly fit to run. regardless, the dominican republic officials thought i could repair their ailments. when i told them i could not, they complained that i was not cooperative to the u.s. embassy, who then told me to be cooperative. later i visited the trainer, who told me, ''we will do what we can.'' thereafter, i was anxious to leave and went to haiti within a few days. port-au-prince was a rundown but hospitable capital. the country had been ravaged by tropical fevers for decades; malaria and filariasis were widespread. animal diseases were mainly fever and parasites, but an epizootic of anthrax in the early s was still present in : the disease was sporadic in the countryside. to my amazement, the dead animals were salvaged regardless of what they died from. there were no veterinarians in the government or in practice. still, the abattoir in port-au-prince was an elegant open iron structure. the cattle were immobilized by pithing, in which a small blade severs the spinal cord after which they are bled and eviscerated. the procedure was done rapidly, usually late at night, and the meat was distributed early the next day. however, a serious shortage of animal products existed, and few shops had any meat for sale. all in all, my stay at port-au-prince and the rural areas was a distressing experience. some weeks later i was in washington for further assignment as the war wound down. while there, i visited the pan american sanitary bureau to discuss my report with surgeon general hugh s. cumming who served the pan american sanitary bureau for a decade, after retiring from the usphs. at our meeting, i emphasized the need for a veterinary public health program to help in updating the animal health, preventing zoonotic diseases, and enhancing food safety. dr. cumming suggested i discuss the need for a veterinary public health program with his medical staff, where the proposal was enthusiastically accepted. the veterinary public health program was initiated with dr. aurelio malaga alba, a peruvian military veterinarian, as a consultant. dr. fred soper, the post-war director of the reorganized paho appointed dr. ben blood to organize a veterinary public health program in june . he carried on until and was followed by the outstanding public health veterinarian dr. pedro acha. the temporary duty in dc left my future uncertain. i was to be assigned to kansas city to prepare for the problems that might evolve with the invasion of japan. i took leave to spend some weeks with my hospitalized wife whose health was failing. the end of the war in europe and the pacific shortly thereafter changed my reassignment. i returned to dc to meet with assistant surgeon general joe mountin, whom i met earlier in puerto rico. dr. joe dean, his deputy, had arranged the interview. after a few inquiries about my wife's health, dr. mountin came to the point: ''what are you veterinarians going to do for the public health now that the war is over?'' the follow-up to that interview is in the appendix of ''the th anniversary of the veterinary medical corps officers of the u.s. public health service.'' after the approval of a veterinary public health section in the states relation division in december , i spent some months at the national institutes of health. i also worked to establish liaisons with the usda, bai, federal agencies, congressional interests, state relations, the avma and apha. in september after surgeon general parran's approval of the veterinary medical officer cadre, dr. mountin felt my washington activities were successful. he told me i was to be assigned to the newly created communicable diseases center, formerly the malaria control in war areas. there the veterinary public health program was established as a division, but it was a challenge to integrate. the new director of the centers for disease control (cdc) was dr. r.a. vonderlehr, previously chief of the puerto rico regional office, who i served under. he gave excellent support as did his deputy, dr. justin andrews, who succeeded dr. vonderlehr a year later. rabies was a national problem after the war. there was a great movement of people as war industries and encampments closed, and as a result, pets were lost or abandoned. the incidence of human rabies was the highest ever recorded, and unfortunately, human vaccine therapy was not always effective. canine rabies vaccine protection was short, with the vaccines being given every months. therefore, rabies became the lead program of the veterinary public health division. to head the activity, dr. ernest tierkel, a university of pennsylvania graduate who had completed his mph at columbia school of public health in , was recruited. he, dr. robert kissling and martha eidson along with a staff of animal handlers became the nucleus of the national rabies program at the rockefeller rabies investigation center in montgomery alabama (steele and tierkel, ) . the center was transferred to the cdc for $ . . they successfully demonstrated the effectiveness of a new chicken embryo rabies vaccine in the laboratory (tierkel et al., ) and in epidemic situations in memphis, tennessee (tierkel et al., ) . dr. mountin had learned from the public health authorities of indiana, michigan and others that brucellosis in man was of concern. they went so far as to say that as the sanitariums lost tuberculosis patients, brucellosis patients would take their place. the indiana health department was to be a brucellosis project site under dr. sam damen, the director of laboratories. the goal was to determine what action the health agencies should take. the federal bovine brucellosis control program was active in all states, so it became apparent that if the health authorities gave their support, the federal state brucella control program could eliminate the animal source of the human disease. late we brought the problem to the attention of dr. herman bunderson, chicago's dynamic health officer who remembered the struggle to eradicate bovine tuberculosis in the chicago milk shed, which included dairy herds in six midwestern states. in , he had required all milk coming into chicago to be from tb-free herds regardless of whether the milk was to be pasteurized. he recognized the brucella problem and shortly thereafter instituted the same standards for the elimination of bovine brucellosis in the s. the brucella eradication program was supported by the usphs milk code, which required that all grade a milk be from disease-free herds (us public health service, ) . the chicago brucella control program was soon adopted by big city health authorities, which gave impetus to the joint state federal brucella programs. as a result of these efforts, human brucellosis declined rapidly in the midwest from a high of thousands of human infections to hundreds in less than a decade. thereafter most of the human cases were of occupational origin, in travelers or in people using raw milk in rural areas. in the s there was a scare of brucellosis at dugway proving grounds, a military research center in western utah. dr. herbert stoenner investigated the alleged contaminated area and found the problem to be a rodent disease caused by brucella neotoma. this organism does not cause disease in man or domestic animals, but will cause antibody formation in cattle (stoenner and lackman, ) . after world war ii, there was great interest in the application of atomic energy for civilian use. professor s.f. gould ( ) at wayne state medical school initiated studies on the use of irradiation to destroy trichinella. he persuaded the american medical association to host a trichinosis symposium in in which the cdc participated. the evidence was conclusive that gamma radiation was effective at low doses (gould et al., ) . this was the beginning of my interest in promoting food irradiation, but it was not until that irradiation for commercial use was approved by federal agencies. the zimmerman human tissue survey - revealed the lowest rate of trichinosis ever (zimmerman et al., ) . modern pig raising, the prohibition of garbage feeding of swine, and consumer education are all contributing factors in the decline of the disease in pigs and humans (steele, ) . trichinosis has continued to decline in the states except in wild animals especially bears. other veterinary public health studies of parasitic diseases involved creeping eruption, also known as cutaneous larva migrans. this condition is due to the common dog hookworm larva ancylostoma caninum entering the skin and causing intense itching. this disease was common in the southeast states among persons exposed to damp, sandy soil; children playing in sandboxes; bathers at the beach, and utility men (cypess, b) . toxocariasis or visceral larva migrans is another parasite due to the dog, and sometimes the cat, roundworm larva migrating in the body of a foreign host, human beings (cypess, a) . dr. peter schantz confirmed these findings as a world health problem. toxoplasmosis was recognized as a human infection, and the domestic cat is recognized as a common source of human infection. infection is more likely to be caused by consumption of raw or undercooked meat. irradiation is effective in destroying this oocyst in meat (gould et al., ) . in the early s, a large equine encephalitis epizootic in central california required the assignment of all cdc veterinary officers. later another equine encephalitis epizootic occurred in new jersey in . since then there have been only occasional epizootics of the equine encephalitides. although the principal reservoir is birds, there is also survival of the virus in mosquito eggs that over winter. the cdc-fort collins laboratory has been at the forefront of these investigations. the most recent mosquito born disease is the introduction of west nile virus into north america in . wild birds and common city birds are the reservoirs, and the culex mosquito is involved in the transmission. horses may show clinical signs. control of the vector mosquito breaks the transmission cycle. plague, primarily a disease of rodents, is sporadic in the united states. the appearance of plague in domestic and feral cats and squirrels has brought the ancient scourge to households in the western states (poland and barnes, ) . however, dogs were never identified as carriers of the disease to man. an unusual epidemic of anthrax caused alarm in animal and human public health circles in the s. the anthrax was introduced by contaminated bone meal used in animal feed to improve lactation in sows. a radio announcer in cincinnati raised the question if cows' milk could be a vehicle for anthrax to be carried to humans. a search of literature found that milk was never a vehicle or cause of human or animal anthrax disease because the high fever of the disease stops lactation (steele and helvig, ) . salmonellosis was a recognized public health problem early in the s as well as during world war ii and afterwards among the civilian populations (galton et al., ) . after the war, investigators demonstrated it was widely disseminated. dr. phil edwards led the way at the university of kentucky and later at the cdc. mildred galton, chief of the veterinary public health laboratory contributed with her unusual ability to find evidence that others had overlooked. she demonstrated salmonella in many animals. her studies of transported pigs revealed how stress caused latently infected pigs to become shedders. the same reaction was found in other species. her work on raw eggs and meats led to the pasteurization of egg slurry used in baked or cooked products. she was among the first to find salmonella in raw milk years ago, and her work on the frequent presence of salmonella in poultry led to the federal poultry inspection program in the late s (steele and galton, ) . thirty years before weil described leptospirosis in humans in , animal leptospirosis was identified as its own problem. a record of an canine epidemic in stuttgart, germany, exists, but the etiologic agents were not determined. years after the canine epidemic, it was discovered that microorganisms morphologically identical caused the disease in both dogs and humans. leptospirosis proved confusing to all health professionals partly because ''isolated serovars were given names denoting the clinical signs observed in the patients from whom they were isolated'' (torten, ) . therefore, it was thought that serovar grippotyphosa would cause signs similar to catarrhal fever, and serovar icterohemorrhagia would cause hemorrhagic jaundice. it was not recognized that both serotypes are capable of causing both signs (torten, ) . in the us, there were numerous outbreaks among animal handlers, veterinarians and swimmers as well as people whose occupation exposed them to contaminated waste water in the - period. leptospirosis is now recognized as a problem associated with disasters such as flooding and earthquakes. there is wide agreement that vaccination of cattle and dogs has reduced environmental contamination (stoenner et al., ) . galton ( ) edited the ''leptospiral serotype distribution list '' through , and sulzer ( ) carried it up to . they were truly dedicated in keeping these records. listeriosis was first recorded in in sheep, and the first reported human case was in denmark in (bomer et al., ) . prevention of listeriosis is still not possible with the knowledge available, as there are no immunizing agents of proven worth. killed bacterins have been disappointing, and living attenuated vaccines have not been evaluated properly nor have they shown promise in limited experiments. good physical hygiene is essential to prevention (bomer et al., ) . groups at high risk of infection are pregnant women, neonates, diabetics, alcohol dependents, persons with neoplastic disease, or those being treated with corticosteroids or antimetabolites. among animals, ewes are at the highest risk late in the first pregnancy. sheep in late pregnancy should not be fed ensilage of doubtful quality nor be exposed to severe cold or inclement weather and crowding (bomer et al., ) . improved measures for preventing and controlling human listeriosis depend on increasing awareness of its diverse clinical manifestations and an increasing index of suspicion. because l. monocytogenes, the causative agent of listeriosis, is sensitive to most antibiotics, their early administration, once the diagnosis has been established, significantly decreases mortality. cortisone and its derivatives may, however, cause asymptomatic listeria infections to become overt (bomer et al., ) . after the end of the war in europe, the breakdown of food hygiene there allowed salvaged food to spread zoonotic diseases. at the same time there were numerous cases of listeriosis reported in france that caused abortion, stillbirths and reproductive tract disease (seeliger, ) . the disease remains prevalent in western europe to the extent that all midwives and obstetricians alert their patients to report symptoms. since there has been a steady decline of reported cases. food borne listeriosis elsewhere was virtually forgotten until when an outbreak occurred in the maritime provinces of canada and was associated with consumption of contaminated coleslaw (schleck et al., ) . then years later, a major outbreak in massachusetts between june and august of was epidemiologically linked to consumption of a particular brand of pasteurized whole and % milk (fleming et al., ) . although questions have been raised about the adequacy of the epidemiologic study (ryser and marth, ) , no other food has emerged as the vehicle that transmitted l. monocytogenes in this outbreak. in mexican-style cheese made in a factory near los angeles was definitively linked to a large outbreak listeriosis (linnan et al., ) . this was followed in by the linking of consumption of vacherin mont d'or, a variety of cheese, to an outbreak of listeriosis in the canton of vaud in switzerland (bille et al., ) . in recent years, food borne outbreaks continue to be reported in north america and europe. during the s, many more human cases and deaths were reported in the united states. the vehicles reported as contaminated were cold cuts, canned meats and frankfurter sausages. worldwide, listeriosis is a problem mostly in the temperate zones. another emerging zoonotic food borne disease is escherichia coli o :h , the enterohemorrhagic strains as well as those characterized by cytotoxins. these e. coli and others of human origin are major causes of the human enteric disease. however, they are less causative in food producing animals that may be infected but show few or no clinical signs. pasteurization of milk is effective in the control of e. coli spread. irradiation has proven effective for pasteurization of food of animal origin for the protection of the public health. recently improved inspection and hygiene have reduced reported human diseases, even though toxic e. coli is wide spread among cattle. the same can be said for newly identified emerging food borne zoonotic diseases. cryptosporidia parvum is a coccidian protozoa found worldwide. giardia are found in numerous animals, and during the late th century, the flagellate protozoan was identified worldwide as a water borne disease of humans and animals. old problems new to the states are taenia saginata and t. solium, largely found in immigrant workers. the tapeworm cysts found in meat, beef and pork are easily destroyed by irradiation, a technology that slowly is being accepted in the southern countries where tapeworm disease is recognized as both an economic as well as a public health problem. the acceptance of veterinary public health internationally by the paho has been previously discussed. the inauguration of veterinary public health as a national program in the usphs in stimulated interest worldwide, especially in the newly created international agencies. the united nations health office organizing committee chaired by surgeon general tom parran met in new york in june to further public health worldwide. the public health service officers and personnel were asked by the surgeon general's chief of staff, g.l. dunnahoo, to suggest topics. veterinary public health was new, but a few weeks before the organizing group was to meet, i was directed to make a veterinary public health presentation and answer questions at the surgeon general's staff meeting. after the meeting, i asked dr. dunnahoo if he would be interested in a recommendation for a veterinary public health program for the who organizing committee. he urged me to give him a memo recommending a veterinary public health activity. that may , , i wrote a memo paraphrased as follows: ''regarding our conversation and your encouragement, i propose that in the organization of the united nation's health office there be a veterinary public health (vph) program. the vph program would be concerned with animal diseases transmissible to man. the vph would carry on liaisons with veterinary activities in the agriculture agencies and collect information on animal health.'' some months later i asked how the vph recommendation was received. dr. dunnahoo said there were no objections or discussion: the vph item was accepted and placed in the records. years later i learned an american veterinarian, martin m. kaplan, was recruited by an english physician with whom kaplan worked with in the united nations relief and rehabilitation administration (unrra) in greece. in kaplan came to the newly established who in geneva, switzerland. he developed a vph program in the communicable disease division that is a model for a public health program in the developing world. during the next years, he organized the expert committee meetings and technical reports. the first was in l (who, ) to review tuberculosis, which was a major disease problem in humans and animals at the end of world war ii. an american tuberculosis authority, dr. franklin top, a us army consultant, had reported that % of the human cases in occupied germany were caused by mycobacteria tuberculosis bovis. the problem was referred to the who expert zoonoses committee by the who expert tuberculosis committee. there was no consensus on what recommendation to make. the danish veterinarian dr. plum spoke for the classical tuberculin test and identification. the french urged the use of bacille calmette-guérin (bcg) vaccinations. the success of bovine tuberculosis eradication in the united states was recommended as the ideal method. eventually the committee recommended test and removal, with the caveat for developing countries to try other methods, including the bcg vaccination, which had no success in field trials. a number of other diseases were reviewed with the recommendation for control. there was a consensus on the following: q fever, anthrax, psittacosis, and hydatidosis. another issue was to settle on a definition of veterinary public health. a current definition of public health is summarized as diseases that are naturally transmitted between animals and man. the following year, , who called together a panel of rabies experts, including e.s. tierkel of the cdc (who, ). tierkel and others who followed from the cdc, namely george baer, keith sikes, jerry winkler and currently charles rupprecht, contributed to rabies control and prevention. the first of the who expert committees on the zoonoses was followed by zoonoses study groups in , which meyer chaired in stockholm (who, ) . he was most effective in leading the committee, and in his closing remarks he passed the leadership to james steele. at the next meeting of the who zoonoses expert committee in geneva in , i was the chairman (who, ) . the next meeting in was chaired by calvin schwabe (who, ) , professor of epidemiology at the university of california school of veterinary medicine and the school of human medicine. schwabe ( b) summarizes the who veterinary public health in his monumental third edition of veterinary medicine and human health: ''the final objective of veterinary medicine does not lie in the animal species that the veterinarian commonly treats. it lies very definitely in man, and above all in humanity.' ' we in veterinary public health recognize the contributions of acha and szyfres ( ) for their invaluable book, zoonoses and communicable diseases common to man and animals in spanish and english. it has been the foundation of veterinary public health epidemiology and surveillance in the spanish speaking countries of the americas. at this time, dr. george beran is to be recognized as one of the consultants to paho and who, and for his work in the philippines. he has carried on in admirable style for more than years in teaching, research, health promotion and consulting, and as author and editor. he has updated the chemical rubber company (crc) handbook of zoonoses series (beran, ) and the paho zoonoses reports, and hopefully will continue to do so. he is a historian of veterinary public health. in closing we pay tribute to the american veterinarians who demonstrated and promoted veterinary public health in the united states. most of these early pioneers years ago were recruited by the cdc and assigned to states that had zoonotic disease problems, mainly rabies. among the early cdc recruits assigned to a state was ernest wine. he was sent to pennsylvania, where he remained for years, rising to the position of state epidemiologist. oscar sussman went to arizona, and later the new jersey health department recruited him, where he built an outstanding program. martin baum served colorado for many years after leaving the cdc. john mason served in new mexico. art wolff did excellent service in michigan before returning to washington, where he became a leader at the usphs in environmental health as a radiation authority and assistant surgeon general. herbert stoenner went to utah and raymond fagan to indiana as described earlier. monroe holmes followed stoenner to utah, and john scrugs went to indiana when fagan went to the harvard school of public health. john winn, francis abimanti, don mason, and lauri luoto were among the early investigators of q fever in california. stoenner, in addition to his investigation of brucellosis and leptospirosis, was also a leader in q fever studies. don mason, john richardson, and paul arnstein worked on the control of psittacosis in k.f. meyer's laboratory at ucsf. dick parke, joe held and robert huffaker kept the cdc office responsive to many inquires and provided service to the states. james glosser closed his career at the cdc in . his work coordinating the venezuelan equine encephalitis epizootic and epidemic with the u.s. department of agriculture veterinary services earned him the united states department of agriculture's outstanding service award. the veterinarians service to public health in the th century resulted in better health in all humans and animals. what are the st century challenges? animal medicine and veterinary public health have been intertwined since humans first began ministrations to their families and animals. dr. william foege, former director of the communicable disease center and professor at emory school of public health and now consultant to the bill gates foundation center, expressed this more forcefully in saying that we cannot have good public health unless we have good animal health. we can invert that and say we cannot have good animal health unless we have good public health. in the united states, the veterinary medical profession has carried on effectively in eliminating those major problems of animal health that had serious public health ramifications, namely bovine tuberculosis and brucellosis. in recent years the advances in rabies immunization have eliminated the disease from our pets, and humans have benefitted. the new human cases that occur are mainly the result of bat exposure. looking beyond that, we can see there is a sizable list of parasitic diseases, namely trichinosis and tapeworms, that have been brought under control in the united states. however, tapeworms are now being introduced by the recruitment of workers from mexico, central america and south america. these problems affect society in the united states, but it is apparent that we have an obligation to share our knowledge with our neighbors of the americas as well as africa and asia. all of these countries face the same problems the united states, solved in the past century. now as we move into the st century, the technology for controlling these diseases is available. these proven effective procedures in the united states can be used worldwide. some challenges exist, however, for methods that control bovine tuberculosis. there is a continuous demand for vaccines to prevent tuberculosis in animals, but there is little evidence there is any value in routine vaccination. these procedures are quite costly, and the best examples are in europe in the past years. after world war ii, tuberculosis was a major problem in central europe especially in germany, eastern europe, what is now russia, and western europe. there has been an uncalled-for degree of confidence in the tuberculosis vaccine, bcg, but with constant pressure from the world health organization, the world animal health organization (oie), the food and agricultural organization and united states agencies and consultants, the use of vaccines has been put aside. the old test and removal strategies have proven to be the most successful. to introduce that method into mexico, central america, south america and asia is difficult at this time because they are hopeful that a good vaccine will be developed. unfortunately we have lived with that hope for years. the major problem that remains is to compensate farmers for diseased animals that are removed. the neighboring countries of mexico, central america and south america have the opportunity to further their own disease control by employing the proven techniques used in the united states, canada and europe. the control of brucellosis in the developing world is a much bigger problem than tuberculosis. in veterinary epidemiologist george baer described the human disease in mexico and said that most rural people who had reached the age of had evidence of past infection with brucellosis. the same can be said for the countries of latin america where goats have a high rate of b. melitensis infections. to control b. melitensis is a difficult task and is a matter of the governments facing up to the issue. a new vaccine developed in the united states, the rb rough strain, had been researched for years or more before the united states department of agriculture veterinarians were able to find a solution to producing an effective vaccine for cattle. the vaccines have not proven valuable for goats and sheep. the control of widespread brucellosis in north africa and the middle east across asia has been given little attention. the who, through their consultancies and expert committees on rabies, has spread the knowledge of dog vaccination throughout the world. we can say with some degree of pride that the technology developed by veterinarians at the communicable disease center and carried to other parts of the world by authorities such as the late ernie tierkel and others who worked with him and george baer have made a great contribution to the world scene. we do see the light at the end of the tunnel for worldwide control of canine rabies. other efficient rabies vaccines have been developed in south america and europe. looking at the parasitic infections of the world, there is certainly a great deal of interest in control of trichinosis, which has been fostered through scientific congresses every few years. the world wide results are favorable today with a drastic reduction in north america and europe. unfortunately new problems have arisen in connection with the disease in wild animals, especially those found in the arctic zones of the world. taenia saginata and t. solium are receiving more attention as we face worldwide problems with the measurements of disease. in the americas the problem has been carried from one country to another by human carriers and then spread to animals. new foci have been established in north america, where there have been meetings to plan for initiating a worldwide control program. in my own way of thinking, the control of t. saginata is a measurement of good hygiene and good waste control in any country where it is present. dr. peter schantz has advocated world control of tapeworm and hydatid disease with the goal of eradication. many other new problems arising in zoonotic and parasitic diseases are constantly coming to our attention. the continuous migration of workers seeking better opportunities in industrialized countries also carries the risk of infections being brought with them. the surgeon general has spoken for the globalization of public health. the veterinary public health program of the cdc has been active in globalization of veterinary public health, namely in the control of rabies, parasitic diseases and food borne diseases. many of the veterinary officers have served on who expert zoonosis committees have carried out detailed missions for who. the cdc program has been supportive of paho veterinary activities with assignments of veterinary officers to mexico, panama, peru, argentina, and most recently david ashford and hugh mainzer to brazil for foot and mouth disease control and other problems. the number of emerging diseases increased in the latter part of the th century. infectious disease scientists have found that acquired immune deficiency syndrome (aids) is a disease that makes people more susceptible to zoonotic diseases, including bovine tuberculosis and related mycobacterial infections, toxoplasmosis, cryptosporidiosis, food borne salmonella and enteric infections including campylobacter, listeria and yersinia. it is possible that other zoonotic diseases that are dormant or infrequent may emerge in individuals with aids, human immunodeficiency virus infection, or other immune-compromised conditions. related latent or nonpathogenic viral diseases have been described in tropical cats of africa including lions as well as domesticated cats. in australia and malaysia new diseases which also affect humans have been reported in horses and swine. these diseases are caused by the morbilliviruses, a measles-like virus that causes canine distemper and rinderpest. another virus that killed the wild felids in the cairo zoo has not been identified. could this be another form of distemper? some of the emerging viral diseases that have a rodent or unknown animal host have caused fatal, devastating diseases in humans in africa and south america, namely lassa fever and south american hemorrhagic diseases in argentina and bolivia. in africa, ebola virus hemorrhagic fever and marburg hemorrhagic fever virus infection, linked to monkey disease, caused disease in medical personnel, handlers and people who had only casual exposure. an incident that surprised us many years ago was the deaths of workers in middle east abattoirs caused by crimean hemorrhagic fever carried by ectoparasites. one example of developing, emerging, or relatively unknown diseases is severe acute respiratory syndrome (sars), a disease that erupted a few years ago in china and was carried to many parts of the world. recently information has suggested that bats are a natural reservoir of a sars like coronavirus. even though sars may have been an occasional emerging disease that disappeared as rapidly as it appeared, there may have been other infections from bats that have been around the world for millenia. naturally, an infection that has been given much attention now is where we stand with the influenza virus. are wild birds the true reservoir? apparently, birds are the reservoir based on the information we have gathered showing that wild birds transmitted the virus to avian domestic flocks. all this new information is challenging. the emerging diseases of the world are reasonably covered in the table of the last chapter of merck veterinary manual's ninth edition zoonosis section, . in addition to infectious diseases, we have a new class of diseases that are caused by prionsproteinaceous infectious parties that transfer diseases without any dna or rna. transmissible diseases are not the same as infectious diseases which are characterized by replication of dna or rna. this is certainly a bewildering situation especially when we read that saliva may be a means of transfer. immediately veterinarians think of rabies which is transmitted by saliva. is it possible the prion of the diseased brain can be secreted through nerve fibers that innervate the salivary gland? the prions are of great and continuing concern as a cause of concern as new types of diseases. our associates in chemistry, physics, and physiology may offer clues to other neurological diseases. one last subject i want to mention is humaneness. it is important that we abide by sensible, humane policies, but humaneness can be carried to such an extreme that it destroys values that we hold so high for protecting our pets, farm animals, and the wild animals around us. periodically we all read about overpopulations in different areas. society calls for conservative measures for population control that applies to all pets, wild animals and domestic animals. in a broader sense, it has applications to the human race. we are aware of the collapse of earlier civilizations that have overpopulated their given area or were destroyed by natural events such as starvation. so i say all veterinarians, especially those in public health, have a responsibility in developing humane regulations for animal population control and public guidance. in the united states, - % of veterinarians treat our animal associates or pets for various diseases. it is important that veterinarians have a broad, basic knowledge of public health issues and are alert for new public health issues that can be resolved with tender loving care, new antibiotics, and new procedures. the , or more veterinarians in the avma in the united states are key to the control of zoonotic diseases by public health agencies. the health of our animal population is tied to the emotional and mental well being of those humans who are close to animals in their lives. animals are vital companions to those homebound, and animal health becomes a family concern. an area i have stressed is the need for basic veterinary science. we see in current publications that most research is based on support from nih. at the avma meeting in july , the speaker us senator hatch of utah spoke highly of the public health activities of veterinary medicine. he went on to say that there may be a nih veterinary institute in the future. it behooves us all that the agricultural interest in public health be recognized as an important issue to the american public. i think highly of the importance of animal health in providing good public health. public health should not be guided by economic interest but by the welfare of all society. i go back to my earlier statement that animal health and public health are of great importance to all, and we must have good animal health to have good public health. good public health provides a means for good animal health. as we look to the future, we have to have open minds and think in terms that anything can occur in biology. i would like to quote my dean from michigan state, ward giltner, who said the only thing about biology we can accept that remains a firm truth is there always is new information that provides exceptions. looking at it broadly, all infectious things in nature, and prions which may cause disease are always looking for a new host. i like to say they are seeking social security, as most of the world is. carry on in the st century. i wish i could continue to be a part of it, but it seems time has a way of saying, ''you have been here. you have enjoyed it.'' i especially enjoy the recognition of years of public health service, i am elated. to the audience, especially to the teachers of public health science, thank you. carry on. dr. steele does not have a financial or personal relationship with other people or organisations that could inappropriately influence or bias the paper entitled ''veterinary public health: past success, new opportunities.'' zoonoses and communicable diseases common to man and animals. pan american health organization viral scientist dies-public health giant handbook of zoonoses section a: bacterial, rickettsial, chlamydial and mycotic. section b: viral, second ed epidemic food-borne listeriosis in western switzerland. ii. epidemio ogy the relation of animal diseases to the public health and their prevention listeriosis visceral larva migrans cutaneous larva migrans guns, germs, and steel: the fates of human societies pasteurized milk as a vehicle of infection in an outbreak of listeriosis a profile of the us public health service - . pub. no. nih- - . us department of health, education and welfare. us government printing office leptospiral serotype distribution lists (through ). veterinary public health laboratory. us department of health, education, and welfare public health service the world problem of salmonellosis prevention of trichinosis by gamma irradiation of pork as a public health measure control of trichinosis by gamma irradiation of pork undulant fever outbreak at michigan state college. mich world's debt to pasteur report on diseases of domestic animals epidemic listeriosis associated with mexican-style cheese the animal kingdom-a reservoir of disease history of medical research and public health: an oral interview history of the bureau of animal industry, appendix man's greatest victory over tuberculosis. c.c. thomas attempts to control tuberculosis among cattle water borne outbreak of brucella melitensis infection plague milk and its relation to public health karl friedrich meyer - : a biographical memoir epidemic listeriosis: evidence for transmission by food food safety veterinary medicine and human health listeriosis the jungle. double, page & company the veterinarian in america - the socioeconomic responsibilities of veterinary medicine biographical notes on the occasion of karl f. meyer's th birthday trichinosis zoonoses - : an update of james law's report on diseases of animals epidemiology of food borne salmonellosis present status of anthrax rabies: problems and control. a nationwide program nurture turned to poison a new species of brucella isolated from the desert wood rat neotoma lepida (thomas) the epizootiology of bovine leptospirosis in washington leptospiral serotype distribution lists ( to ). veterinary public health laboratory. us department of health, education, and welfare public health service a century's progress in public health effective control of an outbreak of rabies in memphis and shelby county a brief survey and progress report of controlled comparative experiments in canine rabies immunization leptospirosis milk ordinance and code. public health bulletin no. . department of the treasury joint who/fao expert group on rabies. who technical report series no. . who joint who/fao expert group on zoonoses: bovine tuberculosis, q fever, anthrax who, . joint who/fao expert committee on zoonoses, report on the nd session. who technical report series no. . who, geneva. who, . joint who/fao expert committee on zoonoses trichiniasis in the u.s. population, - . prevalence and epidemiologic factors the symposium at which this paper was presented was sponsored by bayer animal health. the author also wishes to acknowledge and thank dr. cynthia hoobler for assistance with the preparation of this paper. key: cord- - q eg z authors: keller, mikaela; blench, michael; tolentino, herman; freifeld, clark c.; mandl, kenneth d.; mawudeku, abla; eysenbach, gunther; brownstein, john s. title: use of unstructured event-based reports for global infectious disease surveillance date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: q eg z free or low-cost sources of unstructured information, such as internet news and online discussion sites, provide detailed local and near real-time data on disease outbreaks, even in countries that lack traditional public health surveillance. to improve public health surveillance and, ultimately, interventions, we examined primary systems that process event-based outbreak information: global public health intelligence network, healthmap, and epispider. despite similarities among them, these systems are highly complementary because they monitor different data types, rely on varying levels of automation and human analysis, and distribute distinct information. future development should focus on linking these systems more closely to public health practitioners in the field and establishing collaborative networks for alert verification and dissemination. such development would further establish event-based monitoring as an invaluable public health resource that provides critical context and an alternative to traditional indicator-based outbreak reporting. i nternational travel and movement of goods increasingly facilitates the spread of pathogens across and among nations, enabling pathogens to invade new territories and adapt to new environments and hosts ( ) ( ) ( ) . offi cials now need to consider worldwide disease outbreaks when determining what potential threats might affect the health and welfare of their nations ( ) . in industrialized countries, unprecedented efforts have built on indicator-based public health surveillance, and monitoring of clinically relevant data sources now provides early indication of outbreaks ( ) . in many countries where public health infrastructure is rudimentary, deteriorating, or nonexistent, efforts to improve the ability to conduct electronic disease surveillance include more robust data collection methods and enhanced analysis capability ( , ) . however, in these parts of the world, basing timely and sensitive reporting of public health threats on conventional surveillance sources remains challenging. lack of resources and trained public health professionals poses a substantial roadblock ( ) ( ) ( ) . furthermore, reporting emerging infectious diseases has certain constraints, including fear of repercussions on trade and tourism, delays in clearance through multiple levels of government, tendency to err on the conservative side, and inadequately functioning or nonexistent surveillance infrastructure ( ) . even with the recent enactment of international health regulations in , no guarantee yet exists that broad compliance will be feasible, given the challenges associated with reporting mechanisms and multilateral coordination ( ) . in many countries, free or low-cost sources of unstructured information, including internet news and online discussion sites (figure) , could provide detailed local and near real-time data on potential and confi rmed disease outbreaks and other public health events ( , , ( ) ( ) ( ) ( ) ( ) ( ) . these eventbased informal data sources provide insight into new and ongoing public health challenges in areas that have limited or no public health reporting infrastructure but have the highest risk for emerging diseases ( ) . in fact, event-based informal surveillance now represents a critical source of epidemic intelligence-almost all major outbreaks investigated by the world health organization (who) are fi rst identifi ed through these informal sources ( , ) . with a goal of improving public health surveillance and, ultimately, intervention efforts, we (the architects, developers, and methodologists for the information systems described herein) reviewed of the primary active systems that process unstructured (free-text), event-based information on disease outbreaks: the global public health intelligence network (gphin), the healthmap system, and the epispider project (semantic processing and integration of distributed electronic resources for epidemics [and disasters]; www.epispider.net). our report is the result of a joint symposium from the american medical informatics association annual conference in . despite key differences, all systems face similar technologic challenges, including ) topic detection and data acquisition from a high-volume stream of event reports (not all related to disease outbreaks); ) data characterization, categorization, or information extraction; ) information formatting and integration with other sources; and ) information dissemination to clients or, more broadly, to the public. each system tackles these challenges in unique ways, highlighting the diversity of possible approaches and public health objectives. our goal was to draw lessons from these early experiences to advance overall progress in this recently established fi eld of event-based public health surveillance. after summarizing these systems, we compared them within the context of this new surveillance framework and outlined goals for future development and research. background gphin took early advantage of advancements in communication technologies to provide coordinated, near real-time, multisource, and multilingual information for monitoring emerging public health events ( , ) . in , a prototype gphin system was developed in a partnership between the government of canada and who. the objective was to determine the feasibility and effectiveness of using news media sources to continuously gather information about possible disease outbreaks worldwide and to rapidly alert international bodies of such events. the sources included websites, news wires, and local and national newspapers retrieved through news aggregators in english and french. after the outbreak of severe acute respiratory syndrome (sars), a new, robust, multilingual gphin system was developed and was launched november , , at the united nations. the gphin software application retrieves relevant articles every minutes ( hours/day, days/week) from news-feed aggregators (al bawaba [www.albawaba.com] and factiva [www. factiva.com]) according to established search queries that are updated regularly. the matching articles are automatically categorized into > gphin taxonomy categories, which cover the following topics: animal, human, or plant diseases; biologics; natural disasters; chemical incidents; radiologic incidents; and unsafe products. articles with a high relevancy score are automatically published on the gphin database. the gphin database is also augmented with articles obtained manually from openaccess web sites. each day, gphin handles ≈ , articles. this number drastically increases when events with serious public health implications, such as the fi nding of melamine in various foods worldwide, are reported. although the gphin computerized processes are essential for the management of information about health threats worldwide, the linguistic, interpretive, and analytical expertise of the gphin analysts makes the system successful. articles with relevancy below the "publish" threshold are presented to a gphin analyst, who reviews the article and decides whether to publish it, issue an alert, or dismiss it. additionally, the gphin analyst team conducts more in-depth tasks, including linking events in different regions, identifying trends, and assessing the health risks to populations around the world. english articles are machine-translated into arabic, chinese (simplifi ed and traditional), farsi, french, rus- sian, portuguese, and spanish. non-english articles are machine-translated into english. gphin has adopted a best-of-breed approach in selecting engines for machine translation. the lexicons associated with the engines are constantly being improved to enhance the quality of the output. as such, the machine-translated outputs are edited by the appropriate gphin analysts. the goal is not to obtain a perfect translation but to ensure comprehensibility of the essence of the article. users can view the latest list of published articles or query the database by using both boolean and translingual metadata search capabilities. in addition, notifi cations about events that might have serious public health consequences are immediately sent by email to users in the form of an alert. as an initial assessment of data collected during july through august , who retrospectively verifi ed outbreaks, of which % were initially picked up and disseminated by gphin ( ) . outbreaks were reported in countries, demonstrating gphin's capacity to monitor events occurring worldwide, despite the limitation of predominantly english (with some french) media sources. one of gphin's earliest achievements occurred in december , when the system was the fi rst to provide preliminary information to the public health community about a new strain of infl uenza in northern people's republic of china ( ) . during the sars outbreak, declared by who in march , the gphin prototype demonstrated its potential as an early-warning system by detecting and informing the appropriate authorities (e.g., who, public health agency of canada) of an unusual respiratory illness outbreak occurring in guangdong province, china, as early as november , . gphin was further able to continuously monitor and provide information about the number of suspected and probable sars cases reported worldwide on a near real-time basis. gphin's information was ≈ - days ahead of the offi cial who report of confi rmed and probable cases worldwide. in addition to outbreak reporting, gphin has also provided information that enabled public health offi cials to track global effects of the outbreak such as worldwide prevention and control measures, concerns of the general public, and economic or political effects. gphin is used daily by organizations such as who, the us centers for disease control and prevention (cdc), and the un food and agricultural organization. operating since september , healthmap ( , ) is an internet-based system designed to collect and display information about new outbreaks according to geographic location, time, and infectious agent ( ) ( ) ( ) . healthmap thus provides a structure to information fl ow that would otherwise be overwhelming to the user or obscure important elements of a disease outbreak. healthmap.org receives , - , visits/day from around the world. it is cited as a resource on sites of agencies such as the united nations, national institute of allergy and infectious diseases, us food and drug administration, and us department of agriculture. it has also been featured in mainstream media publications, such as wired news and scientifi c american, indicating the broad utility of such a system that extends beyond public health practice ( , ) . on the basis of usage tracking of healthmap's internet site, we can infer that its most avid users tend to come from government-related domains, including who, cdc, european centre for disease prevention and control, and other national, state, and local bodies worldwide. although the question of whether this information has been used to initiate action will be part of an in-depth evaluation, we know from informal communications that organizations (ranging from local health departments to such national organizations as the us department of health and human services and the us department of defense) are leveraging the healthmap data stream for day-to-day surveillance activities. for instance, cdc's biophusion program incorporates information from multiple data sources, including media reports, surveillance data, and informal reports of disease events and disseminates it to public health leaders to enhance cdc's awareness of domestic and global health events ( ) . the system integrates outbreak data from multiple electronic sources, including online news wires (e.g., google news), really simple syndication (rss) feeds, expertcurated accounts (e.g., promed-mail, a global electronic mailing list that receives and summarizes reports on disease outbreaks) ( ) , multinational surveillance reports (e.g., eurosurveillance), and validated offi cial alerts (e.g., from who). through this multistream approach, healthmap casts a unifi ed and comprehensive view of global infectious disease outbreaks in space and time. fully automated, the system acquires data every hour and uses text mining to characterize the data to determine the disease category and location of the outbreak. alerts, defi ned as information on a previously unidentifi ed outbreak, are geocoded to the country scale with province-, state-, or city-level resolution for select countries. surveillance is conducted in several languages, including english, spanish, russian, chinese, and french. the system is currently being ported to other languages, such as portuguese and arabic. after being collected, the data are aggregated by source, disease, and geographic location and then overlaid on an interactive map for user-friendly access to the original report. healthmap also addresses the computational challenges of integrating multiple sources of unstructured information by generating meta-alerts, color coded on the basis of the data source's reliability and report volume. although information relating to infectious disease outbreaks is collected, not all information has relevance to every user. the system designers are especially concerned with limiting information overload and providing focused news of immediate interest. thus, after a fi rst categorization step into locations and diseases, a second round of category tags is applied to the articles to improve fi ltering. the primary tags include ) breaking news (e.g., a newly discovered outbreak); ) warning (initial concerns of disease emergence, e.g., in a natural disaster area; ) follow-up (reference to a past outbreak); ) background/context (information on disease context, e.g., preparedness planning); and ) not disease-related (information not relating to any disease [ - are fi ltered from display]). duplicate reports are also removed by calculating a similarity score based on text and category matching. finally, in addition to providing mapped content, each alert is linked to a related information window with details on reports of similar content as well as recent reports concerning either the same disease or location and links for further research (e.g., who, cdc, and pubmed). healthmap processes an average of . most alerts come from news media ( . %), followed by promed ( . %) and multinational agencies ( . %). the epispider project was designed in january to serve as a visualization supplement to the promed-mail reports. through use of publicly available software, epispider was able to display topic intensity of promed-mail reports on a map. additonally, epispi-der automatically converted the topic and location information of the reports into rss feeds. usage tracking showed, initially, that the rss feeds were more popular than the maps. transforming reports to a semantic online format (w c semantic web) makes it possible to combine emerging infectious disease content with similarly transformed information from other internet sites such as the global disaster alert coordinating system (gdacs) website (www.gdacs.org). the broad effects of disasters often increase illness and death from communicable diseases, particularly where resources for healthcare infrastructure have been lacking ( , ) . by merging these online media sources (promed-mail and gdacs), epispider demonstrates how distributed, event-based, unstructured media sources can be integrated to complement situational awareness for disease surveillance. epispider connects to news sites and uses natural language processing to transform free-text content into structured information that can be stored in a relational database. for promed reports, the following fi elds are extracted: date of publication; list of locations (country, province, or city) mentioned in the report; and topic. epispider parses location names from these reports and georeferences them using the georeferencing services of yahoo maps (http:// maps.yahoo.com), google maps (http://maps.google.com), and geonames (www.geonames.org). each news report that has location information can be linked to relevant demographic-and health-specifi c information (e.g., population, per capita gross domestic product, public health expenditure, and physicians/ , population). epispider extracts this information from the central intelligence agency (cia) factbook (www.cia.gov/library/publications/the-world-factbook/index.html) and the united nations development human development report (http://hdr.undp.org/en) internet sites. this feature provides different contexts for viewing emerging infectious disease information. by using askmedline ( ) , epispider also provides context-sensitive links to recent and relevant scientifi c literature for each promed-mail report topic. after epispider extracts the previously described information, it automatically transforms it to other formats, e.g., rss, keyhole markup language(kml; http://earth.google.com/ kml), and javascript object notation (json, a human-readable format for representing simple data structures; www. json.org). publishing content using those formats enables the semantic linking of promed-mail content to country information and facilitates epispider's redistribution of structured data to services that can consume them. continuing along this transformation chain, the simile exhibit api (http://simile.mit.edu) that consumes json-formatted data fi les enables faceted browsing of information by using scatter plots, google maps, and timelines. recently, epispider began outsourcing some of its preprocessing and natural language processing tasks to external service providers such as opencalais (www.opencalais.com) and the unifi ed medical language system (umls) web service for concept annotation. this action has enabled the screening of noncurated news sources as well. built on open-source software components, epispi-der has been operational since january . in response to feedback from users, additional custom data feeds have been incorporated, both topic oriented (by disease) and format specifi c (kml, rss, georss), as has semantic annotation using umls concept codes. for example, the epispider kml module was developed to enable the us directorate for national intelligence to distribute avian infl uenza event-based reports in google earth kml format to consumers worldwide and also to enable an integrated view of promed and world animal health information database reports. epispider is used by persons in north america, europe, australia, and asia, and it receives - visits/hour, originating from - sites and representing - countries worldwide. epispider has recorded daily visits from the us department of agriculture, us department of homeland security, us directorate for national intelligence, us cdc, uk health protection agency, and several universities and health research organizations. in the latter half of , daily access to graphs and exhibits surpassed access to data feeds. epispider's semantically linked data were also used for validating syndromic surveillance information in openrods (http://openrods. sourceforge.net) and populating disease detection portals, like www.intelink.gov and the research triangle institute (research triangle park, nc, usa). despite their similarities, the described event-based public health surveillance systems are highly complementary; they monitor different data types, rely on varying levels of automation and human analysis, and distribute distinct information. gphin, being the longest in use, is probably the most mature in terms of information extraction. in contrast, healthmap and epispider, being comparatively recent programs, focus on providing extra structure and automation to the information extracted. their differences and similarities, summarized in the table, can be analyzed according to multiple characteristics: what data sources do they consider? how do they extract information from those sources? and in what format is the information redistributed and how? for completeness, the broadest range of sources is critical. gphin's data comes from factiva and al bawaba, which are subscription-only news aggregators. their strategy is to rely on companies that sell the service of collecting event information from every pertinent news stream. in contrast, healthmap's strategy is to rely on open-access news aggregators (e.g., googlenews and moreover) and curated sources (e.g., promed and eurosurveillance). epispider, until recently, has concentrated on curated sources only (e.g., promed, gdacs, and cia factbook). this distinction between free and paid sources raises the question of whether the systems have access to the same event information. after the data sources have been chosen, the next step is to extract useful information among the incoming reports. first, at the level of the report stream, the system must fi lter out reports that are not disease related and categorize the remaining (disease-related) reports into predefi ned sets. then, at a second level of triage, the information within each retrieved alert (e.g., an event's location or reported disease) is assessed. gphin does this data characterization through automatic processing and human analysis, whereas healthmap and epispider rely mainly on automated techniques (although a person per- forms a daily scan of all healthmap alerts and a sample of epispider alerts). after a report in the data stream is determined to be relevant, it is processed for dissemination. gphin automatically translates the reports into different languages and grants its clients access to the database through a custom search engine. gphin also decides which reports should be raised to the status of alerts and sent to its clients by email. healthmap provides a geographic and temporal panorama of ongoing epidemics through an open-access user interface. it automatically fi lters out the reports that do not correspond to breaking alerts. the remaining alerts are prepared for display (time codes and geocodes as well as disease category and data source) to allow faceted browsing and are linked to other information sources (e.g., the wikipedia defi nition of the disease). these data are also provided as daily email digests to users interested in specifi c diseases and locations. although gphin and health-map provide their own user interface, epispider explores conventional formats for reports, adding time-coding, geocoding, and country metadata for automatic integration with other information sources and versatile browsing by using existing open-source software. these reports are displayed under the name of web exhibits and include, for example, a mapping and a timeline view of the reports and a scatter plot of the alerts with respect to the originating country's human development index and gross domestic product per capita. a division arises between the healthmap and epispi-der strategies and the gphin strategy regarding the level of access granted to users. this division is due in part to the access policies of the data sources used by the systems, as discussed previously. a discrepancy also exists in the amount of human expertise, and thus in the cost, required by the systems. these differences also raise the question of whether information from one system is more reliable than that of the others. undertaking an evaluation of the systems in parallel is a critical next step. also, all systems are inherently prone to noise because most of the data sources they use or plan to use (figure) for surveillance are not verifi ed by public health professionals, so even if the system is supervised by a human analyst, it might still generate false alerts. false alerts need to be mitigated because they might have substantial undue economic and social consequences. eventbased disease surveillance may also benefi t from algorithms linked by ontology (formal representation of a set of concepts within a domain and the relationships between those concepts) detecting precursors of disease events. measurement and handling of input data's reliability is a critical research direction. future development should focus on linking these systems more closely to public health practitioners in the fi eld and establishing collaborative networks for alert verifi cation and dissemination. such development would ensure that event-based monitoring further establishes itself as an invaluable public health resource that provides critical context and an alternative to more traditional indicator-based outbreak reporting. emerging and re-emerging infectious diseases emerging infections: microbial threats to health in the united states travel and the emergence of infectious diseases the 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internet and the global monitoring of emerging diseases: lessons from the fi rst years of promed-mail global trends in emerging infectious diseases the global public health intelligence network the global public health intelligence network and early warning outbreak detection: a canadian contribution to global public health healthmap: internet-based emerging infectious disease intelligence. in: infectious disease surveillance and detection: assessing the challenges-fi nding solutions. washington: national academy of science surveillance sans frontières: internet-based emerging infectious disease intelligence and the healthmap project world wide wellness: online database keeps tabs on emerging health threats technology and public health: healthmap tracks global diseases get your daily plague forecast public health information fusion for situation awareness the threat of communicable diseases following natural disasters: a public health response infectious diseases of severe weather-related and fl ood-related natural disasters askmedline: a free-text, natural language query tool for medline/pubmed use of trade names is for identifi cation only and does not imply endorsement by the public health service or by the key: cord- -a mnjr s authors: lee, a. title: wuhan novel coronavirus (covid- ): why global control is challenging? date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: a mnjr s nan wuhan novel coronavirus : why global control is challenging? on december , the world health organization (who) was alerted to the emergence of cases of pneumonia of unknown etiology detected in wuhan city, china. within days, chinese health authorities identified more cases. a novel coronavirus (covid- ) was subsequently isolated from patients. a putative epidemiological link was made with exposures in a seafood market in wuhan city. by the end of january , cases of -ncov were confirmed throughout china, with further , suspected cases and deaths. more worryingly, cases were also confirmed abroad in countries, from neighboring countries such as japan and vietnam to more distant countries such as finland, canada, and australia. on january , the emergency committee of the who, under the international health regulations, declared covid- acute respiratory disease a public health emergency of international concern. at this stage, the global spread of covid- acute respiratory disease continues to grow, and the full extent and severity of this outbreak remains to be seen. that said, global disease control of covid- is likely to be challenging. experience from the severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers) outbreaks, both also caused by emerging novel coronaviruses, may be informative. firstly, the rapid spread of covid- is likely to be driven by the phenomenon of 'superspreading'. superspreading describes heightened transmission of the disease to at least eight contacts and has been observed for several infectious diseases including sars, mers, and influenza. , any delay in recognition of the disease and implementation of effective control measures increases the likelihood of greater spread of the pathogen. another feature of covid- common to sars and mers is the rapidity of global spread due to commercial air travel. the spanish influenza pandemic took months to spread from europe to australia or south america as ship-borne travel took time. modern air travel allows passengers to traverse the globe in less than a day. this allows the viruses to rapidly spread across continents, and efforts at airport screening to halt them have been fairly ineffective and costly. , this is in addition to the potential for in-flight transmission of the virus among passengers that was observed with sars. once the pathogen has landed in a new country, the likelihood of contagion and spread is dependent on local transmission pathways and the strength of local health protection systems. experience from mers suggests the transmissibility of the virus is not just due to its inherent infectivity but also due to influence by local contextual variables such as hygiene practices, crowding, and infection control standards. high-income countries such as the united states and united kingdom have well-developed health protection systems to detect and respond to communicable disease threats. they have the ability to robustly trace contacts, assess suspected cases, and have them tested rapidly to get timely laboratory confirmation of infectious status to guide the management of these individuals. infected individuals identified can then be isolated until the risk of disease transmission has abated. this containment strategy, however, is resource intensive and may be more difficult to enforce in liberal democracies. the other component of well-developed health protection systems are strong infectious disease surveillance systems. surveillance enables the disease to be detected, outbreaks to be tracked, and the efficacy of interventions to be monitored. it also can provide vital information on the characteristics of the pathogen and help identify vulnerable population groups. during an outbreak of this significance, active surveillance is likely to be instituted, often with daily monitoring of disease trends demanded by health authorities. once again, this is laborious and resource intensive. the current concerns then regarding the -ncov outbreak must be for low-and middle-income countries where health protection systems tend to be weaker. in these settings, laboratory resources may be lacking, notification of infectious diseases are often not timely or complete, and their public health infrastructure is often weak. their surveillance systems may be more rudimentary, lacking in coverage and analytical strength. , surveillance systems are the eyes of the health system e without them the health system would be blind. you cannot tackle what you cannot see. unfortunately, in resource-constrained settings, investment in this critical health protection infrastructure is a low priority compared with other health priorities. health protection investment is analogous to an insurance policy e in good times when it is infrequently called upon it may be deemed unnecessary by policymakers. but this is a dangerous misperception. furthermore, compared with other public health interventions, health protection interventions are highly cost-effective. disinvestment in health protection is risky as it is not easy to build up health protection infrastructure, skills, and workforce rapidly. consequently, the risk of covid- is most likely to be greatest in developing countries that are most likely to lack the means and health protection systems to protect themselves. the burden of infection may, therefore, be heaviest in these countries. undoubtedly, most developed countries would be focused on preparing their health systems to protect their own health security. however, without adequate intervention in the developing countries, covid- could take root and become endemic in these countries, in effect becoming human population reservoirs for the virus that can and will reinfect other populations worldwide. there is therefore both a self-preservation and a moral imperative for richer public health jo u rn a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / p u h e countries to offer and provide assistance to developing countries to help them bolster their defenses against this global threat. what is clear is that global health threats such as covid- will require collaborative solutions by the international community. the global covid- outbreak story could have several different endings. with a degree of luck, the best-case scenario may be covid- spontaneously petering out as was the case with sars in . or it may continue to sporadically pop up over many years with the occasional outbreak as mers has done. or, more worryingly, it may follow a more sinister path such as the spanish influenza and take root in populations worldwide, exacting a heavy toll in morbidity and mortality over decades to come. the initial signs are worrying e early estimates put its reproductive number at . with a case fatality rate around %, , not too dissimilar to the pandemic flu strain. only time will tell. -ncov) situation report - (website). who; . -ncov) situation report - (website). who; . superspreading sars events the role of superspreading in middle east respiratory syndrome coronavirus (mers-cov) transmission border screening for sars evaluation of border entry screening for infectious diseases in humans transmission of the severe acute respiratory syndrome on aircraft middle east respiratory syndrome coronavirus: risk factors and determinants of primary, household, and nosocomial transmission beyond traditional surveillance: applying syndromic surveillance to developing settingseopportunities and challenges global infectious disease surveillance and health intelligence communicable diseases surveillance lessons learned from developed and developing countries: literature review return on investment of public health in-terventions: a systematic review novel coronavirus -ncov: early estimation of epidemiological parameters and epidemic predictions clinical features of patients infected with novel coronavirus in wuhan transmissibility of pandemic influenza key: cord- -erlmyzwn authors: cabarkapa, sonja; nadjidai, sarah e.; murgier, jerome; ng, chee h. title: the psychological impact of covid- and other viral epidemics on frontline healthcare workers and ways to address it: a rapid systematic review date: - - journal: brain behav immun health doi: . /j.bbih. . sha: doc_id: cord_uid: erlmyzwn background: as the world is battling the covid- pandemic, frontline health care workers (hcws) are among the most vulnerable groups at risk of mental health problems. the many risks to the wellbeing of hcws are not well understood. of the literature, there is a paucity of information around how to best prevent psychological distress, and what steps are needed to mitigate harm to hcws’ wellbeing. methods: a systematic review using prisma methodology was used to investigate the psychological impact on hcws facing epidemics or pandemics, using three electronic databases (pubmed, medline and cinahl), dating back to until the st of august . the search strategy included terms for hcws (e.g., nurse and doctor), mental health (e.g., wellbeing and psychological), and viral outbreaks (e.g., epidemic and pandemic). only studies with greater than frontline hcws (i.e. doctors or nurses in close proximity to infected patients) were included. results: a total of studies were included, with using quantitative methodology and were qualitative. of the quantitative studies used validated measurement tools while used novel questionnaires. the studies were conducted across various countries and included people with sars ( studies), ebola ( ), mers ( ) and covid- ( ). findings suggest that the psychological implications to hcws are variable with several studies demonstrating an increased risk of acquiring a trauma or stress-related disorders, depression and anxiety. fear of the unknown or becoming infected were at the forefront of the mental challenges faced. being a nurse and being female appeared to confer greater risk. in past epidemics, the perceived stigma from family members and society heightened negative implications; predominantly stress and isolation. coping strategies varied amongst the contrasting sociocultural settings and appeared to differ amongst doctors, nurses and other hcws. implemented changes, and suggestions for prevention in the future consistently highlighted the need for greater psychosocial support and clearer dissemination of disease-related information. conclusion: this review can inform current and future research priorities in the maintenance of wellbeing amongst frontline hcws. change needs to start at the level of policy-makers to offer an enhanced variety of supports to hcws who play a critical role during largescale disease outbreaks. psychological implications are largely negative and require greater attention to be mitigated, potentially through the involvement of psychologists, raised awareness and better education. the current knowledge of therapeutic interventions suggests they could be beneficial but more long-term follow-up is needed. large-scale disease epidemics pose various challenges to individuals of all ages and cultures but the emotional stress experienced by frontline health care workers (hcws) is severe, and can be enduring. - the novel coronavirus (covid- ) which emerged in wuhan, china, led to a pandemic unlike any other in the last century. the subsequent demand placed on hcws is difficult to encompass in its entirety. even less is known about the implications for their mental health and well-being. evidence from studies during covid- and similar past epidemics can help inform this, and how best to address it. a pandemic is the worldwide spread of a new disease, otherwise known as an epidemic that has spread over several countries or continents. high global death toll, with thousands of hcws becoming infected. the fast changing response to this novel virus was likely to have had a profound effect on the wellbeing of hospital employees working on the front-line. furthermore, the rapid transmission rate of covid- led to unparalleled tasks that hcws may not have been adequately equipped to deal with, from both a professional and psychological viewpoint. dealing with a severe global health disaster is an uncharted journey into the unknown at various levels. government bodies make plans using other countries' data to project infection rates. the high degree of uncertainty associated to novel pathogens further j o u r n a l p r e -p r o o f contributes to the communal anxiety held, and makes for an overall negative experience for most. however, the challenge encountered can also result in positive changes, as individuals harness their coping skills, work together in teams, and the change instrumented by leaders can strengthen nations' preparedness against future disasters. in terms of mental health impact of epidemics, hcws represent a particularly vulnerable group due to the high risk of infection, increased work stress and fear of spreading to their families. during the recent ebola outbreak, an unprecedented number of hcws were infected , and survivors of infectious diseases have higher rates of post-traumatic stress disorder (ptsd). recommendations around the use of psychological first aid (pfa) have been made by global authorities. however, the efficacy of this strategy is not well studied and barriers to its application exist. , the many risks to the wellbeing of hcws are not well understood. post-sars, there has been some research into this area but little is known about the psychological impact during infectious disease outbreaks. detrimental outcomes such as burnout, traumatic stress, anxiety, and depressive symptoms have been reported even after an outbreak, suggesting long-term implications. given the likely increased rate of psychological problems amongst hcws, these factors must be addressed. in the context of the covid- pandemic, this timely review is both relevant and urgent. it is imperative that those working at the frontline with infected patients or in afflicted j o u r n a l p r e -p r o o f regions have the necessary strategies and resources to endure various challenges. there is a lack of systematic reviews published specifically on the mental health implications experienced by frontline hcws during an epidemic. of the literature, there is also a paucity of information around how to best prevent psychological distress, and what steps are needed to mitigate harm to hcws' wellbeing. the purpose of this review is to explore the main findings from the literature examining the psychological impact on hcws in times of severe epidemics, and to identify strategies to address this. we performed a systematic literature review to identify all international research related to epidemics and pandemics. specifically, we aimed to identify original research pertaining to severe viral outbreaks, from to the st of august . to obtain relevant articles, we systematically searched pubmed, medline and cinahl. the following search terms were used: 'health worker', 'health care worker', 'medical', 'doctor', 'nursing', 'nurse', 'allied health', 'pandemic', 'outbreak', 'mental health', 'mental illness', 'psychiatric', 'psychological', 'coping', 'psychosocial', 'covid- ', 'coronavirus', 'sars', 'mers' and 'ebola'. the references of identified articles were also manually searched for additional studies meeting study criteria. the studies included in this review had to be original research (i.e. commentaries, editorials and reviews were excluded), be published in peer-reviewed journals, be written in english, include frontline hcws as study participants, and include factors associated with their mental health or psychological wellbeing. as the clear majority of papers used self-reported measures, to ensure inclusion of high quality and adequately powered research, studies needed to include at least frontline hcws. hcws j o u r n a l p r e -p r o o f needed to be working in close proximity with infected patients. the initial search yielded , papers, of which included relevant data and were included in this review. the screening process is depicted in figure . one reviewer (sn) examined the titles and abstracts initially to yield the preliminary publications for inclusion ( ). two reviewers (sc and sn) examined the full text studies independently with identical study selection criteria and removed the articles ( ) that did not fulfil inclusion criteria. a third reviewer (cn) examined studies that required further consideration. the studies were conducted across various countries and included people with sars ( studies), ebola ( ), mers ( ) and covid- ( ) . of the articles, were quantitative and were qualitative. details of the characteristics are listed in table . of the quantitative studies, fifty studies - , - incorporated validated questionnaires or measurement tools, while five - used novel questionnaires. all the studies included in this review assessed the psychological impact of severe epidemics on hcws. the most common psychiatric disorders diagnosed were posttrauma stress syndrome (ptss), depression and anxiety, as assessed in studies. , , , - , - , - , , in the covid- pandemic, somatisation was reported frequently , , with . % ( , of , ) of frontline nurses identifying somatic symptoms , particularly headache, throat pain and lethargy, which were significantly associated with psychological outcomes. sleep disorders including insomnia were also frequently identified. , , , , , female nurses with close contact to covid- patients appeared to have the highest mental health risks , , however, it is important to note that most studies included predominantly female participants, especially nurses, with only one study suggesting higher stress levels amongst males. specifically, being female conferred greater risks for depression, anxiety and higher levels of stress , , [ ] [ ] [ ] suicidal ideation was identified amongst . % ( of , ) of hcws with lower self-perceived health status listed as an additional risk factor. , at the early stages of the covid- pandemic, a wuhan study found that . % ( of ) of medical and nursing staff had mild mental health disturbances while . % ( ) had severe disturbances, while in another study of , chinese hcws . % had psychological abnormalities. in the hubei province, . % ( of ) of medical staff had anxiety, being more severe in those with direct contact with infected patients. two-weeks after wuhan went into lockdown, the proportion of female hcws with depression, anxiety and acute stress symptoms were respectively . % ( of , ), . % ( ) and . % ( ). one study j o u r n a l p r e -p r o o f found a moderate degree of burnout amongst , hcws across two hospitals in wuhan, with high levels of fear reported. approximately % ( of ) of hcws had ptsd two months after the sars outbreak in singapore. while % ( of ) of staff members at a hospital in east taiwan met criteria for an acute stress disorder (asd) during the sars pandemic. similarly, hcws and other staff with direct contact or exposure to ebola patients, had a range of psychological symptoms, such as obsession-compulsion, interpersonal sensitivity, depression and paranoid ideation. during the -year period following their exposure to the sars outbreak, around % ( of ) of beijing hospital employees had a high degree of post-traumatic stress symptoms which were strongly associated with exposure to sars, quarantine and a relative or friend acquiring sars. a study of , hcws assessed the psychological impact in the initial stages of the mers outbreak and one month later. those who performed mers-related tasks reported greater distress and more intrusive phenomena. they also had the greatest risk for ptsd symptoms one-month later, and interestingly, this risk was increased even after home quarantine. home quarantined hcws had poorer sleep and a heightened degree of numbness than those who were not quarantined. in terms of impact on different health professionals, a recent study comparing medical hcws ( ) to non-medical hcws ( , ) demonstrated significantly higher levels of insomnia, anxiety, depression, somatization, and obsessive-compulsive symptoms in medical hcws. a spanish study also found that hcws ( ) had higher symptoms of acute stress than compared with non-hcws ( ). similarly, anxiety and insomnia were j o u r n a l p r e -p r o o f significantly higher in frontline hcws compared to non-frontline hcws. , , eight studies compared doctors and nurses , , , , , , , . four of these studies focused on sars and found that nurses experienced greater levels of stress. of these, one study reported higher distress for nurses and those with direct contact with infected patients. in two quantitative studies , from hong kong, overall distress level for nurses was significantly higher than for other hcws with the exception of doctors, and nurses also experienced higher levels of stress and psychological morbidity compared with other professionals. interestingly, one study of , nurses, showed that nurses in moderate-risk areas appeared to have more stress symptoms than those working in high-risk areas, but the reasons for this remain unclear. alternate findings were depicted in two studies , where doctors and single nurses were found to be at higher risk compared to nurses and those who were married, and doctors had more stress and anxiety compared to nurses. further, % of participants ( of ) had psychiatric symptoms, with the doctors being . times more likely to experience psychiatric symptoms than nurses, and % ( of ) had ptsd. in contrast, a study comparing hcws impacted by sars, found no significant difference in feelings of stress between the physicians, nurses and other hcws. an italian study hcws during the covid- pandemic, showed that general practitioners were more likely to have ptss than other hcws, while nurses and health care assistants were more likely to exhibit severe insomnia. similarly, another chinese study found that nurses ( ) working in the frontline against covid- experienced significantly greater levels of vicarious traumatisation when compared to non-frontline nurses ( ). this theme was replicated with findings to suggest that frontline hcws in close contact with j o u r n a l p r e -p r o o f infected patients were . times more likely to feel fear and twice more likely to suffer anxiety and depression when compared to non-clinical staff. in a study of , hcw's during the covid- outbreak, high rates of depression, anxiety and insomnia were reported with over % reporting psychological distress. a survey of chinese hcws during the covid- outbreak found that . % ( of , ) had symptoms of insomnia. a comparison of hcws in wuhan, the epicentre of the covid- outbreak, compared to those in a different province found that staff in wuhan had higher rates of insomnia and stress responses. one study compared hcws with healthy controls and found that hcws were not more stressed than controls the publications included in this review were predominantly focused on the stressors arising during an outbreak, however, six articles , , , , , focused either entirely on j o u r n a l p r e -p r o o f the period following the outbreak, or in part, had follow-up. two , articles examined predictors and one study considered the stressors before care was given. predictors of the incidence of new-onset episodes of psychiatric disorders after the sars outbreak included; a past history of psychiatric illness, years of health care experience (inversely associated) and the perception of adequate training and support. new episodes of psychiatric disorders occurred among % ( of ) of hcws. a greater degree of psychiatric morbidity was identified amongst nurses and younger hcws. taiwanese nurses found that the pre-care stage contributed to fear, as all ( ) reported having difficulties keeping up with daily changing knowledge and skills and being anxious about their safety and of their families, clients, and colleagues. participants across seventeen studies , , , , , , , , , - , , reported fear as the prominent stressor. particularly, fear of the unknown, becoming infected and threats to their own mortality. the vulnerability of colleagues and family member were also a major cause of concern as reported in an italian study , being exposed to contagion was associated with symptoms of depression, while having a colleague hospitalised or placed in quarantine was associated with ptss, whereas, a colleague dying was associated to depression and insomnia. a major theme was anxiety, especially across most of the covid- studies , - , , , , - , - . in a chinese study the most important factor in hcws with high anxiety was being suspected of having covid- infection when compared to those who were not suspected of infection. of , hcws in singapore, % perceived an increased j o u r n a l p r e -p r o o f risk of becoming infected, % reported work stress and % had increased workloads. doctors, nurses and staff in daily contact with sars patients, and staff from sarsaffected institutions expressed significantly higher levels of anxiety than other hcws. in questionnaires experienced psychological distress. similarly, a survey of hcws after the mers outbreak found that safety fears for themselves and others were a major concern, with worries that they would transmit the disease to their families and friends. all nurses ( ) responding to a qualitative study expressed that a lack of defensive protection against the disease, and difficulties keeping up with daily changing knowledge/skills contributed to fear. the media was also noted to play a role in amplifying uncertainty. ten studies , , , , , , , , , highlighted the importance of social support, with emphasis on the need for increased social support mechanisms and regular contact with families . a lack of family support and social isolation had a negative psychological impact on nurses who chose to isolate away from their families while treating sars patients. correspondingly, the lack of social support during the sars outbreak brought out discrimination from the community as well as distancing behavior from hcws' own families. a study of , nurses identified three attitudinal factors j o u r n a l p r e -p r o o f (health fear, social isolation and job stress) mediated the association between contact with sars patients and psychological stress. the levels of anxiety, stress, and selfefficacy exhibited amongst chinese hcws in wuhan during the covid- pandemic appeared dependent on their degree of social support and quality of sleep. stigma was a major factor identified across five studies , , , , , and during the covid- pandemic, it was associated to a higher risk of depressive symptoms . in a large-scale study of , hcws, % experienced social stigmatization and % ostracism by family members. analogous findings, amongst nurses ( ) during a mers outbreak in korea found that stigma contributed negatively to the mental health of nurses through a direct effect but also indirectly via stress. amongst hcws findings showed that % ( of ) felt stigmatized and rejected in their neighborhood because of their hospital work, and % ( of ) reported reluctance to work or had considered resignation. hcws often found themselves working under high levels of physical and psychological stress , sometimes attributed to work conditions. during the covid- pandemic, long work hours were found to increase stress levels amongst nurses. similarly, the burden of adhering to strict protective measures seemed to increase distress levels. the heavy protective gear was found to add to the physical difficulties of carrying out procedures. spanish hcws who perceived protection as insufficient rated higher levels of depression, anxiety and acute stress than those who perceived it to be adequate. contrastingly, findings from , hcws during the sars outbreak demonstrated that % reported that the personal protective measures implemented j o u r n a l p r e -p r o o f were effective, % felt that institutional policies and protocols were clear and % felt they were timely. similar findings were depicted by hcws who generally declared confidence in infection-control measures. measures to address the psychological risks to hcws during epidemics thirteen studies , , , , , , , , , , , , considered coping strategies, such as acceptance, resilience, active coping and positive framing. of hcws, doctors were significantly more likely than nurses and health care assistants (hcas) to use planning as a coping strategy, while nurses were more likely than doctors to use behavioural disengagement, and hcas were more likely than doctors to use selfdistraction. amongst american hcws, exercise was the most commonly used coping strategy ( %), and access to an individual therapist with online self-guided counselling ( %) generated the most interest. support from supervisors and colleagues was found to be a significant negative predictor for psychiatric symptoms and ptsd. further mental health predictors amongst a group of chinese emergency hcws included the tenacity, strength and the availability of support. in a study of hcws, psychological support and practical support with insurance and compensation matters had a protective effect against stress. in parallel with this, positive feedback emerged when counsellors asked the medical staff to share how they coped with this difficult situation. several studies , , , , identified a need for greater support through collaboration, training and education. this appeared to strengthen teams and have protective effects in reducing hcw stress as simple protective measures were reassuring for hcws . additionally, clear communication was seen to reduce psychiatric symptoms. the duration of follow-up was not specified in most studies and there was a lack of studies on the long term supports for hcws post-epidemic. while others emphasised the need for prompt and continuous psychiatric interventions in high mortality infectious disease outbreaks. , , , imminent utilisation of interventions promoting wellbeing for hcws facing covid- was suggested for frontline workers, females and nurses. furthermore, it is important that nurses are not stigmatised and policymakers should make efforts to ensure this stress is minimised and also allow them to focus on patient care. stigma could also be minimised through an integrated administrative and j o u r n a l p r e -p r o o f psychosocial response to challenges that are caused by outbreaks. there is a need for the development of prevention programs for stress related psychiatric disorders. in addition, health authorities should provide proactive psychological support for staff by offering support and training, counselling hotlines and offer reimbursements to staff. workplace awareness and measures many recommendations focused on enhanced awareness amongst authorities or hospital administrators of their employees' mental health. only two qualitative studies met inclusion criteria and the rest were quantitative studies. the majority of studies used online survey methodology and self-report measures which have inherent limitations. there was a lack of longitudinal studies and therefore little evidence on the long term psychological sequelae and treatment needs. further, indepth research considering the pre-and post-outbreak psychological risk factors, the effects of stigma and discrimination or impact on families is lacking. of note, it was difficult to compare studies due to heterogeneity of design and outcome measures. geographic factors may have influenced results due to unique social and cultural contexts amongst the study locations where research was conducted. from this review of hcws, fear of uncertainty or becoming infected in the course of their work were at the forefront of the psychological challenges faced. providing medical care during a global epidemic generates fear and heightens stress levels, with one large-scale study reporting over % identified that becoming infected was most distressing. during the covid- pandemic, hcws have been exposed to high infection risk, death and dying, moral dilemma in deciding who qualifies for intensive care, and excessive workloads. the entire experience can be traumatising and heighten the risk of mental health conditions in a group that are already at increased risk, for instance hcws are at higher risk of suicide than the general population. it is likely that the psychological effects of epidemics on hcws are variable across different contexts with several studies demonstrating an increased risk of acquiring a trauma or stress-j o u r n a l p r e -p r o o f related disorder. the risk to the mental well-being of hcws are likely to be multi-faceted and more research is needed to elucidate the underlying mechanisms that can potentially be mitigated with appropriate measures. collection of high quality data is urgently needed, especially for vulnerable groups exposed to a pandemic. interventions to reduce morbidity and severity of psychological problems in hcws in the early stage may prevent adverse short-term and long-term implications. it is important to note that professional recognition and ethics can positively reinforce hard work but the value of these are diminished when they are applied in a punitive way that stereotypes hcws. the emphasis on their self-sacrifice while providing essential and 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severe acute respiratory syndrome suicide among physicians and health-care workers: a systematic review and meta-analysis multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science. the lancet psychiatry uk military doctors; stigma, mental health and help-seeking: a comparative cohort study first responders and psychological first aid resilience scale- . dsm-iv=diagnostic and statistical manual of mental disorders ghq- = general health questionnaire mers=middle east respiratory syndrome mspss=multidimensional scale of perceived social support primary care ptsd screen for dsm- . phq- = patient health questionnaire- . phq- =patient health questionnaire- . phq- =patient health questionnaire. phq- = patient health questionnaire- scid=structured clinical interview for dsm-iv. scl- -r=symptom checklist- -revised. scl- = symptom checklist- . sds=zung self-rating depression scale sf- = medical outcomes study short form survey ☐ the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.☒the authors declare the following financial interests/personal relationships which may be considered as potential competing interests:the corresponding author is not a recipient of a scholarship. there is no funding associated to this study. sonja cabarkapa, sarah nadjidai and jerome murgier have no conflicts of interest. chee ng declares receiving the following over the last months; travel support and honorarium for delivery of talk from both lundbeck and pfizer. he has also received travel support and honorarium for consulting service for janssen. key: cord- -ax i d f authors: karampourian, arezou; ghomian, zohreh; khorasani-zavareh, davoud title: exploring challenges of health system preparedness for communicable diseases in arbaeen mass gathering: a qualitative study date: - - journal: f res doi: . /f research. . sha: doc_id: cord_uid: ax i d f background: infectious diseases are common problems in mass gatherings, especially when there is a lack of health system preparedness. since iran is one of the most important countries on the walking path of arbaeen and has a vital role in providing health services to pilgrims, the experiences of health challenges by participants is of key importance. the aim of this study is to explore stakeholders’ experiences on the health system's preparedness and challenges, and to provide suggestions for preventing infectious diseases during the arbaeen mass gathering. methods: a qualitative research method was used with a conventional content analysis approach. the number of participants was , including executive managers and health policymakers who entered the study among participants. semi-structured interviews were used to generate the data. interviews were analyzed by means of content analysis after face-to-face interviews. results: data analysis resulted in the extraction of four main themes and sub-themes. health infrastructure defects in iraq has three sub-themes (health abandonment in iraq, the weaknesses in health culture and problems related to the health system); poor control of the causative factors of infectious diseases has three sub-themes (the underlying factors of the prevalence of contagious diseases, health system response to communicable diseases and ignoring the risks of the arbaeen ceremony); the low perception of risk in pilgrims has three sub-themes (lack of awareness in pilgrims, fatalism in pilgrims and unhygienic belief in pilgrims); and the ineffectiveness of health education has two sub-themes (training shortage in the targeted group and educational content problems) that shows participant’s experiences of the health system's challenges for coping with infectious diseases during the arbaeen ceremony. conclusion: pilgrim-based training, planning and controlling other challenges may change these threats to opportunities and improve the health of participants of the mass gathering of arbaeen in the region. according to the definition of the world health organization (who), any structured or spontaneous event leading to a certain number of people gathering in a particular site, for a specific aim in a determined period, putting pressure on the response resources and social programs, is called a mass gathering. mass gatherings are divided into different types based on their purpose. the expansion of interconnectivity between societies and increases in the number of national and international events in communities has led to an increase in the number of mass gatherings, which, despite the benefits like cultural exchange, have health challenges such as infectious disease transmission and, should therefore be considered by health planners . one of the health challenges of mass gatherings is the prevalence of infectious diseases and the outbreak of diseases, which, along with, complicated health needs of participants increases the health burden on the host country. the public health system can be under severe pressure, even with advanced equipment and the proper resources for prevention and control of infectious diseases - . various factors, such as the type and location of gathering, the number of participants and the lack of access to health facilities, can affect the incidence of infectious diseases in mass gatherings. planners must therefore pay attention to these factors in preparation , [ ] [ ] [ ] . since a mass gathering is a collection of many people together in one particular site, the possibility of infectious disease transmission due to the high population density always exists. studies on mass gatherings such as hajj, ashura day in karbala, and kumbh mela and sabarimala in india show the prevalence of infectious diseases in these ceremonies [ ] [ ] [ ] [ ] [ ] [ ] . the dates of religious ceremonies like hajj and arbaeen are decided using the lunar calendar (the islamic or hijri calendar) which is not only shorter than the gregorian calendar, meaning that these events occur days earlier each year and can synchronize with different seasons and season-associated diseases. accordingly, planners and policy makers of public health are faced with changing goals, requiring health system preparedness , . one of the world's largest religious gatherings is the arbaeen ceremony, which happens on the th day after the anniversary of imam hussein's martyrdom, the third shiite imam. in the ashura event, pilgrims walk to karbala, south of baghdad. based on the statistics of , the number of iranian pilgrims taking part in the arbaeen ceremony was , , . iran is a neighboring country of iraq and shares a common land border with it. pilgrims from other neighboring countries of iran, such as afghanistan and pakistan, cross iran to reach iraq and the arbaeen ceremony. on the basis of the mutual memorandum of cooperation between the two countries of iran and iraq, iran is committed to providing health services to other pilgrims in addition to iranian pilgrims . therefore, it is necessary to have a plan for preparedness in dealing with infectious diseases during arbaeen ceremony. if a mass gathering is not carefully managed, it can lead to the distribution of infectious diseases. in mass gatherings, infectious diseases are threats to global health security and even the political security of countries. therefore, planning, communication and public health supervision are important in these religious ceremonies , . mass gatherings are different from structured disasters so that in case of occurrence, many people will be affected . since the arbaeen ceremony is held with the presence of many pilgrims from many different countries and, like the hajj pilgrimage, is based on the lunar calendar, and it is held in iraq, there is the possibility of the occurrence and transmission of infectious diseases. it is therefore essential to be prepared to control and prevent these diseases. dealing with infectious diseases in arbaeen is considered a challenge for policy makers . according to arbaeen's social and cultural context, it seems essential to take a deeper look in this field. on the other hand, there is relatively little knowledge about the arbaeen ceremony; therefore, a qualitative method for clarifying the concept and challenges of health system preparedness in arbaeen ceremony is necessary. the aim of this study was to explore challenges of health system preparedness for communicable diseases in arbaeen ceremony. we collected data from june to march . since the study attempted to explore preparedness challenges of health systems, a qualitative research method with the approach of conventional content analysis was used . the health system's challenge in arbaeen is multidimensional, owing to the cultural difference between iran and iraq, the challenges faced by the health system during the arbaeen pilgrimage should be investigated in both countries. indeed, the cultural practices of the participants, especially those surrounding health, differs during the arbaeen ceremony. therefore, a qualitative research method, with the aim of describing phenomena, providing new knowledge, insight and a practical health guide, is the method used in this study , . the study was conducted using in-depth interviews, based on stakeholder's experiences in iraq-iran land terminals (mehran, shalamche, and chazaba) and also in health care posts in iraq. the interviews were conducted with health care providers and policy makers, as well as pilgrims in the arbaeen ceremony. participants were chosen among executive managers and policymakers of the ministry of health and medical education, medical training and treatment and other related organizations, including the red crescent organization, mobilizing the medical society, the hajj and pilgrimage organization, medical universities in the border cities and the social security organization. in total, participants, consisting of executive managers and health policymakers, were selected in this study through purposeful sampling with the aim of exploring challenges of health system preparedness for communicable diseases in the arbaeen ceremony. the existence of practical experience in planning or participate in arbaeen ceremony and the ability to communicate and willingness to participate were inclusion criteria in the research. we recruited participants either by phone call or by approaching them in person. "maximum variety sampling" was used to explore the experiences of the participants in those selected so that they were chosen from the ministry of health and medical education, medical training and treatment and other related organizations, including the red crescent organization, mobilizing the medical society, the hajj and pilgrimage organization, medical universities in the border cities and the social security organization, with different experiences of work, education and gender. inclusion criteria included the existence of practical experience in planning or participate in arbaeen ceremony, the ability to communicate and willingness to participate in the research (table ). the study was done through face-to-face interviews followed by telephone interviews for concept saturation. the data was collected using audio recorders with permission from the participants. ak conducted the interviews, ak and dkz transcribed the data. ak and dkz and zgh coded the data. dkz and zgh performed rigor. initially the first two interviews were conducted in a non-structured format, with the following interviews being semi-structured. open questions used to generate the data were developed by experienced and/or knowledgeable policy makers and health care providers. the individual's experiences and beliefs were used without considering their specialty . interviews were continued until data and concept saturation were reached . the interview duration was between and minutes, based on the tolerance, amount of information and desire of the participants. interviews were performed individually and based on participants' willingness in terms of time and site. firstly, interview questions began with the following general questions based on the participants' level and the main questions of the research: "how was your organization preparedness plan to deal with infectious diseases in arbaeen ceremony?"; "please express your experiences of related challenges in infectious diseases in arbaeen ceremony"; "what problems were in your preparedness plan?"; "what problems did you face in the vaccination program of the health team and pilgrims in arbaeen ceremony?"; and "what is your offer to pilgrims for a safe pilgrimage?" following this, exploratory questions were gradually used to clarify the concept and deepen the interview process: e.g. "please explain further what you mean?" and "why?" at first, the interviews were transcribed verbatim and then typed up using microsoft word office. the data were analyzed through a conventional content analysis method . first, the main researcher converted the interviews to written texts. the digital files were listened to several times and the texts were read repeatedly. next, the meaning units were determined based on the aim and the question of the research. meaning units were a collection of words and sentences that were related to each other in terms of content and were grouped together. meaning units reached the level of abstraction and conceptualization and were coded considering the research question. the key points and subjects were extracted as open codes. these codes have been put under the broader headings based on the present similarities and differences; in other words, the data were reduced in order to describe the phenomenon and gain a better understanding, and this abstraction process continued until concept extraction . data first emerged as meaning units, then condensed meaning units, codes, sub-themes and finally themes. the study was approved by ethics committee of shahid beheshti university of medical sciences on / / , no. ir.sbmu. retech.rec. . . the interviews were conducted and recorded with participants' consent. written or verbal consent was taken from participants to participate in the study. verbal consent was only taken for telephone interviews; this was due to the distance between interviewer and interviewee. anonymity, confidentiality and the right of resignation were informed to participants and considered during the study. the interview time was set according to participants' willingness. the researchers used the trustworthiness criteria recommended by guba and lincoln to establish rigor . all authors were engaged in the environment and field of research. in addition, the principle investigator always had suitable involvement with the participants for in-depth interviews. credibility was established by the prolonged engagement of researchers with participants. researcher triangulation was also used to verify the accuracy of the coding process. the research team also retained raw data, codes, and themes for control of the reliability. at the same time, sampling was carried out with maximum diversity in order to provide triangulation by means of credibility and confirmability. a detailed description of the method was used to establish transferability. engaging participants in the research increases the interaction between researchers and participants and then the credibility . the research supervisor monitored the data collection and data analysis process. it is necessary to mention that the research team participated in the arbaeen ceremony as pilgrim and conducted field notes. also, memberand peer-checking were used to ensure credibility. therefore, many interviews with related topics were sent to some external expert reviewers and participants (policymakers of the ministry of health and medical education, medical training and treatment and the red crescent organization) to be checked, and they were requested to assess the degree of relevance between the findings and raw data. moreover, transferability was established by sampling with maximum variation from various centers, including the ministry of health and medical education and other peer organizations including the red cross organization, the medical community mobilization, the hajj and pilgrimage organization, the country's medical universities in the border cities and the social security organization with different experiences of work, education and gender. a completed srqr checklist is available in supplementary file . themes and sub-themes the mean age of participants was and the mean time of work experience was years (table ) . overall, original codes were extracted and after integration using conventional concept analysis, four original themes consisting of sub-themes were identified. the theme of "health infrastructure defection in iraq" had three sub-themes: "health abandonment in iraq", "the weakness of health culture" and "problems related to health system". the theme of "poor control of factors effective in infectious diseases" had three sub-themes: the "underlying factors in prevalence of contagious diseases", "health system response to communicable diseases" and "ignoring the risks of the arbaeen ceremony". the theme of "low perception of risk in pilgrims" had three sub-themes: "lack of awareness in pilgrims", "fatalism in pilgrims" and "unhygienic belief in pilgrims". the theme of "ineffectiveness of health education" had two sub-themes: "training shortage in the targeted group" and "educational content problems" (table ) . according to the findings of this study, the main theme is pilgrim-based education. it seems that the biggest issue with the prevention of communicable diseases in the arbaeen ceremony is pilgrim-based education. educating pilgrims can directly help people to create or reform health infrastructures in iraq. education can also help to identify health risks and respond to them by identifying effective factors in combating infectious diseases. the training of health instructors and guidelines from people who are trusted and accepted by pilgrims, such as missionaries and religious leaders, can have a positive impact on their beliefs. the main point of training is to determine the targeted group both at the level of pilgrims and health directors and consider the training needs of each group in preparing training guidelines. health abandonment in iraq. most of the participants believed that the iraqi health system has been abandoned because foodstuff distribution is not under the supervision of a special organization and does not have a special trustee in the execution and monitoring of health rules or, if there is one, he is inconspicuous. the existence of a trustee or supervisor in the health system can prevent the delivery and distribution of unsafe food and reduce the prevalence of infectious diseases. unhealthy foodstuff preparation, production and distribution, and a lack of food evaluation and supervision system can lead to gastroenteric disease. based on the participants' experiences, the lack of a health system trustee means system weakness. the following quotation is an example of the above: "sometimes donations are prepared in an unhealthy manner and so lead to acute digestive problems… the health system is weak in iraq because health rules are not enforced and there is no supervision for these centers…" (executive manager, male, - years, - years job experience). the weakness of health culture. according to the participants' point of views, observation of unhealthy behaviors, such as neglect of the individual and public health standards, and the existence of cultural differences between iran and iraq, are considered by pilgrims to bring about an unsafe culture. policy makers and executives should be familiar with the kind of health culture in iraq so that they can develop a program to prevent contagious diseases. in iranian culture, the non-use of spoons and forks is considered as lack of health belief and neglect of health, whereas in iraq, eating food with the hands is part of the food culture. iran's health system can help train the iraqi people in sanitary practices alongside iranian pilgrims. the following quotation is an example of the above: "some food providers don't meet health … the culture of using spoons and forks for food serving is different in iran and iraq… one of the cultural works which we can do in iraq is health education…" (executive manager, male, - years, - years job experience). problems related to health system. most participants acknowledged that despite annual health care improvements in iraq, there are also some shortages in this field due to the lack of a long history of a health service system. health system weakness, incomplete health service implementation and insufficient supervision of environment health are indicative of the weakness of the health infrastructure; this has made it impossible to provide environmental health, sanitation and waste disposal. the following quotation is an example of the above: "health background in iraq was poor… there were no waste bins and waste sanitation there… failure to implement health services has led to failure in meeting health conditions … there was no health the probability of an outbreak of endemic and non-native diseases the ineffectiveness of the health system in screening the impossibility of requirement flu vaccination the inability of the system to provide services in an epidemic the underlying factors in prevalence of contagious diseases. most participants have identified underlying factors of infectious diseases as one of the challenges affecting the preparedness of the health system in dealing with infectious diseases. various factors, such as population density and diversity, not paying attention to the principles of personal and general health, for example through a lack of health facilities, weather conditions during the trip and changes in nutrition can cause the spread of infectious diseases. identifying these factors helps pilgrims and planners to prevent infectious diseases. the following quotation is an example of the above: "there were few toilets or no healthy facilities. somehow, pilgrims would have to sleep in the desert or in a limited space with a lot of people… congestion of pilgrims from different countries increases the risk of spreading infectious diseases…" (executive manager, male, - years, over year job experience). health system response to communicable diseases. on the basis of the view of participants, mass population movements from different countries and their gathering with different population diversity can transfer and spread endemic diseases and also emerging diseases such as plague and anthrax. there is also the possibility of bioterrorism events occurring during the arbaeen ceremony. the health system needs facilities such as equipped laboratories to diagnose and treat infectious diseases in a timely manner. the inaccessibility or lack of experimental equipment for disease identification leads to the failure of timely diagnosis of diseases, a lack of disease control and finally the incidence of epidemics. syndromic surveillance system can be used to diagnose infectious diseases. there is a need to correctly pass the treatment period of infectious diseases in order to prevent epidemics, although drug shortages can affect treatment completion and is one of the causes of epidemics. vaccination also helps to prevent infectious diseases, but the requirement of pilgrims to vaccinate is always up to the host country and since vaccination is not one of iraq's priorities, the ministry of health and medical education can only advise pilgrims to vaccinate. the following quotation is an example of the above: "there is the probability of spread of local and new-appeared diseases and even bioterrorism due to the gathering of pilgrims from different countries… some diseases can't be diagnosed due to lack of facilities but syndromic surveillance system can be used. …the large number of pilgrims and lack of medication have led to not having complete course of antibiotic treatment… the need for vaccination is one of the requirements of the host country". (policy makers, male, - years, - years job experience). the arbaeen pilgrimage has special features that distinguish it from other mass gatherings. participation of different peoples with a diverse range of socio-demographic statuses, cultures and nationalities makes this distinction. the arbaeen pilgrimage has some specific hazards like other trips that are sometimes neglected. the population of arbaeen pilgrims and its time of year are changeable. financial management of travel expenses at the ceremony is carried out by volunteers. considering these features is essential for the readiness program. in the opinion of the majority of participants, one of the challenges of the health system is the lack of attention to the risks of arbaeen ceremony and the lack of planning based on these features. the following quotation is an example of the above: "arbaeen is a new phenomenon that children and adults, men and women with different cultures and ethnicities take part in the ceremony … even with the knowledge of the dangers of the route, people attend arbaeen ceremony… arbaeen is a spontaneous and popular event and doesn't cost much … the population is moving and the time of the ceremony changes every year …" (executive manager, male, - years, - years job experience). lack of awareness in pilgrims. one of the challenges in the view of the participants, especially executives, is the pilgrims' low awareness of health hazards, such as not using personal hygiene products and non-compliance with health standards. unhealthy and dangerous practices, such as unsanitary food consumption, are not understood by pilgrims, and this low awareness and inadequate knowledge of the risks are the causes of infectious diseases in the pilgrims. respect for personal and public health, such as hand washing, providing food from health food centers and avoiding overeating, is effective in preventing digestive diseases. the following quotation is an example of the above: "some pilgrims do not wash their hands or do not use personal hygiene products …or they do not get foods from healthy centers … overeating and then digestive problems are one of the pilgrims' problems … the other problem is not being familiar with arabic language …" (executive manager, female, - years, less than years job experience). participants believed that one of the health challenges is belief in destiny and fatalism; so that most pilgrims who participate in the arbaeen walking ceremony, based on their belief in destiny, have a relatively low understanding of the dangers and diseases, and begin their trip merely confident in allah and without any plan for dealing with infectious diseases, such as vaccination, and continue the way using food and drinks that are often unhealthy. the following quotation is an example of the above: "it's enough to decide to travel and you do not need to have a special plan … if you think openly, you won't get sick, and nothing bad will happen…" (policy makers, male, - years, - year job experience). based on the participants' experiences, low perception of danger in pilgrims is sometimes seen as insanitary beliefs in preventing medication consumption and disregarding hygiene recommendations. believing in the use of medication during illness, preventing self-curing and trying to abide by hygiene recommendations prevents infectious diseases. the following quotation is an example of the above: "sometimes we see pilgrims using traditional treatments instead of antibiotics consumption… they don't pay attention to hygiene recommendations such as masking and not using suspicious food…" (executive manager, male, - years, - year job experience). training shortage in the targeted group. based on stakeholders' views, one of the present challenges is the quantitative and qualitative shortage in the stakeholder's training level. this means that providing a personal and public health plan should cover all stakeholders, including executives, policymakers and volunteers in the arbaeen ceremony, and be considered with respect to each participant. furthermore, the timing of training is also important and should be before the days of arbaeen ceremony in order to have a greater effect on the individuals' knowledge. indeed, training courses should be held separately for each of the groups, pilgrims, executive managers, and policymakers, and at a proper time before arbaeen. the following quotation is an example of the above: "training should not exactly be in the days of arbaeen. personal and public health training must be held several months before arbaeen… the training is not only for pilgrims, but also anyone involved in arbaeen ceremony. everyone should be trained from pilgrims to policymakers…" (policy maker, male, - years, - year job experience). another problem was the provision of educational content. most of the participants believed that training should be fitted with pilgrims' needs and respond to the problems of pilgrims. pilgrims should be divided into different groups based on the level of education, their problems and illnesses, and individual and general education should be planned accordingly. participants also believed that training in the area of personal, general and nutritional health should be provided more comprehensively. the following quotation is an example of the above: "we should divide pilgrims to diverse groups and send targeted training messages to each group, not the same training for everyone… the benefactors should be trained…pilgrims should have more training…" (policy maker, male, - years, - year job experience). the aim of this study was to explore the challenges of health system preparedness for infectious diseases in the arbaeen ceremony as the first qualitative study in iran. the most important findings of the study are the ineffectiveness of health training, the low perception of risk in pilgrims, poor control of the causative factors of infectious diseases, and deficient and defective health infrastructure in iraq. based on the views of the majority of participants, pilgrim-based training is the most effective factor in health system readiness in dealing with infectious diseases in the arbaeen ceremony. ineffectiveness of health training is one of the challenges of health system preparedness. one of the plans which should be considered to ensure arbaeen ceremony preparedness is health training. educational planning must be done before holding the arbaeen ceremony, with consideration of the training content and targeted groups. indeed, according to the needs of the targeted group, training must be given to pilgrims, executives and volunteer treatment teams, and the training content for pilgrims should be different to that of executives and policy makers. past conducted studies of religious gatherings such as the hajj in saudi arabia and ashura day in iraq, as well as other mass gatherings, such as the tamworth country music festival, australia, indicate the reality that a crowd of people from diverse nations and cultures is a source of infectious disease; disease transmission is one of the most important challenges of public health in these kinds of events, so using training strategies in relation to hand washing, masking and vaccination is an important factor in preventing the diseases and health improvement , , , - . since religious ceremonies are rooted in people's beliefs and have great popularity among people, people-centered education therefore has great potential to reduce the gap between knowledge and practice in pilgrims, empowering individuals and enhancing their ability to deal with health threats. this goal is achieved by identifying accurate and targeted needs, developing relevant content and through educational planning . in this study, like other studies on mass gatherings, a personal health training plan, such as the importance of hand washing, using healthy food and masking, should be included in the pilgrims' training plan, and public health training such as vaccination, environmental health, monitoring donations, cooking and distribution, controlling bioterrorism and establishing mobile toilets should be considered in executives and policymakers' preparedness plan. regarding the aim of holding the arbaeen ceremony, which is a popular religious-ideological ceremony, training can be performed in mosques before the ceremony by clergy. a low understanding of the risks of infectious diseases in pilgrims is one of the other challenges mentioned by the majority of participants, especially policymakers. a lack of risk understanding refers to the inability to identify and respond to dangerous situations. top documents such as sendai framework have identified that understanding risks is the first priority to decrease the incidence of disasters, and that it needs people-based and vast preventive approaches. besides this, the hyogo framework and sustainable development goals emphasize the role of training in increasing risk understanding and decreasing the vulnerability of individuals to hazards - . in this study, one of the health issues was fatalism and a low understanding of risk. a study concerning the beliefs and methods of infection control in hajj pilgrims residing in australia also showed that the majority of participants had low understanding of the occurrence of respiratory infections and the need for an influenza vaccine in hajj, and refused the vaccine, using trust in allah as an excuse and belief in destiny when dealing with the risk of disease . another problem is also the prevalence of self-treatment among pilgrims. in a study aimed at assessing the knowledge, attitude and the performance of australian pilgrims on using antibiotics in hajj showed that they did not have proper understanding of using these drugs and used medications arbitrarily, meaning that more training on proper use is needed . a lack of understanding of health instructions and disregard for public and personal health in any situation can endanger human health. it seems that the fatalism of pilgrims with regards to diseases increases their vulnerability if the understanding of danger is reduced. islamic instructions state that the person is obliged to preserve his health and life in any location and position, even in holy lands, and to avoid risks . given that arbaeen is a religious gathering, religious leaders have an important position in ceremony implementation and can affect the pilgrims' beliefs and understanding of risks during pilgrimage. the influence of religious leaders on the people's beliefs can provide the opportunity to promote health. we should consider that religious scholars must be trained first and then transfer health instructions and methods of infectious disease control to the people in cultural and religious gatherings such as mosques. another problem in this field is the poor control of the effective factors on infectious diseases. one of the most common causes of infectious disease is the epidemiology triangle, which has three components-pathogen, host and environment. the interaction of these agents causes infectious diseases, and considering these factors can help control infectious diseases . considering the three factors in arbaeen is very important. the 'host' factor includes different pilgrims with diverse cultures and nationalities. the 'environment' factor includes holding the ceremony in iraq, which, due to the many years of internal and external conflicts, has had little attention paid to its health infrastructure, and also the overall environmental factors effective in the occurrence of infectious diseases. different studies , , have shown that factors such as crowd size, equipment, climate, the event duration and location, the type of ceremony, and features and behavior of participants affect the occurrence of diseases in mass gatherings, and planners must consider it during preparations. to prevent the occurrence of contagious diseases and their consequences, comprehensive planning, rapid diagnosis and effective management is required , , . one of the factors that affects the occurrence of disease is the time of year that the arbaeen ceremony is held. arbaeen ceremony is held based on the lunar calendar and so its needs and challenges differ and are dependent on the season that the ceremony is held, so that if the ceremony is held in cold seasons, respiratory diseases are more common and if is held in hot seasons, the majority of infectious diseases are of the digestive system. additionally, population movement among different countries leads to the transfer of local diseases, so health considerations and cooperation between states are needed.. policymakers should consider three components-pathogen, host and environment-before the beginning of arbaeen mass gathering. it is also necessary that the health system is aware of all possible scenarios and the methods for dealing with them. the preparedness plan at the local level includes assessing the risk, resources capacity, equipment, surveillance system and an expert team for providing services to pilgrims. health infrastructure defects in iraq was another challenge to the health system from the participants' perspective. the term 'health infrastructures' refers to health facilities and their related factors. the infrastructure includes staff instructions, processes and the development of systematic approaches related to personnel resources and medical support plans . various studies indicate that readiness for structured mass gatherings depends on investing in health infrastructures and the size of gatherings, and strengthening infrastructures and post-event coordination of mass gatherings must be continued. the inappropriate location of gatherings, the weakness of facilities and the lack of infrastructure increase the vulnerability of communities , . the remoteness of health facilities and a lack of needed road infrastructure can make medical services and emergency assistance ineffective. limitation of infrastructure and medical care system, increase the incidence of injuries , . arbaeen is held in a country that has long been involved with interior and exterior wars; therefore, it seems that due to economic difficulties, it does not have the capacity to support the necessary health infrastructure required by pilgrims. although according to the participants, the health system in iraq seems somewhat weak, given that arbaeen ceremony is of particular popularity among shia muslims and is held annually, therefore, some of the activities serving pilgrims and its management during the arbaeen ceremony is voluntarily conducted. in recent years, numerous health facilities have been constructed on religious places, as well as along the path of pilgrimage using pilgrims' donations. management of pilgrims' donations can help to build and maintain health infrastructure in iraq. with this policy, the iranian pilgrims will benefit from the arbaeen ceremony, and the level of health in the region will be improved. this study is the first qualitative study on the experiences of arbaeen, so it provides rich information in this regard; however, since the results have been collected from semi-structured interviews, it is considered subjective. it is recommended that in future studies, by creating a quantitative instrument for examining the challenges and measuring, the subjective concepts can be objectively transformed and analyzed. the present study can be used as a basis for this purpose. the ineffectiveness of health training, low perception of risk in pilgrims, poor control of the effective factors on infectious diseases and deficient health infrastructure in iraq are important challenges of the health system in dealing with contagious diseases in the arbaeen ceremony from the stakeholder's perspective. therefore, pilgrim-based educational planning, along with the control of other challenges, represents an opportunity to improve the health of pilgrims taking part in the arbaeen ceremony. the full data for this study are not provided because the transcripts of the interviews contain identifiable and sensitive information. researchers can apply to access limited deidentified transcripts of interviews from the first author, arezou karampourian (a.karampourian@sbmu.ac.ir) under no strict conditions. please note that transcripts are only available in persian. the study was supported by the shahid beheshti university of medical sciences, tehran, iran. . . the paper is interesting and adds to the medical literature of arbaeen ceremony which has been poorly addressed from a public health research perspective. we hope this paper will serve as a key reference on health aspect of arbaeen ceremony in near future. a few minor issues should be addressed before the manuscript is published. the reference list needs to be revised, we note some misplacement error. for example, in the third paragraph of the introduction (p ), "based on the statistics of , the number of iranian pilgrims taking part in the arbaeen ceremony was , , ", the reference given for this is number . ineffectiveness of health education. emerging of all four themes has been verified by the participants' comments which made results acceptable. the method of analysis is appropriately explained which can facilitate the reproducibility. the authors conclude that the main factor in preventing communicable disease is pilgrim-based training long before the ceremony. this conclusion is adequately supported by the results. is the study design appropriate and is the work technically sound? yes are all the source data underlying the results available to ensure full reproducibility? yes no competing interests were disclosed. i have read this submission. i believe that i have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. the benefits of publishing with f research: your article is published within days, with no editorial bias you can publish traditional articles, null/negative results, case reports, data notes and more the peer review process is transparent and collaborative your article is indexed in pubmed after passing peer review dedicated customer support at every stage for pre-submission enquiries, contact research@f .com establishment of public health security in saudi arabia for the hajj in response to pandemic influenza a h n knowledge, attitude and practice (kap) survey concerning antimicrobial use among australian hajj pilgrims fatalism at the arbaeen ceremony methodology of applied research in medical sciences letter to editor: mortality trends of pilgrims in hajj: an implication for establishment of surveillance system. health in emergencies and disasters qurterly should cities hosting mass gatherings invest in public health surveillance and planning? reflections from a decade of mass gatherings in pubmed abstract | publisher full text | free full text human stampedes during religious festivals: a comparative review of mass gathering emergencies in india pattern of morbidity and mortality in karbala hospitals during ashura mass this study is part of a phd thesis. the authors thank shahid beheshti university of medical sciences for approving the study, as well as all participants in this study who participated in the study, despite being busy. click here to access the data. competing interests: we have read this submission. we believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. it is better to discuss the results respectively as the results mentioned. so, the reader can insure . it is better to discuss the results respectively as the results mentioned. so, the reader can insure that all results have considered in the discussion part. it is better to explain what pilgrim-based education is and how it controls cd in discussion part and conclusion as well. are all the source data underlying the results available to ensure full reproducibility?no source data required no competing interests were disclosed. this is an interesting and well-written piece of work. infectious disease prevention strategies in mass gatherings, especially religious or cultural gathering, need to start with such the qualitative study. having a predetermined program, implementation, evaluation, and upgrade of the strategies in preventing and responding to communicable diseases requires the proper recognition of the contextual factors and challenges, experiences and perception of healthcare providers and decision-makers of the key agencies involved. the authors carried out a qualitative study with conventional content analysis approach about the arbaeen ceremony, a religious mass gathering in iran and iraq and found four main themes: -health infrastructure defects in iraq, poor control of the causative factors of infectious diseases, -the low perception of risk in pilgrims, and ineffectiveness of health education. emerging of all four themes has been verified by the participants' key: cord- -ls vud authors: khan, farah; eskander, noha; limbana, therese; salman, zainab; siddiqui, parveez a; hussaini, syed title: refugee and migrant children’s mental healthcare: serving the voiceless, invisible, and the vulnerable global citizens date: - - journal: cureus doi: . /cureus. sha: doc_id: cord_uid: ls vud millions of children are on the run worldwide, with many unaccompanied children and adolescents undertaking risky journeys to flee war, adverse circumstances, and political persecution. the grueling journey and multiple stressors faced by the refugee children, both accompanied and unaccompanied during the pre-migration, migration, and in the country of destination, increase their risk for psychiatric disorders and other medical conditions. unaccompanied refugee migrant children have higher prevalence of mental health disorders than accompanied refugee peers. long after reaching the host country, the refugee, migrant, and asylum-seeking juveniles continue to face adversities in the form of acculturation. in assessing medical fitness and healthcare mediations for refugees and migrant children, special consideration should be given to certain areas such as their distinct history, whether they are with their family or separated or unaccompanied, and whether they have been peddled or have been left behind. an alarming number of children travel with family or alone without proper care to flee organized violence, war, and persecution in their native country. some cross their national borders to become refugees and seek asylum in other countries, a legal process recognized by the united nations. without a family or an adult, these children are often at risk of being exploited and abused. most of the refugee children live in nearby countries close to their own native place of origin that happen to be low-or middle-income countries [ ]. in , in italy about % of children arriving by sea were separated and unaccompanied [ ] . in , the high-income countries resettled , refugees [ ] . in , juveniles under years of age incorporated about half of the refugee population [ ] . in , uganda recorded , child refugees, the largest number of unaccompanied and separated child refugees with the overwhelming majority aged under and a couple thousand aged under . from - , turkey has been hosting . million refugees, the largest refugee population [ ] . in , the most common country of origin among child asylum seekers happens to be syrian arab republic. in , germany registered % of all child asylum applications lodged in europe ( , children), while the highest number of first-time applicants with regard to its population was greece [ ] . the grueling journey faced by the refugee children, both accompanied and unaccompanied during the pre-migration, migration, and in the country of destination, is associated with multiple stressors resulting in elevated risks for psychiatric disorders and other medical conditions [ ] . the clinicians should be aware that exposure to war, a long arduous journey with minimum or no care, and ongoing stressors that refugee kids have experienced are associated with physical, developmental, and mental health problems. this migration is in itself dangerous, and apart from mental and other health costs to it there is also an increased risk of disabilities, and vulnerabilities to acute and chronic ailments. this article discusses some of the commonly seen mental health conditions and other medical conditions in refugee and migrant children from the reviewed articles. it also provides an insight into the refugee mental health struggles during the coronavirus (covid- ) pandemic and the migrant detention facilities. studies were selected and reviewed after applying the inclusion/exclusion criteria on pubmed. the following were the inclusion criteria: ( ) age years and younger, ( ) both female and male, ( ) articles in english, and ( ) studies published within the last one year. exclusion criteria were age above years and non-english articles. the articles selected from pubmed were broken down as seen in table . after applying inclusion/exclusion criteria and using regular keywords, the total number of articles selected after review and refined search were as they fit the selection criteria. the articles removed were not included for lack of relevant data. the flowchart seen in figure shows the starting keywords used, and the number of articles obtained on pubmed for literature search with the applied filters. finally, the total number of used articles is displayed alongside those which were not selected. barriers, economic opportunities, lack of understanding of the healthcare system, knowledge about available resources, issues pertaining to accessing health and other services, trust factor, financial problems, transportation issues, and the larger policy and political context of local authorities [ , ] . primary care physicians, pediatricians, and mental health providers can build trust through culturally competent and trauma-informed care, assess for healthcare needs, provide vaccination update and preventative care, and screen for mental health, communicable diseases, disabilities, and other medical health conditions thereby attending to the holistic needs of the vulnerable child and adolescent refugees. refugee children are less likely to avail pertinent health and social care than non-refugee children peers [ ] . most host countries offer some kind of health screening for refugees, both child and adult, upon entering the country of destination [ ] . in assessing medical fitness and healthcare mediations for refugees and migrant children, special consideration should be given to certain areas such as their distinct history, whether they have migrated along with their family or have been separated from family, are unaccompanied, whether they have been peddled, or have been left behind [ ] . children's right to medical care is guaranteed by all the world leaders and member states of the who european region and is compiled in the convention on the rights of the child (crc), a convention guaranteeing the highest attainable standard of healthcare and treatment of illness and rehabilitation of the refugee, migrant, and asylum-seeking children similar to the children native to the host country [ ] . the most vulnerable children include the asylum seekers and the undocumented or unregistered migrants. asylum seekers have usually been tested with war and/or political oppression in their native country and live in uncertainty and temporary circumstances regarding their future. the undocumented children often live in dangerous environments with little or no availability of basic societal rights, in abuse, poverty, brutality, and social boycott, and among threats of deportation [ ] . migrants face a myriad of issues during various aspects of their journey between countries. during the pre-migration phase of this process, there is a lack of access to health/dental care, scarcity of food, and exposure to diseases. during the journey, lack of access to health/dental care and food scarcity continue to be problems. additionally, human trafficking, violence, and injuries during the trip are also present. finally, in the country of destination, difficulty in finding resources presents itself as the largest barrier. these resources include health/dental care, education, therapy, and other basic amenities. this process repeats itself and becomes a cycle if migrants are deported back to their country of origin and seek to migrate once again [ ] . refugees and migrants arriving in the host country, many of which have different cultures and languages from their native country, go through a course of learning and acclimatization to the new civilization. this stressful process of acculturation compounds the migration strain thereby amplifying the psychological distress. children and adolescents, who are enrolled in school, generally learn the new host country language faster and conform to the new culture faster than parents, who may be secluded giving rise to new challenging family issues. family tensions can cause disharmony, separation, and even assault, with associated adverse effects on a child's mental health [ ] . some of the needs of the refugees and migrants include access to mental health services; the youths have a need for civil activities and community acceptance while the parental urgency is to feel culturally protected. competency in a local language of the host country, and support from local community, school, and local authorities make their transitions easier and decrease the acculturation stress. figure shows some of the mental and other health challenges of the refugee and migrant children. communicable diseases: cramped and overpopulated settlement and lack of cleanliness and sanitation in facilities housing refugee and migrant children put them at increased risk for diarrhea and skin infections [ ] . the third-world countries show a higher prevalence of tuberculosis, malaria, intestinal parasites, and hepatitis b and c, than the developed nations. these chronic infections are present in increased prevalence in refugee and migrant juveniles [ , ] . a study reports of unaccompanied refugee and migrant children who were arriving in germany with multidrug-resistant bacteria colonization at higher rates, and other records of a surge of measles, which is vaccine-preventable, have also been seen in asylum-seeking juveniles [ , ] . clinicians should have a low threshold to screen for sexually transmitted infections (stis) in adolescent refugees as they have the highest rate of curable stis worldwide [ ] . some of the commonly seen non-communicable diseases include obesity and psychological problems in migrant children [ ] . obesity could be due to stress or change in dietary habits. vitamin d deficiency is often caused by lack of exposure to sunshine in winter [ , ] . other conditions like malnutrition and multivitamin deficiencies are most likely to be prevalent too due to lack of access to food and health care in the migration journey. as per unhcr data, about , of refugee children in were unaccompanied minors [ ] . segregation from parents can be harmful to a child's health and prosperity, mostly mental health, as parents lay the foundation for the societal and environmental base for children [ ] . unaccompanied refugee minors have a higher prevalence of psychiatric disorders than accompanied refugee peers [ ] . when accompanied by families, and after having experienced the migration trauma, children are often "hidden from sight" with no regard to their own personal wishes. mental health must be seen as a complex primary healthcare need and should be served in a holistic and family-oriented manner whenever possible. research studies have shown that freshly arrived migrant and refugee juveniles are at a high risk of psychosocial and mental issues due to exposure to organized crime and migration stress [ ] . these are most commonly internalizing disorders -anxiety, depression, and post-traumatic stress disorder (ptsd) [ , ] . a study of asylum seekers with serious mental health problems, in the netherlands, found that parental symptoms of ptsd were associated to infants' troubled attachment and that parental apathy was related to parental ptsd [ ] . a cohort study found that caregivers' ordeal history and postmigration adversities were correlated with greater ptsd, rigid parenting, and an increase in child conduct problems [ ] . expressive symptoms, however, were found to be equal to that in children of the host country [ ] . longitudinal studies have shown that the high rate of internalizing symptoms tended to wear off slowly over a period of time, with expressions of ptsd fading away in about seven years after arrival to the host country [ ] . some frequently reported emotional and behavioral mental health problems among bhutanese refugee youth include fighting, loneliness, depression, and being scared. other symptoms of oppositional defiant disorder, intermittent explosive disorder, conduct disorder, generalized anxiety disorder, major depressive disorder, and disruptive mood dysregulation disorder were also seen among them [ ] . migrant and refugee juveniles frequently have to compromise more when parents are suffering from psychiatric disorders after dreadful experiences and migration strain. parents with mental health challenges battle to give their children a feeling of support and stability [ ] . migration stress with socioeconomic deprivation takes a toll on the parents and increases the risk for child abuse [ ] . early and adequate cognitive, mental, and emotional support for parents suffering from behavioral disorders is thus a vital support for children. refugees may hesitate to seek mental health help due to a culturally based stigma around mental health issues [ ] . family separation and parental death drives adolescents to take on parental roles for younger siblings. recognition of these roles will enable physicians to provide suitable emotional and social support. risk factors in the host country, such as financial hardships, parental separation, and aggression/bullying, were analyzed as vital determinants of mental health at follow-up [ ] . in recent years, cognitive behavioral psychotherapy, eye movement desensitization and reprocessing (emdr), and narrative exposure therapy for migrant and refugee children who have experienced war and displacement have been established for the evaluation and treatment of ptsd and depression [ ] . strengths of refugee children include personal resilience, parental support, close-knit family structure, and lasting association with their religious and cultural identity from the country of origin [ ] . the staggering majority, %, of the global refugee population is accepted in developing regions with limited access to quality mental health even before the pandemic [ ]. now, they are overwhelmed with mental health crisis, as warned by the unhcr. while many refugees and internally displaced people are exceptionally resilient, their abilities to cope are now being stretched to the limit. the loss of daily wages and livelihoods is taking a toll on their mental health and causing psychosocial hardships. social distancing measures and limited mobility are compounding emotional distress with reports of self-harm increasing among the refugees. the covid- precautions and reduced staffing levels during this pandemic are also impacting the availability of aid and mental health support as refugees are often unable to travel, and many face-to-face activities have been cancelled. the unhcr is stepping up efforts to ensure the continuity of care by providing mental health services remotely through multi-lingual telephone hotlines and over the internet through online sessions. in addition, they are ensuring that people who need medication can continue treatment during lockdown [ ] . the teaching recovery techniques approach is used to decrease children's discomfort and post-traumatic symptoms and to improve peer and kinfolk relations [ ] . this psychosocial intervention is meant for juveniles who have experienced dreadful circumstances. children are assembled in organized groups focused at augmenting emotional management, survival competency, and conflict resolution skills. these techniques also help the children to express themselves. there is also a parent component session to educate about intervention and on skills to reinforce care of their children. ladnaan intervention is a culturally adapted parenting guidance program combined with local civic orientation for somali-born parents living in sweden. a trained community educator of somali origin facilitates the program. parents report higher success and satisfaction after completing the course and convincing improvement in behavioral problems in their children. in this -week session, parents are educated on local community information, receive lectures and take part in workshops, and exchange views on the parent-child liaison, attachment, child growth, and development of interpersonal skills [ ] . mind-spring is a mental health disorder prohibition plan in belgium, denmark, and the netherlands. it provides psycho-education, and psychosocial and parenting skills for refugee and asylum-seeking parents in a culturally conscious manner in their own native language [ ] . it deals with topics on mental health such as stress, ordeal, depression, personality, acculturation, and mental health fitness. the program promotes exchanging thoughts on experiences and provides parents with information about mental health expertise to recognize signs of suffering and mental ailment in themselves. it also educates the parents about obtaining help if and when needed. parents also obtain the required skills and support in the parenting process and how to ploy collateral parenting issues. studies have shown that educational institutions play a vital role in conserving and promoting the health and well-being of refugee and migrant children. successful school-based mental health prevention requires experts trained in cultural proficiency, who can interpret the mental health requirements and risks of refugee and migrant children, and who can conform the learning program to the needs of the individual child and family [ , ] . hearing all voices was a pilot project undertaken by child to child in london aimed at promoting social inclusion, commitment in education, and local community involvement among vulnerable youth, with a prime focus on refugee, migrant, and asylum-seeking youth [ ] . the pharos school prevention program conducts classroom-based program in the netherlands with the aim of developing social involvement among migrant children with local host community children and adults while simultaneously attending to individualized requirements of each child [ ] . health assessments are performed for refugee and migrant children in a school setting in malmo city, sweden. here, the school nurse meets the juveniles and their caregivers for a health assessment to define and address each child's healthcare requirements. an analytical interview is followed by a broad general examination of the body, including dentition, eyesight, and hearing. mental health is briefly assessed and vaccination history is analyzed. referrals are made based on the necessity of specialized services. national governments have a significant role in establishing living circumstances for refugee and migrant children as most freshly settled refugee families rely on national and local authorities' support for habitation and existential expenses. governments determine the rights of children to access health care maintenance and educational benefits in their country. policies that exemplify humanity should be planned and implemented for the refugees/migrants and asylum seekers. a detailed individualized health evaluation by a healthcare professional on arrival to the host country should determine the healthcare needs and screen for communicable diseases; disability should be assessed and vaccinations should be updated. this response will help detect infections early on, allow timely treatment to be given, and will be most cost effective in the long run. the availability of medical translators and native cultural arbitrators is important to ensure the best healthcare outcome for refugee and migrant children. blueprints to improve welfare, and access to education and health in refugee and migrant children should have a comprehensive framework that targets risk factors on individual, family, and community levels. culturally sensitive, parent and other caregiver support curriculum and interventions in the school and local community centers should be promoted. transferring children between multiple locations should be minimized as it disrupts the peer networks and educational flow; this also holds good for unaccompanied children with substitute caregivers. in order to build good relations with substitute caregivers, unaccompanied children need consistent long-term, definitive housing with the same guardians. the most vital physical, social, and psychological support for children are their parents; therefore, family reunions should be expedited [ ] . the united states of america has built the largest immigration detention system in the world. in , a staggering , migrant children including infants, toddlers, kids, and teens were held in custody in facilities across usa. these facilities lack enough clinicians or specialized care for the detained children [ ] . immigration detention has adverse and detrimental consequences for the well-being of those detained, but studies have found that it is most inimical to children [ ] . the negative impacts of detention on mental health are more brutal for children than for adults; therefore, detention should not be weaponized for deportation of migrant children. if this is inevitable, then the facilities harboring children should have childfriendly areas, and avenues for healthcare and education should be provided. children on the move also suffer brutality, injustice, and misconduct from law enforcement officials -local police, border guards, and detention officers. such events cause children to quickly learn to mistrust authorities. these adverse psychological effects may last years after release from detention [ ] . children are global citizens and their rights move with them; therefore, their healthcare needs should not be defined by geographic borders. mounting evidence suggests welcoming and supportive policies for refugee, migrant, and asylum-seeking children can prevent psychological distress and mental health disorders in these vulnerable children. all-inclusive policies that aim at protecting the rights of every child should be enforced globally. children should not be held in detention centers indefinitely in subhuman conditions away from their parents/primary caregivers. reuniting children with their families should be prioritized and expedited. it is imperative to enforce preventative mental health policies and refrain from practices that abuse human rights. healthcare providers should consider volunteering in refugee and migrant camps, and also in local community free clinics that are accessed by refugee and migrant children. this will ensure adequate staffing in detention facilities specially during the pandemic where the invisible, voiceless, and vulnerable refugee and migrant children along with the adult refugees and migrants can get timely medical attention and treatment for their healthcare needs. research is needed on improving resilience building and for appraising the impact of precise interventions that could improve outcomes. more longitudinal studies are needed to assess interventions that increase better mental health mediterranean situation health of refugee and migrant children: technical guidance . who regional office for global trends -forced displacement latest statistics and graphics on refugee and migrant children health considerations for immigrant and refugee children migrant children in europe: entitlements to health care. models of child health appraised barriers to access to health care for newly resettled sub-saharan refugees in australia structural and socio-cultural barriers to accessing mental healthcare among syrian refugees and asylum seekers in switzerland rights of accompanied children in an irregular situation a systematic review of risk and protective factors associated with family related violence in refugee families assessing the burden of key infectious diseases affecting migrant populations in the eu/eea infectious diseases of specific relevance to newly-arrived migrants in the eu/eea multidrug-resistant bacteria in unaccompanied refugee minors arriving in frankfurt am main measles among migrants in the european union and the european economic area toward global prevention of stis): the need for sti vaccines the health of migrant children in switzerland serum levels of -hydroxyvitamin d in mothers of swedish and of somali origin who have children with and without autism high prevalence of somali population in children presenting with vitamin d deficiency in the uk. arch dis child risk of mental health and nutritional problems for left-behind children of international labor migrants incidence of psychiatric disorders among accompanied and unaccompanied asylum-seeking children in denmark: a nation-wide register-based cohort study mental health problems of syrian refugee children: the role of parental factors mental health in syrian refugee children resettling in the united states: war trauma, migration, and the role of parental stress the effect of post-traumatic stress disorder on refugees' parenting and their children's mental health: a cohort study prevalence of serious mental disorder in refugees resettled in western countries: a systematic review attachment representation and sensitivity: the moderating role of posttraumatic stress disorder in a refugee sample we left one war and came to another: resource loss, acculturative stress, and caregiver-child relationships in somali refugee families exile and mental health in young refugees the transmission of trauma in refugee families: associations between intra-family trauma communication style, children's attachment security and psychosocial adjustment psychological interventions for post-traumatic stress disorder and depression in young survivors of mass violence in low-and middle-income countries: meta-analysis unhcr urges prioritization of mental health support in coronavirus response interventions for children affected by armed conflict: a systematic review of mental health and psychosocial support in low-and middle-income countries klingberg-allvin m: a support program for somali-born parents on children's behavioral problems school and community-based interventions for refugee and asylum seeking children: a systematic review hearing all voices in london us held record number of migrant children in custody in global protection and the health impact of migration interception mental health of unaccompanied asylum-seeking adolescents previously held in british detention centres key: cord- - uhpkhr authors: ray, kristin n; ettinger, anna k; dwarakanath, namita; mistry, sejal v; bey, jamil; chaves-gnecco, diego; alston, kaila a; ripper, lisa; lavage, daniel r; landsittel, douglas p; miller, elizabeth title: rapid-cycle community assessment of health-related social needs of children and families during covid- date: - - journal: acad pediatr doi: . /j.acap. . . sha: doc_id: cord_uid: uhpkhr objective: to identify unmet health and social resource needs during a county-wide covid- stay-at-home order and phased re-opening in western pennsylvania. methods: with public health, social service, and community partners connected through an ongoing academic-community collaborative, we developed and fielded a weekly repeated cross-sectional electronic survey assessing usage of and unmet need for health and social service resources. using ten weeks of surveys (april -june , ) by allegheny county residents, we examined variation in responses by week and by sociodemographic characteristics using chi-square tests. we shared written reports weekly and discussed emerging trends with community partners. results: participants ranged from - , per week. unmet need for at least one health or health-related social need resource varied by week, ranging from % ( % confidence interval (ci) - %) of participants in week to % ( % ci - %) of participants in week (p= . ). increased use of at least one resource ranged from % ( % ci - %) of participants in week to % ( % ci - %) in week (p< . ). unmet need for food and financial assistance peaked early during the stay-at-home order, while unmet need for mental health care rose later. unmet need for food assistance varied significantly by race and ethnicity and by household pre-pandemic income. conclusions: over half of families with children reported unmet health or social service needs during the first month of a county-wide covid- stay-at-home order. unmet needs varied with race, ethnicity, and income and with duration of the stay-at-home order. covid- and associated public health measures (e.g., physical distancing; closure of schools, childcare, and businesses) have the potential to stress and strain the ability of parents, families, and communities to meet children's material, health, emotional, educational, and social needs. , because of historical and current unequal allocation of resources in the united states, these burdens fall most heavily on children living in poverty and children identifying as black or hispanic. , while public health, social service, health systems, and community organizations rapidly adapted to support families and children during covid- , community organizations in our ongoing academic-community research collaborative expressed a need to ascertain specific unmet needs. the rapidly evolving nature of the pandemic and public health response was expected to result in continuously shifting policies and priorities, with these potentially translating into shifting unmet needs over time. to inform ongoing multi-sector efforts to support children and families during covid- , we launched an initiative involving weekly surveys of caregivers of children in southwestern pennsylvania paired with weekly reports to public health, social service, medical, and community organizations. survey items were informed by prior community-engaged concept mapping of thriving in childhood and underwent multi-stakeholder review. in this report, we summarize health-related social needs and resource use during the first ten weeks of this ongoing survey as an example of how research infrastructure can support public health and social service response during public health emergency by identifying the evolving consequences of disrupted public infrastructure on children and families with multi-sector partners connected through an ongoing academic-community collaborative (the pittsburgh study ), we developed an online and telephone family strengths survey addressing domains of childhood thriving, health-related social needs, and family demographics in english and spanish. regarding resource use and unmet needs, families were asked to identify ( ) any resources they had used more than usual in the prior week and ( ) any resources with which they needed more help than they were currently getting. resources included in the responses including food assistance (food banks, school distribution sites, supplemental nutrition assistance program), financial assistance (cash assistance, unemployment benefits, financial support for utilities), physical health care (medical care, outpatient therapy, medical supplies), mental health care (behavioral health, substance use disorder treatment), child care, and educational support (e.g., special education services, individualized education program services). starting april , , we administered the repeated cross-sectional survey weekly, with weekly distribution occurring via multiple list-servs, social media, local press, community ambassadors, and texts/emails to participants from prior weeks who opted into further contact. responses were anonymous with no longitudinal linking. participation did not yield access to any specific resources or case management, but respondents were directed to online information about local resources at the end of the survey. adults in western pennsylvania with children under years old in their household were eligible to participate. every week participants were randomly selected to receive gift cards. this study was reviewed by the university of pittsburgh institutional review board and determined to be exempt. this analysis focuses on resource use and unmet need items among participants residing in allegheny county, where approximately % of children under years old live below the poverty level, and % of children were food insecure in . allegheny county was under a stay-at-home order at the beginning of the survey period, and underwent phases of re-opening on may , (yellow phase) and june , (green phase). sampling weights were applied to align the sample each week to population benchmarks based on county demographics for race, ethnicity, and household income ( % of residents identify as non-hispanic white, % of residents as non-hispanic black, % as hispanic, % as asian, and % as two or more races; median pre-pandemic income was $ , ). we used chi-squared tests to compare resource use and unmet needs across weeks. we did not perform tests for trends because we did not assume the presence of monotonic trends. we used chi-squared tests to compare unmet needs by sociodemographic variables within individual weeks, limiting such analysis to weeks where absolute number of participants in each category exceeded . writein responses were qualitatively analyzed using content analysis. we developed weekly reports to share with public health, social service, and community organizations to inform local responses to the pandemic. we disseminated topic sheets and infographics highlighting family experiences and potential resources online and through community partners. during this ten week period, we gave virtual presentations about survey results to pediatrician groups, academic medical center leadership, health system service employee leaders, county department of human services and affiliated social service agencies, virtual town hall meetings of black residents, latino-serving community organizations, local news, subgroups of the pittsburgh study academic-community research collaborative, and myriad other partners. in response to feedback from these presentations, we phased in additional survey modules from week to week and we generated specific reports to share with these partners based on their informational needs. through these meetings and weekly team meetings, we continually sought to center equity and enhance impact through reflection on our data collection, analysis, reporting, and dissemination. weekly participation by residents of allegheny county ranged from to , individuals ( table ). in the weighted sample, most participants were - years old, identified as female, and were from english-speaking households. unmet need for at least one resource addressing health or health-related social needs varied by week, peaking at % ( % confidence interval (ci) - %) of participants in week and declining to % ( % ci - %) of participants in week (p= . ). increased use of at least one resource was reported by as many as % ( % ci - %) of participants in week and declined to % ( % ci - %) in week (p< . ). unmet need for specific resources and services followed different trajectories over time ( figure ). for example, unmet need for food assistance and financial assistance peaked during early april. for food assistance, unmet need in the absence of resource use continued to decline over subsequent weeks. for financial assistance, unmet need in the absence of resource use began to rise again in may. still other needs, such as mental health care, rose later during the stay-athome order and the partial reopening of the county in early may and late may, respectively. write-in survey responses provided additional context to these trends, such as the difficulty single parents experienced with grocery shopping even in the context of receipt of special within individual weeks, we also compared unmet needs by pre-pandemic income and by participants self-identified race and ethnicity (figure illustrates the data from week ). participants from households with pre-pandemic incomes of less than $ , were significantly more likely to report unmet needs for food assistance ( . %, % ci: . - . %) than individuals reporting higher pre-pandemic incomes (income $ , - , : . %, % ci: . - . %). participants from households with pre-pandemic incomes of less than $ , were also significantly more likely to report unmet needs for financial assistance ( . %, % ci: . - . %) than individuals reporting higher pre-pandemic incomes (income $ , - , : . %, % ci: . - . %). the percentage of families with unmet needs for physical health care, mental health care, educational support, and childcare during this week did not vary with pre-pandemic income. participants identifying as black and latinx were more likely to report unmet need for food assistance than participants identifying as white ( . % ( % ci: . - . %) of black participants, . % ( % ci: . - . %) of latinx participants, and . % ( . - . %) of white participants). unmet needs for financial assistance, physical health care, mental health care, educational support, and childcare during this week did not vary significantly by race or ethnicity. during the first month of a county-wide stay-at-home order due to covid- , over half of families with children reported unmet health or social service needs. unmet need for food and financial assistance varied over time and with race, ethnicity, and income. these shifting community needs occurred in the context of evolving local contexts: local food bank lines drew national coverage during week , local school districts launched remote learning as late as week , and businesses and childcare began a partial re-opening at the beginning of week with expanded re-opening in week . during these weeks, allegheny county reported relatively low covid- case rates ( cases per , residents), and with a % casefatality rate among identified cases. as of september , allegheny county cases have risen to per , residents. through rapid-cycle data collection and analysis, we provided weekly reports of population-level health-related social needs with community partners spanning social services, public health, medical providers, and community organizations to inform local covid- pandemic response. by sharing weekly written reports and convening virtual meetings with a wide range of partners, these data allowed continued multi-sector priority-setting focused on the health-related social needs of families. for example, we reviewed in meetings with multiple community partners the characteristics and write-in comments from respondents reporting ongoing barriers to food resources, including that public benefits were only accepted at stores without home delivery, that shopping with young children felt unsafe, and that formal and informal childcare was not available. community agencies used these data to inform their decision to substantially scale up food home delivery services for families, which complemented existing community strategies such as grab-n-go meals at local schools. as a second example, in response to persistent unmet mental health care needs, we used these data to normalize the need for mental health services for children and parents in our messaging on local news media, social media, and online reports. we also shared results with mental health providers and social service agencies. together, we developed community-facing materials sharing these data and highlighting available local virtual and tele-mental health services. we also partnered with social service agencies to develop and field a panel of questions about reasons for unmet mental health care needs in a later week of the survey to provide them with further actionable data. third, the ongoing weekly format of the survey also allowed us to adapt questions to further inform response. for example, as our county prepared for partial re-opening of businesses and anticipated unmet need for childcare rose, we partnered with local child-serving organizations to include additional childcare-related questions to help plan for potential demand for and concerns about childcare, recognizing that an estimated % of the general workforce are individuals with children under years old and no dependable family caregiver options when they return to the workforce. in addition to identifying and acting on these shifting trends across the county, we used these data to highlight need for services by sociodemographic characteristics, providing local context to concerns noted nationally. , when examining results by pre-pandemic income, in families with less than $ , pre-pandemic income reported unmet food assistance needs and nearly half of families with less than $ , pre-pandemic income reported unmet financial assistance needs within a single week. these data also demonstrated increased unmet need for food and financial assistance among participants identifying as black and as latinx, illustrating disparities in health-related social needs in the midst of a pandemic already unequally impacting these communities. we shared these data first with local black and latinx community leaders to discuss strategies for disseminating and addressing these needs. in partnership with community organizations, materials highlighting local resources intentionally featured black-led community organizations offering resources in areas ranging from financial assistance to mental health services to virtual doulas. these data were also used to convene multi-partner conversations about improving awareness of and access to pandemic relief services for spanish-speaking and other low-english proficiency families including improving awareness and experience with local service provider hotlines. due to these local findings and national concerns about significant differences in health and financial consequences of the pandemic by race and ethnicity, , we worked with community partners to enhance and sustain representative survey participation. through releasing a spanish-language version of the survey in week and dissemination of the survey on social media channels by trusted community members and organizations, weekly participation by individuals identifying as latinx peaked at % of survey participants in week (in a county where % of the population identifies as latinx ). through similar dissemination strategies, the percentage of participants identifying as black nearly reflected the percent of the county identified as black during weeks - , but were lower in subsequent weeks. by weighting survey responses across race, ethnicity, and pre-pandemic income, we seek to ensure that black and latinx perspectives are represented across weeks, although absolute numbers of participants in later weeks limited our ability to compare weekly results by race and ethnicity. while we sought to make the survey accessible through telephone and online options, english and spanish versions, and partnering with community ambassadors, clearly ongoing barriers remain. recommendations from community partners to support more representative participation have included changing participant incentive structure, altering survey items to reduce emotional burden, and on-site paper or tablet-based administration at community resource hubs. some limitations of survey data stem from intentional design decisions. we designed the survey to optimize participation and rapidity of results and to capture changes in priorities over time. based on partner input, the survey was broadly available, was anonymous, did not track individuals over time, and was not limited to individuals in an initial sampling frame. to account for these design limitations, we employed sampling weights to balance shifting sociodemographics from week to week. however, within these weighted strata, these is still the possibility of selection bias overall or from week to week. one specific possible selection bias additionally, the weekly survey items do not delve into reasons for unmet need, which could be due to not contacting a service, being denied a service, or awaiting decisions on eligibility for a service. based on results of these initial weeks of data, we worked with partners to field additional questions about specific unmet needs (food, housing, mental health care) in later individual weeks, but these questions were not asked weekly to reduce survey burden to participants. despite these limitations, this initiative has provided public health, social service, health system, and community organizations with timely data to inform ongoing response to the physical, mental, educational, and social challenges covid- and stay-at-home orders presented to children and families. these data underscore the magnitude of unmet needs experienced by families during the pandemic-related stay-at-home order, the shifting unmet needs as programs, policies, and responses evolved, and the degree to which these unmet needs were unequally distributed across race, ethnicity, and family income. our experience also illustrates how research and research infrastructure can pivot to support the crucial work of public health, social service, health system, and community partners during public health crises and demonstrates the value of ongoing academic-community partnerships to support rapid communication of data needs and findings. mitigating the impacts of the covid- pandemic response on at-risk children rapid systematic review: the impact of social isolation and loneliness on the mental health of children and adolescents in the context of covid- low-income children and coronavirus disease (covid- ) in the us covid- and racial/ethnic disparities a community partnered approach for defining child and youth thriving child food insecurity in pennsylvania a toolkit for centering racial equity throughout data integration never seen anything like it': cars line up for miles at food banks city schools prioritize student engagement as remote learning begins announces counties will move to yellow phase of reopening on allegheny county covid- information feeding low-income children during the covid- pandemic coronavirus disease (covid- ) and mental health for children and adolescents childcare obligations will constrain many workers when reopening the us economy the covid- pandemic is straining families' abilities to afford basic needs covid- exacerbating inequalities in the us table : weighted and unweighted participant characteristics in weekly repeated cross-sectional surveys, april -june , week apr - week apr - week apr - week apr - week may - week may - week may - week may - week may -june week june - weighted % (unweighted n) note: weighted percentages may not sum to due to rounding, and unweighted numbers may not sum to weekly total due to participant non-response to specific items. the item inquiring about essential workers in the household was added in week . week ) with unmet need for specific resources (regardless of resource use in the prior week) by pre-pandemic income and by self-identified race and ethnicity. * indicates significant differences in unmet need for resources (p< . ) using chi-squared tests. key: cord- -hspek authors: timmis, kenneth; brüssow, harald title: the covid‐ pandemic: some lessons learned about crisis preparedness and management, and the need for international benchmarking to reduce deficits date: - - journal: environ microbiol doi: . / - . sha: doc_id: cord_uid: hspek nan if, despite the explicit warning of the world health organization in that 'the world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public-health emergency' (https://apps.who.int/gb/ebwha/pdf_files/wha /a _ en.pdf), it was not apparent to those in charge, and to the general public-i.e., those suffering from covid- infections and the funders of health services (tax/insurance payers)-that existing health systems had inherent vulnerabilities which could prove to be devastating when seriously stressed, the sars-cov- pandemic (e.g., see brüssow, ) has brutally exposed it now. in some countries, preparedness, despite being officially considered to be of strong operational readiness against health emergencies (kandel et al., ) , was inadequate at multiple levels (e.g., horton, ) . similarly, a fundamental lack of preparedness is the case for a number of impending non-health crises (e.g., global warming, poverty, the soil crisis, etc.). once we are over the covid- pandemic, important questions will be: what have we learned/can we learn and how can we improve our systems? below, we argue for the necessity for major realignment of crisis responsiveness, and indeed of health system operationality, based on international benchmarking and adequately funded preparedness. international benchmarking is mandatory, because it has become clear that there is a wide range of effectiveness in the ability of different countries with developed economies to respond to this crisis (and probably others), and the tax-paying public has no compelling reason to tolerate perpetuation of factors underlying poor responses to crises. disparity in country/regional responses to sars-cov- leaving aside for the moment decisions about whether to robustly contain the outbreak-to kill it by throttling-the classical strategy of infection control, but which leaves most of the population susceptible to a new outbreak, or attempt to manage an outbreak to achieve herd immunity and a population unsusceptible to a repeat outbreak, it is obviously imperative to know how the outbreak is spreading and how effective are any containment measures that are instituted, so that a change in course of action remains an option. widespread testing for the viral pathogen, with correct sampling and analysis procedures, is thus essential. this enables, inter alia, calculation of reliable mortality (case fatality) rates, which ordinarily play a key role in determining crisis response policy, calculation of the basic reproduction number, r , and reliable modelling of transmission and mortality trends. there have been enormous differences in testing coverages among countries. early predictions of transmission and mortality trends are only as good as the adequacy of the information fed into models so, with inadequate testing, prediction of trends are unreliable. mortality-based policy formulation for sars-cov- responses in some countries was based on incomplete information. • diagnostics and widespread testing are the basis of informed policy development for crisis management of infectious disease epi/pandemics and must become its centrepiece the disparity of sars-cov- testing coverage in different countries is much discussed but the reasons are sometimes rather opaque. there are many tests available (e.g., see https://www.finddx.org/covid- /pipeline/), so one bottleneck would appear to be a limitation in authorized testing facilities. scaling up testing in existing official centres requires not only acquisition of the appropriate instrumentation and reagents, but also of competent personnel disposing of the necessary expertise, which may constitute a bottleneck. however, it is abundantly clear that the instrumentation and expertise needed to carry out sars-cov- testing are widespread in academic research laboratories, as is the eagerness of many research groups to contribute to efforts to combat the pandemic. while issues of safety, quality control, logistics, data reporting and security and so on, need to be addressed, a failure in some countries to harness early in the crisis the expertise and enthusiasm of young researchers to fulfil a key need and, with it, the opportunity to acquire data that could have resulted in responses that saved lives, is regrettable. paradoxically, while there have been frantic efforts to open new hospital facilities to accommodate covid- patients, and to recruit the health professionals needed to operate them, there has been an indiscriminate closing of research institutes capable of carrying out diagnostic work, and thus of identifying infected and, importantly for frontline health professionals, non-infected individuals. • rapidly developing pandemics necessitate rapid responses. getting diagnostics and testing facilities up and running that are able to handle large numbers of samples are key to efforts to manage the disease. crisis preparedness demands not only formulation of strategies to enable rapid scale up official facilities, but also advance identification of relevant available resources outside of the health system, and strategies of how to promptly and effectively harness them. widespread testing for viral rna must be complemented by widespread testing, or at least the testing of sentinels of the population, for anti-viral antibodies. this is essential for relating the dynamics of infection to virus shedding (being infectious = infective for others) and to symptom development. and if (and this is a big if) the presence of antiviral antibodies reflects protective immunity, antibody testing is essential for herd immunity policy scenarios, to provide the data needed for monitoring and modelling immune population densities/granularity, and also for identification of those in the population who are in principle protected and hence able to return to normality and spearhead safe exit strategies from lockdown measures. • contingency planning requires identification of facilities or alliances able to promptly develop, produce in quantity and distribute easy-to-use antiviral antibody tests. patients having contracted covid- are grouped into three categories: in the china outbreak, % experienced mild, % severe and % critical infections (wu and mcgoogan, ) . for those requiring hospitalization, and those with the most acute symptoms requiring intensive care, two key variables in treatment capacity seem to be bed availability generally, and in intensive care units particularly (images of patients lying on the floors of some hospitals made this abundantly clear to the entire world), on one hand, and ventilator/intubation tube availability for patients needing intubation, on the other. there are enormous differences between countries in terms the availability of hospital beds/ population (e.g., japan . , germany . , france . , switzerland . , italy . , uk/canada/denmark . , india . : https:// data.oecd.org/healtheqt/hospital-beds.htm), icu beds/ population, and numbers of available ventilators/intubation tubes (here, ventilators can be considered a proxy for any other clinical device that may be needed in a health crisis). an insufficiency of beds (and often health professionals) also resulted in 'non-critical' interventions being postponed in some countries, and who, among critically ill patients suffering from different ailments, should be given an icu bed. there are different reasons for insufficient beds and clinical devices. but the fact remains: some countries manage better than others; some countries do not have enough beds for even small increases representing normal fluctuations in patient needs and anticipated seasonal variations, let alone exceptional demands made by epidemics. • it is essential to increase bed, especially icu bed, capacities in many countries, in order to reduce stress situations where patients cannot receive required treatment, and to prevent hospitals from being overwhelmed in times of crisis, when there is a spike in patients requiring hospitalization. one new development triggered by the covid- pandemic was the creation of so-called 'fangcang shelter hospitals'-rapidly constructed, large scale, low cost, temporary hospitals, by converting existing public venues into healthcare facilities in wuhan to manage the rapidly increasing covid- patient numbers (chen et al., ) . instead of being delivered to regular hospitals, covid- patients were sent to shelter hospitals, where they were isolated and received basic medical care and frequent monitoring. patients whose mild disease state transitioned to severe were then transferred to regular hospitals where they received intensive care. although new emergency hospitals have been created in other countries, the purpose of these is generally to receive spillover from traditional hospitals, when these become overwhelmed by patient numbers. the purpose of fangcang shelter hospitals is, in contrast, to centralize clinical management of the epi/pandemic outside of the traditional hospital system. covid- patients are channelled to shelter hospitals, thereby minimizing viral ingress into hospitals and infection of health professionals, and helping to maintain staffing levels and normal functioning of outpatient and inpatient facilities. it is important to note that shelter hospitals constitute low-cost clinical settings-they require fewer health professionals and diagnostic-treatment infrastructure than normal hospitals, because all patients have the same clinical issue and most have only mild-to-moderate disease-and thereby relieve pressure on traditional hospitals with sophisticated infrastructure in limited capacity that constitute high-cost clinical settings (the creation of parallel low-cost clinical settings to relieve pressure on limited capacity high cost clinical settings is more broadly applicable over and above epi/pandemic response situations: see timmis and timmis, , for an example in primary healthcare). • shelter hospitals should be incorporated into pandemic planning as the primary destination for pandemic patients, to allow traditional hospitals to continue functioning as normal as possible (or normally as long as possible). it may seem so trivially obvious to say, but obviously needs saying because it was not apparent from the health system responses of a number of countries: those most at risk of infection are those in contact with the infected, i.e., front-line doctors and nurses. and as they become infected, the numbers of available health professionals left to treat patients goes down as patient numbers go up. and, of course, infected health professionals become transmitters of infection among one another, and to uninfected patients, since in the hectic reality of emergencies, they may not always be able to practice adequate physical distancing. this obviously means that the greatest protection from infection must be accorded the front-line professionals. however, there were substantive differences between countries in terms of the availability and use of best practice protective clothing (personal protective equipment, ppe) in the early days of the covid- crisis; these differences were mainly in different degrees of deficiencies. the incomplete protection of front-line health professionals that occurred in a number of countries in the early days of the crisis, and that resulted in many infections and some deaths, is an unacceptable deficit in their health systems, particularly since the covid- outbreak was, from end of january , a predictable disaster of international magnitude. then there are those one might designate accessory front-line professionals: those who transport infected individuals, like ambulance drivers, non-medical workers in hospitals, and so forth, carers ministering to people in care homes or in private homes, and others like some pharmacy and supermarket staff who, because of the nature of their work, come into physical contact with many people and cannot always achieve prescribed physical distancing. these are also particularly vulnerable to infection and to becoming infection transmitters. since the people they care for are, because of their ages and underlying morbidities, often themselves particularly vulnerable to severe outcomes, infected carers may, unknowingly and unwillingly, become 'angels of death'. accessory front-line professionals thus also require best ppe. there are wide regional and occupational differences in the availability and use of such clothing by these professionals. in addition to the issue of ppe, there is the issue of hygiene in the workplace-the surfaces that become contaminated and sources of infection. while traditionally these have been cleaned by auxiliary staff, such people are themselves at considerable risk of being infected in such environments and, as a result, there may be an insufficient number to continue carrying out this task, thereby raising infection risk. robots are in principle able to carry out various mechanical operations, so might take an increasing share in disinfection of high-risk, high touch areas (e.g., robot-controlled noncontact ultraviolet surface disinfection), and indeed other hospital tasks, such as delivering medications and food, diagnostic sample collection and transport, and so forth, (yang et al., ) , that may reduce both the work burden of overstretched staff and their infection risk. • the incorporation of robots into appropriate hospital operations should be energetically explored leadership in times of crisis is crucial to ongoing damage limitation and outcome severity, quite apart from its importance in planning crisis preparedness. although we need to look back when all this is over, and take stock of what went right, what was wrong, and what went wrong (i.e., to perform a gap analysis), at this point it seems that most countries were on their own, acting largely independently of others during the sars-cov- outbreak, at least in the early days. however, a pandemic is by definition an international crisis, requiring an international response (national-self-interest-policies may even be counterproductive in times of pandemics). extensive and effective cooperation, coordination and sharing of resources were not evident (e.g., see herszenhorn and wheaton, ) . leadership quality and effectiveness varies significantly among countries and among relevant international agencies. where leadership is suboptimal, dissemination of misinformation flourishes, and people are subjected to unnecessary levels of uncertainty and associated stress. • effective and decisive, biomedical science-guided, national and international leadership and coordination is absolutely crucial in pandemics, to prevent-hindermanage-minimize damage, acquire-integrate-learn from collective experience, make recommendations for crisis management, publish best practice procedures and standards. there is significant room for improvement. it is well known that experts have been warning of impending deadly epi/pandemics, including coronavirus outbreaks, for a long time (e.g., turinici and danchin, ; ge et al., ; menachery et al., ; https:// www.ted.com/talks/bill_gates_the_next_outbreak_we_re_ not_ready?language=en; editorial ( ) predicting pandemics, lancet doi: https://doi.org/ . /s - ( ) - ; https://apps.who.int/gpmb/assets/annual_ report/gpmb_annualreport_ .pdf; https://www. weforum.org/agenda/ / /a-visual-history-ofpandemics/). now while the nature, evolution, timing and source of novel emerging infectious agents is uncertain, pandemics are always counteracted by the same timehonoured strategy: interruption of infection chains and anticipation of a surge in need for treatment of acute disease (here, we are nearly in the same situation as in the world confronted by spanish flu in ). we, therefore, only need one epidemic preparedness. despite this, the sars-cov- outbreak has clearly exposed how unprepared we were. there are multiple reasons for this, including. contingency planning is long term, lacks immediacy and 'wow factor' and so may not always enjoy high political priority, and thus is often neglected a primordial responsibility of government is to protect its citizens. this includes effective contingency planning for pandemics. however, due to the global nature of pandemics, coordination with neighbours (and factoring in potential flashpoints located more distantly, such as refugee camps in greece and elsewhere, which could become, if not cared for, sources of a second wave of infection when the first is over), and intergovernmental cooperation is essential. adequate contingency planning for deadly and devastating infectious disease outbreaks is not an optional policy, and the public have the right to insist on it, even if it becomes politically or economically expedient to neglect. for the public-the key stakeholders in this-transparency is essential and it must have access to information on the current state of preparedness, and future plans of government, and those of different political parties during election campaigns. trusted biomedical science organizations must support the public in this by providing expert scrutiny and assessment. governments must become accountable for the efforts they make to protect us. • governments must engage the public in issues of crisis preparedness and publish their contingency plans for scrutiny. • scientific organizations should have press/web groups that become trusted sources for evidencebased information for the public. catastrophe prediction/management expertise is not always at the heart of government, and thus able to inform and influence policy governments establish the presence of experts in key posts for topics they consider to be vital for informed policy and legislative activities. such experts exert an influence in policy development by providing input that is upto-the-minute in a changing world. while some governments contain epidemic/catastrophe experts, others do not. without such expertise, responses to catastrophes will generally be slow, ad hoc and inadequate, as has been the case in some countries in responding to the sars-cov- outbreak. for governments to fulfil their responsibilities to protect their citizens, it is essential that they have expert-informed contingency planning. learned societies and academies also have a major responsibility to seek to inform and influence government. the royal society, uk, and the american society for microbiology exemplify strategic influencing of national and international policy; other learned societies could be more proactive. • expert scientists must be embedded in the heart of government to enable development of evidencebased informed policies contingency planning involves inter alia the acquisition and maintenance of resources, such as beds, icu capacity, stocks of ventilators, protective clothing, and so forth, in the case of pandemics (e.g., kain and fowler, ) , that are by definition surplus to day-to-day requirements, and that will only be used if and when the catastrophe occurs. it also includes the development of generic platforms for rapid responses; in the case of pandemics, the development and testing of diagnostics, vaccine candidates, and effective treatments (see also below). this entails a significant recurring budgetary commitment. political and economic viewpoints that such costs are not cost-effective are fundamentally flawed because they generally only take into account the immediate cost elements, not the potential overall cost of the crisis and all its knock-on effects. these are being brutally revealed by the unfolding sars-cov- outbreak which, at this still early stage, is involving governmental support of national economies amounting collectively to trillions of dollars. and this is only the tip of the economic iceberg. bankruptcies, loss of employment, recession, loss of tax revenues, large scale deterioration of existing medical conditions in populations, potentially wide-scale deterioration of mental health, and so forth, and the economic costs of these, also need to be taken into account when reflecting on the cost of the contingency planning insurance policy. as an illustration of knock-on effects, global economic estimates of the benefits of vaccination have also shown that they extend well beyond those estimated from prevention of the specific disease in vaccinated individuals (bloom, ) . it is also worth comparing crisis preparedness costs with military expenditures. the latter are indeed budgetary commitments for preparedness for another type of crisis, namely a military conflict (excepting countries that use their military for internal affairs). and, as is the case in epi/pandemic preparedness, a considerable fraction of military resources is dedicated to surveillance operations. while accepting that military expenditures are also justified in terms of deterrence of hostile actions, and a multitude of non-combat roles armed forces may undertake, it is not self-evident that future military conflicts may result in losses of life and economic damage as high as the current covid- pandemic. in any case, in terms of protecting citizens, it should be abundantly clear that effective contingency preparedness for pandemics, and other crises, should be equated with military preparedness, and budgeted accordingly. • the principle of citizen protection demands that governments budget for adequate crisis preparedness in the same way that they budget for military preparedness. it is simply one of several essential 'insurance premiums' to which the state must commit. from earlier infectious disease outbreaks, we can assume that the most probable source of a new pandemic will be an animal virus, probably a coronavirus, whose natural host is a wild animal, possibly a bat (e.g., see brüssow, ) , that mutates and, as a result, becomes infectious for humans, or for an intermediate host, from which it subsequently jumps to humans. close contacts between humans and the animal host provide the opportunities for transmission. reducing such close contacts will reduce the probability of spillover and thus of an outbreak. close contacts between wild animals and humans occur in wet markets in asia, small-scale mixed farming activities with ducks and pigs, and so forth, or when humans encroach into wildlife habitats, e.g., through ecotourism, or destroy wildlife habitats for economic activities, forcing wildlife to enter human habitats (e.g., the destruction of rainforest for palm oil cultivation appears to have catalyzed a nipah virus outbreak; brüssow, ) . in any case, although pathogen:host interactions underlying disease are generally well studied, current knowledge about the ecology of infectious agentswhere pathogens are and what they are doing prior to infection of humans, especially those having alternative hosts, and how they are circulating and evolving new pathogenic and host-range potentialis inadequate. in order to transit from response mode to pro-active ecological measures to prevent outbreaks from occurring, there needs to be a major research effort to obtain a fundamental understanding of pathogen ecology (see e.g. timmis, ) . • greater efforts are needed to reduce human:wildlife contacts and habitat overlaps, in order to decrease the probability of viral pandemics • effective outbreak prevention measures require acquisition of fundamental knowledge about pathogen ecology contingency planning and the public memory. it is human nature that, once this crisis is over, people, except those who lost loved ones, employment, and so forth, will generally want to forget it as quickly as possible and get back to normal. the number of individuals who try to keep it in the forefront of memory, in order to institute new measures that adequately protect us from the next crisis, and there will undoubtedly be new crises (see above), will be few and far between. some, not all, leading politicians who now (often for the first time) insist that their responses are being guided by the best scientific evidence and advice, as though it were the most natural thing in the world, will quietly shed themselves of their scientific credentials and revert to business as usual, even when unpleasant issues like global warming, the antibiotic resistance crisis, our vulnerability to terrorist and cyber-attacks, again come to the fore. in order that our collective memory retains the crucial need for crisis preparedness, it is essential that each year governments publish updated and independently audited contingency plans. literacy. and the public-the central stakeholders in, and funders of, government policy/actions-must be able to understand the issues and personally evaluate the sometimes vague policy statements they hear. to do this, society must become knowledgeable about/literate in such things. in the case of infectious disease crises, such as the one currently ravaging humanity, and the contingency plans necessary for these, literacy in relevant microbiology topics is, as we have previously argued, essential (timmis et al., ) . interrupting the transmission chain in a pandemic may require lock-down, which imposes major personal sacrifices on the public, including confinement: loss of freedom of movement/social activities/family visits; closure of workplaces/loss of employment and income, resulting in economic hardship/increases in debt; closure of schools/ places of worship/hospitality venues/fitness studios/clubs of all sorts; restrictions on shopping; and elevated stress/ worsening of psychiatric conditions. it is, therefore, crucial that such measures are accepted and supported by the public. for this, people must be engaged and presented with coherent lock-down plans that are convincingly justified, in order to solicit compliance, solidarity and sharing of responsibilities. federal structures, like those in the usa, germany and switzerland may lead to uncoordinated actions in different parts of the country that are unsettling and unconvincing, because the public perceives them as arbitrary. such countries require coherent national plans that are consistent for the entire country. of course, all people in lock-down want an exit as soon as possible, and it is essential for governments to develop and communicate as soon as possible their exit strategy, and the determining parameters and assumptions upon which it is based. interestingly, some members of the public favour staggered exit plans, which implies a willingness to accept an infection risk. it will, therefore, be important for the government to have a public discussion on different risk scenarios, to obtain, present and discuss human/economic cost:benefit estimates (e.g., human lives against cost in loss of income /economic prosperity underlying the lock-down versus herd immunity approach-how much unemployment averts how many deaths or years of productive life when considering the age structure of death). and this discussion needs to take place in the context of the probabilities of loss of life through other adverse causes, such as annual influenza epidemics. family-friend contacts with terminally ill patients. one of the most shocking aspects of the covid- pandemic is the daily reporting of relatives of terminally ill patients who are unable to be with their loved ones at the end, and to pay last respects before burial. while this may be understandable in the context of patient isolation, social distancing, and the unbelievable hectic in overwhelmed icus, serious effort should be made to find a solution, perhaps moving terminally ill patients to an environment that permits both end-of-life patient care and limited safe contact with loved ones. • governments must publish annual audited overviews of the national state of crisis preparedness, with critical analyses of its strengths and weaknesses and plans to address the weaknesses • governments and education ministries must raise public awareness of crisis potential and promote understanding of key elements of crisis management, inter alia through investing in school curricula changes and public information campaigns that increase literacy in topics such as microbiology and public health • governments should involve civil society in discussing restrictive measures because this increases compliance and the solidarity to shoulder the consequences. achievement of optimal preparedness for, and operational responses to, a pandemic demands two things: international benchmarking and transparency/accountability in health systems (and of those who regulate and finance them). this includes chains of command and shared administrative responsibilities, procurement services, reliance on external suppliers of essential materials, and so forth. the disparities in responses we have listed above, that demonstrate significant differences between countries in the ability to respond to pandemics, are not justifiable in terms of operational efficiency, protection of frontline professionals, clinical outcome, and so forth, and cannot be allowed to persist, to be manifested again in future crises. health systems worldwide largely operate within narrow national perspectives, with little interest in better systems elsewhere. we urgently need objective and transparent benchmarking, and automatic mandating of adoption of the best practices in the world, where feasible. transparency and convincing justification for failure to adopt the benchmark must become the norm. of course, different health systems operate in different frameworks-payers, insurance, authorization and recommendation agencies, and so forth-but the tail cannot be allowed to wag the dog. existing frameworks can no longer be accepted as default excuses not to improve. they must be adapted to allow adoption of the benchmarks, where possible, not the other way round. in the final analysis, there are only two elements relevant: the person in the icu, who pays tax/insurance, and hence for the health system, and the government, which is responsible for health system functioning/evolution and protection of its citizens. both of their goals are in principle aligned, so there should be no controversy: provision of the best achievable health system that is adequately prepared for catastrophic pandemics. • governments and health systems must subject national health systems, and national health system crisis preparedness, to international benchmark scrutiny, and transparently strive for attainment of best international standards. it is the responsibility of government to protect its citizens and the role of industry to innovate and create commercial products and services. these two goals are not always aligned for current clinical exigences. but to provide a vital health system, government and industry must align and form alliances that create synergies. there are, of course, many successful examples of such beneficial alliances. however, there is sometimes an unrealistic perception of the role of industry, particularly by some governments when confronted with a crisis for which they are not prepared, as articulated in the generic cry: why do not we have a vaccine for this, why do not we have a drug for that? for example, regulatory and payment hurdles incentivize industry to develop cancer drugs rather than antimicrobials, so it is irrational and unwarranted to complain about the poor state of pipelines for new antivirals in the time of covid- , of antimicrobials in the time of the antimicrobial resistance crisis. if industry is to realign its research priorities towards current clinical priorities, it needs incentives to do so, e.g., through adequately funded creative governmentindustry-academia-clinical-regulatory strategic alliances. we have previously proposed a mechanism to create novel pipelines for accelerated discovery of new drugs and diagnostics (timmis et al., ; and, simultaneously, to promote long-term revival of struggling economies, interestingly in response to a financial crisis-that of -which the sars-cov- pandemic will again unleash with considerable severity). this proposal calls for the use of infrastructure budgets (not overstretched research-education-health budgets) to be targeted to the creation of new strategic national/ regional alliances between (i) cell biology and microbial diversity research groups, to discover and develop new diagnostics, drug targets and assays, and new drug leads from new microbes, (ii) biochemical engineers, chemists and pharma, to produce, evaluate and develop drug candidates, (iii) pharma, clinical research and regulatory agencies to assess clinical efficacy and safety of, and develop new drug candidates. in the context of the sars-cov- pandemic, an alliance between virology, cell biology, microbial diversity, and synthetic microbiology groups in upstream discovery would accelerate new antiviral discovery and populate antiviral drug pipelines, but also pipelines of new antimicrobials urgently needed for the treatment of bacterial superinfections responsible for some of the covid- mortalities. and: while advanced age, underlying co-morbidities and infection dose are identified as predisposing factors for development of severe covid- disease, deaths among young healthy individuals also occur for reasons currently unknown. once predisposing factors for this group have been elucidated, diagnostics to identify young people at risk, especially those most exposed to sars-cov- , will be needed in order to reduce their exposure. vaccines, despite their proven value in protecting against disease and their much-heralded pivotal importance for lockdown exit and herd immunity, are the cinderellas of clinical practice and, in normal times, not only attract little interest from governments but also are controversial, due to negative publicity from vociferous anti-vaccine groups propagating unfounded claims. the development and use of a number of current vaccines/vaccine candidates are orchestrated and funded, not by industry and public health systems, but by philanthropic organizations, like the gates foundation, working with agencies like cepi (coalition for epidemic preparedness innovations) and gavi (global alliance for vaccines and immunizations). indeed, the gates foundation is also playing a leading role in the search for, and development of, a vaccine against covid- (https://www.gatesfoundation.org/ media-center/press-releases/ / /bill-and-melinda-gates-foundation-dedicates-additional-funding-to-the-novel-coronavirus-response). however, it is the duty of national governments and international organizations, as part of their pandemic preparedness, to finance vaccine development platforms that are able to rapidly create new vaccines in response to an outbreak. once a new vaccine candidate is shown to be safe and protective, its rapid large-scale production and distribution requires the infrastructure of large pharmaceutical companies. as epidemics cannot be planned, industrial managers cannot be expected to promote projects without a market. governments must therefore intervene to maintain the interest and technical capacity of industry in developing vaccines and antibiotics (a smouldering fire) by creating a market in form of governmental orders. assessments of value-for-money of these strategic alliances must be made in the context of the global costs of pandemics like that of sars-cov- . • pandemic preparedness requires rapid creation, production and distribution of effective materials for diagnosis, prophylaxis and therapy. this necessitates significant long-term investment in research and development involving unconventional alliances of disparate academic science and medical research groups, industry, philanthropic foundations, vaccine enabling coalitions, and crisis preparedness taskforces. there is great diversity in stress resilience (e.g., the ability to deal with peaks of illness) of different health systems, with some being at least regionally overwhelmed during the winter influenza season. the less resilient systems will generally be the first to become overwhelmed in a health crisis. while there are numerous parameters involved in health system resilience, and experts know most of the pinch points and solutions that can deal with these (but also what is uncertain and what needs to be understood before effective 'solutions' can be formulated), three elements worth consideration in efforts to increase health system resilience are discussed here. healthcare systems are by and large extremely large, complex, heavily bureaucratic and fragmented. the often system-wide, multi-level consultations, decisions and responses needed in times of emergencies are challenging and often slow, usually slower than crisis development, which means that healthcare systems follow and react to events, rather than managing them. crises are in some ways analogous to wars, and bureaucracies are not designed to manage wars, which is the job of the military. in crises, we need crisis strategy-tactics specialists, a taskforce with short, well defined and effective chains of command, tasked with overriding normal procedures and taking charge of supply chains and requisitioning of assets, (re)deployment of personnel, organization and prioritization of allocation of infrastructure, managing logistics, and so forth. these could be specially trained taskforces of existing staff within healthcare systems, external taskforces or combinations of both. of course, for taskforces to operate optimally, they, together with the best available scientific minds, must also plan in advance the required resources, supply chains, personnel, strategic options, and so forth. they must also organize regular 'infection games'/public health manoeurvres (https://www.ted.com/talks/bill_gates_the_ next_outbreak_we_re_not_ready?language=en) = crisis 'fire drills', to train nationally and transnationally, refresh skills and explore and anticipate unexpected events to ensure preparedness, so that appropriate responses can be rolled out rapidly anywhere, independently of national borders. another, mandatory, task for the taskforce would be to conduct regular 'stress tests' of healthcare system resilience, as have been instituted for banks to ensure that they have adequate resources (= resilience) to withstand crises. such stress tests should be designed by health experts, epidemiologists-modellers, procurement agencies, representatives of the diagnostics-vaccine-drug industry, and so forth, and the design and implementation of the stress tests overseen by the taskforce. • national crisis task forces consisting of dedicated strategy-tactics specialists need to be established to plan crisis preparedness, make recommendations to improve health system resilience, and carry out regular crisis "fire drills" and stress tests. an important aspect of the sars-cov- outbreak is that, in most countries, it has become more difficult to obtain consultations with primary healthcare clinics/physicians, because of social distancing practices, illness or involvement in crisis management (e.g., see keesara et al., ) . as time goes on, the inability to access many primary healthcare services leads to progressive worsening of existing and new conditions in some individuals. access to primary healthcare, which in some countries was already unsatisfactory before covid- , is becoming a new crisis. this has resulted in the 'flight to the web' for information (sometimes obtaining disinformation in the process): the web is becoming a substitute for clinical consultations, in terms of obtaining information relating to symptoms experienced. this will ultimately have a significant impact on how the public views the computer as a facilitator-mediator of primary healthcare. while classical telemedicine-the ad hoc consultation of a remote, unknown physician who can advise on the symptoms presented-may be helpful in times of inadequate access to regular primary healthcare facilities, it cannot replace clinical advice informed by patient case histories and personal knowledge of the patient. reduced access to primary healthcare below a certain threshold constitutes itself a significant health hazard and is counter to a government's duty to protect its citizens. what to do to increase resilience of primary health care and increase access? one important contribution will be the 'digital healthcare revolution' (keesara et al., ) , i.e., some traditional one-on-one meetings between patient and doctor being replaced by web-based consultations. but also imagine teleconsultations based on (i) complete personal case histories, combined with (ii) up-to-date population epidemiological information, combined with (iii) individual patient best practice recommendations based on precision medicine analyses/predictions: welcome to the national clinical informatics centre (ncic; timmis and timmis, ) , informing in real time a virtual doctor, a clinically-programed, ai-evolving server. this doctor, interfacing with both the patient and ncic, diagnoses according to detailed case history and patient symptom input via computer (and aided, where necessary, by diagnostic information obtained through in-home patient self-diagnosis with apparatus/diagnostic materials promptly delivered by a medical logistics service), and makes treatment recommendations (timmis, ) . in some countries/regions, access to primary healthcare already involves significant waiting periods. the additional restrictions on access to primary healthcare resulting from the sars-cov- outbreak are resulting in further suffering and frustration that will surely make the prospect of a consultation with a virtual doctor providing personalized medicine, who is instantly available / , an increasingly attractive future possibility. of course, many health issues cannot be handled remotely via the web (though the proportion will increase steadily with the development of informatic infrastructure and easy-to-use home diagnostics), and will result in referral to a clinician. but, web-based consultations can significantly reduce numbers of patients requiring clinician consultations and the associated stress on the health system. • it is essential that health systems urgently develop centralized, secure informatic infrastructure needed to underpin web-based machine learning-facilitated precision medicine, and evolve web-based consultations, available on demand / , as an integral mainstream component of primary healthcare services. the current sars-cov- outbreak has brutally exposed the current vulnerability of society to pandemics, even those that have been long predicted and anticipated (ge et al., ; menachery et al., ) . most healthcare systems have not evolved for resilience in times of catastrophe, nor for effective rapid responses to pandemics. a key principle steering evolution has been value-for-money within a fixed budget; contingency planning within this framework (outlays for materials that may never be used) may be considered to be a nuisance that diminishes what can otherwise be done with limited funds, and so to a greater or lesser extent may be postponed. for this reason, it is crucial that budgets for contingency planning are separate from health system budgets. equally important, it has emphasized the fact that some healthcare systems have for a long time been on the edge of the cliff, just waiting for an event to push them over. their adaptation to changing needs has often been through a 'sticking plaster' response. evolution has been ad hoc, via responses to new developments and challenges, and often led to fragmentation rather than coherence. the lessons to be learned are thus not only to take scientifically-founded pandemic predictions seriously into account in policy elaboration, but also to streamline and institute changes in healthcare systems that impose an evolutionary trajectory that increases coherence, efficiency and preparedness, and the necessary mechanisms to maintain these as new exigencies arise (e.g., see timmis and timmis, ) . and, especially because this crisis has revealed enormous disparities in responsiveness, effectiveness and the quality of responses in different countries, both preparedness for pandemics and the general improvement of healthcare mandate international benchmarking for contingency planning and the evolution of healthcare systems. comparisons/benchmarking within countries-within single systems-is no longer acceptable. many healthcare systems need substantive improvements through strategic investments, in most cases targeted to system changes, not just extra funding of existing services. and above all, they need crisis taskforces embedded in them that can prepare for, and take charge in times of, impending catastrophes. another lesson learned is that the sars-cov- outbreak has revealed new synergy potentials, such as the manufacture of ventilators by engineering companies not normally active in the manufacture of medical devices. it is not unreasonable to assume that new innovations can and will emerge from new interactions between creative engineers and clinicians. for example, best practice for breathing difficulty and poor blood oxygenation is intubation and ventilation. the paucity of ventilators is a 'critical control point' for best treatment practice in some hospitals, which has been discussed above. anecdotal evidence suggests that, of those individuals who die, despite best treatment practice involving intubation, the cause of death is often due to superinfection by antibiotic resistant bacteria (vincent et al., ) . the cause of this may indeed be intubation, causing perturbation of normal lung physiology and creating susceptibility to superinfection. there are, however, less invasive means of increasing blood oxygen levels. perhaps engineers, together with clinicians, will devise new or improved non-invasive approaches to blood oxygenation. and once creative engineers from the non-medical field start to expertly scrutinize current medical devices, perhaps we will see new approaches and new designs that significantly advance medical practice. but perhaps the most important lesson learned is about our frontline health professionals ministering to covid- patients, especially those with severe disease. these clinicians and nurses who willingly and selflessly work long, sometimes multiple shifts to the point of utter exhaustion, often not able to see their families for long periods because of the danger of infecting them, always under unbelievable stress working in what are essentially war zones with the accompanying horrors (e.g. see http:// www.sixthtone.com/news/ /i-spent-seven-weeksin-a-wuhan-icu.-heres-what-i-learned?utm_source=sfmc& utm_medium=email&utm_campaign= _agenda_ weekly- april &utm_term=&emailtype=newsletter), sometimes without adequate protective clothing and always in danger of contracting covid- , sometimes becoming infected, and sometimes paying the ultimate price. these are the heroes of the pandemic, the faces of resilience of covid- healthcare, exceptional citizens demonstrating exceptional fortitude, personal sacrifice and professional dedication: they are our role models of the st century. real estimates of mortality following covid- infection valuing vaccines: deficiencies and remedies on viruses, bats and men: a natural history of food-borne viral infections the novel coronavirus-a snapshot of current knowledge fangcang shelter hospitals: a novel concept for responding to public health emergencies isolation and characterisation of a bat sars-like coronavirus that uses the ace receptor offline: covid- and the nhs: "a national scandal preparing intensive care for the next pandemic influenza health security capacities in the context of covid- outbreak: an analysis of international health regulations annual report data from countries covid- and health care's digital revolution a sars-like cluster of circulating bat coronaviruses shows potential for human emergence estimating case fatality rates of covid- the diy digital medical centre biological land mines: bioterrorism underscores major knowledge deficits in the ecology of infectious agents the home clinic or all in a day's work of dr the urgent need for microbiology literacy in society pipelines for new chemicals: a strategy to create new value chains and stimulate innovation-based economic revival in southern european countries the sars case study. an alarm clock prevalence and outcomes of infection among patients in intensive care units in characteristics of and important lessons from the coronavirus disease (covid- ) outbreak in china combatting covid- -the role of robotics in managing public health and infectious diseases key: cord- - gy nkhb authors: fielding, jonathan e. title: public health in big cities: looking back, looking forward date: - - journal: j public health manag pract doi: . /phh. sha: doc_id: cord_uid: gy nkhb this commentary provides reflections of a public health official on the important role public health departments play in advancing the goals of the larger public health enterprise in big cities, counties, and large metropolitan areas. persuading others that public health makes a contribution distinct from that of medical services has not always been simple. fast forward to . after a year of consulting on how to improve governmental public health in los angeles county and collaborating with other public health experts to develop many recommendations that were adopted by the county governing body, i accepted the job as county director of public health. public health was housed within the larger county department of health services and constituted a small portion of its workforce and budget. public health issues and concerns were often overshadowed by constant crises in health services financing and quality of care. these uniformly took precedence over public health's efforts to hire new staff and to strengthen internal capacity in areas such as chronic disease control, environmental health, and analytics. a high-profile breakdown in public health protection that occurred shortly after my arrival helped raise public health's profile. local news channel kcbs-tv aired an investigative report that used hidden cameras to reveal egregious food safety violations in los angeles restaurants, attracting considerable media attention and provoking public outcry. the news coverage inspired strong public support for holding restaurants more accountable for food safety. a visible restaurant grading system, previously unfeasible due to almost certain opposition by the politically strong restaurant association, was now possible. we were able to develop a system that both changed the incentives for retail food establishments and protected the public's health. restaurant letter grades (a, b, c), prominently posted at the entrance of all food establishments, quickly became an identifiable trademark of public health. these simple letter grades helped establish a public health "brand" and distinguished the field from the direct delivery of health care services. this event also illustrated the importance of our ability to respond rapidly to public health needs. indeed, being nimble and politically sensitive are important keys to advancing public health programs, whether for health protection, disease prevention, or health promotion. it took years and extensive effort by both internal and external partners to convince the county board of supervisors, comprising democrats and republicans, that public health should be its own department. with close to employees and programs, how could public health operate effectively as part of a parent organization with a different mission? we were gratified when the board of supervisors in voted to officially create a separate department with a mission to protect and improve the health of all million residents. for me, the realization of this goal was the most important of my tenure in los angeles. the new department asserted public health's independent legitimacy and promoted its visibility. the department's independence also gave us direct access to the county senior administrative leadership and to the board of supervisors, allowing us to argue directly for the resources, programs, and policies we needed to fulfill our mission. finally, the vote to create a new, independent department elevated our strategic goals and made it easier for us to work with other county departments to improve our responsiveness to existing and emerging public health concerns and move forward with other critical activities. raising public health's visibility has meant, in one aspect, to be literally visible. for me, it was important for public health to have a face, and that the face was the health officer, who under state law had broad responsibility and authority. i believe that in every community, health officers should be seen as the leader responsible for protecting human health. in the role of health officer, i've made many media appearances focused on educating the public about current health issues and teaching people how to better protect themselves from infectious and chronic diseases, environmental hazards, and other health threats. visibility has also meant increasing the department's presence at the state and national levels. the involvement of local health officers at state and national levels is critical because they give authoritative voice to health problems at local levels, from environmental threats to substance abuse to food. such local-level problems are often difficult to address due to barriers embedded in state and federal laws or regulations. developing internal capacity is an ongoing process, the centerpiece of which has been hiring strong staff with good leadership skills. we have been fortunate to attract a cadre of experienced, mission-driven public health professionals to lead our programs. in addition, we are fortunate to be in a large metropolitan area with many excellent colleges and universities. to tap this talent pool, we created internship programs for students and now recruit both locally and nationally. through this program, we have been able to identify, recruit, and train a wide range of talented individuals who eventually get hired as permanent employees. with strong staff and a prominent public presence, our department has charted a course definitively distinct from that of health services. we have focused on opportunities for health promotion and worked to anticipate and prepare for emerging threats. beginning after the september , , attacks and continuing through the anthrax scare, severe acute respiratory syndrome, pandemic h n , bird flu, and middle east respiratory syndrome, the department has recognized and embraced its pivotal role as a public safety agency. we have modeled how to be an ally in counterterrorism efforts, helping draft a memorandum of understanding with the fbi and staff the joint regional intelligence center, a cooperative effort to centralize federal, state, and local activities related to responding to suspected terrorist threats. these cooperative activities have become a priority as we anticipate emerging threats-including terrorism-and proactively position ourselves to respond. in endeavoring to make many of these changes, i faced both criticism and controversy. i have been criticized for advocating for a visible role for public health on controversial issues such as limiting the marketing of sugar-sweetened beverages to children and for advocating that menus of fast food restaurants list calories and composition of their items. i have also been criticized for allocating too few or too many resources to a particular health problem or to or more racial groups or geopolitical units and for not being sensitive enough to the concerns of the organizations we regulate. if you are committed to a proactive health-promoting agenda, you cannot avoid criticism. while a public health perspective or warning may not always be welcome or palatable, it is only by consistently basing policy recommendations and decisions on the best science that the department has become a respected resource for elected officials. in , tom frieden, who then directed the new york city public health department, and i organized the big cities health coalition (bchc), based on the concept that urban centers share unique opportunities and challenges. the bchc includes of the largest local public health departments in the united states and is focused on building partnerships, exchanging ideas and best practices, and facilitating program and policy development by member departments. just as i have focused locally on establishing my department in los angeles as the local voice of reliable health information and data, an important role for the bchc is to identify and analyze the best science and collectively advocate for policies and programs that can improve health at the population level. to be an effective advocate for public health in big cities, the bchc needs to be the "go-to" resource for questions from legislators on health-relevant policy and programmatic issues. public health departments in large metropolitan areas such as los angeles county play a very important role in advancing the goals of the larger public health enterprise. as local entities, they operate on the forefront of the most current issues. furthermore, as large departments, they are relatively resource-rich in comparison with other counties. as such, large metropolitan area public health departments are often the first to recognize and develop strategies to address the most burning issues of the day. big cities and counties thus have the opportunity and responsibility to provide leadership for the broader public health community, and the health officer is in the best position to communicate how to effectively meet both continuing and new challenges. coalitions such as the bchc are critical players in addressing the challenges of the st century including climate change, water scarcity, and novel environmental threats. such collaborations must take place not just with other public health departments but also with other local governmental and private agencies, legislators, and the public. collaboration with different sectors is essential because society can only develop healthy environments through collaborative efforts of public health with others such as regional planning, mental health, public works, parks and recreation, fire, and law enforcement. the department has encouraged the cities in our large county to make health a central consideration in planning decisions, an effort that led to the development of a comprehensive chapter on health and wellness in the city of los angeles general plan and similar health elements in the general plans of several other cities. our work with the city of los angeles highlights the importance of support and vision from elected of-ficials; we worked closely with local agencies on the development of the health and wellness chapter, as well as on other health-promoting initiatives. a specific example of collaborative planning is that we have made significant progress in transforming many los angeles neighborhoods to become more walkable and bikeable through strategic partnerships with other county agencies, local businesses, and community groups. these efforts, among others, have led to the recent recognition of los angeles as a bike-friendly community for the first time in after being referred to as "an almost pathologically bike-unfriendly city" by slate magazine in years prior. working with elected officials requires sensitivities to their political needs and priorities. most elected officials, whether in the executive or legislative branch of government, face reelection every to years. compare this time horizon with those of public health initiatives such as those focused on reducing the rate of obesity, reducing the toll of combustible cigarettes, or reducing exposure to environmental carcinogens. making changes that will impact these health problems can take decades to show results. meeting both public health and political goals requires a balanced portfolio of programs and policies that includes those with a rapid political return to help politicians demonstrate progress aligned with the election cycle. for changes with long-term outcomes, public health officials must mobilize allies who can help convince politicians of the long-term benefits. public health's fundamental challenge is convincing the american people that their health, individually and collectively, is primarily determined by the social, physical, and economic environments in which we live. while the relative contribution of different environments to health is debated, a commonly used allocation for its contribution to health outcomes is between % and %. the public must also accept that health care, while important, cannot remedy many of our country's current health problems or improve our poor ranking in health status and key measures compared with other developed nations. currently, the united states is ranked th in life expectancy and st in infant mortality out of countries by the organisation for economic co-operation and development. to date, we have not yet succeeded in getting the layperson to grasp this critical issue. when asked to name the most important thing that can be done to improve health in los angeles county, my response is, "that's easy: increase the high school graduation rate." this response frequently elicits a blank look. people often do not understand the interconnection of education and health outcomes until they engage in discussions about income and literacy, and how these factors are related to health and longevity. copyright © lippincott williams & wilkins. unauthorized reproduction of this article is prohibited. we must continue to initiate these discussions in the public sphere until these interconnections are universally understood and are the basis for political actions. it has been a privilege to be the health officer and director of the los angeles county department of public health for the past years. as i leave the directorship to my successor, i look forward to returning to the school of public health at the university of california, los angeles, to train and mentor future public health leaders. it is to this new generation of professionals that we pass on our important work. looking back at my time in county service and my previous experience as a state public health commissioner, a number of important lessons stand out. some have already been mentioned but merit repetition. r look carefully and extensively to find the best staff, both existing employees and new recruits. make sure they have the resources to succeed, encourage them to take risks, and back them up. r form coalitions with other sectors to support policies and resources that are wins for all concerned. r understand the landscape. in your professional role, assess each aspect in which your organization is ahead or behind. look to your peers to compare and contrast circumstances and opportunities, taking into consideration community health status, programming, and the policy and economic environment. consider how to best prioritize opportunities based on this assessment. r borrow and lend ideas, challenges, successes, and failures. as the saying goes, imitation is the sincerest form of flattery. what might be considered infringement in the private sector is ideal in the public sector. it is gratifying when other jurisdictions borrow from a policy or program that los angeles has implemented and make it their own. and we haven't hesitated to borrow innovations from other public health agencies. r practice humility. sometimes it is important to apologize, even for mistakes you may not believe you have made. the perceptions of your bosses can be as important as facts, and if they perceive that you've made a misstep, take responsibility. two principles have guided me in my leadership positions. first, focus on your passion, not your career. careers are rarely a progression of obvious next steps. in deciding whether to take advantage of a new job op-portunity, focus less on your career trajectory and more on whether new opportunities give you the chance to learn and grow. we're all in public health because of personal conviction. follow that conviction. the second principle is more difficult because it entails substantial short-term professional and financial risk. do your job like you don't need it, making clear that scientific evidence and adhering to core public health principles trump ideology and political expediency. in other words, act in the manner that benefits the entire population you serve and whose taxes support your position, not just those who appointed you and to whom you report. public health made considerable gains in the last century, making a significant contribution to the expansion of life expectancy in the united states by an eye-popping years. now, the scope of public health has evolved to include new threats, especially terrorism and climate change. what is most important for all of us is to realize that our vision of healthy people in healthy communities cannot be achieved without understanding that our social, physical, and economic environments are the major determinants of health. this concept is nowhere better appreciated than in our largest metropolitan areas, within which wide variations in social and built environments are mirrored by variations in health, disease burden, and mortality. and both alone and as part of coalitions from multiple sectors, big cities, counties, and metropolitan areas can be in a position to adopt effective initiatives that will improve those environments and make demonstrable progress toward health equity. top u.s. cities join the ranks of bicycle friendly communities nobody bikes in l.a. slate magazine preventing disease through healthy environments: towards an estimate of the environmental burden of disease. france: world health organization health at a glance health, united states key: cord- - nyzwb authors: das, nileswar; narnoli, shubham; kaur, apinderjit; sarkar, siddharth title: pandemic, panic, and psychiatrists - what should be done before, during, and after covid- ? date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: nyzwb nan since the world health organization (who) has declared coronavirus disease as a pandemic in january- , more than -countries have been affected with over million confirmed cases. although the part to be played by psychiatrists to pacify global panic in peri-pandemic period is not defined anywhere, psychiatrists should take a leadership role, both in crisis intervention, and long term mental health mentoring (tandon, ) . this is a time of uncertaintiesall individuals are uncertain about their health and economic outcomes. also, there is overwhelming misinformation, stigma, prolonged isolation, and disruption of daily routines. all these factors can impact one's psychological-wellbeing j o u r n a l p r e -p r o o f (brooks et al., ) . fear and anxiety had led to suicides, communal disharmony, and crimes against essential service providers (sharma et al., ) . not only individuals with confirmed or suspected covid- but several other vulnerable groups (e.g. health care workers, persons with mental illness etc.), despite remaining uninfected, will continue to suffer from psychological infirmity. therefore, we need an intervention plan to address mental-health problems during the pandemic (das, ) .  psychological preparednessto what is coming. it can help individuals to take stock of their coping and prepare them to deal effectively with stressful situations.  early detectionof psychiatric manifestations and distinguishing normal reactions to stresses from mental disorders.  psychiatric interventionto take care of psychological trauma following the pandemic. psychosocial/psychiatric rehabilitationcommunity reintegration.  performing researchesto generate an evidence base for formulating further course of action and policy-making. what are the possible roles to be played by psychiatrists during various phases of the pandemic?  public awarenessproviding the right health information is vital during this time of crisis -(i) to address hand hygiene and safe physical distancing, (ii) to reduce panic j o u r n a l p r e -p r o o f shopping and hoarding of medical equipment (e.g. masks, hand-sanitizer, antibiotics), (iii) to follow the national lockdown to avoid widespread community transmission, (iv) to maintain adequate mental and physical wellbeing and (v) misinformation restriction to avoid chaotic and stressed environments in the country (bhatia, ) , (sharma et al., ) . one possible solution could be reaching the common public through local leaders and influential celebrities using the same media.  homeless, immigrant and migrant crisisproviding shelter and food can mitigate the problem to some extent. but the huge psychological stress and possible future adversities remain to be addressed. providing adequate psychological support from others, including family members, by being in contact on the phone, along with the resources provided by the government, may be crucial to saving many lives.  medical preparednesslockdown is a relative measure to buy time for medical preparedness. establishing designated hospitals, provision of personal protective equipment and life-saving drugs are crucial but providing psychological support and trauma preparedness training to the emergency care providers can reduce their anxieties and significantly reduce the future psychological trauma in these work-groups (lai et al., ) .  resource allocation -during the pandemic, one of the important things that needs to be done is testing of suspected individuals, contact tracing and isolation of suspected cases. allocation of both man-power and fund to this needed activity would be necessary. mental health care providers here may also need to take up the role of a primary health care provider when needed and as per their training statutes.  psychological wellbeing of vulnerable groups -most vulnerable groups needs to be taken care of. we need to step-up in providing telepsychiatry consultation to the individuals who may not physically follow up for various reasons.  continued psychiatric follow up services -it is important to provide continued services to the previously registered mentally-ill patients to refill or adjust their medication without any need to visit hospital. this is particularly important both because lockdowns have made it difficult to travel, and continued social distancing practice can enforce hospitals to restrict number of non-emergency patient visits in coming future .  shutdowns, lockdowns, and forced quarantines -it is very likely to have prolonged lockdowns during pandemic progression. ensuring the supply of daily needs is one aspect, while at the same time, the real challenge would be maintaining one's psychological wellbeing. digital media can be used as a source to train individuals and promote the ways of (i) upholding a healthy lifestyle, (ii) maintaining a near-normal daily routine, (iii) relaxing exercises to deal with stress and, (iv) other ways of coping.  social distancing vs physical distancing -'social' distancing appears to be a misnomer in the present time. in this tough time, maintaining social contact with friends and families is very crucial while maintaining safe physical distancing (galea et al., ) . psychiatrists can promote social bonding through the use of telecommunications to minimize the loneliness in these already scary times. can lead to fear and anxiety, and may also lead to stigma. it is also important to 'avoid labelling' the affected individuals or community as 'victims'. it would be necessary to support emergency service providers and to stop spreading rumours. one should seek adequate help if someone is annoyed being identified with illness or being marginalized in society. studies have shown stigma to be directly associated with poor mental health outcomes in the long run (kane et al., ) .  disaster management -in the aftermath of covid- , the situation would be more similar to a natural disaster. with a high number of individuals being under stress, many may show signs of anxiety, depression, posttraumatic stress disorder, among many other psychological disturbances. economic difficulties consequent to the pandemic may also lead to an increase in rates of mental health problems, substance use disorders, and suicides. integration of mental health care with already existing public health services to provide basic psychological support may help to combat long term psychological adversities in the societies. the role of mental health care providers divided above into various phases of the pandemic may not follow the strict pattern and may overlap in reality. they also have to play usual role addressing the mental health of those admitted in in-patient, emergency or intensive care units (acute psychosis, acute mania, catatonia, suicide and delirium); role in breaking badnews and also the mental health providers themselves to keep their calm (avoid getting overwhelmed by the rise in mental morbidity). in summary, covid- is anything but only an infectious disease. various far-reaching psycho-socio-economic adversities will have serious mental health issues. psychiatrists and other mental health professionals need to step up, utilizing 'all-out' resources to prevent a post-covid- mental-illness pandemic. the authors do not have any conflicts of interest to report financial disclosure the present study was non-funded. the authors do not have financial disclosures public engagement is key for containing covid- pandemic the psychological impact of quarantine and how to reduce it: rapid review of the evidence psychiatrist in post-covid- era -are we prepared? the mental health consequences of covid- and physical distancing: the need for prevention and early intervention a scoping review of health-related stigma outcomes for highburden diseases in low-and middle-income countries factors associated with mental health outcomes among health care workers exposed to progression of mental health services during the covid- outbreak in china a chaotic and stressed environment for -ncov suspected, infected and other people in india: fear of mass destruction and causality the covid- pandemic, personal reflections on editorial responsibility none j o u r n a l p r e -p r o o f key: cord- -mehijkzo authors: guo, shuaijun; yu, xiaoming; okan, orkan title: moving health literacy research and practice towards a vision of equity, precision and transparency date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: mehijkzo over the past two decades, health literacy research has gained increasing attention in global health initiatives to reduce health disparities. while it is well-documented that health literacy is associated with health outcomes, most findings are generated from cross-sectional data. along with the increasing importance of health literacy in policy, there is a lack of specificity and transparency about how to improve health literacy in practice. in this study, we are calling for a shift of current research paradigms from judging health literacy levels towards observing how health literacy skills are developed over the life course and practised in the real world. this includes using a life-course approach, integrating the rationale of precision public health, applying open science practice, and promoting actionable knowledge translation strategies. we show how a greater appreciation for these paradigms promises to advance health literacy research and practice towards an equitable, precise, transparent, and actionable vision. health literacy underpins everyday health behaviours and health-related decisions. defined as an individual's ability to find, understand, and use health information to promote and maintain good health [ , ] , the term "health literacy" has been widely used in healthcare, disease prevention, and health promotion since the s [ ] . health literacy is a context-and content-specific concept; this means that researchers need to define and measure it within a specific context for a particular purpose [ ] . from a public health perspective, health literacy is regarded as a personal asset that evolves over the life course and promotes empowerment in health decision-making [ ] [ ] [ ] . in the context of the coronavirus disease of (covid- ) , an individual's health literacy supports his/her decisions on washing hands, maintaining physical distance, adopting protective behaviours, seeing a doctor, and complying with quarantine policies, thus contributing to a more likely successful public health response strategy [ ] [ ] [ ] . health literacy also helps to navigate the infodemic-the overabundance of valid and invalid information that is circulating on the internet-that is attached to the covid- pandemic [ , ] . low health literacy is a global public health concern. internationally, it is estimated that . % to . % of adults have low health literacy [ , ] , costing national governments at least $ billion annually [ ] . mounting evidence suggests that low health literacy is associated with adverse health outcomes [ ] [ ] [ ] , including frequent use of emergency care, prolonged hospital stays, and high mortality rates, which in turn lead to health disparities [ ] . national and international health programs have shown promising outcomes (e.g., improved health knowledge, healthier behaviours, self-management of chronic illness, access to healthcare) when intervening to improve health literacy [ ] [ ] [ ] . most recently, the world health organization's shanghai declaration on promoting health in the agenda for sustainable development highlighted health literacy as an integral part of the skills developed over a lifetime and recognized it as a critical driver of achieving an equitable world [ , ] . enhancing health literacy requires a systems approach to understanding its risk factors and its impact on health outcomes [ , , ] . the social determinants framework suggests that health literacy is an interactive product of an individual's health literacy skills and the broad environment and culture [ , ] . empirical studies show that health literacy levels differ substantially across age groups and countries. based on the demographic and health surveys, mcclintock et al. [ ] found that the prevalence of poor health literacy among respondents aged - years ranged from . % in namibia to . % in niger across sub-saharan countries. as for children and adolescents, the health behaviour in school-aged children study shows that, in countries (e.g., austria, england, finland), a total of . % of participants have low levels of health literacy, ranging from . % to . % across countries [ ] . there is a social gradient in health literacy for children [ ] , adolescents [ ] , and adults [ ] . the lower the socioeconomic status an individual has, the lower the health literacy level is likely to be. health literacy can affect health outcomes at each life stage. prior to childbirth, low health literacy in pregnant mothers has a significant impact on the health and development of their offspring, including prematurity, infancy death, and child vaccination participation [ ] . low health literacy in children and adolescents is associated with poor health behaviours, such as smoking, alcohol use, and obesity [ ] [ ] [ ] [ ] . when children and adolescents transit into adulthood and older age, health literacy is closely linked with healthcare outcomes, such as prolonged hospitalization and poor medication adherence [ , ] . while health literacy research has gained momentum in the global context [ , ] , it is predominated by cross-sectional studies, with less than % of all published papers focusing on health literacy interventions, including randomized controlled trials [ , ] . unlike time-series data, cross-sectional data make it impossible to make a valid statement regarding the change. health literacy is a life-course personal asset [ ] , which progresses as a child grows up with different characteristics and health needs at each life stage [ , ] . for instance, children's and adolescents' health literacy rely heavily on their developmental ability and their parents and peers [ ] . when they transition into adulthood, they become more independent in making their own decisions in healthcare, disease prevention, and health promotion [ ] . as cognitive function declines with age, older adults are an especially vulnerable group, with low self-management ability for everyday health-related decisions [ , , ] . currently, there is a lack of holistic ways to look at the impact of health literacy over the life-course due to a lack of longitudinal studies. there is promising evidence showing the effectiveness of health literacy interventions on health outcomes at the individual and community level [ , [ ] [ ] [ ] . however, there remain substantial gaps. in practice, health literacy interventions vary in terms of their study designs, measurement tools, and types of outcome measures [ , ] . besides, there is a lack of specificity in the intervention targets (e.g., individual level, organizational level, community level), content (e.g., functional health literacy, interactive health literacy, critical health literacy), timing (e.g., antenatal, preschool, adolescence), and formats (e.g., universal, intensive, low-threshold). it remains unclear about which interventions are the most effective in improving health literacy, related health behaviours, and associated health outcomes. when translating health literacy evidence into practice, researchers should design interventions that are specifically tailored to people with different health literacy levels and needs [ , ] . there is a need to use precise and transparent approaches to improving health literacy and reducing health inequities in the end. in response to low health literacy levels in the population, many countries have developed national action plans to strengthen health literacy for achieving sustainable development and health equity (e.g., the national actional plan to improve health literacy in the usa [ ] , the national statement on health literacy in australia [ ] , the national action plan health literacy in germany [ ] ). common features in these policy documents include a response to perceived deficiencies in health literacy, the importance of professional education in improving the quality of communication, and a need for responsive healthcare systems [ , ] . policy responses to health literacy are important public statements of priorities by governments and provide a mechanism for public accountability [ , ] . however, in contrast to the increasing number of evidence generated from empirical studies, discussions on the knowledge translation and implementation process are scarce. there remains a lack of specificity in the implementation process and monitoring systems for progress. this perspective is a proposition for four new research paradigms to address the aforementioned knowledge gaps, expecting to move health literacy research and practice towards an equitable, precise, transparent, and actionable vision. this includes using a life-course approach to health literacy [ ] , integrating the rationale of precision public health [ ] , applying open science practice [ ] , and promoting actionable knowledge translation strategies [ ] . in what follows, we will discuss the life-course approach to health literacy as a starting point, and then the necessity of integrating the rationale of precision public health. we are calling for a shift of current research paradigms from judging health literacy levels (low versus high) towards observing how health literacy skills are practised and developed over the life-course. based on these new paradigms, we expect a nuanced understanding of how health literacy develops over the life-course, how it influences health behaviour and decision-making, and thus how it informs specific interventional opportunities-especially in the early life stages across educational and healthcare settings-for a precise policy recommendation. we also highlight the importance of applying open science and considering knowledge translation strategies from the beginning of research planning to generate or replicate policy-relevant findings rapidly and cost-effectively across different cultural contexts, and thus facilitate the process of knowledge dissemination. we need to extend the current concept of "health literacy" from cross-sectional to longitudinal studies. health literacy is a personal asset that develops dynamically over time [ ] . a life-course approach to health literacy will assist researchers in discovering opportunities for optimizing health development and reducing health inequities, and explaining how health practices and policies can go beyond the avoidance of disease to the promotion of health at the early life stages [ , , ] . as shown in figure , we recognize potential intervention levers (both upstream and downstream) for giving all children the best start to life. a life-course approach to health literacy aligns with national and international health initiatives that aim to reduce inequities (e.g., the national action plan for children and young people in australia [ ] ). a life-course approach is well-recognized in public health research and practice to close the gap in health inequities [ , ] . using life-course data from the wisconsin longitudinal study - , clouston et al. [ ] found that life-course predictors of health literacy among older adults included parental educational attainment, and adolescent cognitive and non-cognitive skills. findings from this life-course analysis add to our understanding of how health literacy might change over time through adolescent cognitive and non-cognitive skills. depending on the research purpose and available data sources, researchers could also propose other specific research questions using one of the life-course models exemplified in table . for example, early life represents a sensitive period of health and development. exposure to stressors associated with disadvantages during this time can exert adverse effects on health over the life course [ ] . using the sensitive period model, researchers can examine and compare the effect of parental health literacy on children's health behaviours and health outcomes at different ages of children (e.g., pregnancy, infancy, toddler age). a life-course approach to health literacy (hl) and its impact on health and social outcomes. table . applying life-course models to health literacy research. the sensitive period model to examine timing effects in which exposures during sensitive periods of development have stronger effects on health, social, emotional, and cognitive development outcomes than they would have at other life stages [ ] . • to examine and compare the effect of parental health literacy during pregnancy and infancy on infant and child health outcomes. • to examine and compare the different timing effects of risk or protective factors (e.g., socioeconomic status) in early years on health literacy in later years. the accumulation model to examine the role of persistent advantage or disadvantage over time-in both specific life stages and over life stages-on health and development [ ] . • to examine the role of persistent advantage or disadvantage (e.g., socioeconomic status, ethnic minorities) on health literacy in a specific life stage and over the life course. to examine the effect of persistent high or low health literacy (e.g., using the growth-based trajectory modelling method) on health outcomes over the life course. the pathway model to examine the pathway effects whereby early experiences set in motion a chain of events that put individuals on paths differentiated by types and levels of exposures to social and biological factors [ ] . • to examine the mediating role of health literacy (e.g., adolescent health literacy) in the relationship between socioeconomic disadvantage and health outcomes. the social mobility model to examine the unique importance of social mobility in explaining the early-life and later-life socioeconomic status and health link [ ] . • to examine whether the effect of later-life exposure (e.g., socioeconomic status, immigration status) on health literacy is stronger than the effect of early-life exposure. we are entering an era of "big data" and "precision". big data has enabled extensive and specific research and trials of stratifying and segmenting populations at risk for a variety of health problems, including poor health literacy [ ] . in the field of big data and public health, machine learning is a fundamental component of data analytics that provides data-driven insights, decisions, and predictions [ , ] . machine learning techniques have been broadly adopted for researchers to answer a series of public health research questions (e.g., identifying leading dietary determinants in children [ ] , predicting the development of type diabetes [ ] ). using different machine learning approaches, researchers can also address health literacy research questions, such as identifying elderly people at high risk of low health literacy. particularly, the breadth of longitudinal data available in existing cohorts enables researchers to generate policy-relevant findings quickly [ ] . similar to the precision medicine initiative of providing the right treatment to the right patient at the right time [ ] , a precision public health approach to health literacy calls for harnessing the power of resourceful life-course data to inform the right intervention to the right population at the right time [ , ] . in the context of covid- [ ] , precision public health is particularly useful to design targeted interventions for populations by person, place, and time to promote better navigation of health care and disease prevention [ ] . if a population has a higher proportion of persons with low health literacy, public messages could be provided to educate persons on where to obtain trustworthy information and when to seek health professionals [ ] . integrating the rationale of precision public health aligns with the relation-and context-specific nature of health literacy [ , ] . currently, there is a lack of specificity to inform clear health literacy policy decisions [ ] . figure shows that there are substantial opportunities for researchers to generate specific recommendations between personal and social determinants and health literacy (i.e., upstream intervention levers), and between health literacy and health and social outcomes (i.e., downstream intervention levers). for example, the education sector is a critical platform for health literacy interventions, and education for health literacy is a fundamental process and outcome across the life course [ ] . precision evidence is needed, such as at which time point, at what dosage, and which delivery approach is likely to have the most significant impact on improving population health literacy and reducing health inequities. we need to identify precise policy levers (either upstream or downstream) and build an evidence base with sufficient specificity to generate actionable policy implications. open science refers to a range of practices that promote transparency, openness, and reproducibility in research [ ] . efforts to reproduce published findings have yielded a concerningly high failure rate (e.g., only % replicated in nature and science [ ] ) [ , ] . in response to concerns about this "reproducibility crisis", the open science practice has been increasingly recognized across disciplines [ ] . [ ] . however, in practice, null results are less frequently published than statistically significant results and are more likely to be inaccessible and lost in the "file drawer" [ ] . to reduce publication bias, we need to move the current evidence of health literacy from an era of "publish or perish" to "visible or vanish" [ ] . transparency, openness, and reproducibility are central principles of open science practice [ ] . examples of open science practice include a preregistered report, detailed analytic plan, and publicly shared coding via the open science framework (table ) [ , ] . a future vision for health literacy research is to increase its clarity, credibility, and transparency, which can help to provide reliable evidence that can serve as a basis for making decisions about clinical or population-health interventions [ ] . for example, the health literacy tool shed is an online, publicly accessible database of health literacy measures [ ] . currently, more than measurement tools are available. healthcare providers and researchers can search and select the most appropriate instrument according to a specific research purpose [ ] . adoption of open science practice in health literacy research is effective to replicate studies across different cultural contexts. it also provides researchers with a system structure in documenting their work and improving workflows, and offers a path to publication irrespective of the null conclusions [ , ] . knowledge translation is the exchange, synthesis, and ethically sound application of research findings within a complex set of interactions among researchers and knowledge users [ ] . while a number of knowledge translation frameworks has been developed for researchers [ ] , there is a well-known gap between research and practice [ , ] . it is estimated that it takes years for just % of medical research to be implemented [ , ] . this is the same case in the field of health literacy [ , ] . while the importance of health literacy is increasingly recognized in national and global health initiatives [ , , ] , there is still a long way to go when applying health literacy into current practice [ , ] . the evidence synthesis shows that, of the existing and developing health literacy policies in european regions, the main barriers influencing the successful implementation of health literacy policy include cultural barriers, budget restrictions, and the difficulty obtaining high-quality evidence. besides, there is also a lack of engagement in policy evaluation by the academic community [ ] . translating the best available research evidence into evidence-based practice and policy is a complex process which confronts multiple barriers at the individual, organizational, and political level [ ] . there has been a range of efforts to reduce these barriers. for example, the optimizing health literacy and access (ophelia) is a whole-of-system approach to developing and implementing health literacy research [ ] . this approach is widely accepted in high-income and low-and middle-income countries, and uses health literacy profiling and community engagement to create and implement health reforms, thus improving health and equity [ ] . the ophelia approach has also been adapted for different populations and contexts, such as the healthlit kids [ ] . another well-established whole-of-system approach is organizational health literacy, which is widespread in north america and europe [ ] . organizational health literacy is based on the assumption that health literacy is a relational concept in which not only individual skills must be addressed, as well as system-level complexities. this concept has also been used in the helit-schools project, interlinking the organizational health literacy as applied to the school setting with the who health-promoting school framework [ , ] . there are four main benefits if the above research paradigms are applied in current health literacy research and practice. first, we can monitor and evaluate population health literacy levels over time by implementing routine data collection. this allows us to look at health literacy levels among different age groups as well as vulnerable groups, such as those from different ethnic minorities, backgrounds, and migrants, children and young people, chronically ill, and older people. we can also examine the protective and risk factors of health literacy and its impact on health outcomes from a longer-term perspective, thus informing policy opportunities at the best time. second, we can investigate a specific research question about health literacy from a precision public health perspective. we can use modern epidemiological methods, such as causal inference to explore the ideal time point to intervene in low health literacy of a specific population [ , ] . when a randomized trial is not available, we can use the emulated target trial to investigate the causal effect of improving health literacy on a specific health outcome [ ] . a most valuable approach to better understanding real-life health literacy is to focus on ethnographic research exploring the social practices when health information and knowledge are the action focus [ ] [ ] [ ] . third, through the open science movement initiative, it is cost-effective and time-efficient to measure, collect, and analyze health literacy data via existing or linked datasets. for example, the covid health literacy consortium (covid-hl) is a timely project in the context of covid- [ , ] . covid-hl aims to establish a global network on digital health literacy and increase global awareness on health literacy as a critical tool to help protect from communicable diseases. this international platform makes it possible for a health literacy comparison across countries and enables collaborations and data access for researchers. further examples include the who action network on measuring population and organizational health literacy (m-pohl), which aims at the routine measurement of different types of health literacy in the european adult population [ ] . fourth, the knowledge translation and engagement process moves the generated health literacy evidence towards the real world. knowledge end-users, such as policymakers or parents of young children, can benefit from interaction with researchers through reflections on their own daily activities, enhanced health knowledge, and skills to protect health. researchers can also benefit as they gain a nuanced understanding of the practice and policy environment, and develop health literacy research questions that have real-world applicability and benefits [ ] . there are also several challenges. first, health literacy measurement is a complex phenomenon across the life stage, even at a particular time point. the assessment of health literacy varies depending on the setting, research purpose, and the scope of health literacy definitions [ , ] . given that different age groups have different characteristics and health needs, researchers may consider using a core measurement tool plus a variety of add-on modules that target varying age groups [ ] . eventually, this will also make the measurement much more complex and time-consuming. second, it is complicated for life-course data planning and analysis using modern epidemiological methods. dropouts, missing data, and other study deviations (e.g., low response rates) are a common occurrence in both population research and clinical studies [ ] . it is important to consider the power analysis strategies to estimate the sample size, thus enabling researchers to detect a significant effect of health literacy on the outcome of interest. researchers also need to consider critical questions commonly encountered in longitudinal data analysis, such as confounding bias, selection bias, measurement bias, and whether to include an interaction term in a parametric model [ ] . in this case, informed by expert knowledge, researchers can use the directed acyclic graph [ ] to visually represent the hypothesized causal pathway from health literacy to a specific health outcome. the lifecourse analysis plan template is another useful toolkit that can strengthen the quality of observational epidemiological studies [ ] . as for big data in public health, while it provides opportunities to make causality inferences based on chains of sequence, it also introduces challenges to machine learning, such as high data dimensionality, model scalability, and distributed computing [ ] . third, using open science practice in health literacy often requires more time and effort for archiving, documenting, quality controlling of codes, and data security [ ] . open science is changing how research and practice are conducted, and it takes time to consolidate in the mainstream [ ] . currently, the majority of open-source datasets do not adhere to data principles, such as being findable and accessible [ ] . besides, data access and sharing are recurring challenges attributed not only to privacy concerns, but also ambiguous data ownership and unaligned incentives [ ] . there is a need for researchers to adhere to principles of research partnership and data governance models to prevent the breaches of privacy that obstruct ethically justified data access. fourth, knowledge translation barriers are common in practice, especially in the context of covid- [ ] . for example, when disseminating health literacy information in a multi-cultural setting, how could we engage with culturally and linguistically diverse families for the first time and get them to understand the right information? along with challenges related to information overload and an ongoing infodemic [ , ] , researchers and policymakers should be aware of the main facilitators that drive successful health literacy policy implementation, such as intersectoral working, political leadership, and overcoming cultural barriers [ ] . in addition, specific knowledge translation plans are needed in advance when implementing relevant strategies in the real world [ , , ] . there remains much work to be conducted to understand how to implement health literacy evidence into practice. when applying the above paradigms into practice, researchers need to be aware that we are not calling for a "one size fits all" solution to fill the gaps in current research. instead, we are calling for a more equitable, precise, transparent, and actionable way to advance health literacy in research and practice. the four paradigms mentioned above cover a broad range of considerations, ranging from a theoretical approach for individual research to empirical studies generating information using big data for policymaking. researchers can integrate one or two into their research planning and implementation. for example, when a researcher is exploring personal experiences of health literacy at the micro levels, it is more suitable to consider using open science practice and knowledge translation strategies to enhance the rigour of reporting studies and disseminate research findings to a range of stakeholders. health literacy is a crucial driver to health equity. while the evidence base shows a significant impact of health literacy on health outcomes, we need to move this field towards an equitable, precise, transparent, and actionable vision. a life-course approach to health literacy will allow for a better understanding of the mechanisms linking health literacy to health outcomes. a precision public health rationale corresponds with the specific nature of health literacy, and will enable us to generate specific policy recommendations to improve population health. open science practice will assist with minimizing publication bias and motivating researchers to share resources to produce more reliable and cost-effective evidence. finally, actionable knowledge translation strategies will bridge the gap between the academic world and the real world, leading 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ganesh; karkal, ravichandra; bhargava, madhavi title: all’s not well with the “worried well”: understanding health anxiety due to covid- date: - - journal: j prev med hyg doi: . / - /jpmh . . . sha: doc_id: cord_uid: mhy nu e the novel corona virus (sars- cov ) pandemic has created an unprecedented public health problem and a mental health crisis looms ahead. the isolation, socio-economic disruption, uncertainty and fear of contagion have led to a spike of health anxiety in the general public. individuals with health anxiety may get dismissed as the “worried well” in this pandemic due to disruption of mental health services and inability of healthcare systems to understand the psychosocial factors in the background. education of general public, training of healthcare workers in cognitive behavioural model of health anxiety and timely referral to mental health professionals in severe cases is need of the hour. the novel corona virus (sars-cov ) which was first reported in wuhan, china has engulfed the world in fear [ ] world health organization declared the covid- as a pandemic on march , [ ] . many countries had nation-wide lockdown including india, halting most economic activity leading to unemployment, displacement of migrant workers and loss of livelihood. the pandemic has created an unprecedented public health problem and has overwhelmed healthcare systems globally [ ] . medical and research communities are still discovering the enigmatic covid- which manifests not only as acute respiratory illness but also with a wide variety of dermatological, neurological, cardiac, gastrointestinal, and ocular symptoms; and guidelines for prevention and treatment are evolving each day [ ] [ ] [ ] [ ] [ ] [ ] . the isolation, socioeconomic disruption, uncertainty and fear of contagion have led to a mental health crisis which is being acknowledged worldwide [ ] . individuals who are worried about infection with the virus may not get adequate care due to disruption of mental health services during the pandemic. the "worried well" are unwell too a term 'worried well' is often used for persons who are relatively healthy but consider themselves as affected or likely to be affected. in present pandemic these are the persons who test negative or may not fit into the definition of a 'suspect'. in addition to these individuals, patients with illness anxiety disorder, panic disorder, generalised anxiety disorder, depression, somatic symptom disorder, and obsessive compulsive disorder may not get access to mental health services. our medical training and biomedical model of disease approach is compounded by the burden of keeping abreast with newer technical guidelines. this leads to suboptimal attention to the psycho-social factors and patients being told, "it's all in your head". as a result vicious cycle consisting of poor patient satisfaction and doctor shopping is set-off and this itself be detrimental in the present pandemic situation. people in quarantine who are not equipped with self-care and coping strategies feel lonely, socially isolated and may find it difficult to handle the parallel 'infodemic' [ ] . this leads to poor sleep and nutrition, lack of exercise, substance abuse, excessive usage of internet, and social media [ ] [ ] [ ] . moreover, the images of body bags piling up in hospitals or news of death in their own district/ state are threatening stimuli which give rise to unpleasant emotions of fear and anxiety. the precariousness of the current scenario, isolation, unhealthy lifestyle and overload of ambiguous information leads to chronic stress. this may act as a trigger for health anxiety in susceptible individuals or may worsen pre-existing mental health conditions. in severe conditions extreme health anxiety can even drive a patient towards committing suicide. threat cues can activate the dysfunctional schemas which are irrational assumptions and beliefs from an earlier experience. once these schemas are activated every event and stimuli in the environment get coloured by these. some have schemas of being painfully aware, especially grief, even after death; and that they can tempt fate by thinking too positively. individuals may see 'worrying' in a positive light and believe it will prevent negative events from happening or ward off danger and end up evoking more negative scenarios in their mind. these schemas once activated can in turn lead to misinterpretations of bodily symptoms, negative thoughts, and anxiety [ ] . individuals may pay undue attention to ever growing list of symptoms of covid- , become hyper-vigilant to internal and external body processes and any benign bodily sensation may be perceived as a symptom. moreover, symptoms arising from stress, insomnia, withdrawal from alcohol, etc. may get ignored. the uncertainty surrounding the pathophysiology, incubation period, mode of infection, testing, and treatment of this novel illness is intolerable for such individuals [ , , ] . repeated worrying about how to not get infected and being more preoccupied with worries can reduce actual vigilance from the threat. patients may even start doubting the competency of the doctor and endanger the fragile therapeutic relationship brought on by repeated reassurance seeking behaviour. anxiety in turn leads to specific behaviours which are unhelpful and maintain the vicious cycle of health anxiety [ ] . they may even repeatedly search internet for information, examine bodily fluids such as sputum and faeces; measure temperature, pulse rate and blood pressure; or go for repeated medical consultations. some may develop avoidance behaviour and isolate themselves from family members, avoid revealing their symptoms to others, or even skip medical appointments fearing they might test positive for covid- or be put in quarantine. this can lead to safety behaviours of self-medication which can even harm if not in appropriate dose [ ] . pre-existing mental illness, poor experience with healthcare systems in past, childhood sexual abuse, familial conflicts, marital discord, and other environmental factors can make an individual susceptible to develop these cognitive distortions. certain personality factors such as perfectionism ("my body should not have any symptoms"), rigidity in thinking, neuroticism (predominant negative emotions), high harm avoidance (leading to unhelpful safety behaviours), and anxiety sensitivity (tendency to interpret anxiety symptoms as signals of catastrophic physical illness) may increase vulnerability of individuals [ ] . a fine balance is required between communicating public health response and stigma mitigation; and our experience in hiv has a lot to teach. education and awareness campaigns targeting general public using all possible channels of communication can break the chain of misinformation. stigma reduction strategies to reduce the clout of dread around individuals infected with the virus are need of the hour [ ] . all healthcare workers especially in triage areas and fever clinics should be trained about health anxiety. empathetic listening and attention to psycho-social factors may allay fears. people who are in quarantine should be given access to telecounseling services and timely referral to psychiatrists in case of severe health anxiety or suicidal ideation. selfcare strategies in general public, relaxation techniques such as breathing and muscle relaxation exercises should be offered to all people in quarantine. mindfulness meditation can help individuals to be more self-aware and accept their bodily sensations in a non-judgmental fashion. cognitive behavioural therapy (cbt) is useful psychotherapeutic option in which individuals are encouraged to journal their behaviours of checking for bodily sensations, searching health related information on internet and reassurance seeking behaviours. they are also trained to challenge their thoughts related to their health and made to generate alternative thoughts. with increased penetration of the internet, even in rural areas, internet based cbt for health anxiety can be rolled out on an accelerated basis with significant cost benefits [ ] . who who timeline -covid- who releases guidelines to help countries maintain essential health services during the covid- pandemic covid- pandemic and the skin -what should dermatologists know? neurologic manifestations of hospitalized patients with coronavirus disease covid- and the cardiovascular system covid- : gastrointestinal manifestations and potential fecal-oral transmission characteristics of ocular findings of patients with coronavirus disease (covid- pharmacologic treatments for coronavirus disease (covid- ): a review the psychological impact of quarantine and how to reduce it: rapid review of the evidence covid- ) "infodemic" and emerging issues through a data lens: the case of china lifestyle behaviours during the covid- -time to connect facebook addiction and loneliness in the post-graduate students of a university in southern india mental health problems and social media exposure during covid- outbreak understanding and treating health anxiety: a cognitivebehavioral approach covid- pandemic -a focused review for clinicians stability issues of rt-pcr testing of sars-cov- for hospitalized patients clinically diagnosed with covid- caution and clarity required in the use of chloroquine for covid- stigma reduction and provision of mental health services in the public health response to cov-id- internet-based cognitive-behavioural therapy for severe health anxiety: randomised controlled trial funding sources: this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. the authors declare no conflict of interest. gk wrote the cognitive behavioural model section, rk wrote introduction and edited the manuscript, mb gave suggestions for recommendations to manage health anxiety from public health perspective. key: cord- - x ann authors: harvey, ruth; mattiuzzo, giada; hassall, mark; sieberg, andrea; müller, marcel a.; drosten, christian; rigsby, peter; oxenford, christopher j. title: comparison of serologic assays for middle east respiratory syndrome coronavirus date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: x ann middle east respiratory syndrome coronavirus (mers-cov) was detected in humans in . since then, sporadic outbreaks with primary transmission through dromedary camels to humans and outbreaks in healthcare settings have shown that mers-cov continues to pose a threat to human health. several serologic assays for mers-cov have been developed globally. we describe a collaborative study to investigate the comparability of serologic assays for mers-cov and assess any benefit associated with the introduction of a standard reference reagent for mers-cov serology. our study findings indicate that, when possible, laboratories should use a testing algorithm including > tests to ensure correct diagnosis of mers-cov. we also demonstrate that the use of a reference reagent greatly improves the agreement between assays, enabling more consistent and therefore more meaningful comparisons between results. middle east respiratory syndrome coronavirus (mers-cov) was detected in humans in . since then, sporadic outbreaks with primary transmission through dromedary camels to humans and outbreaks in healthcare settings have shown that mers-cov continues to pose a threat to human health. several serologic assays for mers-cov have been developed globally. we describe a collaborative study to investigate the comparability of serologic assays for mers-cov and assess any benefit associated with the introduction of a standard reference reagent for mers-cov serology. our study findings indicate that, when possible, laboratories should use a testing algorithm including > tests to ensure correct diagnosis of mers-cov. we also demonstrate that the use of a reference reagent greatly improves the agreement between assays, enabling more consistent and therefore more meaningful comparisons between results. s ince the emergence of middle east respiratory syndrome coronavirus (mers-cov) in ( ), more than , laboratory-confirmed cases have been reported to the world health organization (who); approximately one third of these cases were fatal. a large proportion of mers-cov cases have been the result of human-to-human transmission in healthcare settings ( , ) ; outbreaks have occurred in several countries, with the largest outbreaks seen in saudi arabia, united arab emirates, and south korea ( ). dromedary camels are the putative reservoir hosts for mers-cov; they experience no or mild symptoms upon infection ( ) . primary infection can occur from dromedary camels to humans, and new cases with evidence of camel contact continue to occur sporadically ( ) . mers-cov is of the high-threat pathogens on the who research and development blueprint ( ) , a document that sets out a roadmap for research and development of diagnostics, preventive and therapeutic products for prevention, and early detection and response to these high-priority pathogens. the who roadmap for mers-cov lists several priority activities, including improved diagnostics and vaccines for humans and camels as well as basic and translational research ( ) . serologic assays are critical for the evaluation of the efficacy of new vaccines and patient treatment, as are diagnostic tools to confirm infections and perform serosurveillance. a variety of serologic assays have been developed globally, both commercially and in-house; however, there is no evidence supporting the quality of performance of these assays and their consistency with one another. participants at the who intercountry meeting on mers-cov in cairo, egypt, june - , , recognized this issue as a public health priority and called for a study to compare currently available serologic assays ( ) . therefore, we assembled a panel of human serum or plasma and polyclonal antibodies to compare the performance of serologic assays for mers-cov. we invited participants to use their testing algorithms to diagnose each sample as if it were a real patient sample. the assays were evaluated for sensitivity and specificity. pas et al. described in the impact that a single international standard would have on reducing interlaboratory variability for mers-cov diagnostics (albeit in this case for nat assays) ( ) . to this end, we included samples in the panel as examples of potential who international standard material, and we assessed their effectiveness in harmonization of the data from the participant laboratories. the national institute for biological standards and control (nibsc) human material advisory committee (project / mp) approved this project. the ministry of health, oman; ministry of health, saudi arabia; and korea national institute of health, south korea, donated convalescent serum and plasma samples from pcr-confirmed mers-cov-infected patients. all patient donors gave informed consent for the use of their serum or plasma, and samples were anonymized. we treated all mers-cov convalescent-phase serum and plasma with solvent detergent using a validated method ( ) to ensure there was no residual infectious virus. we stored all study samples at - °c until dispatched on ice packs to participants. we blind coded the study samples provided to the participants (table ) . we included plasma samples (samples , , , , and ) as individual patient samples. other smaller serum donations were pooled in samples (samples , , and ) based on their antibody titer, which we determined using the recombivirus human mers-cov nucleoprotein (np) antibody (igg) elisa kit (alpha diagnostic international, https:// adi.com). we categorized samples into high-, medium-, or low-positive pools ( figure ). we included mers-cov-negative serum with antibodies against other human coronavirus hcov- e, hcov-nl , hcov-oc , and hcov-hku (samples , , , , , , and ) to test specificity of the assays ( table ). co-authors a.s., m.a.m., and c.d. precharacterized and donated these samples. purified human mers polyclonal antibodies from transchromosomal (tc) cattle ( ) immunized with either recombinant spike protein or whole inactivated virus (samples , , and ) were donated by eddie j. sullivan (sab biotherapeutics, inc., sioux falls, sd, usa). we diluted the material in universal buffer ( mmol/l tris-hcl, ph . , . % human serum albumin, % trehalose) at a concentration of mg/ml. the participating laboratories (listed at the end of this article) were located in australia, china ( mainland, hong kong), germany, south korea, the netherlands, united states, and the united kingdom ( laboratories). participating organizations included national control laboratories, diagnostic laboratories, and research laboratories. participants tested the sample panel using their routine assays for mers-cov serology. we asked participants to perform independent assays on different days. we provided an excel spreadsheet (microsoft, http://www.microsoft.com) for reporting the raw data for each assay and any interpretation of the results, such as positive or negative diagnosis of the samples. we combined titers and relative potency (relative titer) estimates as unweighted geometric means (gms) for each sample and laboratory and used these laboratory gms to calculate overall unweighted gms for each sample. we expressed variability between laboratories using geometric coefficients of variation (gcv = [ s − ] × %, where s is the sd of log transformed estimates). to mitigate the effect of any potential outliers, we calculated robust estimates of s using the r package wrs ( ). we referred to all participating laboratories by code numbers, which were randomly allocated. if a laboratory returned data using different assay methods, we assayed the results separately for each method and referred to them according to their laboratory number and assay code; for example, ppnt (pseudoparticle neutralization test) and tcid ( % tissue culture infectious dose). a total of datasets were returned (table , https://wwwnc. cdc.gov/eid/article/ / / - -t .htm). data covered a range of different assay formats: neutralization assays, eli-sa, immunofluorescence tests, and microarray. in general, there was good agreement between all the assays tested in this study. in assays with a quantitative measurement, the limit of detection and titer of samples varied greatly, but overall determination of positive or negative agreed between all assays except for (laboratory tcid mn [microneutralization]), which failed to detect positive samples (samples and ) that all other tests detected as positive. the panel of negative control samples was deemed to be negative in all quantitative assays. there were instances of laboratories reporting a result above cutoff for samples in assay, but these samples were correctly diagnosed as negative overall by their testing algorithms: laboratory detected samples and as above cutoff at : dilution in assay only; laboratory detected sample as above cutoff at : and : dilutions in assay; and laboratory detected sample as above cutoff at dilution tested. participants detected pool a, the high-titer mers-cov antibody pool (sample ) in all assays (table ) . they detected pool b, the medium-titer pool (sample ), in all but of the quantitative assays, a tcid mn assay from laboratory . in all other quantitative assays, participants detected the high pool at a higher titer than the medium pool. in the qualitative assays, assays gave borderline positive or equivocal results for the medium pool; these assays were a euroimmun s elisa (https:// www.euroimmun.com) in laboratories and and an in-house immunofluorescence assay in laboratory . the low-positive pool (pool c, sample ) was only detected as positive in a single assay in the study, the alpha diagnostic international mers np elisa performed in laboratory . participants scored positive the purified igg samples from mers-cov-immunized transchromosomal bovine samples (samples and ) in all the qualitative assays, but of the quantitative assays, n elisa from laboratory and the alpha diagnostic international mers np elisa from laboratory , were unable to detect these samples. we expected these np assays to fail to detect sample because this antibody was raised against recombinant emerging infectious diseases • www.cdc.gov/eid • vol. , no. , october mers spike protein only; however, it was surprising that the assays did not detect sample , which was an antibody raised against whole inactivated virus. for the individual convalescent-phase plasma samples, we saw more variability in the results when compared with the pooled material, but despite this, of the samples (samples , , and ) were correctly identified as positive in all tests. sample was correctly diagnosed as positive in all tests but was identified as borderline positive by laboratory in a euroimmun elisa assay. sample was the most difficult individual patient plasma to detect as positive; it was negative in the tcid mn assay in laboratory ; equivocal/positive in the in-house immunofluorescence assay in laboratory ; and, in the euroimmun elisa, borderline/negative in lab , equivocal in lab , and weak positive in lab . sample was the weakest positive of the individual samples tested in the panel, as we saw from the titers in the quantitative assays that detected it as positive. we compiled the results of quantitative assays for the individual positive plasma samples ( figure ). to simplify comparison of the assays, we reported results from the different laboratories as relative to either the transchromosomal bovine igg sample raised against whole inactivated virus (sample ) or the high-positive pooled human serum (pool a, sample ). when we expressed data as a potency relative to either of the chosen potential reference preparations with an assigned arbitrary value of , , we observed improvement in the agreement between tests (table ; figure ). we saw the greatest reduction in the variation between laboratories (smaller sem in figure and smaller percentage geometric coefficient of variation [gcv] in table ) when we used pooled human serum (sample ) as standard. the transchromosomal bovine igg raised against whole virus (sample ) showed a substantial improvement in the agreement between laboratories; however, elisa methods included in this study could not identify this sample as positive. as detection of sporadic cases of mers-cov continues, development of new vaccines to combat the disease remains important, as does serosurveillance to understand exposure to the disease and the severity of illness in persons exposed to the virus ( ) . the importance of serologic assays for the diagnosis of mers cases should also be considered; the who guideline for laboratory testing for mers-cov, updated in january , specifically includes sample collection from suspected mers-cov cases for serology ( ) . the guideline lists situations in which laboratories should conduct serologic testing for mers-cov: for defining a sporadic mers-cov case if molecular testing, such as nucleic acid amplification methods, is not possible; as part of an investigation of an ongoing outbreak; or serologic surveys, such as retrospective analysis of the extent of an outbreak. in this collaborative study, we evaluated the performance of assays to detect mers-cov antibodies using a panel of serologic samples. all laboratories correctly identified the negative samples in the panel, including those containing antibodies against other coronaviruses, implying good specificity of the assays. laboratories reported the positive results correctly except for sample , which tested negative by all but assay; however, these results demonstrated the importance of a testing algorithm. we observed instances of a sample being incorrectly determined as negative or borderline/equivocal in a single test in a single laboratory (table ) . however, because each laboratory used a testing algorithm involving > method of analysis, all the samples with sporadic spurious results were correctly diagnosed as positive or negative; if they had used a single assay type, we would have found a higher proportion of incorrect results. the results for sample , which was a pool of serum samples from patients with confirmed mers-cov, highlight a lack of sensitivity in most of the assays in this study; further investigation would be needed to determine why the antibody titers in this pool were below the limit of detection in all but assay targeting n protein. it is important to understand whether there is a specific window of time in which clinical samples for serology should be taken or whether some patients do not mount a detectable antibody response against the spike protein during infection. such information may lead to further updates of who guidelines on laboratory testing for mers-cov. the raw titers reported from the laboratories performing quantitative assays varied greatly, for some samples > , -fold, between laboratories ( table ). the use of a reference material in the assays tightened the values from the laboratories for all the samples, enhanced comparability (figure ) , and reduced the gcv percentage between all laboratories (table ) , perhaps unsurprisingly, but the magnitude of reduction in gcv percentage was noteworthy. mers-cov is an example of an important emerging pathogen with potential to cause outbreaks; diagnostic tests for emerging pathogens are often developed during outbreaks without proper validation or calibration. this study showed the importance of using a standard reagent to allow better comparison of results from different laboratories or interpretation of results from different studies or clinical trials. as we continue to face emerging pathogens, which pose significant risks to human health, it is important to use the experience gained from studies such as this to improve our response to the next threat. standardizing assays is a key issue when different groups around the world are working to develop and produce novel assays and vaccine products. the need for a standard for mers-cov serology was discussed and was widely supported at the who-international vaccine institute joint symposium for mers-cov vaccine development in seoul, south korea, june - , . several potential vaccines are in development, and the immune response elicited, their efficacy, and correlates of protection must be assessed. the use of a reference such as who international standards ( ) will enable worldwide harmonization of assays and comparability of the results from different preclinical and clinical studies. assessing the specificity and sensitivity of methods is crucial to improve our understanding of the use and limitations of serologic assays for emerging diseases for which we have little knowledge of disease progression, antibody profiles, and other key information that is available for other infectious diseases. national institute for viral disease control and prevention department of viroscience high-containment microbiology isolation of a novel coronavirus from a man with pneumonia in saudi arabia world health organization. who mers-cov global summary and assessment of risk scope and extent of healthcare-associated middle east respiratory syndrome coronavirus transmission during two contemporaneous outbreaks in riyadh, saudi arabia middle east respiratory syndrome coronavirus (mers-cov) mers-cov in upper respiratory tract and lungs of dromedary camels, saudi arabia reported direct and indirect contact with dromedary camels among laboratory-confirmed mers-cov cases annual review of diseases prioritized under the research and development blueprint a roadmap for mers-cov research and product development: report from a world health organization consultation report on the intercountry meeting on the middle east respiratory syndrome coronavirus (merscov) outbreak in the eastern mediterranean region geneva: the organization first international external quality assessment of molecular diagnostics for mers-cov robustness of solvent/detergent treatment of plasma derivatives: a data collection from plasma protein therapeutics association member companies triple immunoglobulin gene knockout transchromosomic cattle: bovine lambda cluster deletion and its effect on fully human polyclonal antibody production wrs : wilcox robust estimation and testing mers: progress on the global response, remaining challenges and the way forward world health organization. laboratory testing for middle east respiratory syndrome coronavirus interim guidance recommendations for the preparation, characterization, and establishment of international and other biological reference standards (revised we thank the following institutions and organizations: universitätsklinikum, bonn, germany; charité-universitätsmedizin, berlin, germany; korea national institute of health; the central public health laboratory, ministry of health, sultanate of oman; public health department, supreme council of health, qatar; the ministry of health, public health directorate, kingdom of saudi arabia; sab biotherapeutics, south dakota, usa. we also thank humayun asghar from the who eastern mediterranean regional office for assistance obtaining the serum for the study. dr. harvey is a principal scientist at the national institute for biological standards and control, united kingdom. her research interests include influenza virus vaccines and respiratory viruses including mers coronavirus. key: cord- -m awr rm authors: saad, julian m.; prochaska, james o. title: a philosophy of health: life as reality, health as a universal value date: - - journal: palgrave commun doi: . /s - - - sha: doc_id: cord_uid: m awr rm emphases on biomarkers (e.g. when making diagnoses) and pharmaceutical/drug methods (e.g. when researching/disseminating population level interventions) in primary care evidence philosophies of health (and healthcare) that reduce health to the biological level. however, with chronic diseases being responsible for the majority of all cause deaths and being strongly linked to health behavior and lifestyle; predominantly biological views are becoming increasingly insufficient when discussing this health crisis. a philosophy that integrates biological, behavioral, and social determinants of health could benefit multidisciplinary discussions of healthy publics. this manuscript introduces a philosophy of health by presenting its first five principles of health. the philosophy creates parallels among biological immunity, health behavior change, social change by proposing that two general functions—precision and variation—impact population health at biological, behavioral, and social levels. this higher-level of abstraction is used to conclude that integrating functions, rather than separated (biological) structures drive healthy publics. a philosophy of health provides a framework that can integrate existing theories, models, concepts, and constructs. a philosophy of health w hat is health? is it a state of the body or the mind? is health primarily a natural, biological state or a holistic, value-laden state? naturalistic and holistic philosophies of health have provided very important, but very different, perspectives of population health. naturalistic views (e.g. as seen in boorse, ) provide insight into physical, natural, biological, or physiological processes that are tangible (in the material sense), observable, and measurable with modern technology. complementarily, holistic views contend that value-laden phenomena (e.g. vital goals, meaning, and purpose) play a central role in population health (nordenfeldt, ) . a dialog, or as we see it, an important dialectic among naturalistic and holistic perspectives plays out between the biostatistical theory of health (bst) and the holistic theory of health (hth). the bst posits that a person is healthy if and only if, all natural organs function normally given a statistically normal environment (boorse, ) . the hth posits that a person is healthy if and only if (given standard circumstances) he/she has the ability to attain their vital goals (nordenfeldt, ) . in addition to defining health, each philosophy defines disease. the bst poses that disease is the internal state of impairment to the normal functioning of organs (boorse, ) . in the hth, an organ dysfunction is a disease if and only if the organ's process reduces the person's ability to pursue vital goals or life-purpose (nordenfelt, ) . in bst health is the absence of disease; and in hth, health is not the absence of biological disease, but is the whole person's ability to function in relation to vital goals. both naturalistic and holistic perspectives guide important observations of health and disease. when one considers health through the bst one pays close attention to the functions of the internal, biological functioning of the human being. when one considers health through the hth, one pays close attention to the functioning of an individual, in relation to their external, societal/ cultural functions. is there a hybrid model that accounts for both internal and external functioning? wakefield's ( ) harmful dysfunction analysis (hda) creates a hybrid model that integrates natural-and value-laden phenomena when conceptualizing disease. hda asserts that a person suffers from a disorder/disease if ( ) the condition causes harm (as judged by the standards of the person's culture); or if ( ) the person's internal, natural processes cannot perform normal functioning (as judged by the standards set by evolution). hda creates a hybrid model that can integrate perspectives of the bst (i.e. by considering internal organ functioning); and the hth (i.e. by considering external societal/goal functioning). however, while hda may define health processes in relation to disease, it serves primarily as an integrative model of disease. is there an integrative model of health that can account for natural and value-laden functions? schroeder ( ) identifies a significant, common thread among these competing (or perhaps complementing) philosophies: functionalism. the researcher suggests that each philosophy is concerned with the functioning of organisms. although the bst, hth, and the hda might not agree on which functions inform the first principles of health, schroder ( ) uses higherlevel abstraction to identify one common first principle: the state of functioning in an organism impacts its state of health. when paralleling the three philosophies based upon functioning one might observe that ( ) bst declares an individual healthy if its organs function normally; ( ) hth declares an individual healthy if he/she can function in relation to vital goals; and ( ) hda declares an individual unhealthy if internal mechanisms cannot perform natural, evolutionary functions, and/or when a condition prevents a person from functioning in relation to goals/norms/values. through this higher-level abstraction, an integration of seemingly separate philosophies of health is made possible. learning from leaders in the field. as we attend to these philosophies of health, we too observe how discussions about functions and functioning produce integrative perspectives. although a definition of "function" is not explicitly stated in the above research, it appears that nordenfeldt ( ) , boorse ( ) , wakefield ( ) , and schroeder ( ) are each discussing functions as pre-existent (i.e. either from evolution, personal goalsetting, cultural tradition) processes-with-purposes. whether one is describing a value-laden function (e.g. decision-making in pursuit of a valuable career) or an evolutionary-biological function (e.g. the heart beating for circulation), each process (i.e. decision-making processes or cardiac processes) serves identifiable purposes (e.g. maintained financial stability or maintained blood flow). whether an organ is functioning normally in relation to the body or a human being is functioning in relation to vital goals, it appears that both perspectives consider if an active "process" (i.e. an organ's activity, an individual's activity) can express its "purpose" (i.e. evolutionary-purpose, life-purpose). in the present manuscript we will propose that naturalistic and holistic perspectives can be integrated within a single philosophy of health. we will propose two universal functions-termed precision and variation-that can account for both natural functions and value-laden functions of the existing philosophies. this functional language will support a higher level of abstraction that integrates, rather than separates, biological functions, behavioral functions, and social functions under a philosophy of health. the need for new perspectives in population health. the chronic disease crisis beckons the need for an updated philosophy of health that can account for biological, behavioral, and social functioning. why? chronic diseases, which account for % of all-cause deaths worldwide (chartier and cawthorpe, ) , do not emerge from naturalistic, biological, or physical contact with an illness. rather, chronic diseases do emerge in biological functions (e.g. tumor proliferation in an organ) after prolonged contact with health risk behaviors and lifestyle factors that active the conditions (mokdad et al., ; edington, ; li et al., ) . chronic diseases are not curable by purely naturalistic or biological means (e.g. pharmaceuticals). rather, some diseases may be effectively prevented or intervened on through healthy behavior (dansinger et al., ; daubenmier et al., ) . population health risk behaviors are unique determinants of population health because researchers can actively observe how they simultaneously alter biological functioning (e.g. chronic smoking alters cells in lung tissue), behavioral functioning (e.g. chronic smoking alters decision-making and daily habits) and social functioning (e.g. chronic smoking creates an economic, social, and healthcare burden) of the population. these behaviors not only have biological, behavioral, and social implications for the individual doing the behavior, but also have intergenerational and interpersonal effects. the individual who binges on refined sugar not only puts themselves at risk of diabetes, but can put their future offspring at risk. the individual who smokes two packs of cigarettes per day not only puts themselves at risk of lung cancer, but can put their housemates at risk of lung cancer from second-hand smoke. therefore, the chronic disease crisis is neither purely naturalistic, nor purely value-laden; rather it reflects an integration of natural and value-laden phenomena. there remains a real need for principles of health that can integrate existing naturalistic and holistic perspectives of population health. the principles since april , , the constitution of the world health organization ( ) has utilized an intuitive definition of health by suggesting that health is "a state of complete physical, mental, and social well-being." while this definition might be intuitive and even accessible to a wide audience; the defininition is not necessarily researchable across health disciplines. integrating principles of health might begin with a common-sense definition of health that can also be upheld across existing naturalistic and holistic perspectives. without operationally defining functions that drive physical, mental, and social well-being, it is a challenge for multidisciplinary collaborators to unite under the who mission. further, without a common definition of health, important communications from patients to doctors, from subjects to researchers, from researchers to collaborators, and from peer-reviewers to peer-reviewees, can become fragmented or lost in translation. in the proceeding sections, a common-sense definition of health is used to present the first principles of a philosophy of health. principle : "health" is the state of maintainable-ease of functioning. a "disease" is a state of prolonged-dysfunction that prevents ease. chronic diseases emerge from prolonged exposure to dysfunctional behaviors like smoking, alcohol abuse, unhealthy diet, and inactivity (mokdad et al., ) that also create dysfunctional expressions of life functions. smoking creates dysfunctional breathing; alcohol abuse creates dysfunctional drinking; sugar binging creates dysfunctional eating; and sedentary behavior creates dysfunctional moving. when these health risk behaviors lead to chronic disease, they have already prolonged dysfunctional breathing, drinking, eating, and/or moving. the chronic smoker breathes in smoke so frequently that he no longer experiences an ease-of-breathing. rather, his breathing becomes short and shallow. prior to the emergence of lung tumors, the chronic smoker prolongs dysfunctional patterns of breathing. the "couch potato" sits so frequently that he no longer experiences an ease-of-movement. rather his movement becomes rigid and limited. prior to the emergence of cardiovascular dysfunction or obesity, the sedentary person prolongs dysfunctional patterns of movement. if chronic smoking facilitates prolonged-dysfunction in breathing, and sedentary behavior facilitates prolonged-dysfunction in movement, what do functional breathing and moving look like? healthy breathing and moving (as well as eating and drinking) are characteristic of an ease of one's functioning that can be maintained in normal conditions. for example, the chronic smoker and the "couch potato" might report momentary-ease in breathing and posture when engaging in their health risk behaviors; but they do not maintain that ease outside of smoking or sitting. conversely, the yogi might report that their yoga practices expose them to momentary dis-ease in breathing and moving that lead to maintainable-ease in breathing and movement in everyday life. in contrast to disease as a prolongeddysfunction, healthy functioning can be commonly sensed as a maintainable-ease of functioning. when observing a disease, perhaps we are observing a prolonged-dysfunction that prevents ease. rather than define health as the absence of disease (as seen in bst), notice here how we instead define disease in relation to health; and we define health in relation to maintainability, ease, and functioning. consideration of "maintainable-ease of functioning" will allow us to consider how not all "dis-ease" is bad (i.e. exposure to acute dis-ease/stress maintains healthy functioning in the long-term); and not all "ease" is good (i.e. avoidance of stress and prolonged "comfort" creates fragility seen in sedentary behavior). we propose that: . dysfunction parallels a state of "dis-ease"; and prolongeddysfunction parallels the state of disease. . function parallels a state of "ease"; and maintainable-ease of functioning parallels the state of health. this definition of health will be applied in the proceeding principles to integrate naturalistic and holistic perspectives of population health. principle : health emerges from maintainable-ease of functioning at multiple levels. maintainable-ease of functioning in the general population can be observed at the level of the cell, the self, and the society simultaneously. cooperation across multiple levels of functioning is required for the organization and adaptation of living systems (nowak and sigmund, ; antonucci and webster, ) . when developing an integrative model of health, it is important to consider how biological cells, individuals, and the larger society simultaneously play a role in population health (xavier da silveira dos santos and liberali, ; antonucci and webster, ) . in this philosophy, we define health from three levels: cells, selves, and societies. what happens when these levels do not function in cooperation? when the functioning of cells disrupts the functioning of the self, a state dis-ease in the self can follow. for example, prolonged dysfunction in autoimmune conditions can lead to prolonged dysfunction for the (individual's sense of) self by triggering depression, decreased motivation, or anxiety (lougee et al., ; garud et al., ) . the reverse can also be true. when the functioning of the self (i.e. one individual) disrupts the functioning of their cells, a state dis-ease in the cells can also follow. for example, prolonged sugar binging and addictive eating can lead to prolonged high blood sugar and pancreatic dysfunction seen in diabetes (de koning et al., ; imamura et al., ) . cells and selves are not separate. when the functioning of the self disrupts the functioning of the society we observe a state dis-ease in the society. for example, one person's unprotected sex with multiple partners can also lead to epidemics and social conflicts. the reverse can also be true. when the functioning of the society disrupts the functioning of the individual, a state dis-ease in the self can follow. for example, dysfunctional social conditions (as seen in rutter, ) , can lead to prolonged psychological and behavioral dysfunctions of individuals. selves and societies are not separate. when the functioning of society disrupts the functioning of cells, a state of dis-ease in the cells can also follow. for example, prolonged dysfunction in society in the form of misguided values about cleanliness, can lead to over-sanitization practices that create superbugs and antibiotic-resistant bacteria (zaccheo et al., ; finkelstein et al., ; bower and daeschel, ) . the reverse can also be true. when the functioning of cells disrupts the functioning of the society, a state of dis-ease in the society can follow. prolonged dysfunction in cells from naturally occurring parasites (e.g. yersinia pestis [cui et al., ] ) can lead to prolonged dysfunctions like the economic collapse following th century black death (haensch et al., ) . cells and societies are not separate. what does health look like when these levels work together? recent reports on the blue zones (i.e. the areas of the world where populations live significantly longer and healthier than the average) demonstrate that healthy functioning at these levels enhances physical longevity and mental wellbeing in populations (buettner, ; poulain et al., ) . buettner ( ) reports on how blue-zone populations intentionally and habitually enrich their physical bodies with healthy eating and physical activity. in addition to integrating physical and behavioral practices, these communities also integrate behavioral and social practices, such as, goal-setting, meditations/prayer, social engagement, pursuit of purpose, and community gathering. humor is used by individuals and groups as a means to practice ease when challenges present themselves (buettner, ) . blue zone communities place value upon physical/natural, behavioral and social processes, generating them intentionally and habitually. both states of ease and dis-ease can teach us about the contributions of cells, selves, and societies to population health. although it is important to be able to observe the levels separately to describe their contributions, it is also important to consider how the levels integrate to impact healthy publics. we acknowledge that meaningful changes can be observed above and below these levels (e.g. at the level of the biosphere and genome). however, this initial paper will introduce levels that are most proximal and accessible to the experience of a general readership (fig. ) . principle : health emerges from systems whose primary purpose is to generate maintainable-ease of functioning at a respective level. we propose that systems exist at each level with the purpose of generating maintainable-ease of functioning at that level. the biological immune system, an individual's system of health behaviors, and the social system will be observed as systems that generate maintainable-ease of functioning in cells, selves, and societies respectively (fig. ). principle a: the biological immune system is directly responsible for maintainable-ease of functioning at the level of the cell. throughout the course of human evolution, the complexity and biodiversity of the human body continued to increase (rodríguez et al., ) . what keeps the trillions of cells and microorganisms in cooperation in a human body? the biological immune system maintains functional cells (rodríguez et al., ) . although it is documented that the functioning of the biological immune system has implications for behavioral functioning (ader, (ader, , johnston et al., ; cdc, ) and social functioning (cdc, ; reidel, ; cutler and miller, ) the system's primary purpose is supporting functioning in the cellular/biological system. principle b: health behavior is directly responsible for maintainable-ease of functioning at the level of the self. throughout the course of time, the complexity of human behavior, has continued to increase (boulding and khalil, ) . what keeps an individual in a state of balance during times of rapid change? one's system of health behaviors (e.g. one's practices of breathing, drinking, eating, and moving) maintain a functional self. although it is well documented that the behavior of the individual impacts biological functioning (fadel, (fadel, , and social functioning (omer et al., ), one's system of health behaviors directly impacts one's experience of (or one's 'sense of') their "self". principle c: the social system is directly responsible for maintainable-ease of functioning at the level of the society. throughout history, the social diversity of human societies continued to increase. during periods of rapid increases in social diversity and cultural integration, what supported cooperation in the society? social systems (e.g. public governments, private social organizations, religious/spiritual organizations) emerge to maintain a functional society. although it is well documented that a social system can impact biological functioning (cdc, ; riedel, ; cutler and miller, ) and behavioral functioning (buettner, ) , the social system's primary role is to maintain functions at the level of the society. principle d: by considering health as maintainable-ease of functioning generated by systems, we have the ability generalize health across levels. to observe health at the level of the cell, the self, and the society simultaneously, we consider systems that support maintainable-ease of biological, behavioral, and social functioning. the biological immune system, an individual's system of health behaviors, and the social system make meaningful contributions to the functioning of cells, selves, and societies, respectively. while these systems are not the only systems that impact each level (e.g. one's cardiovascular system impacts cells, one's "personality" impacts the self, the environment impacts society), the biological immune system, health behavior, and the social system have great implications for population health from their respective levels; and they can be operationalized at these levels based upon their functions. by considering health as maintainable-ease of functioning (rather than maintained biological structures) at multiple levels, we set a point of reference from which to integrate important determinants of population health. when taking the structuralist's perspective, the biological immune system, health behavior, and social systems appear as distinctly separated. when taking a functionalist's perspective, the biological immune system (i.e. the integration of host defense functions and microbiota functions), one's (system of) health behaviors (i.e. the integration of decisionmaking/executive functions and habits/habitual life functions), and the social system (i.e. the integration of population values and population behaviors) appear together in a philosophy of health. fig. the levels of functioning. this philosophy of health investigates three levels of health: cell, self, and society. the level of the cell accounts for biological functioning within human beings. the level of the self accounts for first-person functioning of each human being. the level of the society accounts for group functioning of human beings. fig. the systems at each level. each system is responsible for generating maintainable-ease of functioning at a level. the biological immune system is responsible at the level of the cell. a human's system of health behaviors is responsible at the level of the self. the social system is responsible at the level of the society. article palgrave communications | https://doi.org/ . /s - - - principle : each system employs two general functions-variation and precision-to generate maintainable-ease of functioning at a level. the functionalist perspective allows us to observe systems based upon their functions. the biological immune system will be observed as an integration of host defense functions and microbiota functions (hooper and littman macpherson, ) ; ( ) an individual's system of health behaviors will be observed as an integration of decisions/executive functions and habits/habitual life functions (de bruin et al., ; verplankern, ; norman et al., ; prochaska et al., ; prochaska et al., ) ; and the social system will be observed as an integration of actively functioning values and population-wide behaviors that function in relation to those values (dowling and pfeffer, ; cotgrove and duff, ) . by researching the role of these functions at each level, we distilled two general functions of each system: variation and precision. variation appears in the functions of each system that generate a range of abilities, the "varied-abilities", that sustain health in presently changing conditions. the microbiota, habits/ habitual life functions and population behaviors will be observed (in principle a) as the variation-functions of the biological immune system, health behavior, and the social system, respectively. precision appears in those functions that prioritize and organize the patterns of variation that can sustain health at a level in future, changing conditions. the host-defense functions, decision-making/executive functions, and values systems will be observed (in principle b) as the precision-functions in the biological immune system, health behavior, and the social system, respectively. consideration of a complementary relationship among precision and variation is not novel. precision and variation have been discussed as central to the development of neural and biological systems (hiesinger and bassem, ) . discussions of precision and variation have also provided important insight into research on the biological immune system (albert-vega et al., ; brodin et al., ) . through this philosophy, one can go beyond biological systems to observe how precision (in the form of hostdefense functions, decision-making/executive functions, and values) and variation (in the form of microbiota functions, habits/habitual life functions, and population-wide behaviors) integrate to generate to maintainable-ease of functioning in cells, selves, and societies simultaneously (fig. ) . principle a: variation is responsible for generating the range of abilities, the "varied-abilities", that can express ease-of-functioning in presently changing conditions. without functional variation, life is fragile because the present environment is always changing (taleb and blyth, ) . fragile systems' inability to experience changing conditions (in part) relates to limited variability. conversely, adaptive system's ability to experience changing conditions (in part) relates to functional variability (taleb, ) . when one microorganism in the microbiome takes over, biological fragility reflects a state of infection. when one habit takes over, behavioral fragility reflects a state of an addiction/dependence. when one population behavior takes over (e.g. when economic participation or access to food is restricted to a small percentage of the population) social fragility reflects a state of social/civil unrest. the human microbiota is comprised of trillions of microorganisms, such as bacteria, fungi, and viruses. when variability in the human microbiota exists, an ease of functioning, or "homeostasis" in cells can be expressed in the present biological/ ecological environment bogaert et al., ; claesson et al., ) . research demonstrates that variation in the microbiota impacts the health of human cells by metabolizing complex carbohydrates, converting proteins to neural signals, and modulating diurnal rhythms that maintain biological homeostasis (clemente et al., ; rothe and blaut, ; blaut and clavel, ; de vadder et al., ) . when variation in the microbiota is dramatically limited or changed (e.g. following antibiotic overuse), cellular tissue in the human body is fragile and vulnerable to infections, allergies, and inflammatory outbreaks (francino, ) . when one's habitual life functions (e.g. breathing, drinking, eating, and moving) and one's healthy habits (e.g. one's weekly exercise schedule, or weekly meal preparation) can be expressed freely, an ease of functioning is felt by one-self in the present environment. when life functions are no longer expressed with ease (e.g. breathing and movement are compromised due to prolonged sedentary lifestyle), or when a single habit takes over one's lifestyle (e.g. smokes breaks "must" occur every min), an individual is vulnerable to stressful outbreaks and chronic states (al'absi, ; conrad et al., ; suess et al., ; león and sheen, ; parrott, ; koob, ) . when the basic human rights in a society are preserved in the present (e.g. right to life, freedom of speech; right to property), human populations have the ability to freely engage in the population-wide behaviors (e.g. health behaviors, social behaviors, economic behaviors) that support a functioning society. health behaviors drive health and longevity. social behaviors drive communication and cooperation. economic behaviors drive goods and resources. when these population-wide behaviors are chronically restricted in a population (e.g. poor access to health care, oppression of free-speech, economic crash), societies become vulnerable to social/civil unrest [as commented historically by victor frankl ( ) , alexander solzhenitsyn ( ) , franklin d. roosevelt ( ) , and dr. martin luther king ( ) ]. variation is essential so that a system has varied-abilities that can express ease-of-functioning in present environmental conditions. dramatic and prolonged restrictions to variation in the microbiota, habits/habitual life functions, and population-wide behaviors characterize fragile and vulnerable states in cells, selves, and societies. conversely, functional-variation supports resilience, robustness, and antifragility (taleb, ) . this does not mean that infinite variation is desirable; however, in this philosophy, precision is responsible for organizing expressions of variation so that the system does not degrade into unpredictably random variation or chaos (see principle b). fig. precision and variation in each system. maintainable-ease of functioning is generated by two functions in each system: precision and variation. the human microbiota, habits, and population-wide behaviors evidence variation in cells, selves and societies respectively. the host defense system, decisions, and values evidence precision in cells, selves and societies respectively. palgrave communications | https://doi.org/ . /s - - - article palgrave communications | ( ) : | https://doi.org/ . /s - - - | www.nature.com/palcomms principle b: precision is responsible for prioritizing and organizing the patterns of variation that maintain ease-of-functioning in future, changing conditions. some environmental changes are too challenging for ease to be expressed in the present. however, following an exposure to challenging conditions, some systems adapt and become more functional (taleb, ) . without the ability to functionally organize after stressors, a system degrades into disorder or chaos over time. host-defense functions, decision-making/executive functions and values systems prioritize and organize variation in the microbiota, habits/habitual life functions, and population behaviors respectively. when a pathogen invades the biological system, precise responses must occur to organize this potentially chaotic situation. at the level of the cell, a functional host-defense system (comprised of the innate, adaptive and complement immune system branches) organizes the biological system so that functional invaders (i.e. symbionts) and healthy cells are maintained and dysfunctional invaders (i.e. pathogens) and damaged cells are removed (hoeb et al., ; janeway, ; janeway and medzhitov, ; janeway et al., ) . when precision is dysfunctional, the host-defense system may ( ) fail to prioritize responses to a costly invasion, leading to a state of infection; or ( ) the host-defense system might prioritize dysfunctional responses to the cells of body that prolong a state of autoimmunity (naor and tarcic, ) . when a bad habit emerges, precise responses must occur to organize this potentially chaotic situation. at the level of the self, functional decision-making (or at smaller scales executive functioning) prioritizes and organizes behavior so that functional expressions of habit (or at smaller scales, habitual life functions) are prioritized regularly, and dysfunctional ones are replaced or minimized (de bruin et al., ; prochaska et al., ; prochaska and prochaska, ; prochaska et al., ; redding et al., ; weissenborn and duka, ; bickel et al., ) . when dysfunctional, decisions may ( ) fail to prioritize responses that remove a costly expression of habit (e.g. a teen started smoking cigarettes to "be cool" and now has to smoke in the bathroom before each class to get through the day; by not deciding to move at work, one's breathing becomes shallow and movement becomes rigid); or decisions may ( ) prioritize habits that prolong dysfunction despite knowing the dangerous consequences (e.g. an adult continues smoking cigarettes despite knowing the family's history of lung cancer; an adolescent continues binge on sugar despite a diabetes diagnosis). when dangerous population-wide behaviors threaten life in a society, precise responses must occur to organize this potentially chaotic situation. at the level of society, the agreed upon values organize the social system so that functional population behaviors are prioritized and dysfunctional population behaviors are minimized. functional values prioritize behaviors that support the society (e.g. as seen when societies mandate that students get certain vaccines before attending university), while also setting standards that remove/replace behaviors that threaten the society (e.g. new laws create legal repercussions for risk behaviors in society). without values that functionally prioritize populationwide behavior, society may ( ) fail to prioritize responses to a dysfunctional population behavior (e.g. as seen during aids epidemic of the s due to insufficient public health values around safe sex); or society may ( ) prioritize dangerous behaviors that can prolong societal dysfunction (e.g. the antibiotic resistance crisis (ventola, ; michael et al., ) has been attributed in part to the over-valuing or over-use of antibiotic medications in healthcare practices). precision is essential so that a system can maintain ease-offunctioning in future, changing conditions. when precision does not adequately detect the presence of costly conditions, a response may not be prioritized (e.g. as seen during acute infection, addiction/dependence following a surgery, the aids outbreak in the s). when precision prioritizes responses that prevent ease longitudinally, dysfunction is prolonged (e.g. autoimmunity, continued smoking despite family history of cancer, misguided values that create an antibiotic-resistant bacteria). through dysfunctional-precision, the conditions for life in cells, selves, and societies becomes disordered over time. through functional-precision, a system prioritizes responses that maintain ease-of-functioning in future conditions. prioritizing functional microorganisms (i.e. symbionts) supports the developing life of cells; prioritizing functional habits (e.g. weekly exercise) and habitual life functions (e.g. diaphragmatic breathing and relaxed movement) supports the developing life of the self; and prioritizing functional population behaviors (e.g. access to functional health care, economic resources; access to social support) supports the developing life of the society. principle : health is valued by a system when precision-andvariation generate maintainable-ease of functioning. health is de-valued by a system when precision or variation prevent maintainable-ease of functioning. by defining precision-andvariation, we can better understand maintainable-ease of functioning in population health: • functional-variation generates ease-of-functioning in the present (e.g. fluid and variable motion reflects an ease and variability of one's movement); while functional-precision prioritizes expressions that can maintain ease-of-functioning in the future (e.g. prioritizing challenging exercise for min each day may lead to an ease in bodily movement long term). • dysfunctional-variation prevents ease-of-functioning in the present (e.g. prolonged sitting might lead to rigid movement and shallow breathing); while dysfunctional-precision might prioritize expressions that prevent ease in the future (e.g. rather than focus on relaxing breathing and movement on work breaks, one decides to drink alcohol to relax). without functional-variation, life is fragile and vulnerable to changing conditions of the present. without functional-precision, life becomes disorganized from the system's exposure to changing conditions across time. when functional-and-integrated, precision-and-variation value maintainable-ease of functioning in cells, selves, and societies. when dysfunctional or fragmented, precision or variation can de-value maintainable-ease of functioning in cells, selves, or societies. if maintainable-ease of functioning can be valued in cells, selves, and societies, we will likely observe healthy publics. five principles of health are presented: ( ) health is the maintainable-ease of functioning; ( ) maintainable-ease of functioning emerges from multiple levels; ( ) at each level, maintainable-ease of functioning is generated by systems; ( ) each system employs two functions, precision-and-variation, that generate maintainable-ease of functioning; and ( ) health is valued by a system if precision-and-variation generate maintainable-ease of functioning. through these five principles, both naturalistic and holistic perspectives can be considered simultaneously because maintainable-ease of functioning is relevant to biological functioning (e.g. as described in bst) and personal/social, goal-oriented functioning (e.g. as described in hth). this philosophy can also be used to investigate how naturalistic and holistic phenomena have informed past healthcare interventions. what do vaccine interventions, behavior change interventions, and social change interventions have in common? when successful, these interventions enhance both precision and variation. vaccine interventions can enhance both the precision of the host-defense functions and variation in the microbiome. during a vaccine intervention, the microbiome is exposed to a new variation in the form of a new virus (reidel, ) . through this exposure, the precision of host defense functions can adapt to prioritize maintainable-ease of functioning in the microbiome in the future. how? the host-defense system produces antibodies that allow the immune system to respond effectively and efficiently to this virus when exposed to it again in the future (janeyway, ) . although the precision of the immune system has been enhanced to handle historical threats through vaccines (e.g. for small pox, chickenpox, measles), new viruses like the coronavirus can still emerge. with this philosophy, vaccine developers and public health officials might not only ask the question, "how do we combat the coronavirus?" researchers, vaccine developers and public health officials may also ask the functional question: "how do we enhance the precision of the host-defense system and the variation of the human microbiome to adapt following an exposure to the coronavirus?" behavior change interventions can enhance both the precision in one's decisions and the variation in one's habits. during a behavior change intervention, a person's existing habits are exposed to a new variation in habit. for example, the beginning of a new exercise intervention exposes the individual's current habits/habitual functioning to changes in movement and breathing (i.e. exercise) that may also change their patterns of eating and hydration. through this exposure, a person's decisionmaking might adapt to prioritize maintainable-ease of functioning in the individual's lifestyle. how? some behavior change interventions train one's decision-making to remove or "countercondition" unhealthy habits, by replacing them with healthy habits (prochaska et al., ) . although modern behavior change interventions have shaped the precision of decisionmaking during health behavior change (e.g. of smoking, diet, alcohol use, inactivity), new problems for health behavior still emerge when the individual is exposed to a new, potentially addictive technology. with this philosophy, behavior change interventionists and health officials might not only ask the question, "how do we support good decision-making of individuals?" researchers, behavior change technology developers, and public health officials may also ask the functional question: "how do we enhance the precision of one's decisions and the variation of one's habits following the exposure to a new, potentially addictive technology?" public health campaigns disseminated by social organizations can enhance the precision of the population's health values and variation in population-wide health behaviors. leading up to first surgeon general's advisory committee on smoking and health ( ) , the u.s. department of health had become increasingly aware of (i.e. exposed to) variations in a population health behavior. if populations smoked, then populations were more likely to develop lung cancer, laryngeal cancer, or chronic bronchitis (cdc, ) . following this exposure to (the consequences of) population smoking behavior, society's values shifted to prioritize health. how? the federal cigarette labeling and advertising act of was adopted, and the public health cigarette smoking act of was adopted to create new health values. this shift in values prioritized new variations in population health behavior by: ( ) requiring a health warning on cigarette packages; ( ) banning cigarette advertising in the broadcasting media; and ( ) calling for an annual report on the health consequences of smoking (cdc, ) . since these first initiatives adult smoking rates have fallen from about % (in ) to about % today; and mortality rates from lung cancer, the leading cause of cancer death, are declining (department of health and human services, ). although the precision of the population's values has been enhanced to impact population behaviors (e.g. the tobacco laws described above supported healthy change), new chronic states can still emerge following exposure to social changes (e.g. the invention of the juul impacted high school and college aged populations). with this philosophy, public policy officials and public health researchers might not only ask the question, "how do we create new laws to protect population health from nicotine addiction?" they may also ask the functional question: "how do we enhance the precision of the population's values and the variation of the population's behavior following the invention of a new nicotine delivery system technology (e.g. flavored juuls)?" previously we described that without functional variation, life is fragile when exposed to present changing conditions; and without functional precision, life becomes disorganized from exposure to changing conditions across time. when successful, the above interventions upon biological, behavioral, and social functioning have a common theme: each facilitates exposures to biological, behavioral or social conditions that support ( ) increasingly complex/diverse variation; and ( ) increasingly organizable precision. exposure, not avoidance, has facilitated population health in these interventions. while healthcare systematically prioritizes biological exposures in the form of vaccine interventions, they do not systematically prioritize behavioral or social exposures. however, it is documented that exposure to healthy behaviors in youth prevents risk behaviors in adolescence (velicer et al., ) ; and exposure to community-based health initiatives can support population health (dulin et al., ; cdc, ) . given that systematic biological exposures in the form of vaccination have led to a global control of some acute infectious diseases (tangermann et al., ) ; might systematic behavioral and social exposures (especially in youth) be needed to enhance global campaigns toward the control of chronic disease? a functional language of health is central to the success of a philosophy of health. why? the levels are not separate, but rather are continuously connecting with one another. a good philosophy of health should have the ability to discuss assessment, diagnosis, intervention, and prevention across levels, across systems, across cultural populations, and across time. using the common language of precision and variation creates discussions that connect the levels and integrate research disciplines. a case (to) study: mental health as between-level functioning in this philosophy. historically, and still too often, health professionals have an expertise at one level, that limits their prescription of interventions to that level. this can actually create barriers to a complete solution when a health problem is multileveled. while a person's mental health is typically assessed based upon their firstperson experience of thoughts, feelings, and behaviors; symptoms can be triggered by biological, physiological, behavioral, psychological, and/or social dysfunction. most clinicians typically do not have the ability to assess and address all forms functioning. so if one person, john, is meeting with a clinician who specializes in primary care medicine, he may only be prescribed a biological intervention like medication. if john is meeting with a clinician who specializes in behavioral medicine, he may only be prescribed a health behavior change intervention. if john is meeting with a clinician who specializes in a certain theory of psychotherapy, he may only be prescribed a psychotherapy intervention based on the clinician's training. if john is meeting with a clinician who specializes in social work, he may only be prescribed a group, community or social intervention. while the above specializations have been helpful in establishing an empirical bases for mental health interventions, overspecialization can be problematic when a multi-leveled solution is needed. in addition, it can also be problematic when a levelspecific solution is needed that the clinician cannot provide (e.g. when psychotherapy is needed but a clinician only has the ability to prescribe psychiatric medication). technology poses a multileveled issue for population mental health in . selves have more social connection then ever in history, yet societies are characterized by increasing rates of depression and loneliness (sum et al., ; hammond, ; srivastava and tiwari, ; twenge, ) . researchers might use this philosophy of health to facilitate between-level conversations that address seemingly paradoxical outcomes that emerge during this new age of rapid technological growth. to do this, a researcher might first begin by asking questions about functioning at each level; second, ask questions about processes between the levels; and third, concurrently ask questions at and between levels. first: begin by asking questions at each level. novel challenges face the igeneration (and their parents) due to technology's novel impacts on the development of individual and social functioning (twenge, ) . for example, if john's decisions (self-precision) and habits (self-variation) remain consistent during school hours because his parents do not let him have a phone; but his class' social behaviors around him (society-variation) change dramatically because everyone else at school uses the newest smartphone application to talk during class; will john's mental health suffer? although his parents' intentions are to protect john, the contrast between his behavior (self's precision-and-variation) and the population social behavior (society-variation) can impact john's health. notice here how we have not yet considered functions that connect the self to the society (e.g. john's thoughts and feelings). rather we first consider (or contrast) functioning at the level of the self (i.e. john's decisions-and-habits) and the society (i.e. population social behavior) in accordance with principles - (see figs - ). second: look for functional processes that connect the levels. one person's thoughts and emotions/feelings are processes that help to integrate the functioning of one-self within the functioning of a society. how might john's thoughts and feelings connect his (sense of) self to his society? perhaps john's parents teach him that it is important to feel separate from his classmates during class so he can think clearly in class; and that he can feel connected to his friends by inviting them over to communicate together after school. this parenting may impact john's thoughts and feelings during school. if john's parents do not talk with him about this topic, john may experience different thoughts and feelings during school hours. when kept to one-self, thoughts and emotions are foundational to an internal sense of self as one functions in the larger society; and, when acted upon, thoughts and feelings can become verbal communication (e.g. speech) and non-verbal communication (e.g. body language, facial expressions) that form an external sense of self that is visible to the society. the (internal) experience of and (external) communication of thoughts, feelings and actions form the foundation of all systems of psychotherapy (prochaska and norcross, ) . this view can be particularly helpful as researchers begin to investigate how smart technology impacts developmental changes to the self within the society beginning in youth. third: concurrently ask questions at and between levels. perhaps, a clinical researcher is interested in investigating protective mental health factors in the igeneration; and they hypothesize that lower rates of loneliness, anxiety, and depression will be seen in subjects that do not respond to text messages immediately. the researcher might investigate further by using the philosophy to develop questions for the research subjects: "( ) do you use conscious decision-making (self-precision) to prevent yourself from habitually responding to your phone when a text appears (self-variation)? ( ) how fast do other's in your social group typically respond to texts (society-variation)? ( ) what changes in thoughts and feelings are experienced (internal self-society connection) after you communicate via text (external self-society connection)?" perhaps this researcher also wants to investigate how those who are addicted to the technology perceive nonresponders. the clinical researcher might again apply the philosophy: "( ) how fast do other's in your social group typically respond to your texts (society-variation)? ( ) do you experience changes in thought and feeling (internal self-society connection) when others do not respond to you within an hour (societyvariation)? ( ) how do you communicate those thoughts and feelings (external self-society connection) with others when they do not respond for a prolonged period of time (society-variation)?" future research might use this method to gather and organize levels of information on mental health factors across different self-and societal-conditions. the processes that form our mental health form a functional connection between self and society. if mental health is a reflection of the self-society connection, what might be a reflection of the self-cell connection? physiological health evidences a functional connection between our sense of self and our cells. for example, aerobic exercise is a health behavior that stimulates changes to variations in breathing and movement. by engaging in this behavior, the biological cells of the body are also stimulated via various physiological processes. breathing will stimulate cellular functioning via the cardiovascular and respiratory systems; and movement will stimulate cellular functioning via the cardiovascular, musculoskeletal, and central nervous systems. while all physiological systems are working in collaboration in the body, certain changes to behavioral and biological functioning will stimulate certain physiological systems. by viewing health through this lens, between-level observations join the philosophy: biological functions emerge at the level of the cell; physiological functioning emerges as the cell-self connection; behavioral functions emerge at the level of the self; psychological/ mental functioning emerges as the self-society connection; and social functions emerge at the level of the society. future papers will explore maintainable-ease of functioning at and between levels. future directions: new images of healthcare integration and new perspectives of healthcare innovation. by considering this integrative philosophy, one can define health based upon a tangible connectedness, rather than separateness, of cells, selves, and societies. we provide image as a way to visualize the common paths to the health of healthy publics. when researchers observe that a host defense system is changing cellular functions following an infection, they may also expect these changes to have an impact [along path ] on expressions of habitual or physiological functions (e.g. immune function can stimulate the sensation of "achiness" or "pain" altering one's physical movement, breath rate, hydration, and hunger) (kelley, ; johnson et al., ; danzer, ) . when researchers observe an individual deciding to engage in health behavior change following an addiction, they may also expect these changes to have an impact [along path ] on the group-behavior of their family system or social systems. when researchers observe changes to society's values following a newly detected problem (e.g. laws ban cigarette advertising in broadcasting media; public health standards mandate certain vaccines before attending school), they may also expect that these changes can have an impact on behavioral functions of individuals [along path ] and biological functions of cells/organs [along path ]. these levels are continually integrating along these common paths to the health of healthy publics (fig. ) . when attending to this connectedness new, important questions can have new answers. what function does modern technology serve in population health and healthcare? if technology algorithms prioritize variations in population behaviors, then they fulfill a role as society-level precision. when modern technologies like machine learning (ml) technology and computer tailored interventions (cti) prioritize patterns of population behavior, we can see profound impacts on social change in a society. although one might argue that technologies can be used by individual-level functions, the algorithms that are currently deployed and updated on devices interface with bigdata gathered on population behaviors (manogaran and lopez, ; dinov, ; mullainathan and spiess, ; cheng et al., ) . in this paper, we identified that precision can be functional or dysfunctional. similarly, technologies can support or prevent healthy population behavior. some technologies prioritize health behavior in populations by tracking physical activity and providing feedback on activity progress; while others prevent healthy behavior by prioritizing sedentary behavior through video-gaming. some social media technologies facilitate social communication with distant friends and relatives that supports wellbeing; while others facilitate conflictual communication that diminishes wellbeing. given that modern technology can support or hinder health, we believe it is important that healthcare can prioritize technological innovations that value health in cells, selves, and societies. to do this, technology innovators might seek to value a higher order construct (e.g. maintainable-ease of functioning) in their algorithms. medical technology is currently used to titrate the doses of vaccines so that maintainable-ease of biological functioning (i.e. inoculation) is made available to the general population. when biological exposures are not properly titrated, infections can become active in the population and health is no longer valued at the level of the cell. similarly, when behavioral and social exposures are not tailored to the needs of individuals and groups, populations can become resistant to healthy change, and health is no longer valued at the level of the self and the society. behavior change researchers prochaska and prochaska ( ) report that when individuals and populations are not ready for a change, interventions that force individuals or populations to take action can increase resistance and prolong dysfunction. by tailoring (or what they term "staging") behavioral and social level interventions, computer tailored interventions upon behavioral and social functioning are made possible (prochaska et al., ; velicer et al., , prochaska and prochaska, ) . despite these advances, there remains a need for technological advances that can make maintainable-ease of behavioral and social functioning available to the general population. future healthcare interventions could benefit from ml algorithms that tailor behavioral and social exposures to enhance precision-and-variation. research already demonstrates that tailoring interventions for biological precision (albert-vega et al., ) and biological variation (brodin et al., ) can impact long-term biological functioning. future innovations might seek to use technology to tailor behavioral and social interventions to generate maintainable-ease of functioning. through the functional language used in this paper we hope readers are inspired to present new questions, new comments, and new perspectives about needed healthcare innovations. behaviorially conditioned immunosuppression on the development of psychoneuroimmunology immune functional assays, from custom to 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us. simon and schuster. us department of health and human services ( ) the health consequences of smoking- years of progress. a report of the surgeon general velicer wf the antibiotic resistance crisis: part : causes and threats habits and implementation intentions. the abc of behavioural change the biostatistical theory versus the harmful dysfunction analysis, part : is part-dysfunction a sufficient condition for medical disorder acute alcohol effects on cognitive function in social drinkers: their relationship to drinking habits basic documents. world health organization xavier da silveira dos santos a biocides and "superbugs this research was supported by funding from the national institutes of health's (nih) national cancer institute (nci). the authors declared the following potential competing interests: jop, ph.d. is a founder of the transtheoretical model (ttm) of behavior change, and is the director of the cancer prevention research center at the university of rhode island. jms, m.ed. is currently a ph.d. student conducting dissertation research on population health and behavior change under jop's supervision at the university of rhode island. correspondence and requests for materials should be addressed to j.m.s.reprints and permission information is available at http://www.nature.com/reprintspublisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons license, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons license, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this license, visit http://creativecommons.org/ licenses/by/ . /. key: cord- - lp t q authors: salman, m. d. title: the role of veterinary epidemiology in combating infectious animal diseases on a global scale: the impact of training and outreach programs date: - - journal: preventive veterinary medicine doi: . /j.prevetmed. . . sha: doc_id: cord_uid: lp t q abstract the effectiveness of detection and control of highly contagious animal diseases is dependent on a solid understanding of their nature and implementation of scientifically sound methods by people who are well trained. the implementation of specific detection methods and tools requires training and application in natural as well as field conditions. the aim of this paper is to present the design and implementation of training in disease investigation and basic veterinary epidemiology in selected countries using the highly pathogenic avian influenza (hpai) h n asia strain as a disease detection model. indonesia, egypt, nigeria, turkey, and vietnam were each identified as either a priority country where ai was spreading rapidly or a country at risk for infection. in each of these countries, a training program on epidemiological concepts, field investigation methodology, and detection of h n asia strain cases was conducted. this report includes the impact of these training sessions on national animal health programs, including follow-up activities of animal health officers who went through these training sessions. during the last two decades, there have been several emerging and new health events in humans that have received heightened attention from society in general. most of these health events were linked to animal diseases or originated in animal products, including highly pathogenic avian influenza (h n ), bovine spongiform encephalopathy, west nile virus, and severe acute respiratory syndrome. due to the extensive involvement of animals and their products in these events, animal health authorities have been involved in measures to minimize the spread and impact of these diseases. however, it has been the public health sector, particularly within central government or international agencies, that led the effort to control or eradicate these diseases. nevertheless, the prevention effort requires major involvement of animal health officers and others in related industries since the roots of most of these diseases are found in animal populations, particularly food-producing animals and wildlife species. the the effectiveness of detection and control of highly contagious animal diseases is dependent on a solid understanding of their nature and implementation of scientifically sound methods by people who are well trained. the implementation of specific detection methods and tools requires training and application in natural as well as field conditions. the aim of this paper is to present the design and implementation of training in disease investigation and basic veterinary epidemiology in selected countries using the highly pathogenic avian influenza (hpai) h n asia strain as a disease detection model. indonesia, egypt, nigeria, turkey, and vietnam were each identified as either a priority country where ai was spreading rapidly or a country at risk for infection. in each of these countries, a training program on epidemiological concepts, field investigation methodology, and detection of h n asia strain cases was conducted. this report includes the impact of these training sessions on national animal health programs, including follow-up activities of animal health officers who went through these training sessions. ß elsevier b.v. all rights reserved. animal and plant life or health. the agreement advocates the use of international standards from the world organization for animal health (oie), codex alimentarius (cac) and the international plant protection organizations (ippc) as the basis for recommended standards. it has therefore become obvious that the health status of animals and their products plays a major role in import and export regulations. this type of requirement for trade has placed pressure on the animal health program both nationally and internationally. veterinary professionals throughout the world, mainly through their animal health services, are faced with having to fulfill a crucial role in protecting their country's animal health status, providing sound surveillance information on the occurrence of diseases within their territories, and conducting scientifically valid risk analyses to establish justified import requirements. the majority of these tasks and activities require sound epidemiological approaches. veterinary epidemiology as a discipline has therefore become the main focus of the scientific community for effectively combating infectious animal diseases nationally and internationally. this paper presents the value and role of veterinary epidemiology in combating infectious animal diseases on a global scale, emphasizing the importance of training and outreach programs. three main topics will be addressed: veterinary epidemiology and its relation to the general discipline of epidemiology. global aspects of infectious animal diseases and their impact on trade and public health. training in veterinary epidemiology and its impact on constraining the spread of infectious diseases. particular examples and demonstrations are also presented in this paper. in late s the discipline of veterinary epidemiology began to be recognized as an important contributing discipline for animal production and public health aspects of veterinary medicine (schwabe, ) . modern veterinary epidemiology was established in response to demands by veterinary and public health professionals to aid them in handling health events, including suboptimal production, within highly intensive livestock operations. in the s and s, quantitative veterinary epidemiology was attractive to intensive livestock producers, practitioners and, to a certain extent, central and local governments (schwabe et al., ) . the term ''herd health'' was used interchangeably with modern veterinary epidemiology. the tools and techniques were mainly borrowed and modified from several other disciplines such as clinical medicine, quantitative sociology, statistics, pathology, ecology, animal sciences, and microbiology, among others and the approaches were mainly applied at the individual herd or farm level. the term ''micro-veterinary epidemiology'' was used to reflect the unit of interest/study as individual animals (schwabe, ; dohoo et al., ; martin et al., ; meek, ; schwabe, ) . the dairy sector pioneered this effort and was later followed by the poultry, swine and, to a certain extent, small ruminant and equine sectors. epidemiologic techniques were also later adapted by animal shelters, laboratory animal colonies, and in the management of free-ranging wildlife species. as a consequence to opening trade and the signing of the gatt agreement, the world started to take a different shape, especially in the early s. animal health programs were in the spotlight since the primary issue that would facilitate or impede the trade of animals and their products was their effect on the safety and health of humans, animals, and plants. comprehensive surveillance, quantitative disease indices, and science-based risk analysis were a few of the new terms that emerged during this critical time. veterinary epidemiologists, animal scientists, and agricultural economists started to apply some of the herd health tools on a larger scale within regions, zones, or countries. the term ''macro-veterinary epidemiology'' emerged as an important discipline in shaping animal health strategies and policies in several parts of the world. this term is actually not new to scientists and policy makers since economists have used it when the unit of interest is country based. nevertheless, not all the tools and techniques used in micro-veterinary epidemiology can be applied directly to macro-veterinary epidemiology. modifications and adjustments to some of these tools are required and these modifications have evolved out of necessity. the discipline of veterinary epidemiology so far has not addressed methods and techniques to differentiate between these two categories of its function. a national public health program (nphp) oversees the well-being of the people/society in the country with particular emphasis on community health quality including issues of food security, social health, and environmental contamination. activities related to this type of national program therefore include detection, response, prevention, and treatment of specific diseases such as tuberculosis, salmonellosis, west nile virus, and others. a national animal health program (nahp) monitors the well-being of animal populations in the country with particular differentiation between those associated with food production, pleasure animals and, to a limited extent, with companion animals. activities related to this type of national program are almost the same as those associated with a nphp with the focus on targeted animal populations. in addition, there are several overlapping activities between nphp and nahp particularly when adverse health events involve animals or their products. in the usa, for example, it seems that the nahp generally responds to the aftermath of specific adverse public health events that are initially recognized by nphp. the response from animal health authorities during the e. coli o :h outbreak, for instance, occurred after several fatal human cases were reported. the role of animal contamination in the salmonellosis outbreak in california via sewage was not investigated until the media made the issue public. the investigators, however, identified properly the link to human sewage contamination as the source of salmonella bacteria in this outbreak (kinde et al., ) . in the majority of cases the nphp reacts to emerging issues brought to the public attention by the media. an exception to this is the new initiative through national surveillance in which health events are monitored and analyzed for their impact on the community. regardless, the nahp is almost considered to be a secondary resource for managing adverse public health events instead of working side by side with nphp. although the media should not be ignored, their role in identifying an emerging disease event should be evaluated carefully. historically one activity of the nahp in the usa has been in disease-specific programs that were initiated as a result of the public health impact of zoonotic diseases. in the usa, the nahp has been successful in reducing the impact of diseases such as bovine brucellosis, bovine tuberculosis, salmonellosis in poultry products, rabies, etc. nevertheless, the interaction with the nphp has been limited because of inadequate administrative connection or, as in the case of brucellosis, a lack of interest from the public health sector when there are few human cases because of the success of the eradication effort of this disease from the cattle population. therefore, there has been limited knowledge about or appreciation for the accomplishments or progress of the nahp. consequently, the majority of methods and approaches used by the nahp have not been recognized or valued by public health agencies. since its inception, the nphp has by nature been proactive and dynamic. society and public decision makers have paid more attention to the public health aspect especially in regard to community-based diseases. limited attention has been paid to positive impacts of nahp disease prevention activities on public health in usa. for instance, decision makers rarely acknowledge the value of consistently safe and high quality food of animal origin. the success of the nahp has also contributed to better and more efficient animal production systems regardless of the zoonotic implications. since most of the public attention is given to the nphp it receives the bulk of the resources, while nahp components receive little attention and few resources. furthermore the nahp has many mandates and also is woefully underfunded. a good example of the imbalance of resource allocation is evident in the current activities related to the global occurrence of highly pathogenic avian influenza (hpai). far more resources have been given to the detection and control of spread of hpai h n in human populations with relatively limited resources dedicated to the animal side, even though the spread of the infection can be prevented in human side if the focus is on the animal side. in a country such as the usa, there is the need for a parallel and sound relationship between nphp and nahp. an awareness system indicating the link between these two national systems must be shared with decision makers. this system would require animal health authorities and other interested parties such as the animal industries to have intensive and effective communications with decision makers and the public. the livestock industry, veterinary professionals, animal health authorities and other related sectors should attempt to build bridges with their public health counterparts by explaining the value of nahp for the well-being of society. the form of such collaboration requires comprehensive understanding of the role of each of these sectors in building a reliable, effective, and practical nahp. unfortunately, there is limited understanding of the role of each of these sectors with their counterparts. therefore, records of successful past and current accomplishments of nahp should be collected and presented to appropriate professional societies and authorities. the broad aspect of public health and preventive measures should also be emphasized. any focus on selected zoonotic diseases coupled with a speculative and less scientific approach should be avoided as much as possible. the discipline of veterinary epidemiology can be effective only if it is based on a solid understanding of its scientific principles and implemented by people who are well trained. understanding the concepts of veterinary epidemiology and its tools are mainly a result of research and education. the implementation of specific approaches and tools requires training and application in natural as well as field conditions. most of the graduate programs currently available require substantial on-campus residency periods which often make it difficult for public sector veterinarians to undertake them. therefore, it would seem appropriate to explore the possibility of establishing training programs which require short intensive periods with the focus on animal health events of contemporary importance that are of interest to the audience. distance education and working in the field with selected 'mentor' epidemiologists can enhance this type of training. this type of approach to training has several advantages for building a sound infrastructure for animal health programs. it allows opportunities for training in a way that more fully utilizes the talents of the veterinary epidemiologists already employed by the public sector. it will build a cadre of veterinary epidemiologists who can contribute a harmonized approach to national, regional, and global animal health programs. the training program will also be a major contributor in solving the most current emerging disease since it can deal directly with that disease. in addition, the field activities associated with this training program can be part of the regular public sector activities and thus serve ongoing needs. highly pathogenic avian influenza (hpai) h n asia strain is a growing problem in animal industries throughout the world, and there is the added threat to human health in the case of a human-adapted strain which might cause a pandemic. worldwide, countries are preparing and implementing response plans (efsa, ) . the u.s. government through the department of state, department of human health services, and department of agriculture has contributed to several initiatives and projects to combat this disease in both humans and animals. for example, usda-animal plant health inspection services-veterinary services has been engaged in the delivery of technical capacity to various countries. traditionally, aphis has supported the training of epidemiologists within the domestic service because it recognizes the value of these scientists in the development of strategies to combat diseases, to evaluate risk, and in many cases to form the basis for field veterinarians to detect, control and eradicate outbreaks of disease. to these same ends, aphis conducted a series of four regional epidemiology workshops in and for working-level epidemiologists of national veterinary services. these workshops were regionally convened: in bangkok for countries of asia; in vienna for the countries of eastern europe, the middle east and countries of the former soviet union; in cairo for the countries of north and east africa; and in dakar for the countries of west africa and southern africa. the criteria for selection of these countries were based on greatest need, greatest number of human cases, lack of veterinary infrastructure, and possibly additional criteria. indonesia, egypt, nigeria, turkey, and vietnam were identified as either a priority country, or a country at risk for infection where an opportunity existed to train epidemiologists. in each of these countries, a training program on epidemiological concepts, field investigation and detection of hpai cases was conducted. in addition, two sessions for selected participants were held in fort collins, co, usa with an emphasis on the national surveillance system and implementation of a comprehensive national plan for the detection of hpai, emergency planning, geographic information systems, and incident command system (ics) application to hpai control. the value and effectiveness of these training sessions have already been observed. animal health officers who have gone through these sessions have already been engaged in several of the following activities as a result of their training and exposure to alternative approaches: revision of a national surveillance plan to better reflect sound epidemiological approaches (fao-egypt plan). establishment of a more reliable case definition for investigating and reporting ai cases (fao report). establishment of a national professional network for the purpose of consolidating efforts to constrain the extent of ai (nigeria experience). change of the concept of biosecurity from the presence or absence to a continuum of efforts to prevent the introduction of the infection into premises or regions (indonesia experience). revitalization of epidemiological units as part of the government veterinary services (egypt experience). during the last two decades, the largest hurdle facing animal health has been the lack of resources available to combat several emerging and re-emerging infectious diseases. due to recent events, particularly those with public health implications, more resources than ever are currently being directed toward pressing animal heath challenges. the available funds, however, are mainly directed at specific high-profile infectious diseases instead of animal diseases in general. nevertheless, these resources provide an excellent opportunity to improve the infrastructure of organizations involved in national and global animal health programs. the emergence of diseases that receive the attention of the public and of policy makers requires technically reliable disease investigation and case findings. there also are requirements for a science-based approach to trade and assessment of risk (i.e., no longer zero risk). furthermore, international financial institutions have more involvement in shaping government veterinary services and have several requirements to justify plans of action. veterinary epidemiology has been a major discipline in supporting and improving national as well as global animal health programs. this discipline, however, should not be considered as an extension of the human public health sector or human epidemiology. veterinary epidemiology is unique in its approaches and anticipated issues to be solved. the discipline's contribution to reducing the impact of global infectious animal diseases is significant but has had limited recognition. veterinary epidemiologists are faced with several challenging questions in determining their role at the macro-level of animal health programs. answering these questions requires a detailed assessment of approaches for designing scientifically sound national animal health programs that include surveillance, prevention strategies, and response plans. the planning of training and outreach sessions is an essential component for the promotion and implementation of sound animal health programs. veterinary epidemiology is currently in its golden age in terms of its growth and encouragement of scientific approaches. the use of multilevel models to evaluate sources of variation in reproductive performance in cattle animal health and welfare aspects of avian influenza and the risk of its introduction into the european union poultry holdings-scientific opinion of the panel on animal health and welfare of the european food safety authority sewage effluent: likely source of salmonella entritidis phage type infection in a commercial chicken layer flock in southern california veterinary epidemiology: principles and methods veterinary epidemiology: challenges and opportunities in research epidemiology in veterinary practice the current epidemiological revolution in veterinary medicine. part i the current epidemiological revolution in veterinary medicine. part ii dr. m.d. salman does not have any conflict of interest. key: cord- -xhem l authors: tulchinsky, theodore h. title: bismarck and the long road to universal health coverage date: - - journal: case studies in public health doi: . /b - - - - . - sha: doc_id: cord_uid: xhem l the sustainable development goals (sdgs) state that all united nations member states have agreed to try to achieve universal health coverage by . this includes financial risk protection, access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. universal health coverage (uhc) means inclusion and empowerment for all people to access medical care, including treatment and prevention services. uhc exists in all the industrial nations except the us, which has a mixed public-private system and struggles with closing the gap between the insured and the uninsured population. middle- and low-income countries face many challenges for uhc achievement, including low levels of funding, lack of personnel, weak health management, and issues of availability of services favoring middle- and upper-class communities. community health services for preventive and curative health services for needs in populations at risk for poor health in low-income countries must be addressed with proactive health promotion initiatives for the double burden of infectious and noncommunicable diseases. each nation will develop its own unique approach to national health systems, but there are models used by a number of countries based on principles of national responsibility for health, social solidarity for providing funding, and for effective ways of providing care with comprehensiveness, efficiency, quality, and cost containment. universal access does not eliminate social inequalities in health by itself, including a wide context of reducing social inequities. understanding national health systems requires examining representative models of different systems. health reform is necessarily a continuing process as all countries must adapt to face challenges of cost constraints, inequalities in access to care, aging populations, emergence of new disease conditions and advancing technology including the growing capacity of medicine, public health and health promotion. the growing stress of increasing obesity, diabetes, and other chronic diseases, requires nations to modify their health care systems. learning from the systems developed in different countries helps to learn from the processes of change in other countries. the world health organization (who) defines a health system as: "the people, institutions and resources, arranged together in accordance with established policies, to improve the health of the population they serve, while responding to people's legitimate expectations and protecting them against the cost of ill-health through a variety of activities whose primary intent is to improve health. it is a set of elements and their relationship in a complex whole, designed to serve the health needs of the population. health systems fulfill three main functions: health care delivery, fair treatment to all, and meeting health expectations of the population." who's world health reports ( , , ) focused on health systems financing and management in the search for universal health coverage. under the globally endorsed sdgs, universal health coverage (uhc) is designated goal (health and wellbeing), target . : "achieve universal health coverage (uhc), including financial risk protection, access to quality essential health care services, and access to safe, effective, quality, and affordable essential medicines and vaccines for all". box . outlines who building blocks for uhc. universal access is a means of assuring that the economic barrier to health care is mostly if not completely removed for the total population and may lead to increased access to medical and hospital services for those previously excluded. while uhc increases access to medical care and health indices, it does not, of itself, guarantee achievement of many important health targets. allocation of resources is an even more fundamental problem to address the needs of those with the highest risk of early disability or avoidable premature death. a system of national health must be able to allocate resources to meet those needs and must not simply be a payment system for doctors and hospitals. changing demographics, medical advances and epidemiological challenges including social and health inequalities also be addressed with high priority. this case study provides the background and experience of the development of uhc over the past century and a half, with lessons learned for consideration in how-and what-is done to achieve this goal. most industrialized countries have implemented national health programs such as health insurance systems or national health services. each system developed in the political, social, and historical context of the country-and continues to evolve. medium-and lowincome countries are also struggling to achieve universal access to care and health for all by expanding primary health care and social security plans which provide benefits to workers and for certain vulnerable populations-primarily mothers and children. as they move up the scale of economic development, developing countries must also address the problem of how to decrease morbidity and mortality, achieve equity in access to health care, and expand the funding basis for health care through national health insurance. some countries experience rapid economic development, but lag behind in directing increased national wealth towards improving health status. this is often due to a lack of focused political commitment, trained policy analysts, and cultural adaptation to the crucial importance of public health. each national health system has its own characteristics and challenges. systems management requires continuous evaluation based on welldeveloped information systems, trained health management personnel, societal involvement through all levels of government, as well as the private sector, professional organizations and advocacy groups. there is no defined "gold standard" plan for providing universal access to health care that is suitable for all countries. each country develops and modifies a program of national health appropriate to its own political and cultural needs and available resources. however, there are evolving patterns in health care organization, so that networking within and between countries ensures that they can-and do-learn from one another (box . ). barriers to necessary health care can be geographic, ethnic, cultural, social, lack of information and awareness, psychological, financial, and poverty. removing financial barriers to care is necessary and constructive, but not sufficient to address the health problems of individuals and of a society. equity in financial access with universal coverage is vital to population and individual health since anyone can have serious illness at any time. but equally important, long-term preventive care and health promotion are essential to good population and individual health standards. inequities exist in all societies, but many countries have successfully reduced these by poverty alleviation, job creation, education, and other programs that reduce interregional, socioeconomic, and demographic differences in health. special attention to high-risk groups in a population is essential. groups at-risk may be based on age, gender, ethnicity, genetic legacy, occupation, risky lifestyle, location of residence, religion, sexual orientation, economic status, or other factors that increase susceptibility to disease, premature death, or disability. services must be based on need and not only demand, which can escalate costs by over-servicing. health systems planning needs to promote access to patient care, but also those services that reach the entire population, especially people at high risk who are often least able to seek and access appropriate care. a program that provides equal access for all may not achieve the objective of better health for the population unless accompanied by other box . key elements of national health systems . a tradition of government and nongovernmental initiatives to improve health of the population. . public administration and regulation; public-private partnerships. . intersectoral cooperation with education, social services and the private sector. . demographic, economic, and epidemiologic monitoring. . health targets monitored with accessible data systems. . public health programs, including strong elements of health promotion. . universal coverage by public insurance or service system. . access to a broad range of health services. . strategic planning for health and social policies. . monitoring health status indicators. . recognition of special needs of high-risk groups and related issues. . portability and accessibility of benefits when changing employer or residence. . efforts to reduce inequity in regional and socio-demographic accessibility and quality of care. . adequacy of financing. . cost containment. . efficient use of resources for a well-balanced health system. . consumer satisfaction and choice of primary care provider. . provider satisfaction and choice of referral services. . promotion of high-quality service. . promote patient and staff safety. . comprehensive public health and health promotion programs. . comprehensive primary, secondary, and tertiary levels of medical care. . well-developed information and monitoring systems. . continual policy and management review. . promotion of standards and accreditation of services, professional education, training, research. . governmental and private provision of services. . decentralized management and community participation. . assurance of ethical standards of care for all. . conduct epidemiological, basic sciences and health systems research. . preparation for mass casualties from disasters and terrorism. important governmental, community and personal self-care activities. these include enactment and enforcement of environmental and occupational health laws, food safety, nutrition standards, clean water, improved rural care, higher educational levels, and provision of health information to the public. additional national programs are needed to promote health generally and to reduce specific risk factors for morbidity and mortality. responsibility for health lies not only with medical and other health professionals, but also with governmental and voluntary organizations, the community, the family, and the individual. individual access to an essential "basket of services" as a prepaid insured benefit is fundamental to a successful national health program. each country addresses this issue according to its means and traditions, but cost-effective evidence-based methods of meeting a countrys epidemiologic and demographic needs should be prioritized. coverage and payments for heart transplantation, for example, may be beyond the means of a health system, but early and aggressive management of hypertension, smoking, poor diet, physical inactivity, and rapid care for acute myocardial infarction are effective in saving lives at modest cost and containing the need for more intrusive health care interventions. prevention is cost-effective and should be integral to the development of service priorities within the insured benefits with incentives included in the "basket of services". globalization affects health systems around the world not only in the ease of spread of infectious diseases, but in increased access to modern preventive, diagnostic, treatment modalities. access to antiretroviral drugs has dramatically changed the face of hiv/aids globally, including in low-income countries with support of international and bilateral donors. the same is true for vaccines, including the mmr (measles, mumps, rubella, doses), hib (hemophilus influenza b), rotavirus, pneumococcal pneumonia and hpv (human papillomavirus) vaccines, which will save millions of children's lives and foster well being in the coming decade. information technology, migration of medical professionals, and internalization of educational standards are all global health issues affecting national health systems. health systems in all countries are facing common problems in population health, with rising population age, hypertension, obesity and diabetes prevalence, and rising health care costs. health systems research capacity is important in each country as it attempts to cope with rapid changes in population health and individual health needs with limited resources. development of research capacity enables improved capacity of decision-makers for informed, cost-effective decisions. in developing countries, low levels of funding for health in general-including research-impede evidence-based health system development and training of the new health workforce. strengthening reporting systems of data aggregation, as well as economic and epidemiologic analysis, are vital for health policy and management. national health systems from germany, uk, canada, us and russia are presented here as representing major models of organization. these organizational models influence health care system formulation in both developing and developed countries, as well as for countries restructuring their health services. health care systems and financing are under pressure everywhere, not only to assure access to health for all citizens, but also to keep up with advancing medical technology, and contain the cost increase at sustainable levels. because a health system is judged by more than its cost and measure of medical services, indicators of health status of the population, as well as morbidity and mortality are vital and should be available for the public through community organizations and the media. this topic has developed a complex terminology of its own. the world health organization (who) helps development of national health systems as shown in box . . universal health coverage is defined as ensuring that all people have access to needed health promotion, preventive, curative and rehabilitative health services, of sufficient quality to be effective, while also ensuring that people do not suffer financial hardship when paying for these services. g good health is essential to sustained economic and social development and poverty reduction. g access to needed health services is crucial for maintaining and improving health. g at the same time, people need to be protected from being forced into poverty because of the cost of health care. g a well-functioning health system working in harmony is built on having: trained and motivated health workers; a well-maintained infrastructure; a reliable supply of medicine and technologies; backed by adequate funding; strong health plans; evidence-based policies. who assists in creating resilient health systems by supporting countries to: g "develop, implement, and monitor solid national health policies, strategies and plans. g assure the availability of equitable integrated people-centered health services at an affordable price. g facilitate access to affordable, safe, and effective medicine and health technologies. g strengthen their health information systems and evidence-based policy-making, and to provide information and evidence on health-related matters." source: world health organization. health systems. available at: http://www.who.int/ healthsystems/about/en/ (accessed may ). health systems are meant to improve health and quality of life, as measured by quantitative and qualitative methods. the human development index (hdi) provides a standard method of comparison which combines many health and social indices into a summary figure for social development of countries. these include life expectancy at birth, gross domestic product (gdp) per capita, child mortality, education and others. table . shows life expectancy, still a valued health status indicator, for some industrialized, mid-level, and developing countries. comparisons between countries health indicators are useful to portray relative international health status among nations. the foundations of public responsibility for health care systems go back to ancient greece and rome where city states employed municipal doctors to service the poor and slaves. in the medieval and renaissance periods, monasteries and nunneries provided charitable care to the poor while professional guilds provided prepaid medical care and other social benefits to members and their families. these later evolved into the friendly (benevolent) societies, as mutual benefit programs that provided for burials, pensions, and payment for health services for members. in the twentieth century, these developed through collective bargaining into health insurance plans through private or professionally sponsored insurers, and labor unionÀsponsored health plans. governmental responsibility for health systems evolved in public health and health protection systems in the nineteenth and twentieth centuries and continues to evolve to face new challenges as well as preventive and treatment capacities. the health systems described highlight the unique and common features of national health systems in the search for "health for all", and policies for making health a priority in resource allocation, policy priority for human rights, and for socioeconomic development. figure . indicates the À trends in total health expenditures as percent of gross domestic products of selected countries in the european region of who. german and swedish expenditures rose to between % and %, in the united kingdom to over % while israel is relatively stable under % and the russian federation expenditures rose to % of gdp. germany's health care system today is characterized by participation as well as sharing of decision-making powers between the states (la¨nder), the federal government and civil society organizations. since , statutory health insurance (shi) has been mandatory for all citizens and permanent residents pay a uniform contribution of . percent of their income (gesetzliche krankenversicherung) with sickness funds (krankenkassen, january ). shi covers percent of the population, who have the right to choose their preferred sickness fund for a comprehensive range of services. the sickness funds are linked to associations of physicians accredited to treat patients covered by shi. private health insurance (phi) covers percent of the population for designated groups such as civil servants. others ( %) such as the military are included in other specific governmental programs. since the s financial incentives are being introduced to improve quality and efficiency of care along with beneficiaries right to choose between sickness funds increasing competition and a market orientation. hospitals are paid by diagnosis related groups (drgs)-i.e., payment by diagnostic category rather than hospital length of stay, adopted from us experience. physicians are paid by a capitation system-i.e., a fixed payment for each person registered for care with a doctor for a fixed period of time (as opposed to fee-for-service) in the doctor's medical associations. longterm care is covered by a federal mandatory program. germany expends . percent of gdp ( ) on health, one of the highest levels among eu members, with percent from public sources and percent privately sourced. in , germany had . acute care beds per , beds per population, nearly percent above the rate for the original eu countries ( . per , ). of these, percent of beds were in publicly owned, percent in private nonprofit, and percent in private for-profit hospitals. busse et al. ( ) describes reforms since its founding in gradually achieving universal coverage. the system is also seeking greater cost effectiveness as compared to neighboring countries. in europe, many countries developed taxation or social security models based on the bismarckian approach, with compulsory contributions by workers and their employers to a national social security system. this then financed approved services usually paid through private medical practice with fee-for-service payment. many european countries and japan gradually developed similar forms of compulsory health insurance for workers and their families following world war i, or later after world war ii, expanding to universal coverage health insurance systems. this model is used in france, belgium, the netherlands, japan, switzerland, and latin america as well as post-soviet health reforms and countries of eastern europe (cee). the israeli system, adopted in , based on the bismarckian model is mandatory national health insurance in which everyone must choose one of four long-standing sick funds now called health organizations. they compete for members, and are paid a per capita sum for which they are obliged to provide comprehensive services including hospital, primary care, and preventive services. the services improved vastly under national health insurance, with services kept up to date with annual additions to the statutory "basket of services." health statistics show israel as among the top countries for life expectancy, with rapidly falling mortality from strokes, coronary heart diseases, and cancers. consumer satisfaction is high, maternal and child health are stressed, a low hospital bed to population ratio, while health expenditures are relatively modest and a stable per capita health expenditure just under eight percent of gdp (lancet ). william beveridge was born in in bengal, india, where his father was a judge in the indian civil service. he trained as a lawyer coming to prominence in the british liberal government of À when he advised david lloyd george (chancellor of the exchequer from to , prime minister from to ) on old age pensions and national insurance. in , initiated by lloyd-george, influenced by the german compulsory health insurance scheme, the liberal government of great britain introduced the national health insurance act. it was compulsory for all wage earners between and years of age. this was a two-part plan based on a worker and employer contributory system for both unemployment insurance and for medical care for workers and their families. administration was through approved mutual benefit societies (the friendly societies), some based on insurance companies, and others by professional associations and trade unions. general practitioner services were paid on a capitation basis rather than a salary, preserving their status as self-employed professionals. initially this plan covered one-third of the population increasing to half by , however there was disruption due to mass unemployment during the great depression starting in and continuing to the late s. in the early days of world war ii, the british government established a national emergency medical service for hospitals in preparation for the anticipated large-scale civilian casualties that were expected during the blitz bombing by nazi germany. this established national health planning and rescued many hospitals from near bankruptcy due to the effects of the great depression in the united kingdom (uk). during world war ii, at the behest of prime minister winston churchill, beveridge developed a postwar social reconstruction program. the beveridge report of , social insurance and health services, outlined the concept of a future welfare state including a national health service, placing medical care in the context of general social policy for the total population. the wartime government coalition approved the principle of a national health service, which had wide public support, despite opposition from the medical association. in , the newly elected labour government of clement attlee took up the recommendations of beveridge to introduce the national insurance act ( ) as a comprehensive system of unemployment, sickness, maternity, and pension benefits funded by employers, employees and the government. the national health service (nhs) act was instituted in under the leadership of aneurin bevan, against continued opposition from medical organizations, as a universal state health service in britain. the nhs provides a nationally tax-based financed, universal coverage system providing free care by general practitioners, specialists, hospitals, and public health services. this includes diagnosis and treatment of illnesses at home or in hospital, including dental and optometric care. the original nhs structure was divided into three separate services: hospital, general practitioner, and community health services. the hospital and specialist services were under the authority of regional boards. general practitioners worked under national contracts, and community health services, such as public health, home nursing and health visitors, midwives, maternal-and child care, came under the control of the county and city local authorities. all units reported to the minister of health and his staff. the hospital bed supply in the uk in was just under half the rate in france and one third of the rate of beds in germany per , population. hospital based specialists are salaried but highly independent; general practitioners ran their own practices and provided the foundation of the nhs system. over time, this tripartite structure evolved to some degree of integration of gp and community health services, along with hospitals under hospital trusts reporting to regional health authorities. the nhs, with periodic reforms, is still in place in the uk and well accepted by the population and-over time-even by conservative governments and by the medical profession. there are differences between the nhs systems of the uk: england, scotland, wales and northern ireland each operate their own nhs, albeit with funding and structure of the central nhs. regional disparities in health indicators still exist despite changes in funding giving greater resources within regions (north-south divide) of england; each of the four has their own, policy directions. social class and geographic inequities in health within the nhs have been recognized since the s with a series of reports and analyses showing large gaps in life expectancy, avoidable (i.e., preventable) mortality between the south and north of england and even more so with scotland and significantly poorer health indicators. the marmot report on inequalities from indicated the scope of the problem: "people living in the most deprived neighborhoods will on average die seven years earlier than people living in the richest neighborhoods. even more disturbing, people living in poorer areas not only die sooner, but spend more of their lives with disability-an average total difference of years. the review has estimated the cost of health inequalities in england: productivity losses of d À billion every year; lost taxes and higher welfare payments in the range of d À billion per year; and additional nhs healthcare costs well in excess of d . billion per year." the "beveridge model" is a term used for the national health service model, which has since been adopted by many european countries and should be regarded as a strong model for countries reforming their universal health care systems, such as spain and italy. the scottish nhs diverges from the central english nhs in addressing inequalities by a focus on the health sector as the sole responsibility for reduction of inequalities. the english nhs and other government agencies see the problem more broadly and adopted poverty-fighting measures with some success in improving mortality and morbidity social and health disparities since . the nhs system remains generally popular in providing health security for all, and reaching good outcome measures despite regional inequities. no change of governing political party has led to dismantling the nhs for a privatized health system over the seven decades since its inception. canada: national health insurance tc (tommy) douglas was born in falkirk, scotland and immigrated at the age of with his working class family to winnipeg, manitoba, canada. he developed osteoarthritis and the doctors were going to amputate his leg as the family lacked funds for long-term medical care. his leg was saved by a senior surgeon who refused the amputation. this made tommy a lifelong advocate and fighter for publicly administered, universal health care for all. he became a baptist minister and entered politics winning the saskatchewan general election of for the ccf party in a massive victory. it was the first democratic socialist government elected in north america. he held the office for years, during which time he pioneered many major social and economic reforms. canada (population . million) is a federal state and a constitutional monarchy with parliamentary systems at national and provincial/territorial levels. health is primarily a provincial responsibility, but federal funding and standards play an important role in the canadian health system. local authorities also carry out many primary public health services including sanitation, water safety, and supervision of food safety, among other responsibilities. the provinces/territories are responsible for the funding of hospital, community, home and long-term care, as well as mental and public health services. starting in the s, federal grants-in-aid were given to the provinces/ territories for categorical health programs, such as cancer and public health services programs. since the sars (severe acute respiratory syndrome) epidemic in , the canadian federal government has increased its capacity in public health with a new federal department of public health, regional laboratories and encouragement of many schools of public health across the country. canada's national health program evolved as a system of provincial health insurance with federal government financial support and standards. initiatives for national health insurance in canada go back to the s, but definitive action occurred only after world war ii. the federal government regulates drug and medical device safety, funds research and provides services to the native indigenous population groups, the military, rcmp (royal canadian mounted police) and federal prison inmates. services for veterans were later transferred to provincial medicare programs. the development of national health insurance was largely due to the bitter experience of the great depression of the s, a strong agrarian cooperative movement, and the collective wish for a better society following world war ii. in , the social democratic cooperative commonwealth federation (ccf) party under the leadership of tommy douglas formed the government of saskatchewan, a large wheat-growing province of one million people on the western prairies. the national universal health insurance program evolved from the provincial initiatives led by tommy douglas, now considered "the father of canada's universal medicare plan." douglas established the saskatchewan hospital insurance and diagnostic services act in under provincial public administration. in a federal cost-sharing formula began providing approximately percent cost-sharing with greater levels of funding going to the poorer provinces. by , all provinces and two territories had implemented hospital insurance plans, in a twotiered national health insurance plan-i.e., universal provincial/territorial health plans with federal standards and cost-sharing. in , again in saskatchewan, the medical care insurance plan (medicare) was implemented after a bitter doctors' strike. in , the federal government appointed a royal commission on health services (the hall commission) which in recommended adoption of the saskatchewan model across the country with federal support and standards. the saskatchewan plan was rapidly followed by similar plans in other provinces encouraged by generous federal costsharing. the federal government cost-shares provincial and territorial programs. provinces/territories must adhere to the standards of the canada health act ( ), which defines services to be covered for hospital, diagnostic, and physician services. there is federal funding support for provincial/territorial public health, long-term care, home care and community mental health services. this federal legislation was expanded to provide co-funding for provincial/territorial medicare plans, which over a short period brought all canadians into provincially administered systems of publicly financed health care, while retaining the private practice model of medical care. hospital care is provided mostly through non-profit, non-governmental hospitals. developed over the period À , the provincial/territorial health insurance plans were promoted by federal governmental cost-sharing, political support, and national standards. the plans were initially financed by taxation and premiums, but later solely by general tax revenues with federal support under the canada health act of . federal standards required the provincial plans to be: publicly administered; comprehensive in coverage of health services; universal; portable across provinces; and, accessible without user fees. federal reimbursement to the provinces/territories initially covered percent of national average medical care expenditures per capita and percent of the actual expenditures by each individual province. this provided higher-than-national-average rates of support to poorer provinces as well as portability between provinces/territories. by , all provinces had implemented such plans, and a high degree of health services equity was achieved across the country. care is provided by private medical practitioners on a fee-for-service basis under negotiated medical fee schedules with no extra billing allowed. hospitals are operated by nonprofit voluntary, religious organizations or municipal authorities, with payment by block budgets. per capita spending on health in canada is relatively modest in comparison with that of the us, but above oecd averages. public spending as a percent of total health expenditures is close to the oecd average (see box . ). this medicaretype plan was later adopted in a number of other countries including australia. medicare is still popular in canada, with support from all political parties and by most medical professionals. medicare and federal cost-sharing weighed in favor of the poorer provinces, allowing these to catch up in health care services and standards with the richer provinces. the canadian health program differs substantively from those of the united kingdom and the united states. health systems are important in the political and cultural life of a country. each within its own tradition is attempting to ensure population health through public or private means, to constrain the rate of cost increases. comparisons using various health indicators can be controversial, but the canadian universal health service or insurance coverage seems to have improved the health status of the population more rapidly than similar indicators for the total us population, but not necessarily for all segments of the population. after decades of focus on developing national health insurance, canada became a leading innovator in health promotion prevention (see chapter ) . the canadian health program established universal coverage for a comprehensive set of health benefits without changing the basic practice of medicine from individual medical practice on a fee-for-service basis. poorer provinces were able to use the federal cost-sharing mechanism to raise standards of health services, and a high degree of health services equity was achieved across the country. rapid increases in health care costs led to a review of health policies in (the federalÀprovincial committee on the costs of health services). the resulting report stressed the need to reduce hospital beds and develop lower-cost alternatives to hospital care, such as home-based care and long-term care. federally-led initiatives during this period extended coverage to include home-based care and long-term nursing home care, while restricting federal participation in cost-sharing to the rate of increases in the gross national product (gnp). since then, many provincial and federal reports have examined the issues in health care and recommended changes in financing, cost-sharing, hospital services, development of primary care, and other community services. in , a new approach to health was outlined by the federal minister of health, marc lalonde, in a landmark public policy document, a new perspective on the health of canadians. this report described the health field theory in which health was seen as a result of genetic, lifestyle, and environmental issues, as well as medical care itself. as a result, health promotion became a feature of canadian public policy, with the objective of changing personal lifestyle habits to decrease cross-cutting risky behaviors such as smoking, obesity, and physical inactivity. the pioneering work in nutrition from the national nutrition survey published in led to the adoption of federal mandatory enrichment regulations for basic foods with essential vitamins and minerals. this and other initiatives in the s led to the ottawa charter on health promotion (see chapter ) , which has had a global impact with the foundation of health promotion as a crucial new aspect of public health and health system policy. the canadian health system being primarily the responsibility of the provinces/territories had a down side. during the sars pandemic of , the provinces dealt with it and were found to be lacking strong public health institutions adequate to the task. following high level reviews of the sars episode the federal government established a cdc-like institution, regional laboratories capable of infectious disease challenges and eight schools of public health across the country to ensure continuing development of a competent public health workforce. universal health care needed to be supplemented by introduction of lalonde-initiated health promotion and equally so a strong microbiologic public health component to ensure rapid and competent responses to new emerging health challenges. how does the canadian public view the universal public single payer medicare run by the provinces with federal guidelines and cost-sharing program? despite complaints, mostly from us sources, the canadian public appreciates their health protection very much. in , the canadian broadcasting corporation (cbc) television conducted a program over many months called "the greatest canadian," with candidates and advocates. this included a call to all people in canada to nominate their greatest canadian. canadians from coast to coast were asked to vote and chose tommy douglas, known as the "father of medicare" and selected by national polling as "the greatest canadian of all time." the canadian public is proud of their medicare plan, and appreciates the security and social protection as a great achievement for everyone in the country. australia, taiwan, and south korea have adopted national health insurance systems similar to the canadian model. the us (population million, gdp per capita usd $ , in ) has a system of government based on the federal constitution, with states each having its own elected government. the constitution gives primary responsibility for health and welfare to the states, while direct federal services are provided to armed forces, veterans, and indigenous (native) americans. the federal government has established a major leadership role in national health by the development of national standards, national regulatory powers, funding, and information systems. the federal level has many governmental structures for regulation of food, drugs, and environment, as well as for research, public health services, training programs and health insurance systems for the elderly and the poor. the us has the world's costliest health care system with over percent health insurance coverage, but universal access remains elusive, and population health indicators are well below many less-wealthy countries. however, the us has through trial and error experimentation made major contributions to the content and organization of public health systems, which are important for strengthening health systems in medium-and low-income countries as well as influencing countries with universal health systems (see chapter ) . clearly, the us can learn from other countries as well (see box . ) . in , the federal government established the us marine hospital service to provide hospitals for sick and disabled merchant seamen. this later became the uniformed us public health service commissioned corps (usphs) headed by the surgeon general ( ). services were added for native americans, military personnel and their families (through the veterans affairs department), the food and drug administration (fda), the national institutes of health (nih), the centers for disease control (cdc) and many other world class federal programs of research, service and teaching. other departments and legislation were added to promote nutrition and hygiene, establish state, municipal, and county health departments, and regulate drugs and health hazards. in , the sheppard-towner act established the federal children's bureau that administered grants to assist states to operate maternal and child health programs. from the s, labor unions won health insurance benefits through collective bargaining, which became the main basis for prepayment for health care in the united states until today. in , the committee on the costs of medical care recommended a universal national health program. this initiative was set aside during the great depression of À . the us social security act (ssa) of was introduced by president franklin d. roosevelt as part of the "new deal" to alleviate the mass suffering of the people during this very traumatic period in the us (and europe). the ssa was intended to include national health insurance, but this part of the ssa was set aside largely due to strong opposition of the insurance industry and the organized medical profession. the ssa provides financial benefits for widows, orphans, and the disabled, as well as pensions for the elderly, and provided a base for future reform including health insurance. with the outbreak of world war ii, a significant percentage of eligible military recruits were found unfit for compulsory service due to preventable health conditions. this, and the wish to maintain population health, led president roosevelt to initiate regulations in for fortification of "enriched" foods reaching a majority of the population including salt with iodine, flour with iron and vitamin b complex, and milk with vitamin d. during world war ii ( À ), governmental health insurance was provided to many millions of americans serving in the armed forces, along with their families. at the same time, health benefits through voluntary insurance for workers were vastly expanded in place of wage increases and this became the major method of prepayment for health care for a majority of the population. at the end of the war, millions of veterans were eligible for health care through the veterans administration (va), which established a national network of federal hospitals and primary care services. in , president truman attempted to bring in national health insurance, but the legislation (the wagner-murray-dingell bill) failed in the us congress. one section of the bill was approved, enabling the federal government to initiate a program to upgrade country-wide hospital facilities, while limiting the beds to population ratio, under the hill-burton act (see chapter ) . legislation also provided massive federal funding for the newly established national institutes of health (nih) to fund and promote research to strengthen public and private medical schools, teaching hospitals, and research facilities. in , president truman established the federally-assisted school lunch program through the department of agriculture bringing nutritious meals to many (millions increasing from million in to million in ) of school children throughout the us. in the s, the federal government also established the centers for disease control and prevention (cdc) and increased assistance for state and local public health activities and encouraged expansion of schools of public health across the country. in the us during the s through to the s, rapid health cost increases were attributed to many factors including the lack of a national health insurance mechanism. the plethora of health insurance systems fostered high costs and restrictions on access due to pre-existing conditions. other factors for rapid cost increases included an increasing elderly population, high levels of morbidity in the poor population, the spread of aids, rapid innovation and costly medical technology, specialization, high laboratory and diagnostic imaging costs, and large-scale public investment in medical education, research and health facility construction. the us system includes a mix of public health insurance and service programs (medicare, medicaid, veterans administration, indian health services, and military health coverage) which provide for a significant part- . percent in -of the us population. however, the majority ( %) is covered by the private insurance industry through employer-employee contracts which developed rapidly as the dominant health insurance sector with minimal government regulation. the cost of private health insurance to employers included in labor contracts of their employees and pensioners has become very high. in , general motors reported to a senate hearing that the cost of health insurance per car produced was double the direct cost of labor and more than the cost of steel per car. this impinged on competitiveness in price with for example with japan which has a successful universal governmental health insurance plan with public-private mix of services. the affordable care act (aca) introduced by president barack obama in brought some million previously uninsured persons into public and private insurance, increased governmental regulation to ensure fair pricing and payment and, especially, to abolish the past abuses of the "pre-existing condition" exclusions from insurance. other equally important factors were high levels of preventable hospitalization, institutional orientation of the health system, high administrative costs due to multiple private billing agencies in the private insurance industry, high incomes especially for specialist physicians, and high medical malpractice insurance costs. the pressure for cost constraint came from government, industry, and the private insurance industry. (see chapter ). private medical practice, with payment by fee-for-service, was the major form of medical care in the us until the s. most hospitals were operated through a mix of nonprofit agencies, including federal, state, and local governments, and voluntary and religious organizations, but a growing percentage are privately owned, for-profit (from . % of beds in to . % in ). in an effort to contain costs, the diversity of insurance systems promoted experimentation with organizational systems. health maintenance organizations (hmos) and other forms of managed care systems grew rapidly to become the predominant method of organizing health care in the united states. prepaid group practice (pgp) originated from private companies contracting to provide medical care, especially in remote mining camps and construction sites. in the s, new york city sponsored the health insurance plan of greater new york to provide prepaid medical care for residents of urban renewal and low-income housing areas. this was later extended to include organized union groups such as municipal employees and garment industry workers. pgp became best known in the kaiser permanente network developed for workers of henry j. kaiser industries, at the boulder dam and grand coulee dam construction sites in the s. kaiser permanente health plans now provide care for millions of americans in many other states. initially opposed by the organized medical profession and the private insurance industry, pgp gained acceptance by providing high-quality, less-costly health care. this became attractive to employers and unions alike, and later to governments seeking ways to constrain increases in health costs. since the s, the generic term health maintenance organization (hmo) was promoted by the federal government in the hmo act by president richard nixon in . hmos, which operate their own clinics and staff (i.e., the staff model), or through contracts with medical groups as preferred provider organizations (ppos), have become an accepted, if criticized, part of medical care in the united states and an important alternative to fee-for-service, private practice medicine. in , . million americans were registered in hmo plans or . percent of the total us population. in recent years, the terms accountable care organizations (aco), patient-centered medical home (pcmh) and population health management system (phms) have come into wide use to denote organizations that take responsibility for comprehensive care for enrolled patients, with payment based on a form of capitation rather than fee-for-service. acos are present in all states, washington, dc, and puerto rico, with the population covered increasing from . million in to . million in . the aco comes in different models, but many include a hospital base and may be linked to independent practice associations (ipas), and specialty groups, or hospital medical staff organizations, or in a network of hospitals linked with other providers as an organized delivery system. these are not-for-profit group practices led by doctors who are salaried and subject to rigorous annual professional review. this model may be adaptable on a wider scale to improve quality and cost effective care to improve health of americans. in , a prospective payment system, called diagnosis-related groups (drgs), was adopted for medicare, to encourage more efficient use of hospital care, with payment by categories of diagnosis. the drg is a classification system, for inpatient stays, categorizing possible diagnoses into more than major body systems and subdivides them into almost groups for the purpose of medicare reimbursement. this replaced the previous system of paying by the number of hospital days, or per diem or by itemized billing which encouraged longer hospital stays. drgs provided incentives for hospitals to diagnose and treat patients expeditiously and effectively. payment for medicare and medicaid patients shifted to this method placed the public insurance plans in a stronger position for payments to hospitals. in many states this has also become standard for patients with private health insurance as well. during the late s, the term managed care was introduced, expanding from hmos of the kaiser permanente type to include both non-profit and for-profit systems. these include independent practice associations (ipas), which operate with physicians in private practice, and preferred provider organizations (ppos), which provide insured care by doctors and other providers associated with the plan to the enrolled members or beneficiaries at negotiated prices. the drg payment system and hmos or managed care systems reduced hospital utilization. while total costs of health care increased in this period, without reduction of hospital utilization the increase would have been considerably higher. in , president clinton tried to introduce a health plan based on federally administered compulsory universal health insurance through the place of employment. a state could opt to form its own health insurance program including through its own department of health. physicians could contract with health insurance plans to provide care on a fixed-fee schedule, or in hmos, whether based on group or individual practice. the clinton health plan failed in congress mainly due to well financed opposition by the insurance industry and the organized medical community. in addition, opposition was also widespread among the majority of the population who already had good insurance benefits under their employment-based health insurance plans or medicare. their interest was in keeping the status quo so that the bill was defeated. following the failure of the clinton national health insurance proposal, managed care experienced tremendous growth. managed care systems have been able to cut costs in health care in ways that the us government could not. in the us as a whole, in addition to the nearly million persons enrolled in hmos, another million persons are enrolled in ppos, with percent of medicaid and percent of medicare beneficiaries in various "managed care plans". the search for cost containment led to the development of a series of important innovations in health care delivery, payment, and information systems. hmos demonstrated that good care provision can be operated efficiently with lower hospital admission rates than care provided on a fee-for-service basis. the managed care systems brought about profound changes in health care organization in the united states. in , president barack obama established the patient protection and affordable care act/health care and education reconciliation act of , widely known as the affordable care act (aca or obamacare) bringing health insurance to millions of previously uninsured americans when it went into effect in (see box . ). the aca requires most companies to cover their workers, and mandates that everyone has coverage or pay a fine. aca also requires insurance companies to accept all newcomers, regardless of any preexisting conditions, and assists people unable to afford insurance. this legislation covers young people under their parents' health insurance plans until the age of , covering . million young americans. it eliminated other limits on coverage, allowing those who had already reached a lifetime limit to be eligible for coverage. the affordable care act introduced discounts as large as percent for pharmaceuticals for seniors. health care reform is currently a contentious issue with the donald trump government planning to repeal the obama health care reforms to be replaced with a plan still under development. us health care spending increased from . percent of gdp in to . percent in , threatening the ultimate insolvency of medicare and cutbacks in medicaid in the near future. lack of universal access and the empowerment it potentially brings encourages an alienation or non-engagement with early health care for the socially disadvantaged sector of the population. this promotes inappropriate reliance on emergency department care and hospitalization in response to under-treated health needs. with large numbers of uninsured persons and many others lacking adequate health insurance, access and utilization of preventive care are below the levels needed to achieve social equity in health in the us. this is especially true for maternal-and child-health and for chronic diseases such as diabetes, hypertension, cancer, and heart disease. infant mortality rates in the united states vary greatly by race and ethnicity. as measured by the infant mortality rate, the rate among non-hispanic black mothers was . times higher than the rate for white non-hispanic mothers. a significantly higher rate of infant mortality exists among puerto rican and american indian populations compared with the national average. cdc reports that maternal mortality rates have increased in the united states between and from . to . per , live births possibly due to changes in reporting and increase in chronic illnesses and influenza during pregnancy particularly in the african american population. in , the department of health and human services (dhhs) released healthy people with two main goals: "increase the quality and years of healthy life" and "eliminate health disparities." these goals focus on specific areas developed by over national membership organizations and state health, mental health, substance abuse, and environmental agencies. many states have adopted use of these targets as their own measures of health status and performance. the us public health service, in cooperation with the national center for health statistics, regularly make available a wide set of data for updating health status and process measures relating to these national health goals. various preventive health initiatives are in place to try to alleviate health disparities, which successfully improved immunization coverage of us infants to meet national health targets, as well as for lead and other efforts directed toward poor population groups. in , a program called racial and ethnic adult disparities in immunization initiative was introduced in order to improve influenza and pneumococcal vaccinations among minorities aged and over. the us department of agriculture's women, infants and children (wic) program enables millions of poor americans to have good nutritional security. the wic program covers pregnant women, breastfeeding women (up to infant's first birthday), non-breastfeeding postpartum women (up to months after the birth of an infant or after pregnancy ends) and infants and children (up to their fifth birthday). wic serves percent of all infants born in the united states. the benefits include: supplemental nutritious foods, nutrition education and counseling at wic clinics, screening, and referrals to other health, welfare and social services such as completion of immunization and special needs counseling. school lunch programs are widespread under a federally assisted meal program operating in over , public and non-profit private schools and residential child care institutions, providing nutritionally balanced, low-cost or free lunches to more than million children each school day in . nutrition support for pregnant women and children in need, alleviates some of the ill effects of poverty in the united states, but lack of health insurance affects these groups severely especially in chronic disease, trauma, and other diseases of poverty. health disparities are a complex problem that goes beyond the issue of uninsured americans. low-income and illegal immigrants face challenges to access medical insurance. new immigrants must wait five years before they are eligible for medicaid. the structure of the medical system plays an important role in an individual's ability to obtain medical care. this includes convenience of making an appointment, office hours, waiting times, and transportation. a lack of health literacy also plays a role in an individual's ability to seek medical attention. individuals not fluent in english experience communication gaps. in , it was estimated that an excess of usd $ billion a year is spent on health care in the united states as a result of low health literacy. in certain areas of the country, medical facilities are scarce. minorities are under-represented in medical professions. black, latino, and native american populations make up approximately six percent of the physician workforce, although these populations represent over percent of the population in the united states. health disparities remain an important social and political issue in the united states. the office of minority health (omh) of the department of health and human services was established in to address issues of health disparities among racial and ethnic minorities. important health disparities exist in america in relation to region of residence, with the southern states having high rates of obesity, stroke, and coronary heart disease mortality, which are thought to be due to customary diets rich in fatty and salty foods. state health departments will need to address these issues in order to reduce gaps in life expectancy due to lifestyle factors which are grounded in tradition and poverty as well as lack of health insurance. one of the main goals of healthy people is to eliminate health disparities. the us has developed extensive information systems of domestic and international importance. the cdc publishes the mmwr (morbidity and mortality weekly report), which sets high standards in disease reporting and policy analysis. the us national center for health statistics (nchs), the health care financing administration (hcfa), the us public health service (usphs), the food and drug administration (usfda), the national institutes of health (nih), and many nongovernmental organizations (ngos) carry out data collection, publication, and health services research activities important for health status monitoring. national nutrition surveillance and other systems of health status monitoring are reported in the professional literature and in publications of the cdc. national monitoring of hospital discharge information facilitates the understanding of patterns of utilization and morbidity. these information systems are vital for epidemiologic surveillance and managing the health care system. us surgeon general reports have an important influence on health systems not only in the united states, but also internationally. the cdc created the national center for public health informatics (ncphi) in to provide leadership and coordination of shared systems and services, to build and support a national network of integrated, standards-based, and interoperable public health information systems. this is meant to strengthen capabilities to monitor, detect, register, confirm, report, and analyze data, as well as provide feedback and alerts on important health events. this will enable partners to communicate evidence that supports decisions that impact health. electronic medical and personal health records are now widely used. these protect patient privacy and confidentiality, and serve legitimate clinical and public health needs. media coverage of health-related topics is extensive, and is important to promote health consciousness in the public. however, the sheer volume of information may make it difficult to discern which information is most relevant, and due to misinformation on internet sites, can also create opposition to public health initiatives such as the refusal to vaccinate children. public levels of health knowledge grow steadily, but vary widely by social class and educational levels. in , the us surgeon general's report healthy people set a series of national health targets for a wide variety of public health issues. the program defined objectives in program areas within the three categories of prevention, protection, and promotion. these goals and objectives were formulated based on research and consultation by experts in different fields who participated in a conference by the us public health service. consensus is based on position papers, studies, and conferences involving the national governmental health agencies, the national academy of science institute of medicine, and professional organizations such as the american academy of pediatrics (aap), the us preventive health services task force, and the american college of obstetrics and gynecology (acog). many private individuals and organizations contribute to this effort, including state and local health agencies, representatives of consumer and provider groups, academic centers, and voluntary health associations. these targets are periodically assessed as performance indicators of the us health system and then updated. progress made during the s included major reductions in death rates for three of the leading causes of death: heart disease, stroke, and unintentional injuries. infant mortality decreased, as did the incidence of vaccine-preventable infectious diseases. the latest iteration, healthy people , identifies national health priorities. it strives to increase public awareness and understanding of the determinants of health, disease, disability, and opportunities for progress. it defines measurable objectives and goals for federal, state, and local authorities in the areas of health promotion, health protection, preventive services, surveillance and data systems, and age-related and special population groups. the final reviews of healthy people showed significant decreases in mortality from coronary heart disease and cancer. healthy people renews this effort to establish national targets which are adopted by state level governments and strongly influence policy in health insurance systems. the us has managed to achieve many of the targets set by the surgeon general's healthy people report. at the same time, the average annual increases in health care expenditures in the united states slowed markedly from the À period with average annual increases of . percent, falling to under percent annually between and . this is partly due to lower general inflation rates (, %), but also cost-containment measures being adopted by government insurance (medicare and medicaid) programs, the health insurance industry, the growth of managed care, and rationalizing the hospital sector by downsizing and promoting lower-cost alternative forms of care. national health insurance was delayed by congressional rejection of the clinton health plan. president barack obama's affordable care act (aca) provided millions of previously uninsured americans health insurance within better regulated private insurance or in state-run medicaid plans, but in is facing "repeal and replace" efforts by the president trump administration and republican congress. a number of possibilities exist to extend health insurance coverage: state health insurance initiatives with federal waivers and cost-sharing; a federal single payer universal coverage plan based on the federal medicare model or a federal-state medicaid model. the us health system is often called a costly and inefficient nonsystem. there are many stakeholders and providers, high costs, and poorer population health results than those achieved in other industrialized countries such as britain, germany, and canada. the health system is diffused with high levels of coverage for diverse insurance plans through employment-based insurance along with publicly financed and administered health insurance (e.g., medicare, medicaid, aca). inequalities are a significant health challenge in the us along with the uninsured, poverty, aging of the population, rising levels of obesity and diabetes. the principle of universal access through public insurance for all is still a highly politicized issue in the united states, although public acceptance seems to be gradually growing. the us has a reputation for good to outstanding quality of medical care, but for those without insurance, services are limited to hospital emergency care only. important ethnic, social, and regional inequities in health status are still present, but not necessarily greater than in countries with universal access health care plans such as the uk nhs. further, there are many parallel programs in the united states that have important positive public health content, such as universal school lunch programs, nutrition support for poor women, infants, and children (the wic program); food stamps for the working poor; fortification of basic foods, free care for the uninsured in emergency departments, medicare for the elderly, medicaid for the poor, and aca coverage for the near-poor. box . shows the challenges of the us health system. despite rapid increases in health care expenditures during the s and s, despite improved health promotion activities and rapidly developing medical technology, the health status of the american population g preventive programs strong tradition; screening for cancer; smoking reduction; food fortification, school lunch programs; nutrition support for poor pregnant women and children (wic); g hospitals obliged to provide emergency care to all regardless of insurance status, citizenship, legal status or ability to pay has improved less rapidly than that in other western countries and universal coverage has not been achieved. us performance measures are lower than many middle-and high-income countries with much lower per capita health expenditures, including measures such as infant mortality rates and life expectancy. infant mortality in the us remains high in comparison to oecd countries and ranks th among all countries in (estimated). even the rate of infant mortality of the white population of the united states was higher than that of countries that spent much less per person and a lesser percentage of gnp per capita on health care. life expectancy at birth in the united states in was below that of countries, just behind costa rica, portugal and slovenia. in , the us life expectancy at birth was . years, well below the oecd average of . years. social inequities in these health status indicators are further evidence of failures of the united states health system to reach its full potential, despite its being the costliest system in the world and its high quality for those with access (commonwealth fund, ) . the advent of the aca (obamacare) introduced in brought health insurance to millions of americans, but is challenged as unaffordable. the us still lacks a universal single payer health plan of canadian or european tradition, but the aca is a huge step forward in america where the working poor are in large measure excluded from access to health care except for emergencies. the struggle for universal access and cost containment are still formidable political and societal challenges for the united states. in , following the russian revolution, the soviet union (ussr) introduced its national health plan for universal coverage within a state-run system of health protection. the soviet model, designed and implemented by nikolai semashko, provided free health care for all as a governmentfinanced and -organized service. it brought free health services to the population, with a system of primary-and secondary-care based on the principles of universal and equitable access to care through district organization of services. it achieved control of epidemic and endemic infectious diseases and expanded services into the most remote areas of the vast under-developed country. this model was also applicable in countries included in the ussr following world war ii until the collapse of the ussr. the model developed in the former soviet union in by semashko brought free health care with governmental management by republic and regional authorities according to national norms set out by the ministry of finance. since the s health care became available for all with mostly underdeveloped basic infrastructure for health care including human resources. the semashko plan provided universal access to preventive and curative care, and control of infectious disease in a uniform plan, with many republics previously having only primitive care available, achieving national standards of services and improved health indicators. since the s, an "epidemiologic transition" was occurring characterized by declining mortality from infectious diseases and rising death rates from non-infectious diseases. life expectancy increased since , still remains far below levels in many medium-income developed countries. the transition in health systems following the collapse of the soviet union in took different paths for the socialist central and eastern european countries (cee) as compared to the core countries of the soviet union, called the commonwealth of independent states (cis). the cee countries moved rapidly to dismantle their soviet, centrally managed sanitary-epidemiological system (sanepid) system with decentralization while retaining universal coverage with central funding, but with local authority participation in some cases. most cee and cis countries have introduced health insurance systems, with more out-of-pocket payments (both formal and informal), and efforts to strengthen primary health care, with family medicine delivered by general practitioners. in most cases central authorities also maintained responsibility for epidemiological surveillance and environmental monitoring with some transferring responsibilities for environmental health in other ministries. the cee and cis countries maintained similar levels of health expenditures as percent of gdp between six and seven percent over the past decade, while the original european union (eu) countries reached an average of percent of gdp. the cis acute care hospital bed capacity ratio declined to six per population in far higher than cee countries (declined to . per ), which were higher than the western countries, although all country groups were declining (see chapter ) . the importance of these differences lies in the fact that total resources allocated for health in the soviet system was relatively low while the allocation allowed hospital care to consume some percent of total expenditures compared with less than percent in western countries. the outcome of this allocation of resources was weakness in development of primary care, prevention and community care in favor of an over-developed hospital bed supply. the russian federation adopted a mandatory health insurance (mhi) plan in to open up additional funding for health care in the face of severe governmental funding constraints. it remains a highly centralized system and is struggling to provide universal access to basic care. despite this, death rates from avoidable causes such as stroke and coronary heart disease have declined in the past decade and life expectancy has risen modestly, but remaining far below western as well as former socialist countries of central and eastern europe. developing national health systems with universal access has been a long process in high-income countries and is an important goal for all countries including medium-and low-income countries to promote improving access to health for the total population. the commonwealth fund published an outstanding international profile of selected health care systems in highincome countries ( ) including: australia, canada, china, denmark, england, france, germany, india, israel, italy, japan, the netherlands, new zealand, norway, singapore, sweden, switzerland, and the united states. global spending on health is expected to increase from us$ . trillion in to $ . (uncertainty interval . À . ) trillion in (in purchasing power parity-adjusted dollars). we expect per-capita health spending to increase annually by . % ( . À . ) in high-income countries, . % ( . À . ) in upper middle-income countries, . % ( . À . ) in lower middle-income countries, and . % ( . À . ) in low-income countries. low-and medium-income countries face major difficulties in developing universal health coverage, especially in terms of financial and professional resources. a study of global health care financing (dielman et al lancet ) reported on health expenditures from countries, including public, donor, and private ("out of pocket") payments between and . high-income countries spent more, and mostly from public sources, increasing expenditures by an estimated three percent per year. medium income countries increased their health spending more than three-four percent per year and low-income countries by two percent. economic development was positively associated with total health spending and a gradual shift away from a reliance on development assistance and out-of-pocket spending towards government spending. in , . percent of all health spending was financed by the government, although in low-income and lower-middleincome countries, percent and percent of spending was out-of-pocket, . percent and three percent respectively was with development assistance. recent growth in development assistance for health has been tepid. between and , it grew annually at . percent, and reached usd $ Á billion in . nonetheless, there is a great deal of variation revolving around these averages. in countries spending less than five percent of gdp on health, included many in asia, the middle east and sub-saharan africa (institute of health metrics and evaluation, ). while there is wide variation in health spending in low-and lowermiddle-income countries and there is overall increased spending in absolute terms, there is still a heavy reliance on out-of-pocket spending and development assistance, which itself is growing very slowly. this indicates that medium-and low-income countries are not providing the financial means to develop universal health access insurance plans. economic growth also does not translate into adequate funding for universal health care without dramatic changes in policy and decreased dependency on donor aid. international agencies-such as who-are promoting the search for ways to provide universal and equitable care, while controlling costs and improving efficiency in low-and middle-income countries. the universal declaration of human rights, article states: "( ) everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. ( ) motherhood and childhood are entitled to special care and assistance. all children, whether born in or out of wedlock, shall enjoy the same social protection." the universal declaration of human rights specific inclusion of access to medical care for all should be seen as a priority in planning universal health insurance (uhi) for promotion of access to health needs for remote rural populations as well as urban poor, and displaced persons. this also applies to conditions of warfare, civil strife, natural disasters as well as incitement to and actual genocide. as said previously, the global consensus of the mdgs ( À ) and the sdgs ( À ) have undertaken to implement key elements of this important declaration. it is easier to be pessimistic than optimistic in the potential for success, but the significant achievements of the mdgs in poverty reduction, educational equity between the genders and in reduction of child and maternal mortality as well as in control of hiv, malaria and tuberculosis are signs of important progress and future possibilities. national governments must take up the financial burdens and management of expanding health systems as well as contributory advances in education, environment and other government sectors toward achieving these goals. bilateral aid and international donors are vital, but they cannot achieve or sustain all this without national commitments and resources. national health systems are essential to provide universal access to health care, but must be developed recognizing that restraint in increasing costs, equity in access and quality, as well as efficiency and effectiveness in use of resources are vital to achieve health targets and equity in population health. in the united states, a study of ethnic differences in utilization of services among medicare beneficiaries who have the same entitlements show significant differences indicating lesser use of preventive services such as mammography and higher rates of lower limb amputation for diabetes indicating poorer management of diabetes. studies in the united kingdom also show sharp differences in mortality rates by region of residence that correlate with socioeconomic gradations. universal access alone does not guarantee equality so that the design of service systems needs to take into account differing needs of groups or regions at higher risk and greater need. universal access by itself is important, but not sufficient to reduce inequalities, which have more complex needs than medical care alone. universal coverage health insurance must be developed with great care to avoid mistakes made in many countries in previous decades of promoting rapid increase in health expenditures to the benefit of the middle class while rural and poor urban populations linger in relatively poor health. a universal health insurance plan without strong incentives for prevention and community health will find itself in a trap of punishing the poor for the benefit of the rich. population health experience of the past century has shown the power of public health, in all its aspects, to raise life expectancy and quality, yet inequalities still plague all health systems. this provides an ethical challenge in planning, resource allocation and political support. beyond financing and resource allocation, there are many "nontariff" barriers to health. even in highly developed national health systems, social class, place of residence, education level, and ethnicity play significant roles in morbidity and mortality rates. addressing important health risk factors other than medical or hospital care is vital. the disease-risk factors of diet, smoking, physical fitness, nutrition status including obesity, and untreated hypertension. such conditions are not necessarily managed even where all residents of a country are insured for health care. social class, ethnic and regional differences in morbidity and mortality exist due to povertyassociated factors, such as insecurity, lack of control over one's life, lack of financial means or knowledge to purchase healthy foods, as well as fear, loneliness and depression. these are issues that are important and must be addressed in public health policy to reduce inequalities in health and the achievement of national health goals and equity. models of financing of universal health insurance include a variety of methods: general taxation; social security by employee-employer payments through payroll deductions; private insurance under contracts between employee and employer; and private out-of-pocket payments. taxation financing can be mainly through progressive income tax, resource taxes, surcharges or "sin taxes" (e.g., on cigarettes, alcohol, gasoline) and excise taxes along with local property and business licensing taxation where local authorities have a management role. funding by general tax revenues at national or state levels or shared between the two levels provides for more local administration while sharing in costs may be the most equitable way of raising funds. many countries use social security systems based on employerÀ employee contributions to pay for health services. the who, the world bank and oecd promote universal health insurance (uhi) for middle-income countries. the advantage will be to reduce the heavy burden of out-of-pocket payments, which are percent of health expenditures in many emerging countries. universal health insurance provides security for individuals and families against catastrophic health events, for regular medical and hospital care, and for ageing populations with increasing health needs. oecd recommends increasing health expenditures, which improves life expectancy, and to allow uhi implementation. even a percent increase in national health spending has been shown to reduce child mortality across many countries. universal health insurance must include promotion of greater efficiency in health care, such as shifting of services from hospital care to outpatient and primary care along with community and home-based care (see chapter ) . the process requires developing new health care provider roles with emphasis on outreach to groups with greater than average need, promoting public health and preventive care such as for underserved rural or urban communities or groups at special risk for disease such as cardiovascular disease (cvd) and diabetes, making use of epidemiologic and sociologic health data and information systems. universal health insurance undoubtedly contributes to improving health indicators such as life expectancy by coverage of the total population, systematizing financing of the health system and providing access to the population. however, without good management of resource allocation, universal health insurance cannot guarantee achievement of important health targets. allocation of resources is a fundamental problematic aspect of universal health insurance. national health policy governing universal health insurance must invest adequately in health promotion and disease prevention in order to reduce excessive allocation and utilization of hospital care. continuous monitoring and evaluation are essential to a health system, but not only for traditional outcome indicators, such as infant, child and maternal mortality rates, and disease-specific mortality rates. these are all valuable indicators of population health, but not sufficient. input, process and outcome indicators are important and necessary to include, such as supply and distribution of resources e.g., primary care, maternity centers, hospital beds; process measures e.g., immunization rates, incidence of vaccine-preventable diseases, growth patterns and anemia rates in infancy and childhood, food fortification, micronutrient supplements to risk group, prenatal delivery and neonatal care. outcome measures include prevalence of disabling conditions morbidity and mortality rates. disability adjusted life years (dalys) and quality adjusted life years (qalys) help change the emphasis from mortality to quality of life measures as part of the evaluation. national health systems require data systems that generate information needed for this continuous process of monitoring. monitoring of hospitalizations, length of stay, health-care facility acquired (nosocomial) infection, readmission rate by diagnosis and many more indicators, compliance with standards of care such as in infection control, surgical and maternal mortality, including infection and error rates, and other qualitative measures are now part of monitoring and payment systems. high-quality academic centers are needed for training epidemiologic, sociologic, and economic analyses professionals as well as health system managers and to carry out the studies and research vital for health progress. health systems are large-scale employers and among the largest economic sectors in their respective countries, with À percent of gdp in middle-and high-income countries and, therefore, a major factor in the total national economy. but the gap between countries is very high. many countries have per capita spending of less than usd $ per year, so that inadequate resources prevent people from receiving quality health care, without unaffordable out of pocket expenditures. in contrast, in many high-income countries annual health expenditures are above usd $ , per capita. donor aid to low-income countries from bilateral or international agencies or other donors rose rapidly from with an estimated $ billion usd to a peak of usd $ billion in , with only a modest change up to . low-income nations, many of which are undergoing important economic development, are under-spending in national allocations to the health sector and remain highly reliant on international aid. a goal of five to six percent of gdp spent on health is widely regarded as a minimum to provide the health care needed in any country. a study published in lancet by the institute for health metrics and evaluation, indicates that only one of low-income countries, and out of of middle-income countries, are expected to meet the target of five percent. low rates of national health expenditures in countries will be a serious limiting factor in improved health and universal access, especially if preventive care is unable to compete for resources as compared to clinical and hospital services. all countries face problems of financing, cost constraint, overcoming structural inefficiencies, and funding incentives for high quality and efficiency in health services. national health systems are necessarily complex, but go well beyond medical and hospital care. the quality of the community infrastructure-sewage, water, roads, communication, urban planning-social support such as pensions and welfare for the disabled, widows, orphans and others in need are essential for population health. attention to the quantity and quality of food (i.e., food and nutritional security), levels of education, and professional organization are all parts of this continuum. national health systems are not only a matter of adequacy and methods of financing and assuring access to services; they must also address health promotion, national health targets, and adapt to the changing needs of the population, the environment, and with a broad intersectoral approach to health of the population and the individual. the structure, content, and quality of a health system plays a vital role in the social and economic development of a society and its quality of life. universal access is increasingly widely accepted as essential to reduce the social inequalities in health. even when income gaps are high. however, vulnerable populations with higher levels of risk than those of the general population are still relatively deprived even under classical universal insurance systems. the key common factors of elevated vulnerability are poverty, isolation by geographic location, physical access by reasons of residency location, ethnicity, education and institutional barriers which reduce access. these inequality factors are the achilles heel of classical universal health insurance and service systems most of which have sought health promotion measures. there can be little doubt that universal access to health insurance or service systems reduces inequalities, but they require imaginative and outreach-oriented approaches to reach those urban and rural poor, people of aboriginal descent, those with an income lower than the poverty threshold, the unemployed, the homeless, and those who have not completed secondary education. societal programs to increase family disposable income for the poor are effective in reducing the health inequities. the two are complementary and equally important in social policy. in the united states more than ten percentages of the population are without any, or have inadequate, health insurance. loss of health coverage with change of place of employment and the rapidly increasing cost of private health insurance generated widespread pressure for a national health program. the business community, too, loses confidence in voluntary health insurance as costs of health insurance mounted rapidly and as a cost of employment in an increasingly harms the competitive international business climate. narrow planning for health systems ignores this message at the risk of missing their targets of improved health indicators, such as those adopted by the united nations-i.e., the millennium development goals and sustainable development goals. the mdgs and sdgs represent a growing movement of globalization of health with economic and political dimensions and greater stress on human rights to health policy. they are particularly relevant to lmics (low-and middle-income countries), but high-income countries have health inequalities that require new approaches based on outreach poverty abatement, and health promotion concepts. mdgs and sdgs presented a challenge to establish common data systems for performance measures to monitor effectiveness of policies and programs. this helps to build capacity for target-oriented health planning in low-and middle-income countries (lmics). a holistic view of health for all must take into account the many reasons for health disparities and disadvantage to the poor in health status. insurance to pay for doctors, hospitals, laboratories and imaging centers is necessary, but not sufficient, to raise population health standards for all. the "nontariff barriers"-i.e., issues beyond payment for services which may be addressed with incentives in payment systems, not only to reduce hospital length-of-stay, but to reduce health-care acquired infections, reaching out to chronically ill people with health promotion measures such as nutritional support, pneumonia and influenza immunization, hypertension control, cancer screening, and many other features of public health promotion. since the s, when bismarck introduced national health insurance in germany as part of social security with funding though sick funds, many countries have grappled in unique ways with developing health care systems. national health insurance systems developed through social security and social welfare systems, by national health insurance, or options to provide access to health services. in canada national health insurance provides universal coverage through national support for provincial health plans, paid for by general taxation, with national criteria. in the united states, president lyndon johnson established social security-based health insurance for the elderly and the poor through amendments to the social security act of , and president barack obama extended health insurance through the affordable care act of . the uk national health service-with the northern ireland, scottish and welsh nhs run semi-independently-was established in , providing a state-run system of medical, hospital, preventive, and community health care. though not discussed here, nordic and other european health systems provide universal coverage with involvement from all three levels of government, but over percent of expenditures are funded through public sources. in denmark, norway and sweden county councils are central to funding and management; in finland, the municipalities provide most of the health care. the former socialist countries have gone through painful periods of transition. many of these countries have developed free-market systems with dynamic growth in national economies along with health system reform. health systems in transition have adapted with great gains in longevity and reduced mortality from preventable diseases in many former socialist countries in central and eastern europe. others have had difficulties addressing the "missed epidemiologic transition" from infectious disease to control of noncommunicable disease but have begun to make progress in the st century. globally, public and private donor partnerships have emerged to help the poorest countries cope with overwhelming health problems of raising immunization coverage levels, reducing child and maternal mortality, managing hiv, tuberculosis, malaria, diarrheal and respiratory diseases and vaccinepreventable diseases in keeping with the mdgs based on a consensus of all member nations of the un. the objectives and specific targets included: reducing poverty, improving equal access of boys and girls to primary education, reducing child and maternal mortality, managing significant diseases such as hiv, tuberculosis, and malaria, along with improving the environment. reaching the targets for achieving these goals depends on developing infrastructures of health systems that provide access for all and distribution to meet geographic and social inequities in health. each country needs to develop its own system, but can learn from the experience of others. the purpose of this case study is to highlight the unique and common features, including positive and negative lessons learned from national health systems. observing and learning can help in defining needs for countries lacking but aspiring to achieve universal health systems, including positive and negative challenges. universal access is an important means of assuring that the economic barrier is removed for the total population, leading to increased access to medical and hospital services for those previously lacking the means to reach these services. universal access systems have been achieved in most industrialized countries. however, the us has not achieved this goal even with, by far, the highest health expenditures of oecd countries. this is due mainly to political gridlock despite success with its single payer system for medicare for the elderly. for low-income countries, the rates of health expenditures at present and forecast for the coming decades will be insufficient to achieve universal access systems. there must be a fundamental political change in national policies with health as a higher priority for funding and leadership. universal healthcare access is still a work in progress. the goal of universal access is a worthy one: to make health care accessible to all. the advent of universal access, however, is not assured given low levels of funding in many countries most in need of improved access but strengthening health systems: the role and promise of policy and systems research. geneva: global forum for health research alliance for health systems policy and research. world health organization. what is health policy and systems research (hpsr)? . geneva: world health organization achieving a high-performance health care system with universal access: what the united states can learn from other countries health spending in the united states and the rest of the industrialized world the publicÀprivate pendulum-patient choice and equity in sweden uk health dividesÀwhere you live can kill you disease and disadvantage in the united states and in england lessons from the east-china's rapidly evolving health care system the affordable care act at five years gatekeeping in health care the organization of personal health services. milbank quart noncommunicable diseases: stepping up the fight: how the russian federation is collaborating with other commonwealth of independent states' countries comparing health systems in four countries: lessons for the united states germany: health system review germany and health : statutory health insurance in germany: a health system shaped by years of solidarity, self-governance, and competition how canada compares: results from the commonwealth fund international health policy survey of primary care physicians healthy people : topic areas at a glance. national center for health statistics, last reviewed national health expenditure fact sheet, last modified health and health care in israel: an introduction. lancet. . special series international health 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geneva: world health organization health systems: improving performance european health report : charting the way to well-being. copenhagen: world health organization research for universal health coverage world health organization. european health for all database (hfadb) world health organization. health systems: health system financing universal health coverage: sustainable development goal , health relying heavily on donors and out-of-pocket payments. the devil is in the details. . universal health insurance (uhi) or national health service systems are essential for advancing population health and should be give high priority in policy and funding by national governments and international aid agencies in middle-and low-income countries in the coming decades. . universal health insurance or service systems cannot be expected to succeed without continuing development of public health and health promotion as equal needs for population health and to achieve sdgs. . all countries seeking health development will need to raise public support for financing health systems by raising health expenditures to more than five -six percent of gdp. . all countries addressing these issues should endeavor to expand training to include bachelor and master degree training in public health and health systems management in order to raise the professional leadership and management levels to lead in the complexities of health systems in the challenges ahead. health promotion to hospice care on par with acute and rehabilitation care hospitals as essential, but managed so as to avoid unnecessary economic domination of the health system and potentially damaging health-care infections and trauma. . reaching out to populations-at-risk and in need of preventive care and health promotion by multi-professional and paraprofessional teamse.g., community health workers, is vital to address chronic care needs and prevent their complications, for remote villages or urban poverty areas, or to groups of people with chronic disease conditions. . health information systems including development and implementation of epidemiology and information technology for monitoring of disease and quality of care require emphasis. . immunization and nutritional support for prevention of infectious diseases, chronic diseases and micronutrient deficiency conditions are crucial for population health and should be given high priority in health system development. . health policy management is vital to achieving universal health coverage to advance population health, but it must be seen as part of health in all strategies and the sdgs to be effective within financial limitations and cost restraint. . health promotion must be developed in all its aspects to raise population and professional awareness with educational and legal means to reduce risk factors in population health. health systems to promote efficient use of resources and achievement of specified health targets? . what methods may be incorporated into national health systems to promote quality of care? . how can developing countries achieve universal health care, and at the same time work toward national health targets such as upgrading maternal and child heath, control of infectious diseases and preventing chronic diseases? . how can low-income countries address the low public expenditure on health to reduce dependence on global financial aid for sustainable development goals (sdgs)? key: cord- -yrc qnmr authors: akbulut, nurcan; limaro, naomi; wandschneider, lisa; dhonkal, rhanjeet; davidovitch, nadav; middleton, john; razum, oliver title: aspher statement on racism and health: racism and discrimination obstruct public health’s pursuit of health equity date: - - journal: int j public health doi: . /s - - -y sha: doc_id: cord_uid: yrc qnmr nan the covid- pandemic has unmasked structural racial inequalities. association of schools of public health in the european region (aspher) member schools need to act against racism now. the covid- public health crisis has elicited strong public health system responses. but the pandemic has also uncovered profound and neglected structural inequalities and injustices in our societies. these structural inequalities developed through enduring discrimination against ethnic, cultural and other minority groups. they became apparent in several ways over the last months. • people of asian descent experienced discrimination in public spaces in reaction to the pandemic presumably having originated in china (devakumar et al. a ). • ethnic/racial minority groups in europe are more adversely affected by the covid- pandemic compared to most white people. in the uk, black people are four times more likely to die from covid- than white people, even after controlling for socio-economic disadvantage (platt and warwick ) . • ethnic/racial minority groups in europe often live in crowded conditions, especially so when they are refugees. under such circumstances, physical distancing is a privilege that they cannot afford (bozorgmehr et al. ). • ethnic/racial minority groups in europe often live in poor social conditions with precarious forms of employment, so they suffer most from the adverse socio-economic consequences of the pandemic. at the same time, they lack equal access to health care as well as social protection, putting them at greater risk of adverse health outcomes. • ethnic/racial minority groups in europe are also often in occupations which have key functions in the pandemic. examples are health and social care, transport, delivery services, food supply and security roles. workers in these fields have been particularly vulnerable to infection (devakumar et al. a ). in summary, the pandemic has not only caused a global public health crisis; it has also increased and accentuated longstanding structural social inequalities and ethnic/racial discrimination (devakumar et al. b) . the amalgamation of different forms of inequalities resulting from racism and socio-economic disadvantages signals an urgent need to protect the health of vulnerable groups. on the one hand, social inequalities which the pandemic reinforces need to be tackled; on the other hand, inappropriate government policy responses to it must be addressed. a striking current instance of this fact is provided in the failure of the european union and its member states to evacuate migrants and refugees from the camps on greek islands to enable living circumstances that allow physical distancing and provide safe spaces (veizis ) . apart from the uk rapid review, there is as yet little work addressing the differential ethnic/racial impact of the pandemic or of social countermeasures taken, of diminished health and social care and of economic disruption. aspher, as europe's representative organization for schools of public health, accordingly has issued its first statement on covid- impact on health inequalities and vulnerable populations on june (aspher ). in addition, aspher will pursue health equity by fighting systemic racism and discrimination. . we will continue to call upon all public health organizations and governments in all countries to strengthen the protection of the health of vulnerable groups. we also call for urgent and decisive action to minimize the social impact of the covid- pandemic on socially and economically marginalized minorities. . racism has a considerable impact on health inequalities. we therefore call on public health scientists to routinely include racism as a fundamental social determinant of health in all research and to strengthen cross-disciplinary collaboration on issues related to racism and health. . we need to rigorously name and scrutinize such systemic disadvantages for what they are, i.e. structural racism (hardeman et al. ). it is a task for society to put an end to systemic racism and structural inequalities through civic engagement, critical awareness, education, equal opportunities in life, political integrity and scientific evidence. in addition, we must hold politicians accountable for their actions, including their handling of information and media. . we advocate for communities and governments to embrace comprehensive public health strategies for addressing all causes of violence in our cities and places. preventive models addressing communities as a whole have to be implemented to address violence and inequalities. these must include significant partnership working and retraining of all statutory workers including those with regulatory powers and workforces, including police, prisons and places of detention. . aspher member schools of public health should be role models for eliminating all forms of racism, discrimination, inequality and disadvantage. . we reassert our commitment to health as a fundamental human right, to equality and fairness, to respect for all people worldwide, to solidarity with oppressed people and to protecting and improving the health of all the people we serve. member schools should review systematically their curricula and teaching with respect to racism, discrimination and inequalities in health and in public health interventions to reduce inequalities and improve health more fairly. . we also call on schools of public health to critically address their own policies with regard to racism and discrimination-as employers, and in their recruitment of staff and students; as landowners and procurers of goods and services, and in their policies towards acceptance of grants and donations. . we call on all our schools of public health to work within their academic institutions to audit, review and develop policies and programmes to address and eliminate racism. racism and discrimination are public health issues, globally and in europe. they are contributing factors to the covid- crisis. as public health researchers and practitioners, we must be aware of this. we need to take the necessary actions to address racism and discrimination in order to attain health equity. acknowledgements open access funding provided by projekt deal. conflict of interest the authors declare that they have no conflict of interest. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creativecommons. org/licenses/by/ . /. covid- -how and why is the pandemic exacerbating and amplifying health inequalities and vulnerabilities in europe? aspher sars-cov- in aufnahmeeinrichtungen und gemeinschaftsunterkünften für geflüchtete: epidemiologische und normativ-rechtliche aspekte abubakar i ( a) racism and discrimination in covid- responses racism, the public health crisis we can no longer ignore naming institutionalized racism in the public health literature: a systematic literature review are some ethnic groups more vulnerable to covid- than others? the institute for fiscal studies leave no one behind'' and access to protection in the greek islands in the covid- era key: cord- - p sjja authors: limcaoco, r. s. g.; mateos, e. m.; fernandez, j. m.; roncero, c. title: anxiety, worry and perceived stress in the world due to the covid- pandemic, march . preliminary results. date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: p sjja introduction: since the beginning of the outbreak in china, ending , the novel coronavirus (covid- ) has spread subsequently to the rest of the world causing an on-going pandemic. the world health organisation (who) declared covid- : a public health emergency of international concern. having into consideration the lockdown and quarantine situation, we decided to do evaluate the current emotional state on the general population with a web-based survey in english and in spanish, which was considered a useful and fast method that could help us determine how people perceived stress and worry due to the covid- . methods: the survey included a items, gathering information in sections: sociodemographic data, the perceived stress scale (pss- ) by cohen and additional queries that assessed the current worry and change of behaviours due to this pandemic. results: the survey received respondents from countries, from march to rd, . the mean age of the respondents was . ( . ) years old, and more than two thirds were women. . % were health personnel.the mean of the pss- score was . ( . ). significantly higher scores were observed among women, youth, students, and among those who expressed concern and those who perceived increased susceptibility to the covid- . in contrast, no significant differences were observed between the health professionals and the general population. a good correlation was observed between mean relative volume (rsv) of the las days and the number of cases reported (rho = . , p < . ) and deaths (rho = . , p < . ). discussion: with these results we describe an increase of affective symptoms due to the covid- . this pandemic is raising the anxiety levels. the findings of our study show the affective and cognitive alterations people are going through. this survey is the first attempt to measure the psychological consequences this pandemic is having, in order to be able to later be able to provide the support to confront this global issue, addressing the mental health care that will be needed. towards the end of , the who china country office was informed of cases of pneumonia with an unknown aetiology detected in wuhan city, hubei province of china. further on, after trying to point out the cause of the outbreak, chinese authorities identified a new type of coronavirus on january , called sars-cov- . on january , , china shared the genetic sequence of the novel virus. since the beginning of the outbreak, what is now known as the novel coronavirus has spread subsequently to the rest of the world causing this particular type of respiratory disease to be a pandemic. covid- can cause anything from mild respiratory problems to pneumonia or death. being men and older people the ones who mostly suffer the severity of this infectious desease. as the on-going pandemic continues to develop, world health organisation (who) declared covid- "a public health emergency of international concern." approximately % of the global covid- cases are currently outside china. at the time the survey was sent (march , ) the global situation registered by the who was: confirmed cases reported , . deaths , (most of them in china and europe-italy and spain mostly). countries and territories with positive cases: . there is a very high rate of reported cases in health professionals. the authors of this article, anticipated that the outbreak of covid- would be stressful for people. taylor et al. , described the high levels of reliance on the support of others to get through tough times, for example, the vulnerability that may be felt by this potential global health threat which is requiring the use of physical control measures, such as social distancing, home quarantine, and school and work closures, all resulting in disruption to social support networks at a time when they may be needed most. brooks et al. , informs that the psychological impact of quarantine is wide-ranging, substantial, and can be long lasting. this change of circumstances and raise of stressors has to make psychiatrists be attentive to possible relapses in patients with mental health problems. taking into consideration the lockdown and quarantine situation, the researchers decided to do evaluate the current state on the general population with a web-based survey that was considered at this moment a useful and fast method that can help determine how people perceived stress and worry due to the covid- . feizi et al. , points out that psychological stresses are also associated with huge increase of mortality in general population, if the quarantine experience is negative, it suggests there can be longterm consequences that affect not just the people quarantined but also the healthcare system as referred to the brooks et al. , study. in order to determine the current and future support people will need to confront this situation. this study aims to observe various points. first, it aims to find out how this pandemic is progressing and how it's producing changes in the affective state of the general population. next, it is expected, that the higher risk groups should score higher in the stress scale, such as older people and health professionals due to the overwhelming situation they are living in hospitals around the world. this survey is the first attempt to measure the psychological consequences this pandemic is having. the results of the study will help determine the mental health care that might be needed. counting that the stress perception founds on cultural and social aspects that can vary from one country to another. on march , we sent a web-based survey with an english or spanish version. both versions were chosen for being the native language in many countries, as well as a good option for those countries who don't natively speak this languages. this study was endorsed by the member in charge of the research ethics committee, of the university of salamanca health care complex. the survey was sent to mainly madrid and manila, and other cities in the world. at that time both cities had already a law enforced lockdown by their governments. the recruiting of the rest of participants was on forums and social networks. those who received the survey and were interested in participating answered the questionnaire freely, knowing that the survey's participation was voluntary and all data is anonymous. the questionnaire had items, that gathered information in sections: . sociodemographic data, including age, gender, nationality, and employment status, as well as the current city they were at at the time of answering the questionnaire and a dichotomous question to specify if they were a health professional or not. supplementing this, they answered the perceived stress scale (pss- ; cohen et al., ) with items, which was chosen for it being a widely used psychological instrument that measures the degree to how circumstances in one's life are detected as stressful. designed to determine how unpredictable, uncontrollable, and overloaded respondents find their lives, which we found ideal for this current situation. baik et al. , show in their study the scores on the pss- were significantly correlated in the expected directions with scores compared in these scales: generalized anxiety disorder- (gad- ) and patient health questionnaire- (phq- ), in both english and spanish language preference groups. in addition, based on the study of the influenza a/h n pandemic of liao et al. , they answered a question per item to estimate (all related to covid- ): the anticipated worry (a prospective measure), experienced worry (a retrospective measure), current worry (a current measure), perceived absolute susceptibility (a prospective measure), perceived relative susceptibility (a prospective measure) and two other questions related to the altered/or not behaviour due to the covid- related to the cdc recommendations: avoiding crowded places and hand cleaning. furthermore, some epidemiological data was obtained from different sources (countries departments of health, newspaper) to explore the possible association of them with the pss- score: days since the first case reported, number of cases and death reported the day before in the country. furthermore, in order to assess the social impact of the disease and its possible correlation with the perceived stress, mean relative volume (rsv) of the and days of each country was obtained from google trends, using the terms "coronavirus" and "covid". dichotomic variables were analysed using chi-square test, u mann-whitney (or kruskal wallis when required) was used to assess the differences between non-parametric variables. spearman's rho was used to measure the correlation between viables. finally, multiple linear regression with backward elimination was conducted to identify independent factors that determine the pss- . statistical analysis was performed using spss package v . . the survey received respondents from countries(figure ), from the th to the st of april, . the majority of participants were from the philippines ( %) and spain ( %) and colombia ( %). in almost all the countries that responded, covid- cases all rights reserved. no reuse allowed without permission. the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which was not peer-reviewed) is . https://doi.org/ . / . . . doi: medrxiv preprint had already been declared before answering the survey (median cases, - ) and the majority of the responses came from countries with reported deaths ( %). the mean age of the respondents was . ( . ) years old, and more than two thirds were women. . % of the respondents were part-time or full-time workers and . % were health personnel ( table ). the mean of the pss- score was . ( . ). significantly higher scores were observed among women, youth, students, and among those who expressed concern about becoming infected with covid- and those who perceived increased susceptibility to the coronavirus (table ). in contrast, no significant differences were observed between the health professionals and the general population, or between those from quarantined countries and those who did not have quarantine in their country at that moment. avoiding crowded places was significantly more frequent among those with the anticipated worry ( . . % vs . %, p< . ), experienced worry ( . % vs . %, p< . ) and current worry ( . % vs . %, p= . ), showing no significant association with susceptibility questions. hand hygiene was significantly more frequent among those with: anticipated worry ( . % vs . %, p< . ), experienced worry ( . % vs . %, p= . ), current worry ( . % vs . %, p< . ) and perceived absolute susceptibility ( . % vs . %, p= . ). none of those behaviours were statistically associated with higher pss- scores. in the linear regression, the items that perform as variable predictors of the pss- were: constant (b , , p< . ), age (b - . , p< . ), female (b . , p= . ) and the sum of responses about worry (b . , p< . ). those variables explained % of the variance (r = . ). an exploratory analysis was performed to assess the possible relationship of the pss- score with the epidemiological impact in the country and public interest in the disease. a weak correlation was observed between the mean rsv of the last days and the number of cases reported (rho = . , p < . ) and deaths (rho = . , p < . ), but none of them showed a significant correlation with the pss- score. all rights reserved. no reuse allowed without permission. the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which was not peer-reviewed) is . https://doi.org/ . / . . . doi: medrxiv preprint these results describe heightened affectivity symptoms due to the covid- . this pandemic is raising the anxiety levels. overall the sample showed a pss- score higher than that reported in the general population (< according to cohen et al. ) and close to the values reported by chua et al. , during the sars outbreak in , which placed it at . . furthermore, in our cohort those who reported concern or susceptibility to covid- were those with higher scores. although the very nature of natural and health disasters is one synonymous with unpredictability, the results of the study show the affective and cognitive alterations people are going through. mackay et al. , described mood adjective checklists as a popular method of gathering data about an individual's phenomenological perception of the behavioural and cognitive components of his reaction to different situations. it could seem contradictory to find that older respondents showed lower levels of anxiety and worry even though this age group is reported as a high risk group. pneumonia causes a more severe condition and even higher mortality among the elderly, as studied in yang et al. we find a negative correlation between age and the score given on the scale. a statistically significant difference is observed between the median score between those over years of age and those under that age. remor e , also shows that the stress scores had a tendency to decrease with age using the pss, suggesting that perceptions of stress tend to decline as age increases, that result must be interpreted with care, as the correlation was very low. in this study, the findings are similar, older people present lower anxiety levels, even though they are the population with higher risk of presenting worse progress in this disease. carstensen et al. , offered reasons for this decline of stress with age, from the selectivity of positive aspects to reduced physical reactivity due to physical and health limitations. frazier et al. , emphasises three key components to explain the changes in integration for social decisions in ageing: theory of mind, emotion regulation, and memory for past experience. the reports from china, italy and spain at present address a high rate of infections in the health professionals. they are the ones who attend to all cases and are high risk group due to the continuous exposure to patients with covid- . although, these findings reflect that the heath personnel get the same stress levels/ pss- score, than the general population, just as described by , describes that health professionals at the moment of the outbreak, do not present higher levels of perceived stress. however they maintain high stress levels for a longer time turning it into chronic stress. a possible explanation to this, is that this professionals are more accustomed to managing higher stress levels because of the nature of their jobs. they are used to encountering critical health situations. furthermore, the survey was carried out at the beginning of the infectious outbreak in many countries, the distress in this personnel was just beginning avoiding crowded places due to covid the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which was not peer-reviewed) is . and could be minimised at that moment. to examine whether the stress level grows in time, alongside the progression of the pandemic would be interesting. many countries have already declared this as a health emergency, taking measures in order to minimise transmissibility, morbidity and mortality; minimising the burden on health care systems. the results of women presenting higher scores of anxiety, was already described by the initial author cohen et al. , and remor e , regarding pss and pss- , women received significantly higher perceived stress scores than men. the reasons for this finding may be related to sex differences in coping with stress. the findings in this paper point out higher levels of anxiety and worry in women. numerous studies, uhlenhuth et al. , show how women report higher intensity of the symptoms than men, and kendler et al. , displays gender and sensitivity to the depressogenic effect of stressful life events, where women reported higher stress rates. the study of dalgard et al. , explains why with a more affiliative style, and a stronger involvement in household and family matters, women are more exposed to problems in the social network. based on this, women are more likely than men to report events in the social network, as it shows the contribution in each gender to this survey. the main finding in the liao et al. , study is that affective measures of risk perception generally had stronger associations with reported modification of health protective behaviours. the behaviours examined in this survey to reduce the exposure to the infection were: the higher concern in avoiding crowded places and performing hand sanitising conducts almost all the time. no significant correlation was found between the reported cases and deaths of covid in the country at the time of the survey and the pss- score. additionally, results did not identify significant differences in stress levels between countries that are currently in quarantine and those that are not, although this finding is limited as the sample of non-quarantined countries is small. as previously described in other infectious outbreaks, bragazzi et al. , at country level there was a correlation between digital interest toward coronavirus and epidemiological data (total cases and death reported), which was not found in this study with the pss- . nevertheless, further studies will be required to explore the possible association. one of the future objectives is to assist health workers and the general public in managing emotional stress and related personal, professional and family issues during the covid- pandemic. while there is currently no recommended treatment, vaccine, or antiviral medication for covid- , pharmaceutical companies are racing for solutions. our response to mitigate the affective and cognitive consequences on the quarantine can be based on the brooks et al. , recommendations: giving people as much information as possible, providing adequate supplies, reducing the boredom and improving communication. the results of this study should be interpreted within the context of study limitations. methodological issues limit the validity of the research results. in addition the target population is not specific, our study comprised responses from countries, the response from individual countries was not uniform, three countries were mostly represented as well as the demographic bias in the sample, the particular greater proportion of women, which is related as mentioned before with the greater interest for participation in studies of this nature. furthermore, it is important to point out that future studies should also address the different demographics of the health-care system in each country. although the items of this tests based on self-observation also bear a certain degree of ambiguity, for example, by using the term "often," that can be interpreted in various ways, projective techniques, in general, are providing a much wider freedom of response and consecutively provoking a much wider response variety in nature and number going together with a complex procedure of scoring. therefore, they are much more vulnerable by interpreter´s scope of accuracy. based on this description, the researcher propose a follow up and extension of this study to be able to reach more countries and know the mental health impact this pandemic is having. the changes that are assessed can lead to affective and cognitive problems, which should be able to be assisted by health professionals. creating health interventions and preparing to aid mental health issues due to this pandemic is the main objective. reliability and validity 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and sensitivity to their depressogenic effects anxiety, worry and cognitive risk estimate in relation to protective behaviors during the influenza a/h n pandemic in hong kong: ten cross-sectional surveys an inventory for the measurement of selfreported stress and arousal immediate and sustained psychological impact of an emerging infectious disease outbreak on health care workers associations between risk perceptions and worry about common diseases: a between-and within psychosocial stress and strategies for managing adversity: measuring population resilience in new south wales, australia. popul health metr symptom intensity and life events geneva: world health organization clinical course and outcomes of critically ill patients with sars-cov- pneumonia in wuhan, china: a single-centered, retrospective, observational study the authors declare that they have no conflict of interests.biliography: key: cord- - i qws h authors: zhao, y.; cui, s.; yang, j.; wang, w.; guo, a.; liu, y.; liang, w. title: basic public health services delivered in an urban community: a qualitative study date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: i qws h objectives: to understand the advancements in and barriers to the implementation of measures to improve basic public health services in an urban chinese community. study design: a qualitative study based on semi-structured interviews. interviews were audio-taped, transcribed and analysed using thematic content analysis. methods: in-depth interviews were undertaken with the directors of the management centres for community health services in of the districts in beijing from december to february . content analysis of the data was completed in may . results: fifteen types of free basic public health services had been delivered in beijing. some were supplied at a low level. an average of £ . per person per year was provided for inhabitants since , but demand for funding far exceeded monies available. teams consisting of general practitioners, community nurses and public health specialists delivered these services. the number of practitioners and their low levels of skill were insufficient to provide adequate services for community residents. respondents gave recommendations of how to resolve the above problems. conclusions: in order to improve the delivery of basic public health services, it is necessary for beijing municipal government to supply clear and detailed protocols, increase funding and increase the number of skilled practitioners in the community health services. supplying free basic public health services (individual-based clinical preventive services and population-based public health services) in community settings is of great significance in improving quality of life and promoting social harmony. since , the chinese government has promulgated a series of documents for developing basic public health services. e these reports mandated that basic public health services would be funded at all levels of governments and be delivered by the nationwide community health services (chs) organizations. on april , the chinese government released a policy statement which enhanced the reforms of the medical and health systems, and which re-emphasized that governmental bodies will offer equitable access to basic public health services for both urban and rural residents. as the centre of politics, economy and culture of china, beijing municipal government attaches extreme importance to and promotes advances in the development of basic public health services delivered in the community. over the past two decades, china has been undergoing a process of economic reform and has been relatively successful. the healthcare system, which had been reformed to suit the market economy, faced multiple challenges: limited financial support from governments; high rates of catastrophic out-of-pocket spending and impoverishment through health expenses; inequalities in health and healthcare utilization; and limited financial protection even among those with insurance (a small minority of the population). due to the above challenges, the old 'three-tiered' hospital system, which involved local neighbourhood hospitals, district-wide secondary hospitals and city-wide tertiary hospitals, was forced to rely on the sales of new drugs and technologies to boost income, which resulted in expensive and inefficient care and strained patientedoctor relationships. the old public health system was the responsibility of dozens of disparate institutes, centres, agencies, bureaus and departments, which resulted in overlapping and sometimes conflicting mission statements and agency mandates. with an increase in life expectancy, increased burden due to chronic diseases, and the challenges of emerging infectious diseases (e.g. severe acute respiratory syndrome in ), the chinese government re-examined the public health infrastructure and saw the need for a new public health system to address the many health issues associated with these changes. to minimize overlapping of functions and to increase efficiency, the chinese government consolidated existing institutions into a new agency: the centres for disease control and prevention (cdc). the goal of the cdc is to provide a central public health organization with responsibility for both community and individual health needs. the development of the cdc strengthened the government's role in public health. as public health and primary care share the common goal of improving the overall health of specific populations, it was decided to integrate the two systems by strengthening public health functions in primary healthcare settings. this approach could improve local public health surveillance and reinforce disease prevention and health promotion. in order to resolve the problems of the increasing burden of healthcare expenses and limited access to health services, the chinese government initiated its chs programme in . the 'threetiered' hospital system was replaced by the current 'twotiered' chs centre system. the new system consists of ambulatory care in chs centres and inpatient care in referral hospitals. the main roles of the chs centres are to provide high-quality, affordable, accessible primary health care and public health services to community residents. the scope of services of the chs centres is described symbolically by the chinese government as 'one body, six aspects'. the body is the chs centre. the six aspects consist of basic clinical services, prevention, health education, women and children's care, elderly care, immunizations and physical rehabilitation. the centres integrate western and traditional chinese medicine. in the population-based public health services, there is collaboration between the community health centres and the local cdc. local governments are the main sources of funding for the local cdc and chs centres. the core providers in the chs centres are general practitioners (family doctors), , public health specialists and community nurses. these practitioners are responsible for the provision of basic clinical services and for maintaining the wellness of the residents, of all ages, in their communities. in china, a general practitioner is a medical practitioner with recognized general training, experience and skills, who provides and co-ordinates comprehensive medical care for individuals, families and communities. , two models are currently being used to train general practitioners in china. the first model is a -year general practice postgraduate residency training programme. the second model of education involves retraining the majority of the less-educated doctors currently working in local community health centres, and transforming them into general practitioners. completion certificates are awarded by different organizations, including the central ministry of health, provincial ministries of health and city-level health bureaus. , general practitioners typically work in the clinics of chs organizations. when delivering population-based public health services, general practitioners often work in teams with public health specialists, community nurses and other providers. , in , in order to implement the chs more effectively, beijing management centre for community health services (mcchs) was established. it is affiliated administratively with beijing municipal health bureau. similarly, a district office of the mcchs is attached to each of the city's district health bureaus. the main responsibilities of beijing mcchs include writing regulations, establishing assessment standards, and organizing practices for the chs while, at the same time, supervising the work of the district mcchss. the district mcchss are responsible for planning, managing and assessing the work performed by all chs organizations in their respective districts. each director of a district mcchs must be familiar with the activities of the chs in his/her district. fifteen types of free basic public health services have been delivered by the chs in beijing since (appendix ). to date, no research has investigated the implementation of these services in beijing. due to an interest in understanding the status of and barriers to basic public health services in the beijing communities, the authors chose to design a study that would investigate the conceptual frameworks of these services. to that end, all mcchs district directors were approached in order to ascertain their opinions of the quality of the delivery of basic public health services by providers in the chs. sampling consisted of all directors from the mcchs distributed in the districts in beijing. after obtaining their numbers from the telephone book, initial contact was made with them. one director was away on business, one was too busy and declined to be interviewed, and one was unable to be reached, despite multiple calls. semi-structured, in-depth interviews were conducted with the remaining mcchs district directors who were familiar with the work in the chs. interviews were usually carried out in the respondent's work offices. all participants were informed about the purpose of the study and were made aware that they could stop the interview at any point without giving a reason. written informed consent and an agreement for the use of anonymised quotes from the interviews were obtained from all participants. semi-structured, face-to-face, tape-recorded, qualitative interviews, lasting e mins, were conducted by trained professional interviewers from december to february . interviewers took extensive notes, in addition to tape recording and transcribing the interviews. the transcripts were reviewed by the research team. analysis and interpretation were reached by consensus, using an iterative process in the research team meetings. the research team was a multidisciplinary group including two community-based medical researchers with qualitative and social research experience, one health administrator from a health bureau familiar with health policy, one family doctor familiar with the chs, two epidemiologists and one masters degree candidate with a family medicine degree. the variety of perspectives of the team ensured a depth of understanding critical to the design of the study and the validity of the results. an interview guide was developed on the basis of references and relevant government documents. the interview questions were open-ended and covered issues about basic public health services, the content of specific services being delivered, funding, types of providers, and general insights of the respondents. qualitative content analysis , was used to analyse the data between march and may . the data consisted of rich text files containing transcripts of the tape-recorded interviews. the team members read all the material through several times to obtain a sense of the whole, and then independently coded transcripts to identify themes by condensing and summarizing the contents. coding differences were resolved after thorough discussion in order to ensure that all perspectives on the themes were represented in the written results. the themes that emerged for the purposes of this report included the content of basic public health services, funding support, providers and recommendations. all of the interviews were included in the analysis; there were no disconfirming cases. the findings relate to three main themes: the content of basic public health services, funding support for basic public health services, and the providers who deliver basic public health services. fifteen types of basic public health services, including specific services (appendix ), were delivered at different levels in the various districts. among these services, most of the directors considered the establishment of health records, chronic disease management, childhood immunizations and care, maternal care, elderly care, disability and rehabilitation services, and health education to be supplied at high levels. however, the provision of mental health, ophthalmologic, oral health, pest control and endemic disease services were low and sporadic in some communities due to the low level of staff competency for these tasks. in community health information management, community needs assessments were one of the important jobs in the community. the directors agreed that it was often necessary for community needs assessments to be undertaken with the assistance of a special research group due to practitioners' limited research skills in this area. the rates of creation of paper health records for all inhabitants were estimated to be high. at present, the governments have attached importance to the development of electronic health records, and the transformation from paper to electronic records is a slow, stepwise process in the communities: "paper health records have been established for % of people in our district, and we plan to complete this work for all our residents by ." "the municipal government required chs organizations to establish paper health records for all residents in beijing. a centre provides services to about , e , residents according to the size of a region. in fact, due to health workforce shortages and a small number of revisiting patients, only % of established paper records can be followed up and used continuously." "how to continuously and dynamically use these health records, especially those of healthy people, is a 'gordian knot'. a feasible method to resolve this problem may be by using an electronic health record information systems to reduce the time spent on paperwork. the first thing that the governments need to do is to establish the standards of electronic record systems and to make experiments in some districts." regarding the management of communicable diseases, most of the chs organizations' roles are limited to assisting the local cdcs with the completion of tasks such as finding, reporting and follow-up of cases: "however, for responses to emergent public health hazards, chs organizations are playing more and more important roles." the management of chronic, non-communicable diseases is an important job for chs organizations because of the high incidence and deleterious effects of these illnesses. providing optimal health care for persons with chronic conditions is a major concern in the community. beijing municipal health bureau has established a set of guidelines for the management of chronic diseases in community p u b l i c h e a l t h ( ) e settings e including hypertension, diabetes, stroke and heart disease e and requires general practitioners to use these guidelines when managing chronic diseases. however, deficiencies in continuous professional development and a lack of evidence-based guidelines have created further problems in delivering cost-effective interventions for chronic disease prevention: "the rate of adherence to these guidelines is low due to poor understanding and co-operation. it is necessary to make recommendations for these diseases by means of a process of critical appraisal and consensus building." regarding maternal and child care, the interviewees said that chs organizations assisted local women's and children's health organizations in carrying out related programmes, such as health education and counselling, screening, followup and referral: "childhood immunizations were implemented at the highest rate. it is estimated to be e %." "now, cost-free screenings for breast cancer and cervical cancer for adult women are delivered in some districts according to local government's regulations." when asked about geriatric care and care of persons with disabilities, all directors replied that the instruction of self-care and the management of chronic diseases were emphasized for the elderly, and that exercise sites have been gradually upgraded by supplying physical rehabilitation equipment for disabled people. health education is delivered regularly in the context of supplying other health services. most of the respondents agreed that illness-oriented visits were the most important opportunities to deliver health habit counselling and education to patients, but that this was done less frequently during health maintenance visits. the directors agreed that tobacco cessation counselling and exercise advice were the most common health education topics covered by doctors and patients during illness visits. an average of £ . (at a conversion rate of . rmb to £ ) per person per year was provided for basic public health services in beijing since , and each district government supplied different amounts of money for basic public health services in its communities according to its economic level and population. however, basic public health services were often perceived as not being reimbursed proportionately to the amount of time expended, particularly when they were opportunistically added to illness visits. the directors conveyed the opinion that funding for basic public health services was insufficient, and that most of the funds were spent on correlative public equipment and expendable items: "few financial incentives are paid to the individual health services.this may be an important reason why we can't motivate providers to deliver more and higher-quality basic public health services." "there is a higher percentage of migrants in some districts such as chaoyang, fengtai and haidian, but no exact budget support from beijing municipal government for migrants except immunizations. part of public health services, such as health education, communicable diseases management are delivered for migrants in some districts, financed only by local government. the municipal government needs to think over the problems brought by migrants." providers who deliver basic public health services teams consisting mainly of general practitioners, community nurses and public health specialists deliver basic public health services in the community. in addition to supplying medical care, general practitioners are required to delivery cost-free clinical preventive services for individuals and families, and population-based public health services (appendix ). their roles include being exemplars for health; providing assessments; serving as educators, counsellors and evaluators; and making referrals when necessary. public health specialists, who serve as recorders of health data as well as health educators, are responsible for public health services for populations in their communities. community nurses mainly assist general practitioners and public health specialists. "basic public health services often were actually delivered by allied health professionals who may be more effective than physicians in initiating and carrying out many public interventions." due to the broad scope of basic public health services and limited financial incentives, providers felt that they were under great stress and harried by many competing demands for their time. it is unrealistic to expect that basic public health services would be improved by placing additional burdens on providers without removing other demands: "time constraints and the short supply of public health service providers are barriers to the delivery of prevention. furthermore, there are considerable gaps in knowledge and experience about public health among community providers. most of them don't realize the importance of delivering public health services for residents in community. individuals charged with making policy recommendations and increasing the delivery of basic public health services must acknowledge this fact." medical staff in community settings often complained that community members for whom they were responsible did not trust them as these clinicians had lower levels of knowledge and skill than specialists. as a result, community members are often reluctant to accept basic public health services: "young people especially, who seldom see general practitioners, do not know clearly which basic public health services are supplied by chs organizations. as a result, they often do not trust and refuse these community-based services, so patient noncompliance is one of the chief constraints to the improvement of basic public health services." the directors complained that some public health services, such as aspects of mental health care, pest control and endemic disease management, should have been supplied by other organizations but were passed off on the chs. as staff competency for these tasks is low, the quality of these services is low as a consequence. basic public health services delivered in the community should be creative, adaptive and responsive to local needs and expectations, including those of patients, community, local healthcare institutions, staff and doctors. it is necessary for beijing municipal government to further elucidate the content of basic public health services and define the priorities in which services need to be delivered according to the needs of local practices, their patients and their communities: "certainly, it is difficult for medical staff in the community to deliver so many public health services with high levels of quality . the governments should prioritize the delivery of services according to patients' risk factors and preferences, practical considerations and financial budget." beijing municipal government is planning to increase funding for basic public health services to £ per person in . the directors considered that this was still insufficient and advised that the municipal government should increase providers' salaries and subsidies. for example, an additional duty hour allowance scheme should be brought forward, under which health workers would be allowed to work extra hours and receive pay to augment their salaries: "besides payment, of course, some changes in the process and organization of the providers' work are also part of the solution to the problem of the under-provision of basic public health services.a useful solution to attract more community residents to see general practitioners would be to increase the proportion of medical reimbursement for chs services." recruiting more competent medical staff there were . million residents and . million migrants in beijing in . in , the total number of medical staff in the entire beijing community was , (source: beijing statistical bureau, ). of these, were general practitioners, were public health workers (including public health specialists) and were nurses. staffing patterns differed from district to district. however, there was consensus among the directors that more medical staff need to be allocated to chs organizations. there is a large disparity between general practitioners and specialists in salary and opportunities for promotion. many doctors and nurses with better educational backgrounds or higher professional titles prefer to work in hospitals. it is difficult to recruit competent medical staff in the community. the directors advised that the governments can attempt to attract better qualified doctors to work in the chs by raising salaries, providing more opportunities to participate in continuing medical education programmes and academic conferences, and shortening tenure periods for promotion to higher professional titles. in addition, emphasis was placed on the need to increase team work among chs workers or between chs providers and hospital-based specialists. china has made great efforts to improve the health of its huge population, and has had considerable success in this endeavour. for example, longevity has increased. compared with years in , life expectancy had increased to years in both sexes in (source: ministry of health of china, world health organization, ). , however, excessive healthcare costs and inconvenient access to health care are still major healthcare problems in china. in order to resolve these problems, china has initiated a new approach which includes improving primary healthcare facilities and offering equitable access to basic public health services across the country. many provinces and cities have followed these regulations and are devoted to developing core communitybased public health services. accordingly, beijing municipal government has drawn up a series of protocols À to support basic public health services for its residents. as the tie that links district governments and chs organizations, the district mcchss are at the front line of implementation of the plan to deliver basic public health services in community settings. this study found much valuable information by interviewing the directors of the mcchss. the chinese government is supplying nine types of basic public health services, including specific services, at no cost for all people since according to its announcement. since , chs organizations in beijing have supplied more basic public health services for residents than those required by the national plan, and basic public health services are regarded as part of a core mission in general practice. however, the delivery of some of these basic public health services was at lower levels of quality than is desirable. this finding is consistent with the reports of other researchers about preventive services delivery in other countries. , in general, locally tailored interventions are more likely to be adopted into the usual routines of practice than interventional approaches that are dependent on outside stimuli (such as financial incentives), or which impose practice tools and approaches developed elsewhere. it is imperative to undertake more research to find ways to make these improvements. according to a policy statement, the chinese government and local governments at all levels will provide financial outlays that are not less than £ . per person per year for basic public health services for all chinese people in , and increase subsidies to achieve universal insurance coverage and to assure every citizen equal access to affordable basic health care. year. the budget in beijing is £ . per person per year since ; however, beijing chs centres are required to deliver more basic public health services than their counterparts in other provinces. the deficiency in funding has become such a problem that some basic public health services cannot be implemented effectively in beijing. the municipal government is now assessing how much money should be devoted to basic public health services on the basis of its funding capability and the demands of stakeholders. in addition, migrants need to be recognized as a specific target group for health promotion, prevention and health care, and the governments should provide additional funding for them. these findings are consistent with research which points out that multidisciplinary practice teams are key to delivering basic public health services in community settings. successful teams are created through formulating inter-related goals, identifying measurable outcomes, systematizing routine tasks of care, defining provider tasks and roles explicitly, and providing appropriate training. a document published by the state council of china in mandated that the allocation rate for medical staff working in the chs should reach the level of two to three general practitioners and nurses per , residents, and one public health specialist per , residents by . in beijing, the allocation is one general practitioner per residents, one nurse per , residents and one public health specialist per residents. in fact, the above allocation rates have not yet been met, especially since the demand for much of the scope and quality of public health services has increased. in addition, the low levels of chs providers' knowledge and skills is a major problem. as a result, basic public health services are often only provided in response to patient requests or obvious needs in beijing; services thus tend to be reactive rather than proactive. it may simply be unrealistic to expect community providers to deliver a comprehensive package of basic public health services along with the many competing demands of providing direct clinical care. in view of the reasons mentioned above, beijing municipal government is planning several programmes to improve the service capabilities of the chs providers. these include partial changes in the structure, roles and functions of the teams; incentives to attract more medical graduates to work in community settings; redistribution of tertiary hospital doctors to chs organizations; reemployment of retired doctors in the chs; and the provision of financial support and opportunities for younger doctors to get better continuing medical education. the roles and experiences of both medical staff and their patients also impact on health promotion activities. the community resident/patient is not a passive participant in the process of receiving basic public health services, and many residents look to providers for guidance and direction in the prevention of diseases. favourable interaction between providers and patients is critical to the effectiveness and efficiency of the delivery of basic public health services, because in some types of preventive services, the patient's contribution may ultimately be more significant than the provider's role (e.g. weight loss, smoking cessation, reduction of alcohol use, adherence to medical regimen). people with insurance can access other services which are not free of charge in chs organizations. in fact, people with insurance prefer to visit doctors in hospitals to chs organizations. in order to attract more people to visit the chs, chs organizations are required to supply acceptable services by decreasing drug prices and increasing the proportion of medical reimbursement. beijing municipal government is currently devoting significant funding to publicizing basic public health services in the community by means of various media, and is encouraging residents with common diseases to see general practitioners. this exploratory study provides in-depth examinations of the status and barriers of basic public health services provided in community practices. interviews were carried out and analyzed by a multidisciplinary group in order to maintain the validity and meaningfulness of the results. purposeful sampling was used to enhance external validity or transferability. however, the findings must be interpreted in the context of the study's limitations. the data were crosssectional in nature. the possibility that the non-responding directors were different from the interviewed directors can not be excluded. the study examined basic public health services from the perspective of supervisors, who do not themselves provide direct primary medical care. it did not examine the broader frame of basic public health services in the community and overall population levels. the fact that all the data for this study were collected in one city may call into question its generalizability to other locales. however, the choice of beijing as the site for data collection has particular significance to healthcare service delivery in china because the nation's capital was one of the first cities to comprehensively implement the chs reforms of , and thus has had the longest experience with them. in addition, beijing has traditionally served as a national test site for reforms of the chs. accordingly, the authors recommend that further research should be undertaken on the delivery of basic public health services with larger sampling from community providers from other cities in china. this qualitative study suggests that the emphasis of beijing municipal government on the delivery of basic public health services in community settings is an important effort, but the specific parameters for these services should be clarified, the quantity and quality of staffing must be addressed, sufficient time for provision of services must be allowed, and sufficient funding must be provided. the authors believe that major reforms of the healthcare system in beijing and china are needed to address these problems. the state council of the people's republic of china. the guidelines of development of community health services in urban areas the state council of the people's republic of china. the suggestions of deepening reform of public health and medicine undertaking human resource staffing and service functions of community health services organizations in china public health in china: the shanghai cdc perspective china's health 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suggestions for promoting of community health services in beijing beijing municipal health bureau. the implementing suggestions of training the human resources in general practice the suggestions for strengthening human resource staffing in community health services organization direct observation of rates of preventive service delivery in community family practice a qualitative study in rural and urban areas on whether e and how e to consult during routine and out of hours sustainability of a practice-individualized preventive service delivery intervention public health in primary care trusts: a resource needs assessment china's health care reform: a tentative assessment department of the health care for women, children and communities, ministry of health of china challenges of change: a qualitative study of chronic care model implementation consequences of international migration: a qualitative study on stress among polish migrant workers in scotland ministry of health of the people's republic of china. the distribution standards of human resource staffing and community health services organization settings economic incentives and physicians' delivery of preventive care: a systematic review people's republic of china: ministry of labour and social security. the suggestions of encouraging people with health insurance to get chs services qualitative evaluation and research methods investigation reports of community health services in beijing follow-up . intelligence, dental, hearing and vision screenings . growth and development assessment, monitoring and counselling . psychological development counselling . health status assessments . nutritional counselling . communicable diseases reporting and management in preschools . disinfection management in preschools . maternal care (women's care) . public awareness and professional education, providing health advice and support to young mothers . establishing records . examination of early pregnancy . perinatal high-risk management . follow-up of the prenatal and postpartum periods . prenatal/postpartum care . referrals . gynaecologic diseases, breast and cervical cancer screenings . family planning . education and consultation . provision of information on contraception . financing contraception . surgery for birth control help people to develop their understanding and skills to improve their own health . raising public awareness of the early symptoms of diseases . reduction in inappropriate antibiotic use . multitopic health promotion campaigns centre for disease control and prevention the authors wish to thank liguang sun for his help in coordinating work, gang liu for supplying some policy information for the interviews, min liu for sharing her expertise in the interview guide, qiongying wang for her help in organizing the data, and kenneth kushner and o. daniel smith for their astute editorial suggestions. the authors would also like to thank the participating directors for their contributions to this project and their commitments in the study. r e f e r e n c e s medical ethics committee of capital medical university. none declared. none declared. free basic public health services delivered in community health services organizations in districts in beijing since . key: cord- -mqbud t authors: tambo, ernest; madjou, ghislaine; khayeka-wandabwa, christopher; tekwu, emmanuel n.; olalubi, oluwasogo a.; midzi, nicolas; bengyella, louis; adedeji, ahmed a.; ngogang, jeanne y. title: can free open access resources strengthen knowledge-based emerging public health priorities, policies and programs in africa? date: - - journal: f res doi: . /f research. . sha: doc_id: cord_uid: mqbud t tackling emerging epidemics and infectious diseases burden in africa requires increasing unrestricted open access and free use or reuse of regional and global policies reforms as well as timely communication capabilities and strategies. promoting, scaling up data and information sharing between african researchers and international partners are of vital importance in accelerating open access at no cost. free open access (foa) health data and information acceptability, uptake tactics and sustainable mechanisms are urgently needed. these are critical in establishing real time and effective knowledge or evidence-based translation, proven and validated approaches, strategies and tools to strengthen and revamp health systems. as such, early and timely access to needed emerging public health information is meant to be instrumental and valuable for policy-makers, implementers, care providers, researchers, health-related institutions and stakeholders including populations when guiding health financing, and planning contextual programs. in recent times, the persistence and unprecedented emergence of rising epidemics and infectious diseases in africa and worldwide triggered numerous public health declarations of international concern . these local and global uncertainties and potential consequences have prompted questions and reflections on the usefulness and implications of unlocked and unprocessed available massive database resources from different national, regional and international funded projects overtime in low and middle income countries (lmics) and particularly in africa. can free open access (foa) to these valuable resources improve evidence-based decision making policies, health planning and adequate funding allocation, innovative programs and strategic interventions performance and effectiveness to most vulnerable populations' health and socio-economic benefits? emerging and re-emerging infectious diseases epidemics are rampant, ranging from ebola, influenza, lassa fever, hiv sars and mers-cov, zika to other zoonotic diseases existing as potential threats with sporadic epidemics in old and new regions , . there is a need for availability of data and information on humanvector-pathogen-ecosystem interfaces, drugs and vaccines development as well as diagnostics techniques and tools from preclinical to clinical levels. it is critical that the information is used in an equitable, ethical and transparent manner. operational research projects in libraries, national archiving, journals, local and international , scholarly institutions and centers are partially or yet to be fully tapped into maximizing and ensuring improvements of health and disease information, knowledge and empowerment for all generations . previous literature reviews have shown that open access data and information are of great importance and valuable assets in information sharing, education exchanges and capacity development. this foa necessity has practically been laid bare by the recent from west africa ebola to zika epidemics crisis where experts across fields including clinical ' neonatal and pediatrics have been challenged. henceforth, academic journals, libraries sources, local and internal non-governmental organizations (ngos) data, data from research funded or non-funded projects, centers and institutions should be committed to foa data and results sharing relevant to the current zika public health crisis and future emergencies for rapidly emergency mobilization and response. moreover, the approach has proved to be useful in translation and application of proven and reliable knowledge in guiding effective decision making policies, lifestyle adaptations and contextual programs and strategies in improving public health social economic development and well-being of local and global community , , , . most data and information often used in global policies and initiatives are either guaranteed as free by the world health organization (who) and partners philanthropic organizations, whereas the bulk of support references and documents are not readily accessible to most african scholars, but mainly to policy-makers and implementers . equally, limiting access to younger generations of researchers and students who cannot afford the fee to access publication in high impact placed journals, provide highly condensed information not easily informative to those in much need. the free open access core concept can be characterized by removal of price barriers, no subscription fees and permission barriers, no copyright and licensing restrictions to royalty free literature, to make data and information available to all populations , . "fee free open access to health data and information for all generations offers a new public health paradigm shift and opportunities to meet the knowledge, lessons learnt and experiences gaps and needs in africa. advocacy and mitigation on lack to limited access of existing and emerging data, and information sharing is necessary in embracing regional and global open access. these novelties in information sharing approaches towards collective learning and participative engagement for sound knowledge and empowerment for better health, information exchange for equity in quality education and utilization are paramount for human and societal benefits. it is of fundamental importance to increase multi-disciplinary and inter-sectoral partnerships and collaborations not only to understand and fill the gaps through joint or independent research, but also to be able to use and mine unrestricted data and information for public health good, economic growth and sustainable development , . although decades of funded and non-funded programs and projects in both developed and developing countries have generated millions of publications and databases on emerging and infectious diseases of poverty , , . the impact of policy-translation of lessons learnt and experiences gained are seldom and limited in applications mostly in developing countries. as most lmics are still challenged with weak health systems and low literacy mainly in remote rural areas and areas of political instability, inadequacies in health funding allocation and resources capacity, poor accountability and governance are present. moreover, inefficiencies in management and lack of a multi-sectoral approach to access and use local or national data repositories in a structured manner prevent both mainstream national and regional economic development . furthermore, the usefulness in forecasting, prevention and management or smart response of emergency situations and disasters are yet to be fully documented and demonstrated in africa. foa viability and benefit in most tropical endemics and epidemics-prone developed and developing countries affirmed that the vast majority of metadata and database platforms are still locked (inaccessible and unavailable) for public use and untapped to global community multi-dimensional gains. increasing unrestricted and foa use or reuse as well as timely reporting or communication capabilities strategies are urgently needed in promoting and scaling up data and information sharing and exchange between african researchers, partners and collaborators , , , . the strength of scaling foa in developing countries will entail but not limited to: ) increasing real time and effective knowledge-or evidence-based translation of proven and validated approaches, ) strategies and tools in strengthening health systems and revamping early and timely access to much needed information by policy-makers, and ) enhanced guided health financing and capacity development by health institutions and related stakeholders, and strengthening contextual programs and activities planning, transparency and accountability. this paper assesses the values and benefits of open, free of charge data and information access and availability in strengthening health systems policies, financing, promoting knowledge-based programs and targeted interventions directed to forecast, prevent, reduce and/or manage the growing emerging threats and epidemics as well as infectious diseases of poverty in lmics, especially in africa. the growing burden of emerging epidemics and infectious diseases have been documented in demoting health systems in rural and urban settings in africa. it is important to assess and understand why and how open data and information access is needed in the context of health and diseases epidemics. also, what capacity development and training are needed to translate these various valuable datasets and database assets if freely available into knowledgebased innovations needed to revolutionize africa and global health capabilities, and opportunities to prevent and control emerging epidemics and infectious diseases of poverty , , , . the current trends of globalization of trade and travel, intense urbanization, economic slowdown are coupled with rising of double epidemics burden (emerging infectious diseases and chronic diseases). thus, there is an urgent need for open data and information access promotion, advocacy and awareness. this is critical in strengthening and improving the strategic value and usefulness of knowledge-based innovations, teaching and learning, key sources and assets of policy transformation oriented research and primary care innovations (e.g., routine to universal immunization, essential medicines and nutrition). adopting and adapting open access proven lessons learnt and experiences to alleviate sufferings and poverty, health literacy access and delivery inequities amongst vulnerable populations in africa is very important , , , . the evolving use of electronic data and digital delivery platforms to support open access interactive literacy, communication and empowerment of health is a vital need in increasing care acceptability, uptake and scaling up positive cultural ad behavioral changes relevant for communicable and non-communicable diseases vigilance and resilience , , . however, with restricted content access, such anticipated evolution in terms of accurate timing and relevant knowledge among experts remains to be a blatant wish as technology and information are not mutually exclusive. digital technology is only but a driver of available content and hence it thrives, and finds usefulness in the context of information, particularly transformative evidence for universal global health resources access and sharing benefits for all. health financing or national resource allocation requires as much open data and information access, analysis, effective and reliable interpretation for outcomes-based sustainable and equitable early decision health financing and funding in achieving local and regional universal health coverage (uch) and sustainable development goals (sdgs). moreover, this new paradigm has the capacity to strengthen and allow exploration of potential local and national health systems, insurance schemes implementation, uptake and coverage impacts as well as legislative and institutional reforms and regulations to enable community and stakeholders commitments and investments , . proactive efforts in promoting radical data and information openness and defining criteria tailored to sharing capabilities and transparency are critical and innovative approaches to create monetary and non-monetary benefits , . data-driven approaches and strategies provide an immense opportunity to understand, define and generate databases that can be used for predictive primary care and innovations in the short-and long-term in diverse scenarios , . in order to attain and optimize the pan-africanism aspiration to foa to current findings and evidence that help shape our decision making process, it is imperative to consolidate online platforms and resources to one stop shop for evidence in different genres. since timely access to accurate data and information are essential to improving the quality of knowledge and intervention effectiveness, to information scientists alongside librarians globally. predominantly, with the challenges of electricity shortage and costly internet services, most open access african users' tendency is increasingly familiar with google and other internet search engines to discover or access information. hence, any foa platform should be user-friendly, non-bias choice, interoperability and flexible. that is, accessibility should not depend on articles being accessed via a special portal or proxy server or publishing platforms, or via complex authorization systems, but should be readily and freely available to all re-users or users consumers and redistribution within the ethical and legal framework. information should be readily reached without barriers targeting all cadres of technocrats from those with basic training and skills to the advanced. tested models have proved this relevance and lesson for progressive improvement can be adopted , , . one of the implications of not doing so is not being able to find information easily using online systems , , . consequently, researchers and policy-makers and implementers in lmics have to spend enough time to be informed, consolidate and synthesize what types of information and knowledge can be adaptable, scalable, cost-effective and translated in intervention and best practices , , . as a way out in many occasions, when we develop policies for research and programs delivery, we as institutions or individuals take slightly different routes to find the evidence that helps shape our decision making. we often end up relying on a restricted range of platforms, consortia systems and institutional networks that are only readily available small scale data and database evidence online . hence, without objectivity and in absence of credible context relevant platforms, we are prone to use biased and/or misplaced approaches policies particularly in the health systems improvement endeavor , , . foa platforms prospects are multiple to african scholars, researchers and their collaborators real time and frontline data and other research outputs contextual determinants and scenarios will preferentially entail consolidating r&ds that are alternatives to the prevailing publishing proprietary models to support open access to health resources. for instance, prioritization databases combine available genomic, genetics and bioinformatics data for each priority genre with automatically extracted and manually curated information for genetic counseling to personalized medicine. also, in questioning or responding to further literature and other databases research gaps relevant to clinical and analytical practices, putative drug and vaccine target(s) discovery for threatening chronic diseases. investing substantial efforts in open database mining also permits prioritization, actionable and customized evidence, potential drug and vaccine targets discovery , , , . such harnessing may entail the development of research and innovation portfolios focusing on critical public health gaps where traditional approaches are failing, and leveraging proven evidence and lessons learnt on what works and what does not work. as such, the aim would be to attain a long term health agenda and capacity building mitigation via research approaches, cost-effective, timely and progressive innovations , . authors advocate to governments, policy-makers and implementers, researchers, academicians, health professionals and other stakeholders including the community to endorse open access public health resources platforms implementation at all levels. there is also need to develop appropriate mechanisms and strategies to promote open access capacity building and empowerment, enhanced health and disease literacy and education through sharing and exchanges, innovative policies and frameworks with advances in digital technologies, establishment of data and information quality control and assurance principle and guidelines, well-coordinated and coherent metadata and database management for evidence operational research and clinical decision making interventions , . the value and credit of foa does not only promote health and disease literacy, but offer opportunities for mutual sharing of various educational materials, learning and empowerment on maximizing on the use or reuse of the data mining and managed for short-and long-term public health benefits, global health security and wellbeing. foa agenda to health workers, professional and providers and communities offers new opportunities in providing affordable, robust, real time and free user friendly and sustainable datasets and databases , , , . while proactive efforts in reducing or minimizing the various barriers and challenges of foa uptake and implementation capacity including intellectual property rights, confidentiality, legislation and data use agreements amongst stakeholders (including the lay communities, institutions of learning and studentships) still persist, the value of open access is real , , , . the value of freely accessible and available scarce and/or other profuse data, database and information through foa for public health systems offers tremendous opportunities to strengthen and fasten emerging threat and epidemics including persistent infectious diseases of poverty modeling in preparedness, prevention and control. moreover, promoting robust evidence-based health and disease surveillance, response planning and funding underscore the social, ecological and economic burden, and opportunities for governments, stakeholders and vulnerable populations , , , , , . nonetheless, foa and information sharing potential benefits and gains should include but not limited to: ( ) enhancing new public health paradigm and innovations in collective and participative education, timely reporting and increasing dissemination and effective trans-boundary risk communication towards democratization of heath data and information for quality health and wellbeing. ( ) accelerating proven acceptability and uptake tactics and sustainable mechanisms such as expanded vaccine(s) immunization or mass drug administration in scaling up the coverage and effectiveness to prevent disability and death; uses of wearable technology and sensors in early detection, tracking and monitoring of vectors and/or pathogens and management of associated diseases including non-communicable diseases mitigation and lifestyle adaptations strategies. ( ) upholding continuous open access resources advocacy, education and awareness for all in securing universal health coverage, sdgs and "foa health information for all generations". ( ) nurturing new commitment and investment in novel proven approaches, methods and tools in strengthening local and regional health systems capacity development (infrastructures and resources) in operational and translation research from diverse resources and sources. ( ) promoting the value of free, real-time data and information access and availability to all parties in transforming knowledge-based translation into health policy decisions and guiding health priorities financing and public health actions. ( ) improving integration and use of information to support evidence-based integrated public-private health and related sectors partnerships (local private sector, bilateral and multi-international) and community-based programs and projects participative ownership. ( ) fostering innovative interventions and best practices amongst professional, health workers and the community resilience and participative engagement in response to emerging threats and disasters. ( ) facilitating lifetime interactive learning, increasing knowledge, empowerment and resilience in emerging epidemics and infectious diseases vulnerability surveillance and monitoring measures. ( ) promoting ethical, legal and international regulations and by-laws applications in safety and security. ( ) promoting local, national and regional "one health" approach in tackling in integrated manner regional and global epidemics of zoonotic infectious diseases prevention, preparedness, control and elimination agenda integration, uptake and utilization for impact. author contributions et conceived the idea, researched the literature and initiated the primary draft of the manuscript. et, gm and ckw contributed to review the literature. et, gm, ckw, ent, oao, nm, lb, aaa and jyn provided further inputs. all authors read and approved the final manuscript. no competing interests were disclosed. the author(s) declared that no grants were involved in supporting this work. the authors have addressed the highly important issue of free open access (foa) as a means of tackling emerging epidemics and infectious diseases burden in africa. they argue that unrestricted open access and free use or reuse of relevant and appropriate data together with sharing of data among african researchers, international partners, policy makers and the community will help limit the effect of burden of infectious disease epidemics in africa. availability of real time information on virtually all aspects of infections and diseases is required for timely action and response needed to ensure that public health events do not escalate to international concerns with grave consequences. it must be however observed that unrestricted free open access to data may lead to users being overwhelmed and unable to make sense out of the data, unless there is available capacity and capability for appropriately analysing and synthesizing the data into valuable information for policy-makers, implementers, care providers, researchers, health-related institutions and stakeholders including the community. this requires increasing and improving human resource capacity side by side with the call for unrestricted free open access. i find the review stimulating and challenging, with title and abstract matching the contents and conclusions which focuses on the benefits of foa. as they call for foa, they also call for the need for unrestricted but planned collaboration between all stakeholders under the "one health" umbrella. no competing interests were disclosed. competing interests: are press depictions of affordable care act beneficiaries favorable to policy durability? cumulative environmental impacts: science and policy to protect communities open access to research for the developing world lessons learned from scaling up a community-based health program in the upper east region of northern ghana pubmed abstract | publisher full text | free full text active patients in rural african health care: implications for research and policy improving online access to medical information for low-income countries health professionals for a new century: transforming education to strengthen health systems in an interdependent world organization wh: strengthening health systems to improve health outcomes. who's framework for action which knowledge? whose reality? an overview of knowledge used in the development sector promoting open access to research in academic libraries open access in south africa: a case study and reflections research evidence and policy: qualitative study in selected provinces in south africa and cameroon version this article was carefully thought of by the authors in relation to the current disease burden faced by the world and its people. the concept of foa as a driving force for better networking on the knowledge of disease burden, has been an area of concern by researchers, health organizations and the various government bodies around the world. research based information generated by different labs using high throughput information has been the driving force for obtaining large funding, reasons why the published information cannot be freely accessed in some journals. the resulting challenge is the lack of implementation of the right approaches to disease outcomes in lmics due to low comprehension of the disease epidemiology and genetic factors. there is actually need for world governing bodies to sit at their conferences and make foa a priority so that researchers in lmics, through documented information in accessed journals, could collaborate with authors who have published widely in related fields of interest, helping them contain the disease epidemic using the right approaches before it spreads. the world now is a global village and should be treated as such, hence institutions at all ends of the globe should be able to create some form of partnerships for training and sharing data for the advancement of better health for all.the authors actually focused on their indicated topic and brought out related challenges, which suggests reasons for poor approaches to the current disease burden. their proposals highlight steps which every player involved in decision making at various levels of the disease burden for better health, need to consider for us to attain the health goals put in place.i recommend this article as a document for all involved in the research and health field. no competing interests were disclosed. key: cord- - isk jgj authors: fix, gemmae m.; reisinger, heather schacht; etchin, anna; mcdannold, sarah; eagan, aaron; findley, kimberly; gifford, allen l.; gupta, kalpana; mcinnes, d. keith title: health care workers’ perceptions and reported use of respiratory protective equipment: a qualitative analysis date: - - journal: am j infect control doi: . /j.ajic. . . sha: doc_id: cord_uid: isk jgj background: little is known about health care workers’ (hcw) perceptions of, or experiences using, respiratory protective equipment (rpe). we sought to characterize their perceptions and identify reasons underlying inappropriate use. methods: we conducted focus groups with nurses and nursing assistants at medical centers. we analyzed the thematic content of discrete “stories” told by focus group participants. results: we identified story types surrounding rpe use: ) policies are known and seen during work routines; ) during protocol lapses, use is reinforced through social norms; ) clinical experiences sometimes supersede protocol adherence; ) when risk perception is high, we found concern regarding accessing rpe; and ) hcws in emergency departments were viewed as not following protocol because risk was ever-present. discussion: hcws were aware of the importance of rpe and protocols for using it, and these supported use when protocol lapses occurred. however, protocol adherence was undermined by clinical experience, perceived risk, and the distinct context of the emergency department where patients continually arrive with incomplete or delayed diagnoses. conclusions: protocols, visual cues, and social norms contribute to a culture of safety. this culture can be undermined when hcws experience diagnostic uncertainty or they mistrust the protocol and instead rely on their clinical experiences. advanced respiratory protective equipment (rpe), like powered air-purifying respirators and n respirators, are critical for protecting health care workers (hcws) from contracting and spreading airborne infections. proper rpe use reduces risk, yet existing research documents low adherence. moreover, the emergence of pathogens such as ebola and severe acute respiratory syndrome (sars), has raised awareness of the importance of respiratory protection. , although much work has been done to understand how discomfort (eg, facial pressure, shortness of breath) might affect use, [ ] [ ] [ ] [ ] [ ] less is known about how beliefs, perceptions, or work experiences might influence protocol adherence. understanding what contributes to a system-level safety culture can ensure that when more significant pathogens are present, and increased n use is needed, barriers to use can be systemically addressed. hcw adherence to respiratory infection control guidelines, including vaccinations, are known to be influenced by personal and contextual factors, such as knowledge gaps, perceived risk, ethical and legal concerns, and economic issues , health behavior theories, such as the health belief model, have been used to examine adoption of health-related behaviors. health belief model constructsperceived severity, susceptibility, benefits and barriers to the health behaviors, perceived threat, cues to action, self-efficacy, and demographic factors-may inform whether protective action is taken. the health belief model has been previously used to understand use of respiratory protection. , these studies found that perceived seriousness and perceived susceptibility were major factors in hcw decisions to wear respiratory masks during a sars outbreak. however, there may be other unexplored factors impacting respiratory protection use. we therefore sought to characterize perceptions of rpe, identify reasons for use, and examine how work routines might impede or facilitate protocol adherence. we used a qualitative study design to examine hcw's perceptions and reported rpe use. we focused on registered nurses (rns) and nursing assistants (nas) because they provide frontline care, spend significant time with patients, are frequently exposed to infectious agents, and thus are more likely to require rpe. , this design facilitates identifying previously unknown issues from the participants' perspectives. importantly, whereas some responses may not be "true," the perception of their veracity may still inform behaviors and highlights the use of our qualitative approach. for example, transmission routes described by an hcw may not be biologically plausible, yet this understanding may inform rpe use. we recruited from hospitals in the northeastern and midwestern united states ( veterans health administration and academic medical center per region). local contacts at each hospital provided eligible participants from adult inpatient medical, surgical, and intensive care units, and emergency departments (ed) information about our study. focus groups were restricted to na only or nurse only; however, they could provide patient care in any of the targeted recruitment units mentioned earlier. focus groups often had more than nurse or na from a particular unit. originally, we planned focus groups per hospital, each with nas and rns. however, an international ebola outbreak spurred an additional focus group at each hospital of rns who had ebola prevention training. the focus group guide (see appendix), informed by the health belief model, covered experiences using rpe (cues to action), reasons for use (perceived benefits and barriers), experiences with rpe (perceived seriousness and susceptibility), descriptions of situations when masks were not worn (motivating factors), and comfort and usability (motivating factors). we brought n s and surgical masks to the focus groups. we focused questions and analysis on n s. after obtaining informed consent, focus groups were audio-recorded and transcribed. participants completed a survey about their employment and whether they had been fit tested or received rpe training. study procedures were approved by the hospitals' institutional review boards. we used a qualitative analytic strategy, initially guided by the health belief model. however, during data review, we noted the health belief model, which is a useful heuristic to organize the data, was insufficient to fully capture the rich narrative content of the data. we noted data were comprised of short stories relating to events surrounding rpe use. to take advantage of this data and reduce disaggregation of the findings, we organized the data into "story units," defined as segments of text with a beginning, middle, and end. our team subsequently analysed transcripts looking for discrete "story units." two team members independently reviewed each transcript and delineated the stories using a template. each templated story was given a title, summary, and discussed by the full team. we then conducted an inductive thematic analysis of these stories, sorting them into different story types. we noted when participants brought up droplet or contact precautions. nurses with advanced training* . - nursing assistants - vha, veterans health administration. *the focus groups were conducted at a time of heightened awareness of ebola. these nurses received advanced training in triaging and caring for patients with potential ebola. we conducted focus groups (table ) . across the focus groups, we identified discrete stories about rpe use, which we organized into categories: ) participants knew their sites' rpe policies and protocols. they described visual cues, such as signs resulting from these policies encountered during work routines that promoted rpe use. ) sociocultural norms reinforced rpe use, particularly during unexpected events. ) hcws used their clinical experiences to determine use, sometimes opting to wear more rpe than required. ) additionally, risk perceptions varied by rural and urban contexts. in urban areas, for example, hcws who perceived exposure to many high-risk patients reported limited access to rpe. finally, ) perceived underuse in the ed was attributed to the constant presence of patients with incomplete or delayed diagnoses. further descriptions of each category are in the following paragraphs. following hospital rpe protocol was considered part of the job. when asked about not wearing rpe when required, a site participant replied, "that's not an option." participants specified clinical indications that necessitated rpe, including a medical evaluation to "rule out" tuberculosis (tb), ebola, sars, middle east respiratory syndrome, meningitis, or upper respiratory infections. participants' stories included a variety of cues prompting rpe use, including door signs on patient rooms, personal protective equipment carts in front of patient rooms, documentation in the electronic medical record, and patients being in a negative air pressure room. a site participant recounted common cues, signs, and nurse reports: "we have a big sign on the door that says 'airborne precaution' and it will tell you some things that you have to wear, so when it says airborne precaution you know that you have to wear a mask and things like that. and on report, before we get to the room, you need to get report from the other nurse that was taking care of that patient so the report will tell you. . .what to do before you get in." several stories described scenarios highlighting how it was socially acceptable to identify lapses in following the rpe protocol. wearing rpe was consistently recognized as "one of the things that you have to do," despite rpe being "suffocating" and "claustrophobic." these feelings could be acute when the nurse had an upper respiratory infection, which meant "you actually can't breathe at all [with rpe on]." despite discomfort, a common sentiment was that rpe was protective, as a site na said: "i wouldn't wanna wear [rpe] all the time. but they're manageable, and i'd rather have them on than have them off." the safety culture could be seen in practice. when lapses in protocol adherence occurred, hcws were enculturated to enforce the policy. at site , several participants told a story about a non-english speaking patient with tb who became hypoxic and disoriented, coughing up blood-tinged sputum as he unexpectedly emerged from his isolation room. several hcws quickly gathered, and whereas some began providing direct care, others, who sensed the risk of infection, began yelling to colleagues, "put a mask on! put a mask on!" in another story, site participants described how a food service worker walked into a negative pressure room without a respirator, despite an "airborne precautions" door sign. after informing this individual, the nursing staff reported the event to supervisors who helped organize a respiratory precaution training for food service staff. beyond protocols, participants evaluated patient behaviors and symptoms to determine whether to wear rpe. this meant they might decide to use rpe even if protocol specified droplet or no precautions. often, patient symptoms served as a cue to don rpe; "yeah, i've put [rpe] on if someone is coughing so forcefully that it sounds like one of their organs is gonna come out. . .." [site ] similarly, several nurses at site recounted a series of symptoms that prompted "clinical judgement to kick in." one participant described likely exposures to tb because of patients being misdiagnosed with pneumonia: "it took a couple of events where i was exposed [to a patient who had an active, but undiagnosed airborne infection] and then i was like okay, i'm not gonna, you know, make that mistake again." now, with symptomatic patients, she dons rpe even when the working diagnosis does not require airborne precautions. historical, personal experiences also framed current use. a site nurse described her history wearing protective equipment: "hiv had just started to come out in , , and so we were trained not wearing gloves when you would do a bed bath. there were no gloves. . . . you would just clean your patient and wash your hands well afterward, so we had just been introduced to gloves as hiv came out in the ' s, early ' s, so the masks were, geez, like i can't wear that [laughing] . . . like when that was introduced it was a whole learning curve . . . and now we have this whole-body thing. a colleague noted that in light of current outbreaks, rpe use might increase, "it's not just ebola anymore. . .there's a lot more viruses coming down the pike. . .. we could end up wearing masks all the time at work." perceptions of risk, need for rpe, and access to equipment vary by context we found a relationship between risk perceptions, perceived access to rpe, and local context. participants reported varying degrees of exposure to patients with potential airborne infectious diseases, which in turn informed their perception of individual risk. for example, at sites treating more rural populations, participants reported few encounters requiring hcws to don airborne precautions and a lower perception of risk of exposure. they also described rpe as plentiful and accessible. a nurse at site described access to rpe, saying "they're everywhere." at another site serving rural areas, several participants described the multiple ways of ensuring equipment availability: in contrast, participants from urban sites serve populations with a higher prevalence of respiratory infections such as tb and perceive a greater risk of exposure when compared with the rural colleagues. as a nurse from urban site described, rpe was down a long hallway, "at the end of the universe." she noted having a "small face" requiring a small-sized mask, which was infrequently stocked. another nurse at site stated, ''they keep them [in another area] because they know how expensive they are,'' and further explained, "some people go to grab the yellow masks for droplet precautions and they might put on the n respirator for a droplet" perceiving that the hospital was trying to prevent hcws from mistakenly using a more expensive n instead of appropriate droplet precautions. uncertainty about diagnoses for patients entering the health care system through the ed participants described receiving inaccurate or delayed clinical information, for example, not knowing the patient had a potential airborne infection. this was especially the case for nurses working in the ed, who described distinctly different experiences. one site na noted, "it's a little scarier in the er [emergency room], just 'cause you don't know what they're coming with." similarly, nurses from other sites described the ed as different, too. a site nurse reported that when transferring a patient with a diagnosis requiring rpe from the ed, only the accepting department wore protection. she reasoned the ed staff not wearing rpe by saying, "they've kind of already been exposed to it, then it's too late." the ed was perceived as a place with less use of rpe, both because diagnosis was unknown, and this was attributed to ed staff being less likely to follow protocol. we conducted one of the few large, in-depth, qualitative studies of rpe use in hospital settings. , in focus groups, spanning hospitals, with rns and nas, participants described types of nonadherence. one was of rapidly evolving situations in which hcws were caught off guard, and unable to immediately don rpe. the other was related to an insufficient safety culture. importantly, each of these is modifiable to some extent through enhanced communication and multidisciplinary teamwork. the first type of rpe protocol nonadherence was not hcw oversight or ignorance, but rather unexpected actions by patients and other staff. illustrating this type was the story about a distressed patient with tb emerging from his negative pressure room without warning. hcws sprang to action to assist the patient, but without rpe. nearby colleagues, observing the potentially dangerous situation, quickly reminded the first responding hcws of the urgent need to don masks. another example of this type was a food service employee, apparently oblivious to precaution signs, walking into a patient room without the required rpe. similarly, hcws requested additional training for food service employees. these instances suggest the hcws felt empowered to speak up to colleagues when safety standards were not met. this indicates a pervasive safety culture, in which following protocols is habituated. this culture is created, as we and others have found, through trainings, leadership addressing safety concerns, peer influence, and tangible resources like accessible equipment. hcws appear to have the training to identify "moments of risk" and feel empowered to take immediate action to mitigate them. this type of culture and hcw empowerment has been associated with robust patient safety practices. , achieving the appropriate cultural among hcws, however, has been shown to be challenging in hospital systems perhaps undermined, as we found, by inaccessible equipment. the other type of nonadherence we found indicated limitations in the safety culture. we found problematic areas, as well as indications of how to address. in the first, some hcws did not trust the protocols and safety systems in place. instead they relied on their clinical experience to determine what protection to wear. several hcws we spoke with talked about wearing n s when the protocol specified a surgical mask. this was because they suspected, based on their clinical experience, that the patient might later be diagnosed with a respiratory infection. one nurse stated: "i'm not gonna, you know, make that mistake again." this was attributed to, in part, experiences that hcws had in which they had initially worn droplet protection, only to learn that the patient was later diagnosed with an airborne infection, which would require a higher level of rpe. clinical experience has been shown to improve adherence, yet it may also spur overuse. in our data, when hcws did not trust the working diagnosis they relied on their own clinical judgement, which led them to use a higher level of rpe protection than the protocols specified. this behavior can result in variable rpe use owing to the different levels of experience across staff. further, inappropriate overuse may desensitize people to the importance and value of rpe, and send a confusing, and potentially alarming, message to others. overuse of rpe may also result in equipment being unavailable when needed, as we and others have found. moreover, availability is an important factor in adherence. when hcws do not trust the diagnosis, huddles could help team members communicate about risks, address potential concerns, and lead to consistent and appropriate rpe use. team huddles are a proven management and communication approach that could be used to review emerging patient diagnostic data and discuss with team members how to best use rpe for the unique situation. this deliberate review and clarification of risk levels may lead to hcws' increased trust in infection control systems and belief that the hospital is motivated not by finances, but instead hcw safety. a second problem area was the perception of heightened risk and the related feeling of inadequate rpe availability. some hcws believed that their site had many high-risk patients, particularly those in larger facilities in dense urban areas. in contrast, hcws at sites that reported that there were few high-risk patients, described plentiful, accessible equipment. other hcws reported the hospital not having their specified mask size or that rpes were locked away, leading study participants to speculate that the hospital was trying to save money by limiting access to n use to discourage inappropriate use. prior research has documented that hcws in larger, more urban hospitals are at greater risk of respiratory infections, especially during outbreaks. the relationship between site type and risk of infections may be further complicated by risk perceptions. the third problem we found related to the unique circumstances in eds. patients coming into the ed arrive without a diagnosis, which puts hcws at greater risk of exposure to infectious agents. yet, perplexingly, this seems to have desensitized these hcws. some hcws reported that even after an ed patient had received a diagnosis warranting use of rpe, ed staff might continue to forgo rpe, because, as one hcw noted, the staff believed they had "already been exposed." hcws working in the ed may perceive that exposure risks are omnipresent, with rpe being unable to protect from the myriad of potential exposures. this is problematic because these hcws may habituate to not wearing rpe when protocol requires use. other research has shown lower adherence to personal protective equipment, including n s, among hcws in eds. our findings were consistent with several domains in the health belief model. for example, we found that hcw's desire to wear rpe may increase in the presence of symptomatic, but undiagnosed, patients, a feature of perceived susceptibility. rpe use was also informed by perceptions of the seriousness of patient symptoms or disease. additionally, the health belief model may provide guidance for strengthening safety systems, such as providing cues to action (eg, signs, carts) to help initiate donning rpe. however, whereas the health belief model was useful in developing the focus group guide, and used to guide parts of the analysis, it had limitations; our additional use of an inductive analytic approach was useful where the health belief model was lacking. for example, we encountered stories around rpe availability or rapidly developing emergent situations that may have precluded hcws' abilities to adequately process the severity and susceptibility. the health belief model was originally developed with the individual in mind to understand what influenced their likelihood of getting vaccinated. this origin helps explain why it was limited for explaining hcw behavior because hcws are enmeshed in complexities of health care facilities and systems. workplace culture, training, resource constraints, and clinical experiences create a multilayered work context above and beyond the individual perceptions of risk, susceptibility, and threat. our study has limitations. it was conducted at hospitals in regions of the united states, and not designed to determine differences among settings or differences by unit. findings related to the unique context of the ed were emergent and not part of our original study design, thus, more work needs to be done to understand ed microculture. study participants were limited to rns and nas; other clinicians, staff, and patient and family perspectives were not represented. the timing of our study was unique given the ebola outbreak and therefore increased sensitivity to rpe use. therefore, we may have heard greater concerns about rpe availability and use. moreover, our data collection method (focus groups) may have led to social desirability biases, with reluctance to report nonadherence. recent ebola and sars outbreaks remind us that a large-scale pandemic is always possible. adherence to respiratory precautions may become critical with little advanced notice. although government and public health agencies should continue to develop data-driven protocols, hospitals need to assess their own unique context, including local norms, particularly in the ed where patients arrive without a diagnosis or hcws may not fully trust the protocols for rpe use. our data provide insight into reasons for rpe nonadherence; importantly, these are to a large extent modifiable. early appraisal of facility-level-or ward-level in the case of the ed-vulnerabilities in patient safety culture surrounding rpe use could be a useful strategy for ensuring improved adherence during high incidence respiratory illness seasons when rpe use is critical. supplementary material associated with this article can be found in the online version at https://doi.org/ . /j.ajic. . . . behind the mask: determinants of nurse's adherence to facial protective equipment sars among critical care nurses appraisal of recommended respiratory infection control practices in primary care and emergency department settings development and initial validation of the respirator comfort, wearing experience, and function instrument health care workers' reported discomfort while wearing filtering face-piece respirators discomfort and exertion associated with prolonged wear of respiratory protection in a health care setting respirator tolerance in health care workers canadian agency for drugs and technologies rapid response reports. wear compliance and donning/doffing of respiratory protection for bioaerosols or infectious agents: a review of the effectiveness, safety, and guidelines. ottawa on: canadian agency for drugs and technologies in health influenza vaccination in healthcare workers: a comprehensive critical appraisal of the literature perceived risk of tuberculosis infection among healthcare workers in swaziland health belief model health behavior and health education: theory, research, and practice social learning theory and the health belief model the use of facemasks to prevent respiratory infection: a literature review in the context of the health belief model family physicians' experiences, behaviour, and use of personal protection equipment during the sars outbreak in singapore: do they fit the becker health belief model? factors influencing nurses' compliance with standard precautions in order to avoid occupational exposure to microorganisms: a focus group study the narrative structure as a way to gain insight into peoples' experiences: one methodological approach working experiences of nurses during the middle east respiratory syndrome outbreak current practices and barriers to the use of facemasks and respirators among hospital-based health care workers in vietnam a multilevel neo-institutional analysis of infection prevention and control in english hospitals: coerced safety culture change? mistake-proofing healthcare: why stopping processes may be a good start patient safety: a literative review on the impact of nursing empowerment, leadership and collaboration impact of the influenza a (h n ) pandemic on canadian health care workers: a survey on vaccination, illness, absenteeism, and personal protective equipment communication huddles: the secret of team success huddle up! the adoption and use of structured team communication for va medical home implementation emergency department response to sars behavioral science at the crossroads in public health: extending horizons, envisioning the future key: cord- -my wj uu authors: sheridan rains, luke; johnson, sonia; barnett, phoebe; steare, thomas; needle, justin j.; carr, sarah; lever taylor, billie; bentivegna, francesca; edbrooke-childs, julian; scott, hannah rachel; rees, jessica; shah, prisha; lomani, jo; chipp, beverley; barber, nick; dedat, zainab; oram, sian; morant, nicola; simpson, alan title: early impacts of the covid- pandemic on mental health care and on people with mental health conditions: framework synthesis of international experiences and responses date: - - journal: soc psychiatry psychiatr epidemiol doi: . /s - - - sha: doc_id: cord_uid: my wj uu purpose: the covid- pandemic has many potential impacts on people with mental health conditions and on mental health care, including direct consequences of infection, effects of infection control measures and subsequent societal changes. we aimed to map early impacts of the pandemic on people with pre-existing mental health conditions and services they use, and to identify individual and service-level strategies adopted to manage these. methods: we searched for relevant material in the public domain published before april , including papers in scientific and professional journals, published first person accounts, media articles, and publications by governments, charities and professional associations. search languages were english, french, german, italian, spanish, and mandarin chinese. relevant content was retrieved and summarised via a rapid qualitative framework synthesis approach. results: we found eligible sources from countries. most documented observations and experiences rather than reporting research data. we found many reports of deteriorations in symptoms, and of impacts of loneliness and social isolation and of lack of access to services and resources, but sometimes also of resilience, effective self-management and peer support. immediate service challenges related to controlling infection, especially in inpatient and residential settings, and establishing remote working, especially in the community. we summarise reports of swiftly implemented adaptations and innovations, but also of pressing ethical challenges and concerns for the future. conclusion: our analysis captures the range of stakeholder perspectives and experiences publicly reported in the early stages of the covid- pandemic in several countries. we identify potential foci for service planning and research. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. they may be disproportionately negatively affected because the area already more likely to be experiencing social isolation and exclusion, stigma, and financial, employment and housing difficulties [ , ] . potential short-term impacts on people with pre-existing mental health conditions include: • effects of being infected with covid- , including any psychiatric sequelae, potentially increased risk of being infected or of severe covid- among some groups of people with mental health conditions, and concerns regarding equitable provision of physical healthcare. • effects on people with mental health problems resulting from infection control measures, including potential impacts of social isolation, and lack of access to usual supports, activities and community resources [ ] . • challenges associated with infection control in group settings, especially in hospitals and residential settings. • the effects of reduced or re-configured mental health care delivery. various adaptations and innovations to enable mental health services to respond to new requirements have been discussed, including infection control strategies on mental health service premises, and remote working [ , ] . while a number of position papers have been published, there has been relatively little systematic documentation of the impacts of the pandemic on people already living with mental health problems and on mental health care, and of strategies to mitigate these. these have been identified as urgent priority research areas [ , ] . we aim to begin addressing this by searching for and summarising relevant material in the public domain early in the pandemic, including accounts published by people with relevant lived experience, practitioners, mental health organisations and policy makers, and also by journalists who have investigated experiences and perspectives of service users, carers and service providers. our aim was to conduct a document analysis to create an initial mapping and synthesis of reports, from a number of perspectives, on the early impacts of and responses to the covid- pandemic on mental health care and people with mental health conditions. we drew on published sources of all types and included several languages used in countries in which the impact of the pandemic has been severe. we conducted a framework synthesis to summarise themes from sources reporting narratives and experiences of the impact of the pandemic and describing responses to it at both individual and service levels. we had planned, if warranted, also to conduct a narrative synthesis of any scientific data retrieved in our search: there was little as yet (table a) : this paper, therefore, primarily reports on our analysis of a wide range of documents in the public domain through a rapid qualitative framework synthesis method. specifically, we sought to analyse reports regarding: • direct impacts of covid- , subsequent public health measures and sudden social changes on people with preexisting mental health conditions and their families; • self-help and informal help strategies utilised by service users and carers; • challenges faced by mental health services during the pandemic; • innovations and adaptations to mitigate impacts of covid- on mental health services, and reports regarding their effectiveness. rapid syntheses are recommended by the world health organization as an appropriate and timely method in rapidly developing situations [ ] , quickly providing actionable evidence that can help inform health system responses. our protocol was prospectively registered on prospero (crd ). we took a multi-faceted approach to scope a broad, rapidly updating literature base and identify reports, articles and media from a wide range of perspectives and countries. the following database and 'grey' literature searches were conducted: the detailed terms used for database and web searches appear at the end of the supplementary report (supplementary report, section ). we included items meeting the following criteria: • population mental health services, people using any mental health services or who have mental health difficulties that appear to pre-date the pandemic, or mental health service staff. • phenomenon covid- . • focus relevant to at least one of the topics above, focusing on people already living with mental health conditions at the onset of the pandemic, or on mental health care. • source type published paper, article, blog post commentary, online media (including videos and podcasts), relevant to the research questions. social media were excluded, as were blogs and articles not published via a public media channel or on the website of a public body or charity. • date january -april . • language publications in english, french, spanish, german, italian or mandarin chinese. we selected these languages as we were able to involve native speakers and anticipated a substantial relevant literature. we excluded items focusing mainly on learning disability, autism or dementia, unless combined with comorbid mental health problems, and those mainly discussing staff wellbeing. queries were raised with the wider research team and discussed until consensus was reached. a senior reviewer (sj) checked a subset of articles to validate inclusion decisions. for each included item, title, author, website address, access date, source type (e.g. journal article, news report, video, guidance, etc.), country, setting, service user group, and author background(s) were extracted. framework-based synthesis was used to enable a systematic and structured approach to rapidly summarising and analysing a large dataset [ , ] . analysis comprised the following steps: three researchers (sj, lsr and ts) familiarised themselves with relevant materials of various types, and then developed an initial analytic framework, comprising questions related to our study topics. we developed a semi-structured data collection form using qualtrics software (qualtrics, provo, ut) to capture data from each article (supplementary report, section ). eight researchers piloted the form with five articles, and the framework was adjusted and finalised based on their coding and feedback. "other" and "research reflections" categories were included to allow capture of material not covered by the initial framework. included materials from the search were indexed and charted using the online form. to conduct this work rapidly in all included languages, a large number of researchers (n = ) were involved, most postgraduates, research staff or lived experience researchers linked to university college london or king's college london. examples of well-coded articles were provided, and the first articles coded were checked (by lsr, blt, and ts) to ensure consistency, with further training for individual researchers provided as necessary. these data were then imported into microsoft excel to create the framework matrix for mapping and interpretation. twelve researchers experienced in qualitative analysis (sj, ts, lsr, pb, jn, blt, fb, jec, hs, jr, ps, and sc) mapped, interpreted, and summarised the data. initially, a thematic framework was developed through discussion among them and with senior study researchers. each researcher was assigned a portion of the data (normally one or more themes) and asked to summarise all data in the framework matrix relevant to that theme into narrative and tabular summaries. they returned to original sources if summaries were unclear or very limited. these were then discussed, further synthesised and combined to produce the results below and in the supplementary report (section ). we found relevant sources, including articles from the published literature databases, from web searches focused on relevant organisations, and from search engines: sources are listed in the linked mendeley repository [ ] . non-english language articles were identified through translated searches. further articles were identified through expert recommendation and tweets. included articles were english (n = ), chinese (n = ), french (n = ), german (n = ), italian (n = ) and spanish (n = ). table summarises included article characteristics. detailed summaries for each theme are in our supplementary report (section ): here we provide an overview. we focus first on reports regarding impacts of the pandemic on people living with mental health problems and individual strategies for coping, then on impacts on the mental health care system and adaptations and innovations put in place. similar themes appeared to emerge across countries and types of source, so all are reported together. any peerreviewed papers reporting data are identified below; position papers, editorials and other work describing perspectives and experiences of scientists rather than data are synthesised along with other sources. most sources on this topic gave narratives and personal observations regarding deteriorating mental health (supplementary report, table ), but a handful of surveys had been conducted among people with mental health conditions (supplementary report, table a ). a survey of young people with mental health needs, and two surveys of adults with mental health problems, all carried out for uk mental health charities, found that around four out of five respondents described experiencing increased mental health difficulties following the onset of the pandemic [ ] [ ] [ ] . the survey of young people reported high levels of anxiety and impulses to self-harm in the week in which schools closed in england. a report from a survey focused on financial impacts elicited self-reports of poorer wellbeing in adults with mental illness being linked to current financial and employment concerns [ ] . a further survey carried out by an academic organisation and a charity again elicited many self-reports of worsened mental health very early in the pandemic [ ] . a usa research study in pre-print showed self-reports of worse mental health in the majority of adults with mental illnesses, with only approximately one in ten feeling that they were coping well with the situation [ ] . in a small published chinese study, hao and colleagues found that service users were experiencing more severe mental health symptoms than the general population at the peak of the crisis in china [ ] . we found no longitudinal surveys, and only the small chinese study included a control group. many sources reported observations from clinicians or self-reports of negative impacts on pre-existing mental health conditions. mechanisms suggested for this included increased anxiety and fear of illness and death directly related to covid- ; impacts of "lockdowns" and social distancing policies, especially of isolation; interactions between symptoms of mental health problems and current public events and concerns; impacts of loss of support from health and other services; and effects of increased social adversities, such as domestic abuse, family conflict or loss of employment. some accounts described impacts on specific mental health conditions, while others simply described an overall negative impact. some conditions have been the focus of numerous and detailed narratives. among people with depression and anxiety, sudden loss of the routines and activities that help people keep well, loneliness and isolation, and increases in health anxiety related to covid- are recurrently identified as exacerbating factors. many articles on obsessive compulsive disorder (ocd) described struggles with requirements for hygiene that contradict usual strategies for managing ocd and intensification of obsessional thoughts about contamination or infection. regarding people with eating disorders, we found many reports that loss of eating and social routines, disrupted access to food and the increased societal prominence of food seem to exacerbate some people's symptoms. one survey of service users with eating disorders found that % reported worsening of symptoms during the first weeks of lockdown in spain [ ] . negative impacts on mental health conditions were described alongside resilience in adversity and even some positive experiences of the pandemic period (see below). several scientific and media articles predicted a rise in suicide. however, an international collaboration of suicide experts argued this should not be accepted as an inevitability, but mitigated through urgent development of suicide prevention strategies [ ] . a few sources also described exacerbation of mental health problems as people replace usual coping strategies with more problematic ones, such as alcohol and substance use or gambling. the pandemic has resulted in extensive and sudden social changes and new risks, some with particular relevance to people living with mental health problems. we mapped the following themes: many sources described loneliness, social isolation and loss of usual activities, and the negative impacts of these on mental health. many people with mental health problems rely on the stability of routines and social contacts to manage their mental health condition, feel connected, and detect signs of deterioration. loneliness was described as arising both from general restrictions on activities and contacts, and from sudden closure of services, including therapeutic sessions and groups, which had been sources of highly valued contacts. patients in inpatient settings have been particularly affected by suspension of visits and leave, sometimes leading to extreme isolation and loneliness, especially when compounded by requirements to stay in hospital rooms and cancellation of ward activities. negative impacts from closure or restriction of a range of services were frequently discussed (see also below for discussion regarding service-level changes). some individuals reported abrupt termination or interruption of their treatment, or the replacement of face-to-face appointments by brief check-in phone calls. others reported being unable to access care for new difficulties, or the postponement of periods of psychological therapy that were about to begin. some sources described feeling abandoned, with a lack of access to information about how to seek urgent help if needed or about when care might resume. remote care was not always seen as sufficient, due to lack of access to or ability to use technology, lack of privacy to engage in remote appointments, and more superficial therapeutic contacts. interruption to medication access and adherence was also reported by several sources, including disruptions to supply or to in-person contacts required to prescribe, monitor side effects and toxicity, and administer medication. some sources reported deterioration in mental health in the context of cessation of medication or lack of monitoring or care. a common theme was that "we are not all in this together", with covid- risks magnifying existing inequalities and creating new ones [ ] . thus covid- and accompanying restrictions were seen by some sources as disproportionately affecting those already experiencing health and social inequalities, through economic impacts, the greater hardships of social restrictions in poor living circumstances, and the withdrawal or restriction of services disproportionately relied on by more deprived populations. withdrawal or reduction of services has been described as resulting in substantially more pressure for families and carers to support service users and manage distress and behavioural difficulties. some families with caring responsibilities have reported feeling abandoned by services, especially in the context of the stresses and greater isolation associated with the "lockdown". meanwhile, some service user accounts expressed worry about 'burdening' relatives by relying on them during the lockdown, or about risks of infecting relatives with covid- , particularly those at greater risk of severe illness. there were also some positive descriptions of enhanced relationships with family and friends during this period, especially by keeping in touch more online or by phone, and some had moved in with family and become closer as a result. a widely expressed concern regarding families shut in together related to the risk of increased conflict, aggression, and violence between household members and especially towards children: many sources expressed concern about this, while a smaller number described relevant incidents. concerns related to people with mental health problems both as victims and as perpetrators. the advice to "stay home" is challenging when home is not a safe space. both current household circumstances and reduced access to police, social services, schools and courts are identified as risk factors for continuing conflict and abuse. seeking help may be difficult if abusers are in constant proximity. sources argued that systems of care and outreach need to be provided for at-risk populations, potentially including communication of these via social media. we did not find sources on the extent of covid- infection among people with mental health problems, or whether rates of infection, or of severe consequences of infection, differ from the general population, nor were there many individual narratives regarding the experience of covid- infection among people with mental health problems. there were some accounts of outbreaks of infection in hospital and residential settings and of service problems that might contribute to these, for example in the usa, china and italy (see below regarding inpatient service challenges). many authors noted that co-morbidity between mental and physical health problems, and lifestyle factors (drug and alcohol use, obesity or, in the case of eating disorders, malnutrition), may result in potentially greater risk of infection and of severe consequences of infection. particular concerns were raised regarding people living in poor housing and confined, crowded, or chaotic environments, such as prisons, inpatient or residential settings, or the homeless mentally ill, as hygiene, infection control, and physical distancing practices are likely to be especially challenging. some reports relate to people with mental health problems experiencing "dual stigma" in terms of additional barriers to accessing physical healthcare: concerns related to quality of treatment for covid- infection in psychiatric hospitals are discussed below. while negative reports exceeded them, some positive aspects of life during the pandemic were described in first person accounts, and via clinicians. some people drew comfort from feeling that everyone was "in the same boat": that people were experiencing a "shared trauma" or that the rest of society was now experiencing similar challenges to the ones they faced day-to-day, such as social isolation or anxiety, and so have greater empathy. feelings of decreased marginalisation, greater acceptance by wider society, and increased levels of community and solidarity were reported. for others, the focus on the pandemic distracted them from their pre-existing conditions, with some reporting fewer symptoms. second, some described being able to mobilise existing reserves of resilience and coping skills during the pandemic, sometimes resulting in an increased confidence. finally, there were many reports of people taking advantage of innovations in remote and digital support and the increasingly widespread use of video calls for communication, support and social contact. these were particularly valued by people for whom difficulties such as physical mobility, social anxiety or paranoia impede face-to-face contacts. many publications describe strategies that people with preexisting mental health conditions have used to manage their mental health and social stresses during the pandemic. a pressing need for many has been to try to replace the activities, routines and contacts that usually support self-management. reported self-management strategies in the pandemic have included engaging in purposeful, creative or relaxing activities, such as cooking or painting, or keeping journals to record worries or positive experiences. use of therapeutic and self-help techniques, such as mindfulness, exposure therapy or meditation, was widely reported, though some found these of limited usefulness given current challenges. others have sometimes found helpful self-management tools and resources, including helplines, online therapy services, websites, podcasts and apps. the importance of maintaining a positive attitude, of selfacceptance and of not putting oneself under pressure was widely expressed. looking after one's physical health, such as taking regular exercise and healthy eating, maintaining a daily routine, and keeping in contact with trusted friends and family members, was emphasised in many sources. a number of people, particularly those with anxiety, reported attempting to avoid or substantially reduce their consumption of potentially stressful or triggering media coverage of the pandemic, relying instead on official or other trusted sources. several sources described types and impacts of practical and emotional support among peers. this included mutual support and practical help, such as collecting medication. sharing experiences and stories of mental health management, coping strategies and positive adaptations featured. digital and online approaches to delivering support had been proactively and creatively deployed in some peer networks to facilitate one-to-one, group and community connections and activities (including recreation and socialising). communicating and connecting were considered vital for reducing social isolation in lockdown, managing mental health, and maintaining relationships with friends, family and peer support networks. the importance of connecting with others in inpatient settings during the pandemic was also mentioned. mutual aid among peers appeared to have positive wellbeing benefits for those offering support. table ) reports based on official data were not generally available at this early stage, but several sources included reports from service managers and clinicians regarding service activity. most reported reduced referrals and presentations to community mental health services, emergency departments and psychiatric wards in the early phases of the pandemic, though one italian source described a subsequent rise. potential explanations included service users' fears of infection, beliefs that help would not be available, or wishes not to burden services. meanwhile, large increases were reported in several countries in use of relevant helplines and, in the usa, a rise in prescriptions for mental health medication. in inpatient settings and supported housing where people live together, immediate concerns were with preventing the spread of infection while attempting to maintain a therapeutic environment. regarding immediate infection control, clinicians' reports from several countries described a lack of protective equipment, an inability or unwillingness of some patients to adhere to protocols, and difficulties with distancing due to ward and office layouts. lack of realistic guidance specific to mental health settings was recurrently reported. lack of expertise or facilities to treat people with covid- effectively was identified as a challenge in providing equitable care, especially where pressure was reported to treat people with mental health problems and covid- as far as possible within psychiatric hospitals. a tension was frequently reported between providing good quality mental health care and infection control, with many inpatients confined to their rooms much of the time with limited face-to-face contacts and little access to advocacy, group-based therapeutic activity or trips into the community. the most frequently reported inpatient adaptation to meet these challenges was the creation of covid- specific units for psychiatric patients with confirmed or suspected illness, often with support from physical health care professionals and protocols in place for transfer to intensive care if needed. other infection control measures included quarantine following admission, early discharge and initiatives to reduce admissions, staggered mealtimes and reduced use of communal spaces. an innovation described by several sources was enhanced use of technology to enable remote contact with healthcare professionals for therapy during hospital admissions, and with families to maintain social contact. in some settings, depending on current national restrictions, group therapy sessions and external visits were maintained with use of personal protective equipment (ppe) and physical distancing protocols. although supported housing settings face some similar challenges to inpatient units, we found few reports about these. the predominant challenges reported in community settings were the need to reduce face-to-face contact and to cope with reduced capacity due to staff absence, diversion of resources to covid- wards, and reduced community resources in general. settings where service users mingle (e.g. day services) tended to have closed, and in some regions, for example of spain and italy, all but urgent response appeared to have closed at the onset of the pandemic, diverting resources to physical healthcare. however, a more usual response around the world appears to have been maintaining community service provision, but with much more restricted face-to-face contact. for the face-to-face working that has continued, poor access to ppe and lack of clear infection control procedures featured in reports from community mental health settings in several countries. telehealth tools appear to have been rapidly implemented in community mental health services across the globe, allowing care to continue at least to some extent. video calls are used both for staff meetings and patient contacts, with some innovative use for group and activity programmes. the use of digital tools such as apps and websites for therapy appears to have also increased, but was less discussed. this shift to telemedicine appears to be welcomed for use in some contexts by many clinicians and service users, who expect this to outlast the pandemic. however, important impediments and limitations were that some service users lacked technological access and expertise, or privacy for calls; poor technology resources in services; and potential negative impacts on rapport and therapeutic relationships. the voices of the digitally excluded are particularly likely to remain unheard. several challenges were identified in maintaining professional values and human rights during the pandemic. these especially-although not exclusively-centred on inpatient psychiatric settings. some sources, especially from france, argued that access to physical health care (for covid- ) is inequitable for mental health service users, and that they may receive poorer quality health care, due to stigma and to a policy of treating them as far as possible in psychiatric units rather than general hospitals. there were also concerns that mental health care may become less ethical during the pandemic, with clinicians and service users in various countries reporting beliefs that medication doses and the use of sedation have increased, or that coercive and restrictive practices which impact rights and freedoms may be rising, especially in wards with compromised therapeutic environments and access to advocates. though they have not as yet been put into practice, the provisions in the emergency coronavirus act in england and wales were reported to have caused great concern by potentially allowing involuntary admission decisions to involve fewer healthcare professionals, extending time limits on detention and facilitating the use of treatment without consent. reduced access to legal representation and advocacy was also reported. the final theme concerned fears and expectations about the future. internationally, a delayed wave of increased need for services was widely anticipated, potentially combined with reduced resources to meet this, especially where services are already underfunded. the potential long duration and fluctuating nature of the pandemic was also a concern: coping strategies may not be sustained at individual or service levels. we summarise here the first reports regarding the impact of the covid- pandemic from a wide variety of sources, mapping the impacts, concerns, experiences and responses at an early stage from a variety of perspectives and locations, focusing on recurrent themes. reports suggest that individuals with mental health problems have much to cope with: pandemic fears and circumstances interact with some symptoms; routines, contacts and activities that people have developed to manage their mental health have been shattered; and loneliness and social isolation are more prevalent. the risk that social adversities and existing inequalities may get worse is very concerning. while the current situation is new, these reports are congruent with findings of persisting negative psychological and socio-economic impacts arising from previous epidemics [ , , ] . however, the narratives we examined also caution against making assumptions about impacts, as responses to the pandemic clearly vary. many people with mental health problems are unfortunately used to isolation and adversity: this may result in resilience and abilities to manage challenges actively and to draw on peer and community support. initiatives that support them in this are potentially valuable. regarding service impacts, the immediate wave of increased activity predicted by some seems not to have occurred in the early weeks of the pandemic, or to have shifted to services such as helplines. however, a later surge of activity is widely expected. currently, some of the most pressing concerns relate to inpatient and residential care settings. in these environments, there are both specific and immediate challenges regarding infection control, with severe potential consequences for failure, and a pressing need to combine infection control with maintaining a therapeutic environment, safeguarding patient rights, and avoiding isolation in hospital. rapid research to investigate and compare strategies to address these challenges would be valuable. in the community, reports of telehealth having been swiftly adopted are striking given that implementation of innovations in health services is often observed to be slow [ ] : both clinician and service user responses suggest it may well endure after the pandemic. adoption of telehealth has previously been slow in many countries, despite evidence that it can be an effective, cost-effective and acceptable approach to reducing treatment gaps and improving access to mental health care for service users, especially where access is otherwise limited [ ] [ ] [ ] . we suggest that an urgent task now is to further co-produce, test and implement promising telepsychiatry initiatives so that they are as effective and acceptable as possible, drawing on already available guidance and evidence. [ ] . barriers need to be addressed, the most appropriate technologies identified, and both staff and service users supported in their use. meanwhile, the limitations of these technologies and the need to be selective in their use also need to be recognised, especially where continuing use following the pandemic is contemplated. a range of legal, regulatory, organisational and cultural challenges will also need to be addressed [ , ] . our search was wide ranging, achieving our aim of capturing many perspectives from many types of source and country: however, it will not have been comprehensive. we have compressed a large amount of material into a small space to ensure that it is useful (our supplementary report provides much more detail). although we encompass multiple countries and languages, our scope is not global, and most notably includes few reports from low-or middle-income countries. many of the sources were identified using web search engines. search results from these are influenced by factors such as time of day and ip address, limiting replicability and comprehensiveness. our english search strategy was more extensive than for other languages, especially because english-speaking experts contributed additional sources. people with experience of using mental health services and mental health clinicians were involved in many ways with this research, but day-to-day management was mainly by academic researchers not currently using or working in services. we adopted a rapid qualitative process for coding and summarising the data [ ] , not including substantial double coding: experienced researchers checked each coder's first summaries, and during the summarising process, we returned to sources where there was inconsistency or lack of clarity, but it is likely that ideas and themes were missed. our process was primarily deductive and based on a positivist paradigm, although discussions amongst team members with qualitative analysis experience, and use of narrative summaries, helped to retain the inductive spirit of qualitative analysis within a large and rapid analytic process. as yet, relevant scientific data are few. we have grouped together narratives and observations from all other types of sources on the basis that when scientists are reporting views, experiences and predictions rather than research findings, these are not necessarily more informative than the experiences of people trying to manage their own mental health problems or of clinicians trying to support them and to maintain services. journalists do not generally follow the same principles of objectivity as scientists, but in a rapidly evolving situation their investigations have the advantages of being quickly carried out and of often reporting on direct contacts with service users and/or clinicians. they may, however, tend to focus on more extreme situations, just as the people with lived experiences or clinicians who write about their experiences are unlikely to be representative. their swiftly written reports do, however, provide a rich and varied corpus of material through which we can understand the range of early experiences, responses, knowledge and practice among people with pre-existing conditions and in the services that they use. with this work, we have created an early map of impacts and responses from the covid- pandemic that identifies areas requiring service and policy response, and many potential areas for future investigation. we note, however, that the current crisis is evolving rapidly, and suggest that while some concerns are likely to be consistent, it will be essential to continue to review needs, challenges and the success of responses, as much is likely to change. this study assimilated international and grey literature written in several languages. despite the inclusion of a wide variety of sources, there is an absence of discrete minority group perspectives and sources focusing on the disproportionate impact of covid- on bame (black, asian and minority ethnic) groups in particular. the synthesis touches on the denial of liberties of people with mental health problems but research is yet to explore aspects of urgency and emotionality around this issue or the effects of this as a secondary response. deprivation of rights from a fear that people cannot adequately socially distance, reducing the number of clinicians required to admit people under the mental health act and inequalities of treatment for those with mental health problems who have covid is unacceptable and worthy of future scrutiny. safety relating to mental health environments was omitted. given the challenges of segregation without the unethical use of sedation and solitary confinement, attention should be directed towards ward design to minimise contagion. regarding people's ability to self-manage, it is unclear to what extent this can be framed as 'resilience' in circumstances with few other options, and what can be maintained without support. others may only opt to self-manage from fear of infection or concern about being burdensome to an overwhelmed nhs. reported satisfaction with virtual consultations naturally omits the voice of those unable to participate, and so conclusions should be viewed with caution. digital exclusion is real and complex. issues raised in the paper-a triple whammy of poorer service, loss of rights (both informal and state sanctioned e.g. coronavirus act) and the reduced access to advocacy or legal services also have an aggregate relationship. the complexity of this effect requires deeper qualitative research. going forward, it is vital to understand the long-term mental health consequences that pandemics have on different intersections of society. this is an independently written perspective from lived experience contributed by some of the co-authors with relevant experience. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/ . /. factors associated with mental health outcomes among health care workers exposed to coronavirus disease covid- : results of a national survey of united kingdom healthcare professionals' perceptions of current management strategy-a cross-sectional questionnaire 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long-term psychiatric morbidities among sars survivors review of key telepsychiatry outcomes the empirical evidence for telemedicine interventions in mental disorders a systematic review of the use of telepsychiatry in acute settings guidance on the introduction and use of video consultations during covid- : important lessons from qualitative research the use of telepsychiatry during covid- and beyond telepsychiatry and the coronavirus disease pandemic-current and future outcomes of the rapid virtualization of psychiatric care fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science rapid qualitative research methods during complex health emergencies: a systematic review of the literature luke sheridan rains · sonia johnson , · phoebe barnett · thomas steare · justin j. needle · sarah carr , · billie lever taylor · francesca bentivegna · julian edbrooke-childs · hannah rachel scott · jessica rees · prisha shah · jo lomani , · beverley chipp · nick barber · zainab dedat · sian oram · nicola morant · alan simpson , on behalf of the covid- mental health policy research unit group key: cord- -e jttmab authors: sharma, d.c.; pathak, dr abhishek; nath chaurasia, dr rameshwar; joshi, dr deepika; kumar singh, dr rajesh; nath mishra, dr vijay title: fighting infodemic: need for robust health journalism in india date: - - journal: diabetes metab syndr doi: . /j.dsx. . . sha: doc_id: cord_uid: e jttmab background and aims: communication plays an important role in advancing public health goals as well as in greater appreciation of underlying science and public policies. it is critical at all times, be it promoting health benefits of immunisation, importance of hand hygiene or taking personal measures for prevention of non-communicable diseases. communication assumes even greater importance in the time of emergencies like the ongoing covid- pandemic. a primary vehicle for health communication is mass media like television channels, newspapers and radio channels. methods: an analysis of current trends shows that the messages emerging from mass media are getting further amplified and dispersed through digital outlets and social media platforms which have become immensely popular. this has also given rise to a new phenomenon called infodemic or over-abundance of information – both genuine and fake. results: the article examines role of mass media in health communication in times of pandemic and the context of infodemic. conclusions: the analysis points to the need for improvement in health journalism to improve its quality, credibility as well as relevance in a country like india where mass media consumption is high and health literacy is low. mass media refers to tools and technologies deployed to communicate information and entertainment to the masses. media scholar wilbur schramm defined a mass medium as "essentially a working group organised around some device for circulating the same message, at about the same time, to large numbers of people." this implies mass media is mediated through a device or a medium which could be a newspaper, radio set, television screen or mobile phone or any other digital screen. the rise of social media platforms has added new dimension to the media landscape though social media can't be clubbed with media like newspapers and television because not all news, information and entertainment in the social media is created by journalists and there are no gatekeepers like editors. yet there are a lot of synergies between social media and mainstream or legacy media. the role of mass media is to inform and educate citizens about new developments in political, social, economic, scientific, health, and cultural spheres of the society. issues, subjects and themes that figure prominently in media become prominent in the public mind too. therefore, the coverage of health in mass media and its quality is very critical. mass media is a key source of health-related information for the general public. a survey done by the pew research center for the people and the press showed that attention to health news is ranked sixth in popularity among news topics. it is outranked only by news about weather, crime, community, the environment, and politics. besides being a source of health news and a medium to shape general understanding about health, experts have argued, mass media also help in promoting public health. , , media, according to wallack, "can be a delivery mechanism for getting the right information to the right people in the right way at the right time to promote personal change." that's why all health communication and disease prevention strategies emphasise on health messaging through mass media. studies have cautioned that "inadequate, misleading or incomplete news reporting constitutes a public health threat. such reporting can lead people to make misguided choices that may put their health at risk or influence policymakers to adopt inadequate or harmful laws, regulations, or policies." if media ignores a health issue, it may affect implementation of related public policies designed to have a positive impact on public health. a statement of principles published by the association of health care journalists states that "journalists have a special responsibility in covering health and medical news. association members know that readers and viewers may make important health care decisions based on the information provided in our stories." larger objective of all health communication is not just to inform but to motivate people to make informed choices and decisions about their health and overall quality of life. much of public understanding of health and health policy occurs not from their direct experience but through what they read and watch in media. health news informs people about disease and prevention, motivates them to change their behaviours and promotes understanding of health policy as well as public health. health journalists, thus, act as mediators between public and doctors, scientists and drug companies. in effect, health writers help in translating or transferring scientific knowledge about diseases and health to the society at large. therefore, both quantity and quality of health news appearing in mass medianewspapers, radio, television and internet -is important as it plays a critical role in health communication, which has a direct bearing on disease prevention, health promotion and quality of life. the quality of media coverage of health, in particular, has emerged as an area of concern in recent years in india. for instance, a study of obesity-related news stories in six indian newspapers by the national institute of nutrition, hyderabad, found most obesity-related coverage to be sensational. some of the articles on obesity were identified as selfcontradictory. in several reports, the source of information was not mentioned, while in nearly all stories journalists "ignored methodology of the research and rarely discussed design flaws." a study of coverage of h n outbreak in times of india showed that the newspaper framed h n as a deadly disease and its coverage presented death in such a manner as to produce fear and panic. by choosing not to provide contextual informationpercentage of dead or recovery cases, the newspaper framed h n virus into a 'deadly disease' and created an exaggerated sense of uncertainty, anxiety and fear. in contrast, a study in the uk found that newspaper coverage of the swine flu epidemic in - was "largely measured" unlike the trend of overhyping the flu pandemic in media elsewhere in the world. while overload of information is a dominating feature of the information age, the covod- pandemic has given rise to a new phenomenon called infodemic. the world health organisation (who) has described it as "second disease" accompanying the pandemic. the world body has defined 'infodemic' as 'an over-abundance of information -some accurate and some not -that makes it hard for people to find trustworthy sources and reliable guidance when they need it.' false information in circulation can be classified as both disinformation (designed with malicious intentions) and misinformation (lies spread with or without bad intentions). in the both the cases, it is harmful to its consumers as the information in question relates to human health. who has also launched an international programme on infodemiology, just like epidemiology of any other disease. it feels that infodemic -its causes, spread, risk factors, prevalence-need attention and focus similar to diseases if solutions or treatment for it has to be found. another un agency, unseco, in its policy briefs on infodemic has observed that "the volume and velocity of false information within the 'infodemic' points to the existence of a toxic disinfodemic of disinformation and misinformation." it says "while information empowers, the disinfodemic disempowers. it endangers lives and leads to confusion and discord.' in addition to the existing challenges of increasing space for health in media and enhancing its quality, the emergence of infodemic poses new challenges for health journalism practice in india. studies have shown that a bulk of the information that forms part of infodemic messages circulating on social media are coming from 'unreliable sources' and which are not originating from verified sources such as newspapers. data scientists are applying machine learning techniques to analyse infodemic messages. an analysis of million messages relating to the pandemic in languages, conducted by bruno kessler foundation, showed that percent of these messages came from unreliable sources. another study by the covid- infodemic observatory found that % tweets related to the pandemic were produced by bots and % of them were unreliable. as the volume and velocity of misinformation and disinformation message grows during a health crisis such as the current pandemic, the onus of clearing the air falls on the mainstream media. in addition to giving authentic news, mainstream media has to bust fake news which has risen sharply during the pandemic. the pandemic and the rise of infodemic have reinforced the role of professional health journalism. the need for verified and authentic information is the need of the hour, and this need can be fulfilled by health journalists through mainstream media. free and independent media can be an effective counter or antidote to toxicity of the infodemic. besides providing facts and verified news to people, independent media also holds governments and public authorities accountable. that's why trust of people in independent media like newspapers may be growing, despite difficulties being faced in circulation of physical copies. a study by the reuters institute found that % of respondents in six countries (argentina, germany, south korea, spain, the uk, and the us) said it was the news media that had helped them make sense of the pandemic. trust in news media was rated significantly higher than information received on social media. an online and offline survey done in india has revealed a majority of people have rejected myths and conspiracy theories floating around in social media, and have relied on scientific information. in order to strengthen indian media to play effectively its role of providing authentic and verified health news and information, the following measures are proposed: -employing professionally trained, fulltime reporters and subeditors to write and edit health stories. while health news is covered widely in indian media, much is left to be desired in its quality and relevance. this is because of lack of appropriately trained health journalists in indian newsrooms. for this to happen, there is a need for greater focus on health and science journalism in training schools, and also onthe-job training through workshops, fellowships etc. -newspapers and television channels will also have to undertake fact-checking functions, particularly to debunk fake news, misinformation and disinformation on health subjects. this needs to be done by professionally trained fact checkers equipped with skills in dealing with new digital platforms as well as editorial insights. many media houses in india have started doing this, but they need to focus more on health and science domains. there are independent fact checking organisations as well, and media houses can collaborate with them. -greater communication between media and health experts, researchers and policy makers is essential for improving quality of health news in indian media. for this, academic institutions, health bodies, and organisations engaged in scientific and medical research need to improve their communication with media keeping in view the need to explain research findings, policies and trends to media persons. experts from these bodies should also be available to offer expert comment to debunk fake news and misinformation. proactive measures are required from both media and health community. -one of tenets of good health journalism is to present evidence-based news along with benefits and risks of new therapies and research developments. findings of medical research come with a lot of caveats and disclaimers. research findings, therefore, have to be reported in media with proper perspective, and without giving rise to sensationalism or alarm. fear mongering should be avoided at all the times. health journalism training should lay special emphasis on this aspect. -it is also the responsibility of media to engage with people and communities, empowering them with 'news and information literacy.' this will help people to combat infodemic on their own, and reinforce faith of the people in media. such engagement with people is also critical to stimulate new solutions as well as their participation in health-related decisions and policies that affect them. as one of the four pillars of a democratic society, media has the responsibility to inform and educate people. newspapers, television channels and radio can play a pivotal role in shaping opinions of people and policy makers on key issues facing the society. the coverage of health in the press and its quality is very critical as this is a key source of health-related information for the general public. health news has the potential to promote public health, particularly when india is facing the triple challenge of communicable, non-communicable diseases and trauma. in the time of a health emergency like the covid- pandemic when a new phenomenon called infodemic has emerged, it is critical that health news delivered by newspapers is authentic, accurate and free from vested interests. therefore, it is important to take steps to improve the quantity and quality of health news in indian media. how communication works: in. w. schramm: process and effects of mass communication key news audiences now blend online and traditional sources the effectiveness of mass communication to change public behavior mass communication and public health: complexities and conflicts the sage handbook of media processes and effects the role of mass media in creating social capital: a new direction for public health checking the pulse: midwestern reporters' opinions on their ability to report health care news what are the roles and responsibilities of the media in disseminating health information? health communication and mass media: an integrated approach to policy and practice why health communication is important in public health a matter of looks: the framing of obesity in popular indian daily newspapers construction of death in h n news in the times of india uk newspapers' representations of the - outbreak of swine flu: one health scare not over-hyped by the media? new unesco policy briefs launched assessing the covid- 'disinfodemic navigating the 'infodemic': how people in six countries access and rate news and information about coronavirus. reuters institute scientific knowledge, perception and attitudinal changes during corona pandemic need for improving quality, credibility as well as relevance of health journalism in india capacity building of media persons, emphasis on fact checking can help boost quality the authors declare no conflict of interest associated with this paper. key: cord- - jkzbmsf authors: ying, wang; qian, yu; kun, zhu title: drugs supply and pharmaceutical care management practices at a designated hospital during the covid- epidemic date: - - journal: res social adm pharm doi: . /j.sapharm. . . sha: doc_id: cord_uid: jkzbmsf the coronavirus disease- (covid- ) is caused by the novel severe acute respiratory syndrome coronavirus that was first detected at the end of december . the epidemic has affected various regions of china in different degrees. as the situations evolve, the covid- had been confirmed in many countries, and made a assessment that it can be characterized as a pandemic by the world health organization on march , . drugs are the main treatment of covid- patients. pharmaceutical service offers drug safety ensurance for covid- patients. according to covid- prevention and control policy and requirements, combined with series of diagnosis and treatment plans, pharmacists in the first provincial-level covid- diagnosis and treatment unit in jilin province in northeast china have established the management practices of drug supply and pharmaceutical care from four aspects: personnel, drugs supply management, off-label drug use management and pharmaceutical care. during the outbreak, the pharmaceutical department of thju completed its assigned workload to ensure drug supply. so far, no nosocomial infections and medication errors have occurred, which has stabilized the mood of the staff and boosted the pharmacists' confidence in fighting the epidemic. for the treatment of covid- , pharmacists conducted adverse reaction monitoring and participated in the multidisciplinary consultation of covid- . up to now, the covid- patients admitted to thju have not shown any new serious adverse reactions and been cured finally. the hospital pharmacy department timely adjusted the work mode, and the formed management practices is a powerful guarantee for the prevention and control of the covid- epidemic. this paper summarized the details and practices of drug supply and pharmaceutical services management to provide experience for the people who involving in covid- prevention and contain in other abroad epidemic areas. an outbreak of coronavirus disease (covid- ) began in wuhan, hubei province, china in december . according to the prevention and control of infectious diseases law of p.r. china, covid- was classified as class b infectious disease, and measures had been taken according to the prevention and control standards of class a infectious disease. covid- was also managed in accordance with frontier health and quarantine law of p.r. china . the third hospital of jilin university (thju) is managed by china national health commission (cnhc) which is a large-scale grade iii-a hospital, with an annual outpatient service of about . million patients. the hospital was specified as the first provincial-level covid- diagnosis and treatment unit in jilin province. during covid- outbreak-period, the pressure of medical service has increased. efficient pharmaceutical practices could provide support for responding to the covid- pandemic. the pharmaceutical department of thju has carried out a series of work in terms of drug supply and pharmaceutical service, which has provided effective support for prevention, control and treatments of covid- . as of march , , the mortality rate of patients with covid- in thju was %, the number of infected medical staff was nil. the epidemic attracted the attention of the international communities and was declared the coronavirus a global pandemic by the world health organization (who) on march , . as of april , , a total of confirmed cases had been reported in countries outside china, including deaths. it is necessary to share practices and experience about epidemic prevention and control. this paper summarized the practices of preventing and controlling covid- in the pharmacy department of thju to provide reference for those who are facing the same situation. in the global fight against the outbreak of covid- , countries(areas) are facing with medical staff management challenges :( )insufficient medical staff, ( )physical and mental health,( )limited covid - prevention and control training. ( ) emergency human resource mechanisms could ensure work quality and improve management efficiency. the department of pharmacy have developed a pharmaceutical personnel echelons system to guarantee sufficient personnel resource. the first team was composed of pharmacists with experiences in fighting against sars, floods, earthquakes and other emergencies. the second team consisted of clinical pharmacists and laboratory pharmacists who had been responsible for drug supply and dispensing. the first team members were charged with the key responsibilities of advising and educating patients, maintaining a stable supply of pharmaceuticals, and guide suspected cases to fever clinic for screening as required. the second team members received epidemic prevention and control training, under the leadership of the first team members to carry out the work. otherwise, the pharmaceutical department have selected pharmacists with rich working experience and strong professional abilities as candidates of wuhan medical team. ( ) physical and mental health the covid- outbroke during the spring festival---the chinese traditional festival. many pharmacists travelled and returned hometown at that time. the pharmacy department designated a pharmacist to take charge of focusing on the staffs' health status. pharmacists initiatively reported their status every day, including travelled destinations, transportations, temperature, cough symptoms. if anyone came back from suspected epidemic areas was recommended to stay at home days for observation. during an epidemic, false information and rumors can generate serious negative effects to staffs' mental health, similar to the community prevention and control grid member measures , pharmacy department appointed grid emotion managers. each grid member was responsible for providing emotional management advice and help them: a. understand covid- correctly; b. accept the reality of the epidemic; c. encourage the expression of emotions, guide pharmacists through reading, listening to music, sports and other ways to transfer emotions, to overcome depression, anxiety, insomnia, and distress. ( ) carrying out training. the training mode was mainly online learning, the contents included three aspects: a. hospital isolation rules training, including: transfer routes, transfer vehicles and dedicated elevators for covid- patients, as well as related medical waste signs. drugs, patients and pharmacists should move along the designated routes, which help to reduce the risk of nosocomial infection and ensure the supply of drugs. b. prevention training. pharmacists must learn how to protect themselves from getting infected. a systematic nosocomial infection prevention and control training have been provided for pharmacists, such as process of use and destruct hats, masks, protective clothing correctly. c. covid- diagnosis and treatment plans training. from january to now, the covid- diagnosis and treatment plans have been updated seven times and several diagnosis and treatment plans webinars have been organized. through the training, pharmacists can master the isolation system, personal safety protection operation and latest treatment plans. scientific human resource mechanisms, adequate personal protection and timely training can help employees stabilize the mood and enhance confidence in fighting against the epidemic. by implementing the man-management guarantee practice, the pharmacology department of thju has resolve the problem of insufficient medical staff, ensuring the physical and mental health of pharmacists and deepen understanding covid - prevention and control plans. during the pandemic, drugs may be in late delivery and short supply due to logistics interruption and production disruptions for various reasons. otherwise, safe environment is an important guarantee for normal drug supply. to conquer these problems the pharmacy department have carried out four practices:( )establishing drug supply schemes based on treatment guidelines, ( )implementing online drug procurement,( )managing donated medicine,( )managing environment. ( ) pharmacists have made a list of covid- therapeutic drugs (table ) to establish covid- prevention and control drug supply schemes based on diagnosis and treatment plans, and the drugs on the list have been procured at first time. list of thju covid- treatment drugs [ ] [ ] [ ] type of treatment drug name interferon α - b injection, lopinavir / ritonavir, arbidol, ribavirin, paramavir, oseltamivir additionally, wechat® (the largest social communication mobile platform in china) groups were established and the director's telephone numbers of the pharmaceutical department have been released on the hospital lan website , which can help physicians to satisfy the needs of drug supply and use. ( ) in order to resolve drug delivery lately in the epidemic, pharmacists have made use of the information network technology, applied the " iot collaborative service platform for drugs" to drug procurement ( figure for workflow).the platform automatically generated orders based on previous sales status from his ((hospital information system), which could be modified and submitted by pharmacists. the orders were transmitted to suppliers by internet without delaying, then medicines were delivered according to orders timely. the platform have allowed hospitals and suppliers to share information, optimized the drug procurement workflow, improved the efficiency, saved the labor and material resources, and reduced infectious risk caused by cross contact in the drug purchase process as much as possible. ( )donated medicine management affected by the epidemic, a shortage of drugs and protective materials has drawn public attention. thju received a great many of donations, such as masks, protective clothing and medicine. therefore, the management of donations is a new task. thju had formulated a management process (figure ) of donations in accordance with laws, and the pharmaceutical department was responsible for managing donated drugs. (see table ( )safe working environment is an important condition to ensure the progress of diagnosis and treatment. in order to reduce the spread of the virus through person-to-person transmission during the coronavirus epidemic, outpatient pharmacy of thju are disinfected times everyday. pharmacists of outpatient pharmacy also designed safety transfer devices to avoid contacting patients in drugs dispensing. otherwise, pharmacists adjusted the route and time of drug transportation in the hospital and used designated elevators and vehicles for drug delivery. through these practices, thju has carried out successful drug supply management without drug shortages or drug delays. up to now, there has been no nosocomial infection related to pharmacy. the off-label drug use may rise greater potential drug use risks, pharmacists emphasize on adverse drug reactions(adr), use the "adverse drug reaction monitoring system of medical institutions" to monitor the adverse reactions of off-label drugs, evaluate the causal relationship of adverse drug reactions and feed back the evaluation results in time. at present, antiviral drugs for covid- have not been approved for marketing, prescribing antiviral drugs , such as lopinavir/ritonavir and ribavirin, for patients with covid- could be defined as off-label drug use, the treatment is lack of clinical experience. the incidence of severe adr in off-label using was significantly higher than normal use , such as anaphylactic shock, drug-induced liver damage and induced epilepsy, was prone to occur in off-label drug use cases. pharmacists carried out monitoring adr, evaluated and analyzed the symptoms of patients, and provided doctors with adr information. during treatment, few new serious adr occurred. in addition, pharmacists participated in the multidisciplinary diagnosis and treatment of covid- patients, conducted nutritional risk screening and designed nutritional support programs. during the outbreak, all covid- patients were cured and discharged. timely pharmaceutical care are critical for treatment during the coronavirus pandemic. pharmacists have made a pharmaceutical care procedure (figure )according to needs of different groups, provided updated treatment plans, monitored potential drug interactions, focus on special population medication and implement remote pharmaceutical service. figure pharmaceutical care procedure the cnhc has released the "diagnosis and treatment guidelines for the new coronavirus infected pneumonia", currently in its seventh update. to have a better grasp on the latest version of diagnosis and treatment plans for frontline physicians, pharmacists made a list of changes (table ) . list of changes in diagnosis and treatment plans for covid- pharmacists also provided a list of common risk warnings of potential drug interactions and reactions according to covid- diagnosis and treatment plans combined with literatures (table ) . table list of potential drug interactions and reactions [ ] [ ] pregnant women, especially in middle and terminal pregnancy, are prone to develop into severe patients after infecting with covid- . gestational age, and whether to terminate the pregnancy after treatment has been considered in the therapy . older adults are often associated with a variety of chronic diseases and have a higher risk of death if infected with covid- . physiological characteristics and combination of drugs will change pharmacokinetics and affect the efficacy. therefore, individualized pharmaceutical care have been provided in combination with physiological characteristics and disease progression . pharmacists used "prescription approval & prospective audit and feedback system" to carry out online prescription reviewing. the thju network and "pharmacists by your side" (wechat subscription) was applied to provide free drug consultation to resolve problems of drug use. pharmacists publicize the prevention and control of covid- to the public free of charge online. these practices of online pharmacy services provide accessible pharmaceutical care and help to reduce the risk of cross-infection during unnecessary hospital visits. in the fight against the epidemic, hospitals are facing difficulties in personnel, drug supply and pharmaceutical care. the pharmaceutical department have established effective drug supply and pharmaceutical care practices, and provided a strong guarantee for epidemic prevention, control and treatment. on march , who has made assessment that covid- could be characterized as a pandemic and many countries and regions are now experiencing the difficulties that our country once faced. pharmacists summarize the management model and experience to provide reference for those who in the same predicament. post-epidemic era, pharmacists should remain engaged in the coordinated efforts and be readily adaptive to changes required in drug supplying and pharmaceutical care. 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of the people's republic of china．notice on novel coronavirus infection prevention and control technical guidelines (first edition) in medical institutions national health commission of the people's republic of china national health commission of the people's republic of china. diagnosis and treatment of covid- (version ) standing committee of the ninth national people's congress. law of the people's republic of china on donation of public welfare undertakings (order no. of the president of the people's republic of china) the adverse drug reaction evaluation and case analysis by using naranjo probability scale analysis of off-label drug uses in adverse drug events of our hospital pharmaceutical emergency guarantee difficulties and countermeasures for the prevention and control of outbreak of novel coronavirus pneumonia(ncp) national health commission of the people's republic of china et al．novel coronavirus control and prevention strategy: pharmaceutical guidance and management strategy covid- treatment protocol (drug information) compilation recommendation for the diagnosis and treatment of novel coronavirus infection in children in hubei (trial version ). chin j contemp pediatr et al．pharmacological care strategy for antivirals in patients with covid- complicated by underlying disorders et al．hospital pharmacy administration and pharmaceutical care in the prevention and control of corona virus disease- this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. key: cord- -z ondg r authors: jacobsen, kathryn h.; hay, m. cameron; manske, jill; waggett, caryl e. title: curricular models and learning objectives for undergraduate minors in global health date: - - journal: annals of global health doi: . /aogh. sha: doc_id: cord_uid: z ondg r background: a growing number of institutions of higher education offer undergraduate educational programs in global health. objective: to identify all undergraduate minors in global health being offered in the united states during the – academic year, categorize the curricula being used by secondary programs of study, evaluate the content of required foundational courses, and examine the types of experiential learning opportunities that are offered. methods: a working group of the consortium of universities for global health (cugh) conducted a systematic review of the websites of all accredited -year colleges and universities, identifying institutions offering general global health minors. findings: a typical global health minor consists of one introduction to global health course, one epidemiology or health research methods course, several additional required or selective courses, and one applied learning experience. within this general structure, five curricular models are currently being used for global health minors: ( ) intensive minors composed of specialty global health courses, ( ) global public health minors built on a core set of public health courses, ( ) multidisciplinary minors requiring courses in the sciences and social sciences, ( ) anthropology centric minors, and ( ) flexible minors. conclusions: cugh recommends ten undergraduate student learning objectives in global health that encompass the history and functions of global health; globalization and health; social determinants of health; environmental health; health and human rights; comparative health systems; global health agencies and organizations; the global burden of disease; global health interventions; and interdisciplinary and interprofessional perspectives. bulletin and/or the webpages for relevant departments. we minimized our risk of overlooking relevant programs by validating our searches of institutional websites with general search engine queries pertaining to global health majors, minors, concentrations, and certificates. we defined a minor as a secondary program that complements a primary area of study in a bachelor's degree program. we classified secondary programs of study requiring at least semester credit hours (or the equivalent in quarter hours, course counts, or other institutional-specific terms) as minors. curricular pathways requiring fewer than semester hours or the equivalent, such as short-term study abroad programs and certificates requiring only three courses (equivalent to semester hours or fewer), were not considered to be minors. global health concentrations embedded within minors in other disciplines (such as public health) or interdisciplinary areas (such as global studies) were included when more than half of the credits in the minor were allocated to the global health concentration. in this paper, we use use the term minor for all programs that met the inclusion criteria, even though some schools call these secondary programs certificates or use other names for them. global health is still in the process of being defined as an area of academic study, but it is generally considered to be distinct from public health, which tends to have a focus on health promotion in one community or one nation [ , ] . to be eligible for inclusion in the analysis, a minor had to be focused on global health (rather than public health, global affairs, international development, medical anthropology, population health, or other areas that overlap with global health but do not have global health as the central focus) and cover global health broadly rather than focusing on just one specialty area within global health (such as maternal and child health). most of the included programs were named global health ( ), global public health ( ) , or global health studies ( ) . other program names included community and global health; global health and health policy; global health and social medicine; public health: global health; global and comparative public health; global health and development; global health and humanitarian assistance; global health promotion; global health service; global health technologies; global health, culture, and society; global public health and epidemiology; global public health and the common good; international health; medicine, health, and society: global health; public and global health; and social justice in global health. for each institution with a global health minor that met our inclusion criteria, we acquired location, institutional enrollment, and other information from the carnegie classifications data public data file (version , released on september ) produced by the indiana university center for postsecondary research. we accessed the cur-ricular and co-curricular requirements for the minor and extracted key details about required courses (title, course level, and hosting department), the thematic areas in which students were required to select one or more courses from a list of approved courses (such as students being required to select one research methods course from a list of two or more preapproved courses), and co-curricular requirements such as field experiences, research or capstone projects, or synthesis capstone courses. since most of the minors required a course that introduced the fundamentals of global health, we also acquired the course descriptions for each required introduction to global health course from the catalog (or bulletin) or program website of each school. we applied grounded theory to the coding of each required element of the curricula of included minors, using several rounds of individual coding, group discussion, and recoding to reach consensus about the codes for each curricular element. the codes noted the disciplinary area for each course (such as biology or statistics), the type of course (such as introductory, methodological, or experiential), and the specific focus (such as environmental health or medical anthropology). related codes were grouped into categories. we then looked for patterns in the sets of categories that were required curricular components, seeking to identify themes that aligned with three or more institutions. a final set of five curricular models is presented in the results section. we used a similar process to code the course descriptions of introductory global health courses and establish interrater reliability. to ensure the comprehensiveness of our coding, we separately coded three specific content areas for each course: ( ) health and disease topics, such as environmental health, hiv/aids, reproductive health, nutrition, noncommunicable diseases, and violence; ( ) populations, agencies, and organizations, such as children, low-income countries, refugees, women, health systems, and the world health organization; and ( ) theories and themes, such as globalization, social justice, and multidisciplinarity. we then reviewed the codes, categorized them, and identified the themes that were most often expressed in the course descriptions. our search identified colleges and universities that offered minors in global health during the - academic year, including three schools for which two different programs met our definition of minors in global health (for a total of minors). all schools were nonprofit -year institutions, but they represent diversity within this sector of higher education. they were nearly equally divided between public universities and private schools. of the institutions, were doctoral universities, were master's universities, and were baccalaureate colleges (all of which were designated in the carnegie classifications as awarding more than half of their bachelor's degrees in arts and science fields rather than awarding the majority of their degrees in professional areas such as business and engineering). forty-seven of the schools had a large undergraduate enrollment (≥ , ), medium ( - ), small ( - ), and very small (< ). in total, of the schools had undergraduate admissions rates that were designated in the carnegie classifications as "more selective" (the th to th percentile of selectivity among undergraduate institutions, based on sat and act percentiles and the admission rate), as "selective" (the th to th percentile of selectivity), and as "inclusive." based on the four location classifications used by the national center for education statistics (nces), of the schools were in cities, in suburbs (that is, within urbanized areas but outside of principal cities), in towns (outside of urbanized areas), and none in rural areas. many of the schools with global health minors offered other health-related educational programs, including offering an mph degree (including with an mph concentration in global health), offering an undergraduate major in public health, offering a medical degree (md, dds, dmd, do, or dvm), and offering an undergraduate minor in public health. thirteen offered an undergraduate major in global health, and at least a dozen additional schools offered a secondary major in global health or a concentration in global health within another major, such as public health or global studies. an introduction to global health course was required by % ( / ) of the included minors. the interdisciplinary nature of global health was evident in the prefixes for the introductory courses (one of which was required by two different minors at the same institution). in addition to catalog prefixes specific to global health, public health, health science, health administration, and other health fields, these introductory courses were also offered by africana studies, anthropology, biology, international studies, kinesiology, nursing, nutrition, political science, and sociology departments as well as by interdisciplinary programs. the topical themes featured most frequently in the descriptions of introduction to global health courses included the social and environmental determinants of health; the global burden of disease, often described using terms such as epidemiology, demography, data, and methods; global health agencies and organizations; governance and comparative health systems; and interventions related to exposures, diseases, and special populations. the conceptual themes that were expressed most often in introductory global health courses (that is, the cross-cutting themes that were not consistently associated with specific exposures, diseases, and populations/ groups) included multidisciplinarity or interdisciplinarity; globalization; health disparities and inequalities; ethics, human rights, and social justice; problem solving; and the historical context for global health today. the introductory course was the only curricular component required by a strong majority of programs. about half of the current global health minors ( / ) required at least one course on epidemiology, statistics, and/or the research methods used in public health or the social sciences. other popular clusters in which courses were required for global health minors included, in decreasing frequency, courses on health, culture, and society; the biology of health and disease; health policy and economics; and environmental health and sustainability; and ethics, human rights, and social justice. thirty-eight ( %) of the global health minors required some type of capstone experience or another type of applied or experiential learning. while some of the programs mandated that all students in the minor complete the same type of capstone experience-such as all students completing a practicum or internship ( ), a research project ( ), a capstone course with an experiential component, such as service-learning or problembased learning ( ), study abroad ( ), an applied project ( ), or a reflective portfolio ( )-the most common option was to allow students to choose from a list of approved experiential learning activities ( ) . only five minors required an international experience. based on the most frequently required curricular elements, the general framework for a global health minor includes one introduction to global health course, one epidemiology or health research methods course, several additional courses exploring different domains of global health, and some type of applied learning experience ( figure ) . however, few schools strictly follow that model in its entirety. there is considerable variability in which domains of global health are emphasized and how rigid the curricula are. at some schools, every student who earns a global health minor completes the same set of five (or more) courses; at some other schools, students select their own courses for the minor from a long list of "selective" courses. based on our evaluation of the curricular structures of the global health minors, we identified five curricular models being used for global health minors ( table ). intensive global health minors are built around a series of specialty courses in global health, such as courses on global environmental health, global health policy and systems, and global health leadership. most of the universities offering this track were doctoral universities with large undergraduate enrollment. the majority of the intensive global health minors were offered by a school of public health or health professions that also offers an undergraduate major, master's degree, or graduate certificate in global health. about half ( / ) of the intensive minors required some type of capstone experience, most often a practicum. global public health minors are built on the three building blocks for undergraduate public health education that were published by the association of american colleges and universities (aac&u) and the association for prevention teaching and research (aptr) in : introductory courses in public health, epidemiology, and global health [ ] . global public health minors were offered by schools, including that include "public" in the names of their global health minors. global public health programs were often housed in departments or schools of public health at universities that did not offer global health majors. only a few ( / ) global public health minors had an experiential learning requirement. multidisciplinary global health minors require students to take courses from several departments to fulfill course requirements, including at least one natural science course (typically biology or environmental science) and at least one social science course. multidisciplinary minors were offered by schools, including six of the baccalaureate colleges and eight of the small schools. their program descriptions typically emphasized the value of learning about health from a diversity of disciplinary perspectives. most of these schools did not offer undergraduate public health majors or minors or mph degrees. multidisciplinary minors were often hosted by the interdisciplinary or interdivisional unit of a college of liberal arts and sciences rather than being overseen by one academic department. more than half ( / ) of the multidisciplinary minors required some type of a capstone experience, with students typically being allowed to choose from a variety of approved experiential learning opportunities. anthropology global health minors require several courses in anthropology, sociology, and related disciplines. this type of minor was offered by eight schools, including three with "social justice" or "social medicine" in the names of their global health minors. most of these programs required at least one course in medical anthropology or a closely related area, and several include an introductory anthropology course among the requirements for the global health minor. most of these programs were housed in anthropology departments or in social science divisions at public doctoral universities that did not offer any other baccalaureate or graduate programs in global health. experiential requirements were not common ( / ) in anthropology global health minors. a flexible global health minor built from elective courses is offered by schools. these programs typically require an introductory global health course and some sort of capstone experience related to global health (such as a research project, experiential learning activity, or seminar), but they allow students considerable flexibility in choosing the other courses they take for the minor. flexible minors are different from multidisciplinary minors because they do not have distribution requirements spanning several mandated areas of study. most flexible minors were offered at schools that do not offer a public health major or minor. flexible minors were housed in interdisciplinary units, colleges of liberal arts and sciences, special centers focused on health or global one of the major challenges for global health as an academic discipline is the lack of national or international standards for what content should be included in the curriculum. for schools that offer global public health, multidisciplinary, anthropology, and flexible global health minors, it is critical for the introductory global health course to provide a comprehensive overview of global health theory and practice that equips students with a broad knowledge foundation that they can build on when they take advanced or elective courses within the minor. our analysis of the content of introductory global health courses found that most courses cover a similar set of concepts and subject matter content. however, there was no standard set of learning objectives available to schools that were creating new global health courses or revising existing ones. in our role as members of the cugh working group tasked with developing evidence-based resources for undergraduate education in global health, we decided to use our analysis of current course content and our familiarity with existing resources for teaching and learning in global health as a foundation for a draft list of candidate learning objectives for global health survey courses in north american colleges and universities. two organizations' documents provided a starting point for prioritizing content. one is cugh, which has developed interprofessional global health competencies that span levels from "global citizen" to "advanced." [ ] the lowerlevel competencies that focus on understanding global health theories and preparing for experiential learning with host organizations that serve people with different cultural and socioeconomic backgrounds are appropriate targets for undergraduates [ ] . the other is the council on education for public health (ceph), which accredits public health degree programs. ceph has identified essential components of undergraduate public health education and created a list of foundational knowledge areas in public health [ ] [ ] . while the ceph accreditation standards do not specifically address global health, they outline areas of undergraduate study that prepare students for entry-level practice and graduate studies in various areas of the population health sciences [ ] . we also examined the competencies for global health education proposed by international groups for students and trainees in medicine, public health, and other areas [ ] . together, the educational frameworks of cugh, ceph, and international groups point toward potential priorities for undergraduate global health courses and programs. based on the categories and themes we identified in our analysis of the current content of introductory courses required by existing global health minors in - , our review of existing educational frameworks related to global health [ , , ] , and expert feedback from cugh members, we generated a preliminary list of recommended student learning objectives for an introductory global health course. this list included central global health principles, such as globalization and health equity, plus foundational knowledge areas related to the determinants of health, the major causes of morbidity and mortality, and the entities involved in funding and implementing global health interventions. after several rounds of revision and refinement, a final set of ten cugh recommended undergraduate global health student learning objectives was reviewed by members the cugh education committee and the cugh secretariat, and then endorsed by cugh ( table ) . the cugh recommended undergraduate global health student learning objectives are not meant to be an exhaustive list of all global health principles and themes. however, including these ten items alongside institutionspecific learning goals and competencies will ensure coverage of critical global health knowledge and skill areas. these learning objectives are applicable to introductory global health courses housed in diverse academic units. if the verbs used for each item (such as define, explain, compare, and evaluate) are scaled up to higher order thinking skills, these items could also form the basis for programlevel learning goals for an entire global health program, such as a certificate, minor, or major. rather than dictating the specific topics that a survey course should address-like naming the exact diseases and populations that should be examined in an introductory course-these learning objectives provide a framework for exploring a variety of global health issues. for example, although pandemics are not directly named within these ten items, the components of the emergency management cycle (prevention, preparedness, response, and recovery) align with many of the learning objectives. global health security is one of the functions of global health (learning objective # ). pandemics arise from globalization (# ) as well as from human behavior (# ) and environmental interactions (# ). the responses to pandemics, such as mobility restrictions, may raise questions about human rights (# ). pandemics like covid- place a heavy burden on medical care providers (# ) and require substantial investment in public health interventions like contact tracing (# ). case studies about the coronavirus pandemic provide opportunities to compare the epidemiological profiles of different populations (# ), examine which interventions are effective in various demographic groups (# ), and think creatively about what policies and practices might prevent another emerging infectious disease pandemic (# ). while students will benefit from exposure to a wide range of health issues, not just one, in their introductory global health courses, these learning objectives allow the flexibility to adapt courses to emerging health issues and local priorities. in many academic disciplines, a minor comprises a subset of courses from the corresponding major. for example, the american psychological association provides strong guidance about the knowledge and skill components of foundational, intermediate, advanced, and capstone courses in a psychology major, and it recommends that a minor require completion of about four foundational courses rather than being based on one introductory psychology course plus higher-level coursework [ ] . the american chemical society's educational standards list the specific subdisciplines in which coursework is required for a major in the field [ ] , and although acs has issued no standards for minors in chemistry, it is typical for minors to consist of the foundational courses plus a subset of the advanced courses from the major. however, this "minors as mini-majors" approach will not work in global health, since few schools currently offer global health majors and there is not yet consensus about what types of courses are important for a major in global health [ ] . when minors are not derived from majors, they are often designed around interdisciplinary themes. for example, public health minors offered by diverse types of institutions often consist of three foundational courses (epidemiology, u.s. public health, and global health) plus a few "selective" courses (that is, courses selected from lists of approved course options) and at least one experiential learning activity [ , ] . this structure is similar to the curricular plan used by many global health minors (and featured in figure ) . we identified five variants of this general structure that are currently being used for global health minors. these models are characterized based on whether they are built around specialty courses in global health (intensive) or public health (global public health), require taking courses in several different departments (multidisciplinary) or primarily in one department (anthropology), or are relatively unstructured (flexible). each of the five curricular models used by global health minors has its own set of curricular and programmatic strengths and weaknesses ( table ). minors that align with the intensive and global public health models may provide the most comprehensive exposure to global health principles and practices, but they require substantial institutional investments in courses specific to the minor. these resource demands make these models most suitable for large schools that already offer many courses on global health topics as part of a public health or global health major. minors that align with the multidisciplinary or flexible models may allow students the greatest freedom to individualize their studies to match personal interests and goals, but even with strong advising these loosely-structured programs may leave students with critical gaps in their understanding of global health. given the diversity in course requirements across the current minors, even when looking at minors that apply the same general type of curricular model, it would be premature to recommend a set of standard courses for global health minors. however, all courses that count toward a minor should build on the undergraduate student learning objectives introduced in the fundamentals course, and all should have health as a central theme. schools lacking the resources to offer a variety of specialized global health courses should still verify that all courses that count toward the minor engage with global health in a meaningful way. general courses in anthropology, biology, communication, economics, environmental science, government and policy, philosophy, sociology, and other areas are unlikely to provide sufficient engagement with global health themes; by contrast, health-specific courses such as medical anthropology, health communication, and environmental health are likely to engage more closely with global health principles and practices. similarly, applied learning experiences completed as part of global health minors should require students to synthesize and reflect on the global health knowledge areas and competencies spelled out in the undergraduate student global health learning objectives. many types of experiential learning opportunities may be suitable for undergraduates [ ] . experiential learning does not require international travel, and it can involve student engagement with a diversity of clinical and non-clinical professional practice areas within the governmental, nonprofit, and commercial sectors. (mentors should ensure that students do not perform beyond the scope of their training, especially in clinical settings.) schools where institutional resources are not available to offset the burden that experiential learning activities can place on students, faculty mentors, and community hosts may opt not to require applied learning experiences for all students minoring in global health, but they can still recommend experiential learning as an optional curricular component. our results imply that . % ( / ) of all -year colleges and universities offered minors in global health in - , but since some schools that award bachelor's degrees do not offer minors in any discipline, the true percentage is greater than . %. we used a systematic approach to attempt to identify all the colleges and universities offering global minors in - , but it is likely that our months-long review process missed some programs. global health is a recently launched curricular offering at many schools, and some websites might not have been updated at the time we conducted our review of their institutional webpages. the curricular trends we observed across general global health minors are unlikely to be affected by one or more programs being overlooked. our count of minors in global health intentionally omits minors in specialty fields related to global health and minors in areas such as public health, population health, and medical anthropology that overlap with global health but are distinct fields of study. if our eligibility criteria had used a broader definition of global health, there would be well over minors included in the tally. the count also intentionally excludes several new global health minors that were announced in or earlier but were not beginning enrollment until the - academic year. this analysis provides a snapshot in time of the institutions of higher education in the untied states that were offering global health minors during the - academic year along with the content they included in their introductory courses, the curricular models they were using for the remaining courses in the minor, and the types of applied learning experiences they required. it also introduces the cugh recommended undergraduate global health student learning objectives, summarizes the general framework used by the typical global health minor, and describes the models that schools use requires significant institutional resources specific to global health; courses taught by experts in focused areas of research and practice may offer depth at the expense of disciplinary or professional breadth global public health emphasizes a set of core public health courses (introductory courses in epidemiology, global health, and u.s. public health policy) for which resources are available to support instructors without specialized training in global health treats global health as a subdiscipline of public health rather than as a multidisciplinary field that overlaps public health while drawing on other academic and professional areas; the public health core leaves few credits for courses specific to global health multidisciplinary applies a liberal arts lens to global health education by requiring students to examine complex issues from the perspectives of the natural sciences, social sciences, and (sometimes) the humanities; requires limited institutional investment in courses specific to the global health minor demands that a single introductory global health course cover a wide range of global health principles and practices, because electives in supporting disciplines might only peripherally touch on topics specific to global health (such as a course in environmental science only briefly examining global environmental health concerns) allows students majoring in fields other than anthropology to deeply understand anthropological theories and methods as they apply to global health focuses narrowly on anthropological (and sometimes also sociological) approaches to global health, providing limited exposure to biological and public health perspectives flexible allows students the greatest freedom to craft their own programs of study that best align with their academic and professional interests; requires limited institutional investment in courses specific to the global health minor requires intensive advising to ensure that each student's unique set of curricular and co-curricular learning experiences provide some sort of coherent engagement with global health and enable the student to synthesize, integrate, and apply central global health principles to structure their minor curricula. we expect that the number of schools offering global health minors will increase over the next few years in response to student demand driven by the coronavirus pandemic as well as by other ongoing global challenges, such as climate change. the recommended learning objectives and curricular framework presented in this paper provide schools with tools they can use to design minors that align with disciplinary norms and with institutional goals, values, and resources. global health and public health majors and minors at universities the emergence of undergraduate majors in global health: systematic review of programs and recommendations for future directions teaching global public health in the undergraduate liberal arts: a survey of colleges an analysis of undergraduate educational programs in global health trends in public and global health education among nationally recognized undergraduate liberal arts colleges in the united states master of science (ms) and master of arts (ma) degrees in global health: applying interdisciplinary research skills to the study of globalization-related health disparities master of public health (mph) concentrations in global health in : preparing culturally competent professionals to address health disparities in the context of globalization health promotion practice from sovereignty to solidarity: a renewed concept of global health for an era of complex interdependence towards a common definition of global health curriculum guide for undergraduate public health education (version . ) identifying interprofessional global health competencies for st -century health professionals accreditation criteria: schools of public health & public health programs accreditation criteria: standalone baccalaureate programs what is population health? a review of global health competencies for postgraduate public health education. front public health apa guidelines for the undergraduate psychology major (version . ) acs guidelines and evaluation procedures for bachelor's degree programs developing an undergraduate public health introductory core course series. front public health association of american colleges and universities (aac&u)/association for prevention teaching and research (aptr) how do we teach for global health? reviewing and renewing to advance pedagogy for global health and health promotion this work was conducted by the subcommittee on master's and undergraduate degrees in global health of the consortium of universities for global health (cugh). the authors thank the members of the education committee and the cugh secretariat for their insights and support. the authors have no competing interests to declare. key: cord- - ldynibm authors: woldehanna, sara; zimicki, susan title: an expanded one health model: integrating social science and one health to inform study of the human-animal interface date: - - journal: soc sci med doi: . /j.socscimed. . . sha: doc_id: cord_uid: ldynibm zoonotic disease emergence is not a purely biological process mediated only by ecologic factors; opportunities for transmission of zoonoses from animals to humans also depend on how people interact with animals. while exposure is conditioned by the type of animal and the location in which interactions occur, these in turn are influenced by human activity. the activities people engage in are determined by social as well as contextual factors including gender, age, socio-economic status, occupation, social norms, settlement patterns and livelihood systems, family and community dynamics, as well as national and global influences. this paper proposes an expanded “one health” conceptual model for human-animal exposure that accounts for social as well as epidemiologic factors. the expanded model informed a new study approach to document the extent of human exposure to animals and explore the interplay of social and environmental factors that influence risk of transmission at the individual and community level. the approach includes a formative phase using qualitative and participatory methods, and a representative, random sample survey to quantify exposure to animals in a variety of settings. the paper discusses the different factors that were considered in developing the approach, including the range of animals asked about and the parameters of exposure that are included, as well as factors to be considered in local adaptation of the generic instruments. illustrative results from research using this approach in lao pdr are presented to demonstrate the effect of social factors on how people interact with animals. we believe that the expanded model can be similarly operationalized to explore the interactions of other social and policy-level determinants that may influence transmission of zoonoses. the current ebola outbreak in west africa (cdc, ) , and to a lesser extent the outbreak of middle east respiratory syndrome (mers), first identified in saudi arabia in (cunha and opal, ) have galvanized the world's attention on the dangers posed by zoonotic infections. however, these are only the latest in a series of outbreaks of novel diseases in humans during the last decade of the th century highlighting the need for focus on the zoonotic (animal) origin of viral infections. for instance, avian influenza h n was identified in hong kong in (mounts et al., ) ; rift valley fever caused an estimated , human infections and reported loss of approximately % of livestock (primarily sheep and goats) in garissa district, kenya, in e with reports of disease in four other provinces in kenya as well as in somalia and tanzania (woods et al., ) ; an outbreak of nipah virus in malaysia in e caused at least human cases of encephalitis and deaths (chua, ) with an estimated . million pigs culled in efforts to stop transmission (fao and aphca, ) ; and outbreaks of west nile virus occurred in europe from to (hubalek and halouzka, ) and the united states beginning in (who, ) . in taylor and colleagues (taylor et al., ) inventoried known human infectious disease pathogens and pointed out that % of all pathogens and % of emerging disease pathogens were zoonotic in origin. about % of human viral pathogens are zoonotic (morse et al., ; taylor et al., ) . the importance of viral zoonoses was emphasized with the emergence of sars coronavirus in e and the reappearance of h n in hong kong in , followed by its spread throughout asia, the middle east, europe and sub-saharan africa by (who, . the pace of new outbreaks led to increasing recognition that emerging infectious diseases originate at the interface of human and animal ecosystems. this recognition underscored the need for an inter-disciplinary approach to dealing with transmission and was one of the main factors leading to creation of the one world one health tm movement. at a conference convened by the wildlife conservation society at the rockefeller university in , the movement gained its trademarked name and issued a call to action, embodied in the "manhattan principles" for preventing emerging diseases in human and animal population and maintaining ecosystem integrity (wcs). by , the un agencies and the world bank had drafted a strategic framework, introduced at the "one world, one health: from ideas to action" conference in winnipeg, canada, in (phac, . the premise of one health is that people, animals and the environment form an interdependent ecosystem that needs to be considered in a coordinated manner (fao et al., ; frank, ) . it rests on a conceptually simple model that focuses on contact e and therefore the potential for transmission of disease e between wild and domestic animals and humans (usually depicted as three overlapping circles) in the context of the environment. this model has worked well as an advocacy tool to present the case for coordination in detecting and responding to outbreaks. it has also fostered discussions on the factors that are contributing to spillover of diseases from animals to humans, the first step in an outbreak. most of the discussions to date about drivers of emergence (daszak et al., ; a. dobson and foufopoulos, ; karesh et al., ; patz et al., ; smolinski et al., ) have focused on anthropogenic land use changes e essentially resource exploitation (logging, mining, establishment of plantations, dam building) and associated road building and pollution. these factors are fundamental drivers of disease emergence in wildlife through their effects on habitat fragmentation, biodiversity and hostpathogen dynamics. a second set of frequently mentioned drivers focuses on movement of hosts and pathogens through travel and the transport and trade of animals and animal products. finally, increased human-animal contact occurs because of increasing human population density and its consequences e encroachment of humans into previously undisturbed areas and the development of larger scale or more intensive animal production systems (slingenbergh et al., ) . while these large-scale changes and interactions may provide the potential for contact between humans and animals, opportunities for transmission e that is, the initial spillover event e also depend on specific human activity at the local level: if, how, where and when people interact with animals (k. a. alexander and mcnutt, ) . for example, chua et al. ( ) suggested that the first documented outbreak of nipah virus in malaysia was precipitated by a combination of ecological and social factors. the ecological factors included el ni no-cycle related drought, land use change (deforestation and reduced habitat for fruit bats due to logging) and fire arising from slash and burn agriculture that displaced bats to orchards in ipoh. in addition, key factors included local practices regarding location of piggeries in and near fruit orchards and pigsties constructed so that water run-off from roofs e and fruit dropped by bats e was directed into the pigsty. the result was that pigs were able to eat bat-saliva-contaminated fruit, became infected and then infected their handlers. this example supports the importance of the land use change drivers, but also suggests the importance of other, more proximate determinants of contact e in this example, the siting of piggeries and pigsty construction. for preventing, or at least slowing, the emergence of new diseases e and for more efficient response to outbreaks e we need to have a better understanding of these proximate determinants. one route to preventing recurrence of nipah virus at pig farms would be to implement policies and regulations addressing the "upstream" land use changes that eventually led to emergence. a second, complementary route is through interventions affecting what chua calls "the pattern of pig and orchard farming" (chua et al., ) ; that is, human activities at the local level. a first step in this approach is discerning those patterns. having a model of proximate determinants facilitates this activity. in this paper we propose an expanded one health model that highlights the social determinants of human-animal exposure, describe a study approach that operationalizes the model to explore factors that influence the risk of transmission at the individual and community level and present some results that illustrate the effect of social factors on how people interact with animals. . an expanded one-health model the expanded one health model we propose gives serious consideration to all the factors, both social and ecological, that can contribute to disease emergence at the local level. in the expanded model ( fig. ) , the probability of zoonotic disease spillover is a function of contact between humans engaging in different activities and infected animals they encounter during those activities. as our primary interest is emerging pandemic threats, in developing the model we considered what we know about emerging viral diseases transmitted from animals to humans by direct or indirect contact; these comprise about a quarter of all emerging zoonotic diseases (calculated from table in taylor et al. ( ) . the model would need further expansion to account for proximate determinants of the emergence of other kinds of diseases of zoonotic-origin: vectorborne diseases, drug resistance, bacterial, fungal or helminthic infections. any specific spillover event involves one or a small number of animals and one or a small group of individuals (e.g., family members or a hunting party). from the animal side, the probability of transmission to humans is primarily affected by the prevalence of infected animals, which could be wild or domestic. there is a lively debate about the proximate determinants of prevalence, which may include animal biology, pathogen ecology, animal density, biodiversity and animal movement, among others (keesing et al., ) . on the human side of the model the probability of spillover transmission from animals is primarily affected by the likelihood of someone encountering an infected animal or its excreta, determined by the frequency with which people come in contact with specific types of animals that might carry infections and the type of contact they have with animals; that is, by the types of activities in which they engage. human activity is influenced by a complex range of factors along the socio-ecological continuum (riekert et al., ) which may act separately or in tandem. key categories include: biological characteristics of individuals; social characteristics of individuals, households and communities, including norms, livelihood systems and settlement patterns; and finally, at the public policy level, local and international governance and politics (see table for examples of key elements in each category). complex social dynamics determine the type and frequency of engagement of any individual, family or community in specific activities involving possible interactions with animals, as well as the intensity of interactions and thus potential exposure to pathogens. at the simplest level, socially-determined roles for individuals of specific gender, age and education affect both the range of possible occupations and division of labor; for instance, women may cook and men slaughter. individuals engaged in occupations related to animals (hunting, butchering and caring for animals, etc.) or working in agricultural areas or forests are obviously at increased risk compared to the general population. household characteristics, including family structures and socio-economic status, can determine if and how families are exposed. these relationships can be complex. for example, while families that hunt for food tend to be poorer and less educated than families that purchase food, poverty is a predictor of only one kind of interaction with specific types of wild animals. wild animal meat purchased in markets is frequently more expensive than domestic animal meat; a market survey carried out by wcs and fhi in laos (unpublished) showed that brush-tailed porcupine meat cost three times as much as domestic pork per kilogram. in addition, within-family dynamics can affect who gets exposed and with what frequency and intensity. as an example, family type e e.g. single parent, nuclear family or extended e will affect whether and how intensely children are socialized to hunting or what food allocation rules are practiced to determine who gets to eat what part of the animal (whitehead, ) . availability of markets, goods and services, the strength and type of social networks, and proximity to natural resources can affect community dynamics leading to greater or less exposure to animals. for instance, a study conducted in several african countries showed that while more wealth was associated with less bush meat consumption in rural communities closer to source of wild life harvest, it was associated with more bush meat consumption in urban communities (brashares et al., ) . various social forces such as conflict or forced or voluntary migration can also change peoples' relationships to the environment and animals (de merode et al., ; fauna and flora, ) . social norms can affect interactions with animals and potential exposure to zoonotic pathogens in many ways (e.g., which if any animals are preferred for eating and what types of preparation are acceptable, or what kinds of animals are considered suitable for pets e or for children to play with). various customs with regards to specific animals may serve different social functions that can shed light on other determinants of exposure. for instance, hunting some animals may confer certain social standing in the community and sharing the products of a hunt maybe used as a way of incurring favors (gurven and von rueden, ) . food taboos related to animals, often applied differentially to subgroups (e.g. children, pregnant women, individuals from different castes), can serve several purposes including protecting health, marking special events, protecting or allocating scarce resources, or creating group cohesion (meyer-rochow, ). settlement patterns affect the variety and number of animals to which people might be exposed. for example, how houses are constructed, which may be associated with ethnicity and/or socioeconomic status, may determine risk of rodent infestation (bonner et al., ) . rodent abundance is also affected by location of housing relative to different types of animal habitat and open water sources and to waste disposal sites (bonner et al., ; masi et al., ; promkerd et al., ) . it is important to note that while increasing urbanization produces habitats unsuitable for many species of animals, urban-adapted wild animals can occur at higher densities in urban and peri-urban areas than in more rural areas (bradley and altizer, ) . finally, governance and politics, from local to international levels, can affect not only the extent and impact of some of the anthropogenic land use changes mentioned above but also social dynamics at all levels to influence who gets exposed and with what frequency and intensity. our expanded model increases the level of detail of the one health framework and strengthens the foundation for understanding the interplay of factors that lead to disease emergence. below we describe a research approach based on this expanded model. the human-animal exposure study was developed to document the extent of human exposure to animals and begin to explore the interplay of social and environmental factors that influence risk of transmission at the individual and community level. the study aims to identify groups who are at particular risk of transmission of infections and the (potentially modifiable) factors contributing to that risk. in southeast asia the human-animal exposure study has been conducted in selected locations in thailand and lao pdr. in thailand the study was implemented in urban and rural locations inhabited by the same ethnic group (the i-san). in lao pdr, the study examined differences in exposure between two culturally different ethnic groups (hmong, lao-tai) living in the same location. both of these studies received formal ethical approval from the fhi protection of human subjects committee (fhi 's irb) and an irb in the country in which they were conducted. informed consent was obtained from all participants; in the case of children, we obtained the child's assent and informed consent from a parent. below we use examples from these settings to illustrate our discussion of the factors important in implementing such an approach. one research objective suggested by the model is to improve understanding of the interaction between culture and ecology in determining potentially risky human-animal exposure. fully addressing this objective will requires in-depth exploration of the multitude of factors mediating risk of exposure that are affected by social dynamics at the international, national, community, familial and individual level. as a first step, we chose to start this endeavor simply, by comparing groups distinguished by different social determinants of human activity involving animals, e.g., gender, age, ethnic norms, livelihood systems, settlement patterns. the study is designed to facilitate such comparisons, for example, of different population groups (e.g., two ethnicities) living in the same location, thus having similar access to animals, or the same group in locations where access to animals is likely to differ (e.g., one ethnic group living in different settings). in addition, the design includes separate samples of men and women to assess the effect of gender on exposure and provides for subsamples of children likely to have different frequencies or types of exposure than adults. the instruments are designed to gather information on other social contrasts including, for example, religion, occupation, and education. the study uses a mixed-methods approach carried out in two phases: qualitative formative research and a quantitative survey. a mixed-methods approach is especially suitable for this research because it accommodates the need to standardize while recognizing the importance of context for the information gathering process. a generic protocol and instruments are adapted for each site. the first phase, formative research, involves collecting qualitative data that can provide an in-depth understanding of the humaneanimal interface, including the "how," "when," "where" and "why" of exposure. this information is also used to guide adaptation of the survey instrument to local conditions. the formative research draws on a variety of qualitative approaches: participatory rural appraisal (pra) methods (chambers, ) are employed to answer research questions where local knowledge is especially critical (e.g., seasonality of activities and animals, organization of physical space). projective techniques (wiehagen et al., ) are tools for uncovering and exploring underlying motivations or feelings that respondents might be unaware they have or might be unwilling to discuss openly (e.g., hunting protected wild animals). they use ambiguous images or descriptions of situations, on which participants may "project" their attitudes, feelings and opinions safely without divulging personal information. structured anthropologic methods (bernard, ) allow for systematic collection of data related to the cultural knowledge (e.g., taxonomies) held by the respondents (e.g., how a community categorizes animals into groups). the second phase of the human-animal exposure study is a random survey of individuals to quantify their exposure to animals as completely and as accurately as possible. it uses a generic protocol and instruments that are adapted for each site. the sample size for the survey should be calculated to allow for estimation of exposure parameters within desired confidence limits for each gender group; we routinely use ± %. the generic survey instrument is structured in modules related to the most common ways (activities and locations) people are exposed to animals. these correspond to three categories of proximate determinants: norms, livelihood and settlement patterns. finalizing locale-specific instruments is based on results of the formative research regarding the types, categorization, roles and uses of different animals in specific communities. (see below for discussion of the key factors considered in adapting the questionnaire for a specific site). if the formative research identifies activities or locations associated with human-animal contact that are not included in generic modules, the survey questionnaire is amended; in some cases entire modules may be developed and added. for instance, during the formative research phase in one setting we learned about use of animals and animal products for medicinal purposes and encounters with animals when gathering wood and non-timber products in the forest; questions about these potential contacts were included in the subsequent survey. currently available modules are listed in table . not all encounters between humans and animals are direct e or memorable. they can easily be overlooked or forgotten. to increase recall of events that may not be considered important, survey questions are supported with extensive, systematic probes. to ensure that survey data are as valid and reliable as possible, we carry out cognitive interviewing (willis, ) using the siteadapted survey instruments. this approach involves pretesting sections of the questionnaire to assess how people understand questions and process information in order to respond to them. cognitive interviewing helps to identify potential misunderstandings and questions that are especially hard for respondents to answer and determine if response categories make policies, regulations and enforcement of trade in animals and animal products, global travel, multinational agriculture and extractive industries, migration sense; this information is used to finalize the questionnaire before deployment. two key decisions in developing a study design were the range of animals and the parameters of exposure that the study should cover. types of animals the survey collects some information about exposure to all kinds of domestic and wild animals and more detailed information to quantify human exposure to wild animals particularly likely to carry zoonotic viruses e bats, rodents and nonhuman primates e as well as to poultry. this decision was based on current information about transmission of viral infections. non-human primates, bats, and rodents (including rats, mice, squirrels and porcupines) are mammals of particular interest. all are reservoirs or suspected reservoirs of infections that have caused important outbreaks of human disease: nonhuman primates for hiv (keele et al., ) ; bats for sars, nipah, hendra and as suspected reservoirs for ebola and marburg viruses (a. p. dobson, ; kuzmin et al., ) ; rodents for lassa fever virus and hantavirus (both confirmed) and as suspected reservoirs or important intermediate hosts for monkeypox (meerburg et al., ). in addition to these reservoir species, it is important to obtain some information about possible intermediate hosts e animals that may be infected and in turn infect humans. a wide range of wild animals can be intermediate hosts; for example, both nonhuman primates and antelopes can be infected with ebola and transmit the infection to hunters who find the carcasses (lahm et al., ) . domestic animals, including pets, and other animals that come in frequent contact with humans also have to be considered, as they have been shown to be intermediate hosts or carry viruses such as avian influenza (van kerkhove et al., ) , rabies (chomel et al., ) or rift valley fever (woods et al., ) . our study therefore accounts for human interactions with a wide variety of mammals, both wild and domestic. it also includes human interactions with domestic poultry and pigs, because of the contribution of influenza viruses from both birds and swine to influenza h n and the importance of h n (and recently h n ) as poultry diseases that can infect humans (d. j. alexander and brown, ) . parameters of exposure the survey assesses frequency and duration of exposure to animals and to a certain extent, proxies of "intensity" of exposure (e.g., contact involving oral fluid from an infected animal on intact human skin is probably less risky than being deeply bitten by an infected animal). it was not designed to directly measure risk because for many diseases too little is currently known for accurate quantification of risk (even, for example, about the amount of viruses present in viscera vs. muscle vs. blood vs. nasal excretions vs. feces vs. oral fluid, or about the persistence of virus in various organs after an animal's death or on different surfaces under different conditions). therefore, for the analysis, information about intensity is translated into weighted scales based on expert opinion. because language and cultural frameworks affect the validity of information gathered through surveys, the formative research is designed to elicit the information needed for local adaptation of the survey instrument. particular attention is paid to local names of animals and how people speak about encounters, time and locations. identification of animals one of the main goals of the formative phase of the research is to generate local animal dictionaries for use during the survey. we have found that there are usually no comprehensive lists of local animal names and that even those lists that are available do not include regional or local variations. ethnic groups vary in the specificity with which they recognize animals. recognition can sometimes serve as a proxy for exposure, as people tend to be more familiar with the animals they encounter most frequently. for instance, in thailand people were able to identify rats (a food source as well as a pest) with a great deal of specificity and were able to name several types of rats. in contrast, they did not use different names for different species of bats. during the formative research a concerted effort is made to identify local names and any areas of possible confusion by using an extensive array of animal photos and discussions about animals found in the community. one exercise uses probes focused around senses (e.g., what about animals you smelled? or animals you heard?) to improve recall. in thailand, when first asked to recall animals in the community (a question unlinked to senses), most people first mention animals they see. on being prompted for animals they "touch," new animals are recalled e mostly those that are cooked or cared for (such as fish, crab, cows, cats and dogs). another prompt, for animals people have observed "evidence of being around," has elicited reports of wild boar and bear (stool, foot print), pangolin and mongoose (holes), squirrels (bitten fruits and food), fox (howling), snake (skin and smell), cockroach (stools), and civet (stool and foot print). in thailand, the formative research generated a dictionary of about animal names just in the rodent, bat and primate animal orders and in lao pdr, dictionaries included names in those animal categories for hmong and for lao-tai. in addition to the dictionaries, naming conventions for animals are ascertained, enabling the identification of additional animals during the survey. for instance, pua is the generic name for bat in hmong; names for different types of bats modify this generic name (e.g., pua-lor and pua-sam-wa). whenever available, this kind of information allows researchers to determine the category of animal if they encounter a new animal during the fielding of the study. the questionnaire is structured such that if respondents do not spontaneously mention specific animals of interest (bats, nonhuman primates, or rodents), interviewers probe for them by local name (spontaneous and probed responses are coded differently). information obtained during the formative research phase is analyzed to determine how specific these probes should be. how people describe actions people vary in the way they talk about encounters. use of the wrong term may lead to miscommunication and collection of incomplete or inaccurate data. different terms may be used in slightly different situations; for example, among the lao-tai, people "hunt" [larr suud] for larger animals but "go looking for" [pai ha kni, pai xook suud] smaller animals. thus "rice field rat" is not a response obtained when "what do you hunt?" is asked. the formative phase of the study explores use of language to describe animal encounters. glossaries of key clusters of words are built, along with notes about the context of their use. for example, one such cluster is "slaughtering," "butchering," "cutting up," "preparing" e terms that can have implications for intensity of exposure since they are associated with how recently an animal has died and thus the amount and viability of pathogens that might be transferred. temporal variation to ensure that information about rare, as well as routine, encounters with animals is obtained and to account for seasonality, the survey documents human-animal contacts over the previous year. the single exception is information about hunting and eating animals. recall about eating is especially problematic because the activity is so routine. thus respondents are first asked about what animals have been hunted or eaten in the past four weeks, and then asked about the previous months. one portion of the formative research focuses on the rhythms of life in the community across the year to identify seasonal patterns of activities and encounters with certain animals. for example, formative research in lao pdr identified two seasons (rainy and dry) significant to the community. for activities identified as seasonal (e.g., application of fertilizer, hunting) probes for these seasons are used during the survey to aid recall of encounters with animals. such information is not only critical for understanding temporal patterns of risk of transmission; it may also be critical in the design of any strategies for the mitigation of such risk. spatial variation location is a key factor that determines the number and variety of animals to which humans are exposed. different groups identify key spaces differently. for example, space just outside a house may be considered "living space," equivalent to space inside the house, or may be considered part of "public space". one section of the formative study explores how people understand and talk about the spaces around them; the cognitive interviews include tests of questions involving specific locations. comparing two ethnic groups living in the same area is a good way to understand how socially-determined gender and age roles and norms affect different kinds of exposure to animals and thus potential risk. this section presents illustrative examples from lao pdr, where lao-tai and hmong ethnic groups living in the same location, with similar access to animals, were interviewed. the hmong are an ethnic minority in lao pdr and tend to be of lower socio-economic status compared to their dominant ethnic counterparts e the lao-tai. the hmong and lao-tai are culturally and linguistically distinct groups; for instance almost all hmong in our study practiced animist religion while a majority of the lao-tai were buddhists. the survey included men, women, boys and girls across both ethnic groups, with roughly half of each ageegender category drawn from each ethnic group. note that all difference between groups discussed in this paper were significant at p < . or below. a comparison of the consumption patterns of lao-tai and hmong highlights the importance of social factors in key exposures. we examined the steps involved, from hunting or purchasing through preparation and eating. practices associated with hunting offer opportunities for transmission: for example, hunters may be bitten or scratched by an infected animal, they may handle the carcasses and viscera of infected animals (whether killed or found dead) and get infected blood into wounds, or may have contact with animal feces. slaughtering and preparing (butchering and cutting up) wild animals, whether done by hunters, their family members or people who buy animals, can place people at risk of transmission through direct exposure to blood and internal organs as well as feces. finally, eating is an important source of potentially risky exposure, as ingestion of meat or blood from infected animals, especially raw or uncooked, or intake of other foods or liquids contaminated with viruses can cause disease. hunting is a common activity among both lao-tai and hmong, but is clearly a domain of men and boys; very few girls and women hunt animals other than rats/mice and other rodents (fig. ) . although the two ethnic groups live in the same area, there is a difference in the types of animals they report hunting e a proxy of their familiarity with these animals (see table ). while respondents from the two groups both report hunting six types of bats, the hmong report more types of nonhuman primates and squirrels while the lao-tai report more types of rats/mice. the animals hunted most often by both ethnic groups are rats/ mice and other rodents (squirrels and porcupines). rats/mice are eaten by nearly three quarters of hmong and lao-tai men, women, and children and more than half of adults and children also participate in preparing them. however, boys, especially hmong boys, are the group most likely to hunt, slaughter, prepare and eat them; more than three quarters of lao-tai and more than % of hmong boys reported hunting rats/mice in the last year. boys are also more likely than any other group to report being scratched and bitten by rats/ mice. about % of hmong and about % of lao-tai boys reported being scratched or bitten by rats/mice in the four weeks. however, it is worth noting that women and girls also hunt rats/mice. among the hmong, about % of girls reported hunting them. women and girls are more involved in slaughtering and preparing rats/mice than in hunting, and their involvement differs by ethnicity. among lao-tai, girls and women are the groups least likely to slaughter and girls are the least likely to prepare rats/mice; however even among girls, nearly % report preparing rats/mice in the last year. on the other hand, hmong girls slaughter animals at rates equal to men (and higher than women) and prepare them at higher rates than men. bats are another animal to which hmong and lao-tai boys are more exposed than others; more than % of boys from both groups reporting hunting bats compared to less than % of all other subgroups. bat-eating by adults is delineated along ethnic lines; both lao-tai men and women were more likely to eat bats in the last year than their hmong counterparts. reasons for this pattern are suggested by results of the formative study: the hmong noted that bats are primarily eaten only when there is less choice of alternative meats, as many people consider them to be dirty and smelly. there is a striking difference between ethnic groups in consumption of nonhuman primates. hmong were more likely to eat nonhuman primates, with more than % of hmong, but almost no lao-tai (< %), eating them in the last year. hmong men were also most likely to report hunting, slaughtering and preparing nonhuman primates. finally, consumption of raw meats varies by gender. both lao-tai and hmong participants in the qualitative research reported that eating raw meat and internal organs, and drinking blood from certain animals, including cows, pigs and squirrels, is considered a male activity. participants also stated that eating raw meat is not appropriate for those who are "weaker," including women and children. the survey confirmed this finding; men (both lao-tai and hmong) were three times as likely as women to consume raw animal products. the survey also showed some ethnic differences in patterns of raw meat consumption: hmong men and boys were more likely than their lao-tai counterparts to consume raw meats. as can be seen from these differentials, social factors clearly influence the possible risk of transmission associated with consumption. both lao-tai and hmong hunt, but different subgroups have different risks as a result of hunting: males in both ethnic groups are at higher risk from hunting any animal (compared to females); boys in both ethnic groups (compared to any other groups assessed) are at higher risk from hunting bats and rats; and hmong men are at higher risk from hunting nonhuman primates. women and girls, on the other hand are exposed to rats by being involved in preparing them. finally, social factors also determine who is at risk from eating different meats: eating rats is an equal source of exposure for adults and children in both ethnic groups; the hmong are more exposed to nonhuman primates and the lao-tai to bats as a result of eating; and men are more intensely exposed as they are more likely to eat raw meat compared to women. raising animals is another area where the influence of social factors on exposure, and therefore the risk of transmission, is evident. domestic animals are raised by nearly everyone in the study area: about % of both hmong and lao-tai reported raising poultry in the last year, and more than half of both hmong and lao-tai reported raising pigs, cows, cats and dogs. risk of transmission from raising animals can come from a number of sources, including sharing living quarters with the animals. more than % of respondents in both ethnic groups reported that poultry come into the house. there is a difference between the two groups in pigs in and around the house: nearly % of lao-tai reported pigs in or around the house, while fewer than % hmong did so. the formative research also shows that the lao-tai build their houses on stilts and keep pigs and other domestic animals under the houses. the study draws attention to a specific risk for children in both communities. among the hmong, more children than adults, especially boys, reported being bitten or scratched by domestic animals in the past year; e.g., nearly one third of hmong boys reported being scratched by poultry compared to < % of hmong men. while this may stem from inexperience when caring for domestic animals, the qualitative portion of the study identified other activities that might place children at particular risk, including playing with chickens and organizing cockfights. children were also reported to keep squirrels and small monkeys as pets and to capture and use bats as playthings. another area with clear differences along ethnic lines is the use of animal feces for agriculture. both groups, but more lao-tai than hmong, use feces from poultry, cows and pigs as fertilizer. in contrast, more hmong than lao-tai use bat guano as fertilizer. the formative study showed a difference in the division of labor among men and women and children in the acquisition and use of guano: men are responsible for collecting bat guano from caves once or twice a year, and women or children are responsible for applying the guano to fields and gardens once or twice a month. while the study highlighted nearly universal exposure to domestic animals in these communities, it also shows a specific risk for hmong boys during care of or playing with poultry (they reported being scratched and bitten more) and a possibly elevated risk for lao-tai households whose pigs may come indoors. finally, exposure to feces used as fertilizer has been shown to vary by ethnic, gender and age groups; this may translate into different kinds of risks for different groups in contact with the same source of virus (feces) but from different animals (poultry and pigs vs. bats) and in different activities/locations (obtaining from around households vs. obtaining in caves vs. applying on fields). insight about the large-scale drivers of zoonotic disease emergence e land use patterns, increasing human population and global movement of people and goods e is useful for informing national and global policies with regards to human development activities. given current realities, a more in-depth understanding of the specific ("micro") aspects of the human-animal interface that can result in spillover events would complement current efforts for planning prevention or mitigation strategies. the expanded one health model asserts that different people living in the same location, affected by the same large-scale drivers, may be at different risk of spillover because of the social factors that influence the types of activities they engage in. who is at risk and how they are at risk of spillover are determined by social factors, such as those affecting communities within societies and families and individuals within communities (e.g., gender, age, family structures, ses, occupation, community resources), norms with regards to different animals (e.g., food taboos or preferences), settlement patterns that can limit or increase contact with certain animals (e.g. how homes are constructed) and livelihood systems that may involve direct or indirect contact with animals (e.g., whether or not people rely on subsistence or commercial hunting). information about these factors can be used to develop targeted interventions to reduce risk. as illustrated by the development of the human-animal exposure study, the expanded model can guide a more in-depth exploration of the human-animal interface. information generated from such studies can be critical for identifying specific groups that are at high risk of spillover and assessing possible routes of transmission. for instance, in lao pdr, where a human-animal exposure study informed by the expanded model was implemented with different groups living in the same general location, the unexpected finding that children were more exposed than adults to some animals suggests that children might warrant a special look if there is a concern about transmission of viruses from bats and rats. on the other hand, if the concern is about viruses from nonhuman primates, a focus on hmong men might be very important. in-depth study of the human-animal interface at the local level not only provides information about specific groups at risk of transmission, but also highlights the activities that put them at risk. for instance, in the communities described in this paper, hunting and ingestion of key animals previously implicated in outbreaks (rodents, bats and nonhuman primates) is common: men and boys hunt, and different sub-groups of the communities eat these animals, albeit at different rates. in addition, raising animals such as chickens and pigs, which are known to be intermediary hosts, is a universal activity. depending on the specific animal, virus or route of transmission, interventions might be able to target specific groups involved in different activities. for example, since men and boys are the groups most involved in hunting, they could be the specific focus of general programs to promote safer hunting practices, but if exposure to rats/mice were a particular concern, the intervention would need to include women and girls as well. general interventions addressing butchering and preparation of animals should involve all age/gender groups. the proposed expanded one health model aims to focus attention on the local level factors that determine probability of disease emergence in conjunction with large-scale drivers. by understanding the complex interactions of these factors, the added value of the expanded model is that community or individual level behavior change interventions can be designed to complement policy-level strategies. the human-animal exposure study described in this paper does not attempt to explore the entirety of the complex social dynamics that can determine the location, time and intensity of exposure. as a first step, we focused on demonstrating that the most basic socially determined factors affect exposure, and did not consider how community and family dynamics or governance and politics at the national and international levels play a role. different types of studies would be needed to address and/or incorporate those factors. we hope that the current study provides a solid start to the conversation about the need to embed social science approaches in explorations of human and animal health and opens the door to further in-depth studies exploring how social dynamics affect risk of spillover. other groups are encouraged to use the model as a basis for developing studies to explore the complex interaction of various social and environmental factors that result in disease emergence. some of the questions to be explored might include: how does urbanization and exposure to "international" norms affect attitudes and patterns of consumption of different types of wildlife meat? what effects do various approaches to communitybased natural resource management in different types of communities have on the frequency and type of interaction with domestic and wild animals? how do national policies regarding universal primary education and their implementation at the local level affect community and family expectations, their socialization of children and different family members' relation with domestic and wild animals? answering these questions will involve different types of methods. a cross-sectional survey of a large group of individuals such as reported here is appropriate for capturing an overall snapshot of the human-animal interface, including all the animal species people could come interact with as well as all the major activities and locations associated with interactions. other approaches would be optimal for more focused studies targeting a specific group of animals (e.g. primates) or specific activities (e.g. hunting). for instance, exposure could be documented by intense observation of individuals over long periods of time or by asking people to keep diaries of specific activities such as hunting or eating. more in-depth qualitative or ethnographic studies can help tease out the social and cultural influences shaping specific types of interactions with animals. it is important, however, to remember that all these methods bring their own set of methodological and ethical challenges that would need to be carefully considered, similar to the process described in this paper for the cross-sectional study. finally, it is important to note that the expanded one health model does not address the factors that determine whether or not a spillover evolves into a full-scale outbreak e a critical topic worthy of immediate attention. recent zoonoses caused by influenza a viruses human behavior influences infectious disease emergence at the humaneanimal interface research methods in anthropology poor housing quality increases risk of rodent infestation and lassa fever in refugee camps of sierra leone urbanization and the ecology of wildlife diseases economic and geographic drivers of wildlife consumption in rural africa the origins and practice of participatory rural appraisal wildlife, exotic 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the emergence and transmission of infectious diseases highly pathogenic avian influenza (h n ): pathways of exposure at the animal-human interface, a systematic review commerson's leaf-nosed bat (hipposideros commersoni) is the likely reservoir of shimoni bat virus morbidity and mortality of wild animals in relation to outbreaks of ebola haemorrhagic fever in gabon socioeconomic and environmental risk factors for urban rodent infestation in sao paulo rodent-borne diseases and their risks for public health food taboos: their origins and purposes prediction and prevention of the next pandemic zoonosis casecontrol study of risk factors for avian influenza a (h n ) disease, hong kong unhealthy landscapes: policy recommendations on land use change and infectious disease emergence factors explaining the abundance of rodents in the city of luang prabang, lao pdr, as revealed by field and household surveys the handbook of health behavior change ecological sources of zoonotic diseases microbial threats to health: emergence, detection, and response risk factors for human disease emergence one health™. retrieved from october food rules: hunting, sharing, and tabooing game in papua new guinea h n avian influenza: timeline of major events applying projective techniques to formative research in health communication development cognitive interviewing: a tool for improving questionnaire design an outbreak of rift valley fever in northeastern kenya we thank zo rambeloson and kanokwan suwannarong who implemented the research; they and sidney schuler, lonna shafritz, renata seidel, david sisanath, mario chen and tim mastro provided helpful comments. we also express sincere appreciation the social science and medicine anonymous reviewers for their thoughtful suggestions. support for this study was provided by fhi with funds from usaid cooperative agreement ghn-a- - - - ; this study was made possible by the generous support of the american people through the united states agency for international development (usaid). the contents are the responsibility of the authors and do not necessarily reflect the views of fhi , usaid or the united states government. the funder had no involvement in study design, collection, analysis, interpretation of data, writing or in the decision to submit it for publication. key: cord- -vbn vwnn authors: mansoor, marium; najam, shireen; nadeem, tania; allaudin, sunita; moochhala, mariya; asad, nargis title: integrating mental health in covid- crisis: staff mental health referral pathway date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: vbn vwnn nan in february , the first case of covid- was detected in pakistan (shahid, ) , a lower middle income country with scarce resources. as the number of confirmed covid- cases and fatalities increased, there was an influx of patients for assessment and treatment at akuh, which is a quaternary care teaching hospital. this is known to lead to immense pressure on all health care workers (hcw) due to increased workload, anxiety regarding acquiring infection or passing it on to a family member and fears of death (chen et al., ; adams &walls, ) ,which also affects their attention and decision-making ability, and overall wellbeing (maunder et al., ) . unfortunately, the psychological ramifications due to an outbreak's direct and indirect effects remain widely unaddressed (chan et al., ; tandon, ) . anticipating the mental health fallout, the department of psychiatry (dop) initiated a pathway to provide rapid, confidential and accessible help to all hcws during this crisis. the dop in liaison with human resources department formulated an evidence based pathway (chen et al., ; liu, ; zhang et al., ) to address mental health needs of hcws. the service was free of cost and built on the existing sparse resources (ahmad, ) , with regular review of process in weekly meetings. the purpose of this paper is to describe the structure of this pathway so it can be replicated in other institutes, especially those working with limited mental health personnel. the hcws of akuh were provided with a hotline number that could be used during work hours, to help with covid- related anxiety (refer figure ). the first point of contact was the assistant head nurse of the psychiatry department. guidance and supervision was provided to her by members of faculty, regarding interviewing staff members about their anxiety. screening was done using a brief questionnaire. she was also trained in providing information on basic relaxation techniques and a cbt outline for mapping their thoughts.  for mild problems: hcws were encouraged to use self-help, structured routine, and web based resources will also be shared. on follow up call the hcws showing improvement were encouraged to continue advice, in case of no improvement; specialist appointment was scheduled.  for severe problems: hcws were given urgent appointments on next working day in faculty tele-psychiatric clinics dedicated for hcws. faculty members decided the aftercare as per their evaluation. the record of the evaluation was maintained in a separate folder by the dop to ensure staff confidentiality. this was a free of cost service and notes were kept in a separate folder. there are three main challenges that we might face. ) resistance to seek help and fear of stigma and confidentiality of hcws. to address this, the record of the evaluation is maintained in a separate folder in lock and key by the dop. ) some hcws are utilizing the pathway for pre-existing mental health needs which is not our primary objectives. such hcws are redirected to clinics as usual. our staff mental health pathway was initiated in a crisis situation, with the expectation of optimistic staff outcomes (bronkhorst eet al., ) amongst the uncertainty. we aspire to minimize the invisible burden of mental health illnesses on our hcws, support and built on their capabilities towards a pathway of minimal employee under-performance and absenteeism (harnois & gabriel, ) . the aforementioned pathway can be contextualized to resource limited settings in pakistan and elsewhere according to the organizations' respective service structure. j o u r n a l p r e -p r o o f supporting the health care workforce during the covid- global epidemic shortage of psychiatrists a problem in pakistan organizational climate and employee mental health outcomes: a systematic review of studies in health care organizations. health care manage rev the psychosocial and interpersonal impact of the sars epidemic on chinese health professionals: implications for epidemics, including ebola. the psychosocial aspects of a deadly epidemic mental health care for medical staff in china during the covid- outbreak mental health and work: impact, issues and good practices online mental health services in china during the covid- outbreak applying the lessons of sars to pandemic influenza two coronavirus cases confirmed in pakistan the covid- pandemic, personal reflections on editorial responsibility recommended psychological crisis intervention response to the novel coronavirus pneumonia outbreak in china: a model of west china hospital financial disclosure: none acknowledgement: none key: cord- -rxdw c authors: sawyer, alexandra; ayers, susan; field, andy p. title: posttraumatic growth and adjustment among individuals with cancer or hiv/aids: a meta-analysis date: - - journal: clin psychol rev doi: . /j.cpr. . . sha: doc_id: cord_uid: rxdw c there is increasing research on posttraumatic growth after life-threatening illnesses such as cancer and hiv/aids, although it is unclear whether growth confers any psychological or physical benefits in such samples. consequently, this meta-analysis explored the relationship between posttraumatic growth and psychological and physical wellbeing in adults diagnosed with cancer or hiv/aids and examined potential moderators of these relationships. analysis of studies (n = ) of posttraumatic growth after cancer or hiv/aids revealed that growth was related to increased positive mental health, reduced negative mental health and better subjective physical health. moderators of these relationships included time since the event, age, ethnicity, and type of negative mental health outcome. it is hoped that this synthesis will encourage further examination of the potentially complex relationship between posttraumatic growth and adjustment in individuals living with life-threatening medical conditions. parallel other traumatic stressors in many ways. the diagnosis may be sudden and unexpected, the disease and treatment may pose threats to one's life, and the experience may evoke intense emotional responses of fear and helplessness. at the same time living with a life-threatening illness is not an acute, singular stressful experience, but rather a series of unfolding threats and stressors (cordova, ) . cumulatively, these experiences can constitute a traumatic stressor for many individuals with cancer or hiv/aids. experiencing a lifethreatening illness was first recognised as an event that could precipitate posttraumatic stress disorder (ptsd) in the dsm-iv (american psychiatric association [apa], ) . rates of ptsd in cancer patients range from % to % (kangas, henry, & bryant, ) and in hiv/aids patients from % to % (botha, ; kelly et al., ; martinez, israelski, walker, & koopman, ) . over the past decade there has been an important shift in emphasis of research from a nearly exclusive focus on the negative aftermath of such events to consideration of possible positive outcomes (linley, ) . researchers have used a number of different terms to describe individuals' reports of benefits in the face of adversity, including posttraumatic growth, adversarial growth, benefit-finding, and thriving. throughout this paper tedeschi, park, and term posttraumatic growth (ptg) will be used to describe a positive change in one's previous level of functioning as a result of the struggle with highly challenging life circumstances. this term differs from resilience, optimism, hardiness, which describe individuals who have adjusted successfully despite adversity (o'leary & ickovics, ) , whereas individuals experiencing ptg are transformed by their struggle with adversity. a rapidly increasing literature now testifies to the prevalence of positive life changes and personal growth following cancer and hiv/ aids. equally high rates of positive changes have been reported across both illnesses. between % and % of people living with hiv/aids have been shown to report positive changes since diagnosis (milam, (milam, , a siegel & schrimshaw, ) . likewise, data suggest that between % and % of cancer survivors also report positive changes (collins, taylor, & skokan, ; fromm, andrykowski, & hunt, ; petrie, buick, weinman, & booth, ; rieker, edbril, & garnick, ) . within the general ptg literature three common categories of growth outcomes have been identified (joseph & linley, ; tedeschi et al., ) . first, individuals often report that their relationships are enhanced in some way. for example many individuals with cancer or hiv/aids require practical and emotional support, and positive interpersonal experiences may strengthen a person's appreciation of some relationships. second, people change their views of themselves in some way. for example patients may develop a greater sense of personal resilience and strength, an acceptance of their vulnerabilities and limitations, which are typified by a heightened awareness of their own mortality and the fragility of life. third, there are often reports of changes in life philosophy. for example people diagnosed with cancer or hiv/aids are faced with the concern that their disease might progress and shorten their life and these concerns may lead to a shift in priorities and values, and to a different appreciation and approach to day-to-day life. together these positive changes in psychological well-being can lead to a whole new way of living. finally certain changes have been identified specific to individuals facing a serious illness. a recent focus of the ptg research has been the relationship between ptg and health behaviours (milam, ; milam, ritt-olsen, & unger, ) . luszczynska, sarkar and knoll ( ) found that ptg significantly predicted adherence to antiretroviral therapy in individuals diagnosed with hiv. furthermore, women with breast cancer have described making positive changes in health related behaviours and engaging in more careful cancer surveillance as a result of their experience (sears, stanton, & danoff-burg, ) . studies that compare ptg in cancer and hiv/aids patients suggest that growth is experienced in the same multidimensional manner across both illnesses (lechner & weaver, ). therefore, alongside psychological, interpersonal, and life orientation changes, positive changes in health behaviours may also occur following a life-threatening illness diagnosis. several models have now been proposed regarding the occurrence of ptg. the three most detailed models to date include tedeschi and calhoun's ( calhoun's ( , ) functional descriptive model, organismic valuing theory and christopher's ( ) biopsychosocial-evolutionary theory. although with some variation, most models hypothesize that the experience of a highly stressful or traumatic event violates an individual's basic beliefs about the self and the world and that some type of meaning making or cognitive processing to rebuild these beliefs and goals occurs, resulting in perceptions that one has grown through the process (horowitz, ; janoff-bulman, ; tedeschi & calhoun, ) . although offering different levels of explanation at both the social cognitive and biological evolutionary levels, they are complimentary in that they are underpinned by the notion that people are intrinsically motivated towards growth (joseph & linley, ) . an important issue to be addressed in the literature is whether ptg following the diagnosis of a life-threatening illness is associated with psychological and physical benefits (zoellner & maercker, ) . however, the current literature is unclear. for example some studies report there is no significant relationship between ptg and distress (cordova, cunningham, carlson, & andryowski, ; schulz & mohamed, ) , and other studies suggest distress and ptg can co-exist (tomich & helgeson, ) . for example barakat, alderfer, and kazak ( ) found that ptg and posttraumatic stress symptoms were positively correlated in adolescent survivors of cancer. however, other studies have reported an inverse relationship between measures of ptg and psychological distress (linley & joseph, ; updegraff, taylor, kemeny, & wyatt, ; urcuyo, boyers, carver, & antoni, ) . therefore, it remains to be established whether the experience of ptg in relation to a life-threatening illness confers any benefit in terms of psychological or physical health. given the discrepant findings on this relationship a systematic integration of the literature is needed, and a meta-analysis is an ideal tool to do this. a previous meta-analysis conducted by helgeson, reynolds, and tomich ( ) investigated the association between ptg and adjustment after a wide range of events such as sexual assault, natural disaster, bereavement, childhood abuse and illness. they found that ptg was related to more positive affect and less depression, but also to more intrusive thoughts about the event. ptg was unrelated to anxiety, distress, quality of life and subjective physical health. as such the aim of the current paper is to present a meta-analysis of the existing literature that will aim to objectively summarize ptg and its relation to adjustment in individuals living with a life threatening illness (cancer or hiv/ aids) and to examine potential moderators of this relationship. one possible explanation for the inconsistency between ptg and adjustment is that the relationship is moderated by other variables. therefore five possible moderators will be examined that might attenuate or accentuate the growth-adjustment relationship. these were chosen because they are commonly assessed within the literature, and have prior empirical and theoretical foundations. the first variable that might moderate the relationship between ptg and adjustment is the length of time since the diagnosis. research and theory suggest that ptg is unlikely to occur shortly after the critical event, but rather takes time to occur and is more likely to be reported in hindsight tedeschi & calhoun, . therefore it is hypothesized that ptg is associated with positive adjustment when a longer time since the health event has elapsed. three characteristics of the sample will also be examined as moderators: age, gender, and ethnicity. past research has indicated that women (bellizzi, ; milam, ) , younger participants linley & joseph, ; milam, ; widows, jacobson, booth-jones, & fields, ) , and ethnic minorities are more likely to report ptg. however, it is not clear if and how these individual differences differentially relate to ptg and adjustment . therefore no specific predictions about directionality regarding how these variables might moderate the growth-adjustment relationship will be made. it is also possible that the quality of the study might moderate the relationship between growth and health. for example studies that use a valid measure of growth should reflect actual ptg, and distinguish from other processes such as self-enhancement, positive illusion, and "pseudogrowth" (lechner & antoni, ; park & lechner, ) . less validated measures may fail to capture ptg, and therefore account for some of the variation in the research. through examination of these moderators it is hoped that the meta-analysis will identify subgroups of adults whose experience of ptg is likely to be positively or negatively related to mental and physical health. in summary, the purpose of the present study is two-fold. primarily it is concerned with estimating the overall effect size of the relationship between ptg following a life threatening illness (cancer or hiv/aids) and various indicators of adjustment. secondly, this analysis hopes to identify the variability amongst studies and explore potential moderators of the growth and adjustment relationship. it is hoped that such a review of the extant literature will lead to an enhanced understanding of the impact of ptg on the adjustment process in individuals living with life-threatening illnesses. a systematic search was conducted to identify studies of ptg in individuals following cancer or hiv/aids. the primary search method for the selection of studies was a review of the psychological and medical literature using the following computerized databases up to october : medline, psycharticles, psychinfo, pubmed, and web of science. relevant key words were used to search for articles within these databases. search terms included key words related to ptg: posttraumatic growth, post-traumatic growth, benefit finding, stress related growth and adversarial growth. these terms were crossed with the following health-related key terms: health, illness, disease, life-threatening, chronic, medical, terminal, cancer, hiv, aids. additional studies were located through the inspection of the reference sections of obtained papers and reviews. relevant journals were also manually searched to locate papers that may not have been identified in the databases. these journals were: psycho-oncology, psychology and health, journal of traumatic stress, british journal of health psychology and journal of consulting and clinical psychology. in addition, active researchers in the field of psychological growth in health samples were contacted to ask for recent papers in the field and for unpublished research to reduce the effect of publication bias. a search of abstracts from relevant conferences was also conducted to locate additional unpublished work in the area. however, no unpublished studies were retrieved. this literature search yielded a preliminary database of published papers. these papers were examined to determine eligibility for inclusion in the meta-analysis. studies had to meet eight criteria for inclusion. first, studies were included only if the sample were adults aged or over. this decision was made because the current literature is unclear whether children or adolescents differentially experience ptg in comparison to adults (ickovics, meade, et al., ; ickovics, milan, et al., ; milam et al., ) , and also only a small number of studies have explored ptg in children and adolescents following illness (too few to include adult vs. child as a moderator variable). this resulted in the exclusion of nine studies. second, the studies had to use a quantitative measure of ptg, which was assessed in relation to a measure of positive psychological adjustment, negative psychological adjustment or physical health. studies that included a purely qualitative assessment of ptg, or papers that were reviews of the literature were excluded from the analysis. this resulted in the exclusion of studies. third, ptg must be measured in cancer or hiv/ aids patients. this criterion resulted in the exclusion of studies. fourth, intervention studies were excluded from the analysis unless they measured ptg at baseline prior to manipulation and effect sizes could be extracted. this resulted in the exclusion of studies. fifth, controlled comparison studies that did not report relevant data for the patient sample were excluded. this resulted in the exclusion of nine studies. longitudinal studies which measured ptg at different time points to adjustment measures were excluded. however, when longitudinal studies reported cross-sectional relationships these were included in the analysis. this resulted in the exclusion of seven studies. studies needed to include the relevant effect sizes (namely the correlation coefficient r) or sufficient statistical information that could be used to compute this statistic. authors of papers with unclear statistical information were contacted to enquire about further information and if this was unable to be provided these papers were excluded from the analysis. only two papers were excluded as a result of this criterion. finally, the authors of five non-english articles were contacted for copies of their papers but these were not provided. of the articles yielded by the literature search studies met all of the requirements for inclusion and were therefore used in the metaanalysis. studies included in the meta-analysis are identified with an asterisk in the reference section and a detailed list of the studies is provided in table . from these papers a number of variables were extracted for analysis: i) sample size, ii) sex composition, iii) ethnicity, iv) mean age, v) time since event, vi) health event vii) adjustment outcome, and viii) effect sizes for these relationships. the methodological quality of each study was also assessed based on a checklist developed by mirza and jenkins ( ) . the five criteria that were assessed were: ) clear study aims, ) sample representative of population, ) clear inclusion and exclusion criteria, ) validated measure of ptg, and ) appropriate statistical analysis. the studies were then given a total score of quality with the highest possible being eight ( = yes, = no). table displays the quality scores for each individual study. quality scores ranged from - ; however most studies were of good quality with over % of studies scoring or more. as expected, the concept of adjustment was operationally defined in a number of ways across individual studies. in our analysis measures were combined and a separate analysis was conducted for positive psychological adjustment, negative psychological adjustment and subjective physical health. psychological adjustment was defined in this paper as the psychological outcome, either positive or negative, following illness. specific adjustment measures associated with each adjustment outcome were also examined as moderators to explore how they might explain variability within the growth-adjustment relationship. these adjustment measures were coded as follows: a) positive psychological adjustment was coded either as psychological health (e.g. positive affect, mental health) or general well-being (e.g. life satisfaction), b) negative psychological adjustment was coded as specific symptoms (e.g. depression, anxiety, ptsd) or general distress, and c) subjective physical health was coded as either general physical health, physical symptoms, or functional ability. to examine the role of possible moderators in the growthadjustment relationship, the following information in each paper was coded and used in the analysis as follows: (i) time since diagnosis was examined as a continuous moderator by using the mean time in months, (ii) sample gender composition was examined as continuous variable coded as percentage of female participants, (iii) sample age was examined as a continuous moderator by using the mean time in years, (iv) it was decided to code ethnicity as a categorical variable, either as b % white or ≥ % white, as this strategy minimized data exclusion, and (v) the methodological quality of each study was examined as a continuous moderator. all analyses in this paper were carried out on spss (version ) using syntax specified in field and gillett (in press) . a separate metaanalysis was carried out for each adjustment outcome. in the present study the correlation coefficient (r) was chosen as the effect size estimate for a number of reasons. first, this was a common metric for which the greatest number of effect sizes could be reported or converted; second, it is easily computed from either chi-square, t, f, and d; and third it is readily interpretable (rosenthal & dimatteo, ) . a number of papers reported correlation coefficients only for the subscales of ptg. therefore to guarantee the independence assumption among effect sizes the coefficients were averaged to produce a single effect size associated with overall ptg. when a study did not report the effect size or probability value but stated only the relationship was nonsignificant an effect size of zero was assigned to that relationship. this is a conservative strategy because it generally underestimates the true magnitude of effect sizes (durlak & lipsey, ; rosenthal, ) . however, this approach is preferable to excluding nonsignificant results from the meta-analysis, because this would result in an overestimation of combined effect sizes (rosenthal, ) . the authors of these papers were contacted for further information and there was only one study where an effect size of zero assumed. in meta-analysis two common statistical procedures are used: fixedand random-effect models (hedges, ; hedges & vevea, ; hunter & schmidt, ) . real social science data have been shown to contain variability in effect sizes as the norm, which indicates variable population parameters (field, ; field, ; field & gillet, in press; hunter & schmidt, ) . for this reason, and so the results can be generalized beyond the studies included in the meta-analysis, a random effects model was carried out. hedges and vevea's ( ) method was applied using fisher-transformed correlation coefficients with results reported after the back transformation to the pearson product-moment correlation coefficient (see field, ; overton, ) . using this method, each effect size is weighted by a value reflecting both the within study variance ( /n − for correlation coefficients in which n is the sample size) and the between study variance (τ ). the exact weight function for each effect size is w * i = n i − +τ − (see field & gillet, in press for a guide to using hedges and vevea's method). moderator analyses were conducted also using a random-effects general linear model in which each z-transformed effect size can be predicted from the transformed moderator effect (represented by regression coefficient, β). the moderator effect, β, is estimated using generalised least squared (gls). in both the main analysis and moderator analyses, between study variance was estimated noniteratively (e.g. dersimonian & laird, ) . for a technical overview of the gls moderator analysis that we employed see overton ( ) or field and gillet (in press). in any meta-analysis publication bias is a concern. this bias refers to the tendency that the decision to publish a paper is determined by the results of the study (begg, ) . for example studies with nonsignificant findings are less likely to be published than those with significant outcomes, which could result in a positive bias within the literature. there are different approaches to estimating publication bias: rosenthal's ( ) fail-safe n, funnel plots and sensitivity analysis. the fail safe n estimates the number of unpublished, nonsignificant studies that would have to exist for the obtained probability value of the population effect size estimate to be rendered nonsignificant. this measure is problematic because its emphasis is on significance testing the population effect size rather than estimating the population effect size itself. therefore, we have chosen to report table stem and leaf plot of effect sizes for negative mental health (rs). . , , , . , , , , , , , , . , , , , , , , , , , , , , −. , , , , , , , −. , , , , , , , , , , , , −. , , , , , , , −. , , , −. , , measures that specifically address bias in the population effect size estimate. first, we produce funnel plots of the effect found in each study against the standard error (light & pillemer, ). an unbiased sample will show a cloud of data points that is symmetric around the population effect size and has the shape of a funnel (reflecting greater variability in effect sizes from studies with small sample sizes/less precision). second, we performed a sensitivity analysis, which is a method that uses weights to model the process through which the likelihood of a study being published varies (usually based on a criterion such as the significance of a study). we applied the methods proposed by vevea and woods ( ) because they can be applied to relatively small samples of studies such as we have. there were studies included in the meta-analysis; with a total of participants. sample sizes from individual studies ranged from to . . % of the studies focused on individuals with a cancer diagnosis and . % included individuals with a hiv/aids diagnosis. length of time since treatment/diagnosis varied and ranged from to months (m= . , sd= . ). mean age of the sample was . (sd= . ). of the studies that provided information on ethnicity, the majority (n= ) included samples predominantly composed of white participants. tables - graphically represent the effect sizes included in each adjustment meta-analysis by means of a stem and leaf plot. the stem identifies the first digit of an effect size and the leaf identifies the final digit of an effect size. for positive mental health (table ) , the bulk of effect sizes were in the range of to . , but the range was quite wide (−. to . ) suggesting the influence of moderator variables. for negative mental health (table ) , the distribution of effect sizes is relatively symmetrical and is centered around to −. . again, the range of effect sizes was quite large (−. to . ) suggesting that moderator variables might usefully explain some of this variability. finally, for physical health (table ) the effect size distribution looks skewed and is centered around to −. . three studies appeared to have relatively large positive effect sizes that were inconsistent with the bulk of studies. table shows the individual meta-analyses for each adjustment outcome. ptg was significantly related to higher levels of positive psychological adjustment (ptg explained . % of the variance), lower levels of negative psychological adjustment (ptg explained only . % of the variance), and higher reported levels of physical health (ptg explained . % of the variance). the results suggest considerable variation in effect sizes for the three adjustment outcomes, and it is therefore important to examine factors that moderate these relationships. the funnel plots shown in figs. - suggest publication bias might be present in the data, as indicated by the non-funnel like and asymmetric distribution of data points around the estimated mean, typical of biased data sets. in particular, for positive mental health ( fig. ) and physical health (fig. ) , the data cloud is relatively sparse for small studies (the bottom part of the figure). this pattern is indicative of one-tailed publication bias (vevea & woods, ) . for negative mental health (fig. ) the cloud is a little sparse around zero for small studies, which indicates two-tailed publication bias (vevea & woods, ) . we calculated several publication-bias corrected estimates based on our interpretation of the funnel plots of the overall population effect sizes on positive mental health, negative mental health and physical health. we used vevea and woods ' ( ) weight function model of publication bias to calculate population effect size estimates under different selection bias scenarios. based on the funnel plots, for positive mental health and physical health we assumed moderate (mot) or severe (sot) one-tailed selection bias, and for negative mental health we assumed moderate (mtt) and severe (stt) two-tailed selection bias. the values corrected for selection bias were as follows: for positive mental adjustment, the original population estimate of . was reduced to . (mot), −. (sot); for negative mental adjustment, the original estimate of −. became −. (mtt) and −. (stt); for physical health the original estimate of . became . (mot), −. (sot). as such, the estimate of population effect size for negative mental health was unaffected by publication bias. if we assume moderate publication bias, then estimates for positive mental health and physical health were slightly reduced, but if severe publication bias is assumed then the estimates change quite dramatically. as such, our conclusions come with the caveat that if severe publication bias was, in reality, present in the literature then our conclusions would be quite different for positive mental health and physical health outcomes. five moderators that might explain significant amounts of effect size variation for each adjustment outcome were examined. subcategories of each adjustment outcome were also initially explored as moderators. categories of positive psychological adjustment did not significantly moderate the relationship between ptg and positive mental health (p n . ). time emerged as a significant moderator of positive psychological adjustment (β = . , p b . ), implying the longer the time since the event, the stronger the relationship between ptg and positive mental health. the age of the sample emerged as a significant moderator (β = −. , p b . ), indicating that samples with younger participants, showed a stronger relationship between ptg and positive adjustment. ethnicity also moderated the relationship between ptg and positive mental health, χ ( ) = . , p b . , indicating that samples comprised of more than % non-white participants demonstrated a stronger relationship between ptg and positive psychological adjustment. gender (β = . , p n . ) and quality (β = . , p n . ) did not significantly moderate the relationship between ptg and positive psychological adjustment. categories of negative mental health moderated the relationship between ptg and negative psychological adjustment. dummy coding revealed that ptsd symptoms had a stronger negative relationship with ptg in comparison to depression (χ ( ) = . , p b . ), but not in comparison to anxiety (χ ( ) = . , p n . ) and general distress (χ ( ) = . , p n . ). time since the health event, measured in months, moderated negative mental health (β = −. , p b . ), indicating the shorter the time since the event, the stronger the relationship between ptg and negative adjustment. ethnicity was also a significant moderator, χ ( ) = . , p b . , indicating that samples with more than a % white composition demonstrated a stronger negative relationship between ptg and negative adjustment. age also appeared as a moderator (β = . , p b . ), indicating that samples with older participants demonstrated a stronger negative relationship between ptg and negative adjustment. quality of the study (β = . , p n . ) and participant's gender (β = . , p n . ) did not moderate the relationship between growth and negative mental health. categories of physical health did not significantly moderate the relationship between ptg and physical health (p n . ). ethnicity moderated the relationship between ptg and physical health (χ ( )= . , pb . ), indicating that samples comprised of more than % nonwhite participants demonstrated a stronger relationship between ptg and physical health. furthermore, time (β=. , pn . ), gender (β= −. , pn . ), age (β=. , pn . ), and study quality (β=−. , p=. ) did not significantly moderate the relationship between ptg and physical health. this meta-analytic review summarized the findings from studies examining the association between ptg following cancer or hiv/aids and positive psychological adjustment, negative psychological adjustment, and subjective physical health. despite variability in effect sizes this analysis demonstrated a small positive relationship between ptg and positive mental health. therefore, individuals who perceive ptg following cancer or hiv/aids also report enhanced psychological well-being. furthermore, a small negative relationship was found between ptg and negative mental health. individuals who perceive ptg following cancer or hiv/aids also report reduced symptoms of negative mental health. finally, ptg displayed a small positive relationship with measures of subjective physical health, implying that ptg may also confer some physical benefit. these findings suggest that ptg is associated with positive adaptive consequences, and is therefore an important construct to be studied in clinical and health research. an additional aim of the study was to examine factors that might moderate the relationship between ptg and adjustment, and therefore provide further insight by accounting for variability in effect sizes reported previously. study quality and gender were the only variables that did not moderate the relationship between ptg and outcomes. therefore the implications of these findings are that studies of differing quality do not account for differences in the growth-adjustment relationship and that there are no significant differences between men and women in the growth-outcome relationship. other moderators examined had varying effects on relationships between ptg and different outcomes; each of which will be discussed in turn. subcategories of positive mental health, and subjective physical health did not significantly moderate their relationship with ptg. however, subcategories of negative mental health did moderate the growth-negative mental health relationship. specifically, in comparison to depression, ptsd symptoms showed a stronger negative relationship with ptg. time since the illness emerged as a significant moderator for positive and negative mental health. in the short term, there was a stronger relationship between ptg and negative mental health, but over time there was an increased relationship between ptg and positive mental health. these results are consistent with the results from a previous meta-analysis looking at ptg following a range of traumas . together these findings suggest that in the short-term ptg is influential in reducing negative symptoms, but in the long-term ptg is more instrumental in enhancing positive well-being. this is consistent with tedeschi and calhoun's ( calhoun's ( , ) functional-descriptive model of ptg, which states that the management of emotional distress is essential in the initial stages post-trauma. on the other hand, ptg reported later might reflect more substantive life changes that have positive consequences for quality of life (tomich & helgeson, ) . time since the health event did not moderate the relationship between ptg and physical health. age appeared to differentially affect the relationship between ptg and adjustment. younger adults demonstrated a stronger positive relationship between ptg and positive mental health. in comparison older adults displayed a stronger negative relationship between ptg and negative mental health. one explanation is that core beliefs of young people may be more affected than those of older people. for example younger people tend to view the world as less just and less benevolent, and the older groups tend to view the world as luckier and more controllable (calhoun, cann, tedeschi, & mcmillan, ) . being diagnosed with cancer or hiv/aids when young might shatter more natural and social rules or beliefs which would generate a greater possibility of reconstructing these core beliefs and therefore promote ptg. another explanation might be that younger people may be more capable and adept at making changes to their lives, which results in enhanced well-being. whereas, older participants may be dealing with other significant life events and be less adaptable compared with younger samples, and therefore ptg may be more useful in reducing and managing distress. age did not act as a significant moderator between ptg and self-reported physical health. ethnicity was a significant moderator of the relationship ptg and all three adjustment measures. specifically, non-white samples displayed a larger effect size for the relationship between ptg and positive mental health and also subjective physical health, compared to samples composed primarily of white participants. in comparison samples composed of predominantly white participants showed a stronger relationship between ptg and negative mental health. this variability may be explained by differences in culture e.g. family, religion, spirituality, which has shown to be important or associated with ptg following stressful life events (milam, a; shaw, joseph, & linley, ; tedeschi & calhoun, ) . because of these differences, growth in ethnic minority samples may reflect more fundamental and existential changes resulting in enhanced wellbeing. in comparison, growth in predominantly white samples may be used more as a strategy to reduce distress. the results of this study should be interpreted with the following limitations in mind. though the present findings indicate that ptg and positive mental health, negative mental health, and subjective physical health are associated (albeit modestly), only cross-sectional data were included in the analysis, which constrains causal inference. for example it is not clear if ptg leads to better psychological and physical health, or if these factors result in an enhanced perception of ptg. furthermore, even though studies were included in the analysis only if they used a clear measure of ptg the final data set consisted of studies that used varying conceptions of ptg, which could be problematic. for example, past research has indicated that benefit finding and ptg are related but distinct constructs, and might therefore have unique predictors and outcomes (sears et al., ) . therefore, future research in the area should ascertain if such constructs are theoretically and empirically interchangeable. the present study did not examine type of illness as a moderator because there were not enough studies of hiv/aids to include cancer vs. hiv/aids as a moderator variable. although research suggests that people with hiv/aids report similar levels and areas of ptg compared to individuals with cancer, there are unique differences between the illnesses, particularly in social responses to individuals with hiv/aids compared to those with cancer (lechner & weaver, ) . for example hiv/aids is an infectious disease and people who are hiv positive may face more stigma because of fear, lack of knowledge concerning transmission, and greater perceived accountability (lechner & weaver, ). this may hinder opportunities for emotional processing and therefore may not facilitate ptg and positive adjustment as readily as cancer and other illnesses. furthermore, meta-analysis, like any other procedure, has its advantages and disadvantages, and this study is no exception. first, where authors of papers reported significant findings but did not include enough statistical information to calculate the effect size, these effect sizes were coded as zero. this is a conservative approach and therefore may have lowered the effect size estimate for each meta-analysis conducted. second, as with many meta-analytic studies, the current findings may over represent those studies that are published and have significant results, preventing the generalization of the current findings to unpublished reports (rosenthal, ) . for the overall effects, our publication bias analysis showed that the population effect size estimates were relatively unaffected when corrected for moderate selection bias. this finding gives us some confidence that the results are not idiosyncratic to our sample of studies. however, when correcting for severe publication bias the effect of growth on positive mental adjustment and physical health became strongly negative (the opposite direction to the population effects). although this is a correction for severe publication bias, the current findings should be viewed within the context of these results. despite these limitations, this study has significant implications for research and practice. a weakness in the literature is the lack of consensus between theorists as to whether ptg is best conceptualized as an adaptive coping strategy that people use following a challenging life event, or as an outcome of the struggle with a traumatic event (affleck & tennen, ; park & helgeson, ; tedeschi & calhoun, . the findings from this study suggest that shortly after the event ptg may be used as a coping strategy to manage and reduce emotional distress associated with the illness threat. however over time ptg grows and is more significant in enhancing positive well-being. this implies that adjustment to serious illness is an ongoing process that occurs over time tedechi & calhoun, ) . as recognized by butler ( ) a challenge of future work is to psychometrically separate these processes so they can be reliably investigated. the results suggest that ptg is associated with a reduction in negative mental health, which was particularly prominent when ptsd symptoms were the outcome. this supports joseph and linley's ( , conceptualization of how ptg and ptsd relate to each other. traumatic events are thought to shatter assumptions about the self and the world and lead to the symptoms of ptsd. these experiences of reexperiencing, avoidance and arousal are viewed as the cognitive emotional processing of the new trauma related information as individuals search for new meaning in life (joseph & linley, ) . as these new meanings are found, and the person's view of themselves and the world is reconstructed, ptg should occur and symptoms of distress should decrease. therefore ptg should be predictive of lower distress, because as people find new meaning they can overcome the cognitive disruption and confusion characterized by ptsd . support for this has been reported by frazier, conlon and glaser ( ) who found that among sexual assault survivors who reported ptg over months were the least distressed. however, joseph and linley ( ) note that this does not mean to imply that the alleviation of distress should automatically lead to the enhancement of growth. according to their organismic valuing theory of growth, ptg should only relate to reduced distress through accommodation (i.e., changing one's global meaning to incorporate the stressor) as opposed to assimilation (i.e., changing one's view of the stressor so that it is consistent with one's global meaning). as such they caution that therapeutic work may impede or disrupt the cognitive processes that are necessary for accommodation and therefore ptg. nonetheless these findings suggest ptg may be a useful target for therapeutic intervention in health care and clinical settings, where the aim is long-term emotional and physical adjustment. psychotherapy for traumatic events such as a serious illness has predominantly focused on the negative effects of trauma, and the goal of therapeutic intervention to promote growth as opposed to alleviate distress will be a major paradigm shift. it is therefore important to raise clinician's awareness of the possibility of positive change. for example, clinicians might recognize the patient's struggle to understand the impact of the illness not only as a posttraumatic response but also as a potential precursor to growth (zoellner & maercker, ) . the empirical study of ways to facilitate ptg is in its infancy and only a few intervention studies have included ptg as an endpoint (antoni et al., penedo et al., ) . nonetheless some interventions, which contain techniques aimed at promoting growth, have shown to successfully improve outcomes. for example antoni et al. ( ) found that a psychosocial intervention that taught participants broad cognitive behavioural stress management techniques, served to increase reports of perceived benefits from having had breast cancer, and simultaneously reduced levels of depression. this study demonstrates that ptg can be altered and can be incorporated easily within cognitive behavioural stress-management interventions. however, the findings from the metaanalysis suggest that clinicians should be sensitive to the timing of ptg discussions. for example the present analysis suggests that ptg might be a useful target in the short-term to reduce distress, but in order to enhance well-being ptg should be targeted later on in the adjustment process. however, in agreement with park and helgeson ( ) it is cautioned that large scale interventions to facilitate ptg in cancer and hiv/aids patients should be avoided until researchers understand more about the origins of ptg, the conditions under which ptg is verdical, the best methods to assess ptg, and its relations to psychological and physical health, are fully understood. care should also be taken to avoid imposing an expectation of ptg in the face of serious illness. patients with cancer or hiv/aids often report feeling burdened with the pressure to stay positive and encouraging the identification of positive changes from their illness may be potentially offensive to patients, serve to minimise their experience and lead them to suppress reports of distress (bellizzi & blank, ; cordova, ) . this meta-analysis of growth in cancer and hiv/aids patients illustrates the promising and exciting nature of this area of research. however, the review also indicates much remains to be learned and highlights areas of research where future work is needed. the present study indicates that in the short term, ptg is associated with a reduction in negative mental health, whereas over longer term, ptg is associated with an enhancement in positive well-being. therefore a clear point of focus is the use of longitudinal studies to further disentangle and clarify the temporal course of this relationship. experimental designs, such as the interventions described earlier, will also help to reveal the causal role of ptg in adjustment and to isolate mechanisms responsible for the effects (algoe & stanton, ). many of the conclusions reached in this paper regarding moderators of the growth-adjustment relationship are based on theoretical considerations rather than on direct empirical evidence and future studies should attempt to validate and test these hypotheses. moreover, to further explicate the growth-adjustment relationship studies should continue to identify additional mediators and moderators. a particularly relevant moderator to medical populations that should be investigated is the perception of the severity of an illness. a previous meta-analysis found that perceptions of the severity of a traumatic event are related to ptg . as such it might be expected that ptg may have a stronger relationship with psychological well-being and physical health for more subjectively severe illnesses and caution must therefore be taken when generalizing the current findings to less threatening illnesses characteristics and indeed wider trauma populations. the majority of the studies included in the present paper measured ptg so that only positive changes were assessed. this could be problematic because participants may develop a 'response bias' which may lead individuals to over-report ptg, and it may also restrict our characterisation of the life changes that health events may precipitate (tomich & helgeson, ) . furthermore, a recent prospective study of severe acute respiratory syndrome (cheng, wong, & tsang, ) found that positive associations between ptg and positive well-being are more likely to be found among individuals who perceive benefits from the event, as well as the costs. therefore, examining positive and negative change simultaneously should be considered as a focus of future research investigating ptg and adjustment in health samples. particularly pertinent for this population is the possibility that ptg can serve to improve physical health. although this paper only looked at subjective measures of physical health there is promising preliminary data which suggests that ptg may be related to better physiological functioning. for example cruess et al. ( ) found that among women with breast cancer, cognitive behavioural stress management reduced levels of cortisol through the enhancement of ptg. yet, no studies have addressed possible mechanisms for the relationship between ptg and physical health. a recent model proposed by bower, low, moskowitz, sepah, and epel ( ) suggests that factors often associated with growth such as coping, positive affect and improved relationships, can lead to a state of enhanced allostasis (maintaining stability, or homeostasis, through change, sterling & eyer, ) , which buffers against future stress responses. this is a promising model, which merits increased attention in future research. furthermore, the relationship between ptg and health behaviours such as exercise, medication adherence, requires a more detailed examination; particularly regarding how these behaviours might moderate the relationship between ptg and physical health. finally, it is acknowledged that the ways in which ptg is manifested might contain elements that are distinctive to specific cultural environments (calhoun & tedeschi, ) . this paper included only three studies conducted in non-western countries and therefore it is clear that there is a need to examine ptg in more diverse ethnic and cultural groups to fully understand the relationship between growth and adjustment. on the basis of this meta-analysis it can be concluded that ptg following cancer or hiv/aids is related to better positive mental health and self-reported physical health, and less negative mental health. this does not preclude that many individuals might experience distress, but rather that ptg is a worthy phenomenon to be studied in clinical and health research. it is hoped that this meta-analysis will encourage further examination of the caveats addressed in this research, so that in the future ptg can perhaps become a viable therapeutic aim in individuals living with a life-threatening illness. construing benefits from adversity: 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surveillance date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: fu blu background: many systems for routine public health surveillance rely on centralized collection of potentially identifiable, individual, identifiable personal health information (phi) records. although individual, identifiable patient records are essential for conditions for which there is mandated reporting, such as tuberculosis or sexually transmitted diseases, they are not routinely required for effective syndromic surveillance. public concern about the routine collection of large quantities of phi to support non-traditional public health functions may make alternative surveillance methods that do not rely on centralized identifiable phi databases increasingly desirable. methods: the national bioterrorism syndromic surveillance demonstration program (ndp) is an example of one alternative model. all phi in this system is initially processed within the secured infrastructure of the health care provider that collects and holds the data, using uniform software distributed and supported by the ndp. only highly aggregated count data is transferred to the datacenter for statistical processing and display. results: detailed, patient level information is readily available to the health care provider to elucidate signals observed in the aggregated data, or for ad hoc queries. we briefly describe the benefits and disadvantages associated with this distributed processing model for routine automated syndromic surveillance. conclusion: for well-defined surveillance requirements, the model can be successfully deployed with very low risk of inadvertent disclosure of phi – a feature that may make participation in surveillance systems more feasible for organizations and more appealing to the individuals whose phi they hold. it is possible to design and implement distributed systems to support non-routine public health needs if required. timely identification and subsequent reaction to a public health emergency requires routine collection of appropriate and accurate data about the occurrence and location of cases of illness. there is substantial interest in using rou-tinely collected electronic health records to support both the detection of unusual clusters of public health events and the response to public health threats detected by other means. such data are also useful to reduce an initial alert level, if it is clear that no unusual illness clusters exist in a community. ideally, such systems operate automatically and include sensitive and specific statistical surveillance software and alerting systems. these are often referred to as syndromic surveillance systems [ , ] , because they typically rely on the non-specific signs and symptoms that may provide the earliest evidence of a serious public health threat, such as anthrax or sars. many syndromic surveillance systems gather potentially identifiable, individual patient-level encounter records. these records are typically collected without name or address, but they do contain enough identifiers to allow re-identification in some circumstances. the potential for re-identification is greatest when records are collected from ambulatory settings or health systems that supply a unique identifier that allows the very useful identification of repeated visits over time. the risk of disclosing sensitive information that can be linked to the individual also increases when the health care facility provides more than occasional care. in the united states, the health insurance portability and accountability act [ ] (hipaa) specifically exempts transfer, use and retention of identifiable electronic personal health information (phi) to support public health activities. this exemption also applies to syndromic surveillance activities, although hipaa was developed before large volumes of such data concerning individuals who are not suspected of having a reportable condition were being used for public health purposes in the absence of any known public health emergency. despite the exemption, data providers may be unwilling to offer identifiable data for surveillance purposes in the face of increasing awareness of the potential costs of inadvertent disclosure or inappropriate use of phi. additionally, their patients may object to their providing it. these concerns are common to many developed countries and under these circumstances, designs that minimise the risk of inadvertent disclosure may be needed in order to gain the cooperation of data custodians, for surveillance systems to be feasible. the focus of this paper is on one such design, in which initial data aggregation is performed to decrease the risk of any phi being inadvertently disclosed, before the aggregate data is centralised for subsequent statistical analysis. although the system we describe is currently operating in the united states and many of the implementation details are specific to that context, some of the conceptual issues we describe and some of the lessons we have learned may be directly relevant to public health practice in other countries. while it is possible to centrally collate and process deidentified records, there is a potential problem with statistical inference if multiple records from the same individual are not distinguished. this problem arises because many statistical analysis techniques applicable to surveillance, such as generalised linear mixed models [ ] (glmm), depend on the assumption that observations are statistically independent. inference based on this assumption using ambulatory care encounter data will likely be biased if the model cannot distinguish observations from multiple encounters during a single course of illness from a single individual patient. although the extent of this bias has not been quantified, the problem is clearly illustrated by real data. in more than half of the individuals with multiple lower respiratory syndrome encounters over a four year period from one large ambulatory care practice, a second encounter with the same syndrome was noted less than days after the first encounter [ ] . our approach to this problem of statistical independence is to aggregate multiple encounters from a single individual into "episodes" of illness, and is described in more detail below. reliably automating this aggregation requires that every patient's records be uniquely identifiable. to support the national demonstration bioterrorism surveillance program (ndp), we developed a system in which no phi leaves the immediate control of the data provider, and only aggregate data is transferred to the datacenter [ , ] . each data provider performs initial aggregation of the phi within their own existing, secured data processing environment, producing data that is aggregated beyond the point where any individual patient is identifiable. since data processing is distributed to the site of data collection rather than being performed at one central location, we describe this as a distributed processing surveillance system. although this particular aspect of our work has briefly been mentioned in previous publications [ , , [ ] [ ] [ ] , we present it in greater detail here, because we believe that it represents a potentially valuable alternative surveillance system design option that deserves more explanation and wider debate than it has received to date. the basic principle of distributed processing is simple. rather than collecting all needed identifiable, individual phi records centrally for statistical processing, all phi is pre-processed remotely, and remains secured, under the direct control of the data provider. only aggregate data are transferred to the central datacenter for additional statistical processing, signal detection, display and distribution. at an appropriate level of aggregation, the risk of inadvertent phi disclosure becomes very small, and may prove acceptable to data custodians and to individual patients. although this risk is never completely absent, it is certainly decreased in aggregate data, making this approach far more acceptable to data providers in our experience, than the more traditional approach of centralized collection of directly identifiable phi. before describing our distributed system, we briefly review the more familiar model of centralized aggregation and processing of phi for surveillance. in the more traditional type of system, individual patient records, often containing potentially identifiable information, such as date of birth and exact or approximate home address, are transferred, usually in electronic form, preferably through some secured method, to a central secured repository, where statistical tools can be used to develop and refine surveillance procedures. one of the main benefits of this data-processing model is that the software and statistical methods can be changed relatively easily to accommodate changes in requirements, because they only need to be changed at the one central location where analysis is taking place. as long as appropriate details have been captured for each individual encounter of interest, the raw data can be re-coded or manipulated in different ways. only one suite of analysis code is needed, and because it is maintained at a single, central location, costs for upgrading and maintenance are small. inadvertent disclosure of phi is always a potential risk with centralized systems. even where minimally identifiable data are stored in each record, the probability of being able to unambiguously identify an individual increases as multiple, potentially linkable records for that individual accrue over time. rather than gathering identifiable phi information into a central repository for analysis, a distributed system moves some of the initial data processing, such as counting aggregated episodes of care (see below), to the site where the data is being collected. this aggregation minimizes the number of individuals who have access to phi and diminishes the risk of inadvertent phi disclosure from the sur-distributed processing model and data flow figure distributed processing model and data flow. veillance system, while still allowing effective use of the information of interest. the focus of this report is on the model used to collect surveillance data while providing maximum protection for phi, so the statistical methods we use in the ndp, which have been described elsewhere [ ] are not discussed further here. data flows for the ndp are illustrated in figure . data pre-processing, detection of repeated visits by the same patient for the same syndrome, and data aggregation is performed using a custom software package, written, maintained, and distributed by the ndp datacenter. data providers maintain complete control of the security of their own phi and also maintain control over the operation of the data processing software, which runs on one of their secured workstations. since the pre-processing takes place within a secured environment under the control of the data provider, there is no need for the individual patient identifiers to be divulged to the datacenter. in the case of the ndp [ ] , the only data that is centrally collated consists of counts of the number of new episodes of specific syndromes over a defined time period (currently set at each hour period ending at midnight), by geographic area (currently, -digit zip code area). more detailed definitions of "syndromes" and "new episodes" are provided below. table illustrates the data transferred from each data provider each day to the datacenter for statistical processing, reporting and alerting. note that the although this data does not contain any obvious identifiers such as date of birth or gender, there is always a risk that a specific individual might be identifiable using additional data, and that this risk is greatest in zip codes with very small populations. all source code required to build the data processing software is provided to the data provider at installation and whenever the software is updated, so that the local information services staff can check that there are no "backdoors" or other ways the distributed software could compromise the security of their systems. all information transferred to the datacenter is stored in text files (in xml format) and can be readily accessed by local staff to ensure that no phi is being transmitted. participating data providers have near real-time icd codes for every encounter, usually assigned by clinicians at the time of the encounter. since much acute infectious disease manifests as broad suites of nonspecific symptoms, we monitor syndromes -respiratory, lower gastro-intestinal (gi), upper gi, neurological, botulism-like, fever, hemorrhagic, skin lesions, lymphatic, rash, shock-death, influenza-like illness and sars-like illness. all syndromes except influenza-like illness and sars-like illness were defined by a working group led by cdc and department of defense [ ] . individual icd codes are used to aggregate encounters into one of these syndromes. the definitions (icd code lists) of of these syndromes are available [ ] . the definitions comprising the other two syndromes were developed in consultation with both cdc and the massachusetts department of public health. our surveillance algorithms [ ] require statistically independent observations and are based on new episodes of syndromes. our goal was to distinguish health care encounters that were related to ongoing care for any given episode of acute illness from the initial encounter that indicated the start of a new episode of a syndrome of interest. the derivation of the specific method for identifying first encounters for an episode of illness has been described in more detail elsewhere [ ] . we define a new episode to begin at the first encounter after at least a day encounter-free interval for that specific patient and that specific syndrome. if there has been any encounter for that specific syndrome for the same individual patient within the previous days, the current encounter is regarded as part of the usual ongoing care for the original encounter that signalled the start of an episode of illness of that syndrome. the start of a new episode for a different syndrome can occur during ongoing encounters for any given specific syndrome -ongoing encounters during an episode are counted as new episodes only if they are outside (i.e. at least days since the last encounter)of an existing episode of the matching syndrome. as will be described later, all ongoing encounters within any syndrome are recorded, and are visible through reports under the control of the data provider, but they do not contribute to the counts that are sent to the datacentre for analysis. all of this processing requires consistent and unique patient identifiers for all encounters. we use the local patient master index record number for this purpose in the software that we provide, but these identifiers are not required once the processing is complete, and they remain under the complete control of the providers. the distributed software requires the data providers to extract information about encounters of interest (daily, in our case) and convert it into the uniform format used by our distributed software. this kind of uniform representation is required for any multi-source surveillance system and is not peculiar to the distributed model we have adopted. in practice, we found that data providers could easily produce text files containing data as comma separated values in the format which we specified, and which the distributed software has been written to process. however, this requires dedicated programming effort that was supported with resources from the ndp grant. our project receives support from the cdc, so we are required to comply with relevant cdc standards. although the data being transferred to the datacenter is arguably not identifiable phi because of the high level of aggregation, we use the public health information network messaging system [ ] (phinms), a freely available, secure, data transfer software suite developed by the cdc, to transfer aggregate data. a phinms server operates at the datacenter and each data provider operates a phinms client, using a security certificate supplied by the datacenter for encryption and authentication. phinms allows fully automated operation at both the datacenter and at each data provider. phinms communicates over an encrypted channel and usually requires no special modification to the data provider firewall, since it is only ever initiated by an outgoing request (the data provider always initiates the transfer of new data) and uses the same firewall port and protocol (ssl on port ) as commercially encrypted services such as internet banking. phinms is reasonably robust to temporary connectivity problems, as it will try to resend all messages in the queue until they are delivered. data transmission is one of the least problematic aspects of maintaining this system. we provide automatic installation software and it runs more or less instantaneously and transparently, without intervention in our experience. no training is needed as the process is fully automated. all data is transferred to the datacenter in the form of extensible markup language (xml) since this is a flexible machine-readable representation and is easy to integrate with phinms. we used the python [ ] language for the development of the distributed software package. this choice was partially motivated by the fact that python is an open-source language and thus freely distributable, partly by our very positive experience with python as a general purpose application development language, and partially because in our experience, python can be installed, and applications reliably run without any change to source code, on all common operating systems (including linux, unix, macintosh and windows), making it easy for the datacenter to provide support for systems other than windows pc's. it is also a language with extensive support for standards such as xml, and securely encrypted internet connections. in addition, our existing web infrastructure has been built with the open-source zope [ ] web application framework, which is written mostly in python. a major design goal for our distributed software was that it should offer potentially useful functions for the data provider. this was motivated by our desire to encourage data providers to look at their own data in different ways that might not only help them manage the data more efficiently, but might also help them to more easily identify errors. in our experience, the task of maintaining a system like the one we have developed is far more attractive and interesting to the staff responsible at each participating institution if they gain some tangible, useful and immediate benefits. in addition, easy access to data flowing through our software is useful for ensuring transparency and to facilitate security auditing by each data provider. the distributed software optionally creates reports that show one line of detailed information about each of the patient encounters that was counted for the aggregate data for each day's processing. these reports are termed "line lists" and were designed to support detailed reporting of encounter level data, so that a data provider can quickly make this information available in response to a public health need. two versions are available, one with and one without the most specific identifying details, such as patient name and address. these standard line lists are used most often to support requests by public health agencies for additional information about the individual cases that contribute to clusters identified in the aggregate data. these lists are never transmitted to the datacenter but may be used to support public health officials investigating a potential event. when unexpectedly high counts of particular syndromes are detected in geographically defined areas, the datacenter automatically generates electronic alerts, which are automatically routed to appropriate public health authorities. for example, in massachusetts, electronic messages are automatically sent to the massachusetts alert network within minutes of detection, where they are automatically and immediately forwarded to the appropriate public health personnel for follow up. available alert delivery methods in the massachusetts system range from email through to an automated telephone text-to-speech delivery system. responders can configure the alert delivery method for each type of alert they have subscribed to. this alerting system is independent of our distributed system, but in practice, the ready availability of reports in electronic format containing both fully and partially identifiable clinical data for all cases comprising any particular period or syndrome makes the task of the clinical responder much simpler whenever a query is received from a public health official. electronic reports, containing clinical information and optionally, full identifiers for all encounters can be generated as required, at the provider's site, from where they can immediately be made available to public health agencies. in the ndp's current operational mode (see figure ), a public health official calls a designated clinical responder to obtain this information. table ). the "narrow" version, which contains fewer identifiers, provides each patient's five-year age group instead of date of birth and does not include the physician id or medical record number (table ) . at the provider's discretion, the clinical responder can provide the "narrow" list corresponding to the cases of interest to the public health department. if on this basis public health officials decide that further investigation is warranted, they can call the clinical provider and request a review of medical records, identifying the cases of interest by date and an index number (unique within date) in the narrow line list. the clinician finds the medical record number by looking up the date and index number in the wide line list and then accesses the record itself through the usual hmo-specific means. resources to support clinical responders were provided through our ndp grant to participating data providers. it would be straightforward to send detailed lists of encounters that are part of clusters directly to the relevant health department whenever the datacenter detects an event and sends an automated alert to a health department. we have not implemented this feature because all the participating health plans prefer to have an on-site clinical responder participate in the initial case evaluation with the public health agency. it would also be simple to allow designated public health personnel to initiate requests for specific line lists, even when no alert has occurred. public health officials may, on occasion, wish to inspect the line lists to search for specific diagnoses that do not occur frequently enough to trigger an alert for their syndrome, but may be meaningful in the context of information that arises from other sources. although not currently implemented in the ndp, it would be feasible to allow a remote user to perform adhoc queries on the encounter data maintained by the health plan. examples of these queries include focused assessment of disease conditions affecting subsets of the population or specific diagnoses. this type of direct query capability is currently used at some of the same participating health plans to support the cdc's vaccine safety datalink project [ ], a surveillance system that supports post-marketing surveillance of vaccine safety [ ] . this distributed data model supports active surveillance and alerting of public health agencies in five states with participating data providers. the system has proven to be workable, and it supports the syndromic surveillance needs of the participating health departments. there are fixed costs such as programming to produce the standard input files, installation and training, associated with adding each new data provider, so we have focussed our efforts on large group practices providing ambulatory care with substantial daily volumes of encounters, completely paperless electronic medical record systems, and substantial technical resources, since these enable us to capture large volumes of transactions with each installation. relatively large numbers of encounters are needed to ensure that estimates from statistical modelling are robust. applying a distributed architecture to surveillance from multiple smaller practices may enable appropriately large numbers of encounters to be gathered, but may prove infeasible because of costs and lack of appropriate internal technical support and because of heterogeneity in the way icd codes are recorded and assigned by each data provider. once the programming for standard input files is completed, installation and training take approximately one day total, usually spread out over the first two weeks. nearly all problems are related to providers getting the standard file format contents exactly right, and to transferring these to the the distributed architecture currently in use by the ndp allows clinical facilities to provide the aggregated information needed to support rapid and efficient syndromic surveillance, while maintaining control over the identifiable phi and clinical data that supports this surveillance. the system provides support for the clinical providers to respond quickly to public health requests for detailed information when this is needed. in our experience, such requests involve only a tiny fraction of the data that would be transferred in a centralized surveillance model, providing adequate support for public health with minimal risk of inadvertent disclosure of identifiable phi. we believe this design, in which patients' clinical data remains with their own provider under most circumstances, while public health needs are still effectively met, conforms to the public's expectations, and so will be easier to justify if these surveillance systems come under public scrutiny. many of the details of our approach are specific to the united states context, but the general principle of using distributed processing to minimise the risk of inadvertent phi disclosure is of potential utility in other developed countries, although the specifics of our implementation may be less useful. the benefit of decreased risk of inadvertent phi disclosure from our approach entails three principal disadvantages compared with routine, centralized collection of identifiable data. first, a clinical responder with access to the locally stored phi data must be available to provide case level information when a cluster is detected. it would be technically straightforward to provide detailed information for relevant cases automatically when signals are detected. we deliberately did not implement this feature in the current system, since the participating health plans expressed a strong preference for direct involvement in this process. the second disadvantage is the need to pre-specify the syndromes, age groups, and other data aggregation parameters in advance, since changing these requires the distribution of a new release of the aggregation software. in practice, we have addressed this by means of configura-distributed software screen, showing results (synthetic data) after daily processing of encounter records figure distributed software screen, showing results (synthetic data) after daily processing of encounter records. tion data for syndrome categories read from a text file as the application loads, so the application code itself does not need alteration. this limitation could be largely overcome by creating a remote query capability to support ad hoc queries on identifiable data that remains in the control of the provider. the third disadvantage is the technical challenge of maintaining distributed software that must reliably process data that the programmers are not permitted to examine. while the software can be exhaustively tested on synthesized data, we have occasionally encountered subtle problems arising from previously unnoticed errors in the input data. our experience suggests that when writing this kind of distributed application, extensive effort must be devoted to detecting and clearly reporting errors in the input data before any processing takes place. an archive of python source code for the distributed software will be made available by the corresponding author upon request. unfortunately no resources are available to provide technical or other support outside the ndp. in summary, we have implemented a near real-time syndromic surveillance system that includes automated detection and reporting to public health agencies of clusters of illness that meet pre-specified criteria for unusualness [ ] . this system uses a distributed architecture that allows the participating health care provider to maintain full control over potentially identifiable phi and health encounter data. the distributed software loads simple text files that can be created from the data stored in virtually any proprietary emr system. it sends summary data suitable for signal detection algorithms via a freely available messaging system, to a datacenter that can manipulate the aggregated information and combine it with data from other providers serving the same geographic region, and which automatically generates and sends alerts when unusual clusters of syndromes are identified. the distributed software also facilitates efficient access to fully identified patient information when needed for following up a potential event. using automated medical records for rapid identification of illness syndromes (syndromic surveillance): the example of lower respiratory infection national bioterrorism syndromic surveillance demonstration program us department of health & human services: health insurance portability and accountability act a generalized linear mixed models approach for detecting incident clusters of disease in small areas, with an application to biological terrorism syndromic surveillance using minimum transfer of identifiable data: the example of the national bioterrorism syndromic surveillance demonstration program use of automated ambulatory-care encounter records for detection of acute illness clusters supported by u /ccu from the centers for disease control and prevention/massachusetts department of public health public cooperative agreement for health preparedness and response for bioterrorism and rfa-cd- - , center of excellence in public health informatics, from the centers for disease control and prevention. figure originally appeared in an article in the mmwr supplement [ ] the author(s) declare that they have no competing interests. rl wrote the first draft of the manuscript after extensive discussions with ky and rp. ky and rp both made substantial intellectual contributions during the evolution of the submitted manuscript. ky prepared figure and all of the tables.publish with bio med central and every scientist can read your work free of charge the pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/ - / / /pre pub key: cord- -m hqxna authors: beck, teresa l.; le, thien-kim; henry-okafor, queen; shah, megha k. title: medical care for undocumented immigrants: national and international issues date: - - journal: physician assist clin doi: . /j.cpha. . . sha: doc_id: cord_uid: m hqxna the number of undocumented immigrants (uis) varies worldwide, and most reside in the united states. with more than million uis in the united states, addressing the health care needs of this population presents unique challenges and opportunities. most uis are uninsured and rely on the safety-net health system for their care. because of young age, this population is often considered to be healthier than the overall us population, but they have specific health conditions and risks. adequate coverage is lacking; however, there are examples of how to better address the health care needs of uis. family foundation, health coverage of immirgants: https://www.kff.org/disparitiespolicy/fact-sheet/health-coverage-of-immigrants/) and % are adults between the ages of and years. more than million people in the united states are the us-born children of uis. about half of uis are of mexican origin; however, these numbers have declined over the last years, from more than million to . million as of . california, texas, and florida have the largest numbers of uis, and nevada has the largest share, making up % of the state's population. [ ] [ ] [ ] [ ] the issue of uis is not unique to the united states. internationally, the united nations population division estimates that there are million to million unauthorized immigrants worldwide, and although most are in the united states, proportionally continental europe has a larger share. although uis have a variety of reasons to migrate, from safety concerns to economic incentives, addressing the health needs of these populations come with unique challenges and solutions. this article provides an overview of challenges in addressing their health needs, existing methods for accessing care, health conditions specific to this population, and potential solutions to consider in both the national and international contexts, specifically in europe. despite the better health status of the younger ui population, this advantage deteriorates over increasing time spent in the united states. various factors from socioeconomic status to fear of deportation affect the ui population's health both domestically and internationally and deter uis from seeking care. the ui population is often of lower socioeconomic status, which adds to the difficulties accessing health care. given that most of the federal insurance plans are unavailable to the ui population, uis are susceptible to higher out-of-pocket costs for care. in addition, because of undocumented status, they may not have sick leave days and may have difficulty negotiating time off from work to seek care. decreased proficiency in the language of the host country and fear of deportation may also present barriers to health care for uis. studies have shown that patients with limited english language proficiency (lep) are at higher risk of poor health and have decreased access to health care. patients who have lep had increased difficulty in understanding their health status as well as accessing preventive services. fear of deportation may lead to the avoidance of seeking care and risk of severe health complications, and this also affects health care for us-born children of uis. in addition, shame and discrimination are common feelings experienced by the ui population and contribute to poor access to health care globally. many of these issues in health care are not unique to the united states. in a study by chauvin and colleagues, % of the ui population in europe had access to health coverage, and, of those, only about % had true access because of barriers such as administrative difficulties, limited language proficiency, and lack of awareness of available services. of the main reasons for lack of access, administrative difficulties in obtaining health care and finances were cited as the most common. france and belgium were found to have the most complicated systems for obtaining health care and, for those who had access, the fear of deportation or imprisonment was prevalent. the patient protection and affordable care act (aca), passed in , required most us citizens and legal residents to have health insurance, and resulted in the expansion of medicaid in states. uis are not eligible for medicaid or state-based exchanges under this law. thus, although the number of overall uninsured in the united states has decreased, it is mostly us citizens and legal residents who have gained access to health insurance. in , congress approved the emergency medical treatment and labor act (emtala), requiring hospitals to provide services for active labor and emergency care regardless of insurance and immigration status. in addition to emtala, there is emergency care under medicaid, which is currently the only federal insurance that is available to uis. emergency medicaid covers patients in active labor and those with acute medical emergencies. it may only be used to stabilize patients and may not cover patients for services after the patient has been stabilized. federal provisions available to uis include prenatal care and care for children funded by maternal and child health block grants and the supplemental food program for women, infants and children. in , the children's health insurance program (chip) was expanded under the chip reauthorization act (chipra). in , federal funding for chip was expanded to states, which included the standard medicaid benefit package such as the early and periodic screening, diagnostic, and treatment services for medically necessary mental health and dental services, vaccinations and prescription drugs, and access to medical specialists and hospital care and services. although these resources are available for a vulnerable subset of uis, there are few resources that exist for sick, nonpregnant adults. federally qualified health centers (fqhcs) are community health centers that receive federal grant funding to support care to the uninsured without regard for immigration status. there are approximately health centers operating around the country, providing primary health care, dental, mental health, and pharmacy services on a sliding-scale basis. in addition, there are many low-cost and free community clinics that rely on private donations and volunteers to provide services to those who cannot afford to pay. europe faces similar challenges regarding access to health care for its ui population. the platform for international cooperation on undocumented migrants (picum) reported that italy and spain provided the widest coverage for ui with universal access to health care. germany, greece, sweden, and switzerland only cover emergency care for uis. table provides an overview of access to care for uis in europe. there is ongoing political debate in the united states regarding health care services for uis. those in opposition maintain that using taxpayer-funded services to support individuals who enter and remain in the united states illegally undermines the legal system. however, some scholars and legislators have argued that it is both unethical and impractical to deny access to health care services for illegal immigrants living in the united states. they view health care as a basic human right and an obligation of a just society to provide health care for everyone. leading medical professional societies such as the american medical association (ama), american college of physicians (acp), the american academy of family physicians (aafp), and the american nurses association (ana) reaffirm the position that all individuals living in the united states, regardless of their immigration status, should have access to quality health care, including the opportunity to purchase insurance. these leaders maintain that providing this population with access to health insurance is an evidence-based way to reduce health care costs. [ ] [ ] [ ] another argument, from a cost perspective, is that many uis will benefit from preventive care and early treatment of chronic diseases before they advance to lifethreatening and costly complications. , proponents of this strategy advocate for improving health literacy and vaccination rates, and offering health screenings to the ui population to try to prevent long-term adverse health outcomes and control cost. moreover, uis may harbor infections such as tuberculosis (tb), which, when undetected, can easily be transmitted to the general public, thus posing a public health risk. in contrast, some have argued that treating uis creates more expenditures for the united states while saving their countries of origin the costs of providing health care. furthermore, they argue that sharing inadequate health care resources with uis will reduce the availability of those scarce resources for us citizens. in the last decades, several states have attempted to advance legislation designed to deny uis access to publicly funded health services. one such initiative was california's proposition . this law, later deemed unconstitutional, required health care professionals to verify immigration status and report uis to authorities. in addition, some believe that continued unabated treatment of uis is an incentive for persistent violation of the immigration laws and threatens national security in the post- / era. proponents of this argument suggest that denying health care to uis will discourage others from attempting to immigrate without proper documentation. there are significant gaps in the literature on the health status of the ui population. immigrants in general, and the undocumented in particular, report lower levels of cancer, heart disease, arthritis, depression, hypertension, and asthma than do the native born. factors thought to contribute to lower rates of reported chronic diseases include the young immigrant population and the process of migration, which, especially in cases of undocumented individuals, positively selects for those healthy enough to make the often arduous journey (ie, the so-called healthy immigrant effect). , in addition, little is known about the long-term health of the children of uis, particularly related to the adverse effects of inadequate prenatal care and the stressors related to undocumented status, which has been shown to negatively affect children regardless of their own legal status. most of the emergency health care services used by uis are for childbirth. a study of emergency medicaid expenditures for undocumented and recent immigrants in north carolina between and found that more than % of health care spending was related to childbirth and complications of pregnancy. of the remaining health care expenditures, one-third was spent on the treatment of acute injuries and poisoning, possibly related to exposure to pesticides or other toxins in the workplace. these uses of health care services reflect not only the young age of most uis but also the type of work that they perform. beyond pregnancy and acute injury, chronic renal failure, cerebrovascular disease, and heart disease were major contributors to emergency medicaid use. various factors associated with undocumented status are thought to erode the health advantage of the undocumented at a faster rate than their documented counterparts. specifically, limited access to quality health care; increased vulnerability caused by low income and occupational status; and the stressors associated with undocumented status, such as fear of deportation, have been implicated. in addition, uis with chronic and infectious medical conditions are negatively affected because of poor access to care. [ ] [ ] [ ] perinatal health of undocumented women and their us-born children is a specific area of concern. consistent with much of the health literature, several studies have found that undocumented women engage in few health risk behaviors while pregnant and seem to have low rates of low-birth-weight or preterm babies. [ ] [ ] [ ] [ ] however, the beneficial effects of better health behaviors during pregnancy are counteracted by the effects of lower rates of prenatal care among uis. poor (and late) prenatal care has been associated with higher risk for adverse perinatal outcomes. , in addition, stressors related to undocumented status, such as fear of deportation or experiences of discrimination and stigma, may adversely affect the physical and emotional health of uis, with potential consequences for their us-born children. , findings from a qualitative study of immigrant families experiencing the arrest of at least parent by immigration authorities, showed an increase in the children's behavioral problems, speech and developmental concerns, and declines in school performance. there is a public health concern over uis bringing infectious diseases into the united states. legal immigrants and refugees are required to have a medical examination for migration to the united states, while they are still overseas. this examination is the responsibility of the centers for disease control and prevention (cdc), which provide instructions to the panel physicians who conduct the medical examinations. the procedure consists of a physical examination, an evaluation (skin test/chest radiograph examination) for tb, and a serologic evaluation for syphilis. requirements for vaccination are based on recommendations from the advisory committee on immunization practices. individuals who fail the examination because of certain health-related conditions are not admitted to the united states. such conditions include drug addiction or communicable diseases of public health significance, such as tb, syphilis, gonorrhea, leprosy, and a changing list of current threats such as polio, cholera, diphtheria, smallpox, or severe acute respiratory syndromes. there is a growing concern that uis crossing into the united states illegally could bring any of these threats. the most prevalent infectious diseases are hepatitis b, latent and active tb, filariasis, intestinal helminth infections, malaria, intestinal protozoa infections, hepatitis c, other nonparasitic infections, sexually transmitted diseases, and human immunodeficiency virus. little is known about the mental health issues of uis. however, the literature suggests that uis have a unique risk profile that may contribute to different mental health outcomes compared with their documented counterparts. themes specific to uis include failure in the country of origin, dangerous border crossings, limited resources, restricted mobility, marginalization/isolation, stigma/blame and guilt/shame, vulnerability/exploitability, fear and fear-based behaviors, and stress and depression. one study compared the diagnoses and mental health care use of undocumented latin american immigrants ( %) with those of documented ( %) and us-born latin americans ( %) treated in this clinical setting. the undocumented latin americans were more likely to have a diagnosis of anxiety, adjustment, and alcohol abuse disorders. the uis also had a significantly greater mean number of concurrent psychosocial stressors compared with documented immigrants and us-born groups, and they were more likely to have psychosocial problems related to occupation, access to health care, and the legal system. other studies have shown increasing rates of substance abuse, binge-eating, and conduct disorders among uis residing longer in the united states. the european immigrant population comes from many different countries, with a heavy concentration from countries in africa, the middle east, and the former soviet union. the most commonly reported health care problems in this undocumented migrant population include mental health, infectious and sexually transmitted diseases, and reproductive health. concerns about human trafficking, particularly of women and children, for commercial sexual exploitation or forced labor or slavery are more prominent in europe. despite the contentious debate over the aca, a consensus has emerged that strengthening primary care will improve health outcomes and restrain the growth of health care spending. supporting evidence comes from studies of primary care as an orientation of health systems and as a set of functions delivered by a usual source of care. although methodological concerns exist, many observational studies in the united states have found that regions with higher primary care physician-to-specialist ratios have better health outcomes, including lower mortality; fewer emergency department visits, hospitalizations, and procedures per capita; and lower costs. international comparisons between industrialized countries also suggest that countries with higher ratings of primary care orientation experience better health care outcomes and incur lower health care costs than countries with lower degrees of primary care orientation. these finding suggest that reducing barriers to primary care for uis may ultimately improve the quality and cost of delivering health care for all countries struggling to manage their growing immigrant populations. several us cities and states with large immigrant populations have attempted to address their health care needs by providing access to primary care. new york city has the nation's largest public health system, composed of the health and hospitals corporation (hhc) and community health care association of new york state, whose members include fqhcs and migrant health programs. these organizations provide much of the health care for uninsured and undocumented patients. both systems rely on medicaid (and, to a lesser extent, medicare) reimbursements. they also depend on federal disproportionate share hospital funding and other sources of state indigent care pool funding. in addition to primary and preventive health care, hhc ambulatory centers offer uninsured patients access to on-site pharmacies and referrals to medical specialists and diagnostic and other services located in hhc medical centers. california offers a medi-cal health insurance plan that provides a full range of lowcost health care options for uninsured californians, with some benefits provided regardless of immigration status. in addition, kaiser permanente offers a child health program for uninsured california children younger than years who do not have access to medi-cal or other coverage, regardless of immigration status. my health la (mhla) is a no-cost health care program that offers comprehensive health care for low-income, uninsured los angeles county residents, regardless of immigration status or medical condition. it offers care through community clinic medical home sites, where patients receive primary and preventive health care services and some diagnostic services. los angeles county department of health services facilities also provide county clinic medical home sites, plus emergency, diagnostic, specialty, inpatient services, and pharmacy services. healthy san francisco (hsf) is a low-income program for san francisco county residents regardless of employment status, immigration status, or medical condition. unlike mhla, hsf charges a participation fee and point-of-service fee to all patients except for those at less than % of the federal poverty level and those who are homeless. the harris county health system, which includes the city of houston, texas, offers access care, a financial assistance program open to uninsured and undocumented harris county residents, and provides access to discounted health care at more than community clinics, a dental clinic, and surgical and other subspecialty clinics. the harris health system has a dialysis clinic as well as a long-term care facility. in massachusetts, all immigrants are eligible for some form of health coverage. there is application for all available programs, including the insurance marketplace. mass health limited is the state version of emergency medicaid. it is available to uis and some immigrants who are prucol (permanent residence under color of law), defined as aliens who are living in the united states with the knowledge and permission of the federal government, and whose departure the agency does not contemplate enforcing. in nevada, the nonprofit access to healthcare network (ahn) offers medical discount programs, specialty care coordination, a health insurance program, nonemergency medical transportation services, a pediatric hematology/oncology practice, and a toll-free statewide call center. ahn has , members, more than half of whom are presumed to be undocumented. a study by hacker and colleagues identified areas to address barriers to care for uis: advocacy for policy, insurance options, expansion of the safety net, training of providers, and education of uis on navigating the system ( table ) . nearly all industrialized countries provide some form of government-supported health care to all of its residents, including those who are undocumented (see table ). although countries in the european union have significantly fewer uis, their models may offer insights on the options and challenges of addressing this health care dilemma facing the united states. medical care for uis is a complex area involving challenges for accessing care, barriers in financing care, and unique medical conditions. fear, stigma, cost, and cultural barriers often prevent uis from seeking medical care. uis make up a small but substantial portion of the population in the united states and internationally, and there is an emerging interest in finding solutions to address their health care needs. in the united states, cities with large numbers of immigrants have models that provide health care to their uninsured regardless of immigration status, and could potentially be expanded to other areas of the country experiencing increasing growth of their immigrant populations. international approaches may also inform on policies to address the health care needs of uis. 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utilization of mental health services among undocumented immigrant latinos primary care: a critical review of the evidence on quality and costs of health care undocumented immigrants and access to health care in new york city: identifying fair, effective, and sustainable local policy solutions: report and recommendations to the office of the mayor of key: cord- - hxrpi authors: nuzzo, jennifer b.; meyer, diane; snyder, michael; ravi, sanjana j.; lapascu, ana; souleles, jon; andrada, carolina i.; bishai, david title: what makes health systems resilient against infectious disease outbreaks and natural hazards? results from a scoping review date: - - journal: bmc public health doi: . /s - - -z sha: doc_id: cord_uid: hxrpi background: the – ebola outbreak was a wake-up call regarding the critical importance of resilient health systems. fragile health systems can become overwhelmed during public health crises, further exacerbating the human, economic, and political toll. important work has been done to describe the general attributes of a health system resilient to these crises, and the next step will be to identify the specific capacities that health systems need to develop and maintain to achieve resiliency. methods: we conducted a scoping review of the literature to identify recurring themes and capacities needed for health system resiliency to infectious disease outbreaks and natural hazards and any existing implementation frameworks that highlight these capacities. we also sought to identify the overlap of the identified themes and capacities with those highlighted in the world health organization’s joint external evaluation. sources of evidence included pubmed, web of science, oaister, and the websites of relevant major public health organizations. results: we identified themes of health system resilience, including: the need to develop plans for altered standards of care during emergencies, the need to develop plans for post-event recovery, and a commitment to quality improvement. most of the literature described the general attributes of a resilient health system; no implementation frameworks were identified that could translate these elements into specific capacities that health system actors can employ to improve resilience to outbreaks and natural hazards in a variety of settings. conclusions: an implementation-oriented health system resilience framework could help translate the important components of a health system identified in this review into specific capacities that actors in the health system could work to develop to improve resilience to public health crises. however, there remains a need to further refine the concept of resilience so that health systems can simultaneously achieve sustainable transformations in healthcare practice and health service delivery as well as improve their preparedness for emergencies. health system resilience has been previously defined as "the capacity of health actors, institutions, and populations to prepare for and effectively respond to crises; maintain core functions when a crisis hits; and, informed by lessons learnt during the crisis, reorganize if conditions require it" [ , ] . for many countries, the - ebola outbreak in west africa was a wake-up call regarding the critical importance of having resilient health systems. in each of the three countries most affected by ebola, a fragile health system was quickly overwhelmed by the complexity of tracking cases, the need to create and disseminate communication strategies, and the challenges of safely caring for a surge of critically ill patients. health workers were - times more likely to have been infected with the virus than members of the general public [ ] . sickened health workers could no longer care for ebola patients, and poor infection control in healthcare facilities contributed to nosocomial ebola transmission. in turn, heightened risks of nosocomial ebola infection increased public fear around hospitalization [ ] . rather than helping to contain ebola, health systems became an amplifier of disease, exacerbating the human, economic, and political toll of the outbreak. similarly, unprepared health systems across the world inadvertently contributed to disease transmission during recent epidemics of severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers) [ ] . health systems that were unprepared for disasters were also unable to provide essential services, even in highly developed countries (e.g., canada during sars [ ] , korea with mers [ ] , and the us following hurricane sandy [ ] ). many countries have committed resources and efforts toward health system strengthening based on these recent disasters, but actionable plans and approaches to build resilient health systems have not yet achieved consensus. independent reviews of the global response to the - ebola outbreak have stressed the importance of establishing metrics to assess and monitor progress towards improving countries' capacity to respond to public health emergencies [ ] [ ] [ ] . in , the world health organization (who) created the international health regulations (ihr) joint external evaluation (jee) tool-a framework and process designed to measure countries' capacities to implement the requirements of the ihr, which include the ability to prevent, detect, and respond to public health emergencies of international concern [ ] . since its introduction, the jee has become an important tool used by countries to assess their capacities for infectious disease outbreaks and other public health emergencies. to-date, more than countries have conducted jee assessments [ ] . some countries that have undergone jee assessments have also begun to develop action plans to address gaps found in their jees. despite this progress, health facilities continue to be vulnerable to public health emergencies [ ] . important work has been done to describe the general attributes of a resilient health system [ , , [ ] [ ] [ ] . for example, kruk et al. describe a resilient health system as one that is "integrated with existing efforts to strengthen health systems," able to "detect and interpret local warning signs and quickly call for support," able to provide care for a diverse population, able to "isolate threats and maintain core functions," and is able to "adapt to health shocks" [ ] . however, as highlighted by turenne et al., there continues to be a lack of clarity around the conceptualization of health systems resilience [ ] . the aim of this scoping review was to draw from existing literature to characterize specific capacities required to build resilient health systems in the face of infectious disease emergencies and natural hazards, with an emphasis on highlighting potential efforts that health system actors (e.g. health facilities and health service delivery organizations that are not always well-integrated in government-led preparedness initiatives) could pursue to achieve desired health outcomes during health crises. we also sought to examine the extent to which capacities that are associated with resilient health systems are addressed by existing frameworks for measuring and motivating countries' health security, such as the jee. we searched the scholarly and grey-literature databases to identify which capacities should be included in a framework for assessing and improving health system resilience to infectious disease outbreaks and natural hazards. we also sought to determine whether there were existing frameworks that highlighted these capacities that could be used in low-, middle-, and high-income settings. for the purposes of our research, we used the who definition of health systems, defined as "all the activities whose primary purpose is to promote, restore, or maintain health" [ ] . specifically, we integrated literature in the following three areas: health security, health systems strengthening, and quality improvement. the aims of this research were to characterize the impacts that infectious disease outbreaks and natural hazards have on health systems; to identify challenges in maintaining health service delivery during outbreaks and natural hazards; and to identify strategies for effecting sustainable change in health systems-strengthening efforts. literature databases included pubmed, web of science, and oaister. key search terms were informed by, but not inclusive of, kruk et al.'s definition of a resilient health system, and included "health system," "health system strengthening," "resilience," "recover," "quality improvement," "infectious disease," "outbreak," "natural disaster," "global health security," "pandemic," "outbreak response," and "essential functions," as well as a variety of different pathogens responsible for recent infectious disease outbreaks (e.g., sars, ebola) and natural hazard types (e.g., cyclone, earthquake). see additional file : table s for the full electronic search strategy. additionally, we examined the websites of major relevant public health organizations (who, the rockefeller foundation, cdc stacks) to identify articles and frameworks not indexed in the aforementioned databases. all but one of the search results were filtered to include only those articles published during or after , to capture literature emanating in the wake of the sars epidemic, up until february , the end of the study period. however, one search term did included articles published during or after , to capture more broadly those resources that focused on essential health functions. only english-language articles were considered. we included documents if they described health system capacities that could potentially strengthen health system resilience to either infectious disease threats or natural hazards. documents were excluded if they described health capacities that were outside the aims of this research, as defined previously (i.e. articles that were purely about public health capacities that did not mention the relationship of these capacities to the healthcare system). for example, articles that described the importance of a trained epidemiologic workforce (a public health capacity) in outbreak identification and mitigation would be excluded. articles about the importance of engagement between ministries of health and the public would be excluded; however, articles about the importance of engagement between healthcare facilities and ministries of health would be included. documents were also excluded if the article described resilience in contexts outside of natural hazards and infectious disease outbreaks (i.e. armed conflict situations). each of the research team members ( in total) was assigned a set of articles to review. each article title was reviewed by the assigned researcher for relevancy using the previously mentioned inclusion and exclusion criteria, followed by a review of the abstract for those titles deemed relevant. all articles deemed relevant after title and abstract review were then read in their entirety by the assigned researcher, providing a final set of articles for analysis. article references were also reviewed to identify important literature not located in the primary search. articles were then thematically coded by the assigned researcher using qrs international's nvivo coding software [ ] and a qualitative coding instrument developed from a priori themes previously identified in other resilience checklists [ , , , ] . additional topics of interest that did not fit into the previously identified thematic rubric were coded as "other" for further review during data analysis. after completion of coding, through a process of inductive and deductive reasoning, the researchers identified a final list of themes and associated key literature that described the critical capacities necessary for health system resilience to infectious disease outbreaks and natural hazards. we then sought to identify areas of overlap between the health system resilience themes and capacities identified in our literature search, and the specific health security capacities that are the focus of the jee. the search yielded a total of articles after the removal of duplicates (additional file : figure s ). one hundred and fifty-eight articles were read in their entirety, of which were deemed to be relevant and underwent thematic coding. after the completion of coding, we identified key documents that described high-level themes of health system resilience, which are summarized in additional file : table s (see additional file : appendix a and appendix b for a comprehensive breakdown of sources organized by theme and author). thirty-nine papers focused primarily on infectious diseases, while another addressed natural hazards. the remaining papers were not threat-specific, but rather articulated general principles for strengthening health systems and described baseline capacities required for health system functioning. while the themes found in our search were consistent with the five elements of a resilient health system previously outlined by kruk et al. [ , ] , we also identified three additional themes not included in previous reviews, including the need to: develop policies for determining what level of care will be delivered when the level of demand exceeds existing resources; plan for post-event recovery; and commitment to quality improvement that ensures integration of lessons learned. for example, mehta et al. described the need to develop "altered standards of care" for responses to mass casualty events, which might include shifting resources to save as many lives as possible (i.e., triaging patients differently during emergencies as compared to normal operating conditions) and allowing for group isolation of patients that would normally be boarded in single rooms [ ] . the literature identified a number of issues that must be addressed during the recovery phase of a public health emergency, including the need for grief and psychological counseling [ ] , after-action assessment and revision of emergency response plans [ ] , and rebuilding of social cohesion and trust [ ] . a commitment to continuous quality improvement was also identified as an important component of resilient health systems, including making hospital performance ratings mandatory and publicly available to encourage peer competition with the primary goal being the overall improvement of hospital performance [ ] . in integrating literature across subject areas, we were able to identify multiple references to the capacities necessary to achieve the health system resilience attributes identified in our scoping review, which are summarized below (also see additional file : table s ). core health service capabilities: a resilient health system sustains baseline levels of routine healthcare delivery during a public health emergency [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . barriers to healthcare access: a resilient health system dismantles barriers to healthcare access so that the public accesses care during emergencies [ , ] . maintaining critical infrastructure and transportation: a resilient health system develops plans to weather interruptions in critical infrastructure and transportation [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . timely and flexible access to emergency/crisis financing: a resilient health system has timely, flexible access to financing so that it can better prepare for and respond to public health emergencies [ , , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . leadership and command structure: a resilient health system has a clear and flexible command structure that has been established prior to an event and is exercised frequently [ , , , [ ] [ ] [ ] [ ] [ ] [ ] . collaboration, coordination, and partnerships: a resilient health system collaborates and coordinates with partners within and outside of the health system [ , , , , , , ] . communication: a resilient health system has clear channels of communication between health system actors and other sectors, risk communication protocols, and robust engagement with patient populations [ , ] . flexible plans and management structures: a resilient health system has flexible plans and management structures to cope with rapidly evolving circumstances [ , [ ] [ ] [ ] . legal preparations: a resilient health system has made legal preparations to address challenges that may emerge during a crisis [ , , , , , , ] . surge capacity: a resilient health system is able to call on human and capital resources to "surge" the level of care during public health emergencies [ , ] . altered standards of care: a resilient health system has adaptable response plans to guide them in allocating scarce resources and healthcare services [ , ] . health workforce: a resilient health system has an adequate, trained, and willing work force [ , , , , , , , , ] . medical supplies and equipment: a resilient health system has access to medical supplies and equipment, including personal protective equipment, antivirals, and ventilators, during a crisis [ , , [ ] [ ] [ ] . infection prevention and control (ipc): a resilient health system has implemented strong ipc measures, including staff training, standardized protocols, a dedicated ipc focal point, and dedicated treatment units [ , , , , , , [ ] [ ] [ ] [ ] [ ] [ ] . commitment to quality improvement: a resilient health system requires a commitment to continuous quality improvement that promotes excellence and garners the trust of the community [ , , , , , , ] . plans for post-event recovery: resilient health systems have plans for post-event recovery that address a broad range of issues [ - , , , , , - ] . the capacities that we identified are associated with different actors in health systems. some of the capacities identified in our review could potentially be developed by individual health facilities. for example, kim et al. discussed one health system's plan to develop alternate care centers that could be deployed during an influenza pandemic, including the infrastructure that needs to be in place to ensure adequate functioning, such as transport of patients to the center [ ] . other capacities identified in the scoping review concerned the health system more broadly and would likely be addressed by national governmental authorities. for example, hanefeld et al. noted "the nature of the funding and financing mechanism as a core aspect enabling or hindering health systems' ability to respond to a shock" [ ] . no frameworks were identified in the search that translated these high-level themes into specific and actionable steps that health system actors can employ to improve and support health system resilience to both infectious diseases and natural hazards, and that can be undertaken in low-, middle-, and high-income settings alike. frameworks that did articulate specific capacities were either ) only applicable in the us context [ ] or ) did not cohesively address both infectious diseases and natural disasters [ ] . for example, meyer et al. created a checklist for health sector resilience to highconsequence infectious diseases [ ] , but the data for this checklist was informed by the us domestic response to the - west africa ebola outbreak. while some of the identified capacities may be generalizable to other countries, some are only pertinent in the us context. similarly, the hospital safety index, a tool developed by who, does identify capacities that are relevant to some health facilities, but the tool is largely aimed at evaluating the vulnerability of hospital infrastructure to natural hazards (an updated version includes limited consideration of the potential impact of infectious disease threats to hospitals) [ ] . only two of the health system resilience themes and capacities identified in our literature search directly overlapped with the specific health security capacities that are the focus of the jee-namely ipc and communication (see additional file : table s ). specifically, the jee indicator on antimicrobial resistance does address ipc, but only within the context of healthcareassociated infections and associated ipc programs [ ] . additionally, the literature we collected emphasized the importance of communication between health system actors, other sectors, and the community during outbreaks [ , ] . the jee contains a very detailed section on communication that specifically calls out for the need for communication and coordination between stakeholders, including healthcare workers; for systems for rumor management through healthcare workers; and for formal communication mechanisms with the hospital and healthcare sector [ ] . otherwise, health facilities are not directly addressed in the jee framework. there are some indicators in the jee that do address the themes identified in the literature review, but only within the context of public health. for example, the literature suggests that health facilities need access to financing during emergencies to cover the added costs of preparing for and responding to emergencies [ , , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the jee indicator on national, legislation, policy and financing does address whether countries have the financing to fulfill their obligations under the ihr, which includes "regulations or administrative requirements, or other governmental instruments governing public health surveillance and response" [ ] . however, it does not specifically address financing within the context of health facilities, although countries could choose to include them in efforts to develop capacities in those areas. finally, some of the themes identified in our review could be leveraged through the development of other capacities that are the focus of the jee. for example, the jee does not explicitly assess how healthcare facilities should address barriers to healthcare access, such as long travel distances, the high cost of medical care, and public distrust. however, it does address the importance of risk communication and community engagement during an emergency. these relationships could potentially be leveraged by the healthcare system during an emergency to improve the public's trust in and subsequent use of the healthcare system. to date, much of the literature that specifically references health system resilience has focused on high-level attributes, rather than identifying specific capacities that health systems need to be resilient to infectious disease outbreaks and natural hazards. for example, kruk et al.'s five attributes of a resilient health system include a system that is "self-regulating," with the ability to "quickly identify and isolate a threat and target resources to it" [ ] . by integrating literature from across different disciplines, we were able translate these high-level themes into actionable corresponding capacities that health systems need to respond to infectious disease outbreaks and natural hazards. for example, the literature highlighted numerous ipc protocols and practices that are important for the control of infectious disease threats, including the need for front-line healthcare workers to conduct travel histories [ ] and the need to establish dedicated and multidisciplinary ipc committees to coordinate and guide healthcare staff on how to safely manage patients with infectious diseases [ , ] . an article by palagyi et al., published after this review was conducted, also highlights the importance of these capacities that we identified [ ] . additionally, the literature highlighted three themes not previously identified as attributes of a resilient health system, which warrant consideration in future efforts to define health system resilience. we present the capacities that we identified across the literature as merely the beginning of an effort to define capacities that health system actors need to be prepared for infectious disease outbreaks and natural hazards. further scholarship in these areas could support efforts to translate research findings into best practices in public health and healthcare practice and improve health outcomes following public health emergencies of all kinds. notably, the jee does identify the capacities necessary to implement the ihrs to protect against public health emergencies of international concern, but lacks guidance for health facilities at the patient-provider interface [ ] . moreover, many of the capacities assessed in the jee presume the existence and functioning of core health system capacities, yet these capacities themselves are not explicitly addressed in jee assessments. for example, while the presence of a national laboratory system-a jee indicator-is a critical capacity to have during an outbreak, it requires that healthcare providers and the proper supplies be available to collect patient samples (e.g., blood, sputum, etc.). ideally, efforts to improve health system resilience would complement and build upon those foundational capacities presumed by the jee process. the results of this literature review point to a need for increased integration of efforts to advance health security and health systems strengthening across the globe. several high-priority elements for health systems resilience likely exist at the nexus of health systems strengthening, health system resilience, and health security; further work is needed to determine the most effective co-investments in global health security and health system strengthening that enable more robust health system responses at the local, national, regional, and global levels during emergent crises [ ] . identifying those areas of overlap can help to actualize the jee's priority areas in health security, and also strengthen key components of national health systems such that their overall resilience is enhanced. while we strived to capture all relevant health systems literature, a potential limitation to our review is the lack of consistency and definitional clarity with which terms like "health system" and "resilience" are used throughout the medical and public health literature. it is possible that we may have missed relevant articles that describe these concepts using different terms. we also found in the literature an overrepresentation of papers detailing health system impacts of certain events and, thus, our findings may not include considerations from other events not represented in the literature. despite these limitations, we think our review serves to deepen the understanding of the specific capacities that health systems need to prepare for infectious diseases and natural hazards. the themes and capacities identified in our literature review provide an initial step in refining the concept of health system resilience to enable actors across the various sectors of the health system to take action to be able to respond and recover from infectious disease outbreaks and natural hazards. there remains a need to further define the concept of resilience so that health systems can simultaneously achieve sustainable transformations in public health practice and health service delivery as well as improve their preparedness for emergencies. in the same way that the jee tool has helped motivate countries to assess and improve their core public health capacities, an implementationoriented health system resilience framework could help translate the important components of a health system identified in this review into specific capacities that actors in the health system could work to develop to improve resilience to public health crises. moreover, such an effort may help to integrate foundational health system capacities into national efforts to improve core public health capacities. supplementary information accompanies this paper at https://doi.org/ . /s - - -z. additional file : table s . electronic search strategy. table s . summary of key themes and associated key evidence. table s . overlap of scoping review themes with joint external evaluation 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case studies of northern uganda and sierra leone vertical interventions and system effects; have we learned anything from past experiences? rebuilding transformation strategies in post-ebola epidemics in africa health system preparedness for emerging infectious diseases: a synthesis of the literature who | health security and health systems strengthening -an integrated approach publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations not applicable. this research was supported by the rockefeller foundation. the rockefeller foundation had no role in the study design, data collection, data analysis and interpretation, in the writing of the report, or the decision to submit it for publication. key: cord- - a n dc authors: charitos, ioannis a; ballini, andrea; bottalico, lucrezia; cantore, stefania; passarelli, pier carmine; inchingolo, francesco; d'addona, antonio; santacroce, luigi title: special features of sars-cov- in daily practice date: - - journal: world j clin cases doi: . /wjcc.v .i . sha: doc_id: cord_uid: a n dc the severe acute respiratory syndrome-coronavirus- (commonly known as sars-cov- ) is a novel coronavirus (designated as -ncov), which was isolated for the first time after the chinese health authorities reported a cluster of pneumonia cases in wuhan, china in december . optimal management of the coronavirus disease- disease is evolving quickly and treatment guidelines, based on scientific evidence and experts’ opinions with clinical experience, are constantly being updated. on january , , the world health organization declared the sars-cov- outbreak as a "public health emergency of international concern". the total lack of immune protection brought about a severe spread of the contagion all over the world. for this reason, diagnostic tools, patient management and therapeutic approaches have been tested along the way, in the desperate race to break free from the widespread infection and its fatal respiratory complications. current medical knowledge and research on severe and critical patients’ management and experimental treatments are still evolving, but several protocols on minimizing risk of infection among the general population, patients and healthcare workers have been approved and diffused by international health authorities. the severe acute respiratory syndrome-(sars-) coronavirus (cov- ), officially named as "coronavirus disease- (covid- )" by the world health organization (who) on february , , is actually the novel coronavirus responsible for one of the most severe worldwide pandemics in recent history [ ] . on january , , the chinese center for disease control and prevention (cdc) reported and confirmed that a cluster of cases of acute pneumonia in people associated with the huanan seafood wholesale market in wuhan, a city in the hubei province of china, were caused by a novel coronavirus, -ncov [ ] [ ] [ ] . from that day, the epidemic spread throughout china, being followed by a rapidly increasing number of cases in other countries throughout the world, with a high morbidity and mortality ratio [ , ] . on march, , the director-general of the who declared covid- a global pandemic [ ] . the coronavirus subfamily, nidovirales order, includes four genera: alpha, beta, gamma, and delta coronaviruses. they are medium-sized, enveloped, positivestranded rna viruses which replicate using a nested set of mrnas [ , ] . their genetic material represents the largest known viral rna genomes (between - kb). the host-derived membrane surrounds the genome, encased in a nucleocapsid, and contains glycoprotein spikes. viral rna replication by rna polymerase occurs in the host cytoplasm. the coronaviruses genome encodes four or five structural proteins [ ] . coronaviruses are very common among birds and mammals, especially in bats, pigs and feline, which represent the major hosts [ , ] . the human coronaviruses (hcovs) number seven. there are five non-sars september , volume issue coronavirus serotypes (two beta coronaviruses -hcov-oc and hcov-hku and two alpha coronaviruses -hcov- e and hcov-nl ) [ ] and a novel coronavirus, the middle east respiratory syndrome coronavirus (mers-cov), that emerged in [ ] . they are community-acquired viruses that continually circulate through the human population, causing asymptomatic infections, accounting for % to % of overall colds and upper respiratory tract infections during winter in adults and some proportion of lower respiratory illness in children [ , ] . in contrast, the last two beta coronaviruses -sars-cov and sars-cov- -jumped to the human population in and respectively, causing acute pneumonia, with a higher mortality rate. respiratory coronaviruses probably spread in a fashion similar to that of the rhinoviruses, via direct contact with infected secretions or large aerosol droplets [ ] [ ] [ ] [ ] . protein-protein binding assays have confirmed that angiotensin-converting enzyme (ace ) is most likely to be the cell receptor through which the virus invades the host cell [ , ] . the scientific community is currently trying to identify the source of the infection, which is still uncertain. according to recent lines of evidence, in late , someone at the huanan seafood market in wuhan was infected with sars-cov- , but specific animal associations have not been confirmed. the viral infectious disease then spread from that first cluster in the capital of china's hubei province to a pandemic. some argue that the involved animals would be bats and pangolins [ ] . the spread of covid- caused by the sars-cov- outbreak has been growing since its first identification in december . on may , , the who's coronavirus disease situation report counted confirmed cases globally since the beginning of the global pandemic and a total of deaths all over the world [ ] . actually, the case fatality rate of the ongoing covid pandemic (the ratio between confirmed deaths and confirmed cases) is . % for the world and . % for italy [ , ] . as a comparison for this global value with the case fatality rate of other coronavirus outbreaks, it was % for sars-cov and % for mers-cov [ ] , instead and approximately between . %- . % for the seasonal flu [ ] [ ] [ ] [ ] . covid- is a new disease and there is limited information regarding risk factors for developing a severe case. what we know is that the covid- pandemic has shown an opposite behaviour than that of other global infectious diseases. indeed, for many other viral and bacterial diseases, such as the previous 'spanish flu' pandemic in and malaria (which is still endemic in many areas of the world), the majority of deaths were young and children; for covid- cases, the elderly are at the greatest risk of dying if infected with the virus. yet, old age is not an isolated risk factor for developing a severe acute viral pneumonia by covid- . based on currently available information, older adults, but also people of any age, who have serious underlying medical conditions might be at higher risk for severe illness. in fact, analysing the case fatality rate of each condition shows that those with an underlying health condition have a higher percentage than those without. more than % of people with a cardiovascular disease, more than % of people with diabetes, % with chronic respiratory disease or moderate to severe asthma, % with hypertension, and more than % with cancer who were diagnosed with covid- have died [ ] . other important risk factors for developing severe complications of covid- disease are related to immunocompromised status due to congenital and acquired immune-deficiencies (i.e., cancer treatment, bone marrow or organ transplantation, autoimmune deficiency syndrome, prolonged use of corticosteroids and immunosuppressive drugs), severe obesity (body mass index of or higher), hypertension, liver disease, chronic kidney disease undergoing dialysis, and cerebrovascular diseases [ , [ ] [ ] [ ] . a possible reason why the elderly are most at risk of dying from covid- might be the fact that they are also most likely to have underlying health conditions. italy and other european countries emerged early on as the countries with the largest outbreaks of the novel sars-cov- outside asia. several prevention and containment measures have been applied worldwide to contain the covid- disease. in italy, the particular seriousness of covid- disease regarding morbidity and mortality and the enormous overload of intensive care units (icus) brought about the italian government's establishment of a series of decree laws [ ] , from february to may , to apply strict and extensive containment measures in all of the italian territory. most non-essential commercial activities were temporarily stopped. the decrees also restricted movements within the regional territory and beyond it, except for proven work reasons, absolute urgency, or for health reasons. but, first of all, to limit the spread of the contagion, careful personal hygiene measures were highly recommended, such as frequent hand-washing, interpersonal safety distancing of at least m to avoid close contacts with potentially infected people, the mandatory use of masks in public closed spaces, and the constant sanitization of public spaces. thanks to all these measures and practices, on may , , the italian government declared initiation of the so-called "phase two" [ ] [ ] [ ] , a period of greater freedom but always with strong recommendations of respecting constant hygiene measures and being on alert for eventual rise in new cases. social distancing is fundamental to prevent the inter-human spread of covid- though flügge's drops, produced as a result breathing, talking, sneezing, or coughing and able to contaminate surfaces. according to the latest release from the national health commission, known as the prc, sars-cov- is believed to be transmitted mostly through respiratory droplets and close contacts. prolonged exposure to high concentrations of aerosols may facilitate transmission. spread is also possible through the conjunctiva. it will be very important during the summer of to better investigate the possible role of air conditioning systems in increasing the virus circulation. finally, an observational study found that sars-cov- does not seem to be present in breast milk and its transmission may take place through respiratory droplets rather than the milk; for this reason, it is not recommended to interrupt breastfeeding [ , ] . sars-cov- persistence (and infectivity) on different surfaces (liquid, solid, or gaseous) is still debated. the % tissue culture infective dose (tcid ) is the measure of infectious virus titre. this endpoint dilution assay quantifies the amount of virus required to kill % of infected hosts or to produce a cytopathic effect in % of inoculated tissue culture cells. a recent experiment performed using aerosols (< µm) containing sars-cov- ( . tcid per ml) showed a reduction from . to . tcid per l of air after h, a reduction from . to . tcid per ml on plastic after h, and the same reduction after h on stainless steel [ ] . these results show a persistence of sars-cov- for many hours on surfaces in experimental conditions, but further peer-reviewed investigation on this topic is needed because it represents an environmental and public health problem concerning hospitals (especially in covid departments), schools, offices, and every day public places. furthermore, previous studies have found that air pollution is a risk factor for respiratory infection, by carrying microorganisms, but it also causes oxidative, proinflammatory and immunological damage to the lungs. various recent studies have explored the relationship between ambient air pollutants and covid- infection. most of these have shown a relationship between long-term exposure to air pollution in cities and risk of infection [ ] [ ] [ ] [ ] . another study investigated in the united states whether long-term average exposure to fine particulate matter (pm . ) is associated with an increased risk of covid- death. it was found that an increase of only μg/m in pm . increases vulnerability to experiencing the most severe covid- outcomes, with statistically significant evidence that this exposure is associated with a % increase in the covid- mortality rate [ ] . however, caution should be used in translating high values of conventional aerosol metrics, such as pm . and pm concentrations, in a mortality predictive factor, because many biases may interfere in a real-life situation, relating to different temperature, humidity, and ultraviolet radiation. we can interpret these data considering air pollution as an additional risk factor for covid- disease, which might contribute to increasing the vulnerability and the clinical outcome, probably also through a previous increase in heart diseases, lung problems and cancer. this could also partially explain the prevalence of the infection in the most industrialized cities of the world, northern italy included, and the effect of national lockdown. finally, it could provide implications for the control and prevention of this novel disease and underscores the importance of continuing to enforce existing air pollution regulations to protect human health both during and after the covid- crisis. as the clinical spectrum of covid- ranges widely from asymptomatic cases to severe pneumonia with a high risk of mortality, there is a need for more research to identify the earliest markers of disease severity. the incubation period for covid- is currently estimated to be between d and d. most infected people develop mild to moderate illness and recover without hospitalization. in the early phases of the disease, clinical manifestations are very unspecific, so differential diagnosis should include other infectious viral diseases that appear with the same symptoms, such as influenza and parainfluenza, the common cold caused by rhinovirus, and those caused by human metapneumovirus, human respiratory syncytial virus and adenoviruses, but also with non-infectious (e.g., vasculitis, dermatomyositis) common respiratory disorders. the most common symptoms of covid- infection are fever (not very responsive to antipyretics), dry cough, dyspnoea and increased respiratory rate (in more fragile patients, the dyspnoea may appear at the onset of symptoms, while in younger subjects without other comorbidities it may appear later), myalgia, and intense fatigue [ ] [ ] [ ] [ ] . clinical studies have shown an incidence rate of diarrhoea ranging from % to %. it may precede or trail the respiratory symptoms [ ] . increasing evidence indicates possible faecal-oral transmission [ ] [ ] [ ] . other gastrointestinal symptoms are nausea and vomiting, abdominal pain, and loss of appetite [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] (figure ). less common symptoms include sore throat, headache, nasal congestion, hyposmia/anosmia, ageusia, diffuse aches and pains, and conjunctivitis [ ] . the most common skin manifestations associated with covid- infection include a maculopapular or papulovesicular rash, urticarious lesions, painful acral red purple papules, livedo reticularis, and petechial lesions. the most common areas involved are the trunk, hands and feet, with little itching experienced. these symptoms usually present before the onset of respiratory symptoms and spontaneously disappear within d in all patients. there is no demonstrated correlation, in the majority of the studies, between skin lesions and covid- severity [ ] [ ] [ ] . an italian paper reported skin manifestations of covid- in young patients, of whom were asymptomatic and potentially contagious. these lesions began as erythematous-violaceous patches in the acral sites and slowly evolved to purpuric and then to ulcero-necrotic lesions, followed by a complete "restitutio ad integrum" of tissues. burning and itching were present with some of the lesions [ ] . data provided by the who health emergency dashboard (may , , . am cest) indicated confirmed cases worldwide since the beginning of the epidemic, and in the last h. in total, cases were fatal, with in the last h [ ] . looking at these data, the global situation still appears to be in a dramatic evolution. trying to investigate the reasons why, in some patients, the covid- infection rapidly evolves into a severe acute respiratory syndrome, has led to multiple organ dysfunction and even death being a focus of primary importance. the largest cohort of patients with covid- from china (more than , ) showed that illness severity can range from mild ( %) to severe and critical ( % and % respectively), as shown in table [ ] . mild covid- illness is characterized by a lower respiratory disease, evidenced by clinical assessment or imaging, and with blood o saturation level of > % on room air at sea level. these patients should be admitted to a healthcare facility for close observation. covid- severe illness is defined by a blood o saturation level of ≤ % on room air at sea level, respiratory rate of > , arterial partial pressure of o /fraction of inspiration o of ≤ mmhg, or lung infiltrates of > %. these patients may experience rapid clinical deterioration into a critical disease state. the clinical picture of critical patients with severe inflammatory-induced lung disease and with sepsis or septic shock needing intensive care support and mechanical ventilation is characterized by a wide range of signs and symptoms of life-threatening multiorgan dysfunction or failure, including dyspnoea, tachypnoea (respiratory rate of > /min), tachycardia, chest pain or tightness, hypoxemia, virus-induced distributive shock, cardiac dysfunction, elevations in multiple inflammatory cytokines, renal impairment with oliguria, altered mental status, functional alterations of organs expressed as laboratory data of hyperbilirubinemia, acidosis [serum lactate level > mmol/l ( mg/dl)], coagulopathy, and thrombocytopenia. moreover, an exacerbation of underlying comorbidities is often possible [ ] [ ] [ ] [ ] [ ] [ ] [ ] . old-age patients with pre-existing comorbidities or dyspnoea should be hospitalized and closely monitored, especially at - wk after symptom onset. in fact, as already mentioned, in patients with other pre-existing diseases, covid- may be fatal [ , [ ] [ ] [ ] . the sequential organ failure assessment (commonly known as sofa) score is used for the evaluation of multiorgan damage and to predict icu mortality risk based on lab results and clinical data [ , ] , as well as for validation in a paediatric version [ ] . a kawasaki-like disease -a vasculitis for which diagnosis is based on the presence of persistent fever, polymorphic rash, lymphadenopathy, conjunctival injection, changes to the mucosa, swollen extremities and with coronary artery aneurysms as its main complication -has been described in children infected with covid- , with a monthly incidence much more higher than observed for kawasaki disease across the previous years. there was also a high proportion of shock in those children presenting with hypotension and requiring fluid resuscitation and some needing inotropic support. it is still uncertain, however, if this emerging phenomenon is a kawasaki disease type, with sars-cov- as the triggering agent, or if it represents an emerging kawasaki-like disease characterized by multisystem inflammation [ ] [ ] [ ] . current studies are investigating the relationship between different variables and the risk of death of covid- patients hospitalized for pneumonia. the pulmonary imaging techniques for diagnosis of covid- lung damage include an initial evaluation with chest x-ray, ultrasound, and, if indicated, computed tomography. electrocardiogram should be performed if indicated, especially in patients with september , volume issue cardiovascular risk factors. laboratory testing includes a complete blood count with differential and a metabolic profile, including liver and renal function tests. a chinese sex-, age-and comorbid illness-matched case-control study identified lymphopenia (cd + cd + tcells ≤ cells· μl - ) and cardiac troponin i value of ≥ . ng· ml - as negative prognostic factors associated with an increase in risk of mortality from covid- pneumonia [ ] . many studies have designed different increased laboratory results as early predictors of critical illness, such as leucocytosis with agranulocytosis, elevated lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, bilirubin, creatine phosphokinase, myoglobin and cytokines [i.e., interleukin (il)- , il- , il- , granulocyte colony-stimulating factor, interferon gamma-induced protein , monocyte chemoattractant protein- , macrophage inflammatory protein- alpha, and tumour necrosis factor-alpha]. although, these findings remain to be validated by further studies. measurements of inflammatory markers such as c-reactive protein, ddimer, and ferritin, while not part of standard care, may have prognostic value [ ] [ ] [ ] . during infectious disease outbreaks, triage is particularly important to separate patients likely to be infected with the pathogen of concern. the cdc has released comprehensive guidelines for management of patients with covid- , including those who are critically ill [ ] . it would be very important to make hotlines available that patients can call to notify the facility that they are seeking care and which can be used as telephone consultation for patients to determine the need to visit a healthcare facility; through this, patients could be informed, before arriving for triage, of preventive measures to take as they come to the facility (e.g., wearing a mask and having tissues to cover cough or sneeze). moreover, healthcare facilities should consider telemedicine (e.g., cell phone videoconference or teleconference) to provide clinical support without direct contact with the patient [ ] . emergency departments should have a "respiratory waiting area" for patients coming in with respiratory symptoms (suspected covid- patients), with clear signage at the entrance, physical barriers (e.g., glass or plastic screens) installed to limit close contact between registration desk personnel and potentially infectious patients. a facemask should be given to patients with respiratory symptoms as soon as possible, if they do not already have one. the number of accompanying family members in the waiting area should be limited. dedicated clinical staff (e.g., physicians or nurses) should be assigned for physical evaluation of patients presenting with respiratory symptoms at triage. these staff should be trained on triage procedures, covid- case definition, and appropriate personal protective equipment (commonly referred to as ppe) use (e.g., mask, eye protection, gown, and gloves) [ ] . all the hospital staff (healthcare workers, lab technician, cleaners) and visitors must protect themselves and others by correctly using the ppe and respecting standard precautions, which will include performing hand hygiene frequently (with an alcohol-based hand rub if your hands are not visibly dirty or with soap and water if hands are dirty), contact and droplet precautions, selection of ppe-based risk assessment (e.g., n respirators or powered, air-purifying respirators rather than a surgical mask, eye protection such as face shield or goggles, gowns, simple gloves or heavy-duty gloves, and boots or closed work-shoes), cleaning, disinfection and injection safety practices, and single-patient dedicated medical equipment (e.g., stethoscopes, blood pressure cuffs, and thermometers) [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the confirmed cases must be hospitalized, possibly in single, isolated rooms with negative air pressure as well as a dedicated bathroom and anteroom. if not possible, the confirmed cases must be, in any case, hospitalized in a single room with a dedicated bathroom and transferred as soon as possible to a safe structure. confirmed covid- patients may be hosted in the same room. if available, airborne infection isolation rooms should be used. covid- patients are often very complex and require a multidisciplinary medical team which includes at least the following specialists: emergency doctor, pulmonologist, infectious disease specialist, critical care physician, and medical laboratory technician [ ] [ ] [ ] . a first approach during triage is using the quick-sofa (commonly referred to as the qsofa) for a rapid identification of high-risk septic covid- patients [ , ] . the american disease cdc recommends some criteria priorities for testing patients with suspected covid- , as shown in september , volume issue table . for initial diagnostic testing for sars-cov- , the cdc recommends collecting and testing an upper respiratory specimen (nasopharyngeal/oropharyngeal swab collected by a healthcare professional) for a rapid molecular in vitro diagnostic test, utilizing an isothermal nucleic acid amplification technology intended for the qualitative detection of nucleic acid from the sars-cov- viral rna (real-time reverse transcriptasepolymerase chain reaction) [ , ] . testing lower respiratory tract specimens is also an option. for patients who develop a productive cough, sputum should be collected and tested for sars-cov- . the induction of sputum is not recommended. when under certain clinical circumstances (e.g., those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronco-alveolar lavage sample should be collected and tested as a lower respiratory tract specimen [ , ] . plasma cells take at least - d to develop antibodies against covid- . for this reason, serological tests are not sensitive enough to accurately diagnose a recent infection, even in symptomatic patients. clinical recovery has been correlated with the detection of igm and igg antibodies, which signal the development of immunity. actually, there are no data concerning the possibility of reinfection after recovery from covid- . viral rna shedding declines with resolution of symptoms and may continue for days to weeks. however, the detection of rna during convalescence does not necessarily indicate the presence of viable infectious virus [ ] [ ] [ ] . optimal management of covid- is evolving quickly and treatment guidelines based on scientific evidence and experts' opinions with clinical experience are updated frequently. until now, there are no food and drug administration (fda)-approved drugs for covid- and no vaccine is currently available (even if there are many experimental trials, such as the vaccine promoted by the united states' biotech firm moderna); hence, infected people primarily rely on symptomatic treatment and supportive care [ ] . meanwhile, an array of drugs approved for other indications as well as multiple investigational agents are being studied for the treatment of covid- in several hundred clinical trials all over the world. patients with severe infection are currently being treated with o therapy. patients with viral pneumonia, hypoxemic respiratory failure/acute respiratory distress syndrome, sepsis and septic shock, cardiomyopathy and arrhythmia, and/or acute kidney injury often require noninvasive or mechanical ventilation and support in the icu. hemodynamic support is essential for managing septic shock. hospitalization is also fundamental for the management of complications from prolonged hospitalization itself, including secondary bacterial infections, thromboembolism, gastrointestinal bleeding, and critical illness polyneuropathy/myopathy [ ] [ ] [ ] [ ] . at present, the national institutes of health covid- treatment guidelines do not recommend the use of any agents for pre-exposure prophylaxis and post-exposure prophylaxis against sars-cov- outside of the setting of a clinical trial, because no drug has actually been proven to be safe and effective for treating covid- [ ] [ ] . moreover, no specific treatment is also recommended for persons with suspected or confirmed asymptomatic or pre-symptomatic covid- infection. to help reduce fever and diffuse aches related to covid- infection, either acetaminophen or ibuprofen can be prudently used, without exceeding the recommended dose per day of mg [ , ] . most of the recommendations for the management of severely and critically ill patients with covid- are extrapolated from experience with other lifethreatening infections and they do not deviate substantially from the management of other patients with severe diseases; although, special precautions in this infectious disease are required. these measures include high-flow nasal oxygen and noninvasive ventilation in non-severe forms of respiratory failure, while intubation and protective mechanical ventilation are required in severe forms. prone position ventilation and extracorporeal membrane oxygenation have been used many times for very acute patients with refractory hypoxemia despite lung-protective ventilation [ ] . systemic corticosteroids and inappropriate administration of antibiotics are not recommended for the viral pneumonia's treatment, although some centres recommend it but only in case of evidence of bacterial infection [ , , ] . although no antiviral treatments have been approved, several approaches have been proposed to limit viral reproduction, particularly drugs that have been used to treat malaria and autoimmune diseases and already used against past outbreaks, including those of sars-cov and mers-cov. these include antiviral drugs, such as lopinavir, ritonavir, nelfinavir, and remdesivir. the last one is an inhibitor of rna polymerase with in vitro activity against multiple rna viruses [ ] . alpha-interferon ( e.g., million units by aerosol inhalation twice per day), chloroquine ( mg every h), and hydroxychloroquine ( mg every h) are also used. chloroquine was introduced in clinical practice in to treat malaria, while hydroxychloroquine was introduced in and prescribed for the treatment of systemic lupus erythematosus [ ] . the efficacy for systemic lupus erythematosus is based on the capability of this drug to inhibit toll-like receptor signalling and to reduce cytokine production, especially that of il- and il- . starting from this consideration, hydroxychloroquine, and thereafter chloroquine, has been proposed as a helpful treatment for covid- patients, in which some reports showed a direct antiviral effect in vitro due to an interference with ace- receptors [ ] . chloroquine and hydroxychloroquine, which are not fda approved for covid- , are available from the strategic national stockpile for hospitalized adults and adolescents (weighing ≥ kg) under an emergency use authorization [ , , ] . there has been supposition (never proven) that azithromycin may help to reduce the overactive immune response to the sars-cov- infection that otherwise causes inflammatory damage. unfortunately, the most recent human studies suggest no benefit and a strong statement was released, advising against the use of the combination of hydroxychloroquine and azithromycin, underlying the higher risk of death due to lethal heart arrhythmias with both hydroxychloroquine and azithromycin are used alone and especially when used in combination. in fact, it is well known that hydroxychloroquine and, moreover, chloroquine may have several side effects on the extrapyramidal, cardiovascular and digestive systems, which are more severe if associated with other medications (i.e. haemolysis with dapsone, severe hypoglycaemic effects with anti-diabetics, qt elongation, or torsades de pointes with ciprofloxacin and other antimicrobials, etc.) [ ] [ ] [ ] . however, to date, this issue remains controversial [ ] . tocilizumab, a humanized igg monoclonal antibody directed against the il- receptor and commonly used in the treatment of rheumatoid arthritis, has already been used in a rhesus macaque model of mers-cov infection and is currently being used in experimentations against covid- . two chinese large randomized clinical trials, which enrolled over patients and other studies which are also underway in european countries and in the united states are likely to definitively answer the question of whether the drug is effective in treating covid- , and so it could be approved for use and produced in large amounts [ ] . september , volume issue on march, , the fda allowed convalescent plasma from recovered patients to be used in patients with serious or immediately life-threatening covid- infections. these antibody-containing plasma, in many cases, showed the intended effect in fighting the illness, shortening the length or reducing the severity of the disease, but this treatment is still considered experimental and more randomized, controlled studies must be done to test its efficacy and safety. it has been estimated that herd immunity against covid- (that is, an indirect protection given by recovered patients to those who are not immune to the disease) is around % to . % [ ] . moreover, covid- patients show a contemporary hypercoagulation and hypofibrinolytic state due to dysregulation of the coagulation and fibrinolytic systems, with elevated d-dimer and fibrinogen and deposition of fibrin in the air spaces and lung parenchyma caused by the activated tissue factor exposure on damaged alveolar endothelial cells and on the surface of leucocytes. the patients also show significantly elevated levels of plasminogen activator inhibitor released from lung epithelium and endothelial cells. prophylaxis treatment with low molecular weight heparin is considered important to limit covid- patients' coagulopathy, but, at the same time, it is fundamental to degrade pre-existing fibrin in the lung by promoting local fibrinolysis with tissue-type plasminogen activator as intravenous thrombolytic treatment. its nebulizer form is currently in phase ii clinical trial and may provide a targeted approach in covid- patients to degrade fibrin and improve oxygenation in critically ill patients [ ] . new research fields are concerned with the use of immuno-enhancers (interferons, thymosin α- , thymopentin, levamisole, cyclosporine a), vitamins (a, b, c, d, e), alipoic acids, minerals (selenium, zinc, iron), omega- polyunsaturated fatty acids, nacetylcysteine and d-ribose-l-cysteine, probiotics, and the intravenous infusion of allogeneic expanded umbilical cord mesenchymal stem cells that show antiviral and antimicrobial properties, and which must be deepened. the italian college of anesthesia, analgesia, resuscitation and intensive care have reported guidelines to use these cells in covid- patients, in the hope of decreasing the number of patients going to the icu, and also getting them out of icu relatively quickly [ , ] . despite this, there are insufficient data to recommend either for or against the use of any antiviral or immunomodulatory therapy in patients with covid- who have mild, moderate, severe, or critical illness [ ] . researchers are carrying out incessant efforts towards understanding these topics, including on translational regenerative approaches, such as mesenchymal stem cells [ , ] . the sars-cov- pandemic is a serious health problem and a challenge of global concern. during these months, we've had to learn, step-by-step, all about this novel coronavirus, ranging from its origins (which are still uncertain) to its mode of transmission, identifying people most at risk, and searching for old and new strategies which could help patients in fighting against this invisible enemy. still, despite this, even more studies are needed to provide more effective preventive measures and treatment policies and to determine what is the proper social behaviour in public places and the rules of conduct for healthcare professionals' management and resource planning; ultimately, the collective knowledge will lay a solid foundation for winning the battle against this epidemic. world health organization. pneumonia of unknown cause -china rapid progression to acute respiratory distress syndrome: review of current understanding of critical illness from covid- infection what we know so far: covid- current clinical knowledge and research diarrhea during covid- infection: pathogenesis, epidemiology, prevention, and management the occurrence of diarrhea in covid- patients covid- and the digestive system coronavirus disease (covid- ) pandemic burst and its relevant consequences in dental practice comment to the article "olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (covid- ): a multicenter european study calzavara-pinton p. varicella-like exanthem as a specific covid- -associated skin manifestation: multicenter case series of patients cutaneous manifestations of covid- : report of three cases and a review of literature cutaneous manifestations in covid- : a first perspective silent covid- : what your skin can reveal world health organization. coronavirus disease (covid- ) situation report- characteristics of and important lessons from the coronavirus disease (covid- ) outbreak in china: summary of a report of   cases from the chinese center for disease control and prevention covid- -what should anaethesiologists and intensivists know about it? current issues and perspectives in patients with possible sepsis at emergency departments new criteria for sepsis-induced coagulopathy (sic) following the revised sepsis definition: a retrospective analysis of a nationwide survey derivation, validation, and potential treatment implications of novel clinical phenotypes for sepsis the preoperative inflammatory status affects the clinical outcome in cardiac surgery adaptation and validation of a pediatric sequential organ failure assessment score and evaluation of the sepsis- definitions in 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antioxidant and disulphide breaking agent: the reasons why a successful history: probiotics and their potential as antimicrobials current status of potential therapeutic candidates for the covid- crisis mesenchymal stem cells as promoters, enhancers, and playmakers of the translational regenerative medicine expanded umbilical cord mesenchymal stem cells (uc-mscs) as a therapeutic strategy in managing critically ill covid- patients: the case for compassionate use key: cord- - i bmnee authors: dean, elizabeth; jones, alice; yu, homer peng-ming; gosselink, rik; skinner, margot title: translating covid- evidence to maximize physical therapists’ impact and public health response date: - - journal: phys ther doi: . /ptj/pzaa sha: doc_id: cord_uid: i bmnee coronavirus disease (covid- ) has sounded alarm bells throughout global health systems. late may, , over , covid- related deaths were reported in the united state, the highest number of any country. this article describes covid- as the next historical turning point in the physical therapy profession’s growth and development. the profession has had over a -year tradition of responding to epidemics including poliomyelitis; two world wars and geographical regions experiencing conflicts and natural disasters; and the epidemic of noncommunicable diseases (ncds). the evidence-based role of non-invasive interventions (non-pharmacologic/non-surgical) that hallmark physical therapist practice has emerged as being highly relevant today in addressing covid- in two primary ways. first, despite some unique features, covid- presents as acute respiratory distress syndrome (ards) in its severe acute stage. ards is well familiar to physical therapists in intensive care units. body positioning and mobilization, prescribed based on comprehensive assessments/examinations, counter the negative sequelae of recumbency and bedrest; augment gas exchange and reduce airway closure, deconditioning and critical illness complications; and maximize long-term functional outcomes. physical therapists have an indisputable role across the covid- care continuum. second, over % of individuals who contract and die from covid- have co-morbidities, most notably cardiovascular disease, hypertension, chronic lung disease, type diabetes mellitus, and obesity. physical therapists need to redouble their efforts to address ncds by assessing patients for risk factors and manifestations and institute evidence-based health education (smoking cessation, whole-food plant-based nutrition, weight control, physical activity/exercise), and/or support patients’ efforts when these are managed by other professionals. effective health education is a core competency for addressing risk of covid- as well as ncds. covid- is a wake-up call to the profession, an opportunity to assert its role throughout the covid- care continuum and augment public health initiatives by reducing the impact of the current pandemic. for over years in industrialized countries, physical therapists have specialized in human movement and functioning irrespective of disease and its severity (from the community to the icu) and chronic disability. it has become the third largest established health profession in the world, excepting dentists and pharmacists who have distinct practice patterns. physical therapy has been largely hallmarked by its non-invasive approaches, ie, non-pharmacological and non-surgical approaches, and competencies, and has applied this perspective through a history of responding to epidemics including poliomyelitis, two world wars and geographical regions experiencing conflicts, wars and natural disasters, and most recently ncds. the profession has emerged from a tradition of applying passive interventions to maximize movement and function, to a more holistic comprehensive tradition of exploiting means of maximizing overall health and wellbeing to augment movement and function. throughout its history, the physical therapist profession has correspondingly responded in terms of maximizing people's health and function by exploiting non-invasive interventions to the because of this, the icf has been supported by the world confederation for physical therapy (wcpt) and its member organizations. this was another turning point that advanced patient assessment, evaluation and examination to include broad dimensions beyond limitations of structure and function, to activity and participation, and assessment of contextual factors such as the patient's environment and personal factors including lifestyle behaviors. all the while, the research intensity of the profession has been unprecedented and has grown exponential over the past years in terms of securing competitive grant monies and publishing in high-ranking peer-reviewed journals. about % of covid- cases are mild and may even be undetected. ten percent of those the physical therapy community has responded expediently with the publication of practice guidelines for the acute management of patients with covid- . [ ] [ ] [ ] these guidelines and recommendations largely build on the position statement for physical therapy for adults with critical illness published in . however, that patients in the icu generally do not do well months, often years, after post-icu discharge has reinforced the notion that the continuum of care including physical therapy needs to extend for months afterwards. [ ] [ ] [ ] with the association of comorbidities, ie, ncds, with increased susceptibility to covid- and poorer outcomes including survival, has been well documented. , given the prevalence of ncds in the united states and increasingly around the world, most people have one or more risk factors or manifestations, which makes them vulnerable to covid- infection. this being the era of ncds, physical therapists have long been urged to exploit lifestyle and behavioral medicine competencies, to reverse ncds and their risk factors, eg, atherosclerosis, smoking, hypertension, type diabetes mellitus and obesity, often within days or weeks, and atherosclerosis within one year or more. , in the united states, % of those who have succumbed to covid- have at least one comorbidity, primarily related to lifestyle-related ncds; in italy this figure is %. only in americans engage in or more healthy behaviors, whereas almost half of them participate in fewer than healthy behaviors. increased participation in numerous healthy behaviors can decrease premature mortality, decrease the burden of chronic diseases, improve life quality, and provide substantial economic benefits. thus, reducing such susceptibility is critical. improving lifestyle behaviors has been well documented to prevent, reverse, as well as manage ncds. a public health practice of targeting a constellation of behaviors as opposed to individual behaviors is needed. , smoking, sedentary behavior, physical inactivity, and obesity are an independent risk factors for metabolic syndrome, - as well as cardiovascular disease, and all associated with elevated markers of low grade systematic inflammation. consistent with the recent report of the lancet eat commission, the american college of lifestyle medicine advocates a whole-food plant-based nutrition to maximize health, prevent disease particularly ncds, reverse these conditions, and reduce disability, premature death and socioeconomic burdens associated with them. such a dietary regimen has been well established to reduce risk of heart disease, cancer, high blood pressure, type diabetes, and obesity, and their relative, metabolic syndrome, conditions unequivocally linked to more severe covid infections and poorer outcomes including death. in some instances, such as hypertension and elevated blood glucose, these can be reduced within days or weeks. atherosclerosis can also be reduced or resolved with dietary changes and exercise, however these effects can take many months. , overweight can be addressed with a healthy plantbased nutrient-dense diet and exercise. variations in host immune responses might be explained in large part by the healthfulness of the host's lifestyle and behavioral factors including nutritional choices. thus, immune responses to covid- and mechanisms of hyperinflammation-driven pathology warrant elucidation to best define therapeutic strategies for covid- , including nonpharmacologic strategies such as healthy nutrition and exercise. a secondary gain of healthy nutrition could be lower incidence of physical impairment, irrespective of body mass. effective health and lifestyle education are unique physical therapist competencies. as the leading established non-invasive health profession in the world, the profession needs to assume a leadership role with respect to including in their practices and entry-level education curricula, health and risk factor assessment and prescribing health promoting interventions or indications for referral to others. effective health and lifestyle education, ie, lifestyle knowledge translation, warrants being ever more so at the forefront of every physical therapist-patient interaction. at a broad level, the physical therapy profession needs to ensure that health providers and stakeholders continue to be updated about the profession and practitioners' competencies as the professions continues to evolve and serve global societies. this will ensure that stakeholders such as legislators, ministries of health and higher education, hospital managers, university administrators, and other health professions, continue to support the physical therapy profession in its practicing at its highest evidence-informed level, in the interest of health and participation for all. the unprecedented global crisis of covid- has become an unprecedented opportunity for the physical therapist profession to continue to advance along its evolving historic trajectory, commensurate with societal and global needs. the profession has an opportunity to respond impactfully. we conclude that the covid- pandemic could well augment the profile of the profession of physical therapy within the health professions and within public health, given its potential role in reducing covid- susceptibility, and its management from its most severe expression, ards, to maximizing functional return long after hospital or icu stays. prevention and outcome of covid- could be substantially impacted with exploitation of non-invasive strategies including health and lifestyle education and exercise, that are subsumed within contemporary physical therapist practice. this is an unparalleled opportunity for the physical therapist profession to step up to the plate, and to further establish itself among the health professions and demonstrate its worth. there is no funding to report. accessed june . . and reduce the burden of non-communicable diseases postmortem examination of patients with covid- endothelial cell infection and endotheliitis in covid- post-discharge cardiac care in the era of coronavirus : how should we prepare? world health organization. covid- significantly impacts health services for noncommunicable diseases cardiovascular and pulmonary physical therapy: evidence to practice ( th ed) long-term complications of critical care rehabilitation quality improvement in an intensive care unit setting: implementation of a quality improvement model long-term outcomes and healthcare 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disclosure of potential conflicts of interest and reported no conflicts of interest. key: cord- -bp q plt authors: zhang, yuan; wang, shu; ding, wei; meng, yao; hu, huiting; liu, zhenhua; zeng, xianwei; guan, yuguang; wang, minzhong title: status and influential factors of anxiety depression and insomnia symptoms in the work resumption period of covid- epidemic: a multicenter cross-sectional study date: - - journal: j psychosom res doi: . /j.jpsychores. . sha: doc_id: cord_uid: bp q plt objective: in this study, the authors analyzed the status of anxiety depression and insomnia symptoms and influential factors in the work resumption period of coronavirus disease (covid- ). methods: a multicenter cross-sectional survey was conducted from march , to march , in shandong province, china, using quota sampling combined with snowball sampling. the generalized anxiety disorder- (gad- ), the patient health questionnaire- (phq- ), and the insomnia severity index (isi) were used to assess the anxiety, depression, and insomnia symptoms. the multivariate logistic regression analysis was used to explore the influential factors. results: a total of invitations were sent from three centers, valid questionnaires were received. based on gad- , phq- , and isi scales, . %– . % of the participants had anxiety, depression, or insomnia symptoms; . %– . % had severe symptoms. besides, . %, . %, and . % of the participants had anxiety-depression, anxiety-insomnia, or depression-insomnia combined symptoms. the scores of anxiety and insomnia symptoms, along with scores of depression and insomnia symptoms were positively correlated in these samples. aged – years and outside activities once in ≥ days were risk factors of anxiety, depression, and insomnia symptoms in common. during the epidemic, . % of the participants had received psychological interventions, and only . % had received individual interventions. conclusions: the incidence of psychological distress increased during the outbreak of covid- in the work resumption period than the normal period. current psychological interventions were insufficient; target psychological interventions should be conducted in time. the outbreak of coronavirus disease (covid- ) became a global health threat in early [ , ] . the covid- was highly infectious and fatal to some patients [ ] . so far, there was no specific remedy [ ] . to control the spread of covid- , the chinese government implemented a strict restriction on outdoor activities from the spring festival [ ] . by the late february , the epidemic was effectively controlled in mainland china [ ] . on february , , the state council of the p.r.c. published a guideline for the prevention and control of covid- during the work resumption period, which announced the permission of work resumption [ ] . as the epidemic has not been completely resolved [ ] , the work resumption procedure was gradually conducted and cross-regional activities were still restricted. the panic caused by the epidemic, the communication reduction caused by interpersonal isolation, and the economic impact caused by production suspension can trigger the stress response, which may induce psychological distress even mental illness [ ] [ ] [ ] [ ] [ ] . previous studies suggested that the severe acute respiratory syndrome (sars), the middle east respiratory syndrome (mers), and the ebola virus disease (ebola) epidemics had serious psychological influences to a wide range of people [ ] [ ] [ ] . it is necessary to conduct target psychological intervention timely and effectively to prevent psychological distress from worsening. although previous studies conducted some investigations of the psychological status during the outbreak of covid- , there was limited analysis of the psychological status and influential factors in the work resumption period [ , , ] , and this is a global research gap for covid- research [ ] . in the work resumption period, the present study consisted of a pre-investigation and a formal investigation. the pre-investigation was launched from february , (next week after the permission of work resumption [ ] ) to february , . the objectives of the pre-investigation were to foster multicenter collaboration, to assess sampling procedure, to examine the accessibility of the questionnaire, and to determine the sample size of the formal investigation. the three collaboration centers sent a total of invitations ( for each center) and received ( . %) valid questionnaires. the proportion of participants with anxiety, depression, or insomnia symptoms was . - . %. based on the pre-investigation, the permissible error was set as . and the drop-out rate was set as . %. the clopper-pearson formula for two-sided confidence intervals for one proportion was used to determine the sample size. after calculation in pass software (ncss llc., kaysville, utah, usa; version ), the desired dropout-inflated enrollment sample size was . the number of invitations sent in the formal investigation was set as . the official investigation was performed from march , , to march , . as cross-regional outside activities were still restricted, it was impossible to conduct a random sampling procedure by investigating from house to house. a population-based representative quota sampling method combined with a snowball sampling method was designed. first, the proportion of the population in each region was determined according to the census of shandong province (published in , data as of the end of ) [ ] . the quotas for invitations sent was based on the proportion of population in these three regions (western region (western center): n = ; middle region (middle center): n = ; eastern region (eastern center): n = ). second, a cross-control quota sampling procedure for characteristics of the population (subregion, age, gender, occupation) in each region was conducted. third, based on online unified questionnaire or a telephone survey (for people who cannot answer online, such as elderly; the content is consistent with the online questionnaires). all participants were required to answer only once through one review method. a detailed description of the similar sampling method has been published elsewhere [ ] . figure shows the sampling process. the questionnaire consisted of three parts. the first part collected characteristics, (public, individual). the third part was standardized scales, including gad- , phq- , and isi, to assess anxiety, depression, and insomnia symptoms. participants were required to respond based on the experiences of the past two weeks. the suitable classification standards of these three scales were determined by the chinese consensus reviewed by psychologists. the gad- , phq- , and isi score ≥ , , indicate anxiety, depression, and insomnia symptoms; scores ≥ , , indicate severe anxiety, severe depression, and severe insomnia symptoms. for participants aged under , total scores ≥ points in phq- is consider to have depression symptoms [ ] . at the end of the questionnaire, a trust question was set as "did you answer truthfully". questionnaires with "no" response in the trust question, the all statistical analyses were performed using the spss software package (ibm, armonk, new york, usa; version ). the influential factors of anxiety, depression and insomnia symptoms were analyzed by logistic regression. the division of ages was consistent with the chinese epidemiology study of mental disorders by huang et al. [ ] in the normal period and the cross-sectional study of psychological status by wang et al. [ ] in the outbreak of covid- to set as contracts. variables showing a p-value of < . in the univariate analysis (pearson x or fisher exact test) were then entered into a multivariate logistic regression analysis with a backward method. the or value and its % confidence interval ( %ci) were given for independent factors, and the or value > indicated risk factors. besides, after the gad- , phq- , and isi scores of the participants were tested for normality (kolmogorov-smirnov test), pearson's correlation analysis was performed to explorer the correlation of scores. a p value of < . was considered statistically significant. table shows the participants' characteristics and experiences related to the covid- epidemic. according to the gad- , phq- , and isi scales, . % ( ) table . ). the wildly spread covid- epidemic and strict interpersonal isolation can trigger stress response [ ] . the occurrence of stressful life events is a risk factor for psychopathology, and environmental stressors also induce stable changes in gene expression within the brain that may lead to mental illnesses [ , ] . coming into the work resumption period, many factors can become stressors of a wide range of people in a comprehensive effect, including epidemical panic, interpersonal isolation, economic volatility, and resumption status. the present study revealed that resumption period than the normal period. an online survey [ ] and another study on chinese web users [ ] suggested that one-third of people had anxiety symptoms during the outbreak of covid- and the negative emotion increased. but they only focused on web users, which might limit their overall representation. a previous nationwide cross-sectional study of the research team was conducted from february , to february , (during the outbreak of covid- ) in china with a similar design of the present study. they proposed . %, . %, and . % of the participants had anxiety, depression, or insomnia symptoms. the proportion of anxiety, depression, and insomnia symptoms got increased the present study [ ] . wang et al. besides, the present study also showed that . %, . %, and . % of participants had anxiety-depression, anxiety-insomnia, or depression-insomnia combined symptoms. the scores of anxiety and insomnia symptoms (r = . ), along with scores of depression and insomnia symptoms (r = . ) were positively correlated in these samples. previous studies suggested that environmental stressors or physiological disease might cause the comorbidity of anxiety, depression, or insomnia, which could provide a great challenge in the diagnosis and intervention [ , ] . the comorbidity of anxiety and depression could make psychological distress worse and reduce treatment response, which should be considered [ ] . sleep disturbance is a common manifestation of anxiety and depression. insomnia has been identified as a predictor of multiple mental disorders and could increase the risk for psychopathology [ ] . efforts should be made to strengthen interventions for sleep problems such as cognitive behavior therapy and mindfulness-based therapy [ ] . this study also analyzed the risk factors for anxiety, depression, and insomnia according to an epidemiological study of mental disorders, chinese aged - years had a higher incidence of mental illness than the other age groups [ ] , which may explain the higher prevalence of anxiety, depression, and insomnia symptoms in participants aged - years in the present study. furthermore, in china, many middle-aged and elderly people are in leadership positions in companies and families. the economic stress caused by the epidemic and work resumption could influence their mental health [ ] . therefore, middle-aged and elderly people, especially aged - years, are easier to have psychological distress that needs interventions. in addition, the previous study of wang et al. suggested participants aged - years had more severe anxiety, depression, and insomnia symptoms during the outbreak of covid- [ ] . this change in the high-risk age groups might be the combined influence of economic and epidemic pressure changes with time, which needs further exploration. affected by the covid- epidemic, a wide range of people reduced unnecessary outside activities and interpersonal communication, some of them even stayed home alone for a long time. in the present study, . % of the participants had outside activities once in ≥ days. previous studies suggested that the interpersonal isolation of patients had a significant impact on mental health [ ] . with further control of covid- , more and more people can restore interpersonal contacts and resume normal work in the future. the psychological distress may get released in some people. however, interpersonal isolation has a long-term influence on mental health, some people with psychological distress cannot relieve by himself, even after resuming interpersonal contacts [ ] . target psychological interventions should be performed in time to people under long-term interpersonal isolation before and after work resumption. in addition, several previous studies concerned the healthcare workers had a higher risk of psychological symptoms [ , , ] . the present study did not find being frontline medical staff was a risk factor of psychological distress, which might relate to the effectively control of the epidemic, lower proportion of confirmed patients, higher proportion of accepting psychological interventions for these group, and higher proportion of recovering patients. however, more attention in the present study, only . % of current participants had received psychological interventions, . % had received individual psychological interventions during the outbreak of covid- . compared with a previous study ( . % received counseling during the outbreak) [ ] , the proportion of people received psychological interventions got a great increase. but it was still insufficient for the potential proportion of people with psychological distress. the outbreak of covid- limited face-to-face counseling and individualized psychological interventions, which was a serious challenge to the mental health service. besides, there were still many people who did not pay enough attention to mental health [ ] . irvine et al. suggested that there was no significant difference between online or telephone psychological therapy and face-to-face psychological intervention in efficacy and detrimental effects [ ] . besides, community interventions by internet or telephone and app-supported smartphone interventions also showed advantages in promoting mental health [ , ] such as internet-based cognitive behavior therapy [ ] . however, some studies concerned that non-face-to-face psychological interventions might have defects in reliability and individualized treatment [ , ] . we suggest that under the current circumstances, individualized psychological interventions are still important for high-risk groups, and the others should adopt public psychological education. as the outbreak of covid- has not been completely resolved, online or telephone interventions can be chosen as preferred. when the epidemic is under control, individualized face-to-face psychological interventions should be resumed in time to adjusted for all other variables. phq- : the patient health questionnaire- ; * p < . (multivariate logistic regression); ** p < . (multivariate logistic regression). adjusted for all other variables. isi: the insomnia severity index; * p < . (multivariate logistic regression); ** p < . 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kittelsen, sonja k title: cuba y seguridad sanitaria mundial: cuba’s role in global health security date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: umlqh q cuba has been largely absent in academic and policy discourse on global health security, yet cuba’s history of medical internationalism and its domestic health system have much to offer contemporary global health security debates. in this paper, we examine what we identify as key traits of cuban health security, as they play out on both international and domestic fronts. we argue that cuba demonstrates a strong health security capacity, both in terms of its health systems support and crisis response activities internationally, and its domestic disease control activities rooted in an integrated health system with a focus on universal healthcare. health security in cuba, however, also faces challenges. these concern cuba’s visibility and participation in the broader global health security architecture, the social controls exercised by the state in managing disease threats in cuban territory, and the resource constraints facing the island—in particular, the effects of the us embargo. while cuba does not frame its disease control activities within the discourse of health security, we argue that the cuban case demonstrates that it is possible to make strides to improve capacity for health security in resource-constrained settings. the successes and challenges facing health security in cuba, moreover, provide points of reflection relevant to the pursuit of health security globally and are thus worth further consideration in broader health security discussions. ► debate on global health security has focused on how we collectively respond to outbreaks, including what role and responsibility states have in supporting response efforts to health crises beyond their borders, and in strengthening domestic public health capacities to detect and contain disease risks. ► cuba's history of medical internationalism and its domestic disease prevention and control activities speak directly to these debates; yet, cuba is largely absent within global health security academic and policy discourse. cuba's international medical activities focused on routine health provision and crisis response, alongside its domestic disease control activities and universal health system demonstrate that cuba has a strong health security capacity. ► health security in cuba also faces challenges, however, particularly with respect to the trade-off between civil liberties, regime preservation and security in protecting the state and its population from diseases threats, and with respect to resource constraints, exacerbated by the us embargo. ► cuba does not frame its disease control activities within a discourse of health securitywhich impacts cuba's visibility and participation in the global health security regime. cuba demonstrates that it is possible to make strides to improve capacity for health security in resource-constrained settings facing multiple challenges, although within a particular political context where social controls exercised by the state raise questions of civil liberties. ► the successes and challenges that characterise cuba's health security activities speak to broader global health security debates and are thus worth engaging with more explicitly in contemporary health security discourse and practice. cuba has been largely absent in academic and policy discourse on global health security, yet cuba's history of medical internationalism and its domestic health system have much to offer contemporary global health security debates. in this paper, we examine what we identify as key traits of cuban health security, as they play out on both international and domestic fronts. we argue that cuba demonstrates a strong health security capacity, both in terms of its health systems support and crisis response activities internationally, and its domestic disease control activities rooted in an integrated health system with a focus on universal healthcare. health security in cuba, however, also faces challenges. these concern cuba's visibility and participation in the broader global health security architecture, the social controls exercised by the state in managing disease threats in cuban territory, and the resource constraints facing the island-in particular, the effects of the us embargo. while cuba does not frame its disease control activities within the discourse of health security, we argue that the cuban case demonstrates that it is possible to make strides to improve capacity for health security in resource-constrained settings. the successes and challenges facing health security in cuba, moreover, provide points of reflection relevant to the pursuit of health security globally and are thus worth further consideration in broader health security discussions. in the wake of this epidemic, academic and policy debate has turned to how the system for global health security can be reformed. [ ] [ ] [ ] this has included a focus on how national and global capacities can be enhanced to rapidly respond to health emergencies and how we can connect global health security activities to broader health system strengthening efforts, including the movement towards universal health coverage (uhc), as championed by who director-general tedros adhanom ghebreyesus. cuba's activities in global health security speak directly to these debates. indeed, cuba has made considerable strides in infectious disease control, comparable to that of high-income countries, doing so in a low-income setting beleaguered by a struggling economy, and facing resource and access challenges from the us embargo. these activities are embedded within a strong integrated health system, of which a key constituent part is preventative medicine (including vaccination for infectious disease) and uhc free at the point of care. through its work internationally, moreover, cuba has moved towards supporting sdg .d by assisting other countries in meeting their core capacities for surveillance and response for disease control. importantly for the global health audience, cuba demonstrates that it is possible to make strides to improve capacity for health security in resource-constrained settings facing multiple competing challenges, although this has been in a context of an authoritarian state where civil liberties have been questioned. given these achievements, it is interesting that cuba has not been referenced in broader global health security debates; yet cuba's lack of visibility in health security academic and policy discourse is noticeable. this could be attributed to cuba's isolation geopolitically, as a small island state, and given that the health security policy field has traditionally been western (us) dominated. the cuban government may not have wanted to engage in this debate, or been able to participate, based on political tensions, ideological differences and/or the us blockade of the island. alternatively, the geographical focus of health security discourse (and associated pragmatic efforts) has shifted temporally and geographically as the perception of 'next big one' has expanded from being focused solely on the threat of pandemic influenza in south-east asia to include haemorrhagic fevers in low-income and middle-income countries (lmics) in africa. cuba might have been absent from global health security narratives, similar to most of latin america, because it had not been prey to a major epidemic that has put its health system surge capacity in the spotlight. however, with the spread of zika across the caribbean and to cuba, despite the government's denial of the outbreak, this may not be an adequate explanation. we suggest a third consideration for the lack of cuban visibility in discussions of health security: that cuba does in fact demonstrate key traits which we understand to be health security, but it does so in the name of solidarity and part of a socialist project which seeks to export the strengths of the cuban regime internationally. we argue that health security is alive and well in cuba and offers insights into how we might strengthen health security globally, particularly in lmics which is vital to future preparedness efforts, although we consider these questions cautiously, recognising the particular political context in cuba and the trade-offs of civil and political liberties which come at the costs of such a strengthened health security position. to demonstrate our argument, we focus on what we consider the key traits of cuban health security, conceptualised as falling into two main categories: cuban medical engagements internationally, and cuban health provision domestically. we then consider some of the challenges for health security in cuba, notably the tension between providing complete security from the threat of disease and protecting civil rights within the state, and the impact of the us embargo on cuban health security, before reflecting on what we can learn from the cuban experience in improving health security globally. this paper uses a case study methodology to understand how cuba exhibits tendencies in global health security. the empirical material for this paper was drawn from a series of semistructured elite interviews conducted in havana in december with policymakers, medical professionals and other infectious disease control experts working in cuba. these data were subsequently transcribed, and thematic analysis was conducted to identify key trends that appeared in the qualitative material. we further undertook documentary analysis of policy documents from a range of sources, including the ministry of public health (minsap), cubacoopera (a government department responsible for medical internationalism) and the who/pan american health organization (who/paho), along with media sources both from cuba (granma) and internationally. these documents were sourced both in english and in spanish, and where necessary, translations are the authors' own. this material was triangulated against secondary literature including academic literature on health policy, international relations and cuban/latin american studies. these sources were identified through medline, google scholar and snowballing from these and international and cuban contacts. this latter step was important for two reasons: first, having undertaken interviews with policymakers from a one-party state that has worked hard to control information, we wanted to ensure that we were not solely reproducing the narrative that the cuban government wished us to voice, but that this was contextualised amid other research and findings within health and/or security analysis of the island. second, as hollander states, short-term research visits to socialist countries can be wholly misrepresentative, so we wanted to ensure that our findings were reflective of broader debates and narratives within the literature on the cuban health system. cuba's medical internationalism cuba's programme of medical internationalism has been well documented by latin-american scholars and anthropologists. [ ] [ ] [ ] [ ] medical internationalism involves sending medical brigades on missions abroad to offer routine health services, respond to crises as well as bringing medical students and patients back to cuba for education and/or treatment. we consider this to be the most apparent embodiment of cuban health security activities internationally, where the state appears to be supporting response efforts for emerging pathogens by providing human resources and technical expertise within outbreak response, and health systems capacity-building elsewhere in the world, such as the training of international medical professionals. particularly significant from the standpoint of global health security is the role that these cuban doctors, particularly the henry reeve brigade, have played in supporting responses to a number of epidemic outbreaks. brigades were deployed to el salvador, ecuador, nicaragua and honduras between and to support dengue fever response efforts. moreover, the cuban government was one of the first to respond to the ebola outbreak in west africa and its henry reeve brigade constituted the largest international bilateral support to arrive in the region. this stands in contrast to the criticism that the global community as a whole has faced for its delayed and inadequate response to the crisis. the cuban delegation, under who, was particularly involved in direct care to patients in ebola centre modi (liberia), kerry town and port loko (sierra leone) and supported the establishment of the coyah ebola treatment centre (guinea). to do so, cuban brigadistas received comprehensive training at the tropical medicine institute, instituto pedro kouri (havana), demonstrating the significant health security competency and capacity within cuba. this training included the use of personal protective equipment, biosecurity standards for patients and staff, treatment and diagnostic techniques, and risk scenario activity planning, and can now be used to launch a response to other diseases (interview, instituto de medicina tropical pedro kouri). more routinely, cuba deploys up to % of all its medical professionals to a number of non-crisis settings. this has involved medical teams totalling over health personnel, in over countries, including within the who and the g states. these cuban medical teams have tended to work in rural communities or in urban slums, areas that often have not had state medical provision prior to cuban arrival due either to an inability to recruit medical practitioners to live and work in these areas, or a lack of monetary motivation to establish provision where the local community has not been able to afford associated care costs, such as out-of-pocket payments. as routine access to health professionals facilitates the detection of diseases sooner, such activity can be considered to directly contribute to increased global health security, although notably this has not necessarily been the aim of any such brigade's mission. indeed, despite these efforts to support the development of health systems and respond to health crises, cuba does not frame these activities within the discourse of health security. rather, cuba's medical internationalism is framed as the embodiment of international solidarity and considered an extension of cuba's national health policy within the socialist framework. interviewees cited 'serving a global population' rather than protecting cuba's citizens against pathogen spread as reason for crisis interventions. recent media coverage of the closure of the mais medicos programme in brazil has focused on the political determinants of these overseas medical missions, where cuban doctors are sent to provide healthcare in exchange for oil or hard currency. political motivations have also been suggested as standing behind cuba's provision of over half of the medical professionals for mission barrio adentro in venezuela, chavez's (now failing) health and social welfare programmes focused on delivering universal healthcare across poorer neighbourhoods. such activities have spurred discussion on the motivation for this cuban international activity, whether driven by international prestige, goodwill, soft power, solidarity or economic gain. cuba's medical missions have also been criticised for violating the (labour) rights of those deployed. there is some suggestion, for example, that these doctors may not have autonomous decision-making regarding whether they want to deploy on these international missions, but rather are forced to do so by the government. recent legal proceedings in brazil, moreover, have sought to show that the cuban model of exporting physicians for economic gain violates the international labour organization's agreement on the protection of wages. this is based on the findings from the mais medicos programme that suggest that cuban medics received significantly less in wages than their international counterparts, with the majority of the wages paid directly by brazil to cuba for its doctors being retained by the cuban state. discussions about the profit-making nature of these overseas medical missions suggest that cuba's medical internationalism may be less about a notion of international solidarity or global health security, but rather functions as a form of income generation for the government within a failing economic system. in this respect, the contribution of these missions to global health security might be overegged and simply a by-product of government financing. nevertheless, we suggest that this activity could be considered part of a cuban contribution to global health security and may offer lessons for strengthening national and global rapid response capacities for disease emergence, as the deployments and training of the henry reeve brigade suggests. indeed, the global response to the - ebola epidemic was criticised as being 'hampered by a lack of trained and experienced personnel willing to deploy to the affected countries'. aside from important concerns regarding the rights bmj global health of medics deployed, cuba's medical brigades and the training they receive offer insights into how such a rapid response capacity might be achieved. moreover, the focus of cuba's medical internationalism in strengthening the provision of routine health services in resourceconstrained settings speaks to a broader vision of health security than disease containment and response alone-a focus of current debates concerning how global health security activities can be integrated in a more sustained way into broader health system strengthening and uhc aims. yet, this deployment of cuban teams has also raised concerns of taking jobs away from locally qualified physicians and healthcare workers, which raises further questions of sustainability within health systems as a cornerstone of uhc. discussions on cuban healthcare tend to focus on its government-run, integrated health system, rooted in a fundamental right to health as part of the socialist project; to provide a range of preventative and curative services free of charge to all. these services have produced worldleading health outcomes and demonstrate what is possible to accomplish in a resource-poor setting, allowing cuba to demonstrate a strong domestic health security position, although the veracity of some of these claims has been disputed. in particular, critiques have highlighted that the cuban image of a high-performing system appears to be almost exclusively based on infant mortality rates-an explicit point of focus of cuban government policy-at the cost of other health indicators, including maternal mortality, disability, disease exposure and life expectancy, and underinvestment in the social determinants of health more broadly. moreover, even this infant mortality rate has been questioned with regards to its accuracy, relative to the counterfactual and potential case-definitional differences to routine practice making cuba dramatically outperform its regional (and global) neighbours. focusing on infectious disease in particular, there are three key components to cuba's domestic health security: disease surveillance and control, cuba's biotechnology industry and universal healthcare. first, cuba has focused considerable efforts on reducing or eliminating disease threats from its territory. this has included decades of work reducing hiv/aids infection, including eradicating mother-to-child transmission of hiv, through prevention and destigmatisation campaigns, although this has come at a cost of human rights through the compulsory testing and indeed quarantining of those infected (interview, biosecurity expert). similarly, cuba eliminated malaria on the island in , and maintains this status, although through mandatory prophylaxis of those returning (or indeed arriving) in cuba from endemic regions. the country has also managed to eliminate diseases since , including measles, rubella, mumps, tetanus, meningitis b and c, and hepatitis b. (interview, ministerio de salud publica). when the threat of zika spread across the americas, cuba was quick to take proactive moves to stop the introduction of the disease within its borders. this included mass fumigation campaigns, the deployment of the military to clean civic spaces where mosquitoes may grow, and an appeal to citizens enforced by law, to support control efforts and ensure that private dwellings remained clear from mosquitoes and therefore, disease. such procedures are rooted in disease-specific action groups for health concerns; for example a dengue task force, empowered at multiple levels of governance from the municipality to the minsap and deployed in the case of a dengue outbreak with the exclusive task of bringing about the outbreak's end (interview, pan american health organization (paho)). this provides cuba with surge capacity to systematically respond to and manage health security concerns that occur within its borders. these groups work alongside the routine health service, and with civil defence units to respond to crisis events and mobilise quickly to minimise any potential threat to the population (interview, pan american health organization (paho)). more systematically, cuba has a distinct focus on rigorous point-of-entry controls. indeed, the main role of minsap's health surveillance unit is to prevent the introduction of infections to cuba (interview, ministerio de salud publica). when cuban nationals return to cuba from states that have endemic infectious diseases, they are subject to rigorous airport screening. this information is passed to their neighbourhood doctor for daily or weekly follow-up to ensure that individuals are not experiencing unusual symptoms and if they are, to facilitate rapid treatment, including if necessary, mandatory treatment and/or quarantine to avoid further disease transmission (interview, instituto de medicina tropical pedro kouri). the ability of the health system to facilitate such personalised follow-up, to ensure rapid treatment and to limit further infection is remarkable, and from a public health perspective, it far outperforms any health system in the global north, if not from a human rights perspective. these point-of-entry protocols are enforced for every flight and include airport scanners and in-airport medical professionals. if necessary, those arriving in cuba may be taken directly to a doctor and/or the tropical medicine institute, ipk (interview, instituto de medicina tropical pedro kouri). this quarantine and prophylaxis procedure at instituto de medicina tropical pedro kouri (ipk) includes all medics returning to cuba from ebola-infected or malaria-infected locations, who are subject to a mandatory days stay at ipk. second, cuba has a booming biotechnology industry, with significant investment made by the cuban state into research and drug development to ensure access to medicines should an outbreak emerge. as cuba is unable to purchase many global biomedical products, owing to the strict embargo placed on the country by usa, the bmj global health strides taken to ensure indigenous production of these medicines, treatments and future research represents demonstrable activity in maintaining cuba's health security to ensure a healthy and productive population. for example, this has included development of a vaccine for dengue fever, meningitis b, hepatitis b and many more besides. moreover, a biosecurity level laboratory (interview, ministerio de salud publica) and the development of other biomolecular diagnostic laboratories that can do diagnosis incountry mean that cuba does not have to send virus samples elsewhere (interview, ministerio de salud publica). third, cuba maintains almost uhc. uhc has been championed as a key mechanism to developing health systems resilient to disease outbreaks. cuba demonstrates how the mechanisms and processes for providing uhc to the population also provide the foundation for effective infectious disease control. cubans can seek medical advice through free and easily accessible consultations with health professionals through the consultorio (neighbourhood health clinic), established 'on every block' with a doctor and nurse in each communitywith approximately one consultorio per people. this has only been possible through significant government investment in healthcare as a priority since the revolution (although the motives for this are in part because the majority of doctors in cuba fled at that time (interview, pan american health organization (paho)). for more specialist care, patients are referred to a policlinico (polyclinic), particularly specialising in maternal and child health, chronic disease support and minor surgeries. the initial aim of this family centred programme was to decentralise hospital activities, to free up space in the system to manage the most serious of cases and to allow for surge capacity in the event of an emergency. yet the medics, and importantly nurses, who work in these consultorios and policlinicos who offer general medical provision also play a decisive role in epidemiology and disease prevention. in terms of epidemiological surveillance, the 'doctor on the corner' functions to record any epidemiological changes in the community. for example, dengue outbreaks, which occur with some frequency across cuba, are rapidly detected and within a matter of days integrated vector control activities will have begun due to the epidemiological reporting of the local consultorio. the close contact between the nuclear family and the doctor on every corner facilitates this rapid detection and response, ensuring that infections do not become major outbreaks and that infection control protocols are implemented (interview, ministerio de salud publica). this is in spite of no automated infrastructure and a paper-based surveillance system in a resource-poor setting. this infectious disease surveillance also pre-empts disease outbreaks through annual health checks on all members of the community (dispensarizacion). through this process, the consultorio preclassifies potential 'at risk' citizens based on social factors which may make them predisposed to infectious disease should it arise (interview, ministerio de salud publica; interview, pan american health organization (paho)). this preventative approach to disease control also relies on preventative care through increased vaccination coverage and health awareness among the population, reducing the chances of an outbreak taking hold in the country, the latter evidenced by the successful management of the hiv/ aids crisis on the island. thus, cuba demonstrates how the mechanisms and processes for providing uhc to the population also provide the foundation for effective infectious disease control, although this has been in a political context where the components of disease surveillance, biotechnology and universal healthcare form part of a broader narrative of regime preservation. indeed, if the goal of the cuban state is to preserve its borders and political narrative, then ensuring that its population has protection from infectious disease and access to routine healthcare functions also to reassure citizens in an effort to avoid internal sedition and lack of faith in the socialist project. nevertheless, while learnings from cuba must be considered within an instrumentalist paradigm and recognise that cuba's health security activities may not be as portable to different political and social environments, cuba's integration of community-based healthcare and disease surveillance and control activities does provide a pertinent example for broader global health security/ uhc debates as to what this might look like in practice, and how effective uhc can be for ensuring global health security. despite cuba's strong health security position, cuban health security activity is not framed as such, and this framing may well have an impact on cuban visibility within this global policy space. in turn, there are further impediments to cuban participation and recognition as a leader within the global health security architecture. for example, cuba claims to have met all the core capacity requirements for disease surveillance and control under the international health regulations (ihr) ( ), but has yet to agree to undergo a joint external evaluation (jee) to externally verify these capacities. although interviewees stated that plans were afoot for a jee in , we were unable to find evidence of this at the time of writing. this lack of clarification over the status of the jee is also mirrored in cuba's failure to report outbreak events to who, as required under the ihr ( ), including during the zika outbreak and rumoured cholera outbreaks across the island. where reports have been made, the case numbers reported have sometimes been manipulated so as not to reveal the full extent of the outbreak (interview, pan american health organization (paho)). thus, while cuba may demonstrate achievements in global health security, it also appears to be a reluctant player in the global health security regime. cuban health security activity, moreover, is not without its own challenges. as highlighted above, the ability for the state to mandate prophylaxis or quarantine for those potentially infected by a particular virus, not to mention pre-emptive activity on citizens deemed to represent risks to collective health security on the island, raises questions of civil liberties and human rights within the cuban health sector. much has been written about cuba's abuse of human rights and tight authoritarian control in other sectors, so this may not be of surprise from a broader cuban structural perspective. yet, within the health sector, there is no right to privacy in the physicianpatient relationship, no right to informed consent and no right to refuse treatment. these challenges point to an inherent tension within health security between the protection of civil liberties and public health, as encapsulated by the siracusa principles. the social control exercised by the cuban state thus raises questions of where the line between liberty and security lies and what rights governments have to restrict individual freedom in the name of public health-a debate that has also played out in other contexts, such as in the handling of patients with multidrug-resistant tuberculosis globally. a further challenge to cuba's health security is the level of underdevelopment that remains across much of the island. vast swathes of the island live in poverty, without routine access to water or sanitation services, with open sewers or water that is unable to drain because of poor civic planning (interview, pan american health organization (paho)). this can have a direct influence on susceptibility to vectorborne or waterborne disease. failure to maintain sewage systems in a civic infrastructure struggling to financially support itself has led to an increase in diarrhoeal disease and cholera. this lack of investment in the socioeconomic determinants of health, potentially as a consequence of the decisive focus on infant mortality within the health sector, poses a contradiction to so much of the success that cuba can show in terms of an exemplary health security capacity in such a resource-poor setting. it also demonstrates the inequalities across the system; while the consultorio model and thus 'health security' may work in urban areas, this may not be replicated across the system in poorer zones (interview, pan american health organization (paho)). thus, socioeconomic development and indeed, resources remain a key limitation of health security in cuba. lack of government funds means that in the event of a major outbreak there may be limitations on equipment, deployment activities elsewhere, and research and development achievements. these resource constraints are exacerbated by the us embargo, which has been almost continuously in place since . this has wide-ranging effects across areas of domestic policy, and despite having little impact on life expectancy, we propose that the embargo does have a potential impact on the health security strengths of the system. for example, the embargo on us goods means that pharmaceutical ingredients or products produced in usa or with a patent held by a us company are not available in cuba. this means that cuban access to newer international drugs is limited and may directly impact on the health security of the nation if a newly emerging pathogen appears and a drug is developed that cubans are not able to access (interview, ministerio de salud publica). this also extends to medical equipment. there have been efforts by cuban medics to circumvent this medical embargo, through sourcing medication from third party states, but this has been met with indignation and legal challenge by the usa. while it is impossible to imagine a replication of the cuban health system in other resource-poor settings owing to the uniqueness of the political situation, this is not to say that meaningful lessons cannot be ported. in particular, cuba demonstrates how a health system that is prevention-oriented and community-based contributes to reducing infectious disease threats-a key point of focus in contemporary global health security debates. here cuba provides a much needed example of how disease surveillance and control efforts can be integrated with community-based primary healthcare to provide for health security in low-income settings. cuba's medical internationalism, moreover, demonstrates the effectiveness of frequently offering national doctors for international disease control efforts, allowing for a welltrained and readily deployable medical corps to respond to disease both within cuba and abroad. the training provided to the henry reeve brigade in responding to the ebola outbreak is particularly illustrative of how national and global surge capacity to respond rapidly to health crises might be achieved. the focus on strengthening routine healthcare as well as health crisis response in cuba's medical internationalism, moreover, opens up space to reflect on how global health security activities might be integrated into longer-term health interventions. despite these activities, however, cuba remains largely at the margins of global health security policy and debate, with implications for cuba's engagement with the global health security regime, as encapsulated by the ihr ( ), and for cuba's visibility in global health security policy and practice. indeed, the us embargo, cuba's development and resource challenges, and the tight social controls exercised by the state in managing disease threats in its territory also speak to broader global health security issues. these concern global access to essential medicines and commodities, the development of sectors beyond health alone in reducing vulnerability to disease, and the trade-off between civil liberties and public health in disease control efforts. the cuban case thus offers opportunity for more in-depth reflection as to the strengths and weaknesses of contemporary health security practices, although with the caveat that lesson learning should be applied cautiously in this context given bmj global health the tensions within the cuban political system in relation to civil and political freedoms, the critiques concerning cuba's instrumentalist promotion of its health system and the trade-offs which had been decisively made for the prioritisation of disease control and infant mortality. correction notice this article has been corrected since it published online to reflect the correct author names in reference . twitter clare wenham @clarewenham microbial threats to health: emergence, detection. and response toward a common secure future: four global commissions in the wake of ebola sustainable development goals will ebola change the game? ten essential 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restrictive options for tuberculosis control an evaluation of four decades of cuban healthcare effect of the u.s. embargo and economic decline on health in cuba acknowledgements the authors thank lse latin american and caribbean centre including helen yaffe, gareth jones and alvaro mendez for their discussions during the research phase of this study. contributors cw and skk conceived, designed and undertook the research. they both wrote the final paper. competing interests none declared.patient and public involvement patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.patient consent for publication not required.ethics approval ethical approval was obtained from lse ethics committee ( ).provenance and peer review not commissioned; externally peer reviewed. key: cord- -obeinwyq authors: horton, richard title: canada : what should global health expect? date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: obeinwyq nan for south africa in , it is the world cup. for canada, it is the g -on jan , , canada takes over the g presidency. as the predicaments facing the world's leading economies grow ever more complex, canada's global leadership has never been more keenly needed. over the next months, canada has an opportunity to make a decisive impact on global health. canada could learn a great deal from japan's example. japan occupied the g presidency in . the country's foreign policy team, together with national health leaders, prepared early. in , japan's foreign minister signalled his commitment to international health through human security. the government proceeded to create an academic collaboration to propose action on health systems. that proposal fed directly into the g meeting itself and led to a post-g process that identifi ed key policy areas for priority action: the health workforce, fi nancing, and information. an attempt was made at a collaborative handover with italy in , but internal italian political distractions-the personal life of silvio burlusconi-made something of a dead year in g history. it is now time for canada to restart the g engine. prime minister stephen harper has already signalled four priorities: the global economy, climate change, development, and democratic governance. but canada's health community has so far been silent publicly on what canada's priorities should be. canada has many natural advantages to shape its international policyworld-class universities with global ambitions, a history of international policy infl uence (eg, the lalonde report, which redrew the boundaries of health), frontrank scientists and intellectuals who have redefi ned what is possible in health, - and increasing overseas development assistance. the most prominent anomaly canada has to address is the failure of the international institutional and donor architecture to address in any comprehensive and co herent way the catastrophic failure in progress towards the millennium development goals (mdgs). integrating funding for maternal, newborn, and child health into the global fund for aids, tuberculosis and malaria and the us president's emergency plan for aids relief is urgently needed if mdg targets are to be met in . but beyond rebalancing existing programmes, canada's unique experience as a nation could lead it to make important contributions in fi ve further dimensions of global health. first, health systems. canada's health service benefi ts from relatively low health disparities, high levels of public solidarity, and a strong commitment to equity. universal coverage is now top of the global health agenda. , canada must deepen and broaden g commitments to health-systems strengthening. second, climate change. this issue is already a canadian priority. but the health aspects of global warming are largely invisible. the lancet-ucl commission on the health eff ects of climate change argued that global warming is the biggest threat to health in the st century. this view has been backed by doctors' leaders. , health advocates in canada need to press this point on their politicians as additional evidence for concerted action. third, peace through health. canada has been the leading nation bar none to develop the concept of peace dividends through policies on health. [ ] [ ] [ ] this idea has catalysed governments to embrace health as a vital force in foreign policy. as suff ering escalates in zones of confl ict such as afghanistan, embedding health in political thinking is critical to promote peace and reconstruction. fourth, indigenous health. some canadian writers, such as john ralston saul, argue that canada is more aboriginal than european. in a fair country, saul suggests that canada's inclusiveness and egalitarianism stem from these indigenous roots and that if canada is to free the full creative energy of future generations, it must embrace its indigenous past. with million indigenous people living in disrupted, exploited, and marginalised circumstances today, canada's voice-as a country with an important indigenous population-has the potential to command respect and infl uence. , the recent commission on social determinants of health emphasised the importance of inclusion and empowerment for indigenous peoples in governmental policy making. and fi nally, global evidence and ethics. as the birthplace of evidence-based medicine, canada's health community should have a strong voice about the way health metrics are used to shape global health policies. to be fair, canada's health community has called for increased canadian awareness, involvement, and funding in international health. [ ] [ ] [ ] these calls need to be channelled into a more coherent response. perhaps it is time for a change-a canadian health action network for global equity. the creation of such a coalition of canadian academic and institutional health interests could contribute signifi cantly to canada's g agenda. a change could also off er a mechanism for sustained follow-up and continuitybetween diff erent political parties and as the g chair rotates between nations. canada's evolution as a nation through the lens of health reveals a deepening commitment to global aff airs. in the th century canadian doctors and public health offi cials reached out beyond canada's borders to attract health workers to help build a national health system. the country's planners broadened the reach of canada's health system westwards. health leaders identifi ed the crucial importance of reliable information to shape the progress of canada's development. severe acute respiratory syndrome illustrated the powerful fact that no nation can be immune from the global forces of disease. and canada's political leadership now recognises that the institutions that govern the world today need to become more democratic and representative. a long-forgotten but exemplary canadian public health leader, charles hodgetts, once wrote about "health as a foundation of government". this is as true today in a global context as it was in canada a century ago. it is up to the canadian health community to seize the opportunity that now off ers. the lancet, london nw by, uk a version of this comment was presented at the university of british columbia, vancouver, bc, canada, on sept , . i owe thanks to many canadian colleagues who off ered views on the arguments presented here. global health and japan's foreign policy global action on health systems: a proposal for the toyako g summit human security approach for global health g and strengthening of health systems: follow-up to the toyako summit italian g summit: a critical juncture for global health g summit : what approach will italy take to health? the case for expanding access to highly active antiretroviral therapy to curb the growth of the hiv epidemic globalisation and health: the need for a global vision avoidable global cancer deaths and total deaths from smoking what will it take to stop maternal deaths? all for universal health coverage who maximising positive synergies collaborative group. an assessment of interactions between global health initiatives and country health systems lancet-ucl institute for global health commission: managing the health eff ects of climate change health and climate change politicians must heed health eff ects of climate change health and peace: time for a new discipline the mcmaster-lancet health and peace conferences peace through health: key concepts oslo ministerial declaration-global health: a pressing foreign policy issue of our time suff ering, and mental health in afghanistan: a school-based survey a fair country indigenous health : determinants and disease patterns indigenous health : the underlying causes of the health gap commission on social determinants of health. closing the gap in a generation the rich-poor gap in global health research: challenges for canada coordinating canada's research response to global health challenges critical public health ethics and canada's role in global health department of health for canada key: cord- -ewf xhqi authors: kerry, vanessa b.; sayeed, sadath title: leveraging opportunities for critical care in resource-limited settings date: - - journal: global heart doi: . /j.gheart. . . sha: doc_id: cord_uid: ewf xhqi nan vanessa b. kerry* ,y,z,x , sadath sayeed z,x,k boston, ma, usa critical or intensive care is, in its simplest rendition, the provision of medical care for the severely ill patient. in its more advanced forms, critical care can provide needed support to temporarily do the work of almost any vital end organ, such as dialysis to mimic the actions of the native renal system, or ventilation and oxygenation to mimic the native actions of the respiratory system. in advanced health systems, a critical care unit is often relied on to provide escalated care for patients at risk of imminent death in order to prevent an untimely demise. critical care as a clinical discipline in resource-rich settings is associated with highresource (financial, human, technological) intensity. for this reason, among others, critical care has received far less investment in resource-poor countries suffering from huge epidemics of communicable diseases such as human immunodeficiency virus (hiv)/acquired immunodeficiency syndrome, tuberculosis, and malaria. however, with improved strategies and increased access to medications to treat the major infectious disease killers in many if not most countries, the need to turn attention to address the critical care gap between rich and poor is clearer than before. although numerous challenges to scaling up high-quality intensive care services present themselves, even more opportunities to creatively innovate in this field exist that hold promise to move us closer to equity in global health care. at the individual patient level, the need for critical care is often unpredictable and can occur unexpectedly with any number of initially discrete disease processes that lead to acute end organ compromise or failure. because death is often attributed to antecedent pathologies, and because data on the actual need for critical care services in resource-limited settings is extremely difficult to collect, the exact contribution of critical care to the global morbidity and mortality is not well characterized. a lancet study in aimed to provide epidemiological estimates of the global burden of critical care morbidity and mortality [ ] . the investigators argued that existing data on critical illness prevalence to date was incomplete because the data failed to provide accurate population-based incidence of critical illness and overwhelmingly did not include data from resource-limited settings. to attempt to provide a more comprehensive picture of the global burden of critical illness using "prototypical" illnesses of sepsis, acute lung injury, and mechanical ventilation, the investigators drew incidence and prevalence rates from observational population-based studies in several countries [ e ] and applied them to data on population and deaths from the global burden of disease project by world bank regions [ ] . the results demonstrated significant burden across all regions, but especially in east and south asia and sub-saharan africa ( table ) [ ] . prevention and/or early treatment of common infectious diseases remains the mainstay strategy to reduce the burden of mortality in resource-limited countries; many recent efforts have focused on piloting or scaling innovative "delivery" strategies to large at-risk populations. however, % of all deaths from infectious diseases including from hiv, diarrhea, meningitis, and pneumonia; % of all deaths from trauma; and % of deaths from cardiovascular causes occur in resource-limited countries because cases present or advance beyond stages at which early treatment is effective [ ] . a south african survey of admissions to a secondary-level hospital in south africa found that % of admitted patients were sufficiently ill to merit intensive care unit (icu)-level care [ , ] . it is plausible that large proportions of hospital deaths could be prevented with access to adequate but not necessarily highly costly critical care services. current quality of critical care is often informal and absent [ ] , and, in many cases, basic triage systems do not exist [ e ]. a decision to invest in critical care services in resourcelimited settings is often simplistically criticized as an ineffective use of scarce resources. simultaneously, agendasetting donors often insist that investments exclusively follow a macroscopic public health model where community health and primary care are seen as the only sustainable means to reduce disease burden. putting aside larger social justice questions about the geo-political-socialeconomic-historical circumstances that have led some "northern" countries to have significantly more power and resources than their "southern" counterparts, these stereotypical responses miss the point that caring for critically ill patients need not be prohibitively expensive. they also miss the target in failing to acknowledge that some disease conditions are not preventable or present beyond the point of simple pill taking. as riviello et al. [ ] note in their review, [care for critically ill patients] may include oxygen administration or frequent nurse monitoring. although these interventions may not be considered critical care in resource-rich settings, they are nonetheless important aspects of caring for critically ill patients and not universally available. further, critical care could strengthen hospitals' overall ability to provide better care, which is essential to both improving outcomes [ , e ] and to increasing public opinion to seek care in facilities. currently, populations often perceive hospitals in resource-limited settings as a place where one goes to die. the debate and scale-up of critical care should thus center not on whether it is worth the investment writ large, but instead on determining those aspects of critical care that can be easily implemented in order to build a foundation to grow more advanced capabilities over time. oxygen, a lifesaving therapy, for example, can cost little [ ] , and studies have shown that the introduction of oxygen and pulse oximetry can reduce fatalities from pneumonia [ ] . adequate patient-to-nursing ratios are an important prerequisite to close monitoring and timely intervention. these inexpensive interventions do not depend on advanced technology. measured against the world health organization definition of cost-effectiveness [ ] , a number of studies have helped demonstrate that critical care interventions are meritable and cost-effective [ , e ] . there is an increasing amount of literature describing critical care in resource-limited settings [ , , ] , the demographics in particular icus [ , e ] , the challenges to scaling up icu care [ , ] , and recommendations [ , , ] . despite the challenges, there are many readily available opportunities to change the quantity, quality, and distribution of critical care in many resource-limited settings. these opportunities can be broadly categorized as effective triage; equipment and resources; training and human resources; task shifting and protocolized care; and affordable technology and research and information dissemination. effective triage systems can help improve patient care and mortality for admissions from ambulance and emergency and outpatient units [ , ] and for management of patients on the inpatient ward [ ] . yet, many sites lack effective triage systems for either [ e ] . this can result in delays in treatment, which can be the difference between life and death. appropriate triage systems can be instituted to be nurse-or medical-traineeeled to optimize available human resources. further, certain emergency treatments can be administered before a specific diagnosis is made [ ] . finally, movement of critically ill patients to a dedicated unit can achieve goals. first, it can ensure more monitored care for a critically ill patient. second, clustering of critically ill patients together can help pool available resources and ensure their more efficient use [ , ] . the most severely ill patients need close monitoring to assess cardiopulmonary function, including heart rate and rhythm, blood pressure, and oxygen saturation. this can be achieved by continuous electronic monitoring with purchased or donated equipment. frequent vital signs supported by spot echocardiograms can help yield important information in the absence of electronic monitoring. laboratory monitoring is also essential with special attention to electrolytes; hemoglobin; glucose; blood urea nitrogen; creatinine; and, ideally, arterial blood gases, coagulation, and lactate. even though central labs are often rare or poorly most resource-limited settings are challenged by severe staffing needs. the world health organization has identified more than countries with critical health professional shortages [ ] . these shortages are perpetuated by loss of trained personnel to more resource-rich settings [ ] , as well as poor training opportunities [ e ]. trained intensivists are rare in resource-limited settings where critical care is often managed by internal medicine, anesthesia, or general surgeryetrained physicians [ ] . in a recent survey of hospitals on icu resources, included in this issue of global heart, of the responding hospitals cited trained staff as a central, needed input for better iculevel care at their facility [ ] . appropriately trained physicians, nurses, and support staff are essential to scaling up even the most modest critical-care services. there are growing partnerships across institutions in resource-rich countries that partner with institutions in resourcelimited countries, which can help expand training [ ] . ongoing professional development opportunities for local staff can occur through dedicated mentorship, didactics and focused courses, and teaching on new modalities. training needs to encompass both clinical education and increased research and knowledge generation. it should prioritize competencies over just knowledge. yet, many training programs are currently dominated by lectures and didactics that fail to offer bedside clinical management of patients [ e ]. increased faculty and staff will be needed to provide the supervision and sustained mentorship needed. several training programs, academic partnerships, and consortia are adopting this model both broadly and in other clinical specialties [ , e ] . task shifting and empowering staff such as nurses to initiate certain treatments before diagnosis or physician evaluation can have an impact. though both doctors and nurses are in short supply, the vast majority of health care is provided by nonphysicians in resource-limited settings. the increase in protocols [ ] , checklists [ ] , and bundled care [ e ] help facilitate both direct care and task shifting by creating processes that rely less on advanced knowledge than on adherence. they will reduce variability of care across providers and institutions and can help promote a culture of safety and accountability. protocols have been implemented for sepsis [ ] , weaning of ventilation [ e ], glucose control [ e ], and sedation [ , ] . recently, checklists have been implemented effectively to help improve mortality and reduce complications in surgery in settings of both high and low resources. this is promising for similar interventions in critical care because both fields are complex, technical, and multidisciplinary [ , , ] . care will be needed to adapt these guidelines appropriately to resource-limited settings. for example, blood gases or central venous oxygen saturations may not readily be available. however, there are opportunities. sepsis guidelines have been adapted to help provide definition and recommendations on management including fluid resuscitation, timely antibiotics, airway protection, and source control [ , ] . affordable technology is an underdeveloped opportunity to transform critical care as well as global health broadly [ ] . technology advancements can include pharmaceuticals, vaccines, diagnostics, devices, and communications. examples include a negative pressure wound therapy device that decreases the cost and energy reliance of traditional wound pumps, increasing its applicability in resourcelimited settings. the new device costs approximately $ to manufacture [ ] . another example is an add-on device to ventilation equipment to monitor and record resuscitation performance, to provide real-time feedback on technique, and to improve training and care [ ] . the device measures the rate and pressure of air entering an infant's lungs and can signal correct mask seal, need to augment or slow rate of breath delivery, and other parameters. such technologies designed in resource-limited contexts can lead to reverse innovation to help improve care and reduce costs in more developed healthcare contexts. further, adaptation and leveraging of existing technology can have an impact. smart phones have been used with enough fidelity to reproduce a detailed neurological exam [ ] . low-cost mobile devices have been adapted in resource-limited settings to provide diagnostic testing for hiv and then to synchronize results in real time with electronic medical health records to expand both care and epidemiological data collection [ ] . research and its dissemination are essential to broadening the understanding of specific disease pathophysiology and management. knowledge gaps stem from differences in acute disease burden depending on geography, such as with ebola, severe acute respiratory syndrome, or middle east respiratory syndrome, as well as from management in resource-limited areas where diagnostics and treatment modalities may not be readily available or patients present in the community and not at more centralized health facilities. important areas for mutual collaboration and scale-up include developing research priorities, technical capacity building, mentorship, and dissemination where local investigators should take the lead with support from partners [ ] . research should center on needs assessment, prognostic scoring, implementation and outcomes of appropriate management, costeffectiveness, and affordable technology solutions [ , ] . perhaps the most compelling rationale for building critical care capacity in resource-limited settings is its power to save younger lives. whereas much of critical care in resource-rich countries is in older populations who spend longer periods in icus supported by complex technology, in resource-limited settings, the majority of critically ill patients are children and young adults [ , ] . in this population, short-term interventions can be transformative gopinion j global heart, vol. , no. , and have a significant impact on not only the individual, but also the community. for example, saving a young woman's life from peripleural sepsis will ensure her children are more likely to live to the age of years and less likely to be socially or economically disadvantaged over their lifetime [ ] . avoiding preventable death will not only reduce mortality and disease burden, but it will help improve life expectancy, decrease birth rates, increase household productivity, and even have an impact on gross domestic product [ ] . investments in critical care need not be technology or cost intensive, but they should be appropriate and effective. such investments, though, will have dividends across many clinical specialties as well as have an impact on the health outcomes of a population. critical care and the global burden of critical illness in adults for the arf study group. incidence and mortality after acute respiratory failure and acute respiratory distress syndrome in sweden, denmark, and iceland the epidemiology of sepsis in the united states from through epidemiology of severe sepsis in the united states: analysis of incidence, outcome, and associated costs of care for the australian and new zealand intensive care society clinical trials group. incidence 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medical education in sub-saharan africa: seeking the evidence for effective collaborations responding to the hiv pandemic: the power of an academic medical partnership global health service partnership: building health professional leadership human resource for health e rwanda: program overview using protocols to improve the outcomes of critically ill patients with infection: focus on ventilator-associated pneumonia and severe sepsis for the safe surgery saves lives study group. a surgical safety checklist to reduce morbidity and mortality in a global population for the early goal-directed therapy collaborative group. early goal-directed therapy in the treatment of severe sepsis and septic shock duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock sustaining reductions in catheter related bloodstream 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failure in non-diabetic cardiac surgical patients effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation implementation of evidence-based innovative bundle checklist for reduction of surgical site infection effect of using a safety checklist on patient complications after surgery surviving sepsis in low-income and middle-income countries: new directions for care and research technologies for global health mms-news-releases/boston-university-medical-student-mass% general-hospital-team-of-residents-are-winners-of-information-technology-awards-from-massachusetts-medical-society/#.u ifjhbwlz . accessed mobile device for disease diagnosis and data tracking in resource-limited settings the impact of the president's emergency plan for aids relief (pepfar) beyond hiv and why it remains essential intensive care in low-income countries-a critical need for the study group for the global investment framework for women's and children's health. advancing social and economic development by investing in women's and children's health: a new global investment framework macroeconomics and health: investing in health for economic development the authors report no relationships that could be construed as a conflict of interest. key: cord- -tufbqesg authors: amon, joseph j title: human rights protections are needed alongside ppe for health-care workers responding to covid- date: - - journal: lancet glob health doi: . /s - x( ) - sha: doc_id: cord_uid: tufbqesg nan health-care workers have experienced violence, harassment, and discrimination in their communities, and have been forced to move from their homes or physically attacked. qian liu and colleagues (june, ) examined health workers' experience responding to covid- in hubei province, china. the authors highlight three key themes, related to duty and sacrifice, the challenges of working in a crisis setting, and resilience amid challenges. absent from this picture were two themes reported elsewhere-the chinese government failing to protect health-care workers or censoring and detaining them for speaking out. in february, , a nurse from wuhan central hospital posted a devastating picture of neglect of health workers and fear of government reprisal on social media, writing that the actual situation was "not as good as reported. the situation is more serious…nobody dare[s] to speak the truth…now nobody has time to care for us. supplies are not distributed. we can only report good news not bad news…there is certainly gratitude, but more is [sic] anger." in china, speaking critically of the government can bring about harsh punishment. since january, , numerous people have been detained for their online speech, and often accused of rumour-mongering. dr li wenliang, who first raised the alarm about covid- , was forced to sign a confession in which he was accused of making false statements that disturbed the public order. the chinese government is currently detaining three beijing-based activists who operated a webpage to collect censored covid- stories, and two citizen journalists after reporting on the pandemic. the message to health-care workers is clear-resilience amid challenges does not include demanding adequate personal protective equipment (ppe) or speaking out about conditions. censorship and attacks on healthcare workers responding to covid- are not limited to china. in the indian state of west bengal, a criminal complaint was registered against a doctor who spoke out about the lack of ppe for frontline health workers. from march , to april , , the nongovernmental organisation insecurity insight identified events in countries, ranging from protests, to blocking health-care facilities, to threats and attacks on health workers in the context of covid- . the nightly demonstrations of appreciation for health-care workers taking place worldwide have been heartening, and there is no doubt that workers are showing a sense of duty, forbearance, and resilience. but these workers need more than ppe and appreciation. they also need their human rights to be respected, including the right to speak out and to be protected from attack, government intimidation, harassment, and arrest. international council of nurses. icn calls for data on healthcare worker infection rates chinese red cross foundation. public announcement characteristics of health care personnel with covid- -united states afraid to be a nurse": health workers under attack. the new york times the experiences of health-care providers during the covid- crisis in china: a qualitative study i don't want to be a deserter nor a hero"-the real situation of wuhan medical care citizen journalists": arbitrary detentions, "disappearances," for sharing coronavirus information covid- : restricting health workers' free speech has a chilling effect switzerland: insecurity insight key: cord- -xzgfwu a authors: kamin-friedman, shelly title: would it be legally justified to impose vaccination in israel? examining the issue in light of the detection of polio in israeli sewage date: - - journal: isr j health policy res doi: . /s - - -z sha: doc_id: cord_uid: xzgfwu a background: the detection of wild poliovirus in israeli sewage in may led the health authorities to decide that children who had been vaccinated with ipv would also be vaccinated with opv. the decision sought to protect vulnerable israeli individuals who were either not vaccinated with ipv or who suffered from an immune deficiency, to preserve israel’s status as a polio-free country, to prevent the virus’ “exportation” into vulnerable polio-free countries, and to participate in the global efforts toward the eradication of polio. after a massive public persuasion campaign, % of the children born after were vaccinated as well as % of the children residing in central israel. a state comptroller report stated that the ministry of health should draw conclusions from the low compliance rates in certain israeli regions. goals: the article seeks to examine the legal legitimacy of mandatory vaccination in the service of eradicating a contagious disease (as opposed to preventing a pandemic outbreak), which was one of the objectives in the polio case. it more specifically relates to current israeli law as well as to a hypothetical new public health law which would authorize health officials to oblige vaccination and enforce this through the use of criminal sanctions. method: qualitative content analysis through the interpretation of court judgements, laws, legislative protocols, health ministry guidelines and documented discussions of the advisory committee on infectious diseases and immunization. main findings and conclusion: a mandatory vaccination backed by criminal sanctions in the service of the eradication of contagious diseases would probably be perceived as infringing on the constitutional right to autonomy to a greater extent than necessary according to israeli law and case law precedents. there may be some added value inherent in a new public health law which would authorize health officials to oblige vaccination where nonrestrictive measures have been ineffective. however, the law should also specify a variety of sanctions to accompany the enforcement of mandatory vaccinations which would be formulated from least to most restrictive according to the “intervention ladder” concept. the law should also describe the circumstances which would justify the implementation of each and every sanction as well as the procedural safeguards designed for established decisions and fairness toward the individual(s) whose rights are infringed by the application of these sanctions. polio is a severe disease which may cause paralysis. two types of vaccines have been used against it since the s and s: ipvinactivated polio vaccine, which induces humoral immunity but does not prevent intestinal infection, and opvan attenuated oral polio vaccine which induces a local and mucosal immune response in the intestinal mucous membrane and is later excreted. it thus not only protects the individual but can also be spread to others in close contact with the vaccinated individual and induce the "incidental" immunization of people who have not been directly vaccinated. a recipient of an opv or an unimmunized close contact may rarely develop paralytic polio as a result of the vaccine. however, giving an opv to someone already immunized with an ipv is very safe [ ] . israel started vaccinating children against polio in . the immunization schedule changed according to developments in both opv and ipv vaccines and according to epidemiological considerations. after the outbreak of the disease, israeli children were routinely vaccinated with a combination of opv and ipv. the vaccine did indeed significantly reduce polio morbidity. a total of cases of vappvaccine associated paralytic poliomyelitis have been reported between the beginning of monitoring in and , when the last recorded case of vapp was diagnosed. of these were diagnosed in vaccine recipients and in people who were in contact with vaccines [ ] . since there have been no cases of polio in israel for years, and since the who recognized israel as a poliofree country, israeli children have, in accordance with who guidelines [ ] , been vaccinated with ipv alone since . in may , and due to the consistent detection of wild poliovirus in israeli sewage in several sample and growing concentrations, israeli health authorities made efforts to reach unvaccinated children and vaccinate them with ipv. however, these efforts did not stop the environmental spread of the virus. in june , a who delegation to israel, the cdc and the israeli polio committee advised that children who had been vaccinated with ipv since should also be vaccinated with opv. on august , the parents of children in southern israel who were born after were asked to vaccinate them with opv. the recommendation was later extended to cover all israeli parents of children born after since the wild poliovirus had been detected in other areas too [ ] . the objectives of adding opv to israeli children already vaccinated with ipv were the protection of vulnerable israeli individuals who were not vaccinated with ipv or who suffered from immune deficiency, the preservation of israel's status as a polio-free country, the prevention of the virus' "exportation" to vulnerable polio-free countries, and participation in the global efforts toward the eradication of polio. it should, however, be noted that the ipv had been routinely administrated to more than % of israeli children by the time the wild poliovirus was detected in israeli sewage. as ipv decreases both the risk of infection and infectiousness [ ] , its high coverage prevented a polio outbreak in israel [ ] [ ] [ ] . in order to promote compliance with opv, and proceeding from an understanding that the main policy communication challenge would lie in persuading parents to vaccinate their children for the sake of others, the ministry of health initiated a campaign which called on parents to vaccinate their children in order to protect unvaccinated family members using the slogan "two drops and the family is protected" to this end. the ministry of health chose to provide the public with information about the vaccine without sanctioning parents who decided not to vaccinate their children. in choosing this policy, the ministry of health sought to preserve the parents' right for autonomy. a petition against the vaccination campaign later was submitted to the supreme court by an anti-vaccination group. the petitioners claimed that the ministry of health was not providing sufficient information about the nature and the dangers of opv including the fact that the vaccine does not benefit the children who receive it. the court heard the case on august , and recommended that the petitioners withdraw their petition, which they did [ ] . the global polio eradication initiative's independent monitoring board noted that "israel faced a real policy and communications challenge, compounded by the fact that there is a sizable body of anti-vaccination sentiment within the population" [ ]. following a public persuasion campaign, % of the children born after were vaccinated with opv as well as % of children born after and residing in central of israel [ ] . a state comptroller report stated that the ministry of health should draw conclusions from the low compliance rates in certain israeli regions [ ] . achieving optimal vaccination uptake rates troubles health policy makers in both israel and in other countries. the detection of wild polio in israeli sewage demonstrates the necessity for interventions aimed at promoting vaccination compliance in cases where persuasion alone has not given rise to an optimal uptake rate. as was mentioned above, the promotion of compliance with opv had several objectives. however, the following discussion will focus on the legal legitimacy of mandatory vaccination (enforced by criminal sanctions) in the service of the global eradication of polio. this examination is especially important in light of the current public health policy makers' ambition to eradicate contagious diseases as opposed to past interventions which sought to prevent epidemics. the legal issues raised by the analysis would be relevant to interventions in other cases which seek to attain complete eradication. from a wider perspective, the discussion would be relevant to public health interventions in additional fields, as many of them contain an inherent tension between the ambition of promoting public health and the legal obligation to protect individual rights: "achieving a just balance between the powers and duties of the state to defend and advance the public health and constitutionally protected rights poses an enduring problem for public health law" [ ] . a qualitative content analysis research was conducted on relevant court decisions, laws, legislative proceedings, and legislative protocols (all issued or produced between and ). a further analysis was carried out on health ministry guidelines and on documented discussions of the advisory committee on infectious diseases and immunization. the study was initiated by analyzing the aforementioned data which was then linked to the relevant theoretical literature such as to attain a cohesive entity. credibility was established through persistent observation. the justification for government intervention in the service of promoting vaccination compliance and the legal means for such interventions according to l.o. gostin the public in a democratic society authorizes the government to act for the common welfare. the government thus possesses the sole authority to empower, regulate, or carry out activities designed for the protection or promotion of the general health, safety, and welfare of the population [ ] . the iom emphasizes that "there are solid legal, theoretical, and practical grounds for government in its various forms to assume primary responsibility for the public's health" [ , ] . the israel supreme court (justice barak-erez) addressed the issue in the adalah decision which will be described in detail below [ ] , and held that the market failure which derives from individual nonvaccination decisions grounded in the notion of "herd immunity" justifies government intervention. moreover, the israeli basic law: human dignity and liberty ( § ) provides that the government has an obligation to protect the life, body, and dignity of every individual. although the right for health has not been recognized as a basic right, an intervention meant for the eradication of a contagious disease may be considered essential to the protection of human dignity as well as human life and the human body [ , ] . in attempting to promote vaccination compliance, public health authorities can employ such intervention strategies as client reminders or recalls, the enhancement of access to vaccination services, and the provision of information to target populations or vaccination providers [ , ] . however, sanctions against individuals who refuse vaccination require specific legislative authorization. all us states have laws that require vaccination for school admissions. exemptions vary from state to state, although all school immunization laws grant exemptions to children for medical reasons, and almost all states grant religious exemptions for people who have religious beliefs that prohibit immunizations. states also currently allow philosophical exemptions to those who object to immunization on account of personal, moral or other beliefs [ , ] ; in canada, three provinces require proof of immunization for school admissions: ontario, new brunswick and manitoba. exceptions are permitted on medical or religious grounds and for reasons of conscience. australia's new tax system (family assistance) act states that family tax benefits, child care rebates and child care benefits can only be paid for children who meet immunization requirements. a person may have a medical exemption from vaccination if they are undergoing treatment that compromises their immune system. religious or conscientious objection is not an exemption category [ ] [ ] [ ] . israel's advisory committee on infectious diseases and immunization (which advises the israeli ministry of health) discussed the possibility of requiring children's vaccination prior to their admission to the education system in . the committee advised that less intrusive measures should be adopted in order to increase vaccination compliance, and also stated that a mandatory vaccination requirement would not be effective due to enforcement difficulties and the expected number of exemptions that would be granted to parents opposing vaccination. it was therefore decided that a vaccination reminder would be given to all parents who registered their child in an educational institution but that no measures aimed at compelling them to do so would be taken. the possibility of using preschool registration to promote vaccination compliance was re-discussed by the advisory committee on infectious diseases and immunization in january . among other things, the committee discussed the suggestion of requiring a confirmation from a mother and child clinic that the child entering preschool had been vaccinated in the manner recommended by the ministry of health. it also discussed a suggestion requiring parents who oppose vaccination to sign an objection form. both suggestions were rejected by the committee for several reasons: first, israeli law does not permit the requirement of vaccinations as a precondition for education; second, the committee believed municipalities would encounter difficulties in implementing the requirement; and third, there was insufficient evidence to indicate that the implementation of such policies would be efficient and that it would promote vaccination compliance [ ] . the committee agreed that the central vaccination registry (which did not exist at the time) would be used to remind parents to vaccinate their children and to promote vaccination compliance. furthermore, the israeli social security law of was amended in such as to require vaccination in accordance with ministry of health recommendations in order to receive an additional child allowance. ministry of finance representatives supported the financial sanction and emphasized that it had been proven its effectiveness in other countries. ministry of health representatives added that israel's unvaccinated population is the reason for disease outbreaks, and that providing parents with a vaccination incentive might promote compliance [ ] . a petition against the amendment was later submitted to the israeli supreme court in adalah legal center v. the israeli ministry of social affairs and social services ( ). the petitioners claimed that depriving families with an unvaccinated child of the additional child allowance is a violation of constitutional rights. in a decision delivered on . . all three judges agreed that the constitutional right to dignity and the constitutional right to autonomy were not being violated in this case. justice arbel held that the question of whether the right to autonomy was violated should be answered with respect to the nature of the choice being deprived from the individual and the extent of the coercion applied to this end. the law's amendment deprives the families of a small financial benefit and does not impose a criminal sanction on parents who refuse to vaccinate their children [ ] . justice barak-erez clarified that a financial sanction (unlike a criminal sanction) allows parents the freedom of choosing their actions [ ] . as for the constitutional right to equality, justice hayut held that legislators are authorized to relate differently to parents who vaccinate their children as opposed to those who refuse to do so [ ] . justice arbel, on the other hand, was of the opinion that the above distinction is immaterial to the child allowance's initial purposethe assurance of minimal financial conditions for survival, meaning that the right to equality is indeed being violated in this case. nonetheless, justice arbel also concluded that this constitutional right violation complies with the stipulations laid down in the limitation clause ( § of the basic law: human dignity and liberty) specified hereunder [ ] . justice barak-erez did not positively hold that depriving the additional child allowance from families with an unvaccinated child represents a violation of the right to equality, but agreed with justice arbel that the law's amendment complied with the stipulations provided in the limitation clause: the amendment has a proper purpose (to protect unvaccinated children and promote public health); there is high probability that a financial sanction would be effective and promote vaccination compliance; and the intervention is both minimally infringing and proportionate since it has been balanced by the parents' right to opposition and appeal [ ] . however, the additional child allowance was later cancelled, and the amendment to the israeli social security law was repealed by the israeli parliament before its implementation [ ] . the public health ordinance enacted in , is currently the only reference in israeli law to public health interventions. according to § of the ordinance (which was translated from palestine gazette extraordinary no. of th december, -supplement no. ) "in any town, village or area where an infectious disease assumes or is likely to assume an epidemic character or where there exists in the neighborhood infectious disease such as in the opinion of the director constitutes a danger to the public health of such town, village, or area, the director or medical officer may proceed to take such measures to protect the inhabitants thereof from infection as he considers necessary and may for this purpose inter alia subject the inhabitants of such town, village or area to such prophylactic inoculation or vaccination as in his opinion is necessary to limit the spread of infection. any person who willfully refuses to submit to inoculation or vaccination under this section…is guilty of an offence and is liable to a fine not exceeding five pounds or imprisonment for a term not exceeding one month." § of the ordinance is an emergency powers provision which relates to a formidable epidemic, or to an endemic or infectious disease which threatens "any part of palestine" and empowers the high commissioner to order "any such matters or things as may appear advisable for preventing or mitigating such disease", including "the prophylactic inoculation or vaccination of the general public" [ ] . such mandatory vaccination as provided by the ordinance was only imposed twice in israeli history: once in , when israel faced a smallpox outbreak, and once in when a measles outbreak occurred (mainly in the negev region) [ ] . in light of the above, government intervention in the service of promoting vaccination compliance is thus theoretically justified. however, current israeli law does not follow other jurisdictions with respect to the imposition of sanctions on those who refuse routine vaccination but rather only allows the imposition of sanctions in the specific circumstances provided by the ordinance. was it legally legitimate to impose opvs in in accordance with the public health ordinance, ? as mentioned above, the detection of wild poliovirus in israeli sewage led the ministry of health to initiate a massive public health campaign aimed at persuading parents to vaccinate their children with opv. considering the state comptroller's disapproval of the low compliance rates in certain israeli regions, could the ministry of health have legally considered more intrusive measures of imposing opvs in accordance with the ordinance? the term "epidemic," which justifies the implementation of the public health ordinance and the imposition of mandatory vaccination, refers to "the occurrence in a community or region of cases of an illness, specified health behavior, or other health related events clearly in excess of normal expectancy" [ ] . given that the majority of the israeli population was previously immunized against polio with either opv or ipv, and since no morbidity incidences had occurred since , it may be argued that even one case of morbidity would be "in excess of normal expectancy." the question of whether the detection of wild poliovirus in israeli sewage was also a threat to public health is difficult to answer, as the ordinance does not specify the severity of the risk to public health required for its implementation. according to l.o. gostin, only a "significant" risk should be perceived as a threat to public health, as opposed to a speculative, theoretical or remote risk [ ] . the risk of polio contamination in israel in could have been perceived as significant, as polio viruses are highly contagious and spread by the fecaloral route. although the probability of harm as a result of a polio infection is low, the severity of harm that an unvaccinated individual or an individual with a suppressed immune system may suffer (permanent paralysis) is high. nonetheless, it seems that both § and § of the ordinance authorize the health authorities to impose mandatory vaccination when there is a significant risk to the local population and thus they do not relate to legitimate interventions required for the global eradication of a disease. almost all individuals in israel were protected from the clinical polio disease in [ ] , and there was no risk to the local population (as opposed to the risk of a single case of morbidity). hence, both sections of the ordinance could not provide a legal basis for compulsory opv. would it be legally legitimate to impose opvs in accordance with a new public health law? the israeli association of public health physicians along with the israeli medical association recently made efforts toward the legislation of a new public health law which would replace the antiquated sections of the ordinance (in a manner akin to public health law reforms in other countries as "existing statutes are outdated, contain multiple layers of regulation, and are inconsistent" [ ] ). moreover, the minority opinion in the adalah case held that the entire domain of vaccination should be addressed by new legislation [ ] . it is therefore essential to examine the legitimacy of legislation that would authorize the health officials to not only impose mandatory vaccination where there is a significant risk to the local population (or the risk of an epidemic) but also where the intervention seeks to promote the eradication of a disease. the present examination relates to an obligation which, like § of the ordinance, would be enforced by the criminal sanctions of a financial penalty or imprisonment for no longer than a month. any authorization granted to health officials under a new public health law must comply with the provisions of the basic law: human dignity and liberty. this basic law states that no violation of the life, body or dignity of any person should occur except in accordance with the limitation clause, which will be discussed later. the constitutional right to dignity includes, according to israeli supreme court judgements, the right to autonomy [ ] . one aspect of the right to autonomy is parental autonomy, which refers to parents' right and obligation to take care of their minor children. the rational for parental autonomy is the natural bond between parents and children, and the underlying presumption is that parents will generally make the best decisions for their children. moreover, it is appropriate to let parents decide when they are the ones who will bear the consequences of their decisions [ , ] . do mandatory opvs enforced by criminal sanctions violate the right to parental autonomy? the right to autonomy in the medical context is implemented through the requirement of "informed consent" prior to medical interventions. the "informed consent" doctrine consists of two components: the physician's duty to disclose information about the prospects and risks of the procedure (informed participant) and the patient's right to freely consent or refuse to the treatment (informed choice) [ , ] . it may be argued that this liberal interpretation of bioethics which regulates curative medicine and proceeds from an assumption of absolute bodily autonomy does not apply to public health interventions. childress et al. stated that "it would be a mistake to suppose that respect for autonomy requires consent in all contexts of public health" [ ] . while curative medicine deals with the health of an individual, public health interventions deal with the health of a population. a population's interests may sometimes contradict individual interests and justify interventions which do not assure an individual's consent or despite her or his refusal [ ] [ ] [ ] . moreover, it is unrealistic to obtain informed consent to a public health intervention when the health professional cannot predict whether a specific unvaccinated individual will benefit from the intervention in the future. this is because those members of the population who would stand to gain from the intervention are unknown, and their number can only be estimated in advance [ ] . the legitimacy for exercising state power without receiving "informed consent" derives from social contract theory, which suggests that people agree to accept certain obligations by choosing to live in a society. the presumption of obligation acceptance is based on the "tacit consent" of an individual who resides in the state to government rule in exchange for the benefits of society. other sources for the presumption of obligation acceptance are the "hypothetical consent" of an individual to be bound by the state which is necessary for social functioning, as well as a fairness of balancing the state's benefits to the individual against the limits that are necessary for maintaining those benefits [ , , ] . the israeli supreme court decision in the case of juhar aturi v. the israeli ministry of health ( ) related to the duty to disclose vaccine risks, and held that informed consent for vaccination does not require the disclosure of remote and rare side effects. latter israeli court decisions expanded the duty of disclosure in curative medicine but did not relate to preventive medicine and vaccinations. a limited disclosure requirement might lead to a limited requirement for individual consent to vaccination (or a limited implementation of the informed consent doctrine in public health interventions) as any discussion on the duty of disclosure cannot be separated from a discussion on the right to free consent [ ] . nonetheless, the israeli patient's rights law of espoused the "informed consent" doctrine with respect to both the curative medical context as well as preventive treatment. according to the law, medical treatment, which includes preventive treatment, shall not be given to a patient without her or his "informed consent." a decision by the israeli district court related specifically to vaccination and clearly stated that the "informed consent" requirement applied to a decision on vaccination just as it applied to a decision on any other medical procedure [ ] . the supreme court's decision in the adalah case addressed the circumstances in which the parental autonomy to determine whether or not their children should be vaccinated was violated. the court related to obligatory vaccination enforced through criminal sanctions (whose legitimacy is examined here in the opv context) as hard paternalism (unlike the deduction of an additional child allowance which is soft paternalism). as such, the court held that it violated the right to parental autonomy [ ] . can the violation of parental autonomy be justified in the circumstances? according to john stuart mill, the right to autonomy or parental autonomy (although applicable in public health interventions) is not unlimited: persons should be free to think, speak and behave as they wish, provided they do not interfere with a like expression of freedom by others ("the harm principle") [ ] . l.o. gostin interprets this as suggesting that personal freedoms extend only so far as they do not intrude on the health, safety and other legitimate interests of other individuals. persons, according to gostin, are entitled to live without the risk of serious injury or disease [ , ] . the famous u.s. court decision in jacobson v. massachusetts ( ) followed the millian doctrine and justified a law that mandated vaccination despite restricting liberty: in , massachusetts was the first state in the u.s. to compel vaccination against smallpox. according to the state law, any refusal to the smallpox vaccination resulted in penalties ranging from fines to imprisonment. henning jacobson refused both the vaccination and the payment of a $ fine. jacobson argued before the u.s. supreme court that the massachusetts law violated the due process and equal protection provisions of the fourteenth amendment ("nor shall any state deprive any person of life, liberty or property without due process of law.") jacobson further alleged that it was unreasonable for the state to interfere with his liberty when he had not been taken with any illness. the us supreme court decided in favor of massachusetts in , declaring that the state had the authority to enact health laws of every description to guard the common good in whatever way the citizens, through their elective representatives, thought appropriate: "even liberty itself, the greatest of all rights, is not [an] unrestricted license to act according to one's own will" [ ] . the violation of parental autonomy can be justified according to israeli law if it complies with the stipulations mentioned in the limitation clause ( § of the basic law: human dignity and liberty): the infringement is carried out according to a law befitting the values of the state of israel, is enacted for a proper purpose and to an extent no greater than is required. is a law which authorizes health officials to mandate opvs in order to eradicate polio enacted for a proper purpose? health economists have justified interventions aimed toward increased vaccination coverage through cost-benefit, cost-effectiveness and cost-utility analysestechniques for quantifying and measuring the value of an intervention by weighing the likely costs, including the consequences of adverse events, against the potential positive outcomes. given that the eradication of contagious diseases reduces medical care expenses and adds years of productive life to members of society for a small per-person cost, an increased compliance with opvs with a view to the eradication of polio is considered a proper purpose according to the aforementioned economic-theoretical methods [ , ] . however, economic methods, which help in the determination of public health policy, and especially in cases of limited public health resources, do not reflect moral considerations and preferences that may also justify the violation of individual autonomy. one of these moral considerations is social justice, which is a commitment to the attainment of a sufficient level of health for all [ , ] . the eradication of polio such as would protect the unimmunized population correlates with these social justice values. moreover, the syrian civil war that was still raging in made it increasingly more difficult for syrians to access medical services and vaccines. many syrian residents and refugees were not vaccinated against polio and were at risk of poliovirus infection. the promotion of polio eradication in the region under these circumstances would have the potential of protecting the vulnerable syrian population. protecting population health (as opposed to community health) without national or geographical limitations correlates with the "global justice" which is required in a globalized world where communicable diseases can easily cross borders [ ] . the promotion of polio eradication in israel may also be considered a proper purpose that would justify the infringement of individual autonomy given that the gpeithe global polio eradication initiative spearheaded by national governments, the who, rotary international, the u.s. cdc and unicef supported by the bill and melinda gates foundation have striven toward the eradication of the disease since [ ] . israel is thus morally and politically obliged to participate in the global effort toward the eradication of polio. another case in which a disease was declared as a global health threat by the who was when severe acute respiratory syndrome (sars) was diagnosed in people in countries and caused deaths. china, in which the disease had first been diagnosed, was criticized by the who and by other countries for delays in reporting cases and for a lack of cooperation with the who [ , ] . israel would thus not be able to risk its position as a developed country which cooperates with the global effort toward the eradication of polio. the term "no greater than required," which justifies an intervention despite potentially violating the right to autonomy relates to sub-terms: the effectiveness of the intervention (rational connection); the least infringing intervention, and the proportionality between the benefits from the intervention and the concomitant infringement of human rights. would a mandatory opv be an effective intervention and promote the eradication of polio? in order to determine whether a mandatory opv enforced by criminal sanctions would be an effective intervention, it is necessary to clarify when an intervention meant for the promotion of opv compliance would be considered "effective". as was mentioned above, the ministry of health advised all israeli parents to vaccinate children who were born after with opv in . the public health campaign which followed this recommendation sought to attain maximum compliance. however, the state comptroller criticized the ministry of health for low compliance rates since % of the children born after were vaccinated as well as only % of those children born after and residing in central israel. this begs the question of whether an intrusive intervention would result in higher compliance rates. in this respect, it should be noted that israeli case law suggests that there is no need to prove that the intervention would surely attain its objective, and that it suffices to prove reasonable probability [ ] . the effectiveness of compulsory opvs in israel depends by and large on the reasons for low compliance. low compliance rates which derive from the vaccination hesitancy of israeli parents who seek an open and trusting relationship with their health care providers and who wish to make autonomous decisions regarding vaccination would not be increased by sanctions [ , ] . sanctions would also be certain to provoke israeli parents who already believe that the government is too intrusive with respect to their freedoms as well as parents who are convinced that the vaccine would endanger their child . beside concerns that sanctions would not stimulate hesitant parents as well as parents who oppose government interference, the sanctions' effectiveness would likely be reduced by enforcement difficulties: imposing the obligation to follow, register and report the immunization status of every israeli child would require additional budgetary allocations to the health system. the lack of such an additional budget would interfere with the attainment of the stated objective. over and above budgetary shortfalls, the imposition of sanctions on parents who refuse to vaccinate their children also involves legal and ethical issues associated with the registration of unvaccinated children. the israeli privacy protection law ( ) forbids the disclosure of an individual's private matters (including medical information), although a violation of this privacy is permitted when it is done in accordance with a valid legal provision. the public health ordinance (in § b) authorizes the minister of health to establish a national immunization registry and thus legitimizes the disclosure of vaccination statuses [ ] . however, the ethical dilemma that exists between the violation of healthy people's medical confidentiality and the promotion public health remains and requires an in depth discussion in and of itself. moreover, the registry's legal objectives were the supervision of vaccines administered at public mother and child clinics, hmos (health maintenance organizations) and schools as well as the implementation of § of the national insurance law, which deprived an additional child allowance from the nonvaccinated. the implementation of child allowance reductions is no longer relevant as the associated legal amendment has been repealed. the registry's sole objective at present is thus the supervision of the vaccines administered to the population. using these records in order to impose sanctions on unvaccinated children would deviate from this objective and would very likely provoke opposition [ ] . is a mandatory opv enforced by criminal sanctions the least autonomy-infringing intervention? if we were to overcome parental opposition and enforcement difficulties, and conclude that a mandatory opv would be an effective intervention for promoting compliance and eradicating polio, we must examine whether the enforcement of opvs through criminal sanctions would also be the least autonomy-infringing intervention from an effectiveness perspective. according to childress et al. [ ] , "the fact that a policy will infringe a general moral consideration provides a strong moral reason to seek an alternative strategy that is less morally troubling". reviews of evidence regarding interventions which sought to improve vaccination coverage in children, adolescents and adults, hold that strong scientific evidence supports the assumption that non-intrusive interventions (i.e. client or provider reminder/recall or expanded access to health care settings) can be effective enough in improving vaccination coverage [ ] . in the adalah case [ ] , both justice arbel and justice barak-erez held that deducting an additional child allowance from parents who refuse to vaccinate their children is the least infringing intervention that would promote vaccination compliance, and that a criminal sanction would surely be more intrusive. however, the aforementioned reviews of evidence and the adalah decision relate to routine vaccinations which aim to protect the individual and ensure herd immunity, and do not relate to vaccines recommended for disease eradication where there is no risk of a local outbreak. expecting parents to expose their children to vaccination in order to eradicate a disease worldwide has low prospects given the extent of the expected opposition for an intervention with such remote outcomes. it may therefore be argued that a mandatory opv backed by criminal sanctions would be the least autonomy-infringing intervention necessary for attaining a high degree of compliance. nonetheless, the health authorities must conclude that educating the public regarding all aspects of the importance of polio eradication, including the negative political outcomes of a refusal to participate in the global polio eradication initiative, is ineffective before implementing sanctions (let alone criminal sanctions) against parents who refuse to vaccinate their children with opv. the obligation to use non-intrusive measures before enforcing vaccinations through sanctions accords with the concept of therapeutic jurisprudence (tj), which suggests that legislation should be the last resort after the public has been provided with relevant information such as to build trust and promote compliance [ ] . the requirement of proportionality the discussion above relates to a new public health law that would authorize health officials to enforce a mandatory vaccination in the service of promoting disease eradication and to enforce this obligation throughout a financial penalty or imprisonment of no longer than a month. a financial penalty (unlike the deprivation of freedom) might be considered as a tool for prompting action. however, the proportionality of a decision to convict an individual who refuses vaccination requires a clearing of this individual's criminal record once she or he complies with the obligation to vaccinate. moreover, this provision must also include a procedure which would discuss requests for exemptions. in this respect the granting of exemptions in cases of medical contraindications alone would not diminish the law's proportionality (as the granting of religious or philosophical exemptions might render the law ineffective). nonetheless, a decision to enforce a mandatory opv by a financial penalty in the service of globally eradicating polio even if the aforementioned stipulations are met, might be perceived as incompatible with the violation of the parental autonomy to refuse to altruistically vaccinate a healthy child who is not at risk for a clinical disease (not only was there no risk of a polio outbreak in israel in , but the opv vaccination recommendation was also given to children who had already been vaccinated with ipv and had possessed humoral protection against polio). enforcing the vaccination through a "softer" sanction (i.e. the deprivation of some child benefitsas was suggested in in order to promote compliance with routine vaccination in israel), might not attain a maximum degree effectiveness but would provide parents with the genuine discretion of deciding whether or not to participate in the global eradication efforts, and may thus be considered as proportionate to the concomitant violation of parental autonomy [ ] . the global ambition of eradicating contagious diseases and totally preventing morbidity requires health authority interventions in order to promote vaccination compliance. an examination of the legal legitimacy for a mandatory opv accompanied by criminal sanctions in the service of polio eradication reveals that such intervention would infringe autonomy to an extent greater than required: although eradication is a proper purpose, criminal sanctions might not be effective and may even provoke resistance. moreover, and even if we were to overcome parental opposition and enforcement difficulties, criminal sanctions would still not be the leastinfringing intervention when a public education campaign would achieve the intervention's objectives, and would not be proportionate when the recommended vaccine has remote benefits. the appropriate intervention for promoting vaccination compliance in the service of eradicating contagious diseases should start with nonrestrictive measures such as enhancing the accessibility of vaccination, providing the public with complete and relevant information about the vaccine, or offering incentives to parents who comply with vaccination recommendations. however, in situations where nonrestrictive measures would not suffice in the attainment of health authority objectives, there may be some added value inherent in a law which would authorize it to enforce a mandatory vaccination. such a law should also include several sanctions meant for the enforcement of obligatory vaccination, i.e., tiers of financial sanctions, and the establishment of a criminal record or the quarantine of individuals who refuse vaccination. according to the "intervention ladder" theory [ ], these sanctions should be formulated from least restrictive to most restrictive. such a formulation would in turn require the evaluation of the extent of intrusiveness inherent in every such sanction by experts in law and ethics. the suggested law should further describe the circumstances which justify the implementation of every sanction: a disease in close proximity represents a risk to public health as a significant part of the population is unimmunized; it is necessary for the promotion of compliance with routine vaccination; or the who recommends that the population be vaccinated in the service of promoting global objectives. health authorities should also be granted the discretion to decide on the least restrictive sanction in unexpected circumstances. the terms employed by legislators must also be interpreted. in this respect, and if the law only justifies criminal sanctions when the virus represents a risk to the population, then the term "risk" requires the clarification of its severity and nature, and the term "population" requires the clarification of its geographic borders. the core of the new law should also contain a description of the decision-making process which must be based on facts and which must assure fairness to the individual whose rights are being infringed [ ] . finally, the public should be entitled to participate in the decision-making process or at least be allowed to follow its fully transparent proceedings, since the acquisition of public justification would diminish public resistance to the intervention and consequently increase its effectiveness [ ] . endnotes in environmental samples taken in egypt, israel, the west bank and gaza strip following a polio outbreak in syria. it was noted that a multi-country response was needed despite the fact that polio cases had only been detected in syria, given the ongoing civil war in this country and the mass displacement of its population into neighboring countries. "the primary goal is to ensure that oral polio vaccine (opv) is urgently delivered into all communities" [ ] . sanctions applied against those who refuse vaccination (depriving the right to education) in the us resulted in increased immunization rates [ , , ] . however, given that the majority of the population in israel complies with vaccination recommendations voluntarily, and in light of israeli parents' motivation toward making autonomous decisions, the imposition of a mandatory vaccination may result in resistance and attain the opposite of its intended purpose [ , ] . the enactment of the vaccination act in england ( ), which imposed fines on parents who failed to allow their children to be vaccinated, led to riots in the streets and to serious protests made not only by those opposing the vaccination itself but also by opponents of government intrusion on personal autonomy [ , ] . the work of ensuring that all us students were vaccinated according to school admission laws required the cooperation of both health and education administrators with different priorities. school principals had difficulty keeping track of students' medical records and claimed that budget shortages prevented the implementation of enforcement measures [ ] . gostin suggests that adoption of equally effective and less restrictive alternatives would also encourage voluntary compliance [ ] . imposing tort liability on parents who refuse to vaccinate their children may also encourage vaccination. however, such liability may only be imposed when the parents' choice of non-vaccination results in harm to others. proving that a particular unvaccinated child transmitted a disease to another and caused harm can be a difficult and in some cases an even impossible task [ ] . in the adalah case, justice barak-erez (in ¶ of the court's decision) held that public education was essential to promoting compliance with vaccination, and referred to alberstein m, davidovitch n. .therapeutic jurisprudence and public health: israeli perspectives. bar ilan studies. ; : , which called for the implementation of therapeutic jurisprudence in public health [ ] . the minority opinion in the adalah case considered the partial deprivation of child benefits as a financial sanction which would be legitimate as part of a general piece of legislation that would address vaccination issues [ ] . according to the nuffield council of bioethics, the "intervention ladder" relates to public health interventions in general, and includes both intrusive and nonintrusive interventions which do not require legislation. the law should clarify the risk which justifies a certain sanction according to the mode of transmission, the risk's duration, the probability of harm and the severity of harm [ ] . the israeli mental healthcare law , which replaced a former law passed in , is an example of a statute that balances society's interest in protecting the individual or the public from the symptoms of 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compulsory vaccination and conscientious or philosophical exemptions: past, present and future australian government department of social services. strengthening immunisation for young children advisory committee on infectious diseases and immunization. using registration to state-run nursery schools as a tool for promoting compliance with routine vaccination. ministry of health hcj / adalla legal center v. the israeli ministry of social affairs and social services. nevo legal database isr hcj / adalla legal center v. the israeli ministry of social affairs and social services. nevo legal database isr hcj / adalla legal center v. the israeli ministry of social affairs and social services. nevo legal database isr hcj / adalla legal center v. the israeli ministry of social affairs and social services. nevo legal database isr hcj / adalla legal center v. the israeli ministry of social affairs and social services. nevo legal database isr palestine gazette extraordinary no. of therapeutic jurisprudence and public health when is an epidemic an epidemic? public health law reform hcj / ganem v. the israel bar association. nevo legal database isr lca / attorney general of israel v. zeev acer and beverly cohen. nevo legal database isr a history and theory of informed consent all for one and one for all: informed consent and public health public health ethics: mapping the terrain public health and bioethics public health ethics: from foundations and frameworks to justice and global public health ca / juhar alturi v. the israeli ministry of health ( ) pd isr dc (bs) / haliva eyal v. the israeli health department. nevo legal database isr on liberty private choice versus public health: religion, mortality and childhood vaccination law retaining, and enhancing, the qaly. value health economic analyses of vaccine policies social justice -the moral foundation of public health and health policy what does social justice require for the public's health? public health ethics and policy imperatives challenging inequities in health: from ethics to action strategic plan for polio outbreak ethical and legal challenges posed by severe acute respiratory syndrome hcj / hasan v. the national insurance institute. nevo legal database isr controversies in vaccine mandates. current problems in pediatric and adolescent health care analysis of public responses to preparedness policies: the cases of h n influenza vaccination and gas mask distribution searching eyes -privacy, the state and disease surveillance in america public health: ethical issues the future of communicable disease control: toward a new concept in public health law public health law in a new century part i: law as a tool to advance the community's health low measles incidence: association with enforcement of school immunization laws childhood immunization: laws that work should the uk introduce compulsory vaccination? tort liability for parents who choose not to vaccinate their children and whose unvaccinated children infect others. university of cincinnati law review acknowledgements i gratefully acknowledge the assistance of the vaccination policy research group at tel aviv university's edmond j. safra center as well as prof. nadav davidovitch for comments that greatly improved the manuscript. i also thank the reviewers of this manuscript for their important comments as well as the editors of israel journal of health policy research. no financial support was provided in the preparation of this paper. the dataset that supports the article's conclusions is included within the article itself. • we accept pre-submission inquiries • our selector tool helps you to find the most relevant journal submit your next manuscript to biomed central and we will help you at every step: key: cord- -jdgzx ss authors: machluf, yossy; chaiter, yoram; tal, orna title: gender medicine: lessons from covid- and other medical conditions for designing health policy date: - - journal: world j clin cases doi: . /wjcc.v .i . sha: doc_id: cord_uid: jdgzx ss gender-specific differences in the prevalence, incidence, comorbidities, prognosis, severity, risk factors, drug-related aspects and outcomes of various medical conditions are well documented. we present a literature review on the extent to which research in this field has developed over the years, and reveal gaps in gender-sensitive awareness between the clinical portrayal and the translation into gender-specific treatment regimens, guidelines and into gender-oriented preventive strategies and health policies. subsequently, through the lens of gender, we describe these domains in detail for four selected medical conditions: asthma, obesity and overweight, chronic kidney disease and coronavirus disease . as some of the key gender differences become more apparent during adolescence, we focus on this developmental stage. finally, we propose a model which is based on three influential issues: ( ) investigating gender-specific medical profiles of related health conditions, rather than a single disease; ( ) the dynamics of gender disparities across developmental stages; and ( ) an integrative approach which takes into account additional risk factors (ethnicity, socio-demographic variables, minorities, lifestyle habits etc.). increasing the awareness of gender-specific medicine in daily practice and in tailored guidelines, already among adolescents, may reduce inequities, facilitate the prediction of future trends and properly address the characteristics and needs of certain subpopulations within each gender. buoncervello and colleagues [ ] claimed that "biology of sex differences deals with the study of the disparities between females and males and the related biological mechanisms" where "the term gender refers to a complex interrelation and integration of sex-as a biological and functional determinant and psychological and cultural behaviors (due to ethnical, social or religious background)" as well as aspects related to preferences, views and values. gender differences may also develop and change over time, as they are age-related. biological differences between males and females are apparent even from the early stage of pregnancy, and become more pronounced with development. fundamental gender variation exists not only at the whole organism level, organ system level, organ level, and tissue level but most likely also at the cellular and molecular levels [ , ] . gender differences are manifested in a wide range of fields such as: genetics, anatomy, physiology, biochemistry and metabolism, psychology, nutrition, behavior and sociology, exposure, diet and lifestyle. differences have also been acknowledged in medicine-health status in general, and from disease states (occurrence and severity [ ] ) to drug-related aspects (such as toxicokinetics and toxicodynamics [ ] , as well as pharmacological response [ ] ) and their outcomes in particular. gender medicine focuses on the impact of gender and sex on human physiology, pathophysiology, prognosis, and clinical features (management, treatment and outcome) of diseases that are common to women and men. clinical examples with broad applicability that highlight sex and gender differences in key domains, such as epigenomic modifiers, hormonal milieu, immune function, neurocognitive aging processes, vascular health, response to therapeutics, and interaction with healthcare systems have been recently reviewed [ ] . therefore, here we will try to highlight other aspects, while emphasizing those related to adolescents. there are three main reasons for us to focus on adolescents: ( ) gender differences, including diverse medical differences (developmental/anatomical, physiological, hormonal, psychological, behavioral etc.), become more apparent at this developmental stage; ( ) currently, we believe there is a lack of attention to gender differences at early stages, although those might contribute to gender differences in morbidity at later stages and may allow the medical community to trace the origin of gender differences in old age; and ( ) our vast experience in studying gender-specific medical profiles among adolescents. interest in gender differences related to medical conditions and health status has developed over the years. a search in the pubmed database (https:// pubmed.ncbi.nlm.nih.gov/) revealed a total of publications, the first of them as early as (figure ). while until the mid- s no more than articles were published each year, dozens of articles were published each year during the late s, and the annual numbers steadily grew to over a hundred during the early s, a few hundred during the s, and over one thousand during the early s, reaching approximately and more articles per year in recent years (figure ). while most of the literature revolves around gender differences in the prevalence or incidence of medical conditions, only few studies- publications to be precise-acknowledge gender-specific guidelines ( ) or approaches to treatment ( ) or intervention ( ) of the same medical conditions among males and females. furthermore, even fewer studies- articles-deal with policy ( ) or prevention strategies ( ) related to these gender-specific differences. a similar upward trend has also been observed in the numbers of such studies, yet the first articles were only published during the late s and early s, respectively, and the highest annual publication rates were approximately and , respectively. of note, a significant proportion of these articles only call for action, namely to convert the evidence for gender differences in health status and comorbidities into actual guidelines and treatments, as well as preventive strategies and health policy which is adapted to each figure the annual number or articles publishes in pubmed on gender differences and medical conditions. the annual number of articles on gender differences and medical conditions (black rhombus, continuous line), and the subsets on treatment/intervention/guidelines (dark gray square, dotted line) or health policy/prevention strategies (light gray, dashed line). the exact query searched for the following terms in either the "title" or the "abstract" of the articles: [("gender difference" or "sex difference" or [("sex" or "gender") and "risk factors")] and ("health" or "comorbidities" or "medical conditions") not ("transgender" or "identity" or "orientation")]; the exact query is similar to the first one, including an additional condition: ("treatment" or "intervention" or "guidelines"); the exact query is similar to the first one, including an additional condition: ("policy" or "prevention"). gender, rather than proposing or studying those gender-oriented guidelines, strategies and policies. altogether, these trends suggest an increasing interest in studying differences in the occurrence and severity of health conditions among males and females. following the slow initial accumulation of evidence, and more rapid accumulation in recent years, gender-specific guidelines for treatment or intervention programs have begun to emerge, as well as prevention strategies and health policies that consider each genderdisease pair specifically. there appears to be a fundamental understanding and recognition of the importance of formulating guidelines for treatments and medical policies based on the cumulative information, but in practice this has only been partially realized. a sex-and gender-informed approach promotes discovery and expands the relevance of biomedical research. issues of motivation, subject selection, sample size, data collection, analysis, and interpretation, considering implications for basic, clinical, and population research have been recently addressed and discussed [ ] , as well as the consideration of sex disparities in preclinical studies including in vitro and in vivo approaches [ ] . furthermore, the pursuit of gender differences in biomedical research has gained momentum, based on thoughtful study designs and deliberate methodologies to address gender disparities [ ] . yet, almost simultaneously the premise of personalized medicine [ ] or precision medicine [ , ] has emerged and became more popular, driven by novel and low-cost genetic technologies, rapid advances in computational power, massive, linked databases, and new targeted therapies, in concordance with the rising perception of individualism and patient autonomy. the gender approach in medicine has not been neglected in basic research and applied medicine, but rather it has been (or may be) incorporated into precision medicine approaches [ ] [ ] [ ] [ ] and translational medicine [ ] , or into epidemiological and pathophysiological data as well as into information on treatment options and clinical outcomes [ ] . all these, in turn, may not only shed light on the basis and origin of clinical conditions, but may also shape and dictate actionable guidelines for diagnosis and detection, monitoring, treatment and intervention september , volume issue programs, drug development and administration, and facilitate the design of preventive strategies and health policy, which are all specific to subpopulations with regard to gender (and other factors such as age, risk factors etc.), and even individuals. gender-specific differences in health status have been acknowledged in the occurrence of diverse conditions such as cardiovascular diseases (cvd) [ ] [ ] [ ] [ ] , diabetes [ ] [ ] [ ] [ ] , renal diseases [ ] , asthma [ ] [ ] [ ] , autoimmune diseases [ ] , migraine [ ] , cancer [ ] [ ] [ ] [ ] , spondyloarthritis [ ] , multiple sclerosis [ , ] , alzheimer's disease [ ] [ ] [ ] , sleep apnea and sleep disordered breathing [ ] , epilepsy [ ] , stroke [ ] , autism [ ] , depression [ ] , anxiety [ ] , addiction and substance use [ , ] , and others. calls or recommendations for further studies to establish guidelines for gender-specific treatment and health policy have been recorded in many of these and other fields. nevertheless, they have only been partially realized-in terms of both the medical conditions (in only certain types and to a limited degree) and the target population (mainly among adults and the elderly). hereafter, four medical conditions have been chosen and the diverse aspects of gender differences among children and adolescents-from occurrence to treatment and policy-will be described. the criteria and incentives for choosing the medical conditions-asthma, obesity, chronic kidney disease and covid- were: ( ) conditions which are relatively frequent among adolescents; ( ) conditions that are of great interest to the medical and scientific communities worldwide; ( ) the impact of the condition-both in term of medical aspects, individuals' level of functioning and life quality as well as economic burden on healthcare systems, their preparedness and quality of service-at present on adolescents and in the future, as individuals mature and age, thus providing the opportunity to investigate how gender differences evolve with time, and accordingly to establish gender-sensitive guidelines and policies; ( ) availability of data on gender differences among adolescents; and ( ) our own experience and expertise in studying these conditions with regard to gender-specific medical profiles. of note, not all of the selected conditions answer all of these criteria. we do not aim to provide a comprehensive review on each condition, but to depict key evidence for gender disparities and the existing gap in converting it into genderspecific or gender-adjusted treatment and health policy. asthma is a multifaceted, complex and common chronic respiratory disease that affects over million people worldwide. its prevalence, clinical impact upon quality of life and healthcare expenditure, as well as mortality and morbidity statistics, provide a complete and relevant indication of its significance and global burden [ ] [ ] [ ] . its pathophysiology includes abnormalities of the immune regulation of allergic, inflammatory and neuroendocrine responses [ , ] . it is characterized by intermittent bronchial hyper-responsiveness and reversible airway obstruction, yet presents with multiple clinical forms and levels of severity. a notable sex disparity has been observed in asthma prevalence, incidence, severity, hospitalization rate and duration, being more common and severe in boys during early childhood, equalizing during adolescence, and having female predominance in adulthood [ ] [ ] [ ] [ ] . the role of sex hormones, genetic predisposition and comorbidities in airway inflammation, smooth muscle contraction, mucus production and airway mechanics has been demonstrated [ , ] . delineating the relevant pathways in animal models as well as human subjects with various phenotypes of asthma will help determine whether women with asthma should take (or avoid) hormonal contraceptives as well as predict changes in asthma symptoms during life phases, including pregnancy and menopause, when sex hormone levels change dramatically [ , ] . alongside asthma symptoms and severity, asthma comorbidity also places a significant burden on individuals and the healthcare system with higher rates of hospitalization, emergency department visits and ambulatory care claims among individuals with asthma compared to those without asthma [ ] [ ] [ ] . cross-sectional surveys and small cohorts support the relationship of asthma [ ] [ ] [ ] [ ] [ ] , particularly the severe asthma phenotype [ , ] , with diverse comorbidities such as upper airway diseases, neurologic disorders including migraine [ ] and psychological dysfunction, diverse gastrointestinal diseases, laryngeal dysfunction, pulmonary and bronchial diseases, atherosclerotic cardiac disease and circulatory disorders, dermatologic conditions, connective tissue/rheumatic diseases, metabolic disorders and hormonal imbalance, immunologic and hematologic disease, obesity and overweight [ , ] , sleep apnea and chronic pain conditions. cluster analyses of asthma-related comorbidities have identified diverse profiles and clinical asthma phenotypes in children and adults [ ] [ ] [ ] . these comorbidities have been shown to be more prevalent among asthmatic subjects and some may be related to a more severe form of asthma or refractoriness to treatment, and may influence its clinical manifestation and treatment response, impair health-related quality of life and increase demand on resources. the associations of specific asthma phenotypes with specific comorbidities and their impact on asthma control and management have been investigated [ , , ] , as such comorbidities may be coincidental findings or they may contribute directly to asthma severity [ ] and to the difficult-to-treat phenotype [ ] . however, in most studies the gender approach was not applied. recently, we employed a comparative approach to characterize mild asthma and moderate-to-severe asthma in comparison to subjects without asthma among israeli adolescent males and females separately, while examining secular trends and relationships with sociodemographic variables and anthropometric indices [ ] , as well as coexisting medical conditions [ ] . these studies not only strengthened the growing body of evidence supporting the notion that perhaps different mechanisms and probably etiological bases are involved in the pathogenesis of mild compared to moderate-to-severe asthma, but they also highlighted the differences between young males and females with regard to sociodemographic risk factors associated with asthma development and the medical signature or profile (of either mild or moderateto-severe asthma). a diagnostic and management algorithm for assessing comorbid conditions in patients with severe asthma has been outlined [ ] . additionally, identifying genderspecific risk factors for asthma among both young and adult populations [ ] [ ] [ ] [ ] [ ] may have potential gender-specific diagnostic, therapeutic, prognostic and preventive implications for reducing the burden of asthma itself and its associated comorbidities. these are even more critical considering the "gender shift" in disease occurrence from childhood to adolescence and maturity. nevertheless, despite the vast and diverse body of data on gender-specific differences in asthma development that have accumulated in recent years, data on studies or programs aimed at differentially dealing with asthma among (young or elderly) males and females-from diagnosis, to monitoring the disease and its progression, through investigating possible different treatment managements and responses to drugs, and to preventive strategies and health plans-have not been described. during recent decades, mean body mass index (bmi) and above normal bmi-i.e. overweight and obesity-in children and adolescents-have increased in most countries and regions of the world, among both males and females [ , ] . overweight and obesity are the result of complex relationships between genetic and sociodemographic factors and cultural influences. reduced physical activity, dietary habits and food marketing practices are the most commonly suggested postulated causes of the obesity epidemic, although evidence supporting other putative contributors has also been found [ ] . of note, agreement was sought among six indicators (bmi, triceps and subscapular skinfolds, the sum of four skinfolds, waist circumference and percentage body fat determined by bioelectric impedance analysis) used to classify youth as obese, yet it changes considerably with age and between genders [ ] . it seems that regardless of the threshold or definition, the estimates of severe obesity are higher among boys than among girls [ ] [ ] [ ] , although the evidence is not conclusive [ ] . being overweight or obese in childhood and adolescence is associated with greater risk and earlier onset of chronic disorders such as type diabetes, metabolic syndrome, cvd and a variety of other comorbidities [ , [ ] [ ] [ ] , including hyperlipidemia, hypertension, and abnormal glucose tolerance [ ] . moreover, childhood and adolescent obesity, mainly among girls, is associated with adverse psychosocial consequences [ ] , social exclusion and depression [ , ] , as well as lower educational attainment [ , ] , lower income and increased rates of household poverty [ ] . not only is overweight in adolescent subjects associated with increased risks of adverse health effects-only some of which are common to both males and females, and not to the same extent (see below)-it may also be associated with an increased risk of mortality among men, but not among women [ ] . furthermore, the number of years living with obesity is directly associated with the risk of mortality [ ] . recently, an algorithm that uses combinations of extractable electronic health record indicators and determines provider attention to high bmi and associated medical risk has been developed and validated [ ] . the associations between obesity and a wide range of comorbidities differ between genders, for example: migraine [ ] , depression, eating disorders, anxiety and other mental disorders [ , ] , sleep apnea [ ] , hypertension [ , ] , atrial fibrillation [ ] , certain cancers etc. while most gender-specific differences in obesity-related comorbidities have been investigated and documented in adults, one cannot exclude the possibility that these, at least partially, reflect differences in health problems among obese children and adolescents. profound differences between the medical profiles, or health condition signatures, of obese males and females were recently obtained (alongside common risk factors) for israeli adolescents: obesity was associated with higher risk for hyperlipidemia, diabetes and mental disorders and lower risk for pre-hypertension only in males, whereas it was associated with a higher risk for micro-hematuria only in females, and differences in the magnitude of associations were also demonstrated [ ] . this study not only uncovered novel associations between bmi categories and medical conditions, but also enabled a portrayal of the medical signature of each gender-bmi group, and revealed the gender differences within each bmi category, while providing a broader view on health-status-compromising medical conditions, representing approximately % of all medical conditions among israeli adolescents [ ] . recently, the gender-specific associations between obese adolescents with cardiovascular and non-cardiovascular mortality in midlife were investigated [ ] . furthermore, genderbiased access to deceased donor kidney transplantation was observed among obese patients, as obesity reduces the likelihood of being listed for deceased kidney donor transplantation, especially among women [ ] . altogether, the rising prevalence of elevated bmi and its burden [ ] -in terms of health, social and economic consequences [ , [ ] [ ] [ ] [ ] -highlight the local and international need for a continued focus on the surveillance of bmi and the identification, implementation, and evaluation of evidence-based interventions to address this problem generally, and specifically for each gender. it is widely accepted and recommended that conservative approaches such as intensive, family-based lifestyle modification/behavioral therapy for weight management should be a prerequisite for all obesity-aggressive interventions (including medications and invasive procedures such as bariatric surgeries, gastric bypass, and gastric banding), for the general population, and particularly for children and adolescents [ ] . obesity control and prevention programs in children and adolescents mainly involve diet/nutrition and physical activity, education, multicomponent lifestyle interventions, and community or family involvement or friends' support for eating and exercise [ ] [ ] [ ] [ ] [ ] [ ] [ ] . there is more evidence that obesity prevention programs produce larger effects for females than males [ ] , although this difference is usually non-significant [ ] . moreover, gender differences have also been observed in obese people's preferences, perceived value and willingness to pay for weight loss, lifestyle changes and reduction of long-term risks to health [ ] . for example, female participants providing open-ended responses included wanting to have a baby, not wanting to embarrass their children, physical pain, quality-of-life improvements, and stigma, while males' responses were associated with health insurance coverage and better employment opportunities [ ] . policy makers should assess compliance and prioritize treatment opportunities by analyzing these aspects, and differentially refer young males and females to relevant programs that are adjusted to population characteristics and needs, including gender-related issues. yet, none of this is implemented in practice. specific criteria for integrating overweight into routine preventive screening of adolescents have been determined [ ] , and recommendations that provide practical guidance to pediatric clinicians who evaluate, treat and prevent overweight and obesity in children and adolescents have been developed [ , ] . certain medical associations also provided physicians with a comprehensive and multidisciplinary protocol for guiding and personalizing innovative obesity care for safe and effective weight management [ , ] . yet, none of these guidelines or recommendations consider gender differences. specific national calculations for adolescent obesity plans and policy have been conducted in a number of countries, such as germany [ ] and australia [ ] . policy directives concerning childhood obesity combine medical effectiveness at the individual level with cumulative investment requirements at the population level that are expected to cause growth in healthcare expenditure [ ] . gender differences in the economic impact of obesity have been estimated by quality of life, years of life lost [ ] and hospitalization costs [ ] which are essential for population decision making (in comparison to guidelines to treat the individual patient) and policy. this would provide a platform for priority setting of interventions to prevent and treat obesity, based on value gained for investment, aiming to increase health and reduce costs of secondary implications. social determinants, such as the burden to minorities [ ] , low income countries [ ] or deprived populations, have already been inspected through the gender lens. september , volume issue chronic kidney disease (ckd) is currently defined by abnormalities of kidney structure or function. it is characterized by persistent renal damage and loss of nephron mass and glomerular function that may lead to progressive decline and even loss of renal function over time. the condition may progress from early disease to advanced stages that require kidney replacement therapy (krt) [ ] . this common disorder is a major risk factor for end-stage renal disease (esrd), which is the endpoint of chronic renal disease, as well as cvd. through these effects it contributes markedly to the global burden of morbidity and mortality [ ] . additionally, ckd, especially in later stages, may cause chronic anemia [ ] , mostly due to a lack of erythropoietin, osteoporosis [ ] and cognitive impairment [ ] . it has been recognized as a leading public health problem worldwide. the age-standardized global prevalence of ckd stages - in adults aged and older has been estimated at . % in men and . % in women [ ] , and recently it was updated upwards [ ] . however, the prevalence of ckd shows wide variation between and within specific geographic locations -it is higher especially in low -and middle-income countries-due to both true regional differences in ckd prevalence as well as technical and methodological issues related to measurement and definition [ ] . there is limited epidemiological information on the prevalence and incidence of pediatric ckd, particularly in its early stages, since it is often asymptomatic and therefore under-diagnosed and under-reported [ ] . the currently available data are not only limited but also imprecise, and flawed by methodological differences between the various sources [ ] . in europe, the prevalence of ckd among children aged < ranged from ca. to per million of the agerelated population (registries spanning the period - ), with predominance of males (male/female ratio ranging from . : . to . : . ) [ ] . while in latin america the corresponding prevalence is lower (approximately per million of the age-related population) and data from the middle east are fragmented [ ] , there is actually no comparable information available from the united states [ ] . cobo et al [ ] nicely summarized the issues related to ckd and gender differences: "men and women with ckd differ with regard to the underlying pathophysiology of the disease and its complications, present different symptoms and signs, respond differently to therapy and tolerate/cope with the disease differently". importantly, the lack of inclusion of women in randomized clinical trials in nephrology was noted; therefore, gender differences in ckd pathophysiology, progression, management, treatment and outcome should be carefully considered [ ] . several risk factors in childhood and adolescence have been associated with increased risk for future esrd, including: persistent asymptomatic isolated microscopic hematuria [ ] , hypertension and pre-hypertension [ , ] , overweight and obesity [ , ] , and a history of clinically evident kidney disease in childhood, even if renal function was apparently normal in adolescence [ ] . in all these studies, gender differences, if they existed, were not statistically significant. different gender trajectories of ckd progression in children and adolescents have been reported in a few studies, although the evidence is not conclusive. among glomerular patients, faster progression of ckd was found in females [ ] , whereas among non-glomerular patients no significant gender difference was obtained [ ] or even faster progression of ckd was noted in males [ ] . in adults, women have lower risk of ckd progression, and hence esrd (despite men's lower prevalence of ckd), as well as lower risk of death compared with men [ ] . differences in hormone levels (protective effects of estrogens and/or damaging effects of testosterone) together with unhealthier lifestyles, might cause kidney function to decline faster in men than in women [ , ] . furthermore, hyperuricemia has been shown to be an independent risk factor for faster ckd progression in children and adolescents, but only among males, who seem to tolerate higher levels of uric acid than females [ ] . gender differences in hypertension control, particularly in the early stages of ckd, may also contribute to disparities in ckd progression, as it has been shown that african american men with ckd have poorly controlled hypertension compared with african american women [ ] . gender-specific disparities have also been observed in the treatment of ckd [ , , , ] . more men undergo dialysis or krt than women, despite the fact that more women are affected by ckd, especially stage g ckd. men are also referred earlier for krt than women. the relative difference between men and women initiating and undergoing krt has remained consistent over the last five decades and in all studied countries. yet, the male-to-female ratios, calculated for incident and prevalent krt patients, increase with age, showing consistency over decades and for individual countries. although women are also less likely than men to receive kidney transplants, they are more likely to donate a kidney. additionally, gender differences september , volume issue in preferences have been noticed, as elderly women seem to prefer conservative care over krt. although access to living donor kidneys seems equal, women have reduced access to deceased donor transplantation. dissimilarities between the genders are also apparent in the outcomes of ckd treatment. in patients with pre-dialysis ckd, mortality is higher in men than in women; however, this difference disappears for patients on krt. moreover, quality of life while on krt is poorer in women than in men, as the former report a higher burden of symptoms. effective ckd prevention policies begin with the identification of ckd risk factors in the population, i.e. accurately determining the incidence and prevalence of ckd while considering the distribution and burden of diverse risk factors. then, appropriate targeted mitigation strategies should be developed, including early screening and treatment for populations or individuals with ckd risk to prevent the onset and delay the progression of the kidney disease [ ] . moreover, practical clinical guidelines, a prevention program and policy for ckd management and treatment, as well as research, should stem from an approach that recognizes and addresses ckd as a national public health problem beset by inequities in incidence and prevalence, and complications across gender, as well as other risk factors such as race/ethnicity and ses [ , ] . however, such an approach has been largely neglected [ ] , and all aspects of ckd-from clinical guidelines, through recommendations for management, referral to a preventive program, design of health policy, and research-are made in a genderblind manner [ , ] , despite the wide range of gender disparities related to underlying ckd pathophysiology, disease symptoms and signs, progression and complications, management, response to therapy and its outcome [ ] . policies and public health efforts have not addressed the gender-related impacts of disease outbreaks, which are both physically and socially constructed [ ] . the response to covid- appears no different, as no global health institution or government in any affected country has conducted a gender analysis of the outbreak [ ] . the outburst of a pneumonia-like disease with an unknown etiology in wuhan, china, in mid-late december [ ] [ ] [ ] has become a global pandemic that poses a significant threat to global health [ ] . it was later found to be caused by the pathogen of the coronavirus clade termed severe acute respiratory syndrome coronavirus- (sars-cov- ) [ ] [ ] [ ] [ ] . people at risk for covid- , in terms of disease frequency, mortality or both, have been characterized as having pre-existing diseases such as hypertension, cvd, diabetes, chronic respiratory disease, cancer [ ] , and elevated bmi, mainly obesity [ ] . although the disease has only recently erupted and spread, early studies have already indicated noticeable differences between males and females [ ] . first, there might be a gender predisposition to covid- , with men more prone to being affected [ ] , as male prevalence ranges from approximately % [ , , ] to % [ , ] and up to approximately % [ , ] , depending on the country, disease severity and method of diagnosis. overall, the male to female ratio is . : [ ] , which is quite similar to the ratio detected in the outburst of middle east respiratory syndrome coronavirus (mers-cov) in . the reduced susceptibility of females to viral infections could be attributed to enhanced innate and adaptive immune responses in females driven by chromosome x and sex hormones [ ] , lower density (or expression level) of angiotensin-converting enzyme (ace- ), which is the entry receptor for the covid- virus, in the lungs of females compared to males [ ] , or maybe smoking habits and their effects on increased airway expression of ace [ , ] , although the smoking effect should be validated [ ] . of note, in a few studies the gender differences in the number of cases, if they existed, were not statistically significant [ , , ] , and the differences have been shown to possibly change with age [ ] . in general, only a few studies have provided precise data stratified by age group and gender [ ] ; this may be a major hurdle to evidence-based decision making and policy design [ ] . regardless of susceptibility, there seem to be gender differences in mortality from and vulnerability to the disease [ , ] , as current evidence suggests that male gender is also a risk factor for a worse outcome of covid- . namely, men may be more prone to higher severity and mortality, independent of age, susceptibility and pre-existing comorbid risk factors, among the general infected population [ ] and particularly among severely ill (or worse) patients and those who need management in intensive care units [ , ] and invasive mechanical ventilation [ ] . in contrast, another study found no gender differences among patients in intensive care units or in mortality rate [ ] . furthermore, patients with refractory covid- were also more likely to be males, and male gender also predicted poorer treatment efficacy compared to women [ ] . in addition, indirect effects of covid- also exhibit gender differences. for example, women in the hardest hit areas of china reported significantly higher posttraumatic stress symptoms (ptss), compared to men, during the covid- outbreak [ ] . naturally, most of the research to date has focused on adults and the elderly, who are more prone to and affected by the disease. in general, children are less affected [ , ] and tend to have a milder clinical course, yet the reported proportion of male children is approximately % or higher [ ] [ ] [ ] . data on children and adolescent patients with covid- have just begun to accumulate [ , ] . although data on gender differences are limited, and have not yet been integrated into guidelines and recommendations for disease screening, management and public policy, evidence for the consideration of gender differences has already emerged. for example, exploration of serial intervals, which refers to the time interval from symptom onset of a primary case (infecting) to that of a secondary case (infected), by regression models has accounted for gender-specific differences [ ] . gender has also been integrated into a classifier prediction model to predict the status of recovered and dead covid- patients [ ] . nevertheless, to date, the international and national responses of countries dealing with the covid- pandemic have neither considered nor addressed gender differences such as "gender norms, roles, and relations that influence women's and men's differential vulnerability to infection, exposure to pathogens, and treatment received" [ ] . moreover, these factors may also differ among different groups of women and men, based on age, ethnicity/race, etc. and therefore should also be considered and integrated into guidelines and health policies. herein, we have reviewed diverse aspects of gender-specific differences related to different health conditions among adolescents, and the gap between evidence and its implementation into practical guidelines, recommendations for disease management and design of preventive strategies, and public health policies. in the next section, we provide additional evidence for this gap in diverse domains and discuss the current barriers. then, we highlight a few emerging and influential key themes (detailed below) that should be considered and integrated into a broader approach to gender medicine to inform evidence-based, gender-oriented health policy: ( ) incorporating diverse risk factors (ethnicity, socio-demographic variables, minorities, residence, education, lifestyle habits etc.), in addition to gender, in order to better characterize the needs of sub-populations and properly address their needs; ( ) investigating genderspecific medical profiles of related health conditions, rather than a single disease; ( ) the dynamics of gender disparities across developmental stages; and ( ) the different levels of analysis: individual, communal, regional, national and global levels. lastly, we reflect on this broader approach, and on its application and implications. gender-specific medicine is the study of how diseases differ between men and women in terms of occurrence, clinical signs, therapeutic approach and management, prognosis, psychological and social impact, prevention and research. despite the urgency of basic science and clinical research to increase our understanding of the gender differences of diseases, it is a neglected dimension of medicine and not included in most guidelines [ , ] . to date, some attention to gender differences has been given mainly to certain clinical areas of medicine, many of them related to older populations, such as cvd, oncology, pharmacology, osteoporosis, pulmonary diseases, gastroenterology, hepatology, nephrology, autoimmune diseases, endocrinology, hematology, and neurology [ ] [ ] [ ] . in some of these medical fields, guidelines have been only partially adopted to include a certain degree of gender orientation. however, implementation is still far from optimal. for example, autoimmune hepatitis guidelines are considered gender-specific; however, they are driven by individual genetic fingerprints, and do not draw a clear border between men and women [ ] . existing gender-adjusted treatment guidelines are still not completely applied, for example, guidelines have not been equally implemented for hypertension [ ] , for myocardial infarction [ ] and for acute coronary syndrome [ , ] . access to dialysis treatment and the types of treatments employed for kidney diseases differ by gender [ , ] (as well as by age, race, ethnicity and ses [ , ] ). even if already integrated into current guidelines, such as those of cvd, guidelines still require gender-based revision [ ] . only a small proportion of canadian clinical practice guidelines contain gender-related diagnostic or management recommendations, recommendations for gender-specific laboratory reference values, or refer to differences in epidemiologic features or risk factors [ ] . moreover, developers of clinical practice guidelines have yet to endorse a consistent and systematic approach for considering gender-specific information in these guidelines, such as in the case of cvd [ ] . in addition, epidemiological research data, which are relevant to the local population, and stratified by gender and other key variables, should be transformed from a research setting into a format that could be used by policy developers to support strategies encouraging healthy lifestyle choices and service planning within local government. for instance, data exchange supported by a population statistics company can serve as a conduit to keep regional policy makers informed by local evidence (according to age, sex and residence/suburb), rather than by a national or state health survey, in order to optimize potential intervention strategies [ ] . recently, barriers to the development of sex/gender-sensitive guidelines have been identified [ ] , including the increasing complexity of guidelines, the lack of availability and quality of gender sensitive evidence, the shortage of resources, and deficiencies in awareness/knowledge. in contrast, policies and standards from guideline organizations are conceived as facilitators. addressing these barriers-national/social, organizational and individual ones-may create a basis for potential solutions and tools to achieve behavioral change in the development of gender-sensitive guidelines in the future [ ] . gender-specific healthcare will need to cope not only with clinical-epidemiological aspects, but also with education and preparedness of hospitals, healthcare professionals and the entire healthcare ecosystem. this implies that concepts of sex and gender health should be embedded into medical curricula related to education, training and professionalism of current and future healthcare professionals [ ] , as well as emergency medicine education [ ] , in light of the important implications of gender for changing the clinical practice of emergency care [ ] . a global action initiative was convened as a workshop to assemble the available knowledge on gender-sensitive public health and identify structural influences on practice implementation, resulting in the definition of overarching implementation strategies and principles [ ] . both gender norms [ ] and gender-equality policies [ ] may influence and impact approaches to gender health and women's health throughout their lifetime and gender inequalities in health, including care demands. this may necessitate correction and redesign of gender-equality policies and effective gender-related health policies, as well as health treatment and services for women, which in turn may require additional budgets. men and women are not homogeneous populations due to adverse and combined effects originating from the interplay between genetics, environmental factors and socio-cultural background. however, gender is only one of a few independent risk factors including race/ethnicity, age, and diverse socio-demographic variables (ses, parental education etc.) [ ] [ ] [ ] . lifestyle habits and personal preferences also have an impact on both health status and the entire healthcare system, and influence the demand for healthcare services [ ] . yet, gender is a pivotal risk factor, as epidemiological studies have revealed that gender remains an independent risk factor after ethnicity, age, comorbidities, and scored risk factors are taken into account [ ] . interestingly, interviews with leaders of the israeli healthcare system about their attitude towards inequity and distributed justice of healthcare services revealed the central place of age deprivation (to the elderly), geographic inaccessibility and unbalanced private-public healthcare services, in contrast to gender-that was mentioned by only one expert-among the possible threats to equity in the provision of healthcare [ ] . in addition, most of the literature revolves around gender differences related to a specific medical condition, providing only a narrow view of health status, rather than studying medical profiles of multiple diseases or comorbidities. as most people have more than one single medical condition, one should inspect not only a given medical condition but also its accompanying cluster of associated conditions, namely, the medical condition should be placed in the context of the other co-existing medical conditions at the individual level as well as at the population level. furthermore, little if any attention has been given to the interplay between risk factors such as age-related gender differences, in research and in practical guidelines. this may be due to a lack of evidence, as gender differences become pronounced during adolescence, yet evidence is mainly based on data of adults and the elderly. as physiological, morphological and behavioral and other differences between males and females become more pronounced during puberty, one should not ignore medical differences at this developmental stage. obtaining evidence for gender differences during adolescence, and tracing these to adulthood may provide insights on the origin of these differences and on their change over the course of development. such information may be crucial for the design of specific practical guidelines (for screening, diagnosis, continuous monitoring, and treatment) and preventive programs and health policies among males and females. it can improve individual health status, increase the impact on interventions and policies, and may assist in closing gender disparities at later stages of life. each individual can be observed from different angles: the genetic print, health portrait, sensitivity to exposure, and vulnerability to co-morbidity. the perspective of time over the lifespan-from childhood to old age plays a role in the presentation of health conditions, since age is a major factor in pathophysiology, pharmacodynamics, reaction to treatment and prognosis. but above all, differences between men and women may dramatically affect behavior, responses and outcomes that may be amplified if treated in a non-personalized and gender-insensitive manner. moreover, policy makers and caregivers should observe population trends, or rather the cumulative effect of groups of patients-at national, regional and global levels-stratified by gender, age, ethnicity and other risk factors. this approach will indicate the burden of a disease in a specific manner enabling the definition of targeted guidelines and strategies [ , ] . for instance, a recent study demonstrated the change over time of racial and ethnic disparities in vital care practices and certain outcomes, such as hospital mortality and severe morbidities [ ] . in addition, demographic changes, such as aging populations, impact the entire healthcare system in terms of healthcare service utilization and cost requirements. but demographic changes are also affected by healthcare system output, such as advanced medical care and prevention measures as well as improved health behavior within the population. forecasting future morbidity among diverse population groups is based on population projections, considering demographic changes, and the bi-directional relationship of future morbidity with the healthcare system. such forecasting of probable trends of occurrence rates may enable determination of the measures to be taken within the healthcare system, as well as identification of priorities among population groups [ , ] . previously, we proposed a multi-step model to bridge the gap between data collection on adverse populations, research and informed health decisions and policy making [ ] . it would be tempting to recommend, although too easy and oversimplified, to split the model for males and females in order to generate gender-sensitive health policy. instead, an integrative and broader approach should be applied, integrating all the above-mentioned indicators and processes in a matrix-like manner (figure ) . through this approach, gender is positioned at the top of the hierarchy; below it are other risk factors such as age, race/ethnicity, ses, residence, education, minorities etc. in other words, male and female populations are subdivided by these risk factors, which reflect inequities and diversities, and thus are taken into account. for the grading of each medical condition, within each gender-and preferably also within subpopulations-a multidimensional algorithm should be utilized, while considering occurrence (prevalence, incidence, exposure), progression over time, current and future disease severity (clinical symptoms/signs) and functional disability, psychological and social impact, additional co-existing co-morbidities, medical and economic consequences, mortality rate, preference and response to diverse therapeutic approaches and management protocols, etc. this would sum up to a given score or weight, which reflects the medical condition burden. moreover, the interplay of the medical condition with genetic data as well as epidemiological data on lifestyle habits, environmental factors and socio-cultural background should be assessed. optimally, this would be applied to multiple medical conditions in parallel, so the entire spectrum of medical conditions comprising the health status of a given individual is considered, placing each medical condition in its true context and unraveling the medical profiles or signatures of given subpopulations. for each case the relevance of the data-from the local, to national or global (other september , volume issue figure a broad and integrative approach to generating data on gender differences related to medical profiles across developmental stages and translating the evidence into age-adjusted and gender-oriented clinical guidelines and health policy. countries) populations-should be indicated. obviously, data which are collected routinely should be integrated with evidence from designated research and trials. such a broad, in-depth and tailored evidence base that is stratified to subpopulations within each gender may enable more accurate predictions of the burden of the medical signature-comprising its co-existing comorbidities, which in turn may allow better matching and design of adapted practical guidelines and gender-sensitive health policy. such an integrative approach relies on complex, multi-dimensional regression models and advanced statistics tools and data analysis models (cox proportional hazards e.g.), but can also rely on machine learning and artificial intelligence (ai) learning methods to produce the above-mentioned scores and direct us toward specific measures of intervention treatments and prevention strategies of various medical conditions among male and female subpopulations. the use of ai in the analysis of big data in public health has already been discussed, and methods of approaching big data by machine learning, neural networks and pattern recognition have been suggested in constructing models [ ] . key components september , volume issue of analytics technology and operations, data governance, change and automation, advanced analytics and insights, analytics literacy and strategy and relationship management are of importance in analyzing big data by ai [ ] . the use of ai in the analysis of epidemiological data related to gender, age and morbidity has been demonstrated recently for predictive purposes with implications for patient care, showcasing machine learning classification techniques in lung cancer [ ] , as well as artificial neural network (ann) methods in a nutritional status study [ ] and metabolic syndromes [ ] . these exemplary studies may serve as a proof-of-concept for the feasibility of using ai as a tool in the proposed integrative approach to generating evidence-based, gender-sensitive health policy. therefore, ai and advanced analytics can provide insights into implications for patient care, assist in forecasting future morbidity among diverse population groups, and may enable determination of the measures to be taken within the healthcare system. although the growing body of evidence clearly points to gender-specific differences in diverse range of medical conditions, from chronic disease to pandemics, little has been translated into gender-oriented and adjusted medical guidelines and health policies. an integrative approach to gender medicine-which incorporates information of medical profiles of co-existing medical conditions, considering the dynamics of these profiles across developmental stages, and adjusted to diverse risk factors-was proposed, and may bridge this wide gap. increased awareness of gender-specific differences-in basic and applied research, clinical portrayal, design of treatment regimens and procedures, guidelines, preventive strategies and public health policiesmay improve individualized care, properly 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-segment-elevation myocardial infarction: feasibility and outcomes a conduit between epidemiological research and regional health policy barriers and facilitators for the development of sex/gender sensitive clinical practice guidelines: a qualitative interview study embedding concepts of sex and gender health differences into medical curricula emergency medicine gender-specific education sex as a biological variable in emergency medicine research and clinical practice: a brief narrative review implementation strategies for gender-sensitive public health practice: a european workshop darmstadt gl; gender equality, norms and health steering committee. gender norms and health: insights from global survey data gender policies and gender inequalities in health in europe: results of the sophie project epidemiology and outcomes prevalence, determinants and patterns of multimorbidity in primary care: a systematic review of observational studies risk factors of morbidity among children under age five in ethiopia sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory tract infections in countries: a systematic analysis for the global burden of disease study racial and ethnic differences over time in outcomes of infants born less than weeks' gestation forecasts of morbidity based on population projections: what can health monitoring contribute? artificial intelligence and big data in public health connecting data to value: an operating model for healthcare advanced analytics prediction of lung cancer patient survival via supervised machine learning classification techniques ann prediction of metabolic syndrome: a complex puzzle that will be completed key: cord- -nb j k h authors: loveday, h.p.; wilson, j.a.; pratt, r.j.; golsorkhi, m.; tingle, a.; bak, a.; browne, j.; prieto, j.; wilcox, m. title: epic : national evidence-based guidelines for preventing healthcare-associated infections in nhs hospitals in england date: - - journal: j hosp infect doi: . /s - ( ) - sha: doc_id: cord_uid: nb j k h national evidence-based guidelines for preventing healthcare-associated infections (hcai) in national health service (nhs) hospitals in england were originally commissioned by the department of health and developed during – by a nurse-led multi-professional team of researchers and specialist clinicians. following extensive consultation, they were first published in january ( ) and updated in .( ) a cardinal feature of evidence-based guidelines is that they are subject to timely review in order that new research evidence and technological advances can be identified, appraised and, if shown to be effective for the prevention of hcai, incorporated into amended guidelines. periodically updating the evidence base and guideline recommendations is essential in order to maintain their validity and authority. the department of health commissioned a review of new evidence and we have updated the evidence base for making infection prevention and control recommendations. a critical assessment of the updated evidence indicated that the epic guidelines published in remain robust, relevant and appropriate, but some guideline recommendations required adjustments to enhance clarity and a number of new recommendations were required. these have been clearly identified in the text. in addition, the synopses of evidence underpinning the guideline recommendations have been updated. these guidelines (epic ) provide comprehensive recommendations for preventing hcai in hospital and other acute care settings based on the best currently available evidence. national evidence-based guidelines are broad principles of best practice that need to be integrated into local practice guidelines and audited to reduce variation in practice and maintain patient safety. clinically effective infection prevention and control practice is an essential feature of patient protection. by incorporating these guidelines into routine daily clinical practice, patient safety can be enhanced and the risk of patients acquiring an infection during episodes of health care in nhs hospitals in england can be minimised. we would like to acknowledge the assistance of the infection prevention society, british infection association and the healthcare infection society for their input into the development of these guidelines; and other associations, learned societies, professional organisations, royal colleges and patient groups who took an active role in the external review of the guidelines. we would also like to acknowledge the support received from professor brian duerden cbe in chairing the guideline development advisory group, and carole fry in the chief medical ofÀ cer's team at the department of health (england). the department of health (england). this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. some recommendations from the previous guide lines have been revised to improve clarity; where a new recom mendation has been made, this is indicated in the text. these recommendations are not detailed procedural protocols, and need to be incorporated into local guidelines. none are regarded as optional. standard infection control precautions need to be applied by all healthcare practitioners to the care of all patients (i.e. adults, children and neonates). the recommendations are divided into À ve distinct interventions: • hospital environmental hygiene; • hand hygiene; • use of personal protective equipment (ppe); • safe use and disposal of sharps; and • principles of asepsis. these guidelines do not address the additional infection control requirements of specialist settings, such as the operating department or outbreak situations. the hospital environment must be visibly clean; free from non-essential items and equipment, dust and dirt; and acceptable to patients, visitors and staff. sp levels of cleaning should be increased in cases of infection and/ or colonisation when a suspected or known pathogen can survive in the environment, and environmental contamination may contribute to the spread of infection. the use of disinfectants should be considered for cases of infection and/ or colonisation when a suspected or known pathogen can survive in the environment, and environmental contamination may contribute to the spread of infection. sp shared pieces of equipment used in the delivery of patient care must be cleaned and decontaminated after each use with products recommended by the manufacturer. all healthcare workers need to be educated about the importance of maintaining a clean and safe care environment for patients. every healthcare worker needs to know their speciÀ c responsibilities for cleaning and decontaminating the clinical environment and the equipment used in patient care. hand hygiene sp hands must be decontaminated: • immediately before each episode of direct patient contact or care, including clean/aseptic procedures; • immediately after each episode of direct patient contact or care; • immediately after contact with body Á uids, mucous membranes and non-intact skin; • immediately after other activities or contact with objects and equipment in the immediate patient environment that may result in the hands becoming contaminated; and • immediately after the removal of gloves. use an alcohol-based hand rub for decontamination of hands before and after direct patient contact and clinical care, except in the following situations when soap and water must be used: • when hands are visibly soiled or potentially contaminated with body Á uids; and • when caring for patients with vomiting or diarrhoeal illness, regardless of whether or not gloves have been worn. class a healthcare workers should ensure that their hands can be decontaminated effectively by: • removing all wrist and hand jewellery; • wearing short-sleeved clothing when delivering patient care; • making sure that À ngernails are short, clean, and free from false nails and nail polish; and • covering cuts and abrasions with waterproof dressings. effective handwashing technique involves three stages: preparation, washing and rinsing, and drying. • preparation: wet hands under tepid running water before applying the recommended amount of liquid soap or an antimicrobial preparation. • washing: the handwash solution must come into contact with all of the surfaces of the hand. the hands should be rubbed together vigorously for a minimum of - s, paying particular attention to the tips of the À ngers, the thumbs and the areas between the À ngers. hands should be rinsed thoroughly. • drying: use good-quality paper towels to dry the hands thoroughly. when decontaminating hands using an alcohol-based hand rub, hands should be free of dirt and organic material, and: • hand rub solution must come into contact with all surfaces of the hand; and • hands should be rubbed together vigorously, paying particular attention to the tips of the À ngers, the thumbs and the areas between the À ngers, until the solution has evaporated and the hands are dry. clinical staff should be made aware of the potentially damaging effects of hand decontamination products, and encouraged to use an emollient hand cream regularly to maintain the integrity of the skin. consult the occupational health team or a general practitioner if a particular liquid soap, antiseptic handwash or alcohol-based hand rub causes skin irritation. alcohol-based hand rub should be made available at the point of care in all healthcare facilities. hand hygiene resources and healthcare worker adherence to hand hygiene guidelines should be audited at regular intervals, and the results should be fed back to healthcare workers to improve and sustain high levels of compliance. healthcare organisations must provide regular training in risk assessment, effective hand hygiene and glove use for all healthcare workers. local programmes of education, social marketing, and audit and feedback should be refreshed regularly and promoted by senior managers and clinicians to maintain focus, engage staff and produce sustainable levels of compliance. patients and relatives should be provided with information about the need for hand hygiene and how to keep their own hands clean. patients should be offered the opportunity to clean their hands before meals; after using the toilet, commode or bedpan/urinal; and at other times as appropriate. products available should be tailored to patient needs and may include alcohol-based hand rub, hand wipes and access to handwash basins. selection of personal protective equipment must be based on an assessment of the: • risk of transmission of microorganisms to the patient or carer; • risk of contamination of healthcare practitioners' clothing and skin by patients' blood or body Á uids; and • suitability of the equipment for proposed use. healthcare workers should be educated and their competence assessed in the: • assessment of risk; • selection and use of personal protective equipment; and • use of standard precautions. supplies of personal protective equipment should be made available wherever care is delivered and risk assessment indicates a requirement. gloves must be worn for: • invasive procedures; • contact with sterile sites and nonintact skin or mucous membranes; • all activities that have been assessed as carrying a risk of exposure to blood or body Á uids; and • when handling sharps or contaminated devices. gloves must be: • worn as single-use items; • put on immediately before an episode of patient contact or treatment; • removed as soon as the episode is completed; • changed between caring for different patients; and • disposed of into the appropriate waste stream in accordance with local policies for waste management. hands must be decontaminated immediately after gloves have been removed. a range of ce-marked medical and protective gloves that are acceptable to healthcare personnel and suitable for the task must be available in all clinical areas. sensitivity to natural rubber latex in patients, carers and healthcare workers must be documented, and alternatives to natural rubber latex gloves must be available. disposable plastic aprons must be worn when close contact with the patient, materials or equipment pose a risk that clothing may become contaminated with pathogenic microorganisms, blood or body Á uids. full-body Á uid-repellent gowns must be worn where there is a risk of extensive splashing of blood or body Á uids on to the skin or clothing of healthcare workers. plastic aprons/Á uid-repellent gowns should be worn as single-use items for one procedure or episode of patient care, and disposed of into the appropriate waste stream in accordance with local policies for waste management. when used, nondisposable protective clothing should be sent for laundering. sp fluid-repellent surgical face masks and eye protection must be worn where there is a risk of blood or body Á uids splashing into the face and eyes. appropriate respiratory protective equipment should be selected according to a risk assessment that takes account of the infective microorganism, the anticipated activity and the duration of exposure. respiratory protective equipment must À t the user correctly and they must be trained in how to use and adjust it in accordance with health and safety regulations. personal protective equipment should be removed in the following sequence to minimise the risk of cross/self-contamination: • gloves; • apron; • eye protection (when worn); and • mask/respirator (when worn). hands must be decontaminated following the removal of personal protective equipment. sharps must not be passed directly from hand to hand, and handling should be kept to a minimum. sp needles must not be recapped, bent or disassembled after use. used sharps must be discarded at the point of use by the person generating the waste. all sharps containers must: • conform to current national and international standards; • be positioned safely, away from public areas and out of the reach of children, and at a height that enables safe disposal by all members of staff; • be secured to avoid spillage; • be temporarily closed when not in use; • not be À lled above the À ll line; and • be disposed of when the À ll line is reached. all clinical and non-clinical staff must be educated about the safe use and disposal of sharps and the action to be taken in the event of an injury. sp use safer sharps devices where assessment indicates that they will provide safe systems of working for healthcare workers. organisations should involve end-users in evaluating safer sharps devices to determine their effectiveness, acceptability to practitioners, impact on patient care and cost benefi t prior to widespread introduction. organisations should provide education to ensure that healthcare workers are trained and competent in performing the aseptic technique. the aseptic technique should be used for any procedure that breaches the body's natural defences, including: • insertion and maintenance of invasive devices; • infusion of sterile fl uids and medication; and • care of wounds and surgical incisions. this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. some recommendations from the previous guidelines have been revised to improve clarity; where a new recommen dation has been made, this is indicated in the text. these recommendations are not detailed procedural protocols, and need to be incorporated into local guidelines. none are regarded as optional. these guidelines apply to adults and children aged ≥ year who require a short-term indwelling urethral catheter (≤ days), and should be read in conjunction with the guidance on standard principles. the recommendations are divided into six distinct interventions: • assessing the need for catheterisation; • selection of catheter type and system; • catheter insertion; • catheter maintenance; • education of patients, relatives and healthcare workers; and • system interventions for reducing the risk of infection. only use a short-term indwelling urethral catheter in patients for whom it is clinically indicated, following assessment of alternative methods and discussion with the patient. class d/gpp uc document the clinical indication(s) for catheterisation, date of insertion, expected duration, type of catheter and drainage system, and planned date of removal. uc assess and record the reasons for catheterisation every day. remove the catheter when no longer clinically indicated. assess patient's needs prior to catheterisation in terms of: • latex allergy; • length of catheter (standard, female, paediatric); • type of sterile drainage bag and sampling port (urometer, -l bag, leg bag) or catheter valve; and • comfort and dignity. select a catheter that minimises urethral trauma, irritation and patient discomfort, and is appropriate for the anticipated duration of catheterisation. uc select the smallest gauge catheter that will allow urinary outfl ow and use a -ml retention balloon in adults (follow manufacturer's instructions for paediatric catheters). urological patients may require larger gauge sizes and balloons. uc ensure patients, relatives and carers are given information regarding the reason for the catheter and the plan for review and removal. if discharged with a catheter, the patient should be given written information and shown how to: • manage the catheter and drainage system; • minimise the risk of urinary tract infection; and • obtain additional supplies suitable for individual needs. uc use quality improvement systems to support the appropriate use and management of short-term urethral catheters and ensure their timely removal. these may include: • protocols for catheter insertion; • use of bladder ultrasound scanners to assess and manage urinary retention; • reminders to review the continuing use or prompt the removal of catheters; • audit and feedback of compliance with practice guidelines; and • continuing professional education this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. some recommendations from the previous guidelines have been revised to improve clarity; where a new recommendation has been made, this is indicated in the text. these recommendations are not detailed procedural protocols, and need to be incorporated into local guidelines. none are regarded as optional. ivad healthcare workers caring for patients with intravascular catheters should be trained and assessed as competent in using and consistently adhering to practices for the prevention of catheter-related bloodstream infection. ivad healthcare workers should be aware of the manufacturer's advice relating to individual catheters, connection and administration set dwell time, and compatibility with antiseptics and other Á uids to ensure the safe use of devices. ivad before discharge from hospital, patients with intravascular catheters and their carers should be taught any techniques they may need to use to prevent infection and manage their device. ivad hands must be decontaminated, with an alcohol-based hand rub or by washing with liquid soap and water if soiled or potentially contaminated with blood or body Á uids, before and after any contact with the intravascular catheter or insertion site. ivad use the aseptic technique for the insertion and care of an intravascular access device and when administering intravenous medication. ivad use a catheter with the minimum number of ports or lumens essential for management of the patient. ivad preferably use a designated singlelumen catheter to administer lipidcontaining parenteral nutrition or other lipid-based solutions. ivad use a tunnelled or implanted central venous access device with a subcutaneous port for patients in whom long-term vascular access is required. ivad use a peripherally inserted central catheter for patients in whom mediumterm intermittent access is required. ivad use an antimicrobial-impregnated central venous access device for adult patients whose central venous catheter is expected to remain in place for > days if catheter-related bloodstream infection rates remain above the locally agreed benchmark, despite the implementation of a comprehensive strategy to reduce catheter-related bloodstream infection. ivad in selecting an appropriate intravascular insertion site, assess the risks for infection against the risks of mechanical complications and patient comfort. ivad use the upper extremity for nontunnelled catheter placement unless medically contraindicated. ivad use maximal sterile barrier precautions for the insertion of central venous access devices. ivad when safer sharps devices are used, healthcare workers should ensure that all components of the system are compatible and secured to minimise leaks and breaks in the system. ivad administration sets in continuous use do not need to be replaced more frequently than every h, unless device-speciÀ c recommendations from the manufacturer indicate otherwise, they become disconnected or the intravascular access device is replaced. ivad administration sets for blood and blood components should be changed when the transfusion episode is complete or every h (whichever is sooner). ivad administration sets used for lipidcontaining parenteral nutrition should be changed every h. ivad use quality improvement interventions to support the appropriate use and management of intravascular access devices (central and peripheral venous catheters) and ensure their timely removal. these may include: • protocols for device insertion and maintenance; • reminders to review the continuing use or prompt the removal of intravascular devices; • audit and feedback of compliance with practice guidelines; and • continuing professional education. these are systematically developed broad statements (principles) of good practice. they are driven by practice need, based on evidence and subject to multi-professional debate, timely and frequent review, and modiÀ cation. national guidelines are intended to inform the development of detailed operational protocols at local level, and can be used to ensure that these incorporate the most important principles for preventing hcai in the nhs and other acute healthcare settings. during the past two decades, hcai have become a signiÀ cant threat to patient safety. the technological advances made in the treatment of many diseases and disorders are often undermined by the transmission of infections within healthcare settings, particularly those caused by antimicrobial-resistant strains of disease-causing microorganisms that are now endemic in many healthcare environments. the À nancial and personal costs of these infections, in terms of the economic consequences to the nhs and the physical, social and psychological costs to patients and their relatives, have increased both government and public awareness of the risks associated with healthcare interventions, especially the risk of acquiring a new infection. many, although not all, hcai can be prevented. clinical effectiveness (i.e. using prevention measures that are based on reliable evidence of efÀ cacy) is a core component of an effective strategy designed to protect patients from the risk of infection, and when combined with quality improvement methods can account for signiÀ cant reductions in hcai such as meticillin-resistant staphylococcus aureus (mrsa) and clostridium difÀ cile. these guidelines describe clinically effective measures that are used by healthcare workers for preventing infections in hospital and other acute healthcare settings. three sets of guidelines were developed originally and have now been updated. they include: • standard infection control principles: including best practice recommendations for hospital environmental hygiene, effective hand hygiene, the appropriate use of ppe, the safe use and disposal of sharps, and the principles of asepsis; • guidelines for preventing infections associated with the use of short-term indwelling urethral catheters; and • guidelines for preventing infections associated with the use of intravascular access devices. the evidence for these guidelines was identiÀ ed by multiple systematic reviews of peer-reviewed research. in addition, evidence from expert opinion as reÁ ected in systematically identiÀ ed professional, national and international guidelines was considered following formal assessment using a validated appraisal tool. all evidence was critically appraised for its methodological rigour and clinical practice applicability, and the best-available evidence inÁ uenced the guideline recommendations. a team of specialist infection prevention and control researchers and clinical specialists and a guideline development advisory group, comprising lay members and specialist clinical practitioners, developed the epic guidelines (see sections . and . ). these guidelines can be appropriately adapted and used by all hospital practitioners. this will inform the development of more detailed local protocols and ensure that important standard principles for infection prevention are incorporated. consequently, they are aimed at hospital managers, members of hospital infection prevention and control teams, and individual healthcare practitioners. at an individual level, they are intended to inÁ uence the quality and clinical effectiveness of infection prevention decision-making. the dissemination of these guidelines will also help patients and carers/relatives to understand the standard infection prevention precautions they can expect all healthcare workers to implement to protect them from hcai. each set of guidelines follows an identical format, which consists of: • a brief introduction; • the intervention heading; • a headline statement describing the key issues being addressed; • a synthesis of the related evidence; and • guideline recommendation(s) classiÀ ed according to the strength of the underpinning evidence. a cardinal feature of evidence-based guidelines is that they are subject to timely review in order that new research evidence and technological advances can be identiÀ ed, appraised and, if shown to be effective for the prevention of hcai, incorporated into amended guidelines. the evidence base for these guidelines will be reviewed in years ( ) and the guidelines will be considered for updating approximately years after publication ( ). following publication the dh will ask the advisory group on antimicrobial resistance and healthcare associated infection to advise whether the s h. p. loveday et al. / journal of hospital infection s ( ) s -s evidence base has progressed signiÀ cantly to alter the guideline recommendations and warrant an update. in addition to informing the development of detailed local operational protocols, these guidelines can be used as a benchmark for determining appropriate infection prevention decisions and, as part of reÁ ective practice, to assess clinical effectiveness. they also provide a baseline for clinical audit, evaluation and education, and facilitate on-going quality improvements. there are a number of audit tools available locally, nationally and internationally that can be used to audit compliance with guidance including high-impact intervention tools for auditing care bundles. signiÀ cant additional costs are not anticipated in implement ing these guidelines. however, where current equipment or resources do not facilitate the implementation of the guidelines or where staff levels of adherence to current guidance are poor, there may be an associated increase in costs. given the social and economic costs of hcai, the consequences associated with not implementing these guidelines would be unacceptable to both patients and healthcare professionals. the guidelines were developed using a systematic review process (appendix a. ). in each set of guidelines, a summary of the relevant guideline development methodology is provided. electronic databases were searched for national and international guidelines and research studies published during the periods identiÀ ed for each search question. a two-stage search process was used. for each set of epic guidelines, an electronic search was conducted for systematic reviews of randomised controlled trials (rcts) and current national and international guidelines. international and national guidelines were retrieved and subjected to critical appraisal using the agree ii instrument, an evaluation method used internationally for assessing the methodological quality of clinical guidelines. following appraisal, accepted guidelines were included as part of the evidence base supporting guideline development and, where appropriate, for delineating search limits. they were also used to verify professional consensus and, in some instances, as the primary source of evidence. review questions for the systematic reviews of the literature were developed for each set of epic guideline topics following recommendations from scientiÀ c advisors and the guideline development advisory group. searches were constructed using relevant mesh (medical subject headings) and free-text terms. the following databases were searched: • medline; • cumulated index of nursing and allied health literature; • embase; • the cochrane library; and • psycinfo (only searched for hand hygiene). search results were downloaded into a refworks™ database, and titles and abstracts were printed for review. titles and abstracts were assessed independently by two reviewers, and studies were retrieved where the title or abstract: addressed one or more of the review questions; identiÀ ed primary research or systematically conducted secondary research; or indicated a theoretical/clinical/in-use study. where no abstract was available and the title indicated one or more of the above criteria, the study was retrieved. due to the limited resources available for this review, foreign language studies were not identiÀ ed for retrieval. full-text studies were retrieved and read in detail by two experienced reviewers; those meeting the study inclusion criteria were independently quality assessed for inclusion in the systematic review. included studies were appraised using tools based on systems developed by the scottish intercollegiate guideline network (sign) for study quality assessment. studies were appraised independently by two reviewers and data were extracted by one experienced reviewer. any disagreement between reviewers was resolved through discussion. evidence tables were constructed from the quality assessments, and the studies were summarised in adapted considered judgement forms. the evidence was classiÀ ed using methods from sign, and adapted to include interrupted time series design and controlled before-after studies using criteria developed by the cochrane effective practice and organisation of care (epoc) group (table ) . , this system is similar that used in the previous epic guidelines. the evidence tables and considered judgement reports were presented to the guideline development advisory group for discussion. the guidelines were drafted after extensive discussion. factors inÁ uencing the guideline recommendations included: • the nature of the evidence; • the applicability of the evidence to practice; • patient preference and acceptability; and • costs and knowledge of healthcare systems. the classiÀ cation scheme adopted by sign was used to deÀ ne the strength of recommendation ( these guidelines have been subject to extensive external consultation with key stakeholders, including royal colleges, professional societies and organisations, patients and trade unions (appendix a. ). comments were requested on: • format; • content; • practice applicability of the guidelines; • patient preference and acceptability; and • speciÀ c sections or recommendations. all the comments were collated and sent to the scientiÀ c advisors and the guideline development advisory group for consideration prior to virtual meetings for discussion and agreement on any changes in the light of comments. final agreement was sought from the scientiÀ c advisors and the guideline development advisory group following revision. high-quality meta-analyses, systematic reviews of rcts or rcts with a very low risk of bias + well-conducted meta-analyses, systematic reviews or rcts with a low risk of bias -meta-analyses, systematic reviews or rcts with a high risk of bias* ++ high-quality systematic reviews of case-control or cohort studies. high-quality case-control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal. interrupted time series with a control group: (i) there is a clearly deÀ ned point in time when the intervention occurred; and (ii) at least three data points before and three data points after the intervention + well-conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal. controlled before-after studies with two or more intervention and control sites -case-control or cohort studies with a high risk of confounding or bias and a signiÀ cant risk that the relationship is not causal. interrupted time series without a parallel control group: (i) there is a clearly deÀ ned point in time when the intervention occurred; and (ii) at least three data points before and three data points after the intervention. controlled before-after studies with one intervention and one control site non-analytic studies (e.g. uncontrolled before-after studies, case reports, case series) expert opinion. legislation *studies with an evidence level of ' -' and ' -' should not be used as a basis for making a recommendation. rct, randomised controlled trial. this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. some recommendations from the previous guidelines have been revised to improve clarity; where a new recommendation has been made, this is indicated in the text. these recommendations are not detailed procedural protocols, and need to be incorporated into local guidelines. none are regarded as optional. standard infection control precautions need to be applied by all healthcare practitioners to the care of all patients (i.e. adults, children and neonates). the recommendations are divided into À ve distinct interventions: • hospital environmental hygiene; • hand hygiene; • use of ppe; • safe use and disposal of sharps; and • principles of asepsis. these guidelines do not address the additional infection control requirements of specialist settings, such as the operating department or outbreak situations. this section discusses the evidence upon which recommendations for hospital environmental hygiene are based. the evidence identiÀ ed in the previous systematic review was used as the basis for updating the searches, and searches were conducted for new evidence published since . hospital environmental hygiene encompasses a wide range of routine activities. guidelines are provided here for: • cleaning the general hospital environment; • cleaning items of shared equipment; and • education and training of staff. current legislation, regulatory frameworks and quality standards emphasise the importance of the healthcare environment and shared clinical equipment being clean and properly decontaminated to minimise the risk of transmission of hcai and to maintain public conÀ dence. [ ] [ ] [ ] [ ] [ ] patients and their relatives expect the healthcare environment to be clean and infection hazards to be controlled adequately. the term 'cleaning' is used to describe the physical removal of soil, dirt or dust from surfaces. conventionally, this is achieved in healthcare settings using cloths and mops. dust may be removed using dry dust-control mops/cloths. detergent and water is used for cleaning of soiled or contaminated surfaces, although microÀ bre cloths and water can also be used for surface cleaning. enhanced cleaning describes the use of methods in addition to standard cleaning speciÀ cations. these may include increased cleaning frequency for all or some surfaces, or the use of additional cleaning equipment. enhanced cleaning may be applied to all areas of the healthcare environment or in speciÀ c circumstances, such as cleaning of rooms or bed spaces following the transfer or discharge of patients who are colonised or infected with a pathogenic microorganism. this is sometimes referred to as 'terminal cleaning'. disinfection is the use of chemical or physical methods to reduce the number of pathogenic microorganisms on surfaces. these methods need to be used in combination with cleaning as they have limited ability to penetrate organic material. the term 'decontamination' is used for the process that results in the removal of hazardous substances (e.g. microorganisms, chemicals) and therefore may apply to cleaning or disinfection. research evidence in this À eld remains largely limited to ecological studies and weak quasi-experimental and observational study designs. there is evidence from outbreak reports and observational research which demonstrates that the hospital environment becomes contaminated with microorganisms responsible for hcai. pathogens may be recovered from a variety of surfaces in clinical environments, including those near to the patient that are touched frequently by healthcare workers. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] however, no studies have provided high-quality evidence of direct transmission of the same strain of microorganisms found in the environment to those found in colonised or infected patients. we identiÀ ed one prospective cohort study that found a signiÀ cant independent association between acquisition of two multi-drug-resistant pathogens and a prior room occupant with the same organism [multi-drug-resistant pseudomonas aeruginosa odds ratio (or) . , % conÀ dence interval (ci) . - . , p= . ; multi-drug-resistant acinetobacter baumanii or . , % ci . - . , p= . ] after adjustment for severity of underlying illness, comorbidities, antimicrobial exposure and some other risk factors. a further study reported an association between mrsa and vancomycin-resistant enterococcus (vre), but conclusions that can be drawn from the À ndings are limited by the retrospective study design and lack of adjustment for severity of underlying illness, colonisation pressure and antibiotic exposure. similarly, another retrospective cohort study found an association between acquisition of c. difÀ cile and prior room occupant with the same infection; however, this was based solely on clinical diagnosis rather than active surveillance. many microorganisms recovered from the hospital environment do not cause hcai. cleaning will not completely eliminate microorganisms from environmental surfaces, and reductions in their numbers will be transient. there is some evidence that enhanced cleaning regimens are associated with the control of outbreaks of hcai; however, these study designs do not provide robust evidence of cause and effect. enhanced cleaning has been recommended, particularly 'terminal cleaning', after a bed area has been used by a patient colonised or infected with an hcai. we searched for robust evidence from studies conducted in the healthcare environment which demonstrated cleaning interventions that were associated with reductions in both environmental contamination and hcai. a randomised crossover study of daily enhanced cleaning of high-touch surfaces in an intensive care unit (icu) demonstrated a reduction in the daily number of s sites in a bed area contaminated with mrsa (or . , % ci . - . , p= . ), and the aerobic colony count in communal areas (or . , % ci . - . , p= . ). although the reduction in mrsa in the environment was associated with a large reduction in mrsa contaminating doctors' hands (or . , % ci . - . , p= . ), there was no effect on the incidence of mrsa acquisition by patients (or . , % ci . - . , p= . ). disinfectants have been recommended for cleaning the hospital environment; , however, a systematic review failed to conÀ rm a link between disinfection and the prevention of hcai, although contamination of detergent and inadequate disinfection strength could have been an important confounder. whilst subsequent studies may have demonstrated a link between disinfection and reduced environmental contamination, and sometimes the acquisition of hcai, the study designs are weak with no control groups or randomisation of intervention, and/or the introduction of multiple interventions at the same time. this makes it difÀ cult to draw deÀ nitive conclusions about the speciÀ c effect of disinfection or cleaning. new technologies for cleaning and decontaminating the healthcare environment have become available over the past years, including hydrogen peroxide, and others are in the early stages of development. whilst hydrogen peroxide has been used for decontamination of selected rooms in a us hospital following use by patients with a multi-drug-resistant organism or c. difÀ cile, this study found that it was not possible to use hydrogen peroxide routinely for this purpose. the effectiveness, cost-effectiveness and practicality of this and other new technologies in terms of reducing hcai and routine use in the variety of facilities in uk hospitals has yet to be demonstrated. we identiÀ ed three studies conducted in patient care environments that provided evidence for the effectiveness of different products, containing chemical or other disinfection agents, on environmental contamination but not reductions in hcai. a prospective randomised crossover study provided evidence for the effectiveness of daily cleaning of high-touch surfaces with microÀ bre/copper-impregnated cloths on the reduction of mrsa, as discussed above. an rct demonstrated the efÀ cacy of daily high-touch surface cleaning with peracetic acid on mrsa and c. difÀ cile contamination of the environment, with a signiÀ cant reduction in mrsa and c. difÀ cile isolated from samples taken from surfaces with gloved hands (p< . ) and the hands of healthcare workers ( / in peractic acid group vs / in standard cleaning group, p= . ). a nonrandomised controlled trial (nrct) in two wards at a single hospital provided evidence that an additional cleaner was associated with a . % reduction in environmental microbial contamination of hand-touch sites ( % ci . - . , p< . ) and . % reduction in acquisition of mrsa infection ( % ci . - . , p= . ), although the infection types were not speciÀ ed. hydrogen peroxide has been used as a method of decontamination of the environment in situations where wards/ beds can be closed or left unused for the required period of time [ ] [ ] [ ] we identiÀ ed a prospective, randomised beforeafter study that compared the efÀ cacy of hypochlorite and a hydrogen peroxide decontamination system for terminal cleaning of rooms used by a patient with c. difÀ cile infection in reducing environmental contamination with c. difÀ cile. although both methods reduced environmental contamination signiÀ cantly compared with cleaning alone, hydrogen peroxide achieved a signiÀ cantly greater reduction ( % vs % decrease in proportion of samples with c. difÀ cile, p< . ). a prospective cohort study provided evidence for the efÀ cacy of hydrogen peroxide when used for terminal decontamination after standard cleaning in signiÀ cantly reducing the acquisition of multi-drug-resistant organisms in patients subsequently admitted to the rooms (adjusted incidence rate ratio . , % ci . - . ). however, the effect was mainly driven by reduction in acquisition of vre, and the results could have been confounded by the concurrent implementation of chlorhexidine baths, incomplete surveillance data and nonrandom assignment of rooms to the intervention. the efÀ cacy of antimicrobial surfaces in the clinical environment in reducing surface contamination and hcai is an area of emerging research. four non-randomised, experimental studies, conducted in clinical environments, demonstrated signiÀ cant reductions in microbial burden of between % and % on high-touch surfaces coated with metallic copper and/or its alloys compared with similar noncopper surfaces. [ ] [ ] [ ] [ ] one rct conducted in three icus reported a signiÀ cantly lower acquisition of hcai in patients allocated to rooms with six high-touch copper-coated surfaces ( . % vs . %, p= . ). a multi-variate analysis suggested that both severity of underlying illness and room assignment were independently associated with the acquisition of hcai or colonisation. however, these À ndings may have been biased by poor discrimination of patients colonised on admission because of limited surveillance cultures, poor agreement in deÀ ning cases of hcai, and incomplete adjustment for confounders in the multi-variate analysis. evidence of the effectiveness and cost-effectiveness of these technologies and their contribution to reductions in hcai is therefore not currently available. indicators of cleanliness based on levels of microbial or adenosine triphosphate (atp) contamination have been recommended; however, relationships between atp and aerobic colony counts are not consistent, and neither method distinguishes normal environmental Á ora and pathogens responsible for hcai. , benchmark values of between and relative light units have been proposed as a more objective measure of assessing the efÀ cacy of cleaning than visual assessment, although these are based on arbitrary standards of acceptable contamination that have not been shown to be associated with reductions in hcai. [ ] [ ] [ ] we identiÀ ed a number of uncontrolled before-after studies that used atp in various forms to highlight the extent of contamination of the healthcare environment. in addition, some studies described the use of atp monitoring as an intervention to improve cleaning, but the lack of a control group in the study design precluded their inclusion in this review. as cleaning will only have a transient effect on the numbers of microorganisms, regular cleaning or disinfection of hospital surfaces will not guarantee a pathogenfree environment. preventing the transfer of pathogens from the environment to patients therefore still depends on ensuring that hands are decontaminated prior to patient contact. the hospital environment must be visibly clean; free from non-essential items and equipment, dust and dirt; and acceptable to patients, visitors and staff. sp levels of cleaning should be increased in cases of infection and/ or colonisation when a suspected or known pathogen can survive in the environment, and environmental contamination may contribute to the spread of infection. the use of disinfectants should be considered for cases of infection and/ or colonisation when a suspected or known pathogen can survive in the environment, and environmental contamination may contribute to the spread of infection. shared clinical equipment used to deliver care in the clinical environment comes into contact with intact skin and is therefore unlikely to introduce infection directly. however, it can act as a vehicle by which microorganisms are transferred between patients, which may subsequently result in infection. equipment should therefore be cleaned and decontaminated after each use with cleaning agents compatible with the piece of equipment being cleaned. in some outbreak situations, the use of chlorine-releasing agents and detergent should be considered. [ ] [ ] [ ] [ ] sp shared pieces of equipment used in the delivery of patient care must be cleaned and decontaminated after each use with products recommended by the manufacturer. in a systematic review of healthcare workers' knowledge about mrsa and/or frequency of cleaning practices, three studies indicated that staff were not using appropriate cleaning practices with sufÀ cient frequency to ensure minimisation of mrsa contamination of personal equipment. staff education was lacking on optimal cleaning practices in the clinical areas. the À nding of the review is reinforced by a later observational study, which noted that lapses in adherence to the cleaning protocol were linked with an increase in environmental contamination with isolates of a. baumannii. a second systematic review of four cohort studies that compared the use of detergents and disinfectants on microbial-contaminated hospital environmental surfaces suggested that a lack of effectiveness was, in many instances, due to inadequate strengths of disinfectants, probably resulting from a lack of knowledge. we identiÀ ed no new, robust research studies of education or system interventions for this review. however, creating a culture of responsibility for maintaining a clean environment and increasing knowledge about how to decontaminate equipment and high-touch surfaces effectively requires education and training of both healthcare cleaning professionals and clinical staff. all healthcare workers need to be educated about the importance of maintaining a clean and safe care environment for patients. every healthcare worker needs to know their speciÀ c responsibilities for cleaning and decontaminating the clinical environment and the equipment used in patient care. total number of articles located = abstract indicates that the article: relates to infections associated with hospital hygiene; is written in english; is primary research, a systematic review or a meta-analysis; and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text conÀ rms that the article: relates to infections associated with hospital hygiene; is written in english; is primary research (randomised controlled trials, prospective cohort, interrupted time series, controlled before-after, quasi-experimental, experimental studies answering speciÀ c questions), a systematic review or a meta-analysis including the above designs; and informs one or more of the review questions. total number of studies selected for appraisal during sift = all articles that described primary research, a systematic review or a meta-analysis and met the sift criteria were independently critically appraised by two appraisers using sign and epoc criteria. consensus and grading was achieved through discussion. total number of studies accepted after critical appraisal = total number of studies rejected after critical appraisal = this section discusses the evidence for recommendations concerning hand hygiene practice. designing and conducting robust, ethical rcts in the À eld of hand hygiene is challenging, meaning that recommendations are based on evidence from nrcts, quasi-experimental studies, observational studies and laboratory studies with volunteers. in addition, expert opinion derived from systematically retrieved and appraised professional, national and international guidelines is used. the areas discussed in this section include: • assessment of the need to decontaminate hands; • efÀ cacy of hand decontamination agents and preparations; • rationale for choice of hand decontamination practice; • technique for hand decontamination; • care required to protect hands from the adverse effects of hand decontamination practice; • promoting adherence to hand hygiene guidelines; and • involving patients and carers in hand hygiene. the transfer of organisms between humans can occur directly via hands, or indirectly via an environmental source (e.g. commode or wash basin). epidemiological evidence indicates that hand-mediated transmission is a major contributing factor in the acquisition and spread of infection in hospitals. , , the hands are colonised by two categories of microbial Á ora. the resident Á ora are found on the surface, just below the uppermost layer of skin, are adapted to survive in the local conditions and are generally of low pathogenicity, although some, such as stapylococcus epidermidis, may cause infection if transferred on to a susceptible site such as an invasive device. the transient Á ora are made up of microorganisms acquired by touching contaminated surfaces such as the environment, patients or other people, and are readily transferred to the next person or object touched. they may include a range of antimicrobial-resistant pathogens such as mrsa, acinetobacter or other multi-resistant gram-negative bacteria. if transferred into susceptible sites such as invasive devices or wounds, these microorganisms can cause life-threatening infections. transmission to non-vulnerable sites may leave a patient colonised with pathogenic and antibiotic-resistant organisms, which may result in an hcai at some point in the future. outbreak reports and observational studies of the dynamics of bacterial hand contamination have demonstrated an association between patient care activities that involve direct patient contact and hand contamination. , [ ] [ ] [ ] [ ] the association between hand decontamination, using liquid soap and water and waterless alcohol-base hand rub (abhr), and reductions in infection have been conÀ rmed by clinically-based nonrandomised trials , and observational studies. , current national and international guidance has consistently identiÀ ed that effective hand decontamination results in signiÀ cant reductions in the carriage of potential pathogens on the hands, and therefore it is logical that the incidence of preventable hcai is decreased, leading to a reduction in patient morbidity and mortality. patients are put at risk of developing an hcai when informal carers or healthcare workers caring for them have contaminated hands. decontamination refers to a process for the physical removal of dirt, blood and body Á uids, and the removal or destruction of microorganisms from the hands. the world health organization's (who) 'five moments for hand hygiene' provides a framework for training healthcare workers, audit and feedback of hand hygiene practice, and has been adopted without modiÀ cation in many countries and adapted in others (e.g. canada). hands must be decontaminated at critical points before, during and after patient care activity to prevent crosstransmission of microorganisms. , , , evidence considered by the national institute for health and clinical excellence (nice) indicated increases in hand decontamination compliance before and after patient contact associated with implementation of the who 'five moments' and us centers for disease control and prevention guidelines, but no difference in compliance after contact with patient surroundings. the following recommendations are derived from the who framework and nice guidelines, and include additional points of emphasis. hands must be decontaminated: • immediately before each episode of direct patient contact or care, including clean/aseptic procedures; • immediately after each episode of direct patient contact or care; • immediately after contact with body Á uids, mucous membranes and non-intact skin; • immediately after other activities or contact with objects and equipment in the immediate patient environment that may result in the hands becoming contaminated; and • immediately after the removal of gloves. current national and international guidelines , , consider the efÀ cacy of various preparations for the decontamination of hands using liquid soap and water, antiseptic handwash agents and abhr in laboratory studies and their effectiveness in clinical use. overall, there is no compelling evidence to favour the general use of antiseptic handwashing agents over liquid soap or one antiseptic agent over another. , , , all hand hygiene products for use in clinical care must comply with current british standards. many studies have been conducted during the past years to compare hand hygiene preparations, including abhr and gels, antiseptic handwash and liquid soap. rcts and other quasiexperimental studies have generally demonstrated alcoholbased preparations to be more effective hand hygiene agents than non-medicated soap and antiseptic handwashing agents, although a small number of studies reported no statistically signiÀ cant difference. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] many of these studies involved the use of abhr as part of a number of interventions, or multimodal campaigns, to improve hand hygiene practice, and had methodological Á aws that weaken the causal relationship between the introduction of abhr and reductions in hcai. we identiÀ ed one multi-variate, interrupted time series which suggested that the amount of abhr used per patientday was the only factor associated with a reduction in mrsa incidence density (p= . ) in a neonatal icu in japan. incidence density fell over a -year period from an average of per patient-days, with a peak of per patientdays in august , to per patient-days in october and was sustained to july (average incidence density . per patient-days). the supporting evidence from laboratory studies of the efÀ cacy of abhr indicates that these products are highly effective at reducing hand carriage, whilst overcoming some of the recognised barriers to handwashing; most importantly, the ease of use at the point of patient care. these studies underpin a continuing trend to adopt abhr for routine use in clinical practice. however, some studies highlight the need for continued evaluation of the use of abhr within the clinical environment to ensure staff adherence to guidelines and effective hand decontamination technique. , choosing the method of hand decontamination will depend upon the assessment of what is appropriate for the episode of care, the availability of resources at or near the point of care, what is practically possible and, to some degree, personal preferences based on the acceptability of preparations or materials. in general, effective handwashing with liquid soap and water or the effective use of abhr will remove transient microorganisms and render the hands socially clean. the effective use of abhr will also substantially reduce resident microorganisms. this level of decontamination is sufÀ cient for general social contact and most clinical care activities. , , liquid soap preparations that contain an antiseptic affect both transient microorganisms and resident Á ora, and some exert a residual effect. the use of preparations containing an antiseptic is required in situations where prolonged reduction in microbial Á ora on the skin is necessary (e.g. surgery, some invasive procedures or in outbreak situations). , , abhr is not effective against all microorganisms (e.g. some viruses such as norovirus and spore-forming microorganisms such as c. difÀ cile). it will not remove dirt and organic material, and may not be effective in some outbreak situations. , we identiÀ ed two laboratory studies which demonstrated that abhr was not effective in removing c. difÀ cile spores from hands. , in the À rst study, a comparison of liquid soap and water, chlorhexidine gluconate (chg) soap and water, antiseptic hand wipes and abhr resulted in all the soap and water protocols yielding greater mean colony-forming unit (cfu) reductions, followed by the antiseptic hand wipes, than abhr. abhr was equivalent to no intervention ( . log cfu/ml, % ci - . to . log cfu/ml). in the second study, three abhr preparations with a minimum % alcohol s concentration were compared with antiseptic (chg) soap and water. antiseptic soap and water reduced spore counts signiÀ cantly compared with each of the abhrs (chg vs isagel, p= . ; chg vs endure, p= . ; chg vs purell, p= . ). in addition, % of the residual spores were readily transferred by handshake following the use of abhr. recent evidence from a laboratory study that compared the efÀ cacy of liquid soap and water and abhr with and without chg against h n inÁ uenza virus demonstrated that all the hand hygiene protocols were effective in reducing virus copies. a further study that compared the use of liquid soap and water and % ethanol hand sanitisers for the removal of rhinovirus indicated that the hand sanitisers were more effective than soap and water. two economic evaluations from the usa, included in recent nice primary care guidelines, suggest that non-compliance with hand hygiene guidelines results in increased infection-related costs. although compliance increases procurement costs of hand hygiene products, even a small increase in compliance is likely to result in reduced infection costs. we identiÀ ed a further economic analysis of a hand hygiene programme based on the introduction of point-of-use abhr and associated implementation materials. this demonstrated a reduction in episodes of hcai and a saving of $ . for every $ spent on the programme when future costs were considered. sensitivity analyses showed that the programme remained cost saving in all alternative scenarios. abhr is likely to be less costly and result in greater compliance. national and international guidelines suggest that the acceptability of agents and techniques is an essential criterion for the selection of preparations for hand hygiene. , , acceptability of preparations is dependent upon the ease with which the preparation can be used in terms of time and access, together with their dermatological effects. abhr is preferable for routine use due to its efÀ cacy, availability at the point of care and acceptability to healthcare workers. however, abhr does not remove organic matter and is ineffective against some microorganisms; therefore, handwashing is required. use an alcohol-based hand rub for decontamination of hands before and after direct patient contact and clinical care, except in the following situations when soap and water must be used: • when hands are visibly soiled or potentially contaminated with body Á uids; and • when caring for patients with vomiting or diarrhoeal illness, regardless of whether or not gloves have been worn. investigations of technique for hand decontamination are limited and generally laboratory-based or small-scale observational designs. hand hygiene technique involves both the preparation and the physical process of decontamination. , , hands and wrists need to be fully exposed to the hand hygiene product and therefore should be free from jewellery and long-sleeved clothing. a number of small-scale observational studies have demonstrated that wearing rings and false nails is associated with increased carriage of microorganisms and, in some cases, linked to the carriage of outbreak strains. department of health guidance on uniforms and work wear and nice guidelines indicate that healthcare workers should remove rings and wrist jewellery, and wear short-sleeved clothing whilst delivering patient care. , evidence for the duration of hand decontamination has been considered in previous systematic reviews underpinning guidelines, and suggests that different durations of handwashing and hand rubbing do not signiÀ cantly affect the reduction of bacteria. , the who guidelines indicate that decontamination using abhr should take - s for a seven-step process, and that handwashing should take - s for a nine-step process. we identiÀ ed one recent rct in a single hospital which demonstrated that allowing staff to decontaminate their hands 'in no particular order' took less time and was as effective as using the who seven-step technique using abhr or liquid antimicrobial soap and water (p= . and p< . , respectively). all three of the protocols tested in this study were effective in reducing hand bacterial load (p< . ). a similar result was reported by authors of a laboratory study that tested the en six-step technique against a range of other protocols. they reported that allowing volunteers to use their own 'responsible application' or a new À ve-step technique resulted in better coverage of the hands during hand decontamination. a number of laboratory-based studies that investigated methods of hand drying suggested that there is no signiÀ cant difference in the efÀ cacy of different methods of drying hands, but that good-quality paper towels dry hands efÀ ciently and remove bacteria effectively. , current guidance on infection control in the built environment suggests that air and jet driers are not appropriate for use in clinical areas. we identiÀ ed one systematic review of studies on hand drying that failed to meet the quality criteria for inclusion. due to the methodological limitations of studies, evidence recommendations are based on national and international guidelines which state that the duration of hand decontamination, the exposure of all aspects of the hands and wrists to the preparation being used, the use of vigorous rubbing to create friction, thorough rinsing in the case of handwashing, and ensuring that hands are completely dry are key factors in effective hand hygiene and the maintenance of skin integrity. healthcare workers should ensure that their hands can be decontaminated effectively by: • removing all wrist and hand jewellery; • wearing short-sleeved clothing when delivering patient care; • making sure that À ngernails are short, clean, and free from false nails and nail polish; and • covering cuts and abrasions with waterproof dressings. effective handwashing technique involves three stages: preparation, washing and rinsing, and drying. • preparation: wet hands under tepid running water before applying the recommended amount of liquid soap or an antimicrobial preparation. • washing: the handwash solution must come into contact with all of the surfaces of the hand. the hands should be rubbed together vigorously for a minimum of - s, paying particular attention to the tips of the À ngers, the thumbs and the areas between the À ngers. hands should be rinsed thoroughly. • drying: use good-quality paper towels to dry the hands thoroughly. when decontaminating hands using an alcohol-based hand rub, hands should be free of dirt and organic material and: • hand rub solution must come into contact with all surfaces of the hand; and • hands should be rubbed together vigorously, paying particular attention to the tips of the À ngers, the thumbs and the areas between the À ngers, until the solution has evaporated and the hands are dry. expert opinion suggests that skin damage is generally associated with the detergent base of the preparation and/or poor handwashing technique. , , , in addition, the frequent use of some hand hygiene agents may cause damage to the skin and alter normal hand Á ora. sore hands are associated with increased colonisation by potentially pathogenic microorganisms and increase the risk of transmission. , , , the irritant and drying effects of liquid soap and antiseptic soap preparations have been identiÀ ed as one of the reasons why healthcare practitioners fail to adhere to hand hygiene guidelines. , , , , in addition, washing hands regularly with liquid soap and water before or after the use of abhr is associated with dermatitis and is not necessary. systematic reviews conducted to underpin national guidelines , , , , have identiÀ ed a range of studies that compared the use of alcohol-based preparations with liquid soap and water using self-assessment of skin condition by nurses. these studies found that abhr was associated with less skin irritation than liquid soap and water. , , , , [ ] [ ] [ ] in addition, a longitudinal study of the introduction and subsequent use of abhr over a -year period observed no reports of irritant and contact dermatitis associated with the use of abhr. we identiÀ ed a recent study which suggested that two abhr preparations containing a glycerol emollient were more acceptable to staff (p< . ). hand moisturisers/ emollients that are for shared use are more likely to become contaminated, and have been associated with an outbreak of infection in a neonatal unit. current national and international guidance suggests that skin care, through the appropriate use of hand lotion or moisturisers added to hand hygiene preparations, is an important factor in maintaining skin integrity, encouraging adherence to hand decontamination practices and assuring the health and safety of healthcare practitioners. , , clinical staff should be made aware of the potentially damaging effects of hand decontamination products, and encouraged to use an emollient hand cream regularly to maintain the integrity of the skin. consult the occupational health team or a general practitioner if a particular liquid soap, antiseptic handwash or alcohol-based hand rub causes skin irritation. national and international guidelines emphasise the importance of adherence to hand hygiene guidance, and provide an overview of the barriers and factors that inÁ uence hand hygiene compliance. , , , the use of multi-modal approaches to improving hand hygiene practice and behaviour has been advocated for over years. observational studies have consistently reported an association between multi-modal interventions involving the introduction of near-patient abhr, audit and feedback, reminders and education, and greater compliance by healthcare staff. , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] an early systematic review of studies involving interventions to improve hand hygiene compliance concludes that: • single interventions have a short-term inÁ uence on hand hygiene; • reminders have a modest but sustained effect; • feedback increases rates of hand hygiene but must be regular; • near-patient alcohol-based preparations improve the frequency with which healthcare workers clean their hands; and • multi-faceted approaches have a more marked effect on hand hygiene and rates of hcai. h. p. loveday et al. / journal of hospital infection s ( ) s -s national hand hygiene campaigns have been modelled on the multi-modal approach and implemented across the world. , , , in england and wales, the national patient safety agency's 'cleanyourhands campaign' was piloted and implemented between and with the aim of creating sustainable change in hand hygiene compliance. the campaign comprised the use of near-patient abhr, national poster materials, audit and feedback, and materials for patient engagement. recent cochrane reviews of randomised and controlled clinical trials, interrupted time series and controlled before-after studies have suggested that the majority of studies conducted in this À eld have methodological biases that exclude them from this review. , we identiÀ ed four systematic reviews of interventions to improve hand hygiene compliance. , [ ] [ ] [ ] the most recent cochrane review identiÀ ed studies published after for potential inclusion, but only four studies (one rct, two interrupted time series and one controlled before-after study) were included following detailed quality assessment. the heterogeneity of interventions and methods precluded the pooling and meta-analysis of results, and it was concluded that multi-faceted campaigns that include social marketing or staff engagement may be more effective than campaigns without these components, and that education or product substitution alone were less effective. an integrative systematic review of studies that reported a wide range of interventions, including multi-modal interventions and hand hygiene product changes, only scored nine of the included studies as having limited or no fatal Á aws. the authors concluded that design limitations made it difÀ cult to generalise the study results or isolate the speciÀ c effects of hand hygiene (or other interventions) on reductions in hcai. an earlier systematic review of 'bundled' behavioural intervention studies that reported hcai or rates of colonisation as the primary outcome identiÀ ed potential studies for inclusion; of these, only four had quality scores > %. again, due to the heterogeneity of study interventions and outcomes, the results were narratively synthesised. the authors concluded that the formation of multi-disciplinary quality improvement teams and educational interventions might be effective strategies to improve hand hygiene and reduce rates of hcai. the À nal systematic review focused speciÀ cally on educational interventions to improve hand hygiene compliance and competence in hospital settings, and included all study designs that reported at least one outcome measure of hand hygiene competence and had a follow-up of at least months. thirty studies met the inclusion criteria for the review, but it was not possible to separate competence from compliance. educational interventions taught or re-taught the correct methods for hand hygiene and then assessed compliance. the authors concluded that educational interventions had a greater impact if compliance with hand hygiene was low. multiple interventions were better than single interventions in sustaining behaviour change, as were continuous, rather than one-off, interventions. however, it was not possible to determine the duration or sustainability of behaviour change in these studies. we identiÀ ed six new studies in our systematic review: one cluster rct and process evaluation, , one step-wedge cluster rct, two interrupted time series studies , and one controlled before-after study that evaluated multi-modal interventions with varying components. in a cluster rct that also included a process evaluation, the authors tested a set of core elements in a 'state-of-the-art strategy' (sas) against a team-leader-directed strategy (tds) at baseline (t ), immediately following the intervention (t ) and months later (t ) to ascertain the additional beneÀ ts of leadership and staff engagement components. , in the intention-to-treat analysis (itt), an or of . ( % ci . - . , p< . ) in favour of the tds between t and t suggested that engaging ward leadership and the involvement of teams in setting norms and targets resulted in greater compliance with hand hygiene. however, there was no signiÀ cant difference between the groups' compliance at t in the itt (p= . ), with the sas also having a sustained effect. the process evaluation examined the extent to which the content, dosage and coverage of the intervention had been delivered. an as-treated analysis demonstrated a greater effect size for the tds at t with a signiÀ cant difference in hand hygiene compliance (p< . ). the process evaluation also suggested that feedback about individual hand hygiene performance at t and t (p< . and p< . , respectively), challenging colleagues on undesirable hand hygiene practice (p< . ), and support from colleagues in performing hand hygiene (p< . ) were positively correlated with changes in nurses' hand hygiene compliance. the second cluster rct used a step-wedge design to assess a behavioural feedback intervention in intensive therapy units (itus) and acute care of the elderly (ace) wards at sites participating in the 'cleanyourhands campaign'. the primary and secondary outcome measures were hand hygiene compliance measured by covert direct observation for h every weeks, and soap and abhr procurement, respectively. sixty wards were recruited, of which implemented the intervention. the itt analysis ( wards) showed a signiÀ cant effect of the intervention in the itus but not the ace wards, equating to a - % increase in compliance, with estimated or of . ( % ci . - . , p=< . ) in itus and estimated or of . ( % ci . - . , p= . ) in ace wards. the perprotocol analysis ( wards) showed a signiÀ cant increase in compliance in both ace wards and itus of - % and - %, respectively, with estimated or of . ( % ci . - . , p . ) in ace wards and estimated or of . ( % ci . - . , p . ) in itus. the authors concluded that individual feedback and team action planning resulted in moderate but sustained improvements in hand hygiene adherence. the difÀ culties in implementing this intervention point to the problems that might be faced in a non-trial context. two interrupted time series studies of the -year national 'cleanyourhands campaign' in england and a -year hospitalwide programme in taiwan demonstrated increased hand hygiene compliance (measured by procurement of abhr and liquid soap) and reductions in hcai [mrsa and c. difÀ cile, and mrsa and extensively-drug-resistant acinetobacter (xdrab)]. , in the national study, increased procurement of soap was independently associated with reductions in c. difÀ cile infection (adjusted incidence rate ratio for -ml increase per patient-bed-day . , % ci . - . , p< . ) and mrsa in the last four quarters of the study (adjusted incidence rate ratio for -ml increase per patient-bed-day . , % ci . - . , p< . ). the 'cleanyourhands campaign' was not independent of other national programmes to reduce analysis also identiÀ ed that the publication of the health act and the department of health improvement team visits were associated with reductions in mrsa and c.difÀ cile. in the hospital-wide study, the authors demonstrated a decrease in the cumulative incidence of hcai caused by mrsa (change in level, p= . ; change in trend, p= . ) and xdrab (change in level, p= . ; change in trend, p< . ) during the intervention period. hand hygiene compliance was signiÀ cantly correlated with increased consumption of abhr, and improved overall from . % in to . % in (p< . ). hand hygiene compliance was also signiÀ cantly correlated with professional categories of healthcare workers (p< . ) in both general wards and icus (p< . ). the controlled before-after study of a range of patient safety interventions in england, including hand hygiene, as measured by abhr and soap consumption in non-specialist acute hospitals, reported no signiÀ cant differences in the rate of increase in consumption of abhr (p= . favouring controls and p= . favouring intervention) and non-signiÀ cant decreases in c. difÀ cile (p= . ) and mrsa (p= . ). alcohol-based hand rub should be made available at the point of care in all healthcare facilities. hand hygiene resources and healthcare worker adherence to hand hygiene guidelines should be audited at regular intervals, and the results should be fed back to healthcare workers to improve and sustain high levels of compliance. healthcare organisations must provide regular training in risk assessment, effective hand hygiene and glove use for all healthcare workers. local programmes of education, social marketing, and audit and feedback should be refreshed regularly and promoted by senior managers and clinicians to maintain focus, engage staff and produce sustainable levels of compliance. patient involvement in multi-modal strategies to improve hand hygiene among healthcare workers is established, and includes making it acceptable for patients and carers to request that healthcare workers clean their hands. however, research suggests that many patients and carers do not feel empowered to challenge staff, particularly doctors. , , , many nhs trusts have promoted hand hygiene among visitors by placing abhr at the entrances to wards and patient rooms, but there is no evidence that this reduces hcai. despite being highlighted as an important gap in research, the role of patients' hands in the cross-transmission of microorganisms has not been investigated systematically, other than in ecologic studies that describe hand or skin contamination [ ] [ ] [ ] or observations of non-use of hand hygiene products. studies of effective interventions to enable patients to clean their hands remain small scale and descriptive in nature. [ ] [ ] [ ] [ ] we identiÀ ed three studies that described interventions to improve patient hand hygiene: one in an outbreak situation, one uncontrolled before-after study of parent education in a single paediatric icu, and one as part of a prospective observational study in a community hospital. none of these studies met the quality criteria for inclusion in this systematic review. [ ] [ ] [ ] however, all of these studies suggested that improving patient/carer hand hygiene had some effect on crosstransmission of microorganisms and hand hygiene technique. national guidelines indicate that it is important to educate patients and carers about the importance of hand hygiene, and inform them about the availability of hand hygiene facilities and their role in maintaining standards of healthcare workers' hand hygiene. patients and relatives should be provided with information about the need for hand hygiene and how to keep their own hands clean. patients should be offered the opportunity to clean their hands before meals; after using the toilet, commode or bedpan/urinal; and at other times as appropriate. products available should be tailored to patient needs and may include alcohol-based hand rub, hand wipes and access to handwash basins. total number of articles located = abstract indicates that the article: relates to infections associated with hand hygiene; is written in english; is primary research, a systematic review or a meta-analysis; and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text conÀ rms that the article: relates to infections associated with hand hygiene; is written in english; is primary research (randomised controlled trials, prospective cohort, interrupted time series, controlled before-after, quasi-experimental, experimental studies answering speciÀ c questions), a systematic review or a meta-analysis including the above designs; and informs one or more of the review questions. total number of studies selected for appraisal during sift = all articles that described primary research, a systematic review or a meta-analysis and met the sift criteria were independently critically appraised by two appraisers using sign and epoc criteria. consensus and grading was achieved through discussion. total number of studies accepted after critical appraisal = total number of studies rejected after critical appraisal = this section discusses the evidence and associated recommendations for the use of ppe by healthcare workers in acute care settings and includes the use of aprons, gowns, gloves, eye protection and face masks/respirators to prevent potential transmission of pathogenic microorganisms to staff, patients and the healthcare environment. the use of gloves for other purposes does not form part of these guidelines. where health and safety legislation underpins a recommendation, this is indicated by 'health & safety (h&s)' in addition to the classiÀ cation of any clinical evidence underpinning the recommendations. the primary roles of ppe are to protect staff and reduce opportunities for cross-transmission of microorganisms in hospitals. , , there is no evidence that uniforms or work clothing are associated with hcai. however, there is a public expectation that healthcare workers will wear work and protective clothing to minimise any potential risk to patients and themselves. , the decision to use or wear ppe must be based upon an assessment of the level of risk associated with a speciÀ c patient care activity or intervention, and take account of current health and safety legislation. [ ] [ ] [ ] [ ] there is evidence that both a lack of knowledge of guidelines and non-adherence to guideline recommendations are common, and that regular in-service education and training is required. , [ ] [ ] [ ] [ ] selection of personal protective equipment must be based on an assessment of the: • risk of transmission of microorganisms to the patient or carer; • risk of contamination of healthcare practitioners' clothing and skin by patients' blood or body Á uids; and • suitability of the equipment for proposed use. healthcare workers should be educated and their competence assessed in the: • assessment of risk; • selection and use of personal protective equipment; and • use of standard precautions. supplies of personal protective equipment should be made available wherever care is delivered and risk assessment indicates a requirement. the use of gloves as an element of ppe and contact precautions is an everyday part of clinical practice for healthcare workers. , , there are other indications unrelated to preventing the cross-transmission of infection that require gloves to be worn (e.g. the use of some chemicals or medications). the two main indications for the use of gloves in the prevention of hcai are: • to protect hands from contamination with organic matter and microorganisms; and • to reduce the risk of cross-transmission of microorganisms to staff and patients. gloves should be selected on the basis of a risk assessment, and should be suitable for the proposed task and the materials being handled. [ ] [ ] [ ] gloves are categorised as medical gloves (examination and surgical) and protective gloves. examination gloves are available as sterile or non-sterile for use by healthcare workers during clinical care to prevent contamination with microorganisms, blood and body Á uids. surgical gloves are available as sterile for use by healthcare workers during surgical and other invasive procedures. protective gloves are used to protect healthcare workers from chemical hazards. gloves should not be worn as a substitute for hand hygiene. their prolonged and unnecessary use may cause adverse reactions and skin sensitivity, and may lead to crosscontamination of the patient environment. , the need to wear gloves and the selection of appropriate glove materials requires careful assessment of the task to be performed and its related risks to patients and healthcare workers. , , , , risk assessment should include consideration of: • who is at risk (patient or healthcare worker) and whether sterile or non-sterile gloves are required; • potential for exposure to blood, body Á uids, secretions and excretions; • contact with non-intact skin or mucous membranes during care and invasive procedures; and • healthcare worker and patient sensitivity to glove materials. we identiÀ ed four observational studies which suggested that clinical gloves are not used in line with current guidance, and that glove use impacts negatively on hand hygiene. [ ] [ ] [ ] [ ] in addition, a cluster rct of screening and enhanced contact precautions for patients colonised with mrsa or vre found no reduction in transmission, but also found that adherence to contact precautions was less than ideal. gloves must be removed immediately following each care activity for which they have been worn, and hands must be decontaminated in order to prevent the cross-transmission of microorganisms to other susceptible sites in that individual or to other patients. gloves should not be washed or decontaminated with abhr as a substitute for changing gloves between care activities. there is evidence that hands become contaminated when clinical gloves are worn, even when the integrity of the glove appears undamaged. , , in terms of leakage, gloves made from natural rubber latex (nrl) perform better than vinyl gloves in laboratory test conditions. , standards for the manufacture of medical gloves for single use require gloves to perform to european standards. [ ] [ ] [ ] [ ] [ ] however, the integrity of gloves cannot be guaranteed, and hands may become contaminated during the removal of gloves. , , , the appropriate use of medical gloves provides barrier protection and reduces the risk of hand contamination from blood, body Á uids, secretions and excretions, but does not eliminate the risk. hands cannot be considered to be clean because gloves have been worn, and should be decontaminated following the removal of gloves. used gloves must be disposed of in accordance with the requirements of current legislation and local policy for waste management. gloves must be worn for: • invasive procedures; • contact with sterile sites and nonintact skin or mucous membranes; • all activities that have been assessed as carrying a risk of exposure to blood or body Á uids; and • when handling sharps or contaminated devices. gloves must be: • worn as single-use items; • put on immediately before an episode of patient contact or treatment; • removed as soon as the episode is completed; • changed between caring for different patients; and • disposed of into the appropriate waste stream in accordance with local policies for waste management. hands must be decontaminated immediately after gloves have been removed. clinical gloves should be used by healthcare workers to prevent the risk of hand contamination with blood, body Á uids, secretions and excretions, and to protect patients from potential cross-contamination of susceptible body sites or invasive devices. having decided that gloves should be used for a healthcare activity, the healthcare worker must make a choice between the use of: • sterile or non-sterile gloves, based on contact with susceptible sites or clinical devices; and • surgical or examination gloves, based on the aspect of care or treatment to be undertaken. healthcare organisations must provide gloves that conform to european standards (en - , - , - ), and which are acceptable to healthcare practitioners. [ ] [ ] [ ] medical gloves are available in a range of materials, the most common being nrl, which remains the material of choice due to its efÀ cacy in protecting against bloodborne viruses and properties that enable the wearer to maintain dexterity. , patient or healthcare practitioner sensitivity to nrl proteins must also be taken into account when deciding on glove materials. synthetic gloves are generally more expensive than nrl gloves and may not be suitable for all purposes. nitrile gloves have the same chemical range as nrl gloves and may also lead to sensitivity problems in healthcare workers and patients. polythene gloves are not suitable for clinical use due to their permeability and tendency to damage easily. a study that compared the performance of nitrile, latex, copolymer and vinyl gloves under stressed and unstressed conditions found that nitrile gloves had the lowest failure rate, suggesting that nitrile gloves are a suitable alternative to nrl gloves, provided that there are no sensitivity issues. importantly, the study noted variation in performance of the same type of glove produced by different manufacturers. the health and safety executive (hse) also provide a guide-to-glove selection for employers. a range of ce-marked medical and protective gloves that are acceptable to healthcare personnel and suitable for the task must be available in all clinical areas. sensitivity to natural rubber latex in patients, carers and healthcare workers must be documented, and alternatives to natural rubber latex gloves must be available. national and international guidelines recommend that ppe should be worn by all healthcare workers when close contact with the patient, materials or equipment may lead to contamination of uniforms or other clothing with microorganisms, or when there is a risk of contamination with blood or body Á uids. , , disposable plastic aprons are recommended for general clinical use. full-body gowns need only be used where there is the possibility of extensive splashing of blood or body Á uids, and should be Á uid repellent. , we identiÀ ed a systematic review of the evidence that microbial contaminants found on the work clothing of healthcare practitioners are a signiÀ cant factor in cases of hcai. the reviewers identiÀ ed seven small-scale studies that described the progressive contamination of work clothing during clinical care, and a further three studies that suggested a link with microbial contamination and infection. , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] one of the three studies was conducted in a simulated scenario and demonstrated that it was possible to transfer s. aureus from nurses' gowns to patients' bed sheets, but this was not associated with clinical infection. a further pair of linked studies, associated with an outbreak of bacillus cereus, showed an epidemiological link between contaminated clothing and hcai, but this occurred when surgical scrub suits became highly contaminated in an industrial laundry, rather than as a result of clinical care. , a further study demonstrated high levels of contamination of gowns, gloves and stethoscopes with vre following examination of patients known to be infected. a systematic review of eight studies that assessed the effects of gowning by attendants and visitors found no evidence to suggest that over-gowns are effective in reducing mortality, clinical infection or bacterial colonisation in infants admitted to newborn nurseries. one quasi-experimental study investigated the use of gowns and gloves as opposed to gloves alone for prevention of acquisition of vre in a medical icu setting. a further prospective observational study investigated the use of a similar intervention in a medical icu. these studies suggested that the use of gloves and gowns may minimise the transmission of vre when colonisation pressure is high. disposable plastic aprons must be worn when close contact with the patient, materials or equipment pose a risk that clothing may become contaminated with pathogenic microorganisms, blood or body Á uids. full-body Á uid-repellent gowns must be worn where there is a risk of extensive splashing of blood or body Á uids on to the skin or clothing of healthcare workers. plastic aprons/Á uid-repellent gowns should worn as single-use items for one procedure or episode of patient care, and disposed of into the appropriate waste stream in accordance with local policies for waste management. when used, non-disposable protective clothing should be sent for laundering. healthcare workers (and sometimes patients) may use standard, Á uid-repellent surgical face masks to prevent respiratory droplets from the mouth and nose being expelled into the environment. face masks are also used, often in conjunction with eye protection, to protect the mucous membranes of the wearer from exposure to blood and/or body Á uids when splashing may occur. our previous systematic reviews failed to reveal any robust experimental studies that demonstrated that healthcare workers wearing surgical face masks protected patients from hcai during routine ward procedures, such as wound dressing or invasive medical procedures. , face masks are also used to protect the wearer from inhaling aerosolised droplet nuclei expelled from the respiratory tract. as surgical face masks are not effective at À ltering out such particles, specialised respiratory protective equipment (respirators) may be recommended for the care of patients with certain respiratory diseases [e.g. active multiple drugresistant pulmonary tuberculosis, severe acute respiratory syndrome (sars) and pandemic inÁ uenza]. the À ltration efÀ ciency of these respirators will protect the wearer from inhaling small respiratory particles, but to be effective, they must À t closely to the face to minimise leakage around the mask. , , the selection of the most appropriate respiratory protective equipment (rpe) should be based on a suitable risk assessment that includes the task being undertaken, the characteristics of the biological agent to which there is a risk of exposure, as well as the duration of the task and the local environment. where the activity involves procedures likely to generate aerosols of biological agents transmitted by an airborne route (e.g. intubation), rpe with an assigned protection factor (apf) of (equivalent to ffp ) should be used. in other circumstances, such as where the agent is transmitted via droplet rather than aerosol or where the level of aerosol exposure is low, the risk assessment may conclude that other forms of rpe (e.g. apf / ffp ) or a physical barrier (e.g. surgical face mask) may be appropriate, such as when caring for patients with inÁ uenza. where rpe is required, it must À t the user properly and the user must be fully trained in how to wear and adjust it. we identiÀ ed four systematic reviews of the use of facial protection, all of which had been undertaken in the aftermath of the sars outbreak and in response to the h n inÁ uenza pandemic. a range of study designs were considered in each of the reviews, including cluster rcts, rcts, cohort studies and descriptive before-after studies. overall, many studies were poorly controlled, with no accounting for confounders, such as poor compliance in the weaker studies. the authors of each of the reviews concluded that there was no strong evidence that masks/respirators alone are effective for the prevention of respiratory viral infections. masks/respirators should be used together with other protective measures to reduce transmission. [ ] [ ] [ ] [ ] our previous systematic review indicated that different protective eyewear offered protection against physical splashing of infected substances into the eyes (although not on all occasions), but that compliance was poor. expert opinion recommends that face and eye protection reduce the risk of occupational exposure of healthcare workers to splashes of blood or body Á uids. , , , sp fluid-repellent surgical face masks and eye protection must be worn where there is a risk of blood or body Á uids splashing into the face and eyes. appropriate respiratory protective equipment should be selected according to a risk assessment that takes account of the infective microorganism, the anticipated activity and the duration of exposure. respiratory protective equipment must À t the user correctly and they must be trained in how to use and adjust it in accordance with health and safety regulations. personal protective equipment should be removed in the following sequence to minimise the risk of cross/self-contamination: • gloves; • apron; • eye protection (when worn); and • mask/respirator (when worn). hands must be decontaminated following the removal of personal protective equipment. total number of articles located = ag ( ), fp ( ) abstract indicates that the article: relates to infections associated with protective clothing; is written in english; is primary research, a systematic review or a meta-analysis; and appears to inform one or more of the review questions. total number of articles retrieved from sift = ag ( ), fp ( ) full text conÀ rms that the article: relates to infections associated with protective clothing; is written in english; is primary research (randomised controlled trials, prospective cohort, interrupted time series, controlled before-after, quasi-experimental), a systematic review or a meta-analysis including the above designs; and informs one or more of the review questions. total number of studies selected for appraisal during sift = ag ( ), fp ( ) all articles that described primary research, a systematic review or a meta-analysis and met the sift criteria were independently critically appraised by two appraisers using sign and epoc criteria. consensus and grading was achieved through discussion. total number of studies accepted after critical appraisal = ag ( ), fp ( ) total number of studies rejected after critical appraisal = ag ( ), fp ( ) this section discusses the evidence and associated recommendations for the safe use and disposal of sharps in general care settings. this includes minimising the potential infection risks associated with sharps use and disposal, and the use of needle protection devices. the use and disposal of sharps is subject to the health and safety at work act and several elements of health and safety legislation including: where health and safety legislation underpins a recommendation, this is indicated by 'h&s' in addition to the classiÀ cation of any clinical evidence underpinning the recommendations. the hse deÀ ne a sharp as a needle, blade or other medical instrument capable of cutting or piercing the skin. similarly, a sharps injury is an incident that causes a needle, blade or other medical instrument to penetrate the skin (percutaneous injury). the safe handling and disposal of needles and other sharp instruments forms part of an overall strategy of clinical waste disposal to protect staff, patients and visitors from exposure to bloodborne pathogens. the national audit ofÀ ce identiÀ ed that needlestick and sharps injuries ranked alongside moving and handling, falls, trips and exposure to hazardous substances as the main types of accidents experienced by nhs staff. a later royal college of nursing survey of nurses found that almost half ( %) had, at some point in their career, sustained a sharps injury from a device that had previously been used on a patient. a similar number ( %) reported fearing sharps injuries, and nearly half ( %) reported that they had not received training from their employer on safe needle use. the 'eye of the needle' report from the health protection agency conÀ rms that healthcare workers continue to be exposed to bloodborne virus infections, even though such exposures are largely preventable. the average risk of transmission of bloodborne viruses following a single percutaneous exposure from an infected person, in the absence of appropriate post-exposure prophylaxis, has been estimated to be: , , • hepatitis b virus, one in three; • hepatitis c virus, one in ; and • human immunodeÀ ciency virus, one in . national and international guidelines are consistent in their recommendations for the safe use and disposal of sharp instruments and needles, and the management of healthcare workers who are exposed to potential infection from bloodborne viruses. , [ ] [ ] [ ] as with many infection prevention and control policies, the assessment and management of the risks associated with the use of sharps is paramount, and safe systems of work and engineering controls must be in place to minimise any identiÀ ed risks. national and european union legislation requires the uk and all eu member states to provide protection for all healthcare workers exposed to the risk of sharps injuries. in summary, the health and safety (sharp instruments in healthcare) regulations require all employers, under existing health and safety law, to: • conduct risk assessments; • avoid unnecessary use of sharps and, where this is not possible, use safer sharps that incorporate protection mechanisms; • prevent the recapping of needles; • ensure safe disposal by placing secure sharps containers close to the point of use; • provide employees with adequate information and training on the safe use and disposal of sharps, what to do in the event of a sharps injury and the arrangements for testing, immunisation and post-exposure prophylaxis, where appropriate; • record and investigate sharps incidents; and • provide employees who have been injured with access to medical advice, and offer testing, immunisation, post-exposure prophylaxis and counselling, where appropriate. , legislation also includes a duty for employees who receive a sharps injury whilst undertaking their work to inform their employer as soon as is practicable. , all healthcare workers must be aware of their responsibility in avoiding sharps injuries. we identiÀ ed a systematic review which included studies that focused on education and training interventions to minimise the incidence of occupational injuries involving sharps devices. the authors identiÀ ed À ve primary beforeafter studies that demonstrated a consistent reduction in the incidence of percutaneous injuries when other safety initiatives (e.g. training) were implemented before and during the introduction of safer sharps devices. [ ] [ ] [ ] [ ] [ ] these studies used a range of interventions in one setting and are not generalisable. however, education is essential in ensuring that staff understand safe ways of working and how to use safer sharps devices. this should form a part of induction programmes for new staff and on-going in-service education. the introduction of new devices should include an appropriate training programme as part of staff introduction. sharps must not be passed directly from hand to hand, and handling should be kept to a minimum. needles must not be recapped, bent or disassembled after use. used sharps must be discarded at the point of use by the person generating the waste. all sharps containers must: • conform to current national and international standards; • be positioned safely, away from public areas and out of the reach of children, and at a height that enables safe disposal by all members of staff; • be secured to avoid spillage; • be temporarily closed when not in use; • not be À lled above the À ll line; and • be disposed of when the À ll line is reached. all clinical and non-clinical staff must be educated about the safe use and disposal of sharps and the action to be taken in the event of an injury. to improve patient and staff safety, legislation and the department of health require healthcare providers and their employees to pursue safer methods of working through risk assessment to eliminate the use of sharps and, where this is not possible, the use of safer sharps. , , the incidence of sharps injuries has led to the development of safety devices in many different product groups. they are designed to minimise the risk of operator injury during sharps use, as well as 'downstream' injuries that occur after disposal, often involving the housekeeping or portering staff responsible for the collection of sharps disposal units. the lack of well-designed, controlled intervention studies means that evidence to show whether or not safety devices are effective in reducing rates of infection is limited. however, a small number of studies have shown signiÀ cant reductions in injuries associated with the use of safety devices in cannulation, , phlebotomy - and injections. it is logical that where needle-free or other safety devices are used, there is a resulting reduction in sharps injuries. a review of needlestick injuries in scotland suggested that % of injuries would 'probably' or 'deÀ nitely' have been prevented if a safety device had been used. however, some studies have identiÀ ed a range of barriers to the expected reduction in injuries, including staff resistance to using new devices, complexity of device operation or improper use, and poor training. a comprehensive report and product review s conducted in the usa provides background information and guidance on the need for and use of needlestick-prevention devices, but also gives advice on establishing and evaluating a sharps injury prevention programme. it reported that all devices have limitations in relation to cost, applicability and/or effectiveness. some of the devices available are more expensive than standard devices, may not be compatible with existing equipment, and may be associated with an increase in bloodstream infection rates if used incorrectly. nice identiÀ ed three rcts that compared safety cannulae with standard cannulae. the studies were all in hospital settings and of low/very-low quality. the quality of evidence for safety needle devices was low, with no rcts identiÀ ed and the À ve before-after implementation studies being of very-low quality. the quality of evidence for training was similarly low, with the type of training varying across the À ve observational studies identiÀ ed. we identiÀ ed a systematic review undertaken by the hse which reviewed studies that provided evidence for reductions in the incidence of occupational sharps injuries associated with use of sharps safety devices, education and training, and the acceptability of sharps safety devices. thirteen studies, predominantly with observational designs, demonstrated that safer sharps devices were associated with a signiÀ cant reduction in the incidence of healthcare worker needlestick injury. , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] however, safety devices were not the total solution to reducing occupational injury. the beneÀ cial outcome of consulting with end-users of safer sharps devices before they are introduced was demonstrated in À ve studies identiÀ ed in this review. , , [ ] [ ] [ ] [ ] in the usa, the occupational safety health administration and the national institute for occupational safety and health suggest that a thorough evaluation of any device is essential before purchasing decisions are made. , similarly, the hse suggests that the end-users of any safer sharps device should be involved in the assessment of user acceptability and clinical applicability of any needle safety devices. the evaluation should ensure that the safety feature works effectively and reliably, that the device is acceptable to healthcare practitioners and that it does not have an adverse effect on patient care. use safer sharps devices where assessment indicates that they will provide safe systems of working for healthcare workers. organisations should involve end-users in evaluating safer sharps devices to determine their effectiveness, acceptability to practitioners, impact on patient care and cost beneÀ t prior to widespread introduction. systematic review questions total number of articles located = abstract indicates that the article: relates to infections associated with sharps; is written in english, is primary research, a systematic review or a meta-analysis; and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text conÀ rms that the article: relates to infections associated with sharps; is written in english; is primary research (randomised controlled trials, prospective cohort, interrupted time series, controlled before-after, quasi-experimental), a systematic review or a meta-analysis including the above designs; and informs one or more of the review questions. total number of studies selected for appraisal during sift = all articles that described primary research, a systematic review or a meta-analysis and met the sift criteria were independently critically appraised by two appraisers using sign and epoc criteria. consensus and grading was achieved through discussion. the term 'asepsis' means the absence of potentially pathogenic microorganisms. asepsis applies to both medical and surgical procedures. medical asepsis aims to minimise the risk of contamination by microorganisms, and prevent their transmission by applying standard principles of infection prevention, including decontaminating hands, use of ppe, maintaining an aseptic area, and not touching susceptible sites or the surface of invasive devices. surgical asepsis is a more complex process, including procedures to eliminate microorganisms from an area (thus creating an aseptic environment), and is practised in operating theatres and for invasive procedures, such as the insertion of a central venous catheter (cvc). 'aseptic technique' is a term applied to a set of specifi c practices and procedures used to assure asepsis and prevent the transfer of potentially pathogenic microorganisms to a susceptible site on the body (e.g. an open wound or insertion site for an invasive medical device) or to sterile equipment/devices. it involves ensuring that susceptible body sites and the sterile parts of devices in contact with a susceptible site are not contaminated during the procedure. the aseptic technique is an essential element of the prevention of hcai, particularly when the body's natural defence mechanisms are compromised. however, similar to nice, we identifi ed no clinical or economic evidence that any one approach to the aseptic technique is more clinically or cost-effective than another. thus, all recommendations here are class d/gpp. no studies that met the inclusion criteria and compared education interventions for improving the aseptic technique generally were identifi ed. we identifi ed one systematic review that assessed education interventions to improve competence in the aseptic insertion and maintenance of cvcs. the review included studies of educational interventions that were designed to change staff behaviour related to: general asepsis, maximal sterile barrier (msb) precautions during insertion, cutaneous antisepsis, and other aspects of insertion and maintenance practice. the studies all described multi-modal education approaches alone or combined with demonstration, simulation, video and self-study. only one of these studies reported improvements in competence with performing the aseptic technique as a discrete outcome, and nine studies measured overall compliance with the total insertion bundle. variations in terminology are used in the literature to describe the aseptic technique. inconsistencies in the use of terms and application of the principles of asepsis in clinical practice have been addressed in a framework referred to as 'aseptic non-touch technique'. this provides a practice structure and educational materials aimed at minimising variation and developing competence in practice. however, no comparative evidence indicating the effi cacy of this approach was identifi ed. organisations should provide education to ensure that healthcare workers are trained and competent in performing the aseptic technique. the aseptic technique should be used for any procedure that breaches the body's natural defences, including the: • insertion and maintenance of invasive devices; • infusion of sterile fl uids and medication; and • care of wounds and surgical incisions. abstract indicates that the article: relates to infections associated with asepsis; is written in english; is primary research, a systematic review or a meta-analysis; and appears to inform one or more of the review questions. full text conÀ rms that the article: relates to infections associated with asepsis; is written in english; is primary research (randomised controlled trialsrct), prospective cohort, interrupted time series, controlled before-after, quasi-experimental), a systematic review or a meta-analysis including the above designs; and informs one or more of the review questions. total number of studies selected for appraisal during sift = all articles that described primary research, a systematic review or a meta-analysis and met the sift criteria were independently critically appraised by two appraisers using sign and epoc criteria. consensus and grading was achieved through discussion. total number of studies accepted after critical appraisal = total number of studies rejected after critical appraisal = this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. evidence identiÀ ed in the healthcare infection control practices advisory committee (hicpac) systematic review was used to support the recommendations in these guidelines. some recommendations from the previous guidelines have been revised to improve clarity; where a new recommendation has been made, this is indicated in the text. these recommendations are not detailed procedural protocols, and need to be incorporated into local guidelines. none are regarded as optional. these guidelines apply to adults and children aged year who require a short-term indwelling urethral catheter ( days), and should be read in conjunction with the guidance on standard principles. the recommendations are divided into six distinct interventions: • assessing the need for catheterisation; • selection of catheter type and system; • catheter insertion; • catheter maintenance; • education of patients, relatives and healthcare workers; and • system interventions for reducing the risk of infection. urinary tract infection (uti) is the most common infection acquired as a result of health care, accounting for % of hcai, with between % and % of utis associated with a urethral catheter. , catheters predispose to infection because microorganisms are able to bypass natural host mechanisms, such as the urethra and micturition, and gain entry to the bladder. most microorganisms causing catheterassociated uti (cauti) gain access to the urinary tract either extraluminally or intraluminally. extraluminal contamination may occur as the catheter is inserted, by contamination of the catheter from healthcare workers' hands or from the patient's own perineal Á ora. extraluminal contamination is also thought to occur from microorganisms ascending from the perineum. intraluminal contamination occurs by reÁ ux of microorganisms from a contaminated urine drainage bag. the bladder is normally sterile; in the non-catheterised patient, a uti is usually identiÀ ed from the symptoms of dysuria and frequency of urination. patients who develop a uti with a short-term indwelling urethral catheter in place may not experience these symptoms, and diagnosis may be based on other signs, such as fever or suprapubic or loin tenderness. after a few days of catheterisation, microorganisms may be isolated from urine and, in the absence of any symptoms of uti, this is called 'bacteriuria'. the duration of catheterisation is the dominant risk factor for cauti, and virtually all catheterised patients develop bacteriuria within month. for the purpose of these guidelines, a duration of catheterisation of days is considered to be a short-term catheterisation. several factors contribute to the potential development of cauti, including the formation of bioÀ lms and encrustation of the catheter. bacteria on the catheter surface and drainage bag multiply rapidly, adhering to the surface by excreting extracellular polysaccharides and forming a layer known as a 'bioÀ lm'. bacteria within the bioÀ lm are morphologically and physiologically different from free-living planktonic bacteria in the urine, and have considerable survival advantages as they are protected from the action of antibiotic therapy. whilst bioÀ lms commonly form on devices inserted into the body, they can cause additional problems on urethral catheters if the bacteria produce the enzyme urease, such as proteus mirabilis. this enzyme causes the urine to become alkaline, inducing crystallisation of calcium and magnesium phosphate within the urine. these crystals are incorporated into the bioÀ lm and, over time, result in encrustation of the catheter. encrustation is generally associated with long-term catheterisation, as it has a direct relationship with the length of catheterisation. urinary catheterisation is a frequent intervention during clinical care in hospital, affecting a signiÀ cant number of patients. it has been estimated that - % of hospitalised patients have a urinary catheter inserted during their stay. [ ] [ ] [ ] [ ] this number is much higher in icus. the risk of infection is associated with the method and duration of catheterisation, the quality of catheter care and patient susceptibility. bacteriuria develops in approximately % of catheterised patients after - days, and % ( % ci - %) of these will develop symptoms of cauti. approximately . % ( % ci . - . %) of those with cauti develop life-threatening secondary infections, such as bacteraemia or sepsis, where mortality rates range from % to %. , cauti is associated with prolonged hospitalisation, re-admission and increased mortality. patients at particular risk are those who are immunocompromised, the elderly and patients with diabetes. physical and psychological discomfort associated with insertion, removal and the catheter in situ are common. complications such as inÁ ammation, urethral strictures, mechanical trauma, bladder calculi and other infections of the renal system also occur. , [ ] [ ] [ ] urine retention after catheter removal is also a frequent occurrence. in some instances, especially in older people, cauti may contribute to falls and delirium. the treatment of both cauti and other infection sequelae contribute to the emerging problem of antibiotic resistance in hospitals, and uropathogens are a major source of infections caused by antimicrobial-resistant organisms. cauti also increases the cost of health care due to delayed discharge from hospital, antimicrobial treatment and staff resources. the À nancial burden of cauti on the nhs has been estimated as £ million per year, with an estimated cost per episode of £ . , however, there are no robust economic assessments of the cost of cauti. there is a strong association between the duration of catheterisation and the risk of infection (i.e. the longer the catheter is in place, the higher the incidence of uti). , , in acute care facilities, the risk of developing bacteriuria increases % for each day of catheterisation. approximately % of bacteriuric patients will develop cauti, and of these, up to % develop a severe secondary infection such as bloodstream infection. current best practice emphasises the importance of documenting all procedures involving the catheter or drainage system in the patient's records, and providing patients with adequate information in relation to the need for catheterisation, details of the insertion, catheter and drainage system, maintenance procedures and plan for removal of the catheter. , there is some evidence to suggest that computer management systems improve documentation and are associated with reduced duration of catheterisation. using a short-term indwelling urethral catheter only when necessary after considering alternatives and ensuring the catheter is removed as soon as possible are simple and effective methods to prevent cauti. the use of a short-term indwelling urethral catheter may be appropriate in patients with acute urinary retention or obstruction, those who require precise urine output measures to monitor an underlying condition, and patients undergoing certain surgical procedures (especially urological procedures and those of prolonged duration). a short-term indwelling urethral catheter may also be appropriate to minimise discomfort or distress (e.g. during end-of-life care or in the management of open sacral or perineal wounds when the patient is incontinent). however, short-term indwelling urethral catheterisation should not be used as a method of managing urinary incontinence. while the use of a short-term indwelling urethral catheter is sometimes unavoidable, there is evidence that catheters are inserted without a clear clinical indication, clinicians are not always aware they are in situ, and they are not removed promptly when no longer required. , interventions that prompt or facilitate the removal of unnecessary catheters may, therefore, reduce the risk of cauti. these interventions have been categorised as reminder systems which prompt clinicians that the catheter is in place and removal should be considered, or stop orders, which indicate that catheters should be removed after a set period of time or when deÀ ned clinical criteria have been met. , [ ] [ ] [ ] a systematic review of studies (one rct, one nrct, three controlled before-after studies and nine uncontrolled beforeafter studies) on reminder and stop order systems found that these interventions signiÀ cantly decreased the rate of cauti and did not increase the need for re-catheterisation, although, as some of the studies were not controlled, they were susceptible to bias in favour of the intervention. a second systematic review identiÀ ed a number of uncontrolled before-after studies that used ultrasound bladder scanners to assess for urinary retention and support appropriate catheterisation. when used in combination with guidelines, insertion checklist/kit, education, audit and feedback, and reminder/stop orders, ultrasound bladder scanners were found to decrease the use of urethral catheters by - %. only use a short-term indwelling urethral catheter in patients for whom it is clinically indicated, following assessment of alternative methods and discussion with the patient. uc document the clinical indication(s) for catheterisation, date of insertion, expected duration, type of catheter and drainage system, and planned date of removal. assess and record the reasons for catheterisation every day. remove the catheter when no longer clinically indicated. evidence from best practice indicates that the incidence of cauti in patients catheterised for a short time (up to week) is not inÁ uenced by any particular type of catheter material. , however, many practitioners have strong preferences for one type of catheter over another. this preference is often based on clinical experience, patient assessment and materials that induce the least allergic response. smaller gauge catheters with a -ml balloon minimise urethral trauma, mucosal irritation and residual urine in the bladder; all factors that predispose to cauti. , there is also a risk of urethral trauma associated with using a female length catheter in a male patient, and systems should be in place to ensure that this does not occur. however, in adults that have recently undergone urological surgery, larger gauge catheters may be indicated to allow for the passage of blood clots. our previous evidence-based guidelines identiÀ ed three experimental studies that compared the use of latex with silicone catheters, which found no signiÀ cant difference in the incidence of bacteriuria. , , we identiÀ ed one new systematic review which included three trials that compared different types of standard (nonantiseptic-/non-antimicrobial-impregnated) catheters. these studies did not provide sufÀ cient evidence to suggest that one type of catheter may be more effective than another for the prevention of bacteriuria. [ ] [ ] [ ] [ ] in our previous systematic review, we found evidence related to the efÀ cacy of using short-term indwelling urethral catheters coated or impregnated with antiseptic or antimicrobial agents from four systematic reviews and one meta-analysis. in general, all of these À ve studies suggested that antiseptic-impregnated or antimicrobial-coated shortterm indwelling urethral catheters can signiÀ cantly prevent or delay the onset of cauti compared with standard untreated urinary catheters. , [ ] [ ] [ ] [ ] the consensus in these À ve reviews of evidence, however, is that the individual studies reviewed are generally of poor quality; for instance, in one case, only eight studies out of met the inclusion criteria, and in another, of the six reports describing seven trials included, only one scored À ve in the quality assessment. the other À ve reports only scored one. the studies included in these reviews investigated a wide range of coated or impregnated catheters, including catheters coated or impregnated with: silver alloy, , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] silver oxide, gendine, gentamicin, silverhydrogel, - minocycline, rifampicin, chlorhexidinesilver-sulfadiazine, chlorhexideine-sulfadiazine-triclosan, nitrofurazone and nitrofuroxone. four studies compared the use of silver-coated (silver alloy or silver oxide) catheters with silicone, hydrogel or teÁ on ® latex. - a systematic review and meta-analysis of these and other studies found that silver-alloy-coated (but not silver-oxide-coated) catheters were associated with a lower incidence of bacteriuria. , despite their unit cost, these devices may provide a costeffective option if overall numbers of infections are reduced signiÀ cantly through their use. however, the few studies that have explored the cost-beneÀ t/cost-effectiveness of using these devices have been inconclusive. , , , we identiÀ ed two new systematic reviews of the efÀ cacy of silver-coated or antimicrobial-impregnated catheters for the prevention of cauti. , the À rst systematic review included rcts, as well as one nrct, and concluded that silver-coated (alloy or oxide) short-term indwelling urethral catheters reduced the risk of bacteriuria but did not demonstrate an effect on cauti. catheters impregnated with antimicrobial agents (minocycline, rifampicin or nitrofurazone) were found to reduce the rate of bacteriuria during the À rst week of catheterisation, but not for catheter durations exceeding week. although antimicrobial-impregnated catheters reduced the risk of cauti, the number of cases was too small to demonstrate a signiÀ cant effect. the second systematic review, which included nine rcts and three quasi-experimental studies, concluded that, compared with standard catheters, both nitrofurazone-impregnated and silver-alloy-coated catheters can prevent and delay the onset of bacteriuria during short-term use. however, there were no data on the risk of cauti. we identiÀ ed one multi-centre rct that compared silveralloy-coated and nitrofurazone-impregnated catheters with standard teÁ on-coated latex for short-term catheterisation. although the nitrofurazone-impregnated and silver-alloycoated catheters were associated with a reduced risk of cauti compared with the teÁ on-coated latex, the effect was not considered to be clinically effective (adjusted or . , % ci . - . and adjusted or . , % ci . - . , respectively). the nitrofurazone-impregnated catheter, but not the silver-alloy-coated catheter, was associated with a signiÀ cantly lower incidence of bacteriuria (or . , % ci . - . , p= . ). however, the nitrofurazone-impregnated catheter was associated with increased discomfort during the period the catheter was in place. a major limitation of this study was that the median duration of catheterisation was s h. p. loveday et al. / journal of hospital infection s ( ) s -s days (range - days) and the risk of cauti associated with this short period is correspondingly low. also, utis developing up to weeks post randomisation were included in the outcome measurement, even though they may not have been directly associated with catheterisation. the economic analysis suggested that nitrofurazone-impregnated catheters, but not silver-alloy-coated catheters, may be cost-effective, but the measures of cost were associated with a large amount of uncertainty. overall, the evidence suggests that silver-coated urethral catheters reduce the risk of bacteriuria, but there is insufÀ cient evidence to indicate whether they reduce the risk of cauti in short-term catheterised patients. assess patient's needs prior to catheterisation in terms of: • latex allergy; • length of catheter (standard, female, paediatric); • type of sterile drainage bag and sampling port (urometer, -l bag, leg bag) or catheter valve; and • comfort and dignity. select a catheter that minimises urethral trauma, irritation and patient discomfort, and is appropriate for the anticipated duration of catheterisation. uc select the smallest gauge catheter that will allow urinary outÁ ow and use a -ml retention balloon in adults (follow manufacturer's instructions for paediatric catheters). urological patients may require larger gauge sizes and balloons. in our previous review, we found evidence from one systematic review which suggested that the use of the aseptic technique has not demonstrated a reduction in the rate of cauti. however, principles of good practice, clinical guidance , and expert opinion, , , [ ] [ ] [ ] [ ] [ ] together with À ndings from another systematic review, agree that shortterm indwelling urethral catheters must be inserted using sterile equipment and the aseptic technique. expert opinion indicates that there is no advantage in using antiseptic preparations for cleansing the urethral meatus prior to catheter insertion. , , , whilst there is low-quality evidence to suggest that pre-lubrication of the catheter decreases the risk of bacteriuria, it is also important to use lubricant or anaesthetic gel in order to minimise urethral trauma and discomfort. there is no evidence suggesting a general beneÀ t of securing the catheter in terms of preventing the risk of cauti, but it is important in order to minimise patient discomfort. ensuring healthcare practitioners are trained and competent in the insertion of short-term indwelling urethral catheters will minimise trauma, discomfort and the potential for cauti. , , , neither we nor hicpac identiÀ ed any additional evidence of acceptable quality whilst updating our systematic review. catheterisation is an aseptic procedure and should only be undertaken by healthcare workers trained and competent in this procedure. uc clean the urethral meatus with sterile, normal saline prior to the insertion of the catheter. uc use lubricant from a sterile singleuse container to minimise urethral discomfort, trauma and the risk of infection. ensure the catheter is secured comfortably. maintaining a sterile, continuously closed urinary drainage system is central to the prevention of cauti. , , , , , the risk of infection reduces from % with an open system to - % when a sterile closed system is employed. , , breaches in the closed system, such as unnecessary emptying, changing of the urinary drainage bag or taking a urine sample, will increase the risk of cauti and therefore should be avoided. , , hands must be decontaminated, and clean and non-sterile gloves should be worn before manipulation of the catheter or the closed system, including drainage taps. a systematic review has suggested that sealed (e.g. taped, pre-sealed) drainage systems contribute to preventing bacteriuria. however, there is limited evidence regarding how often catheter bags should be changed. one study showed that higher rates of symptomatic and asymptomatic cauti were associated with a -day urinary drainage bag change regimen compared with no routine change regimen. best practice suggests that drainage bags should only be changed when necessary (i.e. according either to the manufacturer's recommendations or the patient's clinical need). , reÁ ux of urine is associated with infection and, consequently, drainage bags should be positioned in a way that ensures the free Á ow of urine and prevents back-Á ow. , it is also recommended that urinary drainage bags should be hung on an appropriate stand that prevents contact with the Á oor. a number of studies have investigated the addition of disinfectants and antimicrobials to drainage bags as a way of preventing cauti. three acceptable studies - from our original systematic review demonstrated no reduction in the incidence of bacteriuria following the addition of hydrogen peroxide or chlorhexidine to urinary drainage bags. these À ndings are supported by a further systematic review, which suggested that adding bacterial solutions to drainage bags had no effect on catheter-associated infection. neither we nor hicpac identiÀ ed any additional evidence of acceptable quality whilst updating our systematic review. uc connect a short-term indwelling urethral catheter to a sterile closed urinary drainage system with a sampling port. uc do not break the connection between the catheter and the urinary drainage system unless clinically indicated. uc change short-term indwelling urethral catheters and/or drainage bags when clinically indicated and in line with the manufacturer's recommendations. uc decontaminate hands and wear a new pair of clean non-sterile gloves before manipulating each patient's catheter. decontaminate hands immediately following the removal of gloves. uc use the sampling port and the aseptic technique to obtain a catheter sample of urine. uc position the urinary drainage bag below the level of the bladder on a stand that prevents contact with the Á oor. uc do not allow the urinary drainage bag to À ll beyond three-quarters full. uc use a separate, clean container for each patient and avoid contact between the urinary drainage tap and the container when emptying the drainage bag. uc do not add antiseptic or antimicrobial solutions to urinary drainage bags. our previous systematic reviews , found eight acceptable studies that compared meatal cleansing with a variety of antiseptic/antimicrobial agents or soap and water. no reduction in bacteriuria was demonstrated when using any of these preparations for meatal/peri-urethral hygiene compared with routine bathing or showering. , [ ] [ ] [ ] [ ] [ ] [ ] [ ] expert opinion and other systematic reviews support the view that active meatal cleansing is not necessary and may increase the risk of infection. , , , , , daily routine bathing or showering is all that is needed in order to maintain patient comfort. neither we nor hicpac identiÀ ed any additional evidence of acceptable quality whilst updating our systematic review. uc routine daily personal hygiene is all that is required for meatal cleansing. evidence from our previous systematic review did not demonstrate any beneÀ cial effect of bladder irrigation, instillation or washout with a variety of antiseptic or antimicrobial agents for the prevention of cauti. , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] evidence from best practice supports these À ndings of no beneÀ cial effect, and indicates that the introduction of such bladder maintenance solutions may have local toxic effects and contribute to the development of resistant microorganisms. however, continuous or intermittent bladder irrigation may be required for other urological or catheter management indications. given the frequency of urinary catheterisation in hospital patients and the associated risk of uti, it is important that patients, their relatives and healthcare workers responsible for catheter insertion and management are educated about infection prevention. all those involved must be aware of the signs and symptoms of uti and how to access expert help when difÀ culties arise. healthcare professionals must be conÀ dent and proÀ cient in associated procedures. we identiÀ ed two systematic reviews that reported evidence of the efÀ cacy of healthcare workers' education in reducing the risk of cauti within other system interventions. , most of the studies included in these reviews provided lowgrade evidence from uncontrolled before-after studies where a combination of different system interventions focusing on reducing the use of urethral catheters and risk of cauti were introduced. the À rst systematic review identiÀ ed one small controlled before-after study of an educational intervention with guideline change and posters that was associated with a reduction in use of urethral catheters [relative risk (rr) . , % ci . - . ]. another systematic review included one controlled before-after study that demonstrated a signiÀ cant (p< . ) increase in adherence to a clinical guideline on the insertion and maintenance of urethral catheters in association with an education programme. , a further study reported a reduction in cauti and an increase in adherence to protocols for hand hygiene and catheter care in association with an education programme. however, this study did not include a control group. uc healthcare workers should be trained and competent in the appropriate use, selection, insertion, maintenance and removal of short-term indwelling urethral catheters. uc ensure patients, relatives and carers are given information regarding the reason for the catheter and the plan for review and removal. if discharged with a catheter, the patient should be given written information and shown how to: • manage the catheter and drainage system; • minimise the risk of urinary tract infection; and • obtain additional supplies suitable for individual needs. a number of studies have reported the effect of quality improvement programmes on the risk of cauti. the components of these programmes include various combinations of clinical guidelines for catheter insertion and maintenance, education, audit and feedback of compliance with policy, physician/nurse reminder systems (to prompt removal if no longer necessary), automated or nurse-driven removal protocols [where the catheter is removed after a speciÀ ed period (e.g. - h) unless countermanded by the physician] and the use of bladder scanners to assess urinary retention and support appropriate catheterisation. we identiÀ ed three systematic reviews relevant to this question. , , the À rst was a review of interventions to remind physicians/nurses to remove unnecessary catheters and the outcome on cauti, short-term indwelling urethral catheter use and catheter replacement. it included studies (one rct, one nrct, three controlled before-after studies and nine uncontrolled before-after studies). interventions included prewritten or computer-generated stop orders, nurse-generated daily bedside reminders to remove catheters, and daily use of a checklist or protocol to review need for the catheter. some studies also implemented catheter placement restrictions and education. the meta-analysis suggested that the use of reminder or stop order systems reduced the rate of cauti by % (p< . ) and the mean duration of catheterisation by %, with . fewer days of catheterisation in the intervention group compared with the control group, and no difference in re-catheterisation rates. the second systematic review was a review of interventions to minimise the placement of urethral catheters in acute care patients. it included one rct, one nrct and six uncontrolled before-after studies. interventions included various combinations of clinician reminders, stop orders and indication checklists, use of bladder scanners and education. the authors concluded that the studies were too small and heterogeneous to draw a deÀ nitive conclusion about efÀ cacy in terms of reducing inappropriate catheter placement. the third systematic review included three controlled before-after studies and seven uncontrolled before-after studies measuring interventions that increased adherence to catheter care protocols or reduced unnecessary catheter use. interventions included reminders, stop orders, use of bladder scanners, education and catheterisation protocols with audit and feedback on performance. physician/nurse reminders, particularly automatic stop orders, were found to reduce the duration of catheterisation, although there were insufÀ cient data to determine their effect on cauti. many studies in this area are uncontrolled before-after designs and therefore susceptible to bias in favour of the intervention. however, these interventions constitute best practice, and this evidence supports the use of systems to minimise the insertion of catheters and promote timely removal to reduce both the duration of catheterisation and the risk of cauti. s uc use quality improvement systems to support the appropriate use and management of short-term urethral catheters and ensure their timely removal. these may include: • protocols for catheter insertion; • use of bladder ultrasound scanners to assess and manage urinary retention; • reminders to review the continuing use or prompt the removal of catheters; • audit and feedback of compliance with practice guidelines; and • continuing professional education. uc no patient should be discharged or transferred with a short-term indwelling urethral catheter without a plan documenting the: • reason for the catheter; • clinical indications for continuing catheterisation; and • date for removal or review by an appropriate clinician overseeing their care. systematic review questions . what are the clinical indications for the use of short-term urinary catheters?(*b) . what is the risk associated with short-term catheterisation in terms of bacteriuria, cauti, other morbidities and mortality? (b) . what is the effectiveness (in terms of patient acceptability and reduced risk of bacteriuria, cauti, other morbidities and mortality) and the cost-effectiveness of different types of short-term indwelling urinary catheters (material, coatings and design)? . what is the most effective catheter insertion technique in terms of patient acceptability and minimisation of urethral trauma, bacteriuria, cauti and other morbidities? . what is the most effective and cost-effective means of maintaining meatal hygiene and a closed drainage system? . what is the effectiveness of system interventions in reducing the use and duration of short-term urinary catheterisation to minimise the risk of bacteriuria, cauti, other morbidities and mortality? . what is the effectiveness of system interventions in improving healthcare workers' knowledge and behaviour relating to the insertion, maintenance and timely removal of indwelling urinary catheters to minimise the risk of bacteriuria, cauti, other morbidities and mortality? total number of articles located = abstract indicates that the article: relates to infections associated with short-term indwelling urethral catheters; is written in english; is primary research, a systematic review or a meta-analysis; and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text conÀ rms that the article: relates to infections associated with short-term indwelling urethral catheters; is written in english; is primary research (randomised controlled trials, prospective cohort, interrupted time series, controlled before-after, quasiexperimental), a systematic review or a meta-analysis including the above designs; and informs one or more of the review questions. total number of studies selected for appraisal during sift = all articles that described primary research, a systematic review or a meta-analysis and met the sift criteria were independently critically appraised by two appraisers using sign and epoc criteria. consensus and grading was achieved through discussion. this guidance is based on the best critically appraised evidence currently available. the type and class of supporting evidence explicitly linked to each recommendation is described. evidence identiÀ ed in the hicpac systematic review was used to support the recommendations in these guidelines. some recommendations from the previous guidelines have been revised to improve clarity; where a new recommendation has been made, this is indicated in the text. these recommendations are not detailed procedural protocols, and need to be incorporated into local guidelines. none are regarded as optional. intravascular access devices, including peripheral, central venous and arterial catheters, are commonly used in the management of patients in acute and chronic care settings. cvcs are frequently used during clinical care and include peripherally inserted, non-tunnelled and tunnelled, and totally implantable cvcs (table ) . the use of any of these catheters can result in bloodstream infection. catheter-related bloodstream infections (cr-bsi) associated with the insertion and maintenance of cvcs are potentially among the most dangerous complications associated with health care. , , in the most recent national prevalence survey, the health protection agency reported that the prevalence of bsi was . %, accounting for . % of the hcai detected; % of bsi occurred in patients with a vascular access device. a previous point prevalence survey reported that the prevalence of bsi was . %, accounting for % of the hcai detected; of these, % were primary cr-bsi. peripheral venous catheters (pvcs) cause phlebitis in some patients, with studies indicating mean rates of - %, [ ] [ ] [ ] [ ] but evidence suggests that these devices are less frequently associated with cr-bsi. , [ ] [ ] [ ] [ ] [ ] cr-bsi involves the presence of systemic infection and evidence implicating the intravascular catheter as its source (i.e. the isolation of the same microorganism from blood cultures as that shown to be signiÀ cantly colonising the intravascular catheter). , catheter colonisation refers to the growth of microorganisms on either the endoluminal or the external catheter surface beneath the skin in the absence of systemic infection. , the microorganisms that colonise catheter hubs and the skin adjacent to the insertion site are the source of most cr-bsi. coagulase-negative staphylococci, particularly staphylococcus epidermidis, are the microorganisms most frequently implicated in cr-bsi. other microorganisms commonly involved include s. aureus, candida species and enterococci. [ ] [ ] [ ] cr-bsi is generally caused either by skin microorganisms at the insertion site, which contaminate the catheter during insertion and migrate along the cutaneous catheter track after insertion, [ ] [ ] [ ] or microorganisms from the hands of healthcare workers that contaminate and colonise the catheter hub during care interventions. less commonly, infusate contamination or seeding from a different site of infection in the body via the bloodstream is identiÀ ed as a cause of cr-bsi. , these guidelines are based upon evidence-based guidelines for preventing intravascular device (ivd)-related infections, developed at the us centers for disease control and prevention by hicpac and published in . the agree ii collaboration appraisal instrument was used by four appraisers to review the guidelines independently. the appraisal process resulted in the decision that the guideline development processes were valid and that the guidelines were evidence based, categorised to the strength of the evidence examined, reÁ ective of current concepts of best practice. the guideline development advisory group considered that they were the most authoritative reference guidelines currently available. following the agree process, we systematically searched, retrieved and appraised additional evidence published since the search period identiÀ ed in the hicpac technical report. our search period for additional evidence spanned from to . these guidelines apply to caring for all adults and children over the age of year in nhs acute care settings with a cvc or pvc that is being used for the administration of Á uids, medications, blood components and/or parenteral nutrition. they should be used in conjunction with the recommendations for standard principles for preventing hcai, previously described in these guidelines. these recommendations describe general principles of best practice that apply to all patients in hospital in whom an intravascular catheter is being used during an acute episode of treatment/care. they do not speciÀ cally address the more detailed, technical aspects of the care of infants under year of age, or those children or adults receiving haemodialysis or chemotherapy who will generally have long-term intravascular catheters managed in renal dialysis or outpatient settings. the recommendations are divided into nine distinct interventions: • education of healthcare workers and patients; • general asepsis; • selection of type of intravascular catheter; • selection of intravascular catheter insertion site; • msb precautions during insertion; • cutaneous antisepsis; • catheter and catheter site care; • replacement strategies; and • general principles for catheter management. to improve patient outcomes and reduce healthcare costs, it is essential that everyone involved in caring for patients with intravascular catheters is educated about infection prevention. healthcare workers in hospitals need to be conÀ dent and proÀ cient in infection prevention practices, and to be aware of the signs and symptoms of clinical infection. structured educational programmes that enable healthcare workers to provide, monitor and evaluate care and continually increase their competence are critical to the success of any strategy designed to reduce the risk of infection. evidence reviewed by hicpac demonstrates that the risk of infection declines following standardisation of the aseptic technique, [ ] [ ] [ ] [ ] [ ] [ ] [ ] and increases when the maintenance of intravascular catheters is undertaken by inexperienced healthcare workers. , h. p. loveday et al. / journal of hospital infection s ( ) s -s we identiÀ ed two recent systematic reviews that assessed the effectiveness of education interventions in reducing cr-bsi. , the À rst concluded that current evidence comes predominantly from uncontrolled before-after studies that do not convincingly distinguish intervention effectiveness from secular trends. clinical practices are addressed by a wide variety of educational strategies that do not draw upon pedagogic, theoretical or conceptual frameworks and consequently do not provide generalisable conclusions about the most effective approaches to education to improve practice. the second systematic review concluded À rst that educational interventions appear to have the most prolonged and profound effect when used in conjunction with audit and feedback, and when availability of clinical equipment is consistent with the content of the education provided. second, that educational interventions will have a greater impact if baseline compliance with best practice is low. third, that repeated educational sessions, fed into daily practice, using practical participation, appear to have a small, additional effect on practice change compared with education alone. healthcare workers should be aware of the manufacturers' advice relating to the compatibility of individual devices with antiseptic solutions, dwell time and connections to ensure safe use. with intravascular catheters should be trained and assessed as competent in using and consistently adhering to practices for the prevention of catheter-related bloodstream infection. ivad healthcare workers should be aware of the manufacturer's advice relating to individual catheters, connection and administration set dwell time and compatibility with antiseptics and other Á uids to ensure the safe use of devices. ivad before discharge from hospital, patients with intravascular catheters and their carers should be taught any techniques they may need to use to prevent infection and manage their device. hand decontamination and meticulous attention to the aseptic technique are essential during catheter insertion, manipulation, changing catheter site dressings and for accessing the system. hands should be decontaminated using abhr or liquid soap and water when hands are visibly soiled or potentially contaminated with organic material, such as blood and other body Á uids. , the aseptic technique should be used for the insertion and management of ivds. structured education should be provided to ensure that healthcare workers are trained and assessed as competent in performing the aseptic technique. gloves should be worn for procedures involving contact with blood or body Á uids. sterile gloves must be worn for the insertion and dressing of cvcs. ivad hands must be decontaminated, with an alcohol-based hand rub or by washing with liquid soap and water if soiled or potentially contaminated with blood or body Á uids, before and after any contact with the intravascular catheter or insertion site. ivad use the aseptic technique for the insertion and care of an intravascular access device and when administering intravenous medication. the selection of the most appropriate intravascular catheter for each individual patient can reduce the risk of subsequent catheter-related infection. intravascular catheter material may be an important determinant in the development of catheter-related infection. polytetraÁ uroethylene (teÁ on) and polyurethane catheters have been associated with fewer infections than catheters made of polyvinyl chloride or polyethylene. [ ] [ ] [ ] multi-lumen intravascular access devices may be used because they permit the concurrent administration of Á uids and medications, parenteral nutrition and haemodynamic monitoring among critically ill patients. several rcts and other studies suggest that multi-lumen catheters are associated with a higher risk of infection than single-lumen catheters. , [ ] [ ] [ ] [ ] [ ] [ ] however, other studies examined by hicpac failed to demonstrate a difference in the rates of cr-bsi. , multi-lumen catheter insertion sites may be particularly prone to infection because of increased trauma at the insertion site or because multiple ports increase the frequency of cvc manipulation. , patients with multi-lumen catheters tend to be more severely ill, although the increased risk of cr-bsi appears to be independent of underlying illness. a prospective epidemiological study in patients receiving parenteral nutrition concluded that either using a singlelumen catheter or a dedicated port in a multi-lumen catheter for parenteral nutrition would reduce the risk of cr-bsi. neither we nor hicpac identiÀ ed any additional evidence for this recommendation whilst updating our systematic review, and hicpac considered this to be a unresolved issue. in a systematic review and quantitative meta-analysis focused on determining the risk of cr-bsi and catheter colonisation in multi-lumen catheters compared with single-lumen catheters, the reviewers reported that, although cr-bsi was more common in patients with multi-lumen catheters, when conÀ ned to highquality studies that control for patient differences, there is no signiÀ cant difference in rates of cr-bsi for the two types of catheter. this analysis suggests that multi-lumen catheters are not a signiÀ cant risk factor for increased cr-bsi or local catheter colonisation compared with single-lumen cvcs. a later systematic review and quantitative meta-analysis tested whether single-vs multi-lumen cvcs had an impact on catheter colonisation and cr-bsi. the study authors concluded that there is some evidence from À ve rcts with data on cvcs that for every single-lumen catheters inserted, one cr-bsi (which would have occurred had multi-lumen catheters been used) would be avoided. neither we nor hicpac identiÀ ed any additional evidence of acceptable quality whilst updating our systematic reviews. ivad use a catheter with the minimum number of ports or lumens essential for management of the patient. ivad preferably use a designated singlelumen catheter to administer lipidcontaining parenteral nutrition or other lipid-based solutions. surgically implanted (tunnelled) devices (e.g. hickman ® catheters) are commonly used to provide vascular access to patients requiring long-term intravenous therapy. alternatively, totally implantable intravascular access devices (e.g. port-a-cath ® ) are also tunnelled under the skin, but have a subcutaneous port or reservoir with a self-sealing septum that is accessible by needle puncture through intact skin. multiple studies comparing the incidence of infection associated with long-term tunnelled cvcs and/or totally implantable ivds with that from percutaneously (non-tunnelled) inserted catheters have been assessed by hicpac. although most studies reported a lower rate of infection in patients with tunnelled cvcs, [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] some studies found no signiÀ cant difference in the rate of infection between tunnelled and nontunnelled catheters. , additionally, most studies concluded that totally implantable devices had the lowest reported rates of cr-bsi compared with either tunnelled or non-tunnelled cvcs. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] however, although these devices are less disruptive for patients in terms of daily living, they have a number of disadvantages including the need for needle insertion resulting in increased discomfort. additional evidence was obtained from studies of efÀ cacy of tunnelling to reduce catheter-related infections in patients with short-term cvcs. one rct demonstrated that subcutaneous tunnelling of short-term cvcs inserted into the internal jugular vein reduced the risk for cr-bsi. in a later rct, the same investigators failed to show a statistically signiÀ cant difference in the risk for cr-bsi for subcutaneously tunnelled femoral vein catheters. an additional meta-analysis of rcts was focused on the efÀ cacy of tunnelling short-term cvcs to prevent catheterrelated infections. data synthesis demonstrated that tunnelling decreased catheter colonisation by % and decreased cr-bsi by % in comparison with non-tunnelled placement. the majority of the beneÀ t in the decreased rate of catheter sepsis came from one trial of cvcs inserted at the internal jugular site. the reduction in risk was not signiÀ cant when pooled with data from À ve subclavian catheter trials. tunnelling was not associated with increased risk of mechanical complications from placement or technical difÀ culties during placement. this meta-analysis concluded that tunnelling decreased catheterrelated infections; however, a synthesis of the evidence in this meta-analysis does not support routine subcutaneous tunnelling of short-term subclavian venous catheters, and this cannot be recommended unless efÀ cacy is evaluated at different placement sites and relative to other interventions. peripherally inserted central catheters (piccs) are increasingly used for medium term ( weeks to months) intravascular access, particularly in adults and children requiring antimicrobial treatment, chemotherapy and parenteral nutrition. evidence examined by hicpac suggested that piccs are associated with a lower rate of infection than that associated with other non-tunnelled cvcs. , retrospective studies in outpatient settings indicate that rates of picc-related bloodstream infection range from . to . per catheter-days. [ ] [ ] [ ] [ ] [ ] [ ] however, there is little recent robust evidence regarding comparison of rates of cr-bsi in piccs vs other long-term central venous access devices. a prospective study that compared the use of inpatient piccs indicated a similar rate of cr-bsi to non-tunnelled catheters placed in the internal jugular or subclavian veins and a higher rate than cuffed and tunnelled (ct) catheters (picc . cr-bsi per catheter-days vs nontunnelled . cr-bsi per catheter-days vs cuffed and tunnelled . cr-bsi per catheter-days). a systematic review of studies indicated that when used in inpatients, piccs pose a slightly lower risk of cr-bsi than standard noncuffed and non-medicated cvcs placed in the subclavian or internal jugular vein ( . cr-bsi per catheter-days vs . cr-bsi per catheter-days). neither we nor hicpac identiÀ ed any additional evidence of acceptable quality whilst updating our systematic review. ivad use a tunnelled or implanted central venous access device with a subcutaneous port for patients in whom long-term vascular access is required. ivad use a peripherally inserted central catheter for patients in whom mediumterm intermittent access is required. some catheters and cuffs are marketed as anti-infective and are coated or impregnated with antimicrobial or antiseptic agents, e.g. chlorhexidine/silver sulfadiazine, minocycline/ rifampicin, platinum/silver, and ionic silver in subcutaneous collagen cuffs attached to cvc. evidence reviewed by hicpac [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] indicated that the use of antimicrobial or antisepticimpregnated cvc in adults whose catheter is expected to remain in place for more than À ve days could decrease the risk for cr-bsi. this may be cost-effective in high-risk patients (intensive care, burn and neutropenic patients) and in other patient populations in whom the rate of cr-bsi exceeds . per , catheter days even when there is a comprehensive strategy to reduce rates of cr-bsi. a meta-analysis of rcts published between - included data on , catheters ( , anti-infective and , control). eleven of the trials in this meta-analysis were conducted in intensive care unit (icu) settings; four among oncology patients, two among surgical patients; two among patients receiving total parenteral nutrition (tpn) and four among other patient populations. study authors concluded that antibiotic and chlorhexidine-silver sulfadiazine coatings are anti-infective for short (approximately one week) insertion time. for longer insertion times, there was no data on antibiotic coating, and there is evidence of lack of effect for À rst generation chlorhexidine-silver sulfadiazine coating. for silver-impregnated collagen cuffs, there is evidence of lack of effect for both short-and long-term insertion. second generation chlorhexidine/silver sulfadiazine catheters with chlorhexidine coating on both the internal and external luminal surfaces are now available. the external surface of these catheters have three times the amount of chlorhexidine and extended release of the surface bound antiseptics than that in the À rst generation catheters (which are coated with chlorhexidine/silver sulfadiazine only on the external luminal surface). early studies indicated that the prolonged anti-infective activity associated with the second generation catheters improved efÀ cacy in preventing infections. a systematic review and economic evaluation in concluded that rates of cr-bsi were statistically signiÀ cantly reduced when an antimicrobial cvc was used. studies in this review report the best effect when catheters were treated with minocycline/rifampin, or internally and externally treated with silver or chlorhexidine/silver sulfadiazine. a trend to statistical signiÀ cance was seen in catheters only extraluminally coated. investigation of other antibiotic treated catheters is limited to single studies with non-signiÀ cant results. we identiÀ ed two additional systematic reviews and one rct in our updated search. a recent cochrane review of studies using impregnation, coating or bonding for reducing central venous catheter-related infections in adults included , predominantly unblinded studies, with low or unclear risk of bias. patients with impregnated catheters had lower rates of cr-bsi (actual risk reduction of % ( % ci, % to %)), and catheter colonisation (actual risk reduction % ( % ci, % to %)). in terms of catheter colonisation sub-group analysis showed that impregnated catheters were more beneÀ cial in studies conducted in intensive care units (rr . ( % ci, . to . )) than in studies conducted in haemo-oncology (rr . ( % ci, . to . )) or in patients requiring long-term parenteral nutrition rr . ( % ci, . to . )). however, sub-group analysis did not identify the same beneÀ t in terms of cr-bsi. there were no statistically signiÀ cant differences in the overall rates of bloodstream infections or mortality, although these outcomes were less often assessed than cr-bsi and catheter colonisation. a collaborative network metaanalysis of cvc use in adults indicated that rifampicin-based impregnated cvc was the only type of impregnated/coated cvc that reduced catheter colonisation and cr-bsi compared with standard cvc. in a single blind non-inferiority trial, authors concluded that cvc coated with -Á uorouracil were non-inferior to chlorhexidine and silver sulfadiazine coated cvcs with respect to the incidence of catheter colonisation ( . % vs. . %, respectively). chlorhexidine is a potential allergenic antiseptic that is present in many products and is widely used in health care for skin antisepsis, insertion of urinary catheters or coating cvcs. in susceptible individuals, initial contact will cause a minor hypersensitivity reaction that, although not severe, should not go undocumented as subsequent exposures to chlorhexidine may lead to anaphylaxis. , the medicines and healthcare products regulatory agency has alerted all healthcare providers in the uk to the risk of chlorhexidine allergy and requires them to have systems in place that ensure: • awareness of the potential for an anaphylactic reaction to chlorhexidine; • known allergies are recorded in patient notes; • labels and instructions for use are checked to establish if products contain chlorhexidine prior to use on patients with a known allergy; • if a patient experiences an unexplained reaction, checks are carried out to identify whether chlorhexidine was used or was impregnated in a medical device that was used; and • reporting of allergic reactions to products containing chlorhexidine to the medicines and healthcare products regulatory agency. ivad use an antimicrobial-impregnated central venous access device for adult patients whose central venous catheter is expected to remain in place for > days if catheter-related bloodstream infection rates remain above the locally agreed benchmark, despite the implementation of a comprehensive strategy to reduce catheter-related bloodstream infection. the site at which a vascular access catheter is placed can inÁ uence the subsequent risk of cr-bsi because of variation in both the density of local skin Á ora and the risk of thrombophlebitis. cvcs are generally inserted in the subclavian, jugular or femoral veins, or peripherally inserted into the superior vena cava by way of the major veins of the upper arm (i.e. the cephalic and basilar veins of the antecubital space). pvcs are normally inserted in the upper extremity, although alternatives, such as the foot and scalp, may be used in children and babies. hicpac examined a number of studies that compared insertion sites and concluded that cvcs inserted into subclavian veins had a lower risk for catheter-related infection than those inserted into either jugular or femoral veins. , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] guideline developers suggested that internal jugular insertion sites may pose a greater risk for infection because of their proximity to oropharyngeal secretions and because cvcs at this site are difÀ cult to immobilise. however, mechanical complications associated with catheterisation might be less common with internal jugular than with subclavian vein insertion. femoral catheters have been demonstrated to have relatively high colonisation rates compared with subclavian and internal jugular sites when used in adults, and current guidelines suggest that the femoral site should be avoided because it is associated with both a higher risk of deep vein thrombosis and catheter-related infection than internal jugular or subclavian catheters. , [ ] [ ] [ ] [ ] [ ] [ ] one study also found that the risk of infection associated with catheters placed in the femoral vein is accentuated in obese patients. thus, in adult patients, a subclavian site is preferred for preventing infection, although other factors (e.g. the potential for mechanical complications, risk for subclavian vein stenosis and catheter-operator skill) should be considered when deciding where to place the catheter. we identiÀ ed a systematic review and meta-analysis in which investigators reviewed two rcts, eight cohort studies and data from a national hcai programme. these provided evidence that the selection of device insertion site is not a signiÀ cant factor for the prevention of cr-bsi. the metaanalysis demonstrated no difference in the risk of cr-bsi between the femoral, subclavian and internal jugular sites, s having removed two studies that were statistical outliers. the authors concluded that a pragmatic approach to site selection for central venous access, taking into account underlying disease (e.g. renal disease), the expertise and skill of the operator and the risks associated with placement, should be used. two meta-analyses , indicate that the use of real-time two-dimensional ultrasound for the placement of cvcs substantially reduced mechanical complications compared with the standard landmark placement technique. consequently, the use of ultrasound may indirectly reduce the risk of infection by facilitating mechanically uncomplicated subclavian placement. in the uk, nice guidelines provide recommendations for two-dimensional ultrasound placement of cvcs. piccs may be used as an alternative to subclavian or jugular vein catheterisation. these are inserted into the superior vena cava via the major veins of the upper arm above the antecubital fossa. hicpac indicated that they are less expensive, associated with fewer mechanical complications (e.g. haemothorax, inÀ ltration and phlebitis) and easier to maintain than short peripheral venous catheters. in a prospective cohort study using data from two randomised trials and a systematic review to estimate rates of picc-related bloodstream infection in hospitalised patients, the author concluded that piccs used in high-risk hospitalised patients are associated with a rate of cr-bsi similar to conventional cvcs placed in the internal jugular or subclavian veins (two to À ve per catheter-days). to reduce the risk of cr-bsi and phlebitis, it is preferable to use an upper extremity site for inserting a pvc in adults and to replace a device inserted in a lower extremity to a site in the upper extremity as soon as possible. in paediatric patients, the upper or lower extremity and the scalp (in young infants) can be used for siting a pvc. , ivad in selecting an appropriate intravascular insertion site, assess the risks for infection against the risks of mechanical complications and patient comfort. ivad use the upper extremity for nontunnelled catheter placement unless medically contraindicated. the importance of strict adherence to hand decontamination and the aseptic technique as the cornerstone for preventing catheter-related infection is widely accepted. although this is considered adequate for preventing infections associated with the insertion of short peripheral venous catheters, it is recognised that central venous catheterisation carries a signiÀ cantly greater risk of infection. studies examined by hicpac concluded that if msb precautions were used consistently during cvc insertion, catheter contamination and subsequent catheter-related infections could be reduced signiÀ cantly. , , , a prospective randomised trial that tested the efÀ cacy of msb precautions to reduce infections associated with long-term, non-tunnelled subclavian silicone catheters, compared with routine procedures, found that they decreased the risk of cr-bsi signiÀ cantly. msb precautions involve wearing sterile gloves and gown, cap and mask, and using a full-body sterile drape during insertion of the catheter. it has been generally assumed that cvcs inserted in the operating theatre pose a lower risk of infection than those inserted on inpatient wards or other patient care areas. however, data examined by hicpac from two prospective studies suggest that the difference in risk of infection depended largely on the magnitude of barrier protection used during catheter insertion, rather than the surrounding environment (i.e. ward vs operating theatre). , a systematic review of the value of msb precautions to prevent cr-bsi deÀ ned the components as: the person inserting the catheter should wear a head cap, face mask, sterile body gown and sterile gloves, and use a full-size sterile drape. their search identiÀ ed papers discussing the prevention of cr-bsi. the majority of these were narrative reviews or consensus statements. three primary research studies, differing in design, patient population and clinical settings, that compared infection outcomes using msb precautions with less stringent barrier techniques, concluded that the use of msb precautions resulted in a reduction in catheter-related infections. the authors concluded that using msb precautions appears to decrease transmission of microorganisms, delay colonisation and reduce the rate of hcai. they also suggested that biological plausibility and the available evidence support using msb precautions during routine insertion of a cvc to minimise the risk of infection. they recommended that, given the lack of adverse patient reactions, the relatively low cost of msb precautions and the high cost of cr-bsi, it is probable that msb precautions will prove to be a cost-effective, or even a cost-saving, intervention. neither we nor hicpac identiÀ ed any additional evidence of acceptable quality whilst updating our systematic review. ivad use maximal sterile barrier precautions for the insertion of central venous access devices. microorganisms that colonise catheter hubs and the skin surrounding the vascular catheter insertion site are the cause of most cr-bsi. , as the risk of infection increases with the density of microorganisms around the insertion site, skin cleansing/antisepsis of the insertion site is one of the most important measures for preventing catheter-related infections. since the early s, research has focused on identifying the most effective antiseptic agent for skin preparation prior to the insertion of ivds in order to prevent catheter-related infections, especially cr-bsi. in the uk, clinicians principally use alcohol, or either povidone iodine (pvi) or chg, in various strengths, and the latter two as either aqueous or alcohol-based solutions. a prospective randomised trial of agents used for cutaneous antisepsis demonstrated that % aqueous chg was superior to either % pvi or % alcohol for the prevention of central venous and arterial catheter-related infections. a further prospective, randomised trial demonstrated that a % alcoholbased solution of . % chg and . % benzalkonium chloride was more effective for the prevention of central venous or arterial catheter colonisation and infection than % pvi. the use of % pvi solution in % ethanol has been shown to be associated with a substantial reduction in catheter-related colonisation and infection compared with % aqueous pvi. clinicians may À nd this useful for those patients for whom alcoholic chg is contraindicated. a meta-analysis of studies that compared the risk for cr-bsi following insertion-site skin care with any type of chg solution vs pvi solution indicated that the use of chg rather than pvi can reduce the risk for cr-bsi by approximately % (rr . , % ci . - . ) in hospitalised patients who require short-term catheterisation (i.e. for every catheter sites disinfected with chg rather than pvi, episodes of catheter colonisation and episodes of cr-bsi would be prevented). in this analysis, several types of chg solution were used in the individual trials, including . % or % chg alcohol solution and . % or % chg aqueous solution. all of these solutions provided a concentration of chg that is higher than the minimal inhibitory concentration (mic) for most nosocomial bacteria and yeasts. subset analysis of aqueous and non-aqueous solutions showed similar effect sizes, but only the subset analysis of the À ve studies that used alcoholic chg solution produced a signiÀ cant reduction in cr-bsi. as few studies used chg aqueous solution, the lack of a signiÀ cant difference seen for this solution compared with pvi solution may be a result of inadequate statistical power. additionally, an economic decision analysis based on available evidence from the same authors suggested that the use of chg, rather than pvi, for skin care would result in a . % decrease in the incidence of cr-bsi, a . % decrease in mortality, and À nancial savings per catheter used. several studies were examined that focused on the application of antimicrobial ointments to the catheter site at the time of catheter insertion, or during routine dressing changes, to reduce microbial contamination of catheter insertion sites. reported efÀ cacy of this practice for the prevention of catheter-related infections yielded contradictory À ndings. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] there was also concern that the use of polyantibiotic ointments that were not fungicidal could signiÀ cantly increase the rate of colonisation of the catheter by candida species. , nice identiÀ ed three rcts that compared the effectiveness of different antiseptic solutions for the insertion of pvcs in hospitalised patients. the evidence from these studies was considered to be of very low quality, and no conclusion could be drawn about the beneÀ ts of one particular antiseptic solution over another. however, while there is no evidence comparing different concentrations of chg, the reviewers indicated that the trend in the evidence suggests that chg in alcohol may be more effective than pvi in alcohol. we identiÀ ed one recent systematic review of the clinical efÀ cacy and perceived role of chg in skin antisepsis that included studies about intravascular access. the authors suggested a potential source of bias, as many studies have overlooked the importance of alcohol when assessing the efÀ cacy of chg. the authors assessed the attribution of chg in each study as correct, incorrect or intermediate. studies were scored and analysis was performed separately to assess chg efÀ ciency. the authors concluded that chg is more efÀ cient than pvi or any other technique alone, but that the presence of alcohol provides additional beneÀ t. the authors suggested that vascular catheters require the immediate antiseptic activity provided by alcohol prior to insertion. they also require a long-lasting antiseptic, as they stay in place for prolonged periods of time. ivad decontaminate the skin at the insertion site with a single-use application of % chlorhexidine gluconate in % isopropyl alcohol (or povidone iodine in alcohol for patients with sensitivity to chlorhexidine) and allow to dry prior to the insertion of a central venous access device. ivad decontaminate the skin at the insertion site with a single-use application of % chlorhexidine gluconate in % isopropyl alcohol (or povidone iodine in alcohol for patients with sensitivity to chlorhexidine) and allow to dry before inserting a peripheral vascular access device. ivad do not apply antimicrobial ointment routinely to the catheter placement site prior to insertion to prevent catheter-related bloodstream infection. the safe maintenance of an intravascular catheter and appropriate care of the insertion site are essential components of a comprehensive strategy for preventing catheter-related infections. this includes good practice in caring for the patient's catheter hub and connection port, the use of an appropriate intravascular catheter site dressing regimen, and using Á ush solutions to maintain the patency of the catheter. following placement of a pvc or cvc, a dressing is used to protect the insertion site. as occlusive dressings trap moisture on the skin and provide an ideal environment for the rapid growth of local microÁ ora, dressings for insertion sites must be permeable to water vapour. the two most common types of dressings used for insertion sites are sterile, transparent, semi-permeable polyurethane dressings coated with a layer of an acrylic adhesive ('transparent dressings') and gauze and tape dressings. transparent dressings are permeable to water vapour and oxygen, and impermeable to microorganisms. hicpac reviewed the evidence related to which type of dressing provided the greatest protection against infection, including the largest controlled trial of dressing regimens on pvcs, a meta-analysis comparing the risk of cr-bsi using transparent vs gauze dressings and a cochrane review. all concluded that the choice of dressing can be a matter of preference, but if blood is leaking from the catheter insertion site, a gauze dressing might be preferred to absorb the Á uid. we identiÀ ed an updated cochrane review which concluded that bloodstream infection was higher in the transparent polyurethane group compared with the gauze and tape group. the included trials were graded low quality due to the small sample size and risk of bias. there was additional low-quality evidence that demonstrated no difference between highly permeable polyurethane dressings and other polyurethane dressings in the prevention of cr-bsi. hicpac reviewed the evidence related to impregnated sponge dressings compared with standard dressings and found two rcts in adults which demonstrated that chlorhexidineimpregnated sponge dressings were associated with a signiÀ cant reduction in cr-bsi. however, a meta-analysis that included eight rcts found a reduction in exit site colonisation but no signiÀ cant reduction in cr-bsi. in paediatric patients, two small rcts found a reduction in catheter colonisation but not cr-bsi, and evidence of localised contact dermatitis when used for infants of very low birth weight. we identiÀ ed one systematic review and meta-analysis, undertaken as part of a quality improvement collaborative, that synthesised the effects of the routine use of chgimpregnated sponge dressings in reducing centrally inserted cr-bsi. five studies were included in the analysis; two of the À ve studies were in patients in haemo/oncological icus, and the remaining three studies were in surgical and medical icus. four of the À ve studies were sponsored by the manufacturer of the product. the reviewers concluded that chg-impregnated sponge dressings are effective for the prevention of cr-bsi (or . , % ci . - . ) and catheter colonisation (or . , % ci . - . ). we identiÀ ed an economic evaluation of the use of chg sponge dressings and the non-inferiority of dressing changes at and days. the authors concluded that the major cost avoided by the use of chg sponge dressings and -day dressing changes rather than -day dressing changes was the increased length of stay of days associated with cr-bsi. chlorhexidineimpregnated sponge dressings remained cost saving for any value where the cost per cr-bsi was >$ and the baseline rate of cr-bsi was > . %. we identiÀ ed a further rct of chg dressings compared with highly adhesive semi-permeable dressings or standard semi-permeable dressings for the prevention of cr-bsi in patients. in the chg group, the major catheterrelated infection rate was % lower ( . vs . per catheter-days, hr . , % ci . - . , p= . ) and the cr-bsi rate was % lower ( . vs . per catheterdays, hr . , % cl . - . , p= . ) than with nonchlorhexidine dressings. decreases were also noted in catheter colonisation and skin colonisation rates at catheter removal. highly adhesive dressings decreased the detachment rate to . % vs . % (p< . ) and the number of dressings per catheter to two (one to four) vs three (one to À ve) (p< . ), but increased skin colonisation (p< . ) and catheter colonisation (hr . , % cl . - . , p= . ) without inÁ uencing cr-bsi rates. hicpac identiÀ ed three studies that investigated the efÀ cacy of a % chg-impregnated washcloth in reducing the risk of cr-bsi. these studies were included in a subsequent systematic review and meta-analysis on the efÀ cacy of either % chg-impregnated cloths or % chg solution for daily skin cleansing in adult acute care settings, mostly icus. twelve studies were included: one rct, one cluster nrct and controlled interrupted time series. five studies that reported the insertion technique included the use of chg. there was a high level of clinical heterogeneity and moderate statistical heterogeneity, which remained following a subgroup analysis by type of chg formulation. the authors concluded that among icu patients, daily chg bathing with chg liquid (or . , % ci . - . ) or cloths (or . , % ci . - . ) reduces the risk of cr-bsi. similar beneÀ t is obtained regardless of whether chg cloths or liquid preparation is used (or . , % ci . - . ). this review was not generalisable to paediatric care. whenever chg is used for insertion site dressings or skin cleansing, systems should be in place to ensure that it is not used for patients with a history of chlorhexidine sensitivity. a single rct compared the efÀ cacy of two commercially available alcohol-based antiseptic solutions for preparation and care of cvc insertion sites, with and without octenidine dihydrochloride. data were collected from to and published in . the authors concluded that octenidine in alcoholic solution is a better option than alcohol alone for the prevention of cvc-associated infections, and may be as effective as chg in practice but a comparative trial is needed. ivad use a sterile, transparent, semipermeable polyurethane dressing to cover the intravascular insertion site. ivad transparent, semi-permeable polyurethane dressings should be changed every days, or sooner, if they are no longer intact or if moisture collects under the dressing. ivad use a sterile gauze dressing if a patient has profuse perspiration or if the insertion site is bleeding or leaking, and change when inspection of the insertion site is necessary or when the dressing becomes damp, loosened or soiled. replace with a transparent semi-permeable dressing as soon as possible. ivad consider the use of a chlorhexidineimpregnated sponge dressing in adult patients with a central venous catheter as a strategy to reduce catheterrelated bloodstream infection. ivad consider the use of daily cleansing with chlorhexidine daily in adult patients with a central venous catheter as a strategy to reduce catheter-related bloodstream infection. ivad dressings used on tunnelled or implanted catheter insertion sites should be replaced every days until the insertion site has healed unless there is an indication to change them sooner. a dressing may no longer be required once the insertion site is healed. research previously described in these guidelines has described the superior effectiveness of chg to minimise the density of microorganisms around vascular catheter insertion sites. , , consequently, alcoholic chg is now widely used in the uk for disinfecting the insertion site during dressing changes. studies focused on the use of antimicrobial ointment applied under the dressing to the catheter insertion site to prevent catheter-related infection do not clearly demonstrate efÀ cacy. , most modern intravascular catheters and other catheter materials are not damaged by contact with alcohol. however, alcohol, and other organic solvents and oil-based ointments and creams, may damage some types of polyurethane and silicon catheter tubing (e.g. some catheters used in haemodialysis). the manufacturer's recommendations to only use disinfectants that are compatible with speciÀ c catheter materials must therefore be followed. ivad use a single-use application of % chlorhexidine gluconate in % isopropyl alcohol (or povidone iodine in alcohol for patients with sensitivity to chlorhexidine) to clean the central catheter insertion site during dressing changes, and allow to air dry. ivad use a single-use application of % chlorhexidine gluconate in % isopropyl alcohol (or povidone iodine in alcohol for patients with sensitivity to chlorhexidine) to clean the peripheral venous catheter insertion site during dressing changes, and allow to air dry. ivad do not apply antimicrobial ointment to catheter insertion sites as part of routine catheter site care. evidence indicates that the routine replacement of cvcs at scheduled time intervals does not reduce rates of cr-bsi. three randomised trials investigated strategies for replacing cvcs routinely at either days , or days compared with changing catheters when clinically indicated. two studies were conducted in adult icus , and a third study was undertaken in a renal dialysis unit. no difference in cr-bsi was observed in patients in the scheduled replacement groups compared with those replaced when clinically indicated. another suggested strategy for the prevention of cr-bsi is the routine scheduling of guidewire exchange of cvcs. a systematic review and meta-analysis of rcts concluded that when compared with insertion at a new site, guidewire exchange was associated with a trend towards increased rates of catheter colonisation (rr . , % ci . - . ), regardless of suspected cr-bsi at the time of replacement. guidewire exchange was also associated with a trend towards increased rates of catheter exitsite infection (rr . , % ci . - . ) and cr-bsi (rr . , % ci . - . ), but also associated with fewer mechanical complications relative to insertion at a new site. neither we nor hicpac identiÀ ed any additional evidence for these recommendations whilst updating our systematic review. we identiÀ ed one rct that compared a routine -day re-siting of pvcs compared with a clinically indicated resiting. ivd-related complication rates were per ivddays (clinically indicated) and per ivd-days (routine replacement) (p= . , hazard ratio . , % ci . - . ). re-siting a device on clinical indication would allow one in two patients to have a single cannula per course of intravenous treatment, as opposed to one in À ve patients managed with routine re-siting; overall complication rates appear similar. clinically indicated re-siting would achieve savings in equipment, staff time and patient discomfort. a recent update of a cochrane review found no evidence to support changing catheters every - h. evidence demonstrating that contamination of the catheter hub contributes to intraluminal microbial colonisation of catheters, particularly long-term catheters, was considered by hicpac. , [ ] [ ] [ ] [ ] [ ] [ ] catheter hubs are accessed more frequently when catheterisation is prolonged, and this increases the risk of cr-bsi originating from a colonised catheter hub rather than the insertion site. evidence from a prospective cohort study suggested that frequent catheter hub manipulation increases the risk for microbial contamination. additional studies concurred and recommended that hubs and sampling ports should be disinfected using either povidone iodine or chlorhexidine before they are accessed. , , a randomised prospective clinical trial investigated the use of needleless connectors or standard caps attached to cvc luer connections. results suggested that the use of needleless connectors may reduce the microbial contamination rate of cvc luers compared with standard caps. furthermore, disinfection of needleless connectors with either chlorhexidine/alcohol or pvi signiÀ cantly reduced external microbial contamination. both these strategies may reduce the risk of catheter-related infections acquired via the intraluminal route. we found no rct evidence comparing the efÀ cacy of different methods for the decontamination of ports and hubs prior to access. expert opinion, based on consensus and evidence extrapolated from experimental studies of hub decontamination, , , and studies of skin decontamination prior to insertion and during dressing changes, suggests that injection ports or catheter hubs should be decontaminated for a minimum of s using chg in % alcohol before and after accessing the system. although most intravascular catheters and catheter hub materials are now chemically compatible with alcohol or iodine, some may be incompatible and therefore the manufacturer's recommendations should be followed. ivad a single-use application of % chlorhexidine gluconate in % isopropyl alcohol (or povidone iodine in alcohol for patients with sensitivity to chlorhexidine) should be used to decontaminate the access port or catheter hub. the hub should be cleaned for a minimum of s and allowed to dry before accessing the system. the procedure of Á ushing and then leaving the lumen of a cvc À lled with an antibiotic solution is termed 'antibiotic lock prophylaxis' and has been described as a measure to prevent cr-bsi in haemodialysis or a patient who has a history of multiple cr-bsi despite optimal maximal adherence to the aseptic technique. evidence reviewed by hicpac demonstrated the effectiveness of this type of prophylaxis. however, the majority of the studies were conducted in haemodialysis patients and therefore may not be generalisable. we identiÀ ed a systematic review of rcts which concluded that the scientiÀ c evidence for the effectiveness of the routine use of antibiotic-based lock solutions is weak, thus supporting the hicpac evidence. in addition, there is concern that the use of such solutions could lead to an increase in antimicrobialresistant microorganisms. an additional placebo-rct of daily ethanol locks to prevent cr-bsi in patients with tunnelled catheters found that the reduction in the incidence of endoluminal cr-bsi using preventive ethanol locks was non-signiÀ cant, although the low incidence of endoluminal cr-bsi precludes deÀ nite conclusions, and the low incidence of cr-bsi in the placebo arm meant the study was underpowered in retrospect. signiÀ cantly more patients treated with ethanol locks discontinued their prophylactic treatment due to non-severe, ethanol-related adverse effects. ivad antimicrobial lock solutions should not be used routinely to prevent catheterrelated bloodstream infections. hicpac identiÀ ed no studies which demonstrated that oral or parenteral antibacterial or antifungal drugs reduced the incidence of cr-bsi among adults. however, among lowbirthweight infants, two studies on vancomycin prophylaxis demonstrated a reduction in cr-bsi but no reduction in mortality. as the prophylactic use of vancomycin is an independent risk factor for the acquisition of vre, it is likely that the risk of acquiring vre outweighs the beneÀ t of using prophylactic vancomycin. , topical mupirocin is used to suppress s. aureus in nasal carriers. some studies have shown that mupirocin applied nasally (or locally to the insertion site) results in reduced risk of cr-bsi. however, rates of mupriocin resistance of % have been reported in the uk, and its incompatibility with polyurethane catheters means that it should not be used routinely. long-term tunnelled cvcs are frequently used for patients with cancer who require intravenous treatments. a cochrane review published in concluded that prophylactic antibiotics or catheter Á ushing with vancomycin and heparin may be of beneÀ t in reducing the risk of catheter-related infections in these high-risk cancer patients. however, this practice should not be used routinely in order to minimise the development of antimicrobial resistance. ivad do not routinely administer intranasal or systemic antimicrobials before insertion or during the use of an intravascular device to prevent catheter colonisation or bloodstream infection. the placement of any cvc or pulmonary artery catheter leads to thrombus formation shortly after insertion, providing a focus for bacterial growth. catheters manufactured from silicone or polyethylene and placed in the subclavian vein are less frequently associated with thrombus formation. between % and % of patients with long-term cvcs and piccs develop a thrombosis of the large vessels, and patients are treated with prophylactic heparin to prevent the formation of both deep vein thrombosis and catheter thrombus. , [ ] [ ] [ ] [ ] [ ] [ ] the use of anticoagulants heparin may be administered through several different routes. an early meta-analysis of rcts compared the effectiveness of heparin administration via an infusion, subcutaneously or intermittent Á ush for the prevention of thrombus formation and cr-bsi in patients with short-term cvcs. prophylactic heparin infusion was associated with a decrease in catheter thrombus formation, deep vein thrombosis, catheter colonisation and a trend towards reductions in cr-bsi, but this was not statistically h. p. loveday et al. / journal of hospital infection s ( ) s -s s signiÀ cant. hicpac identiÀ ed an additional prospective randomised trial that demonstrated a signiÀ cant decrease in the rate of cr-bsi in patients with non-tunnelled cvcs who received continuous heparin infusion. heparin-bonded (hb) catheters have also been shown to reduce the risk of both thrombus formation and cr-bsi. [ ] [ ] [ ] [ ] we identiÀ ed one systematic review of hb cvcs in children. the reviewers identiÀ ed two rcts of children aged day to years who received either an hb catheter or a standard catheter. there was no signiÀ cant difference in the median duration of catheter patency in the two groups: days in the hb catheter group and days in the standard catheter group. the authors also reported a trend towards a reduction in the risk of catheter-related thrombosis and catheter occlusion in the hb group. the risks of catheter colonisation and catheterrelated infection were signiÀ cantly reduced in the treatment group, with a delay to infection in the hb catheter group. however, the reviewers considered the need for further studies to conÀ rm the efÀ cacy of hb catheters. the use of warfarin has also been shown to reduce the risk of catheter-related thrombosis in some patient groups but not in others, and is generally not associated with a reduction in infection-related complications. , - systemic heparin, as either an infusion or Á ush, has a number of side effects that contraindicate its routine use for maintaining the patency of cvcs and preventing thrombus formation; these include thrombocytopenia, allergic reactions and bleeding. normal saline is an alternative to the use of heparin Á ush. hicpac refer to three systematic reviews, and meta-analysis of rcts evaluating the effect of heparin on the duration of catheter patency and on the prevention of complications associated with the use of peripheral venous and arterial catheters concluded that heparin at doses of u/ml for intermittent Á ushing is no more beneÀ cial than Á ushing with normal saline alone. [ ] [ ] [ ] [ ] however, manufacturers of implanted ports or opened-ended catheter lumens may recommend heparin Á ushes for maintaining cvcs that are accessed infrequently. we identiÀ ed one systematic review and two rcts that compared heparin with normal saline to maintain the patency of cvcs and pvcs, respectively. - a systematic review of heparin Á ushing and other interventions to maintain the patency of cvcs concluded that the evidence base for heparin Á ushing and other interventions to prevent catheter occlusion is limited and published studies are of low quality. the reviewers concluded that there is no direct evidence of the effectiveness of heparin Á ushes to prevent cr-bsi or other central line complications. in a single-centre rct of newly placed multi-lumen cvcs in patients in medical icus and surgical/burn/trauma icus, normal saline and heparin Á ush solutions were found to have similar rates of lumen non-patency. given potential safety concerns with the use of heparin, normal saline may be the preferred Á ushing solution for short-term use for cvc maintenance. secondary outcomes for cr-bsi were non-signiÀ cant between groups. a single-centre cluster rct of medical patients found that twice-daily heparin ( u/ml) Á ushes for maintenance of pvcs was more effective than normal saline solution. the number of catheter-related phlebitis/occlusions and the number of catheters per patient was reduced; however, infection outcomes were not measured. ivad do not use systemic anticoagulants routinely to prevent catheter-related bloodstream infection. ivad use sterile normal saline for injection to Á ush and lock catheter lumens that are accessed frequently. needle-free infusion systems and connection devices have been widely introduced to reduce the incidence of sharps injuries and minimise the risk of transmission of bloodborne pathogens to healthcare workers. there is limited evidence that needleless devices or valves reduce the risk of catheter colonisation compared with standard devices. in addition, the design features of some of these devices pose a potential risk for contamination, and have been associated with reports of an increase in bloodstream infection rates. [ ] [ ] [ ] [ ] ivad the introduction of new intravascular devices or components should be monitored for an increase in the occurrence of device-associated infection. if an increase in infection rates is suspected, this should be reported to the medicines and healthcare products regulatory agency in the uk. ivad when safer sharps devices are used, healthcare workers should ensure that all components of the system are compatible and secured to minimise leaks and breaks in the system. hicpac reviewed three well-controlled studies on the optimal interval for the routine replacement of intravenous solution administration sets. a cochrane review of rcts with patients concluded that there is no evidence that changing intravenous administration sets more often than every h reduces the incidence of bloodstream infection. the reviewers were unable to conclude if changing administration sets less often than every h affects the incidence of infection from the studies. there were no differences between participants with central vs peripheral catheters, nor between participants who did and did not receive parenteral nutrition, or between children and adults. administration sets that do not contain lipids, blood or blood products may be left in place for intervals of up to h without increasing the incidence of infection. there is no evidence to suggest that administration sets which contain lipids should not be changed every h as currently recommended. ivad administration sets in continuous use do not need to be replaced more frequently than every h, unless device-speciÀ c recommendations from the manufacturer indicate otherwise, they become disconnected or the intravascular access device is replaced. class a ivad administration sets for blood and blood components should be changed when the transfusion episode is complete or every h (whichever is sooner). ivad administration sets used for lipidcontaining parenteral nutrition should be changed every h. ensuring that patients receive care that is evidence based is an essential element of delivering high-quality health care. in , the department of health issued a series of highimpact interventions that were derived from national and international evidence-based guidelines for the prevention of healthcare-associated infection and based on experience from the institute of healthcare improvement , lives campaign focused on reducing patient harm. the high-impact interventions focused on increasing the reliability of care and ensuring that recommendations were implemented every time for every patient. the intervention for the prevention of infection associated with the use of ivds included six key interventions often referred to as a 'care bundle', together with audit tools to measure adherence. these six practices included: • aseptic insertion of an appropriate device; • correct siting of the device; • effective cutaneous antisepsis; and for continuing care of the device: • hand decontamination and asepsis for any contact with the device; • daily observation of the insertion site; and • clean, intact dressing. a small number of well-designed studies , have described the use of 'bundled' approaches to reducing cr-bsi, and have stimulated individual observational and quality improvement reports of the results of using key evidence-based practices for the prevention of cr-bsi. the most prominent of these was a study conducted in the icu setting of hospitals in the usa, which was then adopted by other countries including the uk. , the authors reported the success of À ve evidence-based practices combined with system and organisational support, which resulted in a % decrease in cr-bsi months after the inception of the programme (incidence rate ratio . , % ci . - . to incidence rate ratio . , % ci . - . ) and sustained reductions thereafter. the intervention comprised: hand hygiene using abhr; msb precautions for insertion; cutaneous antisepsis of the insertion site with % chg; avoiding the femoral site; and removing cvcs as soon as they are no longer clinically indicated. in addition, system changes that prompted the clinician to 'do the right thing' included placing all the equipment needed in a cart for ease of access; the use of a checklist; authorising staff to halt procedures if best practice was not being followed; daily rounds to ensure the timely removal of cvcs; feedback of cr-bsi cases to clinical staff; and organisational support to purchase essential equipment and solutions prior to the start of the study. audit and feedback are an essential component of any quality improvement intervention as this promotes a continuous 'hawthorne effect' and enables staff to maintain vigilance and sustain improvement. the use of dashboards and statistical process control charts alerts clinicians to variability outside control limits, and prompts scrutiny of practice and organisational systems, and remedial action to be taken. we identiÀ ed three additional studies that reported 'bundled interventions' to reduce cr-bsi. [ ] [ ] [ ] none were included in the systematic review as they failed to meet study quality criteria. the features of any quality improvement initiative need to be tailored to the local conditions and may include some or all of the following: • hand hygiene, aseptic insertion using msb precautions (cvc), aseptic technique (pvc), cutaneous antisepsis using % chg in alcohol unless contraindicated, appropriate siting of the cvc or pvc, and prompt removal when no longer indicated; • audit and feedback; • education and training; and • accessibility of equipment and appropriate system changes developed with clinical staff to make best practice the norm. in one cost-effectiveness study, a markov decision model was used to evaluate the cost-effectiveness of a care bundle to prevent cr-bsi. the care bundle included in the model was based on the bundle advocated by the institute for health improvement , lives campaign, comprising optimal hand hygiene, chlorhexidine skin antisepsis, msb precautions for catheter insertion and insertion equipment kit, optimal insertion site and prompt catheter removal. costs included monitoring, education and clinical leadership activities. the authors estimated that the bundle would be cost-effective if the costs of implementation were less than aus$ , (£ , ) per icu. to support the appropriate use and management of intravascular access devices (central and peripheral venous catheters) and ensure their timely removal. these may include: • protocols for device insertion and maintenance; • reminders to review the continuing use or prompt the removal of intravascular devices; • audit and feedback of compliance with practice guidelines; and • continuing professional education. systematic review questions . what types of cvcs (material, coating, antibiotic impregnation, cuffed, tunnelled, midline, picc) and pvcs (material, coating, antibiotic impregnation) are most effective in reducing the risk of cr-bsi and related complications/adverse events including phlebitis, related mortality, catheter tip colonisation and premature line removal? . which cvc/pvc insertion site is associated with the lowest risk of cr-bsi and related complications including phlebitis, related mortality, catheter tip colonisation and premature line removal? . what is the evidence that additional ports or lumens increase the risk of cr-bsi and related complications/adverse events including phlebitis, mortality, catheter tip colonisation and premature line removal? . which infection prevention precautions used for inserting intravascular catheters are most effective in reducing the risk of cr-bsi and related complications/adverse events including phlebitis, catheter tip colonisation, premature line removal and mortality? . what levels of barrier precautions are most effective in reducing the risk of cr-bsi and related complications/adverse events including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the most effective skin antisepsis solution/antiseptic-impregnated product for decontamination of the skin prior to insertion of cvcs and pvcs to reduce the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the effectiveness of antiseptics vs antiseptic-impregnated products (sponges or cloths) for decontaminating skin at the insertion site or surrounding area whilst a cvc or pvc is in situ in reducing the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the evidence for the effectiveness of using antibiotics or antiseptics to lock, Á ush or clean the catheter hub or entry ports of cvcs and pvcs in reducing the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the effectiveness of low-dose systemic anticoagulation to reduce the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . which dressing type is the most clinically effective in reducing the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality, and how frequently should dressings be changed? . what is the optimal frequency to change or re-site pvcs or midline catheters to reduce the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the evidence for the effectiveness of replacing administration sets to reduce the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the effectiveness of the prophylactic administration of systemic antimicrobials in reducing the incidence of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the evidence that the needle-safe devices are associated with increased risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality? . what is the effectiveness of system interventions in reducing the risk of cr-bsi and related complications including phlebitis, catheter tip colonisation, premature line removal and mortality, and improving healthcare workers' knowledge and behaviour relating to the use of central venous access device (cvad) and peripheral vascular device (pvd)? total number of articles located = abstract indicates that the article: relates to infections associated with intravascular access devices; is written in english; is primary research, a systematic review or a meta-analysis; and appears to inform one or more of the review questions. total number of articles retrieved from sift = full text conÀ rms that the article: relates to infections associated with intravascular access devices; is written in english; is primary research (randomised controlled trials, prospective cohort, interrupted time series, controlled before-after, quasi-experimental), a systematic review or a metaanalysis including the above designs; and informs one or more of the review questions. total number of studies selected for appraisal during sift = all articles that described primary research, a systematic review or a meta-analysis and met the sift criteria were independently critically appraised by two appraisers using sign and epoc criteria. consensus and grading was achieved through discussion. total number of studies accepted after critical appraisal = total number of studies rejected after critical appraisal = the epic project: developing national evidence-based guidelines for preventing healthcare associated infections. phase i: guidelines for preventing hospital-acquired infections national evidencebased guidelines for preventing 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adult males. nspca effect of a siliconized latex urinary catheter on bacterial adherence and human neutrophil activity incidence and importance of bacteriuria in postoperative, short-term urinary catheterization types of urethral catheters for management of short-term voiding problems in hospitalized adults: a short version cochrane review a controlled trial of a new material for coating urinary catheters comparison of hydrophilic polymer-coated latex, uncoated latex and pvc indwelling balloon catheters in the prevention of urinary infection the epic project: updating the evidence base for national evidence-based guidelines for preventing healthcareassociated infections in nhs hospitals in england. a report with recommendations types of urethral catheters for management of short-term voiding problems in hospitalised adults the efÀ cacy of silver alloy-coated urinary catheters in preventing urinary tract infection: a meta-analysis management of short term indwelling urethral catheters to prevent urinary tract infections. a systematic review is there evidence for recommending silver-coated urinary catheters in guidelines? clinical application of the bardex ic foley catheter a randomized crossover study of silver-coated urinary catheters in hospitalized patients the potential clinical and economic beneÀ ts of silver alloy urinary catheters in preventing urinary tract infection a comparison of the effect of early insertion of standard latex and silver-impregnated latex foley catheters on urinary tract infections in burn patients using silver to reduce catheter-associated urinary tract infections the impact of using silver alloy urinary catheters in reducing the incidence of urinary tract infections in the critical care setting effect of silver-coated urinary catheters: efÀ cacy, cost-effectiveness, and antimicrobial resistance a rapid method of impregnating endotracheal tubes and urinary catheters with gendine: a novel antiseptic agent gentamicin-releasing urethral catheter for short-term catheterization randomized multicentre trial of the effects of a catheter coated with hydrogel and silver salts on the incidence of hospital-acquired urinary tract infections use of silver-hydrogel urinary catheters on the incidence of catheter-associated urinary tract infections in hospitalized patients evaluation of the antimicrobial efÀ cacy of urinary catheters impregnated with antiseptics in an in vitro urinary tract model efÀ cacy of antimicrobialimpregnated bladder catheters in reducing catheter-associated bacteriuria: a prospective, randomized, multicenter clinical trial assessment of nosocomial urinary tract infections in orthopaedic patients: a prospective and comparative study using two different catheters a large randomized clinical trial of a silver-impregnated urinary catheter: lack of efÀ cacy and staphylococcal superinfection prevention of catheter-associated urinary tract infection with a silver oxide-coated urinary catheter: clinical and microbiologic correlates reÀ nements in the coating of urethral catheters reduces the incidence of catheter-associated bacteriuria. an experimental and clinical study silver alloy coated catheters reduce catheter-associated bacteriuria antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial preventing hospital-acquired infection: clinical guidelines. london: public health laboratory service philadelphia: lippincott-raven entry of bacteria into the urinary tracts of patients with inlying catheters technical advances in the prevention of urinary tract infection prevention of catheter-induced urinary-tract infections by sterile closed drainage factors predisposing to bacteriuria during indwelling urethral catheterization bacteriuria during indwelling catheter drainage: ii. effect of a closed sterile draining system does the addition of disinfectant to urine drainage bags prevent infection in catheterised patients? prevention of urinary tract infection in gynaecology reduction of mortality associated with nosocomial urinary tract infection incidence of urinary tract infections in patients with short-term indwelling urethral catheters: a comparison between a -day urinary drainage bag change and no change regimens decreased incidence of bacteriuria associated with periodic instillations of hydrogen peroxide into the urethral catheter drainage bag evaluation of h o prophylaxis of bacteriuria in patients with long-term indwelling foley catheters: a randomized controlled study catheter-associated bacteriuria. failure to reduce attack rates using periodic instillations of a disinfectant into urinary drainage systems prevention of bacteriuria in female patients with indwelling catheters prevention of catheter-associated urinary tract infections. efÀ cacy of daily meatal care regimens evaluation of daily meatal care with poly-antibiotic ointment in prevention of urinary catheter-associated bacteriuria prevention of catheter-associated bacteriuria: clinical trial of methods to block three known pathways of infection daily meatal care for prevention of catheter-associated bacteriuria: results using frequent applications of polyantibiotic cream randomized trial of meatal care with silver sulfadiazine cream for the prevention of catheter-associated bacteriuria water or antiseptic for periurethral cleaning before urinary catheterization: a randomized controlled trial does instillation of chlorhexidine into the bladder of catheterized geriatric patients help reduce bacteriuria? bladder irrigation with chlorhexidine for the prevention of urinary infection after transurethral operations: a prospective controlled study controlled trial of intravesical noxythiolin in the prevention of infection following outÁ ow tract surgery a randomized study on the effect of bladder irrigation with povidone-iodine before removal of an indwelling catheter antibiotic irrigation and catheter-associated urinary-tract infections once-daily irrigation of long-term urethral catheters with normal saline. lack of beneÀ t assessment of the use of bladder washouts/instillations in patients with long-term indwelling catheters neomycin-polymyxin prophylaxis of urinary-tract infection associated with indwelling catheters the use of bladder wash-outs to reduce urinary catheter encrustation closing the quality gap: a critical analysis of quality improvement strategies evaluating the efÀ cacy of the infection control liaison nurse in the hospital guidelines for the prevention of intravascular catheter-related infections nosocomial bloodstream infection in critically ill patients. excess length of stay, extra costs, and attributable mortality is routine replacement of peripheral intravenous catheters necessary? peripheral teÁ on catheters: factors determining incidence of phlebitis and duration of cannulation phlebitis rate and time kinetics of short peripheral iv catheters routine versus clinically indicated replacement of peripheral intravenous catheters: a randomised controlled equivalence trial the risk of bloodstream infection in adults with different intravascular devices: a systematic review of published prospective studies nosocomial bloodstream infections in us hospitals: analysis of , cases from a prospective nationwide surveillance study national nosocomial infections surveillance system. overview of nosocomial infections caused by gram-negative bacilli the pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters saraÀ n hw. a semiquantitative culture method for identifying intravenous-catheter-related infection the pathogenesis and epidemiology of catheter-related infection with pulmonary artery swan-ganz catheters: a prospective study utilizing molecular subtyping ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement dna À ngerprinting analysis of coagulase negative staphylococci implicated in catheter related bloodstream infections colonization and infrequent hematogenous seeding in catheterrelated infections optimal frequency of changing intravenous administration sets: is it safe to prolong use beyond hours? effectiveness of surveillance of central catheter-related bloodstream infection in an icu in korea effect of an education program on decreasing catheter-related bloodstream infections in the surgical intensive care unit education of physiciansin-training can decrease the risk for vascular catheter infection impact of a prevention strategy targeted at vascularaccess care on incidence of infections acquired in intensive care septic complications of total parenteral nutrition. a À ve year experience catheter complications in total parenteral nutrition. a prospective study of consecutive patients central venous catheter care in parenteral nutrition: a review prospective study of catheter replacement and other risk factors for infection of hyperalimentation catheters educational interventions for preventing vascular catheter bloodstream infections in critical care: evidence map, systematic review and economic evaluation total parenteral nutrition-related infections: prospective epidemiologic study using semiquantitative methods colonization of bacteria on polyvinyl chloride and teÁ on intravascular catheters in hospitalized patients evaluation of dressing regimens for prevention of infection with peripheral intravenous catheters. gauze, a transparent polyurethane dressing, and an iodophortransparent dressing sepsis from triplevs single-lumen catheters during total parenteral nutrition in surgical or critically ill patients prospective evaluation of single and triple lumen catheters in total parenteral nutrition central catheter infections: single-versus triple-lumen catheters. inÁ uence of guide wires on infection rates when used for replacement of catheters infection rate for single lumen v triple lumen subclavian catheters use of triple-lumen subclavian catheters for administration of total parenteral nutrition increased infection rate in double-lumen versus single-lumen hickman catheters in cancer patients single-versus triple-lumen central catheter-related sepsis: a prospective randomized study in a critically ill population triple-vs single-lumen central venous catheters. a prospective study in a critically ill population rates of infection for single-lumen versus multilumen central venous catheters: a meta-analysis colonization and bloodstream infection with single-versus multi-lumen central venous catheters: a quantitative systematic review guideline for prevention of intravascular devicerelated infections. hospital infection control practices advisory committee a prospective study of prolonged central venous access in leukemia broviac catheter-related bacteremia in oncology patients hickman catheter infections in patients with malignancies problems associated with indwelling central venous catheters complications of hickman-broviac catheters management of hickman catheter sepsis catheter-related septicemia in patients receiving home parenteral nutrition single-vs double-lumen central venous catheters in pediatric oncology patients bacteraemia related to indwelling central venous catheters: prevention, diagnosis and treatment low infection rate and long durability of nontunneled silastic catheters. a safe and costeffective alternative for long-term venous access lack of clinical beneÀ t from subcutaneous tunnel insertion of central venous catheters in immunocompromised patients a totally implanted injection port system for blood sampling and chemotherapy administration complications and management of implanted venous access catheters a totally implanted venous access system for the delivery of chemotherapy implantable subcutaneous venous catheters fifty-À ve patient years' experience with a totally implanted system for intravenous chemotherapy infection rates of broviac-hickman catheters and implantable venous devices complications from long-term indwelling central venous catheters in hematologic patients with special reference to infection classical external indwelling central venous catheter versus totally implanted venous access systems for chemotherapy administration: a randomized trial in patients with solid tumors comparison of infections in hickman and implanted port catheters in adult solid tumor patients experience with a totally implantable venous access device (port-a-cath) in patients with aids infectious morbidity associated with long-term use of venous access devices in patients with cancer long-term central venous access effect of subcutaneous tunneling on internal jugular catheter-related sepsis in critically ill patients: a prospective randomized multicenter study use of tunneled femoral catheters to prevent catheter-related infection. a randomized, controlled trial tunneling short-term central venous catheters to prevent catheter-related infection: a meta-analysis of randomized, controlled trials peripheral access options long-term intravenous therapy with peripherally inserted silicone elastomer central venous catheters in patients with malignant diseases infectious complications among patients receiving home intravenous therapy with peripheral, central, or peripherally placed central venous catheters peripherally inserted central venous catheters. low-risk alternatives for ongoing venous access survey of the use of peripherally inserted central venous catheters in children peripherally inserted central catheters in patients with aids are associated with a low infection rate risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter. a randomized, controlled trial evaluation of chlorhexidine and silver-sulfadiazine impregnated central venous catheters for the prevention of bloodstream infection in leukaemic patients: a randomized controlled trial inÁ uence of triple-lumen central venous catheters coated with chlorhexidine and silver sulfadiazine on the incidence of catheter-related bacteremia a meta-analysis dealing with the effectiveness of chlorhexidine and silver-sufhadiazine impregnated central venous catheters anaphylactic shock induced by an antiseptic-coated central venous [correction of nervous] catheter cost-effectiveness of antiseptic-impregnated central venous catheters for the prevention of catheter-related bloodstream infection central venous catheters coated with minocycline and rifampin for the prevention of catheter-related colonization and bloodstream infections. a randomized, double-blind trial. the texas medical center catheter study group decreasing catheter colonization through the use of an antiseptic-impregnated catheter: a continuous quality improvement project a comparison of two antimicrobial-impregnated central venous catheters efÀ cacy of antiseptic-impregnated central venous catheters in preventing catheter-related bloodstream infection: a meta-analysis prevention of intravascular catheter-related infections prevention of bloodstream infections with central venous catheters treated with antiinfective agents depends on catheter type and insertion time: evidence from a meta-analysis prolonged antimicrobial activity of a catheter containing chlorhexidine-silver sulfadiazine extends protection against catheter infections in vivo the clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematic review and economic evaluation catheter impregnation, coating or bonding for reducing central venous catheter-related infections in adults effectiveness of different central venous catheters for catheterrelated infections: a network meta-analysis anti-infective external coating of central venous catheters: a randomized, noninferiority trial comparing -Á uorouracil with chlorhexidine/silver sulfadiazine in preventing catheter colonization immediate hypersensitivity to chlorhexidine is increasingly recognised in the united kingdom anaphylaxis to chlorhexidine-coated central venous catheters: a case series and review of the literature medical device alert: all medical devices and medicinal products containing chlorhexidine. mda/ / . london: medicines and healthcare products regulatory agency femoral vs jugular venous catheterization and risk of nosocomial events in adults requiring acute renal replacement therapy: a randomized controlled trial impact of central venous catheter type and methods on catheter-related colonization and bacteraemia to reduce catheterrelated bloodstream infections: is the subclavian route better than the jugular route for central venous catheterization? complications of central venous catheters: internal jugular versus subclavian access -a systematic review comparison between the jugular and subclavian vein as insertion site for central venous catheters: microbiological aspects and risk factors for colonization and infection prospective multicenter study of vascular-catheter-related complications and risk factors for positive central-catheter cultures in intensive care unit patients a review of risk factors for catheter-related bloodstream infection caused by percutaneously inserted, noncuffed central venous catheters: implications for preventive strategies the micro-organism responsible for central venous catheter s s -s related bloodstream infection depends on catheter site prospective study of arterial and central venous catheter colonization and of arterial-and central venous catheter-related bacteremia in intensive care units complications of femoral and subclavian venous catheterization in critically ill patients: a randomized controlled trial risk of infection due to central venous catheters: effect of site of placement and catheter type the incidence of infectious complications of central venous catheters at the subclavian, internal jugular, and femoral sites in an intensive care unit population the risk of catheter-related bloodstream infection with femoral venous catheters as compared to subclavian and internal jugular venous catheters: a systematic review of the literature and meta-analysis ultrasound guidance for placement of central venous catheters: a metaanalysis of the literature ultrasonic locating devices for central venous cannulation: meta-analysis guidance on the use of ultrasound locating devices for placing central venous catheters infection control in intravenous therapy prevention of central venous catheter-related infections by using maximal sterile barrier precautions during insertion effect of different sterile barrier precautions and central venous catheter dressing on the skin colonization around the insertion site using maximal sterile barriers to prevent central venous catheter-related infection: a systematic evidence-based review catheter-related sepsis: an overview -part prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters prospective, randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter colonization and infection in intensive care unit patients alcoholic povidone-iodine to prevent central venous catheter colonization: a randomized unit-crossover study chlorhexidine compared with povidone-iodine solution for vascular cathetersite care: a meta-analysis vascular catheter site care: the clinical and economic beneÀ ts of chlorhexidine gluconate compared with povidone iodine guideline for use of topical antimicrobial agents catheter-related sepsis in long-term parenteral nutrition with broviac catheters. an evaluation of different disinfectants colonization of central venous catheters a clinical and bacteriologic study of infections associated with venous cutdowns application of antibiotic ointment to the site of venous catheterization -a controlled trial risk of infection with intravenous indwelling catheters: effect of application of antibiotic ointment the effects of antibiotic ointments and antiseptics on the skin Á ora beneath subclavian catheter dressings during intravenous hyperalimentation a comparative study of polyantibiotic and iodophor ointments in prevention of vascular catheter-related infection the forgotten role of alcohol: a systematic review and meta-analysis of the clinical efÀ cacy and perceived role of chlorhexidine in skin antisepsis transparent polyurethane À lm as an intravenous catheter dressing. a metaanalysis of the infection risks gauze and tape and transparent polyurethane dressings for central venous catheters gauze and tape and transparent polyurethane dressings for central venous catheters using the collaborative evidence based practice model: a systematic review and uptake of chlorhexidine-impregnated sponge dressings on central venous access devices in a tertiary cancer centre economic evaluation of chlorhexidine-impregnated sponges for preventing catheterrelated infections in critically ill adults in the dressing study randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults the efÀ cacy of daily bathing with chlorhexidine for reducing healthcareassociated bloodstream infections: a meta-analysis skin disinfection with octenidine dihydrochloride for central venous catheter site care: a double-blind, randomized, controlled trial catheterrelated sepsis: prospective, randomized study of three methods of long-term catheter maintenance changing subclavian haemodialysis cannulas to reduce infection a controlled trial of scheduled replacement of central venous and pulmonary-artery catheters central venous catheter replacement strategies: a systematic review of the literature routine resite of peripheral intravenous devices every days did not reduce complications compared with clinically indicated resite: a randomised controlled trial clinically-indicated replacement versus routine replacement of peripheral venous catheters source and route of microbial colonisation of parenteral nutrition catheters catheter sepsis due to coagulase-negative staphylococci in patients on total parenteral nutrition a prospective study of the catheter hub as the portal of entry for microorganisms causing catheter-related sepsis in neonates adherence and growth of coagulase-negative staphylococci on surfaces of intravenous catheters pathogenesis of catheter sepsis: a prospective study with quantitative and semiquantitative cultures of catheter hub and segments a randomized trial on the effect of tubing changes on hub contamination and catheter sepsis during parenteral nutrition contamination of stopcocks mounted in administration sets for central venous catheters with replacement at hrs versus hrs: a prospective cohort study use of disinfectants to reduce microbial contamination of hubs of vascular catheters effectiveness of disinfectant techniques on intravenous tubing latex injection ports a randomized, prospective clinical trial to assess the potential infection risk associated with the posiflow ® needleless connector scrub the hub': cleaning duration and reduction in bacterial load on central venous catheters successful disinfection of needleless access ports: a matter of time and friction antibiotic-based catheter lock solutions for prevention of catheter-related bloodstream infection: a systematic review of randomised controlled trials prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial guidelines for the prevention of intravascular-catheter-related infections can high-level mupirocin resistance reporting be relied upon to ensure patients are prescribed appropriate treatment? prophylactic antibiotics for preventing early central venous catheter gram positive infections in oncology patients heparin bonding reduces thrombogenicity of pulmonaryartery catheters central venous access sites for the prevention of venous thrombosis, stenosis and infection the relationship between the thrombotic and infectious complications of central venous catheters thrombosis as a complication of pulmonary-artery catheterization via the internal jugular vein: prospective evaluation by phlebography central vein thrombosis associated with intravenous feeding -a prospective study a cross-sectional study of catheter-related thrombosis in children receiving total parenteral nutrition at home catheter-related thrombosis in critically ill children: comparison of catheters with and without heparin bonding a prospective study of femoral catheter-related thrombosis in children beneÀ t of heparin in central venous and pulmonary artery catheters: a meta-analysis of randomized controlled trials very low doses of warfarin can prevent thrombosis in central venous catheters. a randomized prospective trial randomized trial of prevention of catheter-related bloodstream infection by continuous infusion of low-dose unfractionated heparin in patients with hematologic and oncologic disease heparin-bonded central venous lines reduce thrombotic and infective complications in critically ill children surface heparinization of central venous catheters reduces microbial colonization in vitro and in vivo: results from a prospective, randomized trial use of heparincoated central venous lines to prevent catheter-related bloodstream infection heparin-bonded catheters for prolonging the patency of central venous catheters in children prevention of central venous catheter associated thrombosis using minidose warfarin in patients with haematological malignancies anticoagulation for thrombosis prophylaxis in cancer patients with central venous catheters anticoagulation in patients with cancer: an overview of reviews thrombosis prophylaxis in patient populations with a central venous catheter: a systematic review the heparin Á ush syndrome: a cause of iatrogenic hemorrhage beneÀ t of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials a meta-analysis of effects of heparin Á ush and saline Á ush: quality and cost implications analysis of the research about heparinized versus nonheparinized intravascular lines heparin Á ushing and other interventions to maintain patency of central venous catheters: a systematic review heparin or . % sodium chloride to maintain central venous catheter patency: a randomized trial intermittent Á ushing with heparin versus saline for maintenance of peripheral intravenous catheters in a medical department: a pragmatic clusterrandomized controlled study outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve increased rate of catheter-related bloodstream infection associated with use of a needleless mechanical valve device at a long-term acute care hospital increased catheterrelated bloodstream infection rates after the introduction of a new mechanical valve intravenous access port incidence of catheterrelated bloodstream infection among patients with a needleless, mechanical valve-based intravenous connector in an australian hematology-oncology unit optimal timing for intravenous administration set replacement saving lives: a delivery programme to reduce healthcare associated infection including mrsa. london: department of health eliminating catheter-related bloodstream infections in the intensive care unit an intervention to decrease catheter-related bloodstream infections in the icu sustaining reductions in catheter related bloodstream infections in michigan intensive care units: observational study results of a multicentre randomised controlled trial of statistical process control charts and structured diagnostic tools to reduce ward-acquired meticillin-resistant staphylococcus aureus: the chart project a multifaceted intervention for quality improvement in a network of intensive care units: a cluster randomized trial effectiveness of stepwise interventions targeted to decrease central catheterassociated bloodstream infections matching michigan': a -year stepped interventional programme to minimise central venous catheter-blood stream infections in intensive care units in england costeffectiveness of a central venous catheter care bundle the , lives campaign: setting a goal and deadline for improving healthcare quality an initial search was made for national and international guidelines and systematic reviews of randomised controlled trials. search questions were based on the scope of the original review and advice from the guideline development group. databases to be searched were identiÀ ed together with search strategy [i.e. relevant medical subject headings (mesh), free-text and thesaurus terms]. abstracts of all articles retrieved from the search were reviewed against pre-determined inclusion criteria (e.g. relevant to a review question, primary research/systematic review/meta-analysis, written in english). full text of all articles that met the inclusion criteria was reviewed against pre-determined criteria to identify primary research which answers review questions. all articles that described primary research, a systematic review or a meta-analysis were critically appraised by two experienced appraisers. consensus and grading was achieved through discussion in the context of pre-determined grading criteria. the following organisations were approached for comment: a chemical compound that contains 'energy-rich bonds' and is used by cells to store and deliver energy an organism that requires free oxygen for life and growth a hand decontamination preparation based on alcohol that, for the purposes of these guidelines, encompasses solutions, gels or wipes antimicrobial a substance that kills or inhibits the growth of microorganisms the absence of pathogenic microorganisms antiseptic a substance that destroys or inhibits the growth of microorganisms and is sufÀ ciently non-toxic to be applied to skin or mucous membranes a framework for the aseptic technique based on the concept of deÀ ning key parts and key sites to be protected from contamination. a carefully controlled procedure that aims to prevent contamination by microorganisms the presence of microorganisms in the bloodstream the presence of microorganisms in the urine. if there are no symptoms of infection, this is called 'asymptomatic bacteriuria' a complex structure comprising microorganisms and extracellular polymers that forms over surfaces, such as those in contact with water or tissues continuous Á ow of a solution through the bladder to remove clots or debris a viral infection transmitted by exposure to blood and sometimes other bodily Á uids. bloodborne viruses include hepatitis b and c as well as human immunodeÀ ciency virus the presence of microbes in the blood with symptoms of infection an analytical observational study that compares people with the disease of interest with a group of similar 'control' people who do not in order to determine potential causes or risk factors a scientiÀ c article that describes an individual case in detail a report describing a series of several similar events the presence of symptoms or signs attributable to microorganisms that have infection (cauti)invaded the urinary tract, where the patient has, or has recently had, a urinary catheter microorganisms present on a surface of a catheter that could potentially lead to infection an infection of the bloodstream where microorganisms are found in the blood infection (cr-bsi) of a patient with a central venous access device, the patient has clinical signs of infection (e.g. fever, chills and hypotension) and there is no other apparent source for the infection. for surveillance purposes, this often refers to bloodstream infections that occur in patients with a central venous access device and where other possible sources of infection have been excluded. a more rigorous deÀ nition is where the same microorganism is cultured from the tip of the catheter as grown from the blood; simultaneous quantitative blood cultures with at least a : ratio of microorganisms cultured from the central venous access device vs peripheral; differential time to positivity of at least h for blood cultures cultured peripherally vs from central venous access device waste material that consists wholly or partly of human or animal tissue, blood or body Á uids, excretions, drugs or other pharmaceutical products, swabs/ dressings, syringes, needles or other sharp instruments closed urinary drainage system a system where a urinary catheter is connected via tubing to a collecting bag.the system relies on gravity to drain the urine a prospective or retrospective follow-up study where groups to be followed-up are deÀ ned on the basis of presence or absence of exposure to a risk factor or intervention microorganisms that establish themselves in a particular environment, such as a body surface, without producing disease an estimate of the number of viable bacterial cells made by counting visible colonies derived from the replication of a single microbial cell transmission of a pathogenic organism from one person to another a comparison of the outcome between two or more groups of patients that are exposed to different regimens of treatment/intervention where the groups exchange treatment/intervention after a pre-arranged period a process that removes hazardous substances, including chemicals or microorganisms a cleansing agent that removes dirt from a surface by bonding with lipids and other particles a process that reduces the number of pathogenic microorganisms to a level at which they are not able to cause harm, but which does not usually destroy spores particles - õm in diameter comprising the dried residue formed by evaporation of droplets coughed or sneezed from the respiratory tract difÀ cult or painful urination urinary proteins, salts and crystals that adhere to the internal and external surface of a urinary catheter the use of equipment designed to prevent injury to the operator administration of nutrients into stomach or other part of the gastrointestinal tract using tubes infections caused by microorganisms acquired from another person, animal or the environment opinion derived from seminal works and appraised national and international guidelines the type of bacteria as identiÀ ed by gram's staining method. gram-positive bacteria appear dark blue or purple under a microscope. such bacteria have a thick layer of peptidoglycan on their cell walls. gram-negative bacteria appear red under a microscope and have an outer layer of lipoprotein and a thin layer of peptidoglycan a wire used to facilitate insertion of the intravascular catheter into the body blood in the pleural cavity, usually due to injury. if the blood is not drained, it may impair the movement of the lungs or become infected the use of soap and water or an antiseptic solution to reduce the number of microorganisms on the hands a phenomenon in which the participants change their behaviour or performance in response to being studied infection acquired as a result of the delivery of health care either in an acute (hospital) or non-acute setting any person employed by a health service, social service, local authority or agency to provide care for sick, disabled or elderly people a central venous access device that is tunnelled under the skin with a subcutaneous port or reservoir with a self-sealing septum that is accessible by needle puncture through intact skin the number of new events (e.g. cases of disease) occurring in a population over a deÀ ned period of time a catheter inserted into the bladder via the urethra and left in place for a period of time microorganisms that have entered the body and are multiplying in the tissues, typically causing speciÀ c symptoms an analysis in which the results of the study are based on initial treatment assignment and not on a treatment actually received a study in which measurements from the group under investigation are taken repeatedly before and after the intervention a device inserted into a vascular system in order to administer Á uids, medicines and nutrients or to obtain blood samples. these include devices inserted peripherally, as well as those inserted into larger veins any device that requires insertion through skin or other normal body defences a system of attaching catheters, syringes, tubes and any other components of ivad to each other external opening of the urethra the combination of data from several studies to produce a single estimate of an effect of a particular intervention strains of s. aureus that are resistant to many of the antibiotics commonly staphylococcus aureus (mrsa) used to treat infections. epidemic strains also have a capacity to spread easily from person to person a long peripheral venous catheter inserted in the antecubital vein and advanced to a vein in the upper arm. designed for short-term (up to weeks) intravenous access a membrane lining many tubular structures and cavities such as respiratory tractneedle-free devices (also needleless intravascular connector systems developed to help reduce the incidence of intravascular catheter connectors) needlestick injury while facilitating medication delivery through intravascular catheters. there are three types of needle-free connectors: blunt cannula (two-piece) systems, one-piece needle-free systems, and one-piece needlefree systems with positive pressure needle safety device (also needle any device designed to reduce the risk of injury associated with a protection/prevention device) contaminated needle. this may include needle-free devices or mechanisms on a needle, such as an automated resheathing device, that cover the needle immediately after use the puncture of skin by a contaminated needle or other sharp medical device abnormal decrease in the number of neutrophils in peripheral blood, which results in increased susceptibility to infections nitrile a synthetic rubber made from organic compounds and cyanide a retrospective or prospective study in which the investigator observes participants, with or without control groups any derivative of a living or once-living organism two or more cases of the same disease where there is evidence of an epidemiological link between them administration of nutrients by an infusion into a vein h. p. loveday et al. / journal of hospital infection s ( ) s -s particulate À lter masks (or respirator masks) face masks designed to protect the wearer from inhaling airborne particles including microorganisms. they are made to deÀ ned performance standards that include À ltration efÀ ciency. to be effective, they must be À tted close to the face to minimise leakage pathogen a microorganism that causes disease an independent assessment or evaluation of the research by a professional with knowledge of the À eld an injury that results in a sharp instrument/object (e.g. needle, scalpel) puncturing the skin a vascular catheter inserted into the superior vena cava from the basilic or catheter (picc) cephalic vein specialised clothing or equipment worn to protect against substances or situations that present a hazard to health or safety post-exposure prophylaxis drug treatment regimen administered as soon as possible after an occupational exposure to reduce the risk of acquisition of a bloodborne virus a topical preparation used for antisepsis of the skin in a form of solution or ointment the number of events (e.g. cases of disease) present in a deÀ ned population at one point in time study in which people are entered into the research and then followed-up over a period of time with events recorded as they happen a small, Á exible tube placed into a peripheral vein for the safe infusion of medications, hydration Á uids, blood products and nutritional supplements quasi-experimental research designs speciÀ cally lack the element of random assignment of participants (individuals or clinical settings/units) to the treatment or the control group. randomisation minimises the risk that patients entered into the control and treatment groups will be different an rct is a clinical trial where at least two treatment groups are compared, non-randomised controlled trial (nrct) one of them serving as the control group. allocation to the group uses a random, unbiased method. an nrct compares a control and treatment group but allocation to each group is not random. bias is more likely to occur in an nrct microorganisms that live in the deeper crevices of skin and hair follicles. these form part of the normal Á ora of the body and are not readily transferred to other people or objects, or removed by the mechanical action of soap and water. they can be reduced in number with the use of antiseptic soap a mask that covers the mouth and nose to prevent droplets from the wearer being expelled into the environment. as they are also Á uid repellent, they provide some protection for the wearer against exposure of mucous membranes to splashes of blood/body Á uid research that summarises the evidence on a clear question according to a deÀ ned protocol using explicit and systematic methods to identify, select and appraise relevant studies and extract, collate and report their À ndings an infection where the pathogen is distributed throughout the body, rather than being concentrated in one area the decontamination of a room or patient area after a patient has been transferred or discharged in order to ensure that any dirt, dust or contamination by potentially pathogenic microorganisms is removed before use by another patient a reduction in the number of platelets (thrombocytes) in the blood. this may result in bleeding into the skin, spontaneous bruising or prolonged bleeding after injury a clot in a blood vessel caused by coagulation of blood phlebitis (vein inÁ ammation) related to a thrombus (blood clot) microorganisms acquired on the skin through contact with surfaces. the hostile environment of skin means that they can usually only survive for a short time, but they are readily transferred to other surfaces touched. can be removed by washing with soap and water, and most are destroyed by alcohol-based hand rubs the invasion of the tissues of the bladder by microorganisms causing symptoms or signs of infection such as dysuria, loin pain, suprapubic tenderness, fever, pyuria and confusion key: cord- -pne qolr authors: yassi, annalee; bryce, elizabeth a; breilh, jaime; lavoie, marie-claude; ndelu, lindiwe; lockhart, karen; spiegel, jerry title: collaboration between infection control and occupational health in three continents: a success story with international impact date: - - journal: bmc int health hum rights doi: . / - x- -s -s sha: doc_id: cord_uid: pne qolr globalization has been accompanied by the rapid spread of infectious diseases, and further strain on working conditions for health workers globally. post-sars, canadian occupational health and infection control researchers got together to study how to better protect health workers, and found that training was indeed perceived as key to a positive safety culture. this led to developing information and communication technology (ict) tools. the research conducted also showed the need for better workplace inspections, so a workplace audit tool was also developed to supplement worker questionnaires and the ict. when invited to join ecuadorean colleagues to promote occupational health and infection control, these tools were collectively adapted and improved, including face-to-face as well as on-line problem-based learning scenarios. the south african government then invited the team to work with local colleagues to improve occupational health and infection control, resulting in an improved web-based health information system to track incidents, exposures, and occupational injury and diseases. as the h n pandemic struck, the online infection control course was adapted and translated into spanish, as was a novel skill-building learning tool that permits health workers to practice selecting personal protective equipment. this tool was originally developed in collaboration with the countries from the caribbean region and the pan american health organization (paho). research from these experiences led to strengthened focus on building capacity of health and safety committees, and new modules are thus being created, informed by that work. the products developed have been widely heralded as innovative and interactive, leading to their inclusion into “toolkits” used internationally. the tools used in canada were substantially improved from the collaborative adaptation process for south and central america and south africa. this international collaboration between occupational health and infection control researchers led to the improvement of the research framework and development of tools, guidelines and information systems. furthermore, the research and knowledge-transfer experience highlighted the value of partnership amongst northern and southern researchers in terms of sharing resources, experiences and knowledge. working conditions for health workers are undergoing rapid change [ ] . new methods for diagnosis and treatment of diseases, combined with rapid communication technology, makes the world's ability to communicate and disseminate new knowledge remarkably effective; the speed with which the sars outbreak was controlled [ ] and pandemic h n information transmitted are clear illustrations [ ] . on the other hand, economic globalization is severely straining healthcare resources, preferentially benefiting richer countries [ , ] . the changes in labour flow [ ] and trends to deregulation [ , ] also impact the health and well-being of the labour force. international travel, representing million passengers in [ ] , adds complexity in preventing and reducing rapid transmission of infectious diseases across borders. rapid travel has intensified the global need for consistent application of infection control principles to ensure the safety of patients, hospital visitors and health workers. healthcare acquired infections (hais) are often linked to invasive devices, longer hospital stays and more time spent in intensive care [ ] . these infections make up a substantial proportion of the infectious disease burden in high income as well as in low and middle-income countries (lmics) [ ] . the risk of a hai is - times higher in lmics than in high income countries, and this may be an underestimate, due to differences in the intensity of surveillance [ , ] . an estimated % of patients could suffer from preventable hais [ ] . along with patients, healthcare workers are also at high risk of exposure to biological agents in healthcare settings [ , ] . almost half the cases of sars were in health workers [ ] , % of the hepatitis b and c that occurs in health workers is estimated to be due to occupational exposures [ , , ] , and health workers have a high risk of multiple drug-resistant tuberculosis [ ] . to protect the health and safety of patients and health workers in all countries, infection control and occupational health professionals must work closely together. our interdisciplinary international collaboration has contributed to produce practical tools such as guidelines, online and face-to-face training products, checklists, research materials, frameworks and a health information system. this innovative participatory paradigm that has been widely embraced by collaborators and front line health workers. post-sars epidemic, the canadian-based team (led by co-authors ay, an occupational health researcher, and eab, an infection control specialist) conducted research to ascertain the determinants of sustainable adherence to appropriate infection control practices, refining a framework on individual, organizational and environmental factors [ ] . in a survey of , workers across sixteen hospitals in british columbia the team found that health workers who rated the environmental protective measures highly at their institutions were times more likely to report a high level of compliance with appropriate personal protective practices compared to those who did not rate this factor highly at their institutions. similarly, those who perceived organizational factors in the workplace to be consistent with safe practices were times more likely to report good compliance. interestingly, though, there was no association with the individual factors previously thought to be pivotal in affecting compliance [ ] . next, a survey of infection control and occupational health resources and a questionnaire completed by healthcare workers were compared with on-site observational audits in facilities in british columbia and ontario. health workers believed that plans were available to protect against future sars-like events but audits revealed that these did not exist in many facilities. both occupational health and infection control were underresourced post-sars, with occupational health professionals particularly lacking in british columbia. there was a discrepancy between health workers' perception of what was available and what is actually accessible in facilities [ ] , highlighting the need for better communication. the findings from our initial research in canada led to our developing an evidence-based workplace assessment tool. our initial research in canada also showed that training health workers was significantly associated with health worker perception of a positive safety culture in their healthcare workplace [ , ] . one of the identified constraints was the limited quantity of information that could be presented at group sessions due to the time restrictions. these sessions were insufficient to build knowledge and good practices on the selection and use of personal protective equipment [ ] . these research observations were the impetus for our developing online infection control courses that were self-directed, flexible, interactive, and relevant to day-to-day work activities [ , ] . in the region of the americas, our team collaborated with the pan american health organization (paho) on a project related to the prevention of occupational transmission of infectious diseases among health workers. in collaboration with the ministry of health from ecuador, the team members collectively adapted the canadian workplace assessment tool and questionnaire to assess knowledge, attitudes and practices in three hospitals in ecuador (two in quito and one in the amazon) [ ] [ ] [ ] . the workplace assessment tool comprises a list of occupational hazards, including physical, chemical, biological, ergonomic, safety, and psychological hazards. under each hazard classification, the evaluator completes the workplace assessment form by indicating whether the environment and practices are satisfactory, require correction but are not an immediate hazard, or require immediate correction. using the results of the questionnaire and needs assessment, local colleagues identified strengths and challenges at each healthcare facility and initiated projects to address the issues unearthed. for example, campaigns were begun to improve hand hygiene and reduce needlestick injuries, as well as implement muchneeded renovations in the emergency department of one of the hospitals [ ] all priorities identified by using the tools developed. following the success of this initial work in canada and ecuador, the government of the republic of south africa (through co-author ln) invited our team to lead a healthy hospital initiative in that country. again, working closely with local colleagues, we revised the assessment tools, then invited participants to a three-day workshop on occupational health and infection control to complete the initial survey. invited participants included all the representatives elected from the workforce to serve as health and safety representatives as well as the occupational health and infection control staff members from pelonomi hospital, the health facility selected for our pilot study [ ] . the participants were then divided into ten groups to conduct workplace audits, covering five domains; physical environment, specific occupational health practices and hazards, specific infection control practices, equipment and procedures, and ergonomics. training sessions were also conducted specifically for medical practitioners, a usually hard-to-reach population, as the canadian-based research also confirmed [ , ] . having identified the need for better data collection instruments, we developed the occupational health and safety information system (ohasis), a web-based health information system, to track incidents, exposures, risk factors, immunizations and occupational injury and diseases. based on experience in canada [ ] , we ensured that this system particularly focused on preventing hais in health workers. we then began the process of implementation and evaluation [ , ] . meanwhile, paho invited our team to assist in preparing health workers for the global summit and the pan american games in trinidad and tobago. the workplace audit tool, developed originally in canada by the team (comprised of experts in program evaluation, infection control, occupational health, information technology, public health and medicine), and refined from use in ecuador and south africa, was again adapted and workshops held to train occupational health and infection control practitioners from countries across the caribbean. the audit tool is a structured form, which enables healthcare workers to evaluate their working environment in a systematic manner. health and safety professionals have noted that the tool has enabled them to set priorities and act upon identified needs. a novel animated skill-building tool that permits health workers to practice selecting and wearing personal protective equipment was also developed for the caribbean training (http://www.ghrpinnovation.com/protectpatti/eng/index. html). in collaboration with paho, the basic infection control course originally developed in canada post sars was then translated into spanish (http://www.ghrpinnovation.com/ infectioncontrol), with input from colleagues in ecuador (led by co-author jb). we collaborated with member countries to pilot the online course in several countries to ensure its relevance to the local context. during the pilot phase, the participants expressed high levels of satisfaction towards the training specifically the interactive format and comprehensive content. the online course and tools, such as the workplace assessment, have been presented at various regional and national trainings such as the paho train-the-trainer workshops which were held in venezuela, colombia, ecuador, trinidad and tobago and belize. the latin american and south african work also included development of evidence-based training programs to specifically build capacity of health and safety committees, as our previous research indicated was important [ ] . the tools developed have since been revised and are now being used to train health and safety committees in canada as well. advances in worker health and safety have been historically tied to workers' struggles, led usually by trade unions, to obtain better working conditions. the well-being of the workforce, particularly when the economy is strained, as is occurring ever more forcefully in this era of deregulated globalization [ , ] , is often treated as expendable by decision-makers. ironically, perhaps, worker health and safety has not received greater attention in the healthcare sector than in other economic sectors [ ] , despite the fact that health workers constitute the largest workforce in the world, with an estimated million worldwide [ ] . while the tools we produced are limited in conveying an indepth understanding of the complex global forces that weaken public health systems, hindering the allocation of resources to infection control and worker health, they do help mitigate the impact of resource strains in countries such as ecuador and south africa, where strong government commitment has been expressed towards health system improvement and worker well-being. our collaboration has produced a better understanding of the social, cultural, environmental, occupational and economic processes that determine the health of health workers locally [ , , , , [ ] [ ] [ ] and globally [ , , , ] . our conceptual framework has been since used by other research groups [ ] ; our findings were used by hospital decision-makers and government planners; and these research findings were taken into account by our own team in the development of the tools described above. as noted above, the research we conducted first confirmed that providing health workers with training to properly protect themselves from infectious diseases is significantly associated with better perception of a positive safety climate. after we created training tools to address the organizational, environmental and individual factors we identified as important determinants of infection control compliance, we conducted further research followingup on the use of these online tools. we then found that providing time to take the course on work time was significantly associated with higher intention to comply with safety precautions compared to promoting the course on a voluntary basis (logistic regression model showed a statistically significant difference between supervisor-required and voluntary groups with respect to perceived importance of infection control in the workplace, the extent to which the facility ensures patient safety, and the extent to which the facility ensures staff safety) [ ] . this led to the course becoming mandatory in british columbia [ ] . building on the findings of our research in canada, initial work in ecuador, and our pilot study in south africa (for example, poor staff knowledge on recapping of needles as well as the finding that more than half the respondents felt that they were not given guidance as to how to perform their jobs safely [ ] ), we collaborated with government officials in ecuador, south africa and the caribbean to develop guidelines, policies and programmes. we also worked with international agencies to develop new policy guidelines [ ] . acting on our own research findings, we created further training materials, addressing not only basic infection control and how to don and doff personal protective equipment, but how to establish health and safety committees, inspect workplaces, investigate incidents, and establish policies and health and safety programs based on solid evidence. our work has squarely addressed north-south power relations and the digital divide, always building on local capabilities to transfer knowledge south-south, north-south and vice versa in a respectful manner that benefits both northern as well as southern partners [ ] . the products developed have been widely heralded as innovative and important components of "toolkits" used internationally. the tools now used in canada have, in turn, been improved from the collaborative adaptation process for south and central america and south africa. thus this research has resulted in health service approaches, products and policies that are being embraced nationally (e.g. in ecuador, trinidad-tobago and south africa) and internationally (e.g. through international organizations including paho) as well as having canadian impact [ , , ] . the guidelines, research and needs assessment instruments, web-based health information system, and on-line learning modules will continue to have widespread impact well into the future. more importantly, by elucidating the links between worker health and the health of patients, we have begun to show that attending to the health of the healthcare workforce is not only the right thing to do to protect this vulnerable population, but also produces safer healthcare for all. this case thus illustrates the benefits of infection control and occupational health researchers working together and also how canadians and southern partners alike benefit from international collaboration. this case study is really about a partnership of partnerships. first, there was the partnership between canadian occupational health and infection control [ ] [ ] [ ] [ ] [ ] , ] researchers, and simultaneously, a partnership between an inter-disciplinary ecuadorean occupational and environmental health team and canadian counterparts who shared an appreciation of an ecosystem approach to human health [ ] , including its applicability to emerging infectious diseases [ ] . meanwhile, a new partnership was being forged between the combined canadian occupational health and infection control team and their south african counterparts [ ] , brought together by the world health organization (who). finally, with the assistance of paho and later also the who, the various partnerships were brought together, informing each other in what became an integrated international approach to promoting healthy healthcare. knowledge translation experts emphasize the importance of good quality evidence [ ] as well as involving users of the research findings at the earliest stage. thus it was essential that we involved the local healthcare leadership, already established occupational health services as well as health and safety committee members and governmental-based expertise at the outset. in ecuador, the project built on a strong partnership between the university of andina simon bolivar, the university of cuenca, and various other universities and healthcare facilities on one hand, and the various centres at the university of british columbia on the other. having a strong local champion is key to success, and ecuadorean co-author (jb) fulfilled that role. similarly, we chose pelonomi regional hospital in the free state as a research pilot site to support knowledge translation and capacity building, in large part due to the local champion. a major impact of our work to date has been the demonstration of the benefits of close collaboration between infection control and occupational health, which, in most jurisdictions, was weak. the director of the national institute for occupational health in south africa cited our collaboration as a model that should be embraced in south africa. linkages are now being fostered between infection control and occupational health personnel, modeled on the canadian-initiated collaboration; ohasis, or at least some modules from ohasis, is being used by occupational health and infection control professionals and by health and safety committee members in latin america, the caribbean and south africa, as are the interactive online training modules. the full benefits of these innovations will increasingly manifest over time, but the impact on knowledge, attitudes and practices has already begun to be demonstrated [ ] . collaboration requires mutual respect and trust, as well as a shared vision and sense of common mission. we were fortunate that the various partnerships within this partnership-of-partnerships all agreed to an open source, creative commons philosophy, in which none of the products of our work would be commercialized. this viewpoint also maintains that all derivatives must be approved by all members of the collective, which ensures on-going quality improvement and a flexible, yet standardized, and more easily communicated approach. with this sense of common mission, we are confident that the fruits of our collaboration will continue to provide high quality knowledge transfer of best available evidence. our first real challenge was in sustaining engagement of politically active workplace stakeholders, specifically the trade unions. we have had decades of successful experience in this regard [ , , ] , but may have taken for granted that labour union trust would be there. while this was not problematic in our latin american work, a communications breakdown occurred in the south african work, creating a setback. the lesson learned was that trust can never be assumed, and it is well worth taking the time to ensure that all key stakeholders are indeed engaged before the project moves ahead too far. getting process issues right is paramount to success. a second challenge, also stemming from politicallycharged labour relations, was the advent of a major strike in south africa just as we were beginning what was supposed to have been an intensive two-week capacitybuilding effort. the team therefore had to come up with training innovations (including role-play, drawn scenarios, and interactive on-line learning modules [ , , , ] ); with necessity being the mother of invention, the products created were very well-received and will serve the crosscontinental partnerships well for years to come. another important lesson to note is the importance of thinking about scale-up and sustainability from the start. while the ecuadorean pilots were successful, resources are not in place to continue the efforts at the desired intensity. learning from this, before launching the full pilot in south africa, decision-makers (including coauthor ln) started planning for scale-up early, should the pilot prove successful. this required thinking through complexities beyond the pilot, such as who will continue to implement and monitor the model after the pilot has ended, and how should the model be altered in the pilot with such questions in mind. by working closely with the who, the international labour office, the international commission on occupational health, and a world-expert on scaling up [ ] , we are now optimistic that the tools produced will be successfully used not only in local pockets, but on national and international scale. from a funding perspective, the increasingly embraced philosophy of open source [ ] and creative commons licensing [ ] assures that these tools are available without charge. key however, will be the extent to which local (and national) colleagues are indeed comfortable in using the tools and promoting their use locally. also, in the case of information technology that requires maintenance and periodic updating, commitment from authorities (either government or external funders/partners) is needed. the "business model" of using revenue from distribution in high-income countries to fund maintenance and updates globally, is one way that lmics can have their systems maintained and updated without strain on their resources, and assist high income countries to assume their global responsibilities [ ] . finally, it should be stressed that the success of this work has been, and will continue to be, based on frontline support and active engagement of the decisionmakers. this can never be taken for granted. severe acute respiratory syndrome (sars) and health care workers public health communication with frontline clinicians during the first wave of the influenza pandemic understanding "globalization" as a determinant of health determinants: a critical perspective taming the 'brain drain': a challenge for public health systems in southern africa assessing the health implications for healthcare workers of regulatory changes eliminating locally developed occupational exposure limits in favor of tlvs: an evidence-based bipartite approach international air transportation 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freely available for redistribution authors' contributions ay and eab conceived these projects and created the first draft of this manuscript. jb was responsible for the coordination of the projects in ecuador. nl was responsible for the projects in south africa. mcl aided in the coordination of the projects in venezuela and in trinidad and tobago. all authors (ay, eab, jb, nl, mcl, kl and js) helped to write and revise this manuscript. no competing interests to declare. key: cord- - hau yge authors: macintyre, c. raina; chughtai, abrar ahmad; seale, holly; richards, guy a.; davidson, patricia m. title: respiratory protection for healthcare workers treating ebola virus disease (evd): are facemasks sufficient to meet occupational health and safety obligations? date: - - journal: int j nurs stud doi: . /j.ijnurstu. . . sha: doc_id: cord_uid: hau yge nan virus to the zaire ev is % (baize et al., ) . unlike past outbreaks, the current outbreak of evd has not been contained and has resulted in social unrest, breakdown in law and order, shortages of personal protective equipment (ppe) and depletion of the healthcare workforce, with over healthcare workers (hcws) becoming infected and hcw deaths as of th august (world health organization (who), c). the inability to contain this outbreak has been blamed variously on lapses in infection control, shortages of ppe and other supplies, myths and misconceptions about evd, and the fact that it is occurring in large cities rather than small villages. hcws, many of whom are nurses, are on the frontline of the response, and their occupational health and safety is critical to control of the outbreak and maintenance of the health workforce during a crisis. the who, the us centers for disease control ( ) and several other countries recommend surgical masks for hcws treating ebola (centers for disease control and prevention, a-c; world health organization, d-f) whilst other countries (the department of health uk, ) and mé decins sans frontiè res (msf) have recommend the use of respirators (sterk, ) (table ) . we question the recommendations for surgical masks and outline evidence on the use of respiratory protection for hcws, and the issues that must be considered when selecting the most appropriate type of protection. there is ongoing debate and lack of consensus around the use of respiratory protection for hcws for respiratory diseases, including influenza, which is reflected in inconsistencies between policies and guidelines across healthcare organizations and countries (chughtai et al., ) . in the healthcare setting facemasks (medical/surgical masks) are generally used to protect wearers from splashes and sprays of blood or body fluids and to prevent spread of infection from the wearer, while a respirator is intended for respiratory protection (siegel et al., ) . the mode of disease transmission is one factor which influences the selection of facemasks or respirators -for example, facemasks are recommended for infections transmitted through contact and droplets, while respirators are recommended for airborne infections. such guidelines are based on often tenuous theoretical principles informed by limited experimental evidence, given the lack of data drawn from the complex clinical environment. transmission is not fully elucidated for many infections, spread can occur by multiple modes and the relative contribution of each mode may not be precisely quantified. further, host related factors can mediate the severity of the disease. some diseases exclusively transmit through the airborne route in natural setting (e.g. tuberculosis), while other diseases mainly transmit through the droplet or contact modes but short range respiratory aerosols are generated during high risk procedures which increases the risk of infection transmission (roy and milton, ) . for example, the primary mode of influenza transmission is thought to be droplet (reflected in guidelines which largely recommend surgical masks), but there is increasing evidence that it is also spread by shortrange respiratory aerosols (bischoff et al., ; tellier, ) . for severe acute respiratory syndrome (sars), data supported both droplet and airborne transmission (centers for disease control and prevention, a-c; yu et al., ) . airborne precautions have even been recommended for measles and varicella-zoster viruses despite a lack of data (siegel et al., ) . to date, only four randomized controlled clinical trials (rcts) and five papers on the clinical efficacy of facemasks in the healthcare setting have been published (jacobs et al., ; loeb et al., ; macintyre et al., macintyre et al., , macintyre et al., , b . one of these had only subjects (jacobs et al., ) , and one had subjects (loeb et al., ) . the largest rcts conducted (by authors crm, hs and colleagues) on n respirators and masks, with and subjects, respectively, showed a benefit associated with using n respirators and failed to show any benefit of surgical masks (macintyre et al., . in one of the trials, the majority of laboratory confirmed infections were with respiratory syncytial virus and influenza, neither of which are thought to be predominantly airborne . these data support the concept that transmission of viruses is multimodal and caution against dogmatic paradigms about pathogens and their transmission, particularly when the disease in question has a high case-fatality rate and no proven pharmaceutical interventions. respirators are designed for respiratory protection and are indicated for infections transmitted by aerosols (macintyre et al., . however, this is based purely on the fact that they have superior filtration capacity, and can filter smaller particles. the guidelines fail to consider that respirators offer the additional benefit of being fitted, therefore creating a seal around the face. it is also possible that the seal achieved by a respirator may be an additional benefit over and above the superior filtration that they offer. respirators are not regulated by fit however, only on filtration capacity (with filtration of airborne particles being the sole consideration in guidelines), but the seal offered by a respirator adds to the protection when compared to other mask types. the risk of infection with respiratory pathogens increases three-fold during aerosol-generating procedures (agps) such as intubation and mechanical ventilation (macintyre et al., a) . respirators are generally recommended in these situations for diseases that are known to be transmitted though the droplet route such as influenza and sars (chughtai et al., ) , so the fact that they are not recommended more broadly for a disease with a much higher case-fatality rate such as evd, is concerning. the inability to control the west african ebola outbreak has led to debate around the mode of transmission of ev, with some public health agencies suggesting aerosol transmission (murray et al., ) . current evidence suggests that human to human transmission occurs predominantly though direct contact with blood and body secretions, (world health organization (who), a) and this is the basis of the who and the cdc recommendations for facemasks to protect hcws from evd. however, like influenza and sars, there is some evidence of aerosol transmission of evd. in an observational study from the democratic republic of congo, of the evd cases who visited the home of an evd patient, had contact with the infected case while the remaining five had no history of any contact, which points to transmission through some other mode (roels et al., ) . there is some evidence from experimental animal studies that evd can be transmitted without direct contact; however these studies generally do not differentiate between droplet and airborne transmission (dalgard et al., ; jaax et al., ; johnson et al., ) . in one study, six monkeys were divided into three groups and each group was exposed to low-dose or high-dose aerosolized ev and aerosolized uninfected cell culture fluid (control), respectively. all four monkeys exposed to ev developed infection . jaax et al. found that two of three control monkeys caged in the same room as monkeys with evd, m apart, died of evd . studies have also shown that pigs may transmit ev though direct contact or respiratory aerosols (kobinger et al., ) . in one study, monkeys without direct contact contracted ebv from infected pigs in separate enclosures (weingartl et al., ) . it was not clear whether transmission was due to respiratory aerosols or large droplets. the first infection occurred in a monkey caged near the air ventilation system and positive air samples identified through real time polymerase chain reaction (pcr), which raised the possibility of airborne transmission. however, pigs cough and sneeze more than humans and thus have more capacity to generate aerosols. furthermore, in pigs evd mainly affects the lungs while in primates, it mainly affects the gastrointestinal tract and is excreted in the faeces. as with influenza, the transmission characteristics of evd may also change due to temperature and humidity, and it should be noted that the experimental studies on ev transmission were conducted at low temperature and humidity, which might have favoured aerosol transmission. a recent study has shown that nonhuman primate to nonhuman primate transmission is mainly through contact, with airborne transmission being unlikely (alimonti et al., ) . finally it must be emphasized that ev transmission in high-risk situations is not well studied, particularly during agps, in the handling of human remains or exposure to surgical smoke due to new surgical technologies like laser or diathermy. although the cdc does recommend a respirator during agps for evd patients, aerosols may be created in the absence of aerosol-generating procedures. evidence suggests that aerosols from vomitus can transmit norovirus, and sars was likely transmitted via faecal aerosols (barker et al., ; marks et al., ; mckinney et al., ; yu et al., ) . staff contacts of two hcws infected with ebola in , who were treated in south africa, took universal precautions, with respirators used for high-risk procedures, and no further cases occurred in potential contacts (richards et al., ) . the report of this outbreak (by author gar) has been cited in support of the who and cdc guidelines (klompas et al., ) , however in south africa one hcw contracted ebv when using normal surgical attire during placement of a central line in a patient with undiagnosed ebv. this occurred despite no obvious lapse in infection control. in contrast, once ebv had been diagnosed in the hcw, respirators, impermeable one-piece suits and visors were used (according to south african guidelines), and no further infections occurred despite procedures such as intubation, mechanical ventilation, dialysis, central line placement and the insertion of a swan ganz catheter (richards et al., ) . when determining recommendations for the protection of hcws, guidelines should not be based solely on one parameter, the presumed mode of transmission. a riskanalysis approach is required that takes into account all relevant factors which could impact on the occupational health and safety of hcws (fig. ) . the severity of the outcome (case-fatality rate and disease severity) must be considered. any level of uncertainty around modes of transmission must also be evaluated, particularly if the disease has a high case-fatality rate. in addition, the availability of pre-and post-exposure prophylaxis or treatment must be considered. the immune status and co-morbidities in hcws should also be considered, as some hcws may be innately more vulnerable to infection. as the ageing of the nursing workforce occurs in developed countries, there is likely to be a high proportion of hcws with chronic conditions. in this case, facemasks have been recommended for hcws by cdc and who because of the assumption that ev is not transmitted via the airborne route. however, there is uncertainty about transmission, the consequences of evd infection are severe, there is no proven treatment, vaccine or post-exposure prophylaxis. recommending a surgical mask for evd has much more serious implications than for influenza, which has a far lower case-fatality rate and for which there are easily accessible vaccines and antiviral therapy. further, numerous hcws have succumbed to evd during this epidemic, including senior physicians experienced in treating evd and presumably less likely to have suffered lapses in infection control (world health organization, d-f). aside from these factors, it is also important to consider the perspectives of the staff member. in this highly stressful situation, staff members will want to be reassured that they are using the highest level of protection and are not putting themselves and their families/colleagues at risk. this is especially important if the outbreak escalates and additional staff members are required to assist. staff may refuse to treat patients unless they feel adequately protected. we feel the recommendations for masks do not apply risk analysis methods appropriately, and are solely based on the low probability of non-contact modes of ev spread. previous guidance provided by the who and cdc for ''infection control for viral haemorrhagic fevers in the african health care setting'' in were more conservative, with both organizations recommending the preferred use of respirators first line and surgical masks and cloth masks as a last option (centers for disease control, ) . why then, during the worst outbreak of evd in history, with the most virulent ev strain and with hundreds of hcws succumbing to the disease is it considered adequate for them to wear surgical masks? the high case-fatality rate warrants the use of better protection such as a respirator and full body suit with face shield, where it can be provided. there appears to be a double standard in recommendations for laboratory scientists working with ev, who must adhere to the highest level of biocontainment (bsl ) when working with the virus. (centers for disease control and prevention, a-c; department of health and aging australia, ) further, in contrast to hcws, laboratory fig. . factors to consider in making recommendations for respiratory protection of health workers*. *cost, supply and logistics may affect implementation of guidelines, but should not drive recommendations for best practice. workers are exposed to the virus in a highly controlled, sterile environment in which there is less risk of transmission than in the highly unstable, contaminated and unpredictable clinical environment. the perceived inequity inherent in these inconsistent guidelines may also reduce the willingness of hcws to work during an evd outbreak. table shows recommendations of the selected organizations and countries regarding the use of masks/ respirators for evd for hcws and laboratory workers. only the uk and south african guidelines have consistent guidelines for hcws and laboratory scientists, with respirators recommended for confirmed cases of viral haemorrhagic fever (including evd) (department of health, south africa ; superior health council, belgium , the department of health uk, ). among healthcare organizations, only msf recommends respirators for evd, and notably, in contrast to other international agencies including who, no msf worker has developed evd during the west african outbreak (thomson, ) . in conclusion, whilst ev is predominantly spread by contact with blood and body fluids, there is some uncertainty about the potential for aerosol transmission. there is rct evidence for respirators (but not masks) providing protection against non-aerosolised infections, and an abundance of evidence that transmission of pathogens in the clinical setting is rarely unimodal. where uncertainty exists, the precautionary principle (that action to reduce risk should not await scientific certainty) should be invoked and guidelines should be consistent and err on the side of caution. moreover, a clear description of risk should be provided to hcws (jackson et al., ) . given the predominant mode of transmission, every hcw death from ebola is a potentially preventable death. it is highly concerning that a recent commentary suggests hcws do not need a mask at all ''to speak with conscious patients, as long as a distance of - metres is maintained'' (martin-moreno et al., ) . this fails to consider the changeability and unpredictability of the clinical environment and disregards the rights of the hcw. it is also unrealistic to believe a hcw can constantly keep track of their distance from a patient in the hectic acute care setting. we accept that cost, supply and logistics may, in some settings, preclude the use of respirators, but guidelines should outline best practice in the ideal setting, with discussion about contingency plans should the ideal recommendation be unfeasible. importantly, in the absence of sufficient evidence, recommendations should be conservative and estimation of risk considered. recommendations should be developed using a risk analysis framework, with the occupational health and safety of hcws being the primary consideration. cr macintyre has conducted several investigatordriven trials of respirators vs face masks, one of which was funded by an australian research council linkage grant, where the industry partner was m, a manufacturer of ppe. m also provided supplies of surgical masks and respirators for the investigator-driven trials in health workers in china. h seale was also involved in this research as a co-investigator. a chugtai has had filtration testing of masks for his phd thesis conducted by m australia. evaluation of transmission risks associated with in vivo replication of several high containment pathogens in a biosafety level laboratory emergence of zaire ebola virus disease in guinea -preliminary report effects of cleaning and disinfection in reducing the spread of norovirus contamination via environmental surfaces infection prevention and control recommendations for hospitalized patients with known or suspected ebola hemorrhagic fever in u recognizing the biosafety levels centers for disease control and prevention (cdc), c. fact sheet: basic information about sars available at availability, consistency and evidence-base of policies and guidelines on the use of mask and respirator to protect hospital health care workers: a global analysis combined simian hemorrhagic fever and ebola virus infection in cynomolgus monkeys national guidelines for recognition and management of viral haemorrhagic fevers (draft guidelines) available at guidelines for certification of a physical containment level facility -version transmission of ebola virus (zaire strain) to uninfected control monkeys in a biocontainment laboratory infection prevention as ''a show'': a qualitative study of nurses' infection prevention behaviours use of surgical face masks to reduce the incidence of the common cold among health care workers in japan: a randomized controlled trial lethal experimental infections of rhesus monkeys by aerosolized ebola virus ebola fever: reconciling ebola planning with ebola risk in us hospitals replication, pathogenicity, shedding, and transmission of zaire ebola virus in pigs fruit bats as reservoirs of ebola virus surgical mask vs n respirator for preventing influenza among health care workers: a randomized trial a cluster randomized clinical trial comparing fittested and non-fit-tested n respirators to medical masks to prevent respiratory virus infection in health care workers a randomized clinical trial of three options for n respirators and medical masks in health workers quantifying the risk of respiratory infection in healthcare workers performing high-risk procedures efficacy of face masks and respirators in preventing upper respiratory tract bacterial colonization and co-infection in hospital healthcare workers a school outbreak of norwalk-like virus: evidence for airborne transmission is respiratory protection appropriate in the ebola response environmental transmission of sars at amoy gardens facial protective equipment, personnel, and pandemics: impact of the pandemic (h n ) virus on personnel and use of facial protective equipment an outbreak of ebola in uganda interim biosafety guidelines for laboratories handling specimens from patients under investigation for ebola virus disease available at interim guidance -ebola virus disease: infection prevention and control measures for borders, healthcare settings and self-monitoring at home available at unexpected ebola virus in a tertiary setting: clinical and epidemiologic aspects ebola hemorrhagic fever, kikwit, democratic republic of the congo, : risk factors for patients without a reported exposure airborne transmission of communicable infection-the elusive pathway guideline for isolation precautions: preventing transmission of infectious agents in health care settings filovirus haemorrhagic fever guideline practical recommendations to the attention of healthcare professionals and health authorities regarding the identification of and care delivered to suspected or confirmed carriers of highly contagious viruses (of the ebola or marburg type) in the context of an epidemic outbreak in west africa available at: www.shea-online.org/portals/ /pdfs/belgian-guidelines-ebola aerosol transmission of influenza a virus: a review of new studies ebola virus disease (evd) outbreaks in west africa. important information for clinicians in secondary or tertiary care available at: www management of hazard group viral haemorrhagic fevers and similar human infectious diseases of high consequence. advisory committee on dangerous pathogens available at: www ebola & marburg outbreak control guidance manual. version . transmission of ebola virus from pigs to non-human primates. sci. rep. , . world health organization (who), a. ebola and marburg virus disease epidemics: preparedness, alert, control, and evaluation available at ebola virus disease -democratic republic of congo available at unprecedented number of world health organization (who) ebola virus disease update -west africa infection prevention and control guidance for care of patients with suspected or confirmed filovirus haemorrhagic fever in health-care settings evidence of airborne transmission of the severe acute respiratory syndrome virus we acknowledge dr. kathleen harriman, phd, mph, rn, chief, vaccine preventable diseases epidemiology section, immunization branch, california department of public health for comments and reviewing the final manuscript. key: cord- -xb mv authors: lebrun-harris, lydie a.; mendel van alstyne, judith a.; sripipatana, alek title: influenza vaccination among u.s. pediatric patients receiving care from federally funded health centers date: - - journal: vaccine doi: . /j.vaccine. . . sha: doc_id: cord_uid: xb mv introduction: during the – influenza season, vaccination coverage among u.s. children was . %. the purpose of this study was to estimate the prevalence of influenza vaccinations among pediatric patients seen in u.s. health centers, and to explore potential disparities in vaccination coverage among subpopulations. funded by the health resources and services administration (hrsa) within the u.s. department of health and human services, these health centers provide primary and preventive care to underserved and vulnerable individuals and families in order to reduce health disparities based on economic, geographic, or cultural barriers. methods: cross-sectional data, analyzed in , came from the most recent waves of the health center patient survey ( , ). the sample consisted of children ages – years receiving care from hrsa-funded health centers. the outcome of interest was self- or parent-reported receipt of influenza vaccine in the past year. multivariable logistic regression was used to estimate the adjusted prevalence rate ratios for the association between demographic characteristics (age, sex, race/ethnicity, poverty level, urban/rural residence, geographic region), health-related variables (receipt of well-child check-up, asthma diagnosis), and influenza vaccination. results: influenza vaccination coverage among pediatric health center patients increased from . % in to . % in . in the adjusted model for , there were few statistically significant differences in vaccination coverage among subpopulation groups, however american indian/alaska native children had % increased vaccination coverage compared with non-hispanic white children (aprr: . , % ci: . – . ) and children living in the south had % decreased vaccination coverage compared with those living in the northeast (aprr: . , % ci: . – . ). conclusions: influenza vaccination coverage among pediatric health center patients in exceeded the national average (as of – ), and few differences were found among at-risk subpopulations. hrsa-funded health centers are well-positioned to further increase the vaccination rate among children living in underserved communities. vaccinations, extolled as one of the greatest public health achievements of the th century, continue to be a critical tool for mitigating death and disease in the united states (u.s.) and globally. for a single-year birth cohort, it is estimated that routine childhood vaccination prevents nearly million cases of disease in the u.s., including over , deaths [ ] . moreover, avoided morbidity and mortality due to vaccination is estimated to save $ . billion in direct costs and $ . billion in total societal costs over the cohort's lifetime [ ] . despite the remarkable outcomes provided by recommended vaccines they remain underutilized among children, due to barriers to accessing vaccination services, vaccination exemptions, and parental vaccine hesitancy [ ] [ ] [ ] . in the u.s. each fall, the centers for disease control and prevention and the american academy of pediatrics recommend https://doi.org/ . /j.vaccine. . . - x/published by elsevier ltd. seasonal influenza vaccination for everyone six months of age and older, excluding those with medical contraindications [ , ] . and each year, public health departments and primary care providers work to implement this recommendation. historically, underserved populations, such as those living below the federal poverty line, and those who are uninsured or underinsured, have lower seasonal influenza vaccination rates [ ] [ ] [ ] , leaving those individuals and their communities more susceptible to influenza and related complications. young children are at particularly high risk for severe influenza complications [ , ] . estimates from the - influenza season based on the national immunization survey-flu indicate that the childhood influenza vaccination rate was nearly %-an increase of almost percentage points from the - influenza season [ ] . while this marks a positive shift, the coverage rate remains below the national benchmark of % [ ] . health care providers caring for the underserved are uniquely positioned to help prevent seasonal influenza infections through vaccination and to increase community immunity in the areas they serve. health centers funded by the health resources and services administration (hrsa) within the u.s. department of health and human services, under section of the u.s. public health service act [ ] provide high quality, accessible, and affordable primary and preventative health care to underserved and vulnerable populations across the u.s. in order to reduce health disparities based on economic, geographic, or cultural barriers. in , hrsa-funded health centers served over million patients, including over . million children ages through years, which represents one in nine u.s. children [ , ] . health centers operate with a sliding scale fee structure for patients, based on their income level. with over % of patients living at or below % of the federal poverty guideline [ ] , the health center program provides a model of low cost, high quality health care that can contribute to improving utilization of preventative health services including seasonal influenza vaccination [ ] . given the program's reach among children within underserved communities, health centers are cornerstones in promoting public health in general and influenza community immunity in particular [ ] . to date, there have been no studies examining influenza vaccine uptake among patients seen in hrsa-funded health centers. only one previous study, published in , has examined pediatric vaccinations in the context of health centers, however it focused on the childhood immunization schedule rather than seasonal influenza vaccinations. that study found few disparities in childhood immunizations, and the authors hypothesized that enabling services provided by health centers facilitated access to timely vaccinations [ ] . in , the advisory committee for immunization practices (acip) recommended universal seasonal influenza vaccinations among those six months of age and older [ , ] . thus, this study sought to examine the rates of pediatric influenza vaccinations among health center patients before and after the acip recommendation. the current study contributes to the literature by examining, for the first time, the prevalence of influenza vaccine administration among children served by hrsa-funded health centers. the strengths of the study include the use of hrsa datasets which are nationally representative of u.s. individuals who receive primary and preventive care from health centers, as well as the analysis of several sociodemographic characteristics to explore potential disparities in influenza vaccine uptake across pediatric subpopulations in underserved communities. based on previous studies which have documented minimal disparities in health care access and utilization among health centers [ , [ ] [ ] [ ] , we hypothesized that we would find few disparities in pediatric influenza vaccinations in these settings. we conducted secondary analysis of data from the health center patient survey, a nationally representative survey of people who receive care from u.s. health centers funded by hrsa. the survey is conducted periodically (every - years) by hrsa's bureau of primary health care and is designed to capture information on patient sociodemographic characteristics, health conditions, health behaviors, access to and utilization of health care services, and satisfaction with care. survey questions are based on other established national health surveys, including the national health interview survey, national ambulatory medical care survey, medical expenditure panel survey, and national health and nutrition examination survey. sample selection is based on a stratified three-stage random sampling design. first, health center organizations are sampled, stratified by funding stream, size, u.s. census region, urban/rural location, and number of care delivery sites per health center organization. then, up to three care delivery sites per health center organization are sampled. finally, individual patients from each site are sampled. patients are eligible for the survey if they had at least one medical visit to the health center site in the past year. surveys are conducted through computer-assisted personal interviews by trained field interviewers. for children ages and under, parents or other knowledgeable caregivers respond to the survey; children ages and over respond to the survey themselves, after parental/caregiver assent is obtained. the health center patient survey was most recently fielded survey, when a total of , patients were surveyed between october and april . among patients who were screened and determined to be eligible, % completed an interview. the previous fielding was the health center patient survey, which included a total of , patients surveyed between september and december ; in this fielding, % of patients who were screened and deemed eligible completed an interview. institutional review board approval for the original data collections in both and was obtained from research triangle international, the organization that administered the survey on behalf of hrsa. for the current study, conducted in , the analytic sample of pediatric health center patients included , children between the ages of and years from the survey, and children from the survey. we examined receipt of annual influenza vaccine, as assessed by parent-or self-reported responses to two questions. the first question asked about influenza vaccination injection: ''during the past months, {have you/has name} had a flu shot? a flu shot is usually given in the fall and protects against influenza for the flu season. the flu shot is injected in the arm. do not include an influenza vaccine sprayed in the nose." the second question asked about influenza vaccination nasal spray: ''during the past months, {have you/has name} had a flu vaccine sprayed in {your/his/her} [ ] nose by a doctor or other health professional? this vaccine is usually given in the fall and protects against influenza for the flu season." for this study, we combined responses to both questions to create a dichotomous outcome measure to capture the receipt of an annual influenza vaccine (yes vs. no). sociodemographic covariates of interest included patient age, sex, race/ethnicity, family poverty level, urban/rural residence, and u.s. census region. we also included two health-related variables, specifically, receipt of a well-child check-up in the past months and lifetime diagnosis of asthma (an indicator of a highrisk population). we examined the rates of influenza vaccination among pediatric health center patients in versus . we also stratified vaccination rates by age group ( - years, - years, - years) to determine whether rates declined with age, as is found in national trends [ ] . we limited subsequent analyses to the sample of pediatric patients, the most recent year of health center data available, to assess potential disparities in receipt of influenza vaccines among this population after the acip issued its recommendation for universal vaccination. we first examined the distribution of sociodemographic and health characteristics for patients, and conducted bivariate analyses and chi-square tests of independence with design-based f statistics to assess the associations between receipt of influenza vaccine and each of the characteristics of interest. we set statistical significance at p < . , and calculated % confidence intervals for each estimate. finally, we conducted multiple logistic regression to examine the independent associations between each covariate of interest and receipt of an annual influenza vaccine. results are presented as adjusted prevalence rate ratios (prrs), which represent the likelihood that children with specific characteristics of interest received an annual influenza vaccine, relative to other children in meaningful reference groups while holding all other correlates constant. about % of the sample had missing income data, therefore we created a separate category for ''missing income" in order to retain these observations. we conducted all analyses using stata/se, version . , and employed weights based on the survey's sampling design to produce estimates that adjusted for the complex sampling design and were representative of the underlying population. the overall rate of influenza vaccination among pediatric patients seen in hrsa-funded health center increased from % in to % in , a % increase over years (fig. ) . increases in vaccination coverage were seen across all three age groups. the largest relative increase occurred among youth to years, from % in to % in , a % increase ( percentage points). in both and , there was an inverse doseresponse relationship between vaccination and patient age, with the youngest age group ( - years) having the highest rates of vaccination and the oldest age group ( - years) having the lowest rates. in , % of hrsa-funded health center pediatric patients in the analytic sample were between the ages of and years, and another % were between and years, with the remainder between and years (table ). there were slightly more male patients ( %) than female patients. the most common racial/ethnic group among pediatric patients was hispanic ( %), followed by non-hispanic white ( %) and non-hispanic black ( %). about % of the sample lived below the federal poverty level. over % of pediatric patients lived in rural areas, and slightly more lived in the west ( %) and south ( %) compared with the northeast ( %) and the midwest ( %). almost % of children had received a well-child check-up in the past year, and about % had a lifetime diagnosis of asthma. in unadjusted analyses, only two characteristics were associated with receipt of annual influenza vaccination among health center pediatric patients in (table ) . specifically, a larger proportion of children living in urban settings received a influenza vaccine than those living in rural settings ( % vs. %, p = . ). in addition, children living in the northeast and the west had higher rates of influenza vaccination than those living in the south and the midwest (range: %- %, p = . ). there were no statistically significant associations between influenza vaccination and child age, sex, race/ethnicity, federal poverty level, well-child check-up, and asthma diagnosis. after adjusting for all covariates simultaneously in the multiple logistic regression, the association between urban/rural residence and influenza vaccines was no longer statistically significant (table ) . however, children living in the south had a % decreased prevalence of influenza vaccine receipt, compared with those living in the northeast (aprr = . , % ci: . - . ). in addition, american indian/alaska native children had a % increased prevalence of influenza vaccine receipt relative to non-hispanic white children (aprr = . , % ci: . - . ). among u.s. children ages - years receiving care from hrsafunded health centers, there was a percentage point increase in annual influenza vaccinations between (prior to the acip recommendation) and , from % to % of patients. the influenza vaccination rate among this traditionally underserved population exceeded the - rate seen among u.s. children nationally ( %) by almost percentage points. the age-related pattern seen in health center pediatric patients, showing lower vaccination rates with increasing age, was similar to the pattern in the general u.s. population [ ] . several subpopulations of health center patients exceeded the national benchmark of % uptake, including young children (ages - years), american indian/alaska native and hispanic children, and those living under the federal poverty level, in urban locations, and in the northeast and west. one possible explanation for the increased influenza vaccinations among these subgroups is that health centers may deliver childhood vaccines through the federal vaccines for children program, which provides free or low-cost vaccines for uninsured, underinsured, and medicaid-insured children, as well as american indian/alaska native children [ ] . another potential explanation is that hrsa implemented new activities during this timeframe to promote continuous quality improvement among its grantees, including publicly disseminating clinical performance data and implementing a pay-for-performance program [ ] . additional studies are needed to assess potential differential impacts of these quality improvement efforts on specific subpopulations. although these results demonstrate a vast improvement in influenza vaccinations among this population within a -year span, there is a continuing need to further increase vaccination rates. plans-rubió's ( ) study of community immunity against influenza viruses suggests that % vaccination coverage is required in healthy persons (and % in high-risk persons) to establish a sufficient network of protection in the u.s [ ] . results of this study indicate that hrsa-funded health centers are effectively providing equitable access to seasonal influenza vaccination to a wide spectrum of medically underserved pediatric patients. health centers have a long history of reducing health care disparities by providing access to primary and preventive care to medically underserved and vulnerable populations [ , [ ] [ ] [ ] . the health center data on influenza vaccinations corroborated this pattern, revealing few disparities with the exception of statistically significant lower rates among pediatric patients in the south ( %, compared with % in the northeast) and significantly higher rates among american indian/alaska native patients ( %, compared with % among non-hispanic white patients). previous studies have identified several institutional factors which may contribute to health centers' ability to provide equitable access to services across a broad range of clinical domains, such as cancer screening, chronic condition management, prenatal care, and well-visit check-ups. these institutional factors include the provision of supportive services (e.g., care coordination, health education, translation, transportation), early and widespread implementation of electronic health records, and recognition as patient-centered medical homes [ , , ] . strengthening access to and quality of primary care broadly through these efforts may translate to increased use of specific services including influenza vaccinations, and fewer missed opportunities for influenza vaccinations. indeed, yue and colleagues ( ) found that adult health center patients who used support services had a percentage point higher likelihood of receiving an influenza vaccine compared with those who did not use support services [ ] . given the demonstrated and potential efficacy of these factors in improving health care provided by health centers, hrsa has invested hundreds of millions of dollars to accelerate and optimize the adoption of health information technology, as well as incentivize the adoption of the patient-centered medical home model of care through its quality improvement awards [ ] . while previous studies have found positive effects of these innovations on access to care, quality of care, and disparities [ , , ] , additional analyses may examine their potential impact specifically on pediatric influenza vaccine uptake. our finding of lower rates of pediatric influenza vaccination among health center patients in the south was consistent with patterns identified using the national immunization survey and the national health interview survey [ , , ] , suggesting opportunities to geographically target interventions and resources to improve the uptake of influenza vaccines in this region. results from this study can be leveraged to inform efforts by hrsafunded primary care associations and health center controlled networks that work with health centers in the south [ , ] . additional research is needed to better understand the underlying factors that lead to lower influenza vaccinations among children seen in health centers in the south. racial/ethnic disparities in childhood influenza vaccination are well established in the literature, although the findings are mixed. studies of young children (under age ) have found that white children have higher vaccination coverage than black or hispanic children [ , ] , while national estimates of all children up to age show that white children have similar vaccination rates to black children and lower rates than hispanic children [ , ] . in contrast, our study found no statistically significant differences between these three racial/ethnic groups among the population of pediatric patients served by hrsa-funded health centers. the lack of disparities found within these settings may be a reflection of the health center program's mission to provide culturally competent, patient-centered, comprehensive primary care regardless of individuals' ability to pay, as well as supportive services that promote access to health care [ ] . in particular, hrsa requires that health centers incorporate cultural competency activities to address the unique needs of the populations they serve. this includes arranging interpretation and translation services for patients with limited english-speaking ability, providing resources and training to staff on delivering culturally sensitive services and bridging cultural differences, and regularly conducting needs assessments to improve service delivery with a particular focus on patient population characteristics that impact health status or health care access/utilization (e.g., social factors, physical environment, cultural/ethnic factors, language needs, housing status). in addition, health centers are directed by governing boards that must be composed of a patient majority; at least % of board members must be patients at the health center and must reflect the population served in terms of demographic factors such as race/ethnicity and gender. we also found that the influenza vaccination rate among american indian/alaska native pediatric health center patients was notably higher than the national average for american indian/alaska native children in - ( % vs. %) [ , ] . researchers using the national health interview survey have also reported higher influenza vaccination coverage among american indian/alaska native children compared with other racial/ethnic groups [ ] , which may reflect clinical recommendations to target vaccination efforts for this subpopulation [ ] . our results showed that about % of pediatric health center patients lived in rural areas, twice the proportion of children living in rural settings in the u.s. in general [ , ] . although rural pediatric patients were less likely to receive influenza vaccinations than urban patients in the unadjusted analysis, there were no differences based on urban/rural status in the adjusted analysis, indicating that health centers are successfully serving areas with lower access to care overall. there are study limitations worth mentioning. first, while the results are generalizable to the population of underserved pediatric patients seen in hrsa-funded health centers, they are not representative of the general u.s. child population. although the findings apply only to a specific subgroup, they represent . million u.s. children ages and under, a not insignificant number. second, because the health center patient survey includes patients of all ages, the sample of pediatric patients is relatively limited, and the small sample sizes for certain subgroups may have limited our ability to detect statistically significant differences. third, although influenza vaccines are recommended for infants starting at months, it was not possible to examine vaccination among health center patients younger than years because of how age was coded in the dataset; therefore we were unable to obtain estimates of influenza vaccination for this age group. in addition, two influenza vaccine doses are recommended for children months through years in their first vaccination season but the health center patient survey does not ask whether children received or doses or whether it was their first time receiving a vaccine, therefore it was not possible to distinguish between the proportion of children with full versus partial influenza vaccination coverage. another limitation is potential recall bias. specifically, parents may not accurately remember details of their child's influenza vaccinations, and children years and over who respond for themselves on the survey may be less reliable in reporting their health care utilization in general and in particular may be less aware that they received an influenza vaccine. under these circumstances, our study may underestimate the prevalence of annual influenza vaccination. additionally, the survey includes limited parental or household information, such as parents' education level or health literacy, so it was not possible to assess the association between several potentially relevant family characteristics and pediatric patients' influenza vaccine uptake. in particular, children ages and over were not asked about their health insurance coverage, so we were unable to examine influenza vaccination rates based on insurance status. however, previous research has cited a positive correlation between state-level medicaid reimbursement and influenza vaccination rates among poor children across three separate influenza seasons [ ] , which may be particularly relevant for improving vaccination rates among health center patients, given that nearly half are medicaid or chip beneficiaries [ ] . similarly, the study did not examine the role of knowledge, attitudes, and practices toward vaccines among parents of pediatric health center patients, which might influence the decision to obtain influenza vaccinations. recent literature illustrates that parental concerns about seasonal influenza vaccine exist, including beliefs that the vaccine causes influenza illness, the vaccine is unnecessary because influenza illness is mild, and the vaccine is not effective [ ] [ ] [ ] [ ] . beyond concerns specific to influenza vaccine, more generalized concerns may influence decisions to vaccinate. concerns over safety and vaccine ingredients, number of vaccines administered, mistrust of the mainstream medical system, and the belief that vaccination should be a personal choice persist, and are often shaped by a parent's social sphere of influence [ ] [ ] [ ] [ ] . finally, the health center patient survey was last conducted in - , so the data are now several years old. however, examining the data is still informative in terms of comparing to national averages and providing a baseline for comparing pediatric influenza vaccine rates in the future. the next wave of the survey is planned to be conducted in summer/fall of , which will provide valuable information to ascertain whether hrsa-funded health centers have continued to increase influenza vaccine uptake among their pediatric patients, and to examine any current disparities impacting subpopulations of interest. furthermore, future research should use these anticipated data to examine how the covid- pandemic may impact patients' perceptions of vaccines and influence vaccine uptake. additional research is needed to further explore patient, family, provider, and organizational factors that may influence influenza vaccination among children receiving care at hrsa-funded health centers. notwithstanding the limitations mentioned above, this study provides the first nationally representative estimates of influenza vaccination rates among pediatric patients receiving care from hrsa-funded health centers, both overall and for subpopulations based on demographic and health-related factors. results reveal opportunities to increase pediatric influenza vaccination in health centers so that all subpopulations can attain and surpass the national benchmark of % coverage. possible strategies to improve influenza vaccine coverage include partnering with state and regional primary care associations, which are tasked with providing programmatic, clinical, and financial training and technical assistance to safety-net providers, to support health centers in developing immunization strategies tailored to their localized communities [ ] . additionally, health information technology can be used to better facilitate important vaccine conversations, including patient and provider reminders and prompts in electronic health record systems and patient portals [ ] [ ] [ ] . other potential vehicles for improvement include parent education, proactive appointment scheduling, and strong provider recommendations [ , ] . findings suggest that hrsa-funded health centers can serve as critical providers in engaging and serving diverse constituencies, reducing disparities in influenza vaccination, and increasing immunity among the nation's most underserved communities. the authors have no financial disclosures. the views expressed in this article are those of the authors and do not necessarily reflect the official policies of the us department of health and human services or the health resources and services administration, nor does mention of the department or agency names imply endorsement by the us government. simply put: vaccination saves lives economic evaluation of the routine childhood immunization program in the united states vaccination coverage among children aged - months -united states vaccination coverage for selected vaccines and exemption rates among children in kindergarten -united states, - school year department of health and human services office of disease prevention and health promotion. healthy people midcourse review prevention and control of seasonal influenza with 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states and counties, and for cities and towns with a population of , or more herd immunity: history, theory, practice immunization coverage of vulnerable children: a comparison of health center and national rates prevention and control of influenza with vaccines: recommendations of the advisory committee on immunization practices (acip), . mmwr recommendations and reports : morbidity and mortality weekly report recommendations and reports vaccine timeline: historic dates and events related to vaccines and immunization reducing disparities in access to primary care and patient satisfaction with care: the role of health centers access to oral health care: the role of federally qualified health centers in addressing disparities and expanding access access to mental health services among patients at health centers and factors associated with unmet needs the association of patient-centered medical home designation with quality of care of hrsa-funded health centers: a longitudinal analysis of - flu vaccination coverage, united states, - influenza season cdc. estimates of flu vaccination coverage among children -united states, - flu season. flu vax view vaccines for children program (vfc) health resources and services administration bureau of primary health care the vaccination coverage required to establish herd immunity against influenza viruses enabling services improve access to care, preventive services, and satisfaction among health center patients organizational factors associated with disparities in cervical and colorectal cancer screening rates in community health centers centers for disease control and prevention national center for immunization and respiratory diseases. early-season flu vaccination coverage-united states influenza vaccination coverage among us children from health resources and services administration bureau of primary health care. primary care associations health resources and services administration bureau of primary health care racial disparities in vaccination for seasonal influenza in early childhood complete influenza vaccination trends for children six to twenty-three months health resources and services administration bureau of primary health care. what is a health center new census data show differences between urban and rural populations number of children key facts about the number of children how to improve influenza vaccination rates in the u.s. j prevent med public health = yebang uihakhoe chi flu-floppers": factors influencing families' fickle flu vaccination patterns vaccine hesitancy and influenza beliefs among parents of children requiring a second dose of influenza vaccine in a season: an american academy of pediatrics (aap) pediatric research in office settings (pros) study partnering with parents to remove barriers and improve influenza immunization rates for young children an assessment of parental knowledge, attitudes, and beliefs regarding influenza vaccination what is 'confidence' and what could affect it?: a qualitative study of mothers who are hesitant about vaccines mott children's hospital. national poll on children's health. mott poll report: do parents have selective hearing about flu vaccine for children vaccine safety: myths and misinformation factors influencing african-american mothers' concerns about immunization safety: a summary of focus group findings association between patient reminders and influenza vaccination status among children using reminder/recall systems to improve influenza immunization rates in children with asthma the impacts of email reminder/recall on adolescent influenza vaccination association between provider recommendation and influenza vaccination status among children the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. supplementary data to this article can be found online at https://doi.org/ . /j.vaccine. . . . key: cord- -hdqa es authors: wei, b.; lu, l.; zhang, z.y.; ma, z.y. title: bridging the gap between education and practice in public health, with particular reference to less-developed provinces in china date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: hdqa es ongoing healthcare system reform is one of the most important issues in china. there is an increasing awareness that public health education should be reformed to meet the demands of public health practice. this paper summarizes the current status of increasing public healthcare demand and public health service capacity in china, especially in less-developed provinces, and introduces the current public health educational system and public health administration structure. the paper also provides evidence for a considerable gap between public health education and practice, and suggests possible measures to bridge the gap. china is confronting many new challenges in public health, such as the increasing burden of chronic non-communicable diseases, responding to public health emergencies, mental health problems, injury, an ageing population and environmental pollution. alongside this, infectious disease remains a serious problem, especially in the less-developed provinces of china, such as guangxi and yunnan. both provinces are located in southern china, have a warm climate, many ethnic minority groups and a lower level of social and economic development. for example, the prevalence rates of human immunodeficiency virus/acquired immunodeficiency syndrome (hiv/aids) in yunnan and guangxi provinces are highest and second highest in china. the incidence rates of some infectious diseases, such as hiv and tuberculosis, are much higher than those in more-developed provinces, and pose a serious threat to the health and social stability of these areas. additionally, both provinces are bordered by other countries of south-east asia including vietnam, laos and burma. co-operation with these countries in order to prevent and control new and re-emerging infectious diseases, such as avian flu, h n flu and hiv/aids, is an important part of the health strategies of the two provinces. , additionally, an inverse care law is in operation. the lessdeveloped provinces in china face much greater public health problems than the more-developed provinces, but there are fewer public health professionals available to respond. demand for services is high and this is likely to increase as increasing health awareness (known in china as the 'healthoriented principle') is being increasingly filtered into the population mindset. this, in turn, will increase demand for public health professionals. it has been recognized that there are insufficient qualified, capable public health workers in the centres for disease control and prevention (cdcs) and other public health organizations, particularly in less-developed provinces. this is partly a result of the gap between education and practice in public health, , with a need to develop capacity in the public health workforce for disease control and health protection, and also to ensure that health systems deliver effective healthcare. china is currently reforming its healthcare system. the latest iteration of the direction for the reform has emphasized the importance of the public health system as one of the four essential elements of a basic universal healthcare system. alongside this, in , the institute for international medical education proposed the global minimum essential requirements in medical education, which includes seven core competencies for medical students. consequently, the public health education system in china faces challenges from both recent internal healthcare reform and international public health trends for education and workforce development. the current system and structure of public health education in china remain largely based on the soviet model, which has been in operation since the s. , , schools of public health, which were mainly developed from the former departments of preventive medicine, are an integral part of medical colleges or medical universities. public health is a medical degree. students who pursue bachelors degrees with a major in preventive medicine or public health need to study at university for years. they need to complete courses in natural science, basic biomedical sciences and clinical medicine in the first years, before moving to study public health professional curricula. public health curricula include epidemiology, health statistics, social medicine and health management, nutrition and food hygiene, occupational hygiene, environmental hygiene, childeadolescent and maternal hygiene, health chemistry and health toxicology. placements, practicums and exercises are conducted in hospitals (clinical training) and cdcs (public health) in the last year of study. a typical school of public health has the following departments: epidemiology and health statistics, social medicine and health management, occupational and environmental health, childeadolescent and maternal health, health toxicology, health chemistry and a teaching laboratory. e the number of staff in schools of public health varies from to , and is generally lower in schools in less-developed areas than those in more-developed areas. for example, there are only staff at the school of public health of guangxi medical university, including teachers, technicians and nine administrative staff. each year, it recruits students majoring in public health and students majoring in health management. over undergraduates and postgraduates have graduated from the school in the past years, most of whom are working in county-level, prefectural-level and provincial-level public health organizations. these statistics are similar to those of the school of public health of kunming medical college. in contrast, peking university school of public health currently has over staff and recruits a total of some undergraduate students each year, which represents % of the number recruited by either the school of public health of guangxi medical university or the school of public health of kunming medical college. peking university school of public health, however, places more emphasis on longer education programmes and postgraduate education, and has more research postgraduate students than the other schools. schools of public health offer a range of academic programmes, which include diploma programmes, certificate programmes and short courses, as well as undergraduate and postgraduate programmes. the -year bachelors degree, masters degree and master of public health (mph) programmes are the most important of these courses. e the masters degree is a science degree that focuses on academic research ability, whereas the mph is a professional degree with a focus on professional knowledge, practice and skills needed in the current practice of public health and health management. public health structures an emphasis on public health and prevention has characterized the health policies in china since the beginning of the s. e since , the ministry of health was established to take responsibility for healthcare policies and activities, including both medical and public health services. healthcare in both rural and urban areas in china is organized through a four-tired service system consisting of national, provincial, municipal (formerly prefectural) and district (in cities) or county (in rural areas) organizations and facilities under the management and supervision of the department of health. at each level of the system, there are hospitals and a cdc. hospitals provide clinical care and cdcs offer preventive and public health services. more recently, in many cities and rural areas, community health centres and clinics have been established to re-inforce primary care, enabling the co-location of primary clinical and public health services. the responsibilities of cdcs include disease surveillance and control, public health emergency response, laboratory analysis and evaluation. a higher-level cdc is also responsible for the public health agenda in its entire region, has an advisory and consultant role for lower-level cdcs in its region, and will provide fieldwork experience and internships for the public health education sector. a cdc must prioritize the scientific research and public health services in the region to achieve measurable health impact for the public, and emphasize prevention of disease by targeting early risk factors and supporting healthy lifestyle behaviours. the role of the cdc in providing leadership to strengthen the health impact of the state and local public health systems is crucial to realizing the vision of optimizing life expectancy and health experience, addressing health p u b l i c h e a l t h ( ) e disparities and supporting equitable health outcomes across the population and life course. one of the duties of the provincial cdc is to provide fieldwork experience and internships for the public health education sector. a typical cdc has functional departments including occupational safety and health, nutrition and food health, infectious diseases surveillance, injury prevention and control, emergency response, health information services, health promotion and vaccination. the number of staff at a cdc varies from to , depending on its tier. there are approximately staff in county centres, e staff in municipal centres and e staff in provincial centres, with various educational and professional qualifications. workers in public health organizations at the district/county level are, in general, a practice-oriented workforce, with a typical qualification being a -year higher diploma. at municipal/prefectural level, most staff have a -year bachelors degree, whilst at the provincial level, a large number of staff have education above bachelors degree, such as a master of science, mph, master of philosophy or doctor of philosophy. in summary, the national cdc and provincial cdcs have many qualified public health professionals, whereas those working in the rural areas tend to have the minimal education necessary to practice. there is a considerable gap between education and practice in public health that has been hindering the further development of public health in china. the most prominent problem is the disconnection between theory and practice. there are several contributory factors. first, schools of public health seem to have an educational goal which is different to that expected by the service sector, and thus the educational objectives may not reflect the needs of public health practice. many schools of public health place more emphasis on producing research-oriented graduates, and pay less attention to the knowledge and skills required in public health practice. it is true that some public health graduates will choose a research career, but most will end up working as a public health practitioner. more diversified educational programmes may be required, and different programmes, such as -, -and -year programmes, master of science programmes and mph programmes, would help to meet different needs but must set clearly different educational objectives. secondly, there is very limited communication between cdcs and the education sector around curriculum development. as a result, many of the basic and essential skills and knowledge required in the cdc, such as the sterilization and disinfection process, are missing in public health curricula. thirdly, many staff move to work in a university immediately after graduation from the university, and fewer and fewer university teachers have first-hand practice experience themselves. as universities are increasingly emphasizing research and paying less attention to teaching, many teachers lack sufficient field experience and practical skills to support their teaching. , for example, in kunming medical college, only seven out of teachers have experience of working in a public health service organization, and have had any practical disease control experience. many teachers responsible for teaching infectious disease have little or no direct experience in the taught areas. few have ever seen a bubonic plague or cholera patient, or participated in dealing with serious public health emergencies such as severe acute respiratory syndrome, h n influenza or avian flu. most of the teachers do not understand the latest national health policies, nor know the requirements of potential employers of their students. many schools place more emphasis on laboratory research than population research, having limited content in the curriculum that can be applied to practical situations, as the former is more likely to produce high-impact publications. fourthly, the number of practice and internship placements for students of schools of public health is limited. the relationship between cdcs and schools of public health is not as close as that between medical schools and affiliated hospitals. in clinical education, students can practice and apply the knowledge and skills immediately after they are taught, whereas such opportunities do not exist for public health students. student learning in schools of public health is further hindered by the old didactic teaching methods which are still the main methods of teaching, and limited opportunities are available for practice, discussion and application. a number of strategies and methods can be applied to bridge the gap between education and practice in public health. these strategies would require greater changes in the education sector than in the service sector, and only the department of education can make most of the changes in the education sector. however, in china, schools of public health are financially and administratively under the department of education, which is independent of the department of health under which cdcs work. communication and collaboration between the education and service sectors in public health would be crucial for any such efforts to succeed. the department of education needs to continuously investigate the new needs and requirements in public health practice, and ensures that education and training in most undergraduate public health education programmes is serviceand practice-oriented and its graduates can gain experience working in grassroots public health institutions. to make this happen, the central and local governments have a role in co-ordinating the education and health departments, and facilitating the exchange of ideas, communication and crosssector collaborations on public health education and practice. ideally, schools of public health and cdcs could be placed under the same department of administration. however, this is unlikely to become possible in the foreseeable future. alternatively, schools of public health and cdcs can be brought together to work more closely in other creative ways. a promising model has emerged in yunnan. the director of yunnan cdc was concurrently appointed as the dean of the school of public health of kunming medical college in . this was the first appointment of its type in china. as p u b l i c h e a l t h ( ) e a result, good communication, fruitful collaborations and a reduction in the educationepractice gap have occurred in the region. for example, senior experienced staff at the provincial cdc have been appointed as adjunct professors to teach at the school, and are able to participate in both teaching and research. conversely, teachers at the school are also appointed as adjunct staff of the provincial cdc, so that they can participate in and observe the service work on the one hand and help with training programmes for the cdc on the other. staff of the two organizations are frequently invited to give lectures and seminars at the opposite institution, and they can also attend each others' lectures and seminars of interest. furthermore, municipal and county cdcs have become members of the teaching base of the school, and municipal and county cdcs have opened their laboratory facilities to the school. these arrangements have extensively widened the opportunities for exposure to real public health work for both teachers and students, and also opened up many new opportunities for collaboration in public health activities across the two sectors. the model for public health education in china needs to be reshaped to reflect the needs and implications of the new biopsychosocial medical model and the ecological model for the determinants of health, , which would entail the development of a multidisciplinary public health workforce, rather than hygiene and disease control technicians. the guiding principle for public health education should be to strengthen students' on-site working capacity, including professional, social and learning capacity. theoretical teaching should adopt the five-in-one method, incorporating lectures, tutorials, self-directed learning, question and answer sessions, and open discussions, alongside a practical aspect, which supports social practice, on-site teaching, seminars and undergraduate mentorship programmes. , today, the term 'public health' is used with a much wider connotation than the old term 'preventive medicine'. most schools in china and worldwide are now called 'schools of public health'. however, in official communications and policy documentations in china, 'preventive medicine' is still used to represent all aspects and areas of public health. this may negatively affect the development of some new public health areas in the schools of public health. at the same time as maintaining public health as a medical degree, efforts should be made to develop multidisciplinary public health, which recognize the contribution to public health from many other disciplines. alongside this, sustaining existing learning opportunities, such as the -year higher diploma and -year bachelors degree, is essential, especially for the less-developed areas in china such as guangxi and yunnan provinces, where there is a need to develop capacity and capability to work at multiple levels of the system, including at grassroots levels. further development of the mph programme, and -and -year courses should be considered to ensure the training of an application-oriented workforce. finally, health education and health promotion courses must be strengthened, to include a practicum in addition to the class hours taught. firsthand experience of epidemiological investigations, health education and health promotion courses are an important tool for cdcs to carry out their routine work. there is a considerable gap between education and practice, particularly in less-developed areas in china. largely due to the administrative disjuncture between the service and education sectors, the major gap is that education is aimed more at theories and research, while the service sector lacks updated knowledge and skills to solve practical problems. creative ways of bringing schools of public health and cdcs together to work more closely are needed to bridge the educationepractice gap. current status, challenges, opportunities and prospect of public health education in yunnan province the origin and prevention of pandemics eight suggestions on public health reform the challenges and opportunities of public health and public health education we are facing today global minimum essential requirements in medical education. institute for international medical education (iime) opinions of contemporary public health education implications of the development of modern public health discussion of public health system and public health education implications of modern public health contents for reforms in public health education in china reflections of public health education reform in china the current state of public health in china discussion on the changes of public health personnel training model in higher education reforming education of preventive medicine and culturing new-type talents of public health the challenges and opportunities in public health education of china centres for disease control and prevention cultivate public health professionals with comprehensive quality at the moment of internship teaching health departments: meeting the challenge of public health education applied topics in the essentials of public health: a skills-based course in a public health certificate program developed to enhance the competency of working health professionals the role of the faculty of public health (medicine) in developing a multidisciplinary public health profession in the uk reform trends of teaching methods on public health education analysis on the reform of public health education methods in china none declared. r e f e r e n c e s key: cord- -cadjzw h authors: ario, alex riolexus; bulage, lilian; kadobera, daniel; kwesiga, benon; kabwama, steven n.; tusiime, patrick; wanyenze, rhoda k. title: uganda public health fellowship program’s contribution to building a resilient and sustainable public health system in uganda date: - - journal: glob health action doi: . / . . sha: doc_id: cord_uid: cadjzw h background: low-income countries with relatively weak-health systems are highly vulnerable to public health threats. effective public health system with a workforce to investigate outbreaks can reduce disease impact on livelihoods and economic development. building effective public health partnerships is critical for sustainability of such a system. uganda has made significant progress in responding to emergencies during the past quarter century, but its public health workforce is still inadequate in number and competency. objectives: to reinforce implementation of priority public health programs in uganda and cultivate core capacities for compliance with international health regulations. methods: to develop a competent workforce to manage epidemics and improve disease surveillance, uganda ministry of health (moh) established an advanced-level field epidemiology training program, called public health fellowship program (phfp); closely modelled after the us cdc’s epidemic intelligence service. phfp is a -year, full-time, non-degree granting program targeting mid-career public health professionals. fellows spend % of their field time in moh placements learning through service delivery and gaining competencies in major domains. results: during – , phfp enrolled fellows, and graduated . fellows were placed in priority areas at moh and completed projects ( outbreaks, refugee assessments, surveillance, and epidemiologic studies, cost analysis and quality improvement); made conference presentations; prepared manuscripts for peer-reviewed publications ( published as of december ); produced moh bulletins, and developed three case studies. projects have resulted in public health interventions with improvements in surveillance systems and disease control. conclusion: during the years of existence, phfp has contributed greatly to improving real-time disease surveillance and outbreak response core capacities. enhanced focus on evidence-based targeted approaches has increased effectiveness in outbreak response and control, and integration of phfp within moh has contributed to building a resilient and sustainable health system in uganda. the burden of communicable and non-communicable diseases (ncds) in uganda is high. most major health outcome indicators fall well short of desired targets: women die for every , live births, and of every , children die before age years. nearly one in three children under years is stunted [ ] . more than half of the disability-adjusted life-years lost in uganda are due to communicable diseases, in part due to the high hiv prevalence ( . %) and tb prevalence ( / ) [ ] . the emergence of multidrug-resistant tuberculosis has spread countrywide, and the growing noncommunicable disease burden is of increasing concern [ , ] as an ecological hotspot, uganda has infectious disease transmission belts for meningitis, yellow fever, and viral haemorrhagic fevers. the country is prone to emerging and re-emerging infectious diseases, most of which have occurred in epidemic proportions in recent times with significant cost implications. for example, the cost of responding and controlling the marburg virus disease outbreak in kween district, eastern uganda was approximately $ million usd [ ] . addressing all of these health challenges requires a resilient health system, if meaningful prevention and control is to be achieved. health system resilience comprises both health system strengthening and sustainability. health system strengthening refers to significant and purposeful efforts to improve the system's performance, while sustainability has been defined as the implementation and continuous use of new practices that are able to produce the intended outcomes over a long period of time [ ] . the world health organisation (who) in developed a framework that describes health system strengthening in terms of six building blocks: service delivery, health workforce, health information systems, access to essential medicines, financing, and leadership/governance [ ] . health workforce challenges have been recognized as a critical bottleneck to the delivery of high-quality health services, including response to epidemics. the spread of ebola in west africa during - was compounded by weak-health systems characterized by lack of public health capacity for outbreak detection and control [ , ] . while there is no doubt that new strategies are needed to respond to evolving systems challenges, even the current available human resources are not being used to sufficiently strengthen the performance of health systems. evidence-informed policy-making presupposes the availability of high quality, relevant information, and decision-makers may need support to assess what is already known or to articulate demands for specific new evidence. field epidemiologists respond to public health emergencies, including outbreaks, as well as conducting epidemiologic research, evaluating and improving surveillance systems, implementing public health programs, and publishing data to facilitate evidence-based decision-making. the shortage of field epidemiologists in uganda to address critical aspects of health in the public sector prompted the uganda ministry of health (moh), with support of key partners including makerere university school of public health (maksph) and us centers for disease control and prevention (cdc), to establish the uganda public health fellowship program (phfp) in . phfp is an in-service, post-master's-degree field epidemiology training program (fetp) that attempts to address human resources for health needs. as part of the moh's long-term sustainability vision, phfp will exist as a directorate and capacity-building arm of the uganda national institute of public health (uniph); uniph is an initiative of the moh to create an integrated disease control centre, analogous to the us cdc. this paper describes the phfp, its development and organization, and its contribution to building a resilient and sustainable health system by training a critical mass of competent field epidemiologists in uganda. the phfp is a -year, non-degree-granting, full-time, competency-based fellowship program modelled after the us cdc's epidemic intelligence service (eis) program. the program is primarily funded by the us government through the president's emergency plan for aids relief (pepfar), the president's malaria initiative (pmi), and the global health security agenda (ghsa). the phfp trains midcareer professionals who have a master's degree (or higher) in a health-related discipline and who aspire to become public health leaders. during the two-year fellowship period, fellows are required to attain certain core competencies in domains that include public health emergency response, surveillance data analysis, surveillance system evaluation, applied epidemiologic study, cost analysis of outbreaks, quality improvement science, burden of disease estimation, and leadership skills. their attainment of these competencies is demonstrated by completing a portfolio of projects in each of these domains. phfp is integrated as an arm of moh, and, together with the integrated epidemiology and surveillance department (iesd), the public health emergency operations centre (pheoc), and other important public health programs in the moh, conducts investigations and studies that provide data for decisionmaking for the national task force (ntf). the ntf is an arm of the moh created to coordinate emergency health response, and is responsible for bringing partners together, providing strategic direction to response, and coordinating functions that contribute to prevention and control of public health emergencies. the phfp secretariat is the operational and administrative unit responsible for coordinating the program. its functions include: (a) coordination of phfp partner collaboration with moh, (b) organizing and supervising fellows' placements within moh, (c) performance review of fellows, (d) back-up mentorship for fellows and coordination of mentorship activities, and (e) development of strategic and operational plans for approval by the phfp steering committee (sc). the phfp secretariat comprises a field coordinator, two field supervisors, a scientific writer, a training manager, and an administrative assistant, based at the ministry of health. the cdc resident advisor, who provides technical and programmatic guidance, supports the secretariat, but is not a part of it. applications are solicited through the print media, the program website, the alumni association, and professional associations. short-listed candidates are required to undergo a rigorous interview process comprising an in-person interview, a power point presentation on a given relevant topic, and an essay on a selected topic. approximately fellows are selected annually. the service-in-training program comprises two didactic courses of approximately six weeks in duration each (~ % of the program time): an introductory course at the beginning, and an advanced course towards the end of the first year. the remaining weeks (~ % of time), the fellows are placed at an moh host site, where they implement activities stipulated in their scope of work and work plans, tailored towards accomplishment of host site activities and fellowship deliverables. the hands-on-learning is anchored around intense continuous mentorship by mentors at the host site, the secretariat, and staff at makerere university college of health sciences. fellows' progress is monitored and performance appraised on a quarterly and annual basis. supportive supervision is offered to the host site to ensure prompt identification of problems and possible solutions. (table ) . graduation: by january , the first three cohorts of fellows had graduated. all graduates have been absorbed within the moh ( %) or are working with moh-affiliated or linked institutions or organisations [who, idi, afenet and africa cdc] ( %) ( table ) . field projects: during the nearly four years of the program implementation, the phfp fellows completed more than applied epidemiology projects, of which were outbreak investigations and were emergency refugee health assessments. in addition, fellows have conducted surveillance projects, including analysis of surveillance data or evaluation of a surveillance system, and completed epidemiological studies, quality improvement projects, and cost analyses for outbreaks (table ) . on average, each fellow implemented projects. these field investigations have been conducted throughout the country (figure ). communication outputs: phfp has submitted manuscripts for publication in peer-reviewed journals; were published as of december . a total of manuscripts are undergoing internal and cdc reviews. findings from some of the published manuscripts, such as risk factors for podoconiosis in kamwenge district, uganda [ ] were widely covered in major national and international media outlets, including international national newspapers have also published articles from many fellows, written to inform the public about current public health challenges, such as outbreaks and tips on disease prevention. these publications have contributed to use of their public health recommendations on a wider scale nationally. contribution to building a resilient system: prior to phfp, there was no investigative arm for outbreak response at moh; the phfp created and now leads this arm, as part of the national rapid response team. outbreak reports prepared by fellows are routinely submitted to the pheoc and presented at the national task force for epidemic preparedness and response, which helps to guide outbreak prevention and control in the country. examples include field projects participated outbreak investigations emergency investigations surveillance applied epidemiologic studies cost analysis of outbreaks quality improvement identification and investigation of a large typhoid outbreak in , which affected over , residents in kampala, in which investigation findings helped to guide the successful control of the outbreak, early identification and investigation of a yellow fever outbreak in , leading to a subsequent mass vaccination campaign by moh, and investigation of a meningitis (serogroup w) outbreak in an institutionalized population in , with subsequent control efforts potentially preventing spread into the civilian population. phfp also provided epidemiologic support for nationwide outbreaks of cholera, malaria, measles and anthrax [ ] . phfp fellows have also conducted emergency assessments and evaluations at several refugee settlement areas. implementation of recommendations from these investigations by moh and un agencies has potentially prevented outbreaks and improved the health of the refugees. the prompt epidemiologic investigations conducted by the phfp have resulted in shortened time to identify dangerous pathogens, and prevented potential spread of outbreaks. for example, due to timely investigation and prompt response, a yellow fever outbreak that occurred in was confirmed within days and controlled within three weeks of the initial outbreak report. in comparison, the previous yellow fever outbreak in uganda in took days to confirm and months to control [ ] . due to its achievements, phfp won the cdc director's award for excellence in public health and response at the eis conference [ ] . phfp and the moh are also supported by a frontline fetp program, established by the moh in partnership with the cdc in . frontline fetp augments disease surveillance and outbreak detection and response at the district level [ ] . in just four years of operation, uganda's public health fellowship program has demonstrated the ability to address multiple gaps in the uganda health system. they have generated quality products, experienced adoption of recommendations from their projects, and received national and international recognition [ ] . as an integrated and adaptive program, phfp has greatly improved uganda's capacity to respond to disease outbreaks and other public health emergencies, controlling them at their sources, in a timely and effective manner. much as established literature guides response to epidemics, we are aware that each outbreak is unique. before phfp, outbreak responses in uganda typically had only minimal epidemiological investigation [ ] . the commencement of phfp brought systematic approaches to epidemiologic investigations in almost all outbreaks in uganda [ ] [ ] [ ] . as a result, phfp has made the national rapid response team more focused and enabled the moh to control outbreaks in a shorter time period and at lower cost. the decisions taken by the national task force are now routinely informed by evidence generated by phfp. vertical moh programs have benefitted from having embedded fellows routinely analyse their data and ensure that alerts are generated promptly. because phfp is non-degree awarding and fellows are required to already have at least a master's degree on entry, fellows spend more time working on program-oriented projects that address national health needs, and less time in didactic courses. this is different from most fetps, in which residents earn degrees while in their programs [ ] . this model allows the fellows to obtain wide range of experience at all levels of public health in uganda. fellows have also demonstrated this capability by producing more manuscripts and presenting a number of papers at national and international level within a short span of time. compared to the evaluation report of the fetp at chennai, tamil nadu, india whose fieldwork led to the production of scientific communications presented at international meetings and to manuscripts accepted in indexed, peer-reviewed journals in seven years. going by this trend, achievement of phfp will definitely be greater than most fetps [ ] . beyond the health benefits to the country, phfp and similar programs almost certainly provide return on investment through early detection, investigation and control of outbreaks, improvement in surveillance system, and provision of urgently needed data for public health programs. the recent ebola outbreak in west africa cost the global community $ . b to respond to and contain and an additional $ . b in gdp loss to guinea, liberia, and sierra leone [ ] . had a fraction of that sum of money been used to build an effective health workforce in west africa for early identification, investigation, and control of outbreaks, both the human and the massive economic toll of the ebola epidemic could perhaps have been averted. the importance of putting people at the centre of delivery of health services was apparent during the initial response, the early recovery phase, and long-term planning for resilience in the ebola response [ ] . other recent outbreaks, including the middle east respiratory syndrome coronavirus and the zika virus outbreaks, have similarly underscored the need for strong, resilient public health systems to both address the outbreaks and implement containment measures. all fellows who have graduated have been absorbed either within moh or are employed by institutions that work closely with the moh. because the program secretariat and most host sites are in the moh, having graduates working in the different programs within the moh provides opportunity for mentorship of new fellows (table ). increased retention of graduates within the ugandan government will facilitate sustainability of the program. presently, recruitment in ministry of health is the prerogative of the health service commission which derives its mandate from public service regulations. these regulations in its current form does not ring fence any positions for fetp graduates, however, discussion are on the table by all relevant stakeholders to incorporate a clause that will make it easier to recruit and retain fetp graduates in public service. it's important to note that government of uganda (gou) intends to have field epidemiologists trained to match the current population based on the who target of epidemiologist per , population. based on the recruitment of fellows per year and the current reliance on donor funding, it will definitely take a relatively long time to bridge this gap. however, gou's plan to have a fully functional uniph which is largely funded by government in the very near future will definitely help in addressing this challenge. in addition, makerere school of public health has produced fetp graduates since inception in . although phfp has made strides in contributing to building a resilient system, there are still some challenges. the use of evidence generated for disease prevention and control is still limited, partially due to the multiple layers of implementation existing in the ugandan system. even when evidence is available, poor dissemination, rigid mindset, poor coordination of partners, and inadequate resources may hamper its utilization. improved stakeholder engagement with the moh should be able to address this challenge in the long run. funding also has some challenges: although phfp is currently funded by the usa government, for full integration and institutionalization within the uganda moh system there must be domestic resource allocation to support this program. recognizing this need, moh has made phfp a key component of the proposed uganda national institute of public health (uniph) by designating it as a unique directorate [ ] . once the uniph is formally established by the ugandan parliament, it will become an integrated disease control centre in the country and have diversified funding sources from the government, philanthropists, and the private sector, as well as grants and cooperative agreements from international organisations and foreign governments. phfp is intended to be its capacitybuilding component, which will provide a competent workforce of field epidemiologists and other health professionals to meet the public health needs of the country [ ] . moreover, phfp alumni have formed an association called 'field epidemiologists without borders', which will work closely with uniph to champion some of the institute's objectives to ensure knowledge transfer and the building of a critical mass of field epidemiologists [ ] . during its four years of operation, the phfp has contributed greatly to improving the real-time disease surveillance and outbreak response core capacities of the uganda ministry of health. the enhanced focus on evidence-based targeted approaches has increased effectiveness in outbreak response and control, and the integration of phfp within the moh has contributed to building a resilient and sustainable health system in uganda. highly indebted to dr. bao-ping zhu and dr. julie harris, us centres for disease control and prevention, for technical guidance during the entire implementation period of the program thus far. we would like to thank the african field epidemiology network (afenet) for availing us several opportunities and support to showcase our program contribution to building a resilient and sustainable health system in uganda. i thank all the advanced field epidemiology fellows who have made tremendous contributions to enable the program achieve greater horizons. ara -led the writing process after collecting program data, did analysis, interpretation, drafted and coordinated manuscript writing and wrote the first draft; lb, bk, dk, snk participated in data collection, analysis, writing and revision of many drafts; pt and rkw revisited the first draft critically for key intellectual content, read and gave approval of the final manuscript. no potential conflict of interest was reported by the authors. this an initiative of the uganda ministry of health, a joint program implemented in collaboration with us centers for disease control and prevention and makerere university school of public health. the authors of the paper are staff of the uganda public health fellowship program, who have been granted permission to access data and publish any works that may seem befitting to share with the global world. authority was granted through the office of the director general health services, ministry of health. paper context phfp has contributed greatly to improving the real-time disease surveillance and outbreak response core capacities of the uganda ministry of health within a -year span. the enhanced focus on evidence-based targeted approaches has increased effectiveness in outbreak response and control, and the integration of phfp within the moh has contributed to building a resilient and sustainable health system in uganda. http://orcid.org/ - - - uganda bureau of statistics (ubos) and icf. uganda demographic and health survey : key indicators report. ubos and icf uganda population-based hiv impact assessment looking at non-communicable diseases in uganda through a local lens: an analysis using locally derived data national non-communicable diseases prevention and control policy uganda ministry of health. public health emergency operations centre mvd cost estimate report. uganda ministry of health the path towards healthcare sustainability: the role of organisational commitment world health organization maximizing positive synergies collaborative group. an assessment of interactions between global health initiatives and country health systems ebola in west africa: gaining community trust and confidence advancing the global health security agenda: progress and early impact from u.s. investment. global health security agenda risk factors for podoconiosis: kamwenge district elephantiasis linked to volcanic soils found in uganda volcanic minerals behind mystery elephantiasis outbreak in uganda global health protection and security: experts team up to tackle deadly anthrax across uganda overview, control strategies, and lessons learned in the cdc response to the - ebola epidemic cdc. fetp international night: award recipients frontline field epidemiology training programs as a strategy to improve disease surveillance and response strengthening global health security through africa's first absolute post-master's fellowship program in field epidemiology in uganda cholera outbreak caused by drinking contaminated water from a lakeshore water-collection site a prolonged, community-wide cholera outbreak associated with drinking water contaminated by sewage in kasese district, western uganda outbreak of yellow fever in central and southwestern uganda field epidemiology and laboratory training programs in sub-saharan africa from to : need, the process, and prospects seven years of the field epidemiology training programme (fetp) at chennai, tamil nadu, india: an internal evaluation cost of the ebola epidemic improving the resilience and workforce of health systems for women's, children's, and adolescents' health health sector development plan strategy for uganda national institute of public health constitution of association of field epidemiologists without borders. uganda: fewb we give special thanks to the leadership of the ministry of health for offering the support that has enabled us make these great achievements. we thank the us-cdc for supporting the uganda public health program activities and makerere university school of public health for providing program leadership and management of the funds. we are key: cord- -cdqhs bg authors: sharma, vinita; reina ortiz, miguel; sharma, nandita title: risk and protective factors for adolescent and young adult mental health within the context of covid- : a perspective from nepal date: - - journal: j adolesc health doi: . /j.jadohealth. . . sha: doc_id: cord_uid: cdqhs bg nan the following are some covid- erelated mental health risk factors in nepalese youths: ( ) deficient youth mental health services funding; ( ) social media use; ( ) a suddenly-imposed lockdown; ( ) lack of understanding of lockdown restrictions; ( ) sudden work/student life changes; ( ) abrupt postponement of the secondary education examination (sse); and ( ) exposure to devastating earthquakes in . in nepal, there is insufficient funding of youth mental health services [ ] . underfunded mental health services may lead to increased negative mental health outcomes. access to internet and social media has increased in recent years in nepal. social media use has been correlated with negative mental health outcomes such as stress and depression [ ] . in addition, social media may become a source of health-related information during crises [ ] . youths might not have the capacity to handle the frequency or to analyze the accuracy [ ] of information shared via social media. recency [ ] and sender (i.e., echo chambers [ ] ) of information may play an unbalanced role in assessing credibility, which may lead to misinformation and related stress/ anxiety. the implementation of a lockdown mandate with only a few hours of notice in nepal left people unprepared for a long-term restriction on mobility. in addition, the social distancing and isolation that accompanies long-term lockdowns might be a risk factor for anxiety, mood disorders, and addictive and thought disorders [ ] . working youths cannot continue their work, either because their places of employment are closed or because they lack resources (i.e., computers) at home. for students, engagement in schools, in colleges, and with peers, which is a protective factor against adverse mental health outcomes [ ] , was suddenly interrupted. previous and multiple experiences of nepali "lockdowns" (i.e., strikes or bandha and curfews) may have created a false expectation of "life-as-usual" activities during evenings. conflicting information is associated with higher stress [ ] . misplaced expectations (arguably a type of conflicting information) may lead to anxiety and/or depression if and when authorities enforce the covid- lockdown more strictly. the see, a national examination that is commonly associated with stress/anxiety [ ] , was also postponed just hours before the scheduled time [ ] . this abrupt cancellation and lack of information about see's future course left everyone involved in confusion and stress. nepalese youths experienced negative post- -earthquake mental health outcomes, including post-traumatic stress disorder [ ] . a new emergency/crisis scenario may exacerbate those negative outcomes or generate new ones. post-traumatic stress symptoms have been reported in wuhan in the middle of the covid- outbreak [ ] in addition to adverse covid- mental health outcomes associated with vicarious exposures [ ] . mental health protective factors in nepal may include the following: ( ) cultural acceptance of facemasks; ( ) family structure; ( ) school space repurposing; and ( ) availability of free counseling. facemasks are a common sight in nepalese urban centers due to air pollution [ ] . in the wake of covid- , traditional tailors (suchikar) have been sewing and gifting cloth masks. altogether, these habits/measures may facilitate the implementation of cdc facemasks recommendations [ ] . joint and extended families are common in nepal, which provide youths with a support system. as a result, youths are reconnecting with their family values and cultural identity. increased support from friends and family have been reported in the context of covid- [ ] . school campuses are being used as potential quarantine and food collection sites, instilling a sense of social responsibility and community support that may negate adverse mental health outcomes [ ] . finally, trained counselors and psychologists are offering suggestions and psychological first aid (mostly free) via the internet. covid- pandemic challenges are likely to lead to negative mental health outcomes among youths, especially in nepal. table who. novel coronavirus e china covid- ) and the virus that causes it coronavirus disease (covid- ) pandemic figure . chronological order of events related to risk and protective factors for covid- erelated negative mental health outcomes among adolescents and youths in nepal. a/y ¼ adolescents and youths mhs ¼ mental health services sse ¼ secondary education examination detail/ - - -statement-on-the-second-meeting-of-theinternational-health-regulations-( )-emergency-committee-regardingthe-outbreak-of-novel-coronavirus-( -ncov) available at: https:// www.who.int/dg/speeches/detail/who-director-general-s-opening-remarksat-the-media-briefing-on-covid the outbreak of covid- coronavirus and its impact on global mental health the psychological impact of quarantine and how to reduce it: rapid review of the evidence the government of nepal; ministry of health and population child and adolescent mental health problems in nepal: a scoping review internet addiction in korean adolescents and its relation to depression and suicidal ideation: a questionnaire survey social media as information source: recency of updates and credibility of information rumor propagation is amplified by echo chambers in social media mental health during and after the covid- emergency in italy social and school connectedness in early secondary school as predictors of late teenage substance use, mental health, and academic outcomes the school leaving certificate (slc) examination of nepal: exploring negative consequences notification about postponement of see exams'. the government of nepal earthquake exposures and mental health outcomes in children and adolescents from phulpingdanda village, nepal: a cross-sectional study prevalence and predictors of ptss during covid- outbreak in china hardest-hit areas: gender differences matter vicarious traumatization in the general public, members, and non-members of medical teams aiding in covid- control exposure to airborne particulate matter in kathmandu valley recommendation regarding the use of cloth face coverings, especially in areas of significant communitybased transmission impact of the covid- pandemic on mental health and quality of life among local residents in liaoning province, china: a crosssectional study community context of social resources and adolescent mental health key: cord- -blwrpf authors: sampa, masuda begum; hoque, md. rakibul; islam, rafiqul; nishikitani, mariko; nakashima, naoki; yokota, fumihiko; kikuchi, kimiyo; rahman, md moshiur; shah, faiz; ahmed, ashir title: redesigning portable health clinic platform as a remote healthcare system to tackle covid- pandemic situation in unreached communities date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: blwrpf medical staff carry an inordinate risk of infection from patients, and many doctors, nurses, and other healthcare workers are affected by covid- worldwide. the unreached communities with noncommunicable diseases (ncds) such as chronic cardiovascular, respiratory, endocrine, digestive, or renal diseases became more vulnerable during this pandemic situation. in both cases, remote healthcare systems (rhs) may help minimize the risk of sars-cov- transmission. this study used the who guidelines and design science research (dsr) framework to redesign the portable health clinic (phc), an rhs, for the containment of the spread of covid- as well as proposed corona logic (c-logic) for the main symptoms of covid- . using the distributed service platform of phc, a trained healthcare worker with appropriate testing kits can screen high-risk individuals and can help optimize triage to medical services. phc with its new triage algorithm (c-logic) classifies the patients according to whether the patient needs to move to a clinic for a pcr test. through modified phc service, we can help people to boost their knowledge, attitude (feelings/beliefs), and self-efficacy to execute preventing measures. our initial examination of the suitability of the phc and its associated technologies as a key contributor to public health responses is designed to “flatten the curve”, particularly among unreached high-risk ncd populations in developing countries. theoretically, this study contributes to design science research by introducing a modified healthcare providing model. beginning at the end of , the covid- outbreak was declared a pandemic by who on march [ , ] . the main symptoms of covid- are fever, cough, sore throat, and respiratory complications [ ] . respiratory infections can be transmitted through droplets of different sizes, and according to current evidence, the covid- virus (sars-cov- ) is primarily transmitted between people through respiratory droplets (with a particle size of > - µm) when a person comes in close contact (within m) with someone who has respiratory symptoms [ , ] . moreover, other contact routes, such as the immediate environment around the infected person, may also cause transmission of the virus [ ] . in the case of cluster pneumonia of unknown etiology, health workers are recommended droplet and contact precautions when caring for patients and airborne precautions for aerosol-generating procedures conducted by health workers [ ] . sars-cov- became a pandemic virus due to a multitude of factors such as the early spread of the virus by asymptomatic carriers, uncontrolled social behaviors, and insufficient personal protective equipment (ppe), and both the advanced and developing medical systems appear overwhelmed. public health experts are working at relieving pressure on healthcare facilities so resources can be focused on covid- patients. the crisis is even more threatening for developing countries with large underserved populations. as cases multiply, governments, irrespective of developed and developing countries, restricted "nonessential" services by declaring a state of emergency not due to the fear of contagion but as a procedural protocol in order to contain the virus by mandating social distancing. the bangladesh government imposed a nationwide lockdown since march to curb the spread of the novel coronavirus [ ] . bangladesh with its million inhabitants and a density of people per sq. km is in a great crisis as the outbreak could spread further. in bangladesh, % of people live in rural areas where medical facilities are almost absent. recently, the most serious problems in bangladesh are the lack of personal protective equipment (ppe) for doctors or its low quality as well as too many people staying in close proximity and sick people hiding their symptoms. the situation has become more vulnerable as there are an estimated . healthcare workers (doctors and nurses) available per , people [ ] . as of june , at least , people have been infected [ ] among which more than % are the healthcare workers, whereas . % healthcare workers are affected worldwide [ ] . most private medical facilities in bangladesh are turning away patients with other health issues amid the coronavirus outbreak even though the government has issued a circular threatening of the annulment of their license to operate [ , ] . this has deprived many non-covid- patients of needed treatment, resulting in death from cough, fever, breathing difficulties, and diarrhoea [ ] . older people and people with noncommunicable diseases (ncds) such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer appear to be more vulnerable to becoming severely ill with covid- . the covid- mortality rate in china with the presence of one or more preexisting ncd conditions is represented in table . it shows that almost every fatality is associated with preexisting ncds, while no preexisting medical conditions had a fatality rate of only . %. therefore, preexisting ncd-related illnesses increase the risk of death. according to data from italy, almost % of deaths from covid- were related to preexisting diseases, and of these, hypertension accounted for %. as such, the public health impact of covid- will include a significant number of ncd-associated mortalities. the control strategy of large-scale and prolonged lockdowns is bound to increase the morbidity risk for those living with ncds even more. disrupting regular exercise and monitoring check-ups and adding to mental stress may further undermine immune systems among such patients and impact morbidity and mortality rates. many researchers are focusing on the effect of covid- on mental health [ ] , while there is growing public awareness of the association of ncds with covid- mortality rates, and hence, there is also the need to highlight the negative impact of uncontrolled ncds among populations over the long-term. remote healthcare services (rhs) appear well-suited to this purpose, providing ncd patients in remote locations access to critical monitoring services without increasing risk of infection by visiting a hospital. portable health clinic (phc) services, which is an rhs, have proven efficacy in providing necessary information and preventive measures for people without access to healthcare facilities [ ] [ ] [ ] . phc systems have been developed in a preventive healthcare approach with a special focus on noncommunicable diseases. it appears necessary to modify the strategy-of-use of the phc to better respond to the healthcare management needs of ncd patients in an emergency created by the pandemic, particularly in developing countries. in a lockdown situation, this platform can be effectively used to control and manage patient triage, thus relieving pressure on hospitals and healthcare facilities. challenges of remote healthcare systems during an emergency like disasters, pandemics, etc. implies unique challenges to healthcare delivery [ ] . in the context of developing countries, the scenario of using ehealth technology is completely different, especially for rural people who are typically low health-literate and are more at risk for ncds. nearly every one of the countries affected by covid- has instituted social distancing measures. many, including bangladesh, china, france, india, italy, korea, pakistan, singapore, spain, taiwan, and thailand, have enforced large-scale lockdowns to avoid spikes in cases and to buy time to set up appropriate responses. during such emergencies, rhs platforms assume even greater relevance, especially for ncd patients who may be turned away from hospitals treating acute patients. the real challenge is providing primary care services to ncd patients within the context of social distancing. leveraging the phc and attendants of ehealth technologies already successfully deployed in support of rural and remote patients makes this challenge surmountable [ ] . some previous research already confirms the effectiveness of ehealth in emergency response situations, primarily for urban areas in developed countries. however, healthcare planners agree on the need to monitor ncd patients in rural populations of developing countries in the pandemic situation [ ] . however, some questions remain unanswered: how to redesign rhs such as the phc platform to achieve the goal more effectively in a pandemic situation like covid- ? • how to ensure coverage of underserved rural populations who have comparatively less access to healthcare facilities? • how can the rhs platform like phc be adapted to accommodate emergency response situations like covid- ? therefore, this paper tries to answer the above research questions and presents the process of designing and developing an rhs based on the general requirements to tackle communicable diseases for allowing both covid- patients and non-patients in bangladesh. no previous study to date has examined the scopes of designing and developing an rhs based on the general requirements to facilitate primary screening and triaging covid- and primary healthcare services for preventing covid- and controlling ncds. however, such screening and triaging covid- by an rhs is important for cost-effective check-ups and for reducing the risk of transmission for unreached communities with various needs. extensive research works are conducted only on the hospital information systems to construct the hospital management information system of infectious diseases. to improve the efficiency and level of infectious disease management of the hospital, those research investigate their risk factors, the rules of emergence, and the control measures for infectious disease management [ ] [ ] [ ] . however, a challenge during the pandemic in progress is to identify the determinants underpinning the spatial and temporal patterns of the epidemic for making preventive strategies by the decision-makers [ ] . along with these, health services for reducing transmission and triaging is also a necessity. the provision of effective ehealth services likely enhances patients' own abilities to manage their ncds during the covid- outbreak, especially in places where lack of sanitation or availability of ppe increases the risk of contagion. more importantly, ehealth solutions minimize direct contact between the public and healthcare providers and thus promote social distancing without affecting the strength of patient support [ ] . consultancy over video communications has become useful for the delivery of preventive and consultation services. remote consultancy over phone or video communication has already shown social, technical, and commercial benefits for the management of ncds. the important benefits of telemedicine for the health systems for handling covid- , especially on monitoring, surveillance, and detection and the potential for machine learning and artificial intelligence, have been focused very well in many articles starting from one of the very first ones but an opinion from the patients' side is not reported well yet, though it is of importance to draw attention to the ongoing importance of patient involvement when it comes to urgent ehealth solutions for covid- [ , , ] . during public health emergency like covid- pandemic, the digital infrastructures remain intact and doctors can still be in touch with patients but yet no large-scale telemedicine services for monitoring acute and chronic patients' health status and for allowing continuity of care have been considered in the highly affected countries like italy [ ] . with the importance of ehealth becoming formally recognized, several governments are reinterpreting regulations to enable remote medical services by licensed practitioners. the governments are supplementing healthcare budgets to counter the impact of the pandemic, such as the medicare benefits schedule [ ] and medicare in the united states, expanding the coverage range for the testing and treatment of covid- without subscribers' expense [ ] . this allocation can support a range of ehealth services during the covid- phase, enabling more people to receive healthcare at a significantly lower cost compared to hospital-centric services, including telehealth consultations with general practitioners and specialists. doctors or nurses manning the ehealth service will be able to guide patients over video communication. healthcare systems have had to adapt rapidly to the evolving situation for three main reasons: firstly, there is a need to triage and treat large numbers of patients with respiratory illness [ ] ; secondly, there is a need to protect the healthcare workforce to ensure they can treat the sick [ , ] ; and thirdly, we need to shield the elderly and most vulnerable from becoming infected [ ] . this study used the who guidelines to tackle covid- as a theoretical basis of the designed service to satisfy the general requirements in the service and also followed the information system research (isr) framework to involve the people in the service design and evaluation phase. the guidelines of who explains the key components of required healthcare services for covid- disease. according to who guidelines [ ] [ ] [ ] , the following are the key components of required healthcare services for covid- disease: who recommends screening and isolation of all patients with suspected covid- at the first of point of contact with the health care system, such as outpatients and emergency departments/clinics. early detection of suspected patients allows for the timely initiation of appropriate prevention and control measures [ , ] . isolation is a long-established containment response that is designed to prevent further transmission from an individual suspected of exposure to a contagious disease. suspected infectious individuals not in immediate need of medical attention may be effectively quarantined at home instead of a hospital. in pandemics, it is often impossible to accurately identify cases and carriers of the disease, and hence, the closure of premises such as schools, markets, theatres, etc. are declared to physically limit further transmission. physical contact, direct or indirect, is the most important channel for the transmission of infectious disease. contact tracing involves identifying everyone who may have had exposure to an initial case and tracing it to all possible contacts. the privacy of the patients' needs to be maintained to avoid any sort of discrimination to the patient or his/her family. to design a useful information system-based healthcare service based on the who guidelines, we resorted to following the directions and guidelines as proposed in information system research (isr) framework [ ] . theorizing in design science research (dsr) is different than other types of science. it has two general modes of dsr activity and theorizing: (i) the interior mode, where theorizing is done to formulate a theory for design and action with the prescriptive statement about the way to design the artifact, and (ii) the exterior mode, where analyzing, describing, and predicting are done on what happens to the artifacts in the external environment [ , ] . we designed our phc following the theories of the dsr framework. in phc architecture, all artifacts or medical devices are organized following the prescriptive roles provided by who. a portable health clinic (phc) system (shown in figure ) has been developed as an rhs system for the unreached communities with a special focus on noncommunicable diseases [ , ] . a health worker visits a patient with the phc box to measure vital information and to upload the data with the medical history of the patient to an online server by using the gramhealth client application. the remote doctor gets access to this data and makes a video call to the patient for further verification. finally, the doctor creates an online prescription and preserves it on the online server under the patient's profile. the health worker accesses the system, prints the prescription from the server, and passes it to the patient with detailed explanation instantly. the whole process takes about to min per patient. the phc system introduces a triage system to classify the subjects in four categories, namely, (i) green or healthy, (ii) yellow or suspicious, (iii) orange or affected, and (iv) red or emergent, based on the gradual higher risk status of health. the subjects under orange and red who are primarily diagnosed as in the high-risk zone need a doctor's consultation. phc was initially designed to provide primary health screening services to the unreached community in remote areas. it is time to test its compatibility in emergencies to lessen the mortality and morbidity due to ncds in developing countries. the prevalence of ncds such as diabetes, blood pressure, and chronic diseases may rise due to mental stress, fear, income loss, physical inactivity, and more food consumption and during the lock-down situation at home. in the spread of covid- , people can neither go out for physical exercises such as morning or evening walking nor visit a hospital for ncds during the lockdown situation. this phc system is modified to be used for addressing communicable diseases like covid- . the steps are explained in figure . at first, a potential patient can place a call to the nearby health worker. the health worker can ask questions as per the standard protocol. a patient with a smartphone can fill in a self-check form through the web, which ultimately goes to the nearby community health worker. the health worker checks the data and visits the patient with the phc box for clinical measurements. although the original phc box contains various medical sensors, only covid- -related sensors will be used. these are (i) thermometers (omron) for measuring body temperature; (ii) pulse oximeters (oxi meter) for measuring oxygenation of blood (spo ); (iii) digital blood pressure (bp) machines (a&d) for measuring blood pressure, pulse rate, and arrhythmia; and (iv) glucometers (terumo) for measuring blood glucose in the case of diabetic patients. after taking the measurements, the triage algorithm at the phc client device will run to classify the patient into four categories. table shows the proposed logic set for covid- . the orange and red marked patients will be connected with the remote doctor. the doctor will have a video conversation with the patient for further verification of their status. phc was initially designed to provide primary health screening services to the unreached community in remote areas. it is time to test its compatibility in emergencies to lessen the mortality and morbidity due to ncds in developing countries. the prevalence of ncds such as diabetes, blood pressure, and chronic diseases may rise due to mental stress, fear, income loss, physical inactivity, and more food consumption and during the lock-down situation at home. in the spread of covid- , people can neither go out for physical exercises such as morning or evening walking nor visit a hospital for ncds during the lockdown situation. this phc system is modified to be used for addressing communicable diseases like covid- . the steps are explained in figure . at first, a potential patient can place a call to the nearby health worker. the health worker can ask questions as per the standard protocol. a patient with a smartphone can fill in a self-check form through the web, which ultimately goes to the nearby community health worker. the health worker checks the data and visits the patient with the phc box for clinical measurements. although the original phc box contains various medical sensors, only covid- -related sensors will be used. these are (i) thermometers (omron) for measuring body temperature; (ii) pulse oximeters (oxi meter) for measuring oxygenation of blood (spo ); (iii) digital blood pressure (bp) machines (a&d) for measuring blood pressure, pulse rate, and arrhythmia; and (iv) glucometers (terumo) for measuring blood glucose in the case of diabetic patients. after taking the measurements, the triage algorithm at the phc client device will run to classify the patient into four categories. table shows the proposed logic set for covid- . the orange and red marked patients will be connected with the remote doctor. the doctor will have a video conversation with the patient for further verification of their status. note: " days *" should be replaced by " day" and " days **" should be replaced by " days" for years old or older patients with ncds such as diabetes, heart failure, copd, etc. who are using hemodialysis, immunosuppressants, and anticancer agents. no. , spo is optional. unlike the conventional phc for ncds, the local health worker collects the primary symptoms of a patient through a standard questionnaire. if the patient is identified as a potential patient, the phc covid- box will be sent to the patient's home temporarily together with an operation manual so that they can check themselves under the guidance of the health worker. this will save both parties from infection. now, if a patient is identified as a potential covid- carrier by this primary screening using the triage system, as shown in table , the patient will be immediately advised to see the nearby hospital for further investigation and follow-up as needed. otherwise, the health worker will provide a guideline to stay safe at home. since the community health workers are already known to the patients, patients feel more comfortable and safer under their guidance. the privacy of sensitive information of patients will be protected and secured because it is required by an increasing body of legislative provisions and standards [ ] . table shows the functionalities of a portable health clinic to meet general requirements. the high-risk potential patients are dealt with by the hospital, and they can go under treatment or isolation in hospital or home quarantine as per the result of the polymerase chain reaction (pcr) test. on the other hand, the health worker can also guide the remaining patients if they need home quarantine based on the primary screening. thus, the spread of the highly contaminating covid- can be efficiently controlled with the utilization of local health workers. in phc service policy, the health workers are usually from the respective localities. therefore, they know their communities and are in a position to trace with ease and speed those exposed to direct or indirect contact. since the phc reaches people at their doorstep, only those referred by the doctor online need to go to the hospital. this process helps maintain privacy as well. in its existing functional form, deploying the phc and related rhs technologies for socially distanced populations during a public health emergency, such as the covid- pandemic, is beneficial in reducing the risk of transmission to frontline healthcare professionals. moreover, findings indicate that frontline medical staff experience heightened levels of stress when coming into direct contact with covid- patients. the impact of stress on cardiovascular function is well-established experimentally, independent of known risk factors associated with ncds [ ] [ ] [ ] [ ] [ ] . the phc service may create an effective physical separation between the caregiver and the patient without materially diminishing the quality of care or the reliability of care management responses. in bangladesh, medical staffs such as doctors, nurses, and volunteers who are fighting the coronavirus are being socially excluded, driven from the flats or rooms they rent and banned from his or her buildings. official reports from china indicate that . % of the frontline healthcare providers treating covid- patients experience high levels of mental stress. also, . % show signs of depression, . % exhibit anxiety states, and . % suffer from insomnia [ ] . fatalities among healthcare professionals reported from china, korea, pakistan, and the united kingdom may well be causally linked to reduced efficiency as a result of anxiety-induced stress as well as lack of sleep and depressive states [ ] . in japan too, healthcare staff treating the new covid- patients report higher mental stress compared to routine care assignments [ ] . phc and attendant rhs technologies can create the required physical distancing that increases the sense of safety among medical staff and is likely to reduce stress. the most conclusive method for determining covid- infection utilizes pcr techniques, which require running the patients' dna sample through specialized equipment in a laboratory environment. at present, therefore, the remote diagnosis of covid- is not possible. however, the phc can reliably triage individuals presenting with symptoms associated with covid- using a checklist released by the centers for disease control (cdc) [ ] . this way, the phc can help stem the unbridled flow of concerned citizens to healthcare facilities. this reduces the burden on already overextended healthcare staffs and facilities but still allows the concerned citizen to receive reliable well-being information from the phc worker and retains human contact essential to medical care [ ] . while conventional telemedicine applications only offer live contact with a medical professional, the phc system incorporates diagnostic testing for screening ncds and nutritional status. a unique aspect of the phc system is its built-in algorithm that compares up to diagnostic parameters in real-time and generates a triage plan that is relayed to the doctor manning the telemedicine call-point. this eliminates any interference by the phc worker attending the patient by providing the attending doctor with direct control over patient management decisions. phc can reduce the risk of transmission to frontline healthcare workers, can reduce psychosocial stress on frontline healthcare staff, and can optimize healthcare resources for more patients who need them most. as part of its covid- response, the united states congress has promulgated public law no: - , which provides for the temporary removal of restrictions on telehealth services for medicare beneficiaries [ ] . these developments indicate that the phc system can be adapted to regulatory and best practice parameters, either by securing the clinical role of the licensed medical practitioner within the delivery model or by modulating the level of service provision in ways that do not impinge on best practice guidelines. in summary, the phc, even in its present form, can be effectively deployed to eliminate the risk of transmission among frontline healthcare staff and to contribute significantly towards reducing pressure on healthcare services and resources. with considered realignment of its technical configuration, the phc can be deployed as an ancillary resource supporting large-scale public health emergencies, exemplified by the covid- pandemic. the phc system can be effective in providing the following: ( ) a primary-level screening mechanism that can demonstrably reduce the burden of ncd-related complications among covid- patients and that can directly contribute to the reduction of the incidence of ncds by timely advice and treatment; ( ) a primary healthcare service platform for underserved populations in remote regions of developing countries and now mature enough to be adapted to respond to large-scale public health emergencies such as covid- to impact the reduction of associated mortality and morbidities; ( ) a reliable platform for early detection of ncds and associated comorbidities among target populations and for effectively contributing to a tangible reduction in the burden of disease; ( ) a key ancillary mechanism for controlling patient-to-caregiver transmission of covid- by creating physical distance between all except diagnosed cases and attending clinical staff; ( ) evidence for health authorities to choose ehealth technologies, such as a phc service, to provide primary healthcare services simultaneously for covid- and ncds, including video consultation with physicians, preventive health education, and awareness at the grassroots, and to encourage well-being behaviors; ( ) an effective outreach tool for controlling ncds and for decreasing the burden of disease on the target community; ( ) a new approach to responding to large-scale public health emergencies like covid- and to contributing directly to building adaptive resilience among populations at risk. if the paraprofessional worker visiting homes is not well-trained in self-disinfection or access to disinfection facilities is not available between one visit and another, then the contagion can be transmitted by the paraprofessionals. this is indeed what has happened in nursing homes and assisted living facilities across the united states and japan. this may potentially facilitate the spread of the virus rather than containment. however, the main challenge for deploying the phc during large-scale public health emergencies such as covid- is ensuring that the patient is amenable to self-checking, guided by the phc health worker. initial screening requires simple tests for which a manual is provided. health workers can also guide online. another challenge is to ensure access to a facility equipped for a definitive diagnostic test, such as the pcr test in the case of covid- so that the diagnosed patient can be triaged to a hospital for treatment. this paper touched upon relevant current and future public health implications arising from the covid- outbreak. it provided an overview of how several centralized initiatives have emerged to tackle the situation. our initial examination of the suitability of the phc and its associated technologies as a key contributor to public health responses designed to "flatten the curve", particularly among unreached high-risk ncd populations in developing countries, indicates the strong possibility of affirmative impact. in this paper, we redesigned the existing phc for the containment of the spread of covid- as well as proposed corona logic (c-logic) for the main symptoms of covid- , such as fever, cough, sore throat, respiratory complications, etc. through modified phc service, we can help people to boost their knowledge, attitude (feelings/beliefs), and self-efficacy to execute preventative measures. knowledge about covid- means what are the causes, sources of infection, symptoms, ways of transmission, and prevention. as it is a new disease and has become a pandemic within a short period, there is a lack of knowledge, especially among rural people. therefore, it is very important to fill these knowledge gaps timely to prevent and control the spread, which will lead to better practice for prevention and control of the contagious disease. portable health clinics introduce an affordable, usable set of sensors with the transmission facility to convey clinical data to the remote doctor so that the doctor can make an accurate decision. phc with its new triage algorithm (corona logic) classifies the patients on whether the patient needs to move to a clinic for a pcr test. as mentioned in the previous sections, the new model can reduce the risk of transmission and psychological stress on frontline healthcare staff and can optimize healthcare resources for more patients who need them the most. the consultancy service is mostly on introducing nearby hospitals, providing doctor appointments, and interpreting prescriptions. the salient point is that the same model can work in other countries both rural or urban to bring similar benefits for an emergency to reduce the transmission of diseases. therefore, governments and other healthcare sectors can take initiative to use rhss such as the phc service, to provide primary healthcare services simultaneously for triaging susceptible covid- and for supporting ncd patients 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socially stressed heart. insights from studies in rodents study finds psychological burden in frontline medical workers. . available online medical workers face coronavirus mental health crisis from fine to flailing: rapid health declines in covid- patients jar doctors and nurses. the japan times criteria to guide evaluation and laboratory testing for covid- keeping the human touch in medical practice. lippincott williams and wilkins coronavirus preparedness and response supplemental appropriations act this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license acknowledgments: global communication centre in grameen communications provided essential covid- -related information on bangladesh. the authors declare that there is no conflict of interest. key: cord- -f kpug authors: ripp, jonathan; peccoralo, lauren; charney, dennis title: attending to the emotional well-being of the health care workforce in a new york city health system during the covid- pandemic date: - - journal: acad med doi: . /acm. sha: doc_id: cord_uid: f kpug the covid- pandemic has placed an enormous strain on health care workers, and its potential impact has implications for the physical and emotional well-being of the work force. as hospital systems run far over capacity, facing possible shortages of critical care medical resources and personal protective equipment as well as clinician deaths, the psychological stressors necessitate a strong well-being support model for staff. at the mount sinai health system (mshs) in new york city, health care workers have been heroically providing frontline care to covid- patients while facing their own appropriate fears for their personal safety in the setting of contagion. this moral obligation cannot be burdened by unacceptable risks; the health system’s full support is required to address the needs of its workforce. in this invited commentary, the authors describe how an mshs employee, faculty, and trainee crisis support task force—created in early march and composed of behavioral health, human resources, and well-being leaders from across the health system—used a rapid needs assessment model to capture the concerns of the workforce related to the covid- pandemic. the task force identified priority areas central to promoting and maintaining the well-being of the entire mshs workforce during the pandemic: meeting basic daily needs; enhancing communications for delivery of current, reliable, and reassuring messages; and developing robust psychosocial and mental health support options. using a work group strategy, the task force operationalized the rollout of support initiatives for each priority area. attending to the emotional well-being of health care workers has emerged as a central element in the mshs covid- response, which continues to be committed to the physical and emotional needs of a workforce that courageously faces this crisis. the unfolding covid- pandemic and the response of the u.s. health care system has placed an unprecedented strain on the health care workforce. not only have hospitals and health systems needed to dramatically alter workflows and practice settings to protect and treat patients, but they also have had to seek measures to protect the physical health and emotional well-being of frontline workers. physicians, nurses, and other health care workers play critical roles in the response to the pandemic as they detect, contain, and treat serious infectious disease, despite elevated personal risk. as our hospital systems become overwhelmed by the virus-running well over capacity and facing shortages of critical care medical resources, limited availability of personal protective equipment (ppe), and grief over deaths of fellow clinicians-we are observing and anticipating enormous and unabated psychological stressors that necessitate the rapid development and scaling up of a robust model of wellbeing support for staff. with over , employees, the mount sinai health system (mshs) is the largest hospital system in new york city. our city has emerged as the epicenter of covid- cases, and our state has been designated as a major disaster area by the federal emergency management agency. early components of the mshs emergency response have focused on a number of critical areas, including but not limited to addressing staffing, hospital capacity, equipment and ppe procurement, and communications. in addition, as we describe in this invited commentary, we have adopted a central, organized approach to addressing the well-being of the entire mshs employee community. previous epidemics have given some indication as to the sources of psychological stressors we might expect to influence the psychological response of health care professionals working during the covid- crisis. these include the risk and fear of infection and the availability of information. during the - u.s. zika outbreak, access to information and overestimates of contamination predicted diseaserelated anxiety in the general public. this previous experience of the general public is consistent with the current disease-related anxiety of our health care workers who are presently responding to covid- , heroically meeting the obligation to not abandon patients when life and death are on the line and courageously coming to work to provide frontline care. in new york city, the covid- pandemic has required an "all hands on deck" approach. yet in meeting the social contract between health care workers and the public, the moral obligation to treat patients and save lives cannot be burdened by unacceptable risks. it is the absolute responsibility of the medical institution to minimize the risks as much as possible. material support, staff preparation and training, and trust that the leadership cares for staff wellbeing are all critical components for enabling resilience at the institutional and the covid- pandemic has placed an enormous strain on health care workers, and its potential impact has implications for the physical and emotional wellbeing of the work force. as hospital systems run far over capacity, facing possible shortages of critical care medical resources and personal protective equipment as well as clinician deaths, the psychological stressors necessitate a strong well-being support model for staff. at the mount sinai health system (mshs) in new york city, health care workers have been heroically providing frontline care to covid- patients while facing their own appropriate fears for their personal safety in the setting of contagion. this moral obligation cannot be burdened by unacceptable risks; the health system's full support is required to address the needs of its workforce. in this invited commentary, the authors describe how an mshs employee, faculty, and trainee crisis support task force-created in early march and composed of behavioral health, human resources, and wellbeing leaders from across the health system-used a rapid needs assessment model to capture the concerns of the workforce related to the covid- pandemic. the task force identified priority areas central to promoting and maintaining the well-being of the entire mshs workforce during the pandemic: meeting basic daily needs; enhancing communications for delivery of current, reliable, and reassuring messages; and developing robust psychosocial and mental health support options. using a work group strategy, the task force operationalized the rollout of support initiatives for each priority area. attending to the emotional well-being of health care workers has emerged as a central element in the mshs covid- response, which continues to be committed to the physical and emotional needs of a workforce that courageously faces this crisis. individual levels. most important for the individual is sharing with the institution a sense of moral purpose and dedication to caring for the sick. during the extraordinary events associated with a pandemic, feeling highly stressed and fearful is understandable and not a form of pathology. this distress can be reduced by offering peer support, promoting social connections, and enhancing physical safety. health care systems such as ours can play a critical role in allaying fears through procuring critical resources and meeting the basic needs of staff; providing psychosocial and mental health support; and delivering steady, robust, and compassionate communications. using an established infrastructure to promote clinician well-being within the icahn school of medicine in partnership with an existing human resources support model for all mshs employees, we established an employee, faculty, and trainee support task force in early march in response to covid- . this task force, composed of support leaders from across mshs, conducted a rapid needs assessment to capture the concerns of staff. through this effort, the task force identified priority areas believed to be central in promoting and maintaining the well-being of the entire mshs workforce during the pandemic: • meeting the basic needs of the workforce throughout the crisis, • enhancing communications to assist in the delivery of current, reliable, and reassuring messaging that informs the workforce, and • developing a robust array of easily accessible psychosocial and mental health support options. table provides a summary of the work groups, categories of support, and deliverables for each of these priority areas, which we describe below. as the covid- pandemic has taken hold in new york city, we have become aware of the growing concern that the well-being of our health care workers is significantly threatened. when considering well-being in this setting, a central component is meeting basic daily needs, such as housing, food, and personal safety. under typical circumstances, most health care workers are able to meet these needs with relative ease. however, in the current setting, these basic essentials are threatened. foremost on the minds of frontline health care workers working in conditions of possible contagion is personal safety. with the real possibility of insufficient amounts of ppe, such as masks and gowns, health care workers have been expressing increasing concern in their daily work environment. to address this concern, our institution has worked diligently to track down and follow up all potential leads to procure and preserve adequate ppe for staff, while keeping staff updated about ppe supply status. transportation has also become a challenge as public transit and shared rides put health care workers (and the people traveling with them) at risk, but single passenger options are financially unsustainable. our institution has started to offer staff free parking and bike rental options as well as to make arrangements for reduced-cost car rentals. as schools and daycare centers have closed across the city (and tri-state area), childcare for frontline health care workers has also proven a conundrum. the city has opened centers to care for the children of health care workers, and our institution has created a volunteer program to offer childcare to essential clinical staff by linking them with nonessential employees and other resources. in addition, as the disease spreads, our health care workers may need to stay overnight in the hospital or may fall ill, requiring isolation from their families. this has necessitated the identification of additional in-house call rooms and nearby offsite housing. the mshs housing and real estate team has been working internally and with local hotels and institutions to procure accommodations for these scenarios. finally, in busy clinical units with critically ill patients, our clinicians and staff have found it difficult to leave the unit for food. as such, our institution has responded by exploring ways to bring nourishment directly to our hardest-hit units. the sheer magnitude and deluge of information from within and outside our health system has been immense. the mshs crisis communications team quickly developed an effective platform for disseminating information, focusing on both content and delivery. consolidating system-wide messaging into a daily communiqué with links to a comprehensive website has helped streamline messaging and direct our workforce, situated within multiple hospitals and numerous practice sites, to a single regularly updated resource. weekly system-wide virtual town halls have also helped with delivering essential information. messaging has been informed by feedback from a multitude of sources, including the task force, which has made an effort to gather the information needs of all constituents within the workforce, using both anecdotal and structured means of data collection. for frontline providers, for example, concerns around ppe have influenced messaging informing clinicians about efforts to procure such resources. other messaging has addressed the near-universal concerns around resources to meet basic needs. the task force also developed and provided the communications team with "wellness messages," informed by mental health experts, to provide suggestions and tools for managing expected covid- -related anxiety. expressing appreciation and gratitude has been a central component of communiqués, highlighting the heroism of the workforce. in addition, departmental and clinical leaders have been delivering focused and clear messaging to their specific faculty and staff via short, daily, bulleted email updates. they have also been holding daily to weekly conference calls outlining the most critical information. the need for broad expansion of psychosocial and mental health support resources has become evident. at the time of writing, health care workers are working under conditions in which disease case counts are increasing exponentially, concerns are growing that supplies of critical care equipment and ppe are inadequate, and the surrounding city is increasingly under lockdown conditions. while our health system made available and provided numerous psychosocial and mental health support resources before the pandemic (e.g., employee assistance program, psychiatry services, spiritual care), the enormous stress and emotional strain on both clinicians and nonclinical employees has prompted the task force to scale up existing resources and provide additional resources. these include an array of offerings that range from simple self-care resources (e.g., mindfulness activities) to virtual support groups facilitated by social workers and psychologists and to one-on-one counseling sessions and / immediate crisis management. to increase the capacity of existing support and develop new initiatives, trained mental health staff have shifted their responsibilities or volunteered their time to meet these needs. operationalizing these priority areas in a large health system such as ours requires coordination and collaboration of various groups. our task force includes representation from the office of wellbeing and resilience (owbr), human resources, and the employee assistance program, as well as the departments of psychiatry, nursing, social work and others. the task force has used a work group strategy to review and operationalize plans for each of the priority areas (table ). in addition, task force members have maintained close connections with system, hospital, and departmental leaders, as well as with health care workers in the field caring for patients. the owbr's • government/nonprofit crisis lines existing infrastructure of well-being champions embedded within clinical departments and residency training programs has allowed for real-time access to understanding the challenges and concerns of physicians, while nursing and advanced practice provider leaders have captured the needs of their constituentsall in an effort to funnel concerns through the task force to leadership to inform resource allocation and communications. the full impact of the covid- pandemic in new york city remains to be determined. the health care infrastructure and workforce are being put to the test, and working in these conditions is likely to take its toll. we hope that our covid- well-being approach will help us care for our own health care workers and that sharing it will provide insights for other institutions. the moral obligation of health care workers and their contract with society have led to the demonstration of empathic selflessness and a courageous commitment to serve. though the journey forward is uncertain, the bravery exhibited daily by mshs employees, as well as by health care workers across the globe, serves as a beacon lighting the path. trump approves major disaster declaration for new york. hq- - . federal emergency management agency psychological predictors of health anxiety in response to the zika virus clinical review: influenza pandemic-physicians and their obligations the power of moral purpose: sandler o'neill & partners in the aftermath of national child traumatic stress network and national center for ptsd the authors wish to acknowledge, first and foremost, the frontline health care workers within the mount sinai health system for their heroism and bravery in saving lives during the covid- pandemic. they also thank all the leaders within the mshs who have dedicated countless hours to oversee the enormous preparation and operationalization needed to care for the new york city community.funding/support: none reported.other disclosures: none reported. key: cord- -cct cv authors: duplaga, mariusz title: the acceptance of key public health interventions by the polish population is related to health literacy, but not ehealth literacy date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: cct cv background: public health and health promotion rely on many different interventions, which range from health education and communication, through community mobilisation and changes to environmental conditions, to legal and fiscal actions. the introduction of the increased tax on sugar-sweetened beverages (ssb), popularly called sugar tax (st), and a mandatory programme of vaccinations are the strategies inciting the most vivid discussions in polish society. the study was intended to assess the determinants of the attitudes of polish society regarding the st and to vaccinations. methods: for the analysis, the data originating from the survey of a representative adult sample of polish society (n = ) was used. the survey was based on computer-assisted telephone interviewing (cati). the assessment of the relationships between the selected variables and the opinions about the introduction of the st and the safety and effectiveness of vaccinations were carried out using the chi( ) test and univariate logistic regression models. results: the acceptance of the st and vaccination showed a significant relationship to the level of health literacy (hl) but not to ehealth literacy (ehl). respondents having a higher rather than lower hl; older rather than younger; married rather than singles; retired, or on a disability pension, rather than vocationally active and nonusers of the internet rather than users were more likely to show an acceptance for both interventions. those more frequently using health care services and those with chronic diseases showed a greater belief in the safety and effectiveness of vaccinations. conclusions: the relationship between the opinions of the two public health interventions analysed and the sociodemographic variables demonstrated similar patterns. interestingly, the opinions were associated only with hl and not with ehl and users of the internet were more sceptical about the interventions. the concept of health literacy (hl) is of crucial importance for health promotion. the definition of health literacy proposed by the world health organisation (who) belongs to the most popular [ ] . it is clear that a focus on the ability to access and use health-related information is essential, but these are not the only aspects of health literacy. the definition proposed by the who puts the emphasis, not only on the cognitive, but also on social skills. the context of hl is usually associated with the readiness of people to safeguard their health and to manage their contacts with the health care system. there is growing evidence that insufficient hl may be associated with many unfavourable effects. these include displaying unhealthy behaviours [ , ] , lower attention to preventive actions [ ] , lower knowledge about the disease, not following the physician's recommendations and limited understanding of the treatment regimen [ ] [ ] [ ] , worse control of the disease [ ] , and even, a higher risk of hospitalisation and mortality [ ] . some authors also indicated that the lower hl of people is associated with higher expenditure on health care [ ] . the concept of digital hl or ehealth literacy (ehl) is used in parallel. it is related to the accessing, understanding, appraisal and application of health-related information available from digital resources [ ] . considering that the internet is currently one of the primary sources of health information, the role of ehl seems to be obvious; however, the relationship between hl and ehl is not entirely clear. according to norman and skinner, hl is one of the types of literacy needed for developing ehl [ ] . the correlation between both types of literacy, as substantiated in some studies, is at a level of . [ , ] . however, the association between ehl and health behaviours or clinical outcomes is not so well documented as it is for hl. some authors emphasise a broader meaning of hl going beyond the individual context. according to baur, a health literate society should be able to create better public health [ ] . such a perception of health literacy which is a precondition of public health actions, resulted in the call to establish the concept of "public health literacy". according to freedman et al. ( ) , individuals who demonstrate such health literacy, are able to consider and act on health concerns in a community context [ ] . the association between hl and the attitudes to community-or nation-wide public health policies has not been frequently examined. from the onset, health promotion has been proposed as a doctrine combining a whole array of strategies including, not only the development of individual skills, but also the formation of supportive environments, the mobilisation of the community, reorientation of health care services and the shaping of public health policies [ ] . it is evident that health promotion relies on many forms of interventions, even if the role of health education and health communication has been frequently overemphasised. however, it appears that in certain circumstances, educational efforts may provide an inadequate response to public health challenges and governments must, therefore, apply legal and fiscal interventions. in many countries, vaccination programmes are mandatory [ ] . the taxes or duties imposed on alcohol and tobacco products remain one of the most obvious examples of fiscal measures intended to moderate their consumption [ ] . in the last decade, the tax applied to products with a high sugar content became a favoured tool to reduce the harmful effect of sugar-sweetened beverages (ssb) on obesity [ ] . the immunisation schedule requires mandatory vaccinations against tuberculosis, hepatitis b, diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b, pneumococci, measles, mumps and rubella in poland [ ] . the national institute of public health's annual report indicated that depending on the voivodeship, . % to . % of children aged three had been vaccinated against measles, mumps and rubella. however, between and , the number of polish parents who refused to accept the vaccination programmes available to their children has increased significantly, from to , [ ] . this is commonly associated with the influence of antivaccination movements that incite doubts about the safety and effectiveness of vaccines [ ] . in , after a discussion lasting several years, the government prepared legislation for a special tax to be imposed on ssb in response to the growing rates of obesity in polish society. to date, no research has been undertaken to find if hl may be linked to the acceptance of such public health interventions which have triggered significant public debate. the main aim of this study was to assess the association between hl and ehl with the opinions about vaccinations and the introduction of the st held by a representative sample of the adult polish population. the role of other variables, including the utilisation of health care resources, the use of information technologies and the sociodemographic characteristics were also analysed. the analysis was based on the data obtained from a survey carried out on a representative sample of the adult polish population (n = ). the participants of the survey were recruited by the biostat company (biostat sp. z o.o., rybnik, poland) which has extensive experience in conducting opinion polls [ ] . the survey was undertaken using the computer-assisted telephone interviewing (cati) technique and was completed in one week in mid-december . the sample group was selected by the stratified proportional sampling of the database of mobile and stationary phone numbers developed by the biostat company. the survey was carried out with a -item questionnaire, including a -item short version of the health literacy survey questionnaire (hls-eu-q ) [ ] ; an -item polish version of the ehealth literacy scale (pl-eheals) [ , ] and a set of the items asking about the utilisation of health care resources; health status; the use of the internet; opinions on public health interventions and sociodemographic characteristics. more details on the sampling procedure and the structure of the questionnaire is available elsewhere [ ] . statistical analysis was performed with ibm spss v. software (ibm corp. armonk, ny, usa). descriptive statistics were calculated for the variables used in the analysis; absolute and relative frequencies for categorical variables and mean and standard deviation for continuous variables. chi test and univariate logistic regression models were used to assess the association between variables reflecting the opinions about vaccinations and the introduction of the st as well as potential determinants. in the case of continuous variables, the differences between categories were assessed with either the student's t-test or the u mann-whitney test, depending on the distribution of the variable. for independent variables used in the univariate logistic regression models, odds ratio (or) and % confidence intervals ( %) were calculated. the dependent variables used in the logistic regression were developed after dichotomisation of the two items asking respondents for their opinions about ( ) the safety and effectiveness of vaccination, and ( ) the introduction of the sugar tax. the initial responses to these items were ranked on a -point likert scale from "i decidedly agree" to "i decidedly do not agree" with a neutral option in the middle. the responses "i decidedly agree" and "i agree" were coded as " ", other answers as " ". independent variables used in the logistic regression models included the sociodemographic variables (sex, age, level of education, place of residence, net household income, marital status and vocational activity), the utilisation of health care services (visits to health care facilities, hospitalisations), health status (self-assessed health status, the prevalence of chronic diseases), the use of information technologies (it; internet and smartphone use), health literacy (hl) and e-health literacy (ehl). the hl score was calculated according to the guidelines given in the european health literacy survey project [ ] . the total score was calculated only if there were at least meaningful responses to the individual questions. the response options "very difficult" and "difficult "were assigned with value " " and "easy" and "very easy" with value " ". the total score ranged from - [ , ] . the ehl score was calculated as the sum of individual scores after assigning values from to to the response options (from "decidedly not" to "decidedly yes"). the minimum total eheals that could be achieved was and the maximum was . respondents filled the questionnaire anonymously after obtaining the information about the study and confirming they agree to participate. the study was conducted in accordance with the declaration of helsinki, and the protocol was approved by the bioethical committee at jagiellonian university (no. . . . from november , ). the characteristic of the study group is shown in table . its sociodemographic structure corresponds with that of the general population at the same time. the mean age was . ( . ). an hl score could be calculated for the respondents; the mean value (standard deviation, sd) was . ( . ) . the ehl score was calculated only for internet users (n = ) as . ( . ) . furthermore, . % of the respondents were convinced that the introduction of the st was an appropriate measure to reduce obesity in society, . % were undecided and . % did not agree. in turn, . % of respondents believed that vaccines are safe and effective for preventing infectious diseases, . % were unsure, and only . % expressed a negative opinion. the respondents convinced of the safety and effectiveness of vaccinations achieved higher hl scores than those expressing the opposite opinion (mean (sd), . ( . ) vs. . ( . ) , u mann-whitney test, p = . ). in the univariate logistic model, an increase of hl score of one point was associated with a % increase in the probability of a positive opinion (or, % ci: . , . - . ). the opinion was not related to the ehl score (or, % ci: . , . - . ). the results of chi tests and univariate logistic regression modelling for the opinion about vaccination as a dependent variable are presented in table . among sociodemographic variables, there was a significant association between the opinion and age, marital status and vocational status. older respondents were more convinced about the safety and effectiveness of vaccinations (mean age (sd): . ( . ) vs. . ( . ) , student's t-test, p < . ). with every year of age, there was a % increase in positive opinions about vaccinations (or, % ci: . , . - . ). married persons were more than two times more likely to appreciate vaccinations than singles (or, % ci: . , . - . ) and widowed persons, divorced or separated nearly . times (or, % ci: . , . - . ). as for the vocational status, the employees of public or private entities were less likely to have a positive opinion than those on retirement or those receiving a disability pension (or, % ci: . , . - . ) but more likely than university students or pupils (or, % ci: . , . - . ). the analysis based on the chi test has not shown any association between the opinions about vaccinations and the place of residence. nevertheless, the univariate regression model confirmed that respondents living in urban areas with a population of , - , , were less convinced about the safety and effectiveness of vaccinations than those living in rural areas (or, % ci: . , . - . ). the opinion expressed about vaccinations was also associated with the number of visits to health care institutions in the preceding year. those that had to make visits most frequently in the preceding year (at least six or more times) were nearly twice as likely to express a positive opinion about vaccinations (or, % ci: . , . - . ). a positive opinion was also associated with a higher prevalence of chronic diseases and with an unsatisfactory self-assessment of health status. the respondents who suffered from one or more chronic diseases were more inclined to appreciate vaccinations (or, % ci: . , . - . and . , . - . , respectively). the persons who assessed their health status as very good or perfect were nearly % less likely to express a positive opinion than persons unsatisfied with their health (or, % ci: . , . - . ). the users of both the internet and smartphones were less positive about vaccinations (or, % ci: . , . - . and . , . - . ). there was a statistically significant association between the hl score and the attitude towards the introduction of the sugar tax. with an increase of the hl score by one point, the probability of a positive opinion increased by % (or, % ci: . , . - . ; table ). in turn, there was no significant association between the ehl score and this opinion (or, % ci: . , . - . ). the opinion about the st showed a similar pattern of the associations with sociodemographic factors as with the opinions about vaccinations. older persons were more likely to be positive about the st (or, % ci: . , . - . ). singles were less inclined to express a positive opinion than married persons (or, % ci: . , . - . ) widowed, divorced or separated persons (or, % ci: . , . - . ). retired persons, or on a disability pension, were more in favour of the sugar tax than employees (or, % ci: . , . - . ) but students and pupils were less in favour (or, % ci: . , . - . ). there was no association between the variables reflecting the utilisation of health care services and the opinion about the introduction of the st. interestingly, the highest acceptance was shown by the persons assessing their health as satisfactory ( . %) and the lowest by those assessing it as very good or perfect ( . %) or as unsatisfactory ( . %). the univariate regression model showed that there was a significant difference only for the comparison of persons assessing their health as satisfactory and unsatisfactory (or, % ci: . , . - . ). finally, the chi test indicated a significant association both between the opinion about the st and the use of the internet (p = . ) or a smartphone (p = . ). the association was maintained for internet use only in the univariate regression model. internet users less frequently agreed that vaccines are safe and effective (or, % ci: . , . - . ). in poland, the majority of the population ( . %) would appear to believe that vaccination is a safe and effective method of preventing infectious diseases. only . % of the respondents were sceptical about vaccines. however, only % of respondents believed that the introduction of the st was an appropriate measure to limit the prevalence of obesity, but %were of the opposite opinion. the analysis showed that the attitude towards crucial public health interventions depends on a person's level of hl but not on their ehl. furthermore, older persons, married people and the retired or receivers of disability pensions more frequently showed acceptance both for the introduction of the st and vaccinations than, respectively, younger persons, single people and employees. the users of the internet and smartphones were less inclined to accept such interventions as were those who self-assessed their health as very good or perfect. persons with chronic disease or those who declared more frequent visits to health care institutions were more likely to appreciate vaccinations, but not the st. according to the who working group on vaccine hesitancy, there is a very extensive list of determinants of vaccine hesitancy. these may be divided into three domains: firstly influences arising from historical, sociocultural, environmental, health system/institutional economic and political factors; secondly, influences stemming from the personal perception of a vaccine or the social environment, and finally, issues related directly to vaccines and vaccination [ ] . this reported survey was mainly focused on the sociodemographic characteristics, the utilisation of health care services and the use of it. it seems that the general attitude towards vaccination has been rarely researched. eilers et al. have confirmed that the acceptance for several types of vaccines is higher among persons of years and older than among those aged - [ ] . a study carried out in italy showed that vaccine hesitancy was associated with perceived economic hardship and actual refusal with a lower level of parental education [ ] . greater age, receiving information on vaccinations from a physician and the higher quality of such information as well as better knowledge about vaccines were associated with a more positive attitude towards vaccination in a mixed group of polish pupils, students, patients, parents and healthcare professionals [ ] . most studies reporting on the variables related to the opinions of the general public, or specific populations, about vaccinations are focused on particular types of vaccines. novak et al. analysed the data from the national survey of u.s. adults [ ] and assessed the acceptance of influenza vaccination based on actual vaccination rates. they found that the highest rates of acceptance were by non-hispanic whites and blacks and those aged years and older. the systematic review on influenza vaccination in high-income countries carried out by lucyk et al. showed that higher socioeconomic status assessed based on education, income, social class, occupation and the level of deprivation was associated with higher levels of influenza vaccination [ ] . mat et al. published a systematic review of acceptance factors of pneumococcal vaccination among the adult population [ ] . according to these authors, there were three groups of factors influencing acceptance: the provider's domain, patients' perception and sociodemographic factors. in some studies, the group of sociodemographic factors, gender and age were reported to show a significant association with the acceptance of vaccination. higher acceptance was found among women than men and by those aged at least years old. another study performed in the usa, limited to the population of adults aged or above, revealed that the uptake of the pneumococcal vaccine was lower among: those of black and hispanic ethnicity, than among non-hispanic whites; by the poor rather than those with the highest income; among those with a low level of education than among those with at least college education and finally among those living in rural communities or urban inner-city areas, rather than those living in suburban areas [ ] . according to the systematic review published by lopez et al., higher acceptance of human papillomavirus (hpv) vaccine was associated most consistently with female gender and younger age of respondent parent, female gender of the adolescent, higher household income and previous childhood vaccinations [ ] . a recent study by polla et al. revealed that among parents, those who were unmarried were more likely to be hesitant about the importance of hpv vaccination [ ] . the analysis reported in this paper showed that a higher level of hl was reflected in a higher acceptance of vaccinations. consistently, according to the systematic review published by berkman et al. in , low hl was related to a lower probability of accepting influenza immunisations [ ] . however, the results of the systematic review focused on the relationship between hl and attitudes towards various types of vaccinations, published by lorini et al. in [ ] , revealed a more complex picture. the authors included only nine studies in their analysis of respondents representing diverse groups; four studies were undertaken on parents of children who received vaccinations, two among adult citizens, one among adults aged years or more, one among females attending college and one among hispanic females. the studies yielded unequivocal findings, especially in relation to parents' attitudes. in the study performed in israel, higher communicative and critical hl of parents was associated with a greater likelihood of not vaccinating their children [ ] . in the study among dutch parents, all respondents were willing to vaccinate their children against rotavirus when the vaccine was supplied within the national immunization programme, but only by those with lower levels of education and lower hl when the vaccine was to be provided by the free market [ ] . another study, performed in the usa, did not find a significant association between maternal hl and the immunisation status of children [ ] . in the study carried out in india, higher maternal hl was associated with the likelihood of a child receiving the diphtheria-tetanus-pertussis vaccine [ ] . in other groups of respondents, the relation between hl and vaccination uptake varied. higher hl in the usa increased the likelihood of influenza vaccination among older adults [ , ] , and hpv vaccination by undergraduate women [ ] . higher hl was also associated with a higher awareness of hpv and the hpv vaccine by adults in the usa. additionally, in the usa there was no association between the likelihood of influenza vaccination among adult hispanic women [ ] and adults younger than years [ ] . the authors of the systematic review concluded that the role of hl in predicting vaccine hesitancy or acceptance is influenced by various factors including the country, people's age and the type of vaccine [ ] . further studies tend to confirm that the relationship between health literacy and the acceptance of vaccinations is not straightforward and depends on the characteristics of the studied group. in , castro-sanchez et al. found a significant association between hl measured with the short assessment of health literacy for spanish adults and the newest vital sign in pregnant women and the vaccination rates against influenza and pertussis [ ] . women rejecting the influenza vaccine had higher hl. recently, zhang et al. assessed the relation between hl measured with the standard -item version of hls-eu questionnaire and the attitudes towards vaccination in a group of older adults years and greater [ ] . they found that lower competencies related to accessing and appraising health information were associated with more significant problems in reaching decisions about vaccination. the reported study found no significant association between ehl and the acceptance of vaccination, but the use of the internet and smartphones was related to a lower acceptance. the overview of systematic reviews published in by dumit et al. revealed that ehealth interventions and technology might be useful tools for increasing the uptake of immunisations [ ] . however, there are few studies which report on a relationship between ehl and the attitudes towards vaccinations. the research performed by britt et al. on college students, based on the theory of planned behaviour, showed that ehl was positively associated with the intent for hpv vaccination but not with the actual vaccination behaviour [ ] . in a later study in a similar group of respondents from , britt et al. found that ehl was positively associated with beneficial health behaviours identified by the american college health association including seeking for the information on vaccinations and also to a smaller degree, undergoing vaccinations, among college students [ ] . additionally, in aharony and goldman reported that parents refusing to vaccinate their children had a higher perceived ehl than hesitant parents or those accepting vaccinations. additionally, they found that nonrefuser parents had the highest knowledge about vaccinations and the parents refusing vaccinations had the least knowledge [ ] . in , mutur published the results of a survey on ehl and motivators for hpv prevention among young adults in kenya [ ] . she found a positive correlation between ehl and hpv knowledge, perceived risk, self-efficacy and response efficacy. the authors of a systematic review on the association between hl, ehl and health outcomes among patients with long-term conditions found only a few studies in which ehl was assessed [ ] . none were related to vaccination attitudes or practices. currently, ehl as gained new momentum due to the covid- pandemic, but it seems that any high expectations related to its impact on fighting misinformation are yet to be confirmed [ ] . the acceptance of the st has been extensively studied in many countries. in the last decade, surveys carried out in australia showed that about % to % of the population were in favour of the tax imposed on ssb. in , morley et al. reported that % of the surveyed participants were in favour of a tax on ssb [ ] . parents were more likely than nonparents and respondents with a higher socioeconomic status, rather than those with a lower status supported a tax on soft drinks and unhealthy food. in the results of a survey about taxation and nutrition labelling as interventions addressing the incidence of childhood obesity were published [ ] . interestingly, only one-third of respondents strongly supported the introduction of the sugar tax, and % were equivocal about it. the level of acceptance of an ssb tax among parents was related to the household's weekly consumption of soft drinks. in , sainsbury et al. published the results of an online survey on a nationally representative sample of australian adults which found that . % of the participants supported ssb taxation. the binary logistic regression models showed that women more than men, younger rather than older respondents and those with a university degree rather than those who did not complete high school, supported the introduction of the tax [ ] . the acceptance of ssb taxation was also reported by farrell et al. in . according to this team, % of the australian population were in favour of the tax imposed on ssb and that the greatest opposition to the tax was expressed by the most disadvantaged group [ ] . the analysis performed by miller et al. on the data coming from two surveys: a face-to-face survey conducted in and cati survey in , also showed that persons who attained higher levels of education expressed greater support for ssb tax than those with lower levels of education [ ] . the acceptance of a sugar tax was frequently much greater if the tax revenue was to be allocated to obesity prevention, subsidies on healthy food or programmes promoting physical activity [ , ] . in june , belanger-gravel et al. examined separately support for and the perceived effectiveness of public health interventions aimed at the reduction of obesity among - years old respondents resident in quebec, canada [ ] . the introduction of the tax on ssb was strongly supported by . % and somewhat less enthusiastically by a further . % of respondents. . % of respondents assessed this intervention as effective. the survey performed on usa citizens in by rivard et al. , demonstrated that ssb tax was supported by % of respondents [ ] . greater support was expressed by younger respondents, who had attained higher levels of education and those with body mass index (bmi) < kg/m . however, the study published in by gollust et al. showed that the tax as a strategy to reduce the consumption of ssb was supported by only % of adult americans who responded to an online survey [ ] . in , donaldson et al. reported that support for the ssb tax was expressed by % of respondents participating in a telephone-based survey [ ] . the support was related to gender, race, political orientation, ssb consumption but not to age, level of education or annual income. in the study performed by curry et al. on adults in kansas in , support for a tax on ssb was confirmed by % of respondents, and as in the study of donaldson et al. it was higher for women and supporters of the democratic party [ ] . in this study, younger respondents were significantly more supportive than older people. petrescu et al. in two parallel online surveys compared the acceptability of nudging initiatives aimed at tackling obesity in the uk and usa on samples of and respondents, respectively [ ] . taxation intervention was acceptable to . % of respondents from the uk and . % from the usa. in the uk sample, the perceived effectiveness of the intervention was the only significant predictor of the acceptance of taxation. among respondents from the usa, the acceptance was associated with the perceived effectiveness and the belief that the environment is responsible for obesity. a french survey published by julia et al. in showed that an st was perceived as an important measure in improving the health of the population by nearly % of respondents. the support was even higher if the revenues from the tax were to be used for improving the health care system [ ] . contrary to the findings from australia and the usa, greater support was expressed by the older rather than the younger respondents. those who reached higher levels of education were also more supportive. in , kwon et al. reported the results of a multi-country survey (australia, canada, mexico, uk, usa) to assess public support for food policies promoting healthy diets [ ] . they found that taxes on sugary drinks were supported by . % in the usa to . % in mexico. if the revenue raised from the tax were to be spent on subsidising health food, the support would increase considerably to . % in the usa to . % in mexico. an analysis of the determinants in the pooled data from five countries revealed higher support by females than males, older age groups than the youngest groups, and minorities in comparison to the majorities. according to the latest study on public acceptability of an ssb tax in the netherlands, lower acceptability was associated with a lower educational level, being overweight, moderate or high ssb consumptions and living in a household with adolescents [ ] . finally, the systematic review with a meta-analysis based on papers reporting the results of studies, published in by eykelenboom et al., showed that % of the public supported the ssb tax; % accepted it as a measure to reduce obesity, and % supported it if the revenue is used for some type of health-improving initiative [ ] . in poland, contrary to the findings from other countries the sex of respondents was not associated with the acceptance of the sugar tax as a measure to decrease the prevalence of obesity. in many countries, a significant association between age and support for the st was reported. in australia and the usa usually, younger respondents revealed higher acceptance than older people. in surveys performed in other countries, as in poland, older rather than younger respondents were more supportive of the st. finally, in many surveys, again contrary to findings from poland, the level of education was associated with the support for the st. the results of the survey reported in this paper have not shown a relationship between these variables. in surveys carried out in other countries, hl, ehl and internet use were not analysed in respect of the attitude towards sugar taxation. as the penetration of the internet is growing, and in many societies, the number of nonusers is relatively low, many surveys are performed online. therefore, the use of the internet is less frequently considered as a determinant of specific health-related behaviours or attitudes. nonetheless, it may be puzzling why neither hl nor ehl was assessed as a determinant of the acceptance of fiscal interventions to combat the consumption of unhealthy products. it may be related to the fact that hl is still treated more like a construct reflecting an ability to tackle individual health issues than its relevance to the broader public health context. interestingly, among the positive impacts of the introduction of a public health product tax in hungary, an improvement of hl was reported [ ] . there are some limitations of this study which need to be considered. initially, although the sample size is sufficient to reflect general trends in the polish population, it may be too small to clarify the relationships between specific variables. decidedly, further surveys on large samples would be needed to explain the importance of potential determinants of the attitudes towards specific public health measures. furthermore, the survey was undertaken using the technique of cati which may result in less profound consideration of the issues presented in the questionnaire. finally, the survey was performed at the moment when it was not clear that the government was considering the introduction of the st. therefore, for some respondents, the prospect of such a public health intervention could seem very distant, and others would not fully understand its consequences. as for the question about vaccinations, a more targeted approach to the study group probably would be needed as the opinions of parents to the vaccination of their children may be different from the opinions of nonparents or older persons. the survey performed on the polish population showed that there are potentially many variables affecting the opinions regarding the introduction of the st and the safety and effectiveness of vaccinations. apart from the sociodemographic factors like age, marital status or vocational status, the utilisation of health care services, the self-perception of health or the prevalence of chronic diseases as well as the use of it should be considered. interestingly, it transpired that hl, but not ehl, is related 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in a mid-atlantic u.s. state. public health nutr public attitudes and support for a sugar-sweetened beverage tax in america's heartland public acceptability in the uk and usa of nudging to reduce obesity: the example of reducing sugar-sweetened beverages consumption public perception and characteristics related to acceptance of the sugar-sweetened beverage taxation launched in france in a multi-country survey of public support for food policies to promote healthy diets: findings from the international food policy study public acceptability of a sugar-sweetened beverage tax and its associated factors in the netherlands political and public acceptability of a sugar-sweetened beverages tax: a mixed-method systematic review and meta-analysis assessment of the impact of a public health product tax; national institute for food and nutrition science directorate general the author thanks john r. blizzard, a retired uk university senior lecturer, chartered engineer and churchill fellow, for proofreading of the manuscript. the author declares no conflict of interest. key: cord- - opv t p authors: caraccio, chiara; white, robert s; jotwani, rohan title: no protocol and no liability: a call for covid crisis guidelines that protect vulnerable populations date: - - journal: journal of comparative effectiveness research doi: . /cer- - sha: doc_id: cord_uid: opv t p the covid- pandemic is revealing the unacceptable health disparities across new york city and in this country. the mortality rates of vulnerable and minority populations alone suggest a need to re-evaluate clinical decision making protocols, especially given the recently passed emergency or disaster treatment protection act, which grants healthcare institutions full immunity from liability stemming from resource allocation/triage decisions. here we examine the disparity literature against resource allocation guidelines, contending that these guidelines may propagate allocation of resources along ableist, ageist and racial biases. finally, we make the claim that the state must successfully develop ones that ensure the just treatment of our most vulnerable. the coronavirus disease (covid- ) pandemic has disproportionately affected the most vulnerable populations in new york city and throughout the country. a total of % of those requiring hospitalization have underlying chronic health conditions [ ] . new yorkers over constitute % of covid- hospitalizations in the city, despite comprising only . % of the population [ , ] . the cdc has reported that nationwide, % of hospitalized patients have been african american, despite the fact that only comprising % of the general population; in new york state, african americans constitute % of deaths due to covid- , twice the number of their percentage of the population ( %) [ , ] . low-income communities also suffer disproportionately: new york city zip codes in the bottom % of average incomes constitute % of the city's cases, whereas zip codes in the top % constitute under % of cases [ ] . yet while much of the evidence and commentary around disparity outcomes of covid- addresses the differences in the underlying health status of those most severely affected, there is minimal discussion examining whether resource/triage allocation or liability policies may also be playing a role in exacerbating disparity outcomes [ ] [ ] [ ] [ ] [ ] [ ] . covid- has also shone a bright light on some gaping holes in emergency preparedness systems. particularly, it has brought to light difficulties with insufficient medical supplies and rationing of resources, precipitating the previously unthinkable: how to triage resources in the case of an absolute deficit. the triage policies proposed by states and hospitals around the country have been nonuniform at best [ ] . one common element among these heterogeneous policies is the tendency to further disadvantage the vulnerable populations already affected by covid- (see table for a list of state policies and their distinguishing features). the most widely-commented on form of discrimination has been that of policies that disadvantage the disabled community. a recent study conducted by the association of bioethics program directors (abpd) surveying the ventilator triage protocols of hospitals around the country found that . % of hospital protocols factor resource conservation into their protocol criteria, designating that individuals in need of increased clinical attention and resource-use are a lower priority [ ] . only . % of policies specified that allocation decisions should not be based on disability and some of these policies themselves included decision criteria that would disproportionately disqualify the disabled community [ ] . disability rights new york, an advocacy group for persons with disabilities in new york state, has previously filed a complaint against the new york department of health for its ventilator triage policy, which failed to specify that allocation decisions ought exclude disability. the complaint argues that without explicit instruction urging awareness against implicit bias, hospitals will disproportionately categorize disabled persons as having conditions that disqualify them from ventilator access, even when these conditions do not impact their short-term potential to survive [ ] . advocates have also argued that submitting chronically disabled persons to the same clinical litmus tests for ventilator allocation as healthy persons, such as difficulties at the time of extubation, denies equal access of healthcare facilities to the disabled community [ , ] . less attention has been paid to age-based discrimination. new york's guidelines acknowledge the inequity of factoring age into allocation decisions, but establish a 'tie-breaker' in which children under the age of will be given priority over adults in the case that both would benefit equally from ventilator use [ ] . a total of % of policies assessed in the abpd study utilized age in their criteria [ ] . discrimination against racial minorities may be a feature of any policies that include the presence of comorbidities in their decision criteria. african american patients are three-times more likely to have kidney failure than their white counterparts, nearly twice as likely to suffer congestive heart failure, % more likely to have high blood pressure and less likely to have that blood pressure under control, have higher reported rates of sepsis and are % more likely to have chronic liver disease [ ] [ ] [ ] [ ] [ ] [ ] [ ] . hispanic patients are . -times more likely to have kidney failure than their white counterparts, . -times more likely to suffer congestive heart failure, have higher reported rates of sepsis and are twice as likely to have chronic liver disease [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] . per the abpd study, % of ventilator triage policies utilize the sequential organ failure assessment scores to determine allocation of resources, where higher scores often tend to correlate with worse outcomes and increased baseline comorbidities [ , ] . in light of this, there has been public outcry by physicians that these policies inevitably bias resource allocation away from minority populations with higher likelihood of worse initial assessments that underscores these comorbidities [ ] . low-income populations, who also suffer a higher rate of comorbidities, may also be negatively impacted by these policies compared with their wealthier counterparts [ ] . substantive protocol aside, certain procedural features also need to be examined to ensure just treatment. only . % of hospitals require allocation decisions to be blinded [ ] . on the one hand, granting decision-makers knowledge of the patient's nonclinical characteristics may introduce the possibility of implicit bias playing a role in triage decisions, especially given that biases in medicine have been shown to be exacerbated in high-stress environments [ ] [ ] [ ] [ ] . alternatively, it may be that identity-blind triage criteria do more harm than good; by ignoring the reality that social determinants of health disproportionately disadvantage minority communities, triage criteria that seek to maximize lives saved without correcting for these disadvantages will further deprioritize the lives of the most at-risk groups [ ] . balancing consideration of comorbidities that matter to overall survival with a just and equitable allocation of resources continues to prove difficult for many institutions [ ] . further, the historic difficulty behind successfully incorporating factors such as race into healthcare policy to increase equitable outcomes highlights the acute need for meticulously thought-out policies, developed according to input from physicians and experts well versed in equity issues and from diverse backgrounds [ ] . the protocols mentioned above have been defended on the grounds of providing the greatest public benefit during the pandemic. the new york guidelines, specifically state the aim of these protocols are to "[encourage] allocation practices best suited to maximizing public health" [ ] . undoubtedly, preserving public health during a pandemic is crucial, but protocols that exacerbate disparities based on race, age or disability do not serve the public interest a priori. yet, the appeal to public benefit to justify unjust treatment of the marginalized is not a new concept. historically, charitable hospitals have tried to claim total immunity from civil or criminal liability stemming from malpractice suits by arguing that their charitable trusts were designed to be used to continue treating patients for free, rather than to compensate poor patients who had suffered from negligent treatment (silva v. providence hospital of oakland, england v. hospital of good samaritan, wilmington general hospital v. manlove) [ ] [ ] [ ] . in the landmark case tunkl v. regents of the university of california ( ), the court decided that ucla medical center could not force indigent patients to sign a contract releasing ucla from all malpractice liability in exchange for treatment, establishing that the most vulnerable in our population shall not have their rights denied [ , ] . the majority opinion explains that 'public interest' is not something that can be narrowly defined; in "the integrated. . . society of today, structured upon mutual dependency. . . .prearranged exculpation from [a hospital's] negligence. . . necessarily affects the public interest" [ ] . the same rings truer today than ever: in an interdependent society, prearranged exculpation from harms to our most vulnerable is itself a threat to the public interest. but nearly years after tunkl, similar ethical quandaries have been tied to the covid pandemic. on april , as a part of the - new york state budget, the 'emergency or disaster treatment protection act' (edtpa) was signed into law [ ] . the act grants healthcare workers, including physicians, administrators and hospital managers, immunity from criminal and civil liability for harms and damages resulting from the covid- crisis. immunity will not be granted for acts constituting willful or intentional criminal misconduct, gross negligence, reckless misconduct or intentional infliction of harm. however, edtpa states explicitly that acts, omissions and decisions resulting from resource or staffing shortages will not be considered to fall into any of those aforementioned categories ( § ) [ ] . in other words, the act constructs prearranged exculpation from a hospital's negligence. the immunity granted from the threat of a malpractice suit to healthcare workers and volunteers treating covid- patients with limited resources and at potential risk to their own safety is a widely praised development [ ] [ ] [ ] . however, the breadth of roles granted immunity and the wording of the act raises concerns about the fate of marginalized communities in the case of the covid- situation worsening. past literature that has called for physician immunity during public health emergencies for all but gross negligence and intentional misconduct, as the edtpa does, has still maintained that certain acts, such as extubation of one patient to benefit another, should not be entitled to immunity because they would fall under the gross negligence or the intentional misconduct umbrella [ ] . the edtpa's explicit protection of triage/resource allocation decisions, given the concerning ethical implications of the existing protocols, has major implications for preventing and holding institutions accountable for disparity outcomes. there is an explicit difference between tunkl and related cases and the covid pandemic and this difference is the key to this looming ethical problem: hospitals are not now seeking to disenfranchise their patients, but rather the opposite. during this crisis, healthcare and allied hospital essential workers have shown that they will risk their own lives to help their patients. many of the unorganized and discriminatory policies that hospital triage protocols around the country have exhibited may be a symptom of difficult decision making during an all-encompassing pandemic, not of malintent. according to the abpd study, % of hospitals nationwide have not had time to draft official policy at all; this percentage is likely much higher across all hospitals, since the abpd study only surveyed hospitals with bioethics programs, which may be more likely to have the appropriate infrastructure to create such policies in the first place [ ] . according to the new york guidelines, hospitals have "stressed that they are eager to follow state-level guidance" and have "expressed a preference for state guidance over drafting their own policies" [ ] . the solution, then, is clear: the state must come forward with a protocol that adequately secures the rights of the vulnerable and disseminate it to our hospitals. vulnerable populations deserve just treatment and our healthcare workers deserve the immunity that the edtpa grants them: these two just deserts are only in tension when our policies discriminate against the vulnerable and the state leaves them with no recourse to be compensated for the damages they suffer. unfortunately, the state has not done this. the new york protocols are plagued with issues; in addition to their discriminatory clauses, this protocol has not been updated to reflect decision-making more likely to occur with covid- , such as clinical judgement concerning likelihood of multiorgan failure or predicting length of mechanical ventilatory needs prior to intubation. however, even if this protocol were perfect, the greater issue is that it has been abandoned by state leadership. andrew cuomo declared 'there's no protocol' when asked about triage policy for resource management and a department of health spokesperson, directly contrary to the existence of the guidelines, stated explicitly 'we have no guidelines' when asked [ , ] . the importance of having a standardized framework for triage decisions is not merely a matter of ensuring that each document contains just policies. standardization is in itself a virtue during a crisis: the cdc states that, "making decisions about ventilator distribution and triage using a standard framework for incident management creates a clear hierarchy of accountability and responsibility, facilitates consistent communication and helps minimize differential treatment of patients" [ ] . across medicine the use of standardized protocols has been shown to decrease medical provider implicit bias and has been shown to decrease healthcare disparities [ , ] . crucially, a standardized document would also ensure that each hospital has a robust triage decisions appeals process in place, since the total immunity granted to healthcare workers and institutions by the edtpa renders legal avenues of appeal moot. according to the abpd study, less than % of hospitals have appeals processes in place and only . % specify methods for retrospectively reviewing their own decisions to ensure their policies are being implemented fairly [ ] . in tunkl v. regents of the university of california, the state came down on the side of the vulnerable against the interests of the hospital. thankfully, today there does not need to be any weighing of the rights of marginalized communities against the rights of healthcare workers during this crisis. today we see our healthcare workers risking their lives for their communities; the liability protection that the edtpa grants them is welcome and just. the state must now provide and actively promote a framework that ensures that our physicians can continue providing for every community, especially the marginalized. creating a truly just policy will likely entail working under multidisciplinary collaboration with healthcare workers, bioethicists and other healthcare professionals with the goal of protecting vulnerable and at risk populations. indeed, time is running out. financial & competing interests disclosure who's hit hardest by covid- ? why obesity, stress and race all matter but hospitalization rates for new york city's oldest coronavirus patients went up in the last week age and sex distribution -by county coronavirus is disproportionately killing the black community minorities hit harder by covid- , data shows these graphs show how covid- is ravaging new york city's low-income neighborhoods ventilator triage policies during the covid- pandemic at u.s. hospitals associated with members of the association of bioethics program directors ventilator rationioning -ocr complaint final.pdf the new york times. i will not apologize for my needs new york state department of health. ventilator allocation guidelines ( ). www.health.ny.gov/regulations/task f orce/reports publications/docs/ventilator guidelines.pdf . national kidney foundation. race, ethnicity & kidney disease differences in the incidence of congestive heart 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wisconsin hospital association. wisconsin adult ventilator guidelines the authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. this includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.no writing assistance was utilized in the production of this manuscript. key: cord- -u vme c authors: eussen, björn g.m.; schaveling, jaap; dragt, maria j.; blomme, robert jan title: stimulating collaboration between human and veterinary health care professionals date: - - journal: bmc vet res doi: . /s - - -x sha: doc_id: cord_uid: u vme c background: despite the need to control outbreaks of (emerging) zoonotic diseases and the need for added value in comparative/translational medicine, jointly addressed in the one health approach [one health initiative (n.d.a). about the one health initiative. http://www.onehealthinitiative.com/about.php. accessed september ], collaboration between human and veterinary health care professionals is limited. this study focuses on the social dilemma experienced by health care professionals and ways in which an interdisciplinary approach could be developed. results: based on gaertner and dovidio’s common ingroup identity model, a number of questionnaires were designed and tested; with progress, the relation between collaboration and common goal was assessed, mediated by decategorization, recategorization, mutual differentiation and knowledge sharing. this study confirms the common ingroup identity model stating that common goals stimulate collaboration. decategorization and mutual differentiation proved to be significant in this relationship; recategorization and knowledge sharing mediate this relation. conclusions: it can be concluded that the common ingroup identity model theory helps us to understand how health care professionals perceive the one health initiative and how they can intervene in this process. in the one health approach, professional associations could adopt a facilitating role. to control outbreaks of (emerging) diseases at an early stage, effective collaboration between human and veterinary healthcare professionals is essential [ ] . however, to date, collaboration has taken place only on a very limited scale [ ] [ ] [ ] [ ] [ ] [ ] . for this reason, one health, an interdisciplinary approach addressing the connections between health care for humans, animals and the environment and focused on the elements biomedical research, enhanced public health efficacy, an expanded scientific knowledge base and improved medical educational and clinical care in which human and veterinary healthcare and other stakeholders work together [ ] , is placed high on the agendas of organizations such as the who, the european commission's directorate-general for health and consumers, usa centers for disease control and prevention [cdcp] and worldbank [ , [ ] [ ] [ ] . because more than three-quarters of all the infections seen in humans originate in animals [ ] , there is great and widespread interest in the effective collaboration between human and veterinary healthcare professionals as a means to halt outbreaks of infections at an early stage. the outbreak of severe acute respiratory syndrome (sars), for instance, which was not even known to be an animal-transmitted infection when it first occurred, is estimated to have caused a loss of as much as us$ billion in terms of gross domestic product (gdp) worldwide [ ] . other examples include the recent outbreaks of avian influenza and q fever in the netherlands, which have shown that serious outbreaks can have major consequences for human and animal health [ ] . areas where close cooperation would be fruitful because they share the same goals include combatting and controlling zoonoses and emerging zoonoses; here, the interdependence of the two fields requires an integrated approach. in efforts to reach mutual goals, an interdisciplinary exchange of knowledge between the two professional groups can lead to a sharing of domainspecific expertise and experience, thus enabling experts to identify possible zoonotic infections and to fight them with the help of appropriate control measures at earlier stages [ ] . another advantage of collaboration between these two groups of healthcare professionals, besides the more adequate fight against infectious diseases, is the exchange of knowledge on the treatment of diseases [ ] leading to major healthcare cost savings [ , ] and to new scientific insights [ ] . in order to better understand the mental motivation of health care professionals with respect to the one health approach, this study used psychosocial concepts such as social dilemma, (group) identification and category thinking. collaboration can be defined as "any action which is intended to benefit others, regardless of whether the actor also benefits in the process" [ ] . however, collaboration can also fail to take place: in human and veterinary healthcare, cooperation between professionals can fail to materialize because there is a social dilemma, for instance. to illustrate, there are situations in which a noncooperative course of action is (at times) tempting for each individual in that it yields superior (often short-term) outcomes for the individual himself or herself [ ] . for example, it is commonly accepted that professionals have a constant and permanent responsibility for their patients, who expect care and action in the short term. a healthcare professional may therefore view collaboration, which may (at times) exceed or influence his own day-to-day operations, as not sufficiently important, at least for the short term. but if everyone pursues this non-cooperative course of action, then everyone will ultimately be worse off (often in the longer term) than would have been the case if everyone had collaborated. collaboration between human and veterinary healthcare professionals can be characterized as a social dilemma. it is often thought that a lack of time is the main reason why healthcare professionals feel they have so little psychological room for greater collaboration. fleuren, wieferink and paulussen [ ] , however, show that healthcare professionals actually have other reasons than time; what lies at the heart of their limited cooperation is a lack of clarity as to why collaboration should be organized in the first place. the individuals concerned do not always have a sufficiently well-defined idea of the benefits offered by increased contact and collaboration, even though collaboration is highly desirable both for the sector itself and for society as a whole [ ] . in this regard and in any event, the (long-term) awareness of sharing a common goal is of crucial importance. collaboration is stimulated if the (perceived) benefits outweigh the individual arguments or circumstances of the healthcare professionals concerned. this type of calculation, or dilemma, can lead to cooperation 'for the public good'. considering its objectives, one health can be seen as a public good dilemma, because "public good dilemmas require individuals to make an active contribution to establish or maintain a collective good, such as building a local bridge or joining a social movement" [ ] . however, in terms of making room for the bigger collective goal alongside their responsibilities related to the day-to-day care of their own patients, human and veterinary healthcare professionals often see insufficient added value [ ] , even though a greater awareness of the added value associated with collaboration would ultimately result in improved care [ , , ] . greater awareness of the added value brought about by collaboration on the part of healthcare professionals is consistent with the social desire for more intensive collaboration between human and veterinary healthcare [ , [ ] [ ] [ ] ] . these two groups of healthcare professionals speak the same 'language' and should therefore be able to understand each other well [ ] . despite the fact that, broadly speaking, both groups followed similar training programmes [ , ] and perform similar clinical procedures, there is hardly any exchange of knowledge and experience [ ] . in addition, a clear focus on common goals is lacking, and collaboration between human and veterinary healthcare professionals remains limited at present [ , , ] . so far, collaboration has only taken place in a limited number of research areas and only occasionally during outbreaks of emerging diseases [ , ] . closer examinations have revealed that the limited scale of collaboration is due, among other things, to mutual prejudices [ ] and psychological barriers between the parties concerned [ ] . such mutual judgements and prejudices may disrupt the development of collaboration, but research into these phenomena has so far remained very limited. the present study is aimed to help fill that gap. in order to gain a better understanding of what stimulates cooperation among healthcare professionals, we used the common ingroup identity model developed by gaertner and dovidio [ ] . this theory provides insight into the relationship between individual perceptions and behaviours towards groups and lists possible causes which may influence these. according to the common ingroup identity model, sharing a common goal affects the degree of collaboration, but this relationship is also influenced by the perception of this degree and the means of categorization [ , ] . the common ingroup identity model [ ] focuses on the individual's perception with regard to the group. in essence, the model states that members who see themselves as belonging to a larger, common whole consciously classify themselves within that larger whole, as a result of which prejudices between groups or communities decrease. according to gaertner and dovidio, collaboration is influenced by characteristics (in this study qualified as the common goal) which play a role in the individual perception of the situation: does the individual perceive the existence of a single overarching group, several groups or subgroups, or no group at all? if individuals feel that they belong to a group, in this case 'healthcare' , this will lead to more positive thoughts, feelings and behaviours among the individuals in the groups concerned [ ] . as explained above, when group members see themselves as part of a larger whole and when they classify themselves within this structure, prejudice between groups or communities is reduced. according to kramer and brewer [ ] , people within a group or an overarching whole are prepared to share communal resources and other supplies, but they will develop resistance if these have to be shared with others outside the group. still, a change occurs if these outsiders can be placed within a perceived larger whole. the realization that there is in fact a larger whole means that the positive thoughts, feelings and behaviours (such as the sharing of resources and information) which would normally be reserved for the individual's own familiar group are extended to members of other communities who also belong to the larger overarching whole. common endeavour and classifying thus go hand in hand, leading to feelings of 'us' rather than feelings of 'us versus them'. in other words, it depends on how an individual sees his group or subgroup within a larger whole [ ] . using the common ingroup identity model, we quantitatively assessed healthcare group interrelationships in order to gain insight into the contributions towards cooperation that can be made by means of a common goal for healthcare professionals formulated via their perception of group formation. in the past, the common ingroup identity model was researched primarily in experimental studies, with a main focus on perceived group formation [ ] . a limitation of the model is that the duration of the effect of an intervention is unclear, as is the reduction of bias [ ] . the current study will not only indicate whether the common ingroup identity model is useful for the respective groups of healthcare professionals, but it will also quantitatively assess the relationships between the common goal and collaboration in combination with associated mediating factors. in this way, the study will contribute to further theoretical development in terms of validation as well as to the quantitative usefulness of the common ingroup identity model. it will also examine whether the exchange of knowledge is an additional trigger for collaboration once healthcare professionals have become aware of the common goal. in the social dilemma referred to earlier, where there is insufficient awareness of the possible advantages of collaboration, and in this case human and veterinary collaboration, crucial factors include the reasons why healthcare professionals place themselves in a particular category and identify with their 'own' professional group [ , , ] . it is 'natural' for people to engage in social categorization: the brain is hard-wired to think in terms of categories, and categories form the basis for standard judgements and prejudices [ ] . the advantages of social categorization are that individuals know where they stand and what is expected of them, and that a group or community contributes to a feeling of (social) well-being [ ] . the same is true of human and veterinary healthcare professionals, although a certain distance is maintained between them [ , ] . after all, what is qualified by the terms 'human' and 'animal' is placed in different categories. this is illustrated by the dichotomy between the two professional groups, established on the basis of typical activities, with 'human patient' being contrasted with 'animal patient' , and hence on the basis of categorybased thinking [ ] . still, mutual contact alone does not lead to productivity or better joint results; for good results, interdependence is necessary [ , ] . if individuals perceive a common goal, in this case 'improving care through one health' , then according to the common ingroup identity theory this can be expected to lead to more positive thoughts, feelings and behaviours between individuals in the groups concerned [ ] , because there will then be more perceived interdependence between the two groups. according to the common ingroup identity theory, the awareness of a larger whole or a common ingroup, in this case a joint responsibility for improving care, will lead to the extension of positive thoughts, feelings and behaviours (such as the sharing of resources and information) that were traditionally reserved for the individual's own familiar group to members of other communities who also belong to the larger overarching whole. in the case of common goals and interests, a clear interdependence can be seen: after all, the aim is to achieve a result which requires contributions from both groups. in their model, gaertner and dovidio [ ] describe a common goal in terms of 'interdependence'. in this respect, collaboration between human and veterinary healthcare professionals is the result of addressing common goals and interests [ , , , , ] . this is in line with the social interdependence theory which argues that interdependence results from a common goal [ ] [ ] [ ] [ ] [ ] . mutatis mutandis, this altruistic goal was recently incorporated in the one health initiative ( ) . this means that one health, as a common goal, can be expected to lead to greater collaboration. this brings us to our first hypothesis: one health as a common goal has a positive effect on collaboration between human and veterinary healthcare professionals. the process of classifying concerns the individual's perception of the connection betweenin this casetwo groups of healthcare professionals: how an individual sees his group or subgroup within a larger whole and whether the individual perceives the existence of a single overarching group, multiple groups or subgroups, or no group at all [ ] . as described earlier, one health can affect how people see themselves as part of a larger, common whole and how they classify themselves within that larger whole. the common ingroup identity theory distinguishes the following types of perception and reclassification: recategorization, decategorization and mutual differentiation [ ] . these types are elaborated below. perceived commonality and perceived common goals (overlap between groups and a stronger feeling of 'us' rather than 'us and them' , recategorization) result in greater collaboration [ , ] . that being said, the feeling of 'us' is not by definition limited to a single group: a person can possess multiple identities because he or she can be a member of multiple groups [ ] . this means that in addition to classifying themselves in the veterinarians' group, veterinarians could also classify themselves in the (overarching) group of healthcare providers [ ] . we speak of recategorization when an overarching identity is perceived in which old groups are represented as a whole or in a new form, for example as a subgroup. via the formation of a subgroup, collaboration between the two groups of healthcare professionals is further enhanced, for instance through awareness of a common goal. this brings us to our second hypothesis: the positive relation between common goal and collaboration is mediated by the partial effect of recategorization. according to gaertner and dovidio [ ] , a common goal causes perceptions to be reclassified into changed perceptions, thus leading to greater collaboration. it may be expected that if healthcare professionals become aware of a common goal, there will be room to recognize the overlap with the other group of healthcare professionals. this type of development is also known as decategorization. if a certain situation is perceived as a form of decategorization, the emotional group connections become less important, so that there will be room for individuals to recognize shared identities. in turn, this will lead individuals to have more extensive contacts with other individuals, as a result of which prejudices will decrease and positive attitudes towards people in a different group can be developed [ ] . this brings us to our third hypothesis: the positive relation between common goal and collaboration is mediated by the partial effect of decategorization. brown and wade [ ] and molleman, broekhuis, stoffels and jaspers [ ] conclude that if one wishes to stimulate collaboration, both groups must be able to retain their old identity. it is possible for the two groups to collaborate, but the researchers believe it is important that both groups continue to operate separately and that both fulfil a complementary role within the framework of their common goal. such a structure, with interdependence and individual space for each group, will ultimately reduce prejudice and tension on either side [ , , ] . this perceived commonality can then lead to greater collaboration [ , , ] . a thorough understanding of interdependence and common endeavour has a psychological effect on interaction, interrelationships and collaboration: it leads to recognition, stimulation and interaction [ ] . in the case of mutual differentiation as a social categorization perception, there is appreciation of the knowledge and expertise on the part of the other professional group. according to gaertner and dovidio [ ] , 'there is a winwin situation which produces positive feelings and stereotyping towards the other group, while the individual's own group can define its own profile'. in the case of recategorization and mutual differentiation, it is important in both cases that the original identity is not abandoned when collaboration takes place. both groups will then be able to retain some autonomy within a common whole and they will not stray too far into each other's territory [ ] . where the common goal (in casu one health) is perceived as collaboration by mutual differentiation, a special focus lies on the importance of each of the groups with respect to their different qualities and expertise. hewstone and brown [ ] state that collaboration should be focused on complementary knowledge and expertise. collaboration will be triggered by paying attention to each other's knowledge and expertise, as a function of the clarity of a common goal. this brings us to our fourth hypothesis: the positive relation between common goal and collaboration is mediated by the partial effect of mutual differentiation. ives, torrey and gordon [ ] argue that having a clear common interest leads to situations in which an exchange of knowledge can take place. in addition to what follows from the common ingroup identity model, it can be assumed that knowledge sharing leads to collaboration because individuals can use each other's expertise [ ] [ ] [ ] . knowledge sharing between teams and groups improves performance and effectiveness [ ] [ ] [ ] . added value can be achieved by having professionals from different backgrounds learning and working together, thanks to the possibilities offered in terms of exchanges, the integration of knowledge and innovation. advantages are particularly associated with the sharing of implicit knowledge and new insights [ ] . collaboration is promoted by knowledge transfer through informal or small-scale processes and lateral, social contacts [ , ] . kramer and brewer [ ] showed that individuals were particularly inclined to share knowledge with others within their own group, but also that they can be more reticent with more distant contacts. in that case, and especially in the case of one health, it is important to address perceived distance; when others are perceived as less distant, they will have fewer reservations to collaborate within the framework of one health. finally, holmes [ ] demonstrates a positive connection between (continuing) knowledge sharing and mutual ties, trust within a group and collaboration [ , , ] . this brings us to our fifth hypothesis: the positive relation between common goal and collaboration is mediated by the partial effect of knowledge sharing. our study sample consisted of respondents. by means of a digital newsletter from the professional organizationsthe royal dutch veterinary association (knmvd) and the royal dutch medical association (knmg)human and veterinary healthcare professionals were invited on a one-off basis to complete the questionnaire. the questionnaire was sent to , human and veterinary healthcare professionals. in addition to these professional associations, human and veterinary healthcare professionals were contacted via social media such as linkedin and twitter. a total of healthcare professionals responded, of whom completed the survey in full. of the respondents, ( %) were human healthcare professionals; ( %) were veterinary healthcare professionals. the low response rate demonstrated by the group of human healthcare professionals could be explained by their limited interest in the one health topic [ ] . an illustration of this can be found in the difference in attention paid to the topic in the professional body's journals. during the last five years, one health was mentioned only nine times in the weekly dutch journal of human healthcare professionals; in contrast, every monthly issue of the veterinary journal elaborated on the topic. of all our respondents, % were female. the average age of the respondents was , and respondents had been working in the profession for an average of approximately years. % of respondents were still active in clinical practice and % were working outside clinical practice. of the healthcare professionals, respondents ( %) had completed their studies in utrecht. % of respondents had studied abroad, and of these more than % had studied in belgium. of the respondents, ( %) were members of the professional association, over % regularly read a professional journal in their own field, and fewer than % regularly read a professional journal in another field. of the human healthcare professionals, % had a specialization listed in the dutch healthcare professions register (big). in the veterinary sector, the respondents included domestic animal veterinarians, equine veterinarians, farm veterinarians and special animal veterinarians. these general figures tally with the figures obtained from the professional associations; there are no indications of bias. the variables were measured with a series of questions that had been compiled from various existing validated questionnaires. many original items were adapted to the specific situation of human and veterinary healthcare professionals in order to ensure that the items were meaningful to them. the questionnaire took approximately min to complete. apart from a number of open questions (related to age or the number of working years), all items were based on a likert scale ( - ) and can be interpreted as continuous variables, thus following the fundamental ordinary least square (ols) principles. the sevenpoint scale was used to obtain greater dispersion and hence more nuance in the data [ ] . table reports the general descriptives of the variables (mean, sd, alpha and correlations). the dependent variable, collaboration, was based on bock, zmud, kim and lee [ ] with a construct reliability score of . , to which the one-item question on the perceived degree of overlap formulated by schubert and otten [ ] was added (the osio -overlap of self ingroup and outgroup). an example of an item is 'i collaborate when the opportunity arises'. common goal was based on fisman and laupland [ ] and kahn [ ] and has a construct reliability score of . . participants were asked the following: "thinking of possible collaboration between physicians and veterinarians, to what extent do you agree with the following statements?". an example of an item is 'i think more could be done to stimulate innovation in healthcare'. recategorization was measured with questions based on edmondson [ ] with a construct reliability of . . an example of an item is 'in the collaboration between physicians and veterinarians in general, it is possible to raise problems and difficult subjects in the collaboration'. decategorization was measured with a combination of items based on the instruments developed by doosje, ellemers and spears [ ] and shamir, zakay, breinin and popper [ ] . an example of an item is 'in the collaboration between physicians and veterinarians in general, it is considered important to make a lasting contribution to the collaboration'. mutual differentiation was measured with questions based on berendsen, benneker, groenier, schuling, grol and meyboom-de jong [ ] with a construct reliability of . . an example of an item is 'in the collaboration between physicians and veterinarians in general, there is appreciation of the expertise of the other professional group and a readiness to pursue contact on it'. knowledge sharing was based on connolly and kellaway's study [ ] with a construct reliability of . . an example of an item is 'in the collaboration between physicians and veterinarians in general, i am prepared to share specific professional knowledge (expertise) with the other professional group'. the study sample consisted of respondents. this size is acceptable in view of the rule of thumb provided by barclay, higgins and thompson [ ] , which suggests using ten times the maximum number of paths aiming at any construct in the outer model (this is not applicable as no formative constructs were used) and the inner model. all construct variables (collaboration, common goal, recategorization, decategorization, mutual differentiation, and knowledge sharing) are reflective constructs. for the outer model evaluation, internal consistency reliability and convergent validity were examined. the construct reliability scores ranged between . and . , which was acceptable [ ] , and for the convergent validity the average variance extracted (aves) of the constructs was also good [ ] ; this is included in table . secondly, indicator reliability was examined and all factor loadings were found to be higher than . and as such acceptable [ ] . the construct and the factor loadings proved to be satisfactory for use in the analysis, although it can be said that the coefficients of the determinants are lowand that they are negligible in the case of mutual differentiation and decategorization for collaboration. finally, discriminant validity was checked, comparing the aves of the constructs with the inter-construct correlations [ ] . additionally, cross-loadings were checked. evidence was found to exclude three items from mutual differentiation due to cross-factor loadings. partial least squares path modelling (pls-sem) was conducted with smartpls version . [ ] . for the partial least square algorithm, the path weighting scheme was used, and the maximum number of iterations was set to . as stop criterion, ^- was used. a uniform value of was used as an initial value for each of the outer weights [ ] . table shows the correlations between de different variables. reliability and convergent validity of the measurement model was also confirmed by computing standardized loadings for indicators ( table ) and bootstrap t-statistics for their significance [ ] , see table . for this bootstrapping, subsamples were used with a bias-corrected bootstrap testing for a two-tailed significance of %. the coefficient of determination was found to be moderate for collaboration (r = . ). the effect size of common goal on collaboration (f = . ), recategorization on collaboration (f = . ) and knowledge sharing on collaboration (f = . ) can be considered small [ ] . the effect sizes of decategorization on collaboration (f = . ) and mutual differentiation on collaboration (f = . ) were negligible. to obtain the q values as an indicator of the model's predictive relevance, the blindfolding procedure was used, resulting in small predictive relevance for collaboration (q = . ), knowledge sharing (q = . ), and mutual differentiation (q = . ). the effect size for the predictive relevance of common goal on collaboration was very small (q = . ), as was knowledge sharing on collaboration (q = . ). finally, the procedures outlined by preacher and hayes [ ] were followed to examine multiple mediation effects. with the help of multiple mediation models, it is possible to observe not only the direct effect of common goal on collaboration, but also the mediation effects. the mediation effects are a b = . (through recategorization), a b = . (through decategorization), a b = . (through mutual differentiation), and a b = . (through knowledge sharing). figure was designed based on the calculated mediation effects. all paths show a significant relation. this makes the common ingroup identity model an effective model to provide a plausible explanation why human and veterinary healthcare professionals do or do not collaborate. having a common goal, like one health, leads to collaboration via recategorization. this mediating relation is also present for knowledge sharing. however, for decategorization and mutual differentiation, there is a significant relation with common goal and with collaboration; decategorization and mutual differentiation have a direct relation with collaboration that is not a mediating relation. the pls analysis confirms that a common goal promotes collaboration. hypothesis is therefore accepted. bootstrapping the indirect effects of common goal on collaboration, we found that recategorization ( , ) and knowledge sharing ( , ) are significant mediators, thus supporting hypotheses and . the specific indirect effect through knowledge sharing is larger than through recategorization (effect recategorization is significantly smaller; see contrasts) [ ] . significant relations were found between common goal via decategorization with collaboration and for mutual differentiation with collaboration. no evidence was found to support hypotheses (mediating effect of decategorization) and (mediating effect of mutual differentiation). nevertheless, the results indicate an intervening effect for decategorization and mutual differentiation, resulting in a satisfactory explanation why human and veterinary healthcare professionals do or do not collaborate. all four elements (recategorization, decategorization, mutual differentiation and knowledge sharing) are relevant; recategorization and knowledge sharing are mediating variables. common goal proved to be an important factor for promoting collaboration between human and veterinary healthcare professionals. this relationship is partly explained by the mediating role of recategorizing and knowledge sharing, but also partly by the intervening having a common goal (in casu one health) produces altered perceptions in the form of an overarching identity. upon recognizing their interdependence, human and veterinary healthcare professionals will initiate collaboration [ ] . collaboration, if there is a common goal, must therefore be seen to a greater extent as interdependence, as described earlier by mohr and spekman [ ] , in which there is still scope to retain individual identity, as argued by brown and wade [ ] and molleman et al. [ ] . in the case of recategorization, there is scope to retain individual identity since an overarching identity is created. gaertner and dovidio [ ] showed that a common goal leads to a reduction of prejudice and resistance between groups (thus influencing the perception of the situation), which in turn has an influence on collaboration. the current findings point in the same direction. this study shows that in addition to recategorization, knowledge sharing also has a mediating role with respect to the influence of a common goal (one health) on cooperation. findings indicate that one health stimulates knowledge sharing and in this way enhances collaboration between human and veterinary healthcare professionals. it may therefore be concluded that knowledge sharing is a promoting factor for human and veterinary healthcare professionals to use each other's expertise [ ] [ ] [ ] . the healthcare professionals have different backgrounds, but they improve their performance and make it more effective by learning from each other and by collaborating [ ] [ ] [ ] . one health is an important initiative to generate and promote knowledge sharing. this study has shown that knowledge sharing is in fact stimulated if the common goal of one health is perceived as an invitation to work together on the basis of mutual interdependence. seen in this way, continuous knowledge sharing will ultimately improve the ties and the forms of collaboration between the two groups of healthcare professionals [ ] . this study has also shown that decategorization has a significant effect in the relation between common goal and collaboration, although this is not a mediating but an intervening effect. our analyses show that this path, which has also been described by gaertner and dovidio [ ] , also applies to the human and veterinary healthcare professionals. many healthcare professionals will be of the opinion that decategorization is not sufficiently concrete; they will therefore give it little importance, which might explain why we did not find a mediating effect. this study has also revealed that mutual differentiation expresses a significant relation between common goal and collaboration. however, as with decategorization, there is no mediating effect between collaboration and common goal for mutual differentiation. it may therefore be concluded that mutual differentiation helps to explain the collaboration between human and veterinary healthcare professionals. a possible explanation for the fact that no mediating effect was found for mutual differentiation may be limited insight in each other's sectors and expertise, and any untapped added value still to be discovered [ ] . the current study's findings indicate that in order to achieve greater collaboration between human and veterinary healthcare professionals, it is first and foremost necessary to define a common goal. that being said, the concept of one health is not yet sufficiently 'alive' in the heads of healthcare professionals. most of these professionals will probably not have a clear idea of how to interpret it, particularly in their own practice. having a clear common goal will likely help them overcome the social dilemma that healthcare professionals face. after all, these professionals will only be triggered to work together once the common goal is shaped and starts to come alive, as is also argued by ives, torrey and gordon [ ] . these researchers state that having a clear idea of the goal stimulates knowledge sharing. the social dilemma among healthcare professionals referred to earlier [ ] is thus overcome, and the added value of interaction becomes clear to them. a common goal (as investigated in this study) only comes into existence as a result of this concreteness, and this will trigger the mechanisms required to create an overarching identity [ ] . furthermore, it is of importance for both groups of healthcare professionals to know each other and to realize that they have a shared responsibility, not only in terms of combatting infectious diseases, but also in terms of providing optimum care for patients. this insight is expected to facilitate cooperation between the groups of healthcare professionals [ ] . the notion that there are differences between the two groups does not necessarily imply that there is no, or could not be any, collaboration between them [ ] . on the other hand, a word of caution is needed here: we have to be careful not to facilitate or create too much interference concerning the other professionals' fields, because this could result in resistance [ ] . professional associations can play a facilitating role in creating a common goal, promoting recognition and fostering awareness with respect to common responsibilities. knowledge sharing could be shaped, for example, by including articles from the other field in the professional journals of both professional groups. as respondents in the current study reported, fewer than % read a professional journal related to the other sector. the mutual inclusion of each other's articles could be a first step in creating a relatively simple form of knowledge transfer. in addition to the publication of articles in each other's professional journals, professional associations could offer joint interdisciplinary training programmes and refresher courses. it has become increasingly clear that greater awareness of the added value of the common goal results in more extensive cooperation [ , , ] . this awareness reveals not only what both groups of healthcare professionals have in common, but also that human and veterinary healthcare professionals have more in common than they themselves realize. this insight will lower the current psychological barriers between the two groups of healthcare professionals, resulting in more extensive collaboration between them [ ] . this awareness among both groups of healthcare professionals could be further improved via the communications issued by their professional groups. as the current study was a cross-sectional study, it has certain limitations concerning long-term effects or relations. in order to gain a deeper insight into possible causes and consequences, longitudinal research is needed. one health is an interdisciplinary approach and less concrete for healthcare professionals. to stimulate collaboration on the basis of the arguments presented in the current study's introduction, additional and more detailed research is necessary: although one health has been studied as an overarching concept, individual elements have been somewhat neglected. beyond that, we recommend more qualitative research on this subject. this is needed to obtain greater insight not only into 'physicians' and veterinarians' thoughts and feelings, but also into the overlaps between the two groups. in addition, an international study is needed to compare the different worlds. for instance, to the best of our knowledge, in the western world veterinarians generally are greater all-rounders than physicians, but in the developing countries we see that physicians are also allrounders; one would expect that the psychological barrier will be lower between these health care professionals. we expect this to have an influence on their cooperation. to the best of our knowledge, this study is the first research project in which the common ingroup identity model is quantitatively researched with the help of questionnaires. it is recommended that further research be conducted into this model with a view to using it in more quantitative analyses. collaboration between healthcare professionals -the one health approach -can be further investigated by focusing on other characteristics that influence the collaboration between the two groups. possible options are stereotyping and social value orientation. the healthcare sector, and specifically the interaction between the human and veterinary fields, offers untapped potential, such as the 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partnerschip attributes, communication behaviour, and conflict resolution techniques we would like to thank the following people: prof. dr. l.j. hellebrekers, for his support during the collection of data from veterinary healthcare professionals; prof. emer. dr. l. wigersma, for his support during the collection of data from human healthcare professionals; m.m. van houten msc ma, for revising the manuscript critically in terms of (intellectual) content and for textual corrections; l. kuipers ma, for editing the english text. not applicable. the dataset of the current study is available from the corresponding author upon reasonable request. avas: average variance extracted; big: dutch healthcare professions register; cdcp: usa centres for disease control and prevention; gdp: gross domestic product; knmg: royal dutch medical association; knmvd: royal dutch veterinary association; ols: ordinary least square; osio: overlap of self ingroup and outgroup; pls-sem: partial least squares path modelling; sars: severe acute respiratory syndrome; who: world health organization authors' contributions be is the study's initiator who carried out the data acquisition and drafted the article. be and js contributed to the conception and design of the study, provided input on the interpretation of the data and revised the article critically for important intellectual content. md performed the statistical analyses. rb contributed to the interpretation of data. all authors approved the final article. the authors declare that they have no competing interests. not applicable. no patients were involved in this study as all respondents were healthcare professionals (not being a patient). this means that written informed consent could not and did not need to be obtained from patients for the publication of this study. this study does not fall within the agreements of the helsinki declaration. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. submit your next manuscript to biomed central and we will help you at every step: key: cord- -iygxrlxg authors: maher, paul j.; maccarron, pádraig; quayle, michael title: mapping public health responses with attitude networks: the emergence of opinion‐based groups in the uk’s early covid‐ response phase date: - - journal: br j soc psychol doi: . /bjso. sha: doc_id: cord_uid: iygxrlxg partisan patterns of compliance with public health measures are a feature of early covid‐ responses. in many cases, these differences in behaviour relate to pre‐existing group identities. however, in times of rapid societal change, novel opinion‐based groups can emerge and provide a new basis for partisan identification and divergent collective behaviour. here, we use network methods to map the emergence of opposing opinion‐based groups and assess their implications for public health behaviour. in a longitudinal study, we tracked public health attitudes and self‐reported behaviour in a sample of uk participants over four time points. network visualisation reveal a rift in attitudinal alignment over time and the genesis of two distinct groups characterised by trust, or distrust, in science (study a; n = ). these groups also diverge in public health behaviour. in a brief follow‐up study (n = ), we find that this opinion polarization partially reflects underlying societal divides. we discuss implications for opinion‐based group research and public health campaigns. partisan patterns of compliance with public health measures are a feature of early covid- responses. in many cases, these differences in behaviour relate to pre-existing group identities. however, in times of rapid societal change, novel opinion-based groups can emerge and provide a new basis for partisan identification and divergent collective behaviour. here, we use network methods to map the emergence of opposing opinionbased groups and assess their implications for public health behaviour. in a longitudinal study, we tracked public health attitudes and self-reported behaviour in a sample of uk participants over four time points. network visualisation reveal a rift in attitudinal alignment over time and the genesis of two distinct groups characterised by trust, or distrust, in science (study a; n = ). these groups also diverge in public health behaviour. in a brief follow-up study (n = ), we find that this opinion polarization partially reflects underlying societal divides. we discuss implications for opinion-based group research and public health campaigns. effective societal responses to severe acute respiratory syndrome coronavirus (sars-cov- ) and the associated infectious disease (covid- ) pandemic require long-term and large-scale trust among disparate groups in society (vaughan & tinker, ) . worryingly, there is reason to believe that partisan compliance is a feature of covid- public health responses (e.g., allcott et al., ; van bavel et al., ) . even as restrictions ease, there is a danger of subsequent waves of infections if public health messaging cannot engender solidarity (haslam et al., ) . tracking the emergence of partisan rifts in public health attitudes allows social psychologists to map identity-based factions in public health behaviour. social influence is an important moderator of public health messaging. for example, communications implicitly convey group norms (nightingale, quayle & muldoon, ) and this can lead to misperceived health risks (berkowitz, ) and divergent health behaviour (jetten et al., ) . in the united states, attitudes and behavioural responses towards covid- rapidly diverged on political party lines (wise et al., ) , with democrats more likely than republicans to report vigilant handwashing and the avoidance of large crowds (yougov, ) . indeed, there is evidence suggest a partisan rifts in health behavior, even after controlling for alternative explanations (allcott et al, ; gollwitzer et al. ) partisan divisions in health attitudes and behaviours are detectable in the united states as they fall relatively cleanly along political divides. however, as previously seen during the brexit debate in the united kingdom, new 'opinion-based groups' (mcgarty, bliuc, thomas, & bongiorno, ) can emerge from social processes without clear relations to prior groups or socio-political structures. even in the us, the presence of ideological structure among public attitudes is often overemphasised (converse, ) . therefore, it is important to be able to track the dynamic emergence of any partisan rifts in public health attitudes without using preconceived categories or retrospective inference. for clarity, we describe these emergent opinion-based structures as factional to emphasize that they offer a new basis for identity alignment, as opposed to partisan structures that align with pre-existing socio-political identities. in this paper, we track public health attitudes in a sample of uk participants during the early stages of the covid- pandemic. using a novel network-based method, we explore whether opposing attitude-based clusters emerge over time and investigate whether factional attitude alignment becomes a basis for divergence in public health behaviour. attitudinal overlap can be the basis for perceived similarity and social group formation (macy, deri, ruch, & tong, ) , as observed in opinion-based groups (bliuc et al., ) . opinion-based groups are groups formed around shared opinions. importantly, these groups can form rapidly through online interaction (garcia, galaz, & daume, ) and foster forms of identification that transgress more categorical group boundaries. here, a single topic can become a nexus for social identification (bliuc et al., ) and intergroup conflict (bliuc et al, ) . for example, climate change 'sceptics' and 'believers' have distinct social identities based around global warming attitudes (bliuc et al., ) . a further defining feature of groups formed around shared attitudes is the ease with which they facilitate the coordination of behaviour. shared attitudes are a basis for collective identity and agency (mcgarty, et al., ) , since once you know what you stand for it is easy to agree on how to act. consensus on health-related attitudes can influence health behaviour (montoya-williams & fuentes-afflick, ) and facilitate coordinated online activity (garcia et al., ) . for example, garcia et al. ( ) tracked the rapid formation of an online community of twitter users connected through their disapproval of non-meat diets. in anticipation of an upcoming lancet report highlighting the science behind healthy and sustainable eating, the community coordinated the proliferation of #yes meat as a means to effectively dominate coverage of the launch on twitter. indeed, many forms of health communication are susceptible to misinformation and partisan persuasion (broniatowski et al., ) . we already see motivated partisan persuasion by disparate groups in the covid- pandemic (e.g., protests against lockdown), and this can undermine the solidarity required for public health compliance. in times of social crises, attitudes rapidly coordinate and polarize (smith et al., ) as people seek clarity from leaders and similar others (kruglanski et al., ; mueller, ) . thus, during the brexit process, previously innocuous opinions like one's view of the eu became a catalyst for long-term realignments in british politics (hobolt, leeper, & tilley, ) . similarly, economic and political attitudes polarized in the wake of the great recession (mccarty, poole, & rosenthal, ) and the election of donald trump (maher, igou, & van tilburg, ) . this attitude polarization may build upon pre-existing rifts (e.g., political divides) but it is often not reducible to political or demographic categorizations (mcgarty, et al., ) . covid- has spurred societal change at an alarming rate, and this too will shift the structure of attitudes in society. network methods reveal how even small changes can lead to rapid shifts in otherwise stable attitudinal relationships (dalege et al., ) . assessing the connection between attitudes in a network helps explain the central role of identity in coordinating beliefs and behaviour (brandt, sibley, & osborne, ) . importantly, attitudes propagate through group structures (jost, ledgerwood, & hardin, ) and can quickly coordinate into factional alignment. we propose that networks of attitude agreement simultaneously produce symbolic structures and group structures that bind people together (maccarron et al., ; quayle, ) and that social crises (e.g., pandemics) accelerate this process. in two complimentary studies, we investigate (i) the emergence of factional alignment in health attitudes during the early phase of the covid- pandemic, (ii) consequences for maintaining public health behaviour, and (iii) the contribution of pre-existing social categories. in the united kingdom, public trust in health officials is high and typically not a partisan issue (wellcome global monitor, ). however, in times of crisis, novel attitude coordination can occur as people seek clarity and certainty (e.g., mueller, ) . this study aims to (i) investigate whether emerging factions can be detected in public health attitude coordination and (ii) assess how this corresponds to public health behaviour. based on a preliminary network analysis of representative uk data with the same items (wellcome global monitor, ), we estimated that at least participants would be required to visualize opinion-based groups. to accommodate longitudinal attrition, we aimed for participants at time (t ). participation was restricted to uk residents recruited online through prolific academic (prolific.ac) and paid £ . per time point. we planned three waves of data collection to coincide with significant events in the uk government response to covid- . we collected t data on march, three days after the first reported fatality in the united kingdom. we excluded three participants for failing an attention check, leaving ( women; m age = . , sd = . ). we collected time (t ) data from the same participants a week later ( march; n = participants), three days after uk risk level was raised to high. we removed five for failing an attention check and nine others could not be matched to t . this left ( women; m age = . , sd = . ). time (t ) data were collected a week later ( march), three days after the closure of non-essential business and the ban on 'non-essential' travel in the united kingdom (n = ). two participants were removed for failing attention checks and a further could not be matched to both t and t . this left a final sample of ( women; m age = . , sd = . ) participants for analysis across all three time points. online supplementary materials contain all items answered by participants (https://osf. io/a hdn/?view_only=ee ced b ed ca f f b b ). we measured public health attitudes with items from the wellcome trust health survey (wellcome trust global monitor, ). these assessed participants' trust in: science, scientists, the government, doctors, journalists, charity workers, traditional healers, community, and vaccines. we measured compliance with public health advice with three items relating to physical distancing and handwashing which formed one compliance scale (t a = . ; t a = . ; t a = . ) . finally, three items assessed epistemic clarity. we asked participants how well they understood covid- precautions, how much they made sense and how meaningful they were (t a = . ; t a = . ; t a = . ). participants responded using -point scales ( = not at all; = a great deal). first, a bipartite graph (i.e., network) of public health attitudes was constructed for each survey time point. this is a graph with two types of nodes, where edges can only connect nodes of different types. the bipartite graph can be projected either to show how people are linked by shared attitudes or attitudes are linked by the people who share them. in figure , we show the participant projection at the three different time points. here, a link represents the proportion of attitudes shared by two participants. in time , we observe two clusters that are linked by a total of four edges (see supplementary materials for further details). a similar method is used for the attitude projection in figure . here, the edges represent the number of people sharing these attitudes. if the edge is blue, most participants align on these attitudes, if red there is mostly disagreement. for example, many participants who trust doctors distrust government and vice versa. please see online supplementary materials for more details. figures and reflect a specific form of consensus-based polarization, not evident in conventional mean-based comparisons. k-means clustering confirms the two distinct groups evident in attitude networks at t , and a chi-square independence test confirmed the correspondence of these groupings with those identifiable in the figures above, x ( ) = . , p < . . there is a larger cluster of white nodes (the science-trusting cluster; n = ) and a smaller cluster of yellow nodes (the science-sceptic cluster; n = ) at t . these emerged as consensus built within distinct groupings and differences built between them. over time, the number of people combining positive attitudes towards science with positive attitudes towards government and charity becomes smaller (evidenced by the reduction in edges across these components). we verified the clustering evident above by assessing individual-level attitude change between participants in each cluster in a repeated measures manova with time varying within-subjects, clusters between-subjects, and attitudes towards doctors, science, scientists, and vaccines as multiple dvs. we found a significant multivariate effect of time (f[ , ] however, these averages mask the time x cluster interaction, and univariate analysis reveals this is predominantly driven by a divergence in attitudes towards science, f( , ) = . , p < . , g = . and scientists, f( , ) = . , p < . , g = . . trust in science progressively decreased among those in the smaller cluster and increased among those in the larger cluster (see figure ) . hence, we refer to these clusters as science-trusters and science-sceptics, although we note that the network approach reveals attitudinal combinations not evident from analysing these variables independently. importantly, this system-level polarization would not have been evident without the network visualisation. we investigated whether these t clusters reflect opinion-based groups by assessing differences in behaviour compliance and epistemic clarity at t . participants in the science-sceptic cluster reported significantly lower behavioural compliance at t (m = . , sd = . ) compared to those in the science-truster cluster (m = . , sd = . ), f( , ) = . , p = . , g = . , % ci [ . , . ] and significantly lower epistemic clarity (m = . , sd = . ) than the more trusting group (m = . , sd = . ), f( , ) = . , p = . , g = . , % ci [ . , . ]. overall, attitude-network analysis has enabled us to identify novel groups, for which public health messaging appears to have divergent effects. study b explores whether the factional attitude alignment in study a builds upon existing social divides and whether the attitudinal clusters we identify reveal something that was less evident from other means of categorisation. we followed up study a participants at a th time point (t ) on april th , two weeks after t participation. altogether, participants took part, three failed attention checks and a further could not be matched to participants who took part in all three previous time points. this left us with a total sample of ( women; m age = . , sd = . ). we assessed a range of political and socio-economic demographic variables. political measures. we measured how people voted in the brexit referendum, as well as their views on brexit on a - scale ( = strong remain; = strong leave). we also assessed political orientation ( = left wing; = right wing) and general election vote. socio-economic measures. we measured annual income level ( = less than £ , ; = more than £ , ), educational level ( = primary education; = doctoral degree), area of residence (urban v rural v suburban), and perceived social status (adler et al., ) . we assessed how people in attitude-based clusters established at study a differed in brexit views, income, education, political orientation, and perceived social status. clusters differed significantly in these five measures (see table ). participants in the science-sceptic cluster favoured leave over remain, reported a lower average income, lower average levels of education, and lower perceived social status. chi-square independence analyses tested associations between cluster and brexit, general election vote, or residential area. only brexit vote was significantly related, x ( ) = . , p = . . although there was a higher than expected portion of leave voters in the sceptics cluster (n = ; from ), there was also a substantial number in the sciencetruster cluster (n = ; from ). furthermore, there were a number of non-voters in the sample (n = ). neither general election vote (p = . ) nor residential area (p = . ) was significantly related to attitude clusters. we assessed the contribution of each of these demographic factors in a multiple binary logistic regression. specifically, we examined whether the probability of a participant belonging to either attitude-based cluster was related to income, brexit view, education, political orientation, or perceived ses. the model significantly predicted group assignment, x ( ) = . , p < . , with . % of cases accurately classified. brexit view was a marginally significant predictor, b = . , se = . , p = . , or = . , % ci [ . , . ] and the other variables had a non-significant unique effect. there were no significant correlations between levels of behavioural compliance at t and brexit view (r = À. , p = . ), education levels (r = . , p = . ), income levels (r = . , p = . ), or perceived social status (r = . , p = . ). overall, this analysis suggests that these emerging attitude-based factions relate to existing rifts in society, both political and socio-economic. however, these groups cannot be reduced to any one category while still capturing divides in covid- behaviour. a bipartite network visualisation revealed factional attitudinal alignment emerging over time among uk participants sampled over a crucial -week period of the covid- pandemic. this method provides a straightforward and theoretically informed way to conceptualize and inductively identify opinion-based groups. these distinct attitudebased factions differed in behavioural compliance, suggesting that trust in science and health officials is a core basis for emerging covid- opinion-based groups. the observed factions partially reflect underlying societal divides, such as income and educational disparities. however, these do not explain discrepancies in health behaviour. instead, we observed a rapid emergence of factional consensus that did not obviously correspond to pre-existing identity frameworks. similar identity dynamics emerged around the 'brexit' referendum, when opinion-based groups rapidly coalesced across party lines, disrupting a relatively stable political system (hobolt, leeper, & tilley, ) . in contrast, other countries have seen health beliefs and behaviour coalesce along preexisting partisan lines (e.g., allcott et al., ) . practically, our results suggest directions for tailoring public health messages to maximize behavioural adherence (hunecke, et al., ) and avoid factional divergence. our analysis reveals an emerging basis for partisanship organized around trust or distrust of scientists and doctors. using bipartite attitude alignment to identity distinct clusters, we observe factional differences in behavioural compliance and clarity around the reasons for restriction. in other words, an identifiable group of people are not getting (or accepting) the message. we expect that the increasingly polarized opinion ecosystem makes it more likely that factions will respond differently to health messaging. our visualisation of the evolution of factions suggests that stakeholders should focus somewhat on rebuilding understanding of science, including the notion that scientists will often be wrong before they are right and that disagreements are a natural part of the scientific process. this may be especially important in the future when vaccine uptake may be a crucial factor in defeating the virus. in general, (at the time of data collection) people in the united kingdom trusted their communities and trusted vaccines. future research may explore the effectiveness of messages that emphasize how scientists are members of our community and how vaccine development helps them to protect our communities. importantly, although our t networks demonstrate schism, our t networks show a strong overlap in public health attitudes. we note that these processes are dynamic and our strongest practical recommendation is for opinion networks to be tracked over time before, during, and after health behaviour campaigns to assess the possible emergence of opinion-based groups that may undermine messaging or require different strategies. theoretically, we wish to make three points. first, shared attitudes are building blocks of identity (quayle, ) . even attitudes about public health can quickly coalesce into opinionbased factions. these rapidly emerging coalitions can become the basis for new emergent partisan identities. previous research suggests that identities can develop when people are motivated to communicate their attitudes towards social change, because they encounter a situation that contradicts their view of how the world should be (smith, thomas & mcgarty, ) . in the present study, it is easy to imagine how the rifts that opened in the public health opinion space in the early weeks of the covid- crisis might be co-opted by politicians, the media,orotheragentsinserviceoftheiridentityentrepreneurshipandpoliticalambitionsinthe months and years to come (reicher, haslam, & hopkins, ) . second, the coordination of opinions can become a basis for the coordination of action (mcgarty et al., ; smith, et al., ) as we have observed in the united states where republican dissatisfaction with lockdown has been expressed in dangerous public protests. this is not to say that the same would inevitably happen in the united kingdom; but rather that the emergent factional structures in the opinion space provide a starting point for such a social process to gather momentum. third, partisan polarization does not require extremism (fiorina & abrams, ) , which is why we refer to polarization as attitude coordination. the factional opinion structures identified in the present analysis are not easily detected with conventional linear methods, but are evident in the bipartite network visualisation and cluster analysis. this work further demonstrated the benefits of network analysis for understanding dynamic social psychological phenomenon (see abelson, ; brandt et al., ; dalege et al., ) . we have only limited evidence that the clusters we identify exist as psychological groups (turner, ) . given the emergent nature of this phenomenon, it was not possible for us to measure group identification ahead of time. rather, our research aims to track the emergence of a novel identity space (quayle, ) based upon an increasing alignment of shared public health attitudes. we assert that opposing clusters of shared opinions foster a readiness to define oneself and others with respect to a group identity in the future (bliuc et al., ) . indeed, the bipartite attitude networks we derive easily capture the presence of pre-existing political party membership with socio-economic attitude data. factional opinion coordination is dynamic and unpredictable yet it can have grave consequences for society. during a pandemic, when many must act collectively to protect the vulnerable few, it is important to maintain non-partisan solidarity in public health attitudes. we have presented a novel means of detecting factional attitude alignment, and the possible genesis of opposing opinion-based groups, that 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during the first week of the covid- pandemic in the united states new coronavirus polling shows americans are responding to the threat unevenly this research was funded from the european research council (erc) under the european union's horizon research and innovation programme (grant agreement no. ). all authors declare no conflict of interest. key: cord- -zb ih dl authors: chongsuvivatwong, virasakdi; phua, kai hong; yap, mui teng; pocock, nicola s; hashim, jamal h; chhem, rethy; wilopo, siswanto agus; lopez, alan d title: health and health-care systems in southeast asia: diversity and transitions date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: zb ih dl southeast asia is a region of enormous social, economic, and political diversity, both across and within countries, shaped by its history, geography, and position as a major crossroad of trade and the movement of goods and services. these factors have not only contributed to the disparate health status of the region's diverse populations, but also to the diverse nature of its health systems, which are at varying stages of evolution. rapid but inequitable socioeconomic development, coupled with differing rates of demographic and epidemiological transitions, have accentuated health disparities and posed great public health challenges for national health systems, particularly the control of emerging infectious diseases and the rise of non-communicable diseases within ageing populations. while novel forms of health care are evolving in the region, such as corporatised public health-care systems (government owned, but operating according to corporate principles and with private-sector participation) and financing mechanisms to achieve universal coverage, there are key lessons for health reforms and decentralisation. new challenges have emerged with rising trade in health services, migration of the health workforce, and medical tourism. juxtaposed between the emerging giant economies of china and india, countries of the region are attempting to forge a common regional identity, despite their diversity, to seek mutually acceptable and effective solutions to key regional health challenges. in this first paper in the lancet series on health in southeast asia, we present an overview of key demographic and epidemiological changes in the region, explore challenges facing health systems, and draw attention to the potential for regional collaboration in health. southeast asia consists of the ten independent countries located along the continental arcs and off shore archipelagos of asia-brunei, singapore, malaysia, thailand, the philippines, indonesia, vietnam, laos, cambodia, and myanmar (burma) (fi gure )-collectively known as the association of southeast asian nations (asean). the region contains more than half a billion people spread over highly diverse countries, from economic powerhouses like singapore to poorer economies such as laos, cambodia, • the diversity of geography and history, including social, cultural, and economic diff erences, have contributed to highly divergent health status and health systems across and within countries of southeast asia. • demographic transition is taking place at among the fastest rates compared with other regions of the world, whether in terms of fertility reductions, population ageing, and rural-to-urban migration. rapid epidemiological transition is also occurring, with the disease burden shifting from infectious to chronic diseases. • rapid urbanisation, population movement, and highdensity living raise concerns about newly emerging infectious diseases, but these outbreaks have stimulated regional cooperation in information exchange and improvement in disease surveillance systems. • southeast asia's peculiar geology contributes to it being the most disaster-prone region in the world, more susceptible to natural and man-made disasters aff ecting health, including earthquakes, typhoons, fl oods, and environmental pollution. climate change along with rapid economic development could exacerbate the spread of emerging infectious diseases. (continues on next column) (continued from previous column) • health systems in the region are a dynamic mix of public and private delivery and fi nancing, with new organisational forms such as corporatised public hospitals, and innovative service delivery responding to competitive private health-care markets and growing medical tourism. • the health-care systems are highly diverse, ranging from dominant tax-based fi nancing to social insurance and high out-of-pocket payments across the region. there is a greater push for universal coverage of the population, but more needs to be done to ensure access to health services for the poor. • private health expenditure is increasing relative to government expenditure, where new forms of fi nancing include user charges, improved targeting of subsidies, and greater cost recovery. health-care fi nancing could be further restructured in response to future demographic shifts in age-dependency, as in introduction of medical savings and social insurance for long-term care. • there is potential for greater public-private participation with economic growth through asean integration and further regional health collaboration, despite the current division of the region under two who regional offi ces. and myanmar (table) . [ ] [ ] [ ] [ ] [ ] [ ] [ ] by comparison with india and china, southeast asia is less visible in global politics and economics. the same is also true of global health. in the fi rst paper in this lancet series on health in southeast asia, we analyse the key demographic and epidemiological transitions of the region to delineate the challenges facing health systems and to emphasise potential for regional collaboration in health. this regional overview sets the scene for more detailed discussion of specifi c health issues presented in the fi ve subsequent reports in this series, profi ling maternal and child health, infectious diseases, non-communicable diseases, health workforce challenges, and health-care fi nancing reforms. southeast asia contains about million people, or % of the world's population, with indonesia having the largest population (and fourth largest in the world) and brunei the smallest (see table) . nearly half ( %) of the region's population live in urban areas, which is less than the world average, but there is much variation between countries, from % in cambodia to % in singapore. the region's average population density of people per km² also masks substantial intercountry and in some instances intracountry diff erences. population densities range from a low of people per km² in laos to a high of per km² in singapore. population densities in southeast asia's only two megacities, jakarta and manila, are much higher, at more than people per km². although their population sizes are similar (around million), the greater sprawl of manila and jakarta make them less densely populated (ranked th and th in the world) than mumbai and delhi (ranked st and th, respectively). the next largest city in southeast asia, bangkok, is ranked th. although urbanisation is expected to continue to rise in the region, urban slum populations seem to be less deprived than they are elsewhere, with about a quarter living in extreme shelter deprivation (defi ned by un habitat as a slum household lacking three or more of the following conditions: access to water, access to sanitation, access to secure tenure, a durable housing structure, and suffi cient living space). , although life expectancy in all countries in the region has improved, there have been signifi cant variations in the rate of progress. most countries have enjoyed continuous rises in life expectancy since the s, and these are converging. in some cases (myanmar, cambodia) political regimes and history of confl ict have aff ected progress, as has hiv in thailand (fi gure ). where life expectancy gains have slowed, this trend has been mainly attributable to slow progress in reduction of adult mortality. there has been little progress towards reduction of intercountry diff erence in life expectancy during the past years, with the gap remaining at around years. as elsewhere, decreased fertility has been the main factor contributing to ageing of the populations in these countries. the speed and timing of fertility reduction has varied widely across the region (webappendix p ). singapore had the earliest and sharpest reduction-the total fertility rate fell from more than six children per woman in to · in the mid- s, and since , it has ranked among countries with ultra-low fertility (table). thailand's fertility decrease mirrors that of singapore, although beginning somewhat later; it is currently the only other country in the region with we used quantitative and qualitative data from academic and grey literature to review the health situation in southeast asia. search terms used were "health", "health statistics", "health systems", "socio-economic development", and "southeast asia". data were gathered after a call for information from regional experts on selected subthemes related to health (geography, history, demography, epidemiology, and health systems rapid socioeconomic development and strong family planning programmes are likely to have driven this reduction. interestingly, this statement was true for indonesia, but less so for brunei and malaysia, although all three countries share a common dominant religion, islam. malaysia adopted a pronatalist policy in the late s under the then prime minister mahathir mohammad. catholicism has been a major contributing factor to the slow uptake of family planning programmes in the philippines, alongside the persistence of cultural norms that support large family sizes. the high fertility rates recorded in cambodia and laos are related to low educational levels, as refl ected in their low proportion of enrolment in secondary school- - % compared with - % elsewhere in the region (including % in vietnam). according to cleland, although literacy confers cognitive abilities to use contraception, the social and psychological skills conferred by higher education probably enable people to "translate the desire to postpone or limit childbearing into contraceptive practice… [and] they are also more likely to use allopathic health services for a range of needs including ante-and natal-care, child immunization and curative care [that lead to better child survival]". economic and demographic developments have prompted the movement of people across the region, mainly for short-term employment, but also for settlement. rapid economic growth and the slowing of domestic population and labour force growth due to fertility reduction have prompted countries such as singapore to open its doors to in-migration of foreigners at all skill levels for employment, with the option of permanent settlement for the highly skilled. the philippines, indonesia, and vietnam are major labour-exporters, whereas malaysia and thailand both receive and send nationals abroad. besides this internal labour market, countries in southeast asia also send and receive migrants from outside the region. since the s, however, destinations within asia have replaced labour migration to countries such as the usa and to the middle east. there is signifi cant undocumented or illegal migration as well as movement of displaced people in the region. , these groups are particularly vulnerable since "[u]ndocumented migrants are disproportionately more exposed to health risks due to inadequate working conditions and irregular movements, but are unlikely to seek medical attention because of their status, and are also often left out of assistance programmes in times of disasters and emergencies". population age structures of countries in the region vary widely as a result of past diff erences in fertility, mortality, and migration trends (fi gure ). these trends are in turn aff ected by economic, social, cultural, and political developments. singapore and thailand have among the fastest ageing populations in the world, with the proportion of elderly residents projected to double from % to % in and years, respectively-shorter than the years expected for japan - because of more rapid fertility reduction in these two countries. with increasing longevity, the pace of increase in numbers of the oldest old, aged years and older, in southeast asia is projected to exceed that of east asia over the period - . the other major factor contributing to population ageing has been the decrease in mortality. figure shows estimated trends in risk of child death (ie, between birth and age years) in countries of the region during the past four decades. child survival has improved substantially in all countries, but particularly in indonesia, vietnam, thailand, malaysia, brunei, and singapore, where the risk of child death is now typically less than about · %, compared with - % in the s. measured by the risk of dying between ages and years, regional diversity in levels of adult mortality is even greater than for child mortality (fi gure ). typically, the risk of dying at these ages for men is - %, and is higher ( %) in cambodia, laos, and myanmar ( - %), and signifi cantly lower in singapore, where the level is similar to those in australia and japan ( - %). this regional diversity in risk of adult death is similar for women, but with rates typically - % less than those for men. increasing longevity is a result of diminishing burden from communicable, maternal, and perinatal diseases (group diseases; webappendix p ), whereas countries with aged populations have a higher burden of noncommunicable diseases (group diseases). interestingly, mortality rates from these two groups of diseases, as well as from injuries, are correlated. countries with high mortality rates from communicable diseases also have high death rates from chronic diseases (webappendix p ). deaths from communicable diseases are still prominent in cambodia, myanmar, and laos. injuries are an important cause of death in all countries, but less so in singapore and brunei. few countries in the region have complete cause of death data systems to inform health policy and planning, and of those that do only singapore has reliable cause of death certifi cation and coding. although not representative of present health conditions in neighbouring countries, understanding of how leading causes of death have changed in singapore during the past years or so can provide important insights into what other countries of the region could expect to achieve, provided there is a similarly strong public health commitment to disease control and injury prevention. figure summarises trends in selected causes of death for both sexes in singapore since . in the early stages of transition, striking reductions in infectious diseases such as tuberculosis were achieved, off set by increases in non-communicable diseases including cardiovascular diseases and cancers, as well as injuries. although deaths due to road traffi c accidents have subsequently decreased and cardiovascular diseases seem to have reached a plateau, breast cancer has continued to rise. except for stomach and cervical cancer, mortality from all other cancers is still rising (data not shown). these data illustrate the success of singapore in reducing mortality from the diseases of poverty, as well as the eff ects of inadequate chronic disease control programmes, although there is evidence of some success in control of lifestyle-related diseases in recent years. as other countries in the region succeed in bringing communicable diseases under control, the importance of injury prevention and chronic disease control programmes will become increasingly pressing. the region as a whole does not have reliable longitudinal data for disease trends. however, evidence from studies of disease prevalence shows a strong inverse association with national wealth, which can be largely attributed to the social determinants of health, including the provision of more effi cient health systems with greater population coverage. the fi gure provided on p of the webappendix shows the relation between prevalence of tuberculosis and per head income (log-log scale). the regression equation (not shown) suggests that a doubling of per head income is associated with a reduction in tuberculosis prevalence of %. for diabetes mellitus prevalence, countries can be roughly divided into three groups that are positively correlated with income, although the eff ect tapers off at higher levels of per head income, (webappendix p ), possibly because of more eff ective disease control programmes with greater coverage. hiv was introduced into the region in the s. transmission peaked in the early s in thailand, followed by myanmar and cambodia. hiv/aids has been a major cause of death in some countries of the region (eg, thailand), although its spread has been partly controlled by the promotion of condom use. in the early s, more eff ective antiviral therapies emerged, followed by the introduction of compulsory licensing. although universal access to treatment has been attempted, patient compliance and losses to follow-up care are still prevalent. , aids mortality in southeast asia has stabilised since the mid- s, although prevalence remains high in myanmar, laos, and cambodia. the environment continues to be an important contributing factor to disease and mortality in the developing world, including countries in southeast asia, accounting for up to a quarter of all deaths. regular monsoons and typhoons occur in southeast asia. the el niño and la niña phenomena also intensify the annual variation of the hot and wet climate, leading to droughts, fl oods, and the occurrence of infectious diseases such as malaria and cholera. countries in the northern part of the region such as the philippines and vietnam are badly aff ected by seasonal typhoons that have increased in intensity over time. the philippines and indonesia are located on the pacifi c ring of fire, a zone of earthquakes and volcanoes where around % of the world's earthquakes occur. southeast asia is one of the most disaster-prone regions in the world; the indian ocean earthquake off the coast of sumatra in caused a devastating tsunami in aceh, indonesia, and countries on the fringe of the indian ocean, one of the worst natural disasters ever recorded. uncontrolled forest fi res raged in the indonesian states of kalimantan and sumatra in . the severity of the fi res was also closely linked to the occurrence of the el niño southern oscillation, which has historically brought severe drought conditions to southeast asia, creating conditions ripe for fi res. in , the severity and extent of haze pollution was unprecedented, aff ecting some million people across the region. the health-related cost of the haze was estimated to be us$ million. the health eff ects of the haze in southeast asia have been well documented. , an increase in concentration of particulate matter with diameter μm or less from μg/m³ to μg/m³ was signifi cantly associated with increases of % in upper respiratory tract illness, % in asthma, and % in rhinitis from public outpatient care facilities in singapore. time-series analyses in people admitted to hospital in kuching, malaysia, showed that signifi cant fi re-related increases occurred in respiratory hospital admissions for chronic obstructive pulmonary disease and asthma. survival analyses suggested that people older than years who had been previously admitted to hospital for cardio respiratory and respiratory diseases were signifi cantly more likely to be readmitted during the haze episode. climate change could exacerbate the spread of emerging infectious diseases in the region, especially vector-borne diseases linked to rises in temperature and rainfall. southeast asia has been identifi ed as a region that could be vulnerable to eff ects of climate change on health, because of large rainfall variability linked to the el niño and la niña oscillation, with attendant consequences for health systems. southeast asia's rich history and recent industrialisation and globalisation have raised new challenges for the region's health systems. modern medical technology is available in the world market but at costs higher than most of the region's population can aff ord. many traditional health practices persist alongside the use of new medical technologies and pharmaceutical products, presenting regulatory problems in terms of safety and quality. with increasing educational levels, ageing populations, and growing consciousness of human rights in the recently developing democratic environment, the demand for better care is increasing. health systems in the region face more serious adjustment problems than ever before. health services have become an important industry, with a mix of public and private non-profi t and for-profi t actors, along with the growth of trade and medical tourism. the provision, fi nancing, and regulatory functions of the public sector have to adapt accordingly to these transformations. the need to restructure healthcare delivery and fi nancing systems becomes crucial to balance new demand and supply equilibriums. , countries in southeast asia and their health system reforms can thus be categorised according to the stages of development of their health-care systems. a typology of common issues, challenges, and priorities are generated for the diverse mix of health systems of southeast asia at diff erent stages of socioeconomic development (see webappendix pp - ). the pressures placed on national health-care systems by the recent demographic and epidemiological transitions that we have described are amplifi ed by the growing demands of an increasingly educated and affl uent population for high quality health care and the supply of the latest medical technology. before the east asian fi nancial crisis in - and the recent global economic recession, an expanding middle class in the urban populations of the larger cities pushed their demand for high quality care into a booming private sector. as a result, market forces have turned many aspects of health care into a new industry in countries such as singapore, malaysia, and thailand, contributing to labour-force distortions for the production and distribution of health workers both within and across countries. the s began with the opening up of socialist states and rapid growth among market economies in the region. while they were each fi nding ways to reform their health systems, the asian fi nancial crisis in - posed more challenges for countries of the region. the depreciation of local currencies resulted in increased costs of imported drugs and other essential supplies, at the same time as access to basic health care was reduced for the most vulnerable population groups. however, reported spikes in suicides and mental illnesses in the other aff ected east asian economies such as south korea, taiwan, and hong kong were not as signifi cant in southeast asia. following the lessons learnt from the past fi nancial crisis, most countries have strengthened their social protection mechanisms and essential health services. there is a greater push among countries to increase universal coverage of basic health services, especially to vulnerable and disadvantaged populations. , throughout the region, many innovative pro-poor fi nancing schemes were implemented, such as the health card and -baht schemes in thailand, the health fund for the poor in vietnam, health equity funds in cambodia and laos, and, even in affl uent singapore, the medifund, a meanstested hospital fees subsidy scheme for indigent patients. so far, the health-care systems with dominant tax funding are fairly stable, in view of the strong role of governments and eff ective controls by health agencies to overcome inequity problems. however, crucial issues involve rising costs, future sustainability of centralised tax-fi nanced systems, effi ciency and quality of the public services, and higher public expectations. in both malaysia and singapore, the health-care systems are changing from government-dominated health services towards greater private-sector involvement. attempts to privatise public hospitals have been controversial, thus resulting in many hybrid forms of corporatised entities that continue to be controlled or subsidised by governments. [ ] [ ] [ ] [ ] some of the most innovative and advanced forms of publicprivate mix in health services have developed within the region, for example the restructuring or corporatisation of public hospitals in singapore from as early as and the later swadana (self-fi nancing) hospitals in indonesia. with the anticipated rise in the ageing population and future problems of intergenerational funding through pay-as-you-go mechanisms, there are experiments with new health-care fi nancing such as compulsory medical savings and social insurance for long term care. [ ] [ ] [ ] some countries such as the philippines, vietnam, and indonesia have radically decentralised their health-care systems with the devolution of health services to local governments, a restructuring that has aff ected aspects of systems performance and equity even though the impetus for cardiovascular diseases excluding rhd breast cancer tuberculosis road traffic accidents decentralisation was mainly political. consequently, to ensure increased fi nancial coverage and aff ordability, many governments have passed laws to establish national health insurance systems and mandated universal coverage, although implementation is problematic. with existing policies of decentralisation and liberalisation, equity issues and poor infrastructure will continue to challenge the development of the health sector. , the severe acute respiratory syndrome (sars) epidemic has emphasised the need to strengthen regional health collaboration. this cooper ation has occurred via two channels-direct bilateral collaboration by individual countries (ministries of health and foreign aff airs) and those under the aegis of asean. the mekong basin disease surveillance project is an example of successful health cooperation. it was established under the collective agreement of each ministry of health of member states of the greater mekong subregion to share important public health information. the emergence of infl uenza a h n and h n outbreaks has led to common eff orts to strengthen epidemiological surveillance and stockpiling of antiviral drugs. enthusiasm for regional economic collaboration continues to grow, evident from the explicit goal of the asean free trade area to increase the region's competitive advantage as a production base geared towards the world market. asean leaders have identifi ed health care as a priority sector for region-wide integration. from an economic perspective, opening of health-care markets promises substantial economic gains. at the same time, however, this process could also intensify existing challenges in promotion of equitable access to health care within countries. it could also lead to undesirable outcomes whereby only the better-off will receive benefi ts from the liberalisation of trade policy in health. health and trade policy can and do appear to contradict each other. tobacco use is the major preventable cause of non-communicable disease and death among the populations of asean countries. all asean members except indonesia have embraced the framework convention on tobacco control (fctc) and all countries endorse some form of tobacco control policy. however, most of these states are, to varying degrees, still involved in investment in or promotion of the tobacco industry, often using the justifi cation of poverty alleviation. there are clear contradictions inherent in the state seeking to prevent tobacco use in the interests of health, while actively promoting tobacco for the economic benefi t of its population, resulting in both substantial and symbolic harm to eff orts to implement the fctc. for example, tobacco production is legitimised; rational policy principles are violated, and direct cooperation between the state and multinational tobacco corporations is made possible by modifi cation of control policies. tobacco exports within asean also threaten the group's health solidarity. divestiture of state ownership of capital in tobacco corporations and a much stronger commitment by states to control the use and promotion of tobacco are urgently required in asean countries. issues of intellectual property rights surrounding products such as essential pharmaceutical drugs as public health goods are also of concern to countries. thailand started compulsory drug licensing in . indonesia has called for the urgent development of a new system for virus access and a fair and equitable sharing of the benefi ts arising from the use of the infl uenza virus in research (now commonly referred to as viral sovereignty). additionally, indonesia has pressed for the development of medical products to replace the existing patent system in global health governance. with globalisation, ensuring of accessible health services for citizens is no longer the sole responsibility of the state; health care in southeast asia is fast becoming an industry in the world market. the private sectors in singapore, thailand, and malaysia have capitalised on their comparative advantage to promote medical tourism and travel, combining health services for wealthy foreigners with recreational packages to boost consumption of such health services. patients from elsewhere, including the developed countries, are choosing to travel for medical treatment, which is perceived to be high quality and value for money. because of poor local economic conditions, the philippines had a policy to export human resources for health to the world and to richer countries in the region as an income-generating mechanism. although the fi nancial returns from this strategy seem substantial, equity issues have surfaced concerning the negative eff ects of international trade in health services and workforce migration on national health systems, especially in widening disparities in the rural-urban or public-private mix. regional collaboration in standards of data collection and health systems analysis is hampered by who's division of the asean region into two areas under separate regional offi ces: the south-east asia regional offi ce, encompassing indonesia, myanmar, and thailand, and the western pacifi c regional offi ce, consisting of the remaining countries. potential benefi ts from enhanced who regional cooperation include improved health surveillance, information-sharing, and health systems strengthening in all asean countries. southeast asia is a region characterised by much diversity, including public health challenges. social, political, and economic development during the past few decades has facilitated substantial health gains in some countries, and smaller changes in others. the geology of the region, making it highly susceptible to earthquakes and resultant tsunamis, along with seasonal typhoons and fl oods, further increases health risks to the population from natural disasters and longterm eff ects of climate change. public policy in these countries cannot ignore such risks to health, which could have important social and economic consequences. regional cooperation around disaster preparedness and in the surveillance of and health systems response to disease outbreaks has obvious advantages as a public health strategy. concomi tantly, all countries in the region are faced with large or looming chronic disease epidemics. even in the poorest populations of the region, non-communicable diseases already kill more people than do communicable, maternal, and perinatal conditions combined, with many of these deaths occurring before old age. greatly strengthened health promotion and disease prevention strategies are an urgent priority if the impressive health gains of the past few decades in most countries of the region are to be replicated. further growth and integration of the asean region should include as a priority enhanced regional cooperation in the health sector to share knowledge and rationalise health systems operations, leading to further public health gains for the region's diverse populations. all authors contributed to data collection, interpretation, writing, and revision of the report. we declare that we have no confl icts of interest. population division of the department of economic and social aff airs of the un secretariat maternal, neonatal, and child health in southeast asia: towards greater collaboration emerging infectious diseases in southeast asia: regional challenges to control the rise of chronic non-communicable diseases in southeast asia: time for action human resources for health in southeast asia: shortages, distributional challenges, and international trade in health services health-fi nancing reforms in southeast asia: challenges in achieving universal coverage neonatal, postneonatal, childhood, and under- mortality for countries, - : a systematic analysis of progress towards millennium development goal a systematic analysis of progress towards millennium development goal worldwide mortality in women and men aged - years from to : a systematic analysis world population prospects: the revision population database city mayors statistics. the largest cities in the world by land area human development and urbanisation state of the world's cities / : the millennium goals and urban sustainability ultra-low fertility in pacifi c asia: trends, causes and policy issues the global family planning revolution: three decades of policies and programs ethnicity and fertility diff erentials in peninsular malaysia: do policies matter? in: un department of economic and social aff airs population division. completing the fertility transition regional overview: east asia and the pacifi c education and future fertility trends, with special reference to mid-transitional countries. in: un department of economic and social aff airs population division. completing the fertility transition the future of labor migration in asia: patterns, issues, policies. research and seminars social policy in asean: the prospects for integrating migrant labour rights and protection social issues in the management of labour migration in asia and the pacifi c. un economic and social commission for asia and the pacifi c graphics bank: aging, speed of aging in selected countries population ageing and population decline: government views and policies. paper prepared for the expert group meeting on policy responses to population ageing and population decline the second demographic transition in asia? comparative analysis of the low fertility situation in east and south-east asian countries population ageing in east and southeast 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to lung function of haze from forest fi res: singapore's experience cardio respiratory hospitalizations associated with smoke exposure during the southeast asian forest fi res climate change and mosquito-borne disease impact of regional climate change on human health health impacts of rapid economic change in thailand comparative health care fi nancing systems, with special reference to east asian countries towards a comparative analysis of health systems reforms in the asia-pacifi c region east asian economic crisis on health and health care in indonesia was the economic crisis - responsible for rising suicide rates in east/southeast asia? a timetrend analysis for japan children and the economic crisis promoting health and equity: evidence, policy and actioncases from the western pacifi c region. manila, philippines: who western pacifi c regional offi ce privatization and restructuring of health services in singapore the growth of corporate private hospitals in malaysia: contradictions in health system pluralism constraints on the retreat from a welfare-oriented approach to public health care in malaysia the politics of privatization in the malaysian health care system innovations in health service delivery: the corporatization of public hospitals saving for health the savings approach to long term care fi nancing in singapore western pacifi c regional offi ce and south-east asia regional offi ce for who east asia decentralizes: making local government work south-east asia regional offi ce and western pacifi c regional offi ce for who measuring the accumulated hazards of smoking: global and regional estimates for global health, equity and the who framework convention on tobacco control the political economy of tobacco and poverty alleviation in southeast asia: contradictions in the role of the state the framework convention on tobacco control and health promotion: strengthening the ties pandemic infl uenza preparedness: sharing of infl uenza viruses and access to vaccines and other benefi ts this paper is part of a series funded by the china medical board, rockefeller foundation, and atlantic philanthropies. key: cord- -s l s authors: moyer, jeff title: a time of reflection: a time for change date: - - journal: agric human values doi: . /s - - -z sha: doc_id: cord_uid: s l s nan the world has come to a screeching halt. a global pandemic has shaken the foundation of life as we know it, and things may never be the same. and that can and should be a catalyst for change. we are presented with a unique opportunity to look critically at many of our society's systems and not only challenge them but challenge ourselves. societies are given few opportunities to reset their trajectory; we have been given such a chance. to simply suggest we return to "normal" will be to miss this opportunity. covid- has exposed the flaws and weaknesses in a broken food system that depends on high volumes of external inputs, long distance and international supply chains, and operates with a disregard for soil health and the health of those who consume the food. the health of people is intrinsically linked to the health of our soils. in , rodale institute founder j.i. rodale wrote some words on a blackboard. he wrote: "healthy soil = healthy food = healthy people," galvanizing the idea that our health and the health of soil are linked. over the decades that have followed, science has proven this to be true (steffan et al. ) . still, human health has not become a primary goal of agriculture. our current food system is most adept at producing low-cost, highly processed, hyperpalatable, nutrient-poor foods and commodities like wheat, corn, soy, and rice, many of which end up as livestock feed, ingredients for non-food uses, or refined and processed foods. agricultural intensification and consolidation have enabled the mass-scale production of inexpensive, low quality crop and animal products sacrificing our health. yet scientific research overwhelmingly supports the adoption of a diet high in nutrient-dense fruits, vegetables, grains, and livestock products (alonso et al. ; slavin and lloyd ) . simply put, our farming systems aren't aligned with what science has identified as the best foods for citizens to properly maintain health and rebuild our natural immune systems. the covid- pandemic has merely pointed out a problem that has been lurking on the sidelines for decades: our medical system is overburdened attempting to treat lifestyle-related diseases with pharmaceutical intervention rather than dietary and lifestyle changes, while farmers have never thought about human or soil health as the metrics by which they are judged. the fact that our soils are being depleted of the nutrients we need to sustain our health and regenerate our immune systems, and that the way we are farming is destroying the environment and ecosystems we need to survive, is not considered in conventional production. at the same time, our modern, conventional farming systems contribute up to a quarter of global greenhouse emissions and rely on toxic inputs that threaten our health, biodiversity, clean air and water, and our soil's long-term capacity to produce food-all of which ultimately jeopardize the future of human health and all of which can be mitigated by changing the model. regenerative organic agriculture, on the other hand, envisions a future in which farming, healthcare, and food production practices inform a prevention and intervention-based approach to human and planetary health. science conducted at rodale institute through long-term field trials shows that rather than relying on toxic chemicals to solve agricultural issues and pharmaceuticals to manage disease, a food system focused on soil health can help prevent disease (rodale institute ). by integrating our food production and healthcare systems, transitioning to a regenerative organic farming model, building in access to food that improves health rather than compromises it and emphasizing nutrition and lifestyle choices that prevent disease, we could radically change the system and take control of our health through farming. transitioning to a future based on regenerative organic agriculture is not without its challenges. new tools will need to be put to work, new protocols will need to be learned and new support policies will need to be put in place. but together, science, markets, and people can forge a new food production model that ensures local control and access, demanding that the long-term health of our soils and ecosystems be considered in the process and that our food production systems work to ensure our health. we need to encourage and support a conversation between soil scientists, medical practitioners, farmers, and food professionals that focuses on the health of the people we are charged with feeding and keeping healthy. if we take advantage of this opportunity for change and open the conversation in ways that foster innovation, with a goal of human health starting with the soil, together we will achieve a future that prioritizes health as the primary metric of agricultural success. the role of livestock products for nutrition in the first days of life the farming systems trial: celebrating years health benefits of fruits and vegetables the effect of soil health on human health: an overview key: cord- - h rcih authors: sharififar, simintaj; jahangiri, katayoun; zareiyan, armin; khoshvaghti, amir title: factors affecting hospital response in biological disasters: a qualitative study date: - - journal: med j islam repub iran doi: . /mjiri. . sha: doc_id: cord_uid: h rcih background: the fatal pandemics of infectious diseases and the possibility of using microorganisms as biological weapons are both rising worldwide. hospitals are vital organizations in response to biological disasters and have a crucial role in the treatment of patients. despite the advances in studies about hospital planning and performance during crises, there are no internationally accepted standards for hospital preparedness and disaster response. thus, this study was designed to explain the effective factors in hospital performance during biological disasters. methods: qualitative content analysis with conventional approach was used in the present study. the setting was ministry of health and related hospitals, and other relevant ministries responsible at the time of biologic events in islamic republic of iran (ir of iran) in . participants were experts, experienced individuals providing service in the field of biological disaster planning and response, policymakers in the ministry of health, and other related organizations and authorities responsible for the accreditation of hospitals in ir of iran. data were collected using semi-structured interviews in persian language. analysis was performed according to graneheim method. results: after analyzing interviews, extraction resulted in common codes, subcategories, and categories, which are as follow: detection; treatment and infection control; coordination, resources; training and exercises; communication and information system; construction; and planning and assessment. conclusion: hospital management in outbreaks of infectious diseases (intentional or unintentional) is complex and requires different actions than during natural disasters. in such disasters, readiness to respond and appropriate action is a multifaceted operation. in ir of iran, there have been few researches in the field of hospital preparation in biologic events, and the possibility of standardized assessment has be reduced due to lack of key skills in confronting biological events. it is hoped that the aggregated factors in the groups of this study can evaluate hospital performance more coherently. the deadly pandemics of infectious diseases are rising worldwide. in the twentieth century, have caused death of more than million people in many parts of the world ( ) . in the last relatively mild h n pandemic in , - of people were killed who were not necessarily in high-risk groups ( ) . according to the report of www.warontherocks.com, about cbrn events were reported between and ( ) . also, the possibility of using microorganisms as biological weapons is a real and increasing probability all around the world ( , ) . increasing the tendency to use biological weapons due to increased terrorist attacks, their relative convenience use, and low cost have led to many health concerns ( , ) . between and , - persons were killed in major terrorist incidents nearly every months ( ). hospitals are vital organizations during biological disasters and play a crucial role as a place of care and treatment for such patients ( , , ) . hospitals should have an essential role in biological disasters ( ) ( ) ( ) ( ) . having specialists and staff with knowledge and skills relevant to biological events can play a significant role in reducing mortality and morbidity in the community, especially in the first few hours, which is called the golden time. the result is hospital preparedness to deal with biological events, which improves the response rate and accelerates the process of rehabilitation ( ) . hospital services are differentiated from other institutions by their types of activities, resources, staff, multiple specializations, and equipment used ( ) . the response of hospitals has a multidimensional function (approach) ( , ) . despite the advances in studies about hospital planning and performance during crises, there are no internationally accepted standards for hospital preparedness and disaster response ( ) . to date, there has been no valid methodology for assessing the preparedness of hospitals for disasters ( ) . however, after the onset of disasters, it is necessary that hospitals be prepared to deal with the new circumstance and surge capacity ( , ) . disaster preparedness is recognized as one of the top priorities in the medical field ( ) . this process varies in cbrn events ( ) . according to the recommendation in the process of planning, preparing, and responding to disasters in the health system, it is necessary to use the "all-hazards" approach ( ) . however, in practice, this approach does not seem to be suitable for man-made and technologic disasters such as biological, chemical, or nuclear events. nevertheless, evaluating hospitals' performance during crises, especially the one caused by biological disasters (eg, the epidemic of diseases whether natural or intentional), is a topic that has been dealt with inadequately. since in the face of disasters and biological threats different conditions prevail in hospitals, thus, evaluating the performance of hospitals in such situations requires a different mechanism. in addition, no comprehensive plan has been developed to manage biological events in iran. therefore, the present study was conducted to identify factors affecting hospital response in biological disasters. qualitative content analysis with conventional approach was used in this study. the qualitative content analysis approach was used for subjective interpretations of text data by systematic classification process, coding, identifying categories, or patterns. using this approach, the researcher avoids classification with background thoughts and allows categories formation during the research process ( ) ( ) ( ) . hospitals under the supervision of ministry of health and other relevant ministries responding to biologic events in ir of iran at (including the defense ministry) were included in this study. participants in this project were experts, experienced individuals providing services in the field of biological disaster planning and response, policymakers in ministry of health, and other related organizations and authorities responsible for the accreditation of hospitals in ir of iran. data were collected through conducting semi-structured interviews in persian language with the aim of explaining factors affecting the performance of hospitals in response to biologic threats. initially, the researcher met each participant and presented the research goals and obtained their consent for participation. three participants did not respond to the request and introduced another person as an expert in the field of research. two participants stated that these questions were not in their field of expertise. a total of interviews were done. the age range of the participants was - years. the purpose of the interviews was to explain and explore the factors influencing hospital performance in response to biologic threats. interviews began with simple and general topics and went on to specific questions. some questions were changed during the research (after completing the third interview and analyzing the data). types of questions were as follow: open questions, based on the default, and case-by-case. some of the interview questions were as follow: . what are the effective factors in assessing hospital performance at the time of biological events? . what are the management problems that you have experienced or may experience during a biological threat? . what are the strengths and weaknesses in assessing a hospital's performance of biological threats? . what is the difference between assessing the performance of hospitals in natural disasters and in biological distasters? during the interview, the researcher observed and noted the participants' interactions with the environment and their reactions, which were considered in the data analysis. the number of participants was determined based on the saturation of the obtained codes, so that the new codes were not extracted by new interviews. sampling was done using purposeful and snowball method. the interview took about - minutes. at first, interviews were conducted with the participants, their voice was recorded, and transcription was done a short while after each interview. data analysis began after the first transcription. to analyze the data, the researcher studied the data deeply, reread, and considered the text of the interview, gained understanding of the data, and finally completed the analysis ( ) . after each interview, transcription was done and field observations notes were reviewed several times. the final text was approved by each participant (member check). after the third interview, the questions were redesigned. in this study, interviews and field notes were the analysis units. the texts were divided into content areas and meaning units. meaning units were summarized and codes were extracted. multiple codes were compared with each other in terms of differences and similarities; then, categories and subcategories were formed. the extracted categories were discussed by scholars; finally, the basic and essential meanings of the categories were edited. data collection continued until saturation was reached for each concept. in a qualitative research, rigor shows concepts of credibility, dependability, transferability, and different dimensions of trustworthiness ( ) . to achieve maximum credibility, the research team used a range of expert participants. participants were among authorities of health in ir of iran, officials and staff of biologic laboratories, and some experienced officials from civil and military organizations with a history of managing infectious disasters. after each interview, transcription of texts was performed in a short interval. interviews were listened repeatedly, and the researcher extracted the meaning units. then, based on the condensation and abstracting of meaning units, the codes were extracted. similar codes were placed in subcategories, and the categories were formed according to the similarities and differences between subcategories. in the case of extraction of codes, subcategories, and categories, expert opinions were taken from the research team, and agreement was reached among researchers, experts, and participants about the differences. this study has been conducted in the context of ir of iran. according to researchers' view, the results can be generalized to other countries, but the choice has been left to readers ( ) . this study was approved by the national committee of ethics of ir of iran (code number: ir.sbmu.retech. rec. . ). all participants were aware of the research objectives. informed consent was taken from all participants and their participation was kept confidential. all interviews were recorded with participants' permission and were fully transcribed within a short period after the interview. analysis was done simultaneously. the demographic characteristics of the participants are presented in table . participants answered all the questions during the interview. after analyzing interviews, codes were extracted. codes were categorized in subcategories after analysis. according to the similarities and differences in nature of subcategories, categories were extracted: detection; treatment and infection control; coordination; resources; training and exercises; communication and information system; construction; and planning and assessment. the graphic diagram of the extracted categories and subcategories is shown in figure . table contains extracted categories, subcategories, and common codes by content analysis. after analyzing the data, it was found that all participants considered the ability to detect biologic outbreaks or emergencies in hospitals as an effective factor in hospital performance. the first step in controlling a biologic emergency is to detect the event in a hospital. the subcategories of determining the type of event (intentional or unintentional) and early detection were extracted. - : according to the participants, the delay in diagnosis with subsequent possibility of developing outbreaks of communicable diseases could be a major factor in hospital performance. one of the participants (p ) mentioned, "rapid detection is an important factor in proper performance in biological disasters. in the crimean-congo fever epidemic, if diagnosis was not established on time, the disease would have spread further". - : determining the deliberate or unintentional cause of a biological event can affect hospital performance. in intentional events, the biologic agent may still exist in the environment which will cause the disaster to be continued. another participant (p ) said, "it is difficult to diagnose the cause of deliberate biological events because there is less experience about it. treatment has been discussed on the textbooks, but the bioterrorism detection has not reviewed extensively, and it is very difficult". from the participants' perspective, the ability to treat and control the infection in the hospital was considered as an important factor in the proper hospital performance in biological disasters. the obtained subcategories were as follow: the ability to manage the biologic event and treat patients; the ability to care for the patients; the ability to decontaminate the injured people and surfaces; the ability to perform biologic triage; and pre and post exposure prophylaxis in affected individuals. - : drug therapy of patients and pre and post exposure prophylaxis: the extracted common codes according to participants' interviews were possibility of appropriate response after a biological event in a hospital, prompt and suitable treatment of the patients, having an efficient team of rapid response, the ability to discharge if necessary, pharmaceuticals prescription, having adequate stockpiles, and the ability to perform pre and post exposure prophylaxis. one participant (p ) said, "if prevention is not imminent with different medications and appropriate vaccines, the disease would spread. for example, if respiratory anthrax or plague becomes prevalent, vaccination and appropriate therapeutic prophylaxis are the only way to prevent the disease progress in the community". - : nursing: the presence of skilled and capable nurses was one of the subcategories obtained in this study. nurses who are trained, skilled, and familiar with personal protective equipment may have positive effects on hospital performance. one of the participants (p ) mentioned: "having skilled nurses to care for infectious patients is valuable as patients' treatment in epidemics. one day i went to the hospital for a visit and saw the aids patient wearing a mask. the head-nurse had told him to do so". - : isolation: according to the participants, the ability to isolate patients with communicable diseases in the hospital and in the designated sites for group isolation was an important component of infection control. one participant (p ) said, "isolation spaces are needed based on the causative agent (such as droplet or airborne isolation). in emergency situations, metal partitioning is better, and if not possible, minimal isolation should be executed even with curtains". - decontamination: most participants considered the ability to decontaminate victims efficiently as one of the important factors in hospital performance dealing with biological disasters, which is an important step in decontaminating patients, surfaces, and equipment in proper response to such disasters. one of the participants (p ) stated, "environmental health authorities should be active in tackling the issue. notifications should be declared as soon as possible. environmental decontamination is needed for each disease". - : triage: according to participants, the use of specialized triage in biological events affecting many victims will enhance hospital performance. biological triage which has a different mechanism than other triage systems helps to reduce infection transmission and provide high-speed treatment for people with high-priority care. it also provides the most services in the least amount of time to the largest number of victims. one participant (p ) said, "all hospitals should have a triage system and special checklists." biological triage is necessary. there are no triage systems for infectious diseases in my hospital, so there is not any sorting during an outbreak". - : infection control: participants considered infection control as an essential criterion for hospital performance in biological disasters. the common codes derived from these subcategories are as follow: the ability to control infections during deliberate or natural biological outbreaks; the availability of preventive drugs at a predetermined time during an epidemic of communicable diseases; appropriate vaccination of people at risk; and the safety of hospitalized or outpatients patients in the outbreak of infectious diseases; and waste management. one participant (p ) stated, "to see how a hospital performs, we need to see how much patient's safety is considered. sometimes, with a simple maneuver such as washing hand, transmission of the infection would be prevented". participants considered inter-sectoral and intra-sectoral coordination as an important factor in the proper hospital performance during biological disasters. - : intra-sectorial coordination: a common subcategory was coordination and collaboration within the hospital during a biological disaster, including predetermined inter-organizational tasks. one participant (p ) said, "when epidemics occur, it is highly important that internal parts of the hospital (such as laboratory, radiology, emergency departments, and others) be coordinated. in the early days of influenza epidemic, we did not know where to send the patients' samples for definite diagnosis, which made the process more complicated". - : inter-sectorial coordination: the common codes in this subcategory were as follow: existence of memoranda between hospitals and partner centers (such as organizations for corpses burial, drug production companies, vaccines and personal protective equipment producers, reference laboratories, buildings' owners that can be used for mass storage or isolation). one of the participants (p ) stated, "if there is a suspicious anthrax case and the hospital is a regional one, they should know which laboratory would help, and there should be an accepted guideline for referral". according to participants' viewpoint, the availability of appropriate human resources, necessary equipment, appropriate physical structure, and enough funding has a beneficial effect on hospital performance in biological disasters. these subcategories created the category of resources. - : human resources: according to the participants' perspective, one of the most important factors affecting hospital performance was the availability of human resources in biological emergencies in terms of quality and quantity. defining an organized structure of the staff for the response, duty description for the team, the right staff, and an efficient manager in the hospital seemed necessary at the time of biological disasters. one participant (p ) said, "sometimes we have cases of flu, meningitis, and tuberculosis, but the hospital performance is not appropriate and practical. although training was provided and relative preparedness was expected, during the swine flu outbreak, all staff were afraid and wore masks in hospitals. even the staff in the infectious diseases ward wore masks, which was not necessary and only caused horror. only those who are within a meter of the patient should wear a mask". . : physical structure: based on participants' viewpoint, appropriate physical structure of hospitals to respond to biological disasters is an effective factor in dealing with biological disasters. the proper physical structure of a hospital, enough space for biologic triage, suitable isolation space considering the type of agent, a proper radiology and laboratory structure, and a standard lab were effective subcategories of this category. one participant (p ) said, "one of the performance evaluation factors is whether the hospital has been standardized; having a triage space and decontamination room before entering to the main ward and isolation from the emergency department are highly important. in the influenza epidemic, all hospitals were ordered to separate the patients upon arrival at hospitals, but this was not possible in some hospitals". - : equipment: the subcategories were equipping some ambulances ready for a biologic event, having special and practical equipment when dealing with biological disasters, adequate personal protective equipment, and the ability to maintain laboratory biosafety. one participant (p ) recommended, "having enough equipment to be able to provide good biosecurity is of significant importance. there is not a special stretcher for contagious patients in our hospital, and the lack of a special stretcher for carrying infected patients can impair performance". - : budget: according to the participants' opinion, allocation of appropriate budget for hospital was an effective factor in assessing the hospital performance during biological disasters. insurance of staff and the hospital, and proper allocation of funds were the common subcategories of this category. one of the participants (p ) said, "my hospital manager is concerned about the financial aspect, and he has limitations on training and recruiting human resources. we do not have financial resource even for equipment and training, and our managers do not believe in spending money for managing these disasters. they prefer to deal with tangible issues rather than intangible issues such as biological disasters that have not yet happened". training and exercise influence hospital performance. the subcategories were appropriate educational content in accordance with the up-to-date changes in the field and intermittent exercises. - : educational content: the following subcategories were extracted: having rich and up-to-date educational content with emphasis on biological group a & b agents; providing training on how to use personal protective and prevention equipment, triage, isolation, secure area, control, and treatment; and providing training for misbelief correction. one of the participants (p ) said, "there should be an educational content related to the subject; it can be a part of hospital accreditation. some employees even do not know the correct pronunciation of diseases". - : training: all participants considered staff training as one of the most important factors in hospital performance. the extracted subcategory was receive training in the field of biological agents, including continued and regular education, up-to-date training, and training about preventive and personal protective equipment (mask types and time), isolation types, triage, secure area, and group a & b agents. one participant (p ) recommended, "up-to-date training should be available for staff with an interval of maximum of up to year. our personnel have been graduated many years ago, and their training has not been updated at all". - : exercise: by analyzing the data, intermittent and proportional exercises were obtained as common codes in the exercise subcategory. according to participants, the factors of this subcategory included the need to conduct a biological exercise in the hospital, and presence of a range of exercises such as top table exercise for managers and coordinators and other types of exercises, and execution of intermittent drills within a specified time schedule. one of the participants (p ) declared, "our managers did not have any experience in biological disaster management, even in the form of a drill. we should exercise and learn what we lack". another participant (p ) said, "there should be an exercise index for evaluation (drills about personal protective equipment) ". according to the results of the data analysis, the risk communication system, information security, risk understanding, and surveillance system were subcategories of the communication and information system category. - : risk communication systems: having a risk communication system, information security, risk understanding, and a surveillance system were determined as subcategories of this category. - : information security: information security is important in an outbreak of infectious diseases in hospitals, as non-patients may go to the hospital for fear of panic or patients may not come to the hospital for fear of stigma. the common codes were as follow: the possibility of sending written reports or internal automation to senior officials, laboratories, and the ministry of health, and lack of public notification in some instances. one of the participants (p ) said, "a false outbreak would occur without proper communication with the economic authorities. each time after a rumor about an infectious disease, many will come to hospitals as false patients, and controlling such situations would be very difficult". - : risk understanding: this subcategory was also derived from the information and communication category. participants believed that developing a positive attitude towards the possibility of biological disasters in hospital managers is crucial, because if a manager or staff does not believe in the possibility of biological disasters, there would be no possibility of necessary and timely action. one participant (p ) declared, "hospital managers do not have a proper attitude about this kind of problems. even after being trained by senior officials, they still do not have a good perception of the biologic disasters". - : surveillance system: according to participants, the use of surveillance systems in hospitals and the active registration of infectious diseases were considered as effective factors in hospital performance. one participant (p ) said, "the center for diseases control of ministry of health has a tradition of its own. in the health sector, they have a disease expert who will inform you if something happens. they themselves do not actively seek out any disease". the existence of an appropriate hospital incident command system (hics) for biological events was one of the main obtained categories in this study. extracted categories were the need for existence of a code for the biological crisis, type of system activation, existence of a unique command, use of qualified advisors in a commanding system, and proper organization of the staff. one of the participants (p ) announced, "having an incident command plan during a biological disaster is highly important. commanding systems do not work well in our hospitals in important and dangerous disasters such as earthquake and floods". planning and assessment were among the other key elements that influenced hospital performance during emergencies. risk assessment in hospitals was identified as a basic point in evaluation of hospitals. in the absence of a risk assessment in a hospital, finding priorities for risk reduction measures can lead to resources loss and parallel work. participants considered the factors that impacted hospital performance: the existence of qualified self-assessment mechanisms along with appropriate indicators in assessment checklist and a well-defined cutoff point. extracted subcategories were existence of updated instructions and guidelines, a special response and recovery plan for biologic threats, using the all-hazards approach to preparedness, and a lab plan. another participant (p ) said, "readiness assessment checklist must be completed every - months for each center. our hospitals do not have any assessment checklist for infectious diseases". in this qualitative study, which was done using content analysis, the effective factors for hospital performance in biological emergencies in ir of iran were identified as follow: diagnosis; treatment and control of infection; resources; coordination; training and practice; communication and information systems; construction; and planning and assessment. detecting a biologic event is one of the primary influencing factors in hospital performance. early diagnosis is one of the important factors for initiating immediate action and response to prevent further development of a biological agent ( ) . controlling hospital outbreaks requires rapid diagnosis and search for clusters; then, appropriate controls are executed ( ) . early diagnosis of the disease prevents its spread and can be effective in the timely treatment of exposed individuals and doing biologic triage. while an epidemic is rapidly discovered, its spread can be prevented by isolating patients and prompt prophylaxis. also, recognizing the type of biological disaster (intentional or unintentional) aspect may have an impact on hospital function because management of such biological emergencies may en-counter many complications considering type of agent, genomic manipulation, event location, geological and climatic conditions, and disease spread in the community prior to definitive diagnosis ( ) . over the past decades, the intentional enhancement of using biological agents has increased the demand for risk assessment and monitoring of such events, which often involves modeling approaches based on certain assumptions such as the ability to generate, store, and distribute. the ability to release a biological agent as a weapon does not only result in the creation of airborne transmissible microorganisms but can be transmitted from human to human and spread. management of deliberate transmissible is different from that of non-transmissible epidemics ( ) . another effective factor in hospital performance in biological events is treatment and infection control. in a biologic emergency, treatment measures and timely response to the event are important factors. triage is an important factor in controlling hospital infection during a biological emergency ( ) . most triage systems deal with traumatic or kinetic injuries ( ) . such systems are not applicable to other types of disasters, including biologic emergencies, because some factors (eg, exposure and symptoms) do not affect the infection control and make rapid diagnosis and treatment more difficult. victims are unlikely to be harmed, and there may not be a particular scene of disaster ( ) . therefore, it is necessary to consider a special system of triage instead of conventional systems ( ) . in accordance with burkle's recommended method, biologic triage is used for patients in an incident with a large number of injured people and divides them into groups: ( ) susceptible but not exposed; ( ) exposed but not yet infectious; ( ) infectious; ( ) removed by death or recovery; and ( ) protected by vaccination or prophylactic medication ( ) . in settings where infectious diseases are easily transmitted, deaths from infectious diseases are more likely than traumatic events ( ) . therefore, applying biologic triage is vital for controlling transmission. during biologic emergencies, triage makes it easier to control and treat the patients, prevents loss of resources, and reduces the probability of transmission of communicable diseases, and decreases the burden of hospitalization by reducing the number of visits to hospitals ( , ) . in this regard, access to drug and vaccine supplies and appropriate measures can reduce the number of patients or decrease the disease severity. effective actions in performance are hand washing and self-protection methods for staff, and proper isolation based on the type of disease ( , ) . providing care for patients within the hospital is an important part of patients' treatment and infection control at treatment centers ( ) . therefore, having competent nurses and trained infection control specialists as well as self-protection methods are other measures related to performance improvement ( ) ( ) ( ) ( ) ( ) . in biologic emergencies, one means of differentiation with other common emergencies is the need for self-protection methods of staff, especially physicians and nurses who have close contact with the patients ( , priate measures stops the transmission of the infection between patients and staff, including nurses ( , , , ( ) ( ) ( ) ( ) ( ) ( ) . decontamination spaces of biological patients will make these disasters distinct from others. decontamination is less important in disasters with large number of traumatic patients, but in biological disasters (especially man-made), the entry of noncontaminated patients into hospitals and the implementation of individualized and collective quarantine are of great importance ( , , ) . risk management approaches for infectious disasters are necessary to reduce the risk of secondary contamination with regards to decontamination measures and surveillance ( ) . based on the results of this study, human and financial resources, physical structures of hospitals, and equipment (including personal protective equipment, laboratory, appropriate vaccine, and antibiotics) are effective factors in the proper functioning of hospitals. these findings were consistent with those of other studies ( , ( ) ( ) ( ) ( ) . an appropriate response requires access to laboratory facilities ( ) . decontamination facilities and access to personal protective equipment for triage and decontamination teams are among the limitations of performance in biological events ( , , ) . adequate budget is usually not allocated due to the high cost of preparedness and performance measures in infectious disasters. several studies have shown that the number of public health staff may decrease at the time of biological disasters (such as flu pandemics) ( ) ( ) ( ) . typically, volunteers will meet the required human resources (efficient and trained personnel) in disasters ( , ) ; however, this would not be the case in biological disasters. although the amount of motivation to work during biological disasters varies from country to country, the total amount of motivation is lower than in other events ( , ) . this drop in staff motivation is also evident in the number of volunteers ( ) . however, more research is needed to study the willingness of public health staff in disasters ( ) . therefore, one of the most important factors in biological disasters is the provision and management of manpower required in hospitals. previous studies have shown that male gender, being a physician, having a full-time job, self-protection, and communication equipment for staff, and basic needs such as water have a positive impact on the willingness to work in such events ( , , ) . motivation facilitators for working in infectious emergencies include access to vaccination and personal protective equipment, flexible work shift, taking care of staff children, and information sharing ( ) . regarding the release of a biologic agent, the strategic storage of the vaccines as well as pharmaceuticals for treatment of the agent can be important because easy access to antibiotics and vaccines is very effective. access to ventilators for the management of infectious respiratory disasters is a necessity ( , ) . there are currently antiviral drug storages for responding epidemics that cost a lot ( ) . the lack of funding and financial resources is a major obstacle to the preparedness and proper performance in infectious disasters ( , ) . appropriate supply strategies, adaptation to the severity of the event, and the type of microorganism have a preventive and controlling role in infection from person to person ( , ) . also, having a proper physical structure to respond to biological events is important for proper functioning. this factor has been mentioned in numerous articles ( ) ( ) ( ) ( ) . examples which may be presented here are the existence of a separate entrance door for the emergency department, proper design of the rooms and the hospital, and proper equipment (eg, separate ventilators in the emergency department) ( ) . based on the findings of this study, staff training was one of the main elements of the proper functioning of hospitals in biological events. reviewing articles also indicated that education and training are key elements in disaster preparedness ( , ) . many efforts have been made to explain the capabilities and design of training curricula for management and response to cbrne events, but there is still lack of capability-based plans ( ). emergency department physicians, nurses, and support staff are the main groups for training and education. hospitals will not be able to respond appropriately in disasters without the upgraded educational guides ( ) . training is an important challenge in managing disasters which was obvious in events such as ebola outbreak. control of communicable diseases such as ebola and other infections may be affected by lack of educational materials, curricula (educational curriculum, development of educational contents, training resources, and tools), and educational contents ( ) . most of training courses (during and after ebola epidemic) have been performed for infection control staff and has not been addressed for other stakeholders ( ) . best practices for ebola education are engaging all stakeholders (eg, crisis managers, infectious disease control staff, and health workers) in educational programs. the most important educational challenges are annual budget and misdeclaration of sufficient training in an organization ( , ) . sustained education for combating the spread of infectious diseases requires annual budget, full support of the organization management, and engaging all stakeholders ( ) . the reports show poor knowledge about disaster planning and biological events in emergency departments around the world ( , , ) . it is imperative to ensure full recognition of risk reduction plans in infectious disasters for all those responsible for reducing the risk. in an egyptian study, medical residents had less training on personal protective equipment than specialists and counselors ( ) . however, education in this regard is one of the key points in infection transmission and control. occupational and non-occupational stresses in physicians were more than nurses, indicating the need for further training on the nature of pandemics, the results, complications, and methods of infection prevention ( , ) . in the absence of comprehensive support and failure to address the motivation or needs of professionals, effective education and the use of educational opportunities would be a challenge ( ) . developing educational standards and guidelines for a medical response to disasters (especially cbrn) has a major impact on emergency response to disasters ( content, determining the type of training, and evaluation of tools. a review article of cbrne training courses between - indicated that course evaluation was not done by any study ( ) . essential elements of education are personal protective training, hospital incident commanding systems for emergencies, surge capacity, and assessment and risk determination in accordance with biological disasters ( ) . coordination is one of the disaster management requirements in communities and hospitals. disaster management occurs in a complex context. this complexity is the result of a variety of different functions of the external and internal sectors in a hospital. coordination of these sectors would result in proper disaster management. in this study, internal and external coordination were key factors in response to biologic disasters. the presence of the emergency coordinator promotes health sector preparation activities. coordinators also provide a road map for moving in and out of hospital-crisis-related factors. avery et al indicated that the presence of a coordinator increases the level of readiness in the health sector in a disaster ( ) . this is evident especially in infectious disasters which require more coordination between infectious disease control centers and security sectors. jones et al showed that the coordinator had a direct relationship with the readiness of hospitals in pandemics. the connection was not linked to readiness in other settings such as casualty incidents, general preparedness of the hospital, and inefficiency of the hospital infrastructure. this could be a sign of the difference in infectious disasters. management requirements of such events include provision of vaccines, drugs, and personal protective equipment, and sufficient equipment and personnel resources at local, national, and international levels. memoranda of agreements (moas), memoranda of understanding (mous), and planning partnerships with other hospitals, health centers, government, local authorities, and other providers of support services are examples of out of organization coordination ( ) . capability of hospital external evacuation also requires external organization coordination, which according to the review of articles in the field of interhospital memoranda, has the lowest rate for children and infants ( ) . risk communication is one of the central components of proper performance of hospitals during infectious disasters ( ) . communications and information systems were derived as one of the main categories in this study. when an outbreak occurs and general public health is compromised, direct interventions and treatment options may be limited due to lack of time and the need for resources. therefore, communication, notification, and guidance are often the most important tools of public health in risk management during such events ( ) . communication readiness reduces the response time of the crisis ( ) . other impacts of communication and information systems during disasters are confidence of people in managers and acceptance of protective behaviors, disease surveillance, and reduction of confusion ( ) . to effectively respond, information should be organized in a timely fashion and be disseminated through multiple channels along with appropriate training ( ) . health communication includes key elements: message, receiver, source of information, and the channel for information exchange. the above elements should exist and function properly in any health-related communication plan. communication would be implemented in the field of informing the public as well as in health systems, especially with respect to infectious disasters ( ) . public health stakeholders, although not directly involved in public health emergency management, will take timely decisions, plan, and control timely access to information ( ) . moreover, to effectively implement communication in these disasters, standardized educational content, clear national guidelines, and pre-prepared plans in the field of communication in hospitals are required ( ) . ineffective communication is one of the potential reasons for the failure of infection control in health workers ( ) . hospital communications should be completely clear, scientific, and understandable. health workers are an important criterion for community's trust in resources and their knowledge and dealing with the situation will affect the trust of the community ( ). bonneux et al suggest that the management of unpredictable panic of hospital staff is more difficult than controlling the spread of disease ( ) . the clear release of information can prevent the fear of staff and society ( ) , and a long negative impact will occur with no on time intervention on hospital performance ( ) . understanding the proper risk from leading risk is a decisive factor in disaster management. today, in a world where the information transfer (whether right or wrong) is done at a rapid pace, the perception of risk from truly risky cases is less than estimated, and the risk of rare cases is overestimated ( ) . understanding the risk is related to the mental sensation of control. the threat of an epidemic may in part be frightening because of feeling lack of control that leads to an unwanted activity ( ) . verbal communication and standard communications (eg, guidelines, education, electronic communications, and marketing) are definitive communication pathways in infectious disasters. experiences indicate that traditional methods are unsuccessful in changing and maintaining the best performance in infection control, although newer methods (such as electronic communications and marketing) have some problems. some approaches (eg, involving health staff in the communication processes or up-down communication) can improve communication methods ( ) . the timely identification of cases of infectious diseases with increased patients over a given period of time is a critical necessity for the ipcs. survival systems in hospitals are currently focusing on a small set of microorganisms such as methicillin-resistant staphylococcus aureus, carbapenem-resistant enterobacteriaceae, and clostridium difficile ( ) . there are several pathways for the transmission of pathogens (staff to patient, environment to patient, patient to patient, visitors to patient, etc.) due to dynamic health care in hospitals. better monitoring of the epidemics onset would be implemented by operating the modern and multifunctional surveillance systems, including observing symptom reports in specific time spots, syndromic surveillance systems, prediagnosis and nonspecific criteria monitoring, and health behaviors observation (eg, absenteeism from work or school, pharmacy referral or even search rate in search engines with specific words that indicate an increase in the incidence of infectious diseases) ( ) . although more modern systems such as electronic surveillance systems have high sensitivity, their positive predictive value is low ( ) . united states has conducted surveillance systems and epidemiological surveillance with a large budget in the framework of biowatch program to monitor the deliberate propagation of biological agents ( ) . in this study, an incident management commanding structure in accordance with biological emergencies was found to be the proper structure of the main element of performance. hospital incident command systems are used as a model for disaster response in some countries. this system is an attempt for standard performance of hospitals in disasters ( , ) . in recent years, incident command system has been implemented for iranian hospitals to manage disasters with an all-hazards approach ( ) . application of this system is part of the requirements for the accreditation of hospitals in ir of iran. however, this system has limitations such as not addressing the vulnerability of hospitals and not assessing the hospital performance in disasters ( ) . the participants considered the incident command system (consistent with biological events) as an effective element of hospital performance in biological events. use of the incident command system is part of an appropriate response to cbrn events ( , ) . the hospital incident commanding system is an integrated structure that despite the volume and effects of the events can provide coordination, control, operations, planning, support, and other necessary functions for event management, if properly implemented. it also explains responsibilities clearly leading to appropriate response ( ) . the effectiveness of this system has been indicated in outbreaks of infectious diseases ( , ) . if the response to biological emergencies will be designed as a systematic approach, it would lead to faster response by establishing coordination, speed of communication, recalling staff, etc. ( ) . this adaptation could include selection of specialized infectious and epidemiologic consultants, proper planning, operations based on infection control requirements, treatment and care, and other requirements for managing biological crises. in addition, matching these systems with biological emergencies can speed up the response by increasing external and intra-organizational coordination of multiagent organs ( ) . planning was one of our extracted main categories. the existence of disaster management plans in hospitals is essential to ensure preparedness and response, even before the emergence of events. a disaster management plan is a set of procedures, policies, interactional patterns, roles, and contingencies which are developed to prepare and implement appropriate response to a crisis ( ) . this plan includes staff training plans, responding to potential biologic agents, pollution prevention, rapid communication plans, potential quarantine exposure (individual and group), resource production and planning, and rapid diagnostic plans ( , ) . the existence of evidence-based guidelines is one of the deficiencies in infection control in iranian hospitals. self-assessment, external evaluation, and the use of intra-organizational and external experts for scientific review of guidelines and plans can have a positive effect on improving hospital performance. however, performance evaluation can be assessed in real terms after disasters and from lessons learned ( ) . security issues affecting the health and national systems and context of intentional biologic events were limitations of the present study, which did not allow all selected managers to participate in the study. however, the limitation was resolved by continuing the interviews with the main managers, determining the alternative ones, and continuing the interviews until saturation. hospital management in outbreaks of infectious diseases (intentional or unintentional) is complex and requires different planning than natural disasters such as earthquakes, floods, etc. in such disasters, readiness to respond and appropriate action is a multifaceted operation that has not been addressed in ir of iran and other countries so far. in this study, the factors affecting performance in such events were qualitatively explained and categorized. also, to properly perform in such disasters, each of the categories and their subcategories should be carefully implemented with 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learned from implementing an incident command system during a local multiagency response to a legionnaires' disease cluster in sydney sars and the hospital emergency incident command system (heics): outbreak management as the mother of invention we would like to thank all of participants who spent their valuable time for interviews and other surveys. all authors disclose that there is not any actual or potential conflict of interest, including any financial, personal, or other relationships with relevant authorities or organizations within years of starting the study. key: cord- -fis xbi authors: chowdhury, rajiv; van daalen, kim r.; franco, oscar h. title: cardiometabolic health: key in reducing adverse covid- outcomes date: - - journal: global heart doi: . /gh. sha: doc_id: cord_uid: fis xbi whilst current public health measures focused on good hygiene practices and limiting person-to-person transmission contribute effectively in managing the covid- pandemic, they will not prevent all individuals from becoming infected. thus, it is of importance to explore what individuals could do to mitigate adverse outcomes. the value of beneficial health behaviours and a healthy lifestyle to improve immune functioning and lower adverse consequences of covid- are increasingly being emphasized. here we discuss seven key health behaviours and corresponding recommendations that may assist in reducing unfavourable covid- outcomes. the novel coronavirus disease (covid- ) has been declared a public health emergency of international concern with more than million confirmed cases [ ] . without effective treatment or vaccines, strategies to control covid- are focused on non-pharmaceutical interventions such as good hygiene practices and limiting person-to-person transmission. whilst these measures contribute effectively in managing the pandemic, they will not prevent all individuals from becoming infected. this is particularly relevant as it is unclear for how long preventive measures can be maintained, especially in low-and middle-income countries (lmics), and as several countries may prematurely be easing restrictions triggering secondary peaks in covid- cases. thus, it is of importance to explore what individuals could do to mitigate adverse outcomes. importantly, people with a weakened immune system or cardiorespiratory functioning are more likely to be infected with pathogens and develop complications. accordingly, disproportionately high case-severity and case-fatality among elderly and individuals with pre-existing conditions, including cardiovascular disease, are observed among covid- patients. this is also observed in relatively younger patients with comorbid conditions or detrimental risk profiles -population characteristics common in many low-income populations [ ] . similar findings have been found during other epidemics and pandemics. for example, age and comorbidities (e.g., diabetes, cvd) were consistently found to be independent significant predictors of adverse outcomes in viruses impacting the respiratory system such as sars [ , , ] , mers [ ] , and h n influenza [ ] . consequently, the value of beneficial, healthy behaviours and lifestyle to improve immune functioning and lower adverse consequences of covid- are increasingly being emphasized. here we discuss seven key health behaviours that may assist in reducing unfavourable covid- outcomes whilst having important co-beneficial impacts on non-communicable disease prevention (figure ) . first, regulation of cardiometabolic disease. cardiometabolic comorbidities are associated with adverse covid- outcomes. however, many patients with hypertension or diabetes mellitus, especially in resourcepoor countries, demonstrate poor adherence to essential medications [ ] . furthermore, as it was suggested that ace inhibitors and angiotensin receptor blockers have potentially harmful effects on covid- outcome, individuals have been discontinuing treatments. yet, thus far, no studies recommend discontinuing or altering treatment. clinical societies strongly recommend individuals with a known history of the cardiometabolic disease to regulate their blood pressure and/or glucose levels by continuing prescribed treatments including, e.g., glucose self-checks and taking medications [ ] . second, the discontinuation of smoking. whilst smoking remains one of the most important preventable risk factors for premature death, recent evidence suggests a lack of association between smoking and adverse covid- outcome [ ] . this could partly be explained by high case-fatality among elderly patients with multiple comorbidities tending to be non-or former smokers due health reasons. nonetheless, smoking results in comorbidities that have been associated with poor covid- outcomes, including cardiac events. furthermore, smoking is known to be associated with viral infections and severity (e.g., influenza) as smokers are more likely to have poorer lung function/capacity [ ] , contract microbial diseases (through structural changes in the respiratory tract, decreased immunity) [ ] , and perform repetitive hand-to-mouth movements. considering this, recommendations advocate for an immediate cessation of smoking habits to prevent detrimental covid- consequences. third, a healthy, balanced diet. nutrition and hydration remain cornerstones for optimal health. various micro-and macro-nutrients play potentially crucial roles in immunity [ ] (e.g., zinc regulates cell division [ ] , vitamin d is needed for natural killer cell function [ ] , and arginine is essential for nitric oxide generation by macrophages [ ] ), whilst deficiencies and prolonged undernutrition impair immune function [ ] . hence balanced rich in whole foods, fresh vegetables, fruits, legumes, nuts, whole grains, adequate hydration, and are low in sugar and salt are recommended [ ] . additionally, some evidence suggests that nutritional supplements might be beneficial in preventing acute respiratory tract infections and adverse outcomes, including covid- . for example, it has been recommended for people at risk of influenza and/or covid- to consider taking , iu/d of vitamin d for a few weeks to raise (oh)d concentrations, followed by iu/d [ ] . furthermore, supplementation of vitamin a, d, zinc, selenium, as well as the use of several nutraceuticals and probiotics may be able to enhance the prevention and treatment of covid infections [ ] . however, appropriate caution should be taken to avoid the potential risk of overdose, and natural food sources are preferred. those at risk of malnutrition or those malnourished should take extra precautionary care, ideally assisted by a trained dietician [ ] . fourth, safe physical exercise. regular physical activity or exercise improves immune regulation whilst delaying and decreasing the incidence of infections and non-communicable diseases (e.g., cancer, cvd, chronic inflammatory disorders) [ ] . furthermore, it stimulates healthy aging by reducing risk on elements of frailty (e.g., impaired mobility), sarcopenia, and dementia [ ] . acute exercise (moderate-to-vigorous, up to min/day) is considered as important immunoregulator, supporting optimal exchanges of distinct, highly active immune cell subtypes between tissues and circulation [ ] . nevertheless, prolonged homestays result in increased sedentary behaviour and lack of physical activity, leading to chronic health conditions, anxiety, and lower immunity. it is therefore advised to keep physically active, whilst following safety precautions. there is a plethora of ways to keep physically active. examples recommended, but are not limited to, include: ) using household chores to be active (e.g., cleaning tasks), ) freehand exercises at home, ) joining online exercise classes, ) muscle-strengthening activities if feasible, and ) indoor playground games for children [ ] . a multicomponent exercise program (aerobic resistance, balance, coordination, and mobility training) is considered most adequate for older people [ ] . it is imperative that all safety precautions and infection control measures should be followed when undertaking any form of physical exercise at or around the home [ ] . for instance, the right activity should be chosen to maintain physical distancing, reduce the risk of injury, and exercise should be avoided if there is a symptom (e.g., fever, cough or breathing difficulty). furthermore, public gyms or pools are best avoided. fifth, minimize stress. physiological stress may increase susceptibility to communicable diseases (including respiratory infections) due to compromised immunity and increased inflammatory reactivity resulting from, e.g., modulation of the hypothalamic-pituitary-adrenal axis in response to stress [ ] . such negative impacts of stress [ , ] on infection and immunity are very pertinent to the covid- pandemic, as entire communities are now in lockdown, the economic future is uncertain, and people are deeply concerned about the health and wellbeing of themselves and their loved ones. furthermore, large scale disasters are almost always accompanied by increases in depression, posttraumatic stress disorder, substance use disorders, domestic violence, and a range of other mental health impacts [ ] . worryingly, a significant negative association appears to exist in people with psychological stress and their antibody responses to influenza vaccination [ ] . reducing, psychosocial stress might be beneficial to successfully fight off covid- . several proactive measures to minimize the effects of stress are recommended: ) develop and implement a routine to ensure continuity and structure, ) take breaks from reading or listening to distressing news (or misinformation) that are circulating through social or other media, ) seek information only from credible sources; ) talk to your family members living in the house; ) if you live alone, tackle loneliness and its sequalae by e.g. the use of digital technologies, ) embrace relaxation techniques such as meditation or prayers; ) keep yourself occupied with activities that you enjoy [ , ] . sixth, maintaining adequate sleep. sleep is essential to health and effective immune functioning (e.g., modulation cytokines levels, cell subpopulations) [ , ] . conversely, sleep deprivation, and rapid eye movement sleep deprivation can weaken immunity and increase susceptibility to viral infections [ ] . this has previously been shown for e.g., influenza virus [ ] . furthermore, sleep heightens mood and optimizes energy levels [ ] , and sleep improves overall brain function and mental health (e.g., reducing stress and anxiety) [ ] . therefore, while no direct evidence on sleep deprivation and the risk of adverse covid- outcomes currently exist, it seems reasonable that consistent, high-quality sleep may be immune-supportive. recommendations include: ) set a consistent sleep schedule by fixing the bedtime and wake-up times, ) maintain good duration of sleep ( - hours/day), ) avoid day-time naps which may affect night-time sleep, ) open windows/blinds to ensure natural light exposure, which supports circadian rhythm, ) reserve your bed for sleeping (do not 'work-from-bed'), ) limit the exposure to digital screens specially before sleep [ ] . seventh, reducing high alcohol intake. this march, various people died after drinking industrial-strength alcohol, based on a false belief that it would protect them from covid- . inversely, associations with heavy alcohol drinking and adverse infection outcome have been reported throughout history. epidemiological studies found associations between alcohol abuse and viral infections, including hiv-aids [ ] , hepatitis c [ ] , and community-acquired pneumonia [ ] . excess alcohol disrupts adaptive immunity by affecting t lymphocytes balance, t-cell functioning, and peripheral b cells [ ] . reducing high alcohol intake may be favourable for covid- susceptibility and outcomes. in line with the world health organization guidelines, it is recommended that alcohol intake should be eliminated or only be consumed in moderation. also, those who do not drink alcohol should not start drinking [ ] . although these recommendations could improve immune function and overall health, implementation faces challenges. first, behaviour has proven difficult to change, even after facing detrimental disease, and it is unclear whether covid- concerns would suffice to motivate individuals to change behaviour [ ] . second, built and physical environment can limit health behaviour implementation. to illustrate, people living in food deserts, with limited access to healthy foods, often have high caloric diets low in nutritional value. poor urban planning (e.g., limited infrastructure compactness) and overcrowding can lead to lower means to do physical activity [ ] . third, food availability and access to food (especially fresh foods) may be limited. fourth, prevention and treatment services have been severely disrupted. hence, medication availability might be affected by lockdown measures and the concentration of healthcare systems on pandemic management, limiting medication adherence. furthermore, many populations already have poor access to effective, equitable healthcare, including cardiometabolic medications. finally, inequalities in economic, cultural, and social resources my shape inequalities in abilities to adapt health behaviours, having potential to exacerbate health inequalities [ ] . this is particularly problematic as pandemics are most destructive in vulnerable populations. while being conscious of implementation challenges, proposed actions provide guidance on health behaviours improving immune and cardiorespiratory function that may reduce adverse covid- outcomes. however, it should be noted that concerted efforts through multilateral cooperation and integrative efforts, including consideration of the social and environmental factors of inequalities and societal solidarity are essential to facilitate their effective implementation. this includes, for example, ensuring mechanisms in place for reporting and intervention of domestic violence and mental health system preparation for the inevitable consequences precipitated by the pandemic [ ] . short-term and long-term benefits of a healthy lifestyle may be enormous and expand beyond the current pandemic, benefiting individual, societal and planetary health. there has been no funding allocated to this project. kim van daalen received a scholarship funded by gates cambridge. the authors have no competing interests to declare. rajiv chowdhury and oscar franco conceived the presented idea. kim van daalen wrote the manuscript and designed the figure with support from rajiv chowdhury and oscar franco. all authors provided critical feedback and helped shape the presented analysis. rajiv chowdhury and kim r. van daalen are joint first author. oscar franco, md msc. dsc. phd., is a professor of epidemiology and public health and director of the institute of social and preventive medicine at the university of bern. rajiv chowdhury, md mphil phd., is a reader in global health at the university of cambridge. kim van daalen, bsc. mphil., is a phd student at the university of cambridge. world health organization. coronavirus disease (covid- ) prevalence of comorbidities and its effects in coronavirus disease patients: a systematic review and meta-analysis short term outcome and risk factors for adverse clinical outcomes in adults with severe acute respiratory syndrome (sars) the immunobiology of sars pathology and pathogenesis of severe acute respiratory syndrome the risk factors associated with mers-cov patient fatality: a global survey risk factors for severe outcomes following influenza a (h n ) infection: a global pooled analysis adherence to cardiovascular therapy: a meta-analysis of prevalence and clinical consequences antihypertensive drugs and risk of covid- 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consequences of covid- quarantine: special focus in older people. progress in cardiovascular diseases the compelling link between physical activity and the body's defense system be active during covid- coronavirus disease (covid- ): the need to maintain regular physical activity while taking precautions stress-induced immune dysfunction: implications for health the psychological impact of quarantine and how to reduce it: rapid review of the evidence covid- and your mental health post-traumatic stress disorder following disasters: a systematic review psychological stress and antibody response to influenza vaccination: a meta-analysis the mental health consequences of covid- and physical distancing world health organization. mental health and psychosocial considerations during the covid- outbreak the sleep-immune crosstalk in health and disease how (and why) the immune system makes us sleep is insomnia a risk factor for decreased influenza vaccine response? behav the role of sleep in emotional brain function sleep guidelines and help during the covid- pandemic alcohol potentiates hepatitis c virus replicon expression alcohol abuse, immunosuppression, and pulmonary infection impact of alcohol abuse on the adaptive immune system world health organization. covid- advice for public who why is changing health-related behaviour so difficult? public health the impact of the built environment on health behaviours and disease transmission in social systems inequalities in health: definitions, concepts, and theories key: cord- - nhbzybq authors: liu, jianghong; potter, teddie; zahner, susan title: policy brief on climate change and mental health/well-being date: - - journal: nurs outlook doi: . /j.outlook. . . sha: doc_id: cord_uid: nhbzybq climate change has a significant global impact on individuals’ mental health and well-being. however, global health systems are inadequately prepared to address this issue. studies indicate that climate events such as floods, droughts, tornados, earthquakes, and fires not only exacerbate chronic mental illness, but also impact well-being causing anxiety, stress, and in the worst case, suicide. the world health organization estimates that . million preventable deaths per year can be attributed to environmental factors, all of which are exacerbated by climate change, and an additional , deaths per year are projected between and . nurses must advocate for research, education, and policies that support disaster-resilient infrastructure and human services that allow communities across the globe to effectively mitigate the impact of climate change on human health. climate change is a fundamental threat to public and mental health and is already affecting individuals and communities across the globe. the world health organization estimates that . million preventable deaths per year can be attributed to environmental factors, which are exacerbated by climate change (world health organization, ). an additional , deaths per year are projected between and (world health organization, . furthermore, in the wake of the covid- pandemic, climate change, land use, and biodiversity loss are all connected and can contribute to the spread of future pandemics and diseases (vidal, ) , with % of the world's infectious diseases coming from the natural environment (brennan & micklas, ) . while the negative impact of climate change on physical health is acknowledged, recent evidence also points to profound adverse effects of climate change on well-being and on the exacerbation of existing acute and chronic mental health conditions. climate change related weather extremities and natural disasters impact mental health and well-being by disrupting health care resources and access, the economy, and social structures, and endangering the natural and social environments upon which people depend for their livelihoods, health, and well-being (o'neill et al., ; watts et al., ) . the nature of these changes disproportionately leaves impoverished and marginalized populations particularly vulnerable to the psychological stress and economic costs of climate-related disasters, causing already-disadvantaged groups to suffer disproportionately. while research continues to emerge, current evidence suggests that a wide range of serious physical and mental health consequences, including post-traumatic stress disorder (ptsd) and suicide and/or suicidal thoughts, result from exposure to climate-related disasters clayton, manning, krygsman, & speiser, ) . ptsd may stem from serious injury, death of family members, or forced displacement from home and is common as a result of natural disasters. the effects of climate change on ptsd has been primarily documented in the context of waterrelated disasters across countries and ethnicities. for example, after the torrential downpours and unstable levy infrastructure of hurricane katrina in , the psychological aftermath continued to persist in its survivors; within just a few months after katrina, the prevalence of ptsd in louisiana and mississippi rose from % a few months after katrina to % only a year later (kessler et al., ) . nearly % of adults (mclaughlin et al., ) and % of children (lai, kelley, harrison, thompson, & self-brown, ) had posttraumatic stress at some point afterwards. more recently, a study documented that at least twothirds of houston respondents indicated some level of post-traumatic stress from hurricane harvey in , which induced flooding of at least centimeters in more than , homes (grineski, flores, collins, & chakraborty, ) . the effect of flood-related disasters on ptsd has also been observed globally. one study investigating the effects of a severe flood in spain in found that the likelihood to suffer ptsd was . times higher in the population affected by the flood, with symptoms lasting for several months following the traumatic event (fontalba-navas et al., ) . another study conducted in india was consistent with reports in the united states and spain, with flood exposure substantially associated with ptsd and moderated by disrupted social support systems including family separation and broken peer connections (dar, iqbal, prakash, & paul, ) . given the enduring and far-reaching effects of ptsd symptoms following extreme rain and flooding, the development of population-scale methods and resources to combat ptsd is critical. similar to ptsd, rates of suicide and suicide ideation increase during times of climate-change related events, with heatwaves and droughts being especially concerning. alarmingly, a recent study has reported that rising temperatures may be responsible for nearly , suicides in india in the past years (carleton, ) . farmers, in particular, are a highly vulnerable group for risk of suicide during times of drought (ellis & albrecht, ) , as farmers and other residents of drought areas have significantly higher levels of anxiety, emotional distress, and depression (clayton et al., ; coêlho, adair, & mocellin, ) . in fact, the more severe the drought, the greater the suicide risk, and projections suggest that this trend will only be exacerbated by rising temperatures (ding, berry, & bennett, ) . although a myriad of complex factors contributes to the connection between climate change and suicide, these emerging data nevertheless underscore the urgency of developing effective mitigation and adaptation strategies. climate-change induced disasters, particularly heatwaves, may also lead to the exacerbation of existing acute and chronic mental health conditions. a canadian study observed that extreme environmental temperatures contributed to the psychotic exacerbation of schizophrenia, with persistently high temperatures associated with a significant increase in hospital emergency room visits for patients with mental disorders (wang, lavigne, ouellette-kuntz, & chen, ) . similar detrimental outcomes as a result of heatwaves were found in england (page, hajat, kovats, & howard, ) , where researchers found that patients with psychosis and dementia have a markedly increased mortality risk during heatwaves. in vietnam (trang, rockl€ ov, giang, kullgren, & nilsson, ), a similar occurrence was noted with a dose-response effect between rates of mental hospital admissions and the length of the heatwaves. however, while the former study found especially strong evidence for the worsening of psychiatric disorders in elderly populations, the latter reported more substantial effects in younger populations. for this specific age group, frequent assessment of children's well-being, especially in preparation for climate change related disasters, can allow for the identification of possible mental health issues, such as anxiety in face of disaster, and early preventative measures (dean et al., ) . although the mechanisms of action underlying the association between climate change and the exacerbation of mental health conditions is currently unclear, several mechanisms have been proposed, including pre-existing lowered resiliency to adapt to natural disasters (majeed & lee, ) and the magnification of other ongoing stressors (cunsolo willox et al., ) . further research in this field is necessary to elucidate the biological and psychological mechanisms of action, an undertaking that is crucial considering the quickly rising temperatures caused by climate change. future climate change predictions point towards more frequent and dangerous weather events, likely leading to an increase in individuals and communities experiencing higher rates of occurrence and severity of mental health problems. furthermore, a majority of existing studies are case-studies or focused on the immediate, short-term effects of a climate change outcome. as more individuals suffer from mental health effects of climate change, adequate resources, additional healthcare providers, further research, and appropriate community responses are needed to meet the increasing needs of the affected communities. the prevalence of these climate-change-related mental health outcomes, including ptsd, anxiety, depression, and suicide, as well as the contribution of climate change to the spread of pandemics and diseases like covid- , underscore the need for policy and preventive solutions, as well as the expansion of the conversation surrounding climate change, so that the impacts on mental health and wellbeing are discussed and considered especially in disaster preparedness planning. the academy's position on mental health the american academy of nursing (academy) identifies mental health as an urgent public health issue and supports policies targeted towards delivering highquality mental and behavioral health care. these policies include removing reimbursement and coverage barriers for mental health screening, intervention, and treatment (priester et al., ) and supporting resource allocation for the systematic integration of behavioral healthcare and primary care (davis et al., ) . the academy urges support for governmental programs addressing mental illness, as well as for the empowerment, education, and training of healthcare professionals for mental health treatment and care (hanrahan, stuart, delaney, & wilson, ; naegle et al., ) . the academy promotes the mental health of families, elders, and other vulnerable populations in order to foster resilience, health, and well-being (betz et al., ; tilden, ) . the academy places emphasis on both adaptation and prevention. adaptation is centered around developing reactive policies to the climate change issues that we know are already occurring. some examples of adaptive strategies include providing counseling (hayes, blashki, wiseman, burke, & reifels, ) , advocating for removal of barriers in access and cost to mental health care in insurance plans (rowan, mcalpine, & blewett, ) , and conducting more research on existing populations of individuals who have been affected by climate change (hayes et al., ) . these strategies would allow investigators to better understand the scope of the problem and develop more efficacious solutions to help those affected. prevention encompasses taking steps to increase knowledge of the effects of climate change on mental health in the public and to prepare for possible hazardous climate events in order to minimize their impact on health and well-being. thus, advancing mental health awareness and planning within the context of climate change is necessary and urgent (berry, waite, dear, capon, & murray, ) . possible strategies include encouraging school counselors and workers in homes for the elderly to begin early monitoring of those possibly at risk for mental health issues (hayes et al., ) , increasing the patient capacity of hospitals, and equipping hospital staff with the skills necessary for attending to patients specifically experiencing mental health issues in the context of climate change (laderman, dasgupta, henderson, & waghray, ) . in fact, the american academy of nursing is one of the endorsing organizations for the us call to action on climate, health, and equity: a policy action agenda (health voices for climate action, ). to reduce the psychiatric suffering exacerbated by climate change, the following interdisciplinary, multilevel recommendations addressing the impact of climate change on mental health and well-being should be implemented by policy makers, researchers, and health professionals in governmental, academic, clinical, and community settings. more specific strategies are detailed below. improve access to mental health services through increased and strengthened community-based mental health facilities in underserved areas with high risk of disasters related to climate change. for example, coastal communities prone to hurricanes and rural west coast communities prone to severe wildfires require more mental health providers in these areas (centers for disease control and prevention, ). promote community-level mental health initiatives that target vulnerable populations, including children and the elderly, as well as low-income populations that have limited resources to build resiliency during and after climate-change related disasters. educate patients and families about the health risks of climate change and how to prepare for and protect themselves. treat patients for specific psychiatric syndromes associated with climate related traumas. increase access to these services by continuing to increase the number of people with adequate health insurance through medicare and medicaid (national alliance on mental illness, ; rowan et al., ) . with a documented rise in hospital psychiatric admissions during times of climate change events, climate change impacts will likely cause increases in the demand for healthcare professionals and staff, as well as stretch the capacity of care delivery. in addition to a need for adequate resources, there is a need for an increase in the number of health-care practitioners, counseling services, clinics, and other health-related facilities in high impact areas for climate change outcomes. as the number of climate change related events will undoubtedly increase through the years, the supply of health providers and services must increase to meet the demand. this is particularly important given that the homes and families of providers may also have been adversely impacted by a disaster. further, an improvement in communication between the emergency department and communitybased outpatient mental health services would ensure adequate treatment and support for discharged patients and may lead to lower rates of hospital readmission (doupnik, esposito, & lavelle, ) . finally, considering that the majority of emergency departments in hospitals do not currently have the capacity or culture to support individuals with mental health issues, further discussion on developing new approaches to improve mental health care in the emergency department is necessary (laderman et al., ) . emergency department staff should also receive special training on addressing mental health issues specifically in those affected by natural disasters. increase the federal research funding provided by the national institute of mental health (nimh) and/or the substance abuse and mental health services administration (samhsa) targeting at prevention and intervention strategies to reduce the impacts of climate change on mental health (mental health america, ; national institute of mental health, ; substance abuse and mental health services administration, ). as a whole, the effects of climate change on mental and physical health are greatly under-researched, and further studies are warranted. for example, research could focus on intervention programs for patients suffering mental health issues following climate disasters or prevention programs for building resilience to the effects of climate change among people with mental health issues. future research should broaden the scope to examine how the type, intensity, duration, and frequency of climate change events add to the burden of mental illness globally. the disproportionate impact on disadvantaged and marginalized groups should be emphasized, especially in children, adolescents, and the elderly. furthermore, more thorough research should be conducted on long term implications on mental health across disciplines and populations. in addition, as the climate refugee situation expands and families are forced to leave low-lying coastal regions or fire prone areas, more research will be needed regarding the psychological impacts on the refugees themselves and the care providers required to serve the large number of new clients. improve community preparation and response to climate change in order to prevent and reduce impacts on mental health across the lifespan. for children and adolescents, schools should support nurses and counselors in recognizing and monitoring of mental health concerns among students. frequent monitoring of students' well-being and periodically following-up with students after a climate change crisis can help reduce the effect on mental health. similarly, nurses, counselors, and social workers in nursing and retirement homes should be more vigilant and trained in assessing, recognizing, and ameliorating the effect of climate change on mental health issues in the elderly (zalon, ). the substance abuse and mental health services administration (samhsa) provides communities and responders with behavioral health disaster response plans and training that help them prepare, respond, and recover from disasters. furthermore, community leaders should receive training in psychological first aid to understand the core principles of normalizing stress reactions to abnormal events, identifying and educating public to expected reactions, assisting community leaders in creating sense of safety, calmness, self and community effectiveness, supporting social connections and cohesiveness and sense of hopefulness (hayes et al., ) . advocate for increased budgets for the department of homeland security to allow for improved disaster preparedness preparation, response to mental health issues, infrastructure redesign, and federal response teams that can respond quickly when local health systems are overwhelmed in a disaster (department of homeland security, ). educate the public about the importance of anticipating and addressing mental health issues related to climate change through the national institute of mental health (nimh). currently the brochure titled "helping children and adolescents cope with disasters and other traumatic events: what parents, rescue workers, and the community can do" (national institute of mental health) does not alert health care workers or the general public to anticipate mental health issues related to climate change. nimh can partner with other organizations devoted to climate change and mental health, including climate psychiatry alliance and climate and mental health caucus of apa, to educate the healthcare providers and the general public. this policy brief reflects the current state of climate science and recommended policy changes. given the complexity of the earth's ecosystem, we must implement best practices while being aware that priorities and strategies themselves will need to adapt and change as new threats emerge. the case for systems thinking about climate change and mental health advancing the development of the guidelines for the nursing of children, adolescents, and families: revision: process, development, and dissemination things to know about climate change and coronavirus with who climate lead dr. campbell-lendrum higher temperatures increase suicide rates in the united states and mexico crop-damaging temperatures increase suicide rates in india mental health services for children policy brief retrieved / / from psychological research and global climate change mental health and our changing climate: impacts, implications, and guidance psychological responses to drought in northeastern brazil examining relationships between climate change and mental health in the circumpolar north ptsd and depression in adult survivors of flood fury in kashmir: the payoffs of social support a qualitative study of patient experiences of care in integrated behavioral health and primary care settings: more similar than different president's fiscal year budget fortifies dhs operations, supports frontline personnel the importance of humidity in the relationship between heat and population mental health: evidence from australia beyond mental health crisis stabilization in emergency departments and acute care hospitals climate change threats to family farmers' sense of place and mental wellbeing: a case study from the western australian wheatbelt. social science & medicine incidence and risk factors for post-traumatic stress disorder in a population affected by a severe flood hurricane harvey and greater houston households: comparing pre-event preparedness with post-event health effects, event exposures, and recovery mental health is an urgent public health concern climate change and mental health: risks, impacts and priority actions u.s. call to action on climate, health, and equity: a policy action agenda trends in mental illness and suicidality after hurricane katrina tackling the mental health crisis in emergency departments: look upstream for solutions posttraumatic stress, anxiety, and depression symptoms among children after hurricane katrina: a latent profile analysis the impact of climate change on youth depression and mental health recovery from ptsd following hurricane katrina the federal and state role in mental health access to treatment. national alliance on mental illness. national institute of mental health. helping children and adolescents cope with disasters and other traumatic events: what parents, rescue workers, and the community can do funding. national institute of mental health a new scenario framework for climate change research: the concept of shared socioeconomic pathways temperature-related deaths in people with psychosis, dementia and substance misuse treatment access barriers and disparities among individuals with co-occurring mental health and substance use disorders: an integrative literature review access and cost barriers to mental health care, by insurance status grants. substance abuse and mental health administration advance care planning as an urgent public health concern heatwaves and hospital admissions for mental disorders in northern vietnam destruction of habitat and loss of biodiversity are creating the perfect conditions for diseases like covid- to emerge acute impacts of extreme temperature exposure on emergency room admissions related to mental and behavior disorders in toronto the lancet countdown: tracking progress on health and climate change preparing older citizens for global climate change this policy brief represents the work of the environmental and public health expert panel, the health behavior expert panel, and the psychiatric, mental health, and substance abuse expert panel. key: cord- - gtnsyts authors: wolf, michael s.; serper, marina; opsasnick, lauren; o'conor, rachel m.; curtis, laura m.; benavente, julia yoshino; wismer, guisselle; batio, stephanie; eifler, morgan; zheng, pauline; russell, andrea; arvanitis, marina; ladner, daniela; kwasny, mary; persell, stephen d.; rowe, theresa; linder, jeffrey a.; bailey, stacy c. title: awareness, attitudes, and actions related to covid- among adults with chronic conditions at the onset of the u.s. outbreak: a cross-sectional survey date: - - journal: ann intern med doi: . /m - sha: doc_id: cord_uid: gtnsyts background: the evolving outbreak of coronavirus disease (covid- ) is requiring social distancing and other measures to protect public health. however, messaging has been inconsistent and unclear. objective: to determine covid- awareness, knowledge, attitudes, and related behaviors among u.s. adults who are more vulnerable to complications of infection because of age and comorbid conditions. design: cross-sectional survey linked to active clinical trials and cohort study. setting: academic internal medicine practices and federally qualified health centers. patients: adults aged to years living with or more chronic conditions. measurements: self-reported knowledge, attitudes, and behaviors related to covid- . results: a fourth ( . %) of participants were “very worried” about getting the coronavirus. nearly a third could not correctly identify symptoms ( . %) or ways to prevent infection ( . %). one in adults ( . %) believed that they were “not at all likely” to get the virus, and . % reported that covid- had little or no effect on their daily routine. one in respondents was very confident that the federal government could prevent a nationwide outbreak. in multivariable analyses, participants who were black, were living below the poverty level, and had low health literacy were more likely to be less worried about covid- , to not believe that they would become infected, and to feel less prepared for an outbreak. those with low health literacy had greater confidence in the federal government response. limitation: cross-sectional study of adults with underlying health conditions in city during the initial week of the covid- u.s. outbreak. conclusion: many adults with comorbid conditions lacked critical knowledge about covid- and, despite concern, were not changing routines or plans. noted disparities suggest that greater public health efforts may be needed to mobilize the most vulnerable communities. primary funding source: national institutes of health. t he severe acute respiratory syndrome coronavirus (sars-cov- ) and resultant coronavirus disease (covid- ) have evolved into a pandemic, requiring persons around the world to attend to rapidly changing messages about public health and take immediate actions to minimize their risk for infection and the spread of the virus ( ). this unprecedented global crisis has also been marked by miscommunication regarding the imminent threat of covid- , leading to public confusion and inaction ( ) . older adults and those with underlying health conditions are at greatest risk for severe infection and death due to covid- ( ) . the same factors that make individuals more vulnerable are also associated with reduced ability to access and understand health information, make well-informed decisions, and take optimal health-promoting actions-a skill set commonly called "health literacy" ( , ) . this is especially true when the health information itself is not timely, trusted, consistent, or actionable. health literacy has emerged over the past decades as one of the strongest psychosocial determinants of health, and it has also been shown to explain a range of health disparities by age, race/ ethnicity, and socioeconomic status ( ) . thus, in uncertain times like this, when the interpretation of critical and ever-changing public health messages is paramount, many vulnerable populations may be further marginalized by inadequate health communication, posing substantial risks to themselves and their communities. we did a time-sensitive study among higher-risk, older adults living with or more chronic conditions to determine their current awareness of covid- , their perception of the seriousness of its threat, their level of worry and concern related to contracting the virus, whether it is affecting their daily routine or existing plans, how prepared they feel to handle an outbreak, and their confidence in the federal government response. this took place from through march during the initial outbreak of the virus in the united states. we focused on the role of health literacy and other psychosocial health determinants in understanding risks for covid- and the initiation of preventive behaviors. health services, are sponsored by the national institutes of health, and are taking place among primary care sites ( academic internal medicine clinics and federally qualified health centers) across the greater chicago area ( table ) . health literacy and cognitive function among older adults (r ag ) is a cohort study examining cognitive and psychosocial factors associated with self-management and outcomes of chronic disease over time among predominately older adults. three randomized controlled trials-ehr-based universal medication schedule to improve adherence to complex regimens (r nr ), a universal medication schedule to promote adherence to complex drug regimens (r ag ), and transplant regimen adherence for kidney recipients by engaging information technologies: the take it trial (r dk )-evaluate health system strategies that leverage electronic health records and available consumer technologies to improve patient adherence and safe use of complex drug regimens. these studies were selected because they enroll mostly middle-aged or older adults (range, to years) with or more chronic conditions who therefore would be at greater risk for covid- . the studies use common assessments, allowing for uniform measurement of many patient characteristics. the northwestern university institutional review board approved study procedures, and all patients included in this telephone survey had provided prior consent to be contacted for future research opportunities. data were collected from through march . inclusion criteria varied across studies by age, presence of specific chronic conditions, having been prescribed complex regimens (≥ medications), and being an active patient at specified primary care sites; table provides study-specific eligibility criteria. methods of these studies have also been described in prior publi-cations ( ) ( ) ( ) . in brief, recruitment procedures included identifying potentially eligible participants via electronic health record queries; sending them a letter describing the study; then telephoning any patients who did not opt out of being contacted to introduce the study, screen for eligibility, and schedule an in-person baseline interview. common exclusion criteria for all studies include the presence of a severe and uncorrectable cognitive, visual, or hearing impairment that would preclude a participant's ability to complete interviews. for this survey, we targeted participants whose last interview was done between and the present. this time frame was selected to ensure that previously collected data from each parent study-which were merged with data from this survey-were most current; participants with the most recently collected prior data were prioritized for recruitment. trained research interviewers contacted participants outside their normally scheduled research interviews to invite them to answer a short set of questions pertaining to covid- by telephone. participant responses were recorded by interviewers using redcap web-based survey software. on average, surveys took less than minutes, and participants who completed the survey were told that they would be mailed a $ gift certificate for their time. in total, adults were enrolled in the parent studies and were eligible for the survey; were contacted during the week under investigation. of these, declined participation and could not be reached or asked to be contacted at a later date. in all, completed the study, for an overall cooperation rate of . %. across all studies, there was prior, uniform collection of patient demographics (age, sex, race, and ethnicity), socioeconomic status (household income, num- awareness, attitudes, and actions related to covid- awareness, attitudes, and actions related to covid- annals.org annals of internal medicine ber in household, educational attainment, employment status, and health insurance), and self-reported chronic conditions. all included the newest vital sign to assess health literacy ( ) . the consumer health activation index was used to determine patient activation across studies ( ) . in addition, a single item was used to capture self-reported overall health (excellent, very good, good, fair, or poor). for r ag , both englishand spanish-speaking patients participated; limited english proficiency (lep) was determined by patients self-reporting how well they spoke english. survey items were adapted from questionnaires used to study prior outbreaks ( ) . awareness of covid- was assessed using items that asked whether participants had heard of the novel coronavirus, if they had been told they had it or believed they did, or if someone they knew had been told they had it or believed they did ( table lists the items). perceived concern for covid- (more plainly called "coronavirus") was evaluated by first asking participants to rate, on a scale of to ( being no threat at all and being very serious), how serious a public health threat they believed the coronavirus is or might become. in addition, a single question asked participants to rate their level of worry about getting the coronavirus (very worried, somewhat worried, a little worried, or not worried at all). to provide context, this same question was asked with regard to influenza, and participants were also asked whether they had received an influenza vaccine in the past year. demonstrated knowledge of covid- was assessed through open-ended questions asking participants to name symptoms of the coronavirus and actions they could take to avoid becoming infected. five trained expert clinician raters (m.s., j.a.l., t.r., d.l., and m.a.) documented and independently coded verbatim responses, which were then thematically analyzed by members of the research team. in addition, participants were asked to estimate the percentage of persons who acquire the coronavirus who will die of it and the percentage who will have only mild symptoms. participants were asked whether they were currently making changes to their daily routines as a result of the coronavirus and whether they had changed any of their plans. verbatim responses were documented for participants stating that they had changed plans, and responses were also independently coded by trained raters and then thematically analyzed. respondents were asked about the likelihood of themselves or someone they know getting the coronavirus (very likely, somewhat likely, not that likely, or not at all likely). they also answered questions about their sources for information about the coronavirus, confidence that the federal government could prevent a national outbreak (very confident, somewhat confident, not very confident, or not confident at all), and perceived preparedness if a widespread outbreak were to occur (very prepared, somewhat prepared, a little prepared, or not prepared at all). descriptive statistics (means with sds and percentage frequencies) were calculated for all patient characteristics and survey responses. associations between patient characteristics and responses to covid- awareness, perceived concern, knowledge, and related awareness, attitudes, and actions related to covid- behavior items were then examined in bivariate analyses using tests, t tests, or analysis of variance, as appropriate. multivariable linear regression models were used to estimate least-squares means (with % cis) for the continuous outcome of perceived concern. for dichotomous outcomes, a multivariable poisson distribution was used rather than odds ratios for the relative risk estimates ( ) . all models included health literacy as a primary covariate of interest, additional variables affecting knowledge and behavior (age, gen-der, race, and income), day the survey was done, and parent study. statistical analyses were performed using stata/se, version (statacorp). the study was supported by national institutes of health projects. the funding sources had no role in the design, conduct, or analysis of the study or the decision to submit the manuscript for publication. table summarizes respondent characteristics. participants were older overall, and . % were female. the sample was racially and ethnically diverse, and many participants were socioeconomically disadvantaged: nearly a third ( . %) were living below the poverty level. about half of adults had low or marginal health literacy, all had at least chronic condition, and two thirds ( . %) were living with or more chronic conditions. all participants had heard of the coronavirus (covid- ) , and most considered the potential threat to be high ( table ) . one in ( . %) said that they were "very worried" about getting the coronavirus, and . % were not worried at all ( table ); in contrast, . % said that they were "very worried" about getting influenza, and . % were not worried at all. half ( . %) rated their worry about covid- and influenza the same, whereas . % were more worried about getting covid- . very few participants ( . %) believed that they would definitely or probably get the coronavirus. the threat of a covid- outbreak was rated to be more serious by adults aged years or older and by women before adjustment; those with or more chronic conditions rated the threat as less serious than those with fewer conditions ( table ) . black participants were more likely than white participants to report that they were "not worried at all" about getting the coronavirus; this was also true for those reporting poorer health. women, black and hispanic persons, those with lep, those living below the poverty level, those with lower health literacy, and unmarried persons were significantly more likely to respond that it was "not at all likely" that they would get covid- . in multivariable analyses, women remained more likely than men to rate the seriousness of the covid- threat as high, whereas adults living below the poverty level rated it as less serious than those with higher incomes ( table ). respondents' ratings of the seriousness of covid- also significantly increased by day of awareness, attitudes, and actions related to covid- interview, with higher ratings at the end of the survey period than at the beginning. blacks were more likely than whites to be only "a little worried" or "not worried at all" about getting the coronavirus, and black race, living below the poverty level, and low health literacy all remained independently associated with participants' belief that it was "not at all likely" that they would get sick with covid- . on average, respondents estimated that more than half ( . %) of infected persons will have only mild symptoms and . % will die of covid- ( table ) . most participants correctly identified symptoms ( . %) and ways to prevent infection ( . %). women estimated fewer mild cases and more deaths than men (table ). this was also true for blacks relative to whites, for those living below the poverty level, and for those with lower health literacy. participants who were older, black, unmarried, unemployed, or retired; had poorer health; or had lower health literacy showed poorer knowledge of covid- ( table ). those who identified as being hispanic and having lep demonstrated greater covid- knowledge. after multivariable adjustment, patient characteristics were no longer associated with knowledge of covid- symptoms or means of prevention ( table ) . more than half of patients ( . %) reported that the coronavirus had caused them to change their daily routine "a lot," whereas . % said that they had changed existing plans as a result ( table ). men; black persons; those with lep, lower health literacy, or or more chronic conditions; those living below the poverty level; and persons who were unmarried, unemployed, or retired were less likely to makes changes because of the coronavirus ( table ) . after multivariable adjustment, these patient factors were no longer associated with changes to either daily routine or existing plans. in contrast, respondents who were interviewed later in the -week survey period were more likely to report that their daily routine had changed "a lot" ( table ) . one in respondents ( . %) reported that they were "very prepared" for a widespread outbreak. nearly a third ( . %) had no confidence that the federal government could prevent a nationwide outbreak; . % were very confident ( table ) . black and hispanic adults; those with lep, lower health literacy, lower health activation, or poorer health; those living below the poverty level; and those who were unmarried, unemployed, or retired were more likely to con- awareness, attitudes, and actions related to covid- annals.org annals of internal medicine sider themselves either "a little prepared" or "not prepared at all" ( table ). in multivariable analyses, black race and low health literacy were both independently associated with a greater likelihood of feeling only "a little prepared" or "not prepared at all" ( table ) . hispanic persons, those with lep, those living below the poverty level, and those with lower health literacy were also more likely to be "somewhat" or "very" confident in the federal government. in multivariable analyses, only low health literacy remained associated with feeling "somewhat" or "very" confident in the federal government's ability to prevent a nationwide outbreak ( table ). in a survey of more than sociodemographically diverse adults with chronic health conditions living in chicago, we found that most respondents perceived the threat of a covid- outbreak to be serious, although the level of worry varied; half equated the threat with that of influenza, and only a few reported being more worried about getting influenza than covid- . nearly one third could not identify symptoms or proper measures to prevent infection. most respondents reported that the virus was affecting their daily routine and leading to changes in already made plans, yet in adults believed that it had little or no effect on their lives or plans. nearly in participants believed that they were only a little or not at all prepared for a covid- outbreak, whereas just in believed that they were very prepared. only in respondents was very confident that the federal government could prevent a nationwide outbreak of this virus. at the time of writing, illinois ranks seventh in the united states with more than covid- cases, and state residents have died. when our c survey started on march , there were only cases and no deaths; by the end of the survey on march, there were cases and deaths. across the united states and worldwide, the outbreak was increasing at a rate of % to % more new cases daily during the week of the interviews. at the same time, several measures were announced in succession: schools began closing across illinois, employers were sending staff home to work remotely, various public restrictions were implemented (bar and restaurant closures and limitations on gatherings), and ultimately a "shelter at home" order was announced. thus, our findings provide a rare snapshot of how a cohort of mostly middle-aged and older adults with underlying health conditions adapted to this unprecedented time and took action, or not. our study identified concerning demographic and socioeconomic differences in how individuals perceived the threat of covid- and, perhaps, their own ability to take actions to prevent illness. specifically, those who were black, were living below the poverty level, and had low health literacy were less likely to believe that they might become infected, and black respondents were less worried about the pandemic. black adults also felt less prepared for an outbreak than white adults, and individuals with low health literacy reported not only being less prepared but also having more confidence in the federal government response. although the reasons for these findings are not clear, similar results were reported during the h n influenza pandemic in ( ) . trust in public health officials, information-seeking behaviors, sources of information, frequency of media exposure, knowledge, and worry related to the outbreak were all highlighted determinants of documented disparities in uptake of recommended behaviors. in our study, disparities by race, socioeconomic status, and health literacy were not reflected in ratings of the seriousness of the covid- threat, demonstrated knowledge of its symptom presentation or general means to prevent it, or reported changes to daily routines and plans. prior research has documented racial differences pertaining to trust in the health care system ( ) ( ) ( ) . for those who are living below the poverty level or have low health literacy, perceptions of personal risk and the ability to prevent infection may be limited. this may be due to feeling less able to change one's social circumstance, or lack of public health communications that are explicit and actionable and provide clear, efficacious messaging pertaining to recommended protective behaviors ( , ) . a previous report found socioeconomic and literacy disparities in mortality associated with the influenza pandemic; likewise, our findings should raise caution ( ) . although the current public health infrastructure is different, existing efforts may not be adequately reaching these vulnerable populations. our study, working to quickly capture the opportunity to understand how the most vulnerable are processing current events, clearly has limitations. first, this survey was done among a selected group of patients who were all active participants in cohort studies or clinical trials sponsored by the national institutes of health in large u.s. city. thus, these findings may have limited generalizability, especially for younger adults and those without underlying health conditions. however, our study samples purposefully include men and women who are socioeconomically, racially, and ethnically diverse and are at greatest risk for covid- because of age and underlying conditions. second, to rapidly implement our investigation and quickly recruit as large a sample as possible during the first of multiple waves of interviews, we were limited in the depth of our survey and number of items to use. prior research on virus outbreaks guided our selection and creation of survey items ( ), but we lacked the time or opportunity to validate all questions, particularly in the midst of a public health crisis. however, items followed best practices for the design of assessments for use among persons with lower literacy ( ) . third, our outcomes capture only initial awareness of covid- , degree of worry, fundamental knowledge, attitudes, and a limited set of behaviors. understanding of the virus has since evolved, and we could not expand on those developments. items included in planned follow-up waves of original research awareness, attitudes, and actions related to covid- the survey will adapt accordingly and expand data capture on behaviors, among other just-in-time topics. finally, as a time-sensitive study, what we have learned in this initial, critical week, when covid- most fully took hold in the united states, is that public health messaging has dramatically changed: new policies, state restrictions, and information are being shared not just daily but hourly. it is likely that all of what we report in this -week glimpse has considerably altered. regardless, our findings depict the initial lack of clarity in understanding, perceived susceptibility, and personal efficacy regarding the pandemic among those at greatest risk. that is why we intend to continue to follow this cohort as part of an ongoing c initiative. this first wave of the c study revealed profound gaps in awareness, knowledge, concern, and preemptive public health action. the potential for the covid- pandemic to exacerbate health disparitiespotentially through mechanisms related to inadequate or conflicting public health messaging among those who are socioeconomically disadvantaged, belong to racial minority groups, or have more limited health literacy-may be exceptionally high. actions are needed now to ensure that as the pandemic unfolds, all citizens are adequately made aware of the gravity of the threat; with great clarity and attention to health literacy best practices, we need to explain specific steps that must be taken to avoid harm. grant support: by grants r ag , r ag , r dk , and r nr from the national institutes of health (nih). disclosures: dr. wolf reports grants from the nih during the conduct of the study; grants from merck, the gordon and betty moore foundation, the nih, and eli lilly outside the submitted work; and personal fees from sanofi, pfizer, and luto outside the submitted work. dr. serper reports personal fees from biovie outside the submitted work. ms. batio reports grants from the nih during the conduct of the study. dr. ladner reports grants from the national institute of diabetes and digestive and kidney diseases during the conduct of the study. dr. persell reports grants from omron healthcare and pfizer outside the submitted work. dr. bailey reports grants from the nih during the conduct of the study; grants from merck, the nih, and eli lilly outside the submitted work; grants and personal fees from the gordon and betty moore foundation outside the submitted work; and personal fees from sanofi, pfizer, and luto outside the submitted work. authors not named here have disclosed no conflicts of interest. disclosures can also be viewed at www.acponline.org/authors /icmje/conflictofinterestforms.do?msnum=m - . study protocol and statistical code: available from dr. wolf (e-mail, mswolf@northwestern.edu). data set: available to those who meet prespecified criteria; access allowed to deidentified data only. available from dr. wolf (e-mail, mswolf@northwestern.edu). corresponding author: michael s. wolf, phd, mph, ma, feinberg school of medicine, northwestern university, north lake shore drive, th floor, chicago, il ; e-mail, mswolf@northwestern.edu. current author addresses and author contributions are available at annals.org. covid- coronavirus outbreak. accessed at www .worldometers.info/coronavirus on coronavirus disease : the harms of exaggerated information and non-evidence-based measures prevalence of comorbidities in the novel wuhan coronavirus (covid- ) infection: a systematic review and meta-analysis health literacy and functional health status among older adults the prevalence of limited health literacy the relationship between health literacy and health disparities: a systematic review rationale and design of the regimen education and messaging in diabetes (remind) trial literacy, cognitive function, and health: results of the litcog study development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults quick assessment of literacy in primary care: the newest vital sign development and validation of the consumer health activation index perceptions and plans for prevention of ebola: results from a national survey a modified poisson regression approach to prospective studies with binary data what have we learned about communication inequalities during the h n pandemic: a systematic review of the literature the role of risk perception in flu vaccine behavior among african-american and white adults in the united states determinants of influenza vaccination among high-risk black and white adults. vaccine association of patient perceptions of cardiovascular risk and beliefs on statin drugs with racial differences in statin use: insights from the patient and provider assessment of lipid management registry how does education lead to healthier behaviours? testing the mediational roles of perceived control, health literacy and social support disparities in influenza mortality and transmission related to sociodemographic factors within chicago in the pandemic of development of the patient education materials assessment tool (pemat): a new measure of understandability and actionability for print and audiovisual patient information original research awareness, attitudes, and actions related to covid- current author addresses: drs. wolf, o'conor, arvanitis, persell feinberg school of medicine, northwestern university, north lake shore drive, th floor dr. ladner: feinberg school of medicine, northwestern university, north saint clair street critical revision of the article for important intellectual content key: cord- -l d rgt authors: turcotte-tremblay, anne-marie; fregonese, federica; kadio, kadidiatou; alam, nazmul; merry, lisa title: global health is more than just ‘public health somewhere else’ date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: l d rgt nan ► global health can be anywhere as it often focuses on large-scale health inequities that are rooted in transnational determinants. ► some global health initiatives and actors aim to find solutions to domestic problems. ► king and koski's definition of global health may exacerbate inequities by reserving the right to call oneself a global health researcher to those who are privileged and have access to funding that enables them to travel to other settings. ► an inadequate definition of global health based on a 'here' vs 'somewhere else' dichotomy could result in less funding for a field already characterised by limited resources. ► the decolonisation of global health requires promoting and valuing reflexivity, critical approaches, equitable partnerships and accountability. king and koski recently published a bold commentary in bmj global health that defines global health as 'public health somewhere else'. it raises important concerns about the justification, scope, efficiency and accountability of the field. we appreciate that the commentary compels us to reflect on the definition of global health, its application and how the field could be improved. we also agree that many of the issues highlighted by the authors (ie, political priorities driven by the north, expertise from the north being overvalued) do exist in some global health interventions. many of us have heard of or witnessed disastrous situations caused by seemingly wellintentioned people. however, the problems described are not unavoidable or intrinsic characteristics of global health. moreover, we believe the proposed definition of global health is not adequate to conceptualise the field. rather than prompting improvements, it could result in mistrust towards global health and be a step backwards for the field. in the following, we contend that global health is more than just 'public health somewhere else' and argue that an inadequate definition entails risks for the field. . the populations of interest in these instances can be anywhere (low, middle and high-income countries) and include anyone affected and facing health inequities due to these transnational or global issues. the solutions can also be global or transnational in nature. the coronavirus pandemic is an example of a global health problem that is affecting people everywhere, especially vulnerable groups. due to the ever-increasing movement of people across borders, viruses like covid- can spread easily and quickly around the world and affect anyone, irrespective of whether they are in the global north or south. a global health response involving most countries that includes data sharing and coordinated efforts to stop the spread, find treatments and a cure as well as protect vulnerable groups (eg, elderly, migrants, prisoners, homeless) is therefore necessary. second, we disagree with king and koski's statement that 'a person engages in global health bmj global health when they practice public health somewhere-a community, a political entity, a geographical space-that they do not call home'. to us, this is an oversimplified statement. several of our colleagues, and we as well, have received funding to engage in global health in places we call home. for example, kk has conducted research on social protection policies in burkina faso, her home country. similarly, na has conducted research on the health of migrant workers in bangladesh, where he lives. we should be applauding and valuing global health initiatives that are led by local researchers/practitioners rather than excluding them from the definition. moreover, king and koski's definition is not adequate because some global health initiatives are aimed at finding solutions to domestic problems, whether it be in a high, middle or low-income country. for example, grand challenge canada funded the adaptation and transfer of innovations from low and middle-income countries to make a difference in canada. while the innovations come from abroad, the primary focus or end goal of such initiatives is quite local. this also highlights the fact that solutions for health problems in the north and south sometimes stem from expertise in the south. according to syed et al, global health partners are increasingly seeking a mutuality of benefits across countries. third, there are many public health researchers and practitioners working 'somewhere else', in a place that 'they do not call home', whose work does not qualify as global health. they do not view themselves as part of the global health community, nor do they actively participate in global health activities. their practice and research would also not be eligible for global health funding. for example, a canadian medical student's clinical placement in a public health unit in belgium is not automatically considered training in global health simply because it is done in another country. therefore, referring to global health merely as public health 'somewhere else' is not useful. fourth, we consider that king and koski's commentary and definition discredit the field of global health and fail to recognise its added value. while it is crucial to reflect on limitations, it is also important to highlight the field's strengths, best practices and success stories. there are examples of global health research and interventions where countries and communities have worked collaboratively and shared expertise, cultural knowledge and other resources to develop appropriate and effective solutions. [ ] [ ] [ ] moreover, while global health is considered one of the multiple branches of public health, the literature does suggest there are differences among them. for example, global health tends to have a broader focus (ie, health for all worldwide), a greater emphasis on health inequities, more interdisciplinarity and more 'bridging' between cultures and communities. practitioners and researchers working in global health also face unique ethical challenges (eg, power differentials between parties) and require that some key competencies be further developed (eg, cultural safety and inclusion, partnership development). recognising global health as a field in its own right is crucial to ensure there are dedicated resources for training and forums where the global health community can exchange and share knowledge, so that best practices can be further promoted, especially among students and emerging researchers and practitioners. it is also vital that global health be recognised as a distinct field so that resources will be made available to support global health initiatives that can promote the human right to health and help meet the global pledge to 'leave no one behind'. the proposed definition by king and koski entails several risks. first, accepting the definition proposed would mean that global health initiatives led by local actors or community leaders in low or middle-income countries, or by indigenous or migrant communities in high-income countries, would not be acknowledged and considered global health. this in turn could lead to devaluing their contribution as global health actors and limiting their access to resources to support their work, despite there being significant needs. therefore, rather than moving us 'towards an eventual decolonisation of global health', the definition by king and koski might actually reinforce the problems they highlight in their article, including inefficiency, lack of accountability and uncritical faith in western expertise, because only 'foreigners' would be acknowledged as doing global health. second, the definition may exacerbate inequities by reserving the right to call oneself a global health researcher, and the related expertise, exclusively to those who are privileged and have access to funding that allows them to travel and practise or conduct research in other settings that they do not call home. third, the definition would limit the scope of problems and solutions considered, possibly neglecting global and transnational issues. fourth, if global health is conceptualised as public health elsewhere, what interest would countries and communities have in investing in global health? this could result in less funding for a field that already faces the challenge of limited resources. lastly, the definition and commentary imply that working somewhere else is somewhat problematic and negative. we are concerned that this view is divisive and dangerous. it could contribute to ethnocentrism and ultimately limit the sharing of knowledge and expertise across groups. a 'here' versus 'somewhere else' dichotomy seems counterproductive. we live in a globalised world, and more than ever we are interconnected and interdependent. everyone in high, middle and low-income settings has a vested interest in attaining health for all and reducing health inequities. concerns over pandemics (covid- !), global warming, environmental degradation bmj global health and potential misuse of technological advances (the easy spread of fake news!) affect us all. protecting the most vulnerable is beneficial for everyone-for our economic, social, mental and physical well-being. as a burkinabé saying goes, 'we are together'. currently, global health may not be perfectly practised, but we need inclusive definitions, frameworks and training programmes that set the standards towards which we should all strive. we can have transparent discussions and be critical of global health academic programmes, research and practices, while sharing an adequate definition. we should condemn bad practices, rather than condemn the whole field. true partnerships across disciplines and geographic boundaries, which have resulted in meaningful projects, exist and can be further promoted. we need to promote the strengths and best practices of the field and value success stories while learning from failures. ultimately, the decolonisation of global health requires training programmes that teach reflexivity, critical approaches, equitable partnerships and accountability. such training programmes, and all global health initiatives more broadly, should include participatory approaches and ensure there are benefits for all stakeholders involved. resources should also be expended equitably. these are all good practices that are attainable. this is the morally 'right way' to do global health, and also a more effective way to achieve 'health for all'. contributors amtt conceived the main idea presented. all authors contributed to the conception and writing of the commentary. funding we thank the quebec population health research network for its contribution to the financing of this initiative. moreover, amtt received a training bursary from the canadian institutes of health research (cihr). lm was supported by a research scholar junior award from the fonds de recherche du québec-santé (frqs). competing interests none declared. patient consent for publication not required. provenance and peer review not commissioned; internally peer reviewed. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. anne-marie turcotte-tremblay http:// orcid. org/ - - - defining global health as public health somewhere else towards a common definition of global health rethinking the 'global' in global health: a dialectic approach developed-developing country partnerships: benefits to developed countries? reverse innovation" could save lives. why aren't we embracing it? in: the new yorker the global health research capacity strengthening (ghr-caps) program: trainees' experiences and perspectives the what works working grouplevine r. millions saved. proven successes in global health emergence and robustness of a community discussion network on mercury contamination and health in the brazilian amazon ngo-researcher partnerships in global health research: benefits, challenges, and approaches that promote success lessons from developing, implementing and sustaining a participatory partnership for children's surgical care in tanzania public health and global health definitions beyond procedural ethics: foregrounding questions of justice in global health research ethics training for students l'évaluation qualitative, informatisée, participative et inter-organisationnelle (equipo) key: cord- - xjkv m authors: martin, anastasia; blom, iris martine; whyatt, gemma; shaunak, raghav; viva, maria inês francisco; banerjee, lopamudra title: a rapid systematic review exploring the involvement of medical students in pandemics and other global health emergencies date: - - journal: disaster medicine and public health preparedness doi: . /dmp. . sha: doc_id: cord_uid: xjkv m objectives: the role of medical students in the current coronavirus disease (covid- ) pandemic is rapidly evolving. the aim of this review is to explore the involvement of medical students in past global health emergencies, to help inform current and future scenarios. methods: a rapid systematic review was undertaken, including articles from online databases discussing the roles, willingness and appropriateness of medical student involvement in global health emergencies. data were extracted, appraised and written up as a narrative synthesis. this study was registered with prospero (crd ). results: twenty-eight articles were included. medical students played a wide variety of clinical and nonclinical roles including education and logistics, although medical assistance was the most commonly reported role. challenges included a lack of preparedness and negative mental health impacts. a total of . % of included articles about willingness found medical students were more willing to be involved than not. conclusions: this review shows medical students are capable and willing to be involved in global health emergencies. however, there should be clear protocols for the roles that they play, taking into account the appropriateness. as a rapid review, there were study limitations and more research is required regarding the impact of these roles on medical students and the system. m edical students represent a largely untapped reservoir of potential in global health issues. this group can provide a youth perspective to global health issues, contribute to research in a manner in which busy seniors cannot, and be an addition to the global health workforce in times of need. , this last point is the focus of our research. at the time of writing (april ), the world was experiencing coronavirus disease (covid- ); a pandemic with unprecedented social and financial impacts that was placing pressure on healthcare systems around the world. one solution to alleviating this pressure was by asking medical students to help. [ ] [ ] [ ] many medical schools have been suspended or moved to online platforms, leaving students with extra time on their hands; time that can potentially be spent helping. , medical students worldwide have already started moving to the frontline. in the united kingdom and brazil, for example, final year medical students have been fast-tracked to join the workforce early. , guidance toward medical students helping on the frontline has been published by several organizing bodies, but due to the dynamic situation, this guidance continues to change. , therefore, it is important to ascertain what exactly would be the best way for medical students to help. the primary role of the medical student is to learn to be a doctor, and deviations from this may have consequences both for medical students and the healthcare system around them. however, having students in the healthcare environment during a pandemic can be an increased burden to clinicians who need to invest time to teach them. consequently, students' education and patients' care may be compromised. currently, there are multiple articles describing the role of medical students in past similar scenarios, their willingness to assist, as well as opinions on what roles medical students should play during covid- . , however, to our knowledge, a systematic review that combines and assesses this information does not currently exist. filling this gap in the evidence base will help better inform what role medical students can play in future global health emergencies, including covid- . the aim of this review was to systematically assess how medical students can be involved in pandemics and global health emergencies. by outlining the roles medical students have already undertaken or potentially can undertake, the appropriateness of these roles, as well as how willing medical students are to be involved, this review can be used to guide decision-makers to design safe and effective roles for medical students in current and future global health emergencies. a rapid systematic review was used to collate, critically appraise, and synthesize the information, because it answered our question in a timely manner so our research could potentially inform the covid- pandemic. prisma guidelines were followed throughout the process. the review protocol submitted on march , , accepted april , and can be found in the prospero database [number: crd ]. four independent reviewers (a.m., r.s., i.b., i.v.) conducted a systematic search on march , . pubmed, medline, embase, and the global health database were searched for eligible studies with no date restrictions. studies were available from to march . the full search strategy can be found in appendix . bibliographies from eligible articles were screened (ie, snowballing) and the "journal of disaster medicine and public health preparedness" was hand searched through all volumes for further articles by reviewer l.b. papers were initially screened by title and abstract and shortlisted articles were screened for full-text analysis against eligibility criteria by all reviewers and any disputes were discussed. data from eligible articles were inputted into a tailored data collection form which was trialed by reviewers before use. all steps were recorded using the prisma diagram. all studies that discussed roles medical students have played or can play, their willingness to do so, or whether they should do so in an acute global health emergency, including hypothetical studies, were included. "global health emergency" was defined as any event that significantly and acutely affected the capacity or functioning of a health system in or more countries, including but not limited to: infectious disease outbreaks, natural or man-made disasters, and armed conflict. only english language articles were included. the population of interest was medical students, defined as anyone from any country enrolled in a university course (undergraduate or postgraduate) training to be a doctor who has not yet finished their medical education. articles that involved other participants (eg, nursing students) but also mentioned medical students, were included. qualitative research, quantitative research, and mixed methods studies, including systematic, scoping and literature reviews, published editorials, commentaries, and conference abstracts were included. we included gray literature to add a wider perspective. gray literature included unpublished or nonpeer reviewed papers, reports, theses, and technical documentation. studies involving nonacute events and diseases that were deemed nongeneralizable to the covid- outbreak, eg, the opioid epidemic and obesity crisis, were excluded. furthermore, studies that did not discuss medical students, eg, studies that exclusively discussed other populations (eg, veterinary, dental, or nursing students) were excluded because they did not include our population of interest. non-english language papers were also excluded due to time constraints of translating these papers. our primary outcome was to collate descriptions of the roles medical students can play in a pandemic. these were predefined in the data extraction proforma as: clinical assistance; testing; helplines; triage; raising awareness; or "other," if a different role was described, which the reviewer then specified. our secondary outcomes included the level of willingness of medical students to help, factors affecting willingness, and appropriateness of the role. data were extracted using the predefined standardized form and included: article, author, year, journal, country, article type, article design, aim, area studied (role/willingness/appropriateness/preparedness), article population, setting/context, the number of participants, methodology, outcomes, key findings, relation to past global health emergency (if applicable), comments on the role; comments on willingness, comments on appropriateness, and critical appraisal. articles were critically appraised globally and briefly judged for risk of bias; however, the full use of quality assessment tools was not feasible due to time constraints. all included papers were critically appraised using the reviewers' judgment, expertise, and by means of discussion among the researchers. the design, outcome measure, and whether the study was peerreviewed or a gray literature study played a role in guiding whether articles are of high or low quality and are reported on in the discussion section. data were analyzed thematically and written up as a narrative synthesis. our search identified articles as well as from extra sources. a total of articles were screened for title and abstract, and of those were excluded. sixty-six articles were screened for the full manuscript, and of those met the inclusion criteria ( figure ). most of the included articles had good quality of evidence but unpublished gray literature (eg, expert opinion pieces) had poorer evidence quality. table shows the baseline characteristics of all included articles. seventeen articles discussed roles, discussed willingness, and directly discussed appropriateness (chen e, goodman kw, fiore rn. involving medical students in disaster response: ethics, education and opportunity [unpublished pdf]. ; - ). as well as articles purely discussing medical students, articles also examined nursing, pharmacy, and dental students. the views of medical students across multiple years were examined with an even spread. the context of the global health emergencies is detailed in table , with articles reporting on past situations that happened and articles discussing hypothetical scenarios (table ). seventeen of the included articles discussed the roles of medical students during global health emergencies ( table ). the most commonly reported role was providing clinical assistance (n = ). in of these articles, medical students acted as junior doctors. , in , during the outbreak of the spanish flu, medical students acted as nurses and interns because the usual medical workforce were away assisting the war troops. during the kashmir earthquake in pakistan, medical students were sent to less accessible places compared with senior doctors due to their young age. in , after an earthquake, a tsunami hit chile and medical students provided medical care in remote areas. recently, it has also been hypothesized that medical students can provide clinical care by distributing medication to hospital staff and providing manual ventilation. , the role of medical students as educators through raising awareness was also highlighted (n = ). in , during the hiv epidemic, medical students developed a peer-to-peer teaching system to raise awareness and contribute to better patient care. during the severe acute respiratory syndrome (sars) and ebola outbreaks, students held (online) campaigns to promote healthier behavior. , other reported roles entailed nonclinical assistance. in , in the immediate liberation of belsen concentration camp, medical students set up an acute care hospital for emergency treatment of the inmates waiting to be transferred and a pharmaceutical dispensary. during the wtc terrorist attack, medical students participated as "runners" to carry information between triage stations, prepared food for rescue workers, worked in emergency hotlines to provide information to families of victims, fundraised, donated blood, and assisted in psychiatric disaster services (chen e, goodman kw, fiore rn. involving medical students in disaster response: ethics, education and opportunity [unpublished pdf]. ; - ). medical students who were further in their medical education were more likely to provide medical assistance (n = ). , , , , , furthermore, the challenges faced by medical students in their roles during the global health emergency was discussed (n = ). these challenges included: a lack of supervision, treating children, and prioritizing medical need. , the impact on the mental health of medical students was also highlighted, both during and after the emergency event (n = ). , , for example, during the provision of clinical care during the influenza epidemic, medical students experienced psychological distress during their fieldwork, such as fear, anxiety, depressive symptoms, despair, and panic. an article on the wtc terrorist attack suggested that the type of role played appeared to correlate with how much the students were affected. it was found that students working in fundraisers and hotlines had significantly higher symptoms. medical students who assisted in medical care at hospitals had the fewest symptoms and a greater sense of empowerment. the same article also concluded that involvement in the disaster was associated with a reinforced desire to become a physician. twelve of the included articles evaluated the willingness of medical students to help in disaster situations (table ) . most (n = ) reported quantitative data on the level of willingness of medical students to help in a disaster as shown in table . the percentage of medical students willing to help ranged between % and . %, with of the articles reporting a willingness percentage greater than or equal to %. one article reported the willingness of medical students to be involved on a different scale but equated it as "moderate willingness." one article did not provide quantitative data but reported that "the majority of students responding to the survey were willing to respond to disaster events." seven of the included articles provided reasons to explain the medical students' level of willingness. obligation or social responsibility was stated most commonly, along with altruism, as a reason why medical students were willing to be involved. concerns for personal health and safety, as well as concerns for family health and safety, were the most commonly stated reasons for students being unwilling to help (table ). some (n = ) also discussed factors that affected the willingness, which are described in table . when comparing willingness levels with medical students' confidence and knowledge in the final y of medical school, willingness was seen to be proportionally higher than knowledge. , , [ ] [ ] [ ] one article reported over % of students willing to help, but only . % of students believed they have the skills to help. thirteen articles discussed appropriateness of the roles. this included looking at medical students' confidence and preparedness for specific roles. five studies measured students' skill levels; confidence to deal with emergency outbreaks ranged between . and . % (table ). , , [ ] [ ] [ ] three articles found that students' willingness was high, but when compared with their self-perceived knowledge, they did not feel prepared. [ ] [ ] [ ] the perspective study by starr describes "for me and my classmates, knowledge of the disease we were to face so soon was limited to the contents of that lecture." the need for disaster management training was also highlighted (n = ), due to the lack of preparation of students. , only articles reported training their students before carrying out their role, and reyes described volunteers as being "quickly trained." . . there are ethical issues of involving medical students in global health emergencies, including students' safety, medico-legal issues, and health insurance of students. , , eastwood et al. specifically highlighted the importance of students to be well informed and be able to make the decision of being involved themselves. the review outlines the past involvement of medical students in global health emergencies. this can help to guide decisionmakers in choosing appropriate roles that medical students are willing to do and are prepared to carry out in a global health emergency. historically, medical students have been involved in the response to global health emergencies and pandemics in a variety of ways. , , , , , our results identified a range of roles that students have played in the past, thus highlighting the potential roles medical students are able to play in the current covid- pandemic or future global health emergencies. unlike members of the general public, medical students have attained several relevant clinical skills during their years of training, which can be useful in a situation where the healthcare system is under pressure. for example, in study, students assisted the resuscitation team, a skill students learn during medical school. the current data suggest that the most common roles played were, in fact, clinical roles. however, nonclinical roles, such as runners to carry information, assisting in hotlines, and psychiatric services were also described (chen e, goodman kw, fiore rn. involving medical students in disaster response: ethics, education and opportunity [unpublished pdf]. ; - ). a role that should not be neglected, however, is the normal role of a medical student-to learn. it is important to consider whether these alternative roles are appropriate in a specific situation. of interest, study concluded that being involved in such situations helps strengthen students' desires to become physicians, suggesting that involvement does not only help to serve healthcare systems but the students themselves. other studies have also found clinical volunteering to be perceived positively by medical students, helping them develop clinical skills and collaborate with other healthcare professionals. the range of roles described in the included articles highlights the versatility of medical student involvement. for example, articles also described that medical students further in their medical education were more likely to provide medical assistance. , , , , , one study found younger students were involved in more educational roles as first year students helped by raising awareness for hiv. this demonstrates that involvement in the response to global health emergencies is not limited to advanced medical students and that younger students, even though they may have less clinical knowledge, can still offer a valuable contribution when given an appropriate role. furthermore, the variety of roles can allow certain challenges to be avoided. for instance, if a hospital is deemed to have a lack of supervisors, a commonly faced challenge even during nonemergency times, then medical students can get involved in a nondirect clinical role. several challenges were described as students undertook these roles, including a lack of supervision, a lack of experience, and a negative impact on their mental health. , , , pro-actively addressing these challenges will not only enable any involvement medical students have in the current or any global health emergency to be efficient and effective, but will also reduce any detrimental effect on the medical students' mental health and medical education. our results demonstrate that such involvement in highly stressful situations can lead to anxiety, depressive symptoms, and emotional distress. , , consequently, stress can lead increased severity (very dangerous and contagious compared to very infectious) , greater level of knowledge , , pediatric patient care history of a severe illness to them or family member respiratory transmission compared to contact less than y old medical role (compared to admin role) more than h of previous volunteering natural disaster (compared to an infectious disease) ppe availability training before work travel compensation well run organization table overview of the students' confidence in their skills, knowledge, and education to deal with global health emergencies article id context (self-perceived) percentage of students gouda ( ) sufficiently skilled to respond to an emergency outbreak . kaiser ( ) sufficiently skilled to respond to natural disasters . sufficiently skilled to respond to pandemic influenza . mortelmans ( ) sufficiently educated to help in h n pandemic mortelmans ( ) sufficient knowledge on disease management in disaster situations mortelmans ( ) sufficient skills to deal with infectious outbreak . academic commitments cv improvement and gaining future contacts family health and safety concerns increase self-confidence in sim situations family/social commitments obligation/social responsibility , financial implications professional and skills development inefficiency reduce guilt about less fortunate lack of confidence in skills sense of ethics lack of information needless sacrifice personal health and safety concerns work commitments disaster medicine and public health preparedness to a higher prevalence of university student dropout. to avoid negative mental health impacts, adequate support must be provided to medical students if they are to be involved. this also highlights the need for further research that explores the short-and long-term effects on the students involved, and more specifically, the impact on their mental health and their future careers. ultimately, the roles of medical students might be very context-specific. a limitation of this review is the lack of data providing specific recommendations on the most suitable role of medical students in the differing types of global health emergencies. a further limitation is the paucity of data evaluating the roles medical students have previously undertaken. it is important to ascertain how effective medical students were in the emergency response and whether they made a real impact. therefore, further research into the effectiveness of medical student involvement would be beneficial, and perhaps comparing this to global health emergencies that have not involved medical students. eleven of the articles ( . %) discussing willingness reported a greater willingness than unwillingness among medical students to be involved in the response to pandemics and global health emergencies. only hwang et al. found the opposite pattern of only % of students willing to be involved. this article focused specifically on whether medical students would enter a hypothetical closed area with a highly infectious disease and high fatality rate. of interest, only % of those not wanting to enter stated fear of safety as their reason, and in contrast, % were unwilling to enter due to inefficiency. this highlights the importance of organization when adding medical students to the workforce. obligation to help and social responsibility were the most commonly stated reasons for wanting to help in such situations (chen e, goodman kw, fiore rn. involving medical students in disaster response: ethics, education and opportunity [unpublished pdf]. ; - ). [ ] [ ] [ ] this suggests that medical students believe they "should" volunteer, rather than "want" to. in turn, this can lead to students putting pressure on themselves to help, when they may not feel ready to do so, which will potentially hinder any positive effect they may have on the disaster situation, and could be dangerous for patients. making students aware of both their mental and physical capabilities is essential to ensure that they only volunteer if they are prepared. certain factors encouraged student involvement, including a greater level of knowledge and being trained and receiving travel compensation. the most common discouraging factor was the severity of the event or outbreak. , , , , it is important to consider these factors, specifically by emphasizing encouraging factors, such as travel compensation and training before work. this, along with minimizing any discouraging factors where possible, will ensure the maximum number of medical students will be prepared to volunteer and, thus, increase the size of the workforce. it is vital to support medical students to gain the extra help that is needed, as medical students would be going beyond their role of simply learning and being a student in an already stressful situation. considering ways to decrease stress can help reduce negative mental health effects both during and after the event. factors such as age and previous volunteering experience can be used to help target a specific cohort of medical students to volunteer with specific roles. for instance, initially approaching medical students who are already experienced with volunteering, before approaching the remainder of the medical student cohort if required, may be a more beneficial way of organizing a volunteering scheme. several studies found students reported that their willingness was higher than their knowledge and readiness. , , [ ] [ ] [ ] this illustrates the need to better prepare medical students, who can indeed be a great addition to the workforce in disastrous situations. knowledge about a specific disease is vital to students undertaking both clinical and nonclinical roles, such as raising awareness. this preparation could be spread throughout their medical school education, or delivered immediately before a specific role. , the latter, however, would require further resources acutely during a disease outbreak, which may not be available. the studies discussing willingness were limited by their methodology as they only measured medical students' responses and did not compare with the general population. furthermore, most studies were hypothetical situations and, therefore, students may answer differently if the real situation arose. furthermore, there was no standardized survey of measuring willingness between all studies and this, along with the studies not comparing to a general cohort, limited the ability to carry out a meta-analysis. three articles reported that, although medical students may have been willing to help, they may not have necessarily felt prepared or felt that they knew enough. [ ] [ ] [ ] the ethical considerations of the roles of medical students must be thoroughly explored before students are invited to help, especially where patient care may be compromised. during times of nonglobal health emergencies, the primary role of medical students is education and to learn to be a doctor, which can take between and y. the need to help the workforce in times of crisis must be balanced with the educational and wellbeing needs of the medical student to complete their training. whereas "learning on the job" can be an invaluable experience, the safety of both medical students and their patients must be considered. however, there was considerably less data on this aspect in the evidence base. this rapid systematic review provides an overview of the previous involvement of medical students in global health outbreaks, which, to the authors' knowledge, no other systematic review has previously discussed. the inclusion criteria were kept broad, which allows the results to be generalizable for other future global-health emergencies, as well as the current covid- pandemic. the predefined aims and objectives were answered and previous roles and their appropriateness were summarized. although completing a rapid review may help inform the current covid- pandemic, this study design also has limitations, especially due to time constraints. first, although each included article was discussed and data were extracted by authors, no full formal critical appraisal or risk of bias tool was used. second, due to the data not being sufficiently homogenous, a meta-analysis was not possible. third, gray literature was included, which may yield lower quality evidence; however, on balance, it provided an invaluable insight into previous roles that had taken. the fact that medical students are the authors of this review is both a strength and a limitation. the authors are themselves experiencing the possibility of being involved in the current covid- pandemic and, therefore, have insights into the difficulties and lack of data about this process. much has been written on previous roles students have taken in previous situations, and this can be used to inform future policy regarding covid- and future global health emergencies. when designing the role itself, the willingness and preparedness of the medical students should be strongly taken into account. this will ensure specific roles are safe and within appropriate student competencies. medical students should be given clinical roles within reason, and educational and social media roles may be given for the less clinically confident. this highlights the importance of co-production and including students themselves when planning these roles. the authors of this review experienced firsthand the difficulty in defining roles for medical students in the current covid- pandemic, within their own universities and hospital trusts. this highlights the lack of robust policy and knowledge surrounding this topic, and the consequent unnecessary delay in the use of a skillful resource. we thoroughly encourage governments to have predefined policies for medical schools if such events arise again. an infographic was made to summarize the findings of this review (figure ). future research to both describe and evaluate the effectiveness of medical students' roles during the current pandemic should be carried out to help guide future pandemics. this research should also encompass the safety of these roles and the shortand long-term effects on the medical students themselves. furthermore, there is a dearth of literature on the ethical aspects of medical student involvement and duty during such situations. this has been discussed when looking at residents/ junior doctors participating in such situations, but not for the medical student cohort. finally, this area of research can be expanded to provide information on the role of other healthcare students in global health emergencies, namely nursing, pharmacy, dental, and veterinary students. medical students are a willing and resourceful potential addition to the healthcare workforce during global health emergencies. their involvement is vast and many roles have been identified; however, adequate and proactive support must be provided to help them overcome any challenges they may face. choosing the perfect role is very subjective to each emergency. therefore, it is vital to consider available resources, students' opinions, and the nature of the emergency itself when planning roles. future research should be targeted at filling important gaps in the literature discussed above, including evaluating the effectiveness of different roles undertaken by medical students in global health emergencies and the ethical issues regarding the appropriateness of the medical students' involvement. the international federation of medical students' associations. ifmsa policy proposal meaningful youth participation medical student research: 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trajectory of university dropout: investigating the cumulative effect of academic vulnerability and proximity to family support are saudi medical students aware of middle east respiratory syndrome coronavirus during an outbreak? planning and incorporating public health preparedness into the medical curriculum using an h n vaccination drive-through to introduce healthcare students and their faculty to disaster medicine it is time to prioritize education and well-being over workforce needs in residency training or student doctor[title/abstract] or medical student*[title/abstract])) and (pandemic[title/abstract] or disease outbreak[title/abstract] or disaster medicine[title/abstract] or epidemic[title/abstract] or acute respiratory infection[title/abstract] or severe acute respiratory syndrome[title/abstract] or global health emergency ovid: ((medical student or student doctor or medical student*) and (pandemic or disease outbreak or disaster medicine or epidemic or acute respiratory infection or severe acute respiratory syndrome or global health emergency or public health emergency)).ab,ti all authors have completed the icmje uniform disclosure form at http://www. icmje.org/coi_disclosure.pdf and declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous y, no other relationships or activities that could appear to have influenced the submitted work. the lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. key: cord- -yxl a u authors: yadav, uday narayan; rayamajhee, binod; mistry, sabuj kanti; parsekar, shradha s.; mishra, shyam kumar title: a syndemic perspective on the management of non-communicable diseases amid the covid- pandemic in low- and middle-income countries date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: yxl a u the global coronavirus disease (covid- ) pandemic has greatly affected the lives of people living with non-communicable diseases (plwncds). the health of plwncds worsens when synergistic epidemics or “syndemics” occur due to the interaction between socioecological and biological factors, resulting in adverse outcomes. these interactions can affect the physical, emotional, and social well-being of plwncds. in this paper, we discuss the effects of the covid- syndemic on plwncds, particularly how it has exposed them to ncd risk factors and disrupted essential public health services. we conclude by reflecting on strategies and policies that deal with the covid- syndemic among plwncds in low- and middle-income countries. the entire world has been affected by the coronavirus disease (covid- ) pandemic caused by severe acute respiratory syndrome coronavirus (sars-cov- ), which has led to thousands of deaths each day. the covid- pandemic is one of the greatest public health calamities since world war ii and, despite best efforts, has been challenging to control ( ) . recognizing the rapid spread of covid- and the threats it poses, the world health organization (who) declared it an international public health emergency on january . this allowed countries to exert maximum effort and allot resources to limit the rapid transmission of sars-cov- . despite the low fatality rate and government efforts, people are living in uncertainty and fear, as there is no vaccine for covid- . covid- has weakened healthcare systems and economies, emptied open spaces, and filled hospitals ( ). the pandemic has separated many people from their family, friends, and workstations and has severely disrupted modern life. to mitigate this unprecedented pandemic, physical, and social distancing along with nationwide lockdowns and restrictions, have been implemented for the past few months in several countries ( ) . covid- is creating a profound impact on all parts of the community, including the physical and mental health of the public. the growing pandemic is augmenting existing mental health problems ( ), including loneliness, anxiety, paranoia, panic, depression, and hoarding, with long-term psychosocial impacts ( ) . social distancing, stress, and fear are the main factors behind these psychological problems, leading to a global increase in suicides ( ) . self-isolation and quarantine measures disproportionately affect people, especially older adults, migrants, laborers, refugees, people with chronic diseases, and marginalized and vulnerable populations ( ) . the covid- cataclysm has become the most serious problem worldwide, and its consequences have left no one untouched ( ) . the effects of a pandemic intensify due to its diverse nexus of intertwined biological and socioecological factors. this diverse nexus was coined a "syndemic" by medical anthropologist merrill singer in the s to describe the relationship between hiv/aids, substance use, and violence ( ) . a "syndemic" is defined as a synergistic interaction between socioecological and biological factors (figure ) , resulting in adverse health outcomes ( ) . the covid- pandemic has escalated into a syndemic due to several driving factors, such as overcrowding, loneliness, uncertainty, poor nutrition, and lack of access to health services; consequently, depression, suicide, domestic violence, and psychiatric illnesses have significantly increased ( ) . social determinants of health, such as poverty, social inequality, social stigma, and the environment where people live and work, greatly affect the intensity of the syndemic ( ) . additionally, xenophobia, ostracism, and racism are reported in many places. generally, people living in countries with higher social and economic inequalities have more coexisting non-communicable diseases (ncds) and are therefore more vulnerable to the syndemic impact of covid- . we argue that, for people living with ncds (plwncds), covid- is considered a syndemic-a synergistic pandemic that interacts with various pre-existing medical conditions and social, ecological, and political factors and exacerbates existing ncds. studies have reported higher proportions of frailty ( , ) , malnutrition ( ) , psychological problems ( ) , and coinfections, including antimicrobial resistance pathogens, among plwncds ( ) in low-and middle-income countries (lmics). ncds have been recognized as a key risk factor for covid- patients ( ); however, vulnerability to catching sars-cov- increases in the presence of other pre-existing factors. prevailing inequalities in the social determinants of health, including poor social, economic, and environmental conditions (e.g., social behavioral factors, physical environment, social marginalization, and supportive government policies; figure ) , have an impact on various aspects of life such as health, wellness, and financial status. for example, plwncds with comorbidities and higher social and economic deprivation are less likely to access health services during this pandemic. this results in worse health outcomes, such as poor quality of life, mortality, suicide ( , , ) , and increased hospitalization due to poor self-management ( , ) . during the covid- pandemic, plwncds from disadvantaged groups are less likely to receive healthcare compared to plwncds from socially advantaged groups. the disadvantaged population (particularly individuals from low socioeconomic conditions) have a high chance of falling sick ( ) , dying, and experiencing catastrophe. furthermore, socioeconomically deprived individuals who were dependent on daily wages have lost their jobs; this has pushed them further into poverty and poor health ( ) . a synergistic association between the severity of covid- and ncds was reported in china ( ) , which shows the negative effects of this syndemic. this suggests the urgency of a paradigm shift from a single-condition approach to a syndemic approach to tackle the current and future impacts of pandemics among plwncds in lmics. the pandemic is unlikely to end soon, and it is difficult to predict the arrival of the next pandemic, but the syndemic will certainly continue in lmics. in this paper, we discuss covid- among plwncds, exposure to ncd risk factors, and the disruption of essential public health services for ncds. it considers literature on this topic, following a search on google and pubmed to identify publications that considered populations with covid- and ncds. we conclude by reflecting on strategies and policies that deal with the covid- syndemic among plwncds in lmics. the global covid- pandemic has resulted in , , cases in countries and territories around the world and two international conveyances, with , fatalities as of july , ( ) . covid- cases are decreasing in many countries, but the opposite is true in lmics such as india and brazil. many seriously ill covid- patients had multiple comorbidities ( ) ; for instance, . % of those who died in hospitals in italy had comorbidities. the case fatality rate increases with age, especially in countries with a high percentage of older adults. the comorbidities were mostly ncds, such as hypertension, diabetes, cardiovascular disease, and chronic lung disease, especially chronic obstructive pulmonary disease ( , ) . the prevalence of comorbidities is higher among covid- patients compared to the general population who are not infected with coronavirus; for instance, % of the covid- patients in india and % of the covid- patients in china had comorbidities ( ) . the prevalence of comorbidities is expected to be similar in other lmics where the prevalence of ncds is high; however, there is a lack of literature on this topic from lmics. the health condition is more severe and mortality is higher among older adults with ncds ( ) and people with bacterial infections caused by antibiotic resistant pathogens, such as superinfections ( ) . ncds cause around % of deaths worldwide and are the primary cause of death in southeast asia among those aged to years ( ) . lmics have a large ncd burden; in some lmics, such as india, there is an early onset of ncds, thereby increasing the risk of covid- among young individuals ( ) . the addition of covid- to pre-existing ncds results in increased morbidity and mortality ( ). ncds can exhibit several characteristics with infectious manifestations, including parameters like a proinflammatory state and compromised innate immune response ( ) . this condition is further worsened because many plwncds have been deprived of treatment for their diseases since the onset of the covid- pandemic. preventive methods for this pandemic, such as physical/social distancing, lockdowns, self-isolation, and quarantine, may increase exposure to ncd risk factors, such as the increased use of tobacco products and alcohol as coping strategies ( ), increased reliance on unhealthy processed foods and barriers to physical activities ( ), which lead to weight gain ( ) . these factors increase the incidence of ncds and related mortality ( ) . moreover, financial crises and the lack of social contact might enhance the burden of anxiety and depression among plwncds. the economic slowdown predisposes people to malnourishment, which further increases the risk of infectious diseases ( ) . since the covid- pandemic began, prevention and treatment services around the globe have been severely impaired, and the disruption is worse in lmics. the results from a survey conducted by the who in countries ( ) revealed that plwncds were not able to access services for their health conditions, which made their lives even more difficult during this crisis. more than % of the surveyed countries reported partially or completely impaired services for ncds and related complications, particularly after the covid- trajectory changed from sporadic to community transmission. this is supported by the stories and pictures of plwncds captured in the news and social media of lmics, where people were unable to access basic medicines or care (particularly in areas with protracted lockdowns) for their chronic conditions. this problem is exacerbated by the reassignment of health staff from ncd facilities to covid- in all surveyed countries ( ) and the disruption of medical supplies and diagnostics as a result of nationwide lockdowns ( ) . for example, in india, some outpatient services have been temporarily closed, and hospitals have been converted into designated covid- care homes ( ) . this arrangement will have a further adverse effect on access to healthcare services and treatment adherence by plwncds. similar painful stories regarding plwncds have been reported in the news and social media platforms of many lmics, such as nepal, bangladesh, brazil, pakistan, ghana, and iran. governments in various countries have made efforts to focus on ncd services while tackling covid- , but only % of low-income countries have done so compared to % of highincome countries (hics) ( ) . this shows the global impact of covid- on the disruption of healthcare services for ncds. the interaction of covid- with other biological and social factors appears to increase the risk of complications, worsen health outcomes, and intensify the burden on healthcare professionals and health systems. on the one hand, there is a global rush to respond to covid- by increasing intensive care unit beds, installing ventilators, extending lockdowns, and adopting other containment measures. on the other hand, there is a disruption of routine health services, such as screening and diagnosis, supplies of essential medicines, and access to health service providers and support services. the covid- syndemic and other conditions have not only posed a challenge to health systems but have also exposed gaps within the healthcare delivery system in many hics (e.g., italy, spain, and the united states) and lmics (e.g., pakistan, india, nepal, bangladesh, mexico, and brazil). due to covid- , the priorities of health services have shifted; as a result, the progress required to achieve sustainable development goals is threatened ( ) . in the subsequent section, we describe strategies that are essential to overcoming and managing the syndemic condition. we divide these strategies into four broad categories (figure ) . the sudden lockdowns imposed by authorities caused panic in many countries. to avoid such situations, there should be a supply of basic needs, such as groceries and sanitary items. home delivery is an important strategy that can be implemented with the help of volunteers, especially for older adults and people with disabilities. misinformation and fake news on social media platforms are fuelling this panic. people should follow information from trusted sources such as government guidelines. additionally, authorities should disseminate the appropriate information to the general public in a timely manner. plwncds should be encouraged to monitor their symptoms, practice self-care, adhere to medication, seek healthcare services including counseling, practice physical distancing, wash their hands with soap, and wear masks. providing information on self-management behavior changes for ncds and covid- through sms and social media platforms is an important step. in this situation, health literacy (having the necessary information and skills to manage health) and activation (motivation and the ability to take action) can play an important role ( , ) in self-management ( ) of conditions among plwncds in lmics. promoting both the health literacy and empowerment of plwncds would enable patients to navigate health services, use technology to contact healthcare providers, develop problemsolving skills, and adhere to healthy lifestyle behaviors ( ) . healthy lifestyle activities must be promoted, such as eating nutritious foods and engaging in physical and wellness activities. individuals should have access to open spaces and be allowed to exercise at scheduled times while maintaining all precautionary measures, and plwncds could be given timecards for physical activity. the expansion of existing community health worker (chw) roles can be crucial to the self-management of ncds and covid- and to delivering basic services among plwncds during this extreme health workforce shortage, particularly in lmics with weak health systems. recovered covid- patients can also spread information on health and self-care management and help debunk the myths and lessen the stigma related to covid- . although countries (mostly developed ones) are trying to provide care through telemedicine, it is still in the formative stage. while telemedicine is a boon for developed nations when it comes to the diagnosis, treatment, self-management support, and surveillance of conditions, lmics with fragile health systems often struggle to launch telemedicine services. using digital healthcare platforms in the health system ( ) would greatly increase access to the services and information required by plwncds. this would, in turn, improve the management of chronic conditions and provide relief from emotional turmoil and stress ( ) . in fragmented health systems, chws can promote coordinated care by improving access to care and providing navigation support ( ) . chws can also carry out surveillance of risk factors and implement preventive and self-management strategies for plwncds, who are at high risk of covid- . potential chw roles in covid- management include community engagement, community sensitization, promoting isolation and quarantine, and performing contact tracing ( , ) . despite their huge potential in pandemic management, chws have been underutilized in the covid- pandemic, especially in countries where chws are available, such as bangladesh, india, and nepal. however, before involving chws in the covid- response, they must be provided with appropriate training and adequate personal protective equipment ( ) . while responding to covid- , the governments of lmics have failed to ensure health services for plwncds because of the blanket lockdown approach. insufficient attention has been paid to the unnoticed drivers of covid- -related mortality among plwncds. while governments enforce mitigating measures during this pandemic, they also need to develop strategies to map national-level data on ncd patients, as such data do not exist in many lmics. there is also a need to prepare care pathways for severely ill plwncds by engaging private and public healthcare institutions and delivering basic health services (e.g., screening, medical checkups, and pharmacy services) at the community level via mobile primary healthcare vans. in many lmics, out-ofpocket (oop) health expenditures are high and will rise further during the covid- pandemic ( ) . to reduce the burden of oop due to covid- , authorities should make provisions for free diagnostic and treatment facilities and focus on equitable, accessible, and affordable healthcare. these measures will prevent the deterioration of health among plwncds amid the covid- pandemic. a situational analysis of available resources and resource planning must be carried out. supportive packages should be provided to vulnerable groups, such as older adults, people with disabilities, and the unemployed. involving the private sector, civil society, academia, non-governmental, and governmental organizations through intersectoral coordination and teamwork would address the situation with a syndemic lens. hics can help lmics in setting up / helpline support to provide essential information and guidance related to the availability of services and contact in case of emergency. authorities should also consider imposing different levels of restrictions by mapping the incidence and active cases of covid- , such as by designating red, yellow, and green zones. providing an uninterrupted supply of funds is a major challenge for lmics during the covid- pandemic. international organizations, philanthropists, and industrialists through their corporate social responsibility should come forward to help countries facing a financial crisis. highquality research and data on effective interventions to prevent the spread of infection and treatment of active cases are also needed. moreover, authorities should impose taxes on items such as sweetened beverages, tobacco, and alcohol to subsidize prices or lower taxes for nutritious food items and ease movement restrictions for food production, processing, and delivery, which will indirectly lessen the use of unhealthy products. ncds increase vulnerability to covid- , and covid- increases ncd-related risk factors. the covid- pandemic may not be the last to threaten the global community. therefore, there is a need to understand the drivers of the syndemic and design safety nets. the health system must address not just one or some medical problems but ensure holistic care for those that need it, particularly plwncds. care for plwncds, who are at most risk of covid- , must be included in national response frameworks and plans so that the government can protect citizens' health and well-being during the current covid- pandemic and for similar crises in the future, otherwise, the interaction of covid- and ncds will result in disastrous effects that could be difficult to handle given the preexisting stress on healthcare delivery systems and impede progress in achieving the sustainable development goals. the governments of lmics are crippled by a lack of technical and financial resources to address this overwhelming problem. tackling the covid- syndemic is a matter of urgency. funding bodies that advocate for and want to be part of a change in lmics need to invest in prevention and health promotion programs that could address issues within a syndemic framework ( ). government agencies positioned to develop and implement policies must understand that asking citizens to sacrifice without providing appropriate support packages will not work. rather than gearing up for a vertical approach, governments, concerned stakeholders, development partners, and civil society must build synergy across healthcare platforms to tackle this crisis through a holistic approach. if they fail to do so, the post-pandemic era could experience a great divide in health equity that could be much worse than ever before, undoing the progress made in developing healthcare policies and strengthening healthcare systems and infrastructure. evidenceguided decisions must be made to overcome this formidable crisis in lmics. the original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s. association between climate variables and global transmission of 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non-communicable diseases in low-and middle-income countries: a scoping review how health literacy and patient activation play their own unique role in self-management of chronic obstructive pulmonary disease (copd)? covid- : health literacy is an underestimated problem how to fight an infodemic global preparedness against covid- : we must leverage the power of digital health a patient navigator intervention to reduce hospital readmissions among high-risk safety-net patients: a randomized controlled trial community health workers for pandemic response: a rapid evidence synthesis prioritising the role of community health workers in the covid- response healthcare providers on the frontlines: a qualitative investigation of the social and emotional impact of delivering health services during sierra leone's ebola epidemic uny conceived the idea. uny, br, and sky drafted the manuscript. sp and skm provided the significant inputs.all authors approved the final version of manuscript. authors acknowledge the assistance of scientia prof. mark fort harris (executive director, centre for primary health care and equity, unsw, sydney) for providing expertise inputs in this piece. we greatly acknowledge mr. bhupendra lama from central department of microbiology, tribhuvan university, nepal for contribution in design of figure . key: cord- -n yqw authors: falicov, celia; niño, alba; d'urso, maria sol title: expanding possibilities: flexibility and solidarity with under resourced immigrant families during the covid‐ pandemic date: - - journal: fam process doi: . /famp. sha: doc_id: cord_uid: n yqw the novel coronavirus has added new anxieties and forms of grieving to the myriad practical and emotional burdens already present in the lives of underserved and uninsured immigrant families and communities. in this article, we relate our experiences since the covid‐ crisis to the lessons we have learned over time as mental health professionals working with families in no‐cost, student‐managed community comprehensive health clinics in academic‐community partnerships. we compare and contrast the learnings of flexibility of time, space, procedures or attendance we acquired in this clinical community setting during regular times, with the new challenges families and therapists face, and the adaptations needed to continue to work with our clients in culturally responsive and empowering ways during the covid‐ pandemic. we describe families, students, professionals, promotoras (community links) and it support staff joining together in solidarity as the creative problem solvers of new possibilities when families do not have access to wifi, smart phones or computers, or suffer overcrowding and lack of privacy. we describe many anxieties related to economic insecurity or fear of facing death alone, but also how to visualize expanding possibilities in styles of parenting or types of emotional support among family members as elements of hope that may endure beyond these unprecedented tragic times of loss and uncertainty. serving underserved and vulnerable populations utilizing a humanistic transdisciplinary empowerment model with the community as teacher in the fields of medicine, pharmacy, dentistry, nursing, acupuncture, law, and social work. in addition to general primary care, specialty services of oncology, nephrology, neurology, gynecology, and mental health are provided by volunteer professionals supervising teams of students. there is also a legal clinic serviced by law students and volunteer attorneys that provides consultation, advice and referrals. the medical students acquire training in family medicine with the underserved through comprehensive patient care under the supervision of attending physicians, take didactic interactive courses related to underserved healthcare, learn community advocacy, and have ongoing opportunities for self-reflection (beck, ; wortis, beck, & donsky, ; beck et al., b) currently, there are four srfc clinics in different areas of the city of san diego providing services to a primarily a latinx population of mexican origin. latinx families account for a disproportionate share of uninsured and underinsured americans. lacking affordable and quality health and mental health care, and services that are culturally and contextually attuned, many latinx families are deprived of equal and just treatment (falicov, ; national council of la raza, ; ruiz, ) . three of the clinics offer mental health services. the clinics operate in spaces lent by religious or academic organizations and are open for around hours per day, one day per week, and on different weekdays depending on the location. the clinics have, for the most part, been at the same locations for many years. this evidences a particular relation between the clinics and the communities they serve. srfcs have built long-lasting partnerships of mutual respect and trust with local organizations to share physical and service resources. also, the individuals and families who attend the clinics rely on their consistency. although the covid- pandemic has affected virtually all areas of the world, manifestations are different depending on the location. in san diego, infection and mortality rates have been low compared to other regions of the country. despite recent acceleration, california still has a relatively low mortality rate ( per , people, compared to in new york city, and nationwide) (new york times, june , ) . within california, however, san diego county has one of the highest infection rates (number of positive cases per , people) and, as of june , there were deaths reported (new york times, june , ) . some factors that might have contributed to these rates in san diego are early adoption of shelter-in-place measures, and lower population density. despite these mitigating factors, disparities persist. the health and economic effects of the pandemic have impacted more severely the hispanic, black, and pacific islander communities in san diego county. hispanics account for % of the county population, but constitute % of cases. in addition, the infection rates for blacks and hispanics are respectively two and four times the rate for the white population in the area (city news service, june , ). these discrepancies can be partially explained by the overrepresentation of hispanics and blacks among essential workers and in jobs that require direct contact (e.g., food service, retail, childcare, transportation, and postal services). a study by the san diego association of governments (sandag, ) found hispanic and black families are three times more likely to live in the zip codes most affected by both and unemployment than their white counterparts. these areas are in the southern portion of san diego county, closer to the u.s.-mexico border, and are the places from which the srfcs receive most of their patients. the impact of covid- and its ramifications has also directly affected the provision of srfcs services. during covid- , the srfc physicians, pharmacy team, medical students, staff, volunteers, mental health team, social workers, and promotoras (experienced community members who are core staff and act as "trust bridges" to the community (beck, ) ) have come together to continue to provide health, mental health care and emotional support through telemedicine and delivery of medications and food to patients' homes. attending physicians, students, support personnel, and the pharmacy team are onsite. however, all patient visits are done by telehealth (phone or video) which has been both challenging and rewarding. our patients have been shown to be some of the most food insecure in the nation. students have created, in partnership with feeding america and the supplemental nutrition assistance program, a system where patients are screened for food insecurity and receive two bags of healthy food during medical visit (smith et al., ) . during covid- initially, families came to the clinics' this article is protected by copyright. all rights reserved parking lot while students and physicians brought medicine and food to their cars. now, for further protection, these are delivered to patients' homes by students . being part of the srfcs has always been inspirational and life-transformative . coping with medical students, physicians, social workers, interpreters, psychiatrists, psychotherapists and support staff in solidarity with each other and with patients have embraced new and innovative forms of patient care while developing clinical skills despite the challenges of social distancing. immigrant latinx patients are more likely to seek or accept mental health services within a community medical setting than independently seeking these services when they suffer depression, anxiety, trauma or relational conflicts (falicov, ; valdez et al., ; vega et al., ) . mental health distress may also manifest in different "idioms of distress" and somatic complaints such as headaches, stomach aches or fatigue that are brought up with health practitioners (falicov, a) the srfcs have had, almost from their inception in , psychiatry clinics with volunteer psychiatrists in teaching roles guiding medical students in diagnostic evaluation and psychotropic prescribing skills. there were also limited psychotherapy services provided. in , the first author, a bilingual bicultural psychologist and family therapist began her involvement with the clinic by volunteering to provide culturally and contextually attuned individual and family therapy to the medical patients in one of the clinic locations (beck, dominguez, & falicov, a) . after a few years of increasing referrals, the need for expansion of psychotherapy services became evident. she gradually recruited volunteer psychiatrists, psychologists and marriage and family therapists who provide psychotherapy in three of the four clinics today. this is how the second and third authors became involved in this project (falicov, dominguez, gonzalez, d'urso, abrams, & mcclish, ) . when conducting psychotherapy sessions, it becomes clear that for many families financial, housing, food or transportation needs are overwhelming stressors that must be addressed urgently (sousa & rodriguez, ) . in such cases, we coordinate care and advocacy with our social work team. the approach of the mental health team is based on a systems ecological orientation that respects cultural diversity without relying on ethnic stereotypes, and promotes empowerment by supporting strength-based rather than deficit-oriented approaches (falicov, ) . identifying strengths has empowering effects, and more so in situations of despair or hopelessness in families and communities who are economically marginalized and culturally or racially discriminated against. we center clients' voices as the experts on their needs and their preferred ways to address them. we favor a ground-up approach to learning from clients about their cultural preferences and their contextual stressors, endeavoring to move from professional-led to client-led solutions. in this respect, the mental health services share the srfcs philosophy inspired by tervalon and murray-garcia ( ) 's concept of cultural humility as a commitment to self-awareness by the providers in order to redress power imbalances and develop non-paternalistic partnerships. students and practitioners adhere to the premise that the patient or the client is the teacher/expert on their own lives. recent studies support the effectiveness of ground-up and shared-decision making approaches in the treatment of ethnic minorities (falicov, nakash, & alegría, in press; fraenkel, ; parra-cardona et al., ) . modifying existing mainstream psychological practices or finding innovations that consider culture and context can result in increased access, appeal and retention in mental health services (falicov, b; kanel, ) . the psychotherapy team shares strength-based, constructionist approaches to cultural diversity and social justice as a philosophical base for community services. within this umbrella, the conceptual frameworks of the therapists include family and community systems-oriented, structural, collaborative, narrative, solution-focused, emotion-focused therapy, cognitive-behavioral, relational psychoanalysis or experiential approaches. some therapists use these approaches flexibly, depending on the needs of the case. they adhere to the notion that it is possible to address social justice through a variety of approaches (mcdowell, knudson-martin & bermudez, ) . our priorities in selecting mental health volunteers are based on what we believe are healing common factors: professional excellence, passionate community concern and dedication, skills to listen collaboratively and respect local knowledge, appreciation for the ecology of families and, whenever possible, bilingual/bicultural skills. this article is protected by copyright. all rights reserved recently, medical students have been involved in psychotherapy sessions and report a better understanding of the process. they reported appreciating the collaborative nature of the sessions which has helped them modify their views of therapy as being practitioner-led and prescriptive. these exposures may increase students' cultural and contextual understandings of our population, and model reflective skills to use in their own practice as physicians. the current pandemic starkly confirmed the far-ranging inequalities that impinge on the survival of people of color. inequalities in access to the medical system cause a host of untreated or undertreated health conditions (diabetes, hypertension, heart disease, obesity) that decrease immune responses to infection. exposures and vulnerability to infection are intensified by dangerous work conditions and essential jobs, overcrowded housing, and neighborhoods that lack protective supplies and preventive information. these inequalities are further intensified for under resourced immigrants who lack health insurance, experience job instability, unstable housing, underemployment and underpayment, language and culture differences, and diverse beliefs about health and cure. the case examples illustrate how some of these intensified anxieties were addressed in therapy. lucía, , was followed up medically via telehealth. she told her physician that she had become depressed because her son, the main economic supporter of the family, had lost his job at a restaurant that closed due to social-distancing policies. because of this, the son had to move in with his mother and sister. in the initial video session, the therapist perceived that lucia´s depression was related to quarreling between her children. the therapist suggested inviting her children to the next video session to discuss their worries and find ways to support each other. lucía saw this as a way to help her grown children relieve their current distress. during the family session, it became clear that lucia conceived of her role in hierarchical terms as a parent bent on solving her offspring's problems with suggestions and advice. rather than appearing receptive, these attempts seemed to irritate her children. understanding the family interactions from a culturally sensitive, structural family therapy viewpoint, the therapist praised the mother for her maternal good intentions but created an age-appropriate boundary. the main therapy message reversed the idea that the mother needed to resolve their conflicts like she did when her children this article is protected by copyright. all rights reserved were younger. rather, the new losses of security and uncertainty brought about by the pandemic called for increased family cohesion and solidarity initiated by the young adults. covid- in immigrant family and community contexts may evoke new anxieties in the face of uncertainty, such as prospects of going to a hospital without health insurance, leaving a job because of illness, or asking for help from an already stressed social or family network. eugenia, a -year-old client who was attending the clinic for several health issues, and who had received psychotherapy for anxiety symptoms in the past, saw an exacerbation of her anxiety due to covid- . phone sessions were scheduled for psychotherapy. phone was preferred over video because it allowed eugenia the freedom to walk to an area in her home where she had privacy to discuss her concerns. video sessions were discarded because they would require using the only computer in the home, located in her daughters' room. eugenia knew that her physical conditions made her more vulnerable to complications related to the novel coronavirus. she was also aware that covid- treatment included isolation to avoid contagion. as a monolingual spanishspeaking immigrant relying on a reduced circle of love and help, the idea of being away from her family and possibly dying alone in a hospital in a strange land was devastating for eugenia, and led to intense fear and anxiety symptoms. her therapist (second author) engaged the collaboration of eugenia's physician via phone. with the information given by her physician, eugenia understood better the symptoms of covid- and the ways this disease propagates. this knowledge was empowering as eugenia felt better prepared to protect herself and her daughters, although this protectiveness, perhaps a cultural preference, made her still reluctant to share her fears with them in a family session. emotionally-focused interventions such as empathic reflections and emotional heightening gave eugenia the space to fully express her fears. from the perspective of this therapeutic model, our sense of felt security comes from our closest bonds. to increase eugenia's sense of felt security, these bonds were explored. eugenia expressed that her strength comes from the love and connection between her and her two adult daughters, who have always supported each other through thick and thin. eugenia also said that her faith in god was a source of comfort and hope, and that praying and "putting things in his hands" was something that filled her with peace when she felt afraid. interestingly, this was a new therapist for eugenia this article is protected by copyright. all rights reserved whom she only met on the phone. eugenia expressed how comforted she felt by the conversations with the therapist and how much she wished she could get to know her in person soon. immigrants suffer a series of traumas during the migration process: losses of family, language, and culture; unwelcoming reception by the host culture, and persistent economic vulnerability (falicov, ) . while immigration is a stressful process per se, the anomic conditions of isolation caused by fear of discrimination and detention, even for those immigrants with legal or quasi legal status, is an insidious psychological stressor in today's intense official persecutory anti-immigrant climate. most immigrants have lost many valuable relationships and cultural anchors. rebuilding social and family closeness, community supports, religious participation and other cultural rituals are protective elements against isolation, separation and suffering after immigration (falicov, ; sluzki, ) . during covid- , the need to maintain social distance precisely when physical and social presence are needed the most, blocks the protective in-person family and community elements for immigrant families, such as church going, or family or neighbor visiting. these experiences that lend connection, belonging and affirmation of identity become background rather than foreground because of the need to maintain social distance. physical connection may also be constructed culturally in non-verbal habitual ways. in most latinx groups, kissing, hugging or shaking hands are thought to be signs of affection and sociability often extended to people with whom one has a prolonged relationship, including psychotherapists, a cultural characteristic that has been dubbed "personalismo" (falicov, ) for this reason, we inquire about the effects of social distancing when talking with our clients electronically. also, replacing physical expressions of affection with caring words from a therapist during covid- may be comforting. these include "i hope you and yours stay healthy and safe", or "i hope you all don't worry too much", or even "i send hugs to all of you". a statement from a therapist to clients such as "know that you can always call on me" has more poignant implications at this time. we also regularly inquire about the place of religion, spirituality and faith in our latinx clients' lives, as we have learned from them about the powerful contribution of religious beliefs and practices to their well-being, particularly in hard times (falicov, a; falicov, ) . church-going and its social resources are drastically curtailed during covid- . however, silent and shared prayer this article is protected by copyright. all rights reserved or lighting candles as expressions of trust in god's will continue to be a central resource for our clients at this time. covid- stressors are not always the focus of the psychotherapy sessions. for some clients, the sessions continue to be largely focused on previous concerns, and even some new expanded possibilities opened by the sheltering-at-home situation. in fact, as practitioners inquire about possible concerns related to the pandemic, clients and promotoras have reported that some clients have found ways of adapting to the uncertainty of the situation without their lives getting dramatically worse. crowding and confinement, which may be stressful experiences for resourceful families during the pandemic, may be less onerous to our clients. enduring poverty, immigration, or language and transportation limitations, these families have adapted over time to a much more limited lifestyle situated almost exclusively in the smaller ecology of their neighborhood. also, it is possible that given their experience of frequently coping with multiple sources of adversity, clients have developed skills and family resiliencies (walsh, ) that are being put in practice as they face the effects of the pandemic. physicians' support. the care provided by the physicians and the students at the srfc clinic is a stellar example of knowing and caring for the whole person of each patient, their families and communities. the positive attitudes towards our services have ensured that we have frequent referrals for psychotherapy. studies have shown that the success of mental health services in primary care settings is dependent on physicians' attitudes (beacham et al., ) . attending physicians working with medical students at the clinic identify when a patient needs mental health services either because of coping with a difficult medical illness, because the patient's health complaints are insufficient to explain their degree of emotional distress, or by conducting regular screenings for depression and anxiety (soltani et al., ) . in solidarity, during covid- , physicians and students have continued to identify and promptly refer to us those patients in need of mental health attention. locating mental health services in the community. the health clinic where the first author originally provided psychotherapy services operated for many years in two empty classrooms and mobile trailers on the grounds of an inner-city public school and sometimes at a nearby community center. three of four clinics function in neighborhood churches. the physical location of the clinics in this article is protected by copyright. all rights reserved a church space with waiting rooms that have chairs close to each other invites social viewing and conversation among the patients. in one of the locations, the room has a table where patients, while waiting, can make crafts under the guidance of a talented community facilitator. next to it, shelves that offer water bottles, chips, cookies, coffee and sandwiches at minimal cost are handled by volunteer patients. medical students get energetically engaged with the patients in these spaces. the ambiance lends a collective sense of belonging, privacy and even ownership. many patients tell us that they have found in this environment an extension of "family", perhaps that is the reason why patients bring traditional home-made foods for the students, staff and other patients when possible. many describe these actions as their way to "give back" and it is nurturance appreciated by all. since covid- , this place of encounter has been temporarily lost. the new ways in which the community may be connecting and caring for each other are not evident to us, as we used to witness in the waiting rooms. knowing that the network experiences that happen face to face contribute to the clients' sense of community, we continue to brainstorm creative ways to provide spaces for collective connection. aspects of our professional community of care are recreated when our team of students, providers and staff make the effort to continuously check in with our patients and families using electronic means. patients may have more than one appointment per day with physicians and mental health or social work service. this somewhat evokes what a visit to the clinic pre-covid- was like. virtual coordination has been indispensable to smoothly deliver these combined services. this coordination often requires several staff involved: an it person, a student who enters the appointments in the electronic clinic records, a promotora who follows up via phone with the patient and several practitioners. these efforts rely on systems that have become more complex but had already been established before covid- . patients have reported that these efforts make them feel that they still have a community that cares and provides safety and security. flexibility of physical space for psychotherapy sessions. within the church-clinic settings, psychotherapy sessions are conducted in a variety of places according to availability. it could be sitting at a small table in the same room with other tables occupied by physicians, students and interpreters engaged in medical appointments, or in private all-purpose rooms that house file cabinets and supplies that need to be fetched by someone, briefly interrupting the session. the sanctuary of the accepted article church can be used too, where at one extreme there may be an acupuncture session in progress with patients in massage tables, and at the other extreme, near the altar, the psychotherapy session is taking place. the limitations in physical resources require providers to be flexible and adaptable. we find ourselves performing the balancing act of procuring the safety, confidentiality, and privacy necessary for conducting psychotherapy sessions while sharing the physical space with other clinicians. seating arrangements, screens and other physical barriers, along with softer voices aid in creating an atmosphere of privacy and confidentiality conducive to psychotherapy for our clients in the midst of space limitations. physical location was radically disrupted by covid- . the space that offered both the possibility of social interaction and the privacy to discuss one's concerns is no longer available. appointments need to be conducted now via telehealth with many barriers to be bridged. the flexibility gained by therapists functioning in a weekly changing space has become an invaluable asset in these changed circumstances. other forms of flexibility discussed below have always been needed and have become even more salient during this pandemic. clinical procedures have an implicit or explicit cultural expectation that the client will show up for scheduled appointments regularly, will be on time, will not overpass the allotted talk time when the end of the therapy hour approaches or will bring other family members as planned for family sessions. contrary to those mainstream cultural expectations of punctuality, regularity and prompt response to calls, many under resourced families are not always able to maintain a regular attendance and sometimes they only come sporadically. other times they just do not show up, without giving notice because they could not afford to renew their cell phone card, or their car broke down or they did not have money for public transportation. sometimes they do not bring another family member to the session as planned because they could not find their spouse or their adult son because he had just gotten an hourly job after months of searching. sometimes clients come two hours early because that is when they could get a ride. other times they come two hours late because a neighbor or relative could only bring them at that time. therapists at srfcs often try their best to see these clients, even if it means juggling schedules and delaying other clients, with their permission, rather than sending clients home, recognizing that they have tried hard to keep the this article is protected by copyright. all rights reserved session and it may take a long time before they can come again or bring family members to the session. among the pathways to reduce inequality, flexibility and procedural accommodation between provider and client are the foundation for a trusting relationship and a working alliance. we believe it is possible to conduct effective, helpful and even fairly orderly treatment in the face of these procedural differences. to accept these differences, the therapist needs to trust the client's motivation and question their own ingrained and often misguided beliefs that events, such as late arrivals, are psychologically motivated or signal resistance to treatment or a lack of commitment to change. the practitioner's trust on the clients' interest in psychotherapy is essential (brown, lopez, & lopez ) , they tend to use them only for calling and texting, the latter depending on the age group. studies show that among contemporary immigrants, family and community attachments continue intensely at long distance via phone, text and video (falicov, ) , and recently with the application what'sapp. unfortunately, these media are not hipaa compliant and cannot be used for clinical purposes, while those that are, like zoom, are not easily available without an email address or internet connection. this article is protected by copyright. all rights reserved the use of virtual technology is not entirely new to working with immigrant families at the free clinic. for therapeutic purposes, we have connected family members geographically dispersed using videoconferencing platforms nationally and binationally. virtual connections for family therapy have accelerated and expanded locally during covid- , making more visible technologies that were tangential to our work, but not totally invisible. electronic technology limitations intensify the perils of inequality and require focused attention to reduce it. the presence of an it person at srfc, fully dedicated to exploring the feasibility of setting up video calls with clients, while training students, practitioners, interpreters and clients in it use is indispensable to providing services during this pandemic. interpreters are valuable aids to explore and walk-through the feasibility of remote sessions. unencumbered by language barriers, they help clients figure out the best means of communication, time and place in the household. other barriers to virtual or even phone use arise: lack of time for essential workers or mothers schooling children, work situations with no privacy, and any area with poor reception. living in very small quarters greatly encumbers the privacy needed to have a therapy hour for individuals, couples and even families. interruptions of children or other home occupants occur. the presence of others may limit sharing private thoughts or information that may need to remain confidential. for that reason, therapists check at the beginning of the phone or video session whether the individual, couple or family members have the privacy and comfort to start the session. other times, sessions need to be momentarily put on hold while the client answers the relentless questions of a nearby child. sometimes, more than one person needs access to the same phone in the household. a visually impaired patient who is very lonely sheltering at home asked us to call him for counseling appointments in the mornings because it is the time that he is alone, and has access to the only phone family members share. in the afternoon others usually need to use the phone, but also, he is less lonely then as his spirit is lifted by the company of their voices. despite these barriers, the clinic's team and our client families continue to be the creative problem solvers that embody the free clinic philosophy by stretching the limits of the possible. for instance, a client may realize that a grandson who is a high school student, or the adult daughter of a neighbor could lend a computer and help to set a video session for telehealth. sometimes there are unexpected treatment insights of using video by seeing the home situation, perhaps the crowding, the this article is protected by copyright. all rights reserved warmth of grandmother and grandchild, or the level of noise. indeed, the video session can become a virtual home visit. similarly, phone sessions also offer opportunities to get a glimpse of family relationships. during a phone session, when a client was tearfully sharing the pain of a recent loss, the client's daughter brought her tissues, offered a hug, and whispered in her ear "you are not alone". although the client quickly apologized for the "interruption", this event opened new avenues in the session. client and therapist explored the ways the former experienced the love and support of her daughters during this painful time. relying on promotoras as community links. it is often the case that clinic patients do not have experience with mental health professionals or are not clear of why they were referred. as therapists, we are aware that as we are strangers, why should people open their hearts and minds to us? a promotora is a long-time resident of the community who deeply understands its challenges. she has the role of being a lay health facilitator and advisor. she is the confidant to whom families tell what ails them, what is happening in their lives, how going to church helps them, how worried they are about the son's vulnerability to gangs, or about a girlfriend they do not approve of, or about a husband who drinks too much. in the srfcs, the promotoras often began as patients, became volunteers, and have become the clinic's most treasured employees. because of their wisdom and community know-how, they are also invited to the university as valued teachers of the students and the faculty. a promotora is the meaningful link between the mental health team and the community. she often functions for us as a "patient consultant". not only is she supportive of our services and knows us well, she is the intermediary that introduces us to a patient by saying in her own words: "this is celia, or alba, or sol. she is one of our "consejeras" ("counselors"). you can talk with her, you are in good hands with her". this powerful introduction de-stigmatizes psychotherapy services and it paves the way for the client to feel more open and trusting of us. the door has been opened to allow us to be embraced as part of the circle of safety and the community of concern at the clinic. promotoras are effective in latinx communities because they are acquainted with their community social networks, cultural values, health and mental health needs. they are also able to communicate in a language and idioms that are appropriate and accessible to the needs of the this article is protected by copyright. all rights reserved community ( rhodes et al., ) . they are often seen as role models of resilience in the face of adversity and as displaying behaviors to be emulated (waitzkin et al., ; edelblute et al., ) . during covid- , with the best of intentions, the therapists of our clinics offered to expedite the process by booking their own appointments to relieve the promotora of this task. they soon discovered that clients sometimes did not answer the phone or returned calls, and sometimes did not comply with the scheduled appointment. why? the therapist often blocked their phone number or simply their phone numbers were not recognized, and the client, protective of their families, did not answer. the trusted person whose name and number were recognized and answered immediately was the community promotora. therefore, during covid- , in the absence of face-to-face contacts, the services of the promotora to set up and remind clients of their telehealth appointments has become even more essential. offering psychotherapy in spanish is another door that eases the relationship with latinx clients. language concordance is ideal when clients are primarily monolingual immigrants. spanish as the language of birth creates a powerful connection that overrides nationality among latinos. our bilingual therapists are immigrants from argentina, mexico, colombia and costa rica, yet their different nationalities are overridden by the emotional impact of a shared language. it is interesting that studies of cultural adaptations of mainstream interventions indicate that language is the most important factor linked to effectiveness of the intervention, over and above ethnic matching (griner & smith, ) . during the pandemic, having bilingual/bicultural therapists facilitates the therapeutic connection in circumstances when the lack of face-to-face contact can initially make the sessions feel distant or impersonal. using interpreters. we make use of excellent interpreters when the mental health professional does not speak spanish. a sensitive and warm interpreter, who uses accessible language and perhaps even decreases the distance and possible stigma of mental health treatment by engaging the client more fully in conversation is a great asset. fortunately, training programs for providing accurate and clinically relevant translation and interpretation have been developing nationwide (deangelis, ) . during covid- , we have continued to use interpreters to translate psychiatric evaluation interviews with medical students and non-spanish speaking psychiatrists. interpreters may be needed too in psychotherapy appointments conducted by a mental health practitioner and a student this article is protected by copyright. all rights reserved over several sessions. consequently, there may be several professionals involved in a phone or a video appointment with clients. interpretation during video or phone psychotherapy sessions is more taxing for all parties, but specially for interpreters because the length of sessions and the scarcity of non-verbal cues are more difficult than during medical appointments. a support and empowering group. an asset to the mental health services in srfcs is a community patient group called el grupo de empoderamiento y ayuda humanitaria (the group of empowerment and humanitarian help). a promotora began to facilitate these weekly meetings with a student many years ago. the group met continuously on a weekly basis until it was interrupted by social distancing restrictions during the covid- pandemic. this group provides an important resource of emotional healing for our clients. in fact, participants have described the group as "lifesaving," as "part of extended family" they could rely on at times of need, and as a space that offers acceptance and healing (beck et al., a) . this is a drop-in collaborative group for clinic patients of any gender, that is also open to health and mental health providers, social workers, students, and clinic staff. hierarchies are minimized as we all share current personal issues and learn from each other. the topics of discussion are usually abstract, such as compassion, forgiveness or self-care, or a mother's day celebration or a newspaper article with a human story, all of which do not demand selfdisclosure, but nonetheless the conversation becomes therapeutic or psychoeducational. the topics stimulate reference to personal narratives of traumatic events, difficulties with parenting, or couple's issues. health stressors of chronic illness and recurrent pain, or concerns about gangs or neighborhood safety are also brought up. at other times, the group engages in expressive art and crafts projects that lend a sense of useful participation when the products are sold by the women as their fund-raising contribution to the clinic, or the participants are happy to bring home a collage, gift earrings or crafts to their family members. the group ends with all participants standing up in a circle, holding hands and praying, a ritual that attests to the emotional power of religious devotion. for us, as family therapists, one of the important lessons about family systems changes is hearing how many clients of the group report significant family transformations which they attribute to bringing home what they have learned from the group . there is openness in the group to hear various members bring up ideas or projects. for example, just prior to covid- the third author engaged the group in a narrative technique of drawing and discussing their tree of life (denborough, ) . when one of the group members became silenced by her own memories of trauma, the other group members came to her aid by sharing the many positive ways that she had touched their lives. over the years, the participation of members of the mental health team in this group has contributed to self-referrals from the patients, who either approach us or the promotora for requests for advice or counseling for themselves or their families. conversely, our therapists, appreciating the group's mental health benefits, have also referred their clients to the group. during covid- , this face-to-face group is not in session as few patients can partake in a video group experience. because the deprivation of this source of support and empowerment is significant, we are attempting to find creative ways to re-establish it. one idea is to mail envelopes of art supplies with instructions for projects and include a paid envelope with the clinic's address for return by those who would like their craft shared or displayed. as covid- prevention restrictions relax, we are considering meeting in a park, as it occurred sporadically before, respecting social distance. it is possible that the bonds of friendship and reliance on each other that this group has provided over time are a form of increased social capital that may continue during covid- either by phone talks, or favors, or simply by knowing that those relationships exist and could be called on. we surmise from the interactions with clients that we have had so far during covid- that it is important for therapists to first show concern about the impact of the pandemic on the total family and on each member before developing a shared agenda for the session. expressing empathy for the pile-up of overwhelming stressors in these trying times is an important ground for connection. engaging in a sense of presence and understanding for the universal uncertainties we all share, while supporting those specific cultural values and rituals that are possible to maintain are important parts of healing conversations. but we also are attentive to openings for conversations about the learnings that come from immigrants' long familiarity with living with the uncertainty of shifting realities. these this article is protected by copyright. all rights reserved in the current changed life scenario, we witness the intensification of old and new anxieties and fears as we saw earlier in the cases of the families of eugenia and lucia, with current presentations that require new supports and strategies. nevertheless, new healing family developments are also reported, such as grown sons or daughters, including some who have been estranged, who have become more involved and concerned for their parents' daily needs and endeavor to protect them from the dangers of contagion. in some cases, mothers who are domestics temporarily unable to be employed, are spending more time with their children with the benefit of getting to know them more. we have been amazed at the creativity of latinx communities that celebrate quinceañeras ( -year-old traditional lavish birthday celebrations) or engage in funeral processions with caravans of decorated cars parading with their headlights on. an example of new developments and reflections evolving from this changed situation can be learned from the following psychotherapy case. a case example. the client is rocío, a latina woman in her early 's with two children, ages and . rocío receives help and financial support from the father of her youngest son; however, she is the primary caretaker for her children. rocío has been a patient of the clinic for several years for various medical issues, and has received mental health treatment at different times with more than one clinician. her mother and other family members have been patients in the same clinic, a situation that happens with some frequency and facilitates engaging in family therapy. six months ago, rocío started coming to therapy again due to new relationship challenges with close family members for which she was already finding her preferred ways of being when the pandemic started. due to shelter in place orders, rocío was unable to work in her job at a school cafeteria, had to stay at home with her children, became worried about her financial situation, and had to engage in long distance education with her children. the children were also anxious with the change in their routine, not seeing their friends and the confinement of their small apartment and not being able to play in the park. the therapist started online therapy having some sessions with rocio alone and other sessions with rocio and her children. at a time of social distancing when the only way to receive education, health or mental health services is virtually, a person who does not have wifi connection, a computer or has computer literacy is at a disadvantage. as is the case for most low-income immigrant families, rocío did not have this article is protected by copyright. all rights reserved internet access and had to go through the process of getting it in her home and learning about technology she had never been exposed to. her cousin, who already had internet, helped her by calling the company and arranging the internet installation. she had to wait several days to get the service set up and had to redistribute her financial means to pay for it monthly. to receive mental health and health care services from our clinic, rocío worked with medical students to set up a zoom account on her phone and learn how to use it. the third author worked with rocío on understanding the effects of covid- on her and her children's lives. the therapist learned different ways in which the uncertainty was creating a sense of fear and affecting rocío's sleep. from a narrative perspective, the therapist engaged with the client in the practice of "double-listening" (yuen, , white , paying attention to the stories of struggle dealing with the practical and emotional impact of covid- , and simultaneously listening for her and her family's abilities to respond to these new challenges. in the conversation, alternative stories emerged, where rocío spoke about how being at home was also having positive effects on her relationship with her kids, which surprised her. this opened a conversation where rocío shared that she noticed she was being more patient with her children, even during this session as they interrupted. as we explored this in detail, i asked rocío how she would name this new way of being with her children and rocío called it "amabilidad en el hogar" (kindness in the home). through the conversation we learned how kindness was showing up in big and small ways and its effects on each member in the family. this led to a conversation about the family legacy of amabilidad en el hogar as rocío shared that this was a value she had learned from her mother who had passed away a few years ago and was rocio's strong emotional support. rocío shared stories about her own upbringing and how amabilidad or kindness was taught and modeled by the women in her family. at the end of the conversation the therapist wrote rocío a letter, which is a common narrative practice, to document her initiative to stay close to "amabilidad en el hogar durante los tiempos de covid- " (kindness in the home during the times of covid- ). below is a fragment of the letter (spanish original and english translation) where the therapist underlines the client's preferred ways of being with her children and her hopes to stay close to amabilidad en el hogar during hard times in her life. the therapist also conveys how she has been moved in her personal life to think and practice amabilidad and thanks the client for the invitation to this article is protected by copyright. all rights reserved do so, making transparent how much she learns from her client and is transformed by their conversations and relationship. in the next session, the therapist met with rocío and her children where rocio shared her new discoveries with her children and they shared with her how they see her as happier and funnier and how they are enjoying their time with her more. ….cuando usted es mamá desde la amabilidad se acerca al tipo de persona que quiere ser y ha sido por mucho tiempo y también es otra forma de seguir honrando y recordando a su mamá. también lo bien que se siente al tratarse con amabilidad es algo que usted quiere recordar en estos tiempos difíciles, cuando la vida quizás nos invita a olvidar la amabilidad y a ocuparnos de otras cosas. fue un gusto como siempre hablar con usted rocío y aprender de las formas que usted está pudiendo ser como mamá, me invitan a mí a querer quedarme cerca de este valor de la amabilidad también, como persona y como mamá. muchas gracias por la invitación! con cariño, english translation of the fragment of the letter: when you are a mom from a place of kindness, you get closer to the type of person you want to be and have been for a long time and it is another way to continue honoring and remembering your mom. also, how good it feels when kindness is around is something you want to remember during these difficult times, when life invites us to forget about kindness and take care of other things. it was a pleasure as always to talk to you rocío and learn about the ways you are able to be as a mother, they invite me to want to stay close to kindness as well, as a person and as a mother. thank you very much for the invitation!! fondly, the continuation of no-cost mental health services to underserved and uninsured latinx immigrant families as part of an academic student managed community project during the covid- this article is protected by copyright. all rights reserved pandemic illustrates attempts to overcome unprecedented new procedural and clinical practice challenges in the conceptions of structures, responses, time and space for services. our team's overall goal is to reach this underserved population. flexibilities of time and space, using procedures and protocols that alter the standard professional approaches used with over-resourced families, are necessary to overcome multiple contextual constraints. rather than describing underresourced families as "hard-to-reach", we believe that our adaptations are a form of justice and empowerment that have become even more compelling under covid- 's new constraints. relying on our learnings about providing services to under resourced families and communities in regular times, during the covid- pandemic we expand the limits of what appears possible in a variety of new ways. sessions are conducted via telehealth for clients that never had wifi or used computers before, accommodating to time slots of relative quiet or task-free time in the household, substituting the presence and support usually given by now socially distanced family and friends with empathy, caring words and offers of phone support given by therapists. reliance on community helpers or promotoras as intermediaries between professional staff and our client families to facilitate setting up and confirming appointments or legitimizing mental health care needs is even more necessary during covid- . deep commitment towards our clients as well as solidarity of purpose among the various members of the health and mental health team have become even more essential during these extraordinary circumstances. we consider concrete acts of care and solidarity, such as home delivery of donated healthy food and medications by the medical students at the clinic an important aid towards the mental well-being of under resourced families at this time of isolation and deprivation. no doubt, covid- has created excruciating challenges for already overburdened immigrant families, but in their resilient ways, they also demonstrate new, often creative and inspiring ways of responding, be it in terms of celebrations, funerals or new ways of parenting their children, appreciating love bonds or caring for their elders. expanding the possibilities of our own flexibility and solidarity as a professional team embodies what we are learning from families whose resilience has helped them face with courage and dignity untold adversities and injustices over generations. focusing on the strengths of families, we attempt to create space for both, honoring people's complex this article is protected by copyright. all rights reserved experiences and reactions in these anguished times and co-creating ways of responding together in this process, visualizing elements of hope and positive changes that may endure. as we are finishing writing this paper, the country is shaken by the continuous police brutality against black communities. the local and national protests have heightened our latinx immigrant communities' fear of police violence, immigration agents and government attacks towards their families. our clinic students and the entire clinic's team have shown an outpouring of support and solidarity and have directed their attention to the effects of these stressors on the well-being of our clients. to respond to these current realities, a decision has been made in the srfc project to strengthen the anti-racism university curriculum in integrative health and mental health care for underserved 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multi-method study of an intervention to address contextual sources of depression working with people who are suffering the consequences of multiple trauma: a narrative perspective health and the community pathways beyond despair: re-authoring lives of young people through narrative therapy accepted article key: cord- -altqn l authors: fernández-díaz, elena; iglesias-sánchez, patricia p.; jambrino-maldonado, carmen title: exploring who communication during the covid pandemic through the who website based on w c guidelines: accessible for all? date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: altqn l health crisis situations generate greater attention and dependence on reliable and truthful information from citizens, especially from those organisations that represent authority on the subject, such as the world health organization (who). in times of global pandemics such as covid- , the who message “health for all” takes on great communicative importance, especially from the point of view of the prevention of the disease and recommendations for action. therefore, any communication must be understandable and accessible by all types of people, regardless of their technology, language, culture or disability (physical or mental), according to the world wide web consortium (w c), taking on special relevance for public health content. this study analysed whether the who is accessible in its digital version for all groups of citizens according to the widely accepted standards in the field of the internet. the conclusion reached was that not all the information is accessible in accordance with the web content accessibility guidelines . , which implies that there are groups that are, to some extent, left out, especially affecting the elderly. this study can contribute to the development of proposals and suggest ways in which to improve the accessibility of health content to groups especially vulnerable in this pandemic. the use of the internet has increased in the last decade, as approximately % of the world's population now uses this medium. in , there are more than . billion people using the internet [ ]. therefore, not only has the capacity of access to the internet increased but more and more users have access to internet content, also as a source of information. in the face of a pandemic such as covid- , access to reliable information by citizens is crucial as a means of preventing the disease and enabling citizens to take action in certain everyday situations, as demonstrated in a study by the european parliament's european science-media hub [ ] . the world health organization (who) website is one of the main sources of information for the public, providing daily updates and interactive maps showing the evolution of the pandemic and offering credibility and security of information [ ] . in addition to the who, other international sources of information stand out, such as the european centre for disease prevention and control and the european commission's coronavirus and coronavirus response page, as well as the european medicines agency, among others. as has happened in the world with the zika and ebola pandemics, the internet is not only a source of communication for prevention and action in the face of health crises but also becomes a channel for misinformation [ , ] , making the need to share accurate and accessible information even more significant. the objective reasons for carrying out this study are mainly based on analysing the web accessibility of the world health organization (who) during the covid- pandemic. thus, the objective will be to determine whether the content offered to inform about the disease is prepared so that any person can access it, regardless of their technology (hardware, software, or network infrastructure), language, culture, or disability, whether physical or mental, as determined by the world wide web consortium (w c). this institution is an international community that aims to ensure that anyone can access the content offered by a website, promoting the social value it provides for all citizens [ ] . a lack of equity of access to health information can generate a digital divide [ , ] and affect the ability to deal the disease [ ] . consequently, it represents a social determinant of health. in addition, the elderly are an important group of citizens who benefit from web accessibility, since their skills are weaker as a result of age [ ] . bearing in mind that older people are considered one of the main groups at risk in this pandemic, it is especially important that they are the ones who have the most access to the content offered by information sources such as the who [ ] . from the point of view of web accessibility, it should be emphasised how few studies have been carried out on international and official organisations with important social responsibilities such as the who, as they are more oriented towards the education sector such as universities and local corporations such as town councils [ ] [ ] [ ] [ ] [ ] . most of these studies do not focus on recent recommendations but only on some that have been detected in the area of education [ , ] ; likewise, studies have shown that citizens' dependence on the media is more intense in crisis situations [ ] . however, traditional media and the internet play different roles for people in these public health crises, and the internet's dependence on individuals is greater than that of traditional media [ ] . therefore, one of the major contributions of this research is based on the originality of the analysis of universally accessible public health risk communication in times of global pandemic. likewise, the consideration that access to information is a health determinant is also relevant. this research is structured in the following blocks. after the introduction, the theoretical framework shows the who as the main health agency and information reference in the covid- pandemic. the methodology of the research is of an exploratory type, contemplating an analysis of the who' page using the wave tool and a manual review of each of the criteria of the content accessibility guidelines. the results obtained reflect the level of accessibility of the who according to international standards. the practical implications of this study highlight the need to raise awareness among health organisations such as the who about the importance of accessibility to their digital content in times of health crisis with the social objective of universal health information accessibility. the main contribution is the analysis of accessibility, taking particular account of elderly people, as one of the most vulnerable groups in this pandemic, and consequently, it provides practical proposals for addressing this challenge for health institutions. the who is an international organisation founded in , and since then, the world has undergone great political and economic changes, not only from the point of view of health [ ] . its headquarters are located in geneva, with offices in different countries and six regional offices [ ] . any country that is a member of the united nations can become a member of this organisation [ ] . in order to become a member, countries must agree to its constitution, which currently includes member states [ ] . among the different activities addressed by this organisation, one of the main objectives is to provide universal health coverage by supporting integrated health services for citizens. they offer prevention, surveillance and a response to possible risks that may threaten citizen security, for example, in pandemics such as covid- [ ] . this underlines the importance of this organisation as the importance of this organisation as the main source of information on this disease, which has become a pandemic caused by the coronavirus, the outbreak of which began in december in wuhan, china, and has affected the whole world [ ] . the who acts as an agency that promotes accessibility in all its fields, including digital, and provides recommendations on its website [ ] . for its part, the spanish association of scientific communication (aecc) [ ] highlights the who as one of the main sources of consultation for the citizens of affected countries. in the united states, . % of the population seeks health information on the internet [ ] . in order to offer as much information as possible on covid- , the who has created specific pages on prevention, symptoms and action protocols and even a solidarity page for donations to help research and detect the spread of the virus. these donations also go to unicef partners to support their work in communities that are the most vulnerable, such as children [ ] . it is important to note that an outbreak such as covid- causes important social consequences, affecting social distance in the most affected countries and generating more anxiety [ ] . all of the above have resulted in an increase in google searches for the keywords "world health organization" and "coronavirus world health organization" worldwide, which began to grow in early march, as can be seen in figure . this search result confirms that the who has a social responsibility to provide quality content and information that is accessible to all types of people, since as the network evolves, different challenges are being addressed, resulting in a continuous need for relationships and trust [ ] . moreover, it is a way of ensuring equity, eliminating disparities and improving the health of all groups [ ] . it is important to highlight the responsibility that the management of pandemics entails for the who, since depending on the type, it involves a problem of uncertainty when the end of the pandemic is declared, as occurred in the case of influenza a (h n ) in [ ] . lamb-white [ ] refers to the who's commitment to improving communicable diseases through the international health regulations (ihr) to improve public health, and this would therefore help countries to strengthen their capacity to achieve this. figure shows the significant increase in visits, unique visitors and pages per visit in the last months for the who website. moreover, it is surprising that the average duration of visits has also increased, so it can be said that the who website has been and is a reference for consultation on public health on a global level, especially in times of pandemics this search result confirms that the who has a social responsibility to provide quality content and information that is accessible to all types of people, since as the network evolves, different challenges are being addressed, resulting in a continuous need for relationships and trust [ ] . moreover, it is a way of ensuring equity, eliminating disparities and improving the health of all groups [ ] . it is important to highlight the responsibility that the management of pandemics entails for the who, since depending on the type, it involves a problem of uncertainty when the end of the pandemic is declared, as occurred in the case of influenza a (h n ) in [ ] . lamb-white [ ] refers to the who's commitment to improving communicable diseases through the international health regulations (ihr) to improve public health, and this would therefore help countries to strengthen their capacity to achieve this. figure shows the significant increase in visits, unique visitors and pages per visit in the last months for the who website. moreover, it is surprising that the average duration of visits has also increased, so it can be said that the who website has been and is a reference for consultation on public health on a global level, especially in times of pandemics such as covid- , as can be seen in the data. in addition, the semrush tool (semrush.com), comparing the who's traffic data with those of the website of the european centre for disease prevention and control (the second most popular website after the who's according to the european parliament's european science-media hub [ ] ), shows that the who website visits increased from the end of february to april. prevention and control (the second most popular website after the who's according to the european parliament's european science-media hub [ ] ), shows that the who website visits increased from the end of february to april. figure shows that the who pages related to the covid- pandemic were the most visited in the last months according to a study by the european science-media hub of the european parliament [ ] . specifically, this tool has shown that in countries such as spain, the keyword "coronavirus" has increased organic traffic on the who website, accounting for more than % of organic web traffic, as can be seen in figure , in addition to terms such as covid- being incorporated in the top positions, showing that citizens have real public health concerns through the search for these keywords that are incorporated into the ranking of new searches related to the who. apart from the organic traffic referenced above, it should be noted that the who is making great communication efforts to reach all citizens through the paid searches of search engines such as google, specifically through ads in different languages, depending on the search keyword. people with disabilities have many difficulties in becoming independent as a result of the lack of commitment of the different public policies in force. a report by the spanish committee of representatives of people with disabilities (cermi) states: "universal accessibility is the great failure of public policies in our country" [ ] (p. ). this causes people with disabilities to figure shows that the who pages related to the covid- pandemic were the most visited in the last months according to a study by the european science-media hub of the european parliament [ ] . specifically, this tool has shown that in countries such as spain, the keyword "coronavirus" has increased organic traffic on the who website, accounting for more than % of organic web traffic, as can be seen in figure , in addition to terms such as covid- being incorporated in the top positions, showing that citizens have real public health concerns through the search for these keywords that are incorporated into the ranking of new searches related to the who. [ ] ), shows that the who website visits increased from the end of february to april. figure shows that the who pages related to the covid- pandemic were the most visited in the last months according to a study by the european science-media hub of the european parliament [ ] . specifically, this tool has shown that in countries such as spain, the keyword "coronavirus" has increased organic traffic on the who website, accounting for more than % of organic web traffic, as can be seen in figure , in addition to terms such as covid- being incorporated in the top positions, showing that citizens have real public health concerns through the search for these keywords that are incorporated into the ranking of new searches related to the who. apart from the organic traffic referenced above, it should be noted that the who is making great communication efforts to reach all citizens through the paid searches of search engines such as google, specifically through ads in different languages, depending on the search keyword. people with disabilities have many difficulties in becoming independent as a result of the lack of commitment of the different public policies in force. a report by the spanish committee of representatives of people with disabilities (cermi) states: "universal accessibility is the great failure of public policies in our country" [ ] (p. ). this causes people with disabilities to apart from the organic traffic referenced above, it should be noted that the who is making great communication efforts to reach all citizens through the paid searches of search engines such as google, specifically through ads in different languages, depending on the search keyword. people with disabilities have many difficulties in becoming independent as a result of the lack of commitment of the different public policies in force. a report by the spanish committee of representatives of people with disabilities (cermi) states: "universal accessibility is the great failure of public policies in our country" [ ] (p. ). this causes people with disabilities to encounter physical and technological barriers in their daily lives. consequently, it suggests that institutions with competences could address this matter and pay attention to accessibility to minimise the digital divide [ ] , achieve health equity, and allow all groups to better face the disease [ ] . according to webaim, the internet is an opportunity for people who have some kind of disability, since it allows them to access information through diverse content quickly and by means of different devices and software, for example, screen readers for people with vision problems. however, these opportunities that the world wide web (www) should offer through websites are not sufficiently optimised and adapted to the different needs of citizens according to their disability [ ] . according to who data, the aging of the population and the increase in chronic diseases are one of the main reasons for the increase in disability rates, which is about % for the world's population [ ] . in fact, age is a physical and social determinant directly correlated with health [ ] . in times of crisis, communication through written messages is remembered more than those transmitted through other formats, so it must be not only accessible but also accurate so that it is understood by the majority of the population [ ] . studies have confirmed that because of the speed with which these types of diseases such as covid- are transmitted, citizens and different countries need to increase their vigilance and prepare themselves through preventive responses [ ] . communication is particularly important in this regard, as is access to equal opportunities for all. however, if information tends to be complex and ambiguous in terms of the interpretations that citizens may make, situations of panic and anxiety may arise [ ] . exceptional crisis situations such as the covid- pandemic generate greater attention or dependence on information, especially reliable and accurate information. in addition to this maxim, which can be contrasted with previous literature, internet penetration makes it easy to access information and increases the level of information that each person has, which is why the following research questions are posed: rq : does the who make itself accessible to all groups of citizens according to accepted standards in the field of the internet? rq : what aspects of web content analysis can be improved, and which audiences are affected? this research analyses the web accessibility of the who website based on the web content accessibility guidelines . in an exploratory way. the analysis was carried out during the covid- pandemic in march-may , coinciding with one of the world's most popular periods for citizens to search for information (figure ) . the methodology was combined using a web accessibility evaluation tool and manual analysis carried out by an evaluator [ , ] . the tool used for accessibility evaluation was the wave tool [ ] , developed by the webaim organisation. the website accessibility conformity assessment methodology (wcag-em) was used, which is considered in the web content accessibility guidelines . but is applicable to wcag . [ ] . as for the variables analysed, they belong to the web content accessibility guidelines (wcag), which explain how to make content more accessible to developers and other professional profiles related to web accessibility authoring and evaluation tools, including mobile accessibility [ ] . it should be recalled in historical retrospect that wcag . was a recommendation in may . it consists of a total of guidelines and priority , and checkpoints depending on the level of compliance [ ] . wcag . was recommended in december . unlike the previous ones, it is composed of guidelines and four principles-perceptible, operable, understandable and robust-with criteria for success [ ] . however, the latest guidelines recommended in june are wcag . , with a total of guidelines and compliance criteria; in this case, the w c has included new criteria, maintaining the four principles mentioned above [ ] . the web content accessibility guidelines present different conformance levels-a, aa and aaa [ ] [ ] [ ] [ ] . in the case of wcag . , the levels depend on satisfying the priority levels to ; for example, it is determined that level a is met when all the priority checkpoints are satisfied [ ] . however, in wcag . and . , the levels do not refer to priorities to ; for example, it is determined that level a is met when all the level a compliance criteria are satisfied [ , ] . in order to carry out a more in-depth analysis, six representative pages from the entire website were analysed (table ). the sample was selected by taking representative pages that allow the checking of each of the analysed criteria; for example, a page with forms must be checked to determine the compliance of the labels in the fields, or a page with tables must be checked to ensure that the conent is in an accessible form; additionally, videos must be checked for their audiovisual accessibility. the methodology (wcag-em) suggested by w c [ ] recommends selecting representative urls for each criterion: standard page: a second-level reference page of the website that describes the structure of the website. page with tables: a page that shows content laid out using tables. page with forms: registration forms, application forms, information forms, etc. result of a search: the information necessary for the location of contents is extracted and checked by means of a keyword search; in this case of analysis, the word "covid- " is used as an example. . page containing video: to analyse compliance with the guidelines in the case of videos. once the representative urls of the rest of the who website were selected, as shown in table , the compliance with each of the variables to wcag . was analysed. these are shown in tables and , divided into levels of compliance a or double a respectively: after analysing each of the criteria, the results obtained were collected with the data analysis tool (table ); the variables of the wcag . analysed are shown in the upper part of the table, facilitating manual data collection and the checking of compliance. the first step was to check if the success criterion could be applied to the analysed url and how many times it was applied to (a). the second step was to check whether the success criterion was approved (b) or not (m). the symbols have the following meanings (table ) : p: pages analysed for each service a: pages to which the criterion applies b: pages that are correct according to the criterion m: pages that breach the criterion as can be seen in table , the total number of pages analysed (tp) was calculated, the correct (tb) and incorrect (tm) pages were counted, and as a result, a percentage was obtained of the correct who pages, obtaining an average that represents the percentage of web accessibility compliance of each page analysed (%b). the formula is as follows: (%b) = (tb × /tp). source: author's elaboration based on the infoaccessibility observatory of discapnet [ ] for the manual assessment phase, table details the tools that enabled the level of compliance to be checked according to the wcag . guidelines on those points that required more in-depth review, apart from the wave tool, in the first phase. the analysis shows that the who website is % compliant regarding web accessibility based on the pages analysed; however, at the double-a level, the figure is slightly less than a % level of compliance. from the point of view of the four principles (appendix a, table a ) that underpin the wcag . -perceptible, operable, understandable and robust-it can be seen that the principle that is most complied with on the who website is understandable at both levels, with % and . % compliance, respectively. therefore, the who's digital health information is readable and understandable based on this principle [ ] . however, robust is the worst performer at both the a and aa levels, at % and %, respectively. it is precisely this principle that focuses on adapting the content to user applications and providing technical aids [ ] . the perceivable principle, directly related to the alternative text of the images, although it does not present outstanding values at level a with respect to the rest, is the second principle that best meets the double-a conformity criteria, with regard to the size and contrast of the text, benefiting those with vision problems derived from both age and sensory disabilities [ ] . finally, it should be noted that the operable principle shows significant differences upon comparison at both levels, worsening at the double-a level, and therefore, navigation aspects have to be improved [ ] . generally, the principles that are most closely adhered to are found in level a, so it is concluded that those in level aa are the ones that need to be improved for each compliance criterion analysed in the wcag . . with respect to the total number of errors detected by the wave tool and later analysed manually, it is worth highlighting in figure that the home page is the one with the most errors, followed by the form page and the page with tables. generally, the principles that are most closely adhered to are found in level a, so it is concluded that those in level aa are the ones that need to be improved for each compliance criterion analysed in the wcag . . with respect to the total number of errors detected by the wave tool and later analysed manually, it is worth highlighting in figure that the home page is the one with the most errors, followed by the form page and the page with tables. if one analyses it from the point of view of contrast errors, one will find that the page with the highest number of contrast errors is the table page, followed by the type page and the page with video ( figures and ). contrast errors are based on the fact that the visual presentation of the text and the images of the text must be sufficiently differentiated so that users with some type of visual disability can differentiate the text when reading, especially in the case of older age groups [ ] . if one analyses it from the point of view of contrast errors, one will find that the page with the highest number of contrast errors is the table page, followed by the type page and the page with video ( figures and ). contrast errors are based on the fact that the visual presentation of the text and the images of the text must be sufficiently differentiated so that users with some type of visual disability can differentiate the text when reading, especially in the case of older age groups [ ] . if one analyses it from the point of view of contrast errors, one will find that the page with the highest number of contrast errors is the table page, followed by the type page and the page with video ( figures and ). contrast errors are based on the fact that the visual presentation of the text and the images of the text must be sufficiently differentiated so that users with some type of visual disability can differentiate the text when reading, especially in the case of older age groups [ ] . regarding the non-text content errors detected, it can be seen that they also happen on all pages, especially form pages (figure ) , so people who need a screen reader will be especially affected because there is no alternative text for the images. regarding the non-text content errors detected, it can be seen that they also happen on all pages, especially form pages (figure ) , so people who need a screen reader will be especially affected because there is no alternative text for the images. from the point of view of the type of errors detected, figures and show each of them in detail. it is worth noting from the comparison between the level a and double a errors that they coincide in both cases, and there are a total of seven success criteria with % error rates for the pages analysed. of the total errors detected, the most significant are those referring to non-text content within level a, as they are directly related to the alternative text of the image by means of the alt tag, preventing screen readers from accessing the content by means of images for visually impaired citizens and, in the case of level aa, the visible focus, since if the user cannot clearly see where the keyboard tab is when browsing the page, it is difficult for them to conduct proper and understandable navigation through the content. regarding the non-text content errors detected, it can be seen that they also happen on all pages, especially form pages (figure ) , so people who need a screen reader will be especially affected because there is no alternative text for the images. from the point of view of the type of errors detected, figures and show each of them in detail. it is worth noting from the comparison between the level a and double a errors that they coincide in both cases, and there are a total of seven success criteria with % error rates for the pages analysed. of the total errors detected, the most significant are those referring to non-text content within level a, as they are directly related to the alternative text of the image by means of the alt tag, preventing screen readers from accessing the content by means of images for visually it is therefore determined that each of these errors detected requires a complete review that, in turn, contemplates alternative solutions based on guidelines established by the w c to comply with the requirements set by the wcag . . it is therefore determined that each of these errors detected requires a complete review that, in turn, contemplates alternative solutions based on guidelines established by the w c to comply with the requirements set by the wcag . . as a main point of discussion, it should be noted that the who [ ] states on its website that one of its objectives as an international organisation is based on improving universal accessibility to health services, both in internet media and in physical media; however, its website does not show any kind of statement on accessibility with which they currently comply. it should be emphasised that the home page is one of the pages with the most errors; taking into account the fact that it is usually the first page that a user consults before proceeding to browse the rest of the web, it should be a principal target for improvement. in addition, the who recommends adopting digital media for health education [ ] , so it could be considered a special committer to digital media. as is seen in previous research work, assuming this responsibility is necessary to ensure health equity and to reduce the digital divide, which can affect the ability to face the disease for some population groups [ , , ] . considering the studies that have been carried out on citizens' dependence on the media in times of public health crisis, most are based on analysing the differences between dependence on traditional media and that on the internet [ , ] , but they do not focus on analysing the information offered from the point of view of the accessibility of a particular agency and the social responsibility they have towards citizens facing a pandemic and seeking information. therefore, this study provides originality based on a specific case of accessibility in a health agency such as the who and provides points of improvement to make the content universal, at a crucial time of global pandemic, such as that presented by covid- . furthermore, this article reinforces the conclusions reached by other studies in which it is highlighted that the population seeks information on public health mainly through the internet [ , ] . from a technical point of view, more associated with web accessibility studies, it is worth mentioning that due to the recent approval of the wcag . , most studies have focused on the previous guidelines, so there is a shortage of studies based on the new guidelines, among which [ , ] , focusing on the education sector, stand out. based on the results obtained, it is considered that the who is not accessible to all groups of citizens according to the web content accessibility guidelines . , being less than % accessible at one of the levels analysed. it is concluded that many aspects need to be improved in order to make it fully accessible. one of the main online messages transmitted by the who [ ] is "health for all", and therefore, this research calls for "web accessibility for all" as the main aim and contribution to ensure that citizens have access to accurate, understandable and direct information; in short, there should be universal accessibility. it is also one of the overarching goals of the healthy people initiative that specifically pays attention to achieving health equity and improving the health of all groups [ ] . hence, the concept of accessibility in times of crisis such as the covid- pandemic is especially relevant, regarding the social value of the web. among the most notable errors are those concentrated largely within the principles understandable and perceivable, which shows that they are essential variables of communication with citizens, since they are directly related to content that is easy to understand in the first case and offer text alternatives for non-text content in the second case, especially for people with vision problems who use screen readers and even groups of elderly citizens who have vision problems as a result of physical aging. it is therefore determined that one of the aspects that most needs to be improved in terms of accessibility parameters is directly related to these two principles. with regard to the limitations, it should be mentioned that the analysis could be completed with a heuristic study that would include manual checking as well as checking over time. on the other hand, comparison with other key information sources and the incorporation of who web users or those involved in this health crisis could offer a more complete vision of the phenomenon of web accessibility during a pandemic as well as the evaluation of the websites of other institutions. with regard to future lines of research, since wcag . must also be implemented in the mobile applications of public administrations, the analysis of the mobile applications of international organisations with social implications such as the who is proposed. it has also been considered as a future line of research to carry out user tests, a practice recommended by the w c [ ] . there are also different systems for groups with physical disabilities, where information can be collected from sources other than websites-for example, with bots-so it is proposed for these lines of research be considered in the future to make this research work more substantial. the practical implications of this study are mainly based on the fact that international organisations with competence in the matter should review the structure and texts as well as everything related to the content in order to approach this challenge in an equitable way and provide the interested public with the same options of access to information. this study allows us to consider the accesibility of the who web resources with a special focus on elderly groups. the diagnosis performed will help health organisations to make decisions and to pay attention to critical points. the absence of text in images (non-text content) and errors in the html code (parsing) should be stressed. this study acts as a first attempt to analyse accessibility for the most representative health institution, the who. this is the main social value that this research aims to convey, that the main sources of information-international organisations, whose responsibility for health is crucial in times of global pandemics such as the one we are experiencing-can be given solutions that provide greater visibility to the information. global digital overview european parliament's european science-media hub. esmh selection: sources of information about coronavirus twitter, and misinformation: a dangerous combination? zika 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organisation world health organisation comité español de representantes de personas con discapacidad. derechos humanos y discapacidad an introduction to web accessibility, web standards, and web standards makers passing crisis and emergency risk communications: the effects of communication channel, information type, and repetition coronavirus disease (covid- ): a literature review public health communication in time of crisis: readability of on-line covid- information a comparative test of web accessibility evaluation methods applying heuristics to perform a rigorous accessibility inspection in a commercial context evaluating web accessibility of educational websites website accessibility conformance evaluation methodology. wcag-em web content accessibility guidelines (wcag) overview web content accessibility guidelines . web content accessibility guidelines (wcag) . accesibilidad web. wcag . de forma sencilla world wide web consortium (w c) world wide web consortium (w c) accesibilidad web en los portales de ayuntamientos de capitales de provincia who guidance for digital health: what it means for researchers involving users in evaluating web accessibility this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the authors declare no conflict of interest. key: cord- -mxehiuq authors: soofi, moslem; najafi, farid; karami-matin, behzad title: using insights from behavioral economics to mitigate the spread of covid- date: - - journal: appl health econ health policy doi: . /s - - - sha: doc_id: cord_uid: mxehiuq the outbreak of coronavirus disease (covid- ) has become a public health emergency of international concern. the number of covid-infected individuals and related deaths continues to rise rapidly. encouraging people to adopt and sustain preventive behaviors is a central focus of public health policies that seek to mitigate the spread of covid- . public health policy needs improved methods to encourage people to adhere to covid- -preventive behaviors. in this paper, we introduce a number of insights from behavioral economics that help explain why people may behave irrationally during the covid- pandemic. in particular, present bias, status quo bias, framing effect, optimism bias, affect heuristic, and herding behavior are discussed. we hope this paper will shed light on how insights from behavioral economics can enrich public health policies and interventions in the fight against covid- . the outbreak of coronavirus disease (covid- ) has become a public health emergency of international concern [ ] . the number of covid-infected individuals and related deaths continues to rise rapidly. covid- is a serious threat to global health and the world economy and has caused widespread concern around the world. in the absence of approved treatments for and vaccines against covid- , preventive strategies and hygiene behaviors such as social distancing and stay-at-home policies, avoiding touching the face, and repeated hand washing are effective options in the fight against covid- [ , ] . during this pandemic, encouraging people to adopt and sustain preventive behaviors is a central focus of public health policies that seek to mitigate the spread of covid- . behavioral economics has recently received a great deal of attention in public policy making [ ] . this field of economics uses insights from the fields of psychology, neuroscience, and cognitive sciences to explain how people's behaviors deviate from the rational choice theory and when and why people's short-term decisions sometimes undermine their long-term interests. the focus of this field is on better predicting and understanding people's behaviors and choices to help formulate more effective public policies [ , ] . it identifies biases in the decision-making process and uses them as entry points for interventions to address particular behaviors. behavioral economics acknowledges that people do not have infinite rationality and willpower, so they are not the rational decision makers assumed in the standard economic theory of utility maximization [ , ] . in addition, they have limited cognitive and computational abilities, and their decisions are not based on a complete analysis of all available information [ ] . these limitations lead people to apply the rules of thumb or heuristics (i.e., mental shortcuts) to make their decisions rather than conducting cost-benefit analyses when making a decision. the heuristics are generally useful but can lead to systematic mistakes (i.e., biases) in decision making that, in turn, result in suboptimal and harmful behaviors [ , ] . behavioral economics has shed new light on a range of risky and preventive health behaviors [ ] . it also has considerable potential for providing a valuable perspective to better understand and explain covid- -related behaviors. while multiple biases are identified in the field of behavioral economics, in this paper we focus on six that tend to be particularly relevant to covid- -related behaviors: present bias, status quo bias, framing effect, optimism bias, affect heuristic, and herding behavior. it may provide useful insights into public health policies designed to reduce the spread of covid- and may be helpful in developing and implementing interventions. in the context of intertemporal choices, the costs and benefits of our choices occur at different points in time, that is, many daily choices are a trade-off between immediate outcomes (i.e., costs and benefit) and expected future outcomes [ ] . present bias or hyperbolic discounting is the nonlinear and nonconstant tendency of many individuals to prefer a smaller sooner pay-off over a larger future pay-off [ ] [ ] [ ] . present bias may lead to time-inconsistent preferences. an individual makes a plan for tomorrow, but once tomorrow comes they may experience a preference reversal and revise their plan. present bias has been shown to be a significant predictor of a wide variety of health behaviors [ ] . many health behaviors involve a trade-off between immediate and future outcomes. for example, smoking has both current benefits (temporary stress relief) and future costs (increased risk of lung cancer) [ ] . in the case of covid- , not adhering to stay-at-home policies involves a trade-off between the pleasure of going to the mall or restaurant now (current benefit) and the increased risk of contracting covid- in the future (uncertain future cost). uncertain future cost means that not every excursion outside the house would result in covid- infection. thus, myopic individuals (i.e., those with present bias), who put a greater emphasis on the here and now, are less likely to adhere to covid- -preventive behaviors, including staying at home and hand washing. present bias is an explanation for why people do not behave in their own best interests and why they have difficulty adhering to preventive health behaviors such as social distancing, even when they wish to adhere [ ] . although present bias may lead to suboptimal behavioral choices, it can be used to help people adhere to covid- -preventive behaviors [ ] . for example, reducing the current costs of adherence to social distancing may help people overcome their present bias, as even small costs could outweigh any perceived future benefits of adherence. increasing the current benefit of adherence to social distancing, such as offering small and frequent payments now, can be useful in encouraging people to adhere to covid- -preventive behaviors. such interventions involving low-cost rewards have been used as ways to increase current benefits of adherence to antiretroviral medication [ ] , smoking cessation [ ] , and weight loss [ ] , and they have been shown to be effective in changing behaviors. to reduce covid- transmission, in the short term, providing free internet access at home, temporary suspension of loan repayments (e.g., loans provided by the government to support unemployed and uninsured people to start small businesses), and providing benefit packages for vulnerable groups should be considered in stay-at-home policies to encourage people to adhere to the policy and to increase its success rate. status quo bias is a disproportionate preference for the current status of options and an unwillingness to change them [ , ] . one reason for this is that people interpret the potential disadvantages of changing the status quo as greater than the potential benefits. this bias can be turned to the advantage of encouraging health-enhancing behaviors through the use of "nudges". the concept of "nudge" was introduced in behavioral economics to persuade individuals to behave rationally and make better choices. thaler and sunstein [ ] defined a nudge as "any aspect of the choice architecture that influences individuals' decision making in a predictable way without forbidding any options or changing economic incentives." they argued that, by improving and altering the environment in which individuals make decisions-what they call the "choice architecture"-, individuals can be influenced to make smarter choices. choice architecture can be used to build an environment in which it is easier to make optimal health choices and more difficult to select suboptimal ones. the default option is a nudge with a powerful impact on directing the behaviors of people in ways that meet their long-term interests [ ] . one of the most notable examples of the default option is organ donation. countries with an opt-out system (consent to donate is assumed, and the default option is to donate organs) have a considerably higher rate of organ donation than countries with an opt-in system (default option is not to donate organs) [ ] . positive effects from the default option have also been reported for vaccination uptake [ ] and the rate of enrollment into a diabetes management program [ ] . covid- -prevention policies can also nudge people to engage in hygiene practices such as repeated hand washing by arranging defaults in the environment where they make covid- -related choices. for example, soaps with toys embedded inside improved hand washing behavior in children [ ] . this example is a choice architecture (i.e., nudge) that may nudge children to wash their hands more frequently, so could be used to increase hand washing during this covid- outbreak. a field experiment study in india found that the installation of low-cost soap dispensers in homes improved hand washing in peri-urban and rural households [ ] . framing effect refers to the fact that individuals' choices often depend on the way the choices are described, or framed, and that these choices are often affected by whether the possible outcomes are framed in terms of the gains or the losses [ ] . this concept is closely associated with loss aversion, which implies that the disutility caused by a given amount of loss is about twice the utility of gaining the same amount. for example, the statements "the odds of survival after month of surgery are %" and "the odds of mortality within month of surgery are %" elicit different reactions. both statements offer the same information, but many individuals react differently to the risk of surgery when presented as a % chance of survival versus a % chance of death [ ] . the framing effect has application for directing individuals toward health-promoting decisions and has been examined in a wide variety of health behaviors [ ] . a health message can be framed to emphasize the benefits (i.e., gainframed message) of performing a specific behavior or to emphasize the disadvantages (i.e., loss-framed message) of not engaging in that behavior [ ] . studies have shown that loss-framed messages are often more effective for disease-detection behaviors such as uptake of cancer screening, whereas gain-framed messages are often more effective for promoting preventive behaviors. a meta-analysis of studies found that health messages framed as gains or benefits were significantly more likely to increase preventive behaviors than those framed as losses [ ] . it offers a helpful perspective for framing health messages regarding covid- prevention. it seems that health messages intended to encourage people to engage in covid- -preventive behaviors (e.g., social distancing) should be framed in terms of gains, such as "if you wash your hands properly/ follow social distancing policy/adhere to the stay-at-home policy, you will increase the chances of yourself and your family having a long, healthy life." people display unrealistic optimism about their vulnerability to a wide set of negative outcomes [ ] and often see themselves as being at less-than-average risk of negative outcomes. optimism bias is people's tendency to estimate the probability of positive future outcomes as greater than average and that of negative future outcomes as less than average [ , ] . this may lead people to unwittingly take extra risks with their own health and more than they would if they were aware of the objective risk of health-related behavior [ ] . this can help explain a wide range of risktaking behaviors, including health-related decisions. for example, one study revealed that smokers underestimated their risk of developing lung cancer compared with that of other smokers and even non-smokers [ ] . another study found that people with a subjective risk lower than their objective risk were more likely to support the belief that there is no risk of lung cancer if you just smoke for a few years and to believe that a large number of patients with lung cancer are cured. they were even less likely to decide to stop smoking [ ] . people realize the risk of getting covid- from suboptimal behaviors such as not washing hands or not adhering to social distancing but are likely to believe that they are less likely than other people or their peers to get covid- , even if their peers adhere to preventive practices. providing peer comparison feedback or communicating risks accurately can be helpful for addressing optimism and overconfidence bias. in addition, priming an outcome by presenting what has happened to individuals or populations that are considered peers may persuade people to adhere to preventive behaviors [ ] . for example, adolescents may become more engaged in covid- -prevention programs if they are aware that an adolescent celebrity contracted covid- . a possible explanation for this may be that the covid- infection of an adolescent celebrity tends to increase the perception of individuals regarding their personal risk of getting covid- . affect heuristic is a person's tendency to judge risks and benefits based on their affect, that is, different affects can produce different risk and benefit perceptions [ ] . it has been shown that individuals' affect acts as a form of information that they refer to when deciding whether to engage in particular health behaviors [ , ] . in particular, when people feel positive about a behavior, they judge its risks as low and benefits as high; when they feel negative about a behavior, they judge its risks as high and benefits as low [ ] . evidence has shown that, while risk and benefit appear to be often uncorrelated or even positively correlated across harmful behaviors in the real-world context (i.e., high-risk activity appears to be highly gainful), they are often negatively correlated in individuals' judgments and decisions (i.e., high risk is associated with low profit and vice versa) [ , ] . a study found that test harm information about prostatespecific antigen screening for prostate cancer and magnetic resonance imaging reduced perceived test benefits [ ] . a study of how affect influences individuals' processing of messages about risks and benefits of using autonomous artificial intelligence technology to screen for skin cancer found that integral artificial intelligence affect impacted on individuals' perception of risk and benefits based on messages provided, which then influenced the probability of using artificial intelligence technology for health [ ] . if perceptions of risk and benefit are directed by affect, the provision of benefits information will switch people's judgment of risk and vice versa [ ] . therefore, the messages that people receive about a certain behavior become an important source of information that influences their health decisions [ ] . this heuristic suggests that policy maker's efforts to create negative feelings toward not adhering to covid- -preventive behaviors can increase the perceived risks associated with not adhering. for example, if an individual is told that not adhering to social distancing policy might cause them to contract covid- , this is predicted to cause negative feelings toward not adhering, which should, in turn, reduce the perceived benefits of not adhering to social distancing. in addition, "don't miss the opportunity to be together at home" may be helpful for encouraging people to adhere to stay-athome policies. a controlled trial in india showed that a scalable village-level intervention based on emotional drivers of behavior was more successful at increasing hand washing than was providing information [ ] . social norms and the behavior of peers such as friends, family members, and colleagues affect behaviors. herding behavior occurs when people consider a certain behavior to be good or bad based on the behavior of other people and mimic their observed behaviors [ ] . this characteristic of human behavior is well-established in a number of fields, particularly economics and finance [ ] . one implication of this behavior is that if a policy aims to encourage people to make a health decision, then it needs to inform individuals about the behavior of other people and their peers [ ] . in a real-world experiment conducted on tax compliance in minnesota, one of the interventions informed people that more than % of minnesotans had paid their taxes; this had a significant effect on tax compliance compared with other interventions [ , ] . to nudge people to adhere to social distancing policy, interventions should draw attention to what other people are doing [ ] . for example, telling people that "the majority of the people in your neighboring city or province are following the social distancing/stay-at-home policy" may increase adherence to social distancing policy. we have discussed insights from behavioral economics that shed light on how to help people engage in covid- -preventive behaviors. this paper can improve our understanding of the decision-making biases that can be applied as entry points in public health policies and interventions for the prevention of covid- . they may assist policy makers in identifying novel interventions to improve decision making and behaviors related to the prevention of covid- . we provided some policy suggestions that may be useful in the fight against covid- , summarized as follows: reduce the current costs or increase the current benefits of adherence to social distancing/stay-at-home policies, arrange defaults in environments where people make covid- -related choices (i.e., choice architecture), design gain-framed messages for covid- -preventive behaviors, prime contamination with covid- by presenting examples pertinent to a specific population, create negative feelings toward not adhering to covid- -preventive behavior, and draw individual's attention to what other individuals are doing about covid- -related decisions. while many health-related behaviors have been shown to be associated with the six decision biases discussed, the degree to which they impact covid- -preventive behaviors has not yet been empirically investigated. future work should examine strategies such as gain-framed messages, incentives in terms of small frequent rewards, and default options or nudges to improve interventions designed to prevent not only covid- but also other communicable diseases. state ment-on-the-secon d-meeti ng-of-the-inter natio nal-healt h-regul ation s-( )-emerg ency-commi ttee-regar ding-the-outbr eak-of-novel emerging coronaviruses: genome structure, replication, and pathogenesis isolation, quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus ( -ncov) outbreak the role of behavioral economics in evidence-based policymaking nudge: improving decisions about health, wealth and happiness behavioral economics: past, present, and future from cashews to nudges: the evolution of behavioral economics judgment under uncertainty: heuristics and biases some current dimensions of the behavioral economics of health-related behavior change descriptive validity of alternative intertemporal models for health outcomes: an axiomatic test golden eggs and hyperbolic discounting can behavioural economics make us healthier? 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decision under risk behavioral economics guidelines with applications for health interventions. washington: inter-american development bank judgment under uncertainty: heuristics and biases. cambridge: cambridge university press health message framing effects on attitudes, intentions, and behavior: a meta-analytic review unrealistic optimism about future life events unrealistic optimism about susceptibility to health problems: conclusions from a community-wide sample intertemporal choices for health smokers' unrealistic optimism about their risk unrealistic optimism in smokers: implications for smoking myth endorsement and selfprotective motivation applying behavioral economics to public health policy: illustrative examples and promising directions the affect heuristic in judgments of risks and benefits handbook of theories of social psychology. thousand oaks: sage the functions of affect in health communications and in the construction of health preferences risk perception and affect the role of the affect heuristic and cancer anxiety in responding to negative information about medical tests does integral affect influence intentions to use artificial intelligence for skin cancer screening? a test of the affect heuristic effect of a behaviour-change intervention on handwashing with soap in india (superamma): a cluster-randomised trial predictably irrational herding in humans the minnesota income tax compliance experiment: replication of the social norms experiment. available at ssrn key: cord- - mk c authors: storr, julie; twyman, anthony; zingg, walter; damani, nizam; kilpatrick, claire; reilly, jacqui; price, lesley; egger, matthias; grayson, m. lindsay; kelley, edward; allegranzi, benedetta title: core components for effective infection prevention and control programmes: new who evidence-based recommendations date: - - journal: antimicrob resist infect control doi: . /s - - - sha: doc_id: cord_uid: mk c health care-associated infections (hai) are a major public health problem with a significant impact on morbidity, mortality and quality of life. they represent also an important economic burden to health systems worldwide. however, a large proportion of hai are preventable through effective infection prevention and control (ipc) measures. improvements in ipc at the national and facility level are critical for the successful containment of antimicrobial resistance and the prevention of hai, including outbreaks of highly transmissible diseases through high quality care within the context of universal health coverage. given the limited availability of ipc evidence-based guidance and standards, the world health organization (who) decided to prioritize the development of global recommendations on the core components of effective ipc programmes both at the national and acute health care facility level, based on systematic literature reviews and expert consensus. the aim of the guideline development process was to identify the evidence and evaluate its quality, consider patient values and preferences, resource implications, and the feasibility and acceptability of the recommendations. as a result, recommendations and three good practice statements are presented here, including a summary of the supporting evidence, and form the substance of a new who ipc guideline. electronic supplementary material: the online version of this article (doi: . /s - - - ) contains supplementary material, which is available to authorized users. infection prevention and control (ipc) is a universally relevant component of all health systems and affects the health and safety of both people who use health services and those who provide them. health care-associated infections (hai) are one of the most common adverse events in care delivery and both the endemic burden and epidemics are a major public health problem. in , the world health organization (who) [ ] reported that on average % of patients in developed and % in low-and middle-income countries (lmics) suffer from at least one hai at any given time, with attributable mortality estimated at % [ ] . the burden of hai is significantly higher in lmics and affects especially high-risk populations, such as patients admitted to neonatal and intensive care units where the frequency of hai is two to times higher compared to high-income countries, notably for device-associated infections [ ] . hai has a significant and largely avoidable economic impact at both the patient and population levels, including out-of-pocket costs to patients and costs incurred through lost productivity due to morbidity and mortality. although the evidence related to the economic burden of hai is limited, particularly in lmics, available data from the usa and europe suggest costs estimated at several billions. according to the us centers for disease control and prevention, the overall annual direct medical costs of hai to hospitals in the usa alone ranges from us$ . to billion [ ] , while the annual economic impact in europe is as high as € billion [ ] . although significant progress has been made to reduce hai in many parts of the world, a number of emerging events have underlined the need to support countries in the development and strengthening of ipc with the objective to achieve resilient health systems, both at the national and facility levels. in recent years, global public health emergencies of international concern, such as the middle east respiratory syndrome coronavirus and the ebola virus disease outbreaks, revealed gaps in ipc measures applied by the countries concerned. furthermore, the current review of the international health regulations and the global action plan to combat antimicrobial resistance (amr) [ ] [ ] [ ] [ ] [ ] called for strengthening ipc across nations. this will also contribute to achieve strategic goal of the who framework on integrated people-centred health services and the united nations sustainable development goals -in particular, those related to universal access to water and sanitation and hygiene (wash), quality health service delivery in the context of universal health coverage, and the reduction of neonatal and maternal mortality. in consideration of these factors, who decided to prioritize the development of evidence-based recommendations on the essential elements ("core components") of ipc programmes at the national and facility level. with the exception of a set of ipc core components previously identified by experts during a who meeting [ ] , there is a major gap in international evidence-based recommendations as to what should constitute the key elements of effective ipc programmes at the national and facility level. a first step was made by a project initiated by the european centre for disease prevention and control, which identified key components for hospital organization, management and structure for the prevention of hai based on evidence and expert consensus [ ] . we present here the new who core components for ipc improvement to be implemented in acute health care facilities and at the national level (www.who.int/ gpsc/ipc-components/en/), with a brief description of the background scientific evidence. this guidance builds on the initial momentum of the who ipc core components interim document published in [ ] . the recommendations were elaborated according to the best available scientific evidence and expert consensus with the ultimate aim to ensure a high quality of health service delivery for every person accessing health care, as well as to protect the health workforce delivering those services. the intended audience on a national level is primarily policy-makers responsible for establishing and monitoring national ipc programmes and delivering amr national action plans. the recommendations are also relevant to those in charge of health facility accreditation/regulation, health care quality improvement, public health, disease control, wash, occupational health, and antimicrobial stewardship programmes. at the facility level, the main target audience is facility-level administrators, ipc and wash leaders and teams, safety and quality leads and managers, and regulatory bodies. allied organizations will also have an interest in the core components, including academic institutions, national ipc professional bodies, nongovernmental organizations involved in ipc, and civil society groups. the who guidelines were developed according to the requirements described in the who handbook for guideline development [ ] . the first source of evidence was the review published by the "systematic review and evidence-based guidance on organization of hospital infection control programmes" (sight) group [ ] , which included publications from to . this review was updated to include literature published up to november . an additional systematic review with the same objectives was performed, but with a focus on the national level. key research questions were identified and formulated according to the pico (population/participants, intervention, comparator and outcomes) process. in addition, an inventory of national and regional ipc action plans and strategic documents was undertaken as part of the background to these guidelines. we searched medline (via ebsco); the excerpta medica database (embase) (via ovid); the cumulative index to nursing and allied health literature (cinahl); the cochrane central register of controlled trials (cen-tral); the outbreak database; and the who institutional repository for information sharing. the time limit was between january and november for the update of the sight review, and between january and december for the national level review. studies in english, french, portuguese and spanish were eligible. a comprehensive list of search terms was used in both reviews, including medical subject headings (mesh) (additional files and ). in the earlier review done by the sight group, the quality of the evidence was assessed using the "integrated quality criteria for review of multiple study designs" (icroms) scoring system [ ] . the sight review update and the review focusing on the national level used the risk of bias criteria developed for the cochrane effective practice and organization of care (epoc) reviews [ ] . due to different methodologies and outcome measures, it was not possible to perform a meta-analysis for any of the reviews. the recommendations were developed by a panel of international experts based on the available evidence and its quality, the balance between benefits and harms, cost and resource implications, acceptability and feasibility, and user and patient values and preferences. members of the panel were key international ipc experts and country delegates. geographical and gender balance were ensured, including representation from various professional groups, such as physicians, nurses, clinical microbiologists, ipc and infectious disease specialists, epidemiologists, researchers, and patient representatives. the strength of recommendations was rated as either "strong" (the panel was confident that the benefits of the intervention outweighed the risks) or "conditional" (the panel considered that the benefits of the intervention probably outweighed the risks). in the absence of methodologically sound, direct evidence on the effectiveness of interventions, good practice statements were developed for ipc components that were judged essential by consensus [ ] . the recommendations and their individual strength, the good practice statements, and the key remarks for implementation made by the panel are presented in table . ipc programmes are one component of safe, highquality health service delivery. a who global survey published in revealed major weaknesses in national ipc capacity [ ] . among the respondent countries, only had a national ipc programme ( %) in place and even fewer reported a programme in all tertiary hospitals ( / ; %). in addition, our inventory of ipc national strategies or action plans showed that while the vast majority of documents ( %) across all regions addressed ipc programme structure and goals, only % specified the importance of having qualified and dedicated staff to support the programme, and only % highlighted the need for an adequate budget and wash infrastructure. the panel recommends that an ipc programme with a dedicated, trained team should be in place in each acute health care facility for the purpose of preventing hai and combating amr through ipc good practices. (strong recommendation, very low quality of evidence) evaluation of the evidence from two studies (one controlled before-after study [ ] and one interrupted time series [ ] ) showed that ipc programmes including dedicated, trained professionals are effective in reducing hai in acute care facilities. despite the limited published evidence and its very low quality, the panel strongly recommended that an ipc programme should be in place in all acute health care facilities. this decision was based on the large effect of hai reduction reported in the two studies and on the panel's conviction that the existence of an ipc programme is the necessary premise for any ipc action. the panel supports the establishment of stand-alone, active national ipc programmes with clearly defined objectives, functions and activities for the purpose of preventing hai and combating amr through ipc good practices. national ipc programmes should be linked to other relevant national programmes and professional organizations. several studies concerning the implementation of nationwide multimodal programmes aimed at reducing specific types of infections were retrieved, e.g. catheterassociated bloodstream infection. however, no evidence was available to evaluate the effectiveness of a more comprehensive national ipc programme and, therefore to formulate a recommendation. despite this, experts and country representatives brought very clear examples where an active and sustained national ipc programme with effectively implemented plans has led to improvement of national hai rates and/or the reduction of infections due to multidrug-resistant organisms. in addition, the international health regulations ( ) [ ] and the who global action plan on amr ( ) [ ] support national level action on ipc as a central part of health systems' capacity building and preparedness. this includes the development of national plans for preventing hai, the development or strengthening of national policies and standards of practice regarding ipc activities in health care facilities, and the associated monitoring of the implementation of and adherence to these national policies and standards. therefore, the panel strongly affirmed that each country should have a stand-alone, active national ipc programme to prevent hai, to combat amr through ipc good practices, and thus to ultimately achieve safe, high-quality health service delivery. the availability of technical guidelines consistent with the available evidence is essential to provide a robust • it is critical for a functioning ipc programme to have dedicated, trained professionals in every acute care facility. a minimum ratio of one full-time or equivalent infection preventionist (nurse or doctor) per beds should be available. however, there was a strong opinion that a higher ratio should be considered, for example, one infection preventionist per beds, due to increasing patient acuity and complexity, as well as the multiple roles and responsibilities of the modern preventionist. • good quality microbiological laboratory support is a very critical factor an effective ipc programme. strong, very low quality b. active, stand-alone, national ipc programmes with clearly defined objectives, functions and activities should be established for the purpose of preventing hai and combating amr through ipc good practices. national ipc programmes should be linked with other relevant national programmes and professional organizations. • the organization of national ipc programmes must be established with clear objectives, functions, appointed infection preventionists and a defined scope of responsibilities. minimum objectives should include: ▪ goals to be achieved for endemic and epidemic infections ▪ development of recommendations for ipc processes and practices that are known to be effective in preventing hai and the spread of amr • the ihr ( ) and the who global action plan on amr ( ) support national level action on ipc as a central part of health systems' capacity building and preparedness. this includes the development of national plans for preventing hai, the development or strengthening of national policies and standards of practice regarding ipc activities in health facilities, and the associated monitoring of the implementation of and adherence to these national policies and standards. • the organization of the programme should include (but not be limited to) at least the following components: ▪ appointed technical team of trained infection preventionists, including medical and nursing professionals ▪ the technical teams should have formal ipc training and allocated time according to tasks ▪ the team should have the authority to make decisions and to influence field implementation ▪ the team should have a protected and dedicated budget according to planned ipc activity and support by national authorities and leaders • the linkages between the national ipc programme and other related programmes are key and should be established and maintained. • an official multidisciplinary group, committee or an equivalent structure should be established to interact with the ipc technical team. good practice statement table summary of ipc core components and key remarks (continued) the panel recommends that evidence-based guidelines should be developed and implemented for the purpose of reducing hai and amr. the education and training of relevant health care workers on the guideline recommendations and the monitoring of adherence with guideline recommendations should be undertaken to achieve successful implementation. health care facility • appropriate ipc expertise is necessary to write or adapt and adopt a guideline both at the national and health care facility level. guidelines should be evidence-based and reference international or national standards. adaptation to local conditions should be considered for the most effective uptake and implementation. • monitoring adherence to guideline implementation is essential. national level • developing relevant evidence-based national ipc guidelines and related implementation strategies is one of the key functions of the national ipc programme. • the national ipc programme should also ensure that the necessary infrastructures and supplies to enable guideline implementation are in place. • the national ipc programme should support and mandate health care workers' education and training focused on the guideline recommendations. strong, very low quality . ipc education and training a. the panel recommends that ipc education should be in place for all health care workers by utilizing team-and task-based strategies that are participatory and include bedside and simulation training to reduce the risk of hai and amr. • ipc education and training should be a part of an overall health facility education strategy, including new employee orientation and the provision of continuous educational opportunities for existing staff, regardless of level and position (for example, including also senior administrative and housekeeping staff). • three categories of human resources were identified as targets for ipc training and requiring different strategies and training contents: ipc specialists, all health care workers involved in service delivery and patient care, and other personnel that support health service delivery (administrative and managerial staff, auxiliary service staff, cleaners, etc.). • periodic evaluations of both the effectiveness of training programmes and assessment of staff knowledge should be undertaken on a routine basis. strong, moderate quality b. the national ipc programme should support the education and training of the health workforce as one of its core functions. • the ipc national team plays a key role to support and make ipc training happen at the facility level. • to support the development and maintenance of a skilled, knowledgeable health workforce, national pregraduate and postgraduate ipc curricula should be developed in collaboration with local academic institutions. • in the curricula development process, it is advisable to refer to international curricula and networks for specialized ipc programmes and to adapt these documents and approaches to national needs and local available resources. • the national ipc programme should provide guidance and recommendations for in-service training to be rolled out at the facility level according to detailed ipc core competencies for health care workers and covering all professional categories listed in core component a. good practice statement . surveillance a. the panel recommends that facility-based hai surveillance should be performed to guide ipc interventions and detect outbreaks, including amr surveillance with timely feedback of results to health care workers and stakeholders and through national networks. • surveillance of hai is critical to inform and guide ipc strategies. • health care facility surveillance should be based on national recommendations and standard definitions and customized to the strong, very low quality ▪ describing the status of infections associated with health care (that is, incidence and/or prevalence, type, aetiology and, ideally, data on severity and the attributable burden of disease). ▪ identification of the most relevant amr patterns. ▪ identification of high risk populations, procedures and exposures. ▪ existence and functioning of wash infrastructures, such as a water supply, toilets and health care waste disposal. ▪ early detection of clusters and outbreaks (that is, early warning system). ▪ evaluation of the impact of interventions. • quality microbiology and laboratory capacity is essential to enable reliable hai surveillance. • the responsibility for planning and conducting surveillance and analysing, interpreting and disseminating the collected data remains usually with the ipc committee and the ipc team. • methods for detecting infections should be active. different surveillance strategies could include the use of prevalence or incidence studies. • hospital-based infection surveillance systems should be linked to integrated public health infection surveillance systems. • surveillance reports should be disseminated in a timely manner to those at the managerial or administration level (decision-makers) and the unit/ward level (frontline health care workers). • a system for surveillance data quality assessment is of the utmost importance. b. the panel recommends that national hai surveillance programmes and networks that include mechanisms for timely data feedback and with the potential to be used for benchmarking purposes should be established to reduce hai and amr. • national hai surveillance systems feed in to general public health capacity building and the strengthening of essential public health functions. national surveillance programmes are also crucial for the early detection of some outbreaks in which cases are described by the identification of the pathogen concerned or a distinct amr pattern. furthermore, national microbiological data about hai aetiology and resistance patterns also provide information relevant for policies on the use of antimicrobials and other amr-related strategies and interventions. • establishing a national hai surveillance programme requires full support and engagement by governments and other respective authorities and the allocation of human and financial resources. • national surveillance should have clear objectives, a standardized set of case definitions, methods for detecting infections (numerators) and the exposed population (denominators), a process for the analysis of data and reports and a method for evaluating the quality of the data. • clear regular reporting lines of hai surveillance data from the local facility to the national level should be established. • international guidelines on hai definitions are important, but it is the adaptation at country level that is critical for implementation. • microbiology and laboratory capacity and quality are critical for national and hospital-based hai and amr surveillance. strong, very low quality table summary of ipc core components and key remarks standardized definitions and laboratory methods should be adopted. • good quality microbiological support provided by at least one national reference laboratory is a critical factor for an effective national ipc surveillance programme. • a national training programme for performing surveillance should be established to ensure the appropriate and consistent application of national surveillance guidelines and corresponding implementation toolkits. • surveillance data is needed to guide the development and implementation of effective control interventions. . multimodal strategies a. the panel recommends that ipc activities using multimodal strategies should be implemented to improve practices and reduce hai and amr. • successful multimodal interventions should be associated with an overall organizational culture change as effective ipc can be a reflector of quality care, a positive organizational culture and an enhanced patient safety climate. • successful multimodal strategies include the involvement of champions or role models in several cases • implementation of multimodal strategies within health care institutions needs to be linked with national quality aims and initiatives, including health care quality improvement initiatives or health facility accreditation bodies. strong, low quality b. the panel recommends that national ipc programmes should coordinate and facilitate the implementation of ipc activities through multimodal strategies on a nationwide or subnational level. • the national approach to coordinating and supporting local (health facility level) multimodal interventions should be within the mandate of the national ipc programme and be considered within the context of other quality improvement programmes or health facility accreditation bodies. • ministry of health support and the necessary resources, including policies, regulations and tools, are essential for effective central coordination. this recommendation is to support facility level improvement. • successful multimodal interventions should be associated with overall cross-organizational culture change as effective ipc can be a reflector of quality care, a positive organizational culture and an enhanced patient safety climate. • strong consideration should be given to country adaptation of implementation strategies reported in the literature, as well as to feedback of results to key stakeholders and education and training to all relevant persons involved in the implementation of the multimodal approach. strong, low quality . monitoring/audit of ipc practices and feedback a. the panel recommends that regular monitoring/audit and timely feedback of health care practices according to ipc standards should be performed to prevent and control hai and amr at the health care facility level. feedback should be provided to all audited persons and relevant staff. • the main purpose of auditing/monitoring practices and other indicators and feedback is to achieve behaviour change or other process modification to improve the quality of care and practice with the goal of reducing the risk of hai and amr spread. monitoring and feedback are also aimed at engaging stakeholders, creating partnerships and developing working groups and networks. • sharing the audit results and providing feedback not only with those being audited (individual change), but also with hospital management and senior administration (organizational change) are critical steps. ipc teams and committees (or quality of care strong, low quality committees) should also be included as ipc care practices are quality markers for these programmes. • ipc programmes should be periodically evaluated to assess the extent to which the objectives are met, the goals accomplished, whether the activities are being performed according to requirements and to identify aspects that may need improvement identified via standardized audits. important information that may be used for this purpose includes the results of the assessment of compliance with ipc practices, other process indicators (for example, training activities), dedicated time by the ipc team and resource allocation. b. the panel recommends that a national ipc monitoring and evaluation programme should be established to assess the extent to which standards are being met and activities are being performed according to the programme's goals and objectives. hand hygiene monitoring with feedback should be considered as a key performance indicator at the national level. • regular monitoring and evaluation provides a systematic method to document the progress and impact of national programmes in terms of defined indicators, for example, tracking hand hygiene improvement as a key indicator, including hand hygiene compliance monitoring. • national level monitoring and evaluation should have in place mechanisms that: ▪ provide regular reports on the state of the national goals (outcomes and processes) and strategies. ▪ regularly monitor and evaluate the wash services, ipc activities and structure of the health care facilities through audits or other officially recognized means. ▪ promote the evaluation of the performance of local ipc programmes in a non-punitive institutional culture. strong, moderate quality . workload, staffing and bed occupancy (acute health care facility only) the panel recommends that the following elements should be adhered to in order to reduce the risk of hai and the spread of amr: ( ) bed occupancy should not exceed the standard capacity of the facility; ( ) health care worker staffing levels should be adequately assigned according to patient workload. • standards for bed occupancy should be one patient per bed with adequate spacing between patient beds and that this should not be exceeded. • intended capacity may vary from original designs and across facilities and countries. for these reasons, it was proposed that ward design regarding bed capacity should be adhered to and in accordance with standards. in exceptional circumstances where bed capacity is exceeded, hospital management should act to ensure appropriate staffing levels that meet patient demand and an adequate distance between beds. these principles apply to all units and departments with inpatient beds, including emergency departments. • the who workload indicators of staffing need method provides health managers with a systematic way to determine how many health workers of a particular type are required to cope with the workload of a given health facility and decision-making (http:// www.who.int/hrh/resources/wisn_user_manual/en/). • overcrowding was recognized as being a public health issue that can lead to disease transmission. • ensuring an adequate hygienic environment is the responsibility of senior facility managers and local authorities. however, the central government and national ipc and wash programmes also play an good practice statement na not applicable framework to support the performance of good practices. importantly, the existence of guidelines alone is not sufficient to ensure their adoption and implementation science principles and findings clearly indicate that local adaptation is a prerequisite for successful guideline adoption. the who inventory identified that on average, % of national ipc documents addressed the development, dissemination, and implementation of technical guidelines and % emphasized the importance of local adaptation. over % of national documents addressed the need for the training of all staff in ipc measures. the panel recommends that evidence-based guidelines should be developed and implemented for the purpose of reducing hai and amr. the education and training of relevant health care workers on the guideline recommendations and the monitoring of adherence with guideline recommendations should be undertaken to achieve successful implementation. evaluation of the evidence from six studies (three noncontrolled before-after studies [ ] [ ] [ ] , one noncontrolled interrupted time series [ ] and two qualitative studies [ , ] ) showed that guidelines on the most important ipc good practices and procedures are effective to reduce hai when implemented in combination with health care workers' education and training. three reports were from an upper-middle-income country (argentina) [ ] [ ] [ ] and the remaining ones were from the usa [ , , ] . the overall quality of evidence was very low. however, the panel unanimously decided to strongly recommend the development and implementation of ipc guidelines, supported by health care workers' education and training and monitoring of adherence to guidelines. ipc education spans all domains of health service delivery and is relevant to all health care workers, ranging from frontline workers to administrative management. our inventory of ipc national strategies or action plans revealed that the vast majority of documents ( %) across all regions highlighted the importance of building basic ipc knowledge among all health care workers. however, only % also addressed specialized training of ipc professionals, and only % specified that specialized staff responsible for ipc are needed at the facility level. the panel recommends that ipc education should be in place for all health care workers by utilizing team-and task-based strategies that are participatory and include bedside and simulation training to reduce the risk of hai and amr. (strong recommendation, moderate quality of evidence) evaluation of the evidence from studies (five interrupted case series [ ] [ ] [ ] [ ] [ ] , five qualitative [ , [ ] [ ] [ ] [ ] , two controlled before-after [ , ] , two non-controlled before-after [ , ] , and one mixed methods [ ] ) showed that ipc education that involves frontline health care workers in a practical, hands-on approach and incorporates individual experiences is associated with decreased hai and increased hand hygiene compliance. twelve studies were from high-income countries [ - , - , - ] , two from one upper-middleincome country [ , ] , and one from a lmic [ ] . the overall quality of evidence was moderate. as a result, the panel decided to strongly recommend that ipc education and training should be in place for all health care workers using a team-and task-oriented approach. the national ipc programme should support the education and training of the health workforce as one of its core functions. several studies related to the implementation of nationwide multimodal programmes were retrieved (see core component ). these included a strong health care worker education and training component with the aim to reduce specific types of infections, e.g. catheterassociated bloodstream infections. in addition, health care worker training was found to be an essential component for effective guideline implementation (see core component ). however, there was no specific evidence on the effectiveness of national curricula or ipc education and training per se. our inventory highlighted that training for all health care workers was a strong feature of existing national ipc documents. this ranged from % of documents in the who european region to % in the african region. therefore, the panel considered that it was important to develop a good practice statement to recommend that ipc national programmes should support education and training of the health workforce as one of its core functions to prevent hais and amr and to achieve safe, high-quality health service delivery. it is widely acknowledged that surveillance systems allow the evaluation of the local burden of hai and amr and contribute to the early detection of hai and new patterns of amr, including the identification of clusters and outbreaks. ipc activities should respond to the actual needs of the health care facility, based on the local hai situation and compliance with ipc practices. for these reasons, surveillance systems for hai, including amr patterns, are an essential component of both national and facility ipc programmes. national ipc surveillance systems also feed in to general public health capacity building and the strengthening of essential public health functions. however, a recent who survey on the global situational analysis of amr, showed that many regions reported poor laboratory capacity, infrastructure, and data management as impediments to surveillance [ ] . in our inventory of ipc national strategy or action plan documents, most ( %) contained guidance relating to the establishment of priorities for surveillance, despite some regional variations. of note, only % of documents addressed the need for standardized definitions with clear gaps in recommending surveillance in the context of outbreak response and detection. the panel recommends that facility-based hai surveillance should be performed to guide ipc interventions and detect outbreaks, including amr surveillance, with timely feedback of results to health care workers and stakeholders and through national networks. evaluation of the evidence from studies ( noncontrolled before-after [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , one interrupted time series [ ] and one qualitative study [ ] ) showed that a hospital-based surveillance system, especially when linked to national surveillance networks, is associated with a decrease in overall hai, central line-associated bloodstream infections, ventilator-associated pneumonia, surgical site infection, and catheter-related urinary tract infections. the studies also emphasized that the timely feedback of results is influential in the implementation of effective ipc actions. active surveillance with public feedback as part of a methicillin-resistant staphylococcus aureus (mrsa) care bundle strategy was associated with a decrease in mrsa infections in a hospital in singapore [ ] . one qualitative study explored the importance of surveillance and feedback to stakeholders and found that they were very influential in the implementation of an ipc programme targeting ventilator-associated pneumonia [ ] . all studies were from high-income countries. the overall quality of evidence was very low given the study designs and the high risk of bias. however, given the importance of surveillance not only for reducing hai and the early detection of outbreaks, but also for awareness-raising about the importance of hai and amr, the panel decided to strongly recommend that hai surveillance with timely feedback of results should be performed in acute health care facilities to guide ipc interventions. the panel recommends that national hai surveillance programmes and networks that include mechanisms for timely data feedback and with the potential to be used for benchmarking purposes should be established to reduce hai and amr. (strong recommendation, very low quality of evidence) evaluation of the evidence from one trial (randomized controlled study [ ] ) shows that when hai surveillance programmes introduce mechanisms for timely feedback and national benchmarking in the context of a subnational network, there is a significant reduction in hai rates. although they did not meet the epoc quality criteria, a number of additional articles clearly showed the benefits of national surveillance and feedback to reduce hais. given the importance of surveillance per se to reduce hais and to guide effective ipc interventions, the panel decided to strongly recommend that national hai surveillance programmes including mechanisms for timely feedback should be established to reduce hai and amr and be used for benchmarking purposes, despite the limited evidence available. however, the panel recognized that their implementation is resourceintensive (both financial and human resources), particularly in lmics. over the past decade, studies in ipc and implementation research have demonstrated that best practice interventions are most effective when applying several interventions/approaches integrated in a multimodal strategy. at its core, a multimodal implementation strategy supports the translation of evidence and guideline recommendations into practice within health care with a view to changing health care worker behaviour. a multimodal strategy consists of several elements or components (three or more -usually five) implemented in an integrated manner. it includes tools, such as bundles and checklists, developed by multidisciplinary teams that take into account local conditions. the five most common components include: (i) system change (improving equipment availability and infrastructure at the point of care) to facilitate best practice; (ii) education and training of health care workers and key stakeholders (e.g. managers and hospital administrators); (iii) monitoring of practices, processes, and outcomes and providing timely feedback; (iv) improved communication (e.g. reminders in the workplace or videos); and (v) culture change by fostering a safety climate [ ] . it is widely accepted that focusing on one approach (component) only will not achieve or sustain behaviour change. a national approach in support of the implementation of multimodal ipc improvement efforts is recognized as having key benefits compared to localized efforts alone. for the purposes of this work, "national" was considered to embrace both national and/or subnational (e.g. state-wide) activity. the panel recommends implementing ipc activities using multimodal strategies to improve practices and reduce hai and amr. (strong recommendation, low quality of evidence) evaluation of the evidence from studies ( noncontrolled before-after [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , eight noncontrolled cohort trials [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , ten interrupted time series [ , , , , , [ ] [ ] [ ] [ ] [ ] , four qualitative [ , [ ] [ ] [ ] , three randomized controlled trials [ ] [ ] [ ] , two controlled before-after [ , ] , two mixed methods [ , ] , one non-controlled interrupted time series [ ] and one stepped wedge [ ] ) showed that implementing ipc activities at facility level using multimodal strategies is effective to improve ipc practices and reduce hai. this was particularly relevant for hand hygiene compliance, central line-associated bloodstream infection, ventilatorassociated pneumonia and infections caused by mrsa and clostridium difficile. multimodal strategies included the following components: system change; education; awareness raising; bundle-based strategies; promotion of a patient safety culture, including leadership engagement, identification of champions and positive reinforcement strategies; and increased accountability via monitoring and timely feedback. forty studies were from high-income countries [ , , , , , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] , two from one upper-middle-income country [ , ] , and one from a lower-middle-income country [ ] . the overall quality of evidence was low given the medium-to high-risk of bias across studies and the different study designs. based on this evidence, the panel strongly recommended that the implementation of ipc activities should be done using multimodal strategies in an effort to improve care practices, reduce hai, and combat amr. the panel recommends that national ipc programmes should coordinate and facilitate the implementation of ipc activities through multimodal strategies on a nationwide or sub-national level. (strong recommendation, low quality of evidence) evaluation of the evidence from studies (seven interrupted time series [ , [ ] [ ] [ ] [ ] [ ] [ ] , four controlled before-after [ , [ ] [ ] [ ] , two randomized controlled trials [ , ] and one non-randomized controlled trials [ ] ) shows that the national roll-out of multimodal strategies is associated with reductions in central line-associated bloodstream infection, mrsa infections, and increased hand hygiene compliance. by contrast, no significant difference in surgical site infections rates was observed. the elements within the national multimodal strategies varied, but they were evaluated as a collective whole. the number of elements ranged from two to eight. the most frequently cited elements were the implementation of a care bundle with the provision of training and campaign materials to support the implementation [ , , , , , [ ] [ ] [ ] [ ] [ ] . all studies were from high-income countries. the overall quality of evidence was low given the medium-to high-risk of bias across studies. given the relatively good number of national studies identified and the conviction that multimodal strategies are an innovative and effective approach not only to reduce hais, but also to achieve broader patient safety improvement, the panel decided to strongly recommend that ipc activities should be implemented under the coordination and facilitation of the national ipc programme using multimodal strategies in an effort to improve care practices and reduce hai and combat amr. core component : monitoring/audit of ipc practices and feedback ipc interventions require the consistent practice of preventive procedures, such as hand hygiene, respiratory hygiene, use of surgical antimicrobial prophylaxis, the aseptic manipulation of invasive devices, and many others. the appropriateness with which these procedures are performed depends on the individual health care worker's behaviour and the availability of the appropriate resources and infrastructures. to identify deviations from requirements and to improve performance and compliance, the frequent assessment of working practices is necessary by using standardized auditing, indicator monitoring, and feedback. the monitoring and evaluation of national programmes is important to track the effectiveness of national policies and strategies, including providing critical information to support implementation and future development and improvement. our inventory showed that % of national ipc documents across all who regions addressed the need for both national and facility level monitoring and evaluation. these ranged from % in the western pacific region to % in the south-east asia region. therefore, national monitoring and evaluation is currently being recognized as a means to determine the effectiveness of ipc programmes. the panel recommends that regular monitoring/audit and timely feedback of health care practices according to ipc standards should be performed to prevent and control hais and amr at the facility level. feedback should be provided to all audited persons and relevant staff. (strong recommendation, low quality of evidence) evaluation of the evidence from six studies (one randomized controlled trial [ ] , two controlled before-after [ , ] , one interrupted time series [ ] , and two noncontrolled before-after [ , ] ) showed that the regular monitoring/auditing of ipc practices paired with regular feedback (individually and/or team/unit) is effective to increase adherence to care practices and to decrease overall hai. five studies were from high-income countries [ , , [ ] [ ] [ ] and one from an upper-middle-income country [ ] . due to varied methodologies and different outcomes measured, no meta-analysis was performed. the overall quality of evidence was low given the medium-to high-risk of bias across studies and the different study designs. however, the importance of the monitoring and feedback of ipc practices to demonstrate existing gaps and achieve health care workers' behavioural change toward good practices was recognized. therefore, the panel strongly recommended that audits and timely feedback to staff who influence the change of health care practices according to ipc standards should be performed regularly for the prevention of hai and amr. the panel recommends that a national ipc monitoring and evaluation programme should be established to assess the extent to which standards are being met and activities are being performed according to the programme's goals and objectives. hand hygiene monitoring with feedback should be considered as a key performance indicator at the national level. (strong recommendation, moderate quality of evidence) evaluation of the evidence from one sub-national study (randomized controlled trial [ ] ) showed that the national feedback of ipc monitoring data is effective to increase adherence to best practice in individual facilities and to decrease the device-associated infection rate. the quality of this study was graded as moderate. despite the limited evidence, the panel agreed that monitoring and evaluation should be an activity driven and coordinated by the national ipc programme and that this would be a strong recommendation. the panel also proposed that hand hygiene be considered as a key indicator for all national ipc programmes. overcrowding in health care facilities is recognized as being a public health issue that is associated with disease transmission. a combination of factors should be considered when determining the patient-to-bed ratio and the health care worker-to-patient ratio, including patient acuity, health care demand, and the availability of a trained workforce. these factors may interfere with providing optimal staff-to-patient ratio, which could potentially lead to increased rates of hai and the spread of amr. the panel recommends that the following elements should be adhered to in order to reduce the risk of hai and the spread of amr: ( ) bed occupancy should not exceed the standard capacity of the facility; ( ) health care worker staffing levels should be adequately assigned according to patient workload. (strong recommendation, very low quality of evidence) evaluation of the evidence from studies ( noncontrolled cohort [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , three case-control studies [ ] [ ] [ ] , one interrupted time series [ ] , one noncontrolled interrupted time series [ ] , one mixed methods [ ] and one cross-sectional [ ] ) showed that bed occupancy exceeding the standard capacity of the facility is associated with the increased risk of hai in acute care facilities, in addition to inadequate health care worker staffing levels. studies were all from high-income countries. mrsa transmission and infection were associated with bed occupancy in six studies [ - , , ] and the nurse-to-patient ratio in seven studies [ , , - , , ] . three studies reported that increases in nurse-to-patient ratios resulted in reduced hai [ , , ] , while inadequate adherence to hand hygiene protocols was associated with low staffing levels in one study and with high workload in another [ , ] . the overall quality of the evidence was very low. however, the panel unanimously decided to strongly recommend adherence to bed occupancy not exceeding the standard capacity of the facility and adequate health care worker staffing levels according to patient workload. when elaborating this recommendation, the panel considered the importance of these topics not only for reducing the risk of hai and the spread of amr, but also for achieving quality health service delivery in the context of universal health coverage. core component . built environment, materials and equipment for ipc at the facility level safe effective performance in the delivery of day-to-day patient care and treatment is crucial for optimal outcomes, both for patients and health care workers' health and safety. in an effort to promote effective and standardized clinical practice in accordance with guidelines, emphasis should be placed on optimizing the health care environment to ensure a work system that supports the effective implementation of ipc practices. hand hygiene is considered as the cornerstone of clinical practice and an essential measure for the prevention of hai and the spread of amr. who issued global guidelines including evidence-and consensus-based recommendations on hand hygiene in health care [ ] , together with an implementation strategy and toolkit (http://www.who.int/gpsc/ may/tools/en/). these are considered to be the gold standard and are implemented in many countries worldwide. a multimodal strategy is the internationally accepted approach to achieve hand hygiene behavioural change (component ). one of the five elements of the who hand hygiene improvement strategy relates to the work system within which hand hygiene takes place, i.e. an environment including an infrastructure and materials that facilitate compliance at the point of care. acute health care facility level only good practice statement general principle -patient care activities should be undertaken in a clean and/or hygienic environment that facilitates practices related to the prevention and control of hai, as well as amr, including all elements around the wash infrastructure and services and the availability of appropriate ipc materials and equipment. ensuring the provision of adequate appropriate materials, items and equipment in relation to wash services and their optimal placement or position are recognised as critical elements of human factors engineering (ergonomics), which support their appropriate use and increases compliance with good practices. ultimately, this contributes to the effective implementation and the attainment of the desired behaviour to support ipc. several environmental issues are of concern for ipc. the most relevant are those that deal with some features of the building design and wash-related conditions in the health care facility. the panel deemed it essential to describe the appropriate water and sanitation services, environment, and materials and equipment for ipc as a core component of effective ipc programmes in health care facilities. therefore, despite the absence of specific studies testing the effectiveness of these important aspects as interventions to reduce hai and amr, the panel decided to formulate a good practice statement to outline the most relevant elements for a safe environment supporting appropriate ipc practices. conversely, specific evidence was available on the importance of hand hygiene facilities. therefore, the panel also decided to develop a specific recommendation related to hand hygiene facilities. the panel recommends that materials and equipment to perform appropriate hand hygiene should be readily available at the point of care. (strong recommendation, very low quality of evidence) evaluation of the evidence from studies (one randomized controlled trial [ ] , four non-controlled beforeafter [ , [ ] [ ] [ ] ,and one qualitative study [ ] ) showed that the ready availability of equipment and products at the point of care leads to an increase in compliance with good practices and the reduction of hai. in six of the studies, the intervention consisted of the ready availability and optimal placement of hand hygiene materials and equipment in areas designated for patient care or where other health care procedures are performed and led to a significant increase in hand hygiene compliance. all studies were performed in highincome countries only. the overall quality of evidence was very low, but the panel decided to recommend that materials and equipment to perform hand hygiene should be readily available at all points of care. we discussed the evidence for an interrelated set of measures identified by an expert panel as contributing to reducing the risk of hai and combating amr at the national and acute health care facility level. it is important to note that although the recommendations for the facility level focus on acute health care facilities, the core principles and practices of ipc as a countermeasure to the development of hai are common to any facility where health care is delivered. therefore, these guidelines should be considered with some adaptations by community, primary care and long-term care facilities as they develop and review their ipc programmes. furthermore, while legal, policy and regulatory contexts may vary, these guidelines are relevant to both high-and low-resource settings as the need for effective ipc funding funding for the development of these guidelines was mainly provided by who. substantial additional funds were also gathered through the emergency grant aid kindly provided by the government of japan to prevent the ebola virus disease outbreak in west african countries and through the fleming fund kindly provided by the uk government. however, the views expressed do not necessarily reflect the official policies of the uk government. the databases generated and analyzed during the development of the guideline are available from the corresponding author on reasonable request. report on the endemic burden of healthcare-associated infection worldwide. geneva: world health organization burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis the direct medical costs of healthcare-associated infections in u.s. hospitals and the benefits of prevention report on the state of communicable diseases in the eu and eea/efta countries. stockholm: european centre for disease prevention and control the evolving threat of antimicrobial resistance -options for action. geneva: world health organization uk five year antimicrobial resistance strategy geneva: world health organization geneva: world health 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hygiene product usage in an intensive care unit handwashing in healthcare workers: accessibility of sink location does not improve compliance these guidelines were prepared and approved by the who guideline development group with formal approval via who's guideline review committee and do not necessarily reflect the opinions of antimicrobial resistance and infection control or its editors. this article is an abbreviated version of the full who guidelines on core components of infection prevention and control programmes at the national and acute healthcare facility level, which was published on november (www.who.int/gpsc/ipc-components/en/). the development of the guidelines was supervised by a who steering committee and we thank the following members edward kelley we also thank rosemary sudan for editing assistance, and tomas allen who provided assistance for the systematic review searches. programmes is universal across different cultures and contexts.indeed, adaptation to the local context, taking into account available resources, culture and public health needs, will be important in the implementation of the guideline recommendations. there is also a particular need for careful evaluation of feasibility and costs in low-resource settings. adoption should be facilitated by sound implementation strategies and practical tools. it is important to note that who is about to develop an implementation strategy and tools for the ipc core components at the national and facility level, including specific guidance for settings with limited resources. authors' contributions js and ba co-led the writing of the manuscript and the development of the who guidelines on core components for infection prevention and control programmes at the national and acute health care facility level and contributed to the systematic reviews. at substantially contributed to the writing of the manuscript and to the development of the who guidelines, including the performance and interpretation of the update of the sight systematic review. wz, nd, ck, jr lp and me contributed to the writing of the manuscript and to the development of the who guidelines, including the performance and interpretation of the systematic reviews. mlg was chair of the expert panel who developed the who guidelines. mlg and ek contributed to the writing of the manuscript and to the development of the who guidelines. all authors read and approved the final manuscript. the authors declare that they have no competing interests. submit your next manuscript to biomed central and we will help you at every step: key: cord- -er lvhn authors: farewell, charlotte v.; jewell, jennifer; walls, jessica; leiferman, jenn a. title: a mixed-methods pilot study of perinatal risk and resilience during covid- date: - - journal: j prim care community health doi: . / sha: doc_id: cord_uid: er lvhn introduction/objectives: national guidelines underscore the need for improvement in the detection and treatment of mood disorders in the perinatal period. exposure to disasters can amplify perinatal mood disorders and even have intergenerational impacts. the primary aim of this pilot study was to use mixed-methods to better understand the mental health and well-being effects of the coronavirus disease (covid- ) pandemic, as well as sources of resilience, among women during the perinatal period. methods: the study team used a simultaneous exploratory mixed-methods design to investigate the primary objective. thirty-one pregnant and postpartum women participated in phone interviews and were invited to complete an online survey which included validated mental health and well-being measures. results: approximately % of the sample reported high depressive symptomatology and % reported moderate or severe anxiety. forty percent of the sample reported being lonely. the primary themes related to stress were uncertainty surrounding perinatal care, exposure risk for both mother and baby, inconsistent messaging from information sources and lack of support networks. participants identified various sources of resilience, including the use of virtual communication platforms, engaging in self-care behaviors (eg, adequate sleep, physical activity, and healthy eating), partner emotional support, being outdoors, gratitude, and adhering to structures and routines. conclusions: since the onset of covid- , many pregnant and postpartum women report struggling with stress, depression, and anxiety symptomatology. findings from this pilot study begin to inform future intervention work to best support this highly vulnerable population. pregnancy and the first months postpartum (perinatal period) can be inherently challenging, often leading to lack of sleep, relationship tensions, and feelings of isolation. these challenges result in the development of mood disorders for many women. for example, the prevalence of prenatal and postpartum depression is estimated at % and %, respectively. [ ] [ ] [ ] exposure to environmental stressors, such as natural disasters, can amplify perinatal mood disorders and even have intergenerational impacts on child health and development outcomes. [ ] [ ] [ ] [ ] health care providers are often the primary source of mental health resources and care for women during the perinatal period, indicating a significant role of providers in helping to identify and manage (eg, treat/refer) perinatal mood disorders. , however, a prior study found that maternal depression is assessed in primary care settings less than % of the time, and the use of screening tools is even lower ( %- %). national guidelines underscore the need for improvement in the detection and treatment of mood disorders in the perinatal period, particularly among those vulnerable to environmental stressors. , many studies have explored the impacts of disasters, or events that cause disruption exceeding the adjustment capacity of the affected community, on mental health and have found that prenatal and postpartum women may experience significantly higher rates of mood disorders during disasters compared with the general population. , in january , the world health organization (who) declared the outbreak of a new coronavirus disease, covid- , to be a public health emergency of international concern. according to similar epidemics and pandemics, stress coupled with feelings of loneliness and anger can develop among people who are quarantined. additionally, social isolation during environmental disasters, such as covid- , may lead to decreased social connections, which can further exacerbate feelings of isolation and perinatal mood disorders. although current studies are exploring the specific impacts of covid- on population mental health, less is known about the mental health implications specifically related to perinatal mental health during covid- . additionally, better understanding of potential factors that may be protective for perinatal women during a pandemic, such as social supports and/or coping strategies is warranted. resilience in the face of disasters is likely to result from a combination of resources that foster the ability to cope well despite extraordinarily severe demands. the primary aim of this pilot study was to use mixed-methods to better understand mental health and well-being, as well as sources of resilience, for women in the perinatal period during the covid- pandemic. these findings have implications related to prenatal and postpartum health care among women exposed to disasters and large-scale traumatic events. ethical approval for this pilot study was obtained from the colorado multiple institutional review board (# - ). rolling recruitment for this study occurred between march and april using a purposive, nonprobabilistic sampling method. the targeted audience for this study included mothers who met the following criteria: ( ) over the age of years, ( ) english-speaking, ( ) currently living in colorado, and ( ) being pregnant or within the first -months postpartum. women were recruited through advertisements posted on social media outlets (eg, facebook, mom listservs). women who met the eligibility criteria and who were interested in participating in the study completed an online consent form. women were contacted by a member of the study team to schedule a time for a phone interview within hours of completing the online consent form. the study team used a simultaneous exploratory mixedmethods design to investigate the primary objective. qualitative methods. prior to the interview, participants were provided information about how the interview would be conducted. two members of the research team conducted the phone interviews (first, cvf, and last author, jal); interviews averaged minutes, ranging from to minutes. the interview protocol consisted of a semistructured tool including a combination of open-ended questions related to sources of stress, sources of support and coping, self-care and well-being, beliefs around covid risks, and impacts on care plans. example questions included, "in general, how has the covid- pandemic impacted your pregnancy experience thus far?" and "how has the pandemic changed your expectations around parenting?" participants were provided mental health resources at the conclusion of interviews. qualitative analysis. the interviewers took extensive notes throughout the phone interviews. qualitative data analysis followed best practice methods for qualitative research, including a deductive, theory-driven approach, and an inductive, data-driven approach. , one of the interviewers (first author, cvf) coded the interviews using nvivo software and constant comparison analysis. the codebook contained a priori codes that aligned with sources of stress (eg, social isolation) and resilience (eg, social supports) from the literature. inductive coding was also used to allow for discovery of unique sources of risk and resilience. a second coder (jal) reviewed all transcripts, summarized themes and subthemes and compared findings with the first coder. if disconcordance on the meaning of the codes and themes were present, a discussion occurred between the coders to reach consensus on the coding structure. quantitative methods. after completing the interview, participants were sent an electronic link to a -item online survey. the survey took approximately minutes to complete. the survey included measures of sociodemographic factors, coping behaviors, and several validated measures for mental health and well-being, including: the patient health questionnaire- (phq- ), which is a brief measure of depression with a range of to and a cutoff score of ≥ ; the generalized anxiety disorder- (gad- ) scale, which is a brief measure of anxiety with a range of to and a cutoff score of ≥ ; the brief resilience scale (brs), which measures resilience and ranges from to with higher scores indicating more resilience; the warwick-edinburgh mental wellbeing scale (wemwbs), which measures subjective well-being and ranges from to with higher scores indicating higher well-being; and the -item loneliness scale, which measures loneliness and has a cutoff of ≥ and a range of to . after completion of both the phone interview and online survey, participants were randomly selected to receive of usd gift cards. quantitative analysis. descriptive statistics were conducted to investigate the primary variables of interest in the quantitative data, including demographics, mental health and well-being measures and reported coping behaviors. thirty-one interviews were conducted and of the participants completed the online survey. approximately half of the interview participants were pregnant ( %) and half were within months postpartum ( %). fifty percent of the pregnant sample were primigravid and % of the postpartum sample had only one child. table displays sample characteristics of the participants who completed the survey and descriptives related to the primary variables of interest. approximately % of the sample reported high depressive symptomology and % reported moderate or severe anxiety symptomatology. about two-thirds of the sample ( %) reported experiencing at least moderate stress, and participants scored an average of on the well-being scale (range = - ) and an average of . on the resilience scale (range = . - . ). forty percent of the sample reported being lonely. participants reported that the most common ways they were coping included texting with friends ( %), video/phone calls with friends ( %) and sleeping ( %). the primary themes, subthemes, and illustrative quotes from the qualitative data are summarized in table . pregnant women most commonly expressed stress surrounding "unknowns" related to prenatal care appointment rules, birth plan expectations, and prenatal exposure risk. for example, one woman shared, "i anticipate the birthing experience will be quite different, and i'm just hoping the hospital i'm delivering in will allow my husband to be there. it's just not knowing what's going to happen right now." among new mothers, uncertainty and stress were related to newborn risk exposure. one mother said, "and when it comes to health, like with having a new baby, i'm not an expert and i don't know how worried i should be. i need someone to tell me . . ." lack of consistent messaging and clear guidance surrounding recommendations and care appointments from providers was a concern shared by both pregnant women and new mothers. one pregnant woman said, "i feel like we get all these mixed-messages about it." another pregnant woman said, "i mean online appointments have been fine, but i guess the healthcare system doesn't really know what they're doing, and they are trying to be nimble and they haven't let me know in advance about who i'm seeing or if i'm allowed to come in until the last minute." pregnant women reported feelings of isolation and loneliness as well as lack of postpartum support networks. women shared that being pregnant during covid- resulted in less excitement surrounding the pregnancy because of social isolation. one woman said, "it's made it definitely a more somber experience and it has been difficult to be excited because you can't share it with people." pregnant women also talked about concerns over postpartum supports. one woman shared, "well, we were counting on support from grandparents on both sides and we can't anymore." new moms frequently cited stressors related to lack of daycare and caregiver supports, and social isolation. one mother said, "it has made it a lot harder, mainly that i don't have childcare and i was planning on going back to work but now i can't." new moms shared that social isolation was significantly affecting their postpartum mental health. a mother said, "and now feeling even more isolated than normal because if we go for a walk now i use the ergobaby instead of the stroller so i can keep her covered." pregnant women and new moms shared that partner support was the primary factor that helped them cope. one new mom shared, "we [partners] are alternating like some days he's stressed and anxious and sometimes i will be. and we're like we need to get through this together." emotional support was cited as the most helpful source of support among all mothers. one mom said, "being able to connect with newer moms with similar aged babies and go around and share with everyone on zoom." all women shared that getting outdoors and being in nature was helping them cope. one pregnant woman said, "just being outside. i always go to the park and just breathe." women also said that focusing on gratitude promoted their mental health. for example, one new mom said, "feeling grateful for all this special time with my kids and to have all this intense family time." finally, women in both the prenatal and postpartum periods shared that managing expectations was protective. one pregnant woman shared, "just sort of having to adjust expectations because none of this is how we imagined pregnancy would be." among new mothers, structures and routines were cited as a factor that helped them cope. one mom said, "so completely resetting daily routines and coordinating work schedules and full-time parenting" and "staying on schedule has helped with staying mentally well too." participants shared a variety of positive impacts related to the covid- pandemic. pregnant woman said that being able to work from home allowed for more time to prioritize self-care, which improved their mental and physical health. new mothers highlighted numerous positive benefits including increased connection and bonding with their immediate family unit, partner supports in the home to share caregiving responsibilities, and increased access to remote postnatal and postpartum care. one mom said, "my husband is home full-time and that has been so helpful just to not be alone. i can really focus on her and my husband and our family time." another mother shared, i've been connected with postpartum behavioral health support and that has been virtual which is really great actually because i'm not sure how otherwise i would be able to go. in that way it has allowed me to seek those types of services more. both pregnant women and new mothers shared additional positive impacts of the covid- pandemic including not missing out on social activities and spending less money. one mom said, "i think the biggest positive is that i didn't have that feeling of missing out . . . my friends weren't posting cool things that i was missing out on," and a pregnant woman said, "we are spending less because we aren't going out." these findings highlight the additional toll of the covid- pandemic on perinatal mental health in the united states. the quantitative findings suggest that the pandemic has resulted in elevated rates of mood disorders for this sample of pregnant and postpartum women. perinatal anxiety rates were approximately six times higher in this sample compared to pre-pandemic perinatal rates in colorado. additionally, participants reported lower well-being and lower levels of resilience compared to pre-pandemic scores. the qualitative component of this study illustrated sources of stress that further explain these quantitative findings. the burden of uncertainty related to health care services and risk exposure for all women was a salient theme. harville et al similarly found that after hurricane katrina, stressors experienced by perinatal women included the interruption of health care services, clinical infrastructure and referrals and the lack of knowledge surrounding early term exposure. alternative studies found that uncertainties lead to heightened fears of contracting or transmitting infection and fears surrounding separation from the infant at birth. almost half of the sample reported feeling lonely, and this social isolation may explain the high rates of anxiety and poor well-being and resilience reported in this sample of pregnant and postpartum women. social isolation was a common theme shared by both pregnant and postpartum women in the qualitative data and align with the prevalence of loneliness reported in the sample. social distancing and isolation during disasters, coupled with lack of access to health care professionals, can lead to heightened intimate partner violence, , which can affect maternal mood disorders and adverse pregnancy and birth outcomes. additionally, lack of caregiver social supports in the postpartum period are linked to poor maternal psychological well-being. sources of resilience were identified in these data and are supported by past research that has explored resilience among perinatal women during disasters. virtual media platforms (texting, video calls), , and engaging in selfcare behaviors such as getting recommended sleep and exercise were identified as protective coping behaviors in the quantitative data. qualitative data suggested that social support, and specifically partner and emotional support, gratitude and optimism, , and the management or shifting of expectations were significant protective factors for pregnant and postpartum women, particularly during exposure to significant environmental stressors. however, the high rates of depression, anxiety, and stress identified in this sample suggest that quarantine and social isolation regulations may increase need for supports and protective coping behaviors. limitations of this pilot study include the small sample size, minimal diversity, lack of consideration of pregnancy and birth complications, and the recruitment strategy, which relied solely on social media platforms and may limit the generalizability of these findings. additionally, approximately half of the pregnant sample were pregnant with their first baby and over a third of the postpartum sample were first-time moms. mental health and associated factors may vary by primigravid and multigravida women. [ ] [ ] [ ] larger studies are needed to increase generalizability and to compare the unique experiences of stress during covid- among these different groups. however, this study may have implications for health care providers who are providing care for pregnant and postpartum women during the covid- pandemic. table displays provider recommendations to help mitigate perinatal mood disorders and promote resilience based on these preliminary findings. examples include screening all perinatal women for depression and anxiety during healthcare visits and providing positive coping behavior recommendations via hand-outs during prenatal and postpartum care visits. collectively, these data suggest that covid- has amplified the rates of perinatal mood disorders among this sample of perinatal women. • alert pregnant women to information regarding appointment rules and regulations (eg, supports) as early as possible in the pregnancy • • address uncertainty surrounding covid- and impacts on perinatal health and direct to evidence-based sources of information • • screen all prenatal and postpartum women for depression/anxiety during health care visits promote perinatal resilience and positive coping • • provide coping suggestions and recommendations in the form of hand-outs/one-pagers during prenatal and postpartum care visits. recommended topics include remote and safe ways to promote social connection, outdoors benefits, gratitude, managing expectations related to birthing/delivery, and self-care behaviors (physical activity, stress management, sleep) • • increase opportunities for social connection during prenatal and postpartum tele-health classes • • provide resources related to mental health supports and care for all prenatal and postpartum women exposure to prenatal psychobiological stress exerts programming influences on the mother and her fetus prevalence and incidence of postpartum depression among healthy mothers: a systematic review and meta-analysis a 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acknowledge all pregnant and postpartum women who participated in this study and shared their experiences. key: cord- -knlc bxh authors: holmes, emily a; o'connor, rory c; perry, v hugh; tracey, irene; wessely, simon; arseneault, louise; ballard, clive; christensen, helen; cohen silver, roxane; everall, ian; ford, tamsin; john, ann; kabir, thomas; king, kate; madan, ira; michie, susan; przybylski, andrew k; shafran, roz; sweeney, angela; worthman, carol m; yardley, lucy; cowan, katherine; cope, claire; hotopf, matthew; bullmore, ed title: multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science date: - - journal: lancet psychiatry doi: . /s - ( ) - sha: doc_id: cord_uid: knlc bxh the coronavirus disease (covid- ) pandemic is having a profound effect on all aspects of society, including mental health and physical health. we explore the psychological, social, and neuroscientific effects of covid- and set out the immediate priorities and longer-term strategies for mental health science research. these priorities were informed by surveys of the public and an expert panel convened by the uk academy of medical sciences and the mental health research charity, mq: transforming mental health, in the first weeks of the pandemic in the uk in march, . we urge uk research funding agencies to work with researchers, people with lived experience, and others to establish a high level coordination group to ensure that these research priorities are addressed, and to allow new ones to be identified over time. the need to maintain high-quality research standards is imperative. international collaboration and a global perspective will be beneficial. an immediate priority is collecting high-quality data on the mental health effects of the covid- pandemic across the whole population and vulnerable groups, and on brain function, cognition, and mental health of patients with covid- . there is an urgent need for research to address how mental health consequences for vulnerable groups can be mitigated under pandemic conditions, and on the impact of repeated media consumption and health messaging around covid- . discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of the pandemic are required. rising to this challenge will require integration across disciplines and sectors, and should be done together with people with lived experience. new funding will be required to meet these priorities, and it can be efficiently leveraged by the uk's world-leading infrastructure. this position paper provides a strategy that may be both adapted for, and integrated with, research efforts in other countries. it is already evident that the direct and indirect psychological and social effects of the coronavirus disease (covid- ) pandemic are pervasive and could affect mental health now and in the future. the pandemic is occurring against the backdrop of increased prevalence of mental health issues in the uk in recent years in some groups. , furthermore, severe acute respiratory syndrome coronavirus (sars-cov- ), the virus that causes covid- , might infect the brain or trigger immune responses that have additional adverse effects on brain function and mental health in patients with research funders and researchers must deploy resources to understand the psychological, social, and neuroscientific effects of the covid- pandemic. mob ilisation now will allow us to apply the learnings gained to any future periods of increased infection and lockdown, which will be particularly important for front-line workers and for vulnerable groups, and to future pandemics. we propose a framework for the prioritisation and coordination of essential, policy-relevant psychological, social, and neuroscientific research, to ensure that any investment is efficiently targeted to the crucial mental health science questions as the pandemic unfolds. we use the term mental health sciences to reflect the many different disciplines, including, but not limited to, psychology, psychiatry, clinical medicine, behavioural and social sciences, and neuroscience, that will need to work together in a multidisciplinary fashion together with people with lived experience of mental health issues or covid- to address these research priorities. the uk has powerful advantages in mounting a successful response to the pandemic, including strong existing research infrastructure and expertise, but the research community must act rapidly and collaboratively if it is to deal with the growing threats to mental health. a fragmented research response, characterised by smallscale and localised initiatives, will not yield the clear insights necessary to guide policy makers or the public. rigorous scientific and ethical review of protocols and results remains the cornerstone of safeguarding patients and upholding research standards. deploying a mental health science perspective to the pandemic will also inform population-level behaviour change initiatives aimed at reducing the spread of the virus. international comparisons will be especially helpful in this regard. in this position paper, we explore the psychological, social, and neuroscientific effects of covid- and set out clear immediate priorities and longer-term strategies for each of these aspects. we also surveyed the public and people with lived experience of mental ill-health (panel ). the general population survey, done by ipsos mori, revealed widespread concerns about the effect of social isolation or social distancing on wellbeing; increased anxiety, depression, stress, and other negative feelings; and concern about the practical implications of the pandemic response, including financial difficulties. the prospect of becoming physically unwell with covid- ranked lower than these issues related to the social and psychological response to the pandemic. the mq: transforming mental health stakeholder survey of people with lived experience of a mental health issue likewise highlighted general concerns about social isolation and increased feelings of anxiety and depression. more specifically, stakeholders frequently expressed concerns about exacerbation of pre-existing mental health issues, greater difficulty in accessing mental health support and services under pandemic conditions, and the effect of covid- on the mental health of family members, especially children and older people. both surveys are reported online. these findings, combined with the published scientific literature, informed the development of our research priorities. the surveys represent a snapshot of the current situation, but they will need to be repeated more rigorously over the course of the pandemic, and the research priorities reviewed. in this section, we focus on the psychological processes and effects in individual people related to covid- , such as cognition, emotion, and behaviour, that affect mental health (table ) . although a rise in symptoms of anxiety and coping responses to stress are expected during these extraordinary circumstances, there is a risk that prevalence of clinically relevant numbers of people with anxiety, depression, and engaging in harmful behaviours (such as suicide and selfharm) will increase. of note, however, is that a rise in suicide is not inevitable, especially with national mitigation efforts. the potential fallout of an economic downturn on mental health is likely to be profound on those directly affected and their caregivers. the severe acute respiratory syndrome epidemic in was associated with a % increase in suicide in those aged years and older; around % of recovered patients remained anxious; and % of health-care workers experienced probable emotional distress. [ ] [ ] [ ] patients who survived severe and life-threatening illness were at risk of post-traumatic stress disorder and depression. , many of the anticipated consequences of quarantine and associated social and physical distancing measures are themselves key risk factors for mental health issues. these include suicide and self-harm, alcohol and substance misuse, gambling, domestic and child abuse, and psychosocial risks (such as social disconnection, lack of meaning or anomie, entrapment, cyberbullying, feeling a burden, financial stress, bereavement, loss, unemployment, homelessness, and relationship breakdown). [ ] [ ] [ ] a major adverse consequence of the covid- pandemic is likely to be increased social isolation and loneliness (as reflected in our surveys), which are strongly associated with anxiety, depression, self-harm, and suicide attempts across the lifespan. , tracking loneliness and intervening early are important priorities. crucially, reducing sustained feelings of loneliness and promoting belongingness are candidate mechanisms to protect against suicide, self-harm, and emotional this position paper summarises the priorities put forward by an interdisciplinary group of world-leading experts, including people with lived experience of a mental health issue, from across the bio-psycho-social spectrum of expertise in mental health science in march and april, . the experts were convened by the uk academy of medical sciences and the mental health research charity, mq: transforming mental health. members participated in an individual capacity, not as representatives of their organisations. a coordinating group of seven experts met daily over a period of two weeks to develop the research priorities, informed by input from the expert advisory group. given the need to develop the research priorities rapidly to inform immediate funding priorities, extended evidence gathering and consultation was not possible. however, we are confident that the wide breadth of expertise on the expert group and their leading roles in their respective fields provide a wide-ranging and comprehensive view of the mental health and neuroscience research priorities now; priorities which should be reviewed and should evolve with the pandemic. lived experience of a mental health issue was incorporated by four mechanisms. first, three representatives with lived experience provided input as part of the expert advisory group. second, an online survey collected data on people's two biggest concerns about the mental health and wellbeing implications of the coronavirus disease (covid- ) pandemic and the coping strategies used by patients. the survey was promoted via email to mq's supporter network and via social media. in total, people completed the survey, submitting concerns about the mental health effects of the covid- pandemic and responses about what has helped to maintain mental health and wellbeing during the pandemic. a thematic analysis of the full dataset was done. third, two questions were asked on ipsos mori's online omnibus survey to collect data on people's concerns about the effect of covid- on mental wellbeing and what is helping people's mental wellbeing at this time. in total, interviews were completed with adults aged between and years from across england, wales, and scotland. quotas were set and data were weighted to the offline population to ensure a nationally representative sample by gender, age, and region. statistical analysis was done and any subgroup differences included are statistically significant at a % confidence interval unless stated otherwise. a summary report of the findings of both surveys and further methodological details can be found online. the ipsos mori tabular data can be found on its website. finally, the manuscript was peer-reviewed by a reviewer with lived experience of a mental health issue. we acknowledge the limitations of our surveys, including the representativeness of the mq sample, the short timescale for input, and the representativeness of online populations. we also acknowledge the restricted evidence gathering and opportunity for wider consultation of people with lived experience. however, combined, these four mechanisms of collecting input from people with lived experience provide important insight into people's concerns about the effect of covid- on mental health and coping strategies within the very short timeframe. problems. , social isolation and loneliness are distinct and might represent different risk pathways. to inform management of covid- , it is vital to understand the socioeconomic effect of the policies used to manage the pandemic, which will inevitably have serious effects on mental health by increasing unemployment, financial insecurity, and poverty. , involvement of people with lived experience and rapid qualitative research with diverse people and communities will help to identify ways in which this negative effect might be alleviated. achieving the right balance between infection control and mitigation of these negative socioeconomic effects must be considered. the immediate research priorities are to monitor and report rates of anxiety, depression, self-harm, suicide, and other mental health issues both to understand mechanisms and crucially to inform interventions. this should be adopted across the general population and vulnerable groups, including front-line workers. monitoring must go beyond nhs record linkage to capture the real incidence in the community, because self-harm might become more hidden. we must harness existing datasets and ongoing longitudinal studies, and establish new cohorts with new ways of recording including detailed psychological factors. , techniques assessing moment to moment changes in psychological risk factors should be embraced. given the unique circumstances of covid- , data will be vital to determine causal mechanisms associated with poor mental health, , including loneliness and entrapment. to optimise effectiveness of psychological treatments, they need to be mechanistically informedthat is, targeting factors which are both causally associated with poor mental health and modifiable by an intervention. a one-size-fits-all response will not suffice because the effectiveness of interventions can vary across groups. , [ ] [ ] [ ] [ ] digital psychological interventions that are mechanistically informed, alongside better understanding of the buffering effects of social relationships during stressful events, are required in the long term. the digital response is crucial, [ ] [ ] [ ] not only because of social isolation measures but also because less than a third of people who die by suicide have been in contact with mental health services in the months before death. digital interventions for anxiety, depression, self-harm, and suicide include information provision, connectivity and triage, automated and blended therapeutic interventions (such as apps and online programmes), telephone calls and messages to reach those with poorer digital resources (digital poverty), suicide risk assessments, chatlines and forums, and technologies that can be used to monitor risk either passively or actively. the digital landscape extends beyond apps and requires an evidence base. artificial intelligence-driven adaptive trials could help to evaluate effectiveness, while digital phenotyping could be helpful to ascertain early warning signs for mental ill-health. looking beyond digital interventions (as not everyone has access to them), and ascertaining what other mechanistically based psychological interventions are effective and for whom is important. , risks and buffers for loneliness should be a focal target in interventions to protect wellbeing. the longer-term consequences of covid- for the younger and older generations (and other groups at high risk, including workers, those with existing mental health conditions, and caregivers) are also unknown and must be a priority. how do individuals build optimal structures for a mentally healthy life that works for them in the wake of covid- and social and physical distancing? the optimal structure of a mentally healthy life for individuals in the wake of covid- needs to be mapped out. structure will vary as a function of background and individual circumstances. changes in sleep and lifestyle behaviours influence our mental health and stress response. understanding the effective, individualised ways of coping in such a situation is of paramount importance. [ ] [ ] [ ] the social and personal resources (eg, seeing family and getting sufficient sleep) available to individuals can be important resiliencerelated factors for mitigating mental health difficulties under particularly stressful circumstances. we need what is the effect of covid- on risk of anxiety, depression, and other outcomes, such as self-harm and suicide? improve monitoring and reporting of the rates of anxiety, depression, self-harm, suicide, and other mental health issues; determine the efficacy of mechanistically based digital and non-digital interventions and evaluate optimal model(s) of implementation determine the mechanisms (eg, entrapment and loneliness) that explain the rates of anxiety, depression, self-harm, and suicide; understand the role of psychological factors in buffering the effect of social context on mental health issues; ascertain the longer-term consequences on wellbeing of covid- for the young and older generations (and vulnerable groups) what is the optimal structure for a mentally healthy life in the wake of covid- and social or physical distancing? determine what psychological support is available to help front-line medical and health-care staff and their families; understand the psychological (eg, coping), physiological (eg, sleep and nutrition), and structural (eg, work rotas and daily routines) factors that protect or adversely affect mental health the immediate research priorities are to understand how front-line health and social care staff and their families can be supported to optimise coping strategies to mitigate symptoms of stress, and facilitate the imple mentation of preventive interventions in the future. , during the covid- pandemic, it is important that health and social care workers are supported to stay in work, the health, personal, social, and economic benefits of which are vast. personalised psychological approaches are likely to be a key component to address complex mental health conditions, coping mechanisms, and prevention. given the association between sleep disturbance and mental health, and the effect of sleep disturbance on the risk of suicide, research on mitigating the effect of such changes on mental health and stress response is required. the longer-term strategic research programmes are to develop novel interventions to protect mental wellbeing, including those based on positive mechanistically based components (ie, causal, modifiable factors), such as altruism and prosocial behaviour. this could include increased opportunities to elicit community support, , exercise, social activities, training in assertiveness and conflict resolution, and group interventions that provide support through peers. the inclusion of altruism in uk government health messages has likely had a positive effect on wellbeing compared with compulsory orders to stay at home. key research questions include "what positive mechanistically based psychological interventions can be developed for mental wellbeing derived from theories of altruism and prosocial behaviour?" and "what can be learned from the large-scale roll-out of volunteer-based psychological interventions that will optimise the benefits to individuals and society?" working from home, loss of employment, and social and physical distancing have abruptly interrupted many social opportunities important to physical and psychological health. it is important to research the mental health dimension of online life and investigate how changes in engagement with gaming and online platforms might inform interventions aimed at improving mental health. we must rapidly learn from successful existing strategies to maintain and build social resources and resilience and promote good mental health in specific populations moving forward. population-level factors, such as the effect of social distancing measures (more recently being redescribed as physical distancing) and other necessary public health measures, affect mental health within a syndemics approach (table ) . by syndemics we mean intersecting global trends among demographics (eg, ageing, rising inequality) and health conditions (eg, chronic diseases and obesity) that yield resultant comorbidities. these longer-term strategic programmes what are the mental health consequences of the covid- lockdown and social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions? determine the best ways of signposting and delivering mental health services for vulnerable groups, including online clinics and community support; identify and evaluate outreach methods to support those at risk of abuse within the home; ascertain which evidence-based interventions can be rapidly repurposed at scale for the covid- pandemic, and identify intervention gaps requiring bespoke remotely delivered interventions to boost wellbeing and reduce mental health issues; swiftly provide interventions to promote mental wellbeing in front-line health-care workers exposed to stress and trauma that can be delivered now and at scale on the basis of the intervention gaps identified, design bespoke approaches for population-level interventions targeted at the prevention and treatment of mental health symptoms (eg, anxiety) and at boosting coping and resilience (eg, exercise); develop innovative novel universal interventions on new mechanistically based targets from experimental and social sciences (eg, for loneliness consider befriending) that can help mental health; assess the effectiveness of arts-based and life-skills based interventions and other generative activities including exercise outdoors what is the effect of repeated media consumption about covid- in traditional and social media on mental health, and how can wellbeing be promoted? understand the role of repeated media consumption in amplifying distress and anxiety, and optimal patterns of consumption for wellbeing; develop strategies to prevent over-exposure to anxiety-provoking media, including how to encourage diverse populations to stay informed by authoritative sources they trust; mitigate and manage the effect of viewing distressing footage inform evidence-based media policy around pandemic reporting (eg, clearly identify authoritative sources, encourage companies to correct disinformation, and policies on traumatic footage); mitigate individuals' risk of misinformation (eg, improve health literacy and critical thinking skills and minimise sharing of misinformation); understand and harness positive uses of traditional media, online gaming, and social media platforms what are the best methods for promoting successful adherence to behavioural advice about covid- while enabling mental wellbeing and minimising distress? understand how health messaging can optimise behaviour change, and reduce unintended mental health issues; track perceptions of and responses to public health messages to allow iterative improvements, informed by mental health science synthesise evidence base of lessons learned for future pandemics, tailored to specific groups as required; motivate and enable people to prepare psychologically and plan practically for possible future scenarios; understand the facilitators and barriers for activities that promote good mental health, such as exercise; promote people's care and concern for others, fostering collective solidarity and altruism covid- =coronavirus disease . interacting health effects and societal forces that fuel them combine to form syndemics, or complex knots of health determinants. research priorities around covid- require us to embrace complexity by deploying multidimensional perspectives. what are the mental health consequences of the covid- lockdown and social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions? we do not yet know the acute or long-term con sequences of the covid- lockdown and social isolation on mental health. although worries and uncertainties about a pandemic are common, for some they can cause undue distress and impairment to social and occupational functioning. , , across society, a sense of loss can stem from losing direct social contacts, and also range from loss of loved ones, to loss of employment, educational opportunities, recreation, freedoms, and supports. existing evidence suggests some measures taken to control the pandemic might have a disproportionate effect on those most vulnerable (panel ). vulnerable groups include those with pre-existing mental or physical health issues (including those with severe mental illnesses), recovered individuals, and those who become mentally unwell (eg, in response to anxiety and loneliness surrounding the pandemic; panel ). , , therefore, loss of access to mental health support, alongside loss of positive activities, might increase vulnerability during covid- lockdown. increased feelings of anxiety and depression in response to the outbreak have been highlighted already. health workers who come in close contact with the virus and are exposed to traumatic events, such as death and dying, while making highly challenging decisions, are particularly at risk of stress responses. the pandemic intersects with rising mental health issues in childhood and adolescence. , , ascertaining and mitigating the effects of school closures for youth seeking care is urgent and essential, given that school is often the first place children and adolescents seek help, , as is considering vulnerabilities, such as special educational needs and developmental disorders, and finding therapeutic levers. for the older population, promoting good mental health is important during self-isolation, which can be compounded by lifestyle restrictions, exacerbated loneliness, comorbidities (such as dementia), and feelings of worry and guilt for using resources. there is an acute need to identify, in consultation with people with lived experience, remotely delivered interventions that support those at risk of abuse. , the immediate research priorities are to reduce mental health issues and support wellbeing in vulnerable groups in particular. a coordinating mechanism for pandemic mental health interventions is required for the agile identification of interventions that can be repurposed, alongside the identification of intervention gaps that will require bespoke de novo design, and the evaluation and roll-out of remotely delivered interventions. by the term intervention, we mean interventions of all sorts that make a difference to mental health, including populationlevel policy, occupational guidelines, and psychological interventions. we need to gather high-quality data rapidly to ascertain the effects of lockdown and social isolation over time. innovative research is needed to establish ways to mitigate and manage mental health risks and inform interventions under pandemic conditions. research to support vulnerable groups needs to consider cross-cutting themes (such as the physical absence of schools and clinics) to create methods to provide connectivity and support; promote rapid innovation in mental although the whole population is affected by the coronavirus disease pandemic, specific sections of the population will experience it differently. children, young people, and families will be affected by school closures. they might also be affected by exposure to substance misuse, gambling, domestic violence and child maltreatment, absence of free school meals, accommodation issues and overcrowding, parental employment, and change and disruption of social networks. older adults and those with multimorbidities might be particularly affected by issues including isolation, loneliness, end of life care, and bereavement, which may be exacerbated by the so-called digital divide. people with existing mental health issues, including those with severe mental illnesses, might be particularly affected by relapse, disruptions to services, isolation, the possible exacerbation of symptoms in response to pandemic-related information and behaviours, and changes in mental health law. front-line health-care workers might be affected by fears of contamination, moral injury, disruption of normal supportive structures, work stress, and retention issues. people with learning difficulties and neurodevelopmental disorders might be affected by changes and disruption to support and routines, isolation, and loneliness. society might experience increased social cohesion and communitarianism, but also be negatively affected by increased health inequalities, increased food bank use, increased race-based attacks, and other trauma. rural communities might also be affected differently to urban communities. socially excluded groups, including prisoners, the homeless, and refugees, might require a tailored response. people on low incomes face job and financial insecurity, cramped housing, and poor access to the internet and technology. health services that can be remotely signposted and delivered (including online clinics and community support); identify and evaluate means to support those at risk of abuse within the home (eg, online outreach); and swiftly provide interventions to promote mental wellbeing in front-line health workers. by identifying cross-cutting research themes, interventions to help specific vulnerable populations should be leveraged to help other vulnerable groups. with regard to the longer-term priorities, health services research must reliably and iteratively inform remotely delivered mental health resources, such as digital clinics, to efficiently manage mental health issues in an adaptive and flexible manner. this requires a coordinating mechanism to prioritise and streamline efforts, working with service users to optimise signposting and delivery and define therapeutic targets that matter from a user perspective (eg, loss, loneliness). such a mechanism requires a range of disciplines, including psychology, digital science, and social sciences. , international collaboration will ensure the necessary research skills and expertise. research should harness internet-based social media and gaming using existing platforms and be cognisant of the so-called digital divide, which leaves % of britons without internet access. research for population-level interventions will require rapid evolution of approaches, starting with testing whether existing digital interventions can be repurposed, such as physical activity, sleep, and stress management programmes, as well as targeted approaches for the prevention and treatment of established mental health symptoms (eg, anxiety and worry). , tailoring of such universal interventions will need to be informed by exper imental and social science (eg, for loneliness, befriending, and physical activity). , the effectiveness of arts-based interventions also needs to be assessed as do other generative activities that boost positive coping and resilience throughout society, from community-based activities, to life-skills classes, to exercising outdoors. the effectiveness of all interventions requires rigorous evaluation and implementation to avoid recommending a plethora of apps with no evidence base. interventions at the population level should be repurposed, developed, and tested in a virtuous loop to create the necessary evidence base. what is the effect of repeated media consumption about covid- through traditional media and social media on mental health, and how can wellbeing be promoted? people seek trusted information via the media, which can provide swift, critical guidance regarding the pandemic. media consumption can be adaptive and positive for mental health. however, reports of infectious diseases often use risk-elevating messages, which can amplify public anxiety. social media can be a source of rapidly disseminated misinformation, amplifying perceptions of risk. repeated media exposure to information about an infectious disease particularly can exacerbate stress responses, amplify worry, and impair functioning. anxiety and uncertainty can drive additional media consumption and further distress, creating a cycle that can be difficult to break. media-fuelled distress can promote behaviours that negatively affect the health-care system (eg, visits to emergency departments and hoarding of face masks), with downstream mental and physical health consequences. the immediate research priority is to better understand the role of repeated media consumption around covid- in amplifying distress and mental ill-health in various groups, and the optimal patterns of consumption to promote wellbeing. research is needed to inform future approaches, including strategies to help individuals to stay informed by authoritative sources, prevent overexposure to media, and mitigate and help manage the effect of viewing images with traumatic content. longer-term research priorities should inform evidencebased guidelines for media around pandemic reporting (eg, clearly identifying authoritative sources, limiting graphic footage, and encouraging social media companies to flag or correct disinformation and rumours). research should also help to develop strategies to mitigate an individual's risk of exposure to misinformation and amplification of anxiety by minimising sharing of misinformation, and promoting strategies for managing the emotional consequences. adaptive and positive uses of traditional media and social media, such as influencers, should be understood and harnessed. understanding the effect of pandemic media on various vulnerable groups is essential. behavioural change-such as the three personal protective behaviours of handwashing, not touching the t-zone of the face, and tissue use, and social or physical distancing required to control the pandemicnecessitates ensuring people know what to do, are motivated to do it, and have the skills and opportunity to enact the changed behaviours. , messaging is key for good knowledge, but public health messaging needs to draw on behavioural science if it is to be effective and avoid unintended consequences. we know that the more concerned people are in pandemics, the more likely they are to adhere to advice. however, increasing concern experienced by the public might heighten distress, which could undermine adherence or exacerbate existing mental health issues. anxiety can be fuelled by uncertainty and by fears of risk of harm to self or others. for example, feelings of paranoia can be heavily influenced by anxiety, and symptoms of obsessive compulsive disorder can be associated with fear of contagion and rigid handwashing. increasing people's confidence and clarity in what they need to do fosters position paper adherence to health behaviours, and can help people to manage psychological distress. immediate research on covid- health messaging is urgently required to both optimise health behaviour change and to reduce unintended mental health issues, which will be required in the event of a second wave of infection. research should prioritise message content, format, and delivery modes and behavioural change alongside risk communication, and consider how this might need to vary for diverse groups. a virtuous cycle that tracks perceptions of and responses to public health messages during this pandemic will enable iterative improvements. it must be informed by mental health science to close the knowledge-to-implementation gap (eg, between effective behaviour messages and maladaptive consequences). longer-term research priorities are to create an evidence base of lessons learned to plan for future pandemics-that is, detailing how to foster a rapid and coordinated response regarding health messaging from governments and simultaneously to develop effective systems embedded in communities to reach out and access the most vulnerable groups in our society, including how to motivate and enable people to prepare psychologically and plan practically for possible future scenarios, and how to promote people's care and concern for others, fostering a sense of collective solidarity and altruism. the optimal messaging should be tailored (including digitally) to different social groups to connect diverse segments of the population to appropriate mental health information resources. almost nothing is known with certainty about the effect of sars-cov- infection on the human nervous system. sars-cov- is a zoonotic virus and a review from suggested that about half of zoonotic virus epidemics have been caused by neurotropic viruses that invade the cns. the closely related coronaviruses responsible for the severe acute respiratory syndrome epidemic in and the so-called middle east respiratory syndrome in are biologically neurotropic and clinically neurotoxic, causing mental health and neurological disorders. [ ] [ ] [ ] sars-cov- has a similar receptor-binding domain structure to sars-cov and probably shares its neurotropism and neurotoxicity (panel ). neurological symptoms of covid- infection are common, diverse, and often severe. in a retrospective study of patients in wuhan, china % had cns symptoms or disorders and the subgroup of patients with severe respiratory disease had significantly increased frequency of cns problems ( %). the problems reported include dizziness, head ache, loss of smell (anosmia), loss of taste (ageusia), muscle pain and weakness, impaired consciousness, and cerebrovascular complications. similar reports have begun to emerge from italy. some of these acute neurological presentations could reflect systemic aspects of infection, such as disseminated intravascular coagulation causing strokes or intense inflammation and hypoxia causing delirium. sars-cov- infection of the brain could be a contributor to the core medical syndrome of respiratory distress and failure in patients with covid- . viral infection of the lung alveoli is the immediate cause of severe acute respiratory syndrome; but viral infection of key brainstem nuclei could disrupt the normal rhythms and homoeostatic control of respiration. this idea needs to be tested rapidly because if brainstem infection does contribute to the severity of sars and the need for treatment in an intensive care unit, it could be directly relevant to the immediate covid- crisis in the nhs and other health-care systems. in the longer term, it is possible that sars-cov- will have persistent direct neurotoxic effects and immunemediated neurotoxic effects on the brain. the spanish flu epidemic of - was linked to a spike in incidence of post-encephalitic parkinsonism. currently, it is not known if sars-cov- infection could cause mental health or neurodegenerative disorders immediately or years after the acute respiratory phase of covid- has passed, but action is needed now to build the research capacity to test these potentially important biological causes of covid- -related mental illness. immediate actions include the development of a neuropsychological database of covid- cases to bring together standardised, longitudinally repeated data at scale both from the clinic for those needing hospital facilities for sars-cov- -infected tissue handling need to be expanded to examine human brain tissue post mortem, which is crucial to understanding the neurotropic and neurotoxic properties of the virus. facilities equipped to safely handle human (or animal) brain tissue infected with sars-cov- are currently very few in number. we recommend building pathology and molecular neuroscience networks to enable brain and other tissue to be collected at autopsy and examined for viral infection and damage. this will require protocols for tissue collection and examination in appropriate laboratory facilities to protect researchers and other staff at all times. the longer-term research priorities are to understand the mechanisms by which sars-cov- might enter the brain. there are two conceivable pathways: neuronal or vascular. the neuronal pathway, used by other coronaviruses, , is to invade a specialist sensory receptor in peripheral tissue, travel by the axonal transport systems to the brainstem, and propagate between neurons by transsynaptic mechanisms. it is not known whether sars-cov- can follow the same path to infect the human brain or whether it invades nerve cells by hijacking angiotensin converting enzyme (ace ), - despite neurons expressing low amounts of the protein, as described in a preprint and two other published studies. , alternatively, sars-cov- might invade the brain from the blood, if circulating particles of the virus were transported across the blood-brain barrier by binding to ace receptors expressed by endothelial cells, or if infected leucocytes could carry the virus with them as they migrate into the tissues as part of the immune response to infection. better understanding of how the intense systemic immune response to sars-cov- infection affects mental health and neurological symptoms, , , and of the mechanisms of immune clearance of sars-cov- , is also needed. , post-infectious fatigue and depressive syndromes have been associated with other epidemics, and it seems possible that the same will be true of the covid- pandemic. longitudinal studies, especially if commenced before or soon after the start of the current pandemic, will be crucial in establishing the often complex biological pathways between infection and mental health outcomes. [ ] [ ] [ ] candidate biomarkers need to be evaluated to measure the effects of sars-cov- infection on the human brain and brainstem in living patients, including structural and functional mri, diffusion-weighted mri, quantitative cerebral blood flow imaging, and magnetic resonance spectroscopy. the tesla mri technique has sufficient spatial resolution to measure functional connectivity between subcortical structures that constitute networks for respiratory control and distress. other methods could include sampling cerebrospinal fluid or use of pet to measure brain inflammation; patient self-reporting or behavioural testing of smell, taste, and other cranial or vagal sensory functions; electrophysiological methods to measure brainstem function; and computerised tests of cognitive and emotional processing. informed by greater understanding of the effects of viral infection on the nervous system and by more accurate biomarkers of brain function in patients with covid- , interventions need to be developed to interrupt or prevent the adverse biological effects of sars-cov- on brain function and mental health. potential drug targets include putative mechanisms for neuronal invasion, interneuronal propagation, and immune clearance of sars-cov- . biological and clinical validation of these or other targets would enable experimental medicine studies or early clinical trials of repurposed drugs. for example, the ace inhibitors already licensed for treatment of hypertension, and a licensed drug for reflux oesophagitis, camostat mesylate, that blocks the serine protease tmprss (which operates with ace to facilitate viral entry into cells) have already been advocated as repurposable drugs. there are many other potential candidates for drug repurposing described in a preprint, which could be a faster route to effective treatment for cns infection than development of entirely new drugs or vaccines. partnerships between researchers in academia and industry will be vital. many of the immediate priorities are for surveillance of general and specific populations for effects of sars-cov- infection on health, ranging from health behaviours, psychological symptoms, neuropsychiatric disorders, and mortality, including, but not limited to, suicide. the other immediate priority is to assemble cohorts to determine longer-term outcomes and provide a resource for nesting intervention studies, and a resource of interventions to monitor their effectiveness. we recommend three main routes. for each of these routes, there is a need to coordinate existing research infrastructure through shared protocols, research measures, and data assets, and to uphold the highest standards of scientific and ethical review. we urge the mental health science community to combine agility in initiating new or adapting existing research with collective scrutiny and collaboration. first, administrative data assets principally derived from existing electronic health records, with systems in place to interrogate these for research purposes, provide a means of identifying health effects at scale. for general hospital settings, which provides near realtime information from health records (eg, to provide feedback on neurological consequences of severe covid- ). these systems should be linked between mental health services, acute medical services, and community health services to identify patterns and trends both in clinical populations and in individuals with confirmed or suspected covid- . second, surveillance through recruitment platforms and existing cohorts has the benefit of embedding research on covid- into studies where participants' mental or cognitive health has previously been ascertained. existing cohorts or data platforms that can be rapidly deployed for covid- research are likely to be particularly valuable. examples include the national institute for health research national bioresource, a platform that already includes clinical and genetic data on participants, and could be deployed for rapid characterisation of mental health and neurological symptoms. uk biobank has successfully done a webbased mental health survey of individuals, and the ongoing neuroimaging studies of individuals with some repeat imaging, provide an ideal opportunity to image the effect of sars-cov- infection on the brain and the brainstem via a before-and-after imaging comparison. third, novel population-based studies on mental health and covid- should be established, using appropriate epidemiologically robust survey methodology for both the whole population and specific groups of particular interest (eg, children and young people, front-line staff in health and social care, and people who have survived severe . priority should be given to assembling representive populations using explicit sampling frames. finally, many other disciplines will be establishing similar studies and it is vital that the ascertainment of mental health should be embedded wherever possible. whether using established or new cohorts, priority should be given to methods that can ascertain covid- status, symptoms, and behaviours in as close to real-time as possible, providing a dynamic picture of change in illness status, social circumstances, and behaviours. questions regarding covid- and mental health symptoms and social stressors can readily be disseminated through smartphones. passive data from smartphones can also give high temporal resolution to behaviours related to the pandemic. cohorts should gain permissions for the linkage of records, including serological status, when mass testing becomes available, and consent for recruitment into nested substudies, including randomised trials of interventions. patient and public involvement in research is a critical underpinning component to research. given that the entire population has lived experience of the covid- pandemic, researchers will need to be particularly mindful of consulting and collaborating with patient and public groups that reflect the diverse groups being studied when developing protocols, conducting research, and interpreting results (panel ). multidisciplinary mental health science research must be central to the international response to the covid- researchers must continue to describe the patient group or population and the research question under study. a priori research questions are crucial. sample size, sources of bias, participant characteristics (including sex, age, and ethnicity), and study design need to be carefully considered and must be appropriate to the research questions. research on human participants should maintain high standards of ethical practice, including seeking research ethics committee approval. committees now have fast-track procedures to expedite study start up. ethical considerations for doing coronavirus disease (covid- )-related research have been published. , vulnerable groups researchers should recognise the capacity of the pandemic to exacerbate health inequalities within populations, particularly affecting people with established mental health issues (including severe mental illnesses) and physical disability. those with precarious or no employment or housing, or other forms of social inequality, such as digital poverty, should also be considered. researchers should continue to engage and involve patients, people with lived experience, the public, and service providers in their work by mutually setting research questions, testing the acceptability of protocols and questionnaires, and interpreting results. researchers should ensure that they discuss their research findings with participants. there is an obvious need for researchers to use and share full study protocols and measures, where possible. this will facilitate comparisons between data and projects. the urgency of the research effort should be a strong driver for the principles of open science, reproducibility, and data sharing. the ready availability of analysis code and data is essential to verifying findings. broad adoption of the registered reports publication model, including rapid peer review of study protocols before data collection, will help to minimise waste and ensure conclusions are empirically sound. the challenge of the covid- pandemic requires imaginative collaborations between disciplines, including, but not limited to, psychology, psychiatry, neuroscience, virology, intensive care medicine, and respiratory medicine. previous experience with epidemics has shown the "essential role that the humanities and social sciences play in information, reduction of fear and stigma, prevention, screening, treatment adherence, and control policies". where possible, research protocols should be deployed at scale harnessing existing research infrastructures, including the clinical research networks, biomedical research centres, mental health translational research collaboration, mq data science group, charities, service user groups, and professional bodies. to avoid waste and protect against participant fatigue, it is essential that there is national coordination across research groups. international collaboration and a global perspective would also be beneficial. pandemic, given the potential effects on individual and population mental health, and its potential effect on the brain function of some of those affected by the disease. there are important immediate insights to be gained, which could provide evidence-based guidance on responding to this pandemic and on how to promote mental health and wellbeing, and safeguard the brain, should future waves of infection emerge (panel ). the research priorities across the social, psychological, and neuroscientific aspects of this pandemic should be coordinated at a national and international level. we urge uk research funding agencies to work with researchers, people with lived experience, and others to establish a high-level coordination group to ensure that the mental health science research priorities are addressed swiftly, and that a firm evidence base is established for long-term studies. we need rigorous, peer-reviewed, ethically approved research codeveloped with people with lived experience that can be translated into effective interventions, rather than the current uncoordinated approach with a plethora of underpowered studies and surveys. the immediate priority is the collection of high-quality data on the mental health and psychological effects of the covid- pandemic across the whole population and in specific vulnerable groups, and on brain function, cognition, and mental health for patients with covid- at all clinical stages of infection and illness. these datasets must be brought together under a national data portal for rapid access and use. there is an urgent need for the discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of this pandemic. this includes bespoke psychological interventions to boost wellbeing and minimise mental health risks across society, including in vulnerable groups, and experimental medicine studies to validate clinical biomarkers and repurpose new treatments for the potentially neurotoxic effects of the virus. there is an urgent need for research to address the effect of repeated pandemic-related media consumption and to optimise health messaging around covid- . rising to this challenge will require integration across disciplines and sectors, including industry and health and social care. new funding will be required to meet these priorities, and it can be efficiently leveraged by the uk's worldleading neuroscience and mental health research infrastructure. the uk must connect with international funders and researchers to support a global response to the mental health and neurological challenges of this pandemic. in these challenging times, mental health science should be harnessed to serve society and benefit both mental and physical health in the long term. eb, eah, mh, rco'c, vhp, it, and sw contributed to the literature review, conceptualisation, design and interpretation of surveys, and writing and editing of the manuscript as part of the core advisory group. cc contributed to and coordinated the writing and editing of the manuscript. kc analysed the qualitative data gathered via the stakeholder survey. la, cb, hc, rcs, ie, tf, aj, im, sm, akp, rs, cmw, and ly contributed to the drafting and formulation of the manuscript as part of the expert advisory group. tk, kk, and as contributed to the drafting and formulation of the manuscript as part of the expert advisory group and by including lived-experience expertise. all authors approved the final version for submission. cb reports grants and personal fees from acadia and lundbeck; personal fees from roche, otsuka, biogen, eli lilly, novo nordisk, aarp, and exciva; and grants from synexus, outside the submitted work. eah reports serving on the board of trustees of the charity mq: transforming mental health and as chair of the research committee, but receives no remuneration for these roles. eah receives royalties from books and occasional fees for workshops and invited addresses; receives occasional consultancy fees from the swedish agency for health technology assessment and assessment of social services; and reports grants from the oak foundation, the lupina foundation, and the swedish research council. rco'c is a member of the national institute of health and care excellence's guideline development group for the management of selfharm; is co-chair of the academic advisory group to the scottish government's national suicide prevention leadership group; receives royalties from books, and occasional fees for workshops and invited addresses; and reports grants from medical research foundation, the mindstep foundation, chief scientist office, medical research council, nhs health scotland, scottish government, and national institute for health research (nihr). kk has received meeting attendance payments from the department of health and social care, nhs england and nhs improvement, and the royal college of psychiatry (rcpsych) over the last year for service user representative work, and payment for a training session she facilitated for rcpsych; and received a pass and accommodation for the rcpsych annual conference in . akp reports financial support from uk taxpayers, the uk's economic and social research council, the british academy, the diana award, the john fell fund, the leverhulme trust, barnardo's uk, and the huo family foundation in the past five years. as part of science communication and policy outreach activities; and served in an unpaid advisory capacity to the organization for economic co-operation and development, facebook, google, and the parentzone. it is a trustee of mq: transforming mental the stakeholder survey was funded by mq: transforming mental health. activity costs for this work, including the ipsos mori survey, were partly supported by a core grant the academy of medical sciences receives annually from the government department for business, energy & industrial strategy for policy, communications and public engagement. the views expressed are the views of the authors alone and do not necessarily represent the views of their organisations or funding sources. adult psychiatric morbidity survey data resource profile: the mental health of children and young people surveys (mhcyp) psychological treatments: a call for mental-health science the academy of medical sciences covid- and mental wellbeing covid- : a living systematic map of the evidence a nationwide survey of psychological distress among chinese people in the covid- epidemic: implications and policy recommendations factors associated with mental health outcomes among health care workers exposed to coronavirus disease immediate psychological responses and associated factors during the initial stage of the 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ethical considerations in responding to the covid- pandemic what's next for registered reports? toward a global health approach: lessons from the hiv and ebola epidemics we are grateful to all staff at the academy of medical sciences and mq: transforming mental health for their work in coordinating and supporting this project's secretariat and communications. special thanks to rachel quinn, nick hillier, helen munn, neil balmer, angeliki yiangou, fern brookes, holly rogers, claire bithell, naomi clarke, melanie etherton, tom livermore, dylan williams, and daisy armitage. we also extend our sincere thanks to katie white, carolin oetzmann, valeria de angel, and sumithra velupillai at king's college london, and norman freshney from norman freshney consulting, for their tremendous efforts in data analysis, and beau gamble at uppsala university and seonaid cleare at university of glasgow for their support with referencing. we are also grateful to the team at ipsos mori for their work on the online omnibus. special thanks also to everyone who participated in the mq: transforming mental health and ipsos mori surveys for sharing their views and personal experiences during challenging times-we are hugely grateful to them for their openness and honesty about mental health and wellbeing. we are grateful to peter jones from the university of cambridge and a member of the mq: transforming mental health board of trustees for comments on an earlier draft. key: cord- -nrc akc authors: zou, xiaojing; li, shusheng; fang, minghao; hu, ming; bian, yi; ling, jianmin; yu, shanshan; jing, liang; li, donghui; huang, jiao title: acute physiology and chronic health evaluation ii score as a predictor of hospital mortality in patients of coronavirus disease date: - - journal: crit care med doi: . /ccm. sha: doc_id: cord_uid: nrc akc objectives: coronavirus disease has emerged as a major global health threat with a great number of deaths in china. we aimed to assess the association between acute physiology and chronic health evaluation ii score and hospital mortality in patients with coronavirus disease , and to compare the predictive ability of acute physiology and chronic health evaluation ii score, with sequential organ failure assessment score and confusion, urea, respiratory rate, blood pressure, age (curb ) score. design: retrospective observational cohort. setting: tongji hospital in wuhan, china. subjects: confirmed patients with coronavirus disease hospitalized in the icu of tongji hospital from january , , to february , . interventions: none. measurements and main results: of potentially eligible patients with symptoms of coronavirus disease , patients ( . %) were diagnosed as suspected cases, and one patient ( . %) suffered from cardiac arrest immediately after admission. ultimately, patients were enrolled in the analysis and patients ( . %) died. mean acute physiology and chronic health evaluation ii score ( . ± . ) was much higher in deaths compared with the mean acute physiology and chronic health evaluation ii score of . ± . in survivors (p < . ). acute physiology and chronic health evaluation ii score was independently associated with hospital mortality (adjusted hazard ratio, . ; % ci, . – . ). in predicting hospital mortality, acute physiology and chronic health evaluation ii score demonstrated better discriminative ability (area under the curve, . ; % ci, . – . ) than sequential organ failure assessment score (area under the curve, . ; % ci, . – . ) and curb score (area under the curve, . ; % ci, . – . ). based on the cut-off value of , acute physiology and chronic health evaluation ii score could predict the death of patients with coronavirus disease with a sensitivity of . % and a specificity of . %. kaplan-meier analysis showed that the survivor probability of patients with coronavirus disease with acute physiology and chronic health evaluation ii score less than was notably higher than that of patients with acute physiology and chronic health evaluation ii score greater than or equal to (p < . ). conclusions: acute physiology and chronic health evaluation ii score was an effective clinical tool to predict hospital mortality in patients with coronavirus disease compared with sequential organ failure assessment score and curb score. acute physiology and chronic health evaluation ii score greater than or equal to serves as an early warning indicator of death and may provide guidance to make further clinical decisions. strated better discriminative ability (area under the curve, . ; % ci, . - . ) than sequential organ failure assessment score (area under the curve, . ; % ci, . - . ) and curb score (area under the curve, . ; % ci, . - . ). based on the cut-off value of , acute physiology and chronic health evaluation ii score could predict the death of patients with coronavirus disease with a sensitivity of . % and a specificity of . %. kaplan-meier analysis showed that the survivor probability of patients with coronavirus disease with acute physiology and chronic health evaluation ii score less than was notably higher than that of patients with acute physiology and chronic health evaluation ii score greater than or equal to (p < . ). conclusions: acute physiology and chronic health evaluation ii score was an effective clinical tool to predict hospital mortality in patients with coronavirus disease compared with sequential organ failure assessment score and curb score. acute physiology and chronic health evaluation ii score greater than or equal to serves as an early warning indicator of death and may provide guidance to make further clinical decisions. (crit care med ; xx: - ) key words: acute physiology and chronic health evaluation ii score; coronavirus disease ; mortality; risk factor; severe acute respiratory syndrome coronavirus i n december , a cluster of acute pneumonia infected with severe acute respiratory syndrome coronavirus (sars-cov- ), now known as coronavirus disease , occurred in wuhan, china ( ) ( ) ( ) . the disease has rapidly spread throughout china and many other countries. a total of , cases and , deaths have been reported in china, whereas , cases and deaths have been reported in countries and regions outside china by february , . the mortality of hospitalized patients was . - % ( , ) . the -day mortality of the critical patients was reported to be . %, which was considerable ( ) . covid- has emerged as a major global health threat; however, no clinical scoring system was reported to identify patients with a potentially unfavorable prognosis quickly. during the clinical practice of patients' treatment, we observed that some patients rapidly deteriorated, developing respiratory failure, acute respiratory distress syndrome (ards), and even multiple organ failure, leading to death. evaluation of various organ functions may predict the mortality of patients with covid- . acute physiology and chronic health evaluation (apache) ii score and sequential organ failure assessment (sofa) score are commonly used to assess disease severity and estimate hospital mortality in general critical illnesses ( , ) . confusion, urea, respiratory rate, blood pressure, age (curb ) score is commonly used to assess the severity and mortality of pneumonia ( ). these scoring system may also be used to assess the mortality of covid- . in this study, we aimed to describe the difference of epidemiologic and clinical characteristics between survivors and deaths, and we attempt to provide an effective clinical tool to predict the probability of death among patients with covid- . this single-center, retrospective study was done at tongji hospital. tongji hospital, located in wuhan, hubei province, the endemic areas of covid- , is one of the major tertiary teaching hospitals and is responsible for the treatments for patients with severe covid- assigned by the government. we recruited inpatients cared in the icu from january , , to february , , who have been diagnosed as covid- , according to world health organization interim guidance ( ) . laboratory confirmation of covid- was performed by the local health authority as previously described ( ) . data of the patients were achieved by reviewing the admission logs and histories from all available electronic medical records and patient care resources. the patients were followed up to february , . this study was approved by the ethics commission of tongji hospital (tj-irb ). data extraction was performed by physicians using a standardized form to collect data about demographic characteristics, exposure history to huanan seafood market, delay time from illness onset to hospitalization, underlying chronic medical conditions, symptoms from onset to admission, vital signs, laboratory finding, complications, and outcomes. the date of disease onset was defined as the day when the symptom was noticed. for all patients, the glasgow coma score (gcs), sofa score, curb score, and apache ii score were assessed within hours of admission. the length of hospitalization and outcome state of each patient were recorded. ards was defined according to the berlin definition ( ) . acute kidney injury was identified according to the kidney disease: improving global outcomes definition. the cardiac injury was defined if the serum levels of cardiac biomarkers (e.g., troponin i) were above the th percentile upper reference limit or new abnormalities were shown in electrocardiography and echocardiography ( ) . based on the clinical implications of laboratory indices, we identified the cut-off value of these indicators to be the upper or lower limits of their normal range. values are presented as mean ± sd or as number and percentage for continuous variables and categorical variables, respectively. the difference of categorical variables between the survivors and deaths groups was compared by chi-square test or fisher exact test when appropriate, whereas continuous variables were compared using student t test. spearman correlation analysis was performed among significant variables in the univariate analysis. univariate and multivariate cox regression analysis was used to explore the effect of apache ii score, sofa score, and curb score on the occurrence of death. taking account of the potential bias, only variables with the absolute value of a correlation coefficient less than . were included in the initial model of multivariate cox regression analysis. receiver operating characteristics (roc) analyses were conducted to evaluate and compare the predictive value of these three scoring systems. the scoring system with largest area under the curve (auc) of roc curve was selected for further analysis. the cut-off value of the selected scoring system was determined based on the maximum youden index. then the patients with covid- were classified into two groups: low risk, less than cut-off point value and high risk, greater than or equal to cut-off point value. kaplan-meier method was used to compare the survival between these two groups with log-rank test. a p value of less than . was considered statistically significant. all analyses were performed with sas . (sas institute, cary, nc) and r project version . . (r project for statistical computing, vienna, austria; http://cran.r-project.org). from january , , to february , , inpatients with symptoms of covid- had been admitted to icu of tongji hospital. of these patients, patients ( . %) were diagnosed as suspected cases and one patient ( . %) suffered from cardiac arrest immediately after admission. therefore, only patients, including survivors and deaths, were enrolled in this study. most of these patients ( . %) were admitted to icu directly, and patients were transferred from other wards. the days stay in the ward before icu admission were . ± . . except for pneumothorax, the occurrence rate of other complications was much higher in the deaths (all p < . ). the duration of hospitalization in deaths and survivors was similar, with . ± . days and . ± . days, respectively (p = . ) ( table ) . laboratory abnormalities at admission were more frequently observed in deaths than in survivors. elevated level of wbc, monocyte, d-dimer, aspartate aminotransferase, total bilirubin, lactate dehydrogenase, creatine kinase, blood urea nitrogen, creatinine, hypersensitive troponin i, and procalcitonin were observed in deaths, when compared with survivors (all p < . ). total bilirubin of greater than μmol/l was documented in seven deaths ( . %) and three survivors ( . %). the neutrophil-to-lymphocyte ratio ( . ± . vs . ± . ; p < . ) and platelet-to-lymphocyte ratio ( . ± . vs . ± . ; p < . ) were higher in deaths than in survivors. the prothrombin time and activated partial thromboplastin time were longer, whereas the levels of platelet and albumin were lower in deaths (all p < . ) ( table ) . a total of patients ( . %) presented bilateral pneumonia, and the other six patients ( . %) showed unilateral pneumonia (table ) . appendix figure in multivariable cox regression analyses, high apache ii score (adjusted hazard ratio [hr], . ; % ci, . - . ) and sofa score (adjusted hr, . ; % ci, . - . ) increased the hospital mortality risk for the patients with covid- ( table ) . roc analyses were used to determine the cut-off value of these three scoring systems in evaluating hospital mortality risk. the auc was . ( % ci, . - . ), . ( % ci, . - . ), and . ( % ci, . - . ) for apache ii, sofa, and curb scores, with the cut-off point value of , , and , respectively. comparing to the other two scoring systems, apache ii score was a better predictor for hospital mortality of covid- , with sensitivity and specificity to be . % and . %, respectively (p < . ) (fig. ) . patients were then divided into two groups based on the cutoff point value of apache ii score: low risk, less than and high risk, greater than or equal to . the median follow-up time since admission was days (range, - d). kaplan-meier analysis showed that the survivor probability of patients with covid- with low risk was significantly higher than that of patients with high risk (p < . ). the median survival time for the patients in high-risk group was days ( % ci, - d) (fig. ) . this is a retrospective study on the epidemiology and clinical characteristics of the patients with covid- . about half of the patients had organ dysfunctions. apache ii score was demonstrated to be independently associated with hospital mortality in patients with covid- . furthermore, apache ii score performed better to predict hospital mortality in patients with covid- compared with sofa and curb scores. apache ii score greater than or equal to serves as an early warning indicator of death, which may help provide guidance to make further clinical decisions. sars-cov- is a coronavirus that can be transmitted to humans like sars-cov and middle eastern respiratory syndrome (mers)-cov, and these viruses are all related to high mortality in patients with critical illness. in a cohort of critical patients with sars in canada, % of patients had died at days ( ) . fifty-eight percentage of patients had died at days in a saudi arabia cohort with patients with mers ( ) . yang et al ( ) reported . % of critically ill patients with covid- had died at days. in our cohort, two thirds of critically ill patients died. the mortality of patients with covid- was higher than that previously seen in critically ill patients with sars and mers. several of the reasons are as follows. first, a large number of covid- cases occurred in a short period of time led to difficulty in hospitalization treatment. in our cohort, the duration from onset to hospitalization was longer in deaths medicine remains inadequate. because of the considerable mortality of patients with covid- , a clinically predictive system for early warning of mortality risk is urgently needed. the cut-off value of apache ii score in covid- is much lower to predict mortality. several reasons may explain it. first, gcs is an important component of apache ii score. direct damage to the nervous system by sars-cov- was rarely reported. only a few patients had a disturbance of consciousness in the study. most of them suffered from hypoxemia-induced ischemic hypoxic encephalopathy and one was attributed to underlying cerebral hemorrhage. second, apache ii score was assessed according to the characteristics of the patients on the first day of icu admission. abnormal levels of serum sodium and potassium were observed in some patients, but only a few patients got scores for the corresponding part in apache ii score. finally, according to our observation, several patients deteriorated during their stay in the hospital in a few days and quickly died. although timely given powerful empirical treatments including glucocorticoid, immunoglobulin, mechanical ventilation, etc, the patients were still hard to recover from covid- . a recent study showed the median apache ii score of survivors and deaths in critically ill patients with covid- were and , respectively ( ) . this indicated that covid- might be more variable and mortal, compared with pneumonia caused by other pathogens. further studies are needed to confirm our findings. apache ii score, sofa score, and curb score are commonly used to describe multiple organ function for assessing disease severity and estimate hospital mortality ( , , ) . according to recent reports, any underlying disorder was significantly more common in severe cases when compared with nonsevere cases. the medical history of coronary heart disease was an independent determinant of critical illness of the patients with covid- ( ) , and it was also associated with a higher risk of mortality in patients with covid- ( ) . in this cohort, about half of patients had one or more underlying comorbidities, and coronary heart disease was more common in deaths than in survivors. it suggested that comorbidities played an important role in the death of the patients with covid- . age has also been identified to be associated with the severity and death in patients with covid- based on the present and previous studies ( ) ( ) ( ) . of the three score systems, only apache ii score includes comorbidities and age, whereas curb score takes into account only age, and sofa score takes into account neither of them. these may explain why apache ii score performed better than the other two for predicting mortality in patients with covid- . notably, sars-cov- mainly caused lung lesions, but other organs injury cannot be neglected. in the present study, we found that the platelet-to-lymphocyte ratio was higher in deaths than that in survivors. qu et al ( ) also demonstrated that high platelet-to-lymphocyte ratio was associated with severe illness in patients with covid- . platelet-to-lymphocyte ratio mainly reflects the level of systemic inflammation, and high value may lead to adverse outcome. recent studies have shown that the proportion of developing liver injury in patients with severe covid- was significantly higher than that in mild patients ( ) ( ) ( ) . our study also found that the proportion of liver dysfunction was higher in the deaths group than that in the survivors group, consistent with the other study ( ) . currently, studies on the mechanisms of sars-cov- -related liver injury are limited. it has been shown that sars-cov- also uses angiotensin converting enzyme as its entry receptor as sars-cov does ( ) . whether it results in liver damage in patients remains to be investigated. troponin i was significantly increased in patients with severe covid- compared with those with milder illness ( ) . the mechanisms may be similar to that of myocardial injury in other severe respiratory illnesses in which myocardial oxygen demand is heightened and inflammation is rampant ( ) . further studies are need to confirm the mechanisms underlying these findings. there were still some limitations in our study. first, the present study was a retrospective, single-center study with a relatively small sample size. second, all patients were enrolled from the icu in tongji hospital. most patients were transferred from other hospitals or isolation units. these patients were more likely to progress to adverse outcomes. therefore, the mortality of patients with covid- in this study may be much higher than general population ( ) and may be not generalized. third, the treatments may influence the outcomes of patients with covid- . but in this study, we aimed to apply the characteristics of the patients at the first day admitted to icu to predict the outcome of the patients with covid- . additional research is needed to understand the role of apache ii score in the risk stratification of patients with covid- . apache ii score was identified to be an effectively clinical tool to predict mortality in patients with covid- compared with sofa score and curb score. future researches are needed to explore whether the application of apache ii score in patients with covid- could reduce mortality and improve patient outcomes. return of the coronavirus: -ncov a new coronavirus associated with human respiratory disease in china china novel coronavirus investigating and research team: a novel coronavirus from patients with pneumonia in china epidemiological and clinical characteristics of cases of novel coronavirus pneumonia in wuhan, 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patients with severe acute respiratory syndrome clinical course and outcomes of critically ill patients with middle east respiratory syndrome coronavirus infection the apache ii score as a predictor of mortality after open heart surgery analysis of myocardial injury in patients with covid- and association between concomitant cardiovascular diseases and severity of covid- clinical characteristics and outcomes of cardiovascular disease patients clinical predictors of mortality due to covid- based on an analysis of data of patients from wuhan, china clinical course and risk factors for mortality of adult inpatients with covid- in wuhan, china: a retrospective cohort study risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease pneumonia in wuhan, china platelet-to-lymphocyte ratio is associated with prognosis in patients with coronavirus disease- comorbidity and its impact on patients with covid- in china: a nationwide analysis covid- in a designated infectious diseases hospital outside hubei province, china liver injury during highly pathogenic human coronavirus infections clinical characteristics of death cases with covid- the novel coronavirus ( -ncov) uses the sars-coronavirus receptor ace and the cellular protease tmprss for entry into target cells sanchis-gomar f: cardiac troponin i in patients with coronavirus disease (covid- ): evidence from a metaanalysis estimating risk for death from novel coronavirus disease, china drs. zou, li, fang, and huang conceived the study idea, analyzed the data, and prepared the article. dr. hu, bian, ling, yu, jing, and li acquired the data and revised the article critically for important intellectual content. all authors contributed to the interpretation of the data and approved the final version of the article.supplemental digital content is available for this article. direct url citations appear in the printed text and are provided in the html and pdf versions of this article on the journal's website (http://journals.lww.com/ ccmjournal).the authors have disclosed that they do not have any potential conflicts of interest.for information regarding this article, e-mail: huangjiao @ .com key: cord- -dcewfkmi authors: zhang, xiao-bo; gui, yong-hao; xu, xiu; zhu, da-qian; zhai, yi-hui; ge, xiao-ling; xu, hong title: response to children’s physical and mental needs during the covid- outbreak date: - - journal: world j pediatr doi: . /s - - - sha: doc_id: cord_uid: dcewfkmi nan school closure and stay-at-home, as a part of non-pharmaceutical interventions (npi), have been implemented in china since february as an effective way to mitigate the spread of the virus during the covid- outbreak. as concerns rose over the potential impacts of such npi measures on children's health, such as longer exposure to digital screens, irregular sleep pattern, weight gain, and loss of cardiorespiratory fitness [ ] , the chinese government, experts on public health, educators on school health, and teachers have been making joint and massive efforts to provide distance learning with well-organized online courses to help. children's hospital of fudan university is the designated hospital for treating pediatric cases with covid- in shanghai. as child healthcare providers at the hospital, such concerns caught our attention and we also paid close attention to potential psychological impacts on children, especially those who have suffered from the infection or from other underlying conditions [ ] . thus far, there are no specific medications for covid- . the ways that have been proven to be most effective at curbing the virus spread are traditional approaches, such as case isolation, social distancing, and school closure [ ] . as child healthcare providers, what can we do when unintended, negative impacts of these approaches are sustained by children? how can we use today's new concepts and advanced technologies to protect children and to put into practice that children are prioritized in the society, while ensuring the principles of gender equity and geographic distribution? how can we cooperate with experts on public health and with educators on school health to perform health communication and to minimize the impact of the pandemic on children's physical and mental health? in the context of such a crisis, as the national children's medical center, we launched a special project, the child health initiative for children and adolescents (chi) (https ://erke-he. tin gyi.com/home/index ), to provide multidisciplinary support and services on physical and mental health, to perform health communication, and to relieve anxiety and stress. it is an internet-based interactive platform for children and adolescents that is intended to improve their overall well-being during the covid- pandemic. the platform includes different dimensions, such as disease prevention and treatment, child health communication and science popularization, improvement of children's mental health, and increment of family and community cohesion. experts which are served on this platform include pediatricians, nurses, pharmacists, social workers, musicians, artists, and educators on school health, as a joint team to provide health service. the free online medical consultant is a popular part of the project that has been started since february . more than doctors specialized in child health care from diversified specialties, including pediatric psychiatry, have been serving online in turn for hours on a daily basis, from am to pm. questions from provinces, municipalities, and autonomous regions in china have been submitted to the platform within the first month of operation. answers were always given promptly online-within minutes in the first week of service. by collecting queries from children and their families, professionals also could spot their needs and thus adjust emergency policies of the hospital and the society as a whole in response. the free online live webcast is another program sought after by users in the project. experts elaborated on selected topics around children's wellbeing during the live webcast. utilizing advanced internet and cloud technology, the platform can support multiple live webcasts simultaneously. one live webcast on march hosted by experts from various specialized fields attracted nearly , online visits within hours. realtime medical consulting by texting were provided during the -hour live webcast to answer questions from the viewers, and frequently asked questions were answered orally and directly. in addition, the platform is keeping updated the latest covid- pandemic information for helping to relieve anxiety and stress in children and parents. it also informs users of child health management, healthy physical growth, and mental health improvement in various forms, such as text, pictures, videos, audiobooks, and webinars. what's more, it takes advantage of music for soothing emotions, art classes to reduce children's feeling of boredom when being kept to stay home, and tailor-made videos to guide physical activities at home. for those who suffer from anxiety and stress, professional assessment tools are also available on the platform. the chi project is currently operating smoothly and has received positive user feedbacks. preliminary online surveys from children and parents have shown that the platform meets their requirements and medical support is the top priority of the service. to make the project live up to its full potential, we plan to expand the assessment of users' needs, to perform thorough user analysis, to prepare better online educational materials and to further evaluate effects, making sure that all such steps abide by the standard health communication process and thus enlarge the positive impact of the project. we are exploring a system and structure that allow medical institutions to join hands with various social sectors by playing up their respective resources and advantages to launch health communication to users. this system may provide insights and experience for the future establishment of health communication channels to the general public under emergent public health conditions. as the global pandemic of covid- continues, a growing number of countries/territories/areas have enforced school closure, with a serious impact on over . billion students globally [ ] . we believe global cooperation is the real cure to the covid- pandemic. we are keen on looking forward to global collaboration, and we hope the model of active involvement of medical institutions in health communication and promotion can have a long-term effect. author contributions zxb designed the program, revised the paper critically for important intellectual content, and final approval of the version to be published; gyh: designed the program, revised the paper critically for important intellectual content, and final approval of the version to be published; xx designed the program, revised the paper critically for important intellectual content, and final approval of the version to be published; zdq designed the program, revised the paper critically for important intellectual content, and final approval of the version to be published; zyh designed the program, revised the paper critically for important intellectual content, and final approval of the version to be published; gxl designed the program, revised the paper critically for important intellectual content, and final approval of the version to be published; xh designed the program, revised the paper critically for important intellectual content, and final approval of the version to be published. ethical approval the study was approved by the ethical committee of children's hospital of fudan university ( - ). understanding differences between summer vs. school obesogenic behaviors of children: the structured days hypothesis the psychological impact of quarantine and how to reduce it: rapid review of the evidence impact of non-pharmaceutical interventions (npis) to reduce covid- mortality and healthcare demand. imperial college covid- response team billion students now home as covid- school closures expand, ministers scale up multimedia approaches to ensure learning continuity the authors declare that they have no competing interests. key: cord- -b phq e authors: alonso tabares, diego title: an airport operations proposal for a pandemic-free air travel date: - - journal: j air transp manag doi: . /j.jairtraman. . sha: doc_id: cord_uid: b phq e the aviation industry needs to work on the resilience of air travel against health threats and regain passenger trust. this paper proposes a pandemic-free travel concept based on creating an infectious diseases free zone in the airport terminal building through screening of passengers, crews and airport workers. this research shows that infectious disease detection methods applicable at the airport could be available in a short timeframe, at affordable cost and in scale. the potential location of passenger health screening, facilitation requirements, health responsibilities delegation and appropriate usage of industry standards for regulations are key elements to a potential implementation that would be phased and long term. the impact of the covid- disease on air travel has been dramatic, making it the worst aviation crisis ever (icao, a) . the perspectives for recovery of air travel are bleak, with an estimated return to the traffic level to take to years (iata, a) . the international civil aviation organization (icao) was created in , in article of its convention stated: "each contracting state agrees to take effective measures to prevent the spread by means of air navigation of cholera, typhus (epidemic), smallpox, yellow fever, plague, and such other communicable diseases …" (icao, ) . this intent was reinforced in the icao general assembly, urging all states to join and participate in the cooperative arrangement for the prevention of spread of communicable disease through air travel (capsca) (icao, ) . just looking at the st century, prior to covid- , the occurrences of pandemics has been frequent: south asian respiratory syndrome (sars, (sars, - , swine flu ( ) ( ) , middle east respiratory syndrome ( ), ebola ( ebola ( - and zika virus ( zika virus ( - . all these health crises had a much lesser impact than the covid- . further to sars, the world health organisation (who) revised the international health regulations (ihr) in providing a legal framework "to prevent, protect against, control and provide a public health response to the international spread of disease …" (who, ) . there has been some research on the methods and screening strategies during a pandemic (gaber et al, ; gold, ) . however, these outbreaks represented some early warnings that have not been fully acknowledged worldwide. for example, still in in the u.s.a., a comprehensive national plan for air travel and communicable disease was not yet ready (u.s. governmental accountability office, ). one of the reasons for air travel to be the safest transport means is to learn from past events. as an industry, resilience of air travel needs continuous improvement. first, preparing to restart and recover aviation to normal traffic levels; then, being ready for the next health crisis and secure passenger confidence in air travel (iata, b) . the first objective for aviation remains to reach the highest possible safety level. the who defines infectious diseases as diseases "caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi; the diseases can be spread, directly or indirectly, from one person to another." (who, a) . the scope in this paper for infectious disease is related to any high contagious and life-threatening disease. pandemic-free air travel will be reached when the following cases for an infectious disease are both reduced to a minimum reasonably practicable risk: -contamination between individuals (passenger, crews and workers at the airport) during the travel journey. -transport of infected persons to different parts of the world. the objective of this paper is to demonstrate what could be done at the airport to continue air travel while reducing the risk of communicable diseases to a minimum. this would result in having the whole air travel free of pandemics and lead to a more resilient air travel industry. this paper is organised as follows: the topic is introduced in chapter (this section), then the current status is described in chapter ; the proposed solutions are discussed in chapter with the analysis of the steps to take in chapter . finally, the conclusions are presented in chapter . world passenger traffic dropped by − . % in april compared to the previous year. "aviation has been shut down" (icao, a (icao, - b impacting travelers and economies as never seen before. the global lockdown and travel restrictions have limited flying to critical air cargo transport for several months. as of july , there are still many countries that have full travel bans or impose quarantine on arrival passengers and only less than ten countries have no travel restrictions (iata, c) . covid- is caused by sars-cov- (severe acute respiratory syndrome coronavirus- ), a newly discovered virus from the coronavirus family. the clinical picture of covid- is highly variable. most commonly observed symptoms include fever, cough and shortness of breath. in the majority of cases the symptoms seem to be mild or are not even recognized. (cdc, a) . based on existing literature the incubation period (the time from exposure to development of symptoms) ranges from to days, with most of the cases being - days. the infectious period (the time when the disease can be spread) ranges - days, but starts - days before symptoms appear. this greatly contributes to the uncontrolled spread, since virus carriers are often still active and not aware of carrying the virus (lau e.h.y et al., ; lessler j. et al., ) . it is assumed that the virus spread is mainly through person-to-person contact via respiratory droplets and aerosols, when they are in close proximity to others in poorly ventilated areas for prolonged periods of time. the probability of smear infection, via surfaces contact, is considered to be negligible in most of the cases (goldman, ) . the companies working at the airport terminal building premises (airports, airlines, ground handlers, national agencies, subcontracted personnel, retailers …) are implementing the following measures to continue or resume operations (aci-europe, ; changi airport, ; u.s. department of transportation, ), to prevent the spread of covid- : -cleaning and sanitizing: enhancing sanitation of floors, carpets, high-contact areas … also, providing hand sanitizers and wipes for facility users. -information: communicating in advance the right information via their website andapplication, with posters, videos and audio announcements on site. -process adaptation: promoting self-servicing, electronic ticketing and touchless kiosks for all airport processes (check-in, bag-drop, immigration, boarding gate ….). limiting the number of people at the terminal to only passengers, with no companions. changing the security check to avoid pat-down and secondary search; adapting customs and immigration controls to avoid any document exchange. -protecting employees working at the airport: use of polycarbonate partition wall panels to separate staff from passengers. -social distancing (varying from to m): using floor markers to materialize queues and waiting points, queue management, seat arrangement, controlling flows, avoiding crowding and using available equipment accordingly (e.g. by assigning to a baggage carousel only one flight, and using only one out of two available). -aircraft boarding and deplaning procedures: smaller groups with more sequencing, more shuttle buses if aircraft in remote stand, limitations to hand luggage on aircraft … -terminal heating, ventilation and air conditioning: increasing the ratio of fresh air, minimizing air recirculation and changing filters regularly. -wearing face masks: encouraged to everybody within the airport premises. mandatory when imposed by the airport home country in public places or means of transport (aena, ). it is to be noted that many of these measures are only feasible with a very low traffic level. specifically, social distancing related measures with pre-covid- traffic levels are not possible as the airports do not have enough surface to implement them. self-service and increased information availability at airports were a trend already present that will continue and increase (aci, b). enhanced cleaning standards, touchless journey and less physical interaction between passengers and airport employees are most likely staying for the long term as well. in principle, the remaining measures against covid- are of interim nature, waiting for availability of a safe vaccine, effective treatment, herd immunity or virus disappearance to happen. there has been the intent for covid- detection with the use of passenger temperature checks and the collection of passenger health self-declaration forms both on departure and on arrivals (paris airports, ). sometimes it has also been combined with a visual inspection. however, given the available scientific evidence, the european aviation safety agency (easa) and european centre for disease control (ecdc) state "that entry screening using temperature control is a high-cost, low-efficiency measure" and "ecdc does not support the widespread implementation of exit or entry screening" [based on temperature checks] (easa, ; ecdc, ). health self-declaration is only effective based on the good faith of passengers and acts more as a deterrent to travel for risk passengers. as such, it is prompt to fraud despite any potential sanctions and a huge challenge to trace back any contagions (ecdc, ). in addition, for most of the individuals their symptoms are mild or not even recognized, but they can still spread the virus. even a person that will develop symptoms has a window of up to days where can present no symptoms and still be infectious (lau e.h.y et al., ; lessler j. et al., ) . as of july , there have been several airports where polymerase chain reaction (pcr) tests have been used to detect infected passengers or airport workers, see table (alaska department of transportation and public facilities, ; port authority ny nj, ; frankfurt airport, ; munich airport, ; sheremetyevo airport, ; iceland directorate of health, ; vienna airport, ; paris airport, ; hong kong airport, ). these pcr tests need a human body fluid sample extraction (swab from nose or throat) and generally while waiting for the result, isolation or quarantine measures are requested. the main purpose of these tests is to offer an alternative for the two weeks quarantine to arrival passengers. most airports have limited pcr testing capacity (around tests per day as quoted for jfk and for frankfurt). pcr tests are also intended to be deployed progressively to main international german and french airports (associated press, ); in the short term, other airports around the world will be adding this capability (brussels, amsterdam, istanbul, san francisco …) the proposed pandemic-free airport concept is similar to the measures put in place for airport security. this concept consists in filtering out infected passengers, crew and workers before they enter the sterile airport zone. a multi-layered risk-management approach is used together with aviation safety management system principles to achieve this aim. comparing this major sanitary covid- crisis with the september th security crisis, some lessons can be learnt: -passengers will not understand different kinds of measures and requirements at different parts of the world if not properly coordinated and communicated. a holistic and accepted worldwide approach for the whole aviation industry is absolutely needed. -the lead time for deployment of permanent measures is very long (e. g. % hold bag screening did not happen before ). permanent measures need to be defined and agreed as quickly as possible at the highest international level. -similar crisis seem to appear (e.g. for liquids and gels threats for security). as seen in chapter , the historical average in this century is one international health crisis every four to five years. more outbreaks are to be expected. the industry needs to be better prepared and not stop all activity once the current crisis is under control. -deployment of costly passenger facilitation measures will be limited. for example, the majority of airport security checks still require the removal of laptops and liquids from the hand luggage because of the cost of the required scanners. -measures need to be in line with the actual risk level to avoid an unnecessary burden on the passenger. a modular and adaptable approach depending on the threat level is needed. the icao public health corridor (phc) (icao, c- d) is a good basis to address the covid- crisis globally based on risk management. the icao phc defines the conditions for healthy travel between two airports. this principle may be key to allow continuation of flying when the next infectious disease threat arrives: the icao phc creates a framework and responsibilities (see fig. ) for the crew, aircraft, airport facilities, passenger and cargo with guidelines on how to achieve a covid- free status. it also provides the forms to report on the status for each party and a certification for achieved standards with an allocated responsibility to make the audits. all guidelines, forms and certifications should be valid and applicable worldwide. an example of the implementation of the phc for the airport facilities is the airports council international (aci) health accreditation program (aci, a). however, the icao phc does not specifically address the health risk related to the employees working at the airport: airline ground staff, ground handlers, retailers, police & immigration officers, cleaning and facility maintenance. this population accounts for a significant amount of the public that transit the airport terminal. these airport workers should also be addressed. the passenger's companions at the airport but not taking a plane (i.e. meeters and greeters) are not considered either. similarly, for the airport's supplies: inputs (e.g. duty-free goods, food …) and outputs (e.g. waste) would need to be added to complete this icao phc framework. disinfection of airport facilities (aci-europe, ), cargo and aircraft (airbus, a; boeing, ) is relatively easily achievable from both technical and operational perspectives. for other items like food supplies and catering, standards exist and are already applied. in order to ensure that a part of the terminal building remains an infectious disease-free zone, a filtering process is required for any person entering. this health screening should not be considered as a medical check, but needs nevertheless to be based on international standards and on medical evidence. the main difficulty with health screening is to accurately detect and filter out infectious people (i.e. passengers, crew or airport workers infected and who can infect other persons). to be able to detect an infectious but asymptomatic individual, while ensuring symptoms that are not caused by an infectious disease can be distinguished. it should not be a requirement that only perfectly healthy persons can fly. there are several methods and techniques currently used or researched for covid- detection for air travel. iata has issued a position paper on covid- testing (iata, d). some of these methods were previously used for the detection of other infectious diseases or for explosives. the major research effort for covid- may be generalized to cover also other future infectious diseases. each infectious disease has its particular characteristics (e.g. incubation period) and associated symptoms in humans. the symptoms can be correlated to the originating disease. this 'symptoms fingerprint' can be used for comparison with the test results. even for new or mutated viruses, the timespan between their appearance and their characterization of the symptoms can be only a matter of weeks (zhou p et al., ; zhu n et al., ) . a non-exhaustive list of detection techniques, there are constantly new developments, is proposed in table . this list is sorted from worse to better according to the level of intrusiveness for the person tested: the benchmark for covid- detection are the pcr tests, as seen in table , based on nasal or throat swabs used to identify infected individuals. serologic tests are used to detect the presence of antibodies, but they are not useful to diagnose an active infection (cdc, b). there are developments to use saliva for the pcr tests (covidtracker, ; skillcell-alcen, ). research in ongoing using spectrography on saliva (reuters, a ) and on the breath chemical composition, using a device similar to a breathalyzer (bioworld, ). for non-intrusive tests, the analysis of respiratory sounds when breathing looks for cough and shortness of breath markers (voice study, ). air sniffers can be used by dogs (dw, ; uk government, ), an electronic nose (airbus, b) or air samplers (; pathsensors, ) . there is also a potential usage of sensors for a non-invasive skin scan to detect possible symptoms (israel c, ). there has been great advance in the development of these techniques and associated logistics for an airport site. testing requires not only test material but also trained personnel to perform them. the pcr testing (see table ) can be taken as an example. the time to get results was first measured in days. mainly due to the capacity of the laboratories to treat the samples, and the time to transport the samples from the airport to the main laboratory. then, the time is reduced to hours with the higher capacity in the laboratories and is currently just one hour in moscow (sheremetyevo airport, ) where samples are treated on site with a point-of-care device. for some of the other tests means described, test results are claimed to take one minute (bioworld, ) or even instantly (reuters, a) . several of the previously mentioned detection systems are already in operation (e.g. pcr), some are undergoing clinical trials while others are still in the research phase. with all the covid- research efforts ongoing, it can be expected that some of the methods still in development may be ready for a proof of concept stage in an airport by the end of . not all of them will reach the operational phase, but there should be enough choice and competition to set up an appropriate health screening method. it is assumed that economies of scale will apply to meet foreseeable high demand. the cost per test is expected to reach an affordable price level in the order of euros and be available for production at massive scale. there are already companies (reuters, a) claiming costs of less than one euro per test. important to note that the information provided for the methods in this section do not cover the medical validation status. any testing, even non-intrusive tests, will need to go through validation by a health agency or research institute prior to starting actual operations in an airport. the detection systems installed at the airport will be based on hardware and software. as stated before, it should be easy to upgrade the software once a new disease appears (or an existing one mutates). the installed hardware in the airport facilities should not require changes to keep the costs of upgrades low. the use of artificial intelligence has a great potential in this field as well. most of the non-intrusive tests listed above, could be configured to analyse a continuous flow of passengers while walking freely or queuing. additionally, their typical time for measuring and processing the information for detection is in seconds. by contrast, intrusive tests require a specific point of control to be set-up with the associated trained personnel as they need a body fluid sample. taking into account all previous considerations, it is assumed that several systems will be available in the near future for covid- detection. and these systems may be generalized for other existing and future communicable diseases. the locations where the passengers could be health screened will depend on the type of detection system, airport layout, operational constraints, local and legal requirements and responsibilities sharing between the different airport stakeholders. testing could be done at dedicated locations in the airport or integrated in existing processes (e.g. security check). there is also the possibility to make this screening in a continuum during several segments of the whole passenger journey. this journey can be split in different processes as depicted in fig. , where potential locations are indicated: for a passenger, the potential health screening location options at specific airport process locations are depending on the passenger flow types: -departure flow: when entering the airport terminal building, at the security check, prior to aircraft boarding (for specific flights). -arrival flow: just after deplaning the aircraft before mixing with other arriving passengers (typically for high risks flights), prior to border control for all incoming flights depending on arrival country policy and its quarantine rules. -transit and transfer flow: combination of the two previous flows depending on the airport set-up. o spectrography -body temperature measurement (by handheld thermometers) -respiratory and heart rate -respiratory sounds -air sniffers -body temperature measurement (by thermographic cameras) -skin scans -off-airport: on a medical facility, able to issue a certificate that is recognized by the travel stakeholders in the countries to be visited. a dedicated flow within the terminal building, similar to trusted passengers' schemes at some airports, could be established where there may still be some lighter controls. this could be valid for departure and arrival flows. possible locations for a distributed health screening in the airport are all zones where passengers walk freely or queue (e.g. boarding gate, immigration and customs control). generally, the more upstream in the passenger flow this health screening is carried out the better. the earlier contagious passengers are filtered out, the sooner the other passengers can be relieved from healthrelated measures applicable to all the population like wearing face masks. it is to be noted that departure health screening is for infectious disease contamination prevention, whereas health screening at arrivals are considered as mitigation means (i.e. if the origin airport is not following the infectious disease detection health screening). airport workers (both landside and airside, before and after security check respectively), need to be tested at regular intervals (e.g. every other day). the intervals will depend on the pandemic risk status and degree of contact workers may have with passengers and other airport public. they may be tested at the same health screenings used for passengers or in dedicated facilities. the airport worker health screening is different from its equivalent in security, where the person needs to go through a security check each time they go airside. the security status changes at every passage to the landside and this could occur several times a day. however, the health status of a worker will not change several times per day. in the case of aircraft crews, they already follow a dedicated flow in the airport. therefore, a customized screening could be established depending on the risk status of the flights and the pandemic status. the airport operations facilitation requirements for the passenger health screening proposed could be summarized as: -process time, including time for results: for individual tests less than a minute when starting operations, but less than thirty seconds would be required in steady mode. -user experience: non-intrusive tests are definitely preferred over swabs from the throat or blood samples. -process automation: a very high-test capacity is needed to handle the passenger flow on airports. manual systems will quickly become prohibitive due to the number of trained personnel required. furthermore, automation avoids any health risks for staff and facilitates the passenger flow. -false negatives: to have somebody infected passing the test. this parameter is critical to restore passenger confidence. a very high-test sensitivity, greater than % is required. -false positives: to have somebody not infected declared infected by the test. this person would need to undergo a second round of tests, which would be an operational burden. therefore, a specificity greater than % would be required. each testing method has its limitations, so from an operational point of view, multiple detection layers may be needed, preferably based on different technologies and symptoms. without entering statistical analysis and just for illustration: if each layer would be % effective for one of the intended parameters to filter the cases, then one layer would provide % protection, two layers % and three layers %. etihad is applying such a multilayer approach in abu dhabi airport, where temperature check, heart and respiratory rate are combined (etihad, a) . the example below presents some rough numbers for a major terminal building at a large hub airport ( million passenger per year): -passengers: assumed , per day ( % departure, % arrival, % transfer). this would mean: o , originating departure passengers, that would need to be tested on the airport premises. alternatively, check these passengers carry a document that certifies they are not infected according to some rules (e.g. pcr test hours old maximum prior to departure). o , arriving passengers as final destination. testing will depend on the risk level at the country of origin or transfer. several cases may be considered: • passengers tested at departure airports in low risk areas do not need to be retested. some random checks could be carried out to audit the checks done previously. • passengers tested at high risk areas could be retested if in doubt of the previous checks or to further reduce the risk. • passengers not tested need to be checked. o , transfer passengers: if these would have been tested on departure and this information would be shared and known for the hub airport during transit, then no test would be needed. otherwise, depending on the risk for each incoming flight (origin), testing policy will need to be defined compounded with the operational constraints already hard enough for transferring passengers at an airport. -airport-based employees: around , having an airside badge, out of the , employees. -airline crews: about , that will start or finish their shift at the airport every day. these numbers clearly illustrate the operational challenge for a health screening on the airport. tests systems should also be scalable to the passenger flow as this flow will vary over time. a further complication lies in the sharing of tests results from one airport to another. generally (except in the u.s.a. and some other terminals) the airport terminal and the airlines operating there are different entities and the airport will not know the passenger and its health results. the responsibility for risk management of a communicable disease at an airport is with the "competent authority". article of the ihr (who, ) , ratified by most countries, describes the attributions of the competent authority, but does not define who this competent authority is. depending on the country, this responsibility is managed by the ministry of health, the ministry of transport or their equivalents. in some countries the local government is responsible and there are occasions when this responsibility is not clear (see miami herald, ) . in fact, besides the technical aspects, the most difficult part to implement a detection system could be to manage the health responsibility within the airport. the health screening, as described in this research, should not be considered as a medical check, but rather as a pre-screening or filtering of individuals within a group. the strict minimum needed to have it running on an airport would be to have the nihil obstat from medical authorities stating that the test and procedures in place are not harmful for the public and workers. as stated above, the airport has no responsibility or legal authority on the health screenings on its premises. the only entities that can currently perform these checks are: -the airline, on the basis of the captain's authority to refuse aircraft boarding to a passenger. for example: frontier (the washington post, ) and air canada (air canada, ) are doing temperature checks to passengers prior to boarding. -the border police,immigration or the competent public health authority, on the basis of giving permission to access the country. currently happening in most of the countries worldwide (iata, c; reuters, b) an airport today, even if it would detect a suspicious passenger, would not necessarily know what to do with the individual, other than to hand the passenger over to the local health authorities. these local health authorities have to be present physically in the airport and have enough resources to handle these events, which is currently not the case. furthermore, the passenger may refuse the test results and oppose the decision. then, a case similar to unruly passenger may appear where the airline would need to take the responsibility. therefore, from a pragmatic point of view, a delegation of authority (but keeping the oversight) from the local health authority towards the airport, the airline or other government agency already present at the airport may be required. this arrangement could be similar to the security check: the staff are not from the police (or equivalent), but the police supervise the check configuration, staff training and have the oversight of the whole set-up. likewise, a clear protocol needs to be established in order to know what to do with a passenger with a positive test result (true or false). this passenger may miss the flight with the associated operational and economic impact. the passenger may ask for compensation, even going through legal claims. this is most likely an unchartered territory today. for the airport, this could become a serious reputational issue as it will suffer all the consequences but with no or very limited responsibility or capacity to act on them. how to make an effective delegation of authority to the airport or to federal agents already at the airport is a topic of intense lobby and discussion. it can be seen in official statements from u.s.a. airlines and airports associations (airlines for aci-north america, ) pushing to have federal government agents, in this case tsa at the security checks, making temperature control with the associated material resources and training. another important topic to be considered regarding responsibility is privacy. specifically for european general data protection regulation, health insurance portability and accountability act or equivalent, that would put a lot of constraints on the use and storage of data. regarding the financing of these health screening measures, article of the ihr (who, ) requires that no charge shall be made by any state when the measures are for the protection of public health. when the measures are for the benefit of the traveller a charge may exist and shall not exceed the cost of the service. depending on the infectious diseases considered, they may be treated as a public health issue or for the benefit of the traveller. there has been an effort by some airlines to cover the potential cost of any covid- related disruption with an insurance (emirates, a) . at the end, the final funding source used for any cost related to health screening measures would be the passenger via the airline ticket with a "health screening charge". this charge may contribute partially or totally to the cost depending on the assessment by the state. this airline ticket fee would be similar to the passenger facilitation or security charge used today (gillen and morrison, ) . the implementation of a pandemic-free airport concept as described in this document will be based on the on the development of several streams that are interconnected: -technical advances on infectious detection means. the various methods need to continue their development, including medical validation and trials in an airport environment. as stated in the previous chapter, several detection methods may need to be combined to reach a screening with the required performance and automation is a must to meet airport facilitation requirements. -testing to mitigate or replace quarantines. the removal of quarantines is absolutely mandatory to go back from our current fragmented world to the connected world we used to live in. quarantines are a deterrent to fly, being de facto an equivalent to a travel ban (iata, e). furthermore, during this crisis, quarantines have been used sometimes erratically without sound justification (reuters, c) . with the detection technologies available in the st century, it is expected that health screening can satisfactory replace quarantine measures. this is the case in the united arab emirates, where a pcr negative test for covid- is required for all departing, arriving or transiting passengers (emirates, b; etihad, b) . except for the scale, historically this is nothing new as some countries request health certificates (e.g. for hiv/aids) or proof of vaccination (e.g. for yellow fever) (who, b). -build of appropriate industry standards and state regulations icao with the capsca subgroup are working to set-up the basic guidelines and protocol for health screening as mitigation for quarantine. once completed, these will deliver the basis on which states can build their legislation. the use of industry standards for process, methods and information exchanges is key for a wide adoption. these standards can be used as building bricks for states regulation. it is also a way to ease the start-up of regulations, their subsequent updates and mutual recognition between different states. the additional effort to generalize these regulations for future infectious diseases would be low if done at the same time with covid- related updates. -adequate health screening responsibility management as seen in section . . , the implementation of health screening at the airport will require local health authorities to scale up resources at the airport or delegate to the airport, airline or other government agency already present. -public opinion demand and support the covid- shock will result in a worldwide, public demand for more stringent control of communicable diseases, specifically for air travel. this may replicate at a political level which would then lead to new health-related regulations impacting air travel. it is very likely that health aspects may need to be considered from now on by the aviation ecosystem and this may include airport health screening and permanent presence of health personnel at the airport. success of the proposed concept would support public opinion being confident in air travel again, keep aviation as the safest and also healthiest travel means and prepare for future pandemics. -backing of the air travel industry there are many stakeholders in the air travel industry worldwide. the alignment of the diverse interests to support the proposed concept will be another challenge. health screening facilities at a given airport could be seen as a competitive advantage that may evolve into a pandemic-free airport network that would impact airline network and travel demand in general. finally, it can be anticipated that the complete process will be lengthy, as the typical time to set up and implement will be measured in years. a tentative roadmap on how the steps to this implementation could happen is presented: -within the airport: it may start from a specific zone in the terminal with a trial on a route (emirates, c) . then, it will grow to cover the boarding gate and later a dedicated zone within the terminal building with several gates, for some intercontinental traffic routes. afterwards, generalization for intercontinental and international traffic. when interest on this implementation reaches domestic flights, the zone could go from boarding gate up to the multi-purpose security and health check in the terminal. -between airports: it may start like some bubbles with just a few airports. when starting to connect between them a safe corridor will be established (see aviation week, ). the international selected airports may be triggered by the nomination by the state of their designated points of entry. if successful, these corridors may cover a geographical and political zone (e.g. schengen countries). each geographical zone will set-up their own common ground, maybe with different levels of testing that need to be coherent with the others to connect seamlessly. and slowly, hopefully, one day the world will be connected pandemic-free. the air travel industry is currently fighting to overcome the effects of the covid- crisis. it may take several years, but the industry will recover. however, surviving this crisis is not enough. the aviation industry needs to take action to be prepared for a similar future health crisis. air travel needs to be resilient to these health threats to avoid a repetition of a complete traffic standstill. pandemic-free air travel requires a pandemic-free airport. the infectious disease detection capability is the key to this end. there are sound prospects that technology will be able to deliver this capability at an affordable cost and in scale in a not so distant future. the available technology will be the enabler to trigger the responsibility discussion about the health screening. certainly, that would mean that if departure passengers can be health screened at the airport or they have been screened off-airport appropriately, the exceptional measures as the passenger advance in the journey process and through the different filters can be lifted (e.g. social distancing requirements, wearing face coverings and quarantines). pandemic-free travel based on a pandemic-free airport, has been sketched in this document as a tool to achieve air travel resilience to health threats. its success will depend on technical advances on infectious detection means, acceptance to replace quarantines by testing, build of appropriate industry standards and state regulations, adequate health screening responsibility management, public opinion and support by all the air travel stakeholders. adoption would be progressive from within one airport, to airport corridors and finally worldwide. historically, air travel has always been focused on safety. from the 's, and continuing today, security threats had to be dealt with as well. the covid- crisis has shown us that from now on, health will be another key aspect to take into account. safety, security and health will be the new triad for air travel. the aviation industry can and must be prepared to avoid quarantines and travel bans when future pandemics occur. the potential benefits of being well prepared outnumber the obstacles to be overcome. no confidential data has been used for this article. diego alonso tabares: conceptualization, writing, reviewing, editing, visualization. none. the article represents exclusively the personal opinion of the author and does not intend to represent his employer's position or any of his affiliations. aci airport health accreditation programme guidelines for a healthy passenger experience at airports policy positions on facial coverings & passenger health screening related to covid- health-alert: coronavirus covid- outbreak air canada cleancare+ program introduces new personal safety and sanitary measures to give customers added assurance keep trust in air travel embark on disruptive biotechnology solutions for aviation security operations airlines endorse temperature 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will ask voters: should airport screen all travelers for covid- symptoms pathsensors technology overview xprescheck pilot program for airport employees opens at jfk international airport's terminal ; the first in-airport covid- testing location in the us israeli hospital trials super-quick saliva test for covid- canada to mandate temperature checks for airline passengers, trudeau says uk quarantines travellers from spain in sudden blow to europe's revival express-test covid- : the results in just minutes easycov: covid- salivary rapid molecular test frontier just became the first us airline to require passenger temperature screening covid- detection dogs trial launches runway to recovery air travel and communicable diseasescomprehensive federal plan needed for u.s. aviation system's preparedness voice study, . covid- voice study international health regulations who, a. infectious diseases travel advice -vaccines a pneumonia outbreak associated with a new coronavirus of probable bat origin a novel coronavirus from patients with pneumonia in china this research did not receive any specific grant from funding agencies in the public, commercial or not for profit sectors. supplementary data to this article can be found online at https://doi. org/ . /j.jairtraman. . . key: cord- - by r authors: khalifa, shaden a. m.; mohamed, briksam s.; elashal, mohamed h.; du, ming; guo, zhiming; zhao, chao; musharraf, syed ghulam; boskabady, mohammad h.; el-seedi, haged h. r.; efferth, thomas; el-seedi, hesham r. title: comprehensive overview on multiple strategies fighting covid- date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: by r lately, myriad of novel viruses have emerged causing epidemics such as sars, mers, and sars-cov- , leading to high mortality rates worldwide. thus, these viruses represented a challenging threat to mankind, especially considering the miniscule data available at our disposal regarding these novel viruses. the entire world established coordinative relations in research projects regarding drug and vaccine development on the external range, whereas on the internal range, all countries declared it an emergency case through imposing different restrictions related to their border control, large gatherings, school attendance, and most social activities. pandemic combating plans prioritized all sectors including normal people, medical staff politicians, and scientists collectively shouldered the burden. through planning and learning the previous lessons from sars and mers, healthcare systems could succeed in combating the viral spread and implications of these new pandemics. different management strategies including social distance, social awareness and isolation represented successful ways to slow down the spread of the pandemic. furthermore, pre-preparedness of some countries for emergencies is crucial to minimize the consequences of the crisis. . comparison between total deaths and confirmed cases in some countries with different population from jan till april [ ] . most countries were forced to announce emergency measures to protect vulnerable people and block ways of transmission due to the continuous increase in confirmed cases by time as reported in figure [ ] [ ] [ ] [ ] [ ] [ ] . with regard to this escalating situation, governments have begun to develop strategies to resolve the pandemic cooperatively with international health agencies, i.e., centers of disease control (cdc) and world health organization (who) that declared many precautions based on previous lessons from mers and sars diseases, as will be outlined in this section. our review aims to evaluate strategies of the most affected countries from different continents all over the world (china, italy, germany, france, spain, america, canada, brazil, uk, india, japan, singapore, iran, korea, and australia) for confronting the epidemic as it explains the best practices that could help other countries to overcome current or any upcoming pandemic. most countries were forced to announce emergency measures to protect vulnerable people and block ways of transmission due to the continuous increase in confirmed cases by time as reported in figure [ ] [ ] [ ] [ ] [ ] [ ] . with regard to this escalating situation, governments have begun to develop strategies to resolve the pandemic cooperatively with international health agencies, i.e., centers of disease control (cdc) and world health organization (who) that declared many precautions based on previous lessons from mers and sars diseases, as will be outlined in this section. figure . change in numbers of confirmed cases over time [ ] [ ] [ ] [ ] [ ] [ ] . the chinese lunar new year holiday, which synchronized with the outbreak of covid- , is the most celebrative time of year in china. usually, a large global migration takes place, as individuals travel back to their homes. around five million people had left wuhan [ ] . around a third of those people travelled outside the province of hubei. restricting people's social contacts was critical to covid- regulation. key elements of such social distancing initiatives included that the chinese government promoted people to stay home, dissuaded mass gathering, postponed or the chinese lunar new year holiday, which synchronized with the outbreak of covid- , is the most celebrative time of year in china. usually, a large global migration takes place, as individuals travel back to their homes. around five million people had left wuhan [ ] . around a third of those people travelled outside the province of hubei. restricting people's social contacts was critical to covid- regulation. key elements of such social distancing initiatives included that the chinese government promoted people to stay home, dissuaded mass gathering, postponed or cancelled major events, and closed universities, factories, museums, libraries, schools, and governmental offices. chinese people began to take steps to shield themselves from covid- , i.e., wearing protective masks, if they had to commute in public. social distancing has been successful in limiting human to human transmission and cutting morbidity and mortality. more stringent steps are introduced such as isolation and quarantine. the lunar new year holiday was expanded by chinese government. the holiday deadline was shifted to march for hubei province and feb for other provinces, so that the holiday duration was long enough to cover the alleged covid- incubation time. diagnosed people were segregated in hospitals. in wuhan, in which a large number of infected people resided, people with mild or asymptomatic infections were quarantined at shelters called fang cang hospitals, which were public open areas, i.e., stadiums and convention centers that had been retooled for medical treatment. the chinese government promoted and funded grassroots screening for contact tracking and early detection and encouraged hand-washing and surface sanitization. home-based quarantine of people who were at the epicenters of epidemic and travelled to other places in china to curb the spread of virus to boarder populations. the government avoided panic amongst people by providing the updated information through media. free medical care was introduced by the state to motivate patients to visit doctors as soon as possible and in good time to prevent further deterioration of the condition. the state guaranteed people's daily needs [ ] . the state with the second highest numbers of viral deaths worldwide. the government declared a state of emergency lockdown that began in northern italy and spread throughout the world. the fatality rate ( . ) was much higher than that of china ( . ). all italian regions were known as "red zones" with extreme limits imposed on every public event. italy responded to the situation with screening even for those without symptoms. italy faced a persistent shortage of health care staff. the government announced a proposal to recruit , new doctors, nurses, and health workers to meet demand. retired doctors and students who had finished their medical degree and are in the final year of specialist training, were called upon [ ] . coordinated intensive care units were equipped for covid- positive patients. continuous training for health care staff was crucial with applying dedicated protocols and full isolation [ ] . the rules initially laid down approximately one month for schools' closures and restrictions on people's right to leave homes and two weeks for the suspension of business activities. the italian government proposed an extension of lockdown steps [ ] . to curb viral transmission, air travels were banned from china and italian passengers were quarantined in china. suspected cases were moved to pre-defined hospitals where the check for sars-cov- was available and infectious disease divisions were willing to isolate confirmed cases. emergency medical system of milan metropolitan area formed covid- response team with main goal of resolving the viral pandemic without encumbering regular emergency medical system activities. the response team examined the health and clinical conditions of persons being screened to evaluate the need for hospitalization or home testing and subsequent isolation. this response team designed algorithm to identify covid- suspected cases. the algorithm is continuously modified to comply with the regional directives [ ] . in a speech about the coronavirus pandemic, german chancellor angela merkel approached the citizens directly. she explained the situation this way "it is serious. take it seriously too!". "since world war ii, there has been no other challenge to the country, where national solidarity was as important as right now", she said. the german chancellor announced stricter steps and declared standards/rules for germany. the main objective was to "reduce public life to the extent warranted". this included restriction of the bare minimum connections, maintenance of a minimum distance to the public of at least . m, permission for people to go to work, doctors, shops, and play outdoor sports individually. however, gatherings in groups or meeting were no longer permitted [ ] . france, like other nations formed their pandemic influenza plan (pip) based on the recommendations for the contagion management by who. president macron clarified that only collective national campaign can prevent the spread of infection, restrict deaths, and avoid the submergence of health service. french pip aimed to alleviate pandemic by minimizing the number of civilian casualties and preserving machinations in particular economic activities. pip included stages: the st stage was to impede the introduction of outbreak to the world, nd stage to restrict viral growth and distribution in france, rd stage to attenuate the potential outbreak to minimum and th stage was returning to normalcy. first reported cases were chinese nationals visiting france, so steps were rapidly taken to keep these cases in isolation. contact tracing was held to identify people at risk of infection. the government cancelled all sporting events and schools were also closed. authorities have repeatedly pronounced individual habits and requested protective masks for those who show signs of infections and for health workers so, public and private sectors were mustered to produce masks and disinfectants. to prevent viral transmission, france pressured the european union to close the schengen treaty zone for all non-european citizens. despite the strategy's economic impacts, france scarified the entire society to combat covid- [ ] . on march, the spanish government started the applications of safety measures, in order to flatten the curve days after the exponential rate of virus start (r < ); the day in which new cases were registered for the first time. all people were forced to stay home through announcing the lockdown. spain has adopted some measures to control spread: social distance, closure of most activities, e.g., cinemas, clubs and schools to avoid crowding [ ] . under supervision of the president of the government, pedro sánchez, who described the crisis as: "unprecedented challenge", "a global threat that recognizes no borders, colors or languages", and an "extraordinary challenge that forces us to take exceptional measures". he assured the importance of application of distance learning as much as possible to slow down viral spread. they reduced non-essential work to conserve support to different sectors including the vulnerable categories, the elderly, families with the lowest resources, and small business owners. their strategy included increasing the awareness that each person in the community has a role in combating the virus; elderly people receive intensive care and the young follow the safety measures and social distancing. everyone had to care of others and the sense of social responsibility was increased. moreover, they had a continuously announced transparent data from the beginning beside their steps to prevent infection through following the guidelines and health monitoring protocol [ ] . the director-general of the world health organization (who) announced that the covid- pandemic had triggered an international public health emergency. the united states department of health and human service secretary announced on january a u.s public health emergency, and the u.s. president legitimated a "proclamation on suspension of entry as immigrants and non-immigrants of persons that pose a risk of transmitting novel coronavirus". this regulation restricts the entrance of american citizens and those with legal permanent residents and their families, especially those who have travelled to mainland china. the centers of disease control and prevention (cdc) and other governmental agencies, as well as state and local health centers, introduced proactive steps to limit covid- propagation in the u.s. [ ] . such steps included the recognition of cases and their contacts, and the suitable care of travelers coming from china to the u.s. the correct actions were taken to ( ) slow down virus spread; ( ) prepare health care systems and encourage public willingness for pervasive transmission; and ( ) clearly define infection and directly report to public health centers in order to make decisions and improve medical safeguards involving diagnosis, therapy, and vaccines [ ] . despite the fact that these initiatives were being enforced in anticipation of the virus in the u.s., the continued widespread dissemination of the virus was devastating. usa holds a negative record in regard to the pandemic, with the highest number of infections and deaths recorded worldwide. public health and disease prevention programs in canada were refashioned around guidelines and recommendations of naylor and his group that were used before against sars and entitled "learning from sars". experience with sars affected positively canada's response to the covid- outbreak. most notably, correspondence concerning public health was greatly improved and digital media was progressed. there were some technological gaps like contrasting directives on the use of personal protective equipment but this has been mainly resolved. in airports, procurement were organized and rolling tests became faster [ ] . previous preparedness before incidence of infection was phenomenal in brazil. on january , the health surveillance secretariat together with the ministry of health activated an emergency health operation center with low alerting level, which was raised later on january when the first suspected corona virus case appeared. national contingency plan (ncp) for the covid- and guidelines; based on information received from who were announced to be applied in all states. quarantine law was imposed for protecting people. isolation and exceptional restrictions on travelling was applied even before the appearance of the first case. currently, there is a rapid growth in cases in brazil; cases and deaths were registered only one month after the first confirmed case [ ] . trials to reduce cases were implemented and huge attention was paid towards availability of intensive care units (icus), diagnostic tests and ventilators needed for patients with covid- [ ] . brazil suffered from political flounder, which constituted distraction in the middle of crisis. the government restricted the use of rt-pcr examinations to people with more severe symptoms leading to higher mortality rates. this was due to high cost of materials and shortage in qualified people and labs able to do the rt-pcr test and the needed transportation for samples to places, where tests are performed. thus, people with mild symptoms or the asymptomatic caused the transmission of infection. dense populations on favelas made it impossible to follow the social distance. moreover, illegal mining and logging in amazon forests may have brought infections to remote areas. scientific organizations, such as the brazilian academy of sciences opposed bolsonaro due to the decreased science budget, general security, and shortage of public services. currently, there is increased production of personal protective equipment, ventilators, and diagnostic kits [ , ] . the united kingdom (u.k.) government followed health's department direct recommendations for travelling abroad with respiratory infections, especially travelling to wuhan [ ] . the u.k. national health service emphasized the importance of using personal protective equipment, obtaining a detailed history of travelling, and rapidly escalating suspicious cases with a dedication to isolate patients. any confirmed cases of covid- should be moved to an airborne high impact infectious disease center such as the two major centers in england (royal free hospital in london and newcastle royal victoria infirmary). u.k. chief medical officers told individuals who had toured wuhan or hubei province over the past days to stay at home and call national health service number . such recommendations were also applied to people, who have visited japan, thailand, hong kong, singapore, taiwan, macau, and malaysia [ ] . the world's second most densely-populated country after china made the situation worse, since population density beside some other factors contributed to the wide viral transmission [ ] . poverty and money-related problems complicated combating strategies. if the government imposed social distance ( m distance), many categories opposed the actions, especially craftsmen. ignorance from indians at first increased the number of infected people [ ] . then, the government imposed a strict lockdown for days except for some services such as fire departments, police, and hospitals. diagnostic kits were increased every day and in every state. train coaches were turned to mobile wards for isolation. a phone application was launched called aarogya setu (health bridge) aiming to track people's health [ ] . check points were built at borders to check people entering the country, and all borders were shut. the ministry of health and family welfare (mohfw), india, increased awareness, took actions to control covid- and guidelines on management; prevention and sample collection were announced. also a hotline was created with a h/ days-a-week service to help people [ ] . a huge budget of about us $ . billion was endowed for health sector to combat covid- . the department of science and technology, government of india tried to promote research in university institutes and started working in various directions to control the virus during the country's lockdown. the indian council of medical research (icmr) launched private labs with suitable safety regulations to test covid- samples. icmr reported that about , tests (as of april ) were performed in india. blood plasma therapy using the plasma of recovered patients with immunity against covid- was applied to infected individuals. the indian strategies paid the most attention for medical care requirements. thus, the number of infected people is less than other countries due to exerted efforts by authorities to impose the strict lockdown. yet even after lockdown removal (fully or partially) on may , the threats amplified [ ] . on june , the ministry of health and family welfare (mohfw) announced that , confirmed covid- cases and deaths from states especially the states of maharashtra, tamil nadu, delhi, and gujarat. hence, the case-fatality rate became . % [ ] . it is not the first time for japanese people to face a national crisis, as they previously experienced two atomic bombings in , the sarin gas in , and the h n epidemic in . thus, fear and anxiety was dominating. images, headlines, rumors and confirmation of human-to-human transmission in nara prefecture played a role. anxiety-related behaviors appeared significantly in shortage of masks and sanitizers in drug stores, social rejection, discrimination against affected people [ ] . however, preparedness and learning from previous lessons was effective. japan reported low numbers of covid- -related deaths due to the following measures. to prevent infection, emergency state was declared on april and continued for a month. people were asked to stay home and stop un-essential activities. japanese customs suited for social distancing, as they exclude handshaking, hugging, or kissing in greetings [ ] . usage of long-term care areas with the most vulnerable residents was temporarily suspended. japanese people were asked to avoid crowded places with bad ventilation and conservation of physical distances according to recommendations of an expert committee [ ] . travels were restricted from and to wuhan, and japanese citizens were asked to evacuate china. subsequently, three flights transported them back home. healthy individuals were isolated, prevented to move around and kept under medical observation at designated hotels, while others with disease symptoms upon arrival in japan were admitted to hospitals [ ] . singapore, the regional travel center in southeast asia, was one of the first places to be impacted by covid- . the singapore strategies were based on back experience with sars outbreak. an important lesson was to ensure cohesive response across all sectors, consistent leadership and guidance was crucial. therefore, a multi-ministerial task force was established to provide central leadership for all government crisis management, before singapore had its first covid- incident. an intensified surveillance system was developed to monitor covid- cases between hospital and primary care pneumonia patients. to promote this system, covid- rt-pcr laboratory tests were rapidly expanded to all singapore hospitals with tests per day for . million persons. suspected and confirmed cases were isolated in hospitals immediately to avoid further transmission. contact tracing was also started to determine their past locomotion before isolation to identify potential sources of infections. more than public health preparedness clinics has been set up to facilitate the control of primary care of respiratory diseases. incoming travelers were subjected to temperature and health checks at all airports and suspicious cases sent immediately to hospitals. singapore's community approach focused on social responsibilities while precautionary life kept going as usual. social education was a key empowerment strategy and carried out through print, broadcast, and social media. workers are empowered to continuously monitoring temperature and health and organizations are motivated to step forward their business plans. schools remained opened with precautions. even though these precautions were enforced, singapore retained normality of daily life [ ] . by march , the viral spread increased, and all provinces were affected. then, by april the number of confirmed cases reached , with deaths in iran. the government prohibited many activities: sale and export of face masks to legal entities were limited, commercial movements with china were prevented, and travel was banned. cancelation of all public gatherings, including cinemas, concerts, theaters, postponement of weddings, parties, conferences, seminars, camps and collective sports, school closure, and establishing e-learning, reduced office hours for h/day [ ] . people were guided for hand-washing and wearing masks. suspected and infected people with covid- were isolated for days [ ] . poor people were severely affected by quarantine; hence, the government financially supported them. the supreme council for health and food security together with a special council for covid- confessed essential deficiencies in policies regarding food security including delays in bills such as electricity, payment of bank loans. however, reductions in oil prices and oil selling due to sanctions significantly affected the ability of governmental support [ ] . the iranian ministry of health and medical education (mohme) compiled the who guidelines for covid- prevention and announced them through different platforms. hotlines to answer questions and give advice on nutrition and mental health were available. national campaigns for increasing awareness and information were held to improve public knowledge. a website was launched (salamat.gov.ir) to help people and answer their questions [ ] . the political situation in iran impacted the economic infrastructure, which indirectly affected the health sector and the first-line defense against the virus. thus, the burden scaled up. in addition, the weakness of the medical infrastructure, inadequate personal protective equipment and difficulties in importing them are all key factors. quarantining cities was rather ineffective due to viral distribution throughout the country [ ] . korea's infection alerting system has four levels: ( ) attention to the epidemic as the government began tracking, ( ) caution if an epidemic reached the country and the government maintained a program of cooperation, ( ) activation of response system that could be alerted regarding to spread of infection, and ( ) development of a national response program, as the outbreak progressed and became serious. four days after announcement of new cases in china, korea began screening and enforced quarantine program at the airports. everyone who had visited wuhan during the past days was asked to complete health questionnaire and to have days of self-quarantine. if there was fever or respiratory ailments, they should call korea cdc. early recognition helped korea remove the community infection and limit it to medical facilities which was an integral part of outbreak response. a -h rapid test was distributed in all health centers around the country. korea cdc started recording the crisis to provide reliable data. such reports included number and history of suspected cases with public guidance for prevention. travel to china was cancelled. korea goals were accomplished through key strategies: st outbreak based on suppression and mitigation, nd risk awareness to encourage community involvement, and rd science-based and reality driven behavior [ ] . australia built its response to covid- on the basis of its powerful healthcare system. australia realized that people involved in primary care, elderly care, home care, and disability care need the same degree of support and safety as people working in hospitals in attempt to preserve both public and vital health care system to sustain the workplace of services. good, coherent contact with the primary care staff and general public was very critical for the needed steps. borders were shut down, non-essential facilities were closed, precautionary measures were in the places with infection risk, stringent social distancing were enforced together with quarantining of individuals with suspected infection or confirmed infection. the prime minister of australia stated the implementation of the novel coronavirus emergency response program for australian medical sector. the four strategic goals of the targeted plan were: protecting people from covid- effects, maintain health care functional capacity, facilitate the most appropriate treatment of people with symptoms, manage, and control personal protective equipment. the australian government introduced . billion primary care packages to safeguard all australians. primary care approach has main components: telemedicine services, online infection control training provided to all caregivers, institution of general practice-led primary healthcare respiratory clinics ( clinic) to transfer affected people away from other general practices [ ] . most governmental strategies are summarized in figure . collectively, demographic diversity, standard of living of each country's citizens, political state and health systems in addition to other factors led to various strategies being implemented across the globe trying to cope with the crisis. however, the collaboration and sharing of responsibility for controlling the pandemic through exchange of information between countries was the most important step. taken together, countries facing covid- or any other pandemic should consider control or closure periods and whether required or compulsory closure of unneeded workplaces and public entities as a first line of social distance measures can reduce transmission rate. the closure times should be adapted to the unique characteristics of the novel disease, i.e., the incubation duration and transmission routes, and the nature of these outbreaks. the main purpose of the pandemic control closure phase is to avoid the spread of disease by people with asymptomatic infections. governments should use closure times to optimize effect, promotions, group screening, active communication, monitoring, isolation, and quarantine. some countries have promoted their people's consciousness across many channels, e.g., television, newspapers, and conferences. they have been resorting to the use of more modern health and education technologies i.e., e-learning and telemedicine to reduce the urge to go outside. such a hybrid strategy is also backed up by analyses of responses to previous pandemics, which have shown that average attack rate reductions were more noticeable if social distance policies and other disease prevention steps were combined to prevent transmission. sars-cov- spreads at an astonishing speed across the globe. on january , who collectively, demographic diversity, standard of living of each country's citizens, political state and health systems in addition to other factors led to various strategies being implemented across the globe trying to cope with the crisis. however, the collaboration and sharing of responsibility for controlling the pandemic through exchange of information between countries was the most important step. taken together, countries facing covid- or any other pandemic should consider control or closure periods and whether required or compulsory closure of unneeded workplaces and public entities as a first line of social distance measures can reduce transmission rate. the closure times should be adapted to the unique characteristics of the novel disease, i.e., the incubation duration and transmission routes, and the nature of these outbreaks. the main purpose of the pandemic control closure phase is to avoid the spread of disease by people with asymptomatic infections. governments should use closure times to optimize effect, promotions, group screening, active communication, monitoring, isolation, and quarantine. some countries have promoted their people's consciousness across many channels, e.g., television, newspapers, and conferences. they have been resorting to the use of more modern health and education technologies i.e., e-learning and telemedicine to reduce the urge to go outside. such a hybrid strategy is also backed up by analyses of responses to previous pandemics, which have shown that average attack rate reductions were more noticeable if social distance policies and other disease prevention steps were combined to prevent transmission. sars-cov- spreads at an astonishing speed across the globe. on january , who announced the outbreak of covid- an international public health emergency which impacted countries (status: march ) [ ] . the speed and extent of pandemic detection, particularly early diagnosis and notification of new cases, is an important measure to monitor this infectious disease. countries that have previous experience with viral infectious diseases (most commonly sars), powerful primary care systems with helpful infrastructures, guidance rules and instructions, and community awareness with social responsibilities prove to be more effective in controlling the spread of infection and reducing its deleterious impacts. numerous countries endeavor to construct an info-structure of national digital health in order to improve disease surveillance and link public health and clinical intelligence programs. clear and open contact between governments and healthcare staff would be pivotal. it was the time for hospitals or agencies that engage in healthcare delivery to audit its protocols and consumables for all selected patients. heads of state, global health leaders, private sector partners, and other stakeholders have accelerated global partnership to speed up the production of covid- diagnostic and preventive tools. all governments should prepare the public for a second wave or another outbreak. national policy discussions about the future of the respective society should be initiated. covid- is a tragedy for us all collectively, but it is also an opportunity to ask ourselves what kind of society we want after the pandemic fades away. reproduction numbers of infectious disease models molecular mechanisms of coronavirus rna capping and methylation genomic characterisation and epidemiology of novel coronavirus: implications for virus origins and receptor binding origin and evolution of pathogenic coronaviruses the novel zoonotic covid- pandemic: an expected global health concern systematic review: national notifiable infectious disease surveillance system in china study of surveillance data for class b notifiable disease in china from to three emerging coronaviruses in two decades: the story of sars, mers, and now covid- covid- ): situation report- covid- ): situation report- covid- ): situation report- coronavirus disease (covid- ) situation report- . available online coronavirus disease (covid- ) situation report- . available online coronavirus disease (covid- ) situation report- . available online coronavirus disease (covid- ) situation report- . available online the model of epidemic (covid- ) prevention and control in rural of china covid- control in china during mass population movements at new year on the front lines of coronavirus: the italian response to covid- hospital surge capacity in a tertiary emergency referral centre during the covid- outbreak in italy compliance with covid- social-distancing measures in italy: the role of expectations and duration the response of milan's emergency medical system to the covid- outbreak in italy merkel announces strict measures and tells germans to stay home in virus fighle adaptation of the national plan for the prevention and fight against pandemic influenza to the covid- epidemic in france effectiveness of the measures to flatten the epidemic curve of covid- . the case of spain president of the government calls for political and public unity to overcome coronavirus emergencyle proclamation on suspension of entry as immigrants and nonimmigrants of persons who pose a risk of transmitting novel coronavirus initial public health response and interim clinical guidance for the novel coronavirus outbreak-united states learning from sars. lancet characterization of the covid- pandemic and the impact of uncertainties, mitigation strategies, and underreporting of cases in south korea, italy, and brazil covid- in brazil covid- - million cases worldwide and an overview of the diagnosis in brazil: a tragedy to be announced covid- ): situation report- world health organization declares global emergency: a review of the novel coronavirus (covid- ) projections for covid- pandemic in india and effect of temperature and humidity covid in india: strategies to combat from combination threat of life and livelihood investigating the dynamics of covid- pandemic in india under lockdown the rise and impact of covid- in india covid- pandemic in india: present scenario and a steep climb ahead public responses to the novel coronavirus ( -ncov) in japan: mental health consequences and target populations why does japan have so few cases of covid- ? clusters of covid- in long-term care hospitals and facilities in japan the rate of underascertainment of novel coronavirus ( -ncov) infection: estimation using japanese passengers data on evacuation flights interrupting transmission of covid- : lessons from containment efforts in singapore covid- pandemic and comparative health policy learning in iran the challenges and considerations of community-based preparedness at the onset of covid- outbreak in iran ensuring adequate health financing to prevent and control the covid- in iran ir of iran national mobilization against covid- epidemic coronavirus disease (covid- ) outbreak in iran: actions and problems lessons learned from korea: covid- pandemic crossref] . world health organization. responding to community spread of covid- : interim guidance the authors declare no conflict of interest. key: cord- -jx xpbjl authors: alsan, marcella; bloom, david e.; canning, david title: the effect of population health on foreign direct investment inflows to low- and middle-income countries date: - - journal: world dev doi: . /j.worlddev. . . sha: doc_id: cord_uid: jx xpbjl this paper investigates the effect of population health on gross inflows of foreign direct investment (fdi). we conduct a panel data analysis of industrialized and developing countries over – . our main finding is that gross inflows of fdi are strongly and positively influenced by population health in low- and middle-income countries. our estimates suggest that raising life expectancy by one year increases gross fdi inflows by %, after controlling for other relevant variables. these findings are consistent with the view that health is an integral component of human capital for developing countries. the effect of population health on foreign direct investment inflows to low-and middle-income countries the world health organization's report of the commission on macroeconomics and health (cmh, ) asserts: ''a healthy workforce is important when attracting foreign direct investment (fdi).'' many international agencies have made similar statements regarding the effect of health on fdi inflows. such claims have bolstered the position of health on the global development agenda. to date, however, a relationship between population health and fdi has not been established in the empirical literature. the aim of this paper is to investigate whether population health encourages inflows of fdi after controlling for other relevant variables. this study is important for two main reasons. first, developing countries continue to face severe resource constraints. placing budgetary priority on health interventions at the expense of competing claims merits a strong evidence-based foundation. second, the expanding role of fdi in the global economy has made understanding its determinants a priority for both researchers and policy makers. there are several reasons for why population health might be important for attracting fdi. a growing body of evidence has shown that health is an integral component of human capital that raises worker productivity and spurs economic growth. high levels of human capital in the workforce are likely, other things being equal, to make a country more attractive to foreign investors. on the other hand, high rates of absenteeism or worker turnover due to morbidity and mortality can raise production costs and deter fdi. a large burden of infectious diseases might also dampen fdi inflows to a given locale if investors fear for their own health or that of their staff. to investigate if health status of a population affects fdi inflows, we conduct a panel data analysis of industrialized and developing countries over the period - . our main finding is that fdi inflows are strongly and positively influenced by population health among the sample of low-and middle-income countries. our estimates suggest that raising life expectancy by one year increases fdi inflows by % in these countries, after controlling for other relevant factors. these findings are consistent with the view that health is an integral component of human capital for developing countries. the remainder of the paper is organized as follows: section presents stylized facts regarding fdi and its relationship to developing countries and human capital; section reviews empirical evidence and theoretical arguments for considering health as a form of human capital; section describes the theory of fdi inflows and the empirical model used in the analysis; section details the data used and our sources; section presents our empirical results; and section concludes. to the best of our knowledge, this represents the first empirical investigation evaluating whether health directly affects fdi, ceteris paribus. fdi has become an increasingly important source of financing worldwide. during the past two decades, global inflows of fdi have soared: from $ billion in to $ billion in (unctad, ) . attracting fdi is important for countries at all stages of development. it has been argued, however, that inducing greater fdi inflows is of more importance to developing countries given their lower savings rates and income levels. indeed, fdi now represents the largest component of net resource flows to developing countries, surpassing official development assistance (oda), portfolio investments, and bank loans (miyamoto, ) . in addition to providing much needed capital, fdi has other attributes of particular relevance for developing economies. these attributes include expanding access of domestic firms to global markets and facilitating the transfer of technology. fdi may also increase tax revenue for the host economy and enhance the competitiveness of the domestic market through spillover effects (loungani & razin, ; unctad, a) . these potential benefits of fdi have been widely publicized. leaders gathered at the international conference on financing for development (icfd), held in mexico in , characterized fdi as an engine for economic growth and an integral component of poverty alleviation. the monterrey consensus, adopted at the icfd, stated, ''a central challenge, therefore, is to create the necessary domestic and international conditions to facilitate direct investment flows . . . to developing countries'' (united nations, ) . this challenge has not yet been met. global fdi inflows are not distributed evenly. industrialized economies are the most likely destination for fdi; and some developing countries receive much greater inflows than others. african countries in particular have struggled to attract foreign investors (see morisset, ) . in , africa attracted only $ billion in foreign investment; far less than central europe ($ . billion), latin america ($ billion), or asia ($ . billion) (unctad, ) . asiedu ( ) , empirically investigating the determinants of fdi to developing countries, found that sub-saharan african (ssa) countries were less likely to attract investors than non-ssa countries, despite the fact that us investment into ssa had a higher rate of return than investment in other developing regions. furthermore, factors proven to promote fdi to non-ssa countries (such as infrastructure and return on capital investment) did not have a clear impact on fdi to ssa countries. a survey conducted by the united nations conference on trade and development (unctad) of the leading multinational enterprises supported asiedu's results. only one out of every five respondents expected higher inflows to african countries over the next two years, and two-thirds believed that the current level of flows would remain unchanged (unctad, b) . under standard neoclassical assumptions (where output is produced by capital and labor), capital is predicted to flow from wealthy to poor countries until capital-labor ratios equalize across countries. the observed pattern of fdi, with most capital flowing from one wealthy country to another, is thus an apparent paradox. lucas ( ) argues that differences in human capital could explain this paradoxical pattern. recently, there has been renewed interest in the idea that human capital might play a role in encouraging foreign investment. to the extent that physical capital and skills are complementary inputs, the presence of a healthy and more highly educated workforce can increase the productivity of capital. this is driven in part by economic activity shifting first from the primary goods to manufacturing sectors and then toward services, which are successively more knowledge intensive. for example, in the early s, the services sector accounted for only % of the world fdi stock. by , services had risen to about % of the total stock (unctad, a) . fdi geared to knowledge-and skill-intensive industries may imply that countries with higher levels of human capital are more attractive to investors (blomströ m & kokko, ; miyamoto, ; noorbakhsh, paloni, & youssef, ) . most cross-country studies investigating this idea identify human capital narrowly with education, ignoring strong reasons for considering health as an integral component of human capital. therefore, in a natural extension of the literature, we investigate whether the health status of the population encourages inflows of fdi. in section , we review empirical evidence establishing health as a form of human capital and summarize circumstantial evidence suggesting a link between health and fdi. in addition to the importance of health as a consumption good, health can also be viewed as a form of human capital that enhances economic performance both for the individual and at the level of the macroeconomy (bloom, canning, & jamison, ) . a substantial body of evidence has demonstrated that population health is a robust predictor of growth in per capita income (barro, ; barro & sala-i-martin, ; bhargava, jamison, lau, & murray, ; bloom, canning, & sevilla, ) . however, countries may benefit to different degrees from health. bhargava et al. ( ) argue that economic growth resulting from health improvements is more pronounced in developing countries than in industrial countries. health can affect economic performance through direct and indirect mechanisms. health has a direct effect on the productivity of workers. healthy workers are generally more physically and mentally robust than those afflicted with disease or disability. furthermore, they are less likely to be absent from work, or suffer low productivity in work, due to personal or household illness. poor health can lead to low wages, which in turn keeps health and nutrition levels low, thereby creating a poverty trap. microeconomic analyses using anthropometric measures (such as the onset of menarche, nutritional status, and stature) and indices of morbidity (such as work days lost due to illness) have consistently shown that health affects worker productivity (knaul, ; ribero, ; savedoff & schultz, ; schultz & tansel, ; strauss & thomas, ) . health can also affect economic performance through indirect mechanisms; for example, improved health can increase the return to education and worker experience. healthier children have enhanced cognitive function and higher school attendance, allowing them to become better educated, higher earning adults (bhargava, ; bloom, ) . healthier workers, who have lower rates of absenteeism and longer life expectancies, acquire more job experience. better health also improves the prospective lifespan of workers. in countries with low life expectancies, the prospect of retiring is remote. once better health becomes more common, retirement seems more attainable. increased longevity, therefore, can generate the need for retirement income and set off a savings and investment boom (bloom, canning, & graham, ) . health improvements may also affect the age structure of populations. initially, such improvements tend to reduce mortality rates among infants and children, since interventions to reduce childhood mortality are usually neither costly nor complex. as parents come to expect more of their children to survive to adulthood, fertility rates fall. this change produces a baby boom generation. the fall in birth rates, coming as it does after a fall in mortality rates, means that the large baby boom generation is unique, with much smaller cohorts before and after it. as this generation enters the workforce, it may provide a boost to productivity leading to economic growth (bloom & canning, ) . health, viewed as a form of human capital, could affect fdi through several mechanisms. as the cmh report suggested, a healthy workforce could enhance worker productivity and attract fdi inflows. however, health may also encourage fdi via other mechanisms. firm profitability may suffer if health-related costs are high. companies operating in countries where health infrastructure and personnel are lacking may need to develop or significantly subsidize a health care system for their employees. sick leave, funeral costs, and low workforce morale represent additional burdens for investing firms. in addition, for fear of endangering their own health and that of their expatriate staff, foreign investors may shun areas where disease is rampant and where access to health care is limited. foreign investors and their managerial staff may lack resistance to disease, either acquired or inherited, that the host country population enjoys. for example, a significant portion of the population in africa carries the sickle cell trait. this condition confers protection from severe malaria and is much less common among european descendants (pasvol, weatherall, & wilson, ) . a similar reduction in disease severity has been observed with certain types of thalassemia (clegg & weatherall, ) . indeed, these inherited hemoglobinopathies are thought to persist among certain african and asian populations because natural selection favors alleles offering protection against malarial illness. a classic instance of disease interfering with investment occurred during the building of the panama canal. yellow fever and other pathogens claimed the lives of , - , workers during - , forcing ferdinand de lesseps and the french to abandon the construction project (jones, ) . more recently, the outbreak of severe acute respiratory syndrome (sars) has highlighted fears that new infectious disease outbreaks could undermine global integration and deter foreign investment. preliminary evidence seems to support this view. a global business survey on hiv/aids sponsored by the world economic forum (bloom, bloom, steven, & weston, ) found that half of all business leaders in low-income countries believe that hiv affects their country's access to fdi. as well as affecting the costs of production, health may also affect the level of demand. healthy populations are more productive, earning higher incomes and creating a larger market for goods. in addition to this effect on aggregate demand, health may also have consequences on the pattern of demand, with direct effects on the demand for health services and more indirect effects on sectors such as tourism. even though circumstantial evidence suggests a link between health and fdi, empirical findings are noticeably absent. the gap in the literature is not without consequence. as competition for oda rises and questions about the effectiveness of foreign aid are raised, developing countries are increasingly looking to fdi to promote technology transfers and economic growth. we now turn to the model. firms invest in foreign countries, instead of exporting to them or licensing to a local company, to satisfy one of two strategic objectives. they may seek to better serve the local market, producing locally to avoid transportation costs, trade barriers, or production delays and speed information flow. this is market-seeking or horizontal fdi. alternatively, they may seek to produce for the global market but select this location to minimize production costs through lower-cost inputs. this is export-oriented or vertical fdi (shatz & venables, ) . in principle, health can affect both vertical and horizontal fdi. local production allows a firm to avoid transportation costs and import duties; but this is only attractive if the domestic market is sufficiently large to cover the fixed costs of setting up production and any country-specific cost disadvantages. asiedu ( ) and blonigen and wang ( ) conjecture, reasonably, that horizontal fdi will be driven largely by domestic demand (market size). along the same lines, other investigators have traditionally found that host market size, usually measured in terms of real gross domestic product (gdp) per capita and population size, is a positive determinant of fdi inflows (chakrabarti, ; schneider & frey, ; wheeler & mody, ) . by contrast, ceteris paribus, vertical fdi will flow to countries that possess cheap, productive inputs and have the fewest restrictions on trade. the presence of highly educated, healthy workers, available at low wages, may be a large inducement for vertical fdi. we can formalize this. let us begin with a model of export-oriented or vertical fdi. assuming constant returns to scale, profit maximization, and competitive markets, the profits earned by a unit of fdi can be expressed in the form of a profit function given by where p y is the world price of the output produced, p k is the local cost of capital, p x is the local cost of an input (in general, there will be many inputs into production), and z represents the per unit costs due to factors such as transportation, tariffs, and corruption in the host economy. in this model, all fdi will flow to the country with the highest profit rate. now suppose that the cost of investment rises as the volume of fdi (which we denote by i) expands depending on s, the absorptive capacity of the country with a quadratic adjustment cost would be according to the idea is that as aggregate fdi increases some resources become scarce, increasing the cost of investing. note that this model applies to gross inflows of fdi, since it is the gross inflows and not the net balance of fdi flows that has to be absorbed. the price of capital facing an individual company undertaking fdi depends on the aggregate volume of fdi and is investment of fdi in each country will take place up to the point where the profitability of investment is equalized across countries p ¼ f ðp y ; p k ðiÞ; p x ; zÞ. solving this as an implicit function for i gives the terms with the superscript refer to worldwide variables that are the same for each country (though they may vary over time), while the other variables are country specific. we proxy s, the absorptive capacity of the economy for fdi, by population size and income per capita. we do not have local prices for each input in our model. the profit function f of the firms involved in fdi implies an underlying production function. however, the aggregate production function of the economies these firms are investing in may be quite different. suppose the aggregate production function for the domestic economy is cobb-douglas and is given by where y is output, k is capital, l is labor, x is some other input (e.g., health), and a is total factor productivity. profit-maximizing firms will choose input levels for x so that the marginal product of x equals its real price (in output units) p x . this implies that and hence, it follows that we can regard the per-worker level of an input that is available in an economy (for a given level of income per capita) as a proxy for its price, with higher levels of an input per worker associated with lower input prices and lower input levels associated with higher prices. the level of output per worker is also a proxy for the general level of input prices. we can control this by including the level of income per capita in the regression. in this framework, countries with a high level of income per capita are likely to have high factor prices which will deter investment, while countries with high levels of a particular input per capita, given their income level, will have low prices for that input, which will encourage investment. we also include a number of variables, such as corruption and distance to major markets, that may add to costs of production. note that the production function for firms undertaking fdi implicit in the profit function f (eqn. ( )) may be quite different from the existing aggregate production function for the economy (eqn. ( )) that determines the link between domestic factor availability and factor prices. this allows for the possibility that fdi firms have different technology from the existing firms in the economy. our model does not, however, allow for the possibility that fdi firms are interested only in some specialized factors of production that are not captured accurately by broad aggregates. however, using national averages makes the empirical investigation tractable, since data on the availability and cost of inputs at the local level are not readily available for many developing countries. the model set out here is one of exportoriented or vertical fdi. for most low-and middle-income countries, we think this is the appropriate model. to construct a model of horizontal fdi, the appropriate price level of output is the local price of the good, not the world price. while input prices have the same effect for horizontal fdi as for vertical fdi, the coefficients on factors that produce trade barriers may now change. trade barriers such as import tariffs, distance to major markets, or lack of access to the sea may act as a deterrent to export-oriented fdi but may actually attract horizontal fdi, since many features that reduce the competitiveness of imports may give fdi that produces for the host economy an advantage. this implies that the coefficients on these variables must again be interpreted with care, since they may be the result of two competing forces. however, for most low-and middle-income countries we expect that fdi will be predominately exportoriented and that the deterrent effect of trade barriers dominates. in our empirical work, we model the gross level of fdi inflows at time t in country i as follows: where the subscript i refers to a country, while t refers to the time period. we include log population (pop) and log gdp per capita as scale variables. following our theory, we also include measures for worker health and education levels as productive components of human capital. further input per capita measures are included in the vector x, while vector z represents barriers to trade that may deter fdi. we include time dummies, d t , to capture changes in the volume of global international investment flows over time (due to changes in the world price or rate of profit), and e represents the error term. we predict that higher levels of health and education inputs are (after controlling for income per capita) associated with lower input costs, p x , according to ( ) above. note that gdp per capita now has two effects in our model. it can not only be considered as a scale variable that captures market size and capacity to absorb fdi, but can also act as a proxy for the overall level of input costs (assuming the cobb-douglas specification above). the two effects of income per capita on fdi can be thought of as generating a coefficient b = (b + b ) on income per capita in our regressions where b represents its scale effect on absorptive capacity and b represents its effect on average input prices. provided the model is correctly specified, there is no problem in estimating the total effect of income per capita (b + b ) though we cannot identify the individual parts of this effect. while this will not affect the validity of our estimation, the coefficient on gdp per capita should be interpreted with caution because it may reflect both the market size and the cost effect that tend to move in opposite directions. note that the market size effect is usually associated with horizontal fdi, while in our model a positive effect of market size on vertical fdi may be due to the economies' ability to absorb fdi inflows without pushing up the price of capital. although our theory is a model of vertical fdi, in practice the estimation is more general and some of the scale effects we detect may reflect horizontal fdi. our estimation approach measures the effect of health on fdi conditional on a number of other factors, such as the scale of the economy and education levels. we therefore estimate only the direct effect of health. there may also be indirect effect. for example, if high levels of population health raise income levels, and reduce mortality, then both income and population numbers will rise. health may also encourage school attendance and education. however, these indirect effects will already be captured by the relevant variables in the model and are not attributed to our health variable. our fdi measure is gross inflows. many researchers use other measures, for example, net inflows, but we prefer gross inflows for three reasons. first, this measure seems more appropriate for investigating what characteristics of a particular country attract investors. second, from eqn. ( ), a capacity constraint on fdi will raise the price of investment as gross inflows increase and some inputs become scarce. third, in terms of knowledge spillovers, which may be a central benefit of fdi, it is the gross inflows that matter and not the net inflows. the literature commonly normalizes fdi flows by dividing by some scale variable, for example, population or gdp. we prefer not to impose a particular normalization or scale factor, instead estimating a relationship. our log formulation allows for normalization by population or gdp as special cases. for example, in the case of population we can transform our equation as follows: it follows that we can test if normalizing by population is a valid method of measuring the scale effect by estimating the original equation and testing the restriction that a = . similarly, normalizing fdi by total gdp gives it follows that our estimated coefficients on health are unchanged by such normalizations. we use life expectancy at birth to proxy the health of a country's population. we would prefer a measure of health that explicitly accounts not only for mortality rates, but also for the morbidity effects of ill-health. however, murray and lopez ( ) demonstrate that higher life expectancy is associated with lower morbidity and overall better health status. furthermore, shastry and weil ( ) report that the survival rate of adult males is linearly related to adult male height, which is often used as a measure of health human capital in microeconomic studies (e.g., savedoff & schultz, ; schultz, ) . these findings establish a relationship between mortality and morbidity measurements. however, health is a multidimensional concept and it is likely that our life expectancy measure does not capture the full complexity of population health. different dimensions of health may have differing economic consequences (e.g., gallup & sachs, , show that endemic malaria affects economic growth, even after accounting for life expectancy). we leave the study of the effects of different components of population health on fdi to future research. we use as our educational stock measure the log of the percentage of the population aged or above who have completed secondary schooling (cohen & soto, ) . we follow the literature with respect to the inclusion of other control variables, including openness of the economy, infrastructure, quality of governance, and distance to major world markets. openness of the economy to trade is especially important for firms seeking to export products from the host country to the global market, as tariffs, quotas, and other forms of capital controls will diminish firms' profits (asiedu & lien, ) . openness is required not only with respect to exports, but also for imports, because many fdi ventures may require the purchase of intermediate inputs from abroad. we employ the ratio of trade (imports + exports) to gdp as our measure of openness. governance is increasingly being identified as a key factor that firms evaluate when choosing to invest abroad (gastanaga, nugent, & pashamova, ; miga & deloitte & touche, ) . in particular, the quality of bureaucratic institutions affects fdi inflows (globerman & shapiro, ; stein & daude, ) . wei ( ) finds that corruption has a strong negative impact on the location of fdi. we use knack and keefer ( ) indexes of bureaucratic quality and corruption in government. note that in both cases a higher value of the index is ''better;'' in particular, a high value of the index indicates less corruption. good infrastructure in the form of transportation and communication networks can increase firm productivity and help attract foreign investment. we employ telephone mainlines per , population as a proxy for host country infrastructure. however, this measure has its limitations, as it only accounts for the availability and not the reliability of the infrastructure. this could be particularly problematic in poor countries where support for infrastructure may be lacking (asiedu, ) . furthermore, telephone mainlines are quickly being replaced by mobile networks. although mobile networks were not sufficiently developed over our study period to be significant, there is evidence to suggest that this is quickly changing (williams, ) . rapid technological changes of this type mean that studies like ours based on historical data need to be treated with caution for policy purposes. we also investigate whether geography affects the distribution of fdi inflows. transportation costs and distance from the home country are commonly included in gravity models of international investment and may affect a firm's decision about where to locate abroad (brainard, ; yigang, ) . although hausmann and fernández-arias ( ) find that distance to major markets is not a robust fdi determinant, we include air distance from major markets as a possible control variable in our analysis. in addition, gallup, sachs, and mellinger ( ) argue that the economies of coastal regions, with their easy access to international trade through sea lanes, should outperform the economies of inland areas. while inland areas can access markets through rail or road links, these are often much more expensive forms of transportation. thus, we include a dummy variable for whether a country is landlocked with the stipulation that the country is not located in western or central europe (countries in western and central europe have close proximity to a major market and the absence of sea routes may not matter). we also include a variable for the proportion of population within km of the coast or an oceannavigable waterway as an alternative to having access to the sea. a weakness of the cross-country approach that we employ is that it relies on national averages. for large countries with major difference across states or provinces, such as india or china, fdi inflows may be responding to local, not national, conditions. in other instances, analysis at the regional level might be more appropriate. for example, parts of southern africa demonstrate a distinctive disease epidemiology partly due to shared ecological and historical characteristics (bloom & sachs, ) . our results therefore carry the qualification that the cross-country approach we employ may need to be supplemented by more detailed local or regional studies to obtain a fuller understanding of the determinants of fdi inflows. the empirical analysis employs panel data for a set of countries observed over the last two decades. a list of countries included in the analysis is provided in appendix a. a summary of data sources and variable descriptions is provided in appendix b. we use all countries for which data are available, but exclude major petroleum exporters, because for these countries our measure of openness (trade flows) may not reflect a lack of trade barriers and gdp per capita is unlikely to proxy labor costs (unctad, ) . the dependent variable, gross fdi inflows, is based on annual data averaged over each decade. we constructed gross fdi inflows using data from the world development indicators (world bank, ) . the world development indicators does not include data on gross inflows directly, but does provide data on total gross flows (the sum of gross inflows and gross outflows) and on net inflows (gross inflows minus gross outflows), from which gross inflows can be derived. we calculated gross fdi inflows using the following two relationships: we multiply this by gdp (constant us$) to obtain gross fdi inflows. all explanatory variables are taken at the beginning of the relevant time period. summary statistics for the full sample are presented in table . the correlation coefficients for the full sample of countries are presented in table . life expectancy ranks second only to gdp per capita in strength of raw correlation to log gross fdi inflows. table shows that life expectancy is highly correlated with income per capita (a correlation coefficient of just above . ). however, while this correlation tends to increase the size of the estimated standard errors in our regressions, it does not undermine the consistency of the estimates or the validity of the inference we can draw assuming that the functional form of our model is specified correctly. table reports our panel data estimates for the full sample of countries with up to two observations per country, one for - and one for - . all reported regressions passed ramsey's regression specification error test (reset) for model misspecification. we estimate using heteroskedasticity-consistent standard errors. column ( ) of table reports results for an ordinary least squares specification that is representative of the fdi literature. the coefficients on income per capita and total population, our indicators of market size, are positive and strongly significant, and this remains true for all our specifications. the coefficients on each are usually not significantly different from unity in our regressions, indicating that in practice normalizing fdi flows by total gdp is valid. corruption is not significantly different from zero in our specifications, yet the other gover- nance measure, quality of bureaucratic institutions, is both significant and positive in the model. adding life expectancy in column ( ) demonstrates that health is a statistically significant predictor of gross fdi inflows at the % level and is robust to adding education in column ( ). the results indicate that every additional year of life expectancy increases fdi inflows by about % among the full sample of countries. the other component of human capital, education, has a positive coefficient, but is not statistically significant. this finding is consistent with the conflicting evidence on the importance of education in determining the inflows of fdi. root and ahmed ( ) , as well as schneider and frey ( ) , report that education does not significantly affect fdi flows to developing countries. more recently, however, noorbakhsh et al. ( ) and globerman and shapiro ( ) argue that education does have a positive and significant impact on foreign investment and that its effect has been increasing over time. the reason for the poorly determined coefficient on secondary schooling in our model could be measurement error in the data on education that biases the estimated coefficient toward zero (see krueger & lindahl, ) . we also tried other measures of education, such as the number of accumulated years of education in the population aged - and school enrollment rates, but did not find any measure that produced a statistically significant effect. we further test for robustness by adding infrastructure and geographic variables that are also postulated to be determinants of fdi inflows. the results reported in column ( ) indicate that the coefficient on life expectancy is robust to these alternate specifications, though many of the controls do not themselves appear to be statistically significant. recent evidence suggests that pooling data from industrial and developing countries in empirical fdi studies may yield misleading coefficient estimates (blonigen & wang, ) . we might expect that developing countries are more dependent on export-oriented fdi, while industrial countries are more attractive for market-seeking fdi (shatz & venables, ) . of particular relevance to the current study, we noted a gap in average life expectancy between income groups: . years for high-income countries versus . years for low-and middle-income countries. diminishing returns to health might well make it a more important investment in low-income countries. we therefore analyze the model using two restricted samples, one of low-and middle-income countries and one of high-income countries selected on the basis of the world bank's income classification. the results for low-and middle-income countries are reported in table . the model being estimated in table is identical to that reported in table , the only difference being the sample. the results are broadly similar to those listed in table . the coefficient on openness is somewhat larger than before, which is consistent with foreign investment to developing countries being mainly export-oriented. life expectancy once again has a positive and statistically significant effect on fdi. the large decrease in the coefficient on gdp per capita when we add life expectancy to the model indicates that when health is excluded from the model, gdp per capita is, to some extent, serving as a proxy for health in low-and middle-income countries. the effect of population health on fdi inflows is robust to adding education and other control variables. our results suggest that every additional year of life expectancy is associated with a % increase in gross fdi flows to lowand middle-income countries. the index of corruption is now significant, but of the ''wrong'' sign. the results suggest that higher levels of corruption are associated with higher levels of fdi in low-and middleincome countries. this finding, although perhaps surprising, agrees with stein and daude's ( ) and wheeler and mody's ( ) results. it is also consistent with alesina and weder ( ) , who argue that the relationship between corruption and economic performance is complicated. some types of corruption may allow the relatively efficient provision of services to foreign firms, its main effect being on the distribution of domestic economic gains, with little distortion of productive activities. table uses the same specifications as table for a sample restricted to high-income countries. the sample size now becomes quite small and may lead to some variables becoming statistically insignificant simply because of a lack of power; therefore, these results should be treated with caution. unlike the results reported from the previous two samples; openness, gdp per capita, and bureaucratic quality are not statistically significant. the lack of significance of openness is consistent with the idea that fdi going to industrial countries is mainly to access their markets rather than to export. even though gdp per capita does not have a significant association with fdi inflows, the other proxy for market size, total population, is highly significant at the % level. the lack of significance of gdp per capita could be due to a balancing of the market size effect with the cost of production effect, which should work in the opposite directions. reduced corruption does appear to have a positive and significant impact on fdi in this sample; indicating that the type of corruption, or the way it affects the economy, may differ between industrial and developing countries. health is not statistically significant in any specification among high-income countries. this is consistent with the idea that the worker productivity effects of health differentials appear mainly in developing countries; however, we hesitate to emphasize such an interpretation due to the small sample size. our results are consistent with those of blonigen and wang ( ) , who argue that the underlying factors that determine the level of fdi activity vary systematically across countries at different stages of development. this split of the sample is supported by the fact that we can reject parameter equality between the two sub-samples in some specifications. for example, taking regression , the f-test (distributed as a v ( , )) yields a statistic of . . this leads us to reject the hypothesis that the coefficients reported in the two sub-samples are the same at the % significance level. we also reject the commonality of coefficients in regression specification . although we fail to reject the null hypothesis of equality for regression specifications and , it seems preferable to consider the two sub-samples separately. this paper provides empirical evidence that health is indeed a positive and statistically significant determinant of gross fdi inflows to low-and middle-income countries. our results remain robust to adding many control variables, such as education, governance, infrastructure, and income per capita. although we have tried to ensure that our results are robust, there is always the possibility that some hidden variable is the real determinant of fdi. the positive coefficient on life expectancy may be due to factors correlated with health that we could not control for in the model. future studies should confirm the robustness of our findings and attempt to disaggregate the health effect we have identified. it may be that certain diseases have a greater impact on fdi inflows than others. for example, diseases that afflict the working-age population (e.g., hiv/aids) or are easily transmittable (e.g., tuberculosis) may deter fdi inflows more than chronic, non-communicable diseases. perhaps diseases with a high morbidity affect fdi differently than those with a high mortality. it is difficult to carry out this type of detailed analysis at the cross-country level, but it may be possible in more local settings. despite these qualifications, our main result is that a one-year improvement in life expectancy is associated with a % increase in gross fdi inflows to low-and middle-income countries, and this result seems fairly robust. these findings are consistent with the view that health is an integral component of human capital for developing countries and suggest that the payoff to improved population health is also likely to include an elevated rate of fdi inflows. notes . globerman and shapiro ( ) do regress fdi on the human development index (hdi), which is a composite of gdp per capita, educational literacy and enrollment, and life expectancy at birth. we directly investigate the effect of health on fdi. . in , the five highest fdi-receiving countries attracted % of the total inflows to the developing world (cho, ) . . for example, debswana, anglo american, and coca-cola are a few companies now subsidizing hiv medicines (anti-retroviral therapy) in southern african countries (the economist, ) . . more generally, acemoglu, robinson, and johnson ( ) show that historically infectious disease burdens have had a profound impact on the pattern of colonial settlement while glaeser, la porta, lopez-de-silanes, and shleifer ( ) emphasize that one effect of such settlement was the transfer of human as well as physical capital. . the profit function assumes that all factor inputs are chosen to maximize profits given the price vector. in our case we examine the profits earned by a unit of fdi, allowing all other inputs to be chosen optimally. . adding multiple inputs in the same cobb-douglas function does not change any of the results. . the estimates of life expectancy are based on agespecific mortality rates for high-income countries but are usually constructed from life tables based on infant mortality rates from national demographic and health surveys in developing countries (see bos, vu, & stephens, ) . . williams ( ) finds that mobile phone penetration rates are a significant and positive predictor of net fdi inflows to developing countries. however, these results are only observed for the period - . a similar relationship is not found if data from to are included in the analysis. williams interprets these findings as evidence that mobile networks were not sufficiently developed during the earlier period to affect fdi. . the sea distance may be a better indicator than air distance to major markets for trade purposes, though this leaves open the issue of how to deal with landlocked countries. . the major petroleum producers are algeria, angola, bahrain, brunei darussalam, republic of congo, gabon, indonesia, islamic republic of iran, iraq, kuwait, libyan arab jamahiriya, nigeria, oman, qatar, saudi arabia, syrian arab republic, trinidad and tobago, united arab emirates, venezuela, and yemen (based on the classification by the united nations conference on trade and development-see http://www.unctad.org/templates/webflyer.asp?intite-mid= &lang= ). . because data are not available for , we used the earliest available data (during - ) for the index of corruption and quality of bureaucratic institutions over both time periods. the data for the variable, ''percent of population kilometers from the coast or an ocean-navigable waterway,'' are estimated using geographic information system (gis) technology, which does not date back to . despite this limitation, the variable was included in the model as a determinant of trade costs. we also tried other geographic variables (e.g., land area in the tropics) but none were significant. . neither the share of the population near the coast nor being landlocked were significant if entered separately. . in the world bank ( ) categorization, the lowand middle-income group (all developing economies) includes those countries in which the gross national income per capita was us$ , or less, as measured in current us dollars. the 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( ) key: cord- -idvf rs authors: umucu, emre; reyes, antonio; carrola, paul; mangadu, thenral; lee, beatrice; brooks, jessica m.; fortuna, karen l.; villegas, diana; chiu, chung-yi; valencia, carolina title: pain intensity and mental health quality of life in veterans with mental illnesses: the intermediary role of physical health and the ability to participate in activities date: - - journal: qual life res doi: . /s - - -y sha: doc_id: cord_uid: idvf rs purpose: the purpose of this study was to examine the intermediary role of physical health quality of life and ability to participate social roles and activities in the relationship between pain intensity and mental health quality of life in veterans with mental illnesses. methods: this is a cross-sectional correlational design study. our participants are veterans with self-reported mental illness (m(age) = . ; sd(age) = . ). descriptive, correlation, and mediation analyses were conducted for the current study. results: pain intensity was negatively correlated with physical health qol, ability to participate in social roles and activities, and mental health qol. physical health qol and ability to participate in social roles and activities were positively associated with mental health qol, respectively. physical health qol was positively correlated with a ability to participate in social roles and activities. study results indicate that the effect of pain intensity on mental health qol can be explained by physical health qol and ability to participate. conclusions: specific recommendations for practitioners include implementing treatment goals that simultaneously focus on physical health and ability to participate in social roles and activities for clients who present with both physical pain and low mental health qol. due to the intense experiences associated with deployment and combat, veterans are at high risk of developing a mental illness [ ] . more than . million veterans received treatment in a department of veterans affairs (va) mental health specialty program in fiscal year [ ] , and this number may not fully reflect the problem of mental illness among veterans given that many do not seek treatment through the va [ ] . mental illness is associated with poorer mental health quality of life, which is comprised of a combination of the perception of mental health and functional effects of mental illness [ ] . mental health quality of life provides a useful understanding of the burden of mental illness because it appreciates that the impact of mental illness may be variable among individuals. additional research is needed to better understand predictors of mental health quality of life and well-being for veterans with a mental illness [ , ] . veterans are also at high risk of developing chronic pain due to the extraordinary physical stress associated with military service [ ] . studies indicate that % of veterans report experiencing pain with % reporting severe pain [ ] . over % of veterans who receive care at the va are diagnosed with musculoskeletal pain [ ] and a survey of veterans found a high prevalence of headaches ( %), joint pain ( %), back pain, ( %), muscle pain ( %), and abdominal pain ( %) [ ] . researchers argue that addressing and treating pain, including addressing opioid use disorder (oud) risk, is an increasingly important challenge for the va due to the aging population and growth in number of veterans with chronic pain related to recent military service [ ] . prior studies also indicate that veterans with chronic pain and comorbid psychiatric disorders are more likely to receive opioids than pain patients without comorbid psychopathology, these diagnoses are also associated with prescription of high opioid doses [ ] . for veterans who experience pain, the effects can extend to every aspect of their life. pain can interfere with participation in daily activities and is associated with higher levels of emotional distress [ ] . thus, it is not surprising that pain and mental illnesses are commonly comorbid for veterans [ ] . research suggests that pain is strongly associated with symptoms of anxiety, depressive disorders, suicidal ideation, and ptsd [ ] [ ] [ ] . poundja et al. [ ] found that both pain severity and pain interference are negatively correlated with mental health quality of life in canadian veterans suffering from traumatic stress. boakye et al. [ ] examined healthrelated quality of life in veterans with spinal cord injury (sci) and found that a visual analog pain score was the most important predictor of worsened mental health quality of life scores. likewise, kazis et al. [ ] reported that chronic low back pain is negatively associated with mental health quality of life in patients served by the va. these studies and others highlight the importance of better understanding the underlying mechanisms by which pain intensity impacts mental health quality of life for veterans. mental health quality of life and pain are also associated with physical health quality of life (i.e., ratings of physical health and the ability to carry out physical activities) and participation in social roles and activities. the ability to participate in social roles and activities improves mental health while decreasing mental health symptoms [ ] . social participation is also strongly associated with social support, which has long been known to play an important role in protecting against negative effects of stress and mental illness, see e.g., [ ] . research suggests that physical health quality of life is associated with greater ability to participate in social activities, and consequentially enhancing social connectedness and its health benefits. for example, longitudinal data from the veterans health study, ren et al. [ ] shows that physical health is associated with a person's ability to participate and maintain social relationships and stronger social support. additionally, rippentrop et al. [ ] found that physical health quality of life is positively related to mental health quality of life for individuals with chronic pain. similarly, in a study of vietnam veterans, schnurr et al. [ ] found that reported physical health quality of life is related to ptsd symptom severity. general population studies also indicate that greater pain intensity is associated with greater interference with social participation and physical and recreational activities [ ] [ ] [ ] . in a study of veterans, naylor et al. [ ] found a positive correlation between pain intensity and functional factors including physical disability and social support. overall, research supports that pain, physical health quality of life, and the ability to participate in social functions are all related and contribute to mental health quality of life. likely, the relationship between pain intensity and mental health quality of life is influenced by physical health quality of life and participation in social roles and activities. although existing studies have examined the relationship between pain, social relationships, and physical and mental health quality of life for veterans, none have systematically examined these factors together to better understand their impact on mental health quality of life. therefore, the purpose of this study was to examine the intermediary role of physical health quality of life and ability to participate in social roles and activities in the relationship between pain intensity and mental health quality of life in veterans with mental illnesses. we hypothesized that (a) increased pain intensity is associated with reduced physical and mental health quality of life, (b) decreased physical health quality of life is associated with lower levels of the ability to participate social roles and activities, and (c) reduced ability to participate social roles and activities negatively affect mental health quality of life in veterans with mental illnesses. health care systems could use this valuable information to potentially improve value of services for veterans with mental illnesses by addressing modifiable risk factors such as physical health qol and ability to participate through treatment. this cross-sectional study was reviewed and approved as an exempt study by the institutional review board by the university of texas at el paso. we collected data from amazon's mturk, a crowdsourcing tool enabling mturk workers to access and complete human intelligence tasks (hits). mturk has been considered as a valid, diverse, reliable, and cost-effective large data collection tool [ , ] . based on mturk options, we restricted participants to be residents in the united states who have military experience. we shared a qualtrics survey link with participants. all participants read an online consent form and agreed to be participant in this study. all participants received $ . upon completing the online survey. pain intensity was assessed using the promis ® numeric rating scale v. . -pain intensity a [ ] [ ] [ ] . it is a oneitem measure that asks respondents to rate their pain on average, ranging from (no pain) to (worst imaginable pain) over the past days. higher scores indicate higher levels of pain intensity. physical health qol was assessed using the promis ® scale v . -global health physical a [ ] . it is a -item measure that asks respondents to rate their physical health (ranging from [poor] to [excellent]) and their ability to carry out daily physical activities (ranging from [not at all] to [completely]). higher scores indicate higher physical health qol. total raw scores were converted into t scores. the cronbach's alpha coefficient for the promis global physical health in the present study was computed to be . . ability to participate was assessed using the promis ® item bank v . -ability to participate in social roles and activities-short form a [ ] . it is a -item measure that asks respondents to rate their perceptions on their ability to perform their social functions, ranging from (always) to (never). higher scores indicate higher levels of ability to participate. total raw scores were converted into t scores. the cronbach's alpha coefficient for the promis ability to participate in social roles and activities in the present study was computed to be . . mental health qol was assessed using the promis ® scale v . -global health mental a [ ] . it is a -item measure that asks respondents to rate their mental health and satisfaction with social connections, ranging from (poor) to (excellent). higher scores indicate higher mental health qol. total raw scores were converted into t scores. the cronbach's alpha coefficient for the promis global mental health in the present study was computed to be . . all analyses were performed using the statistical package for the social sciences (spss; version ). descriptive statistics were computed to provide information about the demographic characteristics and for the independent variable, mediators, and dependent variable. correlation analysis was conducted to examine relationships among variables. finally, a serial mediation analysis was conducted to examine physical health qol and ability to participate as mediators between pain intensity and mental health qol. the spss process . . [ ] was used to conduct mediation analysis. a bootstrapping approach was also used to test the significance of indirect effects of pain intensity on mental health qol with bootstrap samples through (a) physical health qol, (b) ability to participate in social roles and activities, and (c) both physical health qol and ability to participate. although there is not a consensus how many bootstrap samples should be generated, researchers recommended at least resamples for final reporting [ ] . the total number of participants were veterans with selfreported mental illnesses. participants ranged in age from to , with an average of . years old (sd = . ). most participants were males ( . %). the majority of participants identified as caucasians ( . %) and married ( . %). regarding educational level, % obtained a bachelor's degree, followed by some college credit without a degree ( . %), an associate's degree ( . %), a graduate degree ( . %), a trade/technical/vocational training ( . %), and a high school degree ( . %). many participants served in the army ( . %), followed by air force ( . %), navy ( . %), marine corps ( . %), and coast guard ( . %). in terms of mental illnesses, participants reported at least one type of mental illnesses, including . % reported depression, . % reported anxiety, . % reported ptsd, . % reported substance use disorder, . % reported bipolar disorder, . % reported personality disorder, and . % reported others. participants' pain intensity scores ranged from to with an average of . after examining t scores, we found that . % and . % of the participants had physical health quality of life t scores of above and below the mean, respectively; . % and . % of the participants had mental health quality of life t scores of above and below the mean, respectively; and . % and . % of the participants had ability to participate in social roles and activities t scores of above and below the mean, respectively. pain intensity was negatively correlated with physical health qol (r = − . , p < . ), ability to participate in social roles and activities (r = − . , p < . ), and mental health qol (r = − . , p < . ). physical health qol (r = . , p < . ) and ability to participate in social roles and activities (r = . , p < . ) were positively associated with mental health qol, respectively. physical health qol was positively correlated with an ability to participate in social roles and activities (r = . , p < . ). the serial mediation model is presented in fig. . pain intensity was significantly associated with mental health qol (c = − . , p < . ). pain intensity was significantly associated with physical health qol (a = − . , p < . ) and was significantly associated with ability to participate in social roles and activities after controlling for physical health qol (a = − . , p < . ). physical health qol was significantly associated with ability to participate in social roles and activities after controlling for pain intensity (d = . , p < . ). additionally, physical health qol was significantly associated with mental health qol after controlling for pain intensity and ability to participate in social roles and activities (b = . , p < . ). ability to participate in social roles and activities was significantly associated with mental health qol after controlling for pain intensity and physical health qol (b = . , p < . ). importantly, pain intensity was no longer significantly associated with mental health qol after controlling for physical health qol and ability to participate in social roles and activities (c′ = . , p = . ). this suggests that physical health qol and the ability to participate in social roles and activities mediated the relationship between pain intensity and mental health qol. in addition, results using the process with bootstrap samples, demonstrated that the indirect paths were significant because the % confidence intervals did not contain zero, suggesting that the indirect effects were different from zero. the indirect effect of pain intensity through physical health qol on mental qol was significant (a our analyses provide novel insights by clarifying the intermediary role of physical health quality of life and ability to participate in social roles and activities in the relationship between pain intensity and mental health quality of life in veterans with mental illnesses. similar associations were found between pain intensity and physical health qol, ability to participate in social roles and activities, and mental health qol, respectively. however, one key finding is that the initial association between pain intensity and mental health qol was mediated by physical qol and ability to participate in social roles and activities. this is valuable information because the negative effect of pain on mental health qol could be mitigated by increasing physical health qol and ability to participate in social roles and activities and potentially improve value of services for veterans with mental illnesses by addressing these modifiable risk factors through treatment. physical health qol and ability to participate in social roles and activities directly contribute to veterans' level of pain and mental health independently. as such, reduced mental health symptoms in veterans who also have identified pain symptoms can be achieved through improving physical health and ability to participate in social roles and activities in veterans with mental illnesses. strategies to improve physical health and ability to participate in social roles and activities are effective treatment supplements for rehabilitation and mental health professionals to integrate into their psychotherapeutic or psychoeducational interventions for veterans with mental illnesses who have low mental health qol due to pain intensity. in addition, increasing evidence is accumulating for the effectiveness of multidisciplinary pain management strategies [ ] [ ] [ ] [ ] [ ] , including the va's own stepped care pain management approach, to manage severe chronic pain [ ] . supplementing traditional psychotherapeutic or psychoeducational pain management interventions with self-directed client activities constitutes an empirically supported approach to treatment. this approach is supported by recent research that has highlighted the importance of self-managed (i.e., initiated and managed by the client) interventions [ ] . in their study, harding et al. [ ] found that while veterans with chronic pain psychological comorbidities were more likely to seek provider managed interventions, they were more likely to use self-managed interventions overall. this suggests that veterans are more willing to initiate self-managed interventions for chronic pain in general. self-managed interventions can also be implemented through more direct ways through integrated primary and behavioral health care, see e.g., [ ] . the specific relationships between pain intensity, mental health, physical health, and ability to participate in social roles and activities are central data that inform integrated treatment practices. this study provides important evidence that supports the argument for both multidisciplinary assessment and treatment. while multidisciplinary and holistic models of treatment have long been advocated in the mental health profession [ ] , the direct relationship between physical health and ability to participate in social roles and activities with patient's experienced pain provided by this study supports the benefit of physical health and ability to participate in social roles and activities as our study provides the promising approach to complement the existing services. these factors could also be used to better guide future studies and clinical trials from the newly developed pain management collaboratory [ ] , which has the main goal of developing the capacity to implement cost-effective large-scale pragmatic clinical research in military and veteran health care delivery organizations focusing on nonpharmacological approaches to pain management and other comorbid conditions. the value of this study is highlighted by the overall lack of research directly exploring the relationships between pain intensity, mental health, physical health, and social engagement. historically, medical and mental health treatment have been viewed by health care and policy makers as separate [ ] , which has created barriers for overall treatment and negatively impacts help seeking behaviors for persons with both medical and mental health concerns. this is specifically relevant for veteran populations who have experienced increased rates of mental health disorders [ ] and high rates of comorbidity between pain and mental health diagnoses [ , ] . the results of the current study not only support the importance of mental health professionals using holistic interventions but also supports previous research that cites the benefit of integrated behavioral and primary healthcare, see e.g., [ , ] . although there is a lack of research examining the intermediary role of physical health qol and ability to participate in social roles and activities for the relationship between pain intensity and mental health qol among veterans, it is also important to report that our findings are partially consistent with some studies with different populations. for example, participation restriction was found to be a mediator between pain intensity and depression symptoms and qol in individuals with spinal cord injury, respectively [ ] . nguyen et al. [ ] examined whether changes in mental health was associated with improvements in pain and function scores year after total hip arthroplasty. their findings revealed that greater improvements in pain and function were related to greater improvements in mental health. in a sample with chronic low back pain, authors [ ] reported that higher somatic symptoms were related to lower healthrelated qol independent of depression and other comorbid disorders [ ] . interestingly, in a sample with chronic pain, authors [ ] found that pain intensity and duration were found to have a minor role for qol and disability although psychological variables (e.g., depression) were found to have a strong association with qol and disability. overall, these findings revealed that pain-related, psychological, and social factors are important for qol although the magnitude of impacts of these variables on qol may change based on the population. as indicated above, it is important to have holistic and multidisciplinary treatment options to achieve optimal rehabilitation and health outcomes, which could eventually improve qol. additionally, as this manuscript is being written, the u.s. is facing a global pandemic from the covid- virus. the physical and social restrictions brought on by this pandemic limit social participation and is negatively impacting the mental health quality of life for all persons and may have elevated effects for groups that are already experiencing physical and mental health issues. besides, the current covid- pandemic has led to changes in mental health care (e.g., transition to telehealth service delivery), disruptions in daily life, and greater psychological distress that are unique to veterans [ , ] . since many veterans may already experience social isolation and activity restrictions, it is especially important to facilitate discussions around maintaining and improving positive social connections while following social distance measures, encourage the use of adaptive coping strategies to manage difficulties, and provide psychoeducation on how the covid- pandemic might trigger trauma-related memories [ ] . our study provides further implications for clinicians to consider when working with veterans with mental illnesses in the covid- crisis. for instance, clinicians may take veterans with mental illnesses' physical health qol and ability to participate into consideration as the pandemic may have led to dramatic shifts in veteran's daily life, which can further influence their mental health quality of life. during a public health crisis as such, veterans with mental illnesses may benefit from individualized treatment plans that are tailored to their personal and contextual factors. some limitations of this study will need to be addressed by future research. first, our design is incapable of evaluating the causal mechanisms that underlie the explored relationships. future studies should utilize longitudinal designs to explore the temporal associations of these variables. nevertheless, these findings provide important information that could ultimately improve the value of clinical services already available for veterans with mental illnesses. second, data for this study come primarily from veterans with heterogeneity of self-reported mental illness. therefore, since different mental illnesses have different underlying pathophysiological mechanisms, associations could change by exploring mental illnesses separately. third, in addition to pain intensity, future studies should explore pain interference, which is defined as the extent that pain negatively impacts engagement in social, cognitive, emotional, physical, and recreational activities. fourth, female veterans seem to be slightly over-represented in our sample and the percentage of subjects with a bachelor's degree seems to be higher than the average in veterans ( . - . %) [ ] . fifth, we measured pain intensity with a single item. given the complexity of pain and its impact on qol (e.g., pain and mental health and physical health relationships), future studies may consider measuring pain intensity with a scale that has a strong evidence of discriminant validity. finally, it is important to take into consideration that there may be some conceptual overlap between the concepts examined in our study, which we suggest that future research should use more robust means of measurements. in summary, these findings support continued efforts to provide multidisciplinary, holistic and integrated health care for the management of pain conditions for veterans with mental illnesses. specific recommendations for practitioners include implementing treatment goals that simultaneously focus on physical health and ability to participate in social roles and activities for clients who present with both physical pain and low mental health qol. while many practitioners may use patients' levels of physical health and social engagement as a measure to predict 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implications for managing parenting stress during covid- aging veterans' mental health and well-being in the context of covid- : the importance of social ties during physical distancing profile of veterans: data from the american community survey we would like to thank renee viramontes and cherylanne hunter for their support in our lab, the veteran vvell-being lab (v ). key: cord- -h sxkqw authors: cheng, yang; cheng, feng title: china's unique role in the field of global health date: - - journal: global health journal doi: . /j.glohj. . . sha: doc_id: cord_uid: h sxkqw abstract china's participation in global governance, inspired by the united nations sustainable development goals, is driven by the guiding principle of “building a community of shared future for mankind”. china has been promoting the belt and road initiative and south-south cooperation and has made significant contributions to the prosperity of human beings. along with the opportunities that globalization brought about such as the world health organization and the boom in the economy, global health challenges also emerged. this resulted in certain obstacles for china when it sought to advocate the belt and road initiative and when it attempted to carry out its strategy to address global health issues. what are the emerging challenges for global health? what can china do for global health? why does global health need china? we tried to address these questions as china's global engagement continues to expand in the new era. this article makes the case for chinese approaches, including getting involved in public health, being consistent in addressing local conditions, sharing china's experience with handling health services, and strengthening government-led action while being guided by relative policies. china has a lot to offer in the promotion of global health and in overcoming the challenges and risks that this goal currently faces. thus, china should be considered an inseparable part of global health governance and bilateral health development cooperation. consistent with its emphasis on promoting global health, china follows the norm of "building a community of shared future for mankind", which operates as a guiding principle for china when it participates in global governance, as proposed by chinese president xi jinping, in keeping with the united nations (un) sustainable development goals (sdgs) to be achieved by . when the un millennium development goals (mdgs) were terminated in , un member states arrived at a consensus and adopted the sdgs and targets at the un general assembly in september . the third sdg aims to promote "good health and well-being". all targets under it are directly related to health. there are two concrete measures that have been proposed to build a community of shared future for mankind in the new era. the first is to advocate the belt and road initiative that seeks to share china's experience and wisdom with the world, to promote global peace and cooperation, and to engage in joint development endeavors. by the end of , china had signed intergovernmental cooperation documents with countries and international organizations, which widened the circle of friends for the belt and road initiative and included parts of asia, africa, europe, oceania, and latin america. the second initiative is to continue deepening south-south cooperation. china attaches great importance and is committed to its cooperation with other developing countries. in september , president xi announced the establishment of an assistance fund for south-south cooperation at the un sustainable development summit that he hosted at the un. he also stated that china would continue to increase its investments in least developed countries in the world and set up the center for international knowledge on development to provide new ideas, models, and impetus for south-south cooperation. during his visit to africa in december , president xi proposed the china-africa cooperation -"going forward hand in hand, cooperating with a win-win strategy, and developing with each other"-and pledged to provide usd billion to support major cooperation plans across africa. thus, china will continue to play its role as a responsible country and work with other countries to create a better future for mankind. globalization is a double-edged sword. when money is allowed to flow freely, the possibility of a global economic crisis becomes higher. the international health system is centered on each nation and state, and health global health journal j o u r n a l h o m e p a g e : h t t p : / / w w w . k e a i p u b l i s h i n g . c o m / e n / j o u r n a l s / g l o b a l -h e a l t h -j o u r n a l / problems encountered by each country are defined by its borders. the resolution of these health problems typically requires cooperation among multiple countries through measures that include customs quarantine and restrictions on the spread of colonial tropical diseases. the health sector in each country is primarily responsible for resolving these problems, and operates with "sharp divisions" among countries. the world health organization (who) is undisputedly the leading coordinator of its member countries. with globalization, health risks began to cross national boundaries. as the power of non-state actors rises and the participation of non-health sectors in the health sector expands its scope, diverse global forces cooperate to respond to national and global health problems. the who is one of these forces. the prevailing situation has precipitated existing global health initiatives. effective global health initiatives should: ( ) cross borders by promoting global health research aimed at breaking national territorial boundaries and focusing on the health of the global population; ( ) be interdisciplinary by solving these health problems using knowledge from many other disciplines and through interdisciplinary collaboration; and ( ) fully motivate various actors by identifying the global forces that need to be motivated to address health problems. global health emphasizes solutions that utilize a variety of cross-border cooperative actions. global health also poses security issues for countries. the rapid movement of people, goods, capital, technology, ideas, and cultures among different countries has resulted in unprecedented development opportunities and enormous public health challenges. emerging infectious diseases such as ebola, middle east respiratory syndrome (mers), and avian flu are on the rise and are changing constantly. traditional infectious diseases such as tuberculosis, malaria, and aids are resurfacing and spreading. as a result of the increasingly serious abuse of antibiotics, the types of multidrug-resistant pathogens have also increased. [ ] [ ] [ ] as people's behaviors and lifestyles have changed, the chronic non-communicable diseases have become more common in developing countries. the dual burden of infectious and non-communicable diseases is a pressing issue. in , million chinese citizens went abroad to travel, work, and/or study. tourist arrivals in china totaled million. the length of china's inland borderline is over , km and the border area accounts for about % of the country's total area. along this line, there are counties spread over provinces of china, and the outer boundary borders more than countries. along china's border, the northern border of china has a large population density, while the southern border has a small one. compared with the border areas outside china, there is greater population density in the northeast and northwest parts of chinese frontier regions, which is much less in southwest frontier regions. the population number in china's border areas is very low, and its density of the border areas outside china is even lower than that of inside china's frontier. population decline is a major feature of the border areas in recent decades. for example, in the northwestern border areas between china and russia and between china and mongolia, the concentration of population decreased. the population decreased significantly in china's northeastern frontier regions with north korea, and in the china's southwestern regions and its neighboring countries. the belt and road initiative requires the successful implementation of global health, although there are some challenges: ( ) the types of infectious diseases vary greatly in countries along the belt and road; ( ) health monitoring and management for hundreds of thousands of chinese engineers involved in the belt and road infrastructure will be difficult; and ( ) the main infrastructure projects are primarily implemented in major cities, ports, and transport hubs. to ensure the security and convenience of cooperation for global health and the influence and radiation effects of its relative projects, the layouts of funded hospitals, disease control and prevention centers, and medical laboratories should adopt some strategies. china's economic growth is closely tied to its role in the world. its health development is expected to have worldwide influence. the investment and scale of china's global strategy for health will affect the global stakeholders and their diplomatic policies. china has always been a strong supporter of and practitioner in the field of global health. since , china has been sending medical teams to more than developing countries in africa and other parts of the world. in recent years, china has created the association of southeast asian nations (asean) public health fund, actively participated in health cooperation efforts between the asia-pacific economic cooperation (apec) and the shanghai cooperation organization (sco), and hosted the first health ministers' meeting of the brics countries (brazil, russia, india, china, and south africa) in . china also contributed to the global fund to the extent of usd million by , hosted a fundraiser for avian influenza prevention and control in , and donated usd million to un agencies toward addressing global health issues. after becoming the sixth largest contributor to the un in , china continued to increase the extent of its voluntary contributions to the who and unaids. china is also a member of the decision-making body and expert advisory group at the who, unaids, and other major international organizations. with abundant experience in fundamental medical and healthcare systems, china can be a role model for other developing countries. china's new rural cooperative medical insurance has expanded significantly. in the past decade, china increased the coverage of basic medical insurance in rural areas from % to %. michel sidibé, the executive director of unaids, said that the un is learning from the experience of the barefoot doctors of china who are a part of the basic medical insurance initiative in china, and that the un is planning to train million community health workers in africa by . with a severe shortage of grassroots doctors and the difficulty in retaining talent, the tanzanian government has shown high interest in the barefoot doctors program. china has extensive experience in training barefoot doctors. many rural doctors are local villagers and serve the local area. this model may be useful for other countries that experience a shortage of talent. china's infant mortality rate (imr) dropped from . ‰ in to . ‰ in , and the maternal mortality rate dropped from . per , persons in to . per , persons in . by , china achieved the global tuberculosis (tb) control target set by who, with at least % detection rate and successfully treating more than % of those patients. china has eliminated lymphatic filariasis, malaria, and schistosomiasis, and implemented a national immunity program; it currently provides free vaccinations to prevent types of diseases that include vaccines for diseases and vaccines for hepatitis b. all great achievements in public health in china has been supported by solid technologies such as the development of vaccines and drugs, portable ultrasound detection equipment, fetal monitoring equipment, diagnostic reagents, the shang ring, artemisinine, and subepidermal contraceptive implants. concurrently, china is also a major producer of medicines and medical facilities. with reliable quality and reasonable pricing, medicaments developed and produced in china have drastically supported its public health services. using only % of the world's health resources, china successfully meets the health demands of % of the world's population. in march , during the first session of the th national people's congress of china, the proposal to reform the state council and establish the china international development cooperation agency (cidca) was passed, which officially opened on april , . the agency's primary responsibilities include: ( ) developing foreign aid strategies, plans, and policies; ( ) coordinating major foreign aid issues; ( ) offering suggestions, promoting reforms of foreign aid models, formulating foreign aid programs and plans; and ( ) supervising and evaluating the implementation of foreign aid projects. aiming to create a new type of public health aid team and build its capacity by setting up an expert-steering committee, it is very necessary to build a talent pool and offer specialized training. meanwhile, developing a guideline on international public health development and cooperation is also helpful. measures include writing official documents on public health in english, developing and managing international public health development cooperation projects, establishing relevant overseas project departments, and respecting the ethics, etiquette, and culture of international public health development and cooperation. in addition, it seeks to ensure the stability of overseas public health work and the implementation of public health projects, improving communication and negotiation skills used in international public health development cooperation, and understanding international public health strategies. to improve china-africa cooperation in public health, there could be a variety of ways, including regularly communicating and discussing relevant topics, short-term training ( days) and further study ( months) programs for the belt and road countries in africa, holding seminars, and sending experts to introduce the international public health development aid and enhance capacity to participate. china's public health aid capacity building projects are solidly supported by the chinese center for disease control and prevention (china cdc). first, with the expansion of globalization, world trade, migration, and international exchange activities, global health has become an increasingly important agenda worldwide and for individual countries, as it is closely related to national security, diplomacy, economy and trade, agriculture, and environment. given the outbreak of emerging and re-emerging communicable diseases in recent years and the public health measures included in many countries' national security strategies, the risk of transnational spread of diseases should also be considered in the course of strategy-and policy-making efforts, training talents, and developing projects. second, the world has increasingly high expectations for china, given its peaceful rise and growing power. president xi has shown a positive attitude and has promoted strong efforts to help african countries and to participate in global health initiatives. these include commitments announced at the un general assembly and the summit of the forum on china-africa cooperation to support public health policies and strategies of african countries, and to help them optimize their public health prevention systems. as the infrastructure and capacity of health systems in african countries are weak, especially in west africa which is still recovering from the ebola epidemic, the establishment of public health systems and the cultivation of talents become crucial. this provides an opportunity for china to make progress in public health assistance in terms of public health aid, the construction of talent teams, and the establishment of an external supporting environment. it is particularly urgent and necessary to train a team of competent experts and to design a reasonable top structure for cooperative public health projects such as the construction of the african center for disease control and prevention (africa cdc) and the establishment of the west african center for tropical disease research and control in sierra leone. third, among the chinese government's current practices in the field of foreign aid for health, public health aid is still in its early stages. medical assistance in response to the ebola outbreak in west africa in was the largest foreign public health assistance thus far and revealed numerous problems in policy, management, and fundraising. the process of designing and conducting this project improved drastically and stimulated the completion of china's foreign health aid policies and practices by improving and enriching the policies, mechanisms, teams, practices, and guidelines for public health aid. fourth, the china cdc is a leading public health institution in china, and an important technological force in foreign public health assistance. it is responsible for assisting in the ebola epidemic in west africa, the construction of the africa cdc, the technological cooperation with the p laboratory in sierra leone, and the control and prevention of malaria. it has accumulated vast expertise in medical aid. the design and implementation of this project is consistent with the chinese government's commitments to foreign health assistance and china's strategic development goals. however, to meet the needs of public health assistance in the new era, it is necessary to comprehensively and systematically develop and improve the construction of institutions, mechanisms, modes of cooperation, and the capacity of institutions and experts. these initiatives can help solve serious problems and urgent needs that challenge china's exploration of foreign public health assistance in the new era and can help meet the requirements for the construction of public health systems in african countries. global health governance and bilateral health development cooperation continue to face many challenges such as the lack of talent, knowledge, experience, and language (chinese personnel, institutions, and health officials in embassies abroad lack capacity and experience in handling foreign aid). therefore, the treatment of foreign aid workers and overseas workers should be heavily monitored to ensure that their children's education and their family's health are promoted, which would encourage more businesses and talents to work and live in africa. both state-owned enterprises and private enterprises seek assistance from governments to build hospitals and schools overseas for chinese citizens in africa. only when key issues concerning education and healthcare are addressed properly will overseas workers be able to work steadfastly and more talent can be attracted to africa. public health cooperation and exchanges are centered on people-topeople ties. this includes foreign health assistance from the government and the multi-level and multi-form cooperation and exchanges that take place between the authorities and the people. both should be equally emphasized. comprehensive long-term cooperation and exchanges are part of a grand project for at least the next years. however, people-topeople cooperation and exchanges have more potential and are more comprehensive and sustainable, and should thus be provided sufficient support and attention. for example, after the establishment of diplomatic ties between china and america, there were cooperation and communication between official authorities of the two countries at all levels. however, cooperation and communication between people, institutions, schools, enterprises, and organizations have become broader and deeper. although the driving power comes from many sources, the main power has come from enterprises as institutions and organizations are able to benefit monetarily. finding a sustainable motive for people-to-people health cooperation and exchanges is an issue that must be addressed. these types of health cooperation and exchanges should be led by universities, research institutes, academic organizations, national and provincial hospitals, centers for disease control and prevention, and local medical and healthcare organizations. they must include multi-level, multi-form actions that include hosting academic meetings and visits, developing exchange programs for scholars, undergraduates, and postgraduates, establishing scholarship, conducting joint research, and facilitating other kinds of research on communicable diseases. thus, policies and mechanisms to provide support and services for non-governmental health cooperation and exchanges are urgently needed, including overseas healthcare, accident aid, insurance, danger prevention, customs clearance of materials, tax exemption, and preferential treatment for investment in the medical and health industry. we must recognize the current global health situation and see it from the perspective of politics, diplomacy, and development to meet the challenges that lie ahead. china will, as always, follow its existing guidelines, work diligently, and promote development. work together to build a community of shared future for mankind from the millennium development goals (mdgs) to the sustainable development goals (sdgs): africa in the post- development agenda. a geographical perspective global health and the belt and road initiative the list of countries that have signed cooperation documents with china on co-construction of belt and road initiative ministry of commerce of the people's republic of china: china and africa help each other under the framework of south-south cooperation multidrug-resistant tuberculosis antimalarial drug resistance in africa: the calm before the storm? hiv drug resistance report china tourism academy. statistical of china's tourism countermeasure studies on development of border trade in transitional china china will donate million to the global avian influenza prevention and control information office of the state council of the people's republic of china. medical and health services in china leaders from china and africa come together to build stronger and healthier communities medical education: what about the barefoot doctors? under-five mortality rate: total maternal mortality ratios in chinese counties, - , and achievement of millennium development goal in china: a subnational analysis of the global burden of disease study did we reach the targets for tuberculosis control? regional and national incidence and death for hiv, tuberculosis and malaria during - : a systematic analysis for the global burden of disease study vaccination is essential-past, present and future the new face of china's foreign aid: where do we go from here? experiences and challenges in the health protection of medical teams in the chinese ebola treatment center we appreciate miss zihan si for her language editing support. we are also grateful to the two anonymous reviewers for their valuable comments in response to our submission. this study was funded by grants from the national natural science the authors declare that they have no competing interests. key: cord- -ele cz authors: johnson, claire d.; green, bart n.; konarski-hart, karen k.; hewitt, elise g.; napuli, jason g.; foshee, william k.; brown, jason w.; kopansky-giles, deborah; stuber, kent j.; lerede, caterina; charlton, scott t.; field, jonathan r.; botelho, marcelo b.; da silva, kendrah l.; tønner, gitte; yap, terrence bk.; gkolfinopoulos, vasileios s.; quintero, gabriel; agaoglu, mustafa h. title: response of practicing chiropractors during the early phase of the covid- pandemic: a descriptive report date: - - journal: j manipulative physiol ther doi: . /j.jmpt. . . sha: doc_id: cord_uid: ele cz objective: the coronavirus disease- (covid- ) pandemic has strained all levels of healthcare and it is not known how chiropractic practitioners have responded to this crisis. the purpose of this report is to describe responses by a sample of chiropractors during the early stages of the covid- pandemic. methods: we used a qualitative-constructivist design to understand chiropractic practice during the covid- pandemic, as described by the participants. a sample of chiropractic practitioners (doctors of chiropractic, chiropractors) from various international locations were invited to participate. each described the public health response to covid- in their location and the actions that they took in their chiropractic practices from april through may , . a summary report was created from their responses and common themes were identified. results: eighteen chiropractic practitioners representing locations and countries participated. a variety of practice environments were represented in this sample, including, solo practice, mobile practice, private hospital, us veterans administration health care, worksite health center, and group practice. they reported that they recognized and abided by changing governmental regulations. they observed their patients experience increased stress and mental health concerns resulting from the pandemic. they adopted innovative strategies, such as telehealth, to do outreach, communicate with, and provide care for patients. they abided by national and world health organization recommendations and they adopted creative strategies to maintain connectivity with patients through a people-centered, integrated, and collaborative approach. conclusion: although the chiropractors in this sample practiced in different cities and countries, their compliance with local regulations, concern for staff and patient safety, and people-centered responses were consistent. this sample covers all world federation of chiropractic regions (ie, african, asian, eastern mediterranean, european, latin american, north american, and pacific) and provides insights into measures taken by chiropractors during the early stages of the covid- pandemic. this information may assist the chiropractic profession as it prepares for different scenarios as new evidence about this disease evolves. coronavirus disease- (covid- ) , caused by severe acute respiratory syndrome coronavirus (sars-cov- ), was discovered in late . in january , details about the disease were still unknown making public health decisions challenging. by early march, the disease spread rapidly with the number of cases increasing by -fold and the world health organization (who) declaring a pandemic on march , . [ ] [ ] [ ] by april , there were . million confirmed cases and deaths and by may , there were . million cumulative confirmed cases and deaths due to covid- globally. [ ] [ ] [ ] who published its strategic response and preparedness plan that provided recommendations for both the public and health care providers. it was estimated that approximately % of covid- cases were severe or critical and that covid- had a globally estimated average fatality rate of %; however, rates varied by country. for example, on may , the observed case-fatality ratio for the united kingdom was %, while for the netherlands it was . %, brazil was . %, and the united states (us) was . %. the rapid spread of covid- has had tremendous impact but especially on healthcare resources and personnel around the world. , , during the early phase of the covid- pandemic, health care providers faced difficult situations screening for this high-threat pathogen while caring for those who were infected and trying to mitigate spread of the virus. measures to control the novel disease created additional burdens on the health and social care systems. medical providers and first responders faced difficult life and death decisions in the midst of a severe supply shortage at the same time that they were putting their own lives at risk. to protect the health of the community, all people around the world were asked to join together in solidarity to fight covid- using various measures. , , , , along with other health professionals, chiropractic practitioners (ie, doctors of chiropractic (dc), chiropractors) faced unknown territory as they navigated health care in the context of unprecedented governmental restrictions and public health responses. chiropractic is a recognized and licensed health care profession in many world regions. each country, state, or province has its own regulations for the chiropractic profession. however, depending on preceding historical and social factors, local regulations and scopes of practice vary. [ ] [ ] [ ] as of , the world federation of chiropractic (wfc) estimates that there are nearly chiropractors in the world. although the majority of chiropractors ( %) currently practice in the us, the number of chiropractors in other countries is growing. patients typically have direct access to chiropractors and do not require a referral to receive chiropractic care. chiropractors often function as primary contact practitioners (ie, in some areas this is known as portal of entry) and work at the primary level in healthcare. , , , chiropractors are part of the healthcare workforce and collaborate with other providers to deliver the safest and most effective care possible to their patients and the public. , one view of chiropractic is that it "is one of the healing professions dedicated to conservative and natural methods of health care and recognizes the body's innate ability to heal." chiropractic primarily focuses on physiological and biomechanical aspects of health, including spinal, musculoskeletal, and neurological components, but also includes consideration of psychological, social, and environmental relationships, which is congruent with the biopsychosocial model of care. [ ] [ ] [ ] [ ] it has been suggested that chiropractic care "offers potential for costÀeffective management of neuromusculoskeletal disorders." thus, chiropractors may contribute to reducing the global burden of back and neck pain. [ ] [ ] [ ] [ ] [ ] according to the who guidelines on basic training and safety in chiropractic, chiropractic "is one of the most popularly used forms of manual therapy." the chiropractic profession is known for high rates of patient satisfaction and a hands-on approach to care. , [ ] [ ] [ ] [ ] [ ] people seek out chiropractic care for a variety of reasons, but commonly for musculoskeletal concerns, such as back and neck pain. , , the median -month utilization of chiropractic services has been estimated to be . % globally. therefore, due to its common use, taking a closer look at this health profession in the context of response to the covid- pandemic is warranted. pandemics create challenging circumstances for all health care providers. regulations for physical distancing and other measures to control the spread of covid- has disrupted daily life and routine health care practices. clinical practice is especially challenging for those professionals who routinely use their hands as a part of their assessment and treatment for managing patients. currently, it is unknown how individual chiropractic practitioners have responded at the time of physical distancing and stay-at-home orders. therefore, the purpose of this qualitative report is to describe actions by an international sample of practicing chiropractors during the early stages of the covid- pandemic. this is a qualitative, narrative research study using chronological, story-oriented reporting. because qualitative research is focused on the perceptions and experiences of people, we used a qualitative-constructivist approach to understand chiropractic practice during the covid- pandemic as described by the participants. this approach strives to understand the complexities of experience from the point of view of the participant. inherent to the constructivist-qualitative approach, we made no attempt to control variables and accepted the complexity of the phenomenon as a whole. this descriptive report includes chiropractors' actions during the early covid- pandemic between the dates of april to may , . the primary author (cj) was responsible for the research design and analysis, and invited chiropractic practitioners from different international locations to participate in this report. as far as the first author was aware, none of the chiropractors reporting actions taken in their practices had regular communications with one another (except ks and cl who are married). the only connection among the practicing chiropractors was that they were known by the primary author. the invitee list was blinded so that no one knew who else was invited initially. it was presumed that practitioners in each location acted independently in their actions and responses to the pandemic. anyone who was invited but declined or did not respond was excluded from this report. the role of the researcher is an integrated part of qualitative research. therefore, the investigator's influence on the research setting is seen as a benefit and not a detriment to the process. thus, each author's interpretation of their experience during the pandemic is considered enriching to the methods. the constructivist approach typically utilizes broad and general questions to capture the richness of the participants' experiences and how each navigates the cultural and social influences on their lives. accordingly, each participant was asked to answer open-ended questions with a limitation of words: ( ) provide a description of the public health response to covid- in their local area and ( ) provide a brief synopsis of actions that they took in their chiropractic practices in response to covid- . the first author collected and collated the responses and drafted a summary report. all contributors reviewed the full manuscript for accuracy and approved the final contents. all communications were completed by email. each coauthor consented to participate and contributed as a co-author, as defined by the international council of medical journal editors criteria for authorship. for this report, we followed the standards for reporting qualitative research according to o'brien et al. this was not an experimental study. this was a retrospective, self-descriptive report. no private health information was included, and each participant consented and contributed as an author; thus, no ethics review was sought. eighteen chiropractors representing locations in countries participated. their location, number of chiropractors in their country, and number of confirmed cases of covid- are represented in figure . , , the following summaries from the individual chiropractic practitioners describe their locations and how each responded to the covid- crisis. on january , , the first case of covid- in california was reported. following this, the first known fatality in the us occurred in northern california on february . the governor of california declared a state of emergency and a statewide stay-at-home order on march when the number of confirmed covid- cases in california exceeded . businesses were closed unless they were considered to be part of the critical infrastructure, such as healthcare. however, the state's director of public health recommended that routine or elective health services be rescheduled to a later date. health care providers were encouraged to use telehealth, rather than inperson visits. some california counties issued requirements for all citizens to wear face coverings when they were in proximity to anyone other than family members. bart green. i provide chiropractic services and am integrated in an interprofessional, collaborative team at a worksite health center. services provided at this location include primary medical care, behavioral health, physical therapy, acupuncture, nutritional counseling, optometry, and chiropractic. we serve an ethnically diverse population with an international demographic. this patient population frequently travels domestically and internationally for business or family visits, particularly to southern and eastern asia. in the health center, i normally use standard infection control measures, such as wiping down treatment tables with antiseptic cleaners in between patient visits, hand washing before and after each patient encounter, and regular office hygiene and safety protocols, as recommended by the joint commission. in the first week of march, when the covid- outbreak was increasing in prevalence and spreading in distribution in california, infection control measures were enhanced to additionally include wiping down door handles, seat arm rests, and other frequently touched areas in between each patient visit. as recommended by who and the us centers for disease control and prevention, we began to practice physical distancing between patients and between staff members. , patients were asked screening questions before scheduling and when checking in for an appointment. only patient was allowed in the reception area at a time; others waited outside of the health center. in response to the state mandated stay-at-home order, other providers at the health center and i transitioned from in-office visits to telehealth encounters. patients scheduled for in-office appointments were called and invited to reschedule to telehealth visits at their discretion. since march , all chiropractic visits were performed using real time video conferencing, secure messaging, and other telehealth mechanisms deployed from my home office. telehealth patient visits were done using a secure video platform that was integrated within the electronic health record. both new patient consultations and follow-up visits were conducted. many of the exam procedures that were normally done in the health center were done through videoconferencing through verbal instruction or by having the patient mimic what i was doing. this approach was also used for home exercises. video visits allowed me to spend more time on patient education and my patients seemed to like this format. using the electronic health record program, after visit selfcare and home exercise instructions were sent via a secure messaging system. no patients presenting during this time had any severe health problems requiring referral. however, appropriate resources were in place in case referral was necessary. thus far, patients have provided positive feedback about the use of video visits. many expressed gratitude that they were able to receive care remotely and avoid community exposure to coronavirus. on march , , the first case of covid- was confirmed in arkansas. on march , the arkansas department of health and the arkansas state board of chiropractic examiners stated that individual chiropractic physicians were to determine whether their office remain open. this recommendation was subject to change at the discretion of the governor and secretary of health. the arkansas department of health recommended that patient care that could be safely postponed be rescheduled to a future date. the following criteria were recommended by the department of health to determine if a patient should be rescheduled: ( ) temperature of . ⁰ f or greater, cough, or other symptoms of covid- ; ( ) aged years or older; ( ) immunocompromised and/ or had chronic disease; or ( ) returned from international travel within the past days. strict adherence to universal precautions were recommended to minimize disease transmission. it was thought that by rescheduling patients, dcs could contribute to preventing community spread and preserving the limited supply of personal protective equipment (ppe) that was critical for frontline healthcare personnel responding to this pandemic. the arkansas department of health recommended that chiropractic offices consider several prevention measures. the first was to remove items such as magazines and children's toys from patient waiting areas. it also advised that a single sign-in sheet per patient be used or to sanitize digital sign-in screens and styluses after each patient used them. sanitizing exam tables and rooms after each patient encounter was recommended. patients and staff were asked to practice social distancing in the waiting room, patients were encouraged to wait in their cars until called in for appointments, or that an alternative waiting room procedure be offered to patients. employers were to inform sick employees to stay home and employees who became ill were to be sent home. respiratory etiquette and hand hygiene were advised for all employees. the department also recommended that clinic staff perform routine environmental cleaning. karen konarski-hart. my chiropractic practice is a home office in little rock, the capitol city of arkansas, located within miles of several local hospitals. many of my patients are employed in the local healthcare system and also are caretakers of family members. during the early period of the pandemic, we did not have a shelter-in-place order. during the first weeks of the outbreak, many people with possible covid symptoms presented at healthcare facilities. as these numbers grew, hospitals became shortstaffed and staff were working long shifts. health and government officials discouraged the use of emergency or urgent care facilities except for medical necessity. during that time, many patients who presented to my office with acute musculoskeletal concerns did not want to go to a medical facility for fear of covid- exposure. i saw an increase in patients who were caregivers for their families. they often had symptoms of mental stress because of the additional duties of protecting and caring for their loved ones during the pandemic. signs and symptoms of stress included new onset of muscle spasms, headaches, or temporomandibular joint issues. for some patients, their desire for social contact, conversation and reassurance seemed as great as the need for treatment for their musculoskeletal symptoms. patients who were sheltering in place and no longer had social contact from their churches or social groups commented on how happy they were to see and talk face-to-face with another person during their treatment visits. my practice normally offers random urine drug sampling for professionals who are in a program to maintain their license. many healthcare workers in these programs frequently test at their worksite's emergency department. however, because of the fear of covid- exposure, i saw an increase in these clients. thus, my clinic was helping as an alternate location for these services. my clinic followed the arkansas public health recommendations. we asked patients covid screening questions when they called for an appointment. if they were suspected of having a covid infection, they were referred to the medical center for screening and testing. patients were expected to enter the clinic alone unless they needed assistance. i met them wearing a gown and mask, walked them directly to the treatment room and walked them directly out after treatment. any forms were filled out by me in the treatment room so there was minimal sharing of pens or clipboards. we kept patient appointments scheduled apart from each another to avoid contact between patients. if someone arrived early, they were asked to wait in their car or on the open porch. the treatment room had all smooth surfaces, and chair and treatment table arm rests were wrapped with disposable plastic film, which made wipe downs and spraying easier between appointments. paper napkins were inserted in the facepiece crease and patients were gowned. i washed my hands before and after treatment and used sanitizing gel within the patients' view. i also sprayed and wiped the table so the patients witnessed that the surfaces were clean. the governor of oregon increased restrictions as a response to covid- starting on march , . restrictions included closing schools for weeks and limiting gatherings to less than people. on march , school closures were extended for more weeks, gatherings were limited to less than people, and all restaurants and bars were closed. on march , a mandatory shelterin-place order banned all non-essential travel. health care was considered an essential service and dcs were included as essential healthcare providers. on march , the governor prohibited any non-essential (ie, non-life-threatening) healthcare procedures that required the use of ppe, to conserve ppe for critical care. elise g. hewitt. my chiropractic practice includes dcs (ie, general chiropractic practitioners and chiropractic pediatric specialists.) the clinic has an office manager and receptionists. to address the community's concerns about the covid- pandemic, my staff and i communicated with patients about the extra safety measures we are took to protect their health. these procedures were posted on the office web page, office facebook (menlo park, ca) page, and emailed to each patient. since much remained to be discovered about covid- , i continued to monitor the latest developments and modified procedures as new information warranted. my goal was to provide chiropractic care that contributed to patients' well-being in an office that had low risk for infection. to this end, a hospital-grade air purification system was installed on the office hvac units. this system uses an ozone and hydroperoxides oxidation technology to eradicate . % of all airborne and surface pathogens capable of eradicating the droplets of a sneeze at a feet distance. we instituted additional protocols to further limit exposure. patients were screened to identify if they were ill or were exposed to anyone ill when they scheduled an appointment and were screened again when they arrived at the office. we limited those entering the office to only those who would be treated. for pediatric patients, we asked that only parent or caregiver attend the visit and that siblings who were not being treated be left home. once patients arrived, they were asked to remain in their cars until their treatment room was cleaned and ready, at which time they received a call from the receptionist, who opened the front door for them. upon entering, patients were asked to clean their hands with hand sanitizer located on the front counter or with soap and water in the reception area bathroom. after this, they were escorted to their treatment room. the receptionists controlled the flow of patients so that only patient was in the reception area at a time. in the treatment room, i wore a mask and took the patient's temperature before commencing with the history. any patient with a fever was asked to go home and re-schedule once they were well. patients were provided with covid- information if needed. upon leaving the treatment room, if no one else was in the reception area, patients re-scheduled at the front desk. we instituted a modified method for payment in which the patient inserted and removed their own card into and from the card reader, and the receptionist completed the payment transaction. alternatively, patients had the choice of returning immediately to their cars and then calling from their car to re-schedule, receive charges, and provide credit card information over the phone. once the treatment was complete, surfaces touched by the patient were disinfected, such as treatment tables and door handles. at the beginning and end of every day, and hourly during the day, bathrooms and other common areas were disinfected. while these measures were necessary, they were cumbersome. as a result, we increased the length of each treatment visit to accommodate the extra time required and to keep patient overlap inside the office to a minimum. my patients expressed gratitude for creating a safe environment in the clinic. "we are so grateful that you are open." "i am so grateful that i can come!" "thank you so much for being here!" i feel it is my responsibility as a health care provider to continue to provide the care my patients consider essential to their health. i and the others in my clinic strive to do this in an environment that protects the health of our patients, our staff, and the community in which we all live. the missouri governor issued a stay-at-home order on april , that remained in effect until may with the county of st louis extending the deadline for an indefinite period of time. in the state of missouri, dcs are considered essential healthcare workers as outlined in the us department of homeland security memorandum on identification of essential critical infrastructure. additionally, the missouri chiropractic physicians association made a statement to encourage dcs to make an educated decision about what is best for their patients, their practice, and their loved ones with their decision to continue seeing patients. jason napuli. i am a chiropractor within the veterans administration (va) st. louis health care system. this location serves us veterans throughout the eastern missouri and western illinois regions. chiropractic service is aligned with the va's whole health initiative locally and within rehabilitation and prosthetic services nationally. chiropractic providers work closely with the veteran's primary medical provider and complimentary and integrated health teams in an effort to improve quality of life, function, and self-management strategies. starting on april , , all health care at this location focused on emergent and urgent care. many of the providers either shifted to inpatient care or screening stations while at the same time providing telehealth for their other patients. to reduce the risk of exposure to patients, my inperson visits were converted to telehealth visits. the interface i used was va video connect, which is a va technology that connects va providers with veterans using live video in a secure appointment virtual room. for those veterans who were unable to connect via va video connect, we called them by telephone. during chiropractic telehealth visits, i took health histories, completed a limited examination, and provided patients with appropriate education, exercise, ergonomic recommendations, lifestyle instruction, and reassurance/ compassion. patient recommendations included simple movement activities, directionally preferred exercises, selfmobilizations, nutritional guidance, and overall lifestyle changes to help them self-manage their conditions. during these visits, i was able to link veterans to a variety of whole health virtual offerings, which included information to maintain healthy living with complimentary and integrated health self-management strategies including mindfulness, meditation, nutrition, coaching and peer support, and videos on yoga, tai chi, acupressure, postural advice, and nutritional support. veterans indicated a high level of satisfaction with these modalities and self-management strategies. i encountered some challenges with technology including user ability, bandwidth, and dropped calls. however, veterans expressed their appreciation for the telehealth care that i was able to provide during the pandemic. on march , , a public health disaster due to covid- was declared in dallas county. on march , dallas county, texas judge clay jenkins issued more restrictive requirements with earlier interventions than at the state level jurisdiction to mitigate transmission. the texas governor issued an executive order closing schools, limiting statewide gatherings to less than people, limiting food and beverage operations to carry-out/delivery, and closure of nonessential businesses. dallas county was put under shelterin-place orders until april , where dallas county residents were advised that tiered openings of businesses would occur incrementally, dependent on county capacity for testing and tracing of positive cases. health care operations, which included chiropractic practices, were deemed as essential businesses, where employees and patients were required to wear masks to cover the mouth and nose. homemade coverings, bandanas, and scarves were permissible. the texas board of chiropractic examiners confirmed chiropractic care as an essential service. the texas board of chiropractic examiners issued guidelines on appropriateness of chiropractic care through april that stated, "licensees should only provide essential chiropractic services for patients with current or recurrent complaints of pain or disability which adversely affects the patient's ability to engage in the essential activities of daily living or work, or adversely affects the patient's quality of life, and with anticipation of material improvement under chiropractic care." as of may , updated orders included that licensed chiropractors could provide wellness care but, "should continue to adhere to safety and prevention best practices specified in the most current advice from the centers for disease control." william foshee. my chiropractic practice is in dallas, texas, which is a city of . million people. i am an employee in a group practice with up to chiropractors working on any given day before the pandemic began. my patients often begin care with a musculoskeletal complaint and transition to wellness care depending on patient preferences. many of my patients are ethnic minority. i regularly treat patients who primarily speak spanish. i also serve a large portion of the sexual minority population, which is represented by those whose sexual identity, orientation or practices differ from the majority, such as lesbian, gay, bisexual, or transgender. sexual minorities may have different risk factors and experience poorer health outcomes and therefore may be at greater risk. i also have a small, solo practice where my patients are almost exclusively sexual minorities. i limit patients in my solo practice to active care. during the early response to covid- , clinic intake procedures included screening patients for fever, symptomatology, and travel history. assessment and treatment were limited to individuals who denied international or out-ofstate travel in the previous weeks, infection or known contact with a person experiencing covid- , and history of fever, cough, shortness of breath, dysgeusia, or hyposmia in the previous weeks. all of this information was noted in patient records. prospective and existing patients were delayed care for -weeks or until their responses were compatible with the screening requirements. i disinfected the treatment table between patients and sanitized frequently touched surfaces. i asked patients to wait in their cars until the time of treatment. alcohol-based hand sanitizer and tissues were available in all spaces accessible to patients. there were no other items for patients to touch, as pens were sanitized between patients and all other material, magazines, and water cooler were removed. spinal manipulation was limited to prone and instrument assisted techniques to better control the direction and velocity of forced expiratory projection. new and existing patients presented with musculoskeletal complaints such as radiculopathy, tension pattern headache, posture induced musculoskeletal pain from working at home, injuries related to home improvement projects, and exacerbations of chronic or ongoing complaints. i noticed that patients seemed to be more sensitive and had a lower pain tolerance, possibly due to the additional mental stress because of the pandemic. new york (ny) state was an epicenter of the us covid- pandemic. executive orders in ny state limited business activity to essential business, later clarified to include emergency chiropractic services. this guidance allowed chiropractic practices to remain open. the impact of covid- varied widely throughout the state. many chiropractors in ny voluntarily closed their practices out of service to public health, patient protection, or due to risks to providers/staff. for those practices that remained open, emergency chiropractic services included management of urgent and necessary neuromusculoskeletal conditions to avoid overwhelming emergency care settings. services provided to essential front-line workers allowed them to continue necessary functions. when face to face care was not possible, an executive order allowed ny chiropractors to provide telemedicine services so that patients could access clinical advice in self-care, home exercise, ergonomics, nutrition, and stress management. , new york agencies advised that by april ppe was required to be provided to all workers in essential businesses that had contact with the public. this included office staff with patient contact and clinical providers. beginning on april , the general public was required to wear protective masks whenever they were in public and could not social distance; attending an office visit fit this description. jason brown. my practice is in a suburban setting near albany, ny. the practice has chiropractors and staff members. we modified the schedule so that only practitioner and staff member were working at any given time to lessen exposure and maximize space and distancing in the office. during that time, patients who received wellness and supportive care were advised to delay care until the crisis passed. for some patients needing supportive care and who would have severe progression of symptoms, care was delivered judiciously. the practice operated at a small fraction of normal volume, with most care provided to essential front-line workers, such as those in healthcare, first responders, and other essential business functions. acute and urgent musculoskeletal conditions were triaged and managed with an emphasis on self-care so patients could recover while maximizing their ability to remain at home. patients were scheduled with extra time between visits to minimize patient-to-patient contact in the reception area. increased time between visits also provided opportunity for a thorough disinfecting of all treatment surfaces and equipment and periodic disinfecting of commonly contacted surfaces such as countertops and doorknobs. steps were taken to reduce or eliminate exchanges between patients and staff. i noticed an increase in repetitive strain injuries. workfrom-home orders for non-essential workers throughout ny state led many people to use makeshift home office arrangements. an often less than ideal ergonomic environment seemed to contribute to increased reporting of postural and repetitive strain injuries. therefore, i found that advice for home office ergonomics was helpful for patients. further, social isolation as well as fear and anxiety around both the infectious and financial aspects of covid- heightened patients' needs for psychosocial interventions. to address patient concerns, we worked to establish procedures for managing disease symptoms or exposures. we gathered state and national resources to provide patients with accurate and actionable information. we provided access to home resources including yoga and meditation apps or internet sites, home exercise options, and financial resources. on april , , canada implemented the covid- emergency response act, enabling government to make sweeping changes for the protection of the public. in march, ontario implemented an emergency order shutting down all non-essential workplaces as required by the directive from the chief medical officer of health. chiropractors were required to close their offices, except for limited weekly hours for treating only patients with urgent musculoskeletal needs. the federal government implemented economic measures (ie, wage and business subsidies) to enable businesses and employers, including chiropractors, to apply for specified monthly income benefits to help offset business costs and also to cover % of employee wages during the period of 'pause' to minimize layoffs and lost jobs. on march , closures of public places followed. self-isolation, social distancing, frequent hand-washing, working from home, the use of cloth masks when shopping for groceries were implemented. the chiropractic regulatory authorities enabled chiropractors to provide telehealth visits, outlining standards for virtual practice. professional liability insurance was assured for virtual chiropractic visits. the canadian chiropractic association created an evidence-based telehealth best practice guide, for chiropractors. deborah kopansky-giles. i coordinate chiropractic practices at st. michael's hospital in the family medicine program. during that time, most ambulatory in-person health services were cancelled, except for essential medical visits. all chiropractic patients were notified by phone that in-person visits were not allowed. however, care continued through telehealth visits provided on a ministry of health supported platform enabling both audio and visual interactivity, depending on the patient's available technology. through virtual visits, patients reported their concerns, progress, demonstrated prescribed exercises and ranges of motion, performed functional tests, and received instructions for exercises. chiropractic care included providing reassurance, advice (such as pacing strategies, pain coping techniques), and covid- prevention education. collaboration with patients' medical physicians, pharmacists, or other health team members was facilitated through the electronic medical record or by phone. new patients with urgent musculoskeletal complaints were screened by telephone and provided with advice and education as indicated. if these patients requested an in-person visit, they were referred to a local, collaborating chiropractor who provided this care. we monitored patients who used telehealth to better understand the musculoskeletal conditions that may have resulted from isolation due to covid- . this practice serves the inner city of toronto, reaching the poorest and most vulnerable populations in ontario. at my location, chiropractors participated in wellness check-ins, which is a department-wide initiative. we identified individuals who were vulnerable or high risk for severe covid- impact and contacted them by phone to see how they were doing and to linked them with people and resources. over of the patients in our clinic database met the criteria for this initiative. by keeping people informed and feeling connected to their health team, particularly for seniors and low-income quintile patients, we hoped to minimize the impact of the covid- pandemic on their physical and mental health. alberta canada's first case of covid- was reported on march , . on march , a public health state of emergency was declared for the province. alberta's public health response included restricting mass gatherings to fewer than people, restricting visitation to health and senior care facilities, canceling international travel, and closing schools and non-essential businesses, facilities, and services. citizens were strongly encouraged by the government to stay at home, abide by social distancing rules, do frequent handwashing, and wear masks in public spaces. effective march , the alberta college and association of chiropractors (acac) suspended mobile visits (ie, any visit that does not take place in a clinical environment) and strongly recommended that chiropractors only engage in urgent care. the acac council approved a temporary permission for chiropractors to engage in telehealth with authorization from the registrar. on march , the chief medical officer of health of the government of alberta ordered the closure of close contact businesses, including chiropractic services, with the exception of urgent, critical, and emergency care. kent stuber. my practice is a mobile practice, which means i do not practice in a traditional clinic. instead, i provide chiropractic care at the patient's location. after mobile visits were suspended, i communicated with my patients and updated them on practice status by telephone, text messaging, videoconference, or e-mail. i informed them to contact me if they had any questions. i encouraged them to follow the advice of provincial and national public health officials. i advised patients to continue their active care plans for their musculoskeletal conditions, to be active on a daily basis, and to engage in mental health self-care, such as relaxation or meditation exercises. i obtained permission from the registrar to engage in telehealth visits. i maintained contact with patients to provide ongoing encouragement and follow-up. patients who required urgent care were referred to local chiropractors for in-person care. patients with stress, depression, anxiety, or grief were referred to mental health services for counselling. caterina lerede. my chiropractic practice is in a multiprofessional clinic, which includes other providers who are in the fields of physical therapy, massage therapy, and naturopathic medicine. i obtained permission from the registrar to engage in telehealth visits. beginning march , nonurgent chiropractic visits were cancelled. communications occurred primarily by telephone, text messaging, and email. i saw patients with pain and disability who were unable to self-manage any longer. patients who met the criteria for an urgent, critical, or emergency visit were scheduled for an in-person visit. if they did not meet the criteria, i provided home care options. if patients met the criteria, they were screened for signs or symptoms of covid- or for any risks of possible exposure. patients who passed screening criteria were booked for an appointment; any who did not were referred to public health services for evaluation. i contacted patients to provide advice and encouragement. steps to reduce exposure risk to patients and staff included disinfection of all examination and treatment surfaces and instruments between all patients, and social distancing. for example, we reduced the number of chairs and increased the distance between them in the waiting room. we staggered appointments to minimize risk of patient exposure in passing and installed a plexiglass shield at the front desk between the receptionist and the patients. during that time, the australian federal and state governments enacted restrictions including closing of international and state borders, closing of "non-essential" businesses, restrictions on gatherings, strict physical distancing, and orders to stay at home. for australian citizens, social contact was limited to visiting a romantic partner, supporting a family member, providing compassionate care and visiting a terminally ill friend. exceptions to the stay-at-home rules included shopping for essentials, work or education, medical (including allied health) appointments and exercise. inconsistency in state and federal rules meant we ceased all remedial massage therapy. scott charlton. my practice consists of myself, a massage therapist, and administrative and rehabilitation support staff. we are located on the edge of the city of ipswich, approximately miles from brisbane, the capital city of queensland. my practice is in between a small city and rural area, serving both those nearby and from surrounding rural communities. i restricted my practice to patients with acute pain and actively discouraged at-risk populations from attending. all patients were screened for whether they recently participated in overseas travel, had close contact with confirmed cases and if they had any flu like symptoms. all staff in the practice completed and were certified in the department of health online covid- infection control training. large signs were posted before and at the entry to the practice outlining the clinic procedures. hand sanitizer was provided in various stations throughout the clinic. the lack of reliable supply of basic cleaning products led me to use a specialist dental sanitizer that was effective against covid- . we sanitized all surfaces in treatment rooms and all touch points in the clinic between each patient. appointments were modified to ensure strict physical distancing. physical distancing rules in businesses evolved at that time to limit the number of people within a premise or a meeting room to no more than per square meters. my office size permitted people at any given time, though we elected to allow a maximum of including staff. we removed most seating and provided measured compliant distances to reduce potential patient exposure. we removed all magazines and pamphlets as well as all toys, books, and furniture from the children's area. we posted government endorsed signage throughout the practice that reinforced public health messages. all patients and staff were temperature scanned, observed for signs of being unwell and asked screening questions by the chiropractor in addition to administrative staff on each visit. the advice from the australian government and who was that ppe was in limited supply and should be reserved for front-line workers either with symptoms or treating those with symptoms. , , , for this reason, we elected not to use face masks at all times. masks were available for patients to use or have me use if requested. i modified history taking to be at a minimum meter distance from the patient. examination and treatment procedures were modified to minimize droplet transmission wherever possible. in my practice, we serve a portion of a lower socioeconomic population including many older patients and those with mental health illness. for those at likely higher risk due to covid- (eg, elderly, immunocompromised), we actively provided outreach by calling and advising patients not to attend unless their need was particularly urgent. i provided patients with regular electronic communications including updates on government recommendations and the approaches being used to help keep the clinic safe. i offered phone and telehealth consultations to patients as a means of easing their anxiety and answering any concerns. in late january , sars-cov- first arrived in the united kingdom (uk) carried by returning travelers. at that time, the national health authorities produced advice on physical distancing and hygiene in a public health campaign. new laws were introduced (the health protection (coronavirus) regulations ) in march, which provided the government with powers to control movement of potentially infected individuals. in the second week of march, anyone with a new continuous cough or a fever was told to self-isolate for days and vulnerable groups (ie, aged over , or with certain medical conditions or other risk factors) were advised to self-isolate at home. the following week, the uk prime minister curtailed all non-essential travel and contact with others. elective hospital activity was stopped and schools were closed, other than where needed to look after children who were considered vulnerable or children of key workers. places where people might gather, such as non-food shops, pubs and cinemas, were shut down. work began at several large venues in key locations to convert them into temporary hospitals to provide an additional specialist beds. chiropractic clinics were considered exempt from closure. however, on march , the royal college of chiropractors, the british chiropractic association, and the mctimoney chiropractic association published advice stating that provision of clinic-based care was incompatible with government guidance on social distancing and safe practice, effectively closing the chiropractic profession to face-to-face care. [ ] [ ] [ ] jonathan field. i work as a chiropractic first contact practitioner in a state funded national health services primary care facility, and work in a chiropractic research council funded university fellowship role for days a week. in the second week of march, all medical services within the practice moved to telephone or video consultations for vulnerable groups, with this extending to all but those with critical health needs by the end of the month. on march , i was released from my research activity, which enabled me to take on additional clinical duties to help free up a medical doctor to work at the hospital. since the enacting of emergency information technology system protocols within the clinic we had remote access to patients' electronic health records. this meant whilst conducting a full schedule of telehealth consultations days a week, i was able to isolate with my family and, along with others in the population, leave home only for period of exercise a day and shopping trip a week. many members of the chiropractic profession in the uk responded to the health protection (coronavirus) regulations by exploring new ways to engage with and support their patients. some implemented virtual appointments, while others volunteered to help in other roles within the national response to the current crisis. i created a support group using slack (slack technologies, san francisco, ca, usa) to help chiropractors in the uk learn about how to set up practice for remote consultations, including the technology and differences in the way consultations are conducted including the care that can be provided and the way we communicate. as of april , , brazil had the second largest number of people infected with coronavirus in north and south america, second to the us. the first confirmed covid- case in brazil was on february , . the first covid- related death in brazil was on march . from that point on, some states and cities implemented lockdown measures. on march , a national state of emergency was declared by the brazilian national congress, and lockdown and social distancing measures were widely recommended and implemented, following ministry of health recommendations. initial lockdown recommendations were set to last for days but were extended with adherence, depending on location. healthcare providers were considered vital in this coping process and were not included in any lockdown measures. telehealth consultations were provisionally accepted and recommended as an important tool to assist patients. social distancing and transmission preventive measures were adopted by the brazilian authorities. the use of face masks was mandatory for any worker in direct contact with the public. some major cities extended this as mandatory for anyone outdoors. due the lack of surgical masks available, double layer cloth homemade individual masks were considered acceptable by the ministry of health. people were to wash their hands for seconds or use hand sanitizer ( % alcohol). people were not to share personal items (eg, towels, tableware, glasses). citizens were to implement social distancing of m between individuals in any public space and avoid going outdoors. places where people may crowd were closed (eg, shopping malls, gyms, stores, clubs, and restaurants that now only work in a delivery basis) essential services such as health, food industry, transportation, and others were allowed to remain open. marcelo botelho. my chiropractic practice is located inside a private hospital. on march , the first reported covid- related death in my state (bahia) was at this hospital. some chiropractors nationwide decided to close their clinics in the first - weeks after the state of emergency was declared. i continued to see patients who had ongoing treatment needs and who were in severe pain but avoided new patient admissions. i reestablished front office services approximately weeks after the state of emergency was declared. to increase the efficacy of transmission prevention, the following measures were implemented in my clinic: face mask use was mandatory for myself, all staff members and other health care providers in the hospital. all patients were asked to wear face masks. if the patient presented without a mask, the clinic provided a mask. patients were asked to use hand sanitizer when arriving and before leaving the clinic. patients were informed, by cell phone message, about relevant information regarding prevention and relevant updates. these messages included the need to inform the clinic of suspected symptoms prior of clinical attendance, and to reschedule their appointments for a later date if it was the case. i modified the treatment schedule to have patient appointments at doublespaced intervals to avoid contact between patients. in between patient visits, my staff and i carefully cleaned the treatment tables with % alcohol, and also chairs, desk and any other surfaces the patient may have contacted. full clinic cleaning with antiseptic material was done every hours. on march , , the south african (sa) leadership declared a state of disaster due to covid- . after this, citizens were placed on a lockdown beginning march . the regulations governing the state of disaster dictated only essential services could continue, including emergency medical treatment. during that time, sa had comparatively few cases, few deaths, and large numbers of people who recovered from covid- . the minister of health, dr zweli mkhize, reported daily to the nation, warning that the worst was yet to come, and complacency would not be tolerated. because of the reduced demand on the health care system, sa was able to secure ppe, ventilators, and test kits. the national department of health had set up community test centers and secured vehicles for mobile screening particularly in high risk areas such as townships. the national institute for communicable diseases (nicd) monitored the covid- pandemic in sa. although there were some areas that did not have enough ppe or sufficient testing facilities, this was minimal. dedicated wards in hospitals were allocated. the homeless were sheltered, and the food package scheme gained momentum. the gap that needed attention was relief funding. chiropractors in sa were only allowed to register as sole proprietors, but the relief funding for such sole proprietors was extremely limited. this was concerning, as many chiropractors were challenged to sustain a lockdown for an extended period of time. there were relief funds for registered businesses, however, with little to no relief funding for practitioners, there was a concern that many would not be able to practice once the lockdown was lifted. registered businesses only had the option of loans, but no chiropractor was able to register as a business. all registered health care providers, including chiropractors, were permitted to consult emergency patients. those essential to the covid− pandemic (ie, the front-line staff for screening, testing, and treating) were permitted to be at work. chiropractors were permitted to consult in person only for patients with emergencies (eg, the patient may lose life or limb, or seriously deteriorate, if they did not receive intervention). to see patients, all health care providers required a permit as issued by their regulatory authority. the regulations for the allied health professions council of south africa and the health professions council of south africa registered professions was amended to allow telemedicine. malpractice insurance and medical aid administrators were mobilized to bring policy in line with the amended regulations. the chiropractic association of south africa (casa) issued an advisory to its members to adhere to the regulations and to close their practices. chiropractors were informed that they were allowed only to consult with patients with emergency conditions and to adhere to strict ppe protocol. the casa initiated a series of webinars, to educate chiropractors on the topics of covid- as well as telehealth, and a presentation on the increase and change in hygiene protocol which needs to be followed. these courses allowed practitioners to gain continuing education credits at that time. kendrah l da silva. i served on the advisory team for the medical response to the covid− pandemic in sa. my practice is located in an urban area. i have a solo practice and do not employ any staff, other than cleaning staff. since the state of disaster began, i kept my practice open for telehealth consults. i use the medici platform (medici technologies, llc, austin, tx, usa) to participate in telehealth consultations with my patients. most patients expressed that they wished to wait for the face-to-face consult once the lockdown orders have been removed. patients who participated in telehealth visits responded positively about the encounter and many experienced a reduction in their chief complaint, such as pain. before the lockdown was implemented, when i was seeing patients with face-to-face visits, i put out hand sanitizer for the patients. i have always sanitized before each patient, and handwashing after each patient. therefore, these practices continued. i wore a surgical mask and a coat, which was washed at the end of each day. most patients at that time wore their own masks. all touch surfaces were sanitized between patients. patients were booked with sanitization gaps in between. i informed my patients through electronic communications. information sent to patients originated from the south african covid− response, the wfc, and casa. for patients needing more personal attention, i helped by telephone or by video teleconsultations. starting march , , on orders of the dutch government, schools, day care centers and restaurants closed, and working from home was encouraged. a week later, government leaders announced a partial lockdown to allow hospitals to cope with increasing presentations of patients with covid- and to allow a level of herd immunity to develop. essential shops were allowed to remain open, however everything else was closed. citizens were not allowed to gather in a group of more than in a public space and had to keep . meter distance apart from others at all times. all cultural and sporting events in the netherlands were cancelled until september . in the netherlands, chiropractic is an unregulated profession. however, patients do not need a referral to see a chiropractor. on march , the netherlands national institute for public health and the environment (ie, known as rijksinstituut voor volksgezondheid en milieu (rivm)) increased public protection and limited health care provision for hands-on and para-medical professions. thus, only telehealth visits were allowed. , on april , the netherlands chiropractors association (nca) aided clarification that chiropractors were allowed to treat severe cases using ppe measures. thus, chiropractic care was opened back up, "in exceptional cases if the patient has a medical indication for this, the care cannot be given remotely or cannot be postponed and the practitioner during the treatment can comply with all advice from rivm regarding personal protective equipment." on april , the rivm changed the regulations again, resulting in chiropractors and other alternative care providers to be limited to only telehealth visits through may . gitte tønner. i practice chiropractic in a small solo practice in amsterdam. my patients have predominantly chronic and complex concerns with a variety of co-morbidities. following the governmental regulations, i saw patients with severe symptoms from march to , which was followed by not seeing patients between march and april . between april and , i saw patients again. i was very selective to which patients i saw since the risk of patients contracting the covid- could potentially increase when patients were traveling to and from the appointment. to answer their questions and concerns, i offered email consultations for my patients. when i was seeing patients, as per the nca hygiene standards, i wore an n mask, gloves, and a shirt exclusively for seeing patients. patients were asked to wash their hands thoroughly when they entered my clinic. my chiropractic table was outfitted with disposable layers for each patient. after each session, all disposables were thrown out. the chiropractic table and surfaces that were touched were cleaned. to avoid touch transactions, payment and receipts occurred electronically. after the visit, i cleaned the door handles as patients exited. i indicated in the patient clinical record the level of urgency of the patient's concern and the hygiene measures provided. three days after the treatment i emailed the patients to ascertain how they responded to chiropractic care and if they developed any symptoms of covid- . on january , , the first case of the covid- infection infiltrated the shores of singapore. prior to that, the government was already keeping a close eye on the spread of disease at ground zero, wuhan, china as the number of chinese travelers for leisure and business to singapore, hit . million visits in . hence, it was not a matter of if the disease would reach the shores of singapore, but a matter of when. on april , , the government implemented restraints to contain the spread of the disease. jobs that the government deemed as non-essential were required to cease and people to work from home. the chiropractic profession was initially regarded as an essential occupation but was later removed for unknown reasons. then, it was reinstated but then removed again. the chiropractic association (singapore) penned an email to the ministry of health (singapore) to appeal for reinstatement but this appeal was rejected. even though we were disappointed, chiropractors abided by the ministry of health's decision that they should remain closed at that time. terrance b.k. yap. my practice is in singapore, which is a multiracial and multicultural country. prior to closing my clinic on april , i took the proper hygiene measures such as social distancing, wearing a face mask, and temperature reading for all staff and patients. the air was regularly sanitized and clinic equipment disinfected after each patient. additionally, patients were required to answer and sign a travel declaration at every visit, enabling contact tracing if necessary. patients were to rest at home or seek medical attention if they had flu symptoms. these preventive measures were to safeguard patients and staff as well as to assure the public. on february , , covid- first appeared in greece. through early march, state authorities issued precautionary guidelines and recommendations were implemented locally to include the closure of schools and the suspension of cultural and sports events in the affected geographical regions. on march , with confirmed cases and no deaths yet in the country, the government suspended the operation of all educational institutions nationwide and on march all parades, cafes, bars, restaurants, museums, shopping centers, and sports facilities in the country were closed. on march , all retail shops were closed and all services for religious worship of any religion were suspended. following this, the government announced a series of financial support measuring billion euros to support the economy, including chiropractors. on march , restriction on all non-essential citizen movement throughout greece was imposed. since that date, movement outside the house is permitted only for reasons, including going to the pharmacy or visiting a health care practitioner. police identity or passport, as well as a signed attestation in which the purpose or category of movement is stated is required in order to move in public. the greek law enforcement authorities are empowered to enforce restrictions and can issue fines for each offense. these measures were considered among the most proactive and strict in europe and were reported by international press as the reason behind slowing the spread of the disease and having kept the number of deaths among the lowest in europe. , chiropractic practices had not been asked to shut down by the authorities. however, on march , due to the lack of chiropractic legislation, regulation, and malpractice insurance, the hellenic chiropractors' association recommended that its' members enact a complete shutdown of chiropractic practices in the name of public safety. in the absence of any recognition and or communication between the health care authorities and the chiropractic profession, it was prioritized to act responsibly and take no unnecessary risks in contributing to the spread of the disease. vasileios s gkolfinopoulos. my chiropractic practice is a general practice. my practice was one of the first in the country shut down on march . before closing and since march , my office was operating with strict precaution measures in place in the form of: spacing out of appointments; repetitive disinfection of all surfaces during the day; toilet disinfection after each use; hand sanitizer available in the reception area and treatment rooms; use of mask and gloves by practitioner; thorough disinfection of treatment benches before and after every treatment. patients were screened by telephone and if they exhibited any known symptoms of covid- they were advised to stay at home. following the government orders for shutdown, i provided services by phone. these included advice on selfcare, reassurance, psychological support, ergonomics, recommendations for diet/supplements, and rehabilitative exercises. on march , , the first covid- cases were reported in colombia. on march , the government declared a state of emergency. on march , mandatory confinement started and was extended until may . health workers initially were only allowed to work if they worked with concerns related to covid- patients. however, on april , general practices were allowed to open with strict bio-safety protocols. other restrictions were reduced to include other economic activities, such as construction, manufacture, and agriculture. adults could exercise outside while practicing social distancing during early morning. air and ground transportation were restricted only for passengers. gabriel quintero. my chiropractic practice is in the city of bucaramanga. i practice solo with chiropractic assistant, accountant, and the clinic manager. when the outbreak started, i followed increased safety procedures in my practice, which included increased hand washing, wearing a mask, and no hand shaking to welcome patients. the doors and windows were opened to let air circulate. on march , i closed my practice following government recommendations. since that time, i informed my patients via telehealth using whatsapp (menlo park, california) and e-mail to stay home following government orders. i provided patients with important information in response to covid- . i advised them about improving posture, maintaining lumbar support when sitting, especially for those who are working at home. i educated them about using an orthopedic pillow when in bed, proper hydration, good nutrition, decreasing refined sugar intake, and proper breathing methods. for those who had musculoskeletal complaints, i provided recommendations depending on their need, such as information about ice, exercise, and stretching. i emphasized the importance of mobility since sedentary life has negative consequences for the spine and general health. i have a general practice that normally sees about patients per day, days a week. once general practice was allowed to reopen, i followed strict sanitary protocols. my staff and i took the covid- test. if a test was positive and the person was asymptomatic, that person stayed home isolated in quarantine until the next covid- test was negative. if positive and symptomatic, the person would have been hospitalized for treatment. no more than patients were scheduled per hour in the clinic, each patient participated with disinfection and temperature measurement when entering the clinic. patients wore masks. my staff and i wore gloves, masks and disposable gowns. areas of contact by the patient, such as treatment tables and areas in the reception room, were disinfected after each patient. the first cases of covid- in the eastern mediterranean and middle east region was reported on february , in _ iran. the first case of covid- in turkey was detected on march . since then, the turkish authorities took systematic measures to control the spread of the coronavirus. the office of the deputy prime ministry and ministry of foreign affairs of the turkish republic of northern cyprus extended a partial curfew and travel ban to try to mitigate the spread of the disease. all people who were infected were sent to a designated hospital for testing, treatment, and observation under quarantine guidelines for days. there were restrictions in travel to and from provinces that were most affected. there was a partial curfew on leaving home during the weekdays and a complete curfew on weekends. all museums, archaeological sites and public gathering places, including cafes, parks, swimming pools, barber shops and sports centers were closed. restaurants were closed except for takeaway or delivery services. residents under the age of , and aged and above, were directed not to leave their homes. all individuals were to wear cloth face coverings in supermarkets and workplaces as well as in all forms of transportation including private vehicles with at least persons inside. local authorities could put in place additional covid- restrictions with little or no advanced notice. mustafa h. agaoglu. as a chiropractor and a law-abiding citizen, i support the decisions of the national authorities. my office was closed except for day of the week to support patients with noncomplicated, acute spine pain causing daily disability. one of my priorities was to care for health care providers working in local hospitals caring for patients with covid- . patient communication in my office was by telephone. i recommended home care, such as exercises. when caring for patients in person, the patients were required to have government issued n- face masks. patients were required to take off their shoes outside of the office. we provided surgical overshoes for patients. patients were required to thoroughly wash their hands before entering the chiropractic treatment space. payments for care were accepted through bank account wire. chiropractic tables were sanitized between each patient visit. patients were provided with standard government issued flyers with public health information for how to keep themselves and their family clean and sanitized. the hazards of smoking and positives of not smoking were shared extensively. patients were directed to the who and turkish health ministry updates for information and advised to stay away from social media news agencies on the matter to prevent the spread of misinformation. any patients who showed signs of anxiety or panic were given reassurance and empathy. as a policy of my clinic, i always have shown empathy to the urgent needs of my patients and the public. i aim to provide the best available service and unconditional caring is always a priority. those in economic hardship have always been dealt with humanely. as far as the authors are aware, this is the first published report that describes individual chiropractic practitioners' experiences and responses to the covid- pandemic. this study was based on a constructivist and naturalistic position and each practitioner was bound by their local regulations; therefore, some degree of variation was expected. the experiences represented here, as of may , ranged from the country with the greatest number of confirmed cases of covid- to other countries with fewer cases. this sample covers all wfc regions (ie, african, asian, eastern mediterranean, european, latin american, north american, and pacific) and provides insights into measures being taken by chiropractors around the world during the covid- pandemic. as demonstrated in this sample, chiropractors work in a variety of settings, each of which may have an influence on responses during a disaster or pandemic. environments in this report include solo practice, health care teams in hospitals, care in the va health system, a worksite health center, group practice, and a solo mobile practice. each work environment has its own unique requirements for day-to-day operations, but these may be especially different when facing a natural disaster or pandemic. for the chiropractors who practiced in solo practice, they assumed responsibility for the function of the office, including patient care, communications, and sanitation. solo practitioners may have had fewer resources but were able to respond quickly. in group private practice, chiropractors worked with each other and contributed to the practice. coordination among group practitioners regarding emerging clinic policies provided consistency of care. in other settings, chiropractors worked with other health professionals, such as medical providers, physical therapists, acupuncturists, massage therapists, or other health providers. in a worksite health center, the practitioners provided care for employees of a company and therefore the company's policies may have influenced processes, such as policies for hygiene or if employees were requested to work from home. hospital-based care (eg, private hospital, va hospital) provided chiropractors with access to resources, such as staff and supplies. however, hospitals had their own regulations in addition to local government regulations, such as for infection control and which providers on the workforce may continue care face-to-face. thus, those in more integrated practice settings or hospitals may have had more resources but needed to consider additional policies and mandates that resulted from the more complex infrastructure. themes were observed among these independent reports. a primary theme was that the practitioners focused on their primary duty, which is to serve others. they took great efforts to protect the health of their staff, patients, and the public. some transitioned from in-office visits to telehealth visits, when that was available, or shut down their practices if the government required this or if they felt that it was prudent. others continued to see patients in their clinic complying with public health regulations. for those continuing to practice, they established a safe working environment so that their services could continue. many modified their practices by increasing the use of available technology to reach patients who needed care. this included using telehealth, which provides health care remotely through telecommunications technology (eg, email, phone, and video conferencing.) and, many focused their care to serve front-line health care workers, who were responsible for taking care of patients who were acutely sick with covid- . another theme was responsiveness. each practitioner responded to unique timelines, government regulations, and regional restrictions as covid- increased in prevalence. chiropractors witnessed regulations that changed frequently, which sometimes resulted in contradicting instructions. despite these challenges, these chiropractors complied with local regulations and health boards and adhered to the recommendations of global and national bodies, such as who and the centers for disease control and prevention. they monitored changes in regulations and modified their practices to be compliant. another theme was the application of person-centered care, which is when a practitioner has respect for patients' preferences and values and provides them with information to help decide when to seek care and when to engage in self-care. the chiropractors communicated with their patients about the pandemic situation, including what care was available, how to access care, and other helpful health information about covid- . they viewed their patients' needs from their patients' points of view, such as reducing potential exposure within the clinic and in other environments, such as traveling to and from the clinic or while waiting for their appointments. their observations were congruent with the biopsychosocial model. in addition to the typical physical concerns that patients present to for chiropractic care, such as neck and back pain, the chiropractors observed that the pandemic likely resulted in their patients experiencing increased mental health concerns and physical signs and symptoms due to stress. the association of mental health and musculoskeletal pain and dysfunction is an important part of the biopsychosocial model of health care. these observations of mental health symptoms and the covid- pandemic are congruent with the observations of who. these chiropractors demonstrated collaborative behaviors. they worked with others within their local regulations. those in solo practice who did not offer in-person visits, referred patients to other practitioners. those in group practices or hospitals coordinated with and supported other providers. they demonstrated teamwork with other health care providers across disciplines and by doing so potentially helped to reduce redundancy of consultations and provide more effective and safer care. in summary, even though most of the participants were in different countries or types of practices, their responses were relatively consistent. they abided by national and who recommendations and they adopted innovative strategies to maintain connectivity with patients through a people-centered, integrated, and collaborative approach. they described that providing care was especially challenging when the evidence needed to make decisions and local regulations continued to change. they focused first on serving their patients, including front-line healthcare personnel, and continued to monitor the covid- situation and responded accordingly as new regulations and information became available. each practitioner's report was limited in length. thus, a detailed recount of each practitioner's operating procedures during the early phase of the covid- pandemic was not possible. this report is limited to the individuals who responded during a -week period in the early months of the covid- pandemic. the statements must be taken in a retrospective context and not applied to future practice. future behaviors will likely change as new information is learned, as government and local restrictions are modified, and as situations change. some settings included in this report may not necessarily be considered typical practice environments for other chiropractors. for example, we recognize that chiropractic practice in a private hospital may differ from an independent practitioner working in a solo practice. however, the aim was to provide breadth of view instead of demonstrating similar samples. the invitation list of providers was created by the primary author without the knowledge or input of the other coauthors thus, the participants reflects the bias of this author. there may be non-responder bias since those who did not reply were not included. due to space and time, not all locations or countries are represented. thus, it is not known what response practitioners from other countries may have had and how those responses may have influenced the themes noted. those represented here do not necessarily represent everyone in their region or the entire profession, however this information can provide some insight into how some chiropractors responded. the information provided here was the best available at the time of writing. regulations have likely changed since the time of capture of this information. although the chiropractors in this report practice in different cities and countries, their compliance with changing local regulations, concern for staff and patient safety, and peoplecentered responses were consistent. they did outreach and communicated with patients and they observed increased stress and mental health issues. they recognized and abided by changing governmental regulations and they adopted innovative strategies to communicate with and provide care for patients. this sample covers all wfc regions (i.e., african, asian, eastern mediterranean, european, latin american, north american, and pacific) and provides insights into measures being taken by chiropractors during the early stages of the covid- pandemic. this information may assist the chiropractic profession as it prepares for different scenarios as new information about this disease evolves. chiropractic practitioners in this sample demonstrated patient-centered behaviors to serve their patients, including front-line healthcare personnel they modified their practices to comply with unique timelines, government regulations, and regional restrictions. they reported increasing sanitation measures and modified patient interactions to reduce spread of the contagion. they monitored the covid- situation and responded accordingly as new regulations and information became available. they modified practice and patient encounters to include telehealth. epidemiological and clinical characteristics of cases of novel coronavirus pneumonia in wuhan, china: a descriptive study public health response to the initiation and spread of pandemic covid- in the united states coronavirus covid- has killed more people than sars and mers combined, despite lower case fatality rate world health organization. coronavirus disease (covid- ) pandemic an interactive web-based dashboard to track covid- in real time world health organization world health organization. covid- strategy update - world health organization. rational use of personal 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confirmed in brazil library of congress. brazil: ministry of health authorizes telemedicine during coronavirus pandemic how brazil can hold back covid- south africa's ramaphosa declares state of disaster over covid- south africa begins nationwide coronavirus lockdown. voa news covid- weekly epidemiology brief: week prime minister rutte addresses the country about covid- nederlandse chiropractoren associatie no king's day and premier league, hefty fines and strict enforcement chiropractic practices questions about the coronavirus and paramedical care singapore confirms first case of wuhan virus stb unveils targeted measures to support tourism businesses affected by -ncov singapore has banned all social gatherings greece confirms first coronavirus case accessed may , . . iefimerida. koronoios: cases in greece -parades are canceled greece to inject billion euros to support economy as coronavirus spreads greece bans flights from uk, turkey as coronavirus cases rise greece tops list of countries successfully flattening coronavirus curve in europe. the national herald web site ministry of health and social protection. colombia confirms its first case of covid- -colombia-quarantin/colombia-to-hold- -day-quaran tine-to-fight-coronavirus-iduskbn iran has far more coronavirus cases than it is letting on turkey announces its first case of coronavirus. the guardian the curfew has been extended until world health organization. mental health and psychosocial considerations during the covid- outbreak key: cord- -fk s v authors: babatunde, gbotemi bukola; van rensburg, andré janse; bhana, arvin; petersen, inge title: stakeholders' perceptions of child and adolescent mental health services in a south african district: a qualitative study date: - - journal: int j ment health syst doi: . /s - - - sha: doc_id: cord_uid: fk s v background: in order to develop a district child and adolescent mental health (camh) plan, it is vital to engage with a range of stakeholders involved in providing camh services, given the complexities associated with delivering such services. hence this study sought to explore multisectoral dynamics in providing camh care in one resource-constrained south african district as a case study, towards informing the development of a model for district mental health plan and generating lessons for mental health systems strengthening to support camh services using the health systems dynamics (hsd) framework. hsd provides a suitable structure for analysing interactions between different elements within the health system and other sectors. methods: purposive sampling of key informants was conducted to obtain an in-depth understanding of various stakeholders' experiences and perceptions of the available camh services in the district. the participants include stakeholders from the departments of health (doh), basic education (dbe), community-based/non-governmental organizations and caregivers of children receiving camh care. the data was categorized according to the elements of the hsd framework. results: the hsd framework helped in identifying the components of the health systems that are necessary for camh service delivery. at a district level, the shortage of human resources, un-coordinated camh management system, lack of intersectoral collaboration and the low priority given to the camh system negatively impacts on the service providers' experiences of providing camh services. services users' experiences of access to available camh services was negatively impacted by financial restrictions, low mental health literacy and stigmatization. nevertheless, the study participants perceived the available camh specialists to be competent and dedicated to delivering quality services but will benefit from systems strengthening initiatives that can expand the workforce and equip non-specialists with the required skills, resources and adequate coordination. conclusions: the need to develop the capacity of all the involved stakeholders in relation to camh services was imperative in the district. the need to create a mental health outreach team and equip teachers and caregivers with skills required to promote mental wellbeing, promptly identify camh conditions, refer appropriately and adhere to a management regimen was emphasized. page of babatunde et al. int j ment health syst ( ) : policy documents have helped to spur this [ ] [ ] [ ] , notably the world health organization's (who) policy framework for child and adolescent mental health policies and plans [ ] . however, the paucity of specific national camh policies and national implementation guidelines, poor intersectoral collaboration and the shortage of camh resources still hinder the provision of optimal child and adolescent mental health services in many countries [ ] . the burden of camh has been well-described, especially in lmics [ , ] . barriers to camh service provision in lmics will undoubtedly be aggravated by the covid- pandemic, an event that will substantially test the resilience and responsiveness of district health systems. it has already been noted that the pandemic will add to the current camh burden, and a strong system of governance, service provision and financing will be vital to ensure the well-being of children and adolescents [ ] . two considerations have especially been part of strategies to reform camh services, namely task-sharing and intersectoral working. while camh services have historically been framed to be the sole responsibility of specialists, some recent studies have revealed the possibility and significance of integrating camh services into primary health care (phc) through the tasksharing approach [ , , , ] . notably, the mental health gap project (mhgap) [ ] includes guidelines for the management of several camh conditions at phc level within a task-sharing approach. in terms of intersectoral working, camh has historically been under the stewardship of the health sector. an intersectoral approach that involves the collaboration of other sectors such as education, social development and juvenile justice is required to achieve an effective camh system of care [ , ] . while these considerations have been central to south africa's health policy landscape, the country lacks a wellarticulated camh strategy which is required to achieve a functional camh collaborative system at a district level [ , ] . in the development of such a strategy, there is a need to involve a wide variety of stakeholders across multiple sectors, including caregivers, teachers, community and spiritual leaders [ ] . haine-schlagel et al. [ ] , emphasized that engaging various stakeholders was critical to achieving an effective camh service delivery. these multiple stakeholders, particularly teachers and caregivers (parents, grandparents, foster parents and other family members), are perceived to be active gatekeepers to camh care, given their vital role in identifying and seeking help for children and adolescents with mental (behavioural, emotional, social and developmental) disorders. despite the inclusion of camh in core national documents like the policy guidelines on child and adolescent mental health [ ] and the national mental health policy framework and strategic plan - [ ] , within the ideals of integrated, collaborative care (including task-sharing and intersectoral working, little to no guidance exists for provincial and district governments to translate national guidelines into operational tools for district governance of camh services. considering this, the study aimed to explore multisectoral dynamics in providing camh care in one resource-constrained south african district as a case study, towards informing the development of a model for district mental health plan and generating lessons for mental health systems strengthening to support camh services. the study was guided by the health service delivery (hsd) framework which describes health service delivery as a process by which policies, services providers and infrastructures are organized to achieve the goal of the health system which is to provide easily accessible and quality healthcare services [ ] . the framework consists of ten elements, they include, ( ) goals and outcomes, ( ) values and principles, ( ) service delivery, ( ) the population, ( ) the context, ( ) leadership and governance, ( ) finances, ( ) human resources, ( ) infrastructure and supplies, ( ) knowledge and information. the premise of the hsd framework is that the health system is an open system which is often shaped and influenced by different societal factors. it describes health service delivery as a process by which policies, services providers and infrastructures are organized to achieve the goal of the health system which is to provide easily accessible and quality healthcare services. moreover, resources such as budget allocation, human resources, infrastructure and supplies, knowledge and information are fundamental to achieving a viable healthcare system for the populace. the population (service users) are described as major players within the health system. the authors emphasized that they are not mere patients but also citizens having rights to access quality healthcare. governance, as described by the hsd framework, entails policy guidance, coordination of the different stakeholders and activities at different levels of care and effective distribution of resources to ensure equity and accountability [ ] . an instrumental case study which is used to obtain an in-depth understanding of specific issues was conducted with the amajuba district municipality as the unit of analysis [ ] to explore the experiences of providing and accessing camh services in the district. employing a phenomenological qualitative approach using semi-structured interviews, the design allowed for the generation of in-depth information about lived experiences from multiple stakeholder perspectives [ ] . the study was conducted in the amajuba district municipality, in the north-west region of the kwazulu-natal province of south africa. the district which covers km with a population estimate of about , , is made up of sub-districts and comprises rural and periurban communities [ , ] . amajuba has been identified as a resource-constrained district as it has limited numbers of health professionals, including mental health specialists to provide adequate health care services for the populace [ ] . the bulk of the district's camh service capacity is situated in its three provincial hospitals. the district was a site for government piloting of the national health insurance programme-a government-driven initiative aimed to unify south africa's two-tiered health system by establishing a centralised funding mechanism in order to achieve universal health coverage [ ] . as part of its pilot site status, the district had limited school mental health services as part of the integrated school health programme, an extension of the revitalisation of phc, that includes teams of health care workers (hcws) visiting schools to conduct basic screening and referral services [ , ] . research participants were purposively identified according to their positions in the departments of health, social development and education. snowball selection was applied, leading to the identification and participation of key role players involved in providing mental health care to children and adolescents in the district. participants included managers and mental health professionals from the department of health, managers, educators and mental health support workers from the department of basic education, non-governmental service representatives, as well as caregivers of children and adolescents living with mental health challenges. a list of camh cases and conditions identified in the district over months have been published elsewhere [ ] . these conditions included autism spectrum disorder, attention-deficit/ hyperactivity disorder (adhd), different forms of intellectual disability, depression, schizophrenia, bipolar affective disorders, mood disorder, anxiety, conduct disorder, mental and behavioral disorders tied to substance abuse. a full list of participants and the characteristics of children whose caregivers were included in this study are presented in tables and . data gathering for this study took place from february to march . semi-structured interviews were used, allowing for the use of probes and follow-up questions to steer the discussion while allowing for the generation of in-depth subjective information [ , ] . the interview guide was informed by the findings of an initial review of literature on the barrier and facilitators of camh services in low-and -middle-income countries [ ] and the hsd framework. the interview guide covered a range of questions that explored the roles played by each stakeholder in relation to camh services, their perceptions, and experiences of child and adolescent mental health; experiences of accessing and providing camh services, and suggested pathways for systems improvement. all the stakeholders included in this study were either physically visited in their offices or contacted via e-mail, text messages, and telephonically to inform them and solicit their participation in the study. the majority of the stakeholders responded positively, and interview dates and time were secured. the operational manager at the madadeni hospital psychiatric out-patient department and the clinical psychologist at the newcastle hospital assisted with identifying caregivers and introduced them to the researchers. the caregivers were then informed about the study during clinic days and twenty caregivers consented to participate in the study. interviews were conducted in english and isizulu, depending on interviewee preference. the primary researcher (gbb), a doctoral student, conducted the english interviews while the isizulu interviewers were conducted by a trained research assistant with a bachelor's degree, who is proficient with the use of both isizulu and english language. the research assistant is also a resident of the community, and this facilitated easy rapport with the stakeholders. the interviews were audio-recorded, transcribed verbatim, translated, and back-translated where required. transcribed data were analysed using gale et al. 's [ ] framework method, a summary process for managing and analysing qualitative data, which produces a series of themed matrices [ ] . accordingly, six steps were followed: ( ) transcription, ( ) familiarisation, ( ) deductive organisation of codes based on the elements of the hsd framework, ( ) inductive coding of sub-themes under the hsd coding framework, ( ) reviewing data extract and charting ( ) mapping and interpretation of data [ , ] . using these interconnected steps enabled the researchers to sort, scrutinise, categorise and chart the themes and associated sub-themes that emerged from the data set [ , ] . the categories were reviewed to identify existing connections and differences between the themes from the different groups of stakeholders [ ] . the excel software package ( ) was used in creating framework matrices and coding the entire data set. the accuracy of transcripts was checked against original recordings, and the two researchers (gbb and av) who conducted the analysis compared results at regular time points to harmonise the content of themes derived from raw data. also, the classification was discussed iteratively between the researchers, with input from study supervisors (ab and ip). to further ensure trustworthiness, the data set was thoroughly read through to confirm that the data was meaningfully clustered under the the themes and subthemes of the findings are presented here in narrative form, according to the constructs of the health system dynamics framework, starting with service delivery. direct quotations are added to illustrate key points. themes under this component will describe the structure of the camh system in the amajuba district. this includes a general "overview of camh services", and "identification and referral". camh services in amajuba district municipality were diverse. public sector professional mental health services were provided in a largely centralised fashion by psychologists based at the district regional hospital. this hospital served as a referral point for at-risk learners identified within the school system. service providers who helped to identify and refer children and adolescents potentially requiring mental health care were situated at different levels of the community, health and education systems, and included nurses in clinics, social workers in the communities, educators, learner support agents and school health nurses in schools. beyond the public health system, there were also a variety of non-government service providers who provided mental health services such as awareness campaigns, assessment and referrals to a limited degree. this included general practitioners, religious counsellors, non-governmental/non-profit organizations (ngos/npos) and traditional healers. in terms of the content of camh services, health care involved psychotherapy and psychopharmacological support, largely provided in the hospitals. educators and caregivers mentioned additional interventions to assist children in the school environment and at home. extra classes were organized for learners identified to be dealing with psychological challenges and struggling academically. they expressed that these interventions were insufficient and were negotiating for professional psychological assistance for the learners from the department of education. further, the department of social development provided disability grants to children with intellectual disabilities and autism, illustrated by the following: "i was advised to register her for the disability grant from the government, so that helps cater for her needs. we are fine financially because she receives the grant." (caregiver ). a service that was described as especially problematic was early identification of camh problems and appropriate referral; with most camh conditions identified and referred by the school system-but were generally quite late in the illness progression, when they were affecting children's academic performances. very few cases were identified by health workers in hospitals, phc clinics, ward-based primary health care outreach teams (wbphcots), or by the caregivers. this finding was illustrated by the following: "in most cases what i found is that children are identified by their educators. they are identified there in school and then referred to the clinic and then from the clinics to us here. and, there are few cases where children are brought to the hospital for other things and mental health issues are picked up as a secondary problem that is seen, but otherwise in most cases it's the educators unless a child has a clear mental health issue that is visible then the child is brought into the health system by the caregiver." (clinical psychologist ). once a child has been identified as needing mental health care, further steps depend on the specific space where identification occurred, and the nature of the perceived need. the educators and learning support agents (lsa) in schools mentioned that they provided some initial assessment and interventions before referring the children for further care. however, four of the twelve schools visited within the district still did not have any skilled staff or resources to provide initial camh assessment or interventions to assist their learners, they also did not have any information on the referral pathways. integrated school health programme (ishp) teams were yet to adopt mental healthcare into their activity portfolio. "we identify learners who have special needs, behavioral problems or learners who are abused physically, emotionally and socially. firstly, we screen those learners, fill the necessary forms and then we sit down with the learners to find out what the problem is, identify how we can help and if we cannot help, we call in supervisors from the dbe district office, then they will come and assist. they either do one-on-one sessions or sometimes they will take a group for assessment. after assessing them, if they see that the learners do have problems, they refer those learners to special schools. if it's a behavioral problem, they make sure that they do follow-up interventions like counselling or social work consultation and they refer some of the learners to the psychologists." (lsa, school c). a principal mentioned the need to train educators to prevent inappropriate referral and labelling. "….to take this matter seriously we need some resources to assist the schools, then the training of teachers also is important. i don't want teachers to wrongly identify and say it behaviour problem when the learner does not want to write due the relationships you have with that learner-so training of teachers is very important-so that they can be able to identify the learner." (principal ). a senior mental health professional highlighted that the psychologists are mostly the first point of contact for children and adolescents with camh conditions within the hospital (most of the referrals from the schools are addressed to them) and they refer them to the appropriate specialists for cases in need of more specialized interventions. according to one of the psychologists: "when they come to us, they are mostly accompanied by their caregivers, if maybe they come from school they come with their educators. so, we do the debriefing to sort of understand the child's condition and give us a picture of what is going on so that we can determine which services they need, and then if they need to be referred to other specialists, we do that. (clinical psychologist ) . the psychologist also mentioned inappropriate referral from schools, children with learning disabilities that should be referred to educational psychologists are referred to the clinical psychologists. this is due to the shortage of educational psychologists in the district, thereby resulting in back referral. "children with learning difficulties are often referred to us but we always refer them back to the department of education because they have an educational psychologist. we understand that she is the only one for the district, and she's not coping. because of this, schools tend to push them towards the department of health, but we don't do those assessments". (clinical psychologist ). the availability and organization of camh resources in the district are presented below, according to human resources, infrastructure, and supplies, knowledge, and information. participants described a severe shortage of human resources to deal with camh problems within the departments of health and basic education. the service providers within doh mentioned that they are overwhelmed due to limited camh human resources, increasing camh workload and inadequate camh training for non-specialists. there was a widely-held view that camh services are limited in the district, but there was also sympathy from several participants that the few service providers were doing their best, and-under the circumstancespurportedly provided highly responsive care. caregivers were appreciative of the good communication and friendly engagement of key mental health professionals. this was illustrated by the quotation below: "we got a very great help, they really helped us, especially the provincial hospital… the services were very good, and they were very helpful. the medication he receives here is helping a lot. they communicate with me properly, i was even able to ask questions and they could answer, they have been very caring towards me and the child, so i can say it was very good. " (caregiver ). the lack of mental health human resources, and the resulting limitations in providing care, was bemoaned by one mental health participant as follows: unfortunately, we can't see them more than once a month like everyone else because of staff shortage. however, if there is an urgent need for treatment, like sometimes we do fear that these persons might do something to harm themselves then we try to squeeze them in, but we just see them once a month. we usually make appointments in the mornings for people to come and see us… however, for school going-children we do make provisions for them, we see them in the afternoons, we schedule their appointments for pm, so that at least they will be able to go to school in the morning. " (psychologist ). some medical professionals noted that camh services provided opportunities for self-development, as most of them are medically qualified professionals without formal qualifications in psychiatry or child and adolescent psychology. "i enjoy providing camh services …it's very interesting and challenging but i learn from the experience and it motivates me to develop my skills…i was working with a doctor who was about to retire so i joined her and she exposed me to one or two things before she left. i have some years of experience in it now, but i'm not a child and adolescent specialist, we don't have any in the district as well. " (medical officer ). the psychiatrist suggested that the camh system could be strengthened through the development of outreach teams to expand the camh workforce, ensure consistent in-service training across all the departments involved in delivering camh services, particularly for phc nurses to facilitate the integration of camh services into primary health care, conduct awareness campaigns and provide psychosocial support to families to strengthen the existing camh system. schools so that they can do in-service training and awareness campaigns… visit families because they need to capacitate them and support them. also, training, i have been yearning for this, the phc staff members should undergo camh training. " (psychiatrist). findings revealed that there were very few special schools catering for children with special needs in the district, and only two of them were equipped to admit children with camh conditions. an educator from one of the two schools stated that the school was overpopulated due to the increasing prevalence of camh in the district: "at first, we had the capacity of , but due to the increasing number of children with mental disabilities we have about leaners, our school is full. " (educator , special school ). there was widespread concern about the challenge of finding suitable schools for children whose mental health needs could not be met by their current schools. some children were not enrolled into school at all, because they were rejected by the mainstream schools, with the limited special schools available in the district being overwhelmed due to the lack of space and shortage of resources. a caregiver relates this as follows: "i once struggled to find a school for him and i am still having that challenge because i am yet to find one that can accept him. " (caregiver ). in cases where caregivers were successful in placing their children in special schools, they received additional support in the form of transport services, as described below: "he is now studying in a special school, where they have trained teachers who are knowledgeable about his condition, so i am happy he is in the right place. they taught him how to write when he got there…he's now trying to write his name. it is just okay because they also provide him with transport. " (caregiver ). the chief director of special schools from the district department of education explained the school placement procedure. "first, we do the placement assessment, when a leaner is referred for special school placement. a committee which consist of an occupational therapist, physiotherapist, the hod and the class teacher will sit to decide. we assess the physical ability of the child and then cognitive assessment all these assessments will assist us with class placement. you know, sometimes the learner comes to us at the age of and never accessed any form of education, but we can't place them in the first year of school. after series of assessments, once we realize the level of assistance needed by the learner, we then recommend placement, we will then ask the parents to sign a consent form where they would agree that the learner should be enrolled into a special school. " (chief director, special schools). a caregiver also voiced her concern about the lack of higher education or opportunities for career development for adolescents with mental disabilities. "my worry is that when they reach the age of they should not just stay home, there must be something for them to do because people take advantage of children in these kinds of conditions because a lot of them tend to wonder in the street after they leave school. maybe the government could help build a school that can take those that are over the age of . " (caregiver ). there seemed to be a lack of knowledge in communities on identifying mental health symptoms at an early stage. in some cases, caregivers noticed some symptoms at an earlier stage, but they couldn't specify the nature of condition and did not access care for the child until they were identified and referred from school. these caregivers also mentioned that they could not seek help for the children because they didn't have a clear understanding of the conditions, where and how to seek medical care. this is illustrated below: "i noticed before the school called me, but i couldn't take any step because i didn't know what the problem was and where to take him for treatment until he was referred by the school, they gave me a letter and i took her to the hospital. " (caregiver ) . some caregivers reported that they noticed certain symptoms of abnormality. although they couldn't ascertain the nature of the problem, they immediately sought help for the child. two of the caregivers took their children to the clinics close to them and were referred to the hospital while others took their children directly to the hospital. however, the caregivers who took their children directly to the hospital mentioned that they were requested to obtain referral letters from the school or a clinic. the following excerpt refers: "we noticed the problem at home, but we couldn't identify it as autism, so i brought him here to the hospital but then they said i should get a letter from his school about his condition. " (caregiver ). the results under this component reveal the characteristics of the camh service users mainly caregivers of children with camh challenges in the district. government stakeholders described particular challenges in engaging with caregivers of children and adolescents with mental health needs. many caregivers were yet to accept their children's conditions and struggled to comply with the prescribed treatment regimen, and highlighted below: "i love working with the children but some of the caregiver are in denial they don't adhere to what you tell them whether its homework, time keeping, bookkeeping. it's kind of frustrating because you know the child should be improving, but the child is not because the parent or caregivers are not adhering. " (psychologist ). the challenging nature of child and adolescent mental health conditions led to many of the caregivers describing feelings of concern, helplessness and exhaustion, as expressed below: "i cried a lot and even now i haven't accepted it because i have two children, both have same condition. i accepted with the first one, but i couldn't accept with the second one. it was really hard, and people were talking all they want about me and making fun of me that they rejected my children from school. " (caregiver ). the complicated nature and under-resourcing of camh conditions further have a substantially negative effect on educators, not to mention the critical weight such conditions have on children's functioning, daily interactions with their environment, emotions, behaviors and academic performance, resulting in, among others, poor academic performance, school truancy and dropout. the below quotation refers: "their conditions affect us a lot; particularly it makes me sad. it affects us to such an extent that we end up not knowing what to do because we encounter such problems each and every day and there is no way we can help the children. it also affects their academic performance many of them are not doing very well academically, and some of them exhibit some behavioral problems. sometimes we spend extra time to assist some of them, we visit their homes and even give some learners money to buy grocery. " (educator ). participants pointed to the lack of a coordinated system of camh care as a major barrier to providing and accessing camh services in the district. this was exemplified by, particularly, poor intersectoral collaboration, and the lack of a standardised procedure and coordination for delivering camh services across the various departments in the district. there were no adequately integrated procedures for managing and reporting camh cases. one participant referred to the overall system of care for children living with camh conditions in the district as "disjointed". an example of this disjointedness was that certain services were packaged for children in different age groups across the two hospitals, which often required caretakers to find means of transporting the children between the hospitals to access different specialist services. this is illustrated in the quotation below: factors that were perceived to impede camh service provisioning from the wider contexts of the district emerged. the coalescence of the district disease burden and resource shortages resulted in very limited health awareness being conducted, which in turn resulted in poor mental health literacy. tied to this barrier, it was often mentioned that there are high levels of stigma towards mental illness among children and adolescents, illustrated by the following: "she does get discriminated which is something that pains me a lot. we are even afraid to send her to the shops and they even discriminate her because of the school she is going to. " (caregiver ). dysfunctional family systems were raised as a major risk factor and barrier to accessing camh services for children. the participants particularly emphasized the absence of parents-leaving children to the care of grandparents and other family members or leaving adolescents to care for themselves as a major problem in the community. the following quotation illustrates this point: "…most are from broken families; they stay with elderly people and we've got children heading the family. " (principal). "some of the parents are not staying with their children, they work and stay out of town… they come on month ends-just providing money-and leave the children to guide themselves. some children are in distressful situations because they were in a way abandoned by their parents. " (sanca coordinator). the study sought to explore service providers and service users' experiences of providing and accessing camh services and their perceptions of the available camh services in the district using the health system dynamics framework. key barriers and facilitators emerged for camh in the amajuba district municipality. certain community factors such as low mental health literacy resulting in misconceptions and stigmatization, and the dysfunctional nature of the family system within the communities were highlighted as major camh risk factors within the district that impedes access to camh services. community-based stigma can prevent caregivers from seeking help for their children, heflinger and hinshaw [ ] stated that stigmatization increases the burden caused by mental illness and is a major barrier to accessing and utilizing mental health services. according to brannan and heflinger [ ] , caregivers of children with mental disorders often experience the pernicious impacts of stigma and therefore delay accessing mental health services for their children. the study further revealed that the shortage of resources particularly camh specialists, lack of intersectoral collaboration and poor coordination, financial restrictions, and the low priority given to camh services in the district negatively impacts on the state of camh and serves as barriers to accessing camh services in the district. nevertheless, the few available camh specialists were perceived to be competent and dedicated to delivering quality services but could benefit from systems strengthening initiatives that could expand the workforce and equip them with the required skills, resources and adequate coordination. these findings corroborate the findings of a recent study conducted in the western cape province of south africa by mokitimi et al. [ ] which highlighted inadequate camh resources, lack of priority for camh services and low levels of advocacy for camh services as major weaknesses of camh services in the province. the shortage of educational psychologists which resulted in inappropriate referrals, disruption of assessment procedures for children with intellectual disabilities and increased workload for the limited available clinical psychologists was reported as a major barrier to camh services by the doh stakeholders. hence, the need to employ more educational psychologists by the department of education to address the needs of children with learning challenges was suggested. stakeholders also suggested the provision of in-service camh training for psychiatric nurses, school health nurses, social workers and phc workers which could facilitate the adoption of a task-sharing approach considering the shortage of camh specialists in the district. while schools play a vital role in the identification and referral of camh challenges [ ] , the dbe stakeholders reported that they lack the required skills, time and tools to adequately screen and refer children thereby hindering many children and adolescents living with camh conditions from accessing the required camh services. the lack of appropriately defined referral pathways for children and adolescents identified as having mental health problems also emerged as a major barrier to providing adequate camh services within the school environment. as mentioned earlier, the majority of children within the school environment identified as in need of mental health services were referred directly to the hospitals which resulted in bottlenecks, with long waiting lists. therefore, the dbe stakeholders suggested that efforts to build teachers' capacity to facilitate early identification, screening and referral for children and adolescents at risk to optimize their health and development, as well as their academic potential, should be explored. this would assist the teachers to distinguish between learning problems that should be referred to educational psychologists, social problems that require social work interventions and mental health conditions that require the services of clinical/counselling psychologists. a study conducted by cappella et al. [ ] , emphasized the significant roles of teachers in delivering camh services. they proposed the use of an ecological model to strengthen teachers' capacity and facilitate active collaboration with mental health specialist for the reformation of schoolbased mental health services in low resource settings. the study underlined the lack of a coordinated and integrated system of camh services particularly the lack of collaboration between the different sectors providing camh services in the district. this lack of adequate coordination and collaboration accounts for the inadequate communication between the different sectors, undefined screening/assessment procedure and referral pathways which results in delayed access to mental health care and the development of required interventions to address the various conditions affecting children. this finding is similar to the findings of previous studies conducted in ghana, uganda, zambia and south africa [ , , ] which identified the consequences of a weak intersectoral collaboration for the delivery of mental health services particularly camh services in low resource settings. the study participants emphasized the impact of camh conditions on the academic performance of children and adolescents which is further compounded by the shortage of special schools, the difficulties associated with securing school placements, the inadequate attention paid to the quality of education obtained and the lack of opportunities to pursue higher or vocational education after completing basic education for children and adolescents with camh challenges. many children and adolescents living with learning disabilities are not receiving the required educational help for their special needs leaving them to helpless. this finding corroborates the findings of a study conducted in a south african peri-urban township by saloojee et al. [ ] who found that many children with intellectual disabilities are not enrolled in schools. the caregivers mentioned financial constraints, lack of knowledge on how to access the available services and lack of psychosocial support which they encountered daily in their pursuit to alleviate the conditions of their children. previous studies [ , , , , , ] have also highlighted the psychological, physical and financial burden associated with caring for people with mental health challenges and the need to develop interventions that would equip caregivers with skills to alleviate these burdens. caregivers are central to camh prevention and effective management but require consistent support to acquire the necessary coping, communication, resilience, problem-solving and stress management skills. moreover, the need for intensive camh awareness programs was suggested by the participants as well as the need to organize camh outreach teams to disseminate camh information and implement community based camh services in the district. according to the participants, these strategies will increase the knowledge of camh within the communities and could eliminate stigma and misconceptions around camh conditions. however, hinshaw [ ] proposed that stigma operates on multiple levels and mere public education programs might not resolve the problem of stigmatization. therefore, the need to incorporates different change strategies targeted at the different interacting levels within the communities is required. while a purposive sampling technique was used in selecting the study participants to obtain in-depth information on the current state of camh in the district, we acknowledge the various categories of stakeholders were a product of the differential availability of the stakeholders. it is possible that we might not have adequately captured the perspective of other key informants, particularly those within other sectors outside the dbe, doh and ngos/ cbos partnering with doh and dsd. however, the study included different categories of stakeholders to obtain rich data about the experiences and perceptions of camh service delivery in the district. the findings of this study suggest the need to create a district camh intersectoral coordinating or liaison forum to facilitate joint camh service planning and implementation to develop intersectoral agreements, developing defined referral pathways between relevant sectors, mobilizing resources, optimizing available resources within each sector, clarifying roles and responsibilities of the different sectors, promoting awareness and staff training on camh. moreover, the need for continuous in-service training and capacity building through supervision and mentorship for stakeholders in each of the sectors cannot be overemphasized as in-service training, mentorship and specialists support can facilitate the acquisition and the willingness to implement new skills. additionally, the development of management guidelines specifying the management procedures (identification, assessment, referral, treatment/interventions) for each sector and at the different levels of care should be prioritized. it is important to address the educational needs of children and adolescents living with camh challenges by mobilizing resources such as providing learning equipment, building more classrooms and creating professional support teams to expand the capacity of the available special schools to accommodate children and adolescents living with severe camh conditions specifically learning difficulties in the district. increased attention should also be paid to educating and providing the necessary socioeconomic support for caregivers of children and adolescent with camh conditions. caregivers should be sensitized about the importance of actively participating and complying with the management regimen recommended for their children's conditions within the health care system and school. it is also important to invest in a rigorous approach to disseminating mental health education especially camh information within the district to eliminate discrimination and stigma. these information dissemination strategies should include the transmission of camh messages using public-social media platforms, ensure regular camh information contacts at the community levels and provide adequate support and education at the family level. in conclusion, the need to build the capacity of all the involved stakeholders in relation to camh services is imperative in the district. although teachers and caregivers are not in a position to treat camh conditions, they can be equipped to identify children and adolescents with incipient mental health problems so that they access care early on in the illness progressions. they can also be equipped with knowledge and skills to support children and adolescents with mental health problems and adhere to management regimens. teachers could be assisted to promote mental health and resilience, identify and refer camh conditions through enhancing their mental health literacy and providing them with validated and appropriate screening tools. creating mental health outreach teams could further facilitate camh awareness within the communities thereby enhancing camh literacy and access to quality camh services. this could also potentially relieve the burden of care placed on the limited specialists and ensure a functional and sustainable collaborative system of camh care in the district. amajuba district municipality spatial development framework. 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up care for mental, neurological and substance use disorders publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we would like to thank all the study participants who devoted their time and insight, mr. mercury nzuza, miss. patricia ndlovu, mr. fortune ngubeni and miss. kgothalang rethabile khadikane for the support provided during the data collection phase. the views expressed do not necessarily reflect the uk government's official policies. the funder did not have any involvement in the study design, collection, analysis or interpretation of data or writing of the manuscript. gbb and ip conceptualised the study, gbb collected data, gbb and av analysed data and gbb drafted the manuscript. av, ab and ip reviewed the manuscript, provided substantive revision. all authors read and approved the final manuscript. this study is an output of the programme for improving mental health care (prime). this work was financially supported by the uk department for international development ( ). g. b. b receives the university of kwazulu-natal scholarship. the datasets used and analysed during the current study are available from the corresponding author on reasonable request. gatekeeper permission was obtained from the relevant government departments, and ethics approval was provided by the biomedical research ethics committee, faculty of health sciences, university of kwazulu-natal (reference number be / ). following an informed consent procedure, permission to participate and audiotape the qualitative interviews was obtained from each respondent. not applicable. the authors declare that they have no competing interests. key: cord- -zdw gt authors: mao, kang; zhang, hua; yang, zhugen title: the potential of an integrated biosensor system with mobile health and wastewater-based epidemiology (ibmw) for the prevention, surveillance, monitoring and intervention of the covid- pandemic date: - - journal: biosens bioelectron doi: . /j.bios. . sha: doc_id: cord_uid: zdw gt the outbreak of novel coronavirus pneumonia (covid- ) has caused a significant public health challenge worldwide. a lack of effective methods for screening potential patients, rapidly diagnosing suspected cases, and accurately monitoring the epidemic in real time to prevent the rapid spread of covid- raises significant difficulties in mitigating the epidemic in many countries. as effective point-of-care diagnosis tools, simple, low-cost and rapid sensors have the potential to greatly accelerate the screening and diagnosis of suspected patients to improve their treatment and care. in particular, there is evidence that multiple pathogens have been detected in sewage, including sars-cov- , providing significant opportunities for the development of advanced sensors for wastewater-based epidemiology that provide an early warning of the pandemic within the population. sensors could be used to screen potential carriers, provide real-time monitoring and control of the epidemic, and even support targeted drug screening and delivery within the integration of emerging mobile health (mhealth) technology. in this communication, we discuss the feasibility of an integrated point-of-care biosensor system with mobile health for wastewater-based epidemiology (ibmw) for early warning of covid- , screening and diagnosis of potential infectors, and improving health care and public health. the ibmw will provide an effective approach to prevent, evaluate and intervene in a fast, affordable and reliable way, thus enabling real-time guidance for the government in providing effective intervention and evaluating the effectiveness of intervention. the covid- pandemic caused by a novel coronavirus (sars-cov- ) has spread rapidly throughout more than countries and has led to a worldwide disaster. some dilemmas are associated with covid- care and management from the initial outbreak to the present situation, some of which have been resolved and some of which have not (more detailed description is seen in tab. s ). a good understanding of these dilemmas and putting forward solutions will help us face covid- and novel infectious disease epidemics in the future. it is critical to adopt strict and accurate public health measures for covid- care to address these difficulties and risks in the processes of prevention, diagnosis, intervention, and even therapy (dowell et al. ) . point-of-care (poc) biosensors may achieve the intended goal, enabling the convenient acquisition of both pathogen information and host-response information in almost any location in a short time, which has the potential to facilitate prevention and rapid diagnosis and intervention for covid- when combined with other useful technologies. we discuss the feasibility of an integrated poc biosensor system with mobile health for wastewater-based epidemiology (ibmw) for early warning of covid- , screening and diagnosis of potential infectors, improving patient health care and monitoring public health. . ibmw for the prevention, surveillance, monitoring and intervention of the covid- pandemic the first crucial step is the rapid and accurate diagnosis of covid- to screen potential patients, confirm suspected cases, provide timely health care/treatment, monitor and manage the epidemic (udugama et al. ) . biosensors offer great potential to meet diagnostic requirements (part s ) and can be used to detect covid- -related indicators (russell et al. devices that perform real-time diagnosis and detection; these include thermometers to measure body temperature and blood glucose meters to measure blood glucose and other conventional indexes. there are significant opportunities for biosensors to contribute to the rapid diagnosis and screening of infectious disease, in particular together with nanotechnology with an ultrasensitive detection of a range of disease markers (bhalla et al. ). however, the main difficulty is the need to quickly and effectively detect specific indicators of infectious diseases, such as pathogens. the results of these indicators will aid in the diagnosis of suspected and potential cases. biomarker quantification. a negative test is finished by adding the same channel and reaction cavity as the sample test process (seen in fig. s ). an integrated biosensor has the potential to rapidly diagnose pathogens and efficiently monitor infection transmission through self-tests performed outside the hospital. device integration can integrate all the steps of the biosensor into a small portable device, which is conducive to complex real-time diagnosis (kozel and burnham-marusich ) . recent advances in microfluidic technology (including paper microfluidic device) and nanotechnology have brought us closer than ever to the realization of simple yet highly sensitive and specific biosensors that can be used in min. their multiplex assay could concurrently detect four targets using a low sample volume in a resource-limited setting. these studies demonstrate that paper-based biosensors with the ability to perform fast, precise and high-quality diagnostics enable multiplex, sensitive, and selective analysis of infectious diseases and pathogens. in resource-limited areas, health care services may be overwhelmed; therefore, it is important to develop testing kits with the capability for self-detection. biosensors provide an important opportunity for family and community monitoring and have the potential to alleviate the current dilemma. at the same time, the use of biosensors to quantify host immune biomarkers in patients will aid in determining the severity of patients' symptoms, detecting the state of the host's immune system and identifying organ disorders, and this information can be applied to strategically allocate resources to optimize health care by adapting the classification process, the requirement for admission or effectiveness, and small sample requirements (yang et al. ). therefore, community sewage biosensors can be used to collect timely information about covid- for the whole community and report results to health institutions, facilitating early prevention measures and effects (fig. ) . if sars-cov- can be detected in the local community at an early stage through a community sewage biosensor, an effective intervention can be implemented in a real-time fashion, and restrictions on sars-cov- transmission will minimize the spread of the disease and the threat to public health. potential patients will also benefit from the community sewage sensor tracing of sars-cov- sources, which will provide information for accurate and timely treatment. patients report their self-test results to the hospital and public health management department through the mobile health system; then, the hospital puts forward diagnosis and treatment suggestions depending on the patient's actual situation (fig. ) . setting has abundant or limited resources, the application scope and capability of smartphones and their related technologies are increasing. currently, these smartphones offer low-cost sensing and processing capabilities comparable to expensive "high-end" devices. in addition, the mhealth system can also promote efficiency by improving the automation of inventory and supply chain management systems, reducing the workload and errors related to paper reports, and preventing materials from running out (namisango et al. ) . can monitor the epidemic with the real-time mhealth system and take appropriate measures, such as regional isolation and the allocation of strategic materials. all participants in the mobile system, including potential patients, medical staff and public health departments, can quickly understand the mobile health system, which can facilitate the diagnosis and treatment of potential patients. medical j o u r n a l p r e -p r o o f staff can better guide patients' health care, and public health departments can better monitor the epidemic and implement interventions such as the timely isolation of confirmed patients, protection of healthy people, and allocation of public resources. mobile systems, in combination with internet-connected diagnostic biosensors, provide new methods for the diagnosis, tracking, and control of infectious diseases while improving the efficiency of the health system (fig. ) . in addition, microfluidics sensing technology for effective drug screening and delivery holds the potential for therapy of sars-cov- . microfluidic chips afford considerable advantages in drug release, such as precise and multi-dosing release, targeted precise release, sustainable control of delivery, and small side effects, etc., which are important assets for drug delivery systems (see part s ). microfluidic technology has been gradually applied to the preparation of drug carriers, direct drug delivery systems, drug preparation and fixation. inexpensive and easily manufactured materials are rich substrates that naturally integrate multiple functions, which include filtration, storage, transport, valves, multiplexing, and concentration. microfluidics has great potential to be used in the research of covid- therapies to avoid ineffectiveness and health risks. effective prevention, monitoring, and interventions are important for slowing the spread of the disease and reducing the prevalence of covid- . we have proposed to use ibmw to provide an ideal framework to manage pandemics, from the perspectives of prevention, detection and intervention. the innovative miniaturization and portability of community sewage biosensors provide the possibility to trace potential sources in the field, and ibmw can directly identify pathogens and provide required biomarker data in a short period of time through self-testing. the real-time data collected and transmitted by the ibmw not only provide timely health care and treatment for patients but also allow for the timely implementation of epidemic control measures. covid- can be accurately controlled by public health prevention measures according to the epidemic situation in different regions. considering this timely information regarding the sars-cov- infection status and host reactions, the mhealth system can be used to monitor and control the epidemic. hence, the use of ibmw could reduce the time from the onset of infection to the appropriate therapeutics. in addition, the fast growth of microfluidic sensing technology has provided new opportunities for effective drug screening and drug release in in vitro tests, which will be beneficial for the development of effective therapeutic drugs and vaccines without a safety risk. the authors declare no competing financial interest. influenza other respir the authors declare no competing financial interest.j o u r n a l p r e -p r o o f key: cord- - b ids authors: paul, elisabeth; ndiaye, youssoupha; sall, farba l.; fecher, fabienne; porignon, denis title: an assessment of the core capacities of the senegalese health system to deliver universal health coverage date: - - journal: health policy open doi: . /j.hpopen. . sha: doc_id: cord_uid: b ids nan objective. by the end of june , an estimated . % of the senegalese population was covered by some form of social protection scheme for health [ ] . the senegalese health system has a pyramidal structure with three levels of care and a system of referral. health facilities comprise various levels of hospitals, health centres, health posts, plus hygiene and social services the administration of the health sector is also structured along three levels: central (ministry of health and social affairs -mohsa), intermediate ( regions ) and peripheral ( health districts) [ ] . the public health care system is complemented (particularly in dakar, the capital city) by a growing private sector which is estimated to represent nearly % of the total provision of health services and which is increasingly involved in the cmu policy [ ] . the health sector has experienced a number of reforms in the past decade, notably so as to facilitate the decentralisation policy whose implementation is still lagging behind [ ] . in addition, the coordination of the financial protection arm of uhc has been assigned to a separate cmu agency. the latter, which was initially created under the responsibility of mohsa, was transferred to the responsibility of the ministry of community development, social and territorial equity in april . this is meant to enable a separation of purchaserprovider functions and hence a strengthening of the control function, which is judged essential in the development of the social protection policy, as well as to improve the coherence of community development policies. the concept of uhc is closely linked to that of health system strengthening (hss). indeed, hss comprises the means (the policy instruments, i.e. "what we do"), while uhc is a way of framing the policy objectives (i.e. "what we want") [ ] . african countries face particular j o u r n a l p r e -p r o o f challenges with regard to the implementation of uhc because of substantial gaps characterising their health systems [ ] . the objective of this paper is to assess the main capacities of the senegalese health systems to deliver uhc, and as a corollary, to identify possible gaps and requirements in terms of hss necessary to implement and facilitate progress towards uhc. based on a critical review of existing data and documents, complemented by the authors' experience in supporting uhc policy making and implementation in senegal, we apply the world health organisation's conceptual framework based on six health system building blocks (leadership and governance; financing; health workforce; infrastructure, equipment, pharmaceuticals and medical products; health information; and service delivery) [ ] , enhanced by an analysis of the demand-side of the health system (characteristics and expectations of the senegalese populations) [ ] . indeed, this framework is commonly used by practitioners in francophone african countries, and was utilised to guide the situation analysis behind the elaboration of the recent national health sector development plan [ ] . the main question we intend to answer is the following: how far are the core health system capacities in place in senegal to deliver uhc? to do so, we have focussed on the main foundational and institutional bases facilitating the implementation of the uhc policy and as a corollary, on the bottlenecks hampering progress towards uhc. foundations are to be understood as the key basic health system related issues (like primary health care workforce, supply chains and diagnostic facilities, essential medicine, a unified information system, local health governance the world health organization [ ] . for each building block, we discuss a set of key indicators that have been identified by a working group within the world health organisation as being critical for health system strengthening, for adequately delivering health services in an appropriate and equitable way, and therefore for contributing to uhc. at the policy level, senegal adopted a national health policy in , which recognizes the right to health and entrusts the ministry of health with its implementation [ ] . it is implemented through a national health sector development plan, the third of which was adopted in and is called the plan national de développement sanitaire et social (pndss) - . it is based on three major axes which are: (i) the governance and financing of the sector; (ii) the provision of health and social action services, and (iii) social protection in the sector. this decennial strategic plan is further declined in multi-annual expenditure programming documents, specific strategic plans and operational plans at various levels [ ] . a draft law aimed at instituting the cmu had been prepared as a specific legal framework. nonetheless, following the transfer of the cmu agency to the responsibility of the ministry of community development, social and territorial equity, that draft law will be integrated into a more holistic legislation on social protection (under construction at the moment). it is planned to specify that all residents are entitled to a financial protection regime. at the institutional level, a number of stakeholder coordination committees meet regularly and provide policy advice to the mohsa. other health-related sectors participate in the joint annual review at both the national and regional levels. at the local level, the former (and under-performing) "health management committees" were replaced in by "health j o u r n a l p r e -p r o o f development committees" which provide a consultation framework between communities and the local elected officials with responsibilities in the field of health [ ] . inter-sectoriality is facilitated at local level because the district working plans are integrated with the (intersectorial) annual local development plans. the district health management teams run monthly district coordination meetings, and communities participate in local health management committees [ ] . health development committees now exist in every health centre and health post. at the operational level too, a number of institutions are in place to ensure clinical practice and quality control. standards, norms and therapeutic protocols are in place in various fields, and are regularly updated. in addition, there are mechanisms to authorise, audit, monitor and evaluate providers according to standards. a reflection is led on how to improve the respect of norms and the quality of services provided in private health care facilities in the context of the public-private partnership, which has been developed to enable expansion of the cmu policy [ , ] . the cmu policy specifies that private health facilities and pharmacies can apply for recognition by the cmu agency, which may subsequently withdraw or suspend accreditation. there are mechanisms to represent the interests of patients and the population in general, as well as the interests of providers in the health system, notably a civil society organisation platform (called congad) and trade unions. overall, the health sector in senegal has appropriate policies and institutions in place to allow for good governance and to facilitate progress towards uhcat least formally. however, based on our appraisal of the situation, two important issues weaken the governance of the health and social protection sectors in senegal: on the one hand, severe disparities in the way in which resources are allocated and managed in the sector and across regions [ , ] ; and on j o u r n a l p r e -p r o o f the other hand, the fragmentation of the institutions in charge of managing and implementing the various aspects of the overall uhc policy. indeed, while the mohsa is responsible for expanding the supply of health services, the cmu agency is in charge of coordinating the various financial protection regimes. in practice, four regimes coexistcompulsory health insurance, medical assistance, community-based health insurance (cbhi) and commercial health insurance (see below)but they are managed by various organisations without effective coordination to date. yet, the cmu policy is constantly evolving so as to respond to the emerging challenges, especially to better integrate the various schemes (e.g., transfer of medical assistance schemes to state-subsidised cbhi affiliation) [ ] . finally, as for the outcomes of the cmu policy, by the end of june , it was estimated that close to % of the senegalese population was covered by some form of social protection regime, with close to % of the total population covered by cbhi [ ] . there are important issues and gaps regarding the financing of the health system in senegal. epidemiological profilefor instance, because insufficient funding (less than % of total current expenditure) was dedicated to reproductive health [ ] . as regards the pooling of resources, the various health insurance and medical assistance schemes in senegal are fragmented, each scheme has its own operating mechanism without interconnection [ ] , which reduces the overall efficiency of the system. this is compounded by a lack of progressivity of the health financing system and especially, insufficient targeting of the medical assistance systemfor instance, all children under five and all people above are entitled to free healthcare, whatever their socio-economic status [ ] . the four major schemes are the following: (iv) commercial health insurance: these schemes generally cover individuals with a relatively high level of income. despite the attractiveness of the benefit packages offered and the professionalism of the management, they cover a very small part of the population, so that the fragmentation of the risks covered and the high premium levels limit the potential for private for-profit health insurance to make a significant contribution to extending health risk coverage [ ] . uhc through a good supply of qualified human resources throughout the country [ ] . today, the computerisation of human resource management is a reality, with the appointment of human resource focal points at the district, medical region and hospital levels, and the use of the ihris software, although challenges persist in terms of its implementation in dakar [ , ] . there have been a few wage delays: according to a survey undertaken in , some % of staff reported a delay of at least two months in paying their wages [ ]. however, there are also a number of problems in this regard. human resource allocation is inequitable and does not reflect regional disparities in the burden of disease distribution [ ] . indeed, senegal faces major problems with regard to the retention of human resources in disadvantaged areas. moreover, efforts to produce human resources are not always followed by recruitment [ ] . the directorate of pharmaceuticals and medicines is the national drug regulatory authority, whose mission is the preparation, implementation and monitoring of policy and programs in the field of pharmacy and medicines (https://www.dirpharm.net/index.php/dpm/presentation). the pharmacie nationale d'approvisionnement (pnacentral medical store) is the j o u r n a l p r e -p r o o f wholesale distributor for the public sector, and also supplies the private sector with generic essential medicines. over the past decade, the pna has implemented several strategies to make medicines and essential products available and accessible. it has strengthened the territory's network by setting up eleven regional pharmacies, sales depots in health care facilities, and piloted innovative initiatives aimed at bringing the services closer to clients and to improving the availability of medical products [ ] . [ ] . nevertheless, a service availability survey at the facility level showed that availability is good for certain drugs and essential products (e.g. antibiotics for adults) but not for others (e.g. antibiotics for children). many essential drugs j o u r n a l p r e -p r o o f were available in less than half of the health facilities. among the health facilities that provide infant immunisation services and routinely stockpile vaccines, for instance, % of the facilities had all the basic vaccines available on the day of the survey [ ] . finally, the balance between regulation and autonomy often hampers effective management as well as relationships between pharmaceutical private entities and national authorities. the government of senegal has already taken the necessary preliminary steps to engage the private sector in order to ensure the introduction of new models for collaboration [ ] . the or treatment services ( %) and curative care services for sick children ( %). antenatal care ( %), family planning ( %) and child growth monitoring services ( %) are available in more than % of facilities. however, there is a s lower availability of specific services such as normal delivery and new-born care ( %) [ ] . it has to be noted that in the context of the national financing strategy for uhc [ ] , publicprivate partnerships were developed in order to extend the range of services offered as a complement to the public health system. for instance, the senegalese sovereign investment ( %) than in hospitals ( %), which is consistent with the national policy [ ] . note however that health services must be of a sufficient quality to achieve impact. a recent study estimates that the effective coverage of primary health servicesthat is, adjusted to take quality into accountis only % on average in senegal [ ] . [ ] . the senegalese government is aware of the importance of social determinants of health, and reckons that they should be an important part of the uhc policy. indeed, the dhs shows important disparities in health care utilisation and health outcomes between regions, living environments, education levels, wealth quintiles, as well as according to individual behaviours. despite the policies implemented to expand health service coverage and improve financial risk protection, % of surveyed women aged - have at least one problem with j o u r n a l p r e -p r o o f access to health care, including financial accessibility ( %), geographic accessibility related to distance ( %), not wanting to go alone ( %) and obtaining permission to seek care ( %) [ ] . three problems have been identified in this respect: (i) the non-functionality of multi-sectoral frameworks at national level does not significantly mitigate risks related to population health determinants; (ii) the ineffectiveness of health promotion initiatives contributes to increasing individuals' exposure to the effects of behavioural determinants; (iii) the lack of common and inclusive strategies with regard to health system determinants limits efforts to rationalise health expenditures [ ] . experience worldwide shows that the path towards uhc is context-specific and pathdependent [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . in particular, there is no generalizable evidence neither as to whether it is preferable to rely on a tax-based or social health insurance system so as to increase compulsory prepayment for uhc; nor as to whether service provision should be based on a national insurance system that purchases services from public and private providers, or on a public delivery system [ , [ ] [ ] [ ] . moreover, since countries usually adopt mixed financing schemes, it is acknowledged that policies should approach the system as a whole, and not focus on individual schemes [ ] . there is no "magic bullet" solution to achieve uhc, and there is no consensus on the effectiveness and feasibility of most individual strategies considered to achieve progress in terms of that objective [ ] . has an effect on the overall system"hence the need to view them together when designing policies and monitoring progress towards uhc [ ] . for instance, substantial disparities characterise financing resource allocation in the health sector, and health risk protection schemes are highly fragmented (especially cbhis)which means that the pooling of funds is not carried out at a sufficiently high level to ensure cross-subsidisation and the reduction of financial risk [ ] . these "upstream" constraints in terms of governance and resource allocation have negative effects on the rest of the health systemfor instance, on the distribution of the health workforcedown to service delivery and consequently, health outcomes [ ] . moreover, by definition, a system is just as weak as its weakest element, so that the health system should be supported through all its elements. to apprehend the contribution of the various building blocks to uhc, other authors have developed a composite index comprising indicators of health service delivery, infrastructure, human resources, and health expenditures; using such an index, overall service coverage score is estimated at . in senegal, compared to . for benin, . for cameroon, and . for côte d'ivoire [ ] . health systems comprise an infinity of dimensions. consequently, this paper has focused on a number of institutional and foundational indicators that have been identified as being critical for hss and thus for uhc, but which are, by definition, incomplete. the readers may therefore be a bit frustrated not to get more information on each building block. moreover, although all the authors have long experience in studying and/or supporting the health sector and uhc policies in senegal and elsewhere, and have tried to make as objective an j o u r n a l p r e -p r o o f assessment as possible, our assessment could have been stronger if shared and discussed with a wider audience. despite these limitations, this paper offers interesting insights into a number of policyrelevant issues that may guide the senegalese authoritiesas well as inspire authorities from other countries with similar contextsin the progressive adaptation of their uhc policy. indeed, experience from other countries corroborate the view that similar systemic constraints hamper progress towards uhc. regarding governance, the literature is quite consistent in pointing to the fact that progress towards uhc needs above all a strong political commitment including pressure from civil society [ , , [ ] [ ] [ ] , which then has to translate into sound policy and planning documents, adequate supportive legislation, inclusive coordination mechanisms and intelligence based accountability. the financing aspects of uhc are also very much developed in the recent literature; indeed, a major challenge for many countries is to move away from out-of-pocket payments and develop prepayment and pooling, but also to shift to strategic purchasing and improve financial management systems in such a way as to improve health spending efficiency [ , , , , [ ] [ ] [ ] . reducing the fragmentation of financial protection regimes has also been identified as important when it comes to reducing disparities, even if difficult to implementindeed, once different pools have been established, it is politically difficult to integrate or harmonise them because integration involves the redistribution of resources across organised interest groups [ , , , ] . human resources for health are necessary for the availability and the quality of health services; yet, many countries facing human resource gaps ought to match their commitment to uhc with their capacity to deliver health services, depending on the availability of a qualified and motivated health workforce [ , ] . the health information system 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coverage and intersectoral action for health: key messages from disease control priorities key: cord- -fu n p authors: séroussi, brigitte; hollis, kate fultz; soualmia, lina f. title: transparency of health informatics processes as the condition of healthcare professionals’ and patients’ trust and adoption: the rise of ethical requirements date: - - journal: yearb med inform doi: . /s- - sha: doc_id: cord_uid: fu n p objectives : to provide an introduction to the international medical informatics association (imia) yearbook by the editors. methods : this editorial provides an introduction and overview to the imia yearbook which special topic is: “ethics in health informatics”. the keynote paper, the survey paper of the special topic section, and the paper about donald lindberg’s ethical scientific openness in the history of medical informatics chapter of the yearbook are discussed. changes in the yearbook editorial committee are also described. results : inspired by medical ethics, ethics in health informatics progresses with the advances in biomedical informatics. with the wide use of ehrs, the enlargement of the care team perimeter, the need for data sharing for care continuity, the reuse of data for the sake of research, and the implementation of ai-powered decision support tools, new ethics requirements are necessary to address issues such as threats on privacy, confidentiality breaches, poor security practices, lack of patient information, tension on data sharing and reuse policies, need for more transparency on apps effectiveness, biased algorithms with discriminatory outcomes, guarantee on trustworthy ai, concerns on the re-identification of de-identified data. conclusions : despite privacy rules rooted in the health insurance portability and accountability act of (hipaa) in the usa and even more restrictive new regulations such as the eu general data protection regulation published in may , some people do not believe their data will be kept confidential and may not share sensitive information with a provider, which may also induce unethical situations. transparency on healthcare data processes is a condition of healthcare professionals’ and patients’ trust and their adoption of digital tools. every year, the international medical informatics association (imia) yearbook choses a special topic to focus on a specific thematic area related to health informatics practices. after "learning from experience: secondary use of patient data" in , "between access and privacy: challenges in sharing health data" in , and "artificial intelligence in health: new opportunities, challenges, and practical implications" in , the special topic of the yearbook appeared as a fitting culmination of the preceding topics. embedding data access versus privacy concerns -especially in the case of data secondary use -on the one side and the new challenges of artificial intelligence (ai) in health applications, on the other side, the yearbook special topic "ethics in health informatics" (ehi) was obvious to the yearbook editorial committee and supported by imia working group chairs and co-chairs. ethics may be defined as the moral principles that govern a person's behavior or the conducting of an activity. according to the merriam webster, ethics and morals are often regarded as synonyms. more specifically, medical ethics, which spirit is included in the hippocratic oath, is known to rely on four pillars: (i) autonomy, e.g., patients but also physicians should keep their autonomy of thought, intention, and action when making decisions regarding health care procedures; (ii) justice, e.g., burdens and benefits of health care procedures, especially treatments, must be distributed equally to be fair with all players involved; (iii) beneficence, e.g., health care procedures are provided with the intent of doing good for the patient involved; and (iv) non-maleficence, e.g., health care procedures should not harm the patient involved. inspired by medical ethics, ethics in health informatics progresses with the advances in biomedical informatics. previ- objectives: to provide an introduction to the international medical informatics association (imia) yearbook by the editors. methods: this editorial provides an introduction and overview to the imia yearbook which special topic is: "ethics in health informatics". the keynote paper, the survey paper of the special topic section, and the paper about donald lindberg's ethical scientific openness in the history of medical informatics chapter of the yearbook are discussed. changes in the yearbook editorial committee are also described. results: inspired by medical ethics, ethics in health informatics progresses with the advances in biomedical informatics. with the wide use of ehrs, the enlargement of the care team perimeter, the need for data sharing for care continuity, the reuse of data for the sake of research, and the implementation of ai-powered decision support tools, new ethics requirements are necessary to address issues such as threats on privacy, confidentiality breaches, poor security practices, lack of patient information, tension on data sharing and reuse policies, need for more transparency on apps effectiveness, biased algorithms with discriminatory outcomes, guarantee on trustworthy ai, concerns on the re-identification of de-identified data. conclusions: despite privacy rules rooted in the health insurance portability and accountability act of (hipaa) in the usa and even more restrictive new regulations such as the eu general data protection regulation published in may , some people do not believe their data will be kept confidential and may not share sensitive information with a provider, which may also induce unethical situations. transparency on healthcare data processes is a condition of healthcare professionals' and patients' trust and their adoption of digital tools. informatics, medical; health information technology; imia yearbook of medical informatics; artificial intelligence; data sharing; ethics tified form (often without any disclosure to, or consent from, the individuals using the applications) while it has been proven that re-identification is often possible with really low effort [ ] . anonymization is indeed difficult in regard to large data collections as (for example genetic) data may affect not only the privacy rights of individuals but also the rights of whole groups for ethnic or geographic reasons [ ] . furthermore, "big data" approaches challenge the established science paradigm, leading to new forms of empiricism that declare the creation of a science based on data rather than knowledge [ ] . the european commission has recently questioned the principle of a trustworthy artificial intelligence with the publication of ethics guidelines [ ] putting forward a set of key requirements that ai systems should meet in order to be deemed trustworthy. interestingly, one is about the need for human agency and oversight (human-in-the-loop, human-on-the-loop, and human-in-command) and the need for transparency (ai systems and their decisions should be explained in a manner adapted to the stakeholder concerned). explainable ai has thus to progress if human healthcare providers have to explain to their patients how machine learning models often thought of as "black boxes" are reasoning behind their predictions to comply with the autonomy pillar of medical ethics. another issue relies on the identification of ways in which a deep learning algorithm embeds racial, ethnic, gender, or other biases which shape or corrupt its results and erode public confidence in the implementation of ai systems. lastly, there are also growing concerns about the "de-skilling" of physicians that could occur when some or all of the tasks become automated, such as a drop in a clinician's diagnostic accuracy. threats on privacy, confidentiality breaches, poor security practices, lack of patient information, tension on data sharing and reuse policies, need for more transparency on apps effectiveness, biased algorithms with discriminatory outcomes, guarantee on trustworthy ai, concerns on the re-identification of de-identified data, all these issues are critical to medical practice as some people may not seek care or share sensitive information with a provider if they do not believe their data will be kept confidential [ ] . studies have reported that patients may not disclose clinical information to healthcare providers to protect against the perceived ehr privacy and security risks despite ehr advantages for promoting quality of care [ ] . on the other hand, insufficient use of digital technology in patient care, for research, or to support the development of a data-driven care system management may also induce, on a large scale, unethical situations. indeed, not receiving benefit from ai applications that hold the promise of improving safety, fairness, and welfare is unethical. besides, ai applications have the potential to reduce present-day discrimination caused by human subjectivity. for all these reasons, the special topic, ethics in health informatics, for the imia yearbook could not have been more timely. this year's keynote paper written by kenneth w. goodman presents an optimistic view of how the insights and analyses provided by ethics are currently incorporated by academic and health care institutions. this position is illustrated by different contemporary challenges including artificial intelligence and machine learning; big data, data sharing and privacy; duties to use and manage new technology; and ethics and public policy. the keynote paper proposes commandments in the development and use of machine learning programs, including "quality and standards are ethical issues", "prevent and eliminate bias", "use machine learning software for good and not evil", "insist on and provide robust education and evaluation". interestingly, the duties to use information technology because "its advantages outweigh its disadvantages" are illustrated by the learning health system paradigm that advocates the overarching duty to use tools that improve health. ously, ehi was essentially concerning data privacy. when there was one care provider for one patient, maintaining the security and confidentiality of patient records was essentially based on the conversational discretion of the health care provider and the physical security of paper-based medical records. the advent of electronic health records (ehrs) has raised new concerns about privacy. now that a patient is being cared for by multiple care providers in different settings, data privacy concerns have been extended to include security and confidentiality issues at the moment of data sharing and exchange among the members of the healthcare team in charge of a given patient. going further, the implementation of the learning health system (lhs) paradigm (an evidence-building system able to learn from every patient encounter "best practices seamlessly embedded in the delivery process and new knowledge captured as an integral by-product of the delivery experience" [ ] ) is another example of health information and data re-use that could, as in the rapid deployment of cloud computing, potentially lead to data privacy breaches. despite privacy rules rooted in the health insurance portability and accountability act of (hipaa) in the usa that restrict the sharing of identifiable health data, and even more restrictive new regulations such as the eu general data protection regulation published in may (gdpr) that led to a renewed focus on balancing privacy and sharing of personal data, novel technologies have the potential to enable the automated collection and analysis of health data. are patients aware about how their data are being used and by whom? for instance, patients and their family members are often not informed about or asked to consent to the use of ai-powered decision support tools -many of them unproven -in their care [ ] . is consent for personal healthcare data processing actually always collected? is data processing performed the right way (data minimization, accuracy, storage limitation, etc.)? one can wonder whether healthcare data can be private when wearables and mobile apps collect health data that can be shared for advertising purposes in de-iden-transparency of health informatics processes as the condition of healthcare professionals' and patients' trust and adoption: the rise of ethical requirements in keeping with the theme of this year's edition of the yearbook, dr galvin and dr demuro offer a survey in the special section about the issues regarding privacy protections and data ownership in mobile health (mhealth) technologies. they observe that the security of mhealth data storage and transmission remains a concern. consumers are often uneducated regarding the ways a service may collect and transmit their data to third parties. they introduce the concept of a "health care fiduciary" as a means to protect the basic human right of privacy in an equitable fashion across a dynamic ecosystem. ethics in health informatics, as perceived though the lens of clinical research informatics (cri), is described by dr anthony solomonides in the survey paper of the cri section. the paper proposes a personal view on artificial intelligence, machine learning, and big data analytics and describes the shift of ai from logic to data with the counterpart of biases and currently unsatisfied though essential needs for explanation. the role of common data models is emphasized as a way to organize and store data in a highly standardized form, to foster clinical research on "real world data" and accelerating observational studies. then, the section on phenotyping and cohort discovery introduces the issue of de-identification which efficacy is counterbalanced by the availability of data sets and methods allowing to link individuals in one data set to those in the supposedly de-identified collection leading to re-identification. although blockchain has been suggested as a possible answer to the challenges of anonymous data sharing, it has not yet had wide adoption in the field. in the history of medical informatics chapter of this year's yearbook, dr kulikowski provides historical insight into the scientific, technological, and practical clinical accomplishments of donald lindberg. how dr lindberg opened free access and worldwide public dissemination of all the nlm's biomedical literature and databases is presented as an example of ethical scientific openness checking the four pillars autonomy, justice, beneficence, and non-maleficence. dr sabine koch provided her inaugural imia president's statement. beyond some very thoughtful reflections about the rapidly evolving biomedical and health informatics field and the continuously arising new challenges that have to be faced, she offered some important information about imia. one piece of importance is the formal statement submitted by the imia's academy to the world health organization (who) in response to the current covid- global pandemic. the statement emphasizes the use of health informatics methodology and information and communication technology in combating the current covid- pandemic and future outbreaks. other imia's initiatives are described including the preparation of medinfo . the edition of the imia yearbook includes two papers from the international academy of health sciences informatics (iahsi). the first one authored by the members of the academy's first board including elected and ex officio members provides a summary of the major academy activities in and and an outline of the actions planned for , showing that the academy is completely established and that progress is now on track. the second paper is an edited version of the academy 'strategy and focus areas' document reflecting major outcomes of intensive discussions that occurred during and presented at the academy's rd plenary during medinfo . regardless the 'living document' nature of the 'strategy and focus areas' document, academy fellows decided that this current first version describing iahsi vision, mission, principles, values, and strategic directions would be used as a base for decisions on future activities. as every year, some changes would occur in the yearbook editorial team. in , the two co-editors of the decision support (ds) section were vassilis koutkias, researcher in biomedical informatics at certh/inab (thessaloniki, greece) and catherine duclos, professor in biomedical informatics at sorbonne paris nord university (paris, france). we are really sad and it is painful to remind yearbook readers that vassilis passed away in december leaving a huge void in our hearts and a deep sorrow for many members of the yearbook editorial committee. an obituary in his memory is included in this year's yearbook. we want to thank jacques bouaud, researcher in biomedical informatics at the limics (paris, france), who has been serving as ds section co-editor since . jacques has been a true pillar of the editorial committee, always available for any section editor, especially to help in the implementation of the yearbook method to conduct the literature search for the selection of best papers. despite he decided to leave the editorial committee in , he accepted to work with catherine duclos to replace vassilis and finish the work on the ds section. our thanks go also to the two editors of the bioinformatics and translational informatics section, malika smaïl-tabbone, associate professor of computer science at lorraine university (nancy, france), and bastien rance, associate professor of biomedical informatics at paris university (paris, france) that would leave the yearbook editorial committee in . we also want to thank the co-editors of the public health and epidemiology informatics (phei) section, rodolphe thiébaut, professor of public health and biostatistics at the university of bordeaux (france) and sébastien cossin, assistant in public health informatics at the university of bordeaux (france) that leave the yearbook editorial committee. in , the special topic of the yearbook is "managing pandemics with health informatics: successes and challenges", thus there will not be a phei section on top of the special section. finally, after four years as a chief editor ( - ), and four years as imia vp services ( - ), brigitte séroussi is leaving the yearbook editorial committee on november . a new imia vp for services will be elected at the next imia general assembly meeting that will take place in hamamatsu (浜松) (japan) during the apami , th biennal conference of the asia-pacific association for medical informatics. toward an information infrastructure for global health improvement feasibility of reidentifying individuals in large national physical activity data sets from which protected health information has been removed with use of machine learning from genetic privacy to open consent big data, new epistemologies and paradigm shifts how should health data be used? privacy, secondary use, and big data sales the double-edged sword of electronic health records: implications for patient disclosure key: cord- -rw keyos authors: tao, wenjuan; zeng, zhi; dang, haixia; lu, bingqing; chuong, linh; yue, dahai; wen, jin; zhao, rui; li, weimin; kominski, gerald f title: towards universal health coverage: lessons from years of healthcare reform in china date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: rw keyos universal health coverage (uhc) is driving the global health agenda. many countries have embarked on national policy reforms towards this goal, including china. in , the chinese government launched a new round of healthcare reform towards uhc, aiming to provide universal coverage of basic healthcare by the end of . the year of marks the th anniversary of china’s most recent healthcare reform. sharing china’s experience is especially timely for other countries pursuing reforms to achieve uhc. this study describes the social, economic and health context in china, and then reviews the overall progress of healthcare reform ( to present), with a focus on the most recent ( ) round of healthcare reform. the study comprehensively analyses key reform initiatives and major achievements according to four aspects: health insurance system, drug supply and security system, medical service system and public health service system. lessons learnt from china may have important implications for other nations, including continued political support, increased health financing and a strong primary healthcare system as basis. universal health coverage (uhc) is driving the global health agenda and is now an ambition for many nations at all stages of development. uhc is a means for achieving improved equity, health, financial well-being and economic development, ensuring that everyone has access to quality, affordable health services when needed. most countries have made uhc a key global health objective through the united nations' resolution, and move towards uhc following the sustainable development goals (sdg) set in . at the beginning of the st century, the push for uhc seems stronger than ever. the new who director general, dr tedros, emphasised that uhc is the 'top strategic priority' in the road map for who's renewal. accordingly, who's general program of work for - has set an ambitious goal of benefiting more than billion people from uhc by . who states that there is 'no one size to fit all'-there are different ways to attain uhc. an increasing number of low and middle-income countries (lmic) are actively pursuing policies to achieve uhc and share their implementation experience from different political settings, such as turkey, indonesia, thailand and bangladesh. according to the world bank report, the march to uhc in china is unparalleled. also, yip et al commented that 'china's reform goals and systemic strategies are exemplary for other nations that pursue uhc.' in early , the chinese government launched a new round of health system reform with the goal of providing affordable and equitable basic healthcare for all by , which is in line with the basic concept of uhc defined by who. this year marks the th anniversary of china's most recent healthcare reform. evidence from china is especially timely for countries pursuing uhc. however, much of the early research focused solely on the first -year reform after in china, summary box ► continued political support is the most important enabling condition for achieving universal health coverage (uhc). china has shown clear political willingness to make uhc achievement a more countryled process. ► increasing health financing is necessary, and the investment from both government and private sector is considered. ► a strong primary healthcare system should be regarded as a core component in realising uhc. the chinese government has made primary healthcare a priority in its 'healthy china ' strategy. ► some lessons providing reform experiences for other countries include the pilot reform and systematic reform strategy. without addressing the issue of the reform evolution and progress during the past decade. there is inadequate understanding of how china moves towards uhc step by step. we undertook a literature review, and analysed policies and secondary data from governmental sources. we aim to share the complete experience and strategy about china's healthcare reform, and provide the critical lessons for other nations, especially for lmics. the people's republic of china (prc) covers approximately . million km , and is now the most populous country in the world with . billion people. the urban population accounts for . % of the total population. prc was founded on october . at the time, china had one of the world's poorest healthcare delivery systems due to an economy weakened by war. today, china is an upper middle-income country whose gross domestic product has grown substantially at an average annual rate of . % over the past years, and has lifted more than million people out of poverty. with the rapid economic growth, china has made great efforts to achieve uhc. for example, china has devoted increased public funding to health-the largest increase among brazil, russia, india, china and south africa countries. china has almost achieved all of the millennium development goals (mdg) by , making a major contribution to the achievement of the mdgs globally, and is now moving towards sdgs to achieve uhc by . table illustrates a summary of key socioeconomic and health indicators in the country from to , as well as the comparable data in the other emerging (e ) countries (india, brazil, mexico, russia, indonesia and turkey) in . china has experienced remarkable improvements in economic conditions, human development and health outcomes, such as life expectancy and mortality. compared with other e countries, china is at a relatively good level in both its economy and population health. since the founding of the prc in , china has experienced dramatic changes in its healthcare system. like many other countries, china's healthcare reform has also undergone a difficult exploratory process. therefore, it is necessary to briefly review the progress of reform of the healthcare system over the past years. we divide the progress of china's healthcare reform into three stages. stage : years after the founding of people's republic of china ( china ( - at the founding of prc, with a weak foundation, the state developed a centrally planned socialist system, emphasising public ownership and welfare, mass-based collectivism and egalitarianism. in the health sector, the government managed a centrally directed health delivery system, and defined four principles to guide health and medical work: ( ) serve the workers, peasants and soldiers; ( ) put prevention first, in particular through the patriotic health campaigns; ( ) integrate traditional chinese medicine with western medicine; and ( ) combine health work with mass movements. these principles of healthcare delivery reform contributed to rapid improvement in the health of the population, creating some reform models (eg, 'barefoot doctors', 'cooperative medical system' and 'threetier health service delivery system') that were highly valued by the who. during this period, despite a shortage of healthcare resources, china's healthcare bmj global health system achieved almost universal access to healthcare and preventive services, producing impressive health gainsfor example, dramatically increased life expectancy and decreased infant mortality. stage : years after the 'reform and opening up' policy beginning in , china began its 'reform and opening-up' policy, ushering in a socialist market economy that encouraged a free market and focused on economic growth. this led to a fundamental transformation of the chinese healthcare system and had a profound impact. with privatisation and marketisation, the changes in the healthcare system included: a shift from public financing to private sources; a reorganisation of public hospitals and clinics into commercial enterprises; decentralising healthcare governance to local governments; and a pricing policy that enabled facilities to gain profits. these changes helped expand healthcare resources and improve medical technology and equipment, but also posed many problems (eg, reduced government expenditure on healthcare, less emphasis on rural areas and public health, and overutilisation of unnecessary or expensive care), - resulting in a series of adverse effects, such as increased disparities between rural and urban residents, a decline in public health, rising healthcare costs and sharp decreases in insurance coverage. in , the severe acute respiratory syndrome epidemic revealed weaknesses in china's health system and focused a domestic and international spotlight on those weaknesses. this wake-up call opened a window of opportunity for a new round of healthcare reform. it is an unprecedented health system transformation towards uhc, aiming to provide universal coverage of basic healthcare by the end of . following extensive interagency consultation and public debates, this launch emphasised a return to government-led, people-centred healthcare and healthcare as a public good. the latest round of healthcare reform adopted the 'best fit' with the existing institutional and policy frameworks towards achieving uhc by an incremental approach (step by step), which was recommended by the who team. the 'opinions on deepening the health care system reform' that were promulgated by the central committee of the communist party of china (cpc) and the state council marked the start of china's new healthcare reform. the comprehensive reform plan can be summarised as 'one goal, four beams, and eight columns' (figure ). under the goal of achieving uhc, china concentrated on establishing the four systems (ie, public health service system, medical service system, health insurance system, and drug supply and security system), based on the eight functional mechanisms that could provide essential supports. accordingly, three sequential phases of healthcare reform plans were to be carried out to achieve the overall goal by : the - phase, the - phase and the - phase (figure ). bmj global health the - phase the first -year reform plan laid a foundation for the goal. there were five reform priorities: ( ) accelerating the establishment of a basic health insurance system; ( ) establishing a preliminary national essential drug system; ( ) improving the primary care delivery system to provide basic healthcare; ( ) making basic public health services (bphs) available and equal for all; and ( ) piloting public hospital reforms. reforms during this first phase focused on strengthening primary care. this phase of reform obtained positive evaluations and was confirmed to be heading in the right direction by who and others. the - phase the second phase of healthcare reform, china's ' th five-year plan', continued in the same general direction. the reforms were promoted and deepened during this period, and clarified three tasks: ( ) basic health insurance for all; ( ) consolidation and improvement of the essential drug system; and ( ) reform of public hospitals. the focus of reform gradually shifted from primary care to the public hospitals, especially county public hospitals. the county public hospitals lead the reform of public hospitals through subsidising medical services with profit from drug sales, and comprehensively promoting the reform of the management system, compensation mechanism, personnel distribution, procurement mechanism and price mechanism. the - phase following the reform tasks specified at the third plenary session of the th central committee of the cpc in , the ' th five-year plan on deepening the health care system reform' marked the beginning of the third phase, a comprehensive drive for deeper reform. the reform of this phase focuses on the transitions from: ( ) laying a solid foundation to improving quality; ( ) framework formation to system construction; and ( ) singlearea breakthroughs to system integration and comprehensive promotion. 'tripartite system reform (tsr)', which refers to the linkage reform of the medical care, main reform initiatives achievements expanding the population coverage of the basic health insurance schemes. more than % of the population covered by social health insurance schemes in . extending the health service package of the basic health insurance schemes. the number of pharmaceuticals on the drug list was expanded to in ; government subsidies per capita for the urbmi and nrcms have increased more than fivefold in compared with . developing the mfa for people living in extreme poverty. in , a total of ¥ . billion was spent from medical assistance funds nationwide to subsidise . million people to participate in basic medical insurance, and . million people received outpatient and inpatient assistance. developing the cmi for those people with catastrophic medical expenditure. since , cmi has covered . billion people in china and benefited more than million people ( % of whom are rural residents), and reimbursement payments have exceeded ¥ billion. integrating basic health insurance systems of rural and urban residents: merging nrcms and urbmi into the urrmi. unifying insurance coverage, funding policies, insured treatment, reimbursement catalogues, management of contracted medical institutions and fund management: for example, the number of drugs covered in the insurance drug list is unified to in , and the per-capita premium is unified to ¥ in . reforming the payment system. % of public hospitals above the second level have carried out reforms of the disease category-based insurance payment in ; announcing a list of pilot cities for drg payment reform in . zero mark-up policy on drug sales. all public hospitals nationwide have removed the medicine mark-ups in . formulating and expanding the neml. issuing a revision of the neml in including a list of essential medicines, and expanding the list to medicines in and medicines in . supplying and evaluating the generic drugs. publishing the first list of generic drugs on june ; as of august , product specifications have passed the generic drug consistency evaluation. reforming the drug tendering and procurement system. pilot provinces and pilot cities have implemented the 'two invoice policy' tendering system by the end of ; the drug procurement costs of the corresponding varieties in pilot cities fell from ¥ . billion to ¥ . billion, and the cost dropped by . %. promoting rational use of essential drugs. rates of antibiotic use in inpatient and outpatient care decreased by % in selected tertiary hospitals. increasing investment in the primary healthcare system, including strengthening the infrastructure of phc facilities. government subsidies to phc institutions have increased substantially: from to , subsidies as a proportion of total phc income increased from . % to . %. expanding human resources for primary care through incentives and supporting projects. compared with , the total number of primary healthcare workers in increased by . % to . million, and the number of general practitioners per population increased from . to . . developing a tiered service delivery system by establishing hcas and providing family practitioners contracted services. implementing telemedicine to improve the delivery of services to people living in remote and lowincome areas. more than medical institutions implemented telemedicine services, which have covered all national poverty counties. providing basic public health service package to all people through government subsidies. increased government public funding was invested to expand the services (from categories in to categories in ) and availability of the basic public health package to almost everyone; an average of ¥ was allotted per capita in and was increased to ¥ in . supporting programmes to control the main public health problems. figure illustrates the priorities and relationship among the three healthcare reform plans. main reform initiatives and achievements of the past decade health insurance system reforming the health insurance system is essential and critical since it has served as the major source of financing for the healthcare delivery system. basic health insurance in china, including the urban employee basic medical insurance, the new rural cooperative medical scheme (nrcms) and the urban resident basic medical insurance (urbmi), laid the foundation for universal insurance coverage. priority was given to expanding the scope and health service package of the basic insurance coverage, improving provider payment mechanisms, as well as increasing the financing level, fiscal subsidies and reimbursement rates. to improve equity in access to healthcare between rural and urban areas and efficiency in operation of the schemes, the chinese government consolidated the fragmented health insurance schemes by merging nrcms and urbmi into the urban and rural resident medical insurance in , and then established the national healthcare security administration in to implement unified management for these insurance schemes. in addition, the government launched medical financial assistance in and catastrophic medical insurance in as supplementary medical insurance to provide funds for patients with poverty and catastrophic illness. the moves, parts of 'health poverty alleviation (hpa)' (a critical element of the national poverty alleviation project), are significant steps towards 'healthy china' and uhc, protecting people with low incomes from impoverishment due to exorbitant healthcare costs, and breaking the cycle of poverty and illness. the payment reform is being implemented to modify the behaviour of providers and to control the unreasonable growth of medical expensesreplacing fee-for-service payment with comprehensive payment methods based on disease category. drug supply and security system as the base of drug supply and security system, the national essential medicines system reform is comprehensive and includes but is not limited to the following: the selection, production and distribution of essential medicines; quality assurance; reasonable pricing; tendering and procurement; a zero mark-up policy on sales; rational use and reimbursement; and monitoring and evaluation. the government issued a revision of the national essential medicines list (neml) in including a list of essential medicines, and constantly expands the list to fully meet the needs of basic healthcare. these on-list medicines should be available at all primary care institutions. to improve access to medicines, china boosted the research and development of generic drugs, and required the evaluation of generics to prove they are equivalent to the originator products in terms of quality and efficacy. a 'two invoice policy' tendering system was developed to avoid higher mark-up and reduce circulation during the process of distribution. all medicines in the neml are included in health insurance reimbursement lists, which are reimbursed at higher rates compared with non-essential medicines. medical service system establishing a strong primary care delivery system is an ongoing priority in china. the government has increased bmj global health investment in primary care, with initiatives that include strengthening the infrastructure of primary healthcare (phc) facilities, expanding human resources for primary care through incentives and supporting projects, establishing a general practitioner system and improving the capacity of phc personnel through training and education, such as general practice training and continuous medical education programmes. public hospital reforms focus on removing drug mark-ups as a source of financing, and rationalising medical service pricing (eg, improving the price of medical services that can reflect the value of medical staffs' technical services, and piloting the removal of medical consumable mark-ups). additionally, the priority task is establishing a tiered healthcare delivery system by developing healthcare alliances to improve intersectoral coordination and integration and providing family practitioners contracted services. the development of private hospitals is encouraged to increase the supply of healthcare resources. further, telemedicine is promoted to improve the delivery of services to people living in remote and poverty areas. public health service system the 'equalization of basic public health services' policy implemented the national bphs programme and the crucial public health service (cphs) programme. it aims to reduce major health risk factors, prevent and control major communicable diseases and chronic diseases and improve response to public health emergencies. this policy seeks to achieve universal availability and promote a more equitable provision of basic health services to all urban and rural citizens. the bphs set out the minimum services for all citizens, including health management and monitoring. the service package can be expanded by local governments according to local public health issues and financial affordability. cphs seeks to fight important infectious diseases (eg, prevention and control of tuberculosis, aids and bilharziasis) and meet the needs of vulnerable groups (eg, breast and cervical cancer screening for rural women, cataract surgery for low-income patients). with a focus on public health and prevention, the state council announced a series of recommended actions to achieve 'healthy china ' on july , which include 'intervening in health influencing factors, protecting full-life-cycle health, and preventing and controlling major diseases'. during the past years since the latest round of healthcare reform, china made steady progress in achieving the reform goals and uhc. table showed the summary of the main reform initiatives and achievements. lessons from china's experience achieving uhc is a tough and long-term task that is not unique to china and confronts many other countries. when pursuing uhc, china adopted the general strategies recommended by who, and also developed a pathway with chinese characteristics through healthcare reform. the experience from china may provide invaluable lessons for other countries. first, continued political support is the most important enabling condition for achieving uhc. efforts through national-level initiatives of different governments show that the political will to drive better healthcare is crucial, such as the national health policy in india and rwanda's vision . china's commitment to uhc remains unchanged since the healthcare reform in , and progress through three phases step by step focusing on the overall goal. cpc and governments at all levels have shown clear political willingness to reach the goal by , making uhc achievement a more country-led process. in , president xi jinping announced 'healthy china blueprint', a national long-term strategy in health sector that sets ambitious targets for china. second, increasing health financing is necessary, and the investment from both government and private sectors is considered. at the initial phase of the healthcare reform, on the basis of limited financial fund, chinese government increased investment in healthcare infrastructure and greatly increased the coverage of health insurances, achieving the universal coverage maximally. after years of exploration during the reform process, it was realised that china should strike a proper balance between the government and the market-play the government's leading role in providing basic health services, and at the same time, introduce appropriate competition mechanisms to energise the market in nonbasic health services, encouraging the private sector to provide multilevel and diversified medical services. third, a strong phc system should be regarded as a core component in realising uhc. along with the new declaration of astana, phc for health as a global priority is the pathway to reach the sdgs and uhc. in the early days, some experience in phc in china demonstrated that 'health for all' is a practical possibility, for example, the 'patriotic health campaign' and 'barefoot doctors'. the 'patriotic health campaign' encouraged everyone to participate in public health activities, and aimed to improve sanitation, hygiene, health education, as well as combat infectious diseases. engagement of civil society is necessary to promote uhc. the 'barefoot doctors' model used limited medical resources to provide common disease diagnosis and prevention services to a large rural population. however, the chinese healthcare system created adverse consequences after market-based reforms, in part due to a weakening of support for phc. today, recognising the importance of revamping its phc system, the chinese government has made phc a priority in its 'healthy china ' strategy. in addition to these general lessons, there are also some lessons with chinese characteristics, providing reform experiences for other countries: ( ) china's health reforms are usually piloted and then rolled out nationwide, such as the public hospital reform; or the reform started from the grass level and then refined for the nation, such as the sanming model. ( ) in the latest phase of reform, china is paying more attention to the systemic and linkage reform (ie, tsr). this innovative strategy can help promote the dynamic balance among medical care, medical insurance and medicine, and construct a coordinating healthcare system to achieve uhc. a strength of our study was that we systematically and comprehensively assessed healthcare reform in the past decade moving towards uhc in china, including evolution, initiatives and achievements. the lessons learnt from china could help other nations improve uhc in sustainable and adaptive ways, including continued political support, increased health financing and a strong phc system as basis. the experience of the rapid development of uhc in china can provide a valuable mode for countries (mainly lmics) planning their own path further on in the uhc journey. universal health coverage and public health: a truly sustainable approach the world health report : research for universal health coverage 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containment efforts of a low-resource nation: the first four months in nepal date: - - journal: cureus doi: . /cureus. sha: doc_id: cord_uid: hp yft a novel coronavirus (severe acute respiratory syndrome coronavirus or sars-cov- ) was identified in hospitalized patients in wuhan, china, in december . it rapidly spread across the globe within the span of a few months. nepal is a low-resource country with limited critical care delivery infrastructure. coronavirus (covid- ), the disease caused by the virus, could potentially cause a medical catastrophe in nepal. we reviewed all pertinent documents published in the public domain by the ministry of health and population of nepal and other relevant literature. we aimed to describe the key strategies nepal embraced in the first four months in its attempt to curtail the disease immediately following the identification of its first case and the challenges it faced. in our review, we determined that the key steps taken by nepal included border control to prevent the importation of cases, strict quarantine in facilities for anyone entering the country, early case detection, and isolation of all infected cases irrespective of symptoms. testing capabilities, quarantine facilities, and isolation beds were also rapidly increased. we discuss how nepal achieved some success in the first four months between january , , when the first case was identified, to may , . however, it faced several challenges that ultimately led to an exponential rise in cases thereafter. in december , a novel coronavirus, subsequently termed severe acute respiratory syndrome coronavirus (sars-cov- ), was identified in hospitalized patients in wuhan, china [ ] . coronavirus disease (covid- ) , the disease caused by the virus, was declared a pandemic by the world health organization (who) on march , [ ] . nepal is a small mountainous nation in asia situated between its much larger neighbors, india and china. with % of its million population living below the $ . per person per day international poverty line, and a gross national income of $ per capita, it is one of the poorest countries in the world [ ] . china borders nepal on its north and has extensive sociopolitical relations with the himalayan nation. at the time covid- emerged, there were close to nepali students in wuhan, the epicenter of the disease [ ] . the first case of covid- was a -year-old nepali man, returning from wuhan university of technology, who once the first case was identified, nepal started preparing for the epidemic, focusing mainly on the identification and management of cases [ ] . a high-level coordination committee under the chairmanship of the prime minister and minister of defense was formed for oversight of preparation and response activities. five hub hospitals and satellite hospitals were designated covid- hospitals, requiring dedicated space for the isolation of infected individuals. expert teams were formed to formulate guidelines for the treatment, testing, and management of covid- . ongoing communication was established among the central and provincial health emergency operation centers and the ministry of health. temperature monitoring was instituted at the tribhuvan international airport, the only international airport in nepal. on march , , mandatory self-quarantine of all individuals arriving from the eight nations (china, italy, spain, iran, south korea, germany, france, and japan) that had community spread was initiated. health screening consisting of a questionnaire for symptoms and a temperature check was instituted at points of entry (poe) from neighboring nations, india and china. strategies to prevent the entry of the disease (march , , to march , ) the high-level committee on covid- in kathmandu decided on march to make every attempt to prevent the entry of the virus into nepal [ ] . on march , all entry visas were suspended and all land poe shut down [ ] . passengers that had arrived in nepal were requested to stay in self-quarantine and report to the sukraraj tropical and infectious disease hospital in case of symptoms [ ] . surveillance and containment efforts (march , , to may , ) the second case, a -year-old who had arrived in kathmandu from france, tested positive for sars-cov- on march , . this led to the decision to lock down the nation on march . only essential services, including pharmacies and grocery stores, could open. citizens could only leave their houses at designated time periods [ ] . all domestic and international flights were halted. maintaining physical distancing, masks, hand washing, and hand sanitizers were encouraged. towards the end of march, there were five cases that had arrived from china, europe, and dubai that tested positive and were placed in isolation in covid- -designated hospitals in kathmandu. trained personnel under the epidemiology and disease control division (edcd) were mobilized to conduct extensive contact tracing based on their flight details and movement history to identify individuals with a potential infection. a team was even mobilized to a village outside the capital city to investigate contacts of a case in kathmandu [ ] . terrified villagers enforced lockdown and quarantine, imposing their own rules utilizing ageold "mukhiya" (village chief) traditions, at times even preventing their own relatives working in neighboring towns from entering their villages by barricading entry points [ ] . this state of lockdown continued for almost three months until mid-june. lockdown/quarantine measures were strictly reinforced by the security sector (police, border management, corrections). police presence was expansive and powerful. they implemented cash fines, confiscation of vehicles, and even imprisonment for failure to adhere to quarantine measures. the number of hospitals for the management of covid- was increased to designated hospitals, hub hospitals, and provincial hospitals [ ] . isolation beds were created rapidly in all seven provinces. by may , isolation and quarantine beds were increased to and , , respectively [ ] . an attempt was made to strengthen intensive care units and add additional ventilators. by the end of march, however, there were just icu beds with ventilators nation-wide, and over half were situated within the capital city [ ] . various private and public organizations aided in the training of health care workers and provided them with gowns, gloves, masks, and eye protection. the scarcity of personal protective equipment (ppe), particularly n masks and gowns, has been an ongoing concern. the high-level coordination committee formed a covid- crisis management committee (ccmc) chaired by the deputy prime minister and defense minister to monitor, coordinate, and manage all covid- prevention, control, and treatment activities. furthermore, to make this more effective, district level crisis management centers were also established. the testing capability was scaled up rapidly ( figure ) [ ] . by may , around reverse transcription-polymerase chain reaction (rt-pcr) assays were being done every day. early february, an rt-pcr primer for sars-cov- was made available at the national public health laboratory (nphl) in kathmandu. by may , there were such laboratories providing services around the nation. since these were newly set-up facilities consisting of personnel with limited experience, a nine-member expert team was formed to validate the tests. furthermore, samples of all presumptive cases were cross-verified at nphl before the final diagnosis. a protocol for the establishment of an rt-pcr laboratory was set forth, requiring at least a masters-level microbiologist with some experience in molecular microbiology. even though all flight services were suspended, nepal remained vulnerable to the transport of the virus from its two neighboring nations, china and india. high mountains separate nepal from china on the north, hence, there are limited poe that have remained closed since late january . however, the extensive open border to the south with india is easily accessible through several official and unofficial ground-crossing poe. to prevent the importation of the disease, starting april , "import nirdeshika" (protocol) was initiated at all poe [ ] . accordingly, a certificate of disinfection for transport vehicles, a selfdeclaration form, and a health check of all personnel were required at the health desk. vehicles were kept in the holding yard for disinfection. any suspicion prompted the individuals to be escorted to designated isolation/quarantine centers. mapping of migrant and vulnerable populations was conducted by nepal army and personnel trained and deployed by the edcd. hotspots were determined based on poe into nepal and reported by vigilant citizens, border control, security forces, healthcare workers, and, recently, by mobile tracking. on april , a decision was made to form a three-member case investigation and contact tracing teams (cictts), consisting of a public health professional, laboratory technician/assistant, and paramedic/nurse, utilizing local manpower to expedite and simplify screening and testing. accordingly, in early may, such teams were trained by the edcd and mobilized [ ] . all international travelers into nepal, via air or ground, and those who did not have feasible home-based quarantine facilities or were violating it were kept in quarantine centers for a minimum of days [ , ] . the who advised that all confirmed cases, even mild cases, should be isolated in health facilities, to prevent transmission and provide adequate care [ ] . accordingly, both confirmed and suspect cases were kept under strict isolation in designated covid- hospitals. guidelines were created to monitor quarantine management by the government of nepal. food and daily necessary commodities were provided by the government. by may th, , individuals were in quarantine in facilities around the nation, including schools, tents set up in open fields, other large public buildings and arenas. a rapid diagnostic test (rdt) for serology was initiated in nepal in early april as a supplement to rt-pcr [ ] . by mid-april, all districts throughout nepal were equipped for rdt testing. this gave the opportunity for rapid, on-site tests for surveillance purposes that required minimum skill. wide-spread testing was attempted on individuals entering nepal (figure ). adapted from the government of nepal, ministry of health and population. health sector response to novel coronavirus. [ ] figure demonstrates algorithms for the testing protocol established on april , , for all quarantined individuals and the mechanism for management and discharge once a suspect case was confirmed by rt-pcr [ ] . additionally, since rdt may not show the presence of positive antibodies in early stages and positive cases may be missed, if the cohort tested negative, % of the individuals in the cohort would receive pcr testing for surveillance. positive cases were discharged after two samples of rt-pcr results negative hours apart. figure elaborates the protocol for case investigation and contact identification of probable and suspect individuals, in addition to confirmed cases [ ] . adapted from the ministry of health and population. epidemiology and disease control division. standard operating procedure for case investigation and contact tracing of covid- . interim version. [ ] as of may , , rt-pcr assays and , rdt had been conducted with testing rates of and per , population, respectively [ , ] . on may , in order to increase the rate of testing in the limited number of facilities, pcr of pooled samples of individuals in quarantine and low risk for covid- was started at a ratio of : . social media campaigns, including viber, facebook, websites, in addition to pamphlets, radio, and television focused on educating the public on strategies to prevent transmission [ ] . two toll-free call centers were established in order to provide counseling and information to citizens. a mobile application was set up for individuals to be able to assess their health status. if their self-assessment was concerning, health care workers from the ministry of health contacted them for the further need for testing or management. daily briefings were broadcast by the health ministry via television and radio to share the current state to update the public and debunk false information. after the initial cases introduced into kathmandu by flight in early march as detailed above, there was a cohort of a few dozen indian nationals adjacent to the border entering nepal from india by land that tested positive. early may, there was community transmission, resulting in a handful of sars-cov- positive cases in individuals who were living in nepal. then, the surge in cases in the second week of may occurred as a result of infected nepali migrant workers returning home. males between and years of age consisted of % of confirmed cases. as of may , all but infected cases were asymptomatic or had mild symptoms, with no deaths or even intensive care admissions (figure ) [ ] . the rate of infection in nepal has been increasing exponentially. just in the final three days of the four-month period of this review, confirmed cases doubled from to [ ] . a little over a month later, right before the publication of this article, it has increased to over , with deaths. this exponential increase is as a result of an influx of infected cases crossing the open border between india and nepal as the rate of infection in india escalated [ ] . the economic upheaval caused by the shut-down in india forced thousands of nepali migrant workers to attempt to enter nepal [ ] [ ] . additionally, indian nationals traveled into nepal for religious, social, and trade reasons. there is no requirement for a visa or passport for citizens of these two nations to cross over. most individuals enter nepal via unguarded territories to avoid quarantine thus increasing the risk of community spread of the virus [ ] . this influx has resulted in overwhelmed government-run quarantine and isolation facilities with shared confined spaces. this has, most likely, resulted in the in-facility transmission of the disease. poverty makes home quarantine a poor alternative in a country like nepal where large families live in crowded homes with scarce water and bathroom facilities. ultimately, this can result in unchecked community transmission [ ] . most individuals in quarantine are tested only at the end of two weeks with the serological method before being released to go home [ ] . this increases the period of close contact. inadequate resources and funding compounded by a lack of automated pcr machines limits prompt testing with rt-pcr, which could have led to earlier triage. a major barrier is nepal's dependence on external support and the import of essential health commodities for the covid response, including the diagnostic tools (rt-pcr and serology). at the beginning of the outbreak, nepal also lacked adequate molecular testing facilities and trained manpower except for a few places. inadequate trained manpower and insufficient essential facilities will make it difficult to manage the surge of symptomatic and critical covid- patients. there are medical doctors per , population. two-thirds are working in the few major cities of nepal, including kathmandu [ ] . one recent study reported that medical doctors and nurses were physically present in only % and % of surveyed primary healthcare centers, respectively. furthermore, % of staff consisted of semiskilled and unskilled workers [ ] . additionally, nepal lacks enough hospital beds, intensive care units, ventilators, drugs, and necessary ppes as well as expert manpower such as trained intensivists, respiratory therapists, skilled intensive care unit (icu) nurses, and infectious disease and other sub-specialists [ ] . the country needs to expand its ability for the epidemiological surveillance system and research, both of which are in infantile form at present. not enough field staff and community workers are included or trained in surveillance and contact tracing work. this can lead to difficulty in the identification of cases as the surge continues to escalate. similar to the rest of the world, nepal is seeing more suffering, hunger, disease, and poverty as a result of the lockdown [ ] . a report from john's hopkins bloomberg school of public health projects up to under-five deaths in nepal over just six months due to a reduction in the coverage of essential maternal and child health interventions, including family planning, antenatal and postnatal care, child delivery, vaccinations, food, water, and preventive and curative services [ ] [ ] . almost % of the population in the country, living below the $ . per person per day international poverty line, who are already at risk may be further pushed into extreme poverty as a result of covid- [ ] . nepal is seeing a nationwide increase in suicide rates, by % according to some reports, attributed to the lockdown and poverty [ ] . despite nepal's poverty and lack of infrastructure, an early comprehensive covid- preparedness plan was successful in deflecting the epidemic for the first few months. effective measures included a strictly enforced lockdown, border control to prevent the importation of cases, mandatory institutionalized quarantine for all entering the country, identifying cases by implementing extensive contact tracing, and isolation of all cases irrespective of symptoms. for four months, starting with the first case on january to may , , these measures were very effective at flattening the curve. there were about cases until early may without evidence of community spread, until the further entry of the virus via international travelers. the greatest limitation is the open border with india with thousands of migrant nepali workers returning home. right before this publication, there are almost a hundred-thousand individuals in cramped quarantine facilities, and of the districts are affected. however, most of these cases are being reported from quarantine facilities and community transmission has not been reported in most parts of the country so far. continuing a strict lockdown may not be sustainable for the country anymore except in areas with evidence of community transmission. better provisions for quarantine, ramping up rt-pcr services, increased surveillance, and contact tracing may mitigate some of the issues. additionally, continued behavior interventions, such as social and physical distancing, the use of masks, and hand hygiene, must be encouraged. in compliance with the icmje uniform disclosure form, all authors declare the following: payment/services info: all authors have declared that no financial support was received from any organization for the submitted work. financial relationships: all authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. other relationships: all authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. a novel coronavirus from patients with pneumonia in china world health organization. who coronavirus disease (covid- ) dashboard the world bank in nepal air medical evacuation of nepalese citizen during epidemic of covid- from wuhan to nepal the first novel coronavirus case in nepal covid- nepal: preparedness and response plan (nprp) a survey of adult intensive care units in kathmandu valley hospitals outside kathmandu ill-prepared to fight coronavirus outbreak ministry of health and population. health sector response to novel coronavirus ( -ncov) government of nepal ministry of home affairs, department of immigration mustang locals and village heads impose their own rules to control covid- health ministry releases updated list of hospitals designated for covid- patients in nepal health sector emergency response plan. covid . pandemic rolling updates on coronavirus disease (covid- ) ministry of health and population. epidemiology and disease control division. standard operating procedure for case investigation and contact tracing of covid- nepal's covid- struggle continues amid a concerning surge ministry of home affairs. nepal covid- dashboard asymptomatic patients to be quarantined or sent home as ministry expects , cases in a week human resources for health (hrh) and challenges in nepal distribution and skill mix of health workforce in nepal the asia foundation. nepal. coronavirus dispatches early estimates of the indirect effects of the covid- pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study the world bank in nepal. recent economic developments suicide cases on the rise, mental health experts warn of a 'grim situation the authors would like to thank saugat shrestha for reviewing the manuscript. key: cord- -cjxuvyh authors: sylvestre, emmanuelle; thuny, rené-michel; cecilia-joseph, elsa; gueye, papa; chabartier, cyrille; brouste, yannick; mehdaoui, hossein; najioullah, fatiha; pierre-françois, sandrine; abel, sylvie; cabié, andré; dramé, moustapha title: health informatics support for outbreak management: how to respond without an electronic health record? date: - - journal: j am med inform assoc doi: . /jamia/ocaa sha: doc_id: cord_uid: cjxuvyh nan to the editor, the world is facing an unprecedented health crisis in with the covid- pandemic. reeves et al. paper [ ] underlined the importance of the electronic health record (ehr) and health informatics in general to support outbreak management. they proposed several recommendations heavily-based on the ehr to help hospitals improve their response in this unique situation. this article is extremely relevant for the united states, since most american within the healthcare system have their data recorded electronically. according to the office of the national coordinator for health information technology (onc) report, as of , % of non-federal acute care hospitals and % of office-based physicians had adopted certified health information technology (it). [ ] thus, with a fully functioning ehr, the authors were able to implement screening tools to help proper triage, ordering tools for accelerated biology and imaging exams and even clinical decision support. all of those ehr enhancements followed covid- monitoring guidelines set by institutions and were a major help for outbreak management. the use of ehr as a potential public health tool has been studied for years [ ] and with the covid- pandemic, many institutions worldwide have tried to leverage its full potential to accelerate their response. however, some health institutions are still struggling to entirely digitize their health data. in iii) be able to create and distribute real-time reports. we managed to build two databases in less than a week. the first database (covid-samu) is a triage database used for monitoring outpatient cases, with a phone call schedule based on national monitoring guidelines. the database has information on all outpatient cases, including their address, their age, their underlying diseases and their different symptoms. sociodemographic data from patients with covid-like symptoms are first automatically integrated from the hospital triage software. then, we developed a web application where each clinician can fill specific forms to monitor covid symptoms and their evolution at the time of each phone call. we decided to heavily rely on this form of outpatient monitoring rather than self-reporting (for example, based on a smartphone application) because of our population characteristics (martinique is one of the oldest french territory). the second database (covchum) is for hospitalized patients. this database also integrates the few digitized data available (administrative data, reimbursement claims and laboratory test reports). as for the covid-samu database, we developed a web-application and covidspecific forms for clinicians. in this case, we needed to be able to integrate quickly the most important data for covid monitoring despite the lack of interoperability between our different digitized systems. since our administrative data is fully digitized, we were able to link patients throughout the both databases are implemented with windev ® , because it allowed us to automatically integrate data from our hospital framework (all of our hospital software rely on oracle ® database management system). we also used webdev ® to develop the web-based applications, because we wanted to be able to deploy them hospital-wide in a very short time, even with a very small team. finally, both covid databases allow to perform queries using structured query language (sql) and extract structured data in comma-separated values (csv) form, which helps us create real-time reports. we still wanted to comply as much as possible with health it guidelines. as a result, we focused on interoperability, standardized terminologies and automatic data collection when possible. we also implemented simple rule-based natural language processing algorithms to be able to extract unstructured data from clinical notes. despite our limited resources and our lack of an existing adequate informatics framework, we managed to implement relatively simple tools, which helped us improve our ability to rapidly respond to the evolving situation. the electronic health record is an essential tool for covid- management, but even without it, we can still develop alternative solutions that can tremendously help hospitals with limited resources and without state of the-art health it. we should leverage these solutions to help reduce the impact of the digital divide in healthcare, especially in time of crisis. report to congress -annual update on the adoption of a nationwide system for the electronic use and exchange of health information global preparedness against covid- : we must leverage the power of digital health the authors have no competing interests to declare. this research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. key: cord- -tq tbhsn authors: hensel, d. j.; rosenberg, m.; luetke, m.; fu, t.-c.; herbenick, d. title: changes in solo and partnered sexual behaviors during the covid- pandemic: findings from a u.s. probability survey date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: tq tbhsn background: research demonstrates that pandemics adversely impact sexual and reproductive health (srh), but few have examined their impact on participation in sex. we examined self-reported changes in solo and sexual behaviors in u.s. adults during early stages of the public health response to covid- . methods: we conducted an online, nationally representative, cross-sectional survey of u.s. adults (n= ; aged - years; % response rate) from april - , . we used weighted multinomial logistic regression to examine past month self-reported changes (decreased, stable or increased) in ten solo and partnered sexual behaviors. predictor variables included: having children at home, past month depressive symptoms, (acha -item scale), past month loneliness (ucla -item loneliness scale), covid- protection behaviors (adapted -item scale), perceived covid- consequences (adapted -item scale) and covid- knowledge (adapted -item scale). findings: nearly half of all adults reported some kind of change, most commonly, a decrease, in their sexual behavior in the past month. having elementary aged children at home, past month depressive symptoms and loneliness and enacting more covid- protective behaviors were associated with both reduced partnered bonding behaviors, such as hugging, cuddling, holding hands and kissing, as well as reduced partnered sexual behaviors, such as oral sex, partnered genital touching and vaginal sex. greater covid risk perception and greater covid knowledge were associated with mixed effects in behavior outcomes. interpretations: our data illustrate the very personal ways in which different pandemic-associated factors may create or inhibit opportunities for solo and partnered sex. the centrality of sexuality to health and well-being, even during pandemics, means that a critical piece of public health prevention and management responses should is ensuring that services and resource that support positive sexual decision making remain open and available. in march , the world health organization (who) classified the novel coronavirus (sars-cov- ), and the illness it causes (covid- ) , as a pandemic. past research demonstrates that pandemics (e.g., mers, sars, ebola, zika) adversely impact sexual and reproductive health (srh), by reducing access to srh-related supplies (e.g. contraception/condoms) or services (e.g. abortion, health care), by increasing exposure to sexual and/or physical violence, and by increasing economic insecurity. few studies have examined how pandemics, including covid- , impact solo and partnered sexual behaviors. experiences could influence desire and ability to participate in sex, the types of sex they choose, and the extent to which behaviors differ from non-pandemic times. understanding how and why changes occur is necessary to continue to adapt public health covid- management in ways that are consistent with people's fundamental rights to sexual health and well-being. , covid- transmission could influence how people approach sex. for example, covid- can spread through aerosolized respiratory particles (e.g. coughs, sneezes, speaking). while preliminary data seem to indicate that the virus is detectable in some (e.g. semen and feces) but not all (e.g. vaginal fluid and urine) of the bodily fluids associated with sexual activities, more research is needed to understand sexual transmission risk. an infected person could transmit sars-cov- to a partner via airborne respiratory secretions or from their skin during close contact (e.g. kissing, genital touching), oral sex, vaginal sex, and/or sharing sex toys. , engaging in sexual behaviors that avoid close contact, like watching sexually explicit videos, sending sexual text messages, or phone/video sex, could reduce risk. what an individual knows about covid- and how susceptible they feel to infection may also influence their sexual behavior. individuals may avoid partnered, close contact sexual behaviors if they believe that getting covid- may result in serious medical consequences for them or that the virus is difficult to treat. individuals who are well-educated about covid- , including transmission and prevention information, may feel empowered to participate in partnered sex particularly if they perceive that knowledge makes them "low risk." finally, covid- mitigation measures, such as social distancing and recommended hygiene (e.g., hand washing), could impact how people approach sex. many states and communities implemented "stay at home" orders that limit or prohibit activity in local non-essential businesses (e.g. shops, bars) and leisure areas (e.g. playgrounds) and have closed educational institutions (e.g. primary school and/or universities). such policies have been associated with reduced sexual activity in men who have sex with men and chinese adults. moreover, teleworking, caring for children without childcare, school, or playdates/sleepovers, and helping school aged children engage in school online may impact both the time and space that people have available for sex. social distancing may also exacerbate depression and loneliness, further decreasing desire for and frequency of sex. meanwhile, social distancing or partner separation could increase solo masturbation or adjust partnered activities toward technology-mediated sexual interactions (e.g., using text messaging or video chat). , , the purpose of the current paper is to characterize the past month self-reported sexual changes in solo and partnered sexual behaviors in a nationally representative sample of u.s. adults, and understand how those changes are associated with structural, mental health, and covid-associated risk perception and knowledge. data were the national survey of sexual and reproductive health during covid- (nsrhdc), a cross-sectional, online, nationally representative survey of covid- related attitudes, experiences and knowledge among u.s. adults aged - years. the study was conducted in april by ipsos research using their knowledgepanel® (menlo park, california) to recruit a probability-based web panel designed to be representative of noninstitutionalized u.s. citizens. ipsos creates research panels using an address-based sampling (abs) frame from using the u.s. postal service's delivery sequence file -a database with full coverage of all delivery points in the u.s. abs not only improves population coverage, but also provides a more effective means for recruiting hard-to-reach individuals, such as young adults, . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint those without landline telephones and racial/ethnic minorities. panel member households without internet connection are provided with a web-enabled device and free internet service to maximize the breadth of participation. the -item online survey took a median of minutes (mode of minutes) to complete, was available in english and spanish languages, and was open for participation from april - , . individuals randomly selected to participate were notified of the survey's availability via email and through their online member page. electronic notification allows surveys to be fielded more quickly and at less cost, and it also reduces the burden on participants, because they receive information in a more private fashion, and can take the survey at a time, and in a location that is convenient for them. knowledgepanel® members typically only receive up to one survey per week, with an average of two to three per month. reminder emails were sent to survey non-responders on the third day of the field period. of the original individuals recruited (n= ), ( %) completed the survey and represent the analytical sample in this study. ipsos operates a modest incentive program that offers points for survey completion; points can be accumulated and exchanged for cash or merchandise. ipsos provided post-stratification, study-specific weights to adjust for any over-or under-sampling as well as nonresponse. geodemographic distributions for the corresponding population were obtained from the cps, the u.s. census bureau's american community survey (acs), or from the weighted knowledgepanel profile data. for this purpose, an iterative proportional fitting procedure was used to produce the final weights. in the final step, calculated weights were examined to identify and, if necessary, trim outliers at the extreme upper and lower tails of the weight distribution. the resulting weights were then scaled to aggregate to the total sample size of all eligible respondents. participant characteristics are included in table . ipsos provided post-stratification, study-specific weights to adjust estimates for any over-or undersampling as well as nonresponse. study procedures were approved by the indiana university institutional review board (# ). . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted june , . we also included two mental health variables. past month depressive symptoms included a subset of five items ("felt overwhelming anxiety," "felt very sad," "felt that things were hopeless," "felt so depressed that it was difficult to function" and "felt very lonely"; all ("no, never," "yes, but more than a month ago," and "yes, in the past month") adapted from the american college health association. we created for analysis a dichotomous measure to indicate an answer of "yes, in the past month" for one or more of the five items. loneliness was examined using three items ("how often do you feel that you lack companionship," "how often do you feel left out" and "how often do you feel isolated from others?" from the ucla loneliness scale short form. we recoded each of the four original categories ("not at all" [ ], "hardly ever" [ ], "some of the time" [ ] and "often" [ ] ) and summed all items. finally, we created a dichotomous measure for analysis (not lonely [ - ] vs. lonely [ ] ). . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint we also included three covid- context variables. covid- past month protection behaviors was an index of , -point (not at all true of me, a little true of me, somewhat true of me, very true of me) behaviors ("i stayed at home," "i did not physical attend social gatherings," "i kept a distance of at least two meters ( feet) from other people," "if i had exhibited symptoms of sickness, i would have immediately informed the people around me," "i washed my hands more frequently than the month before" and "i canceled out of state or international travel plans," "i made sure i have enough prescription and over the counter medicines to meet my current health needs," "i made sure i have enough condoms at home to meet my disease prevention and/or pregnancy prevention needs," "i made sure i have enough birth control at home to meet my pregnancy prevention needs," and "i made sure i had enough products to meet my hygiene needs [e.g. menstruation supplies, incontinence supplies, etc."). the first six items were modified from covid- research and the last six were designed by the second and last authors for this study. perceived next month likelihood of covid- consequences was an additive index of ten, four point (high chance (> %), medium chance ( - %), low chance (< %), no chance, has already happened [dropped from analysis]) potential medical and social events ("being exposed," "getting an infection," "being hospitalized," "knowing someone personally with an infection," "knowing someone personally who has died of an infection," "losing your job," "partner/spouse losing their job," "not having enough to eat," "parent(s) losing their job," "missing important healthcare appointments or treatment"). these were original items designed by the authors for this study. knowledge was an adapted , ten-item scale designed to assess understanding of virus properties, transmission, and symptomology. a higher score indicates a greater depth of knowledge. control variables. we included several control variables, including gender, race/ethnicity, sexual orientation (heterosexual/sexual minority), age, living with partner (no/yes), employment status (working as an essential worker, working as non-essential worker, not working). . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint mixed effects multinomial logistic regression (stata, v. ) evaluated the impact of age of predictor variables on likelihood of reported change in each sexual behavior, controlling for the influence of confounding variables. in each model, we estimated the adjusted odds ratio (aor) and corresponding % confidence interval (ci) for each predictor variable's influence on an outcome behavior's likelihood categories relative to the others. a random intercept approach allowed our estimates to vary across individuals, and adjusted estimates for clustering within states. we weighted all analyses to account for nonresponse and to adjust estimates to the demographic distribution in the united states. we evaluated each sexual behavior outcome twice -once using "stable" as the referent, and then using "decrease" as the referent (tables and ) . the weighted sample was . % female, . % ethnic/racial minority ( . % non-hispanic black, . % hispanic, . % other or multiple races) with a mean age of . years (sd= . years; range: - years). most were heterosexual ( . %) and married and/or cohabitating ( . %). about a third were employed as either an essential worker ( . %). the mean household size was about two people (sd= . ) ( table ) . overall, across all ten behaviors (tables and ) , nearly half ( . %) of the sample reported some kind of change -most commonly, a decrease -in their sexual behavior in the past month. the most common behavior (table ) to increase were hugging, kissing, cuddling or holding hands with a partner . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . ( . % ) and the least common increase was vibrator or sex toy use during solo masturbation ( . %). the most common behavior (table ) to decrease was hugging, kissing, cuddling or holding hands with a partner ( . %) and the least common decrease was sending or receiving sexy or nude pictures from a partner ( . %). over half of participants ( . %) reported stability in hugging, kissing, cuddling or holding hands with a partner. most reported stability in sending or receiving sexy or nude pictures from a partner ( . %), vibrator or sex toy use during solo masturbation ( . %), having phone or video chat sex with a partner ( . %) and vibrator or sex toy during partnered masturbation ( . %) we evaluated all outcomes (tables and ) using both "no change" and "decreased" in turn as referent categories. significant results from all models are reported below. participants with any children under age five in the house were three times more likely to report increased (vs. decreased: aor= . ) hugging, kissing, cuddling or holding hands with a partner in the past month, and were less likely to report a decrease ( . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . enacting more protective behaviors was linked to decreased (vs. stable) in hugging, kissing, cuddling or holding hands with a partner, solo masturbation partnered masturbation/genital touching, vaginal sex and watching porn/erotica with a partner in the past month (all aor= . - . ). finally, greater covid- knowledge was associated with lower likelihood of increased (vs. stable) solo masturbation, partnered masturbation/genital touching, receiving oral sex, vaginal sex and phone/video . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . sex/chat with a partner in the past month (aor= . - . for all outcomes). participants with greater covid- knowledge were less likely to report they had experienced decreased (vs stable) giving/receiving oral sex, sending/receiving sexy or nude photos with a partner, watching porn/erotica with a partner and phone/video sex/chat with a partner in the past month (aor= . - . for all outcomes). past research demonstrates that pandemics (e.g., mers, sars, ebola, zika) adversely impact sexual and reproductive health (srh), yet limited scientific evidence -including from the covid- pandemic -examines their influence on how people organize their sexual lives. our work is one of the first studies to address this literature gap, using a u.s. nationally representative, probability survey of adults to assess self-reported changes in solo and partnered sexual behaviors relatively early in the covid- pandemic. half of all adults in the united states reported that they had experienced change -most commonly, a decrease -in their past month sexual behavior (a time when most of the country was subject to stay at home guidance). our data illustrate the very personal ways in which different pandemic-associated factors may create or inhibit opportunities for solo and partnered sex. we found that having any children under the age of five at home was associated with greater likelihood of stability and/or increase in several partnered behaviors, while having elementary aged children was often linked to decreased reports of these behaviors. these findings are largely consistent with differences in how "stay at home" orders may have asked parents to balance working from home and childcare in an absence of school, day care, or other forms of childcare outside the home. parents of smaller children may be better able to maintain pre-pandemic schedules and routines (e.g. naptimes and/or earlier bedtimes) that free some consistent time for partnered sex in ways that may be more challenging for parents of older school-aged children to do. parents of young children may also report increased hugging, kissing, cuddling or holding hands because it is a part of group/family . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint interactions (e.g., family cuddling, snuggling, or hugging) which may increase oxytocin and decrease cortisol, at least for mothers. further, although we did not measure perceived domestic stress, it could also be that integrating multiple roles (e.g. parent, educator, etc.) may create stress that lowers desire either for sex or for extended time with one's partner. , then again, people engage in solo and partnered sex for varied reasons including due to boredom and to relieve stress, and partnered sex is well-documented to enhance love, pleasure, and nurturance. [ ] [ ] [ ] global research has raised concerns that social distancing measures, though necessary to control covid- , can exacerbate feelings of depression and loneliness for some people. we add to this body of research by showing that past month depressive symptoms and loneliness were associated with both reduced partnered bonding behaviors, such as hugging, cuddling, holding hands and kissing, as well as reduced partnered sexual behaviors, such as oral sex, partnered genital touching and vaginal sex. somewhat consistent with existing research, , we found that people who perceived greater personal risk for covid- medical or (e.g., they or a loved one getting sick) or social consequences (e.g. job loss or missing medical appointments) reported a decrease in some, but not all, solo and partnered sexual behaviors. subsequent research might assess whether how specific sexual transmission concerns, as well as more global pandemic-associated stress, impact people's sexual choices. finally, our research shows that people with greater covid- knowledge were more likely to report stability in partnered sexual behaviors. we could not assess whether greater knowledge increased people's comfort to maintain existing habits, or whether greater knowledge was a barrier to more sex. future studies that assess the link between coronavirus knowledge and subsequent sexual behaviors would benefit from including scale items that specifically address sex as a transmission route. our data answer a call for research that more explicitly integrates sexuality and sexual behavior within the pandemic literature, but more research is needed in order to better understand the short-and . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint long-term effects of the pandemic experience on human sexual health and well-being. a research agenda that maintains a focus on sexual well-being during pandemics supports existing public health prevention goals, as well as global perspectives on sexual and reproductive health rights. from a public health perspective, sexual-health-as-prevention paradigms recognizes that an individual's circumstances impact their decisions about how and when to have sex. - key resources like access to health care and services, access to condoms/contraception, and access to medications for sexual health, scaffold people's ability to control when they want to have sex, make sex more enjoyable, and reduce and/or avoid risk behaviors when sex occurs. pandemics cause well-documented interruptions to all of these resources, increasing people's downstream exposure to adverse outcomes like sexual violence, unintended pregnancy and sexually transmitted infections, as well as the mental and sexual health consequences of unwanted abstinence. these effects may particularly be magnified in sexual and/or racial minority populations. as part of pandemic preparation, communities should ensure that sexual health care facilities remain open, all sexual and reproductive health care services remain "essential" and that supply chains of key supplies remain as open as possible. from a global sexual and reproductive health rights perspective, many international health organizations have increasingly endorsed both the idea that sexuality is a central element in life long health and well-being , and that access to experiences that promote positive sexuality -including sexual behavior -are a human right. in the context of pandemics, this perspective affirms the role that evidencebased research plays in helping clinicians and health educators understand the importance of sexuality and sexual experience during times of public crisis, assess individual barriers to desired sexual experiences, and devise solutions to sexual challenges that are appropriately tailored within a person's circumstances. the near complete lack of sexual behavior research amidst the explosion of other covid- health outcomes research may inadvertently lead health professionals and lay people alike to falsely conclude that individuals should universally refrain from sex with non-household partners until the pandemic ends. messaging that encourages sexual abstinence or that stigmatizes sexual desire is unlikely to reduce sex, and in fact may compound people's existing pandemic-associated mental health challenges and/or prevent . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . them from seeking risk reduction advice from their health care provider. our research, as well as future pandemic sexual health research, could help prepare clinicians and educators to ask their clients and patients about their plans for sexual activity and to counsel them in ways supportive of their sexual health. our research had several limitations. first, we did not assess the infection status of participants, their sexual partner(s), or household members. we also did not measure whether or not a participant or anyone around them had exhibited covid- symptoms in the past month. future studies could explore the impact of infection status and duration, as well as symptom experiences, on sexual decision-making. second, due to space limitations and relative population-level infrequency of anal behaviors, we did not ask about any changes anal sex activities. the potential of feces as a virus transmission route warrants further investigation of these behaviors. third, we did not ask participants about their formal inclusion in a stay-at-home/shelter-in-place order and/or the extent to which they were following such an order, though we do know that most of the country was subjected to such in the month prior to the study period. this information could have implications for the structure of time available for sex, particularly in the context of other obligations like work or childcare. finally, this survey assessed sexual behavior changes relatively early in the epidemic. we do not know how measures taken to manage covid- could change behavioral practices in ways that could increase or reduce odds to adverse sexual outcomes. as the covid- continues, emerging srh focused research should continue to focus on the pandemic's impacts on people's sexuality. information about types and frequency of sexual behavior are key to both aiding public health officials to disseminate accurate information and to, as well as to helping medical and sexual health education professionals proactively counsel their patients/clients. more data help achieve full understanding of transmission of the sarscov- virus through intimate contact, as well as to understand the short-and long-term influence of the covid- pandemic on sexual health and well-being. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . less than high school ( . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . covariates are gender, race/ethnicity, sexual orientation, age, living with partner and work status *p<. ; **p<. ; ***p<. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . world health organization. who director-general's opening remarks at the media briefing on covid- - centring sexual and reproductive health and justice in the global covid- response the impacts of isolation measures against sars-cov- infection on sexual health covid- : what implications for sexual and reproductive health and rights globally? sexual and reproductive health matters sexual and reproductive health (srh): a key issue in the emergency response to the coronavirus disease (covid- ) outbreak. reproductive health sexual health in the sars-cov- era sex and coronavirus disease (covid- ) an outbreak of the severe acute respiratory syndrome: predictors of health behaviors and effect of community prevention measures in hong kong anticipated and current preventive behaviors in response to an anticipated human-to-human h n epidemic in the hong kong chinese general population characterizing the impact of covid- on men who have sex with men across the united states in changes in sexual behaviors of young women and men during the coronavirus disease outbreak: a convenience sample from the epidemic area us public concerns about the covid- pandemic from results of a survey given via social media mental health and psychosocial problems of medical health workers during the covid- epidemic in china a population study of the association between sexual function, sexual satisfaction and depressive symptoms in men american sexual health association. sex in the time of covid- american college health association. national collehe health assessment a short scale for measuring loneliness in large surveys: results from two population-based studies global behaviors and perceptions at the onset of the covid- pandemic knowledge, attitudes, and practices towards covid- among chinese residents during the rapid rise period of the covid- outbreak: a quick online cross-sectional survey knowledge and perceptions of covid- among the general public in the united states and the united kingdom: a cross-sectional online survey. annals of internal medicine oxytocin, cortisol, and triadic family interactions maternal health considerations during disaster relief individual differences in the experience of sexual motivation: theory and measurement of dispositional sexual motives why humans have sex centers for disease control and prevention. a public health approach for advancing sexual health in the united states: rationale and options for implementation, meeting report of an external consultation a national strategy to improve sexual health adolescent sexual health and sexually transmitted infections: a conceptual and empirical demonstration defining sexual health: report of a technical consultation on sexual health pan american health organization. life skills apporach to child and adolesent healthy human development understanding sexual health and its role in more effective prevention programs abstinence-only-until-marriage: an updated review of us policies and programs and their impact lifespan sexuality through a sexual health perspective achieve recognition of sexual pleasure as a component of well-being defining sexual and reproductive health and rights for all an event-level analysis of the sexual characteristics and composition among adults ages to : results from a national probability sample in the united states key: cord- -nl rhvlu authors: turner, cameron; bishay, hany; peng, bo; merifield, aaron title: the alpha project: an architecture for leveraging public health applications date: - - journal: int j med inform doi: . /j.ijmedinf. . . sha: doc_id: cord_uid: nl rhvlu objective: public health surveillance applications are central to the collection, analysis and dissemination of disease and health information. as these applications evolve and mature, it is evident that many of these applications must address similar requirements, such as policies, security and flexibility. it is important a software architecture is created to meet these requirements. methods: we outline the requirements for a public health surveillance application, and define a set of common components to address these requirements. these components are configured to produce services used in the development of public health applications. results: a layered software architecture, the alpha architecture, has been developed to support the development of public health applications. the architecture has been used to build eleven surveillance applications for the public health agency of canada in the areas of disease surveillance, survey, distributed data collection and inventory management. conclusions: we have found that a software architecture that addresses requirements on policies, security and flexibility facilitates the development of configurable public health applications. by creating this architecture, key success factors, such as reducing cost and time-to-market of applications, adapting to changing surveillance targets and increasing user efficiency are achieved. public health surveillance is the ongoing, systematic collection, analysis, interpretation and dissemination of data regarding a health-related event for use in public health action to reduce morbidity and mortality and to improve health [ ] . a public health surveillance application is a software system designed to assist in these activities. the ability to accurately monitor and track emerging and previously identified infectious diseases, such as severe acute respiratory syndrome (sars), avian flu, bovine spongiform encephalopathy (bse) and hiv/aids, is key to preventing outbreaks and epidemics. in the shrinking global village, an outbreak can quickly become a public health problem, so or no analysis and use of the corresponding information [ ] . there are many public health surveillance systems in operation. a review of current surveillance systems reveals that there are over detection systems in use in the u.s. and elsewhere [ ] . at the public health agency of canada (phac), there are different surveillance system applications in production, ranging from surveillance databases, survey applications, inventory and laboratory systems. many of these phac applications are customized to be disease-specific, or are developed for a particular surveillance function (e.g., subject identification encryption). furthermore, many of these phac applications are developed using different technologies. maintaining these heterogeneous systems are fiscally and resource expensive. rapidly changing environments require the delivery of timely surveillance information [ , ] . in response, the alpha project is an initiative that started in late . the purpose of the alpha project is to develop a software application architecture based on the philosophy of configuring and reusing common components to produce services that would be used to enable faster development of robust, maintainable public health applications. public health is practiced through complex relationships of organizations (e.g., local, federal) and functionally organized units (e.g., health departments, disease programs) [ ] . as such, the emphasis of the project is not on creating one monolithic application to handle all public health surveillance needs, but rather on creating customizable applications with the same underlying architectural or component structure. the goal is to reduce the amount of new development work required for each new application, in order to reduce its time-to-market. configuration plays an increasingly larger role in the development cycle, and leads to more flexible applications responsive to new and emerging public health needs. new components or services that have to be built are designed in such a way that other applications can use them, and contribute to the architecture. consequently, software becomes more maintainable, since applications share many of the same components. this paper defines a software architecture that is used to build public health surveillance applications. it focuses on common components, which are configured to provide different services that are integrated into each application. this paper is outlined as follows. in section , we summarize the requirements identified for a public health surveillance application. in section , the alpha architecture is described which meets these requirements. in section , three applications, which have been built using the alpha architecture, are explained. section provides a description of how the data collected within these applications is analyzed. related work is outlined in section while sections and summarize the paper. at the public health agency of canada, many different surveillance system applications have been developed using different technologies to collect data for specific diseases. by studying these applications, the following important, common requirements have been extracted: • flexibility: tracking and monitoring diseases is a dynamic activity. emerging diseases, such as sars can appear very quickly, requiring public health officials and surveillance applications to respond just as quickly [ ] . when a disease outbreak occurs, it is essential that the technology tools be in place to track cases and contact information. public health officials do not have the luxury of time to develop systems in response to each disease outbreak. an application must be flexible to handle new diseases [ ] . in addition, given the possible links between outbreak events, epidemiologists analyzing data collected by a surveillance system may need to gather different data as they discover new information. a surveillance application must be able to adapt to these changing data and analysis requirements. • maintainability: applications are inherently expensive to maintain. the cost of supporting a deployed software product can be between and % of its lifetime cost [ , ] . the greater the degree of heterogeneity that exists in the application suite available for an organization, the more expensive it is to maintain. for example, different applications tend to use different technologies and different versions of third party software. keeping track of all the applications' technology version matrices can be complex, and the licensing costs can be expensive. making viable the sharing of common architectural components among applications reduces support complexity and licensing costs. • jurisdictional configurability: each jurisdiction collecting public health surveillance data has its own policies or business rules governing the content and format of data to be collected. for instance, larger jurisdictions may be able to collect last names of their subjects, while smaller jurisdictions may only be allowed to collect their initials. similarly, some jurisdictions may want to include the complete date when collecting a birth date, while others can only record the month and the year. an application distributed to different jurisdictions must be able to handle these variations in policy. furthermore, since policies can change within jurisdictions, established or already implemented applications must be readily configurable. • alert notifications: a core requirement of a surveillance application is to send alert notifications to designated people indicating that a certain event has occurred. an event could be the occurrence of two or more cases of a similar disease being reported in potentially multiple jurisdictions within a certain time frame (i.e., outbreak). another event may raise attention to data anomalies within a case that requires attention. an event could even be a user accessing an application after hours. events such as these help users to manage their applications and understand the data being stored. alerts could take the form of an email notification, a message sent to a personal digital assistant (pda)/cell phone, or a posting to a web site. • security: due to the sensitive nature of public health surveillance data, security is of the utmost concern. one area of concern within security is authorization. particular individual users of applications may only see a subset of the data, and only certain functions of the application depending upon their role. for instance, if an application collects data from different jurisdictions, a public health official in one jurisdiction should not be able to see data collected in another jurisdiction. furthermore, access to different parts of the application should be restricted only to those who are authorized. auditing functions can also assist in monitoring what applications and which data are being accessed by a specific user. • usability: prior to the analysis and reporting of public health information, data must exist in a repository. currently, data collection poses the single most resource intensive component of surveillance cost, since data must be manually entered into a repository. a disease case can require the collection of, potentially, a few hundred data elements. based on our experiences, data entry clerks often complain of user interfaces being crowded with irrelevant data fields since not all data elements need to be collected for a case. to reduce this overhead associated with data collection, the presentation of a surveillance application interface must optimize data entry and filter out irrelevant data. • data sharing: public health surveillance applications collect data about different diseases from different demographics. this data is usually stored in different databases. valuable information could be discovered if field entries from these databases were cross-referenced, and in line with existing legislation and privacy controls stored in a central database. the pan-canadian electronic health record project by canada health infoway is a multi-year initiative focussed on integrating canadian surveillance systems from a data perspective [ ] . to support this important objective, a surveillance application must have the capability of sharing data with other applications. • statistical analysis and reporting tools: once data has been collected and entered into the system, epidemiologists and other public health professionals must be able to analyze the data and report on its contents. a number of commercial off-the-shelf (cots) statistical analysis and reporting tools adequately support this requirement. thus, phac has elected to integrate cots products into the surveillance environment to support this need. this section describes the alpha software architecture proposed to address the requirements previously identified. we have found that as different applications evolve and mature, a pattern of solutions has been discovered within the software that can be abstracted and reused to address these requirements. this bottom-up approach forms the core of the architecture's components. these components can be instantiated with concrete data and other code to produce a usable service. applications then use these services to provide the necessary functionality. fig. shows the alpha architecture. the component layer contains the building blocks that provide the framework for producing application functionality, but not the content. therefore, a component is not entirely usable on its own-it must be given a specific implementation. for instance, a profiler component provides an access control framework. the component, itself, is not concerned with the specifics as to what it is controlling access. the same is true with the business rules component. this component only provides the framework, language and inference engine to enable rules-based logic. it does not provide any actual rules. it is through the use of these common components that the maintainability requirement is addressed; these components form the core of the underlying structure of each application. the service layer provides a set of common services for use in the application and configuration layers. these services encapsulate a specific set of functions, which can be easily integrated into an application. these services are also used between themselves. for instance, a disease access service uses the profiler component to provide the access control functionality specifically for case information on different diseases. for this service, an instantiation of the profiler component with the addition of disease-specific data creates a service. the configuration layer provides a set of common tools that can be combined with applications in the application layer to deliver a fully functioning application suite. these tools handle certain configurations of the system. for instance, the business rules manager facilitates the creation, modification and deletion of business rules and policies. the access manager permits the configuration of the authorization privileges for organizations, regions and users. finally, the application manager allows for viewing and configuring logs and audits. these tools require very little modification to be adapted to be used in different applications. the application layer consists of the different applications comprising the entire system. applications, such as infectious disease surveillance system (idss), anti-microbial resistance surveillance system (amrss) and enhanced surveillance of canadian street youth (escsy) exist at this layer. these three examples are presented later. this section outlines the building blocks of the component layer, which provides the core of the architecture. public health is practiced through complex relationships of organizations (e.g., local, federal) and functionally organized units (e.g., health departments, disease programs) [ ] . as a direct consequence, public health applications must be flexible, secure and able to handle differences between jurisdictions. the profiler component is designed to meet these requirements. the profiler is a generic component customized to manage the authorization of an entity across different organizations. an entity is defined as anything that should be restricted at some level (e.g., a disease data element or an application function). the configuration of accessibility to these entities creates a profile. profiles are handled through the access manager in the configuration layer, and this tool is used to assign multiple profiles to a user. we model a profile using a hierarchical data model where the entity structure is based on categories, properties and attributes, and the organizations are based on groups and units within the organization. in our model, a category can have n properties. each of these properties can have n attributes. for instance, a disease (category) can have multiple sections to its data entry forms (properties) that, in turn, can have multiple data elements (attributes). similarly, an organization can have n regions (groups). each of these groups can have n districts (units), and each district can contain many users. fig. shows the data model for a profile. as an example, this data model provides an authorization service for diseases, and so it is possible to control access for every data element for each user. this addresses the security requirement as it prevents a user in one district from viewing or modifying public health data in another district. furthermore, we can also use this data model to provide an authorization service for application functions. access can be easily configured to accommodate some users in the same district from accessing certain functions within an application, while allowing another user in the same district to have full access. since the profiler component is a framework that is customized using data, new entities such as emerging diseases can be added or modified easily by inserting data specific to the new requirement, thus addressing the flexibility requirement. an application that can be adapted to handle the addition of emerging diseases solves one of the problems that hindered the fight against sars [ , ] . finally, the profiler component provides the ability to handle differences between jurisdictions. some jurisdictions may want to collect surveillance data that others may not need. the non-required data elements are then 'switched off', so they do not appear in the application. as a result, data collection is streamlined and application navigation is optimized at no additional cost to the development process. software systems are typically comprised of disparate applications, each executing in different process spaces. these applications can reside entirely on one machine, or be distributed over several machines. one of the requirements identified in the previous section outlines that there are times when applications need to share information. for this reason, a communications component is required to handle inter-application communication. the message server is designed to meet this requirement. messages are transmitted between applications over a secure http link using the simple object access protocol (soap). these messages are modeled using xml. we use a service locator to identify whether the service to be invoked should be done locally or remotely. for instance, a service to retrieve a patient's current active cases may be done within an application itself (i.e., locally). however, a service to retrieve a patient's case history may require sending a message to a central application, which, after authorizing the request, sends back the required information (i.e., remotely). the ability to configure where services are invoked gives flexibility to re-route messages based on current needs. once the decision has been made for a service to be invoked remotely, a message creator creates the xml message using the correct schema. this message is transmitted to the receiving application that uses a message parser to interpret the xml message, and a message handler routes it to the correct service. since soap is based on remote procedure calls (rpc), results are returned to the calling application. fig. shows the message server component framework. an agent is an autonomous entity that is assigned specific tasks to perform. these tasks, typically performed as a background process, can assist in addressing jurisdictional configurability and alert notification requirements through the use of business rules. therefore, an agent's duties involve the periodic collection of rules and data and applying these rules to the data. we model an agent using the observer design pattern [ ] . in this design pattern, there exists a :n relationship between a subject and its observers. when the state of the subject is changed in any way, the subject's observers are notified so they can take the correct course of action. in our agent model, the subject is a gatherer that retrieves information from a data source (e.g., surveillance data stored in a relational database). once the gatherer has retrieved the information it requires, the observers are notified of the event. the observers then retrieve the information from the gatherer, analyze it and take the appropriate course of action. a notification receiver is informed of the results. we have implemented the agent using a thread so that it can operate on a sleep-wakeup schedule. for example, an export agent wakes up at a predetermined time and retrieves information from an application's database instance. one observer is setup to export this data to a centralized repository, while another observer is setup to export this data to another application. fig. shows the agent component framework. the workflow component defines a set of tasks to be completed, and the order in which they should be completed. these tasks can be a set of screens to display, or a set of auto-mated work items to perform. one example of a workflow is an escalation scenario, whereby each task performs a higherdegree work item than its predecessor. the workflow component assists in addressing the jurisdictional configurability and usability requirements. workflows are configured based on the jurisdiction in which the application is deployed without affecting the underlying code. fig. -modeling a workflow using a graph. fig. -business rule to validate date of birth. also, data entry is facilitated as a user is guided through the entire process. we model a workflow as a graph, g = (v, e), where v represents the tasks and e represents the action required to move from one task to another. for any, t i , t j ∈ v, there exists (t i , t j ) ∈ e if t i is a task that must be completed before completing t j (i.e., t j depends on t i ). for example, assume three data entry screens exist, d i , d j , d k ∈ v. selecting a value from a data element's drop-down menu in the first screen, d i , may lead to the second data entry screen, d j , to get more information. in this case, (d i , d j ) ∈ e. after completing data entry on the second screen, d j , the user is next shown the third data entry screen, d k . therefore, (d j , d k ) ∈ e exists. if the value on the first data entry screen, d i , which leads to the second data entry screen, d j , was not chosen, the user is shown the third data entry screen, d k . therefore, (d i , d k ) ∈ e also exists. fig. shows this example's workflow. modeling a workflow using a graph allows us to conduct a depth-first search in order to determine all paths in the graph from one node to another. this assists in determining what data needs to be removed based on revisiting a previous node, and choosing an alternative course. we enforce certain rules, since workflow graphs can become quite complex. a workflow must have a single start node and a single end node. furthermore, while navigation can occur between a node and the node that preceded it, in order to avoid infinite loops an action cannot directly point to a preceding node. business rules are capable of monitoring data stored in a database or memory, and making intelligent decisions based on that data. since databases house large amounts of data in distributed tables, valuable information can reside undetected among these tables. information such as a user logging in at an abnormal time, or the frequency of a person visiting different clinics within a -h period, could be critical knowledge to some application users. therefore, monitoring and extracting information from data stores is of great importance. we model business rules using a rules-based expert system. expert systems encode the knowledge of domain experts in order to solve particular problems. in a rules-based expert system, these problems are solved using production rules. a production rule is stated in the form: p → q, which states if p then q, where p represents a set of premises, or conditions, and q represents a set of conclusions, or actions [ ] . the conditions can be linked together using boolean logic (i.e., and, or, not) and organized into sub-conditions using parentheses (i.e., order of operations). testing these production rules and firing, or executing, those rules whose conditions are satisfied, transform an initial state of knowledge into a new state of knowledge. problems can therefore be solved in a logical manner. the rules and the data upon which those rules act are stored in a knowledge base. the knowledge within the knowledge base can constantly change as data is added, modified or deleted when different rules are executed. furthermore, the rules can also be added, modified or deleted, without modifying the source code, in order to dynamically evaluate the rule set. this helps reduce code complexity, as increasing the amount of logic needed to handle many different scenarios can lead to difficult to read code, or spaghetti code. spaghetti code can be difficult to thoroughly test and debug [ ] . furthermore, hard-coding logic inevitably leads to multiple software configurations of the same application, which further complicates maintenance [ ] . therefore, part of a business rules system's power is not locking an application into a predetermined set of rules. due to the dynamic nature of the business rules component, the jurisdictional configurability and alert notification requirements are addressed. policies can be encoded as rules are deployed to different jurisdictions as seen fit. furthermore, alerts and notifications can be configured depending on the data to be monitored and the behaviour to detect. we use forward chaining for the business rules inferencing engine. forward chaining systems start with an initial state, where certain facts are known, and the rules are used to infer an end result, where the conclusions are initially unknown [ ] . for example, fig. shows a business rule to validate date of birth. this business rule evaluates a data element to ensure that the integrity of the information collected is intact. in this case, the business rule ensures that if the date of birth has been specified, it cannot be empty, it must be in the format yyyy/mm/dd, and it must be a valid date. such a policy would not be acceptable in a small jurisdiction where the collection of a subject's full birth date would violate legislation. the policy deployed in that jurisdiction would be changed to only accept four digits. in both cases, the underlying application code remains untouched. this section outlines case studies of three applications built using the alpha architecture. in the past two and a half years, we have built applications for the public health agency of canada using the alpha architecture. the three applications presented in this section were chosen since they show a wide range of services used. the infectious disease surveillance system is a web-based application that collects case information on tuberculosis (tb) and sexually transmitted diseases (stds) in canada's federal penitentiary system. this data is sent to correctional service canada (csc) for data entry and analysis. the following central services are found in idss. the disease access service is a service that controls users access to case information. the access to information is both at the presentation level (what the user can view), as well as at the data level (what the user can retrieve, update or report). the disease access service uses the profiler component to implement its service. users in different roles and different locations can only access data they are permitted to see. therefore, a user in one institution cannot view data about subjects in another institution. an administrator, when creating a user, controls the level of access to the disease case information. the administrator, for example, can restrict access to individual data elements on a form, a section of the form, or the entire form. therefore, it is possible for users to see tests that have been run on a particular subject, but not the test results. the jurisdictional policy service is a service that handles the different policies of jurisdictions. each jurisdiction may have different requirements for its data. for instance, in one jurisdiction only an initial can be stored for a first name, while no such policy exists in another jurisdiction. the jurisdictional policy service uses the business rules component to implement its service. rules are encoded into the business rules component, and when a user attempts to save data, these rules are tested for data violations. since these rules are not hard-coded into the application, rules are created, deleted or modified as seen fit. therefore, if one policy rule is not applicable in a jurisdiction, it can be deactivated or removed. the message routing service is a service that handles the communication between different applications. applications may need to share data with other applications, or get data from other data sources. therefore, a communications service is required. the message routing service uses the message server and business rules components to implement the service. this service extends the message server component by implementing an xml schema and parser to send generic retrieval and update requests. these requests allow the application to use local as well as remote databases as its data source. the anti-microbial resistance surveillance system is a distributed, data collection system designed to gather information into one central repository for reporting and analysis purposes. there are three separate locations, guelph, ontario; st. hyacinthe, quebec and winnipeg, manitoba that currently input their disease and biological data from animals, food and humans into their respective local databases. this data is then exported periodically (e.g., every min) into the central repository in ottawa, ontario. the creation of a central repository enables the assessment of event relatedness, detection of time trends and geographical patterns. furthermore, resources at the separate locations have the ability to analyze their own data, and also the capability to perform analysis on the integrated data. the data is simultaneously accessible by selected resources in different office locations, and within different departments. the following central services are found in amrss. the message routing service uses the agent, message server and business rules components to handle communication. this service defines an agent to periodically send messages containing disease and biological data collected from animal, food and human specimens from the local databases to the central repository. this service extends the message server component by implementing the necessary xml schemas and parsers. business rules are used to route these messages to the correct service. the alert and notification service is a service that handles raising events of interest to a designated person or persons. an event of interest could be an error condition, a policy violation, or some other event of which a person should be notified. the alert and notification service uses the business rules component to implement its service. rules are created to look for data transformation, data transfer or data integrity failures. for instance, if a record is not imported correctly into the central repository, the local administrator must be notified of this event. the local administrator must also be notified if a record does not contain the correct mandatory fields. if such errors are detected, an error report is created and sent via email to the local administrator. the administrator can then use the report to remedy the situation. the application function access service is a service that handles access control to various functions of an application. the privileges a user has dictates what that user can and cannot do within an application. the application function access service uses the profiler component to implement its service. the data managed within the component is organized into the applications (e.g., administration tool, data viewer), properties of these applications (e.g., user management, code management), and attributes of these properties (e.g., create user, delete user). a local administrator is permitted to create user accounts for those at their location; however, they are not permitted to change the values of the data element pick lists. the central administrator has access to all application functions. the escsy system is a web-based application that collects information on sexually transmitted diseases in street youth. data is collected from youth in their teens and early twenties by public health nurses who use paper-based surveys. these surveys are then sent to phac for data entry and analysis. the following central services are found in the escsy system. the survey service is the central service in the escsy application. it is responsible for loading questions, saving responses and assisting in navigating through the survey. the survey service uses the workflow component to implement its service. the workflow component permits this service to implement features such as branch/skip logic to bypass questions that are based on answers to previous question; conditional logic to control such things as genderspecific questions from being answered by the wrong gender; full navigation to go to the first and last questions, the previous question, the next question, as well as being able to specify a specific question and data integrity to prevent navigation to those questions that cannot be viewed. fig. shows an example of a question. as in the idss application, the jurisdictional policy service uses the business rules component to handle policies. the escsy application has certain security policies to enforce. one of the policies is user access expiry. survey data is entered using data entry clerks, typically students. in order to prevent access to those that have not logged onto the system in a certain timeframe, a policy is in place to prevent access to those not involved with the project anymore. this is a policy that is not required by our other survey applications that use permanent staff. fig. shows the two rules involved to implement this policy. the rule engine, operating in stand-alone mode, tests these rules every day. if the rule finds an expired user, the rules will deactivate that user and send an email to the administrator explaining the action taken. two other services used by these applications are outlined below. these services assist in the management of the application environment. logging and auditing are fundamental to all applications, since they record exceptions, errors and other events of interest. the logging and auditing service provides a level of security by monitoring, and capturing application and network access, messaging requests, failure events and system misuse. the logging and auditing service uses the agent component to implement its service. applications built using the alpha architecture write all their logs and audits to the file system. the logging and auditing agent periodically collects the messages stored in these files and stores them in a database. the application management service works with the logging and auditing service to provide application-level management. the application management service is based on the fcaps model (fault, configuration, accounting, performance and security) [ ] . the application management service uses the agent and business rules components to implement its service. the application management agent periodically analyzes the log messages stored in the database from the logging and auditing service to determine if policy violations have occurred. for instance, the application management agent can determine if a fault exception has occurred which needs immediate attention (e.g., an application has produced a critical fault), or that some other potential faults have occurred (e.g., warnings from an application within min). furthermore, the application management agent also determines if a security breach has occurred (e.g., an application has produced an audit trail of a user logging in after work hours to retrieve sensitive information). the applications we have developed using the alpha architecture provide surveillance officers and analysts the tools they need to do their jobs. preliminary analysis is done using the jurisdictional policy service to perform frequency analysis and correlation of variables relevant to that jurisdiction. for instance, in idss, business rules have been created to run a frequency analysis on variables such as tests completed or positive tests in order to generate a summary report on hiv/aids, hepatitis a/b/c and tuberculosis. monthly graphic or textual reports can include region, institution and disease form-specific information. more in-depth analysis and statistical reporting were deemed outside the scope of our work based on the number of readily available commercial applications. however, the surveillance officers and analysts are provided a data export service that extracts the information from their application into a text file based on their specific variables and formats. these text files are then imported into a tool such as sas (sas institute inc., cary, nc), and analyzed using various statistical analysis methods [ ] . results from data collected within the escsy application have been presented at a variety of forums [ ] [ ] [ ] [ ] . a number of surveillance systems currently exist, as well as a few initiatives to create an inter-operable network of coordinating systems. we discuss one of these surveillance systems and two of the initiatives under way. the real-time outbreak and disease surveillance (rods) system [ ] [ ] [ ] is a syndromic surveillance system developed in the rods laboratory at the university of pittsburgh. a syndromic surveillance system is designed to identify outbreaks based on reported symptoms that precede a diagnosis [ ] . in the rods system, data is collected from patients' chief complaints during emergency department visits, as well as patient registration at acute care clinics. after removing patient identifying information, the data is automatically sent to the rods system using a health level- (hl ) message. the rods hl listener parses this message and routes it to a bayesian text classifier, which assigns it to a syndromic category. the data is then stored in the database for other applications to use. this data can then be analyzed to detect disease and bioterrorism outbreaks. the rods system is deployed within several health systems in the united states. two of the initiatives to create a network of surveillance systems in order to enhance surveillance in a larger domain are the canada health infoway project, and the public health information network (phin) project at the centers for disease control (cdc). the canada health infoway blueprint [ ] is a government funded program to create a pan-canadian electronic health record system (ehrs). the conceptual architecture of the blueprint outlines how point-of-service applications (e.g., case management applications at clinics, and hospitals) send information using standardized messages (e.g., hl ) to a health information access layer (hial). the hial, which defines services that can be used by inter-operating networks, stores information it receives into the appropriate repositories and registries. the cdc is working on a framework to implement a standards-based network of inter-operable public health care systems [ ] . the phin functions and specifications [ ] outline components for those intranet and internet-based health systems that transmit data with their public health partners (e.g., laboratories, local public health agencies). these components are focused on detection and monitoring, data analysis, knowledge management, alerting and response. the canada health infoway blueprint and phin framework are primarily interested in building an inter-operable architecture for a cross-jurisdictional network, whereas the purpose of our work is to build an architecture for creating applications that would live in this network. both the canada health infoway blueprint and phin framework work on the principle that a secure, standards-based network of public health systems lead to better public health management and response. a key success factor for creating an architecture for public health applications is that the application must be useful to a surveillance officer. if surveillance officers cannot change the surveillance targets in a timely manner, they cannot meet their public health objectives. therefore, the architecture, in order to be successful, must be flexible enough to allow both existing and new applications the ability to adapt to new surveillance targets so that surveillance officers can collect and analyze their data efficiently. in the alpha architecture, the data elements and data types collected within idss were easily modified after the surveillance officer required different data elements. also, in another application, the canadian tuberculosis reporting system (ctbrs), we were able to adapt to a set of different disease data forms. in both cases, the changes were made through configuration without modifying the underlying code. another key to the success of an architecture for public health applications is that the applications should assist users to enter or retrieve data efficiently so they can spend less time on administrative tasks and more time on their primary work (e.g., health care professionals spend more clinical time with patients, surveillance officers and analysts spend more time analyzing data). in the alpha architecture, feedback from the surveillance analysts has indicated this objective has been met, since they now have the ability to configure access to specific disease elements. finally, one more key to the success of an architecture is that each application's software development cycle should be reduced as time goes on. consequently, there will be a drop in costs associated with each new application. in the alpha architecture, the escsy survey application took three developers months to design and develop. by the time the third survey application was built, it only took one developer month to configure the necessary survey, alert/notification and policy services. furthermore, idss took five developers months to design and develop, but a similar surveillance application, ctbrs, took one developer only months to configure the necessary disease access, alert/notification and policy services. once again, the increased reliance on application configuration rather than development allowed the alpha architecture to meet these goals. furthermore, the work we have done on the alpha architecture has provided us a lot of information on building public health applications. these lessons are being applied to extend our work in the future. the usability of an application provides one of the biggest sources of frustrations for our clients. we have addressed this issue using the profiler component and, more specifically, a service such as the disease access service in idss. this service only presents the necessary data elements to a user based on their role, privileges and interest. therefore, a data entry clerk does not have to sort through a screen full of irrelevant data elements in order to enter data into one or two fields. furthermore, most of the field surveillance officers enter data onto paper forms that data entry clerks enter into the system. we are currently investigating the feasibility of using personal digital assistants (pdas) that can be distributed to the field in order for the data to be entered once and synchronized with the application at the end of each day. this will help automate the data entry process. an issue still to be resolved is the privacy concerns of information stored and transferred using a pda. we continue to investigate the extension and addition of new components and services through analysis of our software as it is produced. for instance, we are currently expanding our data entry workflow service for a new project that involves directing the user to different screens (tasks) based on information they provide. this service, like the survey service in the escsy application, uses the workflow component. to assist in this activity, we are also developing a workflow manager tool that will reside in the configuration layer to automatically create, edit and evaluate workflows. our latest project, a prototype for a mobile clinic system, is designed to be used for special events. this system, which is a combination of the idss and amrss systems, link up distributed, mobile clinics to a centralized repository to present aggregate data. business rules are created dynamically to monitor for anomalies, such as a high frequency of symptoms from one particular clinic or from all clinics. although the applications we have implemented so far have been based on infectious diseases, they can easily be adapted to track chronic diseases and other conditions. integrated systems that monitor and track a wide range of public health concerns can lead to a better understanding of certain diseases [ ] . finally, we continue to monitor the activities and advances made by the canada health infoway and phin projects so that our applications can integrate with these networks using messaging standards and protocols such as hl . in this paper, we have described an architecture that can be used to build public health applications. the architecture is based on four layers: a component layer, a service layer, a configuration layer and an application layer. we have outlined the components that form the core of the architecture. we have presented as examples three applications built using the architecture and the common service elements. these services illustrate how the components were configured in order to produce the application products. updated guidelines for evaluating public health surveillance systems: recommendations from the guidelines working group renewal of public health in canada the sars commission interim report: sars and public health in ontario a national agenda for public health informatics; summarized recommendations from the amia spring congress an integrated approach to communicable disease surveillance how outbreaks of infectious disease are detected: a review of surveillance systems and outbreaks responding to the challenge of communicable disease in europe implementing a network for electronic surveillance reporting from public health reference laboratories: an international perspective public health information technology functions and specifications, version . . centers for disease control the sars commission interim report: sars and public health in ontario software maintenance costs software engineering design patterns elements of reusable object-oriented software artificial intelligence structures and strategies for complex problem solving toward a more reliable theory of software reliability telecommunication system engineering prevalence and correlates of chlamydia infection in canadian street youth hepatitis b in canadian street youth: trends in immunity between sti and hepatitis c in canadian street youth - : what are the rates in this population? in: poster presentation presented at the international society for sexually transmitted diseases research (isstdr) canadian street youth: sexual behaviours and self-perceived risk enhanced surveillance of canadian street youth: an overview technical description of rods: a real-time public health surveillance system fever detection from free-text clinical records for biosurveillance syndrome and outbreak detection using chief-complaint data-experience of the real-time outbreak and disease surveillance project framework for evaluating public health surveillance systems for early detection of outbreaks ehrs blueprint: an interoperable ehr framework ( . ), canada health infoway sars and its implications for u.s. public health policy: "we've been lucky this work is supported and funded by the centre for infectious disease, prevention and control (cidpc), public health agency of canada; information technology management section (itms), public health agency of canada and correctional service canada (csc). key: cord- -oy e cpx authors: krishnan, lakshmi; ogunwole, s. michelle; cooper, lisa a. title: historical insights on coronavirus disease (covid- ), the influenza pandemic, and racial disparities: illuminating a path forward date: - - journal: ann intern med doi: . /m - sha: doc_id: cord_uid: oy e cpx the coronavirus disease (covid- ) pandemic is exacting a disproportionate toll on ethnic minority communities and magnifying existing disparities in health care access and treatment. to understand this crisis, physicians and public health researchers have searched history for insights, especially from a great outbreak approximately a century ago: the influenza pandemic. however, of the accounts examining the influenza pandemic and covid- , only a notable few discuss race. yet, a rich, broader scholarship on race and epidemic disease as a “sampling device for social analysis” exists. this commentary examines the historical arc of the influenza pandemic, focusing on black americans and showing the complex and sometimes surprising ways it operated, triggering particular responses both within a minority community and in wider racial, sociopolitical, and public health structures. this analysis reveals that critical structural inequities and health care gaps have historically contributed to and continue to compound disparate health outcomes among communities of color. shifting from this context to the present, this article frames a discussion of racial health disparities through a resilience approach rather than a deficit approach and offers a blueprint for approaching the covid- crisis and its afterlives through the lens of health equity. the coronavirus disease (covid- ) pandemic is exacting a disproportionate toll on ethnic minority communities and magnifying existing disparities in health care access and treatment. to understand this crisis, physicians and public health researchers have searched history for insights, especially from a great outbreak approximately a century ago: the influenza pandemic. however, of the accounts examining the influenza pandemic and covid- , only a notable few discuss race. yet, a rich, broader scholarship on race and epidemic disease as a "sampling device for social analysis" exists. this commentary examines the historical arc of the influenza pandemic, focusing on black americans and showing the complex and sometimes surprising ways it operated, triggering particular re-sponses both within a minority community and in wider racial, sociopolitical, and public health structures. this analysis reveals that critical structural inequities and health care gaps have historically contributed to and continue to compound disparate health outcomes among communities of color. shifting from this context to the present, this article frames a discussion of racial health disparities through a resilience approach rather than a deficit approach and offers a blueprint for approaching the covid- crisis and its afterlives through the lens of health equity. ann intern med. doi: . /m - annals.org for author, article, and disclosure information, see end of text. this article was published at annals.org on june . * drs. krishnan and ogunwole contributed equally to this work. t he coronavirus disease (covid- ) pandemic has killed more than persons in the united states ( ) . nationwide data indicate that ethnic minority communities, particularly black, latinx, and native or indigenous communities, suffer disproportionately ( ) ( ) ( ) ( ) ( ) ( ) . this has significant historical antecedents; as evelynn hammonds recently argued, epidemic diseases "lay bare and make visible inequalities in a society" ( ) . yet, at the onset of the crisis, few reported its effect on minorities ( ) . even now, we may not know the full scope and details. many states have published limited statistics, and race-stratified data, once fully released, will need to be carefully interpreted to address the causes of inequity rather than to perpetuate stigma and discrimination ( ) . unfortunately, this comes as no surprise to health equity researchers and historians of medicine and public health. the united states has a long history of racial and socioeconomic disparities, with the current pandemic further revealing the rifts created by historical injustice, structural racism, and interpersonal bias ( - ). although some have touted covid- as a "great equalizer" that strikes across age, sex, race/ethnicity, and geography, we contend that it has magnified the many "unequalizers" in our society ( , ) . to understand the current crisis, physicians and public health researchers have mined history for insights ( ) . most have focused on a century-old outbreak, the influenza pandemic (misleadingly called the "spanish flu"), because covid- most closely approximates it in scope and effect ( ) ( ) ( ) . of the accounts comparing the influenza pandemic and covid- , only a notable few discuss race ( , , ). yet, a rich, broader scholarship on race and epidemic disease as a "sampling device for social analysis" exists ( ) ( ) ( ) ( ) ( ) ( ) . given the excessive mortality due to covid- in minority communities, reexamination of such historical antecedents is fruitful. although this scholarship hesitates to offer predictions, this kind of analysis can provide orienting frameworks, reveal nuance, and modulate our approach to the current crisiswhich has been called "unprecedented," reflecting a lack of historical context. we examine the historical arc of the influenza pandemic, focusing on black americans and showing the complex, sometimes surprising ways it triggered particular responses both within a minority community and in wider racial, sociopolitical, and public health structures. shifting to the present, we frame a discussion of racial health disparities through a resilience approach versus a deficit approach and offer a blueprint (table) for approaching the covid- crisis and its afterlives through the lens of health equity. elected leaders should exercise an abundance of precaution when facing potential public health threats. providing accurate information, overpreparing, and not underreacting are key. leaders (whether community based or elected) are role models. communities of color may look to these persons to guide their own behaviors. persons in positions of power or influence should be held to high standards and model the importance of strict adherence to strategies aimed at controlling and reducing infectious disease spread. transparency and communication are key to timely adoption of mitigation strategies by the general public; when these are absent, erosion of trust ensues. early transparency and communication are key to timely adoption of mitigation strategies by the general public. however, even with these strategies, historical precedence may make it difficult for communities of color to trust information from the government. in this scenario, it is especially important to engage trusted messengers, such as community leaders and faith-based organizations, to help deliver critical information. for communities of color, each conversation and transfer of information is an opportunity to either rebuild trust or further substantiate mistrust. elected leaders should thus be held accountable for misinformation, and the public should be aware of credible sources of information. counting and reporting are critical for measuring disparities in health and planning equitable interventions. technology should be leveraged to support data collection for public health surveillance and social service needs. data collected on disease incidence should be stratified by key demographic factors. blaming specific groups for infectious disease spread is counterproductive and can be dangerous for the groups indicted. disinformation based on racism and stigma is unacceptable; leaders in all sectors should rely on scientific facts to guide conversations on infectious disease spread. they should maintain neutral positions and should not place blame on specific groups. social determinants of health are key drivers of health disparities and also affect the ability to participate in infectious disease mitigation strategies. policy initiatives must address social determinants of health before pandemics arise. support for social services must be better integrated into the health care system. health systems should anticipate increased need for social support during pandemics and have strategies in place to deliver services to the most vulnerable populations. this includes enhanced access to technology to support telecommunication for vulnerable populations. chronic medical conditions are significant contributors to morbidity and mortality during the pandemic. health care policy changes are needed to enable access to primary care and preventative services throughout the life course. there will be long-term sequelae related to covid- (both directly because of virus-related morbidity and indirectly as a result of reduced access to care during social distancing periods). the health care system should plan for and anticipate a surge in the need for primary and specialty care services. institutional and structural forces keep communities of color from achieving their full potential. a restorative justice approach that includes the following strategies, among others, should be used: • investments in early education • financial assistance for higher education or trade schools; forgiveness for previously accumulated education debt • investment in public housing; fair and equitable access to home loans • fair and equitable access to business loans; incentives for minority-owned businesses • investment in neighborhood environments: resources for community-led neighborhood violence prevention strategies, increases in green space, walking trails, reduction in food deserts • universal access to health care, including mental health care • integration of faith-based organizations into the health care system • restructuring of the criminal justice system; employment opportunities after incarceration communities of color lead, persevere, and innovate. they play an essential role in building bridges toward trust in the health care system and improving health outcomes within their communities. their contributions help to advance science and medicine and deserve recognition. communities of color should be given opportunities to actively participate in agenda setting, research, and policy initiatives aimed at improving their communities so they can be recognized and acknowledged for their contributions. building and restoring trust is an ongoing process that is necessary to advance medicine, science, and health care. this can be aided through some of the following measures: • support for strategies aimed at improving and maintaining a diverse health care workforce • community-based participatory research throughout all phases of the research process (design, implementation, dissemination, and evaluation) • utilization of trusted community partners and community health workers to aid in community education; improvement in recruitment and participation in research, including clinical trials; gathering of quantitative and qualitative data in the field throughout all phases of pandemic response covid- = coronavirus disease . * all phases should be responsive to the possibility of future waves of disease. historical insights on covid- , influenza, and racial disparities on black americans, who, for example, accounted for an overwhelming number of the deaths in the - smallpox epidemic ( ) . contagion also augmented biologically deterministic beliefs, including that blacks were innately immune to certain diseases. during the - yellow fever epidemic in philadelphia, white physicians, such as benjamin rush, asked black community leaders absalom jones and william gray to "furnish nurses to attend the afflicted" because of the erroneous assumption that blacks could not contract the disease ( , ) . however, in the context of these preceding epidemics, the influenza pandemic forms a unique case study. although all-cause morbidity and mortality in the early th century was higher for black americans than white americans, the few studies examining racial differences in the pandemic found that the black population had lower influenza incidence and morbidity but higher case fatality ( , ) . black physicians shared this view, as evidenced in the journal of the national medical association and local newspaper articles ( , ). meanwhile, white public health figures, like chicago commissioner of public health john dill robertson, used these findings to justify biological determinism, concluding that "the colored race was more immune than the white to influenza" ( ) . rebuttals to these innate immunity theories circulated in the black print media. respected and widely read periodicals, such as baltimore's afro-american, the chicago defender, and the philadelphia tribune, carefully documented influenza's effect, with personal columns, church registers, and town updates listing the many community members who had the "flu," shaming those not taking it seriously, or mourning others, such as a promising young teacher and morgan college graduate ( - ). other articles warned black americans to take adequate precautions and discounted theoretical immunity: "while the death rate from the epidemic of influenza is not as high as the white death rate, colored people are far from being immune of the disease" ( ) . in december , african american columnist william pickens debunked the claim of a white west virginian who claimed the "influenza germ had shown that god was partial in favor of black people." pickens countered that for whites, "when negroes die faster, it is often escribed [sic] to their inferiority," but if spared, "well, that proves they are not human like the rest of us" ( ) . these critiques highlight differences between pandemic coverage and explanatory models in the "mainstream" versus black press-the latter was community-centered, focused on trusted sources and internal solutions, and skeptical about the veracity and benevolence of white responses. how do we account for black americans' lower influenza infection rates and all-cause mortality but higher case-fatality rate during the influenza pandemic? alfred crosby hypothesizes that higher exposure to the less virulent early wave may have made black americans less susceptible to the fall/winter wave ( , ) . this assumes many interlinked circumstances, including higher likelihood of blacks living in over-crowded environments and therefore greater exposure during the spring/summer wave; poorer access to sanitation, potable water, and hygiene than white counterparts; and early exposure conferring immunity against the deadlier autumn wave. segregation may also have functioned as an unintentional cordon sanitaire, quarantining blacks from whites. finally, recall that supporting data are limited by likely underreporting ( ) . nonetheless, it is worth noting the higher case-fatality rate, which could be attributed to several factors still present today: higher risk for pulmonary disease, malnutrition, poor housing conditions, social and economic disparities, and inadequate access to care. in sum, if a black person caught influenza in , they were more likely to die-an outcome which, despite lower infection and all-cause mortality rates, has significant repercussions. aggregate influenza data before and after the - season reflect a more familiar pattern: significantly higher morbidity and mortality among nonwhites compared with whites ( ) . that the outcomes of black americans did not improve in the interim suggests that the influenza pandemic did little to mobilize national responses for improving their health status, a precedent that we hope is not replicated in the current crisis. the broader context of the pandemic is critical for understanding the historical, as well as contemporaneous, landscape of health disparities. a confluence of factors, including social policies of racial exclusion and discrimination, unequal provision of health care, housing inequality, malnutrition, chronic respiratory disease, and increased epidemiologic burden of infectious diseases (such as tuberculosis, typhoid fever, whooping cough, and infant diarrheal illnesses), contributed to lower life expectancy for black americans ( ) . new academic disciplines, such as anthropology, evolutionary biology, genetics, and eugenics, helped promote theories of biological determinism, which compounded older views attributing poor health outcomes to the inferior qualities of black americans ( ) . the jim crow laws boosted white supremacy with these ideologies to enforce racial segregation, and between and , in the thick of the influenza pandemic, approximately half a million blacks fled the punitive south for midwestern and northern cities in the now-famous great migration. however, those cities often greeted them with prejudice, stigma, segregationist policies, and violence, allegedly aimed at improving public health. a march chicago daily tribune headline proclaimed, "rush of negroes to city starts health inquiry"; during the pandemic, the headline "half a million darkies from dixie swarm to the north to better themselves" appeared. reporter henry m. hyde named southern black migrants as disease vectors: "compelled to live crowded in dark and insanitary rooms; they are surrounded by constant temptations" ( , ) . these views provided justification for draconian public health ordinances and restrictive housing covenants that maintained housing color lines and prevented black chicagoans from leaving overcrowded conditions ("the black ( ) . residential segregation also played a role in the outbreak in baltimore, the first large american city to pass drastic housing legislation in . consequently, many black baltimoreans lived in "alley districts" or high-occupancy "tenant houses" with poor sanitation and ventilation and higher rates of epidemic disease ( , ) . influenza overwhelmed medical resources straining under the burden of urban density, unequal living conditions, and a high concentration of military training camps ( , ) . downplaying by authorities like health commissioner dr. john d. blake, who called it the "same old influenza" physicians have long treated, exacerbated the problem ( ). blake eventually reversed course, imposing citywide restrictions and "social distancing," but not in time to stanch the tide. segregation and structural racism extended to medical education and health care delivery, but community mobilization, well under way before the pandemic, was a counterbalance. by the early th century, black activists and professionals led many health institutions and flagship organizations: howard university college of medicine (founded in ), tuskegee institute hospital and nurse training school (founded in ), meharry medical college (founded in ), the national medical association (founded in ), and the national association of colored graduate nurses (founded in ). at the same time, the flexner report (published in ) disadvantaged minority health education-only of the initial black medical schools survived its reforms, and they struggled financially during the influenza pandemic ( ) . black nurses, excluded from world war i service by the u.s. army medical corps and the red cross and battling for inclusion in the u.s. armed forces nurses corps, nevertheless served on influenza frontlines. in october , afro-american declared that these essential workers were "at a premium," noting that the self-same "red cross leaders are appreciative of the response colored women have made . . ." ( ) . yet, black patients were often disbarred from care, leading to local and decentralized efforts to provide care within the community. black professionals took great pride in their role fighting influenza. as dr. john p. turner wrote ( ): the negro physician played a most prominent part in treating and relieving victims of every race . . . [yet] will possibly never be cited in the history to be written of the epidemic. however we want to call to the attention of the medical profession of america the unselfish devotion to duty that impelled three thousand legal practitioners of medicine of african de-scent to work night and day to aid in checking the monster scourge. although most black health professionals did not receive due praise or recognition, disruptions in the wake of world war i and the pandemic did shift the u.s. medical landscape. it was partly because of the "scarcity of white medical men" as well as ardent community efforts and activism that places like the harlem hospital desegregated ( - ) ; louis t. wright, later a prominent surgeon and civil rights activist, became the first black physician to join its staff in ( ) . historians remark that, unlike other cataclysmic events, the pandemic left minimal traces in public memory and culture; its neglect has led to its being called the "forgotten pandemic" ( ). however, this assertion overlooks its multivariate effect on the african american community. although the influenza pandemic does not reveal ready associations between deleterious social, cultural, and economic conditions and poor outcomes (aside from higher case-fatality rate) for black americans, the gaps in historical documentation may reflect inherent disparities and consequences of limited racial/ethnic data collection. this absent archive may indeed have been a setback for public health and health equity-a missed opportunity to intervene on the basis of the specific contexts and unique vulnerabilities of different groups. in this way, the influenza pandemic is an illuminating case study for understanding the role of pandemics in the history of health disparities and the broader health equity movement. for black americans, surviving and fighting the pandemic was a catalyzing step up the social ladder, a cause for communal effort and activism, and a justification for profound engagement with health, which was seen as bound to the greater social condition. it concretized the spirit of community resilience and helped contribute to desegregation and the nascent civil rights movement. however, because of minimal national mobilization to improve the health of communities of color, it also compounded mounting distrust in the u.s. government to intervene and help improve the health and lives of its nonwhite citizens, a wariness that we see replayed in the covid- pandemic. reflecting on the influenza pandemic in the setting of covid- , we note important parallels while recognizing many differences in context. despite the past century's therapeutic evolution, we find ourselves in a situation similar to , without a vaccine or proven treatments for a deadly disease. furthermore, structural inequities have historically contributed and continue to compound disparate health outcomes in communities of color. evaluating historical trends is critical for health equity work, and through attending to the complexities of the pandemic, we have the opportunity to ground our current and future strategies in this historical context, deliver a more equitable pan- historical insights on covid- , influenza, and racial disparities demic strategy, and reduce disparities in marginalized communities. as physicians who also serve other roles (health equity researchers, historians of medicine, educators, and advocates), we propose several areas for intervention and mobilization throughout the various phases of pandemic response. delaying swift public health measures significantly affected the pandemic curve trajectory in the influenza pandemic. cities that enacted swift and sustained nonpharmaceutical interventions had lower excess mortality rates than their counterparts ( - ) . similarly, initial failure to acknowledge severe acute respiratory syndrome coronavirus as a credible threat hampered containment and mitigation efforts ( ). several months later, as much of the nation strategizes reopening, we must maintain vigilant mitigation strategies while aligning recommendations with emerging epidemiologic data. failure to do so could result in new waves of disease, as was the case in . within the african american community, specific communication barriers, augmented by a lack of covid- -related demographic data, contributed to underestimating the pandemic's effect. misinformation and recycled, erroneous narratives about black immunity circulated through social media ( ) . historical distrust of biomedicine amplified these effects ( ) . however, as available data emerged outlining covid- 's devastating disparities, black organizations, leaders, and media outlets aggressively campaigned to dispel myths, implored citizens to heed sanitation and containment advice, and advocated for community resources. this kind of community-led strategy has repeatedly been critical in counteracting national failures to protect minorities. furthermore, such interventions bridge divides forged by historical mistrust-they are central to dissemination of information and community activation ( ) . however, misinformation, oversight, and delayed mitigation strategies alone do not fully explain differential covid- incidence. many have deeply analyzed the effect of social determinants on covid- disparities ( , , ) . this historical inheritance, of which the influenza pandemic forms just episode, shapes how social conditions obstruct minority participation in public health mitigation and containment measures. it also extends to risk factors for chronic disease development, making african americans more susceptible to covid- -related morbidity and mortality ( ) . as a result of redlining, for instance, minority residential environments bear substantial barriers to health optimization, such as reduced green space access, disproportionate tobacco and alcohol marketing, low perceived neighborhood safety, and food deserts ( ) . health equity researchers have proposed reforms, including interventions by local governments to provide food, housing, education, employment, and technological support, but this approach is necessarily reactive rather than reparative and preventive ( , ) . an advantage of the current era compared with is our ability to collect robust data that can inform a more proactive strategy. structural, environmental, and economic data on essential goods and services can enhance epidemiologic data. when stratified at the level of key social determinants of health, this information can be used to identify which communities are most vulnerable and ensure prudent and equitable dissemination of resources. in addition to the relief response, we must examine the nature of blame and stigma during pandemics, paying particular attention to dangerous narratives of personal responsibility as a key driver of health outcomes ( ) . these accounts place the burden of differential outcomes on minorities rather than acknowledging the lasting legacy of structural racism. they also detach minority health from that of the majority rather than viewing it as part of the nation's collective mission. the trajectory of the covid- pandemic remains uncertain; it may abate, or we may face resurgent waves during reopening, as seen during the influenza pandemic. if the latter, we must acknowledge the history of public health response, correcting prior mistakes and attempting to duplicate applicable practices. if the former, we must still consider our path toward equity in recovery. challenges for communities of color will include long-term covid- sequelae, exacerbation of underlying chronic conditions, and mistrust in the health care system, perhaps reinforced by the current crisis. creating antidotes to this mistrust will be critical; components should include collaboration with trusted community and media partners, a diverse health care workforce to offer racially concordant care teams, and community-based participatory research. this will in turn support the actions needed to reduce disparities, including recruiting a representative population into future covid- -related clinical trials and epidemiologic studies, ensuring adequate uptake during vaccination campaigns, enhancing engagement with primary care for improved chronic disease prevention and management, and seeking the narrative and lived experience of minorities to guide future public health communication and strategy ( , ) . however, there is reason to be hopeful. perhaps the most important conclusion drawn from an analysis of the influenza pandemic is that minority communities are resilient, are resourceful, and find restoration in community. the most successful strategies to advance health equity would be to ) examine the historical arc contextualizing current disparities in vulnerable communities; ) recognize the inherent strengths in these communities, empowering them to participate in research and generate solutions alongside those who traditionally hold power; ) acknowledge the contributions of frontline workers in communities of color; ) prepare for future public health emergencies by enhancing minority civic participation; and ) use a restorative justice framework to acknowledge and make amends for the structures contributing to disadvantages in these communities ( , ) . taken together, these strategies provide the opportunity to use this challenging moment to transform clinical and public health practice by grounding it in social justice. although the covid- pandemic will eventually abate, its aftershocks will be perceptible for generations. there is no doubt that it will change public health practice and clinical delivery, which are intimately intertwined. yet, it will also shift the political and social landscapes. as arundhati roy recently wrote in "the pandemic is a portal": "we can choose to walk through it, dragging the carcasses of our prejudice and hatred, our avarice, our data banks and dead ideas . . . or we can walk through lightly, with little luggage, ready to imagine another world. and ready to fight for it" ( ) . when the dust settles in the wake of covid- , let us not allow ourselves to fall into a great amnesia, another forgotten pandemic. let us remember whom this disproportionately affected and why. taking this as impetus for mobilization, let us begin to rewrite the story of health disparities in america. in this new chapter, we will be better prepared to offer all citizens a fair and just opportunity to attain their highest level of health. current author addresses and author contributions are available at annals.org. covid- dashboard covid- fatalities covid- infection rates based on education and race. abc news chicago's coronavirus disparity: black chicagoans are dying at nearly six times the rate of white residents, data show hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease -covid-net, states, march - arizona: percent of covid- deaths are native americans. indian country today early data shows african americans have contracted and died of coronavirus at an alarming rate. propublica accessed at www.propublica.org/article/early-data -shows-african-americans-have-contracted-and-died-of-coronavirus -at-an-alarming-rate on how racism is shaping the coronavirus pandemic minority groups at risk as states withhold, provide partial covid- racial data institute of medicine. unequal treatment: confronting racial and ethnic disparities in health care. national academies pr; . . washington ha. medical apartheid: the dark history of medical experimentation on black americans from colonial times to the present you are a sweet, beautiful guy and my best friend. if anyone is #newyorktough it's you covid- and african americans this time must be different: disparities during the covid- pandemic historian draws parallels between the spanish flu and today's coronavirus pandemic the spanish flu killed more than million people. these lessons could help avoid a repeat with coronavirus the influenza pandemic and covid- . pbs race colors america's response to epidemics: a look at how jim crow affected the treatment of african americans fighting the spanish flu. the undefeated history in a crisis-lessons for covid- african americans, public health, and the influenza epidemic. public health rep childhood's deadly scourge: the campaign to control diphtheria infectious fear: politics, disease, and the health effects of segregation sick from freedom: african-american illness and suffering during the civil war and reconstruction immunities of empire: race, disease, and the new tropical medicine, - the health and physique of the negro american the geography and mortality of the influenza pandemic influenza: the mother of all pandemics the influenza epidemic and jim crow public health policies and practices in chicago an account of the bilious remitting yellow fever, as it appeared in the city of philadelphia, in the year . thomas dobson the myth of innate racial differences between white and black people's bodies: lessons from the yellow fever epidemic in race and influenza pandemic in the united states: a review of the literature american pandemic: the lost worlds of the influenza epidemic report and handbook of the department of health of the city of chicago for years to inclusive. department of health of the city of chicago; . . personal. afro-american ( - ) whole families in lewes have flu. afro-american proquest historical newspapers: the baltimore afro-american proquest historical newspapers: the baltimore afro-american closed on last sunday: one pastor boasted that services would be held at his church as usual. the board of health acts. philadelphia tribune baltimore afro-american baltimore afro-american. december greenwood pr; . . crosby aw. america's forgotten pandemic: the influenza of protection of racial/ethnic minority populations during an influenza pandemic germs and jim crow: the impact of microbiology on public health policies in progressive era american south half a million darkies from dixie swarm to the north to better themselves. chicago daily tribune black metropolis: a study of negro life in a northern city germs know no color: racial segregation in baltimore during the influenza pandemic of - apartheid baltimore style: the residential segregation ordinances of - / /archives/baltimore-tries-drastic-plan-of-race-segregation-strange -situation the flexner report and black medical schools black nurses in the great war: fighting for and with the american military in the struggle for civil rights epidemic influenza and the negro physician desegregating harlem hospital: a centennial. the new york academy of medicine nonpharmaceutical interventions implemented by us cities during the - influenza pandemic public health interventions and epidemic intensity during the influenza pandemic baltimore city plans coronavirus ad campaign to combat myth that african american residents are immune. baltimore sun coronavirus fight shifts to baltimore's poor neighborhoods as city leaders battle mistrust. baltimore sun public communications and its role in reducing and eliminating health disparities. in: institute of medicine (us) committee on the review and assessment of the nih's strategic research plan and budget to reduce and ultimately eliminate health disparities examining the health disparities research plan of the national institutes of health: unfinished business failing another national stress test on health disparities covid- and health equity-a new kind of "herd immunity hospitalization and mortality among black patients and white patients with covid- social sources of racial disparities in health a game plan to help the most vulnerable data and policy solutions to address racial and ethnic disparities in the covid- pandemic what the surgeon general gets wrong about african americans and covid- . cnn. reducing racial inequities in health: using what we already know to take action restorative justice & other public health approaches for healing: transforming conflict into resiliency. lorenn walker blog accessed at www.ft.com/content/ d f e - eb- ea- fe-fcd e ca on history of medicine historical insights on covid- , influenza, and racial disparities current author addresses: dr. krishnan: johns hopkins university school of medicine suite # - a critical revision of the article for important intellectual content historical insights on covid- , influenza, and racial disparities key: cord- -j tvmvd authors: batsukh, zayat; tsolmon, b.; otgonbaatar, dashdavaa; undraa, baatar; dolgorkhand, adyadorj; ariuntuya, ochirpurev title: one health in mongolia date: - - journal: one health: the human-animal-environment interfaces in emerging infectious diseases doi: . / _ _ sha: doc_id: cord_uid: j tvmvd the asia pacific strategy for emerging diseases (apsed) requires collaboration, consensus, and partnership across all the different actors and sectors involved in different aspects of emerging disease. guided by apsed, mongolia has established a functional coordination mechanism between the animal and human health sectors. surveillance, information exchange and risk assessment, risk reduction, and coordinated response capacity and collaborative research have been identified as the four pillars of the zoonoses framework. intersectoral collaboration has been clearly shown to be a crucial tool in the prevention and control of emerging zoonotic diseases. a “one health” strategy has been implemented under the concept of ‘healthy animal-healthy food-healthy people’. an intersectoral coordination mechanism established between the veterinary and public health sectors has expanded its function to incorporate more work on food safety, emergency management, and effects of climate change on zoonotic diseases. its membership includes the human health sector, the veterinary sector, the national emergency management agency, the environment sector, emergency management and inspection authorities, and the world health organization (who). the main outputs of the coordination mechanism have been strengthened surveillance and response activities and laboratory capacities. the coordination mechanism has also strengthened the surveillance and response capacity of neglected zoonotic diseases, such as brucellosis, anthrax, and tick-borne diseases. through regular meetings and brainstorming sessions, both sectors have developed joint operational plans, a long-term risk reduction plan – , initiated a prioritization exercise and risk assessment for zoonotic diseases, and reviewed and revised standards, procedures, and communication strategies. in , a list of experts on major zoonoses were identified from different sectors and formed into a taskforce to identify the focal points for rabies, brucellosis, and vector-borne diseases. as a result, disease control strategies are now linked to scientific research and epidemiological expertise. mechanism established between the veterinary and public health sectors has expanded its function to incorporate more work on food safety, emergency management, and effects of climate change on zoonotic diseases. its membership includes the human health sector, the veterinary sector, the national emergency management agency, the environment sector, emergency management and inspection authorities, and the world health organization (who). the main outputs of the coordination mechanism have been strengthened surveillance and response activities and laboratory capacities. the coordination mechanism has also strengthened the surveillance and response capacity of neglected zoonotic diseases, such as brucellosis, anthrax, and tick-borne diseases. through regular meetings and brainstorming sessions, both sectors have developed joint operational plans, a long-term risk reduction plan - , initiated a prioritization exercise and risk assessment for zoonotic diseases, and reviewed and revised standards, procedures, and communication strategies. in , a list of experts on major zoonoses were identified from different sectors and formed into a taskforce to identify the focal points for rabies, brucellosis, and vector-borne diseases. as a result, disease control strategies are now linked to scientific research and epidemiological expertise. mongolia is a landlocked country in east and central asia, situated between and bordering china and russia, and with a population of . million as of . the country has the lowest population density in the world, one person per . km . mining and agriculture, and are the two main sectors of the mongolian economy. for centuries, the mongolians have been engaged in animal husbandry, raising horses, sheep, goats, cattle, and camels. agriculture, primarily herding, is the traditional basis of the mongolian economy, contributing about % of gdp and providing % of national employment. livestock husbandry is the main economic pillar, vital for public good, and the significant source of export income. due to increasing urbanization and socioeconomic development of country in recent years, migration from rural to urban and suburban areas has been increasing. in , only . % of the population resided in rural areas. approximately, % of the population is nomadic or seminomadic. administratively, mongolia is divided into provinces, and the capital city, ulaanbaatar. mongolia has an extreme continental climate with long, cold winters and short summers, during which most precipitation falls. the temperature is as low as - to - °c in the winter and can reach °to °c in the summer. global climate change is believed to have had an influence on the climate; the annual average climate temperature has risen by . °c over the last years, and in the last years, the temperature has risen faster and the rainfall has decreased in mongolian forest-steppe regions. due to environmental and human impacts in the last few years many rivers, streams, and lakes have dried, pasture growth has decreased by - %, pasture plant species numbers have reduced and it has resulted in an increase in land degradation and desertification. natural disasters such as drought, heavy snowfall, flood, snowstorms, windstorms, extreme cold and hot temperatures, and earthquakes recurrently occur throughout the year. mongolia is very dependent on nature and climate due to its traditional nomadic lifestyle throughout four seasons of the year. the large herder population has a greater chance of zoonotic infections. as the mongolian economy is heavily reliant on herding and agriculture, the harsh winters and periodic droughts have adverse effects on livestock and agriculture, and also on the health status of the population. the livestock population was . millions as of , down from . million at the end of . pig and poultry population are not prominent. endemic zoonotic diseases such as brucellosis, anthrax, rabies, plague, and tick-borne diseases create important public health problems. in recent years, endemic zoonoses have expanded and outbreaks of number of transboundary diseases have emerged in both animals and humans. climate change and extreme weather conditions have had an adverse effect on biodiversity, distribution of animals, and microflora, which can lead to the emergence of zoonotic agents and create favorable conditions for disease outbreaks. over bacterial and viral and parasitic zoonotic diseases were reported in animals. six out of diseases listed as transmissible diseases notifiable to the oie were reported in mongolia, and four diseases have a potential risk for further spread. the significance of zoonoses is increasing due to improved animal husbandry practices, climate change, desertification, and developments in the mining sector. in spite of the progress achieved, anthrax, brucellosis, tick-borne diseases, and rabies still constitute a threat to human health and welfare. the the overall vision of the coordination committee is to have ''strong human and animal health sectors, together with emergency response and national inspection agencies working in partnership toward the attainment of a healthier community''. the coordination committee has responsibility for developing joint policy on the prevention and control of priority zoonotic diseases; for approving action plans produced by a technical working group; for making recommendations on risk assessment, early warning and response activities during outbreaks; for reviewing and revising zoonotic diseases standard operational procedures (sops) and guidelines to reflect intersectoral collaboration; for providing methodological assistance to improve the capacity of professional institutions at the national and subnational level; for coordinating cooperation among different sectors in carrying out early detection and response functions; and for monitoring and evaluating overall zoonotic disease prevention and control. the director-general of the national centre for zoonotic diseases in the moh serves as secretariat, and is responsible for routine coordination and management. before the establishment of the coordination committee, moh and mofali developed a written memorandum of understanding (mou) to conduct joint surveys on zoonotic diseases in - . both sectors exchanged annual statistical reports and conducted joint serological surveys. the results of the survey helped define the distribution of major zoonoses which are important to both animal and human health. the surveys identified new diseases in mongolia, such as tick-borne encephalitis, west nile fever, lyme disease, rickettsia, and q fever. the joint survey promoted collaboration between two sectors. the new diseases have been added to the list of notifiable diseases to reflect current threats. however, most of the activities were aimed at gathering information about zoonotic pathogens only. notable changes observed in the two sectors during the survey were transferred by the joint task to surveillance with ongoing and systematic collection of information in order to define the extent of disease problem, and to disseminate this information to improve public health awareness, early warning, diagnosis, prevention, and control. the first meeting of the intersectoral coordination committee took place in march , and was attended by its members, the secretariat, the technical working group and evaluation team, as well as by representatives from who and fao. the outcome of the meeting was discussion of the draft joint operational plan. the first activity was to map existing capacity and surveillance systems, and response and risk reduction measures in both the animal and human health sectors. based on the results of this assessment, an operational plan of action was developed to address the gaps and to improve zoonose control strategies. quarterly meetings have been held and priorities set for actions and interventions. regular meetings between veterinary and public health professionals proved to be an important activity to improve and stimulate intersectoral cooperation. during times of emergencies, both sides communicated frequently and joint technical working group meetings were conducted. a good example of this is the brainstorming joint response review meeting of veterinary and human health authorities in september following the outbreak of anthrax in animals and humans. all meetings are organized in cooperation with the who and other international organizations. the cost of organizing joint meetings and conferences was paid back by the harmonization of legislation, joint planning, and sharing of resources. this included sharing information and surveillance data and cooperation at the local level in outbreak response. this cooperation has been tested during real time outbreaks and the lessons learned from those exercises used to improve the rapid response measures. the coordination committee organized the first national conference on zoonoses in june . the participants were professionals from both the human and veterinary sectors at national and subnational levels. this was the first ever joint meeting between two sectors at a professional level. the meeting reviewed results of joint assessment on existing capacity and system for surveillance and response in the following areas: • human resources • response capacity • information and surveillance • laboratory • logistics and supplies. after the national conference, the intersectoral coordination mechanism was formally set up at all levels in mongolia. at the community level, social awareness, public education, and media play an important role. it has also enabled the use of better risk communication and health education strategies at the community level. risk communication and promotion of programs directed primarily at occupational risk groups and school children were implemented with assistance from local government. at the national level, the coordination mechanism was aimed at improving information exchange, expertise sharing, mutual technical support, and harmonization of legislation. in , a joint strategy for long-term risk reduction of priority zoonotic diseases for - was developed by the ministries of health and of food and agriculture. information sharing, surveillance, risk assessment, and risk reduction the intersectoral coordinating committee on zoonoses carried out a prioritization exercise and risk assessment of zoonotic diseases in january . these included endemic zoonoses reported in humans, zoonoses reported in animals, vector-borne diseases, and diseases at risk of being imported. a total of zoonoses were identified that are important for both animal and human health sectors. the technical working group that consisted of veterinary, public health, laboratory, research institute, and academic personnel held a series of discussions and conducted detailed risk assessments. who's prioritization tool as well as other countries' methodologies and tools were adopted for this prioritization exercise. the priority diseases, namely, plague, avian influenza, anthrax, brucellosis, rabies, tickborne encephalitis, echinococcosis, and tularemia were defined as diseases that required a coordinated surveillance and response. endemic diseases like brucellosis and anthrax, which have been listed by who as ''neglected'' were identified as priority diseases by moh and mofa. the exercise specially defined malaria, dengue fever, glanders, toxoplasmosis, west nile fever, japanese encephalitis, hemorrhagic fever with renal syndrome, and cryptosporidiosis as diseases that should be targeted for collaborative research. the coordination committee developed sops for information sharing, surveillance, and response for the priority diseases such as avian and pandemic influenza, anthrax, tick-borne diseases, rabies, brucellosis, plague, and some parasitic diseases. the veterinary and health sectors routinely cross-notify and exchange information, based on the sops. in addition to surveillance data, both sectors should exchange outbreak information within h, and laboratory data and event information (immunization, cluster of cases, livestock abortion, sudden death of animals, survey results, food-borne disease) on a monthly basis. weekly disease information has been shared with moh, mofa, who, fao, and other partners through an electronic newsletter since march . mongolia has one of the highest incidences of human brucellosis in the world. national brucellosis surveillance was established in the , and a test-and-slaughter strategy commenced in . the government implemented a vaccination strategy from to . as a result, the prevalence of animal brucellosis has decreased from to . %. however, in the s human brucellosis re-emerged following transition to free market economy, collapse of systems that were responsible to public health issues and lack of resources to continue surveillance accordingly. in , a new vaccination strategy was introduced with the aim of eradicating the disease by , but attempts to control the disease have been unsuccessful because of inconsistent strategies with respect to vaccination of livestock and the detection and elimination of infected animals from the herd. the seroprevalence of brucellosis in humans, livestock, and dogs was investigated as a pilot project in sukhbaatar and zavkhan province with support from swiss development agency. the results of the study by veterinary and medical epidemiologists served as a baseline for assessing and monitoring the effectiveness of a conjunctival vaccination campaign in . in addition, the conjunctival vaccine campaign has assisted the development of new strategy for national brucellosis control and for livestock export. despite the increase in the number of registered animal brucellosis cases, the moh did not report an increase in the number of human brucellosis. in mongolia, the disease incidence is largely unknown because many cases are missed due to a lack of diagnostic facilities at the subnational level. only - % of cases of acute human brucellosis are reported, and it is estimated that less than one in cases are reported indicating a significant under-reporting. animal sector surveillance data helped the human health sector to review surveillance and laboratory practice to improve reporting. brucellosis is identified as one of priority zoonoses for both animal and human health sector. in , animal and human sector have started baseline prevalence survey. over , serum samples from five major species of animals and , serum samples from human were collected and laboratory investigation were carried out, following oie recommendations. a mass vaccination campaign has been implemented with the aim of controlling and eradicating animal brucellosis by . the country was divided into three sectors and . million animals were vaccinated in in st sector, with a future plan to vaccinate animals in remaining two sectors, and then to provide annual vaccination of newborns. in response to growing burden of anthrax in the mongolia, a technical working group has developed a strategy for the prevention and control of human and animal anthrax. this is the first risk reduction disease strategy that has been prepared with involvement of human, animal, emergence management, inspection agency, food safety and intelligence authorities, and with international partners. the strategy has been based on global best practice and experience gained over the past years of responding to outbreaks as well as sporadic cases of anthrax. a gis-based risk map has been developed for anthrax to provide a common platform. in addition, a joint technical working group has been established with professionals from the institute of veterinary medicine, the national centre for zoonotic diseases, the central veterinary diagnostic laboratory to act as a professional advisory, and technical implementation body to develop methodological recommendations and policy documents for approval by relevant authorities. in response to increasing numbers of rabies cases in wildlife, the veterinary and public health sectors have combined with local government over the past years to conduct community education and awareness activities in schools, workplaces, and among the general population. on world rabies day , the moh organized a rabies awareness and prevention campaign and conducted training for healthcare workers, veterinarians, school doctors. the moh also distributed brochures and posters for children, parents, and dog owners on rabies prevention, and video spots and cartoons were produced and broadcasted by media. the veterinary sector also initiated dog vaccination, and stray street dogs were destroyed in four districts. an avian influenza surveillance program has been established in wild birds in order to provide an early warning system and to improve the existing surveillance network. the surveillance team consisted of representatives from the veterinary, health, environment, inspection, and other related institutions, and was a good example of multisectoral cooperation. the two human and animal sectors have developed an epidemiological atlas of zoonotic diseases in mongolia, . the atlas contains approximately maps that illustrate the distribution of major or rare and neglected zoonotic diseases. every map contains key information about the infectious agent including: icd- code, epidemiology, epizootiology, climate data, vegetation, transmission, incubation period, clinical findings, therapeutic options, and key references. in addition, the atlas includes population density, livestock density, antibiotic use, immunization coverage, and other relevant factors and will be regularly updated. it will be made available online by . the use of gis tools and geo-referenced, subnational level epidemiological data allowed the production of maps that improve spatial quality of previous maps. it was shown that diseases such as brucellosis, glanders, and bovine leucosis in animals have been introduced into previously unaffected areas by cattle movement. the atlas will lay the basis for novel, evidence-based methodologies to estimate the population at risk and burden of disease, ultimately leading to more targeted interventions. the atlas has also helped to streamline field data collection. joint risk assessment and investigations have been conducted after cross-notification of outbreaks of foot-and-mouth disease, newcastle disease, human and animal anthrax, rabies, and avian influenza in wild birds. during outbreaks of anthrax, a rapid response team consisting of veterinarians, medical epidemiologist, inspectors and emergency officers, implemented quarantine and movement restrictions, and developed risk maps using gis. animal vaccinations, enhanced surveillance in the food market, and health education and communication activities has led to effective outbreak response. the subclinical, gastrointestinal form of anthrax was identified for the first time by the rapid response team. existing rapid response infrastructure has been improved into multisectoral joint rapid response teams that operate at the district and provincial levels; rapid response teams have been trained and established in provinces. working together has made it possible to prevent zoonotic diseases, not merely to react to them once they have occurred. laboratory integration, surveillance activities, and recognition of the importance of risk assessment have also increased. under the apsed framework, communication and cooperation of veterinary and human health laboratories have increased significantly in the last years. laboratories share information, experience, diagnostic kits, laboratory specimens and lab equipment for surveillance, response, and research activities. health laboratories have benefited from more advanced laboratory resources of veterinary laboratories, including personnel. during an unusual outbreak of human anthrax in , the veterinary laboratory assisted in validating results and undertook confirmation tests. subnational veterinary laboratories in all provinces have been equipped with pcr equipment and reagents. the veterinary laboratory also supported laboratory diagnosis of a rabies outbreak in uvurkhangai province and in an unusual anthrax outbreak in khovd province. following annual serological surveys, the analysis of the laboratory findings was carried out jointly by laboratory staff from the veterinary and health laboratories, and the methodologies used in both sectors were reviewed and experiences shared. as a result of human and animal sector collaboration, the diagnostic capacity of human health laboratories has been improved significantly. new advanced methods and techniques for isolation, identification, and confirmation of zoonotic viral and parasitic pathogens have been introduced at the national level. a number of commercially available diagnostic kits have been introduced for diagnosis at the nrcidnf and the number of diseases diagnosed by molecular assays has increased to . serological and molecular diagnostic tools have become available for the diagnosis of tick-borne encephalitis, lyme disease, and rickettsia which had previously been diagnosed only by clinical presentation. however, hantavirus, west nile virus, japanese encephalitis virus, crimean congo hemorrhagic fever virus, dengue virus, and many others cannot be diagnosed due to technical limitations, and thus the true burden and epidemiology of these diseases in mongolia is still unknown. in addition to the collaboration with veterinary laboratories, training in advanced countries is seen as important for increase capacity at the laboratory diagnostic level. since , over professionals have been trained in laboratory biosafety in russian federation, kazakhstan, people's republic of china, germany, and japan. approximately % of the trained lab professionals were from provincial veterinary and medical diagnostic laboratories. as a result of collaborative molecular biology research with foreign colleagues from various countries including russia, china, the usa, germany, and japan, various techniques such as clustered regularly interspaced short palindromic repeats (crispr), duplex polymerase chain reaction (pcr), variable number tandem repeats (vntr), multiple loci vntr analysis (mlva), have been introduced to research and diagnostic laboratories for animal and human diseases, and have determined unique and specific genes of y.pestis, b.anthracis, rabies virus, tick-borne encephalitis virus, and some species of rickettsia. in addition, hantavirus, west nile virus, anaplasmosis, erlichiosis, and toxoplasmosis were newly identified using these techniques. several complications still exist that constrain sharing of resources between human and animal diagnostic laboratories and the biggest challenge for the intersectoral coordination committee on zoonoses will be to change the legal and ethical environment. mongolia is planning to establish a laboratory network between public health, clinical, veterinary, and food laboratories in - . lessons learned from managing previous outbreaks highlighted the importance of advocacy and public education. a communication and behavior change strategy was reviewed by the coordinating committee meeting in . it emphasizes the need for advocacy and a public education campaign targeted at high-risk groups. a proactive approach in building effective communication with media was also stressed. endemic zoonoses such as plague, anthrax, and vector-borne diseases occur regularly due to a lack of public awareness, and there is a high infectivity rate of brucellosis among herdsmen and veterinarians. unsafe cultural traditions are widespread among the general population, such as consumption of raw milk, undercooked sheep liver, and sour cream made from raw milk. public health education programs need to be aimed at specific community groups, school children, and occupational groups, taking into account culture, beliefs, traditions, educational level, social status, occupation, and age. an involvement of community and local government in health education through health education in schools and in the workplace has proved to be effective. health messages on how to prevent infection with tick-borne diseases and the production of leaflets and posters were distributed before the tick season. in addition, a monthly press conference has been initiated by the moh to ensure important public health messages are widely disseminated; the first press conference held on march advocated a one world, one health approach to public health. regular awareness programs are conducted by state veterinary and animal breeding department, institute of veterinary medicine, and the moh through tv programs, brochures, video spots, cartoons for children, and press conferences. training materials and courses for risk reduction measures and interventions were developed for anthrax, plague, tick-borne diseases, brucellosis, and avian influenza collaboratively by animal and human health sectors. joint staff training activities and short training courses on mosquito biology and surveillance, risk assessment of common zoonotic diseases, data management, database design, vector-borne diseases have been conducted for medical and zoonotic epidemiologists, biologists, laboratory staff, and meteorologists. tick-borne diseases such as tick-borne encephalitis, lyme disease, and rickettsia are a growing concern in mongolia, as their prevalence continues to increase with expansion into new areas. pastoral animal husbandry, climate change, desertification, development of mining sector, new tick species, and vector distribution in mongolia combine to create an important public health problem. to mitigate these risks, a korean international cooperation agency (koica) funded project has supported vector surveillance, climatic monitoring and community education to high-risk population. this initiative is multisectoral, and is bringing together people with different backgrounds and sectors. at the regional level, emerging diseases surveillance and response (esr) and malaria, vector-borne and parasitic disease (mvd) units are working together. climate change studies are complex and require multisectoral collaboration. building on the achievements of the intersectoral coordination mechanism, a comprehensive surveillance system for vector-borne diseases has been established. surveillance procedures have been developed for anaplasmosis, q fever, tickborne encephalitis, tickborne boreliosis, rickettsia, and erlichiosis. tick distribution and species are monitored in relation with microclimate and human infections. erlichiosis and anaplasmosis, toxoplasmosis, and crimean congo hemorrhagic fever infections were identified for the first time in humans, and anaplasmosis platys was identified for the first time in ticks. the veterinary laboratory is undertaking genetic studies on ticks. correlation of infected tick density with variations in human incidence and climate determinants has helped to identify factors associated with disease transmission. risk maps on tick prevalence, density, biotype, climate data, and vegetation has provided useful public health information for early warning. increased risk communication and staff training has resulted in improved protective behavior of the nomadic population. the national center for zoonotic diseases has established good collaboration and partnerships with many international organizations and institutions from various countries including china, kazakhstan, russia, japan, switzerland, the usa, and germany. epidemiologists interested in zoonoses have been cooperating with chinese academy of inspection and quarantine since on collaborative research directed at understanding the natural foci and the conditions affecting disease incidence each side of the border of both countries. this collaborative research has also enhanced laboratory capacity, including a substantial donation of virology laboratory equipment to the ncidnf by the chinese academy of inspection and quarantine. the laboratory will be basis for conducting cross-border surveillance, on-the-job training of laboratory staff, and confirmation of events and diseases of public health importance. the ncidnf conducts collaborative research on plague and tick-borne diseases with the bundeswehr institute of microbiology of munich. both institutions carry out annual joint field investigations and expeditions. the results from these studies have been published and presented at an international zoonoses conference held in mongolia. extensive research and cross border surveillance of bacterial, parasitic, and viral diseases have been conducted in collaboration with gamalei institute of epidemiology and microbiology, and natural foci of leptospirosis, cryptosporidiosis, and toxoplasmosis have been detected for the first time in mongolia. studies on the molecular biology of plague, tick-borne diseases, and other emerging diseases have been undertaken by veterinary and public health specialists with colleagues from the university of florida. an important part of the collaboration with the university of florida is a 'one health' training program which started in , and which attracted a number of staff members from the institute of veterinary medicine and the moh. it is hoped that the course may attract the us and international students. the curriculum will include studies in environmental health, modern laboratory techniques, epidemiology, biostatistics, food safety, climate change, gis, toxicology, and zoonotic infections research. apsed has facilitated an intersectoral coordination mechanism between human health and other sectors. however, although ongoing risk assessments are conducted during outbreaks, there has been no comprehensive cross-sectoral risk assessment for all priority zoonoses. evidence-based decision making and response, and utilization of risk assessment findings, need to be further improved. it has also been realized that an enabling legal environment is critical for effective control of zoonoses. the annual intersectoral simulation exercise has been a useful way to review response capability, and to update and revise the coordinated response guidelines. subnational level planning and information sharing between veterinary and health epidemiologists, however, is still weak. at the local level, the involvement of the veterinary health departments is crucial for effective monitoring of instances of zoonotic disease in wild and domestic animals. there is also need to improve both the health laboratory capacity and in epidemiological capacity in the animal sector. during the annual review meeting in , the need for developing and implementing a common monitoring and evaluation framework was highlighted, and poor coordination and confusion over roles and responsibilities among veterinary, health and inspection agencies on food safety, and import and export control need to be addressed. financial contribution is crucial for the success of zoonoses control in the country, so that effort from mofali and moh is requested to have more efficient way to raise the fund and harmonize international donor recourse, by drawing attention of potential donors for the activity in the zoonoses field. we believe a good foundation has been established for a coordination mechanism between the veterinary and public health sectors, and the generic capacity for zoonoses control and prevention has improved considerably. in addition, the zoonoses coordination framework has attracted more resources from international partners and allowed pooling of resources. thus while an important process has started, there is still much to do to reduce the risk of zoonotic diseases in mongolia. editorial addition asia pacific strategy for emerging diseases (apsed) and its role in responding to zoonotic disease threats. john s mackenzie, curtin university, perth, and the burnet institute, melbourne apsed was developed in as a joint initiative by the south-east asian (searo) and western pacific regional offices (wpro) of the who to meet the challenges of emerging diseases that pose serious threats to regional and global health security (who ) . apsed provided a common strategic framework for countries and areas of the two regions to strengthen their capacity to manage and respond to emerging diseases including epidemic-prone diseases, and to develop the capability to comply with the core capacity requirements of the new international health regulations ( ) . it had the support of all regional countries ( in searo and in wpro), and thus represented countries with a combined population of . billion people, more than half of the world's population. the development of apsed was greatly influenced by several major emerging zoonotic disease events in the asia pacific region, and especially by the emergence of severe acute respiratory syndrome (sars) and highly pathogenic avian influenza h n (hpai), as well as the initial outbreak and continued recurrences of nipah virus. during the first years of the strategy, the two regions experienced a number of infectious disease threats including the establishment of hpai as an endemic disease, the rapid global spread of pandemic influenza h n , and a large number of other acute events with significant public health impact. taken together, these provided important lessons in pandemic response and demonstrated the need to further strengthen public health emergency preparedness and improve monitoring and evaluation. apsed ( ) recognized that many emerging diseases were zoonoses, and that an important component of the strategy was the development of plans to detect, manage, and respond to infectious diseases at the human-animal interface. during the first years of the strategy, a guide was developed in collaboration with colleagues from the world organization for animal health (oie) and the food and agriculture organization of the united nations (fao) entitled 'zoonotic diseases: a guide to establishing collaboration between animal and human health sectors at the country level' to assist countries with their planning (who ). thus, considerable progress was made in the two regions toward strengthening core capacities needed to prevent, detect and respond to threats posed by emerging diseases, and has provided a good foundation for expanding the scope of apsed. this led to a biregional consultation to explore how to take the strategy forward for the next years, resulting in the development of apsed ( ) (who ). the new strategy has expanded to eight focus areas, including zoonoses, with a strong statement recognizing the importance of zoonotic diseases and with an undertaking to continue working in collaboration with fao and oie and other partners … 'to contribute to the concept of ''one health''', and acknowledging that reducing the risk of transmission of zoonotic diseases requires close collaboration between and links with the food safety, environment, and wildlife sectors. it also states that the experience and lessons learned with hpai (h n ) provide a good foundation to consolidate and strengthen national and regional coordination mechanisms for surveillance information-sharing and coordinated responses by human and animal health sectors. in response to the strategy, a number of countries in the regions have developed plans to coordinate and collaborate between their human and animal sectors, and in some instances, also their environmental sectors, through a 'one health' approach. mongolia is one such example, and the description of their plans and activities clearly demonstrate how they are building a sustainable and collaborative approach toward managing zoonotic diseases, and developing the capacity to diagnose and respond to new emerging disease threats-a good example of operationalising 'one health' at the national level. other examples are given in the chapters by dr g gongal and dr b coughlan. zoonotic diseases: a guide to establishing collaboration between animal and human health sectors at the country level. world health organization regional office for south-east asia, new delhi, and the regional office for the western pacific key: cord- -m vjo ym authors: lee, hyojung; nishiura, hiroshi title: recrudescence of ebola virus disease outbreak in west africa, – date: - - journal: int j infect dis doi: . /j.ijid. . . sha: doc_id: cord_uid: m vjo ym objectives: there have been errors in determining the end of the ebola virus disease (evd) epidemic when adhering to the criteria of the world health organization. the present study aimed to review and learn from all known recrudescence events in west africa occurring in – . methods: background mechanisms of five erroneous declarations in guinea, liberia, and sierra leone during – were reviewed. results: three cases of recrudescence were suspected to have been caused by sexual contact with survivors, one to be due to international migration, and one was linked to a potentially immunocompromised mother. the three sexual transmission events involving survivors—the first two in liberia and one in sierra leone—required days, > days, and approximately days, respectively, from discharge of the survivors to confirmation of the recrudescent case. conclusions: the events of recrudescence were associated with relatively uncommon routes of transmission other than close contact during burial or care-giving, including sexual transmission, possible immunocompromise, and migration. recognition of the sexual transmission risk among survivors could potentially involve discrimination, which may lead to under-ascertainment. the end of an outbreak must be determined objectively (nishiura et al., ) . for the ebola virus disease (evd) outbreak in west africa from to , the world health organization (who) recommended securing days (world health organization, ) , or twice the observed maximum incubation period, from the time at which the last case was found negative for the virus at second testing. subsequently, the country without evd cases would enter a period of heightened surveillance lasting days to monitor for any other occurrence of infection. as there have been errors in determining the end of an outbreak when adhering to the criteria mentioned above, it would be valuable to learn from the events of evd recrudescence occurring in liberia, guinea, and sierra leone. this will inform wiser decision-making in the future. the present study aimed to review all known recrudescence events in west africa occurring during the period - . a recrudescence event was defined as the reappearance of at least one confirmed case of evd in a country where the end of evd had been declared in advance. the term 'recrudescence' is used, because the reappearance of evd in west africa has been associated with persistent activity of infection arising from already infected humans. who reports and other sources were reviewed in an analysis of all known recrudescence events occurring from to (world health organization, ; sheri, ; farge and giahyue, ; dahl et al., ; dakaractu, ; center for infectious disease research and policy, ) . in the statistical analysis, the background mechanisms of erroneous declarations of the end of an evd outbreak in west africa during - were investigated. a survey of the demographic variables of recrudescent cases was performed (i.e., age and sex), and the most likely source of infection and the dates of illness onset and confirmation were also obtained. by examining the date of confirmation of the purported last case (i.e., the case before the recrudescent case) and the date on which the outbreak was declared to have ended, the following were calculated: ( ) the time interval between successive confirmations, ( ) the number of days from burial or the second negative testing result of the last case, and ( ) the number of days in heightened surveillance. a total of five cases of recrudescence were identified ( figure ): three occurred in liberia and one each in guinea and sierra leone (world health organization, ; sheri, ; farge and giahyue, ; dahl et al., ; dakaractu, ; center for infectious disease research and policy, ) . two were male and three were female ( table ) . one of the three cases in liberia was caused by inter-country migration, and therefore may be better stated as recurrence rather than recrudescence (world health organization, ; dakaractu, ) . that case was associated with viral exposure at a funeral in guinea (dakaractu, ) . sexual transmission involving survivors was suspected for three cases (world health organization, ; sheri, ; center for infectious disease research and policy, ) . of these, one in liberia was documented as linked to a survivor who had recovered days before confirmation of the recrudescent case (dahl et al., ) . similarly, the recrudescent female case in sierra leone is believed to have been due to sexual transmission (world health organization, ; center for infectious disease research and policy, ). in guinea, three probable unconfirmed deaths considered as consistent with evd were observed in advance of the confirmed recrudescence on march , (world health organization, dahl et al., ; dakaractu, ) . virologically, the causative virus of the recrudescence event was demonstrated to be closely related to the virus isolated previously in the same country (dahl et al., ; dakaractu, ) . the route of transmission in a -year-old male in liberia remains unknown, but intra-household transmission during the mother's pregnancy from the immunocompromised mother to the -year-old boy was suspected (world health organization, ; farge and giahyue, ) . the time interval from laboratory confirmation of the perceived last case to confirmation of the recrudescent case ranged from to days (table ). all observed intervals were longer than the mean serial interval; i.e., the time from illness onset in the primary case to that in the secondary case, estimated at . days (who ebola response team, ) . from the latest date of either burial or second negative test result, it took - days to confirm the cases of recrudescenceall more than double the -day waiting period. recrudescence events occurred - days after the declaration of the end of the outbreak. the time lags from declaration to recrudescence were all within the -day period of heightened surveillance. the three sexual transmission events involving survivors-the first two in liberia and one in sierra leone-required days, > days, and approximately days, respectively, from discharge of survivors to confirmation of the recrudescent case. the recrudescence events were not associated with the common routes of evd transmission, such as close contact during burials or care-giving, but rather with other routes or reasons, including sexual transmission, possible immunocompromise, and migration. while use of a -day waiting period posed practical difficulties from to , the present exercise was not intended to criticize that fixed, transparent criterion. even with the use of a more objective approach, including serial interval distribution (e.g., as applied for middle east respiratory syndrome in south korea (nishiura et al., ) ), this may not have sufficiently captured the involvement of sexual transmission and other reasons for recrudescence. the need to consider the prevention of sexual transmission via survivors when declaring the end of an epidemic poses a dilemma. this is because the recognition of such a risk among survivors could potentially involve discrimination, and fear of stigma may lead to under-ascertainment. the results of this study suggest that the supposed end of an evd epidemic could be divided objectively into several different types. for instance, the restriction of movement for cases and exposed individuals-i.e., socially 'costly' interventions-could be ceased through use of a -day waiting period. this may not necessarily ensure a long enough waiting time for an uncommon route of infection. meanwhile, heightened surveillance and the avoidance of risky sexual intercourse should be set at > days, i.e. the observed maximum in this study, echoing a study on the transmission network (mate et al., ) ; ideally this duration should be set at months considering the persistence of the virus in semen (deen et al., ) . these are essential to monitor and prevent recrudescence through uncommon routes of transmission. it is intended to investigate the objective determination of the outbreak in a more explicit manner using mathematical modeling techniques. not applicable. sierra leone reports second new ebola case cdc's response to the - ebola epidemic -guinea related ebola cases in guinea and liberia ebola rna persistence in semen of ebola virus disease survivors -preliminary report female survivor may be cause of ebola flare-up in liberia. reuters molecular evidence of sexual transmission of ebola virus objective determination of end of mers outbreak surge of ebola in liberia may be linked to a survivor who ebola response team. after ebola in west africa -unpredictable risks, preventable epidemics criteria for declaring the end of the ebola outbreak in guinea, liberia or sierra leone. geneva: world health organization world health organization. ebola situation report. geneva: world health organization table recrudescence of ebola virus disease in west africa hn received funding from the japan agency for medical research and development (amed), japanese society for the promotion of science (jsps) kakenhi (grant numbers kt , k , and h ), japan science and technology agency (jst) crest program (jpmjcr ), and ristex program for science of science, technology and innovation policy. hl has received financial support through the jsps program for advancing strategic international networks to accelerate the circulation of talented researchers. the funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. the authors declare no conflicts of interest. ( ) a duration from confirmation of the last case to confirmation of the re-emerging case. b duration from burial or the second negative testing result of the last case to confirmation of the re-emerging case. c a declaration was made on the day following the negative laboratory test and, thus, the specified date minus does not equal days, as in the next column to the right. key: cord- - u e wr authors: thomas, james c.; miller, reid title: codes of ethics in public health date: - - journal: international encyclopedia of public health doi: . /b - - - - . - sha: doc_id: cord_uid: u e wr ethics in public health were distilled into a professional code relatively recently, with adoption of a code by the american public health association (apha) a little more than years ago. in that short time, however, the code has influenced standards for public health practice and education. a few organizations representing disciplines within public health, such as the society for public health education (sophe) and the american college of epidemiology (ace), have written ethical guidelines specific to their professions and consistent with the apha code of ethics. codes related explicitly to public health ethics in countries other than the us have yet to be written. in , an experiment conducted by the american public health service was ended after a whistle-blower revealed what was widely considered as unethical conduct. the experiment, named after the local collaborator, the tuskegee institute, withheld known cures from low-income, undereducated black men infected with syphilis. following this and other instances of unethical medical experimentation, the federal government issued the belmont report, providing ethical guidelines for the conduct of research on human subjects (the belmont report, ) . the belmont report served as a starting point for ethics in the era of twentieth-century medical technologies. some of those technologies, such as vaccines to prevent infections and antibiotics to prevent their transmission, are used in public health. but public health differs from clinical health care in a number of significant ways. in medicine, it is the interaction between the care provider and the patient that leads to the most ethical issues. in this interaction, medical ethics seeks to protect the autonomy of the patient. in public health, however, most ethical issues arise from the interaction between an agencysuch as a city health departmentand the population it is serving. a public health agency is often protecting some people within a population from others. for example, it may need to isolate an infectious person in order to prevent transmission to others. in so doing, the autonomy of the infected person is constrained in the interest of the community. because of these fundamental differences between medicine and public health, the belmont report, and policies subsequently derived from the report, do not adequately address a number of important issues in public health. epidemics of highly pathogenic organisms in recent years have underscored the need for ethical guidelines in public health. they include epidemics of severe acute respiratory syndrome (sars), ebola, and the highly anticipated but not yet realized h n influenza pandemic (gostin et al., ; hsin-chen hsin and macer, ; ovadia et al., ; singer et al., ; who, ; thomas and miller, ) . common ethics challenges have included the distribution of scarce resources for curing or preventing infection, protection of populations without unnecessarily infringing on individual rights, ensuring that health-care workers fulfill their duties when they and their families are at risk, and ensuring that health-care organizations fulfill their obligations to employees who are taking risks. codes of ethics in public health are a recent development. while the american medical association (ama) approved its first code of ethics in , the american public health association (apha) approved its code in (thomas et al., ) . the late emergence of a code of ethics in public health may reflect that, until recent years, many public health institutions were led by physicians who would naturally recognize medical codes of ethics. moreover, for centuries, physicians were regarded as the overseers of all health-related matters. only in the past few decades have nonclinical health professionals begun to assume more authority in health care and prevention. the landmark, institute of medicine (iom), report on public health set the tone for the writing of the u.s. public health code of ethics. it focused on strengthening federal, state, and local government agencies in their mission of protecting and promoting the health of the public. the impetus for developing a public health code of ethics originated within a group of public health practitioners, including providers of public health services, staff of public health nonprofit organizations, government officials, and academics. they had come together for leadership training by the public health leadership institute. as a leadership exercise, they sought to identify ethical principles that aligned with the issues they were encountering in their work more closely than the common principles of medical ethics. the group began by identifying typical ethical challenges and responses that had surfaced over time from their experiences in public health. from these, they identified principles, such as the use of scientific data for making decisions. these principles led in turn to an initial draft of the code. three professional perspectives were represented in the drafting of the public health code of ethics: law, philosophy, and public health practice. when confronted by an ethical dilemma, such as the use of quarantine to limit transmission of a highly pathogenic infection, lawyers typically reflect first on what the law allows and on the precedents in case history. philosophers typically expand on the situation to explore all the philosophical threads and identify what various schools of philosophical thought would have to say about the ethical conundrums. public health practitioners are relatively pragmatic. they commonly seek to minimize the number of people harmed by the epidemic. although they may not name the philosophy, this perspective is closely aligned with utilitarianism, which seeks the greatest good for the greatest number of people. in some instances, public health practitioners also appeal to human rights, another ethical school of thought, which acts as a counterbalance to a utilitarian calculus that can sideline a minority of the population; for example, the few placed in quarantine for the benefit of the community have a right to have certain basic needs met while in quarantine. lawyers and philosophers familiar with public health weighed in on early drafts of the code developed by the public health practitioners. input on the next draft was sought during an open meeting at an annual conference of apha. the final code was officially endorsed by apha in (table ) . reflecting the key interaction between an agency and the population it serves, noted above, the public health code addresses the actions of agencies rather than individuals. most other codes of ethics address the actions of individuals within the profession. of the principles of the public health code of ethics, state obligations of public health institutions and state ethical principles of public health policies and programs. for example, the th principle in the code states, "public health institutions should ensure the professional competence of their employees." a few constituent disciplines of public health have their own codes of ethics. each narrows in on particular concerns within the profession. in doing so, they enumerate more principles than does the code for public health. the society for public health education (sophe) code of ethics consists of sections or principles categorized into six articles or responsibilities. the responsibilities are to the public, the profession, employers, the delivery of health education, research and evaluation, and professional preparation. as an example of the level of detail, the first section of the third article (pertaining to responsibilities to employers) states, "health educators accurately represent their qualifications and the qualifications of others whom they recommend." the american college of epidemiology (ace) ethics guidelines addresses topics, such as the professional role of epidemiologists, providing benefits, and protecting confidentiality. the code of ethics of the american college of healthcare executives (ache) consists of principles grouped into six responsibilities: to the profession, to patients, to the organization (i.e., an employer), to employees, to the community, and to report violations of the code. other traditional disciplines within public health either refer to the public health code of ethics or the codes of related fields. none of the principles in the three codes for constituent organizations (sophe, ace, and ache) disagree with the public health code of ethics. each affirms accountability, equity, confidentiality, professional competence, and more. one potential area for disagreement between the guidelines for epidemiologists and the public health code of ethics relates to advocacy. some epidemiologists assert that advocating for certain groups or needs compromises scientific objectivity. yet, the public health code states that "public health should advocate and work for the empowerment of disenfranchised community members." ace avoided this controversy by stating both sides of the issue: "in confronting public health problems, epidemiologists sometimes act as advocates on behalf of members of affected communities. advocacy should not impair scientific objectivity." a few principles in the public health code of ethics are not addressed in the other codes. the public health code, for example, emphasizes the importance of prevention and addressing the fundamental causes of disease. it also speaks clearly of the need to allow communities to have input into policies affecting them and for collaboration among institutions and organizations. the absence of these principles from the other codes does not represent a disagreement. rather, it highlights the value of a code that transcends the perspectives of the constituent disciplines within public health, one that maintains a broader, interdisciplinary perspective. the agreement and complementarity of the codes demonstrate that one code does not supersede another. a professional needs both the global perspective of the public health code and the particularity of the code of his or her narrower profession. the codes of ethics cited above were written for american professional organizations. codes related explicitly to public health ethics in countries other than the us have yet to be written. instead, one can find lists of values and principles that are often invoked in the context of a particular public health threat. pandemic influenza planning provides one example. the world health organization project on addressing ethical issues in pandemic influenza planning divided themselves into four working groups: . equitable access to therapeutic and prophylactic measures; . ethics of public health measures in response to pandemic influenza; table the u.s. public health code of ethics . public health should address principally the fundamental causes of disease and requirements for health, aiming to prevent adverse health outcomes . public health should achieve community health in a way that respects the rights of individuals in the community . public health policies, programs, and priorities should be developed and evaluated through processes that ensure an opportunity for input from community members . public health should advocate and work for the empowerment of disenfranchised community members, aiming to ensure that the basic resources and conditions necessary for health are accessible to all . public health should seek the information needed to implement effective policies and programs that protect and promote health . public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community's consent for their implementation . public health institutions should act in a timely manner on the information they have within the resources and the mandate given to them by the public . public health programs and policies should incorporate a variety of approaches that anticipate and respect diverse values, beliefs, and cultures in the community . public health programs and policies should be implemented in a manner that most enhances the physical and social environment . public health institutions should protect the confidentiality of information that can bring harm to an individual or community if made public. exceptions must be justified on the basis of the high likelihood of significant harm to the individual or others . public health institutions should ensure the professional competence of their employees . public health institutions and their employees should engage in collaborations and affiliations in ways that build the public's trust and the institution's effectiveness and should obtain the community's consent for their implementation . the role and obligations of health-care workers during an outbreak of pandemic influenza; . issues that arise between governments when developing a multilateral response to a potential outbreak of pandemic influenza (who, ) . the working group addressing public health measures identified four values: ( ) public health necessity (a government should exercise its public health police powers on an individual or group only if the person or group poses a threat to the community such as the likelihood of spreading an infection), ( ) reasonable and effective means (the methods by which a threat is addressed should have a reasonable chance of being effective), ( ) proportionality (the human burden imposed by a public health regulation should be proportionate to the expected public health benefit), and ( ) distributive justice (the risks, benefits, and burdens of public health action should be fairly distributed, thereby precluding the unjustified targeting of an already socially vulnerable population). in addressing the tension between the rights of individuals and the good of the community, this group noted the siracusa principles, which are internationally recognized limitations on human rights established at a meeting in siracusa, italy (united nations economic and social council, ) . they are as follows: l the restriction is provided for and carried out in accordance with the law. l the restriction is in the interest of a legitimate objective of general interest. l the restriction is strictly necessary in a democratic society to achieve the objective. l there are no less intrusive and restrictive means available to reach the same objective. l the restriction is not drafted or imposed arbitrarily, that is, in an unreasonable or otherwise discriminatory manner. other lists of values in public health ethics are on website in the section titled relevant websites, below. principles and rules for research ethics have developed along a path separate from codes of ethics. they have evolved out of recommendations resulting from high-profile research abuses such as nazi war crimes and the tuskegee study of untreated syphilis. the principal concerns in research ethics are informed consent and the protection of vulnerable individuals such as prisoners and minors. to ensure compliance with prescribed procedures in federally funded research, there exists an institutional infrastructure reaching from the federal government to individual institutions such as universities. institutions found not to comply with the prescribed procedures can lose their license to conduct federally funded research until they are found to be compliant once again. codes of ethics for the practice of public health do not have the enforcement structures seen in research ethics. rather, the codes are aspirational, articulating the values and expectations of the profession. they are a means of being transparent and enabling the public they serve to hold them accountable for their actions. in addition, they serve as a tool for identifying and addressing ethical issues. for example, ethical issues in the application of genomics to public health were identified by considering genomics in light of each principle of the public health code of ethics in turn . since its creation, the code has served as a resource principally to public health practitioners. as their respective disciplines would rightfully demand, the main reference for public health lawyers remains public health law and regulations; and the main reference for those trained in philosophy remains philosophical schools of thought. public health practitioners, however, have proceeded to build on the foundation of the code. although written under the auspices of the society of public health leadership, soon after it was completed in , the code was officially adopted by the apha and the national association of county and city health officials (naccho). naccho incorporated the code into its ethics training for local public health officials (naccho, ) . the code of ethics also became a resource for academic public health. in its report on education in public health, the iom included a section on public health ethics and mentioned the code (iom, ) . the report recommended the development of core competencies to guide the education of future public professionals. the association of schools and programs of public health (aspph) then developed core competencies for masters in public health degrees. the ethics competencies incorporated in leadership skills were informed by the code of ethics (e.g., "use collaborative methods for achieving organizational and community health goals") (aspph, ) . a few schools of public health have developed an oath of public health professionals that is read at graduation ceremonies. the oath of the university of georgia college of public health is modeled after the principles in the public health code of ethics (university of georgia, ). since the public health code of ethics was first drafted, a multitude of online platforms have been created that could help to further disseminate the public health code of ethics and host a community space for discussion on ethics in public health including twitter, which may be particularly suitable for connecting public health practitioners on the issue of ethics in public health. the american public health code of ethics is barely a dozen years old, but it has shaped the guiding principles of national public health organizations and is influencing the training of future public health professionals. as the teaching of public health ethics continues through degree programs and mechanisms, such as online modules and naccho's ethics training, the impact will continue to grow. even so, there are least three particular challenges to the growth in impact: . as previously mentioned, the ethical principles in the code are intended for organizations rather than individuals. while this accurately reflects the primary relationship between agencies and populations, which makes it difficult for individual practitioners to understand their role as stewards of the code. public health oaths, such as the one written by the university of georgia college of public health, may mitigate this limitation of the code. . public health is as much a consortium of constituent disciplines as it is a field unto itself. a person working at a water purification plant may identify more with the discipline of environmental science than with public health at large. this challenge is perhaps met in part by codes of ethics written by disciplines within public health, as noted above. we encourage those disciplines to reflect on the broader code of ethics as they write or revise their own, to ensure consistency and coverage of the full range of concerns to address. . the code has served as a resource primarily for public health practitioners. however, philosophers and lawyers are more likely to write text books on public health ethics. thus, the texts for teaching public health ethics may not appeal to future public health practitioners. we encourage public health practitioners who have one foot in academics, perhaps by being an adjunct professor, to develop ethics teaching resources that incorporate the processes of everyday life in various aspect of public health. this might include, for example, how decisions are made and communicated in the context of public health emergencies. the effectiveness of public health institutions depends heavily on the trust of the populations they serve. distrust results in passive and in some cases active resistance to policies and programs. a code of ethics reminds an institution of what it must do to maintain public trust. in the annual meeting of apha, the ethics section voted to update the code in light of its use and public health experiences since it was created. keeping the code up-to-date and relevant is an important step toward ensuring ethical practices that are worthy of public trust. see also: ethics and health promotion; ethics of immunization; ethics of infectious disease control. master's degree in public health core competency development project ethical and legal challenges posed by severe acute respiratory syndrome heroes of sars: professional roles and ethics of health care workers the future of the public health the future of public health education; ethics. national association of city and county health officials better late than never: a reexamination of ethical dilemmas in coping with severe acute respiratory syndrome ethics and sars: lessons from toronto ebola: the ethics of thinking ahead a code of ethics for public health genomics and public health ethics siracusa principles on the limitation and derogation provisions in the international covenant on civil and political rights the public health professional's oath ethical considerations in developing a public health response to pandemic influenza world health organization project on addressing ethical issues in pandemic influenza planning, draft paper for working group two: ethics of public health measures in response to pandemic influenza further reading public health ethics: the voices of practitioners the role of professional codes in regulating ethical conduct an ethics framework for public health ethics in health administration: a practical approach for decision makers skills in the ethical practice of public health science and social responsibility in public health aspx -european centre for disease prevention and control doc -national ethics advisory committee of new zealand. ethical values for planning for and responding to a pandemic in new zealand-a statement for discussion -public health code of ethics and accompanying documents pdf -university of toronto joint centre for bioethics. stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza key: cord- - x kfb authors: kieny, marie paule; bekedam, henk; dovlo, delanyo; fitzgerald, james; habicht, jarno; harrison, graham; kluge, hans; lin, vivian; menabde, natela; mirza, zafar; siddiqi, sameen; travis, phyllida title: strengthening health systems for universal health coverage and sustainable development date: - - journal: bull world health organ doi: . /blt. . sha: doc_id: cord_uid: x kfb nan the agenda for sustainable development is an opportunity for governments and the international community to renew their commitment to improving health as a central component of development. the accompanying sustainable development goals (sdgs) define the priority areas of action. goal (to ensure healthy lives and promote wellbeing for all at all ages), with target . on universal health coverage (uhc), emphasize the importance of all people and communities having access to quality health services without risking financial hardship. these health services include those targeting individuals, such as curative care and population-based services, such as health promotion. achieving uhc is an important objective for all countries to attain equitable and sustainable health outcomes and improve the well-being of individuals and communities. , health system strengthening is a means to progress towards uhc. a functioning health system is organized around the people, institutions and resources that are mandated to improve, maintain or restore the health of a given population. health system strengthening refers to significant and purposeful effort to improve the system's performance. strengthening is one way to ensure that the system's performance embodies the intermediary objectives of most national health policies, plans and strategiesquality, equity, efficiency, accountability, resilience and sustainability (box ). we argue that uhc contributes to the sdgs in several ways. the impact of health system strengthening on uhc, and how health system strengthening, through uhc, contributes to different sustainable development goals is illustrated in fig. . one way uhc contributes to the sdgs is by promoting global public health security and it does so by increasing the resilience of health systems to respond to health threats that spread within as well as across national borders. , the middle east respiratory syndrome coronavirus, the - ebola virus disease and zika virus outbreaks prompted the international community of the financial aftermath many countries faced as a result of protracted health emergencies. the impact of humanitarian and natural disasters is exacerbated by weak health systems. these recent outbreaks showed that resilience is an important feature of a health system and its effect on health workers' ability to adapt and effectively address complex challenges when responding to emergencies. resilience should be envisaged as a critical objective of contemporary health system reforms. when compared to resources spent on emergency responses, it is costefficient and in the long-term sustainable to invest in building resilient and functioning health systems. we claim that progress towards uhc will be essential to four specific sdg goals and the pledge to leave no one behind. first, as adults in poor health are more likely to be unemployed, when investments are made in improving health outcomes for the en-tire population, this can also contribute to sdg (end poverty in all its forms everywhere). in addition, implementation of social protection systems to address out-of-pocket health expenditure reduces the incidence of catastrophic or impoverishing household health spending. second, given that children and adolescents with good health have better educational outcomes, health has an important role to play in advancing sdg (ensure inclusive and equitable education and promote lifelong learning opportunities for all). third, as women comprise over % of the health workforce in many countries, the health system can contribute to advancing sdg (achieve gender equality and empower all women and girls). fourth, through the development of health systems that create fair, trustworthy and responsive social institutions, health system strengthening directly contributes to sdg (promote inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions for all). investments in the health sector to support uhc will boost economic growth in line with sdg (promote sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all). the who report from the high-level commission on health employment and economic growth states that the contribution to economic growth can happen through six inter-related pathways. health system strengthening marie paule kieny et al. the first pathway is through investment in health which contributes to an increase in life expectancy and healthier workers, contributing to increases in economic productivity. the lancet commission on investing in health reported that around one quarter of economic growth between and in low-and middle-income countries resulted from the value added by improvements in the health of the population. the estimated return on investment in health from improved economic growth was nine to one. the second pathway is through promoting economic output. the health sector adds direct economic value by expanding the number of jobs, investing in infrastructure projects and purchasing supplies needed for health-care delivery. a rapid and unprecedented growth in global health employment of around million new jobs, mostly in middle-and high-income countries, is expected by . this growth will happen against a backdrop of million unemployed people in . by , the number of unemployed may increase and because of technological advances from the fourth industrial revolution, it is expected that . million jobs will become redundant. given that occupations in the health and social sector are more labour intensive and less likely to be automated, the health sector will be an even more important source of employment in the future. third is through enhancing social protection. investing in decent jobs in the health sector contributes to enhancing social protection systems, for example in case of sickness, disability, unemployment and old age, as well as financial protection against loss of income, out-of-pocket payments and catastrophic health expenditures. social protection in turn, promotes sustainable pro-poor economic growth. the fourth pathway is linked to social cohesion. equal societies are more economically productive societies. fifth is through promoting innovation and diversification. the production and export of pharmaceuticals, equipment and medical services has been an important driver of economic growth in many countries. scientific and social innovations in this sector are likely to further support economic growth in the future. the sixth pathway is by protecting and promoting human security. strong health systems perform better in the detection, prevention and control of infectious disease outbreaks, protecting individual and global health security for peace, development, and economic growth. the expectation is that the health sector contribution to sdg , by protecting and promoting human security, will be significant. to deliver its potential, effective uhc development will require financ-ing and leadership. even in fragile states and least developed countries, domestic resources contribute to about % of total health spending. however, these domestic resources are often not equitably distributed either geographically or among various income quintiles, with out-of-pocket expenditures remaining unacceptably high. in many countries, a narrow fiscal space will not allow a sharp increase in domestic funding, but fig. . how health system sdg: sustainable development goal. a a health impact can be positive or negative. a positive impact is an effect which contributes to good health or improvement in health status. a negative impact causes or contributes to ill health. b action refers to interventions that aim at strengthening a health system. c whether people are healthy or not, is determined by their circumstances and environment. the determinants of health include the social and economic environment, the physical environment, and the person's individual characteristics and behaviours. health-care quality is the extent to which health services provided to individuals and patient populations improve desired health outcomes, consistent with current professional knowledge. equity in health is a measure of the degree to which health policies can fairly distribute wellbeing in the population. it can also refer to the absence of systematic or remediable differences in health status or access to health care. efficiency refers to the capacity to produce maximum output for a given input. accountability results from processes in the health system that ensure health-care actors a to take responsibility for what they are obliged to do and are answerable for their actions. health system resilience is the capacity of health-care actors, a institutions and populations to prepare for and respond to crises, maintain core functions in time of crisis; and, informed by lessons learnt during the crisis, reorganize if needed. sustainability refers to the potential for maintaining beneficial outcomes for an agreed period of time at an acceptable level of resource commitment. health system strengthening marie paule kieny et al. it is possible to critically examine and then recast how and where funding is allocated and expenditures incurred. to meet the health-related targets and make progress towards sustainable development, governments will need to use their domestic resources effectively, ensure people's interests are taken into consideration and that they have access to information and education. governments also need to prioritize health prevention and promotion measures. numerous challenges currently exist for governments to overcome. in many countries, funding is disease-oriented with limited coordination among partners and alignment with national health strategies and plans is poor. longterm sustainable investments in health systems have been neglected. additionally, there are rigidities in the production and allocation of professional roles, and vested interests in the management of the health services. the sdgs provide an opportunity to overcome these challenges and build political commitment to a common health system strengthening agenda. realizing progress towards uhc requires some level of guidance to promote a coherent and consolidated agenda for health system strengthening, which can be applied to country-specific uhc roadmaps. while countries pursue their ongoing national efforts to strengthen their health systems, the same effort is being reinforced at regional and global level. in september , the director-general of the world health organization announced the establishment of a global platform, the international health partnership for uhc , expanding the scope of ihp+ to include health system strengthening towards the achievement of uhc. ihp+ is a group of partners who work together to put international principles for development cooperation into practice in the health sector. the global platform aims to bring together development partners and governments, to improve coordination of health system strengthening efforts in countries, to facilitate multistakeholder policy dialogue, promote accountability and build political momentum around a shared and global vision of health system strengthening for uhc. towards integration at last? the sustainable development goals as a network of targets united nations the world health report. health systems: improving performance. geneva: world health organization arguing for universal health coverage. geneva: world health organization european ministerial conference on health systems health systems strengthening, universal health coverage, health security and resilience. bull world health organ rockville: agency for health care research and quality health system strengthening glossary what is a resilient health system? lessons from ebola health impact assessment. the determinants of health. geneva: world health organization vancouver statement for the fourth global symposium on health systems research one hundred fifty-eighth session of the executive committee health-system resilience: reflections on the ebola crisis in western africa geneva: world health organization working for health and growth: investing in the health workforce report of the high-level commission on health, employment and economic growth. geneva: world health organization global health : a world converging within a generation the future of jobs: employment, skills and workforce strategy for the fourth industrial revolution social protection, poverty reduction and pro-poor growth the price of inequality. london: penguin can innovative health financing policies increase access to mdg-related services? evidence from rwanda. health policy plan international health partnership for uhc . geneva: world health organization we thank maryam bigdeli.competing interests: none declared. key: cord- -tt dvhbd authors: liem, andrian; wang, cheng; wariyanti, yosa; latkin, carl a; hall, brian j title: the neglected health of international migrant workers in the covid- epidemic date: - - journal: the lancet psychiatry doi: . /s - ( ) - sha: doc_id: cord_uid: tt dvhbd nan compared with other international migrants (ie, international students), imws encounter more barriers in accessing health services in host countries (eg, inadequate health insurance), particularly migrant domestic workers. under normal conditions, imws have a high burden of common mental disorders (eg, depression) and a lower quality of life than local populations. , this situation could worsen during the covid- epidemic due to the potential and fear of governmental-imposed quarantine and lost income. for instance, some migrant domestic workers in hong kong and macau have lost their jobs because their employers have left the territory. many domestic workers cannot obtain masks from the pharmacy because they must stay with employers and adhere to government-recommended selfquarantine. in the absence of reliable information in their own language, imws may also not recognise the seriousness of the epidemic or receive accurate information on how to protect themselves from infection. however, most imws have smartphones, which can be a useful aid in providing informational and social support during the epidemic, like during the previous mers epidemic. for instance, wechat (a chinese social network platform) is used by imws in hong kong and macau for sharing key health messages and official information to the community and providing one another with emotional support. it can, however, also spread inaccurate information and panic that could lead to imws delaying visits to health centres due to stigmatisation of those who are infected. regardless of imws communities' self-reliance and resilience, addressing their health needs should be made an urgent public health priority because infection among these individuals could also lead to community infection, eventually affecting the entire population's health. for instance, during the epidemic, imws should be provided more accessible health care. public health campaigns should be available in multiple languages and diffused through various communication channels and networks of imws as soon as possible. in addition, more countries should ratify the international convention on the protection of the rights of all migrant workers and members of their families to provide global health equity and ensure that migrant workers' health is not neglected in future epidemics and disasters. who. novel coronavirus ( -ncov) situation report occupational health outcomes among international migrant workers: a systematic review and meta-analysis correlates of expected emental health uptake among filipino domestic workers in china we declare no competing interests. key: cord- -gmlsoo z authors: avilés-santa, m. larissa; monroig-rivera, alberto; soto-soto, alvin; lindberg, nangel m. title: current state of diabetes mellitus prevalence, awareness, treatment, and control in latin america: challenges and innovative solutions to improve health outcomes across the continent date: - - journal: curr diab rep doi: . /s - - - sha: doc_id: cord_uid: gmlsoo z purpose of review: latin america is the scenario of great inequalities where about million human beings live with diabetes. through this review, we aimed at describing the current state of the prevalence, awareness, treatment, and control of diabetes mellitus and completion of selected guidelines of care across latin america and identify opportunities to advance research that promotes better health outcomes. recent findings: the prevalence of diabetes mellitus has been consistently increasing across the region, with some variation: higher prevalence in mexico, haiti, and puerto rico and lower in colombia, ecuador, dominican republic, peru, and uruguay. prevalence assessment methods vary, and potentially underestimating the real number of persons with diabetes. diabetes unawareness varies widely, with up to % of persons with diabetes who do not know they may have the disease. glycemic, blood pressure, and ldl-c control and completion of guidelines to prevent microvascular complications are not consistently assessed across studies, and the achievement of control goals is suboptimal. on the other hand, multiple interventions, point-of-care/rapid assessment tools, and alternative models of health care delivery have been proposed and tested throughout latin america. summary: the prevalence of diabetes mellitus continues to rise across latin america, and the number of those with the disease may be underestimated. however, some local governments are embedding more comprehensive diabetes assessments in their local national surveys. clinicians and public health advocates in the region have proposed and initiated various multi-level interventions to address this enormous challenge in the region. within the last couple of decades, non-communicable diseases (ncds) have gained worldwide attention, especially in low-and middle-income countries (lmic), where they have been increasingly recognized and prevalent [ , ] . among the ncds, diabetes mellitus has become a global health challenge [ , , ] . type diabetes mellitus-the most common form of diabetes-due to its rather silent disruption may be a current uninvited companion to over million persons worldwide. in , it was estimated that the number of persons with diabetes in latin america (latam) was . million [ , ] and is predicted that by , the number will increase to . million, and to . million by [ ] . because of its multi-organ and multi-system impact, diabetes has been associated with both acute and long-term complications that affect not only health care needs and costs but also wellbeing and productivity [ , ] . within the last decade, it has also been recognized as one of the leading causes of death in some latam countries [ ] [ ] [ ] [ ] [ ] [ ] [ ] and an important risk factor this article is part of the topical collection on diabetes epidemiology for cardiovascular diseases (cvd), which is the leading cause of death in latam [ , ] . far from being a monolithic group, the latam population is highly heterogeneous, with various populations reflecting diverse genetic ancestry, ethnicity, culture of origin, sociopolitical contexts, environmental exposures, and beliefs and practices [ , ] . levels of inequality in latam remain among the highest in the world [ ] [ ] [ ] [ ] . all these factorscoupled with biological susceptibility, income, education, access health care, cultural influences on nutrition, health, selfimage, and self-care-influence the development of diabetes in latam. we conducted a review of the most current publications on the state of prevalence, awareness, treatment, and control of diabetes mellitus across latam. by laying out a detailed accounting of what is known, we aim to identify population, clinical, and health care needs, and opportunities for future research studies and potential interventions. we conducted the search using the pubmed electronic database as the primary scientific literature source. latam was defined as the countries in the western hemisphere which were previously colonized by spain, portugal, or france. a combination of keywords was used to define the scope of the searches: diabetes prevalence, awareness, treatment, control, guidelines of care, adherence, retinopathy, nephropathy, neuropathy, foot care, fundoscopic exam, and urine albumin, and searched under latam and by each individual country. hispanics/latinos living in the usa were not included in the search. we limited the search to publications since to reflect the most recent research on the prevalence of diabetes across latam countries, assessments of awareness, treatment, and control of diabetes (glycemic control), blood pressure and low-density lipoprotein cholesterol (ldl-c), and adherence to guidelines for care recommended by the american diabetes association (ada) [ ] [ ] [ ] and the latin american diabetes association (alad) [ ] , and specifically hemoglobin a c (hba c) measurement, fundoscopic exam, foot exam, and urine albumin excretion test. we included literature written in english, spanish, french, and portuguese. in addition to pubmed, when available, we manually searched each country's ministry of health and the pan american health organization (paho) websites and accessed published and downloadable national health surveys performed during the selected timeframe. since most available studies did not distinguish between type and type diabetes mellitus, our review is centered on diabetes mellitus (diabetes, henceforth) in general. because their specific mechanisms of disease and clinical implications, gestational diabetes mellitus, and type diabetes merit separate reviews. the earliest contemporary reports on the prevalence of diabetes mellitus among adults throughout latam date from the s and s [ ] [ ] [ ] , when most countries were beginning to experience epidemiologic transitions [ , ] . in , barceló reported an incidence of type diabetes in latam in the range . cases/ , in venezuela to . cases/ , in puerto rico [ ] . however, the authors highlighted a handful of reports on the prevalence of type diabetes and underlined the near absence of surveillance for the disease throughout the latam region [ ] . from to , the prevalence of diabetes mellitus across latam has been assessed within individual countries and through multinational studies and ranged between and . % (fig. , table ). in our review, some national surveys assessed the prevalence of diabetes via population representative samples [ , , , , - , , , , , , , , , , - , , , , , , ] and used similar population sampling methods (e.g., multi-stage, clustered, probabilistic sampling), whereas other studies focused on specific geographic regions or communities [ , , , , , - , - , , , - , , - , - , , - ] , recruited participants from clinical settings [ , , , , ] , or focused on specific age groups [ , , - , , , ] . also, the age range of the population surveyed-and consequently, age-adjustment estimates-varied among surveys. most of the studies (especially national surveys) reported the overall prevalence of diabetes without differentiating between type and type diabetes mellitus and many estimated the prevalence of the disease based on selfreport (being aware of having diabetes and/or taking antihyperglycemic medications) only. some national surveys and independent studies estimated the prevalence based on the sum of self-report and identifying individuals without history of diabetes but hyperglycemia within the diabetes range [ , ] . the latter group was considered to have "suspected," "undiagnosed," or "unknown" diabetes. hyperglycemia within the diabetes range was assessed by measuring fasting blood or plasma glucose (fbg or fpg) only, fbg/fpg and -h oral glucose tolerance test (ogtt), fbg/fpg and hemoglobin a c (hba c), hba c only, or the combination of fbg/fpg, ogtt, and hba c, or glucose levels in urine. some studies measured capillary blood glucose (cbg), while most studies measured venous blood or plasma glucose. while multiple studies used the ada/alad-recommended glucose/hba c cut points for the diagnosis of diabetes [ , ] , some studies used different thresholds (e.g., fasting glucose ≥ mg/dl (per cbg), random blood glucose ≥ mg/dl, or random blood glucose ≥ mg/dl). although the differences in the methodology described above limit the ability to perform cross-sectional or trend comparisons among countries, we note several commonalities. during - , some countries reported an increase in the prevalence of diabetes [ , , - , , - , , , ] , consistent with previously published reviews [ , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . compared with the rest of the region, and as previously reported [ , , , , ] , diabetes prevalence varies across the region, with higher prevalence in mexico ( . %), haiti ( . % in women and . % in men), and puerto rico ( . - . % in the population aged ≥ years and . % in the population aged ≥ years), and lower in colombia ( . % in the population aged ≥ years, but . % in age group ≥ years), dominican republic ( . %), ecuador ( . %), peru ( . %), and uruguay ( . - . %) (fig. , table ). multiple studies reported a greater prevalence of diabetes among women [ , , , , , , - , , , , , , , , , , , - , , , , , ] , and with increasing age, especially over age years [ , , , , , , - , , , , , , , ] . some studies reported an inverse relationship between diabetes and socioeconomic status (ses) [ , , ] or educational attainment [ , , , , , , , , , , , , ] . other studies reported a direct relationship between having health insurance and self-reported diabetes [ , , , ] , implying that persons who have health insurance-proxy of access to health care services-would be aware of their health issues and report them accordingly. this interaction also poses questions about not only the access to health care but also the timeliness and quality of the care, and health literacy (or the lack of) that persons in the lowest ses-and at the highest risk of diabetes-would experience. some studies reported a lower prevalence of diabetes among indigenous populations [ , , ] , with one study proposing that exposure to urbanicity was associated with an increased prevalence of diabetes among some indigenous communities [ ] . indeed, rural to urban migration (or living in rural compared with urban areas) has been associated with increased prevalence or risk of developing diabetes in peru [ , ] , and multiple countries reported a lower diabetes prevalence in rural compared with urban settings [ , , , , , - , , ] . the number of epidemiological studies published since indicates greater public health awareness about diabetes mellitus across latam. multiple countries have performed at least one national survey on chronic non-communicable diseases in which self-reported diabetes mellitus and/or elevated glycemia has been included (table ) . some surveys have also included at least one laboratory test (i.e., fasting or random blood glucose measurement or hba c), which could identify individuals at risk of developing diabetes or those who may have it and are not aware of it. because hyperglycemia may be mediated by at least two mechanisms of disease-increased hepatic glucose output manifested as fasting hyperglycemia and uncoupled postprandial insulin secretion manifested as postprandial hyperglycemia [ , ] -a single blood test or measurement may not identify all or most of individuals affected by the disease [ ] . therefore, the actual prevalence of diabetes may still be underestimated in many countries, as highlighted in previous reviews [ , , ] . the etiologies of diabetes mellitus are complex. thus, the increasing prevalence of diabetes experienced across latam may reflect the convergence or interaction of multiple factors [ , , ] . for instance, the increasing prevalence of overweight and obesity documented across latam has paralleled the increasing prevalence of diabetes in the region [ , , , ] . in addition to increased adiposity, type diabetes mellitus and insulin resistance have also been linked to malnutrition (at different life stages) in some lmics [ , [ ] [ ] [ ] . stress associated with chronic poverty, intergenerational poverty, natural disasters, and other adverse events [ , , , ] has been linked to chronic systemic inflammation and epigenetic changes, potential common denominators of multiple ncds [ , ] . many latam major cities may be epicenters where a fragile built environment and infrastructure and changes in lifestyle and nutrition intersect increasing the cumulative risk of developing diabetes in low-income communities [ , , , , , , ] . increased life expectancy has been associated with increased diabetes prevalence [ , , , , ] , whereas higher educational attainment, increased access to health care, and higher health literacy level are associated with increased awareness of the disease [ ] . these are all factors to consider upon designing comprehensive diabetes prevention and treatment strategies across latam countries. in addition, the growing prevalence of diabetes mellitus across latam and the complexity of the disease suggest opportunities to create or strengthen collaborations towards its prevention and early detection [ ] [ ] [ ] [ ] . for example, multinational and multidisciplinary researchpublic health-health care policy-clinical care partnerships which already exist in formal or informal platforms may be well-positioned to evaluate the impact of nutrition, health insurance, housing, and other public policies [ , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] on health outcomes and assess their potential translation into preventive strategies at the public health and clinical care levels. at the same time, the eventual implementation of such strategies will be strengthened by local governments' commitment to prioritize the prevention and treatment of ncds, in this case, diabetes, as previously voiced by experts and advocates in the region [ , , [ ] [ ] [ ] [ ] . diabetes awareness, treatment, and control although fewer than studies focused on prevalence, a considerable number of reports centered on diabetes awareness, treatment, and control across latam were published between and ( , ] . most studies did not use the term "diabetes awareness," but equated it (or more appropriately, diabetes unawareness) to "suspected," "undiagnosed," "unknown," or "new" diabetes or "elevated glycemia." "undiagnosed" diabetes-a proxy for lack of diabetes awareness-ranged widely from . to % across studies and countries ( table ). the prevalence of undiagnosed diabetes was higher in guatemala ( . %), uruguay ( . %), puerto rico ( . - %), honduras ( . - . % range), mexico ( . - % range), and nicaragua ( . %) and lower in colombia (bogota) ( . %), the southernmost countries of south america ( . %), and costa rica ( . - . %). irazola et al. [ ] described that diabetes awareness slightly increased with educational attainment. however, associations between undiagnosed diabetes with age, sex, educational attainment, ses, or geographic location were not published by most studies. the observed range of undiagnosed diabetes suggests that the actual prevalence of diabetes across latam could exceed previous estimates [ , ] and that a potentially significant proportion of persons with diabetes for whom both macroand microvascular complications may be present but not assessed and treated. therefore, current estimates of the prevalence of diabetes across continents may not fully account for the necessary resources to provide adequate health care for latin americans with diabetes [ , , , ] . considering the workforce and resources needed to screen the millions of persons across the region who are at risk of diabetes or have the disease and are not aware, experts have proposed diabetes predictive models requiring specific easily obtained clinical data points that could be readily used in primary care settings [ ] [ ] [ ] . also, the finnish diabetes risk score (findrisc) has been proposed, tested, or modified to screen and identify individuals at high risk of developing diabetes in latin america [ ] [ ] [ ] [ ] [ ] . point-of-care tests for hba c and urine microalbumin have also been proposed as alternatives to identify persons with "undiagnosed diabetes" and/or those at risk of chronic kidney disease (ckd) in low-resource and remote settings in latam [ ] [ ] [ ] [ ] . the standardization, reliability, and repeatability of some of these tests, as well as the clinical and public health benefit derived from their integration into the health care systems, may need to be determined [ ] . however, these and other emerging diagnostic technologies [ , ] are promising alternatives that could be incorporated to assess the prevalence of diabetes and implement timely interventions. the percent of persons with diabetes following any treatment for diabetes ranged from . to % across studies ( table ). prescription and/or use of antihyperglycemic medications was mostly assessed via interviews, although a few studies evaluated medical records. most individuals reported taking oral antihyperglycemic medications either as monotherapy or as a combination of oral medications, while a smaller percent reported using insulin alone or in combination with oral medications. five ( %) to . % only followed diet/exercise prescription [ , , , , , ] , and . to . % were not taking any medications [ , , , , ] . receiving or adhering to pharmacological treatment was positively associated with having health insurance [ ], and receiving medical care in private rather than public health care settings [ , ] . at least one study observed better pharmacologic treatment adherence with female sex [ ] . achievement of ada/alad-recommended glycemic goals [ , ] was assessed by multiple studies. the percentage of persons attaining hba c < % ranged from . to %. however, some studies defined glycemic control based on fasting or random blood glucose thresholds and reported attainment of glycemic control in the . to . % range. attainment of glycemic control was associated with higher socioeconomic status (ses) [ ] , having health insurance [ ] , and better access and services [ ] . not attaining glycemic control was associated with longer duration of diabetes [ , , ] , taking insulin (alone or in combination with oral antihyperglycemic medications) [ ] , forgetfulness (e.g., taking multiple medication for more than one condition) [ ] , complex therapeutic regimes [ ] , inadequate access to health care services [ ] , and availability or health insurance coverage of medications [ ] , among other factors. in addition to glycemic control, a smaller number of studies examined the attainment of ada/aladrecommended blood pressure and ldl-c-blood pressure < / mmhg and ldl-c < mg/dl-for patients with diabetes [ , ] . the percentage achieving blood pressure goals ranged from to %, and the percent achieving ldl-c goals ranged from to . % table ). the percent achieving optimal glycemic, blood pressure, and ldl-c levels altogether was reported by a handful of studies and up to . % ( table ) . the findings described above denote critical aspects of the state of diabetes care in latin america. the achievement of glycemic goals reported by the studies included in our review is similar to previously published studies [ , , , , ] . this implies seriously chronic and inadequate glycemic control at the population level across the region. the inclusion of questions on treatment for glycemic control, medical, and self-care in some national surveys increases our understanding of health-seeking behaviors, both patients' and clinicians' adherence to recommended guidelines of care, and challenges related to the utilization of health care services and availability of medications. the smaller number of studies reporting on the attainment of blood pressure and ldl-c goals and the proportion of patients achieving those goals also poses questions about the prevention of macrovascular complications in persons with diabetes in latin america, considering the raising prevalence of cvd in the region [ , ] . of note, most national surveys report prevalence and treatment and/or control of diabetes, hypertension, and blood cholesterol and the prevalence of tobacco use individually. since diabetes involves multiple organs and deserves a holistic care approach, reporting on the co-existence of other cv risk factors with diabetes would enhance critical understanding of cv risk and health care needs. also, some surveys collected biospecimens, but the test results were not included in the reports. it is possible that they are analyzed and published later. yet including test results in the surveys would offer a more comprehensive picture of the status of diabetes prevention and care needs [ , , ] to plan interventions accordingly. various studies included in our review reported on participants' receiving or following ada/alad-recommended guidelines of care [ ] for early detection and prevention of microvascular disease-annual fundoscopic exam, examination for peripheral neuropathy and comprehensive foot examination, annual function/urine albumin excretion testing, and hba c tested at least times per years [ - , , , , , , , , , , , , , , , , ] (table ) . some studies assessed the completion of several guidelines, whereas most studies focused on a few. the completion of the selected ada guidelines varied, ranging from . to . % for the foot exam, from . to % for the fundoscopic exam, and from . to . % for the urine albumin excretion test. most studies (especially national surveys) inquired about having hba c checked within the previous months. the affirmative response ranged from . to . %. in addition to inquiring about hba c testing, some surveys asked whether the participant's blood glucose had been tested (by a health care professional). having private health insurance was associated with a greater number of affirmative responses to the latter [ , , ] . despite the smaller number of studies evaluating the completion of the ada guidelines for foot care and prevention of microvascular disease, and the varied guideline completion rates previously described (table ) , the prevalence of long-term microvascular complications associated with diabetes has been documented across latam. for instance, in the studies included on our review and others published during the same time frame, the rate of foot ulcers ranged from . to . % [ , [ ] [ ] [ ] , and nontraumatic lower extremity amputations attributable to diabetes ranges from . to . % [ , , , , [ ] [ ] [ ] [ ] [ ] , and the prevalence of diabetic retinopathy ranged from . to % [ , , , , ] . ckd has become a major public health concern across central america [ ] [ ] [ ] , and the increasing prevalence of diabetes could exacerbate the incidence of ckd-and eventually end-stage renal disease and its associated health complications-in the region [ ] [ ] [ ] . the findings described above underline not just the urgent need to prevent diabetes but also to prevent complications among those with established disease, and the potentially underestimated burden on patients, societies, and health care systems across latam. in this regard, several innovative models of health care for patients with diabetes have been proposed and tested throughout latam. combining care of diabetes and other chronic conditions would be expected to maximize time and resources and improve health outcome. although combining diabetes and chronic pulmonary disease care did not demonstrate a difference in outcomes [ ] , this model could be revisited. also, interventions at the health care system element of the chronic care model might need to be adapted to the local health care system [ ] or synchronized with interventions at other levels. improvement of health care system structure and processes [ ] would assure timely access to patient information and enhance clinician decisionmaking. integrating social determinants of health into diabetes care demonstrated objective improvements in patient knowledge and cardiometabolic parameters [ ] . enhancing medical continuing education [ ] , an intervention combining diabetes prevention and self-management [ ] , co-creating interventions with community stakeholders and other countries [ , ] are other examples of alternatives to improve diabetes care throughout the region. another major regional example of efforts to implement better care for patients with [ ] , telehealth, mobile clinics, and other non-traditional health care delivery models. in addition, a non-exhaustive list of examples of past or current interventions, policies, and initiatives is provided in table [ , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . interventions in the list include tele-ophthalmology [ , , , ] , teambased foot self-care education [ ] , diabetic retinopathy education and screening at a community pharmacy [ ] , rapid assessment/diagnostic tools to screen for or detect retinopathy, nephropathy, and risk of developing foot ulcers [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] and are examples of clinical research and/or implementation activities designed to strengthen the prevention and early detection of diabetes-associated complications and improve health outcomes throughout latam. many interventions on diabetes care have focused on patients and/or clinicians as the primary recipients or enablers of the interventions. because of the complex nature of the disease and the multiple factors that mediate treatment effectiveness, interventions involving other levels or elements within the health care organization or system [ , , , [ ] [ ] [ ] or the health care workforce [ , , ] could be considered. interventions involving other sectors (e.g., housing, infrastructure, national or local policies) could uncover very valuable and needed strategies to enhance treatment effectiveness and potentially reduce health care costs in the long-term. the feasibility and sustainability of such research efforts-and subsequent policies-would need to be demonstrated and supported locally [ ] . multiple studies in our review reported a higher prevalence of diabetes among women [ , , , , , , - , , , , , , , , , , , - , , , , , ] . while the mediating factors for this sex difference need further study (e.g., history of gdm, which was outside of the scope of this review), the increased prevalence of diabetes among women in some latam countries would be expected to have implications for health and health care, and potentially future generations [ ] [ ] [ ] . since diabetes may increase women's risk for cvd, including stroke [ ] , cognitive decline [ , ] , or some cancers [ , ] , timely and comprehensive preventive care for women of all ages would need to be prioritized. due to the epidemiologic transition already experienced by some countries throughout latam, the population pyramid is also shifting towards a greater proportion of older adults. studies included in our review consistently reported an increased prevalence of diabetes with age. diabetes care challenges specific to this age group include risk of obesity or undernutrition [ , ] , increased risk for disability [ ] , economic barriers to appropriate access to health care [ ] , disruption in funding of health insurance [ ] , disparate completion of diabetes care guidelines based on health insurance coverage [ ] , inequalities in access to and utilization of health care services [ ] [ ] [ ] , complex medical care needs and frailty [ ] , cultural beliefs, mental health, and lack of family or social support [ ] , among others. prevention of diabetes and its complications and reliable continuity of care and social support [ ] need to be especially tailored for this population across the region. a few studies in our review reported a low prevalence of diabetes among some indigenous populations in latam [ , , ] , in parallel to some previous reports [ ] [ ] [ ] [ ] about other indigenous groups in the region and in contrast with the higher prevalence of diabetes among american indians in the usa [ ] and the first nations in canada [ ] . however, other studies in our review and in the current literature have documented elevated diabetes prevalence or risk among indigenous and other socioeconomically disadvantaged ethnic groups [ , , , , , , , , , [ ] [ ] [ ] [ ] [ ] . some of the diabetes prevalence studies included in our review focused on or mentioned participants from indigenous groups [ , , , , ] and other underrepresented groups (e.g., garifuna, afro-panamanian, afro-peruvian, afro-ecuadorian) [ , , , , ] . however, a few studies have evaluated diabetes care, prevalence, and/or prevention of macro-or microvascular complications, diabetes management interventions, other health care needs and access to health care among indigenous populations [ , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , and none on the other groups (that we could identify through our search). understanding the protective mechanisms (e.g., biochemical, immune, epigenetic) against diabetes experienced by some indigenous populations would be relevant to millions at high risk of developing diabetes. at the same time, the increased prevalence of the metabolic syndrome and diabetes experienced by some indigenous groups and other ethnic groups may increase their risk not only for cvd and other diabetes long-term complications but also for re-emerging [ ] - mexico, honduras interactive voice response (ivr) support calls for chronic disease management for spanish speakers-the investigators report cumulative findings in honduras, mexico, and spanish-speakers in the u.s. involvement of caregivers enhanced engagement. by self-report, there was improved medication adherence and self-management was similar across sites. piette, [ ] honduras cloud-computing model -the investigators tested a mobile phone-based intervention of weekly voip calls and ivr with patients with diabetes and automated emails to clinicians and voicemail reports to family caregivers for six weeks. improved self-care and diabetes management and significant improvement in glycemic control were reported. piette, [ ] bolivia structured caregiver feedback -the investigators assessed whether automated telephone feedback to caregivers ("carepartners") increased engagement in mobile-health support among patients with diabetes and hypertension in bolivia. significantly greater engagement was observed. patients who spoke indigenous languages at home were more than x as likely to complete the ivr calls. piette, [ ] bolivia mobile health program for chronic disease self-management in bolivia -assessment and implementation of ivr for weeks. it was associated with improved medication adherence, self-reported health status, and satisfaction. prestes, [ ] - argentina diapremintegrated diabetes care program including systemic changes education, registry and disease management flood, [ ] guatemala implementation and outcomes of a comprehensive type diabetes program in rural guatemala through a non-government organization and involving nurse-directed care flood, [ ] rural guatemala implementation of a multi-level quality improvement program for ambulatory diabetes care based on input from patients and other stakeholders flood, [ ] - rural guatemala home-based type diabetes self-managementintervention delivered by diabetes educator at home and synchronized with clinic follow-up. mayan communities tapia-conyer, [ ] gallardo-rincón, [ ] to present mexico casalud model -is a comprehensive primary health care model implemented in mexico that enables proactive prevention and disease management using innovative technologies and a patient-centered approach. the program was pilot tested in and implemented nationwide in . infectious diseases, like tuberculosis [ ] [ ] [ ] . therefore, disease prevention and health care models that account and reach these populations need to be considered. through this review, we have highlighted the most current reports on prevalence, awareness, treatment, control, and adherence to recommended guidelines of care for diabetes mellitus across latam published from to . during that time frame, a considerable number of surveys assessing the prevalence of the disease and an increasing body of reports on the achievement of treatment and care goals were identified. such reports demonstrate the imperative need to garner a more comprehensive understanding of the extent of diabetes across countries, and both past and ongoing efforts to establish effective and sustainable models of prevention and high-quality care able to reach and serve all peoples across the region. during the writing of this manuscript, latin america had been recognized as the new epicenter of the sars-cov- (covid- ) pandemic [ ] . the effects of the disease in persons with diabetes in the region are beginning to be uncovered [ ] [ ] [ ] , while some solutions are proposed [ , ] . the magnitude of the impact of the pandemic on the health and health care needs of persons with diabetes mellitus and other ncds-let alone on the health care systems infrastructures-in the region are yet to be known. the task ahead is substantial and will require multidisciplinary and cross-sectoral strategies and collaborations to reduce diabetes burden and improve health outcomes across latin america. acknowledgments the authors would like to thank ms. jill pope (kaiser permanente center for health research) for her valuable review of the manuscript and the ponce health sciences university for creating the opportunity for am-r and as-s to work in this review. understanding the rise of cardiometabolic diseases in low-and middle-income countries global burden of diabetes, - : prevalence, numerical estimates, and 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study protocol for a randomized controlled trial human resources for health in peru: recent trends ( - ) in the labour market for physicians, nurses and midwives barriers in household access to medicines for chronic conditions in three latin american countries a systematic review of innovative diabetes care models in low-and middle-income countries (lmics). j health care poor underserved the quality of primary care services, vocational training and the more doctors program in a health region of southwest goiás viva la familia study: genetic and environmental contributions to childhood obesity and its comorbidities in the hispanic population exposure to gestational diabetes enriches immune related pathways in the transcriptome and methylome of human amniocytes burden of disease in latin america cardiovascular disease in latin american women diabdem project: a pilot study of prevalence of cognitive impairment in diabetes mellitus in hispanic countries predictors of optimal cognitive 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access to diabetes care among the indigenous population: perspectives of individuals living in rural guatemala the first national survey of indigenous people's health and nutrition in brazil: rationale, methodology, and overview of results health system and aboriginal communities in the province of formosa diabetes, undernutrition, migration and indigenous communities: tuberculosis in chiapas prevalence of comorbidity tuberculosis and diabetes mellitus in paraguay, and prevalência de comorbidade tuberculose-diabetes mellitus no paraguai co-management of tuberculosis and diabetes: an integrative reviewmanejo integrado de la tuberculosis y la diabetes: revisión integrativa covid- in latin america the impact of covid- on people with diabetes in brazil unequal impact of structural health determinants and comorbidity on covid- severity and lethality in older mexican adults: considerations beyond chronological aging covid- impact on people with diabetes in south and central america (saca region) critical review of social, environmental and health risk factors in the mexican indigenous population and their capacity to respond to the covid- covid- pandemic triggers telemedicine regulation and intensifies diabetes management technology adoption in brazil publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- - lppl x authors: banjar, weam m.; alqeel, meshal k. title: healthcare worker's mental health dilemma during covid- pandemic: a reflection on the ksa experience date: - - journal: j taibah univ med sci doi: . /j.jtumed. . . sha: doc_id: cord_uid: lppl x nan all reported cases were associated with wuhan's seafood market. laboratory investigations indicated that the reported pneumonia was caused by a novel coronavirus. the international committee on taxonomy of viruses (ictv) named the novel coronavirus, severe acute respiratory syndrome coronavirus (sars-cov- ). the who subsequently named the disease caused by the coronavirus, 'covid q - '. , as the number of covid- cases in china and internationally increased, the who held an emergency meeting on january , declaring the covid- outbreak a public health emergency of global concern. , as of june , the number of internationally reported cases reached , , , with a . % recovery rate and a less than % mortality rate. by then, the largest number of cases had been reported in the united states of america (usa); , , , with a % recovery rate and a % mortality rate. in the eastern mediterranean region, the largest number of cases were reported in the islamic republic of iran, followed by ksa. in iran, , cases were reported, with a recovery rate of . % and a mortality rate of . %. in ksa, , cases were reported, with a recovery rate of . % and a less than % mortality rate. , the exponential increase in covid- cases in china caused stress and anxiety among healthcare workers (hcws). an estimated hcws were diagnosed with covid- , and deaths were reported. in ksa, the exact number of covid- cases among hcws has not been publicly disclosed. however, several regional health directorates issued mourning statements to honour the deceased hcws. frontline hcws have been under intense strain since the beginning of the quarantine. the pressure on hcws continued to rise, and a perceived lack of influence on decision-making increases tensions. frontline hcws face multiple challenges. a sudden epidemic outbreak leads to an unexpected increase in workload, rising occupational exposure to violence, and the risk of contracting covid- . supply chain failures jeopardise the availability of personal protective equipment (ppe). however, while hcws accept the higher risk of infection as part of their profession, they are concerned about the risk of transmission to their families. hcws might suffer from comorbidities that put them at a higher risk of infection and mortality. hcws performance may be influenced by feelings of uncertainty, increased psychological pressure, and the risk of stigma. frontline hcws psychological response to an increasing workload and stress is fundamental to maintaining the healthcare system's operational efficiency. due to direct exposure to infected patients, and the demanding nature of their duties, frontline hcws are at higher risk of developing mental health problems than those indirectly involved in managing the pandemic, and they may need psychological intervention. , , reports of mental health problems caused by covid- among hcws are increasing. in response, there were calls for comprehensive measures to promote mental health support. on may , the un secretary-general launched the covid- and mental health policy brief, which encouraged governments, civil jtumed _proof ■ july ■ / societies, and health authorities to draw up a plan to mitigate mental health problems among hcws. 'mental health services are an essential part of government response to covid- ', the un secretary-general stated. ksa has adopted a multidimensional, multisector disaster management plan to mitigate the impact of the covid- pandemic on the healthcare system and the population. the aim is to reduce the disease's economic and social burden. to combat the covid- pandemic and protect the public welfare, ksa implemented drastic preventive measures. these include travel restrictions on all domestic and international flights, the lockdown of cities, total or partial curfews (depending on epidemic status), and the closing of mosques, shopping malls, and recreation centres. mass events were cancelled, and work was suspended. a virtual operational mode was implemented at all governmental agencies. as the epidemic curve escalated, the anxiety and tension grew among frontline hcws. healthcare facilities quickly realised that demanding professional duty in a challenging work atmosphere with an increasing workload would undermine the mental health of frontline hcws, and mandated the establishment of mental health support programs. on march , , the custodian of the two holy mosques, the king of ksa, addressed the residents of ksa and delivered a message of solidarity between the leadership and citizens. the king's speech honoured the efforts of hcws and health officials and assured the population that government agencies make every effort to maintain their safety and public services. ministerial messages expressed appreciation for the efforts of frontline hcws. the term 'heroes of health' has become a registered trademark of the covid- era, demonstrating leadership and gratitude for hcws and health services. institutionalised initiatives to meet the increasing demands for psychological support among hcws focused on four domains; education, therapy, awareness, and prevention. the ministry of health, in collaboration with the private health sector, academic institutions, and providers of health services to government, launched a national awareness campaign. the focus was on the population's psychological needs during the pandemic and its impact on mental health. special attention was paid to raising the level of awareness among hcws of the psychological burden of serving during the pandemic. various institutions and professional societies organized educational webinars to introduce mental health professionals, occupational health specialists, and hospital administrators to the fundamentals of mental healthcare. psychiatrists, psychologists, and social workers needed to be equipped with the tools to assess mental health and deliver the appropriate care. the ministry of health designated a hotline to support hcws and address their concerns. academic institutions and military hospitals established a wellness program for employees whose primary focus is on mental health. the program provides options for care in clinical settings or telemental health services. specialized clinics were designated for employees to meet the increasing demand for mental care and prevent burnout or mental breakdown. telemental health services enable employees to voice their concerns and receive the necessary support and referral if required. the reluctance of hcws to utilize wellness services led to the establishment of an anonymous online support group where hcws could share their reservations. wellness programs helped hospital administrators to improve the work atmosphere and establish a culture of embrace. the saudi commission for health specialties (scfhs) launched the 'imtinan' (gratitude) initiative. the 'imtinan' aims to express the leadership and society's appreciation for the efforts of hcws. frontline hcws received a personal phone call from the scfhs general-secretary thanking them for their efforts and contributions. the scfhs temporarily extended professional registration for all hcws. the risk of licenses being suspended was thus eliminated. over , hcws have benefited from the temporary extension of registration. free-access to the webinar platform was granted to all hcws to ensure the delivery of updated information. the scfhs also launched the second phase of the 'da'em' (supporter) program. the da'em is a -hour web-based wellness program that provides psychological support to hcws across the kingdom and to saudi health trainees abroad. the program aims to reduce the psychological burden of covid- . the covid- pandemic sheds light on the fragility of mental resilience and the need for a national mental health intervention plan. in collaboration with public health experts and population health researchers, mental health professionals have to conduct epidemiological research that provides the structure for a national wellness program, with the focus on occupational mental health. furthermore, the research findings should inform the national response plan for public health protection and amend the mental health protection chapter. identifying needs and demands and addressing problems is at the heart of a targeted mental health intervention. to maintain the mental health wellness program's effectiveness, periodic review and continuous monitoring are essential for evaluation, improvement, and correction. wellness initiatives launched in response to the covid- pandemic in ksa could serve as a prototype for a national program. experienced evaluation is pivotal to complementing strengths and identify shortcomings. it is important to protect the mental health of hcws to ensure the safety, efficiency, and effectiveness of health services. administrators need to realise that feelings of inadequacy are understandable. a non-judgmental approach is necessary to maintain the mental health integrity of hcws. transparent and thoughtful communication will contribute to trust and a sense of control. by holding regular discussions and stand-up meetings with frontline hcws, the professional bond between them and the facility would be strengthened, and it will assure that administrators are considerate and appreciative. open communication channels are needed to resolve concerns and conflicts. when the pandemic has passed, there will be an open dialogue with all relevant stakeholders about staffing, secure resources, and a safe, modern system of care. the involvement of mental health professionals in developing human capital planning and the design of occupational health programs are essential to maximise wellness programs' effectiveness. a review of the national disaster management plan should consider targeted mental health intervention as a mandatory chapter. it should ensure the safety of the population safety and the continuity of service delivery. coronavirus diseases- (covid- ) situation reports psychological symptoms among frontline healthcare workers during covid- outbreak in wuhan general hospital a review of the novel coronavirus (covid- ) based on current evidence naming the coronavirus diseases (covid- ) and the virus that causes it, who technical guidance factors associated with mental health outcomes among health care workers exposed to coronavirus disease covid- daily updates supporting the healthcare workforce during covid- global epidemic looking after doctors' mental wellbeing during the covid- pandemic psychological impact of coronavirus disease (covid- ) outbreak on healthcare workers in china mental health strategies to combat the psychological impact of covid- beyond paranoia and panic a systematic review of the impact of disaster on the mental health of medical responders healthcare worker's mental health dilemma during covid- pandemic: a reflection on the ksa experience this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. this to confirm that this editorial had been prepared in accordance to cope roles and regulation. given the nature of the editorial, irb review is not required. key: cord- - t ao e authors: byrne, peter; james, adrian title: placing poverty-inequality at the centre of psychiatry date: - - journal: bjpsych bulletin doi: . /bjb. . sha: doc_id: cord_uid: t ao e we examine epidemiological evidence for the central role of inequalities (principally economic) in driving the onset of mental disorders, physical ill health and premature mortality. we locate the search for solutions in current uk contexts, and include known and likely effects of the covid- pandemic. prevention of mental disorders and adverse outcomes such as premature mortality must begin with efforts to mitigate rising poverty-inequality. where do we start with prevention? many would begin with adverse childhood experiences (aces). the original concept arose from a prospective study of childhood obesity, but their wider predictive value merits study. hughes et al demonstrate increased relative risks in adults with four or more aces: doubled risks of heart disease ( % ci . - . ), alcohol misuse ( . - . ), and cancer ( . - . ); tripled rates of chest diseases ( . - . ) and anxiety ( . - . ); a four-fold increase in 'low life satisfaction' ( . - . ) and depression ( . - . ); and a -fold increased risk of a suicide attempt ( . - . ) . for selective or targeted prevention, we look at the other end of the (shorter) life of someone with severe mental illness (smi); we might start with smoking, obesity, alcohol and substance misuse. all four shorten life expectancy and healthy years expectancy (life before multimorbidity begins) and make our task of improving quality of life in smi even harder. then there is a sixth area, fair access to medical care: current national strategies to improve physical health outcomes in people with smi and treatment of all mental disorders focus on this. older citizens, who began life as 'baby boomers', have acquired the nastier metaphor of a 'ticking time bomb' in terms of likely health and social care costs. the prevention of many dementias (vascular dementia, alcohol-related brain damage, head injury) is achievable. seven challenges then, maybe for seven royal college of psychiatrists-led intercollegiate committees? no, there is a better way. behind all seven of these, michael marmot's 'causes of the causes', prevention has one major focus: poverty-inequality. what are the consequences of poverty-inequality? 'inequality exists in the stresses and strains on family life, which shape the environment in which children grow up. it is the divergence in life expectancy between deprived and affluent areas, and the growing burden of poor mental health among disadvantaged groups'. in his accessible book, the health gap, marmot concludes that 'the (health) gradient involves everyone, rich, poor and in between' (p. ). poverty is not inevitable, and 'in the us, after transfers and taxes, child poverty is higher than lithuania - % compared with %despite having similar levels of poverty pre-tax' (p. ). life expectancy, and specifically why this is falling in the uk (and was falling before covid- ) among older and poorer citizens, is key to understanding why we need fundamental change. marteau and colleagues studied the uk government's ambitions to reverse this rising mortality: 'the leading causes of years of life lost in england are tobacco use, unhealthy diet, alcohol consumption, and physical inactivity. all of these behaviours are socioeconomically patterned'. the scientific literature has reached a consensus on the health harms of poverty-inequality. in their study of multimorbidity in the ethnically diverse london borough of lambeth (where a third of a million are registered with a general practitioner (gp)), ashworth et al concluded that: 'acquisition of multimorbidity is patterned by socioeconomic determinants', with depression and asthma as early drivers of poor physical health. the us and the uk have similar high levels of inequality, and their inhabitants can expect to lose - healthy years (free from physical disability) by the age of if they are poor, compared with their fellow citizens at the least deprived end of the gradient. all the evidence points to poor mental health, from common mental disorders through to smi, as the means whereby poverty wrecks physical health. yes, they do. but they get better from depressive episodes faster and relapse less, in contrast to people on lower incomes, who have higher prevalence rates and worse outcomes. we also concede that most people who grow up in poverty do not develop a life-changing episode of depression, let alone smi. but the antecedents of smi are complex, and our understanding of why people develop psychosis is changing, building on the seminal work of jim van os on the toxic effects of urbanicity with consistent evidence of the cumulative effects of social disadvantage. work with case-control groups in south london showed odds ratios (ors) for subsequent psychosis in people below the poverty line of . ( % ci . - . ) and . ( . - . ), for -year and -year pre-symptom onset, respectively. these ors were the single highest predictors of psychosis, other than the related but confounded or of . ( . - . ) for being unemployed on presentation to psychiatric services. outcomes in adults with first-episode psychosis are complex and improving slowly in our professional lifetimes (with adequately resourced early intervention services); even at -year follow-up, mattsson et al showed financial strain and social networks to be strong, independent predictors of outcomes. we cannot ignore poverty as a predisposing, precipitating and maintaining factor in most of our patients' disorders. early in the neuroleptic era, we knew that poorer people had worse outcomes in schizophrenia, stayed in hospital longer, and were socially isolated even if they achieved discharge, but our textbooks called this 'social drift' despite prior debunking of the drift hypothesis. hindsight is easy, certainly, but perhaps we should look to psychiatry's institutional bias. we still speak of a problem of stigma (negative societal attitudes) rather than acknowledging the reality that people with smi have lower status conferred on them and face institutional obstacles to achieving their life goals, and calling this out as subcitizenship. at the time we started writing this, we welcomed the stated intention of the uk government to reverse a decade of austerity, signalled first in october and often repeated during the first weeks of the spring lockdown. in advocating a broader role for busy psychiatrists in opposing regressive social policies, we are echoing the 'wake-up call' to colleagues from : '[it is] fully consistent . . . to think of psychiatry as being the only specialty in which its practitioners are fully trained doctors, incorporating psychology and socialbased knowledge and skills as major components of training'. not 'social workers with stethoscopes' but clinicians with public health knowledge who understand the environments in which our patients live. and die. what we know about the effects of covid- (so far) covid- has changed how every health professional practises. each health specialty must play its part in mitigating and preventing further adverse outcomes. the virus leaves a trail of delirium, depression and anxiety, perhaps posttraumatic stress disorder in those who survive, and further misery for those bereaved. covid- has revealed and exacerbated inequalities. examination of death rates in the first hospital deaths with proven covid- in england and wales shows major differences between the richest and poorest regions: 'people living in more deprived areas [for example, the london boroughs of newham and brent, in the context of an early first peak in london] have experienced covid- mortality rates more than double those living in less deprived areas. general mortality rates are normally higher in more deprived areas, but so far covid- appears to be taking them higher still'. at the time of writing, recording of the proportions of deaths among black, asian and minority ethnic (bame) groups was incomplete, but preliminary figures, not least those for deaths among our bame colleagues working in health and social care, have shown an excess. health gradient differences are among the lessons of the pandemic: the age-standardised mortality rate of deaths involving covid- in the most deprived areas across england was . deaths per population, compared with . deaths per population in the least deprived areas. we have yet to learn the full extent of excess deaths from covid- among our patients across age groups, regions and specialties. it is too late for them, but we will not dodge the hard questions. as mental health professionals, we cannot remain as observers; we must now act on poverty-inequality. this issue opens with a contribution from two people with lived experience of smi. smoking remains a challenge in mental health services, and you will read about tobacco poverty and how to achieve more 'quits'. housing first shows the evidence for changing how we approach this issue. we feature the glasgow perspective on how we might progress, as well as an article on the cruelty of 'reforms' to the safety net benefits system. there is a biomedical perspective too. to name just five areas, we have not raised here the related premature mortality of people with personality disorders and intellectual disabilities, often worse even than that in people with smi, nor the excellent work by patients, carers and professionals to reduce high-dose prescribing of psychoactive medications in intellectual disability. health inequalities drive the uk's obesogenic environment, which is relevant to premature mortality in general but specifically to covid- deaths. cuts to addictions services are considered elsewhere, alongside the opioid crisis that has crossed the atlantic. as we mature as clinicians, our goals of intervention adjust to realities and hard-won experience. we do not see patients as a collection of neuroreceptors (including subtype and putative phenotype); we devise complex formulations to persuade patients towards self-management and empowerment, consolidating their (real not virtual) social networks and support systems. to achieve this, we will need to practise psychosocial education. communicating complex information about the drivers of mental disorders might be easier if our patient has just one, but aetiology (causes of the causes) is shared. beyond your wards and clinics, other health professionals also need to know what we know. do our gp letters communicate the individual drivers of someone's misery (inadequate housing, precarious income, indeterminate status to remain, no locally available stop smoking services, the pressures of raising children when a parent has mental health or substance issues, etc.), or is it easier to write about medications and risk? it is a great start to identify what we can do better where we work , and we cannot dispense social prescribing unless we understand our local communities. do you know who leads on inequalities in your local organisations? are there aspects of your practice where inequalities are making outcomes worse, and are you in a position to influence mitigation for these? regional structures and local alliances have the potential to achieve results beyond the ephemeral 'levelling up' of current public discourse. of course there will be political voices (of all shades and volumes) to keep us quiet, but we are 'following the science'. the royal college of psychiatrists has joined with many partners in equally well (www.equallywell.co.uk) to use the available evidence to reverse rising smi mortality. we hope this special issue of the bjpsych bulletin will get people thinking and talking. what will you do to achieve a wider societal dialogue? our college and others are building resources to tackle poverty-inequality, but we need all the help we can get. disease burden and government spending on mental, neurological, and substance use disorders, and self-harm: cross-sectional, ecological study of health system response in the 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role of health professionals key: cord- - e akcjf authors: liu, peilong; guo, yan; qian, xu; tang, shenglan; li, zhihui; chen, lincoln title: china's distinctive engagement in global health date: - - journal: lancet doi: . /s - ( ) -x sha: doc_id: cord_uid: e akcjf china has made rapid progress in four key domains of global health. china's health aid deploys medical teams, constructs facilities, donates drugs and equipment, trains personnel, and supports malaria control mainly in africa and asia. prompted by the severe acute respiratory syndrome (sars) outbreak in , china has prioritised the control of cross-border transmission of infectious diseases and other health-related risks. in governance, china has joined un and related international bodies and has begun to contribute to pooled multilateral funds. china is both a knowledge producer and sharer, offering lessons based on its health accomplishments, traditional chinese medicine, and research and development investment in drug discovery. global health capacity is being developed in medical universities in china, which also train foreign medical students. china's approach to global health is distinctive; different from other countries; and based on its unique history, comparative strength, and policies driven by several governmental ministries. the scope and depth of china's global engagement are likely to grow and reshape the contours of global health. in only three decades, china's global engagement has accelerated from closed autarky to open engagement; from relative isolation to integration into the world system; from a low-income to a middle-income country; and from an aid recipient to an aid donor. as a global demographic and economic giant, china's prominence in global health should not be surprising. with % of the world's population, china weighs heavily in all global health metrics, such as life expectancy, disease burden, and health systems. as the world's largest trading nation, its movement of goods and services is associated with transfer of health technologies, diseases, and risk factors. in health knowledge and strategies, china has a rich history of traditional medicine and has pioneered many health-care innovations. china's ascendency has generated many questions and some concerns. a common assumption is that china uses foreign aid to secure energy and natural resources and to expand export markets. , china's claim of aid with "no strings attached", is considered by some to encourage corruption, weaken accountability, or ignore human rights. the international press has reported delayed and muddled notifi cation of infectious outbreaks, and much news of exported contaminated chinese manufactured products. china is sometimes perceived as working alone and insuffi ciently cooperating with other countries. in this review, we attempt to address the following questions: what is china's role in global health? is china's engagement distinctive or similar to other countries? what does the evidence illuminate of china's global health engagement? china, similar to most countries, has no single offi cial source of data for global health because of the multiplicity of governmental stakeholders, the absence of a national strategy on global health, and the unclear borderline between aid and trade investments. a study by nyu's wagner school has estimated china's foreign aid to africa, latin america, and southeast asia from to . strange and coauthors estimated all previous estimates of chinese development fi nance to africa. the state council of the chinese government, the highest body of state administration, published white papers summ arising china's overall foreign aid in and . none of the above estimations disaggregated or separately reported health aid. , we thus have resorted to an extensive search of data from multiple chinese sources-the state council, the ministries of health, commerce, education, foreign aff airs, and science and technology. reports from provincial governments, chinese embassies abroad, and the press were searched. altogether, we obtained data from sources- from various websites, from statistical yearbooks, from regular reports, and from newspapers. data sourced came from groups of organisations, including sources from the ministry of commerce, from the health ministry (national health and family planning commission), and from ministry of education. the overwhelming proportion of these data sources are in chinese ( %), with less than % in english. all data sources are shown in the appendix. interviews were done with dozens of former offi cials, medical team members, and key provincial authorities to collect fi rst-hand information. not surprisingly, the data quality is mixed, often incomplete, and the fragments need to be matched and fi tted together. the chinese government is essentially the only source of information, without other sources of independent verifi cation. reports of classifi cation and nomenclature often do not follow international standards. a common limitation is the mixing of stock data versus fl ow data. our compiled data, nevertheless, generate what we believe to be the most robust estimation possible. matching and piecing together the fragments allows inconsistencies to be double checked for consistency. most inconsistencies relate to exact numbers, but estimation of the general order of magnitude is believed to be reasonably robust. all data sources for this review are shown in the appendix in both original chinese and translated english. after introducing a framework, we present sections on china's work in health aid, health security, health governance, and knowledge exchange. china's participation in global health has deep historical roots, not only just in recent years. in the fi rst millennium, knowledge of medical cures were transmitted by the silk road that facilitated exchange between china, india, the middle east, and europe. in the th century, some chinese health crises such as the manchurian plague epidemic captured the attention of neighbouring countries of the international community. china has historically been the origin of many infectious epidemics and a source of key health innovations of breakthroughs such as the barefoot doctor (a term that emerged in the s and s, which refers to farmers who received minimal basic medical and paramedical training and worked in rural china to promote basic hygiene, preventive health care, family planning, and treat common illnesses. the name comes from southern farmers, who would often work barefoot in the rice paddies), and artemisinin, an eff ective antimalaria drug developed from plant-based chinese traditional medicine. , because there is no universal consensus for the defi nition of global health, some approaches focus on transnational health risks, which lie beyond the reach of national governments, whereas other approaches stress the global commitment and responsibility to address health inequities and to support health. we have adopted a framework of global health as characterised by health and related transnational fl ows of diseases, people, money, knowledge, technologies, and ethical values. [ ] [ ] [ ] four domains capture these globalisation processes (fi gure ). first, health aid aims to advance global health equity. it is the traditional area of offi cial development assistance (oda) coordinated by organisation for economic cooperation and development (oecd) countries. second, global health security should be ensured by management of interdependence in global health and mutual protection against shared and transferred risks, such as epidemic diseases. third, health governance is needed for global stewardship to set ground rules as mediated by health diplomacy. fourth, knowledge exchange is needed, which includes the sharing of lessons and knowledge production, ownership, and application worldwide. knowledge centrally aff ects all four pillars of global health, and global health governance is recognised to be central to all four domains (fi gure ). on the basis of this framework, china's modern timeline might be demarcated by fi ve landmarks. first, in , china sent its fi rst overseas medical team to algeria, followed years later by the donation of its fi rst hospital in tanzania. the explicitly articulated purpose of china's health aid was to further political solidarity as part of china's foreign policy. second was china's economic openings after , which launched the dramatic transformation of china from a low-income to a middle-income country, leading to china qualifying as an aid recipient followed by increasingly becoming an aid donor. third, starting from , china has hosted a series of forums on china-africa cooperation, with each forum announcing yet another major aid pledge-eg, hospital construction, malaria control, and high education scholarships ( - ); training of health workers and artemisinin drug donation ( - ); and brightness action (eye care) campaign ( - ). , fourth, global engagement greatly accelerated after when china entered the world trade organization (wto), an event that marked china's joining almost all international bodies. finally, and perhaps most dramatically, the severe acute repiratory syndrome (sars) epidemic underscored both china's neglect of its health sector and the reality that china's global trade cannot be done without mutual health protection. in recent years, the state council has published two white papers in april, , and july, , summarising china's foreign aid by volume and type. the white paper reports foreign aid of us$ · billion accumulated up to and including in three categories: grants of $ · billion; concessional loans of $ · billion; and interest-free loans of $ · billion. this amount is fairly close to another estimate of china's foreign aid at $ · billion cumulative from to , reaching $ · billion annually by . , the aid increased signifi cantly during the period of - , reaching an average of $ · billion per year, of which the grants accounted for · %. figure shows that african countries received % of all aid, with asia receiving about a third ( %) and latin america receiving around %, before the end of . the share for african countries increased to · % during the past years, whereas latin america received relatively less. another estimate computed china aid to africa in , at $ · billion in comparison with japan at $ · billion and usa at $ · billion. chinese aid in health is provided in fi ve categories: medical teams, construction of hospitals, donation of drugs and equipment, training of health personnel, and malaria control. the largest share of health aid is spent on medical teams and donated facilities. the fi nancial value of chinese in-kind health aid is diffi cult to estimate. crudely, from to , we estimated the value of chinese medical teams in africa to be about $ million annually, with donated facilities at a similar amount. total health aid to africa annually has been estimated at about $ million. understanding of the type of health support off ered rather than the precise volume of funding might be more important. diff erent from most oecd donors, china does not off er general sectoral support, albeit small cash grants given to several countries in recent years. its health aid uses a project approach. the in-kind provision in the fi ve categories is based on chinese competencies. health seems to constitute only a small proportion of the total chinese aid. health aid is mainly in donation form, whereas most of china's overall foreign aid is off ered as either concessional or interest-free loans. since , under the protocol on the dispatch of medical teams signed between the government of china and the recipient countries, about chinese medical workers have been sent to about countries to provide services to an estimated million people. at the end of , chinese medical workers were working in medical centres in countries. of the countries are in africa, and the remaining seven are mainly small countries-four in asia, one in europe, one in south america, and one in oceania. the table shows african countries in according to medical teams, aided facilities, and malaria control programmes, along with the chinese provinces twinned to each country. figure shows china health aid to africa with countries shaded according to density of medical team coverage and demarcated by aided facilities and malaria control. the distribution shows wide coverage of nearly all african countries with a higher density of medical teams in western and eastern africa regions. the largest and most powerful african countries such as south africa, nigeria, and kenya do not have chinese medical teams. chinese selection of hosting countries is based on country request and the joint decision by china's ministries of health, foreign aff airs, and fi nance. the medical teams are overseen by the chinese embassy economic and commercial counsellor's offi ces. medical teams are fi nanced by the health aid budget in the health ministry (except the basic salaries), which is responsible for dispatching medical teams. selected countries are twinned to specifi c chinese provinces with public hospitals and local medical schools responsible for staffi ng, supervising, and partially funding the medical teams. some practical criteria such as willingness and workload are used to match chinese provinces and recipient countries in the twinning arrangement. the number of members in medical teams ranges from a half dozen people to nearly , usually working out of chinese donated hospitals and clinics. most workers are clinicians, and most teams include a leader and a translator. public health skills are usually not included. medical teams mainly provide clinical services, especially for specialties in short supply-eg, surgery, gynaecology, and obstetrics. the average duration of an overseas assignment is years, with team members receiving housing and food plus enhanced salaries. over the period of - , these medical teams working in countries had provided about million medical consultations and treatments. panel describes some of these medical teams in southern sudan and the democratic republic of the congo. since , china has constructed more than a hundred health facilities overseas with its health aid. china accelerated its assistance in the construction of hospitals and clinics-from to , china has supported about construction projects of health facilities. most of these facilities are donated, and only a few are built as part of large infrastructure projects funded by chinese loans. african countries were the recipients of more than three-quarters of the donated facilities. although most countries have received at least one facility, some have received up to . these facilities are mostly so-called turnkey operations, for which chinese construction fi rms build the facility for transfer to local authorities. malaria control has recently been prioritised. control programmes are undertaken through anti-malaria centres, featuring artemisinin based on chinese traditional medicine. panel describes an ambitious chinese programme of malaria eradication with mass drug administration with artemisinin on the comoros islands. the question of whether health aid is mainly driven by china's commercial interest is not easy to investigate. much depends upon interpretation of underlying motivation. for example, chinese aid to africa might be viewed as either helping the world's poorest countries or building friendship with the origin of much of the world's energy and natural resources and potential export markets. a comprehensive analysis of this question would need access to data not currently available. as a preliminary fi rst step, we attempted to examine correlations between health aid and commercial economic indicators. regression analysis of african countries with variables of health aid (medical teams, donated facilities, malaria control) and economic interests (petroleum imports, china's foreign investment, and china's imports and exports) yielded no signifi cant pattern. figure shows four scatter-plots of china health aid and african trade. in the four diagrams, individual african countries are plotted according to health and commercial indicators. the scatter-plots did not show any association between medical aid and economic interests. spearman's rank correlation and t test analysis for the period of - showed no signifi cant fi ndings of correlations. these preliminary analyses should not be interpreted as conclusive. a core component of global health is mutual health protection against international transfer of health risks, which shows health interdependence. transborder movement of infectious diseases, contaminated goods and products, air pollution, and globally pooled co are prime examples. for china, the sars epidemic was a crisis with serious economic and political consequences. both disease control and international cooperation were delayed. chinese errors made in the early stage of sars have been acknowledged and have generated strong corrective measures, both domestically and internationally. domestic measures include major re-investment in the public health system via the chinese center for disease control and prevention (cdc), including development of the world's largest real-time electronic surveillance system. international eff orts include active participation and leadership in many international forums that foster cooperation in compliance of disease reporting and control, as shown by the initiation of the un resolution on enhancement of capacity-building in global public health in , and the joint international pledging conference on avian and human pandemic infl uenza with china, the european commission, and the world bank held in beijing in . [ ] [ ] [ ] subsequent management of infectious outbreaks such as avian infl uenza a h n virus shows that china recognises the importance of strict adherence to the international health regulations. in the sars outbreak, china needed days between fi rst case detection and report to who and another days for joint teams to investigate the outbreak. for h n one decade later, less than half the days lapsed between fi rst case and report to who and the initiation of joint investigations. [ ] [ ] [ ] infections can move in several directions. china has been the destination of cross-border infectious transmissions. in , a polio epidemic was imported from pakistan into china's xinjiang province. after making arduous eff orts and expending large resources. similarly, china has been threatened by the import of dengue fever, malaria, and several other transmissible diseases. , cross-border risks can also accompany the import and export of commodities. as the world's largest exporter of manufactured products, china, of course, transfers health risk overseas. news reports have been plentiful of contamination in chinese exports of toothpaste, lead paint, milk products, and heparin. [ ] [ ] [ ] [ ] these safety concerns are not limited to exporters. china has also been a destination in the dumping of contaminated chemicals from richer to poorer countries; these safety hazards are of equal concern to the chinese public. these concerns might be why china has upgraded its state food and drug administration (sfda) to the status of a ministry with larger budget, increased staff , and stronger regulatory powers. environmental pollution also moves across national boundaries. air pollutants in china have been cited as causing acid rain damage to forests in korea and japan. , china is today the world's largest emitter of carbon dioxide, contributing substantially to global climate change. to tackle air pollution, china's state council released an action plan setting a -year road map for air pollution control. its implementation deserves tracking for monitoring and evaluation of control eff ect. health governance sets ground rules for global stewardship of diverse activities. across the board, china has become an active member of the world system, opening with china's economic reform and accelerating after its entry into the wto in every aspect-eg, political (un), fi nancial (world bank, international monetary fund), economic (wto), and military (arm control and data underscore the participation of china in global governance. china's receipt of net offi cial development assistance and offi cial aid peaked at about $ million in , had steadily decreased to a third of that amount by , and is already disappearing as china increasingly becomes an aid donor rather than an aid recipient. from to , china's receipt and contribution to who were equal at about $ million. by - , china's assessed contribution to who had increased to $ million, while who funding to china had remained at baseline. in parallel with this increase in funding, the number of chinese staff members in who has expanded. whereas in , there were only chinese offi cials working in who, that number had tripled to by , although chinese staff in who are still under-represented. additionally, based on the newly released white paper, china allocated $ million to support the global fund and other international organisations in - . global health participation by china has been mainly governmental. in non-governmental stakeholders, growth in the international participation of some academic universities, business, and industry has occurred. china has very few non-governmental organisations (ngos) and thus the chinese are mostly absent from global civil society forums. a few international ngos work in china, but few have achieved offi cial registration from the chinese government. it will take substantial time, if ever, before china's civil society becomes active in global health. knowledge is both local and global, and its production, ownership, exchange, and application have global dimensions. china has much to share with and much to learn from the rest of the world. in medicine, strategy, and implementation, china has had some spectacular accomplishments, worthy contributions to the world's knowledge pool. chinese traditional medicine off ers many health-enhancing technologies-ranging from ephedrine to acu puncture. [ ] [ ] [ ] in the s, village health workers were fi eld tested, and later re-engineered as the barefoot doctor. china's three-tier rural health system was established soon after the founding of the people's republic. the alma ata movement for primary health care took great encouragement from china in showing what barefoot doctors could do at the community level. the three decades after the founding of the people's republic in witnessed some of the steepest advances of mortality control in human history. china's management of common infectious diseases, maternal-child health, tropical disease control, malaria and schistosomiasis containment, mass social hygiene campaigns, and recent achievement of near-universal health coverage are worthy of documentation as valuable lessons. physicians, two nurses, two chefs, two translators, and one medical engineer from shaanxi province constituted china's th medical team to sudan in - . the th chinese team from hebei province to the democratic republic of the congo arrived in , consisting of a team leader, physicians (including one in chinese traditional medicine), two nurses, one french translator, and one chef. for both teams, their primary role was to provide clinical care to patients. an ancillary function was to mentor, train, and improve the skill of local health workers. medical teams were self-suffi cient, bringing all their own supplies, equipment, and medicines. in response to questionnaires, team members commented positively on their experiences. higher salaries, fi nancial subsidies, and allowances from both central government and employers (about a six-fold increase) operated as important incentives. reported constraints included language barriers, unaccustomed disease profi les, poor facilities and equipment, unstable water and electricity supply, and homesickness. if the opportunity were off ered, nearly all would be willing to serve again. , panel : traditional chinese medicine to eradicate malaria? malaria eradication in some countries had been successful with dichlorodiphenyltrichloroethane, and hopes have focused on new vaccines. but a professor of chinese traditional medicine from guangzhou university of chinese medicine is leading an unprecedented eff ort to eradicate malaria on the comoros islands with traditional chinese medicine. starting in on moheli island where % of the residents were carriers of plasmodium falciparum, disease prevalence has dropped to · % in months with mass administration of artemisinin and piperaquine, donated by china's ministry of commerce. years later, the chinese team extended this programme to anjouan, an island of , reducing the prevalence of p falciparum carriers from % to · %. last year, the eff orts were expanded to the residents of grande comore, the country's largest island. the project goal is malaria eradication in the people of the comoros by . panel describes an innovative grant by uk government's department for international develop ment (dfid) to foster research by, and capacity building for chinese universities and other institutions to disseminate and share chinese lessons with other countries. for the future, china aspires to be a worldwide knowledge leader and it has fast growing research and development investments in biomedicine. chakma reported china's biomedical research and development at $ · billion in , in comparison with usa ($ billion), europe ($ billion), and japan ($ billion). the absolute size of these fi gures might undervalue chinese investments because the lower salaries, cost of infrastructure, and cost of operations in china might not be captured fully by purchasing power parity-adjusted values. strikingly, china's investments since have increased annually at % in comparison, for example, to − % for the usa. china, moreover, houses laboratories for most of the major pharmaceutical companies. it has advanced genetic research capacity as shown by its genetic sequencing of the h n virus within days of isolation and identifi cation. china is also a growing producer and exporter of generic products. china aspires to be a powerhouse in the discovery and production of new drugs and vaccines in global health. china's medical universities are increasingly undertaking research and education in global health. in the past year, several new multidisciplinary centres of china supports government offi cials, technical professionals, and young people from developing countries to participate in training and education programmes in china. in - , the government provided scholarships for such programmes, of which many were health related. china's medical universities also train foreign medical students. according to the data from the china education yearbook, in - , china trained foreign medical students, who constitute % of all foreign students in . for that year, the ministry of education reported almost foreign medical students studying modern medicine and studying traditional chinese medicine. , by , china had extended authorisation to medical schools to admit foreign students who will study medicine in english. figure shows the rapid increase of foreign medical students and scholarships in china in - . although foreign interest in traditional medicine is high, most foreign students register for modern medicine. about % of the foreign medical students receive chinese government scholarships that might be regarded as part of china's foreign health aid. chinese medical schools charge foreign students higher than chinese tuition fees, and the schools acknowledge foreign students as a source of school revenue. in , many of the students came from neighbouring asian countries, such as india, japan, pakistan, south korea, and southeast asia. our most salient fi nding is china's distinctive mode of engagement in global health. china's health aid volume is small, but the mode is distinctive, driven by china's health capabilities and national experiences. unlike many other traditional donors, china's in-kind aid focuses more on some important aspects of the health system. china's overall global engagement follows a very diff erent path from developed countries partly because it has no colonial experience nor did it participate in shaping the american-led post-world war world order. china was inward-looking until it expanded into the global economy in . over the ensuing three decades, china has had large shifts from a low-income to a middle-income country, and from aid recipient increasingly to aid donor. the spread of its foreign aid throughout the breadth of africa presumably refl ects both eff orts to solidify friendship politically, promote mutually benefi cial economic gains, and compete with taiwan for political friendship. china's health aid is embedded in the dynamic shifting of foreign and economic policies. the opening in marked a shift from economic development serving foreign policy to foreign policy serving economic development because china's association, for example, with africa, has developed from a political one in the s to a broader economic-based and trade-based engagement. , these are all defi ning characteristics of china's engagement in global health. china's global health work, unfortunately, does not seem to rank highly in government agencies. health has been assigned a lower position than political and commercial aff airs. taking advantage of both domestic and international resources and accessing both domestic and international markets is china's explicit national development strategy. these powerful economic motives drive much of china's global engagement, including its engagement in africa, to the point where the dividing line between trade and aid become blurred and hard to demarcate. health aid is only a very small adjunct to these much larger and more powerful forces. china's overseas forces include several government agencies. as a result, improved interministerial coordination is a necessary development for the evolution of a coherent overall engagement in global health. formulation of a china global health strategy could help bring coherent policy and harmonised action, because it would compel the articulation of specifi c health and humanitarian objectives in chinese governmental policies. an explicit china global health strategy would provide a stronger context for ngos and private sector overseas participation. china's bilateral approach diff ers substantially from its multilateral approach. although china's bilateralism takes an independent approach, china's multilateral strategy is full participation, joining as a regular member and complying with its responsibilities and privileges in un bodies such as who. the records show that china respects and complies with rules governing multilateral institutions in all aff airs-health, trade, migration, environment, and other aspects of global governance. china has increased its contribution to multilateral funding pools, such as the global fund from $ million per year in , to $ million per year in . how important china will become as a major donor to these pooled funds is uncertain. some see the early actions as symbolic gestures of cofunding, whereas others hope that the size of the chinese economy will propel it to become a fi nancial leader of multilateral funds. the new development bank being established by brics countries aims to compete with the world bank and international monetary fund, which is one example of how china has debatably played a leadership role. most important is the avoidance of over-simplifi cation. no country's international engagement is free from political or economic motives-eg, europe colonialism, us millennium development accounts, or sweden-vietnam partnership during the american war. and no single modality of foreign aid has proven to be more eff ective or more sustainable. , although china's health aid is generally appreciated by recipient offi cial statements, there are indeed complaints about the scale of china's intrusion, access to natural resources, and the trade market in africa. but energy resource-based trade structure with africa does not occur only in china; it occurs with all major african trading partners. the most fundamental improvement is to increase the capacity for independent development, to which all partners in africa should contribute. china's global health engagement is diffi cult to attribute to one motivation factor. chinese driving forces are undoubtedly several and complex-political, economic, social, and humanitarian. china's approach has been characterised as pragmatic that "combines the utilitarian logic of reaping material benefi t, the realist objective of expanding its global power and infl uence, the neo-liberalist interest in pursuing absolute gains from international cooperation, and the constructivist attempt to become a responsible stakeholder in the system". china's global health engagement will probably grow 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china. the state council issues action plan on prevention and control of air pollution introducing ten measures to improve air quality data: net offi cial development assistance and offi cial aid received (current us$) who. financial and auditing reports from world health assembly, from wha to wha who. human resources: annual report chinese materia medica: chemistry, pharmacology and applications chinese acupuncture and moxibustion asian medicine. the new face of traditional chinese medicine health service delivery in china: a literature review mortality in china global health support programme supports shared international development objectives uk global health support programme (ghsp) asia's ascent-global trends in biomedical r&d expenditures duke kunshan university, and the leading chinese universities launch new global health consortium liberal education meets chinese tradition china consortium of universities for global health established in beijing ministry of education of people's republic of china. china education yearbook . beijing: people's education press ministry of education of people's republic of china. brief statistics of international students in china new list of chinese medical institutions admitting international students for academic year ministry of education of people's republic of china. interim provisions to control the quality of foreign students' undergraduate education (english class) in china beyond borders: potential gaps in the international system of public health surveillance china: foreign policy serves domestic development china's priorities in africa: enhancing engagements collection of important documents since third plenary session emerging economics to launch development five metaphors about global-health policy development assistance for health: critiques and proposals for change the great escape: health, wealth, and the origins of inequality china and global health governance we thank haomin yang, yang li, and jing bai for their work on data collection, data analysis, and research assistance. key: cord- - gpkb nm authors: appireddy, ramana; jalini, shirin; shukla, garima; boissé lomax, lysa title: tackling the burden of neurological diseases in canada with virtual care during the covid- pandemic and beyond date: - - journal: the canadian journal of neurological sciences. le journal canadien des sciences neurologiques doi: . /cjn. . sha: doc_id: cord_uid: gpkb nm nan approximately % of canadians are affected by neurological disorders based on canada's national population health study of neurological conditions, and this number is projected to increase in the coming decades. those with chronic neurological conditions have higher stress levels and a higher prevalence of selfdiagnosed mood or anxiety disorders. many suffer functional impairments with regard to cognition, mobility, dexterity, bowel, and bladder control. taken together, these factors lead to significant impacts on quality of life. neurological disease can also affect one's ability to work or work productively, which can lead to financial insecurity. it can also result in a significant loss of the number of years ( - years based on condition) of healthy living. based on the results from the living with the impact of a neurological condition (linc) project, those with chronic neurological conditions use more health care services across the continuum compared to other chronic health conditions. in a study from british columbia, physician service utilization is . - . times higher in people with chronic neurological conditions, as are the total direct health costs and out-of-pocket expenses for people affected by chronic neurological conditions. there are also limitations in health care services for this population with the physical environment cited as one of the significant barriers to the provision of adequate services. thus, the burden of neurological diseases is not only shared by the individuals and families affected by it but also by the health care system. there is an urgent need within our health care system to address the unmet needs of individuals suffering from neurological disease. though it is not always easy to address the underlying biological mechanisms of these conditions, the health system performance can be optimized by adopting the institute for healthcare improvement's triple aim. this constitutes ( ) reducing the per-capita cost of health care (out-ofpocket expenses and health system cost), ( ) improving patient experiences of care (including quality and satisfaction), and ( ) improving the health of populations. virtual health care solutions are one way we can offer transformative changes to the practice of neurological ambulatory care in canada, in order to meet some of the unmet needs of this challenging patient population. , compounding the challenges mentioned above, the impact of covid- on our health care is perceived by all. the covid- crisis has resulted in temporary cancellation of elective clinics and all non-urgent/emergent clinical encounters in mid-late march across the country. a similar policy has resulted in cancellation of hundreds of outpatient encounters across all neurology clinics over the last few weeks. some urgent and essential clinics like stroke prevention clinics and multiple sclerosis clinics were also indirectly affected by the covid- crisis due to patients' hesitation to come to a health care facility during the crisis. their concern is genuine given the demographics (seniors in the stroke clinic) and patient characteristics (immunocompromised patients on multiple sclerosis medications). to meet the clinical needs of the patient care, the division of neurology at queen's university had completely transformed to a virtual care service to be able to provide the care. the transformation was significantly facilitated by the ontario ministry of health's decision to develop virtual care billing codes. virtual care has been defined as any interaction occurring remotely between patients and/or members of their circle of care, through any form of communication or information technology with the aim of facilitating or maximizing the quality and effectiveness of patient care. , this can include secure messaging, secure email, or secure personal videoconferencing. secure personal videoconferencing, also referred to as evisit, is the use of personal internet-enabled devices like smartphones and tablets to videoconference with patients, with the goal to keep the patient at home or their preferred location. digital health solutions are also adopted by the federal and provincial authorities as a key priority area of innovation to reduce health care costs. , there is also growing demand by patients to have access to such services, as seen in a nationally representative survey of canadians' opinions on health care access. we have successfully implemented evisit pilot project in in the stroke clinic. the results of our pilot study demonstrated a very high degree of patient satisfaction, reduction in per capita health care costs, out of pocket expenses [mean(sd): $ . ( . ) cnd; median(iqr): $ . ( . - . ) cnd], health system costs (range between $ , to $ , dollars, just from the pilot), and statistically significant reduction in wait times for an evisit follow-up compared to in-person follow-up. physicians were able to assess patients more quickly via evisit than via an in-person encounter, thus increasing the timely availability of health care. adopting virtual care solutions can also result in a significant reduction in costs. the cost saving is a conservative estimate, and the actual figures are likely higher if other factors and social determinants like childcare, income status, other personal factors, and visit characteristics were accounted for. our evisit pilot project in neurology has made a provincial impact and is considered as an innovative model by the ontario telemedicine network. provided through the ontario telemedicine network, evisits were used exclusively for follow-up of clinical activities like the review of investigations, symptom management, therapeutic decisions, medication titration, other specialist consultations, patient counselling, and education. following the successful experience from the pilot, the evisits were scaled to other clinics in neurology (sleep, epilepsy, and stroke). the evisits were done from physicians' offices using the office computers. the neurological examination is completed by following standard protocols adopted in other teleneurology settings like stroke and parkinson's disease. [ ] [ ] [ ] patients are advised to record their blood pressure at home. the medication reconciliation is done by verifying the medications at home against a medication list obtained from the pharmacy prior to the evisits. the scheduling of evisits differs across physicians: from sprinkling the evisits in -minute slots during their week to scheduling them for an entire afternoon. in the epilepsy clinic, the evisit follow-ups have replaced an entire in-person follow-up clinic for two physicians (lbl, gs). clinic space that was freed up by the evisits was allocated to other physicians in need of clinic space. the high uptake in these clinics is due to multiple factors including the nature of the disease, patient barriers to accessing outpatient care (lack of driving privileges, physical disability, etc.), as well as the limited requirement for detailed hands-on neurological examination during follow-ups for epilepsy and sleep. we are also using the platform to reduce inter-hospital transfers from a local rehabilitation facility to the outpatient clinic for follow-up appointments. virtual care modalities are hugely patient centric and enable physicians to identify risks and patient vulnerabilities sooner, improve treatment adherence, support behavioral and care interventions to improve speech, mobility, and arrange timely access to home care or community-based care/allied health services. some of the other patient-related factors specific to neurological conditions like epilepsy and sleep are the driving restrictions, the limited requirement for detailed neurological examination during follow-up, ease of assessing speech, eye movements, coordination and gait through evisit, cognitive and psychiatric co-morbidities causing frustration in waiting areas and the general hospital environment in general, privacy concerns due to accompaniment by family members for transportation needs. evisits allow patients and providers to avoid traffic and congestion. it also allows patients to avoid adverse weather and road conditions, which is a challenge in both urban centers and remote communities, where sheer distances to travel for appointments are significant. this is particularly important for patient populations with neurological conditions, who often have driving restrictions or limitations. evisits also allow patients the flexibility of scheduling their follow-up evisit at a time and location convenient for them and their families. family members are able to join the evisit remotely, offering increased support to patients, which is particularly crucial for seniors. overall, the evisit model of care aligns with picker's principles of patient-centered care. evisits also have the potential to improve population health by reducing barriers to care, reduce wait times, and improve access to timely care. physicians and other health care providers benefit from evisit's flexible scheduling, which allows being more productive with their time, enabling them to distribute their clinical activity to accommodate other commitments, including teaching, research, and administration. in addition to increased productivity, evisits have the potential to address some of the significant contributors to physician burnout (work and organizational factors), which, in turn, can have consequences on patient care and health care costs. evisit also reduces the need for admin/nursing support typically needed in the clinic setting, thus further reducing the overhead costs. suitability of patients and their follow-up plan for evisits should be an individualized decision made mutually by the physician and the patient to ensure safety. virtual care uptake has been significant in canada and has facilitated safe, timely, and accessible ambulatory care during this covid- crisis. this has resulted in capacity issues for the existing ontario telemedicine network, the provincial telemedicine provider. the ministry of health has allowed health care providers to use video visits and telephone for providing ambulatory care during the covid- crisis. broadly, the virtual care platforms fall under regulated and unregulated categories and guidance on appropriate use, the disclaimer, and consent are available here. a comprehensive list of guidance on virtual care and platforms available across canada is available here. use of regulated platforms that meet the privacy and security standards for safeguarding personal health care information is strongly recommended. at queen's university/kingston health sciences center, reacts (www.reacts. com) and otn are being used for providing virtual care. since the covid- crisis, we have expanded the scope of evisits to include new consultations. patients are seen in-person only if the attending neurologists feel that a reasonable diagnosis cannot be made via evisit, and if the clinical situations warrant an urgent/emergency consultation. in our experience, we have faced many challenges and barriers to convert and sustain patients to receive virtual care, especially video visits. the challenges span across the spectrum of adoption regarding a new technology by patients and include the lack of access to technology (smart devices, computers), reliable internet connection, know-how of using technology, and ease of navigating the user interface of the virtual care platform. we have been using the telephone for contacting the patients that are not capable of doing virtual visits. telephone visits are remunerated on a temporary basis in some provinces, and are ideal for follow-up visits to convey results and answer questions. the limitations of telephone calls include the inability to properly validate the patient and physician identification, lack of physical examination, and accurate medical reconciliation. despite the limitations of telephone visits, they offer a very convenient option for many and further study of the safety, efficacy should be tested. current clinical practice standards, regulatory standards, and physician remuneration are based around traditional forms of medical care performed through in-person interaction. extensive guidelines and frameworks exist around these issues to guide clinicians. yet, a similar framework for various virtual care modalities is yet to exist and is perceived as an immediate need by the canadian medical association, royal college of physicians and surgeons (canada), and college of family physicians of canada. , , another significant barrier is physician remuneration. this, however, looks promising, given the ongoing work by the canadian medical association led virtual care task force as well as new digital health policies adopted by provincial health care authorities. , , conclusion many of the chronic neurological diseases need long-term and regular follow-up for clinical activities like symptom management, medication titration, review of investigations, patient education, and counselling. as a community of health care providers caring for the people and families affected by neurological diseases, it is our duty and responsibility to leverage the existing technologies available to reduce the burden on the patients, families, health care system, and ultimately society. extraordinary times require extraordinary measures. as the current covid- pandemic is projected to last for a few more months, it is imperative for the neurology community to embrace virtual care to continue to provide care to patients affected by neurological conditions. the adoption of virtual care into a neurological practice at this time will ensure that timely care is provided to patients simultaneously avoiding contact with the hospitals, avoiding long wait lists in the future. mapping connections: an understanding of neurological conditions in canada. ottawa: public health agency of canada the everyday experience of living with and managing a neurological condition (the linc study): study design a guide to measuring the triple aim: population health, experience of care, and per capita cost. ihi innovation series white paper modernizing canada's healthcare system through the virtualization of services billing for virtual physician services and technical guidance virtual care policy recommendations for patient-centred primary care: findings of a consensus policy dialogue using a nominal group technique virtual care: recommendations for scaling up virtual medical services: report of the virtual care task force ontario health teams: digital health playbook ottawa: ministry of health access : canada health infoway connecting patients for better health home virtual visits for outpatient follow-up stroke care: cross-sectional study how virtual care can increase your practice's roi toronto: on.call valuing citizen access to digital health services: applied value-based outcomes in the canadian context and tools for modernizing health systems connected care update ottawa: ministry of health remotely assessing symptoms of parkinson's disease using videoconferencing: a feasibility study role for telemedicine in acute stroke. feasibility and reliability of remote administration of the nih stroke scale telemedicine in general neurology: interrater reliability of clinical neurological examination via audio-visual telemedicine video conference technology helps connect patient to care providers picker principles of person centred care one hospital's experiments in virtual health care: harvard business review factors related to physician burnout and its consequences: a review expanded access to virtual care for all physicians. ontario medical association telemedicine and virtual care guidelines (and other clinical resources for covid- ): royal college of physicians and surgeons of canada iit reacts | interactive audio-video platform task force launching to examine national licensure for virtual care virtual care in canada : discussion paper. cma health summit key: cord- -k imddzr authors: siegel, jane d.; rhinehart, emily; jackson, marguerite; chiarello, linda title: guideline for isolation precautions: preventing transmission of infectious agents in health care settings date: - - journal: am j infect control doi: . /j.ajic. . . sha: doc_id: cord_uid: k imddzr nan . clinical syndromes or conditions warranting additional empiric transmission-based precautions pending confirmation of diagnosis table . infection control considerations for highpriority (cdc category a) diseases that may result from bioterrorist attacks or are considered bioterrorist threats table . recommendations for application of standard precautions for the care of all patients in all health care settings table . components of a protective environment . the transition of health care delivery from primarily acute care hospitals to other health care settings (eg, home care, ambulatory care, freestanding specialty care sites, long-term care) created a need for recommendations that can be applied in all health care settings using common principles of infection control practice, yet can be modified to reflect setting-specific needs. accordingly, the revised guideline addresses the spectrum of health care delivery settings. furthermore, the term ''nosocomial infections'' is replaced by ''health care-associated infections'' (hais), to reflect the changing patterns in health care delivery and difficulty in determining the geographic site of exposure to an infectious agent and/ or acquisition of infection. . the emergence of new pathogens (eg, severe acute respiratory syndrome coronavirus [sars-cov] associated with sars avian influenza in humans), renewed concern for evolving known pathogens (eg, clostridium difficile, noroviruses, communityassociated methicillin-resistant staphylococcus aureus [ca-mrsa]), development of new therapies (eg, gene therapy), and increasing concern for the threat of bioweapons attacks, necessitates addressing a broader scope of issues than in previous isolation guidelines. . the successful experience with standard precautions, first recommended in the guideline, has led to a reaffirmation of this approach as the foundation for preventing transmission of infectious agents in all health care settings. new additions to the recommendations for standard precautions are respiratory hygiene/cough etiquette and safe injection practices, including the use of a mask when performing certain highrisk, prolonged procedures involving spinal canal punctures (eg, myelography, epidural anesthesia). the need for a recommendation for respiratory hygiene/cough etiquette grew out of observations during the sars outbreaks, when failure to implement simple source control measures with patients, visitors, and health care workers (hcws) with respiratory symptoms may have contributed to sars-cov transmission. the recommended practices have a strong evidence base. the continued occurrence of outbreaks of hepatitis b and hepatitis c viruses in ambulatory settings indicated a need to reiterate safe injection practice recommendations as part of standard precautions. the addition of a mask for certain spinal injections grew from recent evidence of an associated risk for developing meningitis caused by respiratory flora. . the accumulated evidence that environmental controls decrease the risk of life-threatening fungal infections in the most severely immunocompromised patients (ie, those undergoing allogeneic hematopoietic stem cell transplantation [hsct] ) led to the update on the components of the protective environment (pe). . evidence that organizational characteristics (eg, nurse staffing levels and composition, establishment of a safety culture) influence hcws' adherence to recommended infection control practices, and thus are important factors in preventing transmission of infectious agents, led to a new emphasis and recommendations for administrative involvement in the development and support of infection control programs. . continued increase in the incidence of hais caused by multidrug-resistant organisms (mdros) in all health care settings and the expanded body of knowledge concerning prevention of transmission of mdros created a need for more specific recommendations for surveillance and control of these pathogens that would be practical and effective in various types of health care settings. this document is intended for use by infection control staff, health care epidemiologists, health care administrators, nurses, other health care providers, and persons responsible for developing, implementing, and evaluating infection control programs for health care settings across the continuum of care. the reader is referred to other guidelines and websites for more detailed information and for recommendations concerning specialized infection control problems. part i reviews the relevant scientific literature that supports the recommended prevention and control practices. as in the guideline, the modes and factors that influence transmission risks are described in detail. new to the section on transmission are discussions of bioaerosols and of how droplet and airborne transmission may contribute to infection transmission. this became a concern during the sars outbreaks of , when transmission associated with aerosol-generating procedures was observed. also new is a definition of ''epidemiologically important organisms'' that was developed to assist in the identification of clusters of infections that require investigation (ie multidrug-resistant organisms, c difficile). several other pathogens of special infection control interest (ie, norovirus, sars, centers for disease control and prevention [cdc] category a bioterrorist agents, prions, monkeypox, and the hemorrhagic fever viruses) also are discussed, to present new information and infection control lessons learned from experience with these agents. this section of the guideline also presents information on infection risks associated with specific health care settings and patient populations. part ii updates information on the basic principles of hand hygiene, barrier precautions, safe work practices, and isolation practices that were included in previous guidelines. however, new to this guideline is important information on health care system components that influence transmission risks, including those components under the influence of health care administrators. an important administrative priority that is described is the need for appropriate infection control staffing to meet the ever-expanding role of infection control professionals in the complex modern health care system. evidence presented also demonstrates another administrative concern: the importance of nurse staffing levels, including ensuring numbers of appropriately trained nurses in intensive care units (icus) for preventing hais. the role of the clinical microbiology laboratory in supporting infection control is described, to emphasize the need for this service in health care facilities. other factors that influence transmission risks are discussed, including the adherence of hcws to recommended infection control practices, organizational safety culture or climate, and education and training. discussed for the first time in an isolation guideline is surveillance of health care-associated infections. the information presented will be useful to new infection control professionals as well as persons involved in designing or responding to state programs for public reporting of hai rates. part iii describes each of the categories of precautions developed by the health care infection control practices advisory committee (hicpac) and the cdc and provides guidance for their application in various health care settings. the categories of transmission-based precautions are unchanged from those in the guideline: contact, droplet, and airborne. one important change is the recommendation to don the indicated personal protective equipment (ppe-gowns, gloves, mask) on entry into the patient's room for patients who are on contact and/or droplet precautions, because the nature of the interaction with the patient cannot be predicted with certainty, and contaminated environmental surfaces are important sources for transmission of pathogens. in addition, the pe for patients undergoing allogeneic hsct, described in previous guidelines, has been updated. five tables summarize important information. table provides a summary of the evolution of this document. table gives guidance on using empiric isolation precautions according to a clinical syndrome. table summarizes infection control recommendations for cdc category a agents of bioterrorism. table lists the components of standard precautions and recommendations for their application, and table lists components of the pe. a glossary of definitions used in this guideline also is provided. new to this edition of the guideline is a figure showing the recommended sequence for donning and removing ppe used for isolation precautions to optimize safety and prevent self-contamination during removal. appendix a provides an updated alphabetical list of most infectious agents and clinical conditions for which isolation precautions are recommended. a preamble to the appendix provides a rationale for recommending the use of or more transmission-based precautions in addition to standard precautions, based on a review of the literature and evidence demonstrating a real or potential risk for person-to-person transmission in health care settings. the type and duration of recommended precautions are presented, with additional comments concerning the use of adjunctive measures or other relevant considerations to prevent transmission of the specific agent. relevant citations are included. new to this guideline is a comprehensive review and detailed recommendations for prevention of transmission of mdros. this portion of the guideline was published electronically in october and updated in november (siegel jd, rhinehart e, jackson m, chiarello l and hicpac. management of multidrug-resistant organisms in health care settings, ; available from http://www.cdc.gov/ ncidod/dhqp/pdf/ar/mdroguideline .pdf), and is considered a part of the guideline for isolation precautions. this section provides a detailed review of the complex topic of mdro control in health care settings and is intended to provide a context for evaluation of mdro at individual health care settings. a rationale and institutional requirements for developing an effective mdro control program are summarized. although the focus of this guideline is on measures to prevent transmission of mdros in health care settings, information concerning the judicious use of antimicrobial agents also is presented, because such practices are intricately related to the size of the reservoir of mdros, which in turn influences transmission (eg, colonization pressure). two tables summarize recommended prevention and control practices using categories of interventions to control mdros: administrative measures, education of hcws, judicious antimicrobial use, surveillance, infection control precautions, environmental measures, and decolonization. recommendations for each category apply to and are adapted for the various health care settings. with the increasing incidence and prevalence of mdros, all health care facilities must prioritize effective control of mdro transmission. facilities should identify prevalent mdros at the facility, implement control measures, assess the effectiveness of control programs, and demonstrate decreasing mdro rates. a set of intensified mdro prevention interventions is to be added if the incidence of transmission of a target mdro is not decreasing despite implementation of basic mdro infection control measures, and when the first case of an epidemiologically important mdro is identified within a health care facility. this updated guideline responds to changes in health care delivery and addresses new concerns about transmission of infectious agents to patients and hcws in the united states and infection control. the primary objective of the guideline is to improve the safety of the nation's health care delivery system by reducing the rates of hais. instruct symptomatic persons to cover mouth/nose when sneezing/ coughing; use tissues and dispose in no-touch receptacle; observe hand hygiene after soiling of hands with respiratory secretions; wear surgical mask if tolerated or maintain spatial separation, . feet if possible. *during aerosol-generating procedures on patients with suspected or proven infections transmitted by respiratory aerosols (eg, severe acute respiratory syndrome), wear a fittested n or higher respirator in addition to gloves, gown, and face/eye protection. -proper construction of windows, doors, and intake and exhaust ports -ceilings: smooth, free of fissures, open joints, crevices -walls sealed above and below the ceiling -if leakage detected, locate source and make necessary repairs d ventilation to maintain $ air changes/hour d directed air flow; air supply and exhaust grills located so that clean, filtered air enters from one side of the room, flows across the patient's bed, and exits on opposite side of the room d positive room air pressure in relation to the corridor; pressure differential of . . pa ( . -inch water gauge) d air flow patterns monitored and recorded daily using visual methods (eg, flutter strips, smoke tubes) or a hand-held pressure gauge d self-closing door on all room exits d back-up ventilation equipment (eg, portable units for fans or filters) maintained for emergency provision of ventilation requirements for pe areas, with immediate steps taken to restore the fixed ventilation system d for patients who require both a pe and an airborne infection isolation room (aiir), use an anteroom to ensure proper air balance relationships and provide independent exhaust of contaminated air to the outside, or place a hepa filter in the exhaust duct. ( ) reaffirm standard precautions as the foundation for preventing transmission during patient care in all health care settings; ( ) reaffirm the importance of implementing transmission-based precautions based on the clinical presentation or syndrome and likely pathogens until the infectious etiology has been determined ( table ) ; and ( ) provide epidemiologically sound and, whenever possible, evidence-based recommendations. this guideline is designed for use by individuals who are charged with administering infection control programs in hospitals and other health care settings. the information also will be useful for other hcws, health care administrators, and anyone needing information about infection control measures to prevent transmission of infectious agents. commonly used abbreviations are provided, and terms used in the guideline are defined in the glossary. medline and pubmed were used to search for relevant studies published in english, focusing on those published since . much of the evidence cited for preventing transmission of infectious agents in health care settings is derived from studies that used ''quasiexperimental designs,'' also referred to as nonrandomized preintervention and postintervention study designs. although these types of studies can provide valuable information regarding the effectiveness of various interventions, several factors decrease the certainty of attributing improved outcome to a specific intervention. these include: difficulties in controlling for important confounding variables, the use of multiple interventions during an outbreak, and results that are explained by the statistical principle of regression to the mean (eg, improvement over time without any intervention). observational studies remain relevant and have been used to evaluate infection control interventions. , the quality of studies, consistency of results, and correlation with results from randomized controlled trials, when available, were considered during the literature review and assignment of evidencebased categories (see part iv: recommendations) to the recommendations in this guideline. several authors have summarized properties to consider when evaluating studies for the purpose of determining whether the results should change practice or in designing new studies. , , this guideline contains changes in terminology from the guideline: . the term ''nosocomial infection'' is retained to refer only to infections acquired in hospitals. the term ''health care-associated infection'' (hai) is used to refer to infections associated with health care delivery in any setting (eg, hospitals, long-term care facilities, ambulatory settings, home care). this term reflects the inability to determine with certainty where the pathogen was acquired, because patients may be colonized with or exposed to potential pathogens outside of the health care setting before receiving health care, or may develop infections caused by those pathogens when exposed to the conditions associated with delivery of health care. in addition, patients frequently move among the various settings within the health care system. of infectious agents, a susceptible host with a portal of entry receptive to the agent, and a mode of transmission for the agent. this section describes the interrelationship of these elements in the epidemiology of hais. i.b. . sources of infectious agents. infectious agents transmitted during health care derive primarily from human sources but inanimate environmental sources also are implicated in transmission. human reservoirs include patients, [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] hcws, , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] and household members and other visitors. [ ] [ ] [ ] [ ] [ ] [ ] such source individuals may have active infections, may be in the asymptomatic and/or incubation period of an infectious disease, or may be transiently or chronically colonized with pathogenic microorganisms, particularly in the respiratory and gastrointestinal tracts. other sources of hais are the endogenous flora of patients (eg, bacteria residing in the respiratory or gastrointestinal tract). [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] i.b. . susceptible hosts. infection is the result of a complex interrelationship between a potential host and an infectious agent. most of the factors that influence infection and the occurrence and severity of disease are related to the host. however, characteristics of the host-agent interaction as it relates to pathogenicity, virulence, and antigenicity also are important, as are the infectious dose, mechanisms of disease production, and route of exposure. there is a spectrum of possible outcomes after exposure to an infectious agent. some persons exposed to pathogenic microorganisms never develop symptomatic disease, whereas others become severely ill and even die. some individuals are prone to becoming transiently or permanently colonized but remain asymptomatic. still others progress from colonization to symptomatic disease either immediately after exposure or after a period of asymptomatic colonization. the immune state at the time of exposure to an infectious agent, interaction between pathogens, and virulence factors intrinsic to the agent are important predictors of an individual's outcome. host factors such as extremes of age and underlying disease (eg, diabetes , , human immunodeficiency virus/acquired immune deficiency syndrome [hiv/ aids], , malignancy, and transplantation , , ) can increase susceptibility to infection, as can various medications that alter the normal flora (eg, antimicrobial agents, gastric acid suppressors, corticosteroids, antirejection drugs, antineoplastic agents, immunosuppressive drugs). surgical procedures and radiation therapy impair defenses of the skin and other involved organ systems. indwelling devices, such as urinary catheters, endotracheal tubes, central venous and arterial catheters, [ ] [ ] [ ] and synthetic implants, facilitate development of hais by allowing potential pathogens to bypass local defenses that ordinarily would impede their invasion and by providing surfaces for development of biofilms that may facilitate adherence of microorganisms and protect from antimicrobial activity. some infections associated with invasive procedures result from transmission within the health care facility; others arise from the patient's endogenous flora. clothing, uniforms, laboratory coats, or isolation gowns used as ppe may become contaminated with potential pathogens after care of a patient colonized or infected with an infectious agent, (eg, mrsa, vancomycin-resistant enterococci [vre], and c difficile ). although contaminated clothing has not been implicated directly in transmission, the potential exists for soiled garments to transfer infectious agents to successive patients. i.b. .b. droplet transmission. droplet transmission is technically a form of contact transmission; some infectious agents transmitted by the droplet route also may be transmitted by direct and indirect contact routes. however, in contrast to contact transmission, respiratory droplets carrying infectious pathogens transmit infection when they travel directly from the respiratory tract of the infectious individual to susceptible mucosal surfaces of the recipient, generally over short distances, necessitating facial protection. respiratory droplets are generated when an infected person coughs, sneezes, or talks , or during such procedures as suctioning, endotracheal intubation, [ ] [ ] [ ] [ ] cough induction by chest physiotherapy, and cardiopulmonary resuscitation. , evidence for droplet transmission comes from epidemiologic studies of disease outbreaks, [ ] [ ] [ ] [ ] from experimental studies, and from information on aerosol dynamics. , studies have shown that the nasal mucosa, conjunctivae, and, less frequently, the mouth are susceptible portals of entry for respiratory viruses. the maximum distance for droplet transmission is currently unresolved; pathogens transmitted by the droplet route have not been transmitted through the air over long distances, in contrast to the airborne pathogens discussed below. historically, the area of defined risk has been a distance of , feet around the patient, based on epidemiologic and simulated studies of selected infections. , using this distance for donning masks has been effective in preventing transmission of infectious agents through the droplet route. however, experimental studies with smallpox , and investigations during the global sars outbreaks of suggest that droplets from patients with these infections could reach persons located feet or more from their source. it is likely that the distance that droplets travel depends on the velocity and mechanism by which respiratory droplets are propelled from the source, the density of respiratory secretions, environmental factors (eg, temperature, humidity), and the pathogen's ability to maintain infectivity over that distance. thus, a distance of , feet around the patient is best considered an example of what is meant by ''a short distance from a patient'' and should not be used as the sole criterion for determining when a mask should be donned to protect from droplet exposure. based on these considerations, it may be prudent to don a mask when within to feet of the patient or on entry into the patient's room, especially when exposure to emerging or highly virulent pathogens is likely. more studies are needed to gain more insight into droplet transmission under various circumstances. droplet size is another variable under investigation. droplets traditionally have been defined as being . mm in size. droplet nuclei (ie, particles arising from desiccation of suspended droplets) have been associated with airborne transmission and defined as , mm in size, a reflection of the pathogenesis of pulmonary tuberculosis that is not generalizeable to other organisms. observations of particle dynamics have demonstrated that a range of droplet sizes, including those of diameter $ mm, can remain suspended in the air. the behavior of droplets and droplet nuclei affect recommendations for preventing transmission. whereas fine airborne particles containing pathogens that are able to remain infective may transmit infections over long distances, requiring aiir to prevent its dissemination within a facility; organisms transmitted by the droplet route do not remain infective over long distances and thus do not require special air handling and ventilation. examples of infectious agents transmitted through the droplet route include b pertussis, influenza virus, adenovirus, rhinovirus, mycoplasma pneumoniae, sars-cov, , , group a streptococcus, and neisseria meningitides. , , although rsv may be transmitted by the droplet route, direct contact with infected respiratory secretions is the most important determinant of transmission and consistent adherence to standard precautions plus contact precautions prevents transmission in health care settings. , , rarely, pathogens that are not transmitted routinely by the droplet route are dispersed into the air over short distances. for example, although s aureus is transmitted most frequently by the contact route, viral upper respiratory tract infection has been associated with increased dispersal of s aureus from the nose into the air for a distance of feet under both outbreak and experimental conditions; this is known as the ''cloud baby'' and ''cloud adult'' phenomenon. [ ] [ ] [ ] i.b. .c. airborne transmission. airborne transmission occurs by dissemination of either airborne droplet nuclei or small particles in the respirable size range containing infectious agents that remain infective over time and distance (eg, spores of aspergillus spp and m tuberculosis). microorganisms carried in this manner may be dispersed over long distances by air currents and may be inhaled by susceptible individuals who have not had face-to-face contact with (or even been in the same room with) the infectious individual. [ ] [ ] [ ] [ ] preventing the spread of pathogens that are transmitted by the airborne route requires the use of special air handling and ventilation systems (eg, aiirs) to contain and then safely remove the infectious agent. , infectious agents to which this applies include m tuberculosis, - rubeola virus (measles), and varicella-zoster virus (chickenpox). in addition, published data suggest the possibility that variola virus (smallpox) may be transmitted over long distances through the air under unusual circumstances, and aiirs are recommended for this agent as well; however, droplet and contact routes are the more frequent routes of transmission for smallpox. , , in addition to aiirs, respiratory protection with a national institute for occupational safety and health (niosh)-certified n or higher-level respirator is recommended for hcws entering the aiir, to prevent acquisition of airborne infectious agents such as m tuberculosis. for certain other respiratory infectious agents, such as influenza , and rhinovirus, and even some gastrointestinal viruses (eg, norovirus and rotavirus ) , there is some evidence that the pathogen may be transmitted through small-particle aerosols under natural and experimental conditions. such transmission has occurred over distances . feet but within a defined air space (eg, patient room), suggesting that it is unlikely that these agents remain viable on air currents that travel long distances. aiirs are not routinely required to prevent transmission of these agents. additional issues concerning small-particle aerosol transmission of agents that are most frequently transmitted by the droplet route are discussed below. although sars-cov is transmitted primarily by contact and/or droplet routes, airborne transmission over a limited distance (eg, within a room) has been suggested, although not proven. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] this is true of other infectious agents as well, such as influenza virus and noroviruses. , , influenza viruses are transmitted primarily by close contact with respiratory droplets, , and acquisition by hcws has been prevented by droplet precautions, even when positive-pressure rooms were used in one center. however, inhalational transmission could not be excluded in an outbreak of influenza in the passengers and crew of an aircraft. observations of a protective effect of ultraviolet light in preventing influenza among patients with tuberculosis during the influenza pandemic of - have been used to suggest airborne transmission. , in contrast to the strict interpretation of an airborne route for transmission (ie, long distances beyond the patient room environment), short-distance transmission by small-particle aerosols generated under specific circumstances (eg, during endotracheal intubation) to persons in the immediate area near the patient also has been demonstrated. aerosolized particles , mm in diameter can remain suspended in air when room air current velocities exceed the terminal settling velocities of the particles. sars-cov transmission has been associated with endotracheal intubation, noninvasive positive pressure ventilation, and cardiopulmonary resuscitation. , , , , although the most frequent routes of transmission of noroviruses are contact and foodborne and waterborne routes, several reports suggest that noroviruses also may be transmitted through aerosolization of infectious particles from vomitus or fecal material. , , , it is hypothesized that the aerosolized particles are inhaled and subsequently swallowed. roy this conceptual framework can explain rare occurrences of airborne transmission of agents that are transmitted most frequently by other routes (eg, smallpox, sars, influenza, noroviruses). concerns about unknown or possible routes of transmission of agents associated with severe disease and no known treatment often result in the adoption of overextreme prevention strategies, and recommended precautions may change as the epidemiology of an emerging infection becomes more well defined and controversial issues are resolved. i.b. .d.ii. transmission from the environment. some airborne infectious agents are derived from the environment and do not usually involve person-to-person transmission; for example, anthrax spores present in a finely milled powdered preparation can be aerosolized from contaminated environmental surfaces and inhaled into the respiratory tract. , spores of environmental fungi (eg, aspergillus spp) are ubiquitous in the environment and may cause disease in immunocompromised patients who inhale aerosolized spores (through, eg, construction dust). , as a rule, neither of these organisms is subsequently transmitted from infected patients; however, there is well-documented report of person-to-person transmission of aspergillus sp in the icu setting that was most likely due to the aerosolization of spores during wound debridement. the pe involves isolation practices designed to decrease the risk of exposure to environmental fungal agents in allogeneic hsct patients. , , , [ ] [ ] [ ] [ ] environmental sources of respiratory pathogens (eg, legionella) transmitted to humans through a common aerosol source is distinct from direct patient-to-patient transmission. i.b. .e. other sources of infection. sources of infection transmission other than infectious individuals include those associated with common environmental sources or vehicles (eg, contaminated food, water, or medications, such as intravenous fluids). although aspergillus spp have been recovered from hospital water systems, the role of water as a reservoir for immunosuppressed patients remains unclear. vectorborne transmission of infectious agents from mosquitoes, flies, rats, and other vermin also can occur in health care settings. prevention of vectorborne transmission is not addressed in this document. this section discusses several infectious agents with important infection control implications that either were not discussed extensively in previous isolation s vol. no. supplement guidelines or have emerged only recently. included are epidemiologically important organisms (eg, c difficile), agents of bioterrorism, prions, sars-cov, monkeypox, noroviruses, and the hemorrhagic fever viruses (hfvs). experience with these agents has broadened the understanding of modes of transmission and effective preventive measures. these agents are included for information purposes and, for some (ie, sars-cov, monkeypox), to highlight the lessons that have been learned about preparedness planning and responding effectively to new infectious agents. i.c. . epidemiologically important organisms. under defined conditions, any infectious agent transmitted in a health care setting may become targeted for control because it is epidemiologically important. c difficile is specifically discussed below because of its current prevalence and seriousness in us health care facilities. in determining what constitutes an ''epidemiologically important organism,'' the following criteria apply: d a propensity for transmission within health care facilities based on published reports and the occurrence of temporal or geographic clusters of more than patients, (eg, c difficile, norovirus, rsv, influenza, rotavirus, enterobacter spp, serratia spp, group a streptococcus). a single case of health care-associated invasive disease caused by certain pathogens (eg, group a streptococcus postoperatively, in a burn unit, or in a ltcf; legionella spp, , aspergillus spp ) is generally considered a trigger for investigation and enhanced control measures because of the risk of additional cases and the severity of illness associated with these infections. i.c. .a. clostridium difficile. c difficile is a sporeforming gram-positive anaerobic bacillus that was first isolated from stools of neonates in and identified as the most frequent causative agent of antibioticassociated diarrhea and pseudomembranous colitis in . this pathogen is a major cause of health care-associated diarrhea and has been responsible for many large outbreaks in health care settings that have proven extremely difficult to control. important factors contributing to health care-associated outbreaks include environmental contamination, persistence of spores for prolonged periods, resistance of spores to routinely used disinfectants and antiseptics, hand carriage by hcws to other patients, and exposure of patients to frequent courses of antimicrobial agents. antimicrobials most frequently associated with increased risk of c difficile include third-generation cephalosporins, clindamycin, vancomycin, and fluoroquinolones. since , outbreaks and sporadic cases of c difficile with increased morbidity and mortality have occurred in several us states, canada, england, and the netherlands. [ ] [ ] [ ] [ ] [ ] the same strain of c difficile has been implicated in all of these outbreaks; this strain, toxinotype iii, north american pulsedfield gel electrophoresis (pfge) type , and polymerase chain reaction (pcr)-ribotype (nap / ), has been found to hyperproduce toxin a (a -fold increase) and toxin b (a -fold increase) compared with isolates from other pfge types. a recent survey of us infectious disease physicians found that % of the respondents perceived recent increases in the incidence and severity of c difficile disease. standardization of testing methodology and surveillance definitions is needed for accurate comparisons of trends in rates among hospitals. it is hypothesized that the incidence of disease and apparent heightened transmissibility of this new strain may be due, at least in part, to the greater production of toxins a and b, increasing the severity of diarrhea and producing more environmental contamination. considering the greater morbidity, mortality, length of stay, and costs associated with c difficile disease in both acute care and long-term care facilities, control of this pathogen is becoming increasingly important. prevention of transmission focuses on syndromic application of contact precautions for patients with diarrhea, accurate identification of affected patients, environmental measures (eg, rigorous cleaning of patient rooms), and consistent hand hygiene. using soap and water rather than alcohol-based handrubs for mechanical removal of spores from hands and using a bleachcontaining disinfectant ( ppm) for environmental disinfection may be valuable in cases of transmission in health care facilities. appendix a provides for recommendations. i.c. .b. multidrug-resistant organisms. in general, mdros are defined as microorganisms-predominantly bacteria-that are resistant to or more classes of antimicrobial agents. although the names of certain mdros suggest resistance to only a single agent (eg, mrsa, vre), these pathogens are usually resistant to all but a few commercially available antimicrobial agents. this latter feature defines mdros that are considered to be epidemiologically important and deserve special attention in health care facilities. other mdros of current concern include multidrug-resistant streptococcus pneumoniae, which is resistant to penicillin and other broad-spectrum agents such as macrolides and fluroquinolones, multidrug-resistant gram-negative bacilli (mdr-gnb), especially those producing esbls; and strains of s aureus that are intermediate or resistant to vancomycin (ie, visa and vrsa). mdros are transmitted by the same routes as antimicrobial susceptible infectious agents. patient-to-patient transmission in health care settings, usually via hands of hcws, has been a major factor accounting for the increase in mdro incidence and prevalence, especially for mrsa and vre in acute care facilities. [ ] [ ] [ ] preventing the emergence and transmission of these pathogens requires a comprehensive approach that includes administrative involvement and measures (eg, nurse staffing, communication systems, performance improvement processes to ensure adherence to recommended infection control measures), education and training of medical and other hcws, judicious antibiotic use, comprehensive surveillance for targeted mdros, application of infection control precautions during patient care, environmental measures (eg, cleaning and disinfection of the patient care environment and equipment, dedicated single-patient use of noncritical equipment), and decolonization therapy when appropriate. the prevention and control of mdros is a national priority, one that requires that all health care facilities and agencies assume responsibility and participate in community-wide control programs. , a detailed discussion of this topic and recommendations for prevention published in is available at http:// www.cdc.gov/ncidod/dhqp/pdf/ar/mdroguideline . pdf. i.c. . agents of bioterrorism. the cdc has designated the agents that cause anthrax, smallpox, plague, tularemia, viral hemorrhagic fevers, and botulism as category a (high priority), because these agents can be easily disseminated environmentally and/or transmitted from person to person, can cause high mortality and have the potential for major public health impact, might cause public panic and social disruption, and necessitate special action for public health preparedness. general information relevant to infection control in health care settings for category a agents of bioterrorism is summarized in table . (see http:// www.bt.cdc.gov for additional, updated category a agent information as well as information concerning category b and c agents of bioterrorism and updates.) category b and c agents are important but are not as readily disseminated and cause less morbidity and mortality than category a agents. health care facilities confront a different set of issues when dealing with a suspected bioterrorism event compared with other communicable diseases. an understanding of the epidemiology, modes of transmission, and clinical course of each disease, as well as carefully drafted plans that specify an approach and relevant websites and other resources for disease-specific guidance to health care, administrative, and support personnel, are essential for responding to and managing a bioterrorism event. infection control issues to be addressed include ( ) identifying persons who may be exposed or infected; ( ) preventing transmission among patients, hcws, and visitors; ( ) providing treatment, chemoprophylaxis, or vaccine to potentially large numbers of people; ( ) protecting the environment, including the logistical aspects of securing sufficient numbers of aiirs or designating areas for patient cohorts when an insufficient number of aiirs is available; ( ) providing adequate quantities of appropriate ppe; and ( ) identifying appropriate staff to care for potentially infectious patients (eg, vaccinated hcws for care of patients with smallpox). the response is likely to differ for exposures resulting from an intentional release compared with a naturally occurring disease because of the large number of persons that can be exposed at the same time and possible differences in pathogenicity. various sources offer guidance for the management of persons exposed to the most likely agents of bioterrorism. federal agency websites (eg, http://www. usamriid.army.mil/publications/index.html and http:// www.bt.cdc.gov) and state and county health department websites should be consulted for the most upto-date information. sources of information on specific agents include anthrax, smallpox, [ ] [ ] [ ] plague, , botulinum toxin, tularemia, and hemorrhagic fever viruses. , i.c. .a. pre-event administration of smallpox (vaccinia) vaccine to health care workers. vaccination of hcwsl in preparation for a possible smallpox exposure has important infection control implications. [ ] [ ] [ ] these include the need for meticulous screening for vaccine contraindications in persons at increased risk for adverse vaccinia events; containment and monitoring of the vaccination site to prevent transmission in the health care setting and at home; and management of patients with vaccinia-related adverse events. , the pre-event us smallpox vaccination program of is an example of the effectiveness of carefully developed recommendations for both screening potential vaccinees for contraindications and vaccination site care and monitoring. between december and february , approximately , individuals were vaccinated in the department of defense and , in the civilian or public health populations, including approximately , who worked in health care settings. no cases of eczema vaccinatum, progressive vaccinia, fetal vaccinia, or contact transfer of vaccinia were reported in health care settings or in military workplaces. , outside the health care setting, there were cases of contact transfer from military vaccinees to close personal contacts (eg, bed partners or contacts during participation in sports such as wrestling ). all contact transfers were from individuals who were not following recommendations to cover their vaccination sites. vaccinia virus was confirmed by culture or pcr in cases, of which resulted from tertiary transfer. all recipients, including breast-fed infant, recovered without complications. subsequent studies using viral culture and pcr techniques have confirmed the effectiveness of semipermeable dressings to contain vaccinia. [ ] [ ] [ ] [ ] this experience emphasizes the importance of ensuring that newly vaccinated hcws adhere to recommended vaccination site care, especially those caring for high-risk patients. recommendations for pre-event smallpox vaccination of hcws and vacciniarelated infection control recommendations are published in the morbidity and mortality weekly report, , with updates posted on the cdc's bioterrorism website. i.c. . prions. creutzfeldt-jakob disease (cjd) is a rapidly progressive, degenerative neurologic disorder of humans, with an incidence in the united states of approximately person/million population/year. , cjd is believed to be caused by a transmissible proteinaceous infectious agent known as a prion. infectious prions are isoforms of a host-encoded glycoprotein known as the prion protein. the incubation period (ie, time between exposure and and onset of symptoms) varies from years to many decades. however, death typically occurs within year of the onset of symptoms. approximately % of cjd cases occur sporadically with no known environmental source of infection, and % of cases are familial. iatrogenic transmission has occurred, with most cases resulting from treatment with human cadaver pituitary-derived growth hormone or gonadotropin, , from implantation of contaminated human dura mater grafts, or from corneal transplants. transmission has been linked to the use of contaminated neurosurgical instruments or stereotactic electroencephalogram electrodes. [ ] [ ] [ ] [ ] prion diseases in animals include scrapie in sheep and goats, bovine spongiform encephalopathy (bse, or ''mad cow disease'') in cattle, and chronic wasting disease in deer and elk. bse, first recognized in the united kingdom in , was associated with a major epidemic among cattle that had consumed contaminated meat and bone meal. the possible transmission of bse to humans causing variant cjd (vcjd) was first described in and was subsequently found to be associated with consumption of bse-contaminated cattle products primarily in the united kingdom. there is strong epidemiologic and laboratory evidence for a causal association between the causative agent of bse and vcjd. although most cases of vcjd have been reported from the united kingdom, a few cases also have been reported from europe, japan, canada, and the united states. most persons affected with vcjd worldwide lived in or visited the united kingdom during the years of a large outbreak of bse ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) and may have consumed contaminated cattle products during that time (see http://www.cdc.gov/ncidod/ diseases/cjd/cjd.htm). although there has been no indigenously acquired vcjd in the united states, the sporadic occurrence of bse in cattle in north america has heightened awareness of the possibility that such infections could occur and have led to increased surveillance activities. updated information may be found at http://www.cdc.gov/ncidod/diseases/cjd/cjd.htm. the public health impact of prion diseases has been reviewed previously. vcjd in humans has different clinical and pathologic characteristics than sporadic or classic cjd, including ( ) younger median age at death ( [range, to ] vs years), ( ) longer median duration of illness ( months vs to months), ( ) increased frequency of sensory symptoms and early psychiatric symptoms with delayed onset of frank neurologic signs; and ( ) detection of prions in tonsillar and other lymphoid tissues, not present in sporadic cjd. similar to sporadic cjd, there have been no reported cases of direct human-tohuman transmission of vcjd by casual or environmental contact, droplet, or airborne routes. ongoing blood safety surveillance in the united states has not detected sporadic cjd transmission through blood transfusion; - however, bloodborne transmission of vcjd is believed to have occurred in patients in the uited kingdom. , the following fda websites provide information on steps currently being taken in the united states to protect the blood supply from cjd and vcjd: http://www.fda.gov/cber/gdlns/cjdvcjd.htm and http:// www.fda.gov/cber/gdlns/cjdvcjdq&a.htm. standard precautions are used when caring for patients with suspected or confirmed cjd or vcjd. however, special precautions are recommended for tissue handling in the histology laboratory and for conducting an autopsy, embalming, and coming into contact with a body that has undergone autopsy. recommendations for reprocessing surgical instruments to prevent transmission of cjd in health care settings have been published by the world health organization (who) and are currently under review at the cdc. questions may arise concerning notification of patients potentially exposed to cjd or vcjd through contaminated instruments and blood products from patients with cjd or vcjd or at risk of having vcjd. the risk of transmission associated with such exposures is believed to be extremely low but may vary based on the specific circumstance. therefore, consultation on appropriate options is advised. the united kingdom has developed several documents that clinicians and patients in the united states may find useful (see http://www.hpa.org.uk/infections/topics_az/cjd/ information_documents.htm). i.c. . severe acute respiratory syndrome. sars is a newly discovered respiratory disease that emerged in china late in and spread to several countries. , in particular, mainland china, hong kong, hanoi, singapore, and toronto have been significantly affected. sars is caused by sars-cov, a previously unrecognized member of the coronavirus family. , the incubation period from exposure to the onset of symptoms is typically to days, but can be as long as days and in rare cases even longer. the illness is initially difficult to distinguish from other common respiratory infections. signs and symptoms usually include fever above . c and chills and rigors, sometimes accompanied by headache, myalgia, and mild to severe respiratory symptoms. a radiographic profile of atypical pneumonia is an important clinical indicator of possible sars. compared with adults, children are affected less frequently, have milder disease, and are less likely to transmit sars-cov. , [ ] [ ] [ ] the overall case fatality rate is approximately %; underlying disease and advanced age increase the risk of mortality (see http://www.who.int/csr/sarsarchive/ _ _ a/en/). outbreaks in health care settings, with transmission to large numbers of hcws and patients, haa been a striking feature of sars; undiagnosed infectious patients and visitors have been important initiators of these outbreaks. , [ ] [ ] [ ] the relative contribution of potential modes of transmission is not known precisely. there is ample evidence for droplet and contact transmission; , , however, opportunistic airborne transmission cannot be excluded. , [ ] [ ] [ ] [ ] [ ] , for example, exposure to aerosol-generating procedures (eg, endotracheal intubation, suctioning) has been associated with transmission of infection to large numbers of hcws outside of the united states. , , , , therefore, aerosolization of small infectious particles generated during these and other similar procedures could be a risk factor for transmission to others within a multibed room or shared airspace. a review of the infection control literature generated from the sars outbreaks of concluded that the greatest risk of transmission is to those who have close contact, are not properly trained in use of protective infection control procedures, and do not consistently use ppe, and that n or higher-level respirators may offer additional protection to those exposed to aerosol-generating procedures and high-risk activities. , organizational and individual factors that affect adherence to infection control practices for sars also were identified. control of sars requires a coordinated, dynamic response by multiple disciplines in a health care setting. early detection of cases is accomplished by screening persons with symptoms of a respiratory infection for history of travel to areas experiencing community transmission or contact with sars patients, followed by implementation of respiratory hygiene/cough etiquette (ie, placing a mask over the patient's nose and mouth) and physical separation from other patients in common waiting areas. the precise combination of precautions to protect hcws has not yet been determined. at the time of this publication, the cdc recommends standard precautions, with emphasis on the use of hand hygiene; contact precautions, with emphasis on environmental cleaning due to the detection of sars-cov rna by pcr on surfaces in rooms occupied by sars patients; , , and airborne precautions, including use of fit-tested niosh-approved n or higher-level respirators and eye protection. in hong kong, the use of droplet and contact precautions, including the use of a mask but not a respirator, was effective in protecting hcws. however, in toronto, consistent use of an n respirator was found to be slightly more protective than a mask. it is noteworthy that no transmission of sars-cov to public hospital workers occurred in vietnam despite inconsistent use of infection control measures, including use of ppe, which suggests other factors (eg, severity of disease, frequency of high-risk procedures or events, environmental features) may influence opportunities for transmission. sars-cov also has been transmitted in the laboratory setting through breaches in recommended laboratory practices. research laboratories in which sars-cov was under investigation were the source of most cases reported after the first series of outbreaks in the winter and spring of . lessons learned from the sars outbreaks are useful in devising plans to respond to future public health crises, such as pandemic influenza and bioterrorism events. surveillance for cases among patients and hcws, ensuring availability of adequate supplies and staffing, and limiting access to health care facilities were important factors in the response to sars. guidance for infection control precautions in various settings is available at http://www.cdc.gov/ncidod/sars. i.c. . monkeypox. monkeypox is a rare viral disease found mostly in the rain forest countries of central and west africa. the disease is caused by an orthopoxvirus that is similar in appearance to smallpox but causes a milder disease. the only recognized outbreak of human monkeypox in the united states was detected in june , after several people became ill after contact with sick pet prairie dogs. infection in the prairie dogs was subsequently traced to their contact with a shipment of animals from africa, including giant gambian rats. this outbreak demonstrates the importance of recognition and prompt reporting of unusual disease presentations by clinicians to enable prompt identification of the etiology, as well as the potential of epizootic diseases to spread from animal reservoirs to humans through personal and occupational exposure. only limited data on transmission of monkeypox are available. transmission from infected animals and humans is believed to occur primarily through direct contact with lesions and respiratory secretions; airborne transmission from animals to humans is unlikely but cannot be excluded, and may have occurred in veterinary practices (eg, during administration of nebulized medications to ill prairie dogs ). in humans, instances of monkeypox transmission in hospitals have been reported in africa among children, usually related to sharing the same ward or bed. , additional recent literature documents transmission of congo basin monkeypox in a hospital compound for an extended number of generations. there has been no evidence of airborne or any other person-to-person transmission of monkeypox in the united states, and no new cases of monkeypox have been identified since the outbreak in june . the outbreak strain is a clade of monkeypox distinct from the congo basin clade and may have different epidemiologic properties (including human-to-human transmission potential) from monkeypox strains of the congo basin; this awaits further study. smallpox vaccine is % protective against congo basin monkeypox. because there is an associated case fatality rate of , %, administration of smallpox vaccine within days to individuals who have had direct exposure to patients or animals with monkeypox is a reasonable policy. for the most current information on monkeypox, see http://www.cdc.gov/ncidod/mon keypox/clinicians.htm. i.c. . noroviruses. noroviruses, formerly referred to as norwalk-like viruses, are members of the caliciviridae family. these agents are transmitted via contaminated food or water and from person to person, causing explosive outbreaks of gastrointestinal disease. environmental contamination also has been documented as a contributing factor in ongoing transmission during outbreaks. , although noroviruses cannot be propagated in cell culture, dna detection by molecular diagnostic techniques has brought a greater appreciation of their role in outbreaks of gastrointestinal disease. reported outbreaks in hospitals, and large crowded shelters established for hurricane evacuees has demonstrated their highly contagious nature, their potentially disruptive impact in health care facilities and the community, and the difficulty of controlling outbreaks in settings in which people share common facilites and space. of note, there is nearly a -fold increase in the risk to patients in outbreaks when a patient is the index case compared with exposure of patients during outbreaks when a staff member is the index case. the average incubation period for gastroenteritis caused by noroviruses is to hours, and the clinical course lasts to hours. illness is characterized by acute onset of nausea, vomiting, abdominal cramps, and/or diarrhea. the disease is largely self-limited; rarely, death due to severe dehydration can occur, particularly in elderly persons with debilitating health conditions. the epidemiology of norovirus outbreaks shows that even though primary cases may result from exposure to a fecally contaminated food or water, secondary and tertiary cases often result from person-to-person transmission facilitated by contamination of fomites , and dissemination of infectious particles, especially during the process of vomiting. , , , , , , , widespread, persistent, and inapparent contamination of the environment and fomites can make outbreaks extremely difficult to control. , , these clinical observations and the detection of norovirus dna on horizontal surfaces feet above the level that might be touched normally suggest that under certain circumstances, aerosolized particles may travel distances beyond feet. it is hypothesized that infectious particles may be aerosolized from vomitus, inhaled, and swallowed. in addition, individuals who are responsible for cleaning the environment may be at increased risk of infection. development of disease and transmission may be facilitated by the low infectious dose (ie, , viral particles) and the resistance of these viruses to the usual cleaning and disinfection agents (ie, they may survive , ppm chlorine). [ ] [ ] [ ] an alternate phenolic agent that was shown to be effective against feline calicivirus was used for environmental cleaning in one outbreak. , there are insufficient data to determine the efficacy of alcohol-based hand rubs against noroviruses when the hands are not visibly soiled. absence of disease in certain individuals during an outbreak may be explained by protection from infection conferred by the b histo-blood group antigen. consultation on outbreaks of gastroenteritis is available through the cdc's division of viral and rickettsial diseases. i.c. . hemorrhagic fever viruses. hfv is a mixed group of viruses that cause serious disease with high fever, skin rash, bleeding diathesis, and, in some cases, high mortality; the resulting disease is referred to as viral hemorrhagic fever (vhf). among the more commonly known hfvs are ebola and marburg viruses (filoviridae), lassa virus (arenaviridae), crimean-congo hemorrhagic fever and rift valley fever virus (bunyaviridae), and dengue and yellow fever viruses (flaviviridae). , these viruses are transmitted to humans through contact with infected animals or via arthropod vectors. although none of these viruses is endemic in the united states, outbreaks in affected countries provide potential opportunities for importation by infected humans and animals. furthermore, there is a concern that some of these agents could be used as bioweapons. person-to-person transmission has been documented for ebola, marburg, lassa, and crimean-congo hfvs. in resource-limited health care settings, transmission of these agents to hcws, patients, and visitors has been described and in some outbreaks has accounted for a large proportion of cases. [ ] [ ] [ ] transmission within households also has been documented in individuals who had direct contact with ill persons or their body fluids, but not in those who did not have such contact. evidence concerning the transmission of hfvs has been summarized previously. , person-to-person transmission is associated primarily with direct blood and body fluid contact. percutaneous exposure to contaminated blood carries a particularly high risk for transmission and increased mortality. , the finding of large numbers of ebola viral particles in the skin and the lumina of sweat glands has raised concerns that transmission could occur from direct contact with intact skin, although epidemiologic evidence to support this is lacking. postmortem handling of infected bodies is an important risk for transmission. , , in rare situations, cases in which the mode of transmission was unexplained among individuals with no known direct contact have led to speculation that airborne transmission could have occurred. however, airborne transmission of naturally occurring hfvs in humans has not been documented. a study of airplane passengers exposed to an in-flight index case of lassa fever found no transmission to any passengers. in the laboratory setting, animals have been infected experimentally with marburg or ebola virus through direct inoculation of the nose, mouth, and/or conjunctiva , and by using mechanically generated viruscontaining aerosols. , transmission of ebola virus among laboratory primates in an animal facility has been described. the secondarily infected animals were in individual cages separated by approximately meters. although the possibility of airborne transmission was suggested, the investigators were not able to exclude droplet or indirect contact transmission in this incidental observation. guidance on infection control precautions for hvfs transmitted person-to-person have been published by the cdc , and by the johns hopkins center for civilian biodefense strategies. the most recent recommendations at the time of publication of this document were posted on the cdc website on may , . inconsistencies among the various recommendations have raised questions about the appropriate precautions to use in us hospitals. in less developed countries, outbreaks of hfvs have been controlled with basic hygiene, barrier precautions, safe injection practices, and safe burial practices. , the preponderance of evidence on hfv transmission indicates that standard, contact, and droplet precautions with eye protection are effective in protecting hcws and visitors coming in contact with an infected patient. single gloves are adequate for routine patient care; doublegloving is advised during invasive procedures (eg, surgery) that pose an increased risk of blood exposure. routine eye protection (ie goggles or face shield) is particularly important. fluid-resistant gowns should be worn for all patient contact. airborne precautions are not required for routine patient care; however, use of aiirs is prudent when procedures that could generate infectious aerosols are performed (eg, endotracheal intubation, bronchoscopy, suctioning, autopsy procedures involving oscillating saws). n or higher-level respirators may provide added protection for individuals in a room during aerosol-generating procedures ( table , appendix a). when a patient with a syndrome consistent with hemorrhagic fever also has a history of travel to an endemic area, precautions are initiated on presentation and then modified as more information is obtained ( table ) . patients with hemorrhagic fever syndrome in the setting of a suspected bioweapons attack should be managed using airborne precautions, including aiirs, because the epidemiology of a potentially weaponized hemorrhagic fever virus is unpredictable. numerous factors influence differences in transmission risks among the various health care settings. these factors include the population characteristics (eg, increased susceptibility to infections, type and prevalence of indwelling devices), intensity of care, exposure to environmental sources, length of stay, and frequency of interaction between patients/residents with each other and with hcws. these factors, as well as organizational priorities, goals, and resources, influence how different health care settings adapt transmission prevention guidelines to meet their specific needs. , infection control management decisions are informed by data regarding institutional experience/epidemiology; trends in community and institutional hais; local, regional, and national epidemiology; and emerging infectious disease threats. i.d. . hospitals. infection transmission risks are present in all hospital settings. however, certain hospital settings and patient populations have unique conditions that predispose patients to infection and merit special mention. these are often sentinel sites for the emergence of new transmission risks that may be unique to that setting or present opportunities for transmission to other settings in the hospital. i.d. .a. intensive care units. intensive care units (icus) serve patients who are immunocompromised by disease state and/or by treatment modalities, as well as patients with major trauma, respiratory failure, and other life-threatening conditions (eg, myocardial infarction, congestive heart failure, overdose, stroke, gastrointestinal bleeding, renal failure, hepatic failure, multiorgan system failure, and extremes of age). although icus account for a relatively small proportion of hospitalized patients, infections acquired in these units account for . % of all hais. in the national nosocomial infection surveillance (nnis) system, . % of hais were reported from icu and high-risk nursery (neonatal icu [nicu]) patients in (nnis, unpublished data). this patient population has increased susceptibility to colonization and infection, especially with mdros and candida spp, , because of underlying diseases and conditions, the invasive medical devices and technology used in their care (eg central venous catheters and other intravascular devices, mechanical ventilators, extracorporeal membrane oxygenation, hemodialysis/filtration, pacemakers, implantable left-ventricular assist devices), the frequency of contact with hcws, prolonged lengths of stay, and prolonged exposure to antimicrobial agents. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] furthermore, adverse patient outcomes in this setting are more severe and are associated with a higher mortality. outbreaks associated with various bacterial, fungal, and viral pathogens due to common-source and person-to-person transmissions are frequent in adult icus and pediatric icus (picus). , [ ] [ ] [ ] [ ] [ ] [ ] i.d. .b. burn units. burn wounds can provide optimal conditions for colonization, infection, and transmission of pathogens; infection acquired by burn patients is a frequent cause of morbidity and mortality. , , the risk of invasive burn wound infection is particularly high in patients with a burn injury involving . % of the total body surface area (tbsa). , infections occurring in patients with burn injuries involving , % of the tbsa are usually associated with the use of invasive devices. mssa, mrsa, enterococci (including vre), gram-negative bacteria, and candida spp are prevalent pathogens in burn infections, , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] and outbreaks of these organisms have been reported. [ ] [ ] [ ] [ ] shifts over time in the predominance of pathogens causing infections in burn patients often lead to changes in burn care practices. , [ ] [ ] [ ] [ ] burn wound infections caused by aspergillus spp or other environmental molds may result from exposure to supplies contaminated during construction or to dust generated during construction or other environmental disruption. hydrotherapy equipment is an important environmental reservoir of gram-negative organisms. its use in burn care is discouraged based on demonstrated associations between the use of contaminated hydrotherapy equipment and infections. burn wound infections and colonization, as well as bloodstream infections, caused by multidrug-resistant p aeruginosa, acinetobacter baumannii, and mrsa have been associated with hydrotherapy; thus, excision of burn wounds in operating rooms is the preferred approach. advances in burn care (specifically, early excision and grafting of the burn wound, use of topical antimicrobial agents, and institution of early enteral feeding) have led to decreased infectious complications. other advances have included prophylactic antimicrobial use, selective digestive decontamination, and use of antimicrobial-coated catheters; however, few epidemiologic studies and no efficacy studies have been performed to investigate the relative benefit of these measures. there is no consensus on the most effective infection control practices to prevent transmission of infections to and from patients with serious burns (eg, single-bed rooms, laminar flow, and high-efficiency particulate air [hepa] filtration, or maintaining burn patients in a separate unit with no exposure to patients or equipment from other units ). there also is controversy regarding the need for and type of barrier precautions in the routine care of burn patients. one retrospective study demonstrated the efficacy and cost-effectiveness of a simplified barrier isolation protocol for wound colonization, emphasizing handwashing and use of gloves, caps, masks, and impermeable plastic aprons (rather than isolation gowns) for direct patient contact. however, to date no studies have determined the most effective combination of infection control precautions for use in burn settings. prospective studies in this area are needed. i.d. .c. pediatrics. studies of the epidemiology of hais in children have identified unique infection control issues in this population. , , [ ] [ ] [ ] [ ] [ ] pediatric icu patients and the lowest birth weight babies in the nicu monitored in the nnis system have had high rates of central venous catheter-associated bloodstream infections. , ) . close physical contact between hcws and infants and young children (eg. cuddling, feeding, playing, changing soiled diapers, and cleaning copious uncontrolled respiratory secretions) provides abundant opportunities for transmission of infectious material. such practices and behaviors as congregation of children in play areas where toys and bodily secretions are easily shared and rooming-in of family members with pediatric patients can further increase the risk of transmission. pathogenic bacteria have been recovered from toys used by hospitalized patients; contaminated bath toys were implicated in an outbreak of multidrug-resistant p. aeruginosa on a pediatric oncology unit. in addition, several patient factors increase the likelihood that infection will result from exposure to pathogens in health care settings (eg, immaturity of the neonatal immune system, lack of previous natural infection and resulting immunity, prevalence of patients with congenital or acquired immune deficiencies, congenital anatomic anomalies, and use of life-saving invasive devices in nicus and picus). there are theoretical concerns that infection risk will increase in association with innovative practices used in the nicu for the purpose of improving developmental outcomes, such factors include cobedding and kangaroo care, which may increase opportunity for skin-to-skin exposure of multiple gestation infants to each other and to their mothers, respectively; although the risk of infection actually may be reduced among infants receiving kangaroo care. children who attend child care centers , and pediatric rehabilitation units may increase the overall burden of antimicrobial resistance by contributing to the reservoir of ca-mrsa. [ ] [ ] [ ] [ ] [ ] [ ] patients in chronic care facilities may have increased rates of colonization with resistant garm-negative bacilli and may be sources of introduction of resistant organisms to acute care settings. i.d. . nonacute health care settings. health care is provided in various settings outside of hospitals, including long-term care facilities (ltcfs) (eg nursing homes), homes for the developmentally disabled, behavioral health service settings, rehabilitation centers, and hospices. in addition, health care may be provided in non-health care settings, such as workplaces with occupational health clinics, adult day care centers, assisted-living facilities, homeless shelters, jails and prisons, school clinics, and infirmaries. each of these settings has unique circumstances and population risks that must be considered when designing and implementing an infection control program. several of the most common settings and their particular challenges are discussed below. although this guideline does not address each setting, the principles and strategies provided herein may be adapted and applied as appropriate. i.d. .a. long-term care. the designation ltcf applies to a diverse group of residential settings, ranging from institutions for the developmentally disabled to nursing homes for the elderly and pediatric chronic care facilities. [ ] [ ] [ ] nursing homes for the elderly predominate numerically and frequently represent longterm care as a group of facilities. approximately . million americans reside in the nation's , nursing homes. estimates of hai rates of . to . per resident-care days have been reported, with a range of to per resident-care days in the more rigorous studies. [ ] [ ] [ ] [ ] [ ] the infrastructure described in the department of veterans affairs' nursing home care units is a promising example for the development of a nationwide hai surveillance system for ltcfs. lctfs are different from other health care settings in that elderly patients at increased risk for infection are brought together in one setting and remain in the facility for extended periods; for most residents, it is their home. an atmosphere of community is fostered, and residents share common eating and living areas and participate in various facility-sponsored activities. , because able residents interact freely with each other, controlling infection transmission in this setting can be challenging. a residents who is colonized or infected with certain microorganisms are in some cases restricted to his or her room. however, because of the psychosocial risks associated with such restriction, balancing psychosocial needs with infection control needs is important in the ltcf setting. , , , ) and bacteria, including group a streptococcus, , b pertussis, nonsusceptible s pneumoniae, , other mdros, and c difficile ). these pathogens can lead to substantial morbidity and mortality, as well as increased medical costs; prompt detection and implementation of effective control measures are needed. risk factors for infection are prevalent among ltcf residents. , , age-related declines in immunity may affect the response to immunizations for influenza and other infectious agents and increase the susceptibility to tuberculosis. immobility, incontinence, dysphagia, underlying chronic diseases, poor functional status, and age-related skin changes increase susceptibility to urinary, respiratory, and cutaneous and soft tissue infections, whereas malnutrition can impair wound healing. [ ] [ ] [ ] [ ] [ ] medications (eg, drugs that affect level of consciousness, immune function, gastric acid secretions, and normal flora, including antimicrobial therapy) and invasive devices (eg, urinary catheters and feeding tubes) heighten the susceptibility to infection and colonization in ltcf residents. [ ] [ ] [ ] finally, limited functional status and total dependence on hcws for activities of daily living have been identified as independent risk factors for infection , , and for colonization with mrsa , and esbl-producing klebsiella pneumoniae. several position papers and review articles provide guidance on various aspects of infection control and antimicrobial resistance in ltcfs. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] the centers for medicare and medicaid services has established regulations for the prevention of infection in ltcfs. because residents of ltcfs are hospitalized frequently, they can transfer pathogens between ltcfs and health care facilities in which they receive care. , [ ] [ ] [ ] [ ] this also is true for pediatric long-term care populations. pediatric chronic care facilities have been associated with the importation of extendedspectrum cephalosporin-resistant, gram-negative bacilli into a picu. children from pediatric rehabilitation units may contribute to the reservoir of community-associated mrsa. , [ ] [ ] [ ] i.d. .b. ambulatory care. over the past decade, health care delivery in the united states has shifted from the acute, inpatient hospital to various ambulatory and community-based settings, including the home. ambulatory care is provided in hospital-based outpatient clinics, nonhospital-based clinics and physicians' offices, public health clinics, free-standing dialysis centers, ambulatory surgical centers, urgent care centers, and other setting. in , there were million visits to hospital outpatient clinics and more than million visits to physicians' offices; ambulatory care now accounts for most patient encounters with the health care system. adapting transmission prevention guidelines to these settings is challenging, because patients remain in common areas for prolonged periods waiting to be seen by a health care provider or awaiting admission to the hospital, examination or treatment rooms are turned around quickly with limited cleaning, and infectious patients may not be recognized immediately. furthermore, immunocompromised patients often receive chemotherapy in infusion rooms, where they stay for extended periods along with other types of patients. little data exist on the risk of hais in ambulatory care settings, with the exception of hemodialysis centers. , , transmission of infections in outpatient settings has been reviewed in studies. [ ] [ ] [ ] goodman and solomon summarized clusters of infections associated with the outpatient setting between and . overall, clusters were associated with common source transmission from contaminated solutions or equipment, were associated with person-to-person transmission from or involving hcws, and were associated with airborne or droplet transmission among patients and health care workers. transmission of bloodborne pathogens (ie, hbv, hcv, and, rarely, hiv) in outbreaks, sometimes involving hundreds of patients, continues to occur in ambulatory settings. these outbreaks often are related to common source exposures, usually a contaminated medical device, multidose vial, or intravenous solution. , [ ] [ ] [ ] [ ] [ ] in all cases, transmission has been attributed to failure to adhere to fundamental infection control principles, including safe injection practices and aseptic technique. this subject has been reviewed, and recommended infection control and safe injection practices have been summarized. airborne transmission of m tuberculosis and measles in ambulatory settings, most often emergency departments, has been reported. , , , , [ ] [ ] [ ] measles virus was transmitted in physicians' offices and other outpatient settings during an era when immunization rates were low and measles outbreaks in the community were occurring regularly. , , rubella has been transmitted in the outpatient obstetric setting; there are no published reports of varicella transmission in the outpatient setting. in the ophthalmology setting, adenovirus type epidemic keratoconjunctivitis has been transmitted through incompletely disinfected ophthalmology equipment and/or from hcws to patients, presumably by contaminated hands. , , , [ ] [ ] [ ] [ ] preventing transmission in outpatient settings necessitates screening for potentially infectious symptomatic and asymptomatic individuals, especially those at possible risk for transmitting airborne infectious agents (eg, m tuberculosis, varicella-zoster virus, rubeola [measles]), at the start of the initial patient encounter. on identification of a potentially infectious patient, implementation of prevention measures, including prompt separation of potentially infectious patients and implementation of appropriate control measures (eg, respiratory hygiene/cough etiquette and transmission-based precautions) can decrease transmission risks. , transmission of mrsa and vre in outpatient settings has not been reported, but the association of ca-mrsa in hcws working in an outpatient hiv clinic with environmental ca-mrsa contamination in that clinic suggests the possibility of transmission in that setting. patient-to-patient transmission of burkholderia spp and p aeruginosa in outpatient clinics for adults and children with cystic fibrosis has been confirmed. , i.d. .c. home care. home care in the united states is delivered by more than , provider agencies, including home health agencies, hospices, durable medical equipment providers, home infusion therapy services, and personal care and support services providers. home care is provided to patients of all ages with both acute and chronic conditions. the scope of services ranges from assistance with activities of daily living and physical and occupational therapy to the care of wounds, infusion therapy, and chronic ambulatory peritoneal dialysis. the incidence of infection in home care patients, other than that associated with infusion therapy, has not been well studied. [ ] [ ] [ ] [ ] [ ] [ ] however, data collection and calculation of infection rates have been done for central venous catheter-associated bloodstream infections in patients receiving home infusion therapy [ ] [ ] [ ] [ ] [ ] and for the risk of blood contact through percutaneous or mucosal exposures, demonstrating that surveillance can be performed in this setting. draft definitions for home care-associated infections have been developed. transmission risks during home care are presumed to be minimal. the main transmission risks to home care patients are from an infectious home care provider or contaminated equipment; a provider also can be exposed to an infectious patient during home visits. because home care involves patient care by a limited number of personnel in settings without multiple patients or shared equipment, the potential reservoir of pathogens is reduced. infections of home care providers that could pose a risk to home care patients include infections transmitted by the airborne or droplet routes (eg, chickenpox, tuberculosis, influenza), skin infestations (eg, scabies and lice), and infections transmitted by direct or indirect contact (eg, impetigo). there are no published data on indirect transmission of mdros from one home care patient to another, although this is theoretically possible if contaminated equipment is transported from an infected or colonized patient and used on another patient. of note, investigations of the first case of visa in home care and the first reported cases of vrsa , , , found no evidence of transmission of visa or vrsa to other home care recipients. home health care also may contribute to antimicrobial resistance; a review of outpatient vancomycin use found that % of recipients did not receive prescribed antibiotics according to recommended guidelines. although most home care agencies implement policies and procedures aimed at preventing transmission of organisms, the current approach is based on the adaptation of the guideline for isolation precautions in hospitals, as well as other professional guidance. , this issue has proven very challenging to the home care industry, and practice has been inconsistent and frequently not evidence-based. for example, many home health agencies continue to observe ''nursing bag technique,'' a practice that prescribes the use of barriers between the nursing bag and environmental surfaces in the home. although the home environment may not always appear clean, the use of barriers between noncritical surfaces has been questioned. , opportunites exist to conduct research in home care related to infection transmission risks. i.d. .d. other sites of health care delivery. facilities that are not primarily health care settings but in which health care is delivered include clinics in correctional facilities and shelters. both of these settings can have suboptimal features, such as crowded conditions and poor ventilation. economically disadvantaged individuals who may have chronic illnesses and health care problems related to alcoholism, injected drug use, poor nutrition, and/or inadequate shelter often receive their primary health care at such sites. infectious diseases of special concern for transmission include tuberculosis, scabies, respiratory infections (eg, n meningitides, s pneumoniae), sexually transmitted and bloodborne diseases (eg, hiv, hbv, hcv, syphilis, gonorrhea), hepatitis a virus, diarrheal agents such as norovirus, and foodborne diseases. , [ ] [ ] [ ] [ ] a high index of suspicion for tuberculosis and ca-mrsa in these populations is needed; outbreaks in these settings or among the populations they serve have been reported. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] patient encounters in these types of facilities provide an opportunity to deliver recommended immunizations and screen for m tuberculosis infection, along with diagnosing and treating acute illnesses. recommended infection control measures in these nontraditional areas designated for health care delivery are the same as for other ambulatory care settings. therefore, these settings must be equipped to observe standard precautions and, when indicated, transmission-based precautions. as new treatments emerge for complex diseases, unique infection control challenges associated with special patient populations must be addressed. i.e. . immunocompromised patients. patients who have congenital primary immune deficiencies or acquired disease (eg. treatment-induced immune deficiencies) are at increased risk for numerous types of infections while receiving health care; these patients may be located throughout the health care facility. the specific immune system defects determine the types of infections most likely to be acquired (eg, viral infections are associated with t cell defects, and fungal and bacterial infections occur in patients who are neutropenic). as a general group, immunocompromised patients can be cared for in the same environment as other patients; however, it is always advisable to minimize exposure to other patients with transmissible infections, such as influenza and other respiratory viruses. , the use of more intense chemotherapy regimens for treatment of childhood leukemia may be associated with prolonged periods of neutropenia and suppression of other components of the immune system, extending the period of infection risk and raising the concern that additional precautions may be indicated for select groups. , with the application of newer and more intense immunosuppressive therapies for various medical conditions (eg, rheumatologic disease, , inflammatory bowel disease ), immunosuppressed patients are likely to be more widely distributed throughout a health care facility rather than localized to single patient units (eg, hematologyoncology). guidelines for preventing infections in certain groups of immunocompromised patients have been published previously. , , published data provide evidence to support placing patients undergoing allogeneic hsct in a pe. , , in addition, guidelines have been developed that address the special requirements of these immunocompromised patients, including use of antimicrobial prophylaxis and engineering controls to create a pe for the prevention of infections caused by aspergillus spp and other environmental fungi. , , as more intense chemotherapy regimens associated with prolonged periods of neutropenia or graft-versus-host disease are implemented, the period of risk and duration of environmental protection may need to be prolonged beyond the traditional days. i.e. . cystic fibrosis patients. patients with cystic fibrosis (cf) require special consideration when developing infection control guidelines. compared with other patients, cf patients require additional protection to prevent transmission from contaminated respiratory therapy equipment. [ ] [ ] [ ] [ ] [ ] such infectious agents as b cepacia complex and p aeruginosa. , , , have unique clinical and prognostic significance. in cf patients, b cepacia infection has been associated with increased morbidity and mortality, [ ] [ ] [ ] whereas delayed acquisition of chronic p aeruginosa infection may be associated with an improved long-term clinical outcome. , person-to-person transmission of b cepacia complex has been demonstrated among children and adults with cf in health care settings , and from various social contacts, most notably attendance at camps for patients with cf and among siblings with cf. successful infection control measures used to prevent transmission of respiratory secretions include segregation of cf patients from each other in ambulatory and hospital settings (including use of private rooms with separate showers), environmental decontamination of surfaces and equipment contaminated with respiratory secretions, elimination of group chest physiotherapy sessions, and disbanding of cf camps. , the cystic fibrosis foundation has published a consensus document with evidence-based recommendations for infection control practices in cf patients. i.f. new therapies associated with potentially transmissible infectious agents i.f. . gene therapy. gene therapy has has been attempted using various viral vectors, including nonreplicating retroviruses, adenoviruses, adeno-associated viruses, and replication-competent strains of poxviruses. unexpected adverse events have restricted the prevalence of gene therapy protocols. the infectious hazards of gene therapy are theoretical at this time but require meticulous surveillance due to the possible occurrence of in vivo recombination and the subsequent emergence of a transmissible genetically altered pathogen. the greatest concern attends the use of replication-competent viruses, especially vaccinia. to date, no reports have described transmission of a vector virus from a gene therapy recipient to another individual, but surveillance is ongoing. recommendations for monitoring infection control issues throughout the course of gene therapy trials have been published. [ ] [ ] [ ] i.f. . infections transmitted through blood, organs, and other tissues. the potential hazard of transmitting infectious pathogens through biologic products is a small but ever-present risk, despite donor screening. reported infections transmitted by transfusion or transplantation include west nile virus infection, cytomegalovirus infection, cjd, hepatitis c, infections with clostridium spp and group a streptococcus, malaria, babesiosis, chagas disease, lymphocytic choriomeningitis, and rabies. , therefore, it is important to consider receipt of biologic products when evaluating patients for potential sources of infection. i.f. . xenotransplantation. transplantation of nonhuman cells, tissues, and organs into humans potentially exposes patients to zoonotic pathogens. transmission of known zoonotic infections (eg, trichinosis from porcine tissue) is of concern. also of concern is the possibility that transplantation of nonhuman cells, tissues, or organs may transmit previously unknown zoonotic infections (xenozoonoses) to immunosuppressed human recipients. potential infections that potentially could accompany transplantation of porcine organs have been described previously. guidelines from the us public health service address many infectious diseases and infection control issues that surround the developing field of xenotransplantation; policies and procedures that explain how standard precautions and transmission-based precautions are applied, including systems used to identify and communicate information on patients with potentially transmissible infectious agents, are essential to ensure the success of these measures. these policies and procedures may vary according to the characteristics of the organization. a key administrative measure is the provision of fiscal and human resources for maintaining infection control and occupational health programs that are responsive to emerging needs. specific components include bedside nurse and infection prevention and control professional (icp) staffing levels, inclusion of icps in facility construction and design decisions, clinical microbiology laboratory support, , adequate supplies and equipment including facility ventilation systems, adherence monitoring, assessment and correction of system failures that contribute to transmission, , and provision of feedback to hcws and senior administrators. , , , the positive influence of institutional leadership has been demonstrated repeatedly in studies of hcws' adherence to recommended hand hygiene practices. , , , , , [ ] [ ] [ ] [ ] [ ] [ ] health care administrators' involvement in the infection control processes can improve their awareness of the rationale and resource requirements for following recommended infection control practices. several administrative factors may affect the transmission of infectious agents in health care settings, including the institutional culture, individual hcw behavior, and the work environment. each of these areas is suitable for performance improvement monitoring and incorporation into the organization's patient safety goals. , , , ii.a. .a. scope of work and staffing needs for infection control professionals. the effectiveness of infection surveillance and control programs in preventing nosocomial infections in ust hospitals was assessed by the cdc through the study on the efficacy of nosocomial infection control (senic project) conducted between and . in a representative sample of us general hospitals, those with a trained infection control physician or microbiologist involved in an infection control program and at least infection control nurse per beds were associated with a % lower rate of the infections studied (cvc-associated bloodstream infections, ventilator-associated pneumonias, catheter-related urinary tract infections, and surgical site infections). since the publication of that landmark study, responsibilities of icps have expanded commensurate with the growing complexity of the health care system, the patient populations served, and the increasing numbers of medical procedures and devices used in all types of health care settings. the scope of work of icps was first assessed in - by the certification board of infection control, and has been reassessed every years since that time. , [ ] [ ] [ ] the findings of these analyses have been used to develop and update the infection control certification examination, which was first offered in . with each new survey, it becomes increasingly apparent that the role of the icp is growing in complexity and scope beyond traditional infection control activities in acute care hospitals. activities currently assigned to icps in response to emerging challenges include ( ) surveillance and infection prevention at facilities other than acute care hospitals (eg, ambulatory clinics, day surgery centers, ltcfs, rehabilitation centers, home care); ( ) oversight of employee health services related to infection prevention (eg, assessment of risk and administration of recommended treatment after exposure to infectious agents, tuberculosis screening, influenza vaccination, respiratory protection fit testing, and administration of other vaccines as indicated, such as smallpox vaccine in ); ( ) preparedness planning for annual influenza outbreaks, pandemic influenza, sars, and bioweapons attacks; ( ) adherence monitoring for selected infection control practices; ( ) oversight of risk assessment and implementation of prevention measures associated with construction and renovation; ( ) prevention of transmission of mdros; ( ) evaluation of new medical products that could be associated with increased infection risk (eg, intravenous infusion materials); ( ) communication with the public, facility staff, and state and local health departments concerning infection control-related issues; and ( ) participation in local and multicenter research projects. , , , , , none of the certification board of infection control job analyses addressed specific staffing requirements for the identified tasks, although the surveys did include information about hours worked; the survey included the number of icps assigned to the responding facilities. there is agreement in the literature that a ratio of icp per acute care beds is no longer adequate to meet current infection control needs; a delphi project that assessed staffing needs of infection control programs in the st century concluded that a ratio of . to . icp per occupied acute care beds is an appropriate staffing level. a survey of participants in the nnis system found an average daily patient census of per icp. results of other studies have been similar: per beds for large acute care hospitals, per to beds in ltcfs, and . per in small rural hospitals. , the foregoing demonstrates that infection control staffing no longer can be based on patient census alone, but rather must be determined by the scope of the program, characteristics of the patient population, complexity of the health care system, tools available to assist personnel to perform essential tasks (eg, electronic tracking and laboratory support for surveillance), and unique or urgent needs of the institution and community. furthermore, appropriate training is required to optimize the quality of work performed. , , ii.a. .a.i. infection control nurse liaison. designating a bedside nurse on a patient care unit as an infection control liaison or ''link nurse'' is reported to be an effective adjunct to enhance infection control at the unit level. [ ] [ ] [ ] [ ] [ ] [ ] such individuals receive training in basic infection control and have frequent communication with icps, but maintain their primary role as bedside caregiver on their units. the infection control nurse liaison increases the awareness of infection control at the unit level. he or she is especially effective in implementating new policies or control interventions because of the rapport with individuals on the unit, an understanding of unit-specific challenges, and ability to promote strategies that are most likely to be successful in that unit. this position is an adjunct to, not a replacement for, fully trained icps. furthermore, the infection control liaison nurses should not be counted when considering icp staffing. there is increasing evidence that the level of bedside nurse staffing influences the quality of patient care. , adequate nursing staff makes it more likely that infection control practices, including hand hygiene, standard precautions, and transmission-based precautions, will be given appropriate attention and applied correctly and consistently. a national multicenter study reported strong and consistent inverse relationships between nurse staffing and adverse outcomes in medical patients, of which were hais (urinary tract infections and pneumonia). the association of nursing staff shortages with increased rates of hai has been demonstrated in several outbreaks in hospitals and ltcfs, and with increased transmission of hepatitis c virus in dialysis units. , , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] in most cases, when staffing was improved as part of a comprehensive control intervention, the outbreak ended or the hai rate declined. in studies, , the composition of the nursing staff (''pool'' or ''float'' vs regular staff nurses) influenced the rate of primary bloodstream infections, with an increased infection rate occurring when the proportion of regular nurses decreased and that of pool nurses increased. ii.a. .c. clinical microbiology laboratory support. the critical role of the clinical microbiology laboratory in infection control and health care epidemiology has been well described , , [ ] [ ] [ ] and is supported by the infectious disease society of america's policy statement on the consolidation of clinical microbiology laboratories published in . the clinical microbiology laboratory contributes to preventing transmission of infectious diseases in health care settings by promptly detecting and reporting epidemiologically important organisms, identifying emerging patterns of antimicrobial resistance, and assessing the effectiveness of recommended precautions to limit transmission during outbreaks. outbreaks of infections may be recognized first by laboratorians. health care organizations need to ensure the availability of the recommended scope and quality of laboratory services, a sufficient number of appropriately trained laboratory staff members, and systems to promptly communicate epidemiologically important results to those who will take action (eg, providers of clinical care, infection control staff, health care epidemiologists, and infectious disease consultants). as concerns about emerging pathogens and bioterrorism grow, the role of the clinical microbiology laboratory assumes ever-greater importance. for health care organizations that outsource microbiology laboratory services (eg, ambulatory care, home care, ltcfs, smaller acute care hospitals), it is important to specify by contract the types of services (eg, periodic institution-specific aggregate susceptibility reports) required to support infection control. several key functions of the clinical microbiology laboratory are relevant to this guideline: ii.a. . institutional safety culture and organizational characteristics. safety culture (or safety climate) refers to a work environment in which a shared commitment to safety on the part of management and the workforce is understood and maintained. , , the authors of the institute of medicine's report titled to err is human acknowledged that causes of medical error are multifaceted but emphasized the pivotal role of system failures and the benefits of a safety culture. a safety culture is created through ( ) the actions that management takes to improve patient and worker safety, ( ) worker participation in safety planning, ( ) the availability of appropriate ppe, ( ) the influence of group norms regarding acceptable safety practices, and ( ) the organization's socialization process for new personnel. safety and patient outcomes can be enhanced by improving or creating organizational characteristics within patient care units, as demonstrated by studies of surgical icus. , each of these factors has a direct bearing on adherence to transmission prevention recommendations. measurement of an institution's culture of safety is useful in designing improvements in health care. , several hospitalbased studies have linked measures of safety culture with both employee adherence to safe practices and reduced exposures to blood and body fluids. [ ] [ ] [ ] [ ] [ ] [ ] [ ] one study of hand hygiene practices concluded that improved adherence requires integration of infection control into the organization's safety culture. several hospitals that are part of the veterans administration health care system have taken specific steps toward improving the safety culture, including error-reporting mechanisms, root cause analyses of identified problems, safety incentives, and employee education. [ ] [ ] [ ] ii.a. . adherence of health care workers to recommended guidelines. hcws' adherence to recommended infection control practices decreases the transmission of infectious agents in health care settings. , , [ ] [ ] [ ] [ ] [ ] several observational studies have shown limited adherence to recommended practices by hcws. , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] observed adherence to universal precautions ranged from % to %. , , , , the degree of adherence often depended on the specific practice that was assessed and, for glove use, the circumstance in which the practice was applied. observed rates of appropriate glove use has ranged from a low of % to a high of %. however, % and % adherence with glove use have been reported during arterial blood gas collection and resuscitation, respectively, procedures in which considerable blood contact may occur. , differences in observed adherence have been reported among occupational groups in the same health care facility and between experienced and nonexperienced professionals. in surveys of hcws, self-reported adherence was generally higher than actual adherence found in observational studies. furthermore, where an observational component was included with a self-reported survey, self-perceived adherence was often greater than observed adherence. among nurses and physicians, increasing years of experience is a negative predictor of adherence. , education to improve adherence is the primary intervention that has been studied. whereas positive changes in knowledge and attitude have been demonstrated, , no or only limited accompanying changes in behavior often have been found. , self-reported adherence is higher in groups that received an educational intervention. , in one study, educational interventions that incorporated videotaping and performance feedback were successful in improving adherence during the study period, but the long-term effect of such interventions is not known. the use of videotaping also served to identify system problems (eg, communication and access to ppe) that otherwise may not have been recognized. interest is growing in the use of engineering controls and facility design concepts for improving adherence. whereas the introduction of automated sinks was found to have a negative impact on consistent adherence to handwashing in one study, the use of electronic monitoring and voice prompts to remind hcws to perform hand hygiene and improving accessibility to hand hygiene products increased adherence and contributed to a decrease in hais in another study. more information is needed regarding ways in which technology might improve adherence. improving adherence to infection control practices requires a multifaceted approach that incorporates continuous assessment of both the individual and the work environment. , using several behavioral theories, kretzer and larson concluded that a single intervention (eg, a handwashing campaign or putting up new posters about transmission precautions) likely would be ineffective in improving hcws adherence. improvement requires the organizational leadership to make prevention an institutional priority and integrate infection control practices into the organization's safety culture. a recent review of the literature concluded that variations in organizational factors (eg, safety climate, policies and procedures, education and training) and individual factors (eg, knowledge, perceptions of risk, past experience) were determinants of adherence to infection control guidelines for protection against sars and other respiratory pathogens. surveillance is an essential tool for case finding of single patients or clusters of patients who are infected or colonized with epidemiologically important organisms (eg, susceptible bacteria such as s aureus, s pyogenes [group a streptococcus] or enterobacter-klebsiella spp; mrsa, vre, and other mdros; c difficile; rsv; influenza virus) for which transmission-based precautions may be required. surveillance is defined as the ongoing systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event for use in public health action to reduce morbidity and mortality and to improve health. the work of ignaz semmelweis delineating the role of person-toperson transmission in puerperal sepsis is the earliest example of the use of surveillance data to reduce transmission of infectious agents. surveillance of both process measures and the infection rates to which they are linked is important in evaluating the effectiveness of infection prevention efforts and identifying indications for change. , [ ] [ ] [ ] [ ] the study on the efficacy of nosocomial infection control (senic) found that different combinations of infection control practices resulted in reduced rates of nosocomial surgical site infections, pneumonia, urinary tract infections, and bacteremia in acute care hospitals; however, surveillance was the only component essential for reducing all types of hais. although a similar study has not been conducted in other health care settings, a role for surveillance and the need for novel strategies in ltcfs , , , and in home care [ ] [ ] [ ] [ ] have been described. the essential elements of a surveillance system are ( ) standardized definitions, ( ) identification of patient populations at risk for infection, ( ) statistical analysis (eg, risk adjustment, calculation of rates using appropriate denominators, trend analysis using such methods as statistical process control charts), and ( ) feedback of results to the primary caregivers. [ ] [ ] [ ] [ ] [ ] [ ] data gathered through surveillance of high-risk populations, device use, procedures, and facility locations (eg, icus) are useful in detecting transmission trends. [ ] [ ] [ ] identification of clusters of infections should be followed by a systematic epidemiologic investigation to determine commonalities in persons, places, and time and to guide implementation of interventions and evaluation of the effectiveness of those interventions. targeted surveillance based on the highest-risk areas or patients has been preferred over facility-wide surveillance for the most effective use of resources. , however, for certain epidemiologically important organisms, surveillance may need to be facility-wide. surveillance methods will continue to evolve as health care delivery systems change , and user-friendly electronic tools for electronic tracking and trend analysis become more widely available. , , individuals with experience in health care epidemiology and infection control should be involved in selecting software packages for data aggregation and analysis, to ensure that the need for efficient and accurate hai surveillance will be met. effective surveillance is increasingly important as legislation requiring public reporting of hai rates is passed and states work to develop effective systems to support such legislation. the education and training of hcws is a prerequisite for ensuring that policies and procedures for standard and transmission-based precautions are understood and practiced. understanding the scientific rationale for the precautions will allow hcws to apply procedures correctly, as well as to safely modify precautions based on changing requirements, resources, or health care settings. , , - one study found that the likelihood of hcws developing sars was strongly associated with less than hours of infection control training and poor understanding of infection control procedures. education regarding the important role of vaccines (eg, influenza, measles, varicella, pertussis, pneumococcal) in protecting hcws, their patients, and family members can help improve vaccination rates. [ ] [ ] [ ] [ ] education on the principles and practices for preventing transmission of infectious agents should begin during training in the health professions and be provided to anyone who has an opportunity for contact with patients or medical equipment (eg, nursing and medical staff; therapists and technicians, including respiratory, physical, occupational, radiology, and cardiology personnel; phlebotomists; housekeeping and maintenance staff; and students). in health care facilities, education and training on standard and transmission-based precautions are typically provided at the time of orientation and should be repeated as necessary to maintain competency; updated education and training are necessary when policies and procedures are revised or when a special circumstance occurs, such as an outbreak that requires modification of current practice or adoption of new recommendations. education and training materials and methods appropriate to the hcw's level of responsibility, individual learning habits, and language needs can improve the learning experience. , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] education programs for hcws have been associated with sustained improvement in adherence to best practices and a related decrease in device-associated hais in teaching and nonteaching settings , and in medical and surgical icus (coopersmith, # ) . several studies have shown that in addition to targeted education to improve specific practices, periodic assessment and feedback of the hcw's knowledge and adherence to recommended practices are necessary to achieve the desired changes and identify continuing education needs. , [ ] [ ] [ ] [ ] [ ] the effectiveness of this approach for isolation practices has been demonstrated in the control of rsv. , patients, family members, and visitors can be partners in preventing transmission of infections in health care settings. , , - information on standard precautions, especially hand hygiene, respiratory hygiene/cough etiquette, vaccination (especially against influenza), and other routine infection prevention strategies, may be incorporated into patient information materials provided on admission to the health care facility. additional information on transmission-based precautions is best provided when these precautions are initiated. fact sheets, pamphlets, and other printed material may include information on the rationale for the additional precautions, risks to household members, room assignment for transmission-based precautions purposes, explanation of the use of ppe by hcws, and directions for use of such equipment by family members and visitors. such information may be particularly helpful in the home environment, where household members often have the primary responsibility for adherence to recommended infection control practices. hcws must be available and prepared to explain this material and answer questions as needed. hand hygiene has been frequently cited as the single most important practice to reduce the transmission of infectious agents in health care settings , , and is an essential element of standard precautions. the term ''hand hygiene'' includes both handwashing with either plain or antiseptic-containing soap and water and the use of alcohol-based products (gels, rinses, foams) that do not require water. in the absence of visible soiling of hands, approved alcohol-based products for hand disinfection are preferred over antimicrobial or plain soap and water because of their superior microbiocidal activity, reduced drying of the skin, and convenience. have been associated with a sustained decrease in the incidence of mrsa and vre infections primarily in icus. , , [ ] [ ] [ ] [ ] the scientific rationale, indications, methods, and products for hand hygiene have been summarized in previous publications. , the effectiveness of hand hygiene can be reduced by the type and length of fingernails. , , individuals wearing artificial nails have been shown to harbor more pathogenic organisms, especially gram-negative bacilli and yeasts, on the nails and in the subungual area compared with individuals with native nails. , in , the cdc/hicpac recommended (category ia) that artificial fingernails and extenders not be worn by hcws who have contact with high-risk patients (eg, those in icus and operating rooms), due to the association with outbreaks of gram-negative bacillus and candidal infections as confirmed by molecular typing of isolates. , , , [ ] [ ] [ ] [ ] the need to restrict the wearing of artificial fingernails by all hcws who provide direct patient care and those who have contact with other high-risk groups (eg, oncology and cystic fibrosis patients) has not been studied but has been recommended by some experts. currently, such decisions are at the discretion of an individual facility's infection control program. there is less evidence indicating that jewelry affects the quality of hand hygiene. although hand contamination with potential pathogens is increased with ring-wearing, , no studies have related this practice to hcw-to-patient transmission of pathogens. ppe refers to various barriers and respirators used alone or in combination to protect mucous membranes, airways, skin, and clothing from contact with infectious agents. the choice of ppe is based on the nature of the patient interaction and/or the likely mode(s) of transmission. specific guidance on the use of ppe is provided in part iii of this guideline. a suggested procedure for donning and removing ppe aimed at preventing skin or clothing contamination is presented in figure . designated containers for used disposable or reusable ppe should be placed in a location convenient to the site of removal, to facilitate disposal and containment of contaminated materials. hand hygiene is always the final step after removing and disposing of ppe. the following sections highlight the primary uses of and criteria for selecting this equipment. ii.e. . gloves. gloves are used to prevent contamination of hcw hands when ( ) anticipating direct contact with blood or body fluids, mucous membranes, nonintact skin and other potentially infectious material; ( ) having direct contact with patients who are colonized or infected with pathogens transmitted by the contact route (eg, vre, mrsa, rsv , , ); or ( ) handling or touching visibly or potentially contaminated patient care equipment and environmental surfaces. , , gloves can protect both patients and hcws from exposure to infectious material that may be carried on hands. the extent to which gloves will protect hcws from transmission of bloodborne pathogens (eg, hiv, hbv, hcv) after a needlestick or other puncture that penetrates the glove barrier has not yet been determined. although gloves may reduce the volume of blood on the external surface of a sharp by % to %, the residual blood in the lumen of a hollow-bore needle would not be affected; therefore, the effect on transmission risk is unknown. gloves manufactured for health care purposes are subject to fda evaluation and clearance. nonsterile disposable medical gloves made of various materials (eg, latex, vinyl, nitrile) are available for routine patient care. the selection of glove type for nonsurgical use is based on various factors, including the task to be performed, anticipated contact with chemicals and chemotherapeutic agents, latex sensitivity, sizing, and facility policies for creating a latex-free environment. , [ ] [ ] [ ] for contact with blood and body fluids during nonsurgical patient care, a single pair of gloves generally provides adequate barrier protection. however, there is considerable variability among gloves; both the quality of the manufacturing process and type of material influence their barrier effectiveness. whereas there is little difference in the barrier properties of unused intact gloves, studies have shown repeatedly that vinyl gloves have higher failure rates than latex or nitrile gloves when tested under simulated and actual clinical conditions. , [ ] [ ] [ ] [ ] for this reason, either latex or nitrile gloves are preferable for clinical procedures that require manual dexterity or will involve more than brief patient contact. a facility may need to stock gloves in several sizes. heavier, reusable utility gloves are indicated for non-patient care activities, such as handling or cleaning contaminated equipment or surfaces. , , during patient care, transmission of infectious organisms can be reduced by adhering to the principles of working from ''clean'' to ''dirty'' and confining or limiting contamination to those surfaces directly needed for patient care. it may be necessary to change gloves during the care of a single patient to prevent cross-contamination of body sites. , it also may be necessary to change gloves if the patient interaction also involves touching portable computer keyboards or other mobile equipment transported from room to room. discarding gloves between patients is necessary to prevent transmission of infectious material. gloves must not be washed for subsequent reuse, because microorganisms cannot be removed reliably from glove surfaces, and continued glove integrity cannot be ensured. furthermore, glove reuse has been associated with transmission of mrsa and gram-negative bacilli. [ ] [ ] [ ] when gloves are worn in combination with other ppe, they are put on last. gloves that fit snugly around the wrist are preferred for use with an isolation gown, because they will cover the gown cuff and provide a more reliable continuous barrier for the arms, wrists, and hands. proper glove removal will prevent hand contamination (fig ) . hand hygiene after glove removal further ensures that the hands will not carry potentially infectious material that might have penetrated through unrecognized tears or that could have contaminated the hands during glove removal. , , ii.e. . isolation gowns. isolation gowns are used as specified by standard and transmission-based precautions to protect the hcw's arms and exposed body areas and prevent contamination of clothing with blood, body fluids, and other potentially infectious material. , , , [ ] [ ] [ ] the need for and the type of isolation gown selected is based on the nature of the patient interaction, including the anticipated degree of contact with infectious material and potential for blood and body fluid penetration of the barrier. the wearing of isolation gowns and other protective apparel is mandated by the occupational safety and health administration's (osha) bloodborne pathogens standard. clinical and laboratory coats or jackets worn over personal clothing for comfort and/or purposes of identity are not considered ppe. when applying standard precautions, an isolation gown is worn only if contact with blood or body fluid is anticipated. however, when contact precautions are used (ie, to prevent transmission of an infectious agent that is not interrupted by standard precautions alone and is associated with environmental contamination), donning of both gown and gloves on room entry is indicated, to prevent unintentional contact with contaminated environmental surfaces. , , , the routine donning of isolation gowns on entry into an icu or other high-risk area does not prevent or influence potential colonization or infection of patients in those areas, however. , [ ] [ ] [ ] [ ] isolation gowns are always worn in combination with gloves, and with other ppe when indicated. gowns are usually the first piece of ppe to be donned. full coverage of the arms and body front, from neck to the mid-thigh or below, will ensure protection of clothing and exposed upper body areas. several gown sizes should be available in a health care facility to ensure appropriate coverage for staff members. isolation gowns should be removed before leaving the patient care area to prevent possible contamination of the environment outside the patient's room. isolation gowns should be removed in a manner that prevents contamination of clothing or skin (fig ) ; the outer, ''contaminated'' side of the gown is turned inward and rolled into a bundle, and then discarded into a designated container for waste or linen to contain contamination. ii.e. . face protection: masks, goggles, and face shields. ii.e. .a. masks. masks are used for primary purposes in health care settings: ( ) placed on hcws to protect them from contact with infectious material from patients (eg, respiratory secretions and sprays of blood or body fluids), consistent with standard precautions and droplet precautions; ( ) placed on hcws engaged in procedures requiring sterile technique, to protect patients from exposure to infectious agents carried in the hcw's mouth or nose; and ( ) placed on coughing patients to limit potential dissemination of infectious respiratory secretions from the patient to others (ie, respiratory hygiene/cough etiquette). masks may be used in combination with goggles to protect the mouth, nose, and eyes, or, alternatively, a face shield may be used instead of a mask and goggles to provide more complete protection for the face, as discussed below. masks should not be confused with particulate respirators used to prevent inhalation of small particles that may contain infectious agents transmitted through the airborne route, as described below. the mucous membranes of the mouth, nose, and eyes are susceptible portals of entry for infectious agents; other skin surfaces also may be portals if skin integrity is compromised (by, eg, acne, dermatitis). , [ ] [ ] [ ] [ ] therefore, use of ppe to protect these body sites is an important component of standard precautions. the protective effect of masks for exposed hcws has been demonstrated previously. , , , procedures that generate splashes or sprays of blood, body fluids, secretions, or excretions (eg, endotracheal suctioning, bronchoscopy, invasive vascular procedures) require either a face shield (disposable or reusable) or a mask and goggles. [ ] [ ] [ ] [ ] , , , , the wearing of masks, eye protection, and face shields in specified circumstances when blood or body fluid exposure is likely is mandated by osha's bloodborne pathogens standard. appropriate ppe should be selected based on the anticipated level of exposure. two mask types are available for use in health care settings: surgical masks that are cleared by the fda and required to have fluid-resistant properties, and procedure or isolation masks. ,# to date, no studies comparing mask types to determine whether one mask type provides better protection than another have been published. because procedure/isolation masks are not regulated by the fda, they may be more variable in terms of quality and performance than surgical masks. masks come in various shapes (eg, molded and nonmolded), sizes, filtration efficiency, and method of attachment (eg, ties, elastic, ear loops). health care facilities may find that different types of masks are needed to meet individual hcw needs. ii.e. .b. goggles and face shields. guidance on eye protection for infection control has been published. the eye protection chosen for specific work situations (eg, goggles or face shield) depends on the circumstances of exposure, other ppe used, and personal vision needs. personal eyeglasses and contact lenses are not considered adequate eye protection (see http://www.cdc.gov/ niosh/topics/eye/eye-infectious.html). niosh guidelines specify that eye protection must be comfortable, allow for sufficient peripheral vision, and adjustable to ensure a secure fit. a health care facility may need to provide several different types, styles, and sizes of eye protection equipment. indirectly vented goggles with a manufacturer's antifog coating may provide the most reliable practical eye protection from splashes, sprays, and respiratory droplets from multiple angles. newer styles of goggles may provide better indirect airflow properties to reduce fogging, as well as better peripheral vision and more size options for fitting goggles to different workers. many styles of goggles fit adequately over prescription glasses with minimal gaps. although effective as eye protection, goggles do not provide splash or spray protection to other parts of the face. the role of goggles in addition to a mask in preventing exposure to infectious agents transmitted through respiratory droplets has been studied only for rsv. reports published in the mid- s demonstrated that eye protection reduced occupational transmission of rsv. , whether this was due to the prevention hand-eye contact or the prevention of respiratory droplet-eye contact has not been determined. however, subsequent studies demonstrated that rsv transmission is effectively prevented by adherence to standard precautions plus contact precautions and that routine use of goggles is not necessary for this virus. , , , , it is important to remind hcws that even if droplet precautions are not recommended for a specific respiratory tract pathogen, protection for the eyes, nose, and mouth using a mask and goggles or a face shield alone is necessary when a splash or spray of any respiratory secretions or other body fluids is likely to occur, as defined in standard precautions. disposable or nondisposable face shields may be used as an alternative to goggles. compared with goggles, a face shield can provide protection to other facial areas besides the eyes. face shields extending from the chin to crown provide better face and eye protection from splashes and sprays; face shields that wrap around the sides may reduce splashes around the edge of the shield. removal of a face shield, goggles, and mask can be performed safely after gloves have been removed and hand hygiene performed. the ties, earpieces, and/or headband used to secure the equipment to the head are considered ''clean'' and thus safe to touch with bare hands. the front of a mask, goggles, and face shield are considered contaminated (fig ) . ii.e. . respiratory protection. the subject of respiratory protection as it applies to preventing transmission of airborne infectious agents, including the need for and frequency of fit testing is under scientific review and was the subject of a cdc workshop. respiratory protection currently requires the use of a respirator with n or higher-level filtration to prevent inhalation of infectious particles. information about respirators and respiratory protection programs is summarized in the guideline for preventing transmission of mycobacterium tuberculosis in health care settings. respiratory protection is broadly regulated by osha under the general industry standard for respiratory protection ( cfr . ), which requires that us employers in all employment settings implement a program to protect employees from inhalation of toxic materials. osha program components include medical clearance to wear a respirator; provision and use of appropriate respirators, including fit-tested niosh-certified n and higher-level particulate filtering respirators; education on respirator use, and periodic reevaluation of the respiratory protection program. when selecting particulate respirators, models with inherently good fit characteristics (ie, those expected to provide protection factors of $ % to % of wearers) are preferred and theoretically could preclude the need for fit testing. , issues pertaining to respiratory protection remain the subject of ongoing debate. information on various types of respirators is available at http://www.cdc.gov/niosh/ npptl/respirators/respsars.html and in several previously published studies. , , a user-seal check (formerly called a ''fit check'') should be performed by the wearer of a respirator each time that the respirator is donned, to minimize air leakage around the face piece. the optimal frequency of fit testing has not been determined; retesting may be indicated if there is a change in wearer's facial features, onset of a medical condition that would affect respiratory function in the wearer, or a change in the model or size of the respirator that was initially assigned. respiratory protection was first recommended for protection of us hcws from exposure to m tuberculosis in . that recommendation has been maintained in successive revisions of the guidelines for prevention of transmission of tuberculosis in hospitals and other health care settings. , the incremental benefit from respirator use, in addition to administrative and engineering controls (ie, aiirs, early recognition of patients likely to have tuberculosis and prompt placement in an aiir, and maintenance of a patient with suspected tuberculosis in an aiir until no longer infectious), for preventing transmission of airborne infectious agents (eg, m tuberculosis) remains undetermined. although some studies have demonstrated effective prevention of m tuberculosis transmission in hospitals in which surgical masks instead of respirators were used in conjunction with other administrative and engineering controls. , , the cdc currently recommends n or higher-level respirators for personnel exposed to patients with suspected or confirmed tuberculosis. currently, this recommendation also holds for other diseases that could be transmitted through the airborne route, including sars and smallpox, , , until inhalational transmission is better defined or health care-specific ppe more suitable for preventing infection is developed. wearing of respirators is also currently recommended during the performance of aerosol-generating procedures (eg, intubation, bronchoscopy, suctioning) in patients with sars-cov infection, avian influenza, and pandemic influenza (see appendix a). although airborne precautions are recommended for preventing airborne transmission of measles and varicella-zoster viruses, no data are available on which to base a recommendation for respiratory protection to protect susceptible personnel against these infections. transmission of varicella-zoster virus has been prevented among pediatric patients using negativepressure isolation alone. whether respiratory protection (ie, wearing a particulate respirator) will enhance protection from these viruses has not yet been studied. because most hcws have natural or acquired immunity to these viruses, only immune personnel generally care for patients with these infections. [ ] [ ] [ ] [ ] although there is no evidence suggesting that masks are not adequate to protect hcws in these settings, for purposes of consistency and simplicity, or because of difficulties in ascertaining immunity, some facilities may require the use of respirators for entry into all aiirs, regardless of the specific infectious agent present. procedures for safe removal of respirators are provided in figure . in some health care settings, particulate respirators used to provide care for patients with m tuberculosis are reused by the same hcw. this is an acceptable practice providing that the respirator is not damaged or soiled, the fit is not compromised by a change in shape, and the respirator has not been contaminated with blood or body fluids. no data are available on which to base a recommendation regarding the length of time that a respirator may be safely reused. sharps-related injuries. injuries due to needles and other sharps have been associated with transmission of hbv, hcv, and hiv to hcws. , the prevention of sharps injuries has always been an essential element of universal precautions and is now an aspect of standard precautions. , these include measures to handle needles and other sharp devices in a manner that will prevent injury to the user and to others who may encounter the device during or after a procedure. these measures apply to routine patient care and do not address the prevention of sharps injuries and other blood exposures during surgical and other invasive procedures addressed elsewhere. [ ] [ ] [ ] [ ] [ ] since , when osha first issued its bloodborne pathogens standard to protect hcws from blood exposure, the focus of regulatory and legislative activity has been on implementing a hierarchy of control measures. this has included focusing attention on removing sharps hazards through the development and use of engineering controls. the federal needlestick safety and prevention act, signed into law in november , authorized osha's revision of its bloodborne pathogens standard to more explicitly require the use of safety-engineered sharps devices. the cdc has provided guidance on sharps injury prevention, , including guidelines for the design, implementation and evaluation of a comprehensive sharps injury prevention program. ii.f. . prevention of mucous membrane contact. exposure of mucous membranes of the eyes, nose, and mouth to blood and body fluids has been associated with the transmission of bloodborne viruses and other infectious agents to hcws. , , , the prevention of mucous membrane exposures has always been an element of universal precautions and is now an element of standard precautions for routine patient care , and is subject to osha bloodborne pathogen regulations. safe work practices, in addition to wearing ppe, are designed to protect mucous membranes and nonintact skin from contact with potentially infectious material. these include keeping contaminated gloved and ungloved hands from touching the mouth, nose, eyes, or face and positioning patients to direct sprays and splatter away from the caregiver's face. careful placement of ppe before patient contact will help avoid the need to make adjustments to ppe and prevent possible face or mucous membrane contamination during use. in areas where the need for resuscitation is unpredictable, mouthpieces, pocket resuscitation masks with -way valves, and other ventilation devices provide an alternative to mouth-to-mouth resuscitation, preventing exposure of the caregiver's nose and mouth to oral and respiratory fluids during the procedure. ii.f. .a. precautions during aerosol-generating procedures. the performance of procedures that can generate small-particle aerosols (aerosol-generating procedures), such as bronchoscopy, endotracheal intubation, and open suctioning of the respiratory tract, have been associated with transmission of infectious agents to hcws, including m tuberculosis, sars-cov, , , and n meningitidis. protection of the eyes, nose, and mouth, in addition to gown and gloves, is recommended during performance of these procedures in accordance with standard precautions. the use of a particulate respirator is recommended during aerosol-generating procedures when the aerosol is likely to contain m tuberculosis, sars-cov, or avian or pandemic influenza viruses. ii.g. . hospitals and long-term care facilities. options for patient placement include single-patient rooms, -patient rooms, and multibed wards. of these, single-patient rooms are preferred when transmission of an infectious agent is of concern. although some studies have failed to demonstrate the efficacy of single-patient rooms in preventing hais, other published studies, including one commissioned by the aia and the facility guidelines institute, have documented a beneficial relationship between private rooms and reduced infectious and noninfectious adverse patient outcomes. , the aia notes that private rooms are the trend in hospital planning and design. however, most hospitals and ltcfs have multibed rooms and must consider many competing priorities when determining the appropriate room placement for patients (eg, reason for admission; patient characteristics, such as age, gender, and mental status; staffing needs; family requests; psychosocial factors; reimbursement concerns). in the absence of obvious infectious diseases that require specified airborne infection isolation rooms (eg, tuberculosis, sars, chickenpox), the risk of transmission of infectious agents is not always considered when making placement decisions. when only a limited number of single-patient rooms is available, it is prudent to prioritize room assignments for those patients with conditions that facilitate transmission of infectious material to other patients (eg, draining wounds, stool incontinence, uncontained secretions) and those at increased risk of acquisition and adverse outcomes resulting from hais (due to, eg, immunosuppression, open wounds, indwelling catheters, anticipated prolonged length of stay, total dependence on hcws for activities of daily living). , , , , , single-patient rooms are always indicated for patients placed on airborne precautions in a pe and are preferred for patients requiring contact or droplet precautions. , , , , , during a suspected or proven outbreak caused by a pathogen whose reservoir is the gastrointestinal tract, the use of single-patient rooms with private bathrooms limits opportunities for transmission, especially when the colonized or infected patient has poor personal hygiene habits or fecal incontinence, or cannot be expected to assist in maintaining procedures that prevent transmission of microorganisms (eg, infants, children, and patients with altered mental status or developmental delay). in the absence of continued transmission, it is not necessary to provide a private bathroom for patients colonized or infected with enteric pathogens as long as personal hygiene practices and standard precautions (especially hand hygiene and appropriate environmental cleaning) are maintained. assignment of a dedicated commode to a patient, and cleaning and disinfecting fixtures and equipment that may have fecal contamination (eg, bathrooms, commodes, scales used for weighing diapers) and the adjacent surfaces with appropriate agents may be especially important when a single-patient room cannot be assigned, because environmental contamination with intestinal tract pathogens is likely from both continent and incontinent patients. , the results of several studies that investigated the benefit of a single-patient room in preventing transmission of c difficile were inconclusive. , [ ] [ ] [ ] some studies have shown that being in the same room with a colonized or infected patient is not necessarily a risk factor for transmission; , - however, for children, the risk of health care-associated diarrhea is increased with the increased number of patients per room. these findings demonstrate that patient factors are important determinants of infection transmission risks. the need for a single-patient room and/or private bathroom for any patient is best determined on a case-by-case basis. cohorting is the practice of grouping together patients who are colonized or infected with the same organism to confine their care to a single area and prevent contact with other patients. cohorts are created based on clinical diagnosis, microbiologic confirmation (when available), epidemiology, and mode of transmission of the infectious agent. avoiding placing severely immunosuppressed patients in rooms with other patients is generally preferred. cohorting has been extensively used for managing outbreaks of mdros, including mrsa, rotavirus, and sars. modeling studies provide additional support for cohorting patients to control outbreaks; - however, cohorting often is implemented only after routine infection control measures have failed to control an outbreak. assigning or cohorting hcws to care only for patients infected or colonized with a single target pathogen limits further transmission of the target pathogen to uninfected patients, , but is difficult to achieve in the face of current staffing shortages in hospitals and residential health care sites. [ ] [ ] [ ] however, cohorting of hcws may be beneficial when transmission continues after implementing routine infection control measures and creating patient cohorts. during periods when rsv, human metapneumovirus, parainfluenza, influenza, other respiratory viruses, and rotavirus are circulating in the community, cohorting based on the presenting clinical syndrome is often a priority in facilities that care for infants and young children. for example, during the respiratory virus season, infants may be cohorted based solely on the clinical diagnosis of bronchiolitis, due to the logistical difficulties and costs associated with requiring microbiologic confirmation before room placement and the predominance of rsv during most of the season. however, when available, single-patient rooms are always preferred, because a common clinical presentation (eg, bronchiolitis), can be caused by more than infectious agent. , , furthermore, the inability of infants and children to contain body fluids, and the close physical contact associated with their care, increases the risk of infection transmission for patients and personnel in this setting. , ii.g. . ambulatory care settings. patients actively infected with or incubating transmissible infectious diseases are frequently seen in ambulatory settings (eg, outpatient clinics, physicians' offices, emergency departments) and potentially expose hcws and other patients, family members, and visitors. , , , , , in response to the global outbreak of sars in and in preparation for pandemic influenza, hcws working in outpatient settings are urged to implement source containment measures (eg, asking coughing patients to wear a surgical mask or cover coughing with tissues) to prevent transmission of respiratory infections, beginning at the initial patient encounter, , , as described in section iii.a. .a. signs can be posted at the facility's entrance or at the reception or registration desk requesting that the patient or individuals accompanying the patient promptly inform the receptionist of any symptoms of respiratory infection (eg, cough, flulike illness, increased production of respiratory secretions). the presence of diarrhea, skin rash, or known or suspected exposure to a transmissible disease (eg, measles, pertussis, chickenpox, tuberculosis) also could be added. prompt placement of a potentially infectious patient in an examination room limits the number of exposed individuals in the common waiting area. in waiting areas, maintaining a distance between symptomatic and nonsymptomatic patients (eg, . feet), in addition to source control measures, may limit exposures. however, infections transmitted through the airborne route (eg, m tuberculosis, measles, chickenpox) require additional precautions. , , patients suspected of having such an infection can wear a surgical mask for source containment, if tolerated, and should be placed in an examination room (preferably an aiir) as soon as possible. if this is not possible, then having the patient wear a mask and segregating the patient from other patients in the waiting area will reduce the risk of exposing others. because the person(s) accompanying the patient also may be infectious, application of the same infection control precautions may be extended to these persons if they are symptomatic. , , family members accompanying children admitted with suspected m tuberculosis have been found to have unsuspected pulmonary tuberculosis with cavitary lesions, even when asymptomatic. , patients with underlying conditions that increase their susceptibility to infection (eg, immunocompromised status , or cystic fibrosis ) require special efforts to protect them from exposure to infected patients in common waiting areas. informing the receptionist of their infection risk on arrival allows appropriate steps to further protect these patients from infection. in some cystic fibrosis clinics, to avoid exposure to other patients who could be colonized with b cepacia, patients have been given beepers on registration so that they may leave the area and receive notification to return when an examination room becomes available. ii.g. . home care. in home care, patient placement concerns focus on protecting others in the home from exposure to an infectious household member. for individuals who are especially vulnerable to adverse outcomes associated with certain infections, it may be beneficial to either remove them from the home or segregate them within the home. persons who are not part of the household may need to be prohibited from visiting during the period of infectivity. for example, in a situation where a patient with pulmonary tuberculosis is contagious and being cared for at home, very young children (age under years) and immunocompromised persons who have not yet been infected should be removed or excluded from the household. during the sars outbreak of , segregation of infected persons during the communicable phase of the illness was found to be beneficial in preventing household transmission. , several principles guide the transport of patients requiring transmission-based precautions. in the inpatient and residential settings, these include the following: . limiting transport of such patients to essential purposes, such as diagnostic and therapeutic procedures that cannot be performed in the patient's room. . when transport is necessary, applying appropriate barriers on the patient (eg, mask, gown, wrapping in sheets or use of impervious dressings to cover the affected areas) when infectious skin lesions or drainage are present, consistent with the route and risk of transmission. . notifying hcws in the receiving area of the patient's impending arrival and of the necessary precautions to prevent transmission. . for patients being transported outside the facility, informing the receiving facility and the medi-van or emergency vehicle personnel in advance about the type of transmission-based precautions being used. for tuberculosis, additional precautions may be needed in a small shared air space, such as in an ambulance. cleaning and disinfecting noncritical surfaces in patient care areas is an aspect of standard precautions. in general, these procedures do not need to be changed for patients on transmission-based precautions. the cleaning and disinfection of all patient care areas is important for frequently touched surfaces, especially those closest to the patient, which are most likely to be contaminated (eg, bedrails, bedside tables, commodes, doorknobs, sinks, surfaces and equipment in close proximity to the patient). , , , the frequency or intensity of cleaning may need to be changed, based on the patient's level of hygiene and the degree of environmental contamination and for certain infectious agents with reservoirs in the intestinal tract. this may be particularly important in ltcfs and pediatric facilities, where patients with stool and urine incontinence are encountered more frequently. in addition, increased frequency of cleaning may be needed in a pe to minimize dust accumulation. special recommendations for cleaning and disinfecting environmental surfaces in dialysis centers have been published previously. in all health care settings, administrative, staffing, and scheduling activities should prioritize the proper cleaning and disinfection of surfaces that could be implicated in transmission. during a suspected or proven outbreak in which an environmental reservoir is suspected, routine cleaning procedures should be reviewed, and the need for additional trained cleaning staff should be assessed. adherence should be monitored and reinforced to promote consistent and correct cleaning. us environmental protection agency-registered disinfectants or detergents/disinfectants that best meet the overall needs of the health care facility for routine cleaning and disinfection should be selected. , in general, use of the existing facility detergent/disinfectant according to the manufacturer's recommendations for amount, dilution, and contact time is sufficient to remove pathogens from surfaces of rooms where colonized or infected individuals were housed. this includes those pathogens that are resistant to multiple classes of antimicrobial agents (eg, c difficile, vre, mrsa, mdr-gnb , , , , , , ). most often, environmental reservoirs of pathogens during outbreaks are related to a failure to follow recommended procedures for cleaning and disinfection, rather than to the specific cleaning and disinfectant agents used. [ ] [ ] [ ] [ ] certain pathogens (eg, rotavirus, noroviruses, c difficile) may be resistant to some routinely used hospital disinfectants. , , [ ] [ ] [ ] [ ] [ ] [ ] the role of specific disinfectants in limiting transmission of rotavirus has been demonstrated experimentally. also, because c difficile may display increased levels of spore production when exposed to non-chlorine-based cleaning agents, and because these spores are more resistant than vegetative cells to commonly used surface disinfectants, some investigators have recommended the use of a : dilution of . % sodium hypochlorite (household bleach) and water for routine environmental disinfection of rooms of patients with c difficile when there is continued transmission. , one study found an association between the use of a hypochlorite solution and decreased rates of c difficile infections. the need to change disinfectants based on the presence of these organisms can be determined in consultation with the infection control committee. , , detailed recommendations for disinfection and sterilization of surfaces and medical equipment that have been in contact with prion-containing tissue or high risk body fluids, and for cleaning of blood and body substance spills, are available in the guidelines for environmental infection control in health care facilities and in the guideline for disinfection and sterilization. medical equipment and instruments/devices must be cleaned and maintained according to the manufacturers' instructions to prevent patient-to-patient transmission of infectious agents. , , , cleaning to remove organic material always must precede highlevel disinfection and sterilization of critical and semicritical instruments and devices, because residual proteinacous material reduces the effectiveness of the disinfection and sterilization processes. , noncritical equipment, such as commodes, intravenous pumps, and ventilators, must be thoroughly cleaned and disinfected before being used on another patient. all such equipment and devices should be handled in a manner that will prevent hcw and environmental contact with potentially infectious material. it is important to include computers and personal digital assistants used in patient care in policies for cleaning and disinfection of noncritical items. the literature on contamination of computers with pathogens has been summarized, and reports have linked computer contamination to colonization and infections in patients. , although keyboard covers and washable keyboards that can be easily disinfected are available, the infection control benefit of these items and their optimal management have not yet been determined. in all health care settings, providing patients who are on transmission-based precautions with dedicated noncritical medical equipment (eg, stethoscope, blood pressure cuff, electronic thermometer) has proven beneficial for preventing transmission. , , , , when this is not possible, disinfection of this equipment after each use is recommended. other previously published guidelines should be consulted for detailed guidance in developing specific protocols for cleaning and reprocessing medical equipment and patient care items in both routine and special circumstances. , , , , , , in home care, it is preferable to remove visible blood or body fluids from durable medical equipment before it leaves the home. equipment can be cleaned onsite using a detergent/disinfectant and, when possible, should be placed in a plastic bag for transport to the reprocessing location. , although soiled textiles, including bedding, towels, and patient or resident clothing, may be contaminated with pathogenic microorganisms, the risk of disease transmission is negligible if these textiles are handled, transported, and laundered in a safe manner. , , key principles for handling soiled laundry are ( ) avoiding shaking the items or handling them in any way that may aerosolize infectious agents, ( ) avoiding contact of one's body and personal clothing with the soiled items being handled, and ( ) containing soiled items in a laundry bag or designated bin. if a laundry chute is used, it must be maintained to minimize dispersion of aerosols from contaminated items. methods of handling, transporting, and laundering soiled textiles are determined by organizational policy and any applicable regulations; guidance is provided in the guidelines for environmental infection control in health care facilities. rather than rigid rules and regulations, hygienic and common sense storage and processing of clean textiles is recommended. , when laundering is done outside of a health care facility, the clean items must be packaged or completely covered and placed in an enclosed space during transport to prevent contamination with outside air or construction dust that could contain infectious fungal spores that pose a risk for immunocompromised patients. institutions are required to launder garments used as ppe and uniforms visibly soiled with blood or infective material. little data exist on the safety of home laundering of hcw uniforms, but no increase in infection rates was observed in the one published study, and no pathogens were recovered from home-or hospital-laundered scrubs in another study. in the home, textiles and laundry from patients with potentially transmissible infectious pathogens do not require special handling or separate laundering and may be washed with warm water and detergent. , , the management of solid waste emanating from the health care environment is subject to federal and state regulations for medical and nonmedical waste. , no additional precautions are needed for nonmedical solid waste removed from rooms of patients on transmission-based precautions. solid waste may be contained in a single bag of sufficient strength. the combination of hot water and detergents used in dishwashers is sufficient to decontaminate dishware and eating utensils. therefore, no special precautions are needed for dishware (eg, dishes, glasses, cups) or eating utensils. reusable dishware and utensils may be used for patients requiring transmission-based precautions. in the home and other communal settings, eating utensils and drinking vessels should not be shared, consistent with principles of good personal hygiene and to help prevent transmission of respiratory viruses, herpes simplex virus, and infectious agents that infect the gastrointestinal tract and are transmitted by the fecal/oral route (eg, hepatitis a virus, noroviruses). if adequate resources for cleaning utensils and dishes are not available, then disposable products may be used. important adjunctive measures that are not considered primary components of programs to prevent transmission of infectious agents but nonetheless improve the effectiveness of such programs include ( ) antimicrobial management programs, ( ) postexposure chemoprophylaxis with antiviral or antibacterial agents, ( ) vaccines used both for pre-exposure and postexposure prevention, and ( ) screening and restricting visitors with signs of transmissible infections. detailed discussion of judicious use of antimicrobial agents is beyond the scope of this document; however, this topic has been addressed in a previous cdc guideline (http://www.cdc.gov/ncidod/dhqp/pdf/ar/ mdroguideline .pdf). ii.n. . chemoprophylaxis. antimicrobial agents and topical antiseptics may be used to prevent infection and potential outbreaks of selected agents. infections for which postexposure chemoprophylaxis is recommended under defined conditions include b pertussis, , n meningitides, b anthracis after environmental exposure to aeosolizable material, influenza virus, hiv, and group a streptococcus. orally administered antimicrobials also may be used under defined circumstances for mrsa decolonization of patients or hcws. another form of chemoprophylaxis involves the use of topical antiseptic agents. for example, triple dye is routinely used on the umbilical cords of term newborns to reduce the risk of colonization, skin infections, and omphalitis caused by s aureus, including mrsa, and group a streptococcus. , extension of the use of triple dye to low birth weight infants in a nicu was one component of a program that controlled a long-standing mrsa outbreak. topical antiseptics (eg, mupirocin) also are used for decolonization of hcws or selected patients colonized with mrsa, as discussed in the mdro guideline , [ ] [ ] [ ] [ ] ii.n. . immunoprophylaxis. certain immunizations recommended for susceptible hcws have decreased the risk of infection and the potential for transmission in health care facilities. , the osha mandate requiring employers to offer hbv vaccination to hcws has played a substantial role in the sharp decline in incidence of occupational hbv infection. , the routine administration of varicella vaccine to hcws has decreased the need to place susceptible hcws on administrative leave after exposure to patients with varicella. in addition, reports of health care-associated transmission of rubella in obstetric clinics , and measles in acute care settings demonstrate the importance of immunization of susceptible hcws against childhood diseases. many states have requirements for vaccination of hcws for measles and rubella in the absence of evidence of immunity. annual influenza vaccine campaigns targeted at patients and hcws in ltcfs and acute care settings have been instrumental in preventing or limiting institutional outbreaks; consequently, increasing attention is being directed toward improving influenza vaccination rates in hcws. , , , [ ] [ ] [ ] transmission of b pertussis in health care facilities has been associated with large and costly outbreaks that include both hcws and patients. , , , , , , , hcws in close contact with infants with pertussis are at particularly high risk because of waning immunity and, until , the absence of a vaccine appropriate for adults. but acellular pertussis vaccines were licensed in the united states in , for use in individuals age to years and the other for use in those age to years. current advisory committee on immunization practices provisional recommendations include immunization of adolescents and adults, especially those in contact with infants under age months and hcws with direct patient contact. , immunization of children and adults will help prevent the introduction of vaccine-preventable diseases into health care settings. the recommended immunization schedule for children is published annually in the january issues of the morbidity and mortality weekly report, with interim updates as needed. , an adult immunization schedule also is available for healthy adults and those with special immunization needs due to high-risk medical conditions. some vaccines are also used for postexposure prophylaxis of susceptible individuals, including varicella, influenza, hepatitis b, and smallpox vaccines. , in the future, administration of a newly developed s aureus conjugate vaccine (still under investigation) to selected patients may provide a novel method of preventing health care-associated s aureus (including mrsa) infections in high-risk groups (eg, hemodialysis patients and candidates for selected surgical procedures). , immune globulin preparations also are used for postexposure prophylaxis of certain infectious agents under specified circumstances (eg, varicella-zoster virus, hbv, rabies, measles and hepatitis a virus , , ). the rsv monoclonal antibody preparation palivizumab may have contributed to controlling a nosocomial outbreak of rsv in one nicu, but there is insufficient evidence to support a routine recommendation for its use in this setting. ii.n. , , , and sars , [ ] [ ] [ ] . effective methods for visitor screening in health care settings have not yet been studied, however. visitor screening is especially important during community outbreaks of infectious diseases and for high-risk patient units. sibling visits are often encouraged in birthing centers, postpartum rooms, pediatric inpatient units, picus, and residential settings for children; in hospital settings, a child visitor should visit only his or her own sibling. screening of visiting siblings and other children before they are allowed into clinical areas is necessary to prevent the introduction of childhood illnesses and common respiratory infections. screening may be passive, through the use of signs to alert family members and visitors with signs and symptoms of communicable diseases not to enter clinical areas. more active screening may include the completion of a screening tool or questionnaire to elicit information related to recent exposures or current symptoms. this information is reviewed by the facility staff, after which the visitor is either permitted to visit or is excluded. family and household members visiting pediatric patients with pertussis and tuberculosis may need to be screened for a history of exposure, as well as signs and symptoms of current infection. potentially infectious visitors are excluded until they receive appropriate medical screening, diagnosis, or treatment. if exclusion is not considered to be in the best interest of the patient or family (ie, primary family members of critically or terminally ill patients), then the symptomatic visitor must wear a mask while in the health care facility and remain in the patient's room, avoiding exposure to others, especially in public waiting areas and the cafeteria. visitor screening is used consistently on hsct units. , however, considering the experience during the sars outbreaks and the potential for pandemic influenza, developing effective visitor screening systems will be beneficial. education concerning respiratory hygiene/cough etiquette is a useful adjunct to visitor screening. ii.n. .b. use of barrier precautions by visitors. the use of gowns, gloves, and masks by visitors in health care settings has not been addressed specifically in the scientific literature. some studies included the use of gowns and gloves by visitors in the control of mdros but did not perform a separate analysis to determine whether their use by visitors had a measurable impact. [ ] [ ] [ ] family members or visitors who are providing care to or otherwise are in very close contact with the patient (eg, feeding, holding) may also have contact with other patients and could contribute to transmission in the absence of effective barrier precautions. specific recommendations may vary by facility or by unit and should be determined by the specific level of interaction. there are tiers of hicpac/cdc precautions to prevent transmission of infectious agents, standard precautions and transmission-based precautions. standard precautions are intended to be applied to the care of all patients in all health care settings, regardless of the suspected or confirmed presence of an infectious agent. implementation of standard precautions constitutes the primary strategy for the prevention of health care-associated transmission of infectious agents among patients and hcws. transmission-based precautions are for patients who are known or suspected to be infected or colonized with infectious agents, including certain epidemiologically important pathogens, which require additional control measures to effectively prevent transmission. because the infecting agent often is not known at the time of admission to a health care facility, transmission-based precautions are used empirically, according to the clinical syndrome and the likely etiologic agents at the time, and then modified when the pathogen is identified or a transmissible infectious etiology is ruled out. examples of this syndromic approach are presented in table . the hicpac/cdc guidelines also include recommendations for creating a protective environment for allogeneic hsct patients. the specific elements of standard and transmission-based precautions are discussed in part ii of this guideline. in part iii, the circumstances in which standard precautions, transmission-based precautions, and a protective environment are applied are discussed. tables and summarize the key elements of these sets of precautions standard precautions combine the major features of universal precautions , and body substance isolation and are based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents. standard precautions include a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed infection status, in any setting in which health care is delivered (table ). these include hand hygiene; use of gloves, gown, mask, eye protection, or face shield, depending on the anticipated exposure; and safe injection practices. also, equipment or items in the patient environment likely to have been contaminated with infectious body fluids must be handled in a manner to prevent transmission of infectious agents (eg, wear gloves for direct contact, contain heavily soiled equipment, properly clean and disinfect or sterilize reusable equipment before use on another patient). the application of standard precautions during patient care is determined by the nature of the hcw-patient interaction and the extent of anticipated blood, body fluid, or pathogen exposure. for some interactions (eg, performing venipuncture), only gloves may be needed; during other interactions (eg, intubation), use of gloves, gown, and face shield or mask and goggles is necessary. education and training on the principles and rationale for recommended practices are critical elements of standard precautions because they facilitate appropriate decision-making and promote adherence when hcws are faced with new circumstances. , [ ] [ ] [ ] [ ] [ ] [ ] an example of the importance of the use of standard precautions is intubation, especially under emergency circumstances when infectious agents may not be suspected, but later are identified (eg, sars-cov, n meningitides). the application of standard precautions is described below and summarized in table . guidance on donning and removing gloves, gowns and other ppe is presented in figure . standard precautions are also intended to protect patients by ensuring that hcws do not carry infectious agents to patients on their hands or via equipment used during patient care. , , the strategy proposed has been termed respiratory hygiene/cough etiquette , and is intended to be incorporated into infection control practices as a new component of standard precautions. the strategy is targeted at patients and accompanying family members and friends with undiagnosed transmissible respiratory infections, and applies to any person with signs of illness including cough, congestion, rhinorrhea, or increased production of respiratory secretions when entering a health care facility. , , the term cough etiquette is derived from recommended source control measures for m tuberculosis. , the elements of respiratory hygiene/cough etiquette include ( ) education of health care facility staff, patients, and visitors; ( ) posted signs, in language(s) appropriate to the population served, with instructions to patients and accompanying family members or friends; ( ) source control measures (eg, covering the mouth/nose with a tissue when coughing and prompt disposal of used tissues, using surgical masks on the coughing person when tolerated and appropriate); ( ) hand hygiene after contact with respiratory secretions; and ( ) spatial separation, ideally . feet, of persons with respiratory infections in common waiting areas when possible. covering sneezes and coughs and placing masks on coughing patients are proven means of source containment that prevent infected persons from dispersing respiratory secretions into the air. , , , masking may be difficult in some settings, (eg, pediatrics), in which case the emphasis by necessity may be on cough etiquette. physical proximity of , feet has been associated with an increased risk for transmission of infections through the droplet route (eg, n meningitidis and group a streptococcus ) and thus supports the practice of distancing infected persons from others who are not infected. the effectiveness of good hygiene practices, especially hand hygiene, in preventing transmission of viruses and reducing the incidence of respiratory infections both within and outside [ ] [ ] [ ] health care settings is summarized in several reviews. , , these measures should be effective in decreasing the risk of transmission of pathogens contained in large respiratory droplets (eg, influenza virus, adenovirus, b pertussis, and m pneumoniae ). although fever will be present in many respiratory infections, patients with pertussis and mild upper respiratory tract infections are often afebrile. therefore, the absence of fever does not always exclude a respiratory infection. patients who have asthma, allergic rhinitis, or chronic obstructive lung disease also may be coughing and sneezing. although these patients often are not infectious, cough etiquette measures are prudent. hcws are advised to observe droplet precautions (ie, wear a mask) and hand hygiene when examining and caring for patients with signs and symptoms of a respiratory infection. hcws who have a respiratory infection are advised to avoid direct patient contact, especially with high-risk patients. if this is not possible, then a mask should be worn while providing patient care. iii.a. .b. safe injection practices. the investigation of large outbreaks of hbv and hcv among patients in ambulatory care facilities in the united states identified a need to define and reinforce safe injection practices. the outbreaks occurred in a private medical practice, a pain clinic, an endoscopy clinic, and a hematology/oncology clinic. the primary breaches in infection control practice that contributed to these outbreaks were reinsertion of used needles into a multiple-dose vial or solution container (eg, saline bag) and use of a single needle/syringe to administer intravenous medication to multiple patients. in of these outbreaks, preparation of medications in the same workspace where used needle/syringes were dismantled also may have been a contributing factor. these and other outbreaks of viral hepatitis could have been prevented by adherence to basic principles of aseptic technique for the preparation and administration of parenteral medications. , these include the use of a sterile, single-use, disposable needle and syringe for each injection given and prevention of contamination of injection equipment and medication. whenever possible, use of single-dose vials is preferred over multiple-dose vials, especially when medications will be administered to multiple patients. outbreaks related to unsafe injection practices indicate that some hcws are unaware of, do not understand, or do not adhere to basic principles of infection control and aseptic technique. a survey of us health care workers who provide medication through injection found that % to % reused the same needle and/or syringe on multiple patients. among the deficiencies identified in recent outbreaks were a lack of oversight of personnel and failure to follow up on reported breaches in infection control practices in ambulatory settings. therefore, to ensure that all hcws understand and adhere to recommended practices, principles of infection control and aseptic technique need to be reinforced in training programs and incorporated into institutional polices that are monitored for adherence. iii.a. .c. infection control practices for special lumbar puncture procedures. in , the cdc investigated cases of postmyelography meningitis that either were reported to the cdc or identified through a survey of the emerging infections network of the infectious disease society of america. blood and/or cerebrospinal fluid of all cases yielded streptococcal species consistent with oropharyngeal flora and there were changes in the csf indices and clinical status indicative of bacterial meningitis. equipment and products used during these procedures (eg, contrast media) were excluded as probable sources of contamination. procedural details available for cases determined that antiseptic skin preparations and sterile gloves had been used. however, none of the clinicians wore a face mask, giving rise to the speculation that droplet transmission of oralpharyngeal flora was the most likely explanation for these infections. bacterial meningitis after myelography and other spinal procedures (eg, lumbar puncture, spinal and epidural anesthesia, intrathecal chemotherapy) has been reported previously. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] as a result, the question of whether face masks should be worn to prevent droplet spread of oral flora during spinal procedures (eg, myelography, lumbar puncture, spinal anesthesia) has been debated. , face masks are effective in limiting the dispersal of oropharyngeal droplets and are recommended for the placement of central venous catheters. in october , hicpac reviewed the evidence and concluded that there is sufficient experience to warrant the additional protection of a face mask for the individual placing a catheter or injecting material into the spinal or epidural space. there are categories of transmission-based precautions: contact precautions, droplet precautions, and airborne precautions. transmission-based precautions are used when the route(s) of transmission is (are) not completely interrupted using standard precautions alone. for some diseases that have multiple routes of transmission (eg, sars), more than transmission-based precautions category may be used. when used either singly or in combination, they are always used in addition to standard precautions. see appendix a for recommended precautions for specific infections. when transmission-based precautions are indicated, efforts must be made to counteract possible adverse effects on patients (ie, anxiety, depression and other mood disturbances, - perceptions of stigma, reduced contact with clinical staff, [ ] [ ] [ ] and increases in preventable adverse events ) to improve acceptance by the patients and adherence by hcws. iii.b. . contact precautions. contact precautions are intended to prevent transmission of infectious agents, including epidemiologically important microorganisms, which are spread by direct or indirect contact with the patient or the patient's environment as described in section i.b. .a. the specific agents and circumstance for which contact precautions are indicated are found in appendix a. the application of contact precautions for patients infected or colonized with mdros is described in the hicpac/cdc mdro guideline. contact precautions also apply where the presence of excessive wound drainage, fecal incontinence, or other discharges from the body suggest an increased potential for extensive environmental contamination and risk of transmission. a single-patient room is preferred for patients who require contact precautions. when a single-patient room is not available, consultation with infection control personnel is recommended to assess the various risks associated with other patient placement options (eg, cohorting, keeping the patient with an existing roommate). in multipatient rooms, $ feet spatial separation between beds is advised to reduce the opportunities for inadvertent sharing of items between the infected/colonized patient and other patients. hcws caring for patients on contact precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient's environment. donning ppe on room entry and discarding before exiting the patient room is done to contain pathogens, especially those that have been implicated in transmission through environmental contamination (eg, vre, c difficile, noroviruses and other intestinal tract pathogens, rsv). , , , , , , iii.b. . droplet precautions. droplet precautions are intended to prevent transmission of pathogens spread through close respiratory or mucous membrane contact with respiratory secretions as described in section i.b. .b. because these pathogens do not remain infectious over long distances in a health care facility, special air handling and ventilation are not required to prevent droplet transmission. infectious agents for which droplet precautions are indicated are listed in appendix a and include b pertussis, influenza virus, adenovirus, rhinovirus, n meningitides, and group a streptococcus (for the first hours of antimicrobial therapy). a single-patient room is preferred for patients who require droplet precautions. when a single-patient room is not available, consultation with infection control personnel is recommended to assess the various risks associated with other patient placement options (eg, cohorting, keeping the patient with an existing roommate). spatial separation of $ feet and drawing the curtain between patient beds is especially important for patients in multibed rooms with infections transmitted by the droplet route. hcws wear a mask (a respirator is not necessary) for close contact with infectious patient; the mask is generally donned on room entry. patients on droplet precautions who must be transported outside of the room should wear a mask if tolerated and follow respiratory hygiene/cough etiquette. iii.b. . airborne precautions. airborne precautions prevent transmission of infectious agents that remain infectious over long distances when suspended in the air (eg, rubeola virus [measles], varicella virus [chickenpox], m tuberculosis, and possibly sars-cov), as described in section i.b. .c and appendix a. the preferred placement for patients who require airborne precautions is in an aiir, a single-patient room equipped with special air handling and ventilation capacity that meet the aia/facility guidelines institute standards for aiirs (ie, monitored negative pressure relative to the surrounding area; air exchanges per hour for new construction and renovation and air exchanges per hour for existing facilities; air exhausted directly to the outside or recirculated through hepa filtration before return). , some states require the availability of such rooms in hospitals, emergency departments, and nursing homes that care for patients with m tuberculosis. a respiratory protection program that includes education about use of respirators, fit testing, and user seal checks is required in any facility with aiirs. in settings where airborne precautions cannot be implemented due to limited engineering resources (eg, physician offices), masking the patient, placing the patient in a private room (eg, office examination room) with the door closed, and providing n or higher-level respirators or masks if respirators are not available for hcws will reduce the likelihood of airborne transmission until the patient is either transferred to a facility with an aiir or returned to the home environment, as deemed medically appropriate. hcws caring for patients on airborne precautions wear a mask or respirator, depending on the disease-specific recommendations (see section ii.e. , table , and appendix a), that is donned before room entry. whenever possible, nonimmune hcws should not care for patients with vaccine-preventable airborne diseases (eg, measles, chickenpox, smallpox). diagnosis of many infections requires laboratory confirmation. because laboratory tests, especially those that depend on culture techniques, often require or more days for completion, transmission-based precautions must be implemented while test results are pending, based on the clinical presentation and likely pathogens. use of appropriate transmission-based precautions at the time a patient develops symptoms or signs of transmissible infection, or arrives at a health care facility for care, reduces transmission opportunities. although it is not possible to identify prospectively all patients needing transmission-based precautions, certain clinical syndromes and conditions carry a sufficiently high risk to warrant their use empirically while confirmatory tests are pending (see table ). icps are encouraged to modify or adapt this table according to local conditions. transmission-based precautions remain in effect for limited periods (ie, while the risk for transmission of the infectious agent persists or for the duration of the illness (see appendix a). for most infectious diseases, this duration reflects known patterns of persistence and shedding of infectious agents associated with the natural history of the infectious process and its treatment. for some diseases (eg, pharyngeal or cutaneous diphtheria, rsv), transmission-based precautions remain in effect until culture or antigen-detection test results document eradication of the pathogen and, for rsv, symptomatic disease is resolved. for other diseases (eg, m tuberculosis), state laws and regulations and health care facility policies may dictate the duration of precautions. in immunocompromised patients, viral shedding can persist for prolonged periods of time (many weeks to months) and transmission to others may occur during that time; therefore, the duration of contact and/or droplet precautions may be prolonged for many weeks. , [ ] [ ] [ ] [ ] [ ] [ ] the duration of contact precautions for patients who are colonized or infected with mdros remains undefined. mrsa is the only mdro for which effective decolonization regimens are available. however, carriers of mrsa who have negative nasal cultures after a course of systemic or topical therapy may resume shedding mrsa in the weeks after therapy. , although early guidelines for vre suggested discontinuation of contact precautions after stool cultures obtained at weekly intervals proved negative, subsequent experiences have indicated that such screening may fail to detect colonization that can persist for . year. , [ ] [ ] [ ] likewise, available data indicate that colonization with vre, mrsa, and possibly mdr-gnb can persist for many months, especially in the presence of severe underlying disease, invasive devices, and recurrent courses of antimicrobial agents. it may be prudent to assume that mdro carriers are colonized permanently and manage them accordingly. alternatively, an interval free of hospitalizations, antimicrobial therapy, and invasive devices (eg, or months) before reculturing patients to document clearance of carriage may be used. determination of the best strategy awaits the results of additional studies. see the hicpac/cdc mdro guideline for a discussion of possible criteria to discontinue contact precautions for patients colonized or infected with mdros. although transmission-based precautions generally apply in all health care settings, exceptions exist. for example, in home care, aiirs are not available. furthermore, family members already exposed to diseases such as varicella and tuberculosis would not use masks or respiratory protection, but visiting hcws would need to use such protection. similarly, management of patients colonized or infected with mdros may necessitate contact precautions in acute care hospitals and in some ltcfs when there is continued transmission, but the risk of transmission in ambulatory care and home care has not been defined. consistent use of standard precautions may suffice in these settings, but more information is needed. a pe is designed for allogeneic hsct patients to minimize fungal spore counts in the air and reduce the risk of invasive environmental fungal infections (see table for specifications). , [ ] [ ] [ ] the need for such controls has been demonstrated in studies of aspergillosis outbreaks associated with construction. , , , , as defined by the aia and presented in detail in the cdc's guideline for environmental infection control in health care facilities, , air quality for hsct patients is improved through a combination of environmental controls that include ( ) hepa filtration of incoming air, ( ) directed room air flow, ( ) positive room air pressure relative to the corridor, ( ) well-sealed rooms (including sealed walls, floors, ceilings, windows, electrical outlets) to prevent flow of air from the outside, ( ) ventilation to provide $ air changes per hour, ( ) strategies to minimize dust (eg, scrubbable surfaces rather than upholstery and carpet, and routinely cleaning crevices and sprinkler heads), and ( ) prohibiting dried and fresh flowers and potted plants in the rooms of hsct patients. the latter is based on molecular typing studies that have found indistinguishable strains of aspergillus terreus in patients with hematologic malignancies and in potted plants in the vicinity of the patients. [ ] [ ] [ ] the desired quality of air may be achieved without incurring the inconvenience or expense of laminar airflow. , to prevent inhalation of fungal spores during periods when construction, renovation, or other dust-generating activities that may be ongoing in and around the health care facility, it has been recommended that severely immunocompromised patients wear a high-efficiency respiratory protection device (eg, an n respirator) when they leave the pe. , , the use of masks or respirators by hsct patients when they are outside of the pe for prevention of environmental fungal infections in the absence of construction has not been evaluated. a pe does not include the use of barrier precautions beyond those indicated for standard precuations and transmission-based precautions. no published reports support the benefit of placing patients undergoing solid organ transplantation or other immunocompromised patients in a pe. these recommendations are designed to prevent transmission of infectious agents among patients and hcws in all settings where health care is delivered. as in other cdc/hicpac guidelines, each recommendation is categorized on the basis of existing scientific data, theoretical rationale, applicability, and, when possible, economic impact. the cdc/hicpac system for categorizing recommendations is as follows: category ia. strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies. category ib. strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale. category ic. required for implementation, as mandated by federal and/or state regulation or standard. category ii. suggested for implementation and supported by suggestive clinical or epidemiologic studies or a theoretical rationale. no recommendation; unresolved issue. practices for which insufficient evidence or no consensus regarding efficacy exists. health care organization administrators should ensure the implementation of recommendations specified in this section. agents into the objectives of the organization's patient and occupational safety programs. assume that every person is potentially infected or colonized with an organism that could be transmitted in the health care setting and apply the following infection control practices during the delivery of health care. iv.a. . during the delivery of health care, avoid unnecessary touching of surfaces in close proximity to the patient to prevent both contamination of clean hands from environmental surfaces and transmission of pathogens from contaminated hands to surfaces. airborne precautions does not need to wear a mask or respirator during transport if the patient is wearing a mask and infectious skin lesions are covered. category ii v.d. . exposure management immunize or provide the appropriate immune globulin to susceptible persons as soon as possible after unprotected contact (ie, exposure) to a patient with measles, varicella, or smallpox: category ia d administer measles vaccine to exposed susceptible persons within hours after the exposure or administer immune globulin within days of the exposure event for high-risk persons in whom vaccine is contraindicated. , - d administer varicella vaccine to exposed susceptible persons within hours after the exposure or administer varicella immune globulin (vzig or an alternative product), when available, within hours for high-risk persons in whom vaccine is contraindicated (eg, immunocompromised patients, pregnant women, newborns whose mother's varicella onset was , days before or within hours after delivery). , - d administer smallpox vaccine to exposed susceptible persons within days after exposure. vi. protective environment (see table airborne infection isolation room (aiir). formerly known as a negative-pressure isolation room, an aiir is a single-occupancy patient care room used to isolate persons with a suspected or confirmed airborne infectious disease. environmental factors are controlled in aiirs to minimize the transmission of infectious agents that are usually transmitted from person to person by droplet nuclei associated with coughing or aerosolization of contaminated fluids. aiirs should provide negative pressure in the room (so that air flows under the door gap into the room), an air flow rate of to air changes per hour (ach) ( ach for existing structures, ach for new construction or renovation), and direct exhaust of air from the room to the outside of the building or recirculation of air through a highefficiency particulate air filter before returning to circulation. ( ambulatory care setting. a facility that provides health care to patients who do not remain overnight; examples include hospital-based outpatient clinics, non-hospital-based clinics and physician offices, urgent care centers, surgicenters, free-standing dialysis centers, public health clinics, imaging centers, ambulatory behavioral health and substance abuse clinics, physical therapy and rehabilitation centers, and dental practices. bioaerosol. an airborne dispersion of particles containing whole or parts of biological entities, including bacteria, viruses, dust mites, fungal hyphae, and fungal spores. such aerosols usually consist of a mixture of monodispersed and aggregate cells, spores, or viruses carried by other materials, such as respiratory secretions and/or inert particles. infectious bioaerosols (ie, those containing biological agents capable of causing an infectious disease) can be generated from human sources (eg, expulsion from the respiratory tract during coughing, sneezing, talking, singing, suctioning, or wound irrigation), wet environmental sources (eg, high-volume air consitioning and cooling tower water with legionella) or dry sources (eg, construction dust with spores produced by aspergillus spp). bioaerosols include large respiratory droplets and small droplet nuclei (cole ec. ajic ; : - ) . caregiver.. any person who is not an employee of an organization, is not paid, and provides or assists in providing health care to a patient (eg, family member, friend) and acquire technical training as needed based on the tasks that must be performed. cohorting. in the context of this guideline, this term applies to the practice of grouping patients infected or colonized with the same infectious agent together to confine their care to one area and prevent contact with susceptible patients (cohorting patients). during outbreaks, health care personnel may be assigned to a cohort of patients to further limit opportunities for transmission (cohorting staff). colonization. proliferation of microorganisms on or within body sites without detectable host immune response, cellular damage, or clinical expression. the presence of a microorganism within a host may occur with varying durations but may become a source of potential transmission. in many instances, colonization and carriage are synonymous. droplet nuclei. microscopic particles , mm in size that are the residue of evaporated droplets and are produced when a person coughs, sneezes, shouts, or sings. these particles can remain suspended in the air for prolonged periods and can be carried on normal air currents in a room or beyond, to adjacent spaces or areas receiving exhaust air. engineering controls. removal or isolation of a workplace hazard through technology. an airborne infection isolation room, a protective environment, engineered sharps injury prevention device, and a sharps container are examples of engineering controls. epidemiologically important pathogen. an infectious agent that has one or more of the following characteristics: ( ) readily transmissible, ( ) a proclivity toward causing outbreaks, ( ) possible association with a severe outcome, and ( ) difficult to treat. examples include acinetobacter spp, aspergillus spp, burkholderia cepacia, clostridium difficile, klebsiella or enterobacter spp, extended-spectrum beta-lactamaseproducing gram-negative bacilli, methicillin-resistant staphylococcus aureus, pseudomonas aeruginosa, vancomycin-resistant enterococci, vancomycin-resistant staphylococcus aureus, influenza virus, respiratory syncytial virus, rotavirus, severe acute respiratory syndrome coronavirus, noroviruses, and the hemorrhagic fever viruses. hand hygiene. a general term that applies to any one of the following: ( ) handwashing with plain (nonantimicrobial) soap and water, ( ) antiseptic handwashing (soap containing antiseptic agents and water), ( ) antiseptic handrub (waterless antiseptic product, most often alcohol-based, rubbed on all surfaces of hands), or ( ) surgical hand antisepsis (antiseptic handwash or antiseptic handrub performed preoperatively by surgical personnel to eliminate transient hand flora and reduce resident hand flora). health care-associated infection (hai). an infection that develops in a patient who is cared for in any setting where health care is delivered (eg, acute care hospital, chronic care facility, ambulatory clinic, dialysis center, surgicenter, home) and is related to receiving health care (ie, was not incubating or present at the time health care was provided). in ambulatory and home settings, hai refers to any infection that is associated with a medical or surgical intervention. because the geographic location of infection acquisition is often uncertain, the preferred term is considered to be health care-associated rather than health care-acquired. healthcare epidemiologist. a person whose primary training is medical (md, do) and/or masters-or doctorate-level epidemiology who has received advanced training in health care epidemiology. typically these professionals direct or provide consultation to an infection control program in a hospital, long-term care facility, or health care delivery system (also see infection control professional). health care personnel, health care worker (hcw). any paid or unpaid person who works in a health care setting (eg, any person who has professional or technical training in a health care-related field and provides patient care in a health care setting or any person who provides services that support the delivery of health care such as dietary, housekeeping, engineering, maintenance personnel). hematopoietic stem cell transplantation (hsct). any transplantation of blood-or bone marrow-derived hematopoietic stem cells, regardless of donor type (eg, allogeneic or autologous) or cell source (eg, bone marrow, peripheral blood, or placental/umbilical cord blood), associated with periods of severe immunosuppression that vary with the source of the cells, the intensity of chemotherapy required, and the presence of graft versus host disease (mmwr ; : rr- ). high-efficiency particulate air (hepa) filter. an air filter that removes . . % of particles . . mm (the most penetrating particle size) at a specified flow rate of air. hepa filters may be integrated into the central air handling systems, installed at the point of use above the ceiling of a room, or used as portable units (mmwr ; : rr- ). home care. a wide range of medical, nursing, rehabilitation, hospice, and social services delivered to patients in their place of residence (eg, private residence, senior living center, assisted living facility). home health care services include care provided by home health aides and skilled nurses, respiratory therapists, dieticians, physicians, chaplains, and volunteers; provision of durable medical equipment; home infusion therapy; and physical, speech, and occupational therapy. immunocompromised patient. a patient whose immune mechanisms are deficient because of a congenital or acquired immunologic disorder (eg, human immunodeficiency virus infection, congenital immune deficiency syndromes), chronic diseases such as diabetes mellitus, cancer, emphysema, or cardiac failure, intensive care unit care, malnutrition, and immunosuppressive therapy of another disease process [eg, radiation, cytotoxic chemotherapy, anti-graft rejection medication, corticosteroids, monoclonal antibodies directed against a specific component of the immune system]). the type of infections for which an immunocompromised patient has increased susceptibility is determined by the severity of immunosuppression and the specific component(s) of the immune system that is affected. patients undergoing allogeneic hematopoietic stem cell transplantation and those with chronic graft versus host disease are considered the most vulnerable to health care-associated infections. immunocompromised states also make it more difficult to diagnose certain infections (eg, tuberculosis) and are associated with more severe clinical disease states than persons with the same infection and a normal immune system. infection. the transmission of microorganisms into a host after evading or overcoming defense mechanisms, resulting in the organism's proliferation and invasion within host tissue(s). host responses to infection may include clinical symptoms or may be subclinical, with manifestations of disease mediated by direct organisms pathogenesis and/or a function of cell-mediated or antibody responses that result in the destruction of host tissues. infection control and prevention professional (icp). a person whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control. responsibilities may include collection, analysis, and feedback of infection data and trends to health care providers; consultation on infection risk assessment, prevention, and control strategies; performance of education and training activities; implementation of evidence-based infection control practices or those mandated by regulatory and licensing agencies; application of epidemiologic principles to improve patient outcomes; participation in planning renovation and construction projects (eg, to ensure appropriate containment of construction dust); evaluation of new products or procedures on patient outcomes; oversight of employee health services related to infection prevention; implementation of preparedness plans; communication within the health care setting, with local and state health departments, and with the community at large concerning infection control issues; and participation in research. certification in infection control is available through the certification board of infection control and epidemiology. infection control and prevention program. a multidisciplinary program that includes a group of activities to ensure that recommended practices for the prevention of health care-associated infections are implemented and followed by health care workers, making the health care setting safe from infection for patients and health care personnel. the joint commission on accreditation of healthcare organizations requires the following components of an infection control program for accreditation: ( ) surveillance: monitoring patients and health care personnel for acquisition of infection and/or colonization; ( ) investigation: identification and analysis of infection problems or undesirable trends; ( ) prevention: implementation of measures to prevent transmission of infectious agents and to reduce risks for device-and procedure-related infections; ( ) control: evaluation and management of outbreaks; and ( ) reporting: provision of information to external agencies as required by state and federal laws and regulations (see http://www.jcaho.org). the infection control program staff has the ultimate authority to determine infection control policies for a health care organization with the approval of the organization's governing body. long-term care facility (ltcf). a residential or outpatient facility designed to meet the biopsychosocial needs of persons with sustained self-care deficits. these include skilled nursing facilities, chronic disease hospitals, nursing homes, foster and group homes, institutions for the developmentally disabled, residential care facilities, assisted living facilities, retirement homes, adult day health care facilities, rehabilitation centers, and long-term psychiatric hospitals. mask. a term that applies collectively to items used to cover the nose and mouth and includes both procedure masks and surgical masks (see http://www.fda. gov/cdrh/ode/guidance/ .html# ). multidrug-resistant organism (mdro). in general, a bacterium (excluding mycobacterium tuberculosis) that is resistant to or more classes of antimicrobial agents and usually is resistant to all but or commercially available antimicrobial agents (eg, methicillin-resistant staphylococcus aureus, vancomycin-resistant enterococci, extended-spectrum beta-lactamase-producing or intrinsically resistant gram-negative bacilli). nosocomial infection. derived from greek words, ''nosos'' (disease) and ''komeion'' (to take care of), refers to any infection that develops during or as a result of an admission to an acute care facility (hospital) and was not incubating at the time of admission. personal protective equipment (ppe). a variety of barriers used alone or in combination to protect mucous membranes, skin, and clothing from contact with infectious agents. ppe includes gloves, masks, respirators, goggles, face shields, and gowns. procedure mask. a covering for the nose and mouth that is intended for use in general patient care situations. these masks generally attach to the face with ear loops rather than ties or elastic. unlike surgical masks, procedure masks are not regulated by the food and drug administration. protective environment. a specialized patient care area, usually in a hospital, with a positive air flow relative to the corridor (ie, air flows from the room to the outside adjacent space). the combination of high-efficiency particulate air filtration, high numbers (. ) of air changes per hour, and minimal leakage of air into the room creates an environment that can safely accommodate patients with a severely compromised immune system (eg, those who have received allogeneic hemopoietic stem cell transplantation) and decrease the risk of exposure to spores produced by environmental fungi. other components include use of scrubbable surfaces instead of materials such as upholstery or carpeting, cleaning to prevent dust accumulation, and prohibition of fresh flowers or potted plants. quasi-experimental study. a study undertaken to evaluate interventions but do not use randomization as part of the study design. these studies are also referred to as nonrandomized, pre-/postintervention study designs. these studies aim to demonstrate causality between an intervention and an outcome but cannot achieve the level of confidence concerning an attributable benefit obtained through a randomized controlled trial. in hospitals and public health settings, randomized control trials often cannot be implemented due to ethical, practical, and urgency reasons; therefore, quasi-experimental design studies are commonly used. however, even if an intervention appears to be effective statistically, the question can be raised as to the possibility of alternative explanations for the result. such a study design is used when it is not logistically feasible or ethically possible to conduct a randomized controlled trial, (eg, during outbreaks). within the classification of quasi-experimental study designs, there is a hierarchy of design features that may contribute to validity of results (harris et al. cid : : . residential care setting. a facility in which people live, minimal medical care is delivered, and the psychosocial needs of the residents are provided for. respirator. a personal protective device worn by health care personnel over the nose and mouth to protect them from acquiring airborne infectious diseases due to inhalation of infectious airborne particles , mm in size. these include infectious droplet nuclei from patients with mycobacterium tuberculosis, variola virus [smallpox], or severe acute respiratory syndrome and dust particles that contain infectious particles, such as spores of environmental fungi (eg, aspergillus spp). the centers for disease control and prevention's national institute for occupational safety and health (niosh) certifies respirators used in health care settings (see http://www.cdc.gov/niosh/topics/respirators/). the n disposable particulate, air-purifying respirator is the type used most commonly by health care personnel. other respirators used include n- and n- particulate respirators, powered air-purifying respirators with high-efficiency filters, and nonpowered fullfacepiece elastomeric negative pressure respirators. a listing of niosh-approved respirators can be found at http://www.cdc.gov/niosh/npptl/respirators/disp_part/ particlist.html. respirators must be used in conjunction with a complete respiratory protection program, as required by the occupational safety and health administration, which includes fit testing, training, proper selection of respirators, medical clearance, and respirator maintenance. respiratory hygiene/cough etiquette. a combination of measures designed to minimize the transmission of respiratory pathogens through droplet or airborne routes in health care settings. the components of respiratory hygiene/cough etiquette are ( ) covering the mouth and nose during coughing and sneezing, ( ) using tissues to contain respiratory secretions with prompt disposal into a no-touch receptacle, ( ) offering a surgical mask to persons who are coughing to decrease contamination of the surrounding environment, and ( ) turning the head away from others and maintaining spatial separation (ideally . feet) when coughing. these measures are targeted to all patients with symptoms of respiratory infection and their accompanying family members or friends beginning at the point of initial encounter with a health care setting (eg, reception/triage in emergency departments, ambulatory clinics, health care provider offices). (srinivasin a iche ; : ; http://www.cdc.gov/flu/ professionals/infectioncontrol/resphygiene.htm). safety culture. shared perceptions of workers and management regarding the level of safety in the work environment. a hospital safety climate includes the following organizational components: ( ) senior management support for safety programs, ( ) absence of workplace barriers to safe work practices, ( ) cleanliness and orderliness of the worksite, ( ) minimal conflict and good communication among staff members, ( ) frequent safety-related feedback/training by supervisors, and ( ) availability of ppe and engineering controls. source control. the process of containing an infectious agent either at the portal of exit from the body or within a confined space. the term is applied most frequently to containment of infectious agents transmitted by the respiratory route but could apply to other routes of transmission, (eg, a draining wound, vesicular or bullous skin lesions). respiratory hygiene/cough etiquette that encourages individuals to ''cover your cough'' and/or wear a mask is a source control measure. the use of enclosing devices for local exhaust ventilation (eg, booths for sputum induction or administration of aerosolized medication) is another example of source control. standard precautions. a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed diagnosis or presumed infection status. standard precautions represents a combination and expansion of universal precautions and body substance isolation. standard precautions are based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents. standard precautions include hand hygiene and, depending on the anticipated exposure, use of gloves, gown, mask, eye protection, or face shield. in addition, equipment or items in the patient environment likely to have been contaminated with infectious fluids must be handled in a manner to prevent transmission of infectious agents (eg, wear gloves for handling, contain heavily soiled equipment, properly clean and disinfect or sterilize reusable equipment before use on another patient). surgical mask. a device worn over the mouth and nose by operating room personnel during surgical procedures to protect both surgical patients and operating room personnel from transfer of microorganisms and body fluids. surgical masks also are used to protect health care personnel from contact with large infectious droplets (. mm in size). according to draft guidance issued by the food and drug administration on may , , surgical masks are evaluated using standardized testing procedures for fluid resistance, bacterial filtration efficiency, differential pressure (air exchange), and flammability to mitigate the risks to health associated with the use of surgical masks. these specifications apply to any masks that are labeled surgical, laser, isolation, or dental or medical procedure (http://www.fda.gov/cdrh/ode/guidance/ .html# ). surgical masks do not protect against inhalation of small particles or droplet nuclei and should not be confused with particulate respirators that are recommended for protection against selected airborne infectious agents (eg, mycobacterium tuberculosis). other species s use contact precautions for diapered or incontinent persons for the duration of illness or to control institutional outbreaks. giardia lamblia s use contact precautions for diapered or incontinent persons for the duration of illness or to control institutional outbreaks. noroviruses s use contact precautions for diapered or incontinent persons for the duration of illness or to control institutional outbreaks. persons who clean areas heavily contaminated with feces or vomitus may benefit from wearing masks, because virus can be aerosolized from these body substances; , , ensure consistent environmental cleaning and disinfection with focus on restrooms even when apparently unsoiled. , hypochlorite solutions may be required when there is continued transmission. [ ] [ ] [ ] alcohol is less active, but there is no evidence that alcohol antiseptic handrubs are not effective for hand decontamination. cohorting of affected patients to separate airs paces and toilet facilities may help interrupt transmission during outbreaks. rotavirus c di ensure consistent environmental cleaning and disinfection and frequent removal of soiled diapers. prolonged shedding may occur in both immunocompetent and immunocompromised children and the elderly. also for asymptomatic, exposed infants delivered vaginally or by c-section and if mother has active infection and membranes have been ruptured for more than to hours until infant surface cultures obtained at to hours of age negative after hours of incubation. susceptible hcws should not enter room if immune caregivers are available; no recommendation for face protection of immune hcws; no recommendation for type of protection (ie, surgical mask or respirator) for susceptible hcws. in an immunocompromised host with varicella pneumonia, prolong the duration of precautions for duration of illness. postexposure prophylaxis: provide postexposure vaccine as soon as possible but within hours; for susceptible exposed persons for whom vaccine is contraindicated (immunocompromised persons, pregnant women, newborns whose mother's varicella onset is # days before delivery or within hours after delivery) provide vzig, when available, within hours; if unavailable, use ivig. provide airborne precautions for exposed susceptible persons and exclude exposed susceptible health care workers beginning days after first exposure until days after last exposure or if received vzig, regardless of postexposure vaccination. variola (see smallpox) vibrio parahaemolyticus (see gastroenteritis) vincent's angina (trench mouth) s viral hemorrhagic fevers due to lassa, ebola, marburg, crimean-congo fever viruses s, d, c di single-patient room preferred. emphasize: use of sharps safety devices and safe work practices, hand hygiene; barrier protection against blood and body fluids on entry into room (single gloves and fluid-resistant or impermeable gown, face/eye protection with masks, goggles or face shields), and appropriate waste handling. use n or higher-level respirator when performing aerosol-generating procedures. largest viral load in final stages of illness when hemorrhage may occur; additional ppe, including double gloves, leg and shoe coverings may be used, especially in resource-limited settings where options for cleaning and laundry are limited. notify public health officials immediately if ebola is suspected. , , , also see table *type of precautions: a, airborne precautions; c, contact; d, droplet; s, standard; when a, c, and d are specified, also use s. y duration of precautions: cn, until off antimicrobial treatment and culture-negative; di, duration of illness (with wound lesions, di means until wounds stop draining); de, until environment completely decontaminated; u, until time 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nosocomial infections the ability of hospital ventilation systems to filter aspergillus and other fungi following a building implosion increased catheter-related bloodstream infection rates after the introduction of a new mechanical valve intravenous access port joint commision on accreditation of healthcare organizations. comprehensive accredication manual for hospitals: the official handbook new technology for detecting multidrugresistant pathogens in the clinical microbiology laboratory employee health and infection control nosocomial outbreak of pseudomonas cepacia associated with contamination of reusable electronic ventilator temperature probes ventilator temperature sensors: an unusual source of pseudomonas cepacia in nosocomial infection centers for disease control and prevention. bronchoscopy-related infections and pseudoinfections decontaminated single-use devices: an oxymoron that may be placing patients at risk for cross-contamination centers for disease control and 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efficacy of selected hand hygiene agents used to remove bacillus atrophaeus (a surrogate of bacillus anthracis) from contaminated hands banning artificial nails from health care settings prospective, controlled study of vinyl glove use to interrupt clostridium difficile nosocomial transmission latex glove penetration by pathogens: a review of the literature pcr-based method for detecting viral penetration of medical exam gloves association of contaminated gloves with transmission of acinetobacter calcoaceticus var. anitratus in an intensive care unit epidemiology and prevention of pediatric viral respiratory infections in health-care institutions nosocomial transmission of rotavirus from patients admitted with diarrhea safety and cleaning of medical materials and devices surface fixation of dried blood by glutaraldehyde and peracetic acid role of environmental contamination in the transmission of vancomycin-resistant enterococci disinfection of hospital rooms contaminated with vancomycin-resistant enterococcus faecium role of environmental contamination as a risk factor for acquisition of vancomycin-resistant enterococci in patients treated in a medical intensive care unit federal insecticide, fungicide, and rodenticidal act usc et seq is methicillin-resistant staphylococcus aureus (mrsa) contamination of ward-based computer terminals a surrogate marker for nosocomial mrsa transmission and handwashing compliance? transfer of bacteria from fabrics to hands and other fabrics: development and application of a quantitative method using staphylococcus aureus as a model evaluation of bedmaking-related airborne and surface methicillin-resistant staphylococcus aureus contamination bacterial contamination on the surface of hospital linen chutes designing linen chutes to reduce spread of infectious organisms iatrogenic contamination of multidose vials in simulated use: a reassessment of current patient injection technique a large outbreak of hepatitis b virus infections associated with frequent injections at a physician's office a large nosocomial outbreak of hepatitis c and hepatitis b among patients receiving pain remediation treatments patient-to-patient transmission of hepatitis c virus through the use of multidose vials during general anesthesia an outbreak of hepatitis c virus infections among outpatients at a hematology/oncology clinic streptococcal meningitis following myelogram procedures a prospective study to determine whether cover gowns in addition to gloves decrease nosocomial transmission of vancomycin-resistant enterococci in an intensive care unit parainfluenza virus infections after hematopoietic stem cell transplantation: risk factors, response to antiviral therapy, and effect on transplant outcome parainfluenza virus infection after stem cell transplant: relevance to outcome of rapid diagnosis and ribavirin treatment serial observations of chronic rotavirus infection in an immunodeficient child an outbreak of imipenem-resistant acinetobacter baumannii in critically ill surgical patients epidemiology of methicillin-resistant staphylococcus aureus at a university hospital in the canary islands nosocomial acquisition of methicillin-resistant staphylococcus aureus during an outbreak of severe acute respiratory syndrome increase in methicillin-resistant staphylococcus aureus acquisition rate and change in pathogen pattern associated with an outbreak of severe acute respiratory syndrome an outbreak of mupirocin-resistant staphylococcus aureus on a dermatology ward associated with an environmental reservoir risk of secondary meningococcal disease in health-care workers an outbreak of measles at an international sporting event with airborne transmission in a domed stadium an outbreak of airborne nosocomial varicella herpes zoster causing varicella (chickenpox) in hospital employees: cost of a casual attitude identification of factors that disrupt negative air pressurization of respiratory isolation rooms an evaluation of hospital special ventilation room pressures nosocomial transmission of tuberculosis associated with a draining abscess an outbreak of tuberculosis among hospital personnel caring for a patient with a skin ulcer secondary measles vaccine failure in healthcare workers exposed to infected patients a cluster of primary varicella cases among healthcare workers with false-positive varicella zoster virus titers airborne transmission of nosocomial varicella from localized zoster zoster-causing varicella: current dangers of contagion without isolation detection of aerosolized varicella-zoster virus dna in patients with localized herpes zoster measles vaccination after exposure to natural measles use of live measles virus vaccine to abort an expected outbreak of measles within a closed population measles, mumps, and rubella vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps: recommendations of the advisory committee on immunization practices (acip) general recommendations on immunization: recommendations of the advisory committee on immunization practices (acip) postexposure effectiveness of varicella vaccine postexposure varicella vaccination in siblings of children with active varicella centers for disease control and preverntion. vaccinia (smallpox) vaccine: recommendations of the advisory committee on immunization practices (acip) smallpox vaccination: a review. part i: background, vaccination technique, normal vaccination and revaccination, and expected normal reactions smallpox in tripolitania, : an epidemiological and clinical study of cases, including trials of penicillin treatment ventilation for protection of immune-compromised patients efficacy of portable filtration units in reducing aerosolized particles in the size range of mycobacterium tuberculosis dolin r, editors. mandell, douglas and bennett's principles and practice of infectious diseases control of communicable diseases manual outbreak of amebiasis in a family in the netherlands parasitic disease control in a residential facility for the mentally retarded: failure of selected isolation procedures west nile virus: epidemiology, clinical presentation, diagnosis, and prevention person-to-person transmission of brucella melitensis isolation of brucella melitensis from human sperm prevention of laboratoryacquired brucellosis chlamydia pneumoniae as a new source of infectious outbreaks in nursing homes an epidemic of infections due to chlamydia pneumoniae in military conscripts an outbreak of surgical wound infections due to clostridium perfringens acquisition of coccidioidomycosis at necropsy by inhalation of coccidioidal endospores donor-related coccidioidomycosis in organ transplant recipients centers for disease control and prevention. acute hemorrhagic conjunctivitis outbreak caused by coxsackievirus a outbreak of adenovirus type in a neonatal intensive care unit an outbreak of epidemic keratoconjunctivtis in a pediatric unit due to adenovirus type a large outbreak of epidemic keratoconjunctivitis: problems in controlling nosocomial spread nosocomial transmission of cryptococcosis cryptococcal endophthalmitis after corneal transplantation probable transmission of norovirus on an airplane centers for disease control and prevention. prevention of hepatitis a through active or passive immunization: recommendations of the advisory committee on immunization practices (acip) hepatitis a outbreak in a neonatal intensive care unit: risk factors for transmission and evidence of prolonged viral excretion among preterm infants excretion of hepatitis a virus in the stools of hospitalized hepatitis patients hospital outbreak of hepatitis e herpes simplex virus infections neonatal herpes infection: diagnosis, treatment and prevention human metapneumovirus infection in the united states: clinical manifestations associated with a newly emerging respiratory infection in children listeria moncytogenes cross-contamination in a nursery neonatal listeriosis due to cross-infection confirmed by isoenzyme typing and dna fingerprinting outbreak of neonatal listeriosis associated with mineral oil neonatal cross-infection with listeria monocytogenes nosocomial malaria and saline flush plasmodium falciparum malaria transmitted in hospital through heparin locks nosocomial malaria from contamination of a multidose heparin container with blood hospital-acquired malaria transmitted by contaminated gloves clustering of necrotizing enterocolitis: interruption by infection-control measures how contagious is necrotizing enterocolitis? an outbreak of rotavirus-associated neonatal necrotizing enterocolitis increased risk of illness among nursery staff caring for neonates with necrotizing enterocolitis outbreak of adenovirus pneumonia among adult residents and staff of a chronic care psychiatric facility nosocomial adenovirus infection: molecular epidemiology of an outbreak a recent outbreak of adenovirus type infection in a chronic inpatient facility for the severely handicapped an outbreak of multidrugresistant pneumococcal pneumonia and bacteremia among unvaccinated nursing home residents human-to-human transmission of rabies virus by corneal transplant human rabies prevention, united states, : recommendations of the advisory committee on immunization practices (acip) rhinovirus and the lower respiratory tract concurrent outbreaks of rhinovirus and respiratory syncytial virus in an intensive care nursery: epidemiology and associated risk factors rhinovirus infection associated with serious lower respiratory illness in patients with bronchopulmonary dysplasia nosocomial ringworm in a neonatal intensive care unit: a nurse and her cat nosocomial transmission of trichophyton tonsurans tinea corporis in a rehabilitation hospital molecular epidemiology of staphylococcal scalded skin syndrome in premature infants an outbreak of fatal nosocomial infections due to group a streptococcus on a medical ward an outbreak of group a streptococcal infection among health care workers clusters of invasive group a streptococcal infections in family, hospital, and nursing home settings isolation techniques for use in hospitals us government printing office rethinking the role of isolation practices in the prevention of nosocomial infections the authors and hicpac gratefully acknowledge dr larry strausbaugh for his many contributions and valued guidance in the preparation of this guideline. the mode(s) and risk of transmission for each specific disease agent listed in this appendix were reviewed. principle sources consulted for the development of disease-specific recommendations for the appendix included infectious disease manuals and textbooks. , , the published literature was searched for evidence of person-to-person transmission in health care and non-health care settings with a focus on reported outbreaks that would assist in developing recommendations for all settings where health care is delivered. the following criteria were used to assign transmission-based precautions categories: d a transmission-based precautions category was assigned if there was strong evidence for person-to-person transmission via droplet, contact, or airborne routes in health care or non-health care settings and/or if patient factors (eg, diapered infants, diarrhea, draining wounds) increased the risk of transmission. d transmission-based precautions category assignments reflect the predominant mode(s) of transmission. d if there was no evidence for person-to-person transmission by droplet, contact or airborne routes, then standard precautions were assigned. d if there was a low risk for person-to-person transmission and no evidence of health care-associated transmission, then standard precautions were assigned. d standard precautions were assigned for bloodborne pathogens (eg, hbv, hcv, hiv) in accordance with cdc recommendations for universal precautions issued in . subsequent experience has confirmed the efficacy of standard precautions to prevent exposure to infected blood and body fluid. , , additional information relevant to use of precautions was added in the comments column to assist the caregiver in decision-making. citations were added as needed to support a change in or provide additional evidence for recommendations for a specific disease and for new infectious agents (eg, sars-cov, avian influenza) that have been added to appendix a. the reader may refer to more detailed discussion concerning modes of transmission and emerging pathogens in the background text and for mdro control in the mdro guideline. key: cord- -ilhr iu authors: nan title: isev abstract book date: - - journal: nan doi: . / . . sha: doc_id: cord_uid: ilhr iu nan introduction: primary tumours secrete large amounts of extracellular vesicles (evs), which play critical roles in preparing distant sites for a pre-metastatic niche formation, thereby promoting metastasis and even determining metastatic organotropism. whether biogenesis, secretion rates and organotropism of evs are linked remains unknown. we have recently shown that ral gtpases control evs secretion in nematodes as well as in mouse mammary tumour cells (hyenne et al. jcb ) . since both rala and ralb are overexpressed or over-activated in various human cancers, we aimed to investigate the mechanisms by which these two gtpases control evs secretion and to determine how this affects metastatic progression, with a focus on breast cancer. methods: we used t mouse mammary carcinoma cells knocked down for either rala or ralb and determined their ability to induce orthotopic tumours and metastasis in a syngeneic mouse model. in vitro, we investigated ev secretion mechanisms using confocal and electron microscopy (em). evs were isolated either by uc or sec and characterized by nta, em, rna sequencing and mass spectrometry. the function of evs was assessed using a transwell assay. finally, we tracked the organotropism of fluorescently labelled evs and their capacity to induce pre-metastatic niches in mice. results: we show that rala and ralb promote lung metastasis of breast cancer cells in mice without affecting their invasive behaviours. we found that rala and ralb control the biogenesis of exosomes, by acting on the formation of multi-vesicular bodies though the phospholipase pld . as a consequence, knock down of rala or ralb reduces the levels of secreted evs and modifies their rna and protein contents. these differences alter the pro-tumoural function of evs, as demonstrated with an in vitro permeability test. importantly, we show in vivo that evs from rala or ralb depleted cells have a decreased lung organotropism and, as a consequence, are less efficient in priming lung metastasis. finally, we show that high expression of rala or ralb is associated with a bad prognosis in human breast cancer patients. summary/conclusion: altogether, our study identifies ral gtpases as central molecules linking the mechanisms of evs secretion, their dissemination and their capacity to promote metastasis. nuclear proteins are recruited into tumour-derived extracellular vesicles upon expression of tetraspanin tspan introduction: tetraspanin tspan is a transmembrane protein that exhibits a unique expression pattern, being overexpressed in many cancer types, but undetectable in most healthy tissues. although there is increasing evidence of an effect of tspan in invasion, metastasis, and regulation of extracellular vesicle cargo, the molecular mechanisms of tspan are yet not fully understood. methods: to study the function of tspan , we have established a fibrosarcoma model consisting of the parental cell line (ht ) and its derivatives expressing tspan (ht -tspan ) either fused with different fluorescent tags or tag-free. life imaging, sted and storm microscopy were used to determine the intracellular localization of tspan . co-immunoprecipitation from nuclei lysates was performed to detect direct and indirect interacting partners of tspan . small evs were purified from cell-conditioned media using sec and subjected to mass spectroscopy and ngs for a comprehensive comparative analysis of the proteome and transcriptome of the evs. results: the results of the proteome analysis showed a strong effect in the protein cargo of evs upon tspan expression. remarkably, among of the most regulated targets, several histones and ribosomal proteins were enriched in the evs derived from ht -tspan cells. in line with this finding, life imaging and super-resolution microscopy revealed that, while a majority of the intracellular tspan is located on the cell membrane or intracellular membranes, -as it is known for other tetraspanins-, a portion of tspan is located on the nuclear envelope. in fact, several histones co-immunoprecipitated with tspan , indicating their interaction. summary/conclusion: our data show that the expression of tspan in the tumour cells greatly impacts ev cargo. moreover, localization of tspan on the nuclear envelope, together with the enhanced recruitment of nuclear and ribosomal proteins to the evs, suggests a new mechanism of action of tspan . introduction: extracellular vesicles (evs) modulate tissue development, regeneration and disease through the transfer of proteins, nucleic acids and lipids between cells. currently, the mechanism of cytosolic delivery of ev cargo is largely unknown. here, we unravel how evs release their cargo in recipient cells. methods: evs were isolated from gfp-cd and cd -rfp expressing hek t cells by ultracentrifugation. gfp-cd and cd -rfp evs were added to hek t cells stably expressing anti-gfp fluobody and fluorescently tagged galectin- , respectively. clem and fluorescence microscopy were employed to visualize fluorescent markers in recipient cells. bafilomycin a and u a were used to inhibit endosomal acidification and cholesterol export from lysosomes, respectively. results: fluorescent galectin- which binds to betagalactosides present at the luminal side of endosomes was used to detect endosomal permeabilization. the absence of galectin- recruitment to endosomes in presence of cd -rfp evs showed that endosome permeabilization is not the mechanism behind ev cargo release. gfp-cd ev addition to cells expressing anti-gfp fluobodies resulted in the formation of fluobody punctae, reflecting cytosolic exposure of ev cargo. subsequent clem of the fluobody punctae revealed endosomes as the underlying cellular compartments from where cargo release takes place. neutralization of endosomal ph and accumulation of endosomal cholesterol blocked cargo release, showing that ev cargo release is dependent on endosomal ph and cholesterol level. summary/conclusion: we show that genetically encoded cytosolic probes and clem offer an excellent approach to study both the mechanism and efficiency of ev cargo release in cells. we provide experimental evidence that ev cargo release occurs from endosomes. funding: the research was supported by dutch technology foundation ttw and netherlands organization for scientific research nwo, de cock-hadders stichting, and erasmus mundus namaste scholarship. healthy humans. to determine cut-off values for diagnoses, reference intervals of evs in plasma are needed. to establish such reference intervals, ( ) a significant number of healthy donors should be included, ( ) the presence of non-ev particles, residual platelets, lipoproteins, and haemolysis should be quantified, ( ) flow cytometry signals should be in si units. the long-term aim of this study is to determine reference intervals of ev concentrations in human plasma within known dynamic ranges of the detectors. methods: ( ) to establish a clinical reference, we collected blood from healthy volunteers and prepared platelet-free plasma. ( ) we performed quality control measurements including residual platelet count, serum index, and lipid spectrum. ( ) we measured all samples by flow cytometry (apogee a -micro) and used custom software (matlab r b) to automate calibration of all signals and data processing. scatter signals were calibrated in comparable units of scattering crosssection (nm ) and diameter (nm). fluorescence signals were calibrated in units of molecules of equivalent soluble fluorophores (mesf). results: the quality controls showed that most residual platelet concentrations ranged from ^ to ^ per ml except for one outlier, while the serum index and lipid spectrum were normally distributed. preliminary results of the first donors analysed, show that within the ev size range of - , nm, the median concentration of cd + evs is . • ^ per ml (apc> mesf), cd p+ evs is . • ^ per ml (pe> mesf), cd a+ evs is . • ^ per ml (pe> mesf), and cd + evs is . • ^ per ml (apc> mesf). summary/conclusion: we have developed reliable procedures for establishing reference intervals of ev concentrations, within a well-defined size and fluorescence intensity range, in human plasma by flow cytometry. we are currently applying these procedures to samples to obtain, for the first time, ev reference intervals for human plasma. funding: pol, e. van der is supported by the netherlands organisation for scientific research -domain applied and engineering sciences (nwo-ttw), research programmes veni . introduction: the use of extracellular vesicles for diagnostic and therapeutic applications has seen a major interest increase in recent years because of their capacity to exchange components such as nucleic acids, lipids and proteins between cells. isolation of a pure population of evs is the first step in studying their physiological functions since contamination of ev preparations with non-ev proteins can lead to incorrect conclusions about their biological activities. we have developed a new method termed tangential flow for analyte capture (tfac) using ultrathin nanomembranes to purify extracellular vesicles from pure, highly complex biological fluids such as blood plasma, resulting in a new method for extracellular vesicle purification. methods: the tff microfluidic devices are assembled through a layer stack process using patterned polydimethylsiloxane (pdms) sheets with the membranes sandwiched between top and bottom channels. undiluted plasma was tested in both normal flow filtration (nff) and tangential flow filtration (tff) modes on ultrathin nanomembranes. we have utilized a pore patterning technique called nanosphere lithography (nsl) that uses close-packing of nanoscale beads to pattern pores in an ultrathin membrane. results: nff of undiluted plasma resulted in a protein cake of~ μm on the membrane, which prevented further transport across the membrane and evs were buried in the formed cake that were impossible to identify. however, tfac as a modified version of tff, led to capturing cd positive evs on the pores of the membrane with little evidence of protein fouling. nsl allows us to fabricate nanopockets (bowls with a single pore at the base) with various diameter, depth and pore diameter. using nsl, we further utilize nanopocket membranes to purify ev samples in tfac devices. this nanomanufacturing technology will allow us to pattern nanopockets with various diameter, depth and pore diameter which increases the efficiency of capturing of evs. furthermore, nanopockets can be modified and coated by specific ev markers to capture different subpopulation of evs based on size and affinity and further allows identifying the phenotypic subsets of evs by combining both size and affinity-based techniques. summary/conclusion: we have developed a method for the capture and release of nanoparticles such as evs called tfac using ultrathin nanomembranes. nsl technology can be applied to fabricate nanopockets with different physical and biochemical properties. utilizing nanopocket membranes in tfac system will allow us to separate different subpopulations of evs based on size and affinity. funding: this project was supported in part by the national science foundation (iip ) to j.l.m and t.r.g., department of defence (ca ) to j. l.m., and the national institutes of health (r gm ) to t.r.g. the addition of a size exclusion chromatography step to various urinary extracellular vesicle concentrating methods reveals differences in the small rna profile introduction: urinary extracellular vesicles (evs) and their rna cargo are a novel source of biomarkers for various diseases, however non-vesicular rna (e.g. associated with proteins) is also present within urine. this study aimed to identify the optimal method for isolating and enriching evs from human urine prior to small rna analysis. methods: three ev concentration methods, ultracentrifugation (uc); a precipitation-based kit (pk); and ultrafiltration (uf), were compared using ml aliquots of pooled healthy volunteer urine. evs were then separated from protein contaminants by size-exclusion chromatography (sec). presence of evs was confirmed by transmission electron microscopy and western blotting, and evs were quantified using nanoparticle tracking analysis (nta). small rna content of concentrated urine and fractions obtained by sec (evs and proteins) were evaluated with the agilent bioanalyzer small rna chip. results: ev recovery following sec of concentrated samples was - %, however particle: protein ratio (indicating ev purity) was approximately x greater after sec, regardless of the concentrating method used. uf+sec yielded the highest number of evs (per ml of urine) compared with pk+sec and uc+sec. small rna analysis from uf-concentrated urine (prior to sec treatment) identified peaks at nucleotides (nt) and nt. following sec, rna analysis indicated that ev fractions contained mostly small rna of~ nt, whereas the protein factions contained small rna of nt in size (consistent with mirnas). summary/conclusion: uf+sec provided the best balance between ev recovery (per ml urine) and particle: protein ratio. these data indicate that most of the nt sized rnas, presumably mirnas, are not within evs in urine. ev preparations obtained after uc, pk and sec (regardless of concentrating method) contain pre-dominantly~ nt sized small rna. these data outline the importance of removing non-vesicular proteins and rna from urine ev preparations prior to small rna analysis. funding: this research has been funded by petplan charitable trust. the use of rev for the optimization of ev separation and characterization by af introduction: the reproducibility of extracellular vesicle (ev) research has been hampered by the infinite number of separation and measurement techniques and the lack of appropriate reference materials (van deun et al., nat methods, ) . recombinant extracellular vesicles (rev) were developed as a biological reference material to overcome these limitations (geeurickx et al. nat comm ) . since rev have ev-like physical an biochemical characteristics and as they are trackable and distinguishable from sample ev they can be used as a spike-in material for data normalization and method development, and as a quality control. we used rev to optimize ev separation by asymmetrical flow field-flow fractionation (af ). methods: an af long channel column with a frit inlet driven by the eclipse system (wyatt) was coupled to a uv detector (shimadzu), mals dawn helios-ii (wyatt) and fluorescent detector (agilent). a spacer of µm and a regenerated cellulose membrane of kda were used. pbs supplemented with . % nan was used as a running buffer. light scatter profiles and uv profiles were analysed as well as the fluorescent emission spectrum as the rev are gfp positive. fractions were collected and analysed by nanoparticle tracking analysis (nta) and western blot. we also estimated the repeatability and reproducibility of the af technique by light scatter and fluorescence profiles as well as the recovery efficiency by nta. results: in a first step * ^ rev isolated from conditioned medium by a velocity gradient were injected in the af system to optimize the ev characterization protocol. later concentrated conditioned medium was spiked with * ^ rev and injected in the af column to optimize ev separation from non-ev contaminants. the most optimal separation protocol was obtained by varying detector and cross-flow settings. this protocol shows elution of monodisperse particles at each time point and size distribution estimations by af correspond to size determination by nta and electron microscopy. summary/conclusion: we were able to optimize the af protocol for characterization of ev by af as well as for separation of ev from crude conditioned medium samples by using rev. we demonstrate that rev are suitable for method development and that af has high potential as an ev separation technique. comparative evaluation of ev isolation methods for ev subpopulation analysis in human urine, plasma and cell culture media liang dong, richard zieren, kengo horie, sarah amend and kenneth pienta the brady urological institute, johns hopkins university school of medicine, baltimore, usa introduction: extracellular vesicles (evs) are membrane-enclosed particles of variable sizes that are released by any cell types to the extracellular space and are identified in all body fluids. a shortcoming in ev research is the lack of standardized isolation protocol for various sample types, resulting in heterogeneous outcomes in downstream analyses. in this study, we compared the ev isolation purity and efficiency among ultracentrifugation (uc), precipitation, sizeexclusion chromatography (sec) and a microfluidic tangential flow filtration device (exodisc) in human plasma, urine and cell culture media (ccm). methods: all evs were isolated by different isolation methods and characterized per misev guidelines. single-particle interferometric reflectance imaging senor (sp-iris) with optional fluorescence and nanoflow (nfcm) were used for single particle analysis. results: in ccm, total particle yield of exodisc was about times higher than those of the rest three methods. size distribution differed per sample, but the ranges were comparable between the different isolation methods. the total protein amount of sec, precipitation and exodisc were similar which were - times higher than that of uc. uc had the highest particle-toprotein ratio followed by exodisc. precipitation and sec had low ratios. when loading ug of total protein for western blot, cd , cd , cd and flot could only be detected in uc and exodisc samples, but not precipitation or sec. sp-iris and nfcm demonstrated consistent purity findings. in urine, total particle yields of exodisc and sec were about times higher than those of the rest two methods. the total protein amount of precipitation was times higher than exodisc and sec, times higher than uc. sec had the highest particle-to-protein ratio followed by uc and exodisc. precipitation had low ratios. in plasma, total particle yields of exodisc and precipitation were times higher than those of the rest two methods. and so were the total protein amount. sec had the highest particle-to-protein ratio followed by uc. exodisc and precipitation had low ratios. western blot, sp-iris and nfcm demonstrated consistent purity findings in urine and plasma. to evaluate particle capture efficiency, we spiked a known number of density-gradient uc purified evs to each method and the recovery rate of uc, precipitation, exodisc and sec was . %, %, . % and %, respectively. summary/conclusion: the order of ev isolation purity in ccm is uc, exodisc, sec and precipitation. in urine it's sec, exodisc, uc and precipitation. and in plasma, this order is sec, uc, exodisc and precipitation. exodisc and sec have similar high isolation efficiency followed by precipitation. uc has low efficiency for ev capture. a capillary-channelled polymer (c-cp) fibre spin-down tip approach for the isolation and biomarker characterization of extracellular vesicles of ovarian cancer origin kaylan d. kelsey, rhonda r. powell, terri f. bruce and r. kenneth marcus clemson university, clemson, usa introduction: extracellular vesicle (evs) profiling has shown promise for disease detection through less invasive sampling (liquid biopsies). current diagnostic tools for ovarian cancer are invasive or only semiinformative. thus, use of evs could prove useful in early disease detection. demonstrated is a hydrophobic interaction chromatography (hic)-based capillarychannelled polymer (c-cp) fibre tip spin-down process for the isolation of ovarian cancer evs for use in diagnostics. methods: polyester c-cp fibre micropipette tips are employed in the isolation of evs from biological matrices including cell culture media, urine, and blood plasma in a spin-down solid-phase extraction (spe) approach. evs were isolated from standards of healthy urine origin and from skov cells (human ovary adenocarcinoma). the c-cp fibre isolation method (taking less than mins and μl sample volumes) preserves the morphology and functionality of evs as confirmed by sem, tem, and confocal fluorescence microscopy. results: the dynamic binding capacity of ev standards on a cm pet c-cp fibre tip was found to be~ e particles ( %). the release of evs was confirmed using dot blot analysis for cd , cd , and cd tetraspanin proteins. immobilized evs were subjected to immunolabeling to allow the positive identification of a profile of ovarian cancer biomarker proteins (her , cd , egfr, epcam, ca ). summary/conclusion: this new ev isolation method introduces a simple capture mode, allowing for direct immuno-characterization and imaging on the fibre surface. this offers a unique and cost-effective opportunity for clinical analyses related to early detection and diagnosis of ovarian cancers (and others). the longterm goal is the creation of a rapid ev isolation and biomarker detection platform. funding: support from the national science foundation, eppley foundation for scientific research, gibson foundation, prisma health system and itor biorepository are gratefully acknowledged. development and optimization of purification method of exosomes by tangential flow filtration and ion-exchange chromatography approach tek lamichhane, ali navaei, sandeep choudhary, yonatan levinson and senthil ramaswamy cell & gene therapy r&d, lonza inc, rockville, usa introduction: extracellular vesicles (evs) such as exosomes have significant therapeutic potential, however, translation of ev-based therapies has been slowed down because of the biomanufacturing challenges. the isolation of evs, especially exosomes, is inherently challenging due to their small size, and heterogeneity in the mixture. the current isolation methods either have low recovery rate, aggregation, damaging the structure, time consuming or co-precipitation of contaminants. specially, it is difficult to process larger sized samples by centrifugation-based or immunoaffinity based methods because of the time and cost associated with these methods. methods: to overcome these roadblocks, we developed and optimized alternative purification techniques to isolate evs with higher purity and yield by using tangential flow filtration (tff) coupled with ion-exchange chromatography. we used bioreactor platform to produce evs from serum-free medium using bm-msc and hek s cells. bm-mscs were cultured on stirred tank bioreactors using microcarriers which provide a high surface area to volume ratio for the optimal cell growth and evs production. impellers were used to enhance mixing and maintain homogeneous culture conditions that can be easily monitored and controlled. results: depth filtration was applied for clarification of conditioned medium. we screened different types of filters during depth filtration for the best recovery of evs. tff membranes with different pore sizes were used to optimize the purity and yield of evs. because of the negatively charged nature of evs, anion exchange chromatography was chosen to capture and separate tff purified vesicles by their surface charge characteristics. we compared monolith based and membrane-based anion exchange columns to remove contaminants and purify exosomal fractions. the purity, size and presence of exosomal markers in isolated evs at each step of purification was evaluated by f-nta, nano-fcm and tetraspanins based elisa kits. summary/conclusion: in summary, our optimized methods improved the speed of isolation and purity of evs to the clinical grade. the production and isolation methods of exosomes that we developed here will be easily expandable to support large-scale and cgmp compatible bio-manufacturing in the future. use of an alternating current electrokinetic microelectrode chip to positively identify oncology, neurology, and infectious disease samples through plasma extracellular vesicle analysis juan pablo hinestrosa, jean lewis, david searson, orlando perrera, alfred kinana, heath balcer and rajaram krishnan biological dynamics, inc., san diego, usa introduction: cancer, neurological, and infectious diseases are leading causes of death, with early detection needed to improve outcomes. extracellular vesicles (evs) in the blood contain disease biomarkers, but current methods do not allow rapid analysis, and are often limited to one biomarker type. methods: we developed methods using alternating current electrokinetics (ace) to isolate evs from bloodbased samples and analyse the evs in situ with downstream assays for protein and nucleic acid biomarkers. we investigated if we could identify tuberculosis (tb) donor samples, protein and nucleic acid biomarkers in evs derived from cancer cell lines, and alzheimer's disease (ad) protein biomarker levels. results: ev isolation was confirmed by positive identification of the proteins cd , cd , and cd and measurement of ev mrnas using a direct rt-ddpcr assay. different disease models were analysed following method development. tb was used as a model for infectious disease, with tb positive and tb negative samples isolated on ace chips and analysed for levels of lipoarabinomannan and ag . using a cut-off above the negatives, the auc of roc curves were . and . , respectively. for oncology, cancer cell lines were cultured and evs isolated from supernatants were spiked into human plasma for analysis. levels of pd-l or glypican- on evs were able to be measured following ace capture. additionally, dna and rna mutations known to be present in the cell lines were able to be detected using ngs and qrt-pcr, respectively. using ad samples as a neurological disease model, tau and phospho-tau t (p-tau t ) in human donor plasma were detected. in ad and healthy donor samples, p-tau t signal increased % in diseased versus healthy donors. summary/conclusion: ace chips are an innovative ev isolation and analysis platform that allow rapid disease sample detection in a wide range of studies with high sensitivity and specificity. introduction: colorectal cancer (crc) is one of the most frequent causes of cancer-related death. in the majority of crc patients, mutation in the apc gene is among the first genetic events. it leads to uncontrolled activation of the wnt pathway, and thus, to adenoma formation. some of these adenomas may then further progress to crc with the accumulation of other mutations. the d organoids maintain the cellular and genetic heterogeneity of in vivo tissues and haves proved to be so far the best ex vivo model of human cancers. here we analysed the ev-based communication between cancer cells and fibroblasts by i) identifying factors that substantially increase ev release from intestinal cancer cells and ii) by determining cargo components of evs that enhance tumour cell proliferation. methods: we used commercially available and patientderived fibroblasts and crc organoids. the medical research council of hungary approved all experiments with human samples and informed consent was obtained from patients. evs were studied by using antibody-coated beads, trps, nta, tem and western-blotting. we introduced apc mutation into wild type murine small intestinal organoids by crispr-cas . results: we found that in crc patient-derived organoid cultures, small evs were preferentially secreted. we observed that apc mutation and the accumulation of the extracellular matrix component collagen critically enhanced ev secretion in intestinal organoids. furthermore, we showed that amphiregulin, present on fibroblast-derived ev, contributed to the maintenance of the intestinal stem cell pool and to cell proliferation in epidermal growth factor-dependent crc organoids. summary/conclusion: by proving the key role of mutations, collagen deposition and ev-bound amphiregulin in the release intensity and functions of the evs, we identified novel mechanisms in the progression if crc. funding: this work was funded by otka-nn , by the national competitiveness and excellence program nvkp_ - (national research, development and innovation office, hungary) and by the national excellence program in higher education (ministry of human resources, hungary). prostate cancer-derived evs induce a pro-inflammatory phenotype in the stroma blandine f. victor a , dolores di vizio b , andrew chin c , tatyana vagner b , javier mariscal b , mandana zandian a , catherine grasso a , roberta gottlieb a and helen goodridge a a cedars-sinai medical center, los angeles, usa; b cedars-sinai medical center, west hollywood, usa; c cedars-sinai, los angeles, usa introduction: since % of patients with metastatic prostate cancer (pc) develop bone metastasis, identifying the mechanism that drives this process is essential. most ev research has been focused on the role of exosomes in mediating the pre-metastatic niche formation. however, most of these studies do not separate exosomes from large evs. our preliminary studies have demonstrated that a subclass of evs known as large oncosomes (lo) can reprogram prostate fibroblasts, at the primary tumour site, promoting angiogenesis and enhancing the migration and invasion of pc cells in vitro and tumour growth in vivo. the bone marrow is the initial site of entry into the bone microenvironment for disseminating tumour cells (dtcs) and is a rich source of nutrients that houses various cells types including bone marrow derived mesenchymal stem cells (bm-msc) and immune cells such as neutrophils, which have been implicated in metastasis. here we investigate the role of lo in reprogramming bm-mscs and driving bone metastasis in pc. methods: differential centrifugation, density gradient centrifugation, trps, rna sequencing, qpcr, migration assay, invasion assay, chemotaxis assay. results: we report that pc-derived evs induce distinct gene expressions changes in bm-mscs. rna-seq analysis identified inflammatory and immune regulating cytokines as top differentially expressed genes (deg) in bm-msc. moreover, lo induced a more potent response in bm-msc in comparison to exo and to non-treated controls. the genes enriched in lo treated bm-msc were associated with tumour cell motility. in agreement with the gene expression data, lo-treated bm-msc attracted migration and invasion of significantly more pc cells than exo -treated bm-mscs. in addition, the top deg expressed in ev treated bm-msc were identified as potent neutrophil chemoattractant proteins. in line with the rnaseq findings, the lotreated bm-msc demonstrated enhanced chemotaxis of neutrophils towards them in comparison with exo or vehicle-treated bm-msc. finally, we show that the observed differences in bm-msc's response to lo and exo may be mediated by distinct molecular pathways. summary/conclusion: the results from this study provide novel insight into how tumour derived evs alter the bone marrow microenvironment and how they may drive bone metastasis in prostate cancer. the αvβ integrin in cancer cell-derived small extracellular vesicles enhances angiogenesis introduction: prostate cancer (prca) cells crosstalk with the tumour microenvironment by releasing small extracellular vesicles (sevs). sevs isolated from prca cell media, express the epithelial-specific αvβ integrin, a surface receptor for fibronectin and vitronectin. the αvβ integrin is not detectable in healthy prostate tissues but is highly expressed in prca. in this study, we hypothesized that αvβ in cancer sevs plays a crucial role in angiogenesis. methods: the sevs isolated from prca cell media were characterized by nanoparticle tracking analysis, iodixanol density gradients and expression of sev markers. the αvβ -negative endothelial cells (hmec ) were incubated with αvβ -positive sevs from prca cells to evaluate the transfer of αvβ by immunoblotting (ib) and facs. the effect of αvβ -positive sevs on motility, tube formation and angiogenic signalling were assessed by boyden chamber, angiogenesis assays and ib in hmec . results: we demonstrate for the first time that the αvβ is de novo expressed on endothelial cell surface by sevmediated protein transfer. prca cell-derived αvβ -positive sevs, significantly promote the motility and the formation of nodes, junctions and tubules by hmec . mechanistically, we demonstrate that hmec treatment with sevs from pc cells that endogenously express αvβ , decreases pstat (y ), a negative regulator of angiogenesis, while upregulating survivin, an inducer of angiogenesis. hmec treatment with sevs isolated from pc cells harbouring crispr/cas -mediated downregulation of β , or shrna-mediated downregulation of β , results in increased levels of pstat (y ). this sev treatment also results in a decrease of survivin in sevs and hmec . summary/conclusion: overall, our findings show that αvβ in prostate cancer sevs regulates a novel proangiogenic signalling pathway. funding: this study was supported by nci r - (lrl); p - (lrl and dca). introduction: advanced prostate cancer (pca) is asso-introduction: extracellular vesicles (evs) are secreted from cells, and carry bioactive proteins and rna cargoes. increasing numbers of studies have identified key roles for exosomes in driving aggressive tumour behaviours, including metastasis. however, the detailed mechanisms and responsible factors in the ev cargo are still unclear. recently, immune system has been considered as an important factor in establishing and maintaining metastasis. our goal is to identify the role of head and neck squamous cell carcinoma (hnscc) derived small evs (sevs) in tumour metastasis from the study analysing the effects of sevs on metastasis and tumour immunity. methods: sevs were collected from the conditioned media of hnsccs and purified through cushioned density gradient ultracentrifugation. an orthotopic mouse model was used for the assessment of tumour angiogenesis and metastasis. moc (inflammationinducing rarely metastasizing murine hnscc line) and moc (highly metastasizing murine hnscc line) were used for this study. moc and moc cells were transplanted into mice tongues orthotopically, and moc /moc derived sevs or pbs were injected into the tumour twice in a week. two weeks after tumour transplantation, mice were sacrificed and tumours were sectioned for pathological analysis and facs analysis. in facs analysis, the number and species of tumour-infiltrated immune cells were measured. results: injection of sevs from moc into moc tumours suppressed frequency of lymph node metastasis. on the other hand, injection of sevs from moc into moc tumours didn't promote metastasis. cd positive t-cell distribution in moc tumour was significantly changed by moc sev injection. t-cell deprivation treatment using anti-cd antibody increased the frequency of metastasis in moc -sev treated moc tumours. from the result of proteomics analysis on moc and moc sevs, immune-regulated proteins and metastasis-suppressing proteins were observed in moc sevs. summary/conclusion: we find that low aggressive hnscc sevs affect metastasis of highly metastasized hnscc, and also find that changing immune cell distribution may be related to the result. this mechanism and finding contributes to understanding the possible role of hnscc sevs on metastasis as well as on the tumour immune microenvironment. funding: this work was supported by the nih under award numbers r ca and r ca to aw. desmoglein enhances squamous cell carcinoma tumour development through extracellular vesicles in an il- /mir- a-dependent mechanism introduction: the cadherin dsg is a stem cell marker that is upregulated in many different cancers, including sccs, and its expression correlates with poor prognosis. dsg activates mitogenic signalling and plays a key role in cell proliferation, migration, and survival. we recently showed that dsg enhances ev release, but the mechanism by which these evs modulate tumorigenesis is not fully understood. methods: we established scc cell lines stably expressing wildtype dsg or a palmitoylation deficient mutant, dsg cacs. evs were isolated by sequential ultracentrifugation, iodixanol gradient separation, or qev izon column, and analysed by nta and bca. tumour xenografts were established by subcutaneous injection of cells in scid mice and monitored up to weeks. cytokine profiling was determined by antibody array. mirna expression was analysed by rnaseq and confirmed by qpcr. results: dsg enhanced ev release by % and promoted a~fivefold increase in tumour size in xenograft models. tumour growth was increased when control cells were treated with a single µg dose of evs. loss of palmitoylation, which altered membrane trafficking of dsg , reduced ev release (~ %) as well as tumour development. plasma evs from xenograft mice reflected in vitro particle counts from scc cell lines. a cytokine array analysis was performed revealing that dsg -evs were enriched with pro-inflammatory cytokines including il- , a potent chemotactic and angiogenic factor. most importantly, il- was surface-bound on evs. furthermore, rnaseq revealed mir- a, a negative regulator of il- , to be significantly downregulated in response to dsg . treatment with mir- a mimic or mir- a inhibitor decreased or increased, il- expression in scc cells, respectively. summary/conclusion: in summary, dsg plays a key role in scc tumour development by increasing ev biogenesis and downregulating mir- a, which in turn upregulates il- synthesis and release which can promote invasion, angiogenesis and metastasis. funding: nih r introduction: stem-and progenitor cell transplantation therapy holds great promise for regenerating damaged heart tissue. several lines of evidence suggest that its efficacy is mainly caused by secreted extracellular vesicles (evs). indeed, cardiac progenitor cell (cpc)-derived evs have been shown to protect the myocardium against ischaemia/reperfusion injury in several preclinical models. however, the underlying mechanisms for cpc-ev-mediated cardioprotection remain elusive. here, we utilized the proteomic composition of cpc-evs released during different culture conditions, to unravel protein-mediated effects of cpc-evs on the endothelium. methods: cpcs were stimulated with calcium ionophore (ca ion-evs) or vehicle (control-evs) for hours and evs were isolated from serum-free conditioned medium using size exclusion chromatography. ev concentration and size was assessed using nta. evs were functionally characterized based on endothelial cell activation by western blotting and an endothelial cell scratch assay. the proteomic composition of both ev conditions was profiled using mass spectrometry. cpc-ev knockouts for specific proteins were generated using crispr/cas technology. results: we found enhanced phosphorylation of erk / and akt in endothelial cells and increased wound closure after stimulation with control-evs, but not after stimulation with ca ion-evs. proteomic analysis identified a total of ev-associated proteins, with proteins uniquely expressed in control-evs. another proteins were revealed as candidate proteins, based on their relative enrichment in control-evs compared with ca ion-evs. go analysis demonstrated that differentially expressed proteins were involved in vascular endothelial growth factor signalling, extracellular matrix organization and angiogenesis. to investigate the involvement of the individual candidate proteins on endothelial cell activation, knockout evs of multiple proteins were generated and functionally characterized. summary/conclusion: a specific set of ev proteins is identified that may be functionally responsible for the activation of endothelial cells upon exposure to cpc-evs. generating knockout evs for each of these proteins will help to investigate their individual roles. this may lead to a better mechanistic understanding of the use of cpc-evs as therapeutics for cardiac repair. funding: erc- -cog- evicare grant. hypoxia enhances the therapeutic potential of human cd + stem cell exosomes in ischaemic hindlimb repair ischaemic cardiovascular disease. we have previously shown that human cd + cell-derived exosomes (cd exo) improve perfusion and function of the ischaemic tissues. hypoxia is shown to modulate the secretion and content of exosomes in both cardiovascular and cancer research. therefore, we hypothesized that hypoxia can modulate the content and regenerative efficacy of human cd exo. methods: cd exo were isolated from primary human cd + stem cells cultured under hypoxia ( . % o , or normoxia ( % o , n-cd exo) using density gradient ultracentrifugation. cd exo size was measured using trps, nta, and dls and surface protein expression was determined using imaging flow cytometry. function of cd exo was assessed using cell viability, migration and matrigel tube formation assays in vitro and a mouse hind limb ischaemia model (hli) in vivo. protein content of hypoxic or normoxic cd exo was evaluated via lc-ms/ms and -d -dige followed by lc-ms/ms. results: we did not observe any significant differences in size or in quantity of exosomes secreted from h-or n-cd cells. both h-and n-cd exo expressed cd , cd and cd surface markers. interestingly, h-cd exo significantly improved cell viability, migration and tube formation of huvecs in vitro compared to n-cd exo. in the same line, h-cd exo also significantly improved perfusion (ratio: . ± . v . ± . ) and prevented ischaemic limb amputation ( % v . %) as compared to n-exo (p < . ; n = - ) in a murine (balbc nude) model of hind limb ischaemia. flow cytometry and confocal microscopy indicated that h-exo was uptaken by endothelial cells in the ischaemic limb. remarkably, we detected several proteins (including a fragment of hemopexin) and mirnas (mir- ) that could be responsible for the proangiogenic and beneficial function of h-cd exo. we have also demonstrated that removal of surface proteins diminished the pro-angiogenic function of cd exo. summary/conclusion: hypoxia enhanced the proangiogenic and regenerative potential of cd exo, and thus, may represent a more efficient clinical strategy for cd exo therapy. our research is clinically important to improve therapeutic angiogenesis in diabetic and cardiovascular patients with compromised stem cell populations. hyun-ji park a , jessica r. hoffman b and michael davis b a emory university, decatur, usa; b emory university, atlanta, usa introduction: exosomes, a subset of membrane nanovesicles, transfer cellular information by passing proteins and nucleic acids between cells. exosomes have been implicated as the mechanistic unit in stem cell therapy, as inhibition of exosome synthesis abrogates the effects of cell therapy following cardiac injury. more importantly, increasing evidence indicates that mirnas (mirs) within exosomes serve as important signalling molecules to regulate inflammation, recruit stem cells, and repair diseased tissue. among exosomal mirs, mir- and − are known to decrease angiogenesis, cell migration, and increase inflammation in various types of cells. here, we investigated the inhibition of these negative mirs as a means to improve the reparative capacity of c-kit+ progenitor cell (cpcs) exosomes. methods: cpcs were isolated from three paediatric patients using magnetic-bead sorting. ʹ-o-methylated rna duplexes inhibited mir- and − expressions in cpcs. exosomes (inhexos) were isolated from mirinhibited cpc conditioned medium. mir expression in exosomes and cpc was quantified by qrt-pcr. migration and proliferation of mesenchymal stem cells (mscs) were assessed two days post-exosome treatment. for inflammation analysis, thp cells with/without tnfα exposure were treated with exosomes and the expression of il- , − , and − was quantified by qrt-pcr. finally, the angiogenic potential of inhexos was tested by tube formation of cardiac endothelial cells. results: inhibitor treatment of cpcs decreased exosomal mir- and − expression. treatment with inhexos enhanced msc migration and proliferation compared with normal cpc exosome (norexo). moreover, inhexos showed promising results for immune regulation, as tnfα-induced inflammation was decreased in thp exposed to inhexos for h. however, tube formation capacity is slightly decreased (~ %) by inhexo compared to norexo. summary/conclusion: exosomes from mir- and − -depleted cpcs may be a promising strategy for the treatment of various cardiac diseases, as they enhanced stem cell recruitment and proliferation, and regulated inflammation and angiogenesis. while other studies focus on boosting the reparative potential of exosomes by increasing positive mir and mrna cargo, the inhibition of negative mir in exosomes could be an overlooked strategy for the treatment of cardiac disease. endo-lysosomes as an alternative intracellular location for ev cargo delivery with disease relevance introduction: extracellular vesicles (ev) are lipidbilayer nanovesicles that carry macromolecules and act as paracrine vectors for cell-to-cell communication. the processes regulating ev biogenesis are largely known, whereas how ev cargo is delivered to recipient cells remains poorly understood. a simple mechanism proposed is direct ev fusion with the cell membrane that liberate cargo into the cytosol. in this study, we observed that cargo release occurs also at an alternative intracellular location and that this acquires a disease relevance. methods: ev were isolated by serial centrifugation and characterized. for uptake studies, ev were traced by labelling donor cells with a lipophilic dye or by overexpressing gfp-cd . uptake was assessed by cytofluorimetry or by live confocal imaging. co-localization studies were performed with ectopic marker expression or by immune staining. protein-protein interaction was analysed by bi-molecular fluorescence complementation (bifc). prion-like transmission was studied using a pro-fibrillogenic tau fragment in donor cells and full-length tau in recipient cells. for quantification of subcellular localization, an automated algorithm based on machine learning was developed. lysosomal stress was monitored by nuclear translocation of tfe and lysotracker staining. antibodies directed against pathogenic epitopes of tau were employed to assess prionlike transmission. results: ev were taken up by recipient cells through an endocytic process and accumulated in endo-lysosomes (el). when cells were exposed to ev carrying a profibrillogenic tau, recipient cells accumulated tau within el by an autophagic process. direct interaction of ev-tau and cellular tau in el favoured the appearance of pathological epitopes. cells displaying this condition showed an increased el stress and cytotoxicity. summary/conclusion: in this study, for the first time we report that el represent a critical subcellular location where transcellular prion-like transmission mediated by ev of a neurodegeneration-associated protein occurs. thus, the degradative pathway most likely involved in the recycle of ev and endogenous proteins is highjacked in disease. these findings represent a novel mechanism for ev acting as vector for transcellular propagation of tau, which opens up new therapeutic interventions trying to halt the disease. funding: supported by gelu foundation. anti-human fab fragment of cd antibody prevents the endocytosis of melanoma and colon cancer-derived extracellular membrane vesicles and nuclear transfer of their cargos introduction: interfering with the mechanisms regulating intercellular communication mediated by extracellular membrane vesicles (evs) may find relevance especially in oncology where cancer cell-derived evs have an implication in the malignant transformation of tumour microenvironment. our laboratories recently demonstrated a novel intracellular pathway in which a fraction of endocytosed ev-associated proteins is transported into the nucleoplasm of the host cell via a subpopulation of rab + late endosomes entering into the nucleoplasmic reticulum. here, we have investigated the effect of a monovalent fab antibody against the tetraspanin cd (referred hereafter as cd fab), on the internalization of evs and nuclear transfer of their cargo proteins. chair: david r f. carter -oxford brookes university chair: neta regev-rudzi -weizmann institute of science methods: to monitor the intracellular transport of ev-associated proteins, we used bioengineered fluorescent evs containing cd -gfp fusion protein from femx-i melanoma, sw colorectal cancer and bone marrow-derived mesenchymal stromal cells (msc) as donors and the same cell types as recipients. evs were enriched by differential centrifugation from h serum-free conditioned media and characterized by zetaview nanoparticle tracking analysis, zetapotential and immunoblotting. cd fab was prepared from h hybridoma cells using the pierce fab purification kit. results: we previously demonstrated that silencing cd both in evs and recipient cells strongly decreased the endocytosis of evs and abolished the nuclear transfer of their cargos. here we show that cd fab significantly reduced the cellular uptake of cd -gfp+ evs and the nuclear transfer of their proteins in melanoma, colorectal cancer and msc used as receptor cells in a dose-dependent manner. the effect on the nuclear transfer is probably a direct consequence of the endocytosis inhibition of evs. in contrast, the divalent, intact cd antibody stimulated both events. summary/conclusion: the effect of cd fab appears independent of the used ev-donor cell types or receptor cells, probably due to the widespread expression of cd both at plasma membrane and ev surface. in conclusion, by impeding intercellular communication in the tumour microenvironment, cd fab-mediated inhibition of ev uptake, combined with direct targeting of cancerous cells could lead to the development of novel anti-cancer therapeutic strategies. a bright, versatile reporter for multivesicular body trafficking and exosome secretion and uptake bong hwan sung, ariana von lersner, jorje guerrero, evan krystofiak, david inmann, roxanne pelletier, andries zijlstra, suzanne ponik and alissa weaver vanderbilt university, nashville, usa introduction: live imaging of exosomes is one of the required tools to understand the function of exosomes. our previous live-cell reporter, phluorin-cd allows dynamic subcellular monitoring of exosome secretion in migrating and spreading cells. however, there were some caveats to its use, including dim fluorescence and the inability to make cell lines that stably express the protein. methods: a stabilizing mutation, m r is incorporated in the phluorin moiety and now exhibits stable expression in cells and superior monitoring of exosome secretion. a dual-tag reporter was created by incorporating a further ph-insensitive red fluorescent protein, mscarlet to the c-terminus of phluo_m r-cd . cancer cells stably expressing the constructs were imaged using a variety of microscopy techniques in vitro as well as in vivo. purified small evs labelled with phuo_m r-cd were imaged using immunogold transmission electron microscopy (tem) and quantitated for the half-life in the blood circulation using flow cytometry. results: phluo_m r-cd and phluo_m r-cd -mscarlet are exclusively detected in exosomeenrich small ev preparations. immunogold tem visualizes the phluo_m r tag is located on the surface of small evs. live cell imaging reveals phluo_m r-cd -positive puncta left behind migrating cells suggesting the deposition consists of exosomes. those puncta and trails are not only positive for exosome markers such as cd , alix, and tsg but also correspond to small evs observed by a scanning electron microscopy. the dual-tag reporter allows visualization of the exosome lifecycle, including multivesicular body (mvb) trafficking, mvb fusion, exosome uptake and endosome acidification. summary/conclusion: using phluo_m r-cd construct, we demonstrate superior visualization of exosome secretion in multiple contexts and a role of exosomes in promoting leader-follower behaviour in collective migration by observing that exosomes are secreted at the front of migrating cells and left behind in exosome trails. the dual-tag reporter allows visualization of the entire exosome lifecycle. we anticipate that these reporters will be broadly useful to investigate regulation and functions of exosome secretion and uptake in diverse physiological conditions. funding: r gm , r ca , u ca - s , r ca . uncovering novel genes regulating ev-mediated functional rna transfer using a crispr/cas -based reporter system introduction: extracellular vesicles (evs) play a pivotal role in intercellular communication through functional transfer of bioactive cargo, including rna molecules. despite increasing interest in ev-mediated rna transfer, our understanding of the pathways and mechanisms regulating ev-mediated rna delivery and processing is limited due to a lack of suitable readout systems. we recently developed a novel crispr/cas -based reporter system that allows study of ev-mediated rna transfer at single-cell resolution. here, we further validate this system by studying the role of known targets involved in ev uptake and intracellular membrane trafficking, and subsequently employ this system to uncover various novel genes that play a regulatory role in functional rna transfer. methods: we employed a novel crispr/cas -based stoplight reporter system, in which egfp expression is activated upon functional delivery of targeting single guide rnas (sgrnas) stably expressed by donor cells. intercellular functional rna transfer was assessed by measuring egfp expression in acceptor cells using fluorescence microscopy and flow cytometry after direct co-culture, transwell co-culture, and upon addition of isolated evs. potential roles of various genes in intercellular rna transfer were assessed by rnaimediated target knockdown in acceptor cells, prior to co-culture experiments. rnai knockdown was confirmed by qpcr analysis. results: a significant activation of egfp expression was observed in acceptor cells after direct co-culture and transwell co-culture with donor cells expressing sgrnas, as well as after addition of evs from cells expressing sgrnas. reporter activation was substantially decreased after knockdown of multiple targets involved in ev uptake through endocytosis and/or intracellular membrane trafficking. based on these results, a potential role of various novel genes in intercellular rna transfer was studied in acceptor cells. these experiments uncovered various novel targets involved in ecm binding, endocytosis, intracellular membrane trafficking, as well as various rho gtpase interactors. summary/conclusion: we previously demonstrated a crispr/cas -based reporter system that allows the study of functional delivery of small non-coding rnas with single-cell resolution. here, we show that this novel approach allows the study of specific genetic targets and pathways in ev-mediated functional rna delivery, and unravel the regulatory pathways that dictate the underlying processes. quantitative characterization of extracellular vesicle uptake and content delivery within mammalians cells gregory lavieu a , emeline bonsergent b , eleonora grisard c and clotilde théry d introduction: extracellular vesicles (evs), including exosomes, are thought to mediate intercellular communication through the transfer of biomolecules from donor to acceptor cells. occurrence of ev-content delivery within acceptor cells has not been unambiguously demonstrated, let alone quantified, and remains debated. methods: we developed a cell-based assay in which evs containing luciferase-tagged cytosolic cargo are loaded on unlabelled acceptor cells. measurement of luciferase activity associated with acceptor cells revealed ev uptake efficacy. additional cell fractionation procedure that separates membranes from cytosol revealed the occurrence of ev-content release within the cytosol of acceptor cells. results: results from dose-responses, kinetics, and temperature-block experiments suggest that ev-uptake is limited ( % spontaneous rate at h), does not depend on bona-fide ev-receptor, at least for the tested acceptor hela cells. yet, further characterization of this limited ev-uptake, through cell fractionation that separates membranes from cytosol, revealed the occurrence of ev-content release within the cytosol of acceptor cells. cytosolic release is inhibited by bafilomycin-a and overexpression of ifitm proteins, which prevent virus content delivery. summary/conclusion: our results show that ev-content release requires endosomal acidification and suggest the involvement of membrane fusion. funding: anr -ce - - and arc pja and pga rf . introduction: glioblastoma is a highly malignant brain tumour with a poor prognosis. its ability to develop therapeutic resistance result in devastating clinical outcomes. to solve the intractable problem, we need highly sensitive diagnostics that can detect the molecular changes during treatments. extracellular vesicles (evs) can be a potential biomarker to monitor treatments and the host cell ev mapping can better reflect molecular changes in the tumour immune microenvironment. we have developed a droplet-based single ev protein sequencing platform that overcomes limitations of current bulk measurement technologies, which make it difficult to discover a rare ev population in the presence of high background. methods: we multiplex protein measurements to profile hundreds of proteins at a time by using an antibody-dna conjugate and sequencing. we barcode each ev in droplets and make amplicons that are comprised of both ev barcodes and antibody barcodes for sequencing. barcoded antibodies are made using tco-tetrazine click reaction and evs are labelled with these barcoded antibodies. the labelled evs are encapsulated into droplets with barcoded beads that serve as a template for ev barcodes. we then perform extension to make amplicons that contain both ev barcodes and antibody barcodes for sequencing. results: we successfully fabricated barcoded beads using a split-pool approach and validated by observing a fluorescence decrease of the sybr green after dna strand denaturation. we used a -channel droplet maker to encapsulate barcoded beads, single ev, and master mix into droplets. close packing of barcoded beads allowed > % encapsulation into droplets. both droplet and tube-based methods achieved a similar high amplification efficiency (ct < for evs). we confirmed the amplicon size by running a gel, which showed the right amplicon size (~ bp) from the droplet and tube prepared samples and no signal from the negative control. summary/conclusion: the droplet-based single ev profiling platform has the ability to identify rare immune ev subtypes in the peripheral blood, which would otherwise be impossible to detect due to the copresence of abundant normal evs. this cutting-edge technique has the potential to revolutionize treatment monitoring of high-cost immunotherapies, avoid unnecessary toxicities, and enhance personalized medicine capabilities. funding: schmidt science fellows, in partnership with the rhodes trust po ca , ro ca , r ca quantbio graduate student award at harvard university. introduction: in this study, we compared four orthogonal technologies for sizing, counting, and phenotyping of evs. the platforms were: single-particle interferometric reflectance imaging senor (sp-iris) with optional fluorescence, nanofcm nanoflow (nf), nanoparticle tracking analysis (nta) with fluorescence, and microfluidic resistive pulse sensing (mrps) . results from these platforms were compared with results from standard ev characterization techniques such as transmission electron microscopy (tem) and western blot (wb). methods: human t lymphocyte h (high cd , low cd ) and promonocytic u (low cd , high cd ) cells were chosen for their distinct tetraspanin profiles without abnormalities that might result from genetic manipulation. evs were isolated from culture conditioned medium (ccm) by differential ultracentrifugation (duc) and size exclusion chromatography (sec) and characterized per misev guidelines. synthetic particles (silica and polystyrene spheres) with known concentrations and mixed size distributions were also tested. results: particle counts from nf and mrps were consistent, while nta detected approximately one order of magnitude lower for ccm derived evs, but not for synthetic particles. sp-iris events could not be used to estimate particle concentrations. for sizing, nf, mrps, and sp-iris returned similar size profiles, with smaller sizes predominating (per power law distribution), but with sensitivity typically dropping off below diameters of nm. nta detected a population of particles with a mode diameter above nm. additionally, sp-iris, nf, and mrps were able to identify at least three of four distinct size populations in a mixture of silica or polystyrene nanoparticles. finally, for tetraspanin phenotyping, the sp-iris platform in fluorescence mode and nf were able to detect at least two markers on the same particle. summary/conclusion: based on the results of the study, we can draw conclusions about existing singleparticle analysis capabilities that may be useful for ev biomarker development and mechanistic studies. funding: this project is funded by mh and ug ca . importance to ev organotropism. yet, most techniques rely on bulk characterization, or are severely restricted by the diffraction limit. the exoview r (nanoview biosciences) combines interferometry, immunocapture, and immunofluorescence, introduced as an alternative technique to multiplex protein detection on single evs below the limit of diffraction. here, we use this technique to characterize tetraspanin multiplexing on evs and to identify spatial patterning of tetraspanins using steric hindrance of antibodies (abs). methods: evs were isolated from conditioned media from skov- cell culture or human serum. evs were incubated overnight on chips to allow immunocapture by anti-cd , anti-cd , or anti-cd . chips were then incubated with three fluorescent abs against the same epitopes and imaged on the exoview r . following concentration optimization, evs were tested after preincubating with carboxy-fluorescein diacetate succinimidyl ester (cfse) or fluorescent abs against tetraspanins. results: using different concentrations of evs, binding curves could be fit to characterize binding kinetics of abs. maximum concentration of evs could be identified that minimized fluorescent overlap. bright-field interferometry (detection limit~ nm) distinguished x fewer bound evs than fluorescent detection, while pre-labelling evs with cfse produced x more detectable evs than immunofluorescence. interestingly, evs captured by one tetraspanin did not necessarily show high fluorescent detection of the same tetraspanin. upon pre-incubating evs with a single ab, vastly different expression profiles were identified, indicating significant steric hindrance between abs. furthermore, pre-incubating evs with anti-cd ab significantly decreased detection of cd with less impact on cd . this discrepancy indicated possible spatial patterning of tetraspanins with cd and cd closely colocalizing on the ev surface. summary/conclusion: this combination of interferometry, immunocapture, and immunofluorescence produces unique information about size distribution of evs and single ev protein profile. this data corroborates that evs have distinct subpopulations of tetraspanins and indicates that tetraspanins may be spatially patterned. regulation of liver homoeostasis, regeneration and diseases by mesenchymal stem cell-derived apoptotic extracellular vesicles university of pennsylvania, philadelphia, usa introduction: billions of cells undergo apoptosis and produce apoptotic extracellular vesicles (apopevs) each day, whereas the roles of apopevs in regulating the organismal health and disease remain poorly understood. mesenchymal stem cells (mscs) emerge as critical contributors to tissue homoeostasis, while mscs suffer from apoptosis in regenerative transplantation. in this study, we investigated the function and mechanisms of msc-derived apopevs in regulating the organismal homoeostasis. methods: fas mutant (fasmut) and caspase knockout (casp -/-) mice were applied for apoptotic and apopev deficiency. mouse bone marrow mscs were cultured and apoptosis was induced by staurosporine (sts). msc-derived apopevs were collected by serial centrifuges and were infused into mouse circulation via caudal vein. tracing of apopevs were performed by radioisotope or fluorescent labelling. liver homoeostasis was evaluated at the histological and functional aspects. liver regeneration was induced by partial hepatectomy (phx). acetaminophen (apap) was used to establish acute liver drug injury. high-fat diet (hfd) was used to establish type diabetes (t d) and non-alcoholic fatty liver disease (nafld). results: after systemic injection, msc-derived apopevs migrate to liver and can be uptaken by liver macrophages and hepatocytes. fasmut and casp -/mice develop hepatomegaly with structural disorders, which particularly reveals hepatocyte polyploidization. furthermore, fasmut and casp -/-mice demonstrate liver glucose and lipid metabolic disorders. importantly, msc-derived apopev infusion significantly rescues structural and metabolic dysfunction in fasmut and casp -/-mice. mechanistically, apopevs use the soluble n-ethylmaleimide-sensitive fusion protein attachment protein receptor (snare) protein for interactions with recipient organelles thus transferring signalling molecules. moreover, msc-derived apopev infusion promotes liver regeneration after phx, prevents apap-induced liver injury, and ameliorates nafld in t d. summary/conclusion: msc-derived apopevs serve as crucial regulators of liver homoeostasis, regeneration and diseases. these findings indicate potential significant roles of apopevs in maintaining the organismal health and in developing therapeutics for diseases. (msc-sevs) mediate osteochondral regeneration in rats. however, the therapeutic effects of these msc-sevs/exosomes in restoring the mechanical competence of the repaired cartilage for joint function in a clinically relevant animal model remain to be addressed. to investigate this, we compared the structural and mechanical properties of the repaired cartilage in a rabbit model after intraarticular administration of msc-sevs and hyaluronic acid (ha) with that of ha alone, which is widely used as visco-supplementation. methods: bilateral osteochondral defects were surgically created on rabbits. immediately after surgery and at days and post-surgery, rabbits received ml injections of µg msc-sevs and ha in both knees, and rabbits received -ml injections of ha in both knees. at and weeks, macroscopic evaluation, histological scoring and compressive testing at different points on the repaired cartilage were performed. results: defects treated with msc-sev/ha showed improvements with time in macroscopic and histological scores and mechanical properties than defects treated with ha alone. in contrast, ha treated defects showed some repair at weeks, but this was not sustained, as evidenced by significant deterioration of histological scores and a plateau in mechanical properties from to weeks. by weeks, the msc-sev/ha repaired tissues demonstrated significantly better macroscopic score ( . vs . ; p < . ) and histological score ( . vs . ; p < . ). mechanical strength as measured by the young's modulus was significantly higher in the msc-sev/ha repaired cartilage than that in ha repaired tissues [defect centre ( . vs . mpa; p = . ) and overall periphery ( . vs . mpa; p = . ], and approximated that of the adjacent native cartilage. summary/conclusion: our findings demonstrated that msc-sevs and ha not only improved tissue morphology of the repaired cartilage but also promoted functional mechanical competence. this study establishes a clinically translatable protocol for use of msc-sevs for cartilage repair. introduction: mesenchymal stromal/stem cell (msc)exosome (mex) treatment has shown considerable promise in experimental models of bronchopulmonary dysplasia (bpd) and pulmonary hypertension (ph). mechanisms by which mex afford their beneficial effects remain incompletely understood and here, we embark into investigating them through assessment of mex biodistribution and impact on immune cell heterogeneity. methods: newborn fvb mice were exposed to hyperoxia (hyrx, % o ) at birth and returned to room air at postnatal day (pn) . mice received a bolus mex dose at pn . adoptive transfer studies were used to determine the role of mex-educated myeloid cells in vivo. mice were harvested at pn , , , or to characterize mex biodistribution and for assessment of pulmonary parameters. results: mex therapy effectively ameliorated core features of hyrx-induced neonatal lung injury, improving alveolar simplification, pulmonary fibrosis, vascular remodelling and blood vessel loss. exercise capacity testing and assessment of ph showed functional improvements following mex therapy. biodistribution studies demonstrated that mex localize in the lung, where they interact with lung monocytes/macrophages. whole lung mass cytometry (cytof) revealed that mex treatment promotes a pro-homoeostatic shift in lung immune cell apportion, replenishing the early hyrx-induced depletion in pulmonary cd + immune cells, restoring alveolar monocyte and macrophage populations and suppressing cellular inflammation. ex vivo and in vivo analysis showed that mex promotes a "pro-resolving" ccr -monocyte phenotype. notably, adoptive transfer of mex-educated bone marrow-derived myeloid cells (bmdmy), but not naïve bmdmy, restored alveolar architecture, blunted fibrosis, improved vascular remodelling and pulmonary blood vessel loss. summary/conclusion: mex treatment ameliorates core features of experimental bpd, restoring lung architecture, decreasing pulmonary fibrosis and vascular muscularization, ameliorating ph and improving exercise capacity. the beneficial actions of mex are associated with modulation of immune cell phenotypes, arising from mex-monocyte interaction. furthermore, adoptive transfer of mex-educated bmdmy rescued, at least in part, alveolar architecture, reduce fibrosis, improve vascular remodelling and pulmonary blood vessel loss. funding: this work was supported in part by an american thoracic society foundation grant (grw); the little giraffe foundation (grw); charles h. hood foundation major grants initiative (sk), nih r hl (sk) and united therapeutics research grant (sk and sam). immunomodulatory small extracellular vesicles derived from mesenchymal stem cells: a potential cell-free therapy for acute and chronic pulmonary vascular diseases introduction: vascular inflammation plays a critical role in acute respiratory distress syndrome (ards) and pulmonary arterial hypertension (pah). despite decades of research, there is no curative therapy for either condition. mesenchymal stem cells (mscs) have shown preclinical efficacy, mediated by release of extracellular vesicles. hence, msc-derived small extracellular vesicles (sevs) can harness the benefits of mscs with advantages in cost and safety. this study aims to evaluate the immunomodulatory effects of sevs in preclinical ards and pah. methods: msc-sevs were characterized by nanoparticle tracking analysis, electron microscopy and western blot. live fluorescence imaging measured in vitro and in vivo distribution of sevs. using a lipopolysaccharide (lps)-induced mouse model of acute lung injury (ali), a time course study of inflammatory response guided endpoint analyses. cell count and cytokines were measured in bronchoalveolar lavage fluid (balf) and histological lung injury was assessed. in ali mice, saline, mscs, msc conditioned media or sevs were administered . h post-lps. using a monocrotaline (mct)-induced rat model of pah, animals received saline or sevs at day . haemodynamic changes and right ventricular hypertrophy were evaluated at weeks. results: msc-sevs were nm in size with cd / expression. pkh -labelled sevs were taken up by endothelial cells. in the ali time course study, cell count and il b in balf peaked at h post-lps, whereas il peaked at h. histology showed significant intra-alveolar cell infiltrate at h. msc conditioned media attenuated il b in balf, whereas a trend towards reductions in il b and cell count were seen from delivery of mscs and sevs. using fluorescence imaging, lung accumulation of dir-labelled sevs was highest when administered h post-lps as compared to h, h or h. for pah rats, sevs reduced right ventricular systolic pressure ( . ± . mmhg) as compared to control ( . ± . mmhg; p = . ), whereas no changes were observed for right ventricular remodelling. summary/conclusion: these findings demonstrate the potential of msc-sevs to be used as a cell-free immunomodulatory therapy for acute and chronic lung vascular diseases. additional live and ex-vivo biodistribution studies will determine optimal timing of sev administration, tissue distribution and clearance in both ali and pah. changes in extracellular vesicle protein cargo after pro-inflammatory priming of umbilical cord mesenchymal stem cells (ucmscs) have been shown to suppress inflammatory responses in studies of autoimmune diseases. these therapeutic effects can be attributed to paracrine signalling, by which extracellular vesicles (evs) are one of the essential components. this study looks at how the culture conditions of ucmscs affects the type of evs they secrete. it also aims to identify an ev population with an anti-inflammatory potential for the treatment of autoimmune diseases. methods: ucmscs were isolated and culture expanded in a quantum® cell expansion system, then grown at %o , %o and primed with a pro-inflammatory cocktail. evs were isolated from ucmsc conditioned media by differential ultracentrifugation using a sucrose cushion and characterised by transmission electron microscopy and nanoparticle tracking analysis. ev markers were analysed using a europium-based immunoassay, macsplex exosome detection kit and immunoblotting. a proximity-based extension assay was used to identify inflammatory proteins in the evs. results: there was no difference in evs cultured at %o , %o or with pro-inflammatory conditions when analysed for size and morphology. all evs displayed the tetraspanin markers (cd / / ) and internal proteins (alix, hsp ). evs from primed cells showed a > twofold increase of cc chemokines and a > sixfold increase in cxcl and csf- . protein cargo did not differ in evs from %o and %o . summary/conclusion: this study showed that proinflammatory culture conditions alter ev protein cargo, evidenced by the increased production of chemotactic and angiogenesis associated proteins. upcoming rnaseq analysis will show if ucmsc culture conditions also affect mirna expression in evs. ongoing functional studies will determine how changes in ev cargo correlates with changes in t-cell proliferation and polarisation. funding: this work is fund by the orthopaedic institute ltd, keele university and the rjah orthopaedic hospital charity. alzheimer's disease biomarkers in plasma extracellular vesicles of neuronal origin correlate with brain pathology in mice introduction: multiple studies have shown that neuronal-derived extracellular vesicles (ndes) in blood contain alzheimer's disease (ad) biomarkers, especially tau. however, the convergent validity of tau in blood ndes in relation to brain pathology is yet to be determined. to address this, we measured total and phosphorylated tau levels in matched nde and brain tissue samples from ad mouse models. methods: we collected the cortex, hippocampus and plasma of xtg-ad, xtg-ad, and wild type (total of mice; female, male; age: mean = . , sd = . , - months) . plasma samples were collected retro-orbitally for weeks and at euthanasia via heart puncture. ndes from the pooled serial blood collections (nde ) and the single endpoint (nde ) were immunocaptured by targeting the neuronal marker l cam. we measured human total tau and pthr -tau (p-tau) in ndes and cortex and hippocampus homogenates using a luminex multiarray. results: overall, there were strong positive correlations for both total tau and p-tau between ndes and brain tissues across mice types. total tau in ndes showed positive correlations with levels in the cortex and hippocampus (r = . and . , p < . , cortex vs nde and nde ; r = . , p = . , hippocampus vs nde ; r = . , p = . , hippocampus vs nde ). levels of p-tau in nde showed positive correlations with levels in the cortex (r = . , p = . ) and hippocampus (r = . , p = . ); however correlations were not observed for nde (r = . , p = . vs cortex; r = . , p = . vs hippocampus). summary/conclusion: tau levels in circulating ndes reflect levels in cortex and hippocampus across ad model mice, supporting their convergent validity as "liquid biopsy" biomarkers for ad. funding: this research was supported in part by the intramural research program of the national institute on ageing, national institutes of health. exosomal ceramide mediates neurotoxicity of amyloid beta (aβ) in alzheimer's disease. ahmed elsherbini a , simone crivelli b , alexander kirov c , michael dinkins d , zhihui zhu a , haiyan qin a , sanjib karki a , priyanka tripathi a and erhard bieberich a a university of kentucky, lexington, usa; b university of kentucky, lexington, usa; c augusta university, augusta, usa; d augusta university, augusta, usa introduction: amyloid beta is a pathologic hallmark of alzheimer's disease (ad), however, the mechanism of aβ neurotoxicity is not fully understood. it has been reported that exosomes associate with aβ, but it is not clear how this association affects aβ neurotoxicity. methods: here we utilized several techniques to isolate exosomes from the sera of wild type (wt) and ad transgenic mouse model. ( xfad) as well as alzheimer's patients and healthy controls. we used exoquick, exoeasy, sequential ultracentrifugation, and size exclusion chromatography. particles' size and number were characterized by nanoparticle tracking analysis (zetaview). results: we report that the sphingolipid ceramide mediates neurotoxicity of aβ. we show that sera from ad transgenic mouse model ( xfad) and ad patients, but not the wt or healthy controls, contain a subpopulation of astrocyte-derived exosomes that are enriched with ceramide and are prone to aggregation (termed astrosomes) as confirmed by nanoparticle tracking and cluster analyses. when taken up by introduction: multiple sclerosis is the most common chronic inflammatory demyelinating disease of the central nervous system, affecting more than million people worldwide. ms is a multifactorial, immunemediated disease caused by complex genetic and environmental interactions. in recent years, extracellular vesicles (evs) have been described as powerful mediators of the modulation of biological processes (e.g. inflammatory and immune response) following environmental exposures such as particulate matter (pm), and have been described altered in ms. we characterized evs in patients with ms and healthy subjects matched for age and gender and evaluated the effects of pm exposure on ev release patients with ms compared with controls. methods: evs isolated from blood samples were characterized by nanotracking analysis and by flow cytometry after labelling with the following markers: cd + (monocyte), cd + (platelet), cd + (neutrophil), cd + (t-reg), and cd + (endothelium). pm and pm . concentrations at the residency of each subject were obtained from the regional air quality monitoring network. results: we observed decreased concentrations of cd + (p < . ), cd + (p < . ), cd + (p < . ), cd + (p < . ), and cd + (p < . ) in patients compared with controls. in cases, pm was inversely associated with cd + evs (pm . , β = − . ; p < . ), cd + evs (pm . β = − . ; p < . ), and cd + evs (pm β = − . ; p < . ; pm . , β = − . ; p < . ). on the contrary, in controls pm was positively associated with cd + evs (pm β = . ; p < . ; pm . , β = . ; p < . ). summary/conclusion: our findings showed a different composition of blood-derived ev subpopulations in patients compared with controls. moreover, we observed that patients and controls react differently to pm exposure in terms of blood-derived ev release, suggesting the involvement of this mechanism in the modulation of both inflammatory and immune responses, and thus in ms pathogenesis. plasma neuronal and astrocyte-derived exosomes serve as biomarkers of neurodegeneration and systemic bioenergetic effects in male cynomolgus monkeys self-administrating oxycodone ashish kumar a , yixin su a , david soto-pantoja a , jingyun lee a , ravi singh a , cristina furdui a , michael nader b and gagan deep a a wake forest baptist medical center, winston-salem, usa; b wake forest baptist medical center, winston-salem, usa introduction: opioid use disorder (oud) is currently a health emergency in the usa affecting millions of people. oud is a complex issue requiring a multipronged strategy. at the biological level, there is an urgent need to understand the dynamic molecular changes and adverse effects associated with opioid addiction. here, we aimed at identifying the biosignature of brain cells-derived exosomes associated with opioid addiction in a non-human primate (nhp) model of oud in which cynomolgus monkeys perform cognitive tasks and self-administer (sa) intravenous oxycodone daily. we also characterized the systemic adverse effects of the brain cells-derived exosomes from drug-naïve and oxycodone sa monkeys. methods: we isolated total exosomes (te) by ultracentrifugation and exoquick methods from the plasma of male monkeys self-administrating oxycodone for years and naive monkeys. subsequently, from the te population, we isolated neuron-derived exosomes (nde) and astrocytes-derived exosomes (ade) using surface biomarkers l cam (l cell adhesion molecule) and glast (glutamate aspartate transporter), respectively. this novel method involved streptavidin coated magnetic beads and photo-cleavable (pc) biotin, providing us biologically intact exosomes useful for co-culture studies. we characterized the exosomes by nanoparticle tracking analyses (nta), western blotting, flow cytometry, immunogold labelling, transmission electron microscopy (tem), elisas and mass spectrometry. respirometric profiling in cardiac myoblasts and monocytes following exosomes treatment was performed by seahorse xf. results: the quality of isolated exosomes (te, nde, and ade) was confirmed by nta (size distribution and concentration), western blotting (e.g. cd ) and tem (size and shape). nta did not show any significant difference in exosomes size and concentration (number per ml) between control and oxycodone sa groups. flow cytometry (e.g. l cam and glast) and immunogold labelling (cd , cd and l cam) confirmed the purity of nde and ade isolated from te. proteomics analyses of te, nde and ade identified several unique proteins present in exosomes from the oxycodone sa group. interestingly, we observed significantly higher expression of neurodegeneration markers neurofilament light protein (nfl) and alpha-synuclein in nde and ade of oxycodone sa group compared to controls. furthermore, te treatment of h c cardiac myoblasts and raw . monocytes significantly compromised their mitochondrial metabolism (basal and maximum respiratory capacity). summary/conclusion: these results suggest the utility of plasma exosomes as biomarkers for better understanding of the neurodegenerative and systemic effects of oxycodone addiction. funding: da , da . vesicles released during mycobacterium tuberculosis infection: immunomodulatory (glyco)lipids and role in host-pathogen interactions emilie layre, pierre boyer and jerome nigou cnrs-université paul sabatier, toulouse, france introduction: the tuberculosis disease remains one of the top causes of death worldwide. mycobacterium tuberculosis (mtb) has evolved strategies to evade immune responses and to persist within the hostile intracellular environment of alveolar macrophages. the current lack of efficient anti-tuberculosis strategies is largely due to our incomplete understanding of the host-pathogen interactions of mtb infection. vesicles released by the bacillus itself (bacterial membrane vesicles, bmv) and by infected cells (host extracellular vesicles, hev) have immunomodulatory properties in vitro and when administered to animals. if vesicles likely play key role in host-pathogen interactions of the tuberculosis infection, their content in bacterial factors, their uptake, trafficking and interaction with host cells receptors remain incompletely deciphered. methods: bmv and hev have been purified by combining differential centrifugation, density gradient and exclusion chromatography. after characterization by microscopy, nanosight and western blot, their content in bacterial (glyco)lipids has been characterized by the use of high sensitivity mass spectrometry-based lipidomic approach. bmv have been tested for their capacity to activate reporter cell lines of pattern recognition receptors. in addition, fluorescent-labelled bmv have been used to study their uptake by host cells thank to super-resolution microscopy. results: we have undertaken to characterize the content, the trafficking and interaction with pattern recognition receptors of bmv and hev released during infection by mycobacteria of variable virulence. we have importantly optimized the purification of bmv showing that lipoproteins aggregates are co-purified with vesicles on density gradient. sfc-ms lipidomic analyses allowed the characterization of the repertoire of immunomodulatory bacterial lipids released by bmv and hev, which excluded a continuum between these two release pathways. preliminary, assays have shown that these vesicles are capable to interact with different pattern recognition receptors including tlr and lectins. finally, we have been able to visualize fluorescent-labelled vesicles uptake by macrophages using superresolution microscopy. summary/conclusion: during m. tuberculosis infection, the bacillus as well as infected cells release vesicles that harbour different content in immunomodulatory bacterial (glyco)lipids, including strain-specific lipids. these vesicles likely play important role in host-pathogen interactions by modulating immune response beyond the infected cells, in part through their interaction with different pattern recognition receptors. funding: fondation pour la recherche medicale, fondation fonroga. introduction: conventional diagnoses of mycobacterium tuberculosis (mtb) rely on quantifying bacteria in sputum samples, which make it incapable of measuring the body's total bacterial load and diagnosing patients that have difficulty producing sputumsuch as children and those that are hiv-positive. nanoscale ( - nm) outer membrane vesicles (omvs), which are shed from their bacterial cells of origin and circulate in the bloodstream, have been found to contain rich molecular information from their mother cells. despite the diagnostic potential, their nanoscale size in the presence of high background has complicated the use of these promising biomarkers for clinical diagnosis of tuberculosis. chair: amy buck -the university of edinburgh chair: cherie blenkiron -the university of auckland methods: here we report two complementary approaches to systematically discover and clinically detect mtb-derived omvs using protein and rna biomarkers. first, we employ a digital droplet elisa on whole, unprocessed samples to detect and quantify the presence of these omvs using surface protein markers. second, we have developed a platform to specifically enrich for mtb-derived omvs using our previously developed magnetic nanopore platform, wherein millions of nanofluidic devices are operated in parallel, increasing throughput relative to a single nanofluidic device by a million-fold. using this approach, we identify rnas that are specifically enriched in mtb-derived omvs and can be used to identify tb strain, infectious activity, and total body burden. results: using these platforms, we enriched for mtbderived omvs from plasma and profiled their cargo, both proteins and rna. we first determined a panel of protein biomarkers for multiplexed detection of omvs through a digital droplet sandwich elisa. we then tested our protein markers on spiked plasma samples as models for clinical tb samples. simultaneously, we performed rna sequencing and discovered a panel of rna biomarkers that are preferentially enriched in omvs. we picked ten of the most highly-expressed rna biomarkers and also tested for them on spiked plasma samples using our magnetic nanopore platform. summary/conclusion: these results demonstrate the capability of omv biomarkers in the development of novel liquid biopsy based mtb diagnostics. building on this work, we are working with clinical collaborators to test our assays on clinical samples from philadelphia and west africa. funding: nih ot . introduction: a dearth of knowledge exists regarding the molecular mechanisms by which host exosomes regulate immune response to infections caused by gram-negative pathogens. to address this gap in knowledge, our laboratory has been using two wellestablished model organisms; yersinia pestis (yp), and burkholderia pseudomallei (bp). yp and bp cause the emerging human diseases plague and melioidosis respectively. currently, no licenced vaccines or highly effective therapeutics are available for either disease. methods: ex were purified from naïve u monocytes (exu) and infected u (exi) by serial centrifugation followed by sucrose density gradient purification, and characterized by tem, zetaview nanoparticle tracking, and exosome markers (cd , tsg , . immune responses of naïve u cells and response mechanisms were analysed following treatment with equivalent amounts of exi or exu (as control). these included macrophage differentiation assays, multiplex measurements of inflammatory cytokines, bacterial clearance assays, quantitative protein microarray analysis of host signalling proteins, sirna knockdown of exi-induced cytokines in recipient cells, and mass spectrometry (ms) analysis of exi contents. for all assays, at least four biological replicates were performed. results: exi induce monocyte differentiation to macrophages and dramatic release of il- , il- and il- cytokines, effects that are also seen when monocytes are infected with the bacteria. the exi also induce a substantial increase in the capacity of the recipient monocytes to clear bacteria in an il- -dependent manner. specific host signalling molecules are strongly modulated by the exi, including p , jak and alk for exi-yp, influencing the observed phenotypes. ms analysis showed lack of lps in exi-yp and demonstrated the presence of specific bacterial proteins that have antigenic properties. summary/conclusion: we have identified some of the molecular mechanisms by which exi assist the host in clearing infection. exi prime distant naïve monocytes through modulation of distinct pathways such as p to mount immune responses similar to when they become infected. these include differentiation to macrophages and migration to infection site for increased il- -dependent bacterial clearance. introduction: recruitment of monocytes to sites of infection is important in restricting growth and invasion of various microorganisms such as pathogenic fungi c. albicans. beside complement supported phagocytosis and extracellular trap formation, human monocytes secrete extracellular vesicles which are crucial in cellular communication in physiology and pathophysiology as they transfer proteins, lipid, and nucleic acids. the current study attempts to shed light on immune evasion mechanisms by c. albicans via extracellular vesicles. methods: human monocytes were isolated by magnetic beads technique and extracellular vesicles were isolated using polymer precipitation or ultracentrifugation or size exclusion chromatography. vesicles were characterized by elisa, lc/ms-based proteomics, confocal laser scanning microscopy (clsm) as well as electron-and dynamic light scattering microscopy, etc. crispr-cas based genome editing was performed to knockout cd b in human monocytic thp- cells. effect of isolated vesicles were determined by using proximity ligation assay (pla), elisa, western blot, next generation rna sequencing, qpcr, immunohistochemistry, etc. results: here we show for the first time that human blood derived monocytes alone and in a whole blood model strongly induced and released extracellular vesicles in response to the pathogenic fungus c. albicans. one induced population carried the anti-inflammatory cytokine tgfβ- . release of these vesicles is triggered by binding of soluble β-glucan from c. albicans to the cr receptor on monocytes as demonstrated by crispr-cas based cr genome editing in thp- cells, and by using cr knock out mice. isolated tgf-β -transporting vesicles reduced the inflammatory response in human m macrophages and in a whole blood model. the anti-inflammatory effect by tgf-β transporting vesicles is investigated in detail and results in inhibition of il- β gene transcription. summary/conclusion: showing that human apoptotic bodies similarly induced tgf-β -transporting vesicles from human monocytes we hypothesize that c. albicans hijacks this new cr -dependent anti-inflammatory vesicle pathway for immune escape. funding: this work was supported by the "deutsche forschungsgemeinschaft" transregio funginet projects c , c , c and z . introduction: to date, most research involving extracellular rnas has focused in rnas encapsulated inside extracellular vesicles (evs) or in total unfractionated biofluids. it is known that exrnas also exist outside vesicles or in lipoprotein particles. however, nonvesicular exrnas remain widely uncharacterized despite being a feasible source of contaminants in ev preparations. our interest in nonvesicular exrnas arises from the observation that some small rnas, such as specific trna-derived fragments, have much higher relative representation in this extracellular fraction. at least in part, this enrichment seems to be a consequence of their differential extracellular stability. methods: to get a representative picture of the whole set of rnas released to the extracellular nonvesicular space by cultured human cells, we inhibited extracellular degradation by adding recombinant ribonuclease inhibitor to the cell-conditioned media and studied the kinetics of rna release and degradation. high-resolution iodixanol gradients were used to separate evs from extracellular rnps or vesicle-free rna. the conversion rate between parental ncrnas and their fragments was studied by high-throughput sequencing and northern blot. results: the inhibition of extracellular rnase activity revealed the presence of full-length trnas and ribosomes in the extracellular space of a variety of malignant and non-malignant cell lines. extracellular ribosomes co-isolate with evs purified by ultracentrifugation or size-exclusion chromatography, but not with evs purified by density gradients.these ncrnas are substrates of extracellular rnases, demonstrating an extracellular biogenesis route for the formation of ncrna-derived fragments, some of which achieve remarkable stability and can be detected in biofluids. we also highlight the immunoregulatory potential of purified rna-containing extracellular complexes. summary/conclusion: in conclusion, ribonuclease inhibition dramatically shapes extracellular rna profiles and uncovers a population of extracellular ribosomes, trnas and other coding and noncoding rnas which exists outside evs. although these rnas are prone to degradation, some of their fragments can accumulate in cell culture media and in biofluids. this dynamic view of exrnas impacts our understanding of rna secretion mechanisms and may offer a window to new molecules with biomarker potential. in contrast, evs confer an rnase-protected environment and contain more full-length ncrnas (trnas, yrnas, sl rnas, rrnas depending on vesicle size) than their fragments. introduction: cd is a ubiquitously expressed membrane protein that functions as a receptor for thrombospondin- and the counter receptor for signal regulatory protein-α in phagocytes. high expression of cd is associated with a poor prognosis for some cancers. conversely, cd blocking agents are in clinical trials for enhancing innate and adaptive antitumor immunity in cancer patients. these studies suggest utility of cd as a diagnostic and prognostic biomarker and as a therapeutic target. cd is also expressed on extracellular vesicles (evs), and we reported that cd expression identifies a distinct population of evs from those that express the traditional ev markers cd or mhc . cd -, cd -and mhc -enriched vesicles contain distinct small rna populations (pmid: ), and these differ in rna content from evs that lack any of these markers. the mechanisms by which cd directly or indirectly regulates which rnas are packaged into ev remain unknown. methods: to elucidate the mechanism by which cd regulates ev rna composition and function, we performed global mirna microarray analysis between evs produced by wild type and cd -deficient t cells. results were further validated using real-time pcr and rna-immunoprecipitation. interactions between cd and exportin- /ran complex was identified by mass spectrometry and confirmed by using co-immunoprecipitation, subcellular localization, flow cytometry, and confocal and electron microscopy. results: ev released from cd -deficient human t cells and in cd -/-mouse plasma were enriched in ʹ- -methylguanosine-capped micrornas and mrnas that depend on the exportin- /rangtp pathway. knockdown of cd in wild type cells or thrombospondin- treatment correspondingly enhanced levels of capped-rnas released in ev and re-expressing cd in null cells decreased their levels. mass spectrometry and co-immunoprecipitation identified specific interactions of cd with components of the exportin- / ran nuclear export complex and its known cargos and between the cd cytoplasmic adapter ubiquilin- and the exportin- /ran complex. interaction of cd with exportin- was inhibited by leptomycin b, which inactivates exportin- and increased levels of cap-dependent rnas in ev released from wild type but not cd -deficient cells. summary/conclusion: these findings indicate that cd -dependent thrombospondin- signalling regulates cytoplasmic levels of cap-dependent rnas in t cells at least in part through ubiquilin- -and gtpdependent physical interactions with the exportin- / ran transport complex, which regulate levels of specific pre-mirnas and mrnas available for sorting into evs. funding: this work was supported by the intramural research program of the nih/national cancer institute (zia sc ). role of membrane protein palmitoylation in extracellular vesicle biogenesis in squamous cell carcinoma introduction: desmoglein (dsg ), is a palmitoylated cadherin that is involved in cell-cell adhesion. interestingly, dsg promotes mitogenic cell signalling and is upregulated in many cancers, including scc, contributing to poor prognosis and survivability. we recently demonstrated that dsg promotes ev release, but the mechanism by which dsg enhances ev biogenesis and role of palmitoylation is poorly understood. methods: pharmacological drug inhibitors -bromopalmitate, gw , and bafilomycin a were used. stable scc cell lines were established by retrovirus infection expressing gfp, wild type dsg /gfp, or palmitoylation deficient dsg cacs/gfp. evs were isolated by sequential ultracentrifugation and iodixanol gradient separation and analysed by nta. proteins associated with the endocytic pathway were analysed by immunofluorescence and imaged by confocal microscopy or immunoblotting and signals were quantitated using imagestudio. results: here we demonstrate that the effect of dsg on ev release was reduced by the palmitoylation inhibitor -bromopalmitate. furthermore, mutations that prevented palmitoylation (dsg cacs) dramatically abrogated ev release by targeting of un-palmitoylated dsg to the lysosomes for degradation. dsg increased expression and subcellular localization of flot , a membrane lipid raft protein critical for membrane invagination. dsg also altered membrane localization of several early (eps and eea ), but not late (rab , rab , and hrs), endocytic pathway proteins. loss of palmitoylation in the dsg cacs mutants abrogated these effects. finally, dsg -induced ev release was abrogated by the sphingomyelinase inhibitor gw or augmented by the v-atpase inhibitor bafilomycin a . summary/conclusion: the combined results of the drug treatments and functional mutations of dsg suggest that dsg plays a critical role in ev biogenesis by modulating proteins involved in early endosome sorting and is dependent on post-translational palmitoylation. introduction: the translation initiation factor eif e ( e) is an oncogenic protein that is upregulated in % of cancers including a subgroup of acute myeloid leukaemia (aml) patients. eif e regulates post-transcriptional rna processing including the nuclear export and/or translation of mrna transcripts. in particular, it selectively increases the expression of genes that have a prominent role in cancer progression such as myc, cyclin d , and mcl . furthermore, our lab pioneered studies demonstrating that a subset of ehigh aml patients is clinically responsive to treatment with a e inhibitor (ribavirin) indicating the importance of e in aml progression and its relevance as a therapeutic target. we investigated an as yet unexplored perspective of e-whether the oncogenic role of e is in part mediated by its function as a master regulator of vesiculation. methods: to assess mrna export and identify ebound mrna targets that correspond to vesiculationrelated genes and associated cargo, we used cellular fractionation and rna immunoprecipitation techniques. to determine whether e regulates the number of extracellular vesicles (evs) released as well as their protein and rna cargo we used nanoparticle tracking analysis (nta) as well as mass spectrometry, antibody microarrays, and rna sequencing technologies. results: eif e upregulates cellular protein levels of the vesiculation marker cd by increasing its nuclear export. in addition to increased cellular expression, cd , cd , cd , and flotillin- proteins are elevated in evs released from e-high cells. this is also associated with an increased release of vesicles that are - nm in size. currently, we have validated the upregulation of several receptors and cytosolic proteins in evs isolated from e-overexpressing cells that function in cell growth, migration, invasion, and stemness. the most abundant rnas in our ev preparations are micrornas (mirs) and we have confirmed downregulation of several of these. summary/conclusion: our work shows that e reprograms the vesiculation of cancer cells changing the release and cargo of evs. this may impact cellular communication and tumour biology, which we are currently addressing in functional studies. we hope that these studies will highlight novel therapeutic strategies for aml patients. intranasal administration of neural stem cells-derived extracellular vesicles promotes neurogenesis and reduces neuroinflammation and amyloid plaques in a mouse model of alzheimer's disease introduction: cognitive and memory impairments worsen with time in alzheimer's disease (ad), likely due to a progressive loss of hippocampal neurogenesis, and escalation of neuroinflammation. these changes are also accompanied by increased deposition of amyloid plaques in the brain. methods: in this study, using the xfad mouse model, we examined the efficacy of extracellular vesicles (evs) shed from the rat subventricular zone neural stem cells (svz-nscs) for disease modification. we first purified evs from the rat svz-nsc cultures through ion-exchange chromatography and then administered intranasally to -months old xfad mice (~ billion/week for two weeks). two months later, the functional effects of ev treatment were quantified through a series of behavioural tests, and animals were euthanized for quantification of hippocampal neurogenesis, oxidative stress, neuroinflammation, and amyloid plaque deposition. results: in comparison to ad mice receiving vehicle, ad mice receiving nsc-evs displayed improved cognitive function to discern minor changes in the environment in an object location test, better spatial recognition memory in an object-in-place test, and improved pattern separation ability in a pattern separation test. besides, ev-treated ad mice displayed no anhedonia in a sucrose preference test. analyses of neurogenesis using the birth-dating marker ʹ-bromodeoxyuridine and the newly born neuron marker doublecortin revealed maintenance of a higher level of hippocampal neurogenesis in ad mice receiving evs, in comparison to vehicle-treated ad mice. moreover, analyses of brain tissues from ev-treated ad mice revealed decreased concentrations of oxidative stress markers malondialdehyde and protein carbonyls and elevated levels of antioxidants catalase and superoxide dismutase. also, the concentration of proinflammatory cytokines tumour necrosis factor-alpha and interleukin- beta and the extent of amyloid plaques were significantly reduced in ev treated ad mice. immunohistochemical analysis showed reduced hypertrophy of astrocytes. summary/conclusion: intranasal administration of nsc-derived evs restrains the deterioration of cognitive and mood dysfunction of ad by maintaining higher levels of neurogenesis and curtailing the progression of neuroinflammation. funding: supported by a grant from the national institute of neurological disorders and stroke ( r ns - to a.k.s.) ot . the case of mesenchymal stromal cells, opening new perspectives in the use of ipsc in regenerative medicine. the aim of this study is to evaluate the potential of ipsc-ev in the treatment of kidney disease. methods: the ipsc were generated from skin fibroblast after informed consent of healthy donors (cytotune®-ips . sendai reprogramming kit -protocol: clementino fraga filho uh . . . / . ). the ev were isolated from ipsc supernatants (cultured h in mtesr- medium) by ultracentrifugation ( , g for h at °c). characterization of ipsc-ev was performed using zetaview, tem, exoview™ tetraspanin kit and macsplex exosome kit. for in vitro injury, renal epithelial cells were cultured under hypoxia ( % o ). for in vivo injury, male wistar rats were submitted to bilateral renal arterial clamping ( min) followed by reperfusion without or with injection of ipsc-ev (protocol approval: federal university of rio de janeiro - / ). kidney damage was assessed by histological and immunohistochemistry analyses (pcna, tunel and ed- ). modulation of rna levels was assessed by rt profiler pcr array. results: the results show that ipsc-ev reduce renal cell death, tissue damage, macrophage infiltration, promote mitochondria protection and ameliorate renal function. the ipsc-ev mechanism of action is related to the regulation of key genes known to prevent damage caused by oxidative stress like gstk , sod , sod , txn and txnrd . characterization of ipsc-ev showed that ipsc-ev can carry important molecules that can support renal recovery as epcam and prominin- . summary/conclusion: ipsc-ev presents renoprotective properties, acting on different aspects of aki. this presents a new relevant application of ipsc as a source of ev for therapeutic purpose in kidney diseases. the hospital for sick children, toronto, canada introduction: incomplete lung development, also known as pulmonary hypoplasia (ph), is a recognized cause of neonatal death. we have previously shown that experimental ph can be rescued by the administration of extracellular vesicles derived from amniotic fluid stem cells (afsc-evs) through an rna-mediated mechanism. this effect was not observed with evs derived from mesenchymal stromal cells (msc-evs) . the aim of this study was to ) evaluate which rna species were responsible for ph rescue, and ) to define the mechanism behind this effect. methods: evs were isolated and characterized from conditioned medium of rat afscs and rat mscs (control group) using ultracentrifugation. evs were assessed for size (nanoparticle tracking analysis), morphology (tem), and expression of cd , hsp , flo- , and tsg (western). to identify the mediators of afsc-evs, we used deseq (fdr< . ) to differentially analyse rna from: a) asfc-ev and msc-ev cargo, isolated with seramir and sequenced with nextseq. b) lung epithelial cells from rat ph lungs treated with vehicle or afsc-evs. epithelial cell rna was isolated with mirvana and sequenced with nextseq. we correlated afsc-ev cargo mirna with validated mrna targets that were downregulated after ev conditioning in lung epithelial cells. results: of the rna species contained in asfc-ev and msc-ev cargo, mirnas were the most proportionally different between the two ev populations. afsc-evs were enriched for mirnas that are critical for lung development, such as mir ~ and their paralogues that control lung branching morphogenesis. afsc-ev administration to ph lung cells significantly downregulated genes, which formed mirna-mrna reported interactions. summary/conclusion: afsc-evs contain many rna species in their cargo, but mirnas are the main effectors of their ability to rescue underdeveloped foetal lungs. we have identified for the first time that afsc-ev biological effect on underdeveloped foetal lungs is in part due to the release of mir ~ cluster. funding: cihr-sickkids foundation grant. bottom-up assembly of fully-synthetic extracellular vesicles oskar staufer a , franziska dietrich a , jochen hernandez a , martin schröter a , sebastian fabritz b , heike böhm a , ilia platzman a and joachim spatz a a max planck institute for medical research, department for cellular biophysics, jahnstraße , heidelberg, germany, heidelberg, germany; b department for chemical biology, max planck institute for medical research, jahnstraße , heidelberg, germany, germany, germany introduction: extracellular vesicles (evs) are considered as key elements for future therapeutic and diagnostic procedures. however, despite enormous research efforts to understand their physiological relevance and several greatly successful clinical trials, evs are currently not authorized for clinical routines by american or european regulation and approval agencies. this is especially because therapeutic evs are produced or isolated from cell cultures or biofluids, both of which are subjected to batch-to-batch variations and ill-defined contaminations. therefore, complementary technologies that produce evs as reproducible and defined as state of the art nanotherapeutics, would revolutionize the application of evs in clinical settings and provide the scientific community with a holistic understanding of ev-mediated signalling processes. in our study, we achieve de novo bottom-up assembly of fully synthetic evs (fsevs) that comprise identical physiological and therapeutic functionalities to natural evs. methods: we applied droplet-based microfluidic synthesis to sequentially amalgamate synthetic lipids, proteins and nucleic acids into defined vesicles that display analogous therapeutic capabilities to natural evs. fsevs were characterized by electron and confocal microscopy, dynamic light scattering and mass spectrometry and tested on organotypic models or in vivo. results: using previously described evs as "naturegiven" blueprints, we assembled several fsevs in their exact molecular composition. in particular, we produced wound-healing promoting evs composed of several exosomal proteins, lipids and micrornas and showed that their therapeutic performance on human skin wounds is equivalent to that of natural evs. besides their high molecular complexity, being composed of dozens of different molecular building-blocks, the presented fsevs are completely defined on a quantitative level. based on this, we achieved a stoichiometric understanding of cell-vesicle interactions. summary/conclusion: by applying bottom-up synthesis of fsevs for quantitative studies on ev signalling, we not only provide innovative and safe compounds for ev-therapeutics but also a vastly new perspective on the application spectrum of extracellular vesicles in fundamental research. introduction: small extracellular vesicles (sevs) contain functional molecules from their cell of origin and can enter recipient cells for intercellular communication. ifnβ has been shown to induce some lncrnas to regulate host immune response and play a major role in the positive regulation of the activity of natural killer (nk) cells. here, we aim to clarify whether ifnβ induced sevs can regulate the cytotoxicity of nk cells by transferring specific lncrnas into nk cells. methods: evs were purified from a with/without ifnβ treatment by serial centrifugation followed by sucrose density gradient purification. elisa assay were performed to demonstrate the cytotoxicity of nk cells. qpcr and western blot were used to verify the expression of nkp . results: surprisingly, ifnβ induced sevs can strengthen the cytotoxicity of nk cells. through human transcriptome array (hta) we found the expression levels of lncrnas were significantly changed within sevs isolated from a cells following ifnβ treatment. additionally we found a specific sev cargo, linc-epha - , acted as a competing endogenous rna (cerna) for hsa-mir- which subsequently up-regulate the natural cytotoxicity receptor (nkp ) expression. furthermore, we verified over-expression of linc-epha - significantly enhance the cytotoxicity of nk cells against zika virus-infected a cells. summary/conclusion: our results demonstrated that ifnβ-induced linc-epha - wrapped in sevs can regulate the cytotoxicity of nk cells. our study provides a novel link between type i ifn and nk cells, which are two major players for the host innate immunity against pathogen infections. introduction: hiv-infected t cells release simultaneously viral particles and small extracellular vesicles (sevs) including mvb-derived exosomes and plasma membrane-derived evs. sevs and hiv share many physical and chemical characteristics, which makes their separation difficult. although several approaches have been used to obtain sevs free of virus they leave a majority of sevs within hiv preparations. for this reason, the function of sevs during hiv infection remains unclear. methods: we have developed a novel un-biased proteomic profiling approach to identify specific markers of the virus or sev subtypes released by a human t lymphoma cell line. our approach was to combine differential centrifugation of medium/small evs contained in the ccm with quantitative mass spectrometry to generate protein abundance profiles across the different sub-fractions. we generated an interactive database to define groups of proteins with similar profiles, suggesting their release in the same evs. results: we thus identified different categories of evs, which bear different surface proteins, e.g. different combinations of t cell surface markers, integrins or tetraspanins. in evs released by infected cells, we identified cellular proteins behaving like hiv proteins, and several that changed behaviour after infection, either moving towards or away from the hiv cluster. we identified two cell-derived proteins that are included in the viral particles and one that is specific of non-viral sevs that are modified by infection, and analysed their respective roles in controlling ev composition or virus infectivity. summary/conclusion: our approach presents a powerful tool for identification of common cargoes of given ev subtypes, and could be now used to identify modifications of ev composition in any given physiological or pathological situation. the encephalomyocarditis virus leader modulates autophagic pathways to promote the release of virions inside extracellular vesicles introduction: recent data indicate that naked viruses belonging to the picornaviridae family can be released from host cells via enclosure in extracellular vesicles (ev). ev cloak virus particles in a host-derived "envelope" and can thereby affect antiviral immune responses and disease severity. a better understanding of the formation and function of ev-enclosed viruses is therefore required. previously, we showed the presence of the autophagosome marker lc in ev isolates from encephalomyocarditis virus (emcv) infected cells, suggesting the involvement of a secretory autophagy pathway in ev-mediated virus release. however, little is known about the viral and host factors that regulate this process. here, we have assessed the role of the emcv leader, a viral protein that is dispensable for replication but is required for symptomatic disease. methods: cells were infected with wildtype virus or a mutant carrying an inactive leader. ev produced during the infection were isolated using differential ultracentrifugation and density gradient purification. ev were characterized by high resolution flow cytometry and their infectivity determined using end-point dilution assay. in addition, the fate of autophagosomes in infected cells was monitored using a reporter assay for autophagosome-lysosome fusion and analysis of the secretion of autophagosomal proteins. results: inactivation of the emcv leader strongly reduced the release of ev-enclosed virus. whereas autophagosomes are typically degraded, we show this is blocked by the leader. instead, autophagosomes fuse with the plasma membrane, as indicated by the secretion of autophagy marker lc during infection with wildtype but not the mutant virus. pharmacological reactivation of degradative autophagy in infected cells resulted in a strong reduction in the release of ev and ev-enclosed virus. similarly, the reduction in evenclosed virus release in the absence of the leader could be partially reversed by drugs that promote the secretion of autophagosomes. summary/conclusion: our data supports a role for secretory autophagy in the release of viruses in ev, a pathway that is regulated by the emcv leader. these findings highlight an unconventional route for ev formation that intersects with autophagosomal compartments and contributes to viral pathogenesis. introduction: zika virus (zikv) causes a public health emergency of international concern because of its correlation with microcephaly. during viral infection, the innate immune response quickly to produce some endogenous functional molecules which can prevent viral invasion or replication. extracellular vesicles (evs) contain molecules from their cell of origin under virus infection and can enter recipient cells for intercellular communication. here, we aim to clarify whether zikv induced evs can regulate viral pathogenicity by transferring specific rna. methods: evs were purified from a with/without zikv infection by serial centrifugation followed by sucrose density gradient purification. human transcriptome array (hta) was used to found rna expression within evs. flow cytometry was used to determine cell cycles. zikv replication was assayed by qpcr and western blot. flow cytometry was used to determine cell cycles. results: through hta we found the defensin alpha b (defa b) expression was significantly increased within evs isolated from zikv infected a cells. additionally, we found that the extracellular defa b but not the intracellular defa b exerts anti-zikv effect mainly before entry step. surprisingly, up-regulate defa b can retard cell cycles of host cell. we verified defa b could bind with the origin recognition complex (orc ) which is required to start dna replication during the cell cycle. furthermore, up-regulate defa b decreased the orc level in nuclear. interestingly, evs with defa b can internalize into recipient cells and inhibit their cell cycles. summary/conclusion: together, our results demonstrated that zikv infection can induce defa b wrapped in evs, and defa b not only exerts anti-zikv effect but also regulate cell cycles which may affect neurodevelopment. our study provides a novel viewpoint that defa b act as first-line anti-viral molecules during zikv infection also correlate with neurodevelopment by retarding cell cycles. extracellular vesicles mediate bacterial-immune cell interactions during respiratory viral-bacterial co-infections sidney w. lane a , matthew hendricks b and jennifer bomberger a a university of pittsburgh, pittsburgh, usa; b university of washington, seattle, usa introduction: respiratory infections are a major cause of morbidity and mortality worldwide and host-derived extracellular vesicles (evs) play important roles in mediating these infections. during respiratory infection, evs are shown to have a modulatory effect: promoting or suppressing infection dependent on the pathogen and cell type. in the age of next-generation sequencing, we now appreciate that many respiratory infections are polymicrobial in nature, with viral-bacterial co-infections correlating with worse disease outcomes. epidemiological studies correlate acute viral infections with the increased likelihood and severity of both acute and chronic secondary bacterial infections; however, the exact mechanisms of these interactions remain poorly understood. evs have been understudied in the context of respiratory viral-bacterial coinfections; thus, their role in mediating these infections is relatively unknown. unpublished data from the lab shows that in airway epithelial cells (aecs), viral infection induces the release of evs that associate with pseudomonas aeruginosa (pa) and promote biofilm growth. here, we aim to expand upon these findings and determine how aec evs mediate pa-immune cell interactions during respiratory viral-bacterial co-infection. methods: to determine how exposure to evs impacts pa-immune cell interactions, evs were isolated from the apical secretions of aecs and co-cultured with pa. ev-treated pa was then co-cultured with macrophages to evaluate ev impact on pa uptake and survival. results: in preliminary experiments using control evs, we observed that evs associate with pa. interestingly, during co-culture with macrophages, ev-treated pa are more susceptible to phagocytosis in comparison to non-treated pa. however, after hours of co-culture with macrophages, ev-treated pa are able to survive and replicate, while nontreated pa are effectively controlled by the macrophages. summary/conclusion: these findings suggest that while pa-ev association promotes pa uptake, it may ultimately enhance pa immune evasion and survival. ongoing experiments in the lab are evaluating the mechanism of pa-ev association and how evs from virus-infected aecs affect the phenotypes observed with control evs. notably, this is one of few reports of a mammalian ev influencing the pathogenesis of a bacterium; thus, results from these experiments will define the function of aec evs in regulating bacterial-immune cell interactions during respiratory co-infections. using machine learning with neuronal ev target proteins and clinical data to predict cognitive impairment in hiv infection lynn pulliam a , michael liston b , bing sun c and jared narvid d a university of california, san francisco, san francisco, usa; b veteran affairs, san francisco, usa; c ncire, san francisco, usa; d ucsf, san francisco, usa introduction: objective biomarkers are needed to assess and predict neuronal function and cognitive impairment. in people ageing with chronic infections, such as hiv, determining the mechanism of impairment will be important when therapies are available. methods: sixty plasma samples from hiv-infected people were obtained from nih-sponsored aids banks. clinical and epidemiological data were collected. all underwent neuropsychological testing and were considered impaired. neuronal extracellular vesicles (nevs) were isolated from plasma and assayed for high-mobility group box (hmgb ), neurofilament (nf-l) and phosphorylated tau- (p-tau) proteins. results: using different algorithms, support vector machines (svm) performed the best with an area under the curve (auc) value of . ± . . using different combinations of clinical data and the nev protein targets, selected clinical data and hmgb best predicted cognitive impairment (auc = . ). the most important features included cd count, hmgb , nf-l and education. summary/conclusion: specific clinical features plus nev hmgb , an inflammatory marker, were the best predictors of cognitive impairment. previous published data showed nev p-tau- elevated in alzheimer's disease and in this study p-tau had no importance in assessing hiv-associated cognitive impairment. nev target discovery can be improved to better identify neuronal damage, possibly to differentiate other neurodegenerative diseases and hopefully recovery after therapies are identified. in recent years, we have been able to separate and characterize extracellular vesicles (evs) from several different viruses including hiv- , htlv- , rift valley fever virus and ebolavirus. however, to date it is not clear whether there is a timing difference between ev and virus release from infected cells. methods: ev isolation by nanoparticle capture and differential centrifugation, ev quantification by nanoparticle tracking analysis, western blot, rt-qpcr, virus rescue assay. results: we have attempted to address the kinetics of ev and virus release from multiple-infected cells using serum starvation experiments from infected ( %) cells. these infected cells were initially put in g quiescent stage using serum starvation. both supernatants and cell pellets were collected postinduction release ( % fbs + pma/pha) at , , , , and hours and examined for the presence of ev, autophagy and viral proteins as well as viral rna expression. results from supernatants of uninfected cells showed a peak of tetraspanin proteins (cd , cd , and cd ) at hours and a gradual decrease of all ev associated proteins by hours. however, the ev from hiv- infected cells showed all three tetraspanins present at hours and expression gradually increased up to hours. when compared to htlv- infected cells, the three tetraspanin proteins peaked at hours and expression continued to decrease up to hours. htlv- infected cells also showed a unique pattern of cd expression. autophagy associated proteins (lc a, lc b and p ) from uninfected cells and htlv- infected cells plateaued at hours, whereas in hiv- infected cells their expression continued to increase and peaked at hours. hiv- viral proteins (p , gp , nef) expression was present at hours and continued to increase and peaked at hours. htlv- proteins (p and gp / ) peaked at hours and gradually decreased overtime. hiv- and htlv- rna gene expression analysis was performed, and data correlated with viral protein expression. additionally, evs release was quantified and showed significant increase of ev concentration overtime in both uninfected and infected samples. finally, experiments of infectivity from -and hour supernatants were performed on three naive cells. hiv- supernatant -hour sample was found not to be infectious. however, hiv- was successfully rescued from -hour sample. introduction: urinary extracellular vesicles (uevs) are important intercellular communicators. by systems biology integration, uevs prove to be relevant in genitourinary disease detection. however, it has recently been shown that labelled evs administered to the circulation can be detected in the urinary system, as well. thus, this pilot study aimed at phenotyping haematopoietic surface markers on uevs to create enough plausibility for future non-invasive biomarker studies of circulation and immune disorders that may translate into urine but are not yet timely recognized. methods: urine was obtained from healthy men signing a written informed consent (n = ). sampling was approved by the local ethics committee and in compliance with the declaration of helsinki. cell-free urine was obtained by serial centrifugation and ml, each, were utilized for the macsplex exosome kit, human (miltenyi biotec). the manufacturer's recommendations were followed to examine distinct uev surface markers of cd +/cd +/cd + vesicles in a multiplexed bead-based manner including respective controls. the accuri c (bd) was utilized for data acquisition. for further misev -compliant characterization, cd +/cd +/cd + uevs were isolated by immunoaffinity and analysed by fluorescence nanoparticle tracking (f-nta), transmission electron microscopy (tem) and western blotting (wb). urinary creatinine (ucrea) was determined to control for variances in urinary dilutions and used for data normalization. results: except cd , all other surface markers could be identified. the most abundant markers were cd and cd , which were detected in % of samples, followed by cd / ( %), cd ( %), cd and cd ( %, each). cd ( %), cd , cd ( %), cd e ( %) and cd showed similar relative median fluorescent intensities (rmfi), while cd yielded significantly higher (p = . ) and all other markers significantly lower rmfi (p < . ). tem and f-nta revealed cup-shaped vesicles ( ± nm) with . ± . e + particles/g ucrea. wb indicated uev isolates that were positive for alix, syntenin, tsg , cd , cd and cd without any uromodulin or calnexin contamination. summary/conclusion: our results imply that considerable quantities of circulatory evs are, indeed, filtered into urine and could serve as valuable non-invasive biomarkers for systemic dysfunctions. cardiovascular risk markers are strongly related to numbers of circulating extracellular vesicles ruihan zhou a ,esra bozbas a , plinio ferreira b and parveen yaqoob a a university of reading, reading, uk; b imperial college london, london, uk introduction: extracellular vesicles (evs) are small plasma membrane-derived vesicles released from various cells, which potentially affect many physiological and pathophysiological processes, and are emerging as a potential novel biomarker in cardiovascular diseases (cvds). however, there is little information about the association of circulating ev levels with traditional cardiovascular risk markers and cvd risk score. methods: • subjects (n = ) aged - yrs with moderate risk of cvds were recruited and assessed for body mass index (bmi), blood pressure (bp) and plasma lipid profile (triacylglycerol, total cholesterol and high-density lipoprotein). • evs were isolated from platelet-free plasma by size exclusion chromatography and analysed by both nanoparticle tracking analysis (nta) and flow cytometry (fcm). nta was used to measure the concentration and size distribution of evs population, and evs were phenotyped by fcm via a -colour panel, which included annexin v (for the majority of circulating evs), cd (for platelet-derived evs) and cd (for endothelial-derived evs). • the association between risk markers and ev numbers was examined by pearson's correlation coefficient and stepwise multivariate regression model. analysis of covariance (ancova) was performed after adjustment for various variables to determine the correlation between the quartile range of ev numbers and -yr cvd risk detected by qrisk . results: ev numbers, as determined by nta, were strongly associated with bmi (r = . , p < . ), blood pressure (systolic bp: r = . , p = . ; diastolic bp: r = . , p < . ) and plasma triacylglycerol levels (r = . , p < . ). plasma total cholesterol level was positively associated with platelet-derived evs, determined by fcm (r = . , p = . ). a multivariate regression model demonstrated that plasma triacylglycerol and diastolic bp independently predicted total ev numbers, with plasma triacylglycerol concentrations explaining . % of the variance for total ev numbers. an additional . % of the variance in total ev numbers was predicted by diastolic bp. ancova of the -yr cvd risk score in the quartile range of total ev numbers were positively and independently associated. summary/conclusion: bmi, blood pressure, plasma triacylglycerol and total cholesterol levels are strongly associated with ev numbers. plasma triacylglycerol and diastolic bp independently predict circulating ev numbers. elevated numbers of evs are independently associated with -yr cvd risk. introduction: extracellular vesicles from cardiospherederived cells (cdc-evs) are known to be anti-inflammatory in various disease models. to further dissect the mechanism, we examined the effects of cdc-evs on t lymphocytes. methods: naïve cd + t cells were isolated from secondary lymphoid organs of foxp -rfp reporter mice, using magnetic-activated and fluorescence-activated cell sorting. cells were subsequently polarized into effector subtypes (th , th , and th ), as well as regulatory t cells (tregs), and the effects of exposure to human-derived cdc-evs on proliferation and cytokine production were assessed. cdc-evs were isolated from serum-free, -day conditioned medium, using ultrafiltration by centrifugation. results: after polarization and culture for days, cdc-evs resulted in dose-dependent and cell-specific proliferative responses. effector t cells (th , th , th ) showed either no change in proliferation (th ) or decrease in proliferation (th , th ), compared to the vehicle control. in contrast, tregs proliferated much more than control (p < . ). next, we sought to characterize the changes in cytokine production by each effector t cell and tregs. compared to the vehicle control, exposure of polarized effector t cells to cdc-evs had little effect on the expression of characteristic cytokine genes, including ifnγ and tnfα (th ), il and il (th ), or il a and il f (th ). in contrast, exposure of tregs to cdc-evs resulted in~ -fold increase in expression of il , a key paracrine agent utilized by tregs in suppression of inflammation. this response was specific to cdc-evs insofar as it was not recapitulated with dermal fibroblast exosomes. concentrations of il- in the culture media of cdc-ev-conditioned tregs mirrored the increases in gene expression. summary/conclusion: cdc-evs potentiate tregs by increasing their proliferation and enhancing production of il- . this offers an attractive therapeutic approach to inflammatory diseases that relies on harnessing an endogenous mechanism of immunosuppression. funding: nih t hl . prostanoids impair platelet reactivity, thrombus formation and platelet extracellular vesicle release in patients with pulmonary arterial hypertension aleksandra gąsecka a , marta banaszkiewicz b , rienk nieuwland c , edwin van der pol d , najat hajji e , hubert mutwil f , sylwester rogula a , wiktoria rutkowska a , szymon darocha g , grzegorz opolski a , krzysztof j. filipiak f , adam torbicki g and marcin kurzyna g introduction: prostanoids (epoprostenol, treprostinil and iloprost) induce vasodilation in advanced pulmonary arterial hypertension (pah) but also inhibit platelet activation, thereby increasing the risk of bleeding. therefore, the platelet function and extracellular vesicle (ev) concentrations were measured in pah patients treated with prostanoids and compared to patients with pah not receiving prostanoids. methods: venous blood was collected from patients treated with prostanoids (study group; n = , ± years, % female) and patients not treated with prostanoids (control group; n = , ± years, % female). platelet reactivity was analysed in whole blood by impedance aggregometry using arachidonic acid (aa; . mm), adenosine diphosphate (adp; . µm) and thrombin receptor-activating peptide (trap; µm) as agonists. in a subset of patients, concentrations of evs from platelets (cd + and cd p+; pevs), leukocytes (cd +, levs) and endothelial cells (cd +, eevs) were measured in plateletdepleted plasma by flow cytometry (a -micro). platelet-rich thrombus formation was measured using a whole blood perfusion system. results: compared to the control group, patients treated with prostanoids had lower platelet reactivity in response to aa and adp (p = . ) and lower concentrations of pevs and levs (p ≤ . ). furthermore, thrombus formation was delayed (p ≤ . ) and thrombus size was decreased (p = . ) on prostanoids. epoprostenol did not affect platelet reactivity in vitro, but decreased the concentrations of cd + pevs (p = . ). in contrast, treprostinil and iloprost decreased both platelet reactivity in response to aa and adp (p ≤ . ) and the concentrations of pevs (p ≤ . ). all prostanoids delayed thrombus formation and decreased thrombus size (p ≤ . ). introduction: progressive lung disease is the leading cause of mortality in cystic fibrosis (cf), a chronic condition characterized by recruitment of polymorphonuclear neutrophils (pmns) into the airways. newly arrived pmns are exposed to extracellular vesicles (evs) from the airway epithelium and pmns recruited before them. in controlled experiments, these evs were necessary and sufficient to induce pathological changes including reduced bacterial killing and immunosuppressive activities towards macrophages and t-cells. however, children with cf do not always show a high pmn presence in their airways, which suggests that the balance between pmn recruitment and the activity of other cells is still in flux in early stage disease. methods: we utilized spectral nanoflow cytometry to profile the single ev content of the bronchoalveolar lavage fluid (balf) from cf children (< years of age). for nanoflow cytometry, evs were stained with di- -anepps, and with epcam, cd b and cd (to ascertain epithelial, pmn, and macrophage origins, respectively). violet side scatter and/or fluorescence threshold triggering were used for ev detection. results: the ratio of neutrophil-to epithelial-derived evs in cf balf correlated positively with the percentage of pmns that are present in the airways (p = . , spearman's rho = . ). this ratio also correlated with the pragma disease score, which quantifies airway damage by chest computed tomography (p = . , rho = . ). summary/conclusion: using a method to quantify evs from specific cell types in vivo, we demonstrated that the ratio of pmn-and epithelial cell-derived evs tracks with airway damage and neutrophil influx, suggesting a critical interplay between these cells in early cf disease. this ev-focused method can be applied to other diseases in which sampling cells is difficult. future experiments will use cf balf biobanks to strengthen data presented here. funding: cf foundation (tirouv a ), emory pediatrics flow core. the potential of crude extracellular vesicle micrornas for the diagnosis of community-acquired pneumonia and for the detection of pneumoniarelated sepsis as a severe secondary complication introduction: circulating cell-free micrornas (mirnas), often associated to extracellular vesicles (evs), are essential for cell-cell communication in the pathogenesis of infectious pulmonary disorders. as early pneumonia diagnosis is often clinically challenging, advances in disease detection could improve outcomes. we characterized crude ev mirnas as potential biomarkers for community-acquired pneumonia and sepsis as a severe secondary complication. methods: individuals were enrolled into our study, subdivided into a training (volunteer n = , pneumonia n = , sepsis n = ) and testing cohort (volunteer n = , pneumonia n = , sepsis n = ). after precipitating crude evs from sera (mircury exosome isolation kit-serum and plasma) and extracting total rna, small rna sequencing was performed. mirnas were selected as biomarker candidates by differential gene expression analysis (deseq ) and sparse partial-least-squares discriminant analysis (mixomics). technical and biological validation was performed by reverse transcription quantitative realtime pcr. group classification was predicted by partial-least-squares discriminant analysis. gene targets and causal networks were identified by ingenuity pathway analysis. results: differential gene expression analysis revealed significantly regulated mirnas in pneumonia compared to volunteers, and mirnas in pneumonia related to sepsis. based on sparse-partial least discriminant analysis, group separation was achieved by mirnas as discriminators with high sensitivity and specificity (area under the curve of the receiver operated curve: volunteer: . , pneumonia: . , sepsis: . ). mir- a- p (log fc = . , padj = . e- ) and mir- - p (log fc = . , padj = . e- ) differentiated between pneumonia and volunteers and mir- (log fc = − . , padj = . e- ) between pneumonia and sepsis. expression levels of mir- a- p and mir- were related to disease severity. mir- - p was higher expressed in pneumonia compared to volunteers and had equal expression in patient groups. prediction of group classification in the testing cohort was . %. signalling networks were constructed for "cellular and humoral immune response", "antimicrobial response" and "pathogen influenced signaling" involving the significantly regulated mirnas. summary/conclusion: crude ev mirnas are potentially novel biomarkers for community-acquired pneumonia and may help to identify patients at risk for progress to sepsis allowing early intervention and treatment. introduction: it remains unclear the specific mechanisms that lead to airways inflammation in asthma and the subsequent remodelling of the airways. exosomes, small extracellular vesicles, has become in an important mechanism of cell-to-cell communication and participate in diverse biological processes including inflammation. in this study, we hypothesize that exosomes and their mirna cargo play an important role in the proinflammatory status of the upper airway of asthma patients, especially in those patients with severe asthma. methods: in a pilot study, healthy subjects had induced sputum using standard methods. after several centrifugation steps, we were able to isolate exosomes from sputum supernatant by both precipitation and size exclusion cromatography (sec). exosome size was observed with transmission electron microscopy (tem) and the protein markers cd and cd were analysed by western blot (wb). then, total rnas were isolated from sputum exosomes and mirnas (mir- a-p, mir- - p, mir- a, mir- b- p, mir- - p, mir- - p, mir- - p, mir- - p, let- g- p) , were evaluated by rt-qpcr. after the optimization of the methodology, healthy adults subjects and patients with persistent moderatesevere asthma, matched by age and sex were selected and induced sputum was collected. results: exosomes isolated with both methodologies (precipitation and sec) were observe under the tem with a correct range of size. furthermore, wb assay displayed a coherent protein profile for the exosome markers cd and cd . however, sec displayed low signal and the variability of between subjects was to higher. using the optimized method of precipitation, we observed that after normalization, mirna- a showed a significant increased (p = . ) in asthma patients compared to control. this mirna has been linked with an active proinflammatory status. summary/conclusion: our results confirm the presence of exosomes in induced sputum with promising applications in the field of asthma. the upregulation of exosomal mir- a, which is related with inflammation, suggest that exosomes could play a crucial role in the chronic inflammation of airway described in asthma patients. human nrf -active multipotent stromal cell exosomes reverse pathologic delay in the healing of cutaneous diabetic wounds joseph kuhn a , absara hassan b , sonali sharma b , jennifer kwong b , montaha rahman b , salma adam b , jasmine lee b , alvaro villarreal ponce b and piul rabbani b a nyu langone health, new york, usa; b nyu langone health, new york, usa introduction: multipotent stromal cells (mscs) have attracted much attention for their capacity to accelerate wound healing. exosomes, nanosized extracellular vesicles, may be key to translating msc therapy. we previously found that nuclear factor erythroid -related factor (nrf ) regulates msc promotion of diabetic tissue repair. here, we explore a novel role of nrf in exosome biogenesis and investigate whether exosome treatment recapitulates the effects mscs have on healing. methods: exosomes were harvested by differential ultracentrifugation of conditioned bone marrow derived msc media. for nrf -active exosomes, mscs were incubated with potent nrf activator, cddo-im. exosomes and mscs were vigorously characterized. full-thickness humanized-stented wounds were created on adult leprdb/db diabetic mice (db/db). exosomes were injected intradermally and circumferentially to the wound margin. results: mscs adopt an adherent fibroblast morphology, demonstrate robust osteogenic, chondrogenic, and adipogenic differentiation, express > % positive msc markers (cd , cd , cd , and cd ) and < % express negative markers (cd , cd , cd , cd , or hla-dr). immunoblotting of msc exosomes shows enrichment for positive exosomal markers cd , cd and tsg . nanoparticle tracking analysis (nta) shows a nanoparticle population with mean diameter of . ± . nm. transmission electron microscopy of exosomes reveals flattened cup-like spheres. nta demonstrates that nrf -active human mscs increase exosome secretion by %, compared to nrf -baseline mscs (p < . ). both nrf -baseline and nrf -active exosome treatment significantly reduced closure time to . and days respectively, compared to . days for vehicle-treated wounds (p < . ). this reduction eliminated the delay in closure time compared to wounds of c /b mice. nrf -active exosome treatment of db/db wounds reduced closure time by a further . days compared to untreated c /b wounds. at day , exosometreated db/db wounds have significant decreases in epithelial gap, expanded granulation tissue, and greater density of cd + vessels compared to vehicle-treated wounds. introduction: obesity increases prostate cancer aggressiveness and adipose tissue (at) is a rich source of extracellular vesicles (ev) that have been shown to contribute to pro-oncogenic effects in various malignancies. twist is a key mediator of tumour cell metastasis.. the goal of this study was to determine molecular and phenotypic changes of prostate cancer cells in response to evs from obese human at and the role of different levels of endogenous twist . methods: ev were harvested from human at (atev) obtained from bariatric subjects or from at endothelial cells treated with proinflammatory cytokines (pic-ev) to mimic the obese at environment. evs were isolated by ultracentrifugation and characterized by electron microscopy, nta and protein markers. we determined the effect of atev and pic-ev on pc -ml prostate cancer cells proliferation and invasion. ev mirna cargo and transcriptome of pc -ml cells treated with atev or pic-ev were assessed using nanostring. to establish the contribution of twist to the ev-related phenotypic and molecular changes in recipient cells, we used pc -ml lines stably overexpressing or deficient in twist . results: atev from obese subjects and ev-pic from at endothelial cells both reduced invasion and increased proliferation in wild-type pc -ml cells. a molecular signature showing decreased expression of genes mediating invasion, adhesion and metabolism supported these functional effects. also atev and ev-pic shared a subset of mirna that target multiple mmps, inhibit glycolytic genes and target cell cycle inhibitory genes. pc -ml overexpressing twist showed an increase in both proliferation and invasiveness and this phenotype was supported by the transcriptomic analysis following ev treatment. summary/conclusion: ev produced by obese at or by at endothelial cells share a subset of mirna that in conjunction with increased twist expression contribute to tumorigenesis and metastasis of prostate cancer cells in vitro. funding: american heart association of symposium introduction: as researchers continue to explore the therapeutic potentials of extracellular vesicles (evs) for the treatment of many diseases, there is a growing unmet need for real-time in vivo monitoring of these therapeutic evs after they are injected into a subject to understand their safety, targeting, and effectiveness. while current optical imaging solutions like bioluminescence and fluorescence are useful for ev tracking studies in animal models, there is limited utility in clinical applications. here we present a novel ev tracking solution utilizing clinically applicable mri technology. methods: to generate trackable evs, cells were labelled with a clinically applicable novel magnetic agent. evs secreted by the labelled neural stem cells and amniotic fluid stem cells (afscs) were isolated by differential ultracentrifugation. the viability and morphology of labelled-cells were evaluated, and the in vitro mr properties of their derived evs were analysed by magnetometer. a proof of concept in vivo biodistribution study was conducted by injecting labelled evs into wt and alport mice (a model of chronic kidney disease) via retro-orbital and intra-cardiac routes and tracking them via mri at min and hr postinjection. results: the magnetic label did not affect the physiological characteristics of the cells. the mr detectability of labelled-evs was confirmed by in vitro/ex vivo mri phantoms. mri studies showed that homing of afsc evs to the kidney injected intra-cardiacally into alport mice were more efficient versus the retro-orbital route, and prussian blue staining of kidney sections confirmed the mr findings. introduction: a central question in ev biology is the fate of circulating ev. this can be evaluated by developing non-invasive ev bioimaging techniques in mice in order to benefit from transgenic and knock-out models. recent reports described ev biodistribution in vivo using optical (fluorescence) and nuclear imaging. but the physicochemical properties of the probes impact ev integrity, labelling efficiency, background signals and observation timecourse. methods: we developed the radiolabeling of red blood cells (rbc) and ev with [ f]fluorodeoxyglucose ( f-fdg). we used rbc-derived ev in their native, intact form, without pre-experimental processing (no centrifugation or filtration). we tracked f-fdg in vivo by pet-scan, within seconds of ev, rbc or free f-fdg injection, and during their dissemination in blood and recruitment by organs over one hour. ev and rbc biodistribution were confronted to the kinetics of free f-fdg. results: we collected images of the biodistribution of rbc, and rbc-derived ev. nuclear imaging was well suited for accurate studies of ev organotropism, with high sensitivity, excellent signal-to-noise ratio, very low signal absorption by tissues and an inherent quantitative tomographic nature. ev-specific signals were mostly accumulated within minutes of injection (tail vein), in the spleen and liver, with a small part in the bone marrow (femurs). signals in other compartments were largely transient and linked to tissue perfusion and blood volume. we selected the most drastic control conditions to secure a correct interpretation of the data. this made kidneys, hearts and brains unavailable for analysis. hence the new approach came with limitations, but we describe how "free" f-fdg signals can be used to draw sound conclusions for ev. summary/conclusion: we propose that three types of compartments coexist in control mice at rest: active ev-capturing organs with high capacity and specificity including the spleen, and to a lesser degree the bone marrow; passive ev-retaining organs with high capacity, including the liver; and ev-neutral organs where transient signals only mirror tissue perfusion. we also report how ev biodistribution patterns are altered in ageing animals, as an example. we hope that this novel, non-invasive, quantitative, dynamic wholebody imaging approach will help characterize native cell-derived ev and help set standards for the reproducibility of ev bioimaging in mice. funding: frm grant "biface", inserm copoc, cnrs. introduction: extracellular vesicles (ev) are important mediators of intercellular communication; however, basic principles of ev biogenesis and loading remain largely unknown. a limited repertoire of tools has thus far made these processes challenging to research. the development of an ev-transfer reporter in a genetically tractable organism such as drosophila has allowed us to study mechanisms of cargo loading in vivo and has provided us with a platform to explore fundamental aspects of ev biology. methods: we have developed a bioinformatic pipeline to analyse the properties embedded in the ʹutr of mrnas enriched in evs released by drosophila cells. in parallel, we have adapted a cre-loxp system for use in fruit flies that appears to be proficient to reveal the exchange of bioactive molecules between secretory and recipient cells. results: taking advantage of computational methods, we uncovered sequence motifs that preferentially appear in combinations along the ʹutr. these sequence motifs occur within characteristic secondary structures, in a way that is more variable and motif dependent than previously reported. identified motifs also show similarities to known binding sites for rna binding proteins; a feature potentially important for ev-loading. in parallel, we developed a drosophila in vivo system to detect cell communication in complex tissues and between different cell types. using this system, we studied the biological significance of specific sequence motifs and identified their ability to modulate mrna ev-transfer in a context dependent and evolutionarily conserved manner. summary/conclusion: in summary, we have developed a novel tool to study cell communication in complex tissues, and shown its effectiveness to study principles of ev biogenesis and loading. beyond improving our understanding of ev biology and providing a novel tool to the scientific community, we hope this knowledge will pave the way to harnessing evs as a means of remotely manipulating cell communication in many biological contexts. introduction: the idea of cross-kingdom, species and inter-individual transfer of bioactive compounds via extracellular vesicles (evs) is a recent avenue. however, the bioactivity and bioavailability of these dietary compounds upon consumption is highly debated. it has been proposed that evs from diet can absorbed by consuming organisms, be bioavailable in various organs and exert phenotypic changes. milk is the most vastly consumed beverage and is an abundant source of evs that may act as signalosomes. whether these milk-derived evs can serve as cross-species messengers and have a biological effect on host organism has been poorly understood. methods: bovine milk-derived evs were isolated by ultracentrifugation and optiprep density gradient centrifugation. the evs were characterised by tem, nta, quantitative proteomics and rna-seq. evs were orally administered to various mice models of colorectal, breast and pancreatic cancer. primary tumour burden was monitored, and the rate of metastases was measured by imaging and qpcr. immune cells were analysed by facs. mechanistic insights were obtained using quantitative proteomics, confocal microscopy and biochemical experiments. results: we demonstrated that upon oral administration, bovine milk-derived evs were able to survive the harsh degrading conditions of the gut and be bioavailable in peripheral tissues. interestingly, oral administration of milk-derived evs reduced the primary tumour burden in various cancer models and attenuated cancer cachexia. intriguingly, despite the reduction in primary tumour growth, milk-derived evs accelerated metastasis in breast and pancreatic cancer mice models. timing of ev administration was critical as oral administration after resection of the primary tumour reversed the pro-metastatic effects of milkderived evs in breast cancer. biochemical and quantitative proteomics analysis highlighted the induction of epithelial-to-mesenchymal transition and senescence upon treatment with milk-derived evs. summary/conclusion: taken together, we were able to demonstrate the capacity of bovine milk-derived evs in mediating cross-species communication and regulating cancer progression in a context-dependent manner. bacterial membrane vesicles (mvs)a bacterial innate defence system against viral infection xiaomei yan, qian niu and ye tian xiamen university, xiamen, china (people's republic) introduction: in order to survive the constant onslaught of phage, bacteria have evolved diverse defence mechanisms that act at every stage of the phage life cycle. it has been suggested that bacterial membrane vesicles (mvs) may play a key role in innate bacterial defence against phage infection by acting as a decoy to prevent phage adsorption. nearly a decade has passed since mvs were first proposed as a decoy, but details of how bacteria utilize mvs to defend against phages remain poorly understood. here we use the laboratory-built nano-flow cytometer (nfcm) to reveal details of the interaction between mvs and phages at the single-particle level, and to provide new insights into innate defence mechanisms of mvs. methods: s. typhimurium was used as the model system. differential ultracentrifugation and density gradient centrifugation were used to isolate and purify mvs and bacteriophage p . cryo-tem was used to determine the morphologies of mvs and phage p . the purity of mv isolates was validated by measuring the particle concentration before and after triton x- treatment. monodisperse silica nanoparticles were used as the size reference standards to measure the size distribution of mvs via single-particle light scattering detection. the purity of phage p was verified by concurrent detection of side scatter and fluorescence signals of single phages upon nucleic acid staining by syto . results: by incubating mvs and af -labelled p , the number of phages adsorbed on single mvs were accurately quantified. we found that s. typhimurium and mvs it secretes express different affinity for phage p attachment. the binding ability of p to mvs is greater than that of bacteria. we confirmed that p can inject their nucleic acids into mvs, and these nucleic acids can be degraded by non-specific nucleases inside mvs for the first time. besides, by labelling the nucleic acids of mvs with syto , we were able to distinguish three different subpopulations of mvs. summary/conclusion: taking advantage of the superior sensitivity of nfcm in single-particle analysis, we developed a novel approach to the characterization of the interaction between mvs and phages. our study revealed that bacteria produce mvs as bait to attract viral adsorption and nucleic acids injection. funding: this research was supported by the national natural science foundation of china (grants , and ). introduction: the development of evs for therapeutic applications requires an in-depth understanding of their in vivo biodistribution and pharmacokinetic profile. in this study, we have made a comprehensive comparison of nuclear, fluorescent, and bioluminescent imaging technologies to identify the most suitable in vivo ev tracking method. methods: evs were purified from expi f cell supernatant by differential centrifugation followed by iodixanol density gradient separation and further characterized following misev guidelines. engineered expi f cells were used to generate evs carrying mcherry or nanoluc (nluc) proteins. the membrane of naïve ev was labelled with indium (in )-dtpa or xenolight dir post-ev isolation. ct tumour-bearing balb/c mice were intravenously dosed with × evs followed by imaging at h, h and h using spec/ct and ivis systems. tissue distribution and blood circulation profile of evs were analysed from ex vivo samples up to h post-injection. results: xenolight dir and (in )-dtpa were the most suitable ev labels for live whole-body animal imaging, ex vivo organ imaging, and tissue lysate quantification. nluc was appropriate for ex vivo imaging and tissue lysates quantification, but suboptimal for live imaging with limited sensitivity. mcherry evs were found not suitable for in vivo tracking studies due to high background signal fluorescence. ex vivo organ quantification of in -dtpa and dir showed that naïve evs mainly accumulate in liver, followed by spleen, kidneys, and lungs at h post-dose, with less than % ev exposure to the tumours. interestingly, nluc-evs accumulated mainly in the lungs, regardless of the small size of the particles injected and the absence of aggregation. blood circulation profile of in -dtpa and nluc evs showed rapid clearance of vesicles from circulation, with % of injected dose detected in blood after min and less than % after h. summary/conclusion: radionuclide imaging is an excellent technology to detect evs in vivo and ex vivo with high resolution and sensitivity but requires advanced infrastructure for radiolabeling. the optical methods have limited tissue penetration and sensitivity but can be improved with the right selection of the dye. these results contribute to the understanding of the biodistribution and pharmacokinetics of evs and are highly relevant to exploiting their potential for targeted delivery to diseased tissues in vivo. symposium introduction: new methods for quantifying extracellular vesicles (evs) in complex biofluids are critically needed. we report the development of a new technology combining size exclusion chromatography (sec), a commonly used ev purification technique, with fluorescence detection of specifically labelled evs (flu-sec). methods: flu-sec was validated using red blood cell derived evs (revs). size and concentration measurements were performed by microfluidic resistive pulse sensing (mrps) using the ncs instrument (spectradyne llc, usa). pe-cd a (anti-glycophorin a) and alexa -wga (wheat germ agglutinin) were used to label revs. flu-sec experiments were performed on a liquid chromatography system using a tricorn / glass column filled with sepharose cl- b gel (ge healthcare). results: a log-normal size distribution was obtained for revs with a mean diameter of . ± . nm and standard deviation of . ± . nm. the concentration of revs measured by mrps was . * e particles/ ml. the fluorescence chromatograms of the rev samples labelled with pe-cd a and with alexa -wga show the typical features of the separation of evs from soluble proteins with sec and enables the determination of the labelling efficiency of the markers. the linear range for quantification of evs in our experiments spans over two orders of magnitude ranging from e particles/ml to e particles/ml. the lod depends on the type of the label. in our experiments the lowest lod was e particles/ml for alexa -wga. summary/conclusion: the results indicate that flu-sec is a quantitative technique with very good linearity over a wide range of concentrations, though the limit of detection depends largely on the employed label (sci. rep. , , ) . moreover, the ratio of ev-bound and free-antibody molecules can be also determined by flu-sec, which can be used to calculate the labelling efficiency of the used marker. funding: this work was supported by the national research, development and innovation office (hungary) under grant numbers pd and nvkp_ - - - . zv was supported by the janos bolyai research fellowship. the conan assay: purity grade and concentration of ev microlitre formulations by colloidal nanoplasmonics. (evs). control over such properties is constantly experienced by researchers to be critical for ev proper manipulation, engineering and translation. however, the need for characterization methods that strike the balance between robustness, working volume, cost and accessibility remains unmet. methods: the colorimetric nanoplasmonic (conan) assay we developed consists of a solution of gold nanoparticles (aunps) into which - μl of the ev formulation is added. the solution turns blue if the formulation is pure, while stays red if soluble exogenous single and aggregated proteins (saps) are present. the colour shift is visible by the naked eye and can be quantified by conventional uv-vis spectroscopy, providing a quantitative index of purity and an estimation the ev molar concentration (particle number). results: the assay specifically targets saps, and not the ev-related proteins, with a detection limit < ng/μl (an order of magnitude higher resolution than the bradford protein assay). for pure solutions, the assay also allows for determining the ev number, as the colour shift is linearly dependent to the aunp/ev molar ratio. instead, it automatically reports if the solution bears sap contaminants, thus avoiding counting artefacts. experiments, conducted on ev separated from milk and ascaris suum culture medium, are repeatable, with an error below %. summary/conclusion: conan proves to be robust and reliable, while displaying appealing performances in terms of cost (inexpensive reagents, run by standard microplate reader), working volumes ( - μl) and time (the procedure takes less than one hour). the ability to assign a quantitative purity grade is, up to date, a unique peculiarity of this assay. finally, the assay is potentially extendable to all classes of natural and artificial lipid micro-and nanoparticles. funding: evfoundry project, horizon -future and emerging technologies (h -fetopen), id: . marina cretich a , roberto frigerio b , alessandro strada b , greta bergamaschi b , marcella chiari c and alessandro gori c a consiglio nazionale delle ricerche (cnr), istituto di scienze e tecnologie chimiche (scitec), milano, italy; b consiglio nazionale delle ricerche (cnr); istituto di scienze e tecnologie chimiche (scitec), milano, italy; c consiglio nazionale delle ricerche (cnr); istituto di scienze e tecnologie chimiche (scitec), milano, italy introduction: small extracellular vesicles (sev) present fairly distinctive lipid membrane features in the extracellular environment. these include high curvature, lipid packing defects and a relative abundance in lipids such as phosphatidylserine and ceramide. sev membrane could be then considered as a "universal" marker, alternative or complementary to traditional characteristic surface-associated proteins. here we introduce the use of membrane sensing peptides as new, highly efficient ligands to directly integrate sev capturing and analysis on a microarray platform. methods: we designed and synthesized membranesensing peptide ligands as molecular baits for small ev and we demonstrate their use in a microarray platform as valuable alternative/complement to antibodies. evs from blood serum and plasma were isolated by ultracentrifugation, characterized by tem, nta, wb. samples were analysed by label-free, single particle counting and sizing on peptide microarrays coupled to fluorescence co-localization immune staining with fluorescent anti-cd /anti-cd /anti-cd antibodies. results: peptide microarrays were realized using a click-chemistry strategy for optimal peptide surface orientation and used to analyse evs from human blood. membrane sensing peptides showed a capturing capacity higher than anti-tetraspanin antibodies. in addition to purified vesicles, peptide ligands were tested with pure serum showing capacity to capture evs even from complex samples. in order to get insights into the ev-peptide binding mechanism and verify whether it is directly mediated by the lipid membrane, trypsin-treated evs were captured on peptide microarrays demonstrating that binding is not directly mediated by surface associated proteins. summary/conclusion: we introduced the use of membrane sensing peptides as a novel class of molecular ligands for integrated sev isolation and analysis, reporting for the first time on peptide microarrays for extracellular vesicles. given their affinity to the membrane of small ev, these molecules can serve as general baits, enabling vesicles capturing unbiased by differential surface protein expression. these new class of molecular probes may be integrated with the use of protein markers towards improved small ev isolation and characterization. compared to proteins and antibodies, peptides are characterized by low cost of preparation, remarkable stability and ease of chemical manipulation, offering virtually unlimited possibilities for experimental design. we anticipate that this new class of ligands, may greatly enrich the molecular toolbox for ev analysis. funding: hydrogex (regione lombardia&fondazione cariplo, grant n. - ) and index (european union's horizon research and innovation programme under grant agreement n° ) projects are acknowledged for partial financial support. high-resolution size-based profiling and morphological analysis of extracellular vesicles by scanning electron microscopy sara cavallaro a , federico pevere b , petra hååg c , kristina viktorsson c , rolf lewensohn c , jan linnros a and apurba dev b a kth royal institute of technology, stockholm, sweden; b uppsala university, uppsala, sweden; c karolinska institute, stockholm, sweden introduction: extracellular vesicles (evs) have been found to mediate intercellular communication in physiological and pathological processes. nevertheless, the understanding of evs bio-functionality remains elusive, mainly because of their high heterogeneity in molecular content, but also in size ( - nm) . therefore, accurate size measurements of evs are highly desired, particularly for exploiting their full diagnostic/therapeutic potential. currently available techniques, such as nanoparticle tracking analysis (nta), cannot accurately measure evs smaller than nm and are not capable to distinguish them from protein aggregates. on the contrary, electron microscopy (em) techniques allow high-resolution size-profiling and morphological analysis of evs over their whole size range. however, their low throughput combined with several long preparatory steps have prevented em from being routinely used for ev size profiling. methods: we shall present a method improvement in throughput and reproducibility of ev size-analysis by scanning em (sem). the technique is based on covalent ev capture onto a silicon wafer, using the protocol reported by cavallaro et al. up to the glutaraldehyde step. after immobilization, critical point drying (cpd) is performed to dehydrate evs before sem, while preserving their shapes. results: sem images, showing the comparison in densities of evs prepared by covalent and non-covalent coupling to substrate, indicated a good capture efficiency of our covalent protocol. the size distribution analysis showed good agreement between nta and sem for evs > nm. for smaller evs, sem is more sensitive than nta, thus more suitable to check the purity of ev-isolation techniques. last, atomic-force microscopy (afm) measurements was also used to validate our measurements. introduction: extracellular vesicles (evs) are membrane vesicles secreted into extracellular space, by almost all cellular populations, playing a major role in cell-to-cell communication. it has been already demonstrated that changes in luminal or surface protein cargos of these vesicles, may reflect the status of producing cells. for this reason, evs are considered as potential biomarkers in several types of diseases ranging from cancer diagnosis to heart rejection. periostin (postn) is a matricellular protein associated with evs, and its level is considered a possible biomarker, which indicate malignancy and poor clinical outcome in different types of cancer. here we extensively characterize the presence of postn associated on evs, showing how different isolation methods can drastically affect the amount of postn content in extracellular vesicles fraction. methods: serial ultracentrifugation steps or size exclusion chromatography were used to isolate evs from primary culture of cardiac progenitor cells. evs were characterize, according to misev guidelines, by western blot, nta, facs and cryotem analysis methods. postn amount, associated with evs, was analyses by western blot and elisa. furthermore, functional tests were performed on h c cardiomyoblast cell line, treated with the same amount of evs from different isolation methods; cells response were analysed by western blot. results: evs, from both the isolation methods, showed tsg , syntenin , cd positivity while grp was absent. nta showed no differences, in terms of amount and size of particles. by facs analysis evs resulted enriched with cd , cd and cd . cryotem showed a similar morphology in the two preparations with presence of protein contaminant in the ultracentrifuge pellet. in vitro, h c treated with evs showed activation of pfak after ʹ of treatment, this induction was . times higher in cells treated with evs isolated with ultracentrifuge compared to evs isolated with sec, confirming a drastic effect of postn protein contamination. furthermore, by phospholipase-c treatment, we found that postn is bound to evs surface through a gpi anchor. summary/conclusion: these results suggest that selection of a proper isolation method is critically relevant in evs studies, in particular when protein analysis is considered. different isolation methods dramatically influence protein amount in extracellular vesicles and consequentially their function. furthermore, in this study we show for the first time, that postn is actually bound to evs surface and not carried in their lumen as previously believed. members of the y-rna family have been detected in ev from various cell types and are among the most abundant non-coding rna types in plasma. we previously showed that shuttling of full-length y-rna into ev is modulated by tlr-activation of ev-producing immune cells. this suggested that y-rnas may have potential as biomarker for immune-related diseases. methods: we separated rna-containing structures in plasma based on differences in size, density, and resistance to protease/rnase treatment. using rt-qpcr, we quantified full-length y-rna subtypes (y , y , y ) in ev from various blood-related cell types cultured with or without lps-stimulation. inflammationinduced changes in y-rna were assessed in plasma samples from a human endotoxemia study. results: full-length y-rna in plasma was mainly found in ev (early sec-fractions, density . - . g/ml). in contrast, specific mirnas were either enriched in lpp (e.g. mir- ), in both ev and lpp (e.g. mir- and mir- ), or in ev (e.g. mir- ). evenclosed full-length y-rna was resistant to enzymatic degradation, while lpp-bound mirnas were degradation sensitive. we discovered that ev released by different blood cell types varied in y-rna subtype ratios. these ratios remained stable upon lps-stimulation of the ev-producing cells. in endotoxemia plasma samples, the neutrophil-specific y /y ratios and pbmcspecific y /y ratios changed significantly during systemic inflammation. importantly, the plasma y-rna ratios strongly correlated with the number and type of circulating immune cells during the inflammation process. summary/conclusion: cell type specific "y-rna signatures" in plasma ev can be determined without prior ev-enrichment, and may be further explored as biomarkers to diagnose inflammatory responses or other immune-related diseases. mining public ev small rna-seq data with mirev -insights into potential reference transcripts and abundant mirnas recently, extracellular membrane vesicle (mv) production has been proposed as a general secretion mechanism that could facilitate the delivery of functional bacterial nucleic acids into host cells. s. aureus produce membrane-bound, spherical, nano-sized, mvs packaged with a select array of bioactive macromolecules and they have been shown to play important roles in bacterial virulence and in immune modulation through the transmission of biologic signals to host cells. the present study sought to examine the nature of the association between nucleic acids and mvs produced by s. aureus. we also sought to analyse the immunostimulatory potential of mvassociated rna and dna, and to evaluate receptormediated recognition of mv-associated rna and dna molecules by innate immune cells. methods: by following a stringent purification protocol, we characterized the rna and dna content of mvs produced by actively growing s. aureus. nuclease protection assays were performed to determine whether mv-associated nucleic acids are protected from degradation. we assessed the immunomodulatory potential of mv-associated rna and dna by treating cultured mouse macrophages with mvs and measuring the induction of interferon-β mrna using qpcr. introduction: urinary extracellular vesicle (uev) transcriptome could potentially reflect the kidney gene expression profile and serve as virtual/liquid biopsy. in order to explore this possibility, we performed mrna sequencing of uevs from individuals with type diabetes to assess whether it can capture a "kidney enriched genes" expression signature that could lead to novel biomarker discovery for diabetic kidney disease. methods: the study included type diabetic individuals ( normoalbuminuric, microalbuminuric and macroalbuminuric). urine samples were collected either overnight (n = ) or during -hours (n = ) and uevs were isolated from - ml of urine by differential centrifugation. the evs quality was ensured by electron microscopy (em), western blotting and ev-rnasprofiling with the bioanalyzer. isolated rnas were subjected to rna sequencing after cdna library preparation (ultra-low amount protocols) using hiseq (illumina) pair-end protocol. the association between kidney specific gene expression levels (> fold higher compared to other tissues, n = ) and degree of albuminuria or glomerular filtration rate was explored. results: isolated ev quality appeared good by em and western blotting. rna quantity and quality were sufficient for sequencing of all samples with > million pair end reads. we detected on average expression of , genes. principal component analysis (pc) of the expression of all genes did not reveal any systematic batch differences between the overnight and -hour urine collections. comprehensive look-up of kidney-enriched genes revealed expression of > % (total ) of these genes in urine evs with high expression of five kidney-specific genes (slc a , slc a , nphs , aqp and slc a ). pc analysis combining the impact of kidney-enriched genes revealed that most macroalbuminuric patients clustered together along the pc axis, and the axis also correlated with the albumin-to-creatinine ratio (p = . ) explaining % of the variance (p = . ) in the whole data set. the pc axis also showed correlation with hba c (p = . ), but not with diabetes duration, bmi, age and egfr. introduction: due to their safety profile, tissue tropism and long-term transgene expression, adeno-associated viruses (aavs) have become the vector of choice for human gene therapy. however, pre-existing neutralizing antibodies (nabs) to many aav serotypes pose a critical challenge for the translation of gene therapies to clinic. here, we describe the use of exosomal aavs (eaav) as a robust cardiac gene delivery system that enhance transduction efficiency while shielding from pre-existing humoral immunity to the viral capsid. methods: we developed an ultracentrifugation-based purification strategy to obtain eaav specimens from aav-producing hek- t cells, and used electron microscopy-based visualization, confocal microscopybased colocalization studies, qpcr, immunoblotting, dynamic lights scattering, exoview technology and protease assays to characterize eaav morphology, contents and mechanism of action. we then evaluated efficiency of heart targeting for eaav or eaav and standard aav or aav encoding for egfp, mcherry or firefly luciferase in different human cell lines in vitro, in black mouse and in passive immunity nude mouse model in vivo using flow cytometry, confocal microscopy, langendorff perfusion system and methods: hlhs patients (n = ) after glenn procedure and swine (n = ) after pab were given rv injections of allogeneic/xenogeneic mscs. donor-specific, hla-i+, exosomes were isolated from plasma. in swine, exosomes were collected and rv fractional area change (fac) was measured post-msc-injection. in the elpis patients, exosomes were collected and outcome measurements (fac, stroke volume (sv), rv mass) were recorded and -months post-injection. exosomal mrna, microrna (mirna), and proteins were quantified and partial least squares regression (plsr) reduced the dimensionality of the datasets to build a swine model, upon which elpis outcome predictions were made. results: multiomics analysis of swine exosome cargo revealed mirna to be the largest contributor to overall variance. in swine and elpis patients, mirnas were similarly expressed ( %, fold-change< ). plsr reduced the dimensionality of the swine mirna dataset to mirnas with the highest weighted coefficients for changes in fac. pathway analysis of mirna targets revealed links to smooth muscle cell proliferation and cardiac chamber development. importantly, the swine mirna plsr model predicted elpis patient improvements in fac, sv, and rv mass with strong correlation (r > . ). summary/conclusion: these findings support the use of: ( ) swine pab model for rv failure in hlhs, ( ) circulating donor-specific msc-exosomal mirna as a novel, non-invasive biomarker of patient outcomes, and ( ) introduction: evs have been shown promising potential as a drug delivery vehicle, especially nucleic acid therapeutics. however, the overall short of specificity to target cancer cells has led to low therapeutic efficacy and potential toxicity. rna nanotechnology is the bottom-up self-assembly of nanometre-scale rna architectures. we previously discovered a stable phi prna three-way junction ( wj) motif and used it to construct multivalent rna nanoparticles with high chemical and thermodynamic stability. the resulting arrow-shape rna nanoparticles are homogenous, uniform in size and shape, and can harbour different functionalities while retaining their tertiary folding and independent functionalities both in vitro and in vivo. this flexible platform using rna nanotechnology to achieve tumour-specific targeting has been demonstrated over the last decade. here we introduce a strategy to take advantage of both evs and rna nanotechnology to develop a versatile platform for efficient target-specific delivery of sirnas for cancer treatment. methods: we design membrane-anchoring arrowtail wj rna nanoparticles to display tumour targeting ligand (psma rna aptamer or egfr rna aptamer or folate) on birc sirnas loaded evs (fig. ). nanoparticles were characterized by nanoparticles tracking analysis (nta), transmission electron microscopy (tem), dynamic light scattering (dls) and atomic force microscopy (afm). evs were produced by hollowfiber bioreactor and purify by tangential flow filtration (tff) follow by ultracentrifugation. cell binding were evaluated by flowcytometry and confocal microscopy and gene knockdown effect were assay by quantity reverse transcription-pcr (qrt-pcr). formulated evs were introduced to tumour (prostate, triple negative breast cancer, colon pdx) xenograft mice by tail-vein injection and evaluate in vivo tumour inhibition. results: ) we found the orientation of arrow-shaped rna can be used to control ligand display on evs membranes for specific cell targeting. ) by placing membrane-anchoring cholesterol at the tail of the arrow results in display of rna aptamer or folate on the outer surface of the evs and enhance cancer cell binding and uptake. ) taking advantage of the rna ligand for specific targeting and evs for efficient cytosolic delivery, the resulting ligand-displaying evs or plant derived evs-like nanovesicles were capable of specific delivery of sirna to cells, and efficiently blocked tumour growth in three cancer models. summary/conclusion: we developed an rna-evs based nanoparticles platform and shown the flexibility for different cancer type treatment. related publications: pi f et.al. nature nanotechnology. , : . li z et.al. sci rep. introduction: extracellular vesicles (evs) contain plasma membrane surface markers that provide insights into their cell source. until now, our understanding of the circulating ev-biome has been limited by the lack of celland size-specific ev quantitation methods. we have developed and validated a multiplex nanoscale flow cytometry approach to image cell-and size-specific ev populations using a novel human "ev-lyoplate" with differently coloured monoclonal antibodies per well in a well plate format (n = separate antibodies with isotype, stained pbs, unstained plasma, and quant-beads controls per plate). we hypothesized that platelet poor plasma samples from patients diagnosed with pancreatic cancer would have significantly different ev-biome profiles than screen negative study subjects. methods: study subjects were enrolled and sampled before clinically scheduled endoscopic ultrasoundguided biopsy (eus-fna) procedures to screen patients with symptoms of pancreatic duct obstruction who later had at least two years of clinical follow up, including surgical resection in cases of pancreatic neoplasia (n = ) or at least one follow up clinic visit to confirm resolution of symptoms. blood samples were uniformly collected, processed, and banked per isev recommended guidelines. uniform machine (facsymphony) settings to standardize light scatter and fluorescence detection were based on commercially available beads (eg. megamix). samples were coded and randomized for testing and results were reported as the mean cell-and size-specific ev events/ul of plasma. results: clinical outcomes confirmed cases of cancer and screen negative controls. principle component analysis suggested that a number of different celland size-specific evs were significantly more common in the cancer cases (adjusted p-value < . , with aucs > . ), including epcam+/cd + events likely from cancer cells and cd +/cd p+/cd + microvesicles from platelets, among others. summary/conclusion: in this proof of principle study employing an ev-lyoplate design and nanoscale flow cytometry, we could reliably discriminate the ev-biomes in patients with cancer from negative controls. ongoing studies will determine whether these discriminators will be validated in larger cohorts and provide at least noninferior predictive value compared with the current gold standard clinical testing assay (eus-fna introduction: small cell lung cancer (sclc) is an aggressive tumour type, usually metastatic at diagnostic leading to poor overall survival. interestingly, sclc tumours are composed by distinct subpopulations of cells that cooperate as an ecosystem to drive tumour survival. since the subtype of sclc may have prognostic significance, the aim of this study was to identify surface marker proteins as biomarkers of sclc. methods: a linear discriminant analysis (lda) model, implemented in python via sci-kit learn, was used to choose the best markers for distinguishing subtypes. this analysis was based on rna-seq data from a previous study. in order to identify ev-based biomarkers that would identify sclc evs and not normal evs, we excluded from this analysis proteins without a verified transmembrane domain and proteins associated with evs expected to be present in white and red blood cells, and endothelial cells (according to exocarta and vesiclepedia databases). we also prioritized proteins that could be pan markers for sclc and that might have prognostic significance. to validate our findings, we performed western blotting and flow cytometry in sclc cell lines from different subtypes. results: our rna analysis indicated that the best surface markers to distinguish sclc subtypes were ceacam , fam a, lrfn , epha . immunoblot analysis validated ceacam and epha but not fam a or lrfn . we also found that ncam , a commonly used sclc marker, only marks some of the subtypes. for further analysis, we chose proteins with antibodies validated for flow cytometry as our chosen biomarker platform. flow cytometry analysis of cd is suitable as a pan-sclc marker. however, the expression of non-ne cell lines was decreased compared to rna-seq data. summary/conclusion: protein analysis of ceacam and epha corresponded to rna-seq data. ncam was not detected as a pan marker for all sclc subtypes. however, we could see cd expression in all sclc subtypes, indicating it may be a useful pan marker for sclc. future studies will be performed to validate the expression of other surface markers in cells, purified evs, and plasma of sclc patients. funding: nih u ca and nih u ca . leukobiopsyexploiting extracellular vesicle-mediated leukocyte sequestration of cancer-specific signatures introduction: in cancer, extracellular vesicles (evs) act as a unique exit mechanism for mutant and oncogenic macromolecules (proteins, rna and dna) en route from malignant cells to blood . while this process has inspired major liquid biopsy efforts, the biology of circulating evs that carry oncogenic mutations (oncosomes) is still poorly characterized. it is also unclear what part (if any) of the tumour-related cell free dna (ctdna) , , a major liquid biopsy analyte, is linked to circulating evs and what is their fate, receptacles and biological activity. methods: we employed as series of cancer cell lines carrying mutations in major oncogenes (hras, her , egfrviii). ev-dna was analysed by digital droplet pcr (ddpcr), along with nuclear anomalies in donor cells (dapi, electron microscopy) and transfer of dna to recipient cells of endothelial (huvec, mmbec), astrocytic (nha) or myeloid (hl ) origin. blood underwent fractionation into red blood cells (rbc), white blood cells (wbc), platelets (plt), evs ( , g ultracentrifugation) and soluble plasma (sup) . results: hras-mediated cellular transformation (in ras- cells) triggers profound changes in the structure of nuclear chromatin, which is driven into the cytoplasm and released as cargo of evs. oncogenic dna is detectable in blood fractions of tumour bearing mice. while evs, ctdna and plts contain intermediate levels of mutant dna, rbcs contain only traces of this material. the highest hras copy number per ml of blood is found in wbcs (monocytes and neutrophils), which contain more cancer dna/cell than liver, spleen and bone marrow. depletion of neutrophils using anti-ly g antibody results in an increase in ev-and ctdna-associated mutant dna in blood, suggesting the role of these cells in regulating the circulating levels of cancer cell-derived particles. uptake of dna-containing evs impacts the phenotype of myeloid cells, which adopt thrombo-inflammatory properties. these cells also retain cancer-specific transcripts and other cargo. finally, normal astrocytes treated with oncogenic evs also exhibit phenotypic changes and signs of genomic instability including formation of micronuclei. summary/conclusion: we propose that the process of leukocyte sequestration of circulating particles containing tumour-related nucleic acids renders these cells potentially usable as a novel liquid biopsy platform (leukobiopsy) in cancer. introduction: early diagnosis of colorectal cancer (crc) and precancerous adenoma patients is of vital importance. previously we profiled small extracellular vesicles (sevs) derived mirnas isolated from plasma, proposed a new promising biomarker category of crc patients. here we further gave a full landscape of circulating sevs derived rnas to explore and evaluate sevs based rna biomarkers for early detection of both crc and adenoma patients. methods: plasma sevs were isolated from participants, including early-stage crc patients, adenoma patients, and normal controls (nc), and characterized according to misv guideline. the total sevs derived rna expression profile of all participants was investigated by next-generation sequencing (ngs). weighted gene coexpression network analysis (wgcna) was performed to categorize differentially expressed rnas, and t-distributed stochastic neighbour embedding (tsne) was adopted to distinguish crc, adenoma, from nc samples with the top-ranked genes in wgcna modules. rt-qpcr validation was performed in a cohort of additional participants. results: a total of rna species (including mirnas, mrnas, and lncrnas) were found differentially expressed between plasma sevs in crc and nc participants. additionally, rna species were differentially expressed between plasma sevs in adenoma and nc participants. rna species were differentially expressed between plasma sevs in crc and adenoma participants. wgcna categorized all rnas into modules, which exhibited different expression trends during the carcinogenesis of crc. a -gene combined tsne model consists of the top genes in each module could perfectly classify crc, adenoma, and nc samples. a -gene combined tsne model consists of the top gene in each module could roughly distinguish crc and adenoma from nc, with only sample misclassified. rt-qpcr assays also confirmed the potential classification ability of those genes in another validation cohort of participants. introduction: although the concept of systematic "liquid biopsy" using bodily fluids is simple and elegant, the path of clinical reality has been challenging. recently, numerous tissue-specific biomarkers have been discovered in evs derived from blood, urine, cerebrospinal fluid, cell culture media, and a variety of other fluids. however, tracing the lineage of evs to their tissue of origin remains challenging due to their minute amount of cargo and unavailability of matching biopsied tissue and bodily fluids from the same patient. we recently demonstrated in three separate publications (dogra et. al; smith et. al; murillo et. al) , a new device (nanodld) for ev isolations, it's comparison with current technologies, bioengineered vesicles, and a detailed study of rna types present in small/ large vesicles, lipoproteins, and ago protein in different biofluids. in the present study, we aim to investigate the lineage of prostate derived evs in biofluids. methods: using our chip technology, we have isolated exosomes from prostate cancer cell lines and patient tissue, blood and urine samples. after exosome isolation, small rna libraries were prepared, and sequencing is carried out at icahn school of medicine and new york genome center using illumine sequencer hiseq . our nanofluidic pillar array is manufactured in an sio mask using optical contact lithography and deep ultraviolet lithography. results: our study revealed i) rna markers, which are exclusive to their prostate tissue of origin and are secreted in evs; ii) approximately - % of prostate tissue-specific rna were discovered in evs; iii) over % ( of rna) of literature curated prostatespecific rna signatures were detectable in serum and urine evs from pca patients; iv) evs contained over - % of noncoding rna ( - % was mirna), while tissue predominantly yielded rrna (> %); v) finally, gene set analyses generated that over % of evs rna were enriched for signalling pathways, yielding mirna-associated, non-canonical wnt signalling, and androgen receptor pathways. this study enables us to noninvasively monitor prostate tissue-specific biomarkers, identify tumour-specific rna, and potentially may benefit in liquid biopsy by avoiding unnecessary surgical procedures. summary/conclusion: in summary, we have investigated patient matched tissue, serum, and urine derived evs in prostate cancer. we present a set of prostatic rna in evs, which are enriched in noncanonical wnt signalling, and androgen receptor pathways. this study enables us to noninvasively track prostatic biomarkers, identify tumour specific rna, and potentially may benefit in liquid biopsy by avoiding unnecessary surgical procedures. a multi-model, liquid biopsy approach for diagnosing and staging pancreatic adenocarcinoma introduction: pancreatic ductal adenocarcinoma (pdac) is the third largest contributor to cancerrelated death in the usa. since there is not yet a feasible technology to diagnose pdac early in the disease, % of patients are diagnosed at an advanced stage. moreover, for patients with confirmed pdac, standard imaging method has low sensitivity to detect early metastatic disease, which complicates the selection of therapy. to address these challenges, there has been great interest in developing minimally-invasive, extracellular vesicle (ev) based blood tests for pdac. to this end, we have integrated measurements of tumour derivedev rna cargo with circulating proteins and cell free dna (cfdna), and use machine learning algorithms to distill this multiplexed diagnostic to . diagnose pdac patients from healthy and disease controls and . distinguish pdac patients with distance sites of metastasis to guide their treatment. we make use of our lab's magnetic nanopore isolation technique to specifically enrich for tumour derived evs directly from patient plasma. methods: we have developed a high throughput nanofluidic sorting platform, which immunomagnetically isolates individual evs from plasma using magnetic nanostructures. however, our architectures is uniquely designed for massive parallelization allowing high throughput, robust processing of ml of plasma in minutes. we performed sequencing on a discovery set of patients and controls (n = ). subsequently, we trained our panel of biomarkers using a training set of n = . finally, we validated the performance of our platform using an independent blinded test set of n = . results: the results of a blinded test set achieved an accuracy = % and an auc = . on binary classification of pdac patients versus those that were healthy or disease controls. in addition, we achieved an auc = . and accuracy = % with sensitivity of % and specificity of % on detecting occult metastasist. summary/conclusion: we developed a highly sensitive pancreatic cancer diagnostics by combining our nanomagnetic isolation platform for tumourderived ev isolation, rna sequencing, and machine learning. we isolated tumour-derived evs and profiled their rna cargo, combined with cfdna and ca - for pancreatic cancer diagnosis. the predictive panels successfully distinguished non-cancer patients from pdac patients, and nodistant metastasis patients(m ) from distant metastasis patients(m ) for appropriate treatment. the resulting auc and accuracy from the independent blinded test set outperformed any individual biomarker, showing both the benefits and the robustness of combining multiple orthogonal biomarkers for pdac diagnosis. introduction: both hypertension and diabetes exhibit significant molecular changes to the vasculature that are associated with increased cardiovascular risk. here we examined the protein composition of large evs (l-evs) isolated from the plasma of hypertensive, diabetic and healthy mice to identify common and diseasespecific molecular changes. methods: we examined circulating l-evs isolated from transgenic mice expressing active human renin in the liver (ttrhren, a model of hypertension), ove type diabetic mice, and their wild-type (wt) littermates. at weeks of age mice were sacrificed and blood samples were obtained by cardiac puncture. l-evs were isolated from platelet-free plasma via differential centrifugation and protein content was assessed via mass spectrometry (ms). results: ttrhren mice exhibited increased blood pressure compared with ove mice or their wt littermates. ( . ± . vs . ± . [ove ] vs. . ± . mmhg [wt], p < . ). ms identified independent proteins with at least peptides per protein. of these, proteins were found in all groups studied, were exclusive to wt mice, were exclusive to ove mice and were exclusive to ttrhren mice. in addition, proteins were observed with > . fold change (fc) compared to wild-type mice, and proteins were reduced by > %. amongst the top ten differentially expressed proteins, fibrinogen was upregulated in both ove and ttrhren mice compared with wild-type controls. similarly trem-like transcript , sarcoplasmic/endoplasmic reticulum calcium atpase and junction plakoglobin were all downregulated in both ove mice and ttrhren mice suggesting molecular changes common to both conditions. conversely, arginase was up-regulated in diabetic, but not hypertensive mice while carboxypeptidase was upregulated in hypertensive but not diabetic mice. summary/conclusion: taken together, these results show that the protein composition of circulating l-evs is altered in diabetes and hypertension and that both common and disease-specific changes may be detected. further analysis of these changes may lead to the identification of novel pathways associated with the pathogenesis of vascular injury in hypertension and diabetes. funding: this study was supported by grants (to db) from the canadian institutes of health research, an ontario early researcher award, and the canada foundation for innovation. understanding the role of endothelial cell-derived apoptotic bodies in inflammatory signalling and cell clearance in an atherosclerosis model of inflammation. introduction: apoptotic bodies (apobds) are a class of large (~ - um) evs formed during apoptotic cell disassembly, that are becoming increasingly recognized as potential mediators of intercellular communication, e.g. via the transfer of proteins and other cargoes to target cells. during the inflammatory vascular disease atherosclerosis, endothelial cell (ec) apoptosis contributes to loss of barrier function and promotes the formation of plaques in regions of ec damage. although, experimentally, ecs generate an abundance of apobds, a specific role for ec-derived apobds (ec-apobds) in the progression of atherosclerosis remains poorly defined. methods: in the present study, a detailed in vitro characterization of ec disassembly was performed via flow cytometry, confocal live cell imaging and cytokine profiling, followed by function analyses of ec-apobds using a murine in vivo model of dead cell clearance. results: characterization of ec disassembly revealed that apobd formation in ecs is regulated by rho-associated, coiled-coil-containing protein kinase (rock ), a process that can be pharmacologically inhibited using a rock- inhibitor, thereby providing tools for functional in vivo studies. the specific cargo and role in clearance of ec-apobds were then investigated. profiling of ec-apobds was performed via cytokine antibody array to reveal that ec-apobds generated under inflammatory conditions contain high levels of pro-inflammatory cytokines including mcp- and il- , suggesting a potential role for ec-apobds in the propagation of inflammation during vascular disease. furthermore, the ability of ec-apobds to be cleared from the vasculature via phagocytosis was investigated, revealing that ec-apobds can travel to distal organs to undergo clearance. summary/conclusion: these findings provide important insights into the potential functions of ec-apobds generated under both non-inflammatory and inflammatory conditions and may contribute to future studies involving the therapeutic targeting of ec disassembly for the treatment of atherosclerosis. funding: this work was supported by grants from the national health & medical research council of australia (gnt , gnt ) adipose mesenchymal stromal cell derived evs foster cardio-renal protection in the doca-salt hypertensive rat model introduction: cardio-renal syndromes (crs) are disorders of the heart and kidneys whereby "acute or chronic dysfunction in one organ may induce dysfunction of the other". stem cell-derived extracellular vesicles (evs) mediates the protection of the kidney from development of chronic kidney disease (ckd). we here investigated the potential of adipose-mesenchymal stromal cells derived evs (asc-evs) as therapeutic tools for the treatment of crs. methods: adult wistar rats were uninephrectomized and treated with a high-na+ diet and deoxycorticosterone-acetate (doca-salt) for -weeks ( / ; a / - - ). evs were isolated by ultracentrifugation method. ev dimension, concentration and surface markers were characterized by nta, cytofluorimetric analysis and transmission electron microscopy. to characterize the role of evs in crs, doca-salt rats were injected weekly with asc-evs. systolic blood pressure was measured by the tail-cuff method. plasma creatinine and urinary protein excretion were determined by colorimetric assays and microalbuminuria by immune turbidimetric assay. qrt-pcr and western blot were conducted to evaluate fibrosis and inflammatory-related genes and proteins in the kidney and heart of doca-salt rats. immunohistochemistry was used to confirm matrix accumulation (a-sma) and immune infiltrate (cd + cells). results: multiple administration of asc-evs in doca-salt rats induced a protective effect on the kidney, by reducing tubular and vascular damage. kidney function was also conserved by ev treatment as detected by the normal glomerular filtration rate and the absence of proteinuria with respect to doca-salt untreated rats. ev administration significantly decreases the pro-inflammatory molecules mcp- and pai and reduce the recruitment of macrophages in the kidney. the mitigation of the inflammatory response by asc-ev infusion consequentially affected the development of fibrosis, as detected by the decrease in collagens (col a , col a ) and fibronectin (fn) expression in respect to doca-salt animals. asc-evs were able to act in multiple organs, preventing fibrosis and inflammation also in the heart, therefore alleviating blood pressure rise during the -weeks of treatment in doca-salt rats. summary/conclusion: our results indicate that asc-ev administrations in hypertensive-induced ckd rats promote protection from renal damage, reduction of the inflammatory response and prevention of interstitial fibrosis in the kidney. asc-evs are also able to protect the cardiac tissue and to control blood pressure increase, displaying complex and multiorgan beneficial effects. introduction: alveolar macrophages (ams) tonically secrete extracellular vesicles (evs) containing suppressor of cytokine signalling (socs ) protein. uptake of socs -containing evs by alveolar epithelial cells is critical for restraint of cytokine-induced janus kinasesignal transducer and activator of transcription (jak-stat ) signalling to promote homoeostasis in the distal lung. at steady state, ams exhibit suppressed glycolytic activity, a metabolic phenotype that promotes homoeostatic function. whether this glycolytic restraint is critical for am secretion of socs is unknown. in fact, to our knowledge, metabolic control over release of any ev cargo has never been explored in any cellular context. methods: immortalized mouse ams (mh-s) were treated with various doses of -deoxy-d-glucose ( -dg) and oligomycin, inhibitors of glycolysis and oxidative phosphorylation, respectively. primary rat ams collected by lung lavage were treated with an aqueous extract of cigarette smoke (cse) with or without -dg. metabolic activity was measured by seahorse assay, evs were quantified by nanoparticle tracking analysis, and vesicular (> -kda) socs secretion was determined by western blot of conditioned medium. additionally, ams collected from wild-type (wt) and lsl-krasg d mice bearing lung tumours weeks after intrapulmonary ad-cre were cultured ex vivo in the presence or absence of -dg. vesicular (> -kda) socs secretion was measured by elisa. results: in a dose-dependent manner, oligomycin inhibited, whereas -dg enhanced, socs and ev release by mh-s cells. treatment of rat ams with cse ( %) attenuated secretion of socs , an effect that coincided with increases in glycolytic activity, and co-treatment of ams with -dg abrogated the inhibitory effect of cse on socs release. finally, ams collected from lsl-krasg d mice exhibited a deficiency in socs secretion relative to wt ams, an effect that was reversible by overnight culture in the presence of -dg. summary/conclusion: in tandem, our data generated using in vitro and in vivo approaches demonstrate that am secretion of vesicular socs is down-regulated by glycolysis. we speculate that metabolic control over release of ev cargoes is a phenomenon of broad biologic relevance within and outside of the lung. introduction: bacterial extracellular vesicles (ev) are described to play roles in defence and resistance, pathogenesis and stress responses. cyanobacteria pioneered oxygenic photosynthesis, and are the ancestors of modern chloroplasts. we previously described that by deleting the gene encoding tolc (Δtolc) in the model cyanobacterium synechocystis sp pcc (s ), a key player in protein-mediated secretion systems, a hyper-vesiculating phenotype could be obtained. the goal of this work was to understand why Δtolc hyper-vesiculates. methods: isobaric tag for relative and absolute quantitation (itraq) was used for quantitative proteomic analyses of total cell extracts. ev were isolated as follows: cells were separated from the extracellular medium (em) by centrifugation ( g, min) and filtration ( . µm pore-size filters). cell-free em was concentrated using centrifugal filters (mwco of kda), and later ultracentrifuged for h at g. the final ev fraction was suspended in growth medium. ev characterization was performed using tem, dls, nanosight, and by the detection and quantification of lps (lipopolysaccharides). detection of specific proteins in ev was carried out by western blot. copper (cu) levels were quantified by atomic absorption spectrometry (aas). results: a large-scale quantitative proteomic analysis was performed, resulting in the identification of several metal-related proteins with differential regulation in s Δtolc. both wild-type (wt) and Δtolc cells were then challenged with different metals. compared to the wt, Δtolc showed impaired growth only when exposed to cu, a co-factor for several proteins with roles in primary metabolism. the intracellular cu levels were quantified and Δtolc accumulates threefold more cu than wt cells. we then asked whether the hyper-vesiculating phenotype observed could be linked to the stress induced by cu accumulation. in ev isolated from Δtolc we detected the metallochaperone copm, a periplasmic cu-binding protein involved in cu-resistance mechanisms in s . in addition, cu could also be detected in isolated Δtolc-ev. in addition, more ev were detected when s wt cells were challenged with cu, in a cu-concentration dependent manner. summary/conclusion: these results support the idea that bacterial ev represent an alternative cu-secretion mechanism to deal with cu-induced stress. funding: fct phd grant sfrh/bd/ / ; feder-compete -poci-fct project: poci- - -feder- . juan wang and maureen barr rutgers university, human genetics institute of nj, piscataway, usa introduction: extracellular vesicles (evs) function in intercellular communication. despite their physiological importance and biomedical relevance, knowledge of ev fundamental biology is not well understood, in part due to a lack of tractable animal systems. our analysis of environmentally-released c. elegans ciliary evs provides strong evidence that nematodes package cargo in evs that mediate inter-organismal communication, in analogy to intercellular signalling in mammals. we predict that conserved mechanisms underlie ev cargo sorting, biogenesis and signalling. cilia act as cell towers to both receive extracellular signals and to send information via ciliary evs. ciliary defects result in human ciliopathies including autosomal dominant polycystic kidney disease (adpkd). adpkd is a life-threatening disease that affects / and is caused by mutations in pkd and pkd , which encode polycystin- and − . in c. elegans and humans, the polycystins are architecturally similar, act in the same genetic pathway, function in a sensory capacity, localize to cilia, and are shed in evs, suggesting ancient conservation. moreover, ciliary ev biogenesis and shedding is an evolutionary conserved process from algae to worms to humans. by studying how cilia make and receive evs, we aim to uncover fundamental principles of how cells communicate using evs. methods: to study ciliary ev cargo sorting and biogenesis, we use genetically-encoded fluorescent-tagged ev cargo and superresolution zeiss airyscan confocal microscopy in living animals. results: we find that cargoes are sorted into distinct populations. in cilia, kinesin- motors and kinesin- klp- /kif transport different ev cargoes to the ciliary tip and generate an ev cargo enrichment zone. from here, evs are shed and released into environment in a spatially and temporally regulated manner. ciliary ev biogenesis and release is regulated by mechanical pressure and ph. our work revealsat the single cell levelthat different evs are made in response to environmental stimuli, which may be important for ev signalling properties. summary/conclusion: cells exploit the spatiallyrestricted cilium and its sophisticated transport system to generate distinct populations of ciliary evs. how these ciliary ev communicate cellular messages awaits decoding. introduction: we recently demonstrated that recycling endosomes marked by rab a generate exosome subtypes distinct in cargos and functions from late endosomes, which we collectively term rab -exosomes. these exosomes are preferentially released from cancer cells in response to metabolic stress and promote adaptive changes in a xenograft model. here we use comparative ev proteomics in hct colorectal and hela cervical cancer cell lines to identify rab -exosome signature proteins and screen for functional effects. methods: we analysed ev preparations by mass spectrometry using tandem mass tag® labelling to identify changes in ev protein cargo in response to glutamine depletion. candidate genes were subsequently knocked down in drosophila secondary cells, which permit visualisation of rab -exosome biogenesis using fluorescence microscopy, and in human cancer cell lines. results: we show that accessory escrt-iii proteins, chmp , chmp and ist , are enriched on glutamine-depletion-induced evs and play a selective and conserved role in generating rab -exosomes. they are, however, not required to traffic ubiquitinated cargos into late endosomes and lysosomes. escrt- components, thought to regulate trafficking of ubiquitinated cargos into intraluminal vesicles, are also required to make rab -exosomes. in flies the escrt- , hrs, localises to the limiting membrane of rab -endosomes. comparative proteomics reveals other proteins enriched in rab -exosomes, which also appear to be needed to mediate this novel exosome formation mechanism. summary/conclusion: we conclude that rab -exosome subtypes are formed via a distinct mechanism requiring accessory escrt-iii components, suggesting a route to selectively target these exosomes. introduction: the tumour microenvironment consists of a complex network of host cells embedded within extracellular matrix. communication between these cellular compartments is critical for tumour progression and exosomes have emerged as important regulators of intercellular communication. while a number of studies have implicated exosomes in cancer progression, mechanisms controlling exosome transfer are not well understood. we developed three-dimensional ( d) culture models to evaluate the role of cues provided by the extracellular matrix in exosome release and uptake. methods: exosomes were isolated from cells in two-and three-dimensional culture via ultracentrifugation and characterized by nanosight, qubit protein quantification, and flow cytometry analysis of exosome markers. exosomes were labelled with fluorescent lipophilic dyes and uptake in recipient cells quantified by flow cytometry. results: cells cultured in d display decreased exosome release and increased uptake compared to d cultured cells. exosome release in d culture was inhibited with the exosome release inhibitors brefeldin a and gw , but was not significantly altered by knockout of rab b. in addition, disruption of polarity signals provided by d culture did not impact exosome release or uptake in d, but induction of oncogenic hras increased both secretion and uptake of exosomes through activation of pi k signalling. summary/conclusion: release and uptake of exosomes is altered in d environments. these studies help provide insight into exosome production and uptake in vivo and have potential implications for therapeutically targeting exosome release and the development of exosome based therapeutic delivery vehicles. introduction: previous studies in our lab found that expression of r w-fibulin- induces rpe to undergo emt. the purpose of current study was to characterize the extracellular vesicles (evs) in rpe cells expressing wt-fibulin- versus rpe cells expressing r w-fibulin- and investigate the effects of these evs on rpe cell differentiation. methods: arpe- cells were infected with lentivirus with luciferase-tagged wild-type (wt)-fibulin- or luciferase-tagged r w-fibulin- . evs were isolated from the media of arpe- cells by conventional ultracentrifugation or density gradient ultracentrifugation. transmission electron microscopy (tem) and cryogenic electron microscopy (cryo-em) were performed to study the morphology of the evs. the amount and size distribution of evs were analysed by nanosight tracking analysis (nta). ev protein concentrations were quantified using the dctm protein assay (bio-rad). ev cargo were analysed by unbiased proteomics using lc-ms/ms with subsequent pathway analysis (advaita). migration ability was evaluated in arpe- cells with or without the exposure of evs by conducting scratch assays. results: morphologically, tem imaging showed concave-appearing vesicles and cryo-em imaging showed spherical vesicles with two subpopulations of evs: a small group with diameters around nm and a large group with diameters around nm. moreover, tem and cryo-em showed an increased amount of small evs (~ nm) in the mutant group compared to the wt group. this result was further confirmed by nta showing that, in the mutant group, the particle size distributions were smaller than the wt evs. no significant differences were shown in ev protein concentrations per particle between wt and mutant groups. our previous data suggest that the expression of r w-fibulin- causes rpe cells to undergo emt as evidenced by upregulated emt drivers and an increased migration ability. proteomic studies showed that evs derived from arpe- cells overexpressing wt-fibulin- contain critical members of sonic hedgehog signalling (shh) and ciliary tip components, whereas evs derived from rpe cells overexpressing r w-fibulin- contain emt mediators, indicating that ev cargo reflects the phenotypic status of their parental cells. ev transplant studies showed that exposing native rpe cells to mutant rpe cell-derived evs containing emt drivers, including tgf-β-induced protein (tgfbi), vim, and smad , leads to an enhanced migration ability of rpe cells in a dosedependent manner. introduction: despite of high expectations, mesenchymal stromal cell (msc)-based therapies still lack efficacy, partially due to loss of cell viability and function upon administration. msc-derived extracellular vesicles (msc-ev) emulate the regenerative potential of msc, shifting the field towards cell-free therapies. clinical applications require the establishment of a scalable and gmp-compliant processes for the production and isolation of msc-ev, combined with robust characterization platforms. methods: to develop a well-established process for the production of therapeutic msc-ev, we compared different msc sources (bone marrow, adipose tissue, umbilical cord matrix), culture media compositions (dmem supplemented with foetal bovine serum (thermo fisher scientific), dmem supplemented with human platelet lysate (aventacell biomedical) and stempro msc sfm xeno free medium (thermo fisher scientific)) and culture parameters (oxygen tension and shear stress) in two different culture platforms ( d static tissue culture flask vs d dynamic spinner vessels). subsequently, msc-ev were isolated by ultracentrifugation or a commercially available isolation kit and characterized according to isev guidelines. results: msc derived from different sources/donors were able to grow under normoxia and hypoxia in d t-flasks and d spinner vessel culture systems, while maintaining their immunophenotype and differentiation potential, according to the minimal criteria defined by the isct. the time point for pre-conditioning and collection of conditioned medium for msc-ev isolation was also optimized for both d and d culture systems. introduction: extracellular vesicles (evs) have great potential in prostate cancer (pca) diagnosis and progression monitoring to complement the inaccurate prostate specific antigen (psa) screening and invasiveness of tissue biopsy. however, current methods cannot isolate pure evs and therefor evs characteristics remain largely unknown. in order to develop an accurate approach for ev isolation, we aimed to compare three emerging methods with different characteristics of small evs (sevs) from human pca plasma samples and to choose the best one for diagnostic and functional studies methods: pca patients and age-matched healthy controls (hc) plasma (n = in each group) were used to isolate sevs with different isolation methods including commercial exoquick ultra kit, qev and qev size exclusion chromatography (sec). isolated sev were characterized by nanoparticle tracking analysis, immunoblotting, cyrogenic electron microscopy, flow cytometry (fc) and proteomics analysis. for fc characterizing surface marker expression, the sevs were further purified by cd and cd commercial immunoaffinity magnetic beads . lipoprotein was captured by streptavidin biotinylated apob magnetic beads to measuring the lipoprotein contamination results: the sev size, morphology, surface protein and protein cargo with proteomics were analysed between the three isolation methods. sevs isolated from sec methods had a lower particle size, protein amount, protein/sev marker ratio and apob+/sev marker ratio than those from exoquick ultra method. in addition, sevs isolated from qev demonstrated a significantly higher sev content, more up-regulated and down-regulated pca proteins from proteomics but lower sev marker/protein ratio and a higher protein contamination than those from qev . furthermore, sev marker signal also showed a good correlation with particle numbers instead of protein content in all the methods summary/conclusion: qev method demonstrated better performance in isolating relatively pure sevs from human plasma; qev has the better performance in isolating samples with higher sev content; exoquick ultra isolated samples with closely sev content to the qev but with the highest non-sev protein contaminations. introduction: extracellular vesicles (evs) are released to biological fluids from different tissues and organs and they contain molecules proposed as biomarkers for multiple pathological conditions. however, most ev biomarkers have not been validated due to the lack of sensitive techniques compatible with high-throughput analysis required for routine screenings. using immunocapture techniques, combining antibodies against tetraspanins and candidate tumour-specific markers we have recently optimized several assays that greatly facilitate ev characterization. methods: we have improved flow cytometry and elisa assays, increasing substantially the sensitivity for ev detection. using dls, em and analytical ultracentrifugation, we have characterised the biophysical basis of this enhancement. the final methodology can be performed in any laboratory with access to conventional flow cytometry or elisa reader. results: using combinations of antibodies specific for the tetraspanins cd , cd and cd , it is possible to detect evs in minimal volumes of urine and plasma samples without previous enrichment. additionally antibodies against other less abundant markers, like the epithelial marker epcam, have been used to capture and identify evs directly in minimal volumes of urine or plasma with sensitivity higher than western blot analysis of isolated evs. furthermore, we demonstrate that additives altering the biophysical properties of an ev suspension, increased detection of tumour antigens in these immune-assays. summary/conclusion: the development of sensitive, high-throughput methods, easily translatable to clinical settings, as elisa and flow cytometry described here, opens a new avenue for the systematic identification of any surface marker on evs, even scarce proteins, using very small volumes of minimally processed biological samples. these methods will allow the validation of ev biomarkers in routine liquid biopsy tests. introduction: when ev subpopulations are enriched on antibody microarrays and probed for their surface proteins, the detection signal is biased towards abundant subpopulations as it is dependent on both the protein expression level and the number of evs captured. to address this challenge, we developed a novel normalization approach allowing: ) the estimation of a target signal independent of ev subpopulation size through dye-based ev quantification, and ) the assessment of subpopulation target enrichment relative to the population average by leveraging tim as an unbiased, lipidbased ev capture. here, we investigated the expression of cancer-associated proteins, particularly metastasisassociated integrins (itgs), in breast cancer evs with varying metastatic potential and organotropism. methods: the relative protein enrichment profiles for various ev subpopulations were established from evs of skbr (her +), t d and mcf- (er+pr+), bt and mda-mb- (triple negative) breast cancer cell lines, as well as five mda-mb- -derived cell lines of four different organotropisms (brain, bone, lung, liver) using our custom antibody microarrays with our normalization approach. results: as expected, her was broadly detected in her + skbr evs. interestingly, her -t d and mcf- evs also expressed her where it was highly enriched in its epcam+ subpopulations. itg α , β and β were only found in triple negative and organotropic evs with itg β and β differentially enriched based on the organotropism. the population average of mda-mb- and lung-tropic evs had high expression of itg β , where subpopulations of cd + evs showed positive enrichment while cd + and cd + evs showed negative enrichment. itg α , β and β were absent in the bone-tropic cd + ev subpopulation, a profile atypical in other organotropisms. lastly, egfr was negatively enriched in tetraspanin+ subpopulations in mda-mb- evs, but positively enriched in these subpopulations in organotropic evs, especially for brain-tropism. summary/conclusion: following normalization, we were able to quantify specific protein associations, uncovering a multitude of co-enrichment profiles that characterize specific metastatic and organotropic cell lines. notably, we found enrichment signatures that distinguish between different organotropisms derived from the same parental cancer line. op . = pf . heparan sulphate proteoglycans are required for ev-mediated delivery of multiple growth factors sara veiga, alex shephard, alex cocks, aled clayton and jason webber cardiff university, cardiff, uk introduction: the tissue microenvironment surrounding tumours is complex and the cross-talk between cancer and non-cancer cells is essential for tumour growth and progression. we have previously shown that heparan sulphate proteoglycans (hspgs), on the surface of prostate cancer evs, are required for delivery of tgfβ and initiation of a disease-supporting fibroblast phenotype. however, hspgs are known to bind numerous growth factors, so here we have explored the repertoire of such proteins tethered to evs by hspgs. methods: evs were isolated from du prostate cancer cell conditioned media by ultra-centrifugation onto a sucrose cushion. vesicular hspgs were modified either by removal of heparan sulphate (hs) glycosaminoglycan (gag) chains using the enzyme heparinase iii (hepiii), or attenuation of hspg core protein expression using shrnas to knockdown specific hspgs within the parent cell. differences in proteins present in control vs modified evs were identified by a sensitive protein array, based on proximity-ligation technology, and selected targets validated by elisa. functional delivery of growth factors by ev-associated hspgs to recipient fibroblasts is being explored using a variety of in vitro techniques. results: proteome analysis identified targets that bind to hs-gag chains, and also different proteins that showed altered expression following the loss of one or more hspgs from evs. using elisa, we have been able to quantify selected candidates on wild type vesicles, some of these are lost following hsdigestion. we were also able to validate proteins on hspg-deficient vesicles. gene ontology analysis suggests that ev hspg-mediated delivery of growth factors is important for control of processes such as angiogenesis, tumour invasion and immune regulation. functional validation of proteins identified is ongoing. summary/conclusion: here we demonstrate that hspgs play a key role in loading of evs with a complex assortment of growth factors, and therefore subsequent ev-mediated growth factor delivery. we anticipate that loss or damage of ev- introduction: methamphetamine (ma) and related amphetamine compounds, which are potent psychostimulants, are among the most commonly used illicit drugs. neuroimaging studies have revealed that chronic ma abuse can indeed cause neurodegenerative changes in the brains of human ma abusers including prominent microglial activation throughout the brain. it is still unclear how chronic inflammation caused by ma abuse leads to long-term damage to the brain. with this in mind, we are particularly interested in studying the role of extracellular vesicles (evs) in eliciting chronic inflammation in ma exposed brains. in the present study, we focus on the role of a mirna, mir- a- p (mir- a) in chronic ma exposure. here, we present novel data that shows for the first time how chronic ma impacts not only the biogenesis but also the ev associated mirna cargo thereby affecting the overall health of the neurons and glial cells in the brain. methods: -density gradient centrifugation for isolation of brain-derived vesicles -characterization of bdes by western blotting, nanoparticle tracking analysis and transmission electron microscopy -quantitative rt-pcr -digital droplet pcr -confocal imaging of dendritic spines and synapses results: in the present study, we show from both in vivo and in vitro studies that chronic methamphetamine (ma) treatment alters ev biogenesis and microrna (mirna) cargo. brain-derived evs (bde) isolated from frontal grey tissue of rhesus macaques that were administered ma in a chronic regimen revealed a significant increase in both number and size. further analysis revealed increase in biogenesis genes and increased levels of mirna, mir- a- p (mir- a). in situ hybridization of the frontal brain area revealed that mir- a was exclusively expressed in microglia and neurons. further, in vitro studies revealed that ev associated mir- a elicited not only neuronal damage but also was able to activate microglia to release pro-inflammatory cytokines thereby inducing a chronic inflammatory cycle. finally, we show that an anti-inflammatory drug was able to rescue inflammation, mir- a levels and synaptodendritic injury. summary/conclusion: in summary, our results present for the first time show that chronic ma exposure in the brain affects ev biogenesis and mirna expression. we further confirm that mir- a can serve as potential marker to diagnose synaptic deficits for chronic ma addiction in humans. finally, we reveal that anti-inflammatory drug could rescue the ev biogenesis and reduces the secretion of mir- a, thereby rescues synaptodendritic injury. our data further supports the use of the anti-inflammatory drugs as therapeutic interventions for ma addiction. funding: nida funding # r da blood-borne and brain-derived ectosomes/microparticles in morphineinduced anti-nociceptive tolerance deepa ruhela, veena bhopale, ming yang, kevin yu, eric weintraub, aaron greenblatt and stephen r. thom university of maryland school of medicine, baltimore, usa introduction: opioid pain treatment is impeded because chronic administration decreases analgesia, a condition called tolerance that prompts dose escalation contributing to morbidity and mortality. inflammatory interleukin (il)- β is required for tolerance development, so we hypothesized that pro-inflammatory extracellular vesicles (evs) play a role. methods: evs with opioid administration were assayed in mice and humans. annexin v-positive, . - µm diameter microparticles (mps) were assessed by flow cytometry in murine and human blood and in murine deep cervical lymph nodes that drain brain glymphatics. blood-borne exosomes (< nm) were assayed by tunable-resistance pulse sensing (trps). anti-nociceptive tolerance following morphine administration to mice was assessed by speed of tail removal from warm water. results: repetitive morphine dosing of mice to induce anti-nociceptive tolerance increased blood-borne mps by eightfold, and by tenfold in cervical lymph nodes. mps expressed proteins specific to neutrophils, microglia, astrocytes, neurons and oligodendrocytes. il- β content of mps increased -fold. administration of an il- β antagonist to mice diminished blood and glymphatic mps elevations and abrogated tolerance induction. intravenous polyethylene glycol telomer b that lyses mps and intraperitoneal methylnaltrexone that binds peripheral opioid-mu receptors and myeloid differentiation factor- to inhibit toll-like receptors, inhibited mps elevations and tolerance. neutropenic mice did not develop anti-nociceptive tolerance, elevations of blood-borne mps or cervical node mps expressing microglial proteins. elevations of blood-borne exosomes were not identified based on trps analysis. patients entering treatment for opioid use disorder exhibited similar mps elevations as do tolerant mice. summary/conclusion: neutrophil-derived mps containing il- β are required for morphine-induced antinociceptive tolerance. funding: this project was supported by grant n - - - from the office of naval research and an unrestricted grant from the national foundation of emergency medicine. evs are a conveyor of toxic dipeptide repeat proteins in c orf als/ ftd models thomas jefferson university, philadelphia, usa introduction: amyotrophic lateral sclerosis (als) is a neurodegenerative disease characterized by loss of motor neurons. in als, motor symptoms initiate focally and then progress gradually, distal from the initial focus. abnormal forms of als-associated proteins are physically exchanged between neuronal cells. pathogenic als proteins like sod , fus and tdp are transmitted between cells by assisted mechanisms, mainly extracellular vesicles (evs), spreading toxicity and misfolding of native proteins within the recipient cells. an intronic g c aberrant nucleotide repeat expansion in c orf gene is the most common genetic cause of als. translation of this expanded region occurs by a process called repeat associated non-aug (ran) translation that produces five dipeptide repeats proteins (dprs), polyga, polygp, polygr, polypa and polyga. polyga, polygr and polypr are associated with toxicity in neurons. in this work we study the recruitment of these aberrant proteins into extracellular vesicles (evs) and the potential role of these evs in spreading toxicity between cells of the central nervous system. methods: to isolate the evs from cell culture media we isolated by ultracentrifugation the larger vesicles at , xg and the smaller evs at , xg. number, size and fluorescence of the vesicles were analysed by fluorescent nanotrack analysis (f-nta) and by cytoflex. the protein content of the vesicles was analysed by western blot (wb). to evaluate the potential toxicity of the evs, a transwell system (tw) was employed. neuron viability was assessed using live imaging techniques. results: nsc were transfected with reporter constructs expressing dprs tagged with gfp protein. by f-nta, cytoflex and wb analysis we assessed that all the five dprs were loaded in both the large and the small vesicles isolated from cell culture medium. by tw, nsc transfected with the dprs were put in contact with primary cortical neurons (cns) transfected with synapsin driven td-tomato for live imaging purposes. we observed that polygr+ nsc were able to cause a significant decrease in cns viability. we also observed that polygr+ evs associated toxicity was directly dependent on polygr length. this effect was reverted reducing the number of polygr+ evs treating nsc with gw . to understand the downstream effect of polygr+ evs in recipient cells we studied tdp mislocalization, ran-translation and activation of the integrated stress response, finding a dysregulation of all these potentially toxic pathways in neurons treated with polygr+ vesicles. summary/conclusion: concluding, dprs are actively secreted in evs and polygr+ vesicles cause the activation of toxic mechanisms in the recipient cells, possibly contributing to the spreading of als introduction: pregnancy is the a condition that profoundly mitigates symptoms of multiple sclerosis (ms) a complex disease characterized by immune dysfunction and neurodegeneration affecting . million people worldwide. serum exosomes, released by specific cells during pregnancy, modulate the immune and central nervous system function and contribute to pregnancy-associated suppression of experimental autoimmune encephalomyelitis (eae), an induced preclinical model of ms. extracellular vesicles (evs) are the new means for communication among cells. the aim of our study was to characterize the ability of human amniotic fluid stem cells-derived evs (hasc-evs) to antigen presenting cell function thus correcting immune dysfunction in eae. methods: amniotic fluids were obtained from human - -week pregnant women. hasc-evs were collected by ultra-centrifugation. evs were characterized for their specific proteins, lipids and nucleic acids expression. the ability of evs to modulate immune responses was performed in vitro, testing the ability of evs to induce a tolerogenic phenotype in mouse bone marrow derived dendritic cells, and in vivo for their potential to suppress eae, induced by immunization c /b female mice with mog - peptide. results: we found that hasc-evs expressed high levels of galectin- and promoted a significant increase of the immunoregulatory enzyme indoleamine , dioxygenase- enzyme in dcs. moreover in in vivo experiments administration of hasc-evs significantly reduced disease severity in eae. such effect was associated with reduced neurological deficits and suppression of pathogenic t helper (th ) cells, and increased percentage of regulatory t cells (treg-foxp +) cells. summary/conclusion: our findings unravel immunoregulatory effects of evs secreted by hascs. evs may represent a novel cell-free immune regulatory and regenerative therapeutic approach that can potentially mitigate immune dysfunction and promote remyelination. association of neuronal-derived extracellular vesicles cargo with cognitive decline in late middle life introduction: alzheimer's disease (ad) is characterized by a long preclinical stage during which phosphorylated tau pathology spreads in the brain leading to clinical symptoms. pathogenic tau spreads, in part, via extracellular vesicles (evs). we and others have demonstrated that tau cargoes of neuronal-derived evs (nevs) from blood can serve as biomarkers for ad. we aimed to examine whether nev tau cargo can predict cognitive decline in late middle age by leveraging samples from participants in the wisconsin registry for alzheimer's prevention (wrap) study. methods: we blindly immunoprecipitated nevs using antibody against neuronal l cell adhesion molecule (l cam) from serum samples of wrap participants who were cognitively unimpaired at baseline (mean age . ± . years old; . % females; . % apoe carriers), of whom half subsequently developed cognitive decline. we measured phosphorylated (p and p ) and total tau in nevs using electrochemiluminescence assays. we used linear regression models to identify differences between cognitive status groups including age, sex apoe status and the cognitive status*age interaction in the model. results: at baseline, we found trends for higher p -(p = . ) and p -tau (p = . ) levels in future decliners compared to stable participants. further, there were significant cognitive status*age interactions for ptau (p < . ), total tau (p < . ) and ptau (p < . ) with higher levels with increasing age in future decliners summary/conclusion: nev tau cargo differs between late middle-aged individuals at risk for ad with and without future cognitively decline even before decline occurs, presumably due to subclinical spread of tau pathology. further nev biomarker development may allow preclinical ad diagnosis. introduction: in the brain, circulating extracellular vesicles (evs) in the cerebrospinal fluid (csf) contain a variety of signalling factors, including proteins, enzymes, and rna transcripts. while evs have been implicated in many cell-to-cell signalling contexts, the vast majority of these studies are based on findings derived from cell culture conditions. thus, the ability to identify cell typespecific ev release from cellular subpopulations within the brain represents a critical barrier in the field. methods: to address this knowledge gap, we utilized a novel transgenic mouse model to determine the release of cell-type specific evs. here we report the exomap- mouse, which is designed to express an exosomal green fluorescent protein in response to expression of cre recombinase. specifically, the exomap- transgene was inserted at the mouse h locus and consists of (i) a broadly expressed cag promoter/enhancer, (ii) a floxed orf encoding mts-tdtomato, (iii) an orf encoding the exosomal protein acyltya fused to mneongreen (mng), and (iv) a ʹ utr containing the wpre element and polyadenylation signal from the bovine growth hormone gene. results: intracranial ventricular injections of the viral vector aav-ttr-cre, which drives cre recombinase expression from the choroid plexus-specific promotor of the transthyretin gene, leads to acyltya-mng expression in the choroid plexus. moreover, we observed that these mice released mneongreen-positive evs into the cerebrospinal fluid and also visualized the vesicles in the blood. furthermore, these mice displayed an accumulation of acyltya-mng fluorescence in the medial habenula. summary/conclusion: the results indicate that choroid plexus-derived evs are trafficked to the csf and the medial habenula, and more generally, that the exomap- mouse can be used to follow the trafficking of tissuespecific evs into biofluids and between tissues in vivo. introduction: large-scale colorectal cancer (crc) sequencing studies have shown that % of all tumours had at least one mutation in proteins implicated in the wnt signalling pathway. mutations in β-catenin have often been associated with the constitutive activation of wnt signalling pathway and has been established as a major driver of crc. one of the proposed mechanisms of activating wnt signalling involves extracellular vesicles (evs) as cellular couriers to transfer wnt ligands from one cell to another. however, the association of oncogenic mutant β-catenin with evs has not been studied. subpopulations of cancer cells with different mutational loads and behavioural variations lead to intra-tumour heterogeneity methods: integrative proteogenomic analysis showed the secretion of mutant β-catenin via evs. evs were isolated by ultracentrifugation and optiprep density gradient centrifugation. silac-based quantitative proteomics analysis, immunofluorescence, biochemical analysis, qpcr and xenograft models were employed to unveiling the role of evs carrying mutant βcatenin. results: an integrative proteogenomic analysis identified the presence of mutated β-catenin in evs secreted by colorectal cancer (crc) cells. follow up experiments established that evs released from lim crc cells stimulated wnt signalling pathway in the recipient cells with wild type β-catenin. silac-based quantitative proteomics analysis confirmed the transfer of mutant β-catenin to the nucleus of the recipient (rko crc) cells. in vivo tracking of dir labelled evs in mouse implanted with rko crc cells revealed its bio distribution, confirmed the activation of wnt signalling pathway in tumour cells and increased the tumour burden. introduction: there has been a significant increase in incidence of human papillomavirus (hpv ) driven oropharyngeal cancer (opc) in developed countries. there is evidence that hpv alters the molecular cargo of exosomes released by opc. emerging evidence suggests that hpv integration within the human genome is associated with both genomic and transcriptomic alterations. consistent with previous studies, the genomic viral-cellular junctions were identified using dips-pcr method in ( %) saliva samples collected from hpv -driven opc. methods: morphology and molecular features of exosomes derived from three different saliva sampling methods: unstimulated saliva; acid-stimulated saliva; and salivary oral rinses were examined using transmission electron microscopy (tem), nanoparticle tracking (nta) and western blot analysis. hpv- dna detection in salivary exosome was determined by using qpcr method. proteome profile of salivary exosomes derived from both cancer-free controls and hpv -driven opc patients was characterized using liquid chromatography-electrospray ionization-tandem mass spectrometry (lc-ms/ms). results: we demonstrate that unstimulated saliva had greater abundance of exosomes when compared to the other sampling methods. three common exosome markers (cd , cd and cd ) were higher in unstimulated saliva. only salivary exosomes derived from hpv-driven opc patients had a detectable level of hpv- dna. the proteomic signature of salivary exosome was significantly (p < . ) different between cancer-free controls and hpv-driven opc. we found elevated protein abundance of five main glycolytic enzymes (i.e. phosphoglycerate kinase (pgk ), glyceraldehye- -phosphate dehydrogenase (gapdh), aldolase (aldoa) and lactate dehydrogenase a (ldha) in salivary exosomes derived from opc patients, suggesting a functional role of salivary exosome in the reciprocal interplay between hpv-driven opc and glucose metabolism. summary/conclusion: our data suggest that the development of a low-cost non-invasive saliva-based test using both salivary exosomal dna and protein may offer an opportunity to detect hpv-driven opc, that may be clinically useful in managing these patients. continuous in vivo release of mast cell derived extracellular vesicles from an implanted device spreads pro-inflammatory response in mice introduction: mast cells are important players of the immune system and they secrete a wide range of mediators during bacterial infections. mast cells are also able to release extracellular vesicles (evs). here, we report that mast cells communicate with each other in vivo by evs. methods: we isolated bone marrow-derived and peritoneal mast cells from gfp-transgenic and wild type mice. evs were separated from the conditioned media of these cells cultured in the presence or absence of lipopolysaccharide (lps). evs were characterised according to the misev guidelines by flow cytometry, electron and fluorescent microscopy, trps, the spv lipid and the bca protein assays. separated ev-s were cultured with naïve mast cells, and tumour necrosis factor (tnf)-α production was tested by elisa and intracellular flow cytometry. gfp+ mast cells were seeded in diffusion chambers which were implanted into the peritoneal cavities of mice enabling us to investigate the continuous in vivo release of evs. uptake of gfp+ evs and tnf-α expression of peritoneal mast cells were tested by flow cytometry and fluorescent microscopy. results: here, we showed that bacterial lps-sensing mast cells release evs that in turn, induce tnf-α expression in resting mcs in vitro. moreover, we confirmed that evs are transmitted to other peritoneal mast cells in vivo spreading the pro-inflammatory response by inducing tnf-α secretion in peritoneal mast cells. summary/conclusion: ev communication between members of the mast cell network, play an important role in spreading and escalating pro-inflammatory responses to immune stimuli. our data may provide an explanation how the relatively rare tissue resident mast cells can play key roles in diseases such as autoimmune arthritis. the ability of small extracellular vesicles (sevs) to reprogramme cancer cells is known. integrins, receptors for extracellular matrix proteins, are major players in mediating sev functions. previously, we have reported that the αvβ integrin is detected in sevs of prostate adenocarcinoma (prca) cells and transferred into recipient cells in a paracrine fashion; however, its role and expression have never been explored in the most aggressive forms of prca, such as neuroendocrine prca (neprca). neprca does not express androgen receptor (ar) but does express neuron-specific proteins, such as aurora kinase a, synaptophysin and neuron specific enolase, that activate pro-tumorigenic pathways independently from the ar. methods: we isolated sevs from prca c - b cells using iodixanol density gradients and characterized them by immunoblotting and exoview. the experiments were performed in vivo by injecting subcutaneously, in nude mice, du cells treated with sevs expressing or lacking the αvβ integrin, and in vitro, by testing anchorage-independent growth of different cell lines treated with the same sevs. discarded human tissues from prca metastasis were analysed by immunohistochemistry (ihc). results: we demonstrate that a single treatment of prca cells with sevs significantly stimulates tumour growth and anchorage-independent growth. moreover, we show that one treatment with sevs, shed from c - b cells that express αvβ , but not from the control cells that lack αvβ , induces differentiation of prca cells towards a neuroendocrine phenotype and downregulates ar. finally, our ihc analysis shows coexpression of αvβ integrin and synaptophysin in neprca metastatic lesions. summary/conclusion: in conclusion, our current study shows, for the first time, that αvβ integrin expression in donor cells generates sevs that reprogramme recipient cells towards an aggressive tumour phenotype. funding: this study was supported by nci-p - , r - to lrl. introduction: exosomes are small extracellular vesicles (sevs) that carry a variety of cargoes and have been shown to promote tumour cell motility and metastasis. cell motility is influenced by dynamic formation and stability of filopodia: actin-rich protrusions that extend from the leading edge and perform directional sensing. filopodia regulators such as fascin are upregulated in multiple epithelial cancers and can promote invasive phenotypes. however, how filopodia are induced and controlled by extracellular factors is poorly understood. here, we describe a role for sevs in regulating filopodia formation and tumour cell motility. we utilized b f melanoma cells and ht fibrosarcoma cells for fixed-and live-cell imaging to quantify filopodia numbers and dynamics in control and exosome-deplete conditions. itraq proteomics was used to identify sev protein cargoes that contribute to filopodia formation. in vivo experiments were performed using a chick embryo model for metastasis. results: inhibition of exosome secretion in cancer cell lines, via rab a or hrs knockdown, led to decreased filopodia numbers. specificity to sevs was demonstrated by rescue experiments in which purified sevs but not large evs rescued the filopodia phenotypes of exosome-inhibited cells. live imaging of hrs-kd cells revealed that exosome secretion regulates formation and stability of filopodia. proteomics data and molecular validation experiments identified the tgf-beta coreceptor endoglin as a key sev cargo regulating filopodia formation, cancer cell motility, and metastasis. summary/conclusion: in this study, we identified exosomal endoglin as a regulator of filopodia formation and in vivo metastasis. these data are relevant to cancer as endoglin expression is altered in many cancers. in addition, endoglin is the disease gene for hereditary haemorrhagic telangiectasia, and may influence angiogenesis. overall, our data implicate sev-carried endoglin as a key cargo regulating filopodia. astrocyte-derived ev-mediated blood-brain barrier disruption shilpa buch, ke liao, susmita sil, fang niu and guoku hu university of nebraska medical center, omaha, usa introduction: the breach of the blood-brain barrier (bbb), resulting in ensuing neuroinflammation, is a key feature of hiv-associated neurological disorders (hands). while combination antiretroviral therapy (cart) has successfully suppressed peripheral viraemia, cytotoxicity associated with the presence of viral tat protein in tissues such as the brain, remains a significant concern. our previous study has demonstrated that hiv- tat can induce disruption of bbb by downregulation of tight junction (tj) proteins in human brain microvascular endothelial cells (hbmecs) and that this is regulated by the autophagic pathways. methods: evs were isolated from hiv tat-stimulated mouse/human primary astrocytes using the standard differential ultracentrifugation method and characterized by transmission electron microscopy, nanosight & western blot analyses. among the various mirs dysregulated in hiv tat -stimulated astrocyte ev cargo, mir- was found to be upregulated by realtime pcr. confocal microscopy identified uptake of astrocytic evs by hbmecs. functional assessment of astrocytic ev uptake by hbmecs involved cell permeability using transepithelial electrical resistance as well as trans-well endothelial cell monolayer permeability assays. results: hiv- protein tat-mediated induction of micrornas (mirs) in astrocyte-derived extracellular vesicles (adevs) regulated the permeability of bbb by targeting the expression of tj proteins in the hbmecs. exposure of hbmecs to tat-adevs resulted in down-regulation of the tight junction protein claudin , resulting in increased endothelial cell monolayer paracellular permeability. microarray data of tat-adevs demonstrated upregulation of several mirs compared to that of controls, among which upregulated mir- was identified to target the tj proteins using ingenuity pathways analysis. increased expression of mir- was validated in tat exposed astrocytes and tat-adevs. adevs loaded with mir- oligos showed similar effects as that observed with tat-adevs in inducing permeability in hbmecs. increased expression of mir- with downregulation of claudin- was also recapitulated in microvessels isolated from the brains of doxycycline-inducible hiv- tat transgenic mice (itat) mice and in lysates isolated from the frontal cortices of siv+ macaques/hiv+ autopsied brains. summary/conclusion: our findings demonstrated that tat-adevs containing mir- as an important mediator underlying tat-mediated disruption of the bbb. introduction: endogenous exosomes and related extracellular vesicles (evs) are potent nanoparticles released by all cells tested to date. the exploitation of their unique scaffolding for engineering next-generation drug delivery systems represents a major area of academic and commercial interest. the lag in exploiting this potential is in part due to our inability to measured extent and efficiency of modification, e.g., composition and drug loading. here we report a robust pipeline of optical tweezing combined with raman spectroscopy to molecularly characterize engineered evs and quantitatively assess extent of drug loading at single particle resolution. methods: evs derived from cell culture and isolated by ultracentrifugation were fused with synthetic liposomes to create engineered evs (eevs). these eevs were formed via well-established vesicle fusion techniques, namely ( ) mechanical extrusion, ( ) freeze-thawing, or ( ) probe-tip sonication. prior to formation, calcein was encapsulated in the liposomes and used as a surrogate for soluble drug loading. laser trapping raman spectroscopy (ltrs) was used to optically trap single evs, before and after synthetic manipulation. raman spectral analysis was used to assess trapped eevs compared to pure standards to quantify ratiometric variation in chemical composition. results: raman laser trapping experiments confirmed that each formation method results in largely varying ( ) extent of fusion between evs and synthetic calceinloaded liposomes, ( ) efficiency of calcein loading, and ( ) particle size. we could also quantify the molar amounts of liposome vs. ev molecules for single particles, revealing a great amount of variation from particle to particle. functional membrane proteins we left intact to varying degree across fusion methods. summary/conclusion: given the rising importance of analytical tools able to characterize extent of molecular loading for engineered evs, we believe this technology will be very useful, thus warrants further investigation for eev characterization across a variety of clinical applications. funding: randy carney, phd was supported by a research scholar grant, rsg- - - -cdd, from the american cancer society. extracellular vesicles containing host restrictive factor ifitm inhibited zika virus infection of foetuses in pregnant mice through trans-placenta delivery allen z. wu nanjing university, nanjing, china (people's republic) introduction: zika virus (zikv) infection can lead to neurological complications and foetal defects, and has attracted global public health concerns. effective treatment for zikv infection remains elusive and a preventative vaccine is not available yet. therapeutics for foetus need to overcome blood brain barriers to reach placenta and require higher safety standard. methods: in the present study, we engineered mammalian extracellular vesicles (evs) to deliver a host restrictive factor, interferon-induced transmembrane protein (ifitm ), for the treatment of zikv infection. results: our results demonstrated that the engineered ifitm -containing evs (ifitm -exos) were overall safe to the animals and suppressed zikv viraemia by log s in the pregnant mice. moreover, the engineered evs effectively delivered ifitm protein across placental barrier and suppressed overall zikv viraemia in the foetuses to the basal level with significant reduction of viraemia in key foetal organs as measured by q-pcr. mechanistic study showed that ifitm was delivered to the endosomes/lysosomes where it inhibits viral entry to the host cells. summary/conclusion: our study demonstrates that exosomes can act as a cross placenta drug delivery vehicle to foetus and ifitm , an endogenous restriction factor that is highly expressed in placenta, is a potential treatment for zikv infection during pregnancy. introduction: extracellular vesicles (ev) are natural and abundant nanoparticles capable of transferring complex molecules between neighbouring and distant cell types. translational research efforts have focused on co-opting this communication mechanism to deliver exogenous payloads to treat a variety of diseases. important strategies to maximize the therapeutic potential of evs include payload loading, functionalization of the ev surface with pharmacologically active proteins, and delivery to target cells of interest. methods: through comparative proteomic analysis (lc/ms) of purified evs, we identified several highly enriched and ev-specific proteins, including a transmembrane glycoprotein (ptgfrn) belonging to the immunoglobulin superfamily. leveraging ptgfrn as a scaffold for surface display, we generated evs with functional targeting ligands, including single domain antibodies (sdabs), single chain variable fragments (scfvs), single chain fabs (scfabs), and receptor ligands, on the surface to direct ev uptake to cell types of interest. biological activity of these engineered evs was assessed in an array of in vitro and in vivo assays and compared to untargeted controls. results: we engineered evs displaying anti-clec a scfabs to target conventional type dendritic cells (cdc s), anti-cd scfabs to target t cells, and cd ligand to target b cells. in mice, systemic administration of anti-clec a evs resulted in a % increase in the percentage of cdc cells that take up evs over controls. anti-cd evs resulted in both an increase in the percentage of ev positive t cells ( . and -fold for cd + and cd +) and the number of evs per cell ( and -fold for cd + and cd +) in the blood. furthermore, in primary mouse dendritic cells, anti-clec a evs loaded with sting agonist achieved a fold greater pathway induction compared to untargeted controls. preliminary in vivo data suggest that anti-clec a evs reduce the required sting agonist dose -fold to achieve efficacy and induce anti-tumour responses, compared to control evs. summary/conclusion: these results demonstrate the potential of our ev engineering platform to generate novel ev therapeutics targeted to cell types of interest for pharmacologic payload delivery. a novel method for the delivery of cell-free therapy to foetuses with congenital anomalies: a proof of principle study lina antounians, louise montalva, gabriele raffler, maria sole gaffi and augusto zani the hospital for sick children, toronto, canada introduction: antenatal cell-based therapies are currently considered invasive for the foetus. a promising cell-free strategy that holds great regenerative potential for several organs is the administration of stem cell derived evs, whose cargo contains bioactive molecules that epigenetically regulate target cells. herein, we aimed to ) assess the ability of evs to reach foetal organs when administered to the mother intravenously or intra-amniotically; ) compare these administration routes on normal foetuses and foetuses with a congenital anomaly. methods: evs were isolated from rat amniotic fluid stem cell conditioned medium using ultracentrifugation. evs were assessed for size (nanoparticle tracking analysis), morphology (tem), and expression of cd , hsp , flo- , and tsg (western). we injected rat dams with evs stained by exoglow™-vivo or saline (control) via maternal tail vein (iv) or intra-amniotically (ia) at e . . ia and iv injections were performed on dams carrying normal foetuses or foetuses exposed to nitrofen to induce congenital diaphragmatic hernia. after h, dams and pups were sacrificed. d high-sensitivity optical reconstructions of whole foetuses or micro-dissected foetal organs were imaged using the ivis® spectrum imaging system. ev fluorescence signal was compared between normal (n = ) and nitrofen-exposed (n = ) foetuses. results: both iv and ia injection routes were successful in delivering evs to foetal organs. no fluorescent signal was detected in saline only control. ia injections yielded higher signal than iv, and evs reached more organs with ia than iv injections. ia injected evs were detected in the lungs, gastrointestinal, and urinary tract of normal and nitrofen-exposed foetuses. nitrofen exposed foetuses had higher signal than normal foetuses. summary/conclusion: this proof of concept study shows that antenatal administration of stem cell evs is feasible with different routes. although maternally administered evs cross the placenta, ia injection is more effective at reaching foetal organs. further studies are underway to reproduce these findings in experimental models of various congenital anomalies. funding: cihr-sickkids foundation grant os . introduction: safe, efficient and specific nano-delivery systems are essential to the current cosmetic, nutraceutical and therapeutic medicine sectors. the ability to optimise the bioavailability, stability, and targeted cellular uptake of bioactive molecules while mitigating toxicity, immunogenicity and off-target/side effects is of the utmost priority. ves us is a european project, which aims to develop an innovative platform for the efficient production of extracellular vesicles (evs) from microalgae, which constitute a promising renewable bioresource (www.ves us.eu). here we present characteristics of evs from several microalgal lineages, which offer the opportunity for a potentially developing a new and scalable tailor-made biogenic nanotechnology. methods: we cultivated a number of ev-producing microalgal species and developed protocols for ev isolation both at laboratory (differential ultracentrifugation) and pilot scales (tangential flow filtration). the physico-chemical characterization of microalgal evs was carried out according to the minimal information for studies of extracellular vesicles (misev- guidelines): biochemical methods to verify the presence of specific ev-biomarkers, tuned for microalgal evs; dynamic light scattering (dls) and nanoparticle tracking analysis (nta) to assess the particles number and size distribution; electronic scanning microscopy (sem), atomic force microscopy (afm), and cryo transmission electron microscopy (cryo-tem) for imaging analyses; bilayer-specific fluorescence staining (f-nta) to test the purity of ev preparation. results: we identified microalgae as a novel natural source of evs that could constitute a cost-effective and sustainable way of mass-producing them. we screened strains of microalgae and generated an "ev identity card" for each, which contained a variety of ev features relating to their biophysical, biochemical and biological characteristics in line with the misev- . our approach will next focus on the scalable production, surface functionalization and bio-engineering of selected microalgal evs. at the same time, their bioactivity will be explored using both in vitro and in vivo biological models. summary/conclusion: the ves us consortium is investigating the potential of microalgae as novel ev bioresources. this research will attempt to bioengineer novel naturally-derived nanocarriers, microalgal evs, suitable for the development of future cosmetics, nutraceutical or therapeutic formulations. funding: this project has received funding from the european union's horizon research and innovation programme under grant agreement no . sequence-specific rna trafficking to extracellular vesicles is conserved across cell types several sequences have been identified that act as a zipcode for preferential rna targeting into ev (evtropic) or for retention in parental cells (cell-tropic) . in this work, we aimed to compare the ev-tropic capacity of specific rna sequence motifs in promoting loading into ev, across different cell models representing the main cell types found in the body. methods: immune, epithelial and mesenchymal cell lines were transiently transfected with xenogeneic c. elegans micrornas (mirnas) containing ev-tropic or cell-tropic sequences and grown in culture. ev were isolated from the supernatant by differential (ultra)centrifugation. rna was extracted from both cell pellets and isolated ev fraction, and target mirnas were quantified by digital droplet pcr. distribution of cargo mirna across cells and ev was also analysed for chimeras of ev-and cell-tropic sequences. results: the mirnas containing an ev-tropic sequence were highly enriched on the ev fraction, with - , higher levels than in parental cells. contrarily, cell-tropic mirnas were only - times higher in ev. no significant differences were observed in the ev loading efficiency for the various ev-tropic motifs tested. mutations in the ev-sorting motif resulted in reduced ev loading. ev-tropic sequences consistently promoted mirna loading into ev across all the cell models evaluated, suggesting conserved biological mechanisms. summary/conclusion: we showed that rna loading into ev is dependent on the presence of defined evtropic rna motifs, and that sorting mechanisms are conserved across the major cell types tested. the highest loading efficiencies resulted in . mirna copies per particle on average, suggesting a limited scope for ev-tropic motifs for therapeutic rna loading into ev. funding: as, os and eli are fellows of the astrazeneca postdoc programme. introduction: coordinated activity between pancreatic islet cells is critical for the regulation of glucose homoeostasis. chronic exposure to diabetogenic factors such as pro-inflammatory cytokines, perturb islet cell crosstalk and β-cell function in diabetes. extracellular vesicles (evs) derived from cytokine-exposed β-cells modulate physiological and pathological responses to β-cell stress. however, the mechanisms governing this process remain largely unknown. we set out to test the hypothesis that β-cell failure in diabetes is mediated in part through β-cell autocrine release of pro-inflammatory evs which promote inflammation and inhibit βcell function. methods: pro-inflammatory cytokine-exposed evs (cytoevs) were generated using conditioned media from mouse min β-cell line treated with diabetogenic cytokines (tnfα, il- β, ifnγ, h). evs were also isolated from human type diabetic (t dm) and lean non-diabetics (lnd) plasma. gw (n-smase inhibitor) was used in the presence of cytokines to determine the effect of reduced ev concentrations on the restoration of β-cell function. proteomic and rna-seq analysis was conducted on min β-cell cytoev (vs. control ev) and cytoev treated mouse islets, respectively. results: assessment of ev concentrations from cytoev and human t dm plasma revealed a~twofold increase (p < . , vs. control (ctl) and lnd ev). immunofluorescence staining of cd and cd expression was significantly elevated in human t dm pancreas (p < . , vs. lnd). while acute inhibition of ev formation with gw ( µm) showed significant restoration in β-cell function (glucose stimulated insulin secretion assay, gsis) in cytokine-exposed mouse and human islets (~ and fold vs. cytokines alone, p < . ). moreover, functional assessment of mouse islets exposed to cytoev ( h) resulted in suppression of gsis (~ %, vs. untreated, p < . ). identification of cytoev content through proteomic analysis revealed a significant upregulation of the chemokine, cxcl (~ fold vs. ctlev) and rna-seq analysis of cytoev treated mouse islets depicted a marked upregulation of transcripts associated with cxcl -cxcr signalling (p < . ) and downstream pathways (e.g. nfκb; p = . and jak/stat; p = . ). furthermore, inhibition of cytoev (gw ) with cytokines markedly decreased cxcl (~ %) and cxcr receptor (~ %) expression in min β-cells. summary/conclusion: these data suggests that cytokines elevate cxcl expression in β-cell ev to enhance inflammation-induced diabetes. this is mediated through ev-autocrine release of cxcl consequently activating cxcr signalling and downstream pathways to impair β-cell function in diabetes. synergy between -lipoxygenase and secreted pla promotes inflammation by formation of tlr agonists from extracellular vesicles introduction: damage associated molecular patterns (damps) are endogenous ligands that induce innate immune response, thus promoting sterile inflammation. during oxidative stress, stress-derived evs (stressevs) were found to activate toll-like receptor (tlr ), but the activating ligands were not fully determined. additionally, several enzymes, among them -lipoxygenase ( -lo) and secreted phospholipase a (spla ) are induced during inflammation and were suggested to promote damp formation. methods: stressevs were produced from hek cells exposed to um a and isolated with ultracentrifugation. : lysopi was oxidized for min with -lo. additionally, synevs were prepared from phospholipids (pls), oxidized with -lo and hydrolysed with spla . activity was measured by qpcr and elisa on wt and tlr -ko macrophages. -lo oxidized : lysopi was analysed by mass spectrometry. spla activity was measured in synovial fluid from rheumatoid and gout patients using fluorometric assay. k/bxn serum transfer induced arthritis model on wt and tlr ko mice (c bl/ mice) with spla -iia injection was used (approval no. u - / / by mkgp of slovenia). results: stressevs released after oxidative stress were found to activate tlr with a gene profile different from bacterial lipopolysaccharide (lps). stressevs, -lo oxidized synevs, but only -lo oxidized lysopls activated cytokine expression through tlr /md- . hydroxy, hydroperoxy and keto products of : lysopi oxidation were determined by ms and they activated the same gene pattern as stressevs. furthermore, spla activity, which we detected in the synovial fluid from patients, promoted formation of tlr agonists after -lo oxidation. injection of spla -iia into mice promoted k/bxn serum induced arthritis in tlr -dependent manner. summary/conclusion: both -lo and spla are induced during inflammation, therefore these results imply the role of oxidized lysopls in stressevs in promoting sterile inflammation through tlr signalling. the formation of tlr agonists is enzyme driven so it provides an opportunity for therapy without compromising innate immunity against pathogens. funding: h -msca-itn project tollerant (grant no. ), slovenian research agency (project no. j - to mmk, research core no. p - to rj). monocytes traffic extracellular vesicles to damaged muscle and adopt a novel immunophenotype to support muscle regeneration russell g. rogers, akbarshakh akhmerov, weixin liu, lizbeth sanchez and eduardo marbán smidt heart institute, cedars-sinai medical center, los angeles, usa introduction: extracellular vesicles (evs) are secreted membrane vesicles that carry bioactive molecules such as mirnas, mrnas, proteins, and lipids to modify recipient cell behaviour. we recently demonstrated evs secreted by cardiosphere-derived cells (cdc-evs) augment endogenous muscle regeneration in mdx mice, a model of duchenne muscular dystrophy, when delivered intravenously. in parallel, macrophages preferentially accumulate surrounding small regenerating myofibers in cdc-ev treated mdx muscle. however, it is currently unclear how intravenous cdc-evs home to dystrophic muscle and exert their therapeutic bioactivity. methods: fluorescently-labelled and unlabelled cdc-evs were infused into the contralateral femoral vein of wild-type mice with unilateral muscle injury induced by bacl . injured and uninjured muscles were dissected h following infusion and subjected to optical imaging, immunohistochemistry, and confocal microscopy. this experiment was repeated using clodronate liposomes to deplete endogenous monocytes/macrophages. next, rna-seq was preformed on bone marrow-derived m , m , and cdc-ev (mcdc-ev) polarized macrophages from mdx mice. conditioned media (cm) from these macrophages were tested in an in vitro model of myogenesis. lastly, small rna-seq was performed on evs secreted by m , m , and mcdc-ev macrophages. results: when delivered intravenously, cdc-evs naturally home to injured, but not uninjured, skeletal muscle. cdc-evs were detected in the interstitium adjacent to non-muscle cells, macrophages, and within surviving myofibers. after depletion of monocytes/ macrophages by clodronate liposomes, the presence of cdc-evs in the injured muscle was attenuated. bioinformatic analyses indicate cdc-evs confer a novel immunophenotype to mdx macrophages with features of both m and m . indeed, mcdc-ev cm promotes myoblast proliferation and supports myogenic differentiation. interestingly, mcdc-ev evs have a unique mirna signature and contain several mirnas with known roles in myogenesis. summary/conclusion: these data indicate circulating monocytes traffic cdc-evs to damaged muscle where they adopt a novel immunophenotype to support muscle regeneration. we propose mcdc-ev macrophages mediate their pleiotropic effects via paracrine factors, possibly including evs. introduction: microglia, the immunocompetent cells of the cns, play an important role in maintaining cellular homoeostasis in the cns. these cells secrete immunomodulatory factors including nanovesicles and participate in the removal of cellular debris by phagocytosis or autophagy. the contribution of microglial-derived extracellular vesicles (m-evs) to the maintenance of cns homoeostasis is unclear. in addition, knowledge of canonical signalling pathways of inflammation and immunity gene expression patterns in human microglia exposed to m-evs is scarce. methods: here, we analysed the effects of m-evs produced in vitro by either tnfα-activated or non-stimulated microglia bv cells. we showed that m-evs are internalized by both mouse bv and human c microglia and that the uptake of m-evs in microglia induced autophagic vesicles at various stages of degradation including autophagosomes and autolysosomes. consistently, exposure of microglia to m-evs increased the protein expression of the autophagy marker, lc b-ii, and promoted autophagic flux in live cells. to elucidate the biological activities occurring at the transcriptional level in c microglia exposed to m-evs, the gene expression profiles, potential upstream regulators, and enrichment pathways were characterized using targeted rna sequencing. results: inflammation and immunity transcriptome gene panel sequencing of both activated and normal microglia exposed to m-evs showed involvement of several canonical pathways and reduced expression of key genes involved in neuroinflammation, inflammasome and apoptosis signalling pathways compared to control cells. summary/conclusion: we demonstrate that in vitro produced microglial evs are able to influence multiple biological pathways and promote activation of autophagy in order to maintain microglia survival and homoeostasis. funding: this work was financed by hasselt university and by efro through the interreg v grensregio vlaanderen nederland project trans tech diagnostics. evaluation of plasma extracellular vesicles as biomarkers for longevity xin zhang a and virginia kraus b a laboratory medicine center, nanfang hospital, southern medical university, guangzhou, guangdong, , p. r. china, guangzhou, china (people's republic); b division of rheumatology, duke molecular physiology institute, duke university school of medicine, durham, usa introduction: extracellular vesicles (evs) have emerged as key indicators and effectors of ageing. although plasma concentrations of evs decline with age, the ev biomarkers associated with ageing and longevity are not fully understood. recently, our group found an age-related decline of plasma evs associated with immune cells during normal human ageing. our study aims to evaluate the association of plasma evs with longevity. methods: plasma samples were selected from the established populations for epidemiologic studies of the elderly study subjects (n = ): half dying within years (short-lived group) and half surviving ≥ years (long-lived group) after the blood draw; all matched for age (median age . ± . years, range - ), gender ( % female), and race ( % white/ % black). the samples were acquired under donor consent and irb approval of duke university. evs were separated from the plasma samples, and profiled based on the surface markers of haematopoietic stem cells (hscs), mesenchymal stem cells, immune cells, skeletal muscles, cardiac muscles and adipocytes (cd , cd , cd , cd , cd , cd , cd , cd , cd , cd , cd , cd a, cd a, cd , cd , hla-abc, hla-g, hla-drdpdq, cd , cd , cd , m cadherin, ryr , ryr , fabp , dlk ). the percentages of evs expressing each tested molecule were determined using a high-resolution multicolour bd lsr fortessa x- flow cytometer as we recently reported. graphpad prism . software was used for statistical analysis. results: we found significantly increased percentages of cd +, hla-abc+, cd + and cd a+ large evs ( - nm) in the long-lived compared to the short-lived group. none of the tested surface marker expressing medium ( - nm) or small (< nm) evs showed differential percentages between the shortand long-lived groups. summary/conclusion: evs carry surface markers from their parent cells. cd is expressed by hscs and immune cells. cd regulates homing of human cord blood cd + hscs, and delivers a potent cd independent costimulatory signal to activate t cells. hla-abc, the key human immunogen, is expressed by nucleated cells and platelets. cd is expressed by hscs, immune cells and epithelial cells, and cd + plasma evs declined with age in healthy people. cd a is expressed by hscs, megakaryocytes and platelets, and is functionally relevant for hsc maintenance and haematopoietic homoeostasis. our preliminary data suggest that hscs and immune cell associated plasma evs (cd +, hla-abc+, cd +, cd a+ large evs) inform on health status related to longevity. introduction: it is anticipated that stem/progenitor cells-derived extracellular vesicles (spc-evs) will rapidly progress towards clinical studies, and the development of reproducible, efficient, scalable and costeffective process for their production is expected to boost the therapeutic applications of evs-based products. in addition, the use of defined serum-/xenogeneic(xeno)-free culture medium formulations could result in substantial improvements for spc-evs production in terms of reproducibility, stability and quality, while ensuring the approval of regulatory agencies. the main goal of this work is to develop a full-controlled manufacturing platform for the spc-evs production. methods: human mesenchymal stromal cells (msc) were expanded in a xeno-free microcarrier-based bioreactor culture system operating in fed-batch feeding mode and after days the conditioned medium was collected. different methods for spc-ev isolation/purification from the msc-derived conditioned medium, including chromatography were compared and the the quality of the final product obtained was characterized by different methods according to misev, including nanoparticle tracking analysis, lipidomics and western blot. moreover fourier-transform infrared (ftir) spectroscopy was evaluated in terms of its implementation as a standard technique for the identification and characterization of evs. results: after days of msc expansion under dynamic conditions, we collected . l of conditioned medium with approximately . million evs/msc. a combination of a pretreatment with a nuclease for the digestion of dna/chromatin with a purification using strong anion exchange chromatography led to the best results so far in terms of evs isolation. of notice, by ftir spectroscopy, it was possible to define ratios of spectral bands, that can be used as biomarkers, enabling the discrimination of evs chemical fingerprint in function of the culture conditions tested. summary/conclusion: the platform established herein could be applied to the production of wellcharacterized spc-evs targeting their biomedical use in different settings (e.g. as drug delivery systems), as well as evs from other parental cells lines (i.e. dendritic cells) in therapeutic settings as cancer. ultrasensitive protein detection for quantification of extracellular vesicles in human biofluids enables comparison of isolation techniques dmitry ter-ovanesyan, maia norman, wendy trieu, roey lazarovits, george church and david walt wyss institute, boston, usa introduction: extracellular vesicles (evs) are released by all cells into biofluids and hold great promise as reservoirs of disease biomarkers. one of the main challenges in studying evs and using them in diagnostics is a lack of suitable methods to quantify evs that are sensitive enough and can differentiate evs from similarly sized lipoproteins and protein aggregates. we propose using ultrasensitive single molecule array (simoa) assays to quantify evs by immunoisolating and detecting ev transmembrane proteins in microwell arrays. we developed single molecule array (simoa) assays using the quanterix hd-x analyser for the quantification of evs using the tetraspanins cd , cd , and cd . simoa allows for the detection of single proteins using arrays of femtoliter wells, turning elisa into a digital immunoassay. we then used these assays, together with an additional assay for albumin, to compare commonly used ev isolation methods from plasma and cerebrospinal fluid (csf): ultracentrifugation, precipitation (exoquick), and size exclusion chromatography (sec) using the izon qev columns. we further used these assays to rapidly optimize and improve sec by comparing different sec resins and column dimensions in both plasma and csf. results: in comparing our simoa assays to traditional elisa with the same antibodies, we found that the simoa assays were more than times more sensitive, detecting the tetraspanins in samples where the proteins were undetectable by elisa. given the high dynamic range and high-throughput capabilities of simoa, we were able to comprehensively compare relative ev yields and ev purity for different isolation methods of evs from plasma and csf. we provide average tetraspanin and albumin levels to directly compare the methods. we also tested different sec resins and provide data for custom sec columns that outperform izon qev and allow for fine tuning of different ratios of evs to albumin. summary/conclusion: our results highlight the utility of quantifying evs using ultrasensitive simoa assays for tetraspanins. we were able to rapidly simoa to rapidly evaluate different ev isolation methods in csf and plasma. in general, the experimental framework we present could be easily applied to evaluate new ev isolation methods, or applied to any other biological fluid. thus, we think simoa is a powerful new tool for relative ev quantitation. introduction: the protein profile of extracellular vesicle (ev) subpopulations has been shown to contain valuable disease information, notably in cancer. currently, techniques aiming to find ev proteins that associate together mainly focus on transmembrane proteins, while methods that also probe cytosolic proteins generally resort to a combination of affinity capture, elution, and lysis, which limits throughput. to allow the high-throughput analysis of both membrane and cytosolic ev proteins, we optimized a total extracellular vesicle antibody microarray (tevam) incorporating fixation and heat-induced epitope retrieval (hier), then leveraged it to perform combinatorial protein profiling of evs from colorectal cancer (crc) cell lines ht and sw . methods: arrays of iggs targeting surface protein markers were incubated overnight with evs purified from cancer cell line supernatants. hier optimization was carried out through variation of buffer contents, presence or absence of prior permeabilization, as well as incubation time and temperature, for a total of conditions. a evs, previously profiled with other methods, were used as a model during the optimization. cytosolic protein hsp and membrane marker egfr, both with high expression in a evs, were probed and the results used to compare hier conditions. following hier treatment, protein targets were detected through incubation with primary antibodies and fluorescent secondary antibodies or streptavidin. the resulting optimized tevam workflow was used to phenotype ht and sw evs through probing of trios of surface ( ) and internal ( ) protein targets. results: the selected tevam protocol successfully maximized hsp signal while minimally affecting egfr detection, enabling simultaneous analysis of surface and internal proteins. profiles of more than combinations, featuring integrins, claudins, cytokines, and other key actors of cancer-relevant pathways, were obtained for ht and sw evs, revealing coexpression patterns that highlight the biomolecular heterogeneity both within and between crc cell line evs. summary/conclusion: using tevam, intra-and extravesicular proteins can be detected simultaneously in evs immobilized based on surface protein content, yielding extensive combinatorial protein profiles with significance for health and biomarker research. characterization of evs using orthogonal techniques identifies discrete ev populations from a mouse dendritic cell line bryce killingsworth a , timothy traynor b , joshua a. welsh c , aleksandra dakic a , jason savage a , kevin camphausen d , kenneth aldape a and jennifer jones a a laboratory of pathology, national cancer institute, national institutes of health, bethesda, usa; b laboratory of pathology, national cancer institute, national institutes of health, gaithersburg, usa; c laboratory of pathology, national cancer institute, national institute of health, bethesda, usa; d radiation oncology branch, national cancer institute, national institutes of health, bethesda, usa introduction: extracellular vesicles (evs) have the potential to serve as valuable biomarkers for patient response to cancer therapy. however, development of robust ev-based clinical assays relies on knowledge of ev concentration and diameter distribution. many different methods exist to measure the size and concentration of evs, and each method exhibits strengths and limitations. it is important to use orthogonal methods for determination of these important properties of ev preparations. here, we use dendritic cellderived evs to demonstrate that some ev analysis methods can give a biased interpretation of both diameter and concentration. through comparison, we highlight why orthogonal assays are essential in providing measurement reliability. methods: dc . mouse dendritic cells were cultured in flasks containing a total of . l of ev-depleted media ( % fbs, centrifuged hr. x , g.) when cells reached % confluency, conditioned media was collected, depleted of debris with two min. x , g spins, and concentrated down to~ ml using a pall jumbosep kda mwco filter. the ev concentrate was purified from protein using an izon qev- column, with ml fractions collected. the protein content of the ev-containing fractions was analysed by a , pierce bca, and bioanalyzer. the diameter distribution of the evs was determined by nanoparticle tracking analysis (nta), resistive pulse sensing (rps), flow cytometry (fcm), and electron microscopy (em.) concentration was compared using nta, rps, and fcm. evs were further analysed by protein mass spectrometry and rna sequencing. results: we have identified two distinct populations of evs with our dc . preparation, one highly abundant population with a power-law distribution, whose peak diameter is below nm, and a second, less abundant population with a peak diameter at approximately nm. these two distinct populations and their relative concentration were not detectable with all analysis techniques. based on cross-platform measurements, these populations appear to have distinct compositions that warrant further investigation. summary/conclusion: the use of orthogonal methods allowed the detection of two discrete populations of evs which was not possible on some platforms and would have resulted in a biased perspective of the sample composition. this work has highlighted the need for orthogonal measurements to be conducted by pairing techniques that do not have the same biases. introduction: extracellular vesicles (evs) are nanosized vesicles shed by all cells that serve vital roles in cell-to-cell communication. tumour-associated ev subpopulations vary in molecular content (lipids, proteins, nucleic acids, small molecules), enabling minimally invasive spectroscopic analysis for a wide variety of cancers. here, we use surface-enhanced raman spectroscopy (sers) in combination with a novel plasmonic substrate for global chemical composition analysis of cancerous and non-cancerous populations of evs to determine distinguishing surface characteristics. methods: evs were isolated from ovarian cancer (ovca) patient serum samples by differential ultracentrifugation. a new hybrid nanoplasmonic scaffold comprised of a microscale biosilicate diatoms embedded with silver nanoparticles (agnps) was used for sers measurements. the substrate was incubated with cysteamine to positively-charge the agnps (responsible for the sers enhancement) so that evs could attach (evs are naturally anionic). in a typical experiment, μl of~ particles/ml evs per sample were incubated with the porous substrate surface, which was inverted on a glass cover slip for raman interrogation. principle component analysis (pca) was used to compare the spectra and determine distinguishing characteristics between populations from tumour and non-tumour sources. we also trypsinized evs before sers analysis to see the extent of influence the surface molecules play in localizing the evs to the agnp "hot spots." results: a total of clinical samples ( ovca and non-malignant control) were tested in combination with ovca skov- cell line evs. simple pca was able to separate clinical samples according to disease subtype and major peaks were identified to provide chemical content analysis. each sample exhibited inherent heterogeneity but clustered together in a distinguishable way from the others. summary/conclusion: despite innate heterogeneity within single samples (i.e., evs isolated from a single patient sample), evs isolated from clinical samples could be easily distinguished from each other using our hybrid sers substrate, with minimal sample processing, a label-free approach, and only a few microlitres of sample. our study using this novel plasmonic material demonstrates its potential for use as a component in next-generation diagnostic platforms. introduction: single-particle analysis is critical for understanding extracellular vesicle (ev) heterogeneity. yet such techniques remain technically challenging due to low detection sensitivity and presence of variable amounts of "contaminants," including lipoproteins. the high degree of structural similarity between evs and lipoproteins in size, density, and chemical composition, results in their co-isolation using any of the standard ev isolation techniques. here we introduce laser trapping raman spectroscopy (ltrs) as a wellsuited, label-free, and non-destructive tool to distinguish evs from various lipoprotein species at single particle resolution. methods: ev samples were isolated from skov- cell culture supernatant by differential ultracentrifugation and their raman spectra measured. as the most abundant lipoproteins in ev isolations from human biofluids are sub-micron low density lipoprotein (ldl), very low density lipoprotein (vldl), and high density lipoprotein (hdl) particles, these were purchased as pure components and also measured by ltrs. ldl and vldl were then spiked-in to isolated evs to mimic "contaminated" post-isolation ev samples. raman spectra were analysed by principal component analysis (pca) using a custom matlab script. results: ldl and vldl have been observed to adhere to ev surfaces in vitro after standard isolation techniques. we could readily distinguish pure vldl, ldl, and hdl standards according to their raman spectra. pca revealed distinction of skov- evs from both ldl and vldl. pca also differentiated skov- evs incubated with ldl from skov- evs incubated with vldl. extent of ldl and vldl adherence to evs could be observed and quantified. summary/conclusion: through raman and pca, classes of lipoprotein and evs can be identified and quantified when co-incubated. ltrs is a quantitative single-ev analysis technique that can be used to differentiate between lipoprotein classes and evs when incubated together. this technique allows for analysis of evs where standard isolation methods fall short. introduction: extracellular vesicles (evs) are endogenous membrane-derived vesicles that shuttle lipids, proteins or nucleic acids between glia and neurons, thereby promoting neuronal survival and plasticity in the cns and contributing to neurodegenerative conditions. although evs hold great potential as cns theranostic nanocarriers, the specific molecular factors that regulate neuronal ev uptake and release are currently unknown. methods: we used a combination of patch-clamp electrophysiology and ph-sensitive dye imaging to examine stimulus-evoked ev release in individual neurons in real time. results: whereas spontaneous electrical activity and the application of a high-frequency stimulus (hfs) induced a slow and prolonged fusion of multivesicular bodies (mvbs) with the plasma membrane (pm) in a subset of cells, the neurotrophic factor bfgf (basic fibroblast growth factor) greatly increased the rate of stimulusevoked mvb-pm fusion events and, consequently, the abundance of evs in the culture medium. proteomic analysis of neuronal evs demonstrated bfgf to increase the abundance of the v-snare vesicle-associated membrane protein (vamp , cellubrevin) on evs. conversely, knocking-down vamp in cultured neurons attenuated the effect of bfgf on ev release. introduction: heat shock proteins (hsps) function as chaperones under both normal and pathologic conditions. as chaperones they assist in protein folding, in holding protein complexes for current or future activation, and in degradation of senescent proteins for recycling of components and display for immune surveillance. during stressful situations, hsp quantities and/or activities increase as cells and tissues seek protection from insults. these insults can result in the cell surface display of hsps, which can then lead to the surface display of hsps on extracellular vesicles (evs). hsps present on the cell surface or in the extracellular space are regarded as "danger signals" in an ancient biologic paradigm. hsp-accessorized evs may act as "danger boli", carrying not only the hsps, but hundreds of components of the stressed parental cell, capable of prompting differential responses depending on the status of the recipient cell. methods: clarified/filtered plasma from patients suffering from neurologic maladies (cancer, brain injury, multiple sclerosis) was incubated with peptides designed to bind hsps. the evs congeal under these conditions and are pelleted (microfuge) and washed with increasing-stringency buffers. we lysed the evs and subjected them to metabolomic analyses (focused on lipids) or assayed them on phosphokinase arrays. results: we show that evs from the blood of patients suffering from brain tumours, or from tbi, or from ms, possess distinct metabolomes compared to blood evs from healthy donors. we found hundreds of differentially-expressed lipids amongst the patients vs the healthy donors. the levels of annotation and identification for these compounds ranges from level (low, no matches in databases) to level (high, annotation matches to known database components). in addition, we found differences in phosphorylated kinases as cargo in these evs between patients with matched primary vs recurrent gliomas, and among tbi/stroke patients compared to healthy donors. summary/conclusion: hsp-accessorized evs present different metabolomic and phosphokinase content which may serve as biomarkers in a "liquid biopsy" setting, but may also play roles in the pathobiology of neurologic diseases. introduction: methamphetamine (ma) has deleterious effects to both peripheral organs and the central nervous system. the rewarding properties and addictive potential of ma are correlated with increased synaptic dopamine availability following alterations in dopamine and vesicular monoamine transporter function. in rodents, ma alters brain mirna expression and the mirna content of serum extracellular vesicles (ev). here we examined plasma evs isolated from human subjects actively using ma (ma-act) for size, concentration, protein markers, and mirna content. methods: plasma samples from ma-act, and controls (ctl) were obtained from the methamphetamine abuse research center. plasma evs were evaluated by vesicle flow cytometry (vfc) for size, concentration, and surface protein markers. vfc antibodies included markers for a pool of tetraspanins (cd , cd , and cd ), platelet evs (cd ), pro-coagulant evs (annv), and red blood cell evs (cd ). next plasma ev isolated by size exclusion chromatography were analysed by qpcr on taqman® array human microrna a + b card set v . . fold change was calculated by ΔΔcq between ma-act and ctl for mirna expressed in ≥ % of samples in at least group. we identified the top % of ranked mirna by fstatistic; of these, the mirna of interest for ma-act were identified by at least a (i) . fold change in expression, (ii) area under the receiver operating characteristic curve of . , and (iii) glass's Δ of . for mirna of interest correlations to additional ma variables were conducted, along with ingenuity pathway analysis of predicted gene targets. tobacco use was controlled for. results: vfc data show that the size (~ nm) and concentration (~ . x particles/ml) of all plasma evs is comparable between ma-act and ctl groups. in addition, the plasma evs primarily consist of tetraspa-nin+, annv+, or cd + evs, and to a much lesser extent cd + evs. of the mirna expressed in ma-act and/or ctl plasma evs, there were mirna that have at least a . fold increase or decrease in ma-act. mirna were identified to be of interest in ma-act based on fold change, effect size and diagnostic potential, compared to ctl. further, of the mirna correlate with a ma associated variable, including frequency of use and age of first use. together the mirna best cluster subjects based on ma-act status, not tobacco use. finally, the predicted gene targets of the mirna are associated with canonical pathways linked to ma. summary/conclusion: ev mirna expression in ma-act subjects was unique to ctl participants, suggesting that ma may affect ev communication among cells. the differential mirna expression also implicates a role for evs in behavioural and physiological effects specific to ma, and suggests that there may be changes in expression of mirna that are relevant to specific drugs of addiction, as well as to a spectrum of drug-mediated addiction disorders. bone marrow-derived extracellular vesicles may alter the ageing phenotype of murine haematopoietic stem cells. sicheng wen a , jill kreiling b , mark dooner c , elaine papa c , michael del tatto c , yan cheng c , mandy pereira c , peter quesenberry c and laura r. goldberg d in natural ageing of haematopoietic stem cells (hscs) is unclear. we tested the hypothesis that bone marrowderived evs (bm-evs) can modulate the ageing hsc phenotype. methods: we flushed bone marrow from old ( - month old) and young ( - -week old) c /bl mice and collected bm-evs by differential centrifugation ( × g for min, supernatant collected and centrifuged , × g for hour, bm-ev pellet collected and quantified by nanoparticle tracking analysis). we injected old mice with x ^ young bm-evs via tail vein, daily x days. control mice were injected with age-matched bm-evs or vehicle alone. we euthanized the mice one month post-injection, harvested whole bone marrow (wbm) and highly purified hscs (lineage negative/c-kit+/sca- +/cd +; lsk-slam) and tested stem cell function in competitive bone marrow transplants ( - recipients/group). results: at months post-transplant, wbm from old mice exposed to young bm-evs exhibited a statistically significant decrease in engraftment when compared to wbm exposed to age-matched bm-evs (percent average donor chimerism ± sem: % ± % (young evs) vs. % ± % (old evs)). for lsk-slam from old mice, we observed a trend towards decreased engraftment when exposed to young bm-evs and a trend towards increased engraftment potential when exposed to old bm-evs (percent average donor chimerism ± sem: % ± % (young evs), % ± % (old evs), % ± % (vehicle)). these findings are consistent with our previous data showing that, in contrast to highly purified hscs which develop impaired stem cell function with ageing, total un-separated old wbm actually has increased engraftment capacity when compared to young wbm. of note, we found that the classic myeloid skewing by old lsk-slam was partially reversed by exposure to both young and old bm-evs. finally, consistent with the known increase in highly purified hscs with age, our preliminary data showed that old mice exposed to young bm-evs had an approximately -fold decrease in the number of lsk-slam cells in marrow, indicating that bm-evs may influence agerelated changes in hsc number. summary/conclusion: these preliminary data suggest bm-evs may play a role in modulating hsc ageing phenotypes, potentially altering engraftment capacity, lineage fate, and lsk-slam population size. future studies delineating the molecular mechanisms underlying these ev-mediated effects could provide key insights into normal haematopoietic ageing. funding: this work was supported by the nih grants p gm , dk - a and by the savit foundation. oral with poster introduction: brain extracellular vesicles (evs) are heterogenous and include previously described microvesicles and exosomes. herein we characterized a formerly unappreciated population of mitochondriaderived evs that we term "mitovesicles". mitochondrial dysfunction is a well-established hallmark of ageing and neurodegenerative disorders as down syndrome (ds). hence, we examined mitovesicle levels and cargo under these conditions to characterize in vivo mitovesicle biology and responsiveness to mitochondrial stressors. methods: employing a high-resolution density gradient, distinct and novel populations of evs were isolated from murine and human ds and diploid control postmortem brains or from cell media. morphometric ev features were analysed by nanoparticle tracking analysis and cryogenic electron microscopy, while ev constituents were characterized by western blotting, mass spectrometry, lipid profiling and mitochondrial rna qpcr. results: we identified a population of double-membrane, electron-dense brain evs containing multiple mitochondrial markers ("mitovesicles") that are highly distinct from microvesicles and exosomes. proteomic data show that mitovesicles contain a unique subset of mitochondrial proteins while lacking others, such as tom . mitovesicles have a lipid composition that is unlike that of previously described evs and is consistent with mitochondrial origin. functionally, the complex-iii inhibitor antimycin-a stimulated in vitro mitovesicle release into the cell media, suggesting an interrelationship between mitochondrial dysfunction and mitovesicle biology. in mouse brains, mitovesicle levels increased with age and were found to be higher in ds compared to diploid controls. mitochondrial rna and protein levels were also altered in ds compared to diploid controls. summary/conclusion: we describe a previously unidentified type of metabolically competent evs of mitochondrial origin that we designate mitovesicles. our data demonstrate that brain mitovesicle levels and cargo are tightly regulated in normal conditions and are modified during pathophysiological processes in which mitochondrial dysfunction occurs, suggesting that mitovesicles are a previously unrecognized player in mitochondria quality control and may have a role in the trans-cellular tissue response to oxidative stress. introduction: alzheimer's disease (ad) is a devastating neurodegenerative disease leading to progressive memory loss and ultimately death with limited therapeutic options. growing evidence supports the theory that toxic proteins, like tau and amyloid, may propagate from diseased cells by packaging toxic proteins into extracellular vesicles (evs) and releasing them to infect other cells. one enzyme involved in the biogenesis of evs is neutral sphingomyelinase (nsmase ), which catalyzes the hydrolysis of sphingomyelin to produce phosphorylcholine and ceramide. several groups have reported improved cognition and reduced tau propagation when nsmase is pharmacologically inhibited or genetically knocked down in ad mouse models. unfortunately, current nsmase inhibitors are not suitable for clinical development due to poor solubility and inadequate pharmacokinetic profiles. methods: our group carried out a high-throughput screening campaign followed by extensive medicinal chemistry efforts leading to the discovery of phenyl (r)-( -( -( , -dimethoxyphenyl)- , -dimethylimidazo [ , -b] pyridazin- -yl) pyrrolidin- -yl) carbamate (pddc), an orally active, nm potent inhibitor with excellent selectivity and brain penetration. we tested pddc's ability to inhibit exosome release in cultured primary glial cells as well as an in vivo model of acute ev release. we then treated xfad mice with mg/ kg of pddc daily for six months and monitored their behaviour in the fear conditioning assay. results: pddc dose dependently reduced ev release from cultured primary glial cells and significantly reduced plasma ev numbers in an in vivo model. following chronic treatment with pddc, xfad mice demonstrated significantly improved cognitive function in the fear conditioning assay. summary/conclusion: these promising findings are currently being expanded using mouse models of tau propagation. if successful, these data would support pddc as a novel compound for targeting the pathological spread of tau as a therapeutic for ad. profiling evs in the anterior cingulate cortex of individuals with major depressive disorder introduction: major depressive disorder (mdd) is one of the leading causes of disability worldwide, affecting % of the population. the environment has been thought to play a role in the disease development, resulting in biological changes mediated by epigenetic mechanisms. microrna's (mirna) are well known epigenetic regulators that are disrupted in the depressed brain, and they are packaged into extracellular vesicles (evs). evs have emerged as means of intercellular communication, a process that is also disrupted in mdd. they are thought to transfer mirna between cells, which can alter gene expression in recipient cells. therefore, we hypothesize that ev cargo is altered in mdd subjects compared to healthy controls (hc). the aim is to extract evs from human post-mortem anterior cingulate cortex, a region previously associated with depression, and profile the mirna cargo and compare it between mdd subjects and hc. methods: post-mortem human brain tissue from the anterior cingulate cortex of mdd subjects and hc was mildly dissociated in the presence of collagenase type iii. residual tissue, cells, and large vesicles were eliminated, and evs were isolated using size exclusion chromatography. the quality was assessed by western blots and transmission electron microscopy (tem). rna was extracted and a small-rna library was constructed and sequenced using the illumina platform. differential expression analysis was then performed. results: western blots showed little to no endoplasmic reticulum (calnexin), golgi (bip), or mitochondrial (vdac) contamination, along with enrichment of the exosomal marker cd . tem images showed the typical cup-shaped morphology with sizes mostly between and nm. preliminary sequencing results revealed that mir- a- p, which is predicted to target glutamate receptors, is downregulated in evs from mdd subjects. summary/conclusion: high quality ev extractions can be obtained from post-mortem brain tissue using our method. this will be the first study to profile brainderived ev mirna in the context of depression. future studies will be needed to determine the effect of the different levels of mir- a- p. this could provide novel mechanistic insights into the pathophysiology of mdd and will serve as a starting point to examine the potential role of evs in mdd pathology. op . = ps . combining nanomagnetic isolation and artificial intelligence to guide the treatment of traumatic brain injury zijian yang a , kryshawna beard b , david meaney b , danielle sandsmark b , ramon diaz-arrastia a and david issadore c a university of pennsylvania, philadelphia, usa; b university of pennsylvania, philadelphia, usa; c department of bioengineering, university of pennsylvania, philadelphia, usa introduction: traumatic brain injury (tbi) is characterized by diverse primary mechanisms of injury that lead to the development of secondary pathological cascades that drive neurological deficit post-tbi. inability to separate patients based on the presence of these different endophenotypes represents a major challenge for diagnosis and treatment of tbi. extracellular vesicles including exosomes isolated from patient plasma have emerged as promising potential biomarkers for tbi due to their ability to cross the bbb into systemic circulation with molecular cargo intact for analysis. we have developed a novel microfluidic platform for rapid isolation of brain-derived evs providing a tool with which the biochemical state of neurons and glia can be directly assessed post-tbi. we used the ultra-sensitive, single molecule array (simoa) to quantify concentrations of protein biomarkers from the plasma and brain derived evs from mild tbi patients and controls. by combining multiple protein biomarkers, we could discriminate mtbi patients from controls in both the training and the blinded test set. building on this work, we are also characterizing single ev heterogeneity of neuron derived evs by developing novel droplet based digital assay for single ev quantification at ultra-low concentration. droplet based assay for single ev analysis would potentially be very informative for early disease diagnosis and therapy decision. methods: our microfluidic platform for ev isolation consists of tracked-etched membranes with millions of nanopores ( nm), coated with a magnetic film (nife) to precisely capture immunomagnetically labelled brain-specific evs from plasma. single molecule array (simoa) was used to quantify concentrations of the protein biomarkers (tau, uchl- , nfl, gfap, il , il , and tnf) in the plasma and brainderived exosomes of mild tbi (mtbi) patients and controls. to identify single ev, we applied droplet based enzyme-linked immunosorbent assay and encoded the fluorescent signal for single ev quantification within parallelized microfluidic platform. results: we report that concentrations of plasma and exosome gfap, nfl, and uchl were elevated in mtbi patients compared to controls (p < . ), and that each of these biomarkers are uncorrelated with one another. discrimination of mtbi patients from controls was most accurate when machine learning algorithms on the panel of biomarkers. specifically, combining plasma nfl, gfap, il and tnf-with tau from glur + evs showed % accuracy with % sensitivity and % specificity. summary/conclusion: this data suggests that neuronderived exosomes contain information that characterizes the injured and recovering brain. it also suggests that analysis of a panel of biomarkers from a combination of both blood and exosomal compartments could lead to more accurate diagnosis of mtbis. l cam is not associated with extracellular vesicles in cerebrospinal fluid or plasma wyss institute, boston, usa introduction: neurons in living psychiatric and neurological patients are inaccessible for cell type specific analysis of rna and protein. our understanding of these diseases instead relies upon imperfect sources of biochemical information such as post-mortem brain tissue analysis and animal models. furthermore, there is a paucity of biochemical assays available to diagnose and manage brain diseases. extracellular vesicles (evs) present an opportunity to noninvasively sample the contents of neurons in cerebrospinal fluid (csf) and plasma. in order to isolate neuron-derived evs (ndevs), a cell type specific transmembrane protein is necessary for immunocapture. l cam, a protein abundant on the surface of neurons, has been used extensively in the literature for ndev isolation. however, l cam exists in humans in several isoforms without a transmembrane domain, and as such it can be secreted as a free protein. additionally, the ectodomain of l cam can be cleaved off of the cell surface in physiological processes. it remains to be demonstrated whether the l cam found in csf and plasma is ev associated, or if it is instead a spliced or cleaved isoform behaving as a free protein. methods: using single molecule arrays (simoa), a digital form of elisa, as well as western blotting, we quantify ev markers (cd , cd and cd ) as well as l cam and albumin. we use these assays to determine in which fractions of size exclusion chromatography (sec) and density gradient the l cam appears. we also immunocapture l cam from csf and plasma and perform western blots for the internal and external domains of l cam. results: simoa and western blot analysis of sec and density gradient fractions demonstrated that while the ev markers peaked all together, l cam eluted in the free protein fractions along with albumin in both csf and plasma. when immunoprecipitation was performed, western blotting revealed different isoforms of l cam in csf and plasma. summary/conclusion: our data utilize a multitude of distinct techniques that converge to demonstrate that l cam is not associated with evs in csf or plasma. furthermore, our data suggest that the isoforms present in csf and plasma are distinct, which indicates that the l cam in plasma is likely not coming from the brain. this data call into question the utility of l cam as a ndev marker and point to the need to find novel candidates for immunoprecipitation of ndevs. introduction: in parkinson's disease (pd), α-synuclein (α-syn) aggregates known as lewy bodies (lb) are present in both the central and peripheral nervous system. furthermore, data showing that α-syn can spread from pd patients to transplanted tissue has led to a new theory postulating that pathological forms of α-syn can drive disease by "infecting" healthy cells and corrupting normal proteins. the exact routes and mechanisms involved in such spreading are yet to be fully understood but it is known that α-syn can be secreted from cells and transported via extracellular vesicles (ev). ev derived from erythrocytes (eev) are of particular interest in this regard as they have been shown to contain α-syn. methods: we first optimized a protocol for the isolation of fluorescently labelled human eev. the capacity of these eev to cross the blood-brain barrier (bbb) was then evaluated in vitro using a boyden chamber composed of primary human brain endothelial cells. next, eev were added to a more complex and physiologically relevant d human bbb model including ipsc-derived brain microvascular endothelial cells. in both in vitro protocols, flow cytometry was performed on media collect from each compartment to determine the number of eev. immunofluorescence was performed to assess the localization of fluorophore tagged eev. we are also using an in vivo paradigm for the extraction and testing of eev spread and an in situ cerebral perfusion (isbp) model in wt mice to investigate if and how eev cross the bbb using confocal microscopy. results: in both in vitro models, flow cytometry analyses showed that fluorescently tagged eev added to the luminal side traversed the endothelial cell barrier. confocal analysis revealed that some eev could also be found within endothelial cells themselves. ongoing experiments are being conducted in our newly developed d bbb to further confirm these results. our preliminary in vivo experiments showed that fluorescently labelled beads, similar in size to eev, used in the isbp experiments are detectable in the brain parenchyma of injected wt mice using confocal microscopy. preliminary work also includes isbp injections of eev in -month-old wt mice, (n = /groups) derived from pd patients (at different stage of the disease) and a healthy individual as a control. summary/conclusion: our preliminary data suggests that eev can indeed move across the bbb in both in vitro and in vivo experimental setups. ongoing experiments will determine the dynamics and processes involved in this transport and whether eev can precipitate and/or exacerbate disease-related features. introduction: neuroblastoma accounts for % of childhood cancer mortality. amplification of the oncogene n-myc is a well-established poor prognostic marker for neuroblastoma. whilst n-myc amplification status strongly correlates with higher tumour aggression and resistance to treatment, the role of n-myc in the aggressiveness of the disease is poorly understood. exosomes are released by many cell types including cancer cells and are implicated as key mediators in cell-cell communication via the transfer of molecular cargo. hence, characterising the exosomal protein components from n-myc amplified and non-amplified neuroblastoma cells will improve our understanding on their role in the progression of neuroblastoma. methods: in this study, comparative proteomic analysis, nanoparticle tracking analysis, transmission electron microscopy, rnai-based knockdown, migration and cellular survivability assays were performed to understand the role of exosomes isolated from cells with varying n-myc amplification status. results: label-free quantitative proteomic profiling revealed proteins that are differentially abundant in exosomes released by the n-myc amplified and nonamplified neuroblastoma cells. gene ontology-based analysis highlighted the enrichment of proteins involved in cell communication and signal transduction in n-myc amplified exosomes. treatment of less aggressive sh-sy y cells with n-myc amplified sk-n-be cell-derived exosomes increased the migratory potential, colony forming abilities and conferred resistance to doxorubicin induced apoptosis. incubation of exosomes from n-myc knocked down sk-n-be cells abolished the transfer of resistance to doxorubicin induced apoptosis. summary/conclusion: these findings suggest that exosomes could play a pivotal role in n-myc-driven aggressive neuroblastoma and transfer of chemoresistance between cells. op . = ps . introduction: quantification and characterization of single extracellular vesicles (sevs) based on surface markers can aid in dissecting the heterogeneous landscape of ev subpopulations. we and others have demonstrated the potential of imaging flow cytometry (ifc) to perform sev characterization. we recently showed release of protoporphyrin (ppix) positive sevs by -aminolevulinic acid ( -ala) dosed glioma cells, in vitro and in vivo. rickfels et al. also used ifc to demonstrate the enrichment of cd +/cd + evs in the plasma of glioma patients. herein, we performed in vitro studies to characterize ev subfractions using -ala as well as ev and cns specific surface markers. methods: we use ifc to characterize evs released by glioma using -ala, fluorescently labelled ev (cfda-se, cd ) and glioma specific (tenascin c and epidermal growth factor receptor viii, egfrviii) markers. furthermore, we characterized evs released by egfrviii positive glioma cells treated with dexamethasone, a steroid commonly used in glioma patients, to determine the effect of steroids on ev release. evs were quantified by ifc and results were confirmed by qpcr for the levels of egfrviii mrna. results: firstly, we optimized protocols to label glioma sevs using fluorescently labelled ev markers (cfda-se, cd ) and tumour specific markers (tenascin c and egfrviii). of the total evs (cfda-se), we demonstrate that % are tenascin c positive, . % are egfrviii positive and . % are -ala positive. there was only a minor overlap (< %) between the sub-populations. finally, we show that dexamethasone treated glioma cells release lower total evs ( . -fold), tumour specific evs ( . -fold; egfrviii), egfrviii mrna compared to mock treated cells. summary/conclusion: we demonstrate the potential of ifc to monitor sevs released by glioma cells exposed to different stimuli. this allows the characterization of ev sub-populations providing a working model to understand the dynamics of tumour evs at a single vesicle level. introduction: f. graminearum (fgr) and f. oxysporum f. sp. vasinfectum (fov) are severe fungal pathogens of cereals and cotton, respectively. fgr and fov cause economic losses and threaten food and fibre supplies worldwide. understanding host-pathogen interactions is crucial for developing new strategies for disease control. we are determining whether extracellular vesicles (evs) have a role in the interaction between fungal pathogens and their host plant. methods: we isolated evs from fgr and fov by sizeexclusion chromatography and characterized them by nta and tem. evs from fgr and fov are between - nm and have morphology similar to evs reported for other fungi. we performed label-free quantitative proteomics to describe the protein cargo of evs from fgr and fov, including a comparative study of evs from fov grown on different media: czapek dox (cd) and saboraud's dextrose broth (sdb). results: a total of proteins were detected in fgr evs and, according to prediction software effectorp, . % of these were potential effectors. similarly, % of ev proteins do not contain signal peptide indicating that packaging into evs is a novel mechanism of secretion for these proteins. notable fgr ev proteins include lipases, proteases and synthases for toxins and chitin. fov produced evs in similar quantities in both growth media tested, but ev protein cargo differed between them. there was a % overlap in proteins identified in the cd and the sbd ev proteins. in general, ev proteins were involved in metabolism, cell wall architecture and oxidoreduction, with . % and . % of potential effectors, respectively. polyketide and toxin synthases, proteases and effectors were present in both types of fov evs. summary/conclusion: this new fungal ev isolation method was rapid, yielded high-quality evs, and did not submit particles to high centrifugal forces. our data revealed that both fgr and fov produce evs enriched with proteins that could alter host immune responses or facilitate fungal infection. furthermore, the protein composition of fov evs was dependant on culture conditions. this supports a potential role for fungal evs in disease progression in plants and provides the foundations to pursue the role of evs in plant-fungal interactions with the potential to identify new targets for disease control. introduction: extracellular vesicles (ev) released by infective forms of trypanosoma cruzi, the agent of chagas' disease, modulate inflammatory response of macrophages through the activation of toll receptor (tlr ) via mitogen-activated protein kinase pathway. this induces the production of nitric oxide (no) and expression of the cytokines tnf-α, il- and il- , which could explain the inflammation observed in experimental chagas' disease, and eventually in the progression of human disease. evs released by the parasite are heterogeneous and it is unknown which factor, or factors present in the different vesicle populations act during the interaction with host cells. objectives. the goal of the present work was to characterize and isolate the different populations of evs released by t. cruzi and test their effects on macrophages. methods: ev released by trypomastigotes forms of t. cruzi (y strain) were purified by asymmetric flow fieldflow fractionation (af ) and characterized by nanoparticles tracking analysis (nta). the different populations of evs were incubated with host human monocytes cells (thp- ) and cytokines production determined by elisa and qpcr. the different ev populations were also incubated with llcmk- epithelial cells and the infection by t. cruzi determined. results: we found two distinct populations of evs. a population with to nm (ev ) and another with to nm (ev ). ev induced more tnf-alpha, il- , ip- and ccl than ev . it was also more effective in promoting t. cruzi infection in epithelial cells. summary/conclusion: t. cruzi released two ev populations that affects differently host cells. identification of these evs composition might help to better understand the role of evs in the modulation of t. cruzi infection funding: fapesp, cnpq and capes op . = ps . commensal bacterial extracellular vesicles act as carriers for norovirus sutonuka bhar, melissa jones, annalise galbraith and mariola edelmann university of florida, gainesville, usa introduction: human norovirus (hunov) are one of the most common causes of gastroenteritis and, along with inducing morbidity and mortality by diarrhoea, have a massive economic impact resulting in approximately usd billion each year in healthcare costs and missed worker productivity. development of anti-viral therapies for hunov has been hampered by the lack of robust in vitro cultivation systems. several cell types support viral replication but only produce modest amounts of virus due to unknown reasons, making these systems insufficient for use in drug development and infectivity assays. noroviruses are known to attach to gram-negative enteric bacteria and this facilitates infection in vitro. however, the microbiome-norovirus-host communication link is missing. noroviruses infect immune cells present in lamina propria during acute infection, but bacteria themselves are large enough to cross the mucosal and the tight epithelial barrier which separates gut lumen from lamina propria. we hypothesized that binding of noroviruses to bacteria enhances extracellular vesicles (ev) production. because commensal bacterial evs by themselves do not have any detrimental effects on host cells, we believe using evs in in vitro culture will enhance norovirus infection, thus producing higher titre of viruses for vaccine and anti-viral drug development. methods: attachment assay: purified norovirus was incubated with enterobacter cloacae, lactobacillus acidophilus and bacteroides thethiotaomicron, and grown to produce evs. the attachment was confirmed via qpcr. isolation of evs: clarified media supernatants were subjected to ultracentrifugation at varying speeds and . um filtration. co-purification of norovirus with the evs was checked. ev quantification and characterization: ev total protein content was measured by microbca. the number of vesicles were quantified by nanoparticle tracking analysis. scanning and transmission electron microscopy was performed to check quality of ev preparation and determine if virus was attached to the vesicles. internal ev protein content was evaluated using ms-hplc. the evs were also check for infectivity via tcid assay. results: incubation of noroviruses with commensal bacteria resulted in significant increases in production of evs compared to uninfected controls. murine norovirus (mnv), used as a surrogate, was found to be associated with evs. em analysis determine association of viruses with the bacteria as well as the mvs, while also showing certain surface structural changes in virus attached bacteria compared to mock bacteria. the evs were found to cause infection in naive macrophages. summary/conclusion: changes in ev production and content by bacteria exposed to noroviruses will provide insight into its pathogenesis and possible solutions to the low viral output from hunov culture systems. detection of bacterial extracellular vesicles in blood from healthy volunteers kylie krohmaly a , claire hoptay b , andrea hahn a and robert freishtat a a children's national hospital, washington, usa; b childrens national hospital, washington, usa introduction: bacteria constitutively produce biologically active extracellular vesicles (evs), which contain rna, dna, and/or proteins. bacteria use these evs for communication with other bacteria and recent research suggests bacterial evs can also affect host cells. given these findings, it is necessary to examine the role of bacterial evs in human disease. current methods of bacterial ev isolation from human specimens cannot distinguish between bacterial species. however, there is utility in examining evs from specific species, as bacterial species and their evs may have unique contributions to human disease. our objective was to isolate circulating evs specifically from escherichia coli (eevs) and haemophilus influenzae (hevs), two known colonizers and pathogens in the gut and airway, respectively. methods: total evs were isolated from the blood of six healthy volunteers via precipitation and size exclusion chromatography. evs were then selected via a novel latex bead-based fluorescent antibody construct targeting species-specific outer membrane proteins. we used flow cytometry to evaluate the isolated evs. results: the constructs were saturated with eevs at an antibody concentration of . µg/ml of plasma, as geometric means ≥ . µg/ml were nearly equal. hevs were detected at µg/ml of plasma, but saturation is yet to be determined. eevs were imaged by a fei talos f x electron microscope and measured between - nm, and hevs were between - nm. both types of evs were spherical. summary/conclusion: using this novel technique, we were able to isolate, detect, and visualize eevs and hevs. this technique enables the study of specific bacterial evs. in the future, ev contents will be assayed. furthermore, this technique will be modified so that specific bacterial evs from body fluids can be used for downstream functional applications. this is the first time that bacterial evs from targeted bacterial species have been detected in blood from healthy humans. introduction: new zealand (nz) has a population of just . million people with a remote geographical location in the pacific ocean. its unique culture, food-based industries and ethnic population make nz an invaluable place for extracellular vesicle research into all areas. however, as for many places in the world, standardization of methodologies, training and access to appropriate equipment is challenging. methods: the hub for extracellular vesicle investigations (hevi) is a virtual research centre established in with three-year seed funding from a university of auckland strategic research initiatives fund. two staff members are employed to support training, education and optimization of methods. the hevi is guided by a governance group providing valuable input from australasian experts in evs. results: since the hevi has organized research symposia, hands-on training days, hosted international students as well as providing one-on-one training for individuals from universities and institutes across nz. training is provided on multiple isolation and characterization methods and tailored to individuals access to essential equipment without bias towards individual manufacturers or techniques. travel funding has supported people to attend conferences and workshops for the purposes of education, networking and research dissemination. the hevi also provides support for project design with grants awarded to hevi members and a number of manuscripts in submission for publication. the embo practical course "extracellular vesicles: from biology to biomedical applications" is organized each year by a group of researchers active in the ev field in collaboration with the embl advanced training center in heidelberg. the course focuses on training phd students and postdoctoral researchers who enter or are already active in the field of ev research. given the large number of methods and protocols that is being used by researchers in the ev field, the organizers aim to provide practical guidance to new researchers and teach them appropriate skills. methods: participants obtain theoretical knowledge and hands-on experience on different ev purification and characterization techniques, such as fluorescent labelling, density gradient centrifugation, size exclusion chromatography, electron microscopy, flow cytometry and nanoparticle tracking analysis and on databases like ev-track and funrich. in addition, the organizers and invited lecturers from several different research areas explain which strategies are used to understand the role of ev in biomedical applications and give an overview of the current state of the field of ev research. results: the course therefore covers a broad range of topics important in the ev field, including heterogeneity in ev subpopulations, mechanisms of ev cargo selection, ev biogenesis, pre-analytical variables, therapeutic and diagnostic use of ev, and in vivo functions of ev. group discussions are facilitated and stimulated via assignments to analyse data obtained during the practicals and to critically evaluate literature. participants also have the opportunity to present their own research during poster presentations and ask for feedback from organizers and invited lecturers. summary/conclusion: among the participants selected for the course, a large geographical distribution is reached, including researchers from the newer eu member states and from outside of europe, to ensure a broad geographical distribution of the knowledge gained during this course. introduction: on october , we organized the st lugano exoday, first initiative in the southern switzerland to bring together resident researchers and european experts in the field of extracellular vesicles (evs). the workshop, centred on "technical challenges of extracellular vesicle research" aimed to highlight technical requirements and advances in the evs area, focusing on isolation, characterization and tracking. methods: the workshop started with a lecture by dr. cecilia lässer, from the university of gothenburg. the rest of the workshop was divided in two working groups (wg), each introduced by a keynote lecture followed by presentations by young researchers and a round-table discussion. wg , introduced by dr. mercedes tkach, from the institute curie in paris, focused on recent advances on evs characterization and isolation. wg was centred on evs tracking and introduced by dr. frédérik verweij, from the institute of psychiatry and neuroscience of paris. results: dr. lässer opened the workshop with a comprehensive review and introduced recent developments in the evs field. the first wg discussed different isolation methods, focusing on ultracentrifugation, size exclusion chromatography and immunoprecipitation-based techniques. supported by the keynote speakers, the participants agreed that the best approach to optimize the isolation process consists in the combination of different techniques. wg shared insights about new strategies to visualize and tracking evs, focusing on how to improve the routinely approaches used, defining optimal criteria for evs labelling and imaging. all the participants had an in-depth overview on the requirements and the state-of-the-art techniques currently in use for the isolation, characterization and tracking of evs. summary/conclusion: the transferable knowledge acquired during the workshop ensures participants to remain up-to-date with the advances in the field of evs. as our ultimate goal is to create a competence centre in southern switzerland around the field of evs, the workshop was an invaluable opportunity to intensify collaborations between resident laboratories and broaden the scientific exchange with laboratories of the experts hosted during the event. given the success of this first workshop we are already working to prepare the second edition and make the event a recurring appointment. funding: supported by the swiss national science foundation the role of core facilities and emerging technologies in maximizing rigour and reproducibility of ev quantification and characterization and following misev guidelines rachel derita a and andrew hoffman b a thomas jefferson university, philadelphia, usa; b university of pennsylvania school of veterinary medicine, philadelphia, usa introduction: it remains very clear in the field of extracellular vesicle (ev) research that the rapid rate of increase in publications and expansion of interdisciplinary clinical ev interest has created the need for increased standardization and access to the appropriate technologies to uphold these standards. as the first core facility in the usa with the sole intention of creating a space where users can both isolate and characterize evs, we provide a central location for the facilitation of ev research via access to multiple technologies (both established and emerging) such as resistive pulse sensing, nanoparticle tracking analysis, ultracentrifugation, high-performance liquid chromatography, flow cytometric analysis of evs and additional immune or fluorescence-based ev characteri zation techniques. methods: we surveyed a group of leading scientific investigators and researchers in varying stages of their scientific careers in the mid-atlantic region of the us. the survey data demonstrate applications of greatest current and future interest to be employed in a shared lab resource. results: the current demand is highest for isolation services, ultracentrifugation and nta, with a gradually increasing demand for immunophenotying analyses such as the exoview chip array, fluorescent nta and flow cytometry. we additionally present strategies and data-based examples of how shared resource facilities can facilitate multifactorial and rigorous ev characterization in accordance with misev guidelines, and encourage collaboration among ev researchers. summary/conclusion: in order to answer the larger remaining questions in the ev field such as the isolation of specific ev subsets, ev tracking between cells and the use of evs for biomarker discovery and drug delivery, it is essential that shared resource facilities interact not only with investigators, but with each other to integrate the necessary resources to progress. programme to assess the rigour and reproducibility of extracellular vesicle-derived analytes for cancer detection national cancer institute, rockville, usa introduction: cancer cells release more evs than normal cells and evs secreted from tumour cells can promote tumour progression, survival, invasion and angiogenesis. the ev cargo may mirror the altered molecular state of the cell of origin. therefore, evs have potential for the development of non-invasive markers for early detection of cancers. evs and their cargo also have the potential to be multiplexed with other molecular markers or screening modalities (e.g., imaging) to develop integrated molecular-based computational tools for the early detection of cancer. one challenge with using evs as a biomarker is the lack of robust and reproducible methods for the isolation of a pure vesicular population. there is a lack of clear consensus for an optimal method of isolation of a pure ev population that is devoid of contamination with similar-sized vesicles of different origins. there is also a lack of standards to ensure rigour reproducibility. methods: the current funding opportunity announcement (foa), par - , is promoting research on the isolation and characterization of extracellular vesicles (evs) and their cargo for the discovery of biomarkers to predict cancer and cancer risk. results: the previous cycle of this foa, par - / , successfully funded r and r grants. these awards are focused on proteomics profiling of evs, effect of methodological and biological variability, asymmetric-flow field-flow technology, therapeutic monitoring, lss and sers lab on a chip optical spectroscopic, evs in obesity-driven hepatocellular carcinoma, nanoscale structure and bio-molecular heterogeneity, urinary ev dna, and ev markers in paediatric cancers. progress from these awardees have shown separation of two discernible exosome subpopulations and identified a distinct nanoparticle, the exomere (nature cell biology, ); and have shown that large-evs contain the entire genome of the cell of origin, including cancer-specific genomic alterations (journal of extracellular vesicles, ). protocols that critically evaluate and refine the existing methodologies to improve utilization of evs in clinical use have been shared (nature protocols, ). summary/conclusion: drs. sudhir srivastava and matthew young are the program directors for the par which began accepting applications on january . this and other ev funding opportunities will be discussed. funding: this is a funding opportunity announcement offered by the national cancer institute introduction: early detection of cancer as well as monitoring cancer treatment are important to improve cancer care. diagnostics for cancer are mainly based on tissue biopsies and re-biopsy during treatment is challenging. moreover, current diagnostics are expensive, time-consuming and have low-throughput. therefore, liquid biopsies are expected to bring the next breakthrough in cancer diagnostics. in liquid biopsies tumour-secreted material is isolated from body fluids and subsequent analyses thereof allow for non-invasive diagnostics. one type of tumour-secreted materials are extracellular vesicles (evs), which are schedded from tumour cells. evs are surrounded by a lipid bilayer, whichs composition resembles the plasma membrane of their parental cell. as many tumours are driven by over-expression or upregulation of transmembrane proteins e.g. growth factor receptors, detection of the later on evs holds promise for early tumour detection and treatment monitoring. methods: for the immuno-pcr evs were first affinitycaptured on magnetic beads, allowing immobilization of purified evs as well as evs secreted into cell culture medium or spiked into plasma. afterwards each sample was divided and affibody-dna-conjugates directed against different targets were added. affibodies are small affinity proteins, which often are developed as high affinity binders for tumour imaging, making them suitable probes in the presented assay. after washing, the bead-ev-affibody-dna-complexes were analysed for the immobilized dna-amount via qpcr. results: via the presented immuno-pcr evs secreted from the non-small cell lung cancer cell line h as well as the ovarian cancer cell line skov were analysed. the immuno-pcr method allowed the detection of the tumour-associated membrane receptors epidermal growth factor receptor (egfr), receptor tyrosineprotein kinase erbb /her and insulin-like growth factor receptor (igf r). different levels of membrane receptors depending on the ev source and concentration were detected. summary/conclusion: the presented immuno-pcr showed to be a comparably fast and robust method for detection of tumour-associated membrane receptors on evs derived from cancer cell lines with medium through-put and is currently further developed into a method for liquid biopsy for non-small cell lung cancer patients. introduction: introduction. evs produced by cells can originate from different cellular compartments and evs in complex biofluids may originate from many different cell types. traditional biochemical analysis, which reports on the total composition of all evs in a sample can't adequately resolve this heterogeneity. single vesicle analysis methods can, if they have the necessary specificity, sensitivity and speed. flow cytometry (fc) is capable of rapid and quantitative analysis of individual particles, but conventional fc-based assays lack the specificity and sensitivity to measure individual evs. assays that combine sensitive instruments with ev-selective sample staining can measure individual evs with accuracy and precision. to better understand the nature and origins of ev diversity, we used single vesicle fc (vfc) to quantitatively measure vesicle number, size, and surface cargo expression on individual evs. methods: methods. evs in culture supernatants ( t, a , u , thp- , sh-sy y) were used neat or enriched by standard methods including differential centrifugation or ultrafiltration. evs from platelets (plt) and red blood cells (rbc) were induced by ionophore treatment of washed cells, and measured in diluted supernatant. evs were stained with a membrane-selective dye and fluorescence-labelled antibodies using a commercial vfc assay kit (cellarcus biosciences), measured using a commercial flow cytometer (cytoflexs, beckman coulter), and data analysed using fcs express v (de novo software). vesicle size, fluorescence intensity, and antibody binding were calibrated using appropriate vesicle and beadbased standards and essential controls performed as recommended by the miflowcyt-ev reporting guidelines. results: results. to assess the compositional heterogeneity of evs, we first characterized the expression of tetraspanins (tss; cd , cd , cd , cd , cd , cd , cd ) on evs released from cultured cell line and primary cell cultures. we find quantitative differences in the expression of ts on evs from different cell types that generally reflected the expression on the cell of origin, with most ev types expressing detectable amounts at least one of the common ts molecules (cd , cd or cd ) but generally not all three. in evs from some cell types, ts expression was uniform across the ev population (cd on evs), but evs from other cell types differentially expressed tss, with some evs expressing no detectable ts (rbc evs). intracellular cargo labelled genetically using fluorescent proteins (egfp or mneongreen) or fluorogenic enzyme substrates (cfse) were measured in individual evs and revealed distinctive associations between ev surface and internal cargo. summary/conclusion: conclusions. high resolution measurement of cargo on/in individual evs can help interpret ev heterogeneity in terms of cell of origin, signals carried, and effects on target cells. integrated omics reveal conserved and divergent modulation of cardiovascular disease by tissue-entrapped extracellular vesicles introduction: fewer than % of patients develop both vascular and valvular calcification, implying differential pathogenesis. while circulating extracellular vesicles (evs) act as biomarkers of cardiovascular diseases, tissue-entrapped evs are implicated in early mineralization but their contents and function are unstudied. we developed an innovative method to isolate and study evs from fibrocalcific tissue and investigated entrapped ev cargoes in human cardiovascular diseases. methods: human carotid artery endarterectomies and stenotic aortic valves were obtained from donors under irb-approved informed consent. tissues underwent enzymatic digestion, ultracentrifugation, and a -fraction optiprep density gradient. global proteomics was performed on intact tissue, each optiprep fraction, and ev-enriched pooled fractions; the latter also underwent mirna-seq. fractionated samples were also studied by cd immunogold electron microscopy (tem) and nanoparticle tracking analysis (nta). high confidence mir targets were predicted by targetscan, pathway analyses utilized the biocarta/kegg/reactome databases, and protein-protein interaction networks were built in string. results: vesicle-associated pathways were increased . x (p < . ; / vesicle-related top go terms) in proteins common to intact arteries and valves (n = , ). proteomics found ev markers to be highly enriched in the four least-dense optiprep fractions of arteries and valves, while extracellular matrix and mitochondria were predominant in denser fractions, as confirmed by tem/nta. proteomics and mirna-seq of tissue evs quantified , proteins and mir cargoes linked to , target genes. pathway networks of proteins and mir targets common to artery and valve tissue evs revealed a shared regulation of rho gtpase and mapk intracellular signalling cascades. proteins and mirs were significantly altered between artery and valve evs (q < . ); multi-omics integration found that evs differentially modulated cellular contraction and p mediated transcriptional regulation in vascular and valvular tissue. summary/conclusion: our findings delineate a novel strategy for studying tissue-entrapped ev protein and mir cargoes and identify critical roles that tissue-resident evs play in mediating cardiovascular disease. funding: this study was supported by a research grant from kowa company (ma) and nih grants r hl , r hl and r hl (ea). mir- a regulates exogenous cd expression on proliferation, invasion, migration and angiogenesis of gastric cancer zhengzhou university, zhengzhou, china (people's republic) introduction: to investigate the possible mechanism of mir- a regulating the expression of exosome cd on proliferation, invasion, migration and angiogenesis of gastric cancer, and to study the application value of cd in the early diagnosis and prognosis of gastric cancer. methods: the gastric cancer cell line mgc- was used as the research object. the exosomes were extracted from the culture supernatant of mgc- by exosome extraction kit. the extracted exosomes were identified by transmission electron microscopy and western blotting. the expression of cd in exosomes was detected by elisa. the expression of cd in exosomes and cd in whole blood and serum were detected by western blot. they were randomly divided into blank group (mock) and mir- a lentivirus experimental group (mir- a group). the lentivirus control group (mir- a/con) was transfected into cells. qrt-pcr was used to verify the status of mir- a after transfection; western-blot was used to detect the expression of cd and downstream erk / , akt and m tor proteins; mtt assay, cell colony formation assay, transwell migration assay for cell proliferation, invasion, and migration. a nude mouse xenograft model was constructed to observe the growth of transplanted tumours,microvessel density (mvd) was detected by immunofluorescence, and distant metastasis was recorded. results: the expression of cd in exosomes was detected by elisa and western blot. the expressions of cd , akt, erk / and m tor in mir- a group were significantly lower than those in mir- a/con and mock groups. cd protein is positively correlated with downstream protein levels.the growth rate and cell invasion ability of mir- a group were significantly lower than those of mir- a/con group and mock group. the weight of the nude mice in the mock group and the mir- a/con group decreased, while the weight loss in the mir- a group was not significant. the tumours in the mir- a/con group and the mock group showed invasive growth accompanied by abundant microvessels, while the mir- a group had smaller tumour volume and uniform cell distribution. only a small amount of microangiogenesis was observed, and no obvious necrotic area was observed. summary/conclusion: mir- a affects the proliferation, invasion, migration and angiogenesis of gastric cancer mediated by akt/erk/m tor signalling pathway by regulating the expression of exosome cd . streamlined detection and quantification of plasma extracellular vesicles and their protein cargo by high-performance nanoscale flow cytometry and label-free mass spectrometry introduction: nanoscale flow cytometry (fc) and mass spectrometry (ms) are useful for profiling ev surface proteins and performing bulk ev proteomics, respectively. this study sought to develop pre-analytical and analytical pipelines for ev protein profiling that are applicable to clinical studies. methods: to optimize plasma ev detection and quantification by fc, modifications of instrument settings and serial dilutions of platelet-free plasma (pfp) and antibodies were tested for improved separation of signal from noise and reduction of event coincidence and swarming. the high-performance flow cytometry (hpfc) platform was used to assess the effect of time ( , , , , , , or hrs) between blood draw (into acd, nacit, edta or heparin) and blood processing, on ex-vivo release of evs from blood cells. label-free ms was used to examine the intensity and breadth of identified proteins in plasma evs purified using several density and size separation methods, either manually or automated, along with various buffer conditions. results: ev event aborts were minimized at a pfp dilution, prior to staining, of : and by using a narrow cytometer window extension. target ev signals were distinct from noise and were triton x- labile. the most significant changes in plasma evs were associated with platelet-derived fractions, use of heparin and > -hour delay before blood processing. yet, platelet ev numbers did not significantly change for up to hrs in citrated and edta plasma. higher overall coverage of known ev proteins and a fivefold increase in number of uniquely identified proteins were observed in ms profiling of evs prepared by a combination of ultracentrifugation (uc) and manual size-exclusion chromatography (sec) compared to preparation by fplc on capto core /superose resins. uc/sec was better than direct sec at reducing contamination by excipient plasma proteins. column buffers with trehalose increased ev protein recovery while adding protease inhibitors had minimal effect. summary/conclusion: with our optimized hpfc protocol, we established that blood ev numbers remain stable for up to hrs in acd or edta and that uc+sec with trehalose-containing buffer result in high canonical ev protein recovery. we are applying these workflows to investigate cancer-associated changes in plasma ev protein cargo. the value of exosomes as a potential biomarker for devil facial tumour disease. university of tasmania, hobart, australia introduction: the tasmanian devil (sarcophilus harrisii), the largest living carnivorous marsupial is endangered because of two transmissible cancers: devil facial tumour disease (dftd) one and two. current efforts to manage dftd are hindered by the lack of a preclinical diagnostic test for dftd. detecting dftd infection is only possible once tumours are noticed, too late to stop dftd progression. a preclinal test could tell us about unknown components of dftd pathogenesis, such as latent period and host-tumour dynamics. exosomes are extracellular vesicles released by most types of cells under both physiological and pathological conditions. exosomes have utility as diagnosis and prognosis biomarkers in a range of diseases, including cancers. the aim of this study is to investigate exosomes-based approaches towards a preclinical and progression biomarker for dftd and in tasmanian devils. methods: exosomes were isolated from three different dftd- , dftd- and devil fibroblast cell lines by sizeexclusion chromatography. likewise, exosomes were isolated from plasma of healthy and diseased devils. to determine the size and morphology of exosomes, samples were imaged with transmission electron microscopy. exosomes isolated from cell lines and devil plasma were analysed with mass spectrometry to characterise proteins and determine their differential expression between the cell origins, and healthy and diseased animals. results: this study identified the presence of myelin proteins in exosomes from dftd cells relative to fibroblasts, which are diagnostic of dftd. additionally, we found that exosomes derived from dftd- abundantly express the inhibitory checkpoint molecule cd relative to exosomes from dftd- cells and devil fibroblasts, indicating a potential candidate for a differential diagnosis between tumours. moreover, exosomes from dftd cells present a greater amount of proteins related with metastasis in comparison with fibroblast exosomes, such as integrins. finally, we report the protein expression profile of exosomes from healthy and diseased devils, showing clear differences between them and the presence of immunosuppressive and metastasis proteins in animals in late stages of the disease. summary/conclusion: dftd-exosomes may provide a non-invasive diagnosis tool to detect early stages of dftd in tasmanian devils to facilitate the prevention of the disease. furthermore, dftd-exosomes may have utility as a prognosis biomarker, determining late stages of the disease using a simple a blood test, which would facilitate monitoring of wild populations. this project will provide long-term benefits for the future of the devils and encourage exosome-based solutions for other future wildlife disease outbreaks. introduction: despite the increased understanding of evs, from involvement in disease pathophysiology to therapeutic delivery, improved molecular tools to track biodistribution are largely lacking. current approaches used for ev labelling lacks sensitivity and specificity. here, we have explored bioluminescent labelling of evs to achieve a highly sensitive system for absolute in vivo quantification and tracking of exogenous evs at low cost and in a high throughput manner. methods: ev-producing cells were genetically engineered to express various tetraspanin-luciferase fusion proteins. evs purified by uf-sec from these cells were characterized by nta, multiplex bead-based array, tem and wb, followed by luciferase assay to determine the labelling efficiency. for in vitro applications cell lysate from treated cells or the conditioned medium were subjected to luciferase assay. for in vivo applications two different methodologies were applied to determine biodistribution; either by non-invasive real time in vivo imaging using ivis or by luciferase assay on harvested tissues for absolute quantification of injected evs. results: we initially performed a systematic comparison of five different luciferases for endogenous labelling of evs and identified nanoluc and thermoluc as lead candidates. we applied this technology to monitor in vitro cellular uptake and observed cell type differences in cellular uptake of engineered evs. in addition, we also observed an effect of different culturing conditions on exocytosis kinetics. for in vivo application, we applied the nanoluc labelling strategy to determine the pharmacokinetics and effect of different routes of injection on ev distribution. our results indicated a rapid uptake profile of administered evs in different tissues with liver, spleen, and lungs being the primary recipients. we also observed similar results upon tracking in vivo biodistribution in real time immediately after administration. finally, we show how different subpopulations of evs differ in their in vivo biodistribution. summary/conclusion: overall, nanoluc and thermoluc labelling of evs holds great potential for various in vivo and in vitro applications. in addition, it can enable the simultaneous detection of different subpopulations of evs in vivo, which may aid in our understanding of different sub-populations and their behaviour in vivo. apart from monitoring therapeutic evs, with one simple modification this platform offers great potential for tracking tumour derived evs both in vivo and in vitro and thus could aid in the development of anti-tumour therapies. biofunctional peptide-modified extracellular vesicles for cell targeting, macropinocytosis induction, and effective intracellular delivery ikuhiko nakase department of biological science, graduate school of science, osaka prefecture university, sakai-shi, japan introduction: [introduction] in our research group, developing therapeutic techniques based on extracellular vesicles (exosomes, evs) by effective usage of peptide chemistry to deliver therapeutic/diagnostic molecules into targeted cells has been focused. in this presentation, modification techniques using biofunctional peptides such as arginine-rich cell-penetrating peptides [ ] , artificial coiled-coil peptides with receptor targeting [ ] , and cell-penetrating sc peptides [ ] derived from cationic antimicrobial protein, cap for cancer targeting with macropinocytosis induction, on the ev membranes will be introduced. i will also show effects of lyophilization of the peptidemodified evs on their biological activity [ ] . methods: [methods] cd (ev marker)-gfpfusion protein expressed evs were used for cellular evs uptake assessments. all biofunctional peptides were synthesized by fmoc solid-phase method. results: [results] macropinocytosis with actin reorganization has been shown to be crucial for cellular ev uptake [ ] . we developed the methods for modification of arginine-rich cpps or sc peptides on ev membranes using chemical linker techniques, and for example, arginine-rich cpps modification can induce proteoglycan-clustering (e.g. syndecan- ) and macropinocytosis signal transduction [ ] . the artificial leucine zipper peptide-modified evs recognize the peptide-tagged epidermal growth factor receptor (egfr) on targeted cells, leading to macropinocytotic cellular ev uptake [ ] . in addition, lyophilization is a useful technique for long term storage, however, we found that lyophilization negatively affected biological functions of encapsulated proteins in the evs after their cellular uptake [ ] . summary/conclusion: [conclusion] these techniques and findings will contribute to development for the ev-based intracellular delivery systems. reference: [ ] sci. rep. , ( ), [ ] chem. commun. , ( ), [ ] chrmmedchem. , ( ) [ ] anticancer res. , ( ), [ ] sci. rep. , ( ) os . multi-compartmented microvesicles: novel extracellular secretory organelles that release exosomes and extracellular vesicles introduction: extracellular vesicles (ev) bud from the plasma membrane (pm) as microvesicles (mv) or arise from the fusion of multivesicular bodies (mvb) with the pm to release intralumenal vesicles (ilv) as exosomes. the variety of bioactive molecules carried by ev imparts diverse functionality to ev in intercellular signalling. the biogenesis and extracellular release of these specialized messenger organelles is not well understood. to investigate, we studied endothelial cells that line the inside of blood vessels, known to release ev that support angiogenesis. methods: cultured human umbilical vein endothelial cells (huvec) were examined by thin-section electron microscopy (em), serial sectioning and immunogold labelling to study the structure and composition ev release sites. to obtain optimal views of cellular ultrastructure, cells were preserved by fast-freezing and a freeze-substitution. results: a potential release site was identified in em thin sections as a discrete domain, up to several microns long, on the otherwise smooth huvec pm, where numerous bulbous membrane protrusions with thin necks were clustered. the cytoplasm in these protrusions was enriched with mvb and other vesicles and appeared to be on the verge of pinching off to release multi-compartmented mv (mcmv). consistent with this notion, in the neighbouring extracellular space, a plethora of mcmv of - nm with ultrastructural features matching the bulbous protrusions were observed, supporting the concept that mcmv bud from the release site. serial sections confirmed that these extracellular mcmv were independent of cells and not linked by nanotubes or other processes. remarkably, fusion of mvb with the mcmv membrane was directly observed, presumably caught in the act of releasing ilv (exosomes) from the mcmv. immunogold labelling for ev markers is being used to identify proteins enriched at release sites and on released mcmv. summary/conclusion: in summary, ) mcmv bud from localized sites on the endothelial pm, ) mcmv contain mvb, and ) fusion of mvb to mcmv to release exosomes occurs extracellularly. mcmv can now be evaluated as a potential source of exosome and ev release that occurs after budding from the cell of origin, adding new layers of regulation to when, where and how ev are assembled and released. funding: this work was supported by the division of intramural research of the nih. one size does not fit all: overcoming barriers to successful discovery and scaled manufacturing of therapeutic extracellular vesicles jieun lee a , wei guo b , hal sternberg c , mike west d and dana larocca d a stem cell team, seoul, republic of korea; b university of pennsylvania, philadelphia, usa; c agex therapeutics inc, alameda, usa; d agex therapeutics inc., alameda, usa introduction: extracellular vesicles have tremendous intrinsic therapeutic potential. however, the limited availability of production cell lines presents a barrier to scaled ev production and novel ev discovery. indeed, ev sources have been largely confined to a handful of cell types with the vast majority consisting of msc evs. to overcome this limitation, we developed a diverse library of hundreds of clonally pure and scalable progenitor cell lines that provides an alternative resource for ev drug discovery and production. methods: we harnessed the capacity of human pluripotent stem cells (hpsc) to differentiate into virtually any cell type by subjecting hpsc to a wide variety of media and culture conditions to maximize the diversity of partially differentiated cells. the resulting heterogeneous "candidate cultures" were plated at clonal density and further selected for self renewing and scalable clones. transcriptomic analysis indicated > distinct progenitor lines. cell fate potentials were mapped by screening for cell type specific marker expression in various differentiation conditions. evs were produced using cgmp methods (tff and sec) and characterized by nta, trps, surface marker analysis, rna and protein content. bioactivity assays included proliferation, migration, vascular tube network formation, senolysis, and oxidative stress. results: the progenitor library contained > distinct lines with diverse lineage fates including various types of bone, cartilage, muscle,and fat cells, as well as all blood vessel cell types. the lines displayed much longer replicative lifespans ( - pd) than primary cell lines like msc. clonal purity minimized phenotypic drift resulting in maintenance of cell identity, genome integrity, differentiation capacity and bioactive ev production over extended culture. evs were highly diverse in their rna and protein cargo and bioactivity displaying various degrees of migratory, proliferative, angiogenic and senolytic activity. library screening identified evs with higher angiogenic potency than primary adult stem cell evs. summary/conclusion: we demonstrated scalable and stable production of bioactive evs from a large progenitor cell library. library screening resulted in discovery of novel angiogenic and senolytic evs having diverse rna and protein cargo. we are currently creating a corresponding library of progenitor cell evs to accelerate discovery of novel evs and their production cell lines. funding: the initial establishment of the cell library was funded in part by grants from the california institute of regenerative medicine and national institutes of health. introduction: besides extreme potential in biomedical applications, extracellular vesicles (evs) are also promising candidates to expand biophysical understanding of membrane active biomolecules. their complex bilayer composition allows the better understanding of adsorbed proteins and protein coronas as well, which sets of macromolecules will likely be key for advanced ev targeted delivery. considering cargo, membrane active peptides are interesting as these can be both drugs to be delivered, but can also facilitate cargo insertion through lipid bilayers. however, at present very little is understood regarding interactions between the peptides and the ev lipid bilayer, and between peptides and membrane associated proteins on evs. methods: we have recently demonstrated, that ev membrane adsorbed proteins and their interactions can be studied by techniques such as polarized light spectroscopy, microfluidic resistive pulse sensing measurements and freeze-fraction transmission electron microscopy [ ] . furthermore, initially we studied several peptides with known antimicrobial properties and found that these strongly interact with the ev surface proteins, resulting in efficient removal of some from the lipid bilayer [ ] . results: here we present investigation of further evpeptide interactions also focusing on anticancer peptides, which may be promising drug candidates for targeted delivery. these studies allowed to gain insight to novel functions of several peptides, such as melittin, magainin, buforin, lasioglossin, temporin, but also provide a more detailed understanding on how ev protein coronas, or ev bilayers are affected, to such extent that they cannot exert their potential function as delivery systems. summary/conclusion: the above interactions are expected to be interesting both for applicability, i.e. for selecting suitable compounds for ev processing, and also for curiosity-driven understanding of peptide functions, and ev-biomolecule interactions. based on these we promote that peptide -ev interactions will receive increased focus in ev-engineering. introduction: our late-breaking finding is the identification of a non-coding rna (ncrna) in extracellular vesicles (evs) from neuronal cells that is a natural antisense transcript for the dbh gene and associated with epigenetic changes and gene silencing. dna methylation in neurons is involved in memory and neurological disorders (science ( )). earlier work found that during chronic brain infection with toxoplasma gondii induced a decrease in norepinephrine levels and expression of the host dbh gene; and the decrease is correlated with behaviours linked to noradrenergic signalling (infect immun. ( ); infect immun. ( )). dbh catalyzes the production of norepinephrine from dopamine in noradrenergic neurons. we found that evs from infected cultures suppress transcription of the dbh gene and hypermethylation of the gene in noradrenergic cells in vitro. in this study, we identify a ncrna in the evs from infected neuronal cells. methods: neuronal cells were induced by infection with toxoplasma gondii and evs purified on sucrose gradients. evs were characterised by electron microscopy and used to treat rat and human neuronal cells and expression levels of dbh mrna and nascent dbh gene transcription were measured. induced evs were injected into the locus coeruleus of rats and dbh gene expression was monitored. rna purified from evs was screened for natural antisense transcripts (nats) by strand-specific rt-pcr. results: we found that evs purified from infected neuronal cultures induced transcriptional gene silencing (tgs) and dna methylation of dbh in recipient neuronal cells. the induced evs down-regulated dbh gene expression > -fold and induced dna hypermethylation of the dbh gene. this could be induced in the brains of recipient rats by intracerebral injection of evs. using a panel of strand-specific primers, antisense transcripts for the dbh gene were identified in infected cells. this permitted us to examine the rna in purified evs and identify a lncrna in evs selective for evs from infected cultures. summary/conclusion: this is the first study to find a specific neurotransmitter antisense lncrna in evs associated with transcriptional gene silencing and epigenetic changes in the gene. this represents a different type of neuron-to-neuron signalling than the classic chemical and electrical neurotransmission. the findings will enhance our understanding of neurological disorders (ie. schizophrenia, epilepsy, drug addiction) and how memory works. human cd + t regulatory-derived extracellular vesicles and associated micrornas: role in cell-to-cell communication and involvement in the loss of immune tolerance during multiple sclerosis introduction: an impairment of immune tolerance is a determining factor in multiple sclerosis (ms) and dysregulation of cd + t regulatory (treg) cell function is believed to be a major pathogenic factor. micrornas (mirnas) released by treg cells in association with extracellular vesicles (evs) have been shown to participate in the block of pathological immune responses by inhibiting the growth and cytokine production of cd + t conventional (tconv) cells, but the molecular mechanism is still poorly characterized. aim of the present work was to evaluate whether treg cell-derived ev-associated mirna signature is dysregulated in ms and whether this defect may play a role in the development of autoimmunity. methods: human treg cells isolated from blood of naïve to treatment relapsing-remitting ms patients and healthy controls were in vitro stimulated and released evs were isolated by size exclusion chromatography and characterized by nanoparticle tracking analysis, electron microscopy and flow cytometry. evassociated mirnas were quantified by traditional rt-qpcr and droplet digital pcr for absolute quantification. the actual ev-mediated passage of rna molecules from cell to cell was followed through rnaspecific fluorescent staining and treg-derived ev effect on tconv cell transcriptome was evaluated by rnaseq. results: in healthy conditions, the treatment of tconv cells with treg-derived evs was shown to cause the specific repression of genes involved in the proteasome-dependent proteolytic process, known to be crucial for t cell activation. in ms, treg-derived evs may have lost this capability as a direct consequence of a significantly decreased expression of mir- - p, able to target key factors of the proteasome system. summary/conclusion: our results unveil a novel molecular mechanism for treg-mediated maintenance of self-tolerance based on ev-associated mir- - p and its potential alteration in human autoimmunity. funding: fondazione italiana sclerosi multipla, fism, # /r/ and # /r/ revealing the proteome of brain derived extracellular vesicles isolated from human amyotrophic lateral sclerosis post-mortem tissues. introduction: amyotrophic lateral sclerosis (als) is a neurodegenerative disease characterised by the deposition of misfolded proteins in the motor cortex and motor neurons. although a multitude of als-associated proteins have been identified, few have been associated with extracellular vesicle (ev) trafficking, a form of inter-cellular communication. additionally, the role of evs in als is undetermined, specifically in relation to pathogenic stress granule formation, a response to cellular stress involving aggregation of non-coding rnas and their rna binding proteins. therefore, this study aimed to determine the proteome of brain derived small extracellular vesicles (bdevs) isolated from als subjects and identify novel alsassociated deregulated proteins and their potential contributions to pathogenic pathways in als. methods: bdevs were isolated from human post-mortem als (n = ) and control (n = ) motor cortex brain tissues through an ultracentrifugation protocol (vella et al., ) . following thorough characterisation, bdevs that successfully met the minimum criteria required by the international society for extracellular vesicles were classified as evs. the bdevs subsequently underwent mass spectrometry analysis on the thermo scientific q-exactive hf with ultimate rslcnano. proteins identified to be statistically significant differentially expressed then underwent validation by western blotting. results: a panel of statistically significant differentially packaged proteins were identified in the als bdevs. this included several up-regulated rna binding proteins and a down-regulated cell adhesion molecule; dhx , stau and vcam , respectively. pathway analysis revealed that the bdevs were enriched in proteins associated with stress granule dynamics, exosomal and lysosomal pathways. summary/conclusion: the identification of the rna binding proteins in the als bdevs suggests there may be a relationship between als-associated stress granules and als bdev packaging. the packaging of stress granule associated rna binding proteins into als bdevs may be an attempt by the cells to compensate for lysosomal dysfunction caused by stress granule accumulation, a feature of als. thus, these results highlight a potentially novel role for evs in the pathogenesis of als for long-term cultivation . the whole cultivation process of tissue preparation, cultivation, and cryopreservation has been established using strict serum-free conditions under a good manufacturing practice. long-term-cultivated hmnpcs retained stemness and hmnpcs have excellent differentiation efficiency into dopaminergic neurons. hmnpcs reversed impaired motor function in a rodent model of parkinson's disease (pd). based on the promising results in animal experiments, the clinical trial is under way (nct ). multiple-system atrophy (msa) is one of fatal neurodegenerative diseases with a combination of progressive autonomic nervous system disorders, parkinson's syndrome, and cerebellar pyramid syndrome. there are three types of msa such as msa-a, msa-c, and msa-p. in case of a msa-p type, it is difficult to diagnose due to the similarity of symptoms with parkinson's disease (pd). methods: in vitro and in vivo animal msa model were established and rotational behavioural was performed. npc cells were isolated and cultured based on moon et al. mirna sequencing (bgi) was performed and several bioinformatics analyses were done. results: based on the finding that hmnpcs exhibited therapeutic effects on pd, we hypothesize that hmnpcs will have a therapeutic effect on msa-p, where sympotoms are largely common with pd. as expected, transplanted hmnpcs survived, integrated, and differentiated in to dopamine neurons in the host brain, consequently leading to the functional recovery in the msa-p model. to further investigate the therapeutic key factors of hmnpcs in msa-p, mirna sequencing of the extracellular vesicles (evs) secreted from hmnpcs was performed. we found that mir- a highly expressed in the npc-derived evs is one of key regulators of inflammatory response via nfkb pathway. we further experimentally demonstrated that mir- a had anti-inflammatory effect on cells of msa-p condition such that the level of cx cl expression and its receptor, cx cr were both decreased in the msa-p modelled cells and in severe inflammatory environment in msa brain. summary/conclusion: our study first showed that mir- a in hmnpcs-evs is one of key therapeutic factors for the recovery of brain damage through immuno-modulation in msa-p. introduction: oxidative insults are known to be involved in the pathophysiology of alzheimer's disease (ad). we have previously demonstrated that some blood-based redox-signature were associated to the cognitive scores in mild cognitive impairment patients and in ad (perrotte et al., ) . the aim of this study was ( ) to evidence the presence of some oxidative markers in circulating extracellular vesicles (evs), and ( ) to compare to their plasma levels. methods: plasma samples from healthy, mci and ad patients were from the memory clinic of sherbrooke (québec, canada). ad patients were stratified in three groups (moderate, mild and severe) according to the mmse and moca scores. total plasma extracellular vesicles (pevs) were isolated from plasma with the total exosome isolation reagent (invitrogen™ by life technologies inc.). pevs were then characterized by electronic microscopy, nta, dls and western blot. antioxidants apolipoprotein j, d (apo j, apod), the glyoxalase- and protein carbonyls were determined by western blot. results: in pevs, we found that apo d levels were higher in mci patients but not in ad patients. protein carbonyls levels were higher later, in pevs from moderate and severe ad while apo j levels were not different in pevs from the five groups of patients. in plasma, the pattern of apo j and apo d was different. the levels of apo d was not different in the five groups of patients while apo j levels were elevated in mci and in all ad groups. protein carbonyls were higher earlier from mild ad group, earlier than in pevs. the levels of the detoxifying enzyme glyoxalase- were higher in pevs than in plasma and were significantly decreased in early ad as compared to control subjects and mci summary/conclusion: these results demonstrate a differential regulation of redox homoeostasis in plasma and in pevs from ad patients. funding: acknowledgements: this work was supported by the chaire louise & andré on alzheimer's disease, foundation armand-frappier (cr) and cihr grant (tf). carlos j. nogueras-ortiz a , pavan bhargava b , sol kim b , francheska delgado-peraza a , peter calabresi b and dimitrios kapogiannis a a laboratory of clinical investigation, national institutes of ageing, baltimore, usa; b department of neurology, johns hopkins university school of medicine, baltimore, usa introduction: multiple sclerosis (ms) is a neurological disorder characterized by white matter demyelination and extensive synaptic pathology. recent studies have shown synaptic loss in the grey matter of ms brains in the absence of demyelinating lesions which could account for disease progression independent of demyelinating episodes. opsonization of synapses with complement components is a mechanism by which phagocytic cells normally prune synapses, but, when occurring in excess, it may underlie pathologic synapse loss. we sought to identify blood-borne biomarkers of hypothesized complement-mediated synaptic loss in ms using circulating neuronal-enriched and astrocytic-enriched extracellular vesicles (nevs and aevs). methods: nevs and aevs were immunocaptured in parallel from the plasma of ms patients ( with relapsing remitting, with progressive ms) and healthy controls, targeting the neuronal-specific marker l cam and the astrocyte-specific marker glast, respectively. we measured the protein levels of preand post-synaptic proteins synaptopodin and synaptophysin in nevs using elisas and multiple complement cascade components (c q, c , c b/ic b, c , c , c a, c , factor b, factor h) in aevs using a luminex array. results: synaptopodin and synaptophysin protein levels in nevs of ms patients compared to controls were markedly reduced ( . -fold; p < . for both), whereas multiple complement components in ms aevs were markedly increased (c q: . -fold change; c : . -fold change; c b/ic b: twofold change; c : . -fold change; c a: . -fold change; factor: . -fold change; p < . ); differences were not observed in total circulating evs or neat plasma. strikingly, we found the nev-associated synaptopodin/synaptophysin and the aev-associated complement levels to be negatively correlated in people with ms (synaptopodin vs: c q, r = − . and p < . ; c , r = − . and p < . ; factor h, r = − . and p < . /synaptophysin vs: c q, r = − . and p < . ; c , r = − . and p < . ; factor h, r = − . and p < . ), but not in controls. summary/conclusion: circulating evs provide markers of synaptic loss and complement activation in ms and suggest a link between astrocytic complement production and synaptic decline. funding: this research was supported in part by the intramural research program of the national institute on ageing, national institutes of health. methylglyoxal and glyoxal affect the protein cargoes in neuronal-derived extracellular vesicles introduction: advanced glycation end-products (ages) and their receptor rages are known to be involved in the pathogenesis of alzheimer's disease (ad). methylglyoxal (mg) or glyoxal (go) are the precursors of ages and particularly n-( -carboxymethyl)-l-lysine (cml), the most abundant ages. mg induced tau hyperphosphorylation and causes hippocampal damage and memory impairment in mice. the aim of our study was to analyse the effects of mg and go on the neuroprotective, neurotrophic factors, inflammatory and neurodegenerative markers in the human cell line sk-n-sh and their release into the neuronal derived-evs. methods: briefly, sk-n-sh cells were incubated in fbs free media with mg and go ( . mm) for hours. neuronal derived-evs (nevs) from culture media were isolated as previously described (haddad et al. ). nevs were characterized by electronic microscopy, nta and by western blot. cellular and nevs concentrations of bdnf, prgn, nse, app, mmp , angptl- , lcn , ptx , s b, rage, dj- and alpha synuclein were determined by a luminex assay from r&d systems, inc. aβ - , aβ - , ptau t and total tau levels were measured also with luminex assay from emd millipore corp. results: we found that both ages precursors, at non toxic concentration, reduced the neuronal levels of nse with no effect on bdnf, ptrx- , lcn- , dj- , on neurodegenerative markers and on cml. go decreased the levels of prgn, app, angpl- while the expressions of mmp- and angpl- were, respectively lower and higher in the presence of mg. mg and go greatly reduced the release of lcn- by neuronal cells in nevs. bdnf and prgn in nevs were reduced in the presence of go. both mg and go did not modify the release of nse, app, mmp , agntl- , ptx- , dj- , aβ, ptau and cml in nevs. summary/conclusion: our data demonstrated that mg and go differently affect the content of some protein cargoes in nevs and suggest that targeting mg and go may be a promising therapeutic strategy to prevent neurodegeneration. introduction: peripherally circulating brain-derived extracellular vesicles (evs) and their encapsulated rnas may serve as biomarkers for hiv-associated neurocognitive disorders (hand). however, rates of cigarette smoking are significantly higher in hiv+ individuals than the general population, and smoking can modulate the expression of these markers. to better understand how cigarette smoke might modulate rna expression and ev release, we examined several cnsderived cell lines, representing astrocytes (u mg), microglia (sv ), and oligodendrocytes (hog). methods: cigarette smoke extract (cse) was prepared by bubbling through culture medium using a standardized and published method. all cell types were exposed to either % or % cse for hours. cell viability was assessed by musetm cell analyser, and evs were isolated from culture conditioned media (ccm) by size exclusion chromatography. the void (fractions - ), ev ( - ), and protein ( - ) enriched fractions were pooled and concentrated. evs were characterized by transmission electron microscopy (tem), microfluidic resistive pulse sensing, and western blotting. total rna was isolated from cells and circular rna (circrna) expression was assessed with a circrna microarray. results: in response to cse exposure, cell viability was only slightly reduced for all cell types. tem images validate the presence of vesicles in the ev fractions, and their absence in the void and protein fractions. spectradyne particle counts indicated cse exposure substantially increased the ccm particle count in the ev fraction when compared with control. the presence of expected ev markers (cd , cd , and tsg ) in the ev fractions, and their absence in the void and protein fractions was observed via western blot. intracellular circrna expression was significantly altered in all three cell lines. summary/conclusion: cns cells display physiologic responses to cse that include vesiculation pathways and significant alterations in circrna expression. we are now studying the effects of cse exposure on circrna expression in released evs. funding: this work is supported by da , da , and ai . a method for exosomal rna extraction from paired human brain and blood specimens emily n. moya a , lillian wilkins a , esther cheng a , lisa linares b , brian kopell b , navneet dogra c , bojan losic a and alexander charney a a icahn school of medicine at mount sinai, new york, usa; b mount sinai hospital, new york, usa; c department of genetics and genomic sciences, department of pathology, icahn school of medicine, mount sinai, new york, usa introduction: diagnosis and treatment of neuropsychiatric disorders has made little progress in the last half-century likely in large part due to the absence of a scalable technique to profile the complex biological activity of the brain in a living person. exosomes are nanovesicles - nm in size that mediate intercellular communication and contain proteins, lipids, and nucleic acids. it has been shown that brain derived exosomes can be found in peripheral blood, but determining whether peripheral exosomes truly reflect ongoing brain processes has to date not been possible due to the absence of paired living brain and blood specimens. here, we present a novel method for paired sampling of the dorsolateral prefrontal cortex (dlpfc) and peripheral blood from living human subjects for exosomal rna profiling. methods: informed consent, approved by the irb at the icahn school of medicine at mount sinai, was obtained for patients undergoing deep brain stimulation (dbs). paired brain and blood specimens were collected from patients at two deep brain stimulation (dbs) electrode implantation procedures: left hemisphere followed by right hemisphere (total of samples). we developed protocols to profile rna from exosomes of brain tissue extracellular matrix (ecm) and peripheral blood. exosomes were isolated via our in-house protocol using ultracentrifugation. rna was then extracted from the exosomes using the qiagen mirneasy mini kit protocol. quality control (qc) was performed to determine whether rna obtained was sufficient for next-generation sequencing. results: we demonstrate the safety of a novel procedure to sample the brain in living human subjects. bioanalyzer traces and qc data show a mean total rna of . ng (range . - . ng) and no samples fell below the threshold required for library preparation and sequencing ( pg) determined by inhouse optimization on the smart-seq v ultra low input kit. summary/conclusion: to our knowledge, we have performed the first study to sample pairs of dlpfc and blood from living human subjects for exosomal rna for subsequent next-generation sequencing. ongoing analyses by our group promise to establish peripheral exosomal rna transcripts reflective of brain activity. this non-invasive approach to probing neurobiology in the living human brain may facilitate the development of exosome-based diagnostics for neuropsychiatric disorders. introduction: the relationship between obesity and dementia is complex. while obesity in middle age triples the risk of dementia years later, many patients with alzheimer's disease (ad) are cachectic, and a decline in adiposity portends progression of dementia. this suggests adipose-derived factors are important to nervous system homoeostasis. we previously showed that adipocyte-derived small extracellular vesicles (ad-sevs) induce pathologies critical to developing obesity-related diseases and may provide a mechanistic link between adiposity and dementia. we hypothesized that altered expression of ad-sev micrornas involved in neurodegenerative pathways is associated with more severe cognitive impairment methods: we studied serum and cerebrospinal fluid (csf) from participants with ad and non-ad controls. ad-sevs were isolated from samples by precipitation and immunoselection. ad-sev microrna expression was profiled in both biofluids and compared. results: serum and csf microrna expression correlated strongly (r = . ). in serum, micrornas were differentially expressed by a fold change ≥| . | in the ad and control groups (p ≤ . ) and micrornas were differentially expressed in csf. using ingenuity pathways analysis, we identified mrnas expressed in nervous system tissue that are targeted by the differentially expressed micrornas. the mrnas map to diseases and functions; neuronal cell death, neurodegeneration, and neuronal growth and developmental pathways are highly represented. of the differentially expressed micrornas in serum, were moderately correlated with participants' score on the mini-mental state exam, a test of cognitive function (rs = | . - . |). as validation, rencell cx cortical derived neuronal stem cells had decreased doubling time when exposed to ad-sevs from obese adipose tissue in vitro. summary/conclusion: these findings support our hypothesis that altered expression of circulating ad-sev micrornas are involved in neurodegenerative pathways associated with cognitive impairment. these findings support using serum ad-sevs as a surrogate for csf ad-sevs. functional validation is underway to define the connection between ad-sevs and ad. understanding the link between obesity and ad is crucial as the population ages and the global obesity epidemic grows. funding: supported by uw adrc (nih:p ag ) expression of extracellular vesicles after acute traumatic brain injury: an exploratory flow-cytometry study introduction: coagulation derangements related to disseminated intravascular coagulation (dic) are common after tbi and contribute to secondary neural injury. extracellular vesicles (evs) are released from all cell types, including platelets, endothelium, and lymphocytes, which are responsible for dic. we hypothesized that specialized flow cytometry techniques could identify a unique ev signature of dic in acute tbi. methods: using a modified flow cytometry instrument for detection of small particles, fluorescence panels were created to assess for evs from endothelial cells (cd , cd ), platelets (cd , cd p, cd a, cd b), and erythrocytes (cd ) as well as brain biomarkers (s b, uchl- , gfap, tau and nse) and t-lymphocytes (cd , cd , cd , cd ). samples were prepared in trucount tubes to determine volume and treated with triton to confirm presence of evs. results: / study patients and / controls were male. % of study patients presented with a glasgow coma scale of . in the hypercoagulability panel, of the subsets with statistically significant differential expression, involved s b+ and were elevated in patients. platelet-derived cd a evs and uch-l evs were significantly elevated in controls in ev subsets identified in the brain-specific panel. finally, cd +/ + evs, derived from t-cells and identified in the endothelial/t cell panel, are significantly lower in patients suggesting cns recruitment. summary/conclusion: endothelial and platelet/erythrocyte evs may be elevated early after tbi. s bcarrying evs are significantly elevated in circulation of tbi patients; if reproducible, this signature profile may be informative for diagnosis and risk stratification. further study is warranted to evaluate whether this expression correlates with secondary microvascular brain injury. funding: intramural award from the university of pennsylvania enrichment of mir- a in cns extracellular vesicles following impairment of the blood brain barrier nasser nassiri koopaei a , ekram-ahmed chowdhury b , lais da silva a , jinmai jiang a , behnam noorani b , ulrich bickel b and thomas d. schmittgen a a university of florida, gainesville, usa; b texas tech university, amarilo, usa introduction: extracellular rnas (exrnas) are present in essentially all biofluids and include all types of rna including mirna. to enhance their stability outside of the cell, exrnas are bound within ribonucleoprotein complexes or packaged into extracellular vesicles (evs). the blood brain barrier (bbb) is a dynamic interface between the systemic circulation and the cns and is responsible for maintaining a stable extracellular environment for cns cells. the intent of this study was to determine if evs and their contents are transferred from the peripheral circulation to the cns under conditions of an impaired bbb. methods: the bbb of mice was disrupted by hyperosmolar mannitol injections. to validate that the bbb has been disrupted with mannitol, intravenously-dosed [ c]-sucrose was increased in the forebrain by fold with mannitol compared to sham treated mice. evs were isolated from the forebrain, hindbrain and spinal cord following gentle tissue lysis and differential ultracentrifugation. evs were validated by nta, tem and western blotting. mir- a, a mirna that is highly abundant in erythrocytes, was measured in the evs by qpcr. results: qpcr showed that mir- a in cns tissue evs increased with mannitol treatment in the forebrain, hindbrain and spinal cord by -, . -and twofold respectively. qpcr analysis of mrna from reported mir- a target genes showed reduced target gene expression with mannitol. summary/conclusion: we demonstrate that evs containing mir- a, a highly abundant mirna present within erythrocytes and erythrocyte evs, is enhanced in the cns upon bbb disruption. astrocyte-derived extracellular vesicles in morphine tolerance guoku hu, rong ma, naseer kutchy, yuetong zhao, susmita sil and shilpa buch university of nebraska medical center, omaha, usa introduction: opiates, such as morphine are used extensively in the clinical setting owing to their beneficial effects. paradoxically, however, the prolonged use of morphine often results in the development of tolerance, drug addiction, and ultimately leading to various comorbidities associated with drug abuse. although great efforts have been made, at present there is no treatment. the sonic hedgehog (shh) plays a key role in brain development, and brain cells fine-tuning processes such as their proliferation, patterning, and fate specification recent findings have demonstrated that inhibition of the shh signalling prevents morphine tolerance in rodent models. we thus hypothesize that extracellular vesicles (evs) derived from morphine exposed astrocytes and their cargo such as shh are critical for the development of morphine tolerance. methods: mice were received either saline or chronic morphine injection with escalating doses of morphine for days (subcutaneously; mg/kg, day , mg/kg days - , and mg/kg days [ ] [ ] . the development of tolerance was assessed by measuring the tail-flick latency using tail flick analgesia metre (le , harvard apparatus). evs were isolated using either differential ultracentrifugation from astrocyte conditioned media or gradient ultracentrifugation from brain tissues. western blotting and qpcr were performed to determine the expression/activation of shh signalling pathway components. results: our data showed that the levels of shh protein were upregulated in morphine exposed astrocytederived extracellular vesicles (morphine-adevs). furthermore, shh containing morphine-adevs activated shh signalling in astrocytes. our in vivo study further demonstrated the upregulation of shh, as well as the activation of shh signalling, in astrocytes of morphine-administered mice. summary/conclusion: these findings thus demonstrated an autocrine mechanism for shh pathway activation in astrocytes associated with morphine tolerance. these findings could pave the way for the development of shh signalling pathway targeted strategies in the prevention and treatment for substance use disorders. biophotonics-based platforms for the evaluation of circulating extracellular vesicles as biomarkers of neurodegeneration in alzheimer's disease silvia picciolini a , cristiano carlomagno a , alice gualerzi a , monia cabinio a , francesca baglio a and marzi bedoni b a irccs fondazione don carlo gnocchi, milan, italy; b irccs fondazione don carlo gnocchi, milano, italy introduction: in the search for novel and non-invasive biomarkers of alzheimer's disease (ad), both circulating brain-derived extracellular vesicles (evs) and whole serum represent a valuable integration of the currently used classification system. to face the technological challenge of evs and serum analysis, we propose the use of biophotonics techniques as reliable, sensitive, fast and label free methods, potentially useful in tailoring pharmacological and rehabilitation treatments. methods: circulating evs, isolated by sec, and serum samples were collected from healthy subjects (hc) and ad patients. all subjects were asked to complete montreal cognitive assessment scale and mri examination. surface plasmon resonance (spr) was performed in order to detect evs coming from neurons, astrocytes, oligodendrocytes and microglia and to characterize each of them for the amount of ganglioside m (gm ), aβ and tspo expressed on their surface. serum analysis was performed using a raman microscope through the surface enhanced raman spectroscopy (sers) effect by mixing serum with ag nanoparticles. the pearson's correlation index was used to assess the linear correlation between spri data and clinical, mri data and data obtained from multivariate analysis (mva) of sers spectra. results: the spr analysis of evs showed that the selected bioactive molecules are differently loaded on neural ev populations and that their amount is increased on total evs in ad patients compared to hc. we observed a significant correlation between mva data from sers and the presence of aβ on neuronal and microglial evs and of tspo on neural evs, measured with the spr array. summary/conclusion: thanks to our methodological innovation we have verified the potentiality of evs as ad biomarkers, correlating biophotonics blood-based analysis with clinical data. this platform could provide a powerful tool for the evaluation of ad neurodegeneration. funding: the study was supported by the italian ministry of health (ricerca corrente - to irccs fondazione don carlo gnocchi). raman profiling of extracellular vesicles as new blood-based biomarker for brain disorders: focus on parkinson's disease introduction: extracellular vesicles (evs) play a pivotal role in brain homoeostasis and intercellular communication in both physiological and pathological conditions. in parkinson's disease (pd), evs are key players in the transfer of α-synuclein, with blood evs reported to undergo proteomic modifications. nonetheless, the detection and characterization of the ev cargo is technologically challenging, limiting the use of evs as biomarkers so far. herein, we propose raman spectroscopy for the label-free, bulk characterization of blood evs in pd patients. methods: evs were isolated by sec and ultracentrifugation from the serum of healthy subjects (hc) and pd patients. in all patients, the severity of pd was evaluated with the unified parkinson's disease rating scale (updrs) part iii and with hoehn and yahr scores (hy). after proper ev characterization following misev guidelines, raman analysis was performed. the raman microspectroscope was used with a nm laser in the spectral ranges - cm- and - cm- . data from hc and pd patients were compared by multivariate statistical analysis (pca-lda). results: the raman analysis of evs highlighted differences in the biochemical profile of the two groups, with the main variations in the spectral regions related to proteins, lipids and saccharides. a preliminary estimate of the accuracy of raman profiling of blood evs for pd diagnosis was obtained, demonstrating an accuracy of %. even more interestingly, we demonstrated the correlation between the raman spectra and the clinical scales (updrs and hy) used to stratify pd patients. summary/conclusion: in conclusion, the biochemical signature of blood evs can be detected by raman spectroscopy in pd patients and the ev spectral modifications can be related to their clinical status. these data suggest the possibility to use the raman profile of circulating evs as a biomarker for brain disorders, complementary to other specific molecular markers. funding: the study was supported by the italian ministry of health (ricerca corrente to irccs fondazione don carlo gnocchi) impact of circulating extracellular vesicles on brain functions and behaviours introduction: peripheral immune alterations have been described in psychiatric disorders such as schizophrenia, depression, and autistic spectrum disorders. in addition, behavioural changes have been observed in various immunodeficient animal models. however, the mechanisms by which peripheral immune system influences brain development and function are not well understood. in this study, we explored the mechanisms by which circulating extracellular vesicles (evs) mediate immune-brain communication and influence mouse behaviours. methods: mice deficient for rag or rag gene (rag ko mice) were used as a model to study the effects of loss of adaptive immune cells (t and b cells) on brain cellular phenotypes and behaviours. circulating evs were collected from their sera and analysed by using electron microscopy, nanoparticle tracking assay, and western blotting. brain cellular phenotypes were assessed by immunofluorescent staining and gene expression analysis. behavioural phenotypes of rag ko and wt mice were examined in social interaction test. in vivo transfer of evs was performed to see its effects on behavioural alterations of rag ko mice. results: rag ko mice displayed social behavioural deficits, accompanying by enhance c-fos immunoreactivity and altered microglia morphology in the medial prefrontal cortex (mpfc). circulating evs were also affected in these mice and lacked the expression of markers for t cells. a set of micrornas (mirnas) in circulating evs were diminished in rag ko mice. in vivo transfer of circulating evs rescues the social behavioural deficits of rag ko mice and ameliorate the c-fos immunoreactivities in mpfc of rag ko mice. summary/conclusion: our data showed that circulating ev profiles were altered in mice lacking adaptive immune cells and, accordingly, showing social behavioural deficits. notably, our in vivo experiments suggest that circulating evs may contribute to social behaviours. further study will provide a novel biological insight into the mechanisms underlying peripheral-to-brain immune communication via evs. introduction: the involvement of neuroinflammation on ageing process is widely recognized. extracellular vesicles (evs), such as exosomes, are able to cross the blood-brain barrier and were related to neuroinflammation. in this context, evs have been considered a potential mechanism of spreading molecules, including micrornas (mirnas) that can promote mrna degradation or inhibit translation of their targets. our aim was to investigate the mirna profile of circulating total evs during ageing process and their impact on canonical pathways. methods: the local ethics committee (comissão de Ética no uso de animais -ufrgs; n ) approved all animal procedures and experimental conditions. plasma was obtained from wistar rats ( and months-old) and total evs were isolated. ev microrna isolation and microarray expression analysis was performed to determine the predicted regulation of targeted mrnas. results: the analysis of global microrna expression revealed differentially expressed micrornas (p < . ; fold change of ≥ | . |); mirnas were up-regulated and were down-regulated in circulating total evs from aged animals compared to youngadult ones. a conservative filter was applied on ingenuity pathway analysis (ipa) and only experimentally validated and highly conserved predicted mrna targets were used. ipa showed that neuroinflammation signalling is ranked among the top canonical pathway impacted by differentially expressed micrornas and is upregulated in aged animals (p < . ; z-score: . ). the differentially expressed mirnas impacted molecules in the neuroinflammation pathway. interestingly, the ion channel grin b is predicted to be up regulated and is a target of many evs mirnas; in accordance with our results grin b was previously related to neurodegenerative diseases. moreover, let- a- p is predicted to be downregulated and target all the molecules of the neuroinflammation signalling pathway. previous studies have correlated let- a- p and neurodegenerative diseases. summary/conclusion: our data suggest that circulating total evs cargo, specifically mirnas, are altered by ageing and impact neuroinflammation pathway, suggesting the involvement evs mirna on ageinginduced susceptibility of neurodegenerative diseases. introduction: bidirectional cell-cell communication via paracrine mechanisms is critical for wound healing. a new paradigm involving exosome-borne distinctive repertoire of cargo such as mirnas has emerged as a predominant mechanism of cellular communication at the site of injury. unlike other shedding vesicles of similar size, exosomes selectively package mirna by sumoylation of heterogeneous nuclear ribonucleoprotein (hnrnp). methods: keratinocyte-derived exosomes (exoκ) were genetically labelled with fluorescent reporter (gfp) using tissue nanotransfection. purified, gfp-labelled exoκ were isolated from dorsal murine skin and wound-edge tissue by differential ultracentrifugation followed by affinity selection using magnetic beads. distributions of intact exosome were analysed using a prototype jarrold-geometry charge-detection mass spectrometer to directly measure differences in particle mass and charge distributions. complementary ms and ion mobility spectrometry (ims)-ms experiments have been used to characterize surface glycans and glycopeptides. to selectively inhibit mirna packaging within the exoκ in vivo, ph-responsive targeted sirna functionalized lipid nanocarriers (tlnκ) were designed using materials that have prior history of fda approval for human use. results: an increase in mass/charge ratio with glycan binding sites on the surface of wound-edge exoκ were observed compared to dorsal skin exoκ. wound-edge exoκ were selectively taken up by the macrophages in the granulation tissue (n = ). keratinocyte targeting sirnahnrnp functionalized lipid nanocarriers (tlnκ) were designed with encapsulation efficiency of . %. application of tlnκ encapsulating sirna of hnrnp (tlnκ/si-hnrnp) to murine dorsal woundedge significantly inhibited the expression of hnrnp by % in epidermis compared to control (tlnκ/sicontrol)(n = ). moreover, mice treated with tlnκ/si-hnrnp showed impaired barrier function, with significant presence of macrophage in granulation tissue at day , suggesting impaired conversion of macrophage in the granulation tissue. summary/conclusion: this work provides a novel insight wherein exosomes of keratinocyte lineage are recognized as a major contributor that directs macrophage conversion in granulation tissue for wound healing. multifaced effects of milk-exosome (mi-exo) as modulator of scar-free wound healing gna ahn, hyo-won yoon, yang-hoon kim and ji-young ahn chungbuk national university, cheong-ju, republic of korea introduction: recently, milk exosome (mi-exo) has been focused particularly on the possibility of oral distribution for therapeutic agents. however, studies related to the cosmeceutical effects associated with mi-exo are fairly limited. the purpose of this study is to suggest the anti-oxidant and antiinflammatory effect of mi-exo and possibility that can be induced by scar free healing by micro rna in mi-exo. methods: the characteristics of the extracted mi-exo were verified by size measurement, morphological characteristics through cryo-em and western blot. for antioxidant experiments, an abts assay was performed. next, mrna expression through four major cytokines (tnfα, il- , cox- , inos) was used to evaluate anti-inflammatory effects. finally, cell migration assay was performed to confirm the effect of scar-free healing and the detection of mir- b in mi-exo and vegf mrna expression confirmed. results: mi-exo using % acetic acid extraction showed the highest yield. the average size of the exosomes is approximately nm, confirmed the typical double membrane vesicle. as a result of antioxidant experiments, it was confirmed that the treatment of exosomes of ^ particles showed about % antioxidant activity. when ^ particles were treated, rna expression of cytokines showed about times more inhibitory effect than control. elisa test results also confirmed that the concentration-dependent decrease. the activation of the raw cell less proceeded as the treated mi-exo increased. the cell scratch assay cells did not close the cells as the number of milk exosomes increased (wound closing % of ^ particle = . %). and mir- b in milk exosomes was detected at ct value = . summary/conclusion: the antioxidant and antiinflammatory effects of mi-exo showed the greatest efficacy when ^ particles were treated. in addition, it induced to scar free healing rather than wound healing. mi-exo has great potential as a superior natural material in the future cosmeceutical field. extracellular vesicles in human milk expose tissue factor and promote coagulation introduction: tissue factor (tf), a transmembrane protein, initiates coagulation by binding and activating coagulation factor vii (fvii). tf is associated with extracellular vesicles (evs) in saliva and urine, but it is unknown whether also human milk (hm) contains evs exposing coagulant tf. methods: hm was collected from six healthy nursing women with informed consent. evs were isolated by ultracentrifugation and size exclusion chromatography (sec). the presence of tf antigen exposing evs was studied by western blot, flow cytometry, cryo-electron microscopy (cryo-em), and surface plasmon resonance imaging (spri). the ability of tf exposing evs to trigger coagulation was investigated with a plasma fibrin generation test (fgt), performed in the absence or presence of antibodies against tf or fvii(a). results: addition of hm to plasma shortened the plasma clotting time, even when hm was highly diluted. after ultracentrifugation of hm, both tf antigen and tf activity were detected in the ev-containing pellet. after sec, tf antigen and tf activity were present in the ev-containing fractions and . the presence of tf-exposing evs in these sec fractions was confirmed by western blot (cd , cd and tf), flow cytometry, spri, and fgt. in addition, the presence of evs in hm was confirmed by cryo-em. scalable isolation of evs from different probiotic strains with potential as cosmetic ingredients laura soriano-romaní, joaquin espí and begoña ruiz ainia, paterna, spain introduction: extracellular vesicles (evs) are increasing their application in a number of fields. recently, it has been shown that skin health may be affected not only by commensal skin bacteria, but also by the evs that they secrete. however, because most of the efforts have been directed to the characterization and evaluation of evs, the scaling up of the production process remains a bottleneck at the industrial level. in this work, the goal was to evaluate the potential applications of evs produced by different probiotic strains commonly used in the cosmetic field, considering the economic and technical viability of the process. methods: to meet our goal, a standardized workflow was defined to isolate evs from probiotic strains such as lactobacillus and bifidobacterium species, that have demonstrated cutaneous immuno-regulatory effects. the different bacterial strains were produced under standard culture conditions. to isolate the secreted bacterial evs, different chromatographic techniques were performed starting from clarified growth medium. then, evs were evaluated in vitro for a number of biological effects related with skin health. results: the ev yields obtained after downstream processing were calculated for each strain and isolation technique by means of nanoparticle tracking analysis (nta) and total protein content. moreover, evs were visualized by electron microscopy. the in vitro evaluation of isolated evs was based on changes in the expression of five biomarkers related with anti-ageing, anti-inflammatory and whitening effects using distinct skin cell types to identify possible cosmetic claims that could be associated to each probiotic source. summary/conclusion: the potential of evs obtained from probiotic strains as cosmetic active cell-free ingredients was preliminarily assessed with this work, where the process yield and cosmetic function were evaluated. however, additional experiments will be needed in order to increase and optimize the productivity of each step of the ev manufacturing process. acerola derived exosome-like nanovesicles enhances the repair of ultraviolet b-induced dna damage in cultured skin fibroblasts tomohiro umezu, masakatsu takanashi, yoshiki murakami and masahiko kuroda tokyo medical university, shinjyuku, japan introduction: acerola (melpighia emarginata dc.) is a fruit is known to contain not only high amounts of ascorbic acid but also various nutritional components such as carotenoids and polyphenols. previous reports showed the acerola juices are able to confer protection against ultraviolet radiation b (uvb), to improve barrier function of skin. uvb is the main cause of dna damage in epidermal cells, generating several types of pro-mutagenic lesions, like cyclobutene prymidine dimers (cpds) and prymidine ( - ) prymidinone photoproducts ( - pps): if not repaired, this dna damage leads to skin cancer. in this study, we investigated the biological property of the acerola derived exosome-like nanovesicles (adens), aiming to clarify the involvement of adens in repair of uv-induced dna damage. methods: normal human dermal fibroblasts (nhdfs) were purchased from lonza inc. the exosome-like nanovesicles were isolated from acerola juices using exoeasy maxi kit (qiagen). the morphology and size distribution of adens were checked by transmission electron microscopy (tem) and nanoparticle tracking analysis (nta, nanosight lm , malvern). nhdfs were exposed to uvb ( mj/cm ) with pre-or post-adens. effect of uvb was assessed by examining cell viability, cell morphology, and dna damage levels through biochemical assays, microscopy and protein expression studies. results: purified adens were compatible with nta or tem for assessing the nanovesicle size range and concentration ( - nm). when nhdfs were added with adens and incubated at °c for h, there was no effect of adens on cell proliferation of nhdfs. we found that adens treatment to uvb exposed nhdfs significantly reduced cpds and - pps dna adduct formation. present results showed that aden treatment prevented uvb induced dna damage in nhdfs. summary/conclusion: we confirm that adens have the effect of repairing dna damage caused by uvb. these results provide that adens can be a new source to protect human skin from uv-induced skin cancer. introduction: introduction: despite the development of a variety of therapies, complex wounds resulting from disease, surgical intervention, or trauma remain a major source of morbidity. extracellular vesicles (evs) derived from mesenchymal stem/stromal cells (mscs) have been shown to improve wound healing, especially via enhanced wound angiogenesis. however, despite their clearly established potential, evs have limitations that may limit clinical relevancy, such as low potency. hypothesis: increased expression of pro-angiogenic lncrna hotair within msc evs enhances their proangiogenic effects and thus their wound healing properties. methods: methods: hotair was overexpressed in human dermal microvascular endothelial cells (hdmecs) to determine any molecular or functional pro-angiogenic effects. anti-angiogenic mirnas and angiogenic mrna levels were quantified by rt-qpcr. effects of hotair on proliferation of hdmecs was also determined. hotair was then loaded into msc evs by delivering a cmv-based hotair plasmid to mscs for endogenous loading via a concentration gradient. evs were collected by differential centrifugation. hotair content within evs was confirmed by gel electrophoresis and rt-qpcr. effects on migration of hdmecs by hotair-loaded msc evs were determined using a scratch assay. results: results: overexpression of hotair decreased mir- c and mir- , while increasing vegf and hif- a. hdmec proliferation was also increased in hdmecs overexpressing hotair (p < . ). hotair was visually confirmed in hotair-loaded msc evs by gel electrophoresis, but was undetectable in unmodified msc evs. rt-qpcr confirmed a -fold increase of hotair compared to control msc evs. hdmecs showed a more statistically significant rate of gap closure when treated with hotair-loaded evs (p < . ) than compared to control msc evs (p < . ). summary/conclusion: summary: loading lncrna hotair into msc evs is achievable by a concentration gradient-dependent method and offers potential to enhance the angiogenic properties of msc evs. nanomaterial labelling of exosomes for cell biology introduction: exosomes are vesicles secreted by many, if not all, cell types and have been known about for decades. among larger micro vesicles that are produced directly from the cell membrane, the small ( - nm), exosomes are similar in size to a virus surrounded by a lipid bilayer. we and others have demonstrated that exosomes contain proteins, lipids, rna, and dna, making them promising materials for diagnosing and treating diseases, including many cancers such as brain cancer. in addition, exosomes from neurons and glial cells represent a novel type of intercellular communication. however, their size makes them hard to track with traditional fluorescence microscopy. to address this, we developed photothermal microscopy (ptm), which uses gold nanomaterial labelling to track exosomes' interaction with and effect on cells/tissue. methods: exosomes secreted by tumour cells and general exosomes found in the blood were isolated using differential ultracentrifugation or a commercially available kit (invitrogen). next, the exosomes were characterized by (tem), (nta), and western blotting to determine shape, size, morphology and the protein profile in the exosomal membrane. after characterization, the exosomes were labelled with gold nanoparticles via sonication. next, the samples were washed, and the exosomes were labelled with fluorescence dye to stain the membrane. after staining and labelling, the exosomes were added to u cells in culture and incubated for h. they were then fixed by % paraformldehyde and imaged by ptm. results: ptm found that exosome-cell interactions are exosome-type dependent, as u cells took up exosomes from other u cells but not human serum exosomes. this suggests that exosome uptake is a selective process and depends on the source of the donor cells. summary/conclusion: exosomes can be labelled with gold nanoparticles via sonication then successfully tracked by ptm to study the effect of exosome source on exosome-cell interactions and communication. cells incubated with u exosomes took the vesicles up rapidly, while cells incubated with serum exosomes had little uptake. ptm will help us design selective exosome-based strategies to treat different conditions, including brain cancer and cns damage. funding: nsf epscor riii award . loading of goat´s whey extracellular vesicles with spiked microrna and curcumin as an strategy for developing new nanocarriers for acellular therapies introduction: extracellular vesicles (ev) are involved in cell signalling and are present in a variety of cell secretions such as milk, from which enormous amount of ev can be purified, thus milk is an attractive raw material for scaling up ev production for therapeutic, cosmetic or other uses. here we isolated evs from the whey fraction of goat´s milk and demonstrated that such evs can be loaded with molecules like polyphenols and mirna. methods: to achieve this, milk was collected from lactating goats and fractionated by acidification and centrifugation into whey and caseins. evs were purified from the former fraction by serial centrifugation and precipitation with commercial kit (total isolation/ thermo fisher) and characterized by electron transmission microscopy (tem), western blot to identify surface markers and measurement of size through nanotracking analysis. once isolated, evs were loaded with different concentration of a spiked synthetic mir or with the polyphenol curcumin. mirna or curcumin were co-incubated over night with evs at oc, precipitated and purified as described above, with an additional washing and precipitation for curcumin. concentration of mirna uploaded by evs was quantified using mir specific qpcr. curcumin was measured using a spectrophotometer at nm. results: evs isolated from whey had an average size of nm, were positive for hsp , cd and alix. in tem, evs were identified with their natural conformation and corresponding size to exosomes. qpcr showed a significant difference of expression of mir in relation to control (loaded with shame) and the negative control (p < . ). curcumin presence was also confirmed after washing and precipitacion. summary/conclusion: in conclusion, milk evs and exosomes can be loaded with mirna and a polyphenol and can be used as alternative nanocarrier for acellular therapies. introduction: extracellular vesicles (evs) are cellderived lipid membrane nanoparticles that serve as messengers of intercellular communication, transferring bioactive molecules to recipient cells. evs have a natural therapeutic potential with high flexibility and biosafety for employing natural and synthetic biomolecules as therapeutic delivery vehicles. considering the importance of evs, their isolation methods are still a bottleneck. to get insights into the tissue-specific cargo in vivo for complete exploitation of evs as therapeutic, biomarker and diagnostic tools, ev purification methods are critical. the aim of the study was brought about to develop an efficient ev purification method both in vitro and in vivo and to further investigate function of evs in cellular senescence. methods: to isolate tissue-specific evs in vivo we developed recombinant evs by genetically fusing snorkel-tag to the cd . the snorkel-tag enables on-column protease treatment for purifying evs which does not rely on traditional immunoaffinity purification protocols using low ph or high salts solutions. results: we systematically evaluated the purification of evs harbouring snorkel-tag by employing different methodologies. our findings suggest that evs harbouring snorkel-tag indeed can be purified at high purity without altering ev biophysical properties. furthermore, we expressed cd -snorkel-tag under p ink a promoter and were able to purify evs derived from senescent cells. summary/conclusion: finally, we are developing an in vivo model with cd -snorkel-tag under p ink a promoter. this will provide us detail insights into the ev cargo secreted from senescent derived cells, by purifying evs harbouring snorkel-tag under pathophysiological conditions, allowing us to develop biomarkers and therapeutic tools. summarized, we have here developed novel tool for studying content and function of evs in the context of ageing and disease. this tool will now pave the way for studying the molecular mechanisms underlying these ev functions in vivo. funding: this work was funded by the austrian science fund phd program biotopebiomolecular technolgy of proteins (w ). engineering exosomes with gata- jie xu, christian paul, yi-gang wang and meifeng xu university of cincinnati, cincinnati, usa introduction: exosomes, are small vesicles ( - nm) secreted from cells that can transport and deliver of their components such as lipids, proteins, dna, mrna, and mirna to target cells. gata- , a cardiac transcription factor, has been shown to regulate differentiation, proliferation, and survival of a wide range of cell types. delivering gata- protein into ischaemic tissues may be one of the most straightforward approaches to improve cardiac function following myocardial infarction. here, exosomes were engineered with gata- by infusing gata- with exosome targeting peptide. methods: the open reading frame of mouse gata- cdna was ligated to xpack lentivirus vector (xpack-gata- ) and plvx-ef -ires-pouro lentivirus vector (plvx-gata- ), respectively. hek cells were transduced by lentivirus, then exosomes were isolated from conditioned medium of hek cells using ultracentrifugation. exosomes were identified using transmission electronic microscope (tem), and the expression of gata- was semi-quantified using western blot. the internalization of exosomes was tracked via treating bend cells with exosomes pre-labelled with pkh . introduction: chinese hamster ovary (cho) cells have dominated as the mammalian cell host for the manufacture of humanized biologics, in part owing to their genomic plasticity and robust growth in suspension culture. there is great interest surrounding the use of extracellular vesicles (evs) as novel therapeutics owing to their capacity to deliver bioactive molecules. however, much remains unknown about the mechanisms involved in ev cargo loading, limiting their development as novel biologics. to this end, we have engineered cho cells to stably express constructs enabling loading of gfp into evs. methods: tetraspanins are established markers of ev identity. accordingly, cd was selected as a tethering point to generate evs with gfp cargo and constructs were generated via golden gate assembly. cho cells were stably transfected by electroporation and expression was verified with fluorescence microscopy and western blotting. growth in batch culture was monitored to establish maximum viable cell densities for ev harvest and recovered evs were characterized by nanoparticle tracking analysis (nta). finally, uptake of gfp-evs was studied using time-lapse fluorescence imaging in co-culture experiments. results: strong localization of cd -gfp was observed at the cell membrane and blotting confirmed intact tetraspanin fusion present at the expected molecular weight. additionally, cells were confirmed to retain high gfp expression post-cryopreservation. stable cell pools were able to reach viable densities greater than million cells/ml in batch culture and nta allowed for detection of gfp cargo even prior to ev isolation. evmediated transfer of functional gfp to recipient cells was found to occur over a period of hours. introduction: extracellular vesicles (evs) are considered promising for therapeutic applications. evs resemble the cell membrane, allowing high biocompatibility to target cells, while their small size makes them ideal candidates to cross biological barriers. despite the promising potential of evs for therapeutic applications, robust manufacturing processes that would increase the scalability and consistency of ev production are still lacking. methods: in this work, evs were produced by mesenchymal stromal cells (msc), isolated from different human tissue sources (bone marrow, umbilical cord matrix and adipose tissue). msc were selected as these cells allow for a scalable production of evs, while displaying low immunogenicity. a vertical-wheel™ bioreactor system was implemented for the production of msc-derived evs and compared with traditional static systems. the obtained ev products were characterized by nanoparticle tracking analysis, atomic force microscopy, zeta potential and western blot. results: the bioreactor system allowed to obtain evs at higher concentration and productivity, as well as more homogeneous size distribution profiles, when compared to traditional static culture systems. functional studies were performed using breast cancer and lung cancer cell lines. proliferation assays allowed to determine the dose-response profiles of these cell lines when exposed to msc-derived evs. a bell-shaped profile was observed for most cases, since raising the ev concentration lead to increased cell proliferation until a certain point ( - µg/ml), after which cell proliferation was attenuated with increasing ev concentrations. summary/conclusion: the bioreactor culture system allowed a substantial improvement in the production of msc-derived evs, while the obtained dose-response profiles will be valuable to determine the most appropriate ev concentrations for anticancer drug delivery. overall, we demonstrate that this culture system is able to robustly manufacture human msc-derived evs in a scalable manner towards the development of novel therapeutic products such as anticancer drug delivery systems. biodistribution and cellular location of inhaled exosomes and liposomes in the lung introduction: increasing evidence reveals the potential role of extracellular vesicles, such as exosomes and liposomes, in lung regenerative medicine for the treatment of lung diseases. encapsulation and delivery of potential rna and microrna targets into liposomes and exosomes are attractive drug delivery methods, but remain difficult to deliver to the pulmonary parenchyma to reach target lung cell types. here, we demonstrate effective delivery and cellular uptake of exosomes and liposomes to the pulmonary parenchyma via inhalation treatment in a murine model of idiopathic pulmonary fibrosis. methods: human lung stem cells (lscs) were generated and expanded from healthy whole lung donors. lsc-exosomes were purified via ultrafiltration and diilabelled using vybrant☐ labelling solution according to the manufacturer's instructions. dsred-labelled liposomes were generated using lipofectamine™ rnaimax transfection reagent and block-it™ alexa fluor™ red fluorescent control according to the manufacturer's instructions. lsc-exosomes and liposomes were delivered via nebulization to cd mice with bleomycin-induced pulmonary fibrosis. exosome and liposome delivery and biodistribution were visualized -and -hours post-treatment through histological analysis. the study was approved by the institutional animal care and use committee of north carolina state university and complied with all national and state ethical standards. results: exosome and liposome delivery to the pulmonary parenchyma was confirmed by the presence of dii and dsred fluorescence in lung histological sections that penetrated the mucus-lined respiratory epithelium. more exosomes and liposomes surpass mucus-lined surfaces -hours post-treatment compared to -hours post-treatment. fluorescent colocalization of exosomes and liposomes with alveolar type i cells, alveolar type ii cells, basal lung cells, and cd + macrophages was observed through immunohistochemistry analysis. more exosomes and liposomes colocalize with these cell types -hours post-treatment compared to -hours post-treatment. summary/conclusion: lsc-exosomes and liposomes penetrate the mucus-lined respiratory epithelium and reach the pulmonary parenchyma through inhalation treatment. lsc-exosomes and liposomes are uptaken by alveolar epithelial cells, basal cells, and interstitial macrophages with improved biodistribution -hours post-treatment. funding: this study was supported by the nc state chancellor's innovation fund. transfection reagent artefact accounts for some reports of extracellular vesicle function codiak biosciences, cambridge, usa introduction: extracellular vesicle (ev) functions are frequently investigated by transiently transfecting cells with plasmid dna to produce evs modified with protein(s) or nucleic acid(s) of interest. however, evs and the dna-complexes used to transduce cells are physically similar, raising the possibility that they may co-purify during differential ultracentrifugation, the most common ev isolation procedure. activities attributed to evs may therefore be due to contaminating dna -transfection reagent complex. methods: ev producing cells were transiently transfected with plasmid dna encoding gene-editing or split enzymes fused to ev-targeting protein sequences. differential and density gradient ultracentrifugation were used to purify evs from cell culture supernatant or dna lipoplexes from cell-free culture media. protein expression and localization to evs was confirmed by western blot. cell lines stably expressing fluorescent or luminescent reporters were used to assess functional enzyme delivery in recipient reporter cells. results: reporter cells treated with ultracentrifuge pellet material (ucp) from media of transiently transfected cells showed robust and reproducible signal, however fractionating the ucp with an iodixanol density gradient revealed that reporter activity was associated with high-density fractions that were depleted in evs. ucp isolated from identical transfection conditions, but lacking cells (and exosomes), showed identical biological activity levels and distribution in iodixanol gradients, suggesting that the activity was due to contaminating transfection reagent complexes and not evs. serial media changes on ev producing cells post-transfection did not significantly reduce ucp activity on reporter cells. treatment with nucleases did not digest complexed dna, did not significantly reduce dna levels in the ucp as measured by qpcr, and did not decrease activity in reporter cells treated with ucp from either transfected cells or no-cell controls. summary/conclusion: we find that dna-transfection reagent complexes are not separated from evs using differential ultracentrifugation and that common approaches to remove such complexes, including media exchanges and nuclease treatment, are ineffective. due to the pernicious nature of the dna-complex in these cellular assays, it is likely that some reports of ev function are likely artefacts produced by contaminating dna-complexes. we find that density gradient centrifugation can effectively separate evs and dnacomplexes, highlighting the importance of validating elimination of contaminating transfection reagent complexes when using transient transfection to interrogate ev function. chair: suresh mathivanan -la trobe university cancer stem cell-derived exosomes: potential biomarkers for early diagnosis and prognosis in pancreatic cancer introduction: pancreatic cancer (paca) is the most deadly manlignancy, due to late daignosis and early metastatic spread, which prohibits surgery. it is urgently for relaible, early detection. research shows that tumour-derived exosomes, which had been present in the blood in the early stage of tumour formation and before metastasis, is the vanguard forces of tumour formation and metastasis; cancer stem cell-derived exosomes (csc-exos) has stronger migration ability, so the detection of blood csc-exos for early diagnosis and monitoring of progress for paca has great research potential and the value of application. methods: protein markers were selected according to expression in exosomes of paca cell line culture supernatants, but not healthy donors' serum-exosomes. according to these preselections, serum-exosomes were tested by flow cytometry for the pancreatic cancer stem cell marker cd v and tspan . results: the majority ( %) of patients with paca and patients with nonpa-malignancies reacted with anti-cd v and anti-tspan . serum-exosomes of healthy donors' and patients with non-malignant diseases were not reactive. recovery was tumour grading and staging independent including early stages. introduction: chronic traumatic encephalopathy (cte) is a tauopathy that affects individuals with a history of mild repetitive brain injury frequently seen in contact sports. initial neuropathologic change of cte include perivascular deposition of phosphorylated tau (p-tau) in cortical neurons and, in later stages, the formation of neurofibrillary tangles in neurons throughout the brain. extracellular vesicles (ev) are known to carry neuropathogenic molecules in neurodegenerative disease and able to cross the blood brain barrier. we therefore examined the protein composition of ev separated from cerebrospinal fluid (csf) and plasma in former national football league (nfl) players with cognitive dysfunction, and an agematched control group with no history of contact sports. methods: evs were separated from csf and plasma from former nfl players (n = , ) and controls (n = , ) by affinity separation method or size exclusion chromatography, respectively. the ev protein profiling was characterized by simoa for tau and ptau and mass spectrometry. the protein data was analysed for ev enrichment, differentially expressed proteins, pathway analysis and correlation with cognitive function, head impact and tau/p-tau levels by biostatistics and bioinformatics. results: the level of total tau and p-tau in csf evs was not significantly changed, but significantly elevated in plasma evs from former nfl players. the proteins were commonly identified between the paired plasma-csf from the same patients, but there was no significant correlation with disease status. collagen alpha- (vi) chain (col a ), − (vi) chain (col a ) and reelin (reln) were differentially expressed in former nfl players' plasma evs. a combination of these proteins in plasma ev can distinguish former nfl players from controls with % accuracy by machine learning. summary/conclusion: the interacting plasma-csf ev proteomes provide an original resource to ev biomarker development for neurodegenerative disease, and col a , reln and col a in plasma evs can be potential biomarker for monitoring the cte development. density-based fractionation of urine to unravel the proteome landscape of extracellular vesicles in prostate cancer introduction: current diagnostic tests are unable to discriminate indolent from aggressive prostate cancer (pca), leading to overdiagnosis and overtreatment, and an intense interest in biomarkers to improve clinical decision making. urine is considered an ideal proximal fluid for biomarker identification in pca due to its direct contact with the urogenital system. the discovery and translation of extracellular vesicle (ev) content into pca biomarkers remains challenging due to the difficulty of obtaining urinary ev (uev) with high specificity. methods: we developed a step-by-step protocol to separate uev by orthogonal implementation of ultrafiltration and bottom-up density gradient centrifugation (bu-odg). we implemented complementary particle and protein measurements to identify uev (lower density) and protein rich fractions (higher density) and assess the performance of bu-odg (specificity, efficiency and reproducibility). using mass spectrometry-based proteomics we interrogated uev and protein rich fractions from matched urine and radical prostatectomy tissue samples from pca patients (n = ), and urine from men with pca prior to (n = ) and after local treatment (n = ), benign prostatic hyperplasia (n = ) and other urological cancers (n = ). results: bu-odg separated uev from soluble proteins and tamm-horsfall protein (thp) complexes with high specificity and reproducibility, outperforming differential ultracentrifugation, exoquick and size-exclusion chromatography. comparison of the uev proteome from men with benign or malignant prostate disease, allowed us to expand the known human uev proteome and identify a pca specific uev proteome not uncovered by the analysis of the protein rich fraction. proteomic analysis of ev separated from prostate tumour interstitial fluid and matched uev confirmed pca specificity of the uev proteome. analysis of the uev proteome from patients with bladder and renal cancer provided additional evidence of the selective enrichment of protein signatures in uev reflecting their respective cancer tissues of origin. summary/conclusion: we identified hundreds of previously undetected proteins in uev of pca patients and developed a powerful toolbox to map uev and protein rich fractions, ultimately supporting biomarker discovery for urological cancers. immunoglobulin a coating of faeces-derived bacterial vesicles as a marker of inflammatory bowel disease in humans nader kameli a , frank stassen b , heike becker c , john penders c , daisy jonkers d and paul savelkoul b introduction: iga is the most abundant antibody in mucosal secretions and plays a crucial role in maintaining the balance between the host and the gastrointestinal microbiome. recent studies suggested that pronounced iga coating is especially prominent among inflammatory commensals which drive intestinal disease. membrane vesicles (mvs, nano-sized particles released by bacteria) have also been found to interact with the host and modulate development and function of the immune system. however, their interaction with iga has not been studied yet. here we developed a method to isolate and characterize the mvs from faecal samples and checked for possible differences in iga coating patterns of mvs in health and disease. methods: mvs were isolated by using a combination of ultrafiltration and size exclusion chromatography from faecal samples of healthy controls (hc), patients with active crohn disease (cd) and cd patients in a remissive state. quantification and verification have been done with tunable resistive pulse sensing (trpsbased analysis) bead-based flow-cytometer (bbfc) and transmission electron microscope (tem). mvs were selected with specific antibodies for capturing (gram +: lta, gram-: ompa) followed by pe-conjugated anti-human iga antibodies as detection. results: we could successfully isolate * - * particles/ml from mg of faeces. bbfc in combination with trps provide a valuable method for (semi-)quantitative measurements of mixed populations. intriguingly, remarkable differences were found between iga coating mvs derived from healthy controls and active and remissive cd patients as mvs derived from healthy controls were significantly more coated compare to both cd patient groups. in details, for selected g-ve derived mvs: % of the total population of mvs derived from hc were coated, % from remissive cd patients, and < % of active cd patients; and for selected g+ ve derived mvs: % of the total population of mvs derived from hc were coated, % from remissive cd patients, and % of active cd patients. (data are represented as the mean). summary/conclusion: here we demonstrate for the first time that mv isolated from the faecal samples are also coated with iga, and surprisingly mvs from healthy volunteers were more densely coated than mvs from diseased patients. the possible consequence of this difference remains to be determined in future studies. monitoring altered tetraspanin and psma expression in prostate cancer derived extracellular vesicles via advanced image flow cytometry (isx) lukas w. prause a , christopher millan b , natalie hensky c , tullio sulser c and daniel eberli c a universityhospital zurich, zurich, switzerland; b university of zurich hospital, schlieren, switzerland; c university of zurich hospital, zurich, switzerland introduction: new diagnostic and therapeutic options for patients with prostate cancer are urgently needed. prostate-specific membrane antigen (psma)-based imaging and therapy are increasingly used for prostate cancer management. unfortunately, as a membrane protein, psma is not found as a soluble protein in the blood and therefore has limited utility as a diagnostic biomarker. however, psma has reportedly been observed as a cargo protein of prostate cancer-derived extracellular vesicles (evs). we demonstrate altered psma expression on evs derived from prostate cancer cell cultures (c - , lncap) in response to novel next-generation androgen receptor inhibitor (enzalutamide), a standard chemotherapy agent (docetaxel), a novel experimental nonsteroidal antiandrogen (epi- ) that binds covalently to the n-terminal domain of the androgen receptor and dihydrotestosterone (dht). additionally, evs were isolated from the plasma of prostate cancer patients who participated in the prococ biobank campaign at the usz. plasma was taken and stored from patients both pre-and post-prostatectomy. results: transmission electron microscopy, nanoparticle tracking analysis and simple western (wes) analysis show stable size distribution and amount of evs produced by treated and non-treated cells. using advanced image-based flow cytometry, altered tatraspanin and psma expression could be detected in evs isolated from cell culture supernatants of lncap and c - prostate cancer cells following their treatment. summary/conclusion: measuring psma expression on extracellular vesicles might pave the way to use image flow cytometry of evs to develop a blood based diagnostic test for prostate cancer patients with a wide range of possible applications including: ) monitoring response to therapy and, ) early indications of potential relapse. funding: vontobel fondation. proteomic profiling of human neural cells derived extracellular vesicles to identify human brain cell-type specific markers introduction: alzheimer's disease (ad) is a common neurodegenerative brain disease which affects appropriately million patients worldwide. one of the major challenges in ad is to develop reliable biomarkers for early diagnosis and disease-modifying therapies, especially before the clinical symptoms. extracellular vesicles (evs) carry cargos of proteins, lipids and nucleic acids. there was no comprehensive characterization of evs isolated from specific brain cell types, which may be useful for cell type-specific biomarkers. the purpose of this study is to isolate evs from human induced pluripotent stem cell (ipsc)derived brain cells for proteomic profiling and characterization of cell type-specific molecules. methods: human ipscs-derived neurons, microglia and primary cultured astrocytes were differentiated in ev-depleted media. the evs were isolated by differential centrifugation combined with size exclusion chromatography, followed by characterization using nanoparticle tracking analysis and mass spectrometry. the proteomic data were subjected to bioinformatics analysis results: we identified proteins from neuronderived ev (nde), proteins from microgliaderived ev (mde) and proteins from astrocytederived ev (ade) by proteomics. gene ontology analysis indicated that most of these proteins are associated with evs. furthermore, , and proteins are present individually in ndes, mdes and ades. among them, high levels of atp a and syt in ndes, itgam and cd a in mdes, and eaat and gfap in ades were found, all of which are typically and highly expressed in the original cells. summary/conclusion: our results provide us the potential candidates for cell-type specific ev markers, which will be helpful to develop non-invasive tools to enrich ev originating from specific brain cells and may lead to the development of new biomarkers for neurodegenerative disorders. ) are a tremendous resource for extracellular vesicle (ev) research, but they are heavily focussed on mammalian evs, i.e. evs from humans and laboratory animals, where protein cargoes are well characterised, and a wide selection of antibodies are commercially available. protein markers can be used to identify and define the types of mammalian ev and to determine the presence of any contaminants that might confound functional studies. similar resources are not as readily available for bacterial evs as these are not as well characterised, commercially available antibodies are much less abundant and immunological variation between different bacterial species (and there are trillion bacterial species on planet earth!) means that each species, strain, or group of related species may require different antibodies. methods: to identify quality markers for bacterial evs, we have characterised the proteome of cells, crude evs (ultracentrifuge pellet from cell free culture supernatant) and size exclusion chromatography or density gradient centrifugation purified evs from two different (pathogenic vs probiotic) strains of escherichia coli grown under two different environmental conditions, and one strain of mycobacterium marinum grown in one medium. results: our results identify a selection of proteins enriched in purified ev preparations, and proteins that are depleted after purification steps. summary/conclusion: our results allow the identification of potential markers for ev purity and non-ev contaminants, but also highlight the variability in bacterial ev preparations and suggest potential targets that can be used to investigate the heterogeneity of bacterial ev populations. introduction: recent findings indicate an increase in mid-life mortality rates in the usa and persistent, significant race-related health disparities exemplified by differential mortality rates. this suggests that exploring new molecular markers that may be linked to mortality could provide novel insights into factors that are driving mortality rates. accumulating data suggests that extracellular vesicles (evs) circulating in blood may be potential biomarkers of age-related disease. evs are nano-sized membranous vesicles that bear molecular cargo and mediate intercellular communication between different cells and tissues. little is known about whether ev characteristics differ by race or whether evs are associated with clinically relevant mortality risk factors. methods: in this cross-sectional study, plasma evs were isolated from middle-aged african american (aa) and white males and females. results: we report no significant differences in ev size or concentration with race or sex. there were significantly higher ev levels of phospho-p , total p , cleaved caspase , erk / and phospho-akt in whites compared to aas. higher ev levels of phospho-igf- r were found in females compared to males. we examined ev characteristics and protein cargo in the context of well-established clinical mortality risk factors. ev concentration was significantly, and positively, associated with several mortality markers including, high-sensitivity c-reactive protein (hscrp), homoeostatic model assessment of insulin resistance (homa-ir), alkaline phosphatase, pulse pressure, body mass index, and waist circumference. the relationship of ev concentration and cargo with mortality markers differs by race. summary/conclusion: our data show that ev-associated proteins can differ by race and sex and are associated with mortality risk factors. this study provides insight into the characterization of evs in middle-aged aas and whites, which may aid in the development of ev-based diagnostics. funding: this study was supported by the national institute on ageing intramural research program of the national institutes of health. repurposing specialised cell-free dna blood collection tubes for extracellular vesicle isolation introduction: liquid biopsies offer a minimally invasive approach to patient disease diagnosis and monitoring. however, many plasma processing protocols have been designed with a single biomarker in mind. here we investigate whether specialised dna blood stabiliser tubes could be repurposed for the analysis of extracellular vesicles (evs). methods: peripheral blood (n = ) was collected into k -edta, roche or streck cell-free dna (cfdna) blood collection tubes and processed using sequential centrifugation immediately or after storage for days. microev were collected from platelet poor plasma by , g centrifugation and nanoevs isolated using size exclusion chromatography. particle size and counts were assessed by nanoparticle tracking analysis, protein by bca assay and dot blotting for blood cell surface proteins. results: major variations in micro and nanoevs were seen with delayed time to processing. nanoev counts did not change with processing delay or tube collection type but the associated protein amount increased, indicative of cell lysis or activation. the protein was predominantly derived from from platelets (cd ) and red blood cells (cd a). the increase in associated protein was seen more in the k -edta and streck tubes indicating that the roche tubes may offer improved cell stability. conversely, microevs increased in both quantity and protein content with delay to processing indicative of both lysis and cell activation, irrespective of tube type. epithelial cell surface marker epcam abundance remained the same across conditions in both micro and nanoevs demonstrating that epcam+ evs were stable. summary/conclusion: specialised cfdna collection tubes can be repurposed for micro and nanoev analysis, however simple counting or using protein quantity as a surrogate of ev number may be confounded by pre-analytical processing. the evs would be suitable for disease selective ev subtype analysis if the molecular target of interest is not present in blood cells. introduction: nutrigenomics and nutrigenetics have been defined as the effect of nutrients on gene expression and genetic variation on dietary response, respectively. here, we propose the isolation and characterization of exosomes from donors carrying different alleles of hla-dqa and hla-dqb , to investigate their involvement in coeliac disease (cd) management. methods: a chilean population (n = ) was investigated for snps mutations in hla class ii alleles associated to cd predisposition (as well as other mutations related to other food intolerances), using the genochip food technology. exosomes have been isolated from donors' serum by ultracentrifugation and characterized by sds-page, western blotting (cd and cd ), and transmission electron microscopy. exosomes were also studied for their interleukins (il- and il- ra) content. results: among the studied population, % present at least one of the alleles leading to cd development and % carry alleles encoding for αand β-chains heterodimers associated with very high risk to develop cd. in parallel, isolated exosomes from donors with low to extremely high risk for cd showed high il- ra content ( . ± . to . ± . ), as the persons were not following any treatment. however, values of il- ra decrease in exosomes isolated form persons receiving treatment for cd. a relationship between exosomes' content and genetic susceptibility for cd has been observed, which may suggest their possible use as biomarkers for cd as the diagnostic of this disease is still a big issue. summary/conclusion: until this point of this underway project, we demonstrate the existence of a relationship between the exosomes' content in il- ra and genetic susceptibility for cd. furthermore, the genetic predisposition to cd could also modulate the gut colonization process, another important player in intestinal homoeostasis. in the next step, extracellular vesicles from gut microbiota will be isolated and analysed to determine their role in cd management. nasibeh karimi a , razieh dalir fardouei a , jan lötvall a and cecilia lässer b a krefting research centre, institute of medicine, sahlgrenska academy at university of gothenburg, göteborg, sweden; b krefting research centre, institute of medicine, sahlgrenska academy at university of gothenburg, gothenburg, sweden introduction: the ability to isolate extracellular vesicles (evs) from blood is vital in the development of evs as disease biomarkers. both serum and plasma can be used but few studies have compared them in terms of amount and type of evs. we have previously developed a method to isolate evs from plasma with minimal contamination of lipoprotein particles (karimi et al ) . the aim of this study was to compare the presence of different subpopulations of evs in plasma and serum. methods: blood was collected from healthy subjects, from which plasma and serum were isolated. evs were isolated using a combination of density cushion and size exclusion chromatography (sec) (protocol ) or a combination of density cushion and density gradient (protocol ) or immune-capturing (anti-cd , anti-cd and anti-cd beads) (protocol ). purity and yield of evs were determined by nanoparticle tracking analysis (nta), western blot, electron microscopy (em), exoview, flow cytometry and mass spectrometry (lc-ms/ms). results: as determined by nta and protein measurement more evs could be isolated from plasma with protocol and the majority of the vesicles were cd / cd a positive as determined with exoview and western blot. additionally, flow cytometry and western blot showed that more cd /cd a positive evs where also identified with protocol . furthermore, western blot showed increased amount of cd a in plasma samples in protocol . when labelled evs were spiked in freshly collected blood, no difference in recovery was seen for plasma and serum. summary/conclusion: this study shows that a larger amount of evs could be isolated from plasma compared to serum when three different isolation methods were used. firstly, this suggests that more evs are present in plasma. secondly, it suggests that these vesicles are probably released by platelets and that evs are not trapped in the clot during serum formation. future studies are needed to answer how this affects the use of blood-derived evs as biomarkers from serum and plasma. tumour-derived extracellular vesicles contain distinct integrin proteins stephanie n. hurwitz a and david g. meckes b a university of pennsylvania, philadelphia, usa; b florida state university, tallahassee, usa introduction: cargo profiling, including proteomic analyses, of tumour cell-derived extracellular vesicles (evs) may provide ripe opportunities for further understanding cancer growth, drug resistance, and metastatic behaviour. accumulating data suggest that cancer-derived evs contain membrane-bound integrin proteins which may aid in cell detachment, migration, and homing to future metastatic niches. we have previously published an extensive proteomic profile of secreted vesicles from the nci- panel of human cancer cells. methods: here, we further examine the distinct integrin components in these cancer-derived evs, and additionally profile evs released from benign epithelial cells by liquid chromatography and tandem mass spectrometry for comparison. results: we demonstrate the enrichment of integrin receptors in cancer evs compared to vesicles secreted from benign epithelial cells. total ev integrin levels, including the quantity of integrins α , αv, and β correlate with tumour stage across a variety of epithelial cancer cells. in particular, integrin α also largely reflects breast and ovarian progenitor cell expression, highlighting the utility of this integrin protein as a potential circulating biomarker of certain primary tumours. other integrins including α , αl, and β are enriched in vesicles derived from leukaemia cells, and may provide a means to distinguish haematopoietic cell-derived evs. summary/conclusion: this study provides preliminary evidence of the value of vesicle-associated integrin proteins in detecting the presence of cancer cells and prediction of tumour stage. differential expression and selective packaging of integrins into evs may contribute to further understanding the development and progression of tumour growth and metastasis across a variety of cancer types. effect of nicotine and menthol on cytochrome p and antioxidant enzymes in rat plasma-derived extracellular vesicles introduction: tobacco products such as e-cigarettes pose potential adverse health effects caused by direct exposure to aerosolized nicotine, flavorants such as menthol, and other particulates. here, we aimed to study the hypothesis that whether nicotine and menthol modulate nicotine-metabolizing cytochrome p a (cyp a ), antioxidant enzymes (aoes), sod and catalase in plasma extracellular vesicles (evs). modulation of these enzymes would eventually lead to nicotine-induced toxicity and hiv- pathogenesis via evs-based cell-cell interactions. methods: we isolated and characterized evs from rat plasma before and after nicotine self-administration (nic) with audiovisual cue (av) and menthol and characterized using ev markers according to the isev guidelines. protein associated with cyp a , sod , and catalase were quantified by western blot. results: we measured size, total protein, and acetylcholine esterase activity of evs and found no significance difference in these characteristics before and after nic. to investigate the effect av, menthol alone or in combination in the absence and presence of nic, first we evaluated the expression of ev markers cd and cd . the results showed menthol and av together increased the levels of cd (p ≤ . ), the marker of small vesicles, in the presence of nic. the nic with menthol and av showed a pattern of increased levels of small vesicle but could not reach to significance. next, we demonstrated that the nic with av increased the level of sod (p ≤ . ), which showed a pattern of increased levels of catalase and cypa , though statistically non-significant. the expression of nicotine receptor did not change under any conditions used. the results showed an increased level of cyp a (p ≤ . ), sod (p ≤ . ), and catalase (p ≤ . ) in plasma evs in the menthol-nic group compared to menthol group only. nic group with a combined av and menthol, showed further increase in the levels of cyp a (p ≤ . ), and catalase (p ≤ . ). further analysis of plasma evs on inflammatory cytokines/chemokines in these groups, and the effect of plasma evs on nicotine-induced toxicity and hiv pathogenesis are underway. summary/conclusion: nicotine administration increased, though not statistically significant, the levels of circulatory evs. moreover, the study provided evidence that nicotine in the presence of menthol, av, and/or menthol+av increased nicotine-metabolizing cyp a in all the groups and aoes in specific groups. funding: we thank the national institute on drug abuse (grant #da , da- ) for supporting our work. introduction: biomarker discovery in breast cancer (bc) is a clinical need for therapeutics and non-invasive diagnostics. tumour exosomes are involved in premetastatic niche formation and drug resistance and represent a source of non-invasive biomarkers. the identification of tumour exosomal biomarkers provides, not only, the possibility to discriminate patient groups also potential targets to control cancer progression that could be exploited to develop innovate bc therapeutic strategies. methods: we have performed a comparative differenti. al proteomic profile of four bc cell lines and their derived-exosomes, representative of the most relevant bc subtypes in clinic to search non-invasive biomarker candidates. then, we have carried on two bioinformatics approaches: ) protein association network analysis interaction (string) and ) pathway inference analysis (hipathia), to characterize the functional profiling for each bc subtype. results: we have found differentially-expressed proteins, in both cells and exosomes, that include indicators of invasion, metastasis, angiogenesis and drug resistance. exosome proteome profile reflects their different bc cell origin suggesting potential indicators of bc subtype. further, bioinformatics analysis reveals a differential role of exosomes in bc signalling pathways in recipient cells, according to their protein cargo and cell origin. summary/conclusion: our results show a set of cells and exosome proteins that highly discriminate bc subtypes and may significantly contribute to further studies for the design of bc biomarker predictor to stratify bc patients and the development of novel therapeutic strategies. funding: a set of potential biomarkers to discriminate breast cancer subtypes. circulatory evs as potential biomarkers of hiv-drug abuse interactions and neurological dysfunction in hiv-infected subjects and alcohol/ tobacco users sunitha kodidela a , kelli gerth a , namita sinha a , asit kumar b , prashant kumar a and santosh kumar a a uthsc, memphis, usa; b university of tennessee health science center, memphis, usa introduction: abuse of alcohol and tobacco can exacerbate hiv pathogenesis and its associated complications. further, the diagnosis of neurocognitive disorders associated with hiv infection and drug abuse using csf or neuroimaging are invasive or expensive methods, respectively. therefore, extracellular vesicles (evs) can serve as reliable non-invasive markers due to their bidirectional transport of cargo from the brain to the systemic circulation. hence, we aimed to study the specific evs proteins, which are altered in both hiv and drug abusers to identify a physiological marker to indicate the immune status and neuronal dysfunction of hiv-positive drug abusers. methods: evs were isolated from plasma of the following subjects: a) healthy b) hiv c) alcohol drinkers d) cigarette smokers e) hiv+alcohol drinkers f) hiv +cigarette smokers. quantitative proteomic profiling of evs was performed by mass spectrometry and potential ev proteins associated with neuronal dysfunction were quantified by westernblot. results: the evs were characterized according to the isev guidelines. a total of proteins were detected in evs of all the study groups. comparison of proteins among all the study groups revealed that hemopexin was significantly altered in hiv+drinkers compared to drinkers and hiv subjects. further, our study is the first to show properdin expression in plasma evs, which was decreased in hiv+smokers and hiv+drinkers compared to hiv patients. though we couldn't identify the few other cns-specific proteins, g-fap and l -cam, associated with neuronal dysfunction in plasma evs by mass spectrometry, we could detect those by westernblot. the protein expression of gfap (p < . ) was significantly enhanced in plasma evs obtained from hiv-positive subjects and drinkers compared to healthy subjects, suggesting enhanced activation of astrocytes in those subjects. the l cam expression was found to be significantly elevated in smokers (p < . ). both gfap and l cam levels were not further elevated in hiv+smokers compared to hiv+nonsubstance users. summary/conclusion: the present findings suggest that hemopexin, and properdin show potential as markers for hiv-drug abuse interactions. further, astrocytic and neuronal-specific markers (gfap and l cam) can be packaged in evs and circulate in plasma, which is further elevated in the presence of hiv infection, alcohol, and/or tobacco and thus may represent as potential biomarkers for neurological dysfunction in those subjects. funding: we thank the national institute on drug abuse (da ) for supporting our work. . electrochemical detection of mirna- - p introduction: micrornas (mirnas) are small, single-stranded, non-coding rna species that regulate gene expression post-transcriptionally, and are transported by extracellular vesicles (evs). they play an essential role in biological processes, such as development, cell proliferation, apoptosis, stress response and tumorigenesis. thus, mirnas are considered relevant biomarkers in health. more particularly, mirna- - p is expressed in neurons after traumatic brain injury, being expectably transported to peripheral fluids by brain evs that cross the blood-brain barrier. the main goal of this work is to develop an electrochemical biosensor for the detection of mirna- - p in serum. methods: overall, the experimental assembly of the biosensor was made in three stages. the first one consisted in the electrodeposition of aunps, the second one in the incubation of anti-mirna - p on the carbon screen-s printed electrodes and the final stage in the incubation of mercaptosuccinic acid for blocking unspecific bindings. the probe was hybridized with the target mirna - p by a consecutive incubation of several standard solutions. each modification was evaluated with cyclic voltammetry (cv), electrochemical impedance spectroscopy (eis) and square wave voltammetry (swv). the electrochemical behaviour of the biosensor was followed in all steps by monitoring the electron transfer features of a standard redox system. the redox probe selected for this purpose was [fe (cn) ] -/[fe(cn) ] -. results: the results indicated that the electrodeposition of gold was more effective for − . v for s and could lead to better signals upon anti-mirna- - p hybridization. summary/conclusion: in general, the experiments showed increasing charged transfer resistance upon the incubation of higher concentrations of mirna- - p. in these experiments, ev concentration is a critical variable that must be carefully controlled to ensure scientific rigour and reproducibility: without controlling for concentration (dose), experimental outcomes will exhibit excess variability that could mask important biological discoveries. in this study, three orthogonal methods are compared for accuracy in ev quantification: microfluidic resistive pulse sensing (mrps) and nanoparticle tracking analysis (nta) were compared to each other and relative to the gold standard method, transmission electron microscopy (tem). the ability of nta to accurately measure particle concentration is shown to depend on the polydispersity of the sample itself. results validate the accuracy of mrps and emphasize the importance of using orthogonal techniques to quantify evs. methods: reference urinary vesicles were prepared and analysed with the three methods and the relative concentration accuracy of nta and mrps were compared as a function of particle size. the hypothesis that nta concentration accuracy was impeded by sample polydispersity was tested using polystyrene bead mixtures having a range of polydispersity. a theoretical argument based on fundamental physics explains the experimental observations. results: tem and mrps measurements of the evs were in excellent agreement and showed a broad, polydisperse particle size distribution with no peak on the measured size range ( nm - nm diameter). nta differed significantly from tem and mrps by reporting a steep decrease in measured concentration below about nm that resulted in a peak in the reported particle size distribution. bead measurements confirmed the hypothesis to be tested: sample polydispersity significantly affects the ability of the nta method to accurately measure concentration, even for particles as large as nm diameter. summary/conclusion: these experiments validate mrps as an accurate method for quantifying evs and highlight the importance of using orthogonal measurement methods in accordance with misev guidelines. clinically relevant synthetic reference materials to standardize concentration measurements of extracellular vesicles: state-of-the-art and future prospects introduction: there is an unmet need to standardize concentration measurements of extracellular vesicles (evs). flow cytometry is the clinically most applicable method, but the currently available reference materials for calibration are insufficient. for example, the refractive index (ri) between standard particles and evs substantially differs, whereas concentration and fluorescence calibration particles are too bright. the goal of this study is to ascertain the most desired properties of reference materials to standardise ev measurements. methods: an online survey was prepared within the meves ii project to measure the desired size, concentration range, optical properties, choice of fluorochromes, and stability of synthetic ev reference materials for flow cytometry (fcm) measurements. besides the desired properties of ev reference particles, also the available instrumentation was assessed in the survey, which was sent to the members of the stakeholder committee of metves ii project and members of the ev flow cytometry working group. results: the most desired size, concentration, and ri range for ev reference particles is nm to nm, e to e /ml, and . - . , respectively. based on mie-theory evaluation of the sensitivity of the available instruments, none of the respondents would be able to detect nm particles with ri = . with their current instruments. regarding fluorescence intensity, the most desired range according to the responses is from molecules of equivalent soluble fluorochromes (mesf) to mesf. considering the sizes of evs and fluorescent labels, the maximal mesf that can be obtained for ev reference particles with nm diameter and high molecular mass fluorescent dyes is in the range of several hundreds. typical antigen densities on evs fall below copies per ev with nm diameter, i.e. mesf values above are probably not physiologically relevant in this size range. summary/conclusion: a part of the desired properties of ev reference materials precludes either their physical feasibility of production or their detection at most currently available fcms, meaning that the intended reference materials will be future-proofed. funding: this work was supported under hlt metves ii project by the european metrology programme for innovation and research (empir). the empir initiative is co-funded by the european union's horizon research and innovation programme and the empir participating states. comparison of production and activity of amniotic fluid stem cell extracellular vesicles from d hollow fibre bioreactor and d culture. culture conditions may affect ev composition and potency. here we compare production, potency, identity and therapeutic potential of evs collected from cells grown in culture dish ( d) versus hfbr ( d). methods: human clonal afsc were derived from patient-consented amniotic fluids. x e hafsc were seeded in d ( cm ), and . x e hafsc on a small kd mwco hfbr (fibercell-c d, cm ) with fibronectin coating; both cultured in chang medium with % of es-fbs, starved for hr and then evs collected. the effect of harvest frequency was tested ( hrs, hr, hrs, wk). d-evs and d-evs were compared by nanosight, potency assay (by wb), identity (by exoview analysis) and therapeutic effect (in vivo in an animal model of kidney disease, alport syndrome). results: d production was~ . x e ev/ml/ hrs while d was~ . x e ev/ml (first four hrs) and . x e ev/ml (two days of hourly harvests). very little difference in ev concentration and very similar size distribution (~ nm) were observed during harvest intervals; possibly indicating either significant ev re-uptake or inhibition of ev secretion dependent upon free ev in the supernatant. d-evs trapped vegf (an in vitro established potency assay) as efficiently as d-evs, and expressed cd , cd , cd , cd , cd and vegfr as d-evs. summary/conclusion: d-evs had comparable properties and bio-activity to d-evs, but the hfbr produced x more evs. hfbr cell culture conditions for hafsc still need optimization, however an available . m cartridge provides a x scale up potential. the hfbr, a cgmp closed system, can produce sufficient numbers of ev to support pre-clinical and clinical applications with at least similar properties to evs produced by conventional d methods. funding: -intramural funding -intramural ev core pilot funding demonstration of high gain mode in combination with imaging flow cytometry for improved ev analysis luminex corporation, seattle, usa introduction: extracellular vesicles (evs) are membrane-derived structures that include exosomes, microvesicles, and apoptotic bodies. in recent years, the importance of evs has become apparent, as they are key mediators of intercellular communication. however, quantifying and characterizing evs in a reproducible and reliable manner is challenging due to their small sizeexosomes range from to nm in diameter. it is well-known that flow cytometers were originally designed to measure and detect cells, and due to the quantitative power flow cytometry offers, there has been a push to quantify and characterize evs using flow cytometric methods. however, these systems have not been designed to measure objects smaller than a cell. methods: here, we describe the use of high gain mode on the amnis® imagestream® imaging flow cytometer to address the challenges of measuring small particles. in this new high gain mode, the charge-coupled device (ccd)-camera is manually adjusted to higher gain settings, increasing the signal obtained from the ev. object thresholds and masking have also been adjusted to better identify and detect small particles. results: preliminary results using murine leukaemia virus-sfgfp reference particles have shown up to a fivefold increase in the number of gfp-positive objects collected in high gain mode, when compared to standard gain on the imagestream system. summary/conclusion: in this study, we demonstrate improved small particle detection, including evs, using this new high gain mode on the imagestream imaging flow cytometer. distance-controlled accelerated catalysed hairpin dna circuit for multiple and sensitive detection of exosomes-associated mirnas introduction: sensitive and simultaneous monitoring of multiplexed exosome-associated rnas is of great value for early cancer diagnosis remains a challenge. methods: here, we report a simple, multiple and sensitive exosomes-associated multiplex mirnas detection method that uses distance-controlled accelerated catalysed hairpin dna circuit (chdc) system without any complex operation or enzymatic amplification. the distance-controlled accelerated chdc can directly enter the plasma exosomes to generate fluorescent signal quantitatively by specifically targeting mirnas without any transfection means. results: we show that distance-controlled accelerated chdc strategy with signal amplification capability could selectively and sensitively identify low level rnas in serum evs, distinguishing patients with early-and late-stage breast cancer from healthy donors and patients with benign breast disease. summary/conclusion: this simple, accurate, sensitive, and cost-effective liquid biopsy by the distance-controlled accelerated chdc method is potent to be developed as a non-invasive breast cancer diagnostic assay for clinical applications. impact of isolation methods on biophysical heterogeneity of single extracellular vesicles university of california los angeles, ca, los angeles, usa introduction: current biophysical analysis of extracellular vesicles (evs) typically encompasses particle density and size distribution determinations using various techniques. however, variabilities in ev isolation methods and the structural complexity of these biological-nanoparticles (sub- nm) necessitate more rigorous nanoscale biophysical characterization of single evs to facilitate more reliable and comparable evbased assays. methods: combining atomic force microscopy (afm), super-resolution optical and conventional particle sizing light scatter and microfluidic techniques, we compared the unique sub-nanometre scale biophysical properties of breast cancer cell-derived ev isolates obtained using different isolation methods. results: afm and dstorm particle size distributions showed coherent unimodal and bimodal particle size populations in centrifugation and immune-affinity isolates respectively. more importantly, afm imaging revealed striking differences in nanoscale morphology, surface undulations, and vesicle-to-non-vesicle ratios among ev isolates from different isolation methods. our findings demonstrate the effectiveness of orthogonal high-resolution biophysical characteristics of single evs, not discernable via particle size distributions and counts alone. summary/conclusion: the identified nanoscale biophysical characteristics of ev isolates represent a strategic and complementary framework to resolve differences in the heterogeneity and purity of evs from introduction: extracellular vesicle (ev) concentrations measured by flow cytometry are incomparable. to improve comparability, the metves ii consortium is developing traceable reference materials and procedures, which require validation by test samples. in previous interlaboratory comparison studies, however, a main source of variation was introduced by pre-analytical variables and measurement artefacts introduced by test samples. to minimize variation introduced by test samples, our aim is to develop off-the-shelf biological test samples containing pre-labelled evs. methods: human urine and plasma were collected from healthy donors. evs were labelled with lactadherin-fitc, isolated by size-exclusion chromatography to remove free dye and minimize swarm detection, and mixed with dimethyl sulphoxide (dmso), exocap or trehalose, frozen in liquid nitrogen and stored at − °c . after thawing, ev concentrations were measured by a calibrated flow cytometer (apogee a -micro). results: compared to the ev concentrations measured in fresh plasma and urine, the concentrations decreased % in plasma (p = . ; mean of the cryopreservation agents) and % in urine (p = . ) after one day of storage. after months of cryopreservation, the concentration of plasma evs decreased % (dmso and exocap) and . % (trehalose) compared to one day of storage, whereas the concentration of urine evs decreased % (exocap) and % (dmso and trehalose). summary/conclusion: we have developed ready-touse, pre-labelled human evs that are stable up to months and dedicated for use in interlaboratory comparison studies. to further increase stability, other cryopreservation agents will be tested. our biological test samples will be key to validate the new reference materials and procedures developed by metves ii in . funding: this project has received funding from the empir program co-financed by the participating states and from the european union's horizon research and innovation program. understanding intracellular fate of ev-delivered content introduction: despite much work performed on evaluating the potential effects of extracellular vesicles (evs), the functional uptake of their cargo is still controversial. this project aimed to demonstrate that ev content (protein and mrna) is protected and can be subsequently transferred with functional activity into recipient cells, while also developing a tool to assess and quantify functional ev uptake. methods: fusion proteins used were mitochondrial localized coxviii-cfp-nanoluc(cox) and nuclear localized h b-rfp-nanoluc(h b). results: hek t cell-derived evs protected cox proteins from proteinase k digestion while demonstrating significantly improved efficiency of uptake when compared to free protein, as measured by bioluminescence that was still detectable in recipient cells hrs post-ev-exposure. to confirm functional uptake, recipient cells exposed to evs containing h b for hrs were imaged and some recipient cells manifested fluorescent red nuclei. to demonstrate the presence of functional mrna within evs, producer cells were transfected for such a duration as not to have detectable levels of protein in the evs while still containing detectable levels of mrna (qpcr) even after rnasea treatment. transfer of these evs to hela cells showed an increase in expression of h b which was blocked by cyclohexamide, confirming translation of the mrna ( . kb). to determine if recycling of ev delivered proteins occurs, recipient hela cells were exposed to evs containing cox for hrs. all extracellular evs were removed and cells were trypsinized ( . % for min) to remove any non-internalized cox protein. hrs later, evs (cd + and cd +) released from cells contained cox suggesting recycling of protein or possibly recycling of entire evs. lastly, an assay was developed to measure functional ev uptake. nanoluc protein was split in two and fused to mturquoise (n ) or mscarlet-i( c). expression of each fragment alone exhibited non-detectable levels of luminescence while expressing both together had a significantly increased signal. delivery of either fragment within an ev to a cell expressing the corresponding fragment worked as confirmation and quantification of ev uptake (hek , u , hela cells). summary/conclusion: this study robustly demonstrates ev delivery of functional mrna and protein to cells, while also establishing a simple assay to quantify and validate functional ev uptake. theoretical model of ev losses due to adsorption on the tube walls. application for immunomagnetic detection of the vesicles introduction: short-term storage of unfrozen samples of vesicles, mainly at °c, overnight or during a couple of days is rather common laboratory practice. however, it was found to lead to significant losses of vesicle concentration supposedly due to adsorption on the walls of the tube. the present work develops a theoretical model intended to describe the vesicle adsorption process. the experimental validation of the model was made using method of immunomagnetic precipitation. methods: the theoretical model considers the "diffusion-limited" case of vesicles storage. the maximal adsorption capacity of the surface of contact between the tube and the solution is given as the number of vesicles in hexagonally packed monolayer. for experiment, the vesicles were purified from ht cell culture supernatant by differential centrifugation, aliquoted and kept at − c. further the aliquots were consequently unfrozen, and placed into the tubes with different surface treatment and kept at + c. the kinetics of vesicles loss was measured by anti cd immunomagnetic capturing followed by cd , epcam and cd staining and flow cytometry. results: the model allows the estimation of the adsorption-associated losses as dependent on initial vesicles concentration, volume of the solution, tube geometry, the storage temperature and duration case of quiet vesicles storage (without mixing) and also accounts an expected effect of active agitation of the solution (ev-beads complexes formation). theoretical calculations were illustrated by analysis of ev at different storage conditions and during reaction of immunomagnetic precipitation of the vesicles. summary/conclusion: it was demonstrated that application of tubes surface treatment allows increasing sensitivity of immunomagnetic precipitation method to x ^ for cd +, x ^ for epcam+ and x ^ for cd + vesicles. introduction: it is now largely accepted that the intestinal microbiota plays a key role in intestinal bowel diseases (ibd). an imbalance in the composition and diversity of the intestinal microbiota (i.e. dysbiosis) of patients has been repeatedly pointed out by several teams. there are also indications that extracellular vesicles produced by bacteria and exosomes produced by epithelial cells might be increased in this family of diseases. methods: in order to differentiate healthy and ibd faecal samples on the basis of their vesicle profiles, we want to develop a means to enumerate rapidly particles in faecal samples, based on interferometric microscopy. the videodrop technology, developed by myriade, relies on the creation of single beam interferences between two signals from the same light path by nanoparticles such as small vesicles. it will permit to compare on large scales the viral load of healthy subjects and ibd patients. results: this fast and easy-to-use device was compared to the nta on several types of eukaryotic and prokaryotic vesicles and our preliminary results are encouraging. introduction: small extracellular vesicles (sevs) produced by mesenchymal stromal cells (msc-sevs) may be useful in cell-free therapies for immunomodulation and tissue regeneration. methods: to characterize msc-sevs produced ex vivo, human bone marrow mscs were cultured in mesencult-acf plus (macfp), an ev-free and animal component-free culture medium for days and spent medium collected to isolate sevs by ultracentrifugation (uc). analyses of sevs were performed by nanoparticle-tracking analysis (nta), western blot (wb), and human umbilical vein endothelial cell (huvec) tube formation assay. results: analysis of fresh uncultured macfp by uc, nta and wb for cd , cd , and cd confirmed the absence of sevs. msc-sevs isolated from spent macfp by uc ranged from - nm in size and were positive for cd , cd , and cd proteins. these sevs could be stored at − °c for > months in solution or lyophilized with minimal loss based on nta and wb analysis. the msc-sevs contained the msc-associated micrornas let a, mir , and mir a as per qpcr analysis. the biological function of ex vivo isolated msc-sevs was assessed using a human umbilical vein endothelial cell (huvec) tube formation assay. huvecs treated with msc-sevs generated tubes as early as h after seeding, which were not observed in control huvec cultures until h. moreover, the number of branch points present in such tube structures was >fourfold higher in huvec cultures (n = ) supplemented with msc-sevs versus control, with the former lasting > h and the latter lasting < h in culture. direct comparison of the performance of macfp medium to media containing non-depleted or ev-depleted foetal bovine serum demonstrated that only mscs cultured in macfp (n = ) were able to expand robustly with a doubling time of . , . and . days in these media, respectively. lastly, methods for isolating sevs using newly developed easysep-ev™ magnetic separation kits and size exclusion columns will be presented. summary/conclusion: taken together, these data demonstrate that msc-sevs can be produced in high yield in macfp medium and that these possess similar physical, phenotypic and functional characteristics as sevs in vivo. funding: this work was privately funded by stemcell technologies inc. introduction: extracellular vesicles (evs) are heterogeneous group of small vesicular structures released by different types of cells, including stem cells (scs). as recent studies demonstrate that they may enclose bioactive content and transfer it into the target cells, growing interest is placed on the utilization of evs in the field of biomedical research. however, there is still lack of standardized methods of evs characterization. as an example, typical flow cytometry-based protocols, commonly used for cells phenotyping, may be inadequate for the characterization of evs as particles with size close to the detection limit of conventional cytometers. thus, the aim of this study was to optimize and compare the use of different flow cytometry platforms for the multiparameter analysis of evs isolated from different types of scs populations. methods: ev samples were obtained by ultracentrifugation of conditioned media collected from selected scs types, including human induced pluripotent scs (ips) and mesenchymal scs (mscs). next, several high resolution flow cytometry systems: cytoflex, apogee (a and a micro-plus) and image stream mk ii were employed to compare their sensitivity and resolution, as well as influence of "swarm" effect. furthermore, we examined evs phenotype, including expression of tetraspanins and other surface markers. results: our results have revealed that tested flow cytometry systems may be utilized for the phenotypic characterization of evs secreted by scs populations. however, the conventional staining and gating strategy protocols have to be thoroughly optimized. additionally, depending on a type of tested cytometer, we have demonstrated the difference in a "swarm" effect and its influence on obtained results regarding evs phenotype. finally, imaging flow cytometry platform was also employed to visualize evs on the single particle level. summary/conclusion: in conclusion, we have demonstrated that tested high-resolution flow cytometry platforms are convenient methods for the multiparameter characterization of evs produced by different types of scs populations. however, careful selection of particular measurement parameters should be performed depending on a type of employed system. funding: this study was funded by ncbr grant strategmed iii (strategmed / / / ncbr/ ) to ezs. evaluation of atcc's exosomes from cell culture supernatant as reference standards in research and development. introduction: exosomes are subcellular particles - nm in size released from cells through a fusion of multicellular bodies with the plasma membrane. exosomes are stable carriers of cell-free cargo in the form of dna, rna, and proteins, thereby making them an attractive candidate for diagnostic and therapeutic applications. however, isolating a consistent population of exosomes can be challenging and there is an unmet need for highly characterized exosomes for use as reference standards in extracellular vesicle research (ev). methods: exosomes were isolated from cell culture supernatants of different atcc cell lines including stem cells and cancer cell lines representing the most prevalent cancer types -prostate, colorectal, breast, lung, cervical and glioblastoma, using tangential flow filtration (tff). these exosomes underwent sterility and mycoplasma tests as a part of their quality control. the morphology and size distribution of these exosomes were evaluated through multiple strategies including nanoparticle tracking analysis (nta), asymmetrical flow field-flow fractionation (af ), cryo-electron microscopy (cryo-em) and spectra dynetm particle analyser. exosome surface markers were also analysed through multiple strategies such as electro chemiluminescent elisa, flow cytometry and western blotting. also, stem cell exosomes and cancer exosomes were further evaluated for functionality through in vitro functional assays including migration assay, angiogenesis and anchorage independent growth assay. results: our optimized tff method resulted in high yields of > × exosomes/ml and average protein equivalent of more than mg/ml. more than % of the exosomes population had an average size distribution of - nm and median size of nm confirmed through a number of different size distribution instruments. although cell line dependent, we were able to obtain similar expression levels of different cell surface markers including tetraspanins (cd , cd , cd ) when evaluated through different methods. our functional data demonstrated stem cell exosomes were functionally active in promoting cell migration and tubule formation. additionally, cancer cell exosomes were found to promote a malignant phenotype in an anchorage independent growth assay. summary/conclusion: collectively, we demonstrated our ability to reproducibly manufacture production-scale batches of exosomes from multiple different cell types. our purified exosomes are of high yield, meet well-established quality control specifications, and are robust in maintaining size distribution, surface marker expression, and functionality in vitro. therefore, they can serve as ideal reference materials that can support different ev-based research applications. exo-cise: extracellular vesicles enriched from plasma post-exercise promotes myogenesis and neurogenesis bianca paris a , yaomeng liu a , vicente pagalday-vergara a , julie davies b , priya samuel a , ayman abu seer a , johnny collett a , laura gathercole a , ken howells a , karl j. morten b , zhidao xia a , daniel anthony b , david r f. carter a , helen dawes a and ryan c. pink a a oxford brookes university, oxford, uk; b university of oxford, oxford, uk introduction: physical activity brings about a widespread physiological response and elicits the beneficial adaptation of several tissues and organs. furthermore, regular participation in physical activity reduces the risk of developing major non-communicable diseases such as cardiovascular disease, diabetes, cancer, osteoporosis, and dementia. two important processes known to occur following physical activity are myogenesis and neurogenesis; both of which involve the activation and proliferation of specialised tissue-resident stem cells. the molecular mechanisms regulating these processes following exercise are poorly understood to date. here, we investigated the contribution of extracellular vesicles, which are released into the circulation after exercise, to benefit adult myogenesis and neurogenesis. methods: small extracellular vesicles were enriched from the blood of healthy participants before and following maximum and moderate intensity exercise. differentiation and proliferation using a range of methods was measured following vesicle treatment onto primary myoblasts and neuronal primary exvivo stem cells. activation of key cellular pathways were measured. results: we show significant proliferation and differentiation changes of both stem cell types. this is independent of extraction method, extracellular vesicle depleted fractions and is interestingly conserved across mammalian species. remarkably, we see an age-related effect. summary/conclusion: this advocates that short single bouts of exercise may promote myogenesis and neurogenesis via systemic signalling of extracellular vesicles which opens an interesting field in endogenous ev therapies. show promise as a cell-based therapy for retinal degeneration. while clinical trials are ongoing, the potential of extracellular vesicles (evs) as biomarkers for monitoring eye health and disease is not well studied. this study characterized the ev surface profile and cargo of hipsc-rpe to offer a baseline assessment in normal and disease conditions. moreover, we evaluated the importance of pnpla , a gene involved in membrane integrity and when mutated causes retinal degeneration, in ev biogenesis and secretion. methods: evs were isolated from serum-free culture medium of hips-rpe and identified with nanoparticle tracking analysis, transmission electron microscopy, and immunoblot analysis of exosomal markers, including alix, tsg , and cd . surface marker detection and proteomic profiling were completed using an ev surface marker kit and mass spectrometry, respectively. small interfering rna targeting pnpla was used to knockdown the expression in hipsc-rpe and evs were characterized. results: nanoparticle tracking analysis confirmed the presence of both microvesicles (> nm) and exosomes (< nm) by size distribution and the concentration of evs ( x particles/ml) from rpe. tem displayed typical morphological characteristics of evs. the presence of known ev markers, alix, tsg , and cd was confirmed via immunoblot and flow cytometry. surveillance of ev surface markers revealed enrichment of epithelial markers (cd ) and stem cell markers (cd / ) that depict donor cell origin and functional proteins including integrin-binding (cd ) and tgf-beta receptors (cd ). in addition, proteomic analysis revealed regulators of inflammation and rpe function, including hemopexin, clusterin, complement factor i, and pigment epithelium-derived factor. furthermore, reduction in pnpla expression reduced vesicle secretion and vesicle size compared to non-targeting controls. introduction: vascular endothelial growth factor (vegf) is a potent angiogenic factor and was first described as an essential growth factor for vascular endothelial cells. vegf plays a role in normal physiological functions such as bone formation, haematopoiesis, wound healing, and development. mesenchymal stem cell (msc) was found to secretes potential growth factors such as vegf when cultured in vitro. however there are some beliefs that foetal bovine serum (fbs) which usually used as serum in cell culture content vegf. methods: msc seeded in in -well plate in with concentration of , cell/well. cells were incubated for hours and fasted for another hours using only dmem. cells were treated with complete medium consist of dmem and % fbs. culture medium were collected after , , and hours after treatment. cell were culture in ºc dan % co . vegf concentration was detected using elisa technique. results: vegf concentration was not found in fbs which do not contact with msc. an increasing of vegf concentration in time-dependent manner was shown when culture medium was used in msc cell culture in normoxic condition. the result of vegf concentration when culture , , and hours were . pg/ml, . pg/ml, and . pg/ml, respectively. the mechanism of msc release growth factor is still under investigated. however, the classic growth factors and cytokines serves paracrine control molecules which were important in regenerative medicine. vegf was found to be an important molecules in angiogenesis process and determine the fate of cells. summary/conclusion: msc secreted vegf and concentration increased in time-dependent manner. isolation and characterization of exosomes from canine stem cells introduction: unlike induced disease models using laboratory animals, naturally occurring disease models display pathophysiologic attributes that are more similar to human diseases. unfortunately these models are underutilized in translational regenerative medicine research. this is partly due to the slow development of species-specific experimental therapeutics to investigate comparative efficacy. thus, we set out to isolate and characterize exosomes from canine adipose-derived mesenchymal stem cells (cad-msc) to use as a comparative therapeutic in dogs. to accomplish this, we optimized an isolation and purification strategy and characterized their molecular properties. methods: exosomes were isolated by sequential centrifugation and subsequent ultrafiltration. the proteome was characterized by tandem mass tag (tmt) mass spectrometry and the mirna cargo was identified using a canine specific pcr array with subsequent target and enrichment analysis using targetscan and the panther platform, respectively. also, nanoparticle tracking analysis and transmission electron microscopy were used to determine exosome size and structure. to investigate bioactivity, we measured the ability of exosomes to inhibit collagen production in an in vitro model of fibrosis. results: exosomes were purified by ultrafiltration using a kda cut-off. proteomic analysis by tmt mass spectrometry identified unique proteins. % of the exocarta top were identified from this list. additionally, we identified the mirna cargo within exosomes and found highly expressed mirnas. enrichment analysis identified multiple pathways of probable regulation including angiogenesis (fold enrichment = . ; p < . ) and transforming growth factor-beta (tgfb) signalling (fold enrichment = . ; p < . ). exosome size was quantified to be . ± . nm with a modal average of nm. lastly, in the presence of exosomes, tgfb stimulated fibroblasts deposited . % less collagen than vehicle controls (p = . ). summary/conclusion: in summary, cad-mscs exosomes display structural and functional features comparable to stem cell derived exosomes from other species. use of these exosomes in naturally occurring disease canine models may provide superior predictive value for human clinical trials. funding: support provided by the ccah, school of veterinary medicine, uc davis. mesenchymal stem cells-derived exosomes promote in vitro the progression of triple negative breast cancer cells introduction: mesenchymal stem cells (mscs) are multipotent stromal cells and have been described as key regulators of different aspects of tumour physiology. in tumour pathogenesis, mscs can integrate the tumour microenvironment after recruitment and are able to interact with cancer cells to promote tumour modifications by affecting epithelial-tomesenchymal transition (emt). it was revealed that exosomes derived from mscs are critical players in the tumour niche. exosomes are a novel way of cellto-cell communication and play crucial roles in the majority of pathways that contribute and affect response to therapy, cell-adhesion molecules and the progression of tumour cells. because of the known importance of this communication we decided to investigate the implication of mscs with triple negative breast cancer (tnbc) cell lines as well as exosomal profiles between the experimental conditions. methods: the interactions of mscs with triple negative breast cancer cell lines (mda-mb- and hs t) was performed by coculturing mscs (or tnbc cell lines) with exosomes derived from tnbc cell lines (or mscs). physical characterization of isolated exosomes was performed followed by their molecular investigations. cell proliferation was detected by mtt assay and migration was analysed by wound healing assay using d cultures. moreover, we also used d culture to assess the exosomes uptake and to observe their capability of internalization into a d structure. the alterations in expression level of some transcripts (mrnas and mirnas) and protein profile were investigated by qrt-pcr, western blot and immunofluorescence staining. results: we found that mscs-derived exosomes are actively incorporated by triple negative breast cancer cell lines ( d culture). in coculture, in tnbc cells the expression level of mesenchymal markers and emt markers (e-cadherin, vimentin) at mrna and at protein levels, as well as mirna-derived exosomes targeting mesenchymal genes were significantly affected. using bioinformatics tools, we highlighted the important biological processes which were activated by promoting tumour modifications. in addition, using d culture we provided a comprehensive understanding regarding exosomes internalization in d structures, which closely mimics in vivo conditions, compared to d culture. summary/conclusion: in this work, we focus on the investigation of mscs-derived exosomes in order to highlight their implication in several biological processes, including tumour proliferation and progression of triple negative breast cancer cells. all these alterations affect the response to therapy and should be considered for developing efficient therapeutic strategies. natural killer cell-derived extracellular vesicles have a potent anti-leukaemic effect and selectively target the cancer stem cell subpopulation introduction: natural killer (nk) cells of the immune system recognize and kill tumour cells. extracellular vesicles (evs) secreted from nk cells are capable of killing tumour cells independent of the cell to cell contact required for nk cell activation. cancer is a leading cause of death, primarily due to metastasis and recurrence. cancer stem cells (csc) within tumours are resistant to chemotherapy and immune attack, and cause metastasis and relapse. identification of the cancer types killed by nk evs is limited, and the effect of nk evs on cscs has not been described. here we determine whether nk-derived evs kill a myeloid leukaemia cell line and its csc subpopulation. methods: nk evs were isolated from our nk cell line, nk . , derived from normal human lymphocytes. nk . evs were characterized by immunoblotting, proteomics, and next generation rna sequencing. human k leukaemia cells were treated with nk . evs in vitro and analysed for proliferation and markers of cell death. results: nk . evs contain ev-associated proteins alix, cd , hsp , and tsg , nk effector molecules perforin, granzymes a and b, granulysin and nklam/ rnf b, an e ubiquitin ligase required for maximal nk cytotoxicity, and tumour suppressor mir- . nk . ev treatment of k significantly decreased its expression of proliferation markers cd and ki , and increased the frequency of apoptotic and necrotic cells, paralleled by elevated levels of active caspases − and − . non-tumorigenic cells were unaffected by nk ev treatment. most notably, nk . ev treatment significantly reduced the frequency of k cells highly expressing aldh, a csc marker. summary/conclusion: nk . -derived evs have a robust anti-tumour effect on k myeloid leukaemia cells and selectively target the csc population, suggesting they may circumvent the evasion and resistance mechanisms used by cscs. nk . evs therefore have introduction: due to their potential as a key bioactive agent in regenerative medicine applications, mscderived extracellular vesicles (msc-evs) are increasingly being investigated as a clinical therapy. manufacturing that generates enough evs for product development and clinical doses is currently a limitation in the field and clearly a scalable manufacturing solution will be necessary for successful translation. moreover, a complementary approach that increases the ev productivity, i.e. the number of evs produced per cell, could further help to accelerate the development of msc-evs as a therapy. methods: we developed a process that leverages a series of new cell culture reagents to couple to our established cell-media system for scalable manufacturing of msc-evs. briefly, human bone marrow-or umbilical cord-derived mscs were rapidly expanded under xeno-free conditions (i.e. > x expansion within days). cultures were then switched to our proprietary ev collection medium and evs were harvested for up to three additional days. at the end of culture, the evs in the conditioned media were concentrated using a tangential flow filtration (tff) system. to increase the productivity of mscs, two medium supplements were developed that increased ev yield by either increasing the number of evs generated per cell in a shortened culture process or increasing the number of collected evs by lengthening the ev collection culture period. results: this scalable msc-ev manufacturing method was implemented in both d flask and d bioreactor culture and generated over , particles per cell in d and over , particles per cell in d. with the addition of a medium supplement to increase evs produced per cell, the ev productivity was increased > x after hrs. alternatively, ev productivity was also increased > x by addition of the medium supplement that extended ev collection culture period. summary/conclusion: msc-ev success in clinical translation will be reliant on a manufacturing method that can scalably and reliably generate large amounts of evs. these results present one such solution. furthermore, increasing ev productivity, for instance by medium supplements that increase evs per cell or lengthen culture times could further address the limitation of generating the evs required for development and translation of clinical therapies. simplifying scalable msc ev production in a microcarrier-based bioreactor system divya patel, josephine lembong, katrina adlerz, jon rowley and taby ahsan roosterbio inc, frederick, usa introduction: the growpt ing numbers of msc-ev clinical applications drives the need for a scalable msc-ev production platform. while most msc-evs are generated while cells are attached to tissue culture plastic, such d cultures cannot be scaled up to meet the yields necessary for commercialization of ev-based therapeutics. we have shown that d bioreactors can be used to generate msc-evs and that paradigm can be scaled directly in terms of yield from the to l scales. the technical expertise of seeding cells onto microcarriers for expansion in bioreactors, however, requires technical expertise not available to all those in the ev field. therefore, our goal here is to simplify and expedite the ev collection process in bioreactors by cryopreserving cells on microcarriers, such that end users can merely thaw and then collect msc-evs. methods: mscs were expanded in d and then seeded on three different microcarriers and cultured in a bioreactor for days. when confluent, cells on microcarriers were cryopreserved. to evaluate the microcarriers and the cryopreservation protocol, the cells-microcarriers were thawed, cultured in a bioreactor in growth media for hours, then in ev collection media for additional days. cell recovery and ev production upon thaw was evaluated and compared to ev collection from fresh, non-cryopreserved cells. results: total cell counts hrs post thaw were comparable to those before cryopreservation and to fresh samples prior to ev collection. following -day ev collection, concentration of particles collected from cryopreserved cells on microcarriers were similar to those collected from the fresh cells ( e particles/ml). this process was validated for two different microcarriers using two separate cryopreservation solutions. summary/conclusion: our results show that cryopreserved hmscs on microcarriers can support ev collection in a d bioreactor process with a particle yield that is comparable to those collected from fresh cells. this cryopreserved product can simplify ev production, reducing cost and time by removing process steps associated with the hmsc expansion, with in a paradigm suitable for scale-up. the whitening, anti-wrinkle, and wound-healing effects of extracellular vesicles from orbicularis oculi muscle-derived stem cells. introduction: skeletal muscle-derived stem cells possess potent therapeutic activities in the treatment of muscle-related disorders. in our study, we tried to isolate and characterize orbicularis oculi muscle (orm)-derived stem cells (orm-scs) from the discarded human tissues which were obtained from the ocular surgery-subjected patients. we also prepared the natural extracellular vesicles (evs) from the cultured orm-scs and assessed the their therapeutic actitities including the skin whitening, anti-wrinkle, and wound healing effects. methods: we isolated the orm-scs from the patients subjected to ocular surgery and characterized the orm-scs by analysing cell morphology, proliferation, expression levels of the cell surface and stemness-associated markers, and tri-lineage differentiation and colony-forming capacities, confirming the stemness properties of the orm-scs. then, we prepared the natural evs from the orm-scs via the centrifugation and filtration of the media supernatants and their therapeutic activity was investigated. results: the isolated orm-scs showed spindle-like morphology and positive expression of cd , cd , and cd , but they were negative in expression of cd and cd . the orm-scs showed the capacity of osteogenic, adipogenic, and chondrogenic differentiations. the evs from orm-scs (orm-sc-evs) possessed the apparent inhibitory effect on the melanin synthesis in b f cells by blocking the tyrosinase activity, although orm-sc-evs treatment did not dramatically change the expression level of melanogenesisrelated genes, such as microphthalmia-associated transcription factors (mitf), tyrosinase (tyr), tyrosinaserelated protein (tyrp- ), and tyrp- . in addition, we confirmed that orm-sc-evs could stimulate skin cell migration and increase the expression level of antiwrinkle related genes and wound-healing properties. summary/conclusion: this study revealed the stem cell property of orm-scs and the whitening, antiwrinkle, and wound healing effects of orm-sc-evs, suggesting that orm-scs and orm-sc-evs can be successfully used for stem cell-based ev therapy and cosmetics, by regulation the melanogenesis, wrinkle, and wound. funding: this work was supported by grants from the national research foundation (nrf) funded by the korean government ( m a h ). use of stem cell extracellular vesicles as a holistic approach towards cns repair introduction: neurological diseases and disorders are leading causes of death and disability worldwide. many of these pathologies are associated with high levels of neuroinflammation and irreparable tissue damage. we have previously shown that extracellular vesicles (evs) from infected cells contain viral by products (noncoding rnas and proteins) and that these evs can exert deleterious effects on recipient cells - . therefore, in the context of neurotrophic viruses evs may contribute to or perpetuate processes relating to neuroinflammation and neurodegeneration. due to their multipotent properties, stem cells have broad applications for tissue repair; additionally, stem cells have been shown to possess both immunomodulatory and neuroprotective properties. in recent years it has been well-established that stem cell evs play a critical role in the functionality associated with stem cells. the diverse biological cargo contained within these vesicles are proposed to mediate their effects and, to date, the reparative and regenerative effects of stem cell evs have been demonstrated in a wide range of cell types. while a high potential for their therapeutic use exists, there is a gap of knowledge surrounding their characterization, mechanisms of action, and how they may regulate cells of the central nervous system (cns). methods: we have isolated and recovered high yields of evs from large scale cultures of both induced pluripotent stem cells (ipscs) and mesenchymal stem cells (mscs) using tangential flow filtration. our ev characterization includes both phenotypic (size, tetraspanin expression) and biochemical assays. ev functionality has also been assessed in vitro utilizing several cellbased assays related to cellular viability, migration, angiogenesis, and immunomodulation in both healthy and damaged recipient cells with relevance to the cns. results: our data suggests that evs from different sources of stem cells display unique phenotypes, exhibit differential association with various cytokines, proteins, and long non-coding rnas, and have the ability to significantly enhance processes that are critical for cellular repair . lastly, utilizing an ipsc-derived neurosphere model, we have observed a robust uptake of stem cell evs and have found that these evs are able to effectively penetrate these d structures. summary/conclusion: collectively, these results highlight the "holistic" properties of stem cell evs by demonstrating their ability to partially reverse or reduce damage in various cell types. funding: this work was supported by national institutes of health (nih) grants ai , ai , ai - , ai , and ns to fk and r ca and r ar to lal. the effect of cell culture media on extracellular vesicle secretion from mesenchymal stem cells and human pluripotent stem cell-derived neurons introduction: cell culture media and its supplements are known to affect the secretion and isolation of extracellular vesicles (evs) from cell cultures. identification of these effects is crucial especially when planning to use evs as therapeutic agents. here, we investigated the effect of cell culture media on ev yield from human mesenchymal stem cells (mscs) and human pluripotent stem cell (hpsc)derived neurons. methods: evs were collected from cell-conditioned media (ccm) and no cell control (ncc) media using size-exclusion chromatography (sec). mscs were cultured in dmem/f :neurobasal medium or in opti-mem reduced serum medium, both supplemented with exosome-depleted foetal bovine serum (fbs). the ev yield from hpsc-derived neurons was compared at two maturation time points (day and ), in dmem/f :neurobasal or in opti-mem, with and without -hour kcl stimulation. sec fractions were analysed by nanoparticle tracking analysis (nta), protein concentration assay and blinded transmission electron microscopy (tem). results: ccm samples had a clear peak of evs in sec fractions - , which was not detected with ncc. interestingly, a second population of evs eluted in sec fractions - in both ccm and ncc, indicating presence of evs in exosome-depleted fbs. moreover, this second population differed largely between used media batches. culture medium had no significant effect on msc ev yield (dmem: . e+ particles/ ml, opti-mem: . e+ particles/ml). with neuronal cultures, no significant differences in ev yield were found between culture media or cell maturation time points. in contrast to earlier findings, -hour stimulation of neurons by kcl resulted in significantly smaller ev yield compared to non-stimulated controls (stimulated: . e+ particles/ml, non-stimulated: . e+ particles/ml, p < . ). summary/conclusion: our results indicate that exosome depleted-media are not entirely devoid of vesicles, which can cause bias in downstream analyses. however, sec is a good method to separate cellsecreted evs from the contaminating medium-derived evs. culture medium did not affect the number of evs secreted by mscs or neurons; instead, we observed larger differences between media batches. this data emphasizes the importance of analysing the ncc as negative control in all cell culture experiments. mouse mesoangioblast stem cell extracellular vesicles are able to influence macrophage cell activity maria magdalena barreca a and fabiana geraci b a dept stebicef university of palermo, palermo, italy, palermo, italy; b dept stebicef, university of palermo, italy, palermo, italy introduction: it is largely demonstrated that stem cells release extracellular vesicles (evs) that are able to modify target cell behaviour. interestingly, there is a bidirectional signalling exchange between stem cell evs and damaged cells. moreover, it is well known that macrophages, could also play a role in wound repair and tissue regeneration. it was also demonstrated that stem cell evs are involved in immune cell regulation. for this reason, today takes hold the idea that evs could replace stem cells in regenerative medicine. the aim of our work was to evaluate if evs released by mouse mesoangioblast stem cells (a ) could have a role in immune cell regulation. specifically, we have investigated the possible a ev effect on murine macrophages (raw . ) in terms of cell proliferation, migration and phagocytic ability, and cytokines/chemokine release. methods: a evs were collected from conditioned milieu by ultracentrifugation. raw . cell proliferation with or without a evs was evaluated via cfse assay. scratch test was performed to assay their migration ability. to study raw . cell phagocytosis they were treated with μm beads. finally, cytokine array was used to monitor their secretion after ev treatment. results: we have found that a evs inhibited macrophage proliferation as proved by a proliferation index significantly reduced after ev treatment. simultaneously, we have noticed that evs increases raw . migration ability. furthermore, a evs are able to increase macrophage phagocytic activity. as it is known that hsp is involved in for macrophagic activity increase and a evs express hsp on their surface, we performed phagocytosis assays assay by blocking the protein or its receptor tlr , tlr and cd . our data demonstrated that a evs increase phagocytosis through hsp and its receptors. we have also proved that a evs modify the expression pattern of cytokines/chemokines released in the extracellular milieu by raw . cells. in particular, we observed an increase in anti inflammatory cytokines, and a decrease in some inflammatory ones, suggesting that evs could polarize macrophages towards an anti inflammatory m phenotype. summary/conclusion: in conclusions, our data show that a evs influence macrophage activity and additional studies could provide a new insight into understanding the underlying potential of evs in tissue regeneration. and ) . in a healthy kidney, the polycystins localize to renal cilia. mutations that abrogate ciliary localization of pkd (yet preserve its channel function) also cause cysts. besides cilia, pkd is also found in other subcellular locations including extracellular vesicles (evs) of human urine. how dysfunction of pkd trafficking and localization leads to the kidney pathology remains unknown. pkd is evolutionarily conserved across all members of eumetazoa. in c. elegans, pkd- is exclusively expressed in ciliated male-specific neurons, where it is trafficked to cilia and evs. gfp-tagged pkd- -containing evs play a signalling role in inter-organismal communication between animals. conservation of polycystin- cellular localization between worm and human suggests that their network of molecular interactions may also be conserved. we propose that pkd- plays distinct roles in cilia versus ciliary evs. methods: to understand the role of evs in c. elegans inter-organismal signalling, we aim to identify the pkd- -associated ev proteome, transcriptome, and metabolome. we established a pipeline for fluorescent labelling and tracking specific ev cargoes in a living animal using super-resolution microscopy. we used fluorescence of the pkd- carrying evs to optimize biochemical procedures for their enrichment. results: our initial analysis revealed two populations of pkd- -carrying evs that differ in their densities: . - . versus . g/ml. we are currently characterizing these two distinct populations using transmission electron microscopy and refining our enrichment procedure for protein identification by mass spectrometry, sequencing of their rna cargoes and metabolome analysis. summary/conclusion: what function human pkd plays within the cilia and within the urinary evs is not well understood. identification of molecular mediators of c. elegans pkd- ev signalling will inform on the interactome of human pkd and its function in cilia versus evs. introduction: ectosomes play roles in many physiological and pathophysiological processes, and their precise is dependent on molecular cargo and parent cell type. a single cell can release distinct subpopulations of evs enriched with different molecular cargo, which adds complexity to elucidating cargo sorting and biogenesis mechanisms. in the nematode c. elegans, ectosomes bud from sensory neuron cilia and are released into the environment to modulate animal behaviour. methods: c. elegans is genetically tractable and optically transparent, allowing for live imaging of fluorescently tagged ev cargo. we express all tagged cargo at endogenous levels, adding physiological relevancy. results: we discovered that the calcium homoeostasis modulator ion channel clhm- localizes to cilia of ev-releasing neurons and observed gfp-tagged clhm- in ciliary evs. using super resolution microscopy, we imaged evs released from animals coexpressing tdtomato-tagged clhm- and gfp-tagged pkd- (another vesicle cargo) in the same neurons. while the two proteins colocalize in the cilia, clhm- ::tdtomato and pkd- ::gfp rarely colocalize in evs. this indicates that separate subpopulations of evs are being released from the same neurons. to determine how the clhm- subpopulation is formed, we are investigating candidate genes. anoh- , a homolog of the ca + scramblase tmem f, localizes to neuron cilia and induces phosphatidylserine exposure on the outer membrane leaflet. in anoh- mutants, the number of clhm- ::gfp evs released is significantly decreased but the number of pkd- ::gfp evs does not significantly change. in addition, i am using facs to isolate clhm- and pkd- containing evs and analysing the respective proteomes with lc-ms/ms. summary/conclusion: we are elucidating mechanisms that give rise to distinct subpopulations of ciliary evs in c. elegans and defining cargoes being enriched in these ev subpopulations to gain insight into ev cargo sorting and biogenesis mechanisms in ciliated neurons. ceramide accumulation induces exosome secretion through lysosomal protein laptm b kohei yuyama, hui sun and yasuyuki igarashi hokkaido university, sapporo, japan introduction: exosomes, a type of extracellular vesicles originated from multivesicular bodies (mvb), are important carriers of cellular molecules and have critical roles in intracellular communication in both health and disease. ceramides (cer) are implicated in biogenesis of exosome, however the molecular machinery that mediates exosome secretion remains obscure. lysosome-associated protein transmembrane- b (laptm b) is a lysosome/late endosome-resident transmembrane protein, which has been reported to bind cer. we demonstrate here that laptm b is involved in the exosome secretion, which are induced by exogenous cer treatment or lysosomal ceramidase inhibition in cultured neuronal cells. methods: neuroblastoma sh-sy y cells were treated with cer (porcine brain-derived cer or synthetic d : /c : ~c : cer) for h. exosomes were isolated from the culture supernatants by sequential centrifugation and their amounts were measured using ps capture exosome elisa kit. to analyse mvb transport, mvb and recycling endosomes are visualized with gfp-cd and rab immunostaining, respectively. results: we found that exogenous treatment of cer, especially those with c and c fatty acids, resulted in a marked increase in exosome secretion. in addition, lysosomal cer accumulation induced by acid ceramidase inhibition also accelerated exosome production. knockdown of laptm b significantly prevented the ceramide-dependent exosome release. in addition, we showed that these cer loading promoted colocalization of cd -positive mvb with rab -positive recycling endosomes, further demonstrated that laptm b knockdown cancelled the cer-dependent increase of the colocalization. summary/conclusion: these data suggest that lysosomal cer binds to laptm b and promote the transport of mvb to plasma membrane, resulting in an increase of exosome secretion in neuronal cells. chloroquine-mediated lysosomal inhibition alters composition and function of cancer-derived extracellular vesicles jing xu a , kevin yang a , shane colborne a , elham hosseini-beheshti b , gregg morin a , emma guns b and sharon m. gorski a a bc cancer, vancouver, canada; b the vancouver prostate centre, vancouver, canada introduction: small extracellular vesicles (sev) are signalling entities released by many types of eukaryotic cells. sev are of special interest in cancer due to their reported roles in modulating the cancer microenvironment and facilitating cancer cell invasion. macroautophagy (hereafter autophagy) is a catabolic process well-known for the recycling of cytosolic cargos through lysosome-mediated degradation. in this study, we profiled the changes in sev content and function under lysosome inhibition and investigated the involvement of autophagy machinery in sev content. methods: chloroquine (cq) was used to inhibit lysosomal degradation and autophagy turnover in triplenegative breast cancer (tnbc) cell lines. sev were collected via precipitation after pre-clearing and concentration of conditioned media. western blotting, nanosight and transmission electron microscopy were used to profile sev. quantitative mass spectrometry was used to characterize cq-induced changes in the sev proteome. antibody-conjugated magnetic beads were used in immunoprecipitation of sev. results: cq treatment did not substantially alter the physical properties of tnbc-derived sev. however, cq treatment altered the sev proteome and growth effects of sev on normal and endothelial recipient cells. cq treatment induced co-localization of mammalian atg proteins with endolysosomal markers in the cytoplasm, which coincided with an enrichment of atg s and their adaptor proteins in sev. cq-induced enrichment of atg s in sev required lipidation, and occured preferentially in one subset of sev. summary/conclusion: our study reveals changes in the content and function of cancer cell-derived sev in response to perturbation of intracellular trafficking pathways, demonstrates the flexibility and heterogeneity of sev composition, and has implications for cq efficacy in therapeutic settings. introduction: introduction: argonaute (ago ) is the essential component of the rna-induced silencing complex (risc) that binds mirnas and promotes mrna degradation. extracellular vesicle (ev)-carried mirnas have been shown to influence gene expression and functional phenotypes in recipient cells. many investigators have found ago in evs and it is postulated that ago is a major transporter of mirnas into small evs (sevs), such as exosomes. others have reported extracellular ago that is non-vesicular. we set out to evaluate the effect of growth factor signalling and serum contamination on the detection of ago in sevs. methods: methods: wildtype kras colorectal cancer cells, dks , were conditioned with different culture media (serum-free dmem, dmem supplemented with ev-depleted fbs, and opti-mem). evs were purified from conditioned media by cushion-density gradient ultracentrifugation. western blot analysis of dks total cell lysates, large evs and density gradient fractions was performed, probing for ago and ev marker proteins. the size and concentration of the evs were determined by particle metrix analysis. results: results: in all conditions, we found the highest abundance of sevs in fractions and , as assessed by western blot analysis. ago was detected in the same fractions as sevs in both the serum-free dmem and opti-mem conditions, although the levels of ago was higher in the serum-free dmem fractions compared to that of opti-mem. in contrast, ago was present in both vesicular and non-vesicular fractions in the dmem supplemented with ev-depleted fbs condition. no significant differences were observed in the size and number of evs collected in the three conditioning methods. summary/conclusion: summary/conclusion: the presence or absence of ago in evs has been controversial. multiple factors may affect the ability to detect vesicular ago , including serum and growth factors in the conditioned media that may provide sources of extravesicular ago and also regulate the trafficking of ago into vesicles. introduction: cancer-associated glycosphingolipids have been utilized as tumour markers and targets of cancer therapy. we have investigated roles of gangliosides in cancers, and clarified that cancerassociated gangliosides enhance malignant properties of cells by forming complexes with membrane molecules in lipid rafts. in this study, we analysed contents of gangliosides and membrane molecules on extracellular vesicles (ecvs) secreted from melanoma cell lines. methods: melanoma cell lines with various ganglioside patterns were used for isolation of ecvs. gangliosidemodified melanomas with genetic engineering were also used. genetic modification was done by cdnas of ganglioside synthase genes. ecvs were collected by ultra-centrifugation, or by tim -beads. contents in ecvs were analysed by immunoblotting or flow cytometry. roles of lipid rafts in the generation and secretion of ecvs were analysed by treating cells with mm methyl β-cyclodextrin. results: using melanoma cell lines, ecvs were isolated by ultra-centrifugation, and their sizes were analysed by nanosight. all samples showed uniform sizes between and nm. protein amounts in ecvs were measured, showing heterogeneous levels at ~ μg/ ml. then, gangliosides expressed on ecvs from these cell lines were analysed using tim beads and flow cytometry. gd and gd were detected on ecvs almost proportionally with expression levels of those gangliosides on the cell surface. then, immunoblotting was performed to analyse integrin levels in ecvs from transfectant cells expressing high levels of gd , showing increased levels of integrins in ecvs from gd + cells compared with those from gd -cell lines. integrin levels in cell lysates from these cells (gd + and gd cells) were almost equivalent. treatment of a gd -expressing melanoma cell line by mm methyl β-cyclodextrin resulted in marked reduction of secreted ecvs and amounts of tsg in them. summary/conclusion: ganglioside expression patterns on melanoma cells were well reflected in the expression of gangliosides on ecvs. these results as well as increased levels of integrins in ecvs from gd + cells suggest that gangliosides and lipid rafts are involved in the generation and secretion of ecvs. introduction: hypoxia, or low oxygen tension, is a common feature associated with tumour growth and is known to regulate tumour cell function, especially through rewiring of cell metabolism. however, how hypoxia influences tumour cell interactions with surrounding cells is not fully elucidated. we sought to evaluate how hypoxia alters metabolite and metabolism-associated mirna packaging in exosomes. methods: exosomes were isolated from t breast cancer cells cultured in normoxia ( % o ) and hypoxia ( % o ) via ultracentrifugation, optiprep gradients, and size exclusion chromatography. exosomes were further characterized by nanosight, qubit protein quantification, and flow cytometry analysis of exosome markers. metabolite and mirna profiling was performed on exosomes and exosome-producing cells in normoxia and hypoxia. results: secretion of exosomes was increased under hypoxic conditions. metabolite profiling revealed alterations in metabolites specific to exosomes derived from hypoxic cells. profiling of exosomal mirna showed packaging of metabolism-related mirna into exosomes derived from hypoxic cells. summary/conclusion: hypoxia alters the metabolite and mirna profiles of cancer cells, with selective packaging of these molecules into exosomes. we identified metabolites and mirna that are depleted and enriched in exosomes compared to cells. these studies identify hypoxia-associated shifts in exosome cargo, providing insight into exosome cargo packaging with potential implications for understanding how cancer cell-derived exosomes regulate recipient cell function. lysosomotropic agents prompts the release of extracellular vesicles carrying autophagy-associated markers: evidence of a general mechanism of secretion driven by lysosomal impairment introduction: drug-induced lysosomal storage disorders (lsds) are due to the transient intracellular accumulation, mostly of phospholipids, into multilamellar inclusion bodies within late endosomal/lysosomal compartment. they represent a major side-effect for many drugs of several pharmacological categories. most lsds inducers are cationic amphiphilic drug (cad), but the molecular mechanisms leading to accumulation of undigested substrates are unknown. extracellular vesicles (evs) have been implicated in cell waste disposal, but it is unclear whether they might be involved in extracellular release of undigested substrates. methods: to investigate this aspect, we developed hek cells stably expressing the fluorescent fusion proteins egfp-cd and mcherry-cd , separated evs by differential ultracentrifugation and quantified by evassociated fluorescence and nta particle count. results: evs released by these models upon treatment with drugs inducing the accumulation of phospholipids (amiodarone) or glycosaminoglycans (tilorone), showed the release of fluorescent medium/large evs ( k fraction) and small evs ( k fraction), whose size and distribution were similar to the same vesicles released by control cells, but enhanced the recovery of medium/large evs and to a lower extent of small evs, analysis of evs associated markers revealed a dosedependent increase of autophagy-associated markers in medium/large and small evs. similar results were obtained when autophagic flux was impaired by drugs raising lysosomal ph by different mechanisms, such as chloroquine and bafilomycin, but not when autophagic flux was stimulated by drugs such as curcumin or overexpression of the endosomal/lysosomal regulator tfeb. summary/conclusion: overall results show that impairment of autophagic flux, either by indigested substrates or higher lysosomal ph, is associated with an increased release evs enriched in autophagy markers, compatible with autophagomes and/or amphisomes, unravelling a connection with secretory autophagy. tomofumi yamamoto a , yusuke yamawaki b , yutaka hattori c and takahiro ochiya a a tokyo medical university, shinjuku-ku, japan; b national cancer center research institute, chuo-ku, japan; c keio university faculty of pharmacy, minato-ku, japan introduction: multiple myeloma (mm) is a haematological tumour. last decade, the prognosis of mm has improved by the development of therapeutic drugs; however, mm cells acquire drug resistance by longterm exposure of these therapeutic drugs. one of the possible explanations of drug resistance is that cells with drug resistance transmit information to other mm cells and their microenvironmental cells. although the elucidation of the mechanism of drug resistance in mm have been desired, it remains poorly understood. methods: in order to understand the mechanism of drug resistance in mm, lenalidomide resistant cell lines were established by long-term exposure of low concentration of lenalidomide. drug resistance was assessed by mts assay and caspase assay. the amount of ev was measured by exoscreen, which is ultra-sensitive detection method of evs by measuring surface protein of evs, such as, cd and cd (yoshioka et al., nat commun., ) . to identify the genes which involved in drug resistance, rna sequence among the drug-resistant cell lines and their parental cell lines was performed. results: firstly, characterization of these cells was confirmed. we found that all of the lenalidomide resistant cell lines secreted more evs than their parental cell lines. in addition to this, the size of ev derived from resistant cells are smaller than those of parental cells. next, we collected evs from resistant cells and parental cells by using ultracentrifugation, and added them to parental cells in the presence of lethal dose of lenalidomide. compared with ev derived from parental cell lines, the evs derived from lenalidomide resistant cell lines increased a number of living parental cells. these results suggested that the evs derived from lenalidomide resistant cells can affect the lenalidomide sensitive cells. as a result of rna sequence, several genes highly expressed in resistant cell line we found, which associated with lysosome pathway. among them, attenuating the sort and lamp genes could significantly reduce the ev secretion in mm cells, leading to enhance the lenalidomide sensitivity. summary/conclusion: our results showed that ev secretion via sort or lamp could induce the drug resistance in mm. study on biological stimulate mechanism of stem cell-derived exosome generation by nanoparticles introduction: mesenchymal stem cells (mscs) are pluripotent stromal cells known to release extracellular vesicles (evs) containing various growth factors and antioxidants that can positively affect surrounding cells. nanoscale msc-derived evs, such as exosomes, have been developed as bio-stable nano-type materials, but had low yield and were difficult to quantify. we hypothesized that the mechanism of nanoparticleenhanced exosome production would stimulate intracellular molecules. the aim of this study was to elucidate the molecular mechanisms of exosome generation by comparing the internalization of surface-modified positively charged nanoparticles and exosome generation from mscs. methods: mesenchymal stem cells (mscs) were cultured in mem-alpha with % fbs and × antibiotics. the positively charged nanoparticles were synthesized by poly-lactide-co-glicolide (plga) and polyethylenimine (pei) with cy . for tracking nanoparticles. all of the exosome image were identified using an electron microscope. additionally, it was confirmed the internalization of the nanoparticles by if. the primary antibodies used were anti-eea , anti-rab and anti-gm . in order to prove the development of exosomes, rt-pcr using autophagy-related mrna was performed. real-time rt-pcr was performed using the applied biosystems sequence detection system . lastly, mirna from msc-derived exosome analysed automatically in the affymetrix data extraction protocol using the provided affymetrix genechip® command console® software (agcc). all statistical testing and visualization of differentially expressed genes was conducted using r statistical language . . results: we determined that rab , located in the mvb and autolysosomal membrane, was increased upon exosome expression and was associated with autophagosome formation. these results suggested that nanoparticles migrated to lysosomes during treatment; however, intracellular exosome-forming factors were stimulated during endosomal maturation simultaneously. summary/conclusion: therefore, msc-derived exosome research using nanoparticles is useful for increasing exosome yield and the discovery of nanoparticleinduced genetic factors. theoretical description of formation of extracellular vesicles by budding of membrane introduction: understanding mechanisms of extracellular vesicles (evs) formation is of utmost importance for their effective use in science, medicine and technology. in particular, the discovery of universal mechanisms explaining the phenomena taking place in vesiculation appears to be crucial and highly warranted. mammalian erythrocytes and giant phospholipid vesicles have been largely used as model systems to study principles of membrane budding and vesiculation. the mechanisms conveniently studied in these simple systems are then generalized to other types of biological membranes. we present a theoretical description of membrane budding and compare the theoretically obtained shapes with the observed ones. methods: in accordance with the fluid crystal mosaic model, membrane is considered as composed of constituents (inclusions) subjected to the local curvature field created by surrounding constituents. constituents can attain different in-plane orientations in the membrane which correspond to different energies. the thermal motion oposes the complete orientational ordering. the single-constituent energy expresses a mismatch of the curvature of the membrane at the position of the constituent and the intrinsic principal curvatures of the constituent and inplane orientation of their principal axes. the free energy of the whole membrane is obtained by summing up (integration) the contributions of the constituents and using methods of statistical physics, and minimized by using numerical methods. results: to outline the principle of (outward and inward) budding, respective sequences of shapes corresponding to a formation of one (outward and inward) spherical bud were calculated by minimization of the free energy. also the corresponding shapes observed in evs (imaged by electron microscopy) and in erythrocytes and giant phospholipid vesicles (imaged by optical microscopy) are shown. it can be seen that theoretically calculated shapes and experimentally observed ones agree well over up to orders of magnitude (the order of the size of giant phospholipid vesicles is between and micro metres, in erythrocytes it is about micro metres and in evs it is about nanometres). summary/conclusion: budding of the membrane is an universal mechanism in formation of external and internal vesicles. introduction: the release of extracellular vesicles (evs) from cells is important for many cellular mechanisms both in normal physiology and in disease. arrdc (arrestin domain containing protein ) is an adaptor protein known to facilitate the ubiquitination of target substrates by nedd family ubiquitin ligases. it also traffics cargo to extracellular vesicles. previous studies show the involvement of arrdc in the trafficking of the divalent metal ion transporter dmt to evs in a ubiquitin-dependent manner, and we aimed to further understand this mechanism. methods: we performed mass spectrometry to identify ubiquitinated lysine residues in arrdc . we then generated arrdc wt and lysine mutant clones and expressed these in cells to determine the effect on ev biogenesis and protein trafficking. results: mass spectrometry data identified potential ubiquitinated lysine residues. out of these, lysine appeared to be the most important for arrdc function. arrdc k r mutation caused a decrease in the number of ev released by the cell compared to arrdc wt, and a reduction in trafficking of dmt to evs. furthermore, we also observed a decrease in dmt activity and an increase in its intracellular degradation in the presence of arrdc k r. k also appeared to be ubiquitinated with k polyubiquitin chains by the ubiquitin ligase smurf . summary/conclusion: our data suggests that k polyubiquitin chains are the signal for arrdc mediated ev biogenesis and protein trafficking, and loss of this signal causes cargo to be rerouted to intracellular degradation mechanisms. chair: tanina arab -department of molecular and comparative pathobiology, johns hopkins university school of medicine a d-printed model to represent the structure and nature of extracellular vesicles, for public engagement and education events. christian burton a , sara veiga a , jason webber a , kate milward a , muireann ni bhaoighill a , lauren evans a , andreia de almeida b , rachel j. errington a and aled clayton a a cardiff university, cardiff, uk; b cardiff university, research associate, uk introduction: explaining the field of extracellular vesicles to the lay public and young audiences can often be challenging. whilst diagrams and images of evs may be helpful, conveying clearly the shape and composition of an ev by these means is not always a success. whilst many members of the audience may be familiar with concepts of cells and related structures, others will find such discussions very abstract and challenging. in order to aid interactions with lay audiences we embarked on the design of a physical hand-held plastic model, representing a typical ev. incorporating flexibility in the design allowing the community to adapt it to showcase their own research. the second goal was to ensure manufacturability using widely available dprinting technologies. methods: the basic model design was conceived by dr c. burton, and iteratively developed using solidworks, , then exported for use in any cad environment (stl format). a model showing a halved ev hemisphere, with a visible lipid-bilayer was developed. attachable rings allow trans-membrane-molecules to be represented, current designs include mhc class-i, hspgs, integrins, tetraspanins and supported by handouts accompanying the models. intraluminal cargo is included via removeable "pegs", and examples representing rna or simple globular proteins, and a template has been created. results: the design is free and open source, and available to the community at: https://www.thingiverse. com/thing: . instructions for d printing are available from the uk extracellular vesicle society website; https://www.ukev.org.uk/public-engagementmaterials/. models have been produced using entrylevel d printers and trialled at engagement events with good early responses. summary/conclusion: the authors hope the community will use and develop this d-model design and that the approach provides an additional and helpful tool for educating audiences about the complexities and roles of evs in biology and disease. centrifugal filtration-sec is promising for extracellular vesicle isolation from d and d her + breast epithelial cell lines introduction: despite recent developments in breast cancer therapy, there is still need for a more targeted approach. extracellular vesicles (evs), endogenous nanovesicles released from human cells, are an attractive choice as nanodrug carriers due to their size, stability and their unique targeting specificity. the aim of this study was to determine if centrifugal filtration (cf) combined with size exclusion chromatography (cf-sec) would be useful for ev isolation from two epithelial breast cell lines d and d her +, representing the tissue of interest, and the amount of cell culture needed to get measurable ev concentrations. methods: cell culture media (without serum) from the immortalized breast epithelial cell lines d and d her + was concentrated with centrifugal filtration (cf) followed by isolation with size-exclusion chromatography (sec) using hiprep / sephacryl s- column run with Äkta start ( nm), min runs. each fraction ( - ml) was collected with fraction collector. dulbecco's particle free pbs was used as mobile phase. the resulting particles were analysed with nanoparticle tracking analysis (nta, nanosight ns , camera gain , static mode, capture time sec), western blotting (wb), microbca and transmission electron microscopy (tem, samples fixed with % formaldehyse and stained with % uranyl acetate, run at kv). results: although sec did not show any prevalent peaks from early eluting regions previously shown to contain extracellular vesicles, these fractions (f -f , - min) were collected from d her + cell culture medium. interestingly, both nta and tem suggest that f and f contained evs as the isolated particles measured and nm, respectively and tem revealed spherical particles - nm in diameter. wb was unable to detect the ev associated protein alix (but was present in the whole cell lysate). soluble proteins and protein aggregates eluted late in the sec chromatogram ( min), with protein analysis (microbca), tem and wb confirming their presence. summary/conclusion: cf-sec is a promising method for ev isolation for pharmaceutical applications, but further work is needed to optimize the isolation process using Äkta start for these cell lines. customer stories from the ev core of university of helsinki introduction: the ev core, world's first ev-dedicated technology platform established in , is a joint venture of two extracellular vesicle (ev) research laboratories at university of helsinki. as an academic research/service facility, the ev core provides infrastructure, state-of-the-art and emerging ev-technologies for research groups, hospitals, companies and authorities in the ev-field. the ev core provides ev isolation, purification and characterization services and offers contacts to downstream analyses in other core facilities based on optimized ev protocols. here, we present and discuss the customer experiences and prospects with the aim to further develop ev core services. methods: our most wanted services are nanoparticle tracking analysis, electron microscopy, ev isolation and rna isolation and consultation. currently, the key down-stream analysis methods are (mi)rna sequencing, metabolomics, flow cytometry and functional assays. results: we present the stories from our customers starting with their research questions and need for the ev expertise/consultation and equipment. next, we show how the projects advanced and what types of ev core -derived or other downstream services helped them to achieve their aims. in the end, we will acknowledge the customers experience and current status of their research. summary/conclusion: narratives of customer stories are an effective starting point for fruitful discussions about the current status and next developments in the young ev service field. recent isev workshops: open, reproducible and standardized ev research (ghent, ) and evs in immunology (buenos aires, ) introduction: since its founding in , isev has sought to further extracellular vesicle research in various ways including scientific meetings. these events encompass annual meetings as well as smaller, topically focused workshops, with the first isev workshop (on rna and evs) organized in new york city in october, . in december, , the workshop "open, reproducible, and standardized ev research" was held in ghent, belgium. in march, , the workshop, "evs in immunology" was held in buenos aires, argentina, with a preceding education day. methods: the international organizing committees of the and isev workshops prepared scientific programs around key themes of ev rigour and standardization (ghent, belgium, workshop) and evs in immunology (buenos aires, argentina, workshop). abstract and application submissions were invited. applications were reviewed and ranked by panels of ev experts for each event, and participants were invited. results: the and workshops assembled a total of more than individuals for talks and discussions around the themes of rigour and standardization and evs in immunology. the buenos aires workshop was preceded by an education day, coordinated by the isev executive committees for education and science and meetings. during these two workshops, poster presentations were permitted for the first time, affording additional presentation and interaction opportunities. the rigour and standardization workshop also featured real-time discussant polling to facilitate discussion. summary/conclusion: isev workshops such as those addressing rigour and standardization (ghent, ) and evs in immunology (buenos aires, ) continue to provide opportunities for focused discussion of small groups of experts on key topics in the field. often followed by published products, isev workshops help to lead and coordinate progress in ev science. for future isev workshops, educational activities may again expand the reach of each event, while poster sessions and app-driven real-time responses should be considered for enhanced interactions and participant canvassing. ev journal club: exchanging pizza for a worldwide audience during covid- kenneth w. witwer johns hopkins university school of medicine, baltimore, usa introduction: a monthly journal club focused on extracellular vesicle science was established at johns hopkins university in , featuring lunch and presentations by academic and industry participants. when covid- prevented in-person meetings beginning in march, , the journal club was converted to a virtual, weekly format on the popular online meeting app zoom. the journal club has persisted despite initial problems with online vandalism. most sessions are also made public on a youtube channel, https:// www.youtube.com/c/extracellularvesicleclub. methods: weekly ev club sessions are arranged by the host. most focus on a specific manuscript related to evs, but some weeks feature presentations of published or soon-to-be-published research by the presenting authors. sessions are advertised one week to several days in advance on social media platforms such as linkedin, twitter, and facebook, asking interested parties to sign up to join a mailing list via surveymonkey. the log-in information is then sent to the mailing list. upon clicking the link, participants are placed in a virtual waiting room for vetting by the host and volunteers. after admission, all parties but the host and presenter are muted to avoid distractions. questions and comments may be placed in a chat box. contributions are monitored and compiled by the host and volunteers to build a question-and-answer session at the end of the presentation. recorded sessions-with or without editing as needed-are placed on the youtube channel for additional access. results: despite initial problems with online vandalism known as "zoombombing," the journal club has continued weekly during the covid- shutdown in the host country (us). an audience of between and individuals is typical. participants typically ask more questions than can be answered in a one-hour time frame. the online format also allows for debate-style events and polling of the audience. summary/conclusion: this ev journal club is an example of how online tools can be used to facilitate international scientific interactions. further development of such formats could provide alternative approaches for isev activities in the science, education, and communication areas. the study aim is to assess whether the exposure to pm and pm , , chosen as paradigmatic environmental stressors, could modify the composition of nasal microbiota (nm) and extracellular vesicle (ev signalling network, showing a role in allergic ar exacerbation). methods: nm analysis were performed on v -v s rrna gene regions amplified from upper-airway tracts of ar cases and healthy individual controls to perform nm analyses. ev size, concentration and cellular origin for each subject were assessed by nanoparticle tracking analysis (nta) and flow-cytometry (fc). information on daily pm and pm , concentrations at the municipality of residence in the days preceding nasal sampling (i.e. day − to day − ) was assigned to each subject by arcgis software. multivariable and logistic analyses were applied on nm, nta and fc outcomes. results: when taxonomy composition was considered, in controls actinobacteria ( . %) was the most represented, followed by firmicutes ( . %) and proteobacteria ( . %) while in cases proteobacteria were . %, actinobacteria were . % and firmicutes were . %. cases showed a higher concentration of all the investigated ev types, derived from platelets (cd +), activated endothelium (cd e+), monocytes (cd +), eosinophils (cd +), neutrophils (cd +), mastocytes (cd c+), epithelial cells (epcam+), gram+ bacteria (lipoteichoic acid+), gram-bacteria (lps+). the effect was greatest in the case of mastocytes evs which were increased . fold in cases versus controls (p < . ). evs were modified by pm exposure at several time lags. in particular, a negative association between pm and eosinophil evs was observed (beta = − , ; pvalue = , ). as we clustered subjects according to their nm, we observed this variable was a strong effect modifier of the association between pm exposure and ev release. summary/conclusion: our findings start to provide an insight on the effect of air pollution on evs, taking into account the effect of nm, in patients with ar. further research is necessary to disentangle the mechanism exerted by inhaled pollutants in modulating evs and nm, and therefore ar exacerbation. funding: gsk investigator sponsered study aryl hydrocarbon receptor activation induces the expression of specific microrrnas in th cells that are release into extracellular vesicules and associated with arthritis introduction: in rheumatoid arthritis (ra), an autoimmune disorder characterized by a chronic sinovial inflammation, smoking is a major risk factor contributing to disease progression, and poor response to therapy. th cell is actively involved in worsening smooking-associates inflammation mediated by aryl hydrocarbon receptor (ahr), a cytoplasmic transcription factor involved in xenobiotic metabolism. both, ahr and th cells, has important implications during ra development. considering that cigarette smoke is a potent epigenetic modifier, we hypothesized that ahr activation, by cigarette components, would transcribe specific micrornas in th cells as a molecular mechanism to exacerbate inflammation in arthritis. methods: microrna expression was evaluated by largescale approach or real-time pcr. c /bl and ahr null mice were submitted to arthritis experimental models and exposed or not to cigarrete smoke (ethical committee approved / ). extracellular vesicles (evs) were isolated by ultracentrifugation, and characterized by western blot and nanosight. rankl-induced osteoclasts (ocs) differentiation in vitro was stained for trap. inhibition of mirnas were performed using anti-mirs transfection. results: we identified a specific group of mirnas induced in th cells after ahr activation. during arthritis progression, the micrornas are expressed and increases after exposure to cigarette smoke. in the absence of ahr their levels were drastically reduced. interestingly, we found that these micrornas are released by th cells into evs, and are able to promote osteoclastogenesis. ocs differentiation in vitro increases in the presence of th -derived evs, and this process is reduced in the absence of micrornas. summary/conclusion: microrna-mediated gene regulation plays crucial roles in the immune system functions, and their abnormal expression is highly correlated with the pathogenesis of ra. evs are known to function in cell-to-cell communication and are able to transmit their contents and cause changes in the target cell. our findings demonstrate a new molecular mechanism by which cigarette smoke could aggravate inflammation in arthritis; through the activation of ahr receptor in th cells, inducing the transcription of specific micrornas that are released into evs, and act as pro-inflammatory mediators. introduction: chagas disease (cd) is caused by the flagellated protozoan t. cruzi. trypomastigote forms are capable of releasing extracellular vesicles (evs) that contain the major surface molecules of the parasite. the parasite has a complex life cycle that leads to it a rapid adaptation in the environmental changes in the hosts. however, the effects of stress on on evs release are not completely understood. objetive: we evaluated the release of evs by trypomastigotes incubated under different stress conditions and the immunomodulatory role of these evs in pre-activated bone marrow-derived macrophages (bmdm). methods: nanoparticle tracking analysis (nta) and scanning electron microscopy (sem) showed an increase in evs releasing by trypomastigotes at °c under acidic conditions, evs released was affected and triggered amastigogenesis process. results: treatment with sodium azide (nan ) also caused changes in the release of evs regarding size and concentration. nitrosative stress caused by sodium nitrite (in culture medium mildly acidic, ph . ; in this condition nano releases nitric oxide) stimulated an increase in production of evs by t. cruzi. when the parasites were treated with nm s-nitrosoglutathione (snog), we observed a reduction in size and concentration of vesiculate material by trypomastigotes. at a higher snog concentration ( µm), the concentration of the vesiculate material increased. t. cruzi-derived evs exposed to stress conditions increased the expression of inos, arg , il- and il- genes in ifn-γ and lps pre-activated bmms. summary/conclusion: results suggest that the viability and/or integrity of the parasite are necessary for the evs releasing. in those in vitro conditions they triggered a proinflammatory response in host cells. this may be a strategy developed by the parasite to favour its establishment in the host. funding: fapesp, cnpq, capes and fapemig ppm-x / . immuno-toxicological evaluation of human mesenchymal stem cell- introduction: mesenchymal stem cells (mscs) have been widely used to the field of autoimmune diseases or tissue regeneration therapy. recently, many research groups have reported that mscs showed their ability via secreted paracrine mediators including extracellular vesicles (evs) rather than cell-to-cell contact. mscs mainly exist on bone marrow, peripheral blood, umbilical cord and adipose and can mostly secrete evs. it has emerged that evs alone are responsible for the therapeutic effect of mscs in plenty of animal diseases models. hence, msc-derived evs may be used as an alternative msc-based therapy in regenerative medicine. methods: as part of safety programme for human therapeutics, we performed immunotoxicological assessment of evs obtained from human mscs (hevs) in mice and human peripheral blood mononuclear cells (hpbmcs). firstly, mice were treated intravenously with a negative control, a positive control (lps; . mg/kg), or low-dose ( x e paticles/head) and high-dose ( x e paticles/ head) of hevs every other day for days and then analysed lymphocyte subsets from collected spleen by facs. next, we treated the evs on hpbmcs for days with low conc. ( x e particles/ml), high conc. ( x e particles/ml), pma/ionomycin as a cell activator or cpt ( μm) as an apoptotic inducer. annexin v/pi and csfe were analysed by facs. results: as a result, splenic nk cells and b cells were slightly increased about ~ % in hevs-treated mice, without biological significance, compared with a positive control (lps) as an immunogenicity inducer. and there were no effects on serum levels of inflammatory cytokines in mice. in addition, hevs had no cytotoxic effect on hpbmcs at both low and high conc. under the culture medium with evs-depleted fbs, the hevs appeared minimal anti-apoptotic effect on hpbmcs. for the cfse assay, the hevs showed slight proliferation on hpbmcs and pbmc activation induced by pma/ionomycin. summary/conclusion: in conclusion, the hevs have little immuno-toxicological effects in mice and hpbmcs. further detailed studies to elucidate immunological response of hevs for development of human therapeutics are needed. funding: this research was supported by a grant ( mfds ) from ministry of food and drug safety. investigation of immune response to mesenchymal stem cell-derived extracellular vesicles in the cancer setting introduction: mesenchymal stem cell-derived extracellular vesicles (msc-evs) are thought to be a fingerprint of the secreting cell and therefore may retain the cancer targeting and immune privilege of mscs. thus msc-evs hold immense potential as tumour-targeted therapeutics for breast cancer. the aim of this study was to determine whether msc-ev administration in tumour bearing immunocompetent animals would initiate an immune response. methods: evs were isolated from conditioned media of both human and murine bone marrow-derived mscs through sequential differential centrifugation, microfiltration and ultracentrifugation. evs were characterized by nanoparticle tracking analysis (nta), western blot and transmission electron microscopy (tem). x ( ) human or murine msc-evs were administered intravenously into t breast tumour bearing balb/c mice (n = ) and healthy controls (n = ). tumour tissue, draining lymph node and spleen were then harvested, dissociated and flow cytometry performed targeting markers associated with a range of immune cells including t-cells, macrophages and natural killer (nk) cells. results: evs were successfully isolated from murine and human mscs with the appropriate size of small evs (sevs: - nm) and morphology including a lipid bilayer observed by tem. evs expressed tetraspanins cd , cd , cd ; cytosolic protein tsg and were negative for calnexin. ev concentrations ranged from . x ( ) - . x ( )/ml. in order to study a range of immune cell populations two antibody panels were created using complimentary fluorescent dyes. the proportion of t-cells (cd +, cd +, cd +), neutrophils (gr- +, ly- c+), dendritic cells (cd c+), macrophages (cd b+, mhci+, mhcii+), nk cells (cd +) and b cells (cd +) remained stable in the tumour, draining lymph node and spleen of all tumour-bearing animals that received either human or murine msc-evs, with no significant change observed in any category. summary/conclusion: the data presented supports the hypothesis that msc-evs retain the immune privilege of the secretory cell, with human cell-derived evs illiciting no immune response in mice. this is encouraging and reinforces the potential for use of msc-evs in the therapeutic setting. introduction: mycobacterium avium (m. avium) is a slow growth rate non-tuberculous mycobacterium (ntm). m. avium infection is a severe global health problem. but the mechanisms of pathogenicity of m. avium are poorly understood. outer membrane vesicles (omvs) that traverse the cell wall and contain a varied bioactive components inculding dna, rna, protein and toxins. previous studies have suggested that these omvs are produced in vitro and during animal infection, but the role of omvs secretion during the interaction of m. avium with host cells remains unknown. methods: in this study, m. avium were grown in middlebrook h medium (m h ) supplemented with % (v/v) oadc enrichment and . % (v/v) glycero. m. avium omvs were isolated by ultracentrifugation method. characterization of omvs by transmission electron microscopy (tem) and nanoparticle tracking analysis (nta). the raw . murine macrophages were incubated with the m. avium omvs to analyse inflammatory response and production of nitric oxide (no) and reactive oxygen species (ros) of macrophage. results: in this study, we demonstrate by fluorescence microscopy that murine macrophages can phagocytosis omvs produced by m. avium. incubation of m. avium omvs with murine macrophages resulted in increased levels of extracellular tumour necrosis factor alpha (tnf-α), interleukin- β (il- β), terleukin- (il- ) and interleukin- (il- ). meanwhile omvs stimulated macrophages produce no and ros. introduction: hospital associated venous thromboembolism (ha-vte) in paediatric patients is the second most common contributor to harm in hospitalized children. platelet-endothelial interactions are integral to the formation of vte, especially in inflammatory conditions such as sepsis. small extracellular vesicles (sevs) have the ability to reprogramme target cell phenotypes via their microrna contents and are known to contribute to vte formation. we hypothesize that sepsis alters platelet-derived sev micrornas capable of net upregulation of vascular endothelial procoagulant and downregulation of anticoagulant pathways. methods: using a precipitation solution and size exclusion chromatography, we isolated sevs from platelet poor plasma of children admitted to the paediatric intensive care unit for sepsis and from healthy controls. we positively selected platelet-derived sevs using immunomagnetic isolation for cd b platelet antigen and confirmed selection using flow cytometry. microrna was profiled using affymetrix genechip mirna . array. results: microrna from sepsis patients (median age . years; iqr: . - and % female) with a median psofa score of (iqr: . - ) and from healthy controls (median age years; iqr: . - . and % female) was isolated and compared. in septic vs. healthy patients mirnas were differentially expressed (false discovery rate (fdr)< . ; fold change ≥| . |) affecting mrna pathways. in septic children, pathways affecting chemotaxis and cell movement of leukocytes were predicted to be activated with z-scores ≥ . summary/conclusion: we developed a method to successfully isolate platelet-derived sevs. sepsis alters the platelet-derived sev microrna profile in paediatric patients with sepsis. these micrornas are predicted to target chemotaxis and cell movement pathways, important contributors in the formation of ha-vte. further analysis into specifically targeted pathways should be conducted as a potential target for the prevention of ha-vte in sepsis. introduction: sjögren´s syndrome (ss) is a systemic autoimmune disease that mainly affects salivary and lacrimal glands. mechanisms of ss pathogenesis are poorly understood. it is thought that inflammation leads to destruction of exocrine glands, however the triggers of autoimmunity and the mechanisms by which inflammation drives immunopathology are not characterized. our work identifies t cell-exosomederived mir- - p as a pathogenic driver of immunopathology in ss. micrornas (mirnas) are endogenous small noncoding rna molecules that regulate the expression of target genes through translational repression of mrnas. through transcriptomic profiling studies our group had previously documented a significant upregulation of mir- - p in patient ss tissues and in serum exosomes. methods: structured search for target genes of mir- - p involved in salivary gland (sg) physiology was performed with mirdip . serca b, ryr and ac were selected for further validation and functional analysis. binding of the mirna was confirmed by luciferase reporter assays in hsg cell lines and human-derived primary epithelial cells. the mrna and protein levels of serca b, ryr and ac were determined by qpcr and western blot, respectively. to investigate the cell-specific distribution of mir- - p in relation to the expression levels of serca b, ryr , and ac , a double fluorescent in situ hybridization was performed. ca + signalling and camp levels were measured using fluorescent sensor. to isolate exosomes, the t cell medium and serum of ss-patients and healthy volunteers (hv) were collected. results: we show that mir- - p is over-expression in the sgs of ss-patients. next, we demonstrated that mir- - p is contained in exosomes in serum of sspatients significantly more than serum of hv. we also show that activated t cells secrete exosomes containing mir- - p which transfer into glandular cells and affecting intracellular ca + signalling, camp production and protein production by mir- - p targets (serca b, ryr and ac ). summary/conclusion: this study provides evidence for a functional role of the mir- - p in ss pathogenesis and promotes the concept that t cell-activation directly may impair epithelial cell function through secretion of mi-rna containing exosomes. treg-derived il -coated extracellular vesicles promote infectious tolerance (p ) subunits, yet the forms that il assumes and its role in peripheral tolerance, remain elusive. methods: we induce cba-specific, il -producing t regulatory (treg) cells in tregebi wt c bl/ reporter mice, and identify il producers by expression of ebi tdtom gene reporter, plus ebi and p proteins. results: curiously, both subunits of il were displayed on the surface of tolerogen-specific foxp + and foxp neg (itr ) t cells. furthermore, il producers, although rare, secrete ebi and p on extracellular vesicles (ev) targeting a -to -fold higher number of t and b lymphocytes, causing them to acquire surface il . this surface il is absent when ev/exosome production was inhibited, or if ebi is genetically deleted in treg cells. summary/conclusion: the unique ability of ev to coat bystander lymphocytes with il , promoting exhaustion in, and secondary suppression by, non-treg cells, identifies a novel mechanism of infectious tolerance. funding: nih grants r -ai - (to w.j.b.), r ca and p ca (to d.a.a.v.) and the university of wisconsin carbone cancer center support grant p ca . unique formulated dual targeting antigen specific and delivered mirna- gene regulating exosomes acting at the immune synapse to induce apc-derived secondary suppressive exosomes introduction: an exosome-apc circuit we uncovered may be applicable beyond skin immunity we study in mice. methods: high antigen dose tolerized cd + t cells make suppressive antigen-specific exosomes due to chosen surface antibody light chains that enable targeting antigen presenting cells (apc) antigen-specifically for delivery of also chosen inhibitory mirna- to mediate specific functional gene alterations. results: both antigen and gene specificity aspects are lent to naïve but activated exosomes by simple in vitro incubations alone. for mechanism, these primary exosomes bind antigen peptides in mhc on apc that in turn make secondary suppressive exosomes that act peptide/mhc-specifically on the effector t cells at the immune synapse. they transfer another mirna for strong prolonged inhibition of active delayed-type hypersensitivity (dth) for days even, when the primary mirna- -pos exosomes are administered orally at the height of the in vivo response, in a physiological dose. summary/conclusion: it is shown possible to induce therapeutic exosomes with ag targeting of choice due to placed ab on the surface and that also target specific gene functions of acceptor cells due to carriage of a selected mirna. this dual ag and gene-specific therapy has applications in treatment of cancer, autoimmunity and allergies. introduction: previously, our group characterized distinct populations of extracellular vesicle (ev) released from neutrophilic granulocytes: ev formed spontaneously (sev) and upon activation with opsonized particles (aev). the aev differs in protein cargo and its ability to inhibit bacterial growth. we described that mac- integrin (cr receptor) plays key role in the aev production and extracellular calcium supply is crucial in this signalization. in the present work, our aim was to investigate whether mac- activation or casignalling on their own are sufficient for the initiation of the aev biogeneis. methods: we isolated neutrophil derived evs from peripheral human blood and murine bone marrow by two-step centrifugation and filtration. we tested the effect of ca-ionophore and examined the ev production on c bi coated surface and in soluble form. we quantified the vesicles by flow cytometry and determined their protein content by bradford assay. we examined their antibacterial effect in parallel with optical density-based measurement and our flow cytometry based method. results: on c bi coated surface, we observed an increased ev production, and these evs possessed antibacterial capacity. however, in soluble condition, c bi did not induce further ev production, and these evs did not show any antibacterial property. we found that ca-ionophore initiated ev formation, but these ev did not show antibacterial effect. we observed ev production increase after ca-ionofore treatment both in the presence and in the absence of extracellular ca. the ca-ionophore slightly increased the opsonized particle induced ev production, but did not potentiate their antibacterial capacity. summary/conclusion: mac- activation is not just crucial, but sufficient in initiation of the aev biogenesis. clustering of this receptor is required. while the ca-signal is crucial, it is not sufficient in the generation of aevs. extracellular vesicles and their microrna cargo in retinal health and degeneration: mediators of homoeostasis, and immune modulation yvette s. m. wooff, adrian cioanca, riemke aggio-bruce, joshua chu-tan, ulrike schumann and riccardo natoli the australian national university, canberra, australia introduction: photoreceptor cell death and inflammation are known to occur progressively in retinal degenerative diseases such as age-related macular degeneration (amd). however, the molecular mechanisms regulating these biological processes are largely unknown. extracellular vesicles (ev) are essential mediators of cell-to-cell communication with emerging roles in the modulation of immune responses. evs, including exosomes, encapsulate and transfer microrna (mirna) to recipient cells and in this way can modulate the environment of recipient cells. dysregulation of evs however is correlated to a loss of cellular homoeostasis and increased inflammation. in this work we investigated the role of isolated retinal small-medium sized ev (s-mev) in the regulation of homoeostasis and immune modulation in both the healthy and degenerating retina. methods: isolated s-mev from healthy and degenerative (photo-oxidative damaged) mouse retinas were characterized using dynamic light scattering, transmission electron microscopy and western blot, and quantified using nanotracking analysis. small rna-seq was used to characterize the mirna cargo of retinal s-mev isolated from healthy and degenerating retinas. finally, the effect of exosome inhibition on s-mev-mediated immune modulation was investigated using systemic daily administration of exosome inhibitor gw and analysed by in situ hybridization of s-mev-abundant mirna. electroretinography and immunohistochemistry were performed to assess functional and morphological changes to the retina as a result of exosome depletion. results: our results demonstrated an inverse correlation between s-mev concentration and photoreceptor survival, with decreased s-mev numbers following retinal degeneration. small rna-seq revealed that s-mevs contained uniquely enriched mirnas, however no differential composition in s-mev mirna cargo following photo-oxidative damage was observed. exosome inhibition using gw exacerbated photoreceptor degeneration, with reduced retinal function and increased levels of inflammation and cell death seen following photo-oxidative damage. further, reduced translocation of the photoreceptor-derived s-mev was demonstrated following exosome-inhibition in photo-oxidative damaged mice. summary/conclusion: taken together, we propose that retinal s-mev and their mirna cargo play an essential role in maintaining retinal homoeostasis through immune-modulation, and have the potential to be targeted using gene therapy for retinal degenerative diseases. impacts of agricultural dust exposure on human lung-resident mesenchymal stromal/stem cells and their extracellular vesicles introduction: agricultural dust is considered a high-risk occupational hazard by the cdc, with impacts reaching throughout the communities surrounding these industries, leading to increased incidence of respiratory illness and disease among individuals within this occupation and these communities. lung-resident mesenchymal stromal/stem cells (lr-msc) have an important role in maintaining homoeostasis in the lung, and mediating pro-and anti-inflammatory effects, particularly during exposure to inhaled irritants, like agricultural dust. one way in which these lr-msc promote lung homoeostasis is through the release of extracellular vesicles (ev), with a variety of cargo that elicit changes among target cells. we hypothesize that exposure to agricultural dust modifies the quantity and cargo of ev released by lr-msc to promote lung tissue homoeostasis. methods: primary human lung-resident mesenchymal stromal cells were exposed to extracts of dusts collected from swine confinement facilities (de) for or hrs and the media from these exposures were collected and enriched for ev by opti-prep density gradient ultracentrifugation. the quantity of these ev were assessed by nanoparticle tracking analysis. additionally, cytokine and chemokine release by lr-msc were analysed by enzyme-linked immuno assays. results: as assessed at hr following treatment, deexposed lr-msc released pro-inflammatory cytokines, il- and il- , with il- release reaching statistical significance at . %, . %, and % de concentrations (p = . , < . , and < . respectively) and il- trending a similar dose response but only statistically significant at % de (p = < . ). de exposure of lr-msc also induced changes in the lr-msc-derived ev populations when compared to vehicle control, where lr-msc released significantly more ev in the and % iodixanol fractions (p = < . and . , respectively) at hr following de treatment. alternatively, there were significantly less ev in the and % density fractions in the media of deexposed lr-msc versus vehicle control. summary/conclusion: following exposure to agricultural dusts, lr-msc-derived ev populations more likely consist of exosomes and ectosomes, which play an important role in promoting lung tissue homoeostasis during exposure-related pulmonary inflammation. introduction: during analyses of single extracellular vesicles (evs) by flow cytometry (fcm), particles below the detection limit may exceed the trigger threshold, which is called swarm detection and generates false-positive counts. serial dilutions are recommended to find the minimal dilution for which swarm detection is absent. however, because particle concentrations in plasma vary, the optimal dilution differs > -fold between donors, but it is unfeasible to do serial dilutions for each clinical sample. therefore, our aims are to ( ) develop a faster method to avoid swarm detection, and ( ) increase the number of detected evs per second. methods: we measured serial dilutions of cd stained evs in platelet free plasma (pfp), with and without spiking of fitc beads, by fcm (apogee a -micro). we triggered either on side scatter or fluorescence. results: for scatter triggering with our fcm, swarm detection consistently occurred for plasma samples exceeding a (total particle) count rate of , - , events/s. the cd + evs concentration scaled linearly over . orders of magnitude of the dilution and most donors required > -fold dilution to avoid swarm detection, thereby reducing cd + ev counts. for fluorescence triggering, the cd + evs concentration scaled linearly over > orders of magnitude of the dilution. for all donors, swarm detection was absent after -fold dilution (relative to pure plasma). the count rates of cd + evs were - -fold higher compared to scatter triggering. the spiked fitc beads confirmed that the median signals remained constant. summary/conclusion: we have developed two clinically applicable ways to avoid swarm detection. for scatter triggering, the count rate provides direct feedback on the presence of swarm detection in plasma samples. for fluorescence triggering, swarm detection was absent for all plasma samples diluted ≥ -fold and compared to scatter triggering, count rates of cd + evs were - fold higher, thereby improving statistical significance. funding: edwin van der pol is supported by the netherlands organisation for scientific research -domain applied and engineering sciences (nwo-ttw), research programmes veni . benchmarking flow cytometric analysis of nanoparticles: a cross-platform study for single extracellular vesicle detection introduction: despite flow cytometry being widely used to analyse cells in suspension, most commercial instruments lack sensitivity when measuring nanoparticles (nps) and extracellular vesicles (evs). furthermore, the use of appropriate reference materials (rms) for calibration and quality control are essential to compare results acquired with different instruments. to work towards successful clinical applications for ev biomarker profiling, benchmarking studies including state-of-the-art flow cytometers are required. we here investigated the ability of three different flow cytometers to detect nps and evs. methods: the instrument sensitivity of light scattering detection was evaluated by using synthetic nps of different sizes and refractive indices. fluorescent calibration was investigated by using molecules of equivalent soluble fluorophores (mesf) beads. biological recombinant evs (revs) were used to validate the detection and quantification of fluorescent evs in a side-by-side cross-platform study using an n nanoflow analyser (nanofcm), an optimized bd influx and a cytoflex lx. results: we found that when light scatter based detection was used, the nanofcm detected the smallest non-fluorescent nps, the bd influx was able to provide reliable fsc information from the smallest detected nps and the cytoflex performance was greatly improved by the use of violet-ssc. biological revs showed that the nanofcm could clearly resolve fluorescent evs while the bd influx and cytoflex were unable to fully resolve revs from background, although fluorescence threshold improved detection. in addition, our findings revealed that different concentrations are required to ensure single ev detection in these platforms. summary/conclusion: we identified several strengths and limitations for each platform with respect to single ev analysis. furthermore, our results showed that proper calibration and rms are of utmost importance to ensure reliable interpretation of ev flow cytometric data. caution when using membrane dyes for sequential extracellular vesicle analysis diana pham, michael wong, desmond pink and john lewis nanostics, edmonton, canada introduction: confirmation that particles detected by microflow cytometry are actually extracellular vesicles (evs), or at least membranous in composition, can be achieved through a variety of methods. positively staining particles with a membrane dye strongly suggest that the particle contains a membrane; loss of stain (or detection) after detergent solubilization of the membrane-dyed particles provides even stronger evidence that the particles were evs. it is important to recognize that the labelling protocol provided by the membrane dye manufacturer may not be ideal for all types of evcontaining biological samples, such as blood, urine, semen etc.). removal of excess dye from stained evs is very difficult and can be impractical depending on the nature of the experiment. however, this means that the potential for excess dye to contaminate subsequent sampling is high. therefore, it is important to determine optimal working concentrations and labelling conditions when using membrane dyes for ev detection to understand properties that may impact your analyses. methods: to assess the utility of membrane dyes, titration curves were generated to determine the optimal working concentrations of membrane dyes for ev detection in conditioned media and human serum samples. once the optimal concentration was determined the potential of dye carry-over from sample to sample during microflow cytometry detection was evaluated by tracking dye positive (dye+) particles in phosphate buffered saline (pbs) blanks and matched, unlabelled, sample replicates. results: we found that optimal concentration of any membrane dye is dependent on sample type. even with the inclusion of system washes to prevent sample carryover, there was carryover of low amounts of dye+ particles into sequentially analysed pbs blanks. if unstained samples were analysed following a stained sample, excess dye (or at least dye+ events) appeared in the data. a sample concentration effect was also seen; samples of lower concentrations were more susceptible to dye carryover. summary/conclusion: when using membrane dyes to stain evs in biological samples, especially if an autosampler is employed to run a series of tests, it is critical to determine the optimal concentration of dye for each type of sample, as excess dye can carry over to the next sample in the queue. in addition, determining the necessary steps to clean any excess dye following each sample run will improve the accuracy of ev detection and analyses. funding: nanostics alberta innovates alberta cancer foundation correlation between size and protein expression of single exosomes by combined atomic force and fluorescence microscopy introduction: there are no universal markers of extracellular vesicles, but often they are identified by the presence of tetraspanins in their membrane. based on this, products have been developed to precipitate or quantify evs by acting upon cd , cd , and cd . however, evs also carry proteins from their parent cells, and capturing evs based their presence allows for a more complete understanding of vesicle heterogeneity from a single cell type, and for evs derived from specific tissues to be enriched from other biofluids in support of biomarker assessment. for example, evs derived from the brain could be captured from the general population of serum evs for better assessment of cargo associated with proteinopathy. the goal of this study was to identify specific antibodies to capture and label evs bearing the neural markers cd , snap , α-synuclein, tau, and ncam. methods: the targets were overexpressed in hek t cells through transient transfection of plasmids (origene). media was conditioned for - hours, and then centrifuged to remove cell debris. cell lysates and concentrated conditioned media (cm) were analysed by western blot. unpurified cm, or cm after performing size exclusion chromatography (sec, izon), were analysed in the exoview r system. diluted cm was incubated on custom antibody microarray chips overnight. then the chips were labelled with a cocktail of labelled antibodies, washed and imaged. vesicles were counted, sized, and phenotyped. next, commercially available pooled human csf was analysed in a similar fashion to determine their abundance in a relevant biofluid. results: multiple antibody clones were tested in different combinations for capture and labelling for the five different neuronal enriched proteins of interest, and optimal combinations were identified. some markers were identified on particles > nm in size that were negative for tetraspanins, while others colocalized with tetraspanins. through comparing permeabilized and intact evs with and without sec to remove non-vesicular proteins, we found that tau could be on the vesicle surface, within the vesicle, and free in solution. summary/conclusion: the exoview platform can be customized to enable the detection of proteins of interest and to determine whether they are on the ev surface, intravesicular, or non-ev associated. methods: forty non-smoking male and female subjects ( - y) at moderate risk for cvd were recruited for the study. evs from platelet-free plasma (pfp) were isolated using size exclusion chromatography (sec). the concentration and size distribution of evs were measured by nanoparticle tracking analysis (nta) and flow cytometry (fcm). three ev markers, including annexin v for the circulating phosphatidylserinepositive (ps+) evs, cd for platelet-derived evs and cd for endothelial-derived evs were used for phenotyping. in addition, coagulation and fibrinolysis were assessed using a thrombodynamics analyser (hemacore). platelet aggregation to determine platelet function was assessed by a high-throughput platelet function assay with a wide range of concentrations of agonists, including adenine diphosphate (adp), collagen-related peptides (crp-xl), epinephrine, thrombin receptor activating peptide (trap- ) and u . the association between thrombogenic risk markers for cvd and ev numbers was tested by pearson's correlation coefficient and linear regression model using the statistical program, spss. results: circulating ev concentration with threshold of nm, measured by nta, were positively associated with coagulation-related risk markers, including rate of clot growth (r = . ; p = . ) and clot size at min (r = . ; p = . ). ps+ evs derived from endothelial cells, determined by fcm, were negatively associated with lysis onset time (r = − . ; p = . ), whereas they were found positively correlated with lysis progression (r = . ; p = . ). both mean and mode size of cevs, detected by nta, were significantly correlated with u -induced platelet aggregation (r = − . ; p = . , r = − . ; p = . , respectively). summary/conclusion: in subjects at moderate risk for cvd, cev numbers were positively related to rate of clot growth and clot size and size of cevs was negatively related to platelet activity. higher numbers of endothelial cell-derived ps+ cevs were associated with lower rates of fibrinolysis. this suggests that cevs promote clot growth and reduce fibrinolysis, and may therefore be an indicator for greater risk of cvd. beyond stem cells: extracellular vesicles from human induced pluripotent stem cells (hipsc) and hipsc-cardiomyocytes as therapeutic approaches for heart failure introduction: heart failure is caused by a variety of underlying diseases, the most common being myocardial infarction. initially regarded as an alternative to pharmacological approaches, stem cell transplantation has failed to demonstrate clinically meaningful results. instead, it has become increasingly apparent that the therapeutic effects of transplanted cells are largely mediated by their secretome, while mounting evidence suggests extracellular vesicles (evs) play a major role in cardiac repair. within this framework, evs from human induced pluripotent stem cells (hipsc) and hipsc-derived cardiomyocytes (hipsc-cm), hold a tremendous potential to treat cardiovascular disease. we isolated evs from conditioned culture media at key stages of the hipsc-cm differentiation and maturation processes, i.e. from hipsc (hipsc-ev), cardiac progenitors (cpc-ev), immature (cmi-ev) and mature (cmm-ev) cardiomyocytes, with the aim of studying their potential role as therapeutics, and whether their effectiveness was influenced by the state of their parent cell. methods: hipsc were differentiated into cardiomyocytes in a d culture approach, using the protocols developed by our group. ev isolation was performed on an iodixanol density gradient, and the evs were characterized in terms of particle size and particle size distribution, presence of ev-specific markers, and imaging through transmission electron microscopy. functional studies were performed using human umbilical vein endothelial cells (huvecs) to evaluate evuptake, cell migration and angiogenesis. results: evs from all hipsc and cardiac derivatives presented a typical cup-shaped morphology and expressed cd and cd . ev yield varied along differentiation, with a minimum for cpc and a maximum for cmi. pkh -labelled evs were uptake by huvecs, and colocalized with calnexin, a protein from the endoplasmic reticulum. wound healing assays showed an increased cell migration in huvecs treated with cardiomyocyte-derived evs, in comparison with control evs isolated from foetal bovine serum. summary/conclusion: our findings suggest a different ev secretion profile along cm differentiation and maturation, with preliminary assays showing ev functionality. ongoing work aims at elucidating the possible differences in function and cargo amongst these types of evs. endothelial cells differentially load and secrete extracellular vesiclederived micrornas into apical and basolateral compartments this may play a role in microcalcification in calcific aortic valve disease (cavd), but this is poorly understood. annexin a is thought to be a marker of membrane-derived evs, but because it can be found on the cytoplasmic or extracellular side of the plasma membrane, its localization within or on the surface of evs is unclear. the goal of this study was to determine whether annexin a is found on the surface of evs in two cell lines relevant to cavd, and develop an assay that can be used to determine whether this changes under pathogenic conditions. methods: evs were isolated by differential ultracentrifugation from the conditioned medium (cm) of smooth muscle cells (smc) and valvular interstitial cells (vic). total protein in the cell lysates and ev pellets was analysed by western blot. evs from cells treated with control sirna or anxa -sirna were enumerated and phenotyped using the exoview r platform. evs with surface expression of cd , cd , cd , and annexin a were captured using a customized antibody microarray chip. then evs were labelled with fluorescent antibodies to assess ev number, size, and colocalization of ev proteins. the knockdown of annexin a allowed us to assess the specificity of the selected annexin a antibody. results: the ev fraction was positive for cd , and lacked markers of other vesicle types. western blot on the ev pellet and supernatant in ± edta indicated that there is annexin a both on the surface of and within the evs. using the antibody microarray chips, numerous annexin a + evs were captured on the annexin a spots from the control cm, and there was a marked decrease in capture and labelling from anxa -sirna treated cells. under both conditions, vesicles were also captured on tetraspanin probes, with the greatest number captured on cd , then cd and cd . there was a significant population of annexin a + evs that was negative for tetraspanins. summary/conclusion: annexin a is found on the surface of evs. the assay developed in collaboration with nanoview biosciences is well suited for assessing the number and phenotype of annexin a + evs derived from smc and vic cell lines, which could provide a useful method for understanding ev populations in cavd patient cell lines. funding: this work was supported by hl and hl . possibility of exosomal micrornas associated with chronic limb-threatening ischaemia, the end stage of atherosclerosis, as a promising biomarker introduction: chronic limb-threatening ischaemia (clti), the end stage of peripheral artery disease (pad), has poor prognosis and is attributed to lifestyle disease. with increasing of atherosclerotic disease all over the world, establishment of biomarker for should play a pivotal role for early detection and preventing aggravation of the disease. the aim of this study is to explore the possibility of liquid biopsy for atherosclerotic disease by analysis of clti-associated exosomal micrornas. methods: clti due to pad was diagnosed by anklebrachial blood pressure index, skin perfusion pressure (< mmhg) and angiography. ten preoperative clti patients and control patients without pad were analysed (all patients with diabetes and % of patients had end-stage renal failure [esrd] ). to identify biomarkers associated with clti, exosomes were extracted from patient's serum after ultracentrifugation and total rna including small rna was isolated from the exosomes. the expression profile of exosomal micrornas associated with clti were evaluated using a next generation sequencing. results: forty-three exosomal mirnas associated with clti were identified. intriguingly, these mirnas were clearly categorized with esrd, which was well known as end-stage of life-style disease: these were stratified into micrornas for esrd patients and micrornas for non-esrd patients. since esrd is the most important factor significantly related to patient's prognosis in clti, exosomal micrornas reflected patient's comorbidity onto the expression profile. summary/conclusion: a portion of the expression profile of exosomal micrornas associated with clti was identified. exosomal microrna could be a biomarker to stratify patient's condition along with their comorbidities and is very promising for individualized diagnosis in atherosclerotic diseases with risk diversity. postoperative plasma exosomal mir- and mir- a signature in patients with left ventricular reverse remodelling after surgical mitral valve repair underwent implantation of a prosthetic mitral ring. lv remodelling was assessed by cardiac magnetic resonance imaging and pexos were isolated by optimized ultracentrifugation before surgery (t ) and six months after surgery (t ). isolated pexos were quantified by nanoparticle tracking analysis and mir- , mir- , mir- a, and mir- a were measured by rt-qpcr. the same analysis was performed on healthy subjects with normal cardiac function (n = ). local ethical committee approved the study (emigrate study, approval n° ) and informed consent was obtained from all patients. results: pexos levels at t were lower (− %, p = . ) in patients with worst postoperative lv function, while they were higher at t (+ %, p = . ) in patients with reversed lv remodelling after surgery. at t , the increase in pexos levels was associated to decreased heart mass index (− %, p = . ) and higher levels of exosomal mir- (+ %, p = . ) and mir- a (+ %, p = . ) were detected in patients with improved lv function. summary/conclusion: higher postoperative levels of pexos delivering mir- and a depict lv reverse remodelling after surgical mitral valve repair. monitoring of exosomal micrornas cargo might predict postoperative outcome in patients with mr. expression of lipocalin- (lcn ) in circulating extracellular vesicles (evs) and femoral plaque-derived evs of peripheral arterial disease patients. introduction: clinically, the drug resistance situation of acinetobacter baumannii is becoming increasingly serious, and its drug resistance has become a difficult problem for nosocomial infection and clinical treatment. in view of the relatively slow development of antibacterial drugs, exploring the resistance mechanism of acinetobacter baumannii is of great significance to improve bacterial resistance and help clinical treatment. studies have shown that outer membrane vesicles (omvs) can transmit resistance genes to mediate the spread of drug resistance, and recent studies have confirmed that high expression of efflux pumps play an important role in the multidrug resistance of a. baumannii. in this study, we want to explore whether the outer membrane vesicles of acinetobacter baumannii can transfer the efflux pump related substances. methods: first, ultracentrifugation and density gradient centrifugation were used to extract the omvs of acinetobacter baumannii antimicrobial-sensitive strains (atcc ) and antimicrobial-resistant strains. then, nanoparticle tracking analysis (nta) technology was used to analyse the particle size and distribution range of omvs. transmission electron microscopy (tem) was used to identify their morphology and structure. bradford method was used to determine the protein concentration of omvs. next, the omvs of antimicrobial-resistant strains were incubated with the antimicrobial-sensitive strains and then the drug susceptibility test was done to determine whether omvs of antimicrobial-resistant strains could transmit antimicrobial-resistance information to the antimicrobial-sensitive strains. finally, pcr, qpcr and mass spectrometry were used to determine whether the efflux pump related genes were higher expression in omvs of antimicrobial-resistant strains than those in antimicrobial-sensitive strains. results: nanoparticle tracking analysis (nta) detected the concentration and size distribution of omvs of acinetobacter baumannii strains. it showed that the extracted omvs have a relatively uniform particle size and a size between - nm. tem showed that omvs had a typical vesicle structure. omvs coculture experiments showed that omvs of the antimicrobial-resistant strains can indeed pass resistance to the antimicrobial-sensitive strains. and the efflux pump related genes were higher expression in omvs of antimicrobial-resistant strains than those in antimicrobial-sensitive strains. summary/conclusion: omvs of the antimicrobialresistant strains can indeed pass resistance to the antimicrobial-sensitive strains. the cause of acquiring antimicrobial resistance in sensitive strains may be caused by resistant strains passing efflux pump-related genes or proteins to sensitive strains. characterization of melanocytic extracellular vesicles during ageing of the choroid kelly coutant a , léo piquet a , nathan schoonjans b , philippe gros-louis a , julie bérubé c , stéphanie proulx a , alain r. brisson d and solange landreville a a université laval, quebec city, canada; b université de lille, lille, france; c centre de recherche du chu de québec-université laval, quebec city, canada; d université de bordeaux, bordeaux, france introduction: the choroid is located at the backside of the light-sensitive retina and is highly vascularized. it contains pigmented melanocytes, and their melanin protects them against oxidative stress. since ageing reduces the number of melanosomes in melanocytes and generates a stiffer extracellular environment, our hypothesis is that surrounding choroidal cells and the retinal pigment epithelium (rpe) are subject to more oxidative stress-related damages. this study aimed to characterize evs released by human choroidal melanocytes in the context of intercellular cooperation during ocular ageing. methods: melanocytic evs were recovered from the conditioned culture medium of young/old melanocytes grown on hydrogels of varying stiffness ( . - kpa) by differential centrifugation. the concentration and size distribution of melanocytic evs were determined by high-sensitivity flow cytometry. cryo-transmission electron microscopy combined with receptor-specific gold labelling were used to reveal their morphology, size and phenotype. the relative abundance of surface markers was evaluated with the exo-check exosome antibody array. the uptake of fluorescent melanocytic evs by the rpe and choroidal endothelial cells was assessed by confocal microscopy. results: choroidal melanocytes released evs positive for annexin- and the tetraspanin cd . young melanocytes produced more annexin- positive evs and evs larger than nm compared to older donors. the stromal stiffness impacted the concentration and size of melanocytic evs. we confirmed the uptake of melanocytic evs by endothelial and rpe cells. summary/conclusion: evs from choroidal melanocytes are internalized by surrounding endothelial cells and rpe. age-related stressors modify the phenotype of melanocytic evs. the identification of melanocytic factors that can protect retina/choroid cells from oxidative stress-induced cell death could lead to more efficient therapy for patients suffering from dry agerelated macular degeneration. introduction: owing to their proposed biocompatibility and ability to cross biological barriers, evs represent an attractive therapeutic delivery platform. however, evs are eminently heterogeneous. a better understanding of ev heterogeneity and its origins will allow for improved design of ev-based therapeutics. ev heterogeneity is mainly studied by focusing on distinct ev subpopulations. other sources of heterogeneity, such as heterogeneity within ev secreting cells themselves, have been investigated in lesser detail. in this study, we assessed the phenotypic drift of cell derived evs to explore the origins of ev heterogeneity and its potential impact. methods: three independent samples of two mda-mb- breast cancer cell sub-clones were cultured for six weeks. evs were harvested weekly and analysed using the macsplex exosome flow cytometry kit. at two time points the proteome of evs was analysed by lc-ms/ms mass spectrometry with subsequent gene ontology and reactome pathway analysis. results: the expression of over proteins was deregulated in evs derived from the two different cell clones. many de-regulated proteins were associated with biological processes predicted to affect potential ev toxicity (platelet activation, neutrophil degranulation, blood coagulation) and ev biological activity (antigen presentation, inflammation, tgf-beta/ mtor/wnt signalling). more surprisingly, within only two weeks, over ev proteins, many associated with immune modulation, apoptosis, interleukins, cytokines and cell signalling pathways (including those affecting t-cell/b-cell receptors) were de-regulated between the two ev isolation time points. summary/conclusion: results suggest that temporal changes can be observed in the ev proteome (potentially by clonal drift, epigenetic changes or cellular genomic instability) over short time periods. these changes could cause significant differences in biological effects and delivery capabilities between evs harvested from the same cells at different time points and conditions. in vivo tracking and biodistribution analysis of mesenchymal stem cellderived extracellular vesicles in a radiation injury murine model introduction: recent studies indicated that extracellular vesicles (evs) play key roles in intercellular communication and have great potential for clinical application. understanding the biodistribution of evs is therefore essential. our previous works have shown the ability of mesenchymal stem cell (msc)derived evs to protect haematopoietic cells from radiation damage. in this study, we evaluated the biodistribution of msc-evs in a radiated mouse model. methods: human msc-evs were harvested by ultracentrifugation and labelled with did lipid dye. the reliability of the labelling evs was confirmed by sucrose gradient fractionation analysis. the distribution of evs in radiation-exposed mice after ev intravenous administration were evaluated by fluorescence molecular tomography and further confirmed by flow cytometry and confocal microscopy analysis. results: we observed that did labelled msc-evs appeared highest in liver and spleen, lower in bone marrow in tibias, femurs, and spine, and were undetectable in heart, kidney and lung. we found the significantly increased msc-ev accumulation in spleen and bone marrow post-radiation appeared with an increase of uptake of msc-ev by cd b+ and f / + cells, but not b + cells, compared to those organs from non-irradiated mice. however, there was a predominant ev accumulation in lung and less accumulation in spleen and liver; in mice infused with human lung fibroblast cell derived evs (lfc-evs) and there was no significant lfc-evs accumulation change in the spleen or liver after radiation. we further found that increasing levels of irradiation caused a selective increase in vesicle homing to marrow and spleen. this accumulation of msc-evs at the site of injured bone marrow could be detected as early as hour after msc-ev injection and was not significantly different between and hrs. post-msc-ev injection. summary/conclusion: this study indicated the specific accumulation of ms-evs at the site of injury of haematopoietic tissue in radiation injury mice. funding: this work was supported by the nih grants uh tr , uh tr - s , p gm , and t hl . linking fat to colorectal cancer: extracellular vesicle crosstalk sheffield hallam university, sheffield, uk introduction: colorectal cancer is the third most common cancer worldwide, and fourth leading cause of malignancy related mortality. understanding the mechanisms of its growth and metastasis is key to elucidating new therapeutic targets and developing treatments in the clinical setting. epidemiological evidence indicates an increased risk of cancer in obese patients, pointing to bidirectional communication between colon and adipose cells. extracellular vesicles (evs) are small membrane enclosed packages released by cells, capable of transporting bioactive cargo from donor to recipient cells and inducing phenotypic changes. adipocytes are a key component of the tumour microenvironment and interactions between adipose tissue and tumour cells may be important in the growth and metastasis of cancer. in this study, we investigate the effects of colorectal cancer evs on adipocytes in vitro, and potential induction of dedifferentiation to a more fibroblastic, pro-inflammatory phenotype. methods: evs were isolated from sw and ht human colorectal cancer cell lines by differential ultracentrifugation and mature adipocytes generated by differentiation of the sgbs human pre-adipocyte cell line. adipocytes were treated with evs and their lipid content measured by oil red o to determine loss of lipids. inflammatory cytokine profile was measured by elisa to assess any increase in pro-inflammatory behaviour, and expression of late adipogenesis markers were determined by western blot. results: ev treatment was shown to reduce lipid accumulation in adipocytes, with up to % reduction in lipids observed at the µg/ml dose. treatment was also shown to reduce the expression of late adipogenesis markers, and increase secreted levels of proinflammatory cytokines il- and il- by over fold and fold respectively. these results provide evidence for colorectal cancer derived ev involvement in the dedifferentiation observed in cancer associated adipocytes in vivo, displaying an altered phenotype, releasing lipid energy stores to fuel tumour growth and increasing pro-inflammatory signalling. summary/conclusion: studies have shown colorectal cancer evs may be involved in signalling which induces functional changes in cells within the tumour microenvironment. our work indicates that ev mediated dedifferentiation of resident adipocytes may potentially contribute to a microenvironment favouring cancer cell growth and metastasis. further work aims to elucidate the specific ev cargo which mediates these effects. introduction: ageing is a major risk factor for many human diseases. it is a complex process that progressively compromises most of the biological functions of the organisms, resulting in an increased susceptibility to disease and death. senescence is a cellular phenotype characterized by a stable cell cycle arrest. senescent cells are accumulated in the body during ageing. it contributes to develop age-related diseases and cancer. the alteration in intercellular communication with age has been demonstrated to be due to senescent cells developing a phenomenon denominated senescenceassociated secretory phenotype (sasp). exosomes are small extracellular vesicles (sev) ( - nm) of endocytic origin whereas microvesicles are formed by shedding of the plasma membrane. they contain nucleic acids, proteins and lipid that generally reflect the status of the parental cell and can influence the behaviour of neighbouring cells. methods: in this study, we demonstrated that the small extracellular vesicles (sev) contribute for transmitting paracrine senescence to proliferative cells firstly, we evaluated the presence of exosome-like particles in the sev from senescent cells by detection of exosome markers (alix, tsg and cd ), transmission electronic microscopy (tem) and nanoparticle tracking analysis (nta). to determine that sev from senescent cells are mediators of the paracrine senescence, we performed functional assays using cre-loxp reporter system and high-throughput results: besides, we confirmed at a single-cell level that the proliferative cells internalizing sev from senescent cells activate senescence process using the cre-reporter system. sev protein analysis from senescent cells by mass spectrometry (ms) and validation of top candidates using a functional sirna screen identify interferon induced transmembrane protein (ifitm ), a component of non-canonical interferon (ifn) pathway, as partially responsible for transmitting senescence to proliferative cells. summary/conclusion: in conclusion, we found that sev are regulators of paracrine senescence and ifitm contained in senescent sev has an important role in the intercellular communication mediated through sev during cellular senescence . bin wu a , lei guan a , ye xu a , likang chin a , ting li a , youhai chen a , gordon mills b , jinqi ren a , ravi radhakrishnan a , rebecca wells a and wei guo a a university of pennsylvania, philadelphia, usa; b oregon health & science university, portland, usa introduction: extracellular matrix (ecm) remodelling and stiffening are associated with solid tumour progression. stiff ecm promotes cell proliferation, epithelial-to-mesenchymal transition (emt), metastasis and chemoresistance. hepatocellular carcinoma (hcc) appears frequently in patients with liver cirrhosis or fibrosis while the mechanism remains unclear. exosomes have been determined to serve as messengers to mediate intercellular communication and influence the extracellular. tumour-derived exosomes have been shown to influence tumour progression, metastasis, drug resistance, angiogenesis and immune regulation. thus, determining whether exosomes provide a mechanism by which stiff matrix modulates tumour microenvironment for tumour progression opens a new way to understand cirrhosis and oncogenesis. here we identified the molecular mechanism of matrix stiffening induced exosome secretion and showed the different effect of exosomes induced by soft or stiff matrix on tumorigenesis. methods: huh cells were cultured on acrylamide gels with the stiffness was modulated to pa (soft) or k pa (stiff). the exosomes in conditioned media were collected and analysed by nanoparticle trafficking analysis (nta) and immunoblotting. protein expression level in cells was screened by reverse phase protein array (rppa). inhibitor or shrna were used to inhibit target proteins function. in vitro phosphorylation and gef assay were used to verify rabin phosphorylation and activation. exosomes from cells on soft or stiff matrix were injected into mice to study their effect on tumour growth. results: ( ) stiff matrix promoted exosomes secretion. ( ) akt was activated by stiff matrix and was required for exosome secretion. summary/conclusion: matrix stiffening promotes exosome secretion via akt-rabin -rab pathway, contributing to tumorigenesis. tridimensional fibroblast culture revealed a novel exososome-dependent extracellular matrix secretion mechanism vincent clément a , bastien paré b , cassandra goulet a , thiéry de serres-bérard a , stéphane bolduc a , françois berthod a and françois gros-louis a a université laval, québec, canada; b norgen biotek corp., thorold, canada introduction: the extracellular matrix (ecm) is constituted of a variety of proteins and polysaccharides that are secreted locally and assembled into a thick d meshwork to provide biophysical and biochemical support to the surrounding cells, and regulate numerous cellular functions such as adhesion, migration and proliferation. dysregulation of ecm components or aberrant ecm remodelling can lead to various pathologies, as well as to play important roles in wound healing. although ecm secretion pathways are still largely unknown, the current paradigm is that ecmassociated proteins are synthesized in the endoplasmic reticulum and transported via the endosomes to the golgi apparatus en route to the cell surface and released by exocytosis. methods: to study ecm secretion pathway, we used dimensional ( d) cultured fibroblasts. this culture method technique has been used widely to generate tissue-engineered self-assembled stromal tissues, free of exogenous materials, and rely on long-term supplementation of sodium ascorbate into the culture medium. non-cancerous fibroblasts, grown in conventional two-dimensional ( d) cellular cultures, are known to be a poor source of secreted exosomes when compared to cancerous fibroblasts. results: here, we provide evidence that non-cancerous dermal fibroblasts can secrete high amounts of exosomes, containing different ecm proteins, when cultivated in a d fashion. we also demonstrated that dermal fibroblast-derived exosomes had the capacity to travel from one cell to another, induce cellular migration and promote wound healing. summary/conclusion: altogether, these findings reveal a novel exosome-dependent ecm deposition mechanism and suggest that the use of d-fibroblast cellular culture may emerge as an innovative approach in precision medicine to better study the role of patient-derived exosomes and ecm proteins in the establishment of cellular microenvironment in health and disease. anthony yan-tang. wu a , charles lai, yun-chieh sung b , steven t. chou c , vanessa guo c , jasper c. chien c , john j. ko c , alan l. yang c , ju-chen chuang c , hsi-chien huang b , syuan wu c , meng-ru ho d , maria ericsson e , wan-wan lin f , koji ueda g , yunching chen h , chantal hoi yin cheung i and hsueh-fen juan j introduction: bionanoparticles including extracellular vesicles and exomeres (collectively termed evs), have been shown to play significant roles in diseases and therapeutic applications. however, their spatiotemporal dynamics in vivo have remained largely unresolved in detail due to the lack of a limited suitable method. methods: we developed a bioluminescence resonance energy transfer (bret)-based reporter, palmgret, to enable pan-bionanoparticle labelling ranging from exomeres (< nm) to small (< nm) and medium and large (> nm) evs and larger evs (> nm). results: palmgret emits robust, sustained signals and allows the visualization, tracking and quantification of bionanoparticles from whole-animal to nanoscopic resolutions under different imaging modalities, including bioluminescence, bret, and fluorescence. using palmgret, we show that evs released by lung metastatic hepatocellular carcinoma (hcc) exhibit lung tropism with varying distributions to other major organs in immunocompetent mice. ev proteomics identified hcc-ev lung tropic protein candidates associated with cancer progression, in which slco a and clic expression on non-tropic evs conferred lung-tropism, while cd gave spleen tropism. our results further demonstrate that redirected lung tropism decreases ev distribution to the liver, whereas the spleen tropism significantly reduces over time delivery to most major organs distribution including the liver and kidney. summary/conclusion: we established a multimodal and multi-resolution palmbret method to enable pan-bionanoparticle labelling and imaging and therefore quantification in live cells, whole animals, and preserved tissues. the method can resolve the intricate spatiotemporal dynamics of evs. palmgret revealed that evs derived from lung metastatic hcc are lung tropic, and the tropism can be conferred to non-lungtropic ev- t by decorating evs with identified hcc-ev membrane proteins. importantly, the enhanced ev delivery to tropic organs also significantly alters its distribution to other major organs. our findings suggest that the dynamics of ev biodistribution and targeted design should be investigated at the organ systems level in ev biology and therapeutic developments, respectively. tracking mesenchymal stem cell-derived extracellular vesicles (evs) in a in vivo cancer model introduction: small extracellular vesicles (sevs) are nanoparticles ( - mn) encircled by a phospholipid bilayer, derived from the endocytic pathway and released by all cells. sevs have an inherent role in cell communication and deliver cargo to target cells. mesenchymal stem cells (mscs) and have a natural ability to home to tumours and metastases while avoiding the host immune response. it is hypothesised that msc derived sevs (msc-sevs) also possess tumourhoming and immune-evading capacities therefore could provide a novel targeted delivery vehicle for treatment of cancer. it is imperative to elucidate msc-sevs migratory itinerary in vivo to support translation to the clinical setting. methods: this study aimed to image the interaction of labelled msc-sevs with cancer cells in real time in vivo. sevs were isolated from wildtype mscs and mscs with stably expressing red fluorescent protein (rfp) (via lentivirus) by the combined techniques of differential centrifugation, microfiltration and ultracentrifugation. isolated sevs were extensively characterised by transmission electron microscopy (tem), nanoparticle tracking analysis and western blot. nod scid gamma (nsg) mice with dorsal skinfold window chamber (dsfwc) were injected with either mda-mb- luciferase (luc) expressing cells or ht- -luc cells. bioluminescence imaging was performed to confirm tumour formation. a dose of x ^ msc-rfp-sevs was directly added to the window chamber and rfp expression detected using a microscope with rfp filter attachments. x ^ evs were incubated with the radionuclide, technetium- m tagged duramycin ( mtc-dur) for minutes at room temperature. excess radiolabel was removed using exosome spin column (invitrogen™). the mtc-dur-sevs were then added directly to the window chamber and charged particle imaging carried out. results: hours post-administration; the rfp signal was localised at the tumour site. radiolabelled sev signal could be detected minutes and hours after administration. msc-sevs were successfully detected at the tumour site following direct administration using two different tagging and imaging approaches. summary/conclusion: this promising preliminary data supports the potential of this approach for tracking msc-sev migration in vivo. future studies will investigate systemic tracking of msc-sev migration. vaughn garcia ; aejez sayeed ; rachel derita ; shiv ram krishn ; peter a. introduction: tumor-derived small extracellular vesicles (sevs) have emerged recently as mediators of tumorigenesis. however, the role of sevs in response to irradiation, a widely used therapy in prostate cancer, is not fully understood. methods: our study involved the tramp mouse model of prostate cancer. we used plasma sevs isolated using differential ultra-centrifugation and further isolated using iodixanol gradient fractionation. we also used nanoparticle tracking analysis (nta) to analyze sevs. mouse pelvises were irradiated using gy, for consecutive days. results: we first observed that upon pelvic irradiation of tramp mice, the levels of the signaling oncogene c-src are reduced in plasma-derived sevs, while the average size of sevs is increased from - nms to - nms. furthermore, we show that the sevs from irradiated cells lose the ability to stimulate anchorage independent growth and migration of recipient cancer cells. additionally, sevs from irradiated mice increase the amount of dna damage in recipient cancer cells. summary/conclusion: overall, our data show that irradiation of tramp mice (and prostate cancer cells) significantly reduces the pro-metastatic and pro-anchorage-independent growth potential of sevs when tested on human cells. changes to the composition and behavior of a cancer cell sev population via radiation therapy offers promise for future therapeutic approaches for prostate cancer. introduction: there are emerging physiological and pathological functions of extracellular vesicles (evs) in neurodegenerative diseases including alzheimer's disease (ad). brain derived-evs contain pathogenic proteins, such as tau, amyloid beta (aβ), which have been reported to contribute to cell-to-cell propagation in those diseases. investigation of the brain-derived ev cargo, therefore, is important to further understand the mechanisms of progression in neurodegenerative diseases. we developed the ev separation method from unfixed frozen mouse and human brain tissues and assessed the protein composition. methods: to establish the ev separation method, we separated evs from frozen mouse brain tissue using sucrose density gradient ultracentrifugation (sg-uc) or size exclusion chromatography to compare the results from the particle number, morphology and protein profiling by nta, tem and mass spectrometry. evs were then separated from cortical grey matter of ad (n = ) and control (n = ) by sg-uc. tau and aβ in the evs were measured by immunoassay. differentially expressed ev proteins were observed by quantitative proteomics employing machine learning. results: the separated evs were enriched in ev molecules and devoid of contaminant proteins by sg-uc, showing our method was successful. the levels of ps tau and aβ - were significantly increased in ad evs. annexin a (anxa ), neurosecretory protein vgf, neuronal membrane glycoprotein m -a (gpm a), and alpha-centractin (actz) were differentially expressed in ad evs. a combination of these proteins were confirmed to predict ad with the % accuracy by machine learning. summary/conclusion: these data suggest our method were suitable for the separation of brain-derived evs and ev anxa , vgf, gpm a and actz can be potential biomarkers for monitoring the progression of ad. edta stabilizes the concentrations of extracellular vesicles during blood collection introduction: to establish reliable biorepositories for research on extracellular vesicles (evs) as disease biomarkers, the release of evs during blood collection and handling must be avoided. currently, citrate is recommended as the anticoagulant for blood ev research, but citrate does not inhibit the release of evs from activated platelets. the release of platelet-derived evs excludes pneumatic tube transport and makes assays time dependent, thereby limiting clinical compatibility. therefore, we aim to stabilize the release of platelet ev concentrations. methods: blood samples were collected from healthy individuals and subjected to common circumstances known to induce platelet activation. blood was (i) incubated with or without thrombin receptor-activating peptide (trap; n = ), a potent platelet activator, (ii) send to the lab by a routine blood transport (pneumatic tube system; n = ), and (iii) stored at room temperature or at °c for hours (n = ). the concentrations of evs from platelets (cd +), activated platelets (p-selectin+), erythrocytes (cd a+), and leukocytes (cd +) were determined by flow cytometry (apogee a -micro). results: following activation by trap, concentrations of platelet-derived and activated platelet-derived evs increased . -fold and . -fold in citrate-anticoagulated blood, compared to . -fold and . -fold in edta-anticoagulated blood (edta vs citrate: p = . and p = . , respectively). preliminary data show that during pneumatic tube transport and routine sample handling, both platelet-and activated platelet-derived evs were more stable in edta compared to citrate. the concentrations of evs from erythrocytes and leukocytes were unaffected under all studied conditions. summary/conclusion: to conclude, edta stabilizes platelet ev concentrations during and after blood collection, which would facilitate pneumatic tube transport, enhance reliability and thereby improves the establishment of reliable biorepositories for ev research. introduction: cancer-cell secreted extracellular vesicles, called exosomes, are an emerging biomarker for cancer liquid biopsy. profiling of cancer-associated exosomes usually required lengthy, and multi-step procedures; therefore simple and easy-setup sensing methods are urgently needed for diagnosing cancer in a timely manner. chirality, the foundational property of all biomolecules, including exosomal proteins, can be utilized for exosome detection and differentiation using recent advances in chiral nanostructures. we found that microfluidic sensors can be successfully implemented for successful detection of cancer-associated exosomes taking advantage of unusually high circular dichroism (cd) of chiral gold nanoparticles (aunps). circular dichroism-based exosome (cdexo) detection utilizes chiroplasmonic enhancement of cd signatures of cancer-associated exosomes. we first synthesized donut-shaped aunps conjugated with l-cysteine and immobilized the aunps on a glass slide using a layer-by-layer assembly. the aunps on slide glass were surface functionalized by the standard biotin-avidin reaction after mua treatment. biotinylated annexin v marker, targeting phosphatidylserine (ps) expression on cancer-associated exosomes, was conjugated to the aunp surface. μl of exosome samples from cancer cells (a and h ) or normal cells (mrc ) were injected into the pdms microfluidic device and incubated for minutes. the cd signal before and after exosome exposure was monitored, compared, and systematically analysed as a rapid technique for the detection of exosomes with high sensitivity. results: we showed that the cdexo signals from cancer exosomes showed . folds absolute cd peak value change and . folds shift, respectively, compared to that of healthy exosomes. importantly, the cdexo sensing method takes less than mins in terms of total scanning time and requires minimal sample volumes. from the preclinical studies using blood samples from cancer patients and healthy donors, we found that cancer patients show stronger band shift and signal change comparing to that of healthy donors, implying our platform could be used for cancer diagnosis. summary/conclusion: this new versatile and sensitive method based on chiroplasmonic exosome detection paves the way to profiling disease-associated exosomes in a timely manner for minimal volumes of liquid biopsies. ev classification and fractionation strategy using surface charge labelling takanori ichiki a , hiroaki takehara a , hirofumi shiono b and hiromi kuramochi a a the university of tokyo, bunkyo, japan; b innovation center of nanomedicine, bunkyo, japan introduction: the development of new classification technology is required based on the evaluation of physicochemical properties of exosome surfaces and the diversity of constituent molecules. in this presentation, we present the electric charge activated exosome sorting platform comprising microfluidic device technology and electric charge labelling technique. methods: the single nanoparticle analysis platform, which has been developed by our research group, images rayleigh scattered light (elastically scattered light) obtained by irradiating nanoparticles with convergent laser light and provides information of individual particles by image processing. the method that utilizes electrokinetic phenomena, unlike the method using fluorescent labels, measures the properties of the particle surface without serious difficulty in principle even if the particle size is on the order of tens nanometres, and further enables to perform fractionation. since the number of particles usually handled in exosome research or its envisioned application is enormous, it is not realistic to take an approach such as a cell sorter in which particles are sequentially manipulated one by one following the measurement results of individual particles. results: particles receive attraction or repulsion by an external field according to the charge density on the surface, so there is no need to control the external force, and it is possible to design a device that can autonomously fractionate particles according to the difference in zeta potential. summary/conclusion: in conclusion, we have proposed and demonstrated the new concept of electric charge activated ev sorter. funding: this research was partially supported by the center of innovation program (coi stream) from the japan science and technology agency. high throughput exosome analysis by using reversible microfluidic electrochemical sensor system introduction: exosome is one of the important extracellular vesicles (evs) released from parental cells and it contains various types of molecular cargos from its original cell including proteins, messenger rna (mrna), and micro rna (mirnas) [ ] . the exosomes have recently emerged as biomarkers for early stage cancer detection because the number of exosomes originated from cancerous cells are significantly higher than those from normal cells [ ] . since many different types of exosomes exist in the whole blood, it is necessary to isolate and detect disease-specific exosomes. for this reason, the isolation and the detection of exosomes is an important research issue and has been studied by many groups. however, limitations such as low throughput and low recovery still make it difficult to use exosomes in diagnostics and therapeutics. methods: in this study, we developed an integrated microfluidic electrochemical biosensor to extract plasma from whole blood and subsequently detect cancer related exosomes in a continuous manner. this consists of two parts. the first part is a channel for extracting plasma containing exosomes from whole blood, and the second part is a channel combined with an electrochemical sensor for multiple detection of various exosomes in the extracted plasma. previously, a multi-orifice flow fractionation (moff) channel that consists of a series of expansion and contraction structures has been developed in our group. in this channel, the blood cells are moved to sides of channels by hydrodynamic forces and then are eliminated to outlets. at this time, the plasma is moved to the electrochemical sensor part, the exosomes in the plasma are captured to the electrodes immobilized with the specific antibodies and are quantified the amount of cancer-related exosomes. results: using this chip, blood cells were eliminated from the whole blood with over % of separation efficiency at µl/min flow rate and exosomes were collected continuously with high recovery (~ %). in order to quantify various types of exosomes, a labelfree electrochemical biosensor with electrochemical impedance spectroscopy (eis) was used for the continuous detection of exosomes. the limit of detection was x ^ exosomes/ml. summary/conclusion: the developed device is an integrated device capable of separating exosomes from whole blood with high purity and quantitating exosomes through the electrochemical sensor in a continuous manner. , , ) . the development of highthroughput techniques capable of simultaneously monitoring physical and biochemical properties of evs would significantly simplify and accelerate the characterization process. in this context, microfluidic technology is emerging as an attractive platform. here, we present a microfluidic device based on the combination of diffusion sizing and multi-wavelength fluorescence detection to simultaneously provide information on ev size, concentration and composition. methods: the diffusion of evs in the microfluidic channel provides information on their size distribution, and four different staining protocols with high signalto-noise ratios track different ev native molecules. evs are separated from unbound fluorophores directly during the microfluidic analysis, therefore avoiding the need for sample pretreatments and allowing to operate the device as a single-step immunoassay. results: the microfluidic device coupled with complementary staining techniques allows to individually detect and size particle populations with different ev components such as lipids, primary amines and the ev marker cd . we demonstrate that this approach can probe the abundance of ev-specific markers and impurities such as lipoproteins with high throughput and low sample consumption. summary/conclusion: we present a microfluidic technique capable of characterizing and quantifying evs at low costs, in a time-scale of minutes and requiring only up to µl of non-pretreated sample. this method is an important complementary tool to the current array of biophysical methods for ev characterization, in particular for high-throughput screening applications. funding: h -eu. . . -fet open programme via the grant agreement . immunomagnetic isolation of specific subpopulations of exosomes for liquid biopsy via nano-architected porous materials introduction: exosomes offer the potential to reveal significant biological information in many areas of clinical importance by virtue of their rna contents and protein surface markers. this abstract reports the fabrication of a device for high throughput targeted immunomagnetic capture of exosomes via the use of highly-ordered nano-architected porous metal lattice materials. methods: we have invented a fabrication technique to precisely make millions of nanoscale exosome sorting devices that can operate on unprocessed plasma. each nanoscale device can precisely sort targeted exosomes from background vesicles but is too slow for practical use individually. however, the operation of millions of these devices in parallel preserves the precision of nanoscale sorting while also enabling high throughput and robust use on raw plasma samples. the metal lattice within which these devices are contained is assembled via metal electroplating onto a selfassembled polystyrene bead lattice with face-centred cubic (fcc) symmetry with nanometre pores. the devices feature a conformally-coated layer of nickel-iron with gold passivation atop a base layer of nickel, resulting in a lattice of millions of nanoscale pores capable of magnetic sorting of exosomes tagged via surface-marker-based immunomagnetic labelling with magnetic nanoparticles. results: compared to our previous work on immunomagnetic exosome capture via commercial track-etched membranes (tempo), this device offers superior capture due to increased surface pore density (> x) and three-dimensional pore density (> x) alongside lower required sample volume due to decreased noncapturing volume in the device. finite-element analysis simulations show that strong magnetophoretic traps emerge at the pore boundaries in this structure between higher-permeability metals such as nickeliron permalloy and the lower-permeability sample fluid in the device. preliminary experimental data shows that this device can isolate iron nanoparticles in solution with > x enrichment from input and x capture efficacy versus tempo. summary/conclusion: current methods of exosome isolation such as ultracentrifugation and column chromatography all suffer from low throughput and limited yield. the application of inverse opal materials towards exosome capture offers the potential for isolation of specific exosome populations from very low clinical sample volumes or sparse biological signals. micropatterned growth surface topography affects extracellular vesicle production colin l. hisey a , james hearn b , yohanes nursalim a , vanessa chang a , cherie blenkiron a and lawrence w. chamley a a the university of auckland, auckland, new zealand; b university of auckland, grafton, new zealand introduction: extracellular vesicles are micro and nanoscale packages released by all cells and play an important role in cell-to-cell communication by shuttling biomolecules to nearby and distant cells. however, producing enough evs for many in vitro studies using conventional tissue culture techniques can be challenging, and despite the success of some bioreactors in increasing ev-production, it is still unknown how many independent culture conditions like growth surface topography can alter the production and content of evs. methods: standard mm petri dishes were patterned with µm tall polystyrene microtracks spaced by , and µm across a mm area using standard microfabrication techniques including photolithography, soft lithography and microtransfer printing. the micropatterns were characterized with sem and profilometry, then activated with oxygen plasma and uv sterilized. mdamb cells were seeded onto patterned and smooth (control) dishes and grown in serum-free media for the final hours of culture. evs were isolated using sequential ultracentrifugation of conditioned media and characterized using nta, tem and western blot. cell morphology was imaged using immunocytochemistry and single cell migration was characterized using time-lapse microscopy and manual single cell tracking in fiji. results: we demonstrate the simple and repeatable fabrication of microtracks across a large surface area in order to culture cells on topographically patterned growth surfaces. furthermore, we show that the µm spacing produced significantly more evs than other patterns as well as the highest cell aspect ratio and average single cell migration speed (p < . ). summary/conclusion: these findings have implications in both biomanufacturing of evs and potentially in enhancing the biomimicry of evs produced in vitro. however, further experimentation to assess the differences in cargo on patterned growth surface topographies compared to conventional methods is still required. funding: this project was funded by the maurice and phyllis paykel trust. using miscroscale thermophoresis and surface plasmon resonance to measure the interactions of extracellular vesicles mst is a quick method, easy to handle, has a low sample consumption, has no limitation on molecule size, and enables measurements in solution, either in various buffers or complex biological liquids. these properties make mst an interesting tool for research of extracellular vesicles (evs); therefore, our aim is to apply this method to evs. methods: evs were isolated from jurkat cell line by differential centrifugation. microscale thermophoresis (mst) and surface plasmon resonance (spr) were used to analyse the interaction between antibody and evs. results: we have demonstrated that interactions of evs with antibodies could be analysed by mst. however, the tiny glass capillaries for sample mounting represent a challenge due to adhesion of evs to their surface. we have tested commercial capillaries as well as prepared capillaries in house coated by liposomes or bovine serum albumin. the interactions between evs and antibodies were confirmed by surface plasmon resonance (spr), which is an established method for studying the interactions of evs. introduction: the isolation of extracellular vesicles (evs) from cell culture supernatants and complex body fluids, such as blood and urine, is of high importance for ev research as well as for future medical applications in diagnostics and therapy. nevertheless, it is still challenging to reach the desired recovery, purity and specificity due to many manual and time intensive sample preparation steps. conventional centrifugation for ev isolation or sample preparation prior to affinity-based separation methods can damage evs and cells, leading to misinterpretation of results or inactive evs. alternative field flow fractionation methods employing acoustic fields are highly promising, but so far limited to laboratory usage, based on a complex (moulding) fabrication and/or hardly reproducible. here, we present an innovative surface acoustic wave (saw)-based acoustofluidic device for gentle sorting of cells and particles. methods: our device consists of interdigital transducers patterned on a piezoelectric substrate generating saw propagating on the substrate surface. upon interaction of saw with our on-chip structured, fluid-loaden microchannels, an acoustic pressure field is developed across the fluid wherein particles are suspended. this pressure field can be employed to simply manipulate cells and particles based on their intrinsic properties, such as size, density and compressibility in continuous flow. the device is manufactured using precise and low-cost microtechnological methods and is suitable for reproducible mass fabrication. results: we demonstrated the separation of blood components, i.e. the sorting of erythrocytes and thrombocytes. furthermore, we could also show results on thrombocyte activation indicating a gentle separation without damaging these shear-sensitive cells, as well as first results on plasma separation from whole blood samples and nanoparticle sorting. summary/conclusion: our unique acoustofluidic sorting technology for complex suspensions has the potential to overcome the need for time-effective, cheap and gentle separation of evs. funding: this work was supported by efre infrapro project "champ: chip-based acoustofluidic medtech platform". nanophotonic platform for cancer-associated exosomal microrna detection introduction: exosomes have an important role in intercellular communication at physiological and pathological processes. their cargo includes micrornas (mirs), single-stranded non-coding rnas, involved in alterations on recipient cells, such as development of tumourous phenotype and metastasis. more particularly, mir- excels due to its association with several cancers. determining exosomal mirs as cancer indicators demands selective and accurate methods, which are not currently available or entail high costs. colorimetric photonic-based assays are a promising label-free alternative, which dismisses complex apparatus for signal reading since biorecognition is detected by colour change. moreover, the clinical and economic systems have also been demanding a decrease on the green footprint of biosensors, requirement fulfilled with naturally derived biomaterials. methods: herein, the biosensor is constructed on a biopolymer matrix to meet the requirements of an eco-friendly disposable device, and it is based on a photonic structure obtained by imprinting a nanopattern on the polymer surface. then, the surface is functionalized with the complementary oligonucleotide sequence of mir- as sensing probe. a labelfree detection is thus envisioned and the sensor performance is evaluated by changes in the optical properties when the target is present. results: the combination of biological materials conducted to a biosensor support with great flexibility and low water permeability, allowing easy surface functionalization. the self-reporting ability of the photonicbased sensor enables high intensity colours detected by naked eye. summary/conclusion: the alliance with the high selectivity of oligonucleotide hybridization is expected to offer great exosomal mir- recognition ability and an optimistic perspective for utilization in clinical setups. funding: the authors acknowledge the financial support from the european commission/h , through mindgap/fet-open/ga project. introduction: urinary extracellular vesicles (uevs) are important intercellular communicators. by systems biology integration, uevs prove to be relevant in genitourinary disease detection. however, it has recently been shown that labelled evs administered to the circulation can be detected in the urinary system, as well. thus, this pilot study aimed at phenotyping haematopoietic surface markers on uevs to create enough plausibility for future non-invasive biomarker studies of circulation and immune disorders that may translate into urine but are not yet timely recognized. methods: urine was obtained from healthy men signing a written informed consent (n = ). sampling was approved by the local ethics committee and in compliance with the declaration of helsinki. cell-free urine was obtained by serial centrifugation and ml, each, were utilized for the macsplex exosome kit, human (miltenyi biotec). the manufacturer's recommendations were followed to examine distinct uev surface markers of cd +/cd +/cd + vesicles in a multiplexed bead-based manner including respective controls. the accuri c (bd) was utilized for data acquisition. for further misev -compliant characterization, cd +/cd +/cd + uevs were isolated by immunoaffinity and analysed by fluorescence nanoparticle tracking (f-nta), transmission electron microscopy (tem) and western blotting (wb). urinary creatinine (ucrea) was determined to control for variances in urinary dilutions and used for data normalization. results: except cd , all other surface markers could be identified. the most abundant markers were cd and cd , which were detected in % of samples, followed by cd / ( %), cd ( %), cd and cd ( %, each). cd ( %), cd , cd ( %), cd e ( %) and cd showed similar relative median fluorescent intensities (rmfi), while cd yielded significantly higher (p = . ) and all other markers significantly lower rmfi (p < . ). tem and f-nta revealed cup-shaped vesicles ( ± nm) with . ± . e + particles/g ucrea. wb indicated uev isolates that were positive for alix, syntenin, tsg , cd , cd and cd without any uromodulin or calnexin contamination. summary/conclusion: our results imply that considerable quantities of circulatory evs are, indeed, filtered into urine and could serve as valuable non-invasive biomarkers for systemic dysfunctions. cardiovascular risk markers are strongly related to numbers of circulating extracellular vesicles ruihan zhou a , esra bozbas a , plinio ferreira b and parveen yaqoob a a university of reading, reading, uk; b imperial college london, london, uk introduction: extracellular vesicles (evs) are small plasma membrane-derived vesicles released from various cells, which potentially affect many physiological and pathophysiological processes, and are emerging as a potential novel biomarker in cardiovascular diseases (cvds). however, there is little information about the association of circulating ev levels with traditional cardiovascular risk markers and cvd risk score. methods: • subjects (n = ) aged - yrs with moderate risk of cvds were recruited and assessed for body mass index (bmi), blood pressure (bp) and plasma lipid profile (triacylglycerol, total cholesterol and high-density lipoprotein). • evs were isolated from platelet-free plasma by size exclusion chromatography and analysed by both nanoparticle tracking analysis (nta) and flow cytometry (fcm). nta was used to measure the concentration and size distribution of evs population, and evs were phenotyped by fcm via a colour panel, which included annexin v (for the majority of circulating evs), cd (for plateletderived evs) and cd (for endothelialderived evs). • the association between risk markers and ev numbers was examined by pearson's correlation coefficient and stepwise multivariate regression model. analysis of covariance (ancova) was performed after adjustment for various variables to determine the correlation between the quartile range of ev numbers and -yr cvd risk detected by qrisk . results: ev numbers, as determined by nta, were strongly associated with bmi (r = . , p < . ), blood pressure (systolic bp: r = . , p = . ; diastolic bp: r = . , p < . ) and plasma triacylglycerol levels (r = . , p < . ). plasma total cholesterol level was positively associated with platelet-derived evs, determined by fcm (r = . , p = . ). a multivariate regression model demonstrated that plasma triacylglycerol and diastolic bp independently predicted total ev numbers, with plasma triacylglycerol concentrations explaining . % of the variance for total ev numbers. an additional . % of the variance in total ev numbers was predicted by diastolic bp. ancova of the -yr cvd risk score in the quartile range of total ev numbers were positively and independently associated. summary/conclusion: bmi, blood pressure, plasma triacylglycerol and total cholesterol levels are strongly associated with ev numbers. plasma triacylglycerol and diastolic bp independently predict circulating ev numbers. elevated numbers of evs are independently associated with -yr cvd risk. introduction: extracellular vesicles from cardiospherederived cells (cdc-evs) are known to be anti-inflammatory in various disease models. to further dissect the mechanism, we examined the effects of cdc-evs on t lymphocytes. methods: naïve cd + t cells were isolated from secondary lymphoid organs of foxp -rfp reporter mice, using magnetic-activated and fluorescence-activated cell sorting. cells were subsequently polarized into effector subtypes (th , th , and th ), as well as regulatory t cells (tregs), and the effects of exposure to human-derived cdc-evs on proliferation and cytokine production were assessed. cdc-evs were isolated from serum-free, -day conditioned medium, using ultrafiltration by centrifugation. results: after polarization and culture for days, cdc-evs resulted in dose-dependent and cell-specific proliferative responses. effector t cells (th , th , th ) showed either no change in proliferation (th ) or decrease in proliferation (th , th ), compared to the vehicle control. in contrast, tregs proliferated much more than control (p < . ). next, we sought to characterize the changes in cytokine production by each effector t cell and tregs. compared to the vehicle control, exposure of polarized effector t cells to cdc-evs had little effect on the expression of characteristic cytokine genes, including ifnγ and tnfα (th ), il and il (th ), or il a and il f (th ). in contrast, exposure of tregs to cdc-evs resulted in~ -fold increase in expression of il , a key paracrine agent utilized by tregs in suppression of inflammation. this response was specific to cdc-evs insofar as it was not recapitulated with dermal fibroblast exosomes. concentrations of il- in the culture media of cdc-ev-conditioned tregs mirrored the increases in gene expression. summary/conclusion: cdc-evs potentiate tregs by increasing their proliferation and enhancing production of il- . this offers an attractive therapeutic approach to inflammatory diseases that relies on harnessing an endogenous mechanism of immunosuppression. funding: nih t hl prostanoids impair platelet reactivity, thrombus formation and platelet extracellular vesicle release in patients with pulmonary arterial hypertension aleksandra gąsecka a , marta banaszkiewicz b , rienk nieuwland c , edwin van der pol d , najat hajji e , hubert mutwil f , sylwester rogula a , wiktoria rutkowska a , szymon darocha g , grzegorz opolski a , krzysztof j. filipiak f , adam torbicki g and marcin kurzyna g introduction: prostanoids (epoprostenol, treprostinil and iloprost) induce vasodilation in advanced pulmonary arterial hypertension (pah) but also inhibit platelet activation, thereby increasing the risk of bleeding. therefore, the platelet function and extracellular vesicle (ev) concentrations were measured in pah patients treated with prostanoids and compared to patients with pah not receiving prostanoids. methods: venous blood was collected from patients treated with prostanoids (study group; n = , ± years, % female) and patients not treated with prostanoids (control group; n = , ± years, % female). platelet reactivity was analysed in whole blood by impedance aggregometry using arachidonic acid (aa; . mm), adenosine diphosphate (adp; . µm) and thrombin receptor-activating peptide (trap; µm) as agonists. in a subset of patients, concentrations of evs from platelets (cd + and cd p+; pevs), leukocytes (cd +, levs) and endothelial cells (cd +, eevs) were measured in plateletdepleted plasma by flow cytometry (a -micro). platelet-rich thrombus formation was measured using a whole blood perfusion system. results: compared to the control group, patients treated with prostanoids had lower platelet reactivity in response to aa and adp (p = . ) and lower concentrations of pevs and levs (p ≤ . ). furthermore, thrombus formation was delayed (p ≤ . ) and thrombus size was decreased (p = . ) on prostanoids. epoprostenol did not affect platelet reactivity in vitro, but decreased the concentrations of cd + pevs (p = . ). in contrast, treprostinil and iloprost decreased both platelet reactivity in response to aa and adp (p ≤ . ) and the concentrations of pevs (p ≤ . ). all prostanoids delayed thrombus formation and decreased thrombus size (p ≤ . ). summary/conclusion: patients with pah treated with prostanoids have increased risk of bleeding both due to impaired platelet aggregation, ev release and thrombus formation, compared to patients not treated with prostanoids. antiplatelet effect of prostanoids varies: whereas epoprostenol decreases the release of pevs, treprostinil and iloprost impair platelet aggregation. funding: ag is supported by the national science centre, research project preludium / /n/ nz / . evdp is supported by the netherlands organisation for scientific research -domain applied and engineering sciences (nwo-ttw), research programmes veni . nanoflow cytometry identifies an imbalance of epithelium-and neutrophil-derived extracellular vesicles in the airway environment of paediatric cystic fibrosis patients brian dobosh, vincent giacalone, milton brown, lucas silva, lokesh guglani and rabindra tirouvanziam emory university, atlanta, usa introduction: progressive lung disease is the leading cause of mortality in cystic fibrosis (cf), a chronic condition characterized by recruitment of polymorphonuclear neutrophils (pmns) into the airways. newly arrived pmns are exposed to extracellular vesicles (evs) from the airway epithelium and pmns recruited before them. in controlled experiments, these evs were necessary and sufficient to induce pathological changes including reduced bacterial killing and immunosuppressive activities towards macrophages and t-cells. however, children with cf do not always show a high pmn presence in their airways, which suggests that the balance between pmn recruitment and the activity of other cells is still in flux in early stage disease. methods: we utilized spectral nanoflow cytometry to profile the single ev content of the bronchoalveolar lavage fluid (balf) from cf children (< years of age). for nanoflow cytometry, evs were stained with di- -anepps, and with epcam, cd b and cd (to ascertain epithelial, pmn, and macrophage origins, respectively). violet side scatter and/or fluorescence threshold triggering were used for ev detection. the ratio of neutrophil-to epithelial-derived evs in cf balf correlated positively with the percentage of pmns that are present in the airways (p = . , spearman's rho = . ). this ratio also correlated with the pragma disease score, which quantifies airway damage by chest computed tomography (p = . , rho = . ). summary/conclusion: using a method to quantify evs from specific cell types in vivo, we demonstrated that the ratio of pmn-and epithelial cell-derived evs tracks with airway damage and neutrophil influx, suggesting a critical interplay between these cells in early cf disease. this ev-focused method can be applied to other diseases in which sampling cells is difficult. future experiments will use cf balf biobanks to strengthen data presented here. funding: cf foundation (tirouv a ), emory paediatrics flow core. the potential of crude extracellular vesicle micrornas for the diagnosis of community-acquired pneumonia and for the detection of pneumoniarelated sepsis as a severe secondary complication introduction: circulating cell-free micrornas (mirnas), often associated to extracellular vesicles (evs), are essential for cell-cell communication in the pathogenesis of infectious pulmonary disorders. as early pneumonia diagnosis is often clinically challenging, advances in disease detection could improve outcomes. we characterized crude ev mirnas as potential biomarkers for community-acquired pneumonia and sepsis as a severe secondary complication. methods: individuals were enrolled into our study, subdivided into a training (volunteer n = , pneumonia n = , sepsis n = ) and testing cohort (volunteer n = , pneumonia n = , sepsis n = ). after precipitating crude evs from sera (mircury exosome isolation kit-serum and plasma) and extracting total rna, small rna sequencing was performed. mirnas were selected as biomarker candidates by differential gene expression analysis (deseq ) and sparse partial-least-squares discriminant analysis (mixomics). technical and biological validation was performed by reverse transcription quantitative real-time pcr. group classification was predicted by partial-least-squares discriminant analysis. gene targets and causal networks were identified by ingenuity pathway analysis. results: differential gene expression analysis revealed significantly regulated mirnas in pneumonia compared to volunteers, and mirnas in pneumonia related to sepsis. based on sparse-partial least discriminant analysis, group separation was achieved by mirnas as discriminators with high sensitivity and specificity (area under the curve of the receiver operated curve: volunteer: . , pneumonia: . , sepsis: . ). mir- a- p (log fc = . , padj = . e- ) and mir- - p (log fc = . , padj = . e- ) differentiated between pneumonia and volunteers and mir- (log fc = − . , padj = . e- ) between pneumonia and sepsis. expression levels of mir- a- p and mir- were related to disease severity. mir- - p was higher expressed in pneumonia compared to volunteers and had equal expression in patient groups. prediction of group classification in the testing cohort was . %. signalling networks were constructed for "cellular and humoral immune response", "antimicrobial response" and "pathogen influenced signaling" involving the significantly regulated mirnas. summary/conclusion: crude ev mirnas are potentially novel biomarkers for community-acquired pneumonia and may help to identify patients at risk for progress to sepsis allowing early intervention and treatment. introduction: it remains unclear the specific mechanisms that lead to airways inflammation in asthma and the subsequent remodelling of the airways. exosomes, small extracellular vesicles, has become in an important mechanism of cell-to-cell communication and participate in diverse biological processes including inflammation. in this study, we hypothesize that exosomes and their mirna cargo play an important role in the proinflammatory status of the upper airway of asthma patients, especially in those patients with severe asthma. methods: in a pilot study, healthy subjects had induced sputum using standard methods. after several centrifugation steps, we were able to isolate exosomes from sputum supernatant by both precipitation and size exclusion cromatography (sec). exosome size was observed with transmission electron microscopy (tem) and the protein markers cd and cd were analysed by western blot (wb). then, total rnas were isolated from sputum exosomes and mirnas (mir- a-p, mir- - p, mir- a, mir- b- p, mir- - p, mir- - p, mir- - p, mir- - p, let- g- p), were evaluated by rt-qpcr. after the optimization of the methodology, healthy adults subjects and patients with persistent moderatesevere asthma, matched by age and sex were selected and induced sputum was collected. results: exosomes isolated with both methodologies (precipitation and sec) were observe under the tem with a correct range of size. furthermore, wb assay displayed a coherent protein profile for the exosome markers cd and cd . however, sec displayed low signal and the variability of between subjects was to higher. using the optimized method of precipitation, we observed that after normalization, mirna- a showed a significant increased (p = . ) in asthma patients compared to control. this mirna has been linked with an active proinflammatory status. summary/conclusion: our results confirm the presence of exosomes in induced sputum with promising applications in the field of asthma. the upregulation of exosomal mir- a, which is related with inflammation, suggest that exosomes could play a crucial role in the chronic inflammation of airway described in asthma patients. human nrf -active multipotent stromal cell exosomes reverse pathologic delay in the healing of cutaneous diabetic wounds introduction: multipotent stromal cells (mscs) have attracted much attention for their capacity to accelerate wound healing. exosomes, nanosized extracellular vesicles, may be key to translating msc therapy. we previously found that nuclear factor erythroid -related factor (nrf ) regulates msc promotion of diabetic tissue repair. here, we explore a novel role of nrf in exosome biogenesis and investigate whether exosome treatment recapitulates the effects mscs have on healing. methods: exosomes were harvested by differential ultracentrifugation of conditioned bone marrow derived msc media. for nrf -active exosomes, mscs were incubated with potent nrf activator, cddo-im. exosomes and mscs were vigorously characterized. full-thickness humanized-stented wounds were created on adult leprdb/db diabetic mice (db/db). exosomes were injected intradermally and circumferentially to the wound margin. results: mscs adopt an adherent fibroblast morphology, demonstrate robust osteogenic, chondrogenic, and adipogenic differentiation, express > % positive msc markers (cd , cd , cd , and cd ) and < % express negative markers (cd , cd , cd , cd , or hla-dr). immunoblotting of msc exosomes shows enrichment for positive exosomal markers cd , cd and tsg . nanoparticle tracking analysis (nta) shows a nanoparticle population with mean diameter of . ± . nm. transmission electron microscopy of exosomes reveals flattened cup-like spheres. nta demonstrates that nrf -active human mscs increase exosome secretion by %, compared to nrf -baseline mscs (p < . ). both nrf -baseline and nrf -active exosome treatment significantly reduced closure time to . and days respectively, compared to . days for vehicle-treated wounds (p < . ). this reduction eliminated the delay in closure time compared to wounds of c /b mice. nrf -active exosome treatment of db/db wounds reduced closure time by a further . days compared to untreated c /b wounds. at day , exosometreated db/db wounds have significant decreases in epithelial gap, expanded granulation tissue, and greater density of cd + vessels compared to vehicle-treated wounds. summary/conclusion: enhancing nrf function in mscs multiplies exosome yield. our results demonstrate exosome-based therapies hold tremendous promise and warrant further investigation for rapid translation. introduction: obesity increases prostate cancer aggressiveness and adipose tissue (at) is a rich source of extracellular vesicles (ev) that have been shown to contribute to pro-oncogenic effects in various malignancies. twist is a key mediator of tumour cell metastasis. the goal of this study was to determine molecular and phenotypic changes of prostate cancer cells in response to evs from obese human at and the role of different levels of endogenous twist . methods: ev were harvested from human at (atev) obtained from bariatric subjects or from at endothelial cells treated with proinflammatory cytokines (pic-ev) to mimic the obese at environment. evs were isolated by ultracentrifugation and characterized by electron microscopy, nta and protein markers. we determined the effect of atev and pic-ev on pc -ml prostate cancer cells proliferation and invasion. ev mirna cargo and transcriptome of pc -ml cells treated with atev or pic-ev were assessed using nanostring. to establish the contribution of twist to the ev-related phenotypic and molecular changes in recipient cells, we used pc -ml lines stably overexpressing or deficient in twist . results: atev from obese subjects and ev-pic from at endothelial cells both reduced invasion and increased proliferation in wild-type pc -ml cells. a molecular signature showing decreased expression of genes mediating invasion, adhesion and metabolism supported these functional effects. also atev and ev-pic shared a subset of mirna that target multiple mmps, inhibit glycolytic genes and target cell cycle inhibitory genes. pc -ml overexpressing twist showed an increase in both proliferation and invasiveness and this phenotype was supported by the transcriptomic analysis following ev treatment. summary/conclusion: ev produced by obese at or by at endothelial cells share a subset of mirna that in conjunction with increased twist expression contribute to tumorigenesis and metastasis of prostate cancer cells in vitro. introduction: exercise is associated with various health benefits, including the prevention and management of obesity and cardiometabolic risk factors. however, a strong heterogeneity in the adaptive response to exercise training exists. differential response to exercise training might be mediated by myokines (proteins, nucleic acids, metabolites) that can be released directly into the systemic circulation, or packaged within extracellular vesicles (evs). the objective of this study was to evaluate if changes in evs after acute aerobic exercise (ae) were associated with the responders phenotype following -week resistance exercise (re) training. methods: this is a secondary analysis of plasma samples from the exit trial (clinical trial # ). eleven sedentary obese youth ( . ± . years, bmi ≥ th percentile underwent an acute bout of ae ( % heart rate reserve, min). blood was collected before [time (at) − , min], during [at , , min], and after [ min (at ), min (at )] exercise. afterwards, youth participated in -week re programme, and were categorized into responders or non-responders (nr) based on changes in insulin sensitivity (above or below percentile). primary outcome: evs were isolated using size exclusion chromatography (izon®) at baseline (at ), immediately after ae (at ) and after recovery (at ). ev protein concentration, size, and zeta potential were analysed in a single-blind fashion. results: responders had larger evs (~ . nm) as opposed to nrs (~ . nm) at at (p < . ) and this pattern was maintained at at and at , though not significant (p = . ). nrs displayed differential ev size distribution (peaks at nm or nm), while ev distribution was highest at nm in responders. no difference in average zeta potential or total ev protein yield was observed between groups. an increase in ev yield with exercise time and recovery was observed in both groups. summary/conclusion: our preliminary data suggest that ev size is significantly increased after an acute bout of ae in obese youth responders. further research to delineate the role of evs as predictors of exercise adaptation is warranted. funding: funded by dream and research manitoba. using dual-fluorescent reporter mice to track tissue-specific extracellular vesicles andrea estrada, gabriella hehn, zackary valenti, christopher allen, nicole kruh-garcia and dan s. lark colorado state university, fort collins, usa introduction: extracellular vesicles (evs) from tissues like skeletal muscle (skm) and adipose tissue (at) have been implicated in human disease but are understudied. skm is likely a major player in ev biology as it accounts for~ % of total body mass. tools to define cellular ev origin are needed because tissues like skm are comprised of a variety of cell types. here, we describe our ongoing efforts using the dual fluorescent mg/mt mouse as a tool to analyse skm-myocyte derived evs. methods: wild-type (wt) and mg/mt mice were used for these studies. mg/mt mouse cells express membrane-tagged red (mt) or green (mg) fluorescent protein in the absence or presence of cre, respectively. we made skm myocyte mg expressing mice using a mouse expressing cre on the human skeletal actin promoter. blood was collected via cardiac puncture and platelet-free plasma was obtained via centrifugation. plasma evs were isolated using exoquick, exoquick-tc or size exclusion chromatography. skm and at were dissected into~ mm chunks, placed in serum-free dmem and incubated for hours. tissuederived evs were isolated using exoquick-tc. ev abundance was determined with a horiba viewsizer. individual evs were analysed with a cytek aurora spectral flow cytometer. settings were optimized using polystyrene beads and spectral unmixing was performed to allow detection of mg and mt. results: in wt mice, skm releases > times more evs than adipose tissue per unit of mass (p < . using paired student's t-test). since skm is also a major component of total body mass, these data further emphasize the importance of skm-derived evs. skmderived evs from wt mice were not fluorescent (< . % of events). evs from mg/mt mouse skm overwhelmingly expressed mg (> % of events) with negligible (< %) expression of mt. at-derived evs robustly expressed mt but lacked mg. summary/conclusion: these data provide "proof-ofprinciple" that mg and mt are readily incorporated into evs secreted ex vivo. surprisingly however, plasma evs from mg/mt mice expressed very little mg (~ %) or mt (~ %). this observation was confirmed with three separate isolation techniques. we are currently exploring possibilities to explain this finding, including: ) modification of evs post-secretion, ) clearance of fluorescent evs by the liver or ) that evs secreted from tissues remain predominantly in the interstitial space. funding: this work was supported by an innovative project award from the american heart association ( ipa ) to dsl. endothelial cd delivery of fa loaded extracellular vesicles is critical for thermogenesis. introduction: membrane cd facilitates tissue fatty acid (fa) uptake. we recently found that endothelial cell (ec) cd controls muscle and adipose tissue fa uptake, and influences the tissue's metabolic phenotype. the mechanism for cd -facilitated fa uptake is unknown. here we examined the role of ec cd in thermogenesis and in fa delivery to brown fat tissue. methods: adult male mice were housed individually, restricted from food during acute ( hr) cold exposure ( °c) with core temperature monitored every minutes. after hours, animals were sacrificed and samples collected for analysis. for cellular studies, human microvascular (lonza) or primary murine microvascular ec were used. for primary cells, crude cell pellets from lung homogenates were purified using mouse-cd magnetic beads (miltenyi). for microscopy studies, alkyne fa (cayman) was added to cells and to enable visualization of internalized fas, click chemistry (invitrogen) used to label alkyne-fa with alexa . for radioactive studies, primary lung ec were serum starved for hrs and incubated overnight with h-oleic acid bound to fa-free bsa ( : ratio). media was collected, clarified by centrifugation to remove microvesicles and debris. small extracellular vesicles (sevs) were isolated from clarified media using total exosome isolation reagent (invitrogen) and counted for radioactivity. results: basal core body temperatures are similar in mice lacking ec cd (eccd -/-) compared to controls (cd fl/fl). however, during cold exposure at °c , eccd -/-are unable to maintain body temperature (p < . ). plasma free fa are higher in cold exposed eccd -/-indicating fa clearance by brown fat is impaired. mitochondrial function and expression of thermogenic and mitochondrial genes in brown fat from eccd -/-and cd fl/fl mice were similar. these data suggested that endothelial delivery of fas is necessary for thermogenic maintenance of body temperature. to examine fa handling by ecs we used alkyne fas to visualize the process. we found that fas are transferred by microvascular ec through caveolae-mediated transcytosis involving src signalling and cav- phosphorylation. the internalized cav- and cd positive vesicles containing fas are released as sevs. to determine the dependence of cd on this process, we treated primary microvascular ec with radiolabeled fa and found that sevs secreted by cd -/-cells contain less labelled-fa (p = . ). summary/conclusion: endothelial delivery of fa is critical for thermogenesis. our working model for the mechanism of fa uptake by brown adipose tissue is the following: endothelial cells transfer the fa through caveolae-mediated transcytosis and secrete small extracellular vesicles (sevs) that help deliver fas to brown adipocytes. funding: this work is supported by nih grants dk and dk . introduction: diet-induced obesity modifies intestinal permeability leading to bacteria infiltration and to a decrease in the number of immune cells protecting mucosa. as orange consumption is beneficial for human health and used in preventive medicine, we determined whether orange juice-derived nanovesicles (onv) might be recommended as nutritional strategies for the treatment of intestinal complications associated with obesity. methods: onv isolated from fresh orange juices were characterized by lipidomic, metabolomic, microscopy, nta and for their stability during digestion. intestinal barrier (ib = caco- cells+ht- cells differentiated with oleic acid) were treated with onv and co-cultured with adipocytes to monitor ib fat absorption and release. obesity was induced in mice fed for weeks with a high-fat high-sucrose diet (hfhs mice vs standart chow diet mice). then half of the hfhs mice were gavaged with micrograms/day for weeks. results: onv did not modify high-fat high-sucrose diet-induced obesity and insulin resistance but reversed diet-induced gut modifications. six hours post-gavage, onv accumulated preferentially in jejunum involved in lipid absorption. in jejunum, and no other intestinal region, onv increased villi size, restored immune response and decreased barrier permeability in hfhsd mice. in addition, onv-treated mice had increased expressions of acat , angptl and dgat , but a decreased expression of fabp , fatp , mtp vs hfhsd animals, which indicated that fat absorption, tg synthesis and chylomicron release were strongly reduced. similarly to other plant-derived nanovesicles, these results were likely associated with onv lipid and metabolite compositions (strong enrichment in bioactive phospholipids: pe, pa, pc, pi and leucine) as onv did not resist to harsh digestive conditions in vitro and were poorly incorporated in enterocytes. as the effects of onv on the decrease in tg content and epithelial cell growth were also observed in vitro, gut microbiota unlikely participate to these effects. summary/conclusion: onv are important bioactive compounds of orange juice and for the first time we demonstrated that they can modulate lipid metabolism in the intestinal barrier associated with morphological changes. interestingly onv treatment targets mtp and angptl mrnas, therapeutic intestinal targets to reduce plasma lipids and for attenuating inflammation in gastrointestinal diseases. therefore, onv might be used to reduce the development of dyslipidemia-associated diseases and to restore intestinal functions in obese patients. funding: olga triballat institut; benjamin delessert institut, inrae institut. association, structure, and function of fibronectin in extracellular vesicles from hepatocytes xinlei li, ruju chen, sherri kemper and david brigstock nationwide children's hospital, columbus, usa introduction: we have shown that extracellular vesicles from normal hepatocytes have anti-fibrogenic activity and that they preferentially bind to hepatic stellate cells (hscs, the principal fibrosis-causing cell in the liver) and hepatocytes. in this study, our goal was to determine the molecular nature of the ev components involved in cell binding. fibronectin (fn ) is a key component of extracellular matrix, functioning in processes including cell adhesion, differentiation, and wound healing. two types of fn are present in vertebrates, of which the soluble plasma fn is derived principally from hepatocytes, while cell-associated fn is produced by numerous cell types. here we describe a novel function of plasma fn in facilitating binding of hepatocyte evs to target cells. methods: differential ultracentrifugation was used to collect evs released by parental mouse aml hepatocytes, fn ko aml cells in which fn was ablated using crispr-cas , primary human or mouse hepatocytes, or human hepg cells, or from human or mouse serum. evs were characterized by nanosight tracking analysis (nta), western blot, iodixanol gradient ultracentrifugation, and mass spectrometry. the binding efficiency of pkh -labelled evs from parental (ev-hep) or fn ko (ev-hepfn ko) aml cells was analysed in hepatocytes or hscs. swiss webster mice were injected with ccl for five weeks to induce liver fibrosis, with some mice also receiving i. p. administration of ev-hep or ev-hepfn ko over the last two weeks, followed by determination of hepatic fibrogenic genes by qrt-pcr. results: ev-hep or ev-hepfn ko were - nm in diameter and positive for common ev markers (cd , cd , flotillin- ). mass spectrometry showed that fn was the most abundant protein in ev-hep and comprised principally the plasma form. the abundant presence of ev fn was verified by western blot and co-immunoprecipitation with anti-cd or antiflotillin- . western blot showed that fn was also abundant in evs from primary human or mouse hepatocytes, hepg cells, and human or mouse serum. fn and ev-hep co-sedimented at a density of~ . g/ml. ev-hepfn ko yield and size-range were similar to those of ev-hep, suggesting that ev biogenesis is fn -independent. as compared to ev-hep, the binding of ev-hepfn ko to target cells was highly reduced whereas ev binding was independent of fn expression by the target cells themselves. both ev-hepfn ko and ev-hep were anti-fibrogenic in vivo but only ev-hep attenuated collagen ⍺ expression in mouse hscs in vitro. summary/conclusion: fn is abundantly associated with hepatocyte evs and facilitates ev binding to target hepatocytes or hscs. additional studies are needed to clarify the functional role of fn in mediating ev-hep anti-fibrogenic actions in vitro or in vivo. elevated glucose increases soluble and aggregated forms of human islet amyloid polypeptide in islet-derived extracellular vesicles -implications in type diabetes and islet transplantation introduction: type diabetes (t d) is characterized by reduced beta cell mass and function. islet amyloid, formed by aggregation of human islet amyloid polypeptide (hiapp), contributes to progressive beta cell loss in t d. amyloid also forms in human islets during pre-transplant culture and following transplantation in patients with type diabetes (t d) which is associated with graft failure. the cellular mechanisms underlying islet amyloid formation are still unclear. in this study, we examined the potential role of islet-derived extracellular vesicles (ev) in the clearance of soluble and aggregated (pro)iapp species from beta cells and amyloid formation. methods: human islets isolated from cadaveric pancreatic donors (n = donors) and wild-type or hiappexpressing (hiapp+) transgenic mouse islets (n = / group) were cultured in normal ( . mm) or elevated ( . mm) glucose to form amyloid. ev (exosomes) were isolated from culture medium using classical centrifugation and ultracentrifugation. purified ev were analysed by nanoparticle tracking analysis. western blot analysis and double immunogold transmission electron microscopy were performed to verify the presence of ev markers as well as (pro)hiapp species and oligomers (aggregates). results: human islets formed amyloid during culture with elevated glucose which was associated with progressive beta cell apoptosis. (pro)iapp species were detectable in ev released from human islets cultured in normal and elevated glucose. the latter markedly increased (pro)iapp content in islet-derived ev. interestingly, hiapp aggregates (oligomers) were present in the majority of ev released from human islets cultured in elevated glucose but were not detectable in islets cultured with normal glucose. similarly, ev released from hiapp+ mouse islets which formed amyloid during culture had higher (pro)iapp content compared to wild-type islet-derived ev. moreover, hiapp oligomers were present in ev derived from hiapp+ islets but not wt islets. summary/conclusion: in summary, our data show that (pro)iapp species are present in islet-derived ev and that elevated glucose increases (pro)hiapp and its aggregates in ev released from islets. islet-derived ev may play a key role in the process of amyloid formation in t d and human islet grafts. funding: university of manitoba research grants program (urgp). on. contraction, but not glycolysis, regulates the size of skeletal muscle evs secreted ex vivo. colorado state university, fort collins, usa introduction: skeletal muscle (skm) is a metabolically active tissue and accounts for~ % of total human body mass. acute exercise increases secretion of extracellular vesicles (evs), but the mechanisms responsible are unknown. muscle contraction increases the demand for atp which requires intercellular communication in order to adapt. we hypothesized that this "metabolic stress" during contraction increases skm ev secretion. methods: we tested our hypothesis using an ex vivo ev secretion assay. all studies were approved by the colorado state university institutional animal care and use committee. vastus medialis muscle (skm) from male c bl/ j mice (n = ) or female mt/mg mice (n = ) was cut into~ mg pieces and added to well plates (~ mg/well) filled with ml of serum-free dmem and placed in a cell culture incubator at c for hours. skm from male mice was treated with -deoxyglucose ( -dg) ( . nm - mm) to induce metabolic stress via inhibition of glycolysis. skm from female mice was treated with um of blebbistatin (bleb), a contraction inhibitor. after incubation, skm mass was measured and conditioned media was centrifuged ( , x g for min) to remove cell debris. evs were isolated using exoquick-tc. nta was performed on isolated evs using a horiba viewsizer . ev secretion was normalized to tissue mass and culture media volume then reported as ([particle]/ml/mg tissue). statistical comparisons for -dg experiments were made using a repeated measures -way anova. bleb experiments were analysed using a paired student's t-test. results: there was a trend towards greater ev abundance (p = . ) as a function of -dg treatment, but no effect on ev diameter (p = . ). bleb treatment did not alter ev abundance (p = . ), but significantly reduced ev mean diameter (p = . ; % decrease; dmso: . ± . vs. bleb: . ± . ). summary/conclusion: contrary to our hypothesis, inhibition of glycolysis with -dg did not stimulate skm ev secretion. however, bleb did appear to promote the release of small evs and/or inhibit secretion of larger evs. ongoing efforts are focused on testing other metabolic stressors and defining how blebbistatin promotes small ev secretion. funding: american heart association grant to dsl (ipa ). introduction: extracellular vesicles (evs, exosomes) are nanovesicles ( - nm) secreted from various types of cells. because of vesicular encapsulation of mirnas and enzymes, the evs play crucial roles in cell-to-cell communication by delivering these functional molecules to other cells [ ] . on the other hand, the evs are highly expected as next generation therapeutic tools due to pharmaceutical advantages such as controlled immunogenicity, effective usage of cell-tocell communication routes, artificial modification and encapsulation of functional molecules. however, cellular targeting and uptake efficacy of the evs are insufficient to be utilized as therapeutic tools [ , ] . in this study, we newly developed evs decorated with cellpenetrating sc or (sc ) peptides, which are derived from the c-terminal domain of the cationic antimicrobial protein, cap , because the peptides can be efficiently internalized by breast cancer cells. [ , ] . methods: all peptides were prepared by fmoc-solid phase synthesis. secreted evs from cd -gfp stably expressing hela cells were isolated by ultracentrifugation. cellular uptake of evs was analysed using a flow cytometer and a confocal laser microscope. encapsulation of saponin in the ev was conducted by electroporation. results: sc peptide is known as one of cell-penetrating peptides, and branched structure of sc peptides, (sc ) , further enhances the cellular uptake [ ] . in this research, we examined the effects of the peptide modification on cellular ev uptake, and modification of the sc or (sc ) peptides on ev membranes was conducted via stearyl moiety. as our results, increased macropinocytotic cellular uptake by modification of the peptides was successfully attained. especially, the modification of (sc ) peptides showed higher cellular uptake and macropinocytosis induction efficacy than that of sc peptides. in addition, anticancer protein, saporin toxin-encapsulated evs modified with the (sc ) peptides significantly enhanced their biological activity with dependency of glycosaminoglycan expression on targeted cells. summary/conclusion: the cell-penetrating (sc ) peptide-modified evs shows high abilities to be effectively internalized by cells and are applicable for intracellular delivery of therapeutic molecules. this study is expected to contribute to development of intracellular delivery techniques based on evs. [ introduction: rna therapeutics possess high potential which is yet to be realised, largely due to difficulties involved in delivery to the cytoplasm of target cells. extracellular vesicles (evs) possess numerous features that may help overcome this hurdle and have emerged as a promising rna delivery vehicle candidate. despite extensive research into the engineering of evs for rna delivery, little is known about how their intrinsic rna delivery efficiency compares to current synthetic rna delivery systems. using a novel crispr/cas based rna transfer fluorescent stoplight reporter system, we here compared the delivery efficiency of evs to state-of-the-art dlin-mc -dma lipid nanoparticles (lnps). methods: evs were isolated from mda-mb- cells expressing either a targeting or non-targeting control sgrna and applied to hek t stoplight+ reporter cells. lnps containing targeting sgrna were titrated onto hek t stoplight+ reporter cells to determine the minimum effective dose. lnp and ev particles were characterized using nanoparticle tracking analysis, dynamic light scattering and zeta potential analysis. sgrna copy number was determined using rt-qpcr. results: evs were ± nm in diameter as measured by dls and possessed a negative surface charge of − . ± . mv. rt-qpcr and nta analysis indicated that sgrna ev loading was low, with only in . e ± . e evs containing a single sgrna copy. nevertheless, evs containing targeting sgrna induced significant reporter activation while evs containing non-targeting sgrna did not. lnps were ± . nm in diameter and possessed a neutral charge. these particles also induced significant reporter activation when loaded with targeting sgrna. when delivered via evs, only between to sgrna copies per cell were required to induce statistically significant reporter activation. in contrast, the minimal effective sgrna dose when delivered by lnps was considerably higher at approximately e copies per cell. summary/conclusion: mda-mb- evs deliver rna in a highly efficient manner and are functional at sgrna concentrations several orders of magnitude lower than those required for lnp mediated delivery. this underlines the potential of evs as rna delivery vehicles and highlights the need to study the mechanisms by which evs achieve their efficiency in order for improved development of rna therapeutics. the role of circulating extracellular vesicles in patients with chronic chagas disease introduction: chagas disease is a neglected tropical disease (ntd) caused by the flagellated protozoan trypanosoma cruzi. it is a major public health problem in latin america, and it is now expanding over the globe through immigration of infected individuals. eukaryotic cells release extracellular vesicles (evs) that circulate in body fluids and have an important roles in intercellular communication, both in physiological and pathological conditions. objectives. our study proposes to characterize and to compare the circulating evs isolated from plasma of the chronic chagas disease (ccd) patients with healthy individuals (controls). methods: peripheral blood was collected from patients and controls in the presence of edta and evs enriched from plasma by differential ultracentrifugation. the obtained evs were characterized and quantified by nanoparticle tracking analysis (nta) and added to human thp- cells. after h, the cell supernatants were analysed by elisa for the presence of cytokines. results: lower amounts of evs were obtained from ccd patients in comparison with control individuals. however, the same amount of evs of ccd were more capable of inducing cytokines such as ifn-gamma and il- in relation to controls. summary/conclusion: although less evs are present in the blood of ccd, these evs induce high inflammatory reactions on macrophages suggesting a possible role of these evs in the establishment of chronic disease. funding: supported by fapesp, cnpq and capes. extracellular vesiclesa trojan horse for therapeutic agent delivery introduction: extracellular vesicles (evs) may prove to be one of the optimal payload carriers for therapeutic agents. while they travel through the extracellular space, the ev's lipid membrane layer shields their luminal cargo from deleterious external factors. when autologous evs are used to protect this therapeutic cargo, little immunogenic effects are expected compared to viral vectors and artificial structures, such as liposomes. their usage is potentially manifold, and they are ubiquitously present in all body tissues and fluids. the key is to develop a manageable ev loading agent for adoptive transfer therapies. methods: to exploit the unique properties of evs, highly positively charged proteins were used to load them with multiple biomolecules, such as a cas protein or dicer substrate dsrna as a functional payload and to improve their apparently inadequate natural ability to deposit cargo into the cytoplasm of recipient cells. results: highly positively charged proteins can associate with and/or diffuse through a phospholipid bilayer (thompson et al. ) . when these kinds of charged proteins are mixed with isolated evs in vitro, they are loaded into the evs. the positive charge of the protein has the advantage that it can associate with negatively charged agents, such as rna species, and aids the associated molecule to also incorporate into the ev. moreover, the positive charge of the protein helps with cargo delivery, and thus overcoming the bottleneck of the ev's cargo to escape the endosome post-uptake in a recipient cell. self-quenching fluorescent lipid dyes demonstrated that discharge of the highly positive ev cargo into the cytoplasm is concomitant with lipid mixing between the membrane of evs and the membrane of the recipient cell. when egfp-expressing microglia were exposed to evs loaded with a dicer substrate dsrna able to silence egfp via the positively charged protein, the uptake of dicer substrate dsrna was concomitant with a decrease in egfp expression in the microglia. a similar result was achieved when evs were loaded with cas protein conjugated to the highly positively charged protein. post-uptake of these cas -loaded evs, microglia expressing anti-egfp sgrna (single guide rna) lead to decreased egfp expression. summary/conclusion: our ev delivery technology has the capability of delivering multiple biomolecules, such as protein and rna cargo and demonstrates postuptake of the ev functionality of the ev delivered cargo in the recipient cell. hybrid extracellular vesiclesbiomimetic tool for drug delivery to repair endothelial cell dysfunction introduction: traditional drug delivery systems (dds) are usually based on liposomes, micelles or dendrimers. unfortunately, many dds cause side effects including organ toxicity and/or unexpected immune response. in living organisms, extracellular vesicles (evs) are responsible for delivering biologically active molecules to distant cells. in vitro loading of therapeutic compounds into evs is still not effective and needs developing new strategies. for these reasons we aimed to design hybrid extracellular vesicles (hevs) with high loading capacity for dds. methods: for hev synthesis, we used human endothelial derived evs. using freeze/thawing method we fused them with liposomes composed of cholesterol and one of the three lipids: dopc, sphingomyelin or phosphatidylserine. to confirm membrane fusion, we applied a spectroscopy ruler -fret (förster resonance energy transfer) and cryotem imaging technique. we characterized hevs using nta (for size distribution evaluation), dls (zeta potential) and western blot (for detection of evs markers). we evaluated loading efficiency using calcein as a model drug. additionally, we performed cytotoxicity tests. results: in the cryotem imaging, pure and homogenous hev population with a diameter of ± nm was detected. additionally, we observed changes in zeta potential and in size distribution after fusion. fret measurements showed increased fusion efficiency with the increasing number of freeze/thawing cycles and dependence on a lipid-to-protein ratio in evs. additionally, hev had higher loading efficiency than liposomes and sole evs and that their internalization by endothelial cells did not cause a cytotoxic effect. summary/conclusion: based on cryo-tem and fret, we confirmed that our fusion method of hybrid evs is effective and can be applied as a delivery platform for dds to endothelial cells. response to a range of stressors. the functional activity of these evs in recipient cells may, in part, be driven by changes to their biological cargoes. however, the molecular details of the underlying ev biogenesis and loading processes, and how this may vary in different conditions, is poorly understood. methods: we first studied the effect of oxidative stress on the functional activity of evs in recipient cells using cell viability and mitochondrial membrane potential assays in drosophila s r+ cells. we then carried out total rna sequencing of ev and cellular rna under three stress conditions and compared results to existing data in mouse cells. further to this we have used a bioinformatic pipeline to identify sequence motifs enriched in evs under stress. results: functional assays indicated changes to cell viability and mitochondrial membrane potential in recipient cells, which were donor cell-stress dependent. subsequent characterisation of rna showed an enrichment of ribosomal rna in evs relative to cells, but no significant changes to other biotypes. comparative analysis has also uncovered a set of genes enriched in evs under oxidative stress, and a further subset whose enrichment may be evolutionarily conserved in mouse. we also identified potential ev-loading motifs which may assist in rna loading specifically under stress. summary/conclusion: we have shown that evs derived from oxidatively stressed cells show dose-dependent differences in rna cargo and identified potential sequence motifs that may have a role in its loading. we are now validating the biological significance of these findings by combining different in vivo approaches in drosophila. this will enable us to gain insights into the basic mechanisms which govern ev loading in different contexts, and ultimately the molecular mechanisms underlying ev-mediated intercellular communication. ishai luz a , bibek bhatta a , kanaga sabapathy b and tomer cooks c a ben-gurion university of the negev, beer-sheva, israel; b national cancer centre, singapore, singapore, singapore; c ben-gurion university, beer sheva, israel introduction: mutations in tp are considered one of the most frequent genetic alterations in human cancer. besides the abrogation of the wild-type (wt) p -mediated tumour suppression, a distinct set of missense mutations was reported to endow mutant p proteins with novel activities termed gain-of-function (gof). even though mutations in tp are typically thought to arise in the tumour cells rather than in the stroma, the non-cell-autonomous effects of these mutants over the tumour microenvironment are poorly understood. in the presented studies, focusing on colon cancer as well as on lung cancer microbiome, we investigated intercellular interactions mediated by exosomes and outer membrane vesicles (omvs) in the context of cancers harbouring mutant p . methods: p results: in the colon, tumour cells harbouring mutp were found to exert a non-cell-autonomous effect over macrophages. when exposed to tumour cells harbouring mutp , monocytes became polarized towards a distinguished subset of macrophages characterized by tams-related markers. the mutant p affected tam were characterized as tnf-αlow/il- high, over expressing cd- and cd , with decreased phagocytic ability and increased invasion and matrix degradation potency. investigating the exosomal transfer from mutp tumour cells to macrophages, revealed a mutp -specific mirs signature led by mir- promoting the tam phenotype and creating an invasive front together with tumour cells. mir- was also found to be the top mutp -associated mir in a cohort of human colorectal resected tumours. separately, in two lung cancer cohorts, we identified a signature of microbiome members associated with p mutations. acidovorax temperans, a gram negative bacterium, was found to be abundant in tumours of patients with mutant p . we found a significant increase in tumour volume in animals inoculated with acidovorax temperans as compared to sham treated animals, and increased lung weight as a percent of total body weight. these preliminary data indicate that acidovorax temperans contributes to lung tumorigenesis in the presence of activated k-ras and mutant p . omvs shed by acidovorax temperans promoted inflammatory signalling in lung carcinoma cells and elevated cd expression on tumour cells and sirpα levels on macrophages. summary/conclusion: altogether, these findings are consistent with a microenvironmental role for specific "hot-spot" gof p mutants tightening the interaction between the tumour cell and the immune compartment in colon cancer. in both colon and lung cancer, mutant p facilitates cellular interactions within the tumour microenvironmets mediated by vesicles. funding: intramural funding from the national cancer institute, national institutes of health. lori zacharoff and mohamed el-naggar university of southern california, los angeles, usa introduction: the metal respiring bacterium s. oneidensis creates outer membrane extensions and outer membrane vesicles that are sculpted by the novel bar domain protein bdpa. these vesicles and extensions incorporate mutliheme cytochromes involved in extracellular electron transfer to metals and electrodes. however, the physiological relevance of incorporating these cytochromes into the higher order d architecture of a vesicle or extension is unknown. given that bar domains serve as a protein sorting mechanism in eukaryotes, we investigated the pathway crosstalk between bdpa and outer membrane multiheme cytochromes as means to understand the physiological significance of membrane architecture. methods: o this end, vesicle morphology and content was measured using dry weights, dynamic light scattering, fluorescence microscopy and comparative proteomics from wild type s. oneidensis and deletion strains. results: cells lacking bdpa make large amorphous vesicles that are dense with protein. in contrast, a strain lacking outer membrane cytochromes recruits less total protein into smaller vesicles. proteomics to show that both bdpa and multiheme cytochromes are involved in recruiting other proteins to outer membrane vesicles and have a reciprocal relationship. summary/conclusion: in the absence of bdpa, protein crowding has to become the main driving force of vesiculation and bdpa is essential for efficient incorporation of cytochromes. however, multiheme cytochromes are not only vesicular cargo, but are also important for shaping and loading vesicles. both of these situations make it clear that vesicles play a role in increasing the respiratory surface area of s. oneidensis cells. moving forward, we hope to be able to control bdpa and cytochrome levels for selective recruitment of technologically relevant payloads. introduction: fascioliasis caused by fasciola hepatica represents a major economic loss and clinical burden in cattle farming worldwide. extracellular vesicles (evs) contain pathogen-derived molecules that represent novel biomarkers of disease. in the present study, we have identified potential new biomarkers of f. hepatica infection in evs present in sera of infected cattle. methods: parasites and sera were obtained from local abattoirs (valencia, spain, and medellin, colombia, respectively). sera from infected and from healthy animals. parasites were cultured, and evs obtained by sizeexclusion chromatography (sec) and characterized by nta, tem and proteomic profiling. recombinant proteins from f. hepatica evs (enolase and fh . tegumentary protein) were produced, and coupled to magnetic beads. measurement of bovine igg antibodies was performed using luminex bead array technology. results: a total of proteins were identified associated with evs as shown by the presence of typical ev-markers (tsg , alix, cd ). two parasite proteins, enolase and the fh . tegumentary protein were produced as recombinant proteins and used for detection of cattle igg employing luminex bead array technology. interestingly, significant differences were found in the fluorescence values of both recombinant proteins allowing discrimination between sera from infected and non-infected cattle. the use of the fh . protein generated a highly significant difference between the two groups (p value = . ); as did enolase (p value was . ). summary/conclusion: this study demonstrates the usefulness of ev proteins as new biomarkers for early diagnosis of helminth infections using multiplex assays, a technology that may also be applied to other parasite ev molecules. life stage-specific glycosylation of schistosome-derived extracellular vesicles introduction: glycans play an essential role in pathogen-host interactions. larvae and adult worms from schistosoma mansoni release distinct subsets of glycoconjugates as excretory/secretory (es) products. extracellular vesicles (evs) are also among the es products. we recently found that schistosomuladerived evs are glycosylated and bind human dendritic cells via c-type lectin receptor (clr) dc-sign, leading to increased il- and il- release. here we investigated the glycosylation profile of evs released by s. mansoni adult worms, compared this to schistosomula evs, and addressed how this may affect parasite-host interactions via clrs. methods: evs from cultured s. mansoni parasites were obtained by ultracentrifugation and purified with iodixanol density gradients. isolated evs were analysed by nta and cryo em. n-glycan and lipid glycan content was determined by mass spectrometry. density gradient fractions with evs were loaded onto sds-page gels followed by western blot (wb) analysis using anti-glycan monoclonal antibodies (mabs). results: cryo em showed that adult worm evs lacked the long thin filaments that are characteristic for schistosomula evs. additionally, in contrast to schistosomula evs, glycolipids could not be detected in the adult worm evs. mass spectrometry analysis showed that the most abundant n-glycans in the adult worm evs contained galnacβ - glcnac (lacdinac, ldn) motifs, which correspond to previously published overall glycan profiles of this specific life stage. other differences in ev glycosylation between the two life stages were observed by wb using anti-glycan mabs: adult worm evs showed a paucimannosidic glycan motif whereas in the schistosomula evs galβ - (fucα - ) glcnac (lewis x) was detected in line with previous ms analysis. introduction: phloem plays a central role in plant function, as it is the responsible for the translocation of photoassimilates from source-to sink-organs, and a long-distance route for signals distribution. due to the sap high nutrient content, sieve elements are primary target for plant pathogens and pests. in this work we aimed to isolate and characterize extracellular vesicles (evs) from cucumis melo phloem sap, derived from plant either exposed or not to the melon aphid, aphis gossypii (hemiptera: aphididae). methods: phloem exudates from -week-old melon plants, either uninfested or infested with adults of a. gossypii (n = , replicates each), were collected by cutting the stem with a sterile razor blade between first and second expanded leaf from the top. evs were isolated by size exclusion chromatography, and analysed by nanoparticle tracking analysis (nta) and transmission electron microscopy. evs proteome was determined by quantitative mass spectrometry. results: evs from phloem sap were successfully isolated in every condition. no significant differences were detected among distinct samples, neither in particle concentration and size by nta, nor in protein concentration. most importantly, a total of different proteins were identified in phloem sap evs, including present in exosome databases (exocarta). on top of that, differentially expressed proteins were identified in evs derived from aphid infested or uninfested plants (p value < . ). summary/conclusion: understanding how plants trigger their defences against pests and pathogens is important to develop new control measures. the characterization of several proteins in evs from the phloem sap provide valuable information on long distance signalling in plants. moreover, as plants lack an immune system comparable to animals, the different protein content in phloem sap evs after exposure to aphids could indicate their important role in delivering inducible defences against invading pests and pathogens. extracellular vesicles from nematode species heligmosomoides bakeri and trichuris muris contain distinct small rnas that could enable niche specificity in the host introduction: gastrointestinal nematodes are extremely prevalent parasites that infect most animals and % of human population. their success as parasites is attributed to their ability to secrete diverse molecules that modulate the host immune system. extracellular vesicles (evs) are one of the immune modulatory compounds they release that directly modulate host cells. our goal is to understand how the small rna (srna) cargo underpins ev function, using a comparative analysis of ev cargo from diverse nematode species. methods: we first compared how different ev isolation methodologies (ultracentrifuge (uc), size fractionation, sucrose gradient floatation) effect the small rnas detected in h. bakeri evs using different library preparation kits (cleantag, truseq), with or without polyphosphatase treatment. we then compared this to small rna libraries from t. muris evs using comparable methods, uc ev purification, with or without polyphosphatase treatment and using the cleantag library preparation kit. results: evs from both species contained mirnas, however the mirna gene familes in h. bakeri and t. muris evs are distinct. the mirna content detected in ev samples collected by different purification protocols is robust. the largest difference in detected mirnas was found when comparing different library preparation kits. although both h. bakeri evs and t. muris evs were dominated by srnas derived from intergenic or repetitive elements in the parasite genomes, only in h. bakeri evs were these secondary sirnas. summary/conclusion: h. bakeri and t. muris evs contain distinct small rna cargos, which may underpin their ability to colonise different host niches, and/or modulate the host immune system differently. t. muris evs do not contain secondary sirnas, in contrast to h. bakeri, however they are dominated by srnas derived from intergenic or repetitive regions. comparative analysis of helminth evs could help pinpoint the srnas involved in cross-species communication. please provide any keywords if applicable.: nematode, cross-species communication, small rna introduction: extracellular vesicles (evs) are secreted from various cells including cancer cells and known to contain protein and small rnas including mirna isoforms (isomirs). therefore we also focused on isomirs including other small non-coding rnas for biomarker discovery. although liquid biopsies using small rnas are promising biomarkers for early detection of cancer, current approaches to detecting and analysing mirnas in the blood are still inadequate. artificial intelligence (ai) data analysis may provide better algorisms for diagnosing cancer. methods: small rnas were isolated from serum or purified evs using a mirneasy mini kit (qiagen) and quantified by using the ion s ™ next-generation sequencing system. (thermo fisher scientific). evs were purified using total exosome isolation reagent (invitrogen™). ai data analysis was performed using jmp® genomics and datarobot enterprise ai platform. results: three small rnas, isomir of mir- - p, mir- a- p, and trf-lys (ttt) were significantly upregulated in breast cancer patients compared with the healthy cancer-free individual. the combination algorithm using these three small rnas allows for a more accurate diagnosis of the area under the curve (auc) . . to test the possibilities that these small rnas are derived from cancer cells, we isolated evs from the serum and performed ngs analysis to profiled serum small rnas in evs. interestingly we found that two small rnas, mir- - p and mir- a- p, also high in breast cancer evs, indicating that these small rnas were expected to be derived from cancer cells. in oesophagus cancer, we also performed ngs analysis and identified twenty-four mir/isomirs candidates for diagnostic biomarkers. a multiple regression model selected mir- a- p and two isomirs (mir- - p and mir- - p) . the auc of the panel index was . . we also performed ai data analysis and discovered the novel algorisms that can diagnose breast and oesophagus cancer more accurately. summary/conclusion: we demonstrated combinations of circulating non-coding rnas containing evs potentially useful for the detection of early-stage breast and oesophagus cancers. in addition, the datarobot enterprise ai platform enables us to the more accurate diagnosis of cancers at the early stage. identification of novel ev-associated mirnas as toxic biomarkers in mouse introduction: recent findings reveal that extracellular vesicles (evs), secreted from cells, are circulating in the blood. evs are classified into exosomes ( - nm), microvesicles ( - , nm) and apoptotic bodies ( - , nm). evs contain mrnas, micrornas, and dnas and have the ability to transfer them from cell to cell. recently, especially in humans, the diagnostic accuracy of tumour cell type-specific evs as biomarkers is more than %. in addition, micrornas contained in the evs are being identified as specific biomarkers in blood for chemical-induced inflammation and organ damage. therefore, micrornas contained in the evs released into the blood from tissues and organs in response to adverse events such as chemical substances and medicine are expected to be useful as novel biomarkers for toxicity assessment. in this study, we aimed to identify target organs by comprehensive analysis of ev rnas in the blood of mice after chemical exposure to establish a highly sensitive "next generation type" toxicity test for chemical substances and medicine using ev rna in blood as a biomarker. methods: all animal studies were conducted in accordance with the helsinki declaration and the guidelines approved by the animal care committee of the national institute of health sciences. c bl/ j male mice ( weeks) were orally dosed with ccl (vehicle, , mg/kg). serum were separated from blood after , , and hours after ccl administration. the serum was centrifuged at , x g to remove cellular debris and subsequently ultracentrifuged , x g. the pellet is resuspended in pbs and ultracentrifuged , x g again. the comprehensive small rna-seq of collected evs were performed according to the manufacture's protocols. results: we succeeded in isolating more than novel small rnas, which could be used as novel highly sensitive biomarkers for hepatotoxicity due to carbon tetrachloride (ccl : mg/kg & mg/ kg). well known hepatotoxicity biomarkers, mirna- and mirna- were upregulated more than -fold in the administration of mg/kg ccl , but not responded in the administration of mg/kg ccl . summary/conclusion: these results suggest that mir- and mir- are mainly released from liver to blood directly only in the administration of mg/kg ccl , while novel more sensitive hepatotoxicity biomarkers which responded in the administration of both mg/kg and mg/kg ccl should be included in the ev. our novel biomarkers will accelerate a rapid evaluation of chemical substances and medicine in nonclinical safety evaluation. introduction: advancements in sequencing technologies have allowed analysis of the genomic landscape of cancer using circulating cell-free(cf) dna. however, cfdna does not originate only from tumour cells. we recently demonstrated that most of the dna circulating in plasma of cancer patients is associated with large evs (l-evs), and that l-ev-associated dna reflects genomic aberrations of the cells from which l-evs arise. since l-evs are specifically released by tumour cells, we explore their potential to report cancer-specific genomic alterations in patient plasma and compare it to cfdna. methods: differential ultracentrifugation, tunable resistive pulse sensing, qubit dsdna high sensitivity assay, capillary electrophoresis, whole exome sequencing ( - x), targeted sequencing (qiaseqtm), flow cytometry. results: we show here that l-evs in the size range of > micrometre are present exclusively in plasma obtained from cancer patients and absent in plasma from healthy donors. in agreement with this finding, double-stranded(ds) dna is detected only in l-ev fractions of patient plasma and not in those obtained from healthy donor plasma using the same protocol. we also demonstrate that the fragments of dsdna associated with circulating l-ev are larger in comparison with cfdna (> , bp versus~ bp). a large-scale analysis of l-ev dna obtained from plasma of patients with metastatic castration-resistant prostate cancer (mcrpc) as well as with non-small cell lung cancer (nsclc) demonstrates that dna associated with circulating l-evs reports cancer-specific genomic alterations in both types of cancer. we further investigate if l-evassociated dna is intra-or extravesicular and demonstrate that it is present in both forms. we finally compare the purity of the tumour signal in intravesicular l-ev dna, total l-ev dna, and cfdna obtained from patient plasma. summary/conclusion: our results demonstrate that circulating l-evs contain high quality, large molecular weight dna that contains cancer-specific genomic alterations, supporting the use of l-evs as a source of tumour-derived dna in plasma. introduction: epidermal growth factor receptor (egfr) mutation driven lung adenocarcinoma (ac) represents a unique subgroup that lends itself to treatment with oral egfr tyrosine kinase inhibitors. current methods that are used to detect these mutations (e.g. l r or the resistance mutation t m) involve invasive tumour biopsies or blood circulating tumour dna (ctdna) and cell free dna (cfdna). the sensitivity of blood ctdna and cfdna is limited by the frequency of genomic alterations in the egfr gene; additionally, ctdna does not reflect changes in the egfr protein, against which novel therapies are in development. there remains a need to develop bloodbased biomarkers that can circumvent these disadvantages and replace the more standard, invasive tumour biopsies. we propose the study of exosomes for treatment monitoring as well as to identify egfr resistance related genomic and proteomic changes. methods: we enrolled patients with metastatic lung ac: with egfr mutations and without (control). from the patients with egfr mutant lung ac, we processed blood samples through the patients' treatment course, using ultracentrifugation to isolate exosomes. we then used both droplet digital pcr (ddpcr) to test exosomal rna (exorna) for the mutation of interest and western blots to test protein resulting from exon deletion or l r mutations. results: from patients with egfr exon deletion mutations, we detected identical mutations in exorna from / samples. exorna based mutational load increased and mirrored clinical progression in patients. three patients whose cancer remained stable demonstrated a decrease in their exorna. one patient had blood drawn only at points and was therefore not plotted. exorna from patients with l r and t m mutations demonstrated the corresponding mutations; however, exorna did not mirror their disease course. we also demonstrated mutant egfr protein presence in exosomes from patients. finally, we tested cfdna for egfr mutations from four matched samples using ddpcr. we detected matched mutations in exosomes in all four, while cfdna mutations were only detected in / patients. summary/conclusion: in summary, we detected egfr mutations in / exosome samples isolated from metastatic lung ac. our results set the stage for optimization of exorna methods and inform future experiments relating to exosomal cargo in patients with egfr mutant lung ac. identification of plasma-derived, ev-based biomarkers for glioblastoma introduction: glioblastoma multiforme (gbm) is the most malignant and aggressive primary brain cancer in adults, with an incidence of . per , people. currently, diagnosis is only performed via histopathological investigation of a tissue sample from a gbm lesion, complemented with molecular diagnostics for identification of select biomarkers. mri is the standard of care for follow-up and monitoring of treatment response. therefore, development of a "liquid biopsy" to obtain disease-relevant information from patient's body fluids is highly desirable. methods: we present the results from a clinical study in which extracellular vesicle (ev)-derived mrnas and long non-coding rnas were profiled from the plasma of gbm patients and control individuals. we obtained plasma from patients at the time of initial diagnosis, and matched controls by sex and age. ev-associated rna was isolated from - ml plasma and rna-seq was performed using our proprietary pipeline. sequencing data was analysed for differential gene expression. results: we observed mrnas as differentially abundant between gbm and control samples, with mrnas enriched in gbm samples and mrnas enriched in control samples (p < . ). correlation based on differentially abundant mrnas separated gbm and control samples into two unique populations. eight differentially expressed mrnas were previously identified as part of the mesenchymal gbm subtype. these data, while preliminary, provide a potential basis for the further development of a noninvasive gbm gene panel test. summary/conclusion: we have identified a novel rna signature for gbm from plasma derived evs, which differs from previously identified biomarkers isolated from tissue. further work will refine this signature to enable detection, characterization, and patient monitoring for gbm with minimally invasive techniques. introduction: sjogren's syndrome (ss) is a systemic autoimmune disease in which inflammation progressively damages the moisture producing glands of the afflicted. million americans are estimated to be suffering from the disease, % of which are women with an average age of . overlapping symptoms with other health conditions and co-morbidities make ss particularly difficult to diagnose, with average time to diagnosis of years. saliva exosomal rna profiling has been primarily focused on small rnas and has been limited thus far due to the large contribution of sequencing reads from the oral microbiome. a noninvasive saliva exosomal rna (exorna) based test capable of diagnosis would be highly desirable. methods: we began by first developing a novel long rna-seq workflow to selectively enrich and profile human exosomal mrnas and long non-coding rnas (lncrnas) from saliva. we then profiled salivary exorna obtained from ss patients and healthy matched controls. finally, we performed differential gene expression analysis to obtain an exorna signature for ss. results: rna-seq data analysis demonstrated highly efficient enrichment of human transcriptome, with over % of reads mapping to the transcriptome. further rna biotype analysis showed over % of transcriptome reads mapped to protein coding genes and lncrnas. we detected over , mrnas and approx. lncrnas. differential expression analysis (dex) of ss vs. healthy control exorna identified upregulated genes, including mrnas and lncrnas (p < . ). genes were found to be downregulated in ss, including mrnas and lncrnas. gene ontology analysis of dex genes revealed enrichment of genes involved in various immune system related pathways. most importantly, principal component analysis (pca) resulted in clear separation of ss patients from healthy controls. summary/conclusion: our optimized rna-seq workflow enables saliva-based liquid biopsy for biomarker discovery. the gene signature identified in this ongoing study could potentially provide a non-invasive molecular means of diagnosing sjogren's syndrome. introduction: increasing embryo implantation rates has become one of the greatest challenges in assisted reproduction techniques. usually an endometrial biopsy is done to identify a receptive endometrium, which prevents embryo transfer in the same cycle, as it is detrimental for the implantation. the implantation is a complex process, which requires a synchrony between the development of the embryo and the endometrium, but also, an adequate embryo-endometrial cross talk. the presence of extracellular vesicles (evs) as mediators of this communication has been describe in the endometrial fluid. therefore, we hypothesize that the molecular analysis of the content of the evs and companion molecules from endometrial fluid could be a non-invasive method to recognize an implantative endometrium and consequently improve the implantation rates. methods: the objective is to define a simple, sensitive and reproducible non-invasive ev-based method that allow the quick identification of an implantative endometrium by means of mirna analysis. for the establishment of a robust methodology for analysing evs from endometrial fluid in clinical settings, where the sample is limited and no sophisticated equipment is available, five different methodologies were compared in triplicate. two of them consisted in the direct extraction of rna while in the other three, before the rna extraction an enrichment of evs was done. smallrnaseq was performed to determine the most efficient method. once the best method was selected, it was applied in a set of real samples with different implantation outcome. the content of mirnas (mainly associated with evs) of endometrial fluid samples from women in whom the implantation was successful (n = ) and unsuccessful (n = ) were analysed. results: our results show that the protocols with a previous enrichment step of evs obtained a higher mirna expression. the results obtained from the differential analysis of the set of samples with different implantation outcome are being analysed and it is expected that the results will be available by the time this communication is presented. summary/conclusion: this work demonstrates that it is possible to obtain and analyse evs and evs-associated mirnas from a small volume of endometrial fluid samples, which allows the use of ev-mirnas as a low-invasive biomarkers for the detection of an implantative endometrium. funding: jip is supported by a predoctoral grant from the basque government. small rna cargo of evs is affected by hormone treatment in prostate cancer introduction: small rnas are recently reported as a regulator for prostate cancer progression to castration-resistant disease. our previous work has shown that evs protein cargo is affected by male steroid hormone, dihydrotestosterone (dht). in this study, we assess the small rna cargo of evs in response to androgen manipulations. methods: androgen receptor-positive lncaps are grown in css medium to deplete the androgens. media were then replaced with vesicle-depleted css medium ± nm dihydrotestosterone (dht) ± µm enzalutamide (enz) for h. evs were isolated using sequential ultracentrifugation ( g for min, , g for min, , g for h), washed once in pbs. protein and rna were collected from both parent cells and conditioned medium to allow direct comparison between s-evs cargo and cells. small rna ngs libraries were prepared using the illumina's truseq small rna library prep kit and single-end sequenced at a read length of nucleotides (nt). fastq library files were processed using a custom-designed pipeline. adapters were removed using the cutadapt tool, trimmed reads were mapped with high stringency against ribosomal sequences using bowtie . snorna and trna fragments were identified using the flaimapper software. remaining reads were mapped against the human genome hg using bowtie . results: we found that the presence or absence of androgens does not significantly change the amount of total rna in small evs (s-evs). however, hormone stimulation altered the small rna content of s-evs, in parallel with our previous published data on ev protein cargo. dht increased the abundance of snorna in cells, while a reduction of snornas was observed in the s-evs fraction. interestingly, dht induced the formation of cell filopodia that are not inhibited by androgen inhibitor enzalutamide. pathway analysis indicates the p mediated regulation driven by mirnas found in s-evs upon exposure to dht. the expression profile of snorna and trna fragments in dht treated cells resembles results from clinical prostate cancer specimens. summary/conclusion: our findings show that androgen manipulation alters both s-ev derived protein and rna cargo. changes in the s-ev rna profile due to treatment with androgens are not identical to small rna profiles in parental cells, indicating a specific sorting mechanism of s-ev small rna upon androgen manipulation. further, dht induces the formation of cell filopodia irrespective of enzalutamide, suggesting cargo selection of s-evs. we conclude that small rna ev cargo can be utilised to as prostate cancer biomarkers in androgen targeted treatments. introduction: cancer immunotherapy, such as pd-l blockade, is a method to eliminate cancer cells. ectopic expression of pd-l , on the surface of tumour cells, has been associated with tumour persistence and as an important predictor of therapy response. a test that, specifically and accurately, detects pd-l is critically important in order to identify patients that would benefit from these treatments. emerging evidence has shown that extracellular vesicles (ev) can carry immune checkpoint molecules, such as pd-l , and whose expression have been correlated with tumour immunity response. with a multitude of commercially available antibodies identifying appropriate clones and associated assay is important in order to standardize the diagnostic modality used. methods: pd-l expressing cancer cell lines were used to generate evs. pd-l -myc vector was transfected to generate an overexpression system. exoview® sensors containing different anti-pd-l clones were generated. samples (cell derived and plasma) were incubated on chips to allow the antibody to bind the antigen on the ev. after incubation, chips were immunolabeled with fluorescently labelled antibodies against pdl- or ev associated markers. exoview r reader was used to enumerate the evs captured on the sensor surface and analyse the expression of pdl- on single vesicle through fluorescence imaging. immunoprecipitation and mass spectrometry (ip/ms) were employed as an orthogonal method to verify the specificity of the assay. results: to study the detection efficiency of the antibodies, engineered pd-l -myc evs were used. under these circumstances, all the tested antibodies were able to capture evs. when testing endogenous pd-l positive evs from different cancer cell lines, only . and clones consistently bound to evs. in addition, evs derived from plasma demonstrated to be positive for pd-l , however, only clone . was able to immobilize these evs. the results suggested that clone . could be a potential pd-l antibody to detect pd-l positive evs originating from various sources. to confirm these results, and assure the specificity of the antibody targeted ip/ms was employed. summary/conclusion: in combination with the exoview platform, anti-pd-l antibodies can be screened and potentially used to generate a non-invasive ev-specific assay that could detect this protein in patients. differences in extracellular vesicle protein cargo is dependent on head and neck squamous cell carcinoma cell of origin university of michigan, ann arbour, usa introduction: head and neck squamous cell carcinoma (hnscc) is the sixth most common, eighth most fatal cancer worldwide and includes cancers of the oropharynx, larynx, hypopharynx, and oral cavity. in , there were over , new cases and , deaths estimated in the usa alone. despite recent advances in treatment, including radiation, chemotherapy, surgery, concurrent chemoradiation, and immunotherapy, many tumours develop resistance and progress. patients develop metastases or tumours recur locally or regionally; the -year overall survival rate for hnscc is only - %. factors that contribute to poor survival for patients with hnscc include late stage diagnosis, lack of reliable markers for early stage detection, high level of biologic heterogeneity, and local recurrence and distant metastases after treatment. methods: this study used representative hpv-positive and hpv-negative hnscc cell lines, one hpvtransformed cell line. and two non-cancer oral keratinocyte cell lines. evs were isolated using differential ultracentrifugation and peg precipitation/ultracentrifugation. evs were characterized by tem, nta, and wes protein analysis for reported ev markers. ev and whole cell lysates were assessed by lc-ms/ms analysis using the tandem mass tag- plex kit. cluster analysis was performed on the fold-change peptide spectrum matches (psm) for the evs from the hnscc lines compared to the evs from the normal keratinocyte line (noksi). protein was measured using a capillarybased electrophoresis instrument. results: cd and annexinv were detected in all of the ev lysates tested, while calnexin was detected in all of the whole cell lysates and none of the ev samples tested. selected proteins stat , hla-a, tenascin, e-cadherin, β catenin, cytokeratin , epha , and cd , and hpv-related markers p , p , rb, cyclin d , and egfr were tested using the wes platform. evs from hpv-positive cell lines showed higher protein levels compared to evs from hpv-negative cell lines in stat , hla-a, and tenascin. only kert demonstrated lower protein levels in evs from hpvnegative cell lines. of the common hpv-associated hnscc markers: egfr, p , rb, cyclin d and p , only egfr was positive in any the evs tested. the remaining proteins queried, e-cadherin, β catenin, epha and cd showed varying protein levels in evs from both hpv positive and hpv-negative cell lines. summary/conclusion: our findings suggest that these proteins may be potential hnscc ev markers that may be ) selectively included in ev cargo for export from the cell as a strategy for metastasis, tumour cell survival, or modification of tumour microenvironment, or ) representative of originating cell composition, which may be developed for diagnostic or prognostic use in clinical liquid biopsy applications. validation of antibodies on western blot for extracellular vesicles from biological human samples and cancer cell conditioned media the brady urological institute, johns hopkins university school of medicine, baltimore, usa introduction: one of the major challenges in extracellular vesicles (evs) research is to prove the particles that are isolated are true evs, rather than other co-isolated contaminants, like lipoproteins. isev recommends using multiple assays to characterize evs. this study aims to validate the positive and negative protein markers for extracellular vesicles from plasma, urine and prostate cancer cell conditioned media (ccm). methods: membrane and cytosolic fractions of mcf cells served as positive and negative controls for all antibodies validated. evs were isolated from plasma of healthy volunteers, urine of healthy volunteers and ccm of pc- cells using differential ultracentrifugation. eight protein markers were assessed: positive markers cd , cd , cd , flotillin (flot ), alix and tumour susceptibility gene (tsg ), negative marker calnexin (canx), and contaminant markers apo-a for plasma and thp for urine. tetraspanins are small transmembrane proteins expressed in evs. flot is membrane protein that forms microdomains in the plasma. alix and tsg , an accessory protein of the endosomal sorting complex required for transport, are involved in the biogenesis of evs. they are positive markers for evs. canx is in the membrane of the endoplasmic reticulum. apolipoprotein-a (apo-a ) is the protein components of lipoproteins, therefore it is marker of contamination for plasma ev. tamm-horsfall protein (thp) is contamination marker for urine ev, because it is most abundant protein in human urine. results: all antibodies were validated in the correct positive and negative control, thus confirmed as usable and reliable antibodies for western blot. in plasma ev, cd , cd , cd and flot were positive and canx and apo-a were negative. in urine evs, cd , cd , flot- , alix and tsg were positive and canx and thp were negative. in ccm evs, cd , cd , flot , alix and tsg were positive and canx was negative. summary/conclusion: we confirmed a high degree of ev purity from sample types: urine, plasma, and ccm. of particular importance, we confirmed that evs isolated from biologic patient samples, plasma and urine, had low contamination. future work will use these methods to confirm purity of ev samples prior to addition analysis, such as examining ev cargo and biologic significance. proteomic study of mesenchymal stem cells derived exosomes modified using mir. introduction: the project we are working on is to modify the immunogenic profile of human cmms from the umbilical cord stroma through its stable transfection with anti-mir- - p, and therefore of the exosomes that these cells generate, for use in free-cell therapy to treat inflammatory process. methods: evs released from a primary culture of human umbilical cord mesenchymal stem cells and from primary culture of human umbilical cord mesenchymal stem cells mir -/-modified through stable lentiviral transfection were isolated by ultracentrifugation processes, characterized by transmission electron microscopy (tem) and measured by nanoparticles tracking analysis (nta). protein extraction from evs was made using ripa buffer and after checking protein integrity the total ev proteins. we performed a shotgun proteomic study using a tmt ( -plex) label of the total mir -/-exosomes protein comparing it with normal exosomes. after labelling the ltq-orbitrap platform of proteored was needed for fraction injections and data acquisition. proteome discoverer . (thermo) was used for protein processing and quantification. results: a total of . proteins were identified at least with a unique peptide and we have able to establish the proteomic profile of mir -/-exosomes against normal exosomes. we found out several protein modulated by mir and related to inflammation. summary/conclusion: we have able to establish the proteomic profile of mir -/-exosomes against normal exosomes focusing on proteins involving inflammation process. all those results seem indicate that exosomes could be modified, which could be used as an anti-inflammatory free-cell therapy. funding: proteored concept test project grant. a novel extracellular vesicle isolation method used to discover urine liver disease biomarkers introduction: hepatocellular carcinoma (hcc) is the th most common cancer worldwide and the rd most common cause of cancer death; additionally, its incidence is increasing. while outcomes for early hcc are superior to those for late stage disease, early detection of hcc remains a challenge. current guidelines have suboptimal sensitivity and specificity. in this pilot study, we hypothesize that urine extracellular vesicles (evs) may identify candidate biomarkers towards the development of an inexpensive, widely accessible screening assay for the early detection of hcc. methods: urine samples from healthy subjects, subjects with cirrhosis, and subjects with cirrhosis plus hcc were collected and processed using ymatrix columns to isolate ev-associated protein and mirna. protein was analysed using a tandem mass tag method on a thermo scientific orbitrap fusion mass spectrometer with comet/paws and edger processing. mirna was analysed using a targeted firefly microarray from abcam. differential expression and predictive modelling for the presence of hcc and cirrhosis was performed to identify candidate mirna and protein biomarkers. results: for mirna, samples were eligible for analysis after low expression filtering. we used pair-wise ratios of cancer-associated mirnas by gradient boosting of decision trees to develop a predictive model for hcc. our best model had a sensitivity and specificity of . and . respectively using mirnas to distinguish hcc from cirrhosis. all samples were eligible for protein analysis. based on differential expression and biologic relevance, we identified protein candidate biomarkers. interestingly, we found liver-selective proteins and known hcc/cirrhosis plasma/tissue markers, demonstrating proof-of-concept for the method. summary/conclusion: urine extracellular vesicles contain liver-selective proteins and known liver disease serum biomarkers as well as novel mirna and protein biomarkers that are significantly up-regulated in disease samples. the described candidate biomolecules may be easily accessible biomarkers with which to develop a sensitive and specific universal screening diagnostic for the early detection of cirrhosis and hcc. introduction: the peptidergic g-protein coupled receptors (gpcrs) are cell-signalling transmembrane proteins, which in their native form comprise of seven segments embedded in the cell membrane. this structural advancement is believed to be maintained in extracellular vesicles (evs). in autoimmune diseases, the presence of autoantibodies towards gpcrs is not uncommon, and to detect plasma autoantibodies, evs carrying gpcr will be used as template in a novel microarray screening tool. methods: purified evs from hek cells were printed on different types of surfaces; polymer coated glass slides and hydrophilic and hydrophobic plastic well plates. five different print buffers were tested in a multiplex assays. spots containing evs were stained with biotinylated antibodies (cd , cd , cd , adrβ , hsp , epcam and flotilin- ) followed by binding of cy -labelled streptavidin and visualized microarray scanner. results: the outcome of these experiments was promising, as some of the chosen printing buffers showed increased tendencies to bind evs. the ev presence was verified with a panel of markers known to be present on small evs. in addition, the ev content of the adrenergic beta- receptor (adrβ -receptor), which is a gpcr of interest in autoimmune diseases, was verified in some of the experimental setups. summary/conclusion: the approach of using evs as template in a screening tool possesses the potential to easily screen for autoimmune illness markers in diagnostic purposes. using the microarray technology allows the screening to be multivariate, specific and highly sensitive. circadian variation of extracellular vesicles secreted in urine: analysis of time point collection and normalization strategy. introduction: urinary extracellular vesicles (uevs) are an ideal source of biomarkers for kidney and urogenital diseases. despite the great deal of interest generated by uevs, little is known about its collection time and normalization approach. the majority of the studies on uevs focus on spot urine collection based on the assumption that it accurately reflects the renal function, although time point of collection is not standardized. therefore the practice to collect spot urine does not allow for calculating and standardizing accurately the uev excretion rate which may vary during the day. in addition, no research has been carried out yet to show the quantitative and qualitative difference of uevs between spot urine and h collections.the aim of this study is to compare uevs excreted in all single voids during a hour collection period and compare it with hour collection performed. methods: uevs were enriched by differential centrifugation and electron microscopy, western blot, nanoparticle tracking analysis, tuneable resistive pulse sensing and imaging flow cytometry were used to quantify uevs and associated markers variation during the hour. creatinine, urine osmolality and particle concentration were used to normalize the assessed analytes. results: electron microscopy showed a heterogeneous population of evs and western blot confirmed the presence of ev markers (tsg , alix and cd ). rna was extracted by a column-based method (mirna extraction kit qiagen) and cel- mirna was spiked in each sample. a multiparametric detection of nephron markers podocalyxin, aquaporin- and uevs pan tetraspanins (cd + dc + cd ) was performed utilizing imaging flow cytometry. whereas the uev composition did not change across the hours analysis, the quantity of uevs and related markers fluctuated during the day depending on the hydration and excretion rate.the results of a hour urine collection reflected the average results of all single voids over a hr period. creatinine and particle count normalization failed to normalize "outliers". summary/conclusion: this study represents the very first report which compares single void urine versus hour uev analysis. we concluded that the hour collection is the preferred choice for a robust and rigorous assessment of uevs and its associated markers. porcine body fluids differ in small extracellular vesicle counts: comparison of blood plasma, seminal plasma and cerebrospinal fluid as vesicle sources for proteomic analyses helena kupcova skalnikova a , jakub cervenka b , jaromir novak a , karolina turnovcova c , bozena levinska a , jana juhasova a , stefan juhas a and petr vodicka a a institute of animal physiology and genetics, czech academy of sciences, libechov, czech republic; b institute of animal physiology and genetics cas, v. v. i. libechov, libechov, czech republic; c analysis tools were used to identify in silico biological pathways and functions governed by detected mirnas. expression of putative targets of selected mirnas was tested using qpcr after in vitro delivery of uterine evs to ptr cells. results: careful characterisation confirmed that uterine lumen is enriched with a diverse population of evs caring mirnas. interestingly, out of detected mirnas showed difference in abundance between tested days of pregnancy and half of them was exclusively detected on d . identified mirnas were characterized as potent regulators of cellular development, growth, proliferation, and movement, in addition to their involvement in organismal and embryonic development. the expression of genes identified as a possible mirna targets was tested after evs delivery to ptr cells in vitro. both down-(e.g., ptger ) and up-regulated (e.g., lifr) genes were found (p < . ); involved in the same molecular and cellular functions enriched by detected mirnas. methods: evs were harvested from wild type and arrdc -/-epididymal cells using differential ultracentrifugation, then characterised using nanoparticle tracking analysis and transmission electron microscopy. sperm motility was measured using computer assisted sperm analysis and imagej. fertilisation capacity was measured using the following assays: capacitation-associated tyrosine phosphorylation, calcium ionophore induced acrosome reaction, zona pellucida binding assay and in vitro fertilization with time-lapse imaging of embryo development. immunohistochemistry was also used to visualise two pronuclei formation and blastocyst morphology. arrdc -/-sperm was supplemented with wild type evs in the above assays to assess whether they could restore function. results: sperm from arrdc -/-mice develop normally through the testis but fail to acquire adequate motility and fertilization capabilities through the epididymis, as evidenced by reduced motility, premature acrosome reaction, reduction in zona pellucida binding and production of two-cell embryos. we observed a significant reduction in ev production by arrdc -/-epididymal epithelial cells, and addition of wild type evs to arrdc -/-sperm dampens the acrosome reaction and restores zona pellucida binding. introduction: gestational diabetes (gdm) is among the most common pregnancy complications. despite treatment, up to % of pregnancies complicated by gdm result in infants being born large-for-gestational-age (lga). this not only causes problems at birth but predisposes offspring to developing cardio-metabolic disease in adulthood. there are no treatments for lga as the cause is unclear, although it is associated with altered placental vascular development. micrornas (mirnas) regulate placental development; they are produced within cells but can be released into the circulation inside evs, which in turn can be transported into target cells and tissues to influence cellular processes. we aimed to characterise circulating evs in pregnancies complicated by gdm-lga and determine if ev-derived mirnas have the potential to influence placental development. methods: maternal serum and plasma samples were collected from women with pregnancies complicated by gdm at - weeks gestation; placental tissue was collected at delivery and birth outcomes recorded. serum and plasma evs were isolated and characterised by electron microscopy (shape), nanoparticle tracking analysis (nta; size/concentration), and western blotting (ev-enriched proteins). mirna qpcr arrays were performed on evs. mirnas were quantified in placental tissue via qpcr. results: em and western blotting confirmed isolation of evs and nta revealed no significant difference in size/ concentration in gdm-lga pregnancies (n = ) compared to gdm-aga (n = ; p > . ). several ev mirnas were altered in maternal circulation in gdm-lga compared to gdm-aga (n = /group; >twofoldchange; p < . ), including four skeletal muscle-specific "myomirs": mir- - p, mir- a- p, mir- b, and mir- a- p (all increased). all four myomirs were present in placenta but only mir- - p was significantly altered in gdm-lga compared to gdm-aga (n = - /group; p < . ). summary/conclusion: ev-bound myomirs could have predictive value for aberrant foetal growth in cases of gdm. mir- - p regulates vascular development in other systems, so we propose that mir- - p contributes to lga by influencing placental vascular development, however further work is required to establish this. introduction: seminal plasma is particularly rich in extra cellular vesicles. myelinosomes are membranous organelles described throughout the seminiferous epithelium of the testis but never reported in semen. the aim of this study was to look for the presence of myelinosome vesicles in human seminal plasma. methods: because of the viscosity of seminal gel and its water-holding capacity, classical transmission electron microscopy does not seem to be an optimal technique to reveal the presence of myelinosomes in this fluid. cryo-electron microscopy is a technique that allows visualization of nanosized structures without prior fixation or addition of heavy metals for contrast. the sample is therefore visualized as close to its native state as possible. using standard myelinosome preparation from tm sertoli cells, we first analysed the appearance of "standard" native myelinosomes by cryo em and then compared it with the vesicles from human seminal plasma samples. results: we have specified by cry-em the morphological aspect of "standard" myelinosomes isolated from the culture media of tm sertoli cells. the vesicles with the same morphological appearance were revealed in human seminal plasma specimens. summary/conclusion: myelinosomes are membranous organelles found in the seminiferous epithelium of the testis and secreted by the somatic sertoli cells in the lumen of the seminiferous tubules.the preparations from human seminal plasma contains a population of large ev (average diameter nm) whose morphological appearance resemble those of myelinosomes. defining the specific biomarkers and functionalities of myelinosomes in human seminal plasma are the concerns to be addressed in our further research. introduction: more than one million patients worldwide suffer from tuberous sclerosis complex (tsc) and have mutations in either tsc or tsc genes. together, the tsc proteins regulate mtorc activity. all tsc patient post-mortem samples exhibit renal disease and % of patients with tsc experience a premature loss of renal function. mouse and human studies are incongruity with the second somatic hit mechanism of disease, because of the low percentage of cystic cells exhibiting loss of tsc expression. we posited that the loss of a tsc protein expression may alter extracellular vesicle (ev) biology and contribute to disease. methods: we used crispr/cas to disrupt the tsc gene in mouse inner medullary collecting duct (mimcd) cells, and isolated evs using gel filtration from the isogenic cell lines. we characterized the evs using tunable resistive pulse sensing (trps), dynamic light scattering (dls), transition electron microscopy (tem), and wester blot analysis. we further performed mass spectroscopy on the ev proteins. results: loss of the tsc gene in mimcd cells induced a greater than three-fold increase in ev production compared to the same cells having an intact tsc axis. electron microscopy confirmed the purity and spherical shape of evs. both trps and dls demonstrated that the isolated evs possessed a heterogenous size distribution. approximately % of the evs were in the - nm size range. western blot analysis using proteins isolated from the evs revealed the cellular proteins alix and tsg , the transmembrane proteins cd , cd and cd , and the primary cilia-related hedgehog signalling-related proteins arl b. proteomic analysis of evs identified a significant difference between the tsc -intact and tsc -deleted cells that correlated well with the increased production. summary/conclusion: evs may be involved in tissue homoeostasis and cause disease by overproduction and altered protein content. the evs released by renal cyst epithelia in tsc complex may serve as a tool to discover the mechanism of tsc cystogenesis and in developing potential therapeutic strategies. introduction: we have shown that evs derived from amniotic fluid stem cells (afsc) of mouse origin present therapeutic effect in an animal model of chronic kidney disease, alport syndrome (as). in light of clinical translation, we isolated afsc-evs of human origin, characterized their cargo and evaluated thier therapeutic effect in vivo. methods: human clonal afsc were derived from amniotic fluid collected after volunteer donors provided consent. evs were obtained from afsc and identity and purity were assessed by rna-seq and proteomics. potency of hafsc-evs was evaluated by performing in vivo studies. ev biodistribution was evaluated by mri and therapeutic effect by measuring renal function and mice life-span. bulk rna-seq was performed on glomeruli obtained from injected and non-injected mice to identify potential ev regulating targets. results: proteomic profiling identified intact proteins and rna-seq data identified , mirs in hafsc-evs. hafsc-ev "fingerprint" was assessed by performing go analysis on the most highly expressed proteins and mirs. the results identified pathways involved in tissue homoeostasis such as mtor pathway, tgfβ and vegf pathways. when injected in vivo into as mice, biodistribution studies showed that hafsc-evs localized in the kidney, corrected proteinuria. no side effects (including teratoma) were noted in the treated mice. rna-seq of glomeruli obtained from treated as mice showed similar gene expression patterns to wilt type mice, by cluster analysis. our data indicated that hevs highly modulated pathways involved in collagen and matrix deposition remodelling, in addition to downstream targets of vegf, fgf, tnf, angiotensin and preserved glomerular cells structure and function. summary/conclusion: our protocol for hevs derivation is reproducible and allows derivation of ev lots with the same identity (specific cargo of proteins and mirs) and potency (present therapeutic effect in as). hafsc-evs modulated signalling pathways that are central to maintaining glomerular homoeostasis and preserved glomeruli structure with improved kidney function. this suggests the possibility of using hafsc-evs as a new therapeutic option for treating renal failure in humans. introduction: recent studies have shown that stem cell-derived extracellular vesicles (msc-ev) therapy improves renal outcomes in models of acute ad chronic renal disease. however, to better investigate the molecular mechanisms of ev-induced regeneration, and to define new ev sources, devices that mimic d organ architecture and flow conditions are needed. the aim of our work is to evaluate the regenerative potential of naïve and engineered ev in a millifluidic in vitro d model of glomerular damage in continuous perfusion. methods: methods: we set a millifluidic in vitro d model of glomerular filtration, a three-layers structure composed by human podocytes and glomerular endothelial cells, and, in between, of a basement membrane of collagen type iv. the barrier thus formed is set up inside a bioreactor, in a closed milli-fluidic circuit in which fluid flows continuously at a certain flow rate. we reproduced different pathological conditions and tested the localization and effect of evs in a dynamic system. : results: we obtained a standardized protocol and an adequate configuration of the milli-fluidic circuit subject to continuous reperfusion. renal damage was induced by doxorubicin or by hypoxia-reperfusion injury. we evaluated uptake, cargo transfer and effect of naïve and mirna engineered msc-evs or of klotho engineered ineffective evs administered into the dynamic co-culture system. evs were able to pass through the system and to deliver to podocytes proregenerative factors, promoting survival and limiting permeability. introduction: worldwide, renal cell carcinoma (rcc) is th most common cancer in men and th most common in women. new biomarkers are needed to aid rcc-diagnosis, provide prognostic information, and to predict response to modern targeted therapies. extracellular vesicles (evs) are an emerging source of cancer biomarkers because all cells, including cancer cells, secrete evs into biofluids as blood and urine. however, benign cells contribute to ev populations isolated from blood and urine reducing the diseasespecificity. we have developed a protocol for ev isolation directly from human rcc tissue that can increase tumour-specificity of biomarkers. methods: we obtained technical and biological replicates from normal kidney tissue and clear cell rcc tissue. serum-free media was incubated with the specimens. a combination of differential centrifugation, filtration, and ultracentrifugation was used for ev isolation. evs were quantitated using two methods, allowing for comparison between nanosight ns and nanofcm. tem was used to determine presence of intact vesicles in the ev samples. presence of ev introduction: urothelial carcinoma (uc) is a malignant cancer that affects the urothelial cells, representing % of all bladder tumours. at diagnosis % of bladder cancers are non-muscle invasive tumours. importantly, upon transurethral resection of the bladder tumour, nearly - % of these patients will experience disease relapse and - % will progress to muscle invasive tumour, requiring thereby, a rigorous and expensive follow-up. currently, this is performed through the frequent use of highly invasive cystoscopy and the low sensitivity urine cytology. thus, innovative liquid biopsy-based biomarkers that circumvent these drawbacks are highly desirable for improved uc clinical management. here, we aim to implement a protocol for the isolation and characterization of extracellular vesicles (evs) from uc patients' urine samples. methods: a two-step protocol involving ultracentrifugation (uct) and by size-exclusion chromatography (sec) was optimized for urine samples. the isolated urine-derived evs from uc patients were then characterized according to their size, concentration (nta), morphology (tem), protein amount (lowry method), presence of ev-associated and disease-associated protein markers (western blot). results: isolated urinary evs from uc patients had a size ranging from nm to nm with characteristic ev morphology, express ev-associated markers as cd and hsp and were negative for cell debris markers. the recovery yield and purity of isolated evs following each isolation technique was characterized. upon uct, sec was required to deplete most of the ev-associated thp and albumin protein contaminants. some disease-associated protein markers were highly enriched in isolated urinary evs compared to crude urine. summary/conclusion: taken together, these results indicate that a two-step ev isolation protocol was properly implemented and validated in uc patients' urine samples. notably, several ev-associated disease biomarkers were detected in the urine of uc patients. this ev-based liquid biopsy might provide the means for real-time monitoring of residual disease and relapse in uc patients. introduction: glioblastoma multiforme (gbm) is a very aggressive type of brain tumour. different gbm molecular subtypes (proneural, mesenchymal and classical) often co-coexist within the same tumour, with the mesenchymal subtype driving the tumour progression. recently, our lab demonstrated that the cargo of extracellular vesicles (evs) could mirror the molecular background of the gbm cells from which they were derived. altogether, we believe that gbm cell-derived evs can be directly involved in the expansion of the mesenchymal signature in tumours, thus supporting gbm aggressiveness. methods: non-mesenchymal (t & u ) gbm cells were "primed" using evs derived from mesenchymallike (u & ln ) gbm cells. ev-primed gbm cells were then co-cultured with their non-primed counterparts to determine whether the mesenchymal signature can "spread" from cell to cell via evs. effect on cell proliferation, migration and invasion (in hyaluronic acid hydrogels) was assessed following ev treatment and co-culture. the expression of mesenchymal gbm markers was measured by western blotting. further mass spectrometry analysis of cell and ev content was undertaken to describe potential underlying mechanisms. results: co-culture with ev-primed gbm cells significantly increased proliferation and hydrogel invasiveness of non-mesenchymal cells. interestingly, the stimulating effect of co-culture was even stronger on the proliferation of ev-primed gbm cells. moreover, further proteomic analysis revealed that expression of mesenchymal gbm markers such as cd was increased in non-mesenchymal cells following coculture. summary/conclusion: our data suggest that evs from mesenchymal gbm cells can be uptaken by gbm cells from different subtypes, thus stimulating tumour progression. overall, we think the present study provides with new insights for the understanding of gbm recurrence and the development of potential therapeutic strategies. introduction: triple-negative breast cancer (tnbc) is the most aggressive form of breast cancer. previously we reported that the heterogenous population of evs released from tnbc cells promotes the growth and aggression of recipient cells. here we investigated if, by using compounds proposed to inhibit ev release i.e. calpeptin and y (to block those budding at cell membrane) and gw and manumycin a (to block evs from mvbs), we could reduce the associated transmission of aggressive phenotype. methods: evs were separated from medium conditioned by tnbc cell line hs ts(i) , using a discontinuous optiprep density gradient, after the cells were treatment for hrs with the compounds listed above. evs (pooled fractions - with a density range of . - . g/ml) were characterised by nta, bca, lipid assay, immunoblot, tem and flow cytometry. to investigate the functional effects of the evs released, proliferation and migration assays were performed on hs t and mda-mb- cells using the ev to cell ratios of × evs/ x cells, × evs/ x cells, × evs/ x cells to evaluate doseresponse. ev-track id ev (score of %). results: gw significantly (p = . ) decreased ev release from hs ts(i) cells. manumycin a and a combination of calpeptin and y (combo) decreased ev release, but significance was not reached. conversely, calpeptin and y actually increased ev release; but not significantly. of the reduced numbers of evs released following gw treatment, hla-dr+ evs were significantly (p = . ) enriched. none of the evs analysed significantly changed hs t or mda-mb- growth rates. however, evs from cells treated with calpeptin (p = . ), gw (p = . ), manumycin a (p = . ) and combo (p = . ) caused significant reduction in mda-mb- migration compared to the effects of evs from untreated cells. similarly, ev from cells treated with gw (p = . ), and combo (p = . ) caused significant reduction in hs t migration. summary/conclusion: while gw was the only compound that caused a significant decrease in quantities of ev released, the evs that continued to be released following treatment with gw or calpeptin and y significantly reduced migration of both recipient cell lines. funding: phd funding: tcd scholarship and carrick therapeutics ltd extracellular vesicles from highly metastatic lung cancer cells induce barrier impairment, permeability, and epithelial-to-mesenchymal plasticity in a -day mature bronchial epithelium purdue university, west lafayette, usa introduction: epithelial-to-mesenchymal (emt) transition plays an integral role in cancer metastasis, which is responsible for as much as % of cancer mortality. cancer exosomes induce emt in bronchial epithelial cells, however, the epithelial cells inhibit emt when allowed to form a mature epithelial barrier with apicalbasal polarity. it is not known if cancer-derived extracellular vesicles (evs) can induce emt and more importantly, barrier disruption in a mature epithelium. here, we show that evs from a highly metastatic lung cancer cell line (calu ) are) are not only sufficient to induce emt in non-tumorigenic bronchail epithelial cells (beas- b), but are also capable of disrupting a -day mature bronchial epithelial barrier by significantly reducing teer, inducing sixfold increase in permeability and complete loss of e-cadherin at cellcell tight junctions. methods: beas- b and calu evs were characterized using electron microscopy, nanosight and western blotting for exosome-specific features. for permeability studies, beas- b cells were cultured in transwell for days to establish an intact epitheliumconfirmed by measuring teer (trans-epithelial electrical resistance). intact beas- b monolayers were treated with calu evs at , and μg/ml for hrs, and barrier intactness and permeability were evaluated by measuring teer, apical-basolateral translocation of dextran beads and confocal imaging of tight junctions (e-cadherin). for emt experiments, beas- b cells treated with calu evs at and μg/ml were evaluated for ecadherin and vimentin levels by qrt-pcr and western blot after hrs. results: beas- b and calu evs were enriched in - nm size range, and cd and cd were enriched in the ev fraction in contrast to the cell lysate and vice versa for gp . calu evs significantly impaired day mature beas- b monolayer's barrier properties, which at the highest dose caused % reduction in teer from . ± . to . ± . Ω.cm (n = ). this was further confirmed by~sixfold increase in dextran beads' apical-basolateral translocation in min ( . ± ng/ml in control vs . ± ng/ml in treated) (n = ) and complete loss of e-cadherin expression at cell-cell tight junctions (n = ). at the transcript level, calu evs induced significant downregulation of e-cadherin by % and upregulation of vimentin (mesenchymal marker) twofold (n = ) in beas- b cells, indicating transition into mesenchymal phenotype. summary/conclusion: we demonstrated the involvement of evs derived from highly metastatic lung cancer cells in inducing emt in bronchial epithelial cells and epithelial barrier disruptionthe initial stage of the intravasation process. grp plays a crucial role in the extracellular vesicle-promoted radioresistance of irradiated head and neck cancer cells introduction: small evs released from irradiated head and neck squamous cell carcinoma (hnscc) cells increase resistance of recipient hnscc cells to radiation in vitro. we have identified the glucose-regulated protein (grp ), a chaperone protein of the hsp family which is involved in cellular stress responses and associated with worse survival in head and neck cancer patients, as an essential component of the ev-mediated radioresistance. methods: small evs were isolated from conditioned medium from irradiated and non-irradiated bhy hnscc cells by combined microfiltration ( . µm) and differential ultracentrifugation. grp surface expression was measured by proteomic analysis, immunoblotting and bead-facs. radiation resistance of bhy cells was determined by a clonogenic survival assay. results: increased grp was identified on the surface of evs from irradiated cells. the increase in ev grp correlated with increased grp expression at the donor cell surface. the grp content of recipient cells also increased upon transfer of evs from irradiated, but not non-irradiated cells, ultimately leading to enhanced cell survival. to check a potential role of elevated grp in radiation resistance we overexpressed grp . here the modest ( x) overexpression of grp was sufficient to confer an enhanced radioresistant phenotype to the bhy cells. a correlation between grp -dependent increase of radioresistance and activation of the akt pathway is yet to be determined. summary/conclusion: our results suggest a pivotal role for ev-transferred grp in modulating the radiation response of recipient hnscc cells. radiation directly increases the cellular and vesicular grp levels, and subsequent ev-mediated transfer leads to enhanced grp levels and radioresistance in recipient cells. this study provides new mechanistic insights into the effects of evs in radiation response and elucidates an interesting target protein and novel strategies for the improvement of radiotherapy. d modelling of ev release in progressing prostate cancer introduction: the modelling of cancer progression should be capable to translate acquired knowledge of cell behaviour to the real human body conditions. however, the extracellular vesicles (evs) isolated from d cell models are commonly exploited in research. taking into account the specificity of the prostate cancer (pc) environment, and a strong need of early diagnosis of castrate-resistance by prostate cancer (crpc) patients, we suggest in-depth profiling of different ev subtypes isolated from d culture as a new tool to model the progressing pc. methods: cells from hormone-resistant prostate carcinoma -rv line were cultured in d and d conditions, using d coseedistm. acd plasma controlled for haemolysis and remaining platelets was taken from patients with pc and crpc. the fractions of ev subtypes from cell culture and plasma were obtained by differential centrifugation (dc) followed by iodixanol density gradient purification. each of the fractions was measured by nanoparticle tracking analysis (nta), tunable resistive pulse sensing (trps) followed by elisa. for that, cd and cd were used as ev markers, apob and apoa for lipoprotein contaminants control, and cd , cd and psma as tissue-specific biomarkers for determination of fractions containing evs of different origin. ev-contained fractions were subjected to next generation sequencing (ngs). results: in d conditions, the -rv cells produce up to -times higher ev number than in d. size and density distribution of evs derived from d cultures but not of d resembled plasma evs. size distribution and biomarker expression among different ev subtypes allowed distinguishing between pc and cprcderived samples, indicating a potential to translate these results into clinics for early cprc detection. summary/conclusion: this work demonstrates a new approach to study the secretome of a progressing pc under d conditions. the profiles of ev subtypes produced by cancer cells growing in a d spatial architecture resemble the profiles of plasma evs and can serve a useful tool for the establishment of new biomarkers. introduction: renal cell carcinoma (rcc) is the most common primary renal neoplasm, with over , cases in the us alone each year. early detection of rcc leads to consistently better patient outcomes, and extracellular vesicles (evs) isolated from patient samples may prove to be a valuable clinical tool in the future. evs are abundant in blood and urine and show a large amount of heterogeneity but are difficult to analyse due to their small size and difficulty in isolation. here, we employ a multiparametric analysis of ev surface markers to identify a set of markers that may prove clinically relevant in future studies. methods: rcc cell lines vok , vok , and vok were cultured in flasks containing ml of ev-depleted media ( % fbs, centrifuged hr x , g). when cells reached~ % confluency, the conditioned media was collected and spun at , g for mins two times to deplete any remaining debris, leaving~ ml of media. this media was concentrated to a final volume of~ ml using a pall jumbosep kda mwco filter. this concentrate was purified from protein by using an izon qev- column, collecting ml fractions. protein content of each fraction was analysed using a absorbance while concentration and diameter distribution were determined through nanoparticle tracking analysis (nta). pooled samples made of the three most concentrated fractions were concentrated to a final volume of~ µl using the pall microsep kda filter and then used for analysis in the miltenyi macsplex exosome kit. flow cytometric data were generated by the cytoflex s and analysed using flowjo and mpapass software. these positive signals were verified through bead-only controls and titrations. results: the mpapass software allowed for heatmap generation, data reduction, clustering and visualization of expression patterns. of the detection antibodies used across capture beads, cd , cd , cd , beta- microglobulin, and cd were found to be prevalent in these rcc evs. these markers were found to be co-expressed particularly with cd , cd , and cd . summary/conclusion: the use of multiplex analysis allowed for detection of five distinctive surface markers found to be prevalent in evs collected from rcc cell lines. these results demonstrate the utility of multiplex analysis and mpapass software for identifying potential markers of interest and provide proteins that are worth exploring further. the next steps to this work will be developing custom multiplex arrays that tailor capture and detection of evs specifically for rcc pathology. low molecular weight protein tyrosine phosphatase (lmwptp) carried by colorectal cancer cells-derived extracellular vesicles as a player in tumour-educated human fibroblast university of campinas -unicamp, campinas, brazil introduction: extracellular vesicles (evs) are doublemembrane-bound nanovesicles released by cells playing a key role as mediators of intercellular communication. low molecular weight protein tyrosine phosphatase (lmwptp) is upregulated in several cancers type, including colorectal cancer (crc), and it has been correlated with aggressiveness, chemoresistance and poor prognostic. methods: the aim of this study was to determine whether crc cells release lmwptp-enriched-evs and influence tumour microenvironment-associated cells as a representative tumour education. crc cells, hct and ht , were cultured in serum-free medium for hours. conditioned medium was concentrated by ultrafiltration (mwco kda) and evs were isolated by total exosome isolation reagent (invitrogen). evs were characterized by nanoparticle tracking analysis (nta), transmission electron microscopy (tem) and western blotting (wb). lmwptp levels were analysed by wb and sandwich-elisa. to evaluate tumour education, hff- fibroblasts were used as recipient cells. the uptake of evs (pkh fluorescently labelled evs), proliferation (viability) and migration (wound healing assay) were analysed in a co-culture model of crc-derived evs and hff- . results: nta showed a higher concentration of evs released by ht . hct and ht evs displayed a mean diameter around nm and a cup-shaped morphology. isolated evs were positive for evs-markers cd and tsg and negative for gm a non-evs marker. ht lineage as well as derived-evs are lmwptp-enriched in comparison to hct cells and evs. upon incubation, fluorescently hct and ht derived evs were internalized into hff- cells in a perinuclear region. evs derived from both cells increased the viability and proliferation of hff- cells. intriguingly, evs derived from ht promoted cell migration. summary/conclusion: in conclusion, for the first time, we showed that lmwptp can be carried by evs derived from crc cells and lmwptp-enriched-evs can modulate biological aspects of hff- fibroblast. overall, our findings point lmwptp out as important player in tumour-educated fibroblast. exosomal mir- a inhibition by vincristine and prednisone in paediatric acute lymphoblastic leukaemia. introduction: vincristine and prednisone are standard agents in treatment of paediatric acute lymphocytic leukaemia (p-all). mechanistically, vincristine induces apoptosis by blocking microtubules formation, while prednisone binds to cytoplasmic receptors and inhibits dna synthesis, both of which lead to apoptosis. the effect of these agents on exosomal micro-rna expression and its functional regulation is not yet investigated. elevated levels of mir- a in circulating exosomes (nanoparticles) has been shown to lead to progression in several cancers, including all. we have previously shown that leukaemia-derived exosomes induce leukaemia cell proliferation via up-regulating of mir- a expression and silencing of exosomal mir- a reverses this exosomeinduced cell proliferating effect. the objective is to investigate the effect of vincristine and prednisone on exosomal mi-r a expression in all. methods: jm , sup-b , and nalm- leukaemic cell lines were treated in vitro with vincristine ( . to . µm) and prednisone ( . to . µm) in exo-free medium and apoptosis was measured by mts assay. total rna of exposed cell lines was isolated and cdna was prepared for mir- a analysis. expression of mir- a was analysed by q-pcr. exosomes from conditioned medium of exposed cell lines were isolated by ultracentrifugation method. purity and particle size of exosomes were confirmed by western blot and nanoparticle tracking analysis (nta) assay respectively. total exosomal rna was isolated from exosomes (exo-rna) by trizol method. synthesis of cdna was carried out with the miscript ii rt kit (qiagen). results: vincristine and prednisone promote apoptosis in leukaemia cell lines (jm and sup-b ) in a dosedependent manner. both cellular and exosomal mir- a expression was down-regulated by vincristine and prednisone exposure in all three leukaemia cell lines (jm , sup-b , and nalm- ). these observations demonstrate that cellular mir- a down regulation in the parental cells is stable and can be transferred to exosomes, confirming the concept that exosomes are the fingerprint of parent cells. summary/conclusion: our data suggest that the vincristine and prednisone anti-proliferative effect in p-all maybe induced by another yet unexplored pathway, that suppresses mir- a at a cellular and exosomal level in p-all, resulting in apoptosis. funding: this project is supported by the dimartino family foundation. secreted extracellular vesicles from renal cell carcinoma cells anatoliy samoylenko, artem zhyvolozhnyi, eslam abdelrady, naveed ahmad, genevieve bart and seppo vainio oulu university, oulu, finland introduction: clear cell renal cell carcinoma (ccrcc) represents the most common form of kidney cancer and is among the most lethal of all genitourinary cancers. despite surgery and medication therapy, most patients with metastatic ccrcc have a poor prognosis. intratumoural hypoxia is a key factor involved in renal cancer progression and it is known to promote secretion of evs by many types of tumour cells. methods: rcc-derived renca cells, embryonic kidney derived ub cells, and primary mouse hepatocytes were used in the study. evs were purified from cell culture media by gradient ultracentrifugation, sequential ultracentrifugation and exo-spin™ columns. before ev isolation cells were kept for h either under normoxia or hypoxia ( % oxygen). evs were analysed by transmission electron microscopy with negative staining and immunolabeling, by nanoparticle tracking analysis (nta) and western blotting. cells proliferation and viability were assayed by live cell imaging using incucyte zoom (essen bioscience), cell metabolic activity by seahorse xf analyser (agilent), rna expression by qpcr and ddpcr. proteins were identified by ultra-performance liquid chromatography-mass spectrometry (uplc-ms). rna libraries were made using nebnext small rna library prep kit, and sequenced on nextseq (illumina). results: we showed that hypoxia induced production of evs by rcc cells, and characterized differences in protein and rna content of evs generated by renca cells cultured under normoxic and hypoxic conditions. we also showed that rcc-produced vesicles modify key features of tumorigenesis (gene expression, metabolic activity, motility, and growth) of target cells. these data were obtained by using two target cell types: model mouse kidney cells and primary mouse hepatocytes, which represent typical site of rcc metastasis with an exceptionally poor prognosis. we proposed that a possible mechanism of ev action in rcc is related to changes in caveolin- function. we also tracked renca-derived evs in a chick embryo model and in a novel kidney organoid co-culture assay developed by our group (xu et al., ) . summary/conclusion: hypoxia may influence tumorigenic properties of rcc by changing rates of production and composition of evs. funding: the study was supported by finnish cancer foundation grants. exosomes synthesizing her mirna and engineered to adhere to her on tumour cells surface exhibit enhanced anti-tumour activity introduction: exosomes are small extracellular vesicles averaging - nm in diameter. they serve as a means of intercellular communication. typically they consist of structural proteins as well as selected proteins, mirnas, mrnas, and long noncoding rnas. thus in an earlier report this laboratory designed a mirna targeting a major herpes simplex virus regulatory protein. as predicted by the nucleotide packaging signal the mirnas were packed in exosomes and on exposure to infected cells significantly reduced virus yields. her (human epidermal growth factor receptor ) plays an important role in the neoplasia of some breast cancers. the protein is exhibited on the cell surface and is the target of therapeutic antibodies. methods: firstly, we report on the construction of a mirna targeting the synthesis of her both in cells constitutively expressing her and in cells transfected with a plasmid encoding her . secondly, we report that the mirna targeting the synthesis of her reduced the viability of her positive cancer cells both in cell culture and in implanted tumours. lastly, we enhanced the anti-tumour activity of the exosomes by binding to the exosome surface a ligand with affinity for the her on the surface of tumour cells. the -mir-her exosomes package with mirna designed to block her synthesis and deliver to cells. these exosomes kill cancer cells dependent on her for survival but have no effect on cells lacking her or which were engineered to have her but do not depend on it for survival. the -mir-xs-her exosomes carry in addition a peptide which enables the exosome to adhere her on the surface of the cancer cells. in consequence, these exosomes preferentially enter and kill cells exhibiting her on their surface. the exosomes with -mir-xs-her are significantly more effective in shrinking the size of her -positive tumours implanted in mice than the -mir-her exosomes. summary/conclusion: our studies indicate that exosomes carrying mirna against her have no effect on her negative cells it was nevertheless desirable to increase the uptake of exosomes carrying the her mirnas by her -positive tumour cells. to this end we modified the exosomes to exhibit on their surface a peptide that bound the exosomes to the her on the surface of cancer cells. in consequence, we significantly enhanced the uptake of exosomes carrying the mirnas directed against her by her positive cells. funding: these studies were supported by grants from shenzhen overseas high-calibre peacock foundation kqtd , shenzhen science and innovation commission project grants jcyj , jcyj to shenzhen international institute for biomedical research. systematic characterization of ovarian cancer-derived exosomes unveil mirnas interfering with cd + t cell activation introduction: cd + tumour-infiltrating lymphocytes (til) have been widely reported to correlate with cancer patient survival, including ovarian cancer. even with the presence of tils, immunotherapy has limited success in ovarian cancer. understanding the interaction between cd + til and tumour cells is thus important. our hypothesis is that tumour-derived exosomes are released and taken up by cd + til such that specific mirnas contained within modulate physiological processes that inhibit cd + t cell activation. we aim to identify mirnas carried in tumour-derived exosomes that inhibit cd + t cell activation in ovarian cancer. methods: we purified exosomes from nine ovarian cancer cell lines and stocked in high concentration. interferon-gamma (ifn-gamma expression screening was performed after days of co-incubation of tumour derived exosomes, cd + t cells, and activators in conditioned medium. cell counts and viability were tested by trypan blue staining at day and day . rna-seq for exosomes were generated to identify mirnas critical in differentiation effects on cd + t cell activations. microrna target matching uncovered target mrnas while enriched pathway analysis predicted potential signalling pathways involved. results: our ifn-gamma screening results indicated the exosomes exhibit different behaviours in interfering cd + t cell activation owing to different donors. exosomes derived from peo. and ovca cells have consistent polarized results in ifn-gamma expression. exosomes derived from peo. remained a low ifn-gamma expression and from ovca stayed at relatively high level. small rnas profiling analysis between the two cell lines identified mirnas (p < . ), and mirnas have been reported with validated targeting information, and out of have targets involved in immune signalling. mrna targets were uncovered by target matching. cmap search identified complex connections among mrnas with the top enriched pathways actively involved in cell cycle and immune related behaviours. summary/conclusion: our ifn-gamma screening identified crucial mirnas in ovarian cancer exosomes interfering cd + t cell activation. computational modelling on both experimental and public multiomics datasets predicted promising signalling pathways of tumour-immune crosstalk for functional validation. irradiation of breast cancer cells alters the quality of dna cargo in the exosomes that they produce sheila spada, paul zumbo, doron betel, tuo zhang, nils-petter rudqvist and sandra demaria weill cornell medicine, new york, usa introduction: irradiation of breast cancer cells with an immunogenic dose ( gyx ) leads to accumulation of cytosolic dna that is sensed by cgas leading to interferon type i (ifn-i) signalling via cgas/sting pathway [ ] [ ] [ ] . we previously showed that tumour-derived exosomes (tex) secreted by irradiated ( gyx ) (rt-tex) but not untreated (ut-tex) tsa carcinoma cells carry dna that stimulates the production of ifn-i in recipient dendritic cells (dc) via the cgas/ sting pathway [ ] . moreover, mice vaccination using rt-tex, but not ut-tex, elicited anti-tumour immune response inhibiting tumour growth [ ] . here, we hypothesized that the differential ability of rt-tex and ut-tex to activate ifn-i in recipient dcs is due to qualitative differences in dna cargo of rt-tex compare to ut-tex. methods: the length of dna purified from tex and from the cytosolic fraction of tsa cells was measured by agilent bioanalyzer. the dna cargo of tex was analysed by whole-genome sequencing (wgs) and whole-genome bisulphite sequencing. the percentage of methylation of total dna in tsa cells was quantified by -methyl cytosine dna elisa kit. results: dna fragments with size between and bp were enriched in rt-tex compared to ut-tex, as well as in the cytosolic fraction of irradiated compared to mock-treated tsa cells. wgs revealed that the entire genome was represented in tex dna cargo, regardless of rt. more than % of tex dna was of nuclear origin, but mitochondrial dna was increased in rt-tex. interestingly, we found that rt decreases the level of methylation in both exosomal and total dna in tsa cells compared to the controls. summary/conclusion: these data support the hypothesis that immunogenic rt alters some characteristics of the exosomal dna cargo, mirroring molecular changes occurring in parent irradiated breast cancer cells. the enrichment in dna fragments of - bp in rt-tex is intriguing considering that cgas is optimally activated by dna in this length range [ ] . we are currently investigating which features of the cargo dna that differ between ut-tex and rt-tex may explain the differential ability to induce ifn-i pathway activation in recipient dcs. the identification of a dna signature associated with the ability of tex to activate the cgas/sting pathway could provide a circulating biomarker of the rt-driven immunogenic tumour response. introduction: triple negative breast cancer (tnbc) is among the most difficult cancer subtypes to treat and continues to cause a high number of cancer-related deaths annually. extracellular vesicles (evs) transfer cell type-specific cargo and have important implications in disease initiation, therapy and outcome. upon treatment of cancer cells with low-dose chemotherapy, released evs are able to transfer phenotypic traits to other cancer cells. new treatment strategies for tnbc, like inhibitors of the er stress pathway (ire ) might impact on ev biogenesis, cargo delivery and response of cells in the cancer microenvironment. our aim is to identify immune modulatory alterations in breast cancer cells and cancer derived evs upon treatment with inhibitors of the er stress pathway. methods: human tnbc cell lines were treated with ire inhibitor mkc and cells were analysed for immune modulatory surface markers, like hla-i, b -h molecules and different integrins. mitochondrial and lysosomal activities were investigated by the use of a mito-and lysotracker and analysed by imagestream (isx) technology. extracellular vesicles were isolated from cell culture supernatants by sequential centrifugation, quantified by nanoparticle tracking (nta) and characterized by exosome bead array. single ev analysis of total cell free supernatants and of isolated evs was performed by isx and marker positive evs were quantified for absolute fluorescence signals and total amount by objectives/ml. ev uptake into t cells was investigated by the use of different ev labelling strategies. results: several immune relevant surface markers (hla-i and cd ) are downmodulated by ire inhibition across different cell lines. cell surface expressed cd and b -h show cell line specific downmodulation profiles upon ire inhibitor treatment. other immunomodulatory marker such as b -h and b -h , integrin cd , cell adhesion-promoting cd and stemness/metastasis marker (cd and ssea) are unaltered on ire treated breast cancer cells. cancer cell derived evs were tetraspanin positive (cd , cd , cd ), similar in number and showed differential expression of immune markers upon ire treatment. mitochondrial and lysosomal activities were unaltered under ire inhibition, whereas cell proliferation was diminished. no breast cancer-derived ev uptake of externally labelled evs into healthy t cells could be detected. summary/conclusion: ongoing analyses focus on the multicolour analysis of multiple markers on single evs by imaging flow cytometry and on the functional impact of cancer derived evs on t cells delivered by ev receptor binding. funding: dagmar quandt is supported by the sfi (cÚram research centre, /rc/ ), the european regional development fund and the dr. werner jackstädt-stiftung. chair: uta erdbrügger -university of virginia chair: larry harshyne -thomas jefferson university comparison of three isolation protocols to search extracellular vesicles signature in sickle cell disease patients introduction: sickle cell disease (scd) is an inherited disorder characterized by chronic haemolysis and continuous activation of different cell types. extracellular vesicles (evs) were described to be at increased levels in scd patient's plasma compared to healthy subjects and were associated with several clinical manifestations such as leg ulcers and stroke. scd patient's plasma has increased concentrations of haem, free-hb and other proteins and lipoproteins as chronic haemolysis consequence. here, we report the comparison of three mostly used isolation protocols to search ev signature in scd patient's plasma by flow cytometry. methods: blood samples were obtained from scd patients (n = ) following wisgrill et al., ( ) protocol. three different ev isolation protocols were used: differential centrifugation (dc), ultracentrifugation (uc) and size-exclusion chromatography (sec). lactadherin and calcein-am were used to detect phosphatidylserine (ps)+ vesicles and membrane integrity, respectively. platelet-derived evs (pevs), endothelialderived evs (eevs), leucocyte-derived evs (levs) and monocyte-derived evs (mevs) were quantified. silica beads were used to define evs gate and samples were acquired in the cytoflex cytometer platform. results: the quantification of pevs in uc, dc and sec samples was, respectively, x , , x and , x events/ml mean, eevs was , x , × and , x events/ml mean, levs was x , × and , x events/ml mean and mevs , x , , x and , x events/ml mean. uc samples demonstrated a higher concentration of evs, which could be more useful to functional studies than dc and sec, however, it took more time to separate than dc. dc was the fastest method to separate evs from plasma, being useful to study large patients cohorts, but showed the smallest overall number of evs. sec also demonstrated high capability to detect evs in plasma and the possibility of obtaining a purer sample, although it is the most expensive and time-consuming method among all tested. all evs populations were detected in the three protocols tested. summary/conclusion: in summary, all protocols tested were efficiently to detect evs in scd patient's plasma and the definition of the best protocol may vary based on the research aim and time and budget available. funding: fapesp / - . gabrielle lapping-carr, joanna gemel, yifan mao and eric beyer university of chicago, chicago, usa introduction: aberrant cell-cell interactions involving the endothelium are central to the pathophysiology of sickle cell disease (scd), including acute chest syndrome (acs), a deadly and unpredictable complication. we previously demonstrated that the plasma of scd patients contains increased circulating small extracellular vesicles (evs) compared to controls and that those vesicles can disrupt endothelial integrity in vitro by affecting adherens junctions and ve-cadherin. the current study was designed to examine the effects of those evs on other cellular junctions including tight (zonula occludens , zo- ) and gap junctions (con-nexin , cx ) and to test the hypothesis that the junctions would be more severely affected by evs isolated from patients during an episode of acs than by ones isolated from the same patient at baseline. methods: we identified subjects with scd in our biobank who had plasma isolated at baseline and at the beginning of an admission for acs. evs were isolated from platelet free plasma using established methodologies. to determine the effects on endothelium, cultures of human microvascular endothelial cells were treated with evs for h and studied by immunofluorescence, immunoblotting and rt-qpcr. gap junction-mediated intercellular communication was assessed following microinjection of lucifer yellow and neurobiotin. results: the distribution and abundance of zo- at the plasma membrane were minimally affected by scd evs. while baseline evs did not affect the distribution of cx , evs isolated during an episode of acs caused loss of cx from the plasma membrane. the integrated intensity of cx membrane staining was decreased bỹ % following treatment with acs evs. cx protein decreased on average by %, cx mrna levels by % and neurobiotin transfer by - % in cells treated with acs evs, compared to baseline evs. summary/conclusion: circulating evs in scd affect multiple components of endothelial junctions. gap junctions composed of cx are the most sensitive of the cellcell junctions, since their abundance and function are reduced by acs evs even when the endothelial monolayer appears intact. cx -mediated intercellular communication may be an early and sensitive event in the endothelial disturbance caused by evs in scd patients. funding: nih ul tr , comer hospital rbc race funds, ted mullin fund. the effects of platelet concentrate storage time on extracellular vesicle interactions associated with fibrin clot formation in-vitro jamie nash a , christine saunders b , amanda davies a and philip james a a cardiff metropolitan university, cardiff, uk; b welsh blood service, velindre university nhs trust, cardiff, uk introduction: platelet concentrates (pcs) have been utilised for decades to prevent bleeding in thrombocytopenic patients and to stop active bleeding. the storage of pcs however is a logistical challenge due to the limited day shelf life under standard conditions. during storage, platelets undergo a number of mechanical and biochemical changes contributing to the short shelf life of a pc. these changes are collectively known as the platelet storage lesion. platelet extracellular vesicles (pevs) are known to increase throughout pc storage, due to an increase in platelet activation. as pevs have previously been shown to be pro-coagulant and increase in annexin v binding over pc storage. the aim was to investigate the effect of pc storage time on extracellular vesicle interactions on fibrin clot formation. methods: pcs were sampled on alternate days up to days of storage and centrifuged to achieve acellular plasma. the plasma was subjected to ultracentrifugation ( , xg) to pellet evs. the size and concentration of evs was assessed using nanoparticle tracking analysis software, followed by a western blot to confirm evs were of platelet origin. the pevs were added at a fixed number to a control pooled plasma sample with added thrombin and tissue plasminogen activator. the time to clot and % lysis time were recorded by using the turbidometry of the plasma over time. results: evs isolated from the pc were confirmed to be of platelet origin by western blot using cd as a marker of platelet origin and cd as an ev marker. pevs caused a significant increase effect on the fibrin clot formation (p < . ) when compared to the control plasma. pevs also had a significant effect (p < . ) on the fibrinolysis time, extending the time taken to lyse the clot. characterization of mirna from serum derived exosomes in a mouse tibia fracture model of introduction: complex regional pain syndrome (crps) is a debilitating chronic disease that occurs after trauma to the periphery and is intimately associated with nerve injury. its presentation is often described as an injury that is disproportional to the inciting event and manifests neuropathic pain, systemic inflammation, and immune dysregulation. owing in part to our poor understanding of disease aetiology, current treatments for crps are insufficient and as a disease of exclusion there is a lack of quantitative diagnostic markers. exosomes are small extracellular vesicles (sevs) - nm in size which provide a means of cellular communication through their cargo molecules (protein, mirna, mrna, lipids) , and have demonstrated promise in uncovering mechanisms of disease manifestation and identifying potential diagnostic markers. we have shown previously that crps patients have differential expression of several mirnas in serum derived sevs as compared to healthy controls, but little is known on how this compares to the established mouse tibia fracture model of crps. methods: mice undergoing fracture were anesthetized and subjected to a unilateral tibia fracture followed by casting of the injured limb. after confirming the establishment of pain hypersensitivity, serum samples were collected from fracture model and control mice three weeks post-injury. sevs were isolated by differential centrifugation and characterized using nanoparticle tracking analysis, transmission electron microscopy and western blotting. rna-seq analysis is being performed to identify differentially expressed mirnas. results: nanoparticle tracking analysis showed no significant difference in the number or size of sevs present in the serum from the fracture model and control mice. rna-seq is ongoing and differential mirna expression in sevs from fracture model will be compared to control samples. comparative studies identifying mirnas that are common between crps patients and the rodent model will facilitate the development of correlational outcomes between preclinical and human studies. summary/conclusion: identification of similarities and differences between crps patients and animal models will aid in directing future studies at clinically relevant aspects of crps aetiology and identifying potential diagnostic markers for crps patients. extracellular vesicle-based liquid biopsy in acute myeloid leukaemia: a reliable source of residual disease biomarkers? introduction: acute myeloid leukaemia (aml) is an haematopoietic stem cell disorder with a poor -year survival rate. monitoring of measurable residual disease (mrd) in aml patients receiving chemotherapeutic treatment is useful to assess therapy response and predict relapse. indeed, many different leukaemia associated immunophenotypic protein markers (laips) are presently useful to detect mrd. nevertheless, their analysis currently requires invasive bone marrow aspirates, thus severely hindering real-time monitoring of the disease. therefore, alternative peripheral blood-based methods are highly desirable for an easy, real-time and costeffective monitoring of aml progression. this work aims was to assess the feasibility of a peripheral blood ev-based liquid biopsy method for aml disease monitoring, based on the detection of laips with a known negative impact on the prognosis of aml. methods: the profile of evs isolated from paired samples from aml patients' blood plasma collected at diagnosis, complete remission (and some at relapse) was compared and correlated with clinical data. for that, a size-exclusion chromatography (sec) method was optimized to isolate the circulating evs from the blood plasma. the evs of the paired aml patients' blood samples were then characterized according to their size (dls/nta), morphology (tem), proteinto-lipid ratio (lowry/sulpho phosphovanillin assay), surface charge (zeta-sizer) and protein cargo (western blot). results: sec allowed the isolation of size-resolved plasmaderived evs from the peripheral blood of aml patients. isolated evs had a size ranging from nm to nm with an intact morphology, expressing ev-associated markers such as hsp , cd , cd and cd . size-resolved evs also had a differential expression of mitofilin, actinin- , syntenin- and annexin-xi proteins. several laips were detected in the isolated evs and their relative abundance changed throughout the stage of the disease. summary/conclusion: our preliminary data shows that aml patients' circulating evs carry relevant immunophenotypic protein markers, which might predict aml clinical outcome. introduction: cell plasticity regulated by the balance between the epithelial-to-mesenchymal transition (emt) and met is critical in the metastatic cascade. extracellular vesicles (evs) may play an important role in this balance by shuttling molecular cargos into recipient cells. this study aims to evaluate the feasibility of profiling mrnas of parental prostate cancer (pca) cells with different phenotypes and their daughter evs using the nanostring low rna input ncounter assay. methods: pc -epi and pc -emt cell lines representing epithelial and mesenchymal phenotype, respectively, were generated from original pc cell line. the cell culture supernatant was first pre-cleared for any dead cells and debris by centrifugation at × g for min. without disturbing the pellet, the supernatant was then transferred to a fresh ultracentrifuge tube and centrifuged at , × g for min at °c. the remaining supernatant was then centrifuged to isolate the evs at , × g for min at °c. the evs pellet was further washed in × pbs followed by a second centrifugation at , × g for min at °c. the final evs pellet was resuspended in × pbs for subsequent characterization (transmission electron microscopy, nanoparticle tracking analysis and western blot) and ncounter assays. the total rna of cells and their daughter evs were assayed by the ncounter pancancer progression panel to determine expression of selected mrnas. the nanostring ncounter low rna input kit with the multiplex gene primer pool was used for the pre-amplification of mrna and overnight hybridization with the pancancer progression panel. each sample type was submitted to the assay in biological triplicate. results: when comparing all samples, eisen cluster analysis separated all the cells and all evs into two groups, regardless of their phenotypes. in subgroup analysis, the expression patterns between pc -epi and pc -emt cells were significantly different. clec b, kdr, crip , il ra , cc d b were significantly upregulated in pc -emt cells, while cxcl , epcam, esrp , tgfb , cdh , s a , ovol were significantly downregulated in pc -emt cells. the expression patterns between pc -epi and pc -emt evs were also significantly different. tbx , cav , col a , slc a , myc, itgb , timp , camk b, ptgds, p h , itgb , vim, stat were all significantly downregulated in pc -emt cell derived evs. summary/conclusion: the nanostring low rna input ncounter assay can provide reliable mrna expression profiling of evs. the mrna expression patterns are very different between cells and their daughter evs. both cells and evs with different phenotypes have different gene expressions. cancer cell-derived evs containing alphav beta integrin regulate cd , il- and il- levels in peripheral blood mononuclear cells introduction: extracellular vesicles (evs) mediate communication in the tumour microenvironment and play an important role in cancer progression. previously, we have shown the enrichment of alphav beta integrin in small extracellular vesicles (sevs) isolated by differential ultracentrifugation and iodixanol density gradient from pc prostate cancer cells. we have also shown in the past that alphav beta -positive sevs induce peripheral blood mononuclear cell (pbmc) polarization by increasing the expression of pro-tumorigenic m markers, such as cd and cd . finally, we have demonstrated that down-regulation of alphav beta integrin up-regulates the stat -interferon stimulated genes (isgs) pathway in cancer cells and in sevs released by them. methods: in order to investigate whether prostate cancer cell-derived vesicular stat has a causal effect in pbmc polarization, we down-regulated alphav beta and stat in prostate cancer cells derived sevs using sirna as well as crispr-cas strategies. the sevs isolated from these cells were used to analyse m polarization by measuring the levels of cd in pbmc. the results show that sevs lacking alphav beta inhibit cd levels in pbmc in a stat -independent manner. analysis of cytokines released by pbmc upon incubation with sevs lacking alphav beta , show that pbmc selectively up-regulate the levels of il- and il- , which are predominantly anti-tumorigenic cytokines. in contrast, sevs lacking alphav beta do not upregulate pro-angiogenic cytokines, such as vegf. summary/conclusion: these findings suggest that cancer cell-derived sevs containing alphav beta integrin promote a pro-tumorigenic pbmc phenotype in the tumour microenvironment by regulating cd , il- and il- levels. introduction: the recognition of donor-mhc molecules by recipient t cells triggers the immune response leading to rejection of allografts. our recent studies have documented the presence of high numbers of recipient apcs displaying donor-mhc molecules (cross-dressed) on their surface in the lymphoid organs of mice after skin, heart or pancreatic islet transplantation. in addition, we have reported that acquisition of allogeneic mhc molecules by host apcs (mhc crossdressing) is mediated by donor-derived extracellular vesicles (evs) trafficking through blood and lymphatic vessels (marino et al. science immunology, ) . in the present study, we investigated the ability of allogeneic evs and allo-mhc-cross-dressed cells to initiate a t cell alloresponse in vitro and in vivo. methods: evs were isolated (using differential centrifugation) from balb/c bone marrow derived dendritic cells (bmdcs). these evs were used to cross-dress b splenocytes in vitro. the transfer of donor mhc class i and ii on b cells was analysed by imaging flow cytometry. next, t cells from b mice were cultured in vitro with either allogeneic bmdc-derived balb/c evs or b spleen cells crossdressed with allogeneic balb/c mhc. alternatively, × balb/c or b bm derived evs or × balb/c bm cells were injected iv to b mice. in both cases, the t cell response was assessed by activation markers detection, infg production and cell proliferation. results: apcs cross-dressed with allogeneic mhc molecules can trigger a pro-inflammatory direct alloresponse by t cells in vitro and in vivo. on the other hand, allogeneic evs alone were only able to induce early t cell activation but not proliferation in vitro. furthermore, injection of mice with allogeneic evs alone could induce some but suboptimal alloresponse in vivo and only when administered with complete freund's adjuvant. summary/conclusion: blocking donor evs release and subsequent recipient apc cross-dressing may represent a promising target to selectively inhibit anti-donor t cell inflammatory responses thus achieving long-term allograft survival. funding: r dk . antifungal antibiotic activity of outer membrane vesicles from adherent lysobacter enzymogenes c against therapeutic and biocontrol targets. rutgers university, new brunswick, usa introduction: lysobacter enzymogenes is a predatory gram negative bacterial species being studied for biocontrol activity against fungi. planktonic l. enzymogenes c produces outer membrane vesicles (omv) harbouring small molecule antifungal antibiotics (meers et al. ) . we show here that the more biologically relevant surface-associated c exerts remote antifungal activity via omv as well. the results have important consequences regarding the natural mechanism of biocontrol of fungal pathogens by c as well as isolation and delivery of therapeutically relevant antifungal compounds. methods: omv were isolated from scraped adherent c culture on agar by similar methods to meers et al . omv were stained in some cases with fluorogenic syto dna stain for microscopic observation. fungal growth was monitored via turbidity readings in liquid culture or photomicrographs on agar. c was also grown on polycarbonate filter membranes with defined pore sizes to monitor growth of fungal cells on the opposite side. vesicles were also labelled with an amine-reactive probe alexa- and washed x by sedimentation. binding of labelled omv to fungal cells was observed by epifluorescence microscopy. results: syto -stained vesicles from surface-adherent c were similar to previously observed~ nm vesicles (meers et al., ) . the isolated vesicles inhibited growth of saccharomyces cerevisiae or candida albicans in liquid cultures at similar potency and were active against the filamentous species fusarium subglutinans grown on agar or maize leaves. c cultures grown on filters with nm pore size but not nm were able to inhibit the hyphal growth of f. subglutinans on the opposite side. similarly c on filters with a nm pore size were able to inhibit growth of c. albicans. observation of fluorescently-labelled c omv after interaction with c. albicans showed binding specifically to hyphae or pseudohyphae and for f. subglutinans to the growing hyphal tips. summary/conclusion: the omv of c specifically bind and inhibit the growth of fungal hyphae of various species without direct c cell contact. these data elucidate mechanisms of biocontrol and suggest strategies for production of therapeutic antifungal antibiotics. meers et al. elucidating the cellular uptake and tissue distribution mechanism of cell derived vesicles, a novel therapeutic carrier hui-chong lau a , jae young kim a , jin-hee park a , jun-sik yoon a , min jung kang a and seung wook oh b a mdimune inc, seoul, republic of korea; b mdimune inc, seattle, usa introduction: cell derived vesicles (cdvs) are emerging as a novel therapeutic carrier. one of the crucial factors in the development and therapeutic applications of cdvs is to understand the precise mechanism by which vesicles find and enter the target cells. in this study, we aim to investigate the uptake mechanism of cdvs produced from natural killer (nk) cells using a manufacturing process established at mdimune inc. both in vitro uptake assay and in vivo distribution analysis were performed to provide precise insights into how cdv exert its effect at the cellular level. methods: nk cells were mainly used to produce cdvs. breast cancer cells, bt , and human and rodent endothelial cells, with a varying degree of icam- expression, were used to determine the effect of lfa- expressed on the surface of nk-cdvs in cellular uptake using facs and confocal imaging analysis. next, various inhibitors for uptake pathways, such as phagocytosis, dynamin dependent endocytosis, and receptor mediated endocytosis, were used to understand the underlying mechanism of cellular uptake of cdvs. biodistribution profile of cdvs were characterized using both normal and tumour xenograft models by ivis imaging. results: using a recently established manufacturing process, we demonstrate that nk-cdvs can efficiently enter the target cells. this study also shows that the cellular uptake depends on the molecular interaction between icam- and lfa- . in vivo distribution profile of nk-cdvs are also assessed using various tumour models. furthermore, we present a cellular uptake mechanism involved in the entrance of cdvs into the target cells. summary/conclusion: this study demonstrates that the cdvs produced at the manufacturing scale can be easily taken up by cells via specific cellular pathways. this finding will facilitate the development of more efficient therapeutics for cancer and other debilitating diseases. myofibroblasts-derived microvesicles increase dermal fibroblasts collagen production through plgf- syrine arif, sebastien larochelle and véronique j. moulin chu de québec -université laval, loex, québec, canada introduction: a proper wound healing of the skin involves angiogenesis, extracellular matrix (ecm) remodelling and re-epithelialization. these three mechanisms require well-organized interactions between different cell populations. a key role in this context is played by myofibroblasts (wmyo), a cell population mainly differentiated from dermal fibroblasts. these cells contract wound edges and synthesize new ecm. we previously showed that myofibroblasts predominantly produces microvesicles (mvs) and can favour angiogenesis. however, proteomic analysis of mvs from our previous studies indicated some molecules that can potentially be implicated in ecm remodelling. in this study, we evaluated whether myofibroblasts-derived mvs could affect dermal fibroblasts who are highly responsible for ecm regulation. methods: mvs were isolated by differential centrifugation of medium collected from wmyo cells. number and size of mvs were characterized by transmission electron microscopy and nanosizer. multiplex assays of cytokines were evaluated in mvs samples, wmyo and mvs-depleted medium. to examine the interaction of mvs with fibroblasts, we evaluated the uptake of mvs isolated from wmyo transduced with a fluorescent protein. we then treated fibroblasts cultures with mvs or a selected cytokine for days and evaluated collagen production. lastly, we neutralized the selected cytokine in mvs samples before evaluating collagen production. results: plgf- was the cytokine detected in mvs samples in large amount ( . ± . pg/µg proteins in mvs). fibroblasts treated with mvs or plgf- significantly stimulated pro-collagen i level production with a fold change of . ± . and . ± . . moreover, the neutralization of plgf- present in mvs significantly inhibited the production of pro-collagen i by dermal fibroblasts. summary/conclusion: our results indicated that mvs influence fibroblasts pro-collagen production through plgf- signalling. funding: this work was supported by natural sciences and engineering research council of canada (nserc) (rgpin - ); les fonds de recherche du québec-santé (frqs) via the research centre funding grant; the quebec cell and tissue and gene therapy network-thécell (a thematic network supported by frqs). structural insights on fusion mechanisms of extracellular vesicles with model plasma membranes introduction: extracellular vesicles (evs) represent a potent intercellular communication system. while their functional biological properties are more and more investigated, the biophysical aspects of their interaction with recipient cells are often overlooked. small size ( to a few hundred nanometres in diameter) of evs and their heterogeneous origin still pose a great challenge for their isolation, quantification and biophysical/biochemical characterization. in particular the complex network of interactions between differently classified evs and recipient cells remains to be further revealed. here we deeply investigate the fusion mechanism between evs and a model plasma membrane system by an interplay of different structural/morphological techniques to get a molecular description of the interaction helping to clarify the role of different membrane compartments on the evs uptake mechanism. standardized protocols and good manufacturing practice conditions were employed to derive highly stable vesicles of defined size and reproducible molecular profiles from umbilical cord multipotent mesenchymal stem (stromal) cells. after a thorough biophysical and biochemical characterization of evs non-contact liquid imaging atomic force microscopy (afm) and, in parallel, neutron reflectometry (nr), as well as small angle neutron scattering (sans) experiments were performed on evs to determine their interaction with model plasma membranes in the form both of supported lipid bilayers and suspended unilamellar vesicles of variably complex composition. results: we observed that evs tend to fuse with the model membranes with a preferential interaction with the external layer of the fluid membrane. moreover we revealed a stronger interaction with the liquid ordered domains, strengthening the hypothesis of a critical role of lipid rafts in fusion mechanisms. summary/conclusion: our results on the analysis of the interaction of evs with artificial lipid membranes could provide insights on the internalization mechanisms of evs. the approach shown here can be further extended to convey incremental complexity, adding glycolipid and membrane proteins to the model lipid bilayers. this approach combined with data on the specific biological function of each ev subpopulation as retrieved by standard functional assays, will turn useful to select the crucial molecular aspects of evs internalization by cells. introduction: platelet-derived extracellular vesicles (pev) are the most abundant circulating extracellular vesicle (ev) and exhibit platelet-like properties, hence the original term "platelet dust". direct phenotyping of ev surface markers within biofluids is challenging often requiring time-intensive purification steps that can significantly alter resultant ev population characteristics. the exoview™ (nanoview biosciences) specifically captures ev sub-populations and was used to characterise the ev content of platelet free plasma (pfp) and a potential novel haemostatic agent designed for the treatment of severe trauma and haemorrhage, platelet enhanced plasma (pep). methods: freeze-thaw cycling of platelet rich plasma/ expired platelet concentrates was followed by centrifugation to remove platelet remnants and yeilded pep. pfp controls were prepared by double centrifugation ( g for minuntes followed by , g for minutes). rotational thromboelastometry (rotem) and calibrated automated thrombography (cat) were used to assess ev driven haemostasis and thrombin generation. a dilutional and hypothermic model of coagulopathy was designed to assess pep. ev capture arrays comprised of anti-cd , anti-cd , anti-cd and anti-cd were used (exoview™, nanoview biosciences). captured vesicles underewent interferometric imaging and were quantified, sized and further probed with fluorescent tetraspanin markers, annexin-v and intravesicular markers. results: pep is highly procoagulant, exhibits enhanced thrombin generation and can restore haemostasis in a dilutional model of coagulopatic whole blood. pep can be generated from expired platelet concentrates, potentially allowing for upscalable production. the predominant vesicle population were pev with a large cd /cd population that contained a smaller subpopulation of phosphatidyserine positive procoagulant vesicles. pfp as expected has a much lower number of pev and a cd positive ev population. summary/conclusion: pep is a unique resuscitation fluid containing high pev levels for the potential treatment of severe trauma and haemorrhage. exoview measurements can be performed in unpurified plasma and may be useful for measuring circulating ev in health and disease. funding: defence and security accelerator, dstl therapeutic effect of exosomes in mice model of autism daniel offen a , reut horev a , nisim perets a , ehud marom b , uri danon b and yona gefen b a tel aviv university, tel aviv, israel; b stem cell medicine ltd., jerusalem, israel introduction: during the recent decade, exosomes that derived from mesenchymal stem cells (msc-exo) have been spotlighted as a promising therapeutic target for various clinical indications, including neurological disorders. we have previously shown that intranasal administration of msc-exo, cross the bbb and significantly ameliorate autistic-like behavioural phenotype in btbr and shank animal models of autism, representing a potential therapeutic strategy to reduce symptoms of autism spectrum disorder (asd). our objective is to study the mechanism of action and the cellular pathways in which the msc-exo activate their target, we performed rna sequencing analysis of primary neurons isolated from shank mice treated with msc-exo. methods: primary neuronal cell cultures were prepared from newborn shank homozygotes mice model of autism. cultures were treated with msc-exo ( ^ particles/ul), isolated from human adipocytes, followed by rna sequencing. the alterations in gene expression between the treated and intact neurons were analysed for gene ontology and pathways and were also compared to proteomics analysis of the msc-exo in order to find regulatory proteins that may lead to these differences. results: bioinformatic analysis revealed several up-regulators proteins that might be responsible for the increase in anti-inflammatory and protective factors seen in the mice neurons treated with msc-exo. one of them is bdnf which is known as an essential growth factor responsible for neuroprotection and neurogenesis. importantly, no difference in the genetic expression of cancer-related genes was identified following msc-exo treatment indicating for their safety. summary/conclusion: our data suggest that adipocytederived msc-exo carry therapeutic potential in asd via alternation in gene-expression related mainly to immuno-modulation, reduce neuroinflammation and increase neuroprotection and neurogenesis. the beneficial effects of the exosomes treatment in mice models is being translated into a novel, easy to administer, a therapeutic strategy to reduce the symptoms of asd. introduction: autologous blood-derived products gain increasing focus in regenerative medicine, especially in orthopaedics and osteoarthritis therapy. this disease is characterised by cartilage degradation and inflammation among other symptoms, which are targeted by conventional therapies, but genuine cartilage regeneration is rarely achieved. citrate-anticoagulated platelet rich plasma (cprp) is often clinically applied to stimulate soft and hard tissue healing. recently, cell-free alternatives to cprp including hyperacute serum (hypact™ serum) have been developed. cprp and hypact™ serum contain specific profiles of growth factors, however, they also contain extracellular vesicles (evs) that harbour signal molecules including mirna. methods: evs were enriched by ultracentrifugation (uc) followed by size exclusion chromatography (sec) to obtain purified evs. particle size and concentration of each fraction was measured by nanoparticle tracking analysis (nta). fractions with the highest amount of particles were pooled and concentrated via uc, before mirna expression was assessed via screening with a panel of mirna-specific primer pairs by rt-qpcr. presence of evs was confirmed by cryoelectron microscopy. results: the ev concentration tended to be lower in hypact™ serum than in cprp as determined via nta. similarly, lower diversity of mirna species was found in hypact™ serum than cprp evs. around % of detected mirnas were found in both blood products, whereas only % of mirnas were shared between evs from cprp and hypact™ serum. while mirnas such as mir- were consistently depleted in evs compared to the corresponding blood product, others like mir- a were in enriched in hypact™ evs, but not cprp evs, indicating release of specific mirnas via evs in response to clotting. summary/conclusion: although the purification resulted in high loss of evs, we identified specific mirnas enriched in evs from cprp and hypact™ serum. their functional spectrum with respect to osteoarthritis therapy focuses on inhibition of inflammation, inhibition of tissue remodelling via matrix degrading enzymes as well as preventing senescence. this renders blood product derived evs as interesting candidates for in vitro and in vivo testing with respect to cartilage regeneration. funding: the work was jointly supported by the european fund for regional development (efre) and the fund for economy and tourism of lower austria, grant number wst -f- / - . protective role of shiitake mushroom-derived exosome-like nanoparticles in d-galactosamine and lipopolysaccharide-induced acute liver injury in mice baolong liu, xingyi chen and jiujiu yu university of nebraska lincoln, lincoln, usa introduction: fulminant hepatic failure (fhf) is a rare, life-threatening liver disease with poor prognosis. new therapeutic interventions are urgently needed to treat this disease. administration of d-galactosamine (galn) and a low dose of lipopolysaccharide (lps) triggers acute liver damage in mice, which simulates many clinical features of fhf in humans and therefore is widely used to investigate the molecular mechanisms and potential therapeutic interventions of fhf. recently, suppression of the nucleotide binding domain and leucine rich repeat related (nlr) family, pyrin domain containing (nlrp ) inflammasome was shown to alleviate the severity of lps/galn-induced liver injury in animal models. therefore, the goal of this study was to identify food-derived exosome-like nanoparticles (elns) with anti-nlrp inflammasome function to potentially control fhf. methods: seven commonly consumed mushrooms were used to extract elns, which were examined for anti-nlrp inflammasome activities in primary macrophages. results: it was found that these mushrooms contained elns composed of biomolecules including rnas, proteins, and lipids. among these mushroom-derived elns, only shiitake mushroom-derived elns (s-elns) strongly inhibited nlrp inflammasome activation by blocking the inflammasome assembly. this inhibitory effect was specific for the nlrp inflammasome because s-elns had no impact on activation of the absent in melanoma (aim ) inflammasome. s-elns also inhibited the secretion of interleukin (il)- and both protein and mrna levels of the il b gene in macrophages. remarkably, pre-treatment of s-elns protected mice from lps/galn-induced acute liver injury. summary/conclusion: therefore, s-elns, identified as potent inhibitors of the nlrp inflammasome, represent a new class of agents with the potential to combat fhf. approaches to assess clinically available exosomes' quality and safety introduction: recent adverse events resultant from an exosome product use in a nebraska clinic, highlight the importance of assuring product quality and safety standards. an often-overlooked safety risk is ancillary reagents remaining within a finished product. when processes to obtain exosomes utilize cow proteins such as fbs or bovine sera albumin, failure to adequately remove these can result in significant adverse allergic reactions. we evaluated different exosome products to test the hypothesis that purity of some products may not be consistent with actual product quality and safety profiles claimed. methods: three different exosome products (manufacturer a, b, and c) were prepared per their instructions for use. sample source identity was blinded from assaying scientists. an independent cro service was used to conduct the experiments to ensure unbiased assay execution and data collection. exosome suspensions were sampled undiluted for bovine protein content using commercially available bovine secretome protein arrays from ray biotech. a total of different proteins found in bovine serum were quantified. results: six of proteins were not detected in any sample. of array antibodies were found to cross react with human antigens. of the bovine proteins that were acceptable for analysis, manufacturers a, b, and c exosomes contained of proteins, of proteins, and of proteins, respectively. concentrations of individual bovine proteins ranged from . to , . ng/ml. summary/conclusion: these results indicate manufactures a and b are selling potentially dangerous products. the successful implementation of exosome products into the clinic requires equivalent demonstrations of safety and quality. this requires adopting strict quality standards and safety testing during their production. physicians must require safety data prior to clinical use. engineering pro-healing ev cargo using a closed-system bioreactor. introduction: chronic wounds, including diabetic ulcers and pressure ulcers, are difficult and expensive to treat. while tissue engineering approaches have largely failed as a viable treatment for chronic wounds, we hypothesize that stem cell-derived extracellular vesicles (evs) may provide several unique advantages. zenbio, inc has developed a methodology to generate commercial-scale stem cell-derived exosomes using a closedsystem hollow fibre bioreactor capable of continuous ev production. additionally, we have shown that by manipulating the cellular environment, we can improve the pro-healing capacity of the evs.this technology leverages the complex healing capabilities of stem cells without the obstacles of replicating cells. methods: we have demonstrated that a mild heat shock resulted in evs enriched for stress-response proteins and increased pro-healing activities in vitro. we extended this innovative approach to include stimulating adipose stem cells with combinations of heat shock and growth factors to generate differential extracellular vesicle packaging that enhances pro-healing activity. to monitor reproducibility across lots and batches, we rigorously characterized tuned evs for particle size and number as well as surface marker and cargo composition. results: our results using tuned evs showed efficacy using cellular models of inflammation, motility, vascularization, collagen production and metalloprotease activity. we utilized an established murine model of pressure ulcers to assess the in vivo efficacy of the tuned evs. these studies showed a single injection into the wound site activated a more rapid wound closure, increased collagen deposition and reduced dermal thickness compared to saline control. summary/conclusion: these data strongly support our hypothesis that evs may be selectively modified to improve their wound healing activity by modulating the culture or tissue microenvironment. future studies will use chronic wound models to determine optimal dosing and routes of administration. introduction: mesenchymal stem cell-derived extracellular vesicles (msc-evs) can reduce inflammation, promote healing and improve organ function thereby providing a potential "cell-free" therapy. prior to clinical translation, there is a critical need to synthesize existing preclinical evidence supporting their efficacy. this systematic review provides the most comprehensive evidence map of methods, safety and efficacy for msc-ev research to date. methods: medline and embase were systematically searched for in vivo interventional studies using msc-evs. two reviewers extracted data for: ) methodology, ) study design, ) intervention details and ) efficacy/ adverse events. results: after screening articles, studies met our eligibility criteria. msc-evs were used to treat a variety of diseases including renal ( %), neurological ( %) and cardiac ( %) conditions. benefits were described in % of studies across all organ systems and adverse effects were seen in only three studies; two showing tumour growth. however, several key methodological concerns were evident. based on size criteria for ev subtypes (exosomes/small evs~ - nm, microvesicles~ - nm) only % of studies used appropriate nomenclature. ultracentrifugation ( %) and isolation kits ( %) were the most common isolation methods despite marked differences in yield and purity. evs were inconsistently dosed by protein ( %), particle number ( %) or cell count ( %), hindering inter-study comparisons. two-thirds of studies used xenogeneic evs suggesting immunocompatibility. techniques to determine size, protein markers and morphology was highly heterogeneous, and only and studies met the characterization standards recommended in the misev and guidelines, respectively. finally, % of studies did not incorporate randomization which represents a high risk for bias and only a quarter performed biodistribution studies. summary/conclusion: this systematic review reveals extensive heterogeneity in methods and intervention details for animal studies of msc-evs. nonetheless, nearly all studies showed significant benefits in a wide range of distinct conditions. the knowledge gaps we identified highlight important opportunities for improving preclinical design and the need for more standardized approaches in this growing field of ev therapeutics. msc-exosomes as next generation therapeutics for atopic dermatitis exocobio inc, seoul, republic of korea introduction: atopic dermatitis (ad) is a systemic inflammatory disease with unknown cause. recent approval of a targeted therapy, dupilumab, opens new era of ad management. however, current therapeutic options for ad are only targeting inflammation, a component of ad vicious cycle including itching and barrier disruption. human mesenchymal stem cells (mscs) have been highlighted as a novel therapy for suppressing allergic progress of ad in clinical studies. unfortunately, phase iii clinical study of human umbilical cord blood mscs for ad was failed with unknown reason. previously, our group reported that exosomes derived from human adipose tissue-derived mscs (asc-exosomes) alleviated the pathological symptoms in a murine ad model with concomitant reduction of inflammation. methods: our group has further investigated the therapeutic effects of human asc-exosomes in an alternative murine ad model with skin barrier defects. large scale isolation of asc-exosomes was performed by tangential flow filtration and isolated asc-exosomes were characterized according to the recommendation by the isev. the protein and lipid cargo were also analysed. results: we found that asc-exosomes induced restoration of skin barrier by inducing de novo lipid synthesis and reduced the levels of multiple inflammatory cytokines. in addition, asc-exosomes suppressed the expression of itching-causing cytokines. transcriptomic analysis of ad skin lesions revealed that asc-exosomes reversed the abnormal expression of genes functioning in skin barrier function, lipid metabolism, and cell cycle. summary/conclusion: taken together, asc-exosomes could be a promising cell-free therapeutic option for the treatment of ad, which affecting inflammation, skin barrier function, and itching. cell derived vesicles: unravelling the science of novel vesicles with therapeutic promises introduction: cell derived vesicles (cdvs) are nanosized vesicles produced by serially extruding cells through small pores. a growing number of studies have implicated their therapeutic potentials, with superior yield compared to other extracellular vesicles (evs). however, two key objectives remain to be accomplished to demonstrate the utility of cdvs in clinical applications. first, a manufacturing process has to be developed to allow a large-scale production of cdvs. next, these novel vesicles need to be thoroughly characterized at multiple levels. methods: manufacturing-scale extruders were developed to allow extrusion of large volume of cell suspension in a single process. cdvs with approximately - nm in diameter were obtained by a serial extrusion. crude samples were then purified using the tangential flow filtration method to further remove cellular impurities. finally, physical and biochemical characteristics of purified cdvs were analysed using dls, nta, cryo-em, and facs analysis. additionally, cdvs were subject to multi-omics profiling to comprehend our understanding in molecular contents of cdvs. both mesenchymal stem cells (mscs) and natural killer (nk) cells were used for this study. results: in this study, we first demonstrate that the large-scale extruder efficiently produce cdvs with consistent quality at the scale that are compatible for clinical applications. surface marker and membrane composition analyses show that the cdvs are primarily formed using plasma membrane of source cells, with characteristic cellular markers enriched on the surface. comprehensive profiling of molecular components reveals the unique properties of cdvs as well as the underlying mechanism of formation of cdvs. summary/conclusion: recently, we have established a manufacturing process to enable clinical applications of cdvs. this study also highlights key molecular features of cdvs that can be harnessed to offer a powerful tool for regenerative and anticancer medicine. antifibrotic properties of extracellular vesicles derived from human induced pluripotent stem cells introduction: fibrosis is a pathological condition resulting from abnormal healing of various tissues. it is triggered by activation of fibroblasts and their subsequent transition to myofibroblast. in consequence, excessive deposition of extracellular matrix proteins leads to impaired organ function. to revert this process, we employed extracellular vesicles (evs) derived from human induced pluripotent stem cells (hipscs). as a model system, we used human cardiac fibroblasts (hcfs), since heart fibrosis constitutes a serious socioeconomic problem worldwide. methods: we isolated evs from conditioned media from three hipsc lines using ultrafiltration combined with size exclusion chromatography methods. next, we analysed the evs by nanosight, transmission electron microscopy, mass spectrometry and western blot methods. finally, we treated tgf-b-stimulated hcfs with hipsc-evs and evaluated expression of fibrosisrelated genes using real-time qpcr, western blot and fluorescence microscopy. results: we detected anti-fibrotic properties of hipsc-evs exerted on hcfs pre-stimulated with tgf-b. the evs significantly decreased the expression levels of acta , fn, tnc, snai , col a and reduced the number of myofibroblasts. the canonical profibrotic tgf-b-dependent smad / pathway was significantly attenuated in response to ev-treatment. summary/conclusion: in this study we demonstrated strong anti-fibrotic function of hipsc-evs. our findings can further be exploited for future medical applications to treat fibrotic diseases, such as heart fibrosis. funding: this work was supported by the project sonata : umo- / /d/nz / from the national science centre of poland to sbw. induced pluripotent stem cells-derived extracellular vesicles ameliorates d-galactosamine and lipopolysaccharide induced acute liver failure tianjin third central hospital affiliated to nankai university, tianjin, china (people's republic) introduction: liver failure is among the most causes of death in patients with liver disease. promoting liver regeneration will help patients with liver failure recover on their own. extracellular vesicles (evs) can released by induced pluripotent stem cells (ipscs) through paracrine effects and play a pivotal role in inter-cellular communication in the treatment of disease. in this study, we investigated whether the ipscs-evs have therapeutic effects on acute liver failure. methods: the ipscs-evs were isolated by ultracentrifugation and identified using nanoparticle tracking analysis, transmission electron microscopy and western blotting. the isolated ipscs-evs were administrated d-galactosamine-injured heprg cells in vitro and tail intravenously injected into d-galactosamine and lipopolysaccharide induced acute liver failure model mice in vivo, respectively. the anti-apoptosis role and potential mechanism were evaluated using flow cytometry and immunofluorescence staining. and alanine transaminase (alt) and aspartate transaminase (ast) in serum, h&e staining and tunel staining were explored the effect of ipscs-evs on liver injured and liver function. finally, high throughput sequencing of small rnas was performed to investigate mirna expression profiles in ipscs-evs and ipscs. results: the ipscs-evs that were all - nm, doublelayered and oval or round cellular vesicles and expressed the marker proteins cd , tsg and hsp . in vitro, the ipscs-evs treatment inhibited heprg apoptosis induced with d-galactosamine in a time-and dosedependent manner and promote the proliferation of hepatic stem cells. in vivo results showed that ipscs-evs significantly alleviated liver failure, improved liver function and prolonged the survival period. tunel assay showed that ipscs-evs suppress apoptosis of hepatocytes. moreover, mirna expression profiles analysis found that mir - a cluster and mir - cluster were enriched in ipscs-evs and ipscs. summary/conclusion: these findings indicated that ipscs-evs could ameliorate d-galactosamine and lipopolysaccharide induced acute liver failure to attenuate hepatocyte apoptosis, which will be benefit for therapy of liver disease in the future. msc-derived extracellular vesicles promote human cartilage regeneration by control of autophagy introduction: osteoarthritis (oa) is a rheumatic disease leading to chronic pain and disability with no effective treatment available. recently, allogeneic human mesenchymal stromal/stem cells (msc) entered clinical trials as a novel therapy for oa. increasing evidence suggests that therapeutic efficacy of msc depends on paracrine signalling. here we investigated the role of bone marrow msc-derived extracellular vesicles (bmmsc-evs), an important component of msc secretome, in cartilage repair. methods: to test the effect of bmmsc-evs on oa cartilage inflammation the tnf-alpha-stimulated human oa chondrocytes were treated with bmmsc-evs and inflammatory gene expression was measured by qrt-pcr after h. to access the impact of bmmsc-evs on cartilage regeneration the bmmsc-evs were added to the regeneration cultures of oa chondrocytes, which were analysed after weeks for glycosaminoglycan content by dmmb and qrt-pcr. paraffin sections of the regenerated tissue were stained for proteoglycans (safranin-o) and type ii collagen (immunostaining). results: we show that bmmsc-evs promote cartilage regeneration in vitro. treatment of oa chondrocytes with bmmsc-evs induces production of proteoglycans and type ii collagen and promotes proliferation of these cells. msc-evs also inhibit the adverse effects of inflammatory mediators on cartilage homoeostasis. our data show that bmmsc-evs downregulate tnfalpha induced expression of pro-inflammatory cox- , pro-inflammatory interleukins and collagenase activity in oa chondrocytes. the anti-inflammatory effect of bmmsc-evs involves the inhibition of nfκb signalling, activation of which is an important component of oa pathology. autophagy, a cellular homoeostatic mechanism for the removal of dysfunctional cellular organelles and macromolecules, is essential to maintaining chondrocytes survival and differentiation. the expression of autophagy regulators is reduced in osteoarthritic joints, which is also accompanied by increased chondrocyte apoptosis. our preliminary data indicate that bmmsc-evs carry mrna of natural autophagy inducers and promote autophagy in oa chondrocytes. therefore, we hypothesize that msc-evs exert their beneficial effects on cartilage regeneration by restoring the expression of autophagy regulators. summary/conclusion: in summary, our findings indicate that bmmsc-evs have ability to promote oa cartilage repair by reducing the inflammatory response and stimulation of oa chondrocytes to produce extracellular matrix, the essential processes for restoring and maintaining cartilage homoeostasis. thus, msc-evs hold great promise as a novel therapeutic for cartilage regeneration and osteoarthritis. large-scale preparations of small extracellular vesicles from conditioned media of mesenchymal stromal cells modulate therapeutic impacts on a newly established graft-versus-host-disease model in batch dependent manners introduction: extracellular vesicles (evs) harvested from supernatants of humane adult bone marrow-derived mesenchymal stem/stromal cells (mscs) can suppress acute inflammatory cues in a variety of different diseases, including graft-versus-host disease (gvhd) and ischaemic stroke. furthermore, they can promote regeneration of affected tissues. following a successful clinical treatment attempt of a steroid refractory gvhd patient, we intend to optimize msc-ev production strategies for further clinical applications. as we observed functional differences of independent msc-ev preparations in vitro, we aimed to adopt an in vivo gvhd model for the more advanced functional testing of different msc-ev preparations. methods: to this end we set up a bone marrow transplantation mouse model in which endogenous bone marrow was myeloablated by ionizing irradiation (iir). gvhd was induced by the transplantation of major histocompatibility mismatched allogeneic spleen-derived murine t cells. if not treated otherwise, myeloablated mice developed severe gvhd symptoms. results: the gvhd symptoms were effectively suppressed, when msc-ev preparations were applied at consecutive days, which exerted immune modulatory effects in a mixed-lymphocyte reaction assay. msc-ev preparations lacking in vitro immune modulating activities, however, hardly improved the symptoms of the gvhd mice. thus, our results demonstrate that not all msc-ev preparations harvested from adult bone marrow-derived mscs contain the same therapeutic potential. summary/conclusion: thus, successful transplantation of msc-evs into the clinics requires a platform allowing identification of msc-ev preparations with sufficient therapeutic, most probably immune modulating activities. funding: this research was funded by sevrit leitmarkt lifescience.nrw ls- - - g. introduction: malnutrition impacts approximately million children worldwide and is linked to % of global mortality in children below the age of five. severe acute malnutrition (sam) is associated with intestinal barrier breakdown and epithelial atrophy. extracellular vesicles including exosomes (evs; - nm) can travel to distant target cells through biofluids including milk. since milk-derived evs are known to induce intestinal stem cell proliferation, this study aimed to examine their potential efficacy in improving malnutrition-induced atrophy of intestinal mucosa and barrier dysfunction. methods: mice were fed either a control ( %) or a low protein ( %) diet for days to induce malnutrition. from day to , they received either bovine milk evs enriched using differential ultracentrifugation and sucrose gradient purification or control gavage and were sacrificed on day , hours after a fluorescein isothiocyanate (fitc) dose. tissue and blood were collected for histological and epithelial barrier function analyses. results: mice fed low protein diet developed intestinal villus atrophy and barrier dysfunction. despite continued low protein diet feeding, milk ev administration improved intestinal permeability, intestinal architecture and cellular proliferation. summary/conclusion: our results suggest that evs enriched from milk should be further explored as a valuable adjuvant therapy to standard clinical management of malnourished children with high risk of morbidity and mortality. funding: cb was generously awarded a catalyst grant from the centre for global child health at the hospital for sick children to support this work. the impact of spheroids culture on mesenchymal stem cells and ev production introduction: mesenchymal stem/stromal cells (mscs) are now widely believed as bio-factories releasing bioactive products responsible for their therapeutic effect, i.e. cytokines, chemokines, and extracellular vesicles (evs). mscs are highly sensitive to physical stimuli from their surrounding microenvironment and can change their characteristics in response to their environment. the application of d spheroids cell culture allows mscs to adapt to their cellular niche environment which, in turn, influences their paracrine signalling activity. we aim to determine how d and d culture microenvironments can modulate the ev production and investigate their anti-fibrotic activity. methods: for d culture, bone marrow-derived mscs were cultured on standard tissue culture plastic. for d culture, mscs were aggregated into spheroids using non-adherent -well plates and cultured with addition of . % methylcellulose. to collect conditioned media, both d and d mscs were cultured using serum free medium for days. evs were isolated by serial ultracentrifugation and were characterised on exoview platform which allows simultaneous detection of particle size and expression of cd /cd /cd . cell lysates were collected for mirna isolation and qrt-pcr was performed to analyse expression of candidate mirnas. to model the progress of lung fibrosis, human lung fibroblasts (hlfs) were cultured with tgf-β to induce fibroblast activation, subsequently exposed to d and d evs, and collagen production was measured. further, d and d msc-evs were added into human lung mscs isolated from healthy and ipf patients and cell proliferation was assessed using mts assay. results: d and d msc-evs have similar ev characteristics in terms of particle size and ev tetraspanin markers expression. exoview analysis showed expressions of cd /cd /cd and average particle diameters of < nm. on a cellular level, we identified a panel of anti/pro-fibrotic mirnas which are differentially expressed in d and d mscs. d and d msc-evs have similar anti-fibrotic activity shown by their ability to reduce collagen deposition in hlf cultures. both d and d msc-evs could promote cell proliferation on ipf lung mscs but no overall effect on healthy lung mscs. summary/conclusion: this concept of engineering the cellular microenvironment to promote ev production is as yet untouched and we foresee that in d cultures, we can culture mscs for longer timeframe and therefore maximising the overall ev production process. the outcome presents future potential for d culture of msc to increase the efficiency and feasibility of scalable ev production. outer membrane vesicles from photobacterium damselae subsp. piscicida: characterization and antigenic potential introduction: photobacterium damselae piscicida (phdp) is a gram-negative bacterium that causes a septicaemia in > fish species worldwide. it represents a major drawback for aquaculture, whose importance has been sharply growing as a food supplier. given the phdp massive mortality and widespread antibiotic resistance, an effective vaccine is highly needed. extracellular products (ecps) have an essential role in phdp virulence, containing important antigens. however, the ecps' identity remain undisclosed. in our efforts to dissect their composition, we found that they contain high amounts of outer membrane vesicles (omvs). these particles are potent weapons for bacteria and are being explored in the field of vaccinology, since omvs present antigens in native conformations and are strongly immunogenic, without requiring adjuvants. this potential associated to the urgent need for an anti-phdp vaccine prompted us to isolate and characterize the omvs shed by phdp. methods: in order to harvest high amounts of pure phdp omvs, a reproducible optimized protocol was developed: the bacteria-free supernatant from a phdp overnight culture is concentrated, dialysed and ultracentrifuged to collect the omvs. results: analysis of the obtained omvs preparations by transmission electronic microscopy and dynamic light scattering indicate that the main population of vesicles has sizes around - nm. proteomic analysis of the vesicles revealed the presence of the apoptogenic ab toxin aip that is known to play a major role in phdp virulence, a putative pore-forming toxin, a putative adhesin/invasin and several outer membrane proteins (omps), including a kda omp, predicted to be involved in iron acquisition, and other omps ( - kda), with an ompa-like structure that may act as adhesins. moreover, preliminary in vivo studies suggest that some of those proteins may have important roles for virulence, since injection of knock-out strains in sea bass induced a decreased mortality comparing to the wt strains. summary/conclusion: our findings suggest that omvs are a promising vaccine candidate and we are currently studying their biological activities and determining the antigenic potential of the identified proteins. introduction: whole body exposure to high doses of ionizing radiation (ir) can potentially be lethal if radiation injury is not diagnosed and treated expeditiously. when considering a non-invasive approach for the identification of biomarkers of ir exposure, we and others have studied molecules in plasma, serum, saliva, and urine. however, these matrices can potentially have significant background noise, obscuring potential biomarkers of biological importance. extracellular vesicles (evs) are fast becoming a platform for biomarker discovery in radiation research as well as in other pathologies. however, no groups have investigated the use of metabolomics to analyse evs derived from urine in the context of ir exposure. furthermore, the dominant protocols for ev isolation from urine require a large (up to ml) amount of starting volume, which may not be available for many studies. the aim of this study was to optimize ev isolation from rat urine and assess radiation-induced alterations in urine ev number and metabolic content. methods: as a proof of concept, we compared and optimized several ev isolation methods on small volumes of urine from male wag/rijcmcr rats exposed to gy or gy x-rays to the whole body except the hind leg. starting with either µl or µl of urine, we isolated evs using ultracentrifugation (uc) with filtration, size exclusion chromatography (sec), and a proprietary bead-based isolation method developed by a rd party provider. ev samples were characterized using nanoparticle tracking analysis. metabolomics profiles were measured using lc-qtof-ms. results: we found that sec resulted in the highest yield of evs from as little as µl of urine, while uc was the poorest performing. lc-qtof-ms analysis revealed that sec and uc had the most consistent identification of features, whereas the bead-based method contained artefacts likely as a result of the extraction method. we next used sec to isolate evs from a larger cohort of rats exposed to ir and analysed with ms. ev metabolic content will eb related to differences in survival and organ function between sham and irradiated groups. summary/conclusion: we conclude that sec is the preferred method for isolating evs from small volumes of urine for broad-based mass spectrometric analysis, and that the ev metabolome may be a sensitive and specific early indicator of radiation injury. introduction: there is growing evidence that contents (including rna and proteins) of exosomes may serve as biomarkers for early diagnosis and prognostic prediction of cancers. here we aim to identify potential protein markers for oesophageal cancer. methods: using our newly developed label-free exosome automated preparation system (leaps), exosomes were isolated from ml culture medium of various oesophageal cancer cells with different differentiation profiles and different sources of metastasis. exosomes from µl plasma of cancer patients at different clinical stages or with/without relapse and healthy controls were also prepared by leaps. matrix-assisted laser desorption ionization time-of-flight mass spectrometry (maldi-tof ms) was employed to directly analyse exosomes. protein identities of exosomal fingerprint peaks were tentatively assigned by correlation with top-down and bottom-up proteomics. results: start from ml culture medium or µl plasma, high-quality exosomes rapidly isolated by leaps are sufficient for maldi-tof mass spectrometry. it seemed that poorly differentiated cells showed more exosome release. maldi-tof ms fingerprints of exosomes in cells is cell line specific. ms profiles from poorly differentiated cells showed more peaks than that from highly differentiated cells. fingerprints also allowed classification of cancer cell lines through software mathematical analysis. we identified different numbers of significantly differentially expressed peaks in exosomes of various cancer cells. fingerprints of exosomes derived from the poorly differentiated cells showed more elevated peaks. top four peaks ( , m/z, , m/z, , m/z, , m/z) were commonly down-regulated in exosomes of most cancer cells. top four protein peaks ( , m/z, , m/z, , m/z, , m/z) that might be correlated to the differentiation profile of cancer cells were also identified. maldi-tof ms detection of exosomes in the plasma and clarifying identities of potential biomarker peaks will be done in the future. summary/conclusion: the combination of leaps and maldi-tof mass spectrometry provides a fast and high-throughput tool for exosomal marker discovery. potential biomarker identified in exosomes derived from oesophageal cancer cells or from plasma of cancer patients by this tool might be useful in cancer diagnosis and prognosis. fraction-based proteomic profiling of serum extracellular vesicles derived from cervical cancer patients introduction: current evidence indicates that extracellular vesicles (evs) can release from most of cell types and affect adjacent or distant cells by circulating in all bodily fluids. proteomic analysis of evs from clinical samples is complicated by the low abundance of ev proteins relative to highly abundant circulating proteins. size exclusion chromatography (sec) has been overcome as a method to deplete protein contaminants and enrich evs. methods: we collected serum of healthy women and cervical cancer patients with stage i-iii and then counted concentration and size distribution of the evs using nanoparticle tracking analysis (nta). differential ultracentrifugation combined with sec was used to isolate and purify evs from contaminant proteins. isolated evs were investigated their characteristic based on morphology using transmission electron microscope (tem) and on expression of cd , cd , cd protein markers using western blot analysis. fraction no. - of isolated evs in among sample groups were profiled by nano-liquid chromatography tandem mass spectrometry (nanolc-ms/ms) analysis. results: nta shows that the concentration of evs is increased in patients compared with healthy women. proteome profiles of evs isolated by sec were compared in each fraction. moreover, we detected molecular evidence for fraction-specific molecular pathways in connection with cancer progression and complied a set of protein signatures that closely reflect the associated clinical pathophysiology. summary/conclusion: these unique features in each fraction among sample groups would be the informative considering in order to select for further analysis as in vitro. introduction: recently, diagnostic biomarkers from exosomes by proteomic analysis have been reported, but it is required to optimize the isolation protocol to screen out more effective biomarkers. for serum-originated exosomes, it has been also reported to isolate them selectively, however, it is observed that a different method resulted in different protein profiles in -d gel electrophoresis. methods: we isolated exosomes by two discrete methods, using ultracentrifugation and magnetic separation. before ultracentrifugation and magnetic separation, precipitation using polymer materials was perforemd. the isolation of exosomes by these two methods followed by comparison of their size, total vesicle number, morphology, and protein markers. to identify protein biomarkers, proteomic analyis using -d gel electrophoresis was performed. results: both methods induced enrichment of exosome-specific proteins, but protein profiles in each exosome fraction was totally different. the protein profiles showd that the magnetic seperation following a polymer-based precipitation step was more efficient to screen out candidate biomarkers, which showed nearly protein profiles originated from exosomes. summary/conclusion: in our study, magnetic separation of exosomes from serum fraction was optimized for -d gel electrophoresis to observe identifiable biomarkers. an extracellular small rna-seq data processing pipeline optimized for high-performance computing chenghao zhu and angela zivkovic department of nutrition, uc davis, davis, usa introduction: a variety of rna species is found in extracellular biofluids such as blood, bile, and urine, carried by extracellular particles including extracellular vesicles (evs) and lipoproteins (e.g high density lipoproteins (hdls)). the extracellular rna (exrna) carried by evs and hdls is of great interest for two reasons: ) the exrna within different carriers could be diagnostic of the state of the tissues from which the particles originate, and ) exrna has been shown to affect gene expression in target cells. although the origin and functions of exrnas remain largely unknown, there is growing interest in exrna research for the development of diagnostics and new therapeutic targets. small rna sequencing is widely used to estimate the abundance of exrnas in biofluid samples. here we present a data processing pipeline for extracellular small rna sequencing. sequencing data are pre-processed through quality control, and then aligned to the endogenous genome to obtain the gene counts for various rna biotypes, including microrna, trna, rrna, piwi-interacting rna, long non-coding rna (lncrna) and protein coding rna. it also aligns sequencing reads to exogenous databases, including the ribosomal rna sequence database silva, and all sequenced bacteria genomes available on ensembl, to estimate the abundance of exogenous genes. results: we analysed a publicly available small rna-seq dataset of hdl from three systemic lupus erythematosus (sle) patients and three healthy controls using this pipeline. the mirna hsd-mir- , lncrna al . and ac . were elevated in sle patients compared to controls. exogenous rna reads mapped to bacteroidetes were also elevated in sle patients. summary/conclusion: our pipeline is able to process exrna sequencing data and estimate the abundance of major exrna species, as well as exogenous rna taxonomy. the pipeline is optimized for the job scheduler slurm, and can therefore utilize the full computational power of high-performance computers. the pipeline is publicly available on github (www.github. com/zhuchcn/excernapipeline). introduction: ibd is a chronic hyperinflammatory disorder that severely compromises the intestines. the aetiology of ibd is poorly understood. however, it has been associated with a dysregulation of the immune system and gut microbiota and with genetic and environmental factors. cumulative evidence indicates that evs play an essential role in modulating immune responses. recent research suggests that evs derived from dendritic cells, saliva and intestinal epithelial cells may be involved in the progression of ibd inflammation. however, little is known about the contribution of immune cells-derived evs with this pathology. the goal of this study is to shed light on the contribution of pbmc-derived evs on ibd pathogenesis. here we characterized and compared the composition of evs derived from pbmcs of ibd patients and healthy control. evs were isolated by differential centrifugations from the supernatant of pbmc activated with cd -cd beads for days in serum-free media. size and concentration were analysed using a nano sight instrument, while the presence of known evs markers (cd , cd , hsp ) was analysed by immunoblotting. whole evs proteome was performed by ms/ms and functional-enrichment analysis was done using funrich with uniprot database. results: proteomics analyses identified a total of proteins in the four groups. of those, ( . %) were present in both the ibd patients and control. this group of protein was composed of several ras-related proteins, eukaryotic initiation factors, granzyme, cd , tubulin, and serpins among others. patients' evs shared proteins in common such as proteasome subunit beta type- , t cell receptor beta, and the amine oxidase containing copper . interestingly, each patient sample had a unique group of proteins. among these are myeloperoxidase, neutrophil elastase, proteasome subunit alpha type- , and signalling lymphocytic activation molecule (slamf ). summary/conclusion: these preliminary studies show that the ev composition from pbmcs of ibd patients is specific and differs from a healthy control. this exclusive composition has the potential to be used as a biomarker for diagnostics and progression of the disease, and it could also provide new insights into our understanding of the cellular pathways involved in the pathogenesis of ibd. the studies were performed with corresponding irb approvals. proteomic analysis of exosomes isolated using precipitation and columnbased approaches introduction: exosomes are a subtype of small extracellular vesicles (evs) involved in various physiological and pathological processes with huge potential as biomarker resources or as therapeutic tools. although several exosome isolation approaches are available, complementary studies focusing on optimizing the methods for human bloodderived exosomes isolation and method-specific comparative exosomal proteomic profiles will be of clinical value. methods: blood-derived evs were isolated through precipitation-and column-based methods and characterized by transmission electron microscopy, nanoparticle tracking analysis and western blot analysis. serumderived exosomal proteomes were analysed by mass spectrometry (ms). the resulting proteomes were then overlapped with the proteomes obtained from exosome-related databases, to determine the % of similar content. in addition, bioinformatic analysis, including gene ontology (go) was carried out. results: both methodologies tested isolated particles with the expected morphology and size range, although the column-based method isolated a higher number of particles. about % of the exosomal proteins identified through ms overlapped with the proteomes extracted from the databases. go terms were similar for the proteomes isolated from the column-and precipitationbased methodologies. the top go terms identified for molecular function were ion binding, peptidase activity and enzyme regulator activity and for biological process were immune system process, transport and response to stress. further, partial least square analysis revealed a clear segregation of proteomes obtained by the distint methodologies and complementary statistical analysis revealed the proteins differently expressed. summary/conclusion: no major differences were found in the top biological processes and molecular function based on go analysis. nonetheless, the two approaches result in different evs yields and significant proteome differences were identified. characterization of distinct methods for blood-derived exosomes isolation can be useful in the context of evs potential in disease diagnostics/therapeutics. introduction: we and others are developing biomarkers for neurodegenerative diseases using neuronalenriched evs immunocaptured from a suspension of total plasma evs. here we assess how the isolation method for total evs affects the yield, purity and enrichment of neuronal evs. methods: for n = subjects, total evs were isolated by ev precipitation solution (exq), ev precipitation solution plus bipartite resin columns (exu) and size exclusion chromatography (qev) from . , . and . ml plasma, respectively. then, neuronal-enriched evs were immunoprecipitated using anti-l cam antibody. in total and l cam evs, we measured particle concentration by nanoparticle tracking analysis, protein concentration, and novel multiplex electrochemiluminescence immunoassays for tetraspanins cd , cd and cd on intact evs. results: for total evs, yield followed the order of exq > qev > exu, assessed by particle (p < . ) and protein concentrations (p < . ). l cam evs immunocaptured after exq showed -fold higher particle (p < . ) and fivefold higher protein (p < . ) concentrations compared to l cam evs after exu, and -fold higher particle (p < . ) and -fold higher protein (p < . ) concentration compared to l cam evs after qev. l cam evs after ev precipitation (exq) showed , and -fold higher cd , cd , and cd concentrations (p < . ) compared to l cam evs after exu, and , and -fold higher cd , cd , and cd concentrations (p < . ) compared to l cam evs after qev. l cam evs following different methods had equal purity assessed by ratios of particle/protein concentrations (p = ns), and tetraspanin/particle concentrations (p = ns). summary/conclusion: l cam ev immunocapture preceded by exq exceeded the yield of immunocapture preceded by exu or qev. recovered l cam evs showed equal purity by particle/protein and tetraspanin/particle metrics. neuronal enrichment results will be available by the time of isev. immunoprecipitation following exq, often considered impure, purifies final isolates as effectively as more onerous methods typically considered purer. balancing sensitivity, purity and scalability is essential for implementation of blood biomarkers in the clinical setting and may be achieved by combining techniques. funding: this research was supported in part by the intramural research program of the nih, national institute on aging. characterisation of breath exosomes: towards non-invasive diagnosis deanna ayupova a , renee goreham b and paul teesdale-spittle c a school of chemical and physcial sciences, victoria univeristy of wellington, wellington, new zealand; b university of newcastle, newcastle, australia; c school of biological sciences, victoria univeristy of wellington, wellington, new zealand introduction: breath-derived exosomes present new potential for non-invasive diagnosis of lung cancer. however, breath-derived exosomes have not been well characterized and methodology for their purification has not been optimised. in order to exploit their potential for diagnosis, it is first necessary to develop methods that reproducibly provide high quality pure exosomes from breath. in this study, we optimise methods for their isolation and characterise them in comparison to exosomes derived from cell culture models. methods: in order to characterize exosomes from exhaled breath condensate (ebc) it was first necessary to optimize methods for isolation of pure, intact, and high quality exosomes. to this end, isolation methods were optimised on cell-derived exosomes and then applied to ebc, yielding high quality exosomes from size exclusion chromatography (sec). ebc exosomes were compared with those from a and wi-cells using dls, tem, and cryo-sem. an immunoblotting-grid technique was used to validate the presence of exosome-specific markers cd and cd . protein content of exosomes were quantified and compared. results: sec-based isolation was more effective at isolation of pure and intact exosomes than ultracentrifugation, with the highest purity exosomes obtained in the middle fractions of the exosome-containing eluate. exosomes from ebc had a size range ( - nm), protein content ( - ug/ml) and molecular markers typical of cell-derived exosomes. summary/conclusion: breath-derived exosomes isolated through size exclusion chromatography are sufficiently pure for diagnostic purposes and are phenotypically similar to exosomes derived from other sources. we foresee their use in non-invasive diagnostics for lung cancer as an important future application. ligand-based exosome affinity purification (leap) is a rapid and reproducible method for the enrichment of functional evs introduction: platelet-derived extracellular vesicles (pevs) represent the next generation of therapeutic biologics as they enable a more refined and targeted approach when compared to crude blood derivatives currently used for treating diseases such as cancer, thrombocytopenia and chronic wounds. however, development of an ev-based therapeutic is hindered by the lack of a scalable, validated and reproducible purification process. in this study, pevs were isolated from activated platelet concentrates and purified using exopharm's ligand-based exosome affinity purification (leap) technology to produce a functionally active ev therapeutic. methods: platelet concentrates (n = ) were obtained from the australian red cross blood service and were activated by exopharm's proprietary process. activation was verified by measuring cd p using flow cytometry. the resulting platelet releasate ( ml) was subjected to leap purification to isolate pevs. for characterization, protein concentration was determined by a bicinchoninic acid assay, microfluidic resistive pulse sensing (mrps) was used to perform a particle count and transmission electron microscopy (tem) enabled visualization of ev morphology. key ev markers were detected using mass spectrometry (ms) and western blots. to confirm biological activity, human dermal fibroblasts were subjected to serum starvation for hours before treatment with pevs ( µg/ml). cell growth was recorded by the real-time xcelligence system and differences in proliferation were statistically analysed using a one-way anova. results: mrps and tem both revealed isolated pevs to be - nm in size. the final product was positive for platelet markers (cd , cd p) and key ev markers (tsg , alix, cd ). treatment with purified pevs significantly increased proliferation in serumstarved fibroblasts over hours. summary/conclusion: exopharm's leap technology is a rapid and reproducible purification process which produces pevs that adhere to misev guidelines and are functionally active. funding: all funding was through exopharm ltd (asx:ex ) a novel but simple method to obtain purified exosomes by one-step ultracentrifugation introduction: exosomes are extracellular vesicles (evs) that are derived from endosome membrane. they are usually - nm in diameter, actively secreted in most living cells. originally, exosomes were thought to act as cellular garbage disposals. recent studies showed that exosomes not only can serve as biomarkers for diagnosis, but also can be used as an ideal delivery vehicle for drugs in therapeutics. exosomes are natural carrier for mrna, mirna, sirna, protein, dna and peptide for long distance intercellular communication. isolation of exosomes is challenging due to their small size and heterogeneity. traditional differential ultracentrifugation method is still the gold standard for exosome purification. to further explore the potentials of exosomes being as the therapeutic delivery vehicle or diagnostic reagent, it is an essential step to purify them in high quality at high yield. methods: here, we report a novel method to obtain intact shape, high-quality and high purity exosomes with one-step ultracentrifugation by using "exojuice". results: data of nanoparticle tracking analysis (nta) and western blotting showed "exojuice" can yield exosomes with a simpler method to obtain higher purity exosomes in comparison to previous method of cushion ultracentrifugation using optiprep. summary/conclusion: our method can be used to purify exosomes from cell culture medium, serum, urine, saliva, and other biofluids. a straightforward device to extract apoplastic fluid from succulent fruits for higher purity of extracellular vesicles introduction: edible plants are emerging as a sustainable source for extracellular vesicle (ev)-based drug delivery vehicles. however, current isolation methods (e.g. grinding or squeezing) may cause destruction of plants' biostructures, and in turn leads to unwanted effects in downstream applications and complicates the study of nanovesiclescell. therefore, we designed a simple device that allows the extraction of apoplastic fluid (af) from succulent fruits, facilitating ev isolation as well as effective downstream applications. methods: an inner filter tube was designed to extract af with a determined membrane pore size. af was collected by low-speed centrifugation method and then filtered to eliminate the impurities from the cytoplasm and damaged cells. minced juice (mj) was homogenized by a blender and then centrifuged to remove large fragments. subsequently, the differential centrifugation method was employed to extract evs from af and mj. fourier-transform infrared spectroscopy (ftir), nanoparticle tracking analysis (nta), and transmission electron microscopy (tem) were performed to discriminate af, mj and their evs. results: the "spectroscopic" protein-to-lipid (p/l) ratio of af ( . ± . ) is significantly lower than that in mj ( . ± . ), showing the higher lipid contents in af, which may result from the loss of lipids in mj obtained from grinding or juicing methods. similarly, ftir showed the difference in p/l ratio between af and its evs ( . ± . and . ± . , respectively). nta showed the sharper peak and smaller vesicle size in the following order: mj ( . ± . nm), af ( ± . nm), af-derived evs collected at , × g and , × g ( . ± . nm and . ± . nm, respectively). furthermore, tem study indicated that the collected evs exhibited a typical lipid bilayer of extracellular nanovesicles. summary/conclusion: by using a reusable filter device, we successfully isolated af from succulent fruits, paving the way to collect plant evs without an interference of significant biodestruction or damaged cells, hence improving the purity of evs and facilitating downstream applications. moreover, this method is straightforward, reproductive, and can be potentially used in a large-scale production. method to simultaneously capture multiple classes of intact extracellular rna carriers including extracellular vesicles and lipoprotein particles introduction: extracellular particles including extracellular vesicles (evs), lipoproteins, and free proteins are carriers of extracellular rna (exrna), which has been shown to regulate cellular function. because these particles have different physiological origins, they have different rna signatures, so the first step to understanding the biology of exrna is to isolate individual particle fractions with high purity and efficiency. current methods for isolating evs are optimized for increased yields and purity of ev fractions but typically require multiple millilitres of starting plasma and do not capture the other exrna carrier particle types. methods that can capture evs from low starting plasma volumes and can also capture other exrna carriers simultaneously are needed for analysing samples from previously conducted large cohort studies, biorepositories, and in populations where sample volume is limiting. methods: we have developed a method adapted from lipoprotein isolation that requires only µl of starting plasma, and uses brief ultracentrifugation (uc) followed by fast protein liquid chromatography (fplc) to capture classes of purified exrna carriers including evs, ldl, hdl, lipidated albumin, proteins, and vldl/chylomicrons. we have validated successful capture of evs by microfluidic resistive pulse sensing (mrps, spectradyne), transmission electron microscopy (tem), and single particle interferometric reflectance imaging system (sp-iris; exoview) with optional fluorescence. results: we have observed . × particles per ml from a ml fplc fraction of evs measured from , events by mrps, confirming that evs are being captured by this method. there were also . × particles/ml and . × particles/ml in the two subsequent ml fractions that are known to contain lipoprotein particles, though these were measured from , events each. by tem we confirmed these observations that evs are eluting before lipoprotein particles with some evs eluting later in fractions containing lipoproteins. summary/conclusion: these results confirm the efficacy of the method in isolating multiple exrna carrier fractions simultaneously from a single ul plasma sample, making it amenable for the analysis of exrna in samples from large cohort studies, biorepositories, and vulnerable populations such as the elderly and young children. funding: nih/nia r ag ; nih ug ca - optimizing the isolation of placental mesenchymal stromal cell-derived extracellular vesicles in a d bioreactor system leora goldbloom-helzner a and aijun wang baaaaa a uc davis, davis, usa; b uc davis medical center, sacramento, usa introduction: extracellular vesicles (evs) derived from placental mesenchymal stromal cells (pmscs) have the potential to provide neuroprotection at sites of injury. however, a rate limiting step in ev research is the low yield, high technical time, and high cost of current isolation procedures. to address this inefficiency, we cultured pmscs in a unique bioreactor system to increase the absolute yield of evs per ml of media and per cell. future studies will determine if this system can improve pmsc ev yield without altering the demonstrated neuroprotective properties of pmsc-evs. methods: pmscs were cultured in the bioreactor for ten weeks. ev-conditioned media was collected weekly and evs were isolated through differential centrifugation. nanoparticle tracking analysis (nta) measured ev size and concentration. western blots tested for normal ev markers (cd , cd , and cd , calnexin(-)) and enzyme-linked immunosorbent assays (elisa) measured levels of characteristic growth factors in conditioned media including vascular endothelial growth factor (vegf), brain-derived neurotrophic factor (bdnf), and hepatocyte growth factor (hgf). results: evs remained consistent until week eight, after which a decrease in both ev size and concentration was seen. western blots revealed normal positive expressions of cd , cd , and cd and negative expressions of calnexin. levels of vegf, bndf, and hgf were comparable after weeks. cost analysis revealed an overall increase in ev yield for shorter labour time and lower material cost. summary/conclusion: this initial study uses a bioreactor system for a unique source of cells and has brought us closer to optimizing pmsc ev isolation protocols for increased yield, lower cost and time commitment, and maintained sample purity. preliminary data suggests the ev phenotype and cell secretome are consistent with those present in current culture settings. future experiments will assess the preserved neuroprotective properties of the pmsc evs. a novel method for isolating extracellular vesicles from cell culture media and plasma using polyethylenimine introduction: due to their ability to transport dna, rna, and protein cargoes between cells, extracellular vesicles (evs) are becoming popular for biomarker discovery as well as for therapeutic delivery. here we describe the development of a novel precipitation method for the isolation of evs from cell culture media and plasma that is based on polyethylenimine (pei), an inexpensive, water-soluble, and biocompatible cationic polymer. pei is a group of hydrophilic cationic polymers that are synthesized as either linear or branched forms of varying molecular masses ( , to , da) and are widely used in the biomedical field as a coating and transfection agent. methods: linear and branched pei of varying molecular weights (mw) were tested for their ability to precipitate evs from either conditioned culture media (ccm) or human plasma. isolated evs were characterized by western blotting and nanoparticle tracking analysis (nta). the small rna profile of evs isolated using pei from human plasma was analysed by ngs and ev-specific mirnas were confirmed by digital droplet pcr (ddpcr). mass spectrometry (ms) was used to analyse the proteome of pei-captured evs from plasma. hek cells producing gfp+ evs were used to optimize conditions for release of evs from both linear and branched pei by fluorescent spectrophotometry and flow cytometry measure-ments. results: linear and branched pei were both able to precipitate evs as determined by western blotting for ev protein markers; however, branched pei with mw > , da and linear pei with mw > , da were more efficient for ev precipitation than lower mw forms. despite its known ability to bind nucleic acids pei was unable to capture cell-free dna from plasma, although rna and in particular ev-associated mirnas such as mir- - p were recovered. ms revealed that pei enriches extracellular exosome proteins from plasma. evs captured from ccm by pei could be released from the complex using heparin or high salt conditions. summary/conclusion: pei has an unexpected preference for associating with evs compared to nucleic acids in complex biological samples and has a hitherto unrecognized application for ev precipitation. introduction: there is ongoing debate about which is the most appropriate method for isolation of evs, with most labs using some combination of differential ultracentrifugation (uc), size-exclusion chromatography (sec), and/or density gradient ultracentrifugation (dg). here we applied a surface-enhanced raman spectroscopy (sers) analysis platform to compare chemical composition of the isolate from each method against lipoprotein standards to assess the relative purity of the ev preps. methods: - ml of plasma was separated from whole blood collected from head and neck cancer patients. each sample was split into batches and evs were isolated by either uc, sec, or dg. following isolation, samples were incubated on commercial sers substrates and raman spectra were collected. lipoprotein standards were purchased and also measured for comparison. using principle component analysis (pca), spectra were analysed for chemical variability. results: sers analysis of sec, uc, and dg isolated evs were chemically distinguishable using simple pca. the chemical changes could in large part be attributed to fitting the differences in spectra to lipoprotein standards. we found that uc isolated populations clustered with the high-density lipoproteins (hdl), sec populations with the low-and very low-density lipoproteins (ldl, vldl), and dg populations were more variable, but mainly clustered together with the highdensity-lipoproteins (hdl). summary/conclusion: this set of experiments matches our expectation that various lipoprotein would contaminate ev preps according to their relative size and density distributions. no single isolation method could separate pure ev samples. this study also illustrates the utility of label-free sers analysis for rapid chemical characterization of evs. bioreactors: lessons to develop an extracellular vesicle factory vanessa chang, priscila dauros-singorenko, lawrence w. chamley, colin l. the university of auckland, auckland, new zealand introduction: high density mammalian cell culture systems (bioreactors) provide valuable advantage for large scale production of secreted products such as extracellular vesicles (ev). however, optimisation of design selection, handling and operational costs can be quite challenging. here we provide our experience with a celline bioreactor system. methods: cultures of adherent cell lines were established in celline ad bioreactors and propagated for up to weeks. media was changed twice weekly and cells shed into serum-free conditioned medium were counted and assessed for viability. nanoevs were isolated by sequential centrifugation ( g - , g - , g) and size exclusion chromatography (sec). nanoevs were characterised in their protein (bca) and particle (nanoparticle tracking analysis) amount, ev markers (western blotting) and morphology (transmission electron microscopy, tem). results: the viability of shed cells varied between cell lines and through time, suggesting a changing dynamic during reactor establishment and continuous growth phases, that was specific to each cell line. hdfa, bt and bt consistently shed mainly dead cells ( - %), as opposed to mcf and mda-mb- which predominantly shed live cells. sec fractionation of nanoevs identified a dominate ev-rich peak and significant quantities of smaller proteins, highlighting the need for further purification. nanoev yields from each - day culture averaged - × particles, representative of yields obtained from cells grown in to conventional t tissue culture flasks. ev markers and tem confirmed the protein profiles and morphology of evs obtained from bioreactors. summary/conclusion: high density bioreactor cultures offer a physiologically relevant, cost and space efficient approach to produce significant amounts of evs, providing sufficient material for numerous experimental uses. in our hands, with careful twice weekly management, they can be propagated for up to weeks without significant changes to the evs. introduction: extracellular vesicles (evs) have potential applications for clinical theranostics. ultracentri-fugation is most commonly adopted to the evs isolation, which is recommended as a gold standard method. however, ultracentrifugation is time-consuming and expensive equipment requirement, resulting in the coisolation of contaminants such as protein aggregates. therefore, our aim is to develop a rapid and efficient platform to isolate heterogonous evs based on the insertion of lipid molecules into the evs membrane to avoid co-isolation of non-membranous protein particles. methods: herein, a defected nanoscale functional metal organic framework (mof) was constructed as an efficient platform for evs isolation. typically, one single-stranded dna was designed and modified with a phosphate group at the ʹ-end and cholesterol at the ʹ-end to form a capture dna named phosphate−dna−cholesterol (pdc). the phosphate group forms a strong covalent bond with the designed defeated site of zr (iv) in mof uio- -nh and the cholesterol inserts into the phospholipid bilayer to capture evs without non-membranous particles contamination. the formed mof−phosphate−dna −cholesterol−evs (mof@pdc@evs) system was further treated with dnase i for dna hydrolysis to give high pure evs. results: a rapid and efficient isolation platform of evs based on a defected mof functionalized with phosphate-dna-cholesterol (mof@pdc) has been constructed successfully. compared with ultracentrifugation, mof@pdc platform promises to isolate size heterogeneous evs i) without non-membranous particles contamination, maintaining evs intact membrane structure, protein components, and biological functions; ii) with the ability to capture evs with % isolation efficiency; iii) makes evs isolation process simple and fast, which could be finished in minutes without requirement of the expensive equipment. summary/conclusion: in conclusion, this rapid and efficient platform is suitable for isolation evs from biological fluid for downstream protein analysis. this work opens a new perspective in mof-based separation researches and may shed light on further studies towards evs isolation. introduction: incorporation of pharmacologically active molecules on the surface or the lumen of extracellular vesicles (evs) is an important strategy for maximizing the therapeutic potential of evs. genetic engineering of producer cells by introducing dna through random or site-specific integration are promising strategies for creating engineered evs. longterm stability with consistent transgene expression in the ev producer cells and therapeutic potency of resulting engineered evs are crucial for biomanufacturing. we present a comprehensive study to investigate stability of transgene expression and potency of two potential therapeutic engineered evs derived from stably selected pools transfected by either random integration (ri) or site-specific integration (ssi). methods: producer cells were engineered to make evs displaying interleukin (il ) or interferon gamma (ifng) by ri or nuclease-mediated ssi into aavs locus. following puromycin (puro) selection, longterm cellular stability and transgene expression without selective pressure was investigated. evs were generated from stable cell pools at , , and months post-thaw and purified by density gradient ultracentrifugation. purified evs were biochemically characterized by nta, bca, western blot, and cholesterol quantitation. transgene expression and biological activity of evs displaying il and ifng were assessed by alphalisa and in vitro reporter assays. results: transfection by ssi resulted in faster recovery in puro selection compared to ri. all stable cell pools, regardless of integration method, resulted in comparable cell culture performance, ev yield, and lipid and protein content at all time points tested. the engineered evs also demonstrated long-term stability of il and ifng transgene expression and in vitro activity from both integration strategies. summary/conclusion: both methods for generating stable cell lines were comparable in terms of cell stability, transgene expression, ev titre and potency, with ssi having the advantage of speed, allowing for more rapid iteration cycle times. thus, both methods are suitable for the precision engineering of therapeutic evs. this work demonstrates feasibility to manufacture therapeutic engineered evs from stable cells from either integration strategy for clinical development. transport of outer membrane vesicles as a model therapeutic delivery system in pathogenic and commensal bacteria introduction: outer membrane vesicles (omvs) in gram-negative bacteria have been shown to be important carriers of biomolecules, including toxins and other virulence factors, peptidoglycan, and nucleic acids. it has been shown that omvs play an important role in the delivery of these biomolecules to host cells and bacterial cells. while many thorough studies have explored omv delivery to host cells, few studies have explored the mechanisms of delivery of omvs to bacterial cells. our goal was to study the delivery of omvs to other bacterial cells. specifically, we were studying the oral pathogen aggregatibacter actinomycetemcomitans (a.a.), a gram-negative organism associated with localized aggressive periodontitis, to study the process by which vesicles from this organism communicate with other bacterial cells. overall, we want to understand the roles specific surface components of omvs play in the transport of these omvs to other bacterial cells. methods: we studied omvs from two strains of a.a.: jp , a highly pathogenic strain, and , a natural commensal strain. af -labelled omvs were incubated with fresh bacterial cultures. association of the omvs with the bacterial cells was quantified using flow cytometry. to examine the role of surface-associated dna in this process, dna was digested with dnase, and the amount of surface-bound dna was quantified with the membrane impermeable dna stain, toto- . results: using flow cytometry, we observed jp omvs were delivered to , cells, and at a lesser amount to jp cells. alternatively, , omvs associated readily with jp cells, more than to , cells. this suggests that the delivery of omvs to bacterial cells may be a targeted delivery mechanism. furthermore, we hypothesized surface-associated dna may play a role in this interaction. we next digested the surface-associated dna on the omvs with dnase, and observed a decrease in association between the omvs and bacterial cells. this supports our hypothesis that dna on the surface of the omvs plays a role in association. current experiments are investigating this interaction in more detail. summary/conclusion: we have demonstrated that omvs are selectively delivered to bacterial cells, and surface-associated dna plays a role in this process. we propose to investigate this process to further understand omvs delivery to bacterial cells. funding: r de & r de . utilizing a gaucher's disease cell line for the evaluation of a novel exosome-based replacement therapy annie k. brown a , jiayi zhang b , brendan lawler b and biao lu b a santa clara university, san jose, usa; b santa clara university, santa clara, usa introduction: engineered nano-scale exosomes have great potential as new and targeted delivery vehicles for the treatment of gaucher's disease, the most common lysosomal storage disease. recently, we have reported the design, production, and isolation of exosomes loaded with lysosomal β-glucocerebrosidase (gba). people suffering from gaucher's disease do not have functional gba, which results in toxic build-up of undegraded substrates within the cell. methods: to evaluate the efficacy of this exosomebased therapy, a human gaucher's disease model is required. here, we have utilized near-haploid human cells (hap ) modified via crispr-cas to model gaucher's disease in vitro. these cells contain a bp insertion in the th exon of the gba gene, resulting in non-functional gba. pcr, enzyme activity assays, and flow cytometry have been employed to confirm the diseased genotype and phenotype. results: characterization of gba-knock out cells shows a total loss of gba enzyme activity. further characterization demonstrates a normal growth rate but an increased number of lysosomes, indicating a diseased phenotype. summary/conclusion: the utilization of a human gba-knock out cell line will enable the evaluation of the efficacy of our engineered exosomes. disease models will be an important resource for the evaluation of new biologic therapeutics, including exosomes. funding: we would like to acknowledge the santa clara university school of engineering for their support. thrxosomes: a novel exosomes based theranostic for lung cancer introduction: chemotherapy is the first-line of treatment for lung cancer. however, inefficient bio-distribution and reduced accumulation of drugs in the tumour results in treatment failure. therefore, improved drug delivery and diagnostic systems are warranted. herein, we propose a novel theranostic system "thrxosomes" where exosomes are loaded with super paramagnetic iron nanoparticles (spions) conjugated to an anticancer drug via a phresponsive linker for controlled release. we hypothesize that thrxosomes will exert profound anticancer tumour activity that can be concurrently be monitored by magnetic resonance imaging (mri). methods: thrxosomes were produced by combining normal human lung fibroblast (mrc ) cell-derived exosomes with spions conjugated to and anti-cancer drug (chemodrug or mirna) via a ph cleavable linker. the physical and biological properties of thrxosomes were determined using transmission electronic microscopy (tem), nanotracker-analysis (nta), inductively coupled plasma mass spectrometry (icpms), western blotting, cell viability, and mri. results: exosomes used in preparing thrxosomes were nm in size with a typical lipid bilayer structure, and were positive for cd , cd , flotillin and negative for annexin a confirming presence and purity of exosomes. charge analysis, tem, and icmps data showed successful loading of spion-drug conjugate. biological studies showed selective and enhanced drug release under acidic condition (ph . ) compared to drug release at ph . . cell uptake and viability studies demonstrated increased uptake and killing of thrxosome-treated human a lung cancer cells compared to mrc- cells. in vivo studies demonstrated accumulation and detection of spions by mri in in-situ tumours of a tumour-bearing mice. summary/conclusion: our study demonstrates thrxosomes will produce profound anticancer activity in lung cancer that is measurable by mri. exosome-modified nanoparticles as an alternative delivery system for small rnas in cancer therapy petro zhupanyn a , alexander ewe b , thomas büch c and achim aigner a a independent division for clinical pharmacology at rudolf-boehm-institute for pharmacology and toxicology, faculty of medicine, university of leipzig, germany, leipzig, germany; b dr., leipzig, germany; c rudolf-boehm-institute for pharmacology and toxicology, faculty of medicine, university of leipzig, germany, leipzig, germany introduction: gene knockdown by rna interference (rnai) is an alternative, non-invasive method for inhibiting proliferation or promoting apoptosis in tumour cells. this technique allows the specific targeting of key signalling proteins or mutated genes. most of the available transfection compounds suffer from rather profound cytotoxicity in vitro. the aim of our study was to establish a novel targeted small nucleic acid delivery system to the cells, with good cellular biocompatibility and applicability for in vivo studies. for this aim, we used native, cell own vesicles-exosomes. since exosomes are known to transport peptides and different rnas between cells and tissues, these unique, small extracellular vesicles (ev) may also be useful as transport vehicles for therapeutic sirna. methods: as detected by multiple cell surface protein expression analysis, exosomes carry specific surface expression markers, allowing the cellular uptake by the most of tissues. we established an ev purification protocol from tumour cell culture supernatants and a strategy for the efficient ev loading with our test sirnas or antimirs. here we used the combination of polyethylenimine (pei)-complexation of the rnas with ultrasound treatment for their loading into the evs. our ev-modified, ultrasound-treated nanoparticles were tested in vitro by measuring knockdown efficacies in luciferase reporter cell lines or by rt-qpcr gene expression analysis. results: more efficient cellular sirna uptake was observed upon ev-modification of our pei/rna nanoparticles, accompanied by efficient inhibition of gene expression. biological efficacies were retained also after storage for several days at room temperature. the monitoring of the ev-based particles by facs revealed a different time resolution of cellular uptake and nucleic acid release compared to the classically formulated peinanoparticles. in an in vivo therapy study in tumour xenograft-bearing mice, high biocompatibility, significant biological knock-down and tumour inhibition were observed after injection of anti-survivin sirnas formulated in our ecv-modified pei nanoparticles. summary/conclusion: our data demonstrate the usability of ecv-modified nanoparticles as efficient delivery system for small rnas in cancer therapy. microglial extracellular vesicles as therapeutic vector for neuroinflammation giulia marostica a , annamaria finardi b and roberto furlan a a san raffaele scientific institute, milan, italy; b san raffaele scientific institute, milan, italy introduction: microglia is considered an eligible target against the progressive multiple sclerosis (ms), but currently available therapies do not allow its efficient targeting. as many cell types, microglia communicate with the neighbouring cells through a complex system of extracellular vesicles (evs) exchange. recently my group described that microglia derived-evs, engineered to encapsulate il , are taken up by microglia itself, mediating a phenotype switch to a protective phenotype. in vivo studies suggest that these evs can ameliorate established neuroinflammation, thus making them a promising drug-delivery tool to target cns in ms. my project focuses on understanding the mechanism of action and the signalling pathway of evs delivery and to exploit this knowledge to specifically deliver different potential therapeutic molecules. for this purpose, we decided to characterize the evs through trps technology. methods: a murine microglia cell line (bv ) was engineered to stably overproduce endogenous il . this cell line was cultured in exosome-depleted rpmi and stimulated with pma( mg/ml) for min. evs isolation was carried out by collecting supernatant and subjecting it to consequential centrifugation of g, min, rt and g, min, °c. the resulting supernatant was filtered ( µm) and ultracentrifuged at , g for h at °c. the evs pellet was re-suspended in ice-cold pbs. the evs analysis with trps shows two populations of evs, one with a mean diameter of - nm and a broad zeta potential ranging from − mv to − mv, while the second population has a mean diameter of - nm and a zeta potential of − /- mv. this difference can be consistent with the different pathway formation of exosomes and microvesicles. we demonstrated in vivo the strong phenotypic change induced by our evs to resting microglia in a dose-and time-dependent effect. then, impairing the physiological procedure of the endosome acidification, the effect of our evs on recipient cells is higher. thus, suggesting an endocytic pathway for the internalization of the vesicles. we further demonstrate with gradient ultracentrifugation the capability of our formulation to vehicle endogenous il inside the vesicles. even if some protein is co-purified in the procedure, we know that the half-life of this cytokine is too short to elicit a strong in vivo response. consequently, we assume that the anti-inflammatory effect of our evs in vivo is a result of the il internalized in our formulation. summary/conclusion: these data help us understand more in detail the process of internalization and phenotype change mediated by these evs. our next goals are to discriminate between different internalization pathways and further validate the efficacy of our therapy on the eae mouse model. targeting il- rα on tumour-derived endothelial cells blunts metastatic spread of triple negative breast cancer via extracellular vesicle reprogramming introduction: the lack of an approved targeted therapy and the early onset of metastasis highlight the need for new treatments for triple-negative breast cancer (tnbc) patients. interleukin- acts as an autocrine factor for tumour-endothelial-cells (tec), and exerts pro-angiogenic paracrine action via extracellular vesicles (nevs). il- rα blockade on tec changes tec-ev (anti-il- r-evs) microrna cargo and promotes the regression of established tumour vessels. as tec are the doorway for "drug" entry into tumours, we have aimed to assess whether il- r blockade on tec impacts tumour progression via their unique ev cargo. methods: human tnbc samples, mda-mb- , mda-mb- and mcf cell lines were evaluated for the expression of il- rα. nevs and anti-il- r-evs were characterized by electron-microscopy, macsplex-exosome-kit and western blot. proliferation, migration, apoptosis and sphere formation were evaluated. scid mice were used for in vivo experiments. results: we noticed that, besides tec and inflammatory cells, tumour cells from . % of the human tnbc samples expressed il- rα. mda-mb- and mda-mb- , but not mda cells, expressed il- rα. in vitro, nevs provide survival and migratory signals, while anti-il- r-evs promoted apoptosis as well as reduced cell viability and migration of human tnbc cell lines. in vivo anti-il- r-ev treatment induced vessel regression in established tumours formed of mda-mb- cells and almost abolished the spread of liver and lung metastasis. moreover, decreased β-catenin and twist were found in tumours from animals treated with anti-il- r-evs. in addition, anti-il- r-evs reduced lung metastasis that was generated via the intravenous injection of mda-mb- cells. nevs that were depleted of mir- - p (antago-mir- - p-evs) were effective as anti-il- r-evs in down-regulating twist and reducing lung-vessel density and metastatic lesions in vivo. summary/conclusion: overall, these data provide the first evidence that il- rα is highly expressed in tnbc cells, tec and inflammatory cells, and that il- rα blockade on tec impacts tumour progression. introduction: high-grade serous ovarian cancer (hgsoc) is the deadliest gynaecologic cancer. its lethality is explained for late diagnosis at advanced stages and frequent recurrences despite achieving complete response with standard therapy. most of recurrences occurs at abdominal cavity with multiple metastasis. therefore, identifying key determinants of metastatic process remains as priority to find better therapies. current evidence assigns a central role of the exosomes in conditioning the metastatic niche in epithelial cancers. recently, we demonstrated that statins reduce metastasis in hgsoc in preclinical models. here, we decided to study the effects of statins on hgsoc-derived exosomes and its capability to condition the metastatic niche. methods: exosomes were isolated from heya ovarian cancer cell line and primary tissue cultures established from advanced-stage hgsocs (with signed informed consent and irb approval) by differential ultracentrifugation and quantified by nanoparticle tracking analysis (nta). enriched-cancer initiating cells (cic) spheroids were established from heya cells by using stem-selecting conditions. the paracrine effect of exosomes on cic migration/invasion was studied using either d migration or boyden chamber invasion assays. previous to exosome isolation, heya cells were treated with simvastatin ( um, h) or solvent and proteins involved in exosome biogenesis/uptake (alix, tsg ), its trafficking (rab a, rab a) and in conditioning the metastatic niche (emmprin) were measured by immunoblotting. results: exosomes isolated from heya cells or hgsocs enhance the metastatic potential of heya established spheroids in d migration or boyden chamber invasion assays. upon simvastatin treatment, we observed a significant reduction in migration/invasion induced by equivalent number of exosomes in heya -derived cics. under same treatment, we observed a significant decrease in protein levels of alix and tsg and an increase in the inactive forms of rab a and rab a in heya cells. we also observed a decrease in emmprin levels in heya -derived exosomes. summary/conclusion: here, we demonstrated a paracrine effect of hgsoc-derived exosomes that favour the metastasis process. in addition, we demonstrated that simvastatin reduces metastasis induced by cancerderived exosomes. such an effect is partially explained by changes in the expression of proteins involved in exosome biogenesis/uptake, its endocytic trafficking and in the content of proteins conditioning the metastatic niche. thus, simvastatin arises as potential therapeutic target to improve outcomes in this disease. funding: this research was supported by fondecyt granted to mauricio a. cuello label-free optical imaging and characterization of cancer-associated extracellular vesicles in tissues introduction: cancer-associated extracellular vesicles (evs) visualized in the tumour microenvironment have been identified as a potential biomarker for cancer-related tissue changes. analyses of evs have traditionally been performed in cells or isolated evs, with no temporal or spatial information that could be critically important for elucidating their roles in carcinogenesis. since the unperturbed distribution and organization of evs in the tumour microenvironment is associated with their cellular function and can potentially serve as a diagnostic and prognostic biomarker, there is a strong need for visualizing evs in freshly isolated tissue specimens. currently, only fluorescent labelling methods enable visualization and tracking of evs. we used a custom label-free multimodal multiphoton optical imaging system to detect and characterize evs and classify them using their optical signatures both in isolated tissues and in situ tumours. methods: label-free multimodal multiphoton imaging was used to provide simultaneous, co-registered structural and functional images of evs in untreated samples. heterogeneous populations of evs could be identified from their unique optical signatures. results: the intrinsic metabolic and structural properties of evs enabled reliable visualization and optical characterization of evs from cell cultures and in situ imaging of tumour-bearing rats. unique optical signatures were then used for identification of cancer-related evs in tissues from human breast cancer patients, and their density was found to be highly correlated with clinical diagnosis. in the current study, evs were isolated from urine of tumour-bearing dogs, and urine and serum from breast cancer patients. analysis of ev content showed higher concentration of nad(p)h in evs isolated from cancer subjects, than from healthy subjects, which reflects the reprogramming of cellular metabolism in carcinogenesis. summary/conclusion: these results suggest a potential label-free optical methodology to detect and characterize evs by their optical signatures, which can be utilized as possible diagnostic and prognostic biomarkers for cancer. funding: this research was conducted under protocols approved by the iacuc and irb at the university of illinois and carle foundation hospital, and supported by funding from nih. novel potential anticancer therapies based on interference with nuclear entry of cancer cell-derived extracellular vesicle components in recipient cells introduction: the intercellular communication mediated by extracellular vesicles (evs) in the tumour microenvironment plays an important role in tumour progression. experimental evidence indicates that evs derived from highly metastatic cells influence the behaviour of less aggressive cancer cells. we have previously described a novel intracellular pathway where a fraction of endocytosed ev-associated proteins and nucleic acids is transported into the nucleoplasm of the host cell via a subpopulation of late endosomes penetrating into nucleoplasmic reticulum (nr). here, we better characterize this pathway and report that it is required for the induction of an aggressive behaviour induced by evs released from highly metastatic sw colon cancer cells in isogenic primary cancer cells. methods: super resolution-structured illumination microscopy and magnetic-based co-immunoisolation studies were employed to identify the protein components of the nuclear pathway and to monitor the entry of ev-containing late endosomes into the nucleoplasmic reticulum. human sw carcinoma cells expressing er-gfp and rab -rfp were exposed to evs from sw cells and then live imaged. results: we have previously reported that the tripartite protein complex, containing vap-a, orp and rab orchestrates the localization of ev-carrying late endosomes into nr. we now report that silencing of orp or vap-a, but not its homologue vap-b, reverses the pro-metastatic changes induced by evs isolated from metastatic cells on their non-metastatic counterpart, including transition to an ameboid phenotype, cell rounding and blebbing. moreover, we found that certain nuclear pore complex proteins and importin-beta are co-immunoisolated with orp , vap-a and rab suggesting the formation of a large protein complex at the entry of nuclear pores. summary/conclusion: interfering with the mechanisms regulating this novel intracellular pathway may find therapeutic applications particularly in ev field and oncology. educated osteoblasts regulate breast cancer proliferation via small extracellular vesicles thomas jefferson university, philadelphia, usa introduction: breast cancer commonly traffics to bone, where breast cancer cells (bccs) can survive undetected for years before metastatic outgrowth. in bone, bccs interact with surrounding stromal cells, including osteoblasts (obs), to shape the metastatic niche. our lab discovered there are at least two subpopulations of obs in the bone-tumour niche, based on protein marker expression. one group, "educated osteoblasts" (eos) have engaged in crosstalk with bccs whereas another group, naïve obs, have not. we have novel evidence that eos regulate bcc proliferation. the purpose of this study was to determine if extracellular vesicles (evs) produced by eos play a role in regulating bcc proliferation. we hypothesized evs produced by eos would decrease bcc proliferation. methods: eo-derived small evs from culture media were isolated via ultracentrifugation and characterized evs for size, protein marker expression, and density floatation to validate the purity of ev samples. the functionality of eo-derived evs on bcc proliferation was examined using edu and checkpoint proteins p and p . bcc protection from chemotherapy induced cell death was also examined. results: we found that evs produced by eos, but not naïve obs, decreased both triple negative and erpositive bcc proliferation in a concentration dependent manner. furthermore, using an edu assay, we found that exposure to eo-derived evs induces bccs to undergo cell cycle arrest. interestingly, the cell cycle arrest was reversible and bcc proliferation was restored upon removal of eo-derived evs. in addition, exposure to eo-derived evs leads to increases in bcc expression of the g checkpoint proteins, p and p . we next wanted to investigate proliferative signalling pathways that may be deregulated in bccs following exposure to eo-derived evs. we found that eoderived evs reduce bcc levels of erk / . because our data indicate eo-derived evs induce sustained cell cycle arrest in bccs, we desired to know if eo-derived evs protected bccs from chemotherapy-induced cell death. we found that bccs exposed to eo-derived evs and the chemotherapy drug, doxorubicin, have decreased cell death compared to bccs exposed only to doxorubicin. summary/conclusion: altogether, our data suggest eos play a crucial role in bone-tumour microenvironment by regulating bcc proliferation. funding: supported by nih r ca and commonwealth of pennsylvania -department of health sap for kmb. phosphorylation of tyrosine in annexin a is essential for its association with exosomes and for imparting invasive and proliferative capacity to other cells priyanka prakash desai a , pankaj chaudhary b , xiangle sun b and jamboor vishwanatha a a unt health science center at fort worth, fort worth, usa; b unt health science center, fort worth, usa introduction: triple negative breast cancer (tnbc) accounts for %- % of all breast cancer cases. the lack of targeted-based therapies highlights the importance of studying tnbc. elevated levels of annexin a (anxa ), a ca+ -dependent phospholipid binding protein, has been correlated with worse overall survival in tnbc patients. our previous data implicate that exosomal anxa is involved in creating a pre-metastatic niche and facilitating metastasis in tnbc. moreover, n-terminal phosphorylation of tyrosine (tyr) in anxa has been implicated in regulating several anxa activities in cancer progression. here, we demonstrated that n-terminal phosphorylation of anxa at tyr is important for its association with exosomes which imparts invasive and proliferative phenotype to other cells. hence, dissecting the regulatory pathway will be critical for verifying the value of anxa as a therapeutic, diagnostic or prognostic marker in tnbc. methods: pn -egfp plasmids expressing the constitutive phosphomimetic (anxa -y e) and non-phosphomimetic mutant (anxa -y f) gene expressing mutation at tyr site were overexpressed in mda-mb- tnbc cells. mutant cells were experimentally validated for anxa specific functions like migration, invasion and proliferation. exosomes were isolated from the mutant phosphomimetic (exo-anxa -y e-gfp) and non-phosphomimetic (exo-anxa -y f-gfp) cells and were analysed for exosomal surface expression of anxa by immunoprecipitation and flowcytometry. cal- breast adenocarcinoma epithelial cells were treated with exo-anxa -y e-gfp and exo-anxa -y f-gfp to analyse the rate of invasion and proliferation by transwell invasion and proliferation assay, respectively. transfer of exosomal anxa in cal- was studied using immunofluorescence and its implications on signalling pathways were studied by western blot. results: mda-mb- phosphomimetic tnbc mutant cells showed increased migratory, invasive and proliferative capacity compared to non-phosphomimetic tnbc mutant cells. exo-anxa -y e-gfp had elevated surface anxa expression compared to exo-anxa -y f-gfp. cal- cells treated with exo-anxa -y e-gfp showed high migratory, invasive and proliferative characteristics, with a higher expression of p-anxa (tyr ), p-src(tyr ) and p-paxillin(tyr ) compared to exo-anxa -y f-gfp treated cells. summary/conclusion: n-terminal phosphorylation of tyr in anxa in mda-mb- tnbc cells (phosphomimetic mutant cells) is essential for its association with exosomes and for conferring increased invasive and proliferative capacity to other breast cancer cells. funding: the above study is funded by national institute of health ro ca and nimhd's u md to dr.j.k.vishwanatha. a novel method for epithelial-derived extracellular vesicle isolation and enrichment in patients with advanced prostate cancer arpit rao, helene barcelo and bharat thyagarajan university of minnesota, minneapolis, usa introduction: evaluation of changes in prostate cancer biology is difficult due to presence of lymph nodal or bony metastatic disease in a majority of patients. a number of liquid biopsy assays have shown clinical utility in prostate cancer, but are limited by low sensitivity (e.g. circulating tumour cells-based assays) or inability to perform transcriptome sequencing (cellfree dna-based assays). epithelial-derived extracellular vesicles (epi-ev)-based assays are uniquely positioned overcome both these limitations as evs are abundantly secreted into the blood and have rnacargo that mirrors the cell of origin. however, a reliable method to enrich for epi-evs is currently lacking. methods: plasma was isolated from the peripheral blood collected from patients with metastatic prostate cancer enrolled in an institutional biobanking study before initiation of systemic antineoplastic therapy. evs were isolated from µl of plasma using a commercially available qev size exclusion column (izon inc.). without subjecting the evs to any physical stressors such as centrifugation, cd magnetic beads were used to fractionate the evs into cd + (platelet derived) and cd -(non-platelet derived) fractions. multiparameter flow cytometry was used to evaluate evs that expressed cd and epcam and were negative for calnexin. nanotracking analysis (nta) was used to quantify both total ev and cd + and cd fractions in all patient samples. the average ± standard deviation of total evs obtained from the patients was . x ^ ± . x ^ evs/ml of plasma (coefficient of variation [cv] : %) while the average and standard deviation of cd -evs was . x ^ ± . x ^ (cv: %). the cd -ev fraction represented a variable amount of the total evs in prostate cancer patients ranging from . % to . %. multiparameter flow cytometry showed that over % of total evs were cd + and calnexin-, suggesting an endosomal origin for a vast majority of the evs in these plasma samples. however, the proportion of evs expressing epcam (marker of epi-evs) was higher among the cd -fraction ( % - %) as compared to the cd + fraction ( . % - %). summary/conclusion: our novel method was able to isolate and enrich the epi-ev from the plasma of advanced prostate cancer patients. correlation between clinical characteristics and ev quantity is being evaluated to identify the reason(s) for large variations in cd -ev fraction. future studies are planned to use our method in improving the sensitivity of ev-based assays and increase the rna yield to facilitate transcriptome sequencing. funding: this work was funded by grants from randy shaver community and research fund, minnetonka, mn. exosomes drive medulloblastoma metastasis in a mmp and emmprin dependent manner introduction: recurrent/metastatic medulloblastoma (mb) is a devastating disease with an abysmal prognosis of less than % -year survival. the secretion of extracellular vesicles (evs) has emerged as a pivotal mediator for communication in the tumour microenvironment during metastasis. the most investigated ev's are exosomes, nanovesicles secreted by all cell types and able to cross the blood-brain-barrier. matrix metalloproteinases (mmps) are enzymes secreted by tumour cells that can potentiate their dissemination by modification of the extracellular matrix. we hypothesise that exosomal mmp and its inducer emmprin could enhance metastasis of mb. methods: proliferation, invasion and migration assays were used to evaluate the phenotypic behaviour of primary cell lines pre-treated with metastatic tumour cell-derived exosomes. gelatin zymography and western blotting were performed to confirm mmp functional activity in cell lines and exosomes. nanoscale flow cytometry was used to measure surface exosomal emmprin levels. exosomal mmp and emmprin were modulated at the rna level. results: number of exosomes is directly related to the migratory behaviour of parental mb cell lines (p < . ). notably, functional exosomal mmp and emmprin levels also correlate with this. furthermore, exosomes from metastatic cell lines conferred enhanced migration and invasion on their matched isogenic primary (non-metastatic) cell line pair bỹ . -fold (p < . ). exosomes from metastatic cell lines also conferred increased migration on poorly migratory foetal neuronal stem cells. summary/conclusion: together this data suggests that exosomal mmp and emmprin may promote medulloblastoma metastasis and supports analysis of exosomal mmp and emmprin levels in patient cerebral spinal fluid samples. introduction: exosomes secreted from cancer cells harbour the potential to regulate intracellular signalling and promote metastasis. wherein, metastasis suppressor genes (msgs) play a pivotal role in regulating such signalling cascades. however, the regulation gets hampered due to low expression of msgs under metastatic conditions. nm -h , product of first identified metastasis suppressor gene nme , is significantly downregulated under metastatic conditions. nm -h serves as a regulator of small gtpases. several evidences have highlighted an involvement of small gtpases (such as rab , rab and rab ) in the biogenesis of exosomes. in addition, bacterial homolog of nm has been shown to interact with rab and rab . however, experimental evidence supporting a relationship between exosomes and nm -h is lacking. our current focus is to deduce the relationship between exosomes and msgs. methods: breast cancer cell lines were used to assess the effect of exosomes isolated from highly metastatic cells (mda-mb- cells) on lower/non metastatic cells (mcf- cells). nme was overexpressed in mda-mb- cells and subsequently used to isolate exosome fractions. equivalent amount of isolated exosome fractions from mda-mb- cells and mda-mb- /nme cells were utilized to access their effect on migration and difference in exosome markers. results: we observed an enrichment of nm -h in the exosomes isolated from mda-mb- cells upon overexpression of nme . proteinase k protection assay confirmed the packaging of nm -h inside the exosomes isolated from mda-mb- /nme cells and excluded the possibility of membrane association of nm -h . additionally, overexpression of nm -h led to a significant reduction in the ability of mda-mb- exosomes to stimulate movement of mcf- cells as confirmed by wound healing assays. our data also highlights a clear reduction in the protein levels of exosome markers such as cd , cd and alix in the exosome fraction isolated from mda-mb- /nme cells as compared to mda-mb- cells. interestingly, rab a, a protein involved in the endosome-lysosome fusion was also present in lower amount in the exosomes isolated from nm -h overexpressing cells. summary/conclusion: our data highlights an antimigratory effect of nm -h via exosomes. these findings support a regulatory role of nm -h in the packaging or release of exosomes in highly metastatic breast cancer cells, and further suggest that metastasis suppressor proteins may be involved in the regulation or packaging of exosomes. additional studies will be required to decipher the downstream signalling of nm -h which affects the biogenesis of exosomes as well as to assess the effect of nm -h overexpression on the content of exosomes. these insights could help us delineate the complex exosome biogenesis pathway and provide new potential drug targets for exosome regulation. introduction: exosomes (exs) are emerging as novel players in the beneficial effects induced by exercise on vascular diseases. our recent study has revealed that moderate exercise enhances the function of circulating endothelial progenitor cell-derived exosomes (cepc-exs) on protecting endothelial cells against hypoxia injury. in this study, we aimed to investigate whether exercise-regulated cepc-exs contribute to the beneficial effects of exercise on ischaemic stroke (is). methods: c bl/ mice performed moderate treadmill exercise ( m/min, -wks) before is induced by middle cerebral artery occlusion surgery. acute injury was evaluated at day by determining neurologic deficit, infarct volume, cell apoptosis in the penumbra and neurologic recovery was assessed by determining angiogenesis/neurogenesis, sensorimotor functions at day . the correlations of cepc-exs and their carried mir- with neurological parameters were analysed. the underlying mechanism of the effects of cepc-exs isolated from exercised mice was explored in a hypoxia neuron model. cellular mir- level, apoptosis, axon growth ability and gene expressions (cas- , bdnf and akt) were measured. results: ) exercised mice had a smaller infarct volume on day , which was associated with decreased cell apoptosis and cleaved cas- level, and a higher microvessel density than those in control; ) the elevated cepc-ex level positively correlated with tepc-exs in ischaemic brain of exercised mice on day . the upregulated mir- level positively correlated with the numbers of tepc-exs in ischaemic brain; ) the numbers of cepc-exs and their carried mir- level negatively correlated with the infarct volume, cell apoptosis and positively correlated with the microvessel density in the peri-infarct area on day ; ) exercised mice had decreased infarct volume, increased microvessel density, promoted angiogenesis/neurogenesis and improved sensorimotor functions on day , accompanying with upregulated levels of bdnf, p-trkb/trkb and p-akt/akt; ) cepc-exs of exercised mice protected neurons against hypoxia-induced apoptosis and compromised axon growth ability which were blocked by mir- and pi k inhibitors. summary/conclusion: our data suggest that the protective effects of moderate exercise intervention on the brain against mcao-induced ischaemic injury are ascribed to cepc-exs and their carried mir- . funding: this work was supported by american heart association ( post ) and nih ( r ns ). syndecan- regulates alveolar type epithelial cell senescence mediating through extracellular vesicles during lung fibroproliferation tanyalak parimon a , changfu yao a , adam aziz a , stephanie bora a , marilia zuttion zuttion a , dianhu jiang a , melanie koenigshoff b , cory hogaboam a , paul nobel a , barry stripp a and peter chen a a cedars-sinai medical center, los angeles, usa; b university of colorado, denver, usa introduction: alveolar type epithelial cell (at ) senescence is implicated in the pathogenesis of lung fibrosis, a progressive fatal condition. syndecan- , a heparan sulphate proteoglycan, is overexpressed by at cells of human idiopathic pulmonary fibrosis (ipf) and bleomycin-injured wt mice and the overexpression of syndecan- is profibrotic. moreover, syndecan- deficient (sdc -/-) mice had less lung fibrosis after bleomycin injury. we reported that extracellular vesicles (evs) in bronchoalveolar lavage (bal) of bleomycin-injured wt mice augmented lung fibrosis whereas the sdc -/--bal-evs attenuated the process. moreover, wt-bal-evs expressed lower level of anti-fibrotic mirnas (mir- b- p, − - p, − - p, and − - p) compared to the sdc -/-bal-evs. these mirnas targeted genes in the cellular senescence pathway indicating that syndecan- altered microrna profiles in the bal-evs to promote cellular senescence during lung fibrogenesis. we investigate how syndecan- regulates at senescence through evs. methods: bleomycin was intratracheally given into wt and sdc -/-mice. at day , lungs were processed for single-cell rna sequencing (scrnaseq) and western blot (wb). evs were isolated using ultrafiltration centrifugation method. human (a ) and mouse (mle- ) lung epithelial cell lines were used for in vitro experiments. results: scrnaseq analysis indicated while bleomycin stimulated an overexpression of cellular senescencespecific genes on at cells of wt mice, these genes were significantly downregulated on sdc -/-at cells. senescence proteins, p and p , were also less expressed in the lungs of sdc -/-than of the wt mice by wb. to determine the functional effects of evs in bal, a cells were treated with human ipf or control lung wash-evs and evaluated for beta-galactosidase activity. we found that ipf-evs markedly increased beta-galactosidase enzymatic activity. corroborating with these data, bleomycin-injured bal-wt-evs also significantly upregulated senescence marker, p , by wb on mle cells whereas sdc -/--bal-evs inhibited p expression. summary/conclusion: our data indicate that syndecan- regulates lung fibrosis through the senescence signalling pathway on at cells. furthermore, syndecan- controls at senescence mediating through extracellular vesicles in the bal. lastly, the most likely cargo molecules mediating this process are micrornas. immortalized cardiosphere-derived cell ev-associated pirna, imev-pi, protects against ischaemic injury in the heart alessandra ciullo, ahmed ibrahim, liang li, chang li, weixin liu and eduardo marbán smidt heart institute, cedars sinai medical center, los angeles, usa introduction: cardiosphere-derived cells (cdcs) are a population of heart-derived progenitors with demonstrated therapeutic efficacy in preclinical and clinical settings. cdcs function by secreting extracellular vesicles (evs), lipid-bilayer nanoparticles laden with bioactive molecules. recently our group developed a strategy for immortalizing cdcs (imcdc) that retains their therapeutic potential and enhances cdc function indirectly through their secreted evs. imcdc show a different rna content(mirna, mrna, rrna, trna and pirna) compared to primary cdc. in particular, we focus on piwi rnas (pirnas), small rnas bound by piwi proteins, important regulators of both the epigenome and transcriptome. we seek to explore the role of a pirna highly enriched in imcdc-evs (imev-pi). methods: evs are prepared by conditioning cells for hrs in serum-free basal media, in hypoxic culture. after hrs conditioned medium is cleared of cellular debris and evs isolated using ultrafiltration by centrifugation (ufc). fractions were analysed in terms of particle size, number, and concentration and pirna content. in vitro, bone marrow derived-macrophages (bmdm) were exposed to imcdc-ev, imev-pi and control and transcriptomic profile and potentially activated pathways were assessed. in vivo, - week-old wistar-kyoto female rats received ^ imcdc-ev, imev-pi, scramble or vehicle intracoronary minutes after ischaemiareperfusion(i/r). cardiac troponin i levels, scar size and monocytes were assessed at and hrs. results: by small-rna sequencing analysis we found that pirnas are enriched in both cdc-ev and imcdc-ev. imcdc show a different pirna composition compared to primary cdc. imev-pi was identified as one of the most highly-expressed non-coding rnas (the number of reads were x higher in imcdc-ev compared to cdc-ev). in vitro, imexo-pi-conditioned bmdm exhibit a different transcriptomic profile compared with control, with upregulation of pathways involved in the inflammatory response, cell death, and cell-to cell signalling. in vivo, imev-pi is cardioprotective, as shown by reduced scar size and lower cardiac troponin levels compared to vehicleand scramble-injected animals at hrs post i/r. imev-pi only minimally alters neutrophil counts profile in blood but it alters monocytes profile with a decreased number at hrs and an increase at hrs. summary/conclusion: we posit that imev-pi is a key determinant of imcdc-ev therapeutic efficacy. our results indicate that target cells may be macrophages/ monocytes, given that imev-pi exposure modifies their composition and mrna profile both in vitro and in vivo. introduction: extracellular vesicles (exosomes, evs) are cell membrane particles ( - nm) secreted by virtually cells. during intercellular communication in the body, secreted evs play crucial roles by carrying functional biomolecules (e.g., micrornas and enzymes) into other cells to affect cellular function, including disease progression and tissue regenerations. literature previously reported that the macropinocytosis pathway contributes greatly to the efficient cellular uptake of evs. the activation of growth factor receptors, such as epidermal growth factor receptor (egfr), induces macropinocytosis. in this study, we demonstrated the effects of evs on demal papilla and hair follicle regeneration. methods: identification of distinct nanoparticles and subsets of extracellular vesicles from umbilical cord blood stem cell by asymmetric flow field-flow fractionation. results: the effects of evs from umbilical cord blood stem cell on the propagation of demal papilla and hair follicle regeneration were observed. summary/conclusion: the enhancement of extracellular vesicles from umbilicalcord blood stem cell the propagation of demal papilla and hair follicle regeneration were observed and confirmed. mechanisms of host resistance to plasma membrane damage induced by pneumolysin attack introduction: bacterial pore-forming toxins (pfts) are major virulence factors produced by pathogens. pfts target host plasma membrane (pm) and create transmembrane pores, which allow uncontrolled flux of ions and small molecules across the pm disrupting cellular homoeostasis. to survive, cells display poorly understood repair mechanisms to recover the cell homoeostasis. several mechanisms were proposed to participate in cell recovery: exocytosis of cortical lysosomes; endocytosis of pfts pores; pm blebbing and shedding. methods: we used increasing concentrations of purified ply to intoxicate cells. pm permeability was assessed by flow cytometry using propidium iodide dye. cytoskeleton rearrangements were investigated by confocal immunofluorescence microscopy. extracellular vesicles released during pm repair were isolated by high-speed centrifugation and characterized by nanoparticle tracking analysis (nta), transmission electron microscopy (tem) and mass spectrometry/ liquid chromatography analysis. results: ply triggers a complete reorganization of the actomyosin cytoskeleton inducing the formation of cortical actomyosin bundles at sites of pm remodelling. these structures assemble upon loss of pm integrity and disassemble as pm recovers. we detected the release of microvesicles during the recovery of pm integrity. vesicle population is heterogeneous with sizes ranging from to nm, with the majority of them measuring - nm. vesicle proteomic analysis revealed that they contain ply, suggesting they participate in pore removal, proteins involved in vesicle trafficking, pm repair and exosome biogenesis. summary/conclusion: our data demonstrate that cells are able to recover from the damage induced by sublytic concentrations of ply. actomyosin cytoskeleton undergo massive changes with the assembly of cortical bundles possibly at sites of pm damage. we showed that cells produced extracellular vesicles during the process of repair. we are now focusing on understanding the biogenesis of those vesicles and its importance during the process of repair. introduction: despite of high expectations, mesenchymal stromal cell (msc)-based therapies still lack efficacy, partially due to loss of cell viability and function upon administration. msc-derived extracellular vesicles (msc-ev) emulate the regenerative potential of msc, shifting the field towards cell-free therapies. clinical applications require the establishment of a scalable and gmp-compliant processes for the production and isolation of msc-ev, combined with robust characterization platforms. methods: to develop a well-established process for the production of therapeutic msc-ev, we compared different msc sources (bone marrow, adipose tissue, umbilical cord matrix), culture media compositions (dmem supplemented with foetal bovine serum (thermo fisher scientific), dmem supplemented with human platelet lysate (aventacell biomedical) and stempro msc sfm xeno free medium (thermo fisher scientific)) and culture parameters (oxygen tension and shear stress) in two different culture platforms ( d static tissue culture flask vs d dynamic spinner vessels). subsequently, msc-ev were isolated by ultracentrifugation or a commercially available isolation kit and characterized according to isev guidelines. results: msc derived from different sources/donors were able to grow under normoxia and hypoxia in d t-flasks and d spinner vessel culture systems, while maintaining their immunophenotype and differentiation potential, according to the minimal criteria defined by the isct. the time point for pre-conditioning and collection of conditioned medium for msc-ev isolation was also optimized for both d and d culture systems. msc-ev were characterized according to misev guidelines, using techniques as nta, protein and lipid quantification, western blot, imaging and fourier-transform infrared spectroscopy (ftir). the results indicate that msc-ev derived from different sources/donors have similar size distribution, however, ev yields tend to be higher for the d culture system. of notice, several spectral regions were identified by ftir, enabling the detection of differences in the biomolecules present in msc-ev, msc-conditioned media and cells produced under different conditions. summary/conclusion: in summary, this study contributes to the establishment of a scalable process for msc-ev production. evaluation of three different isolation methods for small extracellular vesicles from human plasma in prostate cancer diagnosis introduction: extracellular vesicles (evs) have great potential in prostate cancer (pca) diagnosis and progression monitoring to complement the inaccurate prostate specific antigen (psa) screening and invasiveness of tissue biopsy. however, current methods cannot isolate pure evs and therefor evs characteristics remain largely unknown. in order to develop an accurate approach for ev isolation, we aimed to compare three emerging methods with different characteristics of small evs (sevs) from human pca plasma samples and to choose the best one for diagnostic and functional studies. methods: pca patients and age-matched healthy controls (hc) plasma (n = in each group) were used to isolate sevs with different isolation methods including commercial exoquick ultra kit, qev and qev size exclusion chromatography (sec). isolated sev were characterized by nanoparticle tracking analysis, immunoblotting, cyrogenic electron microscopy, flow cytometry (fc) and proteomics analysis. for fc characterizing surface marker expression, the sevs were further purified by cd and cd commercial immunoaffinity magnetic beads . lipoprotein was captured by streptavidin biotinylated apob magnetic beads to measuring the lipoprotein contamination. results: the sev size, morphology, surface protein and protein cargo with proteomics were analysed between the three isolation methods. sevs isolated from sec methods had a lower particle size, protein amount, protein/sev marker ratio and apob+/sev marker ratio than those from exoquick ultra method. in addition, sevs isolated from qev demonstrated a significantly higher sev content, more up-regulated and down-regulated pca proteins from proteomics but lower sev marker/protein ratio and a higher protein contamination than those from qev . furthermore, sev marker signal also showed a good correlation with particle numbers instead of protein content in all the methods. summary/conclusion: qev method demonstrated better performance in isolating relatively pure sevs from human plasma; qev has the better performance in isolating samples with higher sev content; exoquick ultra isolated samples with closely sev content to the qev but with the highest non-sev protein contaminations. people can choose higher sev content or higher sev purity according to the downstream analysis. moreover, sevs may also be used for treatment monitoring, as recent studies suggested that the expression levels of certain markers may change during therapy, reflecting tumour response. for cancer diagnostics and therapeutic purposes in clinical settings, it is important to have a device which allows multiplexed measurements, in order to scan a large number of markers simultaneously and compare the expression levels of different patients, or same patients at different treatment stages, in a time efficient manner. methods: herein, we propose a multiplexed platform for label-free detection and surface protein profiling of sevs. the technique is based on the electrokinetic phenomena of streaming current and zeta potential (\zeta*) and measures the\zeta* change upon sev binding on functionalized microcapillary surfaces. for the purpose, we used sevs derived from lung cancer cells. in its current form, the platform can measure up to channels simultaneously, however, it can be further expanded. results: having demonstrated that our electrokinetic sensor successfully detects sevs in a specific way, we tested its ability to measure the expression level of membrane proteins. the analysis showed that it could detect differences in the expressions of egfr on sevs, with a sensitivity of %. we then extended the platform for multiplexed analysis, by connecting and measuring four capillaries, functionalized with different capture probes, simultaneously. for the purpose, we targeted specific tumour markers, i.e. egfr, and exosomal tetraspanin family proteins, such as cd and cd . the results showed successful multiplexed ev detection. summary/conclusion: being the sensor suitable for multiplexed sev detection, we shall present our investigation on a set of pleural effusion samples collected from a cohort of lung-cancer patients with different genetic makeup. introduction: extracellular vesicles (evs) are released to biological fluids from different tissues and organs and they contain molecules proposed as biomarkers for multiple pathological conditions. however, most ev biomarkers have not been validated due to the lack of sensitive techniques compatible with high-throughput analysis required for routine screenings. using immunocapture techniques, combining antibodies against tetraspanins and candidate tumour-specific markers we have recently optimized several assays that greatly facilitate ev characterization. methods: we have improved flow cytometry and elisa assays, increasing substantially the sensitivity for ev detection. using dls, em and analytical ultracentrifugation, we have characterised the biophysical basis of this enhancement. the final methodology can be performed in any laboratory with access to conventional flow cytometry or elisa reader. results: using combinations of antibodies specific for the tetraspanins cd , cd and cd , it is possible to detect evs in minimal volumes of urine and plasma samples without previous enrichment. additionally antibodies against other less abundant markers, like the epithelial marker epcam, have been used to capture and identify evs directly in minimal volumes of urine or plasma with sensitivity higher than western blot analysis of isolated evs. furthermore, we demonstrate that additives altering the biophysical properties of an ev suspension, increased detection of tumour antigens in these immune-assays. summary/conclusion: the development of sensitive, high-throughput methods, easily translatable to clinical settings, as elisa and flow cytometry described here, opens a new avenue for the systematic identification of any surface marker on evs, even scarce proteins, using very small volumes of minimally processed biological samples. these methods will allow the validation of ev biomarkers in routine liquid biopsy tests. introduction: when ev subpopulations are enriched on antibody microarrays and probed for their surface proteins, the detection signal is biased towards abundant subpopulations as it is dependent on both the protein expression level and the number of evs captured. to address this challenge, we developed a novel normalization approach allowing: ) the estimation of a target signal independent of ev subpopulation size through dye-based ev quantification, and ) the assessment of subpopulation target enrichment relative to the population average by leveraging tim as an unbiased, lipid-based ev capture. here, we investigated the expression of cancer-associated proteins, particularly metastasis-associated integrins (itgs), in breast cancer evs with varying metastatic potential and organotropism. methods: the relative protein enrichment profiles for various ev subpopulations were established from evs of skbr (her +), t d and mcf- (er+pr+), bt and mda-mb- (triple negative) breast cancer cell lines, as well as five mda-mb- -derived cell lines of four different organotropisms (brain, bone, lung, liver) using our custom antibody microarrays with our normalization approach. results: as expected, her was broadly detected in her + skbr evs. interestingly, her -t d and mcf- evs also expressed her where it was highly enriched in its epcam+ subpopulations. itg α , β and β were only found in triple negative and organotropic evs with itg β and β differentially enriched based on the organotropism. the population average of mda-mb- and lung-tropic evs had high expression of itg β , where subpopulations of cd + evs showed positive enrichment while cd + and cd + evs showed negative enrichment. itg α , β and β were absent in the bone-tropic cd + ev subpopulation, a profile atypical in other organotropisms. lastly, egfr was negatively enriched in tetraspanin+ subpopulations in mda-mb- evs, but positively enriched in these subpopulations in organotropic evs, especially for brain-tropism. summary/conclusion: following normalization, we were able to quantify specific protein associations, uncovering a multitude of co-enrichment profiles that characterize specific metastatic and organotropic cell lines. notably, we found enrichment signatures that distinguish between different organotropisms derived from the same parental cancer line. introduction: the tissue microenvironment surrounding tumours is complex and the cross-talk between cancer and non-cancer cells is essential for tumour growth and progression. we have previously shown that heparan sulphate proteoglycans (hspgs), on the surface of prostate cancer evs, are required for delivery of tgfβ and initiation of a disease-supporting fibroblast phenotype. however, hspgs are known to bind numerous growth factors, so here we have explored the repertoire of such proteins tethered to evs by hspgs. methods: evs were isolated from du prostate cancer cell conditioned media by ultra-centrifugation onto a sucrose cushion. vesicular hspgs were modified either by removal of heparan sulphate (hs) glycosaminoglycan (gag) chains using the enzyme heparinase iii (hepiii), or attenuation of hspg core protein expression using shrnas to knockdown specific hspgs within the parent cell. differences in proteins present in control vs modified evs were identified by a sensitive protein array, based on proximity-ligation technology, and selected targets validated by elisa. functional delivery of growth factors by ev-associated hspgs to recipient fibroblasts is being explored using a variety of in vitro techniques. results: proteome analysis identified targets that bind to hs-gag chains, and also different proteins that showed altered expression following the loss of one or more hspgs from evs. using elisa, we have been able to quantify selected candidates on wild type vesicles, some of these are lost following hsdigestion. we were also able to validate proteins on hspg-deficient vesicles. gene ontology analysis suggests that ev hspg-mediated delivery of growth factors is important for control of processes such as angiogenesis, tumour invasion and immune regulation. functional validation of proteins identified is ongoing. summary/conclusion: here we demonstrate that hspgs play a key role in loading of evs with a complex assortment of growth factors, and therefore subsequent ev-mediated growth factor delivery. we anticipate that loss or damage of ev-associated hspgs will result in attenuation of ev induction of a tumour-supporting fibroblast phenotype. introduction: ovarian cancer (oc) is the fifth leading cause of cancer-related death in women, partly due to difficulty in early diagnosis. extracellular vesicles (evs) show promise for use in early diagnostics of oc. here, evs from cervical mucus (cm) of ovarian cancer patients were used for discovery of oc biomarkers for diagnostics. machine learning was used to mine ev mirna data to develop an oc biomarker panel (validation via the cancer genome atlas). examination of the mirna targets reveal that the panel is a sufficiently accurate predictor of oc. methods: evs from the cm of patients ( highgrade serous, low-grade, benign) were isolated for small rna-sequencing. the top differentially expressed mirnas were used in a random forest and "voom" (variance modelling at the observational level) model. unsupervised approaches were used and then vetted against patient symptomology data. a tcga ovarian cancer dataset (n = ) was used for validation. results: an oc biomarker panel of micrornas (voom: . % accuracy; random forest: % accuracy) was generated. the panel consists of members from the mir- family and the mir- family, among others. the mirna targets are associated with molecular functions and pathways specific in oc progression. summary/conclusion: our method has identified ev mirna biomarkers that may be crucial for early, noninvasive detection of oc. data science has been used to develop a feedback system integrating biochemical experiments, smaller datasets, and previously available data to identify and verify a biomarker panel for oc diagnostics. introduction: liver disease has become a significant cause of morbidity and mortality among hiv patients. alcohol exposure can further exacerbate liver damage by activating hepatic stellate cells (hscs), leading to hepatic fibrosis or cirrhosis, often seen at all levels of alcohol exposure among people with hiv. due to the potentiating effects of alcohol on hiv-induced hepatocytes (hep) damage, as well as the effect of ethanol in hsc-mediated extracellular remodelling, it is imperative to understand the interplay of hep and hscs. here, we focus on the exosomes released by hiv-and ethanol exposed hep and how these exosomes modulate the functional behaviour of hscs. methods: human hepatocyte huh . cyp e [hepatoma cells stably transfected with cyp e designated as rlw cells] were infected with hiv in the presence or absence of alcohol metabolite, acetaldehyde using the acetaldehyde-generating system (ags). the conditioned medium was collected from groups of cells: untreated, hiv-, ags-and hiv+ags. quantification of exosomes number and size were evaluated with zetaview or nanosight and further characterized for exosome markers following the guideline from minimal information for studies of evs (misev ). the human hepatic stellate lx- cell line was exposed to hepatocyte-derived exosomes and assessed for the activation using pro-inflammatory markers il- β, il- , tnfα, and fibrotic markers acta , and timp using quantitative pcr. we also analysed exosome mirna content in primary human hepatocytes (phh), which potentially regulates the function of recipient cells by "programming" their inflammation/fibrosis status. the network analysis for mrna and mirna were carried out using gene ontology consortium, and mirror . and david bioinformatics resources . . results: ags treatment further enhanced the release of hiv-induced exosome from hepatocytes. size distribution assessed by zeta view or nanosight revealed that approximately - % of particles distributed in the range of to nm, with a peak at~ nm. enriched expression of hiv protein p was observed in fractions f -f . western blotting of hepatocytederived exosome demonstrated positivity for exosome-enriched proteins alix, tsg and cd specifically in f -f fractions and negative for endoplasmic reticulum protein calnexin. the uptake of hepatocytederived exosomes by hscs was apparent as demonstrated by immunofluorescence. the internalization of hepatocyte-exosome induced activation of hscs as evidenced by increased expression of pro-inflammatory il- β, il- , tnfα markers in the latter cells. summary/conclusion: we conclude that ags treatment in hiv-infected hepatocytes potentiates the release of exosomes, which, following uptake by the hscs, leads to their activation. funding: this work is supported by nih- r aa - a . antimicrobial peptide ll- induces neutrophil-derived extracellular vesicles with antibacterial potential and protects murine sepsis yumi kumagai, taisuke murakami, kyoko kuwahara and isao nagaoka juntendo university, bunkyo-ku, japan introduction: extracellular vesicles (evs) released from immune cells or other host cells upon microbial infection modulate the immune response and thereby regulate the infection. sepsis is a life-threatening multiple organ dysfunction caused by systemic dysregulated inflammatory response to infection. nevertheless, numerous therapeutic trails concerning immune dysfunction have still been disappointing outcomes. we have previously shown that ll- , a human cathelicidin antimicrobial peptide, improves the survival of caecal ligation and puncture (clp) septic mice. here, we investigated the induction of ev release by ll- and functions of ll- -induced evs in murine sepsis. methods: evs were isolated from peritoneal exudates of clp mice and the supernatant of ll- -stimulated mouse bone marrow neutrophils by differential centrifugation or size exclusion chromatography. isolated evs were analysed by flow cytometry, western blotting, and nano particle analysis. neutrophil-derived evs were injected into clp mice to assess the protective function of evs against septic mice. the antibacterial activity of evs was evaluated by incubating with escherichia coli. results: in clp mice, ll- augmented the level of evs. evs from ll- -injected clp mice contained higher amounts of neutrophil-derived antibacterial proteins (lactoferrin and cramp, cathelicidin-related antimicrobial peptide) and exhibited higher antibacterial activity compared to evs from pbs-injected clp mice. furthermore, ll- stimulated mouse bone marrow neutrophils to release evs with antibacterial potential, and administration of the ll- -induced evs reduced the bacterial load and improved the survival of clp mice. summary/conclusion: ll- induces the release of antimicrobial evs from neutrophils in clp mice, thereby reducing the bacterial load and protecting mice from lethal septic condition. identification of mirna profiles of serum exosomes in active tuberculosis introduction: tuberculosis (tb) has exceeded hiv as the most lethal infectious disease globally for two consecutive years, mainly due to difficulties in achieving early and definitive diagnosis, and timely treatment. exosomes carrying rna, particularly mirna, have demonstrated their functional and diagnostic potential in diseases including tb. however, few published studies have explored whether exosomal mirnas could be used for diagnosis of tb. thus, more systematic and comprehensive study of exosomal mirnas with regard to their potential as non-invasive tb biomarkers is still urgently needed. methods: we searched the gene expression omnibus database for datasets published before december , and performed meta-analysis on available exosomal mirna profile data for healthy control (hc) and active tb clinical specimens . reprocessing next generation sequencing data under uniform parameters and utilizing state-of-the-art bioinformatics analysis. results: we identified many distinct up-regulated and down-regulated differentially expressed exosomal mirna across multiple studies, and further screened the top , which might provide a potential panel for differentiation of hc and tb. we classified all differentially expressed mirnas into six expression patterns and identified two persistently up-regulated mirna (hsa-mir- - p, and hsa-mir- - p) as potential markers during tb progression. moreover, the differential expressed exosomal genes that we screened from the datasets were consistent with the genes overlapped with predicted mrna targets of differentially expressed mirna. pathway and function analysis further demonstrated down-regulated signalling pathways/immune response and up-regulated metabolism and apoptosis/necrosis. introduction: trypanosoma cruzi is a protozoan parasite that causes chagas disease, a relevant source of morbidity in latin america, which has spread to many countries as result of immigration of the people from endemic areas. many studies have been showed that trypomastigote forms of t. cruzi release extracellular vesicles (ev) that increase parasite infection. objectives. here, we aim to test if previous immunization with evs in adjuvant can generate a protective immune response by decreasing the effects of evs in experimental chagas disease. methods: female balb/c mice were immunized by intra peritoneal (ip) administration with × or evs isolated from trypomastigotes forms, with aluminium hydroxide adjuvant (aloh). injections were administered intravenous in doses during days ( days interval). after immunization, mice were infected intra-peritoneally with trypomastigotes forms. parasitaemia was quantified by counting motile parasites in fresh blood sample drawn from lateral tail veins. mortality and weight were analysed during the infection. in control group, the mice were immunized with aioh. results: the immunization with evs with aloh decreased the blood parasitaemia and the animals survived, while all animals died in the group aloh alone. the animals immunized with evs had an increase of f / + cd b+ and cd /cd expression in cells isolated from the peritoneum. summary/conclusion: these results indicate that t. cruzi ev antigens can induce an immune response that controls the development and establishment of the experimental chagas disease. introduction: acinetobacter baumannii (ab) is a nosocomial pathogen, of major concern due to its multidrug resistance (mdr) and the recent appearance of hyper-virulent strains in the clinical setting. the world health organization included ab as a critical priority pathogen for the development of novel antibiotics. ab pathogenesis is associated with a multitude of potential virulence factors (vf) that remain poorly characterized. there is growing evidence that outer membrane vesicles (omv) are used as vehicles to transport bacterial proteins that contribute to set up the conditions for the infections. in the present work we studied the physiopathology of mdr ab. we focused on the contribution of non-characterized outer membrane proteins (omps) associated to omvs, with special focus on lipoproteins (lp). methods: we conducted a bioinformatic prediction using available datasets to construct a list of omv-associated omps putatively acting as vf in ab . seven genes were selected and the corresponding mutants were obtained from manoil lab collection. physiological analyses of the mutants were performed, and the involvement of the selected proteins in ab pathogenesis was evaluated by adherence, invasion, and cytotoxicity assays on human lung cells a . results: biochemical analysis indicated similar growth rates in rich media, as well as similar levels of omv production for all the mutants as compared to wt. also, no differences in susceptibility to chaotropic agents were observed, indicating no alteration of the om function as a general permeability barrier. all mutants similarly reduced a cell viability, but to a lesser extent than the wt. moreover, three of them exhibited less adhesion and invasion compared to the wt, and omv isolated from these mutants displayed variable levels of cytotoxicity. summary/conclusion: these results suggest roles for the mutant gene products in ab pathogenesis and contribute to the better understanding of ab virulence mechanisms, revealing novel possible targets for therapeutic development. funding: agencia nacional de promoción científica y tecnológica (anpcyt, pict - ) medicine, nanfang hospital, southern medical university, guangzhou, , china, guangzhou, china (people's republic); d zhujiang hospital, southern medical university, guangzhou, china, guangzhou, china (people's republic) introduction: talaromyces marneffei (t. marneffei) grows as a mycelial form in the environment but multiplies rapidly as a yeast form in the host and within macrophages. the yeast can cause disseminated and progressive infections or lethal talaromycosis. but the mechanisms of pathogenicity of t. marneffei are poorly understood. fungal extracellular vesicles (evs) have previously been shown to transmit a proinflammatory message to macrophages. however, the characteristics and effects of t. marneffei evs on the progress of infection have not yet been investigated. methods: in this study, evs of t. marneffei yeasts were isolated by ultracentrifugation method. evs were detected and confirmed by electron microscopy and nanoparticle tracking analysis (nta). the raw . murine macrophages were incubated with the t. marneffei vesicles to observe the changes of macrophage morphology and function, especially in inflammatory response. the proteins, dnas, rnas of t. marneffei vesicles were respectively removed with protease, dnase and rnase. all treated evs were used to incubate with murine macrophages observe the effect on macrophages in inflammatory response. results: we observed that evs secreted by t. marneffei have a typical spherical shape with a diameter of to nm. t. marneffei evs were internalized by raw . murine macrophages and promoted the production of no and proinflammatory cytokine by macrophages in a dose-dependent manner. t. marneffei evs stimulate macrophages to generate reactive oxygen species (ros). addition of t. marneffei evs to macrophages also promoted transcription of the m -polarization marker cd and diminish that of the m markers cd . incubation of t. marneffei vesicles with murine macrophages resulted in increased levels of extracellular interleukin- β(il- β), interleukin- (il- ) and interleukin- (il- ). the proinflammatory effect of vesicles was weakened when the proteins of the vesicles were destroyed. in contrast, no similar changes were observed in degraded dna and rna. summary/conclusion: our results indicate that the extracellular vesicles of t. marneffei can stimulate macrophage towards to m polarization phenotype and promote proinflammatory function. plasma-derived extracellular vesicles as potential biomarkers in chronic chagas disease patients introduction: chagas disease (cd), caused by the parasite trypanosoma cruzi (t. cruzi), is a neglected tropical disease affecting about million people worldwide. currently, one of the main clinical problems is the lack of effective biomarkers for therapeutic response and disease prognosis during chronic infections. in that context, extracellular vesicles (evs) are raising attention as novel, minimally invasive, and inexpensive method for diagnostic and screening of diseases, as well as a new source to identify new biomarkers. the main objective of this study is to use evs derived from biological fluids of chronic cd patients for identifying novel biomarkers, specifically in the context of therapeutic response and disease prognosis. methods: plasma, saliva and urine from a cohort of chronic cd patients are being collected before and at the end of benznidazole treatment. as negative controls, healthy donors have been also included. the purification and characterization of the evs was performed by size exclusion chromatography, followed by nanoparticle tracking analysis, bead-based flow cytometry assay and transmission electron microscopy. a proteomic analysis of the evs was also performed. results: proteins associated with evs secreted by infective t. cruzi have been previously identified in cell culture, but never in human samples. our results, based on the analysis of a single heart-transplanted patient with chronic cd, showed the presence of t. cruzi and human proteins specifically associated with plasma-derived evs. noticeably, several human and parasite proteins identified in evs obtained from plasma samples, were present or upregulated before chemotherapy and were absent or downregulated following treatment. currently, proteomics analyses are being performed with higher numbers of cd plasma samples. summary/conclusion: to the best of our knowledge, this is the first proteomic profiling of plasma-derived evs from a heart-transplanted patient with chronic cd. these results thus open the possibility of using evs from biological fluids as a tool for the identification of new biomarker candidates in chronic cd. these biomarkers are essential for assessing disease introduction: eukaryotic cells communicate with one another through multiple pathways. an established route of communication between eukaryotic cells is via the production of a range of different membrane bound signalling "packages", called extracellular vesicles (evs). evs are produced by all domains of life and carry proteins, nucleic acid (rna and dna), and other biological material, travelling between cells and around the body to deliver a range of chemical messages. bacteria can also produce evs that communicate with each other to coordinate population behaviour, as well as with eukaryotic cells to stimulate host defence or induce tolerance. here i investigate the poorly explored axis where evs are the vehicle for communication between eukaryotic cells and bacteria. methods: as a first step, i have isolated evs from tissue cultured eukaryotic cells grown in advanced rpmi media with minimal ev-depleted fbs. nanoevs were isolated from spent culture media using sequential centrifugation ( , × g, , × g) and concentration ( kda filter) before purifying using size exclusion chromatography columns. nanoev-rich fractions were pooled based on particle (nanoparticle tracking analysis) and protein quantity data. nanoevs were characterised by electron microscopy and expression of exosomal markers. eukaryotic nanoevs were then characterised in their effect upon the growth of escherichia coli as a model bacterium, also grown in tissue culture media to mimic relevant in vivo conditions. results: further experiments with increased dosages are required to determine the effect of human evs on bacteria. summary/conclusion: our work will investigate whether human evs communicate with the resident and pathogenic microbiota, while examining the mechanisms behind this communication. escherichia coli pathogenic bacteria commensal bacteria hydrogen sulphide (h s) derived extracellular vesicles: a potential protective role in response to respiratory syncytial virus (rsv) infection methods: evs were isolated from untreated (control evs) and gyy treated (gyy-evs) a cells, a human alveolar type ii-like epithelial cell line. evs were purified using a two-step enrichment procedure. evs were characterized using particle sizing (size and concentration) and western blot for the ev markers. electron microscopy and immunofluorescence staining were used to investigate presence of multivesicular bodies (mvbs), evs precursors, in both groups. recipient a cells were cultured for hours in the presence or absence of control-or gyy-evs, then infected with rsv for hours. viral titres by plaque assay were measured in recipient infected a cells. results: we confirmed the presence and purity of our evs. we found that gyy reduced the particles number of evs, but did not change ev size. a cells treated with gyy showed an accumulation of mvbs/lysosomes-like structures, as well as an increase in cd expression, a mvbs marker, compared to untreated cells. recipient a cells treated with gyy-evs showed lower viral replication than control ev-treated cells in response to rsv infection. we are currently investigating the potential mechanism for this observation and characterizing the rna cargo composition of gyy-evs. summary/conclusion: no vaccine or effective treatment is currently available for rsv. cellular pretreatment with gyy-evs reduced the rsv replication in airway epithelial recipient cells, suggesting that h s could exert its antiviral activity in the context of rsv infection potentially through modulation of ev composition. therefore, gyy-evs could represent a future novel pharmacological approach for ameliorating virus-induced lung disease. effects of extracellular vesicle-mediated transmission on reoviridae infection results: taken together, these data suggest that multiple particles of reovirus and rotavirus egress in large, virus-modulated evs, and that transmission in evs increases segment complementation compared to transmission as free particles. summary/conclusion: these discoveries may be broadly applicable to viruses that travel in evs and will contribute to general principles of virus transmission and diversification. continued studies will illuminate the specific cellular pathways reovirus and rotavirus utilize for successful egress. these pathways may prove to be critical targets for the improvement of vaccines and oncolytic therapy. multiparameter flow cytometry analysis of the human spleen and its interaction with plasma-derived evs from plasmodium vivax patients introduction: the spleen is a secondary lymph organ that filters blood and elicits immune responses against blood-borne pathogens, such as malaria parasites. extracellular vesicles (evs) are membrane-bound particles involved in intercellular communication. evs play several roles in malaria ranging from modulation of immune responses to induction of vascular alterations. here, we report the first integrated characterization of human spleen cells using multiparameter flow cytometry (mfc) describing subpopulations of splenic leukocytes and red blood cells (rbcs), and studied their interaction with plasma-derived evs from p. vivax patients (pvevs). methods: human spleens were obtained from organ transplantation donors. myeloid, lymphoid, erythroid and haematopoietic stem cells (hscs) were immunophenotyped by mfc. t cells, dendritic cells (dcs) and rbcs were enriched by density centrifugation and immunomagnetic isolation. pvevs and healthy donors evs (hevs) were purified by size-exclusion chromatography (sec) and characterized by bead-based flow cytometry. enriched evs were labelled with fluorescent lipophilic dyes and incubated with total splenocytes or enriched populations. evs-cells interaction was assessed by flow cytometry. results: human spleen immunophenotyping showed that cd + cells included b ( %), cd + t ( %), cd + t ( %), nk ( %) and nkt ( %) lymphocytes. myeloid cells comprised neutrophils ( %), monocytes ( %) and dcs ( . %). erythrocytes represented % whereas, unexpectedly, reticulocytes were . % of total cells. in addition, we also detected hscs, which accounted for . %. sec separated evs from the bulk of soluble plasma proteins as shown by the enrichment of cd , cd l and cd markers. interaction studies showed an increased proportion of t cells (cd + -fold and cd + -fold), monocytes ( . -fold) , b cells ( . -fold) and erythrocytes (threefold) interacting with pvevs as compared to hevs. summary/conclusion: the integrated cellular analysis of the human spleen and the methodology employed here allowed in vitro interaction studies of human spleen cells and evs. a larger proportion of monocytes, t and b lymphocytes as well as erythrocytes was found to interact with pvevs compared to hevs. future functional studies of these interactions can unveil pathophysiological processes involving the spleen in vivax malaria. neuroblastoma-secreted exosomes carrying mir- promote osteogenic differentiation of bone marrow mesenchymal stromal cells introduction: bone marrow (bm) is the major target organ for neuroblastoma (nb) metastasis and its involvement is associated with poor outcome. yet, the mechanism by which nb cells invade bm is largely unknown. tumour microenvironment represents a key element in tumour progression and mesenchymal stromal cells (mscs) have been recognized as a fundamental part of the associated tumour stroma. here, we explore the potential role of nb-derived exosomes in induction of a pro-osteogenic phenotype on bm-mscs. introduction: extracellular vesicles (evs) are nanosized particles delimited by a lipid bilayer which transfer functional molecular cargos from the cells of origin to target cells. this intercellular crosstalk controls both physiological and pathological conditions. given their presence in body fluids and their characteristics, these nanocarriers might be potentially used in diagnostics and/or therapy. breast cancer is the most frequently diagnosed malignancy and ranks as the leading cause of cancer mortality in women worldwide; the triple negative breast cancer, in particular, is the most aggressive subtype with a poor prognosis. since it is recognized that cell stiffness of cancer cells play a crucial role during the metastatic spreading, we set ourselves the goal of clarify the effects and the activity of small-evs (i.e. with a diameter below nm) in metastatic breast cancer, with a special attention on their correlation with the biomechanical properties of cells. methods: functional assays were performed on the non-invasive mcf breast cancer cell line, before and after the cellular uptake of small-evs originating from the invasive mda-mb- triple negative breast cancer cell line. the mechanical properties (cell stiffness, cytoskeleton organization and focal adhesions) of mcf cells were investigated before and after the vesicle uptake. results: the uptake of small-evs derived from mda-mb- significantly reduces the young's modulus values of mcf cell line making them more invasive. moreover actin and focal adhesion variations were observed in mcf cells before and after small-ev's uptake, suggesting a molecular rearrangement inside mcf cells upon uptake. summary/conclusion: our results evidence that small-evs play a key role in altering biomechanical properties of target cells and underline their relevance in cell-cell crosstalk. our approach is very promising to identify new molecular mechanisms through which evs perform their oncogenic function. stratification of angiogenic or non-angiogenic lesions in colorectal cancer liver metastases patients using extracellular vesicle mirna introduction: colorectal carcinoma (crc) is the second leading cause of cancer death in the western world. over % of the crc patients develop liver metastasis (lm) and % will die from metastatic disease. in the current clinical setting, liver resection provides the only possible cure, but only % of crclm patients are resectable. the combination of angiogenic inhibitors with chemotherapy is used to downsize crclm with the goal of converting unresectable patients to resectable ones. however, only - % of these patients can be successfully converted to a resectable state. we have no way of identifying those crclm patients that would respond/benefit to the addition of anti-angiogenic therapies (e.g. bevacizumab: bev)). proper stratification of patients into angiogenic inhibitor responders and non-responders will permit a proper assessment of the efficacy of angiogenic inhibitors. crclm forms distinct histopathological growth patterns (hgp): angiogenic (desmoplastic) and nonangiogenic (replacement) hgp. we demonstrated that crclm patients with predominant angiogenic lesions receiving bev plus chemotherapy have a more than double -year overall survival compared to patients with non-angiogenic lesions. therefore, nonangiogenic lesions do not respond to angiogenic inhibitors. our study focuses on stratifying angiogenic vs non-angiogenic lesions of crclm through extracellular vesicle mirnas. we are using two approaches in the selection of mirnas to target: . text mining of published ev mirna from crclm patients; and . differentially expressed mirnas present in tumour tissue from both lesion types, we have obtained by sequencing - patients. these two strategies will generate a list of mirnas that we will target using qpcr on plasma-derived ev mirna from the patients used in approach , where we have classified the lesions in the patients. preliminary data on patients will be presented. methods: ev isolation was performed using the gold standard centrifugation method. rnaseq and qpcr are used to generate the expression profile for angiogenic vs non-angiogenic type of crclm. results: the research is under progress. summary/conclusion: the research is under progress. the introduction: it is known that bone metastasis causes a reduction in the quality of life of cancer patients due to fractures and nerve compression. therefore, it is important to elucidate the mechanism of bone metastasis and develop new treatments. metastatic bone tumours occur at particularly high rates in cancers of the prostate, breast, and lung. in this study, we focused on extracellular vesicles (evs) in bone metastasis, and investigated that the role of evs derived from cancer cells in osteolysis. methods: the prostate, breast, and lung cancer cellderived evs were added to osteoclast precursors with rankls. the osteoclast differentiation was evaluated by tartrate-resistant acid phosphatase (trap) stain and by measuring the expression level of osteoclast markers using by qrt-pcr. a proteome analysis (lc-ms/ms) and sirna approaches were used to identify molecules which are responsible for promotion of osteoclast differentiation in the prostate cancer cellderived evs. to investigate whether the molecules are suitable for the detection of bone metastasis in serum evs, we isolated evs from serum of prostate cancer patients, and analysed the protein level of the molecules by western blot analysis. results: we found that the prostate cancer and lung cancer-derived evs significantly promoted the rankl-stimulated osteoclast differentiation. our analysis revealed that cub domain-containing protein (cdcp ), which is a membrane protein on the prostate cancer cell-derived evs, was responsible for promotion of osteoclast differentiation. moreover, cdcp was markedly detected in the evs-derived from serum of prostate cancer patients who had bone metastasis than that of normal subjects. we also found that cdcp exits on the breast and lung cancer cell-derived evs. summary/conclusion: we showed that the evsderived from bone metastatic tumours have a role in activation of osteoclastogenesis. moreover, we revealed that cdcp in the evs is responsible for promoting of osteoclast differentiation. these evs could be the novel diagnostic and therapeutic target for bone metastasis. increased expression of chemokine receptor cxcr in non-invasive colorectal cancer cells after incorporation of platelet-derived extracellular vesicles. introduction: blood platelets and platelet-derived extracellular vesicles (p-evs) play a crucial role in tumour growth and metastasis. p-evs, also referred to as platelet microparticles, are recognized as a carrier for proteins and nucleic acids that control cell-to-cell communication, mediate the formation of metastatic niches and affect tumour invasion and metastasis. among the other factors, p-evs contain the chemokine receptor cxcr , known as a co-receptor for hiv entry but also regarded as important in cancer development due to the importance of cxcr /cxcl signalling. overexpression of cxcr was reported in various, especially in invasive cancers, including colorectal cancer (crc). crc, the third most commonly diagnosed cancer, is usually diagnosed at the late stage and patient's death is mainly related to metastasis. increased levels of cxcr has been reported as a poor prognostic factor for survival of crc patients and its blocking has been suggested as therapeutic approach. the aim of this study was to analyse the effect of p-evs on the levels of cxcr in crc cells on various epithelial-to-mesenchymal transition stage. methods: we used crc cell lines ht and sw , which represent distant invasive potential and different phenotypes, epithelial and strongly mesenchymal, respectively. p-evs were isolated from outdated concentrates of human blood platelets after activation by thrombin in the presence of calcium ions, by subsequent centrifugation and ultracentrifugation. the p-evs were labelled using pkh fluorescent dye to visualize their uptake into cell lines by confocal microscopy. we also quantified the levels of cxcr in ht and sw by western blot analysis. the effect of p-evs uptake on the migration of crc cells was studied by "wound healing" method. results: we found that the levels of cxcr in crc lines used in the study were correlated with their emt stage. we show here that p-evs released by activated platelets were incorporated into both ht and sw cell lines. the expression of cxcr in ht was increased after the uptake of p-evs. additionally we observed that migration rate of ht cells with incorporated p-evs was elevated as compared to control cells. summary/conclusion: we posit that circulating p-evs can be incorporated into yet not invasive crc cells to significantly increase the level of cxcr receptors and that may lead to the their more invasive characteristics. introduction: for cancer therapy it is important to identify markers and key processes induced during cancer progression. one of them is epithelialmesenchymal transition (emt) which is associated with cell acquisition of invasiveness, stem cell characteristics and resistance to apoptosis and therapy. also the extracellular vesicles (evs) released from tumour cells, which can be taken up by cells constituting pre-metastatic niches, can alter cancer progression by promoting cells' reprogramming. our group has recently reported that snail transcription factor, a key factor of emt, when overexpressed in crc ht cells, drives their early emt and alters the expression of microrna (mirs). in the present study we analysed the mirs profile of evs released from those cells. methods: evs from three ht clones stably overexpressing snail and from control ht -pcdna were isolated by differential centrifugation and ultracentrifugation of conditioned media after h of culturing in serum-free medium. total rna was isolated and nextgeneration sequencing (ngs) analysis of the mirnas was performed followed by gene ontology ( introduction: prostate cancer (pca) is the most common malignant tumour in male urinary system and osteoblastic bone metastasis is the most observed metastasis in prostate cancer patients. it has been demonstrated that circulating micrornas contained in extracellular vesicles are potential early biomarkers and therapy targets for many diseases. however, the potential role of micrornas in prostate cancer bone metastasis, is not yet to be fully explored. methods: after isolation and purification evs using ultracentrifugation from conditioned media of bone metastatic co-opting prostate cancer cells and normal cells, total rna was extracted. subsequent to library preparation and small rna-seq, differential gene expression analysis was performed. data were filtered by mean mirna expression of ≥ reads, two fold up or down regulation between . − . and adjusted pvalue ≤ . . the uptake of pca-sevs was performed. three candidate mirnas (has-mir- c- p; has-mir- ; has-mir- - p) were internalized and osteoblast differentiation were detected by qpcr, histochemical staining and protein activity detection. results: total reads of mirnas in bone metastatic co-opting pca-evs exceeded significantly than that in normal evs (p < . ), indicating that mirnas delivered by pca cells play critical role in pca bone metastasis. pca-cm enhanced osteoblast differentiation and can be reversed by gw . the uptake of pca-evs by mc t -e was efficient. the high expression of the three candidate mirnas in pca-evs was verified by qpcr. all the three candidate mirnas promoted osteogenesis, verified by mrna expression of osteoblastic markers (alp, ocn, runx , osx), alp activity, alp staining and aliza red s staining. summary/conclusion: these findings suggest that mirna cargos in pca-evs play a pivotal role in the development of osteoblastic bone metastasis of pca, which can be potential early biomarkers and therapy targets for prostate cancer bone metastasis. funding: this work was supported by grants from the national natural science foundation of china ( ); xijing hospital science and technology foundation project (xjzt ptk ). introduction: retinoblastoma (rb) is the most common intraocular cancer of childhood. despite recent advances in conservative treatment have greatly improved the visual outcome, local tumour control remain difficult in presence of massive vitreous seeding. thus, the identification of new biomarkers is crucial to design more effective therapeutic approaches. traditional biopsy has long been considered unsafe in rb, due to the risk of extraocular spread. exosomes, nano-sized vesicles containing nucleic acids and proteins, represent an interesting alternative to detect tumour-associated biomarkers. the aim of this study was to determine the protein signature of exosomes derived from rb tumours (rbt) and vitreous seeding (rbvs) primary cell lines. methods: exosomes from rbt (hsjd-rbt , hsjd-rbt , hsjd-rbt , hsjd-rbt ) and rbvs (hsjd-rbvs , hsjd-rbvs , hsjd-rbvs ) cell lines were isolated by high speed ultracentrifugation. vesicles number and size were confirmed by nanosight and scanning electron microscopy. protein content was analysed by bicinchonic-acid assay and high resolution mass spectrometry. results: a total of proteins were identified. among these, and were expressed in exosomes rbt and one rbvs group respectively. gene enrichment analysis of exclusively and differentially expressed proteins and network analysis identified identified in rbvs exosomes upregulated proteins specifically related to invasion and metastasis such as proteins involved in extracellular matrix (ecm) remodelling and interaction, resistance to anoikis and metabolism/catabolism of glucose and aminoacids. summary/conclusion: in conclusion, in this study, we isolated exosomes from rb primary tumour and vitreous seeding cell lines and characterized their content with a proteomic approach. this is the first evidence describing a proteomic exosome signature specifically associated with vitreous seeding in rb. this characterization may represent a starting point for future analyses that allow defining exosomal markers as promising diagnostic and potential prognostic markers in rb as well as therapeutic targets. activation of hepatic stellate cells by extracellular vesicles released by uveal melanoma cells introduction: uveal melanoma (um) is the main intraocular tumour in adults, and is particularly resistant to treatments when disseminated to the liver. our hypothesis is that extracellular vesicles (evs) released by the primary tumour are priming the liver stroma for metastatic cell colonization by activating hepatic stellate cells (hstecs). this study aimed to characterize evs from um cells, and to determine their interactions with liver cells. methods: evs were isolated from cell lines derived from ocular tumours and liver metastases by differential centrifugation. their concentration/diameter range were determined by high-sensitivity flow cytometry. cryo-tem combined with receptor-specific gold labelling was used to reveal the morphology/size of melanomic evs. the presence of melanoma and ev markers was assessed by western blotting. the internalization of fluorescent melanomic evs in hstecs and their subsequent activation were assessed by confocal imaging using alpha-smooth muscle actin (alpha-sma) and phalloidin stainings. ev impact on invasion was measured with a tumour spheroid model embedded in extracellular matrix. melanomic evs were inoculated into the retro-orbital sinus of immunodeficient mice to study their selective organ distribution. results: melanomic evs were positive for annexin- , tetraspanins, as well as some melanoma markers. stellate cells with internalized melanomic evs expressed more alpha-sma, reflecting their activation. adding evs on tumour spheroids increased the invasion process. melanomic evs were localized into different murine organs, but mainly into the liver, as observed by in vivo fluorescent imaging. introduction: exosomes are being tested for their use as therapeutic agents in degenerative and chronic diseases. however, the optimal source of exosomes is currently under investigation. amniotic fluid (af) is a naturally-rich source of exosomes that is easily obtained for use in regenerative medicine. organicell flow™ is a minimally-manipulated, acellular product derived from human af and consist of over cytokines/chemokines as well as exosomes derived from the amniotic membrane and surrounding tissues. we characterized the exosome fraction of our product to elucidate the protein cargo of af exosomes and demonstrate the therapeutic potential as a novel regenerative therapy. methods: the exosome fraction of our product was analysed using nanosight nanoparticle imaging and macsplex exosome surface marker array analysis. exosomes were precipitated using size-exclusion filtration followed by ultracentrifugation from independent products (in triplicate) and subjected to protein lysis and preparation for mass spectrometry analysis using the easy nlc and q exactive instruments. tune (version . ) and xcalibur (version . ) was used to collect data while proteome discoverer (version . ) was used to analyse data. protein expression lists were created by merging the sample replicates together and commonly expressed proteins were determined using vinny . vin diagram analysis. webgestalt tool kit classification system was used to identify top protein function and pathway hits. results: organicell flow™ contain a mean concentration of . x ^ particles/ml (n = ) with a mean mode size of . nm (n = ). surface marker analysis confirms the presence of exosome associated proteins cd , cd , and cd in addition to a high expression of cd (n = ). the completed analysis revealed commonly detected proteins across products. the top molecular functions of identified proteins included protein-binding, ion-binding, and nucleic acid-binding with enzymes, transcription regulators, and transporter proteins representing the most abundant protein groups. pathway enrichment analysis revealed top hits for integrin, pdgf, and p pathways. a deeper dive into the enzyme category of the protein cargo further demonstrates the presence of proteins that promote dna repair such as dna polymerase (beta and lambda), telomerase reverse transcriptase, and brca . summary/conclusion: organicell flow™ characterization demonstrates the therapeutic potential of afderived exosomes. proteomic analysis revealed protein cargo that may regulate various growth factor and cellcycle associated pathways. furthermore, the presence of dna damage response proteins suggests a possible mechanism for induction of cellular repair. generation of car-t and γδt cell-derived exosomes for future cell free immunotherapies γδt cells are a subset of t cells with dual innate and adaptive qualities. this duality provides various advantages over their more studied and used counterpart, αβt cells. in the present study, we sought to compare the immunotherapeutic potential of car-t cell and γδt cell-derived exosomes as novel cell-free based alternatives. methods: cd -targeting car-t cells were obtained following the isolation, expansion and transduction of αβt cells using a lentiviral vector bearing the car construct. γδt cells were isolated and expanded from peripheral blood mononuclear cells (pbmcs) following innate or adaptive stimulation. exosomes from both cell sources were isolated after a -day culture in serum-free media using ultracentrifugation-based methods. exosomes were characterized by nanoparticle tracking analysis (determination of size) and western blot assays (detection of the appropriate surface markers). nalm- (b cell precursor leukaemia) cells were used as target cells for assessment of exosome cytotoxic/ killing function. car-t cell and γδt cell-derived exosomes were incubated at particles/target cell for -hours. total viable cell counts were assessed via imaging-based cytometry (nc- ) utilizing acridine orange and dapi staining. results: exosomes derived from γδt cells activated via innate mechanisms showed significant killing of nalm- as compared to exosomes from non-activated or adaptively activated γδt cells. in comparison, car-t cell-derived exosomes showed minor killing capabilities of the target cells. summary/conclusion: here, we report for the first time that exosomes derived from cd car-t cells and innately activated-γδt cells show/exert inhibitory action on nalm- cells. further studies are currently underway to identify the underlying mechanism(s) responsible. introduction: age-related cognitive dysfunction is associated with increased oxidative stress, low-level chronic neuroinflammation, and waned hippocampal neurogenesis in the brain. from this perspective, biologics capable of modulating oxidative stress and neuroinflammation, and stimulating neural stem cell activity in the brain might be useful as anti-ageing interventions. methods: we investigated the efficacy of intranasal administration of extracellular vesicles (evs) generated from cultures of rat subventricular zone neural stem cells (svz-nscs) in the middle-aged mice to alleviate cognitive and mood dysfunction, increased oxidative stress, neuroinflammation, and neurogenesis decline in old age. mice were treated intranasally with nsc-evs once weekly for three weeks ( billion per administration) starting from . months of age. a month later, the animals were examined for cognitive, memory, and mood function using multiple behavioural tests, and brain tissues were examined for oxidative stress, neuroinflammation, and neurogenesis. results: object-based tests revealed that aged animals receiving vehicle displayed cognitive impairments for discerning minor changes in the environment as well as for distinguishing similar but not identical experiences. these animals also exhibited spatial memory dysfunction and anhedonia. in contrast, aged animals receiving nsc-evs showed improved cognitive and mood function. biochemical analyses of brain tissues revealed that nsc-ev treatment normalized elevated concentrations of oxidative stress markers malondialdehyde and protein carbonyls and the proinflammatory cytokine interleukin- beta. moreover, nsc-ev treatment stimulated increased production of antiinflammatory protein interleukin- and the antioxidant superoxide dismutase. immunohistochemical analysis revealed modulation of neuroinflammation typified by reduced activity of reactive astrocytes and activated microglia and improved hippocampal neurogenesis. summary/conclusion: the results suggest that the intranasal administration of nsc-evs is a promising approach for maintaining better cognitive and mood function in ageing through modulation of oxidative stress, neuroinflammation, and neurogenesis. funding: supported by a grant from the national institute of neurological disorders and stroke ( r ns - to a.k.s.) chemically modified myocytes-derived evs for the treatment of cardiac fibrosis. marta prieto-vila a , asao muranaka a and takahiro ochiya b a tokyo medical university, tokyo, japan; b tokyo medical university, shinjuku-ku, japan introduction: myocardial fibrosis is a disorder that may occur after cardiac injure due to a malfunction of the cardiac remodelling. fibroblasts resident in myocardium are erroneously activated causing an excessive accumulation of extracellular matrix, which decreases cardiac function and eventually, leads to death. it is known that cardiomyocytes communicate with the surrounding cells such as fibroblast and endothelial cells by extracellular vesicles (evs). the loss of this communication is thought to play a central role in cardiac fibrosis. therefore, cardiomyocytes-derived evs may be a promising a cell-free system for the treatment of fibrosis inhibition. methods: a novel culture medium was stablished to improve the expansion of primary cardiac myocytes. this was tested using two commercially available primary myocytes cell lines. evs were collected by serial ultracentrifuges, and their effect on fibrosis was tested. for that, prior to any treatment, and to mimic fibrosis, primary cardiac fibroblast were activated overnight with tgfβ. results: by the use of a defined conjunct of chemicals, mature cardiomyocytes culture was highly improved to ensure a high collection of evs. terminal differentiation markers, as well as senesce apparition was delayed in comparison to predetermined culture medium. interestingly, those primary cells secreted a rather large amount of evs, which expressed common evs membrane marker. tgfβ-treated cardiac fibroblasts were co-cultured with myocytes showing a decrease of fibroblast activation markers both at mrna and protein levels. similar results were found when activated fibroblast were treated with evs. summary/conclusion: our findings indicate that the use of evs derived from chemically modified myocytes is a promising treatment for ischaemic myocardial fibrosis. however, further molecular experiments have to be done to identify the molecules within evs responsible for the inactivation of fibroblast. evaluation of osteoinductive and anti-inflammatory properties of spinederived exosomes renaud sicard a , tania del rivero b , jonathan messer c , shabnam namin c and timothy ganey c a vivex, biologics, inc., miami, usa; b vivex, biologics, inc., miami, usa; c vivex, biologics, inc., miami, usa introduction: over the last decades, mesenchymal stem cell-derived exosomes have been shown to play a crucial role in a myriad of cell function such as extracellular matrix synthesis, proliferation, differentiation or cell migration. biological sources of exosome (heterogeneous or homogeneous cell population, serum, urine etc.) have a direct influence on the content of their cargo and their therapeutic application and potential. in this study, we evaluated exosomes excreted from cadaveric spine-derived cells. we hypothesized that exosomes derived from a bone source such as the spine, will drive the osteogenic differentiation of progenitor cells. we also investigated their effects on inflammation in nucleus pulposus cells using an in-vitro assay. methods: after their isolation and characterization, exosomes derived from cadaveric human spines were assayed for osteoinductive properties. a c c myoblast cell line was treated with different concentrations of exosomes and expression of alkaline phosphatase was measured after days incubation. treatment with bmp- was used as positive control. anti-inflammatory properties were assessed by incubating tnf-treated nucleus pulposus cells with exosomes for days. qpcr analysis of mrna expression of inflammatory cytokines (il- , il -beta, il- ) metalloproteinases (mmp and adamts ), and apoptotic genes (bax, bcl ) was used to determine the effects of exosomes on inflammation. results: spine-derived exosomes positively expressed the exosome flow cytometry markers tested (cd , cd and cd ). the mean number of exosomes per microgram of protein was . ± . x indicating a relatively high purity. osteoinductive (oi) testing was performed using different concentrations of exosomes. the oi index of treatment of c c cells with bmp- , x , x , x , × or × exosomes alone was . , . , . , . , . and . respectively. anti-inflammatory properties of exosome are currently being assessed and will be presented at the time of the poster presentation. summary/conclusion: administering exosomes alone or in combination with an exogenous scaffold has the potential to repair injured tissue and to restore bone function. the clinical significance of this application is aimed to promote the patients' bone healing process and provide a cell-free therapeutic platform that is safe and effective. administration of human mesenchymal stem cell derived extracellular vesicles modulates the abnormal plasticity of newly born neurons and neuroinflammation in a rat model of status epilepticus maheedhar kodali a , daniel gitai b , dong ki kim a , mariam atobiloye a , bing shuai c , sahithi attaluri c , raghavendra upadhya c , leelavathi n madhu a , olagide w. castro a , darwin j. prockop a and ashok k. shetty c decline in the percentage of newly born neurons displaying basal dendrites. besides, ev treated animals displayed higher percentages of resting microglia (ramified microglia), reduced percentages of activated microglia (microglia expressing iba- and cd ), in comparison to animals receiving vehicle after se. interestingly, diminished abnormal plasticity of newly born neurons was accompanied by the preservation of interneurons positive for reelin; a protein believed to guide newly born neurons to their correct locations. summary/conclusion: the results suggest that even a low dose in administration of msc-derived evs after se can limit neurons loss, dampen the abnormal plasticity of newly born neurons, and modulate the activation of microglia. introduction: autism spectrum disorders (asd) are neurodevelopmental disorders characterized by three core symptoms that include social interaction deficits, cognitive inflexibility, and communication disorders. they have been steadily increasing in children over the past several years, with no effective treatment. two percent of all asd patients are suffering from a disorder caused by a mutation in the shank gene. shank is an important synaptic protein, disruption of this gene directly leads to cognitive and motor impairments. during the recent decade, exosomes that derived from mesenchymal stem cells (msc-exo) have been spotlighted as a promising therapeutic target for various clinical indications, including neurological disorders. here we test three different autistic mice models. btbr as a multifactorial mice model of autism and two different shank mutated mice. the first is a complete deletion of exon ( q . ) and the second is a specific insertion mutation of guanine to position in the gene (insg ) that leads to stop codon. methods: exosomes were isolated using differential centrifugation protocol and characterized using the misev guideline recommendations. each animal received an intranasal administration of ul containing exosomes/µl. for intravenous administration, the same number of exosomes, were used, injected in µl. results: all three animal models showed significant improvement in their autistic behavioural phenotypes following intranasal administration. the improvement seems to be dose-dependent and was better achieved via intranasal vs intravenous administration. biodistribution of msc-exo showed accumulation in the brain within hours, yet the reduction of the signal was observed in the kidneys, heart and lungs. summary/conclusion: our data suggest that exosomes derived from adipose msc, carry a therapeutic potential in asd, via non-invasive intranasal administration in three different mice models. these data further emphasize our potential therapeutic strategy to reduce symptoms of autism in clinical trials. funding: stem cell medicine ltd. israel. equine tendon injury treatment by evs: an in vitro study introduction: current treatment options for tendinopathies (chronic, painful tendon disorders), are not able to restore the functional properties of native tendons. hence, new treatment options are sought. the efficacy of mesenchymal stem cells (mscs) therapies, which combined with a rehabilitation programme including controlled exercise is the current gold standard in equine tendon treatment, has been shown to be largely due to the cells´paracrine activity. the aim of this study was therefore to evaluate the effect of bone marrow msc derived autologous and allogeneic conditioned medium (cm, full secretome) and their extracellular vesicles (evs) on "tendon healing" in vitro. methods: to compare the "therapeutic" effect of msc derived evs and cm, a standardized scratch assay (wound healing assay) was performed. cm from equine tenocytes, ev depleted medium and medium with or without fcs served as controls. tendons and bone marrow aspirates were obtained from three horses ( , and years) which were euthanized for reasons unrelated to this study. mscs were isolated by ficoll density gradient centrifugation and tenocytes were obtained by migration from tendon explants. for cm and ev production, cells were cultured in ev depleted medium. evs were harvested by a stepwise ultracentrifugation approach and characterized by nanoparticle tracking analysis (nta), western blot (cd , cd ) and transmission-electron microscopy (tem). results: western blot, nta and tem confirmed successful isolation of evs from equine mscs. the strongest positive effect on wound healing (fastest gap closure) was achieved by msc-cm (p < . ). the gap closure achieved with msc-evs was slower than with msc-cm (p < . ) but faster than with cm of tenocytes (p < . ). donor specific differences in wound healing capability were shown for both autologous and allogeneic application. summary/conclusion: treatment with msc-cm resulted in significantly faster wound healing of adult tenocytes in vitro than msc-evs or tenocyte-cm. mscs donor age shows a significant effect on gap closure following autologous but not allogeneic administration. ev-enriched secretome fraction from gmp-compatible, scalable, human ipsc-derived cardiac progenitors improve heart function in chronic heart failure mice introduction: we have shown that research-use-only grade (res) human ipsc-derived cardiac progenitors (cpcres) can produce a secretome whose small-evenriched fraction (svf) can treat chronic heart failure (chf) in mice. gmp-compatible, scalable processes for a cpc-derived svf suitable for human therapeutic use is needed. methods: ipsc-derived cpc were produced and cultured using gmp-compatible, scalable processes (cpctx). media without cells were "cultured" in parallel for "virgin media" controls (mv). cpcres were cultured as previously described. as a proof of concept, svfs were isolated from conditioned media by ultracentrifugation: cpctx-ev, cpcres-ev and mv. particle size distributions/concentrations (nanoparticle tracking analysis), protein levels (bsa), and the presence of cd- (elisa) were determined. in vitro activity was assessed by huvec scratch wound healing assay, and by rat and human cardiomyocyte (cm) survival assays. c bl/ mice in chf received echoguided myocardial injection of pbs vehicle control ( ul, n = ), cpctx-ev ( ul, n = ), or cpcres-ev ( ul, n = ). change in cardiac function was assessed by echocardiography. results: cpctx-ev particle sizes were polydisperse (mode~ nm) at a concentration of~ . e particles/ml (~ , particles/cell) and~ . mu cd /ug protein. cpctx-ev increased wound healing, human cm survival, and rat cm survival in vitro by . x, . x, and x, respectively over mv controls. in chf mice, significantly less cpctx-ev mice, and less cpcres-ev mice had severely progressive heart failure (left ventricular end systolic volume, lvesv, increased > %) than pbs control mice (pbs vs cpctx-ev, p < . ; pbs vs cpcres-ev, p < . ), and the average ejection fraction of the pbs group deteriorated . x more than the cpctx-ev group (− % vs − . %, respectively; ns). summary/conclusion: we have a process for cpc differentiation and production of conditioned media suitable for use in human clinical trials from which can be made an svf with the potential to treat chf, possibly through re-vascularization or preservation of cm viability. introduction: exosomes are nanoscale vesicles that mediate cell-to-cell communication via exchanging molecular cargo. mesenchymal stem cell (mscs) modification towards an osteogenic path can occur by uptake of exosomes from other cells. it is less clear whether vesicle placement in the absence of cells will facilitate site-specific delivery through acellular transfer of osteogenic activity. an electrospun fleece was combined with bone marrow-derived exosomes in the absence of cells to evaluate osteoinductive potential that might be thermo-stable and be used in a biologically neutral collagen carrier. comparisons were made of standard laboratory assay of osteoinductivity (oi), and in vivo expression in a mouse calvarial defect model. methods: electrospun type-i collagen was prepared with and without hydroxyapatite (ha) (spinplant gmbh, leipzig) as a foundation base for application of the bone marrow-derived exosomes. individual discs of the collagen enhanced scaffolds ( -mm) were prepared and placed in a mouse calvarial skull defect. animals were followed for and weeks. exosomes were isolated from qualified cadaveric human spines by differential ultracentrifugation. microscopic observation, quantitative assessment of oi with an alkaline phosphatase assay, and flow cytometry were used to evaluate the composition, the hybrid nature of the addition to the nano-collagen fibres. a fluorescent protein reporter transgenic mouse model expressing osteocalcin, type-i collagen, phex, and sp (osterix) was evaluated at and weeks to determine bone formation across the defect. results: alp activity on the scaffold with ha demonstrated an approximate tenfold increase to that of the collagen scaffold alone. while a dose-dependent effect, with higher doses of exosomes resulting in a greater amount of alkaline phosphatase expression, expression that exceeded that of the ng bmp- control. dose escalation from . , , and e resulted in similar increases in expression that was statistically greater with the combination of the fleece with the exosome component. bone formation in the mouse calvaium did not demonstrate gap closure at or at weeks, but did demonstrate enhanced osteoclastivity and robust bone remodelling at the margins of the defect. summary/conclusion: bone marrow-derived exosomes dried into an electrospun fibrillar collagen demonstrated in vitro osteoinductive potential that might provide site-specific placement that could enhance biologic potential. with the capacity for ambient temperature storage, the provision of site-specific placement becomes a technical consideration. placement of the human tissue derived exosomes in a transgenic mouse calvarial defect model did not demonstrate bridging bone across the defect. exosomes loaded with pten-interfering rna enables functional recovery in rats after complete spinal cord transection daniel offen a , nisim perets a , shaowei guo b , oshra betzer c , rachela popovtzer c and shulamit levenberg b a tel aviv university, tel aviv, israel; b technion, haifa, israel, haifa, israel; c bar ilan university, israel, ramt gan, israel introduction: complete spinal cord transection is a debilitating disease that usually leads to permanent functional impairments, with various complications and limited spontaneous recovery. the current investigation of molecular mechanisms controlling axon regeneration, (e.g., signalling networks and environmental cues), led to new strategies to enhance axonal regeneration. we have previously shown that intranasal administration of mesenchymal stem cells derived exosomes (msc-exo), cross the blood-brain barrier and significantly ameliorate motor and behavioural phenotype in several animal models of neurotrauma and neuropsychiatric disorders. methods: msc-exo were isolated from human bone marrow and were loaded with phosphatase and tensin homolog small interfering rna (pten-sirna). the exosomes were given intranasally to rats two hours after complete spinal cord transaction. eight weeks later we followed the motor function and histology and electrophysiology study was performed in order to reveal the connectivity and the biochemical changes in the treated rats. results: we demonstrate that intranasal (in) administrations of msc-derived exosomes could penetrate the blood-brain barrier, home selectively to spinal cord lesion via chemotaxis, and integrated in neurons within the lesion. furthermore, in rats with complete spinal cord transection, msc-exo loaded with pten-sirna silenced pten protein expression in the lesion and promoted robust axonal regeneration and angiogenesis, companied with decreased astrogliosis and microgliosis. moreover, the intranasal treatment partially restored electrophysiological and structural integrity, and most importantly, enabled the remarkable functional recovery and significant improvement in their movements. summary/conclusion: this rapid, non-invasive, approach, using cell-free nano-swimmers carrying molecules to target pathophysiological mechanisms suggest novel strategy for clinical translation to spinal cord injury and beyond. a novel umbilical cord derived wharton's jelly formulation for regenerative medicine applications introduction: musculoskeletal injuries have traditionally been treated with activity-modification, physical therapy, pharmacological agents and surgical procedures. these modalities have limitations, as well as potential side-effects. over the last decade, there has been an increased interest in the use of biologics for regenerative medicine applications (rma), including umbilical cord (uc) derived wharton's jelly (wj). despite this increase, there is insufficient literature assessing the amount of growth factors, cytokines, hyaluronic acid (ha) and extracellular vesicles (ev) including exosomes in these products. the purpose of this study was to develop a novel wj formulation and evaluate the presence of growth factors, cytokines, ha and ev including exosomes. methods: wj was isolated from human-uc obtained from consenting c-section donors and formulated into an injectable form. randomly selected samples from different batches were analysed for sterility testing and quantified for presence of growth factors, cytokines, ha and particles in ev size range. the results showed all samples passed the sterility test. growth factors including igfbp , , , and , tgfα, pdgf-aa were detected. expression of several immunomodulatory cytokines, rantes, il- r, il- , were also detected. expression of pro-inflammatory cytokines mcsfr, mip- a; anti-inflammatory cytokines tnf-ri, tnf-rii, il- ra; and homoeostatic cytokines timp- and timp- were observed. cytokines associated with wound-healing, icam- , g-csf, gdf- , and regenerative properties, gh were also expressed. high concentrations of ha were observed. particles in the ev size range ( - nm) were detected and were enclosed by the membrane, indicative of true ev. summary/conclusion: our results confirmed the presence of numerous growth factors, cytokines, ha and ev in the wj formulation. more studies are underway to confirm the presence of exosomes in detected ev using exosome-specific markers. we believe the presence of multiple factors within one wj formulation may play a role in reducing inflammation, pain and augment healing of musculoskeletal injuries. this offers a potential expanded use for rma. funding: this study was funded by biointegrate llc, new york, ny, usa. collagen sponge loaded with mesenchymal stem cell-derived small extracellular vesicles promote robust bone regeneration shang jiunn chuah a , chee weng yong a , jacob ren jie chew a , ruenn chai lai b , yi ann cheow a , raymond chung wen wong a , asher ah tong lim a , sai kiang lim c and wei seong toh d introduction: mesenchymal stem cell (msc) therapy has demonstrated effective bone regeneration in clinical studies. however, the therapeutic efficacy of mscs have been attributed to the secretion of extracellular vesicles (evs), particularly - nm small evs (sevs). here, we investigate the efficacy of msc-sevs loaded in collagen sponge in the regeneration of critical-sized calvarial defects in immunocompetent rats. methods: sevs were isolated from conditioned medium of human mscs and stored at − c. calvarial defects of -mm diameter were surgically created on thirty-two -week-old male sprague-dawley rats. these rats were then randomly assigned to groups (n = rats/group): defects treated with collagen sponge containing μg of sevs in μl saline (cs/sevs) and defects treated with control collagen sponge containing an equivalent volume of saline (cs/control). at and -week post-surgery, the calvarial bone samples was harvested for analyses by micro-computed tomography (micro-ct), histology, immunohistochemistry and histomorphometry. results: at -week post-surgery, micro-ct analysis showed little bone formation at the defect site in both cs/sevs and cs/control groups. no statistical differences were observed in micro-ct and histology scores in both groups. interestingly, cs/sevs group showed significantly higher osteocalcin (ocn)+ area of . ± . % than that of cs/control group ( . ± . %; p = . ). cd + microvessels at sizes ≤ µm and > µm in cs/sevs group ( . ± . and . ± . microvessels/hpf) were also significantly higher than that of cs/control ( . ± . and . ± . microvessels/hpf; p = . and p = . respectively). by weeks, cs/sevs group displayed enhanced new bone formation that completely bridged the calvaria defect. in contrast, rats in cs/control showed limited bone formation. consequently, cs/ sevs group displayed a micro-ct score of . ± . which was significantly better than that of cs/control group ( . ± . ; p = . ). cs/sevs group also exhibited >twofold increase in bone volume, and improved bone quality with higher trabecular thickness and number, and smaller separation (p < . ), compared to cs/control group. consistently, cs/sevs group displayed a significantly better histology score of . ± . than that of cs/control ( . ± . ; p = . ). moreover, cs/sevs group showed significantly higher ocn+ area of . ± . % than that of cs/control group ( . ± . %; p = . ). summary/conclusion: this study demonstrates that single-stage implantation of collagen sponge loaded with ready-to-use msc sevs can promote robust bone regeneration in a rat calvarial defect model. funding: national university of singapore, r , national medical research council singapore, r . immunomodulatory potential of extracellular vesicles derived from mesenchymal stromal cells introduction: extracellular vesicles (evs) derived from mesenchymal stem/stromal cells (mscs) are promising new agents in regenerative medicine and immunotherapy. considering that independent msc-ev preparations might differ in their therapeutic function, we have set up a functional assay allowing testing for the potential immunomodulatory properties of independent msc-ev preparations. methods: human peripheral blood-derived mononuclear cells (pbmcs) were pooled from up to different healthy donors warranting high allogeneic cross-reactivity, even following an optimized freezing and thawing procedure. after thawing, mixed pbmcs were cultured for days in the absence or presence of msc-evs. thereafter, cell morphologies were documented, supernatants were harvested for cytokines quantification and cells were phenotypically characterized by flow cytometry. by analysing the expression of a collection of different lineage and activation markers, we selected a panel of antigens apparently being regulated by msc-ev preparations considered to be therapeutically active. results: we observed that in the presence of active msc-ev preparations more cd + (monocytes) are recovered from the mlr assay than in corresponding control samples. focusing on t cells, we learned that active msc-ev preparations reduced the content of cd and cd t cells expressing activation markers like cd and cd . summary/conclusion: the mlr assay allows elaborated functional testing of immunomodulatory activities of given msc-ev preparations. currently, we are comparing the immune modulatory capabilities of evs derived from distinct sources and optimize the marker panel to distinguish discrete immune cell subtypes such as different cd cell types, i.e. th , th , th and tregs. extracellular vesicles in platelet-rich plasma: dependency on sample processing zala jan a , saba battelino b , darja božič c , matej hočevar d , ales iglič e , marko jeran c , manca pajnič a , ljubiša pađen a , domen vozel f and veronika kralj-iglič a introduction: platelet-rich plasma (prp) proved effective in regenerative medicine. numerous protocols for its preparation and application are available in the published literature. prp possesses important immune, haemostasis and regenerative factors, however, the mechanisms of their action are yet poorly understood. extracellular vesicles (evs) could be one of the important factors that would contribute to the beneficial effects of preparations. this study was performed as a part of a registered randomised controlled clinical trial (nr: nct ). prp was used to treat chronic middle ear inflammations. here we present the results of prp analyses from blood samples of volunteers with no record of disease. methods: plasma obtained from ml of blood was depleted of erythrocytes and enriched with other particles by repetitive centrifugation of samples. flow cytometry (fcm) was employed to monitor particle contents (cells and smaller particles) throughout the sample processing. the platelet gate was divided into two parts: intact platelets and smaller particles. identity and morphology of particles in the preparations were examined by scanning electron microscopy (sem). standard laboratory tests of blood were performed. results: sem images revealed the presence of heterogeneous population of particles in the preparation of prp, most of which were activated and partially fragmented platelets. the population of smaller particles measured with fcm, was identified as evs. the erythrocyte sedimentation rate was statistically significantly correlated to the volume of plasma obtained in the initial centrifugation step (r = , , p < , ) and to the concentration of evs (r = , ; p < , ). time from sample collection to the preparation of prp was negatively correlated with the concentration of platelets in prp and positively with the concentration of evs (r = , , p < , ). platelet concentration in preparation samples was found to depend on the concentration of platelets in the blood and parameters of sample processing connected with larger centrifugal and shear forces on the samples during centrifugation. these include: sample volume, the size and shape of the centrifuge tube and the distance of the sample from the rotor axis. summary/conclusion: evs are gradually forming upon activation and degradation of cells in the sample throughout the sample processing. optimal processing may importantly contribute to the healing properties of preparation. funding: authors acknowledge support from the european union's horizon research and innovation program under grant agreement no. (ves us project) and slovenian research agency (arrs, grants p - , p - , j - ). satellite cell-derived extracellular vesicles as a therapeutic for mitochondrial dysfunction in duchenne muscular dystrophy duchenne muscular dystrophy (dmd). sc-derived extracellular vesicles (sc-evs) may unlock the therapeutic potential of scs by overcoming these limitations. to investigate their therapeutic potential, we assessed the ability of sc-evs to reverse mitochondrial dysfunction, a key pathological feature of dmd, in oxidatively-damaged c c and primary dmd myotubes. methods: scs from c mice were isolated and cultured. evs were isolated from the supernatant of scs via polyethylene glycol precipitation and characterized using nanoparticle tracking analysis. the ability of sc-evs to deliver protein cargo to c c myotubes, and the localization of the cargo once delivered, were analysed using fluorescence microscopy. to examine sc-ev potential to restore the function of damaged mitochondria, c c myotubes were treated with µm h o for h followed by treatment with . x sc-evs for h. separately, cultured dystrophic myotubes were treated with . × evs every h for h. in both sets of experiments, maximal oxygen consumption rate (max ocr) was measured via seahorse xf cell mito stress test. where appropriate, a t-test was performed to test for statistical significance (p < . ). results: based on estimated cell number and ev quantification, each sc released approximately . × ± . x evs/day. evs delivered protein cargo into myotubes within h. fluorescent labelling of intracellular mitochondria showed co-localization of delivered protein and mitochondria. incubation of myotubes with h o resulted in a % decline in max ocr relative to untreated myotubes. subsequent treatment with sc-evs resulted in a % increase in max ocr. treatment of undamaged myotubes with sc-evs had no effect on max ocr. primary dmd myotubes treated with sc-evs showed a % increase in max ocr relative to untreated dmd myotubes. summary/conclusion: sc-evs rapidly deliver proteins into myotubes, much of which co-localizes with mitochondria, and reverses mitochondria dysfunction in oxidatively-damaged and dystrophic myotubes. introduction: flow cytometry has been used extensively for analysis of ev particles stained with fluorescent antibodies directed to the known cell surface markers. quantitation of the surface markers in terms of the number of molecules or the number of antibodies bound per specific marker has remained one of the largest challenges in the ev research field. changes in instrument setup as well as changes in fluorescent antibodies from different vendors, all impact the relative mfi values for the same ev sample. in this work we report a standardization method of quantitating extra-cellular vesicle surface markers with mesf liposomes. methods: liposomes labelled with fitc fluorescent dye were prepared with a bd proprietary technology. dynamic light scattering analysis was used for size determination of the liposomes. bd facsaria™ fusion system, modified with a small particle side scatter module (sp ssc), was used for analysis of the labelled liposomes by flow cytometry. results: we created a set of nm fitc-modified liposomes of various fluorescent intensities with a known number of fitc molecules incorporated in each liposome intensity. the mfi values of each liposome population (intensity) had a linear relationship to the amount of fitc used for labelling the liposome nanoparticles, suggesting that no self-quenching of fitc fluorescence had occurred. the number for the fitc fluorophores for each liposome intensity was expressed in the units of molecules of equivalents soluble fluorochrome (mesf). a plot of mesf vs. the fluorescent intensity of the liposomes (mfi values) obtained from flow cytometry analysis provided a calibration curve, from which the fluorescent intensity (mfi value) of a stained ev sample can be converted to the number of fluorophores bound (mesf value) to the surface of the ev particles. summary/conclusion: by this approach, the mfi values of stained ev particles are converted to standardized mesf values that are independent of instrument variation, resulting in further improvement of inter-laboratory standardization. furthermore, utilization of liposomes with similar size and refractive index to ev particles simplifies the data evaluation and improves the accuracy of ev surface marker quantitation by flow cytometry. currently, other fluorescent dyes are being explored to expand the utility of mesf liposomes with other fluorescent colours. measuring cholesterol as a high-throughput method for quantifying extracellular vesicles introduction: the extracellular vesicle (ev) field currently lacks a high-throughput method for accurately quantifying evs in solution. ev quantification has traditionally relied on nanoparticle tracking analysis (nta), which is time intensive and indiscriminately counts non-ev particles, such as membrane fragments and protein aggregates. we have rigorously assessed two commercially available methods for measuring cholesterol, a major lipid component of the ev lipid bilayer, and evaluated the utility of these assays to quantify evs in minimally processed samples. methods: the amplex® red cholesterol assay and cedex bio ht were used to quantify cholesterol in ev samples via enzymatic oxidation, with dynamic ranges of - , ng/ml and - µl/ml, respectively. samples throughout various stages of purification were analysed, from clarified cell culture medium to highly purified evs separated on an iodixanol gradient. we evaluated several pre-processing methods, to remove non-ev cholesterol content prior to analysis. results: the amplex® and cedex bio ht assays were found to perform comparably for quantifying cholesterol in purified evs (r = . ). importantly, cholesterol quantification on purified ev samples, ranging from e to e particles/ml, correlated well with nta measurements (r = . ). both µm filtration or an additional , rcf centrifugation step following clarification removed cholesterol associated with cellular debris or other non-ev sources, allowing for accurate quantification of conditioned medium samples or ultracentrifugation pellets (ucp) instead of needing to rigorously purify samples with an iodixanol density gradient. summary/conclusion: cholesterol quantitation can be used to accurately estimate ev concentration, allowing for rapid characterization of samples from clarified cell culture supernatant to highly purified evs. this highthroughput analytical capability may enable more comprehensive assessment of methods to boost ev yield through mass screening of cell culture conditions. optimization of nanoparticle tracking analysis of extracellular vesicles isolated from plasma and bronchopulmonary lavage fluid of patients with non-small cell lung cancer introduction: recent studies show that tumourderived extracellular vesicles (evs) greatly influence the tumour microenvironment and impact the therapy. in non-small cell lung cancer (nsclc), bronchopulmonary lavage fluid (balf) appears to be a good source of tumour-derived evs, providing more accurate information about the tumour microenvironment than evs from plasma. so far there is a lack of accurate and standardized methods for ev quantification. fluorescence nanoparticle tracking analysis (fl-nta) is an emerging method of ev-analysis, allowing discrimination of evs and exosomes from impurities. here we perform an optimization of the fl-nta method to compare evs from plasma and balf of nsclc patients and healthy controls (nc). methods: evs were isolated using homemade sizeexclusion chromatography (sec) columns (plasma) and ultrafiltration or differential ultracentrifugation (balf). nta was performed using zetaview pmx (particle metrix) after ev-staining with membrane dyes or fluorescence-labelled antibodies against typical ev-marker (cd , cd , cd ). results: nta scatter measurements showed a higher total particle concentration in plasma than in balf. however, membrane-specific staining showed a much greater purity of ev-preparations from balf, where nearly % of the particles detected in scatter mode showed positive membrane-staining. in contrast, only around - % of particles in the plasma ev-preparations were positive for the membrane dyes. fluorescence-staining for ev surface marker requires further optimization to obtain reproducible results. summary/conclusion: classical nta using only the scatter mode fails to discriminate between evs, lipoproteins and protein aggregates. for ev-analysis from complex biofluids like plasma, fla-nta and staining for specific ev marker is necessary to receive reliable data. balf seems to be a better source of tumourderived evs than plasma, since the obtained ev-preparations show a higher purity. improving conditions for fluorescence-staining and nta measurement of evs from plasma and balf of nsclc patients will provide an additional method for quantifying and phenotyping of evs. introduction: the exoviewer platform currently enables the user to capture extracellular vesicles (ev) by means of surface antigen-specific antibodies (e.g. targeting tetraspanins), making possible the enumeration of individual particles using single-particle interferometric reflectance imaging sensor (sp-iris, interferometric) imaging as well as fluorescence. currently, through interferometric imaging particles smaller than nm cannot be detected, while fluorescently stained ev smaller than nm can be well resolved. further, it is conceivable that small ev contain antigen numbers in the single digits, making antigen-specific immunostaining a challenge. to further characterize ev populations of different sizes and surface marker composition, it would be highly advantageous to target the vesicular nature of the detected particles linked to a fluorescence readout. methods: the goal of this project is to detect ev with a probe that is ubiquitously distributed across the surface (or lumen) of the vesicle. small ( - nm) ev present fairly distinctive lipid membrane features in the extracellular environment, turning the ev membrane into a "universal" marker, and as such may serve as an alternative marker that is complementary to canonical ev surface markers. results: here we present data on successfully staining ev with the membrane dye di- -anepps (di- ) and the luminal dye calcein-am. we demonstrate that ev from different sources can be efficiently stained with either dye, allowing the quantitative characterization of ev in an unbiased manner using exoviewer's fluorescence mode. while both dyes certainly have their own unique strengths, they exhibit the wanted linear correlation of ev staining versus concentration. further, both dyes are compatible with subsequent immunostaining applications, allowing the user to target specific surface or luminal markers (di- ). summary/conclusion: while a large-panel screening featuring other powerful dyes is continuously ongoing, the current data support the notion of providing the experimenter with a reference for total particle count and at the same time fully exploring the larger dynamic range of the fluorescence mode. moreover, the universal probe will enable the user to correlate intensity and particle size measurements, thereby significantly improving the exoviewer platform and its applications. membrane labelling is essential for the identification and quantification of extracellular vesicles via facs introduction: extracellular vesicle (ev) research is challenged by the lack of standard protocols to identify and distinguish between exosomes and ectosomes being released via exocytosis or plasma membrane shedding, respectively. analysis of small ev populations requires high-resolution technology and can be further improved using fluorescent labels such as carboxyfluorescein diacetate succinimidyl ester (cfse). at the inner leaflet of the plasma membrane, cfse is cleaved enzymatically resulting in covalent binding of the dye. in this study we optimized the conditions for membrane labelling of evs and their subsequent detection by flow cytometry to obtain a maximum yield of intact evs. methods: using sequential centrifugation, we separated ev subpopulations from supernatants of colo pancreas carcinoma cells based on size and mass. after , x g centrifugation, we reconstituted evs from the pellet. we used cfse for ev detection and analysed the expression of tetraspanins by facs to confirm the lipid bilayer structure. furthermore, we determined size distribution of evs by nanoparticle tracking analysis (nta) and electron microscopy. detecting evs as cfse+ events, we quantified our samples and investigated the impact of threshold adjustment on ev quantification. results: after high speed centrifugation of cell free supernatants, we identified cfse+ events as evs, which appeared as round structures under the microscope, and ranged from to nm in size. interestingly, tetraspanin markers cd and cd were detectable only on a subpopulation of purified evs, suggesting heterogeneity of our preparations. for sufficient labelling of evs, minimal temperature variations and short incubation times correlated with ev stability. of note, threshold adjustment significantly improved the sensitivity of the flow cytometer for the detection of labelled evs and hence, is central for data comparability. summary/conclusion: protocol standardization is of major importance for the use of evs as diagnostic markers in liquid biopsies. funding: this project has been supported in part by annelise-asmussen foundation, luebeck (grant ), leo pharma germany (grant ). surface plasmon field-enhanced fluorescence spectroscopy (spfs) system for quantitative and qualitative extracellular vesicles total evaluation without any sample pretreatment introduction: the function of extracellular vesicle (ev) is interested in the immunology and oncology fields as a key transmitter for cellular communication. however, the conventional ev evaluation methods are required complicated evs preconcentration from the sample, its leads ev analysis uncertainty. in this study, we applied the spfs highly sensitive automated system for quantitative and qualitative ev evaluation without any sample pre-concentration and preparation step. methods: spfs automated system and plastic disposable sensor had been developed by konica minolta corporation in house. anti-membrane protein (cd , cd , cd ) antibody was chemically bonded on hydrophilic polymer which was immobilized through the gold thin film on the spfs sensor. the concentration of standard ev materials was evaluated by the qnano system before using. ev detection without preconcentrating was achieved by sandwich immunoassay step in microchannel round-trip flow reaction (tat min) with the spfs system, and elisa was adapted as a conventional standard method. after spfs highly sensitive fluorescent measurements step, extracted and detected ev were effectively recovered by using the recovery buffer reaction. results: the ev sensitivity performance between spfs and elisa clearly showed a significant difference, and the lod of spfs ( . particles/μl) method was estimated times superior to the lod of conventional elisa ( , particles/μl). the spfs calibration curve showed a wide dynamic range at least over logs as an additional specificity. spfs method also showed fine results in the dilution linearity test with high reproducibility under the serum/plasma sample condition. the data for recovery test of ev expected us that highly accurate measurement can be guaranteed under the condition of dilution about times or less even in the whole blood sample. after the spfs measurement, extracted ev on the spfs sensor chip could be effectively recovered and could be analysed nucleic acid which contains micro rna. summary/conclusion: spfs system might have great potential for quantitative and qualitative ev evaluation. our strategy with spfs system for ev proteomic and genomic profiling will be possible for applying to ev quality control as well as a novel biomarker development. identification of a novel compound that inhibits small ev secretion and tumour progression by a sensitive elisa screening. yunfei ma a , takeshi yoshida a , duc tuan nguyen a , kazutaka matoba b , katsuhiko kida b , taito nishino b and rikinari hanayama c a kanazawa university, kanazawa, japan; b nissan chemical corporation, tokyo, japan; c wpi nano life science institute, kanazawa university, kanazawa, japan introduction: small evs from tumour cells are known to promote tumour progression, therefore, it is expected to develop drugs that regulate small ev secretion, which can be used in clinical applications. methods: to identify such regulators, we first developed a sensitive elisa system for the quantification of small ev secretion using a high-affinity ev binding protein tim . by using this elisa system, we screened for small compounds that promote or inhibit small ev secretion using a drug-repositioning compound library (about , compounds). results: as a result, we identified eight promoters and two inhibitors, including compound a, which significantly reduced small ev secretion from various cell types without affecting cell growth. we further investigated the effects of compound a on a mouse model of osteosarcoma and found that compound a suppressed tumour progression efficiently. summary/conclusion: these data suggest that compound a would be useful not only for the characterization of small ev function but also for the clinical therapy against tumour progression, by inhibiting small ev secretion. introduction: for many years it was believed that several proteins such as cd , cd and flotillin- were unique for exosomes, however recent studies have shown that several of these markers also can be present in other subpopulations of evs (kowal et al pnas ) . furthermore, few markers have been identified as uniquely present in microvesicles. the aim of this study was to in depth compare the proteome of microvesicles and exosomes. methods: mda-mb- -luc-d h , -d h ln and -bmd a were cultured in ev-depleted media. microvesicles ( , x g, min) and exosomes ( , x g . h) were isolated using a combination of differential ultracentrifugation and a density cushion (~ . g/ml). purity and yield of evs were determined by nanoparticle tracking analysis (nta), western blot, and electron microscopy (em). quantitative mass spectrometry (tmt-lc-ms/ms) was used to identify differently enriched proteins in microvesicles and exosomes (n = x cell lines). results: in total proteins were quantified, with being quantified in all samples. in total and proteins were significantly upregulated in exosomes and microvesicles, respectively. go terms associated with the proteins significantly upregulated in exosomes were "extracellular exosome" and "plasma membrane", while the microvesicle proteome was associated with "membrane" and mitochondrion". in exosomes tetraspanins, annexins, escrt and rab proteins were significantly upregulated. in contrast, proteins that were upregulated in microvesicles were involved in protein translocation into the mitochondrial membrane (timm and tomm proteins), in cytokinesis, and in micos complex. however, flotillin- was not differently expressed in the ev subtypes. summary/conclusion: this study identifies several proteins to be differently enriched in exosomes and microvesicles. several of the proteins suggest recently by kowal and colleagues, such as adam and mitofilin could be validated. additionally several novel proteins could be identified. identifying markers separating microvesicles and exosomes is of high importance for the ev field and future studies will have to validate them also in other cells to determine if they are generic. introduction: the cellular elements composing the lining of brain ventricles have drawn much attention from neuroscientists, especially the role of subependymal cells in neurogenesis, but the role of ependymal cells in brain function and disease is still neglected. our objective is to study the morphological aspects of rat brain ventricles and the ependymal cells as analysed by transmission and field emission scanning microscopy in normal or ischaemic rats. methods: for this purpose, male wistar rats were submitted to minutes of global brain ischaemia and divided into two groups: a) sham-operated animals and b) saline-treated ischaemic animals. all animals were allowed to survive for seven days. all procedures were approved by the ethics committee of the federal university of são paulo ( / ). transmission and scanning electron microscopic analysis of lateral brain ventricles were done in buffered , % glutaraldehyde/ %formaldehyde perfused brains. cerebrospinal fluid was collected for nta analysis. results: the morphological characterization of brain ventricle revealed a slight rarefaction of ciliary tufts of animals submitted to ischaemia when compared to normal animals. field emission electron microscopy revealed the secretion of vesicles by the ependymal cilia in the lateral ventricle. size and concentration of particles in the cerebrospinal fluid was confirmed by nta and transmission electron microscopy. summary/conclusion: our results are unprecedented and bring innovative potential regarding the role of extracellular vesicles in both the physiology and pathogenesis of the nervous system. these data may also contribute to the development of new technologies for diagnosis and therapy of chronic degenerative diseases. introduction: the function of mitochondria relies on precise and effective quality controls. neurons have high metabolic demands and employ multiple mechanisms to ensure functional mitochondria. we investigated mitochondrial vesiclesa less understood quality control mechanism for mitochondriaand assessed the effect of cellular stress. methods: we surveyed mitochondrial vesicles in rat and planaria brains with electron microscopy. we quantified these vesicles with serial-section electron microscopy (fib-sem). we also conducted confocal microscopy with airyscan analysis of cultured neurons expressing fluorescently tagged mitochondrial markers. results: electron microscopy showed the ultrastructure of various types of mitochondrial vesicles. serial-section electron microscopy revealed the d ultrastructure of mitochondrial vesicles and their prevalence in neurons. confocal microscopic analysis showed increased numbers of mitochondrial vesicles in neurons under mild stress. summary/conclusion: our findings provide direct structural evidence for mitochondrial vesicles in neurons and their abundance in response to neuronal stress. their detection in the extracellular compartment (evidence for which is expected to be presented by the time of isev) may allow for development of biomarkers for mitochondrial health, with relevance to numerous pathologic conditions. from endosomes, might be involved in the impairment of rna, specific feature of als disease. combining high-resolution flow cytometry and surface marker analysis using an automated platform to study extracellular vesicle in cerebrospinal fluid unity health toronto, toronto, canada introduction: there is growing enthusiasm that extracellular vesicles (evs) carry the potential for a variety of applications in medicine. as biomarkers, evs may aid clinicians in the evaluation of diagnoses, disease progression, or even response to therapy. however, proper characterization of the amount, size, and phenotype of evs in a given sample remains challenging due to their sub-micrometre size and heterogeneity. over the last years, technologies, including high-sensitivity flow cytometry and automated platforms that simultaneously assess ev amount, size, and phenotype, have matured, providing new opportunities to study evs for future clinical applications. using such technologies to analyse cerebrospinal fluid (csf), which is in direct contact with the brain and spinal cord, may yield valuable insights into neurological disease processes. while there is often uncertainty about the exact source of evs in a biological sample, cd has emerged as a surface marker that suggests a neuronal origin. methods: csf samples that had been stored at - degrees celsius for advanced biomarker studies were analysed using two distinct approaches. a becton, dickinson and company (bd) aria iii flow cytometer was converted into using violet side scatter (ssc) for improved detection of evs with instead of nm ssc. for the combined analysis of amount, size, and phenotype, samples were analysed with the nanoview bio r platform. phenotype analysis included probing for the classic tetraspanins associated with exosomes (cd , cd , cd ) and the neural cell adhesion molecule l (cd ). results: flow of csf samples showed similar vesicle counts in control vs. disease and an increase of counts in later disease stages when neurodegeneration is thought to be more prominent. all csf samples showed some binding to classic exosomal markers (cd , cd , cd ). the sample taken at the latest time point showed relatively high vesicle counts, overall larger vesicle size, and abundant cd binding. interestingly, the cd positive evs were not positive for any of the classic exosomal markers (cd , cd , and cd ). summary/conclusion: this data supports the notion that analysing the amount, size, and surface markers of evs in csf can reveal intriguing dynamics in such basic ev characteristics over time and suggests important differences between ev populations in different disease stages. while previous studies indicated that cd could identify an ev to be of neuronal origin, it remains to be determined whether such specific surface markers will emerge as clinically relevant tools to support the evaluation of people affected by neurological diseases. a distinct microrna signature in plasma derived small extracellular vesicles of different neurodegenerative diseases introduction: exploring identifying robust biomarkers is essential for early diagnosis of neurodegenerative diseases. blood stream transports large (levs) and small extracellular vesicles (sevs), which are extracellular vesicles of different sizes and biological functions that are transported in blood. aim of our study was to investigate mrna/mirna signatures in plasma derived levs and sevs of amyotrophic lateral sclerosis (als), alzheimer's disease (ad), parkinson's disease (pdpd), fronto-temporal dementia (ftd) and alzheimer's disease (ad) patients. methods: levs and sevs were isolated from plasma of patients and healthy volunteers (ctr) by ultracentrifugation and rna was extracted. whole transcriptome and mirna libraries were prepared with truseq stranded total rna kit and truseq small rna library kit (illumina). results: our data suggested that the rna cargo in levs and sevs varies among different diseases. mirna analysis in sevs provided the most informative disease specific signatures, while whole transcriptome analysis did not show any specific signature. als was characterized by a small but specific group of circulating mirnas. mirnas profiling revealed that pd and ftd can be subgrouped in two classes while ad appears to be a homogeneous disease population. furthermore, mirnas profiling show the presence of overlaps in the signatures between the analysed diseases. mirna profiling in levs is similar to that observed in sevs, although in levs the overall differences between diseases are less marked. summary/conclusion: in this study we have demonstrated that mirnas are the most interesting subpopulation of transcripts transported by plasma derived sevs since they discriminate a disease from the other and they can provide a signature for each neurodegenerative diseases. may be linked with apoe genotype, we investigated the possible effect of apoe genotype on brain-derived evs (bdevs) and their protein and rna molecular cargo. methods: cortical brain tissues of ad patients with different apoe genotypes [ε /ε (n = ), ε /ε ( ), ε /ε ( ), ε /ε ( )] and non-ad controls (n = ) were obtained. bdevs were separated by size exclusion chromatography plus ultracentrifugation (uc) and characterized per misev . proteins were analysed by mass spectrometry. after protein identification, data were normalized using the cyclicloess method and analysed by principal component analysis (pca). nested factorial design highlighted differentially expressed proteins. rna from bdevs was extracted by mirneasy mini kit. small rna libraries were constructed using the ion total rna-seq kit and sequenced on the ion torrent s ™ using ion™ chips. reads were aligned to human reference transcriptomes using bowtie. differential gene expression was quantified by edger and limma. results: among proteins dysregulated in ad bd-sevs, several have reported roles in ad, e.g., microtubule-associated protein tau and peroxiredoxin- . regarding apoe genotypes, proteins were differentially expressed between ε carriers (ε /ε and ε /ε ) with non ε carriers (ε /ε and ε /ε ). however, ev markers did not differ by apoe genotype. in contrast to protein cargo of bdevs, the overall small rna expression pattern was similar among ad patients with different apoe alleles and non-ad patients. only a few mirnas showed different abundance level between ε /ε and ε /ε groups, or between ad and non-ad groups. summary/conclusion: bdevs carry proteins and mirnas related to ad development and apoe genotypes. further verification of protein and rna expression in brain and plasma derived evs may reveal mechanisms of ev function in neuroinflammation and develop biomarkers for ad disease. funding: this project was funded by mh . efficient pathology spread by extracellular vesicles from human brain tissues in mouse brain and tissue cultured neurons: transmission and propagation to gabaergic neurons however, whether human brain-derived evs induce tau pathology has not yet been characterized in the mouse brain. here, we assess the mechanisms of disease spread after intrahippocampal injection of human brainderived evs into the aged mouse model. methods: ev-enriched fractions were isolated from unfixed frozen human brain samples from ad, prodromal ad (pad), control (ctrl) cases, and tau knockout (tko) mouse brains. isolated evs containing pg of human total tau were sterotaxically injected into the right outer molecular layer of the dentate gyrus of months-old c bl/ female mice. . months after the injection, hippocampal slices were prepared for whole-cell patch clamp recordings of ca pyramidal neurons were undertakent. hippocampi were analysed with immunohistochemistry using phosphorylated-tau (p-tau) epitopes including at . evs were examined for protein composition by protein mass-spectroscopy, the neuronal uptake in vitro, and structural analysis by the atomic force microscopy (afm). results: semiquantitative brain-wide immunohistochemistry of p-tau revealed that inoculation of ad or pad-evs induced tau propagation throughout the hippocampus, including the dentate gyrus, ca and ca subregions. at was localized primarily in gad + gabaergic neurons in pad and ad evs groups, accompanied with reduced amplitude of inhibitory postsynaptic currents and excitatory-inhibitory ratio in amplitube of postsynaptic currents in ca pyramidal neurons in pad evs. afm analysis showed higher density of tau oligomers in both ad and pad evs while only ad evs showed significantly higher neuronal uptake compared to ctrl evs. finally, proteomic analysis showed that ad evs are enriched in disease and glia-related molecules compared to ctrl evs, which may contribute to their enhanced neuronal uptake. summary/conclusion: intracranial injection of ad or pad evs induced p-tau accumulation primarily in gabaergic neurons throughout the hippocampus, resulted in higher uptake by neurons, and tau oligomer conformation, indicating of their pathogenic potency as seeding factors. gabaergic neuronal dysfunction in the hippocampal neuronal circuitry reported in early ad brains could be attributed to specific ev mediated tau propagation in this cell type, a phenomenon meriting further investigation and validation. funding: nih rf ag , nih r ag , nih r ag , cure alzheimer's fund, brightfocus foundation, curepsp, coins for alzheimer's research trust introduction: extracellular vesicles (evs) are released by cells of the central nervous system as a result of injury, including mild traumatic brain injury (mtbi). since mtbi may alter circulating levels of evs, this study aimed to investigate differences in circulating ev numbers between contact sport athletes with and without acute mtbi. methods: circulating evs containing cd (cd + ev), cd (cd + ev), and neural cell adhesion molecule (l cam+ev) were analysed in young, male athletes with or without mtbi ( - yo, n = per group). sodium citrate-treated blood samples were obtained from athletes with mtbi within -hours of injury and from control athletes free of mtbi for one year. athletes were best matched for age and history of prior mtbi. samples were double-centrifuged to obtain platelet-poor plasma and stored at − °c until analysed. quantification of evs was performed using a spectral flow cytometer. the study was approved by temple university's irb, and all athletes provided written informed consent. results: mann-whitney u tests showed that population percentages of small size ( - nm) cd + ev, cd + ev and l cam+evs were significantly higher in mtbi athletes (mean rank: . , . , . ) than controls (mean rank: . , . , . ) (u = . , p = . ; u = . , p > . ; u = . , p > . , respectively). population percentages of large size ( - nm) cd + ev, cd + ev and l cam+evs were also significantly higher in mtbi athletes (mean rank: . , . , . ) than controls (mean rank: . , . , . ) (u = . , p = . ; u = . , p > . ; u = . , p > . , respectively). there were no significant differences between percentages of evs associated with blood brain barrier function (cd + ev) or platelets (cd a+ev) among mtbi athletes or controls. introduction: parkinson's disease (pd) is characterized by clinical heterogeneity, different rates of progression and absence of definitive biomarkers. extracellular vesicles (evs) are easily isolated from plasma and play a central role in intercellular communication which is highly relevant for inflammatory processes implicated in protein misfolding-related neurodegenerative disorders. thus, we characterized distinctive plasmatic ev subpopulations of pd and atypical parkinsonisms (ap) patients, with the aim to identify candidate biomarkers among evs surface membraneproteins. methods: plasmatic evs were collected from pd, matched healthy controls (hc), ap with multiple system atrophy (msa) and ap with tauopathies (ap-tau). evs were quantified by nanoparticle tracking analysis. the expression of ev-surface markers, related to inflammatory and immune cells, were measured by macsplex and correlated to clinical scales. a diagnostic model based on ev markers expression was built via supervised machine learning algorithms and validated in an external cohort ( pd, hc, msa, ap-tau). the cantonal ethics committee approved the study protocol. all enrolled subjects gave written informed consent. results: pd showed the highest ev concentration compared to others groups. pd and msa displayed a greater pool of overexpressed immune markers compared to ap-tau. ev antigens correlate to cognitive impairment and disease gravity in pd and msa. the roc curve analysis of a compound ev marker showed optimal diagnostic performance for pd (auc . ; sensitivity . %, specificity . %) and msa (auc . ; sensi-tivity %,specificity . %)andgoodaccuracyforap-tau (auc . ; sensitivity . %, specificity . %). a diagnostic model based on ev markers expression, cor-rectlyclassified . %ofpatientswithreliablediagnostic performance after validation in an external cohort ( % of accuracy). summary/conclusion: this analysis of multiple immune surface markers of circulating evs in pd and ap well captured the clinical heterogeneity of pd and showed optimal diagnostic performance. furtherly it suggests a different immune dysregulation in pd and msa vs. ap-tau, to be confirmed by functional analysis in experimental models of disease. funding: supported by abreoc. separation and characterization of extracellular vesicles from human cerebrospinal fluid introduction: extracellular vesicles (ev) are released from cells to the surroundings and are found in human biofluids, where they constitute promising targets for novel biomarker identification. ev have been found in cerebrospinal fluid (csf) where they may provide with markers for neurological diseases. here, we aimed at purifying and characterizing ev from human csf. methods: csf was collected by lumbar puncture from patients with amyotrophic lateral sclerosis. patients gave written consent and studies were agreed by the local ethics committee. csf was fractionated by ultrafiltration (vivaspin, cut-off , ), and size-exclusion chromatography (sec; qevsingle izon science). eluted fractions were analysed by dynamic light scattering (dls) and electron microscopy. proteins were analysed by immunoblotting and nano-liquid chromatographytandem mass spectrometry. results: ev eluted in early fractions ( + ) after the sec void volume as evaluated by detection of cd and cd markers (immunoblotting) and annexin a (peptide mapping by nanolc-ms/ms). there, nanoparticles around nm were identified by dls. in agreement, electron microscopy showed ev with characteristic shape and sizes typically between and nm, with average diameter ± nm. cd was visualized by immunocytochemistry at the surface of ev around nm. on the other hand soluble proteins igg and albumin eluted in later fractions. curiously, galectin- binding protein (lgals bp or k) was also partially detected in early-eluting fractions as nanoparticles of irregular shapes and heterogeneous sizes typically between and nm; some of those nanoparticles had ring-like appearance. occasionally k also appeared on ev of variable dimensions. summary/conclusion: in conclusion, ev from the csf may be separated from soluble proteins and small molecules by a combination of ultrafiltration with sec fractionation. however, using this strategy a population of k-containing nanoparticles co-eluted with ev from the csf. further separation techniques need to be applied to separate ev from k nanoparticles to investigate their individual physiological relevance and biomarker potential. introduction: extracellular vesicles (ev) are released from cells to the surroundings and are found in human biofluids, where they constitute promising targets for novel biomarker identification. ev have been found in cerebrospinal fluid (csf) where they may provide with markers for neurological diseases. here, we aimed at purifying and characterizing ev from human csf. methods: csf was collected by lumbar puncture from patients with amyotrophic lateral sclerosis. patients gave written consent and studies were agreed by the local ethics committee. csf was fractionated by ultrafiltration (vivaspin, cut-off , ), and size-exclusion chromatography (sec; qevsingle izon science). eluted fractions were analysed by dynamic light scattering (dls) and electron microscopy. proteins were analysed by immunoblotting and nano-liquid chromatographytandem mass spectrometry. results: ev eluted in early fractions ( + ) after the sec void volume as evaluated by detection of cd and cd markers (immunoblotting) and annexin a (peptide mapping by nanolc-ms/ms). there, nanoparticles around nm were identified by dls. in agreement, electron microscopy showed ev with characteristic shape and sizes typically between and nm, with average diameter ± nm. cd was visualized by immunocytochemistry at the surface of ev around nm. on the other hand soluble proteins igg and albumin eluted in later fractions. curiously, galectin- binding protein (lgals bp or k) was also partially detected in early-eluting fractions as nanoparticles of irregular shapes and heterogeneous sizes typically between and nm; some of those nanoparticles had ring-like appearance. occasionally k also appeared on ev of variable dimensions. summary/conclusion: in conclusion, ev from the csf may be separated from soluble proteins and small molecules by a combination of ultrafiltration with sec fractionation. however, using this strategy a population of k-containing nanoparticles co-eluted with ev from the csf. further separation techniques need to be applied to separate ev from k nanoparticles to investigate their individual physiological relevance and biomarker potential. release of extracellular vesicles from platelets requires platelet-platelet interaction aleksandra gąsecka a , naomi c. buntsma b , sytske talsma c , krzysztof j. filipiak d , rienk nieuwland e and edwin van der pol f introduction: arterial thrombosis is a major and global cause of human death and disability, but a biomarker for early-diagnosis of thrombosis is absent. platelet activation and aggregation are the first steps of plateletrich thrombus formation, but their relative contribution to platelet extracellular vesicles (pevs) release is unknown. methods: to study the relation between pev release and platelet interaction (aggregation), citrate-anticoagulated whole blood (wb) from healthy donors was diluted , , , and -fold and activated by μm thrombin-receptor activating peptide (trap). in addition, undiluted wb and -fold diluted wb, which totally blocked pev release, were activated with various trap concentrations. concentrations of pevs (cd + and cd +, cd p + > nm) and activated platelets (cd +, cd p+ > nm) were measured by flow cytometry (apogee a -micro). platelet aggregation was assessed using impedance aggregometry. results: a -fold dilution of wb blocked both aggregation and the release of pevs. compared to baseline, activation of undiluted wb with trap increased the concentrations of cd + . -fold and cd +-cd p + pevs . -fold. the concentration of cd + (r = . ) and cd +-cd p+ (r = . ) pevs as well as platelet aggregation (r = . ) scaled inversely (reciprocal) with the dilution of wb. further, we found a linear correlation between the % of activated platelets and the concentration of cd + (r = . ) and cd +, cd p+ (r = . ) pevs in undiluted wb, which was absent in -fold diluted blood (r < . ). summary/conclusion: the absence of aggregation and pev release upon platelet activation in -fold diluted blood shows that aggregation directly depends on the distance between platelets, which is confirmed by the reciprocal relationship between pev release and blood dilution. because pevs are only released when platelet activation is followed by aggregation, pevs are a potential early biomarker of thrombosis. funding: ag is supported by the national science centre, research programme preludium / / n/nz / . evdp is supported by the netherlands organisation for scientific research -domain applied and engineering sciences (nwo-ttw), research programmes veni . age-dependent alteration in concentration and size distribution of extracellular vesicles in plasma of normotensive and hypertensive rats kosuke otani, muneyoshi okada and hideyuki yamawaki laboratory of veterinary pharmacology, school of veterinary medicine, kitasato university, towada, japan introduction: spontaneously hypertensive rats (shr) are the most widely used animal model of human essential hypertension. we previously reported that plasma small extracellular vesicles (sevs) in shr regulate systolic blood pressure, however, the mechanism has not been clarified. in the present study, we compared the concentration and size distribution of plasma evs (sevs and large evs) from young and aged normotensive wistar kyoto rats (wky) and shr. methods: heparin-anticoagulated plasma was collected from male wky and shr at ~ -(young) and -(aged) week-old. large evs were isolated from the plasma by centrifugation ( x g). sevs were isolated by ultracentrifugation ( , x g) following precipitation with polyethylene-glycol. the concentration and size distribution of sevs and large evs were measured by a tunable resistive pulse sensing analysis. results: there was no significant difference in the total concentration of plasma sevs between wky and shr or between young and aged rats. the mean diameter of plasma sevs from aged rats was larger than that from young rats in both wky and shr. also, the number of particles with a diameter of smaller than nm in plasma sevs from aged rats was lower than that from young rats. the concentration of plasma large evs from aged rats was higher than that from young rats in both wky and shr. there was no significant difference in the size distribution of plasma large evs between wky and shr or between young and aged rats. summary/conclusion: the present results for the first time demonstrate that the concentration of plasma large-sized evs is increased by ageing, while there is no difference in the concertation and size distribution of evs between wky and shr. further research is required to clarify the cause of age-dependent alternation in plasma ev size distribution and its physiological meaning. microrna profiling of circulating extracellular vesicles is involved with susceptibility to age-related diseases: relevance to cardiovascular signalling in ageing process ionara rodrigues siqueira a , laura cechinel b , rachael batabyal c and robert freishtat c a universidade federal do rio grande do sul (ufrgs), porto alegre, brazil; b universidade federal do rio grande do sul, porto alegre, brazil; c children's national hospital, washington, usa introduction: ageing represents a central risk factor for several diseases, such as cardiovascular diseases. our hypothesis is that extracellular vesicles (evs) can be potential mechanism of spreading molecules, such as micrornas, involved with susceptibility to chronic age-related diseases and geriatric syndromes. in this context, the role of micrornas in age-induced detrimental changes in the cardiovascular system has been suggested. although evs can protect micrornas from endogenous rnases and internalization of these vesicles into cells is involved with cell communication, delivering micrornas even to distant tissues, the relationships between evs micrornas profile and chronic age-related diseases has not been evaluated. our aim was to investigate the microrna profile of circulating evs during ageing process and their downstream signalling pathways. methods: the ethics committee (ceua -comissão de Ética no uso de animais -ufrgs; nr. , ) approved all animal procedures and experimental conditions. male wistar rats of -and -month-old were used, and plasma was obtained from the trunk blood. evs were isolated with exoquick following the manufacturer's instructions. microrna was isolated from evs and then amplified. microrna was labelled using the flashtag biotin hsr rna labelling kit and profiled on affymetrix genechip microrna . arrays. ingenuity pathway analysis (ipa) was used to identify pathways regulated by significantly altered micrornas. results: microarray analysis revealed micrornas. of these micrornas, were differentially expressed between aged and young-adult animals, micrornas were significantly upregulated and were downregulated in aged animals compared to young adult (p < . ; fold change of | . |). a conservative filter was applied on ipa and only experimentally validated and highly conserved predicted mrna targets for each microrna was used. ipa analysis showed that cardiac hypertrophic signalling is ranked as highly predicted targets for these differentially expressed micrornas (p < . ). moreover, ipa demonstrated that this canonical pathway is upregulated in aged animals when compared to young adult. in addition to cardiac hypertrophic signalling, other relevant cardiovascular canonical pathways, such as endothelin- signalling and intrinsic prothrombin activation pathway have predicted targets. summary/conclusion: our results showed for the first time that micrornas profile in circulating evs has a potential role to drive heart senescence and consequent cardiac diseases which represents the leading cause of death. introduction: introduction: the vascular endothelium and smooth muscle form adjacent cellular layers that comprise part of the vascular wall. here, we examined the extent to which extracellular vesicles (evs) vesicles participate in endothelial-vascular smooth muscle cell communication. methods: methods: evs were collected from rat aortic endothelial and smooth muscle cell serumfree media by ultracentrifugation. vesicle morphology, size and concentration were evaluated by transmission electron microscopy and nanoparticle tracking analysis. endothelial cell and vascular smooth muscle cell cultures were subjected to various concentrations of evs for various times. functional assays were performed. results: results: western blot as well as shot gun proteomic analyses revealed sets of proteins common to both endothelial-and smooth muscle-derived ev as well as proteins unique to each vascular cell type. functionally, endothelial-derived evs stimulated vascular cell adhesion molecule- (vcam- ) expression and enhanced leukocyte adhesion in vascular smooth muscle cells while smooth muscle evs did not elicit similar effects in endothelial cells. evs from endothelial cells also induced protein synthesis and senescenceassociated β galactosidase activity in vascular smooth muscle cells. proteomic analysis of vascular smooth muscle cells following exposure to endothelial cellderived evs revealed upregulation of several proteins including pro-inflammatory molecules, high-mobility group box (hmgb) and hmgb . pharmacological blockade of hmgb and hmgb and sirna depletion of hmgb in smooth muscle cells attenuated nfkb (p ) phosphorylation and nuclear translocation, vcam- expression and leukocyte adhesion induced by endothelial cell evs. summary/conclusion: conclusions: these data suggest that endothelial cell-derived evs can enhance signalling pathways that induce a pro inflammatory in vascular smooth muscle cells. introduction: graft patency is one of the major determinants of long-term outcome following coronary artery bypass graft surgery (cabg). biomarkers, if indicative of the underlying pathophysiological mechanisms, would suggest strategies to limit graft failure. many studies have generated compelling data on the sensitivity of mvs as biomarkers of cardiovascular disease progression and events. the mv usefulness in cabg has been tested only in a study that highlighted their importance in surgical haemostasis. no information is so far available on the association between the amount or pattern of circulating mvs and cabg outcome. we aimed to evaluate whether mv pre-operative signature could predict mid-term graft failure. methods: this was a nested case-control substudy of the coronary bypass grafting: factors related to late events and graft patency (cage) study that enrolled patients undergoing elective cabg. of these, underwent coronary computed tomography angiography months post-surgery showing % graft occlusion. flow cytometry mv analysis was performed in patients ( /group with occluded [cases] and patent [controls] grafts) on plasma samples collected the day before surgery and at follow-up. results: before surgery, cases had two-fold (p = . ) and four-fold (p = . ) more activated platelet-derived and tf+ mvs, respectively than controls. the mv thrombin generation capacity was also significantly greater (p < . ). this mv signature predicted graft occlusion (auc of . [ %ci: , - , ], p = . ). by using a mv-score ( - ), the or for re-occlusion for a score above was . ( % ci . - . , p < . ). summary/conclusion: the pre-operative signature of mvs is an independent predictor of mid-term graft occlusion in cabg patients and a cumulative mvscore stratifies patient's risk. since the mv signature mirrors platelet activation, patients with a high mvscore would benefit from a personalized antiplatelet therapy. exosomes from engineered immortalized human heart cells improve ventricular function and attenuate fibrosis in mice with arrhythmogenic cardiomyopathy yen-nien lin, lizbeth sanchez, rui zhang, thassio ricardo ribeiro mesquita, chang li, ahmed ibrahim, eduardo marbán and eugenio cingolani heart institude, cedars sinai medical center, los angeles, usa introduction: arrhythmogenic cardiomyopathy (ac) is characterized by progressive loss of cardiomyocytes and fibrofatty tissue replacement. currently, there is no effective treatment for this disease. exosomes (imexos) secreted by heart stromal cells, engineered to be immortal and overexpressing β-catenin, exert anti-inflammatory and anti-fibrotic effects and improve ventricular function in models of ischaemic injury (ibrahim et al., nature bme ). methods: to investigate the effectiveness of imexos in a murine model of ac, four-week old homozygous dsg knockout (dsgko) mice and wild type (wt, age-and strain-matched) mice were compared. dsgko mice were randomized to receive weekly imexos or vehicle via intravenous injection for weeks. neonatal rat ventricular myocyte (nrvm) proliferation and apoptotic assays were performed to explore potential effects of exosomes. results: biodistribution studies of dir-labelled imexos revealed some cardiac uptake, along with strong signals in spleen. at weeks, dsgko mice which had received intravenous imexos showed improved cardiac function (echocardiographic ejection fraction ± vs ± % in vehicle mice, p = . ), with an underlying attenuation in myocardial fibrosis by histology. electrophysiology test showed shorter qrs duration ( . ± . ms imexo vs . ± . ms vehicle, p = . ) and effective refractory period. programmed ventricular stimulation showed dsgko mice which had received imexos were remarkably less prone to ventricular tachycardia induction ( . ± % vs . ± % in vehicle, p = . ). in vitro study showed nrvm exposed to imexos for days exhibited higher brdu expression relative to vehicle group, and less annexin-v expression after oxidative stress induced by -minute illumination with nm uv. summary/conclusion: intravenous administration of imexos improved cardiac function, reduced cardiac fibrosis, and suppressed arrhythmogenesis in ac. our findings motivate clinical testing of imexos in ac, an orphan disease with great unmet medical need. funding: nih r hl (to em) cardiac-derived extracellular vesicles contribute to communication between heart and brain in chronic heart failure (chf) and target nrf / are signalling changhai tian a , lie gao b and irving zucker b a department of cellular and integrative physiology, university of nebraska medical center, omaha, usa; b department of cellular and integrative physiology, university of nebraska medical center, omaha, usa introduction: mirnas regulate the translation of proteins that are involved in redox homoeostasis in the heart and brain. intra-and/or inter-organ communication takes place by multiple mechanisms including extracellular vesicular (ev) transport. our previous studies suggested that cardiac derived mirna-enriched evs contribute to the dysregulation of nrf /antioxidant enzyme (are) signalling in the myocardium via intercellular cross-talk, and result in the decreased nrf /are signalling in the sympatho-regulatory areas of the brain in chf. however, it is unclear if cardiac derived evs circulate to the central nervous system evoking sympatho-excitation by disrupting central redox homoeostasis. methods: cardiac-specific membrane gfp+ mice were generated to track the brain distribution of cardiac evs in rats with chf (coronary ligation). the isolation and characterization of evs were carried out by differential ultracentrifugation, tem, nanosight, western blotting, and qrt-pcr. transfection, labelling, and microinjection of evs into the rostral ventrolateral medulla (rvlm) were performed. results: nrf protein was reduced in the rvlm of chf rats consistent with an upregulation of nrf -targeting mirnas. nrf -targeting mirnas were enriched in cardiac and circulating evs of chf rats. nrf -targeting and cardiac-specific mirnas were abundant in brain-derived evs. circulating evs were taken up by neurons in sympatho-regulatory areas of the brain. mirna-enriched evs from chf animals increased sympathetic tone which was prevented by a cocktail of nrf -targeting mirna inhibitors. summary/conclusion: myocardial infarction-induced mirna-enriched evs mediate the inter-organ crosstalk between heart and brain in the oxidative regulation of sympathetic outflow through targeting the nrf / are signalling pathway. these findings suggest that cardiac-derived ev mirnas targeting nrf /are signalling may act as an endocrine signalling mediator of chf that has potential as a novel therapeutic target. introduction: a fine-tuned communication between cardiac cells is vital to maintain myocardial integrity and contractility. not only an impairment of gap junction (gj)-mediated intercellular communication, but also defects in ev-mediated communication have been associated with ischaemic heart disease, a major causative factor of heart failure. we have previously shown that cx , the main ventricular gj protein, assembles into channels at the evs surface, mediating the release of vesicle content into target cells.the main objective of this work was to characterize the signals underlying protein sorting into extracellular vesicles (evs) in a human pathophysiological context, using connexin (cx ) as a model substrate. methods: animal models of ischaemia/reperfusion (i/ r) injury by ligation of the left anterior descending coronary artery, ex vivo and in vitro ischaemia models and human patients were used to investigate the secretion of ev-cx . results: release of cx was downregulated in circulating vesicles from i/r-injured mice and patients with st-segment elevation myocardial infarction, as well as in intracardiac and cardiomyocyte-derived evs. additionally, we show that ubiquitin signalled the release of cx in basal conditions but appeared to be dispensable during ischaemia. depletion of the autophagy adaptor p partially restored the secretion of cx , suggesting an interplay between ischaemiainduced cx degradation and secretion. summary/conclusion: overall, we demonstrated that ischaemia impairs the sorting of cx into evs, which may ultimately affect long-distance communication. through the identification of the underlying molecular mechanisms and players, these results pave the way towards the development of innovative diagnostic and therapeutic strategies for cardiovascular disorders. introduction: remote ischaemic conditioning is a cardioprotective intervention which protects the heart against ischaemia/reperfusion injury. transient activation of toll-like receptor (tlr ) and its downstream regulators (tnfα and il- ) have been implicated in cardioprotective interventions. extracellular vesicles (evs) play a role in cardioprotection through the activation of the tlrs. however, since isolation of evs in high amounts with suitable purity from blood is a challenge, our aim was to develop a cellular model system from which tlr-inducing, cardioprotective evs can be isolated in a reproducible manner. methods: ev release from hek cells was induced by calcium-ionophore a . evs were characterized, cytoprotection by evs against simulated ischaemia/ reperfusion injury and its mechanism were investigated in h c and ac cell lines. results: a induction of hek cell induced ev release and the isolates contained mostly large evs. evs decreased cytotoxicity and apoptosis due to h ischaemia followed by h reperfusion in h c and ac cells in a dose-dependent manner. evs activated tlr and its downstream signalling pathway in h c and ac cells as well as the expression of cytoprotective haem oxigenase (ho- ) in h c cells. summary/conclusion: a -induced evs exert cytoprotection in h c and ac cells by inducing tlr signalling and ho expression. therefore, evs released via calcium-ionophore treatment may serve as a basis of an efficient carpdioprotective therapy. introduction: biliary strictures may be benign or malignant. the major malignant causes of biliary stricture are a primary cholangiocarcinoma (cca) or pancreatic ductal adenocarcinoma (pdac). there is ongoing debate about adequate diagnostics in biliary strictures of unknown aetiology. micrornas (mirnas) are small non-coding rnas important in tumourigenesis. mirna have been found to be enriched in exosomes, small membrane-bound extracellular vesicles (ev) of endocytic origin, which is a novel pathway for intercellular signalling within the tumour microenvironment and have been implicated in loco-regional pre-metastatic niche formation. this project aims to investigate circulating-free and ev mirnas as biomarkers that can aid diagnosis in patients with a biliary stricture. we will ( ) isolate and characterise evs in plasma and bile from patients with benign and malignant biliary strictures (i.e. pancreaticobiliary cancers); and ( ) identify differentially expressed circulating-free and ev mirnas in plasma and bile suitable for detecting malignancy. methods: sample size (n = ) was calculated for a study power of % and α error of % for the ability of extracellular mirnas to discriminate benign from malignant biliary strictures. prospective matched plasma and bile samples will be collected from patients with benign (n = ) and malignant (n = ) biliary strictures undergoing endoscopic retrograde cholangiopancreatography (ercp). evs will be isolated from the biofluids by ultracentrifugation and/or size exclusion chromatography and then characterised (tem, nta and immunoblotting). circulating-free and ev-associated mirnas will be profiled using small rna sequencing. extracellular mirna "signatures" will then be validated by rt-qpcr, and diagnostic accuracy confirmed (sensitivity, specificity, auc). results: evs derived from patient samples have been characterised using nta, western blotting and tem. sec derived evs appear to be more well-defined than uc evs with marker positivity for cd , cd and cd . ongoing work will be focused on rna profiles of evs from both malignant and benign cohorts. summary/conclusion: there is currently no effective method to differentiate benign from malignant biliary strictures. novel plasma and bile circulating-free and ev-associated mirna biomarkers may improve the speed and accuracy of diagnosis, resulting in considerable patient benefits. furthermore, as little is known about the ev-associated function of these tumours, candidate ev-mirnas could be taken from "bedside to bench" and their function further investigated using in vivo, vitro and silico models. introduction: urine is a source of extracellular rna (exrna) biomarkers that can be obtained non-invasively throughout pregnancy. several studies have profiled extracellular mirnas in biofluids during pregnancy, but few have profiled extracellular mrnas (ex-mrnas) in urine. objective: to optimize methods for ex-mrna isolation and rna-seq library preparation from urine of healthy pregnant and non-pregnant females. methods: rna was isolated from pooled non-pregnant urine using kits based on ev precipitation (mircury exosome kit for csf/urine, seramir), ev affinity purification (exorneasy), and protein precipitation (mirneasy serum/plasma advanced). next, long (> nt) and short rnas were isolated from ev enriched urine of pregnant (n = ) and non-pregnant (n = ) individuals using the mircury kit followed by the mirneasy micro kit. rna-seq libraries were prepared using the smart-seq v ultra low input rna (oligo(dt) priming) and the smarter stranded total rna-seq kit v -pico input (random priming) methods (takara). preliminary data were obtained using the illumina miseq, and aligned using star v. . . .a. results: overall, rna isolation using mircury followed by the smart-seq v library preparation kit yielded the highest % of mapped reads: % in pooled non-pregnant, % in individual non-pregnant, and % in individual pregnant urine. for rna extracted using the mircury kit, the smart-seq v libraries had higher % of mapped mrna reads compared to pico libraries (p < . , t-test). in contrast for mirneasy advanced it was reversed ( % vs %). summary/conclusion: early results from low-depth sequencing show the highest mrna mapping rates for mircury followed by the smart-seq v kit. high-depth sequencing data are now being generated, which will enable us to perform detailed comparisons of different rna species from the rna profiles obtained using different library preparations and rna isolation methods from urine of pregnant and non-pregnant subjects. funding: this study was funded by nih k hd - , nih u hl , and a ucsd igm-illumina mini-grant. il- mutein-induced changes of exosomal mirna cargo in a humanized mouse model emily lurier, erik sampson, patrick halvey, mike cianci and katalin kis-toth pandion therapeutics, cambridge, usa introduction: regulatory t cells (tregs) are key contributors to immune homoeostasis. decreased number and/or function of these cells are frequent features of many autoimmune diseases linked to the development of tissue inflammation. while interleukin- (il- ) is essential for pan t cell proliferation and performance, low dose il- treatment has been shown to preferentially affect tregs and is being evaluated as an intervention in autoimmune diseases. pt is a novel il- mutein fc fusion molecule (il- m) designed to selectively engage with tregs. using a humanized nod-scid il rn-null (nsg) mouse model we have shown that pt expanded tregs without significant effects on other immune cells. we have also shown that tregs from pt -dosed humanized mice exhibit increased expression of foxp and cd , and demethylation of foxp and ctla- genes, suggesting enhanced function and stability. in the current study we investigated the mirna content of plasma exosomes isolated from pt -or vehicle-treated mice in order to identify treg specific mirnas from the il- m treated animals. methods: cd + haematopoietic stem cell humanized nsg mice were dosed once subcutaneously with pt or vehicle. plasma samples from mice were collected at day and exosome isolation was conducted using the exoquick method. small rna was extracted and quantified using the bioanalyzer small rna assay. an illumina nextseq instrument was used for library preparation and sequencing with bp single end reads at an approximate depth of - million reads per sample. raw sequences were mapped to human genome grch and analysed via a pipeline provided by the university of california santa cruz. results: rna within the exosomes from vehicle and il- m-treated groups was mostly comprised of mirna and trna. plasma was pooled from animals per treatment group and differential expression was determined using a twofold change cut-off. we found that pt treatment actively altered the mirna content of plasma exosomes, compared to exosomes from vehicle-treated mice. many of the differentially expressed mirnas are involved in immunoregulation. summary/conclusion: plasma exosomes from pt treated humanized mice encapsulated treatment-specific mirnas which can potentially be used as systemic biomarkers of treg expansion and function. identification of potential biomarkers in microglial specific exosomes isolated from prion-infected serum introduction: transmissible spongiform encephalopathies (tse) are neurodegenerative disorders caused by the misfolding of the cellular prion protein (prpc) to the beta-sheet rich abnormal prion protein (prpsc). prpsc aggregates in the brain and causes amyloid plaques, neuronal loss, spongiform degeneration and microglial activation. currently, definitive diagnosis of tse diseases is only confirmed post-mortem thus a diagnostic test in accessible body fluid is of interest. exosomes are a good resource for biomarker discovery since they cross the blood-brain barrier easily and contain protein, lipids and nucleic acids from the cells of origin. the goal of this study was to look at biomarkers from brain-originating exosomes (specifically microglia) isolated in the serum of prion-infected animals. methods: westerns and nanoparticle tracking analysis (nta) were used to look at the composition of microglial-specific exosomes. as proof of principle, exosomes were isolated from a microglial cell line (bv cells). a cd antibody was labelled with a fluorophore and binding to exosomes was visualized via nta. exosomes were isolated from serum of both prioninfected and mock-infected mice throughout disease course. a macrophage specific antibody (f / ) was bound to beads which were used to isolate exosomes which includes those of microglial origin. microrna was extracted from these exosomes and next-generation sequencing (ngs) was performed using the illumina platform. clc genomics workbench was used for bioinformatics analysis. results: microglial and macrophage proteins (tmem and iba ) were identified in exosomes isolated from bv cells and prion-infected mouse serum. macrophage exosomes were isolated via a novel antibody-bead based system. results of the ngs analysis of the microrna isolated from these exosomes indicated a series of mirna that could differentiate between control and infected samples as well as age-specific markers. summary/conclusion: to our knowledge, this is the first time microglial-specific exosomes have been isolated from prion-infected serum from early and end stage disease. the results of this analysis could facilitate the diagnosis of prion disease in easily-accessible biofluids pre-mortem. comparison of urinary extracellular vesicle isolation methods for transcriptomic biomarker research in diabetic kidney disease introduction: urinary extracellular vesicles (uevs) are emerging as a source for early biomarkers of kidney damage, holding the potential to replace the conventional invasive techniques including kidney biopsy. several methods are available for uev isolation. our aim was to compare different workflows and isolation by hydrostatic filtration dialysis (hfd), ultracentrifugation (uc) and a kit based isolation method for their subsequent use in mirna-seq and rna-seq for biomarker discovery in diabetic kidney disease. methods: type diabetic patients (t d) with macroalbuminuria and normoalbuminuric healthy controls were included in the study. sample collection and all experiments were performed in accordance with the declaration of helsinki. evs were isolated from - ml of h urine collections by uc, hfd, or a commercially available kit (purification based on spin column chromatography, urine exosome purification and rna isolation midi kit, norgen biotech, canada) each with different established urine clarification steps. quality control of the evs was performed with negative staining em, nta and western blotting. isolated rnas were profiled with bioanalyzer pico kit and subjected to mirna and mrna sequencing. for rna-seq, cdna library was prepared using smart-seq v ultra low input rna kit for sequencing (takara bio, japan). rna-seq was performed using hiseq (illumina). mirna-seq library was prepared using qiaseq mirna library kit (qiagen, germany). mirna-seq was performed on the illumina hiseq platform (illumina). results: our data showed that uev yield, morphology and size distribution were closely similar in hfd and uc preparations, while lower yields were obtained using the kit. by western blot, ev markers were detectable in samples isolated by hfd and uc but not readily in samples isolated with the kit. tamm-horsfall protein was detected in all the samples and albumin levels appeared higher in hfd and kit isolated samples relative to uc samples. the number of paired-end reads for rna-seq in hfd and uc samples (in both > m) were closely similar. instead, rna reads were lower than m for the kit samples. for mirna-seq, the number of reads as well as the molecular biotype distribution were similar for the three methods. by principal component analysis of the rna-seq data, we observed that hfd and uc grouped together showing similarities. however, for mirna-seq data such similarities were not obvious. this suggests that the three different workflows and isolation principles may enrich different mirna-rich uev preparation components. summary/conclusion: our transcriptomics data shows that hfd and uc are suitable methods to isolate uevs for mirna-seq and rna-seq. the kit based method appears better suited for mirna-seq. introduction: exosomes contain a variety of biomolecules including dna. knowledge of cfdna distribution and localization in bioliquid is important for understanding both biological function of cfdna and exosomes. some publications state that a large proportion of plasma cfdna is localized in exosomes. to quantify cfdna content in free vs. exosomal form in human plasma, urine, and saliva, we employed subx technology, which allows affinity capture dna via phosphates groups of the polynucleotide chain and exosomes via membrane surface phosphate moiety clusters. subx is a proprietary compound that can simultaneously bind to both cfdna and exosomes in bioliquids, thus allowing precipitation of the [subx-dna/ subx-exosomes] complexes without ultracentrifugation. methods: detection of subx-dna and exosomes binding was done by measurement of particle sizes using zetasizer nano zs and nanosight ns . the samples were processed with the subx exo-dna isolation kit following the standard protocols. dna, protein and lipid concentrations were measured by fluorescent assays using qubit fluorometer. results: subx efficiently and selectively captures and co-precipitates cfdna and exosomes directly from bioliquids. exosomes are easily extracted from the pellet in exosome reconstitution buffer (erb), followed by subsequent isolation of tightly bound cfdna from the subx pellet. erb does not extract dna form the [subx -dna] pellet and thus does not contaminate reconstituted exosomes with cfdna. thus, we separate two distinct types of extracellular materialintact exosomes and purified cfdna in a single protocol from the same sample. over % of dna in plasma and urine exist as a free circulating pool, while in saliva up to % is associated with exosomes. thus, cfdna distribution is probably bioliquid-specific and must be evaluated by methods that eliminate cfdna-outer exosomal membrane aggregation. summary/conclusion: subx technology is suitable for simultaneous isolation of both cfdna and exosomes from the same bioliquid sample. subx separates cfdna fragments non-specifically attached to the outer lipid layers of the exosome membrane from the true intra-exosomal cfdna. in contrast, salting-out peg technique is associated with aggregation of macromolecules and vesicles and thus leads to overestimation of exosome-associated polymers content, including cfdna. tracing extrachromosomal dna inheritance patterns in glioblastoma using crispr eunhee yi, amit gujar, hoon kim, albert cheng and roel verhaak jackson laboratory for genomic medicine, farmington, usa introduction: glioblastoma multiforme (gbm) is the most lethal brain tumour; it is characterized by poor response to standard post-resection radiation and cytotoxic therapy, resulting in a dismal prognosis with a five-year survival rate of %. recurrence after therapy for gbm is unavoidable. there are substantial differences among the cells of gbm tumours in the abundance and types of genetic material. this heterogeneity likely is the major cause of therapy failure, the development of treatment resistance, and ultimately recurrence. a recent study has suggested that the amount of a particular type of dnaextrachromosomal dna (ecdna)differs substantially among different gbm tumours, and differs within a given gbm tumour over time. despite the speculation that ecdna is a key factor of tumour heterogeneity, how ecdna is propagated and distributed amongand how it behaves withincancer cells is completely unknown. methods: to address this gap in knowledge, this study focused on developing a novel cytogenetic crisprbased tool that enables visualization and tracking ecdna behaviour in live gbm cells. results: we found breakpoint sequences resulting from genome rearrangements during ecdna formation by performing computational analysis from whole genome sequencing data. and each breakpoint was regarded as a unique target sequence for ecdnaspecific labelling. the uniqueness of each breakpoint was validated by breakpoint-pcr (bp-pcr). furthermore, the location and the amount of each breakpoint were observed by breakpoint-fish (bp-fish) analysis in gbm cells. summary/conclusion: this results will be strong evidence to make ecdna-specific crispr system in further research. tracing ecdna dynamics will provide new insight into the impact of ecdna on cancer evolution. introduction: small extracellular vesicles (sevs) are - nm vesicles that mediate intercellular communication by transferring rna and proteins to the recipient cells. these cargo molecules are selectively sorted into sevs and mirror the physiological state of the donor cells. given that sevs can cross the bloodbrain barrier and their composition can change in neurological disorders, there is an increasing interest in elucidating the molecular signatures of sevs in circulation as disease biomarkers. however, circulating sevs are derived from multiple cellular sources and determining their source is challenging. information on sev composition can be beneficial in predicting whether these sevs are released predominantly from central nervous system cells. we hypothesized that differentially expressed mirnas between neuronal sevs and astrocytic sevs could be used as cell-typespecific signatures. methods: small extracellular vesicles were isolated from cell culture media of postnatal mouse primary neurons and astrocytes using differential centrifugation and characterized using nanoparticle tracking analysis, transmission electron microscopy and western blotting. rna from neurons, astrocytes, and their respective sevs were used for transcriptome and small rna sequencing. results: we observed that only a subset of cellular mirnas was packaged into sevs; differential expression of specific mirnas between sevs and their corresponding cells suggest that cells employ special mechanisms to sort mirnas into sevs. these mechanisms could be celltype specific since neuronal sevs showed a different mirna profile compared to astrocytic sevs. exomotifs, the short sequence motifs that control the loading of rna into sevs, were present in differentially expressed mirnas. we also observed that five rnabinding proteins, which are associated with passive or active rna sorting into sevs, were differentially expressed between neuronal and astrocytic cells. summary/conclusion: mirna signatures of sevs from neurons and astrocytes could be beneficial in determining if these cell types contribute to the alterations of sev composition in circulation in neurological disorders. cell-type-specific selectivity in rna loading might be attributed to the differential expression of rna-binding proteins. introduction: analytes present in the extracellular fraction of bodily fluids (ex. blood, urine) have utility as a tool for uncovering the molecular landscape of tumours and hold great potential for discovery of individualized cancer medicine. urine, being noninvasive as a sample type, has an obvious advantage over blood when used for liquid biopsy purposes. however, potential for microbial proliferation and the labile nature of host cells and extracellular vesicles (evs) at the point of sample collection/transport to the lab drives the need for stabilization of urine samples. development of such sample stabilization opens up capability for the detection of various biomarkers present in the extracellular fraction to be used in liquid biopsy. this is of particular concern as studies around urinary analytes for cancer diagnosis, progression and therapeutic effect are rapidly expanding in cohort sizes. multi-site collections and at-clinic collections are increasingly prohibitive for large scale recruitment and also lead to variability in the time between collection and processing. methods: in this study, we have analysed two commercially available ev extraction kits and compared them with ultracentrifugation technique for size, concentration and specificity of the isolated evs from human urine samples with and without our proprietary preservation solution using nanoparticle tracking analysis and western blot analysis for exosomal membrane markers. ev rna contents in various urine fractions (first morning first void, random first void and midstream) were compared using rt-qpcr assay to provide better understanding of the collection techniques and fractionations that are ideal for ev research work. results: in our current work, we have bench-marked human urine collection and ev extraction in order to provide recommendations in standardization of sample acquisition and processing for urinary ev studies. we have utilized these standardization in order to develop a novel and efficient sample stabilization principle for preservation of evs and ev rna in urine samples during an ambient temperature hold. summary/conclusion: taken together, we have established a framework for evaluating technologies and techniques in the ev sample processing space, which can be utilized by other research groups. vn -isolated plasma extracellular vesicles improve tumour mutation detection by next-generation sequencing compared to cell-free dna and correlate with tissue biopsy of nsclc patients introduction: liquid biopsy is a minimally-invasive diagnostic method that detects circulating biomarkers and has the potential to improve access to molecular profiling for nsclc patients when tissue biopsy material is unavailable or insufficient. although isolation of cell-free dna (cfdna) from plasma is the standard liquid biopsy method for detecting dna mutations in cancer patients, the sensitivity can be highly variable. vn is a amino acid peptide with an affinity for heat shock proteins that are exposed on the surface of extracellular vesicles (evs); peptide-ev aggregates readily sediment using a benchtop centrifuge and therefore the vn peptide provides a rapid, clinically-amenable procedure for ev isolation. in this study, we determine whether isolation of evs from nsclc patient plasma improves the sensitivity of single nucleotide variants (snvs) detection compared to cfdna and correlate genetic changes observed by liquid biopsy with tumour ffpe tissue biopsy. methods: blood was collected from stage iii/iv nsclc patients with informed consent in either edta or cell-free dna bct® collection tubes and plasma was harvested within minutes. total nucleic acid (tna) was extracted from either vn -isolated evs from edta plasma or directly from plasma collected in edta or cell-free dna bct® tubes (cfdna). snvs were detected by next-generation sequencing (ngs) results: vn isolation of evs from plasma resulted in higher recovery of dna than cfdna isolation. the snvs detected in both ev-dna and cfdna correlated well with those reported in matched ffpe tumour tissue using ngs, including % specificity for egfr mutations. no improvement in snv detection was observed using cell-free dna bct® collection tubes compared to edta tubes. isolation of evs with the vn peptide prior to sequencing improved a number of ngs parameters including library yield, total reads, median read coverage and molecular coverage, resulting in improved sensitivity of snv detection. summary/conclusion: in summary, our research demonstrates that vn -based ev isolation is useful for molecular profiling of nsclc patients for whom tissue biopsy is not an option, thereby improving access to molecular profiling and targeted therapies. funding: atlantic canada opportunities agency novel markers for neuroendocrine prostate cancer divya bhagirath a , michael liston b , theresa akoto a and sharanjot saini a a augusta university, augusta, usa; b veteran affairs, san francisco, usa introduction: prostate cancer (pca) is fuelled by androgens and androgen receptor (ar) signalling. therefore, ablation of ar signalling by androgen deprivation therapy (adt) is the goal of first-line therapy that results in cancer regression initially. however, two to three years post-adt, the disease develops into castration-resistant prostate cancer (crpc). as a second-line of therapy, next generation of ar pathway inhibitors (api) such as enzalutamide (enz) are used that are effective initially followed by emergence of drug resistance. a subset of api-resistant tumours emerges to an ar independent state via undergoing a trans-differentiation to neuroendocrine lineage, a process referred to as neuroendocrine differentiation (ned). due to lack of ar signalling, these pca variants, referred to as neuroendocrine prostate cancer (nepc), are impervious to anti-androgen therapy and constitute an aggressive variant of advanced crpc with poor prognosis. currently, there is a lack of effective molecular biomarkers for predicting api therapy resistance and emergence of therapy-induced ned. methods: exosomes/evs were isolated from sera of a patient cohort with/without ned. the study was conducted in accordance with ethical guidelines of us common rule and was approved by the institutional committee on human research. written informed consent was obtained from all patients. following extensive characterization of evs by electron microscopy, nanosight tracking analyses and western blotting of exosomal markers, small rna sequencing was carried out on illumina hiseq platform to identify differentially expressed transcripts. machine learning algorithms were applied to clinical sequencing data to train a "mirna classifier". further, we probed the proteomic profile of exosomes isolated from nepc cellular model nci-h and enzalutamide resistant crpc cell lines by mass spectrometry. results: we identified that transition from crpc-adenocarcinomas to neuroendocrine states is associated with significant ev-mirna dysregulation, with a specific dysregulation in certain mirna families. with the application of machine learning algorithm, we identified an ev-based "molecular classifier" that can robustly stratify crpc-ne tumours from crpc-adenocarcinomas. proteomic analyses identified novel nepc-specific, glycosylated proteins that can be exploited for nepc diagnosis. summary/conclusion: our data suggest that ev mirna and protein profile can predict neuroendocrine differentiation in advanced castration-resistant prostate cancer patients. exosomal mrna in diagnosis strategy for hepatocellular carcinoma aleksandr abramov, alisa petkevich, vadim pospelov and pavel ogurtsov peoples' friendship university of russia (rudn university), moscow, russia introduction: exosomal cargo is informative source illustrating the genetic events happening in cells, what can be especially advantageous in case of cancer development for disease progression or treatment effectiveness monitoring. methods: plasma samples of hepatocellular carcinoma (hcc) patients, plasma samples of patients with liver cirrhosis - on the hepatitis c virus (hcv) background, healthy donors' plasma samples. exosomes were isolated with ultracentrifugation, western blot (cd , cd ) was performed. total mrna was isolated with exosomal rna isolation kit, norgen biotec corp. sequencing was carried out on a minion sequencer. housekeeping genes (gapdh, b m, actb, tuba a). detected mutations were confirmed by real-time pcr with specific highly sensitive lna probes. results: significant changes in expression levels were identified for genes in hcc and liver cirrhosis groups (increasing up to x compared to control samples and decreasing up to no detected expression). in out of patients with hcc mutant burden was significant increased compared to mutant burden in groups with cirrhotic samples. in out of patients with hcc increased expression for mrna line- was identified compared to cirrhotic patients. summary/conclusion: exosomal mrna expression levels may serve as a prognostic and diagnostic marker for patients with liver cirrhosis caused by hcv for hcc risk development. funding: research is supported with federal funds " - " circulating extracellular vesicle signatures in small cell lung cancer michela saviana a , giulia romano a , giovanni nigita b , robin toft a , patricia le a , kai wang c , mario acunzo a and patrick nana-sinkam a a virginia commonwealth university, richmond, usa; b the ohio state university, columbus, usa; c institute for systems biology, seattle, usa introduction: lung cancer is the leading cause of cancer deaths worldwide and classified primarily as either non-small cell lung cancer (nsclc) or small cell lung cancer (sclc). compared to nsclc, sclc has a faster growth rate, earlier widespread metastasis, and shorter overall survival. the early diagnosis of sclc and the development of novel therapeutics have proven challenging. thus, progression and recurrence rates remain high. non-invasive methods for cancer detection are increasingly being used to inform clinical decision making. extracellular vesicles (evs) have recently emerged as potential carriers of genetic contents such as micrornas (mirs) to induce reprogramming of components of the microenvironment in cancer initiation and progression. moreover, extracellular mirs expression profiles have been shown to have signatures related to tumour classification, diagnosis, and progression. methods: we selected a cohort of patients divided into groups: high-risk smokers, adenocarcinomas, squamous carcinomas, and sclc. we extracted total circulating ev and plasma rna from plasma ( patients in total) and rna from plasma in a separate group ( patients in total). utilizing both next-generation sequencing (ngs) and nanostring platforms, we analysed for global microrna (mirs) expression patterns. candidate mirs were then validated by qrt-pcr. results: we identified several deregulated mirs in both evs and plasma of sclc patients compared to the other groups. for evs, we validated mir- - p as a significant biomarker for the late stage of sclc compared to controls. in the case of plasma, we validated the upregulation of mir- in sclc compared to controls. summary/conclusion: our results indicate that a potential combination of plasma (mir- ) and ev-based (mir- - p) mirs be valuable biomarkers for sclc detection and serve as a basis for a non-invasive sclc classifier. funding: virginia commonwealth university, doim -nih/nci introduction: the isolation of evs from milk is technically challenging due to the complexity of milk. currently used separation procedures allow for the removal of milk fat globules and cells (by low speed centrifugation of fresh milk), removal (by acidification), or disruption (by addition of edta) of casein micelles. using these protocols the integrity, composition and targeting of bovine milk evs has been evaluated and has led to believe that milk evs might withstand these conditions. however, the effects on functionality of milk evs (i.e. immunomodulatory properties) after processing and isolation have not been studied. therefore, we have set up an in vitro culture system using a human t cell line that allows for the rapid screening of milk ev functionality. methods: fresh bovine milk was defatted and cells were removed after x , g centrifugation, followed by differential centrifugation at , g and , g. this milk was either subjected to acidification with hcl, or edta was added, or the milk supernatant remained untouched. top down optiprep density gradient separation followed by sec was used to further purify evs. these highly purified milk evs were added to human jurkat t cells, which were simultaneously stimulated using anti-cd and anti-cd antibodies. after h t cell activation was measured by il- cytokine production. results: precipitation or disruption of casein micelles allowed for the substantial removal of proteins during isolation compared to directly isolated evs, which aids in the purification of milk evs. in vitro analysis revealed that in the presence of directly isolated, or edta isolated milk evs, jurkat cells were suppressed in their activation as measured by il- production. remarkably, evs isolated from hcl-acidified milk were impaired in their suppressive capacity to inhibit il- production. summary/conclusion: although casein removal from bovine milk greatly improves purity of isolated milk evs, the detrimental effects on ev functionality should be considered. interestingly, evs exposed to acidic conditions lost their ability to modulate t cell activation, which is in contrast with the general believe that milk evs could withstand the gastro-intestinal tract. funding: this work is funded by the european union's horizon framework programme under the grant fetopen- evfoundry. optimising methods for separation and characterisation of extracellular vesicles from skim milk and infant milk formula introduction: infant milk formula (imf) is intended to impart nutrition to infants, similar to breast milk. however, although industrial imf production involves harsh treatment, potential consequences on extracellular vesicles (ev) in imf are not yet established. this study aimed to optimise methods for separating evs from imf and skim milk (sm) and to characterise the evs in accordance with misev . methods: sm and imf were either not treated (nt) or treated with acetic (aa) or hcl acid (isoelectric precipitation, ip), to remove caseins. samples were then subjected to differential ultracentrifugation (duc) or gradient ultracentrifugation using iodixanol solution (guc). for duc, ml samples were centrifuged at k g, k g, k g, k g and k g sequentially for min each and pellets re-suspended in ml pbs. preparation of agarose microspheres for high-efficient separation of extracellular vesicles cheng-tai chen, chien-an chen, carolyn yen and nien-tzu chou industrial technology research institute, chutung, taiwan (republic of china) introduction: size exclusion chromatography (sec) is becoming a widely used technique for separating of extracellular vesicles. various commercially available products were launched on the market, however, their separation efficiencies were not fully disclosed. herein, novel porous agarose microspheres with the tunable diameter and pore size were synthesized by emulsion reaction. the performance was evaluated and compared with commercial products. the modified sec column packing materials were shown to exhibit advantages for rapid, high-recovery and high-purity separation of extracellular vesicles from cell culture-conditioned medium and human plasma. methods: the homemade sec column was packed by gravity flow. μl of the sample was loaded and the pbs buffer was used as eluent. factions were collected and analysed by cd /cd sandwich elisa assay and by micro bca assay for determining respectively extracellular vesicles and total protein content. results: agarose microspheres were prepared by emulsification. the particle size can be controlled by the types and concentrations of surfactants. the product was collected by desired screen meshes and used as packing materials of the sec column. our results showed that the extracellular vesicles were clearly separated from proteins. more than . % of proteins were removed while the recovery of extracellular vesicles was close to %, which is much higher than % of the commercial product. the total separation time was less than min. summary/conclusion: we have established an approach for generating spherical agarose microspheres as packing materials of homemade sec columns, which are capable of separating extracellular vesicles from complex samples with high efficiency. further validations with additional samples are currently ongoing. immunomagnetic sequential ultrafiltration (isuf) platform for enrichment and purification of extracellular vesicles from large and small volumes of biofluid eduardo reategui, jingjing zhang, luong t. h. nguyen, richard hickey, nicole walters and andre f. palmer the ohio state university, columbus, usa introduction: evs derived from tumour cells have the potential to provide a much-needed source of non-invasive molecular biomarkers for liquid biopsies. however, compromises have to be made when using a particular technology/methodology for the isolation of evs. currently, there is a trade-off between sample volume and specificity in ev isolation technologies that limits quantitative molecular analysis of ev contents, ultimately impacting the utility of evs in cancer diagnostics. here, we present an approach called immunomagnetic sequential ultrafiltration (isuf). our platform combines ultrafiltration and immunoaffinity separation. using isuf, we demonstrate that small or large volumes of biofluid can be processed (~ µl or > ml) while concomitantly removing . % contaminating proteins. we also processed serum from breast cancer patients enabling the characterization of different tumour and immune biomarkers on the isolated evs. methods: human samples were collected under an approved irb. size distribution and concentration of evs were measured using a tunable resistive pulse sensing (trps) method. ev proteins and rnas were extracted and quantified using a bca protein assay and uv spectroscopy. isuf and other ev isolation methods were compared for ev concentration, protein, and rna quantity. results: ml of cell culture media (ccm), . ml serum, and ml urine samples were processed with the isuf platform and recovered in µl. for all cases, evs were enriched with recovery efficiency greater than %. the processing time for a ml sample was min with over % of purity. we compared ev concentration and purity isolate from . ml serum using isuf and other commercially available methods, isuf demonstrated superior performance on isolating evs at high concentrations and purities. analysis of total rna amounts in the isolated evs using different methods was corresponding to higher ev recovery efficiency of isuf. we also compared protein and rna levels of evs enriched with isuf present in urine and serum samples from the same donors (n = ), and we found that for the same number of evs, the ev rna concentration from both biofluids showed no significant difference. finally, we have processed serum samples from metastatic breast cancer patients and demonstrated that their isolated evs have expression levels of her , cd and mir biomarkers at significantly higher levels than healthy controls. summary/conclusion: the isuf platform can be scale-down or -up to work with small or large volumes of biofluids for the isolation of evs. using the isuf platform with clinical samples shows the potential of our platform to be used for cancer diagnosis or monitoring treatment response. funding: national institutes of health (nih) grants ug tr (e.r.); r hl , r hl , and r eb (afp). challenges in exosomes isolation from primary biological samples derived from multiple myeloma patients introduction: multiple myeloma (mm) remains incurable despite advances in its treatment and research progress on the crosstalk between mm and surrounding host cells. exosomes are important regulators of the cellular niche. their importance for diagnostic and therapeutic applications has been proven in many cancers. in this context we hypothesized that a better understanding of the molecular role and features of mm-derived exosomes would provide a basis for their use for both risk stratification and as predictive biomarkers of response to anti-mm drugs already in use in clinical settings, given the optimization and validity of their isolation/purification method. methods: exosomes were isolated from human mm cell lines (hmcls) supernatants and peripheral blood plasma (pbpl) isolated from healthy donors, mm and mgus (monoclonal gammopathy of undetermined significance) patients. both fresh and frozen samples were tested. we evaluated commercially-available kits, density-based separation and ultracentrifugation. results: higher purity and recovery, evaluated by western blotting, nanoparticle tracking analysis and electron microscopy, were observed for supernatant density-based purification and for pbpl resin-based isolation. exploring the function of mm-derived exosomes, we observed an increase in proliferation of the immortalized stromal cell (sc) line hs treated with exosomes when compared to untreated cells, and a higher increase in proliferation of scs treated with mm-exosomes when compared to exosomes derived from normal and mgus pbpl samples. summary/conclusion: the method of isolation represents a critical step in the study of exosomes as many factors can affect the purity, yield and downstream application. our data demonstrated that density and resin-based isolation methods provided functional mm-derived exosomes with proliferative effects on scs. altogether our findings may serve as a guide to choose exosome isolation methods for mm studies. further optimization steps, including albumin-depletion from plasma samples and use/type of serum in cell cultures, should be taken into consideration when planning proteomics and genomics as downstream applications. funding: australian government rtp and monash departmental scholarship. a rigorous method for exosome isolation from post-mortem eyes introduction: in order to determine and validate the tissue-specific content of extracellular vesicles (evs) in biofluids, robust ev isolation methods from tissues must be developed. however, to date very few rigorous methods to isolate or enrich for intact evs from tissues have been reported. we present a comprehensive exosome isolation method with a sufficient level of characterization to unequivocally demonstrate true ev identity from ex vivo eyes. methods: iodixanol (optiprep) buoyant density gradient ultracentrifugation (dguc), cushioned dguc (c-dguc), and our newly developed c-dguc immunocapture (c-dguc-ip) method were used to compare yield and enrichment of exosomes isolated from porcine eyes between to hours post-mortem. yield was assessed by nanoparticle tracking analysis (nta) and immunoblotting for exosomal markers along with total protein quantitation. enrichment was assessed by comparison of exosomal markers, ocular-specific markers and known contaminant markers, plus in-depth proteomic mass spectrometry analyses. results: high enrichment of posterior eyecup small evs (sev) were achieved by dguc and c-dguc, with c-dguc resulting in an eightfold increase in yield by nta and two to fivefold increases of exosomal protein markers such as syntenin- and cd by immuno-blotting compared to dguc. interestingly, in-depth proteomic analyses revealed that a majority of these sevs with densities of . - . g/ml isolated by dguc and c-dguc were likely of endoplasmic reticulum (er) and golgi origin, suggesting er-to-golgi transport vesicles resulting from post-mortem tissue cell rupture. in order to enrich further for sevs (including exosomes) we subjected sevs isolated by c-dguc to anti-cd immunocapture. the resulting sev proteome was enriched . -to -fold for bona fide sev and exosome markers compared to c-dguc. summary/conclusion: the c-dguc method provides an enhanced yield and purity of sevs and exosomes from ex vivo eye tissue. however, to avoid significant contamination with er and golgi-derived vesicles from postmortem eyes, a final ev-specific immunocapture step is required to achieve sufficient purity for subsequent analyses. our highly rigorous method paves the way for identification and validation of ocular-derived exosomes in blood and their potential use as eye disease biomarkers. characterization of the extraction of extracellular vesicles using a lab-ona-disc filtration system introduction: personalized treatment for cancer is a promising way to face the multiplicity of the disease, to increase the efficacy of drugs and to decrease their toxicity. as part of this strategy, liquid biopsy explores a new non-invasive approach to diagnose cancer, guide treatment and monitor its efficacy. extracellular vesicles (evs) are nanometric lipid bilayers micelles with high potential as biomarkers. they are involved in the transfer of information (proteins, rna and dna) between cells. evs include a broad spectrum of particle sizes, from the tens to thousands of nanometres. the isolation of evs from complex matrices is the first step of any protocol and is particularly important for the reproducibility and fidelity of the results presented, as it could bring bias in further analysis. in order to explore the heterogeneity of evs, a full characterization (physical and biological) of the extracted evs is needed. we evaluate and compare evs purification methods, including ultracentrifugation, sizeexclusion chromatography (sec) column and an emerging microfluidic technology: labspinner filtration labon-a-disc device isolating evs between two filters of and nm. methods: a cell supernatant was used as a model matrix. we compared three methods of extraction of evs: ultracentrifugation with two cycles of h at , g at degrees celsius (rotor type ti, beckman floor ultracentrifuge optima l k), qev size exclusion chromatography columns from izon (qevoriginal/ nm) and lab-on-a-disc filtration system (labspinner, exodisc c). evs characterization was conducted with nta (nanosightns ), trps (izon), nanodrop (spectrometernd ), tem (fei tecnai kv) and custom micro-immuno-assay. results: in this study, we characterize a filtration system made of two serial filters of nm and nm pores for isolation of evs. compared to ultracentrifugation and chromatography columns, yield of extraction is up to times higher and the size of the extracted particles is smaller. tem imaging was used for assessment of the quality of the extracted evs. however, albumin concentration measurement tends to show that the purity of the solution is decreased. the immuno-labelling analysis shows that the proteomic signature of the extracted evs differs according to the extraction methods. the new filtration technology seems to give us access to a broader range of evs compared to standard methods. summary/conclusion: in this study, we characterized purification methods including lab-on-a-disc filtration, and were able to demonstrate an increase of the concentration of evs by a factor of , a decrease of the size of the accessible extracted particles and access to new proteomic signatures. funding: we acknowledge the support of génome québec and action marie skłodowska-curie. effects of sample processing on isolation of extracellular vesicles from blood plasma by centrifugation darja božič a , matej hočevar b , veno kononenko c , marko jeran a , urška Štibler d , immacolata fiume e , manca pajnič f , ljubiša pađen f , ksenija kogej g , damjana drobne c , ales iglič h , gabriella pocsfalvi i , veronika kralj-iglič f and darja bozic j introduction: the isolation of extracellular vesicles (ev) from body fluids is still controversial and the poor understanding of vesicle stability and effects of sample processing is probably one of the core issues preventing the breakthrough of this field into applicative practices. methods: we performed an in-depth study of sample changes in blood, blood plasma and samples throughout the increasing speed of centrifugation, considering the number, size, contents and shape of particles in the isolates. flow cytometry, light scattering, mass spectrometry and scanning electron microscopy were employed to reveal the properties of material in the samples. results: the particles of size about - nm with characteristic topology of membrane vesicles without internal structure were observed by the scanning electron microscope only in ev isolates prepared from fresh blood sample. inspection of the tube surface in which the isolation took place suggests that those particles are likely formed from activated platelets tearing at the tube wall due to the centrifugal pull. the isolates prepared from frozen blood plasma prepared by centrifugation with different forces contained different amounts of particles with similar protein contents, predominated by highly abundant human plasma proteins, including albumins and immunoglobulins. some lipoprotein clearance and fibronectin precipitation were however observed through increased speed and time of centrifugation. summary/conclusion: the results of this study [ ] contribute to the understanding of stability and dynamics of membrane particles. the reported evidence provides the support for viewing ev isolates as a product, shaped by uniqueness of the starting samples and the thermal and mechanical stress applied upon processing. we believe this kind of insights strengthen our ability of reading the story of evs. introduction: apoptosis is a form of programmed cell death with diverse roles in the tumour microenvironment and emerging data show that, besides its role in tumour suppression, it can also promote oncogenic proliferation. highly aggressive tumours such as burkitt lymphoma (bl) show high levels of apoptosis, which has a diagnostic and prognostic value for classifying and staging the disease. we hypothesize that amongst other elements, extracellular vesicles (ev) are key mediators of apoptotic cell-derived tumour microenvironment signals. here, we report on ev released in vitro by apoptotic bl cells (apo-ev) in relation to their potential use as cancer biomarkers. methods: basic physical properties of apo-ev such as structure, size distribution, surface charge and membrane fluidity are discussed using cryo electron microscopy (em) and tomography, nanoparticle tracking analysis, dynamic light scattering and fluorescence anisotropy respectively. for phenotypic analysis we apply immunocapture and flow cytometry, immunogold labelling on transmission em, fluorescence microscopy and quantitative pcr. in addition, we study the interaction of apo-ev with blood components such as platelets, leucocytes and red cells, in order to understand their effects in the circulation and therefore their potential for analysis in blood samples. results: looking at the differences between apo-and non-apo-ev, apo-ev have larger diameter, while structurally are not different. however, we have identified distinct apo-ev markers such as active caspase and histones, or dna and small non-coding rna-y. there is also strong interaction of ev with platelets and leucocytes but not with red cells, indicating potential routes of transfer of ev cargo in the circulation. summary/conclusion: it is concluded that for the characterization of the heterogenous ev populations, combination of multiple techniques is often required, and also, understanding the strengths and limitations of each method is essential for choosing the appropriate set of analytical tools. finally, we consider that monitoring free circulating apo-ev or blood cells with which they have interacted is a promising approach to improve cancer diagnosis, prognosis and evaluation of therapeutic response. casting a small netrin: functional roles of a novel surface factor on stroma-derived extracellular vesicles in pancreatic cancer kristopher s. raghavan a , ralph francescone b , janusz franco-barraza b and edna cuckierman b a drexel university; fox chase cancer center, philadelphia, usa; b fox chase cancer center, philadelphia, usa introduction: pancreatic ductal adenocarcinoma (pdac) is a devastating disease driven and supported by changes in its microenvironment, or stroma. here we dissect the intercellular communication that exists between the primary stromal component, cancer-associated fibroblasts (cafs) and pdac. pdac communicates with its microenvironment, in part, through the exchange of specific types of extracellular vesicles (evs). specifically, we focus on the mechanism by which caf-secreted evs support pdac survival, with an additional goal to identify biomarkers suitable to generate a future "liquid biopsy" test for early pdac detection and prognosis. methods: evs are isolated from patient-derived pdac-associated fibroblasts via differential ultracentrifugation and validated by isev standards. human pdac cell lines used as recipient cells are treated with caf-evs to assess their role in supporting pdac survival. recombinant proteins, neutralizing peptides, and non-functional mutant proteins are used to block ev interaction with target cells. results: we observe sub-types of caf-evs containing unique surface receptors. one ev sub-population of interest contains a novel surface protein (nsp) expressed on the plasma membrane of pancreatic cafs, but not their healthy counterparts. further, pdac cells up-regulate nsp's lone binding partner, suggesting a role for these factors in pdac-selective ev uptake. functional assays designed to test pdac viability suggest these nsp(+)-evs protect pdac cells from programmed cell death as a result of physiological stress. this ev-mediated survival benefit can also be inhibited by blocking the interaction of nsp and its binding partner, suggesting the engagement of these two factors is necessary for cafs to support pdac via evs. pursuing our biomarker goal we confirm stromal nsp expression increases during early panin stages prior to tumour development, and we are currently seeking to validate nsp(+)-evs in blood of pdac patients. summary/conclusion: this research shines light on a novel mechanism of tumour-stroma communication that may be crucial for cancer progression during early disease stages and a potential target for disrupting the supportive role of the tumour microenvironment. additionally, we describe a sub-population of nsp (+)-evs that have the potential to serve as biomarkers for identifying pdac development. exosomes carry distinct mirnas that drive medulloblastoma progression introduction: extracellular vesicles (evs) represent an ideal source of functional biomarkers due to their role in intercellular communication and their ability to protect cargo, including rna, from degradation. the most investigated ev's are exosomes, nanovesicles secreted by all cell types and able to cross the bloodbrain-barrier. here we characterised the rna of exosomes isolated from medulloblastoma cell lines, with the aim of investigating exosomal rna cargo as potential functional biomarkers for medulloblastoma. methods: exosomes derived from a panel of matched (original tumour and metastasis) medulloblastoma cell lines were isolated and characterised by nanosight, electron microscopy, western blotting and nanoscale flow cytometry. exosomal mirna and mrna from our matched cell lines and foetal neuronal stem cells, which were used as a normal control, were analysed by rna-sequencing technology. results: based on hierarchical clustering, malignant derived exosomes were distinctly separated from normal control exosomes. mirna profiling revealed several established oncomirs identified in our malignant derived exosomes compared to control samples. using interaction pathway analysis, we identified that our malignant exosomes carry numerous mirnas implicated in migration, proliferation, cellular adhesion and tumour growth. several previously identified oncomirs were also identified to be present at higher levels in metastatic exosomes compared to primary and normal, including hsa-mir- - p and hsa-mir- a- p. summary/conclusion: this study shows that exosomes from mb cells carry a distinct mirna cargo which could enhance medulloblastoma progression. the use of circulating exosomes as markers of metastatic disease could be an innovative and powerful noninvasive tool. introduction: inflammatory changes in the bone marrow (bm) and suppression of haematopoietic stem and progenitor cell (hspc) function during acute myeloid leukaemia (aml) significantly contribute to patient morbidity and mortality. our laboratory has previously shown that aml-derived extracellular vesicle (ev-aml) trafficking confers a state of enforced quiescence and leads to lasting dna damage in hspcs. here we explore the underlying cause. specifically, we hypothesize that ev-aml incite inflammatory regulators as potential mediators of dna damage. methods: as a validated model of aml, we utilized the murine tib cell line as a source of ev-aml. ev-previous work has indicated that mirnas, notably mir- a and mir- , play a critical role in scc tumour development. evs are membrane-bound vesicles involved in cell-cell communication carrying actively sorted cargo, protected from degradation. the potential pathways these vesicular mirnas modulate and the implication they have on cancer biology is under active investigation. we have previously shown that the cadherin dsg , a stem cell marker, modulates ev release. dsg is upregulated in a number of cancers, including scc, and correlates with poor prognosis. here we aim to elucidate the impact of ev-associated mirnas in sccs by bioinformatic analysis. methods: scc cells stably expressing dsg were generated and evs isolated by sequential ultracentrifugation. total cellular and ev rna was isolated by mirneasy, analysed using rnaseq and identified by grch alignment. results were confirmed by qpcr. altered pathways based on targets were identified using mirnet and kegg pathway analysis. potential cancerassociated cytokine targets were confirmed by antibody array. results: rnaseq revealed cellular and ev mirnas that were differentially expressed in response to dsg with overlapping. the highest altered mirnas were validated by qpcr. kegg pathway analysis determined that these mirnas have the highest number of shared targets in cancer, cell cycle, and p signalling pathways. interestingly, mir- was upregulated while mir- a was dramatically downregulated in evs. targets of mir- a, icam- , il- , and il- , cytokines critical for cancer progression were upregulated. summary/conclusion: these results suggest that the mirna content of evs is tightly regulated. by altering the mirna profile, dsg contributes to the pathogenicity of these evs by increasing levels of cytokines important for cancer stem cell renewal and metastasis. in addition, these mirnas may serve as non-invasive diagnostic markers for sccs. funding: nih r cancer cells grown in d release distinct extracellular vesicles during tumour growth and invasion jens c. luoto, sara bengs, leila coelho rato, lea sistonen and eva henriksson Åbo akademi university, turku, finland introduction: cancer cells secrete extracellular vesicles (evs) that affect tumour progression. the characteristics of evs produced during tumour growth and invasion are however poorly understood. in this study, we identify the composition and characteristics of evs produced by noninvasive and invasive tumours and correlate these characteristics with the invasive status of the tumour. for that purpose, we established a protocol for isolating evs from extracellular matrix (ecm)-based three-dimensional ( d) cancer cell cultures. methods: human prostate cancer pc cells were grown in d cultures using ecm-based hydrogel, in standard d culture conditions and in bioreactor. evs were isolated from these cultures with differential and density gradient centrifugation. the isolated evs were characterized with nanoparticle tracking analyses, electron microscopy, immunoblotting and mass spectrometry (ms). results: our results demonstrate that d ecm-based hydrogel cell cultures secrete evs that can be isolated from both the conditioned media and the hydrogel. the invasive d cultivated pc organoids were found to secrete large amounts of evs compared to the non-invasive organoids. interestingly, our ms results revealed that non-invasive and invasive organoids secrete evs with partially distinct protein cargo. summary/conclusion: we have established a novel protocol for ev production in a d cell culture system utilizing ecm-based hydrogel, in which invasive tumour growth can be mimicked. our method allows the specific isolation and characterization of evs derived from different stages of d culture, such as non-invasive and invasive organoids. importantly, we found that tumour-derived evs change in composition during the tumour progression. taken together, our method can be used to define the distinct ev characteristics involved in cancer invasion. we previously showed extracellular vesicles (evs) to be causally involved in transmitting drug resistance. this study aimed to evaluate compounds proposed to reduce/block ev release. specifically, we selected calpeptin and y (proposed to inhibit evs budding from the cell membrane) and manumycin a and gw (proposed to inhibit evs deriving from mvbs). associated effects on -and consequences of-ev release were then investigated. methods: suitable compounds concentrations that were non-toxic to cells were first selected by performing cytotoxicity assay and flow cytometry (fc). conditioned medium (cm) was collected from docetaxel-resistant pc (pc rd) cells after h incubation in dfbs-medium with or without the compounds. evs were separated from tangential flow filtration concentrated cm using optiprep density gradient. . - . g/ml fractions were then pooled and washed. evs were characterised using nta, immunoblot, tem and lipid assay and fc. influences on growth and migration, of evs continuing to be released (at x evs/ x cells, x evs/ x cells), were evaluated on recipient du and rv cells. evtrack id ev , score % results: calpeptin and y , alone and in combination, did not significantly affect quantities of evs released. however, gw significantly (p < . ) increased quantities of released evs, of a larger size; very high protein to lipid ratio; and carrying grp compared to control evs (p < . ). this effect was reverted when gw was combined with manumycin a (p < . ). following all compounds treatments, x evs/ x cells inhibited rv proliferation (p < . ), while at x evs/ x cells only evs from manumycin a (p < . ) and y (p < . ) treated cells reduce rv proliferation. evs following gw treatment significantly (p < . ) inhibited du migration compared to bulk non-treated control and compared to the effect obtained using the entire pool of evs (p < . ). summary/conclusion: while none of the proposed inhibitors significantly reduced ev release, the resulting evs were less potent in transmitting aggressive behaviour, such as proliferation and migration, to receiving cell lines. patient-derived organoids represent a novel tool to study the effect of intra-tumoral heterogeneity on ev release in non-small cell lung cancer introduction: lung adenocarcinoma (luad) is the leading cause of cancer-related death with a low -year survival. although the importance of intra-tumoral cellular heterogeneity of solid tumors in the clinical outcome and treatment is emerging, proper models to study its effects on ev release and cargo in human tissues still lack. the d organoid technology maintains the cellular and genetic heterogeneity of in vivo tissues and has proved to be so far the best ex vivo model of human cancers. by using patient-derived and mouse organoids we set out i) to compare the ev release from normal and tumor tissues and ii) to follow changes in ev secretion when the relative ratio of tumor cell subpopulations is shifted. methods: we used mouse and luad patient-derived normal and tumor organoids. the medical research council of hungary approved our experiments with human samples and informed consent was obtained from patients. evs were detected by antibody-coated beads, nta and tem. intra-organoid heterogeneity was proved by immunostaining and rt-qpcr. results: we provide evidence that both mouse and human normal organoids contain all the bronchiolar cell types. interestingly, luad organoids selected for tp mutation contained not only ki + proliferating cells, but differentiated cell types as well. furthermore, all the lung organoid cultures produced evs and this was shifted to the smaller size range. interestingly however, when modifying the proportion of organoid cell types, we observed an increased ev release when more ki + proliferating cells were present both in normal and in luad samples. summary/conclusion: our data show that patientderived lung organoids represent a novel model to study the role of intra-tissue heterogeneity in ev functions in the humans, leading to improved diagnosis. funding: this work was funded by the national competitiveness and excellence program nvkp_ - (national research, development and innovation office, hungary) and by the national excellence program in higher education (ministry of human resources, hungary). exosome mediate heart-adipocyte communication after myocardial ischaemia/reperfusion and impairs adipocyte endocrine function yajing wang, lu gan, dina xie, wayne lau, theodore christopher, bernard lopez and xinliang ma thomas jefferson university, philadelphia, usa introduction: by incompletely understood mechanisms, mi patients sustain systemic metabolic disorder. adipocytes are an important cellular type regulating energy homoeostasis. the impact of mi upon adipocyte function remains unknown. exosomes (exo) are critical vehicles mediating organ-organ communication. however, whether and how exo may mediate post-mi cardiomyocyte/ adipocyte communication have not been previously investigated. methods: adult male mice were subjected to mi/r. serum exo were isolated hours after r and incubated with t l cells for hours. the effects of exo upon adipocyte function were determined. results: compared to control, mi/r exo significantly altered the expression of genes known to be important in adipocyte function. go analysis revealed that genes associated with endoplasmic reticulum (er) function and adipocyte endocrine function are the primary two pathways altered by mi/r exo. venn analysis identified mi-rnas as cardiac-enriched, adipocyte-poor, and er function-related mirnas. rt-qpcr confirmed the mir- a/ a/ - family members are the most markedly increased mi-rnas in mi/r exo. incubation of t l cells with mi-r a mimic significantly downregulated edem , dsba-l, and pparn, and upregulated perk and chop. conversely, mi-r a inhibitor significantly decreased the impact of mi/r exo upon er function genes. additional studies demonstrated edem and pparγ (two critical molecules maintaining er function and adipocyte endocrine function) to be direct targets of mi-r a. one of the most significant endocrine molecules of adipocyte origin, adiponectin is regulated by pparn at the transcriptional level and by dsba-l at the post-translational level. we next determined whether mi/r exo may affect adiponectin expression/ assembly. incubation of t l cells with mi/r exo significantly inhibited total and high molecular weight adiponectin expression, an effect blocked by mir a mimic. finally, in vivo administration of gw (exo biogenesis inhibitor) or mir a inhibitor attenuated adipocyte er dysfunction and restored plasma adiponectin level in mi/r animals. summary/conclusion: we demonstrate for the first time that mi/r causes significant adipocyte er and endocrine dysfunction by exo mediated cardiomyocyte/adipocyte communication via mir- a/ a/ - . funding: nih and american diabetes association pancreatic cancer cell extracellular vesicles drastically alter the behaviour of recipient normal pancreas cells charles p. hinzman a , yaoxiang li a , meth jayatilake a , jose trevino b , partha banerjee a and amrita cheema a a georgetown university medical center, washington, usa; b university of florida health science center, gainesville, usa introduction: pancreatic cancer (paca) is predicted to become the rd leading cause of cancer-related deaths by . patients diagnosed with pancreatic ductal adenocarcinoma (pdac) have a -year survival ratẽ %. detection of pre-neoplastic lesions can potentially improve survival. however, there is currently no screening test for early stage detection. importantly, paca tumours are % non-tumorigenic cells. a better understanding of early paca oncogenesis is needed. cancer cells shed extracellular vesicles (evs) that are internalized by neighbouring and distant cells to induce a myriad of cancer progression events. we hypothesize that in early paca oncogenesis, evs mediate a behavioural change in surrounding normal cells, leading to the formation of this unique stroma. the purpose of this study was to develop a model to examine the phenotypic changes undergone by normal human pancreas cells when they are exposed to paca cell evs. methods: evs were isolated using differential ultracentrifugation with filtration from established (panc- , sw- , capan- and miapaca- ) and patientderived xenograft (ppcl- and ppcl- ) paca cell lines. cells were grown using ev-depleted fbs. ev isolations were validated and quantified using transmission electron microscopy, quantitative elisa, immunoblot and nanoparticle tracking analysis. normal pancreas cells (htert-hpne and hpde-h c ) were co-cultured with cancer cell evs for - hours. metabolic activity was measured using a mito stress test on a seahorse xfe extracellular flux analyser. results: we discovered that normal cells undergo vast behavioural transformations, including significant morphological changes, increased proliferation and an uncharacteristic invasive capability, when co-cultured with paca cell evs. these responses were ev dose dependent. further, paca cell evs metabolically reprogrammed normal cells, causing a bioenergetic switch, from a quiescent, aerobic profile to a highly energetic and glycolytic profile. summary/conclusion: our results indicate that paca cell evs confer enormous transformational properties to normal human pancreas cells in vitro. we hypothesize that evs impart distinct transformational properties to normal cells in vivo and this influence could unveil novel mechanisms regulating cancer onset and progression. these signals may be detectable before progression of early-stage paca to pdac, leading to the development of assays for earlier diagnosis in patients. further studies are underway to identify the biochemical mediators of these changes. plasma extracellular vesicles-mirnas released by hypoxic cells are associated to pro-tumorigenic and immunosuppressive microenvironment in lung cancer introduction: extracellular vesicles (ev) containing specific subset of functional biomolecules, such as micrornas (mirnas) are released by all cell types. it has been widely demonstrated that ev-mirnas from cancer cells can manipulate the tumour microenvironment modulating the gene expression of recipient cells. we previously identified a three levels risk classifier (msc) based on plasma-mirnas associated with lung cancer development and prognosis. the aim of this study was to investigate the potential role of ev- mirnas as mediators of pro-tumorigenic features. methods: evs were isolated from plasma of heavysmoker individuals with high (mscpos) or low (mscneg) risk of lung cancer by differential centrifugation method. purity of evs isolated was confirmed by sizing using nta and tem analysis and expression of ev-enriched proteins. mirna levels were analysed by dpcr. in vitro and in vivo analyses were used to assess the biological effect of plasma evs on different recipient cells. results: levels of mirnas in evs correlated with determination of whole plasma ( % of correlation with msc classifier). mscpos-evs stimulated d and d proliferation of non-tumorigenic epithelial cells through c-myc transfer into recipient cells. furthermore, mscpos-evs increased the ability of huvec to form tubular structures compared to mscneg-evs. in vivo co-injection of mscpos-evstreated huvec with a lung cancer cells resulted in an increase of tumour growth compared to mscneg-evs-treated huvec. mir- modulation in evs with mirna mimics or in recipient cells using mirna inhibitors demonstrated that this mirna is implicated in the autocrine proangiogenic modulation of huvec phenotype. mscpos-evs induced m polarization of macrophages both in vitro and in vivo. we demonstrated using synthetic oligonucleotides that mir- is responsible for the immunosuppressive modulation of these cells. regarding the potential origin of evs in mscpos individuals, we observed that hypoxia stimulated the secretion of evs containing c-myc from fibroblasts, mir- -evs from endothelial cells and mir- -evs from granulocytes. summary/conclusion: these data show that plasma evs of high-risk individuals display pro-tumorigenic features, as documented by their ability to induce a pro-angiogenic and immunosuppressive microenvironment suggesting an involvement of evs in lung cancer development. exploration of ev-associated metastatic targets on melanoma cells introduction: cancer cells secrete evs that may harbour metastatic proteins. previous studies have demonstrated the decrease of cd tetraspanin expression in melanoma cells are correlated with enhancing its metastatic potential. however, other proteins, such as cd , cd , met and nrp which are overexpressed in melanoma cells, are also associated with the spread of cancer. in this study, we sought to investigate the expression of metastatic proteins in evs derived from murine melanoma b f lineage. methods: b f cells were cultured in dmem supplemented with % fbs and antibiotics. the cells supernatant were harvested each hours, filtered through . µm and ultracentrifuged at x g for min at ºc to pellet evs. next, size and concentration was determined using nanoparticle tracking analyses technique, and the morphology of evs were analysed by negative-staining transmission electron microscopy (tem). the ev's surface protein were characterized by flow cytometry and protein content was profiled by mass spectrometry. results: our flow cytometry results have shown the presence of tetraspanins markers cd , cd and cd on vesicle´s surface. in addition, our assay demonstrated a diminished expression of cd molecule in comparison to cd and cd . we have profiled melanoma-evs by mass spectrometry, identifying the presence of proteins that may be associated to metastasis, such as cd , cd , met and nrp . summary/conclusion: these preliminary results are consistent with the literature and suggest that melanoma-derived evs harbour proteins, which may contribute to promote tumour metastasis. in our next step, we plan to generate b f lineages harbouring shrna vectors, in order to knockdown gene expression of cd , cd , cd , met and nrp to investigate the metastatic potential in vitro, in comparison to parental cells. we also may use syngeneic mice models to explore metastatic potential of genetically modified b f -derived cells. introduction: overexpression of her occurs in % of breast cancers and confers aggressive behaviour and poorer prognosis. thankfully, a number of drugs such as neratinib have been developed to target her , potentially providing substantial benefit for many patients. nevertheless, it is estimated that up to % of patients with her -overexpressing tumours do not gain benefit, as a result of innate or acquired drug-resistance. this study aimed to investigate if nano-sized membrane-surrounded extracellular vesicles (evs) released from drug-sensitive and drug-resistant cells reflect the her status of their cells of origin and thus have potential as minimallyinvasive biomarkers. methods: evs were isolated from conditioned media (cm) of her -positive cell lines (hcc and skbr ) and their neratinib-resistant counterparts (hcc -nr and skbr -nr) that we developed in our laboratory. evs from cm of a triple-negative breast cancer (tnbc) cell line variant, hs ts(i) , were evaluated as negative control for her . in brief, cm was centrifuged at g, for min x to get rid of any cells. the supernatant was then centrifuged at , g for h at ºc to collect evs. the resulting evs were washed in pbs, centrifuged as before, and resuspended in μl pbs. ev quantities were estimated by nanoparticle tracking analysis (nts). ev lysates were characterised by immunoblots, for established positive and negative ev markers. particle concentration as well as size distribution of evs were measured using the zetaview (particle metrix, germany). surface proteins on single evs were analysed by highresolution flow cytometry (fc), using an amnis imagestreamx mark ii. all data was submitted to ev-track (ev-track id: ev ). results: neratinib-resistant cell line variants were found to have reduced her protein expression compared to their respective drug-sensitive counterparts. neratinib-resistant cell line variants released fewer evs, when normalised per number of secreting cells, compared to their-drug sensitive counterparts. furthermore, evs from drug-sensitive cells carried her , while those from drug-resistant cells lacked her (similar to the evs from the tnbc cells); reflecting the her status of their cells of origin. summary/conclusion: this study indicates that a reduction in her protein expression is a mechanism by which cancer cells manifest resistance to her -targeted drugs (i.e. by making fewer her receptors available on the cells surface to accommodate the drugs activity). furthermore, ev-carried her seems to reflect the her status of their cells of origin. this suggest that analysis of her on evs in the peripheral circulation may help predict response to her -targeted drugs. thus, analysis of evs in appropriate cohorts of patients' specimens is warranted. introduction: rab a, a small gtpase involved in exosome biogenesis by regulating mve docking at the plasma membrane, and its expression level highly correlated with ohsv replication ability in vitro. oncolytic viruses is a newly promising therapeutic agent for cancer treatment. however, more than % of tumours naturally showed highly resistant to oncolytic viruses for unknown reasons. uncovering the underlying mechanisms of resistance to ohsv can offer potential therapeutic targets to enhance ohsv activity to kill tumour cells. in addition, it will give new insights into the identification of therapeutic biomarkers, which can be used to predict patient response to ohsv in clinical. methods: deep-sequencing data showed that lower expression level of rab a is present in ohsv resistant tumour cells compared to that in sensitive tumour cells. then an ohsv resistant mc tumour cell line was established by repeated injections with ohsv in mc tumour-bear mouse model. lastly, it was verified that ohsv resistance is associated with a downregulation of rab a and overexpression of rab a can rescue ohsv replication. results: ) the lower expression level of rab a is shown in ohsv resistant tumour cells compared to that in sensitive tumour cells shows in deep-sequencing data. ) furthermore, we established an ohsv resistant mc tumour cell line by repeated injections with ohsv in mc tumour-bear mouse model. similarly, in ohsv resistant mc cell line, rab a expression was lower than parental mc cells. and the release of exosomes and virus was decreased in ohsv resistant mc cell line. these results were confirmed by rab a sirna knockdown. ) we verified that in ohsv naturally resistant human cancer cell lines, ohsv resistance is associated with a downregulation of rab a and overexpression of rab a can rescue ohsv replication. summary/conclusion: downregulation of rab a expression restricts the efficiency of ohsv replication and the spreading ability of the released progeny virus which also provide rab a as a potential target and biomarker for ohsv cancer therapy. funding: these studies were supported by grants from shenzhen overseas high-calibre peacock foundation kqtd , shenzhen science and innovation commission project grants jcyj , jcyj to shenzhen international institute for biomedical research. inactivation of emilin- by proteolysis and secretion in extracellular vesicles favours melanoma progression and metastasis introduction: studies have demonstrated that melanoma-derived extracellular vesicles (evs) home in distal organs and sentinel lymph nodes favouring metastasis. although lymph node metastases are themselves rarely life threatening, they could be considered as one of the first step of metastasis in many cancer types. therefore, defining the mechanisms involved in lymph node metastasis and pre-metastatic niche formation in lymph nodes could bring the clue to block the metastatic process from the beginning. methods: we have characterized secreted exosomes from a panel of mouse melanoma models representative of low metastatic potential (b -f ), high metastatic potential (b -f ) and lymph node metastasis (b -f r ). we analysed the rna expression in cells and protein content of exosomes derived from mouse melanoma lymph node metastatic models by rna sequencing and mass spectrometry respectively. we validated expression by western-blot, qpcr and immunofluorescence. to define the mechanism of emilin- secretion cells were treated with the ev secretion inhibitor (non-competitive inhibitor of sphingomyelinase), gw . cell viability and cell cycle assays with an overexpression model (b -f -emilin- ) were also performed. in vivo experiments based on subcutaneous and intrafootpad injection for studying the role of this protein during melanoma progression were performed to define the relevance of our findings in vivo. human paraffin samples were analysed for emilin- expression by immunohistochemistry. results: we found a signature of over-expressed genes and hyper-secreted proteins in exosomes related to lymph node metastasis in the b mouse melanoma model. among them, we found that emilin- , a protein with an important function in lymph node physiology, was hyper-secreted in exosomes. interestingly, we found that emilin- is degraded and secreted in exosomes as a mechanism favouring metastasis. further, we found that emilin- has a tumour suppressive-like role regulating negatively cell migration. importantly, our in vivo studies demonstrate that emilin- overexpression reduced primary tumour growth and metastasis in mouse melanoma models. analysis in human melanoma samples showed that cells expressing high levels of emilin- are reduced in metastatic lesions. summary/conclusion: overall, our analysis suggests that the inactivation of emilin- by proteolysis and secretion in exosomes reduce its intrinsic tumour suppressive activities in melanoma favouring tumour progression and metastasis. funding: this work was supported by grants from mineco (saf r), asociación española contra el cáncer, fundación de investigación oncológica fero and mineco-severo ochoa predoctoral program. introduction: the amplification of erbb gene and the consequent overexpression of the encoded protein her have an important role in breast cancer classification at diagnosis and subsequent treatment decision with the anti-her monoclonal antibody trastuzumab. fish and ihc have been used so far to detect erbb gene amplification and her protein overexpression respectively in tissue biopsies. in this context, a major goal for liquid biopsies is to take advantage of the information carried by circulating tumourderived materials (such as extracellular vesicles (evs) and cell free dna (cfdna)) to noninvasively detect erbb gene status in the blood. however, the isolation of diverse tumour-derived materials from a single aliquot of patients' plasma and the accurate detection of cancer biomarkers is still challenging. methods: by adopting a recently published nickelbased evs isolation (nbi) protocol that allows for recovery of cfdna after evs isolation, we generated a high-sensitivity molecular assay to accurately detect erbb amplification and consequent her overexpression on a limited volume of plasma ( . ml) collected from breast cancer patients (stage i, ii and iii) at diagnosis. results: ) we detected erbb amplifications by droplet digital pcr (ddpcr) on the cfdna isolated from the plasma of erbb positive patients; ) we confirmed her overexpression on a subset of patients by setting up an antibody-based affinity reaction designed to detect her protein on the surface of the isolated evs; ) we succeeded in the quantification of her transcripts enclosed within evs by performing ddpcr in samples of patients showing a range of circulating tumourderived material. the specificity and sensitivity of these novel methodological assays were tested on a cohort of healthy individuals (n = ) and on a cohort of her positive (n = ) or her negative breast cancer patients (tnbc; n = ). summary/conclusion: here we report a pilot study on a novel multimodal method for erbb detection from a minimal amount of plasma. this approach integrates information from cfdna with evs-derived rna and proteins analysis. this proof of concept may ultimately translate into relevant clinical applications for disease diagnosis as well as for therapy selection and monitoring of disease progression. introduction: the biological and medical importance of exosomes recognized over the last decade has given rise to a crucial need for the discrimination between true evs and co-purified nanoparticles, such as lipoproteins, protein aggregates or debris. additionally, it is imperative to develop methods to identify and characterize ev sub-populations. considering ev biology and the reliability of labelled biomolecules, we developed both exogenous and endogenous labelling protocols, taking advantage of different dye properties which can target a multitude of compartments. this approach reveals key aspects of ev structure and integrity. methods: nanosized evs/exosomes were purified by size exclusion chromatography (sec) from model cell lines and human plasma. diverse dyes were orthogonally evaluated through different single particle and bulk analysis technologies, such as high-resolution cytometry, nanoparticle tracking analysis and plate fluorimeter. concomitant profiling of specific ev subpopulations was optimized using antibodies (abs) against tetraspanins and cell type specific targets and assessed by single particle analysis and elisa. to assess specificity of labelling protocols we used specific controls such as recombinant rfp expressing vesicles and purified lipoproteins. results: our ev staining protocols allowed for high labelling efficiency and unprecedent ev discrimination, quantification and characterization by combining single particle analysis and bulk measurements in simple matrices (saline buffers) and in complex biofluids (i.e. plasma). different approaches have diverse and complementary advantages (costs, capacity, sensitivity, informative readout) for implementation in research and diagnostic development flows, directly feeding in-house r&d and qc pipeline. summary/conclusion: overall, fluorescent evs are versatile and valuable tracers that can be applied in the optimization of pre-analytical and purification protocols, selection of target biomarkers and diagnostic assay calibration and validation. funding: endevor (por-fse - ) region tuscany and exosomics r&d program. subpopulations of tissue-derived extracellular vesiclesmethodological evaluation for vesicle size measurement introduction: introduction: subpopulations of extracellular vesicle (evs) are commonly classified by their different size, however, the ev size cut off is still under discussion. the aim of the study was to evaluate size range of six ev subpopulations using three methods: electron microscopy (em), nanoparticle tracking analysis (nta) and exoview™. methods: methods: ev subpopulations were isolated from melanoma tissues by a centrifugation based protocol recently established in our lab. large and small evs (levs and sevs) were isolated with differential ultracentrifugation and these were further separated into low and high-density fractions (ld and hd). size of ev subpopulations was then evaluated by: em introduction: small-extracellular vesicles have an important role in cell metabolism and cell-to-cell communication. moreover, sevs when secreted from cells are capable to act as mediators of various neurological diseases. however, sevs show heterogeneity and this may impact their functions. therefore, to characterize sevs at a single-particle level is important to better detail the associated biological activity. in this scenario, we innovatively propose the structured illumination microscopy (sim) as a technique able to complement the non-optical methods (transmission electron microscopy, tem) to analyse single sevs and their markers. methods: human plasma sevs were separated from healthy cognitive control (ctrl), mild cognitive impairment (mci) and demented subjects. the sevscontaining pellet was resuspended in % paraformaldehyde or % glutaraldehyde solutions. for sim, sevsenriched preparations were washed with the blocking solution and incubated with the primary antibody (l cam). the secondary fluolabelled antibody was then added. between the steps with the blocking solution, the primary and secondary antibodies, two ultracentrifuge steps were performed. the image acquisition was done on a nikon sim system with a x oil immersion objective. sevs were imaged with a d-sim acquisition protocol. tem was performed on mesh formvar copper-coated grids. sevs-enriched preparations were incubated first with the blocking solution and then, immunogold-labelled for cd . samples were counterstained with uranyl acetate and observed under a jeol ex electron microscope. data were recorded with a morada digital camera system. participation to the present study was approved by relevant local ethics committee of mendrisio and lugano hospital and written informed consents were obtained from subjects. results: for sim methodology, only vesicles in the range from to nm were detected, as the final resolution achieved was nm. instead, for tem, sevs under nm were identified. none of these methods provided relevant information about possible difference in morphology of the ctrl-, mci or demented subjects-derived sevs. summary/conclusion: even if both methods identified cd or l cam-positive vesicles, sim resolution and the complexity of the protocol represent some disadvantages respect to tem, that may be the first choice screening technique for evs analysis to be then completed by sim for particular tasks. fabrication of nanopore structures via conformal metal-film deposition for ev sensing kwanjung kim a , seung-min han b , soo-hyun kim c and sung-wook nam d luminex corporation, seattle, usa introduction: extracellular vesicles (evs) are membrane-derived structures that include exosomes, microvesicles, and apoptotic bodies. these evsreleased under normal physiological conditions as well as in the pathogenesis of neurological, vascular, haematological, and autoimmune diseaseshave been shown to transfer biological molecules such as protein and rna between cells, potentially transmitting signals. to understand more about these signalling mechanisms, there is a need for detecting and quantifying evs with cargo protein and rna in a reproducible and reliable manner. however, this has been challenging due to the small size of evs (ranging from to nm in diameter), and the lack of specific staining reagents. methods: here, we utilize the amnis® cellstream® flow cytometer, which enables high-throughput flow cytometry with increased sensitivity for detecting small particles. we demonstrate that a charge-coupled device (ccd)-based, time-delay-integration image capturing system can be used to detect and quantify evs and their cargo labelled with exoglow™-protein or exoglow™-rna. results: in this study, we show flow cytometry data quantifying ev samples that have been labelled with cargo markers for proteins and rna. the ev cargo contents along with the appropriate control samples will be shown. summary/conclusion: the ccd based detection of the cellstream flow cytometer has the sensitivity to quantify evs and their cargo. single ev imaging reveals novel ev biomarkers and dna cargo siobhan m. king a , ricardo bastos a and andras miklosi b a oni, oxford, uk; b oni (oxford nanoimaging ltd), oxford, uk introduction: extracellular vesicles (evs) are cellderived membrane-bound particles that range in size from - nm and carry active molecules such as dna, rna and proteins. upon secretion, evs can execute many biological functions such as initiating intracellular communication or regulating immune responses. depending on their origin evs have different characteristics and cargo, making them attractive candidates for early diagnostic and therapeutic applications. however due to their small size and heterogeneity, direct visualization and characterization of the surface markers expressed remains a challenge since these vesicles are below the resolution limit of standard light microscopy. methods: here, we describe a method that provides size analysis of single-evs, which falls below the diffraction limit of light. this was done with purified evs, immunostained using fluorescently labelled primary antibodies raised against ev surface markers (cd , cd , cd ), specific cargo such as dna and probed for tissue specific cargo. characterization of the molecular content and structural properties of surfaceimmobilized evs was performed using single-molecule localisation microscopy (smlm) on the nanoimager platform. results: multicolour smlm was used to detect up to three ev biomarkers showing successful characterization of the molecular signature for different ev subpopulations. the distribution of novel components on urinary evs were visualized for the first time using this approach. in addition, smlm revealed the presence of dna on both the surface and also as a cargo inside evs isolated from tumour cell culture media, which was validated using complementary biochemical characterization. summary/conclusion: smlm is a powerful technique for single-ev analysis and characterization. visualization of single-urinary evs enabled accurate sizing and further insights into novel components expressed on the subpopulation's membrane surface. together, the data demonstrates that the quantitative abilities of smlm can significantly enhance our understanding of evs, as structure, phenotypes, and cargoes can now be successfully resolved. introduction: working skeletal muscle is a common site for injury due to unaccustomed exercise with or without underlying pathology. direct analysis of skm injury requires invasive tissue biopsies. circulating extracellular vesicles (evs) are abundant in blood and have been shown to be enriched in microrna; profiles of which may reflect the state of tissues. evs may therefore serve as a non-invasive indicator of muscle injury and regenerative processes in vivo. methods: two consecutive bouts of muscle-damaging exercise (plyometric jumping and downhill running) were performed by healthy male volunteers. serum creatine kinase (ck) and plasma evs were analysed at baseline, and hr post-exercise. perceived muscle pain (pmp) was assessed at and hr post-exercise. large evs were isolated using a g centrifugation step, and small evs were isolated using qev columns. ev-enriched isolates were visualized using tem, and size and numbers were quantified using nta. based on nta results the highest particle fractions ( - ) were pooled for rna analysis. qpcr was done on plasma, large evs and small evs. a group of muscle and immune cell-important mirs were analysed by means of normalization to an exogenous control. results: ck and pmp increased post-exercise, providing evidence for muscle damage. tem revealed an abundant and heterogeneous pool of evs. a concomitant abundance of evs was seen with nta (mean = . x particles/ml plasma). mean ev diameters were ± nm across all timepoints. no change in ev size nor number was seen over time, however, mir- decreased at hr when compared to hr in the small ev isolate only. plasma displayed an immediate increase in myomirs- and − at hr, which returned to baseline at hr. in contrast, myomirs- b and remained elevated over the hr period. myomir- b and , as well as immune-mirs, did not change in evs or plasma as a result of the intervention. summary/conclusion: the decrease in mir- in small evs at hr is consistent with previous data. no decrease in mir- in large evs suggests specific packaging and hence a specific response to the muscle damage in small evs. more changes occurred in plasma myomirs suggesting less specific passive leakage into circulation from damaged cell membranes. funding: south african national research foundation pulsed electromagnetic fields potentiate the paracrine function of mesenchymal stem cells for cartilage regeneration yingnan wu a , dinesh parate a , eng hin lee a , zheng yang a and alfredo franco-obregón b a national university of singpaore tissue engineering program, yll school of medicine., national university of singapore, singapore, singapore; b biolonic currents electromagnetic pulsing systems laboratory, biceps, national university of singapore, singapore, singapore introduction: the mesenchymal stem cell (msc) secretome, via the combined actions of its plethora of biologically active factors, is capable of orchestrating the regenerative responses of numerous tissues by both eliciting and amplifying biological responses within recipient cells. mscs are "environmentally-responsive" to local microenvironmental cues and biophysical perturbations, influencing their differentiation as well as secretion of bioactive factors. we have previously shown that exposures of mscs to pulsed electromagnetic fields (pemfs) enhanced msc chondrogenesis. here, we investigate the influence of pemf exposure over the paracrine activity of mscs and its significance to cartilage regeneration. also, the subsequent extracellular vesicles analysis and isolation are processed for the understanding of how the pemfs affect stem cell evs and consequent differentiation induction. methods: conditioned medium (cm) was generated from mscs subjected to either d or d culturing platforms, with or without pemf exposure. the paracrine effects of cm over chondrocytes and msc chondrogenesis, migration and proliferation, as well as the inflammatory status and induced apoptosis in chondrocytes and mscs was assessed. the cms which have significant effects during chondrogenesis will be analysed by protein and mirna studies. results: we show that the benefits of magnetic field stimulation over msc-derived chondrogenesis can be partly ascribed to its ability to modulate the msc secretome. mscs cultured on either d or d platforms displayed distinct magnetic sensitivities, whereby mscs grown in d or d platforms responded most favourably to pemf exposure at mt and mt amplitudes, respectively. ten minutes of pemf exposure was sufficient to substantially augment the chondrogenic potential of msc-derived cm generated from either platform. furthermore, pemf-induced cm was capable of enhancing the migration of chondrocytes and mscs as well as mitigating cellular inflammation and apoptosis. the cms protein results in the significant promotion chondrogenesis condition showed an increase in proliferation and anti-inflammatory cytokines. summary/conclusion: the findings reported here demonstrate that pemf-stimulation is capable of modulating the paracrine function of mscs for the enhancement and re-establishment of cartilage regeneration in states of cellular stress. the pemf-induced modulation of the msc-derived paracrine function for directed biological responses in recipient cells or tissues has broad clinical and practical ramifications with high translational value across numerous clinical application. effects of extracellular vesicles from blood derivatives on osteoarthritic chondrocytes within an inflammation model introduction: the degenerative disease osteoarthritis (oa) is one of the leading causes of disability especially of elderly people. besides various treatment options depending on the severity of the cartilage degradation, the application of blood derived products such as platelet rich plasma (prp) are getting more and more popular in clinical practice due to its high concentration of platelets and the perceived high growth factor levels. drawbacks of using prp include high donor variability, discrepancies among preparation protocols and the presence of cells (platelets, leukocytes) which can evoke cellular processes, especially inflammation, when injected into the diseased tissue. one possibility is to isolate only extracellular vesicles (evs) from blood derivatives to overcome these problems. in the current study the effects of evs isolated from blood derivatives on oa chondrocytes within an inflammation model was investigated. methods: cd positive primary monocytes were isolated from citrate anticoagulated whole blood by magnetic bead sorting. monocytes were differentiated into resting m macrophages and activated into m macrophages according to published protocols. elisa measurements verified successful differentiation and activation as il β and tnfα levels increased. as control, thp monocytes were used. patient-derived oa chondrocytes were grown in well plates and co-cultivated with activated m macrophages which were seeded into thincerts and added to the wells representing the inflammation model. furthermore, cells were treated for hours with media containing fcs, ev depleted fcs or evs isolated from prp or hypact serum. results: successful differentiation and activation of monocytes (thp and primary monocytes) into m macrophages was demonstrated by elevated levels of the inflammatory cytokines il β and tnfα. within the inflammation model (co-culture of oa chondrocytes with m macrophages), addition of evs isolated from prp or hypact serum resulted in decreased secretion levels of il β and tnfα compared to media supplemented with either fcs or ev depleted fcs. summary/conclusion: taken together, evs from blood derived products might be chondroprotective and anti-inflammatory mediators which protect cartilage from being degraded during oa. funding: the work was jointly supported by the european fund for regional development (efre) and the fund for economy and tourism of lower austria, grant number wst -f- / - . α, (oh) d regulates growth cartilage matrix vesicle micrornas niels asmussen, michael mcclure, zhao lin, zvi schwartz and barbara boyan virginia commonwealth university, richmond, usa introduction: matrix vesicles (mvs) are small ( - nm in diameter) lipid bound extracellular organelles isolated from calcifying tissues including the growth zone (gc) of growth plate cartilage. α, (oh) vitamin d ( α, ) is a regulator of gc chondrocytes and the mvs they produce. these mvs are key players in the mineralization process and are selectively enriched with enzymes and growth factors. we found that mvs are also selectively enriched with micrornas (mir), including mir- , mir- and mir- . the aim of this study was to determine the regulatory role of α, in the packaging of mirna in mvs by gc cells. methods: gc cells were isolated by enzymatic digestion from costochondral gc cartilage harvested from wk-old male sprague dawley rats (iacuc approved). confluent fourth passage gc cell cultures were treated with - m α, or vehicle for h. media were removed, cell monolayers digested with trypsin and cells and mvs isolated by differential ultracentrifugation. rna was precipitated from cells and mvs. small rnaseq data were trimmed, aligned and counted before undergoing differential expression analysis. experimental groups had an n = per variable. significant differences (p < . ) were determined using r v . . . results: α, treatment altered expression of mv mirs compared to control mvs, whereas cell mirnas were differentially expressed. . % of significantly up or down regulated mir found in mvs overlapped between α, and vehicle groups with the remaining being uniquely differentially expressed. α, increased mv mir- and decreased mir- - p two mirs known to regulate osteoblast proliferation ( increases, decreases). summary/conclusion: α, regulates gc chondrocyte and mv behaviour and this study demonstrates that it also impacts the mir packaging within mvs. mir discovered in mvs have been demonstrated to impact chondrocyte behaviour and the present study indicates that α, regulates the growth plate through mir delivered by mvs. introduction: increasing evidence has proposed extracellular vesicles (evs) as mediators of many of the therapeutic features of mesenchymal stromal cells (msc) that have been widely studied in clinical trials over the last years. these evs have been recognized as nanocarriers of important biological information, which play a central role in cell-to-cell communication. in this context, evs can be used as an alternative to a cell-based therapy, with reduced risks. the present work aimed to evaluate the impact of different culture conditions on the msc-derived evs molecular composition through fourier-transform infrared (ftir) spectroscopy. methods: evs derived from msc from different sources, expanded in two different culture media ((xenogeneic -free (xf) vs serum-containing medium (fbs)) were characterized by ftir spectroscopy, a highly sensitive, fast and high throughput technique. moreover, principal component analysis (pca) of preprocessed ftir spectra of purified evs was conducted, enabling the evaluation of the replica variance of the evs chemical fingerprint in a reduced dimensionality space. for that, different pre-processing methods were studied as baseline correction, standard normal variation and first and second derivative. results: evs secreted by mscs cultured with serumcontaining medium presented a more homogenous chemical fingerprint than evs obtained with xf medium. the regression vector of the pca enabled to identified relevant spectral bands that enabled the separation of samples in the score-plot of the previous analysis. ratios between these spectral bands were determined, since these attenuate artefacts due to cell quantity and baseline distortions underneath each band. statistically inference analysis of the ratios of spectral bands were conducted, by comparing the equality of the means of the populations using appropriate hypothesis tests and considering the significance level of %. it was possible to define ratios of spectral bands, that can be used as biomarkers, enabling the discrimination of evs chemical fingerprint in function of the culture medium used for msc expansion and the msc donor. summary/conclusion: this work is a step forward into understanding how different culture conditions affect msc-derived evs characteristics. funding: fundação para a ciência e tecnologia (ptdc/equ-equ/ / , uidb/ / ). performance qualification for microflow cytometers: understanding technical limitations to improve your research desmond pink a , michael wong a , diana pham a , renjith pillai a , leanne stifanyk b , sylvia koch b , rebecca hiebert a , oliver kenyon c and john lewis a a nanostics, edmonton, canada; b dynalife, edmonton, canada; c apogeeflow systems, hemel hempstead, uk introduction: as microflow cytometry and other techniques mature as validated modalities for analysing extracellular vesicles (ev), there has been a concerted effort to improve reproducibility . in order for this reproducibility to occur there has to be a critical understanding of advantages and limitations for each technology. for microflow cytometry, several instruments are available to analyse evs. each platform has different limitations as well as advantages over other platforms. to provide the optimal data for your specific research, it is critical to understand the limitations of your platform. to accurately define these limitations, a performance qualification (pq) of your instrument should be undertaken. methods: an apogee a platform was used in these experiments. experiments were designed with expected ranges and cut-offs for acceptance criteria.initial tests included autosampling of a well plate with either single or double aspiration, single sample reproducibility and linearity proportional to flow rate. other experiments designed to show machine performance included minimal time to achieve valid data, sample volume required for double aspiration, determination of coincidence; detection sensitivity using a spiked sample; flow rate stability for extended periods ( - minutes) . tests should also be performed to determine carryover at a range of sample concentrations. if present, the means to remove contaminating samples should be determined. any performance tests should be applicable to any instrument in the field. results: auto-sampling helped demonstrate consistent data; reproducibility of total events and biomarkers was - % c.v. detected bead concentrations were linear with flow rates between . and . ul/min. double well aspirations provided similar data with aspirations between - ul. valid data was achieved for a low abundant target (~ - events/ul) after only s, < %c.v. detection sensitivity was determined to be~ / , . carryover ranges were determined in the presence of nominal unstained serum. an optimal number of machine washes was determined. some membrane stains, such as cell mask and cfse require much more rigorous cleaning to remove stain carryover. summary/conclusion: to improve data reproducibility, performance qualification of any instrument is key. operational limitations help define optimal performance parameters of any technology. understanding the types of experiments to perform for your particular type of characterization technology depends on the requirements you set for your research. a good performance test should be applicable to any related instrument in the field. funding: funding provided by nanostics, the alberta cancer foundation, and alberta innovates. introduction: cancer cells release more evs than normal cells and evs secreted from tumour cells can promote tumour progression, survival, invasion and angiogenesis. the ev cargo may mirror the altered molecular state of the cell of origin. therefore, evs have potential for the development of non-invasive markers for early detection of cancers. evs and their cargo also have the potential to be multiplexed with other molecular markers or screening modalities (e.g., imaging) to develop integrated molecular-based computational tools for the early detection of cancer. one challenge with using evs as a biomarker is the lack of robust and reproducible methods for the isolation of a pure vesicular population. there is a lack of clear consensus for an optimal method of isolation of a pure ev population that is devoid of contamination with similar-sized vesicles of different origins. there is also a lack of standards to ensure rigour reproducibility. methods: the current funding opportunity announcement (foa), par - , is promoting research on the isolation and characterization of extracellular vesicles (evs) and their cargo for the discovery of biomarkers to predict cancer and cancer risk. results: the previous cycle of this foa, par - / , successfully funded r and r grants. these awards are focused on proteomics profiling of evs, effect of methodological and biological variability, asymmetric-flow field-flow technology, therapeutic monitoring, lss and sers lab on a chip optical spectroscopic, evs in obesity-driven hepatocellular carcinoma, nanoscale structure and bio-molecular heterogeneity, urinary ev dna, and ev markers in paediatric cancers. progress from these awardees have shown separation of two discernible exosome subpopulations and identified a distinct nanoparticle, the exomere (nature cell biology, ); and have shown that large-evs contain the entire genome of the cell of origin, including cancer-specific genomic alterations (journal of extracellular vesicles, ). protocols that critically evaluate and refine the existing methodologies to improve utilization of evs in clinical use have been shared (nature protocols, ). summary/conclusion: drs. sudhir srivastava and matthew young are the programme directors for the par which began accepting applications on january . this and other ev funding opportunities will be discussed. funding: this is a funding opportunity announcement offered by the national cancer institute. introduction: traumatic brain injury (tbi) is characterized by diverse primary mechanisms of injury that lead to the development of secondary pathological cascades that drive neurological deficit post-tbi. inability to separate patients based on the presence of these different endophenotypes represents a major challenge for diagnosis and treatment of tbi. extracellular vesicles including exosomes isolated from patient plasma have emerged as promising potential biomarkers for tbi due to their ability to cross the bbb into systemic circulation with molecular cargo intact for analysis. we have developed a novel microfluidic platform for rapid isolation of brain-derived evs providing a tool with which the biochemical state of neurons and glia can be directly assessed post-tbi. we used the ultra-sensitive, single molecule array (simoa) to quantify concentrations of protein biomarkers from the plasma and brain derived evs from mild tbi patients and controls. by combining multiple protein biomarkers, we could discriminate mtbi patients from controls in both the training and the blinded test set. building on this work, we are also characterizing single ev heterogeneity of neuron derived evs by developing novel droplet based digital assay for single ev quantification at ultra-low concentration. droplet based assay for single ev analysis would potentially be very informative for early disease diagnosis and therapy decision. methods: our microfluidic platform for ev isolation consists of tracked-etched membranes with millions of nanopores ( nm), coated with a magnetic film (nife) to precisely capture immunomagnetically labelled brain-specific evs from plasma. single molecule array (simoa) was used to quantify concentrations of the protein biomarkers (tau, uchl- , nfl, gfap, il , il , and tnf) in the plasma and brainderived exosomes of mild tbi (mtbi) patients and controls. to identify single ev, we applied droplet based enzyme-linked immunosorbent assay and encoded the fluorescent signal for single ev quantification within parallelized microfluidic platform. results: we report that concentrations of plasma and exosome gfap, nfl, and uchl were elevated in mtbi patients compared to controls (p < . ), and that each of these biomarkers are uncorrelated with one another. discrimination of mtbi patients from controls was most accurate when machine learning algorithms on the panel of biomarkers. specifically, combining plasma nfl, gfap, il and tnf-with tau from glur + evs showed % accuracy with % sensitivity and % specificity. summary/conclusion: this data suggests that neuronderived exosomes contain information that characterizes the injured and recovering brain. it also suggests that analysis of a panel of biomarkers from a combination of both blood and exosomal compartments could lead to more accurate diagnosis of mtbis. ps . = op . l cam is not associated with extracellular vesicles in cerebrospinal fluid or plasma maia norman, dmitry ter-ovanesyan, wendy trieu and david walt wyss institute, boston, usa introduction: neurons in living psychiatric and neurological patients are inaccessible for cell type specific analysis of rna and protein. our understanding of these diseases instead relies upon imperfect sources of biochemical information such as post-mortem brain tissue analysis and animal models. furthermore, there is a paucity of biochemical assays available to diagnose and manage brain diseases. extracellular vesicles (evs) present an opportunity to noninvasively sample the contents of neurons in cerebrospinal fluid (csf) and plasma. in order to isolate neuron-derived evs (ndevs), a cell type specific transmembrane protein is necessary for immunocapture. l cam, a protein abundant on the surface of neurons, has been used extensively in the literature for ndev isolation. however, l cam exists in humans in several isoforms without a transmembrane domain, and as such it can be secreted as a free protein. additionally, the ectodomain of l cam can be cleaved off of the cell surface in physiological processes. it remains to be demonstrated whether the l cam found in csf and plasma is ev associated, or if it is instead a spliced or cleaved isoform behaving as a free protein. methods: using single molecule arrays (simoa), a digital form of elisa, as well as western blotting, we quantify ev markers (cd , cd and cd ) as well as l cam and albumin. we use these assays to determine in which fractions of size exclusion chromatography (sec) and density gradient the l cam appears. we also immunocapture l cam from csf and plasma and perform western blots for the internal and external domains of l cam. results: simoa and western blot analysis of sec and density gradient fractions demonstrated that while the ev markers peaked all together, l cam eluted in the free protein fractions along with albumin in both csf and plasma. when immunoprecipitation was performed, western blotting revealed different isoforms of l cam in csf and plasma. summary/conclusion: our data utilize a multitude of distinct techniques that converge to demonstrate that l cam is not associated with evs in csf or plasma. furthermore, our data suggest that the isoforms present in csf and plasma are distinct, which indicates that the l cam in plasma is likely not coming from the brain. this data call into question the utility of l cam as a ndev marker and point to the need to find novel candidates for immunoprecipitation of ndevs. introduction: in parkinson's disease (pd), α-synuclein (α-syn) aggregates known as lewy bodies (lb) are present in both the central and peripheral nervous system. furthermore, data showing that α-syn can spread from pd patients to transplanted tissue has led to a new theory postulating that pathological forms of α-syn can drive disease by "infecting" healthy cells and corrupting normal proteins. the exact routes and mechanisms involved in such spreading are yet to be fully understood but it is known that α-syn can be secreted from cells and transported via extracellular vesicles (ev). ev derived from erythrocytes (eev) are of particular interest in this regard as they have been shown to contain α-syn. methods: we first optimized a protocol for the isolation of fluorescently labelled human eev. the capacity of these eev to cross the blood-brain barrier (bbb) was then evaluated in vitro using a boyden chamber composed of primary human brain endothelial cells. next, eev were added to a more complex and physiologically relevant d human bbb model including ipsc-derived brain microvascular endothelial cells. in both in vitro protocols, flow cytometry was performed on media collect from each compartment to determine the number of eev. immunofluorescence was performed to assess the localization of fluorophore tagged eev. we are also using an in vivo paradigm for the extraction and testing of eev spread and an in situ cerebral perfusion (isbp) model in wt mice to investigate if and how eev cross the bbb using confocal microscopy. results: in both in vitro models, flow cytometry analyses showed that fluorescently tagged eev added to the luminal side traversed the endothelial cell barrier. confocal analysis revealed that some eev could also be found within endothelial cells themselves. ongoing experiments are being conducted in our newly developed d bbb to further confirm these results. our preliminary in vivo experiments showed that fluorescently labelled beads, similar in size to eev, used in the isbp experiments are detectable in the brain parenchyma of injected wt mice using confocal microscopy. preliminary work also includes isbp injections of eev in -month-old wt mice, (n = /groups) derived from pd patients (at different stage of the disease) and a healthy individual as a control. summary/conclusion: our preliminary data suggests that eev can indeed move across the bbb in both in vitro and in vivo experimental setups. ongoing experiments will determine the dynamics and processes involved in this transport and whether eev can precipitate and/or exacerbate disease-related features. introduction: neuroblastoma accounts for % of childhood cancer mortality. amplification of the oncogene n-myc is a well-established poor prognostic marker for neuroblastoma. whilst n-myc amplification status strongly correlates with higher tumour aggression and resistance to treatment, the role of n-myc in the aggressiveness of the disease is poorly understood. exosomes are released by many cell types including cancer cells and are implicated as key mediators in cell-cell communication via the transfer of molecular cargo. hence, characterising the exosomal protein components from n-myc amplified and nonamplified neuroblastoma cells will improve our understanding on their role in the progression of neuroblastoma. methods: in this study, comparative proteomic analysis, nanoparticle tracking analysis, transmission electron microscopy, rnai-based knockdown, migration and cellular survivability assays were performed to understand the role of exosomes isolated from cells with varying n-myc amplification status. results: label-free quantitative proteomic profiling revealed proteins that are differentially abundant in exosomes released by the n-myc amplified and nonamplified neuroblastoma cells. gene ontology-based analysis highlighted the enrichment of proteins involved in cell communication and signal transduction in n-myc amplified exosomes. treatment of less aggressive sh-sy y cells with n-myc amplified sk-n-be cell-derived exosomes increased the migratory potential, colony forming abilities and conferred resistance to doxorubicin induced apoptosis. incubation of exosomes from n-myc knocked down sk-n-be cells abolished the transfer of resistance to doxorubicin induced apoptosis. summary/conclusion: these findings suggest that exosomes could play a pivotal role in n-myc-driven aggressive neuroblastoma and transfer of chemoresistance between cells. ps . = op . results: murine ctl evs were broadly divided into two populations that were eluted at low salt (l-s: . m- . m nacl) and high salt (h-s: . m- . m nacl) concentrations. l-s ctl evs were abundant in late endosome-related proteins, integrins, rabs, and effective mirnas, indicating exosome characteristics, and had biological activity for preventing tumour metastasis after depletion of tumoural mesenchymal cell populations by intratumoral administration (see seo et al., nat. commun. : , ) . contrary, h-s ctl evs were rich in dna, core histones, ribosomal proteins, cytoskeleton proteins, and housekeeping proteins, considering microvesicles and apoptotic bodies, and easily phagocytosed by a kupffer cell line (kup : kitani et al., results immunol. : - . ). in addition, there were noticeable differences between ls and h-s ctl evs in the negative zeta potential width and membrane glycan structure. summary/conclusion: thus, ion exchange can be an optimal mass fractionation method for discriminating bioactive exosomes from cargos for nucleic acids in evs. funding: cryotem was conducted in nara institute of science and technology (naist), supported by nanotechnology platform program (synthesis of molecules and materials: # ) of the ministry of education, culture, sports, science and technology (mext). this work was supported by grants from the japan agency for medical research and development (translational research network program (nagoya univ. seeds a )) and the japan science and technology agency (crest [jpmjcr h ]). clic is essential for breast cancer metastatic competence and predicts disease outcome introduction: metastatic breast cancer is a consequence of complex interactions between cancer cells and the host. clic , a member of a conserved gene family in the glutathione-s-transferase superfamily, mediates crosstalk between tumour and host in breast cancer. tcga and metabric data indicated that elevated clic expression was associated with breast cancers from young women, those with poor prognosis, and those with early stage metastatic disease. methods: since bulk tumour analysis does not distinguish between cancer and host stromal cells, we used genetic modifications of established syngeneic breast cancer mouse models to evaluate the contributions of clic in the host or tumour cells to develop metastases. results: experimentally, the essential clic host contributions for metastatic competence were related to circulating levels of pro-metastatic soluble factors, neoangiogenesis, tumour cell attachment to lung tissue, myofibroblast differentiation, and leukocyte migration. clic was detected as cargo in circulating extracellular vesicles (evs) from breast cancer patients. similarly, circulating evs from tumour-bearing mice have abundant clic in comparison to those from mice bearing tumours that lack clic . tumour cells released evs that induced myofibroblast conversion of wildtype but not clic ablated lung fibroblasts. summary/conclusion: these results illuminate clic expression as a prognostic marker for breast cancer patients, and experimentally, clic is a critical host factor for metastatic competence and potential target within host tissues for anti-metastatic therapy. funding: this work was supported by the intramural program of the national cancer institute under project zia bc . the application of flow cytometry in an ev-based liquid biopsy for the detection of cancer multidrug resistance in myeloma gabriele de rubis a , krishna sunkara a , sabna rajeev krishnan and mary bebawy b a laboratory of cancer cell biology and therapeutics, discipline of pharmacy, graduate school of health, the university of technology sydney, australia, sydney, australia; b the university of technology sydney, sydney, australia introduction: multiple myeloma (mm) is an incurable cancer of bone-marrow plasma cells. it is characterized by unpredictable and highly variable therapeutic response and poor survival, attributed to the development of multidrug resistance (mdr) to chemotherapy. presently, no clinical procedures allow for a continuous, minimally invasive monitoring of mdr. we identified unique extracellular vesicle (ev) populations in the blood of myeloma patients, which serve as biomarkers of disease evolution and mdr to combination chemotherapy. we describe approaches used to optimise the use of flow cytometry (fcm) for ev summary/conclusion: although further investigation is required, our results potentially promise an effective and inexpensive priming agent (i.e., ethanol) for the production of anti-inflammatory msc-evs. this, combined with the significant increase in yield via d dynamic culture, presents practical solutions to both ev manufacturing scalability and potency issues. donor source affects potency of mesenchymal stem cell-derived extracellular vesicles introduction: mesenchymal stem cell (msc) therapies have been heavily investigated for their utility in applications such as wound healing and regenerative medicine due to their angiogenic, immunomodulatory and anti-apoptotic effects. recently, msc-derived extracellular vesicles (evs) have been implicated as primary effectors in msc-based therapies via protein and nucleic acid cargo transfer to patient cells. msc evs represent a superior alternative to msc-based therapies, as they lack the ability to replicate and are much smaller in size, circumventing related safety concerns such as immunogenicity, teratoma formation and blood vessel occlusion. however, a key drawback with msc therapies in general is their variable therapeutic potency, which is dependent on donor source. as a cell derived therapeutic, this crucial limitation is hypothesized to exist in msc evs as well. here, we demonstrate the varying bioactivities of isolated msc evs from differing donors and tissue sources. methods: six separate msc lines were obtained from different donors, with three msc lines derived from donor adipose tissue, and the other three from the bone marrow of separate individuals. evs were isolated from each msc line at passage via differential centrifugation and ultrafiltration. these isolated msc evs were then characterized for size/concentration via nanoparticle tracking analysis, and ev markers (tsg , alix, cd ) via western blot. pro-vascularization capacities of msc evs were determined by a gap closure assay using human umbilical cord vein endothelial cells (huvecs). results: characterization of msc evs revealed similar sizes and ev marker expression across donor groups, frontiers in chemistry, submitted funding: this work was funded by the momentum programme (lp - ), by the national competitiveness and excellence program catalan institution for research and advanced studies (icrea) proteomic profiling of retinoblastoma-derived exosomes reveals potential biomarkers of vitreous seeding angel montero carcaboso g , andrea petretto b , franco locatelli a and angela di giannatale a a department of paediatric haematology/oncology and cell and gene therapy, irccs, ospedale pediatrico bambino gesù ps : separation and concentration a laboratory of clinical biophysics, faculty of health sciences ps : diverse ev biomarkers chair: pia siljander -faculty of biological and environmental sciences urinary evs were isolated using low vacuum filtration method followed by ultracentrifugation. raman spectra of urinary evs were recorded using a renishaw invia raman spectrometer. data analysis was performed using principal component analysis (pca) and hierarchical cluster analysis (hca). the size distribution and morphology of evs were analysed by transmission electron microscopy and nanoparticle tracking analysis methods. results: average raman spectra obtained for urinary evs from studied groups showed differences in intensities of specific bands in the region of - cm- . we found significant correlations between mean area under curve (auc) calculated for raman bands (phenylalanine, dna, proteins, lipids and amide i) and selected clinical parameters such as: egfr, serum creatinine, glucose, urine creatinine. chemometric methods showed spectral pattern responsible for separation between studied groups. nta measurements visualized evs with size of . ± . nm. summary/conclusion: our results showed that characteristic raman spectra of urinary evs are promising candidates for new, non-invasive biomarkers for dkd isolation of circulating extracellular vesicles and cfdna allows for erbb detection in a single aliquot of breast cancer patients plasma michela notarangelo a , mattia barbareschi b , antonella ferro c , orazio caffo c , vito d'agostino a and francesca demichelis d a department of cellular results: results: tissue-derived large and small evs showed difference in size (mean nm vs nm) when examined by em, whereas nta and exoview™ were unable to show a clear difference between the populations (nta: mean . nm vs nm nta can only detected vesicles above nm and exoview™ only measures vesicles between - nm. of the three different methods, em analysis of single vesicles visualized in a significant number of micrographs was the only one able to distinguish ev subpopulations by size. funding: funding: swedish research council knut och alice wallenberg foundation imaging of human plasma-derived small-extracellular vesicles using transmission electron microscopy and structured illumination microscopy mitovesicles: a new extracellular vesicle of mitochondrial origin altered in ageing and neurodegeneration alldred b , chris goulbourne b , hediye erdjument-bromage d , monika pawlik b , mitsuo saito e , mariko saito f , stephen d. ginsberg b an in vitro and in vivo perspective on the role of erythrocyte-derived extracellular vesicles in parkinson's disease pathology frédéric calon c , Éric boilard f and francesca cicchetti b a centre de recherche du chu de québec and faculté de médecine, département de psychiatrie & neurosciences département de microbiologie-infectiologie et d'immunologie evidences on microalgal extracellular vesicles: a morphological assessment antonella bongiovanni i , ales iglič j and veronika kralj-iglič j a laboratory of clinical biophysics, faculty of health sciences a faculty of dentistry, national university of singapore, singapore, singapore, singapore; b institute of medical biology, agency for science, technology and research, singapore, singapore, singapore; c exosome of cancer-associated fibroblast induce anti-cancer drug-resistance of nsclc so-young kim a and yeon-ju lee b a chonnam national university hwasun hospital biomedical research institute, gwangju, republic of korea; b chonnam national university hwasun hospital biomedical research institute, gwangju, republic of korea introduction: the understanding of interaction mechanisms between cancer cells and the tumour microenvironment (tme) is crucial for developing therapies that can arrest tumour progression and metastasis. cafs are the major constituent of the tme in many cancers. recent studies indicate that exosomes harbour the potential to regulate proliferation, survival and immune status in recipient cells. most of the current studies are focused on cancer cell secreted exosomes; and little is known about cafderived exosomes and their influence on cancer cells. methods: nsclc cell lines (pc gr) and mrc (normal fibroblast cells) were grown in culture with exosome-free fbs. cutured media was filtrated by tangential flow filtration systems. exosomes in supernatant were isolated with the exoquick-tc™ system. considering the important role of cell extrinsic factors on cell growth and survival, we assessed whether factors contained in the mpa exosome could affect proliferation and survival of recipient cancer cells. cells were then treated with μm osimertinib or pbs for days prior to cell quantification of live cells.to investigate mechanisms of resistance to osimertinib mediated by ma or mpa-exosome in nsclc cell lines, we test cell viability by crystal violet assay in trametinib or osimertinib treated after pretreated ma or mpa-exosome, pc gr during days. we will investigate how mpa-exsomes activate erk signalling pathway in pc gr cells to induce antitumor effects by western blot. results: mpa exosome increased proliferation of pc gr cells by more than % compared to control pbs. pc gr cells grown in mpa-exosome and subsequently treated with osimertinib showed a significant increase in cell survival compared to pc gr cells grown in ma-exosome. osimertinib is used to treat egfr-mutant non-small cell lung cancer (nsclc) with tyrosine kinase inhibitor resistance mediated by the egfr t m mutation.these data show that "mrc -pc gr-crosstalk factors" affect proliferation and adaptive drug resistance of cancer cells. mpa-exosome mediates erk signalling activation and attenuated after treatment of um osimertinib. summary/conclusion: cafs support cancer growth and invasion. co-cultured nsclc with mrc lung fibroblast increased cell viability and exosomal mir- through the tgf-ß pathway in treatment osimertinib. exosomal mir- up-regulation in cocultured nsclc with mrc- induced drug resistance to drug-induced apoptosis. thus, exosomal mir- expression in co-cultured nsclc with mrc may support drug tolerance persister cells. introduction: neural stem cell (nsc) therapy has shown promise for brain repair after injury or disease mostly through bystander effects. nevertheless, the translation of nscs derived from human induced pluripotent stem cells (hipscs) to the clinic remain constrained due to safety issues, which include immunogenic risks, tumorigenesis potential, and incomplete differentiation. a way to avoid these issues is by using extracellular vesicles (evs) generated from nscs, as nsc-evs likely have similar neuroprotective properties as nscs and are amenable for non-invasive administration as an autologous or allogeneic off-the-shelf product. however, this would require reliable purification and characterization processes, and testing of evs for composition and biological properties. methods: we generated evs from hipsc-derived nscs using a combination of ion-exchange chromatography (iex) and size-exclusion chromatography (sec) and investigated their composition through small rna sequencing and proteomics. we also performed in vitro and in vivo experiments to determine their biological and functional properties. results: iex and sec facilitated purification of hipsc-nsc evs nearly to homogeneity, which expressed ev markers such as cd , cd , cd , and alix with a mean size of nm. small rna sequencing revealed enrichment of mirnas related to different neuroprotective signalling pathways and diverse metabolic functions consistent with their role in cell-cell communication. the proteomic analysis identified > , proteins, including ev markers and many other proteins involved in central nervous system function and cellular processes. the evs also displayed antiinflammatory activity in an in vitro mouse macrophage assay. intranasal (in) administration of nsc-evs resulted in their rapid incorporation by neurons, microglia, and astrocytes in virtually all regions of the brain. functionally, in administration of nsc-evs reduced inflammatory activity in the brain in a model of status epilepticus, and increased hippocampal neurogenesis in the adult brain. summary/conclusion: biologically active evs with antiinflammatory and neurogenic properties could be purified and harvested from hipsc-nscs. such evs also contain many mirnas and proteins that are of interest for brain repair after injury or disease. funding: supported by a grant from the national institute of neurological disorders and stroke ( r ns - to a.k.s.) introduction: extracellular vesicles (evs) generated from human bone marrow-derived mesenchymal stem cells (hmscs) display anti-inflammatory and neuroprotective properties. our recent study has shown that intranasally (in) administered hmsc-evs incorporate into significant percentages of neurons and microglia in virtually all regions of the intact as well as the injured forebrain within hours (kodali et al., int j mol sci, ) . in this study, using a rat model, we investigated the efficacy of a low dose of hmsc-evs administered intranasally for alleviating the abnormal plasticity of newly born neurons and the activation of microglia after se. methods: approximately billion evs were dispensed bilaterally into both nostrils of young f rats that experienced two hours of kainate-induced se. animals were euthanized seven days after se, and brain tissue sections were processed for immunohistochemical staining of neun (a neuronal marker), dcx (a marker of newly born neurons), iba- (a microglial marker), and parvalbumin (pv) and reelin (markers of subclasses of interneurons). in addition, activated microglia were quantified using iba- and cd dual immunofluorescence. results: in administration of evs reduced the seinduced loss of pyramidal neurons in the hippocampal ca subfield. also, ev administration after se maintained higher levels of pv+ interneurons in the dentate gyrus. furthermore, ev treatment after se modulated abnormal neurogenesis, which was evidenced by a the role of small extracellular vesicles in chronic neuropathic pain zhucheng lin a , renee jean-toussaint b , yuzhen tian b , ahmet sacan a and seena ajit b a drexel university, philadelphia, usa; b drexel university college of medicine, philadelphia, usa introduction: chronic pain is the most prevalent, disabling, and expensive public health condition in the usa. exosomes are - nm extracellular vesicles that can transport rnas, proteins, and lipid mediators to recipient cells via circulation. exosomes can be beneficial or harmful depending on their source and contents. we hypothesized that the composition of small extracellular vesicles (sevs) can be altered following nerve injury and these alterations can provide insight into how the body responds to neuropathic pain. methods: to characterize changes following nerve injury, small extracellular vesicles (sevs) were purified by ultracentrifugation from mouse serum four weeks after spared nerve injury (sni) or sham surgery. mirna profiling and proteomics analysis using tandem mass spectrometry were performed to determine differential expression of mirnas and protein cargo respectively. for in vivo studies, sevs were administrated intrathecally into the mouse lumbar region. animals were evaluated for mechanical and thermal hypersensitivity over days after injection. results: our mirna profiling showed a distinct mirna signature in sni model compared to sham control. proteomics analysis detected gene products. of these, were unique to sni model. neuropathic pain can induce the activation of the complement cascade and we observed significant upregulation of complement component a (c a) in sevs from sni model. intercellular adhesion molecule (icam- ), required for the leukocyte recruitment, adhesion and homing of exosomes was also upregulated in sevs from sni model compared to sham control. administration of sevs from sni model increased paw withdraw threshold in naïve recipient mice and inflammatory pain model, indicating a protective role for sevs in attenuating chronic pain. summary/conclusion: our preliminary studies suggest a critical role for sevs cargo in regulating pain. additional studies are ongoing to determine the functional significance of alterations in sevs composition using mouse models of pain. introduction: amyotrophic lateral sclerosis (als) is a progressive adult-onset neurodegenerative disease caused by selective motor neurons (mns) death. the rapid disease progression strongly suggests that cell-tocell spreading of noxious factors could take place in als pathogenesis. extracellular vesicles could potentially spread the disease. in this study, we characterized large (levs) and small extracellular vesicles (sevs) isolated from plasma of sporadic als patients and healthy controls and determined their different composition in order to understand their neuroprotective or neurotoxic role in als pathogenesis. methods: levs and sevs were isolated from plasma of als patients and healthy volunteers by differential centrifugation and characterized by nanosight ns . cd , cd , cd , cd a and annexin v were used for flow cytometry. sod , tdp , fus protein level was investigated by western blot. for raman spectroscopy, evs were dried on top of a caf slide and raman spectra were acquired using a nm laser line. mirna libraries were prepared by truseq small rna library kit (illumina). results: the mean size both for levs and for sevs resulted increased in als patients compared to controls. levs derived from als patients were enriched in sod- , tdp- and fus proteins compared to ctrls. sevs showed a distinct spectral pattern from levs. in addition, levs of als patients were richer in lipids and had less intense bands relative to aromatic aminoacids compared to healthy controls. we also found a great presence of leukocyte derived levs (lmvs) in als patients compared to ad patients and healthy donors and significant correlation with the progression rate of the disease. on the other hand, mirna and rna whole transcriptome sequencing identified a specific signature of mirnas in plasma derived sevs of als patients compared to a group of healthy controls and three neurological groups of control. summary/conclusion: these data may suggest that levs derived from als patients, enriched in lipids and toxic proteins, might play a role in prion-like propagation and immunity of als disease, while sevs, deriving ps . introduction: dendritic spines are actin-rich structures at the postsynaptic sites of most excitatory synapses in the central nervous system. they are highly important structures for higher brain functions such as learning and memory. several live imaging studies have shown that long, thin, actinrich protrusions called dendritic filopodia are precursors of dendritic spines in hippocampal and cortical neurons. so far, many intracellular factors that regulate filopodia formation have been identified. however, extracellular mechanisms of filopodia formation are largely unknown. also, detailed molecular mechanisms by which astrocyte secreted factors regulate synaptogenesis are not well understood. small extracellular vesicles (sevs)/exosomes have potential to regulate filopodia, spine and synapse formation in autocrine or paracrine manner due to their unique cargo composition. here, we examine role of exosomes in filopodia, spine and synapse formation. methods: primary rat hippocampal and cortical neurons were transiently transfected with the multivesicular body (mvb) docking regulator gfp-rab b or with shrnas against the exosome secretion and biogenesis regulators rab b and hrs. transfected neurons were immunostained for synaptic proteins and analysed for filopodia at day in vitro (div) or spines at div . for rescue experiments, exosomes were isolated using differential ultracentrifugation method from conditioned media of div cortical neurons or primary astrocytes and characterized for their size, common protein markers and morphology. results: here, we find that mvb docking factor gfp-rab b localizes to both the tips and bases of actin-rich filopodia and spines in primary neurons. furthermore, genetic regulation of exosome secretion by overexpression or knockdown of rab b or hrs leads to respective increases or decreases in the number of filopodia, spines and synapses. the defects of exosome-inhibited neurons in filopodia density are rescued by add-back of neuronal exosomes. additionally, treatment of primary neurons with exosomes isolated from primary astrocyte cultures leads to enhanced spine and synapse formation. summary/conclusion: these results indicate that autocrine and paracrine communication via exosomes are a key part of the process of neuronal filopodia, spine and synapse formation. effects of apolipoprotein e genotype on protein and small rna profiles of brain tissue-derived extracellular vesicles of alzheimer's disease patients introduction: multiple sclerosis (ms) is the most frequent chronic inflammatory disease of the young adult central nervous system. nevertheless, the pathogenesis remains largely unknown. it is therefore relevant to better characterise in cerebrospinal fluid (csf), which irrigates the brain, novel bioactive compounds whose dysregulation could be involved in ms pathology. the concentration of extracellular vesicles (evs) has been already found affected in ms patient fluids but the content in bioactive molecules, particularly the micrornas (mirnas), remains barely investigated. the mirna are short oligonucleotides that are major posttranscriptional regulators and we previously showed the dysregulation of specific mirnas in csf of ms patients. evs can potentiate mirna effects by allowing remote action through the shuttling within biological fluids such as csf while providing a protection from circulating rnase. nevertheless, csf remains a challenging fluid to analyse due to limited access, low volume and presence of lipoproteins (other putative mirna carrier) that can be co-isolated with evs. methods: we performed a comparative analysis of ev isolation from csf by size-exclusion chromatography (sec), density-gradient ultracentrifugation, ultrafiltration or chemical precipitation (chemp) to determine the optimal technique(s) to enrich ev. results: sec applied on csf of control patients showed optimal ev purification with sufficient evs from . ml of csf for downstream ev characterization. furthermore, we were able to isolate mirnas from csf and determined their enrichment in evs by rnase-sensitivity treatments. finally, we have combined chemp and sec to enable a fast and largescale isolation of evs from > ml of csf, which successfully provided an increase in particles detected by nanoparticle tracking analysis. we are currently characterising the particles to confirm that they are purified evs, cleared from contaminants. summary/conclusion: this work opens perspective to analyse evs from ms patients and to determine whether mirnas participates in ms pathogenesis through their transit in evs. funding: fondation louvain, charcot foundation. differences in circulating number of extracellular vesicles between contact sport athletes with and without acute mtbi: a pilot study meghan rath a , jacqueline sayoc a , soo-young choi a , karlee burns b , aja corchado c , jane mcdevitt b , jingwie wu d , ryan tierney b , michael selzer e , xiaoxuan fan f and joon-young park a for bottom-up guc, increasing iodixanol gradients with . ml of samples were centrifuged at k g for h. fractions were then pooled based on densities ( . - . g/ml). bca and sds-page were used to analyse total protein; nanoparticle tracking (nta) and transmission electron microscopy (tem) for ev presence; and immunoblotting and imaging flow cytometry (ifcm) to evaluate ev specific markers. (ev-track id: ev ). results: immunoblotting showed absence of actinin from all samples, while cd and tsg were detected for all samples; apart from imf_ip. nt_samples were not analysed reliably by nta and ifcm, due to the high concentration of casein micelles present (~ ^ /ml in milk) that otherwise would be co-counted with evs. as expected, following ip, which most efficiently removed casein micelles, bca showed that samples had lowest total protein. this was confirmed by sds-page. thus, most effects were then focused on the ip casein-depleted samples. ifcm indicated that, post-guc, sm_ip evs had significantly (p < . ) more cd -positive particles/ml of milk vs all other guc and kduc samples. while there were no significant differences in sizes of ev separated from sm or imf, directly comparing the ip pre-treated samples, sm had significantly (p < . ) higher quantities of evs when compared to imf. additionally, tem indicated that evs separated from sm by guc were intact with limited background debris, whereas those separated from sm by duc and all imf evs were not. summary/conclusion: in conclusion, regardless of the method used, imf has fewer intact evs compared to sm. also, to obtain purest sm evs, ip followed by guc separation is optimal. introduction: extracellular vesicles (evs) exist as subpopulations with heterogeneous content. the surface heterogeneity of evs may reflect differences in functionality between ev subpopulations, as interactions with recipient cells may differ between ev subpopulations with different surface profiles. however, it is currently challenging to study functional differences between ev subpopulations due to the lack of suitable techniques to purify intact evs based on their surface signature. here, we showcase a novel capture-and-release platform to enrich intact ev subpopulations by their surface profile and compare their characteristics. methods: mda-mb- and skov- cell-derived evs were isolated using size exclusion chromatography. ev subpopulations were enriched based on surface markers cd , cd , cd or phosphatidylserine (ps) using a novel magnetic bead-based capture-and-release platform. obtained evs were characterized by transmission electron microscopy (tem), nanoparticle tracking analysis (nta) and western blotting. evs were fluorescently labelled using pkh and celltracker deep red (ctdr) and their uptake by recipient cells was examined using flow cytometry. results: western blot analysis showed that ev subpopulations enriched for the selected tetraspanins and ps were successfully isolated using a novel capture-andrelease platform. interestingly, evs isolated based on ps exposure (ps+) lacked most canonical ev markers. all ev subpopulations showed intact, cup-shaped morphology when analysed by tem, but contained less protein contaminants compared to the initial ev isolate. ps+ evs were slightly larger than other ev subpopulations when analysed by tem and nta. to test the capacity of ev subpopulations to interact with recipient cells, evs were labelled with pkh and ctdr prior to subpopulation fractionation. after fractionation, ps+ evs showed a significantly higher ctdr/pkh ratio than other ev subpopulations as determined by fluorescence spectroscopy, suggesting higher esterase activity of ps+ evs compared to other tested subpopulations. furthermore, mda-mb- derived evs isolated based on cd and cd expression were taken up more efficiently by hmec- and mda-mb- cells than evs isolated based on presence of cd or ps. summary/conclusion: using a novel technology to isolate ev subpopulations based on their surface profile, we here show that composition and cellular uptake efficiency differs between ev subpopulations. theoretically, this technology is applicable to any surface marker of interest, allowing its use to further establish ev surface-functionality relationships and enrich evs with desirable characteristics for therapeutic purposes. funding: this work was supported by a veni grant (no. ) of the dutch research council (nwo). aml were harvested from tib cells cultured in evfree medium using serial ultracentrifugation. hspc (ksl; lin-sca + ckit+) clonogenicity and inflammatory responses were assessed using colony-forming unit (cfu) assay and real-time polymerase-chain reaction, respectively. ifn-alpha receptor (ifnar ) expression and intracellular reactive oxygen species (ros) levels were assessed by flow cytometry. dna damage were assessed by quantifying nuclear γ-h ax using immunofluorescent microscopy. results: similar to evs derived from aml patients, tib ev-aml elicited double-stranded breaks in hspcs, and actively suppressed hspc clonogenicity. transcriptional profiling revealed that exposure to ev-aml induced the upregulation of several inflammatory mediators in hspcs, including isg , il- , ifnα, ch h. inflammatory signalling triggered by ev-aml did not depend on ifnα signalling as evident from suppression of clonogenicity in ifnar -null hspcs as well as the lack of evs-induced stat phosphorylation or ifnar downregulation. instead, we found increased levels of ros following ev-aml exposure. summary/conclusion: our findings support a model whereby ev-aml inflammatory signalling and oxidative stress lead to dna damage in hspcs. introduction: basic leucine zipper atf-like transcription factor (batf ) is implicated in inflammatory response and anti-tumour effects. although the tumour suppressive function of batf has been reported, its extracellular role in maintaining a non-supportive cancer microenvironment has not been explored. methods: in this study, we established gbm orthotopic and subcutaneous tumour models in nude and balb/c mice and flow cytometry analysis determined the batf inhibitory effects of mdscs recruiting. we used transwell assay to determine batf -positive evs (evs-batf ) inhibitory of the chemotaxis of myeloid-derived suppressor cells (mdscs) in vitro. in addition, exo-counter detection during the development of the gbm-batf model to demonstrate evs-batf crosstalk with distant tissues. amd blocking in tumour model confirms that evs-batf dominated by the sdf- a/cxcr signalling pathway. in addition, exo-counter detection of evs in pairs of gliomas in different stages proposes plasma-evsbatf (plevs-batf ) as a prognostic marker. results: we found that tumour-derived evs-batf regulate crosstalk between glioma cells and tumour microenvironment by inhibiting mdscs recruitment. evs-batf can be detected in plasma and bone marrow of glioma-bearing mice, this provides direct evidence that glioma-derived evs can communicate with distant site by crossing blood-brain barrier. besides, evs-batf injection significantly reduced sdf- α expression in the tumour tissues. after blocking sdf- α signalling by amd , the inhibitory effects of batf overexpression on mdscs recruitment were rescued. evs-batf inhibit mdscs recruiting and secreting mmp , mmp , and vegfa which promote gbm progression. strikingly, exo-counter detection of evs in pairs of gliomas in different stages reveals that the number of plevs-batf can distinguish stage iii-iv glioma from stage i-ii glioma and healthy donors. summary/conclusion: our results suggest that evs-batf may be an effective circulating biomarker associated with glioma progression. of note, we are the first to determine the regulatory role of evs-batf in regulating tumour microenvironment and propose plevs-batf as a prognostic marker predicting glioma progression and candidate target for gbm therapy. introduction: electrofluidics is an emerging technology of combining electronics and nanofluidics. one important device in electrofluidics is an ion transistor in which the ionic current through a nanopore is regulated by gate voltage bias. here, we suggest a fabrication method of nanopore by introducing focused ion beam (fib) and atomic layer deposition (ald) to sense extracellular vesicle (ev) via metal electrode structures. methods: we deposited nm-thick silicon-nitrite layers on both sides of silicon wafer by low-pressure chemical vapour deposition (lpcvd). we fabricated rectangular patterns by photolithography followed by reactive ion etching (rie) on the backside of the wafer. anisotropic silicon etching by koh was performed. the front side of the chip was patterned by photolithography followed by ti/au deposition for the fabrication of electrode structures. we drilled ~ nm pores in the si n membrane by fib. by the ald process, we deposited highly-conformal metal film, either platinum (pt) or ruthenium (ru) to shrink nanopores by a self limiting process. results: we expect that the ion current through the nanopore is efficiently controlled by the gate-surrounding structures. the nanopore ion transistor can be used to count the number of evs. summary/conclusion: we suggest a fabrication method of nanopore ion transistors by introducing focused ion beam (fib) and atomic layer deposition (ald). this device will be applicable for single ev sensing. introduction: extracellular vesicles (evs) are key players in cell-cell communication and increasing evidence has shown that evs function in cancer by promoting cancer cell motility and metastasis. analysing tumour-derived evs in biofluids is attractive because it would be a novel approach to a non-invasive liquid biopsy. unfortunately, evs are highly heterogeneous. they vary greatly in size, lipid composition, and cargo and are difficult to distinguish from other small particles in complex biofluids. we have developed a novel flow cytometry method to generate a distinct ev fingerprint to profile biological specimens. methods: evs from cell culture media (purified and unpurified) and biological fluids (plasma and urine) were detected by flow cytometry using features on individual evs produced by intrinsic (cd -phluorin) and extrinsic (lipophilic dye, di- -anepps, and antibodies) fluorescent labels. ev subpopulations were visualized with dimensional reduction (t-sne and umap) of - features that defined the vesicle size, shape, and fluorescent emission spectra associated with the fluorescent marker. unsupervised density based clustering (hdbscan) in conjunction with supervised machine learning (xgboost) was subsequently used to define subpopulations. we refer to this method as "ev fingerprinting". results: ev fingerprinting was successfully used to detect evs in complex biological specimens and trace their differential enrichment through conventional purification methods. evs were readily distinguished from protein complexes, lipoproteins and non-lipid particles. calibration with externally validated purified ev, as well as size, lipid, and fluorescence standards enabled ev fingerprinting as a rigorous and reproducible method for resolving heterogenous ev samples. ev fingerprinting applied to conditioned medium from tumour cells and biological fluids from cancer patients reveals unique ev profiles generated by cancer, further supporting the potential of ev fingerprinting as a liquid biopsy. summary/conclusion: our single-ev analysis approach characterizes whole ev populations in complex biological fluids without the need for purification, reducing time intensive purification protocols and subsequent sample loss, permitting efficient analysis of liquid biopsy samples. detection and quantification of extracellular vesicles with cargo protein and rna using the amnis® cellstream® flow cytometer introduction: the particle size distribution (psd) of extracellular vesicles (evs) is commonly measured by tunable resistive pulse sensing (trps) and nanoparticle tracking analysis (nta). both trps and nta have limitations that hamper the accurate measurement of the psd of evs, specifically in the size range from to nm. an alternative technique for measuring the psd of evs is micro-fluidic resistive pulse sensing (mrps). because a standard operating procedure (sop) for characterizing evs by mrps is absent, we aim to establish a reliable sop to ensure reproducible psd measurements of evs by mrps. methods: measurements (n = ) of red-blood cell, prostate cancer cell line supernatant, and human urine and plasma evs were acquired in × s acquisitions. two microfluidic cartridges were used to study a dynamic range of - nm. samples were diluted into phosphate buffered saline with different concentrations of tween or bsa. because the excess of particles affects the detection limit, serial dilutions were performed to find the optimal dilution for each sample. data were evaluated using data viewer software. results: the optimal dilution was determined for each sample by maximizing the particle rate and minimizing the measurement time while preserving a robust detection limit of or nm. moreover, we developed a procedure to optimize the peak filter settings of data viewer by fitting data to normal distributions and identifying threshold values for signal-to-noise ratio, symmetry, and transit time within % confidence. summary/conclusion: we recommend to use . % w/ v bsa in dpbs as sample diluent, because tween affects evs as confirmed by flow cytometry. by using orthogonal techniques and well-characterized biological test samples, we developed and validated a sop for ev detection by mrps, thereby making mrps a valuable tool for ev researchers. real-time measurements of extracellular vesicles binding kinetics achieved through interferometric imaging in a multiplexed microarray modality introduction: extracellular vesicles are very promising diagnostic biomarkers. as a matter of fact, the properties of these biological nanoparticles depend on the health conditions of each individual. however, experiments that involve evs phenotyping are time consuming, due to h-or overnight incubations. in order to get accurate results, maximizing binding efficiency is a necessity; that normally involves ensuring the saturation of the capture reaction, which can result in an unnecessarily long incubation time. with the ability of labelfree kinetic binding measurements using interferometric reflectance sensing in a microfluidic chamber, we perform an optimization of the incubation time in different flow conditions, while demonstrating a new way of multiplexing for real-time evs specific capture and detection.methods: all the real-time binding measurements were performed with the interferometric reflectance imaging sensor (iris). iris chips were first coated with an organic polymer (mcp- ), which provides an active surface for probe immobilization. then, antibodies against cd , cd , cd markers were spotted at different densities in a microarray modality. the chips were then encapsulated with a glass window to form a microfluidic chamber that allows for imaging the sensor surface. samples of hek-derived extracellular vesicles were flowed across the sensor surface in the iris system and real-time images were acquired. incubation was performed at different flow rates, and in static and stopflow modalities. results: in this work, we focus on the specific capture of evs under different flow conditions to achieve an optimization of the incubation time. indeed, through the acquisition of real time binding data, we are able to precisely monitor the equilibrium point of the capture reaction. in this configuration of iris, low magnification optics allow for simultaneous detection of binding on hundreds of capture ligand spots. therefore, surface probes (surface density and specificity) as well as assay conditions can be optimized. we report on the optimization of antibodies against cd , cd , and cd markers. since the sensor chips are identical to the single-particle detection assays developed by nanoview biosciences, the optimization of binding assays will directly impact the phenotyping of individual exosomes. summary/conclusion: our method proved to be very efficient in optimizing the most crucial aspects concerning evs captureflow conditions, incubation time, surface density and sample concentration. introduction: diabetes is a life treating diseases extending its impairing influence on more than billion of people around the world within upcoming years. the most harmful complication generating high treatment and social costs is diabetic nephropathy, which develops in about % of patients suffering diabetes. still we do not have an effective and direct prognostic biomarker to diagnose renal complications in the primary stage of renal disease. methods: extracellular vesicles were concentrated from diabetic patients' urine and washed to perform spectral analysis: fourier transform infrared spectroscopy (ftir), based on the molecular absorption of electromagnetic radiation in the infrared region of the spectrum in a range from cm- to cm- and raman spectroscopy (rs) as a technique based on inelastic scattering of monochromatic light. both techniques provide information on the chemical structure of compounds by identifying functional groups with high molecular specificity. results: average spectral signature obtained for evs from urine samples of patients in the different stage of kidney damage allowed distinguishing specific bands, representative for amide (i/ii), lipids, cholesterol and nucleic acids. spectral parameters correlated with a clinical stage and a commonly used indicator of renal function (creatinine) in diabetic patients. summary/conclusion: infrared and raman spectroscopy are promising tools to diagnose and monitor renal function in diabetes. introduction: several existing bioanalytical strategies for purifying and characterizing exosomes have allowed for fundamental progress to be made. mixtures of evs can be enriched for exosomes by techniques such as ultracentrifugation and size-exclusion chromatography. but, these processes require large amounts of material that are often difficult to obtain and many different types of particles have similar sizes and densities. it is likely that unique subfractions within enriched samples exist, particularly in complex biological matrices such as blood, urine or milk which remain difficult to characterize and isolate with existing analytical technologies. methods: bovine milk exosomes were isolated via differential ultracentrifugation and resolubilized in mm ammonium acetate. these data were recorded using charge detection mass spectrometry (cdms). in cdms, individual particles are reflected back and forth through an electrostatic ion trap where they pass through a sensitive charge detector. each time a trapped particle enters and exits the detector, its charge (z) and mass-to-charge (m/z) ratio is measured. mass distributions are generated by multiplying the m/z values by the charge measured for each ion and binning the resulting masses.results: the masses of particles in a bovine milk extracellular vesicle (ev) preparation enriched for exosomes were directly determined for the first time by cdms. particle masses and charges span a wide range from m~ to~ mda and z~ to~ e and are highly dependent upon the conditions used to extract and isolate the evs. in total, , particles were detected from eight cdms measurements. a simple two-dimensional gaussian model suggests that eight unique subpopulations of particles may be resolvable based on charge and mass. complementary em and proteomics analyses confirm that samples are enriched for exosomes. particles associated with the s , s , and s families that are centred at~ . ,~ . , and~ . mda, respectively, appear too small to be ascribed to exosomes. the remaining , ( %) particles detected by cdms are within the mass range expected for exosomes. while cdms measurements are at an early stage of development, this approach appears to provide a new physical basis for separating and characterizing ev particles. summary/conclusion: this work describes a novel biophysical approach for measuring and characterizing the masses and charges of the extremely heterogenous population of exosomes and other extracellular particles enriched in bovine milk. as new sample preparation methods, aimed at purifying specific types of exosomes from different cell lines, tissues, and other body fluids continue to evolve, rapid and sensitive cdms measurements of the physical properties of mass and charge may become an important means of assessing the efficacy of different protocols. funding: nih (r gm - ). bab is supported by indiana university quantitative chemical biology fellowship (t gm ). in situ detection of exosomal microrna- b by fusion with liposomeencapsulated nanomotor introduction: breast cancer is the most common cause of cancer-associated death in women and has raised global health concerns. early diagnosis and treatment are crucial to improve the prognosis and survival rate of breast cancer patients. liquid biopsy is expected to provide a strategy for early diagnosis of breast cancer. exosomes have been regarded as novel liquid biopsy biomarkers due to their stable cargo of rnas, lipids, and proteins from their origin cells. exosomal micro (mi)rnas have recently been recognized as promising indicators of cancer occurrence and progression. however, most of the reported exosomal mirna detection methods require the lysis or extraction process, which increases the possibility of sample loss. in situ detection strategies avoid interference from body fluid. in this study, we developed a gold nanomotor fluorescence platform based on liposome fusion for breast cancer exosomal mirna in situ detection. the exosomal mirna detection platform was constructed using a gold nanomotor (detector) and liposomes (carrier). the dnazyme amplification sequences which could be especially triggered by mirna- b were identified by sds-page before modified on gold nano-motor and the capacity of the nanomotor was assessed using synthetic target sequence, breast cancer cell mda-mb- , mirna- b-encapsulated anionic liposomes, and mirna- b-expressing exosomes. three kinds of liposomes were synthesized, characterized, and assessed for loading ability. membrane fusion effect was evaluated by confocal laser scanning microscopy (clsm) and nanoflow cytometry. the performance of this method to discriminate between breast cancer patients and healthy individuals was investigated. results: the chosen dnazyme amplification sequences transformed "locked" status to "cleavable" status on target addition, releasing a fluorescence signal. the modified gold nanomotor showed a ten times higher fluorescence signal in the presence of mirna- b than the background and no noticeable fluorescence changes from a single-base-mismatch sequence. moreover, among the three different liposomes, cationic liposomes exhibited great stability, high loading efficiency, and excellent membrane fusion effect. furthermore, the fluorescent experiments confirmed that cationic liposomes could load and transfer the nanomotors into exosomes for mirna- b detection. finally, we were able to distinguish breast cancer patients and healthy individuals by sensing exosomal mirna- b directly from plasma samples without exosome isolation. summary/conclusion: a separation-free and sensitive assay based on dnazyme amplification technique and membrane fusion effect was established for breast cancer-derived exosomal mirna- b detection, which could be a promising tool for the liquid biopsy of breast cancer. isolation of exosomes by membrane affinity column increases non-exosomal rna recovery in comparison to differential ultracentrifugation introduction: exosome-based liquid biopsy is a potential aid in the diagnosis and prognosis of cancer patients. however, in order to incorporate exosomes into clinical routine, there is a need to compare different isolation methods. here we analysed the impact, in exosomal rna yield, of two intermediate recovery/ intermediate specificity methods: differential ultracentrifugation (ucd) and a membrane-affinity column (mac) kit. although mac has a faster performance which is more suitable to the clinic, we found that ucd results in a higher recovery of exosomes and less contaminating non-exosomal rna.methods: exosomes were enriched by mac and ucd from identical volumes of human plasma ( , xg, min/ . ) m filtration/ , xg, h)(n = ) and lymphoma conditioned medium( xg, min/ xg, min/ xg, min/ , xg . h/ , xg, h) (n = ). all exosomes were characterized by nanoparticle tracking analysis (nta), immunoblotting of cd /cd /flotilin/alix and electron microscopy (tem). exosome pellets were pre-treated with proteinase k ( mg/ml/ °c/ min) and rnase a ( mg/ ml/ °c/ min) before phenol-chloroform/glycogen rna extraction. rna yield was measured by both fluorometer and bioanalyzer.results: isolation of exosomes by ucd, in both plasma and medium, resulted in a higher yield in comparison to mac. this was shown by an augmented intensity of marker bands in the ucd samples (p = . , n = ) as well as by an increased number of exosomes in tem.in contrast, mac final exosomal fraction (from both plasma and medium), resulted in a -fold and fold increase in rna, respectively, in comparison to ucd when measured by fluorometer. this was confirmed by bioanalyzer. introduction: there is a need for better techniques for characterizing ev populations. we developed a sensitive multiplexed electrochemiluminescence (ecl)based assay format to characterize evs in cell-conditioned medium (ccm) and human biofluids. here we use the format to analyse ev samples for the presence of ev surface proteins, and to identify changes in ev phenotype associated with different cell lines, purification methods and growth conditions. methods: multiplex plates were prepared on msd's u-plex® platform with antibodies for putative evsurface proteins. each well displayed an array of nine specific capture antibodies and a negative control antibody. evs from samples were captured on the arrays and then detected with a cocktail of anti-tetraspanin antibodies (cd , cd and cd ) conjugated to an ecl label. three distinct cell types were grown at two sites, msd and atcc. resulting ccm were each purified by four common methods: tangential flow filtration, peg-based precipitation, size-exclusion chromatography and centrifugal ultrafiltration. all samples were also assayed without purification.results: fifty-five of the surface markers were detected on intact evs from at least one evaluated cell type. datasets were analysed using correlation matrices, hierarchical clustering, and machine learning. for each cell type, when comparing unpurified ccm grown at different sites or evs prepared by different purification methods, we typically observed correlations above . , indicating that the purification methods did not introduce bias to ev phenotypes, and that the assay format can provide robust phenotypic information without any purification of evs. two unsupervised clustering analyseshierarchical clustering and t-distributed stochastic neighbour embeddingboth generated wellseparated clusters for each of the cell types, regardless of purification method or source. summary/conclusion: we developed multiplex ev surface marker assays and demonstrated their use for multimarker ev phenotyping. this flexible format enables rapid assay development for new ev subpopulations with or without sample purification. these results also demonstrate ev surface marker phenotyping via multiplex ecl assays may be used to distinguish ev populations from various cell types, and characterize bias introduced by purification. detection of misev recommended ev protein-markers using automated western blotting method for isolation of evs and a simple western blotting platform for automated protein separation and immunodetection of misev-recommended proteins.methods: total evs were isolated by affinity-membrane spin columns from pre-filtered . - ml plasma or - ml urine, respectively. intact vesicles were eluted and the ev-depleted biofluid fraction was collected from the flow-through. a small fraction ( μl) was analysed by a simple western blot workflow providing automated capillary electrophoresis-based protein separation and immunodetection, characterizing each fraction for presence or absence of misevrecommended proteins.results: a range of specific antibodies were identified and the ev fractions were shown to be enriched in evproteins, whereas contaminating non-ev proteins were significantly reduced. isolation of evs was necessary to allow detection of the low abundant ev protein markers, whereas non-ev proteins were readily detectable both in the neat biofluids and in the ev-depleted flowthrough. we characterized the effect of washing on the purity of ev isolates and defined the dynamic range of the workflow using titrations of input volume of both plasma and urine ev isolations. summary/conclusion: simple western blotting protocols were established for quality control of isolated evs in accordance with misev-guidelines. evs isolated using affinity-membrane spin columns were shown to be enriched in ev markers and depleted for non-ev proteins. al-pha beads: a library of extracellular vesicle-associated metalloproteinase biosensors (adams) and a disintegrin and metalloproteinase with thrombospondin motifs (adamtss) are highly promising cancer biomarker candidates that have complex roles in cancer pathogenesis and metastasis. importantly, within the context of lung cancer, the detection of adam proteolytic activity might be more informative than the level of adam protein.therefore, the development of low-cost metalloproteinase biosensors could serve as useful biomarker research tools. methods: to this end, we developed advanced proteolytic detector polyhydroxyalkanoates (al-pha) beadsa library of biodegradable, biopolymer-based protease biosensors. broadly, these biosensors utilise phac-reporter fusion proteins that are bound to microbially manufactured bioplastic beads. these phac-fusions also incorporate specific protease cleavage sites. in the presence of a specific protease, reporter proteins are cleaved off of the al-pha beadsresulting in a loss of bead fluorescence that can be measured using flow cytometry. these biosensors were assayed using either metalloproteinases, conditioned media or evs from in vitro cancer models.results: human metalloproteinase recognition motifs were identified in the literature and a total of different al-pha bead biosensors were designed. a control, tev-specific biosensor detected . introduction: brain extracellular vesicles (evs) are heterogenous and include previously described microvesicles and exosomes. herein we characterized a formerly unappreciated population of mitochondriaderived evs that we term "mitovesicles". mitochondrial dysfunction is a well-established hallmark of ageing and neurodegenerative disorders as down syndrome (ds). hence, we examined mitovesicle levels and cargo under these conditions to characterize in vivo mitovesicle biology and responsiveness to mitochondrial stressors. methods: employing a high-resolution density gradient, distinct and novel populations of evs were isolated from murine and human ds and diploid control postmortem brains or from cell media. morphometric ev features were analysed by nanoparticle tracking analysis and cryogenic electron microscopy, while ev constituents were characterized by western blotting, mass spectrometry, lipid profiling and mitochondrial rna qpcr.results: we identified a population of double-membrane, electron-dense brain evs containing multiple mitochondrial markers ("mitovesicles") that are highly distinct from microvesicles and exosomes. proteomic data show that mitovesicles contain a unique subset of mitochondrial proteins while lacking others, such as tom . mitovesicles have a lipid composition that is unlike that of previously described evs and is consistent with mitochondrial origin. functionally, the complex-iii inhibitor antimycin-a stimulated in vitro mitovesicle release into the cell media, suggesting an interrelationship between mitochondrial dysfunction and mitovesicle biology. in mouse brains, mitovesicle levels increased with age and were found to be higher in ds compared to diploid controls. mitochondrial rna and protein levels were also altered in ds compared to diploid controls. summary/conclusion: we describe a previously unidentified type of metabolically competent evs of mitochondrial origin that we designate mitovesicles. our data demonstrate that brain mitovesicle levels and cargo are tightly regulated in normal conditions and are modified during pathophysiological processes in which mitochondrial dysfunction occurs, suggesting that mitovesicles are a previously unrecognized player in mitochondria quality control and may have a role in the trans-cellular tissue response to oxidative stress. introduction: alzheimer's disease (ad) is a devastating neurodegenerative disease leading to progressive memory loss and ultimately death with limited therapeutic options. growing evidence supports the theory that toxic proteins, like tau and amyloid, may propagate from diseased cells by packaging toxic proteins into extracellular vesicles (evs) and releasing them to infect other cells. one enzyme involved in the isev abstract book biogenesis of evs is neutral sphingomyelinase (nsmase ), which catalyzes the hydrolysis of sphingomyelin to produce phosphorylcholine and ceramide. several groups have reported improved cognition and reduced tau propagation when nsmase is pharmacologically inhibited or genetically knocked down in ad mouse models. unfortunately, current nsmase inhibitors are not suitable for clinical development due to poor solubility and inadequate pharmacokinetic profiles.methods: our group carried out a high-throughput screening campaign followed by extensive medicinal chemistry efforts leading to the discovery of phenyl (r)-( -( -( , -dimethoxyphenyl)- , -dimethylimidazo [ , -b] pyridazin- -yl) pyrrolidin- -yl) carbamate (pddc), an orally active, nm potent inhibitor with excellent selectivity and brain penetration. we tested pddc's ability to inhibit exosome release in cultured primary glial cells as well as an in vivo model of acute ev release. we then treated xfad mice with mg/ kg of pddc daily for six months and monitored their behaviour in the fear conditioning assay.results: pddc dose dependently reduced ev release from cultured primary glial cells and significantly reduced plasma ev numbers in an in vivo model. following chronic treatment with pddc, xfad mice demonstrated significantly improved cognitive function in the fear conditioning assay. summary/conclusion: these promising findings are currently being expanded using mouse models of tau propagation. if successful, these data would support pddc as a novel compound for targeting the pathological spread of tau as a therapeutic for ad. profiling evs in the anterior cingulate cortex of individuals with major depressive disorder introduction: major depressive disorder (mdd) is one of the leading causes of disability worldwide, affecting % of the population. the environment has been thought to play a role in the disease development, resulting in biological changes mediated by epigenetic mechanisms. microrna's (mirna) are well known epigenetic regulators that are disrupted in the depressed brain, and they are packaged into extracellular vesicles (evs). evs have emerged as means of intercellular communication, a process that is also disrupted in mdd. they are thought to transfer mirna between cells, which can alter gene expression in recipient cells. therefore, we hypothesize that ev cargo is altered in mdd subjects compared to healthy controls (hc). the aim is to extract evs from human postmortem anterior cingulate cortex, a region previously associated with depression, and profile the mirna cargo and compare it between mdd subjects and hc. methods: post-mortem human brain tissue from the anterior cingulate cortex of mdd subjects and hc was mildly dissociated in the presence of collagenase type iii. residual tissue, cells, and large vesicles were eliminated, and evs were isolated using size exclusion chromatography. the quality was assessed by western blots and transmission electron microscopy (tem). rna was extracted and a small-rna library was constructed and sequenced using the illumina platform. differential expression analysis was then performed.results: western blots showed little to no endoplasmic reticulum (calnexin), golgi (bip), or mitochondrial (vdac) contamination, along with enrichment of the exosomal marker cd . tem images showed the typical cup-shaped morphology with sizes mostly between and nm. preliminary sequencing results revealed that mir- a- p, which is predicted to target glutamate receptors, is downregulated in evs from mdd subjects. summary/conclusion: high quality ev extractions can be obtained from post-mortem brain tissue using our method. this will be the first study to profile brainderived ev mirna in the context of depression. future studies will be needed to determine the effect of the different levels of mir- a- p. this could provide novel mechanistic insights into the pathophysiology of mdd and will serve as a starting point to examine the potential role of evs in mdd pathology. methods: we use ifc to characterize evs released by glioma using -ala, fluorescently labelled ev (cfda-se, cd ) and glioma specific (tenascin c and epidermal growth factor receptor viii, egfrviii) markers. furthermore, we characterized evs released by egfrviii positive glioma cells treated with dexamethasone, a steroid commonly used in glioma patients, to determine the effect of steroids on ev release. evs were quantified by ifc and results were confirmed by qpcr for the levels of egfrviii mrna. results: firstly, we optimized protocols to label glioma sevs using fluorescently labelled ev markers (cfda-se, cd ) and tumour specific markers (tenascin c and egfrviii). of the total evs (cfda-se), we demonstrate that % are tenascin c positive, . % are egfrviii positive and . % are -ala positive. there was only a minor overlap (< %) between the sub-populations. finally, we show that dexamethasone treated glioma cells release lower total evs ( . -fold), tumour specific evs ( . -fold; egfrviii), egfrviii mrna compared to mock treated cells. summary/conclusion: we demonstrate the potential of ifc to monitor sevs released by glioma cells exposed to different stimuli. this allows the characterization of ev sub-populations providing a working model to understand the dynamics of tumour evs at a single vesicle level. introduction: extracellular vesicles (ev) released by infective forms of trypanosoma cruzi, the agent of chagas' disease, modulate inflammatory response of macrophages through the activation of toll receptor (tlr ) via mitogen-activated protein kinase pathway. this induces the production of nitric oxide (no) and expression of the cytokines tnf-α, il- and il- , which could explain the inflammation observed in experimental chagas' disease, and eventually in the progression of human disease. evs released by the parasite are heterogeneous and it is unknown which factor, or factors present in the different vesicle populations act during the interaction with host cells.objectives. the goal of the present work was to characterize and isolate the different populations of evs released by t. cruzi and test their effects on macrophages. methods: ev released by trypomastigotes forms of t. cruzi (y strain) were purified by asymmetric flow field-flow fractionation (af ) and characterized by nanoparticles tracking analysis (nta). the different populations of evs were incubated with host human monocytes cells (thp- ) and cytokines production determined by elisa and qpcr. the different ev populations were also incubated with llcmk- epithelial cells and the infection by t. cruzi determined. results: we found two distinct populations of evs. a population with to nm (ev ) and another with to nm (ev ). ev induced more tnf-alpha, il- , ip- and ccl than ev . it was also more effective in promoting t. cruzi infection in epithelial cells. due to unknown reasons, making these systems insufficient for use in drug development and infectivity assays.noroviruses are known to attach to gram-negative enteric bacteria and this facilitates infection in vitro. however, the microbiome-norovirus-host communication link is missing. noroviruses infect immune cells present in lamina propria during acute infection, but bacteria themselves are large enough to cross the mucosal and the tight epithelial barrier which separates gut lumen from lamina propria. we hypothesized that binding of noroviruses to bacteria enhances extracellular vesicles (ev) production. because commensal bacterial evs by themselves do not have any detrimental effects on host cells, we believe using evs in in vitro culture will enhance norovirus infection, thus producing higher titre of viruses for vaccine and anti-viral drug development. methods: attachment assay: purified norovirus was incubated with enterobacter cloacae, lactobacillus acidophilus and bacteroides thethiotaomicron, and grown to produce evs. the attachment was confirmed via qpcr.isolation of evs: clarified media supernatants were subjected to ultracentrifugation at varying speeds and . um filtration. co-purification of norovirus with the evs was checked.ev quantification and characterization: ev total protein content was measured by microbca. the number of vesicles were quantified by nanoparticle tracking analysis. scanning and transmission electron microscopy was performed to check quality of ev preparation and determine if virus was attached to the vesicles. internal ev protein content was evaluated using ms-hplc. the evs were also check for infectivity via tcid assay. results: incubation of noroviruses with commensal bacteria resulted in significant increases in production of evs compared to uninfected controls. murine norovirus (mnv), used as a surrogate, was found to be associated with evs. em analysis determine association of viruses with the bacteria as well as the mvs, while also showing certain surface structural changes in virus attached bacteria compared to mock bacteria. the evs were found to cause infection in naive macrophages. summary/conclusion: changes in ev production and content by bacteria exposed to noroviruses will provide insight into its pathogenesis and possible solutions to the low viral output from hunov culture systems.ps . = op . kylie krohmaly a , claire hoptay b , andrea hahn a and robert freishtat a a children's national hospital, washington, usa; b childrens national hospital, washington, usa introduction: bacteria constitutively produce biologically active extracellular vesicles (evs), which contain rna, dna, and/or proteins. bacteria use these evs for communication with other bacteria and recent research suggests bacterial evs can also affect host cells. given these findings, it is necessary to examine the role of bacterial evs in human disease. current methods of bacterial ev isolation from human specimens cannot distinguish between bacterial species. however, there is utility in examining evs from specific species, as bacterial species and their evs may have unique contributions to human disease. our objective was to isolate circulating evs specifically from escherichia coli (eevs) and haemophilus influenzae (hevs), two known colonizers and pathogens in the gut and airway, respectively. methods: total evs were isolated from the blood of six healthy volunteers via precipitation and size exclusion chromatography. evs were then selected via a novel latex bead-based fluorescent antibody construct targeting species-specific outer membrane proteins. we used flow cytometry to evaluate the isolated evs. results: the constructs were saturated with eevs at an antibody concentration of . µg/ml of plasma, as geometric means ≥ . µg/ml were nearly equal. hevs were detected at µg/ml of plasma, but saturation is yet to be determined. eevs were imaged by a fei talos f x electron microscope and measured between - nm, and hevs were between - nm. both types of evs were spherical. summary/conclusion: using this novel technique, we were able to isolate, detect, and visualize eevs and hevs. this technique enables the study of specific bacterial evs. in the future, ev contents will be assayed. furthermore, this technique will be modified so that specific bacterial evs from body fluids can be used for downstream functional applications. this is the first time that bacterial evs from targeted bacterial species have been detected in blood from healthy humans. introduction: nasopharyngeal carcinoma (npc) is characterized by a large presence of regulatory t cells (tregs) and the production of tumour-derived exosomes with immunosuppressive properties. our team showed that npc-derived exosomes favour the suppressive activity and recruitment of human tregs via ccl chemokine, thus contributing to npc immune escape (mrizak et al., jnci, ) . more recently, our team has shown that npc-exosomes could induce tregs by altering the maturation of dendritic cells (dcs) and promoting tolerogenic dendritic cells (tdcs) (renaud et al., herpas congress ). our main objectives in this study are (i) to define and compare the metabolic status of mature dendritic cells (mdcs), control tdcs and tdcs generated in the presence of npc-exosomes (exocnptdc) and (ii) to evaluate the chemoattractive potential of npc-exosomes on exocnptdcs, and notably to investigate the involvement of ccl in this recruitment. methods: dcs are generated from human monocytes in the presence or absence of npc-exosomes. the maturation status of dcs was evaluated at a phenotypic level by studying the expression of maturation markers using flow cytometry and at a functional level by analysing cytokines secretion using elisa. this cytokine analyse has been performed in both conditions, on treated dcs and during co-culture assays of autologous cd t lymphocytes with treated dcs. in a second step, a mitochondrial metabolic and glycolytic study was performed using the seahorse technology (ocr and ecar measurement). finally, the chemoattractive potential of npc-derived exosomes on the different induced dcs was analysed (i) using boyden chamber chemoattraction assays or real-time videomicroscopy (chemotaxis µslide ibidi) and (ii) using rt-qpcr analysis of the receptor expression of ccl (ccr ).results: npc-exosomes alter dc maturation, which gives rise to tolerogenic dcs that favour the induction of tregs. in addition, the metabolic analysis of dcs seems to put foward a specific metabolic signature of the tdcs induced by npc-exosomes. and finally, chemoattraction assay suggests that npc-exosomes preferentially attract tdcs and exocnptdcs in a ccl dependant manner. summary/conclusion: taken together our results should allow us to characterize the major role of npc tumour exosomes on the maturation and the recruitment of dc and so identify them as anti-tumoural therapeutic targets. cytotoxic t lymphocyte ev that prevents tumour metastasis by collapse of tumoural mesenchymal stroma is classified into exosome, but not microvesicle or apoptotic body.naohiro seo a , junko nakamura a , tsuguhiro kaneda a , takanori ichiki b , asako shimoda c , kazunari akiyoshi c and hiroshi shiku a a mie university graduate school of medicine, mie, japan; b the university of tokyo, bunkyo, japan; c kyoto university, kyoto, japanintroduction: recently, instead of ultracentrifugation, development of new preparation protocol is demanded for research of reliable bioactivity and drug discovery of extracellular vesicles (evs). in this study, we propose a novel method for large scale preparation of highperformance extracellular vesicles focusing on membrane negative charge. methods: murine cytotoxic t lymphocyte (ctl) evs in supernatant were concentrated more than times at over % purity without leaking by kda mwco ultrafiltration, and subjected to ion exchange deae column chromatography after replacing with pbs. after ion exchange, evs were characterized by bca assay, nta assay, cryotem observation, proteome analysis, dna content measurement, mirna microarray analysis, zeta potential measurement, lectin array analysis, and target cell analysis.biomarker detection and analysis and detail strategies for cross-platform analytical validation. methods: we conducted a cross-platform analysis using two commercially available flow cytometers designed for ev detection. scatter resolution, enumeration accuracy and precision were determined across both platforms by analysing submicron silica beads (apogeemix, - nm) of known concentration.we detected large evs, as established by reference size beads, electron microscopy, expression of phosphatidylserine and the presence of integral membrane proteins of cell of origin. we analysed evs isolated from plasma by high-speed centrifugation ( , g) as well performing analysis by direct plasma labelling followed by validation by detergent lysis of vesicular constituents. a clinical operating range was defined which ensures linearity and avoids swarm detection. we observed comparable scatter resolution, enumeration accuracy (error ≤ %) and precision (cv ≤ %) across both platforms used. we defined two ev size gates: a "latex" gate ( to nm polystyrene latex beads), and a "silica" gate ( to nm silica beads) for evs at the lower end of our size range of interest. to improve detection sensitivity, we identified common contributors to signal noise and applied workflow strategies to minimize these. finally, we identified linear ranges which avoid swarm detection, and which ensures reproducible ev counts (cv < %) across both instruments. summary/conclusion: we present an optimised, standardised and cross-platform reproducible working protocol which supports the use of fcm in an ev-based liquid biopsy application. funding: the project is funded by spark oceania and uts innovation commercialisation seed fund scheme to mb. metabolomic profiling of serum and exosomes isolated from head and neck cancer patients after radiotherapy introduction: cancer radiotherapy (rt) induces the response of the whole body that could be detected at the blood level. searching for new molecular signatures which could correlate with treatment response in cancer patients is of particular importance. radiation-induced changes in proteome and transcriptome of serum have been widely described. however, metabolomic changes in serum, exosomes and other classes of small extracellular vesicles (ev) of cancer patients after rt have not been given as much attention. metabolomics of serum and ev of cancer patients could provide a valuable insight into the response of both tumour and whole organism to the treatment. the aim of the study was to compare serum and ev metabolomic profiles in head and neck cancer (hnc) patients before and after rt. methods: serum samples from hnc patients were taken before (a) and after (b) rt. healthy volunteers were used as a control group (c). ev were isolated from ml of serum using size-exclusion chromatography (sec). selected sec fractions were subjected to extraction of metabolites. a mixture of meoh/h o was used for extraction of metabolites from serum and ev samples. samples were analysed by gas chromatography-mass spectrometry (gc-ms).the study protocol adhered to the tenets of the declaration of helsinki and was approved by the bioethical committee of the maria skłodowska-curie national research institute of oncology, branch gliwice, poland (permit nr. do/dgp/ / / / / /g). results: an untargeted gc-ms-based approach allowed the detection of metabolites in serum samples and exosomal small molecules, of which joint. the identified compounds included amino acids, fatty acids, carboxylic acids, sugars, and others. there were metabolites which levels discriminated compared groups (a,b,c) of serum samples and compounds that discriminate the ev isolated from hnc serum before and after rt from hc. summary/conclusion: rt caused significant changes in levels of serum and ev metabolites witch are involved in amino acid metabolism, lipids metabolism, energy metabolism and oxidative stress response. capable of contributing to intercellular communication and metastasis. numerous studies have focused on elucidating their role in cancer progression. we recently showed that sevs isolated from pancreatic cancer cells can function as an initiator in malignant cell transformation. here, using a mass spectrometry (ms)-based proteomics approach, we analysed the differences in the protein cargo of sevs secreted from normal pancreatic and cancer cells to better understand their biological characteristics. methods: sevs were isolated from human pancreatic cancer cell lines (capan- , mia paca- , and panc- ) and normal pancreatic epithelial cells (hpde) using a combined ultrafiltration-ultracentrifugation method coupled with a sucrose density gradient purification. proteomic profiling of sevs was carried out using an lc-ms/ms method. protein identification from resulting ms/ms spectra was conducted using proteome database search software followed by gene ontology (go) enrichment and reactome pathway analysis.results: a total of , unique proteins were identified confidently across the combined samples. the proteins present in all four sev types ( , proteins) consist of general housekeeping proteins. proteins were uniquely found in all cancer sevs but not in the normal hpde sevs. this group contains an enrichment of proteins that function in the endosomal compartment of cells responsible for vesicle formation and secretion and suggest their important role in driving the increased production of sevs from cancer cells relative to normal cells. moreover, this group includes a set of proteins that have been implicated in malignant cell transformation, consistent with our previous work showing that each of the cancer sevs analysed here could initiate malignant transformation of nih/ t cells. conversely, there were proteins uniquely found in normal hpde sevs. this group includes a number of immune response proteins that are not found in any of the pancreatic cancer cell sevs. summary/conclusion: the differences in the proteomes of cancer and normal sevs may be indicative of their varying roles in cell transformation and helpful in delineating the types of evs that are being produced. in addition, these differences point towards their potential value as cancer biomarkers. proteomic profile of tumour-derived exosomes in plasma of melanoma patients introduction: in the past years, extracellular vesicles (evs) have attracted considerable interest due to their ability to provide valuable diagnostic information from liquid biopsies. the high abundance in all bodily fluids and their cargo stability confers evs the potential as a powerful tool to not only obtain novel biomarkers from inaccessible tissues, therapy response and monitoring, but also to reduce infection risks of conventional highly invasive biopsies. virtually all cells continuously release vesicles into the extracellular environment, diverse in size, content and features depending on the biogenesis, origin and function. this heterogeneity adds a layer of complexity when attempting to isolate and characterize tissue-specific vesicles. methods: hence, we aimed to use a immunomagnetic capture approach for prostate-derived evs from cell culture supernatants, with further investigation into human plasma and urine samples. analysis was performed by nanoparticle tracking analysis, western blotting and electron microscopy. additionally, an in-house spotted antibody microarray is in development. here, we intend to detect different ev sub-populations based on their surface markers. results: isolated immunocaptured ev populations based on the classical ev marker cd show an increased signal for the luminal protein tsg . ev populations targeting the tissue-specific marker prostate specific membrane antigen (psma), were found positive for tsg in a lower extent indicating a subpopulation of evs. the microarray uses less than µl of sample (concentrated cell culture supernatant, human plasma, urine) and leads to a faster characterization within h for ev surface marker as compared to western blot. summary/conclusion: immunomagnetic isolation might be a promising approach for liquid biopsy and thereby the microarray could be valuable to identify potential capture targets. the current design for different surface marker from samples simultaneously could be easily extended for sample size and surface profiling allowing for a more economical way to multiplex samples. paving the way for implementing a feasible and reliable technique for assessing urinary extracellular vesicles as biomarkers for bladder cancer in clinical practice introduction: extracellular vesicles (ev) in urine have been proposed as biomarkers for bladder cancer (bc). however, at present there are no standardized methods for ev isolation or urine sampling. our goal was to evaluate the ev isolation performance between different methods, the effect of the sampling time and the importance of urinary creatinine (ucr) normalization. methods: two urine samples of ml were collected from patients with non muscle-invasive bc: one from the first micturition and another from any time of the day. twenty ml were used for ucr measurement and ml were used for ev isolation by either precipitation with polyethylene glycol (peg), concentration by filtration (uf, centricon plus- , k, millipore), sepharose size exclusion column (sec), or combinations of these methods. additionally, the effect of protease inhibitors (pi) and dtt treatment after collection or during processing was analysed. size and number of particles were evaluated by nanosight and the presence of exosomal markers was evaluated by western blot. results: among the methods evaluated, uf + sec showed the best performance retrieving the highest number of particles in the range of - nm, and the highest protein expression of exosomal proteins. uf alone showed the highest concentration of ev, but with a tendency to isolate larger particles. particle concentration was positively correlated with ucr, reflecting the importance of ucr normalization before journal of extracellular vesicles comparing between patients. finally, no differences in the performance according to the time of collection, nor in the use of pi or dtt were observed. summary/conclusion: uf + sec gave the highest ev yield and was not affected by the time of urine collection. the use of pi and dtt can be avoided, and normalization to ucr should be considered when implementing this technique for assessing evs as biomarkers for bc in clinical practice. funding: pida . the introduction: human tumours, including pancreatic ductal adenocarcinoma (pdac), often harbour a subpopulation of cancer cells with extra centrosomes. we found, that these cells secrete an increased number of small extracellular vesicles (sevs), within the - nm size range. sevs play a role in cancer signalling and progression and are widely studied for their diagnostic potential. we aim to understand the role of sevs secreted by cells with extra centrosomes in shaping pdac-associated stroma, particularly fibrosis. methods: to study the sev mediated changes in the pdac microenvironment, we purified sevs through serial ultracentrifugation and size exclusion chromatography, characterised the content through silac-based proteomics, and assessed phenotypic changes in pancreatic stellate cells (pscs) and extracellular matrix (ecm) production through immunofluorescence staining. results: our data indicates, that the sevs secreted by cells with extra centrosomes are exosomes due to their endocytic origin, and we found, that they can activate pscs, key mediators of fibrosis in pdac. indeed, we observed an increased level of collagen i produced by pscs activated by sevs from cells with extra centrosomes as compared to cells without extra centrosomes. interestingly, we found, that psc activation through sevs is not mediated by tgf-β, assessed by the level of nuclear smad accumulation downstream of tgfβ activation, suggesting a novel mechanism of pscs activation. summary/conclusion: pdac cells with extra centrosomes contribute to a novel type of psc reprogramming, which could alter their ecm deposition and contribute to the extensive fibrosis observed in pdac. we are currently characterising the signalling pathways associated with sev mediated psc activation and how it impacts padc progression to better understand the role of centrosome amplification in the cancer-stromal crosstalk. exosomal carboxypeptidase e confers and cpe-shrna loaded exosomes inhibit growth and invasion of hepatocellular carcinoma cells. methods: exosomes were isolated from the culture media of high metastic hcc h cells and incubated with low metastatic hcc l cells. in other experiments, cpe-shna loaded exosomes from hek cells were incubated with hcc h cells. the recipient cells were analysed for proliferation using mtt assay, colony formation, and matrigel invasion. results: analysis of exosomes derived from hcc h cells revealed cpe-wt mrna and protein. exosomes released from hcc h cells were able to enhance proliferation and invasion of hcc l cells. when cpe expression was suppressed in the hcc h cells before exosome isolation, the exosomes had no effect on proliferation and invasion. these data demonstrate the ability of exosomes to confer growth and invasion in hcc cells and the role of exosomal cpe in driving the process.previously it was shown that down-regulation of cpe expression by shrna can reverse tumour growth and metastasis in an hcc mouse model. we therefore loaded cpe-shrna into exosomes by infecting hek (human embryonic kidney) cells with adenovirus carrying cpe-shrna-gfp. these modified isev abstract book exosomes were used to transfer cpe-shrna to hcc h cells, resulting in significant reduction in proliferation and colony-forming ability of these cells. cpe-shrna loaded exosomes were found to down-regulate the expression of cyclin d and c-myc, two genes with high relavance to tumour growth and metastasis. summary/conclusion: our results demonstrate the ability of exosomal cpe to enhance proliferation and invasion in low metastatic hcc cells and the potential to use shrna loaded exosomes to target cpe as a therapeutic strategy to treat liver cancer.funding: intramural program of the eunice kennedy shriver national institute of child health and human development, and national cancer institute, national institutes of health, bethesda, md. . stress hormones promote prostate cancer aggressiveness through modulation of mir- - p expression and exosome release north carolina central university, durham, usa introduction: despite proactive screening and steady declines in mortality, prostate cancer (pca) remains one of the most prevalent cancers among men. evidence suggests that chronic activation of stress signalling pathways can result in an altered mirnas transcriptome and affect exosomal content and release. here, we study the interaction between leptin and mir- - p expression, previously shown to be downregulated in pca patients. in addition, explored the effect of stress hormones cortisol and leptin on exosomal release and content from pca cells.methods: we utilized normal prostate cell line rwpe- , and pca cells pc , lncap and mda-pca- b. proliferation of cells treated with leptin in the presence or absence of mir- - p mimic or negative control was assessed by mtt, colony formation, wound healing, and expression of targets affected by mir- - p was assessed by western blotting. moreover, exosomes were isolated via differential centrifugation from pca cells treated with leptin or cortisol and exosome number was determined by nanotracking analysis. exosome content was determined by western blotting and proteomic analysis by mass spectrometry.results: we observed that leptin significantly decreased expression of mir- - p in rwpe- cells.co-treatment with mir- - p mimic and leptin abrogated these effects in a cell dependent manner. we also observed that co-treatment with leptin affected mir- - p target jag and other molecules involved in epithelial to mesenchymal transition. in parallel, we demonstrated that cortisol increases exosome secretion particularly in pc cell exosomes with a . -fold increase at nm cortisol compared to untreated. western blotting revealed the presence of gr in exosomes particularly at nm cortisol. summary/conclusion: understanding epigenetic regulation through mirnas and exosomes may be the key to understand stress hormone influence in pca progression. these findings suggest that stress hormones effectively affect mir- - p expression and exosomal release and signalling.introduction: extracellular vesicles (evs) are promising drug delivery vehicles for therapeutic microrna (mirna). for the loading of exogenous cargo, researchers broadly seek to either manipulate the evs directly or the cell that produce them. electroporation, sonication, and direct ev transfection are common methods that work by physical disruption or irreversible chemical addition, which may irreparably damage the molecules intended for therapy. on the other hand, transfection into the producer cells is a simple option that does not imperil ev integrity.methods: there are multiple factors that contribute to ev loading efficiency, including transfection reagent used, timing, and dosage. thus, we sought to establish a basic protocol and improve understanding of the underlying dynamics involved in a basic system consisting of hek t cells and mir- a- p mimic.results: in this work, we examined how different reagents lead to variable ev loading. then we looked at variable dosages, specifically the relationship between rna amount added to reagent, amount present in cell, and amount exported to evs. summary/conclusion: these results will help future studies produce evs with exogenously loaded small rna, and suggest future optimizations. funding: national institutes of health. r and t (host pathogen interactions at university of maryland). we report a single ev trapping method via aptamermediated assembly between au nanoparticle (aunp) and au superlattice template. we propose a chip-based ev trapping technique based on semiconductor processes. methods: we introduce aptamer coated au nanoparticle (aunp) and au superlattices as a template to capture evs. first, we fabricated poly(methyl methacrylate) (pmma) hole pattern on au-coated si substrates by using electron beam lithography (ebl). we designed nm-diameter hole patterns to capture one ev in each hole. to connect the aunp and the au superlattice template, we used an aptamer molecule as a linker strand. also, to capture individual evs, the aptamer molecule is designed to have a hairpin structure to specifically bind to cd , a protein marker of ev. we modified ʹ-terminal and ʹ-terminal of the cd aptamer with thiol group for the formation of self-assembly monolayer (sam) on both aunp and au superlattice surface. results: first, we coat the cd aptamer on the surface of aunp. afterwards, we load the aptamer-coated aunp into au superlattice template. ev solution is specifically bound to cd aptamer. after washing step, each ev is expected to locate within a single hole due to the size confinement of the hole. to separate the evs from the aptamer, we use restriction enzyme, bamhi, to recognize specific dna sequence and cleave them. summary/conclusion: in this report, we propose a aunp -linked au superlattice chip by aptamer molecules for trapping evs. we selected cd aptamer for specifically binding with cd in evs. in addition, we designed cd aptamer as a linker strand to connect introduction: a hallmark of platelet activation is the release of internal granules as extracellular vesicles/ microparticles. thrombolux is a dynamic-light-scattering-based (dls) instrument that was developed for use in clinical setting to check for platelet activation before transfusion. compared to traditional dls, the thrombolux requires no cleaning (single-use capillary) and requires very little sample ( µl). hence the thrombolux may be a useful instrument beyond platelet pack test in blood transfusion laboratory. we have evaluated its use as an in-process monitoring tool for industrial ev manufacturing, for both quantifying cells (input) and evs (output). methods: the thrombolux was used to test the activation status of expired platelet packs (donated by arcbs for research purpose). the readout was compared with platelet swirling test and flow cytometry data (surface marker). furthermore, the thrombolux was also tested for process development and ev manufacturing monitoring purposes at different stages of the process for its ability to rapidly obtain particle presence and size information on evs. time to result was also compared between different particle analysis methods. results: the thrombolux was a better predictor of platelet packs variability compared to the traditional platelet swirling method. however, we did not observe a strong correlation between the activation status and the flow cytometry-based activation marker data. the thrombolux was able to provide a useful estimation of particle presence and sizing of evs in-process.results are obtained rapidly, within minutes, with minimal sample prep. summary/conclusion: although we did not observe a significant direct correlation between flow cytometry activation data and the % microparticles (within a small sample size), the thrombolux has shown potential to become a useful tool for in-process monitoring for ev manufacturing and other ev research, in particular through its speed and ease of use. funding: all funding was through exopharm ltd (asx:ex ). secreted introduction: a major manufacturing challenge related to exosome bioprocessing is that of robust and scalable purification. as efforts to translate exosomes into clinics grows, the more important the design of quality systems which can reproducibly purify the product becomes. the current gold-standard, ultracentrifugation, was adopted from the viral vaccine industry, but remains imperfect in terms of scale up and manufacturing due to labour and time intensive process requirements. in order to follow the preferential adoption of more standard bioprocesses, as previously achieved by the viral vaccine industry, we show the development of two monolith chromatography steps which can be used to purify exosomes from a clinically relevant, allogeneic stem cell product (ctx e ). methods: t-flask expansion of ctx e cells was performed to yield batches of - l of conditioned medium. the medium was subsequently clarified by benchtop centrifugation, and concentrated into a crude concentrate by tangential flow filtration [tff], using a combination of . µm dead-end filtration prior to concentration in a kda hollow-fibre tff system. tff retentate was loaded onto ml hic or aex monoliths, for further purification. potency was assessed by a fibroblast wound healing assay in vitro. results: exosome presence was verified in the tff material by detection of cd and cd . exosomes recovered in this manner could achieve full wound closure in vitro over hours, when dosed at µg. further purification by monolith chromatography showed high levels of reduction of albumin, detected by western blot, as well as heightened ratios of particles to both total protein, and total dna. the results indicate that neither aex nor hic steps cause detrimental loss to product function, either alone or in combination with one another. introduction: custom-made platelet pellet lysate (ppl) and heat-treated ppl (hppl) exert strong neuroprotective effects of neurotoxin-exposed dopaminergic luhmes neuronal cell culture. this effect is significantly enhanced using hppl, which was also highly protective of th-expressing neurons in mice parkinson's disease (pd) model. introduction: there is a critical unmet medical need for new therapies to treat age-related diseases including cardiovascular diseases such as stroke. exosome derived from stem cells have shown intrinsic therapeutic potential in a variety of animal models of ischaemic diseases. we have identified scalable exosome production cell lines (purestem) as a source of angiogenic exosomes and are aiming to generate good manufacturing practice (gmp) grade therapeutic exosomes that can effectively mediate angiogenesis and tissue regeneration. we are developing exosome production and purification protocols that combine methods of tangential filtration flow (tff) and size exclusion chromatography (sec). the particle number and size were measured by both tunable resistive pulse sensing (trps) as well as nanoparticle tracking analysis (nta) for comparison. exosomes were characterized by detection of exosome surface markers and absence of cellular markers. purity was assessed by measuring particles per ug of total protein content. the angiogenic activity of purestem-exosomes was assessed using live-cell imaging to measure endothelial wound-healing and tube formation assays. we further investigated the molecular cargo of purestem-exosomes by screening mirnas targets, rna-seq analysis, and mass spectrometry analysis.results: the isolated purestem-exosomes using our developed protocols were highly purified, resulting purity in the range of e - e particles/ug. we selected angiogenic exosome-producing cell lines from our purestem library by screening for functional activity and characterizing their molecular cargo. we found that purestem progenitor-derived exosomes showed higher angiogenic potency than primary mesenchymal stem cell (msc)-derived exosomes. furthermore, angiogenic micrornas such as mir- were enriched in purestem-exosomes from certain producer cell lines. summary/conclusion: these data demonstrate the potential for using purestem lines as a highly scalable source of therapeutic exosomes. we were able to obtain highly pure exosomes that retain their angiogenic activity. we anticipate that purestem-exosomes will be a valuable resource for developing ev therapies for stroke and other ischaemic diseases. we have developed purification methodologies aimed at achieving a robust and scalable exosome production compatible with gmp for clinical grade purestem-exosomes. these developments have great potential as therapeutic agents for future preclinical in animal model of stroke and clinical trials. neuronal introduction: the hallmark of parkinson's disease (pd) is a-synuclein accumulation, predominantly in dopaminergic neurons, causing neurodegeneration. pd is also associated with insulin resistance, a condition characterized by phosphorylated insulin receptor substrate- (irs- ). besides motor symptoms, some pd patients develop mild cognitive impairment (pd-mci) or dementia (pd-d). given the importance for prognosis, there is an urgent need to develop biomarkers for distinguishing pd with normal cognition (pd-n) from pd-mci/d. neuronal-origin extracellular vesicles (nevs) contain cell signalling and pathogenic proteins (including a-synuclein), which may serve as biomarkers for alzheimer's disease, pd and other dementias.methods: from . ml of plasma from pd-n, pd-mci, and pd-d patients, we immunocaptured nevs using anti-l cam antibody. then, irs- pser and irs- ptyr and a-synuclein were measured in nevs using electrochemiluminescence immunoassays.results: a-synuclein was lower in pd-mci and pd-d compared to pd-n (p < . ) and significantly decreased with increasing motor symptom severity measured by mds-updrs iii score (p = . ). irs- pser was lower in pd-d than in pd-n. irs- ptyr significantly decreased with increasing mds-updrs iii score (p < . ). no biomarker was associated with disease duration. summary/conclusion: pd patients with cognitive impairment exhibited lower nev levels of a-synuclein than cognitively intact pd patients, whereas a-synuclein and irs- ptyr were inversely associated with pd motor symptom severity. additional biomarkers and measurements will be available by the time of isev. plasma nevs is a valuable tool for discovering biomarkers in pd and investigating aspects of disease progression. introduction: despite decades-long advancement in transplant medicine, there is a necessity for personalized approach regarding early kidney allograft injury recognition and immunosuppression therapy towards improved transplant outcomes. biopsy, a gold standard for assessment of kidney allograft injury, cannot be serially used for the diagnosis of subclinical injury due to it's invasiveness and possible sampling errors. instead, urine is easily obtainable and bearing extracellular vesicles (evs), potential carriers of pathological signals related to kidney injury. our aim was to set up a urinary ev (uev) isolation protocol that would allow consistent and reliable identification of their characteristics and cargo. methods: second morning urine sample ( ml) was collected from patients and processed within hours. oxalate precipitation, ph and dilution variability, uromodulin polymerization and high protein content were taken into account. isolated evs were defined by transmission electron microscopy (tem) and nanoparticle tracking analysis (nta). uev specific proteins and mirnas were analysed by western blot and qpcr, respectively. results: the optimal protocol relied on low speed urine centrifugation ( . x g, rt) for cell removal and storage at − °c prior to further analyses. after urine thawing at rt, added edta averted cryoprecipitate and uromodulin polymer formation, while concentrated pbs neutralized the ph. filtration through . µm pores was used for large particle removal, while centrifugal kda membrane units (amicon®, milipore) served for sample concentration followed by particle separation on sizeexclusion chromatography (sec; qevoriginal, izon q). protein vacant sec fractions (as rated at a ) were pooled and concentrated to a volume of µl. tem micrographs revealed high sample purity and cup-shaped morphology of uevs. as per nta results, the average mean size of evs was , nm with concentration range of × particles/ml of starting urine. uevs were positive for the tested marker proteins hsc , flotillin, tubulin, gadph and cd . qpcr verified mirna presence in uevs, with ct for mir let- i at . summary/conclusion: we successfully isolated pure uevs. the set up protocol will be used to assess uevs as non-invasive biomarkers of allograft injury in kidney transplant recipients. astrocyte-derived extracellular vesicles regulate dendritic spine formation and neuronal network connectivity introduction: recent advancements in the biology of extracellular vesicles have begun to implicate glial released microvesicles as mediators of glia to neuron communication, suggesting that alterations in the release and/or composition of astrocyte microvesicles could impact neuronal function. methods: astrocytes were allowed to constitutively release extracellular vesicles (adev-cr), or stimulated with atp (adev-atp). adevs were isolated by ultracentrifugation followed by proteomic analysis. we developed a normative whole transcriptome database using primary neurons exposed to adev-cr, and identified changes in neuronal gene expression produced by exposure of neurons to adev-atp. we identified a number of pathways associated with the biological response of synapse, spine and neurite outgrowth that were regulated by adev-atp. the molecular cargo of adev-atp responsible for regulating synaptic functions in neurons were characterized by biochemical, molecular, and functional assays. results: adev-atp enhanced the maturation of dendritic spines and produced functional enhancements in neuronal activity and network connectivity. the mechanism for this effect involved the delivery of integrin- and epha that were enriched in adev-atp. integrin- facilitated binding of adevs to the neuronal surface, and epha -receptor signalled through ephrin to the tyrosine kinase erbb / that regulated the phosphorylation and activation of trkb without increasing expression of the natural ligands bdnf or ntf . this direct activation of trkb increased the expression of the synaptic scaffolding proteins disc , arc, and cplx to promote the maturation of dendritic spines. this increase in mature dendritic spines was associated with increased neuronal activity and network connectivity demonstrating a functional strengthening of synapses. summary/conclusion: these data identify a molecular mechanism whereby modifications in adev protein cargo produced by the stimulation of astrocytes with atp regulates synaptic maturation through activation of trkb in a manner independent of growth factors. stephanie kronstadt and steven m. jay university of maryland, college park, college park, usa introduction: mesenchymal stem cell extracellular vesicles (msc-evs) have been shown to have an immunosuppressive effect in both autoimmune and inflammatory disorders. despite this, clinical translation of ev therapies is hindered by potentially low potency in vivo and the lack of a scalable biomanufacturing process. cell culture parameters are critical in modulating both yield and bioactivity of evs. thus, we hypothesized that the combination of chemical priming and d dynamic culture would enhance the yield and potency of immunosuppressive msc-evs. methods: bone marrow-derived mscs cultured in flasks were chemically primed using ethanol or curcumin. mscs were also cultured using a d-printed scaffold-perfusion bioreactor using a flow rate of ml/min. anti-inflammatory effects were assessed following application of msc-evs to lipopolysaccharide (lps)-stimulated murine macrophages. subsequent inhibition of the production of the pro-inflammatory cytokine il- , quantified using an elisa, was used to characterize evs as anti-inflammatory. in addition, both chemical priming and the bioreactor will be simultaneously utilized to potentially uncover any synergistic effects on ev immunomodulation abilities. nanoparticle tracking analysis (nta) was used to assess ev size and concentration while protein mass was measured via a bca assay. results: preliminary data suggests that priming mscs with µm ethanol for hours prior to ev collection results in a strong inhibition of il- production in stimulated murine macrophages. nta revealed that msc-ev yield increased by about two orders of magnitude in the bioreactor ( . e ± . e ) when compared with flasks ( . e ± . e ). protein measurements also indicated that ev production in the bioreactor (~ µg) was much greater compared with production in the flasks (~ µg). additionally, average protein content per ev was reduced in the bioreactor when compared with flask evs. regardless of tissue source. furthermore, comparison of adipose tissue-derived (ad) msc evs from three donors indicates varying pro-vascularization bioactivity between those donors evaluated in vitro via gap closure assay. similar results were observed for the bone marrow-derived (bm) msc ev donor groups. summary/conclusion: this work highlights the need for screening of donor derived-mscs before use for therapeutic ev production. additionally, standardized criteria for msc donor selection are needed before isolated msc evs can be used as a large-scale, repeatable therapeutic treatment. analysis of extracellular vesicle populations from malaria-infected erythrocytes by field-flow fractionation reveal distinct sub-sets alicia rojas a , paula abou-karam a , anna rivkin a , yael fridmann-sirkis b , yifat ofir-birin c and neta regev-rudzi c a department of biochemical sciences, weizmann institute of sciences, rehovot, israel, rehovot, israel; b wis, rehovot, israel; c weizmann institute of science, rehovot, israel introduction: malaria is one the most devastating infectious disease in the world and plasmodium falciparum (pf) represents the deadliest species. this parasite invades human red blood cells (rbcs) and releases extracellular vesicles (evs) carrying dna, rna and protein cargo components which are involved in the pathogenesis of the disease. recently, it has been shown in mammalian systems that evs are subdivided into different subpopulations, each with a distinct biological function. however, it is still unknown whether pfinfected rbcs (pf-evs) release different ev subpopulations with distinct cargo. methods: we isolated evs from pf-infected and uninfected rbcs, pf-evs or ui-evs, respectively, using differential centrifugation. the ev pellet was subjected to field flow fractionation (fff). the different subpopulations were collected, concentrated with size-exclusion filters and evaluated by nanoparticle tracking analysis. additionally, the presence of ev markers (sr and hsp ) were examined by western blot analysis. results: the fff analysis showed four particle subpopulations derived from the pf-evs and five in the ui-evs. the first three subpopulations were similar in their detection signals in both samples, but the fourth subpopulation was consistently higher in ui-evs than in pf-evs. moreover, hsp was detected in subpopulations and of both pf-evs and ui-evs, whereas sr only in subpopulation . isev abstract book summary/conclusion: pf-ev and ui-ev have similar separation profiles and proteins markers in their subpopulations, consistent with the fact that both samples are derived from host rbcs. additional data regarding the dna and rna cargo, as well as microscopic observations of the pf-ev and ui-ev subpopulations is necessary. this will clarify how malaria parasites sort their components into evs and which fractions are associated to immune evasion and pathogenesis. we have established a small size laboratory production of the microalgae culture in order to harvest the extracellular vesicles (evs) for pharmaceutical and medical uses. in this work we report on globular particles in the isolates from media of microalgae of two types, that we recognize as evs. we observed changes in their production at different temperatures and conditions. methods: samples were fixed by various combinations of aldehyde fixatives and/or osmium tetroxide. they were dehydrated in a graded series of ethanol, hexamethyldisilazane, and air dried. they were au/pd coated for inspection with scanning electron microscopes (sem) crossbeam fib-sem gemini ii (zeiss, germany) and jsm- f field emission scanning electron microscope (jeol ltd., tokyo, japan). results: microalgae were incubated overnight at °c and °c in growth medium and in growth medium supplemented with detergent. the samples obtained from the microalgae culture contained particles that we recognized as extracellular vesicles, however, these particles do not correspond to characteristic shapes of membrane enclosed entities without internal structure. increased temperature and/or presence of surfactant (triton x- and sodium dodecyl sulphate) stimulated formation of evs of different shapes and sizes. the isolates of these samples were rich with evs. in the presence of surfactant, the cell-walls detached from the cell and collapsed upon dehydration. this was documented by sem. summary/conclusion: focused ion beam technique revealed complex internal structure of the algae. it seems from the shapes of the observed structures that the particles deposited on the surface of the microalgae do not derive from budding of the membrane surface, but are instead shed by the cells from the cell interior upon the rupture of the cell wall. key: cord- -tluo ztc authors: strozza, cosmo; pasqualetti, patrizio; egidi, viviana; loreti, claudia; vannetti, federica; macchi, claudio; padua, luca title: health profiles and socioeconomic characteristics of nonagenarians residing in mugello, a rural area in tuscany (italy) date: - - journal: bmc geriatr doi: . /s - - - sha: doc_id: cord_uid: tluo ztc background: health, as defined by the who, is a multidimensional concept that includes different aspects. interest in the health conditions of the oldest-old has increased as a consequence of the phenomenon of population aging. this study investigates whether ( ) it is possible to identify health profiles among the oldest-old, taking into account physical, emotional and psychological information about health, and ( ) there are demographic and socioeconomic differences among the health profiles. methods: latent class analysis with covariates was applied to the mugello study data to identify health profiles among the nonagenarians residing in the mugello district (tuscany, italy) and to evaluate the association between socioeconomic characteristics and the health profiles resulting from the analysis. results: this study highlights four groups labeled according to the posterior probability of determining a certain health characteristic: “healthy”, “physically healthy with cognitive impairment”, “unhealthy”, and “severely unhealthy”. some demographic and socioeconomic characteristics were found to be associated with the final groups: older nonagenarians are more likely to be in worse health conditions; men are in general healthier than women; more educated individuals are less likely to be in extremely poor health conditions, while the lowest-educated are more likely to be cognitively impaired; and office or intellectual workers are less likely to be in poor health conditions than are farmers. conclusions: considering multiple dimensions of health to determine health profiles among the oldest-old could help to better evaluate their care needs according to their health status. aging". this has been performed extensively among less older people in recent decades. however, as a consequence of the increasing number of oldest-old people in western societies and their health characteristics and needs, it is only in recent years that studies focusing on the oldest-old have been conducted, aiming to understand the potential drivers of good health conditions at extremely old ages [ ] [ ] [ ] [ ] [ ] . these studies have always focused on a specific dimension of health, such as cognition, physical and functional status or morbidities. however, health care needs are the result of a complex system of diseases, syndromes or health characteristics that cannot be described by a single dimension of health [ ] [ ] [ ] [ ] . to consider the multidimensionality of individual health status, it is necessary to exploit a personcentered approach that is based not on the relationships among variables but rather on the characteristics of the individuals. this approach allows people to be distinguished into groups by taking only their individual characteristics into account [ , ] . to capture the heterogeneity of health status and evaluate the social disparities among individuals, researchers suggest the use of latent class analysis (lca) as a person-centered approach [ ] [ ] [ ] . lca is a subset of structural equation modeling suitable for addressing multidimensional concepts, as in the case of health, to find groups of cases with similar characteristics in multivariate categorical data. the use of lca in population health studies is extensive, with applications that vary from younger [ ] to older individuals and elderly people [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . some scholars used this approach to identify profiles of health by considering functional, cognitive and psychological indicators [ - , , , ] , with some evaluating socioeconomic differences among the health profiles [ , , , ] and others predicting the health care expenditures of people belonging to different groups [ , ] . other researchers have applied a personcentered approach to identify profiles within a single aspect of health, such as morbidities [ , , ] , physical status [ ] , and depression [ ] , by considering several outcomes of the same health dimension. according to the existing literature, lca could be used to identify groups of individuals requiring specific forms of health care and to predict their health care needs and expenditures. this approach could also help policymakers understand which groups of people to target with their interventions. the recent covid- pandemic has again highlighted, especially in italy, how vulnerable people are, such as the oldest-old and multichronic patients, which are groups that merit greater health policy focus [ ] . it is also well documented that among elderly adults, demographic and socioeconomic characteristics influence health status and, consequently, health care needs and utilization [ , , ] . fewer researchers have evaluated this relationship among extremely old people, suggesting the persistence of social disparities in health, even in the last stages of life [ ] . gender, education and income were found to be associated with different health outcomes among the oldest-old individuals, prompting further investigation in this direction [ , [ ] [ ] [ ] [ ] . evaluating the existence of a demographic and socioeconomic gradient in health among the oldest-old population could drive the attention of policymakers toward people who need interventions. despite the recognized advantage of using a personcentered approach for capturing the heterogeneity of health among elderly people, there is still not much evidence relating to health profiles among the oldest-old and the extremely-old populations [ ] . to fill this gap in the literature, we analyzed data from the mugello study [ ] , which included nonagenarians from a rural area in tuscany (italy) called mugello. our aim is to determine whether it is possible to classify oldest-old people according to their multidimensional health status, defined by physical, cognitive and psychological health, to help in choosing the best care needed by this growing segment of the population. furthermore, we investigate whether there are demographic and socioeconomic differences among their health profiles, fueling the debate on social disparities in health in the last stages of life. the study population comes from the mugello study [ ] , which aimed to evaluate the aging process, focusing on different health aspects among nonagenarians living in of the municipalities of the mugello area in tuscany (italy). it comprised individuals representing approximately % of all nonagenarians living in that geographical territory in . the participation rate was % after the exclusion of potential participants who died before being interviewed or who were not found. more information about the study design and survey methods is available in molino-lova et al. [ ] . much information about the individual health conditions of nonagenarians has been collected. for some of the health tests, it was not possible to assess the health status of several patients. individuals who were not tested due to their (very) poor health conditions were categorized as nontestable. being nontestable is considered the worst health condition for each of the variables, including this category. variables have been categorized according to the existing literature. cognitive function was measured according to the mini-mental state examination (mmse): the higher the score ( - ), the better the cognitive status is [ ] . mmse scores were divided into three categories to distinguish people with severe ( - ), mild ( ) ( ) ( ) ( ) ( ) ( ) , and no cognitive impairment ( ) ( ) ( ) ( ) ( ) ( ) ( ) [ ] . functional status was assessed according to the ability to perform five of the activities of daily living (adls) (eating, dressing, bathing, toileting, transferring) [ ] . the number of adls that people could manage independently was used to distinguish between the non-( ), semi-( - ), and fully-autonomous ( ) oldest-old individuals [ ] . mugello's nonagenarians were classified as disease-free ( ), single-disease ( ), and comorbid ( +) according to the number of chronic diseases (cardiovascular, neurological, pulmonary, connective tissue, gastroenterological, endocrine, renal, oncological, immunodeficiency syndrome) reported. the geriatric depression scale (gds) was used to evaluate depression status: the higher the score ( - ), the higher the level of depression is [ ] . gds scores were divided into three categories to distinguish nondepressed ( - ), depressed ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , and nontestable individuals [ ] . self-rated health status was assessed using the italian version of the short form- questionnaire (sf- ) from which it was possible to obtain the two synthetic indicators combining the items together: the physical and mental component summaries (pcs and mcs) [ ] . the pcs and mcs were divided into three categories: those who scored higher (or equal) than the average were considered to be in good health, those who scored lower than the average were considered to be in poor health, and nontestable individuals were considered to be in the worst health. it was also possible to obtain the global self-rated health (srh) of the individual from the sf- , according to the first item of the questionnaire (in general, you would describe your health status as…). it was divided into three categories to distinguish among nonagenarians declaring excellent/very good/good health, declaring acceptable/poor health and being nontestable. the results are controlled for age ( - , - , +), gender, education ( - , , - , + years of education), and main occupation during the working lifespan defined according to the italian national institute of statistics (istat) classification of jobs [ ] : farmer; housewife; and low-skilled (laborer or unskilled worker) or mediumskilled (office, industry or intellectual worker) work. health is a complex state involving different aspects or dimensions. to capture the heterogeneity of the health status among the oldest-old individuals, we supposed that mugello's nonagenarians could belong to unobserved or latent classes according to their health characteristics. for this purpose, we chose lca, which aims to group individuals into classes according to their indicator patterns. each class includes individuals with similar characteristics that nonetheless differ from the characteristics of those in other classes. lca was used to identify different health profiles according to the health condition through the variables described in the previous paragraph, controlling for demographic and socioeconomic characteristics. lca with covariates is an extension of the basic lca, permitting the inclusion of covariates to predict an individual's latent class membership [ , ] . we performed the lca twice, including the same variables: once on the whole study population and once on the subsample of testable individuals. since we expected to obtain in the first analysis a group populated by only nontestable individuals, we excluded those people in the second analysis to capture more heterogeneity in health status for the remaining oldest-old individuals. the effect of the covariates has been estimated with the "onestep" technique to obtain less biased coefficients: they are estimated simultaneously as part of the latent class model [ , ] . suppose a latent class model with c classes is to be estimated according to m categorical variables and a covariate x. let y i = (y i , …, y im ) be the vector of an individual's response to the m variables, where y im = , , …, r m . let c i = , , …, c is the latent class membership of the individual to the class; let i(y = k) be the indicator function that is if y is equal to k and otherwise; and let λ be the probability of membership in each latent class. then, the latent class model can be expressed as follows: is a standard baseline category for the multinomial logistic model. in the case of one covariate, λ can be expressed as the following: where c is the reference class in the logistic regression. as a result, the log-odds of an individual falling into latent class c relative to the reference class c, giving x i as the value for the covariate, is the following: multiple imputation was necessary to address missing values (missing at random (mar)) to avoid a loss of precision in the analysis. the k-nearest neighbor imputation method has been used for its high performance with survey data [ ] . to obtain unbiased results, neighbors are found considering all the variables available in the dataset except those that are included in the models. five neighbors were considered to calculate the aggregated values to impute. education, main occupation during the working lifespan, mmse score, adls performed, number of chronic diseases, pcs and mcs were imputed. none had more than % missing values. more information about data imputation is included in table s in additional file . statistical analysis was performed using r version . . [ ] , vim [ ] , and the polca package [ ] . the participants included a high number of women ( ); the female/male sex ratio of . confirms the higher longevity of women. the mean age ± standard deviation was . ± . in the whole study population: the men's mean age ( . ) was lower than the women's mean age ( . ; t-test p = . ). men were more educated ( . % of males vs . % of females completed more than years of school) but performed more physical jobs: % of males vs . % of females were farmers or low-skilled workers. overall, men had better scores on all the health measures considered in the analysis. this result is partially explained by the sex-specific age structure of the study population. large gender differences were found in cognitive and functional status ( . % of males vs . % of females were not cognitively impaired; . % of males vs . % of females were autonomous). the gap in the remaining health measures is mainly due to the larger number of nontestable women (table ) . three latent classes were found when both the whole study population and the subsample of testable individuals were considered. this number was chosen according to the "meaning" of the classes, together with the akaike information criterion (aic) and the bayesian information criterion (bic), whose values are shown in table . every latent class has been labeled according to the posterior probabilities (λ) of finding a certain characteristic in the class, as shown in table . lca performed on the whole study population resulted in three health profiles. the first class is characterized by a high probability of being autonomous (λ = . ), not depressed (λ = . ), not cognitively impaired (λ = . ), perceiving good srh (λ = . ), and having values of pcs and mcs higher than or equal to the average (respectively, λ = . and . ). this class, labeled the "healthy group", includes individuals ( . % of the whole study population). the second class is characterized by a high probability of being semi−/not autonomous (respectively, λ = . and . ), cognitively impaired (λ = . ), and not testable for depression (λ = . ) and srh (λ = ); consequently, pcs and mcs were not testable (λ = for both indicators). this class has been labeled the "severely unhealthy group". it includes individuals ( . % of the whole study population), which encompassed almost all nontestable nonagenarians according to the scales in analysis that included this category (srh, depression, pcs and mcs). the third class includes nonagenarians with a high probability of being semiautonomous (λ = . ), mild/severely cognitively impaired (respectively, λ = . and . ), depressed (λ = . ), and having pcs and mcs scores lower than the average (respectively, λ = . and . ). despite how they performed in the objective health measures, they frequently declare a better health status: λ = . for declaring good srh conditions is relatively high (poor srh: λ = . ). for this reason, the last class, composed of ( . %) individuals, has been labeled the "partially satisfied unhealthy group". lca performed on the subsample of testable individuals also resulted in three health profiles. the first class is characterized by a high probability of being autonomous (λ = . ), not depressed (λ = . ), not cognitively impaired (λ = . ), reporting good srh (λ = . ), with pcs and mcs scores higher than or equal to the average (respectively λ = . and . ). this class has been labeled the "healthy group". it includes individuals ( % of the testable subsample) who were almost the same individuals populating the "healthy group" resulting from the first analysis. the second class is characterized by a high probability of being semiautonomous (λ = . ), depressed (λ = . ), and reporting poor srh (λ = . ), with pcs and mcs scores lower than the average (respectively λ = . and . ). this group of individuals ( . % of the testable subsample) has been labeled the "unhealthy group". the third group is characterized by a high probability of reporting good srh (λ = ) and being semiautonomous (λ = . ), mild/severe cognitive impairment (respectively λ = . and . ), with mcs scores lower (λ = . ) but pcs scores higher than or equal to the average (λ = . ). posterior probabilities for depression are similar: λ = . not-depressed vs λ = . depressed. this group was labeled "physically healthy with cognitive impairment". it included nonagenarians ( . % of the testable subsample). all the posterior probabilities are reported in table . the first class has been labeled the "healthy group" in both analyses: posterior probabilities followed a similar pattern, especially in terms of (good) health status items, as shown by the black and white circles in fig. . the second class of the analysis on the whole study population was named the "severely unhealthy group" (see black squares in fig. ) . it was composed of almost all the nontestable nonagenarians: individuals in the worst health conditions. excluding the nontestables for the second analysis, many individuals populating the third class moved to the second, resulting in an "unhealthy group" with less extreme health characteristics. the consequence of this exclusion was more evident for the last (third) class obtained in both analyses. when considering all nonagenarians, we obtained the "partially satisfied unhealthy group", i.e., people mainly in poor health conditions but not always declaring poor srh. when excluding the nontestable nonagenarians, some of the individuals populating the third group obtained in the previous analysis moved to the second group in the second analysis. as shown in fig. , the "partially satisfied unhealthy group" (first analysis) and the "unhealthy group" (second analysis) had similar posterior probabilities for the (good) health status indicators, especially in terms of functional and cognitive status. within the second analysis, out of the nonagenarians composing the "physically healthy with cognitive impairment group" had a higher probability of declaring good srh and obtaining a high pcs score than the "healthy group", but they had poor cognitive health, sometimes had depression and were mainly semiautonomous nonagenarians. the results are controlled for age, gender, education, and main occupation during the working lifespan (table ). in the analysis on the whole of mugello's nonagenarians, older individuals and housewives are more likely to be part of the "severely unhealthy group" instead of the "healthy group" ( - vs - : odds ratio (or) = . ; + vs - : or = . ; housewives vs farmers: or = . ), while being more educated reduces these odds ( - vs years of education: or = . ; + vs : or = . ). being older also increases the odds of empty items are due to the subsampling: not testable individuals are not included in the second analysis for both analysis : "healthy group"; respectively : "severely unhealthy group" and "unhealthy group"; and respectively : "partially satisfied unhealthy group" and "physically healthy with cognitive impairment group" to identify health profiles among nonagenarians from mugello (tuscany -italy), lca was performed twice: first on the whole study population and then on the subsample of testable individuals, with nonagenarians in the "extreme" (worst) conditions having been excluded from the analysis. removing these individuals from the analysis allowed us to capture more heterogeneity of health among the remaining oldest-old, especially among those with poor health that were hidden by the nontestable individuals. in both analyses, three classes were identified, resulting in a total of four different health profiles within the two lcas performed, each labeled according to the posterior probabilities of finding certain health characteristics in them. other researchers who looked at health profiles among elderly people by considering their physical, cognitive and psychological status found two to six classes [ - , , ] . in particular, other researchers could distinguish between a larger number of classes (four to six) [ , , , ] , except for ng et al. ( ) , who identified only two profiles [ ] . the fact that we found four health profiles within the two analyses means that, even at extremely old ages, there is still heterogeneity in the health conditions of the individuals. lca allowed us to take into account the multidimensionality of health by including several health measures in the analysis. having a larger study population could have helped to find the four profiles within a single lca. the "healthy group" (a), identified in both analyses and composed of almost the same individuals, and the "unhealthy group" (c), resulting from the second analysis, are consistent with other scholars' findings among younger adults, including information on sensory health and specific chronic diseases [ , ] or quality of life and wellbeing [ ] . additionally, among nonagenarians, it was possible to find the two extreme groups of people in overall good and poor health. the "severely unhealthy group" (b), resulting from the first analysis, confirms that nontestable individuals are a stand-alone group of fig. (good) health status item probabilities (λ) per health status resulting from the two latent class analyses (lcas). note : class : "healthy group", for both first (a) and second (b) lcas; class for lca-a: "severely unhealthy group", for lca-b: "unhealthy group"; class for lca-a: "partially satisfied unhealthy group", for lca-b: "physically healthy with cognitive impairment group". note : adls: activities of daily living; mcs: mental component summary; pcs: physical component summary; positive self-rated health: excellent/very good/good self-rated health people who, because of their extremely bad health conditions, cannot be tested on their health status. the "physically healthy with cognitive impairment group" (d), i.e., individuals with good self-rated health and physical condition but bad cognitive status, is similar to what lafortune et al. ( ) called the "cognitively impaired group" in their paper on the canadian elderly, where the authors did not include information on the perception of health [ ] . however, this result is at odds with what zammith and colleagues found in , in terms of selfperceived health, among the lothian birth cohort "good fitness/low spirit group" [ , ] . it is known that one of the factors influencing the assessment of health among italian elderly people is their physical status [ ] . it is possible that, even at extremely old ages, physical health plays an important role in the self-assessment of health status. however, this could also be the result of the poor cognitive status of individuals populating the "physically healthy with cognitive impairment group". certain demographic and socioeconomic characteristics were found to be associated with being part of some of the latent classes found. in this study, it is not possible to evaluate the health deterioration itself, but even at extremely old ages, being older results in having a higher probability of being in worse health. this suggests the need for further investigation on the health deterioration process among the oldest-old as it is commonly performed on the younger-old [ ] [ ] [ ] . males have a lower probability of being in worse general health conditions, confirming the so-called "gender paradox" also exists among the oldest-old: men are healthier than women at older ages [ , , , ] . the level of education is known to be associated with cognitive health in later life. researchers analyzing english and finnish nonagenarians show how this relationship still persists at extremely old ages [ , , ] . in the present study, more educated nonagenarians are less likely to belong to an "unhealthy group", while being less educated increases the probability of being among the cognitively impaired. these results are similar to those found in younger-elderly profiles [ , ] . working experience is also associated with health conditions, showing different results. in line with the existing literature, a person who was a nonmanual (office) worker had a lower probability for both analysis : "healthy group"; ; respectively : "severely unhealthy group" and "unhealthy group"; and respectively : "partially satisfied unhealthy group" and "physically healthy with cognitive impairment group" of being in bad health condition at older ages compared to someone who worked as a farmer [ , ] . housewives were more likely to be in the worst health conditions, similar to study findings among finnish nonagenarians [ ] . this study has public policy implications that need to be noted. even among nonagenarians, individuals are heterogeneous in terms of health. to capture this heterogeneity by taking into account several dimensions of health, it is necessary to apply a suitable methodology. lca has been widely used for this purpose, and policy makers should take advantage of it to identify heterogeneous groups of individuals to target with their interventions [ ] [ ] [ ] [ ] . analyzing different health dimensions at the same time allowed us to distinguish between the most vulnerable individuals with several health problems and those individuals with dimension-specific health deficits. according to our results, it is likely that people with poor physical health also have cognitive impairment, resulting in complex care needs. however, cognitively deteriorated individuals may be in good physical and functional status, requiring a different (specific) type of health assistance. furthermore, health profiles were associated with socioeconomic status, showing that even among the oldest-old, the well-known socioeconomic gradient of health persists. as pointed out by ng et al. ( ) , this should suggest policy makers drive their interventions to the less advantaged groups of the population [ ] . other researchers evaluated the health care needs and expenditures among taiwanese elderly people [ , ] , showing how they differ among the health profiles that they identified. being able to distinguish between groups of people with different health care needs is extremely important for reducing the excess of health expenditure that may result from not considering it holistically [ ] . this study has limitations that need to be noted. it is based on a cross-sectional dataset: health characteristics have been collected only once. for this reason, we were not allowed to study the causal relationship between sociodemographic characteristics and health status and profiles. furthermore, much of the information about health status is self-reported, and cutoff points -chosen according to the existing literature -did not equate to a clinical diagnosis. thus, it would be useful to verify their veracity with objective measures. finally, it is important to remark that mugello's nonagenarians are a selected group of individuals in terms of health and mortality. living in a rural area and following a mediterranean diet is, for instance, something that affects this selection. large samples of nonagenarians, for which much information has been collected about their health status, are still rare to find. considering health as a multidimensional concept by identifying health profiles could help to better evaluate the care needs according to the different health profiles of each person, even among extremely old individuals [ , ] . the demographic and socioeconomic gradient of health resulting from the analysis suggests that policy makers focus their interventions on specific groups of individuals at younger ages to prevent an excess of health care expenditure later on. supplementary information accompanies this paper at https://doi.org/ . /s - - - . additional file : table s . marginal distribution pre-and post-missing values imputation of characteristics of the study population. absolute values, percentages and differences. srh: self-rated health; who: world health organization cs, pp contributed equally to the conception of the study. cl, fv, cm, lp contributed to data acquisition. cs, pp, ve contributed to the data analysis and the interpretation of the results. all authors contributed to the drafting of the study. all authors read and approved the final manuscript. all authors agreed on both to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. the mugello study was partially supported by the italian ministry of health within the current research program performed at national research institutes (irccs). the authors received no financial support for the research, authorship, and/or publication of this article. the data that support the findings of this study are available from mugello study but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. data are however available from the authors upon reasonable request and with permission of mugello study. ethics approval and consent to participate the mugello study was conducted according to the helsinki declaration on clinical research involving human subjects and was approved by the don carlo gnocchi foundation ethics committee. informed written consent was obtained from all the participants, or their proxies, before their inclusion in the study. further details on the survey, including information on the territory and inhabitants, are available on the web (www.mugellostudy.com). not applicable. world health organization. global health and aging gender, health inequalities and welfare state regimes: a cross-national study of european countries world population prospects -population division -united nations n il monitoraggio della spesa sanitaria. rapporto n° . roma how to measure population aging? the answer is less than obvious: a review functional status and self-rated health in , nonagenarians: the danish cohort survey health and disease in year olds: baseline findings from the newcastle + cohort study belfast nonagenarians: nature or nurture? immunological, cardiovascular and genetic factors is there successful aging for nonagenarians? the vitality + study the mugello study, a survey of nonagenarians living in tuscany: design, methods and participants' general characteristics health status transitions in community-living elderly with complex care needs: a latent class approach health status profiles in community-dwelling elderly using self-reported health indicators: a latent class analysis the heterogeneous health latent classes of elderly people and their socio-demographic characteristics in taiwan the health heterogeneity of and health care utilization by the elderly in taiwan a latent class analysis of multimorbidity and the relationship to socio-demographic factors and health-related quality of life. a national population-based study of , danish adults utilization of health care services by elderly people with national health insurance in taiwan: the heterogeneous health profile approach profiles of physical, emotional and psychosocial wellbeing in the lothian birth cohort what factors influence healthy aging? a person-centered approach among older adults in taiwan identifying patterns of multimorbidity in older americans: application of latent class analysis depressive subtypes in an elderly cohort identified using latent class analysis latent profile analysis of walking, sitting, grip strength, and perceived body shape and their association with mental health in older korean adults with hypertension: a national observational study the frail older person does not exist: development of frailty profiles with latent class analysis socioeconomic inequality in clusters of health-related behaviours in europe: latent class analysis of a cross-sectional european survey multidimensionality of health inequalities: a cross-country identification of health clusters through multivariate classification techniques task force covid- del dipartimento malattie infettive e servizio di informatica, istituto superiore di sanità. epidemia covid- , aggiornamento nazionale: marzo . rome socioeconomic inequalities in morbidity among the elderly; a european overview socioeconomic status and health among the aged in the united states and germany: a comparative cross-sectional study do socioeconomic health differences persist in nonagenarians? association between chronic diseases and disability in elderly subjects with low and high income: the leiden -plus study gender effect on well-being of the oldest old: a survey of nonagenarians living in tuscany: the mugello study are there educational disparities in health and functioning among the oldest old? evidence from the nordic countries multimorbidity profiles in german centenarians: a latent class analysis of health insurance data mini-mental state": a practical method for grading the cognitive state of patients for the clinician the meaning of cognitive impairment in the elderly studies of illness in the aged: the index of adl: a standardized measure of biological and psychosocial function assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living /geriatric depression scale (gds): recent evidence and development of a shorter version screening for depression in elderly primary care patients: a comparison of the center for epidemiologic studies-depression scale and the geriatric depression scale questionario sullo stato di salute sf- . versione italiana. milano ist ric farmacol mario negri concomitant-variable latent-class models applied latent class analysis estimating latent structure models with categorical variables: one-step versus three-step estimators polca: an r package for polytomous variable latent class analysis nearest neighbor imputation for survey data r: the r project for statistical computing imputation with the r package vim the latent dimensions of poor self-rated health: how chronic diseases, functional and emotional dimensions interact influencing self-rated health in italian elderly transitions between states of disability and independence among older persons multi-state analysis of cognitive ability data: a piecewise-constant model and a weibull model understanding health deterioration and the dynamic relationship between physical ability and cognition among a cohort of danish nonagenarians the contribution of diseases to the male-female disability-survival paradox in the very old: results from the newcastle + study predicting risk of cognitive decline in very old adults using three models: the framingham stroke risk profile; the cardiovascular risk factors, aging, and dementia model; and oxi-inflammatory biomarkers heterogeneity in multidimensional health trajectories of late old years and socioeconomic stratification: a latent trajectory class analysis socio-economic position and subjective health and well-being among older people in europe: a systematic narrative review ageing and health springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the mugello study working group also includes: guglielmo bonaccorsi, roberta boni, chiara castagnoli, francesca cecchi, francesca cesari, francesco epifani, roberta frandi, betti giusti, maria luisa eliana luisi, rossella marcucci, raffaello molino-lova, anita paperini, lorenzo razzolini, francesco sofi, nona turcan, debora valecchi. the authors declare that they have no competing interests.author details interdisciplinary centre on population dynamics, university of southern denmark, j.b. winsløws vej b, nd floor, odense c, denmark. key: cord- -ios cuxc authors: golinelli, d.; boetto, e.; carullo, g.; landini, m. p.; fantini, m. p. title: how the covid- pandemic is favoring the adoption of digital technologies in healthcare: a rapid literature review date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: ios cuxc background. healthcare is responding to the covid- pandemic through the fast adoption of digital solutions and advanced technology tools. many of the solutions implemented now could consolidate in the near future, contributing to the definition of new digital-based models of care. the aim of this study is to describe which digital solutions have been reported in the early scientific literature to respond and fight the covid- pandemic. methods. we conducted a rapid literature review searching pubmed and medrxiv with terms considered adequate to find relevant literature on the use of digital technologies in response to covid- . results. the search identified articles, of which full-text articles were assessed and included in the review after screening. of selected articles, most of them addressed the use of digital technologies for diagnosis, surveillance and prevention. we report that digital solutions and innovative technologies have mainly been proposed for the diagnosis of covid- . in particular, within the reviewed articles we identified numerous suggestions on the use of artificial intelligence-powered tools for the diagnosis and screening of covid- . digital technologies are useful also for prevention and surveillance measures, for example through contact-tracing apps or monitoring of internet searches and social media usage. discussion. it is worth taking advantage of the push given by the crisis, and mandatory to keep track of the digital solutions proposed today to implement tomorrow's best practices and models of care, and to be ready for any new moments of emergency. on january , , the world health organization (who) stated that chinese health authorities have identified a new strain of coronavirus that has never been identified in humans before, subsequently classified under the name of severe acute respiratory syndrome coronavirus (sars-cov- ). the virus causes a respiratory disease called coronavirus disease . on march , the who itself formalized the covid- as a pandemic. the covid- pandemic, like all "serious disruptions" in human history, is causing an unprecedented health and economic crisis. at the same time though, this new situation is favoring the digital transition in many industries and in the society as a whole. this is the case, for example, of education [ ] . the entire sector, from primary schools to universities, has developed new strategies for teaching remotely, shifting from lectures in classrooms to live conferencing or online courses [ ] . similarly, now -and perhaps more prominently in the forthcoming months -healthcare is responding to the covid- pandemic through the fast adoption of digital solutions and advanced technology tools. in times of pandemic, digital technology can mitigate or even solve many challenges, thus improving health care delivery. this is currently being done to address acute needs that are a direct or indirect consequence of the pandemic (e.g. apps for patient tracing, remote triage emergency services, etc.). nevertheless, many of the solutions that are created and implemented at the moment of the current emergency could consolidate in the near future, contributing to the definition and adoption of new digital-based models of care. although with a certain degree of digital divide, the list of new digital solutions is rapidly growing. beyond video-visits, these options include email, and mobile-phone applications and can expand to include uses of wearable devices, "chatbots", artificial-intelligence (ai) powered diagnostic tools, voiceinterface systems, or mobile sensors such as smartwatches, oxygen monitors, or thermometers. a new category of service is oversight of persons under investigation in home quarantine and/or large-scale population surveillance. telemedicine and remote consultation have already proven to be effective at a time when access to health services for non-covid- or non-acute patients is prevented, impeded or postponed. in fact, as keesara et al. say [ ] , instead of a model "structured on the historically necessary model of in-person interactions between patients and their clinicians" through a face-to-face model of care, today healthcare services and patient assistance can be guaranteed remotely through digital technologies. before the covid- pandemic, it was expected that digital transformation in health care would have been as disruptive as that seen in other industries. however, as stated by hermann et al. [ ] , "despite new technologies being constantly introduced, this change had yet to materialize" [ ] . it appears that now, the spread of sars-cov- has finally provided an ineludible sound reason to fully embrace the digital transformation. moreover, simulations show that many countries will probably face several waves of contagions and new lockdowns will probably occur [ ] . therefore it becomes necessary to map which digital technologies have been used during the emergency period and possibly consider them for continued use over time or cyclically in the event of recurring outbreaks. according to hermann et al. [ ] digital technologies can be categorized based on the healthcare needs they address: diagnosis, prevention, treatment, adherence, lifestyle, and patient engagement. we argue that it is necessary to understand which digital technologies have been adopted to face the covid- crisis, and whether and how they can still be of any use after the emergency phase. the aim of this study is therefore to describe which digital solutions have been reported in the early scientific literature to respond and fight the covid- pandemic. we conducted a rapid review of the scientific literature to include quantitative and qualitative studies using diverse designs to describe which digital solutions have been reported to respond and fight the covid- pandemic. the initial search was implemented on april th, . the search query consisted of terms considered by the authors to review the literature on the use of digital technologies in response to covid- . therefore, we searched pubmed/medline using the following search terms and database-appropriate syntax: we also manually searched medrxiv/biorxiv (a preprint server for health science paper) section covid- /sars-cov- for digital technologies-related studies. we placed a language restriction for english, without other limits. a two-stage screening process was used to assess the relevance of identified studies. for the first level of screening, only the title and abstract were reviewed to preclude waste of resources in procuring articles that did not meet the minimum inclusion criteria. titles and abstracts of studies initially identified were checked by two independent investigators (d.g. and e.b.). for the second level of screening, all citations deemed relevant after title and abstract screening were procured for subsequent review of the full-text article. a form was developed to extract study characteristics such as publication date, authors' nationality, title, aim of the study, technology/ies, main findings/results, actual and potential use of the technology. in particular we categorized the retrieved papers according to the healthcare needs addressed (diagnosis, prevention, treatment, adherence, lifestyle, and patient engagement). the definition of each healthcare need is reported in table . we added "surveillance" as an additional healthcare need to those identified by hermann et al. [ ] , given the importance of early identification and confinement of covid- patients to preserve population health. two of us (d.g. and e.b.) independently classified all identified articles in the predefined categories. any disagreements were resolved through discussion and consensus between the two reviewers. if disagreement persisted, another reviewer (g.c.) was called as a tie-breaker. the process of determining which disease or condition explains a person's symptoms and signs. the continuous, systematic collection, analysis and interpretation of health-related data needed for the planning, implementation, and evaluation of public health practice preventing the occurrence of a disease (e.g. by reducing risk factors) or by halting a disease and averting resulting complications after its onset. the degree to which a patient correctly follows medical advice. the use of an agent, procedure, or regimen, such as a drug, surgery, or exercise, in an attempt to cure or mitigate a disease adoption and sustaining behaviors that can improve health and quality of life to actively involve people in their health and health care the pubmed and medrxiv search identified articles, of which full-text articles were assessed and included in the review after screening. of selected articles ( table and table ), . % addressed the use of digital technologies for diagnosis [ , , , , , , , , , , , ] , . % for surveillance [ , , , , , , , , , , ,] , . % for prevention [ , , , , , , , , , ] , . % for treatment [ , , ] and . % and . % for adherence [ , ] and lifestyle [ ] . no articles included in the review addressed the use of digital technologies specifically for patient engagement. in table (supplementary materials) we resume the results of the literature review. below we provide a summary of the existing digital solutions for the fight against covid- reported in the scientific literature available to date. in order to do this, we discuss the retrieved articles for each of the healthcare needs/domains. patient engagement *the total is higher than % because some articles may include technologies used to address more than one healthcare need. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . we report that digital solutions and innovative technologies have mainly been proposed for the diagnosis of covid- . in particular, within the reviewed articles we identified numerous suggestions on the use of ai-powered tools for the diagnosis and screening of sars-cov- or covid- . most studies propose the adoption of ai tools based on the use of cts' data [ , , , , , ] . for example, zhou et al. [ ] developed and validated an integrated deep learning framework on chest ct images for auto-detection of novel coronavirus pneumonia (ncp), particularly focusing on differentiating ncp from influenza pneumonia (ip), ensuring prompt implementation of isolation. their ai model potentially provides an accurate early diagnostic tool for ncp. therefore, a diagnostic tool like this can be useful during the pandemic, especially when others such as nucleic acid test kits are short of supply, which is a common problem during outbreaks. nonetheless, performing ct scans as a screening method presents significant limits, both considering the risk of radiation exposure, and operator or machine-type dependence [ ] . aside from these studies, many authors propose covid- ai-powered diagnostic tools not based on ct scans data [ , , , ] . feng et al. [ ] developed and validated a diagnosis aid model without ct images for early identification of suspected covid- pneumonia on admission in adult fever patients and made the validated model available via an online triage calculator that needs clinical and serological data (e.g. age, %monocytes, il- , etc.). similarly, martin et al. [ ] proposed a chatbot and a symptomto-disease digital health assistant that can differentiate more than , diseases with an accuracy of more than %. the authors tested the accuracy of the digital health assistant to identify covid- using a set of diverse clinical cases combined with case reports of covid- , and reported that the digital health assistant can accurately distinguish covid- in % of clinical cases. however, the article declares several limitations of the analysis, such as the low number of control clinical cases, and it is currently published as pre-print, therefore has yet to be peer reviewed. a further innovative digital technology proposed to support the diagnosis of covid- is the blockchain (or distributed ledger) technology. in one study [ ] authors recommend a low cost blockchain and aicoupled self-testing and tracking systems for covid- and other emerging infectious diseases in low middle income countries (lmic). they developed and deployed a low cost blockchain and ai-coupled digital application (app) suggesting it as a potential tool against covid- . the app requests a user's personal identifier before opening pre-testing instructions. following testing, the user uploads results into the app and the blockchain and ai system enable the transfer of the test result to alert the outbreak surveillance. these types of solutions can also be of interest in high income countries. our literature review suggests that digital technologies can be useful for covid- diagnosis as well as for implementing prevention and surveillance measures. in judson et al. [ ] , authors deploy a coronavirus symptom checker that is a digital patient-facing selftriage and self-scheduling tool in a large academic health system to address the covid- pandemic. the purpose of this tool was to provide patients with -hour access to personalized recommendations and information regarding covid- , and to improve ambulatory surge capacity through self-triage, selfscheduling and avoidance of unnecessary in-person care. the majority of patients involved in the use of the app did not make any further contact with the health system during the subsequent days. therefore, such tools may help in preventing unnecessary face-to-face appointments and access to healthcare facilities. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . another topic of paramount importance in the context of healthcare digitalization is epidemiological surveillance. our review highlights that prevention and surveillance are often considered together in the scientific literature, given that "prevention of covid- " can be intended as "prevention of further spread", which is mainly done through surveillance. for covid- pandemic, surveillance definitely overlaps with prevention, since by applying a successful surveillance plan and controlling the interactions between infected subjects and the healthy population the risk of infection can be reduced. a study by ferretti et al. [ ] analyzes the key parameters of the covid- epidemic spread to estimate the contribution of different transmission routes and determine requirements for successful case isolation and contact-tracing. the authors concluded that viral spread is too fast to be contained by manual contact tracing, but could be controlled if this process is faster, more efficient and happens at scale. the solution is the implementation of a contact-tracing app which creates a temporary record of proximity events between individuals, and immediately alerts recent close contacts of diagnosed cases and prompts them to self-isolate. an important limitation of this kind of tracing technology is that, in order to achieve its goal, it must be used by a significant portion of the population. an example of successful use of a mobile application for contact tracing is the one that the chinese government has implemented in wuhan, as described by hua et al. [ ] . a qr code-screening of people was implemented in the city of wuhan and, later, in the whole hubei province. this qr code was used to monitor people's movement, especially on public transportation entering public areas. using big data and mobile phones, three colors coding were attributed to each citizen: green (safe), yellow (need to be cautious), and red (cannot enter). a similar tool was implemented in taiwan [ ] . in fact, through the taiwan citizens' household registration system and the foreigners' entry card, it was possible to track individuals at high risk of covid- infection because of their recent travel history in affected areas. if identified as high risk when in quarantine, the subjects were monitored electronically through their mobile phones. then, the entry quarantine system was launched: through the completion of an health declaration form (requiring the scan of a qr code that leads to an online form, either prior to departure from or upon arrival at a taiwan airport) travelers could receive a fast immigration clearance. our literature review suggests that another meaningful way to control the spread of an epidemic is through monitoring/surveillance of internet searches and social media usage. wang et al. [ ] used wechat, a chinese social media, to plot daily data on the frequencies of keywords related to sars-cov- . the authors found that the frequencies of several keywords related to covid- behaved abnormally during a period ahead of the outbreak in china and stated that social media can offer a new approach to early detect disease outbreaks. similarly, the italian words for "cough" and "fever" have been searched in google trends to find useful insights to predict the covid- outbreak in italy, showing a significant association with hospital admissions or deaths in the two following weeks [ ] . these two papers show that tracking public health information from online search engines might have a role in the prediction of future covid- waves, complementarily to traditional public health surveillance systems. although its potential is irrefutable, the technology behind surveillance and contact tracing apps raises many concerns, as discussed by calvo et al. [ ] , the most obvious one being "surveillance creep", that is when a surveillance tool developed for a precise goal (in the case of china and taiwan, an app to monitor people's movement) sticks around even when the crisis is solved. privacy must be a primary concern for the policy makers and a key challenge for designers and engineers that design the digital tools for epidemic control. as already outlined in a previous work by carullo [ ] , in the eu applications to combat covid- should not process personal data whenever possible. the general data protection . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . regulation (gdpr) dictates the principle of privacy by default, that is "by default, only personal data which are necessary for each specific purpose of the processing are processed". in this regard, it should be reminded that according to the gdpr, data is "personal" only when and insofar it allows the identification of a natural person. therefore, the processing of data, including clinical data, which cannot in any way identify a natural person, is not personal data. which therefore completely rules out any privacy concerns. to be compliant with this principle, a preferable approach is therefore to trace the spread of the virus, and therefore alert users, without collecting any personal data. a promising example that goes in this direction is brought by yasake et al. [ ] , with their open source proof-of-concept app for contact tracing that does not require registration or the divulgation of any private data, such as location. instead, this tool utilizes an ingenious "checkpoint" system, that allows the users to create a peer-to-peer network of interactions and to know if they have been exposed to any risk of infection; diagnosis of infection can be logged into the app, the data is transferred to a central server but stays anonymous. while the aforementioned articles addressed surveillance and prevention in outpatients and the general population, an interesting point-of-view on inpatients surveillance comes from the study by lin et al. [ ] . this paper describes a prospective active surveillance system with information technology services (i.e. using a surveillance algorithm based on data from electronic medical records) to identify hospital inpatients whose pneumonia did not show marked improvement with antibiotic treatment and to alert the primary care medical teams on a daily basis. in regard to the field of prevention, other important digital technologies proposed in the literature are telemedicine and telehealth [ , , , , , ] . nonetheless, telemedicine does not always cover emergencies, and, differently from the article by lin et al. [ ] , many covid- patients may need to go to the hospital for higher level care. for this purpose, turer et al. [ ] propose using electronic personal protective equipment (eppe) to protect staff and conserve ppe while providing rapid access to emergency care and fulfilling emergency medical treatment and active labor act (emtala) obligations for low risk patients during the covid- pandemic. eppe has potential applicability to settings such as emergency medical services, medical wards, and intensive care units. telemedicine and telehealth technologies are also used to increase patient adherence and for treatment purposes. an article that considers using telemedicine/telehealth is the one by tourous et al. [ ] . in it, the authors describe the potential of digital health to increase access and quality of mental health care. they make examples of digital health innovations and explore the success of telehealth during the present crisis and how technologies like apps can soon play a larger role. telehealth is seen as a useful solution to deliver mental health care commonly [ ] , and during social distancing and quarantine periods. in addition, digital therapy programs can also be offered through courses of evidence-based therapies, or using augmented and virtual reality systems. as another example, calton et al. [ ] deliver some useful tips on the implementation of telemedicine to deliver specialty-palliative care into the homes of seriously ill patients and their families. the authors state that digital divide must be taken into account. patients need access to a digital device suited for video conference and to an internet connection. for the elderly or the less prone to technology, it may be necessary to identify a caregiver as a "technological liaison" for the patient. the appointment must be well coordinated and there must be a contingency plan if the meeting does not start at the scheduled time. hence, to create a successful treatment telemedicine environment, many critical factors are needed: . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint workforce training, high-quality evidence, digital equity, and patient adherence. while sars-cov- is causing a pandemic worldwide, it is also favoring the rapid adoption of digital solutions and advanced technology tools in healthcare practice. on the one hand, physicians and health systems may need to track large populations of patients on a daily basis for surveillance purposes [ ] . on the other hand, they may need fast diagnostic tests for covid- screening, in order to reduce the workload and enable patients to get early diagnoses and timely treatments. this is also done with the help of digital technologies, which were already available in different industries before the current crisis. these tools have now been implemented in healthcare due to the pandemic. in this rapid literature review we describe numerous digital solutions and technologies addressing several healthcare needs, with particular regard to diagnosis, prevention and surveillance. the constantly updated scientific literature is a source of important ideas and suggestions for finding innovative solutions that guarantee patient care during and possibly after the covid- crisis. in the field of diagnosis, digital solutions that integrate with the traditional methods of clinical, molecular or serological diagnosis, such as ai-based diagnostic algorithms based both on imaging and/or clinical data, seem promising and widely used. the literature shows interesting digital tools also in the field of prevention and surveillance. in the first case, the concept of electronic personal protective equipment (eppe) seems very promising and would allow high standards of care, while ensuring the safety of patients and operators. as for surveillance, digital apps have already proven their effectiveness, but problems related to privacy and usability remain. for other healthcare needs, various solutions have been proposed using, for example, telemedicine or telehealth tools. these have long been available, but perhaps this historical moment could actually favor their definitive large-scale adoption. however, all of this is easier said than done. in the context of the "health care's digital revolution" [ ] brought to the usa (and worldwide) by the covid- pandemic, while private corporations and education institutions have made a quick transition to remote work and videoconferencing, the healthcare system is still lagging behind in adopting digital solutions. this is mainly due to the fact that clinical workflows and economic incentives have been developed for a face-to-face model of care which, during this pandemic, contributes to the spread of the virus to uninfected patients who are seeking medical care. other than healthcare policies "history", there are additional limiting factors to the implementation of tools like telemedicine, including a legal framework that is not yet fully designed to regulate the use of innovative it systems in healthcare, as well as an inadequate ict infrastructure and an obsolete reimbursement and payment structure. other countries are facing the same regulatory issues of the usa, like italy -the first western country to experience a total lockdown due to the covid- pandemic [ ] . therefore the challenges for digital health have become a global issue into the public health response to covid- and future outbreaks. digital tools such as telemedicine should indeed be integrated into international and national guidelines for public health preparedness, alongside the definition of national regulations and funding frameworks in the context of public health emergencies. in order to switch to new digital-based models of care (e.g. using outpatient teleconsultations), increasing digital-expertise of health care professionals and educating the population are fundamental issues. moreover, by implementing a data-sharing mechanism, digitally collected and stored data will be a precious tool also for epidemiological surveillance, that, as discussed . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . earlier, is fundamental in controlling the epidemic spread. lastly, in order to describe and assess the impact of digital tools during outbreaks, scientific evaluation frameworks should be defined. this rapid literature review presents some limitations. first, the research was conducted in a period of epidemiological emergency. this determines a large number of daily publications, which is difficult to keep up to date. as a result, we have been forced to select articles in a reduced time span, potentially missing other studies and including studies yet to be peer-reviewed. secondly, due to the design of the rapid review, the search could not be fully comprehensive, as it was conducted exclusively on pubmed and medrxiv. finally, the articles and concepts included in this preliminary review certainly need to be afterwards integrated at the end of this international emergency phase. in conclusion, the covid- crisis is favoring the implementation of digital solutions at a speed and with an impact never seen before. it is therefore mandatory to keep track of the ideas and solutions proposed today to implement tomorrow's best practices and models of care, and to be prepared in case of future national and international emergencies. we believe that it is worth taking advantage of the push given by the crisis we are experiencing today to implement at least some of the solutions proposed in the scientific literature, especially in those national health systems which in recent years proved to be particularly resistant to the digital transition. covid- : a new digital dawn five tips for moving teaching online as covid- takes hold covid- and health care's digital revolution digital transformation and disruption of the health care sector: internet-based observational study strategies for delivering value from digital technology transformation projecting the transmission dynamics of sars-cov- through the postpandemic period improved deep learning model for differentiating novel coronavirus pneumonia and influenza pneumonia deep learning-based detection for covid- from chest ct using weak label a novel triage tool of artificial intelligence assisted diagnosis aid system for suspected covid- pneumonia in fever clinics ai-assisted ct imaging analysis for covid- screening: building and deploying a medical ai system in four weeks a fully automatic deep learning system for covid- diagnostic and prognostic analysis an artificial intelligence based first-line defence against covid- : digitally screening citizens for risks via a chatbot predicting covid- malignant progression with ai techniques deep learning-based recognizing covid- and other common infectious diseases of the lung by chest ct scan images blockchain and artificial intelligence technology for novel coronavirus disease- self-testing wearable cardiorespiratory monitoring employing a multimodal digital patch stethoscope: estimation of ecg, pep, lvet and respiration using a mm single-lead ecg and phonocardiogram. sensors (basel) rapid implementation of mobile technology for real-time epidemiology of rapid design and implementation of an integrated patient self-triage and self-scheduling tool for covid- wechat, a chinese social media, may early detect the sars-cov- outbreak in response to covid- in taiwan: big data analytics, new technology, and proactive testing application of personal-oriented digital technology in preventing transmission of covid- , china peer-to-peer contact tracing: development of a privacy-preserving smartphone app infodemic" and emerging issues through a data lens: the case of china active surveillance for suspected covid- cases in inpatients with information technology quantifying sars-cov- transmission suggests epidemic control with digital contact tracing covid -tracker: a shiny app to produce comprehensive data visualization for sars-cov- epidemic in spain health surveillance during covid- pandemic : how to safeguard autonomy and why it matters digital mental health and covid- : using technology today to accelerate the curve on access and quality tomorrow covid- epidemic in switzerland: growth prediction and containment strategy using artificial intelligence and big data electronic personal protective equipment: a strategy to protect emergency department providers in the age of covid- global telemedicine implementation and integration within health systems to fight the covid- pandemic: a call to action quantifying the effect of quarantine control in covid- infectious spread using machine learning telemedicine in the time of coronavirus mechanical ventilator milano (mvm): a novel mechanical ventilator designed for mass scale production in response to the covid- pandemics. medrxiv . . google trends and covid- in italy. could we brace for impact? (preprint) digitalization of controls at the time of coronavirus economics of mental health: providing a platform for efficient mental health policy. appl health econ health policy n/a the authors declare that they have no competing interests. the authors declare that they have not received any specific funding. key: cord- -dmb ls authors: edge, chantal; hayward, andrew; whitfield, angelique; hard, jake title: covid- : digital equivalence of health care in english prisons date: - - journal: lancet digit health doi: . /s - ( ) - sha: doc_id: cord_uid: dmb ls nan the importance of achieving health-care services for prisoners that are equivalent to those for the community is an international ethical and moral principle. less discussed is digital equivalence, a term that we have coined to reflect equivalence of digital innovation, con sidered in relation to prison telemedicine and covid- . at outset of the pandemic, it was hypothesised that covid- outbreaks within prisons could lead to high levels of illness and death. prisons quickly implemented a full lockdown, including stopping external visitors, isolation within prison cells for up to h a day, plans for early release of prisoners, and compartmentalisation. in alignment with community responses, a spotlight was cast on the notion of prison telemedicine. uk national health service (nhs) bodies within english community settings had reacted quickly to the pandemic by adopting digital innovations, including the widespread use of video consultations. nhs bodies rallied to pro vide streamlined support for the mass roll-out of telemedicine, with centralised review, coordination, and procurement of software solutions for community health-care settings. yet at the commencement of the pandemic, prisons were triply disadvantaged: first, in regard to the baseline poor health status of residents; second, by the closed and crowded prison environment; and third, by their poor adoption history of digital technologies. widespread prison telemedicine implementation efforts previously struggled to find traction in england, yet were suddenly perceived as one of the most important tools to maintain health-care service continuity throughout the pandemic (appendix). despite the clear rationale for a rapid deployment programme to mirror community efforts, several issues emerged that inhibited the ability to transform health care in prison settings at the same speed. prisons, by their nature, are secure environments, concerned primarily with delivering the order of the courts. access to health care and permissions for the introduction of digital technologies must be oper ationalised within the constraints and security policies of her majesty's prison and probation service (hmpps). hmpps rules surrounding technology surpass those of the nhs and must be adhered to. any digital technology outside the prison authority's direct control is inherently perceived as a risk. hmpps must investigate and approve any digital solution that is to be implemented within prisons to assure security, including health-care technologies. at the commencement of the pandemic, only two telemedicine solutions were approved for use in prisons, having been subject to hmpps scrutiny lasting several years. these technologies were not among centrally procured and deployed nhs solutions. this digital divide meant that prisons could not benefit from the widespread national support for telemedicine. video consultations require an internet connection sufficient to support use. at the point of the pandemic declaration, approximately of prison sites had connectivity that was too poor for videoconferencing. in community health-care settings, poor connectivity is negated with the availability of secure virtual private network connections, widespread availability of wi-fi, and a g signal, yet hmpps prohibits these solutions to reduce the risk of unauthorised communications by prisoners. this issue of connectivity, despite being critical to nhs service delivery, became an issue to be solved through hmpps channels and cooperation. prison health-care commissioning was transferred to the nhs in , meaning service delivery and clinical it remain in their infancy. the english prison estate has many competing prison health-care providers from private, voluntary, and nhs sectors. this competitive tendering system for offender care has been suggested to increase incoherence among services and provide fragmented care. procurement of a centrally mandated telemedicine service for use by all prisons was further complicated by provider multiplicity and compatibility with existing it services. the pandemic did not only expose the limiting factors precluding prison digital revolution but also presented an opportunity to lift barriers. to miti gate issues with poor connectivity, hmpps supported legislation changes to allow introduction of g-enabled tablets in the prison environment for telemedicine. this unprecedented change was welcomed by health-care management, yet still took months to deploy, and at large expense, because of the bespoke con figurations required to operationalise tablets in a secure environment. this meant that despite rapid permissions, devices remained unavailable until the first pandemic peak had passed; should a second peak occur, prisons will be more prepared. as a result of the pandemic, all prisons, immigration removal centres, and secure children's homes in england (n= ) will have g-enabled tablets, telemedicine capability, and mobile use of electronic health records. covid- has acted as a catalyst for a new era of digital innovation in prison health care. we cannot wait for another future crisis to prompt digital innovation in prisons, and we must nurture the partnership approach established between hmpps digital teams and the nhs. we must undertake responsive, robust security evaluations of new digital technologies to ensure that prisons cannot only adopt innovations after they have become commonplace in the community. digital innovation will accelerate advancement in other aspects of prison health care, improving health outcomes. the prison health system was pushed to consider rapid implementation of digital technology to support the pandemic response and maintain essential healthcare services for their vulnerable population. however, prison services started from a lower digital baseline, were unable to use software rapidly procured and deployed in community settings, and were bound at all times to the additional rules of the prison system on use of technology. failure to keep pace with the rapid adoption of digital innovation in the community in response to the pandemic will widen this digital inequivalence. prisons are already behind the accelerating curve of community implementation, and risk falling further behind, bringing even greater patient disadvantage, if momentum is not maintained. although this discussion focuses on prison telemedicine, we argue that these principles apply across the whole spectrum of health-care technology, such as wearables and electronic health records. the long-term repercussions of reduced in-prison health-care services due to in-cell confinement and reduced health-care staffing will echo past the pandemic. despite hopes for the early release of up to prisoners nearing the end of their sentence, so far less than have been successfully released, probably as a result of the complexities associated with undertaking stringent risk assessments on individual cases. although people remain in prison, we must ensure that we have the ways and means to deliver health care to them under pandemic conditions, and to catch up with any healthcare shortages that have arisen as a consequence. telemedicine promises to improve health service access in prisons, reduce widening health inequalities, and contribute to improved health outcomes. we must evaluate future progress to ensure that it does not further disadvantage patients by harming doctorpatient relationships or acting purely as a cost-saving mechanism. we hypothesise that telemedicine will reduce referral to treatment times for patients, increase access to a wider range of specialist services (eg, gender identity clinics), reduce the waiting time for gatekeeping assessments under the mental health act, and increase overall access to health-care appointments. prisoners traditionally access secondary care offsite at local hospitals, handcuffed and accompanied by prison officers (escorts). they report feelings of dehumanisation, stigma, and judgment from the public and hospital staff. clinical information handover to prison health-care teams can be poor, and patients might face long waits for routine appointments given that the availability of prison officer escorts is limited by staffing pressures. use of prison telemedicine for secondary care can alleviate all of these issues and improve patient experience. all of these factors must be rigorously assessed, alongside cost-effectiveness and the safety and quality of remote prescribing, to understand whether telemedicine in prisons delivers the benefits envisioned for patients during the pandemic and beyond. in parallel, hmpps will continue to monitor and appraise the telemedicine system for security and safety within secure establishments. briefing paper-interim assessment of impact of various population management strategies in prisons in response to covid- pandemic in england video consultations for covid- approved video consultation systems improving care quality with prison telemedicine: the effects of context and multiplicity on successful implementation and use department of health and social care, ministry of justice, her majesty's prison and probation service and public health england information sharing protocol across secure and detained settings nhs england primary care patient records in the united kingdom: past, present, and future research priorities competitive tendering and offender health services secondary care clinicians and staff have a key role in delivering equivalence of care for prisoners: a qualitative study of prisoners' experiences key: cord- -azh npc authors: sharma, manoj kumar; anand, nitin; vishwakarma, akash; sahu, maya; thakur, pranjali chakraborty; mondal, ishita; singh, priya; sj, ajith; n, suma; biswas, ankita; r, archana; john, nisha; tapatrikar, ashwini; murthy, keshava d. title: mental health issues mediate social media use in rumors: implication for media based mental health literacy date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: azh npc nan research involving human participants and/or animals:.all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the helsinki declaration and its later amendments or comparable ethical standards. j o u r n a l p r e -p r o o f social media use has recently become immensely popular not only for its leisure activities through connecting people over the world, but also for keeping updated with the current trends through news and sharing information. it provides a perfect platform to interact with others by offering opportunities to share a user's thoughts, emotions, pictures, videos and creative ideas through posts or blogs (kuss & griffiths, b , a . hence, one important characteristic of social media platforms is rapid spreading of information through its users which is usually impactful. another concern is when it comes to health related information sharing on social media. as open to all, anyone can produce information and publish in the digital forum, share experiences, form their own perspectives which remain unverified by any professional news channel, editors or factcheckers (sommariva, vamos, mantzarlis, uyên-loan Đào, & tyson, ) . thus, social media comes with its own limitations for misinformation in the form of rumours or fake news (zubiaga, liakata, procter, wong sak hoi, & tolmie, ) . moreover, once rumors begin to spread on social media, they are very difficult to control with updates or corrections (jones, thompson, dunkel schetter, & silver, ) . among these, health rumors which are unverified information regarding the practice of medicine and healthcare, often endanger public health (oh & lee, ) . hence, it is important to understand the role and impact of social media in spreading rumours and verify information before sharing it with others. research literature has found that social media has power in influencing people's behavior when there is an outbreak of epidemic or pandemic. over the decades, social media has been flooded with misinformation on diabetes, anorexia as well as anti-vaccination content along with the recent zika virus or ebola epidemic (fernández-luque & bau, ; sommariva et al., ) . the news of the ebola epidemic created a climate of global nervousness with rumours and misinformation quickly spreading through social media platforms. similar trend is being observed with current occurrence of severe acute respiratory syndrome coronavirus (sars-cov- ) which has been declared as a pandemic. studies have also documented that during crisis events, people often seek out event-related information to stay informed of what is happening. if there is lack of official information, people may be at risk for exposure to rumors that fill the information void (jones et al., ) . additionally, constant assault of information through social media also leads its users to easily consume available information irrespective of its authenticity. in this is the era of "headline stress disorder", a lot of negative feelings like anxiety, hopelessness, despair, and sadness is fueled by being regulated by the (sharma & seshadri, ) . similarly, suicide is another public mental health problem where media and social media play a significant role in either increasing or curtailing the problem within the society. the available literature in bangladesh and india suggests that media reporting about suicide includes information which offers details name of the victim, their occupation, method of suicide, images of suicide victims, suicide notes and citations form suicide notes. this is the information which works to make the news attractive and shares details which increase access to information for harming self and may also work to create misinformation or rumors (arafat, mali & akter, ; armstrong et al., ; jain and kumar, ) . however, the media does not highlight information to educate the general population about what are early signs of suicidal behaviors, prevention plans and expert opinions from mental health professionals, helpline numbers for support and availability of emergency services in hospitals. these findings further suggest that the reports in media on suicide do not follow the guidelines issued by the world health organization (who) and other health regulatory bodies on reporting of suicide in media (arafat, mali & akter, ; armstrong et al., ; cherian, lukose, rappaia et al., ; jain and kumar, ) . there are similar irregularities j o u r n a l p r e -p r o o f which indicate reporting of sensitive information about suicide in a detrimental manner in media in china as well (chu et al., ) . thus, in the light of the existing information, it becomes understandable that media in all its formats have a huge impact and more significantly has a role to report responsibly the information in an educative format which is related to health of the population. in addition, it needs to be more sensitive and responsible in reporting about public health problems like the sars-cov- , and suicide where the focus is on offering information which is helpful for prevention, details the steps to take in times of the health emergency, offers expert opinions from mental health professionals, helpline numbers for support and emergency services in hospitals. this role of media will surely work to minimize the digital content which leads to creation of misinformation or rumors. to summarize, in addition to the responsible role of media in reporting about public health problems, the individual's members of the population, the government, policy makers, health regulatory bodies and health professionals need to collaborate and develop guidelines for responsible dissemination of information over all kinds of media formats with respect to public health problems. such guidelines will also work to improve the media based literacy about health and mental problems among the population and will be extremely helpful for use in times of public health emergencies like the sars-cov- pandemic. the development of such guidelines are crucial as the pattern of epidemics and pandemics changes over time, but the cycle of rumors or fake news or inaccurate media reports continues to revolve around media formats and especially in social media likely due to stress, anxiety and other psychological factors of individuals which requires to be studied in greater detail. is suicide reporting in bangla online news portals sensible? a year-round content analysis against world health organization guidelines assessing the quality of media reporting of suicide news in india against world health organization guidelines: a content analysis study of nine major newspapers in tamil nadu adolescent suicide in india: significance of public health prevention plan assessing the use of media reporting recommendations by the world health organization in suicide news published in the most influential media sources in china health and social media: perfect storm of information is suicide reporting in indian newspapers responsible? a study from rajasthan distress and rumor exposure on social media during a campus lockdown daria j . kuss and mark d . griffiths excessive online social networking : can adolescents become addicted to facebook ? education and health online social networking and addiction -a review of the psychological literature when do people verify and share health rumors on social media? the effects of message importance, health anxiety, and health literacy adolescence: contemporary issues in the clinic and beyond spreading the (fake) news: exploring health messages on social media and the implications for health professionals using a case study analysing how people orient to and spread rumours in social media by looking at conversational threads key: cord- -pxzsntfg authors: milenkovic, aleksandar; jankovic, dragan; rajkovic, petar title: extensions and adaptations of existing medical information system in order to reduce social contacts during covid- pandemic date: - - journal: int j med inform doi: . /j.ijmedinf. . sha: doc_id: cord_uid: pxzsntfg objective: the main objective of this paper is the reduction of the covid- pandemic spread by increasing the degree of social distancing by using and upgrading the existing medical information system (mis). material and methods: the existing mis medis.net, currently used in the largest health center in the balkans, has been adapted and further developed. results: during the adaptation of existing mis medis.net new and existing modules were developed. a quick questionnaire for the smart triage of patients was also implemented. discussion: the adapted mis successfully influenced the reduction of social contacts within the health center nis. the need for the arrival of children and their parents to receive appropriate health certificates for the school enrolment is reduced. the therapy of chronic patients has been prolonged for months via an electronic prescription. an online service for the communication between patients and the chosen physicians is provided. possible social contacts and exposure to the viral environment of patients are reduced by making appointments in extended slots and at determined physical locations. patients are notified per sms or email about the availability of chosen and physician on duty. the social distancing of patients and physicians is also established by sending laboratory analyses per email or sms. keeping the central registry for covid- is enabled throughout the country. conclusion: the smart adaptation of mis, and its collaboration with other state systems can significantly influence the reduction of social contacts and thus mitigate the consequences of covid- pandemic. the emergence and rapid expansion of major epidemics, besides the influence on the daily lives of people through changing health, economic, working style, social and political routines, also has a significant impact on existing information technology (it) products, with a great emphasis on large-scale information systems (is) which are exploited on a daily basis. during outbreaks, especially those with a pandemic character, the following key activities [ ] which are updated with covid- strategy [ ] have been identified whose strict implementation has an impact on the reduction of number of infected people and suppression of the spread of epidemic: . isolation of persons who are suspected to be infected with the virus [ ] (the persons not yet diagnosed with the disease), . monitoring persons during home isolation in order to check whether they follow the rules of self-isolation, . make as many digital (government, administration, health such as telehealth [ ] ) online services as possible available to people to reduce their need to exit and be exposed to the infectious environment. the main problem that naturally arises is the efficient suppression of the rapid spread of epidemic i.e. reducing the number of persons who could be exposed to the infection through the proposed key activities. the reduction of disease transmission is most efficiently conducted by socially distancing people from each other and reducing their contacts [ ] . additionally, educational campaigns which strengthen the understanding of the outbreak and adhere to mitigation strategies need to be conducted in order to raise awareness about the covid- disease and its consequences. some epidemics have the characteristic of rapid pathogen spread, which causes them with the high incidence of hospitalized and severely ill patients. emerging of an enormous number of patients, suffering from the disease which causes the epidemic, within a short period of time, can become a major problem for the whole healthcare system of a country especially with an emphasis on the secondary or tertiary protection level. even well-developed countries with the most sophisticated healthcare systems can easily experience the healthcare collapse during epidemics [ ] (e.g. italy [ ] , usa [ ] , spain [ ] , uk [ ] ). the primary healthcare system in such circumstances needs to undertake significant steps in early diagnosing of ill patients and reducing the degree of contact in order to avoid the collapse of secondary and tertiary level. besides engaging healthcare resources to combat the epidemic, the need emerges for an intensive use of it solutions. this paper presents the adaptation and extension of existing medical information system (mis) as an efficient response to the rapid covid- epidemic spread, mostly through influencing the reduction of social contacts and earliest possible identification of potentially infected persons. the objective of this paper is increasing the degree of social distancing (decreasing unnecessary physical contacts in a healthcare institution and city in general) which is accomplished by adapting the existing mis medis.net [ ] . the implementation of social distancing is based on the following relationships: patient to patient and patient to healthcare worker. the adjusted mis gave an efficient response to the rapid spread of pandemic caused by covid- . by adapting mis medis.net a software support is granted to the healthcare centre nis (hcn) to combat the j o u r n a l p r e -p r o o f fast-spreading disease covid- . the software support is provided to the following key proposed activities: , , , , . the novel coronavirus appeared by the end of and is named sars-cov- [ ] . it was discovered in china by the end of in the city of wuhan, the province of hubei [ ] . the disease caused by the virus sars-cov- is named covid- . for covid- the world health organization (who) assigned the urgent icd- diagnosis u . [ ] . since its emergence, covid- is the center of attention of many researchers. one recent study [ ] reviewed the virology, origin, epidemiology, clinical manifestations, pathology and treatment of covid- showed bilateral patchy shadows or ground glass opacity in the lungs [ ] . the covid- disease in most of the cases affects older men with comorbidities and can lead to severe as well as life-threatening respiratory diseases. the average age of these patients infected by new coronavirus in wuhan was . years (sd . ) and % of them had some chronic disease [ ] . the most vulnerable patients have chronic diseases such as diabetes, hypertension and cardiovascular disease with possible complications, which include acute respiratory distress syndrome (ards), rnaaemia, acute cardiac injury and secondary infection [ ] . the fig. shows the exponential growth of the affected and deceased people worldwide infected by covid- [ ]. due to prolonged lockdown and fear of infection, covid- adversely affect the mental health of the general the first case of the affected by the virus in the republic of serbia (rs) was recorded on march , . the exponential growth of patients affected by covid- is recorded in rs [ ] . the government of rs formed on april the covid- is [ ] . the aim of this is is to carry out epidemiological surveillance related to covid- . due to the exponential and easy spread of the highly contagious covid- disease, it was necessary to rapidly adapt the existing mis during the beginning of the covd- pandemic. due to the exponential growth of the covid- disease it is crucial to develop triage protocols in order to identify and isolate patients suspected of having the covid- infection in covid- temporarily hospitals or special departments in existing health institutions for the isolation of patients. in this way the disruption of normal medical care would be mitigated. a successful protocol for triage during a pandemic requires a more detailed planning, which involves a constant data collection: about the patient (demographic and medical data), data about availability of healthcare resources [ ] . a patient portal-based covid- self-triage and self-scheduling tool was created and it was made available to all primary care patients at the large academic health system at the university of california, san francisco (ucsf) health [ ] . based on the results, during first days of use symptomatic patient triage dispositions were as follows: emergent ( %), urgent ( %), nonurgent ( %), self-care ( %) and sensitivity for detecting emergency-level care was . %. according to the research findings the integration of patient self-triage tools into electronic health record (ehr) systems has a great potential in improving the triage efficiency and preventing unnecessary visits during the covid- pandemic. the estimate of effects of physical distancing measures on the progression of the covid- epidemic was conducted [ ] . synthetic location-specific contact patterns in wuhan were used and adapted in presence of school and workplace closures as well as the general reduction in mixing in the community. using an age-structured susceptible-exposed-infected-removed (seir) model the authors simulated the ongoing trajectory of the epidemic. they fitted the latest estimates of epidemic parameters and investigated the age distribution of cases. lifting of the control measures, such as allowing people to return to work in a phased-in way was also simulated. the effects of returning to work at the beginning of march or april were investigated. based on the results, physical distancing measures showed to be most effective if staggered return to work happened at the beginning of april, which reduced the average number of cases by more than %. the authors summed up that if restrictions maintained until april, they would delay the peak of epidemic. sudden lifting of measures could provoke an earlier secondary peak. such a scenario can be avoided by relaxing the measures gradually. the tools and methods developed for the identification of possible patients who suffer from some chronic disease show that the automatic summarization would help identify all patients with at least one record related to the diagnosis usually marked as chronic, with the final approval of medical professionals [ ] . the results show that depending on the data filter definition, the total percentage of newly discovered patients with a chronic disease is between % and %, as expected. it is important to mark chronic patients during the regular physician's visit during the covid- pandemic in mis medis.net since they belong to the vulnerable and high-risk groups. the use of smart technologies has been the focal point of many researches worldwide. especially in recent times the researchers are focusing on developing phone applications which track infected and potentially infected people in order to suppress the spread of covid- . the pan-european privacy preserving proximity tracing (pepp-pt) [ ] is a platform on whose development works a team of researchers from european countries. on the basis of this software national authorities remain free to decide how to inform persons that they were in contact with someone who was tested positive. world-renowned companies such as apple and google [ ] are developing a smartphone platform that tracks the spread of covid- by using proximity capabilities built into bluetooth low energy transmissions, which enables the actual tracking of physical contacts of phone users who agreed to participate. the user who is tested positive for covid- can enter the result into a health department-approved application. all other participating phone users who recently had a contact at the distance of approximately six feet with the infected user will be contacted by the application. during the largest ebola epidemic in west africa ( - ) researches developed an ebola j o u r n a l p r e -p r o o f contact tracing (ect) application for tracing contacts [ ] . the authors compared results of the application developed with the existing paper-based system. based on their research, the app-based contact tracing recorded % of contacts of laboratory-confirmed cases, whereas paper-based contact tracing achieved the result of % with often incomplete data. the developed smartphone application is linked to an alert central system to notify the district ebola response centre of symptomatic contacts. the authors agreed that despite many challenges the use of application had benefits, such as improved data completeness, storage and accuracy. the development of smart healthcare system is a highly important factor from the perspective of patients (e.g. better health self-management, timely and appropriate medical services can be accessed when needed), healthcare employees (e.g. reduce costs, relieve personnel pressure, achieve unified management of materials and information, and improve the patient's medical experience) and research institutions (e.g. reduce the cost of research, reduce research time, and improve the overall efficiency of research) [ ] . the researchers emphasized the importance of new generation of information technologies, such as internet of things (iot), mobile internet, cloud computing, big data, g, microelectronics, and artificial intelligence in order to build smart healthcare. furthermore, big data computational epidemiology is a new and exciting multidisciplinary area that uses computational models and big data for identifying and controlling the spatiotemporal spread of disease through populations (e.g. the h n influenza) [ ] . in today's era of informatization many health care institutions are facing the need to rapidly improve their it infrastructure to meet the challenges of modern times, such as the outbreak of covid- . the health facilities need to be prepared for the exponential growth of patients [ ]. on the territory of rs as mis several solutions are used among which are, during the last years, the most (table , table ), as well as the development of additional software modules, which help healthcare workers to proactively act in the suppression of pandemic. before the beginning of covid- pandemic mis medis.net did not have specifically developed software functionalities (modules, subsystems) which would help healthcare workers and patients to combat seasonal and exceptional pandemics. in the fig. due to the covid- pandemic the state service of covid- republic is [ ] was urgently developed and put smart ehr module enhances mis medis.net making it a more advanced version. one of the functionalities of the module is the clustering of patients based on the demographic and medical data by using the dnn [ ] . logistic regression [ ] , random forest [ ] and dnn are used for the implementation of subsystem for the smart identification and assessment of patients who will not come to the appointment with the chosen physician or/and to expensive diagnostic examinations for which a patient needs to wait, sometimes even for several months. this system has enabled patients to make appointments in overlapping slots [ ] during the covid- pandemic. for chronic patients [ ] during a pandemic, a special submodule is used which suggests to general practitioners a possible therapy with the amounts of a medicine and the periodicity of taking a medicine, as well as possible referrals for specialist examinations [ ] . due to the use of new medicines during the treatment of infected patients with the covid- infection, a subsystem is used as an assistance, which warns the physician whether the prescribed therapy corresponds to the established diagnosis. the subsystem also informs about the possible contraindications with other medicines the patient is using. a smart mobile reminder for taking the prescribed therapy [ ] helps elderly and chronic patients during the pandemic not to forget to take the therapy at the predefined time. the developed subsystem for the use of existing data from mis medis.net in the education of students at the faculty of medicine and newly employed workers, as well as for medical research [ ] , enables tracking and studying the covid- disease at this stage. open data service is used for obtaining the demographic data from available open data sets in serbia [ ] . scheduling module is responsible for recording scheduled/cancelled appointments of patients for an examination with chosen physicians/diagnostic devices. the centralized management of arranged checkup appointments and j o u r n a l p r e -p r o o f diagnostic procedures of patients was accomplished by integrating scheduling module with the service/application "moj doktor" is [ ] . mail notification modul is responsible for providing service information to patients and health center employees via email. sms notification module enables providing service information via sms [ ] . during the pandemic these modules were used for sending information to health care employees and patients. in order to receive updated demographic data for each patient during the pandemic reporting modul was connected to opendata available services of the rs [ ] . in the fig. and fig. a significant decrease of the arrival of patients during pandemic weeks at hcn is presented after the implementation of additional modules developed during the covid- pandemic. from the th pandemic week, the number of patients who received referrals for specialist examinations decreased notably (fig. ). out of all the patients who came to the hcn, the patients who were referred to specialist examinations were predominantly chronic patients. in most of the cases those were the patients with diagnosed i -essential (primary) hypertension and e -type diabetes mellitus. the reduced number of patients at the hcn also influenced the decrease in the laboratory referrals. the fig. . presents also the most frequent diseases for which prescriptions, referrals and laboratory orders were used. all the patients who visited the health center showing some symptoms of covid- went through the triage algorithm. despite the lower arrival of patients ( table ) the number of patients who were forwarded to the clinics of infectious diseases and pulmonology was higher in comparison with last years. taking into consideration that the number of arrivals of patients at hcn was in general reduced (fig. , fig. ), the increase of such referrals was significant. covid- as a significant manifestation had a rapid change of health condition on the lungs of a patient, j o u r n a l p r e -p r o o f so patients were after completing triage urgently referred to already mentioned external clinics for urgent further diagnostics. were patients who could be in home isolation, patients who were tested and not diagnosed with covid- , although they showed some infection symptoms or were in contact with infected or potentially infected persons. patients with a yellow priority had a clear picture of disease and were hospitalized in temporary covid- hospitals. patients with a red priority were confirmed covid- cases who also had some chronic disease and belonged to highly vulnerable groups (table ) . these patients were hospitalized and required constant monitoring. patients with a blue priority needed to be hospitalized and were directly transported from home to covid- hospitals. one the most significant decrease of arrivals of patients at the hcn was recorded during the th , th and th pandemic week. it was influenced by the developed modules which were distributed to the hcn as they were developed and adapted. the greatest decrease so far was recorded in the th week of (fig. , fig. ). during the th pandemic week the integration with covid- is was completed so patients started to significantly communicate online with chosen physicians. at the same time, the number of their arrivals at the hcn decreased, which means that contacts and the stay in the environment with high virus presence incidence were reduced. the age structure of patients who were coming the most during pandemic weeks was from to years of age were the data about the persons who were coming to physicians for examinations, during the period when the physicians were infected, and who were later diagnosed with the presence of covid- ( - days before registering the disease). these data were provided by covid- analyses, which can be accepted or denied by the physician. the authors argue that the ehr is a necessary tool in supporting the clinical needs of a health system during the covid- pandemic management. one of the limitations of this study is that the top chronic icd- diagnoses did not include psychiatric illnesses such as depression. psychiatric patients were deprived of psychiatric care and resulted in more severe levels of depression and anxiety during covid- pandemic [ ] . workers are reluctant to taking time off work to attend hospital/clinic during covid- pandemic [ ] and the mis medis.net may help them to book appointment. future research is required to extend the application of mis medis.net to psychiatric patients and workers. furthermore, mis medis.net can work with smartphone applications to deliver counselling [ ] , rehabilitation [ ] , support caregivers [ ] and monitor symptoms [ ] . since the coronavirus has potential for long lasting global pandemic with huge mortality rates and overloaded health systems, currently the only possible prevention is case isolation, contact tracing and quarantine, physical distancing, and hygiene measures [ ] . a key approach to avoid the exceeding of health care capacities is by successfully implementing social distancing as a measure to control the spread of covid- . in order to achieve this, prolonged social distancing might be required until [ ] . the the following contributions are made by the authors: -aleksandar milenkovic, dragan jankovic and petar rajkovic made initial design of system functionalities; -aleksandar milenkovic and dragan jankovic lead the system development and later deployment to the production environment; -aleksandar milenkovic and petar rajkovic extracted the data and performed analysis and data interpretation; -aleksandar milenkovic and petar rajkovic made a literature review; -all the authors made initial article draft; -all the authors revised and made a final approval of the submitted version. medical information system medis.net, whose usage overview is presented in the submitted work, is a result of a joint project of the laboratory of medical informatics and health center nis. as a commercial product, it is sold to other public health centers in the republic of serbia. aleksandar milenkovic and dragan jankovic received personal fees as full members of laboratory of medical informatics. during the conduct of this research, petar rajkovic received no financial compensation, but was allowed to use statistically processed data for other researches. this work has been supported by the ministry of education, science and technological development of the republic of serbia (project number: on ). j o u r n a l p r e -p r o o f use the real medical data for the research that is presented in this paper. the assistance provided by slavica cvetkovic for language editing and proofreading is greatly appreciated. what was previously known on the topic: -social distancing is one of the most significant measures in suppressing the spread of a virus during epidemics and pandemics (such as the current covid- pandemic). -initially, medical information systems were not created for the purposes of social distancing. -the adequate adaptation and upgrading of medical information systems can significantly increase social distancing by reducing patient to patient and patient to healthcare worker contacts. -by customizing the medical information system social contacts can be significantly reduced and the spread of the virus slowed down without severely disrupting people's lives. -the accurate triage is essential when there are not enough tests and when the laboratory capacities for samples processing are limited. j o u r n a l p r e -p r o o f infection prevention and control of epidemic-and pandemic-prone acute respiratory infections in health care, world health organization world health organization, covid- strategy update the global impact of covid- and strategies for mitigation and suppression immediate psychological responses and associated factors during the initial stage of the coronavirus disease (covid- ) epidemic among the general population in china is returning to work during the covid- pandemic stressful? a study on immediate mental health status and psychoneuroimmunity prevention measures of chinese workforce isolation, quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus ( -ncov) outbreak telehealth transformation: covid- and the rise of virtual care public activities preceding the onset of acute respiratory infection syndromes in adults in england -implications for the use of social distancing to control pandemic respiratory infections situation update worldwide what other countries can learn from italy during the covid- how coronavirus broke america's healthcare system, ft magazine lessons learned from the coronavirus health crisis in madrid, spain: how covid- has changed our lives in the last weeks coronavirus: london hospitals facing "tsunami" of patients, the guardian developing and deploying medical information systems for serbian public healthcare: challenges, lessons learned and guidelines escaping pandora's box -another novel coronavirus severe acute respiratory syndrome coronavirus (sars-cov- ) and coronavirus disease- (covid- ): the epidemic and the challenges emergency use icd codes for covid- disease outbreak, world health organization insight into novel coronavirus -an updated intrim review and lessons from sars-cov and mers-cov clinical characteristics of hospitalized patients with novel coronavirus-infected pneumonia in epidemiological and clinical characteristics of cases of novel coronavirus pneumonia in wuhan, china: a descriptive study clinical features of patients infected with novel coronavirus in wuhan, china, the lancet a longitudinal study on the mental health of general population during the covid- epidemic in china republic of serbia open data portal, covid infection dataset republic of serbia government, covid- government information system of the republic of serbia information technology systems for critical care triage and medical response during an influenza pandemic: a review of current systems rapid design and implementation of an integrated patient self-triage and self-scheduling tool for covid- the effect of control strategies to reduce social mixing on outcomes of the covid- epidemic in wuhan, china: a modelling study data summarization method for chronic disease tracking the "pan-european privacy preserving proximity tracing initiative" and guidance by supervisory authorities apple and google detail bold and ambitious plan to track covid- at scale, teetering on a razor, smartphone giants try to balance infection tracking and privacy use of a mobile application for ebola contact tracing and monitoring in northern sierra leone: a proof-of-concept study smart healthcare: making medical care more intelligent priorities for the us health community responding to covid- application of medical information systems in the republic of serbia -current status and possible improvements, in: information technologies -present and future state, it' , xx international expert meeting development of a triage protocol for critical care during an influenza pandemic electronic health records and technical assistance to improve quality of primary care: lessons for regional extension centers decision making and analysis web tool for medis.net medical information system deep learning techniques for biomedical and health informatics a novel classifier for influenza a viruses based on svm and logistic regression using random forest algorithm for breast cancer diagnosis optimization of health service schedule adaption of medical information system's e-learning extension to a simple suggestion tool health care domain mobile reminder for taking prescribed medications application of medical information systems in education and research in medicine republic of serbia government, republic of serbia open data portal republic of serbia government an implementation of sms communication with patients in a medical information system rapid response to covid- : health informatics support for outbreak management in an academic health system do psychiatric patients experience more psychiatric symptoms during covid- pandemic and lockdown? a case-control study with service and research implications for immunopsychiatry characterize health and economic vulnerabilities of workers to control the emergence of covid- in an industrial zone in vietnam online and smartphone based cognitive behavioral therapy for bariatric surgery patients: initial pilot study, technology and health care the untapped potential of smartphone sensors for stroke rehabilitation and after-care conceptualization of an evidence-based smartphone innovation for caregivers and persons living with dementia digital platforms in the assessment and monitoring of patients with bipolar disorder quantifying sars-cov- transmission suggests epidemic control with digital contact tracing projecting the transmission dynamics of sars-cov- through the postpandemic period the authors would like to offer their special thanks to all the staff at the laboratory of medical informatics at the faculty of electronic engineering in nis. the special thanks are extended to the health center nis for enabling the key: cord- -s iigb j authors: leones, louis mervyn b; berba, carlo miguel p; chua, alfredo v; sandoval-tan, jennifer title: caring for the carers: safeguarding oncologists’ mental health in the time of covid- date: - - journal: ecancermedicalscience doi: . /ecancer. . sha: doc_id: cord_uid: s iigb j taking care of patients with chronic, terminal diseases presents unique challenges to the mental health of medical oncologists. the current coronavirus disease (covid- ) pandemic has exacerbated these mental health risks brought about by isolation and exhaustion. delegated to be a national covid- referral centre, the university of the philippines—philippine general hospital faced many challenges, including the increased workload in a perilous and anxiety-inducing national crisis which placed the entire healthcare team in an unprecedented situation. to adapt to these challenges, the division of medical oncology employed the following measures to safeguard the mental health of its faculty and fellows: ) use of psychological support materials; ) initiation of a psychological intervention programme and ) establishment of peer support programmes. caring for the carers through evidence-based interventions ensures the delivery of quality care to our cancer patients despite the challenges during these trying times. the practice of oncology is often seen as heavy for the psyche. daily encounters with patients who have chronic, terminal diseases present unique challenges to mental health, possibly leading to burnout [ ] . this may be from the burden of making life-and-death decisions and unsatisfactory work-life balance in the face of an often limited ability to significantly prolong the life of most patients. when these issues go unaddressed, suicide risk is increased [ ] . however, studies focusing on how to address these issues particularly among oncologists are limited [ ] . the coronavirus disease (covid- ) pandemic has exacerbated the mental health risks of physicians. as seen in the severe acute respiratory distress syndrome (sars) experience, psychological distress, fear, anxiety and post-traumatic stress symptoms have profound impacts [ ] . on top of concerns of risk of infection, physicians also face additional stressors such as isolation and exhaustion [ ] . they were noted to have a higher risk of depression, anxiety, insomnia and distress [ ] . these effects are related to the physicians' department and occupation [ ] . how these specifically apply to oncologists, however, is yet to be known. starting march , the university of the philippines-philippine general hospital (up-pgh), the , -bed national university hospital, has been delegated to be a national covid- referral centre. several changes ensued, including limiting elective admissions and a neartotal temporary closure of outpatient services. the cancer institute, however, remained operational while working on a skeleton workforce. because of the conversion of various areas into new covid- wards, medical personnel were transferred temporarily to augment manpower in these areas. this increased workload put the entire team in an unprecedented situation. to adapt to the situation, the division of medical oncology employed the following measures to safeguard the mental health of its faculty and trainees: use of psychological support materials support materials were provided both online and offline. the university's information office has published healthscape, a weekly covid- newsletter. in its fourth issue, it outlined the hospital's endeavors including projects like resiliency wall, a closed group page for information dissemination and discussion of covid- -related issues; psychosocial care posters with infographics; and heroes' heroes, an initiative that aims to collect thank you cards and words of encouragement for health workers [ ] . recommendations from the philippine council for mental health are also available in the hospital's social media page. recognising the role of therapist-driven sessions [ ] , the division collaborated with the department of psychiatry for a psychological intervention programme. an online survey was conducted to identify self-perceived mental health status and issues. twelve of the fellows answered standardised questionnaires on anxiety, depression and burnout. participants reported that the seriousness of the disease and the current situation coupled with the responsibility of taking care of cancer patients contributed to the anxiety felt, especially when on duty at the covid- areas. internal strengths and resources identified that could help were the good support system between the faculty and trainees, and guidance on how to manage issues arising from this crisis. one major limitation is the limited access to funding resources for cancer patients because most funding agencies, both government and private, directed their funds to covid- -related interventions. a psychiatrist then conducted regular group sessions via an online meeting platform. digital technologies provide a range of mental health interventions [ ] . separate meetings were held for the first-year fellows, second-year fellows and faculty to ensure an avenue for the safe discussion of possible issues and challenges that they were facing. processing of their psychosocial reactions was done, and coping strategies were explored. their mental readiness to continue with the division's activities was also assessed. sixteen of the oncologists participated. the psychosocial reactions expressed were similar among the groups. anxiety and fear were predominant themes, consistent with the results of the survey. they expressed fear for their safety, specifically about the possibility of contracting the disease, their families' and co-workers' safety, and the well-being of their patients. in particular, the new first-year fellows expressed doubts about their capacity to perform their tasks satisfactorily, especially at the covid- areas, because of their unfamiliarity with the new set-up. an important internal factor which helped with coping was their strong sense of responsibility as doctors and members of the community. this gave meaning to their role despite the uncertainties of the situation. their strong sense of group spirit with the mindset that the crisis is a shared burden also helped. the concrete and visible safety efforts implemented by the hospital, help from various organisations, and consistent efforts of the division to check on each other's well-being were some external factors which allayed anxiety. other coping mechanisms include staying connected with family and friends, being productive and engaging in enjoyable activities. with these findings, the department of psychiatry deemed the oncologists to have appropriate psychosocial reactions. emotional and cognitive coping mechanisms were employed and were adaptive to the stresses of the pandemic. thus, they were assessed to be mentally ready to continue with the divisions' activities. peer support programmes were in place. colleagues and immediate supervisors provided emotional and psychological support [ ] . at the start of the training programme, faculty members were assigned trainees whom they would mentor. during the pandemic, this coupling was utilized as a means of top-down emotional support. mentors and mentees would have weekly virtual meetings, where the faculty could process pertinent events during the week and identify any issues among the trainees. these meetings provided the oncologists a structured psychological safety net and a venue for the discussion of clinical issues that may arise during the delivery of cancer care. colleagues also contributed to the supportive environment by participating in a buddy system, where each junior fellow was paired with a senior. they would often be assigned together during hospital duties and assignments. although less structured than a mentor-mentee system, this provided immediate support in a more collegial environment. the long-term effects of these ongoing interventions are still to be evaluated. periodic evaluation by the department of psychiatry in the form of regular scheduled meetings and answering of standardised questionnaires on anxiety, depression and burnout is continued. should the nationwide pandemic start to ebb, the terminal component of this support programme will be evaluated by group and individual interviews, as well as monitoring trends in anxiety, depression and burnout. the pressing need to ensure that the mental health needs of medical oncologists are met in an unprecedented time like this cannot be overemphasised. although challenging, mitigating the negative psychological impacts of being an oncologist is vital in winning against covid- . caring for the carers through evidence-based interventions ensures the delivery of quality care to our cancer patients. addressing depression, burnout, and suicide in oncology physicians psychological impact of severe acute respiratory syndrome on health workers in a tertiary hospital the psychological impact of the sars epidemic on hospital employees in china: exposure, risk perception, and altruistic acceptance of risk factors associated with mental health outcomes among health care workers exposed to coronavirus disease sars control and psychological effects of quarantine psychosocial care for covid patients and their families healthscape: special covid issue intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial the lancet commission on global mental health and sustainable development who do military peacekeepers want to talk about their experiences? perceived psychological support of uk military peacekeepers on return from deployment on behalf of the division of medical oncology, the authors would like to thank the up-pgh department of psychiatry under the leadership of their chairperson, dr anselmo tronco, for the collaboration in doing the psychosocial intervention programme for oncologists. the authors declare that they have no conflicts of interest. no funding was received for this work. key: cord- -xad zht authors: kumaravel, santhosh kumar; subramani, ranjith kumar; jayaraj sivakumar, tharun kumar; madurai elavarasan, rajvikram; manavalanagar vetrichelvan, ajayragavan; annam, annapurna; subramaniam, umashankar title: investigation on the impacts of covid- quarantine on society and environment: preventive measures and supportive technologies date: - - journal: biotech doi: . /s - - - sha: doc_id: cord_uid: xad zht the present outbreak of the novel coronavirus sars‐cov‐ , epicentered in china in december , has spread to many other countries. the entire humanity has a vital responsibility to tackle this pandemic and the technologies are being helpful to them to a greater extent. the purpose of the work is to precisely bring scientific and general awareness to the people all around the world who are currently fighting the war against covid- . it's visible that the number of people infected is increasing day by day and the medical community is tirelessly working to maintain the situation under control. other than the negative effects caused by covid- , it is also equally important for the public to understand some of the positive impacts it has directly or indirectly given to society. this work emphasizes the various impacts that are created on society as well as the environment. as a special additive, some important key areas are highlighted namely, how the modernized technologies are aiding the people during the period of social distancing. some effective technological implications carried out by both information technology and educational institutions are highlighted. there are also several steps taken by the state government and central government in each country in adopting the complete lockdown rule. these steps are taken primarily to prevent the people from covid- impact. moreover, the teachings we need to learn from the quarantine situation created to prevent further spread of this global pandemic is discussed in brief and the importance of carrying them to the future. finally, the paper also elucidates the general preventive measures that have to be taken to prevent this deadly coronavirus, and the role of technology in this pandemic situation has also been discussed. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. an unprecedented outbreak of mysterious etiology pneumonia, which occurred in december , has taken the whole world to a state of sorrow and worry about the future. the novel coronavirus (covid- ) is a respiratory illness and its outbreak primarily originated from wuhan, china. the epidemic is found to be caused by a zoonotic transmission event associated with a wide seafood market and soon became transmission from human to human (zhou et al. ). mostly the virus affects animals only, but the covid- virus is able to mutate into new forms that are immune to the vaccine. despite various efforts taken by every country like global containment, travel restrictions, and treating the infected person, the incidence of covid- continues to rise at a tremendous rate. at the same time, the lockdown has also made some impacts on human society such as negative psychological effects due to quarantine, loss in the economy of the world. but there are also positive aspects like reduction in pollution due to less movement of vehicles and closure of many industries. covid- is identical to coronavirus with severe acute respiratory syndrome (sars) and coronavirus with middle east respiratory syndrome (mers). this is also known as coronavirus (sars-cov- ) severe acute respiratory syndrome pneumonia. it's confirmed that the sars-cov- ( fig. ) originated by nature itself by comparing the available genome of the coronavirus strains said by kristia andersen, ph.d., an associate professor of immunology and microbiology at scripps research (science daily a). coronavirus is a big family of severe respiratory illness, first it was found in at china as sars and its second outbreak occurred in in saudi arabia as mers (science daily a). the coronavirus with spike protein-rbd (receptor binding domain) portion is the important part of the virus that has been evolved and binds to the cells and then cleaves the site of contact where the virus enters the human cells (science daily a). the articles revealed that the covid- is a group of beta-coronavirus and this is mutated from bat coronavirus hku - which is the ancestor of covid- . this mutant virus interacts strongly with the human ace receptor. the researchers state that the sars-cov- shares less than % nucleotide identity and has . % similarity genes of the previous sars-cov (qamar et al. ) . the transmission of sars-cov- is presented as in (fig. ) . the genome of sars-cov- is . % similar to the bat cov ratg and shares its identity from sars-cov . it is known that the main cause of this virus has started from bats and the virus is mutated to affect the humans and it is identified that there are six coronaviruses which affect the human body and some of them are α-covs hcov- e and hcov-nl , which are of low pathogenicity and cause mild respiratory symptoms. the covid- is a respiratory disease that spreads at a maximum rate through droplets of the infected people through the air (world health organisation a). the coronavirus is mutant by the previous process; it has been continuously spreading between the humans, rapidly through many modes of transmission they are as follows: • cough or sneeze by the infected person. • through close contact with the victims by touching the nose, eyes, and mouth. • the transmission of droplets occurs within m. • the transmission can also happen by indirect means such as handling the instruments of the infected person, for example, stethoscope, thermometer (world health organisation a). the affected persons were observed with common symptoms like cough, fever and in addition to it, some were noticed by muscle soreness, headache, dyspnea, and fatigue. thoracic radiology and ct (computed tomography) are the best evaluations of the infection covid- (bernheim et al. ) . also, most of the positive cases are asymptomatic, they are not aware that they are carrying the virus to spread it on. the world statistics of infected cases increased to , , , total deaths climbed to , , , and recovered cases were , , by th july (worldometers a) . in india, the total number of cases was , , , death cases were , and the recovered cases were , , as on july th (worldometers, a) . the fatality rate on july th, was estimated to be . % and it is calculated by (total deaths/(death + active cases)) (qamar et al. ) . the observed spread of covid- is more rapid than the calculated values. the number of death cases all over the world increased about times from march th till march th from deaths to , death cases(see fig. ). covid- is a deadly disease that had no mercy on the pregnant women and even the infants inside the womb of the mothers during this pandemic. the who (world health organisation) has said that the covid- affected pregnant women may die due to the infection and may spread the disease directly to the foetus and neonate. after testing the affected women who gave birth to infants, the reports state that the babies were healthy and the women were tested negative for the virus after various effective treatments . the infected patients were given chloroquine phosphate to block the covid- infection in low micromolar concentrations. china has tested the safety and efficacy of the chloroquine that can be used to treat covid- in ten hospitals . the reproductive rate of covid- is ranging from . to . and the average reproductive rate is . and the estimates were calculated by different personnel in different methods (liu et al. a, b) and in india, the reproduction rate of coronavirus is estimated to be . (india's covid- ro value ). the purpose of this review is to convey the impacts on society due to the pandemic and also how to tackle this pandemic situation with the available technologies. this review shares the knowledge about the technologies that help out the industrialists, students, and doctors to fight against and run the routine life even during the lockdown. this review would also elucidate the environmental impacts that changed the world during the quarantine of the people and the preventive measures taken by the governments for the safety of the people in the world. in this review, the knowledge regarding the importance of quarantine and social distancing is gathered first. statistics obtained from who and worldometers is used for this review to demonstrate the quarantine effect. then, it discusses the social nature of the disease. statistics on the fatality incidence derived from standard research articles have also been used here. also, the environmental effects related to the epidemic were discussed in a detailed manner. data on the condition of air quality and bird status during the lockdown scenario is obtained from online reports and journal articles. the preventive measures for covid- were also discussed. data is also obtained based on the equipment used during the lockdown process. the knowledge obtained from academic or grey literatures were helpful to carry out this comprehensive analysis. a keyword search based method was used to collect the information along with a structured process of sorting the data. in the beginning, the keywords are made to be determined through detailed discussions. the keywords used for searching the data are covid- , environmental impacts, technologies, pollution, and quarantine. the academic literatures discussed in this work here comprises of regular papers and conferences while the grey literatures discussed here contain web sources and professional studies. this analysis took google scholar, scopus, and scopus indexed extended as the most important research sites for framing the important sections of the work. when gathering the data and details, we ensured that only the peer-reviewed publications and online sites to be referred to. for this review, about articles and official web resources were studied. the articles were further reviewed to identify the most suitable papers for this analysis. finally, references from scholarly journals and references from web resources, a total of references found to be the most suitable for this work, and those were included in this review analysis. when reviewing the relevant papers, a manual procedure is followed to determine the appropriateness of the papers for this study. the systematic framework for data collection adopted in this review paper is shown in (fig. ). the spread of covid- disease was announced by the world health organization (who) as a public health emergency of international concern on th january (world health organisation b). there are currently no appropriate treatments and vaccines for this virus (wilder-smith and freedman ). also, evidence shows that much of the human to human transmission occurs during covid- ′s asymptomatic incubation interval, which will be approximately between and days (rothe et al. ; sohrabi et al. ) . therefore we rely entirely on public health strategies such as quarantine to restrict the spread of this respiratory disease. quarantine essentially involves isolating or limiting the mobility of people who have come from other countries or have been exposed to this infectious disease. in this scenario, covid- infected persons are isolated from non-infected persons and this isolation usually takes place in the hospital. by quarantine, we can prevent the human-to-human spread of disease to break the chain of transmission (wilder-smith and freedman ). quarantine facilities must be provided to infected persons who do not have an appropriate homely environment (cetron and landwirth ) . but the infected patients would also be able to transmit the disease to another person before the symptoms appear to them. the incubation time for the covid- has a median of days . so quarantine is often too late to effectively stop the transmission and control this influenza pandemic (wilder-smith and freedman ). thus, it remains unknown when the transmissibility attains its peak and how frequently pre-symptomatic cases get transformed into secondary cases. quarantine was implemented successfully to halt the transmission during the sars epidemic in (goh and chew ) . it is one of the important steps in this pandemic disease plan. the quarantine can be done to an individual or at the group level and usually, it involves restriction to the home or a particular area. during the quarantine period, all the persons should be monitored regularly for the occurrence of any symptoms. if any symptoms occur, the infected individual must be immediately isolated in a designated place with all essential treating equipment. by quarantining, the detection of cases becomes easier, so that contacts can be listed and traced out within a short period of time frame (wilder-smith and freedman ). also, quarantine includes the following benefits: • the isolation of persons prone to reported cases will avoid a large proportion of diseases and deaths relative to those without control. • there was little impact of quarantining travelers from a country with a reported epidemic to prevent infection and death. • in addition, the incorporation of lockdown with other treatment and prevention measures such as school closures, travel restrictions, and social distancing has had a greater impact on spread prevention, cases requiring critical care beds, and deaths compared with quarantine alone. so in controlling the covid- outbreak, more systematic and early implementation of preventive and control measures may be more successful (science daily b). after an effective lockdown of months, the cases in china were reduced. this can be clearly viewed in fig. . it gives a clear overview of the covid- attack and how china resolved its pandemic situation. when covid- cases are increasing rapidly all over the world, china had got slowly relieved from this infectious disease with its severe methodologies and treatments. this also shows the effect of massive lockdown in mainland china. chinese health (worldometers b) authorities have declared that the country had passed the peak of coronavirus outbreak on march th, (impact of lockdown in china ). another component to prevent transmission is 'social distancing'. this must be introduced to minimize people-topeople communication in a larger population, where individuals may be contagious but have not yet been recognized as an infected person and therefore not isolated. so social distancing of people will effectively reduce the transmission of this kind of infectious disease (wilder-smith and freedman ). this involves avoiding unnecessary travel and social gatherings. there must always be a m gap between people in public, independent of viral transmission (social distancing in uk ). social distancing is useful where community spread is suspected to have occurred, but where the relationship between the infected persons are uncertain and restrictions imposed only on individuals known to be exposed are considered inadequate to prevent further disease transmission (centres for disease control and prevention ) . social distancing includes closure of schools or office buildings, public markets, and the cancellation of gatherings. community-wide isolation is an initiative extended to the entire city, town or area to restrict human interactions, except for limited interactions to ensure that vital resources reach human beings. in the absence of medicinal drugs for this covid- disease, the only solution is that by reducing the contact of affected people and the things used by affected people are to be totally avoided (lewnard and lo ) . but implementing community-wide containment is far more complex because it involves a large number of people (rothe et al. ) . it is important to use social media wisely during community-wide containment, which provides us with an opportunity to communicate the reasons for quarantine, to provide realistic advice, to avoid misinformation and getting panic. the implementation of the above mentioned public health initiatives also includes cooperation with law enforcement officials at local and state level, and it involves checkpoints and may need legal penalties if quarantine violations occur (rothe et al. ) . a community-wide containment is currently happening in america. quarantine is one of the unpleasant experiences for those who undergo it. since quarantine includes separation from loved ones, loss of rights, confusion about the status of disease and boredom can have drastic effects (brooks et al. ). this quarantine period can extend for an unpredictable long time. the possibility of psychological and mental problems increases due to quarantine (xiao ) . the psychological negative effects include symptoms of post-traumatic stress, uncertainty, irritation, disappointment, insufficient knowledge, financial loss, and stigma. studies show that post-traumatic stress in children who are quarantined is found to be four times higher than children who were not quarantined (brooks et al. ) . many who are quarantined often experience a great degree of psychological distress and signs of disease. also due to lockdown in several countries across the world, the production of several essential commodities has been decreased. consumer goods companies are facing various problems like the absence of labour, stranded trucks, and permissions for manufacturing products (drop in production of essential goods ). the government has taken several measures to make the people stress-free. they are arranging the markets to nearby places. they are allocating funds to the poor people who are depending on money for food. they are taking several actions to make this quarantine not affect people's minds. throughout the outbreak of communicable diseases such as covid- , the limitations placed on daily behaviours as part of social distancing requirements to avoid the disease spread. the immediate response should include maintaining community shelters and community kitchens, supplying other relief supplies, stressing the need for social isolation, reporting the cases of infected people, and adhering to guidelines for treating these cases. it is significant to remember that isolation doesn't just freeze your brain with boredom. when people like those kept in solitary confinement, know their sentence is nearly up, their mood lifts again in anticipation. those who experience social isolation because of covid- can no longer get it. open, clear, and reliable connectivity is what governments and organizations should achieve the most (prem et al. ) . protect yourself, and help other people. helping others in their time of need will benefit both the individual who receives assistance and the helper. managing your mental health, psychological, and social well-being during this period is just as essential as managing your physical health. keep regular routines and schedules including regular exercising, cleaning, daily chores, singing, painting or other activities. individual approach to each other can cause significant social disruption, it is necessary to know the degree of intervention which is required to minimize transmission and the burden of disease (lewnard and lo ) . people who are living together can share many ideas to prevent this disease and also they can care for each other during this quarantine. at the same time, they should also take care of elderly people. in joint families, people will share the financial burden during this situation. they can also play with the children and always keep them engaged without feeling their loneliness. people must be sanitized and should maintain hygiene by periodically washing their hands with soap and water for at least s. ensure that your home and workplaces are regularly cleaned and sprayed with a disinfectant, with particular attention to electronic devices. there is currently no vaccine or antiviral drug for coronavirus in humans and animals. so it is important to be healthy during the -ncov quarantine period (lu ) . symptoms of prodromal -ncov infection include nausea, dry cough and malaise are non-specific (wang et al. a, b, c) . through not exchanging personal things like food, water bottles, and utensils. families can implement these improvements now. people can also use a separate room in your home that can be used to isolate the affected member from the safer ones. affected people must use a separate bathroom. in case your caretaker is sick, it is important to have the one who is really very healthy. caregivers and their care recipients will be required to work closely and also ensure that they will not be affected by covid- . the caregiver will monitor the situation and regularly inquire about the wellbeing of the other tenants (rocklöv and sjödin ). the outbreak is predicted to spread among larger sections of the society than the mers-cov (yoo ) . in this period people must utilize their time to gain knowledge by reading books via the internet. because of the coronavirus outbreak, the technology and industry have become their new best friend for people hunkering down, with a number of lifestyle options that make "social distancing" easier. many of them wish to avoid crowds; they can have restaurant meals delivered, socialize online with friends, and work remotely. lifestyle approaches inspired by the latest technologies to gain momentum as more people are motivated to work from home, as more conferences and events are cancelled. many online streaming platforms have gained more users, as people are feeling very bored during this quarantine (increase of online usage ). internet usage has been increased; more people are using mobile phones to watch the news as it is very handy and portable. to make this quarantine useful online classes were launched, which has let students learn from home and gain information. nowadays, children are great at surfing and browsing the data. they are learning to play games and handle mobile phones at a younger age. this will be useful if they are acquiring knowledge but at the same time, many inappropriate content can misguide their path. so parents must watch their kid's daily activities (web safety for kids ). they love to play online games because they cannot play outside during this quarantine. children can use the same internet for their self-development. various videos are available on the internet platform to develop their skills (omar et al. ). the internet is a blessing to the present generation as it was not available to the previous generations. it is based on how people are using the internet whether it is to be treated as a blessing or curse. the same internet is considered as a blessing in disguise as it helps people. without the internet, people will get mentally weakened by facing the four walls during this quarantine. as a result of the covid- calamity, the trend in social media has grown, with more people going online to remain linked to families, friends, and colleagues. recent research from kantar's insights and advisory company shows just how many advantages those applications gain. according to a survey conducted between and th march with more than , customers in markets, whatsapp is the social media application that earned huge attraction from the covid- perspective (rapid increase in web usage ). people are continuously using whatsapp during this quarantine. as people are required to communicate with their relatives who are in distant places they are using different kinds of communication mediums. its handling capacity has risen from an initial % rise in the earlier days of the pandemic to % in the mid-phase. whatsapp handling has increased by % for countries now in the later phase of the pandemic (rapid increase in web usage ). fatality rates were calculated by dividing the total number of deaths in persons who tested positive for sars-cov- (numerator) by the total number of sars-cov- cases (denominator) and this is expressed as a percentile in both ( fig. ) and (fig. ) (outbreak of covid- ). when societies prepare for potential covid- diseases, regardless of underlying health problems, the risks of older people and those with weakened immune systems need to be remembered. from this figure, we come to the conclusion that people with greater than or equal to years of age had the highest fatality rate ( . %) than all the other age groups. such type of people are at higher risk of severe covid- infection or even death. since fatality and extent of illness have a connection with the age factor and comorbidities from (fig. ) and (fig. ) , we must make sure that these high-risk groups of people have sufficient protection from infections and they should be subjected to early access to medical care when infected. these measures are important for improving their chances of survival (outbreak of covid- ). fatality rates were calculated by evaluating n = , it was found that confirmed cases in mainland china in both ( fig. ) and (fig. ) as of february th, (outbreak of covid- ). patients with no comorbid conditions had just . % of mortality, whereas patients with comorbid conditions had much higher rates. so it is found that people, who are older, with higher sequential organ failure assessment (sofa) score and elevated d-dimer at admission, were at high risk for death due to covid- (zhou et al. ). the case fatality rate is considered as a great tool to express the fatality rate (spychalski et al. ) . covid- infected persons are identified by reverse transcriptase polymerase chain reaction (rt-pcr) testing. this method is used to test the patients on the throat swabs (onder et al. ). but it is reliable only in the first week of covid- disease because after the first week it slowly starts to disappear on the throat and begins to multiply in the lungs. after the second week, the suction catheter is used to collect samples from the deep air breath of the affected person. due to this pandemic covid- spread, this transition has brought some unforeseen consequences in the environment. compared to the last year, emission rates in many countries have fallen gradually. this shows how the environment is affected by regular day to day activities. this is considered as one of the best positive impacts of the quarantine during covid- . so the environmental impacts of covid- are seen in various forms of pollution, the condition of birds and animals, and the disposal of harmful medicinal waste. the coronavirus outbreak had led the world to shut down many cities, companies, and industries to ensure the safety of the workers. this had a great impact on the environmental changes in the quality of air, water bodies, etc. cleaner air has saved several lives in the last few months. there was a decline in the level of air pollution because of countries that are imposing strict quarantine and travel restrictions, the unintended decline in air quality from the virus outbreak is only temporary (british broadcasting council ). the long-term impact of the coronavirus pandemic on the world will depend on how countries respond to an economic crisis. at the end of november , delhi, a city in india was found to have a bad or unhealthy quality of air. data intelligence unit (diu) reviewed the central pollution control board (cpcb) and the aqi (air quality index) bulletin of delhi. the -h average aqi (november rd, pm to november th, pm) showed that jind in haryana had analysed the most polluted air in cities. the average aqi at jind was and aqi of delhi was at (polluted cities ). during the period of quarantine, the air quality of delhi increased drastically and the aqi dropped to from , this shows that the environment has a good impact due to the coronavirus outbreak (improvement of air quality ). as the vehicle's movement has reduced during this quarantine, horn usage also decreased. generally, unnecessary horn sounds will irritate people. this has reduced very much. birds' sounds are heard more than any other sound during this lockdown. birds are enjoying nature on their own by tweeting and chirping (natural effect on this pandemic ). sound which is unnecessary and higher than the audible frequency level is considered as noise. the entire city soundscapes are reduced, which may be pleasant to all the living creatures. the noise reduction helped the people who have high blood pressure and the disruption in sleep. many people started to recall their peaceful childhood days because at that time vehicles were less (natural effect on this pandemic ). due to the shutdown of industries, the noise level has reduced to a great extent. if we follow the standards of transportation and reduce unnecessary noise, we can make this globe a pleasant and peaceful place to live in the near future too. water pollution has also decreased much, this will lead to an improvement in the purity of freshwater sources. the famous water bodies such as ganga and yamuna in india have seen much improvement in freshness and its purity during the lockdown of the entire country (impact on water bodies). these rivers are the two important freshwater sources, these should be protected. freshness and purity should be maintained (water quality improvement during the lockdown ). due to the reduction in transportation of oil and goods via oceans, the chances of pollution of water like spilling of oils and waste into the ocean is reduced. (effects of water pollution ). many countries now have biomedical waste management regulations, the central pollution control board (cpcb) guidelines have been issued to ensure the scientific disposal of the waste generated while people research and treat covid- patients. biomedical waste is created during diagnosis, care, immunization of humans, animals or research, etc. (biomedical waste regulations ). biomedical waste disposal regulations show how the waste produced during human diagnosis, treatment or immunization should be disposed of (hegde et al. ). the waste consists of human skin, blood-contaminated products, body fat, and blood or body fluid pollution of the bedding. sacks of blood, needles, syringe or all other sharp items infected (hegde et al. ). for isolation wards in which covid- patients are quarantined, it is noted that double-layered bags can be used as a precaution to capture waste in addition to regulations on biomedical waste to ensure adequate intensity and no leakage (guidelines for waste disposal ). across a number of nations, when quarantine roll calls, people will spend more money on movies, social media, drama, and books. nonetheless, nature does its thing and the people are experiencing an unforeseen quarantine result. in countries such as japan, italy, and thailand, animals were observed roaming in the streets because of human absence. due to quarantine both the birds and animals are feeling free to roam outside, the roads are completely empty there is no rush as normal days. it is considered as the natural environmental change for both the birds and animals (freedom of animals ). manufacturing products use energy and natural resources which creates pollution and waste production, some wastes like plastic bags and bottles in rivers, lakes which lead to negative consequences for endangered species and other animals. now due to the covid- pandemic situation birds and animals are feeling completely happy (freedom of animals ). although there are no exact vaccines for treating covid- as of now, some methods of treatment or antiviral drugs have been effective in curing the patients. so to get rid of quarantine or to get discharged from hospital, the following conditions have to be met: • body temperature is supposed to be normal for longer than days. • it is important to strengthen the body and overcome respiratory symptoms. • the radiological abnormalities or acute exudative lesions on chest computed tomography (ct) images must be enhanced to a greater version. • two consecutive results of rt-pcr (reverse transcription-polymerase chain reaction) should be negative and these results must be at least h apart (lan et al. ; pan et al. ). no medicinal drugs have yet been proved safe and effective for the covid- diagnosis. a variety of medicinal products have been proposed as possible research therapies, some of which are currently being tested in clinical trials during this pandemic situation which are cosponsored by who and other participating countries (world health organisation b). (table ) provides common and potential antiviral drugs. in some countries, doctors are treating covid- patients with drugs that were not approved for this disease. the use of licensed drugs for indications that are not approved by a national regulatory authority for medicinal products is marked "off label" use. table represents some of the common and potent antiviral drugs used in clinical practice previously for some of the diseases. medicinal drugs prescribed by doctors for off label use may be subjected to national laws and regulations (world health organisation b). both healthcare staff should be aware of the laws and regulations regulating their practice and comply with them. in addition, the stipulation should be made on a case-by-case basis. it is necessary to avoid excessive stockpiling and creating shortages of approved medicines that are needed to treat diseases. based on the past experience of battling the sars-cov and mers-cov outbreaks, we have discussed certain prevention approaches against covid- . chloroquine is one of the drugs tested in china for covid- . it was reported on february th, , to inhibit sars-cov- in vitro. national health commission of the people's republic of china, included this drug in the covid- treatment guidelines on february th, . according to this guideline, the recommended dose for adults is about mg twice per day and it should not be continued for more than days (wong et al. ) . also, for adults, g of chloroquine becomes lethal (riou et al. ). chloroquine is a repurposed drug that is very effective in the treatment of covid- . chloroquine is previously used as an antimalarial and autoimmune disease drug. this drug has now been identified as a possible antiviral drug of broad range (wong et al. ). this drug acts as a novel class of autophagy inhibitor, which prevents further viral replication. also, a combination of remdesivir and chloroquine was found to be effective in the treatment of covid- . hydroxychloroquine which is an analogue of chloroquine has been found to have an anti-sars-cov activity. it is also found that azithromycin added to hydroxychloroquine was found to be more efficient for eliminating the virus. the study revealed a higher proportion of people diagnosed with hydroxychloroquine and azithromycin relative to patients treated with hydroxychloroquine alone (gautret et al. ). the kabasuraneer choornam is a siddha medicine that is used to cure many types of fever, flu, and respiratory illness (ayurveda benefits ). it is specially used when there is table common and potent antiviral drugs goldhill et al. ( ) fever associated with cold, cough, and difficulty in breathing as it is used for treating various cases of flu (ayurveda benefits ). the kabasuraneer choornam contains nearly types of medicinal herbs and they are chukku (dried ginger), thippili (piper longum), cirukancori ver (tragiainvolucrata), seenthil (tinospora cordifolia), karpooravalli (anisochilus carnosus), lavangam (syzygiumaromaticum), adathodai ver (root of justiciabeddomei), korai kizhangu (cyperus rotundus), kostam (costus speciosus), akkara (anacyclus pyrethrum), vatta tiruppur (sida acuta), mulliver (hygrophila auriculata), nilavembu (andrographis paniculata), kanduparangi (clerodendrum serratum) and kadukkaithol (terminaliachebula) is found to be efficient in prevention and treatment of swine flu (natural remedies to treat swine flu ). the kabasuraneer choornam is prepared from the extract of kabasura kudineer choornam, it is added to water and heated to about - ºc till the water reduces to / th of the volume. the kabasuraneer choornam is a siddha medicine practised in india and mostly in southern india which is prescribed to increase the immunity against swine flu in (saravanan et al. ) . atleast eight of the herbs used in the preparation of the kabasuraneer choornam could neglect the replication of the virus and gives protection for the human body from covid- , said by sanjeev biomedical research centre (benifits of kabasura kudineer ). phytocompounds bind to the coronavirus spike protein or surface protein and prevent it from binding to the human cell membrane receptors that serve as a barrier until it starts to replicate. if the kabasuraneer choornam is consumed before the virus is contracted, the phytocompounds will bind to the respiratory epithelial cells and strengthen the immune system and it also prevents the virus from linking with the human cells and replicating after the person gets affected by covid- . the benefits of kabasuraneer choornam includes several phytochemical components that are responsible for antiinflammatory, antipyretic, analgesic, antiviral, antifungal, antioxidant, hepato-protective, anti-diabetic, anti-asthmatic, immunomodulatory, anti-diarrhoeal activity (saravanan et al. ) . it is said that the kabasuraneer choornam can be used against the covid- virus by siddha practitioners in india because it is a preventive remedy against various types of fever, flu and also increases the immunity of the human body (ayurveda benefits ). however, a siddha practitioner, g. sivaraman director of arogya healthcare said that this drug cannot be used as treatment for covid- and this drug is used to treat pneumonia like diseases in siddha medicine (remedy given by siddha field ). astrazeneca has joined serum institute of india (sii), the world's biggest immunization makers by the number of portions created and sold, to deliver the possible antibody in india. the human trials of oxford covid- immunization have just begun in brazil. if any of these vaccines have proved its success, then we can slowly reduce this pandemic to a normal situation (research updates on the vaccine ). some of the developers of vaccines that are in the clinical evaluation stage as on th july, are shown in (fig. ). in this section, the preventive measures for both people and medical staff given by central governments from the world health organisation will be elucidated. preventive measures should be taken otherwise, the risk of disease transmission will be more. according to the english proverb "prevention is better than cure", prevention is the best thing that we can follow, until the proper medicine or vaccination is found. the preventive measures that can be adopted to prevent human from getting covid- infection, they are as follows: • hygiene should be maintained. • % alcohol-based hand rub, liquid soap can be used by people. • avoid touching each other and maintain social distancing for m. • stay home, seek medical attention if you have the symptoms of cold, fever, and problems in respiration. follow the guidelines of the local health authority. • personal protective equipment [ppe] such as sterile gloves, face shields, aprons, sterile gloves, gowns, protective goggles, scrubs, masks (n or ffp ) must be used by medical staff. (adams and walls ). • medical staff and paramedical workers should self-quarantine themselves for alternate weeks. • doctors should sterilize themselves before and after attending the patients. • reducing the contacts with the family members during the crisis. • screening people and risk assessment should be well planned and managed. • environmental cleaning and spraying disinfectant in local areas is a must. • spreading awareness among people through online videos can be done. • overcrowding in the areas of essential places such as markets should be strictly avoided (world health organisation, c). since the covid- pandemic has forced to close educational institutions and industries, we have to depend on cloud based technologies to connect students with educational institutions and also artificial intelligence-enabled robots can prove to be helpful for many industries to work during these pandemic. without these advancements in technologies, this lockdown would be hard for individuals to cope up. individuals will feel exhausted at their home. presently, they are engaged with their movies on online streaming platforms. if there was isolation during the olden days, people would fig. technologies used during covid- ). these technologies helped mankind to invent new products like face masks (developed by d printing), ir thermometer (bio sensors) to provide safety for human beings and for the front line workers feel stressed without cell phones and media transmission. but nowadays, individuals are getting occupied with these innovations. technologies also played a vital role in data collection (artificial intelligence and big data), online classes (virtual reality) etc. some of the other technologies were also used to tackle this pandemic condition as shown in (fig. ). artificial intelligence has a feasible contribution in fighting against covid- as well as existing constraints. in terms of life and economic destruction, the risk of a pandemic is terrible. improving artificial intelligence and data analytics technologies have evolved continuously over the last decades. because of the lack of evidence, artificial intelligence has not been impactful against covid- yet. overcoming these constraints requires careful consideration of data privacy and public health issues as well as the interaction between human artificial intelligence. it will be necessary to gather diagnostic data from infectious people to save lives and reduce the economic havoc due to containment (mccall ). the goal of artificial intelligence is to deploy decision support using predictive analysis. artificial intelligence can help people by predicting the case of covid- which helps them to identify persons affected and take actions in a faster manner. patients with confirmed n-cov infection suffer from respiratory illness, fever, and cough. incubation time ranges from days to weeks (carlos et al. ) . supervised training is a practice and learning process. accordingly, the computers are equipped with sample data and then used for predicting new sampling of the results. the vast collection of health data from a wide range of outlets types include genome screening, electronic health records (ehr), and wearables contributed to biomedical big data (elavarasan and pugazhendhi ) . artificial intelligence was praised for its possible contribution to the development of new medicines. artificial intelligence helps in finding new drugs and a covid- vaccine. artificial intelligence creates an aid clinical preliminaries which are ought to perceive the ailment in patients, distinguish the quality targets and foresee the impact of the particle structured just as the on-and off-target impacts (mak and pichika ) data is used to run artificial intelligence models; it helps to handle the pandemic more efficiently. early warning is a much better way to cure the pandemic. a basic urine test is expected to assist clinical experts in recognizing future decompensation of covid- disease (early warnings ). the case of the artificial intelligence model based in canada, blue dot, has already become legendary. this shows that blue dot, a fairly low-cost artificial intelligence platform. it can predict infectious disease outbreaks in humans (predetermining artificial intelligence ). blue dot predicted the outbreak of the infection by the end of , according to accounts, where it identified the top destination cities where wuhan passengers will arrive. this warned that those cities may be at the forefront of the disease's global spread. patients with suspected -ncov were admitted and quarantined, and samples of the throat swab were obtained and the same data is sent to the -ncov chinese centre for disease control and prevention using a quantitative polymerase chain reaction test and the surveyed data was very much useful for the analysis of the covid- disease (chang et al. ) . artificial intelligence can be used to monitor and predict how covid- will spread over the period of time. for instance, a dynamic neural network was built to predict its spread following a previous pandemic, zika-virus of . algorithms were formulated to predict seasonal flu are now being retrained on new covid- data at carnegie mellon university. the atypical case of pneumonia, caused by a novel coronavirus ( -ncov), was first documented and confirmed on st december in wuhan, china ). fast and accurate covid- diagnosis will save lives, limit disease spread, and generate data on which to train models of artificial intelligence. artificial intelligence may provide valuable feedback in this regard, in particular with a diagnosis based on images (predetermining artificial intelligence ). according to a recent study by researchers working with un global pulse of artificial intelligence applications against covid- , studies have shown that artificial intelligence can be as reliable as human beings, can save the time of radiologists and diagnose faster and cheaper than regular covid- tests (predetermining artificial intelligence ). the field of biology and modern medicine is making more tremendous upgraded technology which is becoming data-intensive, by using these data and the field of deep learning technology is more helpful in treating the patients (ching et al. ). deep learning is useful when a problem arises with a patient of a particular disease, the data which is input to the computer represents the disease in the patient, the computer analyses many logical symptoms in the patient and the treatment is given according to the results of the computer (hinton ) . machine learning has proved effective in many analytical areas of risk. machine learning probably matters in three major areas, with clear medical risk (machine learning in healthcare ). • danger of infection what is the risk of having covid- for a specific person or group? • risk of severity what is the risk of extreme covid- symptoms or complications requiring hospitalization or intensive care of a specific patient or group? • result probability what is the probability of the ineffectiveness of a medication for a specific person or group? theoretically, learning by computer can aid in detecting all three risks. although it is still too early to get some covid- -specific machine learning research completed and written, early findings are very positive. we can also understand how machine learning can be used in related fields and how it can assist with covid- risk prediction (machine learning in healthcare ). early statistics indicate that important risk factors that decide the probability of a person contracting covid- include: sex, pre-existing illnesses, general grooming practices, social behaviour, amount of interaction between individuals, duration of interactions, place, and climate, socioeconomic status(machine learning in healthcare ) (see fig. ). machine learning has the potential to support clinicians' work processing and management of large amounts of medical data contained in electronic health records and used in clinical applications which includes recognizing high-risk patients in need of icu, the identification of early signs of lung cancer, determination of patient's respiratory status from x-rays in the chest, such deep learning approaches employ neural networks to predict the input-output data relationship. another potential feature of ml is its ability to reduce the cost of operation and product, automate, and enhance customer support (elavarasan and pugazhendhi ) . deep learning works more similar to machine learning where it can be separated into two types as "supervised applications-where the predicted goal is achieved accurately and unsupervised applications-where the goal is to summarize the data outcomes and identify the patterns of the outcome data" (hinton ) . deep neural network (fig. ) is learned and trained over a large set of data and they work on the multiple layers for the specified results and they are more accurate because they are learning from the previous outcomes of the data obtained (healthit analytics ; hinton ). machine learning and the rapid advancement of deep learning based technologies have demonstrated their ability to transform these big data in biomedical applications to a functional form. in general, ai and ml are introduced at the healthcare has increased patient safety, and successful treatment, and healthcare costs also has got reduced (elavarasan and pugazhendhi ) . when data on covid- is collected and analysed by a deep learning network it would save as many lives as possible and the computers would suggest the doctors for the treatment. deep learning helps in the classification of each and every task by the use of multiple layer strategy in the patients with the risk abnormalities found earlier with the same symptoms and by means of medical imaging (table ) (switching healthcare ). deep learning is a key technology where predictive healthcare systems can be developed, which can have access to a billions of data of the patients for the next generation (hinton ) . table provides a list of deep learning data and its uses in diverse medical fields and where data can be gathered and therapies provided to patients. there are several applications used for helping the government. some of the important apps used in india to control the pandemic condition is shown in (table ) and some of the top applications used in the world to tackle the covid- is shown in (fig. ) . these applications give clear monitoring status, feedback and also give guidelines to be followed by the people. it gives several updates about contact tracing which will be very much useful to the people. these applications utilise the telephone's bluetooth and gps capacities. it will track the affected persons by utilizing bluetooth. (hinton ) types of data application references electronic health records • it helps in indicating different population subtypes and to differentiate symptoms of gout and acute leukemia from uric acid lasko et al. ( ) • assigns the diagnosis process for the patients by previous clinical status liang et al. ( ) • to know about heart failure and chronic pulmonary illness in advance cheng et al. ( ) • advanced treatments over the onset of diseases by predicting from lab results razavian et al. ( ) • end-to-end method for forecasting after discharge unplanned readmission nguyen et al. ( ) clinical imaging • advanced imaging using magnetic resonance imaging (mri) scan to detect alzheimer's disease brosch and tam ( ) • it is used to meet the requirement of people during this pandemic gizbot ( ) these applications will also utilize a gps to track the record of an individual. these data will be updated on the mobile application if any person is tested with positive covid- . this will be done on the basis of an appraisal review of every individual. in such infected cases, the records will be transferred to the servers (tracking apps for covid- ). table provides the information about the list of applications and their functionality developed by the indian government to handle the pandemic condition. the internet of things (iot) could be a well-defined platform of interconnected computing strategies, computerized, and mechanical gadgets having the capability for transmission of information over the defined network without having any human inclusion at any level (singh et al. ). in addition, no research in the current literature attempts to analyze the position of emerging technologies like iot. it is a well-developed scheme of interconnected computing techniques, physical and mechanical devices with data communication capabilities over the specified one. network without any degree of human involvement (singh et al. ) . iot is a way beyond concept which develops a general architectural history, which allows for integration and fig. top applications used in the world to control the pandemic (covid watch ), (central and eastern europe legalblog ) , (immuni ) , (covid- smartphone applications ) fig. working of iot in health care domains which minimizes the contact between the affected individuals and the frontline workers effective exchange of data between needy persons and service providers. in the latest problematic pandemic scenario, the number of globally infected patients are growing day by day, and there are a large number of the sufficient and well-organized facilities provided with the methodology of iot. in addition iot already is also used for the purposes being demanded in various domains in healthcare (mohammed et al. ) (see fig. ). plasma is the fluid piece of blood that is gathered from patients who have recouped from the covid- . this disease is brought about by the infection named sars-cov- . covid- patients create antibodies in the blood against the infection. antibodies are proteins that may help to fight against the contamination (food and drug administration ). individuals who have completely recuperated from covid- in the last days are urged to consider giving plasma, which may help the lives of different patients. covid- based healing plasma should possibly be gathered from recuperated people in the event that they are qualified to give blood. people should have an earlier analysis of covid- recorded by a research centre test and meet other contributor models. people must have a total goal of manifestations for the past days before plasma donation. a negative lab test for dynamic covid- ailment is not required for plasma donation (food and drug administration ). there are many technologies that are used to reduce the effect of this pandemic, some of them are as follows, big data investigation helps in studying the infected individuals very effectively. these frameworks can control the development of the pandemic and also aids in observing individuals who are isolated. it also keeps an eye on individuals to check whether they are infected or they have been in contact with a contaminated individual. (management during pandemic ). self-driving vehicles, automated drones, and robots would be able to avoid human interaction. automated vehicles can be used to move impaired people to and from the medical service offices, without bargaining individual's lives. robots can be utilized in the circulation of food, warming, medical clinic sanitization, and road watching. these technologies help people who are facing many difficulties during these lockdown period (management during pandemic ). currently, digital learning is gaining its popularity and also it the trend which is heading forward in modern educational activities, models, and processes. this will be the big moment for the online learning and educational approaches that will be re-planned much like the businesses that are going to operate remotely (work from home) because of the covid- . the present scenario has pushed scholars and educational institutions towards online learning plans and technology (online education ). e-learning training is very useful in this pandemic situation because it is instantly accessible and it also offers flexible scheduling for the training (computer aided elearning team ). since virtual classrooms are important for student-faculty interaction, video conferencing platforms like google meeting and webex are getting used extensively by many educational institutions. also, software like proctorio, a google chrome extension that monitors whether students take their online exams regularly, which has helped the educational institutions to keep track of the students, who take up their online exams regularly. so, the learning has become digitized and this will help us to get rid of the use of paper and costly textbooks (online education ). these online classes offer a highly effective learning atmosphere for students so that they can learn from their respective locations (computer-aided e-learning team ). such initiatives and steps taken by the educational institutions are important because extended school closure and home isolation during a pandemic could have negative effects on the physical and mental health of children (wang et al. a, b, c) . with more than million web clients, india is the second biggest online market among all countries, positioned distinctly behind china. it was evaluated that by , there would be more than million web clients in the nation. regardless of the huge base of web clients, the web entrance rate in the nation remained at around % in . this statistics imply that around half of the . billion indians started using internet accessibility that year. there has been a steady increase in web accessibility but it is contrasted with only the past years, when the web entrance rate was around % (statistical usage ). though india is the second biggest online market among all countries, some children in rural areas are lagging behind, without the internet facility. this would rule out a large proportion of children from rural areas in internet usage (online education ). since the confirmed cases and deaths due to covid- are rapidly increasing day by day, both medical staff and the public have been undergoing psychological problems, like depression, stress, and anxiety. also, the transmission of viruses takes place at a faster rate between people. this obstructs face-to-face psychological interventions. therefore, internet services and telecommunication helped health care professionals to provide mental health support online during the covid- outbreak (liu et al. a, b) . since epidemic contagious diseases mostly interrupt the movement of people, transportation systems, and mobility of commodity, the use of drones in this situation will relieve humanitarian aid. the use of drones and quadcopters will generally help to do certain things like (i) evaluate and analyse the infected area by aerial monitoring (ii) epidemic cargo and logistic delivery (estrada ) (iii) aerial spray and disinfection (drone technologies ). unmanned aerial vehicles are used to monitor the people, who were unnecessarily roaming in the streets. those people can be warned and sent back through this facility. disease transmission can be controlled to a greater extent and it is cost-efficient. by travelling, a high quantity of fuel will be wasted and it is not practically possible to monitor all the areas. aerial monitoring systems will be helpful for the reduction of covid- transmission (benefits of drones ). drones were used in china and dubai to spray disinfectant chemicals in public places and on vehicles for disease prevention so that the transmission mechanism gets reduced. justin gong, co-founder of an agricultural drone company said that spraying disinfecting chemicals using drones has been more effective in comparison with hand spray (drone technologies ). the use of drones is a great boon for the workers and it reduces the risk of being infected by the pandemic in the infected areas. in india, these drones are effectively used to control the spread of the disease. if the people are seen outside doing mischievous activities they would be spotted and punished or warned. drones are very much useful to monitor a highly populated country like india. otherwise, the disease transmission rate would be even higher. the covid- outbreak has shown the pathway of hygiene for people all over the world. we must learn from mother nature to give equal rights to all living beings in the world and we must uphold it as a superior sense. it is our duty to protect nature for ourselves and for future generations. the pandemic has demonstrated the world's best new technologies that can hold children up to date with lectures, courses, and more online learning and educational exams that have contributed to a landscape of modern interfacing within months. the advanced ai and machine learning systems tend to operate the industries while the whole planet is being shut down due to the epidemic and the industrial goods are already being processed by these systems. the lockdown of cities has reinforced the relationship within a family by obtaining more freedom to communicate with each other, and it has been found that the use of traditional medicines has a great influence on the society. also during the quarantine period, people have learnt a great lesson from the epidemic of a novel coronavirus, the sophisticated technology supports the community with drones disinfecting the cities, interfacing robots, and gathering data from the infected communities without transmitting the virus to the physicians. the risk of being affected is high to the workers in the frontline, also people who travelled from other countries can be quarantined for the safety of their family, and the surroundings. the people who ever recognize the symptoms can admit themselves to test them for the disease, rather than being detected at the final stage of the illness. the human race had faced many outbreaks of many contagious diseases and had 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quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus ( -ncov) outbreak caution and clarity required in the use of chloroquine for covid- coronavirus cases daily new cases in china due to covid- world health organization (who) ( a) modes of transmission of virus causing covid- : implications for ipc precautions recommendations world health organization (who) ( b) coronavirus disease (covid- ) -events as they happen world health organization (who) ( c) prevention and control of covid- in prisons and other places of detention world health organization (who) ( d) draft landscape of covid- candidate vaccines a novel approach of consultation on novel coronavirus (covid ) related psychological and mental problems: structured letter therapy the fight against the -ncov outbreak: an arduous march has just begun preliminary estimation of the basic reproduction number of novel coronavirus ( -ncov) in china, from to : a data-driven analysis in the early phase of the outbreak clinical course and risk factors for mortality of adult inpatients with covid- in wuhan, china: a retrospective cohort study using deep learning for energy expenditure estimation with wearable sensors the authors thank dr.s.sivaramakrishnan ms ortho and dr. m. jayalalitha mbbs, shanthi ortho care hospital, tiruchirappalli, tamil nadu, india. they have helped us by suggesting some practical issues that are faced by the corona virus affected patients and the doctors working in the hospital during the covid- period. the inputs received has helped the authors in framing certain important sections of the paper. the authors declare that they have no conflict of interest. key: cord- - io g p authors: wang, yun-ping; zhou, xiao-nong title: the year , a milestone in breaking the vicious cycle of poverty and illness in china date: - - journal: infect dis poverty doi: . /s - - - sha: doc_id: cord_uid: io g p marking the end of the five-year programme initiated by the chinese government to lift more than million people out of poverty, the year is a milestone. poverty alleviation has moved strongly forward in china and the major health indicators are now better than the average of all middle- and high-income countries. however, the dual burden of infectious and chronic diseases remains a challenge with respect to achieving the health target in the united nations agenda for sustainable development goals (sdgs). in , about % of the poor population in china were impoverished by illness but already in , multi-sectoral actions delivered by the health-related poverty alleviation programme had reduced the number almost by half. in the past three years million poor people ( % of the poor population) with infectious and chronic diseases had been treated and taken care of thanks to financial support through multiple health insurance schemes and other governmental subsidies. this article discusses the lessons learnt with regard to health-related poverty alleviation in china with special reference to those still remaining impoverished by illness. consolidation of the achievements reached and provision of basic needs to those still disadvantaged and in poor health will require a major improvement of accessibility to, and affordability of, health services. the next step towards enhanced productivity and better living conditions will involve upgrading of the capacity of health professionals in the poor regions, promotion of coherent efforts in health-related poverty alleviation and rural revitalization measures. as an additional measure, data monitoring and research on health poverty alleviation should be strengthened as they are essential to generate the evidence and knowledge needed to support the move in the direction envisioned by the sdgs, and the new healthy china programme. ending poverty in all its forms everywhere is the first goal of the sustainable development goals (sdgs) of the united nations agenda [ ] . this goal, promising to leave no one behind [ ] , recognizes that ending poverty is the greatest of the global challenges ahead [ ] , since % of the world's population still live at or below usd . a day (the internationally agreed poverty line). although this figure is down from % in to % in in china [ ] [ ] [ ] , the goal is still far away. efforts to reduce poverty in association with poor health due to major communicable afflictions such as hiv/aids, tuberculosis, malaria, hepatitis and neglected tropical diseases (ntds), as well as maternal mortality, preventable deaths of newborns and children less than years old [ ] , were already part of the millennium development goals (mdgs), which have now been supplanted by the sdgs. indeed, poverty is the greatest adversary in relation to health in the developing countries and current evidence illustrates that good health is not only an outcome, but an essential component of poverty reduction [ ] . not that long ago, china had the world's biggest poor population, but has made spectacular progress in reducing health-related poverty [ ] and became already the first country to meet the mdg targets for reduction of the number of poor people by [ ] . over million people, amounting to % of the world's total poor, have been lifted above china's national poverty line since , the time when the country opened up and started economic reform [ ] . as of , china still had . million people in the rural areas living below the poverty line [ ] . this population was identified and selected as target for a programme referred to as the "decision of the central committee of communist party of china and the state council on winning the tough battle against poverty" [ ] . in , the president of china xi jinping pronounced that "a well-off society is for all people in china, no one should be left behindover next five years, china will lift all its current million living beneath the poverty line to safety, which is an important step in implementing development agenda after achieving china's two centenary goals for development" [ ] . with this he set in motion the fight against health-related poverty, one of the top priorities of the programme mentioned above. however, it is now clear that the two centenary goals cannot be reached in entirety without successful efforts to alleviate and eventually eradicate extreme poverty [ ] . according to the latest official data published by the chinese government, the rural poor population has been reduced by million in total, which corresponds to an annual average decline of around million people. meanwhile, the poverty incidence rate declined at an annual rate of . % (fig. ) receding from . % in to . % in . by the end of , an estimated % of the poor population around . million had been lifted out of poverty [ , ] . furthermore, the overall health status of the chinese people has now become better than the average of the middle-and highincome countries in the past years. for instance, from to , the average life expectancy increased from . to years, the infant mortality declined from . ‰ to . ‰, the under- mortality rate dropped from . ‰ to . ‰ and the maternal mortality rate fell from . to . per [ ] . three basic questions are up-front when looking at available evidence-based data from china: . what is the connection between poverty and illness? . how can the vicious cycle of poverty and illness be defeated? . which are the major lessons to be learnt from the health-related poverty alleviation programme? health affects national economic growth because people with disease or disability are likely to be less productive at work, lose their jobs, retire or die prematurely. naturally, all of these outcomes decrease household earnings and increase the risk of poverty. hence, the foregone reduction of national income due to illness is considerable in countries where poor health is common. for example, the projected cumulative global loss of economic output due to non-communicable diseases (ncds) from to is estimated at usd trillion, with the joint share of the low and middle income countries (lmics) amounting to around usd . trillion ( %) [ ] . in addition, the cost for treatment of major infectious diseases, such as those mentioned above and/or increased microbial resistance to therapeutic drugs incur a financial shortfall for affected individuals and households. out-of-pocket payments trap poor and near-poor households in a vicious cycle due to large personal expenditures leading to impoverishment and worse health, particularly in the lmics where social health insurance schemes are generally lacking. besides the ncds and major infectious diseases, the ntds constitute a group of diseases in tropical environments closely associated with poverty proliferation [ , ] . although many countries have made progress in the elimination of ntds, an estimated . billion people in still require treatment and care due to affliction with one or more ntds, among them about million ( %) in low-income countries [ ] , emphasizing the worldwide presence of poverty and inequality. every year, a reportedly million people globally are pushed into poverty, often due to illness and pre-existing sickness aggravated by lack of essential health services [ ] . as a large proportion of illnesses in the developing countries are entirely avoidable or treatable with existing medicines or interventions, disease burdens in these countries are often due to consequences of poverty, including poor nutrition, indoor air pollution and lack of access to proper sanitation and health education. historically, china has spent far too little on health, partly because health has not been seen as a "productive" part of the economy and also because of a previously low national income [ ] . one of the lessons learnt was the disastrous collapse of rural cooperative medical scheme (rcms), a community-based voluntary medical assistance scheme in the s, which led to more than million rural chinese losing health care coverage in the following two decades [ , ] . some of the rural households are impoverished and discontent due to increasing medical expenses and long-term health care costs that could not be afforded. alerted by several public focus events related to unaffordability of health expenditure, and the outbreak of the severe acute respiratory syndrome (sars) in , the chinese government launched the rural new cooperative medical scheme (ncms) for all the rural residents and rural medical financial assistance scheme (mfas) for the rural poor to cover their health expenditure that year, and implemented a new health care reform in , promising rmb billion (usd billion) over years to provide universal health coverage, strengthened health services delivery and drug supply for its population then amounting to . billion [ , ] . currently, more than % of the chinese population is covered by social health insurance schemes [ ] , and the percentage of people who needed, but did not receive, hospital-based treatment due to financial hardship decreased from . % in to . % in [ ] . this ignores those who seek treatment but fall into poverty as a result of expenditure. however, this kind of poverty-related lack of proper care is still a challenge in china and to eliminate infectious diseases among the poor and improve their accessibility and affordability with respect to disease prevention, treatment and rehabilitation services will take more time [ ] . for example, the results from three rounds of a national survey of important parasitic diseases showed that with the economic development, the average prevalence rate of soil-transmitted helminthiasis dropped from . % in to . % in , and continued down to . % in [ ] . another example is malaria, a disease with high mortality that traps households in poverty in many countries with a high burden of this infection [ ] [ ] [ ] , where chinese evidence shows a significant spearman's rank correlation coefficient correlations between poverty and incidence of malaria ( . , p < . ), as well as between poverty and epidemic hemorrhagic fever ( . , p < . ) for the years - [ , [ ] [ ] [ ] (fig. ) . among the poor in china, more than % are still impoverished by illness, such as cancer, childhood leukaemia, congenital heart disease, end-stage renal disease and infectious diseases, tuberculosis and parasitic diseases in particular [ ] . for the national poverty alleviation policy announced by the chinese government in , the key measures include: (i) establishing a long-term mechanism for poverty relief and wealth acquisition; (ii) strengthening of infrastructure and basic public services in poor regions; and (iii) support for development of local industries and economy. the programme, identified as a priority in the overall framework to roll back poverty, has a five-area focus: (i) improving access to essential health services covered by health insurance and financial assistance schemes; (ii) strengthening health infrastructure and service delivery capacities in poor and rural regions; (iii) providing educational and training opportunities including attractive recruitment and retaining policies for the health workforce; (iv) promoting infectious and endemic disease elimination; and (v) supporting maternal and child health and nutrition in poor regions. these activities proved effective in responding to health-related poverty and . million households have been lifted out of the trap of impoverishment due to illness [ ] . success in fighting health-related poverty can be attributed to a two-pronged approach: i) strong political commitment and substantial investment from the government at all levels; and ii) appropriate technical strategies for improving health care and public health for the poor [ ] . at the political level, the central government convened a national health conference in beijing in to promote "healthy china ", a new domestic, cross-sectoral, long-term strategy to support global health and health-related sdgs with the slogan "healthy lives and well-being for all" that was also used to continue the efforts combating emergence or re-emergence of infectious diseases. given the universal and multisectoral nature of health, there is an urgent need to elevate work towards health to a higher level of priority and importance in many national contexts. the "shanghai declaration on promotion of health in the agenda" reinforces good governance at all levels and is crucial for improving health-related matters [ , ] , which require investment and action at the local, national and also global levels. thus, health is perceived as a crucial entry-point to achieving the sdgs because of its ability to lift people out of poverty making it central for individual, household and national socioeconomic development. health is also is a critical component of human capital contributing to employability of people and general economic productivity. the government in china has explored ways to make health a multi-department priority and ensure crosssectoral cooperation through a range of mechanisms and institutions. the who adelaide statement produced a framework with health promotion as key policy components which has successfully reduced healthrelated poverty [ ] . in , the national health commission of china, together with other relevant ministries, issued guidelines for health poverty alleviation programme aimed to break the vicious cycle between poverty and illness by . in , six more concrete actions were proposed to achieve health-related poverty alleviation by . those actions included (i) improved medical care insurance for the targeted poverty-stricken population; (ii) provision of treatment and health management services covered by serious illness insurance for the poor with serious chronic diseases (which led to the expansion of the spectrum of serious chronic diseases from to diseases); (iii) implementing prevention and control of communicable and endemic diseases using an integrated strategy in poverty-stricken areas aimed at controlling hiv/aids, tuberculosis, echinococcosis, schistosomiasis, kaschin-beck disease (an endemic type of osteochondropathy) and keshan disease (cardiomyopathy caused by a combination of selenium deficiency and a mutated coxsackie virus); (iv) improving the delivery capacities in poverty-stricken regions at the county, township and village levels; (v) supporting maternal and child health and health promotion in poverty-stricken region; and (vi) strengthening support systems with priorities in policy making, project allocation, funding and social support to reduce poverty in the areas with most poverty (fig. ) . at the technical level, the principal approach was to find gaps related to limited or lack of qualified medical resources and to deliver sufficient and quality reliable health services to local populations. for example, by there were only . beds per population, and . certified medical doctors or assistants per population in the poverty-stricken counties in china, the numbers of which are much lower than that of the average numbers at national level [ , ] . secondly, precise health-related poverty alleviation approaches were performed at the county, family and individual levels with a focus on the most serious regions, targeted populations, and key diseases, aiming at integrating prevention with treatment by financial assistance through the poverty alleviation programme. thirdly, detail objectives were identified to ensure [ ] . (a spearman's rank correlation coefficient of poverty incidence and malaria incidence is . (p < . ). b spearman's rank correlation coefficient of poverty incidence and epidemic hemorrhagic fever incidence is . (p < . ). data source: poverty incidence data is from world bank database; and the incidence data of malaria & epidemic hemorrhagic fever is from china health statistics yearbook ) provision of primary health care to all povertystricken populations, and also to upgrade the capacity of the medical resources and services delivery to the national average level. fourthly, the three-pronged approaches were implemented by the following steps: (i) reviewing the epidemic trend and financial burden of the diseases among the poor population through a digital information platform; (ii) classifying the poor populations by disease, treatment service and financial protection needed; and (iii) identifying the most important diseases by population and geographical region by mapping for better targeting of medical care services and financial assistance (fig. ) . in addition, a three-years implementation plan on health-related poverty alleviation between and was implemented by the national health commission aiming to prioritize eradication of iodine deficiency, skeletal fluorosis and arsenic poisoning caused by coal burning and upgrade disease control with special reference to kaschin-beck and keshan disease, as well as eliminate schistosomiasis as public health problem and effectively control echinococcosis in western china. good progress on all these fronts has already been noted in the poverty-stricken areas. the successful lifting million people out of extreme poverty in the past four decades is mainly due to impressive economic growth and coherent policies that favoured improvements in incomes and livelihoods for the poorest of the poor [ , ] . the major activities of the successful poverty alleviation programme can be summarized as follows: (i) through investigation and registration of all poor households and individuals, several key diseases with clear diagnoses and treatment pathways adding financial burdens to the stricken households could be selected. up to major diseases were covered by the targeted assistance package, including childhood leukaemia, congenital heart disease, tumours, end-stage renal disease to mention a few. with respect to chronic diseases in poor patients, e.g., hypertension, diabetes, tuberculosis and severe mental disorders, family doctors were paid to offer systematic health management. (ii) by combining disease prevention with treatment along the approaches of the health poverty alleviation programme, both the capacity of health services delivery and financial protection could be improved. preventive and treatment services for hiv/aids, multi drug resistance tuberculosis, kaschin-beck disease, keshan disease and ntds including schistosomiasis and echinococcosis were among the diseases covered into the targeted disease treatment and subsidy package. the chinese government invested in standardized construction of county and township hospitals and village clinics, promoting tiered and integrated health services delivery, supporting hospital-to-hospital assistance between urban and rural areas and encouraging medical college graduates to work in the rural and remote areas in central and western china. in addition, all registered poor people now enjoy a three-tiered financial protection, namely basic health insurance, major disease insurance and medical financial assistance schemes. to support the poor population, out-ofpocket payments were capped at % of their health expenditure. for some extremely poor households, out-ofpocket health expenditure was completely covered. (iii) in order to support the development of better health care in the poverty-stricken regions, the chinese government established a strict top-town performance evaluation and accountability mechanism with indicators of poverty alleviation and multi-sectoral cooperation to mobilize various social resources for more precise measures. many provinces have adopted a mechanism of "one strike and you're out". under this system, a local government's failure to hit poverty alleviation targets cancels out successes against all other performance targets on which it is assessed. besides fiscal investment, the government also made important progress in a number of areas identified by researchers as an essential component of poor people's endogenous development capacities. this includes early childhood development and nutrition, universal health coverage, universal access to quality education and cash transfers to poor families, rural infrastructure, especially roads and electrification and progressive taxation. private sector and non-governmental organizations, and the communities have also been engaged in the poverty alleviation programme. health-related poverty alleviation relies strongly on improving food and nutrition, housing, education, employment and other basic living conditions, which have therefore been incorporated into the systematic, national strategies of the different programmes health-related poverty alleviation, rural revitalization and healthy china . the former programme also promotes other parallel actions tackling key obstacles related to poverty reduction, while the rural revitalization strategy aims to facilitate rural socioeconomic, ecological and cultural development in the post-poverty alleviation period to further consolidate achievements and improve the well-being of the rural population, while the healthy china programme acts by improving health infrastructure construction and services delivery in poor counties, thereby providing basic public health services, rehabilitation services and financial protection for the poor. the implementation of overarching national strategies in a holistic approach with long-term perspective can theoretically cancel out the impact of negative socioeconomic determinants of health and health-related poverty. however, although the programme on health-related poverty alleviation has already made a great positive impact on socioeconomic development in poor regions, resources such as hospitals beds, doctors and auxiliary staff are still seriously lacking in poor counties which have not been able to deliver sufficient qualitatively reliable services to the population making it difficult to achieve the sdgs health targets in the short term [ ] . therefore, medical services and health insurance and other financial protection systems need to be better aligned. according to the world bank, the key challenges ahead for china include further improved access of health services for those needing them as well as better data monitoring on poverty and health since those still remaining in poverty, such as the elderly and ethnic minorities, demand even stronger efforts than used so far. in order to strengthen the health status for all, leaving no one behind and thus achieve the goal of improving the situation for all currently living below the poverty line, the following three actions are recommended: (i) strengthening multi-sectional cooperation and investment coordination during the implementation of health-related poverty alleviation anchored in improving the health services delivery capacities of the rural health facilities, the financial protection capacity to lift out the rural poor with follow-up measures to prevent diseases, maintain health and enhance the productivity abilities; (ii) more intensive and robust research conducive to evidence-based information and its dissemination to decision makers, including research on health systems strengthening in the poor regions, cost-effectiveness analysis and social ethics analysis of priority settings for the decision making in health-related poverty alleviation, and (iii) more actively engagement in global health cooperation and development, such as knowledge sharing and capacity building, to learn from global societies in tackling with the extreme poor with serious illness and incapable to work in the long-run, as well as in generating the experience and lessons from china for other developing countries fighting against health-related poverty. the year marks the end of the major, five-year programme on poverty alleviation initiated by the chinese government. huge progress has already been achieved and the results should now be consolidated to promote further advancement towards the sdgs targets. the challenge in the post-poverty alleviation period is to reach the healthy china goal of realizing a world without poverty and endemic diseases. this asks for total elimination of healthrelated poverty and requires china to provide more assistance to its extremely poor, many of whom struck with serious illnesses, having lost production resources and being in need of long-term health care. transforming our world: the agenda for sustainable development (a/res/ / ) world health organization. health in the post- development agenda. sixty-sixth world health assembly (a / ). geneva: who measuring the health-related sustainable development goals in countries: a baseline analysis from the global burden of disease study neglected tropical diseases in the sustainable development goals who's been left behind? why sustainable development goals fail the arab world the association between living below the relative poverty line and the prevalence of chronic obstructive pulmonary disease poverty biggest enemy of health in developing world, secretary-general tells world health assemblyhttps whatever happened to china's neglected tropical diseases? neglected tropical diseases in the people's republic of china: progress towards elimination china's reform and opening-up creates miracle in poverty reduction the central committee of communist party of china and the state council. decision on winning the tough battle against poverty a systematic analysis with implications for the sustainable development goals outstanding achievements for poverty alleviation to continuously improve the people's life in beijing: china union medical college press; . who and unicef. health in the post- agenda asymmetries of poverty: why global burden of disease valuations underestimate the burden of neglected tropical diseases social sciences research on infectious diseases of poverty: too little and too late? global report for research on infectious diseases of poverty. geneva: world health organization impact of an innovative tuberculosis financing and payment model on health service utilization by tuberculosis patients in china: do the poor fare better than the rich? evaluations and suggestions on health system reform in china realignment of incentives for health-care providers in china launch of the health-care reform plan in china achievements in deepening the health care reform in the th anniversary of the founding of new china analysis report of the fifth national health services survey in china. beijing: china union medical university press current situation and progress toward the health-related sustainable development goals in china: a systematic analysis greater political commitment needed to eliminate malaria is malaria a disease of poverty? a review of the literature poverty and malaria in the yunnan province spatiotemporal analysis and forecasting model of hemorrhagic fever with renal syndrome in mainland china shrinking the malaria map in china: measuring the progress of the national malaria elimination programme mobile population dynamics and malaria vulnerability: a modelling study in the china-myanmar border region of yunnan province, china research report on the development of healthy poverty alleviation in china disease control priorities: improving health and reducing poverty shanghai declaration on promoting health in the agenda for sustainable development adelaide statement on health in all policies: moving towards a shared governance for health and well-being, report from the international meeting on health in all policies ministry of finance, national healthcare security administration, the state council leading group office of poverty alleviation and development. implementation plan of three-year key action of health-related poverty alleviation we thank anonymous reviewers for providing comments to improve the manuscript.authors' contributions xnz and ypw collected the data, identified the species and wrote the first draft; and xnz guided the english writing and revised the first draft. all authors read and approved the final manuscript. ethics approval and consent to participate not applicable. competing interests xnz is the editor-in-chief of the infectious diseases of poverty. key: cord- -n v y authors: atreja, ashish; gordon, steven m.; pollock, daniel a.; olmsted, russell n.; brennan, patrick j. title: opportunities and challenges in utilizing electronic health records for infection surveillance, prevention, and control date: - - journal: am j infect control doi: . /j.ajic. . . sha: doc_id: cord_uid: n v y nan opportunities and challenges in utilizing electronic health records for infection surveillance, prevention, and control there are unique patient safety challenges in the prevention and control of health care-associated infections (hai). it is estimated that approximately million hai occur every year in the united states, and each infection increases the risk of death by as much as times. this amounts to an estimated , deaths annually and $ . billion excess health care costs. , the emergence of specific multidrug-resistant organisms (mdro), the growing number of immunocompromised patients, and the increasing number of invasive procedures and medical device implantations are posing new challenges for infection control. how many of these hai are preventable remains unclear, but payers such as the centers for medicare medicare & medicaid services have already enacted rules that preclude reimbursement for certain conditions that are attributed to hospitalization, eg, catheter-associated urinary tract infections. initiatives such as the institute for healthcare improvement's , and millions lives campaigns, the joint commission's national patient safety goals, and guidelines for public reporting of hai reflect growing concern over hai and the need for their prevention. , many such initiatives are evidence based and have shown to reduce the rate of hai. for example, adherence to the ''bundle'' (hand hygiene, full-barrier precautions during insertion of catheter, using chlorhexidine antiseptic to clean the skin, avoiding the femoral site, and removing unnecessary catheters) was recently shown to reduce significantly the rates of catheter-related bloodstream infections among patients receiving care in intensive care units. however, creating a successful culture of safety requires a significant investment in both education of health care personnel and infrastructure support. currently, a third of all hospitals have less than recommended ratio of infection control professionals (icps) to patient beds (a ratio of . to . icp for every occupied acute care beds). hence, icps struggle to keep up with essential infection control tasks because of other competing responsibilities and lack of adequate resources. without deploying resources that allow for automation, it may not be possible for icps to collect more and richer data (such as catheter-days and details on adherence to the bundle for catheter insertion) and at the same time design specific interventions required for pay-for-performance initiatives. emerging information technology such as electronic health records (ehrs) can help meet these challenges. they can facilitate automated collection of surveillance data, provide risk-adjusted patient outcomes, and facilitate infection control interventions at the point of care. in , the us department of health and human services declared the start of a ''decade of health information technology (health it)'' (appendix) and called for universal ehr adoption by . the increased adoption of ehrs and related health it provide a unique opportunity for icps and infection diseases specialists to automate manual processes and address the growing challenge of hai and guidelines for public reporting. the present paper is an awareness and advocacy paper from the healthcare infection control practices advisory committee (hicpac), which provides advice to the department of health and human services and the cdc regarding surveillance, prevention, and control of hai and related occurrences (http:// www.cdc.gov/ncidod/dhqp/hicpac_charter.html). the paper should not be construed as a standard of care or guideline but as a viewpoint document that aims to ( ) provide a conceptual overview of opportunities in utilizing ehrs for infectious disease management, in its most simple form, ehr can be defined as computerization of health record content and associated processes. the term ehr has often been used interchangeably with emr (electronic medical records) even though there are minor but significant differences between the terms. emr is the older term in use and is often associated with electronic patient record systems within an institution. ehr is usually considered the term most reflective of the actual patient experience of receiving health care across institutions. we chose to use the term ehr instead of emr to reflect the growing consensus toward a need for interoperable electronic records. as part of a national effort to encourage the adoption of ehrs, an institute of medicine panel has identified a set of core functions that ehrs should perform to promote greater safety, quality, and efficiency in health care delivery (fig ) . , health information and data, results management, electronic communication, and administrative processes are either built-in or readily supported by the majority of the existing ehrs. health information and data and results management allow for an efficient view of patients' past records including medications, allergies, past admissions, and laboratory and microbiology results. electronic communication enables better coordination of care plan among multiple providers and ancillary services as well as timely notification of critical patient data. administrative processes such as scheduling and billing increase the efficiency of heath care organizations, provide timely service to patients, and decrease the paperwork. order management, clinical decision support, patient support, and population health functions have the potential for a more direct impact on infectious disease management, surveillance, prevention, and control but are not generally essential components of all present day ehrs. order management includes functions such as computerized physician order entry (cpoe), which allows electronic entry of laboratory, medications, and radiology orders instead of orders being recorded on paper sheets or prescription pads. the electronic entry allows clinical decision support (cds) functions to compare the order against standards for dosing, allergies, and others and warn the physician about potential problems. patient support means providing tools such as patient portals or personalized health records (phrs), which give patients access to their health records, provide patient education, and help patients carry out home monitoring and self-testing. this can empower patients and help improve control of chronic conditions, such as diabetes and congestive heart failure. reporting and population health management support the use of already collected electronic data in ehr for uses other than clinical care. quality management, outcomes reporting, and infectious disease surveillance are included in this category. although the benefits of health information, result management, electronic connectivity, and administrative support activities in terms of / chart access and better availability of the data are apparent and well understood, cpoe and cds when customized and utilized appropriately can also have a direct and significant impact on patient care. cpoe can support process improvement, increase accuracy and legibility of the order, and integrate cds into the order-entry process. , cds can provide alerts for drug-drug, drug-allergy, and drug-food interactions based on routinely updated drug formularies. in addition, cds also includes reminders, prompts, and alerts to improve compliance with best clinical practices and hyperlinks that can provide context-specific drug or disease information to the provider at the point of care. studies have shown that properly designed cpoe and cds can lead to as much as % reduction in serious medication errors. other system-wide benefits from fully functional ehrs include increased compliance with preventive care guidelines, better coordination and management of chronic conditions, improvement in quality indicators for pay-for-performance initiatives, reduced staff time spent on paperwork, reduced number of duplicate or unnecessary laboratory and imaging orders, and increased accuracy and timeliness of billing. to support infectious disease (id) management, cds can be customized to incorporate patient-specific clinical information such as laboratory or microbiology information along with diagnostic, demographic, and clinical guidelines. this allows for several modes of decision support including alerts for critical laboratory values and recommendations for best antibiotic practices. figure shows a cds where information from patient and a knowledge base feed into an inference engine (a software that uses different rules to draw conclusions) to generate a computerized alert that specifies the need for isolation and a negative-air room for a patient that is suspected to be infected with mycobacterium tuberculosis. cds can also be customized to generate reminders to enhance vaccination rates and preventive screening that have shown to be more effective and less expensive than the paper-based reminders. , it is estimated that such computerized reminders to providers at the point of care can lead to a . % to . % increase in preventive health activities such as pneumococcal and influenza vaccinations. cds can also help address the persistent problem of inappropriate antimicrobial prescribing that can promote antimicrobial resistance. for example, evans et al reported the use of an antiinfective-management program that recommended antimicrobials for patients admitted in intensive care unit and provided warnings and immediate feedback. the use of the program led to significant reductions in orders for antibiotic-susceptibility mismatches ( vs , respectively, p , . ) and in adverse events caused by antiinfective agents ( vs , respectively, p , . ). in addition, patients who always received the regimens recommended by the computer program had reduced length of the stay (adjusted mean, . vs . days, respectively; p , . ) and total hospital costs (adjusted mean, $ , vs $ , , respectively; p , . ). in a separate study, the authors reported that the percentage of patients having surgery who received appropriately timed preoperative antimicrobial prophylaxis increased from % to . %, and the antibiotic-associated adverse drug events decreased by %. during the study, antimicrobial resistance patterns were stable, and mortality rates decreased from . % in to . % in (p , . ). the authors concluded that computer-assisted decision support programs can improve antibiotic use, reduce associated costs, and stabilize the emergence of mdro. in summary, cpoe and cds can decrease medication errors by increasing accuracy and legibility of the physician orders and providing alerts for drugdrug, drug-allergy, and drug-food interactions. in addition, they can help reduce inappropriate antimicrobial prescribing, which is one of the leading causes of adverse drug events and antimicrobial resistance. these tools can be also customized specifically to improve isolation practices for those infected with mdro or active contagious diseases. surveillance is defined as a comprehensive method of measuring outcomes and related processes of care, analyzing the data, and providing information to members of the health care team to assist in improving those outcomes. , manual methods to identify potential hai cases by chart reviews, entering data, and looking for associations can be inefficient, labor intensive, and error prone. ehrs can automate many of these processes. if properly designed, ehrs and related health it can also help in data analysis by identifying abnormal distributions of variables from large interrelated databases. this has shown to be more efficient (requiring one third to one sixth the amount of time required by standard surveillance methods) and effective in screening potential outbreaks as well as finding and reporting endemic hai. , with current emphasis on mandatory reporting of hai and requirement by some states to perform house-wide surveillance, ehrs and related information technologies provide a unique opportunity to support the paradigm shift to automated surveillance strategies, which allow icps to minimize time spent finding hai and to maximize time spent preventing them (fig ) . ehr-supported surveillance has the potential for being a more proactive approach compared with traditional techniques for case finding by which data are collected post hoc after the infection or outbreak has happened. for example, pittet et al used their hospital information system to generate a ''readmission alert'' to icps that informed them about a readmission to the hospital of any patient previously colonized or infected with mrsa. during the first months of application, delayed recognition of readmitted mrsa carriers decreased significantly, and the proportion of mrsa patients recognized at the time of admission to the hospital increased from % to % (p , . ). the effectiveness of this approach has also been reported by gransden et al, who found that two thirds of patients readmitted to the hospital were not known to be previously infected by the admitting staff and were instead alerted by the computerized system. early identification of patients at risk, such as at the time of hospital admission, allows icps to conduct active surveillance and take prompt contact precautions if needed to prevent nosocomial spread. this strategy has been found to be cost-effective and supported by institutions that do not have comprehensive ehrs can benefit from utilizing web-based systems and other health information technologies for hai prevention, control, and surveillance. for example, the chicago antimicrobial resistance project (carp) reported a successful use of the clinical data warehouse to automate measurement of performance indicators and surveillance for infection control. the clinical data warehouse was designed to store data collected from both nonelectronic sources (eg, manually abstracted data from patient medical records and scanned surveys) and electronic data from many different hospital information systems: pharmacy, laboratory, radiology, medical records, and emergency department. the carp data warehouse has been used in regular surveillance activities such as determining rates of hai, central venous catheter use, and antimicrobial resistance as well as for quality improvement activities. these investigations as well as others highlight potential applications that utilize increased convergence between ehrs and laboratory and pharmacy information systems for electronic reporting of endemic and syndromic conditions in the population. , a recent report described a stand-alone electronic anesthesia record system and sigma methodology to improve successfully the timing of perioperative antibiotic prophylaxis before surgical incision. the time interval for antibiotic administration before surgical incision decreased from a preintervention mean of minutes ( % ci: - minutes) to minutes ( % ci: - minutes) (p , . ). a recently published study reported using an intranet-based tool for improvement and documentation of influenza vaccination and declination rates of , health care personnel in an -bed hospital. with an estimated direct cost of $ , the intranet-based tool was associated with a significant increase in documented vaccination rates from % to % in year. there are commercial surveillance technology software that can work with ehrs or other health information systems to help automate identification of hai using algorithms that analyze laboratory results, admission records, and possible pathogens. the majority of these can be readily implemented within a few months. some of these products can simultaneously track infection data and combine it with pharmacy data such as antibiotic use to generate antibiotic utilization and resistance reports and recommend targeted and cost-effective antibiotic selections at the point of care. a few can even provide real-time infection risk profiles via an electronic clinical dashboard that helps alert clinicians to specific patients who may be at high risk for infection. , in addition, some may facilitate efficient and timely reporting of notifiable conditions to public health agencies. more detail on commercial surveillance technology solutions is reported elsewhere (www.manageinfection.com/ - /mic w . pdf). because these solutions may require significant capital investment and customization, a thorough analysis is recommended to find the best fit for an organization. there are also cdc-led initiatives for endemic hai and outbreak surveillance. for example, the national healthcare safety network (nhsn) is a web-enabled surveillance system designed for surveillance of hai in health care facilities. , enrollment in the nhsn is free and currently open for hospitals and outpatient hemodialysis centers. the nhsn allows entry of event and denominator data for both device-and procedureassociated events as well as data entry for microbiology susceptibility and antimicrobial use that can be risk adjusted and used for interfacility comparisons and quality improvement activities (fig ) . in addition, the nhsn plans to implement modules that will focus on mdros, central line insertion practices, and high-risk patient influenza vaccination. there are an increasing number of states that are adopting nhsn participation as a platform for responding to legislative mandates for public reporting. during the global epidemic of severe acute respiratory syndrome (sars), the cdc successfully utilized web-based tools to rapidly establish multiregion syndromic surveillance. a total of emergency departments reported syndrome frequencies from more than , patient encounters, confirming the usefulness of web-based systems for triage and outbreak surveillance. currently, the cdc's biosense application is aimed at detecting early signs of disease outbreaks by gathering real-time data related to illness syndromes and clinical severity and confirmed clinical findings from hospitals to cdc. the application provides electronic ''views,'' analytics, and reports to inform outbreak surveillance at national, state, and local public health levels and aims to reduce burden of clinical data collection during the early outbreak investigation. because each health care organization must tailor its surveillance according to its population characteristics and outcome priorities, it helps to list clearly the purpose and objectives of the surveillance system and indicate its level of usefulness to the organization. the cdc has published guidelines for evaluating public health surveillance systems that can also be applied to commercial surveillance software and information systems at individual health care facilities. after determining the objectives of the surveillance systems, evaluation should assess system attributes, including simplicity, flexibility, data quality, acceptability, sensitivity, predictive value positive, representativeness, timeliness, and stability. it is also useful to assess whether the system uses data exchange and messaging standards that can automate data collection from ehrs and existing health it and facilitate reporting to public agencies. although automation enhances efficiency, it does not by itself lead to more accurate data. overt reliance on administrative or billing databases can lead to inaccurate and misleading reporting. , hence, due diligence should be exercised to confirm the accuracy of data and associated processes so as to meet the requirements of an epidemiologically sound surveillance system. , transformation in current practice of id management, surveillance, prevention, and control will not occur without proactive involvement of id specialists and icps in health it initiatives at the local, regional, or national level. awareness about health itand its adoption and advocacy is key to successfully leveraging ehrs and related information technologies. the icps and id specialists need to first become aware of the changing landscape in the field of infection control; the opportunities created by modern health it to realize the new paradigm; and the evolving role of health it in surveillance, prevention, and control of hai. it is necessary to become familiar with current and planned it initiatives in ones own health care institution and at regional, state, and national levels to promote synergy and prevent duplication of efforts. regular communication and dialogue with health care institutions' chief informatics officer or chief technology officer could be the initial step in starting to know more about an institution's short-and longterm health it strategies. at present, only in physicians use some type of ehrs, and fewer than in use a comprehensive ehr system. the return on investment and incremental benefit of ehrs increase when they can also be utilized for id management, surveillance, prevention, and control. because ehrs differ with respect to their features, it is important for icps and id specialists to know which ehr has functionalities that can support their practices (see table ). icps in institutions that have already adopted ehrs or made the decision to do so should, as subject experts, help with the customization of the ehrs to support best practices for id management and surveillance. there needs to be advocacy to decision makers at the federal, state, and local levels for the promotion of a synergistic strategy to leverage it for id management and surveillance. currently, many of the ehrs are not prepackaged with decision support capabilities and the surveillance solutions required for id management and control. this requires many institutions to either customize the ehrs or resort to stand-alone commercial surveillance systems to meet their requirements. hicpac plans to work closely with standard developing organizations such as health level (hl ) to drive standards and support for features and functions that enable id management and surveillance. it is important to realize that ehr is not a panacea but an important and critical tool in patient-centered health care. there are many significant barriers to widespread use of ehrs that could limit its potential to transform our practices in the st century. most notable are the cost of technology, the lack of standards to support data exchange, and the potential for adverse consequences if not implemented correctly. cost is the cited as the biggest impediment to the widespread implementation of health it. it has been estimated that universal ehr adoption and interoperability will cost $ billion in capital investment over years and $ billion in annual operating costs. in addition, there needs to be continued investment in human capital that has a diverse skill set (programming, database administration, network support, project management, data mining, statistics, clinical informatics, and others) if full benefits of ehr are to be realized. another impediment to widespread health it adoption is the lack of standards that allow for nationwide interoperability. hence, the fact that a patient has had mrsa in one institution can be completely missed by another institution even if both institutions have ehrs. furthermore, many ehrs lack functions that support cds customization or allow for reporting, population health, or surveillance. in , the certification commission for healthcare information technology (cchit) was formed to create certification criteria for health care it products, including ehrs (www.cchit.org). cchit provides a list of ehrs that are certified to have these functions so that end users can expect to leverage them for their clinical, research, and surveillance needs. there is also growing concern that technology, if not properly utilized, can lead to unintended consequences such as more/new work for clinicians, untoward changes in communication patterns, generation of new kinds of errors, and overdependence on the technology. any new implementation of health it needs to be rigorously tested and regularly evaluated to prevent such unintended consequences of technology. each health care infection control program is distinctive, but the expectation is that each is based on sound epidemiologic principles and meets the standards required to address the growing problem of hai. it is essential that informatics principles be widely understood if icps are to develop the capacity to manage and utilize information systems to address hai and other adverse events associated with the delivery of health care. ehr-based automated surveillance, reporting, and hai epidemiology can allow icps to focus their efforts toward education and interventions rather than manual data gathering. at the same time, ehrs can promote better antimicrobial prescribing, enhance immunization practices, and help in prompt identification and isolation of patients with mdro. id specialists and icps need to become aware of emerging technologies and get involved in advocacy and adoption efforts at local, regional, and national levels to leverage the opportunities created by current health it initiatives. glossary biosense: biosense is the cdc national initiative designed to improve the nation's capabilities for realtime biosurveillance and situational awareness. by providing access to data from hospitals and health care systems in major metropolitan cities across the nation, biosense is connecting existing health information to public health in a way not previously possible (http:// www.cdc.gov/biosense). cdr, clinical data repository: cdr is a database that consolidates data from a variety of information sources to present a unified view for a clinician or researcher. typical data types that are often found within a cdr include the following: laboratory test results, patient demographics, pharmacy information, radiology reports and images, pathology reports, hospital admission/discharge/transfer dates, icd- codes, discharge summaries, and progress notes. cpoe, computerized provider order entry: a computer application that allows a physician's orders for diagnostic and treatment services (such as medications, laboratory, and other tests) to be entered electronically instead of being recorded on order sheets or prescription pads. cds, clinical decision support: computer tools or applications to assist physicians in clinical decisions by providing evidence-based knowledge in the context of patient-specific data. examples include drug interaction alerts at the time medication is prescribed and reminders for specific guideline-based interventions during the care of patients with chronic diseases. erx, electronic prescribing: a type of computer technology whereby physicians use handheld or personal computer devices to review drug and formulary coverage and to transmit prescriptions to a printer or to a local pharmacy. e-prescribing software can be integrated into existing clinical information systems to allow access to patient-specific information to screen for drug interactions and allergies. health it, health information technology: the application of information processing involving both computer hardware and software that deals with the storage; retrieval; sharing; and use of health care information, data, and knowledge for communication and decision making. a central element of health it is the patient's electronic health record. hl , health level seven: a standard setting organization for health it specifically in clinical and administrative data (www.hl .org). interoperability: the ability of a system or a product to work with other systems or products without special effort on the part of the customer. nhin, national health information network: describes the technologies, standards, laws, policies, programs, and practices that enable health information to be shared among health decision makers, including consumers and patients, to promote improvements in health and health care (http://www.hhs.gov/healthit/ healthnetwork/background). nhii, national health information infrastructure: often used synonymously with nhin. nhii came before nhin and is an acronym that encompasses all of the necessary components needed to make ehrs interoperable. nhin, as the name suggests, refers to both the physical and national network needed for interoperability to occur. nhsn, national healthcare safety network: a webenabled surveillance system designed for use by the cdc and its health care partners for the purpose of improving patient and health care worker safety. nhsn merges predecessor surveillance systems maintained by the division of healthcare quality promotion (dhqp) in the cdc's national center for prevention, detection, and control of infectious diseases (ncpdcid). these were the national nosocomial infections surveillance (nnis) system, the national surveillance system for healthcare workers (nash), and the dialysis surveillance network (dsn). onchit, office of the national coordinator for health information technology: provides leadership for the development and nationwide implementation of an interoperable health information technology infrastructure to improve the quality and efficiency of health care and the ability of consumers to manage their care and safety. the national coordinator for health information technology serves as the health and human services secretary's principal advisor on the development, application, and use of health information technology (www.hhs.gov/healthit). phr, personal health record: an electronic application through which individuals can maintain and s vol. no. supplement manage their health information (and that of others for whom they are authorized) in a private, secure, and confidential environment. rhio, regional health information organization: a multistakeholder organization that enables the exchange and use of health information, in a secure manner, for the purpose of promoting the improvement of health quality, safety, and efficiency. officials from the us department of health and human services (hhs) see rhios as the building blocks for the national health information network (nhin). when complete, the nhin will provide universal access to electronic health records. estimating health care-associated infections and deaths in us hospitals nosocomial infection update guidance on public reporting of healthcare-associated infections: recommendations of the healthcare infection control practices advisory committee medicare plans to stop paying for hospital-acquired conditions. am-news staff an intervention to decrease catheter-related bloodstream infections in the icu staffing requirements for infection control programs in us health care facilities: delphi project key capabilities of an electronic health record system: letter report using technology to promote gastrointestinal outcomes research: a case for electronic health records computer physician order entry: benefits, costs, and issues the impact of computerized physician order entry on medication error prevention effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review improving preventive care by prompting physicians a computer-assisted management program for antibiotics and other antiinfective agents implementing antibiotic practice guidelines through computer-assisted decision support: clinical and financial outcomes updated guidelines for evaluating public health surveillance systems: recommendations from the guidelines working group recommended practices for surveillance: association for professionals in infection control and epidemiology (apic), inc statewide system of electronic notifiable disease reporting from clinical laboratories: comparing automated reporting with conventional methods harris ad. preliminary assessment of an automated surveillance system for infection control an evaluation of surveillance methods for detecting infections in hospital inpatients infection rate reporting and the ehr miles apart: a puzzle wrapped up in a riddle. healthcare purchasing news automatic alerts for methicillin resistant staphylococcus aureus surveillance and control: role of a hospital information system computerized detection of re-admission of patients with mrsa screening high-risk patients for methicillin-resistant staphylococcus aureus on admission to the hospital: is it cost-effective? shea guideline for preventing nosocomial transmission of multidrug-resistant strains of staphylococcus aureus and enterococcus development of a clinical data warehouse for hospital infection control hospital electronic medical record-based public health surveillance system deployed during the winter olympic games improving infection control, prevention, and surveillance: using the electronic health record (ehr) in a -bed acute care hospital six sigma methodology can be used to improve adherence for antibiotic prophylaxis in patients undergoing noncardiac surgery novel use of the intranet to document health care personnel participation in a mandatory influenza vaccination reporting program a review of strategies for enhancing the completeness of notifiable disease reporting the changing face of surveillance for health care-associated infections national healthcare safety network (nhsn) report, data summary for sars surveillance project-internet-enabled multiregion surveillance for rapidly emerging disease biosense: implementation of a national early event detection and situational awareness system administrative data fail to accurately identify cases of healthcareassociated infection comparisons of health care-associated infections identification using two mechanisms for public reporting electronic laboratory reporting for the infectious diseases physician and clinical microbiologist the costs of a national health information network types of unintended consequences related to computerized provider order entry key: cord- -w aoogjj authors: labrague, leodoro j.; de los santos, janet title: fear of covid‐ , psychological distress, work satisfaction and turnover intention among frontline nurses date: - - journal: j nurs manag doi: . /jonm. sha: doc_id: cord_uid: w aoogjj aim: to examine the relative influence of fear of covid‐ on nurses’ psychological distress, work satisfaction and intent to leave their organisation and the profession. background: the emergence of covid‐ has significantly impacted the psychological and mental well‐being of frontline healthcare workers, including nurses. to date, no studies have been conducted examining how this fear of covid‐ contributes to health, well‐being and work outcomes in frontline nurses. methods: this is a cross‐sectional research design involving frontline nurses in the philippines. five standardised scales were used for data collection. results: overall, the composite score of the fear of covid‐ scale was . . job role and attendance of covid‐ ‐related training predicted fear of covid‐ . an increased level of fear of covid‐ was associated with decreased job satisfaction, increased psychological distress, and increased organisational and professional turnover intentions. conclusions: frontline nurses who reported not having attended covid‐ ‐related training and those who held part‐time job roles reported increased fears of covid‐ . addressing the fear of covid‐ may result in improved job outcomes in frontline nurses, such as increased job satisfaction, decreased stress levels and lower intent to leave the organisation and the profession. implications for nursing management: organisational measures are vital to support the mental health of nurses and address their fear of covid‐ through peer and social support, psychological and mental support services (e.g., counselling or psychotherapy), provision of training related to covid‐ , and accurate and regular information updates. covid- is a disease important in public health globally. this pneumonia-like disease emerged in wuhan, china in november , which the world health organization later called coronavirus disease or covid- (who, ) . within a few months, covid- has caused significant damage to public health, while causing financial and economic loss in many countries. globally, confirmed cases of the disease had reached , with confirmed deaths. as of august , , cases of covid- had been reported in more than countries on six regions. the us remains the country with the highest number of confirmed cases and fatalities, followed by brazil, india, and russia, which account for % of all confirmed cases globally (who, ) . in the philippines, confirmed cases of covid- have reached , with confirmed deaths (department of health, a) . among asean countries, the country ranked st in terms of number of confirmed cases and deaths. this was despite extensive measures to prevent the transmission of the disease, such as strict social distancing, community quarantines and education campaigns about the disease. since the earliest days of the nursing profession, nurses all over the world have played a significant role during disaster and emergency situations, including disease outbreaks. nursing organisations such as the international council of nurses (icn) emphasised the critical role that nurses play during emergency and disaster situations. while nurses remain committed to this role, the unprecedented pressure exerted by the pandemic on every country's healthcare system has presented various challenges to nurses (e.g., increased patient volume, increased patient load, covid- protocols) that could affect their well-being and work performance. much worse, nurses are risking their lives in order to carry out their duties, causing intense fear of being infected or unknowingly infecting others. according to the icn, about or % of all accepted article confirmed cases of covid- worldwide were healthcare workers. of this figure, nurses had succumbed to the disease, a figure which was expected to continue rising. in the philippines, the department of health reported a total of healthcare workers infected with and deaths. among these confirmed cases, were nurses (department of health, a) . to effectively play their role during this pandemic, it is essential for nurses to maintain their psychological and mental health (mo et al., ; catton, ) ; however, the literature has shown that the emergence of covid- has significantly impacted the psychological and mental well-being of nurses. vast amounts of evidence have shown a significant association between the covid- outbreak and adverse mental health issues such as stress or burnout, depression and anxiety (wu et al., ; nemati et al., ; mo et al., ) . the severity and fatality of and susceptibility to disease can create or intensify anxiety and fear among nurses, potentially affecting their health and well-being and work effectiveness during times of infectious epidemic crisis (ahorsu et al., ) . in addition, frontline nurses, particularly those who work directly with coronavirus patients, often witness patients suffering and dying, impacting their emotional health and causing compassion fatigue (alharbi et al., ) and post-traumatic stress manifestations (kameg, ) . in a study conducted by labrague and de los santos ( ), . % of frontline nurses were found to have dysfunctional levels of anxiety related to covid- pandemic. a systematic review of studies has shown a higher prevalence of anxiety and depression in nurses than in other frontline healthcare workers (pappa et al., ) and the general population (mo et al., ) . hence, supporting the nursing workforce during the covid- pandemic is of paramount importance. since the onset of the coronavirus disease in november , a huge number of studies have been conducted and published navigating the effects of the disease outbreak on mental health among nurses and other healthcare workers. however, despite the increasing number of studies on the topic, none have been conducted to examine how these covid- -related mental consequences influence frontline nurses' work outcomes. as unmanaged anxiety or fear related to covid- may potentially lead to long-term effects on nurses' work performance and job satisfaction, leading to frequent absenteeism and eventual turnover (lee et al., ; , it is critically important to examine whether frontline nurses' fear of covid- contributes to psychological distress, work satisfaction and intent to leave their organisation and the profession. findings of this study will provide inputs for policymakers and this article is protected by copyright. all rights reserved nursing administrators on how to effectively support the mental health of frontline nurses and sustain a well-engaged nursing workforce particularly during this time of pandemic. a cross-sectional research design was employed, using five standardised scales. frontline registered nurses employed in hospitals in the philippines were included in the study. these hospitals, comprised of public hospitals and private hospitals, were designated as covid- referral hospitals by the department of health to deliver services and manage confirmed covid- cases with severe and critical symptoms. since the onset of the pandemic, the department of health mandated all hospitals in the country to activate its health emergency incident command system for effective management and control of the coronavirus disease. this includes activating guidelines and protocols on isolation measures, treatment guidance, training of staff on the use of personal protective equipment (ppe), patient care management, sample collection and handling, and waste management (department of health, b) . these guidelines and protocols are regularly communicated to the entire hospital staff through staff emails, newsletters, brochures, and small ward meetings. to qualify to participate in the study, participants needed to be registered nurses (rns) who hold either a full-time or contracted job status and currently work in a private or public hospital that provides services to coronavirus patients. using the g power program, power analysis showed the required sample size of nurses was to achieve an % power, where alpha was set at . and a small effect size at . (soper, ) . the small estimated effect size was chosen to ensure that a large sample was collected to detect meaningful correlations between variables. survey questionnaires were distributed to nurses and responses were received ( % return rate). the fear of covid- scale was used to examine nurses' apprehension about covid- (ahorsu et al., ) . this -item unidimensional scale was answered by nurses using a point likert scale which ranged from (strongly disagree) to (strongly agree). this scale is the most widely utilized instrument to measure fear of covid- and has been used by several researchers from different disciplines (bakioglu et al., ; gritsenko et al., ; reznik et al., this article is protected by copyright. all rights reserved ). further, it is easy to use and administer, making it suitable for this study. the composite score ranged from to , with a higher score indicating greater fear of covid- . previous research reported excellent predictive validity and reliability (α = . ) of the scale (ahorsu et al., ; gritsenko et al., ) . the cronbach's α of the scale in the present study was . . the job stress scale (jss) was used to assess nurses' experience of psychological distress while carrying out their work (house & rizzo, ) . nurses answered each item on the scale using a -point likert scale which ranged from (strongly disagree) to (strongly agree). the scale demonstrated excellent predictive validity and reliability (α = . ) (house & rizzo, ) . the internal consistency of the scale in the present study was . . the job satisfaction index (jsi) was used to assess nurses' satisfaction with their current work (schriesheim & tsui, ) . this -item scale consisted of items reflecting the essential job elements: work, organisational support, co-workers, wage or salary and career development. nurses answered each item using a -point likert scale which ranged from (strongly disagree) to (strongly agree). previous research reported excellent validity and reliability (α = . ) of the scale . the internal consistency of the scale in this study was . . the jss and jsi are well validated scales and have been widely used as measures of work contentment and psychological distress both in nursing and non-nursing studies, making it appropriate for this study satici et al., ) . two single-item measures of turnover intention were used to assess organisational and professional turnover intentions (o'driscoll & beehr, ) . professional turnover intention was assessed by the item "given the current situation, i am thinking about leaving nursing as a profession". organisational turnover intention was assessed by the item "given the current situation, i am thinking about leaving this healthcare facility". this scale was deemed appropriate for this study as it is short, easy and convenient to use, and has been validated in many nursing studies lavoie-tremblay et al., ) . nurses rated each item on a likert scale ranging from (strongly disagree) to (strongly agree). the test-retest reliability result of the items in the current study was . , higher than those in previous research (α = . ) . this article is protected by copyright. all rights reserved the ethical clearance of the study was granted by the institutional research ethics committee of samar state university. permission for data collection was sought from nurse directors from the identified hospitals prior to the actual collection of data. participants were screened according to pre-determined selection criteria and written consent was sought. after collecting the participants' written consent, the survey questionnaires enclosed in a sealed packet were handed to the respondents. participants were oriented individually before the survey questionnaires were completed to inform them of the nature of the research, its objectives, the potential benefits and risk involved in the study, and instructions on how to complete the questionnaires. the respondents were asked to complete the questionnaires during their free time and were given to minutes to complete the survey. instead of using their names, participants were assigned unique codes to ensure confidentiality. the lead researcher entered the data collected into a database secured with a password. hard copies of the questionnaires were kept in a secured cabinet. data were collected from march to may . analysis of the data collected was performed using the spss version software program (ibm corp., armonk, ny, usa). percentages, means and standard deviations were the descriptive statistics used. the pearson's r correlation coefficient, analysis of variance (anova) and independent t-test were used to identify correlations between the nurse, unit and hospital characteristics and fear of covid- . multiple linear regressions (enter method) were employed, after checking for the multicollinearity and normality of the data, to identify which variables could explain the impact of fear of covid- on nurse job outcomes. the level of acceptable significance was set at p < . . a total of nurses were included in this study. the mean age of the participants was . years. the majority of the participants were female (n = ), unmarried (n = ) and held baccalaureate degrees in nursing (n = ). the average nursing experience was . years, while the average tenure in the present organisation was . years. the vast majority of nurses - . % (n = )were aware of the existing workplace protocol related to covid- ; accepted article however, less than % (n = ) reported attending covid- -related training. the complete details of nurse characteristics are shown in table . the composite score for the fear of covid- scale was . (sd: . ), which was above the midpoint. for the job satisfaction and psychological distress scales, the composite scores were . (sd: . ) and . (sd: . ) respectively. the composite scores for the organisational and professional turnover intention measures were . (sd: . ) and . (sd: . ) respectively ( table ). the independent t-test showed a significantly higher mean scale score on the fear of multiple regression analyses were conducted to examine the influence of fear of covid- on nurses' job satisfaction, psychological distress, organisational turnover intention and professional turnover intention (table ). after adjusting for nurse/unit/hospital characteristics, an increased level of fear of covid- was associated with decreased job satisfaction (β = - . ; p = . ), increased psychological distress (β = . ; p = . ) and increased organisational (β = . ; p = . ) and professional (β = . ; p = . ) turnover intentions. a unit of increase in the composite score of fear of covid- was associated with a decrease in job satisfaction by . points. an increase in psychological distress by . was observed for this article is protected by copyright. all rights reserved a unit of increase in the composite score of fear of covid- . further, increased organisational ( . points) and professional ( . points) turnover intentions were observed for a unit of increase in the composite score of fear of covid- . this study investigated the influence of fear of covid- on frontline nurses' job satisfaction, psychological distress, organisational turnover intention and professional turnover intention. to our knowledge, this is the first study to investigate such a relationship, thus contributing key results from this career area in the field of nursing management and leadership. overall, the obtained mean scale score for the fear of covid- measure in the present study was . (sd: . ), which was above the midpoint. due to the lack of studies involving the nurse population, comparison was not possible. however, when the study results were compared to studies of the general population, it was revealed that the mean score in the present study was higher than those reported in russia ( . ) , belarus ( . ) , turkey ( . ) (bakioglu et al., ) and japan ( . ) (masuyama, shinkawa & kubo, ) . since frontline nurses are directly involved in patient care, their risk of contracting covid- is higher than the general population. this could contribute to their feelings of apprehension or fear of being infected or unknowingly infecting others, including their family members or friends. further, pandemic-related concerns such as increased patient volume and patient load, provision of coronavirus-related precautions (maben ), social distancing and community quarantine can intensify fears among nurses, affecting their psychological and emotional well-being and their work performance. healthcare institutions such as hospitals are frontline institutions during any disaster or disease outbreak. a well-planned workplace protocol should be in place, containing sets of actions relevant to disaster or disease outbreak, such as guidelines for caring for affected patients, safety practices when handling patients, relevant training, response plans and collaboration with other agencies at the local and national level (hirshouer et al., ) . as nurses are frontline health workers, it is essential that they are oriented and familiar with the content of workplace protocol; they should be knowledgeable on and skilful in carrying it out (ben natan et al., ; labrague et al., ) . in this study, a significant proportion of nurses ( . %) reported being aware of the existence of workplace protocol related to covid- . this this article is protected by copyright. all rights reserved result contrasts with results in previous research, in which many nurses (> %) working in hospitals were unaware of the existing workplace protocol related to disaster, emergency and disease outbreak (labrague et al., ) . higher awareness of workplace protocol related to covid- may be attributed to the extensive campaign carried out by the philippine health agencies to adequately prepare hospitals in the country for the covid- pandemic. hospitals were encouraged to develop covid- protocols based on the standards set by the world health organization. during a disease outbreak, nurses are often given new roles and are compelled to carry out added tasks, which, in some instances, may be beyond the scope of their usual nursing role (gebbie & qureshi, ) . hence, adequate training is a critical component of nurses' readiness and competence in any disaster or disease outbreak response. in this study, attendance of covid- -related training was identified as a significant predictor of fear of covid- : nurses who reported having attended such training experienced decreased levels of fear of coronavirus than those who did not. this result supports previous studies highlighting the role played by training, drills and exercises related to emergency and disaster situations (including disease outbreak) in preparing nurses for disaster and infection outbreak response and management (labrague et al., ; labrague et al., ) . this result coincides with that of wu et al. in this study, increased scores on the fear of covid- scale were associated with increased scores on the psychological distress measure. although there is a lack of similar studies involving nurses, this relationship is in accordance with previous studies involving the general population (satici et al., ; bakioglu et al. ) . for instance, in a study involving turkish individuals, increased levels of fear of covid- were strongly linked to negative emotional states including anxiety, depression and stress (satici et al., ) . a study by bakioglu et al. ( ) showed a similar pattern: fear of covid- had a significant positive relationship with anxiety, depression and stress. while fear is considered helpful in motivating individuals to respond effectively to a given threat or stimuli, extreme and persistent fear may result in negative psychological reactions such as stress, depression and anxiety (gorman, ) . finally, fear of covid- was shown to decrease job satisfaction and increase organisational and professional turnover intention among frontline nurses. to the author's knowledge, this study is the first to empirically test the association between fear of covid- and nurses' well-being, contributing original knowledge on nursing science, particularly in the area of nursing administration. as a psychological reaction to a threatening situation or stimuli (gross & canteras, ) , fear associated with coronavirus may interfere with work performance in nurses, leading to higher levels of job dissatisfaction and increased intentions to leave the profession and the organisation. this result coincides with earlier studies in other sectors, in which workers who demonstrated high fear or anxiety found job-related events more stressful, affecting their overall performance and work satisfaction (mccarthy, trougakos & cheng, ; jones, latreille & sloane, ) . by addressing fear of coronavirus among nurses, nurse wellbeing will be improved, with increased job satisfaction, decreased psychological distress and lower turnover intention. caution should be maintained when interpreting and generalising study findings in light of the limitations identified. first, this study was conducted within one province of the country; the exclusion of nurses from other provinces may affect the generalisability of the findings. next, the research design used could be a limitation; a cross-sectional study design cannot establish a causal link between variables under investigation. while this study found significant associations between a few nurse variables and their rating on the fear of covid- scale, other factors this article is protected by copyright. all rights reserved such as work environment, staffing adequacy, hospital management and leadership, personal nurse competency, hospital resources, and patient volume and acuity may also play important roles in explaining their fear of the disease. therefore, it is recommended that future studies explore other personal and organisational variables that may induce and intensify nurses' fear of covid- . the findings of the study highlight the vital role of hospital and nurse administrators in supporting nurses during the pandemic through evidence-based education, training or interventions, and policy. as nonattendance of covid- training was linked with increased fear of coronavirus, it is imperative that hospitals formulate or develop covid- training plans to improve the capacity of nurses to effectively care for and manage coronavirus patients. this can be facilitated by using alternative platforms such as webinars, social media platforms or other video technologies in order to maintain social distancing. as job role predicted fear of covid- , with part-time nurses reporting increased fear of the disease, the provision of adequate peer and organisational support is vital to enhance this group of nurses' preparedness for and familiarity with the care of coronavirus patients and ward or organisational processes related to covid- . a buddy system where a part-time nurse is paired with a more seasoned colleague can help support part-time nurses during the pandemic crisis (maunder et al., ) . as excessive fear may intensify pre-existing mental health issues or provoke anxiety (colizzi et al., ) and eventually affect nurses' health and job outcomes (e.g., job satisfaction, turnover intention), supporting the mental, psychological and emotional health of nurses should be prioritised by nursing and hospital administrators. these measures may ultimately improve work satisfaction, enhance perceived health, reduce psychological distress and decrease turnover intention among frontline nurses. this can be accomplished by implementing measures to preserve and maintain the mental health of nurses. mental health professionals during pandemic situations are instrumental in effectively supporting the mental health of frontline nurses. psychotherapy and psychological treatment may provide nurses with appropriate support (sucala et al., ) . due to certain limitations regarding access to in-person mental health services, a novel approach such as telepsychiatry could provide psychotherapeutic management this article is protected by copyright. all rights reserved or interventions (canady, ) . further, the provision of psychological materials (e.g., books, journals on mental health), psychological resources and counselling or psychotherapy (kang et al., ) may improve frontline nurses' mental health during covid- . nursing staff should be oriented on how and where to access these psychosocial and mental health services, and access to these services should be facilitated. ensuring that nurses are always kept updated with the latest and most accurate information related to coronavirus reduces the fear and negative emotions associated with the disease. this information should include the nature of the causative virus, precautions to prevent transmission of the virus to the self and others, how to effectively use hospital resources and new trends in the management of coronavirus patients. equally important is ensuring that the members of the nursing team are given the same information related to the disease, as well as the hospital protocols when handling or managing patents afflicted with the diseases. frontline nurses should be provided with adequate break time to allow them to take care of themselves. collectively, these measures could curtail the negative impacts of this crisis and reduce fear among nurses. support from peers, colleagues, families and friends may improve the sense of safety and help alleviate fear in nurses . sharing their work experiences with others may be helpful in attaining adequate psychological or other support and improving their morale amid the pandemic (maben & bridges, ) . support from top management through the provision of a safe work environment, adequate ppe and other infection control supplies is vital to support nurses in their daily practices. further, professional nursing organisations should provide covid- -related resources to nurses, including information on mental and psychological well-being, and the provision of resilience, coping and stress management programmes. consistent with prior evidence involving the general population, our results suggest that filipino frontline nurses experience mild to moderate levels of fear of covid- . job status and attendance of covid- training were seen to explain the fear of covid- among frontline this article is protected by copyright. all rights reserved nurses, with part-time or contracted nurses and those who had not attended such training reporting increased levels of fear of covid- . further, higher levels of fear of covid- were associated with increased psychological distress, lower job satisfaction, decreased health perceptions and increased turnover intention. understanding the factors that contribute to the fear of covid- and its effects on nurse work outcomes is critical when designing and implementing measures to address nurses' needs and concerns. this article is protected by copyright. all rights reserved the potential for covid- to contribute to compassion fatigue in critical care nurses the fear of covid- scale: development and initial validation jordanian nurses' perceptions of their preparedness for disaster management fear of covid- and positivity: mediating role of intolerance of uncertainty, depression, anxiety, and stress nurse willingness to report for work in the event of an earthquake in israel 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validation of the japanese version fear of covid- scale among adolescents accepted article this article is protected by copyright. all rights reserved are anxious workers less productive workers? it depends on the quality of social exchange work stress among chinese nurses to support wuhan in fighting against covid- epidemic assessment of iranian nurses' knowledge and anxiety toward covid- during the current outbreak in iran. archives of clinical infectious diseases, (covid- ) prevalence of depression, anxiety, and insomnia among healthcare workers during the covid- pandemic: a systematic review and meta-analysis. brain, behavior, and immunity covid- fear in eastern europe: validation of the fear of covid- scale adaptation of the fear of covid- scale: its association with psychological distress and life satisfaction in turkey development and validation of short satisfaction instrument for use in survey feedback interventions, paper presented at the western academy of management meeting a-priori sample size calculator for multiple regression the therapeutic relationship in e-therapy for mental health: a systematic key: cord- - kdv y authors: yang, kwangmo title: big technology and data privacy date: - - journal: healthc inform res doi: . /hir. . . . sha: doc_id: cord_uid: kdv y nan in the amended act, pseudonymized information may be processed without the consent of data subjects for statistical purposes, scientific research, and the preservation of records for the public interest, and so forth. a specialized institution designated by the protection commission or a related administrative agency may combine pseudonymized information stored outside the organization. moreover, it may become possible to combine claim data of the national health insurance service or the health insurance review & assessment service with the patient information stored in hospitals. the amendment of the pipa follows the trend of the protection of personal information standards of developed countries. this means that it is also a change to meet the protection standards of the european union's general data protection regulation (gdpr) or the health insurance portability and accountability act (hipaa) of the united states. meeting strict gdpr personal data protection standards is tough, especially for the companies exporting to europe. therefore, korean laws have been amended to comply with the gdpr requirements to facilitate the export of local products abroad. the gdpr, like the tdb, also defines pseudonymized data as personal data and renders information no longer re-identifiable if there is no additional information [ ] . we may infer that the gdpr recommends pseudonymization to process and utilize data. the hipaa by the us government achieves the deidentification of protected health information through the expert determination method and safe harbor method [ ] . the expert determination method has the disadvantage that it is necessary to appoint an expert for each study, requiring more money and time investment. on the other hand, it also editorial this is an open access article distributed under the terms of the creative commons attribution non-commercial license (http://creativecommons.org/licenses/bync/ . /) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ⓒ the korean society of medical informatics has an advantage of having the flexibility to determine identification according to technological changes. each expert must document the methods and results of analysis and may be required to submit documents upon request by the office for civil rights. the safe harbor method is used for the de-identification or removal of personal information in accordance with the privacy rule of hipaa. if an individual is not identifiable even with the combination of removed data and other information, it is possible to freely collect and process information without the restrictions of the hipaa. while simplicity is an advantage, the downside is that the value of the data may be reduced. the gdpr and hipaa ensure the protection of personal information and allow the flow and use of health information. korean law has been amended in line with this trend; however, the law still has shortcomings. as many civil society organizations have pointed out, it is a great pity that the tdb does not have the profiling protection measures specified in the eu's gdpr. in a recent korean case, the government sent a text message for mandatory health checks to those who had been in itaewon and had access to the telecommunications base station for more than minutes during the massive outbreak of covid- from itaewon clubs. although this was to prevent spread of the epidemic, it makes one wonder whether the telecommunications company was obliged to disclose the list of names of individuals who had only been in the area of itaewon and not in the clubs. it would have been very controversial under a similar circumstance in europe. on march , , the united nations human rights council expressed concerns regarding profiling in modern society. it stated that individuals may be discriminated against through profiling and that individual rights are likely to be violated in digital environments [ ] . if these changes are permissible, it may undermine and interfere with the freedom of expression and opinion. the ambiguity and vagueness of the act needs improvement. according to the amended pipa, pseudonymized information may be processed without the consent of the data subjects for statistical purposes, scientific research, and the preservation of records for the public interest. in this context, the scope of consent is ambiguous. if literally interpreted, consent may be waived for for-profit organizations when collecting statistical data. some individuals may find it unacceptable to imply consent. also, it is unclear whether pharmaceutical companies undertaking clinical research to develop new medications or companies developing digital therapeutics are waived from obtaining consent and are free to use health information for scientific research. the korean government also has not made sufficient effort in communicating with korean citizens. we may refer to the case of the english care.data programme, a national datasharing initiative for health records, which was discontinued for a number of reasons. the majority of the uk healthcare services are publicly funded. the general practitioners (gp) of the national health service (nhs) are organized into regions, and each patient is designated to a gp for medical care. gps are contracted with the nhs and are paid by the nhs-funded budget. consequently, patients' health information is stored with gp clinics on-site and is not managed by health authorities. as a result, the care.data programme was introduced. essentially, the patients could opt out of the scheme if they wished not to disclose personal information to care.data. more than one million patients have opted out of the care. data programme because of lack of awareness of and trust in the project. soon after, the project was stopped. many reports claimed that poor communication was a major factor that resulted in the failure of the project. likewise, the changes made to the tdb should be actively communicated to korean citizens. the majority of the citizens do not understand the changes that the tdb will bring. experts are also unable to articulate what route should be taken. nevertheless, it will be a good starting point to transparently talk about why the tdb was amended and how the tdb can be improved. as we are facing the big technology paradigm of the big data era, more efforts should be made to ensure that individual data privacy is not infringed. kwangmo yang (https://orcid.org/ - - - ) three data bills [internet]. sejong, korea: ministry of culture, sports and tourism legal feasibility study and guidelines for the utilization of health insurance big data and the provision of health service personal information protection act ministry of government legislation european commission. eu general data protection regulation (gdpr) european commission; c us department of health & human services. guidance regarding methods for de-identification of protected health information in accordance with the health insurance portability and accountability act (hipaa) privacy rule us department of health & human services the right to privacy in the digital age the office of the high commissioner for human rights key: cord- -p teh a authors: simms, a; fear, n t; greenberg, n title: the impact of having inadequate safety equipment on mental health date: - - journal: occup med (lond) doi: . /occmed/kqaa sha: doc_id: cord_uid: p teh a background: concerns are being raised about the impact of inadequate safety equipment on the mental health of healthcare workers during the covid- medical response. aims: to assess the impact of inadequate safety equipment on the mental health of service personnel deployed on operations in order to better understand the impact on those working under the similarly demanding conditions of the covid- medical response. methods: self-report surveys were conducted in four operational environments with personnel providing data. surveys recorded data on socio-demographic, military and operational characteristics, mental health measures and specific occupational stressors. analysis through logistic regression explored the association between inadequate equipment and all other factors. results: a total of personnel provided data on their perceptions of the adequacy of their equipment, of which ( %) stated that they had a lot of concerns that they did not have the right equipment in working order. analysis found significantly greater odds of reporting symptoms of common mental health disorders (cmd), . ( . – . ), post-traumatic stress disorder (ptsd), . ( . – . ), poorer global health . ( . – . ) and emotional problems . ( . – . ) when individuals reported working with inadequate equipment. analyses remained significant when adjusted for confounding factors such as rank, sex and operational environment. conclusions: an individual’s perception of having inadequate equipment is significantly associated with symptoms of cmd, probable ptsd, poorer global health and increased reporting of emotional problems. this in turn may impact on their ability to safely carry out their duties and may have longer-term mental health consequences. there are frequent media reports and questions to the government relating to whether nhs and other key workers have sufficient equipment to safely carry out their roles. furthermore, concerns about the relationship between inadequate equipment and the mental health and deaths of healthcare workers have been raised by the british medical association (bma) [ ] and the royal college of nursing (rcn) [ ] . the health and safety executive (hse) define workrelated stress as an adverse reaction to excessive pressures or demands placed upon individuals [ ] . this is associated with presenteeism, a reduction in work productivity including poorer quality of patient care, increased staff turnover and mental health disorders [ ] . in / , workers in the uk suffered from work-related stress, depression or anxiety with . million working days lost [ ] . the uk armed forces have considerable experience of working in stressful environments, adapting to new threats at short notice, in unpleasant conditions for prolonged periods with limited resources. they have also carried out extensive research in order to better understand the stressors and mitigate against them [ ] . this paper examines the association between inadequate equipment and mental health using data from four military operations to further understand how this issue might affect healthcare workers in the demanding covid- environment. a total of military personnel were surveyed across four operational environments; iraq and afghanistan in [ ] and [ ] , respectively, and operations between the persian gulf and south atlantic in [ ] . each survey recorded socio-demographic details, military and operational characteristics, the -item general health questionnaire (ghq- ) [ ] and the post-traumatic stress disorder checklist-civilian version (pcl-c) [ ] . self-rated general health was assessed using the short form health survey (sf- ) [ ] . the survey also explored work-related stressors, specifically whether they were troubled by not having the right equipment in working order. a total of ( % responder rate) responded to the question asking whether they were troubled by having inadequate equipment, with ( %) endorsing the statement (table ) . analysis found significantly greater odds of reporting symptoms of common mental health disorders (cmd), . ( . - . ), post-traumatic stress disorder (ptsd), . ( . - . ), poorer global health . ( . - . ) and emotional problems . ( . - . ) when individuals reported working with inadequate equipment ( table ) . analyses remained significant when adjusted for confounding factors such as rank, sex and operational environment. this study found significant associations between the perception of having inadequate equipment and poorer mental health in personnel operating in an arduous environment, a situation similar to the current covid- response given the tangible threat, persistent pressure and uncomfortable working conditions. previous research shows that poorer mental health is often associated with significant functional impairment [ ] and has identified that healthcare workers are at an increased risk of presenteeism in relation to infectious illnesses [ ] . whilst poorer mental health may impact on their ability to carry out their duties efficiently and safely with catastrophic consequences to both staff and patients, the individual is also at risk of longer-term difficulties such as burnout [ , ] which is associated with depression [ ] and higher staff turnover [ ] . healthcare managers should be aware that staff who complain about poor equipment are at increased risk of poor mental health which may impair their ability to carry out their role safely. robust support processes should be put in place to mitigate this risk. what is already known about this subject: • concerns are being raised in the media about inadequate safety equipment for healthcare workers during the covid- response. • work-related stress is associated with presenteeism, poorer mental health and increased staff turnover. • the perception of having inadequate equipment has a significant association with poorer mental health within personnel working in demanding environments. what impact this may have on practice or policy: • the results suggest the need for robust psychological support is required to protect the mental health of all staff, especially those who feel that they have not been supplied with sufficient work-related equipment. adjusted for rank and sex. c adjusted for all above. stress and burnout warning over covid- how covid- is affecting nurses' mental health, and what to do about it how to tackle work-related stress. a guide for employers on making the management standards work work related stress, burnout, job satisfaction and general health of nurses work-related stress, anxiety or depression statistics in great britain the injured mind in the uk armed forces mental health of uk military personnel while on deployment in iraq mental health and psychological support in uk armed forces personnel deployed to afghanistan in and the mental health of deployed uk maritime forces user's guide to the general health questionnaire the ptsd checklist-civilian version (pcl-c) for dsm-iv the mos -item short-form health survey (sf- ): ii. psychometric and clinical tests of validity in measuring physical and mental health constructs the impact of posttraumatic stress disorder on impairment in the uk military at the time of the iraq war a systematic review of infectious illness presenteeism: prevalence, reasons and risk factors occupational variation in burnout among medical staff: evidence for the stress of higher status resilience, burnout and coping mechanisms in uk doctors: a cross-sectional study burnoutdepression overlap: a review burnout and health care workforce turnover key: cord- -cb u s s authors: bedford, juliet; farrar, jeremy; ihekweazu, chikwe; kang, gagandeep; koopmans, marion; nkengasong, john title: a new twenty-first century science for effective epidemic response date: - - journal: nature doi: . /s - - -y sha: doc_id: cord_uid: cb u s s with rapidly changing ecology, urbanization, climate change, increased travel and fragile public health systems, epidemics will become more frequent, more complex and harder to prevent and contain. here we argue that our concept of epidemics must evolve from crisis response during discrete outbreaks to an integrated cycle of preparation, response and recovery. this is an opportunity to combine knowledge and skills from all over the world—especially at-risk and affected communities. many disciplines need to be integrated, including not only epidemiology but also social sciences, research and development, diplomacy, logistics and crisis management. this requires a new approach to training tomorrow’s leaders in epidemic prevention and response. when nature published its first issue in , a new understanding of infectious diseases was taking shape. the work of william farr , ignaz semmelweis , louis-rené villermé and others had been published; john snow had traced the source of a cholera epidemic in london (although robert koch had not yet isolated the bacterium that caused it ). the science of epidemiology has described patterns of disease in human populations, investigated the causes of those diseases, evaluated attempts to control them and has been the foundation for public health responses to epidemic infections for over years. despite great technological progress and expansion of the field, the theories and practices of infectious disease epidemiology are struggling to keep pace with the transitional nature of epidemics in the twenty-first century and the breadth of skills needed to respond to them. epidemiological transition theory has focused mostly on the effects of demographic and socioeconomic transitions on well-known preventable infections and a shift from infectious diseases to non-communicable diseases . however, it has become clear that current demographic transitions-driven by population growth, rapid urbanization, deforestation, globalization of travel and trade, climate change and political instability-also have fundamental effects on the dynamics of infectious diseases that are more difficult to predict. the vulnerability of populations to outbreaks of zoonotic diseases such as ebola, middle east respiratory syndrome (mers) and nipah has increased, the rise and spread of drug-resistant infections, marked shifts in the ecology of known vectors (for example, the expanding range of aedes mosquitoes) and massive amplification of transmission through globally connected, high-density urban areas (particularly relevant to ebola, dengue, influenza and severe acute respiratory syndrome-related coronavirus sars-cov). these factors and effects combine and interact, fuelling more-complex epidemics. although rare compared to those diseases that cause the majority of the burden on population health, the nature of such epidemics disrupts health systems, amplifies mistrust among communities and creates high and long-lasting socioeconomic effects, especially in low-and middle-income countries. their increasing frequency demands attention. as the executive director of the health emergencies program at the world health organization (who) has said: "we are entering a very new phase of high-impact epidemics… this is a new normal, i don't expect the frequency of these events to reduce." . we have to act now but act differently: a broader foundation is required, enhancing traditional epidemiology and public health responses with knowledge and skills from a number of areas ( table ) . many of these areas have long been associated with epidemic preparedness and response, but they must now stop being seen as esoteric 'nice things to have', and instead become fully integrated into the critical planning and response to epidemics. this will require considerable changes by the global public health community in the way that we respond to epidemics today and how we prepare for and seek to prevent those of tomorrow. it will mean reshaping the global health architecture of the response to epidemics and transforming how we train new generations of researchers and practitioners for the epidemics of the future . the modern research culture-often shaped by the behaviour of funders-has required many researchers to specialize in narrow fields, with less emphasis on translation than on field-specific innovations. although this siloed landscape has brought major advances in global health, it is not fit for the transitional phase of epidemic diseases: rapidly evolving, high-impact events bring together communities, responders and researchers who do not routinely interact. different assumptions, cultures and practices, each of which may be widely accepted within a particular community, make working together in outbreak situations more challenging. fundamental to success is respect and understanding of the contribution each party brings. in a successfully integrated approach, we each have to realize that our knowledge and skills are a small part of a rapidly expanding toolkit (box ). we need to understand major trends in research and how and when they may influence the response to an epidemic, develop new research to strengthen the support that we can provide across other areas and learn to operate in multi-stakeholder situations-including, at times, as part of a critical debate to bring better practices to the fore. central to this approach must be the communities who are at risk and those affected by epidemics: local people are the first responders to any outbreak and their involvement in the preparation and response activities is essential. from communities, through local and regional health authorities, national public health institutes and international organizations-including many essential partners in sectors beyond public health-the integrated approach must be supported. the who, in particular, has a critical part to play, using its unique mandate not to lead every aspect of preparation, response and recovery, but to change its practices, facilitate integration with and among others, and ensure accountabilities are built in from the bottom to the top. a wave of cholera epidemics across europe in the s and s catalysed a new era of 'infectious disease diplomacy' globally. nations recognized that infections do not stop at borders and that therefore multilateral collaboration is essential to protecting citizens from lethal epidemics. the development of germ theory through the second half of the nineteenth century transformed ideas about the causes of infections, informing scientific research as well as clinical responses. scientific understanding translated into vaccines and antibiotics, while programmes for child health, hygiene, clean water and sanitation became common in the twentieth century. as a result, childhood diseases such as measles and mumps became rare, smallpox was eventually eradicated and polio was eliminated from all but a handful of countries . many people thought that infectious diseases would soon be history. sir frank macfarlane burnet is often cited for his remark in the s that, with the emergence of new diseases being a distant prospect, "the future of infectious diseases will be very dull" . although the focus in high-income nations turned to non-communicable diseases, which constituted a considerable and increasing burden on the health of their citizens, infectious diseases did not disappear. some endemic infections such as malaria and tuberculosis were not susceptible to elimination strategies, and new diseases with epidemic and pandemic potential emerged. ebola virus disease was first identified in the s, hiv/aids in the s, nipah virus in the s, sars and mers at the start of the twenty-first century, and many more have since been identified. far from becoming 'very dull', the field of infectious disease epidemiology has sometimes struggled to adapt: as late as , respected researchers used a nineteenth century 'law' of epidemiology to make predictions about the aids epidemic-these turned out to be vast underestimates . advances in other fields gave epidemiology the chance to evolve. in , when the editors of the international journal of epidemiology provocatively asked whether it was time to 'call it a day' given the putative power of genomics to explain diseases over the capacity of epidemiologists to describe them, their conclusion was that it had the potential to positively transform epidemiology as much as the rise of germ theory a century earlier. at least pathogens that affect humans have been identified as emerging, re-emerging or evolving since the s , while increasing rates of antimicrobial resistance threaten to make formerly controlled infections, such as malaria, untreatable -this also limits our ability to control their epidemic potential. the demographic transition is driving much of this: human society is becoming more urban than rural for the first time in our history, bringing large numbers of people (and often animals) together in densely populated areas . agricultural and forestry practices are changing the relationships between people, animals and our respective habitats . travel is more accessible around the world, advances in computer science and computing speeds have led to a number of applications of artificial intelligence across society . applications in epidemiology include tracking online searches about disease symptoms to aid early detection of epidemics, although more sophisticated methods may be required before artificial intellegence becomes a reliable detection tool . crystallography modern x-ray diffraction and electron microscopy can reveal structures of viruses and antibodies in such detail that it is possible to identify specific sites of vulnerability on the virus. a previous study showed how such techniques identified an antibody that was much more potent against respiratory syncytial virus than the only currently available intervention . developing vaccines for emerging infectious diseases has many challenges, including the time it takes, a limited market and strict regulatory requirements for products that will be given to healthy people . platform technologies use one underlying approach with standardized processes and some antigen-specific optimization to speed up both development and manufacture of vaccines. for example, vector-based platforms combine an antigen, or a gene for an antigenic protein or peptide, in a virus-like particle or liposome. such platform technologies have the potential to deliver vaccines a few months after an emerging pathogen is identified and sequenced, rather than years . review so migration, trade and tourism bring more people into contact and thus affect disease transmission . climate change has many effects on ecosystems and environments, not least in changing the habitats and migratory habits of disease vectors . states with weak health systems are far less likely to cope with or recover from multiple emergent demands without damaging routine services . inequalities , inequities and distrust in national structures and institutions compound people's vulnerabilities . conflict increases the risk of epidemics and makes responding to them close to impossible . since , there have been several outbreaks of ebola (including the two biggest in history), not to mention outbreaks of sars, mers, nipah, influenza a subtype h n , yellow fever, zika and the continued spread of dengue. epidemics overlap and run into each other, yet the world is not currently equipped to cope with this increasing burden of multiple public health emergencies. preparing for epidemics, therefore, requires global health, economic and political systems to be integrated just as much as infectious disease epidemiology, translational research and development, and community engagement. epidemics represent shared risks that cross borders and all of society. health systems, routine care, trust in governments, travel, trade, business-all are disrupted during an epidemic. with such broad risks, the preparation and response must be nationally owned and led, internationally supported and undertaken with a whole-of-society approach. some initiatives have started to build frameworks for this to happen in a coordinated way. for example, the who's pandemic influenza preparedness framework brings together nation states, industry, other stakeholders and the who to implement a global approach to pandemic preparedness and response . a focus must be building coordinated regional and country expertise, resources and capacity through national and regional public health institutions . this brings its own challenges-governance of institutions, leadership, collaborations and interventions have to be impeccable or misconduct can thrive . unwelcome in itself, misuse of funding, resources or people within efforts intended to support an epidemic response will also undermine trust in the organizations that respond to an outbreak and, in turn, prolong the outbreak. key governance components include drafting policies in advance and being willing to implement those policies for data collection and sharing during epidemics. they must be flexible enough to enable affected communities and nations to retain ownership of the response, while drawing on international expertise to find the best possible response. governance should also include processes for vaccine and therapeutic approvals during outbreaks. however, it is clear that the centre of gravity for leadership, governance and implementation must be where the need is greatest if these are to truly deliver. in , julian tudor hart proposed the inverse care law: "the availability of good medical care tends to vary inversely with the need for it in the population served." . an analogue of the inverse care law can be applied to public health and epidemiology. expertise in these fields has traditionally gravitated towards centres of excellence in europe and the united states. of course, high-income countries are not immune to the disruption associated with epidemics, especially in an era of misinformation and growing mistrust in authorities and public health initiatives. however, the centre of gravity must shift so that globally representative distributed networks of collaborating centres can jointly ensure coverage in the regions that urgently need these skills on the ground . international collaborations remain important; however, strengthening epidemiology, public health and laboratory capacity in low-and middleincome countries is essential . collaborative interventions should not be limited to when there is a major outbreak, but be integrated into regular interactions. capacity, resources, expertise and governance can be supported by the increasing role for regional and national centres of disease control. the us centers for disease control (cdc) lends its expertise all around the world in addition to protecting the us population. in , the european cdc started, followed by the china cdc in and by the africa cdc in . although more can be done to improve data sharing and access to laboratories, the networks and connections between these centres have strengthened all of their work, as well as having a positive effect on public health systems in low-and middle-income countries. during the pan-european wave of cholera in the s, there were riots across the continent: doctors, nurses and pharmacists were murdered, hospitals and medical equipment destroyed . similar reports today usually come from communities that have not had positive prior interactions with public health initiatives, and thus the encounter with national or international teams who arrive only in response to a 'new' disease means that trust can never be assumed and has to be earned on both sides. engagement needs to start before an outbreak-ensuring that patients, their families and their communities are at the centre of all public health is essential for the successful prevention and response to epidemics. there is no public health without the support of the community. for example, the early detection of disease events will be improved if more national and regional public health institutions establish community event-based surveillance systems. communities are the first to know when something unusual happens -therefore training and mobilizing community volunteers to report such occurrences is a costeffective way to rapidly detect diseases and contain them at the source. this will also help to sustain engagement between communities and the organizations that respond to outbreaks. furthermore, improved information flow between the community and the public health system should provide a better understanding of local social networks to complement other means of tracking chains of transmission between individuals and places. this can be the community themselves, or it might be veterinarians who see clusters of sick animals, or nurses and doctors who care for patients in primary care-or it may be teams that are often forgotten in public health initiatives, such as those working in critical care facilities; it is striking how the first cases of nipah, sars, mers and influenza a subtype h n were all first identified by clinical teams in critical care facilities. an inclusive, whole-of-society approach is challenging, and the challenges may be magnified in a conflict or post-conflict zone. wars and conflicts not only increase the risk of epidemics as people move to escape violence and health services become harder to maintain , but also make public health responses vulnerable to interruption, thus making them less effective. then, miscommunication, mistrust, disease and violence can fuel each other in a vicious cycle. engaging local communities remains the highest priority, even in unstable contexts such as north kivu and ituri provinces of the democratic republic of the congo (drc) , where an ebola epidemic started in august . it seems inevitable that responding to epidemics in politically unstable environments will become more common, and skilled negotiators and peacekeepers will have to be better integrated in response teams. equally essential, therefore, will be an improved understanding of these challenging operational contexts among affected communities and external responders alike. social scientists have long applied their skills and knowledge in epidemic responses, although their roles have become more visible in recent years . by focusing on communities, social science humanizes the epidemic response , helps to increase understanding of context and may uncover associations between the context or local practices and the risk of transmission. the social science in humanitarian action platform has successfully produced rapid reports and briefings on regions in which an epidemic has been identified, and the global research collaboration for infectious disease preparedness includes a social science research funders' forum to 'propel research in this area' , acknowledging that its integration in the preparation and response to outbreaks is often missing or added as an afterthought to solve a problem that could have been forseen. there is still much to learn about how epidemic responders and social scientists can make the most of each other's expertise and how data from social science can fit into the wider information architecture of epidemic response. as an example, behavioural surveillance will be critical in twenty-first century responses to disease outbreaks . just as behavioural surveillance to improve the understanding of hiv was crucial in identifying high-risk groups for hiv infection, so human behaviours will continue to be important as we respond to future infectious diseases. for instance, the ebola virus outbreak in west africa probably began before december , but it took several months before hospital transmission and traditional burial practices were found to be the leading causes of its rapid spread. the increasing prevalence of mobile phones, wireless internet connectivity and social media activity raises the possibility of using these tools to gather data for epidemiological studies, diagnostics , population mobility during an ebola epidemic or influenza incidence in real time . future developments in predictive technology, machine learning and artificial intelligence will bring more opportunities to move towards 'precision public health' (box ). the use of data from people is becoming strictly controlled, however, and it will be a challenge to persuade countries to invest in a new surveillance system, for example, before its general effectiveness has been demonstrated at a country level . even then, technology-based solutions should be integrated with community-based programmes and other existing epidemic preparedness and response systems because surveillance is more effective when standardized among different countries, districts and communities. to this end, suites of guidance and open-access standardized tools are being developed for reporting cases of disease, as well as consent forms, standard operating procedures and training materials , properly validated diagnostic assays and access to quality-assurance panels in public and veterinary health. the rising trend of engaging citizens in data gathering is also welcome-the use of mosquito-recognition apps enables the collection of data far beyond the capacity of routine mosquito surveillance . this way, citizens feed information into the public health system and the feedback loop offers a fast and direct way to provide citizens with details of potential actions that they can take. as well as potentially supporting diagnosis and surveillance , the fast-developing field of genomic epidemiology can yield information to track the evolution of a virus such as ebola during an epidemic , . there will be times when it can detect outbreaks better than traditional epidemiology, illustrating the need to have these tools available in the same toolbox. during the large lassa fever outbreak in nigeria in , real-time genomic sequencing provided clear evidence that the rapid increase was not due to a single lassa virus variant, nor attributable to sustained human-to-human transmission. rather, the outbreak was characterized by vast viral diversity defined by geography, with major rivers acting as barriers to migration of the rodent reservoir . these findings were crucial in containing the outbreak. developing and sustaining the capacity to conduct real-time sequencing with adequate bioinformatics analyses at regional and national levels will be challenging in low-and middle-income countries. moreover, investments in relatively high-tech capacity (such as real-time sequencing) are competing with other, arguably more fundamental needs, such as equipment and training in primary laboratories. political engagement must be nurtured between epidemics: it is not enough to offer technological and laboratory support during a crisis, even with the promise of building capacity, if the political will is not there. however, with proper preparation, and accessible and trusted data sharing and governance mechanisms, laboratories with limited resources may be able to leap-frog into the twenty-first century , . vaccination is one of the most effective public health interventions and innovative strategies for research and development of vaccines, such as using ring vaccination as a trial design during ebola epidemics since - , must be encouraged. at the start of the - epidemic in west africa, vaccine candidates were already in development, based on a long history of preclinical research, although a lot of work was still required to get clinical trials underway in time to be useful . in , when zika was first internationally recognized as a pathogen that could cause birth defects , there was hardly any research and no vaccines in late-stage development. two-and-a-half years later, results from three phase i clinical trials had been reported , although challenges remained for further development. the lack of a profitable market for such products means that pharmaceutical companies lack the incentives to push this work between epidemics. initiatives such as the coalition for epidemic preparedness innovations are attempting to positively disrupt financing models for vaccines against epidemic diseases , and stockpiles of meningococcal vaccine, yellow fever vaccine and oral cholera vaccine are maintained by the international coordinating group to minimize potential delays due to limited manufacturing capacity . similarly, if investigational treatments or vaccines are to be used as part of the response to an epidemic, ethical protocols for managing informed consent and introducing them in clinical settings must be planned in advance with at-risk communities (box ). trial designs precision medicine refers to the use of genomic sequencing to retrace the specific course of a disease in individual patients, with the aim of being able to choose the best treatment option for each person. in public health, the analogous idea of precisely directing the right intervention to the right population is equally appealing. the potential of such an approach has been illustrated by the identification of two areas in the united states in that were at risk of zika transmission . rather than the whole country, or even only florida, being declared at risk, these two areas each measured less than km , and the response focused only on these specific neighbourhoods. by contrast, a campaign against yellow fever, also in , defined risk 'at the level of entire nations'. a broad interpretation of precision public health incorporates many different types of data to increase the power of epidemiology . such data would not only include genomic information, but also satellite imaging, mobile phone data, social media use data and so on. for example, a study published in combined epidemiological surveillance data, travel surveys, parasite genetics and anonymized mobile phone data to measure the spread of malaria parasites in southeast bangladesh . a retrospective analysis of mobile phone call data in sierra leone from showed how it might have been used to assess the impact of travel restrictions on mobility during the ebola epidemic . the principle of selecting the most relevant information from all available data seems within the scope of good epidemiological practice already. the challenge is recognizing and incorporating new types of data when they become available. should be created as soon as the option becomes viable. the essential consideration is how the resulting data can add to previous trials and influence the approach to trials in future epidemics. for example, research during the - ebola epidemic enabled progress on therapeutic agents that are now being trialled in the ongoing outbreak in drc . scientific progress during and between epidemics must be matched by other workstreams, such as the preparation of supply chain logistics and communication with at-risk populations. plans have to be made for a series of future outbreaks, enabling adaptive, multi-year, multi-country studies . similar plans are needed for continual preclinical research to ensure that future vaccine and therapeutic pipelines will be filled. the term 'one health' is used to acknowledge that human, animal and ecosystem health are tightly interconnected and need to be studied in the context of each other (fig. ) . changes in the environment-whether natural or anthropogenic-affect interactions between pathogens, vectors and hosts in multiple and complex ways, making the emergence or decline of endemic, epidemic and zoonotic diseases difficult to predict, while epidemics of animal diseases can challenge a community's access to food. the fact that pools of viruses, bacteria and parasites are maintained in wild and domesticated animals makes surveillance of potentially zoonotic diseases an intrinsic part of one health epidemic planning. many agencies and nations around the world now use prioritization tools such as those developed by the us cdc or the united nations (un) food and agriculture organization (fao) to identify and prioritize zoonotic diseases of concern. an early precedent was a joint consultation on emerging zoonotic diseases by the who, the fao and the world organisation for animal health in . understanding disease ecology in the zoonotic reservoir could potentially lead to ways to predict the risk of human disease, thus providing the basis for smart early-warning surveillance systems. individual countries with limited resources for epidemiological studies and epidemic preparation and response must decide their own priorities. however, infectious diseases do not respect borders. similarly, the interdisciplinary nature of one health means there are several different lenses through which different sectors assess risks and priorities. for one health approaches to work, these multiple perspectives must be taken into account, whether human health or animal health, ecology or social sciences . epidemics do more than cause death and debilitation: they increase pressure on healthcare systems and healthcare workers and draw resources from services not directly linked to the epidemic. this can leave a legacy of distrust between people, governments and health systems, although more-positive outcomes have been found to strengthen relations between communities and public authorities. the full social and economic costs of the ebola outbreak in west africa have been estimated to be as high as us$ billion when including the effect on health workers, long-term conditions suffered by , ebola survivors, and costs of treatment, infection control, screening and deployment of personnel beyond west africa. as healthcare resources became increasingly allocated to the ebola response, hospital admissions fell and deaths from other diseases rose markedly, adding us$ . billion to the estimated cost. such pressure can be withstood in high-income countries with strong health systems, but in low-income countries the pressure can quickly reach a breaking point. ebola killed almost . % of doctors, nurses and midwives in guinea, . % in sierra leone and just over % in liberia . this is compared to mortality between . % and . % of the whole population of these countries. estimates of the effect of this loss on maternal mortality suggest that thousands more women may have died in childbirth each year since the epidemic ended. beyond the tragic deaths of so many healthcare workers, people were less likely to use health services for children or adults during the epidemic, suggesting decreased trust or even fear of healthcare settings . more recently, in some areas affected by the ebola outbreak in drc, the introduction of free non-ebola healthcare led to unprecedented demand. however, healthcare facilities box in , the prevent project received wellcome funding to provide ethics guidance "at the intersection of pregnancy, vaccines, and emerging and re-emerging epidemic threats" . this was in response to the newly recognized association between infection with zika virus during pregnancy and microcephaly in the newborn. developing a vaccine was an obvious route to explore, but many researchers felt that they could not conduct clinical trials with pregnant women because it is generally assumed that the risk to the woman, the fetus or both outweighs any potential benefit. however, as heyrana et al. argue: "preventing pregnant women from participating in clinical trials is well intentioned but misguided." . prevent rapidly developed guidance for including pregnant women and their babies in zika vaccine research , and has since extended their scope to "a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens." . integrating ethics in the preparation and response to epidemics does not close off avenues of research; it opens up possibilities and expedites progress. were not given sufficient additional resources to care for the number of people, which may have contributed to nosocomial infections. survivors, too, need to be cared for long after the epidemic is declared over. a cohort of more than , children is growing up in brazil after being born with microcephaly because their mothers were infected with zika during pregnancy. tracking the development of these children increases understanding of the effects of zika infection and helps to define what medical and social support the affected families may need as many of the children will grow up with severe developmental delays . the challenges posed by twenty-first century epidemics are real and changing: future epidemics will be fuelled by conflict, poverty, climate change, urbanization and the broader demographic transition. in our response we must consider epidemics not as discrete events, but rather as connected cycles for which we can prepare, even if we cannot predict specific outbreaks. the challenge is then to choose the right response at the right scale in the right area at the right time. there needs to be a greater emphasis on absorbing and using positive lessons from each episode and avoiding those that led to negative outcomes . the way that we train practitioners and researchers working in all fields relevant to today's epidemic landscape has to change. a modern approach that is capable of characterizing epidemics and the best ways to control them must go beyond a narrow definition of epidemiology that sustains artificial barriers between disciplines. instead, it must be able to integrate tools and practices from a diverse range of established and emerging scientific, humanistic, political, diplomatic and security fields. we believe that such an approach needs to become the norm for the curriculums of schools of public health around the world. as well as training new generations of epidemiologists so that they have the skills, knowledge and networks to recognize and make use of every tool available to help them to do their work effectively, the entire architecture of the response to epidemics has to be adapted. only then will we be able to maintain the comprehensive and effective response-including prevention and research-needed to stop epidemics and protect people's lives, no matter what the circumstances. celebration: william farr ( - )-an appreciation on the th anniversary of his birth rediscovering ignaz philipp semmelweis ( - ) louis-rene villerme ( - ), a pioneer in social epidemiology: re-analysis of his data on comparative mortality in paris in the early th century john snow's legacy: epidemiology without borders this is a wide-ranging meeting report that places modern epidemiology in the context of the past two hundred years and highlights the importance of bringing in new disciplines, remaining open-minded and using those skills across a wider range of societal issues than are traditionally considered public health robert koch and the cholera vibrio: a centenary epidemiology for the uninitiated the epidemiologic transition. a theory of the epidemiology of population change large ebola outbreaks new normal, says who applied epidemiology and public health: are we training the future generations appropriately? managing epidemics: key facts about major deadly diseases ignaz semmelweis, carl mayrhofer, and the rise of germ theory history of vaccination the global eradication of smallpox from emergence to eradication: the epidemiology of poliomyelitis deconstructed natural history of infectious disease p farr's law applied to aids projections epidemiology-is it time to call it a day? global rise in human infectious disease outbreaks pandemics, public health emergencies and antimicrobial resistance -putting the threat in an epidemiologic and risk analysis context how urbanization affects the epidemiology of emerging infectious diseases microbial evolution and co-adaptation: a tribute to the life and scientific legacies of joshua lederberg travel, migration and emerging infectious diseases understanding the link between malaria risk and climate the ebola outbreak, fragile health systems, and quality as a cure health inequalities and infectious disease epidemics: a challenge for global health security historical parallels, ebola virus disease and cholera: understanding community distrust and social violence with epidemics war and infectious diseases: challenges of the syrian civil war pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits (who how africa can quell the next disease outbreaks the ability to prevent, detect and respond to any health issues will always depend on the local capacity and although international partners can bring complementary expertise and resources, it is the local capacity that is critical; in this article, the authors argue for national investment in public health, health systems, science and local leadership un health chief orders probe into misconduct the inverse care law agenda setting, research questions and funding for biomedical research has historically been led from northern hemisphere countries in an unequal northern-southern hemisphere relationship science granting councils in sub-saharan africa: trends and tensions international federation of red cross and red crescent societies. community-based surveillance: guiding principles conflict and emerging infectious diseases institutional trust and misinformation in the response to the - ebola outbreak in north kivu, dr congo: a population-based survey application of social science in the response to ebola towards people-centred epidemic preparedness and response: from knowledge to action anthropology in public health emergencies: what is anthropology good for? launching a new era for behavioural surveillance integrated biological-behavioural surveillance in pandemic-threat warning systems taking connected mobile-health diagnostics of infectious diseases to the field population mobility reductions associated with travel restrictions during the ebola epidemic in sierra leone: use of mobile phone data national and local influenza surveillance through twitter: an analysis of the - influenza epidemic social media and internet-based data in global systems for public health surveillance: a systematic review isaric. protocols & data tools enhancing early warning capabilities and capacities for food safety real-time, portable genome sequencing for ebola surveillance infection control in the new age of genomic epidemiology genomic surveillance elucidates ebola virus origin and transmission during the outbreak genetic diversity and evolutionary dynamics of ebola virus in sierra leone genomic analysis of lassa virus during an increase in cases in nigeria the integration of genomics and other types of data into the surveillance, prevention and response of epidemics is critical and can help to transform the ability to enhance public health; although the tools are now available, it will be key to ensure that these new approaches are fully integrated and not seen as esoteric ivory tower research, but instead as an essential component of twenty-first century epidemiology, public health and epidemics-the next generation of leaders need to be efficacy and effectiveness of an rvsv-vectored vaccine in preventing ebola virus disease: final results from the guinea ring vaccination, open-label, cluster-randomised trial (ebola Ça suffit!) a seminal study that shows that ring vaccination could be used in the midst of a devastating ebola epidemic and, furthermore, that innovation research can be conducted in an epidemic, trial designs can be adapted without compromising scientific integrity and that ebola can be prevented through vaccination ethical rationale for the ebola "ring vaccination" trial design ebola vaccination in the democratic republic of the congo insights from clinical research completed during the west africa ebola virus disease epidemic gone or forgotten? the rise and fall of zika virus current status of zika vaccine development: zika vaccines advance into clinical evaluation cepi: preparing for the worst the development of global vaccine stockpiles the ebola clinical trials: a precedent for research ethics in disasters it is an ethical imperative to consider and implement research in an epidemic setting as, for many epidemic diseases, it is the only time at which to conduct the research that will inform and improve the lives of the individuals affected during epidemic and to ensure that future generations are better prepared; however, such research is challenging at many levels and it is critical to have an ethical framework that guides the research, places individuals and communites at the heart of the research and facilitates the maximum benefit for the maximum number of people improving vaccine trials in infectious disease emergencies progression of ebola therapeutics during the - outbreak ebola therapies: an unconventionally calculated risk performance of different clinical trial designs to evaluate treatments during an epidemic the one health concept: years old and a long road ahead surveillance of zoonotic infectious disease transmitted by small companion animals prioritizing zoonoses: a proposed one health tool for collaborative decision-making evaluation of the emergency prevention system (empres) programme in food chain crises report of the who/fao/oie joint consultation on emerging zoonotic diseases (who european centre for disease prevention and control. towards one health preparedness the economic and social burden of the ebola outbreak in west africa epidemics cause enormous disruption to countries, regions and the world; however, the focus is often on the epidemic itself, the pathogen and its immediate effect rather than the much broader effect that the epidemic has not only on the healthcare system-which lasts long after the epidemic itself-as routine vaccination programmes often collapse, maternal-child health suffers, and malaria, hiv and tuberculosis clinics and surgery-all aspects of healthcare-are disrupted, but also on the wider society, as mistrust and tension occurs between citizens, authorities and governments, and education, investments, businesses, trade and tourism inevitablely suffer leading to an economic impact that can health-care worker mortality and the legacy of the ebola epidemic patterns of demand for non-ebola health services during and after the ebola outbreak: panel survey evidence from further pieces of evidence in the zika virus and microcephaly puzzle responding to the ebola virus disease outbreak in dr congo: when will we learn from sierra leone? artificial intelligence in medical practice: the question to the answer? artificial intelligence and big data in public health structure of rsv fusion glycoprotein trimer bound to a prefusionspecific neutralizing antibody vaccine platforms: state of the field and looming challenges platform technologies for modern vaccine manufacturing four steps to precision public health precision" public health -between novelty and hype offline: in defence of precision public health mapping imported malaria in bangladesh using parasite genetic and human mobility data pregnant women & vaccines against emerging epidemic threats: ethics guidance for preparedness, research, and response increasing the participation of pregnant women in clinical trials the ethics working group on zikv research & pregnancy. pregnant women & the zika virus vaccine research agenda: ethics guidance on priorities, inclusion, and evidence generation acknowledgements we thank m. regnier at wellcome for editing the manuscript.author contributions all authors developed the scope and focus of the review and contributed to the writing of the manuscript. the authors declare no competing interests. correspondence and requests for materials should be addressed to j.f. reviewer information nature thanks peter byass, sharon peacock and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. reprints and permissions information is available at http://www.nature.com/reprints. publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -dvdx ggv authors: briggs, andrew m.; shiffman, jeremy; shawar, yusra ribhi; Åkesson, kristina; ali, nuzhat; woolf, anthony d. title: global health policy in the st century: challenges and opportunities to arrest the global disability burden from musculoskeletal health conditions date: - - journal: best pract res clin rheumatol doi: . /j.berh. . sha: doc_id: cord_uid: dvdx ggv the profound burden of disease associated with musculoskeletal health conditions is well established. despite the unequivocal disability burden and personal and societal consequences, relative to other non-communicable diseases (ncds), system-level responses for musculoskeletal conditions that are commensurate with their burden have been lacking nationally and globally. health policy priorities and responses in the st century have evolved significantly from the th century, with health systems now challenged by an increasing prevalence and impact of ncds and an unprecedented rate of global population ageing. further, health policy priorities are now strongly aligned to the sustainable development goals. with this background, what are the challenges and opportunities available to influence global health policy to support high-value care for musculoskeletal health conditions and persistent pain? this paper explores these issues by considering the current global health policy landscape, the role of global health networks, and progress and opportunities since the – bone and joint decade for health policy to support improved musculoskeletal health and high-value musculoskeletal health care. summary of system-level (macro) and organisation-level (meso) factors that influence msk health. adapted from briggs et al. [ ] and woolf et al. [ ] . health system level determinants of musculoskeletal health what could be changed to deliver sustainable, high-value care the macro level considers the functionality and scope of health systems, health policy, infrastructure and resource allocation, and socioeconomic factors. health systems and their governance through health policy play a critical role in the planning and delivery of msk health care. health care systems in developed nations are usually oriented towards acute care services and respond to mortality risk rather than longterm morbidity associated with msk conditions and their co-morbidities, which hinders opportunities for service development in ambulatory and primary care e arguably, the setting where msk health care is most needed. given that the msk conditions are less frequently associated with mortality, health systems and policy tend to be less responsive to these conditions and place lower importance on the development of policies and programmes to address them. this contributes to a general lack of population awareness concerning the burden and impact associated with msk conditions. further, access to msk health care is variable according to geography, ethnicity and socioeconomic status, creating unhelpful care disparities [ e ] . the impact of impaired msk health on function, mobility, quality of life, mental health and economic prosperity of the individual and their society should be communicated at a societal level e governments, employers, educators and to communities. the inaccurate perception that pain and disability are an inevitable part of ageing or due to tissue-level wear and tear' should be addressed. given that populations are ageing and becoming more obese and less active, the impacts on the msk system will be profound [ ] . primary prevention initiatives for chronic diseases should include messages about preventing impairments in the msk system. mass media campaigns for back pain, for example, are known to be effective in this regard [ e ] and potentially transferable to low and middle income settings [ ] . msk health should be explicitly included in polices and frameworks that address non-communicable diseases, chronic diseases or lifecourse and ageing [ , ] . developing system capacity (governance, resourcing, infrastructure) to support msk health care delivery in community or ambulatory care settings in urban and rural locations is important for health system sustainability. operationally, this is likely to be achieved by implementing evidence-based models of care at the community level [ , ] . encourage multidisciplinary stakeholders (including funders, insurers, policy makers, educators, consumers and carers) to co-design and co-implement models of care [ ] . meso the meso level considers health services, the volume and competencies of the clinical workforce, health professional and student/ trainee education, service delivery systems and clinical infrastructure. despite the identified burden of disease, the delivery of msk care from practitioners and health systems often inadequately aligns with best available evidence for what works [ e ]. this may be attributed, in part, to deficiencies in knowledge and skills of health professionals, but it is also largely influenced by funding and service models that inadequately support effective co-care. access to, and delivery of, care is further complicated by the chronicity of msk conditions and the high prevalence of comorbid conditions, particularly mental health conditions. development of knowledge and skills among health professionals to manage msk health conditions using a best practice, person-centred approach is required [ , ] to ensure that people receive the right treatment, at the right time, by the right person. as msk problems are so common, health professionals and community health workers at the first point of contact need approprite competencies (e.g. for osteoarthritis care [ ] ). in high-income countries, this is required amongst family physicians [ ] , and in low income countries by community health workers [ ] . professional bodies representing msk health should support curriculum development and delivery for junior health professionals. develop capacity of the non-medical health workforce to contribute to the management of msk health conditions in an interdisciplinary, inter-professional and non-hierarchical manner [ e ] . further, it is important, where feasible, to work towards achieving a this paper highlights why we need to address health policy to ensure that all health systems are fit for the purpose of providing high-value care for msk conditions and it covers health promotion, prevention, management, rehabilitation and palliation. we consider the current global health landscape, including opportunities and challenges for reform, and the role of global health networks. we also consider what has been achieved through the bone and joint decade and beyond. we also address the gaps and priorities in the context of influencing global health policy and health systems reform. [ , ] . undertake more health services research relating to the implementation of best practice models of care that incorporates program evaluation, health economic evaluation and consumer-centred outcomes [ , ] . encourage employers to support older employees with msk health conditions to maintain productive employment and promote safe workplaces. improve referral networks and pathways between providers, especially between those in primary and secondary care (e.g. between family physicians, hospital-and primary-care based allied health practitioners, rehabilitation services and medical specialists). the global health policy landscape: challenges and opportunities the global health policy landscape has evolved from the th century into the st century, reflecting dramatic changes in population health over this period. although the burden of disease associated with msk conditions has remained high over time, evidenced for example by low back pain being the leading cause of global disability since global burden of disease (gbd) study measurements commenced in [ ] , it was not prioritised as a global health priority in the th century. whereas priorities for the th century largely focussed on communicable diseases such as hiv, nutritional deficiency disorders, maternal and child health and injury and trauma associated with war, the issues impacting human health in the st century have evolved, creating new and complex challenges for health systems at all stages of maturity [ ] . health systems in the st century face new and complex challenges such as rapid population ageing, increasing disability attributed to non-communicable diseases (ncds) and multimorbidity of ncds, antimicrobial resistance, rapid transfer of pathogens through travel and migration that have the potential to create pandemics (e.g. coronavirus disease covid- pandemic), climate change and natural disasters [ , ] . for low and middle-income countries (lmics), these contemporary challenges are being experienced along with ongoing challenges of communicable diseases, thus creating an increased burden and complexity of challenges for these nations. the issues of ageing and behavioural determinants leading to increased morbidity from ncds are of particular relevance to msk health and are the focus of this paper. we acknowledge, however, that injury from falls, violence, war, workplace incidents and road trauma are highly relevant to msk health and the global burden of injury [ ] . population ageing is advancing at rates not previously seen in human history [ ] . this is particularly apparent in lmics due to reductions in mortality at younger ages and fewer deaths from infectious diseases. most older people now live in lmics and this distribution is expected to continue [ ] . life expectancy has increased in most countries (expectancy has risen by about years since ; from years in to years in [ ] ), with the age-standardised global mortality rate declining by % from to [ ] . the implications of extended longevity include unprecedented demand on health and social care services and the need to dramatically realign health systems to respond to changing health needs, which include the delivery of care over extended periods to manage long-term health conditions and the establishment of long-term care systems [ , ] . while some countries have made considerable advances in this area, such as japan and korea, much system reform is needed in many others, especially in lmics [ ] . it is estimated that by , the number of people aged and over globally will comprise about % of the world's population [ ] . with a total population estimate of . billion by (an increase of % from estimates), people aged over years will comprise more than . billion persons, or more than double the current number, with most living in lmics [ ] . the prevalence of age-related msk conditions will undoubtedly continue to rise placing increased demand on surgical, pharmaceutical and rehabilitative care interventions. systems and regulations to prioritise delivery of high-value msk care will become more imperative and urgent across the globe [ , ] . for high-income economies, overcoming unhelpful commercial influence over access to, and delivery of high-value msk care will be important [ ] . conversely, in lmics, building system capacity to deliver basic, effective msk pain care remains a priority [ ] . the e decade of healthy ageing is therefore a timely and appropriate opportunity to leverage global efforts to support healthy ageing and it explicitly includes msk health [ , ] . in this context, the optimisation of the msk system to maintain a person's intrinsic capacity will become increasingly important, creating opportunities to realign health systems to better support functional ability through improved prevention and management of msk conditions. this is evidenced by the fact that msk function and mobility are key components of the who integrated care for older people approach [ ] and are a focus of the who rehabilitation agenda [ , ] . health-adjusted life expectancy (hale), or healthy life expectancy', which quantifies years expected to live in good health, increased between and , although by a smaller magnitude than total life expectancydfrom years in to years in [ ] . the gap between life expectancy and hale points to a period of living in poorer health. notably, the gap has increased by a larger magnitude for people in lmics and is largely related to the burden of ncds. ncds account for the majority of the current total burden of disease (now %; an increase of % from to ) [ ] and the majority of the current total disability burden (now %; an increase of % from to ) [ ] . critically, the disability burden is largely attributed to msk pain conditions [ ] and persistent pain more generally [ ] . health system challenges are further exacerbated by a rise in ncd multimorbidity prevalence, commonly featuring msk pain conditions [ e ]. when considering msk pain as an index condition, up to % of adults aged e years have a concurrent chronic health condition [ ] . a prevalent msk health condition concurrent with other chronic conditions is associated with poorer health (higher ratings of pain, psychological distress and work interference) and significantly greater health costs (up to times higher) compared to those without multimorbidity [ , ] . multimorbidity with ageing is now the norm [ , ] , not the exception, suggesting that integrated care approaches that explicitly include msk health are essential, rather than the usual siloed, disease-specific care [ ] . there is a strong argument and opportunity, therefore, to strengthen health systems to respond to the increasing burden of ncds, particularly multimorbidity of ncds, and to integrate msk conditions within this agenda as an equal priority with other ncds [ , , , e ] . the sustainable development agenda: implications for global health policy global health system reform and health priorities for the next decade will largely be responsive to the agenda for sustainable development. this agenda is framed by the interdependent sustainable development goals (sdgs), providing a -year global blueprint ( e ) that aims to deliver a better and more sustainable future for all, including health. the sdgs replace the eight millennium development goals (mdgs) of e . three of the eight mdgs included a focus on health: child mortality (mdg ), maternal health (mdg ) and communicable diseases (mdg ). while the progress towards the targets for these health-related mdgs was encouraging, many fell short of targets [ ] . the health goal for the sustainable development agenda (sdg ) aims to "ensure healthy lives and promote well-being for all at all ages" and is intentionally linked with the other goals. indeed, a recent analysis confirmed the highly synergistic relationship between the sdgs, as illustrated in fig. [ ] . several of the other sdgs have direct relevance to supporting the health sdg (sdg ), and the health sdg synergistically supports the non-health sdgs [ , ] . brolan et al. [ ] highlight the importance of the non-health sdgs in promoting the social determinants of health such as nutrition (sdg ), education (sdg ), gender (sdg ), water and sanitation (sdg ), employment (sdg ), reducing inequalities (sdg ), housing (sdg ) and healthy environments (sdgs e ). they further highlight the importance of sdgs and to support health system strengthening through good governance and multi-stakeholder partnerships for health, strong data and information systems, and equitable access to quality health care services and associated entitlements. sdg (decent work and economic growth) aims to "achieve full and productive employment and decent work for all women and men, including for young people and persons with disabilities, and equal pay for work of equal value". a healthy population is a prerequisite for development and underpins economic growth [ ] . sdg is, therefore, particularly relevant to people with msk conditions in the context that msk conditions are the main contributor to loss of productive life years and the disability employment gap [ , ] . the health goal (sdg ) has targets, which include four implementation targets ( a- d; box ). the sdg targets present both challenges (to address) and opportunities (to lever) to improve msk health. target . , focusing on universal health coverage (uhc), is the unifying target for all the other health targets and arguably relevant to other sdgs [ ] . the who defines uhc as "all people and communities can use the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship" world health organisation, https://www. who.int/health_financing/universal_coverage_definition/en/. uhc is relevant to achieving msk health gains and provides an opportunity to do so, for example through providing access to important promotive and rehabilitative services and medicines that are relevant to msk health through essential packages of care. however, although sdg target . appropriately aims to reduce mortality attributed to ncds (predominantly cancer, diabetes, respiratory disease and cardiovascular disease), there remains an under-emphasis on reducing disability associated with ncds, despite unequivocal data highlighting the growing global burden of disability [ ] . the apparent mismatch between the target and global health estimates limits the opportunity to strengthen health systems in the area of greatest need; that is, to respond to the burden of disability which is largely attributed to msk conditions [ ] . considering the sustainable development agenda and evidence of global health trends, national governments and intergovernmental organisations are increasingly cognizant of the urgency to reform and realign health systems to respond to contemporary health challenges, particularly those in relation to ageing and ncds [ , ] . the historical approach to health care is no longer fit for the purpose, and health systems in many countries remain ill-equipped to manage trajectories for ncds and ageing [ , e ] . while there is absolutely a need for episodic and curative care for communicable diseases and responding to natural disasters and health emergencies (such as the covid- pandemic) and for tertiary hospitals to deal with complex case management and maintain standards of maternal and child health, a system that overemphasises episodic curative health care grounded in a biomedical approach cannot meet contemporary and evolving health needs [ , , ] . rather, what is needed is a strong primary health care system that is accessible through uhc that supports promotive, preventive, rehabilitative and palliative care through integrated care delivery and is bolstered by a long-term care system [ , ] . the box targets for sdg : ensure healthy lives and promote wellbeing for all at all ages' (reproduced from https://www.who.int/sdg/targets/en/). . by , reduce the global maternal mortality ratio to less than per live births. . by , end preventable deaths of newborns and children under years of age, with all countries aiming to reduce neonatal mortality to at least as low as per live births and under- mortality to at least as low as per live births. . by , end the epidemics of aids, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases. . by , reduce premature mortality from non-communicable diseases by one-third through prevention and treatment and promote mental health and well-being. . strengthen the prevention and treatment of substance abuse, including narcotic drug abuse and harmful use of alcohol. . by , halve the number of global deaths and injuries from road traffic accidents. . by , ensure universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes. . achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. . by , substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination. .a strengthen the implementation of the who framework convention on tobacco control in all countries, as appropriate. .b support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the doha declaration on the trips agreement and public health, which affirms the right of developing countries to use to the full the provisions in the agreement on trade-related aspects of intellectual property rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all. .c substantially increase health financing and the recruitment, development, training and retention of the health workforce in developing countries, especially in least developed countries and small island developing states. .d strengthen the capacity of all countries, particularly developing countries, for early warning, risk reduction and management of national and global health risks. necessary realignment of health systems to address these challenges presents opportunities to better address the burden of long-term and high-burden msk conditions. achieving system-wide reform demands both global cooperation and national effort in responsive health policy [ , ] . globally, the declaration of astana catalysed recommitment to the declaration of alma-ata to strengthen people-centred primary health care systems that are "high quality, safe, comprehensive, integrated, accessible, available, and affordable for everyone and everywhere" [ ] , consistent with the concept of uhc. the astana declaration is highly relevant to the contemporary health need, particularly in addressing multimorbidity from ncds and supporting healthy ageing [ , , ] , and is therefore relevant to optimising msk health. examples of other relevant global initiatives supporting system reform for ncds and ageing include the who integrated care for older people (icope) approach as a component of the global strategy and action plan on ageing and health [ ] , the who rehabilitation agenda [ ] and who best buys' for ncd prevention and control [ ] . all these initiatives offer direct and indirect opportunities to support msk health care. however, the horizon for improvement in msk health through national health policy for ncds remains challenging [ , ] . linked to sdg . , global performance and monitoring targets for ncds are principally aligned with mortality reduction for cancer, diabetes, respiratory conditions and cardiovascular disease, leaving less flexibility for prioritisation of msk health, thereby offering fewer opportunities for governments to support necessary reform efforts for msk health care [ ] . the who package of essential noncommunicable disease interventions for primary health care in low resource settings is also focussed on heart disease, stroke, cardiovascular risk, diabetes, cancer, asthma and chronic obstructive pulmonary disease [ ] and policy initiatives in lmics have historically overlooked msk health [ ] . in a recent systematic analysis of health policies focusing on integrated prevention or management of ndcs among member states of the organisation for economic co-operation and development, most countries had policies with targets for cancer ( %), cardiovascular disease ( %), diabetes ( %), respiratory disease ( %) and mental health ( %), while only % of countries had policies with an explicit focus on msk health and/or pain [ ] . nonetheless, many of the proposed activities across the policies were relevant to improving msk function, potentially offering opportunity for improvement. further, several nations are developing national and sub-national responses to the burden of msk conditions through the development of strategic frameworks and models of care [ , e ] . for example, the australian commonwealth government has commissioned national strategic action plans for a range of ncds, including arthritis, osteoporosis and pain management, and resourcing to support implementation of the actions plans has commenced [ e ] . other examples include a strategic framework for the prevention of msk health conditions across the life course by public health england (box ) [ ] and the ongoing development of a national pain strategy in canada. the ncd health policy and strategy landscape for lmics remains less clear. there are a number of contemporary whole-of-system opportunities to positively influence global health policy and improve msk health outcomes, including: consistent and unequivocal data on burden of disease for msk conditions [ ] . unsustainable health expenditure on msk conditions that eclipses other ncds (e.g. $usd . billion for msk health care in the us in ) [ ] and the costs of work loss and reduced productivity attributed to msk conditions [ ] , promotion of global initiatives that prioritise functional ability (e.g. icope [ ] ) evolution of national health policy and strategic action plans that prioritise msk conditions within the ncd area [ , e ] . recommendations from the who independent high-level commission on ncds that efforts to address premature mortality and disability attributed to ncds must be rapidly accelerated [ ] , and widespread promotion of initiatives to support delivery of high-value msk care, such as 'choosing wisely' [ ] . the global community (consumers, clinicians, researchers, policy makers and industry) concerned with msk conditions constitutes a global health networkda web of "individuals and organisations linked by a shared concern to address a condition that affects or potentially affects a sizeable portion of the world's population" (p. ) [ ] . over the past quarter century global health networks have proliferated and now exist for most major health conditions, including msk conditions (e.g. through the global alliance for musculoskeletal health (g-musc): https://gmusc.com/, and others). many, such as the global polio eradication initiative, are governed by formal institutions. others are characterised by informal ties, such as an emerging network concerned with the provision of surgical care in lmics [ ] . the global health network concerned with msk conditions is of this informal kind. differences in the effectiveness of global health networks may be one reason for the considerable variance that exists in the amount of attention and resources global health conditions receive. for example, hiv attracts considerable global attention, resources and priority in health policy and programs relative to msk conditions, despite the burden of disease of msk conditions being far higher. evidence concerning the global health network that addresses msk conditions suggests that it also faces challenges in each of these areas. an opportunity exists, therefore, to optimise the effectiveness of the global health network for msk health by considering and responding to each of these challenges. the first two challenges, problem definition and positioning, pertain to framing'. framing is a process of constructing meaning that enables individuals to organise experience, to simplify and make sense of the world around them, and to justify and facilitate collective action [ , ] . problem definition pertains to a challenge internal to the networkdhow members understand the problem and its solutions. problems and solutions can be conceptualised in many ways. for instance, those involved with population and reproductive health policy have disagreed on whether individual rights or social consequences provide the primary rationale for addressing these issues, and on the centrality of family planning provision in this agenda [ ] . in msk health and pain care, for example, there has been a historical lack of consensus about the classification of chronic primary pain as a condition in its own right, requiring a unique icd classification [ ] . a key challenge for global health networks is that they often become embroiled in conflict over problem specification and solutions, hampering their ability to act collectively. if problem definition is largely an internal framing matter, positioning is an external framing concerndhow the network portrays the issue to external audiences [ e ]. any given issue can be portrayed in multiple ways, and only some may resonate with the external actors whose resources are needed to make progress in addressing a problem. for example, hiv/aids has been portrayed as a public health problem, a development issue, a humanitarian crisis and a threat to security [ ] . some positionings resonate more than others, and different positionings appeal to different audiences. a key positioning challenge for msk health is that most msk conditions are chronic and impact function, while other ncds are more closely associated with mortality than morbidity. there is also a public perception that msk health conditions are an inevitable consequence of ageing. finance ministers, for instance, might be more likely to respond to portrayals that emphasise the economic costs of a health problem than health ministers, who might pay more attention to ones that focus on public health benefits, losses and mortality. the external positionings networks usually mirror the problem definitions they create. coalition-building pertains to the recruitment of allies beyond core proponents. many global health networks are insular; they consist largely of individuals and organisations within the health sector and with a specific focus on the issue. research indicates that those networks that build coalitions that reach beyond like-minded actors and that extend beyond the health sectorda task that necessitates engagement in the politics of the issue, not just its technical dimensionsdare more likely to achieve their objectives [ ] . since msk health is highly relevant beyond ageing and co-morbidity of ncds, creating stronger alliances in areas of education, work health and safety, child and adolescent health, road traffic injury and trauma, building and infrastructure and sports may be effective in coalitionbuilding and increasing global attention. governance pertains to the establishment of institutions to facilitate collective action. provan and kenis [ ] identify three primary modes of network governance: . shared: where most or all network members interact on a relatively equal basis to make decisions; . lead organisation: where all major network-level activities and key decisions are coordinated through and by a single participating member; and . network administrative organisation: where a separate entity is set up specifically to govern the network and its activities. it is not that one mode is better than others; the question is whether the mode is congruent with characteristics of the network. for instance, a small network whose members trust one another and agree upon goals may be destroyed if a single individual or organisation with a particular agenda comes to dominate it. a large network whose members lack trust in one another and who disagree on goals may need a lead organisation to bring about effective collective action [ ] . what has been achieved from the bone and joint decade and where are the gaps in influencing global health policy and system reform? positively influencing global health policy and system reform requires attention to the challenges of problem definition, positioning, coalition-building and governance. how well the msk health community address these challenges will likely shape its capacity to generate attention and resources for msk conditions during the sdg agenda and beyond. here, we reflect on how these challenges resonate with the global msk health community, actions that have been taken to date in addressing these challenges and future priorities to enable positive global action on msk health. in , clinicians, researchers and patients from a spectrum of international and national organisations that were all relevant to msk health came together in recognition of the lack of priority for msk health and msk science to consider how this could be collectively changed [ ] . the following priorities were identified: raise awareness of the impact of msk disorders; enable patients to more effectively participate in their own care, provide accessible cost-effective prevention and treatment, and increase knowledge through research. the vision for improving msk health globally was consistent with ensuring high-value evidencebased accessible uhc for people with, or at risk of, msk conditions. broad adoption of this internal framing by the global msk health community was required, although a range of challenges existed and continue to be relevant. historically, a challenge has been how to define the problem of msk health impairment and possible solutions in a way that the whole msk health community, or global network, understands and supports the need for collective action at a global scale. the first challenge is to agree on what are msk conditions. there is a wide range of problems that affect the msk system including sprains and strains; traumatic injuries; osteoporosis and fragility fractures; back pain and other regional or generalised pain problems; osteoarthritis; and inflammatory diseases of joints and other msk structures such as rheumatoid arthritis, ankylosing spondylitis, gout, and systemic lupus erythematosus. this broad suite of more than conditions makes defining msk health challenging and msk health may mean different things to different groups. the second challenge is that, despite the commonality between these conditions in the resultant pain and impact on physical function, there are wide differences in which professionals manage them. this varies by the stage of the care pathway and by differences in health systems. for example, inflammatory conditions are usually managed by rheumatologists; trauma and advanced structural deformity by orthopaedic surgeons; regional pain problems by physiotherapists, chiropractors and pain medicine specialists; and osteoporosis by a wide range of specialties; and most interface with family physicians. in lmics, workforce configurations differ according to setting. although the management of these conditions is ideally through integrated care pathways, there is commonly a lack of integrated working between the different professional groups and health care settings and a lack of understanding of each other's capabilities in interprofessional care. there is also often competition between different professions in some health systems where there is an activity-based or fee for service funding model, which may not encourage high-value care interventions [ ] . the third challenge is harnessing a global network to influence global policy and drive reform. stakeholders do not always recognise the importance and power of collective action at the global policy level. they may not appreciate how collective action is relevant to their context, which is usually at a local or national level and often specific to their professional or patient community. the bone and joint decade e initiative focused on collective action at the global and national levels [ ] . a who scientific group meeting was held concurrent to the launch of the decade to define the global impact of msk conditions, collating data from all global regions [ ] . the decade intentionally enabled organisations from international and national clinical, research and patient communities to come together and work as an alliance to deliver the shared goals of the decade. champions were identified within the different stakeholder groups and nationally to develop the collective approach. a person-focused appraoch provided a unifying goal for the stakeholders to encourage joint action and was facilitated at the local level through national action networks. through sharing experiences, opportunities for global action could be addressed by the msk global network. it was recognised that the lack of priority and policies related to msk health was due to absence of awareness among policy makers, non-expert health workers and public about: the impact of msk conditions (epidemiology, costs, etc.); what can be achieved through prevention and treatment; and how to implement evidence to optimise prevention and management of msk conditions. to provide this evidence and to support advocacy, the bone and joint monitor project was initiated as a flagship initiative of the decade [ ] . the project focused on identifying the burden of disease by working with the who and the gbd study group. concurrently, it considered what could be achieved through the implementation of current evidence, what was being achieved, where were the gaps and how can they could be closed (fig. ) . all activities to provide the evidence for advocacy were undertaken in a collaborative way, bringing together experts and organisations from the wider msk health community so there was a shared understanding of the problems and solutions and a common narrative. the work stream is ongoing. a major step in promoting global attention to msk health was recognising at the start of the decade that the burden of msk disorders on individuals and society needed to be better characterised and communicated. critical promotion was achieved through collaboration with the who and the gbd study and working with experts in all diseases across the globe. to ensure wide relevance, this has included all disorders that can affect msk health. from a conviction of the unrecognised burden, this coalition has provided independent evidence that msk conditions are the greatest cause of disability in most parts of the world, which is influencing priorities at the policy level [ ] . this theme of work has continued since the decade concluded in through a range of global initiatives in addition to the ongoing activities of g-musc; for example through the lancet series on low back pain [ ] , dedicated reports on msk burden of disease [ , e , ] and advocacy initiatives from international organisations such as the fragility fracture network [ ] , international osteoporosis foundation [ ] and the international association for the study of pain. . evolve a robust and consistent web of evidence concerning the costs to society from msk health conditions in terms of health and social care and lost productivity. while summative health estimates are important to measure relative disease burden and set priorities, measuring and communicating the economic impact is necessary to achieve greater investment in msk health. msk conditions are amongst the greatest causes of work loss through absenteeism and presenteeism as most work-related activities are dependent on good msk function. with ageing populations and extended working lives in many countries, these costs will grow significantly unless more is done to prevent and control msk conditions. the increasing magnitude of cost related to lost productivity has resulted in greater priority for msk health in countries where the state bears a large part of the cost of people unable to work, such as in the united kingdom (uk) where policies are being developed to address this [ ] . . address misconceptions about msk health. the barriers to prioritising msk health are the inaccurate concepts that msk conditions are inevitable consequences of ageing or of certain occupations and that little can be done to prevent or treat them. communicating evidence about high-value interventions that health systems and services can implement, including disinvestment in care that is ineffective remains important. an early project of the bone and joint decade was the european action towards better musculoskeletal health' [ ] . this project developed a common policy to prevent and control a spectrum of msk conditions, reviewing the evidence base and identifying what actions the public, people with msk conditions, clinicians and policy makers could take. simple messages were developed for the whole population, for those at risk, for those with early disease and for those with established conditions. these messages were elaborated with more specific recommendations for the different msk conditions to meet all stakeholders' needs. costeffective health interventions for msk conditions were also developed for lmics as part of the disease control priorities in developing countries' report e an initiative of the world bank, who and national institutes of health [ ] . . support health systems to deliver high value care. an ongoing challenge is that guidelines and recommendations often do not get implemented in practice. the "european action towards better musculoskeletal health" project suggested ways to improve implementation. models of care for msk conditions have and continue to influence health system governance and service delivery for msk conditions [ , ] and a framework to support development, implementation and evaluation of models of care has been created and globally supported [ ] . standards of care for various msk conditions have also been developed to support consistent delivery of high-value care [ e ]. national strategies have been developed to prioritise msk health, most recently in australia [ e ] and england [ ] . box provides an overview of the approach taken by public health england in this regard. the approach of the bone and joint decade and subsequently of g-musc in supporting collective and incremental action has enabled the msk health community to define the problem and identify jointly agreed solutions, with efforts and outcomes focused mainly at the micro and meso levels. the emergence and acceptance of models of care have been instrumental in influencing reform at the system level. a continued effort towards influencing policy makers at the national and global levels through health system strengthening approaches is essential [ , ] . positioning the case (external framing) and coalition building to influence policy makers, there is a need for them to be empathetic to the importance of msk health through evidence or personal experience. there is also a need to identify what issues are relevant and important to them and how prioritising msk health will enable them to achieve their goals, such as reducing work absenteeism or increasing physical activity. supporting policy makers to explicitly integrate msk health into policies for ncds more generally remains an important priority [ ] . to further strengthen the case for action, there is a need to identify, engage and develop partnerships with stakeholders/alliances external to health where there is a potential benefit of improving msk outcomes, such as manufacturing, construction, logistics and other sectors where msk function is essential for people to remain in work. action on external framing has been pursued since the launch of the decade and increasingly since the transition of the decade to g-musc, with a range of successful cross-sectoral partnerships established. while health policy makers are the obvious primary external stakeholders to influence, there are competing priorities with health conditions which have a higher mortality burden, are part of the growing burden of diseases associated with unhealthy lifestyles, such as diabetes and heart disease, or which garner a lot of public support, such as mental health and dementia. the necessary attention to, and resourcing for the covid- pandemic will undoubtedly have an impact on health services for people with msk conditions. the evidence of the burden of msk conditions supported by evidencebased policies that support high-value care which will prevent msk problems has gained traction. developing a whole system collaborative and partnership to prevent musculoskeletal health conditions and improve musculoskeletal health across the life course in england. this case study summarises the experience in england of developing and implementing a public health approach to the prevention of and intervention in, msk conditions across the life course. it highlights key elements of the approach, the essential role of galvanising and supporting partnerships, achievements and future aspirations. a more detailed commentary has been published previously [ ] . england, like many other countries, does not have a specific government policy purely focussed on msk health, despite msk conditions imposing the greatest burden of disease, with lower back and neck pain the leading causes of disability in england from to [ ] . the estimated msk prevalence of chronic back pain in adults in / was . % [ ] . a systematic review of the prevalence of chronic pain in the uk indicates a pooled prevalence of % (the majority of which is likely from msk aetiology), with evidence of an increasing prevalence over time [ ] . msk conditions are costly for the uk health services, with over % of the uk population consulting their general practitioner about an msk condition each year and the national health service (nhs) spending an estimated £ billion each year on treating them [ ] . further, approximately . million working days were lost in as a result of an msk condition [ ] . in the last couple of years, there has been a recognition of the importance of maintaining good msk health in work and health policy e prevention green paper-advancing our health [ ] , the nhs year long term plan [ ] , government's ageing society grand challenge [ ] and the development of public health england's year msk strategic framework [ ] . driving system change for msk health: lessons from england's experience a whole system approach that starts with the development of robust partnerships and collaborations to deliver a shared vision for population health is essential. public health england provided system leadership, bringing together a coalition of willing and committed stakeholders from across national and local governments, the nhs, third sector, professional bodies, and arthritis and musculoskeletal alliance to "improve the musculoskeletal health of the population in england across the life-course, supporting people to live with good lifelong msk health and freedom from pain and disability" [ ] . partnerships inevitably bring with them new and diverse capability, capacity and additional resources to support the vision to be realised. this is sustained through continuous joint prioritisation, candid conversations and monitoring of impact. after a gradual build-up of five years of activity based on incremental action, in the uk government published a number of documents that supported the case for increased attention to the msk health of the population: -the green paper advancing our health: prevention in the s' [ ] , which offers the next opportunity to further galvanise a shift of focus from cure to prevention. -health is everyone's business: proposals to reduce ill health-related job loss [ ] . system-wide implementation of osteoarthritis care programmes and secondary fracture prevention are notable examples [ , ] . the policy agenda in global health may differ from national priorities and this needs to be monitored and influenced to arrive at a consistent approach in external framing. the msk health community, largely through the bone and joint decade and subsequently g-musc, has positioned msk health in the global agenda of ageing, pain management, rehabilitation, road safety and care of the injured, interprofessional care, workplace health, workforce development and other areas where there is a recognised problem that the msk health community can help solve. the relevance of addressing msk health is not often spontaneously recognised by policy makers and the non-msk clinical community but these opportunities have been proactively identified and the case framed to show relevance. for example, g-musc has worked with the who on the who strategy for noncommunicable diseases; who europe action plan for ncds; the who decade of action for road safety; who global alliance for the care of the injured; who partners working in disability and rehabilitation; who global disability action plan e ; who icd revision through msk topic advisory group; who world report on ageing and health; who global strategy and action plan on ageing and health including the who integrated care of older people approach, and the who rehabilitation agenda. -the nhs year plan, which makes reference to workforce capability to implement frontline msk support, the scaling up of evidence-based interventions, such as escape pain, and digital platforms to deliver information to patients [ ] . -ageing society grand challenge, with a mission to "ensure that people can enjoy at least extra healthy, independent years of life by " [ ] . taken together with the secretary of state's prevention vision [ ] , prevention of msk conditions and other ncds is now seen as everyone's responsibility. integration with other health improvement policy areas major amenable risk factors of msk conditions are shared with many other ncds and therefore, public health england has taken the approach of embedding msk health in its work across multiple teams, such as the mental health, obesity, life course, inequalities, physical activity, healthy places, work and health. data and surveillance must be used to understand msk conditions in the population, monitor them over time and continuously drive improvement in health for people with msk conditions. public health england works in partnership with versus arthritis and other organisations to increase the quality and availability of data concerning msk conditions and the health and care services needed to address them [ ] . the year strategic msk prevention framework [ ] , along with plans to design a holistic adult health check in [ ] that may incorporate a functional capability element, followed up with tailored lifestyle advice and interventions will support population msk health in england. on the horizon are innovative ways of providing personalised care and health interventions using artificial intelligence and wearable devices. care. phe provides government local government, the nhs, parliament, industry and the public with evidence-based, professional, scientific expertise and support. phe exists to protect and improve the nation's health and wellbeing and reduce health inequalities. . articulate evidence-based arguments that clearly demonstrate how attention to msk health can achieve objectives of increasing healthy life years and control of other ncds through enabling mobility and physical activity. here, building coalitions with other disease groups will be essential. . shift global health targets to also address morbidity. the who approach to prevention and management of ncds prioritises those conditions associated with high mortality and common risk factors, consistent with sdg [ ] . this is not intended to de-prioritise other ncds, such as msk health, but in reality member states will respond to the given priorities and do not therefore engage the wider community, leaving out the importance of msk health from their discussions and plans. the priority of mental health, for example, often inadequately considers the bidirectional association between msk pain and mental health, leading to non-integrated solutions. . develop economic arguments for health to be seen as an investment into a productive workforce and a healthy independent ageing population. finance and employment ministries need to be aware of the costs of poor msk health and the return on investment of optimising it. this framing of the case has supported making msk health a priority in england (box ). addressing the challenge a current challenge is to know how best to work together as an msk health community, so we can take full advantage of the current and emerging opportunities to influence global and national health policy. policy makers prefer a consistent message, and the msk health community needs a way of developing and communicating a collective position that is supported by robust evidence. however, the implementation of such positions will most likely mean different things for the different stakeholders. there needs to be clarity as to: what is best done by g-musc; what is best done by individual stakeholders with the support of other stakeholders through g-musc, and what is done by single stakeholder groups with an awareness by others. the bone and joint decade e initiative subsequently g-musc has brought together champions for change from the msk health community who have led the campaign for msk health as a global priority, identifying opportunities and co-ordinating responses, working as committed individuals not formally representing organisations but coming from the wide spectrum of msk stakeholders and understanding issues of high, middle-and low-income countries. importantly, the programme of activities has been undertaken collaboratively with the wider msk health community, with the key partners being national networks and the major professional, scientific and patient organisations to ensure a person-centred and interprofessional approach. . now that the burden of disease and importance of msk health is clearly recognised, with many national and sub-national governments developing action plans, it is timely to consider changing the way the global campaign and global msk network is governed. . the global msk health community needs to decide its future and governance model to work collaboratively. different governance models have been described above and the power of social media to connect individuals, organisations and networks should be leveraged. the burden of disease of msk health is well established and likely to increase, along with other ncds. health policy is a critical component of health system strengthening to respond to the burden of msk diseases and persistent pain. the priorities for health systems in the st century have evolved from the th century, particularly in the context of challenges associated with ageing and ncds and also, currently, the covid pandemic. in this context, there are opportunities and challenges to optimise global and national health policy responses to address msk health and persistent pain and improve outcomes for people at risk of or living with msk health impairment. the sustainable development agenda represents an important contextual backdrop to health policy evolution in the next decade and this must be considered in the advocacy for msk health. unified and collective action from the global msk network will be important in influencing system-level change at scale. reflecting on the successes of other global networks, the achievements of the e bone and joint decade and unfinished business from that period should also help to inform the priorities, actions and governance of the global msk health community in the next decade. recommended foci for research practice and policy are outlined in box . with the necessary and dramatic shift of health priorities and resources to acute health care in the context of the covid- global pandemic, the msk health community needs to ensure it is well placed to i) argue the case for the importance of msk health for economic recovery (external framing); and ii) develop policies and service strategies to ensure people with msk health conditions can access care in circumstances where services are no longer provided due to the pandemic and post-pandemic. continued efforts to influence global health policy are needed in order to improve service delivery for msk health care, particularly in lmics. health policy foci around ageing and prevention and management of ncds present opportunities to positively influence msk health care. in particular, msk health should form a component of essential care packages in uhc arrangements [ ] . communicating the relevance and importance of msk health to global health policy and system reform efforts, such as the declaration of astana, rehabilitation and subsequent iterations of the who global action plan for the prevention and control of noncommunicable diseases, will be important. integrated care approaches for ncds should explicitly include optimisation of msk health, particularly in the context of multimorbidity. as national health policies evolve in response to changing health needs, particularly for ncds, msk health should be explicitly included as an equal priority with other ncds and in the context of multimorbidity and integrated care pathways [ ] . global health targets must evolve beyond just mortality reduction from specific ncds to also include arresting the trajectory of global disability, largely attributed to msk health and persistent pain conditions. harnessing the potential of the global msk health network by effectively confronting problem definition, positioning, coalition-building and governance will enable positive action in global health policy for msk health. continued efforts to measure the economic impacts of msk health impairment on health systems (e.g. proportion of health expendutire) and society (e.g. work productivity) remain important while msk clinical trials networks have a critical role in establishing evidence for interventions and implementation feasibility. health policy and systems research similarly has a critical role in continually evaluating options 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prevention in the s e consultation document. london: department of health and social care the nhs long term plan. london: nhs policy paper. the grand challenges. london: department for business, energy and industrial strategy department for work and pensions and department of health and social care. health is everyone's business: proposals to reduce ill health-related job loss: london coordinator-based systems for secondary prevention in fragility fracture patients generation of political priority for global health initiatives: a framework and case study of maternal mortality flipping the pain care model: a sociopsychobiological approach to high-value chronic pain care development of a core capability framework for qualified health professionals to optimise care for people with osteoarthritis: an oarsi initiative global low back pain prevalence and years lived with disability from to : estimates from the global burden of disease study no external funding was acquired to support this work. the authors declare no conflicts of interest. key: cord- -vob bu c authors: tam, theresa w.s; sciberras, jillian e; tamblyn, susan e; king, arlene; robert, yves title: the canadian pandemic influenza plan: an evolution to the approach for national communicable disease emergencies date: - - journal: international congress series doi: . /j.ics. . . sha: doc_id: cord_uid: vob bu c abstract advance planning for a large-scale and widespread health emergency is required to optimize health care delivery during an influenza pandemic. the canadian pandemic influenza plan (cpip) is an example of a successful communicable disease emergency plan that ensures a national, coordinated approach to preparedness, response and recovery activities in the event of an influenza pandemic. the general concepts incorporated into the cpip may be utilised in the contingency planning for a bioterrorism event or other communicable disease emergencies, including: a national, coordinated approach in planning; an emergency management structure to conduct the response; the use of common terminology to facilitate communication and response coordination, and the establishment of specific technical, communications and operational response groups and networks in advance. the multinational outbreak of severe acute respiratory syndrome (sars) in offered the opportunity for the testing of these concepts. the experiences and lessons learnt during the sars response may be utilised to strengthen communicable disease preparedness and response capacity. a future global epidemic or pandemic of influenza is highly likely if not inevitable, but is unpredictable in timing. when a novel influenza virus that is capable of efficient humanto-human transmission and causing high morbidity and mortality emerges, countries will have very little time to carry out the many key activities required to minimise the health, societal and economic impact of a pandemic. with the increasing recognition of the threat posed by the next influenza pandemic internationally, there is an accelerated effort by the world health organization (who) and many countries to develop or strengthen existing pandemic preparedness plans. [ , ] the world is still inadequately prepared for the next pandemic, however, ongoing efforts in preparedness activities and testing of the pandemic plans will continue to strengthen our response networks, processes and infrastructures. at the inception of the canadian pandemic influenza plan (cpip) in , the main focus was on a vaccine strategy. after the hong kong influenza a/h n incident in , the pandemic plan evolved to include a more comprehensive approach, incorporating the following key components: surveillance, vaccine programs, and use of antivirals, health services, emergency services, public health measures and communications. one of the main challenges of pandemic preparedness was to establish the essential close linkages between public health, health care and emergency response sectors. after the terrorist attacks of september , and the subsequent anthrax attacks in the united states, national authorities became acutely aware of the need to strengthen public health infrastructure to respond to health emergencies. in addition to the national pandemic influenza committee (pic), which provides technical advice on influenza pandemics, a national network for health emergency communications and a national forum which integrates public health and emergency measures were formed. the cpip evolved to include three main sections: ( ) preparedness, ( ) response and ( ) recovery, to be consistent with the general principles of emergency response and with the phased approach of the world health organization (who) framework. the general concepts incorporated into the cpip that may be utilised in the contingency planning for other infectious disease emergencies include: a national, coordinated approach to planning; an emergency management structure to coordinate and conduct the response; the need for common terminology (e.g. using the same response phases), and the need to have specific technical, communications and operational response groups and networks formed in advance. the recent national response to an influenza a/h n alert and a multinational outbreak of severe acute respiratory syndrome (sars) offered the opportunity for the testing of these concepts. on february , when the who confirmed a report of two cases of influenza a(h n ) associated with one death in the hong kong special administrative region, health canada activated the pandemic influenza committee and alerted the national surveillance system, ''fluwatch.'' the newly formed national health emergency communication network was also activated and fact sheets on influenza h n were developed. within hours after the first who global alert for atypical pneumonia on march , , health canada received reports of the first cases of sars in canada from provinces that were already on the alert for h n . the pandemic influenza response structures and processes were rapidly and successfully translated to respond to sars. pic was expanded to form the national sars technical advisory group. existing national technical groups (e.g. the canadian public health laboratory network) and pandemic influenza working groups were transformed into sars working groups, with links to the who sars laboratory, clinical and epidemiology networks. although the public health measures for limiting the impact of an influenza pandemic may be different from that for the containment of sars, we are now able to learn from the sars experience the types of measures that have been effective, feasible and acceptable to the public and health care providers. in canada, sars highlighted the deficiencies in the public health infrastructure, policies, procedures and legislation to support urgent public health action. sars reminded us of the need for a clear command structure with dedicated team leadership during a health emergency. health organizations are generally not set up with the command and control structures necessary to respond effectively to a large-scale emergency. jurisdictions that did not have well-developed pandemic influenza plans had to create structures immediately to deal with sars. the province of ontario, with the most involvement with sars, was not able to participate on an ongoing basis in national level technical discussions as all of its experts were contributing to the front line response. a national, technical planning group with members who are able to dedicate their time would be important in future responses. although federal, provincial and territorial public health departments are able to communicate alerts for emerging infectious diseases very effectively through telephone or e-mail systems, there is a need to enhance the delivery of information in a timely manner to front-line health and emergency workers. real time data sharing between hospitals and public health and between different levels of the public health system was a particular challenge, as was timely epidemiological analysis. the development of integrated mechanisms and processes for hospital-and community-based surveillance is required, including the strengthening of hospital surveillance capacity. pre-established data elements and data sharing agreements between local, national and international governments/organisations for emerging infectious diseases will facilitate the determination of key epidemiological parameters at the time of the emergency. the national case definitions designed for monitoring the spread and impact of sars were utilised inappropriately in some situations, e.g. for clinical management. although public health and infection control measures were implemented immediately and effectively, the classification and reporting of cases were delayed as retrospective epidemiological linkage of cases were made. case definitions should be developed and the rationale for any changes to case definitions should be clearly documented. there should be a consistent use of national case definitions and we should strive for international consistency where possible to facilitate international surveillance and communications. there was an unprecedented rapid generation of knowledge on sars through the existing influenza networks and new partnerships. the public health and research laboratories within canada made an immediate and valuable contribution to the international effort of elucidating the etiology of sars, the genetic sequencing of the sars-associated corona virus and the development of new diagnostic tests. however, especially at the provincial laboratory level, the inability to limit testing and to link laboratory data with epidemiological and clinical data resulted in over-testing and the inability to prioritise specimens. the public health measures instituted during sars were effective in containing the epidemic; however, the effectiveness of specific strategies is still being assessed. quarantine and isolation were generally acceptable to the public. cancellation of public gatherings will happen regardless of public health recommendations. in order to implement communitybased public health measures and institution-based infection control measures, the involvement of multiple partners is needed, including key health professional groups, non-governmental organizations, the media, businesses and schools. issues pertaining to international borders, such as travel advice, screening, quarantine and embargo of supplies, arise quickly and must be an integral part of emergency plans. blood safety and supply issues will also arise quickly at the start of any emerging infectious disease emergency. all jurisdictions need to strengthen human resource planning and surge capacity in their health emergency plans. there is a need to enhance our ability to mobilise resources across the country for outbreak investigation and control and to support health care services, including infection control. the sars response highlighted the need for more trained infection control personnel. the focus of hospital infection control resources on the containment of sars may have negative impacts, such as an increase in other nosocomial infections and failure to recognise or report other infections, e.g. tuberculosis. ongoing training of health care workers on the correct method of putting on and removing personal protective equipment is required before and during an epidemic. the negative impact of stringent infection control and other hospital policies on the wellbeing of health care workers, as well as the impact of work exhaustion and post-traumatic stress on responders, must be addressed in emergency plans. since sars was primarily a nosocomial disease in canada, managing hospital triage and patient transfer was essential to the local response. the experience gained in patient triage and in setting up dedicated clinics and other alternate care sites (e.g. screening units established outside hospitals) during the sars response is valuable for pandemic influenza preparedness. the feasibility and effectiveness of using specific hospitals or units within hospitals dedicated to the assessment and management of an emerging infectious disease should be assessed. establishing the security of medical and other supplies, e.g. through stockpiling and multiple suppliers, should be an integral part of logistics planning for health emergencies. preparedness for an influenza pandemic in canada currently includes the security of vaccine supplies and options for stockpiling antiviral drugs. communicating the progress and impact of an epidemic in real time to decision makers and the public is very challenging. considerable resources are required to translate scientific data (especially epidemiological data) into public information. in canada, information on health events is communicated openly and rapidly to the public, experts and health care providers to the media; therefore, public health spokespersons must be proactive in providing the correct information expediently to the public. the first phases of the canadian pandemic influenza plan have been tested and applied to another emerging infectious disease emergency. the plan requires ongoing review and evaluation through emergency exercises and the incorporation of lessons learnt from sars. common approaches to communicable disease emergency plans, with an emphasis on the strengthening of public health infrastructure and infection control in health care facilities, will be the key to future response to emerging infections. world health organization, global agenda on influenza surveillance and control influenza pandemic planning key: cord- -iv al l authors: dow, alan w.; dipiro, joseph t.; giddens, jean; buckley, peter; santen, sally a. title: emerging from the covid crisis with a stronger health care workforce date: - - journal: acad med doi: . /acm. sha: doc_id: cord_uid: iv al l the covid- pandemic has highlighted the limitations of the current health care workforce. as health care workers across the globe have been overwhelmed by the crisis, oversight entities and training programs have sought to loosen regulations to support ongoing care. notably, however, workforce challenges preceded the current crisis. now may be the time to address these underlying workforce challenges and emerge from the covid- pandemic with a stronger health care workforce. building upon historical exemplars in the context of the current crisis, the authors of this perspective provide a roadmap to rapidly and safely increase the workforce for covid- and beyond. the authors recommend the following: ( ) a comprehensive approach to guide health care workforce development, ( ) streamlining transitions to the next level of practice, ( ) reciprocity among state licensing boards or national licensure, ( ) payment reform to support a strengthened health care workforce, and ( ) efforts by employers to ensure the ongoing safety and competence of the bolstered workforce. these steps require urgent collaboration among stakeholders commensurate with the acuity of the pandemic. implemented together, these actions could address not only the novel challenges presented by covid but also the underlying inadequacies of the health care workforce that must be remedied to create a healthier society. a crisis-including the covid- pandemic-should never be wasted. the covid- pandemic presents a disruptive challenge to the health care system, and the u.s. medical community should embrace the opportunity to transform the health care workforce to better meet the needs of society in the future. covid- has overwhelmed health care workers in localities across the globe physically, emotionally, and ethically. accreditors, health professions schools, postgraduate training programs, governmental entities, and health systems have all taken steps to rapidly bolster the capacity of the health care workforce. these actions demonstrate that stakeholders in the u.s. health professions have the ability to adapt quickly to ensure the adequacy of the health care workforce. yet, even preceding the current crisis, many people in the united states received suboptimal care-in part due to limitations in the workforce. [ ] [ ] [ ] worse outcomes in certain communities exemplify these inequities. now is the time to examine the training and oversight of the health care workforce so that the united states can emerge from the covid- crisis with the practitioners its communities deserve. prior events illustrate how the health care workforce can adapt in crisis. during world war ii, health care professions altered the timing and content of their training. for example, medical schools shortened the time required to complete a medical degree, and many enrolled and graduated students at nontraditional times. shortages of health care personnel during the vietnam war led to the creation of a new profession, physician assistants, who rose from the ranks of trained navy medics. the federal government also developed a parallel draft system for licensed health care workers (the "doctors' draft") to ensure the adequacy of the military health care workforce. this process, the health care personnel delivery system, was codified into the federal regulations in but has yet to be invoked. in addition, various natural disasters (e.g., hurricanes katrina and maria) have led to the temporary suspension of state licensure regulations to increase the local pool of health care workers. while the timelines and scopes of these events differ from covid- , they demonstrate the capacity to reconsider the training, licensure, professional scope, and allocation of health care practitioners during crisis. during the covid- pandemic, several entities have adapted to expand the health care workforce. the liaison committee on medical education (lcme) has announced a process for early graduation of fourth-year medical students with approval of their schools. early work in competency-based medical education supports this approach as ethical, and some institutions have seized this opportunity to allow fourth-year students to begin internships early. at the graduate medical education (gme) level, the accreditation council for graduate medical education (acgme) has defined "three stages of gme during the covid- pandemic," which relaxes some regulations while ensuring the wellbeing of house staff. (notably, the three stages do not address early completion of training.) each of these changes in medical education have sought to increase the health care workforce while maintaining the quality of care. in nursing, some state licensure boards have waived clinical requirements for nursing education programs and have allowed simulation to replace direct patient care; both of these adjustments build on work by the american association of colleges of nursing (aacn) to develop competency-based, time-variable the covid- pandemic has highlighted the limitations of the current health care workforce. as health care workers across the globe have been overwhelmed by the crisis, oversight entities and training programs have sought to loosen regulations to support ongoing care. notably, however, workforce challenges preceded the current crisis. now may be the time to address these underlying workforce challenges and emerge from the covid- pandemic with a stronger health care workforce. building upon historical exemplars in the context of the current crisis, the authors of this perspective provide a roadmap to rapidly and safely increase the workforce for covid- and beyond. the authors recommend the following: ( ) a comprehensive approach to guide health care workforce development, ( ) streamlining transitions to the next level of practice, ( ) reciprocity among state licensing boards or national licensure, ( ) payment reform to support a strengthened health care workforce, and ( ) efforts by employers to ensure the ongoing safety and competence of the bolstered workforce. these steps require urgent collaboration among stakeholders commensurate with the acuity of the pandemic. implemented together, these actions could address not only the novel challenges presented by covid but also the underlying inadequacies of the health care workforce that must be remedied to create a healthier society. education. similarly, pharmacy schools have worked closely with state licensing boards and the national accreditation agency to enhance flexibility for clinical training. while these efforts are important first steps, expanding the health care workforce to address both the covid- crisis and the challenges that preceded it requires strategic coordination across health systems, licensing boards, accreditors, and entities (e.g., the centers for medicare and medicaid services [cms]) that pay for training. over the next several months, covid- may flare heterogeneously, and the workforce needs to be adaptable. the ideal response must be interprofessional and longitudinal. moreover, changes are necessary to ensure the adequacy of the workforce long term. in this perspective, we briefly outline recommendations that would address the underlying inequities in the current u.s. system and help prepare for future crises: ( ) a comprehensive approach to guide health care workforce development, ( ) streamlining transitions to the next level of practice, ( ) reciprocity among state licensing boards or national licensure, ( ) payment reform to support a strengthened health care workforce, and ( ) efforts by employers to ensure the ongoing safety and competence of the bolstered workforce. the united states needs a comprehensive approach to guide the health care workforce. the national health care workforce commission, established by the affordable care act but never funded by congress, might serve as a model. the commission was created to study the workforce and advise the federal government on trends, anticipated changes, and future needs. moreover, the role such a group could play in resolving disputes between entities involved in training and regulating the health care workforce would be as important as its role in guiding the development of the health care workforce. one example is the controversy around the varied scope of practice and inconsistent entry into practice among nurse practitioners and pharmacists practicing in different u.s. states. - also polemical are the conflicts of interest inherent in licensing entities that rely on income from test administration. , a group such as the national health care workforce commission could work to resolve these disagreements in a way that most benefits the population. since such a federal entity does not exist, addressing covid- requires urgent collaboration among nongovernmental groups that are involved in the transitions during training and into independent practice. meanwhile, these efforts should also seek to solve long-term disparities in access to care and health outcomes. collaboration might include organizations for each profession and across professions including but not limited to the following: . groups whose members have expertise in considering these issues, such as the coalition for physician accountability, through which physician organizations seek "to advance health care and promote professional accountability by improving the quality, efficiency, and continuity of the education, training, and assessment of physicians." transitions from each level of training to the next should be streamlined. educational programs, institutions sponsoring postlicensure training (e.g., residencies), and oversight entities need to implement processes that support trainees who have been designated as competent for the next level of independent practice. while competency-based programs have shown that many medical students can enter residency early, the rigidity of the fourth year of medical school remains a barrier. overcoming this barrier requires collaboration among-and potentially some sacrifice of control and income by-multiple stakeholders including the lcme, the national board of medical examiners, the national resident matching program, the acgme, schools of medicine, and even students. step demonstrate the capacity for this type of collaboration, and the aacn is working on new competency-based criteria for academic programs with the potential to move to time-variable clinical education. augmenting the pharmacy workforce will entail closer coordination between pharmd degree programs and pharmacy residencies. all these efforts require coordination and leadership. covid- has already led to adjustments in payment and more flexibility for telehealth. these changes were needed and should be formalized to address health inequities across the united states. in addition, transitioning to competency-based models may require more adaptable and increased support for gme, nursing education, and pharmacy education. as leaders define additional paths to a workforce better aligned with the needs of the population, payment must also change. health systems and other employers must ensure both the safety and competence of the bolstered workforce. as the workforce evolves, clinical leaders must not only be certain that standards of care are maintained but also be attentive to onboarding, orientation, entrustment, and supervision to ensure desired patient outcomes. relatedly, clinical leaders must support the safe practice of new health care workers trained under time-variable systems by appropriately assigning job duties-similar to processes for initiating new medical trainees in july. for example, preferentially assigning new workers to non-critical care units and granting responsibility commensurate with experience helps workers provide safe, effective, high-quality care. health care workers who undergo retraining or those who return from retirement to support the workforce during a crisis need similar support. everyone, especially novice practitioners, needs safe working conditions including readily available personal protective equipment. most importantly, system leaders must ensure adequate competency and standards of care, and they must provide feedback to training programs on deficiencies of recent graduates. covid- is a crisis that has already changed the approach to health professions training and care delivery in the united states. the challenge and resulting short-term adaptation represent an opportunity to address some of the long-standing inadequacies of the u.s. system. given the complexity of its regulatory, reimbursement, and oversight systems, transforming the u.s. health care workforce is a herculean task, and there are no easy paths forward. however, all of us are experiencing a time of unprecedented crisis, and now is the time to strengthen the health care workforce so we can emerge from covid- stronger than ever. funding/support: none reported. ensuring and sustaining a pandemic workforce addressing the physician shortage: the peril of ignoring demography health resources and services administration, national center for health workforce analysis. technical documentation for hrsa's health workforce simulation model workforce for st -century health and health care medical education in the united states and canada: forty-sixth annual report on medical education in the united states and canada by the council on medical education and hospitals of the american medical association origins of the physician assistant movement in the united states health care personnel delivery system (hcpds), federal register - lcme update of medical students, patients, and covid- : guiding principles for early graduation of final-year medical students three-year md programs: perspectives from the consortium of accelerated medical pathway programs (campp) three stages of gme during the covid- pandemic temporary waivers for regulations governing nursing education programs rounds with leadership: joining the conversation about competency-based education cooperative interstate registration system (resolution - - on step mania, usmle score reporting, and financial conflict of interest at the national board of medical examiners a crisis of trust between u.s. medical education and the national board of medical examiners the change to pass/fail scoring for step in the context of covid- : implications for the transition to residency process ethical approval: reported as not applicable. key: cord- -j r nq authors: hernando-amado, sara; coque, teresa m.; baquero, fernando; martínez, josé l. title: antibiotic resistance: moving from individual health norms to social norms in one health and global health date: - - journal: front microbiol doi: . /fmicb. . sha: doc_id: cord_uid: j r nq antibiotic resistance is a problem for human health, and consequently, its study had been traditionally focused toward its impact for the success of treating human infections in individual patients (individual health). nevertheless, antibiotic-resistant bacteria and antibiotic resistance genes are not confined only to the infected patients. it is now generally accepted that the problem goes beyond humans, hospitals, or long-term facility settings and that it should be considered simultaneously in human-connected animals, farms, food, water, and natural ecosystems. in this regard, the health of humans, animals, and local antibiotic-resistance–polluted environments should influence the health of the whole interconnected local ecosystem (one health). in addition, antibiotic resistance is also a global problem; any resistant microorganism (and its antibiotic resistance genes) could be distributed worldwide. consequently, antibiotic resistance is a pandemic that requires global health solutions. social norms, imposing individual and group behavior that favor global human health and in accordance with the increasingly collective awareness of the lack of human alienation from nature, will positively influence these solutions. in this regard, the problem of antibiotic resistance should be understood within the framework of socioeconomic and ecological efforts to ensure the sustainability of human development and the associated human–natural ecosystem interactions. the problem of antibiotic resistance (ar) has been traditionally addressed by focusing on humanlinked environments, typically health care facilities. nevertheless, it is now generally accepted that most ecosystems may contribute to the selection and spread of ar (aminov, ; martinez et al., ; davies and davies, ; martinez, ; berendonk et al., ; larsson et al., ) . a key conceptual point is that, based on cultural, humanitarian, and economic reasons, we have historically preserved the health of individual humans and farming animals. to that purpose, the same families of antimicrobial agents have been used. as a consequence, their positive (healing) and negative (selection of ar, therapeutic failure) effects have influenced the common health of humans and animals in particular locations (one health). the concept one health, first used in early twentieth century, expands the integrative thinking about human and animal medicine, including for the first time ecology, public health, and societal aspects (zinsstag et al., ) . in the case of ar, the one health perspective focuses on the risk assessment of emergence, transmission, and maintenance of ar at the interface between humans, animals, and any other linked (local) environment (robinson et al., ; jean, ) . consequently, the application of one health approaches demands integrative surveillance tools and interventions based on multidisciplinary approaches that include ecological and sociodemographic factors, besides more classic epidemiological models. global health is based on a broad collaborative and transnational approach to establish "health for all humans." in this case, it focuses ar at a general (global) scale, considering that the selection and global spread of antibiotic-resistant bacteria (arbs) and antibiotic resistance genes (args) are a problem that influences the health of human societies with disparate social and economic structures and is linked to many societal and ecological factors (chokshi et al., ) . interventions to reduce ar burden in a global world certainly require common and integrated policy responses of countries, international organizations, and other actors (stakeholders included). its goal is the equitable access to health and minimizing health risks all over the globe. besides its objective aspects (i.e., how travelers, migrating birds, or international commerce may contribute to ar spread), it has important international political aspects. it focuses in how countries and international organizations address the elements connecting and potentially spreading ar among humans, animals, and natural ecosystems at the earth scale (wernli et al., ) . in summary, the problems and the potential solutions concerning ar are not confined to particular regions, but have a global dimension: a problem for all humans, animals, and natural ecosystems, which should be solved with interventions aiming to improve health for all of them koplan et al., ; laxminarayan et al., ) . in the context of ar, a healthy environment would be an environment where ar is low or can be controlled by human interventions (hernando-amado et al., ; andersson et al., ) . of course, the global health concept of "health of an environment" (iavarone and pasetto, ; pérez and pierce wise, ; bind, ; van bruggen et al., ) or, in general, planetary health (lerner and berg, ) , has an unavoidable anthropogenic flavor. in practice, we consider "healthy environments" or "healthy ecosystems" those that minimize their current or their potential harm for the human individual or the society, in our case for ar. in other words, we adopt a selfish strategy, which should be necessarily implemented by the international (global) institutions. selfishness (kangas, ) applies mainly to individuals, but also to societal groups. however, these groups have not enough possibilities to act alone in the case of infectious diseases in general and ar in particular, which may expand worldwide. therefore, individual selfishness for health should be integrated in local one health and also in global health actions. the goal of controlling ar is a highly complex one, and its dimension has been compared to climate change or biodiversity loss, problems where individual actions are not enough for providing a solution, and consequently, individual freedom is confronted with collective responsibility (looker and hallett, ) . the construction of human societies reflects the tension between individual freedom and social rules/laws. the implementation of different social rules/laws for regulating human activities within a society is mainly based on moral (as kant's categorical imperative (kant, ) or religious-based brotherhood (matthew : - ) statements), social stability (as anticrime laws; schiavone, ) , organizative (type of government and how it is formed, group identity), and efficacy (as antitrust laws; ricardo, ) arguments. however, these arguments mainly apply for establishing the socioeconomic organization as well as the individual welfare within a society. the situation concerning human health is somehow different. there are individual diseases, such as cancer or stroke, and social diseases, such as transmissible infections. for the firsts, social norms (as consciousness of the importance of the control of cholesterol, excess sugar uptake, or hypertension levels) are well established, and even laws (non-smoking regulations) had been implemented in occasions. however, the main impact of these regulations is at the individual health level (wikler, ) , because the associated diseases are not physically transmissible. a different situation happens in the case of infectious diseases in general and of ar in particular. for these diseases, everything that happens in a single person affects any one around. further, the fact that an arg emerging in a given geographic area can spread worldwide implies that neither individual norms nor country-based norms have been sufficient until now to counteract the worldwide spread of ar. one important aspect of laws in democratic societies is that they must be well accepted by the community, so that the acceptation of social norms usually comes first than their implementations as rules/laws. actually, the efficiency of democracy for responding to social crisis (as current ar or covid- crises), in opposition to other more autocratic regimens where decisions are implemented top-down, had been the subject of debate from the early beginning of democratic revolutions (tocqueville, ; hobbes, ; rousseau, ; spinoza, ) . in this regard, it is important to remark that one health aspects of ar can be tackled in the basis of countrylevel regulations that are linked to the socioeconomic and cultural aspects of each country (chandler, ; chokshi et al., ) . however, because global earth governance does not exist, global health control of ar is based on recommendations, rather than in rules/laws. consequently, the acceptance of social norms, starting within individuals or small organizations and expanding throughout the whole society (figure ) , is fundamental to provide global solutions to the ar problem (nyborg et al., ; chandler, ) . the acceptance by the community of these social norms, considering that the way of promoting these norms might differ in different parts of the world (cislaghi and heise, ; cislaghi and heise, ) , largely depends on the transfer to the society of the knowledge required to understand the mechanisms and the impact for human health of the emergence and transmission of ar, an information that is discussed below. figure | how the interactions among individual health, one health, global health, and social norms influences antibiotic resistance. the right panel shows the different levels of dissemination of antibiotic resistance. in the left panel, the different types of norms (from individual to global norms) that can impact antibiotic resistance at each level are shown. these norms influence all levels of transmission: the individual promotes (red arrows) his own individual health, but doing it also promotes the health of the group, and the health of the group promotes global health of the human society at large. at each level, there is a positive action (red broken lines) on antibiotic resistance. such dynamics largely depends on social norms (blue arrows) rewarding the individual or the groups whose behavior promotes health. below the left panel, the basic social norm, progress and development, has consequences on the whole ecobiology of the planet (lower panel with bullet points), influencing the undesirable open circulation of antimicrobial resistant bacteria (with their mobile genetic elements) and antibiotic resistance genes. the classic definition of ar is based only on the clinical outcome of the infected patient. an organism is considered resistant when the chances for the successful treatment of the infection it produces are low . this definition, which is the most relevant in clinical settings, presents some limitations for studies based on one health approaches that include the analysis of non-infective organisms, which lack a clinical definition of resistance, as well as analysis of the distribution of args, in several occasions, using non-culture-based methods . even in the case of animal medicine, antibiotic concentration breakpoints defining resistance are still absent for some veterinary-specific antimicrobials and poorly defined for different types of animals with disparate weights, which would influence the availability of the drug inside animal body (toutain et al., ; sweeney et al., ) . to analyze ar beyond clinical settings, the term resistome, understood as the set of genetic elements that can confer ar, irrespectively of the level of resistance achieved, in a given organism/microbiome was coined (d'costa et al., ; wright, ; perry et al., ) . ar acquisition is the consequence of either mutation (or recombination) or recruitment of args through horizontal gene transfer (hgt), transformation included. ar mutations are generally confined to their original genomes, propagating vertically and not spreading among bacterial populations, although some few exceptions of horizontal transfer of chromosomal regions containing ar mutations have been described (coffey et al., ; ferrandiz et al., ; novais et al., ; nichol et al., ) . the set of mutations that confer ar can be dubbed as the mutational resistome. current wholegenome-sequencing methods of analysis can allow defining the mutational resistome in an isolated microorganism (cabot et al., ; lopez-causape et al., ) . however, they are not robust enough yet for determining the mutational resistome in metagenomes. consequently, the impact of these analyses in one health studies is still limited and will not be further discussed in the present review. concerning their relevance for acquiring ar, args can be divided in two categories. the first one comprises the genes forming the intrinsic resistome (fajardo et al., ) , which includes those that are naturally present in the chromosomes of all (or most) members of a given bacterial species and have not been acquired recently as the consequence of antibiotic selective pressure. despite that these genes contribute to ar of bacterial pathogens, they are responsible just for the basal level of ar, which is taken into consideration when antibiotics are developed. in this regard, unless these genes, or the elements regulating their expression mutate, they are not a risk for acquiring resistance and have been considered as phylogenetic markers . further, it has been discussed that these genes may contribute to the resilience of microbiomes to antibiotic injury (ruppe et al., b) , hence constituting stabilizing element of microbial populations when confronted with antibiotics more than a risk for ar acquisition by pathogens. the second category, dubbed as the mobilome, is formed by args located in mobile genetic elements (mges) that can be transferred both vertically and horizontally, hence allowing ar dissemination among different bacteria (frost et al., ; siefert, ; jorgensen et al., ; lange et al., ; martinez et al., ) . while the analysis of the resistome of microbiota from different ecosystems has shown that args are ubiquitously present in any studied habitat (d'costa et al., ; walsh, ; jana et al., ; lanza et al., ; chen et al., b) , the impact of each one of these args for human health is different. indeed, it has been stated that the general resistome of a microbiome is linked to phylogeny and to biogeography, indicating that most args are intrinsic and do not move among bacteria (pehrsson et al., ) . however, some args escape to this rule and are shared by different ecosystems and organisms (forsberg et al., ; fondi et al., ) . these mobile args, frequently present in plasmids (tamminen et al., ; pehrsson et al., ) , are the ones that are of special concern for human health. although not belonging to the antibiotic resistome, genes frequently associated with resistance to other antimicrobials, such as heavy metals or biocides, as well as the genes of the mges backbones, eventually involved in the transmission and selection of args among microbial populations, the mobilome at large, are also relevant to track the emergence and dissemination of ar among different habitats martinez et al., ; baquero et al., ) . hgt processes are recognized as the main mechanisms for transmission of genetic information (baquero, ) . from the ecological point of view, hgt should be understood as a cooperative mechanism that allows the exploitation of common goods as args by different members within bacterial communities. in fact, some studies suggest that the ecological consequences of hgt events in ar evolution are contingent on the cooperation of complex bacterial communities, besides the acquisition of individual adaptive traits (smillie et al., ) . however, the understanding of the ecological causes and consequences of args transmission among organisms and microbiomes is still limited from the one health and global health perspectives. hgt-mediated ar is a hierarchical process (figure ) in which args are recruited by gene-capture systems as integrons and afterward integrated in mges as plasmids, insertion conjugative elements, or bacteriophages (frost et al., ; garcia-aljaro et al., ; gillings et al., ; botelho and schulenburg, ) , which afterward are acquired by specific bacterial clones. selection at each of these levels will also select for all the elements involved in ar spread. for instance, the acquisition of an arg by a clone may promote the expansion of the latter (and of all the genetic elements it contains, other args included) in antibiotic-rich environments, such as hospitals or farms schaufler et al., ) , and vice versa, the introduction of an arg in an already successful clone may increase the chances of this resistance gene for its dissemination even in environments without antibiotics, unless the associated fitness costs are high. in this sense, if arg acquisition reduces the fitness, and this implies a decreased capability for infecting humans (see below), the burden for human health might eventually be lower. nevertheless, it is relevant to highlight that ar transmission cannot be understood just by analyzing the genetic mechanisms involved and the consequences of such acquisition for the bacterial physiology. indeed, as discussed below, there are ecological and socioeconomic elements that strongly influence ar dissemination. the evolution of ar comprises the emergence, the transmission, and the persistence of arbs (martinez et al., ; baquero et al., ) . concerning human health, selection of arbs/args is particularly relevant at the individual health level, whereas transmission is a main element to be taken into consideration at the one health and global health levels (figure ) . indeed, unless ar is transmitted, it will be just an individual problem that would not affect the community at large. it is generally accepted that non-clinical ecosystems are often primary sources of args (davies, ) . as above stated, after their capture and integration in mges (figure ), args and their bacterial hosts can contaminate different ecosystems, which might then be involved in their global spread (martinez, ; fondi et al., ; gillings, ; gillings et al., ) . this means that nearly any ecosystem on earth, along with the humandriven changes produced in it, may modulate evolution of ar. importantly, the huge escalation and worldwide expansion of a limited set of animals, plants, and their derived products, including foods, due to the anthropogenic selection of a few breeds and cultivars for mass production in livestock and agricultural industries (okeke and edelman, ; zhu et al., ) of economic interest have collapsed the variability and biodiversity of animals and plants (seddon et al., ) . because these organisms harbor particular host-adapted bacteria, which are frequently under antibiotic challenge, this situation, together with the ecological similarities of human habitats, might favor ar spread (martiny et al., ; manyi-loh et al., ) . indeed, while in underdeveloped areas of the world food animals are very diverse, intensive farming, common in developed countries, ensures a "shared-stable" environment where only the most productive types prevail (kim et al., ) . the common genetic origin of these types and the process of microbiota acquisition from nearby animals in intensive farming should homogenize also their microbiomes with consequences for ar dissemination. actually, it has been shown that the loss of microbial diversity figure | genetic, ecological, and socioeconomic elements mediating the transmission of antibiotic resistance. args are ubiquitously present in any studied microbiome (a). however, only a few of them are transferred to human/animal pathogens, hence constituting a health problem. the genetics events implied include the acquisition of args by gene-recruiting genetic elements such as integrons (b); the integration of these elements in mges as plasmids, bacteriophages, or frontiers in microbiology | www.frontiersin.org figure | continued insertion conjugative elements (c); and the acquisition of these elements by specific bacterial clones (d). these arbs can share these elements among the members of gene-sharing communities (e) and also move among different ecosystems, including humans, animals (particularly relevant farm animals), and natural ecosystems (with a particular relevance for water bodies). the connection of these ecosystems, as well as the reduced diversity of animals, plants, and in general habitats as the consequence of human activities, allows the different microbiomes to be in contact, favoring args transmission among the microorganism they encompass (f). this transmission is facilitated at the global scale by travel, animal migration, trade of goods, and eventually by meteorological phenomena, climate change included (g), hence producing a global health problem (h). while most studies on the dissemination of args focus on mges (davies, ; muniesa et al., ; lanza et al., ; garcia-aljaro et al., ) , recent works suggest that the contribution of natural transformation (orange arrow), allowing the direct uptake of args by natural competent microorganisms, may have been underestimated (domingues et al., ; blokesch, ) . further, competence can occur due to interbacterial predation (veening and blokesch, ) , a biological interaction that may facilitate the acquisition of beneficial adaptive traits by predator bacterial species (cooper et al., ; veening and blokesch, ) . other hgt mechanisms, such as dna packing in extracellular vesicles (ecv) or transference of dna through intercellular nanotubes, also seem to be relevant in nature (dubey and ben-yehuda, ; fulsundar et al., ) . while the biotic conditions that may enhance hgt have been studied in detail, less is known concerning abiotic modulation of args transfer. under contemporary conditions, at least microorganisms are affected by a freeze-and-thaw cycle, at least are agitated by sand, and at least are subjected to conditions suitable for electrotransformation every year (kotnik and weaver, ) . may favor ar spread (chen et al., a) . note that, beyond the transmission of particular ar spreading clones, ar is expected to spread in farms by the modification (eventually homogenization) of animals' microbiota. notwithstanding, even farm workers are subject to microbiome acquisition from animals, leading to microbiome coalescence sun et al., ) . it is to be noticed, and the recent covid- crisis exemplifies it, that besides economic development, cultural habits are relevant in the use of animals for food, a feature that has not been analyzed in detail, particularly with respect to their role as vectors potentially involved in ar dissemination. despite that the homogenization of hosts may help in ar transmission, the spread of arbs has some constraints, because the differential capability of each bacterial clone for colonizing different hosts may modulate their dissemination. indeed, while some species and clones are able to colonize/infect different animal species, humankind included, several others present some degree of host specificity (price et al., ; sheppard et al., ) . further, it has been shown that the capacity to colonize a new host is frequently associated with a reduction in the capacity for colonizing the former one. the same happens for mobile args; they are encoded in mges that present different degrees of host specificity, which defines the formation of gene-exchange communities, where the interchange of genetic material among members is facilitated (skippington and ragan, ) . conversely, the incorporation of different replicons and modules within plasmid backbones, a feature increasingly reported (douarre et al., ) , would enable arg replication in different clonal/species background and thus modify the community network of args. actually, the risk for humans of animal-based ar seems to be linked in most cases to shuttle, generalist clones able to colonize humans and particular animals (price et al., ; sheppard et al., ) . the understanding of the elements driving the transfer of ar among animals, humans included (figure ) , requires the comprehensive survey of the clones and args that are moving among them (european food safety authority et al., ). tools to track the global epidemiology of antimicrobial-resistant microorganisms such as bigsdb (jolley et al., ) or comprehensive databases of args, ideally providing information of their mobility (zankari et al., ; alcock et al., ) , are fundamental for studying ar transmission at a global level. it is worth mentioning that, because humans constitute a single biological species, the human-associated organisms spread easily among all individuals. in fact, more prominent differences in humans' microbiome composition can be observed between individuals than among ethnic groups, even though, as expected, the resemblance in microbiotas is higher among those groups that are geographically clustered (deschasaux et al., ; gaulke and sharpton, ) . some groups of human population are, however, more prone to acquire arbs, due either to socioeconomic or to cultural factors. in lmics (low-to medium-income countries) and brics (brazil, russia, india, china, and south africa) countries, the combination of wide access to antibiotics, weak health care structures, and poor sanitation defines certainly a dangerous landscape. moreover, the progressive aging of the western population might favor the establishment and further expansion of an elderly reservoir of arbs and args, an issue that deserves further studies. the hypothesis that the microbiome of elder people might be a reservoir of ar is based not only on their cumulative history of antibiotic exposure and contacts with health care centers, but also on the rampant use of antibiotics of this population more prone to suffer from acute, chronic, or recurrent infections. significant worldwide advances in the organization of medical care of the elderly people lead to frequent hospitalizations, but health care centers may also facilitate the selection and further amplification of ar in the community. in addition, this may subsequently favor the entry of high-risk clones and of args in the hospital setting (hujer et al., ) . as stated above, there is a global increasing permeability of the natural biological barriers that have historically prevented bacterial dissemination through different ecosystems. besides local spread of ar in environments shared by animals and humans, which has to be addressed under a one health approach, ar can disseminate worldwide (figure ) by economic corridors that promote the global interchange of goods and trade or human travelers or by natural bridges, such as animal migration paths or natural phenomena such as air and water movements (okeke and edelman, ; baquero et al., ; allen et al., ; overdevest et al., ; kluytmans et al., ; fondi et al., ) . the result is the appearance of similar arbs and args in different geographic areas. as the consequence, ar is a global health problem in the sense that an arb that emerges in a given place can rapidly spread worldwide. indeed, multidrugresistant bacteria, similar to those encountered in clinical settings, have been detected in human isolated populations that were not previously in contact with antibiotic, as well as in wildlife (clemente et al., ) . this indicates that pollution with args is present even in places where antibiotic concentrations are low (kümmerer, ) and might involve mechanisms of transmission that do not require selection. for instance, migrating birds can carry enteropathogenic bacteria resistant to different antibiotics (middleton and ambrose, ; poeta et al., ) , and international travelers, even those not receiving antibiotic treatments, also contribute to ar transfer among different geographic regions (murray et al., ; reuland et al., ) . in the group of long travelers are refugee people, in which dissemination of multidrug-resistant strains is favored by the poor sanitary conditions and overcrowding camps that refugees confront (maltezou, ) . a final issue concerning ar is its stability in the absence of selection. it has been proposed that the acquisition of ar reduces bacterial competitiveness in the absence of antibiotics (fitness costs) (andersson and hughes, ; martinez et al., ) ; certainly, a wishful proposition such as, if true, the reduction in the use of drugs or eventually antibiotic-cycling strategies should decrease ar (beardmore et al., ) . nevertheless, eliminating the use of an antibiotic does not produce a full decline of ar (sundqvist et al., ) . in fact, different studies have shown that ar not always reduces fitness but also can even increase bacterial competitiveness (andersson and hughes, ; schaufler et al., ) . in addition, compensatory mutations or physiological changes that restore fitness can be selected in resistant bacteria (andersson, ; schulz zur wiesch et al., ; olivares et al., ) . it is a fact, however, that although arbs are found nearly everywhere, including wild animals, natural ecosystems, or people from isolated populations without contact with antibiotics, among others (durso et al., ; clemente et al., ; alonso et al., ; fitzpatrick and walsh, ; power et al., ) , ar prevalence is consistently lower when antibiotics are absent, which suggests that pollution may impact ar, a feature that is discussed below. pollution of natural ecosystems is associated with activities that have driven relevant economic transition, in principle favoring human welfare, such as mining, industry, intensive land use, or intensive farming, among others. notwithstanding, globalization of health services, as well as the shift toward intensive farming, besides their positive contribution to human wellbeing, has rendered an increasing pollution by compounds with pharmacological properties of natural ecosystems, particularly water bodies, which may disrupt the stability of these ecosystems (oldenkamp et al., ) . among them, antibiotics are considered the most relevant cause of ar selection. despite regulations for reducing their use (van boeckel et al., ) , a substantial increase in global antibiotic consumption has occurred in the last years, and an even greater increase is forecasted in the next years (klein et al., ) . however, antibiotics are not the unique pollutants that can prime the selection and spread of ar. in this regard, it is important to highlight that heavy metals are one of the most abundant pollutants worldwide (panagos et al., ) . their abundance results from anthropogenic-related activities, such as mining, industry, agriculture, farming, or aquaculture and even for therapeutic use in ancient times. importantly, they may persist in nature for long periods of time. further, likely because metal pollution occurred before the use of antibiotics, heavy metal resistance genes were incorporated to mge backbones before args (mindlin et al., ; staehlin et al., ) . this means that heavy metals may coselect for mges and the args they harbor (partridge and hall, ; staehlin et al., ; zhao et al., a) . even more, the presence of heavy metals, as well as of biocides or sublethal antibiotic concentrations (jutkina et al., ; zhang et al., ) , may stimulate hgt, as well as modify the dynamics of antibiotics, such as tetracyclines, in natural ecosystems (hsu et al., ) . coselection may also occur when a single resistance mechanism, such as an efflux pump, confers resistance to both heavy metals and antibiotics (cross-resistance) (pal et al., ) . although most published works analyze the effect of different pollutants on their capacity to select arbs or args, it is important to highlight that args should also be considered pollutants themselves. actually, a recent work indicates a close relationship between the abundance of args and fecal pollution (karkman et al., ) . in this respect, it is worth mentioning that, differing to classic pollutants, args/arbs are not expected to disappear along time and space, but rather, their abundance may even increase as the consequence of selection and transmission (martinez, ) . while the direct selection of ar by antibiotics or the coselection mediated by other pollutants, as the aforementioned heavy metals, has been discussed (wales and davies, ) , the effect of other types of human interventions on the dissemination of args and arbs through natural ecosystems has been analyzed in less detail. as an example, it has been proposed that wastewater treatment plants, where commensals, arbs, args, and antibiotics coexist, could act as bioreactors favoring the selection and transmission of args between different organisms (rizzo et al., ; su et al., ; manaia et al., ) , although evidences supporting this statement are scarce (munck et al., ; azuma et al., ) . in addition to the aforementioned pollutants with a direct effect in ar selection, it is worth noting that there are other abundant contaminants, such as sepiolite (present in cat litters or used as a dietary coadjuvant in animal feed) or microplastics, present in almost all aquatic ecosystems, which can favor the transmission of args or mges between bacterial species (rodriguez-beltran et al., ; kotnik and weaver, ; arias-andres et al., ) , hence amplifying the ar problem at a global scale. finally, the possible effect of climate change on the spread of ar is worth mentioning. indeed, it modifies the biogeography of vectors (such as flies, fleas or birds) involved in the spread of infectious diseases (fuller et al., ; beugnet and chalvet-monfray, ) . in addition, the increase of local temperatures seems to correlate with an increased ar abundance in common pathogens (macfadden et al., ) . besides, climate change is affecting ocean currents (martinez-urtaza et al., ) , which may allow the intercontinental distribution of arbs and args (martinez, a,b) . although this phenomenon might contribute to the globalization of ar, further research is needed to clearly demonstrate a cause-effect relationship. it is relevant to mention that increased pollution and climate change are the unwanted consequences of human development. it would then be worth discussing how human development in general may impact (positively and negatively) ar, a feature that is analyzed below. human development is a necessity of our human behavior, although different models of development have been and are proposed, each one producing different impacts in the structure of human societies and on the preservation and stability of natural ecosystems (fenech et al., ; farley and voinov, ; seddon et al., ) . nevertheless, even for different socioeconomic models, there are some social norms that tend to be widely accepted, in particular those aiming to improve individual well-being. this implies the establishment of a society of welfare, understood as a right of any human on earth, a feature that depends on the economic development, and can be particularly relevant in the case of transmissible infectious diseases in general and of ar in particular. a continuously repeated mantra in worldwide ar policies is that the abusive consumption of antibiotics for the treatment or prevention of infections in humans and animals constitutes the major driver of ar. however, we should keep in mind that antibiotics constitute an important example of human progress supporting individual and global human health. in fact, the origin of the massive production of antimicrobials was a consequence of the needs resulting from world war ii in the s. this was followed by many decades of human progress, most importantly by the common understanding of equal human rights, which was followed by the economic and social development (including medicine and food industry) of densely populated regions in the planet, including india and china. these countries are currently among the leaders in the production and consumption of antimicrobial agents. notwithstanding, as in any area of economy, progress bears a cost that, in this case, is antibiotic pollution of the environment, globally accelerating the process of the emergence, the transmission, and the persistence of arbs (martinez et al., ; baquero et al., ) . the non-controlled use of antibiotics is facilitated in lmics with disparate economic growth by different factors. heterogeneous regulation of antibiotic sales and prescriptions (often weak or missing) and the increase of online on-bulk sales in recent years contribute to their overuse (mainous et al., ). most of live-saving medicines represent out-of-pocket costs in most lmics, which led to an exacerbated use of cheap (usually old and less effective) antibiotics, phasing out their efficacy and increasing the demands and prices for the most expensive ones, eventually resulting in treatment unavailability (newton et al., ) . further, the cost of treating ar infections is much higher than that of treating susceptible ones, which is increasing the cost of health services (wozniak et al., ) . conversely, the growing economic capability of lmics in the brics category triggers the access of the population to health services and last-resort antibiotics. these countries also face a sudden high demand for meat and thus a prompt industrialization of animal production that has favored the misuse of antibiotics for growth promotion facilitated by their online availability (mainous et al., ). in addition, counterfeit or substandard antibiotics recently become a serious global problem (gostin et al., ) , which is exacerbated in lmics, where they represent up to a third of the available drugs. noteworthy, % of all reports received by the who global surveillance and monitoring system on substandard and falsified medicines worldwide come from africa, and most of them correspond to antimalarials and antibiotics (newton et al., ; gostin et al., ; hamilton et al., ; petersen et al., ) . despite this situation, it is important to highlight that human consumption of antibiotics is an unavoidable need to preserve human health. in fact, most health problems dealing with infections in lmics are still caused by a poor access to antibiotics, not by an excessive use of them. proof of this is the fact that the distribution of antibiotics has reduced endemic illnesses and children mortality in sub-saharan africa (keenan et al., ) . this means that, while a global decline in the use of antibiotics would be desirable to diminish the problem of ar, there are still several parts in the globe where antibiotic use should still increase to correctly fight infections. in fact, our primary goal should not be to reduce the use of antibiotics, but to ensure the effective therapy of infectious diseases for the long term. this does not mean that ar is not a relevant problem in lmics; it means that reducing antibiotic use is not enough to solve the problem. indeed, the current high morbidity and mortality due to infectious diseases (malaria, tuberculosis, low respiratory infections, sepsis, and diarrhea) in lmics will be worsened in the absence or low efficiency of therapeutic treatments. further, ar has economic consequences. according to world bank, . million people could fall into extreme poverty by because of ar, most of them from lmics (jonas and world bank group team, ) . consequently, besides a global health problem, ar has an important economic impact (rudholm, ) , hence constituting a global development problem, endangering not only the achievements toward the millennium development goals but also the sustainable development goals (van der heijden et al., ). world bank estimates that ar could impact the gross domestic product from to . %, which is even higher than what is estimated for the climate change (jonas and world bank group team, ) . these economic foresights are linked to the threads of increased poverty, food sustainability, global health deterioration (associated with both food safety and affordability to health care), and environment protection. all these issues are also impacted by the overuse and misuse of antibiotics, its lack of effectiveness, and the affordability to medicines and health care (van der heijden et al., ) . when talking about reducing antibiotic consumption, it is important to remind that up to two-thirds of overall antibiotic usage is for animal husbandry (done et al., ) . further, recent work states that the use of antibiotics in crops, particularly in lmics, might have been largely underestimated (taylor and reeder, ) . despite that evidences on the presence of common args distributed among animals and humans were published decades ago wegener et al., ; aarestrup, ; aarestrup et al., ) , and although the use of antibiotics as growth promoters has been banned in different countries (cox and ricci, ) , they are still allowed in many others (mathew et al., ) . of relevance is the fast increase of antibiotic consumption for animal food production in china ( % in ) and other brics countries . as stated previously, in these countries, increased income has produced a fast increase in meat products demand, due to changes in diet of their population. in addition, the increasing international competitiveness in meat production of these countries has fostered the rampant development of their industrial farming. together with the fact that legislation on antibiotics use remains weak, this situation increases the risk of emergence of ar linked to animal production. nevertheless, the problem is not restricted only to lmics, because antibiotics consumption rose as well in the highincome countries as the united states ( %) , where approximately % of the antimicrobials purchased in were applied in livestock production as non-therapeutic administration (done et al., ) . the development of intensive methods of fish production has also contributed to the rise in the use of antimicrobials and the selection of resistance determinants that can be shared among fish and human bacterial pathogens (cabello et al., ) . economic development has facilitated as well more global transport, waste disposal, and tourism, favoring ar spread within and between different geographical areas (ruppe et al., a; ruppe and chappuis, ) . however, economic growth can also reduce the ar burden, especially when it enables the development of regulations and infrastructures that might reduce the risks of infection and ar spread. this is particularly relevant in the case of public health interventions on food, water, and sewage. because ar pathogens are mainly introduced in natural ecosystems through the release of human/animal stools (karkman et al., ) , the best way of reducing this impact is through the use of wastewater treatment plants, which are still absent in several places worldwide. indeed, it has been described that drinking water is a relevant vehicle for the spread of arbs in different countries (walsh et al., ; fernando et al., ) and that raw wastewater irrigation used for urban agriculture may increase the abundance of mobile args in the irrigated soil (bougnom et al., ) . notably, the analysis of args in wastewaters has shown that the prevalence of args in the environment in each country might be linked to socioeconomic aspects mainly related to economic development, as general sanitation, particularly the availability of drinking and wastewater treatments, malnutrition, number of physicians and health workers, human overcrowding, or external debt grace period (hendriksen et al., ) . the field of ar has mainly focused in the mechanisms of selection; the main driver for the increased burden of ar would be then the use of antibiotics itself. however, these results indicate that transmission, even in the absence of direct human-to-human contact, might be, at least, equally relevant. in this situation, an important element to reduce the ar burden will be to break the transmission bridges among different ecosystems that could be reservoirs of args. even when wastewater-treatment plants are available, the presence of arbs in drinking, fresh, and coastal waters, as well as in sediments nearby industrial and urban discharges, has been described in several countries (ma et al., ; leonard et al., ) . as in the case of fecal contamination markers, a reduction in the amount of args to non-detectable levels would be extremely difficult even when advanced water treatment procedures are applied. a standard definition of polluting arb/arg markers, as well as their acceptable levels, is then needed. this would be required not only for potable water, but also for water reutilization, as well as for land application and release of sewage effluents, because in all cases the reused water/sewage may carry arbs and args, together with pollutants, such as antibiotics, metals, biocides, or microplastics, which, as above stated, may select for ar (baquero et al., ; moura et al., ; yang et al., ; zhu et al., ; larsson et al., ; imran et al., ; wang et al., ) and may even induce hgt. the examples discussed above justify that human health in general and ar in particular are closely interlinked with economic development (sharma, ) . economic differences are also found at individual level, because there is a positive relationship between economic status and health (tipper, ) . in addition, social behavior might also impact ar, a feature discussed in the following section. different socioeconomic factors can modulate the spread of infective bacteria in general and of ar in particular. among them, the increasing crowding of humans and foodborne animal populations favors transmission at the local level (one health), whereas trade of goods and human travel (figure ) favor worldwide transmission (global health) (laxminarayan et al., ; hernando-amado et al., ) . besides these global changes in social behavior, linked to economic development, more specific socioeconomic factors (income, education, life expectancy at birth, health care structure, governance quality), sociocultural aspects (inequalities, uncertainty avoidance, integration of individuals into primary groups, gender biases, cultural long-term orientation), and personality dimension highly influence antibiotic use and ar transmission (gaygısız et al., ) . for instance, although the governance quality seems to be the most important factor associated with a proper antibiotic use, western countries with distinct national culture patterns show different levels of antibiotics consumption (kenyon and manoharan-basil, ) . a better understanding of human social responses facing ailments, especially epidemics and antibiotic use, requires then a more detailed analysis of the differences between collectivistic (individuals living integrated into primary groups) and individually long-term oriented societies (oriented to future individual rewards) (hofstede, ; gaygısız et al., ; kenyon and manoharan-basil, ) . consistent with the sociological elements of ar, many of the aspects influencing ar reviewed above depend on social norms (figure ) . in the classic view of the psychoanalyst erich fromm presented in his book "escape from freedom" (fromm, ) , human individual behavior is oriented to avoid being excluded from a higher social group. indeed, not following social common rules can be eventually considered as a mental disorder; a sociopathology. a social norm is defined as a predominant behavioral pattern within a group, supported by a shared understanding of acceptable actions and sustained through social interactions within that group (nyborg et al., ) . in democratic societies, laws usually derive from already accepted social norms; otherwise, they would be changed, and in that sense, the establishment of accepted social norms for fighting ar is a prerequisite to implement the global approaches, based on worldwide rules, which are required for tackling this relevant problem. interestingly, the ar problem is a bottom-up process, where small emergent changes (in some type of individual patients, in some groups, in some locations) cumulatively escalate to gain a global dimension. frequently, that occurs by crossing tipping points, that is, points where the local ar incidence becomes significant enough to cause a larger, eventually global, health problem. because of that, the implementation of solutions should be adapted to the control of critical tipping points in the small groups of individuals to disrupt the bottom-up processes. however, as ar spread can occur everywhere and at any time, global surveillance and mechanisms of control should be implemented to prevent a top-down process of global ar expansion. individual selfishness for ar is the cornerstone of social norms. this concept was coined and developed by one of us over a decade ago (baquero, ) . let us imagine that each individual is aware that each consumption of an antibiotic increases the personal risk of himself/herself or for his/her closer relatives (frequently exchanging microorganisms) of dying because of an antibiotic-resistant infection. the situation is analogous to the consumption of cholesterol-rich or highly salted food, or drinks with excess of sugar, concerning individual health. however, in the case of ar, it requires the understanding of the impact of individual actions at the global level. in this respect, anti-ar social actions should resemble more antitobacco and even general pollution/ecological campaigns. at the individual level, there is inertia that precludes changing habits, until a tipping point is crossed and health is compromised. the conclusions of studies mainly based on long-term cohort analysis, such as the framingham program for the influence of diet or smoking on personal cardiovascular disease (mahmood et al., ) , have become social norms that are naturally imposed by the ensemble of individuals. this creates a kind of societal culture, leading to appropriate individual behaviors, in occasions without the need of specific laws (diet), in occasion favoring the implementation of such laws (antismoking). however, we lack similar studies on issues such as these dealing with personalfamiliar risks that have successfully shifted social norms, driven by groups of individuals and based on the promotion of individual behaviors in the case of ar. despite that quantitative models on how individual antibiotic use may impact ar at the population level are still absent, it is worth mentioning that a reduced antibiotic consumption has also begun to occur in a number of countries just as a result of a change in individual behavior (edgar et al., ) , and some tools and indicators to address these changes have been suggested (ploy et al., ) . the "tragedy of the commons" metaphor, first proposed in the xix century (lloyd, ) and later on discussed in (hardin, ) , has been used for addressing the sociology of ar, by showing how individual selfishness promotes antibiotic use, increases resistance, and influences the health of the community by impairing antibiotic efficacy (baquero and campos, ; foster and grundmann, ) . ensuring the prestige of individuals that follow the social rules is needed to counteract the tragedy of the commons. nevertheless, it is important noticing that the tension between individual freedom and social rules that is inherent to the construction of democratic societies (tocqueville, ; hobbes, ; rousseau, ; spinoza, ) also applies here. one example of this situation is vaccination, considered in the last century as one of the most important advances to fight infectious diseases and now being the focus of antivaccination campaigns (megget, ) , a movement that has been considered by the who as one of the top global health threats of . it is commonly accepted that social norms are mainly created by learning and education, a rational path that promotes health (chen and fu, ) . also, the increasing activities of "personalized medicine, " including antibiotic stewardship, follow the same trend (gould and lawes, ) . however, the antivaccination movement is an example of how the narrative, as well as the use of decentralized, social information channels such as the internet search, blogs, and applications to facilitate communication such as twitter, facebook or whatsapp, is of particular relevance in the construction of social norms, not necessarily based on scientific and rational grounds (jacobson et al., ; scott and mars, ) . the impact of social norms goes beyond human societies as human activities alter natural ecosystems; consequently, humans cannot be aliens of nature. we should then shape a socioecological system, linking the individuals, the groups, and the entire society, as well as natural ecosystems, also potentially damaged by ar, in a common multilevel adaptive system based on social norms and policies at the individual, local (one health), and global (global health) scale (levin et al., ) . the recent crisis of covid- illustrates the influence of social norms in the individual behavior. each one of the individuals, protecting himself/herself, also protects the others. a person not wearing on face mask is frowned upon, and on the contrary, somebody attaching to the rules increases reputation. the individual adopts the right behavior being influenced by the judgment. of others. in addition, different political regimes (democracy or autocracy), as well as their organization (centralized, federal), together with the capacity of the health services to support the norms and their efficacy to communicate the chosen policy to the citizenry, may shape the individual responses to social norms (greer et al., ; häyry, ; kavanagh and singh, ) . notwithstanding, two reasons that have been proposed to explain the low prevalence of covid- in japan were related with social norms more than with biological issues. these reasons, which are not common to other countries, were the socially accepted use of face masks and the mandatory vaccination of all the population against tuberculosis, which might protect from sars-cov- infection (iwasaki and grubaugh, ) , a feature that is still to be confirmed. the loss of social prestige of individuals taking antibiotics without prescription, as well as the pharmacies delivering these drugs or do not respect environmental protection, or the overconsumption of antibiotics in hospitals or in farms, or even in certain countries, is progressively constituting a "social norm, " converted in rules able to reduce ar emergence and spread. of course, family and school education, as well as governmental campaigns, including the use of social media (grajales et al., ) reinforces such social norms, which could allow the support of the society for the implementation of different interventions, some of them described below. controlling resistance not only requires establishing local interventions, which could be relatively easily implemented, but would also require global interventions that every country should follow, despite their disparate regulatory systems. local and global interventions are necessarily intertwined; for example, the use of a new drug to treat a single individual depends on regulations at the county level (one health approach), but the worldwide prevalence and transmission of resistance to this drug, as well as the regulations of its use, should be established internationally (global health approach). three main interventions to tackle ar have been historically considered: first, reduction of the antibiotic selective pressure by decreasing antimicrobials use; second, reduction of transmission of arbs using improved hygienic procedures that prevent spread; third, development of novel antimicrobials with limited capacity to select arbs or the design of new treatment strategies based on use of non-antibiotic-based approaches or, more recently, on the exploitation of trade-offs associated with ar evolution (imamovic and sommer, ; gonzales et al., ; barbosa et al., ; imamovic et al., ) . these interventions have been basically limited to local initiatives, applied mainly to hospitals and, more recently, to farms. however, ar has emerged and spread globally, in bacteria from different environments, so the health and dynamics of the global microbiosphere could be affected by antibiotics. in a sense, ar is affecting the planetary health (lerner and berg, ) , and the needed interventions for tackling this problem cannot be restricted to hospital settings (figure ) . the proposed reduction in the use of antibiotics (blaskovich, ) must be compensated with alternative approaches for fighting infectious diseases. in this regard, strategies based on improving the capability of the immune system for counteracting infections (levin et al., ; traven and naderer, ) or the use of non-antibiotic approaches to prevent them, such as vaccines (jansen and anderson, ) , may help to reduce the burden of ar infections. indeed, vaccination against haemophilus influenzae and streptococcus pneumoniae has been demonstrated to be an effective intervention for reducing ar (jansen and anderson, ) . however, while vaccination has been extremely useful to prevent viral infections, it has been less promising in the case of bacterial ones. recent approaches, including reverse vaccinology, may help in filling this gap (delany et al., ; ni et al., ) . moreover, vaccination should not be restricted to humans, because veterinary vaccination can also contribute to animal wealth and farm productivity (francis, ) . besides, the use of vaccines in animal production reduces the use of antibiotics at farms/fisheries, hence reducing the selection pressure toward ar. other strategies to reduce antibiotic selective pressure include the use of bacteriophages (a revitalized strategy in recent years) (viertel et al., ; forti et al., ) , not only in clinical settings, but also in natural ecosystems (zhao et al., b) , as well as the use of biodegradable antibiotics (chin et al., ) or adsorbents, able to reduce selective pressure on commensal microbiome (de gunzburg et al., . besides reducing the chances of selecting arbs, the use of antibiotics adsorbents may preserve the microbiomes, reducing the risks of infections (chapman et al., ) . importantly, the procedures for removing antibiotics should not be limited to clinical settings, but their implementation in wastewater treatment plants would reduce selection of ar in non-clinical ecosystems (tian et al., ) . concerning the development of new antimicrobials (hunter, ) , while there is a basic economic issue related to the incentives to pharmaceutical companies (sciarretta et al., ; theuretzbacher et al., ) , the focus is on the possibility of developing novel compounds with low capacity for selecting ar (ling et al., ; chin et al., ) . for this purpose, multitarget (li et al., ) or antiresistance drugs, such as membrane microdomain disassemblers (garcia-fernandez et al., ) , are also promising. furthermore, antimicrobial peptides, with a dual role as immunomodulators and antimicrobials, may also help fight infections (hancock et al., ) . in fact, some works figure | local and global intervention strategies to tackle ar and knowledge gaps that could help improve existing ones. most interventions for reducing antibiotic resistance are based on impairing the selection of arbs/args, which is just the first event in ar spread. our main goal, as for any other infectious disease, figure | continued would be reducing transmission. this does not mean that selective pressure is not relevant for transmission. indeed, without positive selection, hgt events are not fixed, allowing the enrichment of some args that are consequently more prone to diversification, both because they are more abundant and more frequently subjected to selection (davies, ; martinez, a,b; salverda et al., ) and because they can explore different landscapes when present as merodiploids in multicopy plasmids (rodriguez-beltran et al., ) . therefore, reducing the selective pressure, either due to antibiotics or by other coselecting agents as heavy metals, still stands as a major intervention against ar emergence and transmission. to address this issue, we need to know more on the amount of pollutants, their selective concentrations, and their mechanisms of coselection and cross-selection in different ecosystems. this is a general example illustrating the gaps in knowledge in the ar field that need to be filled as well as strategies that may help in tackling this problem. the figure includes several other examples of the gaps of knowledge (red) that require further studies and the interventions (blue) that may help to tackle ar. have shown that arb frequently present collateral sensitivity to antimicrobial peptides (lázár et al., ) and that, importantly, some antimicrobial peptides present limited resistance or crossresistance (kintses et al., ; spohn et al., ) . from a conservative point of view, based on the use of the drugs we already have, it would be desirable to fight ar using evolution-based strategies for developing new drugs or treatment strategies. regarding this, the exploitation of the evolutionary trade-offs associated with the acquisition of ar, as collateral sensitivity, could allow the rational design of treatments based on the alternation or the combination of pairs of drugs (imamovic and sommer, ; gonzales et al., ; barbosa et al., ; imamovic et al., ) . in addition to interventions that reduce the selective pressure of antibiotics or that implement new therapeutic approaches, reducing transmission is also relevant to fight infections. the development of drugs or conditions (as certain wastewater treatments) able to reduce mutagenesis or to inhibit plasmid conjugation may also help in reducing the spread of resistance (thi et al., ; alam et al., ; lin et al., ; lopatkin et al., ; valencia et al., ; kudo et al., ) . besides specific drugs to reduce the dissemination of the genetic elements involved in ar, socioeconomic interventions to break the bridges that allow transmission between individuals and, most importantly (and less addressed), between resistance entities (hernando-amado et al., ) are needed (figure ) . more efficient animal management, not only allowing less antibiotics use but also reducing animal crowding (and hence ar transmission), as well as improved sanitation procedures, including the universalization of water treatment, will certainly help in this task (berendonk et al., ; manaia, ; hernando-amado et al., ) . notably, wastewater treatment plants are usually communal facilities where the residues of the total population of a city are treated. hospitals are the hotspots of ar in a city; hence, on-site hospital (and eventually onfarm) wastewater treatment may help to reduce the pollution of communal wastewater by antibiotics and arbs (cahill et al., ; paulus et al., ) , hence reducing ar transmission. concerning trade of goods, it is relevant to remark that, although there are strict regulations to control the entrance of animals or plants from sites with zoonotic of plant epidemic diseases (brown and bevins, ) , there are no regulations on the exchange of goods from geographic regions with a high ar prevalence, a feature that might be taken into consideration for reducing the worldwide spread of ar. once arbs are selected and disseminated, interventions based on the ecological and evolutionary (eco-evo) aspects of ar lehtinen et al., ) should be applied to restore (and select for) susceptibility of bacterial populations, as well as to preserve drug-susceptible microbiomes in humans and in animals . eco-evo strategies include the development of drugs specifically targeting arbs. for that, drugs activated by mechanisms of resistance, vaccines targeting high-risk disseminating resistance clones or the resistance mechanisms themselves (kim et al., ; ni et al., ) , or drugs targeting metabolic paths that can be specifically modified in arbs ) might be useful. the use of bacteriovores such as bdellovibrio to eliminate pathogens without the need for antibiotics has been proposed; although its utility for treating infections is debatable, it might be useful in natural ecosystems (shatzkes et al., ) . more recent work suggests that some earthworms may favor the degradation of antibiotics and the elimination of arbs (wikler, ) , a feature that might be in agreement with the finding that arbs are less virulent (and hence might be specifically eliminated when the worm is present) in a caenorhabditis elegans virulence model ruiz-diez et al., ; paulander et al., ; olivares et al., ) . however, the information on the potential use of worms for reducing ar in the field is still preliminary and requires further confirmation. noteworthy, ar is less prone to be acquired by complex microbiomes (mahnert et al., ; wood, ) , a feature that supports the possibility of interventions on the microbiota to reduce ar. among them, fecal transplantation (chapman et al., ; pamer, ) or the use of probiotics able to outcompete arbs (keith and pamer, ) has been proposed as strategies for recovering susceptible microbiomes. the recent crisis of covid- (garrett, ) resembles the pandemic expansion of args and clearly shows that pandemic outbreaks cannot be solved by just applying local solutions. further, unless all population is controlled, and comprehensive public-health protocols are applied to the bulk of the population, such global pandemics will be hardly controlled. the case of covid- is rather peculiar, because we are dealing with a novel virus. very strict interventions have been applied, mainly trying to control something that is a novel, unknown, disease; we have been learning along the pandemic and still ignore what will come further. ar is already a very well-known pandemic affecting humans, animals, and natural ecosystems (anderson, ; verhoef, ) . in this case, we have tools that might predict the outcome, and likely because the degree of uncertainty is lower than in the case of covid- , we have not applied clear, common, and comprehensive procedures to reduce the spread of ar. it is true that we know the evolution of antibiotics consumption and ar prevalence in several countries, and also interventions, mostly based on social norms, have been applied. social norms have reduced the unnecessary prescription of antibiotics, or pharmacy sales without prescription, and the use of antibiotics for fattening animals has been banned in several countries, being still allowed in several others. nevertheless, these actions are not general, and more aggressive, global actions are still needed. coming back to the covid- example, while the aim of health services worldwide is to detect any possible source of sars-cov- , surveillance of infections (eventually by arbs) is not universal. in other words, it does not apply to all citizens in all countries. the reasons can be just political such as the inclusion of immigrants in public health services (scotto et al., ) or the consequence of limited financial resources and technical capacity that countries such as those belonging to the lmic category can face (gandra et al., ) . the problem is not only on citizens, because different non-human reservoirs, such as wastewater, drinking water, or freshwater, may jointly contribute to ar dissemination (hendriksen et al., ) . in this regard, it is important to highlight that low quality of water is regularly associated to poverty. universalization of health services, sanitization, access to clean water, and in general reduction of poverty are relevant step-forward elements for reduction of the burden of infectious diseases in general and of ar in particular. the time has come to tackle ar, and this cannot be done just by taking actions at the individual or even country level, but by taking convergent actions across the globe. as stated by john donne ( ) in his poem, "no man is an island, " written after his recovery from an infectious disease (likely typhus): "no man is an iland, intire of itselfe; every man is a peece of the continent, a part of the maine; if a clod bee washed away by the sea, europe is the lesse, as well as if a promontorie were, as well as if a manor of thy friends or of thine owne were; any mans death diminishes me, because i am involved in mankinde; and therefore never send to know for whom the bell tolls; it tolls for thee." this reflection on how infectious diseases in general should be faced by the society was published at , but the idea behind still applies nowadays, especially for ar. all authors have contributed to the concept of the review and in its writing. jm was supported by grants from the instituto de salud carlos iii [spanish network for research on infectious diseases (rd / / )], from the spanish ministry of economy and competitivity (bio - -r) and from the autonomous community of madrid (b /bmd- ). work in tc and fb laboratory was supported by grants funded by the joint programming initiative in antimicrobial resistance (jpiamr third call, starcs, jpiamr -ac / ), the instituto de salud carlos iii of spain/ministry of economy and competitiveness and the european development regional fund "a way to achieve europe" (erdf) for co-founding the spanish r&d national plan estatal de i + d + i - (pi / ), ciberesp (ciber in epidemiology and public health; cb / / ), the regional government of madrid (ingemics-b /bmd- ) and the fundación ramón areces. the funders did not have any role neither in the design, nor in the writing of the current review. association between decreased susceptibility to a new antibiotic for 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ecosystems date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: mdiwzvc covid- has changed our lives forever. the world we knew until now has been transformed and nowadays we live in a completely new scenario in a perpetual restructuring transition, in which the way we live, relate, and communicate with others has been altered permanently. within this context, risk communication is playing a decisive role when informing, transmitting, and channeling the flow of information in society. covid- has posed a real pandemic risk management challenge in terms of impact, preparedness, response, and mitigation by governments, health organizations, non-governmental organizations (ngos), mass media, and stakeholders. in this study, we monitored the digital ecosystems during march and april , and we obtained a sample of , communications through the analysis of apis and web scraping techniques. this study examines how social media has affected risk communication in uncertain contexts and its impact on the emotions and sentiments derived from the semantic analysis in spanish society during the covid- pandemic. the outbreak of the coronavirus disease was first reported by the wuhan municipal health and safety commission (hubei province, china) on december . one month later, the emergency committee of the international health regulations [ ] declared the new coronavirus outbreak as a public health emergency of international importance (phei) at its meeting on january [ ] . five months after the official announcement, the virus has infected more than , , people worldwide and killed around , people [ ], bringing catastrophic consequences for society [ ] , completely collapsing health systems in different countries [ ] and generating a strong economic recession worldwide [ ] . throughout the history of mankind, societies have been faced with crises of various kinds and of very diverse natures, such as civil conflicts, financial crises, crises caused by the management and export of energy resources or emergencies caused by the impact of diseases and epidemics, among others [ ] . it is only necessary to recall some of the events of the past th century to be able to appreciate how figure shows the trend in reported cases of covid- , deaths, and recoveries patients between february and may . it is verified that the highest level of cases by coronavirus was on march and deceased people on april . after these days, the curve of new infections and deaths trended downward and recovered people were increasing. face masks were a problem, especially at the beginning of the pandemic. initially, they were not available to the general population, so they were only used for those most at risk of infection, such as health care, security forces, and the military. the government of spain was responsible for the purchase and distribution of face masks to the autonomous communities. figure shows the distribution of face masks carried out by the government between march and may . madrid and catalonia, with the highest number of infections from covid- , were where most face masks were distributed. face masks were a problem, especially at the beginning of the pandemic. initially, they were not available to the general population, so they were only used for those most at risk of infection, such as health care, security forces, and the military. the government of spain was responsible for the purchase and distribution of face masks to the autonomous communities. figure shows the distribution of face masks carried out by the government between march and may. madrid and catalonia, with the highest number of infections from covid- , were where most face masks were distributed. int. j. environ. res. public health , , x of figure shows the trend in reported cases of covid- , deaths, and recoveries patients between february and may . it is verified that the highest level of cases by coronavirus was on march and deceased people on april . after these days, the curve of new infections and deaths trended downward and recovered people were increasing. face masks were a problem, especially at the beginning of the pandemic. initially, they were not available to the general population, so they were only used for those most at risk of infection, such as health care, security forces, and the military. the government of spain was responsible for the purchase and distribution of face masks to the autonomous communities. figure shows the distribution of face masks carried out by the government between march and may . madrid and catalonia, with the highest number of infections from covid- , were where most face masks were distributed. this research work represents a pioneering challenge in the field of risk communication research. during the months of march and april , various digital ecosystems were analyzed, and a sample of , communications was obtained through the analysis of apis and web scraping techniques. the study analyzes, through social media, how risk communication management has masks that the spanish government has distributed to each autonomous community from march to may [ ] . the communication makes explicit reference to the covid- pandemic in spain. the communication is public and can be viewed without the need for a subscription to the data source or explicit permission from the sender of the communication. the author's reported age, when available, was over years old as of the start of the end of the study ( april ). the communication is written in spanish. on the other hand, the exclusion criteria were: • the communication does not come from an advertising campaign. the communication has not been generated by automatic procedural methods (bots, fake posts, among others). one of the most usual problems that we must deal with when using information from digital ecosystems is detecting spammers, fake information generated by bots, which tries to influence or modify the perceived opinion on existing information. to detect and discard this type of information we have implemented different types of algorithms based on support vector machine (svm) techniques which can detect the patterns of this kind of communications, such as the age of the account (in days), the number of comments from the account, follower/following ratio, and the ratio of messages containing urls. to prevent the effect of spammers, in this work we implemented and applied filters previously defined and tested in other scientific works [ , ] . the emotion information from each communication was extracted employing the natural language analysis tools provided by the ibm watson analytics service [ ] . the emotional intensity was measured in a to scale, where represents the complete absence of this emotion; and represents an absolute high intensity of the emotion. in total, this study measured the emotional intensity of four primal emotions-anger, fear, disgust, and sadness. to detect and measure the primary emotions in this study we used the services provided by the ibm watson system. watson is a cognitive computing platform that combines a deepqa architecture, with ai algorithms and big data to solve questions in the domain of natural language. this platform offers a wide range of services including discovery, knowledge studio, language translator, natural language classifier/understanding, and personality insights among others. watson has an overall precision of % in natural language processing and has been widely compared with other systems, as well as with humans, and in both cases, it has obtained very satisfactory results. for this reason, this system has been widely used in different scientific works where it has further proved its capabilities on natural language processing (nlp) tasks [ ] [ ] [ ] [ ] [ ] [ ] . in this work, we made use of the natural language understanding service from the ibm watson platform which, given an input text, provides an analysis of syntactic characteristics as well as information on categories, concepts, emotions, entities, keywords, metadata, relationships, and semantic roles. the reliability of the resultant emotion information was tested using the interval majority aggregation operator (isma-owa) [ ] , which is designed for decision making in social media with consistent data, leveraged by the combination of computational intelligence and big data techniques [ ] . to obtain representative results, when analyzing with information extracted from digital ecosystems, it is important to ensure a correct representation of such information and its quality. when people express opinions in communications, they do not do so in numerical value with a fixed scale, they use natural language expressions such as "this is great" or "this is not so good", so we employed the intervalar representation proposed in [ , ] instead of a numerical scale. the main advantage of this approach is that intervals represent the information within communication in a way that is more similar to the way people express themselves in digital ecosystems, thus reducing the loss of information associated with forcing linguistic data to a hard-numerical scale. furthermore, regarding information quality, an important aspect that we must consider when assessing the validity of this information is to ensure that such information has been expressed with knowledge of the topic at hand and not at random. another advantage of the usage of an intervalar representation of digital ecosystem data is the availability of consistency indices that can be applied to the matrices obtained from communications to detect inconsistencies derived from uninformed opinions. for this purpose, in this work, we employed the ci+ index defined in [ ] . the frequency of the words comprising the sample of communications was calculated using a natural language processing algorithm implemented in python , using the natural language toolkit (nltk) [ ] . moreover, the emotion polarity (positive or negative) was measured using a multilayer perceptron model, trained to classify the emotional weight of written communications [ , ] . the python nltk library is an open-source programming library for working with natural language data which incorporate functions that allow for the determination of the frequency of words in a text while discarding stop-words, that is words that are very common to a language but do not convey any significant information such as "the", "a" and "very". furthermore, the nltk library serves as a pre-processing tool to use other artificial intelligence tools such as artificial neural networks such as the multi-layered perceptron that we used in this work to detect the polarity of communications. a multi-layered perceptron (mlp) is a widely used artificial neural network architecture that utilizes a technique known as supervised training to learn how to differentiate data that is not linearly separable. in this case, we trained our mpl with a set of communications created by the spanish society for natural language processing (sepln) which contains over , natural language texts tagged with the polarity of each communication, that is, each communication contained metadata that indicated if the message was positive or negative. there are other techniques for natural language sentiment analysis, such as naïve bayes, or support vector machines, but we opted for the mlp approach since it can learn complex relationships and it does not enforce any sort of constraint concerning the input data [ ] . to further improve the qualitative analysis, the above-mentioned information regarding the volume of communications, the frequency of words and the emotion expressed by each communication was contrasted to determine the information pathways between mass media, government, political parties, employers' confederation, non-governmental organizations (ngos), trade unions, the world health organization (who), among others. this approach provides a graphical representation of the information fluxes about the covid- disease in spain. for the analysis of the messages emitted by the spanish government, a content analysis of all press releases during the period of study was carried out. messages were classified as positive, neutral, or negative by selecting the most significant words from them. the frequency of repetition of these words was another objective of this content analysis. the result has been shown through a word cloud representative of the emotions and feelings expressed by the government in its press releases. the analysis of content permits inferences to be reproduced based on specific characteristics identified in the messages [ , ] . this type of analysis allows for the discovery of tendencies and the revelation of differences in content communication. likewise, this allows the comparison of messages and means of communication, and the identification of intentions, appeals. to this effect, value and frequency analysis were used [ ] . since the beginning of the pandemic, the structure organized by the government has involved relations between the spanish government (the health alert coordination center, which is part of the ministry of health) and the governments of the autonomous communities, the national epidemiology center, the national microbiology center and the international organization's world health organization (who), the european disease control center and the european commission [ ] . to raise awareness and inform public opinion, the spanish government designed a communication strategy articulated in four actions that had the use of the mass media as channels of transmission of covid- information as a main objective: (a) weekly appearances of the president of the government. (b) daily press conferences chaired jointly by the following ministers: minister of health, who is responsible for the state of alarm decreed in the country; minister of defense, who is responsible for the military forces; minister of the interior, who is responsible for the state security forces and minister of transport. all of them were accompanied by experts in each of the areas. the ministers sent out a political message and the experts went into detail about the actions being taken. with a press conference format, online questions from the main spanish and foreign media were admitted. however, this format underwent the first modification after the second week being responsible for the press conferences the so-called "technical committee for monitoring the coronavirus pandemic in spain" consisting only of experts of the different ministries. on april, there was a new restructuring of the press conferences, leaving only the director of the health alert and emergency coordination centre of the ministry of health as the health expert. this last change is censored by the communications media. (c) press release. after the appearance at a press conference, the communication department of the ministry of health sent a press release to all the media. (d) interviews with ministers. another of the government's actions was to make its cabinet available to the media for interviews. to reinforce the previous actions, on march , the state government launched the advertising campaign #estevirusloparamosunidos. this campaign is adapted for television, press, radio, outdoor advertising, and social networks. in a public health crisis like the one spain is experiencing, a transparent and empathetic communication style would generate citizen confidence and would be more effective if politicians and experts unanimously tried to stimulate the population to take a positive stance towards the pandemic and the health and economic alert measures imposed by the government. although the generation of trust must be essential in a crisis, the analysis carried out shows the public's distrust of scientific experts and government representatives for a variety of reasons such as access to conflicting sources of information, contradictions in scientific reasoning, changes in decision-making and, above all, political confrontations. trust and credibility, demonstrated through empathy, experience, honesty, and transparency, are essential elements of public health crisis communication [ ] . figure analyzes the messages transmitted by the ministry of health in its press releases between march and april. in green, the positive messages were determined, in black the neutral ones and in red the negative ones. the word size indicates the frequency of repetition in the press releases. as can be seen in the word cloud, the negative word "covid" is the most used by the government in its communications. this is followed at a distance by "coronavirus" and "health crisis" with a dark red color that indicates their use in negative messages, but also in neutral tones. "social networks" is a neutral term used mainly to explain the social network campaigns implemented by the government. it is followed by "patients" and "nursing home". however, the most remarkable thing about this word cloud is its words in the green. the communication made by the communication office of the ministry of health has always wanted to give a positive view in all their messages, with "government" as the most used word, followed by "face masks", "ministry of health" or "test". this could indicate a lack of transparency about the situation the country was going through. none of these press releases refer to either the infected or the dead. attempts are made to give a protagonist role, at times, to all the actions carried out by the government. in spain, the decreed state of alarm requires the total confinement of the population. royal decree-law / , of march [ ] , establishes the minimum essential services of first necessity such as all those necessary for the supply of food to the population. the minimum distance was made to be one and a half meters. except for these cases, the rest of the population must carry out their work by teleworking, and if this work is not possible, the government approved royal decree-law / of march on extraordinary urgent measures to cope with the economic and social impact of covid- [ ] , which regulates emergency procedures to combat the economic and social impact of the pandemic, denominated as the temporary employment regulation file (terf). the number of workers affected by the terf was two million on april [ ] . the high number of terf requests blocks the administration from responding to the citizens with a decrease of the collection of these aids and the decapitalization of these workers in some cases without the possibility of paying the rents of their houses or simply buying the necessary food for the family. non-governmental organizations and food banks have a crucial role to supply the neediest in the population. during confinement, the media are not left out. their workers follow their work from their homes. on televisions, these measures cause programs to be suspended and replaced by new programming offering coronavirus specials. these programs have a structure of news, interviews with experts or politicians, discussion programs or talk shows where covid- and the situation that citizens are experiencing are analyzed. due to the uncertainty of the situation and the isolation in their homes, citizens are consuming more television. thus, the month of march and later april became the months with the highest television audience in spanish history. march data show an average consumption of min per person per day ( h and min). the average number of people who had watched tv for at least one minute a day was min ( h and min) [ ] . the progression in the television audience continued in the month of april with numbers never seen in the conventional spanish television with min ( h and min) and min ( h and min) respectively. in addition to television coverage, . million spaniards consumed this medium daily, representing . % of the population [ ] . the serious effects on the economy caused by the crisis determine that new actors acquire an active role in communication by modifying the initial panorama organized by the government. political parties, the confederation of employers and trade unions are configured as sources of information. these new stakeholders also offer interviews to the communication media, organize press conferences, and finally communicate with citizens directly through social media (see figure ) . therefore, the stakeholder structure created by the government is increased by other social actors who have their own opinion on the management of the pandemic. all of them have in common the use of the media to convey their messages to the citizens, converting these media as the main interlocutors with the population. the high consumption of television makes it the main means of information used by citizens. public and private televisions in spain broadcast the press conferences of the different stakeholders and the appearances of the president of the government. this is referred to in figure as "news". the different ideological tendencies of the television channels in spain mean that their interview programs with experts and television debates do not follow a single argument in support of the government's management. these messages feature contradictory opinions that the media convey to the public as interviews, discussion programs, and talk shows, which increase uncertainty among citizens (figure ). in a public health crisis like the one spain is experiencing, a transparent and empathetic communication style would generate citizen confidence and would be more effective if politicians and experts unanimously tried to stimulate the population to take a positive stance towards the pandemic and the health and economic alert measures imposed by the government. although the generation of trust must be essential in a crisis, the analysis carried out shows the public's distrust of scientific experts and government representatives for a variety of reasons such as access to conflicting sources of information, contradictions in scientific reasoning, changes in decision-making and, above all, political confrontations. trust and credibility, demonstrated through empathy, experience, honesty, and transparency, are essential elements of public health crisis communication [ ] . figure analyzes the messages transmitted by the ministry of health in its press releases between march and april. in green, the positive messages were determined, in black the neutral ones and in red the negative ones. the word size indicates the frequency of repetition in the press releases. as can be seen in the word cloud, the negative word "covid" is the most used by the government in its communications. this is followed at a distance by "coronavirus" and "health crisis" with a dark red color that indicates their use in negative messages, but also in neutral tones. "social networks" is a neutral term used mainly to explain the social network campaigns implemented by the government. it is followed by "patients" and "nursing home". however, the most remarkable thing about this word cloud is its words in the green. the communication made by the communication office of the ministry of health has always wanted to give a positive view in all their messages, with "government" as the most used word, followed by "face masks", "ministry of health" or "test". this could indicate a lack of transparency about the situation the country was going through. none of these press releases refer to either the infected or the dead. attempts are made to give a protagonist role, at times, to all the actions carried out by the government. in contrast, figure shows the results of the , listings made on social media between the same months and shows the feelings and emotions of the population. on this occasion, the word "cases" is the most representative that reflects the number of infections suffered in the country. it is followed by the word "crisis", which represents the public health crisis but also the economic one. the terms "covid" and "coronavirus" are strongly represented, as well as "spain" and "world" which represent the concern of the population in the face of a pandemic of this magnitude. "casualties" is another of the most significant words and is indicative of all those people who have benefited from the terf and who have not yet received the promised aid from the government. the positive messages sent by the government and its experts are counterbalanced by the volume of opinion generated by the media and especially the generalist televisions. some reasons include political parties' criticism of the government's management, contradictions of the experts, the constant increase of infected and dead, spain being among the most affected countries, the state of confinement suffered by society not always in the best conditions, the anxiety of not having financial resources, the population's insecurity in the face of a public health crisis with global effects that are caused by millions of infected people and hundreds of thousands of deaths in the world. all these reasons generate negative feelings and emotions, causing uncertainty and fear among citizens. digital ecosystems reflect this trend in a word cloud with a markedly negative character ( figure ). in contrast, figure shows the results of the , listings made on social media between the same months and shows the feelings and emotions of the population. on this occasion, the word "cases" is the most representative that reflects the number of infections suffered in the country. it is followed by the word "crisis", which represents the public health crisis but also the economic one. the terms "covid" and "coronavirus" are strongly represented, as well as "spain" and "world" which represent the concern of the population in the face of a pandemic of this magnitude. "casualties" is another of the most significant words and is indicative of all those people who have benefited from the terf and who have not yet received the promised aid from the government. the positive messages sent by the government and its experts are counterbalanced by the volume of opinion generated by the media and especially the generalist televisions. the communications that have the greatest impact on four of the main emotions of the population-fear, sadness, disgust, and anger-are presented. the study has allowed for the some reasons include political parties' criticism of the government's management, contradictions of the experts, the constant increase of infected and dead, spain being among the most affected countries, the state of confinement suffered by society not always in the best conditions, the anxiety of not having financial resources, the population's insecurity in the face of a public health crisis with global effects that are caused by millions of infected people and hundreds of thousands of deaths in the world. all these reasons generate negative feelings and emotions, causing uncertainty and fear among citizens. digital ecosystems reflect this trend in a word cloud with a markedly negative character ( figure ). the communications that have the greatest impact on four of the main emotions of the population-fear, sadness, disgust, and anger-are presented. the study has allowed for the determination of the reaction of the population concerning the covid- pandemic and the crisis communication carried out by the government, determining the themes and the feelings of the communications associated with the crisis communication. to this end, the emotion graph corresponding to the period of study is first determined, determining the peaks of emotion that are significant, and those news patterns that generate greater presence and reach in digital ecosystems. secondly, the topics that have most influenced these emotions are analyzed and the patterns that generate them are concluded. figure shows the evolution of the disgust emotion during the study period, where nine peaks can be distinguished where the emotion shows a significant increase. in table , the communications that had the greatest impact on this increase are analyzed in chronological order from march to april . from these communications, the management of the pandemic is the general theme that most impacts the emotion treated. aspects such as: blaming the pandemic on groups that can be grouped by religion, sex, use of the security forces to censor the population's opinion; lack of care for weak sectors such as the elderly; and the purchase of health material are the conversations that predominate in digital ecosystems. • the religious community is eager for the ministry of health to "point them out" because it leaves them in a "state of defenselessness" and they demand an apology. the evangelicals see it as "very serious" that the ministry of health points to a religious group as a possible focus. march • a collapse in funeral homes and mortuaries. • spanish health workers are the worst protected. the government is withholding health materials from autonomous communities. the risk of coronavirus is due to gender roles. april • purchase of masks from opaque companies. the government forces companies to provide workers with protective measures when they cannot buy material. the government spends money on protecting cars when there is a lack of material in hospitals and nursing homes. april • government members fail to comply with confinement. • government management to protect against future malpractice claims. the political use of pandemic management. use of the guardia civil to minimize the anti-government climate. april • government control of the media. higher payment for medical equipment by the government. lack of material for workers and they are forced to return to work. the hiring of companies without guarantees to obtain sanitary material. april • use of the police and confinement to control complaints from the population. the government admits that it lies about the number of tests performed. false count in the number of deaths. finally, in figure , the most relevant topics and their impact value on the emotion of disgust are shown. this shows how the management of masks, censorship in the news, and the transmission of the virus in general and especially in groups of elderly people, predominate in this emotion. figure shows the evolution of the fear emotion during the study period, where five peaks can be distinguished, where the emotion shows a sustained decrease over time. in table , the communications that have had the greatest impact on this temporal progression are analyzed in chronological order from march to april . of these communications, the rapid growth of the pandemic in spain, the overwhelming social security system, and the economic collapse caused by the covid- pandemic are the general themes that have the greatest impact on the emotions addressed. aspects such as border closures, death forecasts, job losses, defective health material, the spanish government being overwhelmed, and deaths in residences are the conversations that predominate in digital ecosystems. finally, figure shows the most relevant issues and their impact value on the emotion fear. this shows how interest in the state of alarm, the transmission of the virus, emergency health material, and deaths of family members predominate in this emotion. figure shows the evolution of the anger emotion during the study period, where eight peaks can be distinguished where the emotion shows sustained growth over time. in table , the communications that had the greatest impact on this temporal progression are analyzed in chronological order from march to april . from these communications, it can be seen that the loss of employment due to lack of foresight, the delay in activating the health alert, and the opacity in the acquisition of health material by the spanish government during the crisis by covid- were the driving themes in this case. aspects such as disinformation for de-escalation, the collapse of the health system, the dubious data on the number of infected and dead people, and the control of the media proposed by members of the spanish government are some of the conversations that predominate in digital ecosystems. finally, figure shows the most relevant topics and their impact value on the anger emotion. this shows how the interest in deaths by a coronavirus, the resources to cure the virus, the diagnosed cases, and the rate of infected, predominate in this emotion. this shows that the lack of prevision predominates in this emotion. figure . the themes related to covid- and anger emotion that have impacted most along with its impact value. figure shows the evolution of the sadness emotion during the study period, where eight peaks can be distinguished where the emotion shows sustained growth in time. in table , the communications that had the greatest impact on this temporal progression are analyzed in chronological order from march to april . of these communications, censorship during covid- , die of coronavirus, coronavirus patients, infection of coronavirus, and the delay in the incorporation to the labor activity are the general themes that have the greatest impact on the emotion dealt with. aspects such as political interests, entities that the security of the population due to the virus, sale of necessary material by the covid- pandemic to foreign countries when it is necessary for spain, healthcare workers exposed to infection by defective health care material are some of the conversations that predominate in digital ecosystems. finally, figure shows the most relevant topics and their impact value on sadness's emotion. this shows how the interest in deaths by covid- , patients by covid- , the elderly, and infected workers, predominate in this emotion. as shown in figure , the highest presence of the term covid- occurred in the early stages of the pandemic, reaching its highest value on the date when the government of spain announced that it would implement the state of alarm and confinement of the population. from that date onwards, there is a downward trend in the use of this term, until april, when an extension of the state of alarm is announced. the spread of pandemics causes uncertainty and fear among the population. this type of crisis, by not adjusting to specific limits, makes risk communication more critical when designing effective strategies [ , ] . effective risk communication means that all messages can be presented and shared with the population in a transparent, credible, and easily understood communication process. its main objective is to reduce the knowledge gap between the issuers of information and its recipients to adjust public behavior to proactively address risk [ , ] . the essential elements for reducing risk and avoiding panic among the population are rapid action by public health organizations and truthful and honest information from governments [ ] . even though rodin et al. [ ] indicate that in the case of a crisis in public health, stakeholders are structured in international and national public health organizations, national governments, nongovernmental organizations, the media, and citizens, the serious situation experienced in spain has led to new actors taking on a decisive role in communication, modifying the organizational structure originally designed by the government. therefore, the little or no dialogue between the government and the social actors that make up the map of the main publics involved in the covid- crisis with different points of view in the face of the pandemic leads to the conclusion that the structure of the stakeholders involved does not determine singular, clear and efficient communication that gives confidence to society. the analysis of the government's communication management shows that the messages emitted, mostly with a positive tone, have been offset by a flow of information from other actors in disagreement with government policies. these are mainly channeled by the media and especially the generalist televisions. in spain, three out of four citizens have used generalist television to keep themselves informed during the pandemic. television is also the medium most used by spaniards to seek out different expert opinions. finally, seven out of ten spaniards say that the diversity of journalists, approaches, and news items on generalist television help them form their own opinions [ ] . this information, sometimes contradictory, that reaches the population makes uncertainty and panic be perceived by the citizens through digital ecosystems. there are significant differences between the feelings and emotions of the public about covid- analyzed in this study and the tone of the risk communication carried out by the spanish government and the committee of experts represented in figure . risk communication has very close links to the behavioral health issues that affect tens of millions of people. fear and anxiety about a new disease and what could happen can be overwhelming and cause strong emotions in the population. through the monitoring of the emotions and the general sentiment of the people across social media about the covid- pandemic reveals that: during this time, the use of the term covid- followed a decreasing tendency, motivated by the emotions that the population experienced. if at the beginning, the great concern was the virus, the management carried out by the government, the deaths, the social actions, all caused a change in the terms used in the digital ecosystems, with the virus being a secondary problem about the subjects that influence the emotions. the spread of pandemics causes uncertainty and fear among the population. this type of crisis, by not adjusting to specific limits, makes risk communication more critical when designing effective strategies [ , ] . effective risk communication means that all messages can be presented and shared with the population in a transparent, credible, and easily understood communication process. its main objective is to reduce the knowledge gap between the issuers of information and its recipients to adjust public behavior to proactively address risk [ , ] . the essential elements for reducing risk and avoiding panic among the population are rapid action by public health organizations and truthful and honest information from governments [ ] . even though rodin et al. [ ] indicate that in the case of a crisis in public health, stakeholders are structured in international and national public health organizations, national governments, non-governmental organizations, the media, and citizens, the serious situation experienced in spain has led to new actors taking on a decisive role in communication, modifying the organizational structure originally designed by the government. therefore, the little or no dialogue between the government and the social actors that make up the map of the main publics involved in the covid- crisis with different points of view in the face of the pandemic leads to the conclusion that the structure of the stakeholders involved does not determine singular, clear and efficient communication that gives confidence to society. the analysis of the government's communication management shows that the messages emitted, mostly with a positive tone, have been offset by a flow of information from other actors in disagreement with government policies. these are mainly channeled by the media and especially the generalist televisions. in spain, three out of four citizens have used generalist television to keep themselves informed during the pandemic. television is also the medium most used by spaniards to seek out different expert opinions. finally, seven out of ten spaniards say that the diversity of journalists, approaches, and news items on generalist television help them form their own opinions [ ] . this information, sometimes contradictory, that reaches the population makes uncertainty and panic be perceived by the citizens through digital ecosystems. there are significant differences between the feelings and emotions of the public about covid- analyzed in this study and the tone of the risk communication carried out by the spanish government and the committee of experts represented in figure . risk communication has very close links to the behavioral health issues that affect tens of millions of people. fear and anxiety about a new disease and what could happen can be overwhelming and cause strong emotions in the population. through the monitoring of the emotions and the general sentiment of the people across social media about the covid- pandemic reveals that: research shows that the current covid- pandemic is creating an added strain on our emotional well-being. topics and themes connected to covid- include management, social collaboration, death, safeguarding, and lack of foresight. those are strongly related to health and finances, uncertainty about the length of the quarantine, anger over the loss of control, fear of death, illness, loss of employment, economic instability, loss of loved ones, discontent with the spanish government, transparency, a sense of loneliness and, ultimately, fear of the unknown. research results also demonstrate a lot of mixed feelings. it is observed that the same news, information or media communication generated peaks in different emotions, indicating that they are very mixed between sadness, disgust, anger, and fear. presence analysis reveals that the term covid- received the highest presence during the early stages of the pandemic, reaching its highest value on the date when the government of spain announced that it would implement the state of alarm and confinement of the population. from that date onwards, there is a downward trend in the use of the term covid- . during this time, the use of the term covid- has followed a decreasing tendency, motivated by the emotions that the population has experienced. initially, as reflected in the study, only the virus (term covid) was of interest, and later, the consequences and direct impact of the virus on daily life. statement on the second meeting of the international health regulations ( ) emergency committee regarding the outbreak of novel coronavirus ( -ncov); convened by the w.d.-g. under the i.h.; world health organization the outbreak of coronavirus disease (covid- )-an emerging global health threat knowledge system analysis on emergency management of public health emergencies the global economic impact of covid- : a summary of research the oxford handbook of world history a multidimensional model of public health approaches against covid- cartographies of time: a history of the timeline ebola on instagram and twitter: how health organizations address the health crisis in their social media engagement the great convergence: information technology and the new globalization social media use in the united states: implications for health communication what does the public know about ebola? 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philos the public and effective risk communication effective risk communication; routledge: london, uk effective risk communication disentangling rhetorical subarenas of public health crisis communication: a study of the - ebola outbreak in the news media and social media in sweden sobre la percepción social de la televisión en abierto the authors declare no conflict of interest. key: cord- - p k it authors: kaplan, bruce; kahn, laura h; monath, thomas p; woodall, jack title: 'one health' and parasitology date: - - journal: parasit vectors doi: . / - - - sha: doc_id: cord_uid: p k it nan one health is a concept that proposes that a paradigm shift in approaching diseases of humans and animals is essential to meet the challenges of the st century. human and veterinary medicine, as well as all other scientific-health related disciplines, must begin forging coequal, all-inclusive collaborations. physicians, veterinarians, other health scientists, and their respective educational institutions, organizations and health agencies must work together. in the past, this approach has resulted in more rapid, efficacious, synergistic achievements in advancing health. unfortunately, such an approach has been relatively rare during the th century. since ancient times the concept that animal health and the environment influence human health has been around. one health began in the late th and th centuries with physician leaders in medicine like rudolf virchow, known as the "father of comparative medicine, cellular pathology, and veterinary pathology" and william osler, called the "father of modern medicine." they embraced the concept that human and animal health were inextricably linked. virchow conducted experimental animal studies on trichinella spiralis in porcine muscular tissue and cysticercosis and tuberculosis in cattle; he coined the term "zoonosis" and stated, "between animal and human medicine there are no dividing lines -nor should there be." osler, who studied in berlin with, and was influenced by virchow, helped promote "one health" as he taught veterinary pathology at montreal veterinary college, and established veterinary pathology as an academic discipline in north america. the physician and veterinarian research team of theobald smith, and f. l. kilborne, discovered the etiology of cattle fever, babesia bigemina, and that it was transmitted by tick vectors, in . their important work helped set the stage for the discovery of the mosquito vector transmission of yellow fever by walter reed and colleagues. in october , the virus causing ebola hemorrhagic fever was identified and named by the u.s. centers for disease control and prevention (cdc) physician virologist, karl johnson, in collaboration with veterinarian pathologist-virologist, fred murphy. they collaborated on zoonotic viruses, their pathogenesis, epidemiology, and ecology for many years. the late th , and particularly the early st century, have been significantly subject to the risks from emerging deadly zoonotic diseases such as human immunodefi-ciency virus/acquired immune deficiency syndrome (aids), severe acute respiratory syndrome (sars), west nile virus and others. this phenomenon demands the urgent need for all human medical and veterinary medical scientific professionals to renew and increase collaborative efforts. one health has accelerated biomedical research discoveries and expanded scientific knowledge in clinical health care. some clinical health examples are elaborated upon in the one health initiative website articles including cancer, orthopedic biomechanical prosthetics, diabetes, obesity, cardiovascular diseases, heart-valve advances, and vaccine development. the late renowned th century veterinary epidemiologist, parasitologist, and global authority on zoonoses, calvin w. schwabe at the university of california coined the term "one medicine" (now commonly referred to as "one health") which was aimed at unifying human medical and veterinary medical disciplines against zoonotic diseases occurring in the public health arena. two examples of recently emerging zoonotic disease epidemics include the avian influenza a h n strain that primarily affects poultry (with some linked human occurrences) and the most recent human pandemic of h n influenza that has spread across asia, africa, europe and the united states. included among many current and previous online topics from parasites and vectors is the zoonotic protozoan parasite responsible for african trypanosomiasis (sleeping sickness). an excellent history has been provided by steverding [ ] . an interesting common parasite of dogs, i.e. dirofilaria immitis (heartworm) is also a rare zoonotic disease in humans. aspects of this parasitic species and others are described by otranto et al. [ ] . parasitologists, of all the health professional scientists, are generally most familiar with the long list of parasitic zoonoses that affect humans via animals as well as specific details pertaining to each. hence, the critical need for one health research collaborations and cooperation. veterinary medical school students usually receive considerably more exposure to parasitology than do human medical school students. this is largely due to the much greater volume of endoparasite (and ectoparasite) infections and infection rates for animals vis-à-vis humans. thus, epidemiologic prevention, diagnosis, control and treatment needs of animals exceed those for humans. yet, there remain significant research requirements for understanding ideal management in human and animal species utilizing one health principles. the official report of the american public health association's control of communicable diseases manual, th edition, edited by physician david l. heymann, includes a staggering number of zoonotic parasites. heymann, a one health supporter/advocate, is currently chairman of the health protection agency (hpa) with sites across the united kingdom. he is also chairing an australian scientific advisory committee for a one health symposium entitled, "the st international one health congress: human health, animal health, the environment and global survival", tentatively proposed for - february in melbourne. one health supporter/advocate veterinarian, martyn jeggo director, australian animal health laboratory (aahl), chairs the organizing committee responsible for developing a framework for the symposium; aahl will also be working in conjunction with a number of colleges. one health initiative will unite human and veterinary medicine the history of african trypanosomiasis. parasites & vectors changing distribution patterns of canine vector borne diseases in italy: leishmaniosis vs. dirofilariosis. parasites & vectors in addition to african trypanosomiasis and dirofilariasis mentioned above, the global list of parasites of human concern includes amebiasis, angiostrongyliasis, anisakaiasis, ascariasis, babesiosis, balantidiasis, capillariasis, clonorchiasis, cryptosporidiosis, diphyllobothriasis, dracunculiasis, echinococcosis, giardiasis, hookworm disease, hymenolepiasis, leishmaniasis, malaria, shistosomiasis, strongyloidiasis, taeniasis, toxocariasis, toxoplasmosis, trichinellosis, and american trypanosomiasis (chagas disease).in a press release of april , , sanaria inc. announced that with support from the path malaria vaccine initiative (mvi) it has initiated a phase clinical trial of its unique malaria vaccine candidate. sanaria's approach "deploys a weakened form of the whole malaria parasite harvested from irradiated mosquitoes instead of small portions of the parasite." ... "while most malaria vaccines in clinical development consist of recombinant or genetically engineered proteins that represent small portions of the parasite, sanaria's plasmodium falciparum sporozoite vaccine candidate contains a weakened form of the entire malaria parasite." the sanaria vaccine currently requires liquid nitrogen transport and storage, which poses challenges for widespread use in africa.an example of "one health in action" was a recent outreach to the veterinary medical community by monath, one of the co-authors of this editorial in an effort to ascertain methods for vaccine storage and transport. the idea was to investigate and compare how veterinary vaccines were handled and if utilizing or incorporating some of these methods might be utilized and provide better transportation of the human malaria vaccines. a request for information on the distribution of veterinary vaccines using liquid nitrogen placed on the one health initiative website resulted in many potentially useful responses from industry and academia.medical professionals and health scientists must include parasitologists, microbiologists, physiologists, pathologist, physicians, osteopaths, veterinarians, dentists, nurses, biomedical engineers, physicists, biochemists, plant pathologists and others. anyone capable of contributing should be considered important and co-equal without reservations.one health has indeed become the "rosetta stone" for a health enlightening paradigm shift revolution. it is the critical key that translates difficult problem solving into less difficult models. it presents a means for the health scientific communities to move towards a more panoramic view, a sustainable revolution (described as an environmental definition for our civilization to survive) and the pursuit of altruistic excellence, notwithstanding respecta-ble status quo advancements of the past. one health works! the authors declare that they have no competing interests. all authors contributed equally to this work key: cord- -yzozbf p authors: edelstein, burton l. title: disruptive innovations in dentistry date: - - journal: j am dent assoc doi: . /j.adaj. . . sha: doc_id: cord_uid: yzozbf p nan t his commentary is about disruptions underway in dentistry today. it is not about the kind of disruptions that occur unexpectedly like natural disasters or the covid- pandemic but rather about the kind of disruption that can be anticipated by simply scanning the environment looking for incipient changes. this expected kind of disruptiondwhat christensen called "disruptive innovation"dis always present at the periphery of every business, industry, or profession. because it can be anticipated, it can be managed. as dental practitioners and educators, we owe it to today's dental students and young dentists to prepare them to recognize and deal with changes in us health care delivery and financing now underway that will almost surely affect their careers. we need to adopt the approach taken by physicians and medical educators who prepare their students by teaching health systems science in addition to biomedical and clinical science. the american medical association's education consortium puts it plainly in a book introducing health systems science: "over the last decade it has become clearer that trainees require knowledge, attitudes, and skills beyond the scope of, and in addition to, the basic and clinical sciences if they are to be prepared for practice in our current and future health care system." roiling the profession are disruptions in technology, communications, workforce, payment, and management, all driven by creative innovators sponsored by venture capital, nonprofits, and governments alike. churning dentistry's environmentdjust as parallel forces are reshaping medical caredare direct-to-consumer and doit-yourself dentistry like orthodontic aligners, tooth whiteners, and intraoral appliances ; dr. google offering free dental advice on the internet ; dental therapists restoring teeth ; alternative payment mechanisms tied to health outcomes ; and expanding delivery systems like dental service organizations, accountable care organizations, and patient-centered medical homes. there are many change drivers that are persistent and impactful on dental practice: n the internet, which continues to propel an information revolution; n shifting generational values, expectations, and norms of boomers through millennials (with generation z around the corner); n artificial intelligenceeequipped technologies; n consumer demand for low cost and convenience; n large sums of venture capital looking for the next big thing. there are also societal forces churning the larger health care environment: n unaffordability of health care as reflected in mounting medical debt and bankruptcy along with care deferral and self-treatment; n gross class inequities in health care that leave too many helpless in the face of illness or injury; n recognition from the disciplines of public health that more of our health comes from social, environmental, and behavioral determinants than from our health care system and its doctors. for dentistry, the single most important change driver is unaffordability of care. we simply have outpriced ourselves for far too many people, particularly adults with and without dental insurance. the american dental association's (ada) chief economist and vice president of the health policy institute (hpi), marko vujicic, and his colleagues captured this message in the title of a article in the influential journal health affairs titled "dental care presents the highest level of financial barriers, compared to other types of health care services." multiple hpi publications document the problem of unaffordability and the downward trend in adult oral health care use. hpi's annual dental industry report notes, "declining dental care utilization rates among adults with and without dental insurance are the main drivers of the shrinking adult population base among dentists." capturing this problem, ada president dr. chad p. gehani, when asked by ada news about the biggest issues facing dentistry today, responded, "for the profession, consumerism. our patients look upon us as providers of service. they look for convenience and cost effectiveness." what happens when an established industry, like traditional dentistry, does not respond sufficiently to its consumers (patients) as they look for convenience and cost-effectiveness? according to christensen and colleagues, "in any industry . while the dominant players are focused on improving their products and services . they miss simpler, more convenient, and less costly offerings initially designed to appeal to the low end of the market." dentistry has long been actively engaged in improving its products and services for its core highend patient market through expensive new technologies, materials, techniques, and payment arrangements. these begin in upscale markets before sifting downward to the overall dental market if they do so at all. technologies like computer-aided design and computer-aided manufacturing, lasers, and older transitions (for example, from foot pedal and motor-driven belt handpieces to airdriven high-speed units) entered dentistry wherein substantial fees could support their high-cost acquisition. similarly, new dental materials that sparked the adhesive revolution and enhanced cosmetic dentistry, new techniques like dental implants and high-tech endodontics that left highincome people with more teeth than lower-income people, and payment arrangements through dental insurance that benefited those with higher-paying jobs all followed the same high-to-low path into dental practice. today, looking at the low end of the dental market, we see a host of disruptive innovations important to dentistry's future that mostly work in the opposite direction: from the low-to-high social aspects of the dental industry. these can be categorized as a -tiered hierarchy, with the first tiers already clearly evident and the higher tiers just now evolving. tier dental disruption comprises efforts to aggregate practices and enhance their business operation efficiencies. early efforts at group practice are typified by schoen's collaboration with the international longshore and warehouse union in the s to establish oral health care for young children. today, these are evident in the decline of solo and small partnership practices and the increase in dental support organizations (dsos). as early as , lipscomb and douglass noted that group practices increase efficiency and reduce overhead. they also wondered "whether these apparent production efficiencies . are ultimately translated by the market into lower fees, shorter queues, or other nonprice benefits." clearly, the answer has been "no." rather than benefiting patients, these efficiencies now profit the many entities that grew ever-larger dental groups and provided them with business services. tier dental disruption occurs when innovators fill market voids in which mainstream dentistry either fails to recognize or attend to unmet demand. a prime example was high demand for oral health care by families of publicly insured children (a low-end market). lower-income parents faced significant challenges finding medicaid-participating dentists who accept children. when they did, they sometimes confronted transportation, language, cultural, and other care barriers that left them unsatisfied. into the marketplace came dsos with a pediatric-dental medicaid-only practice model that operated efficiently, provided high volumes of care, was profitable, and met low-end consumers with convenience. by , an estimated % of the million children enrolled in medicaid who had a dental visit were treated at of these pediatric medicaid-focused dsos. consistent with the theory of disruptive innovation, this innovation subsequently influenced mainstream dentistry with ever greater proportions of pediatric dentists participating actively in public insurance. tier dental disruption aims to modify the very structures that characterize dentistry by changing key components of how dentistry operates. no longer tinkering around the edges (as in tier and tier ), tier innovators ask whether the way dentistry operates still works for patients and if not, what might work better. as with other disruptive innovations described by christensen's theory, this often begins in the low end of the market as evidenced by the advent of dental therapists, whom state legislators endorse as solutions to inequitable access, sometimes seeking to limit their deployment to safety-net sites. other examples that offer convenience, cost-effectiveness for the payer, or presumed value for the consumer include teledentistry targeted to homebound and other underserved groups, employer-located dental services, cosmetic kiosks in malls, anddpotentially most impactful to dentistry's future modeldan expansion of pay-for-performance into alternative payment mechanisms (apms) that replace fee-for-service payments. apms that are already evident in medicine seek to ensure value by assessing health outcomes against cost. these range from ffs linked to quality and value to apms with shared savings and shared [financial] risk to populationbased payments that blur the lines between insurers and health systems. tier dental disruption borrows heavily from public health principles in seeking to change the very content of oral health care by calling on the profession to address the social, behavioral, and environmental determinants of oral health along with providing traditional dental procedures. these principles include allocating scarce resources to those with the greatest need, going upstream to prioritize prevention and disease management, addressing the full range of health determinants, and providing care within the contexts of family and community. they are reflected in the growth of accountable care organizations, patient-centered health homes, and other holistic, interdisciplinary, and outcome-oriented approaches to health care. one novel disruptive enterprise in medicine that reflects this approach is cityblock. this primary care medical model "bring[s] together primary care, behavioral health, and social services to delivery better care for every member." it was "founded on the premise that health starts at the neighborhood level." it "aim[s] to build a new kind of care model that addresses the root causes of health" and seeks to "improve health in communities that have previously been underserved." a dental example is columbia university's mysmilebuddy program (funded in part by the center for medicare & medicaid innovation and the national institutes for health), which fields technology-assisted community health care workers into the homes of children experiencing early childhood caries. these lay health care workers engage parents in sustained adoption of healthy dietary and hygiene practices to arrest caries and reduce the need for dental repair under general anesthesia. calls for expanding dentists' roles and responsibilities to include primary medical care screening and preventive guidance is an additional example of potential change in the content of care. [ ] [ ] [ ] each successive tier of innovation and disruption enhances dentistry's value proposition for our patients and would-be patients. consistent with christensen's work, each offers "simpler, more convenient, and less costly offerings." each holds potential to eventually change the character of dentistry as it has been practiced traditionally. disruptive innovations inform the discipline of health systems science, which seeks to enhance the value, quality, and safety of health care while promoting improved population-level health outcomes. with rapid change underway in us health care, now is the time to integrate this expanding sciencedalong with biomedical and clinical sciencedinto dental education from the first day of dental school to the last day of continuing dental education. many changes underway in dentistry today are potentially more disruptive to traditional care models than in the past because they reflect the larger us health care environment and because they enter dentistry through the low-end of the market. potential changes will affect where and how care is delivered and how dentists will be paid. dentists need to be aware of and prepared for these changes. n the innovator's dilemma: when new technologies cause great firms to fail dental education required for the changing health care environment pew charitable trusts. what are dental therapists: faqs about practitioners who provide care in a growing number of states dental care presents the highest level of financial barriers, compared to other types of health care services american dental association health policy institute gehani: transforming the face of dentistry will disruptive innovations cure health care? group practice in dentistry are larger dental practices more efficient? an analysis of dental services production children's dental health project. dental visits for medicaid children: analysis & policy recommendations feasibility, acceptability, and short-term behavioral impact of the mysmilebuddy intervention for early childhood caries a model for dental practice in the st century primary care in dentistry: an untapped potential should dental schools train dentists to routinely provide limited preventive primary medical care? two viewpoints key: cord- -oq pax authors: morris, chad d.; garver-apgar, christine e. title: nicotine and opioids: a call for co-treatment as the standard of care date: - - journal: j behav health serv res doi: . /s - - - sha: doc_id: cord_uid: oq pax the u.s. is in the midst of an opioid epidemic. at the same time, tobacco use remains the leading cause of preventable death and disability. while the shared biological underpinnings of nicotine and opioid addiction are well established, clinical implications for co-treatment of these two substance use disorders has not been emphasized in the literature, nor have researchers, clinicians, and policy makers adequately outlined pathways for incorporating co-treatment into existing clinical workflows. the current brief review characterizes the metabolic and neural mechanisms which mediate co-use of nicotine and opioids, and then outlines clinical and policy implications for concurrently addressing these two deadly epidemics. screening, assessment, medication-assisted treatment (mat), and tobacco-free policy are discussed. the evidence suggests that clinical care and policies that facilitate co-treatment are an expedient means of delivering healthcare to individuals that result in better health for the population while also meeting patients’ substance abuse disorder recovery goals. healthcare providers have a critical opportunity to concurrently address tobacco and opioid dependence. the policy spotlight on the u.s. opioid epidemic and the dramatic increase in overdose deaths presents an opportunity to bring renewed focus on strategies that potentiate addiction treatment, including nicotine addiction treatment. over-prescription of opioid pain relievers beginning in the s led to a rapid escalation of dependence, a resurgence of heroin use, and arrival of powerful synthetic opioids such as fentanyl which increased % from to . , in , there were , drug overdose deaths in the u.s., and heroin overdoses more than tripled from to . in the face of these dire statistics, smoking is often seen as less harmful and a lower treatment priority than opioids which represent a clear, imminent risk. yet, smoking combustible tobacco products, not opioid use, remains the leading cause of death and disability in the u.s., with at least , dying annually due to smoking-related causes. the general prevalence of current cigarette smoking among u.s. adults is % ( % for men and % for women). smoking is highest among those aged - ( %) and - ( %) . hispanic adults ( %) are less likely to be current smokers compared with non-hispanic black ( %) and non-hispanic white adults ( %). in comparison, smoking prevalence among patients using illicit opioids or who are receiving methadone maintenance treatment is between and %. [ ] [ ] [ ] [ ] [ ] this is an extremely high rate of co-use even when compared to co-use with other illicit drugs or alcohol. for instance, % of heroin users in one study of methadone or buprenorphine treatment used an average of cigarettes or a pack per day. co-occurring tobacco and opioid use creates an additive effect of increasing toxicity and related health consequences across all body systems, leading these users to face unnecessarily high mortality and morbidity. , while the shared biological underpinnings of nicotine and opioid addiction are well-established, clinical and policy implications have garnered limited attention. smoking is a primary risk factor for opioid addiction, and there is ample evidence that co-treatment of tobacco and opioid use leads to better outcomes among those seeking treatment for drug use generally and opioid addiction specifically. this article summarizes the neurobiological and clinical evidence suggesting that there is a clinical and ethical imperative to promote co-treatment models as a necessary standard of care. using both opioids and tobacco may enhance subjective positive effects and satisfaction with drug use, reduce withdrawal symptoms for both substances, and act as a substitution when one drug is unavailable. , co-use leads to the increased use of one or both substances through priming, extending reinforcement, and cross-tolerance, thus making abstinence from either substance more difficult. , , in part, cross-tolerance occurs because combustible tobacco use produces polycyclic aromatic hydrocarbons which induce faster metabolism of opioids through induction of hepatic cytochrome p- a -isoenzymes. while infrequent, this effect can lead to opioid toxicity when patients quit smoking. there is also evidence that past smokers using nicotine replacement therapy (nrt) use opioids at the same level as current smokers. as nrt does not produce polycyclic aromatic hydrocarbons, this indicates additional biological mechanisms of cross-tolerance. these bidirectional priming and tolerance between nicotine and opioids include illicit drugs as well as prescribed use of methadone and buprenorphine. , in addition to cross tolerance, polysubstance use heightens reinforcement because opioids and tobacco similarly stimulate reward pathways including the dopaminergic, cannabinoid, and nicotinic-acetylcholine (nachr) systems. , as a result of these related metabolic and neural processes, smoking increases opioid use, including opioid replacement medication use. at the same time, opioid use including prescription replacement drugs reinforces smoking patterns. , chronic pain is also implicated in co-use of tobacco and opioids. current smoking among persons suffering chronic pain ranges from to %, , and findings suggest that there are no significant associations between smoking status and ethnicity, sex, or age. paradoxically, acute nicotine use is known to have short-term analgesic effects, but ongoing use leads to chronic pain. nicotine initially releases endogenous opioids [ ] [ ] [ ] and potentiates opioid-induced antinociception and activates the pain inhibitory pathways in the spinal cord. [ ] [ ] [ ] chronic nicotine exposure leads to tolerance to this analgesic effect. indeed, ongoing smoking becomes a risk factor for the onset or exacerbation of back pain, sciatica, arthritis, fibromyalgia, and chronic headache. [ ] [ ] [ ] [ ] [ ] nicotine (or perhaps another component in tobacco smoke) may sensitize pain receptors, decrease pain tolerance, and increase pain awareness. prospective cohort studies of adolescents bear this out, demonstrating that smoking early in life causes chronic back pain leading to related hospitalizations, initial opioid use, and potential opioid addiction persisting into adulthood. [ ] [ ] [ ] logically, it would follow that smoking cessation might then be a treatment for chronic pain, , but randomized controlled trials have not substantiated this hypothesis. continued research is needed to further elucidate the complex relationship between smoking and pain. regardless of causality, smokers are at increased risk for chronic pain of higher intensity, increased number of painful sites, and more associated disability and adverse effects on occupational and social functioning. , , [ ] [ ] [ ] smokers have higher pain scores and higher need for opioids during surgery and postoperatively compared to nonsmokers. and studies have found that, in comparison to non-smokers, smokers are more likely to be on opioid pain treatment for longer durations and at higher dosages. higher levels of reported pain among smokers may also be related to elevated levels of depression, and in turn, anxiety and depression heighten the motivation to smoke and increase severity of nicotine withdrawal and pain sensitivity. therefore, there is some evidence that treating psychiatric symptoms will lead to improvements in pain symptoms, which may then potentiate reductions in polysubstance use. there is mounting evidence that addressing smoking and other drug use concurrently leads to improved psychiatric and polysubstance use outcomes. [ ] [ ] [ ] [ ] [ ] [ ] at minimum, research has found that smoking cessation while in treatment has no effect on other drug use outcomes. , encouragingly, meta-analysis of randomized controlled trials of smoking cessation interventions found that individuals who treat their addiction to tobacco and other substances simultaneously are % more likely to sustain their recovery, compared to individuals who do not address tobacco while in treatment from other drugs. as an extension of this meta-analysis, mckelvey and colleagues synthesized the evidence across studies to show the positive impact of smoking cessation on substance use disorder (sud) outcomes. both quitting smoking and smoking cessation treatment interventions had either a positive impact or no impact on substance use outcomes. positive sud impacts included reduced drug use and continued abstinence. in contrast to many healthcare providers' beliefs, patients in treatment for opioids desire assistance with smoking cessation, with % to % of methadone maintenance clients wanting to quit smoking. , the longer patients receive methadone maintenance therapy, the more motivated they become to quit smoking. , [ ] [ ] [ ] due to sud patients' overlapping genetic, neurobiological, and environmental characteristics, similar population level, behavioral, medication, and social service interventions are effective across substance use disorders. but despite the clear benefits of co-treatment and the fact that patients desire to quit smoking, tobacco cessation services remain infrequently offered in sud treatment settings. , less than half of sud treatment centers ( - %) offer tobacco cessation services. , generally, there are an insufficient number of addiction specialists, and among addiction medicine professionals, the majority receive little training regarding integration of tobacco cessation screening, assessment, referral, and treatment into daily practice. there are a number of oft cited barriers to addressing smoking in treatment settings including concerns that agency census levels and completion rates will drop, tobacco users will be less likely to seek addiction treatment, patients are neither interested in tobacco cessation nor able to successfully quit tobacco, patients will relapse to alcohol or drug use if they attempted to quit tobacco, tobacco-free policies will be difficult to enforce, clinicians lack the skills to effectively treat tobacco dependence, and clinicians have too many competing demands preventing attention to smoking cessation. , - also, few treatment agencies have a designated leader or formalized procedures related to smoking cessation services, the ability to prescribe smoking cessation pharmacotherapies, or an existing budget for cessation interventions. historically, many addiction treatment facilities have not only allowed but actively reinforced smoking. healthcare providers continue to widely hold the perspective that smoking cannot be treated concurrently with other substance use. in many cases, smoking is directly or indirectly condoned in treatment settings, with a large proportion of sud treatment providers smoking themselves and smoking with patients while in treatment. , indeed, many patients with sud report that they first began smoking in addictions or other psychiatric treatment environments. additionally, compared to treatment settings where smoking is not allowed, continued smoking in treatment settings is associated with increased opioid withdrawal and cravings, more cigarette use at follow-up, and lower detox completion. , [ ] [ ] [ ] organizational affiliation has also played a role in smoking cessation efforts in sud and other healthcare settings. over the last decade, cessation services in federally qualified healthcare centers (fqhcs) have been reinforced by health resources & services administration (hrsa) tobacco use measures, the ability to bill under the centers for medicare and medicaid services (cms), and the patient protection and affordable care act. in the behavioral health sector, early state intiatives mandating tobacco policy and cessation services for substance disorder treatment facilities , have been reinvigorated on a national level through the efforts of such organizations as the national association of state mental health program directors (nasmhpd), federal substance abuse and mental health services administration (samhsa), smoking cessation leadership center (sclc), and national council for behavioral health (national council). while the cultural shift has been slow, co-treatment of opioids and nicotine addiction among statefunded sud treatment agencies and opioid treatment centers continues to gather momentum. tobacco-free policy facilitators for adequately addressing both tobacco and opioid use include having a lower number of clinicians who smoke, patient incentives, senior leadership support, and ongoing staff training in evidence-based treatment strategies. , tobacco-free policies also heighten clinical effectiveness. ample evidence suggests that tobacco-free campus policies support co-treatment and should be implemented by treatment agencies. , when treatment agencies implement comprehensive tobacco-free policies that include the facility grounds, patients' attitudes about quitting are improved, they receive more tobacco cessation services, and the intent to quit smoking increases. tobacco policies not only support quit attempts, but also prevent the initiation of smoking which is associated with higher odds of drug use relapse. policies can be created by individual agencies or mandated statewide. new york has, among other states, instituted statewide policies among funded sud treatment agencies. , within inpatient treatment settings, neither forced quit attempts, i.e., smoke-free policies, nor smoking cessation treatment interventions negatively affect other drug use treatment outcomes. furthermore, studies show no evidence that smoke-free policies instituted in inpatient treatment settings adversely impact patient census rates. screening, brief interventions, and referral a systematic screening, treatment, and referral structure is necessary to adequately address drug use. in behavioral health treatment settings, screening, brief intervention, and referral to treatment (i.e., sbirt) were originally developed to detect risky substance use and direct providers to intervene early using motivational enhancement strategies. [ ] [ ] [ ] while sbirt has been demonstrated to be effective for risky alcohol use, there is growing yet varied evidence of effectiveness for other drug use. [ ] [ ] [ ] recently, bernstein and d'onofrio made modifications to sbirt, creating a model referred to as stir (screening, treatment initiation, and referral). the primary difference between sbirt and stir is that stir prompts clinicians to initiate pharmacotherapy for illicit opioid or tobacco use during the initial visit. recent studies of stir in emergency departments have demonstrated increased patient engagement and decrease in both tobacco and opioid use. the equivalent of sbirt in tobacco control environments is referred to as the " as" (ask about tobacco use, advise to quit through clear personalized messages, assess willingness to quit, assist to quit, and arrange follow-up and support). , implementation of the as in heterogeneous healthcare settings has been an impetus for greater attention to tobacco use, with brief advice from physicians and other clinicians associated with patients' successful quit attempts. , utilizing the sbirt, stir or the as model, healthcare providers in sud or primary care settings are much more likely to screen for tobacco use, assess, and advise abstinence, but unfortunately are less likely to follow these actions by providing brief treatment, medicationassisted treatment (mat), or appropriate referral. [ ] [ ] [ ] this is a substantial practice gap that has been difficult to narrow. , the infrequency of appropriate referrals and evidence-based treatments point to the necessity of interdisciplinary healthcare teams as physicians are less responsive than other providers (e.g., nurse practitioners and physicians' assistants) to systemic efforts to increase tobacco cessation treatment. additionally, regardless of the screening and brief intervention model employed, establishing a sud patient registry, which includes both opioids and nicotine use, within a practice-based research and/or health care network allows for better data aggregation, patient identification, and stratification to appropriate treatment levels. medication-assisted treatment appropriate treatment across substance use disorders typically involves mat, consisting of a combination of behavioral interventions and medications. the synergistic effects of mat apply as equally to smoking cessation as it does to opioid maintenance treatment. research shows that both tobacco and opioid use treatment should include fdaapproved medications to treat dependence and maximize healthcare utilization. for opioid dependence, methadone and buprenorphine are approved, as well as naloxone for overdose. for tobacco cessation, a combination of behavioral strategies and seven fda-approved medications are the most effective means of quitting smoking. medications plus behavioral counseling lead to tobacco cessation rates of - % compared to unaided quit attempts with a success rate of - %. for the general population, all fda-approved cessation pharmacotherapy improves the chances of smoking cessation at -month follow-up or longer, compared to placebo. a review of reviews found that nrt and bupropion increase the likelihood that a person will be abstinent from tobacco at months post-quit by about %, while varenicline more than doubles the likelihood of abstinence at months compared to a placebo. the eagles study further demonstrated the superior efficacy of varenicline for both psychiatric and non-psychiatric populations and confirmed past findings that there were no significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo. , for persons abusing opioids or taking opioid replacement medications, the interaction between opioids and nicotine may explain the reduced efficacy of nrt for this population. this is further supported by the finding that the lower the dose of opioid replacement medications taken, the more likely patients are to quit smoking. due to mixed findings regarding the efficacy of nrt for patients in opioid dependence treatment, unless contraindicated or unavailable, bupropion which acts on dopaminergic neurons or varenicline which is a partial agonist of the α β nicotinic acetylcholine receptor will be better first-line options. , [ ] [ ] [ ] this is particularly the case if providers can address general low adherence to taking medication capsules. importantly, clinician training is necessary to ensure that cessation medications are prescribed in combination and at therapeutic dosages meeting individual dependence levels. this is imperative, as treatment failures often result from under-dosing cessation medications. patients should be directed to use combination medications, such as veranicline, bupropion, or long-lasting nrt (e.g., patch) with rescue medication (e.g., nrt gum, or lozenge) to control break-through cravings. , currently, there is a great amount of attention to vaping as a potential harm reduction strategy among smokers. many smokers are using vaping products as the primary means of quitting or reducing smoking. while safer than combustible tobacco use, vaping is not necessarily safe. vaping, as well as smoking, may put individuals at increased risk for respiratory illness and infectious diseases like covid- . the end goal for all patients is abstinence from all nicotine products. electronic nicotine devices (ends) are not fda-approved smoking cessation aids, and the efficacy of these products for long-term abstinence from conventional cigarettes is uncertain. ends may help some smokers quit; however, the data are mixed, with some studies finding that ends users do not completely discontinue combustible tobacco products, resulting in no improvement in health outcomes, , , and others continue ends use indefinitely. similar to nicotine addiction, mat is also the most effective treatment option for individuals who abuse opioids. mat doubles opioid abstinence rates , and should be provided days or longer. all fda-approved medications for opioid use disorder are clinically effective, with opioid agonists (methadone) or partial agonists (burprenorphine) reducing withdrawal symptoms and the addictive effects of illicit opioids. methadone is the most commonly used and studied medication. some medications have been shown more effective, , with buprenorphine shown effective in maintaining treatment engagement and abstinence. more than half of patients addicted to prescription opioids treated with buprenorphine and naloxone reported they were not misusing opioid prescription drugs months after starting treatment. buprenorphine has the advantage of flexible administration, either daily, monthly, or every months, but is limited by what type of healthcare providers is able to prescribe buprenorphine and what number of patients they can treat. extended-release injectable naltrexone, and opioid antgonist, is also approved for treatment of people with opioid use disorder. any prescriber can provide naltrexone following a medically managed withdrawal. there is evidence that naltrexone both reduces cravings from opioids and helps with short-term smoking abstinence, particularly for individuals with depression or alcohol dependence. [ ] [ ] [ ] for both opioid and tobacco use, behavioral treatment components of mat include motivational interviewing (mi) or motivational enhancement techniques which are effective across substance use disorders. , these interventions increase motivation for behavioral change and treatment engagement. during brief mi, non-judgmental, open-ended reflective responses, affirmations and well-timed summaries serve to mirror and reinforce the benefits of behavior change and patients' self-efficacy. once in treatment, contingency management (e.g., monetary reinforcement), cognitive behavioral therapy (cbt), and other variants of cognitive and behavioral interventions are proven treatments. relapse prevention is also necessary to train individuals to mitigate pain, avoid high-risk situations, and practice replacement coping skills. , behavioral strategies might be employed whether individuals are initially seeking treatment for tobacco use, opioid use, or chronic pain. for example, patient pain motivates a large proportion of physician visits, and such visits could provide a "teachable moment" for addressing smoking and pain medications. one study found that, when educated about the relationship between pain and tobacco use, patients seeking outpatient pain treatment were over seven times more willing to consider quitting smoking. it also may be helpful for clinicians to assess the role of anxiety and depression in the intersection of pain, smoking, and opioid use. the "quadruple aim" of the healthcare system is to deliver quality, lower cost healthcare to individuals, and improve the work life of healthcare providers resulting in better population health. , one of the most expedient means of accomplishing the quadruple aim is to address patients' concurrent smoking and opioid use. co-treatment models address the fact that polysubstance use is the norm, not the exception. the majority of adults with sud are interested in quitting smoking and motivated to quit at rates consistent with the general population, but they are not afforded timely, evidence-based treatment options as detailed in the public health service guidelines. as a result, patients may overcome their opioid addiction to then die or have severe health issues which are smoking related. while additional work is needed to better understand how overlapping neural mechanisms contribute to opioid and nicotine addiction, the existing evidence supports co-treatment, buttressed by tobacco-free policies, as a standard of care. screening and brief intervention is one of the three top preventive services in terms of cost savings and the potential to improve overall population health. , moreover, promotion of mat and appropriate referral across addictions (e.g., telephonic services for polysubstance use) hold great promise. multilevel changes are needed to foster co-treatment in sud treatment settings. at an organizational level, the first goal of co-treatment is the denormalization of tobacco use and other nicotine products by implementing and reinforcing a comprehensive tobacco-free policy. as part of a comprehensive policy, all patients who smoke, vape, or are at risk for relapse to nicotine use should be offered mat. to do so, agencies must provide the infrastructure for mat using the standardized as model (or sbirt, stir variant previously described) with the expectation that clinicians ask, advise, and assess for opioid and nicotine dependence simultaneously. there are proven steps toward taking inpatient, outpatient, and residential treatment settings tobacco free and providing mat services. one such resource, the dimensions tobacco free policy toolkit provides guidance, timelines, and templates for written policy and workflow implementation. at a provider level, interdisciplinary staff must be trained in evidence-based practices for engaging patients, assessing use, and providing treatments for both opioids and tobacco. a number of evidence-based resources are available from the university of colorado including tobacco-free treatment toolkits, as and mi video training modules, and interdisciplinary workflow models (https://www.bhwellness.org/resources). these resources detail behavioral interventions and pharmacology, including how medication levels may be affected by tobacco use reduction and quit attempts. providers are further encouraged to take advantage of the resources and model programming continuously updated by the national behavioral health network for tobacco and cancer control (nbhn) (www.bhthechange.org) administered by the national council. nbhn is one of the eight centers for disease control and prevention (cdc) national networks created to eliminate tobacco-and cancer-related disparities. the smoking cessation leadership center is another site with a wealth of archived training opportunities (https:// smokingcessationleadership.ucsf.edu). several states are building on these training resources to additionally offer opioid treatment program opportunities to participate in a community of practice (cop). the cop is a virtual peer learning environment which fosters discussion of barriers and facilitators to care, as well as specific issues such as mat, polypharmacy, treatment planning, billing, and health systems change. a current example is the washington state department of health which funds the tobacco free behavioral health initiative where opioid treatment network staff are invited to receive tobacco treatment specialist training and also participate in a cop. simultaneous opioid and tobacco treatment planning is typically appropriate, and providers will treat tobacco dependence more effectively if it is considered "opt-out" care. all patients will benefit by brief mi interventions to build motivation for treatment. while studies have demonstrated the feasibility of treating nicotine dependence in patients with sud, there is still some debate as to whether tobacco and other sud treatment should be delivered simultaneously or sequentially. there are valid concerns that fewer patients will engage in delayed treatment, but opt-out care is best operationalized as a person-centered, strength-based approach aligned with each patient's motivation, readiness, and available resources. patients should partner with providers to determine to what degree nicotine and opioid use are simultaneously treated. as detailed earlier, standard mat, including proven fda medications, should be utilized during co-treatment of opioids and tobacco. providers should adhere to standards of care for the general population, but be able to tailor the dosage of pharmacotherapy and counseling to sud patients that will typically have high nicotine dependency levels and complex care needs. regarding behavioral strategies, education on polysubstance dependence can be provided in a synergistic manner and readiness to quit nicotine use should be routinely reassessed. the majority of issues polysubstance users face are cross-cutting and the proven behavioral therapies previously discussed are appropriate in varied modalities and formats for opioid or nicotine dependence and can be utilized to simultaneously or independently to address polysubstance dependence. at a minimum, providers can make warm hand-offs to state quitlines at - -quit-now which are available in every state. quitlines offer varied combinations of telephonic counseling, pharmacotherapy, and online and texting resources at no cost. that said, siloed systems and treatment protocols can lead to patient burden, lower quality of care, and non-adherence. referrals to quitlines and other community resources are encouraged. at the same time, agencies should provide treatment onsite employing a collaborative care model, team-based care, patient-centered resources, registries, and other sufficient infrastructure. [ ] [ ] [ ] there are limitations to the extant knowledge base. further work needs to determine if concurrent versus sequential or staged treatment models are most effective, and if this effectiveness differs by type of treatment setting. new technology platforms, accountability mechanisms, payment approaches, and incentive systems for the hardest to reach underserved populations also require testing. that said, pain clinics, behavioral health treatment settings, methadone, and other opioid treatment programs represent opportunities to also address smoking. patients with polysubstance use are largely motivated for co-treatment to overcome addictions which are biologically, psychologically, and socially overlapping. with relatively little additional training and favorable attitudes, interdisciplinary healthcare professionals have the ability to concurrently address two deadly epidemics, opioid and nicotine addiction. conflict of interest the authors declare that they have no conflict of 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moore, jason h.; barnett, ian; boland, mary regina; chen, yong; demiris, george; gonzalez-hernandez, graciela; herman, daniel s.; himes, blanca e.; hubbard, rebecca a.; kim, dokyoon; morris, jeffrey s.; mowery, danielle l.; ritchie, marylyn d.; shen, li; urbanowicz, ryan; holmes, john h. title: ideas for how informaticians can get involved with covid- research date: - - journal: biodata min doi: . /s - - -y sha: doc_id: cord_uid: zzkqb u the coronavirus disease (covid- ) pandemic has had a significant impact on population health and wellbeing. biomedical informatics is central to covid- research efforts and for the delivery of healthcare for covid- patients. critical to this effort is the participation of informaticians who typically work on other basic science or clinical problems. the goal of this editorial is to highlight some examples of covid- research areas that could benefit from informatics expertise. each research idea summarizes the covid- application area, followed by an informatics methodology, approach, or technology that could make a contribution. it is our hope that this piece will motivate and make it easy for some informaticians to adopt covid- research projects. the coronavirus disease (covid- ) pandemic has had a significant impact on population health and wellbeing. research efforts are underway to identify vaccines [ ] , improve testing [ , ] , understand transmission [ ] , develop serologic tests [ ] , develop therapies [ ] , predict risk [ ] , and develop mitigation and prevention strategies [ , ] . biomedical informatics is central to each of these research efforts and for the delivery of healthcare for covid- patients. critical to this effort is the participation of informaticians who typically work on other basic science or clinical problems. the goal of this editorial is to highlight some examples of covid- research areas that could benefit from informatics expertise. each research idea summarizes the covid- application area followed by an informatics methodology, approach, or technology that could make a contribution. this is followed by some practical suggestions for getting started. these are organized under sub-disciplines for biomedical informatics including bioinformatics that focuses on basic science questions, clinical informatics that focuses on the delivery of healthcare, clinical research informatics that focuses on research using clinical data, consumer health informatics that focuses on the use of mobile devices and telemedicine, and public health informatics that focuses on research questions at the population or community level. it is our hope that this piece will provide motivation and make it easy for some informaticians to adopt covid- research projects. we present here two applications of bioinformatics approaches to the basic science aspects of severe acute respiratory syndrome coronavirus (sars-cov- ) and covid- . these focus on sequencing the virus, in order to understand the genomics of sars-cov- with the goal of informing treatment regimens and vaccine development. the genome sequences of sars-cov- are essential to design and evaluate diagnostic tests, to track the spread of disease outbreak, and to ultimately discover potential intervention strategies. phylogenetics is the study of the evolutionary connections and relationships among individuals or groups of species. these relationships can be identified through phylogenetic inference methods that evaluate the evolutionary origins of traits of interest, such as dna sequences. similar to tracing your ancestry through a dna test, a phylogenetic analysis approach can be used to help map some of the original spread of the new coronavirus and trace a sars-cov- family tree based on its rapid mutations, which creates different viral lineages. note that many countries have shared an increasing number of sars-cov- genome sequences and related clinical and epidemiological data via the global initiative on sharing all influenza data or gisaid (https://www.gisaid. org). gisaid has generated a phylogenetic tree of sars-cov- genome samples between december and april . in particular, nextstrain, an open-source software package (https://nextstrain.org), uses sars-cov- genome data to help track the spread of disease outbreaks. for example, it could be applied to tell researchers where new cases of the coronavirus are coming from. this can be crucial information for investigating whether new cases arrived in given countries through international travel or local infection. one caveat is that the number of genetic differences among the sars-cov- genomes is close to the error rate of the sequencing process. thus, there is a possibility that some of the observed genetic differences may be artifacts of this process. however, rapid data sharing for sars-cov- is the key to public health action and has led to faster-thanever outbreak research. with more data sharing of the sars-cov- genomes, more genetic diversity will become apparent making it possible to better understand how the coronavirus is being transmitted. while exploring the genome sequence of the sars-cov- virus is anticipated to provide scientists a better understanding of viral evolution and aid in the development of vaccines and treatments, evaluation of host genetics in response to covid- is of similar importance. for other viruses, we know that some individuals have a natural immunity whereby even when exposed to the virus, they do not develop infection. for example, the well-known ccr -delta allele has a variation that protects individuals who have been exposed to the human immunodeficiency virus (hiv); they are protected from developing aids (acquired immunodeficiency syndrome) [ ] . because of this, researchers are gearing up to study the genomes of covid- positive patients in comparison to controls (covid- -negative patients). for example, stawiski et al. investigated coding variation in the gene, ace . ace , the human angiotensinconverting enzyme , is a cell surface protein that the viral spike coat protein sars-cov- engages to invade the host cell [ ] . what would be optimal for these and other genome-wide analyses, to identify potential risk and protective variants, are individuals who test positive for the virus but remain asymptomatic. these individuals will be more difficult to identify because of the lack of widespread testing (most individuals without symptoms are not being tested). however, the research community is building large, international, collaborative consortia to address this challenge, such as the covid- host genetics initiative (https://www.covid hg.org/). much like understanding the viral genome will be useful for drug development, identifying the genetic variation in the host dna that is either increasing the risk of, or protection from, sars-cov- infection will enable us to identify putative targets for therapeutics and vaccines. we present here three topics relevant to the diagnosis and management of covid- patients. these include imaging, suggestions for the roles that informaticians can assume in the pandemic, and the need for novel approaches to delivering patient care and learning from in-practice data. imaging provides a powerful tool for covid- diagnosis and patient monitoring given the impact on lung physiology and anatomy. for example, chest computed tomography (ct) has been shown to have promising sensitivity and early detection power compared with the standard reverse transcriptase polymerase chain reaction (rt-pcr) test [ ] . in addition, imaging plays an important role in assessing patients with worsening respiratory status [ ] , which is crucial for monitoring and treatment planning. given the fast-growing volume of covid- cases, to help alleviate the huge manual evaluation burden on clinicians, there is an urgent call for researchers in imaging informatics (or radiomics) to work on developing automated image analysis and artificial intelligence (ai) methods and tools. to achieve these goals, major efforts have been initiated to address two critical research foci. the first is to create large-scale high-quality imaging data repositories (e.g., radiological society of north america (rsna) covid- imaging data repository, https://www.rsna.org/covid- ) to accelerate collaborative research on image-based covid- diagnosis and treatment. the second is to develop innovative ai methods for automatic image analysis for covid- diagnosis and severity assessment. to get started on supporting these efforts, below we suggest a few relevant resources for interested imaging informaticians. several covid- resource and initiative web portals have been created by major organizations such as american college of radiology (acr), radiological society of north america (rsna), and european society of medical imaging informatics (eusomii). these portals offer important information on policies, guidelines, discoveries, initiatives, data sets, and/or other relevant resources. given the rapidly growing ai-based imaging literature on covid- , it is worth noting a recent review article [ ] , which provides comprehensive coverage on a variety of interesting topics, including ai-empowered contactless imaging workflow, ai in lung image segmentation, ai-assisted diagnosis and severity assessment, ai in follow-up studies, public imaging datasets for covid- , and future directions. to effectively address the ever-growing surge of covid- patient cases, informatics solutions are being developed to help care providers and healthcare institutions manage patients from symptoms to recovery. symptom screening tools have been developed to aid patients in distinguishing covid- symptoms from common colds and flu. telemedicine is helping keep patients at home by deploying chatbots to answer patient covid- questions and providing virtual visits and consultations to limit the number of individuals exposed to covid- and to manage patients with mild covid- symptoms. this reduces resource utilization and overburden on the care delivery system. capacity and resource management tools can generate projects based on regional infection counts and current patient admissions to estimate the number of patients that will require hospitalization, intensive care unit beds, medications, and mechanical ventilation. these projections can improve clinical response times and inform triage care strategies. donation and resource inventory tools can be helpful for identifying, cataloging, and distributing personal protective equipment (ppe), homemade masks, and other critical medical supplies to those fighting on the front lines. informaticians can support these efforts by ) educating patients and care providers about data science resources and electronic health record (ehr) platforms for building point-of-care solutions, ) joining the open-source community efforts to develop these technologies, and ) volunteering with the information services divisions within their healthcare organizations to deploy telehealth tools and engage in patient management projects. the covid- pandemic has been an unprecedented stress test for clinical information systems. the scramble to develop and implement new clinical practices has in many cases outpaced our ability to effectively use standard tools for building, testing, and monitoring these practices. for instance, clinical laboratories have rapidly implemented several different methods for sars-cov- diagnostic testing and have also needed to send out testing to multiple reference laboratories. these complex practices have made it non-trivial to collect even the most basic information, including who is being tested and who is positive. these data are essential both to the care of individual patients and to health providers who need to design these care systems and plan for what is coming next. these data are also being reported to government agencies in multiple new manual processes. the work that has been done to build these data collection systems is extraordinary and commendable. but, for our clinical informatics and public health communities, these challenges highlight the need for developing modern, flexible clinical information systems and robust infrastructure for inter-institution data sharing. the implementation of novel clinical practices has also been notable for how much we still do not know about their clinical utility. as a consequence, there is a great need to learn about clinical utility from in-practice data. for example, the precise clinical sensitivity and clinical specificity of the sars-cov- diagnostic testing being used are currently unclear [ ] . this is critically important because false-negative results could lead to the inappropriate non-use of ppe or insufficient clinical and epidemiological monitoring. the rate of such false-negatives is also highly variable across time, as the disease prevalence changes, and across multiple patient, provider, and geographic factors. to fill in these knowledge gaps, there is a big need for the design and application of methods for estimating such parameters from in-practice data. these approaches must be robust to the many sources of bias in these kinds of retrospective data and must be applied to datasets of large enough sample sizes, to generate meaningfully precise estimates. we present here four clinical research informatics domains related to the generation, integration, and use of clinical and other data that could be leveraged in addressing the pandemic in various settings. the domains include a well-developed informatics infrastructure that encompasses a large healthcare landscape, the potential for systematically and cautiously repurposing drug treatments, the leveraging of existing clinical and biospecimen data, and the role of advanced statistical, integrative, and machine learning (ml) tools for diagnosis and treatment. one critical need to support covid- -related clinical and translational research studies is the development of informatics infrastructure that contains accurate and timely clinical data from the electronic health records of the covid- population. as a first step, healthcare institutions can create patient registries to maintain reliable lists of covid- patients and cases (e.g., confirmed, ruled out, uncertain). these data must be updated regularly (daily or several times each week) and contain a broad set of data elements representing demographics, prior medical histories, current medications, comorbidities, diagnoses, procedures, outcomes, etc. to serve a broad base of clinical investigators and scientific inquiries. to adequately code all patient data, image processing will be needed to encode salient radiological findings, and natural language processing will be needed to extract symptom onset, severity, and duration among other variables. secure informatics platforms such as integrating bench to bedside (i b ) and the shared health research information network (shrine), trinetix, and atlas play an important role in standardizing and harmonizing clinical data to common data models (cdms) including i b , patient-centered outcomes research network (pcornet), fast healthcare interoperability resource (fhir), and observational medical outcomes partnership (omop). once covid- patients are indexed within the patient registry and their clinical data has been extracted, transformed, and loaded into these frameworks, clinical researchers can execute secure, privacy-preserving, and federated queries across all participating sites using any framework to identify patients for clinical trials, generate scientific hypotheses, and conduct observational studies. both aggregate and individual-level information can be made available with appropriate data governance, ethical review, and institutional agreements. informaticians can support these efforts by ) developing technologies and algorithms for extracting, encoding, and mapping raw ehr data to emerging covid- -specific cdms, ) engaging in existing and emerging consortiums, both grass roots and nationally-sponsored efforts, across clinical and translational science awards (ctsas) and informatics networks, and ) connecting with clinicians to develop and share informatics tools and predictive models that identify clinically-formative, actionable insights from heterogeneous, temporal data. one of the major challenges with emerging diseases, such as covid- , is that evidence for effective drugs and treatments is sparse. while vaccine development is important, vaccines are only helpful to prevent individuals from becoming infected in the first place. for those that have covid- , the main strategy for treatment with drugs (while the disease is still emerging) is to reuse those that have been approved for other purposes. there are several drugs that may therapeutic use in covid- , namely: hydroxychloroquine sulfate, chloroquine phosphate, remdesivir, carfilzomib, eravacycline, valrubicin, lopinavir and elbasvir. these medications were designed for treatment of various diseases, including lupus, malaria, cancer and hiv. therefore, the use of these medications to treat covid- is termed 'drug repurposing' and one avenue for studying the potential for a drug to be repurposed is through informatics. informatics methods have been developed for both drug repurposing and pharmacovigilance (studying the adverse effects of a drug). the advantage of using existing ehrs for studying drugs as candidates for drug repurposing is that it enables risk assessment profiles to be generated for each candidate drug. since the drugs have been prescribed previously during routine clinical care, it is possible to study their effects on human health in a variety of situations that may not have been included in the original clinical trials. for example, the birth and pregnancy outcomes following drug exposure can be assessed using ehrs for drugs potentially useful in treating covid- , such as hydroxychloroquine. this is important as the hydroxychloroquine clinical trials for covid- specifically exclude pregnant women from enrolling in their studies. informatics methods can also be designed, which use more sophisticated machine learning and artificial intelligence methods to study the effects of medication exposure during pregnancy on fetal and maternal outcomes [ ] . with the aggregation of clinical and medication data from ehrs, along with the recruitment of covid- positives and negatives for genetic studies (as described above), there is an opportunity to explore genetic data in combination with this ehr data to improve our understanding of the covid- disease's severity and outcomes. early research has suggested that individuals, who have medical conditions such as heart disease, diabetes, obesity, or asthma, may be at higher risk for severe disease and/or worse outcomes from covid- . additionally, early data suggests that some medications such as ace-inhibitors, angiotensin release blockers (arbs), or non-aspirin nonsteroidal anti-inflammatory drugs (nsaids) may be linked to worse health outcomes due to covid- . however, these reports are primarily based on small, observational datasets without rigorous, epidemiological study designs. as such, these associations are met with much controversy in the literature. with the accumulation of covid- positives and negatives, along with access to ehr data, including comorbid conditions and medications, researchers will be able to develop more thorough studies of which medical conditions are associated with poorer covid- outcomes and/or which medical conditions place individuals at higher risk for hospitalization due to covid- . additionally, if these data are paired with genetic data from ehr-linked biobanks, we may be able to determine if some of these differences in covid- severity and/or outcomes related to comorbidities and medications are also related to host genetics. fortunately, there are several efforts to establish data-sharing consortia that provide an opportunity for informaticians to assist with analyses. for example, the consortium for clinical characterization of covid- by ehr, or ce (https://covidclinical.net/), has released summary-level covid- data from several countries including france, germany, italy, singapore, and the united states along with a preprint of the initial analyses [ ] . presently, there is much to be learned regarding how best to treat covid- patients when sufficient resources are available, as well as how to optimize operational decisions such as the triage of patient testing and care when they are not. as accessible, cleaned, and structured ehr data become available for covid- patients at both the institutional and multi-site consortium levels, there will be increased opportunity to apply machine learning to better understand and make risk predictions on a variety of clinically and operationally relevant outcomes. the accessibility of data science and ml packages (e.g. pandas, scikit-learn, and tensorflow python libraries), paired with widely available high-powered computational hardware offers significant opportunity for researchers to get involved in data analysis and modeling. however, many caveats need to be taken into consideration in order to develop and apply effective, rigorous ml analysis pipelines for replicable covid- investigation. some key considerations and targets of research include: ( ) feature engineering, transforming raw data into features (i.e. variables) that ml can better utilize to represent the problem/target outcome, ( ) feature selection, applying expert domain knowledge, statistical methods, and/or ml methods to remove 'irrelevant' features from consideration and improve downstream modeling, ( ) data harmonization, allowing for the integration of data collected at different sites/institutions, ( ) handling different outcomes and related challenges, e.g. binary classification, multi-class, quantitative phenotypes, class imbalance, temporal data, multi-labeled data, censored data, and the use of appropriate evaluation metrics, ( ) ml algorithm selection for a given problem can be a challenge in itself, thus strategies to integrate the predictions of multiple machine learners as an ensemble are likely to be important, ( ) ml modeling pipeline assembly, including critical considerations such as hyper-parameter optimization, accounting for overfitting, and clinical interpretability of trained models, and ( ) considering and accounting for covariates as well as sources of bias in data collection, study design, and application of ml tools in order to avoid drawing conclusions based on spurious correlations. advanced tools may be necessary to deal with data analytic challenges, properly analyze these data, and accurately extract the knowledge embedded in them. some key challenges include: ( ) accounting for correlation structure induced by multi-level, spatial, and longitudinal designs, ( ) adjusting for biases emanating from the observational data using causal approaches, ( ) accounting for privacy-induced limitations on the resolution of data that can be shared, and ( ) discovering and characterizing interpatient heterogeneities in incidence, progression, or response through stratified or latent class models. some of these challenges can be handled by aptly chosen existing methods, while others require new methodological development. the covid- crisis and the extensive data resources that it will produce will provide an excellent opportunity to develop such methods, including privacy-preserving integrative analytical tools as well as advanced causal inference tools that also account for these other data complexities. we present here two related approaches to using informatics solutions, which directly involve the public who are not physically situated within a healthcare setting. the first focuses on using smartphones and other technology for educating the public about the pandemic and ways to avoid infection as well as monitoring, and the second explores the use of sensors in this domain. consumer health informatics, focusing broadly on tools and systems that engage and empower patients and more general health consumers in health delivery and decision making processes, has a substantial role to play in the context of a pandemic. specific areas that consumer informatics researchers and system designers can target include consumer education, self-triage, monitoring, and social engagement. in a time when behavioral guidelines are continuously adjusted based on new data, consumer education is essential to conveying and disseminating actionable and timely information. patient portals and other web sites can provide educational content that can be tailored to individual information needs as well as literacy and health literacy levels. furthermore, systems can include an interactive component that can facilitate decision support and selftriage. one such example is a patient portal for self-triage and scheduling that was created at the university of california san francisco to enable asymptomatic patients to report exposure history and for symptomatic patients to be triaged and paired with appropriate levels of care [ ] . the system is already being used extensively and performs with high sensitivity in recommending emergency-level care for symptomatic patients. it also prevents unnecessary visits. tools that have been traditionally used for patient monitoring at home and the community can also be useful in generating data that provide insight into disease spread and health needs. an example is that of a smart thermometer vendor that has created an app which allows users to record their temperature and other symptoms with a health insurance portability and accountability act (hipaa) compliant platform; data are aggregated and demonstrate how the virus moves from one county to another, providing a detailed visualization map that highlights areas with an unusually high number of recorded prevalence of fever (https:// healthweather.us/). other mobile health tools that track aspects of daily living including activity levels, sleep quality, or symptom self-management can facilitate better monitoring of health and wellness and potentially lead to effective symptom management at an individual level, and contribute to disease surveillance at a population level. examples include activity tracker data that can inform surveillance of social distancing patterns, and home spirometer and pulse oximetry data that can generate a trajectory of symptom progression in various communities. finally, in times of "social distancing", vulnerable populations such as older adults living alone are at greater risk of increased social isolation, which is often referred to as a silent epidemic and great health risk [ ] . digital tools have the potential to connect individuals for the delivery of social services, and creation of virtual peer support groups and connected communities including friends and family members. this current pandemic has highlighted the need for accessible and secure tools that may include video-conferencing, synchronous and asynchronous communication, and even more sophisticated features such as virtual reality and augmented reality, designed for audiences with diverse abilities with the goal to promote social connectedness in times of physical distancing. smartphones and other wearable smart devices contain research-grade sensors that are capable of shedding light on at least a subset of covid- symptoms which include fever, fatigue, dry-cough, and shortness of breath. for example, the temperature recorded by fingerprint sensors, which are now standard on most modern smartphones, has previously been used to successfully predict fever [ ] . in addition, activity sensors such as the accelerometer have been used to detect fatigue. while high resolution computed tomography (ct) images of a patient's lung may provide a more reliable indicator of infection, the high cost and low scalability make this approach infeasible to apply widely at the general population level. on the other hand, smartphones are currently pervasive with high penetrance even in low and middle-income countries and their high-quality sensor data can be used at next to no cost to measure a subset of important covid- symptoms as a screening tool to identify individuals that may require more extensive evaluation or testing. we present here six considerations of the role of public health informatics in the covid- pandemic. these represent a broad range of topics, from information systems for the monitoring and dissemination of accurate information to the public, to leveraging existing evidence currently available in a huge corpus of virus infection-and pandemic-related research, to building more realistic models of disease risk, spread, and effect of societal interventions, to as-yet poorly understood post-pandemic effects on public health. a critical need for any strategy that addresses covid- is adequate disease monitoring. at the level of cases and deaths, several efforts around the world have arisen to maintain and display official counts, including by researchers at johns hopkins university (https:// coronavirus.jhu.edu/map.html) and reporters at the new york times (https://www. nytimes.com/interactive/ /world/coronavirus-maps.html). these and other efforts rely on reports obtained from heterogeneous sources, many of which capture and store data differently, requiring that informaticians process and display data effectively. case and death counts are helpful and widely used by healthcare systems, policy makers, governmental institutions, and the general public. however, they are notoriously biased given the differing availability and use of lab-based tests to determine covid- case status at various locations. more comprehensive efforts to track the true impact of covid- necessitate appropriate wide-scale testing of sars-cov- . knowledge of who carries the virus regardless of symptom or disease status enables efficient prevention of further transmission, the proper identification of risk factors that lead to divergent symptoms, and adequate preparation of healthcare systems to treat patients who are carriers while minimizing risk to providers and patients who have not been infected. design and deployment of population-level testing should be a primary goal for the effective containment of covid- . in conjunction with apps developed by informaticists, contact tracing along with case isolation can proceed effectively to control outbreaks [ ] . such efforts are thought to have curtailed the spread of covid- in singapore and south korea. because it is unlikely in countries like the u.s., that the federal or local governments, or many citizens would use contact tracing without ensuring individual-level data is safeguarded, various informaticists are engaged in efforts to create privacy-preserving contact tracing apps. sars-cov- containment was not successful in most countries, due in part to lack of appropriate wide-scale testing which contributed to its undetected transmission. ultimately, nothing can replace appropriate lab-based viral testing to understand disease transmission, but informatics solutions are helpful to partly overcome testing inadequacies. in the u.s., canada, and mexico, covid near you (https://covidnearyou.org/) is a citizen participation platform via which any person can contribute their current health status as it relates to covid- symptoms and test results. aggregation of this individual-level data is being used to track population-level health in real-time. other data that can be used to fill monitoring gaps includes search engine data (e.g., google queries for covid- -related terms), and to a lesser extent, social media data (e.g., twitter posts related to . informaticists are leading and contributing to such efforts around the world. as results of sars-cov- tests, along with serological assays to detect its seroconversion, become more widely available, retrospective studies can proceed to more accurately determine how covid- spreads and how many true cases existed prior to widespread testing. informaticians can participate in these efforts that require accounting for test characteristics (sensitivity/specificity) and comparing the characteristics of patients who were actually tested versus those of the underlying population. ongoing retrospective analyses such as these are critical to gain knowledge necessary to avoid future resurgences of covid- . systems for disseminating accurate information related to covid- to the public an emerging issue that concerns the prevention of covid- is the widespread dissemination of speculation, rumors, half-truths, disinformation, and conspiracy theories by means of popular social media platforms. in order for policies, guidelines, and mandates, that may be updated on a weekly or even daily basis, to reach and be adopted by the general public it is important for relevant, vetted information sources to be clearly identified and potentially pointed to in response to misleading posts. in recent years there have been many exciting efforts to combine natural language processing (nlp), machine learning, and social media scraping to monitor clinical outcomes of interest such as foodborne illnesses [ ] . there may be an opportunity to work towards adapting such informatics approaches to monitor and perhaps even combat the dissemination of 'bad' information through automated responses that redirect individuals to sources identified as reliable within the scientific community. rule-based systems such as 'expert systems' could be combined with nlp technologies to construct such monitoring and response frameworks. equally important is the consumer health informatics task of developing clear, concise, and easily navigable informational resources for covid- , that summarize up-to-date information and guidelines but also link summary information back to relevant primary sources, attempt to quantify the certainty/ reliability of available information, and offer explanations of reasoning whenever such information or guidelines need to be updated. the spread of infectious diseases such as covid- provides a unique opportunity to assess the regional spread and progression of disease at a population level. differences in pathogenic mechanisms of different diseases responsible for past pandemics imply that the spread of covid- may not be completely predictable based on the observing historical rates of disease transmission. data on the cumulative number of covid- cases is available at country/regional/city levels and by studying the progression and spread of disease in regions affected close to the time of the initial outbreak, meaningful projections of infection rates can be made for areas which will be affected later. for example, by modeling daily regional cumulative covid- cases, regional differences in the trends can illuminate the comparative effectiveness of different policy decisions and can identify countries and policies that have succeeded in slowing the rate of covid- spread, providing evidence for the adoption of effective public health policies by areas still in the early phases of the pandemic. presenting this information to the public using data visualization methods in an important informatics activity. synthesizing evidence to understand covid- origins, spread, and prevention as of april , , there are more than manuscripts published or posted at pubmed, biorxiv, and medrxiv on covid- from researchers all over the world (https://www.ncbi.nlm.nih.gov/research/coronavirus/). these manuscripts cover a wide spectrum of important topics that can help us to understand the critical aspects of clinical and public health impacts of covid- , including the disease mechanism, diagnosis, treatment, prevention, viral infection, replication, pathogenesis, transmission, viral host-range, and virulence. on the other hand, the amount of information is increasingly overwhelming for stakeholders, policymakers, researchers and interested parties to comprehend. a systematic review, which is a type of literature review that uses systematic methods to collect secondary data and critically appraise research studies, can be useful in synthesizing the existing evidence of covid- related research findings. in particular, meta-analysis plays a central role in the systematic review in quantitatively synthesizing evidence from multiple scientific studies which address related questions. manual literature review is time consuming and, more importantly, it is challenging to keep up-to-date with the rapidly increasing volume of literature. medical informatics tools can improve the efficiency and scalability of up-to-date evidence synthesis for covid- related research. for example, clinical natural language processing (nlp) tools can be used for literature screening and information retrieval. software such as abstractr [ ] [ ] [ ] and distillersr (https://www.evidencepartners.com/) has been used to reduce manual effort in literature screening. beyond literature screening, distillersr is also a useful tool for the management of the multi-step workflow of systematic review process. recently, distillersr made its tool freely available for systematic reviewers and researchers to conduct systematic reviews related to covid- . for meta-analysis, tools such as comprehensive meta-analysis (cma) (https://www.meta-analysis.com/), revman (https://training.cochrane.org/online-learning/core-software-cochrane-reviews/ revman), and macros in stata (https://www.stata.com/), are available for standard metaanalyses. however, for covid- related research, more sophisticated methods are needed in order to address unique features related to this topic. for example, the quality of the reported findings in the above-mentioned manuscripts is expected to be highly heterogeneous, especially for those manuscripts that have not been peerreviewed. it is critically important to properly account for such heterogeneity across studies. furthermore, the reported findings may be subject to more severe publication bias and outcome reporting bias [ ] , as the analysis of the data and reporting of the analysis results are likely to be based on different protocols. visualization tools, sensitivity analyses, and inference based on bias correction models can be useful in evaluating the quality of the evidence [ ] [ ] [ ] [ ] [ ] [ ] [ ] . in addition, novel visualization tools, such as the tornado plot in a cumulative meta-analysis [ ] , will be valuable for presenting how the cumulative evidence on answering a covid- related question evolves over time. r packages including 'meta', 'metafor', 'metasens', 'netmeta', 'mvmeta', mada' and 'xmeta' are useful for advanced meta-analyses with these needs. finally, online platforms for meta-analysis, such as programs with shiny interfaces, are in great need for offering convenience to covid- researchers in summarizing and synthesizing results. advanced, more realistic models of disease spread to guide policymaking differential equation-based epidemiological models such as the susceptible-infected-recovered (sir) or susceptible-exposed-infected-recovered (seir) models and their variants are key workhorses for studying infectious disease dynamics. these models have been widely used in making projections and informing policy-makers in constructing mitigation strategies for the disease. one weakness of these models is that they treat individuals in a given population as homogeneous, with constant risk rates, exposure rates, infection rates, and recovery/death rates throughout the larger group. this is a gross oversimplification which is a primary factor of the models' limited predictive accuracy. statisticians have been engaging in covid- efforts with statistical models using functional data or time series modeling techniques. these models often use covariates or latent factors to account for population heterogeneity and provide uncertainty quantification, thus improving on a weakness of the seir models. however, these models do not present the dynamic infectious disease process which may limit their interpretability and accuracy in forecasting. one key area of quantitative research that can emerge from this covid- crisis is hybrid epidemiology-statistical models. that is, models based on sir or seir frameworks that stochastically show the transition probabilities as differing according to person or environmental covariates, accounting for clustering effects, and effectively propagating uncertainty in the forecasting. these can combine the strengths of each type of model, and given the broad availability of large scale data on mobility, density, demographics, etc. that vary in different communities, they can produce much more realistic models and more accurate projections to guide policymaking. the covid- pandemic has resulted in unprecedented disruption to the healthcare system. in addition to understanding the direct health impacts of the disease, there is a public health need to understand the secondary effects of covid- -related healthcare disruption on access to and timeliness of care for other urgent conditions, and resultant effects on health outcomes. prioritizing healthcare resources for covid- patients and efforts to depopulate healthcare settings in order to reduce healthcare-related disease transmission has resulted in reduced access to care for patients across the spectrum of clinical need and severity including delayed access to surgery for cancer patients, organ transplant recipients, and others with time-sensitive conditions. public health informatics can play an important role in informing our understanding of how the effects of healthcare disruption propagate across a community, affecting access to care, and population health. answering questions about the effect of healthcare disruption on population health requires three components: ( ) access to data on healthcare utilization and outcomes, ( ) data on timing and types of public health and hospitallevel interventions, and ( ) causal inference methodologies that support our ability to draw conclusions about the causal effects of these interventions. data on health care utilization and outcomes can be obtained from a variety of sources including individual and multi-institutional ehr data and claims databases. data on public health interventions are already being compiled by researchers, including national and international databases of policy changes (https://is.gd/cqs th, https://is.gd/lvvuiz, https://is.gd/ mlcu i). finally, disentangling the causal impacts of covid- itself; interventions at the local, state, and federal level; and interventions and innovation at the individual health system level requires the rigorous implementation of study designs and analytic methods for causal inference. a number of techniques in common use in health services and econometrics research can be harnessed for this purpose including interrupted time series and difference-in-difference designs [ ] . the total number of users of social media continues to grow worldwide, resulting in the generation of vast amounts of data. popular social networking sites such as facebook, twitter, and instagram dominate this sphere. about million tweets and . billion facebook messages are posted every day (https://www.gwava.com/blog/internet-data-created-daily). a pew research report (http://www.pewinternet.org/fact-sheet/social-media/) states that nearly half of adults worldwide and two-thirds of all american adults ( %) use social networking. the report states that of the total users, % have discussed health information, and, of those, % changed behavior based on this information and % discussed current medical conditions. advances in automated data processing, machine learning, and nlp present the possibility of utilizing this massive data source for biomedical and public health applications, if researchers address the methodological challenges unique to this media. when events such as the covid- pandemic sweep the world, the public turns to social media. while there is a general belief that most of the content is not useful, adequate collection, filtering, and analysis could reveal potentially useful information for assessing public sentiment. furthermore, given the delay and shortage of available testing in the united states, social media could provide a near real-time monitoring capability (e.g. the penn covid- u.s. twitter map, https://is.gd/l gga), giving insights into the true burden of disease. preliminary work in this direction is under review. the archived version of the paper, with a training dataset and annotation guidelines as supplementary material, is available [ ] . although social media text mining research for health applications is still incipient, the domain has seen a surge in interest in recent years. numerous studies have been published of late in this realm, including studies on pharmacovigilance [ ] , identifying user behavioral patterns [ ] , identifying user social circles with common experiences (like drug abuse) [ ] , monitoring malpractice [ ] , and tracking infectious/viral disease spread [ , ] . population and public health topics are most addressed, although different social networks may be suitable for specific targeted tasks. for example, while twitter data has been utilized for surveillance and content analysis, a significant portion of research using facebook has focused on communication rather than lexical content processing [ , ] . for health monitoring and surveillance research from social media, the most common topic has been influenza surveillance [ , ] . from the perspective of informatics and nlp, proposed techniques have typically been in the areas of data collection (e.g., keywords and queries) [ , ] , text classification [ , ] , and information extraction [ ] . while innovative approaches have been proposed, there is still a lot of progress to be made in this domain. effective utilization of the health-related knowledge contained in social media will require a joint effort by the research community, and bringing together researchers from distinct fields including nlp, machine learning, data science, biomedical informatics, medicine, pharmacology, and public health. the knowledge gaps among researchers in these communities need to be reduced by community sharing of data and the development of novel applied systems. the covid- pandemic presents a myriad of challenges and opportunities for research across virtually every scientific discipline, and biomedical informatics is no exception. from the molecular and genetic sciences to population health, researchers in the five domains of biomedical informatics stand to make substantial contributions to addressing these challenges. we hope, through the numerous examples of research we have considered in this editorial, informatics researchers and practitioners can see possible avenues for their work. there is no dearth of opportunities related to covid- for those working in informatics, and it is our hope that informaticians will vigorously explore these as they arise. furthermore, we hope that those who are not informaticians will appreciate the contributions that informatics researchers can bring to their respective fields as we all seek to address the covid- pandemic and its effects around the world. the covid- vaccine development landscape diagnostic testing for severe acute respiratory syndrome-related coronavirus- : a narrative review laboratory testing of sars-cov, mers-cov, and sars-cov- ( -ncov): current status, challenges, and countermeasures temporal dynamics in viral shedding and transmissibility of 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record-derived covid- clinical course profile: the ce consortium. medrxiv rapid design and implementation of an integrated patient self-triage and self-scheduling tool for covid- national academies of sciences e. social isolation and loneliness in older adults: opportunities for the health care system transparent and flexible fingerprint sensor array with multiplexed detection of tactile pressure and skin temperature machine-learned epidemiology: real-time detection of foodborne illness at scale. npj digital med toward systematic review automation: a practical guide to using machine learning tools in research synthesis semi-automated screening of biomedical citations for systematic reviews deploying an interactive machine learning system in an evidencebased practice center: abstrackr publication bias in meta-analysis: prevention, assessment and adjustments meta-analysis, funnel plots and sensitivity analysis a sensitivity analysis for publication bias in systematic reviews: statistical methods in medical research bias in meta-analysis detected by a simple, graphical test the case of the misleading funnel plot maximum likelihood estimation and em algorithm of copas-like selection model for publication bias correction funnel plots for detecting bias in meta-analysis: guidelines on choice of axis misleading funnel plot for detection of bias in meta-analysis cumulative meta-analysis of therapeutic trials for myocardial infarction designing difference in difference studies: best practices for public health policy research a chronological and geographical analysis of personal reports of covid- on twitter towards internet-age pharmacovigilance: extracting adverse drug reactions from user posts to health-related social networks the role of facebook in crush the crave, a mobile-and social media-based smoking cessation intervention: qualitative framework analysis of posts an exploration of social circles and prescription drug abuse through twitter malpractice and malcontent: analyzing medical complaints in twitter national and local influenza surveillance through twitter: an analysis of the - influenza epidemic you are what your tweet: analyzing twitter for public health please like me: facebook and public health communication facebook advertising across an engagement spectrum: a case example for public health communication using social media to perform local influenza surveillance in an inner-city hospital: a retrospective observational study evaluating google, twitter, and wikipedia as tools for influenza surveillance using bayesian change point analysis: a comparative analysis phonetic spelling filter for keyword selection in drug mention mining from social media scoping review on search queries and social media for disease surveillance: a chronology of innovation text classification for automatic detection of e-cigarette use and use for smoking cessation from twitter twitter catches the flu: detecting influenza epidemics using twitter pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations not applicable. all authors contributed equally to the writing and editing of the editorial. all authors read and approved the final manuscript. not applicable.availability of data and materials not applicable.ethics approval and consent to participate not applicable. not applicable. the authors declare that they have no competing interests. key: cord- -t i tf d authors: musto, richard; macdonald, judy; ulrich, anne; fonseca, kevin title: health services restructuring in alberta and the pandemic influenza—an untimely concurrence date: - - journal: healthc manage forum doi: . / sha: doc_id: cord_uid: t i tf d in the last years, every canadian province and territory has undertaken significant health services restructuring, with the pace of change accelerating recently. when the h n pandemic influenza (pi) hit alberta in the spring of , the province had just begun a restructuring of health services of a scale unprecedented in canada. the new province-wide entity, alberta health services (ahs), was faced with mounting an effective response to a global communicable disease outbreak during a time of great organizational flux. in this retrospective, the authors reflect on challenges and opportunities presented during the ahs pi response related to the coordination of public health, laboratory services, emergency and disaster management, communications, and health services delivery. lessons learned are shared that may be helpful to other provinces and territories as they continue to evolve their systems, so that they may be better prepared to respond to an untimely event such as a pandemic. in the last years, every province and territory in canada has undertaken significant restructuring of their health services, with the pace of change accelerating recently. the emergence of rapidly spreading deadly infectious diseases, whether novel ones such as -ncov or familiar ones such as influenza, can be readily expected, although not their timing. when the h n pi hit alberta in the spring of (first alberta case was confirmed on april ), health services had just begun a restructuring of a scale unprecedented in canada. the new, province-wide entity, alberta health services (ahs), was faced with mounting an effective response to a global communicable disease (cd) outbreak during a time of great organizational flux. the pi arrived in canada just years after the severe acute respiratory syndrome (sars) did in , which had exposed not only the poor level of preparedness of the health system for an outbreak of a novel agent but also how broadly disruptive it could be in a community. the sars experience led to new investment in public health at the federal level, including mechanisms for better intergovernmental collaboration and information sharing. across the country certainly, there was much attention at the local level devoted to the development of emergency response plans for infectious diseases, and alberta was no exception. however, this continued preparedness was not prioritized in the run up to the complex restructuring of health services in alberta in - . only two reviews of the alberta experience have been published-one commissioned by the government and the other focused on surveillance. in this retrospective, the authors draw from these and their own personal recollections and reflect on challenges experienced and opportunities presented during the ahs pi response related particularly to the coordination of public health, emergency and disaster management, communications, and health services delivery. lessons learned are shared that may be helpful to other provinces and territories as they continue to evolve their systems, so that they may be better prepared in their response to an untimely event such as a pandemic. in , alberta became the first province to initiate an integration of virtually all publically funded health services when it created regional health authorities (rhas; table ). the governing boards were responsible to the provincial ministry of health and wellness (ahw) but were essentially independent of one another, and the extent to which structural and/or programmatic integration was realized within the rhas varied considerably. some formal collaboration between authorities did occur under the initiative of various professional groups (eg, the medical officers of health [mohs], critical care, and laboratory services) that reflected both historical practice and new developments. after a provincial election in , the decision was made to further consolidate the rhas as well as the three province-wide health service organizations plus ground ambulance services, into one province-wide service agency, alberta health services, with the stated intent being to achieve more standardized, accountable and integrated services. alberta health services formally began on april , ; a huge new organization with , employees, , associated physicians, a $ b budget and a new chief executive officer from another country. only a week or two earlier, cases of a novel influenza virus had been reported in mexico. the world health organization later that month declared the situation to be a public health emergency of international concern and then on june declared it a pandemic influenza. although all of the previously independent health authorities in alberta had existing emergency preparedness plans for a pandemic, they were each at different stages of refinement. alberta health services was now faced with mounting a large-scale public health response while grappling with all of the restructuring implications of becoming one provincial health organization. alberta health services emergency/disaster (e/d) response structure for wave i and wave ii of the h n pi response looked very different. although a provincial emergency/ disaster management (e/dm) program had been approved and funded early in the inception of ahs, establishment had yet to occur. challenges arose related to the coordination of multiple legacy jurisdictions with no established incident management structure, processes, or defined roles and responsibilities that would facilitate the new organization working together. for wave i, ahs' internal response was reliant upon legacy rhas' pi preparedness (including stockpiling of pi supplies), which had been organized independently, planned differently, and were at varied levels of readiness. in the absence of an ahs incident management system (ims), an ad hoc ahs emergency operations centre (eoc) was established and co-located with the ahw eoc, to facilitate sharing of information, planning, decision-making, and communication required to support a coordinated, provincial wave i response. the inter-wave period allowed ahs to develop and implement a province-wide ims (coordinated by the emergency disaster management team which is part of public health) that improved coordination and collaboration within ahs, and with government ministries, municipalities, and external agencies/industry. alberta health services ims utilized a command and control structure based on the incident command system (ics) that provided a common set of principles and tools, defined roles and responsibilities, and operating procedures enabling integration and connectivity between sites, services, zones (the five geographic subunits of ahs), external partners, and stakeholders. the ahs command and control structure included an executive policy group, ahs provincial emergency coordination centre, five zone eocs, and numerous site and service command posts, that provided strong and consistent support to operations and the frontline staff and enabled a more effective, timely and provincially collaborative management of wave ii. this ahs incident response structure stands today. alberta emergency management agency (aema) liaisons situated in provincial and municipal eocs facilitated the sharing of information and collaborative decision-making across the province and among the lead response organizations. however, as identified in the review of the alberta response to the pi by the health quality council of alberta, communications challenges remained both between ahs and ahw, and between central ahs leadership and the zones. feedback provided by zone respondents was that at times the efforts to achieve consistency across the province did not take into account local nuances of geography and resources-the "one size fits all" approach chafed. the pi response experience provided an opportunity for ahs and ahw to enhance their separate and collective performance. post pi, ahs, ahw, and aema developed a tripartite alberta pandemic influenza plan that aligned with the canadian pandemic influenza preparedness planning guidance for the health sector. alberta health services adopted an "all hazard" approach to emergency planning and management supported by a committee structure with oversight for the development of functional operational plans that are flexible and scalable and can be adapted to any situation. this structure contributed substantially to effective responses to such later emergencies as wildfires in slave lake amidst the organizational flux, pre-existing collaborations and relationships proved critical during the first wave of the response to the pi. the relationships between public health services and professionals that extended into ahw and first nations and inuit health (fnih) were relied upon heavily. the initial case management and contact follow-up of the first pi cases by the cd units was based on existing provincial seasonal influenza guidelines. a combined team from ahw and ahs quickly developed preliminary guidance documents for the pandemic strain, including a requirement for cd professionals to collect and report individual hospitalized case data through enhanced surveillance. this ensured a standardized approach and helped to inform the development of the national pandemic guidelines. the fact of the incompatibilities of the various legacy systems of the former rhas, including those of both public health and acute care, plus the repeated changes in official nomenclature of the pandemic strain, presented huge challenges to the team with resultant inefficiencies and gaps. an additional challenge that biased the available data toward the urban centres was the centralization of respiratory virus laboratory testing in calgary and edmonton, so that results from rural areas were delayed. however, the resulting situational reports were very useful in informing decision-makers and triggering interventions such as the opening of the influenza assessment centres and mass immunization clinics, plus the proactive increase in emergency and hospital staffing, and release of antiviral medications. the provincial laboratory for public health (provlab) was a key contributor to the surveillance activity. prior to the pandemic, the provlab had been transitioning from viral culture techniques to molecular-based assays that could handle greater volumes with similar labour resources and yield reported results in a fraction of the time. these preparations were timely and valuable, as the provlab was the first diagnostic laboratory in canada to provide subtype determinations for the pandemic strain, apart from the national microbiology laboratory. given their mandate to provide laboratory testing for the province for organisms that have public health implications, the provlab had been actively engaged in pandemic preparedness for fully a decade in conjunction with local, provincial, and national health authorities. it had stockpiled critical supplies estimated to be sufficient for a -month period, but with the transition to molecular-based assays and the huge volume of specimens submitted, a key infrastructure deficiency that emerged during the first wave was the need for semi-automated pipetting platforms. funds for their purchase were slow to be approved; the equipment did not arrive in time for use during the pandemic and a high incidence of sick time among staff resulted due to repetitive strain injury from the high volume of manual pipetting required. the availability of vaccine for wave ii, while welcomed, provided another set of challenges. the pre-ahs council of moh, made up of all the mohs in the province, including those from the former rhas (and now ahs), ahw, and fnih, worked collaboratively to provide guidance on measures to reduce the impact of the pi and liaised with community and ahs care providers to support the treatment of infected citizens. the group recommended targeting the vaccine to defined high-risk groups as consistent with those identified by the public health agency of canada; a slight modification mandated by ahw was that no one was to be denied vaccine. alberta had already decided to shift from a targeted to a universal program for seasonal influenza vaccination, and therefore, arrangements were in place for a greater number of community immunization clinics than in previous years. with the additional issue of the vaccine packaging ( multi-dose vials of antigen and adjuvant each) and a complicated repackaging process, it was decided that administration would be done only by public health nurses. when it became apparent (only days after the opening of the public immunization clinics) that the supply of adjuvanted vaccine was to be temporarily slowed nationally, the public health team recommended a one day closure of the clinics to permit a refocusing of the program. however, ahw made the decision to keep the clinics closed for days and then reopen to a gradual progression of high-risk groups. only quite late in the rollout of the immunization program when demand for vaccine had decreased substantially were arrangements finalized to enable pharmacists, community physicians, and paramedics and to also provide the vaccine. overall, the coverage rates of both high-risk groups and the general public were below that achieved in other provinces. notable exceptions were in children younger than years and first nations individuals living on reserves. the latter achievement was in large measure due to collaborative relationships between community leaders, fnih public health staff and local pharmacists, so that, for example, they were the first in the province to repackage the vaccine into smaller package sizes more appropriate to the settings (and incidentally, to also preposition supplies of antiviral medications in the communities). one final example of where pre-existing relationships were so helpful comes from acute care, where the provincial critical care network was active. this group anticipated that there would be a large demand for extracorporeal membrane oxygenation life support and built upon promising research from australia to acquire new equipment and develop treatment guidelines. they also, using a clinical database in use in calgary, adapted a national futility rating tool to fit their experience which enabled a more aggressive approach to care in some cases. through their established network, ventilators and respiratory therapists were deployed to several hospitals which did not otherwise have the means to provide the level of care required. the communications challenge and opportunity bears its own section because it permeates all aspects of the planning, response, and recovery from such a large and prolonged event. not only was the information to be communicated changing as the pandemic evolved but also there were multiple sources available, for example, from agencies or groups in other countries. unification of all health services under ahs clearly provided the opportunity to become the go-to authoritative source, and the manner in which the chief moh (within ahw) and the senior moh (within ahs) worked together to brief the public and health professionals was exemplary. still, issues of timeliness, accountability, and emphasis were common at all levels and between all stakeholders, contributing to errors, inefficiencies, and missed opportunities. that ahs was the lead agency most obviously responsible for responding to the pi made it an easy target for criticism in the media, which likely contributed to a risk aversion position that extended from the political to the frontlines. for example, the early huge demand for vaccine, the expectation to avoid long clinic queues, and the evolving list of eligible risk groups all combined almost paradoxically to yield lower than expected vaccine coverage and high vaccine wastage. there was much to be learned from alberta's pi experience, which may be applicable in other jurisdictions in organizational flux. some key points are: value and respect healthcare workers-they rise to the challenge. establish an organization-wide e/dm program as soon as any organizational restructuring is to be implemented. an e/dm program can focus on facilitating and coordinating the functional planning for a cohesive organizational e/d response. establish an organization-wide incident command structure within an ims that provides a command and control structure and processes to foster effective decision-making. it should also take into account relationships with the political levels locally and provincially. establish an organization-wide e/d stockpile of supplies that are critical for each department, with accompanying processes for management, approval/release, and retrieval (where appropriate) of the stockpile holdings. nurture and tap into existing collaborations and networks that cross or extend beyond the units to be amalgamated until new ones are functional. develop a communication plan collaboratively with the anticipated lead agencies that assigns appropriate roles and responsibilities and respects the diversity of the various target audiences, both within and outside of the organizations. develop coordinated surveillance systems across the new organization and with key partners with consistently defined data elements and triggers for intervention. the process of organizational change is difficult. the occurrence of an emergency or disaster, especially on the scale of a pandemic influenza, in the midst of such change tests an organization even further. the authors hope that this reflection will be of value to those charged with organizational preparedness for the "next big one." public health in the context of health system renewal in canada. background document learning from sars-renewal of public health in canada. a report of the national advisory committee on sars and public health review of alberta's response to the h n influenza pandemic. health quality council of alberta influenza: the alberta experience. alberta health services and alberta health and wellness the authors gratefully acknowledge the contributions of several colleagues, all of whom were active participants in the alberta response to the h n influenza pandemic, and who contributed variously to this paper through conversation or manuscript review or both. thanks go to dr. albert de villiers, dr. andré corriveau, dr. gerry predy, dr. david megran and dr. paul boiteau. richard musto, md https://orcid.org/ - - - key: cord- -qwinggg authors: viswanathan, ramaswamy; myers, michael; fanous, ayman title: support groups and individual mental health care via video conferencing for frontline clinicians during the covid- pandemic date: - - journal: psychosomatics doi: . /j.psym. . . sha: doc_id: cord_uid: qwinggg background: the current covid- pandemic has put an enormous stress on the mental health of frontline healthcare workers. objective: psychiatry departments in medical centers need to develop support systems to help our colleagues cope with this stress. methods: we developed recurring peer support groups via videoconferencing and telephone for physicians, resident physicians, and nursing staff, focusing on issues and emotions related to their frontline clinical work with covid patients in our medical center which was designated as a covid-only hospital by the state. these groups are led by attending psychiatrists and psychiatry residents. in addition, we also deployed a system of telehealth individual counseling by attending psychiatrists. results: anxiety was high in the beginning of our weekly groups, dealing with fear of contracting covid or spreading covid to family members, and the stress of social distancing. later the focus was also on the impairment of the traditional clinician patient relationship by the characteristics of this disease, and the associated moral challenges and trauma. clinicians were helped to cope with these issues through group processes such as ventilation of feelings, peer support, consensual validation, and peer-learning, and interventions by group facilitators. people with severe anxiety or desiring confidentiality were helped through individual interventions. conclusions: our experience suggests that this method of offering telehealth peer support groups and individual counseling is a useful model for other centers to adapt, to emotionally support frontline clinical workers in this ongoing worldwide crisis. the current coronavirus disease (covid- ) pandemic is placing an enormous emotional stress on frontline healthcare workers. [ ] [ ] [ ] [ ] psychiatrists and other mental health professionals are being called upon to address the mental health threats posed to several clinicians of different disciplines, in numbers to which they are altogether unaccustomed. never before has the mental health profession been faced with delivering such help on this scale. at the same time, the threat of contagion requires that such help be delivered from a distance via virtual means, a challenging departure from traditional psychiatric intervention. this calls for innovative service delivery. data are sparse in this area because of the short time since this devastating pandemic started. nevertheless, there are suggestions for individual interventions and systems interventions. [ ] [ ] [ ] [ ] [ ] to our knowledge, group intervention in this area has not been described in detail in the literature so far, though some systems in the usa, including ours, have begun offering them. here, we report the methods we have developed at the group and individual levels to help our peers, and describe in a qualitative manner our preliminary experience. since march , , our university hospital of brooklyn has been designated as a covid- only facility by new york state. from late march , our department of psychiatry began offering support group and individual video-conference sessions to help our frontline attending physicians, resident physicians, nurses and other healthcare professionals, and students. later we began support group conference calls by telephone for our nurses as they preferred this modality over video-conference. participation in our groups is voluntary. a support group is defined as "a group of people with common experiences and concerns who provide emotional and moral support for one another." our groups for attending physicians are organized around their roles and specialties, such as hospitalists, emergency medicine physicians, and pediatricians redeployed into adult covid units. while in the beginning we thought it might be advantageous to have separate groups for attending physicians and residents, later we relaxed that policy at the request of the attending physicians who desired their residents to be included. this has not presented any problems, probably because in this crisis they both face similar issues, and have a sense of solidarity in a desperate fight against a common enemy . in fact, attending physicians provided great solace and a calming effect to their junior colleagues. we have two facilitators per group, drawn from psychiatry faculty and residents. for the nursing group, there is also a nursing leader serving as a co-facilitator. the groups meet weekly for about minutes. in the meetings we emphasize that these are peer-support groups, encourage spontaneous expression of thoughts and feelings, and acknowledge that some may not feel ready to talk, but they can still benefit by listening. the supportive interventions that we employ are explained in the discussion section. we have also set up a system to provide individual counseling sessions to any employee or student in our medical center in a confidential manner. all licensed faculty members in our department have made themselves available during certain periods for these sessions via telehealth. our institution's employees or students can leave a voice or text message in a confidential manner at a dedicated telephone number, or send an email to a dedicated email address. senior psychiatry residents screen the messages, and schedule an appointment for the caller with a faculty clinician, based on availability and the knowledge of each clinician's areas of expertise. the faculty clinician can initiate a video conference call from the scheduling software, do a brief evaluation, provide counseling, and if necessary schedule additional sessions, issue prescriptions for medications, or make outside referrals. we estimate that about attending physicians, residents, and nurses, all frontline healthcare professionals, have participated in the group sessions, and people have used the individual sessions. some times more than one person use the same computer or speaker-phone. the number of individual sessions for a person has generally been two. both the group and individual sessions have been found to be helpful by the participants, as told to us by them in the group and individual sessions, and to their peers by them, who in turn told us. for example, two residents disclosed in their individual sessions with one of the authors (mm) that they have found both individual and group meetings helpful. a few nurses, physicians and administrators not involved with the groups have told us that they have heard from the participants how helpful the groups were. we did not collect formal measures of distress or outcome data as these were not patients or research subjects, and the interventions were done during a dire period of lifethreatening collective crisis. the individual sessions tend to be used by people who do not want to participate in support groups because the problems they are experiencing are sensitive, they want to preserve confidentiality, or their issue is of a nature or severity that cannot be adequately dealt with in a peer support group. they are also used by employees who are not frontline clinical workers. the presenting symptoms have been mostly anxiety-related, including some work deployment issues. because of the private nature of these sessions, we are not giving here details of the discussions in these sessions. in the physicians' and nurses' weekly groups the content of the discussions evolved over time. at first they focused on anxiety related to contracting covid- and fear of spreading it to one's family and friends; on the strain imposed by taking extraordinary precautions to prevent this, including social distancing and isolation from one's own family, wearing masks at home, taking care one's clothing or the places one touches do not place the family at contagion risk; and guilt over putting one's family at risk. some individuals opted not to go home at all after work, but instead stay in the hospital or a hotel or rental apartment, in order to reduce contact risk to their families. many disliked being bombarded by news and conversations about the coronavirus when they were off work. people also complained of the difficulties and discomfort imposed by having to wear full personal protective equipment (ppe) all the time for long hours in their clinical work, and the interference with their collegial relationship at work because of it. there was also anger and dismay at the shortage of ppe. people used the analogy of soldiers being sent into the battle without armor or arms. in later sessions, a prominent theme has been the threat to the intimacy of the doctor-patient or nurse-patient relationship. physicians and nurses are concerned about dehumanized interactions with patients because they wear their ppe at all times, which conceals their facial expressiveness and identifying features as a human being. they spoke of how this deprives very ill or anxious patients of the personal comforting they need from their healthcare professionals, and frightens the cognitively impaired. some are also afraid that communicating traumatic news often in quick succession is making them become numb or robotic in such interactions, and they fear an erosion of their humanity. because of institutional policies aiming to reduce the risk of contagion, they have been prevented from allowing family members to be with their loved ones in their dying moments. this has been heart-wrenching for physicians and nurses to bear, as they are used to the role of being a bridging and consoling presence between dying patients and their families. physicians and nurses also struggle with a feeling of lack of control and a sense of futility, in that with many patients they can do little to halt the progress of this disease. while attending physicians may have more experience with this clinical dilemma than trainees, it has never been on such a massive scale. exacerbating this sense of lack of control is the fact that there are very few data on prognostic factors in hospitalized covid- patients that they can rely on, for their own guidance or to reassure patients and families. many patients deteriorate unpredictably and quickly, and die. death of their own colleagues and family members of colleagues from covid resulted in intense bereavement-focused sessions. the deaths of a critical care specialist physician and an emergency department nurse, both of whom had worked in our medical center for decades and were widely beloved, were especially hard to bear. those who got covid and stayed at home for a period of time felt guilty that they were not at the frontline helping when their colleagues were overworked. people also expressed guilt about getting free food from wellintentioned donors, while they knew that many people in the community they serve were fooddeprived. people were appreciative of the enormous outpouring of community support, and the support they received from their colleagues and the institutional leadership. how do we, as mental health professionals, respond in a therapeutic manner to these themes? we utilize reflective listening, clarification, reassessment of perceptions employing socratic dialogue, and relabeling of emotions. an example: emergency physician: "the patient was dying. i knew his wife was just outside the emergency room in the waiting area. yet i could not bring her to the dying person's bedside. it tore my heart". facilitator: "so it was heart-wrenching for you that you could not do a basic humane thing, and had to let your patient die without family we encourage people to take minibreaks during their stressful work, and use brief mental relaxation strategies during the course of their work, such as the meditation outlined above. we emphasize the importance of proactively looking after one's physical and mental health, including physical exercise, sleep, healthy nutrition, recreation, and social connectedness. we advocate limited or titrated exposure to covid- media "breaking news" programming. to counteract the relentless feeling of powerlessness expressed by some physician participants, simply reminding them of the basic tenets of the doctor-patient relationship goes a long way. we urge them never to underestimate how much they help their patients and their families by their presence, commitment, and acts of kindness. we lauded one physician who in response to his patient's plaintive query "doctor, am i going to die?", said "we are going to do everything we can to treat this, to help you." although the patient did die within a few hours, there was a collective sense in the group that his physician's words provided some solace, without the physician being untruthful. we have to keep in mind that our healthcare professionals have not faced before deaths of their patients on such a massive scale in such a rapid manner. as of may , , kings county (brooklyn), new york, where our hospital is located, had recorded covid- related deaths, the highest number among all the counties in the usa. this happened in a period of two and a half months. this is bound to have a demoralizing effect. group interventions help reach a larger number of people with a limited number of mental health professionals, and can offer some additional healing elements that individual approaches do not. such therapeutic factors include sharing experiences in a peer setting, consensual validation, support and learning from peers, and building a sense of solidarity and camaraderie with fellow group members. examples are given in table . all our nurses prefer audio-only groups over audio-visual groups. some nurses have told us that they and their colleagues would not want to show their faces when they are emotionally upset "because it is not in their culture". we do not know how much of this preference has to do with differences between nursing culture and physician culture in our institution, accessibility to a private space in the work place where computer or smart phone use is feasible, or cultural issues related to demographics. even in the physicians' videoconference groups about half the participants keep their video muted (they are not seen) even though their identity is visible, and some selectively unmute their video so that they can be seen at times. because of the crisis nature of these-support groups we did not do a deeper investigation of this issue. what's most important is to honor and implement whatever format helps. as pointed out before, some people and problems require individual sessions. telehealth interventions minimize the risk of contagion to providers and participants, which is important during the covid pandemic. they also facilitate access. people can participate without losing too much work time or rest time. telehealth support groups for patients have been successfully deployed before. they would be easier to set up to help health professionals. some of the pointers other institutions can take from our experience: psychiatrists and other mental health professionals are not peripheral to this covid- crisis, but can be at the front and center, helping frontline health care professionals preserve their mental health while being effective in helping the patients and the community. both group and individual sessions need to be offered. groups work best if one member of the clinical service takes responsibility of organizing the weekly videoconference or teleconference, and serves as the group's liaison with the group facilitators. one has to be flexible with some traditional ways of running groups. some people may participate by telephone or computer audio only, and some listen without uttering a word but still seem to be benefiting by such participation. the groups need to be offered at different periods of day and evening to accommodate different work schedules. weekly groups at set times work well. the employer needs to give time for the employees to participate in these groups, recognizing that this wellness intervention ultimately helps patient care. some people prefer participating while they are on site and some others while they are off work. the sessions need to be shorter than the traditional -minute sessions, because of the time constraints imposed by conducting them during work hours. our groups typically run for about minutes. we hope that peer group support and individual interventions like these will help protect the mental health of a number of clinicians who are doing such commendable and courageous work, so that they can continue to effectively help the countless severely ill patients with covid- . other institutions can adapt these methods to their own needs. this is a significant way the field of behavioral health can assist in this moment of world crisis. conflict of interest disclosure for all the authors relevant to this manuscript: none helped me a lot with helping my mom who lives alone in california." peer support "sometimes i am so overwhelmed at work that i feel a need to decompress". group: "speak to the supervisor about being given a short-break in those situations. we will support you." mental health outcomes among health care workers exposed to coronavirus disease covid- -associated psychiatric symptoms in health care workers: viewpoint from internal medicine and psychiatry residents mental health needs of health care workers providing frontline mental health and the covid- pandemic progression of mental health services during the covid- outbreak in china covid- : peer support and crisis communication strategies to promote institutional resilience attending to the emotional well-being of the health care workforce in a new york city health system during the covid- pandemic reflections: the value of patient support groups. otolaryngol head neck surg johns hopkins university: covid- united states cases by county therapeutic factors in group psychotherapy: a review telehealth interventions delivering home-based support group videoconferencing: systematic review key: cord- -cmim lx authors: thombs, brett d.; bonardi, olivia; rice, danielle b.; boruff, jill t.; azar, marleine; he, chen; markham, sarah; sun, ying; wu, yin; krishnan, ankur; thombs-vite, ian; benedetti, andrea title: curating evidence on mental health during covid- : a living systematic review date: - - journal: j psychosom res doi: . /j.jpsychores. . sha: doc_id: cord_uid: cmim lx nan the coronavirus disease (covid- ) pandemic has disrupted the lives of people across the world by its rapid spread, high mortality, disruption of the social fabric, toll on health care systems, and devastating economic impact [ ] . fear of personal infection or infection of friends and family members is common among people exposed to any infectious disease outbreak [ ] . for covid- , there are additional fears that health care systems may be overrun and that adequate medical care will not be available for all those affected; that isolation and movement restrictions will be long-lasting with a heavy toll on mental health and well-being, social functioning, and work; and that individual and societal economic resources will be insufficient or will not recover any time soon [ , ] . there will likely be serious mental health implications from the covid- outbreak and that these could extend beyond the acute period of the outbreak for many people [ , , ] . adequately addressing mental health needs during and following covid- , as well as preparing for possible future outbreaks, requires an understanding of the nature and extent of mental health effects, factors associated with vulnerability to negative mental health outcomes, and evidence on the effectiveness of interventions that may be rapidly employed to prevent or address mental health concerns. a february review [ ] identified studies from previous infectious disease outbreaks on psychological outcomes among people quarantined after being exposed to others who had been infected, including studies from severe acute respiratory syndrome in mainland there are important limitations, however, that reduce our ability to easily apply that evidence to decision-making in covid- ; among them, ( ) few studies used validated mental health outcome measures; ( ) no studies compared outcomes during quarantine to pre-outbreak mental health data, which reduces the ability to draw conclusions about changes in mental health and associated factors; ( ) and no trials tested interventions to improve mental health symptoms during or following infectious disease outbreaks. furthermore, the scope of covid- far exceeds that of other relatively recent outbreaks, and, subsequently, the overall threat it poses is much greater. a major barrier to effectively using research on mental health during covid- , however, will likely be the large number and rapid publication of studies of variable quality, rather than a lack of evidence. as part of this, there will be challenges in rapidly separating informative evidence from evidence that may be less useful or misleading due to poor methodology, inadequate reporting, or both. a quick perusal of early journal and pre-print publications, trial registries, discussions with journal editors, and our own experience with peer review requests suggests that it will be crucial to be able to curate evidence rapidly, clearly delineate the kind of evidence that will answer pressing questions, and identify well-conducted and reported studies that can help us answer those questions. to this end, in partnership with the journal of psychosomatic research, we are launching a living systematic review [ ] to evaluate ( ) levels of mental health symptoms, prioritizing studies that assess changes in symptoms from pre-covid- or compare concurrent samples between participants with different experiences with covid- (e.g., those infected versus healthy comparison sample); ( ) factors associated with levels or changes in symptoms during covid- , and ( ) the effect of interventions on mental health symptoms during covid- . living systematic reviews [ ] are systematic reviews that are continually updated and provide ongoing access to results via online publication. they are logistically challenging, but provide value beyond conventional systematic reviews in situations where ( ) important decisions need to be made that merit the resources involved; ( ) the certainty in existing evidence is low or very low, posing a barrier to decision-making; and ( ) there is likely to be new research evidence emerging that would inform decisions [ ] . this is precisely the scenario we face with covid- . our living systematic review has been registered in the prospero prospective register of systematic reviews (crd ), and any changes to the study protocol will be registered as amendments with prospero. a protocol has been uploaded to the open science framework (https://osf.io/ csg/). studies in any language that address review questions and meet inclusion criteria will be included. a comprehensive search strategy for the review was developed in english by a health sciences librarian and translated to chinese by members of the research team. the search will be conducted in english-language databases (medline (ovid), psycinfo (ovid), cinahl, embase (ovid), web of science) and using both english and chinese search terms in the china national knowledge infrastructure and wanfang databases. search alerts will be set in each database to send the research team daily updates when new results match search terms. results will then be quickly uploaded onto a website dedicated to the project (https://www.depressd.ca/covid- -mental-health). our team will provide a narrative synthesis as evidence accumulates. as part of this, dr. sarah markham, a member of the team and an experienced patient advisor [ ] (diagnosed with anxiety and a depressive disorder) who survived a serious suicide attempt in , will provide commentary from a patient perspective. in addition, experts in mental health research and care will contribute outside reviews and commentary, which will be made public, as the review progresses. eventually, the review will undergo traditional academic peer review for publication in the journal of psychosomatic research. in evaluating evidence on the nature and level of mental health burden from covid- , we will prioritize studies that compare symptom levels or diagnoses among study participants during covid- to pre-covid- data. evidence from cross-sectional studies that report percentages of participants with scores above cutoff thresholds on commonly used symptom questionnaires is sometimes considered. conclusions that can be drawn from that type of data about mental health effects from covid- and clinical implications, however, will be limited. this is because percentages of people who score above a threshold on standardized questionnaires vary, sometimes dramatically, between populations, even in normal times. for example, the percentage of participants with scores of at least on the patient-health questionnaire- [ ] , a commonly used measure of depressive symptoms, in large, randomly selected, regional or national general population samples, has been reported as % in hong kong (n = ) [ ] ; % in germany (n = ) [ ] ; % in shanghai, china (n = ) [ ] ; % in the united states (n = , ) [ ] ; % in the province of alberta, canada (n = ) [ ] ; % in sweden (n = ) [ ] ; and % in jiangsu province, china (n = ) [ ] . even within populations from the same region, the percentage can vary dramatically depending on sample characteristics. in jiangsu province, for example, the percentage among rural residents ( %) is twice that of urban residents ( %); it is also several times higher for older adults ( % for - years; % for ≥ years) than for young adults ( % for - years). further complicating interpretation when there is not a time-based or other relevant comparator, percentages from symptom measures such as the phq- tend to dramatically overestimate prevalence that would be obtained from validated methods for ascertaining prevalence of mental health disorders, and there is too much heterogeneity between samples in the difference to correct for this statistically [ ] . ideally, investigators with pre-existing cohorts will be able to compare mental health symptoms prior to and during or after the covid- outbreak. other investigators who have recently completed relevant studies may be able to obtain permission to exceptionally contact study participants for follow-up assessments during or post-covid- . for studies that assess factors associated with levels or changes in mental health symptoms, we will include only studies with multivariable analyses. studies with cross-sectional and longitudinal designs will be eligible, although cross-sectional designs will only be included if factors assessed were present prior to the outcome (e.g., gender, preexisting medical conditions). studies with multivariable analyses that are predominated by concurrent mental health associations will be excluded, as these do not permit interpretation of directionality. in prioritizing evidence, studies with representative samples, sufficiently large sample sizes for precise estimates, an adequate number of participants per variable in models, and appropriate statistical methods will be emphasized. we will track registrations and results from randomized trials and non-randomized controlled trials that evaluate the effects of any intervention designed to improve any aspect of mental health during the covid- pandemic. as with any systematic review, evidence from trials that are registered and define outcomes prior to enrolling participants and that are well-conducted and reported will be emphasized. for all of our review questions, evidence from studies that carefully characterize study populations and participants will be the most useful. in addition to characteristics that are expected to be reported in all studies, authors should provide details on the characteristics of the covid- outbreak in the study locality during the time data were collected, considering issues such as the number of cases and deaths, the trajectory of both of these, and restrictions on social interaction and mobility. characteristics of participants should, to the extent possible, describe the degree to which they have been affected by the outbreak in terms of their own health; the health of close relations; and their risk of infection due to reasons such as having a pre-existing medical condition or working as a health care provider for infected patients. our mental health research community has the important responsibility and the opportunity to dramatically expand our understanding of how large-scale health and other crises may influence mental health. the degree to which we are able to do this and our ability to effectively apply what we learn to preventive activities and to mental health intervention depends on the quality of the evidence we generate, our ability to identify the most informative studies, and how capably we use evidence from those studies to draw conclusions. we are hoping that our living systematic review will help towards that end. bdt, ob, dbr, jtb, ma, ch, sm, ys, yw, ak, ab, and it-v contributed to the development of the living systematic review protocol. bdt drafted the editorial, and all other authors provided a critical review and approved the final version. bdt is the guarantor. ms. rice was supported by a canadian institutes of health research vanier graduate scholarship, and dr. wu was supported by fonds de recherche du québec -santé postdoctoral training fellowships. there was no funding for the project itself, and no sponsor or funder was involved in the study design; in the collection, analysis and interpretation of the data; in the writing of the report; or in the decision to submit the paper for publication. the coronavirus pandemic in five powerful charts the psychological impact of quarantine and how to reduce it: rapid review of the evidence fear in the time of covid preliminary covid- fears questionnaire: systemic sclerosis and chronic medical conditions versions the psychological effects of quarantining a city psychological interventions for people affected by the covid- epidemic living systematic review: . introductionthe why, what, when, and how patient advisory panel members the phq- : validity of a brief depression severity measure the patient health questionnaire- for measuring depressive symptoms among the general population in hong kong standardization of the depression screener patient health questionnaire (phq- ) in the general population reliability and validity of the chinese version of the patient health questionnaire (phq- ) in the general population prevalence, correlates, and misperception of depression symptoms in the united states longitudinal epidemiology of major depression as assessed by the brief patient health questionnaire (phq- andersson, depression, anxiety and their comorbidity in the swedish general population: point prevalence and the effect on health-related quality of life depression among the general adult population in jiangsu province of china: prevalence, associated factors and impacts patient health questionnaire- scores do not accurately estimate depression prevalence: an individual participant data meta-analysis all authors have completed the icmje uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that they have no competing interests. key: cord- -ib c lbi authors: koh, david; goh, hui poh title: occupational health responses to covid‐ : what lessons can we learn from sars? date: - - journal: j occup health doi: . / - . sha: doc_id: cord_uid: ib c lbi on december , the world health organization (who) received reports of pneumonia cases of unknown etiology in the city of wuhan in hubei province, china. the agent responsible was subsequently identified as a coronavirus—sars‐cov‐ . the who declared this disease as a public health emergency of international concern at the end of january . this event evoked a sense of déjà vu, as it has many similarities to the outbreak of severe acute respiratory syndrome (sars) of ‐ . both illnesses were caused by a zoonotic novel coronavirus, both originated during winter in china and both spread rapidly all over the world. however, the case‐fatality rate of sars ( . %) is higher than that of covid‐ (< %). another zoonotic novel coronavirus, mers‐cov, was responsible for the middle east respiratory syndrome, which had a case‐fatality rate of %. our experiences in coping with the previous coronavirus outbreaks have better equipped us to face the challenges posed by covid‐ , especially in the health care setting. among the insights gained from the past outbreaks were: outbreaks caused by viruses are hazardous to healthcare workers; the impact of the disease extends beyond the infection; general principles of prevention and control are effective in containing the disease; the disease poses both a public health as well as an occupational health threat; and emerging infectious diseases pose a continuing threat to the world. given the perspectives gained and lessons learnt from these past events, we should be better prepared to face the current covid‐ outbreak. of covid- (< %). another zoonotic novel coronavirus, mers-cov, was responsible for the middle east respiratory syndrome, which had a case-fatality rate of %. our experiences in coping with the previous coronavirus outbreaks have better equipped us to face the challenges posed by covid- , especially in the health care setting. among the insights gained from the past outbreaks were: outbreaks caused by viruses are hazardous to healthcare workers; the impact of the disease extends beyond the infection; general principles of prevention and control are effective in containing the disease; the disease poses both a public health as well as an occupational health threat; and emerging infectious diseases pose a continuing threat to the world. given the perspectives gained and lessons learnt from these past events, we should be better prepared to face the current covid- outbreak. coronavirus, covid- , health care, occupational health, outbreaks, public health, sars-cov- confirmed cases and over deaths spread over countries and territories. initial reports suggested that the overall case-fatality of covid- infection appeared to be approximately %. the case-fatality was much higher in the city of wuhan (currently around . %) as compared to other parts of china and the rest of the world. the disease has an estimated mean incubation period of . days ( % ci . - . ) and a basic reproductive number (ro) of . ( % ci . - . ). it is possible that people with covid- may be infectious even before showing significant symptoms. however, it is believed that those who have symptoms are the ones who are primarily causing the spread of the infection. these figures have been updated recently, with an estimated ro of between . and . for sars-cov- , incubation period of - days (mean - ) days and a mortality rate of about . %, based on a larger sample of cases. this event evoked a strong sense of déjà vu, as it has many parallels to the outbreak of sars during and . similar to covid- , sars originated during winter in china, spread rapidly all over the world affecting countries, and was caused by a zoonotic novel coronavirus. however, in comparison, sars affected far fewer people ( reported cases) but had a higher case-fatality rate of . % ( deaths). another zoonotic novel coronavirus, mers-cov, originated in the middle east in . in all, there have been reported mers-cov cases resulting in deaths (case-fatality rate, %) in countries. outbreaks of mers have been reported in hospitals in countries such as saudi arabia, jordan, and south korea. our experiences in coping with the previous sars and mers outbreaks have better prepared us to face the new challenge posed by covid- . in particular, we learnt many valuable lessons from dealing with the sars outbreak, which was an unprecedented event. the perspectives and experiences gained from managing sars, and comparisons to our responses to the covid- outbreak include the following: healthcare workers (hcws) in health care establishments include doctors, nurses, laboratory and paramedical staff, health attendants and cleaners. other than health care workers, anyone who are physically present or associated with health care institutions were at high risk of infection by sars-cov. worldwide, hcws comprised a significant % of all sars patients, but in countries such as canada and singapore, more than % of the patients were hcws. performance of certain procedures, such as intubation and nebulization of sars patients was recognized as having a significant risk of infection. however, even low-exposure situations and transient exposures to infected cases posed infection risks. there were also reports of "super-spreaders," who often were initially undiagnosed, and who spread the disease to clusters of hcws. healthcare workers are also a recognized high-risk exposure group to sars-cov- . as of march , more than hcws have been infected in china, with deaths reported. a covid- "super-spreader" was reported in a wuhan hospital. the patient presented with abdominal symptoms and was initially admitted to a surgery department, resulting in over hcws being infected. in many other countries, currently thousands of hcws have been infected, and hundreds have died, though not all have occurred because of occupational exposure. this is because household and community transmission have also played a role in the infection of hcws. in general, hcws are now better equipped and better trained and prepared with infection control techniques as compared to the time of sars. the number of hcws as a proportion of all cases of covid- appears to be smaller and hcws comprise less than % of cases. several factors may have contributed to this. for example, in singapore, there are established occupational medicine departments to protect hcws in major singapore government hospitals in . in comparison, no such departments existed in . to reduce the risk of occupational exposure to infection, personal protective equipment (ppe) have been stockpiled, hcws are mask fitted, repeated training in infection control techniques have been given, and strict adherence to infection control protocols is mandated. there is also extensive daily monitoring of health among staff. world health organization has developed several technical guidance documents regarding covid- for hcws, including rights, roles and responsibilities of hcws which comprises key considerations for safety and health. as part of a who preparedness and response initiative, they have also established a risk assessment tool that is to be used by health care facilities to determine the risk of sars-cov- infection of all hcws who have been exposed to a covid- patient. this tool also provides recommendations for appropriate management of these hcws, according to their infection risk. however, the magnitude of the pandemic, with its explosive increase in number of infected patients requiring treatment in health care facilities, has resulted in health care establishments being overwhelmed in many countries. there are shortages of ppe such as n masks and surgical masks for health care workers, and ventilators for patients even in the more developed countries with robust health care systems. there has also been a profound loss of trust in authority with perceptions that policy is guided more by scarcity | of opinion than science. in the developing countries, the situation is even more dire. during the sars outbreak, hcws in affected countries worked under great stress and in constant fear. besides being exposed to the virus, they experienced fatigue, burnout, stigma and were at risk for physical and psychological violence. the need to protect themselves by having to wear uncomfortable ppe at all times, the necessity to monitor body temperature several times a day, enforced restriction of movements within and between health care establishments and having to work long hours in physically separate teams were common features of health care work. about a third ( %- %) of hospital workers in toronto experienced a high degree of distress, as measured on the impact of event scale. in singapore, over ten thousand hcws in nine health care settings were surveyed during the sars outbreak. many reported feeling more stressed at work, experiencing an increase in workload and having to work overtime. most respondents agreed that "people close to me are worried for my health," and that "people close to me are worried they might get infected through me." in addition, there was also fear and stigmatization of hcws and their family members from the public because of their occupation. (table ) . during this covid- outbreak, hcws are similarly working under extreme conditions over long hours. many hcws have fears for their personal health and many have their family members worried for them. the need for management of stress and fatigue among hcws is important and should be recognized and provided for. at the same time, stigmatization and ostracization of hcws have been witnessed. due to their occupation, hcws are shunned and harassed by some members of a fearful public. these reactions arise largely from ignorance and anxiety. such adverse reactions have also been directed towards other groups of people, such as those under quarantine, or persons of specific races and nationalities. the cdc has identified persons of asian descent, people who have travelled and emergency responders or healthcare professionals as groups who may be at risk of being stigmatized. on the other hand, there have are also been positive reactions from the public and strong expressions of gratitude and support for hcws. many members of the public do appreciate the hcws' dedication to work and the sacrifices they make and there has been a general outpouring of support from the public for hcws in many countries. besides the obvious stressors of working long hours under conditions of risk of infections, and separation from their families and loved ones another mental health challenge faced by health care workers is the dilemma they face when deciding how to ration scarce health care resources to patients. in countries such as italy, where the number of patients who need ventilators outnumbered the available equipment, health care workers were forced to make uncomfortable life or death decisions. the lack of resources contributed in part, to the high covid- death rate in italy. this is unfortunately another challenge seen in covid- outbreak that was not encountered during the sars outbreak. mental health support for hcws can be provided via multidisciplinary mental health teams, which include psychiatrists, psychiatric nurses, clinical psychologists, and other mental health workers. regular, accurate and clear communication updates should be provided in order to allay prevailing uncertainty and fear that the hcws are experiencing. hcws caring for covid- patients may also require regular clinical screening for depression and anxiety. however, specific mental health issues may need to be managed by different approaches. for example, one possible solution to help clinicians directly involved in managing critically ill patients from making ethically difficult choices such as deciding who receives ventilator care, is to form a triage committee. such a committee can comprise volunteers, including respected clinicians and leaders, among their peers. the committee can be tasked to make these difficult choices, in order to spare the frontline clinicians from the dilemma of rationing scarce medical resources. severe acute respiratory syndrome was spread to hcws mainly by direct mucous membrane contact with infectious respiratory droplets and exposure to contaminated surfaces. prevention and control measures were early detection and isolation of cases and quarantine of exposed members of the public. these measures were effective. for example, secondary cases of sars were minimal when the source cases were isolated within days of onset of symptoms. however, if isolation was delayed, the number of secondary cases increased rapidly. for hcws, effective preventive measures involve wearing of gloves, gowns, eye protection, n masks, practising good personal hygiene, and self-monitoring for early disease symptoms and early treatment. although the implementation of such measures on a massive scale was initially challenging, most health systems and hcws eventually coped. however, sustaining such extensive preventive measures over prolonged periods was difficult. for the covid- outbreak, we have witnessed extensive contact tracing and quarantine measures implemented in major chinese cities, affecting millions of people. implementing such measures requires advance planning of suitable locations for quarantine, giving support to patients who are in quarantine and being strict to those who break the laws by enforcing penalties. health care resources have also been marshalled and mobilized on an unprecedented scale to respond to those who require treatment. however, a current challenge is the worldwide shortage of medical supplies such as ppe and medical equipment such as ventilators, and even test kits for diagnosis. advice given for the general public for covid- has seen a greater emphasis placed on hand washing, personal hygiene (such as not touching the face with contaminated hands), respiratory hygiene (eg, practising cough etiquette by coughing or sneezing away from others or into the sleeves and wearing masks if feeling unwell), social distancing, avoidance of crowds, travel advice and advice that persons who are well need not wear masks. due to the limited supply of masks, the initial general advice has been for masks to be worn by ill patients and people who have close contact or who are looking after ill patients. for the general public, information on types of masks to wear (surgical masks would suffice, rather than n masks), the proper way of wearing and disposing of masks in a safe and socially responsible manner has been given. however, it is important to note that such information continues to evolve. the latest guidelines from centers for disease control and prevention (cdc) in april recommend that masks or face coverings should be worn by the public when they go out. one reason for the change in advice is the recognition that there may be asymptomatic cases who might spread infected respiratory droplets to other members of the public if they are not wearing face coverings or masks. social distancing has been implemented as part of the efforts to "flatten the curve". the "curve" refers to the projected number of people who will contract covid- over a period of time. by implementing community isolation measures, the daily number of disease cases can be kept at a manageable level for medical providers, hence it may help lessen the healthcare burden. as the situation evolves, some countries are employing more restrictive measures such as travel bans and lockdowns. it was reported that by the end of march , more than countries had instituted either a full or partial lockdown, impacting billions of residents. severe acute respiratory syndrome was widely viewed as a public health threat but was less appreciated as an occupational disease. among the occupational groups at risk were hcws, animal and food preparation handlers, transport workers (ranging from flight attendants to taxi drivers), and laboratory researchers working with the sars-cov. for example, more than a third of the early cases of sars (pre-february ) occurred in persons who handled, killed, or sold food animals, or in those who prepared or served food. thus, in addition to public health measures, an appropriate occupational health response is also necessary. in the current covid- outbreak, diverse occupational groups are recognized to be at risk. for example, in singapore, % of the first locally transmitted cases were probably related to occupational exposure. the workers who are in the hospitality, retail, food and beverage industry who served infected tourists, transport workers, multinational company workers who attended an international meeting, a domestic worker and even a security officer who served quarantine orders were all at risk. these occupations were not covered by the occupational health legislation of singapore in , which was the factories act. however, in , the workplace safety and health act in singapore applies to many of these workers. thus, if and when the disease is officially recognized as an occupational disease, these workers (and not only factory workers) will be covered by the health and safety law. a major concern of many workers is the fear of job losses or loss of income. this is apparent from the economic impact of covid- where in many countries, non-essential services have been halted, and many people stay at home and avoid going out for shopping or entertainment. self-employed workers, workers in a gig economy, and those working in entertainment, hospitality, tourism and travel sectors, to name a few, will be threatened with loss of income and job losses. in order to manage the economic fallout, many governments have provided stimulus packages to assist such groups. who statement regarding cluster of pneumonia cases in wuhan, china. detai l/ - - -state ment-on-the-secon d-meeti ng-of-the-inter natio nal-healt h-regul ation s-( )-emerg ency-commi ttee-regar ding-the-outbr eak-of-novel -coron aviru s-( -ncov) who. coronavirus disease coronavirus: covid- has killed more people than sars and mers combined, despite lower case fatality rate 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protective equipment during the covid- pandemic protect our healthcare workers the experience of the sars outbreak as a traumatic stress among frontline healthcare workers in toronto: lessons learnt risk perception and impact of severe acute respiratory syndrome (sars) on work and personal lives of healthcare workers in singapore: what can we learn? med care timely mental health care for the novel coronavirus outbreak is urgently needed. lancet psychiatry. cdc_aa_ refva l=https % a% f% fwww.cdc.gov% fcor onavi rus% f -ncov% fsym ptoms -testi ng% fred ucing -stigma.html. accessed managing mental health challenges faced by healthcare workers during covid- pandemic facing covid- in italy-ethics, logistics, and therapeutics on the epidemic's front line the toughest triage: allocating ventilators in a pandemic covid- ) advice for the public use of cloth face coverings to help slow the spread of covid- why outbreaks like coronavirus spread exponentially, and how to "flatten the curve coronavirus: a visual guide to the world in lockdown occupational risks for covid- coronavirus outbreak: the role of companies in preparedness and responses companies and occupational health departments may also play a role in the national and international pandemic response and in managing such concerns among workers under their care. since august , after the containment of sars, new diseases have periodically surfaced to confront the world on a regular basis. these include the appearance of viruses eg, mers-cov, various influenza viruses eg, h n (swine flu), h n (avian influenza), h n , zika virus, and the deadly ebola virus. such ongoing and sporadic events remind us that it is a certainty that emerging infections will continue to remain as real threats to our world, and we should be ever vigilant and ready to respond. https://orcid.org/ - - - hui poh goh https://orcid.org/ - - - x key: cord- -ew lwmsn authors: haddow, george d.; haddow, kim s. title: communicating during a public health crisis date: - - journal: disaster communications in a changing media world doi: . /b - - - - . - sha: doc_id: cord_uid: ew lwmsn “communicating during a public health crisis,” examines how communicating to the public and media during a public health or safety emergency is different. in a serious crisis, all affected people take in information differently, process information differently and act on information differently. this chapter incorporates the centers for disease control and prevention’s (cdc) best advice for communicating during a public health crisis, including infectious disease outbreaks, bioterrorism, chemical emergencies, natural disasters, nuclear accidents and radiation releases and explosions. this chapter also explores the growing role of social media that is now being used for a variety of traditional and new purposes from distress calls to disease surveillance. social media is now a part of the public health communications toolbox. from the cdc down to local departments of health, public health, and safety officials are using social media to push out vital and useful information to the public and to monitor and respond to public comments. but social media is also being used for a broader range of public health purposes-from collecting data to track the spread of diseases to sending calls for help-and the public health system is still figuring out how to adapt. "the use of social media has proven a valuable asset for adaptation and improvisation related to the public health and medical consequences of disasters. these tools are especially valuable for saving lives during a disaster's impact phase and especially during its immediate aftermath, when traditional disaster management capabilities are not available…. the need remains for fusion of social media into existing institutional programs for crisis informatics and disaster-risk management" (keim and noji, ) . the center for disease control and prevention is actively using social media, but social media use by public health agencies is still considered to be in the "early adoption stage" (thackeray et al., ) . even though the majority of state health departments ( %) report using at least one social media application, they are "using social media as a channel to distribute information rather than capitalizing on the interactivity available to create conversations and engage with the audience" (thackeray et al., ) . according to a report on the use of social media by state health departments, . percent of the state health departments reported they had a twitter account, percent a facebook account, and percent a youtube channel; but, "on average, state health departments made one post per day on social media sites, and this was primarily to distribute information; there was very little interaction with audiences. shds have few followers or friends on their social media sites. the most common topics for posts and tweets related to staying healthy and diseases and conditions" (thackeray et al., ) . the report recommends, "because social media use is becoming so pervasive, it seems prudent for state health departments to strategically consider how to use it to their advantage. to maximize social media's potential, public health agencies should communicating during a public health crisis chapter eleven develop a plan for incorporating it within their overall communication strategy. the agency must identify what audience they are trying to reach, how that audience uses social media, what goals and objectives are most appropriate, and which social media applications fit best with the identified goals and objectives" (thackeray et al., ) . there are examples of health departments and associations using social media to augment their communications efforts: • in shelby county, tennessee, the health department is using twitter to increase its media coverage. they tweet out their press releases which are retweeted by reporters-expanding the department's public reach. • in philadelphia, the department of hiv planning uses twitter to increase participation in their community workshops. they tweet out the meeting's content to people in the large nine-county area they serve and use twitter to "extend the conversation beyond the room." • the american public health association (@publichealth) took advantage of the super bowl to promote related health messages using the #superbowl hashtag. they tweeted about healthy snacks, drinking and driving, and flu vaccination. when the half-hour blackout hit, they took advantage of the unexpected opportunity with the tweet in figure . , which was widely retweeted. at the annual meeting for the national association of county and city heath officials (naccho), additional examples of health departments' use of social media were highlighted (new public health, ): • the kansas city health department uses twitter and facebook to push information on extreme heat safety during the summertime. the messages and reports of suspected or confirmed heat-related deaths resulted in coverage of health department activities and partnerships on national news channels including the weather channel and cnn. the boston health commission used social media to promote its youth media campaign on sugary beverages. the campaign received close to , views, and close to , clicks on their facebook ads. • in contra costa, california, a recent campaign included a podcast by the public health director that was promoted on twitter and facebook. parts of the podcast were picked up by local radio which allowed the public health department to most accurately get their message across. the cdc, which has been a pioneer in the integration of social media tools into public health communications, including their multichannel "zombie"-themed emergency preparedness public education campaign (cdc, ) , has developed and is distributing a social media toolkit for health communicators. the cdc's "socialmediaworks" toolkit was designed to help "health communicators integrate social media strategies and technologies into their communication plans." the kit features tools to develop a better social media strategy, learn how social media tools work, plan, implement, and manage all in one place including "calendar and dashboard features that allow you to schedule and manage your social media initiative," and hosts a community forum to enable health professionals to "engage with colleagues on social media strategy, share lessons learned, and learn what works" (cdc, ). in a new england journal of medicine article, "integrating social media into emergency-preparedness efforts," the reason given by the three authors to the pervasiveness of social media is "it makes sense to explicitly consider the best way of leveraging these communication channels before, during, and after disasters…. engaging with and using emerging social media may well place the emergency-management community, including medical and public health professionals, in a better position to respond to disasters" (merchant et al., ) . specifically, they suggest: • actively using networking sites such as facebook to help individuals, communities, and agencies share emergency plans and establish emergency networks. web-based "buddy" systems, for example, might have allowed more at-risk people to receive medical attention and social services during the chicago heat wave, when hundreds of people died of heat-related illness. • linking the public with day-to-day, real-time information about how their community's health care system is functioning. for example, emergency room and clinic waiting times are already available in some areas of the country through mobile-phone applications, billboard really simple syndication (rss) feeds, or hospital tweets. monitoring this important information through the same social channels during an actual disaster may help responders verify whether facilities are overloaded and determine which ones can offer needed medical care. • using location-based service applications (such as foursquare and loopt) and global positioning system (gps) software to allow people to "check in" to a specific location and share information about their immediate surroundings. with an additional click, perhaps off-duty nurses or paramedics who check in at a venue could also broadcast their professional background and willingness to help in the event of a nearby emergency. • increasing the use of social media during recovery. the extensive reach of social networks allows people who are recovering from disasters to rapidly connect with needed resources. tweets and photographs linked to timelines and interactive maps can tell a cohesive story about a recovering community's capabilities and vulnerabilities in real-time. "organizations such as ushahidi have helped with recovery in haiti by matching volunteer health care providers with distressed areas. social media have been used in new ways to connect responders and people directly affected by such disasters as the deepwater horizon oil spill, flash floods in australia, and the earthquake in new zealand with medical and mental health services" (merchant et al., ) . in late , there was a strange increase in emergency room visits in guangdong province in china for acute respiratory illness and a number of local news and internet reports about a respiratory disease affecting healthcare workers. several long weeks later, the government announced the cause was severe acute respiratory syndrome, or sars. according to dr. john brownstein, one of the developers of healthmap, an online platform that mines informal sources for disease outbreak monitoring, "if this data had been harvested properly and promptly, this early epidemic intelligence collected online could have helped contain what became a global pandemic" (brownstein, ) . "we are now in an era where epidemic intelligence flows not only through government hierarchies but also through informal channels, ranging from press reports to blogs to chat rooms to analyses of web searches. collectively, these sources provide a view of global health that is fundamentally different from that yielded by disease reporting in traditional public health infrastructures," dr. brownstein explained. "they also provide a process that dramatically reduces the time required to recognize outbreaks" (brownstein, ) . more recently, the explosion of online news and social media has brought a new era of disease surveillance. today, the websites healthmap.org and outbreaks near me deliver real-time intelligence on a broad range of emerging infectious diseases for a diverse audience, which includes local health departments, governments, clinicians, and international travelers. healthmap.org states they "bring together disparate data sources, including online news aggregators, eyewitness reports, expert-curated discussions and validated official reports, to achieve a unified and comprehensive view of the current global state of infectious diseases and their effect on human and animal health. through an automated process that updates / / , the system monitors, organizes, integrates, filters, visualizes and disseminates online information about emerging diseases in nine languages, early detection of global public health threats" (healthmap.org, ) . healthmap is part of a growing landscape of government and nongovernment organizations mining internet and social data to determine the spread of viruses and the rate of infection. some organizations are also asking the public to self-report how they are feeling, according to kim stephens, the lead blogger of idisaster . , who outlines several tools being used to aggregate data to fight the flu and other diseases. google flu trends is a site that provides geographically based information about the spread of the influenza virus. their data is aggregated from the search terms people are using versus self-reporting. in fact, the graph of the tracked searches (see below) related to the flu compared to the actual reported cases of the virus is so close that they almost overlap. google explains how this works: we have found a close relationship between how many people search for flu-related topics and how many people actually have flu symptoms. of course, not every person who searches for "flu" is actually sick, but a pattern emerges when all the flu-related search queries are added together. we compared our query counts with traditional flu surveillance systems and found that many search queries tend to be popular exactly when flu season is happening. by counting how often we see these search queries, we can estimate how much flu is circulating in different countries and regions around the world. google's results have been published in the journal nature (stephens, ) . mappyhealth is another tool that tracks keywords related to health but instead of using data from searches in google, this system uses the twitter data stream. their stated reason for the site: "it is hypothesized that social data could be a predictor to outbreaks of disease. we track disease terms and associated qualifiers to present these social trends." although this blog post is focused on influenza, the mappyhealth site tracks different categories of illness (stephens, ) . flunearyou is a tool that allows the public to participate in tracking the spread of flu by filling out a survey each week. the survey is quite simple and asks the respondent if they have had any symptoms during the past week and whether or not they have had the flu shot either this year or last year. respondents can include family members and the questions are asked about each person individually. this user-contributed data is then aggregated and displayed on a map with pins that are either green for no symptoms, yellow for some, and red for "at least one person with influenza-like" symptoms. the pins are clickable and display the number of users in that zipcode that have reported their condition, but no personal information whatsoever. the number of participants in the state is displayed ( in massachusetts) as well as locations and addresses where people can get vaccinated. links to local public health agencies are also provided. people can also sign up to receive location-based disease alerts via email. social sharing of the site and its content is encouraged by the addition of prominently placed social media buttons (stephens, ) . consumer-oriented applications also are being developed such as sickweather, which tracks social media posts that reference illnesses and displays trends by location. sickweather also shows illness patterns over time and allows members to report their illness directly and share information with friends through social networks (newcomer, ) . the department of homeland security (dhs) is also mining social media for biosurveillance. dhs is testing whether scanning social media sites to collect and analyze health-related data could help identify infectious disease outbreaks, bioterrorism or other public health and national security risks. the -year biosurveillance pilot involves automatically scanning social media sites, such as facebook and twitter, to collect and analyze health-related data in real-time (sternstein, ) . the social media data analytics technology will "watch for trends," such as whether new or unusual clusters of symptoms in various geographic regions are being reported on social networking sites. the project is the latest in a series of dhs data analysis efforts for biosurveillance. for example, dhs is already analyzing data that is collected by the cdc from public health departments nationwide. also, it is collecting and analyzing air samples in several cities for signs of bioterrorist chemicals, such as anthrax (sternstein, ) . news organizations are providing the public with information about the effects of the influenza virus and some are also using social media to increase public awareness. at the height of the flu season a #fluchat was sponsored by @usatodayhealth. "health based twitter chats offer the public the opportunity to post questions that are addressed by healthcare professionals or researchers. the cdc, for instance, has conducted many chats on a wide variety of topics. watching the questions that are posted in these chats offers local public health organizations an opportunity to "hear" the concerns of the public. knowing this information can help with message formulation and coordination" (stephens, ) . here are a few questions posted to the #fluchat: @usatodayhealth how long after the flu shot are you actually prevented from getting the flu? #fluchat-taylor yarbrough (@sellorelse) january , @usatodayhealth what % of americans have gotten the flu each of the last years?-bob (@sgt ) january , (stephens, ) finally, a trend that will once again change the way public health and safety agencies and organizations operate during disasters-the increased use of facebook and twitter to call for help or rescue. more and more people are turning to social media as their first choice of communications during a crisis. public polling by the red cross in and documents the public's large and growing expectation that disaster officials monitor social media sites and respond quickly to distress calls on facebook, twitter, and other platforms. according to red cross surveys: • percent expect emergency responders to monitor social sites-and to respond promptly for calls for help. • percent would try an online channel to get help if unable to reach emergency medical services (ems). • at least a third of the public expects help to arrive in less than an hour if they posted a request for help on a social media website-and more than three out of four ( %) expect help within hours-up from percent in (american red cross, ). clearly meeting this challenge and responding to these expectations must be a priority for the public health and safety community. communicating to the public and media during a public health or safety emergency is different in several aspects than other disaster communications. in a serious crisis, all affected people take in information differently, process information differently, and act on information differently. in recognition of those differences, the cdc has published its own, highly recommended "crises and emergency risk communications manual." highlights from the edition of the cdc manual follow below. the purpose of an official response to a public health crisis is to efficiently and effectively reduce and prevent illness, injury, and death, and return individuals and communities to normal as quickly as possible. specific hazards under cdc emergency preparedness and response include: • infectious disease outbreaks-the spread of viruses, bacteria, or other microorganisms that causes illness or death. this includes cholera, e. coli infection, pandemic flu, and other infections. • bioterrorism-the deliberate release of viruses, bacteria, or other germs (agents) used to cause illness or death, including anthrax and the plague. • chemical emergencies-the intentional or unintentional release of a chemical that could harm people's health including chlorine, mercury, nerve agents, ricin, or an oil spill. the cdc also has a role in responding to natural disasters, nuclear accidents, and radiation releases and explosions. so what is the public's response to one of these disasters? • fear, anxiety, confusion, and dread-these are emotions that need acknowledging. • hopelessness and helplessness-part of the job of a crises communicator is to help the community manage its fears and set them on a course. action helps reduce anxiety and restores a sense of control, even if it is symbolic, put up the flag, or preparatory-donate blood, or just as simple, check on an elderly neighbor. • uncertainty-people dislike uncertainty. the not-knowing can seem worse than a bad result. people can manage uncertainty if you share with them the process you are using to get answers. "i can't tell you what's causing so many people in our town to get so sick. but i can tell you what we're doing to find out…." the situation may obviously be uncertain and acting otherwise creates mistrust. • not panic-panic during a crisis is rare. contrary to what we see portrayed in the movies, we seldom act irrationally when faced with a crisis-and we seldom panic. people nearly always behave in a rational way during a crisis. in the face of the / attacks, people in lower manhattan became simultaneously resourceful and responsive. when told what to do by those in authority, people followed instructions. the panic myth is one of the most pervasive misconceptions about crises. many government leaders are concerned about causing public panic. when facing a crisis, they may mistakenly withhold information in an effort to prevent panic and protect the public-at the very time they should be sharing their concerns. conditions that are likely to create heightened anxiety and severe emotional distress are silence or conflicting messages from authorities. people are likely to be very upset when they feel: • they cannot trust what those in authority are telling them. • they have been misled or left without guidance during times of severe threat. • if authorities start hedging or hiding the bad news, they will increase the risk of creating a confused, angry, and an uncooperative public. the faster you give bad news, the better. holding back implies mistrust, guilt, or arrogance. in general, the public wants access to as much information as possible. too little information enhances the psychological stress. if information is incomplete or not present at all during a crisis, this will increase anxiety and increase a sense of powerlessness. it will also lower trust in government agencies. the cdc has found that people may receive, interpret, and act on information differently during an emergency than during a normal period. four factors that change how we process information during a crisis: . we simplify messages-under intense stress and possible information overload, we tend to miss the nuances or importance of health and safety messages by: • not fully hearing information, because of our inability to juggle multiple facts during a crisis. • not remembering as much of the information as we should. • confusing action messages, such as remembering which highway is blocked for safety to cope, many of us may not attempt a logical and reasoned approach to decision making. instead, we may rely on habits and long-held practices. we might also follow bad examples set by others, and engage in irrational behaviors like unfairly blaming leaders or institutions. asking people to do something that seems counterintuitive. examples include the following: • getting out of a safe car and lying in a ditch instead of outrunning a tornado. • evacuating even when the weather looks calm. changing our beliefs during a crisis or emergency may be difficult. beliefs are very strongly held and are not easily altered. see, and tend to believe what we've experienced. during crises, we want messages confirmed before taking action. you may find that you or other individuals are likely to do the following: • change television channels to see if the same warning is being repeated elsewhere. • try to call friends and family to see if others have heard the same messages. • check in on their social media networks to see what their friends and family are doing. • turn to a known and credible local leader for advice. • in cases where evacuation is recommended, we tend to watch to see if our neighbors are evacuating before we make our decision. this confirmation first-before we take action-is very common in a crisis. . we believe the first message-during a crisis, the speed of a response can be an important factor in reducing harm. in the absence of information, we begin to speculate and fill in the blanks. this often results in rumors. the first message to reach us may be the accepted message, even though more accurate information may follow. when new, perhaps more complete information becomes available, we compare it to the first messages we heard. therefore, messages should be simple, credible, and consistent. speed is also very important when communicating in an emergency. an effective message must: • be repeated. • come from multiple credible sources. • be specific to the emergency being experienced. • offer a positive course of action that can be executed. people should also have access to more information, through other channels, such as through websites, and old and new media. good communication can reduce stress, harmful human behavior, and prevent negative public health response outcomes. trained communicators will do the following: • reduce high levels of uncertainty. • use an effective crisis-communication plan. • be the first source for information. • express empathy and show concern. • exhibit competence and expertise. • coordinate with other response officials. • commit and remain dedicated to the response and recovery after the immediate crisis has passed. audiences receive, interpret, and evaluate messages before they take action. expect your audience to immediately judge the content of your message for speed, factual content, and trust and credibility: was the message timely without sacrificing accuracy? one of the primary dilemmas of effective crisis and emergency risk communication is to be speedy in responding but maintain accuracy even when the situation is uncertain. being first to communicate establishes your organization as the primary source of information. the public may judge how prepared your organization was for the emergency based on how fast you responded. speedy responses suggest that there is a system in place and that appropriate actions are being taken. remember that if agencies are not communicating, audiences will turn to other, less credible sources. first impressions are lasting impressions, and it's important to be accurate. responding quickly with the wrong information or poorly developed messages damages credibility. this does not necessarily mean having all the answers; it means having an early presence so the public knows that agencies are engaged and that there is a system in place to respond. research shows there are some basic elements to establishing trust and credibility through communications, and you will notice they repeat the important elements in executing a successful crisis communication plan: empathy and caring-this needs to be expressed in the first seconds. according to research, being perceived as empathetic and caring increases the chances your message will be received and acted on. acknowledge fear, pain, suffering, and uncertainty. competence and expertise-the public will be listening for factually correct information, and some people will expect to hear specific recommendations for action. therefore, you should do the following: • get the facts right. • repeat the facts often, using simple nontechnical terms. • avoid providing sketchy details in the early part of the response. • ensure that all credible sources share the same facts. speak with one voice. inconsistent messages will increase anxiety, quickly undermining expert advice and credibility. honesty and openness-this does not mean releasing information prematurely. it means being transparent-admitting when you do not have all the information, telling the public you do not, and why. the perception of risk is not about numbers alone and communicators should consider the following rules for raising the public's comfort level during a crisis. these are adapted from the environmental protection agency's seven cardinal rules of risk communication. . accept and involve the public as a legitimate partner-two basic tenets of risk communication in a democracy are generally understood and accepted. first, people and communities have a right to participate in decisions that affect their lives, their property, and the things they value. second, the goal should be to produce an informed public that is involved, interested, reasonable, thoughtful, solution-oriented, and collaborative. you should not try to diffuse public concerns and avoid action. guidelines: • show respect for the public by involving the community early, before important decisions are made. • clarify that decisions about risks will be based not only on the magnitude of the risk but on factors of concern to the public. . listen to the audience-people are often more concerned about issues such as trust, credibility, control, benefits, competence, voluntariness, fairness, empathy, caring, courtesy, and compassion. they are not as interested in mortality statistics, and the details of a quantitative risk assessment. if your audience feels or perceives that they are not being heard, they cannot be expected to listen. effective risk communication is a two-way activity. guidelines: • do not make assumptions about what people know, think, or want done about risks. • listen. monitor social media and comments on your website. make an active effort to find out what people are thinking and feeling. • involve all parties who have an interest or a stake in the issue. • identify with your audience and try to put yourself in their place. • recognize people's emotions. • let people know that you understand their concerns and are addressing them. understand that audiences often have hidden agendas, symbolic meanings, and broader social, cultural, economic, or political considerations that complicate the task. accepted, the messenger must be perceived as trustworthy and credible. so the first goal must be to establish trust and credibility. short-term judgments of trust and credibility are based largely on verbal and nonverbal communications. longterm judgments are based largely on actions and performance. once made, trust and credibility judgments are resistant to change. in communicating risk information, these are your most precious assets. once lost, they are difficult to regain. guidelines: • express willingness to follow up with answers if the question cannot be answered at the time you are speaking. • make corrections if errors are made. • disclose risk information as soon as possible, emphasizing appropriate reservations about reliability. • do not minimize or exaggerate the level of risk. • lean toward sharing more information, not less, to prevent people from thinking something significant is being hidden. • discuss data uncertainties, strengths, and weaknesses, including the ones identified by other credible sources. • identify worst-case estimates and cite ranges of risk estimates when appropriate. . coordinate and collaborate with other credible sources-allies can be effective in helping communicate risk information. few things make risk communication more difficult than public conflicts with other credible sources. guidelines: • coordinate all communications among and within organizations. • devote effort and resources to the slow, hard work of building bridges, partnerships, and alliances with other organizations. • use credible and authoritative intermediaries. • consult with others to determine who is best able to answer questions about risk. • try to release communications jointly with other trustworthy sources, such as: -university scientists. -physicians. -local or national opinion leaders. -citizen advisory groups. -local officials. . meet the needs of the media-the media are primary transmitters of risk information. they play a critical role in setting agendas and in determining outcomes. the media generally have an agenda that emphasizes the more sensational aspects of a crisis. they may be interested in political implications of a risk. the media tend to simplify stories rather than reflect the complexity. guidelines: • remain open with, and accessible to, reporters. • respect their need to "feed the beast"-to provide news for an audience that is eager for information / . provide information tailored to the needs of each type of media, such as sound bites, graphics, and other visual aids for television. • agree with the reporter in advance about specific topics and stick to those during the interview. • prepare a limited number of positive key messages in advance and repeat the messages several times during the interview. • provide background material on complex risk issues. • do not speculate. the cdc has produced a series of manuals, toolkits, and trainings that are helping integrate social media into the disaster communications planning and operations of public health officials at every level and are helping speed up the adaption of these tools for saving lives. • keep interviews short and follow up on stories with praise or criticism, as warranted • establish long-term trust relationships with specific editors and reporters speak clearly and with compassion-technical language and jargon are barriers to successful communication with the public. in low-trust, high-concern situations, empathy and caring carry more weight than numbers and technical facts. guidelines: • use plain language • remain sensitive to local norms, such as speech and dress strive for brevity, but respect people's needs and offer to provide more information if needed • use graphics and other pictorial material to clarify messages • personalize risk data by using anecdotes that make technical data come alive. • acknowledge and respond to emotions that people express • promise only what can be delivered • understand and convey that any illness, injury, or death is a tragedy • avoid distant, abstract, unfeeling language about deaths, injuries, and illnesses • do not discuss money-the magnitude of the problem should be in the context of the health and safety of the people-loss of property is secondary give people things to do-in an emergency, simple tasks will: • give people a sense of control • keep people motivated to stay tuned to what is happening • prepare people to take action if and when they need to do so do no harm-the odds of a negative public response increases when poor communication practices are added to a crisis situation • public power struggles, conflicts, and confusion • perception that certain groups are getting preferential treatment more americans using mobile apps in emergencies using social media for disease surveillance. cnn global public square emergent use of social media: a new age of opportunity for disaster resilience integrating social media into emergency-preparedness efforts using social media to extend the reach of local public health departments idisaster . : social media and emergency management. fighting influenza with data nextgov. dhs tries monitoring social media for signs of biological attack adoption and use of social media among public health departments key: cord- - r s authors: farhoudian, ali; baldacchino, alexander; clark, nicolas; gerra, gilberto; ekhtiari, hamed; dom, geert; mokri, azarakhsh; sadeghi, mandana; nematollahi, pardis; demasi, maryanne; schütz, christian g.; hash-emian, seyed mohammadreza; tabarsi, payam; galea-singer, susanna; carrà, giuseppe; clausen, thomas; kouimtsidis, christos; tolomeo, serenella; radfar, seyed ramin; razaghi, emran mohammad title: covid- and substance use disorders: recommendations to a comprehensive healthcare response. an international society of addiction medicine practice and policy interest group position paper date: - - journal: basic clin neurosci doi: . /bcn. .covid . sha: doc_id: cord_uid: r s coronavirus disease (covid- ) is escalating all over the world and has higher morbidities and mortalities in certain vulnerable populations. people who use drugs (pwud) are a marginalized and stigmatized group with weaker immunity responses, vulnerability to stress, poor health conditions, high-risk behaviors, and lower access to health care services. these conditions put them at a higher risk of covid- infection and its complications. in this paper, an international group of experts on addiction medicine, infectious diseases, and disaster psychiatry explore the possible raised concerns in this issue and provide recommendations to manage the comorbidity of covid- and substance use disorder (sud). oronavirus disease (covid- ) is a new member of the coronavirus family that infect humans . it first emerged in the wuhan region of china in november (lai shih, ko, tang, & hsueh, ) . by march , the world health organization (who) assessed the global situation of covid- as a pandemic. patients with cardiovascular diseases, chronic respiratory diseases, people aged or older, and males have a higher risk of mortality than the rest of the population huang et al., ; wang et al., ) . frequently reported clinical symptoms at the onset of the disease include pyrexia ( %- %), cough ( %- %), myalgia or fatigue ( %- %), and shortness of breath ( %) huang et al., ; wang et al., ) . sore throat and, less commonly, sputum production, headache, hemoptysis, and diarrhea have also been reported (chan et al., ) . in more severe cases, covid- can cause pneumonia, severe and acute respiratory syndrome, and sometimes ( %- % of all infected cases) death (world health organization, b) . currently, the medications used for severe cases of covid- include chloroquine phosphate (gao, tian, & yang, ) , hydroxychloroquine sulfate (javadi et al., ) , lopinavir/ritonavir (li & de clercq, ; lim et al., ) , oseltamivir (li & de clercq, ; vetter, eckerle, & kaiser, ) , and ribavirin (li & de clercq, ) . but none have been approved by regulatory authorities for use against covid- . the most common strategies, as advised by who, include preventative measures such as quarantine and limitations of movement in infected areas (hellewell et al., ; wu, leung, & leung, ) , interruption of human-to-human transmission, early identification and isolation, providing appropriate care for patients, identifying and reducing transmission from the animal source, and minimizing the social and economic impact through the new coronavirus created a complex situation for all sections of the communities around the world. health care providers are in the frontline of intervening to stop the spread of covid- . meantime people who use drugs (pwud) are at increased risk during this pandemic since they are a stigmatized and marginalized populations. health service providers who are providing different needs for pwud in treatment and/or harm reduction settings should always keep themselves safe with using standard ppe based on the who recommendations. additionally pwuds live in crowded locations and so screening and early identification of covid- patients are important to break the cycle of transmission. it is recommended that protocols for opioid substitution therapy modify with complete adherence to patients' safety regarding both opioid drug risks and covid- infections. it is important to have in mind that different stages of ost needs different approaches. pwuds are more vulnerable to stress and other mental health problems. this makes psychological interventions such as cognitive-behavioral therapy and other modalities very important to have for pwuds during these difficult and challenging times to assist and sustain treatment. medical conditions such as respiratory illness, renal insufficiency, chronic pain and cardiovascular disorders are also important medical conditions that should be addressed appropriately among pwuds with covid- . health service providers in both fields of addiction treatment and covid- treatment and prevention systems should be aware regarding special situations arising in the overlap of drug use and covid- illness. march, april , vol , num [covid- ] farhoudian, a., et al. ( ) . covid- and substance use disorders. bcn, ( ), - . multispectral partnerships (world health organization, a). bai and colleagues mentioned some covid- transmission from asymptomatic patients as a challenge for preventive activities (bai et al., ) . in most countries, people who use drugs (pwud) are stigmatized and marginalized population with lower access to healthcare. they suffer from poorer health, weaker immune function, chronic infections, various issues with respiratory, cardiovascular, and metabolic systems, as well as a range of psychiatric comorbidities (ahern, stuber, & galea, ; stuber, galea, ahern, blaney, & fuller, ) . pwud are a marginalized group who experience high rates of morbidities, three to five times higher compared to the general population (o'connell, ) . cheung et al. estimated that the risk of death among young pwud homeless women in toronto is to times higher than their housed counterparts (bohnert & ilgen, ; fernandez-quintana et al., ) . substance use imposes different health problems, which may complicate superimposed infection with co-vid- . for instance, chronic high alcohol consumption significantly increases the risk of acute respiratory distress syndrome (mccarthy et al., ) . during the h n epidemic, a history of opium inhalation had been identified as a risk factor for admission to an intensive care unit (icu) with confirmed h n (tabarsi et al., ) . additionally, it is essential to understand how pwud differently perceive danger and risk-taking behaviors during an epidemic, making them more risk averse (manfredi & d'onofrio, ; rhodes, ) . pwud have a higher rate of smoking and different studies estimated the current smoking rate of more than % among them (duan et al., ; sutherland et al., ; weinberger, gbedemah, & goodwin, ) . several studies found smoking a significant risk factor for middle east respiratory syndrome (mers) transdmission (alraddadi et al., ; nam, park, ki, yeon, kim, & kim, ; sherbini iskandrani, kharaba, khalid, abduljawad, & hamdan, ) . a literature review did not reveal even one article focusing on substance use disorder (sud) and covid- . therefore, a group of international experts on addiction medicine, infectious diseases, and disaster management teamed up to explore the comorbidity of covid- infection with substance use disorder and identify the necessary recommendations for health service providers and policymakers in this situation. although the majority of covid- infections are mild, the number of severe cases in a pandemic has the potential to overwhelm any healthcare system. consequently, health authorities may be required to repurpose health services and facilities away from pwud. when such an incident occurs, a business continuity protocol will cover several contingency measures so that organizations supporting pwud will continue to provide their essential services. a response to both covid- and drug use involves government, different sectors of the community and health authorities (who director-general's opening remarks at the media briefing on covid- on march , ) to implement evidence-based prevention programs as well as engaging different stakeholders for policy coordination (volkow, poznyak, saxena, gerra, & unodc-who informal international scientific network, ) . generally, drug use prohibition and criminalization approaches result in higher stigmatization and discrimination against pwud (boyd & macpherson, vancouver area network of drug users, ; santos da silveira, andrade de tostes, wan, ronzani, & corrigan, ) . this approach puts pwud at a higher risk of viral transmission. governments, health authorities, and other relevant stakeholders should identify the provision of services for pwud as essential services to support a comprehensive and proactive response to the challenges that covid places on this population, especially when they are under treatment (ekhtiari et al., ). pwud have poor access to health services due to stigma and discrimination (ahern, stuber, & galea, ; salamat, hegarty, & patton, ) . they are among the pervasive hard-to-reach populations. for example, studies show that drug use is one of the significant barriers to taking the influenza vaccine (bryant et al., ; kong, chu, & giles, ) . many homeless pwud communities live in crowded groups in shelters and or shooting galleries with no or minimal air conditioning facilities. additionally, poor hygiene, risky behaviors such as sharing drug-using paraphernalia and intoxication put pwud at higher risk of covid- infection. one of the other risk factors for pwud and people who inject drugs (pwid) is their weaker immune system due to a range of factors. these factors include long-term/high-dose administration of opioid drugs (liang, liu, chen, ji, & li, ; sacerdote, franchi, gerra, leccese, panerai, & somaini, ) , malnutrition (haber, demirkol, lange, & murnion, ; vila et al., ) , homelessness (haber et al., ) , and longterm alcohol and methamphetamine use (nelson, zhang, bagby, happel, & raasch, ; roy et al., ) . despite lacking evidence for introducing hiv as a risk factor for covid- (british hiv association, ), there are some concerns regarding the access to treatment services for people living with hiv/aids (plwha) and their adherence to antiretroviral therapy (dadkha, mohammadi, & mozafari, ) . this situation could finally increase the rate of mortality among plwha. on the other hand, respiratory infections among pwud are common and, in many cases, do not present with recognized symptoms of these diseases (dimassi & rushton, ; bradley drummond et al., ; gordon & lowy, ) . tuberculosis is another respiratory infection that is more common among pwud (perlman, salomon, perkins, yancovitz, paone, & jarlais, ) even in high-income countries heuvelings et al., ) . care providers are at the front line of any outbreak response. they are not only at the risk of infection but are also prone to burnout and psychological distress. in a study conducted on frontline staff involved in the severe acute respiratory syndrome (sars) epidemic, it was found that they had high levels of burnout, psychological distress, and posttraumatic stress (maunder et al., ) . this situation is compounded with evidence that counselors and therapists for pwud are well-known as having a higher rate of burnout (vilardaga et al., ) during usual practice. staff working in harm reduction settings, where most of the health service providers are peer groups, should be adequately supported. this support should prevent cross-viral exposure, psychological distress (hashemian et al., ; lancee, maunder, & goldbloom, ) , psychiatric disorders (tang, pan, yuan, & zha, ; , discrimination (gilchrist et al., ) , and physical and psychological violence (world health organization, b). concerns regarding infection and the above mentioned stressful events may affect their effectiveness in an outbreak (abolfotouh, alqarni, al-ghamdi, salam, al-assiri, & balkh, ) . all staff should have access to personal protection equipment (ppe). they should perform hand hygiene frequently, use alcohol-based hand rub/gels if their hands are not visibly soiled or with soap and water when they are visibly soiled. they must keep at least one meter distance from affected individuals, wear a medical mask when in the same room with an affected individual, and dispose of the material immediately after use. they should clean their hands immediately after contact with respiratory secretions, cover the nose and mouth with a flexed elbow or disposable tissue when coughing and sneezing, and refrain from touching eyes, nose, or mouth with potentially contaminated hands (world health organization, b). also, they must avoid close contact with anyone that has fever or cough (world health organization, b) and finally improve airflow in living space by opening windows as much as possible (world health organization, b). self-isolation of individual staff is paramount if there are signs of an infection (heymann & shindo, ; world health organization, a) . pwud staff still need to retain their crucial role at a distance either through digital technology or phone and continue their pwud management and treatment plan, such as the provision of daily ost medication (tschakovsky, ). there is no convincing evidence that the paraphernalia and devices for drug use are the primary sources of virus transmissions in the latest epidemics of coronaviruses (alagaili, briese, amor, mohammed, & lipkin, ) . however, as the main source of viral transmission has been defined to occur through the droplets, it makes sense to advise pwud populations to avoid sharing cigarettes, pipes , water pipes and hookahs, and so on (knishkowy & amitai, ; munckhof, konstantinos, wamsley, mortlock, & gilpi, ) . one should continue providing clean needle and syringes and 'take-home' naloxone (thn) when appropriate. infected patients are most virulent during the prodromal period. in the case of being mobile and carrying on usual activities, they play an essential part in spreading the infection to the other parts of the community (heymann & shindo, ). in such conditions, it is imperative to have an effective mechanism for the active and rapid detection of signs and symptoms and patient's isolation (hellewell et al., ; shamaei et al., ) . during the h n pandemic in , one of the risk factors for death or admission at intensive care units was a delay in diagnosis (tabarsi et al., ) . early detection in pwud can be difficult as covid- symptoms could be confused with a withdrawal syndrome (dimassi & rushton, ; bradley drummond et al., ; gordon & lowy, ) . it is highly recommended that a mechanism be implemented for the frequent screen-ing of covid- in pwud within harm reduction and treatment settings (salamat, hegarty, & patton, ; van olphen, eliason, freudenberg, & barnes, ). any pandemic affects illicit drug distribution networks (rahimi movaghar, farhoudian, rad goodarzi, sharifi, yunesian, & mohammadi, ) . sometimes this situation persuades pwud to seek treatment services for help, but usually, they switch to a more hazardous consumption. the iranian covid pandemic generated the highest incidence of mortality secondary to methanol toxicity (at least dead from drinking toxic alcohol in iran after coronavirus cure rumor, ; tainted alcohol claims more lives than coronavirus in khuzestan province, iran, ). however, opioid substitution therapy (ost) provision of controlled medication has become the main focus of the continuity plans around pwud to make sure that such provision is not interrupted during the covid- lockdown strategies (being imposed by several governments). any close personal contact may be harmful and risky for covid- transmission. methadone syrup and buprenorphine tablets or film are often provided to pwud after bringing out their blister packs. despite no evidence, this action might increase the chance of viral transmission by exposing both staff and pwud. it is recommended that dispensing clinics be trained to handle the process of tablet delivery with minimum hand contact. take-home doses of medications can be provided for more extended periods in situations of quarantine, selfisolation, or lockdown and health service disruptions. the maximum time for take-home doses of drugs is recommended when the dose and social situation are stable. treatment seeking individuals should be adequately informed about the changes in the practice, and they should receive appropriate support in case of uncertainty and concerns. however, decisions should be taken on a case by case basis. in summary, individuals under buprenorphine maintenance treatment (bmt) can receive accelerated take-home doses after two weeks of initiation. in particular, the people can receive this protocol who are at least on mg methadone or mg daily buprenorphine and have no signs of withdrawal symptoms, do not experience craving (mokri, ekhtiari, edalati, & ganjgahi, ) , are abstinent based on self-reporting, and provide negative toxicological tests. this condition should be reviewed every days if the individuals provided with take-home doses are not showing the stability mentioned above. buprenorphine take-home doses are probably safer than methadone take-home doses. if the person is in isolation and unable to pick up their medication personally, it can be delivered to their homes, or they can authorize someone else to collect the medication. opioid substitution therapy (ost) is among a category of treatment modalities that is normally considered to need regular and frequent supervision of patients, especially early in treatment. it is recommended that a more flexible ost program needs to be taken into account during the covid pandemic . given the safety profile of buprenorphine, it would seem to be the preferred substitution treatment for individuals who want to initiate treatments. it is faster and safer (maremmani & gerra, ) to reach an effective maintenance dose of buprenorphine compared to methadone, in fact it can be done on the first day of treatment. some of the medications under consideration for the treatment of covid- can significantly inhibit and/or stimulate methadone metabolism, puting patients at the risk of withdrawal or toxicity (lüthi, huttner, speck, & muelle, ; winton & twilla, ) . methadone specifically in high doses may prolong qt interval and cause fatal arrhythmias (krantz, lewkowiez, hays, woodroffe, robertson, & mehle, ) . possible cardiomyopathy in infected patients may increase the chance of torsade's de pointes arrhythmia (lüthi et al., ) and, particularly if combined with chloroquine which also prolongs the qt interval. withdrawal symptoms from buprenorphine are milder than that of methadone in case of interruption to the supply of medication, at least in the short term. where available, the long acting (monthly) subcutaneous injections are an alternative to providing take home doses. even transdermal buprenorphine should be considered where no other alternatives exist. multiple patches can be given simultaneously if necessary to achieve a therapeutic dose for opioid dependence treatment. additionally, benzodiazepine prescription for myalgia or stressful circumstances due to covid- may also increase the risk of toxicity during methadone mainte-nance treatment (mmt). during the pandemic period, it is more likely that individuals with drug use disorders or those who are in treatment seek out benzodiazepines or other tranquillizers (dorn, yzermans, & van der zee, ; fassaert et al., ) . benzodiazepines misuse may mask signs and symptoms of covid- infection and could escalate respiratory distress. patients are at a higher risk of methadone overdose in the initial stabilization period of methadone prescription (cornish, macleod, strang, vickerman, & hickman, ; degenhardt, randall, hall, law, butler, & burns, ) . for mmt patients, the authors do not recommend relaxing the methadone dose protocol at this phase of treatment however they do suggest avoiding unnecessary visits and rigor, on a case by case basis. if accelerated induction is necessary, an additional dose of - mg can be followed by a further dose if someone has been observed hours after their initial methadone dose. if they are still experiencing withdrawal at this time, they can safely be given a further dose. for buprenorphine, individuals can be rapidly inducted to optimal maintenance doses ( - mg daily). clinicians should consider increasing the dose if the individuals are still experiencing daily cravings, ongoing opioid use, or opioid withdrawal. however, clinicians should be sensitized in the differentiation between withdrawal syndromes, including myalgia, insomnia, sweating, fatigue, and nausea with signs and symptoms of viral covid- infection. pupil size is the best guide to distinguish opioid withdrawal from the symptoms of covid- as this infection does not affect pupil size. it should be possible to see pupil size even with video consultations. although the prescription period of anti-viral treatment is usually less than two weeks and the induction of hepatic metabolic enzymes takes more than the regular time for antiretroviral therapy (art) prescription, the clinicians should be careful about the changes of methadone level in these patients during and more specifically after termination or discharge of the treatment for co-vid- . change from split doses to multiple daily doses is a strategy in patients who receive antiviral therapy. as a result of the induction of methadone metabolism, some patients may need a mild increase in their previous methadone dosage after a few days of initiating antiviral treatment. for buprenorphine, double doses can be given every other day for people who are not considered safe to receive take-home doses. in exceptional situations, some patients on mmt or bmt fulfill the criteria for completion of their ost. termination is a stressful process (berger & smith, ) and needs close supervision and constant consultation. besides, the emotional distress associated with opioid withdrawal may increase the risk of suicidal ideation. termination of mmt and bmt increases the stress, so more attendance at treatment centers are needed, and it is not recommended during the covid- epidemic. some people who use opioids may wish to cease their opioid use during the outbreak, either due to reduced availability of opioids or the difficulty accessing treatment services. the most straightforward approach to detoxification, if available, would be single high dose buprenorphine. doses ranging from to mg have been used for this purpose (ahmadi, jahromi, ghahremani, & london, ) . alternative approaches include clonidine or a combination of symptomatic medications (world health organization, ). individuals with moderate to severe signs of cov-id- infection need medications consisting of a cocktail of art, antimicrobials, and analgesics. these medications may interfere with urine or saliva test results. for instance, quinolones (e.g. moxifloxacin, lomefloxacin, norfloxacin, ofloxacin, ciprofloxacin), rifampin, tolmetin (a non-steroidal anti-inflammatory drug) may yield a false-positive result in opiates urine drug screening (reisfield, goldberger, & bertholf, ). chloroquine demic, the clinicians should assess the benefits of the urinary or saliva testing at this critical circumstance, especially as this will potentially increase unnecessary risks due to close contacts. in this pandemic, it seems that information is spreading more extensively and rapidly in comparison to the sars outbreak in . however, this condition may result in a worsening of public fear, panic, and distress. social isolation may also make individuals susceptible to more psychological distress. consequent economic depression after a pandemic also causes uncertainty and threats to future welfare (strong, ) . the unpredictable future is exacerbated by myths and misinformation that are often driven by fake news and public misunderstanding (bao, sun, meng, shi, & lu, ) . some patients will experience grief over the loss of loved ones. the relationship between adverse life events and brain stress systems have a prominent role in addiction disease (koob, (koob, , (koob, , . pwud are much more vulnerable to stress and crisis followed by lapse and relapse to ex-drug users (goeders, ; koob et al., ; milidvojevic & sinha, ; somaini et al., ) . as a result of stressful events and disasters, mental health problems emerge or exacerbate (farhoudian, hajebi, bahramnejad, & katz, ; farhoudian, rahimi movaghar, rad goodarzi, younesian, & mohammad, ) . in such circumstances, healthy individuals may start drug use (farhoudian et al., ; somaini et al., ) , and several patients may relapse into their previous drug use and start their high-risk behaviors (brandon, vidrine, & litvin, ; farhoudian et al., ; rahimi movaghar, et al., ) . anxiety, worry, depression, irritability, and anger in pwud should be considered as a prodromal sign of lapse or relapse into a new episode of drug use. psychosocial interventions are a vital element in the treatment of pwud, especially in people using stimulants and having mental problems (de crescenzo et al., ) . in this period, internet-based psychotherapy is highly recommended as a replacement. internet consultation, including phone calls, video chat, and short messages, have great potential to make psychological assessment and treatment more cost-effective. computer-assisted therapy appears to be as effective as a face-toface treatment for treating anxiety disorders and depression (taylor & luce, ) . although it requires some equipment and knowledge, it offers a good alternative for more isolated locations, which is relevant in this pandemic. negative emotional states, including fear, anxiety, and boredom, as well as social withdrawal and or isolation, are the main emotions that patients will experience during the covid- pandemic. cbt has been recognized as one of the most beneficial interventions for pwud (lee & rawson, ) . stress reduction as a technique of cbt, either alone or in combination with pharmacotherapies, may prove beneficial in increasing quality of life and reducing cravings and promoting abstinence in clients seeking treatment for sud (goeders, ) . clinicians should help their patients to identify, manage, and reduce their negative emotional states associated with relapse and apply techniques of behavioral activation compatible with specific circumstances of each patient. coping skills training and crisis intervention are the most common types of cbt interventions to be recommended. matrix model is a multi-element package of therapeutic strategies to produce an integrated outpatient treatment experience (rawson & mccann, ; rawson et al., ) . treatment is delivered in an intensive outpatient program primarily in structured group sessions targeting the necessary skills. it is recommended that the meetings could be held individually instead of group format, hoping to lessen the risk of covid- infection. the recommended parts based on the manual (services among iranian people living with hiv and aids: a qualitative study, ) for the period of covid pandemic include: . rp : taking care of yourself; . rp : emotional triggers; . rp : recognizing stress; . rp : reducing stress; . rp : acceptance; . rp : coping with feelings and depression; . rp elective c: recreational activities. incentive-based treatment approaches (i.e. contingency management [cm] ) are effective interventions in reducing addictive behaviors in pwud (ainscough, mcneill, strang, calder, & brose, ; benishek et al., ; lee & rawson, ; messina, farabee, & rawson, ; rawson et al., ) . evidence also supports the cm beneficial effect on the treatment of these individuals targeting infectious disease control (herrmann , matusiewicz, stitzer, higgins, sigmon, & heil, ) . to take advantage of cm in the prevention of cov-id- , the desired behaviors (e.g. washing hands every hour, cleaning hands, etc.) and their scores or prizes (e.g. take-home doses) should be clearly defined and inserted into the list, just like other desired behaviors (e.g. negative urine test). perceived social support from relatives and friends is a major predictor for retention in treatment for pwud shirinbayan, rafiey, vejdani roshan, narenjiha, & farhoudian, ) and the main factor of psychological resilience to disaster (radfar, nematollahi, & arasteh, ; rodriguez-llanes, vos, & guha-sapir, ) . considering the importance of family support, clinicians are advised to engage family and care providers more than ever during the pandemic. attracting other sources of social support such as guaranteed wages and an increase in social security payments will help the individual to pass this period with a better outcome. opioids such as methadone are respiratory depressants, and tolerance develops very slowly and incompletely. when patients under mmt acquire covid- , they should be more closely monitored for both worsening respiratory functions and methadone toxicity. abrupt cessation of methadone must be avoided because anxiety and agitation due to withdrawal syndrome may induce or worsen cardiorespiratory complications (friedman, kamel, perez, & hamada, ; kienbaum, thurauf, michel, scherbaum, gastpar, & peters,, ) . the prevalence of kidney impairment in hospitalized covid- patients is high, and renal insufficiency increases the risk for in-hospital deaths (cheng et al., ) . studies indicate that heroin users, especially pwid, suffer from nephropathy (cunningham, brentjens, zielezny, andres, & venuto, ; do sameiro faria, sampaio, faria, & carvalho, ; may, helderman, eigenbrodt, & silva, ) . other studies confirm that individuals using amphetamine (ginsberg, ertzman, & schmidt-nowara, ; rifkin, ) , cocaine (merigian & roberts, ; norris et al., ; sharff, ) , alcohol (de marchi, cecchin, basile, bertotti, nardini, & bartoli, ; perneger, whelton, puddey, & klag, ) , and potent cannabis (abodunde, nakda, nweke, & veera, ; gudsoorkar & perez jr, ) are more likely to suffer from renal failure. it might be logically concluded that people with a history of drug consumption are more prone to contract renal insufficiency when they are infected to covid- ; however, there is not any revealing evidence so far. evidence suggests that renal insufficiency does not affect the metabolism of methadone in mmt patients (murtagh, chai, donohoe, edmonds, & higginson, ) . despite this issue, patients in acute renal failure due to covid- should be monitored for signs of methadone toxicity because of other reasons for renal insufficiency. heart diseases increase the risk factors of death due to covid- to % in affected individuals with hypertension, . % in diabetics, and . % in patients with other cardiovascular diseases (murtagh et al., ) . individuals with a history of alcohol or drug use are more likely to have cardiac pathology. excessive alcohol consumption (fabrizio & regan, ; mirijello et al., ) , amphetamine (giv, ; o'neill et al., ) , heroin (routsi et al., ) , and cocaine (barton duell, ) are all associated with the increased risk of cardiac pathology. contracting covid- sometimes can result in moderate to severe pain including myalgia, sore throat, and headache that requires pain management. it is recommended that acute pain in pwid with covid- is managed in consultation with pain or addiction specialists. people who use opioids regularly will require additional opioids for the management of pain (athanasos, smith, white, somogyi, bochner, & ling, ; doverty et al., ) . buprenorphine as a high-affinity partial agonist of mu-receptors has an analgesic effect in divided doses, but stops effecting other opioid analgesics and hinders acute pain management in case of necessity (harrington & zaydfudim, ) . in this case, buprenorphine can be ceased and opioid analgesics used or buprenorphine can be continued and non-opioid medications such as clonidine, pregabalin/gabapentin and ketamine can be used (goel et al., ) . health services will need to rapidly adapt to the cov-id- situation. they will need to establish a mechanism of making decisions quickly and under stress, to identifying the essential services to be continued, to develop new mechanisms of patient flow (including screening, batching and referral), to redistribute staff from non-essential roles, and maintaining the continuity of essential supplies (communications, ) . to reduce the risk of transmission, it is generally recommended that nonessential services close, or make their services available by telephone or on-line. when face-to-face services are required, some modifications may need to be made to the service system, for the identification of cases, the protection of staff, the reduction of transmission, and to ensure the continuity of essential services (interim guidline for healthcare facilities, ). when health services remain open in a pandemic, they should first invite all visitors to wash their hands before they touch anything. then they should screen all new visitors with whatever sars-cov- screening mechanism is appropriate for the local conditions. this may include a combination of temperature (where possible measured with a non-touch thermometer), clinical symptoms (cough, shortness of breath, sore throat), and epidemiological criteria (recent travel, contact with cases, health care worker). where, possible, patients meeting the testing criteria should be tested on-site and then directed to isolate themselves awaiting the results. for testing and any subsequent clinical interaction, staff should wear personal protective equipment (ppe) to protect themselves from transmission. if the client is coughing, it is preferable they should also wear a surgical mask (world health organization, c). transmission is through to be mostly via droplet spread when people who are infected sneeze, cough or talk. staff and patients should wash their hands frequently and be careful what they touch. surfaces should be cleaned after they have potentially contaminated. depending on the availability of ppe and the risk in the local community, it may be appropriate for staff to wear masks and gloves, or even gowns and eye protection. patients with symptoms should wear a mask to prevent transmission through cough and sneezing. patients can be divided into three risk groups, those with confirmed sars-cov- virus, patients who meet criteria for testing awaiting test results, and other patients with differing levels of ppe depending on the availability of ppe. preferably, patients with different risk levels should be treated in different parts of the health service. staff and patients should keep a distance from each other (world health organization, c). in addition to providing ost, services should take the opportunity to encourage cessation of smoking by prescription of nrt, and by the distribution of naloxone and overdose resuscitation. in preparation of staff members being sick or isolated awaiting test results, each staff member involved in ost treatment should have at least one other staff member who can continue their role if they are sick. where possible, staff may separate into different teams who have even less contact, so that if one person is sick then the risk of all needing to isolate themselves is reduced (guide on business continuity planning for covid- , february, ). pwud are a marginalized hard-to-reach population living in crowded groups with lower access to healthcare. they usually suffer from poorer health, weaker immune function, chronic infections, as well as various issues with physical and psychiatric comorbidities. consequently, they have a higher risk of contracting co-vid- and its transmission and casualties. we believe that substance use and covid- have a complicated relationship with each other. in summary, we suggest the following items: health authorities should develop and apply specific strategies for pwud for early covid- identification and patient isolation, interrupting transmission, providing appropriate care, attending medical issues, and minimizing negative social impact. health authorities are responsible for providing adequate healthcare for pwuds. they may be required to repurpose and reorient health services through a business continuity team. this team implements evidence-based programs and makes decisions on how the organizations will continue to provide their services. also, they make sure that all ost patients have adequate access to their opioid drugs. treatment sectors should provide essential requirements, as well as software and programs tailored to their own clients' needs. staff may also teach the patients the hygiene rules, self-monitoring for signs of illness, and rapid reporting of the disease in case of occurrence. a mechanism for frequently screening for signs and symptoms of infection should be established. internet and mobile-based social media communications should be considered as the first-line approaches for education and appropriate interventions. opioid users face increased challenges; some concerns are about their take-home doses and repetitive visits that make it impossible for them to stay at home. this pandemic could be considered as an extraordinary circumstance; the clinicians should facilitate ost protocol for clinically stable patients and cancel all group-based interventions or therapies. healthcare workers in substance use treatment facilities are also facing a higher risk of infection, burnout, distress, psychiatric disorders, discrimination, and violence. the essential right for each service provider, no matter a peer group or professional service provider, is to be safe and secure, in both physical and mental health aspects. misinformation, social isolation, ensuing economic depression, and possible grief reactions may result in exacerbation of public fear, panic, and distress that can be followed by lapse and relapse in ex-drug users. stress reduction, crisis interventions, coping skills training, motivational interviewing, and tailored and modified relapse prevention interventions, modification in contingency-based management for rewarding virus transmission preventive behaviours, attracting family support, managing patients' vocational problems are the main helpful psychosocial interventions. in this period, internet-based psychotherapy and phone counseling are highly recommended. there are many medical considerations regarding pwud that other physicians in charge of the management of co-vid- treatment should keep in their minds. clinicians should be careful in the differentiation between withdrawal signs and symptoms and those of covid- infection. pwud may have different clinical manifestations due to various etiologies. healthcare providers should consider different possible manifestations and, more importantly, avoid any type of medical stigma or discrimination against pwud. pwud regularly self-medicate their physical and mental problems with drugs, which may mask critical covid- symptoms. a number of drug-drug interactions between substance of use, addiction treatment medications, and covid- medications must be considered in terms of toxicity, withdrawal, and exacerbation of fatal side effects. there is also a possible overlap of pathological laboratory results of the cbc and liver enzymes in pwud and people with covid- infection. histories of renal failure, cardiovascular and metabolic diseases are more likely to emerge in pwud that put them at higher risk of morbidity and mortality after contracting covid- pain management in pwud, specifically opioid users and patients under ost, has some complexity, which calls for the involvement of joint expertise. the study has been conducted with no funds from external sources. original idea, wrote initial topics and headlines, and the first draft: ali farhoudian and seyed ramin radfar; participated in the literature review, writing, editing, and revision of the report and reached consensus on the conclusion: all authors. the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. we are immensely grateful to dr. richard rawson, professor at integrated substance abuse programs, university of california, los angeles, and dr. richard schottenfeld, senior research scientist at yale school of medicine, for their comments during the process of writing the manuscript. the views expressed are those of the author (s) and not necessarily dr. richard rawson and or dr. richard schottenfeld. authors also respectfully dedicate the article to the souls of all healthcare providers who lost their precious lives in the fight against covid- . cannabinoid 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with acute respiratory distress syndrome. the lancet respiratory medicine cocaine use disorder is associated with changes in th /th /th cytokines and lymphocytes subsets a novel coronavirus from patients with pneumonia in china covid- in wuhan: immediate psychological impact on health workers. medrxiv coronavirus disease (covid- ): a perspective from china key: cord- -wplz o k authors: sanders, chris; burnett, kristin; lam, steven; hassan, mehdia; skinner, kelly title: “you need id to get id”: a scoping review of personal identification as a barrier to and facilitator of the social determinants of health in north america date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: wplz o k personal identification (pid) is an important, if often overlooked, barrier to accessing the social determinants of health for many marginalized people in society. a scoping review was undertaken to explore the range of research addressing the role of pid in the social determinants of health in north america, barriers to acquiring and maintaining pid, and to identify gaps in the existing research. a systematic search of academic and gray literature was performed, and a thematic analysis of the included studies (n = ) was conducted. the themes identified were: ( ) gaining and retaining identification, ( ) access to health and social services, and ( ) facilitating identification programs. the findings suggest a paucity of research on pid services and the role of pid in the social determinants of health. we contend that research is urgently required to build a more robust understanding of existing pid service models, particularly in rural contexts, as well as on barriers to accessing and maintaining pid, especially among the most marginalized groups in society. personal identification (pid) serves multiple and frequently contradictory purposes within the context of the modern state. establishing the identity of individuals by connecting them to key information such as age, sex/gender, birthdate, nationality, and residence, pid has the potential to confer certain rights and privileges on individuals. common forms of pid, like birth certificates, passports, driver licenses, and government-issued health cards, grant access to important benefits, such as health and social services, while non-government pid (e.g., private club membership card, credit cards) typically allow situational access or benefits to the bearer. however, the loss and misuse of personal identity can have devasting consequences for individuals. state record keeping also makes individuals visible to the polity and, thus, governable and subject to the loss of freedoms. recent conversations about the significance of pid and identification security processes, especially since the events of / and the ongoing collection and sale of personal data through large online social media platforms, have largely centered on fears about increased state and corporate surveillance, as well as identity theft and fraud [ ] [ ] [ ] . while it is extremely important to acknowledge that these circumstances have had and continue to have enormous and detrimental impacts on the lives and well-being of individuals and communities, largely overlooked in these conversations is the central role played by pid in accessing essential state services, particularly among people who are socially and economically disenfranchised. taylor and colleagues have astutely described this phenomenon as the inherent ambiguity of viewing citizens as both a "risk to be managed, and thereby an object for surveillance (and) a consumer deserving the best possible public service" [ ] (p. ). after all, without pid it is nearly impossible to access health care, housing, income maintenance, education, banking services, employment, and pension benefits, among other essential programs and services. it is also frequently impossible to access something as simple as emergency food services, like a food bank, without providing government-issued pid and proof of residence. while access to and possession of pid does not of itself guarantee education, health, protection, and participation in society for marginalized people, not having certain forms of government-issued pid ensures that access to essential health, social, and financial services is nearly impossible [ ] . possession of pid, in effect, becomes the gateway to accessing the social determinants of health, particularly in rural settings [ ] . thus, what we refer to as the "problem of personal identification" occurs when populations that are already marginalized and underserved are made further vulnerable because they lack forms of official identification that enable them to secure vital benefits and resources, effectively making them invisible to health and social services. literature on pid in the north american context that does not examine this issue from a security/governmentality perspective tends to focus on populations that are precariously housed or homeless and living in urban spaces. barriers to pid associated with people living in rural and northern settings in north america have not been adequately explored. additionally, relatively little attention is paid to the particular pid challenges experienced by people who are racialized and indigenous, and further, how those identities operate alongside space and gender. these multiple and intersecting identities are important to explore with regard to pid because, as audre lorde points out, "we do not live single-issue lives," [ ] meaning that it behooves us to understand the dynamic ways that lived identities and structural systems intersect to the detriment of the most marginalized individuals and social groups. through this scoping review, we seek to enter into this conversation regarding barriers to obtaining pid by highlighting the ways in which the problems posed by a lack of pid are particularly pronounced for people living in rural, northern, and remote access communities-people whom we already know experience poorer health outcomes than residents in metropolitan and suburban areas, and whom to date have been largely ignored in the scholarship [ ] . further, in canada, indigenous people are more likely to reside in the provincial north and territories than non-indigenous people [ ] [ ] [ ] . given the higher proportion of indigenous people and communities located in rural and remote areas, we contend that health disparities and a lack of access to health and social services resulting from a lack of pid exacerbate inequalities between indigenous and non-indigenous people, broadly speaking. a better understanding of the problem of pid is needed, particularly as it pertains to accessing health and social services for the most marginalized people and groups in society. the aims of this scoping review are as follows: first, to provide readers with a clear understanding of the current research on this topic by providing a comprehensive review and analysis of the academic and gray literatures on the barriers to attaining pid in north america. second, this review aims to show the significance that a lack of pid has for people's ability to access health and social services. third, this review aims to identify gaps in the existing research, particularly in regards to rural and indigenous peoples and communities. fourth, we discuss the implications for rural and indigenous communities and identify future directions for research on pid. scoping reviews aim to provide a survey of studies on or related to a topic rather than to assess the quality of each study. a scoping review was considered an appropriate strategy for this research topic because it was not previously comprehensively reviewed [ ] . this scoping review was conducted following guidelines for scoping studies outlined by colquhoun and colleagues involving a stepwise process of search, selection, extraction, and synthesis of the literature [ ] . a separate protocol for this review does not exist; below, we provide a detailed roster overview of the review process. to ensure the quality of scoping review reporting, we used a checklist developed by tricco and colleagues [ ] . other than the assessment of and secondary analysis of the studies, this scoping review complies with the preferred reporting items for systematic reviews and meta-analyses (prisma) statement and checklist. we use the term "pid" to refer to all types of government-issued personal identification used to recognize citizens and denizens for the purposes of granting access to vital services. common forms of pid include "identity documents" (e.g., birth certificates, passports) and "identity cards" (e.g., driver licenses, provincial health cards, hunting licenses). by contrast, the term "id" includes non-government issued forms of identification (e.g., student body card, private club membership, employment id cards) and may not grant access to vital services provided by the government. we only use the term "id" when quoting studies or in reference to specific identification cards. because existing studies sometimes use these terms interchangeably, or simply use the more common term id, our search strategy employed the term "identification" to search databases. a search string was developed (table ) and used to search the following citation databases: web of science™ (clarivate analytics, philadelphia, pa, usa), core collection (ebsco, ipswich, ma, usa), medline ® (national library of medicine, bethesda, md, usa), cabdirect© (cabi, wallingford, uk), and ebscohost© (ebsco, ipswich, ma, usa). these databases cover health, sociology, anthropology, and psychology disciplines, thereby providing the opportunity to capture the broad literature, as well as approach the research question from different perspectives. no search restrictions were placed (e.g., language, date, publication type). a complementary search for gray literature documents, such as government research reports, was also conducted using a series of simple search strings in google (e.g., "barriers to obtaining identification in north america"). as google returns results based on relevance criteria related to the search term entered, only the first hits of each search were examined [ ] . the reference list of all relevant studies was also hand-searched to identify any further relevant studies not captured in the search. records were uploaded into endnote x ® and de-duplicated. table . search strategy to identify peer-reviewed articles on barriers and facilitators to obtaining identification. identification ("photo identification" or "personal identification" or "government-issued identification" or "civil identification" or "birth identification" or "birth certificat *" or "birth registration" or "photo id") and barriers and facilitators ((barrier * or challenge *) or (facilitator * or opportunit *)) * boolean operator symbol for truncation used to broaden search by capturing all variations of words. the titles and abstracts of studies were screened according to a priori inclusion criteria. to be included in the scoping review, studies needed to report on barriers or facilitators to obtaining pid in the north american context. studies were excluded if they were not relevant to this topic or were not in the english language. in some cases, a full-text review was conducted in order to assess suitability. sources of evidence included primary studies published in english as journal articles, books, research reports, dissertations and theses, or conference proceedings. to ensure the availability of data for charting purposes, we excluded newsletters, news articles, and summaries. we developed and used a charting form to capture data from each study. key information extracted included author, year of publication, country of origin, purpose, publication type, study scale, study population, methodology/methods, and key findings that related to the scoping review question. charting followed an iterative process in which the data were extracted and the charting form was updated continuously. of note, study screening and data charting were done by one author (s.l.), presenting possible concerns over reviewer bias. to address this bias, this author discussed challenges and uncertainties related to the reviewing strategy with the co-authors and refined the approach in the process. the data analysis included quantitative analysis and qualitative analysis. for quantitative analysis, we used descriptive statistics to present the characteristics of the study, methodology, and findings. to characterize and summarize factors which act as barriers to and facilitators of obtaining identification, we used thematic qualitative analysis following a process outlined by braun and colleagues [ ] . first, studies were read in full and notes were written to facilitate data familiarization. then, codes were assigned to portions of the text that discussed identification. we used an inductive approach to coding, with no pre-formulated assumptions of how codes should be defined. similar codes were then grouped into descriptive themes that illuminate patterns in the data across studies. we selected quotations that exemplified these themes and presented them in the results to provide a rich and nuanced description of the data [ ] . to ensure the validity of the qualitative analysis, we held regular discussions among the authors surrounding the developed themes. data were stored in a spreadsheet (excel , microsoft corporation, redmond, wa, usa) to facilitate analysis. the initial search returned studies; after the removal of duplicates and non-relevant studies, a total of studies were included ( figure ). a summary of the descriptive characteristics of these studies is shown in table . the median publication year of relevant studies was (range - ). there was a near equal balance of publications from canada ( %) and the united states ( %). most of the studies were from the academic literature, though a significant portion ( %) were from the gray literature. many of the studies ( %) were purely qualitative and used interviews to collect qualitative data from participants. most studies focused on homeless youth, adults, or people in general ( %, n = ). a detailed summary of the studies, including relevant findings, can be found in appendix a. three descriptive themes were identified across the relevant studies that capture barriers to, and facilitators for, obtaining identification: ( ) gaining and retaining identification, ( ) access to health and social services, and ( ) facilitating identification programs and services. these themes are described in detail below and are supported by illustrative quotations from study participants and/or study authors. one of the biggest challenges identified in the literature that individuals faced was the acquisition and retention of pid. according to many studies ( %, n = ), the main reason people reported for not having identification was that it had been either lost or stolen (e.g., [ ] [ ] [ ] ). this is particularly true for many people who are precariously housed or homeless. campbell and colleagues, for example, conducted one-on-one interviews and focus groups with individuals in calgary that were homeless and health and social services providers in which one participant without housing identified pid as a key barrier: "one of the things i just thought of that could be a potential barrier is missing or stolen id" [ ] (p. ). further support is provided by a survey of people who were homeless in toronto, which found that ( %) were not in possession of their health card [ ] , and in the united states, an estimated % of voting-age citizens lacked identification, with estimates higher among those experiencing homelessness [ ] . additionally, it is common in homeless shelters to have one's personal belongings, where ids and other personal documents are typically stored, taken if left unattended for even a short period of time or while sleeping [ ] [ ] [ ] . consequently, whether living on the streets or staying in a shelter, maintaining possession of one's belongings requires constant vigilance, which is challenging for many people living in precarious circumstances. in addition, many people experiencing homelessness do not possess the means of replacing their pid (e.g., money for fees, knowledge of application process, competency with bureaucratic forms). other studies ( %, n = ) highlighted the requirement of an address or an existing piece of identification in order to apply for additional identification (e.g., [ ] [ ] [ ] ); yet, many homeless people frequently are unable to provide either of these. gordon interviewed people visiting identification clinics in edmonton, alberta, and reflected: "nine people spontaneously told me 'you need id to get id,' or similar words" [ ] (p. ). in a study exploring the lived experiences of adolescent women in seattle who were homeless, the authors reported: [the young women] claimed that the biggest structural barriers to care [that they identified] at many hospitals or clinics not designed for homeless youth were questions over consent for care, being asked to provide addresses and an identification (id) card, and source of insurance or payment [ ] (p. ). still more studies ( %, n = ) emphasized the high cost of obtaining identification (e.g., [ , , ] ). for example, one study from toronto, canada finds: even a modest fee can make it difficult for a homeless young person to obtain identification-and in many states, the cost of obtaining an id card is far from modest [ ] (p. ). for people who are economically marginalized and/or precariously housed, even seemingly minor fees constitute a financial hardship that makes the acquisition of pid prohibitive. in the province of ontario, for example, higher fees are charged for replacement birth certificates, and if people go through "third party" providers rather than state agencies to obtain this form of id, additional service fees are incurred. this means that people who have little or no money and who are likely to lose or have their pid stolen due to being precariously housed are further burdened with higher replacement fees. ultimately, people regularly prioritize the immediate needs of food, transportation, or rent rather than the costs of replacing a lost or stolen document. furthermore, additional costs are required if individuals must take public transportation or live in rural or remote locations and have to travel to service centers. according to a united nations report, the "greater the distance to the registration center the higher the financial costs to the family" [ ] . other scholarship outlined those barriers to obtaining identification that were unique to specific social groups. for example, a lack of legal identity is a barrier among immigrants who are undocumented [ ] . in some us states and canadian provinces, youth are required to obtain the consent of their parents or legal guardians and need to be a certain age in order to apply for identification. for instance, in ontario, youth have to be at least thirteen years of age to apply for many forms of pid on their own behalf, and for youth who are minors and estranged from parents or guardians, age-related restrictions present significant barriers [ , ] and potential danger for those individuals trying to avoid foster care or the return to a less than safe environment. young women who are homeless reported facing judgement and censure from health care providers [ ] . one study also reported stigmatizing attitudes towards people who were homeless in general [ ] . for female sex workers in miami, a lack of space for the storage of identification posed a problem; without storage space for possessions, "women are often assaulted or otherwise robbed of the few goods they own," including their ids [ ] (p. ). in some canadian provinces (e.g., ontario, british colombia, new brunswick), there is a three-month waiting period for a provincial health card for newcomers [ ] , leaving people in a vulnerable position should they require emergency services during the window of no coverage. a few studies ( %, n = ) also reported barriers in the accurate and complete reporting of personal information, like date of birth and the incorrect recording of names and place of birth [ ] [ ] [ ] . a study by melnik and colleagues explored the accuracy of birth data collected in new york state facilities, and found barriers including incomplete information provided by medical staff, birth data located in multiple systems, conflicting birth data from different sources, and inadequate staff resources [ ] . in california, smith and colleagues found the misclassification of ethnicity and race in administrative records in . % and . % of children, respectively [ ] . the authors reported two major causes of this misclassification, including missing information in administrative records and the classification of children of multiple races based on information from only one parent. while many studies ( %, n = ) included the socio-demographic characteristics of participants, such as age, gender, and ethnicity [ , , ] , few attempted to differentiate people's experiences and perspectives that result from these characteristics. for example, adults in toronto who were homeless that participated in a survey included, but were not limited to, % white, % black, and % indigenous [ ] . however, while the study found that % of participants had a health card, it did not indicate whether this outcome corresponded with a particular racial identity. information on which ethnic groups possessed a health card would help inform more nuanced efforts to increase access to identification and health care more generally. a notable exception where this information was included is a qualitative study in edmonton, where % of interviewees (n = ) were estimated to be indigenous, with the majority being men [ ] . the study found that indigenous men and women experienced more barriers to identification on average compared to non-indigenous men and women. in a different study from california, smith and colleagues found that children of minority groups are more likely than non-minority groups to experience the misclassification of ethnicity and race in administrative records, presenting possible consequences for data misinterpretation and over/underestimated health disparities, as well as presenting further difficulties later in life if and when people have to replace their pid [ ] . the challenge posed by pid was further exacerbated for sexual minorities, particularly transgender individuals [ , ] . in a study exploring the lived experiences of transgender youth that were homeless in new york city, many either did not have identification or had identification documents that did not match their self-designated gender and presentation, resulting in "transgender and gender expansive young people facing harassment and discrimination when applying for jobs" [ ] (p. ). following from the inability to acquire or maintain pid are the social and health consequences that directly result. the lack of identification was reported by many studies ( %, n = ) as a factor impacting the ability of individuals to access health services (e.g., [ , , ] ). for example, one provider in calgary, canada reported: identification is something that you often need when you go to clinics and a lot of our [clients] do not have id-whether or not they even have alberta health care cards with them or have even applied for their alberta health care cards. we have a lot of out-of-province clients that come through, a lot of immigrants that come through so then that whole issue is do they even get access to certain types of care just due to not having the proper documents [ ] (p. ). a lack of pid becomes both a direct and indirect barrier to accessing services. in ontario, for example, residents must present an ontario health card in order to receive benefits through provincially funded health coverage [ ] . to receive a health card, however, an individual must provide three key documents (proof of citizenship, proof of ontario residency, and some form of personal identification from a specified list), which poses significant difficulties for people with precarious housing. bureaucratic structures with onerous requirements for applying for pid can further complicate matters for many people. in a qualitative study involving youth in los angeles who were homeless and drug-dependent, the authors reported: perhaps surprisingly, structural barriers cited by the youth stemmed not from a paucity of agencies or resources but conversely from the presence of too many agencies with endless bureaucratic requirements involving interagency referrals, the need for identification cards, time-consuming paperwork, and lack of continuity of care [ ] (p. ). this was also echoed in a qualitative study involving young women in seattle experiencing homelessness: so you have to go to a regular clinic and they take forever to register you and they want to know why you don't have insurance and then they make you sit there another minutes until they call someone to figure out what it is. i've had so many bills from places like that so many notices. i always told them from the beginning, 'i'm homeless. i don't have an id. you can't call my parents; they will not say they're my guardians. they will not take responsibility for me. i don't have insurance.' you know-it's like, 'can you please? i'm bleeding here -can you help me'? [ ] (p. ). according to some studies ( %, n = ), government-issued identification is also required to access food banks (e.g., [ , , ] ). a survey of service providers across us states found that when individuals who were homeless could not provide photo identification, % were denied food stamps [ ] . another survey of homeless adults in downtown toronto reported that % of adults that were homeless were unable to access the food bank due to a lack of identification [ ] . in new york city, out of the ( %) food pantries surveyed had an identification requirement [ ] . in an unnamed city in the us, individuals living with mental health disabilities and facing homeless were found to face further challenges to accessing services as a result of the lack of pid: returning offenders who have mental illness are often eligible for several public assistance programs, including general assistance, food stamps, and medicaid. in the state where the study site is located, all such programs are administered by the state's public assistance department, which also oversees the application process and thereby controls access to services. identification requirements are a central feature of the application process, and these requirements emerged early in the study as a source of problems for clients" [ ] (p. ). indeed, a lack of pid was identified by several studies ( %, n = ) as a serious barrier to accessing social housing and income support (e.g., [ , , ] ). for example, the lack of personal identification was reported as a barrier of many people who were either homeless or precariously housed that were applying to the ontario disability support program [ ] . in a survey of adults in toronto that were homeless, ( %) reported that the lack of pid was the main reason for remaining homeless [ ] . suggestions for reducing barriers to accessing health and social services include: welcoming other forms of identification (e.g., non-government issued identification) [ ] , providing alternative verification processes for proof of identity or residence (e.g., allowing people who were homeless to use the address of a shelter as their mailing address) [ , ] , building mechanisms to improve access to services that do not require individuals to present identification (e.g., databases that transfer medical data between sites) [ , ] , building the cultural competencies of health care providers [ , , , ] , and improving the access and availability of information on how to obtain identification and reducing or eliminating fees [ , ] . finally, a number of studies exploring pid facilitators ( %, n = ) recommended funding programs at social service agencies to support the replacement and storage of identification [ , , , ] . kopec and cowper-smith described four organizations in canada that provide a space to store identifications (sometimes referred to as "id banks") [ ] . most of these organizations also help clients apply for their identification and cover the associated fees. similarly, goldblatt and colleagues described two identification programs that provide a mix of support services at no fee [ ] . in one case, the regional municipality of york region in ontario provides a mailing address for clients when necessary, delivers identification to clients, and connects individuals with other services such as housing, food resources, and financial support. in the second case, the city of toronto provided funding to support the id bank located at street health. other studies argued that id fees for people who were homeless should be waived [ ] [ ] [ ] [ ] . in one state, south carolina, people that were homeless were not required to pay fees associated with pid: in order to get a fee waiver, a homeless person provides a letter from a shelter employee or other service provider indicating that he is homeless and requesting a fee waiver [ ] (p. ). within the modern bureaucratic state, personal identification serves many, often contradictory, purposes. on the one hand, establishing identity can connect individuals to vital health and social services, while, on the other hand, the theft and misuse of identity can have devastating consequences, ranging from breaches in personal privacy and financial fraud to the loss of democratic freedoms when governments use personal data to surveil individuals and populations. recent conversations about pid have tended to focus on the latter issues, precipitated mainly by the events of / and recent high-profile cases of cybertheft and the sale of personal data by major corporations. while it is important to acknowledge the validity of these concerns, this scoping review focuses on the former issue by drawing attention to the central role played by pid in accessing essential state services, particularly among the most socially and economically marginalized people and groups in society. we started this research prior to the outbreak of, and public health response to, the covid- global pandemic, an event that makes it more apparent than ever how a lack of pid impacts access to the social determinants of health for the most marginalized people in society. at the time writing, local emergency food banks require valid identification, not only for the individual directly receiving the food, but for everyone living in the household [ ] [ ] [ ] . many people simply do not have access to pid documents and information at this tumultuous time, let alone are they able to afford the cost of a pid application at the moment. marginalized people without pid are unable to travel home by air or bus, nor can they access many emergency housing supports, as these options all require pid, leaving some with no alternative but to live on the streets where physical distancing and other protective measures, like hand-washing, cannot be practiced [ ] . government service centers that normally process pid applications have limited both their business hours and their provision of services [ ] , and while these measures are important in helping to flatten the curve of covid- , they also further marginalize people in need of emergency services by making it exceedingly difficult to obtain pid at a time when it is needed most. the results of this scoping review illustrate the paucity of research on what may be termed the "problem of personal identification," especially in regards to the barriers and facilitators faced by groups that are particularly marginalized in the acquisition and retention of pid. our review also finds that the existing research, while limited, focuses primarily on people who are either homeless or precariously housed; to a lesser extent, the review also finds that sex workers and select sexual minorities face significant pid challenges, namely transgender people. it is also worth pointing out that almost one-third of our results come from the gray literature, in the form of reports and policy briefs produced by nonprofit organizations, like street health in toronto, canada. this suggests that a significant portion of the work on pid is being conducted by frontline organizations and that more academic involvement could support these organizations to study the issue more comprehensively. among the most common barriers to pid, the scoping review finds that homelessness creates obstacles to the acquisition of pid, as often an address is required to apply for pid, as well as to maintaining the possession of pid, as theft of and damage to personal belongings is an ever-present problem. another key barrier associated with a lack of pid is an inability to access social and health services, which, in turn, makes people who are marginalized further vulnerable by limited access to the social determinants of health; this problem is particularly marked among women and youth. finally, regarding facilitators, the review finds that identification programs, such as "id banks," are positively associated with people's ability to acquire and maintain pid. these findings highlight important sociological interactions, ranging from economic deprivation and homelessness to gender and sexual identity, that contribute to people's ability to acquire or maintain key forms of pid that are the gateway to accessing vital services. another notable finding of the scoping review was a pointed statement shared by several interviewees of one study: "you need id to get id . . . you can't do anything without id" [ ] (p. ). this reality speaks to the importance of birth registration and maintaining the possession of a birth certificate. in canada, for instance, a birth certificate is required to acquire most forms of identification, such as a social insurance number (sin) or an indian status card, which is required under the indian act to confirm the indian status of indigenous people. even for forms of pid that do not directly require a birth certificate, such as an ontario health card or driver license, a birth certificate is necessary to get the prerequisite identification needed to apply for a health card or driver license. thus, in canada, as in many other nations, the birth certificate becomes the foundational piece of pid that enables access to all other identification documents. that many pid applications require a permanent residence in order to be issued becomes a "catch " situation of sorts, wherein people who are precariously housed require a home in order to obtain pid that will enable them to access housing or health and social services. conspicuously absent from the existing literature was research that focused on northern and rural populations, indigenous people, and the relationship between the two. in canada, for instance, indigenous people make up a significant proportion of the population in the rural and provincial north, and further clarity is needed on the unique pid problems facing this population, such as birth registration and the acquisition of birth certificates, as well as the difficulties of obtaining pid in areas with extremely limited access to state social and health services [ ] . our preliminary work, for example, has shown that % of the clients seeking birth certificates and other forms of pid in thunder bay and the surrounding district identify as indigenous [ ] , indicating that this is an important area of further study. likewise, the structural barriers that exist in fly-in and road access first nations have not been addressed, nor is there any sustained analysis of the historical and ongoing impacts of settler colonialism on access to and the meaning of pid. although a few studies identified the reporting of inaccurate birth information by medical staff or other administrative personnel as a barrier to acquiring pid, the particular experiences of indigenous peoples in the north and the implications have not yet been fully fleshed out. for instance, indigenous children forced to attended residential schools frequently had their names changed, misspelt, or dates of birth recorded incorrectly [ ] . records of these activities, which would help substantiate claims of identity, have often been lost to fires and flooding that frequently occur in rural settings. that this is a historical problem, dating back to the s, means that elders from rural areas are even less likely to have access to original documentation required to acquire pid. furthermore, these problems have persisted for indigenous children, who continue to be removed from their families and communities at alarming rates by child welfare agencies. in canada, indigenous children account for % of the children in foster care, while constituting only . % of the canadian population [ ] . the fear of possible child apprehension may also pose a further barrier to birth registration for indigenous peoples, if parents are afraid to report new births [ , ] . long histories of settler violence enacted through systems of education, health care, policing, and child welfare have ensured that indigenous people and communities have been over-policed and under-serviced by the state. as a result, mechanisms, like birth certificates and other forms of pid, which make citizens visible to state structures and services, can often be problematic and fraught with anxiety and distrust for indigenous people. more research is also needed on the implementation and use of "id banks" as a facilitator for acquiring and maintaining pid. storage programs are particularly promising for people who are homeless, especially as the conditions of living unhoused frequently leads to the damage and permanent loss of pid [ , ] . such programs exist in different forms in urban areas, offering a variety of storage options for pid. options include the storage of original copies of pid, official duplicates, and unofficial photocopies, as well as the storage of digital copies on secure servers. in some instances, an unofficial photocopy of pid may be adequate to prove personal identity or, at least, to begin the process of applying for certain services contingent upon the client returning with the original identification document to complete the process. in other cases, agencies that host id banks can also be contacted to vouch that the photocopy is accurate and on file; this model can be particularly effective among partnering agencies or those with a memorandum of understanding (mou) for specific issues. importantly, there are examples of agencies that work with people who are homeless to create their own form of "agency id card" for clients, which is recognized by local law enforcement due to the agency's reputation (e.g., street health in toronto, on, canada). furthermore, some agencies with id banks have staff with registered notary status, enabling them to make notarized copies of pid on site. a staff member who can serve as a notary alleviates one more complicated, if not costly, step, as notary services can be prohibitive for people who are economically disadvantaged. using an id bank service means that clients know their pid is safely stored and can be accessed during agency business hours (or whatever access schedule is in place). some agencies also serve as a mailing address where clients may have identification documents sent for official receipt and safe storage. id banks may be one way that frontline service agencies with extremely limited resources can begin to address the pid problem among their clientele. research on this topic should focus on the structure and design of id banks, common/best practices, who uses them and why, which agencies have established them and to what effect, and barriers to implementation. it is also important to further explore the ways in which different national and provincial/state jurisdictions and policies affect the implementation and design of id banks. if the process of instituting an id bank is too costly or bureaucratically onerous, many community agencies with limited resources will be deterred from attempting to provide this important service. finally, it is important to better understand the implementation and use of id banks in rural areas, as the current literature deals exclusively with urban settings. it is important to consider the potential risk of bias within this review. first, this scoping review was limited to english-language articles, which most obviously biases findings toward higher income western nations but also, in the case of canada, excluded francophone areas like quebec. while many of the themes identified in the literature are likely national and therefore also exist in quebec, pid barriers and facilitators that are particular to that province require further investigation prior to the development and implementation of federal policy. second, in general scoping reviews, including this one, do not evaluate the methodological quality of the studies nor the quality of the evidence, but rather focus more broadly on the outcomes presented by the studies [ ] . third, a further limitation of this study was the decision to limit the scope of analysis to pid in north america. this decision was anchored in our particular research project that examines the pid experiences of indigenous people in canada and the us-nations that have similar policies and practices. undoubtedly, expanding the scope of the analysis to include places like europe and australia, for example, would shed additional valuable light on the experiences of other marginalized groups, including ethnic minorities and refugee and migrant communities, as well as the bureaucratic practices of other nations with respect to pid. finally, as with any scoping review, some literature may have been missed as a result of the keyword search strategy and the limitations of the selected databases, which may, for instance, limit the ability to locate key gray literature. the google search alone, for example, might not capture all of the relevant gray literature [ ] . for a more comprehensive analysis, future analyses might look at websites of key organizations or contact organizations to inquire if they have unpublished sources available. nevertheless, this scoping review is rigorous and provides insights into some of the pid key barriers and important facilitators in north america. this scoping review is the first step toward investigating the problem of pid through an intersectional lens. our findings indicate that pid is an important influence on the ability of people who are marginalized to acquire and maintain pid that, among other things, enables access to the social determinants of health. it is our position that a more complete understanding of the barriers and facilitators to pid is imperative, particularly in different local, regional, and national contexts, as well across a diverse range of social identities. such research will benefit multiple disciplines in the social and health sciences and nursing, as well as policy-oriented fields. interweaving this understanding with a more sophisticated understanding of the social determinants of health would further highlight ways that poverty and social factors, like racism and colonialism, help reproduce one another. this would not only provide a more nuanced understanding of the problem of pid, but contribute to evidence-informed policy aimed at ameliorating the problem and improving health outcomes among people that are the most underserved and marginalized in society. the authors declare no conflict of interest. the funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. appel explore common sources of advice, health-seeking behaviors, and access to care issues of homeless adolescent women participants said that the biggest structural barriers to care at many hospitals or clinics not designed for homeless youth were questions over consent for care, being asked to provide addresses and an id card, and source of insurance or payment identity crisis: how identification is overused and misunderstood playing the identity card: surveillance, security and identification in global perspective protecting and proving identity: the biopolitics of waging war through citizenship in the post- / era identification practices in government: citizen surveillance and the quest for public service improvement birth registration: right from the start. innocenti dig a case study in personal identification and social determinants of health: unregistered births among indigenous people in northern ontario sister outsider: essays and speeches health in rural canada the embodiment of inequity: health disparities in aboriginal canada indigenous health part : determinants and disease patterns social transformations in rural canada: community, cultures, and collective action scoping studies: towards a methodological framework scoping reviews: time for clarity in definition, methods, and reporting prisma extension for scoping reviews (prisma-scr): checklist and explanation applying systematic review search methods to the grey literature: a case study examining guidelines for school-based breakfast programs in canada thematic analysis. in handbook of primary healthcare needs and barriers to care among calgary's homeless populations universal health insurance and health care access for homeless persons it takes id to get id: the new identity politics in services restrictive id policies: implications for health equity risk factors, endurance of victimization, and survival strategies: the impact of the structural location of men and women on their experiences within homeless milieus perspectives of homeless people on their health and health needs priorities more sinned against than sinning? homeless people as victims of crime and harassment meeting the health care needs of female crack users: a canadian example expanding id card access for lgbt homeless youth policy brief on government identification community, use it or lose it? anthropologica barriers and bridges to care: voices of homeless female adolescent youth in national law center on homelessness & poverty. photo identification barriers faced by homeless persons: the impact of the 'rights' start to life: a statistical analysis of birth registration healthcare access and barriers for unauthorized immigrants in el paso county national network for youth. a state-by-state guide to obtaining id cards barriers to health and social services for street-based sex workers i spent nine years looking for a doctor': exploring access to health care among immigrants in association of missing paternal demographics on infant birth certificates with perinatal risk factors for childhood obesity barriers in accurate and complete birth registration in new york state. matern health plan administrative records versus birth certificate records: quality of race and ethnicity information in children access to primary health care among homeless adults in toronto, canada: results from the street health survey transgender youth homelessness: understanding programmatic barriers through the lens of cisgenderism barriers to enrollment in drug abuse treatment and suggestions for reducing them: opinions of drug injecting street outreach clients and other system stakeholders the health bus: healthcare for marginalized populations attitudes of homeless and drug-using youth regarding barriers and facilitators in delivery of quality and culturally sensitive health care the street health report. the street health report. the health of toronto's homeless population food insecurity: limitations of emergency food resources for our patients final report: systemic barriers to housing initiative failing the homeless: barriers in the ontario disability support program for homeless people with disabilities; street health barriers to care: the challenges for canadian refugees and their health care providers physician payment for the care of homeless people toronto report card on housing and homelessness; city of toronto guelph-wellington taskforce for poverty elimination: avenues for creating an id bank greater vancouver food-bank users will soon need to prove low-income status food bank deals with location change. the chronicle journal sudbury food bank updates guidelines for new users can't go home: no id strands indigenous man on vancouver's downtown eastside. cbc ottawa shuts service canada centres after employees refuse to work. the globe and mail the challenges of accessing personal identification in northwestern ontario national centre for truth and reconciliation (nctr) aboriginal peoples in canada: first nations people, métis and inuit, part living arrangements of aboriginal children province reports st decrease in child welfare numbers in years child apprehension laws to be amended so kids can't be taken because of poverty the struggle to end homelessness in canada: how we created the crisis, and how we can end it. open health serv can i see your id? the policing of youth homelessness in toronto advancing scoping study methodology: a web-based survey and consultation of perceptions on terminology, definition and methodological steps harm reduction through a social justice lens key: cord- -hend ale authors: klaus, joachim; gnirs, peter; hölterhoff, sabine; wirtz, angela; jeglitza, matthias; gaber, walter; gottschalk, rene title: disinfection of aircraft: appropriate disinfectants and standard operating procedures for highly infectious diseases date: - - journal: bundesgesundheitsblatt gesundheitsforschung gesundheitsschutz doi: . /s - - - sha: doc_id: cord_uid: hend ale for infectious diseases caused by highly pathogenic agents (e. g., ebola/lassa fever virus, sars-/mers-cov, pandemic influenza virus) which have the potential to spread over several continents within only a few days, international health protection authorities have taken appropriate measures to limit the consequences of a possible spread. a crucial point in this context is the disinfection of an aircraft that had a passenger on board who is suspected of being infected with one of the mentioned diseases. although, basic advice on hygiene and sanitation on board an aircraft is given by the world health organization, these guidelines lack details on available and effective substances as well as standardized operating procedures (sop). the purpose of this paper is to give guidance on the choice of substances that were tested by a laboratory of lufthansa technik and found compatible with aircraft components, as well as to describe procedures which ensure a safe and efficient disinfection of civil aircrafts. this guidance and the additional sops are made public and are available as mentioned in this paper. since there are flight connections to nearly all regions of the world, health protection authorities of all countries must focus on the problem of epidemic spread via civil aviation. fortunately, it does not happen often that passengers become infected by contagious co-passengers [ ] . nevertheless, we have to expect that contamination of an aircraft through infected passengers is a realistic scenario. to date there are no mandatory guidelines from who for disinfection of aircrafts in case of highly pathogenic agents. in recent cases of infectious diseases caused by highly pathogenic agents (e. g., ebola fever virus, lassa fever virus, sars-cov, mers-cov, pandemic influenza virus) which have the potential to spread over several continents within only a few days, international health protection authorities took measures -which are, in part, of high economic relevance -to limit the consequences of a possible spread [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the measures taken did not in all cases reach the intended objective or were more or less inefficient considering the effected expenditure [ , ] . therefore, it is necessary to examine mechanisms and relevance of such transmissions in relation to international public health. the results will enable us to deduce whether measures must be taken and which ones would be necessary to limit the spread of various, highly pathogenic and life-threatening infectious diseases [ , [ ] [ ] [ ] [ ] . if passengers infected with diseases that have the potential to become a public health emergency of international concern use public transportation (i.e., aircrafts), there is a potential threat to the destination area and -depending on the route of infection -for passengers travelling with the same aircraft [ , , , , ] . based on the framework of the international health regulations, a number of recommendations, standard procedures, and guidelines focusing on the operational needs of civil aviation have been published. basic advice on hygiene and sanitation on board an aircraft is specified by the "guide to hygiene and sanitation in aviation", published by the who [ ] . nevertheless, the who guidelines lack details on available and effective substances as well as standardized operating procedures (sop). in addition, national legislation or manufacturers' guidance is lacking. every aircraft undergoes cleaning based on a standard cleaning procedure (sop) prior to the next departure. in case of a suspicious or confirmed passenger suffering a highly infectious disease (hid), a special, additional disinfection of the aircraft is mandatory. for this purpose, all used disinfectants must be aircraft component compatible, i. e., must not have any negative effects on individual parts or the structure of the aircraft, while also fulfilling national healthcare requirements [ , ] . when choosing a disinfectant, it must be ascertained that their application will cause neither short-nor long-term damage to the aircraft structure (i.e., corrosion), electronics and avionics (i.e., insulation of cables), sensors (i.e., smoke detection), interior (i.e., installations, seats, monitors, media devices, windows, galleys, countertops, restrooms). apart from obvious aspects of health, internationally accepted requirements and specifications of authorities, the financial aspects of airlines must be taken into consideration. concerns are delays and rebookings, flight cancellations and additional accommodation of passengers, ferry flights, and storage/transport of material and equipment for disinfection (dangerous goods). the purpose of this paper is to fill in these gaps and to give guidance on a selection of substances that were tested and found compatible with aircraft components, as well as to describe procedures that ensure a safe and efficient disinfection of civil aircrafts. this guidance and these additional standard operating procedures (sop) are made public and are available as indicated in the references [ ] or via qr code/ link as shown in . fig. . in , the lufthansa group (lufthansa german airlines, austrian, swiss, lufthansa cargo and others) operated a worldwide network with destinations in countries and carried outover one million flights, transporting nearly million passengers. lufthansa considers it as absolutely necessary to implement the sops in accordance with local health protection authorities to ensure international air traffic without interruption. the airline will apply these sops worldwide and would like them to be accepted by all sides (. fig. ). since expert attention to incidents and accurate procedures vary greatly in different countries, lufthansa implemented specific sops and information which comply with guidelines of authorities and airline interests as well as the international air transport association (iata). these sops include procedures for cockpit crew, cabin crew, passengers on board aircrafts, on board, ground, authorities communication, local health protection authorities, disinfectors, maintenance and handling personnel, airport partners, and shall provide the safe and hygienic operation of the aircraft. the process should be kept as simple and cost efficient as possible for all concerned parties, such as local authorities, affected airlines, and airports. the goal is to reach a conclusive, internationally accepted medical and legislative procedure for disinfection which enables a safe, rapid, and cost effective further utilization in case of a passenger with a highly infectious disease on board any civil aircraft. the authors took these critical topics into consideration and worked closely with local health protection authorities (hpa) as well as colleagues from the frankfurt international airport (fra-port ag) while testing different disinfectants and techniques before implementing them. lufthansa technik ag (lht) is a wholly owned subsidiary of lufthansa german airlines. it is an internationally licensed maintenance, production, and development organization and is an authorized design organization (design organization approval certificate easa. .j. ). therefore, lht is authorized to test the use of disinfectants and related procedures in aircraft interiors based on international, standardized testing methods. in lufthansa technik central laboratories, a comprehensive evaluation was bundesgesundheitsbl · : - doi . /s - - - © the author(s) . this article is available at springerlink with open access. abstract for infectious diseases caused by highly pathogenic agents (e. g., ebola/lassa fever virus, sars-/mers-cov, pandemic influenza virus) which have the potential to spread over several continents within only a few days, international health protection authorities have taken appropriate measures to limit the consequences of a possible spread. a crucial point in this context is the disinfection of an aircraft that had a passenger on board who is suspected of being infected with one of the mentioned diseases. although, basic advice on hygiene and sanitation on board an aircraft is given by the world health organization, these guidelines lack details on available and effective substances as well as standardized operating procedures (sop). the purpose of this paper is to give guidance on the choice of substances that were tested by a laboratory of lufthansa technik and found compatible with aircraft components, as well as to describe procedures which ensure a safe and efficient disinfection of civil aircrafts. this guidance and the additional sops are made public and are available as mentioned in this paper. air traffic · highly infectious diseases · disinfection of aircraft · standardized operating procedures · substances for disinfection luftverkehr · hochansteckende krankheiten · desinfektion von flugzeugen · standardverfahren · produkte zur desinfektion performed to confirm the compatibility of aviation materials with substances and agents for surface treatment and cleaning. with a broad variety of tailored lht evaluation programs, producers, suppliers, and users can check, prove, and substantiate that subject agents do not cause damage or compromise the airworthiness of the aircraft and its components. for the disinfection process several products have been determined as useful accord-ing to officially nominated disinfection methods [ ] . thus, lufthansa technik central laboratories tested several agents regarding harmful effects when applied to specific aviation materials and in compliance with aircraft specifications such as boeing d - , evaluation of airplane maintenance materials, or airbus aims - - , evaluation of maintenance materials. the products taken into service are belonging to to the family of alcohol-based agents, formaldehyde-based agents, and oxygen-releasing disinfectants. the use of formaldehyde-based agents reveals an increased ablation of magnesium, which shows that it can be used for single purposes, but not for regular interval cleaning. based on the testing, the group of oxygen-releasing disinfectants shall not be used on surfaces with magnesium due to a high risk of material corrosion and on seals because of the possibility of embrittlement and consecutive malfunction. alcohol-based disinfectants were tested without any restriction. nevertheless, it must be noted that alcoholbased agents are flammable and the explosive level has to be closely observed during their use. it is mandatory to refer to the hid form from lufthansa technik [ ] or via the qr code/link as shown in . fig. . multiple test procedures were used to examine the interdependencies between typical aviation materials and the substances tested. the lht central laboratories provide services to perform the tests in its chemical and metallographic laboratories and also according to specific standards of lufthansa, boeing, airbus, american standard methods (astm), etc. they tested effects on aircraft materials such as metal, glass, electric conduits, synthetics, leather, and fabric seat covers, windows, and monitors. all disinfectants are approved by the airline engineering and can be used on the lufthansa fleet. gathered results deviating from common aircraft manuals, for example, the aircraft maintenance manual (amm), are documented in the lht standard practices manual (spm), which is mandatory for the lufthansa fleet and, if accepted, for clients. with regard to the sops, different procedures are defined and reduced to simple, reproducible processes [ ] . the following procedures were developed and already implemented within the lufthansa fleet by: integration into manuals for cockpit crews information on notification procedures to air traffic control and operational control center (occ), for cabin crews, for passengers, for health protection authorities at port of destination (pod) or port of entry (poe), on products and generics, for disinfectors, for aircraft maintenance and ground personnel, and for release to service (rts). the above-mentioned procedures are available at lufthansa destinations worldwide, published in the station emergency reaction plan (serp). the sops are available in a document on board dlh aircrafts (available for technical/expert groups (see [ ] or via qr code/link as shown in . fig. ) ). because of a lack of internationally accepted requirements for a suspected or confirmed cause of hid, airlines cannot fall back on coordinated, authorized, and internationally approved procedures. therefore, the necessity arises to discuss the way how infectious diseases are handled on board aircrafts, standardize disinfection, define "aircraft component compatible" disinfectants and procedures, and establish a safe onward flight operation. only a small number of disinfectants were chosen to facilitate worldwide transportation and the storage of necessary products with tested component compatibility as well as to reduce the complexity of the matter. products were selected based on the components formaldehyde, hydrogen peroxide, and alcohol. these components are effective against hid and they are aircraft component compatible if used properly. in addition, they are available worldwide. formaldehyde, hydrogen peroxide, and alcohol allow the varying techniques of standard disinfection of surfaces. lufthansa technik, with its certification and expertise, is able to disinfect and to certify the affected aircrafts for release to service effectively and in a time-efficient manner. the past has shown that the negative consequences of missing or uncoordinated procedures could be immense. abilities and capacities of major airports and involved health protection authorities could be quickly exceeded. thus, it is highly urgent to define global measures and procedures to ensure that all involved players worldwide coordinate and accept them. in case of an emergency, being well prepared will ensure optimal processes while minimizing the rate of errors. as a consequence of this, lufthansa german airlines developed together with the german competent authorities a high infectious diseases (hid) form which is also available for technical/expert groups via email (frapxo@dlh.de). screening for infectious diseases at international airports: the frankfurt model risk of severe acute respiratory syndrome-associated coronavirus transmission aboard commercial aircraft an outbreak of influenza aboard a commercial airliner emerging infectious diseases including severe acute respiratory syndrome (sars): guidelines for commercial air travel and air medical transport passenger health -the risk posed by infectious disease in the aircraft cabin forecast and control of epidemics in a globalized world spread of a novel influenza a (h n ) virus via global airline transportation transmission of influenza on international flights epidemiology, transmission dynamics and control of sars having and fighting ebolapublic health lessons from a clinician turned patient guide to hygiene and sanitation in aviation coordinated public health surveillance between points of entry and national health surveillance systems highly infectious diseases form revision ; - accessible via e-mail: frapxo@dlh.de . who ( ) guide to hygiene and sanitation in aviation liste der vom robert koch-institut geprüften und anerkannten desinfektionsmittel und -verfahren key: cord- -c y zf o authors: opitz, sven title: regulating epidemic space: the nomos of global circulation date: - - journal: j int relat dev (ljubl) doi: . /jird. . sha: doc_id: cord_uid: c y zf o after the severe acute respiratory syndrome (sars) outbreak in , legal theorist david fidler diagnosed the arrival of the ‘first post-westphalian pathogen’. the coinage indicates that the spread of infectious disease transforms the spatial coordinates of the modern political environment. this article analyses this transformation by asking how the legal regime, designed to prepare for the pandemic, envisions the globe as an object of government. it demonstrates that the who’s international health regulations (ihr) articulate a space of global circulation that exhibits two features. first, the infrastructures of microbial traffic become the primary matters of concern. the ihr do not focus on human life so much as they aim at securing transnational mobilities. second, the ihr circumscribe a space that is fragmented by zones of intensified governmental control at transportational nodal points, such as airports and harbours. in these zones, technologies of screening and quarantine are applied to modulate the connectivity of people, organic matter and things. as a whole, the article investigates how processes of de- and re-territorialisation interact in the context of global health security. in analysing forms of legal worldmaking, it unearths a nomos of global circulation which applies its regulatory force to the post-human materialities of microbial traffic. 'world-making', david delaney ( delaney ( , has introduced the notion of the 'nomosphere ' ( - ) . the term is derived from the greek nomos that relates to acts of division, separation and demarcation. most famously, these connotations have assumed centre stage in carl schmitt's ( ) nomos of the earth. in this book, schmitt traces the geopolitical contours of the international order enshrined in the jus publicum europaeum. unlike schmitt, however, delaney does not assume a mythological foundation of law in 'concrete spatial orders'a view most palpable in schmitt's portrayal of the earth as the element that 'contains' and 'sustains' law (schmitt : ; dean ) . rather, delaney seeks to highlight how law is constitutively involved in the articulation of always contingent spatialities. accordingly, this article wants to look at how the ihr become imbricated in the production of our spatial present. undertaking such 'nomospheric investigation', however, does not imply that legal documents shape the political cartography single-handedly in a causal way. they are but one element in the material practices that configure the spatial setup of global governmental assemblages (collier and ong ; valverde ) . theoretically, the following argument engages with foucault's genealogy of liberal government (foucault ; valverde ) . foucault is important in this context since he is one of the few thinkers who have emphasised the inherent connection between political rationalities, space and infectious disease (legg ) . for him, the history of modern political power is, to a large extent, a history of how epidemics were dealt with. diseases such as leprosy, plague or smallpox gave rise to specific modes of spatial ordering that correspond with specific technologies of governing. this article adopts this perspective for understanding the making of 'nomospheres'. it looks at the legal document of the ihr as an operative device in the fabrication of governmental spaces, which are supposed to provide security against the pandemic threats to come. the analysis will show that the ihr entail a modulation of what foucault has described as the governmental rationality of planetary circulation. two particular nomospheric features encoded in the ihr stand out in this respect. the first concerns the referent object of governmental practice: the regulatory effort to secure global public health does not focus on human life so much as it does on post-human materialities of global traffic. infrastructures and objects of mobility are its main concern. the second feature pertains to the particular type of territorial control envisioned under the current conditions of intense globalisation. for governing 'viral traffic', the ihr stipulate technologies such as screening and quarantine, which supplement the liberal image of a smooth and borderless world. these technologies re-territorialise the planetary space by forming thresholds at which the movement of risky bodies is interrupted and rhythmicised. the ihr thus constitute a 'nomadic nomos' (vismann : ) that incorporates territorial strategies into the government of the networked topologies generated by global traffic. for developing this argument, the article proceeds in three steps. the first section reconstructs the relationship between epidemic crisis and the emergence of spatial orders to be found in foucault. unfolding this heuristic framework for the subsequent analysis of the ihr, it elaborates especially the role that legal concepts play in translating the idea of liberal circulation into the global sphere. against this background, the second section investigates the peculiar mode in which the ihr constitute a nomosphere of global circulation. it traces the shifting concern from the health of the individual and the population towards a continuum of organic and inorganic bodies travelling along infrastructures of transmission. the third section focuses on the role played by technologies of thermal screening and quarantine in this peculiar rationality of governing circulation. it presents them as territorial strategies designed to govern the de-subjectified flows of universal traffic. in western modernity, issues of public health have never been just about health (rosen ) . they became deeply intertwined with politics and the making of political spaces in particular. whereas the first quarantine regulations in the mediterranean city-states of the fourteenth century were famously directed at maritime trade, it was not before the seventeenth century that sanitary measures 'came to be used consciously as instruments of statecraft' (harrison : ) . on the one hand, the politics of public health influenced states' external relations deeply. to combat the epidemics of the s, england interfered with the dutch trading empire by imposing quarantines against vessels sailing from amsterdam; about a years later, austria had completed a sanitary cordon over , kilometres along the lines of a former military cordon at its eastern border (rothenberg : ) ; and in the nineteenth century, the european powers established consular commissions in alexandria or constantinople for 'defending europe from asiatic infections' (harrison : ) . on the other hand, public health had a tremendous impact on the internal politics of evolving nation states. a wide array of administrative practices, such as isolation, segregation, or urban planning, were led by the concern for health as a 'common good'an understanding that triggered regulatory reforms to set up systems of 'medical police' by the end of the eighteenth century in most european states (carroll ) . despite their extreme heterogeneity, all these instances share one common feature. in each case, the history of public health reveals itself to be tightly coupled with a history of spatio-political settings. foucault belongs among the few theorists who have explored the relation between political space and infectious diseases in a systematic manner. epidemics in particular assume a place of pride in his work. in the birth of the clinic, they are introduced as 'collective phenomena' that have 'a sort of historic individuality' (foucault : ) . epidemics appear as singular moments of crisis that provoke the development of novel spatial orders and political technologies. however, foucault is not so much interested in the historical vicissitudes as such as he uses the historical material to identify distinct rationalities. he distinguishes schematically the responses to leprosy, plague and smallpox, each of which is tied to the emergence of a peculiar cartography of power (thacker : - ) . it is worthwhile to recall shortly this reference to epidemiology in foucault's otherwise well-known genealogies of power in order to link it both to its spatial and juridical underpinnings. the government of leprosy operates through expulsion (foucault : - ) . the medieval leper is barred from the city into an outside populated by the living dead. the juridical structure of this operation is the exile that produces a life in pure abandonment. it constitutes a sovereign power based on territorial exclusion. the disciplinary response to the plague of the seventeenth century reverses this procedure. its basic formula reads: 'not rejection but inclusion.' (foucault : ) instead of drawing a single boundary delimiting an interior from an absolute exterior, discipline imposes a partitioning grid. it creates a space segmented into differentiated enclosures that seek to isolate individuals, reduce contacts and allow for panoptic surveillance. foucault describes discipline as a form of 'counter law' for it works in the interstices of liberal law, subverting freedom and equality from below through its minute normalising procedures (golder and fitzpatrick : - ) . the smallpox of the eighteenth century gave rise to yet another amalgam of political rationality and spatial order: liberal governmentality with its aim to maintain spaces of circulation (foucault : - , - ; elbe : - ; opitz ; voelkner ) . within this political rationality, epidemic disease appears as a collective affair with immanent regularities to be rendered visible by statistics. it is dealt with as a mass phenomenon through measures of public hygiene and practices of inoculation. accordingly, governmental power is not exercised over a territory but within a population. this, however, does not amount to a neglect of the individual. rather, the government of populations is linked intrinsically with the individualisation of the liberal subject (foucault : - ) . modern biopolitics addresses the health of the population through individual well-being and vice versa (foucault : - ) . governing disease within a framework of liberal governmentality has important spatial implications. the population forms a dynamic, living entity that is tied closely to the circulation of bodies, goods, and resources in space. since the circulatory flows are considered to be the well-spring of the population, liberal government aims at protecting and enhancing this metabolism in its vital force against the inherent threat of disease (swyngedouw : - ; dillon and lobo-guerrero ) . beyond this background, measures of containment and fixation through enclosures appear as inherently problematic. each parcelling of space that hinders or even immobilises those elements that are assumed to circulate is seen to constrain the life process. furthermore, since disease exists 'within a collective field' (foucault : ) it cannot be simply externalised. it is an unfortunate, but intrinsic phenomenon that cannot be made subject to a total ban. all in all, liberal government is careful not to obstruct contacts. rather, it facilitates and organises connectivities, aiming to secure them against their immanent dangers -'maximizing the good circulation by diminishing the bad' (foucault : ) . in principle, the space of circulation is therefore an open and unbounded space. liberal government operates, in foucault's own words, 'centrifugally'. 'new elements are constantly being integrated […] . security […] involves […] allowing the development of ever-wider circuits.' (foucault : ) ultimately, this centrifugal dynamic places the liberal government of circulation within a planetary horizon (mattelart : - ; lobo-guerrero ) . foucault himself devotes only a few pages to this consequence. however, this short passage that has, thus far, also received relatively little attentionis of utmost importance for the current argument, since foucault ( ) links the 'appearance of a new form of global rationality' in governmental practice with what he calls a 'juridification of the world' ( ). after gesturing towards maritime law and the problem of piracy as examples of such 'elaboration of a worldwide space' (ibid.), he turns to immanuel kant's text on 'perpetual peace' ( ). in kant, he finds the view that a global law beyond the state is to emerge from the inter-relations naturally occurring between humans all over the world. whereas political philosophers usually adopt the kantian premises for justifying the existence of cosmopolitan law, foucault turns this normative position upside down by reading kant archaeologically as a governmental script. a closer look at kant might, therefore, illuminate foucault's unusual, but innovative argument about the relation between the liberal government of global circulation and global law. kant ( : ) bases his elaborations on the 'postulate' that 'all men who can mutually affect one another must belong to some civil constitution'. in the german original, this intercourse is couched in terms of a natural 'flow' or 'in-fluence' (kant : ) that traverses the borders of state territories. it establishes a form of interrelatedness that is always already transcending the space of international law into a cosmopolitan order. kant deduces the latter from the spatial properties of the earth. because of its spherical shapeits kugelgestaltthe earth's surface forms a limited space in which human beings 'cannot disperse infinitely but must finally put up with being near one another' (kant : ) . the cosmopolitan right 'to present oneself for society' (ibid.) is thus rooted in the empirical features of global space (eberl and niesen : - ) . the earth places humans irrevocably in a proximity to one another and it generates relations of communication and exchange across the world. the means of transportsuch as ships or camels, the latter figuring in kant's ( ) view as 'ships of the desert' ( )support men in their commerce and facilitate mutual contact. they offer the technical basis for worldwide circulatory processes that follow 'naturally' from the earth's spherical shape. in this way, the cosmopolitan right is derived from those natural circulations that it has to protect. it allows individuals to get in touch with each other irrespective of their national affiliation. it stabilises the capability to connect globally, a potential that is grounded in the spatial qualities of the earth. reading kant's famous text as an instance of governmental thought fundamentally alters the role attributed to global law. from such a perspective, cosmopolitan law appears as a means to enable exchanges across the world. it secures transnational traffic and communication, thereby constituting an infrastructure for circulatory movements. in this sense, law appears as a governmental technology. again, it is worthwhile to underline the analytical twist at work here. whereas a more traditional normative reading of kant proceeds from a particular state of the world to a cosmopolitan juridical framework, the governmental reading observes how cosmopolitan law is devised as a tool to stabilise a liberal view of worldly processes. in one case, humanity's natural use of the perfectly rounded globe grounds an equally universal law. in the other case, law functions as a particular device for fostering specific modes of global movements. this difference matters strongly, since only the latter angle allows for investigating the practical work of establishing 'nomospheres'. only the second of the two viewpoints prompts empirical research to analyse how contemporary forms of global law are operative in developing governmental cartographies: how do legal textures configure movement-spaces? in which way do they specify how circulations are to be monitored, channelled and held in check in order to be maintained? how do legal regulations discriminate between what is supposed to circulate and what not? writing a full genealogy of how law becomes part and parcel of a governmental rendering of global space is beyond the scope of this article. as indicated above, the following sections concentrate on one current instance of such liberal governmentality. they excavate the spatial calculus for ensuring global health security as it is encoded in the ihr. in order to explore the intimate relationship between epidemic crisis and political space further, foucault's elaboration of governmental space serves as an analytic foil. it helps to determine the ways in which the ihr still perpetuate the rationality of liberal circulation as well as those respects in which they modify it. regulating global traffic: the post-humanism of the ihr historically, the ihr stand in continuity with the attempts at international health governance that reach back to the beginning of the nineteenth century. the system of diplomacy inaugurated at the congress of vienna ( ) constituted the framework in which the european nations began to achieve sanitary cooperation (harrison ) . the main aim was to make quarantine the object of international agreements in order to minimise impediments of commerce during a period sometimes referred to as a 'second wave of globalisation' (robertson ) . this concern led to the first international sanitary conference in . although the participants failed to agree on quarantine regulations at the first meeting in paris, ten further conferences were to follow until , most of them seeking to balance measures to prevent the spread of yellow fever and cholera against restrictions on travel, the disruption of trade and especially the costly immobilisation of ships (howard-jones : ) . in the early twentieth century, the first intergovernmental organisations grew out of the conference system: the pan-american sanitary bureau of in washington dc, the office international d'hygiène publique of in paris, and the league of nations' health organisation of in geneva. the emergence of these institutions marked the beginning of a transition from international towards global juridical structures to be continued after the second world war by the united nations and the who. according to alison bashford ( b), a particular rendering of the population question as a 'world issue' ( ) was decisive for this shift. in contrast to the national focus on matters of sexuality and reproduction, population management on a global scale was introduced primarily within an economic framework concerned with population density, spatial distribution and 'world human movement ' (ibid.: ) . 'in this way, […] 'world space' was imagined and problematized […] through 'world health', its predecessor 'international hygiene', and the problem of origin: quarantine.' (bashford b: ) against this historical background, the 'post-westphalian' contours of the ihr do not appear as an absolute novelty. according to the principles set out in article , their implementation 'shall be guided by the goal of their universal application for the protection of all people of the world from the international spread of disease'. the ihr thus follow earlier attempts at global health by situating themselves within a planetary horizon, putting forward a trans-border vision of the earth. and like earlier forms of 'germ governance' (fidler ) , which already began to exceed the demarcations of the international system about a century ago, the ihr do not simply bypass the state. they seek to realign the organisational capacities of states, integrating their institutions into a globally networked governance structure (cf. sassen ) . most importantly, the key passages of the ihr read like a clear-cut manifestation of the liberal government of circulation: 'the purpose and scope of these regulations are to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.' (ihr, article ) the mobility of disease and the mobility of goods and people are conjoined in this problem space. measures against the first should not be achieved by stifling the second. the ihr thus exhibit the liberal concern about governing too much. echoing the main gist of international trade law under the wto, they aim at circumscribing a mode of intervention that seeks to minimise potential interferences with economic circulation. if the continuity of the ihr with the basic presuppositions of liberal governmentality can be established easily, what about their specificity? what is the 'historic individuality' of the current attempt at dealing with pandemics as globally collective phenomena? to answer this question, it is necessary to understand how the ihr contain a remarkable modification of the biopolitics of liberal governmentality (lemke ) . the ihr untie the complementary relation between the individual and the population outlined in the last section. on the one hand, they almost completely remove the question of individual health care from the preoccupation with circulatory matters. this is highly significant, since during the twentieth century a right to health became implemented not only in national jurisdictions, but also in key documents of international law such as the universal declaration of human rights (article ) and the preamble to the who's constitution. yet, the ihr contain no substantial allusion to individual health, the figure of the individual person who is sick and needs care is, for the most part, absent. on the other hand, and even more curiously, the ihr also refrain from concerning themselves with the health of the population. while the figure of the population still featured prominently in the global health politics in the second half of the twentieth century, the ihr do not make a prominent reference to it. the ihr appear as an example of what niamh stephenson ( : ) or andrew lakoff ( ) have observed as a more general political trend: that the population ceases, increasingly, to be the main object of public health. although not being completely absent, it appears only marginally in the ihr. this raises the question of what has come to substitute the dual structure of the individual body and the population in public health: what is put at risk by epidemic disease? within the ihr, the concern for global circulation is expressed mostly with regard to the spatialities of global traffic. the ihr demand special attention for those 'public health risks existing in areas in which the international traffic originates, or through which it passes' (ihr, article . ). they specify 'core capacity requirements for designated airports, ports and ground crossings' (ihr, annex .b). and they include specific standard forms for controlling ship sanitation (ihr, annex ) as well as a model of a maritime declaration of health (ihr, annex ). in this way, traffic designates the particular kind of movement that is both a risk and at risk. pathogens circulate through global traffic, and the control of the spread of disease may, therefore, lead to interferences or even interruptions that are to be avoided. this problematisation resonates with accounts of emerging infectious disease (eid) that became influential at the end of the twentieth century (lakoff : - ) . most notably, the epidemiologist and virologist stephen s. morse has described topologies of contagion in terms of 'viral traffic ' ( ) and 'global microbial traffic ' ( ) . since viral trafficbroadly defined as 'movements of viruses to new species or new individuals' (morse : )is always bound up with patterns of human traffic, morse calls for 'viral traffic planning' (ibid.: ): 'basically, people are creating much […] of the traffic […] . we need to recognise this and learn how to be better "traffic engineers".' (morse (morse : especially ecological changes in land use and demographic changes in population density produce a new quality of biosocial interrelatedness: 'no one is truly isolated and therefore impervious to microbial traffic.' (ibid.: ) as to the ihr, the who seems to share this vision of global transportability: traffic appears as an almost universal frame for planetary circulation. microbial traffic is intertwined firmly with the world traffic in trade and travel, since the latter constitutes a vehicle for the former. in turn, the ihr circumscribe a liberal regime of para-medical policing. they do not concentrate on healing bodies, but rather on regulating free movement. within the spatial logic of governing global microbial traffic, processes of transmission are of key concern. this focus displaces the medical concern for individual symptoms of disease. the individual symptom becomes only relevant in so far as it may refer to potential 'routes of transmission' (ihr, annex ). whereas the symptom is a hermeneutical concept, based on the idea of interpreting signs of illness, transmission is a media concept with a postal structure that is both spatial and operative (krämer : - , - ) . in its simplest form, transmission involves a carrier that transfers a pathogen from one point to another (wald : - ) . the ihr present a broad inventory of physical bodies that may act as potential carriers, covering the whole spectrum of humans, animals and inanimate matter. disinfection, for example, is defined as the 'procedure whereby health measures are taken to control or kill infectious agents on a human or animal body surface or in or on baggage, cargo, containers, conveyances, goods and postal parcel' (article ). everything that circulates can function as a carrier of transmission: faeces, food, water are mentioned in the same manner as human remains (ihr, articles . and . ). if anything, not the human, but animals feature as crucial carriers of transmission. especially insects are seen as 'vectors' of epidemics, since they 'transport an infectious agent that constitutes a public health risk' (ihr, article ). these bodies of transmission belong to a governmental vision that pictures the world as a space of universal traffic and that focuses on routes and material means of global circulation. in order to grasp the peculiarity of this governmental view, it may be instructive to recall that issues of public health have been traditionally tied to what robert castel calls 'the social question'. according to castel ( ) , the social question highlights the way in which a society 'experiences the enigma of its own cohesion' and the 'dangers of disintegration' (xix-xx). the social question problematises the capacity 'to exist as a collectivity linked by relations of interdependency' (ibid.: xx). reading the ihr, one might say that, the social question becomes less social and more transactional. the globe is imagined as a transactional sphere in which relations of interdependency are established through modes of transportation that involve organic and inorganic matters. while the danger of disintegration remains related to the threat of an international health emergency, the referent of this threat takes on a novel form. as outlined above, the threatened object is neither the body of the individual nor the collective body of a population. it is instead the very global movement of animate and inanimate entities across boundaries, which has to be protected against immanent threats. the management of public health risks is therefore concerned primarily with what collier and lakoff ( ) have identified as 'vital systems'. it is attentive to those infrastructures, hubs and nodal points that 'operate' world traffic and realise global connectivities . within this framework, the individual tends to be seen, at least in principle, only as one risky body among others. it appears as one potential carrier, moving along routes of transmission together with other potential carriers. global health has thus turned into a thoroughly post-humanist affair. in an uncanny resonance with the vocabulary of current social theory, the ihr focus on the 'vibrant matters' (jane bennett) and 'insect media' (jussi parikka) that are vectors of transmission. what actually matters are the multiple connections established by all kinds of substances in motion, no matter if they are fluid or solid, organic or inorganic, animate or inanimate (clark ) . taking into account the 'ecologies of pathogenicity' (collier and lakoff : ) , the ihr extend the concept of global public health to all the materialities involved in the planetary movements that they seek to secure. in conjunction with a shifting problematisation of the governmental object towards the 'vital systems' of post-humanist traffic, the technologies of control become recalibrated. while the liberal maxim of 'laissez faire, laissez passer' can still be seen to capture the professed aims of the ihr, it does not tell about the territorial technologies that mark out its nomosphere. in fact, the current preoccupation with circulatory processes in the field of global health security does not amount to a 'de-territorialized smooth space' of 'uncoded flows' (deleuze and guattari : - ) . rather, letting the planetary traffic pass securely involves accompanying spatial measures that control the passage of subjects and objects within 'molecular geographies' (braun : ) . accordingly, the ihr formulate a set of 'recommendations with respect to persons, baggage, cargo, containers, goods and postal parcels' (ihr, article ). two of them in particular are designed for managing the risk of disease transmission: screening and quarantine. as will be elaborated in the following, both screening and quarantine implement spatial thresholds of 'social sorting' (bowker and star ) at which carriers of disease can be singled out. they form peculiar strategies of division and enclosure that rely on classifications of risky bodies. as such, they supplement the government of global circulation. they re-territorialise the flow of subjects and objects and, at the same time, correspond with the governmental post-humanism just elaborated. the year before the adoption of the ihr, the un high-level panel on threats, challenges and change expressed great concern about the epidemiological vulnerabilities generated by civilian air traffic: 'any one of million international airline passengers every year can be an unwitting global disease carrier' (un : ) . in order to control this potential for pathogen transport, airports in hong kong, china or singapore had already installed cameras for infrared thermal screening during the sars outbreak (ong ) . these apparatuses hold the promise of visualising threats within circulatory flux. they aim at the identification of sick bodies by scanning the temperature of travellers for fever in a supposedly non-invasive manner. actually, the attempt to use infrared thermography to govern disease involves a range of problems. leaving aside the flaws in camera instalment, the true body core temperature always differs from the cutaneous temperature, the latter depending on the body parts selected for measurement or the outdoor temperature; moreover, persons may also be infectious without developing any increase in body temperature (mercer and ring ; nishiura and kamiya ) . nonetheless, the absence of thermal screening devices at canadian airports has, apparently, been a decisive factor, when the who issued a travel advisory for toronto and other affected areas during the sars outbreak ( van wagner : . since , the ihr authorise the who to 'recommend' the application of mass screening devices in case of a 'public-health emergency of international concern' (ihr, article ). when the who declared the influenza a h n (the 'swine flu') virus a pandemic in , entry and exit thermal screening measures were adopted at airports worldwide. the spatial logic enshrined in technologies of thermal screening corresponds with the main goal laid out in the ihr: providing security against epidemic disease while reducing the interferences with traffic and trade to a minimum. as a checkpoint technology, thermal screening controls bodies in passing. it fits the liberal imaginary of flows running through space (sutherland ) . airport architectures, form choreographies of pathways and lanes that order the movement of travellers (adey ) . metaphorically speaking, they create canals and conduits for traffic flows into which checkpoints are interpolated. through thermal screening devices, the governmental function of securing global circulation gets embedded in the nodes of transportation networks. however, as a checkpoint technology, thermal screening also differs from traditional forms of border control. to begin with, thermal screening operates beyond the hermeneutics of confession (salter : - ) . it does not want to know what the traveller has just bought or how long she will stay at her destination; the apparatus for temperature detection is neither interested in intentions nor does it test the narratives for credibility. it circumvents the moment of interrogation in its desire to 'know the fleshy body' (amoore and hall : ) as it moves within world traffic. if one were to speak about confession at all, thermal screening does not elicit confessions of the flesh but 'confessions by the flesh' (adey : ) . amoore and hall ( ) have recently described the use of backscatter x-ray devices at airports in terms of 'somatic probing […] at the border' ( ), and this characterisation clearly applies to the practice of thermal screening as well. at the same time, and in contrast to passports or biometric control, thermal screening does not seek to authenticate a person. instead of verifying a social identity, it addresses the body simply as a physical object (schillmeier : ) . by focussing on the bareness of biological life, the social person reverts to an organic entity. social markers such as gender, religion or nationality do not matter for deciding if someone is eligible to move on or not. of course, those forms of border control that operate through interrogation and authentication do not disappear. rather, thermal screening works in tandem with them, enhancing the regime of 'vigilant visualities' (amoore ) at the border through its medical design. screening technologies allow for modes of classificatory sorting. as such, they generate causes for further action. they serve the strategic goal of identifying sick bodies that may be isolated subsequently. the ihr define isolation as the 'separation of ill or contaminated persons or affected baggage, containers, conveyances, goods or postal parcels' (ihr, article ). quarantine differs from isolation by its specific preventive stance: it aims at 'the separation from others of suspect persons who are not ill or of suspect baggage, containers, conveyances or goods in such a manner as to prevent the possible spread of infections or contamination.' (ihr, article , author's own emphasis) as such, quarantine uses the spatial measure of separation to insert a delay into the movements of indeterminate bodies. this practice follows, in principle, its historical predecessors (gensini et al. ). in , the rector of the seaport of ragusa issued the trentina: ships originating from areas with plague had to stay at anchor for days before disembarking. this period was soon to be extended to days, which explains the etymological roots of quarantine. even though originally quarantine had been introduced as an alternative to simply deterring ships from landing, it was soon to be regarded as deleterious to commerce and travel. as outlined above, the international sanitary conferences from the nineteenth century were motivated by the aim of regulating quarantine in europe. yet, in , when the who implemented the original version of the ihr, the term 'quarantining diseases' disappeared. at that time, public health experts began diagnosing an 'epidemiological transition' that would eliminate the need for border quarantine with infectious disease altogether (cf. king : ; hinchliffe et al. : ) . but during the sars crisis, quarantine had its great global revival before it reentered the new ihr (cetron et al. ) . in hong kong, the authorities quarantined large parts of the amoy gardens apartments; in toronto, up to , people have been subjected to temporary arrest ( van wagner : . in parallel with the implementation of the ihr, national jurisdictions amended existing quarantine laws or issued new ones. until today, most international airports have established quarantine stations, the coordination of quarantine with screening procedures being one main issue in pandemic preparedness planning (gaber et al. ). additionally, the un ( ) has attributed the responsibility for quarantine to the security council, turning quarantine into a matter of world politics: in 'the event that a state is unable to adequately quarantine large numbers of potential carriers, the security council should be prepared to support international action to assist in cordon operations. ' ( ) in the social imaginary of quarantine, the spatial aspect of enclosure prevails. quarantine is associated with the fixation of bodies in an inner outside. yet, in order to understand quarantine's role in the government of global circulation envisioned by the ihr, one has to consider how quarantine conjoins the spatial measure of containment with a temporal calculus. quarantine reckons with the temporal lag that exists between infection and the visibility of symptoms. it operates on the indeterminacy of the body during the incubation period, that is, its potential for being a vector of contagion. quarantine is, therefore, not so much about predicting what a body can become (dillon : ) , but simply about waiting for a determinable status to emerge. if biosecurity 'today names a set of political responses within globalisation that take the unpredictability of molecular life […] as their justification' (braun : ) , then quarantine constitutes a biosecurity technology that seeks to control the dynamism inherent in life bingham : ) by containing mobile bodies. it takes bodies out of circulation temporarily and puts them at a distance to other bodies in order to see if they are actually contagious entities or not. but how can one identify the risky body that shows no symptoms at all? the ihr give a hint about how to answer this question by referring to the 'tracing of contacts of suspected or affected persons' (ihr, article ). it was again within the governmental laboratory of the sars crisis that decisions over quarantine were relegated to 'contact tracing centres'. as a study of the procedure established by the singapore ministry of health in details, the 'components of contact tracing included the following: obtaining all patient movements during the symptomatic stage; identifying the persons who had contact with the patient during these movements; and instituting follow-up action on the contacts for a -day period.' (ooi et al. : ) starting from a map of movements, contact lists were to be created and a quarantine board had to decide on the basis of these lists about whom to quarantine. according to this procedure, physical contact generates 'suspicion'. it turns a person into a 'suspect person', baggage into 'suspect baggage', or containers into 'suspect containers' (ihr, article ). quarantine thus implies a thoroughly postliberal concept of suspicion based on spatial proximity. instead of referring to a voluntarily committed deed, the suspicion relates to a potential bodily state derived from physical contacts. quarantine, in response, seeks to 'reduce transmission by increasing the "social distance" ' (cetron et al. : ) . in this governmental logic, the attribute of the 'social' has become tantamount to nothing more than material connections. quarantine, is applied to potential carriers of contagious disease who have been in contact with actual carriers and whose potential for establishing connections with other bodies shall be interrupted. it provides for moments of disconnectivity by means of spatial separation until bodies can, again, be securely released into circulation. both quarantine and thermal screening are central elements that mark out the nomosphere of global health. they are technologies of governing which entail a re-territorialisation of planetary circulation (bach ; opitz and tellmann ) . according to the famous definition put forward by the human geographer robert d. sack ( : - ) , territorial practices control relationships by configuring different degrees of access to people and things. hence, territorial practices cannot be reduced to the historically specific mode of territorialisation at work in the formation of modern state territories. instead, territorial practices have to be conceived of in a broader sense: by 'carving the environment through boundary-drawing activities' (brighenti a: ) , they 'enable the production of functions, the management of distances and the setting of thresholds between events' (brighenti b: ) . this operative control of spatio-temporal relationships and accessibilities lies at the very core of both quarantine and screening. as territorial practices designed to administer circulatory movements, they do not establish habitats, but mobilitats. despite their differences, screening and quarantine share two territorial functions. first, within the contemporary context of the 'new virologies of globalisation' (galloway and thacker : ) , they introduce practices of division into circulation. both technologies implement mechanisms for identifying risky bodies, and they do so for the purpose of differentiating the safe against the potentially dangerous elements. since these modes of classificatory sorting distinguish bodies that can pass from those that cannot, one might portray them in terms of territorial exclusion. however, it is important to note that they do not seek to secure a territory against threats coming from outside. rather, according to the rationality of the ihr, they intend to moderate circulatory flows in their immanence. the notion of 'differential inclusion' (mezzadra and neilson : ) , therefore, seems preferable for characterising the role screening and quarantine play in the current regime of global health security. it avoids the idea of an outside in favour of picturing a continuum of discriminating thresholds. furthermore, both screening and quarantine configure different degrees of mobility and immobility (salter ) . borrowing from lefebvre ( ) , they can be qualified as rhythmtechnologies: by producing flexible boundaries and temporal halts within circulatory processes, they structure the velocity of movements and the intervals of connectivities. measures such as quarantine and screening thus deploy spatial means for temporal ends. they act on infection rates in order to slow down or delay the spread of disease (cf. schlaich et al. ) . such efforts at manipulating circulation take into account both social and biological rhythms. in fact, the latter distinction loses its significance in favour of those material relations that produce frequencies of connectivity. each body may be a point of contact and contagion is the prime mechanism to be reckoned with. in a thick description of the emergency government during the sars outbreak, wang min'an ( ) has noted that sociological models have failed to make sense of this situation: 'what is needed is an antisociological account, an antisignifying account […] .' ( ) min'an has observed a decreased impact of symbols and meanings as soon as the bare physicality of bodies in divided spaces takes precedence. 'in general, then, only two types of bodies exist: virus-carrying bodies and non-virus-carrying-bodies.' (ibid.) this corpo-realism that is born out of a situation of emergency seems to have captured the imaginary of global health governance. the technologies of screening and quarantine correspond with the ihr's overall concern for the materialities of human and non-human traffic. while thermal screening addresses organic life in its physical properties, quarantine seeks to control any entityanimals, humans, conveyances or even buildingsthat has been exposed to a contagious agent. as territorial strategies, they modulate the capacities of bodies to connect both by configuring their distance and their rhythm. the findings presented in this article may inform the wider theoretical debate about how to conceive of contemporary political spaces. within the last decade, spatial theorists have, to a large extent, relied on a binary matrix that opposes absolute to relational spaces, topographies to topologies, and territories to networks (amin et al. : ) . in order to evade the 'territorial trap' so famously identified by john agnew ( ) , one had to side conceptually with the relational topologies of networks, privileging the fluid over the fixed. only recently inverse warnings about a 'nonterritorial trap' (jones : ) have re-emerged together with the efforts to integrate the different registers. the analysis presented here offers a contribution to this problematic. the nomosphere of global health security delineates a 'movementspace' (thrift ) composed of mobile bodies that act as relational transmission media. potential patterns of contagion emerge from the patterns of world traffic. on the one hand, this amounts to a 'topological landscape of embeddings and disembeddings' (hinchliffe et al. : ) in which relations are conceived of in terms of intensities. topographic distances matter less than the potential of a body to affect other bodies. at the same time, however, the extensive properties of relations remain salient. the bodily potential to affect and be affected is intertwined with topographical processes of diffusion and dissemination. distances matter strongly. yet, rather than being seen as fixed, they are conceived of as highly malleable. territorial strategies seek to re-configure distances along with permeabilities, velocities and rhythms. the nomospheric investigation of global health security thus helps us understand how territorial strategies become imbricated in global topologies. instead of opposing the territorial and the topological, it prompts the sociology of political space to think of territorial practices topologically. but how does such topological territoriality challenge the national political territory as the basic unit of the modern international order? this article started with the suggestion that the diagnosis of sars being the 'first post-westphalian pathogen' belongs to a particular problematisation of governmental space. as jean-françois lyotard ( : - ) has pointed out memorably, the suffix 'post' does not claim an absolute caesura. it much more indicates a transformation that remains indebted and tied to that which it transcends. accordingly, this article has not presented a diagnosis about a neat transition from international politics to world politics (walker ) . in a way, one just has to look at the cartographic lines on world maps in order to register the persistence of the modern state form. accordingly, the ihr do not simply bypass the state. they rather mobilise intergovernmental institutional backup for realigning the organisational capacities of states, thereby assembling a globally networked governance structure designed to control circulatory processes that harbour the potential for universal viral traffic. however, the ihr do so by changing and challenging the function of territoriality. within the framework of the modern nomos of the earth, law and territory were coupled to achieve both ordnung (order) and ortung (location) for a defined political nation. this coupling seems to dissolve as soon as globalisation can be equated with 'global mobilisation' (galli : ) . the ihr as a global juridical document establish a different conjunction between law and territory: territory turns primarily into an ordering mechanism for bodies in movement. the nomos of global circulation enshrined in the ihr, therefore, resembles what legal theorist cornelia vismann ( : ) , in a different context, has termed a 'nomadic nomos'. seen from the modernist angle, a nomadic nomos can certainly only be perceived as a paradox: a nomos without the localisation of order. nonetheless, nomodicity might in fact be the political-juridical signature of the global age, in which 'global space forms itself through a universal immediacy of mediations' (galli : ) . but what happens to the political qualities formerly associated with the act of ortung? the juridical-political laboratory of epidemic communicability simultaneously contains and hides how contemporary political collectivity is 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genealogy of global health security about the author he teaches social theory with a focus on the linkages between systems theory and poststructuralist approaches. his research addresses the temporal, spatial and material aspects of security and law. he is currently working on modes of global contagion and control. recent publications include an der grenze des rechts: inklusion/ exklusion im zeichen der sicherheit (velbrück, ) and 'future emergencies: temporal politics in law and economy key: cord- - fz e k authors: henríquez, josefa; almorox, eduardo gonzalo; garcia-goñi, manuel; paolucci, francesco title: the first months of the covid- pandemic in spain date: - - journal: health policy technol doi: . /j.hlpt. . . sha: doc_id: cord_uid: fz e k background: : the covid- outbreak has led to an unprecedented crisis in spain. after italy, the spread of the virus was quick, and spain became the second epicenter in europe by number of cases and deceased. to tackle the outbreak and contain the spread, the spanish authorities undertook exceptional measures based on a generalized lockdown by which the majority of the economic activity ceased for several weeks. objectives: : the goal of this paper is to examine the spread of covid- in spain from february to may , as well as the public policies and technologies used to contain the evolution of the pandemic. in particular it aims to assess the effectivity of the policies applied within the different autonomous communities. cases and deaths are presented until august as well as the main changes in containment and mitigation measures. methods: : data was collected from various official sources, including government reports, press releases and datasets provided by national and international level institutions. results: : we show that the main measure to contain the spread of the pandemic was a stringent confinement policy enforced through fines. it resulted in a substantial reduction in the mobility and the economic activity. at a regional level, the negative consequences of the crisis affected differently across regions. the covid- outbreak has led to an unprecedented crisis in spain. after italy, the spread of the virus was quick, and spain became the second epicenter in europe by number of cases and deceased. although the first case diagnosed with covid- was registered at the end of january, the spanish health authorities did not undertake measures until one month later, moment when a systematic and exponential increase in registered cases and deceases was observed. to tackle with the outbreak and contain the spread, the management of public health policies were centralized within the ministry of health and the authorities undertook exceptional measures based on a generalized lockdown by which the majority of the economic activity ceased for several weeks. in this paper we describe and analyze the spread of covid- in spain and the policies and technologies used through the course of the unfolding of the pandemic. our focus consists of assessing the patterns within regions departments, autonomous communities (ac), to understand how the pandemic evolved across different parts of the country. this question is particularly relevant for the spanish case given the highly decentralized nature of the health system where ac manage most public health policies and are provided with different health resources. these different resource allocations across ac prior to the crisis could have been key determinants to understand the spread and impact of the virus throughout different parts of the country. we do so by exploiting official sources of epidemiological information and assessing the trends across ac. in particular, we study several indicators that include: registered cases, recovered, deceased, hospitalizations, icu cases by age and gender and comorbidity patterns. further, we pay special attention to the outcomes of the different policies and technologies. in particular, we evaluate the effectiveness of lockdown measures by comparing the evolution of a stringency index during the different stages of the pandemic and mobility. the rest of the paper is structured as follows. section provides an overview of spain and its health care system. section describes the main epidemiological trends. section presents the series of policies put in place. section outlines the health system response. section shows some economic and financial spillovers of the virus. section concludes. at the end of the document the references can be found. in , spain's population was million people, distributed among the acs that further divide into provinces. the health system is organized via a national health system typology, "sistema nacional de salud" (in spanish), and provides universal healthcare through , primary care facilities of general practitioners (gp), and hospitals ( ) . acs are the main managers of the health system coordinating the provider networks and purchasing resources. further, the ministry of health, dependent on central government, mainly acts in stewardship and coordination with the ac through the interterritorial council of the national health service. table contains an overview of the demographics and health system characteristics of spain, which we use as aid in contextualizing the epidemiological trends of covid- and changes in health resources. spain's life expectancy ( . ) is the highest amongst in the european countries and it is well above the average of oecd nations ( . ). as an ageing country, the share of population over exceeds other oecd countries ( . vs . ) as well as the old age dependency ratio ( . vs . ). alongside this longevity, spain presents a significant rate of morbidity having a . % of older than with two or more chronic conditions and a . % of diabetes prevalence (also higher than the . average in oecd countries). [insert table here] in a universal system, free at the point of use , the funding of the health system plays a key role. as a result of the financial crisis, over the period - the health budget shrank ( ) . these reductions resulted in decreases from . % to . % of the average participation in funding of the portion related to government compulsory schemes. at the same time, private expenditure on health, especially out of pocket spending rose, reaching . % currently. the existing proportion of health expenditure as a fraction of the gdp ( . %) is around oecd numbers ( . %), and higher than in ( . %), while per capita healthcare expenditure of , usd (ppp) in , was below the oecd average of , . in terms of health and long-term care resources such as doctors, nurses and beds per , population, spain falls above oecd levelsespecially regarding nurses and hospital beds. concerning long term care resources, despite not ranking among the top countries, spain has more beds in long term care residences than italy ( . ), and falls slightly above oecd average ( . ). ratio between those in working age with respect to those and above there are some exceptions such as pharmaceuticals. table shows the differences in health resources across the acs. andalucía is the biggest ac by population whilst the autonomous city of melilla presents the highest population density. other big acs by population are madrid and cataluña. cataluña, is also on top regarding number of hospitals and beds but not in the number icu beds, key to treat covid- severe patients, or primary care facilities important for tracking early cases. [insert table here] the covid- outbreak has modified the existing decentralized organization of health system. since the declaration of the state of alarm ( th of march), the main tasks and policies to tackle the crisis were temporarily centralized around the ministry of health. these included centralized purchase of necessary goods and services in order to meet three main purposes (according to the ministry): reinforcement of the ac purchasing processes, allocation of resources among the population and professionals and organization of the production at national and international level. only once the outbreak is under control its effects and the state of alarm will conclude ( st of june). this implies that the acs, at different speeds, will be regaining their competences in health. the ministry of health is the authority that sets and manages the protocol for reporting information related to covid- . using a notification form, the ac report to two bodies under the ministry of health: the national center of epidemiology (centro nacional de epidemiologia, cne) and the center for coordination of alerts and sanitary emergencies (centro de coordinación de alertas y emergencias sanitarias, ccae). another key institution, in charge of the management and release of the epidemiological information is the charles iii institute of health (instituto de salud carlos iii, isciii). the isciii, gathers the information through the national network of epidemiological surveillance (renave). the isciii is the official source of information and we will use it in the paper. until may, the isciii released daily information at regional level regarding confirmed cases (through different testing methods), hospitalizations as well as referrals to intensive care units (icu), deceased and recovered cases. since then, and currently, daily data only on daily cases is being released, and is available to download in an interactive website ( ) . further the isciii elaborates reports with relevant breakdowns of the information (i.e. demographic, clinical and epidemiological risk history characteristics). two main caveats in the data must be mentioned. first, in the initial stages of the pandemic, there was misalignment in the criteria applied by acs to classify new and hospitalized cases. since the th of april, a unified criterion was implemented to account for the number of confirmed cases. these criteria included positive cases under different testing methods (e.g. pcr and antibodies tests) ( ). second, data since the th of may is under review, and since then the same information as before hasn't been released. for this reason, we use information until may to capture the complete range of epidemiological indicators, while we update the data until august, capturing daily cases (the currently available information). there are other types of information available that are relevant for the purposes of this paper. in particular, information on existing health resources, reported by the ministry of health and information on new measures to mitigate the contagion. the first confirmed case of covid- in spain was reported on the st of january. it was an imported case corresponding to a german tourist visiting the island of la gomera (canary islands). after a month the number of confirmed cases increased to . [insert figure here] seroprevalence study ( ) detected initially that around % of the spanish population had antibodies, with a variability among regions and provinces ranging from . % to %. this would mean that around . million individuals got the virus, while official numbers (subject to underestimations due to testing criteria and the nature of the illness where people can be asymptomatic, among others) are around , . figure presents several snapshots of the fatality rates during the outbreak at province level. these data are released independently by different regional governments and collected by montera . the data used for the calculation of fatality rates are also affected by the change in the methodology mentioned above so are updated to the last record available before the change in the methodology. during the first half of april fatality rates reached their peak affecting several provinces located in the east of the country. a month after the worse parts belonged to provinces from ac of cataluña, extremadura, asturias, castilla-leon and madrid. indeed, deaths in the peak of the pandemic have been proved to be significantly above (around twice) the reported by the ministry of health compared to deaths registered in the daily mortality monitoring system ( ) and those informed by the national institute of statistics ( ), compared to the same dates in the previous year. [insert figure here] the cases of hospitalisations and referrals to intense care units (icu) have spread differently between different age ranges. as shown by figures and , the most affected groups have been individuals older than years old which have been classified as risky population. in addition, especially in patients within the former age range, there has been a significant gender gap in hospitalisations where men have shown higher number of hospitalisations and icu referrals. interestingly the trends remain in parallel between genders for individuals younger than years old. the epidemiologic information concerning diseases that may be related to covid- is presented at aggregate level without differentiation between acs in figure . despite registering a lower number of hospitalisations, women registered a higher of daily cases than men in several diseases that included cardiovascular, diabetes and respiratory. yet, trends across genders are fairly similar. amongst all diseases, the base disease and associated risk is the comorbidity that presents more registered cases. [insert figure here] to address the spread of the virus, typically countries will put in place measures to contain and mitigate the spread and also, due to the consequences those policies on the economy. as the peak of the pandemic has passed, it is necessary to cover two parts of the policies, their phase in, and their phase out. after who's notification of the existence of covid- , spain was quick to follow the advised instructions of the international organism in terms of epidemiological protocols and spread of information to the public. press releases showed a confident approach by the authorities but also, a non-alarming one. an example is a press note from the rd of january arguing for reduced risk as spain had no close links to the epicenter in china (wuhan had no directs flights to from spain, or china not being a frequented vacation destination). figure describes the full timeline of policies implemented to contain the spread of the virus. until the middle of february, only minor measures where implemented, and at the end of the month, the government opted to inform those with symptoms to stay home ( - ). some regional restriction where put in place after. since then, activities, gathering, sporting events started their suspension. the th of march, schools and universities were closed when community outbreak was declared, following the th of march, a flight ban to italy was imposed. it was only on the th of march, when , cases had been recorded and reported deaths, spain declared the state of alarm, limiting all people movement, with exception of grocery shopping, pharmacy and others. this came nearly a week after italy imposed a nationwide lockdown (the th of march), but at a comparable number of cases ( , ) , and around times less deaths ( ). despite this, cases continued an upward trend, and tightening of the lockdown was issued on the th of march, where all non-essential activities where stopped. [insert figure here] to assess the efficacy of the measures, figure shows the containment measure stringency index ( ) , which captures eight policy indicators on containment and closure policies (e.g. school closures and restrictions in movement) compared to the daily new cases (until august). it is observed how the measures started to grow in terms of containment while the pandemic was unraveling and stayed at their maximum from the start of april. in consequence, cases declined, and have remained low for may and june. it has become evident that after the spanish bumpy start, the restrictive measures that moved fast into extreme draconian ones paid the dividends. [insert figure here] several determinants can be related to the success of the measures, aside the broadness of the containment measures. two other key ones relate to the enforcement of the measure and their outcomes (e.g. mobility). regarding the first, the state of alarm allowed punishable measures to be imposed, with fines ranging between € and up to € , . the ministry of internal affairs ( th of april) informed that , fines had been issued since ( ) . moreover, as in other countries, drones have been operated by police forces to monitor the measures imposed (e.g. lockdown) and to inform individuals out in public about hygiene measures. this further reflects on the mobility of the spanish population. figure plots the percentage of mobility of the population per ac respect to the reference period - february. it can be observed how mobility was significantly reduced during the first week of the state of alarm, and was kept low during the lockdown period. [insert figure here] regional effects of the lockdown have been highlighted in amuedo-dorantes and co-authors ( ) , which show that regions that where at early stages of the contagion and were affected early on by confinement measures, reduced mortality rates. on the same basis, orea and Álvarez ( )) using a spatial econometric approach simulate different scenarios to assess the effectiveness of the lockdown measures. their results suggest that the lockdown reduced the covid- cases in about % especially in provinces close to the outbreaks. also, they conclude that the effectiveness of the lockdown could have improved by . % if the measures would have been implemented a week before. the reduced number in daily cases among others implied that gradually the country phased out the restrictions (see figure ). as of monday, th of april, working restrictions to non-essential workers were lifted, and thousands ( ) of workers returned to work, while citizens were still obliged to stay home until the th of april. two further policies were put in place: first, allowing minors (younger than ) to go outside, and second, in different timeslots, for those years and older to exercise outside. [insert figure here] the government has since agreed on a "plan of return to the new normality". different to how the state of alarm happened, applicable for the whole of spain, this plan will occur per ac in a process of co-governance with the ministry of health. some criteria have been put out by the ministry of health, but also, due to the fact that the government is in minority, political pressures from the ac will play an important role. when measures started to be consistently at lower levels, cases have started to slowly go up, and have now increased quite significantly to levels of april. moreover, mobility has increased substantially, and currently, probably due to the summer period, it is higher than in the reference period. this correlates too with the increases in cases observed. shutting down the economy, has meant that the government, to reduce the catastrophic impacts in businesses and individuals in terms of finances, have implemented several policies to push money into the country. legally, this have been published through several royal decrees. figure shows the timeline of the four main decrees that aimed at addressing the economic impact of covid- , and the two main restrictions imposed: declaration of the state of alarm and the closure of non-essential activities. [insert figure the decree / expanded measures related to an unemployment figure, temporary employment regulation known as erte, to protect employment, ranging from an extension of this figure due to major circumstances, and allowing those with erte to not contribute to social security. additionally, and not strictly related to covid- but highly influenced, was the implementation of the minimum vital income. the royal decree / , aimed at reactivating employment, protecting autonomous work and the competitiveness of the industrial sector. to address the needs associated to covid- , spain had to unravel an extraordinary response in regard to its health system, putting to the forefront technology interventions. the pandemic, has also had spillover effects on non-covid related health care and health problems which are necessary to address to comprehend the full picture of the efforts and impacts. initially, spain was not equipped to deal with the rapid surge in cases. as mentioned, not only the organization of the system (e.g. decentralized), had to be modified, but the delivery of care (e.g. telemedicine), and its capacity had to be increased significantly in all major areas. this ranged from testing (availability of pcr and rapid tests, as well as labs to analyze them), beds (in existing and new facilities, and of different levels of severitygeneral ward and icu), ventilators, medical staff to personal protective equipment (ppe). two main changes with respect to the delivery of care occurred: a move towards telemedicine, and the use of phoneapps to provide information about the illness. first, several private initiatives towards telemedicine, in the form of apps and in supplementary insurance plans added this type of consults and experienced a growth of their use ( ) . public use of telemedicine has been locally promoted, for example, the "hazlo" project, for the cardiac rehabilitation unit of the ramón and cajal university hospital (isciii and ramon y cajal university hospital) is a good example, while other types of consultations in the public system have been done through phone calls. second, the severity of the spread required information and services to alleviate calls to emergency rooms. phone apps where a key tool to provide information, self-diagnostic and monitoring of symptoms (e.g. apps like "stopcovid " in cataluña, "coronamadrid app" for madrid or "asistencia covid- " in canarias, cantabria, castilla-la mancha, extremadura, and asturias). in the pais vasco, "covid .eus", aimed additionally at prevention, follow up to possible cases in their homes, and analysis of the concentration of cases. capacity of the system was quickly upscaled. one area of specific importance was testing. as the emergency unraveled, to contain the spread testing had to be increased and testing criteria evolved. testing widely has become the cornerstone of the health policy specially, to be able to lift restrictions. to achieve that objective, the country has increased labs available and processing capacity and purchased significant amount of materials. a key actor in this regards, dependent on the ministry of health, is the national center of microbiology (centro nacional de microbiología), which has assessed testing facilities and performed testing analysis. a key component has been the use of technology. specifically, the use of robots (currently, ) in different institutions to automatize testing. this has been paired with the purchase of swabs (pcrs) and antibodies tests that have been distributed. table shows the testing criteria. in can be observed that a reduction of the initial restrictions in place occurred over time. [insert table ( ) . this has set the processing capacity around , daily pcr tests. since reporting started, on the th of april, the median days from symptoms to diagnostics was days ( - range), while on the report of the th of july, this number had been reduced to ( - ). nevertheless, the regions vary in their testing agility, as outlier is melilla, with days, and a range of - , until the th of july, while this value dropped to on the th of august ( ). news on the mentioned date with respect to tracing, the task has been given to the acs and a protocol has been elaborated by the ministry of health on that regards. as the regions have the autonomy to decide their tracing strategy, there is variation in the way they do so. a notable case that has been criticized is madrid, that hired a private company to do the tracing ( ) . tracing, as of the first report ( th july), managed to reach ( - ) close contact. until the th of august, the mean number of close contacts traced was ( - ). again, there is variance between the regions, as the highest median number of contacts identified per case in canarias is , while the lowest is castilla la mancha with provisional hospitals had to be opened. notable cases are ifema (feria de madrid) ( st march) that could have accommodated, if necessary, up to , beds (and up to icu beds) although it had a maximum of about , simultaneous patients; and in catalonia, fira de barcelona, which opened ready to admit patients although potentially they could have been increased to , . before the th of march, icu beds totaled , ( ). as observed in table , where the new icu and total beds are presented, an increase of % has been experienced to a total of , as of march th . despite some of the ac, previous to the virus, having the highest regional number of icu beds (e.g. madrid, ), the sharp increase in cases saturated the capacity. the ac that increased in the greatest percentage its icu capacity was país vasco ( . %), followed by murcia ( . %), and madrid and catalonia ( % and . %, respectively). [insert table here] a key resource to treat serious patients are ventilators (invasive and non-invasive types). there is no data regarding pre-covid- availability of ventilators to offer relevant comparisons. nevertheless, since data has been made public ( th [insert figure here] in an effort to increase work safety, the country had to significantly increase the delivery of ppe to the acs. by means of centralized purchasing, and a public formula for distribution based on population size and epidemiological data, the ac receive masks (see figure for the distribution over time compared to ), being madrid (more than . million) and catalonia (more than million) the cas receiving the highest amount. as of th of may, a new system was implemented combining the petition of the acs and the ministries calculation to meet a "reservoir amount" of masks. we must note that this does not consider the material purchased individually by each ac. to deal with the human resource shortages that covid- infection of medical staff and the general spread of the virus put in the system, a series of conditions previously in place related to contracting of medical staff, retirement, resident doctors, and graduation of health professionals had to be relaxed. the ministry of health informed that to the nd of april, it had increased the available for-hire health professionals to an extra , . the second group of measures has consisted of cross-regional hiring process of health professionals from regions with less demand of covid cases to regions with higher levels of demand as for example madrid or catalonia. the outbreak and focus on covid- has resulted in a quick transformation in healthcare processes and structures that have produced spillover effects on the delivery of other medical service, and health aspects. one important aspect is related to waiting times. latest reports (december ) ( ) , demonstrated an increase before and due to the pandemic effect on shifting the focus to treat covid- patients, they will suffer an increase. one specifically critical health service relates to transplants. the national transplant organization has released information stating that there has been a % decrease in donors and % decrease in transplants compared to the same period of the previous year ( ) . there is also record of a decreased participation in mandatory immunization programs during the first months of the pandemic ( ) . in short, many non-urgent health services were avoided by the population or postponed by the health services during the pandemic and will have to catch up when possible. in addition, other types of measures were implemented. pané-mena and pascual ( ) list three types of measures implemented on specialist services that included coordination and crisis management measures, support measures refocusing some services exclusively to covid- related cases and referring other series to other centers and logistic measures based on tackling with the lack of devices and materials to provide a suitable healthcare. the economy of spain has suffered increased hardship due to the pandemic. gdp has contracted by - . in the second quarter of , and is currently in technical recession ( ) , falling close to the worst projects of the international organizations by the spanish bank, between % and , % ( ) . moreover, the ibex- stock, has decreased significantly since january, with the lowest value being registered after the declaration of the state of alarm ( figure ). since then, the evolution has been positive, while still below levels of mid-february. the most significant increase was produced when the announcement of the credit loans for the tourist sector was made in mid-june ( ) , as this sector represents an important part of the spanish economy, that in accounted for . % of the gdp, and . million jobs ( ) . [insert figure here] unemployment rates in spain have gone up to . % in the second quarter of from . % in the last quarter of ( ) . in spite of this negative evolution, the unemployment rate is still much lower than in the first quarter of , during the earlier economic crisis, when it reached the peak of . %. however, this number does not consider those workers that have been subject to the temporary regulation of employment "erte" (for its name in spanish) (suspension of work or reduction in hours). at the same time, in the last months, the labor market has changed drastically, as full time job placements have gone down . percentage points ( ) . as a result, the affiliation to social security decreased in the month of july in the amount of - , individuals (most of them men, %) ( ) . whether the economic impact of the pandemic is as large as estimated or even greater, will depend on the speed at which economic activity returns to normal, and on the existence of a possible resurgence or second wave that would bring the economy to a standstill again, before a preventive vaccine or cure for covid- becomes available. spain was one of the first countries to be hardly hit by covid- in terms of cases and deaths. data shows that the country overcome the peak of the spread and intensity of the virus, greatly aided by the very stringent confinement policies that lasted for nearly months, aided by strict enforcement which implied fines reached all-time peak, and resulted in a significant decrease of mobility. having been an early epicenter, it struck the health system by surprise. the virus showed that the health system was not ready to confront a strain of this magnitude. nevertheless, the country managed to be quick in changing the necessary health system structures and increasing its resources to deal with the surge in cases. this encompassed from re-arranging the decentralized health system to a temporarily higher degree of centralization, to the significant roll out of ppe, beds, and medical staff to confront the emergency while it was unravelling. despite the measures to tackle with covid- have been centralized by the ministry of health and implemented homogeneously across the country, we have shown that the pandemic has had a different impact across spanish provinces. this situation has led to a relaxation of lockdown measures on a case-by-case basis. under this system, in order to lift mobility restrictions, ac have been required to submit bi-weekly reports to the health ministry to assess the suitability of their epidemic situation and more particularly their incidence rates. in some cases, provinces within the same ac showed different degrees of severity associated with the incidence rates. this was the case, for instance of the castilla león provinces closer to madrid (e.g. Ávila, segovia), which took longer to increase their mobility compared to others located more to the north. the current debate in terms of public health consists of how to design measures to contain the new wave of cases that are arising in different ac. these measures need to promote the primary care delivered in general practices. primary care plays a core role in prevention and detection of early cases. to enhance the quality of their delivery it is necessary to improve the set of resources available in the current gp premises as well as incentivize the promotion of gp staff. further, they need to increase their capacity to conduct tests. to this extent, there has been a generalized increase of tests in all ac. another key area to address public health measures consists of the redefinition in the organization of long-term care services. two thirds of covid registered deceased in spain occurred in a care home ( ) . these figures show deficiencies in the provision of long-term care under an epidemic crisis. to this extent, the implementation of coordinated protocols with a common framework as well as measures to increase the integration between long-term and primary care, may be two main elements to consider. . the data compiled correspond to the cumulative cases up to th of may . deaths are recorded as a person that has tested positive to covid- and has passed away. cases correspond to those with positive pcr tests. confirmed cases do not come from the sum of hospitalized, recovered and deceased, as they are not mutually exclusive. deceased and recovered could have been hospitalized and therefore be in the two groups. estadística de centros sanitarios de atención especializada situación de covid- en españa la inmunidad de la población española experimenta un leve incremento con una tasa del , % en la segunda ronda del ene-covid sistema de monitoreo de la mortalidad diaria estadística experimental -estimación de defunciones semanales durante el brote de covid- (edes) oxford covid- government response tracker, blavatnik school of government tantas multas propuestas en el confinamiento como impuestas en años de la ley mordaza timing is everything when fighting a pandemic: covid- mortality in spain how effective has the spanish lockdown been to battle covid- ? a spatial analysis of the coronavirus propagation across provinces notas de prensa el coronavirus impulsa la telemedicina en españa el % de los contagiados por coronavirus son trabajadores sanitarios informe sobre la situación de covid- en personal sanitario en españa sistema de información sobre listas de espera en el sistema nacional de salud. situación a de diciembre de covid- : impacto en la actividad de donación y transplantes covid- caida de las vacunaciones el desafio de la covid- para la atencióon especializada contabilidad nacional trimestral de españa: principales agregados cntr (avance) economic forecast for spain perspectivas económicas de la ocde macroeconomic projections for the spanish economy ( - ): the banco de españas contribution to the eurosystems el plan de sanchez para ayudar al turismo se basa en créditos a empresas primer trimestre sanidad estima en . los fallecimientos en residencias durante la epidemia, más de dos tercios con coronavirus población por comunidades y ciudades autónomas demography and population data extensión superficial de las comunidades autónomas y provincias, por zonas altimétricas health at a glance long-term care resources and utilisation: beds in residential long-term care facilities ciudades autónomas y provincias de colegiación, situación laboral y sexo mapa de recursos sociales y sanitarios renave; cne; cnm (isciii). informe. situación de covid- en españa a autonómica viajeros-km el mapa de la ocupación de las uci precios historicos ibex ministerio de educacion y formación. covid- key: cord- - qlr authors: yu, wenzhou; lee, lisa a.; liu, yanmin; scherpbier, robert w.; wen, ning; zhang, guomin; zhu, xu; ning, guijun; wang, fuzhen; li, yixing; hao, lixin; zhang, xuan; wang, huaqing title: vaccine-preventable disease control in the people’s republic of china: – date: - - journal: vaccine doi: . /j.vaccine. . . sha: doc_id: cord_uid: qlr background: china's immunization program is one of the oldest and largest in the world. rates of vaccine-preventable diseases (vpd) are comparable to those in high-income countries. the program's evolution has been characterized by ambitious target setting and innovative strategies that have not been widely described. methods: we reviewed national and provincial health department archives; analyzed disease surveillance, vaccination coverage, and serosurvey data from through ; and, conducted in-depth interviews with senior chinese experts involved early vpd control efforts. results: widespread immunization began in the s with smallpox, diphtheria, and bacillus-calmette guerin vaccines, and in the s with pertussis, tetanus, polio, measles, and japanese encephalitis (je) vaccines. the largest drops in absolute vpd burden occurred in the s with establishment of the rural cooperative medical system and a cadre of trained peasant health workers whose responsibilities included vaccinations. from to , incidence per , population dropped % from . to . for diphtheria, % from . to . for pertussis, % from . to . for polio, % from . to . for measles, and % from . to . for je, averting an average of million vpd cases each year. until the early s, vaccines were delivered through annual winter campaigns using a coordinated ‘rush-relay’ system to expedite transport while leveraging vaccine thermostability. establishment of the cold chain system during in the s allowed bi-monthly vaccination rounds and more timely vaccination resulting in rates of diphtheria, pertussis, measles and meningitis falling over % from to , while polio and je rates fell – %. in the s, progress stalled as financing for public health was weakened by broad market reforms. large investments in public health and immunizations by the central government since has led to further declines in vpd burden and increased equity. during – , the incidence per , population was < . for measles and < . for pertussis, je, meningococcal meningitis, and hepatitis a. from to , the prevalence of chronic hepatitis b infection in children < years fell from . % to . %, a % decline. china was certified polio-free in and diphtheria was last reported in . conclusions: long-term political commitment to immunizations as a basic right, ambitious targets, use of disease incidence as the primary metric to assess program performance, and nationwide scale-up of successful locally developed strategies that optimized use of available limited resources have been critical to china's success in controlling vaccine-preventable diseases. china has one of the largest and oldest immunization programs in the world with over million infants vaccinated each year [ ] . incidence rates of vaccine-preventable diseases (vpd) are similar to those in high-income countries and vaccination coverage is uniformly high. these achievements are the result of enormous effort and evolving responses to new challenges and opportunities over the past years. when the people's republic of china was founded in , the new government faced immense health problems. most of the million population lived in rural areas and in extreme poverty with little access to health care. infant mortality exceeded per births and average life expectancy was only years [ ] . lack of united nations' recognition limited international support and scientific exchange. despite these challenges, the government set ambitious health goals and positioned immunizations as a central to their achievement. prior to liberation, vaccines were prohibitively expensive in china and largely inaccessible except to the very wealthy. in , constitutional principles of the communist party in the shaanxi-ningxia-gansu border region affirmed ''people's rights to freedom from ill health", and in line with this progressive policy, free mass vaccination campaigns against smallpox and cholera were implemented in liberated areas [ ] . this was the first time that large numbers of the rural poor in china benefitted from vaccination. since then, china's public health system has undergone numerous reforms with continued strengthening of vpd control efforts through sustained high-level political commitment to immunizations, strong supportive legal frameworks, increased public finance, dedicated efforts of many scientists and public health professionals and grass-roots health workers, and national scale-up of successful innovative delivery approaches that optimized use of available material and human resources. this article describes china's work on vpd control during to , which has not been widely described. annual vpd incidence from to was obtained from the national notifiable disease reporting system (nndrs). the nndrs is a compulsory reporting system established in for diseases with high epidemic potential including cholera, plague, smallpox, japanese encephalitis (je), meningococcal meningitis, poliomyelitis, diphtheria, pertussis, and measles. data on each case is limited to critical information including name, address, date of birth, date of disease onset, age, sex, and occupation. the nndrs has since been expanded to diseases, including hepatitis a and hepatitis b, tuberculosis, neonatal tetanus, mumps and rubella but the type of data collected has remained largely unchanged. hepatitis b burden, using hepatitis b surface antigen (hbsag) seropositivity as a marker for chronic infection, and hepatitis b vaccination coverage were estimated through national serosurveys conducted in , , and [ ] [ ] [ ] . all three serosurveys relied on random sampling of persons in the disease surveillance point (dsp) surveillance system, a nationally representative sample of rural townships and urban neighborhoods representing approximately % of the total population. vaccination coverage surveys were conducted in selected provinces during - while nationally representative surveys were conducted in , , , , and . all surveys utilized multi-stage probability of selection proportional to population size sampling based on world health organization (who) guidelines [ ] . as a proxy for coverage prior to the s, we searched for references to total numbers of persons vaccinated and total numbers of doses of vaccine produced or administered. a search was conducted for published and unpublished reports on vaccine development and vpd control in china from to , focusing on chinese-language documents not widely available in the published literature, and included manual searches through archived documents at the ministry of health (moh), china center for disease control and prevention, and provincial health departments [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . data on immunization expenditures was collected as part of national epi reviews conducted in , , and . because few reports on vaccination efforts were found prior to the s, we interviewed senior chinese experts who were closely involved in spearheading china's early immunization efforts using a structured open-ended questionnaire. persons interviewed included scientists involved in vaccine research and development; moh officials responsible for development of national policies and goals; and, provincial health staff responsible for planning and implementing vpd control activities. work on immunizations began in earnest as soon as the people's republic of china was founded and more than two decades before establishment of the world health organization's (who) expanded programme on immunizations (epi). in , only four small vaccine manufacturers existed in china (beijing, shanghai, lanzhou, changchun) and developing a secure vaccine supply was a high priority. manufacturing facilities were built in wuhan ( ) and chengdu ( ) to create a network of six regional manufacturers under moh supervision responsible for producing vaccines for the entire country. in , a plan was developed to eradicate smallpox nationwide through free mass compulsory vaccination of the entire population. by the end of , moh announced that over million people (about % of total population) had been vaccinated and smallpox rapidly disappeared from most of the country with the last case occurring in [ fig. ]. building on this success, the state council issued a directive in requiring establishment of a network of epidemic prevention stations (eps) at province, prefecture and county levels, with vpd control a main responsibility. directives on vaccination of children with diphtheria toxoid and bacillus calmette guérin (bcg) were issued in and , respectively, and research was accelerated to develop vaccines against diseases responsible for high mortality including polio, measles, and je. oral polio vaccine (opv) were developed in and was the first attenuated vaccine developed in china. the institute of medical biology, academy of medical sciences was established in kunming, to scale-up opv production. in , moh issued ''measures on implementing preventive vaccination" requiring that all provinces conduct annual winter campaigns to vaccinate children with smallpox, bcg, diphtheria, pertussis, and polio vaccines. in the early of s, combined diphtheria-tetanus-pertussis toxoid (dtp) was introduced. three attenuated measles vaccine strains, beijing- , shanghai- , and changchun- , were developed and introduced in . in contrast to the nationally synchronized smallpox campaigns, campaigns with other antigens were organized at the provincelevel and conducted during colder months since most vaccines were in liquid formulation with limited thermostability and there was no cold chain system. annual meetings were held by moh with provincial health departments and vaccine manufacturers to prioritize limited supplies. to expedite delivery before the vaccines lost potency, a highly coordinated ''rush-relay" transport approach was developed; when vaccines were shipped by the manufacturer, usually by train or truck, the provincial eps was notified by telephone or telegraph when the vaccines would arrive and to mobilize of all forms of transport (motor vehicles, bicycles, pack animals, health staff) to move the vaccines as rapidly as possible to the periphery. local cold storage solutions included use of refrigerators at food processing plants, wells, cellars, burial underground, and wooden boxes built with separate compartments for bottles of frozen water or pieces of ice. usually vaccines were transported from one administrative level to the next within a day and campaigns were completed in a single day. limited vaccine supplies precluded province-wide campaigns, so each province was divided into sections targeted on a rotating basis over a five to six-year period, with each campaign targeting all children under years old. as a result, by school entry most children had received only one or two doses each of diphtheria, pertussis and polio vaccines. while killed vaccines and toxoids could remain potent for up to days, opv and measles were live attenuated vaccines and lost potency within one week, limiting their use to urban areas and impacts. in , a measles epidemic coinciding with rural famine during the great leap forward affected nearly million persons and caused , deaths; during - , epidemic poliomyelitis spread throughout the country with , cases reported [ fig. ]. in , mao zedong's ''june directive" called for renewed focus on rural health. civil unrest at the start of the cultural revolution, however, disrupted vaccine work. during - , outbreaks of poliomyelitis, diphtheria, pertussis and measles started to recur in areas where the diseases had previously been controlled and incidence began to rise, and mass movement of students facilitated transmission of meningococcal meningitis group a resulting in an epidemic in - that affected over million persons and caused , deaths [ fig. ]. in the early s, a number of important public health reforms were instituted that had greatly strengthened vpd control efforts. in , the rural cooperative medical system (rcms) was established with commune-level health stations staffed by a new cadre of part-time peasants (''barefoot doctors") who received three months of training in delivery of basic medical and preventive services, including vaccinations. these grass-roots health workers were responsible for transporting vaccines from county and commune hospitals to their villages and administering vaccinations, which were essentially free with delivery costs covered by pooled rcms funds. vaccine production was increased and the frequency of campaigns were increased with most provinces conducting at least two or three province-wide campaigns each year; live vaccines in the fall and winter and killed in support of the united nations resolution on universal childhood immunization (uci), '' - " coverage goals were included in china's '' th -year plan for national social and economic development, - " setting targets of % percent coverage at province-level with bcg, dpt, opv and measles by months of age by , and % coverage at county-level by . while the uci goals were lower than china's coverage targets and excluded je and meningococcal meningitis, the target age for being fully vaccinated was much younger - months instead of years of age. administering the entire primary series of bcg, dpt, opv and measles vaccines during infancy would require at least six vaccination sessions per year nationwide, ability to delivery vaccinations year-round, and huge investments to extend the cold chain to township levels nationwide. the first coverage survey in china was conducted in provinces with assistance from who in highlighted the magnitude of the challenge [ table ]. to achieve the uci goals, a high-level inter-ministerial leading group consisting of moh, ministry of foreign economic relations and trade, ministry of tv and broadcasting, state education commission, state ethnic affairs commission, and the all china women's federation was formed to oversee planning and progress. april was established as ''national vaccination day" and huge investments were made in cold chain, training, social mobilization, and vaccines. by the early s most of the epi vaccines were lyophilized and more thermostable, enabling delivery to more remote areas. by , annual production had increased to million doses each of opv, dpt, and measles, and million doses of bcg. in , the national people's congress passed a law requiring health authorities at all levels implement a system of planned preventive immunizations that included issuing vaccination certificates to all children and establishing registers to monitor vaccination coverage at township levels and above. with tremendous effort, both '' - " targets were achieved despite large areas of the country still having no cold chain. the first nationwide coverage survey, conducted in to verify achievement of the uci goal documented coverage of % with all recommended bcg, dpt, opv and measles doses by months of age [ table ]. polysaccharide meningococcal meningitis group a and trivalent opv were introduced in and , respectively, and between and the incidence of meningococcal meningitis fell %, from . to . per , while the incidence of poliomyelitis fell %, from . to . per , [ fig. ]. incidences of other target diseases also continued to fall during this period. by , < cases of poliomyelitis were reported nationwide, although low levels of transmission persisted and the target for national elimination by was missed. in support of the world health assembly resolution to eradicate poliomyelitis globally by , the moh issued the '' - national plan for eradication of poliomyelitis", setting targets of < per million by , and zero cases by , with the main strategy supplementary campaigns with opv. during - , million opv doses were administered in province-wide campaigns. in , synchronized nationwide campaigns were approved by the state council targeting all children < years of age with two doses of opv, one dose on december and one dose on january for three consecutive years. the first campaign was conducted in winter / with million opv doses administered and the last case of polio occurred in september . despite epis high profile, financing for immunizations became progressively weaker starting in the s as a result of broad market reforms. farm collectives and the rcms were dismantled, and while epi vaccines were still provided for free, funding for vaccine delivery switched to fee-for-service, usually - rmb paid by parents to the village or township doctor for each dose administered. public health departments were largely left to generate their own operating expenses. in some regions, innovative financing mechanisms were developed to secure additional funding for immunizations, such as the ''epi contract", a lump-sum payment by parents to cover the cost of all epi vaccinations that was pooled and divided between village, township and county-levels to cover delivery costs, as well as an indemnity payment if a child developed a vpd against which he or she had been vaccinated. by , however, central government funds accounted for only % of total immunization expenditures while more than % of expenditures were at village and township levels, resulting in falling coverage and large disparities between more and less developed areas. in , coverage in children - months old with all recommended doses of bcg, dpt, opv and measles had fallen below % in nine ( %) provinces, including seven of the poorer western provinces. despite the challenges financing the immunization program, china was one of only two low-income countries (the other was cuba) to introduce hepatitis b vaccine into their epi when universal infant immunization with hepatitis b vaccine was endorsed by the world health assembly in . at that time, china had the largest disease burden of hepatitis b in the world with approximately % of the population chronically infected. adding hepatitis b vaccine would have tripled government vaccine costs per child from . to . rmb, so market strategies were also used to finance introduction of this expensive new vaccine. the government added hepatitis b to the epi but exceptionally allowed the vaccine cost to be passed to parents. this cost-recovery approach provided a strong incentive to health workers to deliver the vaccine and national coverage with three doses of hepatitis b vaccine in infants increased from % in , to % in , preventing millions of infections and averting hundreds of thousands of deaths. coverage, however, was predictably much lower in less developed areas, particularly the western provinces. requirements for all children to be fully vaccinated, and the regulation on vaccine circulation and immunization that included laws specifying that nationally recommended vaccines be fully funded by the government and administered completely free-of-charge. in , the immunization schedule was expanded to include new antigens (measles-mumps-rubella, attenuated hepatitis a), safer products (acelluar pertussis), and older vaccines that had been excluded from the original epi schedule (je, meningococcal meningitis) and epi vaccine procurement was centralized with moh responsible for procuring all epi vaccines. in , the government launched the new essential public health service package with service categories, including immunizations. government subsidies of rmb per person were provided to village and township-administrative levels to cover the cost of immunization services, and increased to rmb per person in , rmb in , rmb in , and rmb in . currently, all village and townships have the full-time health staff that provide vaccination services to all children at , delivery sites nationwide. there are approximately , epi managers at provincial, prefecture and county levels and , immunization staff at township and village levels. with the majority of china's population now living in urban areas, vaccination has shifted from pulse delivery by village-based health workers to predominantly daily delivery at fixed clinic sites. public health reforms during the past decade have strengthen financing for vaccines and vaccination services resulting in increased and more equitable coverage and historically low vpd burden [ table , fig. ]. in the national survey, coverage of recommended infant doses of bcg, dpt, opv, hepatitis b and measles vaccines was % in of provinces, and % in province, a major improvement from . from to , the incidence of pertussis fell % from . to . per million, measles fell % from . to . per , , meningococcal meningitis fell % from . to . per million, je fell % from . to . per million, and hepatitis a fell % from . to . per , . the last case of diphtheria was reported in . in , china was certified as having eliminated maternal and neonatal tetanus and an all-time low of measles cases were reported nationwide, although numbers of measles cases increased in subsequent years. from to , the prevalence of chronic hepatitis b infection in children under- years old dropped from . % to . %, a % decline. sustained political commitment to immunizations at the highest levels, ambitious targets, strong supporting legal frameworks, a vibrant domestic vaccine industry, and innovative financing and delivery strategies to maximize use of available resources have been key to china's many achievements in vpd control over the past years. immunizations has been a universal right since the founding of the people's republic of china, and have been supported at the highest political levels with passage of laws ensuring access and progressively increasing levels of public finance as the country has developed. goals for universal childhood immunization, smallpox eradication, and poliomyelitis eradication were established in china before comparable un global resolutions and before there was an established cold chain system. selfreliance has been a defining characteristic stimulating the development of innovative strategies to maximize use of limited resources, including mass training of village-based lay health workers to deliver vaccinations, cost-sharing strategies to finance introduction of new vaccines, large-scale social mobilization, use of rapid pulsedelivery approaches to leverage existing vaccine thermostability in areas without cold chain, support for domestic vaccine production, and rapid national scale-up of successful pilots. currently, there are seven state-owned and private vaccine manufacturers in china with annual production capacity of around billion doses, including acellular pertussis, influenza, rabies, yellow fever, japanese encephalitis, hepatitis a and b, rubella, varicella, typhoid, and live and inactivated polio vaccines (ipv). all vaccines recommended in the national immunization schedule are domestically produced. globally, vaccination coverage is stagnating with dpt coverage % since , and % in the african region [ ] . progress toward the global vaccine action plan % coverage target is off-track, and in , nearly million infants were not vaccinated [ ] . many of these children are socioeconomically marginalized, live in fragile or remote settings, and have limited access to health care. a delivery model that relies primarily on nurses and clinical officers to administer vaccinations at fixed sites and provide periodic outreach is costly, places a large burden on parents, and likely to be insufficient to achieve and sustain high vaccination coverage levels in resource-poor countries with large dispersed rural populations [ ] . china has more than half a century of experience successfully using community-based health workers to periodically come to clinics to collect vaccines in cold boxes to take back to their villages for pulse administration increasing rural access, community buy-in, and sustained high coverage levels. more widespread adoption of alternative service delivery approaches may be needed to close remaining coverage gaps. use of vaccine vial monitors that measure cumulative heat exposure and development of pre-filled injection devices further facilitate ease and safety of vaccination by community health workers and could also help address cold-chain challenges in remote areas [ ] . in , menafrivac Ò conjugate meningococcal meningitis a vaccine was the first vaccine prequalified by who for use outside the cold chain in controlled temperature chain (ctc); use of ctc for a mass vaccination campaign in chad would have reduced logistics costs by an estimated % [ ] . in china, in villages where village health workers were provided with hepatitis b vaccine with storage at ambient temperatures at the beginning of hepatitis b vaccine introduction, timely birth dose coverage in infants born at home increased from % to %, with no difference in antibody response compared to newborns who were vaccinated with hepatitis b kept in the cold chain [ ] . recent economic analyses indicate that ctc delivery of the hepatitis b birth dose would be cost-saving in most low and middle-income countries [ ] . disease control has always been the main goal of china's immunization efforts and disease incidence has always been the main metric used to guide development of immunization strategies and to assess immunization program performance. close monitoring of temporal, geographic, and demographic trends in vpd incidence has been critical in china for identifying under-immunized populations and for evaluating the effectiveness of delivery strategies, even when the majority of reported cases are primarily clinically confirmed. in contrast, epis in most low-income countries primarily rely on administrative coverage despite recognized problems with data quality and reliability [ , ] . the - ebola outbreak in west africa has spurred new initiatives to strengthen communicable disease surveillance and more effective use of surveillance data by immunization program managers, including district and sub-district mapping of disease incidence, could strengthen program monitoring and accountability. china's experience with hepatitis b vaccine is an interesting case study on use of cost-sharing to finance the introduction of new vaccines that may be of relevance to middle-income countries ineligible for gavi support. when who recommended universal infant immunization with hepatitis b vaccine in , gdp per capita in china was only us$ . adding hepatitis b vaccine to the infant schedule while allowing health workers to recover the vaccine costs from parents enabled early introduction without external or government financing, and provided a delivery incentive that achieved % coverage nationwide, preventing millions of infections. china's experience suggests that cost-recovery can be an effective interim option for countries to finance the early introduction of expensive new vaccines, particularly if the govern-ment can negotiate lower purchase prices, set caps on allowable charges, and provide subsidies for the poor. china also has much to learn from experience in other countries. challenges include strengthening delivery of immunizations within a larger package of integrated health services, balancing policies that make vaccines affordable against those providing incentives for new vaccine research and development, financing new vaccine introductions, and vaccine hesitancy. for many years, vaccination was one of the few preventive services that village and township doctors were required to deliver and china's immunization program is facing the challenges of navigating integration of immunization with delivery of a much wider range of other services. introduction of new expensive vaccines into the recommended schedule remains a challenge. the current infant schedule requires separate injections and there is urgent need for increased funding to develop and add combined products to the schedule, such as dpt-hepatitis b, dpt-hepatitis b-haemophilus influenzae type b (hib), and dpt-hepatitis b-hib-ipv. finally, while public trust in immunizations remains high, china has not been immune to problems of vaccine hesitancy. widespread internet access has facilitated rapid dissemination of often unfounded claims of harmful effects due to vaccination that have had negative effects on vaccination coverage [ ] . these and other challenges will require new approaches as china's immunization program continues moving forward. this work was supported by united nations children's fund for the literature review and the in-depth interviews of chinese immunization experts (yh - ). a -year history of disease prevention and control in china new china's achievements in health work chinese communist party. constitutional principles of the shaanxi-gansu-ningxia border region viral hepatitis in china. seroepidemiological survey in chinese population (part one) - . beijing science and technology press: beijing epidemiological serosurvey of hepatitis b in china -declining hbv prevalence due to hepatitis b vaccination prevention of chronic hepatitis b after decades of escalating vaccination policy world health organization. the epi coverage survey. geneva: world health organization, expanded programme on immunization regarding the launching of the autumn campaign for smallpox vaccination ministry of health of the people's republic of china. measures for implementing preventive vaccination ministry of health of the people's republic of china. regulations on acute infectious diseases, number ministry of health of the people's republic of china. report of the survey of the third % vaccination coverage target of the national expanded programme on immunizations ministry of health of the people's republic of china. compilation of national immunization documents: s national file ministry of health of the people's republic of china. report of the national review of the expanded programme on immunizations ministry of health of the people's republic of china. report of the national review of the expanded programme on immunizations. beijing: people's health publishing house state council of the peoples's republic of china. regulations of vaccine distribution and vaccination, number ministry of health of the people's republic of china. report of the national review of the expanded programme on immunizations national certification committee for the eradication of poliomyelitis in the people's republic of china. documentation for the certification of poliomyelitis eradication hubei province epidemic prevention station. expanded programme on immunization contract system tested study on financing the expanded program on immunizations in selected regions of china routine immunization services costs and financing in china progress and challenges with achieving universal immunization coverage. who/unicef estimates of national immunization coverage (data as of assessment report of the global vaccine action plan strategic advisory group of experts on immunization. geneva: world health organization the cost structure of routine infant immunization services: a systematic analysis of six countries can thermostable vaccines help address cold-chain challenges? results from stakeholder interviews in six low-and middle-income countries economic benefits of keeping vaccines at ambient temperature during mass vaccination: the case of meningitis a vaccine in chad hepatitis b vaccination of newborn infants in rural china: evaluation of a village-based, out-of-cold-chain delivery strategy costeffectiveness of the controlled temperature chain for the hepatitis b virus birth dose vaccine in various global settings: a modelling study tracking progress towards universal childhood immunisation and the impact of global initiatives: a systematic analysis of three-dose diphtheria, tetanus, and pertussis immunisation coverage the immunization data quality audit: verifying the quality and consistency of immunization monitoring systems loss of confidence in vaccines following media reports of infant deaths after hepatitis b vaccination in china the authors declare no conflicts of interest. key: cord- -cufyqv h authors: singu, sravani; acharya, arpan; challagundla, kishore; byrareddy, siddappa n. title: impact of social determinants of health on the emerging covid- pandemic in the united states date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: cufyqv h a novel coronavirus ( -ncov) caused a global pandemic in the months following the first four cases reported in wuhan, china, on december , . the elderly, immunocompromised, and those with preexisting conditions—such as asthma, cardiovascular disease (cvd), hypertension, chronic kidney disease (ckd), or obesity—experience higher risk of becoming severely ill if infected with the virus. systemic social inequality and discrepancies in socioeconomic status (ses) contribute to higher incidence of asthma, cvd, hypertension, ckd, and obesity in segments of the general population. such preexisting conditions bring heightened risk of complications for individuals who contract the coronavirus disease (covid- ) from the virus ( -ncov)—also known as “severe acute respiratory syndrome coronavirus ” (sars-cov- ). in order to help vulnerable groups during times of a health emergency, focus must be placed at the root of the problem. studying the social determinants of health (sdoh), and how they impact disadvantaged populations during times of crisis, will help governments to better manage health emergencies so that every individual has equal opportunity to staying healthy. this review summarizes the impact of social determinants of health (sdoh) during the covid- pandemic. the novel coronavirus ( -ncov) spread rapidly throughout china during the chinese new year in late january of , a time of increased domestic and international travel for chinese people. the first four cases of the novel coronavirus were reported on december , . all four cases were linked to the huanan seafood wholesale market in wuhan, a city with more than million people and the capital of hubei province in central china. the symptoms were described as a pneumonia of unknown etiology ( ) . early cases show history of contact with the seafood market. later and more recent cases were found to be transmitted via human-to-human contact ( ) . the disease caused by -ncov was named covid- by the world health organization (who) on february , ( ) . the cdc confirmed that individuals with preexisting diagnoses of asthma, cardiovascular (cvd), hypertension, chronic kidney disease (ckd) and/or are elderly, immunocompromised, or obese have higher risk of severe illness from covid- ( ) . of the listed at-risk health demographics, asthma, cvd, hypertension, ckd, and obesity can be caused by discrepancies in socioeconomic status (ses). the cdc reports that % of patients who have died from covid- had at least one preexisting condition ( ) . because these conditions specifically put an individual at higher risk of being infected with sars-cov- , these vulnerable populations must be given the resources needed to endure infectious outbreaks. this review summarizes the impact of social determinants of health (sdoh) during a pandemic of covid- . it can provide essential information to support the government's decisionmaking body to strategically manage health emergencies at community, national, and even international levels in the future if a similar situation was to arise. calculated measures can be taken to prevent or reduce further transmissions in a vulnerable population that is at risk. the social determinants of health (sdoh) are social and economic conditions that are categorized into five key determinants as summarized in figure . health and health care, social and community context, neighborhood and built environment, education, and economic stability ( ) . health and health care include access to health care, access to primary care, health insurance coverage, and health literacy ( ) . low health literacy can cause patients difficulty with navigating the complex healthcare system and understanding medical advice or prescriptions. individuals without health insurance are less likely to utilize or even have access to primary care, which makes detecting and managing chronic conditions, such as cvd, asthma, diabetes, and cancer, difficult. social and community context are the circumstances a person lives, learns, and works in. this domain of sdoh includes community involvement and discrimination. lower mortality rates are associated with social and community support and cohesion. neighborhood and built environment include housing, neighborhood, transportation, access to healthy foods, air quality, water quality, and access to green space ( ) . air pollution has been shown to be associated with incident asthma. the cdc has confirmed that individuals with asthma are at higher risk for severe illness from covid- ( ) . safety plays a major role in health. people are more likely to walk or run outside if they feel safe in their neighborhood. without the worry about crime and danger, safe neighborhoods also allow people to maintain good mental health. immune function is influenced by psychological stress. algren et al. state that individuals living in deprived neighborhoods were observed to have more stress when compared to those living in non-deprived neighborhoods. stressors of those living in deprived neighborhoods include, "overcrowding, high crime rates, perceived danger, poor transportation, poor housing, disrepair, limited services, poor infrastructure, and a lack of social support" ( ) . education includes high school graduation, enrollment in higher education, and language and literacy. the higher one's level of education, the higher his or her life expectancy is ( ) . it is important to disclose information regarding health in a patient-specific manner, taking into account the patient's education level. economic stability includes employment, poverty, food security, and housing stability. the american medical association (ama) states that as the poverty level increases, the percentage of adults who are years and older with an activity-limiting chronic disease increases ( ) . unemployment impacts an individual's health in many ways, as it has associations with depression, domestic violence, substance abuse, and physical illness. specific examples of sdoh include income, education, employment, and social support ( ). simply put, they are conditions into which one is born, grows, lives, works, and ages ( ) . they look at the person as a whole. altogether, these conditions impact health status of individuals and communities. disparities in any of these conditions are translated into a measure of social hierarchy called socioeconomic status (ses). the lower individuals are on the spectrum of ses, the poorer health outcomes they face. due to poor outcomes, life expectancy decreases for those at the lower end of the spectrum ( ). socioeconomic inequality piles health complications on top of the financial woes already burdening disadvantaged segments of the population. the five sdoh are interrelated and played major role during covid- pandemic. for example, education level of an individual can impact his or her occupation, which determines economic stability and income level, which can impact the type of healthcare the individual is eligible for and what neighborhood the individual lives in, which then impacts the social and community context the individual is surrounded by and those factors played important role in current covid- pandemic. therefore, one can conclude that socioeconomic factors play a key role in infection and mortality rates. specific examples include some county's in new york, such as bronx, brooklyn, and queens have suffered higher mortality rate compared to other county's suggested that large of population of individuals with low economic status lived in these areas. another example to consider is from the perspective of a child growing up in a family that does not have much economic stability. the child's parents have low-income jobs, which forces them to live in povertystricken neighborhoods that may not have a great school system. this child will not obtain the same quality of education as a child that lives in an affluent neighborhood that has a richer school district. since, public schools in the u.s. are funded by local, state, and federal governments ( ) . funding comes from income and property taxes. affluent neighborhoods and districts collect more taxes; therefore, they have more funding. low-income districts collect less funding and have substandard school facilities and teachers who are the least qualified ( ) . therefore, below average quality of education will not lead to high college admission test scores, which will keep the child out of top colleges if he or she chooses to pursue a college education. even with a low-tier college education, the child may not have many high-income job opportunities. this will land the child in the same position as his or her parents, with a low-income job living in a poverty-stricken neighborhood. ham et al. ( ) state that children living with their parents in poverty-stricken neighborhoods are more likely to end up in the same situation themselves later in their life. the five determinants can be thought of as a cycle of events that impact one another rather than as individual entities even in current covid- pandemic. health literacy is defined by the u.s. department of health and human services (hhs) as "the degree to which individuals have the capacity to obtain, process, and understand basic health information needed to make appropriate health decisions" ( ) . this includes the ability to read and understand healthrelated pamphlets, prescriptions, written instructions from a healthcare provider, etc. not being able to read or understand health-related information makes it difficult for individuals to take care of themselves, even if the awareness to do so is present. low health literacy is associated with poorer health outcomes. certain population groups have been noted to have low health literacy compared to other groups ( ) . those who are living in poverty, not highly educated, from a certain race/ethnic group, or with disabilities are more likely to have low health literacy ( ) . patients who demonstrate low health literacy may have high overall literacy and high verbal fluency, which causes the patient to present as having high health literacy. it is important to recognize people who may have low health literacy especially during times of a pandemic, because health literacy is an important means of preventing communicable diseases, such as covid- . understanding infectious diseases to a certain degree, including mode of transmission and viability of pathogens, will help people readily accept the circumstances in situations like this rather than question the recommendations. health literacy can allow people to understand their responsibility of adhering to social distancing and other recommended measures during the covid- pandemic and the reasoning behind the measures being taken to prevent the spread of the virus. a gallup poll conducted in the months of april and may of looked at how many americans considered social distancing to be significant by assessing their confidence level in the impact social distancing has on reducing the spread of covid- . further, determined whether each group that was divided by confidence level followed social distancing. the study found that % of americans were "very confident" and % were "moderately confident" in their belief that social distancing helps save lives during covid- pandemic ( ) . however, % of americans who participated expressed skepticism about social distancing and its role in saving lives. overall, % of americans who participated in the poll reported that they "always" or "very often" practiced social distancing, which included measures such as avoiding crowded places and leaving their homes unnecessarily. of those who were "very confident" or "moderately confident" that social distancing makes a difference, and % reported that they "very often" practiced social distancing, respectively. fifty-seven percentage of those who expressed skepticism "very often" practiced social distancing. the percentages were drop when it comes to "always" practicing social distancing. seventy-one percentage of those who were "very confident" that social distancing making a difference "always" practiced it, whereas % of those who were "moderately confident" "always" practiced it. only % of those who were skeptical "always" practiced social distancing. therefore, health literacy was played a major role in whether an individual understands a health emergency situation, such as covid- pandemic, and whether he or she will follow recommendations, such as social distancing. access to health care is described as the "timely use of personal health services to achieve the best possible health outcomes" by the national academies of sciences, engineering, and medicine ( ) . many people face barriers to health care, which may hinder their ability to take responsible actions toward their well-being. barriers include limited or no access to transportation for health appointments, lack of health insurance, limited education about health care, limited health care resources, provider hours limited to work hours, etc. lack of health insurance is usually seen in populations with lower incomes and minorities. a study by gallup and west health found that % of adults in the u.s. revealed that they would not seek healthcare if they experienced a fever and dry cough ( , ) . fever and dry cough are the most common symptoms of covid- . when adults were specifically asked whether they would seek healthcare if they had believed they had been infected with covid- , % still answered that they would not ( ) . the individuals that reported that they would not seek healthcare were non-white adults under the age of who had a high school education or less earning less than a $ , income per year ( ) . reluctance to seek healthcare is associated with socioeconomic status. hispanics and african americans were less likely to have health insurance compared to non-hispanic whites ( ) . without health insurance, primary care visits may not be feasible, or people may hesitate to use health care resources. this puts those without health insurance at risk of not being screened for chronic conditions, such as cvd, hypertension, asthma, and diabetes. access to health care also relies on the availability of resources ( ) . those who are minorities and/or have low incomes already face difficulty-accessing healthcare. many of them primarily depend on student-run clinics for obtaining healthcare. the university of nebraska medical center college of medicine has a student-run clinic, called the student health alliance reaching indigent needy groups (sharing) clinic, which provides low-cost primary health care and services to the underprivileged populations in the omaha community. this clinic has been closed due to the covid- pandemic. therefore, the underserved populations who already face barriers to healthcare now face a barrier to access primary care at these student-run clinics, which are their primary means of maintaining their well-being. food deserts are neighborhoods that are defined as low income areas with little access to healthy foods by the u.s. department of agriculture (usda) ( ) . a study found that there was association between food deserts and cardiovascular risk factors in an atlanta metropolitan area. they found that income was more strongly associated with cvd risk than access to healthy food ( ) . recognizing that income had a greater part than location of residence, they then studied individual income vs. neighborhood income by observing people with low individual income living in low income neighborhoods and compared them with people with low individual income living in high income neighborhoods. results showed that individual income is associated with higher risk of cvd than neighborhood income or food access. those with high individual incomes who lived in low-income neighborhoods had lower cvd risk than those with lower individual incomes who lived in lowincome neighborhoods ( ) . individuals with high income who lived in neighborhoods with poor healthy food access had better cardiovascular profiles compared to individuals with low income living in high-income neighborhoods. this confirms that the perceived association between food deserts and cvd risk is partly due to individual income status rather than access to healthy foods. further, another study suggested that there is a similar relationship between ses and cvd and found that mortality from cvd is higher in individuals with lower education levels and lower occupational class ( ) . the correlation between lower income and heightened risk of cvd, with cvd increasing the risk for serious illness related to infection from covid- , suggests an inverse correlation between income and covid- health complications. low income has also been associated with hypertension and ckd. healthier foods, such as fruits and vegetables, tend to be costlier. this makes it hard for low-income families to afford healthy diets. individuals have access to high amounts of processed meats and fats instead of fruits and vegetables in low-income neighborhoods and food deserts. a qualitative study done by suarez et al. has revealed that . % of participants living in food deserts and those with low incomes reported that they "always" or "most of the time" have fruit available at home ( ) . this is compared to . % of participants that do not live in food deserts and are in the highest income category. . % of participants living in food deserts and those with low incomes reported that they "always" or "most of the time" have dark green vegetables available at home compared to . % that do not live in food deserts and are in the highest income category ( ) . qualitatively, family income demonstrated a stronger association with diet, blood pressure, and ckd than living in a food desert ( ) . the same study also found that serum carotenoids were low in individuals living in food deserts and individuals with low incomes ( ) . carotenoids are a measure of fruit and vegetable intake. they also found that average protein, potassium, sodium, calcium, and magnesium intake were lower among individuals living in food deserts and individuals with low incomes. measuring levels of these minerals gives insight into the measure of dietary acid load in an individual's body. low levels of these minerals indicate a higher measure of dietary acid load ( ) . foods rich in protein (meat, cheese, eggs, etc.) increase acid production in the body. fruits and vegetables lead to base production. diets high in acid induce metabolic acidosis, which can lead to hypertension, ckd, insulin resistance, diabetes, and other complications ( ) . a high dietary acid load has also been linked to obesity ( ) . food deserts contain more fast food restaurants than grocery stores. individuals living in a food desert tend to have a poor diet, which increases the risk of obesity ( ) . obesity is classified as a bmi greater than or equal to by the cdc ( ) . individuals living outside of food deserts have better access to grocery stores and are more likely to have diets consisting of more fruits and vegetables. these individuals are less likely to be at risk of obesity ( ) . individuals who are obese are at higher risk of being diagnosed with a breathing disorder known as obesity hypoventilation syndrome, also known as pickwickian syndrome. it is not clearly understood why this syndrome affects obese individuals, but it is thought that extra fat on the neck, chest, or abdomen may make breathing deeply difficult. this leads to a buildup of carbon dioxide and decreased amounts of oxygen in the blood. hormones that affect breathing pattern may also be secreted in response to difficulty in breathing ( ) . body mass index (bmi) is calculated by dividing a person's weight in kilograms by the square of their height in meters (kg/m ). bmi is a screening tool used to determine whether a person is in a healthy weight range, overweight, or obese. a bmi of < . classifies a person as underweight. bmi between . and < is normal. bmi between . and < puts an individual in the overweight range. bmi . or higher puts an individual in the obese range ( ) . a study with patients who tested positive with covid- was conducted in seattle. of the patients, were classified as overweight and as obese. the study showed that % of the obese patients required mechanical ventilation ( ) . sixty-two percentage of the obese patients died from the virus. sixty-four percentage of non-obese patients required mechanical ventilation, and % of them died from the virus ( ) . the percentages of requiring mechanical ventilation and deaths are clearly higher in obese individuals compared to nonobese individuals. a bmi > was found to be the second strongest independent predictor of hospitalization in patients with covid- at an academic hospital in new york city ( ) . a study in france that collected data from patients who tested positive for covid- reported that the ones who required mechanical ventilation were those who had a bmi greater than or equal to . the study mentions that the reason behind why patients usually require mechanical ventilation is because of impaired respiratory mechanics, increased airway resistance, and impaired gas exchange ( ) . in obese individuals, respiratory problems include low respiratory muscle strength, possible due to the extra fat on the neck, chest, or abdomen as mentioned earlier, and low lung volumes due to the extra fat making it difficult to take deep breaths ( , ) . the study also concluded that the disease severity of covid- increased with increasing bmi ( ) . unfair or unjustified socially structured actions against a certain group or population contribute to discrimination. these actions tend to favor the affluent and powerful population at the detriment of the impoverished population. discrimination occurs at both the individual and structural level in health care ( ) . individual discrimination includes negative interactions between a patient and a health care provider due to race, gender, etc. negative interactions may limit health care resources and well-being of the patient. structural discrimination is seen in the form of residential segregation according to race or ethnic groups, unequal job opportunities due to gender, unequal access to quality education, inequalities in incarceration, etc. forms of structural discrimination can trickle down to affect individuals and populations in terms of health care. residential segregation plays a major role in the inequalities observed between african americans and caucasian populations. african americans are more likely to live in high-poverty neighborhoods than other americans. high-poverty neighborhoods consist of low quality and poor schools, limited access to healthcare and jobs, weak social networks, high rates of crime, pollution, and congestion ( ) . because of congestion in impoverished neighborhoods, it can be difficult to follow social isolation recommendations. keeping physical distance from others may not be an option for some families. many individuals living in poverty are also in a predicament during times like this when people are asked to work from home, because minorities and african americans are more likely to hold jobs in professions in which it is not feasible to work from home ( ) . many latinos and african americans are facing the dilemma of having to pay rent and putting food on the table vs. staying home and keeping their families healthy during this covid- outbreak, as they are the ones who work in warehouses, food industry, construction, janitorial services, etc., and these are jobs that cannot be done from home ( ) . though race and ethnicity data are available for only % of those who have fallen victim to the virus, discrimination is clearly evident in the existing data ( ) . new york city, the hardest hit city in the u.s., has had more latinos per capita fall victim to covid- than any other ethnic groups ( ) . latinos make up % of new york city's population. approximately % of covid- deaths in new york city are of latinos. african americans make up % of the city's population and % of covid- deaths ( ). overall, african americans are . times more likely to die from this virus compared to their counterparts of other races. broken down by state, the statistics are alarming. african americans make up ∼ % of the u.s. population, and their population as a whole has endured % of covid- deaths. on the other hand, caucasians are disproportionately facing deaths based on which u.s. state they reside in. as a whole, caucasians are less likely to die than expected at . times their counterparts ( ) . social support is an important component of an individual's wellbeing. social cohesion, one of the terms used to describe social relationships, describes how strong relationships are and whether there is a sense of solidarity among members of a community ( ) . social capital, an indicator of social cohesion, measures the extent of shared group resources within a community, perceived fairness, perceived helpfulness, group membership, and trust ( ) . researchers found these aforementioned measures of social capital to be inversely correlated with mortality ( ) . social capital decreases as income inequality increases. it is believed that social capital is the element that relates income inequality and mortality ( ) . social cohesion is associated with lower neighborhood violence, better self-rated health, and less stress/anxiety. stress has many impacts on the body, including on the immune, cardiovascular, and neuroendocrine systems. a study has showed that higher amounts of social support were associated with lower levels of atherosclerosis in women predisposed to a higher risk for cvd ( ) . another study in california demonstrated that social support among mexican adults served as a barrier against the detriments of the discrimination they faced ( ) . it is evident that people and communities have come together during this difficult time. medical students have been suspended from clinical clerkships, which prevents students from all patient care activities. across the nation, medical students have been helping out resident physicians and attending physicians who are on the front-line with childcare, pet care, and running errands. medical students from the university of nebraska medical center have also been utilizing time off from clinical clerkships by volunteering in the community. those who know how to sew have been sewing masks for front-line workers due to a shortage of personal protective equipment (ppe). individuals have been running errands for the elderly who are more vulnerable to falling ill with the virus. during times of a global health crisis in which there is a call for social isolation, such as the one we face currently with the covid- pandemic, it is important to find ways to maintain communication and social cohesion to preserve each other's well-being. food is an essential human need. it plays a major role in an individual's health and quality of life. consumption of healthy foods is associated with lower risk of chronic health conditions. a healthy diet consists of a myriad of fruit, vegetables, grains, protein-rich foods (seafood, lean meats, poultry, legumes, soy products, eggs, etc.), and fat-free or low-fat dairy. poor diet and nutrition have been linked to chronic conditions, such as cvd, hypertension, diabetes, and even cancer ( ) . the individual components of the neighborhood and built environment domain of sdoh are intertwined and affect one another. there are many barriers to the access of healthy foods. transportation, another component of the neighborhood and built environment domain, plays a major role in the access to healthy foods. a study from to found that on average, the nearest grocery store to households in the u.s. was . miles ( ) . this makes it difficult for those without their own vehicles or access to public transportation to make a trip to the grocery store. food deserts are neighborhoods that are defined as low income areas with little access to healthy foods by the u.s. department of agriculture (usda) ( ) . these neighborhoods are more likely to contain fast food restaurants and convenience stores than grocery stores. fast food restaurants and convenience stores contain options that are of lower quality and more unhealthy foods (higher saturated and trans-fat and higher calories). individuals living in food deserts are more likely to have poor diets and nutrition as a result. compared to caucasian neighborhoods, african american and latino neighborhoods are more likely to contain a higher amount of fast food restaurants and convenience stores. this explains why minority populations are more likely to have negative health outcomes than their racial counterparts. living in a food desert puts an individual at a higher risk of obesity, which is discussed in another section. income also plays a role in access to healthy foods. studies have shown that low-income families depend on cheap foods that happen to be low in nutrient density. healthy foods, such as fresh fruits and vegetables, are usually more expensive than processed foods. those who cannot afford fresh foods opt to the processed foods option, which is unhealthy ( ) . it is important to recognize food deserts and communities that do not have access to healthy foods, especially during a pandemic, when supplies may be in shortage to begin with. if supplies are in shortage, it will be difficult for those who have limited access to healthy foods or food in general to maintain their diet and nutrition altogether. individuals will also have to make more trips to grocery stores to obtain groceries, which can put them at risk of acquiring the virus. minority and low-income populations living in food deserts may face more difficulty accessing healthy foods during the covid- pandemic due to customers overbuying and stocking groceries. this could be more of a problem in areas that are food deserts compared to affluent areas. air quality, water quality, pollution, housing, and access to green space can all be discussed under this section. health disparities due to neighborhood and environmental conditions can be understood by studying how certain population ends up in certain geographic locations. there is an association between racial minorities and geographic location of their residences. latinos and african americans are more likely to live in neighborhoods that have higher exposure to pollution from airborne particles such as chlorine, aluminum, and carbon ( ). this is due to the fact that high-poverty neighborhoods in which latinos and african americans live are more likely to be located near factories, refineries, and landfills that emit pollutants. for a third of americans, groundwater was found to be the major source of drinking water. groundwater near factories, refineries, and landfills tends to be polluted with hazardous wastes ( ) . researchers have suggested that air pollution can make individuals more vulnerable to acquiring covid- . they reason that pollution particles are acting as vehicles for the virus, which makes it easier for the virus to be transmitted from personto-person. researchers say that air pollution may have worsened the outbreak. this may be due to the fact that air pollution weakens the immune system, which decreases one's ability to fight infections ( ) . a study recently found that an increase in the size of pollution particles, referred to as pm . , can have an effect on the spread of covid- . the study found that an increase of microgram per cubic meter was associated with an % increase in deaths related to covid- ( ) . safety also plays a major role in health. high-poverty neighborhoods are more likely to contain higher rates of crime, which decreases safety of community members. people are more likely to utilize available green space for walking, running, or exercising. another issue in high-poverty neighborhoods is availability of green space. these neighborhoods are crowded to the point where there is minimal green space available for residents. social distancing has been the key to flattening the curve and decreasing transmission of covid- . in neighborhoods that are crowded, social distancing may not be feasible. this puts individuals living in crowded neighborhoods at a higher risk of becoming ill with the virus, as well as increases the rate of transmission of the virus. low-income families tend to live in public housing of poor quality ( ) . a study found that public housing was found to have several infestations with cockroaches, mice, rats, etc. ( ) . mold, lack of air conditioning, and tobacco smoke were also a common find ( ) . this study also found that % of children who lived in public housing were diagnosed with asthma compared to only % of those living in single-family homes ( ) . low-income families may be at a higher risk of acquiring covid- . for most jobs and higher educational degrees, a high school diploma is required ( ) . without a high school education and diploma, job opportunities become slim. lack of or less job opportunities can lead to poverty. poverty can lead to negative health outcomes as discussed previously. the home and school environment is the major determinants of whether a student will graduate high school. studies have found that students with parents who are not involved in their education are more likely to drop out of high school. schools with higher crime rates are more likely to higher dropout rates ( ) . students from low-income households are more likely to attend low quality schools and have less access to educational resources. during the covid- pandemic, schools have had to switch to online education. these children may not have access to computers, or internet. this means that children from high-income families are at an advantage when it comes to learning remotely, while children from low-income families are losing ground. children with parents who are educated and have obtained higher educational degrees may encourage their children to keep pursuing their academic work ( ) . non-educated parents may undervalue education compared to educated parents and downplay the importance of maintaining academic standards for their children. this does not make the educated parents better than the noneducated parents. rather, it is a matter of being aware of and having experiences of how to navigate situations keeping in mind that education is important regardless of the hardships. children with non-educated parents may not be getting the support that children with educated parents are getting while having to go to school online during this pandemic. some children are stimulated to do well in a classroom setting and having to participate in distance learning may impact their academic merit. individuals with lower levels of education and minorities are more likely to have limited english-speaking skills and lower literacy. those with language and literacy barriers were noted to have worse health status, chronic health conditions, lack health insurance, and have difficulty following medication directions ( ) . the u.s. is home to many who speak a language other than english. a new initiative, called the "covid- health literacy project, " started by medical students and physicians at harvard medical school, is intended to bridge the language barrier gap. this initiative has translated important covid- information in over languages ( ) . languages that information can be translated into include arabic, bengali, chinese, dutch, filipino, german, greek, gujarati, japanese, hindi, and many more. information about the virus, prevention methods to avoid becoming ill with the virus, and treatment options available are included in the fact sheets. this has made it possible to educate the public even with existing language barriers. creating awareness of the virus and educating the public about the situation and what precautions to take is an important step toward controlling the spread of the illness. the level of education one obtains is a major determinant of the type of job one has, the income they earn, and benefits such as health insurance, paid sick leave, and parental leave ( ) . racial disparities also exist in the workplace. caucasians are more likely to hold white-collar clerical jobs, while african americans and minorities are more likely to hold blue-collar service jobs ( ) . discrimination in the workplace can lead to stress, anxiety, depression, and negative health outcomes. individuals who are unemployed are more likely to have stress-related conditions such as cvd, hypertension, and diabetes, which are all risk factors for covid- ( ) . the u.s. economic activity has slowed down with stay-athome and quarantine orders. many people have lost income by losing their job, having their salary reduced, or being put on unpaid leave ( ). approximately . million americans have filed for unemployment aid in the last seven weeks ( ) . approximately % of hispanics and % of african americans have reported that they have faced wage or job loss due to the covid- pandemic compared to % of caucasians ( ) . these percentages have increased from , , and %, respectively, since march ( ) . unemployment or job loss means individuals do not have or lose their employer-sponsored health insurance. congress has allowed uninsured individuals to be tested for covid- , however, treatment of the virus is not covered ( ) . to address the economic downfall, the president of the united states signed the coronavirus aid, relief, and economic security act (cares) stimulus bill into legislation on march , ( ) . the stimulus bill provides a payment of $ , for each u.s. citizen or u.s. resident alien with an income of $ , or less ( , ) . $ is added to the $ , for each dependent child ( ). though it may seem simple, the criteria that have to be met to receive a stimulus check are numerous and complicated. a schedule for distribution of stimulus checks has not been established. as of now, one stimulus check has been sent out to qualifying individuals ( ) . the president and congress have mentioned releasing a second check; however, nothing is set in stone ( ) ( ) ( ) . one check of $ , may not be enough for most families. this could certainly be a hindrance for families to eat healthy foods, as they will have to use the money wisely until either another check will be distributed, or the pandemic comes to an end and people can return to work. there is a fine line between trying to decrease the spread of covid- and preventing the progression of economic decline. it is evident that social distancing and quarantine methods are helping to flatten the curve, however, at the expense of the country's economic stability. social distancing was recommended early on by each state's governors, and then a lockdown followed. two states, georgia and idaho, demonstrate the rise in incidence of cases in the months of march and april, a decline toward the end of may, and rise again in the months of june and july ( , ) . georgia's governor issued a lockdown on april , , and idaho's governor issued a lockdown on march , ( , ) . during lockdown, non-essential workers were directed to stay at home and only go out to the grocery store or to a pharmacy if needed. social distancing was to be followed strictly during lockdown. georgia's lockdown was lifted on april , ( ) . at the end of april, georgia saw a slight increase in incidence of cases. by mid-june, the incidence is higher in georgia than before lockdown was implemented, and it is only increasing. idaho's governor, on the other hand, issued a lockdown on march , ( ) . there was a rise in incidence at the beginning of april and then a decline by mid-april. idaho's lockdown was lifted on april , ( ) . the incidence was < cases in idaho from mid-april to the beginning of june. since june , , the incidence is on the rise, and it is higher in june and july compared to when lockdown was implemented in march. the incidence of covid- cases overall in the u.s. is shown in figure ( ) . it is evident that incidence is once again on the rise as lockdowns have been lifted across the nation and social distancing is no longer being followed as strictly as during the lockdowns (figure ) . it is understandable that the nation's economy is an important consideration when implementing a lockdown across the nation. we will have to wait and see what the future holds for our nation's economy while we try to eradicate covid- . pandemics are more of a social problem than a healthcare problem. the population that lives in poverty and in neighborhoods that are overcrowded with poor maintenance and sanitation is being disproportionately affected by covid- . it is imperative to provide additional aid for low-income families, such as the stimulus check. this is especially important during times of disease outbreaks, as this is a vulnerable population that is at risk for serious illness. the root cause of being a part of the vulnerable population at risk during outbreaks comes down to income level and racial/ethnic identification. lower income has been associated with poor dietary intake and habits. minority groups, such as latinos, and african americans are at a disadvantage due to individual and structural discrimination, and they are more likely than their caucasian counterpart to be vulnerable to negative health outcomes. therefore, it is evident that the sdoh have been overlooked during this pandemic. dr. richard clarke cabot, an american physician, was the first in the u.s. to consider socioeconomic, family, and psychological factors when practicing medicine (https://www. ncbi.nlm.nih.gov/books/nbk /). he observed that there was a correlation between lower socioeconomic status of patients and their probability of succumbing to illness. historical reports have shown that poverty, inequalities, and sdoh facilitate the spread of infectious diseases. inequalities in health and healthcare can further add to disparities in morbidity and mortality. quinn et al. suggested that existing studies of influenza pandemics have not recognized the importance of health inequalities nor have they attempted to analyze differences in socioeconomic factors and how they impact health during times of a health emergency figure | the wax and wane in new cases of covid- per day in usa, new york, georgia and idaho. the graphs were generated using the online data form cdc and john hopkins web sites. ( ) . therefore, it is imperative to respond rapidly and effectively during times of a health emergency. in order to achieve that, it is crucial to be educated about all of the factors that may play a role in health and healthcare before an outbreak of disease even occurs. having insight into factors that play a role in health and healthcare, such as sdoh, can facilitate access to medical and non-medical resources to those who are socioeconomically disadvantaged. public education and creating awareness of the severity of the virus is also important. awareness of the disadvantaged population that is more vulnerable than the average individual and the rapid spread of covid- should motivate individuals to reduce exposure to others to stop the spread of the disease. the key to fighting an outbreak is to take into account the various factors that play a role in the well-being of a nation. appropriate and timely education, health care, and social services can be effective measures taken to address outbreaks, such as covid- . integrating sdoh into efforts to eliminate disparities in health and healthcare can be the solution to reducing disease globally. this can be done through the assembly of an interdisciplinary team that consists of health care professionals, public health professionals, anthropologists, sociologists, researchers, governments, national institute of health (nih), center for diseases control (cdc), world health organization (who), and others, who can all contribute to analyzing and understanding the various factors that play a role in causing health disparities in populations that already face socioeconomic inequalities. it is also crucial to assess what actions and measures were taken correctly and what went wrong during this pandemic, so that, we will be prepared to handle things in a more efficient manner if any future pandemics arise. every person, regardless of where they live, what race they are, and what income they have, should have equal opportunities to stay healthy. by incorporating sdoh into preventing the spread of disease and to approach patient care in a holistic manner, the unfair differences can be minimized socially and economically. ss designed and drafted/wrote the manuscript. aa referencing and edited the manuscript. kc edited the manuscript. sb designed and edited/wrote the manuscript. all authors contributed to the article and approved the submitted version. early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (covid- ) during the early outbreak period: a scoping review the epidemiology and pathogenesis of coronavirus disease (covid- ) outbreak people who need to take extra precautions preliminary estimates of the prevalence of selected underlying health conditions among patients with coronavirus disease -united states covid- ): people who are at higher risk for severe illness associations between perceived stress, socioeconomic status, and health-risk behaviour in deprived neighbourhoods in denmark: a cross-sectional study the social determinants of health, health equity, and human rights why schools in rich areas get more funding than poor areas intergenerational transmission of neighbourhood poverty: an analysis of neighbourhood histories of individuals healthy people available online at % with likely covid- to avoid care due to cost. well being ( ) healthy people association between living in food deserts and cardiovascular risk socioeconomic inequalities in cardiovascular disease mortality; an international study food insecurity, ckd, and subsequent esrd in us adults dietary acid load: mechanisms and evidence of its health repercussions higher dietary acid load potentially increases serum triglyceride and obesity prevalence in adults: an updated systematic review and meta-analysis food swamps predict obesity rates better than food deserts in the united states obesity hypoventilation syndrome covid- in critically ill patients in the seattle region -case series factors associated with hospitalization and critical illness among , patients with covid- disease in new york city. medrxiv high prevalence of obesity in severe acute respiratory syndrome coronavirus- (sars-cov- ) requiring invasive mechanical ventilation for blacks in america, the gap in neighborhood poverty has declined faster than segregation hispanics hit harder by the coronavirus, early u.s. data show how to save black and hispanic lives in a pandemic the color of coronavirus: covid- deaths by race and ethnicity in the social capital, income inequality, and mortality hostility, social support, and carotid artery atherosclerosis in the national heart, lung, and blood institute family heart study acculturation stress, social support, and self-rated health among latinos in california access to foods that support healthy eating patterns how air pollution exacerbates covid- exposure to air pollution and covid- mortality in the united states: a nationwide cross-sectional study. medrxiv quality of housing the role of housing type and housing quality in urban children with asthma high school graduation language and literacy new effort aims to provide covid- resources to non-english speakers in u healthy people coronavirus economic stimulus payments: who gets it, how, & impact on other benefits the new york times. stocks rise, with tech index now up for financial and health impacts of covid- vary widely by race and ethnicity intersecting u.s. epidemics: covid- and lack of health insurance prevention of mother-to-child transmission services as a gateway to family-based human immunodeficiency virus care and treatment in resource-limited settings: rationale and international experiences what your next stimulus "check" really might look like available online at idaho coronavirus map and case count the atlanta journal-constitution governor little issues stay-at-home order for idaho georgia allowed some businesses to reopen today, but many store and restaurant owners aren't ready to take the risk idaho governor extends stay-home order through april because of coronavirus available online at health inequalities and infectious disease epidemics: a challenge for global health security we thank kabita pandey for help in preparation of figure and douglas meigs for editorial help. the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.copyright © singu, acharya, challagundla and byrareddy. this is an open-access article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- -uftc inx authors: nan title: abstract of th regional congress of the isbt date: - - journal: vox sang doi: . /vox. sha: doc_id: cord_uid: uftc inx nan in the fin de siecle was heavily concentrated in vienna. freud, boltzmann, schr€ odinger and mach might be the first names to find, whenever one cites austrian scientists. but more related to transfusion are the noble prize winners max perutz and karl landsteiner. landsteiner s fate illustrates the brain drain beginning in the early s escalating in with the "anschluss", which lead to the forced emigration of many scientists. a loss which was not regenerated in the post war years and was further aggravated by dubious and often undisclosed relations and scandals in the nazi-era. all together this leads to a severe loss of credibility and productivity of universities across decades. opening university access in the early s and intensive historical work-up of scandals transformed the austrian universities to open and effective scientific institutions driving innovation in the country. austria has achieved a great economic deal in recent decades, which was accelerated by the eu membership in . as a result of strong long-term economic performance, the country's gross domestic product (gdp) per capita is the eighth highest among oecd countries and fourth in the eu . levels of poverty and income inequality are both below the oecd average. investment in research and development (r&d) increased since the eu accession, when austria's r&d intensity (aggregate r&d expenditure as a percentage of gdp) was well below the oecd average and significantly far lower than switzerland -a country to which austria prefers comparison. the eu target of % r&d intensity was first met in and is the sixth highest among oecd countries and the second highest in the eu . austria showed the second highest increase in r&d intensity of all oecd countries, exceeded only by korea. the rapid expansion was matched by a similar increase in human resources and scientific output of universities. austrian science in quantum mechanics, quantum communication and information is world renown. vienna is a major biotech hub, as is linz in mathematics and mechatronics and graz in automotive and production technologies. austria has been a net resource recipient in the horizon and the preceding th framework programme. small and mediumsized enterprises show a high propensity to co-operate with universities and other research organisations and more and more included in scientific grant schemes. vienna is the largest student city in the german-speaking world and consistently ranks among the top cities in the world on quality-of-life indices. as austria possesses globally recognised cultural attractions ranging from famed salzburg festival to the vienna new year concert its inhabitants are not aware of the progress made in r&d and how thriving innovation is going on in their country. they still love to show their cultural heritage and events and impress the world with some kind of eternal sound of music. patients with refractory b-cell malignancies as non-hodgkin lymphomas (nhl) resistant to standard therapies have a dismal prognosis. the outcome is even poorer in patients relapsing after autologous stem cell transplantation. most of these patients do not qualify for an allogeneic hematopoietic cell transplantation (hct) due to refractory disease, lack of a suitable allogeneic donor, higher age or cumulative toxicity of previous chemotherapy. despite patients undergoing allogeneic hct normally profit from a graft-versus -lymphoma effect, overall survival in patients with nhl after hct remains short. a similar situation can be observed for patients with acute lymphoblastic leukemia (all). therefore novel treatment modalities are urgently needed. chimeric antigen receptor (car)-t cells, a new class of cellular immunotherapy involving ex vivo genetic modification of t cells to incorporate an engineered car have been used in clinical trials. in the majority of studies b-cell malignancies treated with cd targeting car-t cells have been analyzed. austria had the advantage to participate in two international trials in the past and is currently involved in further car-t studies. recently, results from cd directed car-t cell trials with an increased follow-up of patients led to fda (food and drug administration) and ema (european medicines agency) approval of tisagenlecleucel and axicabtagene ciloleucel. common adverse events (aes) include cytokine release syndrome and neurological toxicity, which may require admission to an intensive care unit, b cell aplasia and hemophagocytic lymphohistiocytosis. these aes are manageable when treated by an appropriately trained team following established algorithm. in this presentation, results of four large phase ii cd car-t cell trials for patients with nhl and all and focus on aes is summarized. preoperative anemia is a known risk factor for increased perioperative morbidity and mortality in patients undergoing major surgery. previous studies have not only shown higher in-hospital mortality, but also an increased hospital length of stay, greater postoperative admission rates to intensive care and prolonged use of mechanical ventilation and intensive care resources in patients with anemia compared to those with normal preoperative hemoglobin concentrations. about % of patients scheduled for major surgery suffer from preoperative anemia. this figure is even higher in patients requiring orthotopic liver transplantation, where up to % of all patients are diagnosed with anemia prior to surgery. transfusion of packed red blood cells (prbcs) is commonly used to correct anemic hemoglobin values. however, transfusion of prbcs has been associated with increased morbidity and mortality in patients undergoing cardiac, orthopedic, and abdominal surgery. additionally, transfusion of prbcs is associated with a greater incidence of postoperative acute kidney injury in patients undergoing orthotopic liver transplantation. as preoperative anemia might increase the perioperative use of prbcs, negative effects observed after prbc transfusions might even be augmented. data on the influence of preoperative anemia on morbidity and mortality after orthotopic liver transplantation are limited. thus, we retrospectively analyzed the association of preoperative anemia and mortality in adult patients undergoing orthotopic liver transplantation at our institution. in addition, we examined the influence of anemia on perioperative parameters such as transfusion requirements, surgical complications, early allograft dysfunction, acute kidney injury, and the need for renal replacement therapy. based on the results obtained in the retrospective analysis, an ongoing prospective randomized clinical trial was initiated. the two suspensive treatments in sickle cell disease (scd) are hydroxycarbamide, inducing the production of the functional hbf, normally repressed at birth, and red blood cell (rbc) transfusion, a critical component of scd management. however, rbc transfusion is not without risk. repeat exposure to allogeneic rbcs can result in the development of rbc alloantibodies which can make it difficult to find compatible rbcs for future transfusions. however, the main concern of alloimmunization is the development of hemolytic transfusion reaction, with in the most severe cases, hyperhemolysis, leading to multi organ failure and death in % of the cases. the prevention of this life threatening condition must be based on risk factors. however, although some risk factors, such as alloimmunization, have been identified, much of the mechanism underlying dhtr remains a mystery, particularly in severe cases presenting hyperhemolysis. here we will describe the current and future development to prevent and treat this severe syndrome in order to decrease exposure to transfusion in scd but also improve red blood cell quality, some new products are developed. oxidative damage is one of the parameter that could be diminished. some work is also ongoing to prevent filter blockage during leucodepletion of precious rbcs units from afro-caribbean donors carrying the sickle cell trait. finally, in countries with higher risks of transmission of infectious disease, treatment of red blood cell units against infectious agents can be discussed. the only current curative treatment of scd is hematopoietic stem cell transplantation (hcs). however, the occurrence, frequency, and effects of immune hematologic complications in hcs remain and will be discussed. finally, gene therapy is a real hope as a definitive curative treatment. clinical trials are ongoing in france and will be discussed as well as the remaining place of transfusion in this therapeutic. in the context of the chronic myeloid leukemia (cml), we have hypothesized that quiescent leukemic hematopoietic stem cells (hsc) compartment, escaping to the current tyrosine kinase inhibitors (tkis) treatment, in part associated in the molecular relapse, may be targeted by cart-cells immunotherapy. gene expression profiling studies have established that a cell surface biomarker il- rap is expressed by the leukemic but not by the normal cd + /cd -hsc. this talk will focus of the whole process of development of a cart-cells starting from recombinant il- rap protein mice immunization to produce a specific monoclonal antibody (mab), to the proof of concept demonstration, before moving into the clinic. we produced and selected a specific anti-il- rap mab (#a c clone, diaclone sa, besanc ßon, france). after molecular characterization of antigen-binding domain, nucleotide sequences were fused with rd generation t cell activation coding sequences and cloned as a single chain into a lentiviral backbone comprising a safety switch suicide gene icasp (inducible caspase ) and a monitoring/selection cell surface marker Δcd . we demonstrated in-vitro and in an in-vivo xenograft murine model that il- rap car t cells can be activated in the presence of il- rap+ cell lines or primary cml cells, secrete pro-inflammatory cytokines, degranulate and specifically killing them. we also demonstrated that multi-tkis treatment over a -year period does not affect transduction efficiency of cml patient t-cells by il- rap car vector and that autologous cart-cells are able to target il- rap+ leukemic primary hsc. "off-tumor-on target" toxicity prediction, by studying il- rap expression on a tissue macroarray comprising normal human tissues ( donors) , with #a c , detected various il- rap intensity staining in only few tissues. regarding the healthy hematopoietic system, #a c flow cytometry staining did not detect hematopoietic cells, except monocytes that express poorly il- rap. as expected, monocyte subpopulation is targeted by autologous il- rap cart cells (ratio e: t = : ), but at a lower level that il- rap cml cell line. in-vivo investigation of specific toxicities of autologous il- rap cart-cells against hsc and/or immune cells on a human-cd + cord blood cell engrafted/nog murine model, but also by an in-vitro cd + colony forming unit assay didn't reveal any significant toxicities in immunocompetent cell subpopulations, suggesting that healthy cd + hsc are not affected. finally, to overcome potential toxicity, functionality of the icasp / rimiducid â safety switch was demonstrated in-vitro but also in-vivo in a nsg tumor xenograft model, showing that, when activate, the system is able to eliminate more than % of cart-cells, after exposure to ap . in conclusion, based on cml model, we demonstrated that il- rap is an interesting target for cart-cell immunotherapy, with a limited "on target, off tumor" predictable toxicity. next step will be the up-scaling of the process in order to match with the use in human regarding also the regulatory requirements. this strategy may be applied, in the future, in other hematological malignancies. mortality ranges from to % for trauma victims with severe bleeding and is largely dependent on the transfusion therapy from which they can benefit. the nature of this therapy has an impact on prognosis with a halving of mortality when the plasma/prbc ratio is greater than ½ and a decrease of about % when the proportion of platelets transfused is close to that of whole blood. the speed with which such therapy is actually administered has a major impact as well with an increase in mortality of % for each minute of delay in making the entire therapy available. this can be explained mainly by the fact that the probability of death of these patients is greater within minutes of their admission to hospital with a median time to death of h after admission. to allow plasma, platelets and prbc to be made available in a timely manner, north american trauma centers have mandated that trauma centers have massive transfusion packs at the patient's bedside within min. to further simplify and speed up logistics from distribution to transfusion, several trauma centers now use whole blood stored at °c. this return of an "old" product is largely inspired by military experience where whole blood is mainly used "warm" immediately after collection with compelling evidence of its effectiveness. its return to civilian practice requires the ability to deleukocyte it while preserving platelets and to store it while maintaining their hemostatic functions. good quality data shows this is achievable and several clinical studies are planned to begin in the coming months. in france, the french blood establishment and the french army are cooperating to initiate the prospective randomized non-inferiority storhm trial (sang total pour la r eanimation des h emorragies massives) which will be comparing whole blood to separate blood components in an / / ratio in severely bleeding trauma patients. the primary endpoint will be a thromboelastographic parameter (maximum amplitude) assessed at the th hour after admission. secondary endpoints will include early and overall mortality, lactate clearance (reflection of the effectiveness of resuscitation) and h organ failure. this trial will be recruiting patients in french trauma centers and is planned to be initiated second half of . local/neighbours day: innovation in germany c- - mesenchymal stromal cells for regenerative therapy bm-msc / asc obtained from these protocols have been characterized in detail in preclinical evaluations. manufacturing licenses for msc and asc and a platelet-derived growth factor concentrate have been obtained and they have been explored in several clinical trials for treatment of bone defects (ortho-ct : eudract number: - - ; ortho-ct : eudract number: - - ; maxillo : eudract number: - - ) . we will summarize results of completed clinical trials which confirmed feasibility and safety of autologous msc /asc treatment and provided evidence for efficacy (gjerde et al, stem cell res. introduction: in vitro produced megakaryocytes (mks) may serve as source to produce platelets (plts) ex vivo or in vivo. we have established a strategy to differentiate mks from induced pluripotent stem cells (ipscs) in bioreactors. this study aimed at the large-scale production of mks using microcarriers to increase the mk yield and to characterize their phenotype and functionality after irradiation as a method to decrease possible safety concerns associated to the ipsc origin. methods: ipscs were cultured in an aggregate form in presence or absence of microcarriers using ml stirred flasks. cells were differentiated into mks using tpo, scf and il- in apel medium for a period of days. non-irradiated or irradiated ipsc-derived mks were analysed for polyploidy, phenotype and proplt production using flow cytometry and fluorescence microscopy. also, plt-production was investigated in vivo. non-irradiated or irradiated mks were transfused to nod/ scid/il- rcc-/-mice and blood was analyzed for human plts. results: differentiation of mks in presence of microcarriers resulted in an -fold increase of mks per ipsc in comparison to only aggregates. this resulted in mean of total mk harvest of . ae . in microcarrier-assisted bioreactors in comparison to . ae . mks collected from bioreactors containing only aggregates. interestingly, mks produced in microcarrier-assisted bioreactors showed higher proplt formation capacity than mks derived from only aggregates bioreactors. mk phenotype and dna content was comparable between mks derived from both types of bioreactors. irradiation of mks did not affect their phenotype and capability to form proplts or plts after transfusion into nod/scid/il- rcc -/mice. conclusion: microcarriers showed to significantly increase the yield of ipsc-derived mks in stirred bioreactors to clinically relevant numbers. this may facilitate the use of ipsc-derived mk for ex vivo production of plts, direct transfusion or for innovative mk-based regenerative therapies. although the rosetta stone, found by the troops of napoleon in egypt near the city of rosetta (rashid) contains only a small amount of text in three languages it was key in deciphering hieroglyphs. the rosetta mission tried to achieve something similar: by looking at a tiny body its goal was to decipher the origin of the solar system, planets including earth and life. after more than years the rosetta spacecraft softly crashlanded on comet churyumov-gerasimenko on september , . it has travelled billions of kilometers, just to study a small ( km diameter), black boulder named p/ churyumov-gerasimenko. the results of this mission now seem to fully justify the time and money spent in the last decades on this endeavor. where are we from? where are we going? are we alone in the universe? these are some of the big questions. in this talk i will show which answers we got from rosetta and comet chury. we follow the pathway of the material which makes up our solar system from a dark cloud to the solar nebula and finally to planets and life. i will show that indeed we are the result of stardust and that what happened here may happen elsewhere in the universe. cells, tissues and entire organs can collectively be seen as "living drugs". genetically unaltered cells are routinely used in clinical practice to treat diseases as diverse as anemia, bleeding disorders, leukemia and organ failure. ground-breaking advances in genetic and genome engineering technologies are propelling cell therapies to the frontline of medical research and practice. the hematopoietic system is particularly amenable to genetic engineering because specific cell types can be purified based on the expression of specific surface proteins and the ability to culture and expand cells ex vivo. the recent unprecedented clinical success of killer t cells reprogrammed by chimeric antigen receptors (cars) to attack cd expressing tumor cells demonstrates the power of immunotherapy with genetically engineered immune cells. however, given the rapid development of novel genome engineering and synthetic biology tools we are likely only at the beginning of a new era of engineered cellular therapies. i will present recent progress in immune cell reprogramming, gene correction, safety aspects and remaining challenges such as manufacturing. d- - cell free nucleic acids (cfna) circulate in the plasma of all individuals and are thought to be released by host and foreign cells into the circulation. after fractionation by centrifugation, cfnas can be extracted from the supernatant of whole blood samples or manufactured blood products. these dna or rna sequences can be of human, bacterial, viral or fungal origin. most of them are human double stranded dnas. research on cfnas is increasing, thanks to technological advancements in molecular biology. some of their results are already implemented in clinical practice in the areas of prenatal diagnosis, oncology and infectious diseases. the latter investigation focuses on the exploration of non-human cfnas, the field of metagenomics. high throughput sequencing associated with bioinformatics, the so-called new generation sequencing (ngs), has sped up the investigations of non-human cfnas. this tool provides the opportunity to classify cfnas into a human or non-human category, and then to identify them. it is thus possible to explore simultaneously the whole landscape of bacterial, viral and fungal populations. presently, ngs of human blood has already proven its feasibility and its value in identifying emerging viruses or investigating clinical cases of fever of unknown etiology. ngs of cfnas is also particularly effective in analyzing the different genotypes of a virus in case of a co-infection (e.g. hepatitis c virus). studying cfnas with the new molecular technologies is therefore of great importance in transfusion medicine, especially regarding security and clinical transfusion reactions. first, transfusion transmitted infections are the most feared adverse complications. second, febrile non-hemolytic transfusion reactions are also the most frequently reported adverse events in hemovigilance systems and their physiological mechanism -if only one-remains not clearly elucidated. investigating cfnas could thus improve our understanding and strategy aiming at reducing those two clinical adverse events. surveying comprehensively the composition of circulating infectious agents in a blood product by ngs technology could be very interesting for investigating a severe febrile transfusion reaction. moreover, when the costs of analysis will be reduced, it might be possible to screen prospectively and regularly the whole metagenomics of asymptomatic blood donors, in addition to the classical epidemiological surveillance. for instance, in a study testing a ngs method on manufactured fresh frozen plasmas, an astrovirus (mlb ) has been identified. finally, it is the responsibility of transfusion physicians implicated in the manufacturing of blood products to ensure that cfnas within a blood product do not have a clinical impact on the innate immunity of the recipients. according to recent research in vitro, cfnas purified from blood products can induce the transcription of inflammatory cytokines by mononuclear cells. as nonhuman cfna have an effect on toll-like receptors (tlr-linked inflammatory pathways), it would be also relevant to insure that donor's cfnas have no significant effect on the immune system of the recipient. in conclusion, cfnas are very diverse molecules contaminating blood products. technological progress makes now their investigation more available. besides being useful markers of infection in asymptomatic donors, their impact on the recipients' immunity should be further investigated. an active life and regular training is part of a healthy life style and for many this includes participation in endurance exercise competition at different levels. thus, it is highly relevant to know how a blood donation affects exercise performance and how close this can done to an endurance competition. endurance exercise performance is determined by many factors, but three of the primary are maximal oxygen uptake, the relative load that an individual can sustain over time and finally the efficiency of movement in the given discipline. over the years, a number of studies have sampled blood volumes ranging from - ml and applied different methodological approaches to measure maximal oxygen uptake over a recovery period ranging between - days. overall, the general finding is a reduction in blood haemoglobin and an attenuated maximal oxygen uptake as well endurance performance after blood donation. in normal to well-trained men maximal oxygen uptake and performance was normalized after two weeks in one study after a normal blood donation ( / ml), but remained attenuated after four weeks in another study, despite the change in blood haemoglobin concentration was similar and the design and methodology also similar in the two studies. in addition to maximal oxygen uptake the relative load that can be tolerated during exercise is probably also attenuated, through a decreased arterio-venous oxygen extraction, but the available data is very limited. the first part of this talk will highlight the major findings and discuss some of the methodological issues that complicate interpretation and conclusions. there are sex differences in circulating blood volume, haemoglobin concentration, haematocrit and hormone levels and thus it is entirely possible that there is a sex difference in the effect of blood donation on physical performance and the recovery after blood donation. in addition to the basic physiological sex differences, there is also a higher prevalence of iron deficiency in premenopausal women, physically active women and women donating blood. therefore, we studied the influence of a standard ml blood donation on maximal oxygen uptake and endurance performance and the subsequent recovery in physically active women. we observed that in iron sufficient women blood haemoglobin concentration and maximal oxygen uptake were back to baseline days after blood donation, but endurance performance was normalized already after days. the second part of this talk will discuss the sex differences in the effect of blood donation on maximal oxygen uptake and endurance performance. overall, the available data suggest that, with a careful conservative approach, - weeks are needed after a normal blood donation to be fully recovered to participate in endurance exercise competitions. more than one in ten attempts to donate blood result in a temporary deferral, due to concerns about the impact of the donation on the donor or recipient. there is well established evidence that temporary deferrals impact negatively on donors, with a large proportion of those deferred failing to return at the end of the deferral period. this presentation provides an overview of deferrals from the donor perspective, describing the likelihood of receiving a deferral for different donor subgroups. the impact of temporary deferrals on the future donation of donors, considering both short-term and longer-term donation patterns, will also be reviewed, outlining which donors are at highest risk of non-return following a deferral, and what is known about the accumulative impact of multiple deferrals on donors. several hypotheses have been proposed to account for the strong negative impact of deferrals on donor behaviour, and there is preliminary evidence of psychological factors, such as emotional reactions, predicting intention to return. research is also beginning to emerge on the effectiveness of tailored interventions to mitigate the impact of deferrals on donor behaviour. the evidence for these preventative interventions, and for strategies to reactive donors once they have lapsed post-deferral, will be reviewed. recommendations for blood centres will be made, as well as suggestions for future research to address continuing gaps in knowledge. in his influential study "the gift relationship" ( ) , richard titmuss coined the idea of voluntary, non-paid, blood donation being the gift of life for a fellow citizen. this metaphor has been powerful in mobilizing donors (busby ) . it conveys a direct relationship between blood donation and patients' vitality, as well as a difference between gains and costs. as the gift of life, blood donation is seen to symbolize pure altruism and promoting solidarity between strangers. but can we apply the metaphor as successfully into donating blood for research? we asked a group of finnish blood donors what they would think if the frc blood service invited them to give a blood sample and personal information for research. the blood donors were usually willing to contribute to research for the public benefit, because they saw great potential in science to create solutions to help patients in the future. however, based on our interview data and previous research, we suggest that the analogy between gift of life and donation for research did not work all the way. the metaphor fails to address donors' questions on new types of relationships, interests and risks related to the use of personal data for research. left unanswered these could discourage donating for research. hence, we argue that the gift of life metaphor is not applicable to donor recruitment at the research context. in this presentation we wish to look for a better metaphor for donation for research that blood services collecting research data could apply. academy day: transfusion challenges in patients with sickle cell disease a- - immunohaematological features of patients with sickle cell disease (lfa) should be considered as polymorphic antigens in the african population and these lfa are not present in most commercial panels. the situation is even more complicated when recipients lack high-frequency antigens, the most common ones being hr-, hr b -, sec-, u neg , u+ var , js(b-), (hy-), and jo(a-). finally, there is a high rh diversity among people of african descent. because they harbor variant alleles and/or partial rh antigens, they are at risk of developing alloantibodies. in this setting, screening for partial rh antigens makes sense. the figures illustrating this diversity vary with the approach used. one of them is to take into consideration rhd or rhce*ce variant alleles. in several american studies, their prevalence was estimated to be - % and - %, respectively. other teams take into consideration d, c and e partial antigens. their prevalence was estimated to be . - %, . - . %, . - . %, respectively, and the alloimmunization rates were . %, . - %, . %, respectively. as a result of these phenotype discrepancies, scd patients are more likely to be alloimmunized. an overall immunization rate of - % is commonly admitted in the general population. depending on the unit selection policy and/or the study design, the immunization rate in scd patients varies from % to %, the highest figures being established when an abo/rh -only matching policy is implemented. in a meta-analysis of publications, the overall alloimmunization rates were around %. alloimmunization is thought to be enhanced by an inflammatory state, which is often present in scd patients. they are more prone to develop a new alloantibody. using a stochastic modeling of alloimmunization, they have a % increased risk of producing additional antibodies versus % in the general population. autoantibodies have been identified as a risk factor of alloimmunization. as a result, scd patients often have complex mixtures of allo and autoantibodies. rh antibodies and those considered as irregular natural antibodies are present in a significant proportion. another characteristic of the antibodies in scd patients is their evanescence; up to % of alloantibodies become undetectable within a few years of their initial development. relatedly, about a third of dhtrs are reported to happen in patients with no previous history of immunization. in addition, a third of patients will not develop an antibody after a dhtr. identifying patients at risk of developing a dhtr is key to managing them properly. alloimmunization is a serious risk of red blood cell transfusion in patients with sickle cell disease (scd) and can result in severe (delayed) haemolytic transfusion reactions, exacerbation of clinical symptoms and life-threatening hyperhaemolysis. once alloimmunized, the presence of alloantibodies in the patients' blood further complicates pretransfusion testing and hampers the selection of compatible blood products. numerous studies have shown that scd patients have a relatively high risk of alloimmunization as compared to the 'general' population. this is not only explained by the large number of transfusions given but also by the increased exposure to foreign antigens as a result of differences in the antigen make-up of the scd recipients and the blood donor population. other factors involved in the immune response such as age at first transfusion, inflammatory state, hla typing are under investigation and are starting to unravel. because blood transfusion is still one of the main treatment modalities for scd and some patients have a life-long transfusion dependency it is important to minimize the alloimmunization rate. theoretically, complete matching for all relevant blood group antigens would prevent alloimmunization. this however, is only possible when all donors are comprehensively. matching strategies should be developed to minimize alloimmunization while balancing patients' need and donor availability and is cost effective. to develop a (preventive) matching strategy some factors need to be established; ) which antibody specificities are clinically relevant ) which antigens are most immunogenic ) what is the availability of specific antigen typings in the donor population ) how should recipients (and donors) be typed, phenotypically and/or genotypically and to what extent. the latter is especially important in scd patients since they are of african descent and the prevalence of genetic variations in this population is relatively high. rhd and rhce variants are common and can remain undetected when serological typing is used but can be discovered with high resolution molecular typing. patients with partial rh phenotypes are at risk for alloimmunization. apart from special rh phenotypes in individuals from african descent, the fy(a-b-) phenotype related to the gata-box mutation in the fyb allele and the u-or u var phenotype resulting from genetic variations in the mns alleles are also common. several studies have shown that in scd patients antibodies directed against rhd, rhe, rhc and k are most frequently found when unmatched transfusions are given. preventive matching for these antigens has proven successful in reducing alloimmunisation. extended matching for all rh antigens fy(a), jk(a) and jk(b) can further decrease the alloimmunisation rate. currently, different countries have preventive matching strategies in place for this vulnerable patient group. as genotyping is more and more available and within reach, optimal antigen typing approaches for patients and donors, combining serology and genetics are being developed. in this lecture several aspects of antigen typing approaches and preventive matching strategies that will most benefit scd patients of will be discussed. artificial intelligence has become a buzzword that will appear about anywhere in the media. we can forget that ai, or the subfield in this computer science field machine learning, has been around for over years. improvements in computing power, abundance of data, progress in computer science, and the arrival of affordable cloud solutions have now brought it to our daily lives. also in health care news about ai has become omnipresent. and some landmark papers have come out on algorithms outperforming (teams of) physicians in the diagnosis of all kinds of skin disease, eye disease from retina scans, and detect cancer in ct scans. however, little of these solutions have actually shown up in our clinical practice yet. in anaesthesia, we worked with the first algorithm to come to anaesthesia practice; hypotension during surgery is associated strongly with poor outcome like myocardial ischemia, surgical complications, renal failure and even mortality. we worked on a machine-learning trained algorithm that predicts hypotensive events using the arterial blood pressure curve up to - min before the actual event. to get fda and ce approval, however, mere mathematic validation is required. this can be achieved on retrospective datasets. in reality, we need more before we can use these algorithms to support our decision-making; after internal (retrospective) and external (prospective but passive use) validation steps, clinical (i.e. rct validation is needed. moreover, we will need to assess the economic impact too. ultimately this tool has now reached clinical practice and is starting to help us go from reactive to more proactive hemodynamic management. like this, we have started to work on machine-learning tools to predict the incidence of specific types of patients coming into a&e and predicting infections after surgery. we will discuss our approach, essentials to start with machine learning, practical learnings. we will also discuss a first project design to use machine learning in managing bleeding patients to get the best therapy advice for blood product use like plasma, fibrinogen et cetera. how can we start using this tool in unison with our existing tools to improve science and clinical practice in our respective (bio)medical fields? thrombocytopenia is a very common hematological abnormality found in newborns, especially in preterm neonates. two subgroups can be distinguished: early thrombocytopenia, occurring within the first h of life, and late thrombocytopenia, occurring after the first h of life. early thrombocytopenia is associated with intrauterine growth restriction, whereas late thrombocytopenia is caused mainly by sepsis and necrotizing enterocolitis. platelet transfusions are the hallmark of the treatment of neonatal thrombocytopenia. most of these transfusions are prophylactic, which means they are given in the absence of bleeding. however, the efficacy of these transfusions in preventing bleeding has never been proven. in addition, risks of platelet transfusion seem to be more pronounced in preterm neonates. because of lack of data, platelet transfusion guidelines differ widely between countries. in a recent randomized controlled trial (planet- /matisse study) among preterm infants with severe thrombocytopenia, we found that those randomly assigned to receive platelet transfusions at a platelet-count threshold of /l had a significantly higher rate of death or major bleeding within days after randomization than those who received platelet transfusions at a platelet-count threshold of /l. this presentation summarizes the current understanding of etiology and management of neonatal thrombocytopenia. transfusion-associated circulatory overload (taco) is a severe transfusion adverse reaction that is associated with increased mortality and morbidity. the incidence of taco in adults varies from % to %, but is probably underdiagnosed and underreported. the incidence in the pediatric population is undetermined. taco usually occurs in patients who receive a large volume of blood product over a short period of time. it is more common in patients with known risk factors such as cardiovascular disease, renal failure, and older or younger age (> years or < years). hospitalised patients and intensive care patients are also more at risk. the typical presentation of taco is respiratory distress (dyspnea, tachypnea) occurring within h of a blood transfusion. associated signs and symptoms are hypoxia, hypertension, tachycardia, positive fluid balance, high central venous pressure, and acute or worsening pulmonary edema on chest x-ray. echocardiography and measurement of brain natriuretic peptide (bnp) or its n-terminal prohormone (nt-probnp) is helpful for diagnosis. several definition criteria have been proposed for taco, but none are adapted for children, particularly critically-ill children who are more at risk. this is probably the main reason why taco is even more underdiagnosed and underreported in the pediatric population. in a recent study, we compared the incidence of taco in a pediatric intensive care unit using the international society of blood transfusion (isbt) criteria, with two different ways of defining abnormal values: ) using normal pediatric values published in the nelson textbook of pediatrics; and ) using patients as their own controls and comparing pre-and post-transfusion values with either a % or % difference threshold. we monitored for taco up to h post-transfusion. a total of patients were included. taco incidence varied from . % to %, depending on the definition used. with such wide variability, we conclude that a more operational definition of taco is needed in pediatrics, particularly for critically-ill children. differential diagnosis from other dyspnea-associated transfusion adverse reactions (e.g. transfusion-associated lung injury, anaphylaxis) is important because treatment differs, as do guidelines to the blood bank. treatment for taco is similar to that of any other cardiogenic pulmonary edema: oxygen, diuresis, ventilatory support. prevention is possible by avoiding unnecessary transfusions, transfusing only the necessary amount of blood product, avoiding rapid transfusions, and using diuretics. background: the risk and importance of transfusion-transmitted hepatitis e virus (tt-hev) infections by contaminated blood is currently a controversial discussed topic in transfusion medicine. in particular, the infectious dose is a not finally determined quantity. the different countries have chosen different approaches to deal with this pathogen. one central question is the need of individual nat screening (id) versus minipool nat screening (mp) approaches to identify all relevant viremias in blood donors. aims: comparison and evaluation of the available screening strategies in relation to the infectious dose to minimize the risk of tt-hev infections. methods: we systematically reviewed the presently known cases of tt-hev infections and available routine nat-screening assays. furthermore, blood donation screening strategies for hev ehev in effect in the european union were compared. we also describe our own experiences of hev screening utilising an id-nat-based donor screening algorithm compared to mp-nat in pools of samples. from november to january , a total of , blood donations were screened for the presence of hev rna using a mp-nat (in house, realstar hev rt-pcr kit) and an id-nat (cobas platform). results: the review of the literature revealed a significant variation regarding the infectious dose causing hepatitis e. in the systematic case review, all components with a viral load (vl) greater than . e+ iu caused infection (definitive infectious dose (difd) . the lowest infectious dose resulting in tt-hev infection observed in general was . e+ iu (minimal infectious dose (mifd). the infectious dose of the different blood products is mainly influenced by the remaining plasma content. our data comparing the two different hev screening algorithms revealed eight hev rna positive donations using a mp-nat (incidence : , ) , whereas hev rna positive donations were identified by id-nat (incidence : ); all id-nat only positive donations had vl < iu/ml. summary/conclusions: taken into account the current knowledge on the required mifd, the difd, and the analytical sensitivities of the screening methods, we extrapolated the detection probability of hev-rna positive blood donors using different test strategies (nat assay, id vs. minipool with different pool sizes). we also considered the amount of plasma in the different blood products and calculated the infectious doses needed to be detected. only id testing would be sufficient to detect the minimum vl in the donor to avoid tt-hev infections based on the currently known mifd, but a highly sensitive mp-nat should be adequate as a routine screening assay to identify high viremic donors and avoid tt-hev infections based on the difd. we have also determined that the incidence of hev infection was approximately % higher if id-nat was used. however, vl were below iu/ml and will most likely not result in tt-hev infection taken into account the currently known mifd or difd. the clinical relevance of and need of identification of these low level hev positive donors still require further investigation. in the last years several pathogen inactivation (pi) technologies have been developed to be applied to blood components. technologies for inactivating pathogens in plasma and platelets are available in the european union, and some others are currently under development. the first pi technology introduced in the market was for plasma, and was based on the addition of methylene blue and the illumination with light (theraflex mb-plasma, macopharma and gr ıfols). for platelets and plasma two technologies are licensed, one is based on the addition of amotosalen and the illumination with ultraviolet light (uv) (intercept â , cerus) and the other one combines the addition of riboflavin (vitamin b ) and the illumination with uv light (mirasol â , terumo bct). currently another technology for platelet inactivation, based on the illumination with uvc light and strong agitation is under development (theraflex, macopharma). for red blood cells one technology based on the addition of one molecule (amustaline, cerus) is being developed. the mechanism of action, and the spectrum and level of inactivation of pathogens varies among the different technologies. in addition, the number of studies with clinically relevant endpoints and the number of patients included in the studies is not homogeneous. there is published evidence for most of them that show that the treated blood components are safe and efficacious for the patients although, for treated platelet concentrates some decrease in the posttransfusion recovery and survival of the transfused platelets occur, with differences between the different technologies. however, cumulative experience on the use in routine, for some of the technologies for almost years, support the concept of the safety and efficacy of the blood components treated with pathogen inactivation technologies without a significant increase in utilization. the use of pathogen inactivation for blood components is not widespread. differences in epidemiology between countries, infectious risk perception, concerns about potential adverse effects associated with its use and economical considerations might explain the differences observed in its implementation. the history of the p and p k antigens is complicated and sometimes confusing because of several changes to the nomenclature. the association between the antigens and their genetic home has raised many questions as well as the longstanding enigma regarding the molecular mechanism underlying the common p and p phenotypes. the system (isbt no. ) currently includes three different antigens, p , p k and nor. the p antigen was discovered already in by landsteiner and levine while p k and nor were described in and , respectively. as for the abo system, naturally-occurring antibodies of igm and/or igg classes can be formed against the missing p /p k carbohydrate structures. anti-p is usually a weak and cold-reactive antibody very rarely implicated in hemolytic transfusion reaction (htr) or hemolytic disease of the fetus and newborn (hdfn). however, some antibodies against p have been reported to react at °c, bind complement and cause both immediate and delayed htrs. the p k antibodies can cause htr and anti-nor is regarded as a polyagglutinin with unknown clinical significance. a higher frequency of miscarriage is seen in women with the rare phenotypes p and p k /p k . the rbc of the fetus as well as of the newborn express low amounts of p , p and p k antigens but the placenta shows high expression and is consequently a possible target of the antibodies and the cause of the miscarriages. the p k and p antigens have wide tissue distributions and can act as host receptors for various pathogens and toxins. furthermore, altered expression of p k antigen has been described in several cancer forms. a longstanding question has been why individuals with p phenotype not only lack p k and p expression but also p . recently it was clarified that the same a galtencoded galactosyltransferase synthesizes both the p , p k and nor antigens and in addition the p and p phenotypes was confirmed to be caused by transcriptional regulation. transcription factors bind selectively to the p allele in the '-regulatory region of a galt, which enhance transcription of the gene. it has been debated whether the p k and p antigens exist on glycoproteins in the human rbc membrane or if glycolipids are the only membrane components carrying these epitopes. a recent publication shows that the p antigen can be detected on human rbc glycoproteins and thus glycosphingolipids can no longer be considered as the sole carriers of the antigens. the blood group system which started out with one antigen, p , has now gained two more members namely p k and nor. step by step the biochemical and genetic basis underlying the antigens expressed in this system has been revealed but still many questions remain to be solved. neither gata nor klf represent a blood group system but mutations in the genes encoding these transcription factors (tfs) have been shown to result in simultaneous altered expression of blood group antigens in certain rare blood group phenotypes. in particular, mutations in the klf gene are responsible for the dominantly inherited in(lu) phenotype, commonly referred to as lu(a-b-) because of the gross reduction in lutheran antigens expression. red cells from in(lu) individuals, though, have also weakened expression of other blood group antigens, like the high-incidence antigen anwj, the antigens of the indian blood group system (cd ) and p , among others. since the first description of klf variants associated with the in(lu) phenotype, many other variants of this gene have been reported with an impact on blood group antigen expression and they are listed on the klf table of blood group alleles. other than klf , a mutated gata gene has also been found associated with the x-linked form of the lutheran-mod phenotype and has likewise been registered in the gata allele table. besides the effect of tf variants on blood group antigen expression, there are transcription factor-binding site polymorphisms in regulatory regions of blood group genes, which also have an impact on the expression of the encoded antigens in red cells. the first example of such type of polymorphisms was described in , when the disruption of a gata motif in the ackr gene promoter was found to abolish erythroid gene expression in fy(a-b-) individuals of african descent. the impact of mutations affecting gata binding sites has also been described in some abo subgroups, like the am and bm phenotypes. a regulatory element with gata binding sites in the first intron of the abo gene has been found to be altered in individuals with these phenotypes, either by deletion or by a point mutation disrupting the gata motif. recent findings have also revealed that xga expression on red cells is dependent on gata binding to a control element located . kb upstream of the xg gene. a single nucleotide polymorphism (snp) within this region was shown to correlate very well with the expected distribution of the xga negative phenotype in different populations. further work has demonstrated that this g>c snp disrupts a gata binding site and consequently abolishes erythrocyte xg expression. overall, these investigations have allowed to elucidate the underlying genetic basis for xga expression and have made xga genotyping possible. similar to xga, the p antigen has been known for a long time to be determined by the a galt gene but the molecular basis underlying the common p /p phenotypes has remained elusive till recently. several cis-regulatory snps had been identified in non-coding sequences around exon a, which showed a very good correlation with p antigen expression. interestingly, potential binding sites for several hematopoietic tfs were identified in the same region. finally, recent investigations have demonstrated the role of the runx tf in the expression of p antigen, by selective binding to a regulatory site present in p but not in p alleles. to summarize, variation in blood group antigen expression may result from mutations or polymorphisms in the regulatory region of blood group genes. recent reports have unravelled the molecular mechanisms underlying the expression of p and xga blood group antigens, which involves tf binding to allele-specific regulatory elements. similar mechanisms may also regulate antigen expression in other blood group systems. c- - clinical immunology, copenhagen university hospital, copenhagen, denmark since the discovery of cell-free fetal dna (cffdna) in pregnant women's blood, the development of noninvasive prenatal testing (nipt) has provided new diagnostic applications in prenatal care. in transfusion medicine and clinical immunology, cffdna is extracted from maternal plasma to predict fetal blood groups with the purpose of ) guiding targeted rh prophylaxis in non-immunized rhd negative women and ) assessing the risk of hemolytic disease of the fetus and newborn (hdfn) in immunized women. i will give an overview of noninvasive prenatal testing of fetal blood groups. based on the literature, i will summarize the current experience with noninvasive prenatal testing of fetal rhd and other blood groups. for rhd negative pregnant women, routine clinical testing is available in several countries world-wide to assess the risk of hdfn in d immunized women, and routine testing to guide rh prophylaxis is now implemented as nationwide service in - european countries. noninvasive prenatal testing for fetal rhd is highly accurate with sensitivities of . %, as reported from clinical programs. in general, the sensitivity is challenged be low quantities of cffdna, especially in early pregnancy. the specificity is challenged by the polymorphic rh blood group system, where careful attention is needed to navigate among the many rhd variants. rhd variants may complicate cffdna analysis and interpretation of results, especially in populations with mixed ethnicities. despite these challenges, fetal rhd testing is very feasible when implemented with careful attention to these issues. for blood groups that are determined by snps, such as kel or rhc, the main challenge has been interference from the maternal dna when analyzing the fetal dna which has resulted in low accuracy and lower sensitivity, when using qpcr. with the application of more novel techniques such as next generation sequencing and droplet digital pcr, accurate noninvasive prediction of these fetal blood groups has been demonstrated. the success of predicting fetal rhd and its successful clinical implementation into national programs should encourage wide-spread use of cell-free dna based analysis. future work on noninvasive prenatal testing of fetal blood groups determined by snps may consolidate the application for cell-free dna testing for such targets, including human platelet antigens. at isbt, the newly formed cfdna subgroup of the red cell immunogenetics and blood group terminology working party will work to facilitate clinical applications, implementation and evaluation of cell-free dna testing. blood banks in most of the nordic countries all share a vein-to-vein approach which in short means that the collection of blood, the preparation of blood components, testing/release and storing is served by a single actor. on top of that recipient and donor blood grouping, crossmatching, delivery, registration of transfusion and of any complications is usually handled in a single blood banking information system (bbis). this means that blood banks in the nordics are traditionally operated by a single vendor. the needs for process control in a single vendor bbis, the present solutions, unsolved challenges and untapped possibilities of streamlining processes have been scrutinized with the intention to describe separate processes and to acquire best of breed or best of suite it-systems. the aim for integrations, rather than building an integrated it-system, to support the need for a vein-to-vein process is a precondition in the nordic countries. with multiple it-systems supporting isolated processes, we intend to facilitate development in these and furthermore increase the flexibility in the whole process. we set out to reveal any existing knowledge in the literature on it vendor strategies for blood banks, but we didn't succeed in identifying any relevant literature. however, a systematic literature study on vendor strategies when choosing health it was based on the prisma method, and identified studies, but only was eligible for full text review and met the inclusion criteria. even this broader literature study reveals very little evidence. two studies find single vendor strategies poor and conclude "best of suite" solutions to be optimal. one study was not able to correlate vendor strategies to the investigated productivity, but concludes that best of suite and best of breed strategies requires larger organizational changes than a single vendor strategy. in summary, the existing research is contradictory. this paper adds basic knowledge for breaking down the process control of blood banking in smaller processes. this adds the possibility for identifying best of breed or best of suite vendors, instead of relying on single vendor it solutions. furthermore it is a call for more research in the field of vendor selection strategies which this study didn't succeed in identifying. d- - applying drones to supply blood to remote areas: rwanda's experience biomedical services, rwanda-ministry of health-national blood services, kigali, rwanda background: in rwanda, blood transfusion services started in . during the genocide against the tutsis almost all the socioeconomic fabric of rwanda was destroyed as well as its health infrastructure. the healthcare system was suffering in its aftermath, and there were health inequalities between urban and rural areas, including access to blood for transfusion. from , the government started to rebuild all courses of life including the health system and the blood service in particular. the national center for blood transfusion (ncbt) was then mandated to provide safe, effective and adequate blood and blood components to all patients in need. this was pivotal in achieving health related mdgs , and . today, rwanda has an ambitious vision to put all million citizens within minutes of any essential medical product. while every second matters in emergency management, the use of drones was the perfect solution to many of the last mile challenges that have been traditionally difficult to overcome. it is impossible to forecast accurately down to the need of a single patient. the government has provided an easy solution by centralizing supply and providing on-demand, emergency medical deliveries by drone. doctors are now empowered to provide the quality care with all the supplies on hand, patients can now be treated close to home, and we eliminate waste from potential overstocking when health workers know that they have a quick and reliable source of supply. description: in , the government of rwanda started to operate the world's first national drone delivery program for blood and other lifesaving medical products. these drones can carry two to six units of blood at a time and deliver in - minutes depending on a hospital's location. the average duration was between - hours round trip with the vehicle system, before the use of drones. drones currently deliver blood to health facilities throughout the country and are set to reach % of transfusing health facilities outside kigali by the end of the year. within the first year, healthcare workers saved an average of . hours per delivery and a total of , hours of lost time on road pick up they could instead dedicate to patient care. by march , over , deliveries have been made, with % of those being emergency deliveries. a total of more than , blood units have been delivered. in february , zipline obtained the highest rating from the health facilities being served in a performance evaluation conducted by the national center for blood transfusion. when a doctor or medical staffer needs blood, they place an order through the hemovigilance order portal. they are then sent a confirmation message saying a drone is on its way. the drone flies to the health facility at up to km/h. when it is within five minutes of the destination, the medical staffer receives a notification. the drone then drops the package, attached to a parachute, into a special drop zone. conclusion: supply is not a developing country problem, it is a global issue. rwanda was just the first one to recognize the potential of this technology and decided to do something about it first and fast, to ensure access to universal access to all blood products. d- - scottish national blood transfusion service, edinburgh, united kingdom supporting the provision of viable transfusion services in remote/rural areas is more than just a geographical challenge. limited qualified blood bank resource; small throughput volumes; increased regulation are only three of the additional factors combining to threaten safe and sustainable transfusion service delivery. inventory management and out of hours service provision were identified as essential areas where it was thought that technology, in the form of a remotely controlled blood fridge, could provide a key element of the overall solution. a radio frequency identification (rfid) fridge racking system was installed in a standard blood bank fridge and connected to the laboratory information management system (lims) common to both the remote and central blood bank. the central blood bank was enabled to test patient samples from the remote laboratory, identify components located in the remote fridge suitable for the patient and allow correct component issue, even when qualified staff were unavailable in the remote laboratory. testing has concluded that installation of remote fridge management can play a major role in helping to maintain a remote inventory permitting patient compatible components to be issued. by sustaining transfusion services in remote communities we can avoid transportation of patients who require transfusion support to locations miles from home. antibodies to hna- b, fcgriiib and hna- have been reported, too. neonatal alloimmune neutropenia results from maternal antibodies transferred transplacentally to the fetus and is caused by all known hna-antibody specificities, i.e. hna- a, - b, - c, - d, hna- , hna- a, - b, hna- a, - b and hna- a specificity. hna and hla antibodies can induce mild febrile transfusion reactions and trali. since the introduction of the male only plasma strategy, in many countries the trali incidence decreased but it is still one of the most common causes of severe transfusion reactions. especially hna- a antibody containing plasma from female donors is responsible for severe or even fatal reactions. but also hna- a, - b, hna- and hla class i and class ii antibodies were reported. the latter activate monocytes to secrete soluble factors that act on the primed neutrophils in the narrow lung capillaries. laboratory testing: laboratory work-up requires the knowledge of the patient's clinical condition and the methods that are appropriate to detect the relevant antibodies. the classical granulocyte agglutination test (gat) in combination with the granulocyte indirect immunofluorescence test (gift) can detect nearly all relevant antibodies. hna- , - , - , - and hla class i antibodies are clearly detectable in the gift while hna- antibodies strongly agglutinate neutrophils in the gat. the monoclonal antibody-specific immobilization of granulocyte antigens (maiga) test detects all hnaantibodies except for hna- with high glycoprotein specificity and sensitivity but is time consuming and requires highly skilled personnel. for trali diagnostics laboratory testing is completed by methods like the indirect lymphocyte immunofluorescence test (lift) or elisa for hla class i antibodies and hla class ii specific elisas. since several years fluorescent bead based assays (luminex) enable faster and more automated hna antibody detection but to date not all specificities, especially hna- , can be reliably detected so that still the classical gift and gat have to complete the methodological spectrum. serological typing today is mostly reduced to the determination of hna- in the gift because the molecular reason for the hna- -null phenotype is not completely understood. establishing only one pcr-asp reaction for the main cd * a>t polymorphism would comprise the risk to miss other molecular causes. however, for all other hna allelotyping by pcr methods is the first choice. summary/conclusions: granulocyte serology still today is widely based on a variety of manual methods and will be reserved to specialized laboratories as it requires experienced laboratory staff and profound knowledge of granulocyte immunobiology. d- - norwegian national unit of platelet immunology, laboratory medicine, university hospital of north norway, tromso, norway maternal alloantibodies against antigens on human platelets can cause severe thrombocytopenia and bleeding in fetus or newborn, identified as fetal/neonatal alloimmune thrombocytopenia (fnait) . although most cases the thrombocytopenia is selfresolving within the two first weeks of life, some infants present bleeding symptoms and thus require platelet transfusion. a set of laboratory analyses are required to confirm the fnait diagnosis. in addition to guiding compatible platelets to the affected newborn, the correct diagnosis will be valuable to assess the risk of fnait in subsequent pregnancies. in addition, platelet alloantibodies may also complicate platelet transfusions by immune-mediated platelet refractoriness, and require proper identification of the patient's antibody specificities prior to selection of donor platelets. the algorithm for laboratory investigations include both serological and molecular assays, and depend on the objective and timing: whether there is an urgent need for platelet transfusion, follow-up of a pregnancy with known risk, or to do full-scale laboratory testing to confirm diagnosis. molecular genotyping should include all hpa systems relevant for the local population (in caucasians hpa- , - , - , - and - ), preferably with optional extended panels for systems for low frequency populations due to immigration/mobility and for less frequently seen alloantibodies (hpa- , - to - are most commonly included). serological testing of antibody binding to platelets is often initially tested by flow cytometry analysis (direct test and/or cross-match). however, the detection of platelet-specific antibodies is often complicated by the presence of anti-hla class i antibodies and thus require sensitive platelet glycoprotein-specific assays. serological testing for platelet-specific antibodies includes as a minimum panels of antigens on gpiib/iiia, gpib/ix, gpia/iia and cd and preferably additional targets for populations with asian/african origin. several methods are available; i.e. bead-based assays and elisa based methods. however, most reference laboratories perform variants of the monoclonal antibody immobilization of platelet antigens assay (maipa), as reported by the th international platelet immunology workshop of isbt ( ) . the investigations also include measurement of the anti-hpa- a by quantitative maipa if present, as this is reported to potentially predict the severity of fnait. for pregnancies with known risk of fnait, there are methods available to perform non-invasive prenatal typing from maternal plasma. the most feasible and so far appropriate for routine testing is fetal hpa- typing with quantitative pcr or by melting curve analysis. other sophisticated, yet resource-demanding techniques have also recently been reported -importantly also for typing of other hpa-systems. d- - molecular basis of hna- expression justus liebig university, institute for clinical immunology and transfusion medicine, giessen, germany human neutrophil antigen (hna- ) is a neutrophil-specific antigen located on gpi-anchored glycoprotein cd (also known as nb ). hna- is absent on the neutrophil surface of - % of the healthy individuals that divided the population to hna- positive and hna- null individuals. exposure of hna- null individuals to hna- positive neutrophils during pregnancy, after transfusion or transplantation, induces immunization against hna- and consequently the production of iso-antibodies. the hna- iso-antibodies are involved in the mechanism of neonatal alloimmune neutropenia (nain), transfusion-related acute lung injury (trali) and graft failure following bone marrow transplantation. presence of cd on a neutrophil surface of hna- positive individuals follows a bimodal expression that categorizes the circulating neutrophils to hna- positive and negative subsets. the cd gene contains exons encoding a protein of amino acids. the lack of hna- (in hna- null individuals) is associated with the presence of a missense mutation, cd *c. a>t in exon of cd gene inducing a premature stop codon in codon . this mutation alone or in combination with cd *c. delg has been introduced as the main reason for the absence of cd in hna- null individuals. a pseudogene (cd p ) highly homologous to exons - of cd gene is located downstream of the cd gene. conversion of exon of cd p into cd gene is responsible for the generation of cd *c. a>t missense mutation. in addition, the heterozygosity or homozygosity of cd *c. a>t is accounted for regulation of hna- negative and positive neutrophils subpopulations. genotyping has revealed the hna- null individuals, heterozygous for cd *c. a>t mutation without cd *c. delg, indicating the presence of a complementary mechanism regulating cd expression. newly in hna- null individuals and individuals with atypical cd expression a cd * g>a polymorphism in combination with cd * a>t is described. altogether these data indicate a complex compound mechanism(s) for regulation of cd expression on the neutrophil surface. this presentation will summarize recent findings on cd expression and highlights the potential genotyping methods for genetic assessment cd expression of donors and patients. blood products ordered, transfusion start and end times, whether patients experienced a reaction to the transfusion as well as vitals measurements taken before and during the transfusion, including temperature, oxygen level, blood pressure and heart rate. for the validation process, transfusion nursing notes were sampled and reviewers assessed the accuracy of the information regarding ) blood product ordered, ) whether the patient experienced a reaction, and ) the start and end times of the transfusion. for each of these fields across all sampled notes, the claritynlp tool reproduced these data points with percent accuracy. in addition, the tool supplied transfusion end times for numerous structured records that were missing this key data point. summary/conclusions: claritynlp can very efficiently digest a large number of transfusion nursing notes simultaneously and also does an excellent job of extracting the main characteristics of a transfusion, which can be used in partnership with structured data to produce a more accurate and more complete picture of patient transfusions. immunohematology and genomics, new york blood center, new york, united states antibody-based typing, with a positive result reflected in agglutination of the red cells (rbcs), has served the profession for nearly a century enabling safe and effective transfusion therapy. the power of rbc typing by serologic methods lies in the availability of standardized antibody reagents which target many of the specificities of significance for transfusion, and the ability to directly detect antigen expression on the rbcs. hemagglutination has historically been relatively inexpensive, particularly for abo and rhd as the most important blood groups in most populations. serologic rbc typing is reliable, requires no sophisticated equipment, is generally straightforward to perform, and is fast requiring less than h to results. hence, antibody-based testing has been considered the "gold standard" for blood group typing. with the age of genomics, dna-based genotyping is increasingly being used as an alternative to antibody-based methods. most antigens are associated with single nucleotide changes (snps) in the respective genes. genotyping has been validated by comparison with antibody-based typing and has been shown to be highly correlated. the power of genotyping of rbcs lies in the ability to test for antigens for which there are no serologic reagents, and to type numerous antigens in a single assay using automated dna-arrays. this increases accuracy and weak antigen expression can be revealed. fresh rbc samples are not required for dna extraction, and there is no interference from transfused rbcs or igg bound to the patient's rbcs. dnabased typing is economical in that it provides much more information, but testing requires special equipment, training, and -h turn around. what then is the best approach to use? will serologic typing be replaced by dnabased typing? indeed, genotyping will increasingly be used in the practice of transfusion medicine, especially with the growth of whole genome sequencing (wgs). however, because serologic typing for abo and rhd is fast and accurate and often relied on for sample identification, genotyping will not be the sole means for routine typing. genomic sequencing approaches will certainly reveal unrecognized changes and genetic variability in rbc membrane proteins, but not all variation will be immunogenic. a genetic polymorphism must be associated with antibody production to be considered a blood group antigen. the importance of an antibody, and antibody reactivity, then will continue to be the central defining principal in transfusion. as two sides of a coin, both are key to safe and effective transfusion therapy. since the mid- s, research in the molecular basis of structural and functional aspects of proteins carrying and producing the antigens has led to an upgraded and modern understanding of blood group variation. most commonly, single nucleotide polymorphism (snp) based basic molecular typing techniques were utilized to test new findings on a smaller subset of samples, and resulted in concordant sero-and genotyping results in general. however, quite commonly a small number of all samples delivered discrepant results, triggering consecutive rounds of analysis and resolution, finally resulting in a better knowledge with respect to the underlying blood group variation. such rounds of repetitions represented the synergistic incremental process of learning, learning for serologists and molecular biologists. inheritance of public, presence of high frequency, or low frequency, or partial antigens and notice of weakly expressed, or almost undetectable antigens marked the path of incremental learning and may best be exemplified by discoveries within the blood group systems abo, rhd and kell. naming for pheno-and genotypes coevolved alongside the permanent discovery of new antigens. at present, antigens and their antithetic counterparts (if tested and if existent), are more commonly reported independently, as exemplarily shown for the following kell phenotype consisting of three antithetic antigen-couples: kk, kp (a+b+), js(a+b+). alternatively, the same phenotype could be stated as: kel:- , , , , ( ), , . genotypes, on the other hand, rather mirror the actual biological background, e.g. display the two parental alleles (or "haplotypes") present in an individuals' sample. genotype of the above mentioned example would read: kel* . / . (italicized). in an idealized diagnostic environment and for most blood group systems encoded by proteins, every single blood group allele would be defined by its full genomic sequence, derived from one parental chromosome (including "some" 'and '-untranslated regions). thereby, every such "ideal allele" would fully declare presence or absence of all its public, low-and high-frequency antigens and possess its "ideal name". by trend, biallelic snps and their immediate relation to antithetic antigen couples might have distracted from the originally intended meaning of "blood group alleles", more recently. finally, genotypes only dependent on (ideal) allele names, and considering mendelian inheritance patterns (dominant, recessive), would allow for fully comprehensive phenotype predictions. more recently, blood group serology, e.g. the "second side of the coin", seems to gain momentum. since the advent of whole genome sequencing and access to many more than human genomes, it seems that dozens of new blood group alleles are discovered, almost on a daily basis. beside the challenge of naming this multitude of alleles, respective discoveries are frequently made in samples lacking any phenotypic blood group pre-values. clear procedures will be needed to address naming and analyzing the phenotypes resulting from previously unknown alleles. as a consequence, questions asked years ago have changed: today, molecular biologists looking at hundreds of newly discovered blood group alleles find themselves not being asked by serologists any more: "can you confirm my serology?", but instead, pose their question to the experts for the blood group phenotype: "can you confirm my genotype?" a-s - background: the screening of blood donors and returning travelers from active transmission areas have highlighted the importance of diagnosis of acute arboviral infections. in the context of co-infections and similar clinical signs in endemic zones, the differential diagnosis of arboviruses is essential to discriminate the causative agent. the detection of viral nucleic acids in serum or plasma provides a definitive diagnosis, however, in most instances, viremia is transient within less than two weeks after the onset of clinical illness. in addition, the cross reactivity due to the high degree of structural and sequence homology between zikv and other flaviviruses is a significant concern. the combination of molecular (identification of viral genomes) and immunological assays (detection of the immune response) is a key challenge to follow the natural history of these infections and to improve the patient management and the epidemiological surveillance. aims: in this context, we have developed an innovative platform based on agglutination of superparamagnetic nanoparticles (npmag) covalently grafted either with nucleic or proteic probes to face the continuing emergence of arboviruses. methods: dengue (denv) and zika (zikv) viruses are selected as models in this study. a pan-flavivirus rt-pcr is used for the molecular assay to amplify the viral genomes. then, biotinylated viral amplicons are captured specifically on complementary original polythiolated probes coated on npmag. for the immunological assay, npmag are grafted with viral ns proteins to capture anti-denv or anti-zikv antibodies potentially present in the plasma samples. both tests are performed in disposable cuvettes in a homogeneous format. a magnetic field generated by an electromagnet is applied to the reaction medium to align the npmag into chains to enhance the capture of the targets between two npmag. aggregates formed are detected when the field is turned off. the optical density is measured in real-time at nm during several cycles of magnetization / relaxation. results: in this study, molecular analytical performances were evaluated on human samples from blood donors with no history of infections as negative controls, on viral standards and on clinical samples. using viral references standards, we have observed sensitivities of - tcid /ml for zikv and denv (serotypes / / / ) after a detection phase of around min. the first results obtained on zikv (+) clinical samples previously tested by commercial real-time pcr (ct < , altona) showed an % correlation between the two detection methods. no false positive results or cross reactions were observed. concerning immunological assays, commercial human plasma from donors tested positive for denv or zikv antibodies were detected positive with our innovative approach in less than min (sampling + detection) instead of h with classical elisas. further assays on clinical samples are planned to confirm these preliminary results. summary/conclusions: this innovative strategy combining molecular and immunoassays on the same analytical platform offers new opportunities for rapid blood testing to improve the surveillance and the prevention of arboviral infections. background: zika virus (zikv) caused a dramatic epidemic in puerto rico (pr) during , with up to~ % of blood donors reactive for zikv rna in id-nat testing at the peak in june . aims: perform a serosurvey for anti-zikv igg using six panels of donor specimens each collected in march , at the beginning, peak and end of the epidemic, and from march and april . methods: we employed a commercially available zikv igg elisa antibody (ab) assay based on the zikv ns antigen from bio-techne to characterize zikv seroprevalence in the cross-sectional sample sets (anonymized with selected demographic information). results: pr donor samples collected in april were initially evaluated using the manufacturer supplied cut-off to confirm that the zikv ab results were largely negative ( positive, equivocal) despite the high dengue virus seroprevalence (> %) in pr that could potentially lead to false positive zikv ab results. we then used this dataset, together with known positives collected - months postdetection from zikv nat yield donors, to set a population-specific cut-off based on receiver operating characteristic (roc) curve analysis. this cut-off yielded sensitivity and specificity values of > %, and an area under the curve (auc) of . , demonstrating a highly accurate assay. we used this new cut-off to calculate final rates of seroreactivity in the additional sample sets ( samples) and estimate seasonal incidence. rates of reactivity, together with mean net od for only the reactives (shown in parentheses), were calculated for each sample set: background: sex hormone intake in blood donors occurs in three demographic groups: premenopausal women who take contraceptive drugs (progestins with or without estrogens), postmenopausal women who receive estrogen replacement therapies that may be combined with progestins, and testosterone therapies in men. we hypothesized that sex hormone therapies may modulate the quality of red blood cell (rbc) products via alterations of rbc function and predisposition to hemolysis during cold storage. aims: the objectives of this study were to evaluate the association between sex hormone intake and rbc measurements of hemolysis, and to examine possible mechanisms by which sex hormones interact with rbcs. methods: self-reported sex hormone intake and menstrual status were evaluated in , female blood donors from the national heart, lung and blood institute's rbc-omics study. the associations between hormone intake and donor scores of spontaneous storage, osmotic, or oxidative hemolysis were determined in all women and by menstrual state. the interactions between sex hormones and rbcs were determined by sex hormone (progesterone, b-estradiol, or testosterone) potency to inhibit calcium influx or hemolysis during incubations or cold storage. the calcium fluorophore, fluo- am, was used to define rbc calcium influx in response to treatments with sex hormones or drugs that modulate transient receptor potential cation (trpc) channel activity including hyp (a selective trpc activator). results: sex hormone intake by menstrual status was higher in premenopausal women ( . %) than in postmenopausal women ( . %). female hormone intake was significantly (all p < . ) associated with reduced storage hemolysis in all females ( . ae . % versus . ae . % in controls), enhanced susceptibility to oxidative hemolysis ( . ae . % versus . ae . % in controls), and reduced osmotic hemolysis in postmenopausal women ( . ae . % versus . ae . % in controls). in vitro, supraphysiological levels of progesterone ( or lmol/l), but not b-estradiol or testosterone, inhibited spontaneous or hyp -induced calcium influx into rbcs, and were associated with lower spontaneous hemolysis after day cold storage ( . ae . % versus . ae . %, progesterone lmol/l versus solvent control (dimethyl sulfoxide, . %), p < . ). co-incubations ( . h, °c) of rbcs in the presence of progesterone and a trpc activator (hyp , lmol/l) suggested that progesterone protected against hyp -induced hemolysis ( . ae . % and . ae . % versus . ae . %; hyp + progesterone at or lmol/l versus hyp alone, p < . by one-way anova). summary/conclusions: this study revealed that sex hormone intake in blood donors is capable of modulating rbc predisposition to hemolysis and led us to propose new mechanistic pathways by which progesterone regulates calcium influx and hemolysis in human rbcs. pre-and postmenopausal women respond differently to hormone intake and its effects on rbc responses to osmotic or oxidative stress. progesterone modulates calcium influx into rbcs via a mechanism that may involve interactions with membrane trpc channels, activation of which is associated with pre-hemolytic events such as senescence and eryptosis. a-s - international cooperation, swiss red cross, wabern, switzerland background: red cross and red crescent societies were playing an important role in setting up blood transfusion establishments in many low resource countries. by the mid- s, the red cross was active in the national blood programs in approximately % of countriesmostly in blood donor recruitment and education. today, major organizational developments in blood transfusion services were made in high income settings, where nearly % of all worldwide donations take place (home to only % of the population). who data shows that the median annual blood donation rate in high-income countries is . % of the population compared to . % in low-income countries. the factors for this low turnout are multilayered, but it is well-known that most resource poor settings suffer from a low rate of regular donors and challenges to set-up and financially sustain a national blood donor program. the red cross and red crescent (rc) societies assume a key role by reaching and retaining donors from the communities and contribute significantly to better safety and availability of blood. partnerships and international collaboration, such as the swiss red cross (src) program, are aiming to strengthen national structures to improve blood safety and to face today's epidemiological, demographical, and technological challenges. aims: the present work aims to review the role, the mandate and the impact of rc societies in improving blood safety through systematic "voluntary non-remunerated regular blood donor" (vnrbd) programming and international partnerships. methods: data and evidence is drawn from the src international cooperation projects over the last years, more specifically partnering with three rc societies, and the data from the global advisory panel (gap) of the ifrc including their global mapping. results: the promotion of vnrbd has been a specific objective in all src supported programs. through the engagement of the rc society, the training of volunteers and partnering with the health authorities, the projects significantly increased the blood donor rate by recruiting and retaining donors from the communities. for example, the rc societies increased total donations by % in lebanon; vnrbds by % annually in kirgizstan, and from practically zero to ' in south sudan. the importance of rc societies was also underlined in the published global mapping of gap, which showed that ( %) of them provide level a (full blood service), ( %) are level b (systematic blood donor recruitment) and ( %) are level c (vnrbd blood promotion) blood services. gap has also commenced a new three year vnrbd support program aimed at establishing tools and materials for national societies. summary/conclusions: the red cross / red crescent movement has a unique mandate and position in improving global blood safety at all levels; with its huge network of volunteers, even blood donors in remote communities can be reached and retained. rc societies in low resource settings with a level b or level c role should further capitalize on partnerships with local and international actors to leverage technical assistance and funding for their activities. background: it is essential to motivate and encourage the public to donate blood and be eager to help saving lives, in order to maintain safe and adequate national blood supply. aims: "technical assistance for recruitment of future blood donors (europeaid/ /d/ser/tr)" project aimed to avoid problems in supplying the safest blood to contribute to the improvement of public health by (i) increasing the knowledge of primary and secondary school students regarding blood donation, (ii) creating sensitivity in school principals and teachers regarding voluntary non-remunerated blood donation (vnrd), (iii) motivating family members of the students for blood donation and (iv) creating public awareness through media. methods: an effective coordination is established between ministry of health (moh), ministry of national education (mone) and turkish red crescent (trc). the existing curricula and textbooks of primary and secondary schools were reviewed and revised, and corresponding materials on the importance of blood donation were created. the human resources capacity of moh, mone and trc to support raising awareness on blood donation were developed. to raise public awareness on blood donation nationwide, education and recruitment campaigns on were organized in pilot schools. additionally, media and public relation campaigns on blood donation were organized throughout the country. results: ( ) existing curricula and textbooks relevant to promoting blood donation were reviewed, revised and reported to the board of education of mone. ( ) corresponding educational materials for students and teachers were developed and distributed. ( ) blood donation clubs were established in pilot schools. ( ) trainings were conducted for personnel of moh and trc on blood donation regarding their responsibilities. ( ) cascade trainings were conducted for personnel of transfusion centers and school principals in provinces. ( ) information seminars were delivered to . students and . teachers and family members of students during school campaigns. ( ) four animation films on blood donation were produced and broadcasted on the national tv channel (trt). ( ) three different computer games targeting different age groups were developed and uploaded to the web portal of the project and distributed to the pilot schools. ( ) media spots were produced and broadcasted . times in different tv and radio channels. ( ) billboard posters and brochures were prepared and distributed to provinces for raising public awareness. ( ) advertisements about the project and the importance of vnrd were displayed times on national and local newspapers, . times on online news, and broadcasted on national tv channels. ( ) during the campaigns, . units of whole blood were collected in pilot schools. ( ) visibility kits to recruit future blood donors are prepared and distributed throughout the project activities. ( ) awareness and knowledge level of students and their teachers/parents on the importance of blood donation are increased to . % and . % respectively, assessed through pretest and posttest. voluntary non-remunerated donation rate of national demand increased from . % to . in two years. summary/conclusions: training and campaign programmes successfully increased the knowledge on blood donation. to achieve national self-sufficient safe blood supply, efforts for recruitment should be continued. background: despite % of pakistan's population being under years, only % of blood supplies come from voluntary donors while remaining blood is collected from 'family replacement donors'. in pakistan the system has outsourced the mobilization of blood donors to the patient families. as a result many people reach out to their networks including on facebook to locate blood donors. there are thousands of posts each month in pakistan seeking blood donors on facebook. to facilitate needy families, the global social media giant facebook launched a special blood donation feature for pakistan in collaboration with sbtp, pakistan. the feature makes it easier for people to sign up to become blood donors and helps connect these voluntary donors with people and organizations in need of blood. similar features have been launched by facebook in india, bangladesh and brazil to address the problem of blood shortages in those countries. however, among these four countries pakistan has unique position because of the existence of a national counterpart, sbtp which can facilitate facebook in promoting its feature and provide the feedback on the impact of this innovative effort for continuous improvement of the feature. aims: to promote voluntary blood donations and blood safety in pakistan through facebook. methods: the facebook and sbtp teams launched a pilot to study the impact and effectiveness of the facebook blood donation feature as a tool of community engagement. a six months plan has been chalked out to measure the impact of this tool in five selected blood centres. a checklist called "p checklist" was shared with these blood centres to fulfill some basic requirements for an official blood bank page including a display picture, cover photo, contact information, directions, etc. regular skype meetings are held between the teams of sbtp, facebook (san francisco and singapore) and the blood centres to monitor the progress of the pilot and generate feedback. results: the facebook blood donation feature has recorded remarkable success with over one million signups within few months in pakistan. the blood centres participating in the pakistan study have experienced enhancement in the voluntary blood donations trend with - walk-in donors and an average of more than telephonic queries regarding voluntary blood donation per month in each center. the trend is gradually surging as the feature is being refined on the basis of feedback received. the pilot will end in june . the statistics generated since january are very encouraging and underscore the importance of social media in reaching out to the untapped potential blood donors. the study will be used to plan an effective nationwide strategy to increase donor mobilization, recruitment and retention. background: in our region, an increasing number of patients of african or asian origin with sickle cell disease (scd) or transfusion dependent thalassemia (tdt) require red blood cell (rbc) transfusions, and many have rbc alloantibodies. selecting optimally matched rbc units for these patients is essential for preventing not only acute hemolysis but also further alloimmunisation. beside antigen-matching for abo, rh d, c, c, e, e and k, patients with scd and tdt should ideally receive rbc units matched also for m, s, s, fya, fyb, jka and jkb (extended phenotype). this is the policy at our center, which currently provides rbc products to patients with hemoglobinopathies. because the vast majority of our blood donors are caucasians, the selection of matched rbc units for patients of different ethnic origin can be difficult. therefore, expanding the number of available african and asian blood donors is becoming increasingly necessary. aims: hereby the recruitment strategy of non-caucasian blood donors introduced at our center is described and the results obtained during six years are reported. methods: since . . , whenever a first-time blood donor of non-caucasian origin is registered, an alert is entered in the donor file to trigger the determination of the extended rbc phenotype along with routine testing. rbc antigen determination is performed in our laboratory with serologic methods. in selected cases (i.e. suspected rhd or rhce variant), samples are sent for molecular analysis (ssp pcr). rare rbc phenotypes relative to ethnicity are, among others, fy(a-b-), s-s-, lu(b-) and those with uncommon rh phenotypes. if a rare rbc phenotype is detected, a coded comment is entered in the donor data and the donor is listed in the national rare donor file. results: from . . until . . , an extended determination of rbc antigens was performed in subjects presenting for blood donation. twenty-nine rare donors ( %) were identified and included in the rare donor file: fy(a-b-), lu (a-b-), lu(b-), fy(a-b-) and s-, ccddee (r'r'). overall, these donors provided rbc units (range . to date, all donors are still active and are reserved for dedicated donations. the internal price of rbc antigen testing per donor is approximately . -chf, resulting in a total financial effort of around , .-chf in the time since the project was started. summary/conclusions: in our experience, a "passive" recruitment of non-caucasian blood donors based on ethnicity has an overall low efficiency from a logistic and financial point of view. moreover, african and asian blood donors may require investigations for hemoglobin variants and serology for malaria in addition to routine testing. nevertheless, a targeted determination of extended rbc antigen phenotype does allow the identification of persons with rare phenotypes. currently, measures for the active recruitment of potentially rare blood donors are being implemented at our center. after a pilot phase, a project for a nationwide recruitment strategy will be elaborated. a further goal is to build a national registry of patients with hemoglobinopathies requiring transfusions. blood transfusion is an essential treatment. transfusion safety consists of several components. although all are important, ion richer countries the order of priority is typically: .) avoidance of transfusion transmittable infections; .) quality of the blood product with a strong focus on component therapy; .) prevention of severe transfusion reactions; .) avoidance of clerical errors; .) sufficient availability of blood. the keynote of this lecture will be that the order of priorities on transfusion safety should probably be different in resource limited environments. .) sufficient availability of blood and proper utilisation; .) avoidance of transfusion transmittable infections; .) avoidance of clerical errors; .) prevention of severe transfusion reactions; .) quality of the blood product. most important, in regions with limited resources patients suffer from under-transfusion because not enough blood is available. all efforts should be made to reduce wastage of the available blood either by inappropriate storage, handling, or nonindicated transfusions. in addition, prevalence and number of pathogens transmittable by transfusion is much higher than in the richer parts of the world. this is aggravated by the fact that rejection of blood donors based on their history is problematic when the blood bank is empty. the aim to develop centralized national blood services with few sites manufacturing cost effective (low personnel costs) high-quality blood products, which are distributed to regional hospitals is not matching the reality of infrastructure, governmental support, and functionality. in healthcare systems with limited resources usually available personnel (hands) is not a problem, while reagents, equipment and even electricity are precious resources. the lecture will propose to focus on staff training and education, establishing local hospital-based transfusion services, which provide the blood products for the region, based on donor recruitment campaigns adjusted to the available technology, local culture, including replacement donor programs, with retention of safe donors as highest priority. fractionation of blood into components had been standard in transfusion medicine, but recently whole blood has experienced revival for patients with acute blood loss. given main transfusion indications such as postpartum hemorrhage, or severe trauma, in regions with limited infrastructure, whole blood might be the more appropriate product. most patients requiring transfusion in these regions are younger and volume overload by whole blood is not a major issue. in addition, frequent electricity failures do not allow prolonged storage of plasma at - °c (this is therefore mostly wasted), although this issue can be overcome by solar powered freezers. ideally whole blood should be pathogen inactivated for which two methods are currently available. to reduce frequencies of acute hemolytic transfusion reactions again education and training to minimize clerical errors in the transfusion process are most important. extended testing for other rhesus antigens and k beside abo and rh-d in transfusion dependent hemoglobinopathy patients may help to reduce delayed hemolytic transfusion reactions. currently a leukodepleted pathogen-inactivated whole blood product might mostly serve the needs for blood transfusion in regions with limited infrastructure . the developed world should invest research efforts to develop such a product available at affordable costs. background: in modern transfusion medicine, serological investigations for blood cell antigens are complemented by genotyping arrays and pcr assays. whilst these platforms are informative in the majority of reference investigations, they are limited in their ability to define nucleotide variants associated with rare antigens and unable to detect novel variants potentially affecting antigenicity. next-generation sequencing is increasingly being employed in reference settings, providing information that cannot be obtained through these methods. whole genome and whole exome sequencing have been successfully employed in many investigations of novel and rare antigens, however concerns remain regarding the collection of genomic data unrelated to reference investigations, and reporting clinically significant incidental findings. these concerns can be addressed through the use of targeted sequencing panels. we report on the design, testing and efficacy of a panel providing a comprehensive genotyping profile for red cell, platelet and neutrophil antigens in a single test. aims: design a customised targeted exome sequencing panel for red cell, platelet and neutrophil antigen genes, and benchmark the efficacy against a commercial medical sequencing panel (illumina trusight one -tso). -test the panel and in-house genotype prediction script on sequence outputs from samples with known red cell, platelet and neutrophil genotypes and phenotypes and determine whether predictions are concordant. methods: the panel was designed with probes covering exons of genes associated with red cell, platelet and neutrophil antigens. using illumina nextera rapid capture technology, samples were tested over five sequencing runs, on standard and micro chemistries, to determine optimal sample plexity per standard run, and the efficacy of smaller flow cells for lower throughput applications. an in-house python script was used to predict star-allele genotypes based on variants listed in isbt and embl databases. these predictions were compared to results from serology, snp array and previous tso data. results: coverage consistently averaged > , with % of target at a quality of q . optimal sample plexity for a standard run was determined to be samples, allowing for sufficient coverage of all clinically significant variants. for red cell samples with previous typing data (excluding rh structural variants), the script correctly predicted . % of snp based red cell genotypes. script predictions were % concordant for platelet genotypes, and four of five neutrophil antigen genotypes. hna genotypes defined by cd could not be reliably determined. the increased target coverage of the panel allowed for detection of a clinically significant heterozygous variant in scianna system, previously undetected by the tso panel due to extremely low coverage. additionally, a variant defining a potentially novel null allele was detected in the p pk system. summary/conclusions: the panel demonstrates considerably higher coverage, quality and throughput compared to the tso and allows for detection of variants previously overlooked due to low sequencing coverage. up to samples can be reliably sequenced in a single run. our script correctly predicts over % of snp based alleles; however, rh structural variants require further manual analysis. background: to ensure the safety of a transfusion it is critical to identify the blood type of both donor and recipient. serological methods for typing abo, rh and kel use monoclonal antibodies, however, typing reagents for rare blood groups are expensive, unavailable or unreliable. dna-based identification of human blood groups has been used to overcome these limitations and its application has reduced rates of alloimmunisation in chronically transfused patients. however, to date, the cost per sample has prevented the universal application of dna-based donor typing aims: to achieve universal adoption of dna based donor typing, the blood transfusion genomics consortium (bgc) set out to develop an affordable dna based platform, capable of typing all red cell antigens, hla class i and ii and human platelet antigens. methods: the uk biobank axiom array, previously used to type , uk citizens, was redesigned for donor typing using three approaches: i) mining transfusion medicine knowledge, e.g. isbt allele tables; ii) inclusion of loci associated with donor health; iii) extraction of all coding variants in relevant genes with a frequency > : , identified in large-scale sequencing data. samples from nhsbt and sanquin blood donors (n = , ) were used for performance assessment. red cell and platelet antigens for each donor were inferred from genotypes using the bloodtyper algorithm and concordance with clinical serological typing results assessed. results: concordance between genotypic and serological typing results was . % for , comparisons; of the discrepancies were serologically negative and genotypically positive for a given antigen (k/k, fy[a/b], lu[a/b]). in all cases dna variants known to modify or weaken antigen expression were detected, displaying the power of genotyping to detect variant 'weak-antigen' expression. across antigens for which serology was available, genotyping provided a . -fold increase in the number of typing results available per donor ( . vs . ). furthermore, genotyping provided data on an additional clinically relevant antigens, allowing identification of antigen-negative donors and blood group identification for which antibodies are not commercially available. the power of a genotyped panel of donors to support patient management was demonstrated by a retrospective analysis of clinical cases referred to nhsbt. from , patient referrals with > alloantibodies between and , unique alloantibody profiles were identified. we found that there was a . -fold greater likelihood of finding o negative compatible donors for these patients when using genotyping data from the , nhsbt donors. importantly, the number of alloantibody combinations for which no compatible antigen-negative donor could be identified fell from to , representing an additional patients that could be provided with directly compatible blood using the same donors. summary/conclusions: through the bgc efforts an affordable fully automated genotyping platform, including the processes for quality assurance and data analysis, has been developed. furthermore, we have demonstrated the real-world benefits more extensive donor characterisation can provide when selecting blood for patients with multiple antibodies. the results of this international collaboration provide opportunities to introduce fully-automated genotype-based donor typing in a safe and cost-efficient manner in blood supply organisations. c-s - biobank performs whole-genome sequencing (wgs) from individuals nation-wide. these data are suitable for allele frequency analysis to demonstrate gene expression and genetic profile in our population, also to estimate the significance of each antigen in transfusion practice. aims: we aim to provide and verify population-based blood group antigen profile using wgs and dna samples from taiwan biobank. methods: a near wgs and demographic data were analyzed. annotations of blood group antigen were performed according to variants from isbt allele tables, including transcription factors; variants for the lewis system were obtained from previous studies. annotations of blood group variants were verified by dna samples with targeted sequencing on illumina miseq, and specific variants were verified by dna samples with the commercial genotyping kit or sanger sequencing. allele frequencies from wgs analysis were compared with population serology data using two-proportion z test. results: population-wide blood group antigens were analyzed, revealed in-depth antigen expression profiles in all systems (except ch/rg). the antigen frequencies from wgs were similar compared with published serology data, except for the antigens and possible explanations listed as follow, ) m, n: insufficient sequencing reads, ) c, c: identical rhce exon with rhd exon for c allele, ) mur: insufficient read length/depth for gypa/gypb hybridization calling and individuals from high prevalence of mur antigen in aboriginal tribes were not enrolled. blood group antigen predictions and variants from wgs were accord to dna verification. furthermore, systems shown no genetic variations, predicting uniform antigen expression in our population, and we can manage transfusion with minimum concerns for antigen mismatch in these systems. moreover, we found weak and null alleles in our population for blood group systems that we had previously no knowledge of, such as lan, jr, and vel. these variants were helped to identify a patient with anti-jr a carrying homozygous jr a null alleles. summary/conclusions: taiwan biobank wgs is suitable for full blood group antigen profile determination with few adjustments required for specific antigens. the population antigen allele frequency provides valuable insight to antigen significance in transfusion practice, matching strategy for our patients, and estimation of the likelihood to obtain for specific antigen negative blood from mass population. also, the genetic variants revealed in this study can help us to locate rare donors, and to integrate variations into routine donor blood group screening to provide suitable blood at a low cost efficiently. background: providing adequate amounts of safe, appropriately matched blood to meet the demands of an expanding and aging patient population presents a challenging global problem. for these reasons, sustainable in vitro sources of red cells may offer a desirable alternative to reliance on donor blood. the first stable immortalized early adult erythroblast cell line, bel-a , has been shown to differentiate efficiently into mature, functional reticulocytes (trakarnsanga et al., nat commun. : , ) and consequently could provide a readily available tool for diagnostic use and proof of principle for future therapeutic use. aims: at ibgrl, next generation whole exome sequencing (wes) has been used previously to accurately predict blood group phenotype in a number of blood group systems, including abo, rh and mns (tilley & thornton, transfusion medicine (suppl. ) : , ). here we have used it to analyse and document bel-a blood group-related genotypes and predict blood group phenotypes. additional genes involved in cell-growth and enucleation were also analysed in order to further elucidate the characteristics of the bel-a cell-line. methods: bel-a cells (day ) were cultured in expansion medium and genomic dna (gdna) was isolated from cells on day . for wes, gdna libraries were prepared using nextera â rapid capture exome enrichment and sequenced on illumina â miseq. sequence alignments for genes encoding all known blood group systems and further genes encoding transcription factors and cell enucleation-associated proteins were visualised using integrative genomics viewer, whilst illumina â variant studio was used to identify observed mutations. mutations in coding regions were used to determine bel-a genotype and predicted phenotype. results: good coverage of most of the selected genes was achieved. alignment of homologous blood group genes including rhd/rhce, gypa/gypb and c a/c b was problematic and additional analysis of coverage of these genes was required for accurate interpretation. despite a number of polymorphisms observed across the tested genes, bel-a did not express any novel or rare blood group antigens. genotyping results predicted a common antigenic profile, in agreement with previous serological and genotyping results where available. although a number of missense single nucleotide variations were detected in analysed genes, including cr , cdan and tmx , these were common polymorphic variants and unlikely to be of any functional significance. summary/conclusions: wes was used to determine bel-a genotype in relation to blood group genes and selected genes encoding transcription factors and proteins associated with cell enucleation. wes allowed accurate prediction of blood group phenotypes, showing full concordance with available serological data (trakarnsanga et al, ) . a small number of mutations were identified which are of unknown significance and require further work to determine any potential phenotypic effects. this complete record of the bel-a blood group-related exome will enable reliable gene editing strategies for future diagnostic and therapeutic purposes. additionally, knowledge of the full cell line exome will allow analysis of any emerging genes of interest and provide better insight into the mechanisms of erythroid differentiation and enucleation. background: emerging evidence, especially in neonates, has shown potential harm associated with liberal platelet transfusion strategies. very little evidence exists regarding optimal platelet transfusion thresholds in critically ill children. randomized controlled trials may be difficult due to lack of equipoise from providers. if regional variation in practice exists, comparative effectiveness studies may be an alternative approach. aims: to describe regional variation in platelet transfusion practices in critically ill children. methods: secondary analysis of a prospective, observational study. subjects were grouped according to region (north america, europe, middle east, asia and oceania) and nation. transfusions were analyzed as prophylactic (given to prevent bleeding) or therapeutic (given to treat bleeding). the primary outcome was the total platelet count (tpc) prior to transfusion. sub-groups analyses were performed in children with an underlying oncologic diagnosis and those supported by extracorporeal life support (ecls). the dosing and processing of the platelet transfusions were analyzed as secondary outcomes. results: five hundred and forty-nine children from countries were enrolled ( % in north america, % in europe, % in oceania, % in asia, and % in the middle east). overall, the median (iqr) tpc prior to prophylactic transfusions (n = ) differed significantly on a regional basis (p = . ) and ranged from ( - ) x cells/l in the middle east to ( - ) x cells/l in asia. the median tpc prior to prophylactic transfusions did not significantly differ between countries (p = . ), nor did the tpc prior to therapeutic transfusions (n = ) differ on either a regional (p = . ) or national (p = . ) basis. for children supported by ecls (n = ), there were no regional (p = . ) or national (p = . ) differences for prophylactic transfusions. however, significant differences in the tpc prior to therapeutic transfusions were observed on both a regional (p = . ) and national ( . ) basis with the middle east, in particular israel, transfusing at the lowest median (iqr) tpc [ ( - ) x cells/l]. for children with an underlying oncologic diagnosis (n = ), no differences were seen in the tpc for prophylactic transfusions (n = ) on a regional (p = . ) or national (p = . ) basis. nor were differences seen in the tpc prior to therapeutic transfusions on a regional ( . ) or national (p = . ) basis. there was significant variability in the dosing of platelet transfusions on both a regional (p < . ) and national basis (p < . ). the median (iqr) dose based on volume ranged from . ( . - . ) ml/kg in north america to . ( . - . ) ml/kg in europe. the vast majority of transfusions were leukoreduced and irradiated but significant variation exists in storage duration on both a regional (p < . ) and national (p < . ) basis. summary/conclusions: regional and national variation exists in platelet transfusion practices among critically ill children, especially in those given therapeutic transfusions while supported by ecls. considering this variation, comparative effectiveness studies may be an appropriate approach to gain evidence to optimize platelet transfusion thresholds. background: the optimal threshold for prophylactic platelet (plts) transfusion in pediatric patients with cancer is still controversial and current clinical practice comes from studies on adults and on inpatient setting. the international guidelines (icmtg, ) recommend, for all age patients, a prophylactic platelet transfusion when plts count is ≤ /l and a platelet dose of . per square meter (sm) of body-surface area (bsa) in inpatient and . /sm in outpatient setting. aims: in january we started in our children's hospital a prospective protocol in order to evaluate the impact on bleeding risk of current clinical practice of prophylactic platelet transfusion in inpatients and outpatients onco-haematological patients. methods: bsa was calculated from age-standardized weight. inpatients received a dose per transfusion of . /sm and outpatients a dose per transfusion of . /sm. platelets were transfused when the count was ≤ /l or in presence of bleeding signs; pediatric aliquots were obtained from buffy coat derived pooled platelet concentrates or apheresis platelet concentrates, according disponibility. results: from january to december a total of platelet pediatric aliquots were transfused: ( . %) were obtained from apheresis platelet concentrates and ( . %) from buffy-coat-derived pooled platelet concentrates. the majority of platelets pediatric aliquots ( - . %) were transfused to onco-hematological patients undergoing hematopoietic stem cells transplant (hsct) or conventional chemotherapy. among them, aliquots were transfused in inpatient setting: ( %) in the hematology unit, ( . %) in the oncology unit and ( . %) in hsct unit. a total of ( . %) aliquots were transfused in outpatient setting: ( . %) to patients affected by hematological malignancies and ( %) to patients with solid tumors. five major bleeding events (who grade ≥ ) were observed during the study period and all of them occurred in hospitalized patients. two patients with solid neoplasm developed a who grade bleeding event. two patients with hematologic malignancies and a patient with neuroblastoma (n = , . %) developed intracranial bleeding (who grade ). the platelet count at the time of the event was /l, /l and /l, respectively. summary/conclusions: our results showed the efficacy, in onco-hematological pediatric patients, of a prophylactic platelet transfusion protocol based on international guidelines: a very low incidence of who grade bleeding has been observed in inpatients setting only ( . % vs % of plado trial, sj slichter, nejm, ) , while in outpatients setting the double platelet dose prevents the major bleeding event (who grade ≥ ) occurrence. background: the problem of blood-borne infections remains relevant in transfusion medicine. pathogen reduction technologies (prt) provide a preventive approach to a wide range of transfusion-transmitted infectious diseases. to date, prt widely used for platelet concentrates and blood plasma, however, the use of these technologies for the treatment of red blood cell-containing blood products undergo research. aims: the aim of our study was to evaluate the safety and efficacy of transfusions of pathogen-reduced (test group) red blood cell suspensions (rbcs) and compare these data with gamma-irradiated rbcs (control group). methods: the technology based on the combined action of riboflavin and ultraviolet (mirasol prt, terumo bct, belgium) was used to reduce pathogens in whole blood. subsequently, the rbcs of the test group were derived from pathogenreduced whole blood. the control rbcs were irradiated at the gammacell elite (best theratronics, canada) at a dose of gray. all rbcs were used for transfusion for days from the harvest day. pediatric patients with various oncological and hematological diseases were randomized to groups of members in each group. the test group of patients received transfusions of a pathogen-reduced rbcs; the control group received transfusions of a gamma-irradiated rbcs. the next day after transfusion were assessed hemoglobin and hematocrit increment, the level of potassium and haptoglobin in the patients' serum, the frequency and severity of transfusion reactions. - days after the transfusion, the direct antiglobulin test (dat) was performed and after - days the indirect antiglobulin test (iat) was performed. the interval to the next need for transfusion was also evaluated. results: the increase in hemoglobin and hematocrit (p = . ), as well as the concentration of potassium (p = . ) and haptoglobin (p = . ) in the patients' serum after the transfusion did not differ between groups. none of the patients in both groups had hyperkalemia after transfusion. in each group, two patients had febrile non-hemolytic transfusion reactions of comparable severity (p = ). all dat and iat tests were negative in both groups. the interval between transfusions were not significantly different between groups (p = . ). only in the test group was found the correlation between the increase in the hemoglobin and hematocrit values with the volume of transfusion, with the dose and the adjusted dose of hemoglobin obtained for the transfusion on body weight. and in this group was found inverse correlation between the hemoglobin and hematocrit increment with the level of hemolysis in the rbcs. summary/conclusions: we found that the clinical efficacy and safety of rbcs of the compared groups did not differ. there was no evidence of immune elimination and allo-sensitization caused by pathogen-reduced rbcs. according to our data, the spectrum of efficiency and safety indicators of pathogen-reduced rbcs is no worse than that of gamma-irradiated rbcs, provided that rbcs is used for days of storage. the founded correlation suggests that the efficiency of pathogen-reduced rbcs transfusions is more dependent on the characteristics of the rbcs. background: patient blood management (pbm) programs are expanding at an international level. a recent nationally representative study from united states observed pediatric age group as the only age group showing lack of objective evidence of pbm initiatives (goel et al, jama ) . aims: this study aims to identify trends in peri-operative blood utilization in children undergoing elective and non-elective surgeries over years duration from to . methods: using years data ( ) ( ) ( ) ( ) ( ) perioperative transfusions decreased steadily per year from . % in to . % ( % cumulative decline) in for children of all ages (or . ; % ci . - . ; p trend < . ). the cumulative change in elective procedures was . % versus . % decrease in urgent/emergent procedures (p trend < . ). summary/conclusions: in this large prospective registry study of > , children undergoing elective/non-elective surgeries, a statistically significant decrease in utilization of peri-operative rbc transfusions was seen across years from through with more significant decrease in urgent/emergent procedures than elective procedures while these findings need evaluation for non-surgical indications of transfusion, these results may provide first evidence of peri-operative pediatric patient blood management strategies being implemented to optimize transfusions in pediatric population. adverse events -tti, immune interactions and risk c-s - transfusion-transmitted infections (tti) are a long-standing and well recognized concern in medicine, which is tackled on the highest level to guarantee the safety of the transfusion procedure for all stake holders. these include the recipient patients, the donating volunteers, the health care workers involved, and their respective contact persons. accordingly, current national and international guidelines including expert societies and the who provide medical, technical, and legal frameworks, which are the basis for the standard operating procedures. nevertheless, there are important challenges, which render tti a "moving target", and reflect the dynamics in three main areas. first, a change in the type and number of recipient patients with past or ongoing immunomodulatory / immunodeficiency component (examples being hiv/aids, sot, allogenic hct, monoclonal antibody therapies, small molecule inhibitors). second, changing exposure to known agents in donors due to global travel, migration and displacement, as well as environmental/climate change. third, discovery and diagnostics of old and new agents with their known or presumed impact as tti. these aspects will require careful review of data and studies, and judicious discussion of the potential action such as selection versus close monitoring to keep tti rates as low as possible, to deliver maximal safety of patients and stakeholders. background: the implementation of nucleic acid testing (nat) and the development of sensitive and specific serologic assays to detect hbsag and anti-hbc antibodies significantly reduced the risk of hbv transfusion-transmission. the apparent redundant testing for two direct viral markers prompted debates on maintaining hbsag screening, particularly in low endemic countries where blood donations are screened for anti-hbc. however, frequencies of - % of hbsag-confirmed positive/nat negative donations have been reported depending on the sensitivity limit of the molecular assays used. the nature of this discrepancy between hbsag and dna remains largely unknown and it is essential to evaluate any potential negative impact on blood safety before considering removing hbsag testing. aims: the prevalence in blood donors and the molecular mechanisms responsible for a persistent undetectable or barely detectable level of viral replication in the presence of a sustained hbsag production were investigated in a collaborative study including five laboratories/blood centers in europe and south africa. discrepancy between viral dna and hbsag levels suggested the presence of mutations that may negatively affect hbv replication and/or infectious viral particle production. methods: donor samples from france, south africa, poland, and croatia were selected for having hbsag levels ≥ iu/ml and being id-nat (procleix-ultrio plus tm [ % lod: iu/ml]) non-reactive/non-repeatable reactive (nr/nrr) with undetectable viral load (vl) or < iu/ml (n = ) or nat repeat reactive (rr) with vl < iu/ml (n = ). french samples initially tested nat nr/nrr with procleix-ultrio (lod %: iu/ml) were retested with ultrio plus prior inclusion in the study. hbv dna load was quantified (cobas taqman hbv [loq: iu/ml]). hbv dna was purified from to ml of plasma after ultracentrifugation. the whole hbv genome, pre-s/s, precore/core and bcp regions were amplified and sequenced. results: following viral concentration, hbv dna presence was confirmed in % of all samples with undetectable or vl < iu/ml. hbv genotypes were a ( . %), a ( . %), a ( . %), b ( . %), c ( . %), d ( %), and e ( %). all samples were anti-hbc positive and % of ultrio-negative samples tested positive with ultrio plus. unusual - nt insertions/deletions identified in bcp regulatory elements (tata boxes, pginr, epsilon domain) suggest altered viral replication. amino acid substitutions (n = ) or deletions (n = ) at positions reported involved in nucleocapsid formation, particle envelopment and virion formation were observed in the core protein of samples. the replicative properties of the bcp and core variants are currently evaluated in vitro as a surrogate model for direct infectivity testing. preliminary results indicate that the variants tested so far have replicative capabilities similar to those of control viruses. analysis of pol, s, and hbx proteins is ongoing. summary/conclusions: these data confirmed the presence of extremely low level of circulating dna-containing viral particles in id-nat non-reactive or nonrepeated reactive blood donations with concomitant high hbsag levels and anti-hbc reactivity. despite the presence of mutations in the viral genomes potentially affecting virion production, preliminary data indicate that some of the viruses in plasma retain the ability to replicate in vitro and to constitute a potential infectious risk. c-s - background: in switzerland highly sensitive nucleic acid screening in an individual donation format for hepatitis b virus (hbv id-nat) and hepatitis b surface antigen (hbsag) detection is mandatorily performed (guidelines of swiss transfusion src, switzerland). since , hbv (hb) vaccination is recommended in switzerland for children and adolescents until the age of and for adults belonging to known risk groups. aims: to highlight that low anti-hbs titers several years following hbv vaccination still confer protection and enable the host immune system to clear hbv dna without development of serologic markers of disease. methods: a retrospective donor interview was conducted to complete information not covered by the questions included in the standard donor questionnaire. routine hbv serological donor screening was performed on a quadriga system (diasorin, former siemens) with the enzygnost hbsag assay (diasorin, former siemens). further hbv tests were performed on the abbott architect i analyser (hbsag neutralisation, hbeag, anti-hbc igg/igm, anti-hbc igm, anti-hbe and anti-hbs). routine id-nat screening for hiv/hcv/hbv was performed with the roche cobas mpx test on a roche cobas platform. hbv id-nat positive samples were confirmed with a quantitative hbv nat assay (abbott). background: hepatitis b core-related antigen (hbcrag) is a structural antigen of hbv, consisting in hbcag, hbeag and the p cr precore protein. quantitative hbcrag measurement is a sensitive marker of viral replication reflecting the cccdna content and persistence of disease. hbcrag positivity was found to be a significant risk factor of hbv reactivation in hbsag-, anti-hbc+, hbv dna-patients (occult hbv infection, obi) undergoing immunosuppressive therapy. aims: no data about hbcrag status in apparently healthy subject with obi are available. the aim of this study was to analyse this marker in our cohort of obi blood donors. methods: hbcrag was measured in blood donors confirmed to be carriers of obi (hbsag-, hbv dna+). of them, / ( . %) donors were anti-hbc positive, and ( . %) negative. donors had both anti-hbc and anti-hbe reactivities. a group of young blood donors vaccinated for hbv infection (hbsag-, hbv dna-, anti-hbc-), and patients with chronic hbv infection (hbsag+, hbv dna+) were used as negative and positive controls group, respectively. serum hbcrag was measured using a chemiluminescent enzyme immunoassay on the lumipulse g automated analyzer (fujirebio, tokyo, japan). the lower limit of detection (lod) of the quantitative assay is logu/ml and the lower limit of quantification (loq) is > logu/ml, due to nonlinearity results between and logu/ml. levels of hbcrag were tested in the three groups and analysed in comparison to the presence of anti-hbc and anti-hbe. statistical analysis was performed by the ibm statistics spss . . . results: all donors in the negative control group had undetectable hbcrag levels, whereas all patients in the positive control group have detectable hbcrag (mean value: . logu/ml, range . - . ), confirming that individuals without prior exposure to hbv would not have detectable hbcrag. hbcrag was detectable in / obi donors ( . %), with a mean value of . logu/ml (range . - . ). hbcrag could be measured only in obi donors ( . and . logu/ml), being below the loq of the test in the majority of obi ( / ). considering the presence of anti-hbc, hbcrag was detected in / ( . %) anti-hbc+ and in / ( %) anti-hbc-obi, with no significant difference in their mean levels ( . ae . vs . ae . ; p = . ). interestingly, the presence of anti-hbe ( / ) was independently associated with higher hbcrag levels ( . ae . vs . ae . ; p = . ). summary/conclusions: identification of donors with obi is critical to prevent the risk of hbv transfusion-transmission. being hbcrag associated with the cccdna content and replication, our results suggest that the presence of hbcrag, even if not quantifiable, could be useful marker to confirm the occult infection status, even in anti-hbc negative donors. the association between hbcrag, anti-hbc and anti-hbe could also be a useful marker to identify obi donors with a higher risk of hbv reactivation. c-s - hc group. human peripheral blood mononuclear cells (pbmcs) from blood donors were stimulated with hbv polypeptides pool in vitro. t cell proliferation assays (cfse) was used to detecting t cell proliferation, enzyme-linked immunospot assay (elispot) was used to detecting the frequency of hbv-specific ifn-c secreted t cells. spss . statistical analysis software was used for statistical analysis. the measurement data of normal distribution were tested by two independent samples t test; and the comparison between multiple groups was analyzed by one-way anova. mann-whitney u test was used for comparison between non-normal data sets. p < . was considered statistically significant. results: . proliferation characteristics of t cells. the proliferation of cd + t lymphocytes was mainly stimulated by specific hbv polypeptide pool, and the proliferation rates of obi group and chb group were significantly higher than those of hc group ( . %, . % vs. . %), with significant difference ( . % vs. . %, p = . , . % vs . %, p < . ). . the frequency of specific ifn-c secreted t cells. the response intensity of the obi group ( sfc/ pbmcs) and chb group ( sfc/ pbmcs) was higher than that of the hc group ( sfc/ pbmcs) under the stimulation of hbv polypeptide pool, and the positive rate of t cell response to the stimulation of hbv polypeptide pool was the highest in the obi group ( . %). summary/conclusions: both obi and chb had higher rates of hbv-specific t effector cell proliferation and ifn-c secretion than the healthy control group. compared with the chb group, obi group had a higher positive rate of t cell response, which may be one of the causes of host immunity resulting in obi. further studies on other immune factors are required. background: western blood transfusion practices are currently changing due to various drivers such as blood management policies, ongoing technological developments, and new therapeutic options. in the netherlands, as in many high-income countries, these have resulted in a diminishing trend of red blood cells. therefore, it is important for blood bank management to anticipate the future demand of blood products for the sake of medium and long term decision making. to support this decision making, we have employed scenario development, which is used in many other sectors (such as finance and transportation) and can also be applied to blood transfusion. building upon a prior literature review and semi-structured interviews of international experts, we gathered experts together for scenario sessions to assess the opportunities and threats for sanquin's medium-term ( - years) strategy using an online platform and face-to-face discussions. aims: to assess for opportunities, threats, and the organizational implications thereof for the medium-term future of sanquin, the dutch national blood bank. methods: twenty-one multidisciplinary experts in blood transfusion agreed to participate and were separated into two groups for half-day interactive sessions. using an iterative process through an online platform, experts brainstormed opportunities and threats for sanquin, which were categorized into themes. these themes were ranked according to importance and certainty, and through consensus, experts chose two themes with high impact and high uncertainty. for these chosen themes, specific actions for the blood bank were listed to mitigate and/or enhance the threat or opportunity. discussions were ample throughout. results: with regards to opportunities and threats for sanquin's medium term strategy, experts brainstormed many ideas and categorized them under themes: political context/ changing legislation, novel products and alternative applications, donors, international markets, commercialization, digitalization, change in perceptions, research, demand, and organizational structure. after ranking for importance and certainty, six themes were chosen: change in perceptions, international markets, political context (opportunities), demand (opportunities), research (vulnerabilities), and donor (vulnerabilities). for each of these themes experts provided specific actions for the organizations to mitigate threats or stimulate opportunities accordingly. these actions included increased transparency and improved communication with the (donor) public, lobbying in political spheres, increased activities in educational institutes and large funding organizations, and creating and collaborating on novel blood products on an international level, to name a few. summary/conclusions: these results show that mapping and assessing a blood bank's future using a multi-disciplinary group of experts is conducive as an effective means of collection a diverse range of opportunities and threats. this provides an opportunity for blood bank management to become proactive towards these potential opportunities and threats and possibly evolve future strategies for the organization. showed that iron-deficient female blood donors were more likely to have depressive symptoms than non-iron deficient female blood donors. among participants with depressive symptoms, females with low plasma ferritin levels had significantly increased odds for reporting a "feeling of lacking energy and strength" (or = . ; % ci: . - . ). as it is known that blood donors are at an increased risk of iron deficiency, it is important to determine whether those genetically predisposed to lower plasma ferritin levels have a higher risk of experiencing the tiredness/lack of energy symptom. aims: to investigate whether there is an association between polygenic risk scores (prss) based on plasma ferritin levels and the tiredness/lack of energy symptom in blood donors. methods: the dbds is an ongoing nationwide blood donor cohort, of which genome-wide genotype data are available for , participants. genotyping was performed using the infinium global screening array (illumina â ) and imputation was achieved based on a scandinavian reference genome. ferritin prss, based on an icelandic ferritin gwas (n = , ), were calculated for all dbds participants. , female donors were available for the analysis. data on depressive symptoms were obtained using the validated major depression inventory scale (mdi), a selfreport mood questionnaire, which assesses the presence of depressive symptoms. a donor was classified as "tired" if they responded "all the time" or "most of the time" to the question "how often do you feel that you lacked energy and strength?". logistic regression analysis was performed, adjusting for age. for generating the quantile plots, the participants were distributed evenly into six quantiles based on their prs, whereby quantile contained the donors with the lowest prss (genetically predisposed to lower ferritin levels) and was set as the reference quantile with or = from the age-adjusted regression analysis (tiredness~quantile). results: prss in females ranged between - . and . (mean . ). a total of , female donors were classified as "not tired" and ( . %) were classified as "tired". no significant difference in ferritin prs was found between "tired" and "not tired" female donors (tired mean prs: . ; not tired mean prs: . ). an age-adjusted logistic regression model found this to be insignificant (or: . , % ci: . - . ), p = . ). to visualise the lack of association, a quantile plot was created, separating the female donors into six equal quantiles based on their prs. no clear trend was observed; donors with the highest prss (in quantile ) had or = . (p = . ) of being tired when compared to those in quantile (or set as ). summary/conclusions: no significant association was found between the ferritin prss of female blood donors and the tiredness/lack of energy symptom. further studies are needed to understand the effect of blood donation versus genetic constitution on tiredness among female iron-deficient blood donors. background: antiretroviral therapy (art) is critical for the control of clinical progression of human immunodeficiency virus (hiv) infections. however, the outcome of art could be limited by drug resistance-associated mutations (drms), even lead to the transmission of drug-resistant hiv to treatment na€ ıve patients such as blood donors, which is a huge concern to art. drms surveillance in hiv infected groups is strongly recommended by world health organization. characteristics of genetic diversity and drms of hiv among blood donors may provide comprehensive data to monitor viral evolution and optimize art, play important roles in blood safety. aims: limited data concerning the epidemic of hiv- subtypes and drms of blood donors is available in china. this study is to investigate genetic characteristics and drms of hiv- infected blood donors. methods: from - , blood donations collected from blood centers, covering almost the whole of china, were confirmed as hiv- positive by national centers for clinical laboratories using abbott realtime hiv- assay or cobas taq-man hiv- test, version . . then hiv- gag ( bp, hxb : - ), pol genes ( bp, hxb : - ) (encoding the whole protease (pr) and a part of reverse transcriptase (rt)) was sequenced after viral rna extraction and amplification. hiv- subtype based on gag and pr-rt regions was determined by comprehensive analyses of los alamos hiv blast tool, rega hiv- subtyping tool, phylogenetic trees and online jphmm program. drms analysis was performed in the stanford hiv drug resistance database. results: among donations, gag and pr-rt regions of samples were sequenced successfully. the distribution of hiv- genotype was as follows: crf_ bc = ( . %), crf_ ae = ( . %), b = ( . %), crf_ bc = ( . %), crf _ b = ( . %), crf _ b = ( . %), crf _cpx = ( . %), crf _ b = ( . %), crf _ = ( . %), crf _bc = ( . %), urf_ = ( . %) and urf = ( . %). of hiv- isolates were identified to have drms. there were ( . %, / ) protease inhibitors (pi) accessory drms, pi major drms and ( . %, / ) non-nucleoside reverse transcriptase inhibitors (nnrti) drms. most of blood donors with drms were crf _ae and crf _bc ( . %, / ). of pi accessory drms were q e. the pi major drms included m l, m i and n s. n s could result in hlr to atazanavir (atv) and nfv, llr to indinavir (idv) and saquinavir (sqv). v d/e is main nnrti drm ( . %, / ). a combination of v d and k r among two samples acted synergistically to reduce efavirenz (efv) and nevirapine (nvp) susceptibility. furthermore, two blood donors with k n mutation in reverse transcriptase gene had high level-resistance to efv and nvp. summary/conclusions: overall, the most prevalent subtypes among blood donors in the study were crf _bc ( . %), crf _ae ( . %). besides, other rare crfs and several urf_ and urfs were also found in these hiv- isolates, which suggested the epidemic of hiv has been shifted from high risk populations into general populations, including blood donors in china. drms were observed in . % donors in the study, which may result in resistance to pis and nnrtis, especially the hiv- variants with n s mutation in pr gene and k n mutation in rt gene. in summary, our findings indicate that increasing diversity of hiv- in blood donors and remind us the necessity of timely genotypic drug resistance monitoring and molecular epidemiology surveillance of hiv- among blood donors. background: labeling of platelets is required to measure the recovery and survival of transfused platelets in vivo. currently a radioactive method is used to label platelets. however, its' application is limited, due to safety issues and the inability to isolate transfused platelets out of the circulation. biotin-labeling of platelets is an attractive non-radioactive option, however, no validated protocol to biotinylate platelets is currently available for clinical purposes. aims: the aim of this study is to develop a simple, standardized, reproducible method to label platelets with biotin as a non-radioactive alternative to trace transfused platelets in vivo. methods: six pooled buffy coats derived platelet concentrates (pcs) stored in % plasma were biotinylated at day and day of storage. to distinguish the effect of the processing steps from the effects of biotin incubation, 'sham' samples were processed. for the biotinylation procedure, ml of pcs was washed twice and incubated with mg/l biotin, dissolved in phosphate buffered saline-pas-e ( : ), for min. stability of the biotin labeled platelets after irradiation was tested. annexin v and cd p expression were assessed as measures of platelet activation. applicability of this method to other platelet products was assessed in three pooled pcs stored in % pas-e and three single donor apheresis pcs. results: the method was reproducible performed in a closed system. after biotinylation, . % ae . % of platelets were labeled. platelet counts, ph and 'swirling' were within the range accepted by the dutch blood bank for standard platelet products. the number of annexin v positive cells was not significantly altered by the biotinylation procedure in both fresh and stored platelets. in contrast, cd p expression was increased in biotinylated platelets . % iqr( . - . %) compared to the control samples . % iqr( . - . %) on day of storage. however, biotinylated platelets were not more activated compared to sham samples % iqr( . - . %). thus only the procedural steps led to increased cd p expression and not the biotin label itself. all samples showed maximal response to thrombin receptor-activating peptide. for platelets labeled at day , a similar pattern was observed. irradiation of biotin labeled platelets did not alter the stability of the biotin label nor cell quality. furthermore this method is also applicable to pooled pcs stored in pas-e and apheresis pcs, with similar patterns in annexin v and cd p expression. summary/conclusions: we developed a standardized and reproducible protocol according to good practice guidelines (gpg) standards, for biotin-labeling of platelets for clinical purposes. the procedural steps, which are similar to the steps used for production of hyperconcentrated platelet products, led to an increased cd p expression, but did not alter the annexin v expression. this method can be applied as non-radioactive alternative to trace and recover transfused platelets in vivo. blocking activity over the prototypic chs insulator in cell lines and substantially reducing genotoxicity in a c-retroviral vector-mediated carcinogenesis mouse model. in contrast to chs , these insulators are small-sized ( - bp vs . kb) and can be easily accommodated in gt vectors without detrimentally affecting vector titers. aims: we aimed to test whether a , one of the newly discovered cis, could reduce vector-mediated genotoxicity in the challenging context of sin-lvs, by insulating a therapeutic globin-vector. methods: we tested the genotoxicity effect in the il- -dependent d cells, which upon transduction with oncogenic vectors become il- -independent, leading to transformation. d cells were transduced with sin-lvs: the b-globin-ΤΝs . . -, the insulated b-globin-a -tns . . and the oncogenic sffv-gfp-vector. transduced cells were expanded in % il- and transduction efficiency was determined by vector copy number (vcn). transduced d cells were seeded in methylcellulose with % or - % il- to detect the il- -independent and potentially transformed clones. the il- -independent clones were further expanded in % il- and infused in partially myeloablated and il- -treated c h/hej mice. wbc analysis, blood smears and bone marrow(bm) cytospins were performed. results: the a insulator did not negatively affect vector titers (ΤΝs . . , a -tns . . , sffv-gfp: . , . , . x ^ iu/ml, respectively). d cells were successfully transduced with all vectors (%vcn positive colonies: - %) and expanded up to -fold. the a -insulator decreased the number of il- -independent colonies by - % over the uninsulated vectors. the uninsulated vector-transduced, il- -independent colonies, were greatly expanded in culture with % il- over the a -transduced colonies (sffv, ΤΝs . . , a -tns . . : , , fold change, respectively). il- independence as a transformation event was confirmed in vivo by the development of overt leukemia (hyperleukocytosis, splenomegaly, bm-and extramedullary site-infiltration) in mice transplanted with the il- -independent and expanded colonies. summary/conclusions: under forced oncogenic conditions, the a insulator effectively protected a therapeutic vector from vector-mediated genotoxicity. a may serve as a safety feature in the construction of globin-sin-lvs. background: novel rare nucleotide substitutions are frequently identified in rhd, the gene encoding the immunogenic d antigen of the clinically-relevant rh blood group system, resulting in d variant phenotype. so far, it has been commonly accepted that substitutions of amino acids located either in a transmembrane or intracellular domain of the rhd protein induce weak d phenotype, i.e. reduced d antigen density at the surface of red blood cells. recently we showed by functional analysis using a "minigene splicing assay" (msa) that a decrease in d antigen expression may be due also to alteration of cellular splicing. aims: here we pay attention to the general disruption of this mechanism and the related phenotypic consequences in novel and previously reported single-nucleotide variations in rhd. we then sought to characterize functionally by msa novel candidate splicing variants in rhd. then we extended the project by studying prospectively all single-nucleotide variations reported in rhd exons, in order to assess globally the correlation between in silico prediction and functional analysis and to gain insights into the reliability of bioinformatics tools in line with the available phenotypic and/or clinical data. methods: seventeen novel or uncharacterized rhd variations, including missense, synonymous and intronic substitutions, were selected for functional analysis by msa in human cell models. a second set, including missense variants reported in rhd exons and , was further analyzed. functional data were compared with an algorithm derived from the quepasa method and tools available in the alamut suite. a published d protein model was used to visualize the location of missense amino acid substitutions and to assess potentially their respective phenotypic consequence. results: a novel "universal" minigene was validated and used successfully to characterize eleven novel splicing variants. those variants include six intronic and four missense substitutions close to the consensus dinucleotide splice sites, as well as the c. c>t synonymous variation associated with a weak d phenotype, which creates a de novo splice site. very interestingly, c. g>t (gly val; d-negative) disrupts totally normal splicing, while c. g>c (gly ala; weak d) and c. g>a (gly asp; d-negative) only partially alter the mechanism. further visualization of amino acid changes in a d model suggests that gly asp, but not gly ala, dramatically impair rhd protein structure/folding. subsequently the global analysis of mutations in rhd exons and by msa showed that inclusion of whole exon sequence in the mature transcript is significantly reduced in / ( . %) variants, which correlates well with the quepasa-like prediction (sensibility = . , specificity = . ). additionally, while normal exon inclusion is affected by c. c>g (weak d type ), the associated leu val substitution does not seem to be deleterious to the protein. summary/conclusions: on the basis of our functional data, this work shows that splicing disruption in the presence of rhd variants is a common and general mechanism that may act independently or synergistically with alteration of protein structure through amino acid substitutions, resulting in a weak d phenotype. it also illustrates the potency of combining functional tests and in silico tools towards the phenotypic/clinical interpretation of rare variants. background/aims: monetary and non-monetary incentives may support blood services in recruiting blood donors but have also been criticized for violating ethical principles and threatening blood safety by attracting donors with a high risk for infectious diseases. although incentives for blood donors have been discussed extensively over the past decades, empirical research on this topic remains limited. the aim of this study was to describe attitudes towards incentives for blood donors in europe and show donor return rates of compensated and non-compensated blood donors in south-west germany. methods: first, we present results of a secondary analysis of the eurobarometer, a nationally representative survey in all member states of the european union. in , participants were asked to evaluate eight potential incentives for blood donations as acceptable or unacceptable. these incentives were refreshments (e.g. coffee), physical check-ups (e.g. blood pressure), free (testing) laboratory parameters, free medical treatment, complimentary items (e.g. first aid kits), monetary travel reimbursements, additional cash reimbursements, and release from work. second, we conducted a retrospective analysis of donor return patterns of . compensated and . non-compensated donors who started donating blood at mobile and fixed donation sites. compensated donors received either eur as a regular reimbursement for their expenses (at a fixed donation site), in accordance with the german transfusion law, or a singular free entrance for an amusement park (at a mobile donation site). these compensated donors were compared with noncompensated donors who started either at a fixed or mobile donation site. chisquare statistics were used to test for differences in regular donor status after , , and months between compensated and non-compensated first-time donors. results: among german participants of the eurobarometer, physical check-ups ( . %), refreshments ( . %) and free (testing) laboratory parameters ( . %) showed the highest acceptance as an incentive for blood donors. travel reimbursements and free medical treatment were rated as acceptable by . % and . %, respectively. the lowest acceptance was for release from work ( . %), complementary items ( . %) and additional cash reimbursement ( . %). interestingly, the acceptance of potential incentives varies considerably across europe. in south-west germany, donor return of first-time donors differed significantly by type of compensation. among compensated first-time donors, who received eur as a monetary reimbursement, the proportion of regular donors after months ( . %) was significantly higher than among comparable non-compensated donors ( . %). however, a non-monetary compensation (free entrance) did not increase donor return rates. conclusion: the eurobarometer survey indicates that in most european countries monetary incentives are only accepted by a small minority. refreshments, checkups, free (testing) laboratory parameters and free medical treatment were most popular as incentives for blood donors. however, results of our four non-randomized donor samples from south-west germany suggest that monetary compensation may increase the likelihood of donors returning to fixed donation sites. regular monetary reward may therefore help to recruit regular donors especially in urban settings. incidentally, non-monetary compensation by a free entrance, however, may not affect donor return. background: previous research showed that whole blood (wb) donors that are temporarily deferred on-site are at higher risk of lapsing, yet very little studies have focused on differentiating the effects that different deferral reasons (e.g., travel, hemoglobin [hb]) may have on donor lapse. in addition, donor experience (i.e., firsttime or repeat donor) has also previously been found to affect donor lapse, yet novice ( - prior donations) and reactivated donors (returning after years of not donating) may respond differently. finally, it is currently unclear how and why different deferral reasons and donor experience interact in influencing donor lapse. aims: our aims were to understand ) how deferral reasons and donor experience jointly affect donor lapse, and ) why donors may lapse after temporary deferral. methods: a mixed methods approach was used. first, we used sanquin's donor database for a quantitative analysis of return behavior of all dutch wb donors between and (n = , ). the first wb donation for each donor was identified as the target donation. lapse was defined as non-return within a followup period of two years after the target donation. target donations included % new donors, % novice donors, % experienced donors, and % reactivated donors. deferral reasons included travel, hb, medical short-term (< days duration), medical long-term (> days duration), and miscellaneous. next, we interviewed temporarily deferred donors to understand the deferral process from their perspective. semi-structured interviews were used to understand how these donors cognitively and emotionally experienced on-site temporary deferral. we analyzed the interviews (using the framework approach, cf. hillgrove et al., bmc public health, ) to identify key topics and underlying themes. results: of target donations, % were deferred, mostly for travel ( %), medical short-term ( %), and hb ( %). survival and time-to-events methods showed that the different deferral reasons and donor experience levels differentially impacted donor return or lapse. importantly, experience and deferral interacted in influencing return (rate). for instance, deferred new donors were more likely to lapse than eligible or experienced donors (ors < . , p's< . ). even though deferral also affected return of experienced donors, this effect was smaller or even non-existent for certain deferral reasons (e.g., travel-and hb-related deferrals). qualitative results showed that almost all donors experienced temporary deferral as disappointing, particularly when it was unexpected (e.g., first-time deferral). not all donors (fully) understood the aims of deferral or how to prevent on-site deferral. donor beliefs about why deferral would lead to lapse were related to recurring deferrals, (mistakenly) interpreting deferral as permanent, or feeling all the effort did not pay off. summary/conclusions: reasons for temporary deferral differently impact risks of donor lapse at different levels of donor experience. for new donors all reasons for deferral are related to higher risks of lapse, whereas some reasons for deferral seem not to affect lapse among more experienced donors. unexpected or recurring deferrals may explain why donors lapse after temporary deferral. blood banks may tackle disappointment after deferral by explicitly showing that the donor is still valued, for instance by using personalized communication or offering an alternative good deed. background: blood donors experience a temporary reduction in their hemoglobin (hb) value after whole blood donation. in the netherlands, the hb value is measured before each donation, and a too low hb value (cut-off values: . mmol/l ( g/l) for men and . mmol/l ( g/l) for women) leads to a deferral for donation, in order to prevent iron deficiency and anaemia. the minimum interval between two donations is internationally set at weeks, but over time donors exhibit iron deficiency so that blood donors are temporarily deferred from donation each year. in the us % - % of deferrals are due to low hb, especially in women (editorial, transfusion, ) . due to the recovery process after each donation and the unobserved heterogeneity of donors, advanced statistical methods are needed to model the longitudinal data of hb values of blood donors. aims: to estimate the shape and duration of the recovery process of hb until the hb value has returned to its pre-donation level, to assess whether one can distinguish between donors with fast and/or slow recovery of their hb level and to predict future hb values. methods: the study is based on data of the donor insight study, which was a prospective cohort study performed by sanquin in the netherlands from to . we employed three statistical models for the hb value: (i) a mixed-effects models, (ii) a latent-class mixed effects model, and (iii) a latent-class mixed-effects transition model. in each model, a flexible function was used to model the recovery process after donation. the latent classes identify groups of donors with fast or slow recovery times, and donors whose recovery time increases with the number of donations. the transition effect accounts for possible state dependence in the observed data. all models were estimated in a bayesian way, using data of a sample of new entrant donors ( males and females). prior information from the clinical literature (boulton, vox sanguinis ) about the recovery process three days after blood donation was incorporated into the analysis since these values were not identified in the observed data. results: the results show that the latent-class mixed-effects transition model fits the data best. we also found that the recovery process shows a concave process (initially fast followed by slower recovery). the estimated recovery time is much longer than the current minimum interval of days between donations. namely, depending on the subgroup that the donor belonged to, males showed a recovery time of to days, while the estimated recovery time for females varies between to days. these results suggest that an increase of this interval may be warranted. summary/conclusions: the analysis shows the usefulness of the sophisticated statistical models that make use of historical information to model complex processes in time, in this case the hb trajectory over time across repeated donations. in addition, our results suggest a (much) longer time lag between subsequent donations to avoid anemia. background: complications of blood donation are known to reduce donors' return for future donation. the episode study (experience success in donation) showed that water drinking shortly before donation had an effect of % reduction of selfreported vasovagal reactions (vvr) in younger novice whole blood donors (wiersum-osselton, transfusion, ) . aims: in this study we analysed the return for a subsequent donation of the donors participating in the episode study. this was a predefined secondary outcome of the episode study. methods: the episode study was conducted in young (< years) whole blood donors making their first, second, third or fourth donation in geographically selected collection centres. the study interventions were: ml water drink, ml water drink or squeezing a ball (placebo intervention) during the wait after the screening interview and before phlebotomy, and a control group without intervention. participating donors were sent an online questionnaire about their experience within a week following their donation attempt. in the netherlands donors are usually invited for blood donation in accordance with hospitals' needs; the aim is to invite eligible donors at least once a year. donors were included in the return analysis if they had received at least one invitation within days after the index donation and we analysed their return for a donation attempt within days. associations with the interventions and donors' donation status, gender and reported symptoms at their index donation were analysed by calculating return percentage of eligible donors and by binomial logistic regression. results: out of the episode participants who had received an invitation, ( . %) returned within the study period. there was no difference in donor return between the two water groups. the likelihood of return was significantly increased in both water and placebo intervention donors compared to the questionnaire group (or . , % ci . - . and . , . - . respectively). return was slightly lower in women (or . , ) and lower in first-time donors (or . , . - . ) than after a nd - th donation. a staff-recorded or self-reported vvr at the index donation reduced donor return (or . , % ci . - . and or . , . - . respectively). other symptoms following donation were also associated with a lower return percentage. summary/conclusions: in this cohort of younger new and novice blood donors, . % returned for a subsequent donation. a vvr (either staff-recorded or selfreported) reduced donor return. donors who received a study intervention, either water or placebo, were more likely to return, whether or not they had suffered a vvr. it is conceivable that the mere fact of study participation could also have increased donor return, even in de questionnaire group; this will be examined in the total population of target group donors. background: the contribution of older blood donors to the blood supply is substantial. in australia, donors aged > years contributed % of all donations made in . however, with ageing, the general health status of older donors changes relatively faster, thus progressively affecting their ability to donate. an indepth understanding of the relationship between older donors' health status, future donation patterns, and risk of iron-deficiency could be of a great value to inform the blood service to predict the number of future donations, and manage the risk of iron-deficiency. aims: to understand the relationship between self-reported health, blood donation patterns, and the management of identified iron-deficiency in older blood donors. methods: we linked the sax institute's and up study baseline data collected between and to the blood service donation records, inpatient records, and medicare records*. the data-linkage was conducted by centre for health record linkage. using these linked data, we examined the relationship between health, donation patterns, and iron-deficiency and its management. results: we followed up , active whole blood donors for , eligible person-years (average age at recruitment . years, . % female, average follow up . years per-person). after adjusting for the effect of age, sex, body-mass index, education, non-english language spoken at home, country of birth, smoking, physical activity, regular use of multivitamins, alcohol consumption at enrolment, and total number of whole blood donations in the years prior to enrolment, participants with better self-reported health at recruitment showed significantly higher rates of donation. excellent, very good, good, and fair/poor health status donors made ( % ci - ), ( - ), ( - ), and ( - ) donations per person-years, respectively. iron-deficiency was identified in . % of donors in the study (n = , % ci . - . ) . sixty percent of those with iron deficiency (n = , , % ci . - . ) visited their general practitioner (gp) within days of the identification of irondeficiency, and . % ( % ci . - . ) of those visiting gp underwent further iron status examination and monitoring. after adjusting for several potential confounders including the total number of donations made during the follow-up period, excellent self-reported health status was independently associated with lower risk of iron-deficiency (p for trend = . ). summary/conclusions: information on self-reported health status can be an effective indicator to estimate the future donation yield of an older blood donor panel, and risk of developing iron-deficiency. donors with better self-reported health had a higher number of future whole blood donations and a lower risk of iron-deficiency. donors referred to gps for management of their iron status utilised the health services as expected, however there is an opportunity to improve their contact with their gps. * medicare records was provided by australian government department of human services. anaemia is a major public health issue, affecting % of the population worldwide according to the world health organization. iron deficiency is responsible for approximately half of all cases globally, with other causes including anaemia of chronic disease, other nutritional deficiencies, haemoglobinopathies, renal impairment, malignancy and bone marrow disease. in the elderly, where anaemia is even more common, the cause is frequently multifactorial. anaemia is associated with increased mortality, decreased cognitive and physical function, depressive symptoms and fatigue, particularly in older adults. poor outcomes have also been reported in anaemic patients with underlying comorbidities such as cardiac and renal disease, and cancer. within a hospital setting, anaemia is highly prevalent. preoperative anaemia, affecting up to % of patients, is associated with poor clinical outcomes including higher in-hospital mortality, longer length of stay and higher icu admission rates. anaemia management requires a proactive and multi-faceted approach, typically involving a multi-disciplinary team in which the transfusion practitioner plays a vital role. this includes screening of high-risk patients and pre-admission clinics to identify and manage patients at high risk of peri-operative anaemia. implementation of patient blood management (pbm) guideline recommendations has been shown to be effective to prevent and optimally manage anaemia within the community and hospital settings. the transfusion practitioner has key roles in the coordination, monitoring and auditing of pbm programs. active patient involvement and engagement of all members of the multidisciplinary team, including primary care clinicians, are also key to enhance the success of such programs. tp - the role of the transfusion practitioner in anaemia assessment and management: processes, tips and resources for creating background: patient blood management (pbm) is an evidenced based integrated multi-disciplinary approach aimed to improve clinical outcomes by effectively managing and conserving the patient's own blood, thus reducing unnecessary exposure to transfusion. pbm has the patient as the central focus with the aim being to improve their outcomes and include them in the process. pbm includes three pillars: ) optimising the patient's own blood, ) minimising blood loss and ) optimising a patient's physiological tolerance of anaemia. delayed assessment/management of anaemia contributes to increased health costs and unnecessary blood transfusions, and transfusion has been recognised to be associated with increase morbidity and mortality. the term transfusion practitioner (tp) includes those known as transfusion nurses, transfusion safety officers, haemovigilance officers, or patient blood management (pbm) coordinators. a key aspect of the role is driving and influencing clinical blood management activities to help align practice to internationally recognised guidelines and standards, including pbm. aim: to demonstrate the tp role in anaemia assessment & management and discuss strategies, processes, tips and resources for creating organisational and cultural change to implement pbm. context: literature outlines the importance of a multidisciplinary team to implement pbm related changes, and tps play a fundamental role within these teams to support 'buy in'. tps are seen as enablers, pulling resources together, engaging with those involved, providing education and facilitating change. they are often the ones to conduct audits, collating data and evaluating outcomes. approaches to implement pbm should be tailored to suit individual organisations. the authors will outline different approaches, highlighting where the tp can support or lead activities. one approach to anaemia assessment is to undertake an audit, examples of available tools will be shown. with this data, the tp along with the pbm team can explore options for corrective action. these could include interventions such as developing a pathway where all or a specific group of patients are assessed and or treated either at a preoperative clinic, or with their local general practitioner; through to more complicated strategies such as establishing anaemia clinics. the skills of the tp are a valuable asset to analyse clinical specialties/patient mix who should be targeted to achieve best outcomes, they know the organisation and as such are well placed to help develop a process/concept that will suit, and they can provide education and support to promote and embed these practices. conclusion: appropriate assessment and management of anaemia requires a multidisciplinary approach. the tp plays an active and crucial role in this team. examples of processes, tips and resources to support change and embed a pbm culture across the clinical spectrum will be shared. d-s - department of hematology and central hematology laboratory, inselspital bern, bern, switzerland immune haemolytic anaemia (iha) is characterized by an increased breakdown of red blood cells (rbcs) due to allo-and/or autoantibodies directed to rbc antigens with or without complement activation. clinical and laboratory signs of haemolysis in concert with the presence of a positive direct antiglobulin test characterize iha. alloantibodies formed during pregnancy and/or after prior transfusions may cause acute or delayed haemolytic transfusion reaction after transfusion of a rbc product incompatible with the specificity of the alloantibody. autoantibodies to rbcs reduce the survival of endogenous and hamper the recovery of donor rbcs after transfusion. lymphoproliferative disease, autoimmune disease, infection or drugs often cause autoantibodies to rbc, but frequently no obvious cause can be identified. besides the antigen specificity, the isotype critically determines the biological activity of rbc antibodies in vivo. the isotype defines the affinity to fc-gamma receptors on cells of the reticuloendothelial system as well as the capacity to activate the classical pathway of complement, igm being the most effective. antibody-mediated complement activation results in the opsonisation of rbc with c bc/c d with subsequent complement receptor-mediated removal by phagocytes (extravascular haemolysis). occasionally, complement activation proceeds via the activation of c to the formation and insertion of the membrane attack complex resulting in intravascular haemolysis. there is growing evidence that the innate immune system plays an important role in the pathogenesis of iha. the process of complement-mediated haemolysis results in systemic inflammation, which contributes to morbidity and mortality of patients suffering from iha. complement activation results in the release of anaphylatoxins, which are strongly vasoactive and mediate chemotaxis, inflammation and formation of radical oxygen species. release of cell-free haemoglobin and cell-free haeme upon haemolysis induces endothelial cell activation, no-depletion, cytotoxicity, ros formation and neutrophil activation. natural plasma scavengers, such as haptoglobin and hemopexin complex with their target molecules, cell-free haemoglobin and haeme, with subsequent removal of the complexes via cd and cd -mediated phagocytosis. although being positive acute phase proteins due to consumption the plasma scavengers become exhausted during chronic haemolysis thereby failing to prevent the adverse biological effects of cell-free haemoglobin and haeme in the circulation. inducible haeme oxygenase- (ho- ) is an efficient cellular scavenger by breaking down haeme into biliverdin with subsequent formation of bilirubin, co and ferrous iron with subsequent oxidation to ferric iron and storage by the ferritin h chain. ho- has an established role in the systemic protection from systemic inflammation induced by haemolytic and non-haemolytic diseases. the lecture will emphasise the role of innate immunity with a special focus on different plasma-and cellular systems involved in the pathogenesis of systemic inflammation in patients suffering from iha. d-s - understanding erythrocyte clearance c roussel, p amireault, p ndour and p buffet research and teaching, institut national de la transfusion sanguine, paris, france the clearance of erythrocytes is essential in physiology, disease and transfusion. elimination of erythrocytes altered because of senescence or pathological processes is expected to protect the microcirculation from obstruction by adhesive or rigid erythrocytes. it also contributes to the harmful consequences of anemia and hemolysis in hereditary and acquired red blood cells diseases as well as in conditions associated with auto-or allo-immunization. immunobiology has explored in great details antibody-mediated clearance of erythrocytes but conventional approaches may not be fully operational to explain delayed hemolytic transfusion reactions. some important clearance processes are independent from the recognition of molecules or antigens on the erythrocyte surface. increased erythrocyte stiffness triggers their clearance in hereditary spherocytosis, malaria and possibly also in the context of autoimmune anemia. knowns and unknowns on the mechanisms and sites of erythrocyte clearance will be presented based on a critical review of old and recent contributions. d-s - cardiovascular and endocrine-metabolic diseases and aging, istituto superiore di sanit a, rome, italy existing literature indicates that red blood cells (rbcs), beyond gas transport, exert a complex role in human physiology, being involved in many functions essential to maintain ion, metabolic and immunological homeostasis. rbcs display an immunomodulatory activity on adaptive immune cells by promoting t cell growth and survival and inhibiting activation-induced cell death. the balance between cell death and survival controls t cell homeostasis and anomalies in this balance account for diseases linked to excessive or faulty t cell growth. rbcs are able to modulate innate immunity by binding endogenous molecules such as chemokines and mitochondria-derived dna, as well as external agents such as pathogens. rbcs can also directly modulate innate immune cell activation or tolerance by controlling the maturation of the circulating pro-inflammatory subset of dendritic cells (dcs). these cells are potent inducers of primary antigen-specific t cell responses, produce tnf-a when stimulated by lps and are the principal il- p -producing cells among leukocytes. the pro-inflammatory capacity of circulating dcs is controlled by rbcs that are able to inhibit their maturation and il- production. in diseases characterized by local th inflammatory response such as psoriasis vulgaris and rheumatoid arthritis, pro-inflammatory dcs play a role in the induction and perpetuation of inflammation. collectively, literature data indicate that rbcs exert important modulatory functions that may result in immune activation or quiescence, depending on the environmental conditions. when rbcs encounter a microenvironment characterized by an intense production of ros, the rbc defenses get overwhelmed or are unable to counteract the new pro-oxidant status and become themselves a source of ros, which cause the generation of senescent signals on rbcs. the major feature of oxidized rbcs is the clustering and/or the breakdown of band . other features are the complexation of hb with spectrin, the loss of glycophorin a, the externalization of phosphatidylserine and the reduction of the "marker of self" integrin-associated protein cd . a similar senescence phenotype has been documented in rbcs during the storage period. oxidized, senescent or stored rbcs, due to surface antigen modification and to the release of pro-inflammatory molecules, fail to control immune cell homeostasis thus contributing to the perpetuation of inflammation and to the pathogenesis of immune-mediated diseases associated to oxidative stress, such as autoimmune diseases and atherosclerosis. our research group demonstrated that rbcs from patients with carotid atherosclerosis presented a senescent phenotype similar to that acquired by rbcs from healthy subjects following to in vitro oxidation. oxidized erythrocytes fail to control t lymphocytes apoptosis and lipopolysaccharide-induced monocyte-derived dc maturation, thus representing dangerous signals for adaptive and innate immunity and contributing to the pathogenesis of atherosclerosis. in conclusion, the crosstalk between rbcs and the immune system represents a mechanism to maintain immunological homeostasis. however, in high oxidative stress conditions, that can take place during a prolonged storage period or in particular diseases, rbcs can acquire a pro-oxidant behaviour and lose their functional and homeostatic features. by interfering in immune system homeostasis, rbcs become a potential tool that can be manipulated to improve or reverse pathological situations characterized by anomalies in the control of adaptive and innate immunity. transfusion therapy remains an important treatment modality for patients with sickle cell disease (scd). transfusions are given to lower the percentage of circulating sickle rbcs, and to decrease blood viscosity and have been shown in clinical trials to reduce the risk of stroke by %. however, many indications for transfusion in scd remain controversial partly due to insufficient randomized clinical trials data and in part because of our limited understanding of the complex pathologic networks leading to diverse disease complications in scd despite the common single mutation. similarly, we have incomplete mechanistic understanding of why chronic transfusion protocols must be continued for those indications supported by clinical data. the beneficial effects of transfusion therapy in scd need to also be weighed against potential transfusion risks including alloimmunization associated with lifethreatening delayed transfusion reactions, increased iron stores associated with increased oxidative stress and exposure to infectious agents. we believe that a deeper understanding of the benefits as well as harmful effects of transfusions is crucial to optimize our current transfusion therapy protocols in scd. this knowledge may provide highly needed guidance, which is currently lacking, for expansion or limiting existing indications for chronic transfusions in scd. d-s - treatment of thalassaemia department of pediatric hematology, ege university, faculty of medicine, bornova/ izmir, turkey thalassaemia is a devastating blood disease with a significant worldwide burden. annually, , children are born with a major thalassemia. life-time rbcc transfusions and iron chelation remain standard of care treatment in thalassaemia. transfusion therapy still account for significant iron overload related morbidity and mortality despite chelation therapy which is associated with poor adherence, safety concerns and varied efficacy. higher risk for transfusion transmitted infections (ttis) exists for thalassemia patients whose transfusion exposure sustains lifelong. although, the risk of transmission for traditional viruses is exceedingly rare in the modern era, emerging infectious diseases continue to be recognized as potential threats to transfusion safety. the inadequacy of blood safety points to the necessity for an additional layer of security for the blood supply in the developing world. pathogen reduction technologies for rbcc may imply a proactive, more generalized approach against new and re-emerging pathogens in the developed world and may be an ultimate safeguard for transfusion safety in the developing countries. rbc alloimmunization may become a major challenge in thalassaemia management. prevention is the key reducing the burden of alloimmunization. while the recommendation is to transfuse thalassaemic patients with c/c,e/e,kell compatible blood, it is not universally practiced. extended molecular rbc typing may be an appropriate adjunctive test in addition to serological typing before embarking on transfusion therapy. if a complete rbc antigen profile has not yet been performed in an alloimmunized patient, genotyping is the only option for accurate detection of rbc antigens that may guide the antibody identification. allogeneic stem cell transplantation (a-sct) is the only available curative therapy in children with hla matched sibling which is available to approximately % patients. in the absence of msd, mud transplant with high compatibility criteria has still limited experience. mismatch related, cord blood and haploidentical donor scts are considered experimental. a-sct carries a substantial risk of saes and mortality, both increasing with recipient age and disease severity. dfs is % in paediatric and % in adults. gene therapy for correction of the a-globin chain imbalance overcomes the problems of donor availability and immunologic complications associated with a-sct. multicenter clinical studies on gene addition therapy by using self-inactivating lentiviral vector are currently underway. recently, gene editing by either gene disruption or gene correction emerged as a potential alternative to gene addition therapy in beta-thalassaemia. a new era of novel therapeutics is unfolding in thalassemia management. several targets have been identified that can improve alpha/beta chains imbalance, ineffective erythropoiesis, or iron dysregulation and a number of those now have agents in preclinical and clinical development. hydroxyurea may improve globin chain imbalance and be beneficial for reducing or omitting transfusion requirement in selected group of patients. ruxolitinib has shown the limited effect on pretransfusion haemoglobin and reduction in transfusion needs, but allowed steady decrease in spleen volume that may serve for avoiding splenectomy in beta thalassaemia. luspatercept may restore normal erythroid differentiation and improves anaemia and hepcidin mimetics or tmprss inhibitors may modulates ineffective erythropoiesis by iron restriction and improves anaemia and organ iron loading. background: thalassaemia major (particularly b-type) and sickle cell disease (scd) are the commonest clinically important haemoglobinopathies, representing major sources of morbidity. recommended therapy is regular transfusion of safe, good quality blood, and monitoring of related complications. thalassaemia international federation (tif) guidelines, in place since , include strategies for precautionary measures and use of scientific progress in detection, inactivation and elimination of transfusion transmissible pathogens. antigen-matching strategies to avoid alloimmunization against rbc antigens and other measures including haemovigilance are key components for safe blood, alongside voluntary, non-remunerated blood donation and laboratory quality assurance programmes. aims: we present the contribution of tif and the greek experience in ensuring safety and availability of blood for thalassaemia patients applying internationally accepted standards and recommendations. methods: tif -a non-profit, patient-driven organization with national thalassemia associations in countries -promotes national control programmes for prevention and management contributing to the achievement of final cure. the main working methods are provision of education, expert support, networking, communications and projects to support improvements in the quality of health, social and other care. in greece, technical standards for blood donor selection and testing are applied in compliance with directive / /ec as well as haemovigilance programmes and traceability procedures for recording adverse reactions and events associated with the transfusion of rbcs (directive / /ec). pre-transfusion and transfusion measures recommended by the council of europe are applied. in particular, measures for transfusion of "the right blood at the right time for the right patient", leucodepletion, rbc washing and accurate cross-matching and antigen and antibody screening for an extended matching policy are practised. fresh (up to days old) rbcs are used. molecular testing for abo and rh d is performed in cases with blood group discrepancies. haemovigilance in greece covers % of total blood supply. data on ttis in , patients with thalassaemia and scd-thalassaemia in - are analysed. results: tti prevalence in thalassaemia syndromes was: hbv . % (occult type . %), hcv %, hiv . %, htlv . %, wnv . % and hev %. most frequent adverse reactions in - were allergic (incidence : ), non-haemolytic febrile reactions : , , "other" : , , alloimmunisation : , , taco : , , tad : , , tt-hev : , . hyperhaemolysis was diagnosed in two scd patients, delayed haemolytic transfusion reaction in one thalassaemia intermedia patient. trends in - show reduced incidence of alloimmunisation against rbcs. rates of allergic and pyrexial ars remained stable. no major abo incompatibility case was reported and no fatal transfusion reaction of transfusion has been recorded. summary/conclusions: blood safety in transfusion has significantly improved in high and upper-middle income but unfortunately not in lower and low income countries. blood shortages and lack of stringent protective measures for thalassaemia patients is the reality for many developing countries. tif focuses particular attention on the provision of support and the promotion of initiatives promoting the safety and adequacy of blooda key component of the lifelong management of patients with transfusion-dependent thalassaemia. background: b thalassemia is the most common group of hereditary hemoglobinopathy diseases. affected people with major thalassemia are dependent on regular blood transfusion which leads to iron overload. hepcidin is a peptide and an important regulator of iron homeostasis. expression of this hormone is influenced by polymorphisms within the hepcidin gene, hamp. aims: this study aimed to analyze the association of three polymorphisms in promoter of hamp, rs , rs , and rs with iron overload in major b thalassemia patients who do not respond to iron chelating therapy. materials and methods: a total of samples from major b thalassemia patients were collected. genomic dna was extracted and sequenced for snps rs , rs , and rs . statistical analysis was performed on ibm*spss* statistic using independent t test and fisher test. results: our analysis revealed statistically significantly difference between the level of cardiac iron concentration and c.- a>g variant (p = . ). for rs statistical analysis was on the edge of significant relationship between minor allele and serum ferritin (p = . ). all samples were homozygous for allele t of rs . summary/conclusions: different factors affect iron overload in thalassemia. our findings and others emphasize the role of hepcidin polymorphism as a key component in iron homeostasis. ten to twenty years ago, countries in south eastern africa faced the peak of the devasting hiv/aids epidemic leading to an up to years drop in general life expectancy. with the burden of hiv/aids falling mainly on the economically active population of young and medium-aged adults, the epidemic endangered social and economic stability in nations most heavily affected. today, despite aids still being a major cause of death in south eastern africa, the epidemic has become an example of public health gains that can be achieved through programmatic, evidencebased approaches that are endorsed by globally aligned policy and funding strategies. based on his work from lesotho, where one out of four among adults is infected by hiv, niklaus labhardt will take the auditors through the history of hiv programs in south eastern africa and show how innovative, pragmatic and evidence based implementation brought the region to a stage where the goal to end the aids epidemic by might be in reach. background: in france, the deferral for men who have sex with men (msm) was reduced from permanent to months in july . since this change has not impacted the residual risk (rr) of undetected hiv among blood donations, the ministry of health is considering a greater access of blood donation to msm. two scenarios have been studied: s . deferral of msm during the months preceding the donation; s . deferral of msm who have had more than one sexual partner in the months preceding the donation, similarly to all other blood donors in france. aims: to assess the impact of these two scenarios on the hiv rr estimated over the period july -december which is the baseline rr with the current month deferral for msm. methods: baseline hiv rr was calculated with the classical incidence-window-period method, where hiv incidence was derived from a detuned assay (eia-ri) detecting recent infections (≤ days) since all hiv- antibodies positive blood donations are tested with this test. the assessment of the impact of both scenarios on the baseline hiv rr was based on (i) data obtained from surveys among msm in the general population and in blood donors (compliance survey), to estimate the number of additional msm who would give blood in each scenario, and on (ii) hiv incidence estimate among these additional donors. this incidence was estimated: for s , from msm blood donors with the current deferral policy ( months) and for s , from monogamous msm of the general population. results: from july to december , / ( %) hiv- positive blood donors tested with the eia-ri were identified as recently infected, allowing to estimate the baseline hiv rr at . in million donations [ % ci: . - . ], or in , , donations. for s , the number of additional msm donors was estimated at and the number of additional hiv positive donations at . , resulting in an hiv rr of . in million donations [ % ci: . - . ] or in , , donations. for s , the number of additional msm donors was estimated at , and the number of additional hiv positive donations at . , resulting in an hiv rr of . in million donations [ % ci: . - . ] or in , , donations. sensitivity analysis shows that if both the number of msm and the hiv incidence were multiplied by . , the risk would be in , , donations for s , and in , , for s . summary/conclusions: for both scenarios, the hiv rr remains very low. for s ( -month deferral), the risk is identical to the baseline rr and is very robust to variations in the model parameters. for s (no more than one sexual partner, months), the risk is . higher than the point estimate of the baseline rr and sensitivity analysis shows that this estimate is less robust than for s , since the risk could be times higher than the baseline rr. for both scenarios, there was a modest increase in eligible msm donating. d-s - background: recruiting safe blood donors amongst the largest hiv-positive population in the world is a major challenge for south african blood transfusion services. south african donor deferral criteria and deferral periods for perceived high risk activities have evolved over time, but current risk factors for infection have not been formally assessed. in addition, most studies have reported risk factors for prevalent hiv infection whereas risk behaviours for incident infection are more informative as donations with these infections could occur during the window periods of available screening assays. aims: to identify the demographic and behavioural risk factors associated with incident hiv infection among blood donors in south africa. methods: we conducted a case-control study with incident hiv-infected blood donors compared to infectious marker negative controls. incident hiv cases and controls seronegative for hiv, hepatitis b and c viruses and syphilis were accrued from a donor pool covering of provinces in south africa. controls were frequency matched at a : ratio to cases on race, age and geography. incident hivinfections were hiv rna positive by individual donation nucleic acid amplification testing (id-nat; procleix, grifols) but antibody (ab) negative (prism, abbott) as well as those rna+/ab+ donors with recently-acquired hiv based on limiting antigen avidity (lag) assay results with normalized optical density values of < . . eligible cases and controls completed a confidential audio computer assisted structured interview (acasi) on motivations for blood donation and behavioural factors, including behaviours in the months before donation. frequencies and measures of statistical association for risk behaviours comparing cases and controls are reported after adjusting for multiple comparisons. results: from november to january , we enrolled incident hiv cases and controls; ( . %) cases and ( %) controls were ≤ years old. there were significantly more female cases ( . %) than female controls ( . %) (p < . ). significant hiv risk factors (all p < . ) reported within the -months before donation included: having a primary sex partner who is male; reporting increasing numbers of male sexual partners for both females and males; frequency of vaginal sex; frequency of vaginal sex without condoms; use of methods to clean, dry, or tighten one's anus before sex; and having visited a traditional healer for medical care. lack of medical aid (private health insurance) and reports of injury or accident with blood loss were also associated with an incident hiv infection. summary/conclusions: our study has identified a set of novel, putative risk factors for incident hiv infection among south african blood donors while confirming a number of previously known sexual risk behaviours. not having private health insurance and being injured may be markers of socio-economic context that place individuals at higher risk rather than behaviours that directly increase hiv transmission risk. the detection of risk behaviours by acasi in donors who passed predonation questionnaires and interviews suggests that acasi has the potential to improve risk behaviour identification. background: in france from to , among male blood donors (mbds) found hiv- positive at blood donation screening, % did not disclose any risk factor for hiv infection during post-donation interviews, while % reported having sex with men (msm), and % and % reported heterosexual sex (hts) and other risk factors, respectively. aims: in order to gain new insights into the risk factors for hiv- infection in mbds, we performed an hiv- genetic network analysis, including hiv- positive mbds and patients included in the french primary hiv infection anrs co primo cohort (pc). methods: mbds, who donated blood between and , and pcs, included between and , were studied. epidemiological data were collected by the french blood service (efs) upon blood donation or post-donation interviews for mbds, and upon inclusion for cps. viral strains were sequenced and genotyped in pol gene, and a recent infection assay was performed to date infection in mbds (recent: < months). a partial transmission network was computed based on tamura-nei nucleotidic distance (threshold for hiv- s/t b = . %; for non-b s/ t = . %) and assortative mixing was evaluated for mbds epidemiological data, including risk factors for hiv infection (msm, hts, others and unknown). selfreported data were then compared to assortativity-enhanced data. results: hiv- strains from mbds and pcs were linked into clusters including at least one mbd. primo-only clusters were excluded from the analysis. compared to mbds who did not cluster, those found linked to the network were younger ( vs. year-old; p < . ) and were more likely to have a recent infection ( % vs. %; p = . ). assortative mixing indexes showed that paired individuals were more likely to live in the same area (p < . ) and to have the same risk factor for hiv infection (p < . ) compared to a random distribution. imputing msm risk factor to non-msm individuals paired with msm changed the distribution of risk factors as follows: msm: % vs. %, hts: % vs. %, other: % vs. % and unknown: vs. %. summary/conclusions: after validating the assortativity of risk factors between paired individuals, and imputing msm risk factor to individuals self-reported as non-msm (including those with no identified risk factor), up to % ( / ) of mbds could be reclassified as msm. this is a worst-case scenario, as the network analysis does not exclude the possibility of one or several persons between two paired individuals (missing link). altogether, these results could help reevaluate the hiv residual risk linked to msm mbds, especially in the frame of the evolution of blood donor deferral criteria. background: although most individuals remain asymptomatic, htlv infection can lead to adult t-cell leukaemia/lymphoma (atll) and htlv- associated myelopathy (ham). the serious nature of these diseases, evidence of transmission via non-leucodepleted blood, and concern about a high prevalence among donors originating from endemic areas led to the uk blood services introducing universal blood donation screening in . monitoring through routine surveillance commenced and htlvinfected donors were invited to participate in the htlv national register cohort study to assess disease progression. these data together with evidence from lookback to previously untested donations and cost-effectiveness analysis were reviewed by an expert working group in and . aims: to describe the epidemiology of htlv among uk blood donors and evidence of disease progression from long term follow up of asymptomatic donors. methods: uk blood donations screened, and infected donors identified are reported to a national surveillance scheme. these donors are contacted, their results explained and information about clinical history and possible sources of infection are collected. where appropriate, htlv-infected donors are consented to the register, with participants completing a baseline questionnaire about their health, flagged in registries for cancer or death, and followed up about every - years. results: in the uk - , htlv-infected donors were identified. prevalence among new donors was steady around / donations. prevalence among repeat donors peaked in ( . / donations), with most in previously untested. from to , prevalence of . per , donations (average of one positive/year) was recorded. in , prevalence among new donors increased to . / , donations ( positives), with increased numbers associated with asian ethnicity and coinciding with an increase in collections from bame groups. overall, most were women ( / , %), uk-born ( / ; %) and htlv- infections ( / ; %). mean age was years. almost all positive donations were from previously untested donors ( / ), with seroconversion within a year of previous donation confirmed for only of the previously tested donors. typically, infections were associated with endemic countries (including caribbean region, west africa, iran, india and japan), acquired through breast feeding or from their heterosexual partner originating from these countries. interestingly, three were thought to have been infected through self-flagellation. a total of htlv-positive asymptomatic blood donors have already been recruited to the htlv national register, and during over -person years follow-up, none had developed atll or ham. summary/conclusions: over years of testing, few seroconverters were identified, suggesting very little ongoing transmission among uk blood donors. the lack of disease among the cohort study was also reassuring, although it is likely too early to detect associated symptoms of a slow progressing disease. recruitment to this unique dataset continues, also outside of the blood donation setting. as a result of these surveillance data, evidence from lookback, and cost-effective analysis, in nhsbt ceased to test donations from previously tested donors unless the donation was being used to manufacture a non-leucodepleted component. finland lies in northern europe between the °and °n latitude. the length of the country is km and width km. by surface area it is the fifth largest country in eu. the population of the country is . million resulting in the lowest population density in eu ( . inhabitants/km ). the whole country is inhabited, although most of the population is packed in the south. the climate of finland is influenced mainly by its latitude, but the warm waters of the gulf stream and the north atlantic drift current also play a role. due to finland's northern location, winter is the longest season. the southern portions of the country are snow-covered about three or four months of the year, and the northern regions for about seven months. long distances, low population density and the extreme climate give logistical challenges. it is estimated that these logistical costs can be as much as - % of gdp in finland. the finnish red cross blood service (frc bs) has been the nationwide blood service provider in finland since . frc bs collects annually about whole blood units of which % are collected in fixed sites and % in mobile sessions around the country. central activities (donor recruitment, medical support, production, testing, supply chain management, digital services and administration) are located in helsinki. management of transfusion is highly dependent on the logistical arrangements from blood donation sites to the central facilities and from the central inventory to the hospitals. the logistics is outsourced to three major partners all of whom have their roots in nationwide public transportation and logistics services. posti ltd is a state owned company having its roots in the national postal and telecom office. today it is the leading postal and logistics service company having the widest network coverage in finland. blood units collected at different fixed sites and mobile sessions are transported overnight by posti ltd to the frc bs central facilities by am on the day following the blood donation. posti ltd is also used for the regular deliveries of blood products to the hospitals. the other important partner is matkahuolto ltd, which was founded in the s to maintain bus stations and to serve as a common marketing company for the bus and coach services in finland. it maintains a nation-wide package delivery system based on the scheduled bus route network. matkahuolto ltd is used to transport donor testing samples from the donation sites to the central laboratory. by this arrangement it is possible to obtain most of the donor samples to the laboratory around midnight, which significantly speeds up the completion of laboratory results. the third logistics partner is jetpak finland ltd, which operates the air freight for the national flight company finnair. blood transfusion services can be managed centrally in a large sparsely populated country in a manner that is of high quality, safe and cost effective. however, the supply chain has to be planned carefully. background: elearning is a divisive topic. it is often criticised as an inferior form of education while simultaneously being promoted as a means to provide education to large numbers of people in a consistent, cost-effective manner. bloodsafe elearning australia (bea) is a government-funded blood transfusion education program that commenced in and provides courses in clinical transfusion practice and patient blood management (pbm) including: -clinical transfusion practice ( courses) -pbm: general ( courses) -pbm: medical ( courses) -pbm: acute care and surgical ( courses) -pbm: obstetrics and maternity ( courses) -pbm: neonates and paediatrics ( courses) aims: to determine the engagement, outcomes and impact of learning of bloodsafe elearning australia courses. methods: a retrospective analysis of user registrations, course completion records, course evaluation data and red cell usage in australia to determine learner demographics, and the impact on acquisition of knowledge and application to clinical practice. results: in the period from july to january : - , people registered as learners - , , courses were completed -these learners came from countries, with , ( . %) of them from outside of australia. analysis by profession shows that: - . % are nurses and/or midwives - . % are medical - . % are laboratory, anaesthetic technicians or other. analysis of user evaluation data (n = , ) from april to january shows that these courses have a positive impact, with . % of respondents stating they gained additional knowledge, . % able to make changes to clinical practice, and . % reporting that these changes will improve patient safety and outcomes. analysis of international participants shows greater benefits with . % gaining knowledge, . % able to change their clinical practice and . % believing this will improve patient outcomes. analysis of red cell usage in australia shows that since there has been a . % reduction in red cells issued. this has been achieved through a number of pbm activities including development of guidelines, research and audits, education, waste reduction strategies, and promotional campaigns. bloodsafe elearning australia courses on pbm were released in and are one part of this pbm activity, and it is notable that these courses have the widest reach as they are undertaken by a large proportion of doctors, nurses and midwives in australia who are not directly involved with the blood sector. stakeholder feedback shows that the program provides credible, consistent education that is cost-effective, reduces duplication, is 'best-practice' elearning, is readily accessible, and allows institutions to focus on the development of practical transfusion skills. summary/conclusions: this analysis shows that elearning is a well-accepted, wellutilised form of education for healthcare workers to learn about clinical transfusion practice and patient blood management, and learners gain knowledge that can change their clinical practice and improve patient outcomes. it is also likely that these courses have contributed to better utilisation of a scarce, freely-donated resource. this approach has global reach and availability, and is a cost-effective model for improving transfusion practice in the developing world by providing education for millions of healthcare workers. d-s - prospective platelet auditing: analysis of trainee compliance with guidelines pathology, columbia university, new york, united states background: apheresis platelets are a component product with high cost and limited supply. furthermore, there is a potential for severe transfusion reactions associated with this product such as transfusion related lung injury (trali), and sepsis due to bacterial contamination. therefore, transfusion guideline compliance is closely monitored by many centers. this quality assurance analysis describes our experience with prospective platelet auditing performed by physicians in pathology residency training. aims: this study aims to evaluate the ability of physicians in training to perform prospective auditing and compare policy compliance for different levels of experience. methods: this is a quality assurance analysis of a prospective platelet audit program for a -month period (january -december ). the blood bank paged the on call physician any time an order was placed for a patient with a platelet count of > , /ll, ≥ doses of platelets with no interim repeat count, or an unknown platelet count. audit records created by physician trainees in their first post graduate year (pgy ) were compared to subsequent years (pgy > ). information collected included the total number of doses requiring approval, number of products approved, training year for the approving physician, and transfusion indication. cost analyses assumed $ for a dose of platelets. descriptive statistics and comparative analysis using a pearson's chi-square were used with a difference of p < . considered statistically significant. results: there were platelet doses requiring approval with ( %) routed to the pgy group and ( %) to the pgy > group. there were ( %) ordered doses that were in compliance with hospital transfusion policy and ( %) that were not in compliance with hospital policy. of the appropriately ordered doses, the pgy group declined release of necessitating the clinical team to insist upon release without approval, and there were zero such instances in the pgy > group. when paged by the blood bank, pgy physicians approved product release not in compliance with policy for / ( %) doses while pgy > physicians approved not indicated products for / ( %) of doses (p < . ). products not indicated by hospital policy were held from release by pgy physicians for / ( %) doses and / ( %) doses by pgy > physicians (p < . ). the ordered doses not in compliance with hospital policy had an estimated cost of $ , . of this cost, there was a calculated $ , savings of products not released due to prospective auditing. there was an additional potential savings of $ , for products not indicated but released ($ , from the pgy and $ , from the pgy > group). summary/conclusions: despite a higher number of requests being routed to the more senior pgy > group, there were a disproportionately higher number of out of compliance platelet orders being released by the pgy group in addition to withholding needed products on several occasions. potential mitigation strategies for this could include a closer level of oversight for pgy physicians, and the potential monetary savings could justify a hiring a dedicated patient blood management team or quality assurance manager to monitor compliance and provide feedback to clinicians. d-s - what can we learn from how adverse events are detected? norwegian directorate of health, oslo, norway background: the primary aim of reporting systems, such as haemovigilance systems, should be learning and improvement and to identify risk areas, not simply counting errors. to understand and learn from adverse events the description of how, where and why they occur, and how they are detected, is important. to support our understanding, we use a predetermined classification that is required for reporting to eu, supplemented by classification suggested by ihn, who and ourselves. in we started asking the blood establishments what steps they would take to prevent recurrence of the event, and we added a simple classification to tell how the adverse event had been detected. aims: this study aims to analyze how different types of adverse events reported to the haemovigilance system were detected, whether the current quality management systems used in norwegian blood establishments had effective barriers and whether new barriers should be considered. methods: adverse events reported to the norwegian haemovigilance system in and were analyzed with focus on how the adverse event had been detected. in all cases classification had been performed by the reporter of adverse events and were confirmed, or reclassified if necessary, by the haemovigilance team before analysis. for analysis based on classification we used powerbi (microsoft). results: a total of adverse events were reported from norwegian blood establishments. all had been classified according to how the adverse event had been detected. twenty ( . %) adverse events were detected because of alarms or warnings from it-systems or equipment. routine checks by blood establishment staff detected ( . %) events and formal internal or external reviews detected one event. seven ( . %) events were detected because the donor became ill shortly after donation, but the illness was not caused by the donation. sixty-four percent of events were detected in a way that did not fit our present classification and hence were classified as "other". twelve out of wrong blood in tube were detected by an alarm from the it-system or routine check, as were six of events related to blood ordering, two of seven errors in testing, six of events where incorrect blood had been transfused, and eight of events related to donor selection. in reports human error was listed as the cause of the event and of these were detected by alarms or routine checks. summary/conclusions: detection of adverse events by alarms or routine checks are highly efficient when the blood establishment has historic data to check against, as exemplified with wrong blood in tube or a patient require irradiated blood components. when no historical data exists or when the quality management systems do not require routine checks, events are usually detected by chance. further analysis is needed to see if and where the quality management systems should be improved. the wide variety of adverse events can make it difficult to select which area to prioritize in the improvement work. results: the hb measurements from the finger prick were on average . g/l ( . %) higher than from the venous blood samples. the range of the difference was - -+ g/l. these results were used in order to add novel information to determine the measuring uncertainty of hb measurement in frcbs. in . % ( / ) of the donors in this study the venous hemoglobin measurements were below the cut-off point of donor eligibility. in those measurements the difference of the finger prick and venous hemoglobin measurement was at most + g/l. % of the hemoglobin results from the finger prick were in the range ae g/l compared to the venous hemoglobin results. % of the results from the finger prick were between ae g/l (the precision of the device) compared to venous hemoglobin results. in cases the difference between finger prick and venous measurements was outside standard deviations from the mean i.e. . % from the bottom (n = ) or top (n = ) of distribution. systematic errors were seen in some nurse's results both towards too low or too high hb result in the finger prick measurement and some nurses had random errors in both directions. the batch of cuvettes, donors' age, gender or the time of sampling were not detected to have an impact on the difference between finger prick and venous hb measurements in this study. summary/conclusions: the results of the poc measurements compared to the cell counter were in agreement with published data and with manufacturers' information on the device. the practical skill test is a workable way to develop competence and operations to measure the hemoglobin from the finger prick. it offers an opportunity to give personal feedback to nurses concerning their personal performance in the use of the current hb measurement technic. it also provided data on the accuracy of the poc method in the everyday donor selection process. background: whole blood donation has frequently been related to iron deficiency. a blood donor loses per donation about % (men) to % (menstruating women) of iron stores. to replenish the iron lost by blood donation in a donation interval of days, a donor needs to absorb . mg iron per day. this amount exceeds the reported maximal amount of absorbed iron of - mg/day, eventually leading to iron deficiency, with consequences such as donor deferral and possibly iron deficiency-related symptoms (decreased physical endurance, fatigue, pica, restless legs syndrome, and cognitive functions). since hb levels do not reflect donors' true iron status, measuring ferritin is a better way to detect low iron stores in whole blood donors. studies from usa and denmark showed that on the introduction of ferritin measurement with either extension of donation intervals or iron supplementation in case of low iron stores, deferral percentages for low hb declined in both male and female donors. aims: to gain more insight in iron status of whole blood donors during their donor career, how this affects donor health and which measures may prevent low iron stores in donors. methods: in the netherlands, sanquin blood bank is currently implementing a policy with ferritin-guided donation intervals. in brief, ferritin levels are measured in all new donors and in repeat donors every th donation or in case of an hb below the deferral threshold. donation intervals are extended if ferritin levels are < lg/ l, or ≥ and ≤ lg/l (for and months respectively). we anticipate that routine ferritin measurement will ultimately result in a lower prevalence of iron deficiency, less hb deferrals and improved donor retention. this will be further evaluated in a stepped wedge cluster-randomized trial 'find'em', which may also identify subgroups of donors prone to develop (symptoms of) iron deficiency. in addition, implementing ferritin screening may lead to a decreased donor availability. for this purpose, we modeled the impact of the implementation of our ferritin deferral policy on donor availability over time, which provides insight for both the expected size of the impact of the ferritin deferral policy and the time and rate at which this impact is expected to occur. this allows the blood bank to timely plan actions to counterbalance possible donor shortage and ensure an adequate blood supply. lastly, iron supplementation can be an alternative measure instead of donation deferral. as the used and recommended dosage of iron supplementation varies widely across blood services, sanquin is planning to start a new study in whole blood donors to gain evidence on the dosage and frequency of iron supplementation and its effect on ferritin and hemoglobin levels and donor health. results: the before-mentioned studies are ongoing and results will be expected from onwards. summary/conclusions: iron deficiency is a frequent side effect of whole blood donation. to prevent iron deficiency and its consequences, like donation deferral and health issues, more evidence-based insight in iron management of whole blood donors is being generated. d-s - superdonors -genetic risk profile and risk of low hemoglobin deferral background: no reliable method exists for stratifying new blood donors into those who can maintain sufficient hemoglobin (hb) levels and those who will be deferred because of a low hb (< . mmol/l [< . g/dl] for women and < . mmol/l [< . g/dl] for men). polygenic risk scores (prss) have shown great promise in predicting complex disease risk. prss could also prove useful for identification of donors genetically predisposed to low hb levels, and, thus, to an increased risk of deferral. aims: the objective of the study was to evaluate the association between prs (modelled to predict hb level as a quantitative trait) and risk of deferral as a binary outcome. methods: the danish blood donor study (dbds) is an ongoing nationwide blood donor cohort since with more than , participants. extensive genotyping has been performed on approximately , dbds participants using the infinium global screening array (illumina â ) and extended by use of imputing based on the pan-scandinavian reference genome. based on hb and genetic data on more than , icelandic individuals (an independent discovery cohort), we constructed different weighted prss for individuals from dbds. information on the donors' whole blood donations following inclusion into dbds unto end of was obtained from a nationwide donation database, scandat. the best predictor of hb among the nine prss was chosen and used in all subsequent analyses. we performed multilevel mixed-effects linear regression analysis with hb as outcome, and prs as factorized explanatory variable with cutoffs at , , , , , , , and th percentiles, respectively. moreover, the models had a two-level clustering on donor id and donation site and an id-specific random intercept; and further adjusted for: sex(binary), age(continuous), year of donation(factorized), and time since last donation (continuous). lastly, risk of deferral was evaluated in random effects logit models with similar covariables and clustering structure. results: mean number of donations per donor after dbds inclusion was . donations. generally, we observed a statistically significant positive association between prs(hb) and current hb levels. compared with donors in the - prs percentile group, donors below the th percentile had lower (- . hb mmol/l ( % ci: - . ; - . )) and donors above the th percentile higher (+ . hb mmol/l ( % ci: . ; . ) hb levels. in the random effects logit models we observed a marked increase in deferral risk with decreasing prs percentile strata. with the - prs percentile stratum as reference, donors below the th percentile and donors above the th percentile had odds ratios of deferral of or = . ( % ci: . ; . ) and or = . ( % ci: . ; . ), respectively. summary/conclusions: we found a statistically significant positive association between prs(hb) and hb levels and a markedly increased risk of deferral with decreasing prs(hb). from a scientific point of view, it is unsurprising that a genetic score for hb from an independent cohort is associated with hb in another cohort. however, from a practical perspective, prss may be the first step in a personalized donation approach to donors and their risk of deferral. background: individually calibrated inter-donation intervals for repeat blood donors have the potential to minimize the risk of iron related adverse outcomes (e.g., hemoglobin deferral or collecting a donation from a donor with low or absent iron stores) without unduly impacting the donated blood supply. machine learning has shown promise for personalized clinical risk assessment. aims: our aim is to use machine learning to develop donor-specific, personalized inter-donation intervals that minimize the risk of adverse outcomes while maintaining or improving the adequacy of the donated blood supply. methods: using a public use dataset from the reds-ii donor iron status evaluation (rise) study (cable, transfusion, ) we defined donor profiles with physiological measures including hemoglobin, ferritin and soluble transferrin receptor along with questionnaire responses regarding diet, reproductive health indicators, and demographics. we used these profiles ( features, , donations from , repeat donors) and the time until the next donation attempt to predict iron-related outcomes of the next donation attempt. possible outcomes were no adverse outcome, hemoglobin deferral, low-iron donation (ferritin < ng/ml for women and < ng/ml for men), or absent-iron donation (ferritin < ng/ml for men and women). we trained multiple machine learning models on , of the donations and selected the model with the best performance (lowest cross-entropy loss in cross validation). we assessed the best model's performance on a hold-out test set of donations, which were not used to train or select the model. we then used our model to generate risk estimates for these test donors as a function of days since their last donation, which varied from days to days. to show individual variation, we generated graphical representations of individual donors' risk over time. results: ferritin, log ferritin, body iron, and time since last donation were most useful for predicting iron-related adverse outcomes at the next donation attempt. the estimated risk of adverse outcomes at the next donation attempt varied considerably across donors. as expected, the risk of adverse outcomes days after the last donation was lower than the risk days after the last donation for most donors (risk of hemoglobin deferral decreased for % of donors; risk for low-iron donation decreased for %; and risk for absent-iron donation decreased for %). summary/conclusions: the risk of iron-related adverse outcomes as a function of time since last donation varies considerably between donors. machine learning models trained on relevant donor profiles can effectively estimate how an individual's risk will change over time. individual risk estimates could allow blood centers to protect highrisk repeat donors while continuing to allow more frequent collections from low-risk donors. further study is needed to ensure this approach works well for donor classes that are not well-represented by the rise dataset, to assess risk prediction outside of the physiological measures collected in the rise study, and to determine the viability of assigning an optimal inter-donation interval to a first-time donor using this approach. background: iron depletion is common among repeat blood donors, who contribute a large proportion of the blood supply in many countries. exogenous iron from multivitamins with iron or iron-only supplements helps prevent donation-induced iron depletion, but whether dietary iron protects against iron depletion in repeat donors has not been rigorously evaluated. available data from the reds-ii rise study in the us (cable, transfusion, ) and from the danish blood donor study (rigas, transfusion, ) suggest minor impact of dietary iron consumption on blood donor iron status in multivariable regression models. both studies, however, analyzed food items singly, such as beef or fish, rather than in aggregate, so precision was limited. aims: to evaluate whether a composite measure of dietary heme iron consumption, weighted for frequency and iron content, was associated with incident iron depletion among repeat blood donors. methods: a re-analysis of the rise cohort was undertaken to test the hypothesis that reported levels of animal protein consumption was associated with lower risk for incident iron depletion among repeat blood donors. the six blood centers participating in rise enrolled first-time and frequent donors for - month follow-up of donation frequency and iron status. a brief checklist of food categories was administered at baseline to assess frequency of consumption of several categories of animal protein that are rich in heme iron, the biochemical form of iron most readily absorbed. an iron composite score (ics) weighted for frequency and heme iron content was derived and subjects were grouped into tertiles (thirds) of ics. iron status was assayed at enrollment and study completion and at roughly one-third of donation visits in between. modified poisson regression with generalized estimating equations was used to generate risk ratios controlling for donation frequency and other covariates. results: of enrolled donors, were iron replete at baseline and completed the food checklist. the median value of the ics for each tertile (lowest to highest) was . , . , and . mg of heme iron weekly. these values are equivalent to approximately , , and servings of beef per week, or alternately twice as many servings of chicken or pork. across follow-up visits with iron outcomes assayed, almost % of donor visits were associated with intermediate iron depletion (serum ferritin < ng/ml) and . % with complete depletion of iron stores, representing serum ferritin < ng/ml. after controlling for demographic factors and donation frequency, the lowest tertile of ics was associated with a greater than fold higher risk for complete iron depletion during all follow-up visits (rr . , % ci . , . , compared to the highest tertile). summary/conclusions: in this longitudinal evaluation of dietary iron and iron status, blood donors with low intake of heme iron had an elevated risk for developing advanced iron depletion. these results suggest that blood centers should continue to recommend iron-rich diets to repeat blood donors. background: blood donors lose approximately mg of iron with every blood donation. as a result, frequent blood donors are at risk of iron deficiency and low hemoglobin (hb) levels, which may affect their health and eligibility to donate. lifestyle behaviors such as dietary iron intake and physical activity, may influence iron stores and thereby hb levels. gaining insight into associations between lifestyle behaviors and hb levels is valuable for blood supply organizations, as lifestyle behaviors can potentially be considered to prevent hb deferrals. examining the mediating role of ferritin, a measure reflecting iron stores, in these associations will help to gain insight into whether iron stores could be the limiting or enabling factor that links lifestyle behaviors to hb recovery after donation. aims: to investigate associations between lifestyle behaviors (dietary heme and non-heme iron intake and physical activity) and hb levels, and whether ferritin mediates these associations. methods: donor insight-iii (dis-iii) is a dutch cohort study of blood and plasma donors and included , donors. participants who were pregnant, had hemochromatosis, used iron supplements/medication, got a hysterectomy or bilateral oophorectomy were excluded (n = ). hb levels were measured in edta whole blood samples using a hematology analyzer (xt- , sysmex, japan) and ferritin was measured in plasma from lithium heparin tubes (architect ci , abbott laboratories, u.s.a.). dietary heme and non-heme iron intake (grams/day) were assessed using a food frequency questionnaire adapted to measure iron intake. moderate-tovigorous physical activity (mvpa, minutes/day) was assessed using the international physical activity questionnaire (ipaq)-short form. results: in total, , ( , female) participants were included. donors with higher intakes of heme iron had significantly higher hb levels (regression coefficient (b) ( % confidence interval ( % ci)) in men and women respectively: . ( . to . ) and . ( . to . ) mmol/l), independent of age, smoking, menstruation, number of donations in previous two years, donation interval, sedentary behavior, the other lifestyle variable (i.e. (non-)heme iron intake or mvpa), and initial hb level. non-heme iron intake was negatively associated with hb levels (- . (- . to - . ) and - . (- . to - . ) mmol/l for men and women respectively). ferritin mediated associations between dietary iron intake and hb levels (indirect effect in men and women respectively: . ( . to . ) and . ( . to . ) lg/l for heme and - . (- . to . ) and - . (- . to - . ) for non-heme). more mvpa was negatively associated with hb levels in men only (- . (- . to - . )), which was not mediated by ferritin. summary/conclusions: in conclusion, higher heme and lower non-heme iron consumption are associated with higher hb levels in donors via higher ferritin levels, indicating that donors with high heme iron consumption may be more capable of maintaining iron stores to recover hb levels after blood donation. more mvpa was associated with lower hb levels, although effect sizes were small, independent of ferritin. taking a donor's lifestyle behaviors into account may be useful in preventing low hb levels in blood donors. immune thrombocytopenia (itp) is still diagnosed by exclusion of other causes for thrombocytopenia. sensitive and specific detection of platelet autoantibodies may support the clinical diagnosis and prevent misdiagnosis of itp. for example, the direct monoclonal antibody immobilization of platelet antigens (maipa) assay, performed with in vivo sensitized patient platelets, offers platelet glycoprotein specific autoantibody detection with high accuracy. a drawback is that low platelet counts demand a large blood sample to have sufficient patient platelets available for analysis. circulating platelet autoantibodies are more difficult to detect by maipa; and may demand more sensitive detection platforms, such as those using surface plasmon resonance. in general, the presence of anti-gpiib/iiia, anti-gpib/ix and anti-gpv platelet autoantibodies is investigated. all these antibody specificities have been found in patients with itp. in itp, platelet autoantibody-mediated destruction via the spleen has been proposed; but also other mechanisms leading to low platelet counts in itp may play a role. inhibition of megakaryocytopoiesis by autoantibodies or by t cells has been suggested. in mice, gpib-directed antibodies induce loss of platelet-sugar epitopes, inducing hepatocyte-medicated platelet destruction. platelet autoantibodies can cause complement activation, which may contribute to platelet autoantibodymediated destruction. interestingly, we recently found that lack of detectable platelet autoantibodies is correlated with non-responsiveness to rituximab (cd moab) treatment in itp patients. in children with newly diagnosed and often transient itp, platelet autoantibodies of igg class or not often found, but of igm class are present for short duration. in conclusion, testing for platelet autoantibody characteristics and their pathologic effect may be helpful in establishing the diagnosis of itp and in choosing the best individualized therapy for itp patients. a-s - thrombopoietin receptor agonist (tpo-ra) treatment raises platelet counts and induces immunomodulation in immune thrombocytopenia (itp) jw semple , r aslam , e speck , j rebetz and r kapur lund university, lund, sweden st. michael's hospital, toronto, canada background: itp is an autoimmune bleeding disorder in which autoantibodies and/ or autoreactive t cells target the destruction of platelets and megakaryocytes in the spleen and bone marrow. several therapeutic options e.g. corticosteroids, intravenous immunoglobulins (ivig), rituximab and splenectomy are available for patients but inadequate efficacy, side effects and/or expense can make them undesirable. for the last years, tpo-ra e.g. romiplostim and eltrombopag have made a substantial contribution to the treatment of itp patient's refractory to first-line treatments. of interest, approximately % of patients that are tapered from tpo-ra therapy show a sustained response (e.g. a stable higher platelet count than before treatment). the mechanism of how tpo-ra induce these sustained responses is unknown. aims: to analyze the efficacy and immunomodulatory properties of a murine tpo-ra (amp , amgen) in a well-established murine model of itp that demonstrates both antibody-and t cell-mediated thrombocytopenia (chow l et al., blood ) . methods: platelet glycoprotein (gp) iiia (cd ) knockout (ko) mice were immunized with cd + platelets and itp was initiated by the transfer of their splenocytes into mice with severe combined immunodeficiency (scid). the scid mice were treated with either placebo or tpo-ra weekly and platelet counts and serum anti-platelet antibodies were measured weekly. results: in an initial pilot dose escalation study, control na€ ıve scid mice treated with a single subcutaneous bolus of different concentrations of murine tpo-ra ( , and ug/kg) had significantly higher platelet counts by h post infusion. in addition, compared with untreated mice, bone marrow histology revealed significantly increased numbers of megakaryocytes. maximal platelet count increases were observed with the highest tpo-ra dose and this dose was chosen to treat scid mice suffering from itp. when scid mice were treated with weekly injections of tpo-ra, platelet counts began to increase after weeks and were fully rescued to control levels after weeks post splenocyte transfer. of interest, compared with non-treated itp mice, serum igg anti-platelet antibody production in the tpo-treated mice was significantly reduced starting from two weeks post splenocyte infusion. summary/conclusions: these results suggest that murine tpo-ra is not only an efficacious therapy for murine itp but also induces immunomodulation indicative of immunosuppression. thus, this model may be able to elucidate the mechanism of how tpo-ra's induced immunosuppression in patients with itp. background: desialylation, the loss of sialic acid content on platelets (plts) glycoproteins (gps) was recently identified to contribute in immune thrombocytopenia (itp). however, the potential impact of autoantibodies (aabs) on megakaryocyte sialylation remains unclear. aims: to investigate the effect of itp aabs on plts and megakaryocytes (mks) sialylation and the subsequent impact on plt survival. methods: aabs from well-characterised itp patients induced gp-modifications were tested using a lectin binding assay. after incubation of mks or plts with itp or control sera, glycan changes were analysed by flow cytometry (fc). to investigate the impact of desialylation on plts life-span, the nod/scid mouse model was used. results: itp sera were investigated in this study. ( %) sera induced a significant increase in rca signal on plt surface compared to control sera from healthy donors (rca-mean fold increase (rca-fi): . , range: . - . , p = . ). in addition, ( %) sera caused higher ecl binding to test plts (ecl-fi: . , range: . - . , p = . ). injection of desialylating aabs resulted in accelerated clearance of human plts from the circulation of the nod/scid mice which was significantly reduced by a specific neuraminidase inhibitor that prevents background: autoimmune hemolytic anemia (aiha) is a rare autoimmune disease characterised by hemolysis associated with the presence of immunoglobulins (igg, igm, or iga) and/or components of complement system on red blood cells (rbcs), which is usually demonstrated by a positive direct antiglobulin test (dat). depending on the presence of an underlying disorder, aiha can be subdivided into primary and secondary and, by the temperature at which autoantibodies bind optimally to rbcs, into warm antibody aiha (waiha), mixed aiha (including both warm igg and cold igm antibodies), cold agglutinin disease (cad), paroxysmal cold hemoglobinuria (pch) and dat negative aiha. a frequent finding in immunohematology is the presence autoantibodies on rbcs without clinical symptoms of hemolysis that may later develop. aims: the aim of this study was to analyse serologic findings and transfusion support in patients with aiha and also to analyse dat positive patients without clinical symptoms. methods: we included data for all adult patients with aiha and dat positive patients without clinical symptoms diagnosed and/or treated at the university hospital centre (uhc) zagreb, croatia in the period between and . the diagnosis of aiha was defined by anemia with features of hemolysis (elevated bilirubin and/ or elevated lactate dehydrogenase and/or low haptoglobin level) and a positive dat. results: the data from patients ( % women) meeting the inclusion criteria was analysed. the mean age at the time of aiha was years (range - years). the mean hg level at diagnosis was . g/l. dat results were positive mostly with igg+c d ( %) or igg ( %). most patients had warm aiha ( %). other types of aiha diagnosed were mixed aiha ( %), cad ( %), pch ( . %) and dat negative aiha ( . %). in cases alloantibodies were detected with autoantibodies in the patient's plasma. patients were treated with corticosteroids as st line therapy and some with intravenous immunoglobulins (ivig). in severe or refractory patients rituximab and/or splenectomy was applied. a total of % of patients were transfused at a mean hemoglobin level of . g/l. during this period we detected dat positive patients without clinical symptoms. summary/conclusions: most patients from our study were diagnosed with warm type of aiha, followed by mixed type aiha and cad. on the other hand, pch and dat negative aiha were very rare, which is in concordance with relevant literature. most patients were transfused despite therapy used, which is not desirable in patients with aiha and should be better controlled, especially in moderate cases of anemias, where this is rarely necessary. a significant number of patients that were dat positive without clinical symptoms may later develop aiha and should be closely monitored. background: autoimmune haemolytic anaemia (aiha) is a decompensated acquired haemolysis caused by the host's immune system acting against its own red cell antigens. aiha is a rare disorder and although british society of haematology (bsh) guidelines for diagnosis and treatment were published in february , there is little evidence for clinical practice in the united kingdom. aims: to investigate the approach to diagnosis, investigation and management of patients with aiha in english nhs trusts. methods: a survey of diagnostic and management practice was designed, piloted and disseminated to clinical transfusion leads in all english acute nhs trusts from november to march . completion was by a consultant haematologist treating patients with aiha but a response that represented a departmental consensus was encouraged. results: responses represented % ( / ) of english acute trusts. median number of adults with aiha diagnosed annually was - . in the preceding years, % ( / ) recalled at least one patient who had died due to aiha. although % ( / ) undertook a bone marrow biopsy in all patients, % required additional features, mainly: neoplasia, age over or being treatment-refractory. for patients with suspected drug-induced immune haemolysis, % ( / ) would not organise confirmatory tests, either because it was considered unnecessary ( / ), or because clinicians were unsure how to access tests ( / ). when determining aiha subtype, % ( / ) indicated there were no circumstances in which they would undertake cold antibody testing (antibody titre and/or thermal amplitude), with considering this unnecessary and unsure how to access tests. in clinical scenarios of patients with aiha and dat positive to c d ae igg ae cold associated symptoms, up to % ( / ) of respondents would not test for cold antibodies. for first line treatment of primary warm aiha, mean duration of prednisolone mg/kg given before judging the patient refractory and reducing the dose was . weeks (sd . , range - weeks). second line treatment of choice was rituximab for % ( / ) of respondents and splenectomy for %. intravenous immunoglobulin and splenectomy were the most cited rescue therapies. for primary cold haemagglutinin disease (chad), first line treatment was rituximab-based for % ( / ) but single agent steroid for %. we also explored the potential for future audit and research. % ( / ) of respondents were able to identify patients with aiha who previously required transfusion. % ( / ) of respondents would consider supporting a registry of patients with aiha requiring transfusion. the key questions that respondents thought a registry should address were: morbidity and mortality, treatment response, and differences in the diagnosis and treatment of aiha subtypes. there was uncertainty over access to cold and drug-induced antibody tests and clinicians do not always conduct bshrecommended cold antibody tests for aiha with c d positive dat. initial treatment of primary warm aiha and chad broadly matched bsh guidelines although % ( / ) would continue prednisolone at mg/kg beyond the recommended days before starting a taper, with greater toxicity risk. summary/conclusions: the findings support the need for a range of research initiatives, including creation of an aiha registry. preoperative anemia is common and is associated with adverse outcomes in the peri-operative period. preoperative anemia also increases the risk of allogeneic blood transfusions, which may lead to increased perioperative mortality, increased hospital length of stay and infections. diagnosis and treatment of anemia is one of the tenets of patient blood management (pbm), along with reduction in unnecessary transfusions and diagnostic phlebotomy, as well as use of hemostatic agents to reduce bleeding among many others. effective pbm is multi-disciplinary, multi-modal, timely, individualized and patient-centered. early referral to pbm and multi-modal pbm interventions are associated with greater improvement in pre-operative hemoglobin. pbm has been shown to reduce transfusions and cost, while system-wide, multi-modal programs may also be associated with improvement in mortality. using examples from our local research and practice, i will discuss three aspects of pbm. iron and erythropoiesis stimulating agents (esa) are effective, safe and used extensively in management of pre-operative anemia. previous studies have questioned whether esa leads to increased risk of thrombosis, however, recent systematic reviews do not support these concerns. another pbm approach is to reduce bleeding during surgery by using hemostatic agents such as tranexamic acid (txa). txa reduces transfusion requirements in knee and hip arthroplasty, and is safe, widely available and relatively cheap. txa is effective in both anemic and non-anemic patients, making it an attractive universal pbm strategy. finally, recommendations and evidence-based guidelines on pbm exist, including the most recent international guidelines developed by the pbm international consensus conference. however, knowledge translation in pbm has been a problem and a number of barriers to its implementation have been identified. these include perceived or actual lack of expertise, time, and resources, as well as lack of physician and patient engagement. one way to address patient engagement is education through character driven animation and we are currently trying this approach. a-s - low vs . high hemoglobin trigger for transfusion in vascular surgery (tv): a randomized clinical feasibility trial (the tv trial) background: current guidelines advocate to limit red-cell transfusion during surgery, but the feasibility and safety of such strategy remains unclear as the majority of evidence is based on postoperative stable patients. aims: we assessed the effects of a protocol aiming to restrict red-cell transfusion during elective vascular surgery. methods: fifty-eight patients scheduled for lower limb-bypass or open surgery of abdominal aortic aneurysm were randomized to a low-trigger (hemoglobin < . g/ dl, mmol/l) vs. high-trigger (hemoglobin < . g/dl, mmol/l) for red-cell transfusion throughout hospitalization. intraoperative change in cerebral-and muscle tissue oxygenation was assessed by near-infrared spectroscopy. we used a nationwide registry to collect data on death and major cardiovascular events, which encompassed ( ) severe adverse transfusion reaction, ( ) acute myocardial infarction, ( ) stroke, ( ) new-onset renal replacement therapy, ( ) vascular reoperation, and ( ) amputation of the lower limb. results: the primary outcome, mean hemoglobin within days of surgery, was significantly lower in the low-trigger group: . g/dl vs. . g/dl in the hightrigger group (mean difference . g/dl; p = . , longitudinal analysis) as were units of red-cells transfused ( background: controlled non-hemato-oncological studies have consistently demonstrated a single-unit red blood cell (rbc) transfusion policy as well as a stringent hemoglobin (hb) rbc transfusion threshold to be safe and reduce blood product utilization. yet, it is unclear whether these conclusions also apply to the hemato-oncological patient population. aims: to quantify reduction of rbc blood product utilization by the introduction of a restrictive single-unit hb-triggered rbc transfusion policy among the inpatient hemato-oncological population. methods: under the liberal transfusion protocol, applied up till november , , standard double-unit rbc transfusion was indicated with a hb threshold ≤ . g/dl and/or anemia-related symptoms. following this date, the restrictive transfusion protocol was introduced involving a lowering of threshold to . g/dl and single-unit transfusion. for patients with an asa-score of ii-iii and iv, a hb threshold of respectively ≤ . g/dl and ≤ . g/dl applied. we evaluated rbc blood product utilization over a month period starting december , (liberal protocol) and december , (restrictive protocol) in all hemato-oncological patients admitted for chemotherapeutic treatment including hematopoietic stem cell transplantation (hsct) with an expected duration of neutropenia of ≥ days. analysis of categorical and continuous data was performed using the chi-square and mann-whitney test, respectively. results: during both observational periods, patients were admitted who in total received therapy cycles, including acute myeloid leukemia (aml) induction cycles and autologous hscts. distribution of indications of admittance, median age, duration of hospitalization and duration of neutropenia did not differ between both periods. during the restrictive period, in / ( . %) of transfusions the assigned hb trigger was adhered to. the percentage of single-unit transfusion episodes increased from / ( . %) to / ( . %) with the introduction of the restrictive protocol. overall, rbc blood product utilization per admittance did not reduce under the restrictive protocol (cumulative number of transfused rbc units . (interquartile range (iqr) . - . ) during the liberal versus . (iqr . - . ) during the restrictive period (p = . )). however, rbc blood product utilization per neutropenic day demonstrated a trend towards reduction: . (iqr . - . ) versus . (iqr . - . ) units per day during the liberal versus restrictive period, respectively (p = . ). this reduction was mainly attributed to autologous hscts during which rbc blood product utilization decreased from . (iqr . - . ) to . (iqr . - . ) units (p = . ), corresponding to a reduction from . (iqr . - . ) to . (iqr . - . ) (p = . ) units per neutropenic day. moreover, / ( . %) patients during the liberal versus / ( . %) during the restrictive period did not require rbc transfusion during admittance. consequently, stringent hb thresholds as compared to single-unit transfusions seem to more strongly impact rbc blood product utilization. summary/conclusions: a hb-triggered single-unit transfusion policy results in a strong reduction of rbc blood product utilization in the setting of autologous hsct. no utilization reduction was observed among other hemato-oncological inpatient populations receiving intensive chemotherapy. further improvement of protocol adherence rates could potentially increase the benefit of this blood saving strategy. a-s - assessment of hb content of packed red cells (prbc): is it time to label each unit with hb content? r jain , n marwaha and s sachdev transfusion medicine, aiims, new delhi transfusion medicine, pgimer, chandigarh, india background: in the current era of evidence based medicine and individualized care of patients, rbc transfusion continues to be administered on the basis of conventional wisdom and the notion of an average benefit per unit. the existing blood transfusion practice based on the "number of units transfused" ignores the fact that the total hb varies markedly among the individual rbc units. aims: the present study was aimed at estimating the hb content in packed red cell unit prepared by three different protocols from ml and ml whole blood collection in three types of blood donors: replacement blood donor (rd), first time voluntary donor (ftvd) and regular voluntary blood donor (rtvd). methods: a total of prospective blood donors were included in this study. three hundred whole blood collections were performed in each of the three groups of donors (rd, ftvd, and rtvd). within each group collections were done in double ml, triple ml and quadruple ml blood bags respectively. a pre-donation venous sample was drawn from sample collection pouch for analysis in hematology analyzer as reference method for hb concentration of donor. the hb content of packed red cell units were estimated after collection of representative sample from the blood unit. volume of prbc unit was estimated by the formula of weight of blood in prbc divided by specific gravity. the hb content in unit was estimated by the formula: hb content in unit = hb value of the prbc unit (g/dl) volume of prbc unit (dl). results: in this study the hb concentration (g/dl) was comparable among three types of blood donors except that rtvd had lower hb values when compared to rd (p = . ). hemoglobin concentration of prbc ranged from . - . g/dl; mean hb was . ae . g/dl. net hb content of prbc bag was lower in prbc prepared from rd as compared to ftvd (p = . ) and rtvd (p = . ). the hb content of prbc units prepared from ml collection ranged from . - . g and from ml collection ranged from . - . g. we observed a wide range of net hb content in the prbc units and the correlation coefficient showed the strongest association of net hb content of the prbc unit with the overall volume of prbc (r = . , p = . ).higher volume prbcs have more hb content. volume of prbc bags in the study ranged from ml to ml (including both and ml collections). summary/conclusions: the present study shows that labelling hb content of the prbc unit help in better inventory management for patients. the hb content may help in decision making for release of units for paediatric/low weight versus adults/ higher weight patients. adopting a policy of optimizing dosage of rbc transfusion could have the potential to significantly improve rbc utilization and decrease patient exposure to allogenic blood. this would help further in the clinical transfusion practices based on evidence. a-s - nv more, p desai, s rajadhyaksha, a navkudkar and n deshpande transfusion medicine, tata memorial centre, homi bhabha national institute, mumbai, india background: red blood cell (rbc) transfusion is an important medical therapy benefiting the patient in a wide spectrum of clinical setting. critically ill intensive care unit patients in particular, as well as medical and hemato-oncology patients, are among the largest group of the user of rbc. periodic review of blood components usage is essential to assess the blood utilization pattern in any hospital or health care set up. our institute is a bedded tertiary care oncology centre with approximately , to , rbc transfusions annually. these transfusions are required in various stages of patient treatment like chemotherapy, radiotherapy, surgical and palliative care and there are established guidelines by the institute to be followed by clinicians. aims: to study clinical practices of rbc transfusions based on indications and to evaluate appropriateness of rbc utilization practices at the institute. methods: this was a prospective observational study, started after approval from institutional ethics committee. total of rbc transfusion events in adult patients over a period of four months were included and analyzed as per institutional guidelines for their appropriateness. details of transfusion events in form of pre transfusion hemoglobin, indication of transfusion, type of request, number of unit requested and issued, time of issue, site of transfusion and adverse reactions, etc were obtained from department of transfusion medicine records. overall statistical analysis was descriptive using spss software. chi-square test in cross tables was applied to see the relationship between different variables and considered significant if p-value was < . . results: total rbc transfusion events for patients were analyzed. there were ( %) events in patients of medical oncology and ( %) in patients of surgical oncology. maximum transfusions were received by patients in age group of to years ( %). total % of transfusion events were appropriate as per institutional guidelines. all transfusions administered in operation theatre were found to be appropriate with p value < . . inappropriateness was more %( / ) and significant in daycare setup (p < . ). anemia was the most common indication of rbc transfusion observed in % of events ( / ). total % rbc transfusions were given as planned and % as urgent transfusions. most common adverse transfusion event observed was allergic reaction in . % of total transfusion reactions. summary/conclusions: clinical practice of rbc transfusions in our hospital was largely found to be appropriate and rational with adherence to institutional guidelines. blood utilization audits should be conducted regularly by transfusion services and results should be discussed with clinician for ensuring judicious use of the scarce resource. the concept of transfusion safety officer (tso) can be introduced for better coordination between clinicians and blood transfusion services to improve practices. a-s - paul-ehrlich-institut, langen, germany on a global scale, blood services are quite diverse in regard to aspects like organisational structure, regulatory background, donor populations, donation rates or pathogen epidemiology. the world health organization (who) recognizes blood and blood products as essential medicines and provides guidance to member states for various aspects like blood regulation, best practices in blood collection and transfusion, or screening parameters. more recently a who guideline on residual risk of transfusion associated infections has been established which may facilitate decision-making for the most appropriate screening algorithms. it emphasizes the need for regional evaluation of screening assays and regulatory control of blood-associated ivds. background: babesia, a protozoan parasite that infects red blood cells, is a leading infectious cause of mortality in u.s. transfusion recipients. babesia is usually transmitted through the bite of an infected tick but may be transfusion transmitted (tt) or transmitted from mother to child during pregnancy. babesiosis is a world-wide disease; the ticks that carry babesia have a global distribution. babesiosis has been reported throughout europe and in canada, korea, india, and japan. prospective testing of blood donations in endemic areas of the u.s. revealed . % of donors were positive for babesia dna or antibodies (moritz, nejm, ) aims: -to report results of ongoing babesia clinical trial -to explain significance of babesia as a tt infection methods: in cobas â babesia for use on the cobas â / systems, is a qualitative polymerase chain reaction nucleic acid amplification test, developed to detect in whole blood (wb) donor samples the babesia species that cause human disease: b. microti, b. duncani, b. divergens, and b. venatorum. testing began in october under a u.s. fda-approved investigational new drug application. wb was collected into a proprietary medium that lysed red blood cells and stabilized babesia rna and dna. donations were collected in states with high, low, and no babesia endemicity and screened as individual blood donor (idt) samples. reactive index donations were retested in simulated minipools of (mp ), plus idt replicates with cobas â babesia. reactive index donations were also tested with validated alternate babesia nat and for b. microti igm and igg antibodies. donors with reactive results were invited to enroll in a follow-up study to test for additional evidence of infection. results: to date, , valid donations have been screened with cobas â babesia, and ( . %) were reactive. of ( %) initially-reactive donations were confirmed to be positive for babesia with a positive alternate nat or serology result. of ( %) confirmed-positive donations was collected in a state with low babesia endemicity (pennsylvania), and ( %) was collected in a state where babesia is not considered endemic (iowa). of ( %) confirmed positive donations were collected in states with high endemicity. of ( %) confirmed babesia-positive donations were detected in late fall or winter. all ( %) confirmed babesia-positive donations were reactive in mp . serology results are available for of confirmed-positive donations: at index, of confirmed babesia-positive donations were only igg-positive, while none were only igm-positive; were positive for both igg and igm. of the confirmed-babesia positive donations were negative for both igg and igm antibodies. cobas â babesia showed an overall specificity of . % ( , / , ; % exact ci: . %> %). summary/conclusions: the cobas â babesia test successfully identified babesiapositive donations, including confirmed-positive donations with no igm or igg reactivity. donations were collected in states considered low-or non-endemic for babesia. confirmed-positive donations were collected outside of the summer babesia season, when most clinical cases occur. screening with cobas â babesia continues in several laboratories. cobas â babesia is not fda licensed or available commercially. background: babesiosis in humans is caused by the erythrocytic protozoan parasite, babesia microti which is transmitted by tick bites, but is also transfusion transmitted. although frequently asymptomatic or presenting with flu-like symptoms in a normal host, if immunocompromised infection can lead to severe complications and death. b. microti is endemic in the north eastern/upper midwest united states where partial testing of donations has been implemented. in canada, a study of~ , donors did not identify any b. microti antibody-positive samples, suggesting low risk at that time, but risk should be monitored. aims: to evaluate the prevalence of b. microti-positive donations in potentially atrisk areas in canada. methods: between july and november , , blood donor samples were selected from sites near the us border. minipools were tested for b. microti nucleic acid by transcription mediated amplification (tma) using the procleix â babesia assay on the panther â system with individual testing on reactive pools. reactive donations were also tested by b. microti-specific: american red cross (arc) igg immunofluorescence assay [ifa] and imugen ifa/pcr. a subset of , tma-negative samples, primarily from the province of manitoba and eastwards to nova scotia, were tested for b. microti antibody using the arc ifa and if positive, the imugen ifa/pcr. donor age, sex, donation status, residential location and collection site location were recorded. donors who tested reactive/positive were informed, deferred and asked about risk factors (possible tick exposure and travel within canada, the usa and elsewhere, history of symptoms) and a follow-up sample was requested for supplemental testing (tma, arc ifa). reactive donations were removed from inventory. results: the , donor samples were proportional to collections in target geographic regions. age group, sex and donation status were also similar to the donor base in the collection areas. one sample from winnipeg, manitoba was tma reactive and antibody positive on supplementary testing. the donor did not remember symptoms or spending time in wooded areas. he visited the city of fargo, north dakota, usa. the subset of , samples tested for antibody were also proportional to collections in the targeted areas. four antibody-positive samples were identified from mid-september to october , all in south western ontario near lake erie. none were tma reactive. three were interviewed and none remembered any symptoms, any likely tick exposure, or relevant travel within canada or the usa. summary/conclusions: this is the largest b. microti prevalence study in canada. the results indicate very low prevalence with only tma-confirmed-positive donation of , tested. the donor was from the only region in canada where one autochthonous human case has been reported and active tick surveillance identified b. microti positive tick populations. seropositive donations in south western ontario may suggest low prevalence in that region, but interpretation is less certain due to lack of corroborating supplementary results or case history. given the close proximity to the us border, forgotten us travel should not be ruled out. a-s - background: the protozoan parasite toxoplasma gondii is prevalent in animals and humans worldwide. wild and domestic felids are the definitive hosts, and homoeothermic animals serve as the intermediate ones. after primary infection, the parasite persists lifelong within latent tissue cysts. transmission is by ingestion of undercooked or raw meat infected with cysts, by ingestion of food or water contaminated with oocysts, or transplacentally. however, it can also be acquired by blood transfusion and organ transplantation. toxoplasmosis can be a severe disease in immunosuppressed people and neonates whose mothers have acquired primary infection during pregnancy. aims: there is no information about the specific epidemiology of t. gondii infection in blood donors in portugal. therefore, we sought to determine the seroprevalence of t. gondii and associated risk factors in the population of blood donors in portugal. methods: between september and july , blood donors who attended the portuguese blood and transplantation institute blood banks located in oporto, coimbra and lisbon, and also at regional blood collection meetings, were invited to participate in the study. a written informed consent was obtained and a questionnaire about socio-demographic and behavioural variables was answered. sera were assessed for igg antibodies to t. gondii by a modified agglutination test (mat) commercial kit (toxo-screen da â biom erieux, lyon, france). results: of the blood donors (mean age . ae . ; range - years old), . % were positive for antibodies to t. gondii. when questioned about toxoplasmosis, almost half the blood donors did not have any knowledge about the disease. the centre of portugal had the highest seroprevalence ( . %) followed by the north ( . %) and the south ( . %). blood donors living in rural areas had a significantly higher seroprevalence (p = . ) than those living in urban areas. seroprevalence increased with age, with the highest seroprevalence ( . %) found in the age group of - years old (multiple logistic regression [mlr]: or = . ; ci: . - . ; p < . ), and decreased with educational level (p < . ). engaging in soil-related activities (gardening or agriculture) was significantly related to t. gondii seropositivity (p = . ). regarding water consumption, untreated sources (even though including mineral and tap water) was confirmed as a risk factor (mlr: or = . ; ci: . - . ; p = . ). other behavioural and eating characteristics, including cats in the household, eating raw or undercooked meat, processed pork products, or not washing raw fruit and vegetables before eating, were not associated with t. gondii infection. summary/conclusions: the risk of t. gondii transmission through blood transfusion is low, and serologic testing of antibodies, with exclusion of blood donors, appears not to be feasible. immunosuppressed individuals, organ transplant patients and pregnant women, should receive t. gondii antibody-negative blood components for transfusion. this study explored the epidemiology of t. gondii in portugal thus providing useful information on the seroprevalence and potential risk factors for t. gondii transmission. information regarding toxoplasmosis and its prevention could be promoted by medical and public health authorities among blood donors, and also the general population, when addressing policies, and designing screening programs, for monitoring and controlling infection and disease in portugal. a-s - who is syphilis testing excluding? c reynolds , c pearson , k davison and s brailsford nhsbt/phe epidemiology unit, nhs blood and transplant nhsbt/phe epidemiology unit, public health england, london, united kingdom background: screening for treponemal antibodies to detect syphilis in blood donors has been in place in england since the s. there have been no reported syphilis transfusion transmissions in england since records began in part due to sensitivity of the organism to cold storage. since we have specific tests in place for other sexually transmitted infections such as hiv and hepatitis b virus (hbv), the utility of syphilis screening is often questioned. however, it may be a useful proxy for higher risk behaviours particularly following shortening of deferrals for higher risk sexual behaviours from to months in november and against a background of increasing infectious syphilis in the general population. aims: here we describe the epidemiology of recently-acquired syphilis in blood donors in england compared with hiv and acute hbv infection between and . methods: monthly donation testing results are collected from the nhs blood and transplant (nhsbt) screening centres and reference laboratory. the demographics, possible sources of infection, and compliance to donor selection in confirmed positive donors are collected by proforma at post-test discussion with the nhsbt clinical team. recent syphilis is classified as igm positive and/or recent history including a negative donation within months for regular donors. results: between and there were recent syphilis cases, hiv and acute hbv infections identified by donation screening. recent syphilis rates per , donations increased from . to . whereas hiv decreased from . to . with less than positive donations in . acute hbv rates rose slightly from . to . in . males outweighed females accounting for . %, . % and . % of cases of recent syphilis, hiv and acute hbv respectively. nearly a quarter of cases of recent syphilis and hiv were seen in donors below years old. of the male donors with recent syphilis, . % reported sex between men and women (sbmw), . % sex between men (sbm) and . % did not report a risk. this contrasted with hiv where . % of male donors reported sbm, just . % not reporting a risk. overall , and males with recent syphilis, hiv or acute hbv respectively were non-compliant to the sbm deferral in place at the time of donation. in , donors with recent syphilis aged - years (median years) were excluded from the donor pool, including non-compliant to the sbm deferral. there were fewer than hiv cases identified in , all over years old, all compliant, reporting sbmw. of the hbv acute cases in , were male, all but one in the and over age-group. summary/conclusions: over the year period demographics of recent syphilis cases appeared similar to hiv with highest rates in young males, albeit lower proportions reporting sbm. following the switch to a month deferral, hiv case detection continued at low level, while syphilis screening continued to exclude higher numbers spanning all age-groups, potentially at risk of other sexually transmitted infections, including non-compliant donors. background: globally, an estimated million blood donations are given annually. in the blood service we are obliged to monitor donor health and ensure that blood donation is safe. in recent years, large-scale blood donor cohort studies in several countries have increased our knowledge on health effects of blood donation. health concerns relate both to immediate side effects like fainting and to possible long-term health issues related to repeated blood or plasma donation. the studies have provided us with data that can now help us introduce an evidence-based individualised donor care -a parallel to personalised medicine. individualised donor care in the management of iron depletion: studies have shown that a large percentage of our frequent whole blood donors, especially young women, are iron depleted. iron depletion is a strong predictor of deferral for low haemoglobin but has also been associated with e.g. restless legs syndrome and lower birth weight in children of frequent donors. the risk of iron deficiency can be mitigated by ferritin-guided prolongation of interdonation intervals or by iron supplementation. prolongation of interdonation intervals can challenge our inventories. iron supplementation, on the other hand, may give gastrointestinal side effects and other effects have been proposed as well, e.g. the masking of malignant disease and increased iron availability with subsequent risk of infection. in a large study we found that iron supplementation is not associated with increased risk of infection. what is the optimal balance between iron supplementation and prolongation of interdonation intervals? a growing number of blood services have implemented various flavours of iron management regimens generating more results. moreover, genetic studies in e.g. the uk, us, holland, and denmark can help us to find donors at high risk of iron depletion or low haemoglobin. we can use all these data in a big data approach in the pursuit of an individualised risk assessment model. other risks for blood donors: the presentation will also cover other risks associated with donation. new studies identify predictors of fainting after blood donation and also new interventions to prevent fainting. the global demand for plasma derived medicinal products has increased severalfold the last years. plasma donors are bled up to times per year in the us. very little is known about the health effects of frequent plasma donation. we know that immunoglobulin levels decrease with frequent donation but how does this affect health? summary/conclusions: the precautionary principle mitigates risk through early intervention prior to evidence. we tolerate next to no risk of transfusion-transmitted infectious diseases. the health of the blood donors, however, has not been protected similarly. we owe to our whole blood and plasma donors to investigate health effects of blood donation and ensure their safety. while the first attempts may not be perfect, we now have the tools to construct models for individualised donor care. background: in , the isbt, aabb, ihn and eba jointly issued the standard for surveillance of complications related to blood donation which categorized donor adverse events (dae) into categories ( subcategories) defined by specific criteria. severity and imputability were briefly described but were optional. subsequent validation of these categories demonstrated consistency in categorizing reactions, but wide variation in assignment of severity. in , with international input, the aabb donor biovigilance committee developed a severity grading tool (sgt) using a recognized medical adverse event grading system in which neutral grades replace subjective terms (mild, moderate, severe). aims: a large us blood collection establishment (bce) applied the draft sgt to assess its use in real cases of dae. methods: we performed retrospective analysis of all allogeneic and apheresis needle-in donations between / / to / / . severity grading was assigned based on criteria defined by the sgt. database review of dae was performed, and each event was assigned a grade based on the type of outside medical care (omc), and on specific key search terms. search terms for omc included emergency room, emergency medical response, urgent care, healthcare professional, and hospital admission. additional specific key search terms included fracture, concussion, laceration, dental injury, surgery, and hospitalization. since duration and activities of daily living (adl) limitations were not captured in our dae database, cases in our dae claims' database were reviewed. case files of events classified as grade or higher were individually evaluated by a physician for grading accuracy. results: in , , needle-in collections, , dae were graded for severity. the majority ( , , . %) were vasovagal reactions (vvr), followed by , apheresis-related ( . %), , needle-related ( . %) and allergic ( . %) events. the majority of dae were grade accounting for . % of all dae, followed by grade ( . %), and grade ( . %). there were grade and no grade dae. among the vvr, . %, . %, . % and . % were grade , , , and respectively. grade vvrs included concussions, fractures, dental injury, and pre-faint and fainting events requiring hospitalization for work-up. two grade vvrs involved falls resulting in intracranial hemorrhage requiring immediate medical intervention. for allergic and apheresis dae, there were only and grade reactions respectively, and no grade or events. needle-related dae included . % grade , . % grade , . % grade , and no grade events. of the six grade needle-related dae, were nerve irritations lasting > months, and were dvts requiring hospitalization. summary/conclusions: the sgt provided consistent assignment of severity for the majority of dae, based on outside medical care and specific key search terms. assignment of severity based on impact on activities of daily living or on duration of injury/condition requires tracking over time making such assignments more difficult; modification of our dae tracking database and claims database to capture adl and duration should improve severity assignment for such cases. background: the international haemovigilance network (ihn) has collected aggregate data on complications of whole blood and apheresis donations from member national haemovigilance systems (hvs) since . aims: we analysed the data collected in - in order to learn from the data and consider future improvement of data collection. methods: national hvs entered annual data on donor complications in the passwordprotected "istare" (international surveillance of transfusion adverse reactions and events) online database. from the donor complication spreadsheet allowed entry of separate data for whole blood donation (wbd) and apheresis, but also provided an option for entering data for all donation types. annual numbers of whole blood and apheresis donations were also collected. the harmonised international standard definitions were implemented in . reactions were captured according to severity level (mild, moderate, severe) but without distinction between donor sex or first time vs repeat donation. extracted data were used to calculate national and aggregate donor complication rates (generally per donations). results: twenty-four hvs provided figures for donations and donor complications for one or more years (median years per country was , iqr - ). the total number of country years (cy) was , covering million donations. the overall complication rate was . / donations and the median country rate was . complications/ donations (iqr . - . ). rates were generally consistent within a hvs from year to year but showed considerable variation between hvs; this was also the case for reactions classed as severe. not all countries differentiated between mild and moderate reactions and some reported all reactions under a single severity level. vasovagal reactions were the most commonly reported complication: overall . / donations, median country rate . / donations (iqr . - . ). rare and apheresis-related types of complications such as generalized allergic reaction ( . per , , cy), and major blood vessel injury (category available since ; overall . per , , cy) were only reported occasionally. eighteen of the hvs provided separate data for complications of whole blood and apheresis donations in one or more years (total cy, . million wbd and . million aphereses, total million donations). for these hvs the median rate of vasovagal reactions was . / wbd (iqr . - . ) and . / apheresis procedures ( . - . ) . reported haematoma rates were higher for apheresis than for wbd: the median per hvs was . / wbd (iqr . - . ) vs . / aphereses ( . - . ); rates of arm pain and/or nerve injury (not separated in - ) also tended to be higher: median . / with wbd, iqr . - . , vs . / with apheresis, . - . . summary/conclusions: international reporting allows hvs to study rates of blood donation complications, to distinguish between wbd and apheresis complication rates and capture information about very rare events. variability of reporting and of severity assessment between countries impairs the feasibility of comparisons between hvs. work is needed to improve harmonisation of classification of donation complications and severity assessment for data comparison and research. background: to prevent iron related hb loss, screening with ferritin testing was implemented in stockholm county (approx. registered blood donors) during a two-year roll-out. iron supplementation is offered to blood donors but has not prevented hb deferrals resulting in control visits per year. ferritin testing is hypothesized to increase iron compliance. aims: implementation of ferritin testing for surveillance of iron levels for the entire blood donor population with specific attention to new donors, women returning after pregnancy, donors with low hb and at return visit after low hb. yearly testing of plasma and platelet donors. methods: ferritin testing, following a staff education program, was implemented for applicant donors, donors with low hb, women after pregnancy, apheresis donors, followed by screening of registered blood donors per donation site. after initial screening, donors will be tested at each th (women) or th (men) donation, and with yearly testing of young adult blood donors below years. six nurses were educated to process ferritin and blood count results. donors with aberrant ferritin were contacted by letter. results: establishment of cut-off levels and algorithms for ferritin testing and iron treatment was evidence based but met practical limitations such as number of analyses and results that could be processed per week, limitations in liss set-up, blood demand contra preferred cut-offs, iron supplementation compliance. for applicant donors, hb testing show that % of female and % of male applicants cannot be registered because of low hb ( and mg/l respectively). adding ferritin testing, a preferred cut-off level of lg/ml (male reference level), would result in additionally % female and . % male applicant donor loss. as this would threat the blood demand, cut-off was set to lg/ml for women, above the female reference lg/ml, with an acceptable % loss of female applicant donors. for registered blood donors, mg of extra iron tablets were offered at low ferritin ( - lg/ml). this was sometimes combined with prolonged intervals and often repeated before ferritin was restored above lg/ml. donors with ferritin below lg/ml (in . % applicant donors, . % registered donors) or above lg/ml ( . % applicant donors, . % registered donors) were deferred and recommended to see their physician. for hb deferral, the interval was prolonged from to months, irrespective of ferritin levels. this, together with iron supplementation, resulted in an increase from % to % approved hb at return. the team of nurses processing ferritin and blood count results ( ½ nurse fulltime weekdays) reacted to approximately donor results daily, representing % of test results. summary/conclusions: many female donor applicants have suboptimal ferritin levels although they meet required hb for donation. iron treatment was added to retain donors with low ferritin as only prolonged intervals may danger the blood supply. for implementation of ferritin testing, it is necessary to have a well-functioning and agile organization to create and apply algorithms for testing, extension of intervals and iron treatment. background: since november a new donor screening regime is introduced in the netherlands where serum ferritin levels in whole blood donors are measured periodically to further control potential iron deficiency in donors. donor deferral thresholds are set at and ng/ml, and donors are deferred for six and twelve months respectively if ferritin levels are below these values. as limited information is available on ferritin recovery in whole-blood donors, the policy is introduced in parts such that adaptations to the implementation may be considered based on intermediate results and the impact of the measure on donor well-being can be evaluated. aims: to assess the effect of donor deferral on donor ferritin levels. methods: ferritin levels are measured in new donors and at every fifth donation in repeat donors. donors with ferritin levels below the indicated thresholds are deferred and ferritin is re-evaluated at their return for donation after six or twelve months. the policy allows estimating long term trends in ferritin levels post donation in repeat donors. as ferritin levels are measured in all new donors a reference distribution of ferritin levels in healthy individuals is obtained as well. results: among repeat donors % ( % of , male donors, and % of , female donors) have ferritin levels below ng/ml and are deferred for their next donation. furthermore, the distributions of ferritin levels in repeat male and female donors are similar and each has an average ferritin level of ng/ml. in contrast, we found that only % of new female donors (n = , ) and . % of new male donors (n = , ) have a ferritin levels below ng/ml. the average ferritin level in new donors was ng/ml for males and ng/ml for females. comparing the ferritin levels in new and repeat donors, a reduction in average ferritin levels between . and . was observed in female donors and between . and . in male donors. both ratios increased with donor age. at the end of december donors with low ferritin levels returned for donation after six or twelve months deferral. repeat ferritin measurements show that on average the ferritin levels in female donors increased by ng/ml per year whereas average ferritin levels in male donors increased by ng/ml per year. summary/conclusions: in line with earlier findings in literature our results show that repeat donations substantially reduce ferritin levels in repeat donors. these range from . to . in female and from . to . in male donors, who generally have higher ferritin levels. deferral of donors with low ferritin levels seems to be effective in increasing ferritin levels in donors, however, further monitoring of follow-up in repeat donors is warranted to see whether the proposed scheme allows for sufficient donor recovery over time. there are~ different rare diseases and the genes for half have been identified. approximately . million uk citizens experience premature ill-health because of a rare disease. a conclusive diagnosis is generally not reached and on average the diagnostic odyssey lasts . years. the main aims of the , genomes project are to reduce the diagnostic delay by embedding whole genome sequencing (wgs) to accredited standards in the care path of patients with undiagnosed rare diseases. the project started in and dna samples from , nhs patients and their close relatives have been analysed by wgs. here we review the results from the nihr bioresource pilot study for the , genomes project comprising phenotype and genotype data from , individuals recruited at hospitals using approved eligibility criteria for rare disease domains. we determined the population structure including ethnicity and relatedness estimation, high level phenotypes collected using human phenotype ontology (hpo) terms and quality control and summary metrics for samples and variants. the sequence resource contains over million unique variants in the , genetically independent samples, with % of variants previously unobserved in other large scale publicly available genome datasets. we summarise the curation of gene lists and pertinent findings in , unique diagnostic-grade genes for the domains. over , reports assigning pathogenic or likely pathogenic causal variants have been issued with diagnostic yields varying between domains from . % to %, while the proportion of novel causal variants ranged between % and %. we show the power of the bayesian association test, bevimed, to recapitulate decades of clinical genetics discoveries and by identifying > novel genes and novel diseasecausing variants in the non-coding space of the genome. we show how typing data for all red cell, hpa and hla class antigens can be extracted from wgs data. we mined the data from the , genomes project and similar sequence resources to re-version the probe content of the uk biobank axiom array. we genotyped donors from england and the netherlands with this new array and observed a . % concordance when comparing , blood centredetermined antigen typing results with genotype-determined ones. for the red cell and hpa antigens that were available for , donors, the array typing provided a . -fold increase in typing results per donor ( . vs . ) and rare donors were identified. using the genotyping data we identified . times more compatible units among this cohort of donors when blood demand was modelled using referral data from , english patients with more than three red cell alloantibodies. in conclusion the , genomes project has shown the feasibility of using wgs across a universal healthcare system to deliver a diagnosis for patients with rare diseases. based on these results the nhs has commissioned the analysis of another , dna samples from patients with cancer and rare disease. with analysis of dna by wgs and arrays becoming part of routine clinical care, blood services must develop competencies to extract transfusion and transplant relevant information from clinical-grade genotyping data. next-generation sequencing (ngs) enables the sequencing of thousands of genes, the exomes, and even entire genomes by single experiments at a reasonable price. there have also been advances in cytometry: use of antibodies with different fluorescence tags enables simultaneous monitoring of the expression of dozens of antigens. however, immunological methods cannot detect every variant discovered by ngs. genome sequencing reveals not only the exome but also the regulatory elements of transcription/translation, such as promoters and enhancers. rna sequencing determines which genes and spliced transcripts are expressed. it is amazing to realize how much this novel technology has been contributing to the better understanding of various biological phenomena. since the initial cloning of the human blood group a transferase cdnas in the early s, we have been studying the abo genes, a and b glycosyltransferases, and a and b oligosaccharide antigens. various scientific disciplines including genetics, immunohematology, biochemistry, enzymology, and glycobiology have been applied to their study. we have made several important scientific contributions. we demonstrated the central dogma of abo: the a and b alleles at the abo genetic locus encode a and b transferases, which synthesize a and b antigens, respectively. we elucidated the allelic basis of the abo system. we found amino acid substitutions between a and b transferases and inactivating mutations in o alleles. we became the first who succeeded in the abo genotyping, discriminating the aa and ao genotypes, as well as the bb and bo, which was impossible by the immunological approach. we have taken a simple experimental strategy: preparation of eukaryotic expression constructs of a/b transferases and their derivatives, dna transfection to human hela cells or their sublines, and immunological detection of the a/b antigen and/or biochemical examination of the enzymatic activity. we used this to show that the codons and are crucial in determining the sugar specificities of galnac/galactose of a/b transferases. we also identified mutations in several subgroup alleles causing restricted substrate use and diminished transferase activity. we also showed that cis-ab and b(a) alleles specifying the expression of both a and b antigens by single alleles encode a-b transferase chimeras. since then, other scientists have characterized more than abo alleles. recent human genome sequencings have identified many more single nucleotide polymorphism variations. the genome sequences of many species are also available. taking advantage of those sequences and associated information, we have expanded our research to include evolutionarily related a , -gal(nac) transferases and their genes and scaled it up from the genetic to genomic level. in this talk, i would like to present the followings. : our elucidation of the molecular genetic basis of the abo blood group system (as requested by the organizer); : identification of novel abo alleles by others; : more snp data from genome sequences and potential problems for abo genotyping; : findings obtained from analysis of abo genes from other species; bacteria, vertebrates, to primates; : a , -gal(nac) transferases and their genes and the crosstalk between a transferase and forssman glycolipid synthase (fs); and : the potential causes of generation of abo polymorphism and of species variations of the gbgt gene specifying the fors polymorphism. in recent years, there has been a concerted effort to improve our understanding of the quality and effectiveness of transfused blood components. the expanding use of large datasets built from electronic health records allows the investigation of potential benefits or adverse outcomes associated with transfusion therapy. together with data collected on blood donors and components, these datasets permit an evaluation of the effect of donor and blood component factors on transfusion recipient outcomes. large linked donor-component recipient datasets provide the power to study exposures relevant to transfusion efficacy and safety, many of which may not otherwise be amenable to study for practicality or sample size reasons. analysis of these large blood banking-transfusion medicine datasets allow for characterization of the populations under study and provide an evidence base for future clinical studies. knowledge generated from linked analyses has the potential to change the way donors are selected and how components are processed, stored and allocated. however, unrecognized confounding and biased statistical methods continue to be limitations in the study of transfusion exposures and patient outcomes. results of observational studies of blood donor demographics, storage age, and transfusion practice have been conflicting. this review will summarize statistical and methodological challenges in the analysis of linked blood donor, component, and transfusion recipient outcomes. c-s - a large deletion spanning xg xg and gyg gyg constitutes a genetic basis of the xg null phenotype, underlying anti-xg a production background: the xg blood group system comprises the homologous antigens xg a and cd . the cd gene resides within pseudoautosomal region on the short arms of the sex chromosomes and thus mimics autosomal inheritance. xg, on the other hand, is x-linked and straddles the pseudoautosomal boundary; a truncated pseudogene composed of only the first exons remains on the y chromosome and therefore males carry a sole full-length copy of xg. this phenomenon manifests as asymmetric frequencies of the xg(a+) phenotype between the sexes: roughly % of women and % of men are xg(aÀ). also, whilst xg a immunization is rare, the vast majority of all anti-xg a makers reported are men. recently, we reported that the rs c variant disrupts a gata motif between xg and cd . this abolishes erythroid xg a expression and causes the common xg(a-) red cell phenotype. however, rare individuals who produce anti-xg a cannot be accounted for by this finding. we hypothesized that a structural defect in the xg coding region causes the true xg null phenotype underlying anti-xg a production. aims: we undertook to determine a genetic explanation for anti-xg a production. methods: genomic dna (gdna) was extracted from two whole blood samples and cell-free dna (cfdna) from archived plasma samples from donors producing anti-xg a ; one cfdna sample was from a female donor and the rest from males. polymerase chain reaction (pcr) experiments, sanger sequencing, and database searches were performed to identify and confirm the deletion. aliquots of gdna from four males reported to carry a similar deletion in the genomes project were also tested. results: in one gdna sample, exon-specific pcr identified a deletion involving part of xg and the downstream gene gyg . database searches indicated that the most likely deletion was the infrequent genomic structural variant esv reported in the genomes project. further analyses with a short ( bp) and a long ( bp) pcr amplicon across the suspected breakpoint determined that this deletion was approximately kb and corresponded well with esv . this finding was confirmed in the second gdna sample. given the rarity of anti-xg a producers, we decided to test for the same deletion in cfdna extracted from old archived plasma samples. of the cfdna samples, poor quality in four samples prevented amplification even from control reactions and one was contaminated with bacterial dna. in the remaining nine samples, eight could be amplified for the deletion-specific -bp short amplicon while one was negative for the deletion. sanger sequencing of the amplicons revealed a heterogeneous repetitive dna element, ltr b, hinting at a previously-reported recombination event. this deletion was not detected in the samples from the genomes project which reiterates the previously identified deficiency in data interpretation and reporting for deletions. summary/conclusions: a large deletion disrupting the xg and gyg genes accounts for the xg null phenotype underlying the majority ( of ) of anti-xg a makers. one sample remained unexplained, indicating further heterogeneity to be explored. our data help to explain why anti-xg a production is rare and has primarily been reported in men. background: s and s antigens encoded by gypb differ by one nucleotide (nt), c. c>t, p.thr met. two different genetic backgrounds are associated with silencing of s antigen and a u+ w phenotype. these include the nt change c. c>t (p.thr met) causing partial exon skipping and designated gybp* n. (gypb*ny) and c. + g>t, an intron change causing complete skipping of exon , designated gypb* n. (gypb*p ). aims: samples from three individuals, a previously transfused african american sickle cell patient (p ), a blood donor of unknown ethnicity (p ), and an african american patient (p ) (lapadat r. aabb abstract) were investigated for discrepant serologic and molecular results when determining s and s phenotype. methods: standard methods were used for rbc typing with licensed s and s reagents and rbcs from donor p were also tested with monoclonal and polyclonal anti-s and anti-s. dna was isolated from wbcs and hea precisetype performed on p and p . p was also tested by gypb*s/s as-pcr, exon pcr-rflp for c. + g>t and as-pcr for c. c>t. p was tested for gypb*s/s and c. c>t and c. + g>t changes by a real-time pcr-fluorogenic ' nuclease taqman chemistry. for all, gypb exons - were amplified and sanger sequenced and aligned to consensus using clustal x. results: rbcs of all three probands typed s-and strongly s+ while dna testing indicated c. t/c (gypb*s/s). assay for the two common gypb*s silenced alleles, c. c>t and c. + g>t, indicated all three samples had both silencing mutations previously reported to be independently associated with a sÀu+ w phenotype. hea precisetype could not interpret this novel allele combination and indicated gypb*s as pv (possible variant). samples were confirmed to be heterozygous for c. c/t, c. c/t and c. + g/t by exon specific sequencing and as-pcr, pcr-rflp and real-time pcr. by long range sequencing of gypb, all three were heterozygous c. t/g and c. a/g (p. leu/trp), c. a/t (p. thr/ser), c. a/g and c. g/t (p. glu/gly), c. c/t (s/s), c. g/t (p. val/leu), c. c/t (p. thr/met), and c. + g/t. all samples were also c. g/g (p. ser) and heterozygous for several previously recognized silent changes in exon , c. t/c, c. t/c and c. a/g. summary/conclusions: we report a novel silenced gypb*s allele that can confound gypb genotyping interpretation. the allele was found in three probands associated with a sÀs+ phenotype. in these samples, two changes previously reported to be inherited independently and both associated with silencing of s antigen are carried on the same allele. dna-based testing could not rule out that c. t or c. + t are separate and that gypb*s was also silenced. robust s+ rbc typing indicates both changes are on gypb*s. gene sequencing confirms the c. + t change is on a gypb* n. [gyp*he(ny)] background. c. c>t (rs ) and c. + g>t (rs ) have a frequency of . respectively . in the african population (exac). although we identified samples, the frequency of this novel allele is unknown. background: the lutheran blood group system currently consists of antigens. these antigens are of low immunogenicity and may cause mild-to-moderate transfusion reactions and hemolytic disease of the fetus and newborn. the activation of lu-glycoprotein/bcam on red blood cells (rbcs) and its interaction with laminin- a is thought to play a role in vaso-occlusion in sickle cell disease and other hematological disorders. the two glycoprotein isoforms lu-glycoprotein and bcam are encoded by the bcam gene which consists of exons located on chromosome q . . a number of rare lutheran phenotypes have been previously recorded in israel, including lu:- , observed among iranian jews, lu:- in one thalassemia patient and one case of lu:- . in this report, a previously transfused pregnant arab patient with b-thalassemia intermedia was investigated because she presented with an antibody to an unknown high frequency antigen (hfa), potentially related to the lutheran system. aims: to characterize a novel lutheran antigen through serological and molecular investigation of a patient with a lutheran related antibody. methods: initially, the red cell phenotype and the presence of a lutheran related antibody in the serum of the patient were detected by standard serological techniques, utilizing enzyme treated and chemically modified cells and rare cells and sera from the nbgrl collection. further serological investigations were carried out using standard iat (liss tube and bio-rad gel) technique. plasma inhibition studies were performed using soluble recombinant lu protein (srlu). eluates were prepared using acid elution method (gamma elu-kit ii). genomic dna was isolated from whole blood and all exons of the bcam gene were amplified by pcr and directly sequenced by sanger sequencing. the impact of the identified mutation on lutheran glycoprotein structure was studied by molecular dynamics calculations. results: the patient's plasma reacted with all cells tested, except for three examples of in(lu) cells and cells treated with -aminoethylisothiouronium bromide, trypsin and a-chymotrypsin. inhibition studies with srlu protein showed complete inhibition of the antibody, thereby confirming the antibody to be directed toward an epitope on the lu-glycoprotein. in addition, testing of inhibited plasma revealed the presence of underlying anti-e and anti-fy a . an eluate was prepared to isolate the patient's lu-related antibody and this eluate was found to be incompatible with examples of lu:- , lu:- , lu:- , lu:- , lu:- , lu:- , and lu:- cells, whereas in(lu) were compatible. results of serological typing of the patient's cells, for lu system hfas, could not be conclusively determined due to the patient having been recently transfused. however, results suggested (through absence of mixed field reactivity) the patient's cells to be lu: - , , , , ,- , . bcam sequence analysis confirmed the patient to be lu* , lu* and revealed a novel homozygous mutation c. a>c in exon , encoding p.lys gln in the lutheran glycoprotein. summary/conclusions: a novel homozygous mutation c. a>c (p.lys gln) in exon of bcam was identified in a patient with an antibody to a lutheran hfa. serological and genetic evidence presented here indicates discovery of a novel antigen of the lutheran blood group system, which we propose to name lura. background: lutheran glycoprotein and basal cell adhesion molecule antigen b-cam are two isoforms of a type i membrane glycoprotein residing on red cell surfaces. both isoforms are adhesion molecules with the main function of laminin binding, and both carry antigens of the lutheran blood group system (lu). the system currently comprises antigens, all encoded by mutations in the alternatively spliced single gene bcam located on chromosome . currently, isbt lists high incidence antigens in the system. aims: we report a case study of an individual with an unidentified alloantibody to high incidence antigen present in her plasma. samples from the patient and her family were investigated. we provide here serological and molecular evidence for a novel high incidence antigen of the lutheran blood group system. methods: serological investigations were performed by standard iat (liss tube and bio-rad gel) technique. plasma inhibition studies were completed with soluble recombinant lu (srlu) protein. genomic dna was isolated from whole blood of the patient and her family members; all the exons of the bcam gene were amplified by pcr and analysed by direct sanger sequencing. the impact of the identified mutation on lutheran glycoprotein structure was studied by molecular dynamics calculations. results: presence of a lu-related antibody in the patient's plasma was confirmed, reacting moderate strength by liss iat with untreated and papain treated cells. cells from the patient's mother, father and two siblings were all incompatible with her plasma, though weaker than panel cells, reflecting dosage. only in(lu) cells were compatible with patient's plasma. the antibody was successfully inhibited with srlu protein, thereby confirming the epitope recognised by the antibody resides on the lutheran glycoprotein. the patient's cells were found to be lu: - , , , , , , , , . bcam sequencing revealed a novel homozygous mutation c. g>a in exon , encoding p.val met in the lu glycoprotein. the c. g>a change appears to be an extremely rare mutation, listed in gnomad database with a frequency of . - and with no known homozygous examples. homology model of the novel lutheran glycoprotein was subjected to all-atom molecular dynamics calculations to analyse potential conformational changes. summary/conclusions: we report serological and genetic evidence for a novel antigen of the lutheran system, which we propose to name lunu. the evidence will be submitted to the isbt red cell immunogenetics and blood group terminology working party for consideration for allocation of antigen status. the absence of this high incidence antigen arises from a rare single amino acid change p.val met in the lutheran glycoprotein and the presence of anti-lunu in the patients' plasma was presumed to have been made in response to previous pregnancy. on native, papain-treated (diagast) and trypsin-treated (sigma) rbcs. genomic dna was extracted from peripheral blood cells by an automated method, amplified by sema a exon-specific primers and sequenced. results: the proband was a -year-old female patient of moroccan origin, group a, d+c+e-c+e+, k-, without transfusion history. she was hospitalized at weeks gestation for a blighted ovum requiring a manual vacuum aspiration, with a significant hemorrhage risk. a rbc antibody screening was performed by a first laboratory. the antibody reacted + by iat on all native reagent rbcs, with negative autocontrols, but was nonreactive on papain-and trypsin-treated cells. an anti-ge was initially suspected, due to the pattern of reactivity and ethnic background. new blood samples were referred to our national immunohematology reference laboratory. the antibody showed the same profile. anti-ge and anti-ch could be ruled out. the serum was nonreactive with two jmh:- and positive with two jmh:- samples. the patient was found to be jmh positive. in addition, a soluble recombinant jmh protein (jmh imusyn/inno-train) fully abolished the reactivity of the panagglutinating antibody. the antibody was an igg . overall, these results were consistent with a probable jmh variant and prompted us to perform sema a sequencing. three nucleotide changes were found, in homozygous state: a rare nonsynonymous change in exon , c. g>a (p.asp asn, rs , maf < . , sift score = ); a common synonymous change in exon , c. a>g (p.gln gln, rs , maf = . ); a rare non-synonymous change in exon , c. g>a (p.arg his, rs , maf < . , sift score = . ). the analysis of surface accessibility of asp and arg using the d structure of sema a (rcsb pdb- nvq https://www.rcsb.org/structure/ nvq) showed that only arg was predicted to be an exposed-epitope. interestingly, all other reported jmh variant phenotypes correspond to an arginine substitution. of note, we retrospectively found another individual of algerian ancestry (pregnant woman) with a pan-agglutinating igg antibody showing a similar pattern of reactivity, and with the same three changes in sema a. we unfortunately could not perform a cross-compatibility testing with the proband (no material left and unsuccessful contact). summary/conclusions: serological and molecular studies allowed us to provide evidence for a novel high-prevalence antigen in the jmh blood group system, very likely encoded by the p.arg his substitution in sema a. we propose to provisionally assign the name jmh for this antigen. interestingly, our two unrelated jmh:- individuals were from north african ancestry. background: the abo system was discovered almost years ago and the underlying structures later elucidated as carbohydrates carried by glycoproteins and glycolipids. the terminal trisaccharides galnaca (fuca )gal and gala (fuca )gal constitute the clinically important a and b epitopes, respectively. clausen et al. (pnas, ) showed that the a antigen could be extended to a repetitive glycolipid a epitope, galnaca (fuca )galb galnaca (fuca )galb glcnac-r. however, extended forms of b antigen have not been described. we encountered two related situations with unexplained serological reactivity. firstly, enzyme-conversion to group o treatment of group b (b-eco) red blood cells (rbcs) with a -specific gh family exogalactosidase (bzyme) abolishes b antigens as detected by hemagglutination and flow cytometry with all monoclonal anti-b tested. despite this, % of group o plasmas have been reported to give positive crossmatch results with b-eco rbcs. secondly, plasmas from ab and b individuals of the globoside-deficient p k phenotype contain anti-p and anti-px but react stronger with bpp-rbc than with app/opp-rbc. based on these findings, we hypothesized the presence of a bzyme-resistant, b-related glycolipid. aims: to identify the molecular basis of the enigmatic serological observations outlined above. methods: plasma and eluates from an a b individual with the p k phenotype were investigated by hemagglutination and flow cytometry, as were eluates from b p k and o plasma. rbc membrane glycolipids were extracted from two batches of pooled, expired group b-rbc units (frozen -litre reference preparation and confirmatory preparation from freshly collected units). native or enzyme-treated glycolipid fractions were analysed by liquid chromatography electrospray ionizationmass spectrometry (lc-esi/ms) and immunostaining of thin layer chromatography (tlc) plates. antigen expression in the h+bÀ human erythroleukemia (hel) cell line was analysed by flow cytometry following overexpression of selected glycosyltransferases. results: anti-p-depleted eluates made from a b p k plasma contained anti-px and antibodies of unknown specificity that reacted stronger with native or papaintreated bpp-rbcs compared to app/opp-rbcs. anti-px was removed by adsorption onto opp-rbcs but reactivity (here designated anti-extb) remained against b/bpp/b-eco rbcs. lc-esi/ms of glycolipid fractions from group b units revealed an unknown hexnac-hex-(fuc-)hex- hexnac-hex- hex heptasaccharide. upon b-nacetylhexosaminidase treatment of this candidate structure, a group b type hexasaccharide was produced, demonstrating that the terminal hexnac of the hexnac-gala (fuca )galb glcnacb galb glc heptasaccharide was b-linked. since the discovery of the anti-platelet effects of aspirin platelets have been a major therapeutic target for pharmaceutical companies and also a very profitable target. however, the effectiveness of aspirin has also been a challenge as it is an inexpensive drug and any new agent needs to show clear benefit over aspirin. furthermore the risk of bleeding from anti-platelet agents, especially cerebral bleeds, has also presented challenges. in the 's orally active gpiib/iiia antagonists were considered to be the 'super aspirin' but clinical trials showed increased mortality and ultimately this class of drugs was relegated to iv use only in high-risk patients. gpib/ix/v antagonists were also a promising drug target but no agent made it to market. the real breakthrough was the discovery of the p y antagonist clopidogrel which, in conjunction with aspirin, proved to be very effective at preventing thrombotic events and as a result it became the biggest selling drug in the world at the time. with clopidogrel now offpatent the combination of aspirin and clopidogrel is a formidable challenge to any new agent both in efficacy terms and pharmacoeonomic terms. so is there a future for new anti-platelet agents? with the growing awareness of the role of platelets in inflammation and an understanding of how the immune activation of platelets differs from the classical haemostatic activation of platelets it is now possible to develop novel anti-platelet agents that target inflammation without compromising haemostasis. it is here that we should look for the next generation of anti-platelet agent. c-s - university hospitals of geneva, geneva, switzerland platelet function defects, either congenital or acquired, are associated with increased bleeding risk, particularly in a perioperative setting. the use of platelet function assays is therefore tempting in order to tailor transfusion and limit platelet transfusion to those bleeding patients with impaired platelet function, as assessed by those assays. however, the current guidelines provide only weak recommendations supporting the routine use of these assays. indeed, there are numerous platelet function assays on the market that differ in their method of evaluation of platelet function and agreement between their results is at best moderate. the threshold values beyond which procedure-associated bleeding risk becomes worrisome is not standardized. moreover, observational studies addressing the predictive value of platelet function testing in perioperative or spontaneous bleeding are not consistent. finally, management trials with randomized patients assessing the benefit of platelet function testing are scarce. more recent data identified selected situations where platelet function testing may be useful though. i will review the different platelet function assays as well as selected clinical studies addressing the impact of platelet function testing to improve bleeding and transfusion-related outcomes. the latest recommendation will be addressed too. background: platelet refractoriness complicates the provision of platelet transfusions in management of thrombocytopenia in oncology patients. platelet refractoriness poses challenge due to alloimmunization to hla and human platelet antigens and is associated with adverse clinical outcomes. aims: a prospective study was undertaken to analyse result of platelet compatibility with post-transfusion platelet count increment and to ascertain presence of platelet antibodies as causative factor in platelet refractory oncology patients. pulmonary complication after blood transfusion is the leading cause of transfusionrelated morbidity and mortality, with an incidence reported between . - % of all transfused patients. the most important transfusion related pulmonary complications are transfusion associated circulatory overload (taco), transfusion related acute lung injury (trali) and transfusion associated dyspnea (tad). in this presentation the recent changes in the international definitions will be presented and discussed. furthermore, insights in the different underlying pathophysiologic mechanisms will be highlighted. in the past decades only for trali prevention strategies have successfully been designed and implemented. currently no evidencebased treatment strategy is available for any of these life-threatening syndromes. insight in the pathogenesis of pulmonary complications after transfusion should pave the way for future prevention and treatment studies. the issue of the impact of iron overload / toxicity on the hematopoietic stem transplantation (hct) outcome has been firstly addressed in the field of transfusion dependent thalassemia. today the concept has been extended to other diseases characterized by periods of variable duration of transfusion dependence such as myelodysplastic syndrome (mds) and myeloproliferative diseases. patients requiring regular blood transfusions certainly develop iron overload leading to tissues and organ damage. iron burden before transplant significantly impacts outcome and long-life posttransplant. it is well known that iron overload is deleterious for organs such as liver, heart and endocrine glands and it has been postulated could also increases the risk of infections and severe graft versus host disease early after hct. recent preclinical data has shown how increased production of reactive oxygen species (ros) resulting under iron overload condition, could impair the stem cells clonality capacity, proliferation and maturation. also, microenvironment cells could be affected through this mechanism. for this reason, iron overload is becoming an important issue also in the engraftment period early post-transplant. high baseline ferritin levels before hct have been shown to negatively influence clinical outcome, but nowadays, ferritin is considered a steady and not biologically active form of iron, while free iron forms as non -transferrin bound iron (ntbi) and labile plasma iron (lpi) are considered the main trigger of cell damage more representative of the dynamic tissue damage. the scientific community is moving the iron disease from a "bulky" disease, such as classically in thalassemia (based on quantitative iron parameters as ferritin, red blood cell transfusion number, mri) to a "toxic" disease (based on active and dynamic biological markers as ntbi/lpi). at this time in all the studies published on hct setting, only the correlation between direct or indirect estimates of iron overload (mainly serum ferritin) and outcome parameters has been explored, while the duration of exposure to toxic iron species has not been taken into account. the first study that explored the lpi role in relationship with outcome was published by wermke and colleagues in malignancies. they investigated the predictive value of both stored (mri-derived liver iron content) and non-transferrin-bound-iron, defined as enhanced labile plasma iron (elpi) on post-transplantation outcomes in patients with acute myeloid leukemia or mds. their prospective, observational all-ive study showed that patients who had raised elpi concentration at baseline, also had significantly increased incidence of non-relapse mortality at day ( %) compared with those who had normal elpi at baseline ( %) (p = . ). reinterpreting transplant predictive factors in the light of the current advances in understanding iron homeostasis further supports the concept that the key to successful transplantation is regular and life-long chelation therapy to consistently suppress tissue reactive iron species and prevent tissue damage in the years before hct. in transfusion medicine, the role of donor sex was long considered to be limited to the increased risk of trali observed after transfusions from female donors. this risk has been shown to be limited to female donors with a history of pregnancy and to plasma rich products (i.e. excluding red blood cell products, typically containing < ml plasma). until, in , we found that sex-mismatched red blood cell transfusions were associated with increased recipient mortality. since then, several other studies have confirmed these findings, but some studies also did not find an association. all of these studies relied on the analyses of routinely collected health care data, which was not primarily intended to be used for research. as a result, analyses are complex and often difficult to properly appraise based on published descriptions. therefore, the discussion about possible reasons for these discordant findings has largely focused on the methodological approaches of the different studies. other potential explanations include differences in donor or patient populations, production methods, or storage time of blood products. the different potential explanations are expected to be associated with different underlying biological mechanisms. therefore, further delineating which donor, patient, and product characteristics modify the observed association could provide more insight into the underlying mechanism. in , we observed that only transfusions from female donors with previous pregnancies were associated with increased mortality and only in male recipients under years. this leads us to postulate that pregnancy induced long term changes in the female immune system are transferred during red cell transfusion, with negative consequences for young male recipients. the low amount of plasma present in red cell products further lead us to assume a cellular component, like passenger leukocytes, to be involved. it has been shown that micro-chimerism of passenger leukocytes can persist for decades after transfusion, even of leuko-reduced blood products, suggesting long term immune-modulation could play a role. we hypothesized that passenger leukocytes would die during storage of blood products and the negative effect of ever-pregnant female donors, on the survival of young male red cell recipients, would therefore be attenuated by increased storage time. however, our data seem to indicate the opposite. the risk of death was increased over three-fold for young male recipients of old (> days storage) red cells from ever-pregnant donors, compared to for young male recipients of fresh (< days storage) red cells from ever-pregnant donors ( -year cumulative incidence of death . % versus . %). the negative control group (i.e. young male recipients of red cells from male donors) showed a much weaker association of mortality with storage time (i.e. . % versus . %). these findings seem to falsify our hypothesis that mortality could be caused by passenger leukocytes, establishing long term immune-modulatory effects. another potential mechanism that has been suggested could be the presence of cellfree dna in transfused blood products. this cell-free dna increases during storage. however, more research is needed both to establish if cell-free dna can also be linked to previously pregnant blood donors and by which mechanism it could negatively affect young male transfusion recipients. clinical trials (cts), the gems in clinical research for generating robust evidence in medicine and public health, are costly and complicated undertakings. in resource limited setting like sub-saharan africa (ssa) where the health systems are sub-optimal and where capacity for research is limited, the conducting of cts can be a daunting challenge. the challenges of undertaking cts in rls may be categorized based on the occurrence of the bottleneck(s) in relation to the ethics and regulatory approval process: pre-approval: protocol development: in order to develop a context-specific protocol which is subsequently subjected to an ethics and regulatory approval process, investigators need to review and ensure that the protocol is pragmatic and feasible with respect to implementation. this results into a time-consuming reiterative process of reality-checking the protocol. site selection: in light of the limited research infrastructure, investigators in rls and their developed world partners spend considerable time reviewing and selecting suitable sites for participation in the anticipated protocol for the cts. suitable sites are usually very few and with competing on-going studies. approval: institutional review board (irb) approval: the irb approval process can be quite lengthy ( - months) with considerable unpredictability in the periods between the initial and subsequent irb reviews. national regulatory approval: the requirements by national regulators are unusually innumerable with limited flexibility to accommodate specific cts. post-approval: the key post-approval challenges for cts implementation in rls are attaining appropriate participant enrolment and maintaining high retention rates. specifically, for participant enrollment, the challenge may be unforeseen competing cts targeting the same participant pool or community perspectives that may discourage participants from getting screened for the cts. retention may also be a challenge particularly where participants view enrollment as a chance to access healthcare services may therefore not have any incentive to keep in a study after the initial study visits. in conclusion, cts are complex undertakings wherever they are conducted but are doubly challenging in rls like sub-saharan africa. the bottlenecks at the preapproval, approval and post-approval stages are considerable. nevertheless, it is rewarding to perform ctus in rls given that the data generated therein is highly valued by national regulators and may hasten the registration process for medical products. background: interest in an appropriate and effective whole blood (wb) pathogen reduction technology (prt) is growing, especially in sub-saharan africa where the residual risk of transfusion-transmitted infections (ttis) remains unacceptably high and wb is still frequently used. cerus corporation, manufacturer of the intercept tm blood system, and swiss transfusion src are collaborating on a clinical development program to adapt intercept prt using amustaline (s- ) and glutathione (gsh) for red blood cells (rbcs) into an appropriate prt for wb in resource-limited settings in africa. treatment with amustaline/gsh has been shown to inactivate a broad spectrum of transfusion-transmissible pathogens in rbcs. studies with amustaline/gsh in wb have shown effectiveness against a duck hepatitis b virus (> . log reduction) and plasmodium falciparum (> . log reduction), with future studies planned. a wb prt system with amustaline/gsh also has the potential benefit of minimal electricity requirements. aims: to describe the safety and clinical objectives for a phase clinical trial using the amustaline/gsh prt system for wb in africa, and describe research and development efforts to adapt the intercept prt system for rbcs into a robust and appropriate wb system for settings with high burdens of tti and limited resources. methods: the protocol for a phase clinical trial using pathogen-reduced wb treated with amustaline/gsh in an african country is presented, as are current research and development activities related to the development of a prt system for wb. results: in the planned phase clinical trial in africa, clinically stable patients with anemia who require wb transfusion will be randomized into two study arms at a large medical center in a sub-saharan african country. enrolled patients will receive one unit of non-leucocyte-reduced wb treated with amustaline/gsh, or a unit of untreated control wb or rbcs. the primary safety endpoint will be the incidence of high-imputability transfusion reactions (swissmedic ≥grade ) within the first hours of transfusion. data will also be collected on all adverse events and transfusion reactions (all grades) and the development of treatment-emergent antibodies to pathogen-reduced wb or auto-antibodies within (ae ) days of the study transfusion. clinical efficacy will be characterized by hemoglobin increment hours after transfusion adjusted to hemoglobin dose and body weight. summary/conclusions: a prt system for wb is being developed based on the intercept prt for rbcs that is in advanced development in europe and the united states. intercept-treated rbcs have met efficacy and safety endpoints in phase clinical trials. the amustaline/gsh prt system used to treat intercept rbcs has demonstrated effective inactivation against a broad spectrum of agents that may result in ttis. a phase clinical trial using an adapted prt system for wb in africa is the first step in a clinical development program that includes additional pathogen inactivation efficacy studies and improvements to the wb prt implementation process. together, these developments and evaluations represent progress toward a realistic and appropriate prt for wb in africa and other resource-limited settings. background: in australia, demand for plasma-derived products has increased dramatically, and there is a need to increase plasma collections. first-time donor retention, including the rate at which first-time donors return, is a pressing issue. a quick return is optimal as this increases the overall plasma yield and is associated with long-term retention. however, we lack evidence of effective interventions to encourage first-time donors, particularly those donating plasma, to return and to establish a higher frequency donation routine. working from schultz's ( ) framework, this intervention study was based upon insights from interviews with first-time plasmapheresis donors. participants identified barriers such as time and lack of knowledge about plasmapheresis. facilitators included being able to help more people and to donate more frequently than allowed with whole blood. participants generally favoured donating at a frequency of every weeks. aims: the aim of this study was to test the effectiveness of three intervention conditions compared with the business-as-usual (bau) procedure on the proportion of donors returning to donate plasma and the number of plasma donations. we report on the data from months post-donation. methods: donors were randomly assigned to one of four study conditions. in conditions and , donors received an email one day after their initial donation. in the first condition, donors received the bau 'thankyou' email. donors in the second condition received an alternative email with content derived from the interview study. donors in the remaining conditions received either the bau email (condition ) or the revised email (condition ) coupled with a telephone call. the phone call was scripted to provide additional information about plasma, including how often plasma can be donated, a suggestion to donate every weeks, and a prompt to forward-book appointments. results: the final sample (n = ) comprised women ( %) and men ( %) aged - (mean = ). after two months . % of donors returned to donate plasma at least once. after controlling for gender, age, and blood group, donors in each of the intervention conditions were more likely to return to donate plasma than were donors in the bau condition. the greatest effect was found between donors randomized to condition (revised email + phone call), or = . , ci = . - . , and bau. donors assigned to the two telephone conditions (condition and ) donated plasma at a higher frequency than bau. summary/conclusions: this study tested the effectiveness of interventions designed to encourage first-time plasma donors to return to donate plasma and to establish a routine of donation. early indicators suggest that the evidence-based email and phone call elements are more effective than bau in bringing donors back to donate plasma, and the revised email combined with a phone call had the greatest positive effect on short-term plasma yield. background: healthy individuals with hereditary hemochromatosis (hh defined as hyperferritinemia and homozygous p.c y mutation), but also carriers of other hfe mutations (p.c y/p.h d or homozygous h d) with elevated serum ferritin (sf) are accepted as blood donors, if allowed by local regulations and if eligibility is fulfilled. generally, blood components are released for transfusion at normal sf levels (< ng/ml in females, < ng/ml in males). aims: prospective, two-center, randomized study comparing the efficacy and tolerability of double-erythrocyte apheresis ( rbcaph) and whole blood phlebotomy (wbph) for iron depletion in asymptomatic subjects with hh or hyperferritinemia and other hfe mutations in the setting of routine blood donation. methods: eligibility criteria included age ≥ - years, total blood volume ≥ l, bmi < kg/m , hb ≥ g/l, elevated sf levels and no end organ damage due to iron overload. rbcaph ( ml rbc) were scheduled every days and wbph ( ml) every days until sf was < ng/ml. a complete blood count and sf were measured at baseline, at every visit and at follow up weeks after completion of the study. adverse events were systematically recorded. the treatment effect was tested by poisson regression, with gender, hfe mutation, bmi and baseline sf as covariates. results: subjects ( females; mean age years) were randomized to wbph (n = ; female) or rbcaph (n = ; females). hfe mutations were p.c / p.c y in subjects, p.c y/p.h d in , and p.h d/p.h d in . at baseline, mean hb was g/l (sd . ) and median sf was ng/ml (iqr - ng/ml). procedures (wbph n = , rbcaph n = ) were completed; were interrupted (local hematoma, insufficient flow); ( wbph, rbcaph) were postponed because of low hb and for non medical reasons. there were drop-outs in the wbph arm due to depression and poor compliance, respectively. anemia (hb < g/l in males, < g/l in females) occurred after visits in wbph subjects and after visits in rbcaph subjects. fatigue was reported after phlebotomies and aphereses. only participants ( %) completed the study per protocol. blood components ( rbc concentrates and plasma units) for transfusion were obtained. overall, a median of . wbph (iqr . - . ) was needed to reach sf < ng/ml, corresponding to . times of rbcaph (median . , iqr . - . ) (p = . ). analyzing separately p.c /p.c y and p.c y/p.h d carriers, the relation wbph to rbcaph was . and . , respectively. treatment arm and hfe mutation were the covariates with significant effect on the primary endpoint (p = . and . , respectively). summary/conclusions: rbcaph is more efficient than wbph for iron depletion in healthy subjects with hh or other hfe mutations and moderate hyperferritinemia. intensive treatment schedules, generally recommended for hh, are difficult to keep because of hb drop and compliance. less intensive treatment in asymptomatic individuals with hh and their inclusion in blood donation would avoid negative effects on quality of life and benefit blood collection centers in the long term. background: serum ferritin (sf) measurements in whole blood (wb) donors demonstrated that female sex and intensity of donation are major risk factors for iron deficiency. approximately ml red blood cells (rbc) and - mg iron are lost with wb donation. double unit rbc ( rbc) collections of ml (ca. ml less than the rbc amount of two wb donations) lead to a loss of about mg iron. in switzerland, the maximal allowed donation frequency for male donors is once every months for rbc and once every months for wb donation. aims: to describe and compare the course of hemoglobin (hb) and sf in male subjects donating wb and rbc at our institution. methods: we included wb and rbc donors (n = ) who donated with the maximal allowed donation frequency over months between and , yielding , wb and , rbc donations. we excluded subjects with hyperferritinemia and known hfe mutations. hb limits were g/l for wb and g/l for rbc donation. with rbc apheresis ml rbc were collected. sf was measured on a predonation serum sample; hb was determined from finger prick samples. the donors received no iron substitution. we used generalized estimating equation models for hb and sf trajectories. results: mean age at the first blood donation was (wb) and years ( rbc), respectively. at the first donation, mean hb was g/l (sd ) in wb and g/l (sd ) in rbc donors; mean sf was (sd ) and lg/l (sd ), respectively. on average, hb and sf were higher in rbc donors ( . g/l and lg/l, respectively; p < . ). there were subjects with sf < lg/l in wb and in rbc group, and with sf < lg/l (but > lg/l) and , respectively. in rbc donors, between the first and the last donation, mean hb declined from g/l to g/l (p < . ) and mean sf from lg/l to lg/l (ns). in wb donors, mean hb dropped from g/l to g/l (p < . ) and sf from lg/l to lg/l (p < . ). similar results were found when adjusting for age and season. hb values dropped from baseline until the th donation for wb donors and until the th donation for rbc donors with an upward trend thereafter. in both groups, no hb value below the limits of blood donation and no anemia were observed. sf reached a nadir at the th donation in both wb and rbc donors ( lg/l and lg/l) and increased thereafter in rbc donors. in wb donors, sf followed a parabolic trend that peaked at the th donation, and then declined until the last donation. summary/conclusions: the maximal allowed blood donation frequency for wb and rbc male donors in switzerland is not only protective for the development of anemia, but also for deferral of blood donors because of low hb. this was observed even in subjects with low sf at baseline. background: granulocyte concentrate transfusion is a potentially lifesaving option for patients without functional neutrophils. however, recent studies have failed to demonstrate the anticipated clinical effectiveness of this procedure. granulocyte concentrates are manufactured using sedimentation agents to separate granulocytes from red blood cells and enhance granulocyte collection efficiency. high-molecularweight hydroxyethyl starch (hes) is most commonly used for this. however, authorities recently restricted the use of hes due to its unfavorable risk-benefit-profile. modified fluid gelatin (mfg) is an already used alternative sedimentation agent. as the granulocyte product contains these substances, any impact of the sedimentation agent on granulocyte function may affect the clinical effectiveness of granulocyte transfusion. aims: we tested the hypothesis that mfg is not inferior to hes in terms of the functionality and viability of granulocytes. methods: granulocytes from ten healthy donors were isolated, aliquoted and incubated in parallel for hours with either % (control), . %, % or % mfg (gelafundin %, b. braun melsungen ag) or hes (hespan %/ / . , b. braun medical inc.), respectively, and granulocyte migration, chemotaxis, reactive oxygen species (ros) production, neutrophil extracellular trap formation (netosis), antigen expression of cd b, cd l and cd b, and viability were subsequently investigated in vitro. testing was performed using live cell imaging of the cells embedded into a collagen i matrix for parallel testing of migration, ros production and netosis. in addition, flow cytometric (facs) analysis was utilized for surface marker expression, viability and respiratory burst measurement. results: granulocyte migration decreased in a dose-dependent manner in response to hes and mfg. relative to the controls, all three concentrations of hes lowered migration distances (p < . respectively), whereas only the higher concentrations ( % and %) of mfg showed lower relative migration distances (p < . respectively). track straightness was reduced with both sedimentation agents at % and % to the same extent (p < . respectively). hes resulted in lower cd b expression (p = . ) and higher cd l expression (p = . ) compared to the controls, whereas the differences for cd b did not reach statistical significance. mfg did not affect the expression of any investigated surface antigen mediating endothelial adhesion and transmigration in comparison to the controls. no significant differences in the timing of ros production or netosis, or in neutrophil viability or respiratory burst were observed. summary/conclusions: these results indicate that mfg is not inferior to hes in terms of granulocyte phenotype and function in vitro when used at equal concentrations, and that potential impairment of granulocyte function can occur with hes. background: plateletpheresis donation leads to a well-known transient decrease of donor's platelets. the question of long-term effects raised with the development of regular donations by some donors in order to satisfy a growing demand. a seminal work (lazarus, transfusion, ) stated that there is a sustained thrombopenia in frequent plateletpheresis donors, correlated with the total number of donations. aims: french regulation authorizes up to plateletpheresis donations per year, with a minimum weeks interval between them. we tried to evaluate the risk of sustained thrombopenia under these conditions. methods: we retrieved all plateletpheresis donations occurring between / / and / / from the french civilian blood donors' base and then selected a cohort of donors with at least donations during that period. in order to minimize measurement errors, platelet counts analysed were means of three consecutive donations, i.e. measures for each donor. results: the cohort includes , donors ( women and , men). mean platelet counts fluctuate between . and . platelets/ml. analysis of variance does not show any statistically significant difference (f = . ), even taking donor's sex or age in consideration. there is no difference if we consider the total duration of the donations, either. donors with the lowest first counts show a significant rise in subsequent measures and donors with the highest counts show a decrease trend, exhibiting a classical regression toward the mean. summary/conclusions: plateletpheresis french regulation does not seem to be at risk of sustained donor thrombopenia. this conclusion is in agreement with recent literature data. the primary biological role of the human leukocyte antigen (hla) system is the regulation of the immune response to foreign antigens. because of this role, hla genes and molecules have an important role in transplantation, etiology of many autoimmune, non-autoimmune and infection diseases, but also in transfusion medicine. an increasing probability of an hla non-compatible blood products, tissues or organs exists due to the extremely high polymorphism of hla genes, with more than , described alleles to date, and their different frequency distribution in various worldwide populations. the hla system, originally discovered as a result of a transfusion reaction in the s, can cause detrimental immune reactions in transfusion therapy. hla antibodies present in the patient are responsible for some of these reactions, while in other cases hla antibodies or hla reactive cells present in the transfused product are accountable for the immunoreactivity. hla antibodies form as a result of exposure to foreign hla antigens during pregnancy, transplantations and blood transfusions and can cause platelet immune refractoriness, febrile transfusion reaction, transfusion-related acute lung injury, and transfusion associated graft versus host disease. in order to avoid or reduce the development of these transfusion-related events, hla antibody negative or compatible products should be used. almost all existing methods presently used for molecular typing of hla polymorphisms are based on polymerase chain reaction, but with different resolution levels (low resolution -two digits or high resolution -four digits). in addition to providing a more precise detection of polymorphisms at hla classical loci (e.g. hla-a, -b, -c, -drb , -dqb ), molecular methods can also determine polymorphisms at hla loci which previously could not be typed by serology (e.g. hla-drb , -drb , -drb , -dqa , -dpa ). the most commonly used method for the detection of hla antibodies was until recently complement-dependent cytotoxicity (cdc) technique, but it is increasingly being replaced by a more sensitive, solid phase based method (luminex technology). in conclusion, an accurate and precise determination of both hla gene polymorphism and hla antibodies presence is essential for the safe and efficient administration of transfusion products. background: in only a minority of pregnancies complicated with anti-hpa a antibodies serious fetal/neonatal disease develops. the difficulty in predicting which mothers should be treated with ivig hampers implementation of fnait screening. we found that fc-core fucosylation and galactosylation are highly variable in anti-hpa a igg, and that these glycan features strongly affect binding to fccriiia receptor. the level of fc-core fucosylation of anti-hpa a alloantibodies was found to correlate with platelet count and outcome of the newborn, suggesting that antibodyspecific fucosylation might serve as a biomarker in fnait screening. however, at present the fc-glycosylation pattern can only be determined by complicated methods involving purification of the antigen-specific igg, and analyzing trypticly released -igg-derived-glycopeptides by tandem liquid chromatography-mass-spectrometry (ms) techniques. these methods, although powerful, are not yet suited for high throughput clinical screening. aims: our aim was to provide a simplified method to quantify the biological activity of anti-hpa- a antibodies, and possibly other alloantibodies against blood cells. methods: here we explored if cellular surface plasmon resonance (spr) imaging can replace ms, resulting in less complicated handling of patient sera and donorantigen-bearing cells. the strength of the binding of platelets to fccr on spr sensor was monitored under flow. the spr sensor was equipped with both wt fccriiia (sensitive to fc-glycosylation status) and mutant fccriiia-n a (insensitive to fcglycosylation status). in addition, the biosensor was prepared with anti-platelet cd (c ) and anti-igg to calibrate the number of injected platelet as well as to quantify igg-opsonization. the quality of the anti-hpa a glycosylation was monitored as the ratio of the binding of opsonized platelets to the wt and the mutant n a-fccriiia. platelets opsonized with recombinant glycoengineered anti-platelet antibodies with different levels of fc-fucosylation were used as standards. for validation, plasma samples with anti-hpa a antibodies, already analyzed by mass spectrometry and with known clinical outcome were tested (sonneveld, bjh, ) . results: we found that the ratio between the binding to the wt fccriiia and to the mutant n a-fccriiia correlated with the level of fucosylation of the hpa a antibodies, as measured by mass-spectrometry (r = À . ; p < . ). overall, a similar predictive value for disease severity was obtained as we previously reported for this retrospective cohort. in addition, quantitative information on antibody concentration can also be extracted using the fccriiia-n a receptor as sensor on the chip, while anti-igg gave aspecific signals, presumably because it recognized cytophilic platelet-fccriia-bound antibodies as well. summary/conclusions: in conclusion, the combined use of wt and mutant fccriiia in a label free spr assay provides both quantitative and qualitative information of platelet bound anti-hpa a antibodies, which circumvents the need for purification of specific antibodies and laborious mass spectrometric analysis. this approach might be generally applicable to determine the biological activity of cell bound antibodies not only for anti-hpa a in fnait, but also for anti-rhd alloantibodies in hdfn or anti-platelet antibodies in itp. background: immunization against the human platelet hpa- a alloantigen is the most common cause of severe fetal and neonatal alloimmune thrombocytopenia (fnait) in otherwise healthy term newborns. the screening for hpa- a antigen in pregnant women is an important tool for identification of pregnant women at risk of having a fetus/neonate with fnait. any targeted intervention depends on efficient screening methods as well as sensitive and specific methods for detection of anti-hpa- a. within the framework of the polish-norwegian project (prevfnait) we have performed hpa- a screening program in poland. aims: our aim was to assess the frequency anti-hpa- a antibody detection and the clinical outcome of newborns identified through the study. women who joined the program due to the fnait in the previous child or in the current newborn are not analyzed in this study. methods: hpa- a screening of pregnant women in - gestational weeks was performed by facs phenotyping or rq-pcr genotyping at ihtm in warsaw. hpa- a negative/hpa- b/ b women were tested for hla drb * : and for anti-hpa- a antibodies by maipa (followed up at week - , , , - and weeks after delivery). if anti-hpa- a were detected, quantitative maipa was performed. all hpa- a negative women were contacted for information concerning the newborn. if the baby had thrombocytopenia and anti-hpa- a were not detected by maipa, the look back samples were tested retrospectively by paklx test (immucor). results: hpa- a negative women were identified ( . %). anti-hpa- a was antibodies were detected by maipa in women (two delivered tweens). in addition, anti-hpa- a antibodies were later detected by paklx in further women who delivered baby with severe thrombocytopenia and/or ich. total number of immunized mothers was ( . %). they delivered babies; were boys. three women were treated by ivig: two by and injections since th and th gw respectively. the anti-hpa- a concentration in the st one was . ; . ; . iu/ml in , , gw respectively and in the nd < . iu/ml in all examined samples. the decision on treatment was based on the low plt count~ g/l in the fetus in cordocentesis. their newborns (one delivered tweens) were healthy. the rd treated woman entered the program in gw (anti-hpa- a concentration was high . iu/ml). she obtained one injection of ivig. her baby was born with mild thrombocytopenia with no ich. severe fnait occurred in / newborns: in with anti-hpa- a detected in paklx only and in with antibody concentration in maipa - st : . / . / . at / / th gw respectively; nd : . / . at / th gw respectively. ich was observed in all of them; plt count was < x in four, / in one. summary/conclusions: / the severe thrombocytopenia due to anti-hpa- a alloimmunisation in our prospective study occurred in / pregnancies / the paklx could improve anti-hpa detection in the screening program and should be considered as an additional diagnostic test, if maipa result is negative / the hpa- a alloimmunisation frequency is higher in pregnancies with male than female fetus. background: foeto-maternal platelet alloimmunization (fmpai) is mainly characterized by foetal and / or neonatal thrombocytopenia (fnait), sometimes revealed by intracranial hemorrhage (ich) or even by foetal death in utero (fdiu). the experience of the pnil milwaukee (usa) reported in that the diagnosis of alloimmunization was carried in only % of neonatal thrombocytopenia cases with a clinical symptomatology highly suggestive of an alloimmune etiology. aims: the aim of this two-year study was i) to determine the frequency of platelet incompatibilities in fnait, ich and fdiu and ii) to evaluate the frequency of detectable platelet alloantibodies (alloab) and their specificity in cases of incompatibility. methods: platelet genotyping was performed by hpa beadchip genotyping kit (bioarray solutions, immucor, warren, nj). serology investigation was carried out by different methods: complete maipa kit (apdia bvba, turnhout, belgium), pack lxtm assay (immucor gti diagnostics, waukesha, wi) and « in house » maipa. all and data were collected using the laboratory information management system. results: patient files were analyzed. no incompatibility is demonstrated in hpa- to - , - and - systems in . % (n = ). hpa- and / or and / or incompatibilities were found in cases ( . %), hpa- and / or in cases ( %). platelet alloimmunization was globally confirmed in only . % of the cases. platelet alloabs were identified regardless of clinical manifestations: anti-hpa- a ( . %), anti-hpa- b ( . %), anti-cd ( . %), anti-hpa- a and anti-hpa- b ( . % respectively) and anti-hpa- b and anti-cd ( . % respectively). alloabs were found in the context of neonatal thrombocytopenia, in ich and in fdiu, and in a follow-up of pregnancy. even if no anti-hpa- alloab could be identified, the incompatibility in this system was highly associated with fnait, ich and fdiu (n = , n = and n = on cases). summary/conclusions: this study strongly confirmed the known immunogenicity of some hpa systems and highlighted overall the severity of hpa- and hpa- incompatibilities. the definite diagnosis of fmpai is difficult to make due to the present technical difficulties in the detection of antibodies against the hpa- and hpa- systems. however, our results suggest that special attention should be paid to the management of pregnancies with these incompatibilities due to the frequency of severe foetal/neonatal adverse events. background: fetal and neonatal alloimmune thrombocytopenia (fnait) is a potentially life threatening disease caused by maternal alloantibody formation against fetal human platelet antigens (hpas), of which anti-hpa- a is accountable for the fast majority of the cases. population-based screening for fnait has been topic of debate for over decades. logistically as well as financially, the major challenge of such a screening is the typing of pregnant women to recognize the % hpa- a negative women. at present, hpa- a typing is mostly done by genotyping. for costeffective implementation of anti-hpa- a screening there is need for a high-throughput, quick and low-cost phenotyping assay. aims: the aim was to develop a high-throughput, quick and low-cost phenotyping assay in order to identify hpa- a negative pregnant women. methods: an automated sandwich elisa was developed to perform hpa- a phenotyping using a murine monoclonal anti-gpiiia as coating antibody and horseradishperoxidase-conjugated recombinant igg anti-hpa- a as detecting antibody. to ensure the applicability for high-throughput testing in a potential screening setting, ll of the uppermost plasma of - days-old stored edta anticoagulated blood tubes was used, without first swirling or spinning them. in two phases, samples of pregnant women were tested and compared to an allelic discrimination polymerase chain reaction assay as golden standard. in the first phase, samples from unselected consecutive pregnant women were tested. the second phase was part of a prospective screening study in pregnancy and confirmatory genotyping was restricted to samples with an arbitrary set od < . in the hpa- a elisa. the developed elisa was optimized to require no additional handling (swirling or spinning) of stored tubes. during phase i, consecutive samples were tested. in phase ii, the hpa- a elisa was performed in another , consecutive samples, with confirmatory q-pcr in , . the two phases combined, samples from in total , hpa- a negative and hpa- a positive pregnant women were genotyped. the assay reached a % sensitivity with a cut-off od between . and . , leading to a specificity of . %. summary/conclusions: a quick, low-cost and reliable assay for hpa- a phenotyping was developed that can be used in a population-based screening setting to select samples that has to be tested for the presence of anti-hpa a antibodies. because plasma from non-mixed or spinned tubes of three to six day-old samples can be used, this assay is applicable to settings with suboptimal conditions. background: cytomegalovirus (cmv) sero-prevalence in ireland is lower than that which is reported in many other european countries. a study of pregnant women in found that . % of irish women were cmv seropositive in comparison to % from western europe and % eastern europe and % from africa. an internal study carried out by the irish blood transfusion service (ibts) in indicated the rate of cmv seropositivity in irish blood donors was . %. therefore a significant proportion of the irish donor and recipient population are susceptible to primary cmv. this is of particular concern for patients for certain at-risk groups such as very-low birthweight cmv seronegative neonates, cmv seronegative patients undergoing transplantation and other cmv seronegative immunocompromised patients. this results in a demand for the provision of cmv sero-negative blood components. in the ibts evaluated the abbott alinity s cmv igg assay as a replacement for the cmv mastazyme eia (total ab eia). aims: to assess the performance of the abbott alinity s cmv igg screening assay in comparison to the cmv mastazyme eia (total ab eia). methods: diagnostic sensitivity was determined by testing confirmed cmv igg positive donors from an external laboratory. sensitivity was assessed using three seroconversion panels (n = ). analytical sensitivity was calculated using linear regression analysis of the who first international standard for anti-cmv igg. diagnostic specificity was determined by testing donors. further evaluation of discordant results was carried out using the architect anti-cmv igg and igm assays and vidas anti-cmv igg and igm assays. results: the diagnostic sensitivity of the alinity s anti-cmv igg assay was determined to be %. the seroconversion sensitivity reported out of samples reactive. the analytical sensitivity of the alinity s cmv igg assay was determined to be . iu/ml. the validation reported discordant results from donor samples tested with both the alinity s cmv igg assay and the current mastazyme total assay. discordant results were observed (alinity s anti-cmv igg positive/mastazyme total negative). further testing of these samples classified discordant results as positive, as negative and as indeterminate. discordant results were observed (alinity s anti-cmv igg negative/mastazyme total positive). further testing classified these samples as negative. overall the diagnostic specificity was determined to be . %. summary/conclusions: both the seroconversion and analytical sensitivities are comparable between the alinity s cmv igg assay, the cmv mastazyme total ab assay, the architect cmv igg assay and the vidas igg assay. the slight variations can be attributed to the individual assay cut-off definitions, which can vary greatly between cmv assays. it must be noted that the determination of the diagnostic specificity ( . %) does not include indeterminate discordant results. further testing will be carried out to try to characterize all discordant samples in collaboration with abbott. this evaluation did not identify any donors with isolated confirmed cmv igm antibodies in a pool of donors. based on this evaluation the abbott alinity s cmv igg assay is a suitable replacement to the mastazyme total ab assay for blood donor screening. background: africa has a unique set of challenges regarding safe blood transfusion. two of the largest contributing factors are: ) the most common disease states in sub-saharan africa (ssa) require large amounts of blood as lifesaving interventions e.g. malaria, ) the highest burden of infectious diseases transmissible through transfusion (tapko, toure, & sambo, ) is found in ssa. this has often led to the binary donor base that exists in ssa, consisting of voluntary non-remunerated blood donors (vnbd) and family or replacement donors (frd) as transfusion centres are unable to supply the demand when relying only on vnbd. voluntary non-remunerated donors are the safest blood donors as they have no incentive (other than altruistic motives) and are not under social pressure to donate, both factors that may induce individuals knowing or suspecting themselves to be infected with a blood-borne agent to donate blood. nucleic acid testing (nat) in conjunction with serological testing is the gold standard for testing, however, the vast distances and high temperatures of africa makes transport of traditional plasma samples a logistical challenge. many publications evaluating the stability, suitability, and ease of use of dried blood spots (dbs) for nat have been published. generally, results have been shown to be comparable to traditional plasma samples. dbs is being used successfully in the early infant diagnosis (eid) programs for hiv by means of pcr testing, especially in africa. aims: . to demonstrate that dbs and/or dried plasma spot (dps) testing is suitable for blood donor screening and can make nat testing more widely available in africa . to determine the diagnostic sensitivity and specificity of testing dps and dbs samples, in comparison to testing of plasma samples. methods: negative new donor samples and confirmed positive donor samples, as defined by routine blood safety screening done at western cape blood service, were screened using a dried blood spot kit. after routine testing was completed, one dbs sample and one dps sample for each blood donor were prepared and analysed with the ultrio elite assay on the panther analyser. summary/conclusions: dbs/dps can be used as a sample for screening blood donors as the invalid rate was . %, and only found on dbs samples. logistically dbs/dps is well suited for the resource-poor countries as samples are: -easy to obtain (fingerpick samples could be used.) -transport is simplified as samples will not leak or haemolyse due to high temperatures. -samples can be stored at room temperature dbs/dps demonstrated acceptable specificity. the ultrio elite performed well with regards to hiv and hcv sensitivity. sensitivity with regard to hbv was not as high but this could be due to very low and erratic viral loads. background: sanquin blood supply is responsible for the blood transfusion services in the netherlands. at the national screening laboratory sanquin (nss) annually more than . blood and plasma donations are tested, on average . samples per day. for more than years, infection serology testing was performed using the prism (abbott diagnostics), but since mid of july , serological testing for the hbsag, hiv ag/ab, anti-hcv and anti-hbc is done with abbott's alinity s system. aims: to compare the numbers of initially and repeatedly reactive results of whole blood and plasma donation samples and the rate of non-specific results leading to deferral of donations and donors for prism and alinity s assays using data from months before and months after implementation of the alinity s systems at nss. methods: initial and repeat reactive rate of the assays run by either prism (hbsag, hiv o plus, hcv) or alinity s (hbsag, hiv ag/ab combo, anti-hcv,) were calculated for january to june (prism) and august to december (alinity s). due to the lack of a true confirmatory method for anti-hbc, we only compared the rate of repeatedly reactive results for prism hbc and alinity s anti-hbc. results: the rate of repeat reactive results for prism (p) and alinity s (a) assays were as follows: ) hbsag p . % ( / . ) versus a . % ( / . ); ) hiv p . % ( / . ) versus a . % ( / . ); ) anti-hcv p . % ( / . ) versus a . % ( / . ). the rate of anti-hbc reactive samples was not significantly different between prism ( . %) and alinity s ( . %). over the study period, the rate of initially reactive samples for the three main screening assays (hbsag, hiv, hcv) was also comparable between alinity s ( . %) and prism assays ( . %), mainly attributable to a rather high number of initially reactive alinity s hiv ag/ab results. this was due to initial issues with blood collection tubes that were resolved. as a result in december, the rate of initially reactive samples decreased to . %, which was significantly lower than for the three prism assays ( . %). summary/conclusions: the introduction of the alinity s assays lead to a decrease of the average repeat reactive test results (hbsag, hiv, hcv) by . % as compared to the prism, mainly due to a lower false reactive rate of the alinity s anti-hcv assay. this will be further investigated for first time and multiple time donors. with the implementation of the alinity s at sanquin we aimed to improve not only the operational efficiency but also to further minimize unjustified disapproval of donors. these first data show that the low initial and repeat reactive rates of the alinity s assays indeed have a positive impact on unnecessary deferrals of donations and donors. background: in blood banks, testing all blood donations for markers of infectious diseases plays an important role in maintaining the safety of blood transfusions. mandatory serological testing in switzerland is performed for anti-hcv, hiv ag/ab, hbsag and syphilis. highly specific and sensitive tests with corresponding automation are essential for this purpose. aims: a comparative study was carried out to evaluate the usability of the newly launched alinity s system (abbott) and the specificity of the infectious disease parameters hbsag, anti-hcv, hiv combo and syphilis (abbott) with the currently used elisa methods on the quadriga befree system (all diasorin, formerly siemens healthcare diagnostics). methods: the study took place at the interregional blood transfusion service in berne, switzerland. the specificity of the parameters was studied on , blood donor sera from both first time and repeat donors. the samples were tested first on the quadriga be free system with enzygnost hbsag . , enzygnost anti-hcv . , and enzygnost hiv integral assays and on the pk with the newbio-pk tpha assay (newmarket biomedical). all samples were retested on the same day with hbsag, anti-hcv, hiv combo and syphilis on the alinity s. initial reactive samples were repeated in duplicate. discriminatory tests were carried out for repeatedly reactive samples using alternative screening tests and neutralisation (for hbsag) on an abbott architect i system and immunoblots (hiv-, hcv-, syphilis-inno-lia, fujirebio). for all samples, results from our routine individual donation nucleic acid testing (hcv, hiv, hbv, roche cobas system) were available. results: based on the results from testing , blood donations, the observed specificities of alinity s assays (a) and enzygnost assays ( summary/conclusions: the alinity s system was easy to use by the operators after a very short introductory training and provides good operational efficiency such as high throughput even when selective testing for samples is needed. the observed specificity of abbott alinity s versus siemens enzygnost assays is comparable in a blood donor screening setting. unfortunately, we were not able to analyse statistically the specificity data due to the insufficient number of donor samples tested in parallel. it is worth mentioning that around % of the samples included in the study derived from repeat donors who had been previously tested with the enzygnost assays but were "first time donors" for the alinity s assays. all four assays from both systems exhibit a very good specificity and are highly suitable and practicable for routine blood donor screening. background: effective screening for transfusion-transmissible infections is essential to ensure safe blood transfusions. the world health organization recommends mandatory serological testing of blood donations for human immunodeficiency virus (hiv), hepatitis b (hbv)/c (hcv), and syphilis. due to increasing demands on clinical laboratories, there is a need for reliable and accurate automated blood screening tests. the fully automated cobas e analyser can be used with elecsys â infectious disease parameters to screen donor blood samples. aims: to compare the performance of elecsys â infectious disease parameters on the cobas e analyser (roche diagnostics) with other commercially available assays for routine first-time blood donor screening. methods: we provide results from etablissement franc ßais du sang (montpellier), a blood bank which participated in a large, multicentre study of the cobas e analyser. the following infectious disease marker assays were compared: hiv, elecsys â hiv duo versus prism hiv o plus; hcv, elecsys â anti-hcv ii versus prism hcv; hbv surface antigen (hbsag), elecsys â hbsag ii versus prism hbsag; hbv core antigen antibodies (anti-hbc), elecsys â anti-hbc ii versus prism hbcore; syphilis, elecsys â syphilis versus newbio pk tpha assay. specificity was tested using residual fresh serum samples from unselected first-time blood donors, and calculated according to assay package inserts and site-specific cutoffs. samples were tested using comparator assays, then retested the same day using elecsys â assays. initially reactive samples were repeated in duplicate; confirmatory tests were conducted on repeatedly reactive samples. confirmatory tests: hiv, nucleic acid testing (nat), architect hiv ag/ab and inno-lia â hiv i/ii score assays; hcv, nat, archi-tect hcv and inno-lia â hcv score assays; hbsag, nat, architect hbsag and elecsys â /prism hbsag confirmatory assays; anti-hbc, nat, hbsag, anti-hbs, and architect anti-hbc assays; syphilis, architect syphilis tp and inno-lia â syphilis score assays. sensitivity was tested using preselected, anonymised, positive, citrate-phosphate-dextrose-plasma samples (plasmatec laboratory products) and compared with archived data for comparator assays. sensitivity was calculated according to the final nat result. results: across all infectious disease markers, specificity to detect repeatedly reactive samples using elecsys â versus comparator assays was similar ( . - . % versus . - . %; n ≥ ). in specificity analyses, there were discrepant results for hiv testing, for hcv, two for hbsag, eight for anti-hbc, and five for syphilis. sensitivity of the elecsys â hiv duo assay ( . %; % ci . - . ) was higher than the prism hiv o plus assay ( . %; % ci . - . ), but the difference was not statistically significant. sensitivities of elecsys â and comparator assays were the same for hcv ( . %; % ci . - . ), hbsag ( . %; % ci . - . ), anti-hbc ( . %; % ci . - . ), and syphilis ( . %; % ci . - . ); three hcv and six anti-hbc samples were classified negative/ indeterminate and excluded from the analyses. in sensitivity analyses, there were two discrepant results for hiv testing, three for hcv, and five for anti-hbc. summary/conclusions: elecsys â infectious disease parameters on the cobas e analyser demonstrate high specificity/sensitivity for screening first-time blood donor samples, with similar clinical performance to other commercially available assays. background: individual plasma and serum specimens from whole blood or plasmapheresis donors are tested for absence of infectious agents by serological assays prior to use for transfusion or production of blood derived therapeutics. the department of plasma analytics (pa), takeda (austria), and haema ag, grifols (germany), both labs with high throughput and a high level of automation, were seeking for alternatives to replace their current serological test systems (abbott prism next). aims: to allow a direct comparison of the two final candidate analyzers alinity s (abbott) and cobas e (roche diagnostics gmbh), a side by side evaluation was carried out by the pa and haema with support from abbott and roche (provision of instruments and reagents). the aim was to compare assay specificities as well as handling and performance of the instruments. the outcome should be used to better understand potential specificity differences and practical handling aspects (throughput, etc.) of a next generation serological analyzer. methods: the two candidate instruments were installed in the pa. from march to june , close to , aliquots from routine preselected repeat donors, provided by haema, were run on both study instruments in parallel. plasma samples were tested for hbs antigen (ag), hcv antibody (ab), hiv ag/ab, and partially for syphilis ab. serum samples were additionally tested on hbc ab. samples with repeat reactive results ("rr", two reactive results out of three tests) not confirmed by confirmatory tests were counted as false reactive. the necessary sample size was calculated based on a one-sided comparison of proportions with the aim to detect potential specificity differences (a = %) in the size of those specified by the manufacturers' instructions. two different lots were tested for the three main assays. results: out of , plasma and , serum samples, test results representing individual donations were found rr on one or both instruments. two samples were confirmed positive ( hbsag, hcv), two others were indeterminate. the sample containing low level antibodies against hcv was pcr negative and only detected by the roche system. the percentage of false reactive results for the five assays on the two systems were (alinity s/e ): hbs ag: . / . % in a total of / samples tested; hcv ab: . / . % in / , p < %; hiv ag/ab: . / . % in / , p < %; syphilis ab: . / . % in / ; hbc: / % in / . no significant difference was found between the calculated specificities in our study and the manufacturers' data. a potential influence of sample matrix and kit lots was assessed. a trend towards more false reactive results in serum vs plasma was found for nearly all assays. no clear-cut statistical difference was seen between lots. summary/conclusions: the study results are in line with the manufacturers' specificity data, showing that the alinity s hcv ab and hiv ag/ab assay show a slightly higher specificity in a population of plasma and serum samples from repeat donors prescreened by prism. a possible influence on the test specificity by the sample matrix was detected but needs further investigation. the possibility to edit complex genomes in a targeted fashion has not only revolutionized basic research but biotechnological and therapeutic applications as well. with the rapid development of genome editing tools, in particular zinc-finger nucleases (zfns), transcription activator-like effector nucleases (talens), and the crispr-cas system, a wide range of therapeutic options have beenand will bedeveloped at an unprecedented speed. therapeutic genome editing in hematopoietic cells enable new interventions in the blood and immune system, including novel approaches to treat immunological disorders, infectious diseases, and cancer. we have developed gmp-compliant protocols to manufacture gene edited cd + hematopoietic stem and precursor cells (hspcs) as well as chimeric antigen receptor (car) t cells, with the final goal to provide novel cell therapies for patients suffering from primary immunodeficiencies, chronic infection with human immunodeficiency virus type (hiv- ), and some tumor entities. despite great success in improving their specificity, engineered designer nucleases can induce genotoxic side effects by introducing mutations or chromosomal aberrations. we have established novel genome-wide assays that enable us to detect chromosomal aberrations induced not only by off-target activity but also by on-target activity, such as micro-aberrations and translocations, with unparalleled sensitivity. in toto, our developed protocols allow us to achieve genome editing in hematopoietic cells with high efficiency and to assess the genotoxic risk associated with the expression of crispr-cas nucleases and talens in clinically relevant human cells, so forming the basis for planned phase i/ii clinical studies. adoptive t cell therapy (act) has proven a potent means to treat blood-borne tumors and solid tumors. adoptive cell therapies include t cells that are genetically engineered with tumor specific t cell receptors (tcrs), or with chimeric antigen receptors (cars). in addition, tumor infiltrating cells (tils) can be isolated from tumor lesions, which are then expanded and reprogrammed in vitro prior to transfusion into the patient. the anti-tumoral efficacy of act products depends on several parameters, including the capacity of cd + t cells to produce cytokines, chemokines and granzymes, a feature that is critical for effective anti-tumoral responses. here i will discuss our efforts to develop and improve act products for future clinical use. i will present pre-clinical work on developing til therapy for non-small cell lung cancers. in addition, i will show that human cd + t cells can be divided into different subsets, and that only one of those subsets is highly cytotoxic. this finding may help improve the quality of genetically engineered t cell products, like tcr and car t cell products. background: the baltic states -estonia, latvia and lithuania have a lot in common. we are located side by side, share the baltic sea as a gate to the west, and more importantly, a common history. we were members of the ussr and suffered years of soviet occupation. we held hands in a km long human . . .chain" across the three states to express our mutual support, and later on, even joined the european union on the very same day -june st , . the three differ a bit in size, population and more in the languages spoken in each one, but that does not explain why the path towards voluntary unpaid donation varies as it does. aim: the aim is to describe the journey towards voluntary non-remunerated blood donation in the baltic states after regaining independence from the soviet union. methods: the information was collected from published and unpublished memories, annual reports and written interviews with latvian and lithuanian colleagues. results: in soviet times, all orders came from moscow and quality control was conducted from the capital city of latvia, riga. donors were mostly paid and given an extra vacation day. big factories were the best places to collect blood and people were queuing to donate. in , the soviet union fell apart and the baltic states suddenly got the freedom and responsibility to decide. in estonia the first edition of "guidelines for the preparation, use and quality assurance of blood components" was taken as guidance in . a lot of advice came from finnish colleagues. in , it was decided to move towards non-paid voluntary donations. the process took years. the first couple of years were economically difficult for the reborn state, as money had less value than food. instead of cash, donors were given rapeseed oil, sugar and pasta, for example. as the situation improved, food items were replaced by small symbolic gifts that carry sentimental value. it has been this way for more than years by now. in lithuania, the process started later, the first program for developing a framework for voluntary non-remunerated donations being carried out in - . it resulted in % of the donations being unpaid. the second program initiated in is still ongoing, aiming towards % non-remunerated donations by . by the end of , they had reached . %. in the beginning, the main obstacle was a private blood center creating unfair market conditions. in latvia, monetary compensation for blood donations still exists, but the younger generation has been encouraged to donate blood for free and some results can already be seen. summary/conclusions: a common starting point does not guarantee the same results, at least not at the exact same time. examining the circumstances leading to the different outcomes could benefit countries yet to start moving towards non-remunerated donations as well as those considering the opposite. haemoglobin (hb) was as expected significantly different between women and men (meanaesem: . ae . vs . ae . g/dl; p < . ). percentage of females with low hb < . g/dl were . %, . %, . %, . % and . %, percentage of males with hb < . g/dl were . %, . %, . %, . % and . % for the age groups - respectively. ferritin values were higher in males compared to females (median; th - th %>tile: ; - vs ; - lg/l; p < . ) and in older age groups compared to younger age groups (median; range in age groups - in females: ; - , ; - , ; - , ; - , ; - and in males: ; - , ; - , ; - , ; - , ; - respectively) . percentage of females with ferritin ≤ lg/l were . %, . %, . %, . % and . %, while percentage of males with ferritin ≤ lg/l were . %, . %, . %, . % and . % for the age groups - respectively. white blood cell counts (wbc) were slightly higher in females compared to males (meanaesem: . ae . vs . ae . ; p < . ). percentage of females with wbc > x /l were . %, . %, . %, . % and . %, while percentage of males with wbc > x /l were . %, . %, . %, . % and . % for the age groups - respectively. none had wbc < x /l. platelet counts (plt) were higher in females compared to males (meanaesem: ae . vs ae . ; p < . ).percentage of females with plt < x /l were . %, . %, . %, . % and . %, while percentage of males with plt < x /l were . %, . %, . %, . % and . % for the age groups - respectively. among the low plt counts most were caused by edta-dependent pseudothrombocytopenia. extreme deviations from normality were seldom and referred to gps for further investigations. summary/conclusions: first time donors are young with % younger than years of age and the female/male ratio was / . of the first time donors with data on ferritin available, % had low ferritin (≤ lg/l). the typical male first time donors neither had low hb nor low ferritin, even with a significantly lower ferritin in younger donors. in female first time donors the prevalence of low hb ( %< . g/dl) and low iron stores ( %≤ lg/l) is high. in all, while all first time donors are highly appreciated, campaigns could target the male population to even out the gender imbalance. blood centers must be aware of the higher prevalence of low iron stores in the youngest donors. background: the aim of assessing suitability of prospective blood donors is protection of their health and the safety of transfused patients. selection process is not always effective in obtaining all relevant information from blood donors in a timely manner. for several reasons, some risks remain undetected or they are disclosed at a future donation(s). therefore, recording and management of post-donation information (pdi) are of great importance for improvement of transfusion safety, donor counselling and education as well as overall improvement of the selection process. aims: the aim of the study was to present results of pdi management at croatian institute of transfusion medicine (citm) and the effect of education activities on their trends. methods: we have analyzed reports on pdi recorded in two-year period ( - ), according to the types of information obtained, age and sex of blood donors, total number of their donations preceding pdi, and the time of receiving the information. the effect of an information leaflet on pdi launched in november was assessed by comparing results in two study years. results: a total of pdi were recorded: in ( / donations) and in ( / donations) with the following distribution: nonsexual risk as tattoo and piercing ( . %), surgical procedures ( . %), travel history ( . %), infections/ contact ( . %), other medical reasons ( . %), endoscopy/invasive diagnostic procedures ( . %), malignancy ( . %), autoimmune diseases ( . %) and sexual risks ( . %). majority ( . %) were late pdi, revealed on the future donation(s): . % on the first next donation, . % on the second and . % after more than subsequent donations. the mean age of blood donors associated with pdi was ae years (median years), while the mean age of all donors in / was years (median years). of all pdi, . % were related to male donors ( % in total pool of citm donors). using chi-square test there were no significant difference between female and male donors in total pdi frequency and in their distribution to early and late pdi (p > . ). the median number of all donations preceding pdi was for female donors and for male donors. implementation of education leaflet for blood donors resulted in . % reduction of pdi in compared with (p > . ). the effect is more pronounced (p < . ) when comparing second and first half of (- . %). reduction is observed in all types of pdi with the exception of infections/contact (because they are mostly early pdi) and malignant diseases. the share of early pdi increased from . % in to . % in , which may suggest better awareness of blood donors on the importance to inform blood bank on changes in their health status. summary/conclusions: our study points to the importance of systematic recording and management of pdi, including education of blood donors about the need of providing all relevant facts related to their health and the safety of donated blood in a timely manner. we are planning further improvements by providing information on this topic on posters and screens on donation sites. background: currently, the transfer of data between organizations and/or computer systems is very limited, and where present is typically proprietary. in the absence of a standardized reference format individual organizations and vendors attempting to integrate disparate databases must develop unique solutions. aggregation of information from multiple sources is complex and costly, constituting a significant barrier to effective analysis of data to improve practice and inform policy. aims: to standardize the definitions and facilitate integration of key data items used in blood donation and transfusion. we report here on an initial effort to map internationally harmonized critical steps in the blood collection/donation process in order to test the approach. methods: through a collaborative process of serial conference calls and correspondence, an informal multi-national consortium of experts across the transfusion industry are attempting to create a vocabulary with sufficiently precise definitions to be usable by automated systems and that can be the foundation of a blood collection/transfusion medicine common data model (cdm), using the following steps: -define the scope of activity to be addressed and segment into key processes. -identify the set of data elements in each segment that are common to all systems. -review and consider existing standards and definitions for each data element. -develop draft definitions for each data element. -release draft to public domain for critical review and refinement with long-term goal of gaining widespread endorsement. results: a standardized approach to blood donation was mapped through identification of common pathways and core mappable data elements. denominator data associated with donor characteristics and blood collection was selected as the first segment to address. a dictionary (or vocabulary) of common terms has been created and will be presented for international comment. summary/conclusions: developing an international consensus on the core elements and their definitions across the transfusion chain is critical for data integration and automation efforts. the expected benefits of this endeavor include that it allows the establishment of algorithms to automate reporting and thus reduce hands-on staff time; reduces time and resources needed to integrate new databases; allows systems to continue to use existing concepts and definitions internally while also providing data output in a standardized format; supports the ability to consistently analyse, interpret and present information regardless of the data source; establishes data definitions against which new systems can be developed; helps to improve comparability of results by providing a common data model for researchers and policy makers; improves confidence in data integrity and reliability of the derived information as a © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - basis for rational decision making; and reduces data gathering effort and cost thus improving opportunities for more efficient/complex data analysis. standardizing the transfusion medicine dataset is the first step in achieving the automation of data transfer and analysis needed globally to drive patient safety, research innovation, and best business practices. further steps must address the precise methods of data exchange, identification of responsible entities for maintenance and further development, and engagement of computer system developers. red blood cell (rbc) alloantibodies develop in a subset of individuals following exposure to non-self rbcs through transfusion, pregnancy, or other activities; these antibodies can lead to difficulty locating compatible rbcs, acute or delayed hemolytic transfusion reactions, or hemolytic disease of the newborn. alloimmunization is underestimated due in part to antibody evanescence, the random nature of posttransfusion antibody screens, fragmented medical care, and the lack of widespread antibody registries. factors that influence who will develop detectable alloantibodies are not well understood. transfusion burden is one risk factor for alloimmunization, though many highly transfused individuals never form alloantibodies despite exposure to many rbc units (and many non-self abo blood group antigens). individuals with sickle cell disease (scd) and myelodysplastic syndrome (mds) are more likely to form rbc alloantibodies than most other patient populations. individuals with rheumatologic and other forms of autoimmunity, though not chronically transfused, are also at higher than average risk of forming rbc alloantibodies. inflammation, in a broad sense, is one common thread among these diagnoses associated with high prevalence rates of rbc alloimmunization. reductionist murine models support some types of inflammation (including viral-like stimuli) around the time of rbc exposure as being associated with an increased likelihood of alloantibody formation. strategies other than transfusion avoidance or extended antigen matching beyond abo/ rh would be beneficial to prevent new rbc alloantibody formation, especially in patients at highest risk. background: the unique genetic makeup of the omani population makes them rich in the genetic blood disorder. % of omani populations are Àa/Àa gene carriers, % Àa/aa, and % of the population are aa/aa. around % of omani nationals carry the gene for hbs, and - % carry the gene for b-thalassaemia. recent statistics show that there are around patients with thalassaemia major and with scd in oman. the other rbc abnormality that is common in oman is g pd deficiency which is found in % of males and % of females. omanis are known to have the highest frequency of a thalassaemia and g pd reported so far in any race. although blood transfusion is one of the supporting treatments of scd, it can cause some serious complications for the patients. alloimmunization of red blood cells is one of the consequences of blood transfusion. alloimmunisation of the rbcs can cause haemolytic transfusion reactions and may trigger hyperhaemolysis, in which transfused and patient's own rbcs are destroyed. alloantibodies can cause delay in the process of transfusion, it can be costly and time consuming. high number of patients developing alloantibodies may indicate a major difference in the patient and donor population. it may also indicate lack of a controlled, generalised sickle patients management policy. in oman the decision of transfusing scd patient is left to physicians attending the patient. aims: this study is aimed to highlight the increasing number of alloimmunised sickle cell patients. in the royal hospital we get new cases of sickle patient with alloantibodies each year. the acknowledgement of these cases may help in is assessing the current practice of transfusing scd patients, or will help to define the donor and patient population difference. methods: patients were recruited in the royal hospital for this study. edta blood samples were taken for antibody screening test and in the positive cases antibody was identified, all tests done by capture technique using immucor neo machine. results: of the scd patients, % of the patients were male and % female, mean age was years, in the range of - years. % of the scd cases were positive for the alloantibodies, % were female and % were male, the age range was from - years. % of the positive were scd, % s trait and % were s/ bthal. most of the patients developed one antibody, however cases of multiples antibodies were also detected. % of the patients were with single alloantibody, % of them with two antibodies, % with three antibodies, % with four antibodies and % with five antibodies. the majority of the cases were igg against rh antigens anti-e is being the majority %, followed by anti-d %, anti-k %, anti-c %, anti-c %, anti-jk a %, anti-jk b %, anti-fy a %, anti-e %, anti-s %, antis %, anti-kp a . %, anti-fy b . % and igm being %. summary/conclusions: rbc alloimmunisation rate is high in oman majority of the patient affected are female. interestingly sickle trait patients were also transfused and % of them developed alloantibodies. the practice of transfusing rh and kell matching blood unit is implemented four years ago and still high alloimmunization percentage is achieved. background: in ghana, routine pre-transfusion investigations for patients with sickle cell disease (scd) involve only abo-d typing and immediate spin crossmatch, without screening for irregular rbc antibodies aims: determine the prevalence and specificities of and risk factors for rbc alloantibodies in multi-transfused patients with scd methods: in , a cross-sectional study in multi-transfused patients with scd, from two tertiary hospitals in ghana was performed. participants' data on demography, transfusion and medical history were recorded. antibody screening and identification tests were done at sanquin, the netherlands, with standard serology using liss as enhancer and with papain treated rbc panel cells ('enzyme only'). characterization of rhd genes was done by multiplex ligase amplification assay. logistic regression was used to determine the association of patient characteristics, i.e. sex, age at enrollment (continuous), age at first transfusion (categorized as ≤ , - , - and ≥ ), previous pregnancy, number of transfused units ( , - and - and > ), and years after last transfusion (< , - , - , > y) with presence of alloantibodies results: patients ( males and females, median age years, range . - ) were included. the median number of transfusions was (range - ). the median years after last transfusion was (range weeks- . years). in patients, anti-rbc antibodies were detected. in of them the antibodies were weakly reactive with enzyme treated cells only or pan-reactive, possibly some of them representing autoantibodies or antibodies against high frequency antigens. in seven patients enzyme-only anti-le a was demonstrated, likely naturally occurring antibodies. thus, in at least patients ( . %) alloimmunization was demonstrated or suspected; in patients the alloantibodies were 'enzyme only'. besides, the alloantibodies of known specificity ( anti-d, anti-d+c, anti-e, anti-c, anti-e, anti-k, anti-s, anti-le a , anti-go a ), three antibodies reactive only with fy(a-b-) cells and two antibodies of yet unidentified specificity were detected. in six d-patients ( had been pregnant) anti-d (together with anti-c in two patients) was found. in three out of four d+ patients with anti-d, an rhd variant gene was demonstrated ( dau-alleles and diii type or diva- ). logistic regression revealed that none of the risk factors analysed was associated with the presence of antibodies in the patients. immunobiology -red cell alloimmunity fifty-eight patients, had experienced an adverse reaction during or shortly after transfusion ( patients had dark urine). adverse reactions were associated with the number of units received (or . ( % ci, . - . ; p = . ), but not with the presence of antibodies (p > . ) summary/conclusions: in at least % of multi-transfused patients with scd alloimmunization could be demonstrated, mainly ( %) directed against rh antigens. the enzyme only reactivity, coupled with absence of antibodies in seven of patients with probable haemolytic reaction and known evanescence of especially non rh antibodies suggest possible low titre and disappearance of some clinically relevant antibodies. given the high immunization rate together with the high frequency of adverse transfusion reactions, pre-transfusion screening for rbc antibodies should be considered for patients with scd. background: rh blood group system and mainly antigen d is one of the most immunogenic, diverse and clinically important protein-based blood group. antibody anti-d may induce hemolytic transfusion reactions and hemolytic disease of the fetus and newborn. anti-d prophylaxes become ineffective if an anti-d immunization has occurred. approximately % of the d+ population carries rhd alleles associated with reduced d antigen expression. qualitative variants, in which some epitopes are lacking and can produce anti-d antibody, are usually termed partial d. by contrast, d weak is commonly defined as a quantitative variant that have all d epitopes and should not make anti-d. del is a very weak form of d antigen and cannot be detected by routine serological tests. because some of del individuals have already developed an anti-d antibody whereas others did not this group contains both qualitative and quantitative changes. aims: investigation was prompted by finding discrepant results in typing of d antigen in a pregnant woman / rd pregnancy, st delivery, abortions in st trimester/. routine serological techniques detected d negativity and the presence of antibody allo-anti-d in clinically significant titre. the non-invasive testing of d status of the foetus from maternal peripheral blood was indicated, but this was not applicable due to presence of the rhd gene in the woman's dna sample isolated from buccal swab. our aim was to investigate the discrepancy and determine the underlying rhd genotype. methods: blood samples, dna from peripheral blood and buccal swab of the pregnant woman were investigated. routine blood grouping and antibody testing were performed by column agglutination. two anti-d sera (id-diaclon anti-d igg (cell line esd ) by biorad and anti-d duo igm+igg, clone: th + ms by immucor) were used for adsorption/elution test for identification of del phenotype. initial rhd genotyping was performed by rt-pcr (exons , , ) with the dna from buccal swab; further resolution was performed using pcr-ssp (fluogene; inno-train diagnostik gmbh); sequencing was performed by sanger analysis (inno-train diagnostik gmbh). results: genotype was identified as rhd positive by ce-certified pcr-ssp kits (fluogene). sanger sequencing of rhd from exon to revealed presence of a nucleotide deletion in position c. dela, which is specific for allele rhd* el. . this nucleotide change results in the amino acid change p.val leufs* causing the del phenotype. presence of antigen d was proved by adsorption/elution technique. titre of the anti-d was rising during the pregnancy to the level two weeks before the delivery. the newborn was delivered by s.c. without a sign of hemolytic disease. blood grouping of the newborn revealed blood group a, d negative, dat negative, testing for del was not performed. summary/conclusions: the case reported here shows that females with rhd* el. allele are able develop strong anti-d immunization, so this type of del phenotype belongs to the "partial del subgroup". presence of variant rhd gene in mother disabling antenatal fetal genotyping from maternal blood by current methods requires a more attentive approach to care for such pregnancies. supported by mh cz-dro uhkt and rvo-vfn . a-s - ea scharberg , s rothenberger , a st€ urtzel , n gillhuber , s seyboth , e richter , g rink and p bugert institute for transfusion medicine and immunohematology, drk-bsd ba-w€ u-he, baden-baden institute for transfusion medicine and immunology, heidelberg university, medical faculty mannheim, mannheim, germany background: rb a (di ) is a low prevalence antigen of the diego blood group system. it has been found in few families only. the clinical significance of anti-rb a is unknown so far. the slc a *c. c>t (p.pro leu; isbt allele name: di* . ) allele is the molecular basis of the rb a antigen. in the gnomad database this gene variant was found in only one of , sequenced genomes (allele frequency: . ). aims: to prove the frequency of the allele in our population and gain an rb a positive donor we performed a molecular screening for di in , blood donors. after our antibody screening test accidentally contained an rb a positive test cell we found out that anti-rb a is a very common antibody specificity. the frequency of the antibody in patients and blood donors was proved. methods: for the molecular screening of the blood donors we developed a pcr-ssp method. the antibody screening test in , patients and in blood donors was performed in the gel technique (biorad ahg id-cards) using a cell screening panel (drk-bsd src) including an rb a positive test cell. positive reactions with the rb a positive cell were confirmed by an additional rb a positive test cell of different source. additional antibodies were excluded or identified in the same method using an antibody identification panel (drk-bsd irc). results: the molecular screening for the di* . allele in , blood donors revealed no single positive individual. within the first weeks of usage of our antibody screening test which accidentally contained the rb a positive test cell patients with anti-rb a were found. it was . % of , patients tested in laboratories in different parts of germany. some laboratories stopped using the rb a positive lot to avoid expensive and time consuming identification and conformation tests. in of randomly tested blood donors ( . %) anti-anti-rb a was also present. summary/conclusions: despite the very low frequency of the di* . allele, anti-rb a is a very frequent unexpected antibody in patients and blood donors in germany. it is obviously naturally occurring and is even more frequent than anti-wr a and anti-vw we found in previous studies in around % of patients and donors. a-s - national blood center, ministry of health and sports, yangon, myanmar hemovigilance which detects every event not only for patient' reactions and donor's complications but also incidents and near misses definitely improve quality of blood transfusion services especially for those situations where implementation of all the standards in one time is not possible. healthcare system in myanmar is still in the stage of requiring priority for clinical professions and has limited resources for supportive roles. supportive services including transfusion service are still not a center of interest from prioritization of health care system. blood transfusion service has been practiced in myanmar since . real essence of transfusion service is hidden behind laboratory practice and transfusion is regarded as part of laboratory investigation. hospital laboratories take care of testing of blood donated by replacement donors. this kind of transfusion services under laboratory umbrella is still being practiced in myanmar except national blood center (nbc) which was established in in accordance with blood and blood product law. this law was formulated cohesively with who strategies of blood safety. in , who global data-based study sent questionnaires for assessment of safety status of transfusion service. nbc noticed that there was no data which can support corrective actions for safety. from that time onward, active retrospective review of existing data and introduction of records, prospective finding of process errors and any events from hospital blood banks were recorded and taking into actions at local level. cost of every unit of blood is supported by government. in , national blood and blood product committee was established. the steering committee is working hard to get cooperation from every service by aiming to prevent those undesirable events before establishment of national level policy, standards and guidelines for sustainable service quality. in conclusion, by using essence of hemovigilance as a tool, quality of transfusion service can be improved step by step to fulfil the gap in spite of limited resources. the system started in local, extends to regional level by getting agreement of importance from hemovigilance results and is finally approaching to national level endorsement. background: erroneous transfusion of abo-incompatible(aboi) blood almost always reflects a preventable breakdown in transfusion protocols and standard operating procedures and can have disastrous consequences, with significant morbidity and mortality. these incidents need to be investigated in a systematic manner to identify system vulnerabilities to mitigate risks and improve patient safety. since , reporters to shot have been asked to score( - ) the extent to which the cause of incidents can be attributed to key factors: staff, environmental, organisational and government/regulatory which helps recognise the key factors identified whilst investigating these incidents. aims: to understand why unintentional transfusion of aboi blood components continue to happen despite standard procedures and national guidance available. methods: retrospective analysis of unintentional transfusion of aboi blood components reported to shot between - (inclusive) was done to identify common themes and recognise areas of improvement. information provided using the shot human factors investigation tool (hfit) between - was reviewed to understand more about why the errors occurred. results: sixty-seven unintentional aboi transfusions were reported between - ; majority ( / , . %) were red cell transfusions but aboi plasma ( / ) and platelet transfusions ( / ) were also seen. most errors occurred in the clinical area ( / , %), and could have been detected at point of administration. in ( %) cases, the error could not have be detected at the point of administration with a primary laboratory error in / ( %) incidents. reviewing data from hfit for cases in - ( aboi cases), the total score for staff culpability was , compared to a total score of for all the other three organisational and system factors. this disparity is most obvious for the aboi red cell cases, all of which scored the maximum for staff culpability, i.e. / compared to / as the combined total score given to the other factors. in the preceding years ( to ), there were no hf scores available; however, the emphasis on staff-related culpability is demonstrated by cases that included an outcome of the local case review and ( . %) mentioned staff-related retraining or disciplinary procedures. the risk of haemolysis and serious harm is more likely with aboi red cells than with other components with / ( %) that resulted in death, / ( %) major morbidity and / ( %) no or minor adverse reaction. of these cases, one resulted in conviction for manslaughter and at least two staff dismissals. summary/conclusions: transfusion never events continue to occur, and it is evident that investigations into such incidents focus mainly on staff failings and do not consistently identify system wide changes that need to be incorporated to address prevalent issues. national recommendations and a safety alert to 'use a bedside checklist' immediately prior to administration were issued between - to support prevention of such errors but never events continue to persist. current approach is ineffective because it often leads to apportioning blame, rather than understanding the often-complicated and multidimensional factors contributing to the error. this must be replaced by a holistic approach which addresses local work pressures and embraces advances in automated technology like electronic prescribing and barcode scanning. of the confirmed trars, n = were possibly related to treatment, n = trars were probable, and n = were definitely related to treatment; n = trars were grade , n = were grade , and none were grade . in recipients of conventional wb, there were n = ( . %) ars, n = ( . %) fnhtrs, n = ( . %) taco, n = trali, and n = ( . %) unclassified transfusion reactions. of the confirmed trars, n = were possibly related to treatment, n = trar was probable, and n = were definitely related to treatment; n = trars were grade , n = was grade and n = was grade . there were mirasoltreated wb transfusions in pregnant women and trars ( . %), both grade and probably related. there were transfusions of mirasol-treated wb and transfusions of conventional wb in patients < years old resulting in n = ( . %) trars in recipients of mirasol-treated wb and n = ( . %) in recipients of conventional wb. summary/conclusions: timely data reporting of trars and expanding the hv infrastructure has helped to improve the hv system in ghana. of wb transfusions in routine use in ghana, there were . % trars in recipients of mirasol-treated wb and . % in recipients of conventional wb. additionally, mirasol-treated wb was safely transfused in pregnant women and pediatric patients. haematology, monash health, melbourne, australia background: transfusion-associated graft-versus-host disease (ta-gvhd) is rare and usually fatal. it can be prevented by provision of irradiated blood products to at-risk individuals, such as those receiving nucleoside analogues, alemtuzumab, bendamustine or with hodgkin lymphoma (hl). duration of risk is uncertain, so ensuring these individuals correctly receive lifelong irradiated blood components, as currently recommended by anzsbt and bsh guidelines, is challenging. in australia, platelets are routinely irradiated, but red blood cells (rbc) are not. aims: to determine whether patients receiving fludarabine, cladribine, bendamustine, alemtuzumab, or dacarbazine (for hl), appropriately received irradiated rbcs. secondary outcomes included rates of ta-gvhd after unintended exposure to non-irradiated components, factors influencing correct issue of irradiated rbcs such as transfusion management plans, and provision of adequate clinical information on blood requests. methods: we performed a retrospective audit to identify patients receiving therapies indicating risk for ta-gvhd using pharmacy dispensing records from january to october at monash health, a multi-campus university hospital in melbourne, australia. diagnosis, treatment dates, group and hold (g&h) requests, rbc transfusions, and follow-up information were sourced from laboratory and medical records. results: we identified patients who received fludarabine (n = , %), bendamustine (n = , %), cladribine (n = , %), dacarbazine for hl (n = , %) and alemtuzumab (n = , %). the median age of patients was years (range - ) and ( %) were male. median follow-up was months (range - ). post-exposure, patients ( %) received transfusions with % correctly receiving irradiated rbcs. the remaining , all from haematology/oncology, received a total of unirradiated rbcs. in patients, this was rectified on subsequent transfusions. there were no cases of ta-gvhd at median follow-up of . months (range - ) from first rbc transfusion. after medication administration, patients had g&h requests after a median of months (range - ). only % of requests had sufficient clinical information to prompt irradiation, such as hl or medication details, and only % asked for irradiated components. preventive strategies have now been employed. transfusion management plans for haematology patients were implemented in march . for audited patients, these were written from days prior to days after medication exposure. two were written following inadvertent unirradiated rbc transfusion. patients identified in this audit will have a laboratory flag generated and prospectively, pharmacy dispensing records will be sent to blood bank to identify at-risk patients. our hospital is transitioning to electronic medical records (emr). an alert will be generated in emr when ordering transfusions if there has been exposure to these medications. however, clinical awareness and documentation remain vital. additional measures include patient education, alert cards, and ongoing collaboration with medical staff to encourage transfusion planning. summary/conclusions: recognition of patients at risk for ta-gvhd remains low, even among haematology units. we are making progress on ensuring provision of lifelong irradiated blood components in patients exposed to nucleoside analogues or alemtuzumab, as well as hl patients. implementation of an emr and additional strategies in this domain is important to prevent ta-gvhd. background: blood transfusion is considered an essential element in the management of patients globally. it might be risky and transfusion related adverse reactions may occur with the less adherence of transfusion policies. standard guidelines regarding the screening of blood for infectious disease, genuine need of transfusion and abo compatibility are followed and monitored drastically. however, patient assessment during transfusion especially at patient bedside and post transfusion is also equally important. aims: we are a newly established hospital and are working towards the best possible management of patients. in this regard to minimize the transfusion errors and to highlight if any lacking being practiced during transfusion, we conducted this study to observe the compliance rate of documentation of transfusion form by the healthcare staff and also to observe the compliance of line of action taken in case of occurrence of transfusion reactions. methods: this was a observational study conducted at nibd and bmt, pechs campus from february to february . ethical approval was obtained prior to the study. transfusion form for each transfusion was filled. the form provided information on documentation of blood product receiver name, employee identity number, date and time of receiving blood product, patient name, medical record number on units, on patient's wrist band and on transfusion form. abo compatibility on the unit and on form, medical record number from wrist band, name and employee identity number of two healthcare staff started transfusion, transfusion start and completion time. time, temperature, blood pressure, pulse and initials of staff at the time of order, onset, after minutes and at the completion of transfusion were also included. transfusion reaction form was also filled by the healthcare staff. data was analyzed by using spss version . . results: a total of transfusions forms were analyzed. over all compliance rate was %. out of , ( %) forms were available in source notes and of , ( %) were partially and completely filled. higher compliance was seen in the initial months of hospital establishment than later months (p-value = . ). highest non compliance was seen in documentation of initials of duty doctors on transfusion form at the completion of transfusion( %) and highest compliance was seen in documentation of name by healthcare nursing staff at the start of transfusion( %). a total of ( . %) adverse events were reported from red blood cells and platelets. mean time of start of symptoms was hours and minutes for red blood cells and for platelets it was hour and minutes. transfusion was instantly stopped as the symptoms appeared with no delay of time and actions were taken to resolve the reactions. time of appearance of symptoms and time of start of medication were documented and error free. all blood bags were returned to the blood bank and discarded after hours as per the policy of hospital. summary/conclusions: the study was conducted to highlight the scarce practices that are being implemented by healthcare staff in context of documentation and reporting of transfusion reactions at our hospital. stringent actions should be taken for the adherence of compliance by healthcare staff to avoid morbidities and mortalities. we believe that it will also be helpful to provide baseline information in the process of preparation of a national guidelines and protocol on blood transfusion procedures. a-s - as buser, a holbro and l infanti regional blood transfusion service, swiss red cross, basel, basel, switzerland to make blood supply safer, pathogen inactivation (pi) technologies have been developed. they are based on photochemical (amotosalen/uva or riboflavin/ uv) or uv-c light treatment to reduce potential pathogens in blood components. this gain of safety might however be offset by "off target" effects of these technologies. in virtually all clinical platelet transfusion trials, it has been demonstrated that post transfusion increments with pi platelet (plt) components are lower as compared to conventional components, indicating different biological behaviour such as survival/ clearance of nontreated and treated plt. published studies have also suggested shorter survival of platelets in vivo in animal studies. additionally, data of the rates of alloimmunization and refractoriness after transfusion of pi platelets are show discrepant results. animal studies suggest a reduction of the rates of alloimmunization when transfusing (leukoreduced) pi plt as compare to conventional plt. in the clinical setting, published data, including very recent reports, showed different rates of hla class i and ii alloimmunization with the two currently available photochemical based pi technologies. while pi of plt components surely benefit patients regarding pathogen safety, the impact of potential off target effects possibly impairing efficacy of pi plt transfusions need more investigation. background: brucellosis is an endemic disease and still a major health problem in saudi arabia. ministry of health in saudi arabia listed brucellosis as a notifiable disease due to its endemicity. in the last ten years, the incidence has decreased significantly to approximately cases per , but is still higher than that in developed countries. human-to human transmission is extremely rare including breast feeding, transplacental, sexually and blood transfusion. five cases of brucellosis through blood transfusion have been reported in the literature. brucella transmission through blood transfusion is likely underreporting due to the long incubation time of - weeks (range, days to months),vagueness of clinical presentation and lack of hemovigilance systems in endemic areas. (allohsct) and ( . %) autologous (autohsct) hsct patients, with mean corrected count increments (cci) of . , . and . , respectively. mean cci decreased in a linear fashion between day ≤ and day pcs ( . , . and . at ≤ days; . , . and . at days, respectively), although the number of pc transfused on day to autohsct patients was small (n = ). background: nipah virus (niv) is a paramyxovirus (genus henipavirus) that emerged in the late s in malaysia and has since been identified as the cause of sporadic outbreaks of severe febrile disease in bangladesh and india. niv infection is frequently associated with severe respiratory or neurological disease in infected humans with transmission to humans through inhalation, contact or consumption of niv contaminated foods. nipah virus (niv) belongs to the list of pathogens identified by the who to have the potential for a global pandemic. aims: this study aimed to investigate the efficacy of the theraflex uv-platelets system to inactivate niv in platelet concentrates (pcs). the theraflex uv-platelets system (macopharma) uses uvc light without the need of any additional photoactive compound. methods: plasma reduced pcs from bcs ( % plasma in additive solution ssp+) were spiked with virus suspension ( % v/v). pcs (n = , ml) were then uvcirradiated on the macotronic uv machine (macopharma) and samples were taken after spiking (load and hold sample) and after illumination with different light doses ( . , . , . and . (standard) j/cm )). the titre of the niv (malaysia) was determined as tissue culture infective dose (tcid ) by endpoint titration in microtitre plate assays on vero cells (atcc â crl- tm ). the results of the infectivity assay demonstrated that uvc irradiation dosedependently inactivated niv. after spiking a niv titer of . (bag no. ) and . (bag no. ) log tcid /ml was received in the pcs. at a uvc dose of . j/cm and higher niv was inactivated down to the detection limit of the system ( . log tcid / ml), resulting in log reduction factors of ≥ . (bag no. ) and ≥ . (bag no. ). summary/conclusions: our results demonstrate that the theraflex uv-platelets procedure is an effective technology to inactivate niv in contaminated pcs. vs. ae . e platelets/unit, p < . ), whereas the platelet content of apheresis pc did not change ( ae . vs. , ae . , p = . ). summary/conclusions: pathogen reduction resulted in the transfusion of older pc on average, but without altering the number of pc ordered or the use of pc per patient. pathogen reduction has improved pc stock management without an increase in platelet demand, despite lower platelet content of buffy coat pc after pr implementation. donors and donation -donor adherence -are we doing the right thing? the transfusion procedure is the last step in a multi-process supply chain. the task of matching supply with demand requires donor managers to consider average consumption rates on a weekly or monthly basis, but to also have insight into variability in order distribution and possible attribute (blood groups) requirements. since hospitals and blood banks are usually not deeply interwoven and often only ex-post data is available, forecasting methods should be implemented. a thorough analysis of order pattern to set weekly target inventories and safety levels is required to close the information gap. a collection plan needs to identify possible bottlenecks which can be prevented through the planning of inter-shipping, changes in message urgency and building of reserve donor pools. constant analysis of collection and mobilization kpis allows donor managers to implement the rolling-wave planning approach and continually adapt to changing requirements, unexpected events and overall systematic variability. the variability happens on the demand side, as order quantities and their attributes, such as blood group distribution, are subject to change. however, also the supply is subject to significant variation, as donor response rates, attrition, deferrals and overall availability of donors are not constant. the data was collected with the face-to-face interview method right after the donation. first-time donors has attended to the study in regional blood centres in cities in turkey. the survey included items in accordance with the standard tpb predictors of attitude, self-efficacy, and intention. self-identity, anticipated regret, donation anxiety, paraphernalia anxiety, personal moral norm, descriptive norm, satisfaction, motivation also assessed for the first-time donors. the relation between the predictors and intention confirmed with correlation analyses. the predictors' distribution analysed by multiple linear regression. a number of goodness-of-fit indices were calculated and examined for each tested models (ibm, amos spss). the results of goodnessof-fit tests for proposed model provided a better fit to the data than these models (cmin/df = ). moreover, this result indicated that the fit between the proposed model and the data could be improved with further modifications with the inclusion of paths between motivation and attitude, self-identity and intention. moreover, inclusion the paths between donation anxiety and intention and between self-efficacy and attitude, on contrary to recent analyses suggesting opposite paths. evaluation of goodness-of-fit tests showed good result for revised model with a value of cmin/df = . , close to perfect fit. the revised model revealed that attitude was the strongest positive direct predictor of intention followed by personal moral norm, self-identity, motivation and anticipated regret (path coefficients: . , . . . , . , and . , respectively). donation anxiety was the negative direct predictor of intention (- . ). satisfaction was the strongest positive indirect predictor of intention via attitude and followed by self-efficacy ( . and . ). paraphernalia anxiety was the negative indirect predictor of intention (- . ). descriptive norm did not show any significance. our model accounted for . % of the variance in intention. summary/conclusions: these findings suggest several potential avenues for enhancing donor retention. the results obtained with this study provide important data from the standpoint of donor retention, which should be, implemented in the future strategies of turkish red crescent. background: transpose-transfusion and transplantation: protection and selection of donors, is a european consortium project, including partners from countries, reviewing donor selection and protection policies for substances of human origin (soho).one of the main issues in the current donor selection system, which transpose aims to tackle, is that for many, if not most criteria, is not evidence based. the transpose consortium therefore tries to re-assess selection criteria, revised them where needed and provide recommendations as evidence-based as possible. transpose additionally adds to the current european directorate for the quality of medicines & healthcare (edqm) guidelines by emphasizing donor safety. aims: the aim is to compare existing donor eligibility criteria throughout europe, and to compile a list of risks to consider, with evidence-or consensus-based deferral criteria to provide more uniform donor screening criteria. methods: there are three horizontal work-packages (wps); wp coordination, wp dissemination, and wp evaluation of the project, and four technical ones with specific deliverables and milestones to be regularly produced: -wp inventory of donor selection & protection practices; -wp development of risk-based guidelines for donor selection and protection; -wp development of a standard donor health questionnaire (dhq); -wp training course/workshop on the use of the guiding principles, guidelines and the dhq. the transpose project launched in september and will complete in spring . wp has completed its work in october, wp will complete its work in june , and wp and wp have recently commenced. results: with the use of the deliverables created by wp , we have created an indepth inventory of current practices in donor selection and protection, including overview of similarities and differences across european countries and across soho types. there is an agreement amongst experts that existing guidelines are often based on the precautionary principle rather than on risk assessment. consequently, in the development of wp 's guidelines for donor selection and protection, we now make an effort to also emphasize donor safety, in a more evidence-based way via the use of risk-based assessments. this will result in a standardized dhq with a common trunk and more in -depth questions per soho. summary/conclusions: the impact of the outcomes of transpose will be threefold. first, outcomes are expected to be of help in revising donor selection and protection related eu directives. second, the set of guiding principles and donor selection & protection guidelines will facilitate eu member states to take a next step in implementing donor selection and protection policies in a consistent and clear-cut way to the benefit of both donors and recipients of soho. third, a standard donor health questionnaire with carefully guided local/regional/national adjustments will become available per soho which can be used widely and will consequently enable comparisons of the prevalence of certain risks and risky behaviours throughout europe. background: transpose-transfusion and transplantation protection and selection of donors is a european consortium project, including partners from countries, that reviews donor selection and protection policies for blood, plasma, tissues, assisted reproductive technology (art) and stem cells (together soho). donor selection criteria (dsc) in europe are based on eu-directives, guidelines and countries' own additional criteria. literature shows that particular criteria are outdated or not risk-based, often leading to unnecessary donor deferral or an underestimation of risks for donors. aims: to ) provide a comprehensive inventory of current systems for selection and protection of donors and donations, ) critically review them and ) recommend an over-arching donor health questionnaire (dhq) including all necessary criteria currently used by different eu-member states (eu-ms). methods: in-depth semi-structured interviews with key stakeholders in blood collection were conducted to identify main topics for improvement in the current dsc. these formed the basis for a survey sent to professionals from collection institutions of all soho to get feedback on current systems from as many eu-ms organisations as possible. questionnaires were sent to a total of experts ( blood; plasma; tissues; stem cells; art) and ( %) completed questionnaires were received. where information was lacking, additional experts were asked to recommend upon dsc. results: for blood and plasma donation four main areas of concern in dsc were identified: risk-based selection, adaptability, flexibility and consistency. the stakeholders agreed that dsc are often outdated and lack evidence, hence leading to unnecessary deferral of donors and underestimated risks for donors. they suggested to base dsc on group risk-assessment (risk-based selection) and on conducting more research to achieve standardized risk perceptions and evidence-based deferrals, either for safety of recipient or donors. criteria could be made more detailed to fit specific groups to defer less donors (adaptability). furthermore, implementing criteria was considered easy, but abolish criteria when not regarded as a risk anymore seems almost impossible (flexibility). additionally, deferral periods are perceived too long, seen as both negative, i.e. jeopardizing donor return intention and positive, i.e. no risk for safety (consistency). changing legislation into guidance was an often-mentioned suggestion to improve dsc. specific feedback on plasma donations revealed that many whole blood topics are not applicable to plasma-only donors, e.g. parasite infections such as malaria (no deferral needed); travel history (no deferral needed), and recent bacterial and viral infections (deferral periods currently too long). a clear need for more research on plasma collection-related issues was identified. summary/conclusions: dsc are perceived redundant on a substantial number of aspects by most stakeholders. besides achieving the goal of save and sufficient soho for patients, many regulations could be improved to diminish deferrals and decrease donor risks. transpose will add to reviewing, improving and harmonising these regulations and criteria. furthermore, transpose will provide suggestions to improve directives and guidelines and a dhq, focusing on both donor health protection and safety of donations, but also removing deferral criteria that are not relevant (anymore), and offer a future research agenda to make dsc more evidence-based. background: transpose -transfusion and transplantation: protection and selection of donors, is a european commission co-funded project with participation of stakeholders from both not-for-profit and private blood collecting organizations as well as researchers and officials. the project aims to create new evidencebased donor selection criteria as well as guiding principles for risk assessment of threats to the safety of all substances of human origin (soho) except solid organs. as part of this, an inventory of current donation-related risks was performed, including an investigation of both type and number of adverse events reported. aims: we here aim to present an overview of reported adverse events in plasma and whole blood donation in europe and to compare this to the anticipated risks rated by transpose stakeholders. methods: national or local data on adverse reactions from the years - , both serious and mild, in whole blood and plasma donors was collected from the relevant stakeholders (eighteen and nineteen respectively). stakeholders were also asked to grade the most important anticipated donor risks according to severity, level of evidence and prevalence. we then compared the relevant risk categories as evaluated by the stakeholders with the categories of the provided data, as well as the heterogeneity of category numbers. results: thirteen stakeholders provided data on adverse events during whole blood donation in a given year, including in total thirty-three different categories of adverse events, ranging from only one unspecified reaction to seventeen different categories, with an average of nine categories per stakeholder. the most frequently used categories were hematoma (included by %), arterial puncture ( %) and nerve damage ( %). vasovagal reactions were also frequently included ( %); however, this was being done variably as vasovagal reactions unspecified, and acute and/or delayed vasovagal reactions. only one stakeholder reported iron deficiency. for plasma donation, seven stakeholders provided data on adverse events. a total of twenty-seven different categories were reported, ranging from one to seventeen per stakeholder, with an average of nine. the most frequently reported adverse events were hematoma ( %), citrate reactions ( %) and arm pains and nerve damage (both %, respectively). anticipated risks in blood donation were rated by nine stakeholders rating iron deficiency, vasovagal reactions and hematomas the greatest risks to donors. for plasmapheresis, six stakeholders rated vasovagal reactions, hematomas and citrate reactions as highest risk. summary/conclusions: as shown, categories used to describe adverse events in blood donation vary tremendously across europe, with some countries only being able to provide total numbers of adverse events without further specification. furthermore, there is a gap between perceived high donor risks and reported adverse reaction categories in donor vigilance for whole blood, as reports on iron deficiency are virtually absent despite being considered the most significant risk. our findings show the need for international collaboration on creating an international standardized donor vigilance system, to gather more insight into donor risks to protect the health of donors. plenary session -a glimpse of the future pl- - modern transplantation medicine has made significant progress within the last decades due to a better immunological understanding of rejection and advances in immunosuppression. however, the severe side effects of long-term, typically lifelong, immunosuppression and the shortage of donor organs remain the major restrictions in transplantation. the idea behind all research to improve transplant outcome has always been the modification of the recipient's immune system to ideally induce a specific tolerance towards the donor's graft. in fact, the immunological blindness of the recipient towards the donor's graft is achieved by a general reduction of the immune system's competence and represents a major burden for transplant patients. the idea of invisible organs is an entirely different approach to solve the problem: instead of inducing an immunological blindness of the recipient's immune system an immunological invisibility of the donor's organ is created. this is achieved by genetically engineering the transplant to eliminate the organ's immunogenicity defined by the gene products of the major histocompatibility complex (mhc) and minor histocompatibility antigens. in addition to manipulating the expression of mhc genes required for immune recognition, immune cloaking strategies are used to evade immune rejection. these approaches take advantage of creating an immunosuppressive environment and expressing immune suppressive molecules by immunomodulatory transgenes. mhc engineering and immune cloaking in an entire organ is achieved during ex vivo perfusion by lentiviral transduction of gene expression modifiers and transgenes to induce a permanent immunological invisibility of the organ. importantly, mhc engineering also prevents the presentation of minor histocompatibility antigens, which usually are not possible to match between donor and recipient, but which trigger potent immune responses and graft rejection. eliminating the targets of cellular and humoral rejection as well as creating an allograft-specific immune environment through immune cloaking camouflages the organ and equips it with a powerful set of defense weaponry. immune-engineering of transplants achieved during the inevitable ex vivo period of the allograft after explantation without the need to accept off-target effects allows keeping the recipient's immune system fully functional and capable to combat infections and cancer. in pre-clinical in vivo studies from rodents to minipigs a clear survival advantage of ex vivo engineered transplants could be demonstrated. this approach has the potential of eliminating the burden of organ rejection and immunosuppression, thereby sustainably increasing transplant survival, organ availability and quality of life. gene editing for sickle cell disease: re-expression of the fetal c-globin genes (hbg / ) could be a universal strategy to ameliorate the severe b-globin disorders sickle cell disease (scd) and b-thalassemia by induction of fetal hemoglobin (hbf, a c ). we have previously identified bcl a erythroid enhancer sequences, marked by hbf-associated common genetic variants, that are required for repression of hbf in adult-stage erythroid cells but dispensable in non-erythroid cells. recently we have optimized conditions for selection-free on-target crispr-cas editing in human hscs as a nearly complete reaction without detectable genotoxicity or deleterious impact on stem cell function. we demonstrate that cas :sgrna ribonucleoprotein (rnp) mediated cleavage at core sequences of the + bcl a erythroid enhancer results in highly penetrant disruption of gata binding motif, reduction of bcl a expression, and induction of fetal c-globin. erythroid progeny of edited engrafting scd hscs express therapeutic levels of hbf and resist sickling, while those from b-thalassemia patients show restored globin chain balance. moreover we find that hscs preferentially undergo nonhomologous as compared to microhomology mediated end-joining repair. nhej-based bcl a enhancer editing approaching complete allelic disruption in hscs appears to be a feasible therapeutic strategy to produce durable hbf induction. in this presentation, i will compare and contrast bcl a enhancer editing to other autologous curative gene therapy and gene editing approaches at various stages of clinical and pre-clinical evaluation. oxygen is vital for life. without oxygen death is assured for aerobic organisms. although everybody knows this fact a lot of medical acts forget to take care of it, leading to a lot of potential troubles. indeed, during cell respiration the glucose oxidation by oxygen gives carbon dioxide, water and energy. this energy also called atp is necessary for cellular metabolism and consequently for life. we have identified an extracellular hemoglobin coming from a marine worm, called arenicola marina, which is able to deliver oxygen to this animal living in the intertidal areas on the atlantic coast in france between the north sea and biarritz. this molecule called m was developed in the medical device named hemo life â . we have showed that this product was very efficient to protect organs before transplantation. a multi centers clinical trial performed under the supervision of pr. le meur from the chu of brest, on patients waiting kidney grafts showed a delay graft function reduced roughly by three between the two kidneys harvested on the same donor with and without hemo life â and grafted on recipients. in , a world first was realized in france by the pr. lantieri to georges pompidou hospital in paris, france. indeed, it was the first time that a patient received a second graft face. this surgery was realized with hemo life â and showed a very nice result according the pr lantieri, the anastomosis were very easy and no edema was observed. furthermore, we have developed dressing incorporating m making a product called hemhealing â . preclinical data on diabetic mice showed an increase of healing process. hemoxycarrier â , a therapeutical oxygen carrier, is also in progress of development in order to address ischemic diseases such as the sickle cells disease, myocardiac infraction and stroke. this universal oxygen carrier without blood typing, which is the ancestor of our red blood cell containing hemoglobin showed that it is able to deliver oxygen at different biological levels, cellular, tissues and organs and could address a multitude of medical applications. background: main goal of transfusion is saving life and/or improve the health status of human by "safe blood" which needs regular, voluntary, unpaid blood donors. donor recruitment is being more sensitive and challenging part of the blood supply system in actual global socio-economic conditions. achievement to enough voluntary non-remunerated blood donation (vnrbd) can be established by an efficient donor recruitment. efficiency of the donor recruitment has still close relation with blood donor recruiter although there are so many new tools. occupational specifications, rights and responsibilities of blood donor recruiter have wide range differences between countries which cannot be explained completely by the specific conditions of each country. also, a concrete document which has an international consensus was not existing on this subject. turkish blood foundation (tbf) has been organizing an international workshop since ; anatolian blood days (abd). "who is a blood donor recruiter?" was the topic of abd-vii at - march . aims: main aim of the workshop was to check and evaluate the existing systems of the participant countries. than create a model for clearly defining occupational specifications, responsibilities and rights of blood donor recruiter. methods: experts from countries participated in the workshop. those countries are albania, algeria, bosnia-herzegovina, estonia, france, germany, hungary, india, kazakhstan, lithuania, macedonia, montenegro, oman, portugal, qatar, romania, russia, saudi arabia, serbia, slovenia, sri lanka, tajikistan, turkey, uganda, uzbekistan. these countries reflect almost all religious, ethnical, social, cultural and economic situations of the world. a questionnaire which was analyzing existing systems at participant countries sent before the workshop. after country presentations different discussion groups were organized. below listed topics were announced at final declaration. results: donor recruiter: . should have university degree preferably in marketing and business administration field. . should have a certificate and/or professional experience in public relation . should have efficient skill in conversation, sociability, independence, self-confidence, reliability, resilience and conscientiousness as well as to work in a team . should get a special training which includes not only social topics such as public relation, marketing, etc. and medical topics related bb&tm before practicing alone as a donor recruiter . should be a permanent staff . should have basic salary and performance bonus might be given . is eligible to monitor and modify mobile team working period at blood drive . should participate the mobile blood drive which he/she has organized . should participate the group who will create promotional materials for national blood service . number at each blood establishment should be defined based on annual blood collection such as staffs for , whole blood collection annually in germany. summary/conclusions: in conclusion; both donor recruitment and retention are not easy tasks to undergo while public are aging, and birth rates are decreasing all around the world. dedicated blood donor recruiter whose occupational specifications, rights and responsibilities are clearly defined will be the corner stone of the success for providing enough safe blood for transfusion. ct smit sibinga and j emmanuel background: africa is a large continent with independent states and a total population of , , , (february ) . healthcare policies and strategies are developed through who's advocacy, guidance, and support from hq in geneva and the who regional offices; eastern mediterranean regional office (emro) supporting arabic speaking countries and the african regional office (afro) responsible for sub-saharan countries. population distribution is approximately . % urban. there are a large number of different local dialects and languages spoken. the main languages spoken are english, french, portuguese, spanish and arabic. countries are mainly classified by undp as being of low and medium human development index the africa society for blood transfusion (afsbt) has members in most countries, advocates for the development of sustainable and effective blood services, and has developed a stepwise level accreditation program. in emro held a consensus meeting developing a "strategic framework for blood safety and availability for - " with a set of priority interventions focusing on leadership and governance, cooperation and collaboration, provision of safe blood and blood products, appropriate clinical use of blood, and quality system management. in all member states of the african union (au) countries, in abuja, nigeria, pledged that national budget for health should be at least % of the national fiscal budget. in ministers of health of who member states endorsed that blood and blood products be included in the essential medicines list; these endorsements and who's universal health coverage (uhc), have yet to be fully implemented. aims: to analyze (gap-analysis) to what extend countries in africa implement the world health assembly resolution wha . on availability, safety and quality of blood products, which urges governments to ensure safe, accessible, affordable and available supplies of blood and components from voluntary non-remunerated blood donors, which meet clinical transfusion requirements and achieve national self-sufficiency, following who guidelines and recommendations. methods: to provide an overview of the current status of the blood supply in africa strengths and weaknesses, data from who's global status report on blood safety and availability were analyzed and used. the study has been descriptive and explorative. results: the report identified a number of areas requiring attention; principle amongst these were -inadequate funding; -lack of governance and leadership; -ineffective public education on blood donation; -absence of capacity building for clinicians on rational use of blood; -lack of haemovigilance and implementation of quality management systems; -the need for regulatory or oversight mechanisms. summary/conclusions: national authorities should address areas requiring attention if progress towards ensuring a sustainable safe and sufficient supply of blood products is to be achieved. key is the commitment and support of national governments, which should implement resolutions and recommendations agreed by ministers of health at wha and african union. background: the core function of the blood donation testing (bdt) laboratory is to screen every unit of blood collected from a donor for blood group type and infectious disease markers to ensure safety of the national blood supply prior to transfusion. the lab operates daily on two work shifts, comprising of staff on the morning (am) shift (from : to : ) and staff on the afternoon (pm) shift (from : to : ) on weekdays and staff on the am shift and staff on the pm shift on weekends. bdt lab has a staff strength of to be rostered for the work shifts. each staff is on a five-day work week and has to work pm shift and am shift per month on average. the higher number of pm shift leads to staff feedback that they do not get sufficient time in the evenings for family and social or leisure activities. a lean six sigma project was initiated to review the work rostering to improve the work-life balance of the staff. aims: the project aims to reduce the number of staff working on the pm shift without affecting the downstream processes and continues to meet the timely release of blood supply to the hospitals. methods: lean six sigma tools were used to study the bdt lab workflow process and to identify factors that contributes to the higher number of pm shifts that the staff has to take on. data on the turn-around time and the man-effort required for each screening tests performed was analyzed. a survey was also conducted to understand the preference of the staff on the acceptable number of pm shifts per month. results: the main contributing factor for more staff required to perform the pm shift is due to majority of the daily donation samples being received only in the evening. as this factor is beyond the control of the bdt lab, redeploying work from the pm shift to the am shift was eventually selected as the solution to reduce the number of staff needed for the pm shift. the screening test that was shifted was determined based on the test system that has the shortest turn-around-time and is able to allow continuous release of results. at the same time, most of the staff must be trained for that test system. a trial on the new roster involving staff on am shift and staff on pm shift was conducted. the total number of pm shift per month was reduced from to using the re-defined process. the % reduction translates to fewer number of pm shifts that the staff has to undertake and was able to meet the staff's expectation. summary/conclusions: with the adoption of the new process workflow, bdt lab was able to reduce the number of pm shifts that the staff needs to be rostered using evidence based process improvement method. most importantly, the lab has a satisfied team of staff with better work-life balance. background: preparedness of blood transfusion services for emergencies and crisis situations is an important issue concerned with patient and transfusion safety. aims: having an experience of delay in blood component supply in an emergency situation due to partial interruption of hospital information system (his), it is aimed to create a crisis kit and constitute an alternative work flow for emergency in crisis situations. methods: it is stipulated that the failure of his which is normally conducts all process for transfusion would be disabled in a disaster or crisis situation. a brain storm was made on possible challenges associated with disability of his during transfusion emergencies. according to the scenarios a kit was developed for the process management of transfusion emergencies. results: a flow chart was designed in proper with transfusion emergency definitions of who and instructions were written to explain the flow chart. all forms categorized with different colour codes are designed to fill with handwriting. the kit consists of flow chart and instructions, analysis request forms (blue coloured), blood component request forms (pink coloured), proceeding forms (green coloured), pens and blood sample tubes with edta were put into a plastic folder labelled as transfusion emergency disaster & crisis (tedc) kit. additionally, the kit is placed in a sealed clear plastic bag and delivered to all inpatient and intensive care units of pediatrics and pediatric surgery. a training programme concerned with transfusion emergency situations and usage of the tedc kit was developed for health care workers involved in blood transfusion process. pre and post-assessment tests were developed for the evaluation of effectiveness of the training programme. summary/conclusions: it's challenging to improve the response capacity of blood transfusion services during emergencies and crisis situations. abstract withdrawn. background: india is a developing country having licensed blood banks majority have manual documentation which causes inaccuracies and errors in blood bank activities. monitoring is a herculean task. computerisation is the need of the hour but this goal involves many hurdles and challenges aims: the aim of this study is to discuss the challenges faced during computerisation of blood bank activities and the remedial solutions for it methods: department of transfusion medicine, king george medical university, lucknow is one of the biggest blood bank of the country with annual collection of , blood units. two years ago, the blood bank worked on totally manual system. computerisation involved challenges associated with hardware and software installation and personnel training. hardware was installed in two phases. initially hp system but later shifted to apple imac due to frequent breakdowns. with hp server. software installation (easy software) involved erratic internet connectivity hence changed to lan. customisation involved radical changes according to our needs. at times we had to change our way of working to suit the software. biometrics linking, medical registration, cash id generation, donation, serological crossmatch, automated blood grouping, labelling, chemiluminescence & nat testing, blood component preparation and camps were all included with challenges at every level. remedial actions were taken from small to big. training of the staff was the most essential part of the implementation of computerisation who initially showed considerable resistance and at time faking ignorance due to apprehension that their mistakes will be highlighted and they will be penalised for it. it was a herculean task in creating their password protected identity and enforcing them to use it. gradually the staff realised that computerisation made their task easier as it cut down on paper work and repetition and also prevented serious mistakes from happening. hard copies at certain essential areas were still maintained to continue work in the event of major breakdown of computer results: computerisation aided us in regulating the movement of the donor which at times was repetitive due to manual entry. transfer of data ensured a safe supply and the mistakes could be retraced very easily. implementation which included installation, training and enforcement took a period of months. after overcoming all the challenges we minimised hard copies to registers and started taking printouts of the other necessary details. the turnover time for the employees due to computerisation decreased by %. waiting time for attendant decreased by %. traceability of all the units became %.supervision of the activities being carried out was % accurate. identification of the donors was easy due to biometrics which included thumb impression and iris scanning. the decision making time for donors decreased by % thus making the system more efficient. summary/conclusions: manual to computerisation involves involvement from source to supply and it is essential to anticipate the challenges and be prepared for solutions in order to make its implementation successful p- ct smit sibinga , y abdella and f konings iqm consulting, zuidhorn, netherlands who eastern mediterranean office, cairo, egypt background: who defined essential medicines (ems) as medicinal products that satisfy health-care needs of the majority of a population. they should be available at all times, in adequate amounts, in appropriate dosage forms, with assured quality and affordability. in blood and blood products (whole blood, red cells, platelets, plasma, and plasma-derived products) were added to the who model list of ems. appropriate and effective regulatory framework (legislations, regulations, etc.) and a functioning regulatory authority (ra) is crucial for management of blood products as ems. however, particularly in the less developed world, these prerequisites have barely been implemented. aims: to analyze and advise on existing legislation and regulations. existing legislative instruments of the member states of who eastern mediterranean region (emr) were collected and analysed for relevance and appropriateness for preparation and use of blood and blood products as well as use of associated substances and relevant medical devices. a literature search was done on matching combinations of regulatory system, regulatory framework, legislation, regulation, with production and use of blood and blood products, which resulted in almost exclusively references with respect to national and international legislation. benchmark: who recommendations (aide m emoires) and eu directives. methods: existing legislative instruments of the member states of who eastern mediterranean region (emr) were collected and analysed for relevance and appropriateness for preparation and use of blood and blood products as well as use of associated substances and relevant medical devices. a literature search was done on matching combinations of regulatory system, regulatory framework, legislation, regulation, with production and use of blood and blood products, which resulted in almost exclusively references with respect to national and international legislation. benchmark: who recommendations (aide m emoires) and eu directives. results: various formal legislative documents of only / countries are put in force by governments [ (egypt) till (pakistan -sindh)]. most are detailed descriptions of ra, operational establishments, and specific requirements. however, none of these legislations complies with who and eu recommended formats and contents, and will not support effective regulatory oversight to promote and enhance quality, safety and availability of these ems. summary/conclusions: government should provide effective leadership and governance in developing a national blood system (nbs, fully integrated into the national health-care system. essential functions of a nbs include an appropriate regulatory framework with legislations, regulations and other non-legislative instruments administered by a ra. these documents should spell out principles and cadres, standard setting, and organization of the blood system to ensure an adequate supply of blood and blood products and safe clinical transfusion for which a model was designed. the structure of nbs will depend on organization and level of development of the health-care system. however, all critical activities within nbs should be coordinated nationally to promote uniform standards, economies-of-scale, consistency in staff competency, quality and safety of these ems, and best transfusion practices. key is formulation of an appropriate regulatory framework administered by a ra responsible for regulating the vein-to-vein chain in the preparation and use of these ems. background: the capacity of blood transfusion service to provide adequate supplies of blood components is the issue of concern for health providers worldwide; longer term observations of trends in this respect are therefore of crucial value. aims: the study aim was analysis of some basic activities of the polish blood transfusion service in - including organizational changes, numbers of donors, donations and blood components as well as activities directed at increasing their safety. methods: retrospective analysis of data supplied by the regional blood transfusion centers (btcs). results: in the discussed period, blood and blood components were collected in regional btcs and local collection sites as well as during mobile collections. although the number of local collection sites decreased from in to in in favor of mobile collections, which increased from , to , , the former is still the number one location for donating blood. on average . % of all donations were performed in local collection sites. the total number of blood donors both at the beginning and the end of the discussed period was similar ( , in and , in ); over % of all donors were non-remunerated. however, the number of first-time donors dropped significantly (from , in to , in ). the total number of donations increased from , , in to , , in ; most frequent were whole blood collections (from , , in to , , in ) . some blood components (mostly plasma and platelet concentrates) were also collected by apheresis. most frequently prepared blood components were red blood cell concentrates -rbcs ( , - , , units per year), fresh frozen plasma -ffp ( , , - , , units) and platelet concentrates -pcs ( , - , units, with significant increasing tendency). additional processing methods such as leukocyte depletion and irradiation were more frequently applied to pcs ( - . % in respective years irradiated, . - . % leukocyte-depleted), than to rbcs ( . - . % irradiated, . - . % leukocyte-depleted). in , the pathogen reduction technologies in plasma and the pcs were implemented. up to date however the use of these technologies is limited in most btcs. in approximately . % of pcs and % ffp units issued for transfusion were subjected to pathogen reduction technologies. summary/conclusions: our study data may contribute to the assessment of some long-term tendencies observed in polish blood transfusion service and may serve practical-benchmarking. this in turn may prove beneficial to the transfusion community as a whole. background: in poland % of hospitals depend on blood for the treatment of patients; over . mln units of blood components are annually transfused. it is therefore purposeful to expand the knowledge on factors impacting on blood transfusion service (bts). the institute of hematology and transfusion medicine (ihtm) as competent authority is responsible for collection of data related to the activity of all polish blood transfusion centers (bcts). this data is exploited to a much lesser degree than the recently available statistical methods and data processing tools would allow. moreover, survey of research in the field of public health indicates a negligible share of issues related to bts. it seemed therefore necessary to "fill in the gap" with true assessment of performance of the polish bcts for improvement of bts activity. st stage of our investigation refers to collection, merging of data from different sources, their unification and preparation (big data) for further analysis to be performed using multidimensional statistical analysis and data mining methods. aims: assessment of the activity of the polish btcs over the year-period in two stages. goals at st stage: . data digitalization; scanning of paper documents. . development of a uniform template for collecting digital data from various sources. . standardization, unification and quality improvement of available data: filling in missing data, elimination of errors, duplicate records etc, that may distort the outcome of analyzes. . selection of data for analysis. methods: digitalization and big data methods for processing various types of data: a) stored in paper form ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , b) digital stored in two file types (.doc and .xls, for the years - and - , respectively). for each data-type, a separate excel file model was created. the models were then merged into one analytical table with data processing methods. results: . pages of paper documents were scanned. . models developed for data from different sources: a. paper-data were rewritten and ascribed to its model; outcome - tables, columns, , rows. b. .doc and .xls. filesdata were ascribed to other models; outcome - tables, columns, rows. . the models were merged into analytical table to create a mb database (comparable to approx. min of music). . the data was subjected to standardization, unification and quality improvement: filling in missing data, elimination of errors and duplicate records that may distort the results of analyzes. . selection of data for analysis at nd stage. summary/conclusions: the st stage provided a set of selected data for analysis in the nd stage which will rely on multidimensional statistical analysis and data mining methods. the outcome of such analysis will contribute to optimal realization of objectives: a) gaining in-depth knowledge about the fundamental phenomena that shape polish bts, b) identification of potential changes bcts, c) development of overall guidelines for change management. aimed to touch untouched or less touched topics of bb&tm. so far workshops were organized and each year around countries were participated from almost all religious, ethnical, social, cultural and economic situations of the world. . supported realization of major changes in bb&tm in turkey; a convincing medical individuals and agencies mainly moh to give the deserved consideration to bb&tm b encouraging the recognition and establishment of national blood program c issuing a new blood act and numerous necessary bylaws, etc. d creating an appropriate standard donor questionnaire form e changing blood transfusion practice from % whole blood (at ) to %. f changing donated blood screening criteria; while anti-hcv screening became obligatory malaria, screening cancelled g preparing national guidelines h promoting haemovigilance nurse post i promoting patient blood management . around , blood bankers attended national courses, , attended national congresses, , attended nationwide symposiums. summary/conclusions: bbtst can be accepted as a sample how a scientific nongovernmental organization may give a very positive impact on developing and progressing bb&tm activities with close collaboration moh and other related organizations abstract withdrawn. background: globally there is growing investment in information technology (it) in business. this similar trend has been observed in blood establishment computerized systems (becs). the it investment can be high hence it decisions need to be properly informed. the africa society for blood transfusion (afsbt) encourages the use of its in african blood services as this optimize quality blood services, thereby improving patient's outcomes. afsbt established in an it working group (afsbt itwg) with the support of the swiss red cross (src) to spearhead the it standards among member blood services. a number of priority it thematic areas were identified. these includes it governance which focuses on creation (strategic alignment) and preservation (risk management) of business value. there is absence of published literature on how a structured it governance framework can be implemented in a resource constrained setting. a review of the national blood service zimbabwe (nbsz) it governance was done based on published it governance framework. aims: to explore how a structured it governance can be developed, implemented and monitored in a resource constrained setting. methods: a published mit-cisr framework which has six components was used to assess the strength, gaps and opportunities of the it governance. results: nbsz has been implementing an evolving structured it governance system. in terms of service strategy and organization there is a well-established it function which is reflected in the nbsz strategic plans. this ensures it annual budgetary support, which averages . % of the total budget. the it governance arrangements are such that decision rights are assigned to different it staff (executives, it specialist, and users). a range of it solutions have been embedded within the nbsz operations such as becs, financial, donor mobile application, social media, temperature monitoring, and human resources. the business performance goals are defined and are congruent across the various business units. it organization and desirable behaviors are documented in the ict policies and procedures and were needed remedial actions are available through the code of conduct. the it metrics are included within the nbsz monitoring and evaluation system which use a four colored traffic lighting reporting system. it was noted that the it accountabilities are undesirably tilted to the it specialist only hence some ict projects tend to have delayed deliverables. the it governance mechanisms are supported with tools such as service level agreements and established communication approaches. simple excel based solutions are used to track critical performance metrics such as on the interactive blood supply management status, which averages . % ( ) based on a -day projected stocking and supply levels. nbsz need to properly document the return on investments on all these ict initiatives, which is estimated ( / ) to be at . % of annual savings. summary/conclusions: blood services in resource constrained settings can implement a properly structured it governance and this will ensure maximum return on it investments. the nbsz approach will be shared and further developed in the afsbt itwg to support other blood services in improving their it governance. haematology/blood transfusion, alfred health, melbourne, australia background: in october , an integrated electronic medical record (emr) was implemented at an australian metropolitan multi-campus heath service using cerner millennium tm , aiming to achieve himss (healthcare information and management systems society) level . prior to implementation, large numbers of blood specimens were collected from patients unnecessarily and sent to pathology without a test request attached (no blood test requested -ntr). these specimens required additional processing in the laboratory. electronic specimen collection using cerner specimen collect tm allowed streamlining of specimen processing by eliminating paper requests. as part of the new workflow, individual specimen labels are printed with the specified blood test and correct tube type. this helps prevent the practice of collecting additional specimens due to uncertainty of the collection requirements. aims: • to quantify the expected reduction in ntr specimens following introduction of electronic specimen collection, and outline the benefits • to determine the impact on collection errors and wrong blood in tube (wbit) events methods: data was obtained directly from cerner millennium tm using a ccl (cerner command language) query which is run monthly by pathology it staff. this data includes all specimens registered for the month with indication of rejected specimens, wbit & ntr samples. 'rejected specimens' includes incomplete specimen and/or request certification, unlabelled specimens/requests and mismatched specimens. further information about wbit events was collated from riskman reports and staff interviews. results: data from the months prior to emr implementation was compared with months post. ntr numbers reduced from /month to /month ( % reduction), freeing up more storage space in fridges. rejected specimens due to inadequate patient request labelling reduced from a mean of /mth to /mth. wbit numbers have increased slightly: before having median (range - ), after with median (range - ). although it was hoped that wbit incidence may reduce with the new emr, of the post implementation wbits involved electronic specimen collection. departure from planned protocols involving a lack of working printers, causing staff to print patient labels away from the patient's bedside, as well as multiple patient labels printing on individual printers appear to be a main cause of the emr wbits. summary/conclusions: emr implementation has led to a reduction in ntr, and rejected specimens due to inadequate request labelling, as well as increased storage space in laboratory refrigerators. associated benefits include: • decreased financial costs of the wasted equipment • decreased staff time collecting and processing unusable specimens • decreased environmental impact of manufacture and disposal of unused specimens • decreased potential of iatrogenic anaemia work in preventing the occurrence of further wbits is ongoing, by ensuring that label printers are in working order, are in plentiful supply and easily accessible to staff; and also ensuring positive patient identification and blood collection by the patient's bedside remains a priority. jm mustaffa , k teo , s tsai , p heng , r sagun and m wong laboratory medicine khoo teck puat hospital, singapore, singapore background: khoo teck puat hospital (ktph) is a -bed general and acute care hospital, opened in , serving more than , people living in the northern sector of singapore. the blood bank of ktph department of laboratory medicine provides specimen testing and blood transfusion services for ktph as well as the neighbouring yishun community hospital (ych), one of the largest community hospitals in singapore providing intermediate care for recuperating patients including rehabilitative services. the process of ordering transfusion-related test requests in both hospitals is through printed forms. aims: in line with the hospital directive to move towards electronic patient management, the ktph blood bank intended to implement an electronic type and screen (e-t&s) system. the goal of the project is to ensure zero patient identification errors and maintain full traceability and accountability for the blood collection process in all transfusion-related testing. another aim of the system is to reduce repeated venepunctures when specimens are rejected due to missing essential patient information on the printed forms by implementing mandatory fields in the e-t&s form. methods: the e-t&s was implemented in phases. phase : an online version of the printed form was signed electronically by the ordering doctor and a witness within the electronic medical record system, sunrise clinical manager (scm) system with the doctor counter-checking by signing on the specimen label to ensure correct patient identification. phase : the ordering doctor is not required to sign on the specimen label since fingerprint biometrics are required for the electronic signin. phase : elimination of the witness step for blood collection. specimen collection and rejection data from to was analysed. specimen rejection rate was presented as percentage of rejected specimens (mislabelled, unlabelled and clerical errors) over total specimen count for each month. results: between january and march , before the implementation of the e-t&s phase , the average rejection rate for blood bank specimens was . % and . % for identification and clerical errors respectively. during phases and of implementation, rejection rate increased due to unfamiliarity to the new work processes. by february , with the implementation of the final phase of the e-t&s system the specimen rejection rate was . % and . % for identification and clerical errors respectively. rejected specimens were mostly from the few locations that had to use paper requisition due to workflow or infrastructure limitations. summary/conclusions: the e-t&s system was implemented successfully in ktph. full traceability and accountability of the blood collection process was maintained with the fully electronic system. the adoption of electronic documentation has also reduced the number of preventable repeated venepunctures that were due to incomplete order information on the printed forms. future developments in technology and full implementation of e-t&s system in all hospital locations may make zero patient identification error achievable and ensure transfusion safety in all patients in the near future. background: blood component administration represents a critical phase due to the possible occurrence of errors during the different steps from the identification of the patient to the infusion of the product. error occurrence can be reduced by the implementation of validated information systems. we tested the scweb â system at the bedside in a transfusion outpatient clinic. aims: the aim of the study is to validate a system designed to assist and to control blood administration step by step using electronic devices to ensure traceability and documentation of the process methods: the scweb â system is based on it monitored checklists which guide the personnel to follow the procedure, according to best practices; the system must initially be activated by the operator which is recognized by an auto-signing system based on bluetooth low energy which avoids the operator having to identify himself/herself beforehand. appropriate privacy protection is provided. thereafter the system takes up the task to give instructions and to verify the adherence, by asking an active confirmation of the proper fulfillment of the activities; a continuous registration and documentation is made by the system. standards and specifications for each step of the procedure have been configured on scweb â system to track in detail operator and patient identification, presence of informed consent to transfusion, blood pressure, pulse and temperature recording, vein access, verification of the blood unit. an alarm has been set after min, to ensure the control of patient's conditions. for each step, an active confirmation of the action is required and nurse and doctor direct involvement must be actively confirmed on the device by both operators. the system has been tested at the bedside on patients admitted to the outpatient clinic for red cell concentrate transfusion; compliance of the personnel and organizational impact has been recorded. results: the system required a very short training: ease of scweb â system allows its implementation without negative impact on organization of transfusion outpatient clinic and without difficulties by operators (nurses and doctors), who appreciated the help given by the it check system. the registration of the electronic check list offered a reliable tool for the traceability of the transfusion procedure, also granting a paperless and timely available documentation of the entire process through a registration in electronic format of all the operator's action in every single phase of the transfusion process. when prescribed, confirmation of the checklist was only possible in the presence and with the active confirmation of two operators (doctor and nurse). summary/conclusions: the scweb â system is useful as a barrier against the mismatch of transfusion (preventive measure), as a traceability and documentation measure and as a tool for training of personnel in blood transfusion administration; it avoids paper registration during the transfusion process, due to the timely registration of the activities performed by operators recognized by the system thanks to the bluetooth low energy auto-signing device. the scweb â system will be connected to the transfusion data management system, to monitor all the process from the arrival of the unit from the blood bank. background: he blood banks aims at reducing cost and increasing customer satisfaction by providing quality in service. the quality in service can be attained by streamlining the processes and restructuring the supply chain of the organization by implementing it tools. aims: aim is to understand the complex flow of information and processes within the supply chain of the blood bank. the requirement of such a study is a part of the integrated erp modeling for the integrated functioning of a blood bank. methods: he approach used to understand and map the sequence of processes, and the work responsibilities of each process and the operational decisions involved at each step is process mapping and data flow diagrams for front end system modeling and analysis. the processes are mapped and represented in a schematic diagram. dfd (data flow diagram) are constructed for representing the system. a context diagram is also constructed for understanding the entities interacting with the system. the emr systems aim at replacing (or supporting) the paper based medical records. the whole model of the system is divided into two parts-front end and back end. the front end design and analysis is done using epc (event-driven process chains), resource views, data flow diagram for data view. reporting was on donor selection, finance and collection of blood bag, blood collection process, component preparation, blood testing and blood distribution results: process mapping using event driven process chain generated a whole view of the processes involved. the resource view gave an organizational structure and the personnel involved. the data view using context diagram and data flow diagram gives a flow of data and amount of data involved. this framework can be used for business process reengineering for the blood banks by conducting a time study and removing non value added activities. data view helps analyze redundant data in each process. it also helps in staff training and orientation within the department. summary/conclusions: a systematic overview presented in this paper facilitates in removal of non value added processes, duplication of data, bottlenecks, reduction of cycle time and thereby improving service quality in blood banks. background: the transfusion of blood components, one of the most prevalent interventions in clinical practice is a major expenditure item in healthcare services which tend to increase in recent years. aims: it is intended to investigate the impact of transfusion associated costs to hospital costs in pediatric intensive care unit (picu) patients. methods: during a year period (january -december ) patients, females and males receiving transfusion with blood components along the stay in picu were included in the study. transfusion associated costs and total costs for healthcare services for children treated in picu was collected by using hospital information system (his). statistical analysis of data was performed by spss software (version . , spss inc., chicago, il, usa). mann-whitney u test and kruskal-wallis test was performed for comparison of independent categoric variables and numeric data; chi-square analysis was performed for comparison of two numeric variables and spearman correlation analysis was performed for associations. results: the median age of patients was . months (interquantile range-iqr ). the median length of stay was days (iqr ). in total blood components were transfused in which of red blood cell concentrates, apheresis platelet concentrates, granulocyte concentrates, fresh frozen plasmas, and cryoprecipitate and whole blood. the ratios of transfusion associated expenditures to hospital costs were categorized in intervals of percentages as < %, - %, - % and > %. most of the patients ( . %) were ranked in the lowest interval. the medians for hospital cost and transfusion associated cost were . euros (iqr = . ) and . euros (iqr = . ), respectively. a significant strong positive correlation between numbers of transfusions and hospitalization cost of picu was detected (r: . , p < . ). while it was found a significant weak positive correlation between transfusion associated cost and hospital cost (r: . , p = . ) there was also a significant weak positive correlation between the age and transfusion associated cost (p = . , r: . ). a significant difference was found between the patients with and without hematological malignancies (p < . ) for transfusion associated cost. the reason why pediatric dosages are mostly prefer is that the hospital provides healthcare for only children and splitting of the blood components was common in the hospital. but unexpectedly a significant increase on the transfusion associated costs which is related to split blood components was detected (p < . ). summary/conclusions: studies on the economics of blood transfusion have been conducted mostly in patients who require chronic or multiple transfusions. picus, specialized facilities that provide care for patients with severe life-threatening diseases are major departments often necessitate multiple transfusions. there are many variables to evaluate the impact of transfusion associated cost to hospital cost in picu patients, but the major factors are underlying conditions, admitting diagnoses and transfusion strategies. although there are unexpected data in our study demonstrated the increasing impact on transfusion associated cost originated from blood components split for pediatric usage no significant relationship was determined to explain this situation. further studies on the economics of blood transfusions have to be carried out to clarify the variables of transfusion associated costs. background: approximately . % of the transfused blood component is packed red cell (prc). over ordering of prc unit is a common practice and excessive pretransfusion testing was being wasteful of resources and have adverse consequences on cost. high crossmatch to transfusion (c/t) ratio as quality indicator of blood bank implies that crossmatches were performed unnecessarily. aims: the aims of this study were to evaluate the cost effectiveness of strategies for limiting the number of pretransfusion testing of ordering prc. methods: all prc units who ordered from dr. hasan sadikin hospital from january to december were collected in this retrospective study. number of ordering prc unit, completed pretransfusion testing of ordering prc units, and prc units that were transfused were recorded. restrictive pretransfusion testing strategies were done based on the hemoglobin level and diagnosis as transfusion indication criteria. cost effectiveness was measured by multiplying the unit cost of pretransfusion testing and number of prc unit. results: out of total , ordered prc unit, , ( . %) were subjected to pretransfusion testing and . % ( , ) of ordering prc unit which are pretransfusion testing were transfused. this means that . % ( , ) of ordering prc unit were not subjected to pretransfusion test. this showed savings of , , , rupiah. c/t ratio was . which demonstrate a good ordering pattern. however, . % ( , ) of completed pretransfusion testing of ordering prc unit were not transfused, leading to blood bank loss of , , , rupiah. summary/conclusions: strategies for limiting the number of pretransfusion testing on the good c/t ratio was still associated with saving cost effective background: blood is a precious resource for saving patient lives. the purpose of blood and blood component therapy is to provide suitable and safe blood products to achieve best clinical outcomes. nurses have an important role in ensuring safe blood transfusion. it is crucial for nurses to have sufficient knowledge about blood donation and collection, storage, component preparation, possible adverse effects of blood transfusion and necessary management and care. aims: the aim of this study was to assess the impact of an educational intervention on knowledge and awareness of nurses regarding blood transfusion services and practices. methods: the baseline study to assess the knowledge and awareness regarding blood transfusion services and practices of the nurses posted at various areas of the hospital including wards, operation theatres and critical care areas was carried out at our institute hospital which is a tertiary care teaching centre. the nurses were then sensitized and educated regarding blood transfusion services and practices during their day to day activities by referring them to the blood transfusion guidelines of the institute. subsequently, a self-developed questionnaire which was used for the baseline assessment of knowledge and awareness of the nurses was again used to reassess them. a total of questions were included in the questionnaire pertaining to: general awareness (two questions), blood donation (two questions), testing and blood component preparation related (two questions), storage of blood/blood components (two questions) and pre-transfusion checks and bed side transfusion practices (eleven questions). fifty nurses each were included for both the baseline as well as post-sensitization assessment. for different category of questions, the correct response rates were compared with those obtained in the baseline study using mann-whitney test. the entire study duration was spread over a period of three months (december, to february, . results: the overall mean percentage of 'correct' responses for questions in the baseline study was . %, whereas post sensitization it was . %. the mean percentage increase in general awareness related questions was . %, . % for storage of blood/blood components related questions, . % for pre-transfusion checks and bedside transfusion practices related questions, . % for testing and blood component preparation related questions and . % for blood donation related questions. the percentage increase in correct response was found to be statically significant for each of the five categories of questions. the overall mean percentage increase in correct response rate was also statistically significant (p < . ). summary/conclusions: this study revealed that after sensitization and educational intervention there was a significant improvement in the knowledge and awareness of nurses regarding the blood transfusion services and practices. abstract withdrawn. background: tact, introduced in the uk in to support managers, provides resource-saving, continual, 'real-time' monitoring of knowledge-based competency of staff in transfusion laboratories. tact is available online / , complementing existing practical competency schemes and external quality assessment. multiple variations on a standard pre-transfusion testing scenario are generated using constrained randomisation; logic rules for automatic assessment of sample acceptance, abo/d, antibody screen and identification (as/id), and component issue are based on bsh guidance. during , tact was offered internationally to transfusion laboratory managers to trial, and saw uptake in five countries. the core tact programme, based upon uk guidelines, is under review for programming conversion, to be customisable for the international community. aims: to assess the feasibility of tact programming conversion to meet the requirements of country-specific pre-transfusion testing guidelines, and to direct future programming in line with feedback from international users. methods: guidelines from / international users were obtained and translated where necessary. these were compared against the core assessment elements of current tact programming. international users were approached for their feedback on the current version of tact, as it compared to their local policies and practices. results: the following criteria were cross-referenced: specification of transfusion request forms, sample label acceptance criteria, reagents used for abo/d and as/id, resolution of grouping anomalies, alloantibody confirmation/exclusion, and selection criteria of blood components for transfusion-dependent patients and women of child-bearing potential. apparent differences included:-australia:--selection of red cells for patients with immune anti-d. greece:--inclusion of the name of the patient's father on the transfusion request. italy:--testing of all new patients with an anti-a,b reagent and two different monoclonal anti-d reagents. international users in the same three countries supplied feedback. this included suggestions for:-greater complexity of cases presented, provision of patient history, inclusion of follow-on tests e.g. phenotyping and cells for antibody confirmation/exclusion, broader range of reaction strength grading, and official professional cpd credits. the following differences were noted:-nomenclature used, the format and content of the request form, use of english abbreviations of patient clinical details, and the availability, provision and specification of blood components. summary/conclusions: this analysis has shown very few instances where the current tact iteration differs from the guidelines reviewed, and that it is feasible to expand the use of tact on a more international basis. the current iteration of tact has been developed to represent an abbreviated scope of pre-transfusion testing practices, which can be applied to laboratory practice outside of the uk without difficulty. further work is required to enable international users to configure tact such that the system represents all laboratory practice on an international basis. aims: these courses provide education to clinicians on patient blood management and safe transfusion in neonatal and paediatric settings in order to improve patient outcomes and increase awareness of the national patient blood management guidelines. this analysis aimed to investigate the uptake, practical use, and perceived value of the courses by learners. methods: a retrospective analysis of course completion statistics and course evaluation data. results: there have been , paediatric and neonatal courses completed from march to february with . % of learners being nurses and/or midwives. analysis of course evaluation data (n = ) showed that these courses: -provide knowledge ( . %) -improve patient safety and outcomes ( . %) -result in change to clinical practice ( . %) -are relevant to clinical practice ( . %) -are easy to use ( . %) -are readily accessible ( . %). examples that learners provided of how they can apply this learning to their clinical practice include: -"[i am now] more aware of special requirements for neonatal blood transfusion" -"[i] feel more confident especially when talking with parents" -"[i will now be] checking the patient's blood results and will speak up for unnecessary blood sampling" -"[it's good that] when there is ambiguity in clinical practice [this is] very well shown by explanation from experts in the field" -"we don't do a lot of transfusions [and this is] a reminder that transfusions are not always the first answer to the baby's clinical picture". summary/conclusions: analysis of course and user evaluation data demonstrates that these courses are being used by nurses and doctors working in the neonatal and paediatric settings and that they provide knowledge of pbm that can be applied to clinical practice, thereby contributing to improved patient care. background: blood transfusion is a high-risk clinical activity that must be mastered both theoretically and practically in order to guarantee the required result without any incident or complications. the mastery of transfusion knowledge among nurses represents a very important link in the transfusion chain. the objective of this work is to compare the theoretical and practical knowledge of transfusion among two groups of nurses divided according to their seniority. aims: this is a cross-sectional descriptive study conducted over a period of month [ st april- th april] . we selected two groups of care staff: the st group consists of students at the end of their training at the higher institute of nursing sciences. the nd is made up of nurses working in university hospitals of tunis, currently practicing blood transfusion. the evaluation's tool used was a questionnaire of simple or multiple choice questions, were related to theoretical knowledge of labile blood products and to transfusion practice. ten questions were considered "life-threatening" if their answers were false. a comparative study was made between the two groups. methods: this is a cross-sectional descriptive study conducted over a period of month [ st april- th april] . we selected two groups of care staff: the st group consists of students at the end of their training at the higher institute of nursing sciences. the nd is made up of nurses working in university hospitals of tunis, currently practicing blood transfusion. the evaluation's tool used was a questionnaire of simple or multiple choice questions, were related to theoretical knowledge of labile blood products and to transfusion practice. ten questions were considered "life-threatening" if their answers were false. a comparative study was made between the two groups. results: the participation rate in the survey was %. the nd group participants had an average seniority of years . more than half of them ( %) had seniority of less than years. only % had more than years of experience. the rate of correct answers for all items combined was . % for students versus . % for practicing nurses. the theoretical knowledge part was more mastered in the st group than that of practicing nurses ( . % vs . % of correct answers). on the other hand, the control of the transfusion act was better in nd group ( % vs . %). the overall "dangerous" response rate was % for students and . % for practicing nurses. false practical knowledge was more common in group ( . % vs. . %). summary/conclusions: the theoretical as well as the practical knowledge remains not well mastered by the care staff. our study highlighted the best theoretical mastery for young students and practical for practicing nurses. this could be explained by the freshness of knowledge in the first group and the daily practice in the second group. background: the european commission (ec) directive / /ec on blood donor selection criteria is years old. in the meantime, knowledge on risks related to blood donor selection has progressed and challenged several obligatory rules. transpose -transfusion and transplantation: protection and selection of donors, is a european commission co-funded project with participation of more than stakeholders from both not-for-profit and private organizations providing substances of human origin (soho). the project aims to provide evidence-based donor selection criteria and guiding principles for risk assessment of threats to the safety of soho. as part of this work, an inventory of current blood donor selection criteria in europe and an evaluation of the evidence behind current practice was performed by experts working on this project. aims: to identify the gap between the ec directive / /ec on whole blood donor selection criteria and a current evaluation of the clinical relevance of the criteria based on scientific literature by a panel of european experts within the transpose project. methods: in , we performed an inventory of blood donor and transfusion recipient risks in participating european countries. project members were asked to provide the existing donor selection criteria related to these risks and to carry out a risk-based evaluation for each of them. the evaluation was based on the available scientific literature and on a risk assessment template based on the abo risk-based decision-making framework, developed by transpose. all risks with divergent assessments within the panel were resolved through discussion; in all cases an expert consensus was established. subsequently we compared the results with the content of the ec directive / /ec for every risk, thereby identifying discrepancies and missing items in the directive. results: the panel identified risks considered to be significant, distributed between donors and recipients. for / ( %) of them the expert evaluation deviated from the content of the ec directive, or the ec directive provided no information about the decision making. in particular, a discrepancy was observed for / criteria concerning general health and medication, / for transfusion transmissible infections, / for high-risk behaviour and travel, and / for other diseases. summary/conclusions: our results highlight a significant gap between the whole blood donor selection criteria stated in the ec directive / /ec and the scientific evaluation performed by a panel of transpose participating experts. this gap includes both new risks not addressed in the ec directive and addressed risks that are however evaluated differently. this involves both blood donor and transfusion recipient safety, and various medical and epidemiological topics covering several aspects of the blood donation criteria. we strongly recommend a change in the european legislation, allowing a procedure to guarantee that blood donor selection criteria are updated regularly within the framework of the european institutions, to keep aligned with scientific progress, epidemiology and changes in medical practice, in order to enable an updated risk-and evidence-based framework for donor selection criteria. the risk-assessment method elaborated in the transpose project is a valuable instrument for this purpose. background: the brazilian health regulatory agency -anvisa has developed the method for assessment of potential risk in hemotherapy services (marpsh) which is based on the data collected during the inspections of blood services carried out by regulatory authorities. using marpsh any blood service can be classified in one of possible potential risk categories: high, medium-high, medium, medium-low and low risk. each category represents a different potential risk level, according to the proportion of compliance with the established regulatory requirements. marpsh has been used since , showing a trend of risk reduction on blood services evaluated all over the country. aims: this work aims to describe the utilization of marpsh as a tool for an integrated risk management model. also, it shows the main results obtained after years of data monitoring and coordination of regulatory actions and policies by anvisa, targeting quality and safety of blood products. methods: the utilization of marpsh follows a network risk management model since the inspections are carried out by decentralized organs in all states and some municipalities. the inspectors fulfill a standardized inspection guide containing the regulatory requirements, where each item is associated with a level of risk, varying from i to iii as the risk increases. at the end of the inspection, after a statistical calculation, the service is categorized. this classification gives an estimate of its quality profile, guiding the adoption of suitable measures for risk management by local authorities and services. these data are send to the states (if realized by municipalities) and to anvisa that perform consolidation in a national level. either states or anvisa use data to coordinate risk management measures in a broader spectrum. data are continuously monitored by anvisa as part of its strategical panel of indicators. anvisa follows up specially blood services in high and medium-high risk with the aim of helping or complementing local authorities' actions. additionally, anvisa periodically sends this information to the brazilian ministry of health and local governmental organs from brazilian national blood system that also support actions to improve quality in their blood services networks. results: since , when the assessment covered blood services, marpsh reached blood services in ( % of the blood services registered) what corresponded to almost % of the inspection cover in this year. over this period ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) it is possible to notice a dramatic decreasing in trend for proportion of blood services classified as high and medium-high risk, varying from % to %. summary/conclusions: marpsh generates data necessary to the categorization of blood services into five levels of potential risk. as a result, the regulatory actions are applied by local organs with the purpose of reducing or eliminating risks involved in the production and use of blood components. data have shown a significant risk reduction over years of marpsh's utilization. additionally, monitoring of this data at a national level has been permitting appropriate planning and prioritization of integrated strategies directed to risk management and strengthening of blood services in brazil. background: sub-saharan africa has the highest need of blood transfusion in the world, mainly for childbearing women and children suffering from malaria. meeting basic quality and operational requirements to provide patients with safe blood remains a challenge in these settings. aims: the aim was to identify and prioritize potential hazards for patients in blood bank practices in the democratic republic of the congo (drc). we focused on two subsets: (i) sensibilisation and selection of donors, and (ii) qualification and production of blood products, using failure mode effect analysis (fmea). methods: two risk analysis workshops were organized at the national blood transfusion centre in kinshasa, the democratic republic of the congo. in both workshops, a multidisciplinary team was invited to represent different hospitals and profiles in transfusion management in drc: quality coordinators (n = ), training coordinator (n = ), medical doctor for donor selection (n = ), hemovigilance officer (n = ), laboratory technicians performing donor sampling, blood qualification and production (n = ), biomedical scientists (n = ), microbiologist (n = ), clinical biologist (n = ), nurse (n = ). the principle of fmea was applied, which implies identification of possible hazards (failures) in a process flow, followed by scoring each hazard according to their impact, probability, detection and feasibility. in the both workshops, participants were guided by an external facilitator who guaranteed common understanding of the methodology. main focus of the risk analysis was potential harm to the transfused patient in the process of (i) sensibilisation and selection of donors, and (ii) qualification and production of blood products. all ideas were written on coloured cards and mapped on a chart according to their impact, probability, detection and feasibility score. hazards were ranked according to their final risk score by multiplying these four scores. results: in the process of sensibilisation and selection of donors, the three hazards with the highest final score for impact, probability, detection and feasibility were: (i) a paid donor is recruited after sensibilisation by family members of the patient, (ii) donor selection staff approves a non-eligible donor for blood donation because of personal/financial motivation, (iii) blood donors are not correctly informed about blood donation during sensibilisation by family members of patients. in the flow of qualification of blood products, highest scores were made for: (i) no double check for validation and sorting of qualified blood products, (ii) stock-out of reagents, (iii) no check for match between registered test result and tested blood tube. regarding production of blood products, the top three consisted of: (i) transport time between blood collection and processing is > h, (ii) storage of qualified and quarantined blood products in the same fridge (some sites only), (iii) power cuts. summary/conclusions: the risk analysis resulted in three prioritized hazards in the process of donor selection/sensibilisation and blood product qualification/production. some are very specific to the sub-saharan african setting and have been described before (power cut, family and paid donors, stock rupture,. . .). an action plan needs to be put in place to reduce their final risk score. the risk analysis needs to be continued for the remaining blood transfusion flows. background: . million of germany's population, so just under a quarter of residents, have a migration background. the majority of these has roots in regions where the population has a distribution pattern of blood group and hla-antigens that differs considerably from the predominant one in the german population. sufficient supply of these individuals with red blood cell (rbc) and platelet concentrates (tc) will continue to be a major challenge in the future, as blood donors with compatible blood group antigens are dramatically underrepresented in the local donor pools. many migrants suffer from severe hematological disorders such as b-thalassemia or sickle cell disease and will not only need compatible blood transfusions, but an allogeneic stem cell transplantation in the foreseeable future. as healthy family donors often are not available, at present suitable stem cell donors with a similar genetic background can only be found in international donor registries. aims: this project was initiated to recruit new donors with a migration background for blood donation and to increase the number of blood stem cell donors among this group. methods: serological extended blood group phenotyping was performed by automated gel card technique (fa. grifols, erytra) and included ab , rh (ccdee), kk, fy (ab), jk(ab), lu(ab), m, n, s, s. hla typing for hla-a, -b, -c, -dr, -dq, and -dp was performed by next generation sequencing. allele frequencies were analysed using genepop version . ; the rare and very rare alleles were defined according to the allele frequency database (www.allelefrequencies.net) rbc genotyping using next generation sequencing is currently being established and will include additional antigens with the most frequent distribution pattern differences between migrant and resident populations according to literature. results: so far, more than blood donors with a migration background have been recruited for a blood donation in this project. amongst this group, over blood donors from more than non-european countries enrolled as potential stem cell donors. an initial evaluation of the data revealed a very similar distribution of blood groups compared to the current blood donor population in north rhine-westphalia. of migrant donors, ten fy(a-b-) donors were identified, which corresponds to a percentage of . %. amongst hla-typed potential stem cell donors, we found ( . %) with rare and very rare alleles. summary/conclusions: blood donors with rare blood group and hla phenotypes (e.g. null types such as fy(a-b-)), are in demand for adequate medical care of people with a migration background. the technological development of blood group determination by next generation sequencing will significantly improve the supply for all blood transfusion recipients in germany. this project is funded by the european development fund - (erdf) and the european union. background: mortality due to uncontrolled haemorrhage following trauma is the most important cause of potentially preventable deaths. trauma care systems in low and middle income countries like india, are still in developing phase. also, the role of blood component therapy in improving patient outcomes has been mostly derived from combat settings. application of these protocols in an urban setup has not been well established and marked variation in practice exists. hence this study aims to identify the key components of transfusion practices to optimize the transfusion protocol in trauma settings. aims: to study the current transfusion practices in severely injured trauma patients, admitted to the red area/resuscitation bay after initial triage in ed methods: this prospective observational study was conducted over a period of year starting from june to may at the department of transfusion medicine in collaboration with emergency department at jpnatc, aiims, new delhi. the study included severely injured patients (iss ≥ ) that were admitted within h to the red area/resuscitation bay after triage. data collected included the demographics, injury, laboratory and transfusion details for these patients results: during the study period patients ( . % males) were enrolled. mean iss scores was . . mean time to hospital admission after injury was : (iqr . - : ) hours. mean time to first rbc transfusion following admission was : (iqr : - : ) hours. approximately . % ( ) patients were in shock (sbp < mm hg &/or pulse rate > /min). whereas, ( . %) patients were coagulopathic (pt ≥ . times of normal). during initial h of admission, these patients were transfused with ( . %) rbc, ( . %) ffp, ( . %) rdp and ( . %) cryoprecipitate of total blood components utilized for these patients. massive transfusion (defined as transfusion of ≥ units/ h) was given to ( . %) patients. summary/conclusions: significant quantity of blood components were required during initial resuscitation in severely injured patients. pre-hospital transfusion can significantly reduce the time to transfusion. further studies are needed to assess utility of pre hospital transfusion in severely injured patients. background: allogenic stem cell transplantation recipients are known to be the main consumers of platelet concentrates (pc). the geneva university hospital is one of the three allogeneic hematopoietic stem cell transplantation (hsct) centers in switzerland. since the blood center is also part of the hospital, data of pc consumption are easily available. as needs rose steadily since several years, with an average increase of % per year, pc supply is a serious concern for our center. aims: in this study we tried to evaluate if any pre-transplant indicator could help to forecast the number of pc needed after an allogeneic hematopoietic stem cell transplantation. methods: this observational retrospective study was conducted in geneva hospital on patients suffering from various inherited or acquired disorders of the hematopoietic system who were treated by hsct in . pc consumption was examined from january to december . the five indicators were: gender, stem cell source (bone marrow (bm) vs peripheral blood stem cell (pbsc)), donor type (hla matched ( - / ) vs haploidentical), conditioning regimen (standard vs reduced intensity), and cmv serology of the recipient. results: data for a total of patients aged from to years were analyzed; ( %) were male and ( %) female; ( %) were cmv-negative and ( %) were cmv-positive. out of a total of transplants, ( . %) were haploidentical and ( . %) hla-matched. according to the stem cell source, bm was transplanted in cases ( . %), and pbsc in cases ( . %). two patients also received a cd + stem cell boost. our analysis showed that, with a mean follow-up of days, the number of pc transfused to our patients treated by hsct ranged from to units, with an average of and a median of , illustrating a high variability. the results indicated that gender, stem cell source (bm vs pbsc), conditioning regimen (standard vs reduced intensity), and cmv serology of the recipient do not have any statistical impact on platelet consumption. however, we observed a tendency of an increased need for platelet transfusion when patients were cmv positive. our results also showed a statistically significant (p = . ) higher number of pc transfused for patients treated with a haploidentical ( ) versus hla-matched ( ) transplant. summary/conclusions: this study points out the high variability of platelet consumption after hsct, which limits the forecast of platelet production needed to support allogeneic hsct recipients. a larger cohort would be required to confirm a potentially higher platelet consumption in cmv positive patients, and to consolidate our results showing a higher pc consumption for patients treated with haploidentical transplant. abstract withdrawn. background: historically at our institution, a minimum of four red blood cell (rbc) units were crossmatched for all cardiac surgery cases regardless of surgical case-type or patient characteristics. two rbc units were packed in validated blood product coolers and brought to the operating room (or); the balance of crossmatched units remained in the blood bank. a retrospective review revealed that very few rbcs were transfused ( : % ( / ), : % ( / )). moreover, approximately products were wasted each month as a direct result of this practice. thus, we recognized an opportunity to improve inventory management in terms of personnel activities and blood component utilization. aims: the goal of this study was to reduce advance preparation of coolers in cardiac surgery cases without compromising patient care and safety. we limited our intervention to those patients who were eligible for electronic crossmatch. we maintained the aforementioned historical practice for those patients with history of and/ or those who currently demonstrated clinically significant red blood cell alloantibodies. methods: a multidisciplinary group consisting of representatives from the blood bank, cardiac surgery, cardiac nursing, cardiac anesthesia and surgery quality department was assembled in october to determine whether a modification of practice was reasonable and safe. group members evaluated site specific society of thoracic surgery (sts) cardiac surgical data between july and december to establish intraoperative red cell transfusion rates classified by type and urgency of surgery. the group's main goal was to discontinue preparation of default coolers for patients eligible for electronic crossmatch who were scheduled for all types of non-emergency cardiac surgery cases in which ≤ % of historical cases required at least one red cell transfusion. additionally, team members simulated the multiple protocols by which red blood cells could be prepared and delivered to the or and estimated the time for each scenario. results: review of sts data showed that the following cases met the criteria of ≤ %: elective primary coronary artery bypass graft (cabg), urgent primary cabg, elective mitral valve repairs, and elective aortic valve replacements. simulation showed that, in patients eligible for electronic crossmatch, preparation from receipt of order to completion of unit packing for delivery took . min using the pneumatic tube system (maximum of units per tube) and . min using delivery of a cooler using a human courier. summary/conclusions: based on the simulation results, and with consensus agreement from the multidisciplinary group, default cooler preparation for elective primary cabg, urgent primary cabg, elective mvr, and elective avr was discontinued in december . one year following implementation of the change in policy rbc units were issued to the or (a % reduction); % ( ) were transfused, compared to % in . wastage rates decreased from products a month to per month on average. summary/conclusions: the most obvious drawback of pabd is the higher cost in running the program in comparison with collection of allogeneic blood in the areas of additional patient attention and clerical input in labeling, separate storage and so on. in this audit, % of the autologous blood components were not transfused into the intended recipients and wasted; in this context, the pabd program could not be considered as a cost-effective approach in protecting blood safety. background: the national blood service zimbabwe (nbsz)'s blood supply management status (bsms) is an integral process of ensuring the availability of a safe and sufficient blood supply provision. nbsz introduced a new daily blood bank statement with improved metrics from may . the new analytics approach focuses on three interactive components of the blood bank statement; the available stock, quarantine stock (as per the desired -days stocks level), and the demand versus supply. it is imperative to have a closely monitored blood supply chain because blood has limited shelf life with uncertainties in both supply and demand. the 'blood-for-free' proclamation by the government of zimbabwe in july set more pressure on the blood demand. these metric-based analytics seek to assess if the nbsz's improved blood bank statement is a realistic model for the bsms. aims: to assess the use of the interactive metrics in monitoring the blood supply management status. methods: a prospective cross-sectional study was conducted. a total of daily blood bank statements which were submitted between may and december from each of the five branches were analyzed. the bsms which is calculated as the average of the three interactive measures of quarantine stock, available stock and demand versus supply was determined. sub-analysis of branches was done to determine individual branch performance. analysis by month was done to assess seasonal variations. findings and recommendations were shared among key stakeholders to validate the bsms methodology. results: overall the quarantine stock average was . % (sd +/- . ), the available stock was . %: (sd +/- . ) and the demand versus supply was at . % (sd +/- . ).the overall bsms was . %; (sd +/- . ) for the study period. gweru and masvingo nearly supplied all the demanded blood with . %, overall bsms of . % and . %, overall bsms of . % respectively. bulawayo supplied . % of the blood demanded with an overall bsms of . %. mutare supplied . % with a bsms of . % and harare . % and a bsms of . %. there were monthly variations but the service could supply above % of the blood demand. in the month of may the service met . % of the demand and a bsms of . %. in november and december it supplied . %, bsms of . % and . %, bsms . % respectively. august also had a below average supply of %, bsms - . %. june, october and september recorded above the average values; . %, bsms of . % and . %, with a bsms of . % respectively. summary/conclusions: the overall bsms performance was satisfactory and it was noted that branches capacitated according to demand. the new interactive analytics approach is appropriate for showing the blood bank status and assessing the performance of the branches. this new approach has optimized the decision-making process in blood supply management. the metrics are tracked using excel based model hence this approach is suitable for resource constrained settings with limited ict infrastructure . st vincent's hospital melbourne (svhm), a tertiary hospital supporting medicine, surgery and non-major trauma emergency and itu services implemented a mtp in . subsequent mtp reassessment has led to implementation of regular multi-disciplinary review of all mts to identify areas for improvement in transfusion and other aspects of support for critically bleeding patients. aims: to implement a systematic service-wide stakeholder review of mt events at svhm aiming to identify deficiencies and implement improvements in mt management. methods: a multi-disciplinary mt review team was established as a subcommittee of the hospital transfusion committee (tc) to update the organisational mtp in and subsequently continued to meet quarterly as the mt review subcommittee (mtrs) of the tc, systematically reviewing all aspects of mts at svhm. instances where or more red cell units are transfused in < h are identified from the laboratory information system and reviewed by the mtrs which includes representatives from accident and emergency, intensive care, operating suite (os) and transfusion laboratory staff; the head of the patient's treating unit is also invited to contribute. reviews include: demographics, clinical details, comorbidities, time from patient arrival to pre-transfusion specimen collection/receipt, time from blood request to release/transfusion, regularity of full blood examination (fbe)/coagulation (coag) testing, timing of blood component transfusion, total component provision/ratios, component waste, patient outcome, and communication between various clinical areas and also the laboratory. a discussion summary with actions/ recommendations is provided to the tc and some cases referred to the hospital mortality/clinical review committee. results: cases reviewed: from treating units including cardiothoracic surgery ( ) hepatobiliary/gastrointestinal/colorectal surgery ( ), vascular surgery ( ), neurosurgery ( ), orthopaedic surgery ( ), endocrine ( ) and "other" (encompassing general surgery, urology, general medicine and oncology - ). areas for monitoring/improvement identified: transfusion documentation, regularity of fbe/coag specimen submission, reducing time between patient arrival and specimen collection, reducing specimen transport time, interfacing point of care bloodgas analysers to the central pathology result management system as well as component management/waste reduction and the introduction of viscoelastometry assessment in the os. of reviewed cases involved the transfusion of emergency uncrossmatched o rhd negative red cell units. the appropriateness of the use of this precious resource is also reviewed by the mtrs. summary/conclusions: the svhm mtrs meets regularly to review mt events and formalise multidisciplinary collaboration in identifying possible improvements to support these often critically ill patients. matters highlighted include communication issues, delays in specimen delivery and blood component waste minimisation. areas for further work include minimising delay between mt events and review, and formalisation of key performance indicators for mts. background: the use of radio frequency identification (rfid) technology to manage the blood supply chain is recognized as a major enhancement to the operations of blood banks and hospital transfusion services. to facilitate optimal blood supply management, it is crucial to guarantee the integrity of rfid tags throughout the transfusion chain. since rfid tags can be affixed to blood products very early in the process, these tags undergo the same process-steps as the blood products themselves (e.g. centrifugation, label printing, shock-freezing and irradiation). aims: the goal of this study was to validate the mechanical and functional resistance of biolog-id rfid tags through different blood related processes: centrifugation, label printing, shock-freezing, intensive reading at À °c, and irradiation. biolog-id tags are passive hf ( . mhz) tags. they are compliant with is , iso - and follow the guidelines for the use of rfid technology in transfusion medicine (vox sanguinis, ). methods: biolog-id tags were evaluated using a series of rfid encoding and reading tests. before each of the processing steps, each tag was encoded with donation number, site id, product code, blood group and expiry date. the data was encoded using the isbt format. the different processing steps and conditions tested were: -centrifugation: quintuple whole blood bags, filled with ml water. centrifugation at , rpm for min. tags processed, tags per kit affixed at different positions. -shock-freezing at À °c: shock-freezer (angelantoni, sf ), units processed, reading immediately after removal from shock freezer. water, tags irradiated at gy and tags at gy results: all biolog-id tags were encoded and read with a % success rate in all series of tests. summary/conclusions: biolog-id rfid tags can be encoded and read through common processes used throughout the blood transfusion chain. their mechanical and functional integrity is not affected by centrifugation, shock-freezing, intensive reading at À °c, printing, eto sterilization and irradiation. background: the provisioning of compatible red blood cells by international cooperation is presented. the units were meant for an -year old female, with homozygous sickle cell disease (scd) and multiple complications. patients' blood group was a positive with anti-c, -e, -wr a and an antibody to a high prevalence antigen in the rh system, anti-hr b possibly combined with anti-hr b (rh ). the antibody was not reactive with rh null , -d-or hr b negative cells. the donor center put out an international request for group a or o, rh null or -d-units lacking wr a and possibly k, fy a , jk a , wr a , do a and s (the latter antigens for prophylactic matching). the patient sample had been genotyped for rhd and rhce using mlpa and sanger sequencing and the patient was found to carry rhd* /rhd* n. and rhce*cevs. / rhce*cevs. . aims: the request was sent to the american rare donor program (ardp). the ardp working with the american red cross national molecular laboratory, used the rh genotype information to identify donors carrying the same or similar rh variant alleles using the rh allele matching approach described previously (keller et al. transfusion ( s): a). methods: a recent blood sample was used to confirm anti-hr b ; no anti-hr b was detected. the patient rhd and rhce alleles were used to build punnett squares for both genes with donors carrying the same and similar alleles that would be predicted to be compatible. tier donors are those predicted to carry the same combination of rhd and rhce alleles as the patient. tier donors are those predicted to be homozygous for one of the allele combinations carried by the patient. tier donors are those predicted to carry alleles similar (but not identical) to those carried by the patient, with similar predicted phenotype. the database of donors in the ardp carrying rh variant alleles was queried against the alleles in the patient-specific punnett square. results: donors of group a or o and matched for rh alleles were identified as follows: tier , tier and tier donors. after the clinical team agreed to drop one or more of the prophylactic antigen matches, one tier unit lacking s and jk a was identified at the american red cross. while the request was being processed, the patient experienced a sickle cell crisis, red cell aplasia and recurrent aiha and her hemoglobin level dropped from to . g/dl. at that time, she was transfused the only compatible units available - of the rare -dphenotype and her hb increased to . g/dl and eventually to g/dl. the tier rh allele matched unit was shipped to amsterdam where it was frozen, and reserved for the transfusion care of this patient. summary/conclusions: this case illustrates how rh allele matched blood can be found for a highly rh alloimmunized patient, and can avoid use of the exquisitely rare -d-or rh null blood. background: blood transfusion has been a complicated and high-risky clinical procedure. any error could cause serious injuries to patients. to better assure the procedure safety. aims: we enhanced and built a blood transfusion database platform and develop inventory management strategies to better guarantee the patient transfusion safety. methods: we designed six new features of the platform ( ) assuring the patient identification with barcode techniques; ( ) designing a structured order entry; ( ) proactively reminding the physicians with patient's previous blood transfusion reaction with related precautions including the use of leukoreduction filter; ( ) automatically reminding physicians the happening of reaction and suggesting relevant test; ( ) building a complete traceability log system; and ( ) supporting data analysis. the blood transfusion safety team includes medical technologists, nurses, physicians, system analysts, and blood transporter and the whole process is electronic management. the new blood transfusion platform integrated the workflow, reduced the incidence of abnormal blood samples collected ( % after implementation, p < . ), reduced the time of call for medical technologists with blood component preparation and improved the achievement rate of emergency -min blood crossmatch ( . % after implementation, p < . ). the barcode correctly identified patients and monitored the entire transfusion process to reduce the error rate of blood component supply ( % after implementation, p < . ). summary/conclusions: after the transdisciplinary team approach with e-monitoring and a better design of clinical decision support module with barcode technology, blood transfusion database platform improve the blood supply efficiency and assure blood transfusion safety. background: in the modern world, terrorist acts are characterized by a multiplicity of combined injuries to a large number of victims. qualified medical care is urgently required for a large number of patients in one locality at the same time. it leads to increase in emergency demand for blood components, mostly red blood cells. the desire to donate blood to the victims is a natural manifestation of society's solidarity in response to tragic events. however, donor activity and patient needs do not always correlate. aims: to analyze the donor activity during the terrorist attacks. methods: a retrospective analysis of donation activity in periods of terrorist attacks in moscow ( moscow ( - . the average daily blood donations' number (dbdn) before ta compared with the number of donations in day after ta and with the dbdn during days after ta. also the number of delivered rbc units (d-rbcu) daily before ta and daily in days after were compared. results: in - , terrible ta occurred in moscow: people died and more than were injured. with the explosion in subway in / people died, were injured. the number of d-rbcus increased by % on ta-day, and by % during next days. dbdn in the st day after ta increased , times, and in the next days - , times. second explosion in subway in / resulted in died, injured. the number of d-rbcus increased by % on ta-day, and by % during days. dbdn in the st day after ta increased , times, and in the next days - , times. in (explosion on market) resulted in died, injured. d-rbcus delivery increased by % on ta-day, and by % during days. dbdn in the st day increased , times, but decreased to , times during the next week. with subway explosion in people died, were injured. the number of d-rbcus increased by % on ta-day, and by % during days. dbdn in the st day after ta increased , times, and in the next days - , times. with the explosion in airport in people died, were injured. rbcus delivery increased by % on ta-day, and by % during next days. dbdn in the st day after ta increased , times, and in the next days - , times. summary/conclusions: an increase in donor activity is observed already the next day after ta and usually lasts for days, but does not correlate with the number of victims. the rbcs' delivery from blood bank increases in all cases on the day of the ta. therefore, the guarantee for patients is the maintenance of rbcs' stock, including cryopreserved ones. it is also necessary to promptly send excess of red blood cells harvested at the peak of activity to the cryobank. background: rh system is the major blood group system besides abo system. even after proper blood grouping and cross matching there is a possibility of alloimmunisation in recipients against the rh or minor blood group antigens like kell, mnss, duffy etc. in medical colleges which cannot bear the financial burden of complete phenotyping of patient and donor, implementation of rh & kell phenotypes match blood transfusion can play a major role in preventing alloimmunisation and adverse events in multitransfusion patients aims: to evaluate the efficacy of rh & kell phenotyping as a cost effective measure instead of extended phenotyping in multitransfused patients methods: study was carried out in the department of transfusion medicine, one of the biggest blood bank of the country with annual collection of , blood units. patients of thalassemia, aplastic anemia and leukemia were taken who required multiple transfusions. complete phenotyping was done initially of all the patients before transfusion. patients were taken as control and the other were taken as cases. blood units of healthy donors were chosen ( were males and were females). in all the donor units, identification of rh & kell phenotyping was done by the antigen antibody agglutination test by the erythrocyte magnetize technology on fully automated immunohaematology analyzer qwalys. these blood units were transfused to patients who had been selected as cases. in the control group, patients were transfused blood units which were not phenotyped for rh & kell but gel crossmatching was done. follow-up was done on these patients for transfusion reactions and at the end of six months they were evaluated for any alloimmunisation. results: at the end of months, no reactions were reported in cases receiving rh & kell phenotype blood and no alloimmunisation was seen on repeat phenotyping. the control group on the other hand reported reactions in cases ( . %) and phenotype at the end of three months showed alloimmunisation with 'e' antibody. the phenotypic frequencies of rh & kell blood groups in the population were comparable with other published studies. amongst the rh antigens (e) was the most common ( . %) followed by d ( . %), c ( . %), c ( . %) and e ( . %). thus 'e' was the most common and e was the least common of all the rh types. background: the prevalence of a particular blood group has an uneven distribution in different geographic areas and is largely determined by the national composition of the population. moscow is one of the largest city of europe with population of . million. the understanding of prevalence of red blood cells antigens (rbc-ag) among the population has great importance for blood banking planning. aims: to determine frequency and distribution patterns of transfusion-significant rbc-ag among donors in the moscow region. methods: the results of immunohematological studies on ab , rhesus and kell systems were analyzed retrospectively in blood donors for years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) in moscow. data collection and processing was carried out using the regional information system for transfusiology. rbc-ag detection (ab , rh, kell) systems was performed using microplate method (automatic immunohematological analyzer "galileo neo" (immucor, inc., usa)) and "ih- " (bio-rad laboratories, usa) with diagnostic cards. results: the most frequent blood group is a (ii) . %, (i) blood group . %, b (iii) . %, ab (iv) . % (n = ). rh(d+) was established as positive in the presence of antigen d and as rh(d-) negative in its absence. donors with weak variants of antigen d (du) were determined as rh (d+) positive. the ratio of rh (d+) and rh (d-) was . % and . %, respectively. donor's phenotype detection was routinely conducted from the year, therefore the number of donors was . the most common phenotype among donors ccdee ( . %), the second in frequency ccdee ( . %), the third in frequency rhesus negative phenotype ccddee ( . %) in the studied population. the ccdee and ccdee phenotypes were . % and . %, respectively. the most rare are ccdee ( . %), ccdee ( . %), ccddee ( . %). other options: ccddee, ccdee, ccdee, ccddee, ccddee, ccdee, ccddee were detected in single cases and amounted to a total of . % (n = ). cw antigen was tested in donors and was detected in . %. cw is most commonly found in donors with ccddee phenotypes ( . %), ccdee ( . %) and ccdee ( . %), with other variants of the data phenotype, the antigen was detected in . % of the examined (n = ). antigen k was detected in . % of donors, in . % of this antigen is absent (n = ). summary/conclusions: the study of transfusion-relevant antigens distribution in population is necessary for building of effective and flexible model for blood service managing. a differentiated approach in choosing a strategy to form a long-term bank for storing blood components, taking into account the frequency of various antigen variants, contributes to improving the quality, accessibility and safety of medical care. of dislocated division of our blood establishment in orthopaedic hospital valdoltra (obv) in the number of outdated units at the hospital side dropped considerably. results: since when the issued number of red blood cell units (rbc) was the amount of issued units rose to in and then dropped more or less steadily to in . in this period the hospitals' programmes rose for % in all areas. number of donated units declined from in to in . after reorganization in the number of outdated units fell from % of stocked units to . %. after setting a dislocated unit of ctdiz on obv location the number of discarded rbc fell from to in . for transfusion specialist who is constantly in contact with the clinician in the hospital the most important day routine is when the stock availability is displayed. it happens times a day; at a.m. when the previews' day collection is released and another three times a day when the updates occur. the central base is led in ljubljana (the capital) and all centres are able to control and order the stock for the blood banking. blood wastage remained low and the traceability of the blood usage in south-western region remains high ( %). though it is not supported by an informational system the traceability form the blood bank to the patient is done on paper. this issue demands a big effort by the staff in blood bank and in hospitals. summary/conclusions: reorganization enabled better stock utilization and traceability of issued units. sometimes it is impossible to predict the peak demand of rbc especially during the summer season when the population of the area doubles and car accidents as well. transfusion specialist's effort in assuring the optimal blood stock represents the crucial daily routine. blood bank, grande international hospital, kathmandu, nepal background: voluntary non-remunerated blood donor consists of % blood donor's population in nepal. therefore demographic about the distribution of blood donors according to the age group is important to achieve % voluntary nonremunerated blood donors in nepal. aims: to explore the demographic distribution of the blood donor in different age group in the kathmandu nepal. methods: this is retrospective study conducted at nepal red cross society central blood transfusion service. data from january to january were collected from donor management software. the data includes socio demographic data. data has been process with spss version - results: during years study period, total of , blood donation happened from both mobile blood collection and in-house blood collection. out of , collection, ( . %) are from - age group; ( . %) are from - age group ( . %) are from - age group; ( . %) are from group - age group; ( . %) are from age group - and ( . %) from age group above respectively. summary/conclusions: the distribution of abo blood group varies regionally and from one population to another. in kathmandu, nepal - years age group is the most common age group encountered donating blood. the data generated in the present study and several other studies of different geographical region of india will be useful to health planners and future health challenges in the region. background: the information system on hemovigilance sihevi-ins©, coordinated by the national health institute was available in to all blood banks in the country. this software allows to centralize and record the identification data of a donor, its infectious and immunohematological tests, as well as the fractionation and final destination of each blood component obtained from a donor. aims: to describe the abo and rhd typing discrepancies in blood donors found in the blood group variables registered by each blood bank to sihevi-ins©. methods: retrospective analysis of the information registered by of the blood banks authorized nationwide between january and december . results: sihevi-ins© received information of , accepted donors, % of them with more than one donation in the same blood bank in a period of months. a total of abo or rhd discrepancies were identified in people, who made donations in blood banks (estimated risk: one discrepancy per , accepted donors). five of the blood banks implicated in these discrepancies are hospital-based (annual average collection of , ae , units, representing . % of the national collect). the remaining blood banks are distributors (average collection: , ae , units per year, representing % of the national collect). % of blood group typing discrepancies (n = ) were related to the abo group. the most common discrepancy was between a typing group and ab typing group ( %) . in % of the cases, the same blood bank initially registered in the same donor, an o blood type donation and later an a blood type (n = ) or b type (n = ). rhd typing discrepancies account for % (n = ) of the total. additionally, in three donors, a simultaneous discrepancy between abo and rhd typing was detected in the same blood bank. the results could be due to: a) failure in the warning mechanism before the release of the blood component; b) errors in typing the information of the donor registered in the system or c) failures in the identification of the donors at the time of selection. the above shows risk in the process of control of blood components release, which can impact patient safety unless abo and rhd typing blood groups are systematically verified before transfusion. summary/conclusions: despite blood banks have a verification and validation process through software to release blood components, flaws were detected. although sihevi-ins© is not a software to validate the information before the release of blood components, it was through this program that abo and rhd typing discrepancies were identified in donors who attended the same blood bank multiple times. this finding implies increasing the controls that should be used in each blood bank, to avoid lose traceability of the processes and to put at risk the life of the recipients. blood donor testing department, blood transfusion institute of nis, nis, serbia background: the ability to automate blood grouping and antibody detection procedures is a requirement for blood donor testing laboratories. mistakes in the sample identification and testing procedures could be prevented by testing on automated immuno-hematology systems. irregular antibody screening and abo/rhd grouping of blood donors are tests performed routinely in blood transfusion institute of nis. neo iris (immucor, usa) is a fully automated instrument for the abo and rh d grouping using microplate hemagglutination technique and antibody screening and identification using solid phase red cell adherence (sprca). aims: evaluation of the automated neo iris system for abo and d grouping and irregular antibody screening of blood donors in blood transfusion institute of nis. methods: during the evaluation period a total of edta-anticoagulated samples for abo and d forward and reverse grouping using microplate anti-s, anti-s, anti-jka and anti-k. in one case ih- failed to identify anti-c antibody in very low titer in sample with anti c+d antibody presence. in two samples ( . %) false-positive result were observed both on ih- system and neo iris and in two cases ( . %)only on neo iris due to nonspecific reasons. summary/conclusions: abo/rhd grouping results obtained on neo iris system, using microplate method, have a good correlation with results on ih- system as our routine column agglutination method. for antibody screening and identification neo iris showed high sensitivity for detection of clinically significant antibodies which is important step for increasing blood transfusion safety. background: continuing improvement of laboratory quality to provide accuracy test results for precise diagnosis and treatment is the mission of advanced laboratory. immunogenetic testing for histocompatibility including human leukocyte antigen (hla) typing, hla antibody detection and cytotoxicity test is critical for diagnosis and evaluation of transplantation and prognosis monitoring. in order to improve the quality of experiment competency, an external quality assurance schemes with review and education per year program was established and performed during the period from to in taiwan. aims: the proficiency testing (pt) held semiannually from to were reviewed to investigate the outcome of competency improvement of laboratories participated in the program. methods: the test items in the exercises were classified into groups, hla genotyping (including pharmacogenetics hla typing), cytotoxicity test, hla and platelet antibody. the methods of hla genotyping include ssp (sequence specific primer), sso (sequence specific oligonucleotide), sbt (sequence based typing) and either ssp+sso or ssp+sbt were used, the methods of hla antibody including elisa, flow cytometry and luminex were used and the methods of platelet antibody including sprca and elisa were used. there are four shipments of exercise materials in two years and each shipment include two positive and one negative samples for antibody detection, two each of whole blood and serum for cytotoxicity of t and b cell and three whole blood for hla genotyping. aims: this study aims to survey transfusion related laboratory tests for the quality improvement of hospital's blood bank management. methods: we analyzed survey results of kinds of routine work categories of blood banks that were registered on korean association of external quality assessment service. blood bank worker voluntarily replied this electronic survey. the categories were as follows: . characteristics of institution . the equipment of blood bank . the kinds of tube in blood bank . the present kinds of blood bank tests . abo and rh type tests . the cross-match tests . the irregular antibody tests . hemovigilance system . other blood bank tests . massive transfusion protocol . quality control issues we analyzed and compared each category data according to considering characteristics of hospitals. results: there were consensus and some differences of current blood bank tests. we presents the result of a pilot survey. especially the cross-match tests were divided by saline phase method added with irregular antibody tests or completion of rd step anti-human globulin phase according to institutional environment. automated typing machines or automated irregular antibody test devices were more increased in large-scale hospitals than small-scale hospitals. different kinds of tubes were used such as edta tube for abo and rh typing, plain tube for cross-match test. the retention segments of rbc were reserved for minimum days. most blood bank were registered and regularly listed up transfusion events to korean hemovigilance system for safety transfusion. also, a lot of institution have none or underdeveloped massive transfusion protocol. more specific survey results will be analyzed in further poster presentation. summary/conclusions: this survey will show the current status of transfusion related blood bank test. this institutional blood bank comparison will be helpful to assess the currency of individual blood bank environments. abstract withdrawn. background: we know that quality management is a continuous process, involving implementation, maintenance and improvement. aims: our purpose is to show our experience in implementing the quality management system in the whole institution and our first steps in achieving the jacie accreditation in the stem cell collection facility in order to provide our patients and donors the best possible care. methods: the institute for transfusion medicine of the republic of macedonia (itm) is the main institution in charge of blood transfusion service (bts) in the whole country, which is the national unified system. the stem cell collection facility is a part of the itm. this facility is operational since year with collections of stem cells ( in patients and collections in sibling donors) till now. we are obtaining the implementation and maintenance of qms through the establishing of the iso standardization for the whole institution (itm), as well as of implementing jacie standards in the stem cell collection facility. the two of our colleagues became the jacie inspectors and the standard operating procedures (sops) were developed, followed by regular meetings, trainings and self-evaluation of the personnel. we asked for the orientation visit from the independent jacie inspector in order to come one step closer to the jacie accreditation and to improve our overall qms. results: the institute for transfusion medicine of rm was a part of the ipa project "strengthening the blood supply system". this project aimed to ultimately bring the blood transfusion service to european union standards allowing the exchange of blood components and all other types of collaboration with other european union countries in future. the project put the basis for unification of blood transfusion standards and operating procedures in the whole country as well as set up essential education of blood transfusion personnel. although a lot of strengths were found during the orientation visit from jacie inspector, there are still a lot of areas for improvement. our strengths are motivated team and supportive institutional leadership including macedonian ministry of health. areas for improvement are: labeling of cellular therapy products and lack of laboratory for quality control. there is a national regulatory framework in place and who and world bank initiatives in macedonia which support quality in health care and accreditation. summary/conclusions: our institution has in plan to implement isbt standards for labeling of cellular therapy products and to establish a laboratory for quality control of cellular therapy, as well as to meet all the requirements to become jacie accredited facility. working by standards, following the rules and regular self-evaluations will help us to maintain the strong quality management system. every institution will benefit from a quality management system that brings you into line with international standards. ensuring the quality of our services and products is essential to keep safe and strong blood transfusion service. background: implementation of robust quality assurance program is key to high performing blood establishments. quality control and quality assurance systems together constitute the key quality systems and are parts of quality management. effective and efficient quality control policies not only provide guidance that help to increase the reliability of results but also maintains the laboratory's consistence performance overtime. aims: therefore, we established a set of qc limit using historical data which can timely identify unexpected variation in the testing systems and trigger a review of test processes in blood screening laboratories as part of quality assurance system. methods: last two consecutive years (jan, to dec, ) qc data from archi-tect i sr (abbott laboratories, chicago) was extracted using abbottlink for philippines red cross tower national blood center total of data points ( data points in & data points in ) were obtained for different qc levels for four serological blood screening assays (hiv combo, hbsag, anti-hcv, syphilis). the data was sorted for each assay/lot and qc level combination by year. qc limits were calculated using simple mean, standard deviation (sd) and coefficient of variation (cv%) and were validated and compared with manufacturer's recommendation. results: all the six positive quality control levels cv% ( . - . ) were within manufacturer's precision recommendation (within lab precision hbsag ≤ %, anti-hcv ≤ %, syphilis ≤ %, hiv ≤ %) in . five out of six positive quality control levels cv% ( . - . ) showed within manufacturer's precision recommendation (within lab precision hbsag ≤ %, anti-hcv ≤ %, syphilis ≤ %, hiv ≤ %) in except syphilis tp positive control ( . %). all four negative quality control levels showed the sd values within . - . in and . - . in respectively. summary/conclusions: excellent qc performance was observed in philippines red cross tower national blood center blood screening laboratory based on historical data and evidence-based laboratory qc limit for blood screening assays were established using historical data which takes into account total variation expected in a test system and offers a more robust and meaningful mechanism for setting control limits, for the first time. background: quality indicators (qi) in transfusion medicine (tm) are 'critically important aspects of transfusion medicine practice that are measured and utilized to gain insight for continuous quality improvement, into the degree to which the tm is capable of providing quality tm care, products or services for the aspect of practice measured following comparison of the measurement against acceptable local or international reference thresholds, benchmarks, standards, or practice guidelines'. the critical control point (ccp) selected for this study is 'administration techniques and monitoring of key elements'. this has been selected since the clinical fraternity plays a larger role in ensuring quality services in administration of blood components. there was a need to follow up compliance to standard protocol for bedside transfusion practices hence was decided to study the same with four selected quality indicators and introduce corrective measures if necessary. aims: . to assess the existing transfusion practices in the institute with specific quality indicators . to introduce corrective reforms to improve the existing practice . to assess the transfusion practices after interventions using the same quality indicators methods: to assess the existing transfusion practices in our centre, transfusions were prospectively followed up with a structured checklist. the quality indicators used were (i) verification of blood components prior to transfusion (ii)initiation of transfusion within min of release from the blood bank (iii) close observation of transfusions for the first min (iv)completion of transfusion within the right time frame for each component. as a corrective measure, a transfusion monitoring format was designed which was distributed in every ward and the nursing officers were informed to monitor and document transfusions using that. in addition, the blood bank staff was made to call up the wards and ensure that the transfusions of every component had been initiated within min of issue. transfusion practices were once again monitored by following up transfusions using the same quality indicators. results: there was significant difference in all the four variables between the two phases. . % transfusions were verified in phase i while . % were verified in phase ii (p < . ). . % transfusions were started within half an hour of issue while in the second phase, it rose to . % (p < . ). . % transfusions were observed in the first min in phase i and . % were observed in the second phase (p < . ). in phase i, . % transfusions were completed within right time while the same in phase ii was . % (p < . ). summary/conclusions: we recommend the following as quality indicators for bedside transfusion practices: background: antibody titration consists in performing antibody detection with selected red cells of different sample dilutions. the titer is reported as the reciprocal of the highest dilution that induces macroscopic agglutination. the usual applications of titration are prenatal studies and complex antibodies identification. some publications have demonstrated that more variation in antibody titer and titration score are noted upon repeat testing of the same sample when testing was performed in tubes as compared to repeat testing in gel. aims: to evaluate the efficacy of automated antibody titration versus manual method by using gel microcolumn technology. methods: edta-anticoagulated whole blood donors' and plasma frozen samples containing a known irregular (rh, kidd, duffy, mns, etc.) and regular (a & b) antibodies were selected. the titers of samples were determined in parallel by using grifols analyzers (erytra and erytra eflexis) and compared versus grifols gel manual method by using grifols gel microcolumn technology and grifols red blood cell reagents. sixty of these also processed in parallel in erytra and erytra eflexis analyzers for comparison. for the precision study, of these samples were tested in the automated systems for times ( datapoints for each analyzer) on different testing days. the hands-on (manual intervention) average time required to complete a titration was measured ( expert technicians) in different sample workload ( and samples testing). these results were compared with the same number of independent titrations performed in grifols analyzers. for the walk-away time, different sample workload ( and samples testing) were assessed in manual method ( expert technicians) and compared to timings obtained when reproduced in grifols analyzers. results provided by analyzers were reviewed and compared to manual method. results: titer obtained by erytra or erytra eflexis was equivalent to the titer obtained manually (differences ≤ titer: % ≤ . titer). the results proved that both instruments were equivalent in performing titration (differences ≤ titer; % ≤ . titer). the precision results showed no difference between titers obtained through the % of the runs performed with the grifols analyzers (differences ≤ titer: % ≤ . titer). the manual hands-on in automated system was reduced in a % compared to manual method for sample. when the number of samples was increased ( samples), the difference in hands-on in was even more reduced ( %). in addition, the walk-away was % higher in automated system compared to manual method. furthermore, when the number of samples was increased ( samples), the walk-away difference was increased even more ( %). finally, automated system software demonstrated to increase the standardization of the test as all samples, results and reagents traceability were automatically managed. summary/conclusions: grifols gel system including erytra and erytra eflexis analyzers provided a scalable and efficient solution to perform standardized titrations in the immunohematology lab. the study proved that using grifols gel system, titrations can be run in an automated reliable way (less than one-fold differences versus manual gel), thus reducing at least % the hands-on, increasing at least % the walk-away, rising the standardization and automating all testing traceability. , and fourth case of use (results) scenarios, tasks were considered "very easy" by %> % of users and "easy" and by - % of users; %> % of the users considered "sufficient" the design to ease the interaction; and %> % of users never founding any situation of not knowing how to proceed. for the fifth case of use (user roles), % of users considered tasks "very easy" or "easy"; % of users considered "sufficient" the design to ease the interaction; and % of users never found any situation of not knowing how to proceed. for the sixth case of use (maintenance plan), % of users considered tasks considered "very easy" or "easy"; % of users never found any situation of not knowing how to proceed; and % of users considered the maintenance plan similar or better than other instruments. reliability analysis ( background: quality control procedures in blood group serology for reagents, techniques, personnel working and automated equipment are essential for the accuracy of the laboratory results. the observation of high number of uninterpreted results during blood donor grouping was a motive for investigation and possible targeting the problem. aims: to identify blood group interpretation problems by analyzing the testing results obtained with the commercial quality control samples routinely used during blood grouping. methods: a microplate (mp) system for performing abo and rhd, as well as rh phenotype and kell blood group determination with two automated analyzers techno ( and ) and correspondent two mp-readers lyra ( and ) using maestro software from diamed is currently in use for blood donor typing. three types of mp are being used such as: a, b, ab, dvi-, dvi+, ctl/a , b profile for first time donors, then a, b, d ctl for repeat donors and finally, the c, c, e, e, k, ctl profile. the accuracy and safety of the blood grouping results is ensured by using the diamed q.c. system which consists of + tubes of whole blood and tubes containing serum with known specific antibodies. we analyzed and compared the interpretation of the q.c. whole blood samples' results from both of the analyzers after a new optic camera was installed on the techno /lyra system. ward to ward. methods: a prospective observational pilot study was done for around prbc unit issues which were followed in real time for understanding the tat within blood bank & from ward to ward. as per the definitions, the areas where the times are documented perfectly are understood and considered for calculations. based on the conclusions of pilot study a monitoring form has been designed and utilised to monitor the tat within bb & wtw. the data is analysed monthly and an avg tat for bb & wtw is calculated. the common causes of delay in providing the blood components were analysed and strengthened to both reduce & control the tat. results: in pilot study, total wtw tat averaged to min, with highest time taken min, where there were additional processings like leukodepletion, irradiation, saline washing of red cells and holding the transfusion. lowest wtw tat was found to be min where there was a prior information for crossmatch. after the surveillance form has been started, the average time taken for wtw tat came down to min, maximum being min (jan ), the areas where delay happened were identified as internal courier delays, technician delays, billing & other logistics delay. the concerned staff are put on regular training to maintain the tat. summary/conclusions: although ethically all the staff work for providing better care for patients, there will be few areas that delay the life supporting blood transfusion. monitoring using tat surveillance forms help in avoiding the delays and hence provide better & timely transfusion support. blood donation -blood donor recruitment p- hematological and physiological characteristics of regular blood donors with beta-thalassemia traits background: according to recent evidence, the physiological variability observed in the hematological characteristics of regular blood donors (linked -in certain caseswith genetic factors or the donor's lifestyle) may affect red blood cell (rbc) storage lesion. beta-thalassemia heterozygous (b-thal-het) blood donors represent a group of particular interest because of a) the high frequency of thalassemia mutations in specific geographical areas b) the physiology of the b-thal-het rbcs, which predisposes towards more effective management of storage-associated stress. aims: the goal of the present study was the comparative examination of the hematological and rbc physiological features of regular blood donors with or without beta-thalassemia traits before blood processing for transfusion purposes. methods: healthy blood donors of greek origin ( - years old), who met the blood donation criteria were recruited in this study. plasma/serum (uric acid, electrolytes, extracellular hemoglobin, antioxidant capacity), cellular (rbc indices) and biological parameters (corpuscular fragility, proteasomal activity etc) were measured. the results were statistically analyzed and topologically represented in biological networks for both donor groups (+/-b-thal-het). significance was accepted at p < . . results: b-thal-het represented % of the donor cohort. no differences in lifestyle (smoking, alcohol consumption, physical exercise) were observed between the two groups. nevertheless, regardless of sex and sex-dependent parameters (e.g. hct, hb concentration), b-thal-het demonstrated: a) reduced hct, mcv and mch ( % p = . , % p = . and % p = . , respectively) and b) increased rbc count ( %, p = . ) compared to the average donors. moreover, mpv platelet index was found slightly elevated (p = . ) and serum total protein concentration slightly reduced (p = . ) in the same group. a trend for higher plasma antioxidant capacity (p = . ) was evident in the group of b-thal-het, in addition to statistically significant lower levels of osmotic fragility (by %, p = . ) and hemolysis (by %, p = . ) compared to controls. finally, analysis of the three proteasome-associated enzymatic activities (n = per group) in the rbc cytosol and the membrane, revealed similar levels in the two groups (p > . ). the b-thalhet and control biological networks showed insignificant variations in respect to the amount of connections and their hub profiles. however, differences were observed regarding the number or type of connections, or even their topology in the network, in the cluster of lipids (triglycerides, ldl etc), nitric oxide, clusterin, carbonylated plasma proteins and rbc osmotic fragility (correlated with the concentration of electrolytes selectively in b-thal-het donors) between the two groups. summary/conclusions: b-thal-het who meet the criteria for blood donation are a non-negligible sub-group of the total donor population in greece. they exhibit several similarities to the general cohort, but differ in fine characteristics of rbc physiology, including resistance to hemolysis and extracellular antioxidant capacity. the differential network profile of hematological and redox parameters may be important in respect to the subsequent blood processing and storage of b-thal-het erythrocytes for transfusion purposes. background: blood service in poland is based on voluntary and non-remunerated donations. regional blood donor centre in poznan as well as other regional centres (total of ) are the only entities authorized to collect, process, store and distribute blood and its components to hospitals in the region of their activity but they are also responsible to provide sufficient amounts of blood and its components. regional blood donor centre in poznan is one of the largest blood centers in poland with the total number of donations exceeding , per year. in the recent years we have observed a growing popularity of tattoos among various age groups as well as among people registering to donate blood (first time and repeat donors) hence, it is critical to introduce suitable measures to ensure the safety of blood and its components. aims: the aim was to analyse the correlation between the increasing number of donors deferred from donating blood due to having tattoos made and the number of recorded confirmed hcv infections and the effect it may have on the safety of blood and its components. methods: the analysis was made using the data for the years - obtained from the computer system 'blood bank' which is in operation in regional blood centre in poznan, poland. we have analysed the total number of deferrals of donors due to recently acquired tattoo and the total number of recorded confirmed hepatitis c infections. we must note that the category of temporary deferrals due to tattoos is a broad one: it includes so called regular 'artistic' tattoos, permanent make-up procedures as well as medical tattoos. results: we have recorded a significant increase in number of deferrals due to tattoos from in to in (+ %). in the group of male donors this trend remained rather stable with a slight decrease: from in to in (À . %). in the group of female donors the growth was more prominent: from in to in (+ %). in terms of the recorded confirmed hcv infections a downward trend can be observed: from in to in (À . %). in the group of male donors from in to in (À %), in the group of female donors from in to in (À %). summary/conclusions: as we can conclude from the analysis the applied policy of temporary deferrals of donors with recently acquired tattoos (in the last months) proves to be a reliable method of increasing the safety of blood and its components. nevertheless, the current conduct of the qualification of the donors which requires a month deferral following the new tattoo must be complemented by various and numerous educational activities regarding the means of hcv transmission (and other bloodborne viruses such as hbv, hiv) and ways of protection from possible infections. special emphasis must be put on the group of female donors as the growth of deferrals was more prominent among them. at the same time it is vital to ensure for constant availability for all donors of well designed, concise educational materials (hard copies on the premises, articles, infographics, downloadables etc. on the website). background: a temporary deferral has a negative impact on donor retention, with many donors failing to return at the end of their deferral period. anecdotal evidence collected by the australian red cross blood service suggested that many donors do not know when they are eligible to return to donate, suggesting that a reminder message may be effective at promoting donor return once the deferral has ended. aims: the aim of this study is to evaluate the effectiveness of a reminder message on the return rates of deferred donors at the end of their deferral period. this reminder message notified donors that their deferral period was ending and encouraged them to make an appointment to donate. this study also aimed to determine the most effective time to send the message, message content, and mode of communication (sms vs email) in optimising donor retention post deferral. methods: three separate randomised controlled trials were conducted to answer these questions. data on donors' attempted return behaviour and subsequent deferrals, appointments and donations made one month after the deferral end date were collected and analysed. results: overall, . % of donors who received a reminder message attempted to return compared to . % of donors in the control group (p < . ). looking at each time point, donors who received the message week before their deferral ended were % more likely to attempt to return compared to the control group (p < . ). the week prior reminder message was particularly effective with males, with . % attempting to return to donate, compared with . % of females (p < . ). there were no significant differences in the return rates of donors who received the recipient versus non-recipient focused message, or donors who received the message via email or sms. summary/conclusions: a reminder message sent to deferred donors at the end of their deferral period is a simple, cost-effective way to promote donor retention, providing clear information regarding the date on which the donors can return to donate as well as a prompt to make an appointment background: our challenge is to provide % voluntary donation for safe blood, thus taking into account the current history of family donation, promotion of blood donation, level of awareness and voluntary donations from various institutions, the opinion of interviewees will give us a clearer idea of what we want to achieve and what needs to be improved in the future. aims: . provide % voluntary donation for safe blood. . establishing a special department within the national blood transfusion center responsible for marketing and promotion of voluntary blood donation. methods: this study was conducted as a combination of qualitative and quantitative methods. the study was a combination and identification of existing data, direct interviews with persons of different age groups, preparation and dissemination of questionnaires and analytical processing of the collected information. the study questionnaire with questions in total was divided into sections out of which questions on blood practices were answered by all interviewees. people answered questions on the blood transfusion service. questions on blood knowledge were answered by people. questions on the knowledge of the blood transfusion were answered by people, questions on blood donation were answered by people and questions on the communication channels were answered by people. results: out of interviewees, % have never donated and did not intend to donate, due to the fact that most of them were afraid of needles and infections, while the smallest part didn't donate blood because it was not allowed by the religion, % did not donate, but expressed the readiness to donate in the future, % have donated voluntarily only once, % were family donors, % regular volunteer donors, and % have donated voluntarily several times and did not want to donate anymore. from those who have donated, % have donated for one of their relatives, % have donated for thalassemic children, % have donated to benefit free check-up and % have donated because it was valuable for their health. the question as to whether they would voluntarily donate again, % have answered yes, % no and % were still not sure. this means that donation of those who have donated once did not leave a positive impression, did not increase the desire to repeat the donation once again, rather it has restrained or made it unsafe for them to repeat donation. among the causes mentioned by the interviewees were bad conditions in the donation facilities, staff behavior, inadequate treatment, they did not feel good after donation and had hematoma at the venipuncture. summary/conclusions: based on the results obtained from the study, the national blood transfusion center needs the establishment of a genuine promotion department where there is a need for a transfusion doctor who should be an active part of it. the national blood transfusion center should build up and implement a rigorous retention policy for voluntary blood donors, as the study found out that around % of donors who have donated once would like to donate again. their attraction through a donor retention policy will surely lead to self-sufficiency with safe blood. the safe blood is a public good and for this reason it is the duty of all state instances, the media and non-governmental organizations to give their support in the promotion of voluntary blood donation. background: smoking, unhealthy diet, sedentary behavior and inability to maintain adequate exercise have significant consequences for several chronic disorders, including obesity. a balanced and equilibrate nutrition may prevent the negative consequences associated to the status of obesity. in italy, overweight and obesity is increasing with adults of overweight and of obese in with a higher frequency in the south. blood centers can play a public health role in obesity surveillance and interventions. aims: since the quality of life, self-reported by the patient, related to health and adequate quali-quantitative nutrition, are becoming necessary and relevant in the field of nutrition, we conducted a demographic study to evaluate the health status of the blood donors by monitoring the nutritional habits and lifestyle. methods: a descriptive cross-sectional face-to-face questionnaire was developed. it included a item dietary assessment, reporting semi-quantitative food frequency, dietary behavior and questions on self-rated health status. normal weight was established with bmi < kg/m , overweight with a bmi ≥ and < kg/m , and obesity with bmi ≥ kg/m . obesity prevalence was standardized by sex. donors were repeat blood donors, who had made at least donations in the last years, and were eligible to donate. results: of the blood donors enrolled between july and january , were regular repeat donors, did not wish or chose not to respond at survey for several reasons (i.e. lack of time or privacy) and accepted, of which were deferred from blood donation and were excluded from the analysis. among the included participants . % (n = ) were male, age ranged from - years with a mean age of . ae . sd and . % (n = ) were female age ranged from - years with a mean age of . ae . sd. data showed that donors followed mainly a mediterranean diet and had more awareness to lifestyle, women more than men, in comparison with general population. the prevalence of overweight was found . % in men and . % in women. our survey showed that . % of the participants evaluated their health as "good", without gender difference (men, . % vs women, . %). besides, . % reported their health as "very good". summary/conclusions: overweight and obesity are common among regular blood donors and it is more frequent in men than women. our preliminary data showed that women have a better knowledge of the nutritional properties of food and consequently adopt a more balanced and proper diet. furthermore, it is clear that they are aware about the relationship between lifestyle and health putting into practice their information. unfortunately, the survey structure, of observational nature, does not make it possible to establish whether women are more alert to health to participate more in donation programs or if, on the contrary, the status of regular donor could help the improvement of knowledge and healthy lifestyle. background: donor recruitment pose an ongoing challenge to blood banks worldwide. one approach to improve the effectiveness of donor recruitment is to target influencing factors. a yearly league is conducted at the sultan qaboos university (squ) to encourage university students and faculty to donate blood. during this, the colleges are evaluated based on different measures including the number of donors recruited from each college and the efforts made by the students in increasing the awareness of blood donation in the colleges and in the society via different means including the utilization of the social media. the whole competition is organized and ran by an independent group of students. aims: this study aims at studying the impact of the yearly squ college competition on the perception of blood donation among squ students. methods: a comprehensive anonymous voluntary survey was developed and used to assess perception of students aged - attending squ and other universities (non-squ) over a two years' period. analysis was performed using ibm spss statistics . . categorized variables were presented in numbers with percentages and associations between the groups were analyzed using chi-square test. a p-value of < . was considered statistically significant. results: a total of students were surveyed ( squ, non-squ). there was no statistical difference between squ and non-squ students with regard to past history of blood donation and the number of donations made. when comparing between both cohorts, % of the squ and % of non-squ students reported the university as the main source for information (p < . ), while % of squ and % of non-squ students reported that the social media was the main source respectively (p = . ). there was no statistical difference between male and female donors on their perception of level of self-knowledge on blood donation (p = . ). about % of the youth agreed that blood donation is one of the duties toward the community. squ students reported higher rates of respond to specific requests for blood donation ( . % vs . %, p < . ). squ students reported greater influence of peers ( % vs . %, p < . ), personal knowledge ( % vs . %, p = . ) and personal experience ( . % vs %, p = . ) when compared to non-squ students. they also reported more feeling of commitment to the society ( . % vs %, p < . ). squ students reported lower influence of parents ( % vs %, p = . ), lower rates of fear from needles ( % vs %, p < . ) and lower rates of fear from blood ( % vs %, p < . ). there was no difference between male and female genders in any of the discouraging factors. summary/conclusions: these results highlighted the positive impact and important rule of the youth in the promoting blood donations among themselves through this yearly college competition; in recruiting blood donors and in the dissemination of the knowledge of blood donation. distinct promotion strategies should be adopted to increased first time and repeated blood donation among the youth. we advocate for similar initiatives in encouraging blood donation and disseminate knowledge among individuals in the community. dubai blood donation center, dubai health authority, dubai, united arab emirates background: dubai is multicultural city in united arab emirates. only about % of the population consists of uae nationals with the rest comprising expatriates from various countries all over the world. approximately % of the expatriate population (and % of the emirate's total population) are asian, chiefly indian ( %) and pakistani ( %). dubai blood donation centre is the only centre providing blood donation services in dubai. arabic is the national and official language and english is used as a second language. in order to have good quality screening, it is important that blood donors understand the educational material and questionnaire properly. aims: dubai blood donation centre receives donors (nationals, residents and gcc card holders) from various countries. the aim of this study is to analyze the multinational profile of donors and to find out the need to add any third language to meet the customer needs and expectations. methods: a cross-sectional study of blood donors was conducted in dubai blood donation centre in . the donors were asked about their country of origin, languages which they can read & understand and about the preferred mode of communication. results: a total of donors were surveyed and asked about the languages which they can read and understand and responses were obtained. the most common languages which can be read and understood by blood donors in dbdc are english (n = ; %), arabic (n = ; . %), hindi (n = ; . %) and malayalam (n = ; . %). the donors come from different countries, most common ( . %) donors are indian and ( . %) are from uae. it was found that % donors can read and understand only one language. majority ( . %) donors can read and understand either of the official languages arabic or english. however, ( . %) donors can't read and understand these two official languages, the other common languages being hindi and malayalam. the donors were asked about the preferred mode of communication, responses were obtained. the most common mode of communication were sms and telephone ( % together). summary/conclusions: based on the above findings, it can be concluded that the blood donor profile in our centre is multinational which is a unique and almost similar to the population profile of dubai. as . % donors can't read and understand arabic and english, so it has been decided that the educational material and questionnaire need to be prepared in one more language. hindi has been decided as the third language in the centre and donor questionnaire and educational materials in hindi will also be made available to the donors. further,the donors will be communicated through sms for routine messaging and disease notification while telephonic calls will be done only when the blood is urgently required. background: metabolic disorders (metds), including hypertension, dyslipidemia, hyperglycemia, and central obesity, are tightly associated with cardiovascular diseases and type diabetes mellitus. due to the sedentary lifestyle and increased consumption of high-calorie diet in modern society, metds have become serious health problems worldwide. to have a better understanding and possible improvement on blood donors' health condition, we conducted a survey of the prevalence of metds among blood donors in a blood donation station located in the hsinchu science park in taiwan. participants with metds will be provided with health education materials about metabolic risk reduction, in order to prevent the development of future complications. aims: the aims of this study were to determine the prevalence of metabolic disorders among blood donors, and to calculate how much money would be paid to identify a case of hyperglycemia, hyperlipidemia, or undiagnosed diabetes. methods: this study was approved by the institutional review board of taiwan blood services foundation (tbsf). the body weight, body height, waist circumference (wc) and blood pressure (bp) of participants were measured. blood samples were obtained to determine the values of hemoglobin a c (hba c) background: the law on blood donation supports the development of the blood service and guarantees the protection of the donor's rights and the maintenance of health during blood donation in the russian federation. national criteria for donor selection for blood donation are used in the activities of blood service establishments and are aimed at ensuring the blood products safety. the study of the characteristics of blood donors allows to predict the development of blood service and to plan the volume of blood products for transfusion and plasma fractionation. aims: the aim of this work was to study the characteristics of whole blood and apheresis donors in the blood service in the russian federation. methods: indicators of activity in the blood service establishments in the russian federation in sectoral statistical observations over the period - and the calculation of indices characterizing the whole blood and apheresis donors were analyzed. data are presented according to the administrative division of russian federation into federal districts (fd). results: the proportion of whole blood donors was . %, plasmapheresis donors - . %, blood cell apheresis, including plateletapheresis, donors - . %. for the period - , the percentage of repeated and regular whole blood and apheresis donors increased from . % to . %. the percentage of first-time donors ranged from . % to . %. the largest proportion of plasmapheresis donors was observed in the volga fd ( . %). about . % of the total plasma was collected by apheresis from donors. the percentage of plateletapheresis donors increased from . % to . %. the largest percentage of plateletapheresis donors was observed in the central fd ( . %), where a significant part of medical centers of cardiac surgery, hematology and bone marrow transplantation are located. the proportion of platelet concentrate collected by apheresis increased to . % in . actions to recruit young donors for blood donation and its components were regularly carried out in all federal districts. summary/conclusions: in the russian federation, the structure of donation is characterized by an increase in the proportion of plateletapheresis donors, stabilization of the percentage of plasmapheresis donors and an increase in the proportion of repeated and regular whole blood and apheresis donors. there are significant regional variations of donor's characteristics in the federal districts. background: shortage of blood supply despite continuous blood donation campaigns especially during local festive seasons has been a major issue in our country. thus, our faculty initiated blood donation drives in collaboration with national blood centre in order meet the demand for the blood requirements. however, the pre-donation deferral rate was relatively high among our young blood donors leading to loss of valuable blood units. understanding the causes of donor deferral provides direction on strategies for young donor recruitment and retention of future blood donation. aims: the aim of this study is to evaluate the young donor deferral pattern and to identify factors which could help in minimizing the preventable deferrals. methods: this is a retrospective study of voluntary young blood donors age between to years old recruited during mobile blood donation in faculty of medicine, universiti teknologi mara, malaysia. the study was conducted between january to december . the data were retrieved from the official reports of each mobile blood donation. results: a total of young blood donors had attended mobile blood donation during the study period. the overall pre-donation deferral rate is . %. the main causes of deferral are low haemoglobin (hb) level ( . %) followed by low blood pressure ( . %), upper respiratory tract infection ( . %) and sleep less than h ( . %). summary/conclusions: low haemoglobin and low blood pressure are the two common reasons for blood donation deferral among our young blood donors. in our study a significant proportion of deferrals are due to sleep less than h whereby this could be prevented if the donors are aware of the donor selection criteria. strategies to mitigate preventable deferrals and improve blood donor retention particularly young blood donors as source of motivation for future blood donation are urged to avoid additional stress on the blood supply. background: in the modern world, donating blood has become a humane manner for saving of patients life. but there are barriers to blood donation which are designed to ensure both donor and blood recipients' safety. anemia is one of the most common health problems in the world. based on the who estimation, nearly a quarter of the world's population are suffering from anemia, its prevalence varies among the populations and age groups. the prevalence of anemia among men is . % and in non-pregnant women is . %. aims: the aim of this study was to determine the status of hemoglobin in volunteer blood donors referring to fars province blood transfusion service and to determine the demographic status of them during the last two years. our study included blood donors for all blood donors during the last two years. methods: the study is descriptive cross-sectional and our sampling was non-random and simple sampling method. all parameters related to the donors, including age, sex and type of donation were investigated and analyzed in spss software. results: the total number of referrals for blood donation was . repeated blood donors was . % of total population and had the highest number of referrals, followed by first and lapsed donors with . % and % respectively. in terms of gender distribution, . % were female and . % were male. the highest rate of hemoglobin level less than . g/dl was found in first-time donors with . % and the lowest prevalence was observed in lapsed donors, followed by repeated donors with . %. . % of the repeated blood donors have hemoglobin higher than . . there was a significant difference between blood donation type and hemoglobin level. summary/conclusions: according to our findings, low hemoglobin levels are more common among first-time and female donors, and this requires a special training among these groups. because the high share of first time donors in blood supply and the positive impact of female donors on the blood safety, corrective action for that groups is recommended. finnish blood donor biobank j partanen, t wahlfors, m arvas, j clancy, k l€ ahteenm€ aki, e palokangas and n nikiforow background: the increasing need for large, well-characterized cohorts of healthy individuals for modern biomedical research, such as genomics or phenomics studies typically including tens or even hundreds of thousands of subjects, has posed the possibility of using blood services as an option for collecting samples and related data. the possibility to re-contact blood donors for repeated sampling or asking for additional data has further increased interest in collecting large biobanks from blood donors. there is also a need to study more thoroughly the effects of blood donation on donor health. aims: the first-phase goal is to recruit , blood donors with broad biobank consent for the finngen (https://www.finngen.fi/) project, a large publicprivate effort aiming to collect genome and health-related registry data of % ( , ) of the finnish population. ( . %), dental examination ( . %) and medication history ( . %). permanent deferral namely, risk factor involving transfusion transmitted infections and chronic disease were ( . %) and ( . %) respectively. the prime cause of permanent deferral was risk factor involving transfusion transmitted infections while the temporary deferral was bed side hypertension. gender wise, the leading cause of donor deferral in male was bed side hypertension and anaemia was the major cause in female. summary/conclusions: the findings of the survey aid to evaluate the significant causes of blood donor deferral. this study suggests that the restrictive criteria can be used for blood donor selection. this will in turn increase the blood supply of tertiary care hospital. background: donor selection is the first step towards safe blood but retaining blood donors is also very important for the blood supply. donor questionnaire and the medical interview should provide optimal doctor deferral. aims: to evaluate deferral rate in blood donors in order to identify the main reasons and to target eventual corrective activities. methods: we analysed the data concerning blood donors who were registered in the period of three years ( - ). we used data from the information system e-delphyn. background: iron deficiency (id) in blood donors is an underestimated issue in many countries and may cause symptoms to blood donors even without anemia. id prevention is mainly based on the prevention of anemia in whole blood donors, which is done by deferring donors whose haemoglobin level is under defined threshold ( g/l in women, g/l in men in france). efs (french blood establishment) studies has observed that the rate of deferral for anemia is significantly higher in women than in men, either in french west indies ( . % versus . %) or in continental france ( . % and . %). assessing the prevalence of id is of great interest since strategies to counteract it must deal with donor health and self-supply. however, data on id are missing in france. aims: to estimate the prevalence of id in french whole blood donors and to identify risk factors associated with id. methods: this non-interventional, cross-sectional, multicenter study is performed in blood donors of efs and ctsa (blood center of the french military health service). all whole blood donors who met selection criteria are potentially included. donors coming for bloodletting and donors who refuse to participate to the study are excluded. no additional sample is taken for the study, ferritin is tested after blood qualification on surplus amount. samples are selected at random within all the geographical areas and all mobile blood drives and blood centers between march and march , . results: this study ferridon has been approved by ethical research committee. nine thousand ( ) whole blood donors will be included in efs centers in continental france. to have information on donors of afro-caribbean origin and comoros origin, donations should be included in the french west indies and in reunion island. additionally, whole blood donors will be included in ctsa centers. in this study, id is defined by ferritin lower than ng/ml and iron overload is defined by ferritin higher than ng/ml. all donors with iron deficiency or overload will received a letter advising to consult their general practitioner. weights will be calibrated on age, sex and geographical area so the sample will be representative of the french whole blood donors. estimation of id prevalence will take into account the weights and logistic regression model will be used to analyze risk factors associated with id. data will be analyzed during april and may to get result at the end of may. summary/conclusions: ferridon will be the first study on id in the french blood donors. considering the french health care system and diet, it will be interesting to compare those results to results from other countries. mostly this study will allow to consider various strategies dealing both with donor safety and self-supply. background: in portugal, with an aging population of around million people, only . % are blood donors. the country has a national center of blood supply and some central hospitals with a blood donation center. despite the growing practice of the excellent concepts of patient blood management, it is imperious to attract new donors. this need has been our inspiration to use new approaches towards people, in a constant work of promotion. aims: reach the majority of our local population using radio and telecommunication as well as social networks in an attempt to raise the number of new blood donors in a central hospital of the north of portugal. methods: active communication with the population of our reference area, via the social networks facebook tm and instagram tm , through educational digital posters and messenger service to answer any kind of questions. establish contact with radio and television stations as well as with the mayor of the city, journalists, schools, town hall deputies and celebrities, through email and telephone calls. design posters, flyers and public advertising to distribute in the city. results: through the social networks it has been possible to reach a population of dozens of thousands in our city, in a daily basis. the national and world donor days were celebrated with success, in our health facility, with city mayor and journalists, and also in three television stations with national broadcast, reaching millions of people. celebrities (sport, television, music, stand-up comedy, journalists and a magician) have accepted our challenge through videos or donating blood, appealing to blood donation and sponsoring our cause. these projects and continuous availability to innovate have given our hospital a self-sufficiency of % in , instead of % in , which implied receiving less blood unities from the national center of blood supply. our most recent project involves high schools, in an attempt to educate our next generation of donors, with meetings in the town hall with deputies and district school delegates. summary/conclusions: the aging population and the low percentage of blood donors are an important issue concerning public health. nevertheless, the good will and continuous advertising and educative work towards the population, appealing to the ethical and civil responsibility since young ages have shown to improve our capacity of response as a central hospital, increasing the auto-sufficiency of blood unities and the interest of younger donors. it is of the utmost importance to understand that this is a continuous and a hard work of the professional team of our hospital, involving countless calls, emails and hours to obtain some positive response, in an endless job. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the mean interval between donations is shorter for former regular donors ( . months, p < . ) whereas donors with an interval of to months are more likely to be regular (aor ; % ci . - ). summary/conclusions: at the provincial blood transfusion centre of bukavu, the percentage of regular donors is low and there is a substantial loss of former regular donors. some factors identified to be linked to fidelity are unique to our study: female gender and a longer interdonation interval. other factors that are similar to those found elsewhere have a particular significance in our donor population which consists mainly of young people and people without income. efforts must be undertaken to ensure a supply from voluntary donations; recruitment strategies and target groups must be refined. future qualitative studies are needed to explain the various associated factors and better understand the motivations of regular and non-regular donors to improve donor retention. results: in kazakhstan, the proportion of donors is higher, especially primary. the number of blood and especially plasma donations is higher, which can be explained by the presence of several albumin and immunoglobulin production sites. increased evidence of blood transfusion rules, the development of a patient's blood management in combination with an increase in the quality of blood components cause a reduction in clinical need for red blood cells and plasma for transfusion. at the same time, the need for platelets is growing. it is difficult to assess the correctness of comparing the amount of banked whole blood. it is equally difficult to compare the number of received and distributed donor red blood cells and plasma: in russia they are measured in liters, and in kazakhstan in doses. with a certain degree of conditionality platelet extraction can be compared. in russia, they are counted in equivalent doses isolated from a dose of whole blood (at least cells per dose), and in kazakhstanin therapeutic doses (at least cells per dose). in , the estimated consumption of platelets in kazakhstan exceeded the russian indicator by . %. % of platelets in kazakhstan and . % in russia are harvested by the apheresis method. inactivation of pathogens is performed in % of platelets in kazakhstan and in . % in russia. pathogen inactivation with amotosalen allows us to abandon the examination of donors for cytomegalovirus and irradiation of platelet concentrate. the main modern trend in the use of cryoprecipitate is using it as a source of fibrinogen, a blood coagulation factor that is first depleted in coagulopathy associated with injury and massive bleeding. its production is growing in both countries, endowment in kazakhstan in exceeded the russian indicator by . %. a significant plasma percentage in both countries does not pass quarantine due to repeated non-appearance of the donor and is subject to destruction. inactivation of pathogens is performed in % of plasma in kazakhstan and in . % in russia. despite the instruction and selection of donors, laboratory screening of infection markers remains effective: russia more often identifies hiv and viral hepatitis c from potential donors, and viral hepatitis b and syphilis are detected in kazakhstan. . % of donors in kazakhstan are exempted due to the results of multiplex screening of nucleic acids of three hemotransmissive viruses. summary/conclusions: the blood services of russia and kazakhstan perform tasks to provide medical organizations with effective blood components. in conditions of decreasing demand for red blood cells and plasma, it is advisable to focus on the efficiency of resource use and improving the quality of blood components produced. blood collection including apheresis p- finnish red cross blood service, helsinki, finland background: skin disinfectant must effectively reduce microbes from the arm of the donor. as a result of poor disinfecting microbes may be transferred from skin via venepuncture to the collected blood and contaminate the blood components. aims: to ensure the efficiency of the skin disinfectant used for donor arm disinfecting by validation. the validation has two criteria which the post-disinfection samples must achieve: . no bacteria growth near the puncture spot (result cfu) in ≥ % of the samples. . total amount of bacteria on average is at most cfu/ cm . at most % of samples are allowed to have - cfu/ cm . methods: microbiological samples were taken with contact plates from voluntary persons' elbow folds before and after skin disinfection. the disinfecting was performed according to normal procedure by five nurses altogether with ethanol based disinfectant used in blood donation. on the sample plates an x was marked and this was directed to the puncture spot pointed by nurse. post-disinfection sample was taken at the moment the skin would be punctured with needle. results: the amount of bacteria varied from to above cfu/ cm in the pre-disinfection samples. disinfection reduced bacteria very well; the critical puncture spot was totally clean ( cfu/ cm ) in . % of the samples and . % of the samples had or only cfu/ cm . the average number of bacteria after disinfection was , cfu/ cm and the maximum number was cfu/ cm . most of the remaining bacteria were single colonies at the edges of the plates. summary/conclusions: both main criteria are fulfilled. the sub criteria of the second main criteria is also full filled if the not so critical colonies at the edges of the plates are not taken into account. the skin disinfectant in question is shown to be effective and can still be used in blood donation paying attention to thorough procedure performance according to the instructions and sufficient drying time of the disinfectant. background: research questions involving blood donation and recipient data often require advanced statistical methodologies. while such methodologies may appear in other medical research areas, specific tailor-made statistical tools and approaches are required for the analysis of blood-related data. these toolkits, which often require collaboration, are not always readily available to blood services, especially so in resource-limited settings. an international network of statisticians, epidemiologists and clinical researchers has been established for this purpose, which started with an invited session at the meetings of the international biometric society. aims: to exchange ideas, experience and knowledge to further improve the quality of blood sector research. methods: currently our network covers four major blood services and members from five different countries. the network has monthly conference calls about past and current research topics. we wish to extend this network further, and establish a subcommittee on statistical and epidemiological methodology with regular face-toface meetings at an international organization such as isbt. results: the monthly meetings have already demonstrated that the members share common problems and interests. for example, we are discussing techniques to analyze data with repeated measurements, e.g. eligibility haemoglobin tests, ways to assess the healthy donor effect, e.g. determining appropriate controls groups, and predictive models of blood supply and demand, e.g. stochastic processes and queuing models. the network also aims to organize training sessions in methodology either on site and/or by developing web lectures. summary/conclusions: an international network on statistical methodology for the analysis of blood donation and recipient data will improve the quality of research in the field of transfusion medicine research. expanding the network to include countries and blood services in research limited settings needs to be actively pursued. background: blood donor hemoglobin concentration (hb) is commonly measured from a skin-prick sample at the donation site, and low hb is the most common reason for temporary donor deferral. while a proportion of the deferrals do reflect true low hb, the skin-prick sample is prone to preanalytical error and variation resulting in false deferrals. aims: we assessed the applicability of a venous blood sample for second-line hb screening in blood donors failing the initial skin-prick test. methods: initial hb was measured from a skin-prick sample with the hemocue hb + (hemocue ab) point-of-care (poc) device. donors with hb < g/l for females or < g/l for males or with a decrease > g/l from latest donation were included in the study. in the study group, a venous blood sample was collected for hb measurement with the poc device at the donation site. donation eligibility was based on this hb result. venous hb was also determined with a hematology analyzer (sysmex xn, sysmex co.). the blood service's current workflow served as the control group: two more skin-prick samples were collected and the donor's final hb and donation eligibility assessed with an algorithm based on all three skin-prick hb results. results: in the study (n = ) and control (n = ) groups, the proportion of male donors ( % and %) and the mean initial skin-prick hb ( g/l and g/l) were similar. significantly less donors were deferred from donation in the study group ( %) than in the control group ( %; chi-square test p = . ). the mean difference in venous hb with the poc device versus the hematology analyzer was À g/l (range À to + g/l). two donors were incorrectly accepted based on venous sample poc result; however, in both, hb measured with the hematology analyzer was only g/l below the limit of donation eligibility ( g/l for a female and g/l for a male). interestingly, a further donors ( % of all deferred in the study group) would have been eligible for donation based on the hematology analyzer result. summary/conclusions: utilizing a venous blood sample for second-line screening of donors failing the initial skin-prick hb test significantly decreased low hb deferrals without compromising donor health. blood donors' and blood service nurses' reactions to the new workflow have been favorable. we conclude that valuable donations can be recovered and donor satisfaction increased by implementing a second-line hb screening model utilizing venous sample analysis at the donation site. background: there is a paucity of literature on haemoglobin (hb) reference values for adults above years of age. this age group has been reported to use up to % the blood supply. some studies report a decline of mean hb with age, but others have found no change with age. conflicting findings of hb levels in the healthy elderly population may be associated with challenges in accessing data from healthy older adults, small sample sizes, selection bias and recent health population data. to donate blood, each individual is assessed as 'healthy' and must meet the minimum hb criteria. however, the hb criteria across countries vary and many blood collection services have an upper age limit for donors. as many populations around world are aging, restricting the upper age limit for blood donation may potentially affect the size of the donor pool and consequently the nation's blood supply. aims: to explore the hb levels of healthy older adults, through a multi-centre retrospective observational study of blood donors aged years or older. methods: over a one-year period, hb values were collected from blood donors aged ≥ years from blood centres of four countries. the estimated proportion of blood donors aged ≥ years old for each country was . % in south korea (sk); . % in hong kong (hk), < . % indonesia (indo) and % in japan (jap). the minimum hb criteria varied between each country and ranged from . - . g/dl for women and . - . g/dl for men. hb levels were determined using point of care testing (hemocue, compolab, hemcontrol) or the xe- d sysmex dependant on the country of origin. statistical analysis of the mean, standard deviation and cumulative distribution of hb were determined by gender and age. background: medication usage is assessed to determine donor eligibility from the perspective of both recipient and donor safety. different time frames since last taken apply to different medications. assessment of medication use varies by jurisdiction, but most european centres use multiple questions. these often include a general question about recent medication use whereas the usa does not. at canadian blood services there are medication questions on the donor history questionnaire (dhq), including any medication use in the last days, vaccination and specific medications over different time frames (high teratogenicity medications). the name of each medication taken and reason for use are documented by staff at each donation attempt. assessment of the frequency with which this process occurs is the first step in improving efficiency of this aspect of donor screening. aims: to determine the percentages donors answering yes to medication questions by demographic variables. methods: all whole blood donors who completed the dhq (full length or abbreviated) in were included in the analysis. donors' answers to each of the medication questions were extracted from the national epidemiology donor database, as well as sex and age. the number and percentage of donation attempts in which a donor answered yes to each medication question were calculated. donors who answered yes to any medication question were sorted by sex and by age group, the totals and percentages calculated. results: there were , donation attempts with a completed dhq. overall, % of donors answered yes to medications in the last days, % to vaccination, and less than . % to others ( % any). slightly more were female ( vs %) of those who answered yes to any medication question, as well as by individual question. the percentage of donors answering yes to any medication question increased progressively in each age group from % of - year olds to % aged + (p < . for trend). summary/conclusions: more than one third of all donation attempts answer yes to a medication question and require further questioning and documentation. this is more common in older donors and follows a similar trend to general population medication use. comparison of ways of assessing medication use in different countries may help identify effective but more efficient approaches. in addition, the contribution to donor and recipient safety of assessing all medications should be assessed. blood center experience with trima accel and tomes software j schreier , a davison , j gambarte , y l opez , c calonge and e herranz terumo bct, lakewood, united states centro de transfusi on de la comunidad de madrid, madrid, spain background: in the madrid community, more than apheresis platelet collections were completed in , of which almost were completed in the blood transfusion center and the remainder in several hospitals in the region. trima accel was implemented to meet the productivity needs of the blood transfusion center while improving the donation experience. tomes (terumo operational medical equipment software), which enables bidirectional communication with trima accel devices, was used to connect and centrally manage all trima accel devices with automated data capture and reporting. aims: the aim of this study was to evaluate operational improvements using trima accel with tomes compared to trima accel version . methods: this was a retrospective study analyzing apheresis procedures on trima accel version during the control period from january to september compared to apheresis procedures on trima accel during the test period from september to december . this was not a paired study. operator interventions, and completed procedure rate comparisons, were analyzed using a -proportions test, whereas donor demographic data were analyzed using a -sample t-test. results: trima accel was used to collect single and double platelet products stored in platelet additive solution. operators selected either a single (target platelet yield = . or . ) or double (target platelet yield = . ) platelet donation based on desired procedure time not the maximum number of products that could have been collected per donor. no statistically significant differences were observed for donors in the test arm compared to donors in the control arm for total blood volume (control = ml, test = ml, p = . ), hematocrit (control = . %, test = . %, p = . ), or platelet pre-count (control = / ll, test = /ll, p = . ). females represented % of donors in the control arm compared to % of donors in the test arm. platelet split rate (platelet products per procedure) increased from . with trima accel version to . with trima accel ; procedure time decreased from . min to . min for single collections and from . min to . min for double collections with trima accel (these differences were not statistically significant). the percentage of procedures that completed with no operator interventions due to access alerts increased from . % to . % (p < . ) and the rate of completed apheresis procedures increased from . % to . % (p = . ) with trima accel . manual transcription of data during the procedure was discontinued with the implementation of trima accel with tomes. tomes captured procedural data and operator steps with barcode scanning and tracking of configured events. this information was transferred to tomes post procedure and printed as a final report. summary/conclusions: trima accel significantly decreased operator interventions, and automated data capture with tomes eliminated manual transcription of data. both outcomes freed operators to complete other tasks and focus on donor well-being. background: the european committee (partial agreement) on blood transfusion (cd-p-ts) of the council of europe (coe) has appointed a working group (wg) to focus on issues with plasma supply management (psm). the task of the wg is, among others, to collect and analyze data in order to fill knowledge gaps concerning donor safety in plasmapheresis. in doing so, the working group will gather evidence base data to support the upcoming revision of the th edition of coe's "guide to the preparation, use and quality assurance of blood components", the blood guide. an international survey was conducted sept-dec , distributed to blood establishments (bes) by the cd-p-ts representatives to coe's member and observer states. the questionnaire included sections covering collection practices (volume and frequency), management of red cell loss, donor panel demographics and data on donor adverse events. aims: the aim of this study was to investigate whether collection practices following the recommendations published in the blood guide for maximal collection volumes and number of donations per year were indeed associated with higher levels of donor safety and improved donor base sustainability. methods: from the total of respondents, bes collected plasma for fractionation (pff) by apheresis and the study had a dataset covering , , plasma donations in the latest fiscal year (lfy). the parameter used as marker of donor safety was the rate of immediate vasovagal reactions with loss of consciousness (vvr with loc) per , plasma collections. the parameter used as marker of donor base sustainability was the retention rate of donors, ie % donors active in the previous year returning to make a donation in the lfy. results: in the blood guide, the collection volume per apheresis is limited to % of the estimated total blood volume but maximally ml, including anticoagulant. respondents had differing practices and scale of collection program be were aligned or lower, and be had higher collection volumes. altogether reported the immediate vvr with loc rate, which mainly was lower than / collections. there was a small trend towards reduced rate with larger collection volumes than allowed by the current blood guide. saline compensation during or after collection did not affect the rate of vvr with loc. no correlation was observed between the annual donor retention rate and the rate of vvr with loc or saline compensation practices, as reported by respondents. the retention rate banded in the range of %> % (mean = %, min = %, interquartile range = %, max = %). the association between maximum allowed yearly plasma collection ( l) appears to be reasonably constant and showed no clear association with the donor retention rate. summary/conclusions: restricting the maximum collection limit according to the current blood guide was not associated with either lower vvr with loc or with higher donor retention rate. this study supports reassessment of current blood guide s limits for collection volume of maximum of ml per donation and l per year per donor. methods: serum ferritin concentrations were established from sera stored at À °c from repetitive platelet donors between and , using architect â ferritin assay chemiluminescent microparticle immunoassay (cmia). the hematimetric parameters were evaluated in a total blood sample using the celldyn â . sixteen samples were obtained from women (age: . ae . years, range: - ) and samples from men (age: . ae . years, range - ), corresponding to . % and . % of the total female and male repetitive donors of platelets by apheresis using trima accel â terumo-bct and amicus tm fresenius-kabi. the difference in the concentration of serum ferritin between the last and first donation was established, as well as the change in the predonation platelet count between the last and first event. results: in the study population, . % of women and % of men performed repetitive donations of platelets by apheresis with an interval of less than three months. the change in ferritin concentration was evaluated according to the interval between donations. in women ferritin delta was À . ae . ng/ml when the donations had an interval less than three months, vs . ae . ng/ml when the time between donations was higher (p = . ). in men the change in the ferritin levels was À . ae . ng/ml with donation times less than three months vs © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - À . ae . ng/ml with prolonged donation times (p = . ). in women, the change in platelet count was À ae . /ul, when the donations had an interval less than three months vs À ae . /ul when the time between donations was greater (p = . ). in men, the delta of the platelet count was À ae . /ul in donation times less than three months vs À ae . with higher donation times (p = . ). no correlation was found between the concentrations of serum ferritin and the platelet count (r = . , q = . for males, and r = . , q = . for females). summary/conclusions: the data obtained suggest that repetitive donation of platelets by apheresis with intervals between donations of less than three months, significantly reduce serum ferritin concentrations in women and men, although normal levels were maintained in both groups. there was no correlation with platelet count. therefore, it is proposed to develop prospective studies to establish the minimum time interval safety for platelet apheresis donor procedures. background: the demand for platelets concentrates is increasing continuously and becomes a challenge for the blood establishments. apheresis platelet collections may be a solution for this challenge. improving apheresis collection efficiency while maintaining blood donor safety is an important goal for the service du sang of the belgian red cross. aims: our establishment evaluated the improvements of the trima accel automated blood collection system version (ta ) by comparing its routine performance with that of the previous software version . (ta ). methods: prospective, multi-site, controlled, non-randomized trial. apheresis collections were performed in three sfs sites: liege, mons and namur using the two trima software versions ta and ta sequentially. data were collected from december to april on ta and from june to july on ta . simple and double doses of platelets (respectively . , . and . , . ) were collected in platelet additive solution (ssp+, macopharma) with concurrent plasma from the same cohort of donors in accordance to donor's eligibility and preferences. in order to maintain the same final platelets content in platelets concentrates, the trima accel's tool yield scaling factor (ysf) was subsequently adjusted from . (ta ) to (ta ). platelet yield, duration of procedure, number of alarms requiring operators' interventions were recorded and evaluated. donor's hypocalcemia was avoided by giving preventively oral or intravenous calcium which was documented by the operators. results: five hundred ninety ( ) collections with ta and with ta were recorded, with % and % complete procedures respectively. mean duration of procedures was min on ta against min on ta , p < . . the mean alerts number per procedure on ta was . against . on ta , p < . whereas the maximum alerts number per procedure was and respectively. on ta , % procedures did not require operator's intervention against % on ta ,. with ta the inlet flowrate was automatically adjusted in . % procedures. the inlet flowrate was increased in response to access pressure in . % of procedures, for % of the procedures the inlet flowrate was decreased and for . % of the procedures the inlet flowrate was increase and decreased on the same procedure by the ta autoflow system. summary/conclusions: ta with its autoflow function improves apheresis donors experience while decreasing operator' interventions through a significant reduction of access draw alerts. as expected from the trima accel platform, post-donation safety remains high. a weak increase in procedure duration was observed for the same platelet yield which may be resolved with further adjustments. background: trima accel system is an apheresis platform relying on continuous flow centrifugation to collect from a donor platelets, plasma or rbcs based on donor qualification. the latest software version -trima accel (ta ) introduced the autoflow feature which allows for automated flow rate adjustments. moreover, ta leverages the mobilization capacity of the spleen increasing potential platelet productivity while maintaining high post-donation safety standards characteristic of trima accel. aims: the objective of this evaluation was to assess the impact of ta software by retrospective comparison of procedure data and potential for increased productivity with those of trima accel version (ta ) in the same cohort of platelet donors. methods: eight hundred twenty one procedures, started on ta from th january to th october were compared to procedures, started on ta from th october to st december . procedural data from the trima devices were captured using the cadence system (terumo bct, lakewood co). parameters investigated were the number of machine access pressure alerts per procedure, the potential for higher platelet yield collections and the actual collected yields within the same cohort of platelet donors. results: both donor populations (ta vs. ta respectively) were comparable and were characterized by: tbv - vs. ml; platelet count pre-procedure - ³/ll vs. ³/ll; hematocrit pre-procedure - % vs. %. gender distribution was % female with ta vs. % with ta . venous access pressure alerts were significantly improved by ta with an average of . alerts per procedure as compared to . with ta , i.e. % decrease. this decrease went down to % if only male procedures were analyzed. the maximum number of pressure alerts went down by % from alerts in one particular run in the ta cohort to alerts in one ta procedure. procedure time for single platelet products was reduced from to min and for double platelet products from to min (ta and ta respectively). donor qualification possible was % of procedures yielding single products and % of procedures yielding double products with ta . the percentage of procedures qualifying for doubles increased to % with ta . in terms of split rates, i.e. how many platelet doses could be produced per apheresis collection, potential split rates increased from . to . from ta to ta , respectively. in fact, the observed split rate rose modestly from . to . , as shorter procedures were generally selected according to donors' preferences. summary/conclusions: in comparable donor populations, implementation of ta decreased the number of access pressure alerts significantly compared to previous trima versions. the average procedure duration was also found to be slightly reduced. implementation of ta has the potential to increase productivity significantly. the observed modest actual rise in split rate suggested that factors related to donor and inventory management will determine at which extent the potential of the new software will be used. donor compared experience on trima accel to trima accel version august to october or trima accel during the test period from november to january . this was not a paired study. donors completed the survey while recovering from the apheresis procedure in the cantina. results from the paper survey were transcribed into excel for analysis. results: donors completed the survey during the control period whereas donors completed the survey during the test period. the mean number of previous donations for the control period was . (min max ) and for the test period was . (min max ). there were no first time donors during the control period and first time donors during the test period. % of donors rated their overall donation experience as good on trima accel compared to % on trima accel version . zero ( ) donor rated their experience on either trima accel device as poor. % of donors who responded to the question said they would donate on trima accel again. summary/conclusions: no significant difference was observed in donor experience between trima accel version and trima accel as both versions receive high marks. background: the trend on growth of query for donor platelet concentrates is observed in russia for past few years. as reported by edqm in , a higher number of the platelets was consumed compare to by . %. patients' with hematological malignancies treatment requires platelet concentrates transfusions during chemotherapy, immunotherapy and hematopoietic stem cells transplantation. according to the data collected in national research center for hematology (nrch) in , ( . %) of the , patients, treated within facility, received platelet transfusions as transfusion therapy. the total number transfused units is , , which is higher (by . %) comparing to . platelet concentrates production can be performed either by apheresis process or by pooling individual units recovered from the whole blood. taking into account that the nrch produces blood units for its own needs, the pooling is not suitable method for production because its implementation doesn't cover require for platelets and overproduces rbcs. that is why platelet concentrates in nrch are obtained by apheresis only. in summary, the growth on requirement for platelet concentrates and their safeness explains the need for a comparative study for effectiveness of platelet production using various apheresis systems. aims: the aim of the study is to compare effectiveness of platelet concentrate production using mcs + (haemonetics), upp and trima accel (terumo bct) version . protocols. methods: the data for protocols of platelet donations performed in were analyzed: on trima accel and on msc + . all donors were voluntary and non-paid donors with previous experience of blood donations. the choice of the platelet collection device was random; analysis of the main characteristics of donors did not reveal any significant differences between the groups. the median age of the donor was years old, height - cm, weight - kg, platelet count before donation - /l, hematocrit - %. detailed data are presented in table . student's t-test for unrelated sets was used for statistical analysis of the data. a value p of less than . was considered as significant. results: the data obtained showed significant difference (p < . ) between average number of platelets collected on trima accel ( . ae . /l) and on mcs + ( . ae . /l). while cost of consumables are comparable, trima accel demonstrated . % higher efficiency. procedure duration also was comparable and averaged within min for both devices. detailed data are presented in table . it is crucial to mention that proportion of trima accel's donations was significantly increased in nrch during and reached , % in total ( - . %). a flexible usage of trima accel's consumables for different procedures (regular platelet collection and collection in pas) allowed to change the pas/regular platelets collection ratio from . % up to . %. summary/conclusions: obtained results proved the effectiveness of the trima accel's use for platelets concentrates production. it allowed to increase the average count of platelets obtained for one procedure by . % compared to mcs + while the cost of consumables and procedure duration are comparable. the donor's comfort during procedure did not affect either. in long terms increasing of number of platelets collected is reducing the cost of platelet concentrates production. abstract withdrawn. background: apheresis collected platelet concentrate is preferable in terms of reducing the risks of adverse reactions in platelet transfusion when compared to random donor platelet concentrates. aims: the aim of our study is to present our experience in collection donation of single donor platelets with apheresis. methods: this is a retrospective study performed in the institute for transfusion medicine from till . all donors were fully informed on the donation procedure and signed an informed consent for donation. the optimal platelet count that we want to achieve was ≥ . equal to random donor platelet doses. minimum preapheresis platelet count in donors requested to start the apheresis collection was . /ll. platelet collection was performed using flow cell separators haemonetics mcs+ and trima accel. acid citrate dextrose formula a was used for anticoagulation. median precollection platelet count of donors was . /ll, with range from . /ll to . /ll. male were % of the donors and females were %. the single procedure usually took - min. the median platelet count collected was . , range - . . the median processed blood volume was ml and median used acd-a was ml. mean total volume of collected product was ml. the adverse effects included vein perforation and the numbness of the extremities as reaction of acd-a (hypocalcemia), which occur rarely and was very mild. summary/conclusions: the collected platelet count was more than the wanted optimum platelet count. the number of apheresis donors is increasing and we are working on expanding our voluntary platelet donors registry and increasing the number of typed donors in the registry. background: to determine value of hemoglobin in blood donors, there are some tools or methods used, such as: cyanmethemoglobin method that can detect of hemoglobin quantitative and methods cupric sulfate solutions (cuso ) can detect of hemoglobin qualitative. according to who (world health organization) to determine the level of hemoglobin in blood donors enough used cuso solutions with specific weight (y) . can to detect value of hemoglobin above or same with . gr/dl. but, cuso solution specific weight . can not to detect and elimination value of hemoglobin above gr/dl or polycythemia sick. because it, central blood transfusion unit (utdp) as the central of blood service in indonesia to manufacture cupric sulfate solution (cuso ) with a specific weight (y) to detect value of hemoglobin below gr/ dl and determine value of hemoglobin above gr/dl. because it, do the testing the accuracy of the solution cupric sulfate in detecting and eliminating donor with value of hemoglobin above gr/dl with the test of samples. aims: to determine accuracy and effectiveness by blood donors unit in indonesia red cross to use cuso solution with specific weight . in to detect and elimination value of hemoglobin donors above gr/dl. methods: used the method cyanmethemoglobin and cuso (y) . determination value of hemoglobin donor. test results were analyzed with spss software version using nonparametric analysis wilcoxon test. results: this research testing the accuracy and effectiveness of using a cuso solution with specific weight (y): . in detecting and eliminating hemoglobin value donors above gr/dl. from data processing using spss with the wilcoxon test p value . . summary/conclusions: it was found that the cuso solution (y): can detect hemoglobins value above gr/dl and more effective in checking the hemoglobin in blood donors. it can be seen from the data processing with spss version with the wilcoxon test p value < . . it is important to monitor the precise course by which repeated blood donation affects hb and the probability of low hb deferral. zinc protoporphyrin (zpp) is a functional indicator of body iron levels and is hypothesized to predict hb levels among blood donors. advanced statistical methods are necessary to properly analyze the longitudinal associations between zpp and hb in data with repeated donations per donor. aims: to determine whether predictions of future hb levels using current hb levels can be improved by taking zpp levels into account, and to illustrate the use of statistical models for repeated measurements of blood donors. methods: we used data from the zpp and iron in the netherlands cohort (zinc) study. we identified previous zpp levels (log-transformed) as the main predictor and adjusted for previous hb level, age, day and time of donation, donation history, bmi, blood volume and blood pressure. we used linear mixed models, which take into account missing data in the outcome and associations between repeated measurements, to investigate the longitudinal association between previous zpp and current hb levels. the longitudinal analysis with linear mixed models was contrasted with a simpler analysis based on the area under the receiver-operating-characteristic (roc) curve for the probability of low hb deferral. results: in total, whole blood donors ( , whole-blood donations) were included in the zinc study, % being female donors. previous zpp showed a statistically significant association (p < . ) with hb levels in females, but the size of the association was quite small (regression coefficient, b = À . , % confidence interval À . to À . ). the same was true for males, but the size of the association was even smaller. blood volume and age for women were significant secondary predictor variables; blood volume, age and donation interval for men. by comparison, the roc analyses showed relatively larger, but less statistically significant predictive effects of zpp on hb. summary/conclusions: zpp is a statistically significant predictor of hb levels, but the size of the effect after adjustment for previous hb and other variables is small. the results cast doubt on whether zpp is an effective predictive marker for hb level and low hb deferral, and suggest that zpp should not be included in prediction models for hb levels. by properly adjusting for associations between repeated measurements and by using all available data, longitudinal models provide less biased and more precise estimates than simpler cross-sectional analyses. background: finnish red cross blood service (frcbs) is a national blood service and is responsible for all blood collection and component production in finland. the highest age for blood donors was years until the end of year and since beginning of donors between and years have been able to donate blood. blood donation after the age is possible if the donor has donated within the last months. the upper age limit was raised up based on adverse event data from frcbs donors up to years and on published data from other blood establishments. aims: the aim of this study is to find out if the new policy from with upper age limit of years is safe. therefore donor adverse event data was analyzed in order to evaluate if the blood donors older than years have more adverse events compared to other donors. the most common donor adverse event for donors over years, haematoma, was registered times ( . %). in the other age groups haematoma was registered times ( . %) and the difference between the oldest age group compared to all other donors was statistically not significant (chi , p = . ). vvrs with loc were registered times ( . %), vvrs without loc times ( . ), and the total number of all daes was ( . %) in the age group years or older. the respective numbers in the other age group were: , . %; , . %; ( . %). the number of vvrs with and without loc, and total number of all daes in the age group years and older was smaller than in the other groups and the difference between these groups was statistical significant (chi , p < . ). summary/conclusions: donors over the age of years have less donor adverse events than other age groups. decision to raise the age limit from to seems proven to be right as the older age group has even less donor adverse events than other donors. background: deep vein thrombosis (dvt) of the donor's phlebotomy arm is a rare, but serious complication of blood donation that needs to be recognised and managed appropriately in a timely manner. post donation dvt will be classed as a 'serious adverse events of donation' (saeds)these are events that either result in donor death, hospitalisation, intervention or significant symptoms persisting for more than one-year post donation. aims: to review cases of dvt post donation reported in uk in - years and identify any common themes for improving practice methods: all data relating to saeds from the four uk blood services reported to shot in the last years ( - inclusive) were reviewed to look for reports of dvt post donation results: a total of saeds were reported in uk from approximately . million donations (whole blood and apheresis) collected during this period. three cases of upper limb dvt were reported during this time accounting for % of the saeds reported and rate of dvt of in . million donations collected. -case : a regular male whole blood donor in his early s reported worsening arm pain days following blood donation, had a painful venepuncture and a small bruise at site of donation. he was diagnosed to have an upper limb dvt extending to the subclavian and brachiocephalic vein and started on oral anticoagulants. no other contributory factor was obvious -case : a female donor in her mid- s gave her sixth whole blood donation without event. days after donation, she developed worsening arm pain in the donation arm and was diagnosed with an upper limb dvt and commenced oral anticoagulation. there was no other identifiable risk factor for the thrombosis -case : a female donor in her s developed pain, swelling, redness and itchiness in her donation arm and chest wall two days after donation. she also described prominent veins on the affected side compared to her other arm. she contacted the transfusion service one week after donation; by this time she was also breathless on minimal exertion. she was admitted to hospital and commenced on anticoagulant therapy. a diagnosis of dvt and associated pulmonary embolus was confirmed. the donor's only risk factor for thrombosis was use of the oral contraceptive pill. summary/conclusions: rare complications of blood donation, like dvt, can occur. superficial venous thrombosis may occasionally progress into the deeper veins of the donor's arm but dvt can also occur without signs and symptoms of superficial thrombosis. none of our patients had any overt evidence of superficial thrombosis. one patient in our series reported using oral contraceptive pill. no other risk factors for thrombosis was forthcoming. transfusion services should encourage donors to make early contact with the blood service if they experience arm complications so that they can be investigated and managed in a timely manner. staff dealing with such donors must recognise the possibility of this rare complication, explore other additional contributory factors and initiate prompt and appropriate management. background: voluntary blood donation is widely considered to be safe with very minimum chance of adverse reaction, which may occur during or after the end of phlebotomy procedure. aims: to find the adverse blood donor reaction among voluntary blood donors in tertiary care hospital in kathmandu methods: this is a prospective study done among voluntary blood donors at grande international hospital, kathmandu, nepal from february to march . the outlines of reported and communicated adverse donor reaction were also collected after the blood donation from voluntary blood donors in different locations including outdoor and in-house blood donation drive results: in the present study , whole blood donors were included, during the period of years, ( . %) adverse donor reactions were reported. majority ( . %) of adverse donor reactions were mild in nature such as, sweating; ( . %), light headedness; ( . %), nausea and vomiting; ( . ), allergy and bruises; ( . %), sore arm; ( . %) and hematoma; ( . %) while ( . %) were severe adverse reactions similarly, anaphylaxis; ( . %), loss of consciousness; ( . %) and convulsive syncope; ( . %). markers of the adverse donor reaction were age, sex, pulse, weight, blood pressure and donation status. age and first time status were related with significantly higher risk of adverse reaction with - years old at higher risk compared to - years old. first time donors were at higher risk compared to repeated volunteer donors. summary/conclusions: the results of the study are helpful to identify and understand the complication of adverse donor reactions though the incidence of reactions in the blood donors is lower than in other studies. donor age and donation status were strong possibilities of complications. background: blood donors with pollen-induced allergy and asthma must often refrain from donation in pollen season despite medication, because of symptom severity or similarity to airways infection. extracts of the medicinal mushroom agaricus blazei murill (abm) given orally have been found to reduce ige anti-ovalbumin levels and ameliorate the skewed th /th cytokine balance in mice sensitized to ovalbumin (takimoto, immunopharm immunotox, ; ellertsen & hetland, clin mol allergy, ). aims: the objective was now to examine whether supplementation with the abmbased extract that we used in the mouse model for allergy, could alleviate allergy and asthma in blood donors by reducing specific ige levels and basophil sensitization. methods: sixty donors at oslo blood bank with self-reported birch pollen allergy and/or asthma were recruited and randomized in a double-blinded, placebo-controlled study with oral supplementation for weeks before the birch pollen season with the abm-based extract andosan tm (immunopharma, oslo, norway). this is a water extract of the bacidomycetes mushrooms abm ( %), hericeum erinaceus and grifola frondosa. the participants filled in questionnaires for allergic conjunctivitis & rhinitis, asthma and medication. serum ige (immunocap â , immunodiagnostics, sweden) and bet v -induced basophil activation in whole blood determined by cd expression in a flow cytometer (flow cast â , b€ uhlmann lab ag, switzerland), were analyzed before and after the pollen season. (trial record: nct , clinical.trials.gov). results: there was significant reduction in allover allergy-related ailments and types of allergy medication used in the abm extract compared with placebo group during the pollen season and no side effects. also, abm treated asthmatics had fewer symptoms and used less medication than controls. in the abm group, serum levels of specific ige anti-bet v and anti-t , were significantly reduced during the pollen season as compared with levels in the placebo group. whereas the maximal allergen concentrations needed for eliciting basophil activation before the season changed significantly to lower concentrations (i.e. enhanced sensitization) after the season in the placebo group, these concentrations remained similar in the group given the mushroom extract. summary/conclusions: oral pre-seasonal supplementation with an abm-based extract for months reduced general allergy ailments, asthma symptoms and medication in blood donors with birch pollen-induced allergy and asthma during the pollen season. this was due to reduced specific ige levels and basophils rendered less sensitive to allergen activation. the study suggests that supplementation with abm mushroom extract can have prophylactic effect on aeroallergen-induced allergy and asthma in blood donors. it may therefore reduce such ailments in affected blood donors and impact blood donations in the pollen season. results: dhv started in / / . the data presented in this abstract is till / / . data is collected from total of blood donors ( . % male donors and . % female donors). repeat donors accounted for . % against . % of first time donors. of the total number of donor adverse events recorded, . % ( ) reported for male donors and . % ( ) for female donors when the donor adverse events stratified age-wise, the highest incidence reported in age group - years (male . % and female %). among age group - years, (male . % and female . %), whereas in age group - years, (male . % and female . %) data analysis of total reported and registered donor adverse events, are categorized as hyperventilation ( ), sweating ( ), dizziness (pre-syncopal ), loss of consciousness ( ), vomiting ( ), convulsions ( ), hematomas with re-bleed ( ), nerve irritation ( ) and off-site reactions ( ). many donors showed multiple forms of reactions. summary/conclusions: evaluation of donor side effects helps to improve donation process and donor compliance. most frequently recorded reaction remains dizziness (pre-syncopal). our donor vigilance data show reactions occurred more frequently in younger age, female and first time donors. repeat donation and age are predictors for low rates of adverse events. participation in dhv implies an effort to improve donor care and safety infrastructure and a desire for national and international comparisons to determine best practices and also to look into effectiveness of risk reduction strategies and follow-up trends. pre-donation hydration was implemented as an interventional tool to test the effects of hydration on pre-syncopal reactions to blood donation, specifically targeting those at highest risk such as female, first-time, high school donors. the results are awaited. background: descriptions of deferral categories and a knowledge in the percentage of deferrals in each category are of value in formulating recruitment and retention strategies. this can also help in planning more efficient recruitment strategies and thereby assist in reducing the shortage in blood supply. aims: the aim of the study is to categorize all donors who were deferred during medical checkup and find out the donor deferral rate in dubai blood donation center from january st to december st and also to find out whether there is any yearly or seasonal trend in any of the categories of deferral criteria's which can aid in forecasting and managing donor pool. methods: a retrospective study of donors deferred during last three years from january st to december st was done in dubai blood donation centre. the donors deferred during pre-donation medical check-up were categorized into categories including low hemoglobin, high and low bp, intake of antibiotic, fever and flu, taking other medications, travel history etc. the deferrals were analyzed monthly and yearly and then were compiled to find any yearly trend or seasonal trend in the donor deferral rate in any of the categories. the data were analyzed using the spss software and a p value of < . was considered significant. the assessment of donor suitability is in accordance with aabb standards and is consistently applied in every blood donation setting on each occasion of donation to all blood donors. results: during this study, , donors were registered from january st to december st and , ( . %) donors were deferred. the common reasons of deferral were low hb, high bp, travel history, intake of antibiotics and cough/flu symptoms. there was a significant decrease in deferral rate from . % ( / ) in to . % ( / )in and further to . % ( / ) in (p < . ). the specific deferral rate due to low hb also significantly (p decreased during these three years ( / in , / in , / in ), though no change was seen in the deferral due to other reasons. the reduction in the rate of deferral due to low hemoglobin may-be linked to the change in the staff performing the hemoglobin testing in dbdc (nurses instead of phlebotomist were assigned to perform hb estimation of donors). there was a seasonal variation in the deferral rate in all the three years-lowest in june ( / ) and then increasing with a peak in october ( / ) and plateauing till january. this pattern of deferral corroborated with the rate of deferral due to flu/fever and cough and antibiotics with an average of / in june and increasing to / in october (p < . ). summary/conclusions: staff competency is pertinent in accurately deferring donors. there is also a significant seasonal pattern in flu/fever and intake of antibiotics deferral rate that is reflected in the total donor deferral pattern. seasonal variation of specific category of donor deferral should be taken into account for donor recruitment and retention efforts. background: west nile virus (wnv) is a mosquito transmissible flavivirus. it has been shown (vogels thesis) that the common mosquito in the netherlands can transmit wnv in laboratory circumstances but presently does not lead to effective transmission. however, the number of outbreaks of wnv is increasing and moving from the eastern and southern european borders towards the traditionally more colder western and northern parts of europe. in order to prevent wnv transmission to blood transfusion recipients, dutch donors that travelled to regions with wnv risk are deferred for a period of days for whole blood, platelet donations and quarantine plasma in order to exclude potentially infected asymptomatic donors. aims: to assess numbers of dutch donors who are deferred for travelling to wnv risk areas within europe, and the return after onsite and offsite deferrals of donors. methods: data from to on donation attempts and deferral were retrieved from eprogesa, the blood bank information system. onsite deferral is defined as a donation that was attempted in the deferral period or in the days prior to deferral, all other deferrals are considered as offsite. a generalized estimating equation model was used to assess the association between onsite versus offsite wnv risk deferrals in - and subsequent return rates within two years (after which a donor is inactive according to domaine). results: in - , , donation attempts led to onsite deferral for wnv risk; % at whole blood donation attempts, % at new donor examinations. in total , offsite deferrals could not be traced directly to a donation, but based on the next donation more than % were probably whole blood donors. the number of deferrals peaks each year during august, the major holiday period in the netherlands, and increased from in august to in august . this increase is probably caused by the expansion of wnv risk regions. the return rate of wnv deferred whole blood donors is slightly lower than for donors who are not deferred ( % versus %); for wnv deferred new donors the return rate is % (versus % for no deferral). thus wnv deferral resulted in approximately - extra lapsing donors during these years. however wnv deferred donors, that are older (odds ratio (or) . ; % confidence interval ( % ci) . - . ), of male sex (or . ; % ci . - . ) and whole blood donors as opposed to new donors (or . ; % ci . - . ) were more likely to return to donate. there was no difference in return rate by offsite and onsite deferral. summary/conclusions: travel-related wnv deferrals are increasing with expanding risk regions, especially in the holiday season where the availability of donors is already low. although the numbers of donors who are permanently lost after wnv deferral are limited, the increasing numbers of lost donations make it important to consider alternatives to donor deferral such as wnv nat testing. background: low haemoglobin due to iron deficiency is increasingly recognized as a serious problem in many blood centers. donor education, iron supplementation, ferritin monitoring, and lengthening of inter-donation interval are currently the main mitigation measures. however, a number of factors in particular donor knowledge could impact their success. locally, iron supplementation programme was implemented since with target group of donors who have given blood within the last six months. aims: here we look at an online donor survey to gain insight on their view of the programme and knowledge. methods: donors with successful blood donation in the past six months would be given days of one tablet of iron supplementation ( mg elemental iron) since . an electronic questionnaire was sent to blood donors in to assess their view on the programme and knowledge which focused on iron store and absorption, compliance and any side effects occurred. results: donors (male to female was : . ) replied to the questionnaire. of them, received iron supplementation (male to female was : . ). most of the respondents ( %) had one or more donations in the preceding months. of the donors received iron tablets, only ( %) took all; ( %) took more than % but not all; ( %) took some but less than % and ( %) did not take any. gastrointestinal upset was reported in ( %) donors and constipation seen in ( %) among those who took at least some of the iron supplementation. most respondents answered correctly to the questions on the knowledge on iron store and absorption. when comparing those with better compliance (took more than %) to those who did not (took less than %), significantly more donors in the former knew vitamin c could enhance iron absorption (p < . ). on the other hand, no difference was seen when they were asked if ) iron can only be absorbed from meat; ) tea and coffee consumed during meal can enhance iron absorption; ) everyone can take iron supplementation on their own; and ) iron store in male is always more than female. summary/conclusions: the results suggested that there is definitely more room to enhance the blood donors' knowledge on iron store and absorption in order to improve the effectiveness of iron supplementation programme. besides, the side effects reported by the donors could be an important limiting factor that better alternatives should be explored and considered. background: vasovagal reactions (vvr) are a well-established deterrent to donor return. however, the correspondence between vvr experience and donor lapse is not perfect. in australia, for example, vvrs only reduce two-year return rates by % for whole blood donors and % for plasma donors. the elements of a vvr and the donor's interpretation of this event that protect against or encourage lapse have not yet been identified. aims: in this study we explored the views of donors on donating following a vvr, with a particular interest in their emotional reaction to the vvr, their understanding of what caused the reaction, and their intentions to return. methods: semi-structured telephone interviews were conducted with whole blood and plasma donors who had a recent vvr experience. data were analysed using the framework approach. results: donors are generally motivated to give blood to help others and to positively impact on those in their communities. they anticipate feeling good after their donation but in contrast, for many, a vvr leaves them feeling anxious, embarrassed, and disappointed. for donors, the experience of a vvr negatively influences their perceived ability to donate successfully, and many fear it will happen again. however, this effect appears minimised among donors who at least partially attributed their reaction to their own behaviour, such as poor hydration. for donors already juggling multiple demands, a vvr may tip the balance with donating becoming too much of an effort and perceived risk. however, donors appeared more confident to return if they felt supported by staff or if they could donate with family or friends. summary/conclusions: this study provides valuable insight into the vvr experience, which will aid in the improvement of donor safety and retention. the findings highlight the need to improve communication at the time of and following a vvr, to educate donors on how to reduce their vvr risk, and to intervene to help donors maintain their perceived ability to give blood in order to maximise retention following a vvr. background: frequent blood donation depletes the iron stores of blood donors. iron depletion might have negative effects on the health of the general population, but its effect on the blood donor population is not well known. aims: to investigate the iron status of finnish blood donor population and how it relates to donor health, the finnish red cross blood service set up the findonor , study in . we investigated whether there were changes in donors' selfrated health and if these possible changes could be associated with differences in iron biomarkers (ferritin and soluble transferrin receptor -stfr) or hemoglobin levels during the first study visit. methods: participants were recruited in three donation sites in the capital region of finland between may and december . participants filled out an electronic questionnaire about their health and lifestyle at the donation site during their enrollment visit. participants were asked by letter to fill out the same questionnaire electronically during the summer . we included the participants ( men and premenopausal and postmenopausal women) who completed both health questionnaires. to evaluate self-rated health we used the well-validated single question: "how would you rate your health in general?". participants were able to evaluate their health status on a five-point scale: excellent, very good, good, moderate, and poor. iron biomarkers and venous hemoglobin were measured from blood samples collected at the first study visit. we first computed the odds-ratios of reporting poorer health depending on demographic group. we then compared iron biomarker and hemoglobin levels between donors who reported improved, similar or poorer health rating. results: donors who rated their health in the first questionnaire as moderate (n = ), good (n = ), very good (n = ) or excellent (n = ) health tended to report improved ( %), similar ( %), similar ( %) or poorer ( %) health ratings respectively in the second questionnaire. pre-menopausal women reported their health poorer in the second questionnaire compared to the first questionnaire more often than post-menopausal women (pre-menopausal %, post-menopausal women %), or = . % ci . - . ). there were no differences between other groups. there were no significant differences in iron biomarkers levels (ferritin and stfr) or hemoglobin levels between donors whose health ratings were improved, similar or poorer. summary/conclusions: in this cohort, pre-menopausal women rated their health poorer at the end than at the beginning of the study more often than post-menopausal women. no association was found between changes in self-rated health and iron levels (ferritin, stfr) or hemoglobin levels. further studies about the factors relating to blood donors' self-rated health need to be carried out. background: in recent years, the blood donation business has made great achievements, but it still cannot avoid the occurrence of adverse reactions to blood donation which not only brings certain obstacles to the blood donation work, but also affects the enthusiasm of blood donors. aims: to understood the causes and other relevant factors of adverse reaction among blood donors, the information of blood donors at dai autonomous prefecture of xishuangbanna were analyzed in . methods: the data of volunteers from january to december were analyzed. the causes of adverse reactions were classified, and the incidence of adverse reactions was compared in terms of gender, frequency, age and blood type of blood donors. results: there were blood donors in , ( . %) of whom had adverse reactions and causes were induced, among which mental stress was the most common factor that accounted for . % ( cases). there was no significant difference in the incidence of adverse reactions between men and female (p > . ). from the frequency of blood donation, the incidence in the first donor was significantly higher than that in the second donor (p < . ). when it comes to age, the incidence was different and the - age group was the highest ( . %). among different blood group donations, there was no significant difference (p > . ). summary/conclusions: adverse reactions of blood donation is closely related to the psychological state and age of the blood donors. the staff of the blood center should further optimize the service, strengthen the communication and publicize the knowledge of blood donation. the ultimate goal is to increase the blood donation rate on the basis of reducing adverse reactions. background: blood loss due to repeated blood donation can lead to iron deficiency or anemia, but currently there is no management plan for the prevention of iron deficiency in korean blood donors. female and male donors are required to wait at least weeks between blood donations in korea, which is the shortest period among all northeast asian countries. female and male donors are allowed to donate whole blood up to five times per year and platelets up to times per year (if spaced more than days apart for the latter) due to the chronic blood supply shortage. these facts induce concern about the impact of blood donations on the donors' iron status. aims: this study aimed to evaluate the effect of oral iron supplementation in repeat donors based solely on donation history. methods: the high-risk group included male donors with ≥ whole blood donations or plasmapheresis or plateletpheresis donations, and female donors with ≥ whole blood donations or component donations, both within the previous year. the control group consisted of first-time or reactivated (ft-ra) donors who had no history of blood donation in the past years. the hemoglobin (hb) level, ferritin level, total iron binding capacity (tibc), transferrin saturation, and soluble transferrin receptor (stfr) of repeat donors at high risk for iron deficiency were compared to those of ft-ra donors. iron deficient erythropoiesis (ide) is defined as present if the log of the ratio of soluble transferrin receptor to ferritin was ≥ . . the repeat donors took iron supplements for weeks and the same tests were repeated after and weeks to evaluate their effects and the side effect and compliance was assessed. results: a total of male and female repeat donors were recruited, and each male and female ft-ra donors were recruited to the control group. after week iron supplementation, among male donors, the prevalence of: low hb level (< . g/dl) decreased from . % to . %; low ferritin level (< . ng/ml) decreased from . % to . %; high tibc level (> lg/dl) decreased from . % to . %; low transferrin saturation (< . %) decreased from . % to . %; and ide (stfr/ferritin ≥ . ) decreased from . % to . %. among female donors, the percentage of: low hb level (< . g/dl) decreased from . % to . %; low ferritin level (< . ng/ml) decreased from . % to . %; high tibc level (> lg/dl) decreased from . % to . %; low transferrin saturation level (< . %) decreased from . % to . %; and ide (stfr/ferritin ≥ . ) decreased from . % to . %. in total, male ( . %) and female ( . %) blood donors reported undesirable side effects related to iron supplementation. a total of male ( . %) and female ( . %) blood donors were administered iron supplementations for days. participants ( . %) answered that they were willing to take a complimentary iron supplementation. summary/conclusions: ferritin level, considered a reliable indicator of iron status, increased and ide decreased significantly after iron supplementation in female donor group, but not in male donor group, compared to the ferritin levels and ide of control donors. iron supplementation in repeat donors at a high risk of iron deficiency was shown to reduce their risk of iron deficiency or anemia irrespective of gender; however, -week oral iron supplement was not enough to restore iron storage level in the male donor group. background: c-reactive protein (crp) is an acute-phase protein and a non-specific maker of inflammation and tissue damage produced by the liver. several prospective epidemiologic studies have demonstrated that high-sensitivity c-reactive protein (hs-crp) is a predictor of future coronary events among apparently healthy men and women, hs-crp level greater than mg/l has been independently associated with a % excess risk in incident of coronary heart disease (chd) as compared with levels less than mg/l. frequent blood donation has been associated with a lower incidence of coronary artery disease (cad); however, there is a dearth of information on serum levels of crp in the nigerian donor population. aims: to investigate whether regular blood donation is associated with lower serum hs-crp level in nigerian blood donors. methods: a descriptive cross-sectional study carried out to measure serum levels of high sensitive c-reactive protein (hs-crp) and ferritin among blood donors attending the donors' clinic in lagos university teaching hospital (luth). subjects who did not meet criteria for blood donation were excluded. additional data on sociodemographic characteristics was collected using interviewer-administered questionnaire. serum ferritin was analysed using chemiluminescent microparticle immunoassay performed on the abbott architect ci (abbott laboratories, abbott park, il, usa). serum concentration of hscrp was estimated by immunoturbidimetry method using analytical kits from erba diagnostics mannheim gmbh in semi-autoanalyzer (xl , erba mannheim). data was analysed using stata version (stata corp) statistical software. results: in total of blood donors, ( . %) were males and ( . %) were females, the mean age was . ae . years. two hundred and thirty four ( . %) were first time donors and ( . %) were regular donors, serum levels of hs-crp was slightly higher in regular donors compared to first time donors ( . ae . vs . ae . mg/l, p = . ) though the difference was not significant. serum levels of ferritin was significantly higher in first time donors compared to regular donors ( . ae . vs . ae . ng/ml, p = . ). interestingly, levels of serum hs-crp were significantly higher in male than female population ( . ae . vs . ae . mg/l, p < . ) and smokers than non-smokers ( . ae . mg/l vs . ae . mg/l, p = . ). correlation analysis showed no correlation between serum hscrp and serum ferritin levels in both categories of donors while there was a weak positive correlation between hs-crp levels and white blood cells among the first time donors. summary/conclusions: this present study did not reveal any decrease in baseline levels of serum hs-crp with regular blood donation; smoking status and gender were however associated with an increase in baseline hscrp. this finding suggests that hs-crp level might not be a useful marker of future coronary events in healthy blood donors in nigeria. background: because the blood donation removes mg of iron from the donor, iron deficiency, frequently occurs in regular blood donors leading at a long term to the anemia. aims: to determine the effect of blood donations on ferritin levels in regular blood donors. methods: all prospective donors have been submitted to a physical examination and a health history assessment intended to ensure that the prospective donor is in a good general health and eligible to donate blood. the acceptance criteria are: • hemoglobin > or = . g/dl for male and > or = . g/dl for female • inter donation interval = days • donations/year for male and /year for female all eligible donors and deferred donors for all reasons except for low hemoglobin who accepted to enroll in this study and signed a consent. in addition to the medical exam, two samples have been collected one for cbc and another for ferritin. donation history, sex, age and weight have been documented. results: first time and regular donors accepted to enroll in this study. only female donors ( . %) participated to this study. . % of the participants were first time donor. % of male and % of female frequent donors are iron deficient out of male blood donors were iron deficient ( %) with serum ferritin < ng/ml. . % were repeat donors. out of female donors were iron deficient ( . %) with serum ferritin < ng/ ml, all were repeat donors. . % of repeat donors were iron deficient / of the deplete donors were first time donors summary/conclusions: frequent blood donors have higher prevalence of iron deficiency than first time donors. female donors have a slightly higher prevalence of iron deficiency than male donors. prevalence of iron deficiency in abu dhabi donor population is lower than the published data. changes need to be done on: increase inter donation interval or restrict the total number of allowable donations in a -month period for whole blood and red cells modifying donor hemoglobin requirements testing for serum ferritin iron supplementation donor education abstract withdrawn. background: haemovigilance procedures aim to guarantee not only the safety of the recipients of blood and its components but the safety of the donors as well. every adverse reaction that occurs during the donation of blood or its components can potentially be a threat to the health of the donor which can subsequently lead to the decision of the donor to resign from donating blood. aims: the aim is to analyse the type and the frequency of occurrence of adverse reactions among the donors donating blood or its components independently of the method of the donation. methods: we have analysed the number of collected donations and the number of adverse reactions in the years - in the group donors of aged - . we have specified following adverse reactions: vasovagal response without fainting, vasovagal response with fainting, vascular reactions (bruises) and other (e.g. allergic reaction to the anticoagulant, loss of blood pressure due to hypovolemia). the analysis was made using data obtained from computer system blood bank which is in operation in blood center in pozna n, poland. results: in years - the total number of adverse reactions among the donors was recorded which is . % of the total number of collected donations. % of the adverse reactions occurred in the group of donors aged - . vasovagal response without fainting was the most common adverse reaction in the total number of reactions and totalled . % of all adverse reactions. in the group of donors ages - it totalled % of all adverse reactions. the second most common type of adverse reactions was vasovagal syncope that totalled . %, in the analysed group of donors . %. vascular reactions (bruises) totalled . % of all adverse reaction, in the analysed group . %. the remaining adverse reactions totalled . %. summary/conclusions: . vasovagal reactions (with and without fainting) were proved to be most common adverse reactions in the group of donors aged - i.e. in the groups of donors just starting to donate blood. it seems reasonable to continue with further research into the reasons for the occurrence of this psychosomatic reactions. . it seems beneficial to provide constant educational activities of young donors regarding the preparation for the process of donation of blood and its components (proper nourishment, hydration as well as planning the time for scheduled donation long enough for a safe and pleasant procedure. . it seems beneficial to provide constant training for the medical staff involved in the process of donation regarding active observation of donors, proper conduct in the situation when the adverse reactions occur during the blood donation, ways to minimize the fear of donors, effective communication with the donors (explaining the process of blood donation, proper behaviour after the donation e.g. avoiding physical exercise or straining the arm). blood products -blood processing, storage and release background: the accumulation of microvesicles (mvs) in rbc concentrates during storage may be responsible for clinical symptoms such as inflammation, coagulation, and immunization. aims: our aims was to determine whether any of cd molecules responsible for important functions are present on the microvesicles, and if their expression level is dependent on the storage period of rbc units. additionally, by using cytometric analysis and phagocytosis visualization in a confocal microscope, we examined the interactions of donor monocytes with erythrocyte microvesicles, depending on their time of storage. methods: erythrocyte microvesicles were isolated from "fresh" ( nd day) and "old" ( nd day) stored rbc units. qualitative and quantitative cytometric analysis of these membrane structures was performed using the annexin v-fitc, anti-cd a-pe antibody, and calibrated beads. the microvesicles were also visualized under a confocal microscope. the expression of the molecules cd a, cd , cd , cd , cd , and of phosphatidylserine was analysed using flow cytometry. measurements of microvesicle phagocytosis by human monocytes were carried out using a flow cytometer and a confocal microscope. results: the analysis of the microvesicles with calibration beads allowed us to identify these structures with a diameter of about . lm in the "fresh" and "old" blood samples. we observed a statistically significant increase in the number of microvesicles in the "old" units ( ae mvs per ll), as compared to the microvesicles in the "fresh" ( ae mvs per ll). at day , the microvesicles had elevated expression levels of cd and reduced expression levels of phosphatidylserine. significant changes were also observed in the case of cd and cd molecules. the expression of these molecules of vesicles isolated from "fresh" rbcs was lower than in the case of -day vesicles. the phagocytosis index was significantly higher ( . %) for the microvesicles isolated from -day stored rbcs than for microvesicles from the - background: platelet concentrates (pcs) are conventionally stored at room temperature with a limited shelf-life of - days. alternative storage methods, such as cold storage and cryopreservation are attractive options due to the potential for extended storage, reduced bacterial growth and improved hemostatic function. cryopreservation of human pcs has been associated with formation of more microparticles and elevated procoagulant activity compared to liquid-stored (room temperature-and cold-stored) pcs. microparticles are submicron plasma membrane particles that have been postulated as potential mediators of adverse transfusion outcomes. similarities in the size and storage-related changes up to days suggest that sheep may be a suitable model in which to investigate the effects of pc transfusion. previous research has established that room temperature stored sheep pcs contain fewer microparticles than human pcs. however, nothing is known of the effect of other storage conditions. aims: this study aimed to determine whether cold storage and cryopreservation contribute to variation in concentration and size of sheep platelet derived microparticles compared to conventionally stored sheep pcs. methods: sheep buffy coat derived pcs in % plasma/ % ssp+ were prepared with minor modifications to standard procedures for preparation of human pcs. sheep pcs were split into units (n = of each) on day and stored either at room temperature (rt; - °c with agitation) for days, cold stored for days ( - °c no agitation) or cryopreserved (À °c with the addition of - % dimethyl sulfoxide) for - days and sampled post-thaw. platelet supernatant, prepared by double centrifugation, was stored at À °c. the mean size and concentration of microparticles were measured using nanosight ns nanoparticle tracking analysis system (malvern instrument). results are mean ae standard deviation. storage associated changes overtime were determined using a one-way analysis of variance with bonferroni's post-test. paired t-tests were applied to determine the effect of cryopreservation. a p-value of < . was considered significant. results: at day , sheep pcs had a microparticle concentration of . ae . microparticles/ml with a mean size of . ae . nm. storage duration at rt sheep pcs was not associated with significant changes to microparticle concentration or size. cryopreservation of sheep pcs significantly increased the concentration ( . ae . microparticles/ ml; p = . ) and the mean size ( . ae . nm; p = . ) of microparticles post-thaw. the mean size and concentration of microparticles in the cold-stored pcs at day was comparable to room temperature pcs stored for days ( . ae . nm vs. . ae . nm; p = . and . ae . microparticles/ml vs. . ae . microparticles/ml; p = . respectively). summary/conclusions: cold storage of sheep pcs did not impact formation of microparticles over the days storage period; however, cryopreservation increased microparticle concentration and the size post-thaw. further investigation is required to determine whether these findings are influence hemostatic function. a pre-clinical sheep model of cold-stored and cryopreserved pc transfusions can facilitate mechanistic studies and complement clinical trials. background: during storage, the properties of rbc in storage solution change ("storage lesion"). for instance, ph, atp and , -dpg concentrations decrease upon prolonged storage. these changes can affect oxygen delivery by the cells. the capacity to deliver oxygen is defined as p : the oxygen tension (po ) at which % of the hemoglobin is saturated with o . an oxygen dissociation curve (odc) represents the non-linear relationship between saturated hemoglobin and po . this relationship is dependent on temperature, ph, pco and , -dpg. due to changes in these factors, the curve will shift along the x-axis. in whole blood, p is at a po of about mm hg. not much is known about p of rbcs in storage solution, and the changes during storage. aims: to determine the oxygen dissociation of rbcs stored in standard red cell additive solution sagm and in pagggm (an experimental red cell additive solution, transfusion. ; : - ). methods: rbcs were prepared in sagm (n = ) or pagggm (n = ). pagggm is designed to better maintain both atp and , -dpg during storage. rbcs were stored at - °c and sampled on day , and for (internal) ph, atp, , -dpg and p . p was determined by hemox analyzer (tcs scientific corp.). the principle of the hemox is based on the measurement of spectrophotometric properties of hemoglobin at different oxygen pressure. rbc samples were brought from oxygen-rich environment to oxygen-poor environment ( %) using n gas. p was determined from the obtained odc. results: the whole storage period, ph i of pagggm-rbcs was higher compared to sagm-rbcs. , -dpg content of sagm-rbcs decreased during storage and was below the detection limit after day . , -dpg content of the pagggm-rbcs increased the first days of storage and slowly decreased from day on. at day , pagggm-rbcs still contained . -dpg ( . lmol/g hb). p values decreased during storage from mmhg at day to mmhg at day for sagm-rbc and from mmhg to mmhg for pagggm-rbc. p values of pagggm-rbcs were higher during the entire storage period. summary/conclusions: during storage, the p decreased in all rbcs. the p was higher for the pagggm-rbcs during the whole storage period. the higher p in pagggm-rbcs seems to correlate with the higher , -dpg content in these cells. background: in belgium % of the platelets are pathogen inactivated (pi) and legislation requires a minimum platelet content of . per platelet concentrates (pc). therefore routine pools are produced with buffy-coats (bc). facing increased demand of pc and stable to slightly declining red blood cells (rbc) demand, production of whole blood (wb) derived platelets must be adapted to switch flexibly from to bc per pool. this dual pooling strategy should allow alignment between wb collection forecast, pc inventory, pc demand and pc production. aims: first develop a pooling procedure with bc and ml platelets additive solution (pas) instead of ml for bc, without changing the settings of our wb separators and platelets separators. maintain a content of ≥ . platelets with a ratio plasma/pas between to % required for pi. after validation, deploy a dual pooling strategy ( or bc/pool). methods: wb is collected with top and bottom kit (composelect; fresenius kabi) and separated (macopress; macopharma) to produce ml bc with % haematocrit (htc) and > % platelets recovery with average platelets content of . random bc are pooled with ml or bc are pooled with ml of pas-e, platelets are then extracted on tacsi pl (terumo bct) and pc are treated for pi (intercept blood system; cerus). each pc is sampled and platelet content is determined (abx pentra xl ; horiba). results: during the study bc were processed into pools ( ( . %) with bc and ( . %) with bc). before tacsi separation, bc mixture with pas-e had volumes of ae ml ( bc) and ae ml ( bc) with respectively htc of ae % and ae %. the plasma/ pas ratio was ae % in both cases. tacsi separation was performed with one same program for both types of pools. after pi, platelets content of the pools was . ae . with bc and . ae . with bc (average ae standard deviation). pools below the limit of < . were / ( . %) with bc and / ( . %) with bc. the platelets concentrations ( /ll) were ae ( bc) and ae ( bc). platelets recovery was % ae for bc and % ae for bc. summary/conclusions: bc could theoretically produce pools of bc or pools of bc. this means a maximum potential gain of + % pc. in practice during shortage periods we switched from to bc when dictated by the actual inventory levels and hospital needs. the advantage of this dual pooling strategy was a gain in production capacity to cover these shortage periods ( pc, + %). the disadvantage of pooling randomly bc is that pools contained less than . platelets per pool potentially limiting their usage to low weight or paediatric patients. a preselection of the bc based on platelet count could optimize the bc pooling procedure. background: apheresis-derived platelet concentrates (apcs) is a standard medical therapy indispensable to contrast bleeding or hemorrhage. however, bacterial infection caused by storage at room temperature (rt) still remains the major drawback. recently, we showed that cold-stored apcs are associated with better plt functionality but with accelerated clearance (haematologica , pmid: ). cold-induced apoptosis was identified as a potential mechanism of the shorter plt survival aims: to investigate the protective effect of apoptotic inhibitors during cold storage of apcs methods: apcs were collected and stored at rt and °c in the presence or in the absence of caspase- inhibitor. the phosphatidylserine exposure and the mitochondrial membrane potential (mmp) (tetramethylrhodamine ethyl ester perchlorate [tmre ] staining) were measured using flow cytometry. the protein expression was quantified by western blot results: a higher expression of the apoptotic marker phosphatidylserine was detected in cold-stored apc compared to rt (% apoptotic events meanaesem: ae % vs. ae % p = . ). to verify if the apoptotic signal, observed with phosphatidylserine, specifically involved the intrinsic pathway, the mmp was analyzed as a marker of alive cells. interestingly, after cold storage a decrease of the mmp was observed compared to rt indicating the activation of the intrinsic pathway (mean fluorescence intensity tmre meanaesem: . ae . vs. . ae . , p = . ). accordingly, a decrease of the procaspase- level after cold storage was detected by western blot analysis. however, when plts were stored in the presence of caspase- inhibitor a significant rescue of the cold-stored cells viability was observed (tmre staining: % alive cells meanaesem: ae % vs. ae %, caspase inhibitor vs. ionomycin, p = . ). this indicates that the activation of the apoptotic pathway, induced during cold storage, can be prevented using caspase inhibitor summary/conclusions: our results show that the reduction of cold-stored plt viability can be prevented by a specific caspase inhibitor. consequently, cold storage, associated with a better plt functionality, may become an efficient strategy for apc storage in combination with apoptotic inhibitors background: gamma-irradiation is used to treat red blood cell (rbc) concentrates (rccs) for patients who are immunosuppressed. this treatment is known to damage rbcs and to increase storage lesions. one of the causes of the storage lesions is the presence of oxygen. several studies have shown, based on different strategies to reduce o , a reduction of storage lesions related to metabolism, protein modifications and cell morphology. aims: the present research work investigated the effect of gamma-irradiation on rccs stored under normal condition and hypoxia/hypocapnia. methods: saturation of o (so )-and abo-matched rccs from whole blood donations, leukoreduced and prepared in paggsm (macopharma, france) were pooled and split in two identical rccs within h post-donation. one bag (treated) was submitted to oxygen and carbon dioxide adsorption (oxygen reduction bag, hemanext, usa) for h on an orbital shaker ( rpm) at °cae and then transferred to a storage bag impermeable to gas. the other one (control) was left as it is. the two bags were then stored at °c. a g-irradiation treatment ( gy, gammacell elan, theratronics) was applied at day or and the rccs (expiry dates at day or day , respectively) were stored until day . hematological parameters, glycolytic metabolites, extracellular potassium level, antioxidant power, morphology and deformability were measured. results: starting so values were of . %ae . (n = ) in control and of . %ae . (n = ) in treated bags, and reached . %ae . and . %ae . at day , respectively. as expected, an increase in glycolysis rate was observed during deoxygenation without any influence from the irradiation. potassium levels were identical in treated and control, and reached around mm at expiry with an irradiation-dependent kinetic release. antioxidant power and deformability were identical in both conditions. no difference in hemolysis was observed after irradiation on day and the values stayed equivalent through end of storage (at day , hemolysis (control) = . %ae . , hemolysis (treated) = . %ae . , p-value > . ). when irradiated at day , hemolysis was lower (p-value = . ) in treated rccs at the end of storage (day , . %ae . ) compared to control ( . %ae . ). seven days post-irradiation, two-third of the control rccs were above the limit of . % whereas all the treated rccs remain below the limit. quantification of microvesicles and morphological analysis confirmed these data. summary/conclusions: the storage under hypoxia has a beneficial effect on rbc storage thanks to a decrease in o content and to an improvement of metabolism. this benefit provided equivalent storage when rccs were irradiated at day and was an advantage when irradiated at day . importantly, the results show that combining irradiation with hypoxia/hypocapnia retained the improved hemolysis profile of o depleted rbc. in summary, the reduction of o level in rccs enables a better storage of rcc when a late irradiation is applied. background: in vitro blood circuit machines require a constant monitoring of blood flow rate which have to be maintained at a constant value. also, measuring the hematocrit of flowing blood in such machines is essential for performing real-time diagnostics. recently, acoustophoresis has emerged has a promising blood separation technology capable of replacing centrifugation for the preparation of platelet concentrate. to avoid damaging blood cells, the technique is used without infusing pumps thus increasing the need of flow monitoring. however, acoustophoresis chips performs at low flow rates, outside the range of available commercial flow meters. in addition, hematocrit measurement is of a particular interest for acoustophoresis since it is a direct indicator of the separation efficiency. aims: in this study, we present a straightforward doppler ultrasound system designed for measuring blood flow rate and hematocrit in an acoustophoresis chip [bohec et al, platelets, ] . we show that the stability of the in vitro environment can be used to obtain high level of accuracy of the doppler method using a basic and low-cost experimental set-up. this improvement allows a precise measurement of flow rates as low as . ml/min in sub-millimeter tubing. furthermore we evaluate the capability of the system to measure hematocrit of human blood samples coming from different donors. methods: the experimental set-up was constituted of an ultrasonic continuous wave doppler probe mounted on a d printed support. the accuracy of flow rate measurements between . ml/min and . ml/min was evaluated as well as the optimal measurement time. for different blood bags, the relationship linking the total energy of doppler signals and hematocrit was derived. hematocrit in a range under % was estimated from doppler signals for each blood bag. results: the system is able to acquire exploitable doppler signals for the whole flow rate and hematocrit range. flow rate estimation from the signals shows a high accuracy with a mean measurement error under % for a measurement time of s. the mean error is still under % for a measurement time of . s. hematocrit estimation from doppler signals shows a good linear correlation with reference measurements for bags , and . hematocrit estimation for bag diverges from reference for values above %. summary/conclusions: the proposed doppler ultrasound system is capable of measuring low blood flow rate in narrow medical tubing with a high accuracy. it is particularly suited for an acoustophoresis device but the versatility of the system makes it easily applicable to any in vitro blood circuit. we furthermore demonstrated that the system can be used for measuring hematocrit under % without additional developments. this finds interesting applications in blood sorting technologies but also demonstrates that doppler ultrasound is a potential simple and low cost method for measuring hematocrit of flowing blood in vitro. background: hereditary hemochromatosis (hh) is the most common genetic disorder in populations of northern european descent manifesting with high levels of storage iron (ferritin) in blood and tissues. the standard treatment is serial therapeutic phlebotomy to decrease iron overload. the collected blood is frequently discarded but some blood banks allow "healthy" hh patients to donate blood for patient use. red cell concentrates from hh donors have been reported safe for transfusion, but little or no data is available on platelet concentrates from hh donors, including the potential contribution of surplus iron to the "platelet storage lesion". aims: the aim of this study was to compare platelet quality, activation and aggregation over seven-day storage in platelet-rich plasma from patients with newly diagnosed hh and from healthy controls. methods: whole blood ( ml) was drawn into compoflow blood bags containing cpd and sag-m from healthy controls and newly diagnosed hh patients. platelet-rich plasma (prp) was prepared from whole blood and split into four compo-flex bags each containing ml prp (range - platelets/l). platelet quality tests were performed on days , , , and of storage. platelet aggregation was tested using a chrono-log aggregometer and four agonists (adp, arachidonic acid, collagen, and epinephrine). platelet expression of cd , cd b, and cd p was measured with flow cytometry while ph and metabolites were measured with a blood gas analyzer. scd l and scd p in the supernatant were quantified using enzyme-linked immunosorbent assays. results: both hh and control groups included males and females. the mean age was significantly lower in the control group, years ( - years), than in the hh group, . years ( - years) (p = . ) while ferritin levels were significantly higher in hh patients (median . , range - ) than in controls (median . ng/ml, range . - ng/ml) (p < . ). in the hh group, each had the c y/c y and c y/h d genotypes. results of prp quality control tests were comparable between the two study groups over seven days of storage (p < . ) with the exception of glucose (higher in hh patients on all time points, p < . ). platelet aggregation and the expression of activation markers (cd p and cd b) on platelets and in the supernatant (scd p and cd l) were comparable between hh and control prp units over all seven days of storage. the analysis revealed comparable and expected alterations in metabolic and platelet activation markers over seven-day storage in both groups. ph increased, glucose decreased, and lactate increased over time while cd b expression decreased and cd p increased. platelet aggregation responses decreased during storage but to a varying degree depending on the agonist, however, the decrease was comparable in cases and controls. summary/conclusions: these results suggest that high iron stores in hh do not adversely affect the quality of platelet units produced from hh patients. furthermore, the data also suggest that blood from hh patients, including platelets, can be donated for patient use. background: platelets are often shipped over long distances from collection centres to blood processing centres and subsequently to hospitals. platelet agitation facilitates oxygen transfer, thus promoting aerobic metabolism, and maintaining platelet ph. during shipment, platelets cannot be agitated continuously, which may promote anaerobic metabolism. previous studies have examined the effects of prolonged periods without agitation on apheresis platelets collected in plasma, but not platelets in platelet additive solution (pas). it is therefore important to determine whether platelet quality and function are maintained during prolonged transport or hold time in a shipper. aims: the aim of this study was to evaluate the effects of prolonged storage without agitation on the in vitro quality of apheresis platelets in pas. methods: triple dose apheresis platelets (n = ) were collected using a trima accel platform in % plasma/ % pas (ssp+). after resting for h, platelets were split equally into three components, packed into a shipper and transported immediately to the blood centre. upon arrival, one of the platelet components was removed (< h; t ), and the others remained within the shipper, without agitation. the second component was removed at h post-collection (t ), and the third was removed at . h post-collection (rounded up to h; t ). platelets were tested on day , and post-collection and in vitro quality and function were monitored. data were analysed using a two-way repeated measures anova, where a p-value of < . was considered significant. results: platelets held without agitation for h consumed significantly more glucose than those removed at h or immediately upon arrival (p < . ), even on day post-collection. this was accompanied by increased lactate production (p < . ), indicating increased anaerobic glycolysis. consequently, the ph was significantly lower in t platelets (p < . ), and on average it was . ph units lower than in platelets held in the shipper for h or less. however, the ph remained above . in all components. mean platelet volume was also reduced in t platelets (p < . ), suggesting acceleration of the platelet storage lesion. phosphatidylserine exposure, surface expression of cd p and microparticle generation were significantly higher in the t platelets throughout the storage period (all p < . ), suggesting platelet activation. release of scd p was also increased in t platelets (p = . ), whereas extended storage in a shipper did not affect release of rantes (p = . ). adp-induced activation of glycoprotein iib/iiia, measured by pac- binding, was decreased in t platelets (p < . ), indicating reduced platelet responsiveness to agonist stimulation. additionally aggregation in response to collagen (p = . ) and adp (p = . ) were significantly lower in t platelets, suggesting a decrement in platelet function after prolonged storage without agitation. summary/conclusions: significant in vitro changes were observed in platelets held without agitation for h. these results suggest that the length of time that platelets are held in a shipper should be minimised where possible. background: the shelf-life for platelet products has been restricted to days. this very limited window of time is intended to sustain the quality of platelet and to reduce the risk of bacterial growth. we have recently demonstrated that in suitable platelet bags, the platelet product quality remains high after days of storage. this was proved by examining in vitro, the quality parameters of platelets such as platelet concentration, glucose, ldh, and ph (alexopoulos k. et al., haema, , ) . our new target is to extend this research in extra days of storage. we also want to determine if there is any bacterial development in this period. aims: the goal is to investigate the capability of storage period for platelet units, from to days. methods: in this study, platelets were collected from normal blood donors in the blood bank department of general hospital of patras "agios andreas". a total of ae ml of whole blood was drawn into triple cpd/sag-m top-top bags blood container systems, lmb technologie (gmbh). the platelet concentrates were prepared by platelet rich plasma (prp) method and then they were placed in a platelet incubator with agitator (helmer pc ). samples were drawn aseptically with a needless access coupler (cair-lgl) on days , , and . platelet count was done by ceeldyn ruby (abbott all data shown are reported as mean ae standard deviation (sd). the swirling effect remained positive (+) during the seven days storage period. the bacterial screening was found negative. summary/conclusions: platelet concentration in the bag remained constant between day and day , maintaining platelet yield. the decrease in glucose and increase in lactate, along with the decreased ph, show that the platelets remain metabolically active between days and of storage. the ph remained well within the acceptable range. no bacterial contamination was reported. thus, we conclude that platelet concentrates in these specific bags may be used with an extended shelf life of days. further studies are needed with other platelet bags to confirm our hypothesis. abstract withdrawn. aims: we introduce rt-dc as a fast, robust and unbiased quality control tool for pc, rcc and hpsc. utilizing the interdependency between cell deformation and the molecular state of the cytoskeleton, we demonstrate that rt-dc is capable to assess the quality of blood products. methods: by rt-dc we assessed: i) platelets after storage at °c or room temperature (rt) over days for apheresis pcs in addition to standard in vitro platelet function assays; ii). red blood cells before and after gamma irradiation in addition to hemolysis; and iii) hpsc after cryopreservation with % or % dmso in addition to cell count, and in vitro viability. in addition we compared the regeneration time of patients' platelets and leukocytes after transplantation of hpsc products containing either % or % dmso. results: for pcs standard quality assurance tests did not show a major difference between °c and room temperature storage while rt-dc showed a highly significant difference between both start conditions (day - , p < . and day , p < . ). for red cells, we found by rt-dc no impact of gamma irradiation with gy over the entire storage period of days assessing different rcc. for hpsc, rt-dc showed that cryopreservation in liquid nitrogen resulted in a significant increase in deformation ( . for % dmso versus . for the control without dmso; p < . ). however, this did not differ to high extent whether % or % dmso were used for cryopreservation ( . and . , respectively; p < . ). hpsc viability was lower after cryopreservation using % dmso in comparison to using % dmso. overall, blood cell regeneration is comparable between % and % dmso. summary/conclusions: studying platelet and red blood cell concentrates as well as hematopoietic stem cells under different, clinically relevant, storage conditions our results demonstrate that intrinsic material properties reveal insights into cell function and allow to predict cellular state in a robust way and using small sample volumes. in order to offer more flexibility to the production process, the storage of bcs overnight ( h) has been validated in our blood center. aims: the aim of the study was to assess the platelet quality in platelet concentrates derived from overnight stored buffy coats. methods: whole blood collected at day was separated into plasma, bc and red cell concentrates either at day or at day . bcs were then stored until the pooling step at °c without agitation and pcs were prepared at day by pooling isogroup bcs. seven " h-pcs" were prepared from bcs stored for h (whole blood separation at day ) and six " min-pcs" from bcs stored for min (whole blood separation at day ). standard quality control measurements were performed during the process and the storage. in addition, the quality of the platelets into the prepared pcs was assessed throughout the period of storage by measuring the hypotonic shock response (hsr) and by measuring by flow cytometry the proportions of platelets in apoptosis (marked with annexin v), of functional platelets (marked with cd ) and of activated platelets (marked with cd the changes observed during the -h storage period appear to be limited and compatible with a further pr process using a photochemical treatment (amotosalen and uva) with intercept. summary/conclusions: leukocyte-depleted "double dose" buffy coat platelets with a high platelet content and ready for pathogen reduction can be obtained with the ipp pooling and leukodepletion set developed by kansuk. a storage period of h before applying the photochemical treatment is feasible without significantly altering the biological quality of platelets. methods: dd-bc-pc were prepared with bc and ml of pas (intersol, fresenius kabi (germany) are sterile docked to the octopus harness and combined into a ml pooling bag. the pool is centrifuged and the pc supernatant expressed through a bioflex cs leukodepletion filter into a temporary platelet storage container. the obtained dd-bc-pc were tested within h of preparation and after storage for h in the platelet storage container for volume, platelet content, residual leukocytes (wbc), plasma ratio and biological parameters, ph, po , pco , glucose, lactate, mpv, ldh, p-selectin and swirling. results: the platelet content of dd-bc-pc (n = ) was on average . ae . . in a volume of ae ml. the mean of plasma ratio was % [min: . max: . ]. all pc contain < . wbc [min: <lq; max: . ]. po decreased from ae mmhg after separation ( h) to ae mmhg after h, ph (+ °c) and pco was stable during the same time period. glucose decreased from . ae . mmol/l ( h) to . ae . mmol/l ( h) while lactate increased from . ae . mmol/l ( h) to . ae . mmol/l ( h). the vpm was stable with . ae . at h and h. ldh increased from . ae . u/l at h and . ae . u/l at h as p-selectin . ae . ng/ml at h and . ae . ng/ ml. all units have maintained swirling. the changes observed during the -h storage period appear to be limited and compatible with a further pr process using a photochemical treatment with intercept. summary/conclusions: leukocyte-depleted "double dose" buffy coat platelets with a high platelet content and ready for pathogen reduction can be obtained with the platelet pooling and leukodepletion set developed by fresenius. a storage period of h before applying the photochemical treatment is feasible without significantly altering the biological quality of platelets. background: the irish blood transfusion service (ibts) is the statutory body with the responsibility for ireland's national blood supply. in the ibts collected , whole blood units and performed , platelet apheresis procedures. blood is collected in three fixed and six mobile sites and is returned overnight in temperature controlled vans to a single processing site. in september , the ibts implemented the tacsi automated system for the preparation of buffy-coat derived platelets as an alternative to the orbisac system. aims: the aim of this study is to compare operational aspects and quality data of buffy-coat derived platelets prepared by the tacsi (t-pcs) and orbisac (o-pcs) automated systems. methods: qc data of t-pcs and o-pcs from years to were analyzed. in , the ibts prepared , orbisac platelet pools of which , were qc tested. in , orbisac and , tacsi platelet pools were prepared and tested. in , tacsi platelet pools were prepared of which were qc tested. qc data comprised pc volume, platelet content ( /unit), residual leucocyte content ( /unit) and ph at expiry. feedback from the processing laboratory operators was collected comparing operational aspects of preparation of t-pcs and o-pcs. results: from the , o-pcs tested in and , mean pc volume was ae ml. initially the t-pcs mean volume was ae ml but more recently the volumes were increased by addition of a larger volume of additive solution to ae ml. platelet content ( /unit) was significantly improved in t-pcs ( ae ) compared to o-pcs ( ae ) [p < . ] as well as residual leucocyte content ( /unit) which was lower in t-pcs ( . ae . ) compared to o-pcs ( . ae . ) [p < . ]. ph at expiry was lower in t-pcs ( . ae . ) compared to -pcs ( . ae . ) but remained within the quality requirements. from an operational perspective with two tacsi devices, five operators produce approximately t-pcs per hour compared to a lower throughput of o-pcs per hour with five orbisac devices. the tacsi system is more compatible with batch processing which aligns with our staffing arrangements in routine production and has resulted in greater productivity since its introduction. with tacsi implementation, we reverted to manual pooling of buffy coats and new staff had to undergo training to achieve optimal platelet recovery. once staff were trained during validation, we observed a % increase in platelet recovery. processing laboratory staff indicated that tacsi devices were easier and simpler to maintain in comparison to orbisac, but highlighted that some improvements to tacsi system boxes could be made to make the system more robust. summary/conclusions: pcs prepared with tacsi and orbisac automated systems both met national and european quality requirements, however we observed a significant improvement in quality markers of pcs prepared with tacsi. processing staff reported easier maintenance and processing with tacsi compared to orbisac. throughput is higher with tacsi and there is greater additional capacity to increase production in the future if required. a perez aliaga , f puente , a aranda , j domingo , l call en and a bah banco de sangre y tejidos de arag on, aragon, spain terumo bct europe n.v., zaventem, belgium background: the blood bank and tissues of arag on (bsta) is responsible for the collection, processing and distribution of blood in the region of aragon in spain. with five fixed and five mobile sites, the bsta collects and processes , whole blood units per year. to improve quality of processed units and working conditions of personnel, the bsta decided to implement the reveos automated system. validation studies were carried out in november and routine use started in july . in parallel, the bsta initiated pathogen inactivation of platelet concentrates (pc) in november to improve transfusion safety. in november , the mirasol prt system was implemented due to simplicity of this platform. aims: the aim of this abstract is to (i) describe the results of the validation studies carried out during reveos implementation (ii) present routine use data of products processed with reveos and (iii) provide information on mirasol implementation. methods: in , whole blood units were processed using reveos. quality parameters for red cell concentrates (rcc), such as: hemoglobin (hb), hematocrit (hct) and volume; plasma: volume and residual platelet content; and pcs: volume and yield, were analyzed. a control group consisting of units processed with a semiautomated platform was used as comparison. a survey was sent to the collection and processing staff for feedback on operational aspects of the use of reveos. from to , qc data of rccs (n = ), plasma (n = ) and pcs (n = ) processed with reveos were collected. number of mirasol treated pcs and hemovigilance data from to were collected. results: volume, hb and hct of rccs processed with reveos were significantly higher compared to control rccs (volume: ae ml vs ae ml; hb: . ae . g/ unit vs . ae . g/unit; hct: . ae . % vs . ae . %). control plasma units had higher volume ( ae ml) and lower residual platelet content ( ae /l) compared to reveos plasma units (volume: ae ml; residual platelet content ae /l). for pcs, volume was higher for units processed with reveos compared to control ( ae ml vs ae ), but no statistical difference was observed in platelet content (reveos: ae /unit; control: ae . /unit). we observed either an increase or stabilization in qc parameters of rccs, plasma and pcs during the years routine use of reveos. for example, percentage of rccs units hemolyzed dropped from % to % between and and platelet content in pcs increased from /unit (first six months in routine) to /unit. plasma volume increased from ml during validation to ml in . survey results from staff highlighted the user friendliness of the reveos device. number of mirasol treated pcs increased from % in to . % in with no pathogen transmission nor serious adverse events reported following transfusion of these products. summary/conclusions: with implementation of two user-friendly systems, the reveos whole blood automation system and mirasol prt system, we observed an increased standardization of our processes enabling us to provide higher quality and safer blood products to hospitals and the patients they serve. background: white blood cells (wbc) may be regarded as contaminants in blood components and potentially reduce transfusion safety. there is currently enough evidence showing that wbc reduction through pre-storage filtration reduces the incidence of three major complications of allogeneic blood transfusions: febrile nonhemolytic transfusion reactions (fnhtr), refractoriness to random-donor platelet transfusions and transmission of cmv. leukodepletion is now mandatory in canada and several european countries. aims: the aim of this study was to evaluate leukoreduction performance and the quality of the resulting red blood cell concentrate (rbc) produced with new quadruple system top & bottom imuflex crc with an integrated red blood cells filter which was used in whole blood fractionation under routine conditions of san paolo asl blood bank methods: twenty-seven whole blood donations ( ml) were collected with using quadruple blood bags top & bottom system with an integrated rbc filter (imuflex crc, terumo bct). centrifugation and processing (using t-ace ii + -terumo bct) of whole blood units followed the blood bank sop to obtain rbcs, plasma and buffy coat. rbcs were diluted with sagm ( ml) and then filtered by gravity in average - h after blood collection to obtain leukoreduced rbc. average temperature during filtration was °c. samples were collected before and after leukoreduction for calculation of hemoglobin loss through the filtration process. filtration time was recorded. final hb, hematocrit (hct), residual platelets and white blood cells were determined after filtration using standard laboratory methods (blood cell counter) results: wb donations (n = ) were performed. rbc characteristics post-filtration and separation were as follows: volume ( . ae . ml), hematocrit ( . ae . %) hemoglobin ( . ae . g/dl) and hemoglobin per unit ( . ae . g); residual platelets ( . ae . x ³/ll); residual wbcs ( À . ³/ll). the mean filtration time was ae min and no filter blocks were observed summary/conclusions: the usability and performance of the new quadruple system top & bottom imuflex â crc with integrated rbc filter was evaluated. all quality parameters complied with italian and european guidelines and requirements. in conclusion, the set was found to be a reliable and efficient collection and separation system that performs consistently background: novel devices for automated whole blood processing (reveos tm terumo bct) have been installed in regional center for blood donation and blood treatment in katowice to modernize and automate production of blood components. this system allows to separation of four whole blood units into four buffy coat depleted red blood cell concentrates (rbc), four units of plasma and four interim platelet concentrate (ipu) units in one automatic cycle. an ipu is the starting blood component for the production of pooled, leucoreduced platelet concentrates (lpc). residual leukocytes (wbc) are obtained as a byproduct and discarded. the use of this system shortens production time because it combines otherwise two separate steps: centrifugation and blood separation in press. aims: to evaluate the quality of the blood components obtained with the newly developed reveos nlr kits, which are a whole blood collection kits containing no leucocyte reduction filter for the rbcs. methods: blood [wb] was collected into nlr reveos set (terumo bct), and processed between and h from collection using the c protocol. quality control was performed on rbc, plasma and ipu. rbc were tested for hemoglobin (hb) content, hematocrit (ht), residual white blood cells (wbc), volume and hemolysis level on the last day ( nd day) of storage. the content of wbc and platelet count (plt), protein, factor viii on the day of production and after one month of storage were determined in plasma. for ipu, platelet and leucocyte counts, volume and average platelet yield index (pyi) were displayed at the device after processing was recorded. furthermore, a comparison between fully automated and semi-automated whole blood processing was done, by comparing the amount of time necessary to fractionate whole blood units using the two different processes. background: direct, single step automatic blood separation devices (reveos tm terumo bct) was installed in regional center in katowice in . the system allows for full automation of whole blood fractionation. one of produced blood components is an interim platelet unit (ipu), containing most of the platelets and limited of white blood cells (wbcs). it is then pooled through a filter to form a therapeutic unit of leucoreduced platelet concentrate (lpc). a rough estimate of the platelet yield in the ipu, the so-called platelet yield index (pyi) is calculated and displayed by the device after the end of the separation phase. it is a useful tool to optimize selection of ipu for pools to produce lpc. aims: to determine the quality of polled lpc obtained on the basis of ipu from whole blood processed up to h after collection and the usefulness of this method in daily practice. methods: ipus used for production of lpc were obtained using fully automated whole blood processing single step system -reveos tm (terumo bct). from the beginning of the application of the method, therapeutic units of lpcs were produced after overnight hold: pools of ipus and of ipus were made using platelet pooling set (terumo bct), using ml ssp+ solution (macopharma). results: therapeutic units of lpc were analyzed. the mean volume of lpc was ae ml, platelet content was . ae . x , and white blood cells (wbc) count was . ae . x , % all lpcs had wbc below . ph measurements were made on the fifth day of storage, the ph was determined in units of lpc and was . ae . . summary/conclusions: the use of interim platelet units in daily practice increases the possibility of producing high quality blood components for patients and is a great alternative to the laborintensive manual methods of lpc's production. background: the development of cold-stored platelets has been hampered by the rapid removal of blood after transfusion by apoptosis and desialylation due to platelet storage lesions caused by refrigeration. previous studies have shown that antioxidants inhibited the activation and desialylation of cold-stored platelets for days and also inhibited rapid elimination after transfusion in animal models. aims: it was tried whether in long-term ( days or longer) storage conditions, antioxidants showed similar effects inhibiting the activation and desialylation of cold-stored platelets. methods: platelet-rich plasma (about ml) were obtained from a healthy blood donors of type o blood group and divided into a ml platelet storage bag manufactured by the manufacturer, and the conditions including room temperature and refrigerated condition and various kinds of antioxidants were prepared, (ph, glucose, lactic acid) and activation index (cd p, gpiba (cd b), annexin v), degree of reactive oxygen species and sialidase activity on the th, th and th day, and phagocytosis using the hepg cell line and platelet recovery after in vivo transfusion using scid mice were compared and compared. results: cold-stored platelets showed autoaggregation on the nd day of storage, and apparent aggregation on the fifth day of visual observation but not in the antioxidanttreated group. as expected, the ph, glucose and lactate levels of the cold platelets were maintained and the platelets at room temperature changed significantly. nac (n-acetylcysteine) -treated platelets were less active on day and sialidase activity was maintained lower than that of control group on day . the degree of phagocytosis by the hepg cell line remained at the same level during the storage period, and the in vivo recovery rate in the animal model was superior to that of the antioxidanttreated cold platelets for h and h after transfusion. summary/conclusions: cold platelets could be developed as clinically effective agents for up to two weeks if appropriate preservatives were added, and antioxidants, especially n-acetylcysteine, were effective. background: the reveos c procedure produces the following three blood components for transfusion: plasma, rbcs, and a single interim platelet unit (ipu). whole blood is collected into the reveos blood bag set and held at room temperature a minimum of h before processing on the device. after processing on the reveos device, the plasma product is ready to freeze. the rbc product is ready to combine with sag-m additive solution and leukoreduce using the integrated leukoreduction filter. the ipus are rested and agitated for the recommended time. for example, when whole blood is processed within h of collection, the ipu is agitated overnight before pooling. because the ipu is made from one unit of whole blood, approximately to ipus are pooled together and leukoreduced by filtration prior to storage in a platelet storage bag. this leukoreduced platelet pool ( units) can be supplied to the demand of hospitals like a platelet apheresis product. aims: to assess the usability of the reveos automated blood processing system to collect units of whole blood and to process the units on the reveos device, producing blood components that meet product quality specifications. methods: this study will evaluate approximately units of whole blood using the reveos system and approximately units of pooled platelet products. a total of units of whole blood (wb) have been collected into the reveos blood bag set and then held at room temperature without the use of an active cooling system (or temperature control system), such as cooling plates, or in this case, ice packs. of the units, units have been processed on the reveos device using the fresh procedure (within h of collection). nine units have been processed using the overnight wbhold procedure. all units have processed successfully without alarms, resulting in three components (rbcs, plasma, platelets). we also evaluated four platelet pools created from eighteen interim platelet units (ipus). one ipu has been discarded due to a -min whole blood collection time. the leukocyte count on all component using the automatic sysmex-xn cell blood counter. results: the red blood cells meet the criteria for hematocrit, hemoglobin and residual wbc counts are less than million per unit. the plasma units meet the criteria for displayed volume accuracy compared to measured volume and also for factor viii levels. the average residual platelets in plasma levels meet the criteria. the platelet pools meet the acceptance criteria for platelet yield and volume. limited data (n = ) suggests that this criteria will be easily met, provided that wb hold conditions are suitable for platelets. summary/conclusions: final results indicate that products produced from the reveos system meet or exceed product quality expectations. staff report that the reveos system is very easy to use. abstract withdrawn. background: thorough manual mixing of overnight-held whole blood (wb) units prior to centrifugation to separate red cell (rc) from platelet-rich-plasma (prp) is currently practised at the hong kong red cross blood transfusion service (hkrcbts). the mixing step is crucial to maximise platelet yield but laborious, and may cause elbow and wrist injuries in operators. a laboratory shaker, reax (heidolph instruments, schwabach, germany), originally designed for mixing solvents, was modified to allow mixing source wb units by the supplier. to enhance the well-being of the operators in the context of occupation health and safety (oh&s) management, feasibility of the application of such blood mixer to replace the manual mixing steps in blood component preparation was explored. aims: to evaluate the in vitro quality control (qc) parameters of the blood components prepared with the use of the modified mixer. methods: fifty-eight wb collections, including units in ml quadruple bags ( q) with/without integrated leucofilter and units in ml quadruple bags ( q), were processed in accordance with hkrcbts' prevailing component processing protocols except using the motor-driven mixer in lieu of manual mixing. wb collections were divided into groups, mixed at revolutions per minute (rpm) for min (n = ) and min (n = ), then processed into rc, prp platelet and plasma components. in vitro qc assessments including haematocrit (hct), haemoglobulin (hb) and haemolysis at expiry for rc; absolute platelet count and ph for platelet concentrates (plt); volume and residual platelet count for plasma units were evaluated and compared. results: all components derived from both q and q processed with the blood mixer fulfilled the qc requirements stipulated by aabb standards and council of europe (coe) guidelines. there were no significant differences for all the qc parameters in rc and plasma components produced when mixed for or min. summary/conclusions: the overall performance of blood components processed with the motor-driven mixer met the acceptance criteria at the hkrcbts in accordance with the aabb and coe standards. higher platelet yield was observed with prolonged mixing for min. however, prolonged mixing will much delay routine component processing. further evaluation on intermediate mixing time such as , or min may help determine an optimal mixing duration to maximise platelet yield without compromising processing workflow. to conclude, using the modified blood mixer to replace laborious manual mixing in components preparation is promising to improve the oh&s for blood component preparation operators. background: leukocyte reduction is widely used to reduce the risk of non-hemolytic febrile transfusion reactions and alloimmunization by multiple blood transfusions. around and after year , universal leukocyte reduction was adopted in many developed countries. there are mainly two types of filter, one to filter whole blood and the other to filter red cell concentrate (rcc) used during pre-storage blood processing. aims: in this study, we conducted the filtration tests with sepacell tm rs for rcc in comparison with sepacell tm r-s and sepacell tm pure rc widely used in the world. background: the cardarelli hospital blood bank processes over , whole blood units yearly. in order to constantly cope with the huge demand for platelets from oncohematology and intensive care departments, a progressive review of the processing protocols for platelet concentrates (pc) from buffy-coat (bc) pools has recently been implemented to reduce the number of units assembled, from (routine in italy) to . the -bc pc units have slightly lower volume and plasma content, factors that further limit the transfusion risk. in addition, the -bc assembly allows to facilitate the production of the pc units obtained from the same blood type, in order to minimize both the adverse reactions related to the abo/rh incompatibility and the amount of bcs not used. finally, the described innovation also impacts on the workload, with reduction of assembly, centrifugation and separation time. aims: the aim of this work is to define an optimized protocol for the preparation of pc units from -bc pools, so that the platelet yield is always higher than the minimum value required by current regulatory ( . cells/unit). background: blood is a basic component for human life and hence blood transfusion is an integral intervention in the treatment of patients. the need of blood transfusion is increasing with decreasing blood supply due to limited blood donations. conversely wastage of blood products is also a topic for discussion. to ensure the availability of blood products when they are needed, wastage of blood products should be controlled and minimized. aims: the study was designed to investigate the quantity and reasons of wastage of blood products at our hospital. methods: this was an observational study based on the statistical data available from blood bank department of nibd and bmt, pechs campus, karachi, pakistan. the study period was from february to february . study was approved from institutional review board. for all the blood products wastage and reasons of wastage were evaluated. frequencies were calculated by using spss version . results: a total of blood products were available at our institute including each of platelets, pack red cells and fresh frozen plasma(ffp). the overall wastage rate was . %. pack red cells and platelets were fully consumed yet shortage of supply was observed. however, highest wastage was observed in ffp in our blood bank i.e. ( %). results of investigating the common causes of blood product wastage at the hospital revealed that it was highly associated with common causes, including the expiry of unused products ( %) followed by broken bags ( %). summary/conclusions: this study showed over all diminutive wastage rate. ffp wastage was highest among all the blood products. wastage of blood products is a genuine issue in a hospital setup, strategies and plan of action should be discussed and implemented including enhanced collaboration with other centres to outsource the blood products or even donate at times, education and training of staff for better clinical use of blood products and ensure the availability when and where they are needed most. background: in the early s, the blood service of the republic of kazakhstan functioned along the lines of the soviet period: donation of blood was approached to the place of its use (carried out at hospitals), screening of donor blood was carried out at one stage (enzyme immunoassay) on analyzers of semi-automatic type, there was no mechanism calculating the cost of blood components, the activity of blood centers was funded at the rate of liter of whole blood. donation was not popular in society, household fears of infection were common when donated. aims: research objective is to study the main stages of reforming of blood services of the republic of kazakhstan (rok). the research methods are based on the system analysis of the condition of the rok's blood services based on the indicators of production activity for the period of - . results: in order to effectively reform the blood services, the following steps were taken. the blood supply was centralized and optimized. blood collection at hospitals was terminated, more than blood collection subjects were closed. the result was a more efficient use of technical, human and financial resources, as well as ensuring the high quality of the blood components produced. today, there are blood centers in the republicone for each of the administrative territorial units of the republic. the screening of donor blood for transfusion infection markers has been transferred into a two-step principleimmunological analysis and nat testing. a fully automated analytical equipment of a closed type is used for screening, unified for all blood centers of the republic. unification of the equipment choice allowed to provide centralized service maintenance of complex equipment and its uninterrupted operation. since , the national reference laboratory has been operating in the blood service, which conducts an external assessment of the quality of laboratory research in blood centers, as well as research in controversial and complex cases. introduced pathogen inactivation of platelet concentrates in % of cases of platelets. erythrocytes are used only in the weighing solution and only after leukoreduction. the use of resource-saving blood harvesting technologies, as well as methods to further enhance the infectious and immunological safety of components, are expanding annually. the foundations for the development of applied scientific research in the field of transfusion medicine were laid, and an own school of transfusiologists was created. as a result of reforming the blood services, the mechanisms of reimbursement of blood services costs from the budget of the republic have been changed, uniform tariffs have been defined by type of blood components for all blood components suppliers in the country. summary/conclusions: the transformations made it possible to create a blood service in kazakhstan that corresponds to the best international practice and ensures the quality, efficacy and safety of transfusion therapy. further development of the blood service is aimed at deepening reforms, studying and developing cellular technologies, new properties of plasma blood components, and improving the clinical practice of using donor blood components. background: reconstituted platelet concentrate (rpc) is a component that contains platelets (thrombocytes) resuspended in plasma that is blood group compatible with the recipient. it is used when transfusion of platelet concentrate is necessary but the fresh platelet concentrates of the specific blood group are not available. group rh-(negative) platelets resuspended in the ab group plasma are of universal use as such components can be used for all recipients independently of their blood group. in the area of activity of regional blood center in poznan rpc is used most often for patients after stem cell transplant incompatible with their blood group. aims: the aim of the analysis is to evaluate the loss in the number of platelets in the reconstituted platelet concentrates in order to determine their quality and usage. methods: we used for the analysis units of pooled platelet concentrate derived from buffy coats and units of pooled platelet concentrate derived from the apheresis. for the reconstitution group ab plasma was used. we investigated the number of platelets prior to and after the reconstitution. following measures were calculated: number of platelets in pooled platelet concentrates derived from buffy coats, number of platelets in pooled platelet concentrates derived from apheresis; average values and the standard deviation as well as the loss in number of platelets due to the reconstitution. the number of platelets was calculated with impedance method using horiba pentra xl analyser. . pooled platelet concentrates derived from buffy coats the number of platelets before the reconstitution: . /unit ae . the number of platelets after the reconstitution: . /unit ae . the loss in the number of platelets: . % . platelet concentrates derived from apheresis the number of platelets before the reconstitution: . /unit ae . the number of platelets after the reconstitution: . /unit ae . the loss in the number of platelets: . % summary/conclusions: . reconstitution results in the loss of . % of platelets in comparison to the initial value of pooled platelet concentrate derived from buffy coats. . the average number of platelets after the reconstitution is . /unit, which fulfils the quality requirements. . reconstitution results in the loss of . % of platelets in comparison to the initial value of pooled platelet concentrate derived from apheresis. . the average number of platelets after the reconstitution is . /unit, which slightly deviates from the quality requirements. . the results that we obtained show that the process of reconstitution always results in the loss of number of platelets and that the quality of platelet concentrates that have not been reprocessed is always higher. because of that we recommend that the reconstitution should only be performed in special cases such as for patients after stem cell transplant incompatible with their blood group and that hospitals should be supplied with platelet concentrates derived from buffy coats and apheresis. methods: pf was extracted from human pcs by using immunoaffinity chromatography and specific anti-pf antibody on the column. hereafter, pf was purified with concentration tubes having kda molecular weight cut-off and dialyzed via dialysis tubing with . kda cut-off. pf concentration was measured by bradford method. specific enzyme-linked immunosorbent assay (elisa) and dot blot analysis were used to determine the pf specificity. molecular weight of obtained pf was determined by polyacrylamide gel electrophoresis (page). results: our data confirmed clearly that separated pf had kda molecular weight which is corresponding with a tetramer pf . in addition, elisa showed that the pf qualified true antigenicity. dot blot analysis helped us to assure the specificity of pf . summary/conclusions: we used and optimized a homemade protocol to isolate and purify the pf . nevertheless, there was no any scientific report among the databases that utilized the similar purification method. recombinant pf is more feasible and ready-to-use, but its price may discourage the researchers to study the biology of pf . unused human pcs and specific anti-pf antibody can considered as an alternative to separate the pf particularly in labs with the shortage of resources. background: whole blood is increasingly used in civilian hospitals as an alternative to blood components in trauma resuscitation with massive bleeding. however, the hemostatic effect of whole blood depends on the initial platelet content and decreases rapidly within the first weeks of storage at °c. consequently the problem arises of how to provide wb to trauma centers without losing valuable low titer group o units if the units are not used within the expiry date of use. aims: to assess the in-vitro quality of red cell concentrates (rcc) produced from days cold stored leucodepleted whole blood units filtered with a platelet-sparing whole blood filtration filter in order to save the rcc once the wb units has reached the expiry date. methods: units of whole blood were leucodepleted within h using a platelet sparing filter (imuflex wb-sp/terumo bct) and stored for days at ae °c. on the th day of storage, units are centrifuged and the rcc is supplemented with sag-m additive solution for an additional storage of days at ae °c. in vitro parameters such as hemoglobin, hematocrit, residual leucocytes, platelet content, hemolysis, glucose, lactate, atp, . dpg were tested during storage. results: the imuflex wb-sp provided satisfying leucodepletion of the wb units ( . ae . . e /u)) while maintaining % of the initial platelet content ( ae . e /u). mean volume ( ae ml), hemoglobin content ( ae g/u) and hematocrit ( ae %) was within conformance range. after days of storage, % of the initial platelet content at collection is maintained and mean hemolysis is . ae . %. rcc processing at day was uneventful, without loss of hemoglobin or noticeable hemolysis. mean volume ( ae ml), hematocrit ( ae %), hemolysis ( . ae . %) were in conformance with mandatory standards at day . after days of storage (i.e. day after collection), rcc quality parameters were maintained with however an increase in hemolysis ( . ae . %) which was above usual values routinely observed with rcc produced from day processed units. rcc out of were above the maximum limit of . % at day after collection such increased hemolysis was more pronounced at day after collection ( . ae . %) with a proportion of rcc with a non-conforming hemolysis ratio above the accepted threshold ( % of the tested units). summary/conclusions: rcc units can be readily obtained from leucodepleted wb units with spared platelet contents after days of cold storage. in vitro quality attributes of such rcc are within conforming ranges for hemoglobin, hematocrit, volume and hemolysis. hemolysis increases more rapidly than in standard rcc, thus limiting the possibility of use within days after collection. additional studies are being initiated to reduce hemolysis during storage. g hetland , , f mahmood , l nissen-meyer and i nentwich immunology and transfusion medicine, oslo university hospital immunology, university of oslo, oslo immunology and transfusion medicine, akershus university hospital, lørenskog, norway background: allergen-specific ige in donors' plasma can be transferred from blood donors to recipients via plasma-containing products and consequently sensitize recipient's effector cells bearing receptors for ige (mast cells, basophils, thrombocytes etc.). these cells can then degranulate after exposure to allergen. this can cause allergy symptoms of various degrees (johansson, allergy, ) . food allergen-specific ige antibodies, although causing mild or no symptoms in blood donors, can be of clinical importance to plasma recipients due to varying sensitization and activation grade of recipients' effector cells. aims: the aims of the study were ) to assess sensitization profiles against an array of allergens in randomly selected blood donors and ) to identify donors with high concentrations of food-specific ige antibodies that could bear risk of clinically important sensitization of plasma product recipients. methods: we tested serum samples from blood donors randomly selected on one donation day outside the pollen season. we used ll serum per sample in a multiplex ige line-blot enzymoimmunoassay for analytes (euroline atopy screen, euroimmun, germany), which comprised food allergen extracts and single allergens, inhalant allergen extracts, insect venom extracts and one carbohydrate allergen ccd. this high-throughput method enables scanning of serum samples for ige against allergens in less than h. results are expressed as east (enzymoimmunoassay) classes: class (no sensitization), - (weak sensitization), (moderate sensitization), - (strong and very strong sensitization). results: east class, allergen, number of samples. food allergens: class none detected. class , sesame seed: . class , apple ; hazelnut . class , apple ; almond ; hazelnut ; sesame seed ; soybean ; cow milk alpha-lactalbumin . class : donors weakly sensitized to one or more allergens as kiwi, apple, almond, hazelnut, sesame, soybean, wheat, mutton, beef, cow milk beta-lactoglobulin and alpha-lactalbumin. we did not find any donors sensitized to apricot, peanut, rice, rye, yeast, cow milk casein and carbohydrate allergen ccd. insect venoms: class , and none, class , wasp venom ; honey bee . lower classes ( - ) not reported in this abstract. summary/conclusions: we found considerable sensitization to inhalant allergens but such sensitization probably represents low risk of clinical allergies due to passive transfer of antibodies. sensitization to insect venoms was negligible. we disclosed only one blood donor ( %) with high ige to sesame seed with a potential to transfer clinically relevant ige antibodies via plasma products. the need for a broad screening of donors for ige sensitization remains still questionable. background: the platelet storage lesion (psl) is one of the key factors that limit the platelet shelf-life to days. the mechanisms mediating the psl are not well understood, but it is becoming increasingly evident that platelets from some donors do not store as well as others. similarly, assessment of many in vitro quality parameters has been used to predict transfusion outcomes, with varying degrees of success. donor attributes such as age, and body mass index (bmi) may contribute to these differences. aims: to characterise the variability in the quality and function of apheresis platelet donations and to examine associations between donor attributes and platelet characteristics. methods: apheresis platelets (n = ) were collected, stored at °c with agitation, and tested at day , day and post-collection. vwf and fibrinogen binding (indicators of platelet adhesion; ae ristocetin stimulation), phosphatidylserine (ps) exposure (annexin v binding) and microparticles (cd + /annexin-v + ) were measured by flow cytometry. platelet aggregation was initiated with collagen, thrombin or arachidonic acid. thromboxane a (txa ) was measured by elisa. the proportion of procoagulant platelets (% coated platelets) was assessed by fibrinogen binding following collagen/thrombin stimulation. platelet-attached glycans were measured using flow cytometry and lectins ricinus communis agglutinin- (rca- ; detecting galactose-residues) and wheat germ agglutinin (wga; detecting sialic acid and nacetyl-d-glucosamine, glcnac-residues) ae stimulation with ristocetin. donation time, donor age, blood pressure (bp) and bmi were recorded. linear regression was performed using graphpad prism software. results: for many of the parameters measured, there was high inter-donor variability. platelets from subsets of donors showed up to -fold higher vwf and fibrinogen binding, formation of coated platelets and microparticle numbers. binding of lectins was also highly variable between the donors, indicating variability in sugar cleavage. following ristocetin stimulation, binding of all lectins increased, and again there was high variability in the responses, with up to -fold higher binding in platelets from a subset of donors. of particular interest, aggregation in response to arachidonic acid was observed in only % of platelet donations tested; although platelets from non-responders aggregated in response to the collagen and thrombin. txa was also higher in the arachidonic acid responders (p = . ). there were few associations between platelet parameters and donor attributes, and these associations were typically weak. ph at day was weakly associated with donor age (p = . , r = . ) but not bmi (p = . , r < . ), with a trend towards lower ph in younger donors. summary/conclusions: these data indicate that apheresis platelet products are highly variable. whilst donor characteristics may have some influence on the quality of the donated platelet product, there is a high level of inherent inter-donor biological variability. a much larger sample size is required to confirm these findings, and determine whether they have clinical implications. background: the frequency of beta thalassemia mutations, and thus, of beta thalassemia heterozygotes (b-thal-het) is particularly high in certain geographical regions. it has been reported that a significant proportion of donors (occasionally more than %) are b-thal-het that meet the criteria for blood donation (hb > . g/ dl). red blood cells (rbcs) of b-thal-het donors are characterized, in vivo, by particular geometry and redox status. despite sporadic indications that the rbc storage lesion may be milder in b-thal-het, targeted research on this donor group is still missing. aims: the aim of this study was to investigate whether b-thal-het rbcs storage at blood banks leads to a distinctive hemolytic, physiological and redox profile, thus, making b-thal-het a unique blood donor group. methods: blood samples from healthy non-smoker donors ( b-thal-het carriers and controls) were analyzed before and after preparation and storage of leukoreduced packed rbc units in cpd/sagm at various time intervals. susceptibility in hemolysis (in the presence/absence of oxidative, mechanic and osmotic stimuli), redox status (lipid peroxidation, reactive oxygen species (ros) accumulation, antioxidant capacity), intracellular ca + and proteasomal activities were determined. for statistical analysis, significance was accepted at p < . . samples from the red cell units were collected aseptically, processed (dual centrifugation at , g for min) and stored at À °c. processed samples were thawed, and then analysed using the nanosight ns nanoparticle tracking analysis system (malvern instruments). samples from all time-points from each unit were analysed on the same day. data were analysed by one-way anova with bonferroni's multiple comparisons test. results: at d , red cell units contained an average of . ae . mvs/ ml. the mean size of these mvs was . ae . nm and the mode size was . ae . nm. the concentration of mvs increased gradually throughout storage (p = . ), reaching a maximum at d of . ae . mvs/ml. both the mean (p < . ) and mode (p < . ) size of the mvs increased during storage; however, this size increase primarily occurred in the first week of storage (d vs. d : p < . for both mean and mode). by d , mean and mode size of mvs was . ae . nm and . ae . nm summary/conclusions: nanoparticle tracking analysis demonstrated the presence of mvs smaller than nm in red cell units. both the concentration and size of mvs present in red cell units increased during the days of routine storage. the concentration of these mvs was approximately -fold higher than we had previously detected using flow cytometry (aung, pathology, ) indicating the advantages of more sensitive techniques in characterisation of mvs. background: the lack of availability of sterile saline in a format suitable for use in blood centers for manual washing has led to an urgent need for blood services to consider alternative methods. for operational flexibility it would be desirable to be able to produce a washed rbc unit that had a shelf life longer than h. aims: the aim of this study was to validate the manual method for washing rbcs using sagm solution both as wash and storage solution and to ascertain whether an extended storage period for washed rbcs may be feasible. methods: six day old leukocyte depleted red blood cells (ld-rbc) and six day old ld-rbcs were manually washed and stored in sagm, and half of the units were pre-stored irradiated ( gy). a volume of ml wash solution (sagm) was added to the ld-rbss by sterile connection. after mixing the units were centrifuged for . min at g at °c (hettich roto silenta rs) before removing the supernatant using compomat g extractor. wash procedure was repeated twice using ml sagm solution, and after removal of the last supernatant, ml of sagm solution was added. all units were immediately measured for volume, haematocrit, albumin, iga, potassium, haemolysis, haemoglobin, ph, glucose and lactate and tested again after h, days and days storage at ae °c. results: all washed ld-rbcs met european specification for haematocrit ( . - . ) and all but one for hb content (≥ g/unit). hemolysis increased during storage. the rate of hemolysis in irradiated ld-rbcs was greater over time than in nonirradiated units. all units, both irradiated and nonirradiated, met european specification for hemolysis (less than . %) days after washing. after wash, potassium levels were low and then increased during storage; increase was greater in irradiated than nonirradiated units. potassium concentration days after washing and irradiation did not exceed those levels found at the end of shelf life (day ) of standard ld-rbcs. ph decreased during storage due to the metabolic activity of red blood cells converting glucose to lactate. the ph level of the supernatant depends on the age of the unit and not on the irradiation. the glucose concentration of the supernatant after washing is high due to sagm solution. the concentration of glucose decreased and lactate increased due to the metabolic activity of red blood cells. there is currently no specification in europe or finland for iga in washed rbcs. aabb and american red cross rare donor program stipulate that level of iga should be less than . mg/dl ( . mg/l). our iga method s lower limit for detection is . mg/l and all results were below this level. total albumin were well below finnish specification (< mg/unit). background: room temperature has been the standard storage condition for platelets since the s, when it was shown that this improved in vivo survival compared to when stored at °c. however, storage at room temperature has several disadvantages, including risk for bacterial contamination and short outdating. recently, the interest in cold-stored platelets increased, especially for patients with a hemostatic need. using extensive analysis techniques, we evaluated the in vitro quality of cold stored platelets in additive solution. aims: investigation of the in vitro quality of platelets stored at - °c in pas-e. methods: three experiments were performed, in which two platelet concentrates, prepared from buffy coats and ml of pas-e (pcs) were pooled and split in equal pcs. pcs were stored for days at - °c, one of each pair with agitation on a flatbed shaker and the other without agitation. various parameters were analyzed to study the in vitro quality during storage and compared to routine room temperature storage. results: during cold storage, the swirling phenomenon disappeared within one day. due to the lower temperature, metabolism of the platelets was lower as compared to room temperature storage. the metabolic conditions were acceptable with ph d -d : . - . with platelet count /u and glucose still at mm at least until days of storage. platelet activation maintained acceptable levels with cd p expression < %, while ps exposure increased rapidly; > % after days of storage. aggregation tests showed functional platelets until days of storage. agitation during storage had no effect on any of the tested parameters. summary/conclusions: during storage of platelets at - °c, the hematological parameters and ph met routine requirements, while swirling phenomenon disappeared already at the first day. the functionality of the platelets did not decrease during cold storage, indicating that the swirling phenomenon is not a good surrogate marker under these conditions. the strong increase of ps exposure might be involved in the observed short survival of cold-stored platelets. platelet concentrates stored at - °c are potentially suitable as a hemostatic agent for patients with a bleeding in need of platelets, but more studies are needed. aims: the goal of the study is the reinforcement of platelet reserves for case of emergency events and increasing their availability for treatment, preferentially in patients with massive bleeding. methods: we performed a comparative study with cpp and fp in vitro. buffy coatderived pooled leukoreduced platelets rhd negative were frozen in - % dmso and stored at À °c for months. cpp were thawed at °c, then reconstituted in platelet additive solution ssp+ and compared to fp. we measured these parameters: platelet content, platelet concentration, platelet loss during preparation process, coagulation properties, volume, ph, dmso concentration, titres of anti-a and anti-b antibodies. results: the average platelet loss after the process of freezing and reconstitution was %. the amount of platelets and platelet concentration in unit was lower in cpp compared to fp, but high enough (amount /unit, concentration . /unit). both types of plts (either pcc or fp) maintained an acceptable ph during storage. swirl was on value in fp and on value in cpp. the average plasma content in fp was % compare to . % in cpp after reconstitution. measured titres of igm anti-a and anti-b antibodies were very low ( - : ). cpp had faster clot initiation (rotem clotting time (ct) in cpp . s, fp . s). cpp contributes to a sufficient clot (rotem maximum clot firmness (mcf) in cpp . mm, fp . mm). summary/conclusions: our results shows, that cpp have higher procoagulation activity and simultaneously lower clot firmness. thawing and reconstitution of platelets are easy and fast processes if platelet additive solution is used. this method helps to increase the availability of platelets in emergency medicine. low plasma content in cpp enables their use as washed platelet product in specific groups of patients. methods: after donation, the whole blood was stored in room temperature overnight before separating next morning by reveos â system. seven abo compatible ipus, each with a target volume of ml, were selected and then they were connected to the pooling set provided by terumo bct. prior to the pooling of ipus, ml of additive solution (t-pas+ provided by terumo bct) was added and distributed evenly between the ipu bags. the pooling set was then kept h on bench in room temperature followed by h on agitator at ae °c. after filtration, the pool might be manually adjusted if its volume exceeded the maximum of ml to meet the requirements by the intercept tm blood system. the final products were two pathogen-reduced platelet units with a shelf life of days. results: during validation of the method, pathogen-reduced platelet units were controlled, in addition to the platelet count, for ph, glucose, po , pco and lactate on day , and of storage. the platelet count was . ae per unit on day . the ph value was . on day , . on day , and . on day . the glucose concentration decreased from . to . and . mmol/l on day , and , respectively. the mean po level was . , . and . kpa while the mean pco was . , . and . kpa and the lactate concentration was . , . and . mmol/l on day , and , respectively. since routine implementation of the method in april , regular quality controls showed an average of platelet count of . ae (n = ) with a volume of ae ml per unit. summary/conclusions: the validation of the method and the following two years of experience in routine shows that the pooling of ipus processed in reveos â system meet the requirements needed for intercept tm ds processing set for pathogen reduction of platelets. the results from the quality controls of the final platelet units were in accordance with the local and eu guidelines. methods: data was analyzed from published and unpublished clinical studies that performed both primary and secondary testing of platelets using the bta system. the studies included apheresis and whole blood derived buffy coat platelets and tested - ml sample volume per culture bottle. the studies classified results based on aabb bulletin - definitions with some modifications. the following assumptions were made including: • data was summarized as total number of positive tests, observed by the total number of tests performed on each day post collection; • it was assumed that one test was performed per platelet unit; • all units eligible for secondary testing were negative by the primary test the data needed to demonstrate a benefit for the use of the bta d systems for detecting contamination that was not revealed by previous bacterial testing as well as clinical specificity. results: a total of , platelet units from the studies where secondary testing of platelets was performed were analyzed. platelets were tested on day , , or ≥ , and represented . %, %, and % of the units tested, respectively. true positives were detected in platelet units representing . % of the total platelets tested. the majority were reported from platelets tested on day ≥ with a total of . data showed the bta d system used for secondary testing detects the most prevalent contaminates reported, staphylococcus spp., in ≤ h with the majority detected in ≤ h after incubation, allowing for interdiction of the units prior to transfusion. instrument specificity was reported in of the studies for platelets tested at days and ≥ days with a total false positive rate of . % (range of - . %). instrument sensitivity when used for secondary testing could not be determined since subculture of negative bottles is not performed during routine use. during previous validation testing of lrap and lrwbpc, , culture bottles were confirmed true negatives by subculture. summary/conclusions: data from the studies that tested platelets at to days post collection provided evidence that the bta d with bpa & bpn detects contaminants missed in previously tested platelet units. the data supports that the bact/alert d system is an effective safety measure for secondary testing of platelet products to extend platelet dating beyond day and up to day when testing is performed using the test parameters described in the bpa and bpn bottle ifus and according to the fda draft guidance. background: magnetic nanoparticles have recently shown great potential in nonradioactive labeling of platelets. platelet labeling efficiency is enhanced when particles are conjugated with proteins like human serum albumin (hsa). however, the optimal hsa density coated on particles and the uptake mechanism of single particles in platelets remain unclear. aims: we characterize the interaction between single particles and platelets and determine the optimal hsa amount required to coat particles. methods: ferucarbotran iron oxide nanoparticles were coated with hsa in different amounts ( . - mg/ml) and we confirmed successful hsa coating by addition of a crosslinking hsa antibody (dynamic light scattering). we labeled platelets from pooled platelet concentrates with mm ferucarbotran coated nanoparticles and analyzed labeled platelets for iron content (atomic absorption spectroscopy) and particle localization (transmission electron microscopy). single-molecule force spectroscopy was used to determine binding forces of nanoparticles to platelet compartments. we applied hsa-particles via linkers of different length (i.e. short~ nm, medium nm and long~ nm) on the cantilever tip and let them interact with a platelet provided on a collagen surface. after interaction we determined the rupture force required for platelet retrieval. results: the iron content per platelet reached a maximum at . - . mg/ml hsa coated particles with . ae . and . ae . pg/platelet, respectively. however, the . mg/ml hsa coating resulted in~ -fold higher binding affinity to platelets than particles coated with . mg/ml hsa. depending on peg length between tip and particle, particles interacted differently with platelets as shown by one, two or three force distributions of , , and pn, which correspond up to three different binding pathways, respectively. the results indicate that a particle can interact with three targets including platelet membrane, open canalicular system, and platelet granules. summary/conclusions: our results reveal mechanism of platelet-particle interaction on a single particle level and provide an optimal hsa concentration coated on particles to gain maximal platelet labeling efficiency. labelling of platelets by magnetic nanoparticles may substitute radioactive labeling. results: the activation/lesions on total platelets and small and medium-sized platelets platelet population was detected on storage day , by the increased expression of cd . the percentage of cd -positive cells among the population of large platelets did not change during storage. on the day , increased expression of cd b and cd p was detected, but only on large platelets. small and medium-sized platelets had increased cd p expression only on day . the expression of cd a on total platelets increased significantly on day , and stayed unchanged until day . the same pattern of cd a expression was detected for small and medium-sized platelets, whereas on large platelets the expression continued to increase until the end of storage. a decreased percentage of cd -positive cells was detected among the total platelets and populations of medium-sized and large platelets. the storage induced externalization of phosphatidylserine on total platelets or on any of the platelet populations was not detected. the levels of tgf-b and p-selectin in the pc-bc supernatants were unchanged during the -day storage period. increased annexin and pf concentrations were detected on day . the concentration of b-tg increased on day of storage, and continued to rise until the end of storage. summary/conclusions: the evaluation of expression of activation markers on different platelet populations could be used as an additional analysis in quality control of platelet concentrates, and in the assessment of novel approaches to platelet concentrate manipulation i.e. for testing new additive solutions, cryoconservation protocols, and cryoprotectants. background: the primary goal of autologous blood transfusion is to reduce the risks related to allogeneic blood transfusion, including transfusion-associated graft-versus-host disease (ta-gvhd). although downward trends in rates of autologous blood transfusion have been reported in europe and the americas, it still plays a role in eliminating risks related to allogeneic blood transfusion in japan, especially ta-gvhd. since february , the transfusion service in our hospital has managed autologous blood conservation techniques and helped to prevent mistransfusion by employing a bar code-based electronic identification system. aims: the objective of this study was to determine the use of types of autologous blood components in a single institution over an approximately -year period. methods: between february and december , we retrospectively analyzed autologous blood transfusion, including perioperative autologous cell salvage (pacs), pre-operative autologous blood donation (pad), and acute normovolemic hemodilution (anh). we investigated the use of autologous blood components and the rate of complying with electronic pre-transfusion check at the bedside in the operating rooms. we also determined the adverse reactions to autologous blood transfusion, which were categorized according to the definitions proposed by the international society of blood transfusion (isbt) working party on haemovigilance. results: a total of , patients ( % of whom received operations) received blood transfusion, of which , ( %) received autologous blood transfusion alone, , ( %) both autologous and allogeneic blood transfusions, and , ( %) allogeneic blood transfusion alone. the rate of autologous blood transfusion among patients who received blood transfusion was %. pacs units were transfused to , patients ( %), pad units to , patients ( %), and anh units to patients ( %), and multiple blood conservation techniques were used for one patient. the overall compliance rate with electronic pre-transfusion check at the bedside in autologous blood components was . %. adverse reactions were observed only with pad transfusion and not pacs nor anh. the number and rate of adverse reactions to pad transfusion were and . %, respectively, of which the most common was febrile non-hemolytic transfusion reaction at ( %), followed by allergic reactions at ( %), and hypotensive transfusion reaction at ( %). the severity of adverse reactions to pad transfusion was grade (non-severe) in all cases, and no serious adverse reactions were observed. among pad units, the rate of adverse reactions to whole blood pad units was . %, that to frozen pad units was . %, and that to autologous ffp units was . %. summary/conclusions: our observations indicate that the rate of autologous blood transfusion among patients who received blood transfusion was %, when all types of autologous blood conservation techniques were included. to accurately determine the rate of autologous blood transfusion in a hospital, it may be better for the transfusion service to manage all types of autologous blood conservation techniques. they are now clinically available as a blood product. the residual plasma level of this product, which is prepared using the automated cell processor acp (haemonetics corp.), is approximately %. recently, a retrospective multicenter study was reported that this product was effective and safety for prevention of recurrent or severe transfusion reactions. plt products are generally stored with continuous agitation to maintain their quality. the interrupted agitation of plt suspended in additive solution (plasma carryover: - %) for up to h was previously found to have only a slight impact on in vitro plt properties. however, in some small hospitals with no agitator, if the initiation of transfusion is delayed by an emergent change in a patient's condition, the interruption of agitation may be prolonged. aims: the aim of this study was to evaluate the effects the interruption of agitation for h (shelf life of wpc in japan) on the in vitro qualities of plt. methods: leukoreduced apheresis platelet concentrates in % plasma were washed on day one after blood collection using the automated closed-system cell processor acp (n = ). wpc, which were rested h after preparing, were divided equally into control and test units using polyolefin containers on day one. control units were agitated from days one to seven. test units were stored without agitation from days one to three, and agitation was subsequently performed until day seven. both units were stored at - °c. in vitro plt quality was examined on days one, three, four and seven. results: the plt concentration of prepared wpc was . ae . ( /l) and the volumes of the control and test units after the division were ae and ae (ml). the ph values of the test units on day three were lower than those of the control units; however, the ph of both units were maintained at higher than . during the seven-day storage period. swirling was well maintained and no clumping was visible in both units during storage period. no significant differences were observed in plts concentrates, mpv, hsr, aggregation response. the pco , po , bicarbonate, glucose and lactate mean values of test units were slightly lower or higher than those of the control units on days three or four. the levels of cd p expression were significantly higher in the test units than in the control units on days three ( . % ae . vs . ae . , p < . ); however, this difference decreased in a time-dependent manner after agitation resumed. the levels of cd b expression of test units were relatively lower than those of the control units until day seven, but no significant difference between the two units. background: monitoring residual white blood cells (rwbcs) is a requirement for quality monitoring (qm) the production of leucocyte depleted blood components. although flow cytometry is widely used for monitoring rwbc, there are no widely accepted methods to accurately and consistently measure rrbcs in blood components. sysmex have developed a novel algorithm, termed the blood bank (bb) mode for their xn-series of haematology analysers which is specifically designed to quantitate the levels of rwbcs and rrbcs in blood components. aims: we have previously assessed the linearity, accuracy and reproducibility of the bb mode on spiked samples in an r+d lab. we sought to further assess the performance of the bb software in a routine, high throughput blood component manufacturing department. methods: units of plasma, platelets (pcs) and red cell concentrates (rccs) were produced according to standard uk specifications within nhs blood and transplant (nhsbt). qm of residual cells was tested using the bb mode whilst rwbc was additionally analysed by flow cytometry using bd leucocount kit. results: during a -month field trial over , data points were collected representing all types of manufactured component. for some pcs, bb mode results from some sample tubes that did not contain edta gave very high rwbc values, indicating a potential large number of ld failures. the results were significantly different from those obtained from pcs using edta samples (p < . ) which did not show the same high values. for rccs or plasma, the range of results from plain and edta tubes were not significantly different (p ≥ . ). the analyses of ld platelet and plasma concentrates by either bb mode or flow cytometry both show more than > % of ld components have less than rwbc/unit. for ld failures (n = ) there was a good correlation (r = . ) between flow cytometry and bb mode measurements. spiking studies suggested that the limits of detection and quantitation of rrbc were around and rrbc/ll respectively. residual red cell counts from manufactured components showed a wide variation in their numbers between units. as expected platelet production methods also showed a significant difference (p < . ) in rrbc contamination, with lower levels in apheresis platelets (median = rbc/ll, n = ) compared to those produced from buffy coats (median = rbc/ll, n = ) in our hands, although the time taken to analyse samples is similar for flow cytometry and bb mode, considerable time can be saved on manual handling and the processing of samples for flow cytometry (approximately - h for - samples). summary/conclusions: we have been able to embed the sysmex bb mode into a routine production environment and confirm that its performance in spiked samples is mirrored in routine use. for platelets, sample collection in edta is essential. the bb mode offers an opportunity to reduce operator time compared to flow cytometry whilst gaining additional information on rrbc. abstract withdrawn. results: in our experiment, the typical size of a spectrin matrix section (l) was to nm (without oxidation). the heights (h) of dips were to nm. due to oxidation, the junctional complexes between spectrin and membrane proteins can rupture. only % to % of the spectrin surface has the same structure as in the control group. the values of l and h vary significantly depending on the intensity and time of exposure. we observed significant changes in the spectrin matrix after exposure to uv radiation in a model experiment. the local topological defects in the membrane arise from the action of oxidizing agents on the red blood cells. the mechanism of their appearance is connected mainly with the distortion of the spectrin matrix. as a result of oxidation processes, the spectrin molecules can be damaged. there is a transformation of tetramers to dimers. additionally, it can be easily seen with the afm, that spectrin network structure was essentially destroyed. most parts of the spectrin matrix have damaged structures with mesh breaks and dips after uv irradiation. also the results of network distortions in response to temperature changes were obtained. there are presented preliminary results of spectrin matrix change during long-term storage of prbc. summary/conclusions: atomic force microscopy in direct biophysics experiment allows to observe and to quantitatively measure the disturbances in the spectrin matrix nanostructure in response to oxidation processes in rbcs. these studies are important for the fundamental research of interactions of rbcs on the molecular level during redox processes and the consequences to their structure and function on the cellular level. this is important for the advancement of transfusion medicine, intensive care medicine, and molecular and radiation biology. methods: blood samples were taken from donors during a prophylactic examination and collected with edta-filled microvettes (sarstedt ag and co., germany). all experiments were carried out in accordance with the institute guidelines and regulations. the polylysine-coated glass was used to perform the sedimentation method for formation of native rbc smears. it is important that any fixatives weren't used. the stiffness of rbc membranes was studied in native rbcs (control) and native cells after the application of modifiers: glutaraldehyde, hemin, zn + (heavy metal ions). local stiffness was studied by atomic force spectroscopy (afs) (ntegra prima, (nt-mdt, russian federation). results: experimental kinetic curves i(z) were measured. nonlinear fitting method was used to determine the young's modulus. the experimental dependences of membrane bending were approximated by the hertz model to a depth up to nm. the young's modulus e = ae kpa for control rbc. it was shown that some natural oxidants (hemin), membrane fixatives (glutaraldehyde) modifiers, heavy metal ions (zn + ) significantly increased the absolute value of the young's modulus of rbc membranes up - times. the biophysical parameter hertz depth (h hz ) was determined for each curve. under the influence of modifiers the hertz depth h hz was changed from nm to nm. there are presented preliminary results during long-term storage of blood. summary/conclusions: the blood rheology is determined by rbc deformability, associated with membrane stiffness. the young's modulus can be used as a quantitative criterion to estimate the membrane state of a native cell. the results of the work can be used in clinical practice, in assessment of the quality of donor blood during storage before transfusion, in biophysical studies of rbc state. abstract withdrawn. immunohemotherapy, centro hospitalar universit ario são joão, epe, porto, portugal background: transfusion of blood and blood components is an essential resource in modern medicine. a proper use of human blood, being an irreplaceable resource, is necessary in order to achieve minimal wastage. blood wastage may occur for a number of reasons, like expiry date, haemolysis, seroreactivity or low volume. monitoring wastage of blood product during collection, testing and processing of blood is used as a quality indicator. aims: to determine the annual rate of discarded blood components due to expiry date in a portuguese university hospital blood bank (bb) from january to december , in order to implement appropriate measures to minimize the number of discarded blood to a reasonable rate. methods: we retrospectively analysed the rates of blood components discarded after meeting their expiry date of a portuguese university hospital blood bank from january st to december st . results: a total of , whole blood units and , apheresis platelets were collected during the study period. of the , blood components (packed red cells, whole blood pooled platelets and apheresis platelets) prepared during the study period, a total of , ( . %) blood components were discarded, of those . % due to expiry date. the rate of discarded packed red cells, according to this component production, decreased considerably over the years, in was . %, in was . % and . % in . similar tendency was shown in the pooled platelets for consecutive years with . % ( ) and . % ( ), but with an increase in ( . %). the rate of apheresis platelets had a more variable behaviour from to with rates of . %, . %, and . % respectively. summary/conclusions: blood transfusion is an essential part of patient care. for this reason, the implementation of a quality system and continuous evaluation of all activities of the bb can help to achieve maximum quantity and quality of safe blood. we identified that date expiry was the main reason of discarded blood components, although there was a significant decrease in the rate of discarded packed red cells over these three years. properly implemented blood transfusion policies, donor screening and training staff as well as implementation of automation also helps to improve the process, reducing the discarding rates of blood and blood component. background: storage performance of platelets (plt) is associated with age of the donor. the risk for plt with poor storage performance, characterized by high lactate production and rapid acidification of a plt concentrate (pc), shows a positive correlation with age. we wished to explore whether high lactate production was associated with donor health issues. aims: to investigate high lactate production by stored platelets in relationship to donor health. methods: single-donor pc were collected by apheresis or prepared from buffy coat and donors were evaluated who could be marked as 'rapid acidifiers'. in total, apheresis pcs and pcs from whole blood were included in four studies. information about donor health was obtained either from the blood bank information system or using questionnaires. in some donors, the lipid profile was measured from plasma, and the diabetes marker hba c from red cells. triglyceride levels > . mmol/l and hba c levels > mmol/mol were defined as high. results: twenty two percent ( / ) of the donors were marked as 'rapid acidifiers' and % ( / ) of these donors had health issues. 'rapid acidifiers' were of age , - (median, range) years. three groups of donors can be distinguished: a) donors affected by metabolic syndrome, prediabetes and type diabetes, indicated by high cholesterol and/or triglycerides, high hba c and/or the use of medication to treat diabetes. b) donors affected by vascular diseases who reported or used medication to treat high blood pressure. c) "other" donors who used other medication to treat various other conditions. the remaining 'rapid acidifiers' ( %) did not have high triglyceride or hba c levels and did not report health issues. summary/conclusions: pcs with rapid acidification by high lactate production are mainly collected from older donors with health issues. we postulate that high lactate production by stored plts is associated with health issues, and we will combine detailed donor information (health and behavior) with in vitro quality for a significant number of donations. background: the development of applied biotechnologies requires a search and creation of new methods of cells' functional completeness analysis. the instrumental assessment of platelets quality for the selection of the most effective donors, quality assessment of platelet concentrates for short and long-term storage and for the selection of platelets for cryopreservation is in demand in blood service. assessment of platelets morphofunctional status is possible using morphological studies of various platelet granules fractions (makarov, med. alfavit, ). among the biologically complete platelets there is a special population of cells, the so-called granule-rich platelets (grp). these cells contain the largest number of cytoplasmic granules (more than visually distinct granules). it is established that grp have increased viability and functional activity. earlier we found a correlation between the grp level in blood plasma and shift of the redox potential value in blood plasma after cryodestruction of platelets (tsivadze et al., doklady physical chemistry, ). it was suggested that the shift of the redox potential may be partly due to the release of the low molecular weight antioxidants contained in functionally complete platelets outside the cell. in turn, the concentration of low molecular weight antioxidants can be estimated using the cyclic voltammetry. aims: the aim of the study was to estimate of cyclic voltammetry method possibilities for quality assessment of platelets. methods: the functionality of platelets was examined in platelet concentrate (pc) obtained by apheresis ( . ae . /ll). voltammetric analysis in pc before and after the platelets cryodestruction was carried out on platinum electrode in the potential range from À mv to + mv using a potentiostat ipc pro l and saturated ag/agcl electrode as reference. for the morphofunctional analysis platelets were vitally stained with fluorochrome stains trypaflavin and acridine orange. microscopic examination of platelets was carried out using confocal microscope nikon eclipse i. the following parameters were evaluated: concentration and percentage of platelets with granules and concentration and percentage of grp. results: voltammetric studies in pc show that there are two oxidation peaks of low molecular weight antioxidants on voltammogram at potentials + mv and + mv. analysis of pc before and after the cells cryodestruction showed that changes in the height of oxidation peaks occur, indicating an increase of antioxidant content in blood plasma. at the same time a correlation between the changes in the height of oxidation peaks and the grp content in the sample was found. in samples with reduced initial grp content (less than %) after the cells cryodestruction significant changes in the height of oxidation peaks were not observed, regardless of the total number of cells in the pc. summary/conclusions: in conclusion, voltammetric analysis allows to indirectly estimate the population of functionally active platelets that in combination with other methods of analysis can serve to assess the quality of platelet products. background: determination of hemoglobin derivatives in blood is one of the most important studies in clinical laboratory diagnostics, especially during the storage of donor blood and its transfusion. concentration of hemoglobin derivatives can be changed during redox process. aims: to show the possibility of using non-linear fitting method to calculate concentrations of hemoglobin derivatives during reduction-oxidation processes. methods: for this we performed model biophysical experiment, in vitro. blood samples were collected into edta microvettes from healthy donors (sarstedt ag and co., germany) during prophylactic examinations. all the donors gave their consent to participate in the study. a suspension of erythrocytes was prepared in pbs buffer with ph . . we used ultraviolet (uv) irradiation of blood or nano as oxidizing agent. the drug cytoflavin (stpf "polisan", russian federation) was used as an antioxidant. in our study we used digital spectrophotometer (unico , usa) to measure the absorption and scattering of light ( . nm step). the method of nonlinear fitting was used to find the concentrations of hemoglobin derivatives. the empirical spectrum d l (k) exp was approximated by the theoretical curve d l (k l ) theor , which fits the experimental curve in the best way. under approximation the light absorption by different hemoglobin derivatives was considered in model. simultaneously effects of rayleigh light scattering on structures with size d<< k (coefficient s) and light scattering on particles with size d≥ k (coefficient k) were taken into account: d l (k l ) theor = e hbo ,l c hbo l+ e hb,l c hb l+ e methb,l c methb l+ e hbno,l c hbno l+ e methbno -,l c methbno -l+ e methbno,l c methbno l+k+s/k l ( ), where e h,l is the molar absorption coefficient for each hb h derivative at given wavelengths k l , c h is the concentration of the derivatives hb h , l is the thickness of the solution layer, d l (k l ) is the optical density of the substance, k and s are the parameters of the model. results: we determined the concentrations of hemoglobin derivatives without any additional chemicals in blood. there were measured experimental spectra for different agents action on blood. it was shown that concentration of methb increased after uv irradiation and nano action (up to %). there were calculated c h for each hb h derivative. it was established that theoretical curves coincide with experimental data with good accuracy (r = . ). incubation of rbcs with cytoflavin leads to reduction of methb to hbo . summary/conclusions: the determination of hemoglobin derivative concentrations by the method of nonlinear fitting (without adding special chemical agents to blood) can be used for measurement of carboxyhemoglobin in blood during toxic state of organism. also it is important for assessment of rbcs quality before blood transfusion. background: the use of in line leukoreduction filters have been highly expanded in iranian blood transfusion centers within the last decade in order to provide sufficient leukoreduced blood fractions from healthy safe frequent blood donations to be supplied to the leukocyte sensitive patients. leukoflex lcr , the dominant brand of such filters procured by iranian blood transfusion organization, is the most updated generation of the filters used around the world. aims: in this study, it is tried to recover the trapped leukocytes from this novel filter by different buffering systems and having optimized the elution mode, the cell differential of the viable recovered white blood cells were determined by flow cytometry. methods: having passed the routine virological tests, eight leukoflex lcr leukoreduction filters freshly used in tehran blood transfusion center were daily collected and each were back flushed by a self-designed mechanical system (a peristaltic pump, a triple junction with regulator part and an air pump) using various conditions and additives for pbs buffer at different phs in order to find the highest recovery yield for leukocytes. the optimized elute was characterized by flow cytometry for subcellular profile to be determined. results: it was illustrated that a system consisting of pbs (without cacl and mgcl ) in ph . containing mm edta and %(w/w) dextran without additive amounts of triton x was the most optimized buffering system for lcr filter back flushing. total cell content was also determined as . * granulocytes, . * lymphocytes and . * monocytes using auto hemoanalysis and flow cytometric methods. summary/conclusions: in addition to partly compensating of the overhead expenses inflicted by application of leukoreduction filters on healthcare system, the results will assist blood organization system to be more classified in rational profile design, future cell therapy strategies and exceptional blood management. also, the recovered cells could be of significance in stem cell science, cellular interaction studies as well as novel molecular developments in drug discovery. vox sanguinis ( ) results: three lines of strategy are in place to pursue self-sufficiency of the largest number of pdmps. first strategy line: maximizing the yield of driving proteins, represented by immunoglobulins (ig) and albumin; this was assured by csl behring with a yield of . g ig ( % intravenous -privigenand % subcutaneous -hizentra) and g albumin (alburex) per kg plasma fractionated, corresponding to . g ig and . . g albumin; based on present demand, this represents % and % self-sufficiency, respectively, for naip regions. second strategy line: ensuring other products from plasma fractionation; the fractionator granted . g fibrinogen (riastap) and . . iu vwf/fviii (haemate p) per year, which corresponds to the present demand of naip regions for both products, but it is under the full potential of plasma, thus providing a high margin of safety in case of increased demand (now the case of fibrinogen). third strategy line: exchanging cryoprecipitate, fibrinogen and vwf with italian regions whose plasma is fractionated by other companies to obtain prothrombin complex concentrates (pcc -kedcom) and antithrombin (atked) as to satisfy naip regions demand; this strategy allowed a supply of . . iu at and . . iu pcc, capable of ensuring self-sufficiency for naip regions until . summary/conclusions: in italy, differentiation of plasma contract manufacturing among companies with different portfolios allowed naip regions to obtain a significant contribution to self-sufficiency from vnrd plasma for a variety of pdmps by different and complementary strategies consisting in maximizing the yield and the portfolio of proteins from the fractionator and exchanging products among regions for other pdmps at high demand but not included in the portfolio of a single fractionator. plasma check system: a valuable tool for plasma freezing validation and monitoring. background: the validation of plasma freezing processes may result problematic in the monitoring/control of critical process parameters (cpp). in in italy , litres of plasma were produced and frozen. aims: in order to assist plasma freezing validation and cpp monitoring, of the italian bes performing plasma freezing utilize the plasma check system (pcs), a system able to record, store and certify the temperature (t) detected at the core of "surrogate" bags during the entire freezing session, consistently with gmp requirements. pcs is patented and commercialized by expertmed srl, verona, italy (http://www.expertmed.it). methods: pcs consists of parts: a) "surrogate" bags (check-bags) of and ml corresponding to the average standard volumes of the real products, containing a fluid validated to simulate the thermal behaviour of plasma; b) a mobile probe (cryo-med) positionable at the core of the check-bags; c) a dedicated software (memo-track). plasma freezing session data are tracked via barcode/rfid and can be consulted by the pcs that associates blast freezer code, operator code, cryo-med and check-bag. data on plasma freezing are stored in a shared folder and transferred to the be information system. the pcs can also be used to check and monitor the out-of-storage variations of core t of frozen plasma unit, i.e. during labelling and packaging procedures, thus allowing to establish optimal timeframes and operations and suitably validate these procedures. in the period - , at the pievesestina be of emilia romagna region , plasma units were frozen so as to allow complete freezing within to a temperature below À °c, in , freezing sessions, using the pcs both for process validation, change control and for the systematic monitoring of core t at each freezing session. furthermore, at the bologna be tests on the out-of-storage conditions of plasma units were carried out to revalidate the procedures of labelling and packaging. results: out of , freezing sessions carried out at the pievesestina be, ( . %) were detected to fail to reach À °c at the core of the check-bags within . of the latter, in most cases ( %) a technical error in the activation of the cryo-med was identified. in addition, the pcs was systematically utilized for periodical revalidation of the freezing procedures. the tests performed at the bologna be to validate the out-of-storage procedures of frozen plasma labelling and packaging allowed to modify the operating procedures in place so as to establish optimal timeframes and operations. this prompted corrective actions regarding: i) number of units to be taken out of storage sites at each labelling session (< units), ii) labelling time (< ), iii) optimal storage t (À °c vs. À °c), iv) optimal time between two openings of storage sites (> ). summary/conclusions: the pcs is a valuable system for plasma freezing validation and monitoring, as well as to perform monitoring and control of the whole pathway of frozen plasma in the be. it is a technologically advanced, easy-to-use and costeffective tool that can efficiently replace other traditional methods commonly used for the above-mentioned purposes. assessment of blood group matching quality using six sigma metrics background: six-sigma metrics provides a general methodology to evaluate a process performance on a sigma scale. implementation of six-sigma for quality assurance can benefit the health care sectors. one of the most important health care sectors is blood transfusion service. for that reason, maintaining a high quality in blood transfusion service is required. pathogen in activated plasma is one of the main products that are provided by the blood transfusion service. the process of producing pathogen inactivated plasma involves blood group matching step. the quality of this blood group matching is extremely significant for the delivery of plasma that satisfies the recipient need. aims: the aim of this study is to assess the quality of blood group matching of pooled plasma units using six sigma metrics, and to clarify the potential implementation of six sigma metrics as a quality management tool. methods: this retrospective study was conducted in the component preparation lab of kuwait central blood bank. the twelve months (january -december ) data of pooled fresh frozen plasma units were recruited and examined. the data was separated to data without double check ( months) and data with double check ( months). data statistics and analysis were conducted by the use of six sigma metrics. results: in a sample size of from the first six months a mismatch was found which equals dpmo and . sigma metric. and in a sample size of from the second six months a mismatch was found which equals dpmo and . sigma metric. out of the whole pooled units were found to be mismatched. some of which were found to be discarded as abo discrepancy, broken, or expired. other was still available in the system, while the rest of the mismatched units were issued. summary/conclusions: using the six sigma principle the study presents a successful assessment of blood group matching quality. as a . sigma metrics obtained from the first months, were shifted to a sigma metrics of . in the second months, after the addition of a double-checking step to the blood group matching of pooled plasma process. the implementation of these metrics in our laboratory quality management has been shown to be very beneficial. in which six-sigma metrics were able to clarify the reduction in blood group matching errors. although six-sigma benefits in major quality improvements and helps to reach an error free laboratory services, yet it presents a new challenge to laboratory practitioners. currently, the hemophilia a patients treated with factor viii concentrated as the first line of therapy but it is more expensive and the supply is not sufficient so for now they have not used factor viii concentrate as prophylaxis therapy. for some cases, hemophilia patients in indonesia depend on subsidy from the world federation of hemophilia. the first handicapped concentrated case is just for therapy not for prophylaxis. big blood centers in indonesia produce routinely fresh frozen plasma (ffp) and cryoprecipitate-anti hemophilic factor (ahf) as replacement therapy for hemophilia a, but its content and safety of factor viii from ml ffp need to be improved. nowadays, there is an available kit for producing minipool cryoprecipitate (mc) that has better safety and quality but it is available as liquid products, stored in very strict and specific temperature (À °c). prophylaxis therapy for hemophilia patients needs a stable product, easy to use and convenient treatment for patients. aims: to analyze the content and safety of f viii with minipool cryoprecipitate (mc) and lyophilized mc for home therapy. methods: we produced mc; mc as the control, mc were lyophilized with excipient and mc without excipient. we analyzed the number of factor viii, the safety, and stability. we count the erythrocyte, leukocyte and platelet residual in mc using flow cytometry. we also measure the ph, osmolality, solubility to learn its stability after storage at days at room temperature ( - °c) and blood bank refrigerator temperature ( - °c) at central blood transfusion services (cbts). results: we found the content f viii with excipient is higher ( . iu/ml) than without excipient ( . iu/ml) and the storage at blood bank refrigerator ( - °c) is better than at room temperature ( - °c) . in both group, there were no residual cells and bacterial found in mc. no significant difference in the ph, osmolality and solubility in both groups. summary/conclusions: the lyophilized mc with excipient stored at blood bank temperature ( - °c) is better than room temperature. this experiment will be continued to know its stability in extended storage time. background: peptic ulcer disease (pud) is a multifactorial and complex disease, and it affects a wide range of people in the world. however, a perfect therapy for pud has not yet been available at present. therefore, we provided a novel therapeutic approach for pud patients and observed its effect in this study. aims: we provided a novel therapeutic approach for pud patients and observed its effect in this study. methods: in this randomized controlled trial, pud patients residing in chongqing were enrolled from to . they were randomly assigned to two groups: (a) a control group used only rabeprazole, and (b) a platelet-rich plasma (prp) group that received a combined therapy of autologous platelet-rich plasma (aprp) and rabeprazole. the aggregation rate of aprp was measured via aggregation remote analyzer module. the therapeutic effect was assessed via the ulcer size and the symptom score. all data were recorded and analyzed statistically using spss. results: a total of patients were included ( patients as control group) and ( patients as prp group) in the analysis. we found that the aggregation rate of aprp is not affected in ph . after treatment with pepsin. our results showed that there were no significant differences between the prp group and control group before the treatment, and there was also no significant difference in healing time between the two groups in different variables. however, regression analysis revealed that the healing time was . d less in the prp group than in the control group, and the patients with higher symptom scores in the initial examination need more time to heal in treatment. summary/conclusions: this study showed an encouraging preliminary result that aprp has a positive result in the peptic ulcer patients, and it seems to be a better choice for refractory pud patients. despite the further follow-up studies are needed to determine the duration of efficacy of aprp, the approach will be helpful for improving the pud treatment in clinical. background: the croatian institute of transfusion medicine (citm) collects, produces and distributes blood components in an area of . million habitants. annually, it collects about , whole blood and , apheresis donations. platelet concentrates (pcs) are more inclined to bacterial contamination due to storage conditions that favor bacterial replication. the citm decided to evaluate the mirasol pathogen reduction technology (prt) system as it offers the possibility to work with a non-toxic, non-mutagenic compound that upon uv illumination induce nucleic acid damage, reducing the risk of septic transfusion. aims: the study objective was to evaluate quality of pcs treated with the mirasol prt system for platelets and stored in tpas+ for days at °c on a platelet shaker. methods: pcs were produced according to the citm's s.o.p., either through pooling of bc with tpas+, "wbd", or through apheresis collection using two devices: the fresenius amicus, "ad" and haemonetics mcs+ system, "mcd". pcs were stored in % plasma and % pas and mcd were subsequently evaluated also in % of plasma and % pas. identical pcs were produced with a pool-split protocol to be prt-treated or serve as untreated control. pcs were treated with the mirasol system according to manufacturer's instructions. qc parameters, such as yield, ph and swirl were measured at days , and . bacteria sterility test was performed at day for a sample of all treated platelets. protein content of pcs produced routinely at the citm was determined to assess accuracy of plasma carry-over calculations for all processed pcs. results: mirasol-treated wbd (n = ) and ad pcs (n = ) stored in % plasma showed at day an average ph ≥ . ; swirl ≥ . and yield = . . their untreated counterparts showed average values for ph ≥ : , swirl ≥ . and yield . - . . mcd stored in % plasma (n = ) that underwent prt showed at day average values for ph = . , swirl = . and yield = . . control mcd showed average values for ph = . , swirl = . and yield = . . mcd stored in % plasma (n = ) that underwent prt showed average values for ph = . ., swirl = and yield = . . their untreated counterparts had average ph = . , swirl = . and yield = . . total protein content in pcs derived from wbd (n = ), ad (n = ) and mcd (n = ) was g/l, g/l and g/l, respectively. while the coefficient of variation of wbd and ad ranged from % to %, plasma products respectively, the one of mcd reached %. all prt-pcs were negative for bacterial growth at day . summary/conclusions: mirasol treated wbd and ad produced according to citm current s.o.p. were quite similar to untreated controls at expiry, on day and passed the requirements of the eu guidelines ( th edition). quality of mcd units met eu criteria at day ; swirl decreased significantly at day which might be explained by the variability in plasma content of mcs+ -derived platelets, challenging the accurate calculation of illumination index for the mirasol treatment. all mirasol treated pcs showed minimal platelet loss at the end of storage. as the implementation of pr had to be cost-neutral it could only be implemented for~ % of the annual produced buffy coat platelet concentrates (bcp) (~ . bcp/year) and required a change in the bcp production method. the primary aim of the implementation was to offer increased blood safety to our most vulnerable patients. the secondary aim was to ensure that we built-up enough routine experience with pr to enable us to quickly ramp-up the production of pr-bcp to % if there were an outbreak of an emergent pathogen in the madrid region. aims: to verify if we could produce~ % pr-bcp without increasing the overall production cost (opc) for bcp. also evaluate the impact of pr on overall scrap rates of bcp, outdate rates and usage of other safety measures. methods: we compared opc for bcp between the pre-pr period ( ) . this cost was offset by substituting a semi-automated production method for bcp, which was used in to produce . % of bcp-units. a manual double dose buffy coat production method (dd-bcp) in combination with pr enabled us to reduce the bcp-disposables cost by . %. despite the moves from a semi-automated to a manual production method the overall scrap rates during production decreased in by . %. the extension of max. storage time from to days for % of the bcp-units that were pr resulted in decreasing our overall outdating rates by % (versus ). this reduction in outdating rates reduced our opc in by . %. in we gamma-irradiated . % fewer bcp-units, but this had only a minimal impact on the opc. summary/conclusions: results of this study confirmed that we reached our initial objectives of producing~ % pr-bcp without increasing the overall production cost (opc) of bcp. it enabled us to offer increased blood safety to the most vulnerable patients. we built-up enough routine experience with pr so we could quickly rampup the production of pr-bcp to % if there were an outbreak of an emergent pathogen in the madrid region. background: irradiation of red cell units is undertaken to prevent transfusion-associated-graft-versus-host-disease (ta-gvhd) in immuno-compromised patients. while irradiators using radioactive c-ray sources are primarily found in blood establishments, they require regular recalibration and supplementary safety measures. xirradiation has been shown to have similar biological effectiveness to c-irradiation and does not require a radioactive source. there is international interest in moving away from gamma sources to reduce vulnerability to terrorism. although damaging, impacts of irradiation on red cells are well recognised. only a limited number of studies have compared red cell component quality following cand x-irradiation for both standard volume red cell concentrates (rcc) and neonatal red cell splits (rcs). aims: to compare the in vitro quality of rcc and rcs when subjected to cor xirradiation on day of storage then stored for a further days. rcs were also irradiated on day of storage as that is most common practice in nhs blood and transplant (nhsbt). methods: four rcc were pooled and split into arms on day of storage, with units in each arm. all units received an irradiation dose of . - . gy. two arms remained as standard volume rcc and were either cor x-irradiated on day of storage. the other two arms were both split into rcs on day of storage before being irradiated on day (early arm) or day (late arm) of storage. for each replicate in these arms, splits were c-irradiated and splits x-irradiated. all arms were tested a day prior to irradiation and , and days post-irradiation for red cell quality parameters: haemolysis, intracellular atp and , dpg, supernatant potassium, glucose and lactate, ph and red cell microvesicle release. the rcc arms were sampled over storage; while for the rcs arms, split was tested on each testing day post-irradiation. a -way anova was used to detect statistical differences over storage between cand x-irradiation for the same components. results: all components produced were within nhsbt specification for volume, haemoglobin and haematocrit. there were no significant differences in red cell in vitro quality parameters studied over storage between cand x-irradiated units, for standard volume arms or neonatal arms and whether rcs were irradiated early or late in storage. moreover, all arms were within haemolysis specification for the end of storage (> % of units with < . % haemolysis) and % of units had atp levels above the recommended minimum for acceptable post-transfusion survival ( . lmol/ghb). both haemolysis and potassium levels at the end of storage for the standard c-irradiated rcc were comparable to our laboratory's historic data for the same component. summary/conclusions: in summary, the storage quality of rcc and rcs post-xirradiation did not differ from c-irradiation in this study, providing reassurance that either method could be used in routine manufacturing. a pajares herraiz , c coello de portugal , m morales , f solano , c perez parrillas , a rodriguez hidalgo , t diaz rueda and m flores direccion, regional transfusion center toledo-guadalajara transfusion service, toledo hospital complex, toledo transfusion service, general university hospital of guadalajara, guadalajara transfusion service, hospital nuestra señora del prado de talavera de la reina, talavera regional transfusion center, regional transfusion center toledo-guadalajara, toledo, spain background: the regional transfusion center of toledo-guadalajara (rtc) manages the collection, processing and distribution of blood components for the hemotherapy area of castilla la mancha (spain) that serves general hospitals (hospital complex of toledo (hct), university general hospital of guadalajara (ughg) and hospital nuestra señora del prado de talavera (nspt)) and the needs of , inhabitants. by also managing the hct transfusion service, it facilitates the handling of stocks. since , rtc has initiated pathogen inactivation (pi) for a part of its platelet components(pc) with the intercept blood system (cerus) using a photochemical treatment with amotosalen and ultraviolet-a. this system allows the inactivation of a broad panel of pathogens and leukocytes, extending the shelf-life of the cp from to days. this affects the expiry and discards of this blood component, allows a better management of the inventory and has an influence on production costs. aims: the objective was to evaluate the influence of pi in the production of cp at rtc and the expiry in the hemotherapy area during the last years divided into four periods ( results: pc were predominantly obtained from whole blood collections with % of bc platelets/ % of apheresis platelets. % of the available bc were used in production for period a and % for periods b, c and d. after wastes of approximately . %, the distribution of pc was stable for the periods studied. pc were distributed for period a, pc for b, pc for c and pc for d. the % of pi platelets with -day shelf life available in the hospitals was limited to % during period a. it was then increased to . %, . % and % for periods b, c and d respectively. the percentage of wastes was stable at . - . % but the discards due to expiry went down from . % (period a) to stabilize at . % in periods b and c and . % in period d. in the general hospitals the expiry went down from % to . %(hct), . % to . % (ughg) and . % to . %(nspt) respectively. summary/conclusions: greater control of pc stocks through historical analysis and consumption projection, together with it tools and the use of pi pc with -day shelf life allowed reducing discards for expiry from . % to . % in the last period analyzed at rtc and the major hospitals of the hemotherapy area. this has a great value in cost-reduction and improves inventory management and the efficiency of the processes. background: blood centers are faced with many challenges including availability of concentrate platelets as well as ensuring highest quality of the product. overcoming the shortage of platelet apheresis by using pooled platelet derived from whole blood units separated using automated standardized system, which can assist blood banks to meet the increase demand in platelets. the pathogen inactivation (pi) technology can improve the quality of the product by mitigating the risk of transfusion-transmitted diseases (ttd) and residual white cells, resulting in minimizing non -hemolytic transfusion reactions. however, the pathogen inactivation treatment must not impact the platelet quality and functionality significantly, as well as the patient safety. aims: evaluate the quality of pooled platelets derived from whole blood (five interim platelet units), separated using reveos automated blood processing system (terumo bct), pooled in % donor plasma and pathogen inactivated by amotosalen/uva technology. methods: five interim platelet units (ipus) produced with reveos device (terumo bct) from single whole blood donations, were pooled with a platelet pooling set (terumo bct) and leucodepleted with a lrf-xl filter (haemonetics). thirty pools have been included in this study, the units were treated using a large volume cerus intercept processing set for platelets according to the manufacturer's instructions and stored until day . the swirling was determined by visual inspection. the volume and yield content were assessed preinactivation and after treatment by pathogen inactivation with a cell counter (dxh- , beckman coulter), rbc contamination was also measured preinactivation with a cell counter (beckman coulter), bacterial contamination was assessed by automated blood culture with a bact/ alert system (biomerieux). the ph of the platelet units was assessed with a phmeter (jenway), and residual amotosalen levels were assessed by an hplc assay. results: the impact of amotosalen/uva pathogen-inactivated pool platelet products quality were assessed. the pre and post-inactivation of the units showed a swirling score of - . the average volume per unit of the pre-inactivation was ml ( - ml) and post inactivation was ml ( - ml), with average volume loss during inactivation was ml ( - ml), corresponding to % ( - %). the average platelet yield per unit pre-inactivation was . ( . - . ) and post inactivation . ( . - . ) with an average platelet loss of % ( - %) . the average rbc contamination per unit ( . - . rbc/ml). the culture tests were negative, the average ph at day was . ( . - . ), average ph at day / was . ( . - . ). the average residual amotosalen concentration post treatment was . lm ( . - . lm). summary/conclusions: the quality of pathogen-inactivated pool platelets tested, met the criteria set by aabb guidelines. the volume and platelet loss were in acceptable range, in alignment with previously published data. a residual amotosalen concentration below lm is considered safe and acceptable by french and german authorities. the evaluated data support the reasonable assurance of quality and effectiveness of the device when used in accordance with indication for use. background: the implementation of a pathogen inactivation process (pi) allows the redesign of processes to obtaining safe blood components by reducing the need for additional testing for pathogens detection, minimizing the residual risks (such as the infectious window period for those pathogens that are detected as usual), eliminates the need for selective tests (eg cytomegalovirus serology test) and complements gamma irradiation given its ability to inactivate white blood cells. in addition, the routine implementation of pi reduces the incidence of bacterial infection in recipients of blood components and allows blood services to proactively protect the blood supply against future emerging infections. aims: to verify the functional integrity and viability of platelet concentrates after being inactivated of any pathogenic agent, to be used as safe and functional components for transfusions. methods: a total of independent platelet concentrates were studied. platelets are donated through a process called plateletpheresis according to the established norms, after the process, platelet concentrates were submitted to pi on the intercept blood system tm platform with uv-a illuminator; an immediate sampling of each donation of platelet concentrates was carried out taking a sample of ml pre-inactivation and another sample post-inactivation ( h after pi). the platelet viability of each sample was evaluated by demonstrating the cd p expression marker by flow cytometry. once processed, platelet concentrates were released as safe components for donation. compiled the experimental data of the platelet count with platelet activation marker with respect to the total platelet, a comparative, nonparametric test of wilcoxon was carried out between two measurements (pre vs post) and the platelet viability after pi was determined. results: a total of independent platelet concentrates were studied, where the average percentage of pre-inactivated platelets with expression of the cd p marker, was %, while the percentage of functional platelets post inactivation was %, this result only shows that the functionality of the platelets is not being altered after the inactivation process. the wilcoxon test confirms that there is no significant difference between platelet activity pre-and post-inactivation, with a % confidence level. summary/conclusions: the process of photochemical treatment with amotosalen hydrochloride and long-wavelength ultraviolet light (uva) applied to platelet concentrates provides functional products without alterations in platelet function to be transfused. background: treatment of platelet concentrates (pcs) with pathogen reduction technologies is widely implemented in blood establishments to reduce the risk of bacterial contamination and to face the presence of new emerging agents in blood components. aims: the reduction of antioxidant power (aop) could be a quality control test to prove the complete viro-inactivation treatment. this evaluation has the goal to study the feasibility of the method from "abonnenc et al., transfusion, " in another blood service, assessing the aop of platelet units treated by intercept technology. methods: the aop is expressed in edel value, one edel being equivalent to lmol/l ascorbic acid. repeatability, intermediate precision and accuracy were determined. linearity was evaluated using the linear regression and the calculation of pearson's coefficient (r²). limit of quantification (loq) was determined by measuring aop using nacl samples to define the background. roc curves were used to determine a threshold to discriminate pcs before and after treatment. a distinction was realized between men and women and between apheresis (a) pc and buffy coats (bc) pcs. a one-year evaluation was assessed on pcs before and after treatment on the routine production. results: the coefficient of variation for the repeatability was less than %. for the intermediate precision, the coefficient of variation was less than %, but for the pcs after treatment, this result rose up to %. the r² value for the linearity was . %. the detection limit corresponded to a result of edel and the loq (equal to xsd) is edel. concerning roc curves, the men apcs threshold was . edel compared to women apcs with . edel. the threshold for bcpc was edel. all of these results had % of specificity. below this threshold, intercept treatment was considered to be executed. about the one-year experience on routine pcs production, apcs ( women and men) and bcpcs were tested. all of the bcpcs and women apcs were under the threshold after treatment. concerning men apcs, . % of the pcs after treatment were not under the threshold. summary/conclusions: the device validation was satisfied. for the one-year evaluation and concerning men group apcs, the threshold found by abonnenc et al. was edel. our study showed a threshold with % specificity and % sensitivity at . edel which is much lower. specificity was favored compared to sensitivity but the analysis should be revised to adapt the threshold to get higher sensitivity. this can lead to reduce the non-conformity and allows measuring the aop only after treatment. for women, our threshold was found at . edel compared to . edel for abonnenc et al. concerning sex in apcs, results were statistically lower in women group than men group before and after treatment. and for bcpcs, the two populations (before and after treatment) were very distinguishable and our threshold ( edel) was lower than abonnenc threshold which was at . edel. in conclusion, edel threshold enables the segregation and depends on the preparation process adapted in each blood service. aims: this study has the goal of measuring antioxidant power (aop) level in plasma units treated by mb technology. the aim is to use such a test as a quality control assay for documenting the execution of pathogen inactivation treatments during the preparation of plasma units. methods: aop measurements were performed using a potentiostat electrochemical analyzer. a -ll volume of sample is deposited over the electrodes on a single-use microship. the aop is expressed in edel value, one edel being equivalent to lmol/l ascorbic acid and reflects the redox status of the plasma units. different protocols were established to understand the role of mb, the illumination and the filtration on the aop variation measure: ) complete treatment, ) plasmas with mb without illumination, ) plasmas without mb with illumination and ) plasmas without mb without illumination. ten dosages on men donor samples, except for protocol where n = , were realized during the viro-inactivation process, t corresponds to a dosage of plasmas before treatment, t the plasma after the mb dry tablet passage, t is the time after illumination and t corresponds to the final product (after filtration). results: in each protocol with mb, an increase was observed after addition of mb before illumination. after illumination, the edel values decreased for about less than %, which was expected because of the degradation of mb in its photoproducts during the illumination. in the series and , the illumination seemed to have an effect by itself, with or without mb because the aop increased. the final filtration has the goal to eliminate the residual mb and its photoproducts. after this step, the aop values fell down. the series was a confirmation of the efficacy of the filter to remove the mb as shown by the decreased aop in t ( ae edel at t and ae edel at t ). however, in the absence of mb (series and ), the results at t and t were not statistically different. summary/conclusions: the filtration decreases the aop rate, except when there was no mb. the results of non-complete viro-inactivation treatment allow concluding that the measure of aop rate may not indicate that the treatment was completed or not since significant differences before and after treatments were found in the non-complete treatment series. vox sanguinis ( ) background: the intercept blood system (ibs), a photochemical treatment with amotosalen and uva, is used to inactivate pathogens and leukocytes in plasma. the intercept tm plasma processing set (cerus bv, netherlands) was modified to incorporate plastic containers in non-pvc materials sourced from alternate suppliers and connecting parts and accessories in non-dehp pvc formulations, making the system dehp-free. the final storage container was modified with a higher contact surface with plasma to limit the thawing time. proportion of units with a fibrinogen concentration ≥ . g/l was % (> % required). mean recovery fviii fibrinogen after ibs treatment and frozen storage were % and %, respectively. residual platelets were < /l, leucocytes < /l and red blood cells < /l. all units had a protein content > g/l. residual amotosalen was below lm in all post-cad samples. the concentration of tat complexes was slightly reduced after treatment and frozen storage. concentrations of c a and c a were significantly reduced with the cad treatment. the plasma thawing time in a water bath at °c was consistently short ( - min). summary/conclusions: pathogen inactivated plasma units (ffp-a-ibs and ffp-wb-ibs) prepared with dehp free intercept processing sets retained in vitro characteristics which meet the quality standards for therapeutic plasma. the process did not activate coagulation or complement. reducing ffp thawing time from routine - to - min is an important benefit for emergency use. background: plasma coagulation factor concentrations usually differ for individual donors, therefore pooling of whole-blood derived plasma units moderates high or low coagulation factor concentrations and ensures transfusion of more standardized blood components. moreover, pooling contributes to dilution of reactive antibodies and may reduce the risk of non-hemolytic transfusion reactions and trali. additionally pathogen inactivation reduces the risk of transfusion-transmitted infections, and non-hemolytic transfusion reactions as well as gvhd through inactivation of residual lymphocytes. aims: assessment of the impact of plasma pooling and pathogen inactivation on the standardization of blood components and plasma quality. methods: the study included experiments. for each experiment male-donor, abo-compatible whole-blood derived plasma units (≥ ml) were collected from different donors and pooled using the donopack optipool plasma pooling set (cerus europe b.v.). each of the -unit pools were split into equal minipools which were subsequently treated with the in intercept blood system (cerus europe b.v.). then, each minipool was split into (≥ ml) therapeutic units. samples were collected before and after pooling as well as after inactivation to assess the coagulation factor content (fviii, fix, fibrinogen, vwf antigen using elisa) and coagulation time (aptt, pt). the study-analysis included samples from five pools from single plasma units respectively ( background: biotin (bio) is an alternative to radioactive red blood cell (rbc) tracers which allows one to concurrently track in vivo multiple cell populations labeled at different bio densities. in american clinical trials, multi-labeled biorbc have been transfused in man to assess their survival (mock et al, transfusion, ) . in these studies, the different biorbc populations were monitored by ex vivo flow cytometry analysis using streptavidin. so far, the biotinylation reagents biosulfonhs was not complying with good manufacturing practices (gmp). moreover biorbc, with bio ≥ lg/ml, have induced immunization of the recipient, in rare cases (schmidt et al, transfusion, ) . this represents an obstacle regarding the regulatory european authorities. aims: the aim of this study is to describe a procedure of biotinylation of rbc intended for clinical trials while refining the levels of bio ≤ lg/ml. methods: sterile status is met throughout the process. rbc are taken from standard rbc concentrates and treated with biosulfonhs of gmp-grade ( to lg/ml) recently commercialized. washing buffer is of injectable-grade. biotinylation efficacy is controlled by flow cytometry with streptavidin conjugated to different fluorochromes: phycoerythrin (pe) or brilliant violet (bv ). results: labeling with biosulfonhs of gmp-grade or non gmp-grade is comparable and populations of rbc could be easily distinguished between themselves and from unlabeled blood cells. biosulfonhs (lg/ml): (mfi . ), (gmp mfi ; non gmp mfi . ), (gmp mfi ; non gmp mfi ), (gmp mfi ; non gmp mfi ). streptavidin-bv brighter than streptavidin-pe is a promising tool because it amplifies by . the signal of fluorescence and allows a good differentiation of the populations of rbc treated with only , , and lg/ml biosulfonhs. summary/conclusions: this preliminary study explores the feasibility of multilabeled biorbc production for clinical trials. the benefits of this approach are to overcome the need for non-radioactive tracers, to follow simultaneously various populations of rbc and consequently to limit the number of volunteers, and to reduce the risk of immunization using bio ≤ lg/ml. background: rejuvenation is aiming to revert ageing-related disease development. heterochronic parabiosis studies revealed eotaxin in young and old murine blood as a regulator of brain aging and neurogenesis. umbilical cord blood (ucb)-borne factors including tissue inhibitor of metalloproteinases (timp ) and neonatal immune cells also contributed to rejuvenation in animal models. human platelet lysate (hpl) is commonly used by us and others for highly efficient cell propagation in vitro (burnouf et al., biomaterials, ) . published data indicate only limited differences between adult and ucb-derived hpl, partly questioning enigmatic rejuvenation effects. aims: to verify candidate regenerative factors in neonatal blood products we compared protein contents of neonatal and adult plasma and platelets, respectively. methods: heparinized ucb samples (n = ) were centrifuged within h to collect neonatal platelet rich plasma. aliquots from apheresis platelet concentrates (n = ) were used as adult counterpart. platelet concentration was adjusted to - / l. plasma supernatants and platelets were obtained by centrifugation and platelet pellets were re-suspended in saline. after two freeze/thaw cycles at À °c/ °c for platelet lysis (npl; apl) the platelet fragments were removed by centrifugation. the protein content was analyzed with a proteome profiler tm array. nine samples of each group were pooled to avoid individual donor variations. a threshold of , au spot density was defined as cut-off. data were analyzed by graphpad prism using two-way anova. results: semi-quantitative evaluation of analytes per array revealed significant differences. in plasma samples and platelets and analytes were detected above cut-off, respectively. in neonatal plasma we found more highly prevalent proteins (> , au spot density) compared to adult plasma ( / vs. / ). thirteen proteins were significantly elevated in neonatal plasma including growth/differentiation factor (gdf ), platelet derived growth factor aa (pdgf-aa) and serpin e (p < . ). more highly prevalent proteins were detected in npl ( / ) compared to apl ( / ), and proteins were significantly elevated including vascular cell adhesion molecule- (vcam- ), platelet factor (pf /cxcl ), epidermal growth factor and lipocalin- (p < . ). in adult samples only proteins were significantly higher in plasma and three proteins in apl compared to the neonatal groups (p < . to p < . ). summary/conclusions: we detected significant differences in regenerative growth factor and cytokine contents of neonatal and adult plasma and platelet samples, respectively. additional experiments are underway to further characterize their impact in distinct functional readouts. background: the production and storage conditions of platelet (pl) products intended for transfusion are constantly evolving and need sometimes in vivo evaluations in clinical trials to ascertain whether the platelets have retained their ability to survive in the circulation. this requires that the transfused platelets can be distinguished from the recipient's circulating platelets. labeling of platelets with biotin (bio) affords to track in vivo and concurrently, multiple cell populations covered with various biotin densities as already described for red blood cells (mock, transfusion, ) . surprisingly, there is only one study describing the transfusion of human biopl (stohlawetz, transfusion, ) . so far, the biotinylation reagent bio-sulfonhs was not complying with good manufacturing practices (gmp), which represents an obstacle regarding the regulatory authorities. aims: the aims of this study are ) to describe a procedure to label injectable human platelets with densities of biotin, ) to evaluate the impact of biotinylation on platelet functions, ) to track human biopl in the circulation of the mouse. methods: platelets are taken from standard platelets concentrates and treated with . and lg/ml biosulfonhs of gmp-grade, recently commercialized. main platelet functions are assessed in vitro. human biopl survival is evaluated in immunodeficient nsg-mice treated with liposome-clodronate to eliminate macrophages and to prevent rejection. circulating human biopl are detected ex vivo by flow cytometry with streptavidin phycoerythrin. results: using trap ( lm), p-selectin externalization reveals a normal capacity of secretion for all biopl. gpiba and gpiibiiia expression is not affected by the biotinylation process. biopl have the ability to aggregate: using arachidonic acid ( mm), amplitude of aggregation is . ae . % (bio ); . ae . % (bio . lg/ ml); . ae . % (bio lg/ml). using collagen ( . lg/ml), amplitude of aggregation is . ae . % (bio ); . ae . % (bio . lg/ml) . ae . % (bio lg/ml). the biopl populations could be easily distinguished between themselves and from unlabeled blood cells in the mouse circulation during more than h. after h, the mean fluorescence intensities are . ae . for unlabeled circulating mouse platelets, . ae . and . ae . for circulating human biopl covered respectively with . and lg/ml biotin. summary/conclusions: this labeling approach should be helpful to evaluate new platelet products in vivo and represents an alternative to radioactive tracers. it allows to follow simultaneously different platelet populations and consequently limits the number of volunteers in clinical trials. background: severe ocular surface diseases, dry eye syndrome, persistent and recurrent corneal epithelial defects and diabetic or neurotrophic keratopathy are mainly successfully cured by standard treatment protocols. however, not rarely does refractory to these usual treatments appear, especially with serious forms of disease. in military medical academy, autologous serum eye drops -auto seds and autologous platelet lysate -apl eye drops have been being applied in the treatment of ophthalmological patients in these categories, who were previously resistant to standard therapy. aims: to show the achieved results of therapeutic use of autologous blood products (auto seds and apl) in the treatment of ophthalmological patients who previously had not responded to conventional therapysingle center experience. methods: auto seds are prepared by taking autologous blood into tubes (bd vacutainer, cat, ml) and apl in tubes with anticoagulants (greiner bio-one, acd-a, ml). control on tti of every patient and sterility of every series has been conducted. before and after the treatment, subjective ocular discomfort (ocular surface disease index -osdi), objective parameters of the tear film (schirmer's test, rose bengal, tear breakup time -tbut) and measuring of epithelialization zone were analyzed. apl, obtained from platelet-rich plasma which had been frozen, unfrozen and diluted with nacl solution, up to %. auto seds were administered in the form of % eye drops. results: auto seds have been applied to ophthalmological patients ( men and women), previously resistant to standard therapy. in total treatments were performed (each lasted days). for successful curing, one or two treatments per patient, in average, were applied. apl has been used multiple times to one patient with sj€ ogren syndrome and severe multiple tropical corneal changes. all ophthalmological patients had subjective improvements (the average pre and post treatment osdi scores were . and . respectively). also, objective progress was present in % of all patients (p < . ). summary/conclusions: the use of auto seds and apl in the treatment of ophthalmological patients, previously resistant to standard therapy, is in constant increase, because of its simplicity and low expenses. apl has turned out to be better than auto seds for patients with severe trophic changes, because apl contains larger amounts of the nerve growth factor, tgf-b, vegf and platelet derived growth factor. however, a larger number of clinical cases is needed for future conclusions. background: whole blood (wb) has recently regained favor in treatment of massively bleeding patients in military and civilian settings. platelets (plts) are a vital component in clot formation. as a component of wb, it is critical that they maintain functionality throughout storage. red blood cells (rbcs) stored in hypoxic/ hypocapnic conditions preserve high level of , -dpg while reducing storage lesions stemming from oxidative stress. , on the other hand, effects of steady hypoxia (pco ~ - mmhg) on plts contained in leukoreduced wb is poorly characterized. aims: examine the effects of hypoxic conditions on plt function and microvesicle (mv) formation in wb stored hypoxically (h) and conventionally (c) for -week storage at - °c. methods: units of wb were collected at mayo clinic rochester blood donor center from normal healthy volunteers into ml cp d. wb was leukoreduced using plt-sparing filter (terumo wb-s) then split into control (c) and hypoxic (h). h-wb was processed by the oxygen-reduction bag (hemanext, lexington ma) and unit was stored in o -free bag. ml of wb were collected from each unit at day , weeks , , . plt counts, agonists (thrombin receptor agonist peptide (trap), adenosine diphosphate (adp) and collagen stimulated platelets aggregation, nonactivated and agonists activated plt surface expression of phosphatidylserine (ps, annexin-v binding), p-selectin, fibrinogen receptor (pac- binding), and microvesicles (mv) were measured by coulter counter and digital flow cytometer. paired student t-tests were used to analyzed differences in degradation rates; significance: p < . . results: h-plt counts declined to~ % by the o -reduction process, while similar decline was observed after week in c, and thereafter remained steady. plt activation (ps) increased over time (h >> c after processing; c increasing more rapidly during storage). p-selectin increased over time (h < c), while pac- showed large increase after week, then remained steady (h << c). plt activation by trap or adp declined modestly over weeks (~ %) while h-plt showed additional~ % reduction for all time points. collagen activation for c-plt increased after week ( %) and gradually increased to % after weeks (~ % reduction with h compared to c). plt-derived mv (cd and cd /annexin v) increased~ -fold over storage time; day mv levers were significantly higher for h, but subsequent increase rates were similar or lower. total number of plt-derived mv (cd a) in wb supernatant increased -fold after weeks for c, while h suppressed increase to -fold. (majority of the trends described above showed significant differences between h and c.) summary/conclusions: plts were activated over -week period when stored at - °c in leukoreduced wb, accompanied by a modest loss of agonist-induced activation. oxygen reduction treatment initially activated h-plts, while subsequent increase in activation rates were suppressed compared to c-plts. wb plts retained activatability, and hypoxic condition showed only modest further reduction on the activatability. hypoxic wb may provide higher quality wb for trauma patients if the levels of initial plt activation can improved during oxygen reduction procedure. methods: after informed consent, eligible patients were randomized to either first receive autologous followed by allogeneic seds or first receive allogeneic followed by autologous seds. each sed treatment phase was one month, separated by one month of patient's standard treatment (wash out period) between sed treatment phases. the patients each donated ml whole blood from which the autologous seds were prepared. allogeneic seds were prepared from blood from never-transfused male donors with blood group ab. all serum was diluted : by adding saline, and aliquoted in an eye drop dispensing system (meise, schalksm€ uhle, germany). at each visit, the osdi was determined using a validated questionnaire, with higher scores reflecting poorer outcomes. the results were analyzed intention-to-treat, and a random effects linear mixed model for cross-over design was used. results: in total, patients were enrolled, of whom were excluded because they failed the autologous blood donation. background: the following blood components for non-transfusional use (bcntu) are produced in our transfusional center (tc): ) allogeneic platelet gel (pg), derived from buffy-coats (bc) and human cord blood platelet gel (cbpg); ) autologous serum eye drops (sed). the creation of both types of platelet gel started in but only in we confirmed the process for daily production: these blood components are used to treat pediatric patients with epidermolysis bullosa. the sed, produced from , is dedicated to treat patients with dry eye syndrome. aims: production and storage bcntu. methods: the whole process production of bcntu is traced on the transfusional informatic system (emonet-insielmercato), under the same conditions of another blood transfusional components. the process takes place in closed circuit using the laminar flow hood. ) pg production starts from the bc resuspended in plasma that are not used for daily platelet concentrates, instead the cbpg is produced using cord blood units that are not used for hematopoietic transplant. both have a platelet concentration between - /ll and negative blood cultures, required by the italian law; the units are frozen at À °c and last -year. pg and cbpg must be activated with calcium gluconate or batroxobin to be used. ) the ophthalmologist's patients, with dry eye syndrome, donate ml of autologous blood; the serum is separated and after the dilution with a balanced saline solution ( %) are divided in boxes containing single-dose vials each: they are stored at À °c and they last one year. negative blood culture was evaluated. results : background: candida albicans is the most common pathogen detected in fungal infections. aims: in this study, we aimed to evaluate the in vitro antifungal activity of volunteerderived platelet rich plasma (prp) against c. albicans atcc strain and the possible effects of certain chemokines, kinocidins that might play a role in this activity. methods: prp from nine volunteers were derived by using magellan prp â kit. % calcium gluconate was used to obtain autologous thrombin. c. albicans isolates with a final yeast concentration of cfu/ml and cfu/ml were inoculated on sabouraud dextrose agar at the st , nd , th , th and th hours of incubation to reveal the antifungal activity of autologous thrombin-activated prp. the colonies were counted after - h of incubation at °c. chemokines and kinocidins (platelet factor- , interleukin- and thymosin-b ) were also measured simultaneously by elisa method. results: compared with the pbs-control group, the prp- group showed that the antifungal activity was still going on at the th hour. the difference in colony production between the two groups at th hour was statistically significant (p < . ). it was observed that the antifungal activity continued at the th hour, decreased at the th hour in the group prp- group. although the same amount of prp was used and the same amount of chemokine and kinocidins were released in both groups, the concentration of c. albicans was considered to be important in the detection of more effective prp- group. although there was an increase in il- levels by hours in the two prp groups by elisa method, no antifungal effect was detected against c. albicans. it was observed that decrease in tmsb values results from the antifungal activity on the advancing hours in the prp groups. whereas pf- did not act an antifungal activity on prp- and prp- . summary/conclusions: even in our study group where the highest platelet counts were obtained at the lowest concentration, c. albicans reproduction could not completely eliminated as mentioned in the literature. repeated doses of prp applications, such as drugs used in patients, may have longer duration of action and even complete repression of reproductive outcomes. background: generally, blood is available in developed countries for transfusion. sometimes, transfused or previously pregnant patients form alloantibodies to red cell antigens and rarely, to antigens of high prevalence. this case focuses on a twoyear-old girl, of pakistani descent, diagnosed with neuroblastoma stage iv with anti-in b and -e. although the publications indicate that % of the pakistani, indian or iranian populations are in(b-), it was discovered that this blood type is exceedingly rare. an international search was required to ensure blood product availability for chemotherapy and autologous hematopoietic progenitor cell transplants aims: illustrate the response of the public to a powerful story of a child needing rare blood for treatment and international collaboration for provision of very rare units. methods case report: a two-year-old patient's sample was referred for antibody identification. the patient had received four transfusions ( ml of red cells) in the preceding -day period. hgb level fluctuations were consistent with decreased transfused red cell survival. following the last transfusion of ml, the hemoglobin decreased from . to . . anti-in b , and a ficin-only reactive anti-e was identified in the serum and anti-in b in the eluate. the monocyte monolayer assay predicted the anti-in b to be clinically significant ( % reactivity). transfusion of antigen neg units once obtained, resulted in a stable transfusion response. although it was expected that in(b-) blood would be more easily sourced, only two donors in the usa were in (b-) e-. as - units of blood were requested for the post-transplant period, a national and international search was initiated, as was a robust media appeal to donors resulting in many donors for an intense domestic screening effort in the usa. the search of the who international rare donor panel by the international blood group reference laboratory revealed three known in(b-) e-donors; two british and one australian. they were contacted, recruited, collected and shipped to the usa with the work of the american rare donor program (ardp) staff and the isbt working party on rare donors (isbt wprd) members in each of the countries. results: the intense media coverage of oneblood (the florida blood center collaborating on treatment with the hospital) included online news outlets (youtube, facebook) resulted in over , responses from national and international potential donors to be tested for in b . isbt wprd members were sent the web information of potential donors identified in their countries by the ardp. over , samples from blood centers and associated laboratories tested with anti-in b by oneblood. two new in(b-) donors were discovered ( . %); but both typed e+, thus were not a match for the child. summary/conclusions: this intense media coverage and the overwhelming donor response was unprecedented in our experience. the coordination and cooperation among the numerous blood centers reflect the deep dedication of the blood banking community to the well-being of special patients in need. this case illustrates the response potential that a powerful story and a medical appeal for exquisitely rare blood utilizing social media and other online news outlets can generate. background: blood platelet units are generally stored in blood banks for - days, afterwards they are discarded. prepared infusible platelet membrane (ipm) from fresh or outdated human platelets correct the prolonged bleeding times in thrombocytopenic animals such as rabbits. infusible platelet membrane (ipm) as a platelet substitute may be the most feasible approach to reach the target market. our previous experiments have shown that ipm has a hemostatic efficacy to shorten bleeding time without any adverse effects in rabbits. aims: abnormal toxicity is the european pharmacopoeia standard for assessment of biological products which the test material is administered to the mice. in this study, abnormal toxicity of ipm was evaluated in experimental animal model such as mice to assure the safety of ipm without any evidence of serious toxicity. methods: in this experimental study, infusible platelet membrane (ipm) was prepared from outdated platelet concentrates. platelet concentrates were pooled, disrupted by freeze-thaw procedure, pasteurized for h to inactivate the possible viral or bacterial contaminants with a sodium caprylate stabilizer, formulated by sucrose and human serum albumin and finally lyophilized. at first, the test for sterility is carried out under aseptic conditions for ipm vials and then we injected . ml of ipm ( mg/kg) intravenously between to seconds into each health mice, weighing - grams. these tests were performed according to eu pharmacopeia monographs. results: in the sterility test no evidence of microbial growth in our product is found. the abnormal toxicity test will be passed if none of animals die during h after injection. if more than one animal dies, the preparation fails the test. if one of the animals just dies, the test is repeated. in our experiment all five mice were alive after h of ipm injection. summary/conclusions: in this research the results showed that ipm as a platelet substitute is free of abnormal toxicity with adequate safety and it may be used in human clinical trial studies as a feasible approach to develop a platelet substitute in the future. however, further studies are required to confirm the different aspects of its safety as well. the success of such investigations may affect patients' care in transfusion medicine in the future. a substantial number of infants, especially premature infants, are unable to receive adequate amounts of their mothers' milk for a variety of reasons. the world health organization recommends that infants, especially preterm and ill infants are fed with quality-controlled donor milk if they cannot be fed with their own mother s milk. due to the possible transmission of the human immunodeficiency virus many human milk banks closed in the s, therefore the availability of donor milk has decreased. aims: we analyzed the processing of donor milk and the required laboratory tests to establish a human milk bank within our blood donation service in cooperation with the department of neonatology at the frankfurt university hospital. methods: based on the recommendations for promoting human milk banks in germany, austria, and switzerland (efcni) we evaluated the manufacturing steps and the quality controls require to establish a human milk bank. background: for patients suffering from severe ocular surface disorders treatment with blood derived serum eye drops (sed) is a highly effective therapy. autologous sed, prepared from the patient's own blood, is used preferably. for this approach we have more than years of experience. if auto-sed cannot be manufactured due to medical reasons allogeneic sed present an alternative. since years, the allogeneic approach is well established in our center. aims: retrospectively evaluation of our experience with allo-sed. methods: in germany manufacturing of allo-sed is only possible as an "individual healing attempt". for each patient experienced regular ab -identical male donors without blood borne disease, who never received blood products and not taking any kind of medication are selected. additionally, donors must pass a questionnaire excluding any form of dry eye syndrome. allo-sed are manufactured directed for each individual patient according to the process for auto-sed in a closed system. patient files of our serum eye drops donors were screened for patients receiving an allogeneic treatment. data concerning indication for allo-sed, contraindication for phlebotomy, problems with donor selection and manufacturing, as well as serological and microbiological testing results were obtained. clinical results were evaluated © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - by ocular surface disease index (osdi) and patient's questionnaire, asking for subjective benefit, symptom reduction, possible side effects, consumption and comparison with artificial eye drops or, if applicable, with auto-sed. furthermore patients are undergoing regular ophthalmologic examination within a special consultation for dry eye syndrome at our hospital. results: patients were identified receiving allogeneic sed, patients had been treated autologous previously. in total, allogeneic sed have been produced times since june . indications were ocular gvhd (n = . %), neurotrophic keratopathy (n = . %), mucous membrane pemphigoid (n = . %), sj€ ogren syndrome (n = . %) and secondary keratoconjunctivitis sicca by virtue of chemotherapy, meige syndrome, rosacea, morbus bruton (n = . %). contraindications for autologous donation were underlying disease (n = . %), poor venous access (n = . %), low haemoglobin (n = . %), low body weight (n = . %), very young age (n = . %), circulatory disturbances (n = . %) and lack of response to auto-sed (n = . %). some patients presented more than one contraindication. manufacturing problems were: lipemic donor plasma (n = . %), high donor haemoglobin (n = . %) and unspecific positive serological findings (anti-hbs n = . %). microbiological testing was sterile every time. as side effects one case of allergic reaction, suspected as serum protein allergy, appeared. clinical outcome can be considered equivalent to ased. subjectively, all patients benefited from the therapy and reported an alleviation of their symptoms. for some indications (highly active gvhd) allo-sed might even be the better option. summary/conclusions: considering our previous experience, allo-sed seem to be a safe and equally effective alternative to auto-sed for patients unable to donate blood. in case of urgent indication, timely supply can sometimes be difficult. to overcome this disadvantage licensing allo-sed as a new blood product with the possibility of production and storage in advance would be a desirable goal. in addition supply would become even safer by preparing allo-sed according to a quarantine principle like ffp. abstract withdrawn. background: vernal keratoconjunctivitis is a chronic, recurrent bilateral inflammation of the outer ocular layer. mostly affected are children and young people and the condition is more common in boys. the disease presents with eye pruritus (itching eye), photophobia (sensitivity to bright light), excessive tearing and foreign eye syndrome. severe cases manifest with diffusion of overgrown papillae usually of the upper eyelid, bursting of the connective tissue barriers and appearance of giant papillae that press on the cornea. corneal ulceration is a severe complication of vernal keratoconjunctivitis that may induce scarring, corneal neovascularization and occasionally perforation. treatment of keratoconjunctivitis mainly relies on steroids, mast cell stabilizers, antihistamines, immunosuppressive drugs (cyclosporine), artificial tears, contact lensdressing, cryotherapy and surgical papillae removal. we present the case of a year-old girl with corneal ulceration who was applied artificial tears after traditional methods of treatment proved unsuccessful. aims: the aim was to share our experience on artificial tears therapy applied in ophthalmic disorders. methods: autologous blood ( ml) was collected into disposable, sterile transfer bags used for routine blood component preparation (no anticoagulant) and incubated for h at °c. the clot was then removed by centrifugation and the serum containing erythrocytes was press extracted. centrifugation was applied again to obtain serum free of cellular components. the serum was then divided into . ml segments (capsules)and the artificial tears applied to the left eye daily. results: ulcer healing was reported after weeks of therapy with artificial tears. the dosage was reduced to daily. no recurrence of corneal ulceration was observed after subsequent weeks. summary/conclusions: artificial tears are a safe and effective therapy for ophthalmic disorders in children. background: arv non-disclosure among hiv-positive donors who tested hiv antibody (ab) positive but rna negative (ab+/rna-), so-called false elite controllers, was previously described by our group in south africa, with > % of ab+/rnadonations since testing arv positive. the extent of undisclosed arv use at time of donation represents a significant risk to blood safety in a country with a growing treated hiv population. aims: to establish the prevalence of arv non-disclosure among four subgroups of hiv-positive donors in south africa along with demographic correlates of non-disclosure. methods: south african blood donors are screened by a self-administered questionnaire, which includes questions on current hiv status and arv use, followed by a semi-structured personal interview. specimens for hiv, hepatitis b and c testing are collected at time of donation. based on id-nat (procleix, grifols) and antibody (prism, abbott; western blot) testing, hiv-positive blood donations were classified as acute (ab-/rna+), recent (ab+/rna+, limiting antigen avidity [lag] odn ≤ . ), longstanding (ab+/rna+, lag odn > . ) and potential elite controller (ab+/rna-) cases. stored plasma from these donations were tested for four arv drugs using qualitative liquid chromatography-tandem mass spectrometry (detection limit . lg/ml). chi-square tests were used to assess associations of hiv case type, gender, ethnicity, age, donor type, and donor clinic (fixed, mobile) type with arv non-disclosure. results: during , donors tested hiv-positive of whom had samples available that were tested for arvs. the overall prevalence of undisclosed arv use was . % (n = ) with efavirenz most frequently detected ( ), followed by lopinavir ( ) and nevirapine ( ) . potential elite controller cases had the highest proportion of detectable arv ( / ; %) (p < . ) followed by longstanding ( / ; . %) and recent ( / ; . %) infections. none of acute hiv cases tested positive for arvs. there were no associations between arv use and gender or ethnicity. however, older ( to years) hiv-positive donors ( / ; . %) were significantly more likely to test positive for arv than younger ( to years) donors ( / ; . %) (p < . ). arv use was more frequent among first time ( / ; . %) than in lapsed ( / ; . %) or repeat ( / ; . %) donors (p < . ). donors at mobile clinics had significantly higher arv non-disclosure than donors at fixed sites ( . % vs . %; p = . ). summary/conclusions: the . % prevalence of undisclosed infection and arv use among hiv-positive south african blood donors is alarming. higher rates of nondisclosure among first-time donors was expected, but non-disclosure among repeat and lapsed donors suggests failure in donor education and assessment. the . % prevalence among concordant ab+/rna+ cases may suggest sub-optimal viral suppression. lack of detection of arvs in acute cases should be qualified because the samples were not tested for tenofovir, the most common drug used in pre-exposure prophylaxis. donor motivation for non-disclosure of known hiv infection and arv use needs further investigation, since early arv initiation or infection while on prep could lead to low ab and rna levels, failure to detect hiv-infected donations and transfusion-transmission of hiv. blood bank, rotary blood bank, new delhi, india background: voluntary blood donation ensures safe blood transfusion. careful blood donor selection is of importance to provide safe blood to patients, although new methodologies have also been adopted by blood centers for blood safety and to minimize risk of transmitting infections through blood transfusion. the quality and the availability of blood components depend on the willingness to donate and reliability of the information given by the donors about their own health, including risk behaviour. blood donor history questionnaire is designed to evaluate donor's history in accordance with the guidelines laid down by the fda. donors, once deferred by the blood bank, will be less motivated to return for donation if he is not counseled effectively. it is important to reduce the number of deferrals by good donor comprehension and the centre should have a mechanism to recall temporarily deferred donors aims: the aim of the study is to analyse donor history and test results of those who donated blood with past history of jaundice. based on their history which suggested the type of viral infection they had, these donors were accepted or deferred. data was collected from voluntary blood donors who were screened for blood donation in the year . methods: in this study, donor history was analysed with reference to history of jaundice. jaundice in donors after the age of yrs, history of surgery, blood transfusion, body tattoos and acupuncture treatment within past one year of donation, history of multiple sex partners and related history and intravenous drug abuse history was taken into consideration. donors who revealed past history of jaundice were asked in detail about their illness and recovery. blood was donated by donors from whom the history of jaundice was elicited and it was understood that the type of virus which caused jaundice was not hepatitis b or c. those who could not give the correct history or were not sure of the cause of hepatitis, those individuals were deferred. aims: to assess the performance of this follow-up program in terms of donor participations, successful confirmed positivity rates, and potential reentry rates. methods: eligible donors were tested for hbsag, hcvab, hivab/ag, and tpab with two eias for each marker. samples reactive with at least one assay were tested further with electro-chemiluminescence assay (eca) and reactive samples were considered repeated reactive (rr). tpab reactive donations were re-tested with particle agglutination assay (tppa). samples eca or tppa non-reactive were considered non-repeatable reactive (nrr background: the blood donation service in suhl processes more than . samples annually from whole blood and apheresis donations, testing on average around samples per day. for the last years, serology screening was performed on the architect instruments (abbott) (arc), but will be changed to the alinity s system (aly) by middle of . although the design of the aly assays is based on those of the arc assays, we undertook a thorough evaluation of the four mandatory screening assays detecting hbsag, hiv ag/ab, anti-hcv and anti-hbc. aims: to validate the mandatory screening assays on the new aly system in our lab in terms of sensitivity and specificity, also including samples with known falsereactive results. determine the rate of false reactive results for hbsag, anti-hcv and anti-hiv that may lead to deferrals of donations and donors. methods: for sensitivity, we used known positive samples confirmed by immunoblot or nat. known unspecific positive samples for arc not confirmed by immunoblot or nat were testes for aly also. close to . unselected samples (edta plasma) from routine blood and apheresis donors were tested in parallel on both systems, arc and aly to determine the rate of initial and repeat reactive results. results: all known confirmed positive samples were identical detected by aly. samples with known unspecific reactive results were retested by aly with the following results: / anti-hcv, / hiv ag/ab and / hbsag were found reactive by aly to. one donation from an acute hiv infection in the early seroconversion period was detected by both methods in routine testing. there are no reactive results for aly not already known for arc. the specificity for the screening assays on aly versus arc assays were as follows: ) hbsag aly . % ( % ( / % ( ) vs arc . % ( % ( / ; ) hiv aly and arc . % ( / ); ) anti-hcv aly . % ( % ( / % ( ) vs arc . % ( % ( / . the number of anti-hbc reactive samples did not differ between aly and arc. summary/conclusions: while the switch to the new system is mainly driven by operational efficiency, obviously, the high specificity of the alinity s assay will reduce unnecessary deferrals of donations and donors. abstract withdrawn. background: blood donor selection is the cornerstone for blood transfusion safety, designed to safeguard the health of both donors and recipients. donor safety is targeted by reducing the risk of complications associated with blood donation and transfusion safety by reducing the risk of transfusion-transmitted infections (tti) and other preventable transfusion reactions. there is always a compromise on blood donor safety as well as blood safety during outdoor mega blood donation drives due to various reasons, mainly due to more number of donations within a stipulated time. aims: to compare the blood donor selection patterns between in house blood donations and donations at mega blood donation drives and its influence on donor safety and blood safety in a tertiary care hospital in india. methods: a retro prospective study was done to audit and compare blood donor safety and blood safety over a period of years from january to december . blood donor safety was analyzed by two indicators: donor health questionnaire (dhq) monitoring and blood donor reaction rates and blood safety through tti positivity rates. ( ) during mega blood donation drive. summary/conclusions: a good donor selection is a lengthy process which involves pre-donation information and advice: this is usually provided in a leaflet, especially about transfusion-transmitted infections (and the associated risk factors) and the potential risks of donation, filling of dhqs by the donor himself, donor interview: conducted by a qualified medical specialist trained in donor selection process and health assessment at the end of the interview to declare if the donor is eligible to give blood or deferred temporarily or permanently. it was observed that seroprevalence rates, number of donor reactions and incompletely filled dhqs were more among blood donations at mega blood donation drives when compared to blood donations during in house collections. this is mainly due huge number of blood donations with in a stipulated time where there is limited time spent on proper donor selection. stringent implementation of who strategy: "safe donor safe blood" is the only way for blood donor and transfusion safety. background: safety of blood transfusion is a great concern especially in crisis countries and during humanitarian emergencies. transfusion transmitted infections (ttis) are one of the major health problem in yemen that are associated with blood transfusion complications. aims: the aim of this study is to determine the prevalence of ttis among blood donors at national blood transfusion and researcher center (nbtrc this contributed to an additional reactivity of . %, thereby total reactivity being . %. % ( / ) of these were hcv reactive & % ( / ) for hbv. the nat yield was in and the viral loads of nat reactives ranged from - x iu/ml for hcv & all the hbv yields had an extremely viral load of < iu/ml. / nat reactive showed sero-conversion after - months with follow-up eclia screening, and of these were hcv reactive and hbv reactives. summary/conclusions: incidence rate indicate that the current risk of transfusion transmitted viral infections attributable to blood donation is relatively high in our country. parallel use of both serology and nat screening of donated blood in countries that have high seroprevalence can improve the blood safety. at our centre, by using best in class serology and nat technologies, we were would add an extra layer of safety to blood supply by interdicting samples from donor with recent infections. abstract withdrawn. abstract withdrawn. ( / , ) . the both hiv-rna and hcv-rna detected donors by nat were identified in the window period. summary/conclusions: in this study, we found that nat could detect infected cases with hbv-dna, hiv-rna and hcv-rna which were forgotten by serological methods therefore, nat is a sensitive screening method to detect low viral load and shorten the window period of the virus infection to ensure the safety of blood transfusions. service du sang, croix rouge de belgique, namur, belgium background: due to enhancement of kits specificity and machines throughput, roche elecsys â technology is a potential partner for blood donations screening laboratories. aims: the aim of the study was to assess the performance of the elecsys serology assays on a cobas e equipment for clinical specificity, analytical sensitivity and reproducibility. background: deceased donors are the primary source of organs and tissues for transplantation but the risk of infectious complications in the recipient is high and is the main cause of morbidity and mortality after transplantation. to minimize the risk of infections by organ or tissue transplantation, donors should be tested for anti-hiv- / , hbsag, anti-hbc, anti-hcv, and syphilis. further laboratory tests may be required depending on the history of the donor and on the tissue properties. certain grafts can be donated after circulatory death of the donor; however, the absence of the heartbeat may change dramatically the blood composition by e.g., haemolysis and proteolysis. this may have an impact on test performance and lead to false results. therefore, an assay validation is needed for testing of cadaveric samples. aims: a validation study was performed to demonstrate the suitability of elecsys hbsag ii, anti-hbc ii, anti-hcv ii, hiv combi pt, hiv duo, syphilis, htlv-i/ii, and chagas for the use in cadaveric samples from non-heart beating donors. methods: as the basis for validation, we followed the recommendations of the paul-ehrlich-institut (pei) "proposal for the validation of anti-hiv- / or hiv ag/ ab combination assays, anti-hcv assays, hbsag and anti-hbc assays for use with cadaveric samples". comparison of spiked samples from living donors and cadaveric donors was used to demonstrate accuracy. to determine precision, two cadaveric specimens were tested in several replicates. acceptance criteria were implemented according to the pei recommendations. results: results were found to be within specifications requested by the pei recommendations for all tested assays summary/conclusions: the evaluated results support the extension of the use of these assays with cadaveric specimens. background: in developed countries, blood donors are routinely screened for a range of blood borne viruses (hiv, hbv, hcv and htlv) using highly sensitive screening tests. this has dramatically improved the safety of blood supply. however, transmission by transfusion of unknown or unsuspected viruses remains a continuing threat. this is particularly relevant considering that a significant proportion of transfused patients are immunocompromised and more frequently subjected to fatal outcomes. in developed countries, blood donors are routinely screened for a range of blood borne viruses (hiv, hbv, hcv and htlv) using highly sensitive screening tests. this has dramatically improved the safety of blood supply. however, transmission by transfusion of unknown or unsuspected viruses remains a continuing threat. this is particularly relevant considering that a significant proportion of transfused patients are immunocompromised and more frequently subjected to fatal outcomes. aims: in this context, metagenomic analyses of viral content in blood donations collected in geographical zones recognized as "hotspot" for viral emergence represents a suitable approach without any a priori for the identification of a potential emerging viral risk that may compromise blood safety. methods: in the framework of a viral discovery program founded by the french national agency for medicine security (ansm in french), more than plasma samples collected in sub-saharan africa countries ( ) ( ) and the amazon region of brazil ( ) have already been analysed by metagenomics. results: although no viral sequence could be described as novel (i.e. new species or even a new genus), we unexpectedly identified a feline bocavirus in two donors from mauritania. a large diversity of known viruses that are not part of the regularly monitored agents were also observed, among which anelloviruses, hpgv- (formerly known as gbv-c), papillomaviruses, herpes viruses, parvovirus b , chikungunya virus, enterovirus, and various small circular viruses (circo-, cycloand gemycircularviruses). while no significative differences was observed in the higher classification of detected virus (above families/genera) between africa and brazil, we observed variations at the sequence level allowing better resolution of the genetic diversity for several viruses (for example characterization of hpgv- genotypes). summary/conclusions: overall, the absence of novel viruses in blood samples collected across countries of two distant continents is reassuring regarding threats emergence. however, continuous monitoring of prospective blood banks should be continued. summary/conclusions: after the high peak observed in during the first period, this study shows that the decrease in the seroprevalence of viral markers is continuous over the next five years. the second period is marked by an irregular evolution of seroprevalence but with lower levels than the first period. the recruitment of new donors allows a quantitative increase in donations. however, improving the quality of blood products essential condition of transfusion safety is achieved through retention of recruited blood donors. background: in blood screening laboratories, samples may be transferred between automated serological and molecular instruments, and the potential for sample contamination is a serious risk to the integrity of nucleic acid testing (nat) results. the sensitive limit of detection (lod) for hiv and hcv nat assays combined with the high viral titers encountered in specimens from patients with acute infections presents a challenge for maintaining the sample integrity of negative specimens. at additional cost per test, this risk can be reduced with single-use filter pipette tips. aims: we evaluate the efficacy of applying induction heated washes to a non-disposable pipettor on serology instruments-alinity s, alinity i, and architect i sr (abbott diagnostics)-to preserve the integrity of samples transferred to a downstream molecular instrument, the m realtime (abbott molecular diagnostics), which amplifies viral nucleic acid targets exponentially. methods: in this application of induction heating, the metallic pipettor warms under its own resistance to coil-induced electrical currents. by sweeping the pipettor through an induction coil, temperatures on the pipettor are elevated throughout its length. single donor high viral titer hiv genotypes a ( . log iu/ml), b ( . log iu/ml), c ( . log iu/ml), crf ( . log iu/ml), crf ( . log iu/ml), and urf ( . log iu/ml), as well as single donor high viral titer hcv genotypes a ( . log iu/ml), b ( . log iu/ml), a ( . log iu/ml), ( . log iu/ml), q ( . log iu/ ml), and t ( . log iu/ml) were used as potential sources of contamination; these genotypes account for the majority of hiv and hcv infections worldwide. on serology instruments, one high viral titer hiv or hcv specimen and three consecutive susceptible negative samples (hiv/hcv rna negative human plasma, abbott molecular diagnostics) were tested on an hiv ag/ab combo or anti-hcv immunoassay (abbott diagnostics), and this schema was repeated four times per positive specimen. induction heated washes occurred between all samples processed on the serology instruments. the first susceptible negative from each testing block, with approximately ml of residual sample volume, was then tested using the . ml abbott realtime hiv assay (lod copies/ml) or . ml abbott realtime hcv assay (lod iu/ml) and an hcv ag immunoassay (lod . fmol/l; abbott diagnostics). study acceptance criteria required that any susceptible negative sample had no detectable level of hiv or hcv rna. results: all first susceptible negative samples (n = per platform per virus schema) run on alinity s, alinity i, and architect i sr using induction heated washes after a high viral titer hiv specimen or hcv specimen were hiv ag/ab combo nonreactive (< . s/co) and reported no detectable level of the hiv rna target, or were anti-hcv nonreactive (< . s/co) and reported no detectable level of the hcv rna or core antigen targets. summary/conclusions: while precautions should continue to be taken for samples run on molecular instruments, the integrity of samples originally tested on the alinity s, alinity i, and architect i sr was preserved for downstream molecular testing through the use of induction heated washes. aims: increasing the safety of blood and blood products -motivating the blood donors to be regular donors methods: national reporting system showed the high prevalence of ttis among first blood donors in compares with the regular donors. in per . . donations, % % of confirmed positive hiv, % of hcv, and % of hbv cases has been reported among first blood donors. in the end of a national program named "pre-donation screening tests "has been developed and has been implemented in high prevalence provinces in whole country. based on this program, all first blood donors who accept in donation sites, if after donor selection process are eligible to donate blood, they refer to give just a blood sample for screening ttis tests. after months, the invitation letters and smss send to the donors who have negative results for all screening ttis tests, and they can be eligible to donate blood after another donor selection process. in , about . % of all donations have been rejected because of at least one of hiv, hcv, or hbv confirmed positive results, while this reject rate in was . %, which shows a significant decreasing the ttis prevalence among blood donation from to . the prevalence of hiv, hcv, and hbv among donations has been decreased significantly in compared with the . prevalence of hiv among donations reduce from . % in to . % in , for hcv and hbv the same results have been experienced, respectively from . % and . % in reduce to . % and . % in . it seems this applied study could effectively scale up the safety of national blood supplies. in addition this intervention could support iranian blood transfusion service to increase the proportion of regular blood donors from . % in to . % in . it means that with increasing the regular blood donor population sizes, the safety of iranian blood and blood products will be more and more scaled up. summary/conclusions: evidence based reports show there is a high rate of prevalence of transfusion transmitted infections (ttis) among first blood donors. so an effective intervention which can reduce the risk of unsafe first blood donation can effectively increase the safety of blood and blood products. pre donation screening tests program in iran can support the national program to decrease the rate of ttis among blood donations from . % in to . % in . abstract withdrawn. abstract withdrawn. background: despite the universal application of viral inactivation and elimination technologies during the preparation of plasma-derived products, the exclusion of infectious donations before any other procedure remains the first essential step as well as the major determinant for the safety of untreated labile blood products. current selection and screening techniques have reduced the risk of viral transmission to very low levels, but there is still a very low but quantifiable risk of transmission through donations beyond routine detection, particularly during the " seroconversion window". "of an infection in a blood donor that is to say during the period when the recently infected donor has not yet developed a serological response. the level of residual risk, which must be as low as possible, is mainly conditioned by the rates of the infections concerned (hiv and hepatitis b virus (hbv) and c (hcv)) to blood donors. summary/conclusions: the evolution of serologic markers is generally satisfactory with continued regression, which has improved particularly for hiv. on the other hand, hepatitis b is still a concern because of its still high rate among new donors. it is desirable to initiate a regular donor vaccination program to protect against hepatitis b. background: blood centres require high throughput assays with a high level of reproducibility to assure consistent results and minimize unnecessary retesting of samples and deferral of donors. in addition, continued economic pressures on laboratory operations demand that assays perform on platforms capable of increased walk away time and enhanced automation in areas of reagent management, retest options, and commodity/waste management. aims: evaluate the reproducibility of hcvab, havab igm and havab igg essays using abbott alinity s when compared to architect i sr. determine repeatability of these tests in alinity s essays. methods: during months a study was conducted where several samples (minimum samples per test) were randomly sorted and tested using alinity s and architect i sr, results were compared using ibm spss statistics â . in order to evaluate repeatability, at least samples with different reactive degrees (high, intermediate and low) per test were repeated, using alinity s, an average of times per sample and it was determined the percentage of coefficient of variation (%cv). results: a total of samples were tested ( for hcvab, for havab igm and for havab igg) using alinity s and architect i sr, and it was ensured that there were no statistically significant differences between results (p > . ). using samples and a total of essays we found the %cv hcvab ranged from to . %. samples were tested for havab igm in a total of essays and the %cv ranged from to . %. havab igg was tested in samples during essays and the %cv ranged from to . %. summary/conclusions: the new automated equipment alinity s system demonstrated no statistically difference when compared with architect i sr and repeatability was ensured. this demonstrates the precision of results generated by this fully automated blood screening analyzer, which helps assure consistent results for the testing and retesting of blood specimens for hcvab, havab igm and havab igg. background: blood centres require high throughput assays with a high level of reproducibility to assure consistent results and minimize unnecessary retesting of samples and deferral of donors. in addition, continued economic pressures on laboratory operations demand that assays perform on platforms capable of increased walk away time and enhanced automation in areas of reagent management, retest options, and commodity/waste management. aims: evaluate the reproducibility of hbsag, hbsab, hbcab, hbeag and hbeab essays using abbott alinity s when compared to architect i sr. determine repeatability of these tests in alinity s essays. methods: during months a study was conducted where several samples (minimum samples per test) were randomly sorted and tested using alinity s and architect i sr, results were compared using ibm spss statistics â . in order to evaluate repeatability, at least samples with different reactive degrees (high, intermediate and low) per test were repeated, using alinity s, an average of times per sample and it was determined the percentage of coefficient of variation (%cv). results: a total of samples were tested ( for hbsag, for hbsab, for hbcab, for hbeag and for hbeab) using alinity s and architect i sr, and it was ensured that there were no statistically significant differences between results (p > . ). using samples and a total of essays we found the %cv hbsag ranged from - . %. samples were tested for hbsab in a total of essays and the % cv ranged from - . %. hbcab was tested in samples during essays and the %cv ranged from - . %. using samples and a total of essays we found the %cv hbeag ranged from . - . %. samples were tested for hbeab in a total of essays and the %cv ranged from - . %. summary/conclusions: the new automated equipment alinity s system demonstrated no statistically difference when compared with architect i sr and repeatability was ensured. this demonstrates the precision of results generated by this fully automated blood screening analyzer, which helps assure consistent results for the testing and retesting of blood specimens for hbsag, hbsab, hbcab, hbeag and hbeab. background: blood centres require high throughput assays with a high level of reproducibility to assure consistent results and minimize unnecessary retesting of samples and deferral of donors. in addition, continued economic pressures on laboratory operations demand that assays perform on platforms capable of increased walk away time and enhanced automation in areas of reagent management, retest options, and commodity/waste management. aims: evaluate the reproducibility of hivag/ab, syphilis and htlv i/ii essays using abbott alinity s when compared to architect i sr. determine repeatability of these tests in alinity s essays. methods: during months a study was conducted where several samples (minimum samples per test) were randomly sorted and tested using alinity s and architect i sr, results were compared using ibm spss statistics â . in order to evaluate repeatability, at least samples with different reactive degrees (high, intermediate and low) per test were repeated, using alinity s, an average of times per sample and it was determined the percentage of coefficient of variation (%cv). results: a total of samples were tested ( for hivag/ab, for syphilis and for htlv i/ii) using alinity s and architect i sr, and it was ensured that there were no statistically significant differences between results (p > . ). using samples and a total of essays we found the %cv hivag/ab ranged from to . %. samples were tested for syphilis in a total of essays and the %cv ranged from to . %. htlv i/ii was tested in samples during essays and the %cv ranged from . to . %. summary/conclusions: the new automated equipment alinity s system demonstrated no statistically difference when compared with architect i sr and repeatability was ensured. this demonstrates the precision of results generated by this fully automated blood screening analyzer, which helps assure consistent results for the testing and retesting of blood specimens for hivag/ab, syphilis and htlv i/ii. , human immunodeficiency (hiv) and hepatitis c (hcv) viruses' infection in blood donors were . %, . % and . % respectively. consecutive positive results for hbv were . % ( / ), for hcv were . % ( / ) and nil for hiv. there was no sample carry over in this. out of consecutive reactive donors were donated for same patients and were related with infected patient which were statistically significant (p < . ). summary/conclusions: among all tti reactive donors . % ( / ) were consecutive reactive. the reason for the same may be process related like sample carry over or reagent carry over or donor related. donor related reasons may be, one of the close relative is reactive for virus and that is transmitted to other family members. in our study reactive donors either had close contacts with persons with history of infective disease or were their first degree family relatives. these findings were found statistically significant (p < . ). this study recommends that in analysis of consecutive positive results in elisa along with looking for procedure/sample error, there is also a need to take retrospective history of donors for close contact with infected patient. background: screening for transfusion-transmitted infections (ttis) is critical in ensuring safety of blood products. transmission of infections through transfusion remains a major source of viral hepatitis especially hbv and hcv. the effectiveness of rapid immunochromatographic test (ict) devices for screening of blood is a concern and needs validation through advanced methods like chemiluminescence immunoassay (clia) and polymerase chain reaction (pcr). aims: the current study was conducted to evaluate the performance and screening effectiveness of commercially available rapid screening kits in comparison with clia and pcr. methods: this single centre, cross sectional study was conducted at the department of blood transfusion services, shaheed zulfiqar ali bhutto medical university, islamabad, from january -june . a total of ten commercially available ict devices and one clia kit (liaisonr xl) were tested for their sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy using positive and negative samples each for hbv and hcv respectively, in comparison with the values determined by pcr. the ict kits included hightop, rightsign, wondfo, accu-chek, fastep, abon, immumed, insta-answer, biocheck and ctk. results: the sensitivities and specificities of ict kits for hbsag were % and % (hightop), % and % (rightsign), % and % (wondfo), % and % (accu-chek), % and % (fastep), % and % (abon), % and % (immumed), % and % (insta-answer), % and % (biocheck) and % and % (ctk) respectively. similarly the sensitivities and specificities of different ict kits for hcv were % and % (hightop), % and % (rightsign), % and % (wondfo), % and % (accu check), % and % (fastep), % and % (abon), % and % (immu-med), % and % (insta answer), % and % (biochek) and % and % (ctk) respectively. the sensitivity and specificity of diasorin liaison murex assay for both hbv and hcv were found to be %, when compared with pcr. the ppv, npv and accuracy were determined accordingly. summary/conclusions: rapid testing ict devices for both hbv and hcv available in pakistan were found to have a variable degree of sensitivity and specificity, when compared with pcr. comparatively expensive but quality methods are more reliable as compared to rapid devices. the data generated will help policy makers to prepare future plan of action and introduce the concept of quality control in blood centres. the analysis has shown that the population of blood donors also included people infected with syphilis. in reference to the number of the tested samples this number is quite significant. the analysis proved the increase in the number of syphilis infections among the blood donors which is consistent with the general trend in the population. summary/conclusions: we have proved that testing blood donors for the treponema pallidum infection increases the safety of recipients of blood and its components and that obligatory testing of donors is fully justified. , and , the use of third or fourth generation serological assays is mandatory for screening of blood donor units for hbv and hcv infection before transfusion. routinely, blood banks in india screen the units by the elisa testing. nat is not very common due to cost constraints. aims: the aim of this study is to determine the frequency and load of hbv dna and hcv rna in hbs and hcv reactive blood donors respectively, and hence it was intended to contribute to determining whether routine hbs and hcv screening of blood donors, using elisa method alone, provides any concrete benefits with regard to hbv and hcv risk reduction or whether the implementation of nat will be of great benefit to low-resource countries like india, which has high prevalence of hbv and hcv. abstract withdrawn. , donors were routinely tested for hbv dna by using cobastaqscreen mpx- and mpx- (roche) or procleix ultrio and ultrio plus id (grifols) assays. obi was confirmed by repeat dna testing and by performing additional serological and molecular investigations on index and follow-up samples. anti-hbs concentrations were determined and anti-hbc antibodies were tested with three distinct commercial clia assays (anti-hbc elecsys roche, architect anti-hbc ii abbott, and hiscl anti-hbc assay sysmex). hbv pre-s/s, precore/core and bcp regions were pcramplified after viral particle concentration and viral amplicons were sequenced. results: hbsag-/dna+ donors ( : , ) including confirmed obi were identified ( : , prevalence). among obi donors, ( . %) tested anti-hbc+/anti-hbs-, ( . %) were anti-hbc+/anti-hbs+, ( . %) were anti-hbc-/anti-hbs+, and anti-hbc-/anti-hbs-primary obi ( . %). anti-hbc-/anti-hbs+ obi donors were significantly younger (mean: years [range: - years]) than those with anti-hbc+/anti-hbs+ (mean: years [range: - years]) and anti-hbc+/anti-hbs-(median: years [range: - years]) profiles (p < . ). hbv vaccination was documented for ( %) of these donors and was reported in one donor but without definitive evidence. extremely low hbv dna loads (range: < - iu/ml) were transiently detected in seven donors during follow up. genotypes identified were genotype b (n = / ) and genotype c (n = / ). preliminary analysis of core protein (n = ) and bcp (n = ) sequences showed no particular genetic feature that could be associated with altered antigenicity or core gene expression. follow-up was available for / anti-hbc-/anti-hbs+ donors ( - samples/donor; range: - months). anti-hbc remained undetectable with all clia assays in these donors except one. low transiently detectable levels of hbv dna were observed overtime with anti-hbs levels fluctuating between and , iu/l. no significant difference in hla-a, -b (except hla-b* more frequently detected in anti-hbc negative obi), and -drb *. summary/conclusions: overall, the . % prevalence of anti-hbs-only in hbv dna positive obi carriers ( : , of total donors) in dalian blood donors confirmed previous reports from south east asia. this phenomenon was not related to core antigenic variations but was significantly associated with younger age of carriers. a particular route and natural history of the infection may be considered. the hypothesis of acute-phase vaccine breakthrough was ruled out in / donors by the over months stability of this serological profile. breakthrough in immunized donors may still be suspected. further studies are needed to evaluate the potential infectivity of anti-hbs-only/hbv dna+ obi carriers, and to characterize the potential viral and immunological mechanisms responsible for this unusual hbv infection profile. confirmatory laboratory, hungarian national blood transfusion service (hnbts), budapest, hungary background: vaccination against hepatitis b virus (hbv) is an effective tool to avoid the infection. in hungary, population born after is considered to be immunized, because inoculation has been mandatory for children as campaign vaccination since . hbv vaccine is strongly recommended for healthcare workers, moreover trips to endemic countries and awareness of individuals could also be reasons of vaccination in immunologically na€ ıve age-groups. since the hbv vaccine contains surface antigen, a recent inoculation can cause reactivity of hbsag screening assays and positivity of confirmatory tests for several days resulting in deferral of donors from blood donation. the former regulation of hnbts, which was valid until december , , allowed the re-entry of donors whose immunization records and negative hbv confirmation of the second blood samples proved that the previous vaccination had resulted in the hbsag confirmed positivity. aims: the aim of this study was to strengthen that vaccination against hbv before blood donation had resulted in the reactivity of hbsag screening and confirmatory assays between and . background: in brazil, the introduction of nucleic acid tests (nat) for hbv-dna detection in the routine screening at public blood banks is relatively recent. at fundac ßão pr o-sangue/hemocentro de são paulo (fps-sp), about , blood donors are submitted to serological screening tests (hbv, hcv, hiv- / , chagas disease, syphilis and htlv- / ) and nat for hiv, hcv and hbv per year. approximately % of the blood donations are discarded due to some reactive result; of these, the hbv discard rate was . % in . aims: our study aims to determine the potential infectious cases among samples that had one or more hbv-reactive screening results (anti-hbc, hbsag and mp-nat-hbv) and verify the different categories of hbv infection (acute, chronic, occult hepatitis b infection (obi) and immunological window). furthermore, to characterize the distribution of hbv genotypes, drug resistance and escape mutations and analyze the risk factors. methods: we carried out a cross-sectional study of roughly , donations from may to december . hbv antibodies and antigen screening were performed using cmia kits architect â -abbott/hbsag and architect â -abbott/anti-hbc. nat screening was performed in minipools (mp) of six samples using kit nat hiv/hcv/ hbv -bio-manguinhos (sensitivity % lod iu/ml for hbv). reagent samples (n = ) that presented one or more hbv-reactive screening results (anti-hbc, hbsag and/or mp-nat-hbv), were submitted to individual nucleic acid extraction and "in house" quantitative real-time pcr-hbv (id-pcr-hbv) targeting the hbsag region (sensitivity - ui/ml). the hbv genotypes and mutation analyses were determined by direct sequencing of the hbv pol-gene/surface-gene and use of the online analysis tool geno pheno [hbv] . . socio-demographic and epidemiological data were also analyzed. financial support: fapesp / - . results: among the hbv reactive samples, were reactive for anti-hbc only ( . %), for hbsag only ( . %) and were reactive for both markers and hbv dna ( . %). routine testing and id-pcr-hbv identified ( . %) samples of active infections that had all hbv reactive/positive tests results. no hbv dnayield samples or hbsagyield or obi were observed. viral loads for active infections samples ranged from . e+ to . e+ cop/ml (median, . e+ cop/ml). hbv sub-genotypes a , a , c , d and f were found in %, %, %, %, and % of the donors, respectively. no reverse transcriptase inhibitor-resistant variants were detected. escape mutations in small hbsag protein shb region were detected in % ( / ), with the following main substitutions c ( x), r, n and g. the mean age of donors with active hbv infection was years, mostly donors were males ( %), mixed ( %) or white ( %) and had concluded high school ( %). summary/conclusions: discard rate due to isolated anti-hbc is high but no obi was found in the blood donor population studied. in addition, no case of immunological window for hbv or hbsagyield was detected. there was a predominance of subgenotype a and mutations associated with escape were found in % of hbv-dnapositive samples. continuous research and surveillance about hbv prevalence among blood donors are needed to maintain and evenly increase blood safety in brazil. background: screening for anti-hbcore antibodies in blood donors is considered to contribute significantly to blood safety, since it reveals donors with occult or probable occult hepatitis b, with variable results in molecular screening, due to very low viral load. however, universal anti-hbcore testing in blood donors, might exclude a considerable number of blood donors in countries with high hbv prevalence and even in countries with low to moderate prevalence, like greece. aims: the aim was to investigate the percentage of blood donors with natural hbv infection (confirmed positive anti-hbcore) or hbv immunization due to vaccination (anti-hbs+ only, due to vaccination) and predict the impact of generalized anti-hbcore testing. methods: during the period - november , all blood donors were asked to give their consensus for additional screening for hepatitis b anti-hbcore and anti-hbs antibodies, besides the obligatory serological and molecular screening, the samples of few donors who disagreed, were not examined. all samples with repeated positive anti-hbcore results, were further examined for anti-hbcore igm and anti-hbe antibodies. furthermore, a new donor sample was requested, to confirm reactivity. the serology results were recorded in an excel spreadsheet. additional data, including age, sex, nationality, number of previous blood donations, abo blood group, family history of hbv infection, hbv vaccination, were also recorded and statistically evaluated. donors were informed of the positive results. results: a total of edta samples were tested using the architect anti-hbcore, anti-hbs, nti-hbcore-m and anti-hbe assays (chemiluminescent microparticle immunoassay (cmia). repeated anti-hbcore(+) occurred in ( . %) samples, among which ( %) were also anti-hbe(+), while anti-hbs was found > m iu/ml in ( . %), between and miu/ml in ( . %), and < miu/ml in ( %). among anti-hbcore positive donors, / were foreigners ( . %) and were greeks, while foreigners consisted , % ( / ) of donors examined. so, anti-hbcore was found positive in , % of foreigners ( / , all from countries with high prevalence for hepatitis b infection) and in , % of greeks ( / ). in total, ( . %) samples had anti-hbs > miu/ml (considered seroprotective for the donor). summary/conclusions: almost half of our blood donors ( . %) were immunized, by vaccination and ( . %) by natural infection. the incidence of natural infection was significantly higher in foreigners ( . % versus , %). if not all anti-hbcore+ donors, % with anti-hbs < iu/ml, might be potentially infectious, especially for immunocompromised patients. if we choose to screen all blood donors for anti-hbcore and reject those with positive results, regardless of the anti-hbs levels, we would probably lose a significant number of donors and jeopardize blood sufficiency. alternatively, we could reject only those with anti-hbs < or < , or choose to selectively screen pre-donation blood donors from countries with high prevalence of hbv infection. following this pilot study, the prevalence of immunization against hbv in large numbers of blood donors from various parts of greece, must be investigated, in order to decide whether to introduce such screening. aims: the aim of this study was to perform phylogenetic analysis of the donor samples with hcv found in the neighbouring villages to determine the nature of transmission. methods: altogether, approximately million blood donor samples were screened with anti-hcv immunoassay (architect anti-hcv, abbott gmbh, wiesbaden, germany) and reactive results were confirmed with anti-hcv line-immunoassays (inno-lia hcv score, fujirebio europe, gent, belgium). based on lia positivity, in samples an association of hcv infection was supposed, because the residence places of donors were in three neighbouring villages situated less than km to each other. pcr was positive in samples. from these samples, hcv sequencing and phylogenetic analysis were performed. fourteen hcv infected samples of general population and of ivd users were also included into the study. results: phylogenetic analysis detected genetic relationship among the hcv virus sequences in donor samples. the most abundant was the a subtype, and it formed two different groups on the phylogenetic tree. according to their genetic distance, a more distant mutual ancestor could be supposed. two samples with b subtype originated from the same village, and their difference was only nucleotides. three hcv from the ivd user control group showed close genetic relationship with the viruses detected in the donor samples. summary/conclusions: based on our phylogenetic analysis, hcv transmission in blood donors could be the consequence of the ivd use and the origin might be related to or primary human sources. during and , a significant increase in the hcv seroprevalence among the ivd users was observed, which was approximately threefold in the rural areas of hungary. our recent findings highlight the importance of the proper donor selection, which can identify the typical signs of the ivd use. moreover, enhancing awareness of blood donors with education is a further significant issue in order to reduce the risk of transfusion transmitted infections. abstract withdrawn. background: in china, the residual risk of transfusion-transmitted hcv has been declining since screening of blood donors for anti-hcv and/or hcv nat from . however, many high sensitivity reagent, using to test blood donors' samples, lead to false-positive results and donors loss. aims: this study intended to establish a donor reentry procedure for hcv screening reactive donors in china. methods: from march to december , there were blood donor samples which were screened reactive or belonged to "grey zone" by elisa and/or reactive by nucleic acid test(nat) at the local blood centers were collected from chinese blood centers. all these samples were sent to institute of blood transfusion (ibt) national reference laboratory where anti-hcv and hcv individual nucleic acid test (id-nat) were conducted. if the results were reactive for anti-hcv, then the samples were tested with a recombinant immunoblot assay (riba). results: based on this study, of donors in the study who could be classified into two categories for hcv status: ( . %) true positive and ( . %) false positive. a total of of donors lost to follow-up, their hcv status cannot be determined with certainty. based on these data, a reentry procedure for hcv screening reactive donors was proposed. summary/conclusions: based on our proposed donor reentry procedure for hcv screening reactive donors, a majority of screening false-positive donors ( . %) can re-entry safely. abstract withdrawn. background: providing safe blood for transfusion in sub-saharan africa (ssa) is a particular challenge due to a combination of factors; limited resources and infrastructure, suboptimal diagnostics and a high prevalence of the major transfusion-transmissible infections (ttis). average seroprevalence data estimates from the ugandan and kenyan blood transfusion services (bts) for hepatitis c (hcv) currently stand at . % and . % respectively. between january and december , in mbale (eastern uganda) the hcv prevalence amongst blood donors was an alarming . %. with no provision or funds for confirmatory testing, the bts are unable to confirm or refute a diagnosis of active hcv. this results in large quantities of blood wastage, unnecessary anxiety in potential donors and high donor deferral rates limiting the donor pool. aims: we aim to determine the true prevalence of active hcv infection amongst seropositive donors in bts in uganda and kenya. in addition, we aim to compare the performance of locally used serodiagnostics and best available alternative tests and to examine the feasibility of cost-effective additional or alternative tests to help provide accurate results on the infectious status of blood. methods: hcv seropositive blood samples from bts study sites (kampala, mbale, mombasa) will be re-tested using the local serology screening test (abbott architect anti-hcv), an alternative who pre-qualified rapid antibody test (sd bioline) and a confirmatory test (hcv core antigen test). where there is discrepancy in the results or need for clarification, samples will be tested on the cepheid xpert platform by reverse-transcriptase pcr to obtain a quantitative rna result. s/co (specimen to cut-off) values for false positive samples (by screening serology) will be analysed and presented. pre-analytical factors (centrifugation speed, haemolysis check, time delay between collection and testing) will be controlled for and documented. results: pilot data from re-testing quarantined hcv seropositive donor blood (mbale bts) in uganda demonstrated that / seropositive blood ( %) was rna pcr negative. in december , / ( %) of seropositive samples (by screening anti-hcv serology) in kampala bts had s/co values between . - . ( . is the cut-off indicating a positive sample). data from the re-testing of seropositive samples as true representation of active hcv will be demonstrated and s/co values for the study period concomitantly with a retrospective analysis of january to december . preanalytical factors, cost analysis comparisons of the diagnostic platforms coupled with costs of the donor deferral process in false positive cases will be presented. summary/conclusions: for the bts in ssa there are significant resource and financial implications, as repeat testing and donor deferral counselling is required. evaluating and introducing new and appropriate diagnostics and algorithms in the screening of hcv is crucial in improving the supply of safe blood transfusion services in east africa. background: in november , the blood services of england, scotland and wales reduced donor deferral to three-months for commercial sex workers and individuals with higher risk sexual partners, including sex between men. the change was recommended after a detailed review by an external expert committee (sabto) which recommended that a shortened deferral of months would allow detection of recently acquired infection and maintain residual risk (rr) at a tolerable level. recommendations were accepted by government but with a government commitment to explore a more individualised approach. aims: to assess the impact of a -month deferral on blood safety in terms of epidemiology of infections in blood donors and compliance with donor selection criteria, and to explore evidence required to develop a more individualised approach to donor selection policy methods: routine uk blood donation surveillance data for - ( : preliminary) were reviewed. annual prevalence and incidence of hbv and hiv infection were estimated, with a poisson regression models to test for trends. incidence was calculated from donors seroconverting within -months, and/or microbiological and clinical evidence of recent infection. for donors positive in , compliance with the -month deferral was determined. uk hemovigilance data were scrutinised for evidence of transfusion transmitted infections (tti) associated with newly eligible donors. results: from to among new donors, annual hiv prevalence decreased significantly by an average of . % each year (p = . ) to . / , donations in ; no significant trend was observed for hbv. annual hiv incidence among repeat donors also decreased significantly by an average of . % each year (p = . ) to . / , -person years (pyrs) in (based on seroconverters). there was no significant trend in hbv incidence over the study period, however between and incidence increased from . / , pyrs to . / , /pyrs (based on and seroconverters respectively). with the information available to date, none of the seroconverting donors were non-compliant, and there was no reported confirmed ttis associated with the policy change. summary/conclusions: hiv prevalence and incidence has continued to decline. hbv incidence in repeat donors increased in although initial analysis suggests this is not associated with the policy change. monitoring continues, and residual risks will be re-estimated as data post-change accumulate. these data are reassuring, and therefore it is appropriate to scope the evidence for, and feasibility of, a more individualised approach to selection policy. a multidisciplinary steering group has been convened including representation from patient and stakeholder groups. gaps in knowledge are being defined, and a package of work is in development under the project of fair (for the assessment of individualised risk), using the abo rdf for guidance. background: permanent deferral of men who have sex with men (msm), established in the s, primarily to minimise the risk of hiv transfusion-transmitted infections is increasingly challenged. accordingly, blood services in many countries have changed to time-based deferral. in canada, a -year deferral was implemented in , reduced to -months in ; a -month deferral is now being considered. aims: to estimate the risk of undetected hiv among screened blood donations under a -month deferral since last sex between men. methods: the applied model combines features of previously published english and canadian models to estimate hiv risk under a -month deferral. three scenarios varying hiv incidence, prevalence and non-compliance under a -month deferral were modelled. assumed constants were the hiv nucleic acid window period, testing procedure error rate and assay sensitivity. model inputs were incidence under the current -month deferral, calculated as hiv positive donors with a previous negative within months divided by number of person years, numbers of hiv positive donations, hiv positive msm, hiv msm incident cases and newly eligible msm donors (from donor surveillance and compliance surveys). the risk with a -month deferral was estimated for three scenarios, one determined "most likely", where msm donor non-compliance, hiv incidence and hiv positive donations do not change and msm newly eligible to donate are estimated from compliance surveys. this scenario is based on data from two sequential policy changes in canada. an "optimistic" scenario where non-compliance halves and a "pessimistic" scenario where msm hiv incidence, hiv positive donations, non-compliance and new msm donors double were also used. the median hiv residual risk was used as the final estimate. the uncertainty in this estimate was assessed with the . th and . th percentiles over the simulation ( % ci). results: incidence, per , donations, was estimated to be . , . and . for the "most likely" "optimistic" and "pessimistic" scenarios, respectively. for the month deferral "most likely" scenario, hiv residual risk was predicted to be in . million donations ( % ci: in , million to in . million). for the "optimistic" scenario, hiv residual risk was estimated to be in . million donations ( % ci: in , million to in . million). finally, for the "pessimistic" scenario, hiv residual risk was estimated to be in . million donations ( % ci: in , million to in . million). with these residual risk estimates, based on the number of donations in canada, one hiv infectious donation would be in inventory every years for the "most likely" scenario, every years for the "optimistic" scenario and every years for the "pessimistic" scenario. summary/conclusions: the risks of hiv entering the blood supply in canada for a -month msm deferral are predicted to be very low for all modelled scenarios, including a "pessimistic" doubling of hiv incidence post change. background: safety of blood and blood products is a major concern in pakistan. the prevalence of transfusion transmitted infections among multi-transfused thalassaemia patients is high (above %). the hiv epidemic in pakistan is following the asian epidemic model where after establishment among the high risk groups, its transmission to general public is rapid. fear, stigma and ignorance have contributed heavily to hiv transmission in pakistan. the hiv detection among blood donors is on the rise and reports occur in media repeatedly. aims: to investigate the possible transmission of hiv through blood transfusion in punjab, pakistan and to highlight the steps being taken to reduce further transmission of infections methods: in september , a report of hiv transmission through blood transfusion was reported in the media where a mother and her newborn acquired hiv after blood transfusion from a hiv positive donor (confirmed later). the case was referred to and investigated by the punjab blood transfusion authority (pbta). the pbta team took blood samples of both recipients (mother and her newborn) and the blood donor who was a family relative. the samples were tested by highly sensitive chemiluminescence immunoassay (clia). the clia results confirmed the presence of hiv in both recipients and the blood donor. due to maternal hiv antibodies transfer through the placenta, the infection status of the newborn was not re-confirmed as he died within two weeks. the donor informed that he had donated times in the past few years. the pbta was able to trace only one earlier donation three months ago. the recipient (a female) was found, tested by clia and was found to be hiv positive. all these cases occurred in unlicensed private blood banks that were screening for hiv on rapid manual devices. the blood banks were sealed by the authority and infected cases were registered by the provincial aids control programme and are being treated. summary/conclusions: the main reasons for hiv spread through blood transfusion is the use of sub-standard rapid screening devices which are not evaluated and validated at a national level. in addition, the existing system relies on the family/replacement donors. the national safe blood transfusion programme, is implementing blood safety system reforms as recommended by who. under the reform agenda, the blood transfusion authorities have been made functional and grant licenses to only those blood banks with proper systems to ensure quality and safety of blood products. the programme is developing a national system for the evaluation, selection and validation of all assays used for screening of blood in close coordination with the drug regulatory authority of pakistan. to promote the culture of voluntary blood donations, the programme has taken concrete steps initiating with the formulation of a national blood donor policy, interaction with celebrities, celebration of world blood donor day and more recently the launch of blood donation feature through 'facebook'. the promotion of voluntary blood donation concept along with regulation of blood sector will reduce the risk of hiv transmission through blood transfusions in pakistan. mianyang blood center, mianyang urumqi blood center, urumqi, china rti international, rockville national heart, lung, and blood institute, bethesda stanford university, stanford, united states background: the incidence of hiv infections has increased substantially over the past decade in china, especially among young people, who represent nearly half of the chinese blood donor population. this upward trend in hiv infections underscores the importance of monitoring hiv prevalence and incidence in chinese blood donors. aims: to estimate hiv prevalence and incidence rate (ir) among chinese blood donors using blood donation data from five geographically-disperse blood centers in - participating in the recipient epidemiology and donor evaluation study-iii (reds-iii) china program. methods: western blot confirmatory testing was done on samples of blood donations reactive for hiv- / on one or both rounds of routine elisa tests or positive by nucleic acid amplification testing (nat). multiple imputation was used for samples with missing confirmatory test results. hiv prevalence was calculated among first-time donors. to estimate hiv ir in first-time donors, single-well lag-avidity eia testing was conducted with first-time hiv recent (incident) infections defined as being infected within approximately days based on avidity of hiv antibodies. a novel model was derived to estimate hiv ir among infrequent repeat donors who had provided only one donation in the - estimation interval. to derive an overall hiv ir for repeat donors, this estimate was combined with the classical-model ir estimated for repeat donors who had given at least donations in the estimation interval. multivariable logistic regression model was used to examine factors associated with hiv infection. results: a total of , , whole blood and apheresis platelet donations with postdonation screening results were collected at the five blood centers between and , including , donations from first-time donors and , donations from repeat donors. hiv prevalence among first-time donors was . per , donors ( % ci, . - . ). hiv ir was estimated to be . per , person-years ( % ci, . - . ) among first-time donors and . per , person-years ( % ci, . - . ) among repeat donors. hiv prevalence and ir varied across regions with an increasing trend observed at some blood centers. among first-time donors, being male, older than years, minority ethnicity, less than college education, and certain occupations (commercial services, factory workers, retired, unemployed, or self-employed) were associated with positive hiv confirmatory testing results. summary/conclusions: although hiv prevalence and incidence remain low among chinese blood donors, it is important to monitor hiv epidemiology in blood donors on a continuous basis, especially among populations and regions of higher risk. further donor screening and education strategies need to be developed and evaluated to reduce these risks. the ir methods used in this study for first time donors as well as repeat donors who donate very infrequently is readily applicable to other countries who have similar donation patterns. background: in thailand, the national blood centre is responsible for blood donation service which includes follow-up and blood donor counseling in order to indicate the infection status, especially hiv-positive blood donors. currently, although the epidemic of hiv infection in thailand is in decline, the hiv-positive cases still have been found in blood donors screening. thus, monitoring of hiv infection status in blood donors and post-blood donor counseling are important for providing the hiv-positive infected donors lead to access the hiv treatment immediately. aims: to study the hiv follow-up cases on serological testing over years for assessment of the hiv infection in thai blood donors. the retrospective analysis of hiv follow-up cases on serological testing (cmia, ics and western blot) was conducted during to at thai national blood centre. results: a total of , , voluntary blood donations over years, the repeated reactive results on hiv serological screening were , ( . %) cases and only half of these hiv reactive donors returned to follow-up testing for ascertaining their hiv status. for hiv follow-up process, the hiv reactive screening donors must be followed for months and tested by using the different three principles of hiv serological testing. a total of , hiv reactive results were separated to three patterns including hiv positive results, inconclusive results and negative results which the number of each group was , ( . %) cases, ( . %) cases and , ( . %) cases respectively. out of , hiv positive results, we found that , ( . %) cases were positive with all hiv serological testing for the first-time follow-up and ( . %) cases were tested and become to positive results after follow-up more than one time. in cases of inconclusive results, ( . %) cases were reactive only or testing(s) which these donors did not return to confirm again leading to temporarily deferred donors in blood donor system. in addition, ( . %) cases of inconclusive results could not conclude the hiv result although they were repeated several times. for the last pattern, , negative results cases showed ( . %) cases were negative results after follow-up over months while ( . %) cases were inconclusive results before changing to negative results which almost cases of this group were reentry as blood donor after deferral period is over. summary/conclusions: the number of repeated reactive results on hiv screening was constant over years of which returned to follow-up only half of hiv reactive donors leading to accumulation of temporarily deferred donors in blood donation system. hiv follow-up positive cases were informed and counseled immediately then referring to anonymous clinic for treatment. the problem and challenges of hiv follow-up were inconclusive results that were unclear and some of these did not return to retest lead to loss of re-entry donor who might be changed to negative result afterward. hence, the effective counseling and follow-up system need to be taken urgently to encourage the temporarily deferral donors returned to retest for reducing stigma of deferred donors in hiv follow-up cases. . we only analyzed the information that had non-reactive results for infectious markers reported by blood banks to sihevi-ins©, because they represent a risk for blood recipients. results: when loading the information of sivigila in sihevi-ins©, donors were found ( % men); of these people donations were obtained ( % whole blood). donors ( %) had a reactive result for hiv being subsequently reported in sivigila. in addition, five of them were reactive simultaneously for hbv in blood banks and took on average ae days to be reported in sivigila. donors ( . %) had an hiv reactive result notified by sivigila and subsequently they were reactive in blood banks. this behavior may suggest an attempt to spread the disease. donors ( % men) despite being initially reported in the sivigila database, presented a non-reactive result in a blood bank for hiv; one of them was reactive for syphilis and hbv and only one for hbv. this pattern may suggest false positive or negative results in one of the two databases analyzed. fourteen donors had negative test in blood banks for hiv and in a range of up to months they were reactive by sivigila ( % of them donate whole blood). this conduct may suggest that accepted donations were in a window period and therefore warrant further investigation. considering that two blood components could be obtained on average from each donor, a potential risk is estimated for recipients. summary/conclusions: the donors reported first in the blood banks through sihevi-ins© and later in sivigila allow to estimate an adequate orientation to the health services. the information from general epidemiological surveillance programs could improve the selection of donors and transfusion safety. background: it is assumed that bacterial contamination of blood products most often takes place during the donation process. the number of bacteria at this time point is estimated to be around - cfu per bag. little is known about the growth behavior of different bacteria species in whole blood (wb) units during storage and the distribution of bacteria to the different blood products. aims: aim of the current study was to determine the growth of different bacteria species in contaminated wb units and to study the distribution of the bacteria to the different blood components. methods: whole blood (n = - per species) was inoculated with approximately cfu of different bacteria species (escherichia coli, klebsiella pneumoniae, pseudomonas fluorescens, staphylococcus aureus, staphylococcus epidermidis, streptococcus dysgalactiae, streptococcus pyogenes) and stored for to h at room temperature before centrifugation and separation into red blood cells (rbc), buffy coat (bc) and plasma. bcs from spiked wb were each pooled with random bcs to prepare plasmareduced platelet concentrates (pc). samples were taken from wb after storage and from the blood products (rbc, bc, plasma and pc) right after preparation, and the bacterial titer was determined. sterility of pcs was tested by bact/alert after seven days of storage. results: bacterial growth in wb varied remarkably between donations and bacteria species. the highest titers in wb were detected for the streptococcus species, whereas staphylococcus aureus, staphylococcus epidermidis, escherichia coli and pseudomonas fluorescens did not multiply. bacteria preferably accumulated in the bcs during separation, reaching titers of up to . cfu/ml in bcs and up to . cfu/ml in the corresponding pcs right after preparation. in total, out of pcs tested positive for bacteria at the end of storage. the results were dependent on the species used: e.g., / pcs tested positive after spiking with streptococcus pyogenes, while only / pcs tested positive after spiking with escherichia coli. bacterial contamination of rbc and plasma units was much less frequent and associated with higher bacterial titers in the parental wb units. summary/conclusions: the growth and distribution of bacteria during processing of wb into the different blood products is species-dependent and remarkably varies between donations. results: both patients were male ( yo and yo) with a history of acute myelogenous leukemia status-post haploidentical stem cell transplant. the patients were thrombocytopenic and underwent simultaneous transfusion of irradiated, non-pr, day platelets stored in platelet additive solution, from a single apheresis collection. the blood supplier's primary pre-release bacterial cultures were negative, and the on-site point of release secondary safety measure pan genera detection (pgd) testing was negative for both gram positive (gp) and gram negative (gn) organisms. both apheresis units also passed visual inspection prior to release from the blood bank. during transfusion, both patients displayed signs of septic transfusion reaction including rigors, fever, hypoxemia, tachypnea, tachycardia, and hypotension. transfusion reaction evaluations were initiated, and both patients were admitted to the medical intensive care unit and started on broad-spectrum antibiotics. gram stain of one platelet unit demonstrated gram negative rods (gnr) and gram positive cocci (gpc) in clusters, and the second platelet unit demonstrated gnr only. repeat secondary safety measure pgd testing of both units was negative for both gp and gn organisms. direct bacterial cultures of both platelet units grew both gnr and gpc identified as a. baumanii and s. saprophyticus after h of incubation. colonies on the initial bacterial plates were too numerous to count (tntc), and subsequent re-plating of the platelet units showed: unit : a. baumanii tntc and s. saprophyticus with . cfu/ml unit : a. baumanii . cfu/ml and s. saprophyticus . cfu/ml blood cultures collected from both patients became positive within h with gnr on gram stain, and both blood cultures ultimately grew both a. baumanii and s. saprophyticus. the primary pre-release cultures at the blood supplier remained negative. after days on antibiotics and pressors, both patients stabilized and were discharged home. the blood donor was interviewed, and he was well. no cultures were collected. summary/conclusions: this case documents failure of both primary pre-release bacterial testing and secondary on-site point of release pgd testing to identify two pathogenic organisms. a. baumanii and s. saprophyticus are unusual causes of septic transfusion reactions, and it is possible that these organisms have different limits of detection in the pgd assay compared to other organisms. rapid attention to clinical signs during transfusion and prompt initiation of antibiotics is critical for the management of septic transfusion reactions. we are currently evaluating ways to further reduce septic transfusion reactions, including increasing the utilization of pathogen reduced platelets. background: transfusion-associated infections due to the transmission of bacteria still represents a major risk in developed countries nowadays. despite the refrigerated storage of red blood cells (rbc), fatal reactions of patients receiving contaminated rbc units are repeatedly reported. in order to further increase the safety of blood transfusions, new strategies and measures have to be developed. in this context, transfusion-relevant bacteria reference strains can serve as a valuable tool for the validation, comparison and interpretation of these new developments. aims: conducting a collaborative study to establish the first repository for red blood cell transfusion-relevant bacteria reference strains. methods: six bacterial strains (serratia liquefaciens, serratia marcescens, pseudomonas fluorescens, listeria monocytogenes, yersinia enterocolitica a- and yersinia enterocolitica a- ) were distributed from the paul-ehrlich-institut to laboratories in countries for enumeration, identification and growth measurement in a -day interval for a total of days after low-count spiking of rbc bags ( - colony-forming units (cfu)/rbc bag). results: except for s. marcescens, all other strains showed good-to-excellent growth in rbc. s. liquefaciens, p. fluorescens, y. enterocolitica a- and y. enterocolitica a- achieved > cfu/ml at day and cfu/ml at day . growth of l. monocytogenes was lower reaching a maximum concentration of > cfu/ml at day . in out of laboratories, s. marcescens showed no growth at all. summary/conclusions: five of the six tested strains showed robust growth in rbc independent of donor variability and are promising candidates to be adopted as official rbc transfusion-relevant reference strains by the world health organization. background: the samplok sampling kit (ssk), itl biomedical, is used by nhs blood and transplant (nhsbt) for sampling of platelet components (pc) for bacterial screening using the bact/alert d system. inoculation of bact/alert bottles is performed immediately after sampling. validation of delayed inoculation, with retention of the sample within the ssk devices, would allow a contingency for transport to other screening sites in the event of an incident that prevented testing at the sampling site. ssk maintain a closed system for sampling of pc and are compatible with standard blood collection bags. a graduated chamber ( or ml) ensures that only the required sample volume is collected and an integrated needle allows inoculation into bact/alert bottles. aims: the national bacteriology laboratory, nhsbt, evaluated the impact of prolonged storage of pc samples in ssk devices with regard to bacterial viability and detection. methods: four reference species were assessed: staphylococcus aureus (atcc ), streptococcus agalactiae (atcc ), escherichia coli (atcc ), clostridium perfringens (atcc ). a pool and split method was used with apheresis pc suspended in plasma. units were screened using bact/alert d prior to spiking to prove the absence of contamination. pc were spiked with a single species (range - . cfu/ml) and tested on bact/alert with a ml inoculation into anaerobic and aerobic bottles (positive control). enumeration was performed to confirm the bacterial concentration. each unit was sampled using two ml ssk, which were held for a period of h at - °c. the process was repeated with a -h period. once elapsed, ml of each ssk was inoculated into an aerobic and anaerobic bact/alert bottle, one ssk per atmosphere per species and the remaining sample was enumerated. all bottles were incubated on the bact/ alert system for a maximum of days ( ae . °c) and subcultured if positive. results: positive controls had detectable growth by bact/alert, excluding aerobic bottles with c. perfringens. this was expected as it is an anaerobic organism. after the storage periods, all bottles had detectable growth by bact/alert. s. aureus showed an increase of . -log after h ( . to . cfu/ml) and . -log after h ( . cfu/ml to . cfu/ml). s. agalactiae increased by . -log after h ( . cfu/ml to . cfu/ml) and . -log after h ( . cfu/ml to . cfu/ml). c perfringens increased by . -log after h ( . cfu/ml to . cfu/ml) and . -log after h ( . cfu/ml and . cfu/ml). for e. coli, the concentration after h was reduced by . -log ( . cfu/ml and . cfu/ml), however this was possibly a result of inherent counting errors. at h, an increase in growth by . -log ( . to . cfu/ml) was obtained. summary/conclusions: storage of pc samples in ssk devices for up to h does not have a negative effect on bacterial viability and detection using the bact/alert d system. background: the intercept tm blood system for platelets efficiently inactivates pathogens and leukocytes in platelet concentrates (pc). the system utilizes amotosalen and uva light and is available for the treatment of apheresis and whole blood (wb) derived platelets (mostly buffy coat pools) in europe in plasma or platelet additive solution (pas), and the treatment of apheresis platelets in the us (trima tm in % plasma or amicus tm for % intersol pas/ % plasma). acinetobacter baumanii and staphylococcus saprophyticus strains were isolated from a saline flush taken h after successful and complete transfusion of an apheresis intercept-treated pc in % pas/ % plasma, from a patient with a suspected septic reaction that occurred h post transfusion. bacterial isolates, and a sample of a gram stain-negative and culture-negative sister split pc were submitted for evaluation. we report here the in vitro inactivation of the fast growing, gram negative bacterium a. baumanii and slower growing gram positive s. saprophyticus. the sister unit was assessed for amotosalen break down products as an indication of successful inter-cept treatment. aims: the objective of the study was to evaluate bacterial inactivation of a. baumanii and s. saprophyticus in apheresis platelets, assessed immediately after treatment and with re-culture at the end of a day shelf-life. methods: a double apheresis pc collected in % pas/ % plasma was split into three equal components, yielding approximately ml of platelets/pc. a. baumanii and s. saprophyticus were grown in lb broth and each pc unit was inoculated with either bacterial strain or the combination of both strains, each at~ log colony forming units/ml (cfu/ml). after inoculation, the contaminated units were treated in small volume (sv) intercept kits. samples were taken: pre and post-inactivation treatment, and at , and days of storage. the samples were analyzed by plating on lb plates ( ll- ml). residual amotosalen levels were assessed by hplc. results: initial bacterial titers were . - . cfu/ml. following the inactivation treatment, no viable bacteria were detected by plate culture. no bacteria were detected after , and days of storage, corresponding to > . log inactivation of both bacterial strains. performance of the intercept treatment process was confirmed in the sister pc unit as evidenced by levels of amotosalen and its byproducts characteristic of intercept treatment, as well as by review of the process documentation. summary/conclusions: amotosalen/uva effectively inactivated a. baumanii and s. saprophyticus individually and together below the limit of detection after days storage. no bacteria in the sister pc by gram stain and culture, and the presence of amotosalen byproducts suggested that the pc collection involved in the septic reaction was sterile at the time of intercept treatment and was successfully illuminated. the possibility of only one-of-two split pc being contaminated due to biofilm formation is minimized in the intercept system which decants platelets into virgin storage bags at the end of treatment. contamination of the source pc container likely occurred after intercept treatment, possibly at the time of spiking for transfusion. background: studies in sub-saharan africa have documented bacterial contamination of blood products for transfusion varying between , %> , %, up to times higher than in the north. published data from central africa are lacking. aims: the aim of this study was to determine the proportion of blood products contaminated with bacteria in three hospitals in the democratic republic of the congo (drc). to assure aseptic sampling, we used a closed system of sampling bags. in addition to the presence of contamination, we assessed semi-quantitative colony counts. methods: from july to december , a total of blood products were sampled, of which in hôpital provincial g en eral de r ef erence, kinshasa (hpgrk), in hôpital p ediatrique kalembe lembe, kinshasa (hpkll) and in hôpital saint-luc, kisantu (hslk). after compatibilization of blood products, ml of blood was transferred from the primary blood bag to an attached sampling bag. sampling bags were sealed off, stored in the fridge and transported once daily to the bacteriology laboratory. using the adapter connected to the sampling bag, ml of blood was inoculated in a blood culture (bactalertpf, biom erieux) and incubated at °c for days. cultures were checked daily for signs of growth. in addition, ml of blood was equally distributed on the cled and macconkey agar-coated sides of a dipslide (meus s.r.l.). dipslides were incubated h for semi-quantitative culture, expressed as colony-formingunits (cfu) per ml. in case of blood culture growth, bacteria were identified and a second blood culture was inoculated to exclude contamination during processing. bacteria grown on semi-quantitative culture were also identified. results: a total of . % ( / ) of whole blood and red cell concentrates were contaminated with bacteria. in hpgrk, . % ( / ) of blood products were contaminated, in hpkll . % ( / ) and in hslk . % ( / ) . the proportion of contaminated blood products was significantly higher in hpgrk compared to hslk (p = . ). there was no significant difference between the other sites (p = . and p = . ). majority of isolated bacterial species were coagulase-negative staphylococcus spp./micrococcus spp. ( . %) and bacillus spp. ( . %). the remaining % of bacterial isolates were identified as non-fermentative gram-negative rods, klebsiella pneumoniae, staphylococcus aureus, mould, listeria spp., corynebacterium spp./coryneform bacteria. the concentration of all isolated bacteria was lower than ³ cfu/ml, except for one coagulase-negative staphylococcus spp. found in hpgrk at ³ cfu/ml. summary/conclusions: to our knowledge, we were the first to reach a sample size of more than blood products for bacterial culture and the first to use a closed system of sampling bags in sub-saharan africa, which guarantees aseptic sampling of blood cultures. this might explain the low bacterial contamination rate ( . %) of blood products in three hospitals in drc compared to previous studies in other sub-saharan african countries. moreover, bacterial concentrations in the contaminated blood products were low (< ³ cfu/ml). the different proportions of contamination between study sites suggest that different environments and practices play a role in the risk for bacterial contamination. background: although the screening of the treponema pallidum (tp) is mandatory in blood donations, its necessity is controversial, because there have been no transmissions by blood products documented in the developed countries in the last few decades. aims: based on laboratory markers, active and early tp infected donors (aeid) were determined. the demographics of aeid and the frequency measures of cases were compared with that of early infected syphilis cases (syc) notified from the to -year-old general population registered at the nphc. methods: altogether, , to -year-old donors were screened with anti-tp immunoassay (architect syphilis tp, abbott, wiesbaden, germany) between and . reactive results were confirmed with immunoblots (viramed biotech ag, planegg, germany), which discriminated both specific anti-tp (igg, igm) and non-specific vdrl antibodies in five dilutions. meeting the criteria of anti-tp igg positivity with a vdrl titer of ≥ : and anti-tp igm positivity, donors were considered as aeid. they were stratified by age, gender and residence regions. the proportion of aeid (paeid) and syc (psyc) were calculated in first time (ft), and repeat tested (rt) donors and in the to -year-old general population, respectively, in each year studied. the period prevalence (pp) of aeid and syc was estimated in the populations at risk , across - . statistics: weighted proportions and one-way anova with tukey post-hoc test and z score test were applied. statistical significance was defined as p < . . results: anti-tp reactivity was confirmed in blood donors. aeid was proved in cases with ft and rt donors. in that period, syc were notified. both in aeid and syc, the age group of - years with approximately % and % of individuals was the dominant. the proportion of men was % and % (p = . ) in the aeid and syc, respectively. paeid estimated in ft donors was significantly higher ( . %; . %; . %, p < . ) than that of rt donors ( . %; . %; . %) and the proportion of syc ( . %; . %; . %) in the general population. pp of aeid showed a roughly homogenous distribution in the regions ( . %- . %), however, pp of syc had a significant ( . %; p < . ) central hungary dominance in relation to the other regions ( . %- . %). comparing the pp of aeid to syc, central hungary indicated a significant difference ( . % vs. . %, p < . ), however, other regions showed no substantial differences. summary/conclusions: donors with anti-tp confirmed positivity are referred to the healthcare system. based on the laboratory markers tested, aeid could be separated and their demographical characteristics are pretty similar to that of syc notified from the general hungarian population. the proportion of early and active infection in ft donors is significantly higher than that of rt donors and the proportion of syc in the general population. given the considerable number of tp infection in background: quality assurance and safety of hematopoietic stem cells (hsc) with emphasis on prevention of bacterial and fungal contamination are the prerequisites for any transplantation procedure. bacterial contamination is of particular significance as it occurs relatively more frequently and bacteria are gradually gaining more antimicrobial resistance. aims: the aim was to determine the incidence rate of bacterial and fungal contamination during processing of transplantation material at the institute of hematology and transfusion medicine (ihtm) taking into account the hsc sourceperipheral blood (pbsc), bone marrow (bm) or cord blood (cb). methods: analysis involved both autologous and allogenic components collected at ihtm and other hospitals and dedicated for ihtm patients. in all, the analysis comprised donations, including bm ( . %), pbsc ( . %) and cb ( . %) donations processed in our laboratory in the years - . bm was collected in operating theatre-conditions, pbsc with cell separators -cs- (baxter), cobe spectra (gambro) and trima accel (terumo bct) and cb was acquired from umbilical vein at obstetrics and gynaecology wards. aerobic and anaerobic bacteria contamination was determined at various incubation temperatures (room temperature and °c) using a variety of culture media. pbsc and bm were tested using samples with trypcase-soy broth (tsb-t) and with schaedler + vit k (biomerieux). cb was tested using bactec peds plus/f and bactec lytic/ /anaerobic/f (becton-dickinson). results: in the - period contaminated products were found: pbsc ( . % of all tested pbsc units) and cb ( . % of all tested cb units). no infected bm products were determined. the overall percentage of contaminated products was estimated at , %. in , three ( ) products were found contaminated with staphylococcus epidermidis; all came from one patient with central venous catheter and were collected on consecutive days. other products were contaminated mostly with staphylococcus epidermidis ( . %). detailed results to be presented on the poster. summary/conclusions: according to ihtm policy no contaminated product is admitted to clinical use. the outcome of our study identifies processing experience of the staff as the main indicator of product quality. important is also proper assessment of donor health and condition of the injection site as products are usually collected from central venous catheter. the closed system is an additional safeguard against contamination during processing. the sample collecting procedure should help to avoid false positive results. background: syphilis is considered a global public health problem. the world health organization (who) estimates that there are annually around million new cases of syphilis in the world, more than % occurring in developing countries. despite significant decrease in syphilis transfusion transmission. the recent increase in worldwide incidence associated with the risk of transmission through platelet concentrates (cp), which are stored at room temperature, have called attention to the potential residual risk of syphilis transmission by transfusion. between and we observed in our institution a significant increase of % in positivity of syphilis among blood donors from . % in to . % in and . % in (p < . ). aims: to determine the prevalence of active syphilis in blood donors and characterize the serological profile of syphilis positive donors. methods: each positive sample in a treponemic chemiluminescence assay (cmia, abbott architect) performed during blood donor screening in was submitted to a treponemic elisa anti-treponema pallidum igm (euroimmun) and a non-treponemic test (antigen-omega diagnostics). samples with positive results for one or two of these tests (indicating recent syphilis) were submitted to a real-time pcr for syphilis. the inno-lia syphilis-fujirebio immunoblot test was also performed for samples that presented a positive result for elisa-igm alone. financial support: fapesp / - . results: among , samples screened in , ( . %) presented a positive result for cmia -syphilis. of these, ( . %) were included in the study. a total of samples ( %) showed vdrl+/igm+; ( %) vdrl+/igmand ( . %) vdrl -/elisa igm+. the inno-lia syphilis test was performed as a confirmatory test in ( . %) samples that presented positive results for elisa igm and vdrl negative with ( . %) positive results, ( . %) undetermined and ( . %) negative. none of the samples showed the presence of treponema dna by real-time pcr. the prevalence was . %, the incidence was . % in the year , and the incidence in relation to the total positivity was . %. both, prevalence and incidence were higher in men, white, not married, aging - years and high school educational level. we observed a % a-hbc seroprevalence in the elisa igm-syphilis positive samples and a prevalence of . % htlv coinfection. summary/conclusions: we observed a significant increase in prevalence of syphilis in ( . %) with an incidence of . % of the total of cases initially positive in the cmia test. according to our data, we could identify a risk of syphilis transfusion transmission in blood banks that exclusively use the vdrl for donor screening, once we found ( . %) cases with negative vdrl and elisa igm and inno-lia positive. continuous monitoring of the profile of donors infected with syphilis at this time of reemergence of the disease is useful and important not just for blood banks, as it reflects the epidemiological situation of disease in community, and can contribute to the definition of health policies. background: transfusion related sepsis is a serious concern limiting platelet storage time to days at room temperature. while most units are screened for bacterial contamination when collected, bacterial monitoring methods can take up to days to detect contamination. thus, cold storage of platelets represents an attractive alternative for improving platelet safety. in this study, we assessed bacterial growth in platelets stored either at room-temperature (rt; °c) or refrigerated (cs; °c). aims: the aims of this study were to ) assess the effect of storage temperature on platelet function and bacterial growth in "contaminated" platelet units, and ) identify factors contributing to bacterial growth during rt storage. methods: apheresis platelets in plasma (plt) were obtained from healthy donors using the terumo trima accel automated blood collection system (terumo bct). fresh plasma (fp) was collected similarly. aliquots of plt or fp were transferred to ph safe minibags (blood cell storage, inc) and "contaminated" with acinetobacter baumannii, escherichia coli, pseudomonas aeruginosa, staphylococcus aureus, staphylococcus epidermidis, or pbs (uninfected control). minibags stored at rt were agitated using an orbital shaker set to rpm while cs aliquots were stored under static conditions. bacterial growth was monitored daily through dilution plating. lactate levels were assessed by istat (abbott) cg + test cartridges. plasma glucose levels were assessed using blood glucose testing strips (germaine laboratories). platelet activation and aggregation were assessed on days , , , and by flow cytometry and multiplate platelet aggregometry, respectively. results: bacterial growth progressed rapidly over the first - days post-collection in all plt aliquots stored at rt except those challenged with s. epidermidis. significant growth of s. epidermidis was not detected until day . bacterial numbers remained unchanged in refrigerated aliquots through day . rt storage resulted in significantly (p < . ) decreased platelet aggregation over time which was exacerbated by bacterial challenge. plt function was largely preserved with refrigeration regardless of challenge. bacterial growth was significantly reduced, or at least delayed, in fp. fp challenged with gram-negative pathogens exhibited a significant (p < . ) delay in bacterial growth at day . while growth of e. coli and p. aeruginosa recovered by day , growth of a. baumannii was significantly (p < . ) inhibited throughout. fp challenged with gram-positive pathogens exhibited significant (p < . ) reduction in bacterial growth relative to plt aliquots. bacterial growth correlated with plt lactate production. lactate levels in plts challenged with e. coli showed diminished significantly after day , indicative of lactate utilization. with exception of fp challenged with s. aureus, bacterial growth was restored in fp supplemented with lactic acid in all challenge groups. summary/conclusions: refrigeration preserved platelet function while both inhibiting bacterial growth and lactate production. conversely, the opposite was observed with rt storage. these data demonstrate that bacterial growth can be controlled through refrigeration without loss of function and rt storage may potentiate growth of certain bacterial strains through accelerated plt metabolism. background: bacterial contamination of peripheral blood progenitor cell (pbpc) for transfusion has been the cause of serious sepsis and life-threatening infections. however, a standard procedure or choice of test sample(s) has not been established to screen pbpc products for microbial contamination, because these products are not large enough to facilitate inoculation of the recommended volume for the automated blood culture systems. samples taken from by-product plasma and low volume pbpc product were cultured in routine sterility test. aims: to evaluate the residual risk of microbial contamination in pbpc products for transplantation, we cultured sufficient post-thaw inoculation volumes from pbpc products which were discarded for various reasons in our blood center. methods: in routine sterility test, a -ml sample of by-product plasma collected with pbpc product was inoculated into bact/alert bpa and bpn culture bottle ( ml each) within h after collection. the bottles were then placed in the bact/ alert system and incubated for at least days or when a positive reaction was indicated by the automated liquid-media culture system. moreover, a -ml postthaw sample would be cultured before transplantation performed. in the residual risk investigation, discarded pbpc products were thawed, and then a -ml and a -ml aliquot were taken and cultured with the same method. all positive bottles were subcultured for bacterial isolation and identification. results: in september and march , after maintaining in liquid nitrogen for to years, pbpc products collected from patients, which was preserved in a volume between and ml, were discarded. all of these products had been cultured negative in routine sterility tests with plasma samples. these final products were thawed and cultured with both the -ml and the -ml aliquot. one of these pbpc products had the positive culture result with the -ml retested samples. nevertheless, the same pbpc product had the negative result with the -ml post-thaw pbpc sample and the -ml by-product plasma sample. propionibacterium acnes was isolated from the bpn positive bottle. summary/conclusions: the residual risk of microbial contamination in pbpc postthaw products still exist after routine sterility test with the plasma sample and the -ml volume of pbpc sample. the bacterium isolated from pbpc product was normal skin flora bacterium. an optimal screening method of pbpc products merits further study to increase the safety of the blood supply. background: hospital hygiene tools that serve as a proxy for assessment of microbial contamination are increasingly used. they include adenosine triphosphate (atp) bioluminescence and air particle counting. however, their use for microbial monitoring of blood banks remains underexplored. they could be of particular interest in a sub-saharan african setting (temperatures, dust) to circumvent bacterial culture and provide direct results usable for monitoring over time. aims: the aim of this study was (i) to quantify environmental bacteria in the air and on surfaces that are regularly in contact with blood products, and (ii) to evaluate atp bioluminescence techniques and particle counts as a predictor for bacterial contamination, in three blood banks in the democratic republic of the congo (drc). methods: samples were taken in three blood banks in the democratic republic of the congo: hôpital p ediatrique de kalembelembe (hpkll) ( surfaces, air), hôpital provincial g en eral de r ef erence (hpgrk) ( surfaces, air) and the national blood transfusion centre (cnts) ( surfaces, air). surfaces that are regularly in contact with blood products were selected (sealer, fridge, donor chair,. . ..). regular surfaces were sampled using rodac contact plates ( . cm²) containing cled and macconkey agar, irregular surfaces using swabs (nrsii, medicalwire). atp was measured on the same surface (pd , kikkoman), expressed as relative light units (rlu) per cm². air was sampled by active sampling ( liter; spinair, iul) on cled and macconkey medium. in parallel, particles > . lm and > lm were counted using a particle counter ( , liter; metone a). culture media were incubated for h at °c before counting colony forming units (cfu). results: for regular surfaces, the median (range) viable bacterial count was ( - ) cfu/rodac, ( - ) cfu/rodac, ( - ) cfu/rodac for hpkll, cnts and hpgrk, respectively. at hpkll, highest viable counts were found in the sink (plain growth) and cool boxes ( and cfu/rodac). in cnts the blood processing bench, the donor chair arm support and washing basin showed the highest counts (plain growth). whereas in hpgrk, most bacteria were found in a fridge (plain growth), blood bag trolley (plain growth) and manual separator ( cfu/ rodac). gram-negative bacilli were isolated from water basins and sink in cnts and hpkll, but also surfaces close to donor chairs at hpgrk. the median (range) of atp per cm² was . ( - . ) rlu at hpkll, ) rlu at cnts and . ( . - . ) at hpgrk. atp results and total viable count were not correlated (n = , p = . ). median (range) bacterial count in the air was ( - ) cfu/ l for all sites together. there was no correlation found between total bacterial count and particles > . lm or > lm (r = . and r = . respectively; p < . ; n = ) summary/conclusions: total viable bacterial count of surfaces varies over blood bank sites. according to our results, atp and particle counts did not correlate with bacterial counts on surfaces and in the air, respectively. bacterial isolates from blood bank environments in drc need to be identified and seasonal variations need to be evaluated. background: the risk of transfusion-transmitted hepatitis e virus (tt-hev) infections in line with the question of the necessity of hev-nat screening of blood products is currently subject to an ongoing debate on the importance of timely introduction of hev screening of blood donors and the impact of blood safety. different countries have chosen different regulatory approaches. just recently, the german federal authorities have introduced mandatory testing of all therapeutic blood products beginning from january st . however, we already decided to voluntarily test all our blood products since january . aims: in this study, we present our results of a % screening of therapeutic blood products for hev rna including four years of active surveillance of hepatitis e infection among blood donors in germany. methods: from january to december , a total of , allogenic blood donations from , individual german blood donors were screened in a minipool format of samples of for the presence of hev rna (realstar hev rt-pcr kit, altona diagnostic technologies (adt), hamburg, germany). nucleic acids were extracted from . ml plasma using the chemagen msm-i extractor (viral k, perkin elmer chemagen gmbh). the % lod of the assay was determined to . iu/ml ( iu/ml per single donation). the presence of hev-specific igm and igg antibodies was determined using the anti-hev igm/igg elisa (euroimmun, luebeck). hev rna concentrations were quantified using the first who international standard for hepatitis e virus rna for nat-based assays. all hev rna positive donors were deferred from donation for months. follow-up samples were tested for the presence of hev rna and hev-specific antibodies. genotyping was performed by sequencing of the hypervariable region (hvr) and orf . results: in total, hev rna positive donors were identified. of these, hev rna-positive donors, were nat-only positive donations ( . %, negative for anti-hev igm and anti-hev igg), three donors had a positive igm titer ( . %), donors showed reactive igm and igg titers ( . %), donors already had isolated igg titers ( . %). median values of viral loads were approximately twice as high in index donations that were antibody negative. merely donors showed elevated alt levels ( . %), mostly within a double increase within the reference range ( . %), only . % of donors had even further elevated alt levels. significantly higher alt values were found in donors with a viral load > , iu/ml compared to the group with viral loads between and iu/ml. available follow-up samples confirmed igg seroconversion for all donors, however we also observed long-term igm positivity in some donors. genotyping revealed genotype in all cases. the month-dependent incidence ranges from : to : , blood donations with a peak in june and july. summary/conclusions: the high number of identified hev rna positive donors emphasizes the need for hev-nat screening to increase the safety of blood products. this study further confirmed that hev infection is common in german blood donors. background: zika virus (zikv) is a mosquito-borne virus that has caused outbreaks in central and south america in february , and has threatened the safety of blood transfusion globally. there is a high risk of zikv transmission by whole blood and blood components transfusion. it was reported that, zikv rna in infected patients plasma can only be detected within to weeks. however, in whole blood, zikv rna might present positive up to day after the symptoms appear in some patients, even if the clinical symptoms disappeared with zikv rna negative in plasma. this phenomenon suggested that the presence of zika is associated with red blood cells (rbcs). moreover, another report showed that viral load in whole blood of type a west nile virus (wnv) patients was higher than type o, implying that the binding of virus to rbcs may be related to blood group glycoprotein. both of zikv and wnv are member of the flavivirus genus. the study is intended to explore whether zikv have the same adherence mechanism to rbcs as wnv. aims: to investigate the distribution of zikv in blood components and adherence of zikv to different blood types of rbcs in whole blood. methods: five units for each blood type of a, b, o and ab whole blood were randomly selected. each unit of ml whole blood was divided into two half-unit. zikv was added to one half-unit in a certain proportion, and incubated at °c for days. each component of whole blood was collected for viral load detection. in the other half-unit,rbcs were suspended in the same type pools of plasma with equal volume after the plasma removed from the whole blood after centrifugation. zikv was added with the same certain proportion, and then incubated at °c for days. the whole blood samples and the upper plasma by centrifugation were collected detected for zikv rna. meanwhile, rbcs were washed and resuspended with normal saline followed by viral load detection. results: zika rna of these samples which extracted from whole blood, rbcs, and plasma were determined in a quantitative reverse transcription pcr, and viral rna of each component was all up to copies/ml. although, zikv rna loads did not show significant difference in distribution between rbcs and their corresponding plasma components, zikv rna quantification were significantly higher than those in plasma (p < . ) in type o rbcs and lower than those in plasma (p < . ) in type ab rbcs. summary/conclusions: in our study, we detected high viral rna loads in rbcs. it was demonstrated that zikv adheres to erythrocyte in whole blood, and the blood type may have influence on the adherence. background: hong kong is not endemic for dengue virus (denv) with most of the documented cases being imported. the presence of sufficient number of mosquito vectors, aedes albopictus, in the territory has led to two self-limiting indigenous outbreaks affecting residents from to . during august to september , another outbreak of confirmed cases of autochthonous dengue fever were reported to the department of health, linked to two epidemiological clusters, one in lion rock park near wong tai sin (wts) district ( cases) and the other in cheung chau, an outlying island ( cases). aims: we assessed the risk of dengue transmission from blood donors during the outbreak using a simplified version of the probabilistic model developed by biggerstaff and petersen (b-p) and the european up-front risk assessment tool (eufrat) model (oei, transfusion, ) . methods: patient demographic and general population data were obtained from the centre for health protection and the department of census and statistics of the hong kong government for the number of -to -year-old patients in the outbreak and residents of the same age range in hong kong and wts district as at mid- respectively ( - years old being the eligible age range for first time donation). to apply the b-p model, we estimated denv incidence among donors in hong kong territory and in wts with confirmed denv infection during august to september after correction for clinical:subclinical infections ratio, the mean length of asymptomatic viraemia and the probability of collecting blood from asymptomatic donors as described previously (seed, transfusion, ). to estimate the risk using eufrat model, outbreak and blood donation variables were entered into eufrat's web-based interface (https://eufrattool.ecdc.europa.eu/), which provided automatic calculation of risk-related output parameters. results: while using the b-p model, the estimated risk of collecting a denv viraemic donation was one in , ( , - , , ) territory-wide for the -day study period but increased to one in , ( , - , ) in wts. similarly while applying the eufrat model, the risk of encountering a viraemic donor was in , ( , - , ) territory-wide and in , ( , - , ) in wts during the same period. the eufrat also predicted a territory-wide issue of . unit of denv-contaminated labile blood component during the outbreak period. summary/conclusions: like many mosquito-borne infections such as denv, the risk is characteristically localised and varies geographically and seasonally during outbreaks. the average predicted risk of collecting a denv-viraemic donation territory-wide is low at in , during the outbreak based on the b-p model, which was generally considered as tolerable. however, the risk increased by folds when blood donations were collected from wts residents, who had higher chances of paying visits to lion rock park in close proximity. it was then justifiable to institute risk mitigation policies such as geographically-based deferral and/or fresh component restriction, enhanced post-donation reporting, etc. to protect against blood safety. background: hev is a developing threat to blood safety following the reporting of several cases of transfusion transmission hev (tt-hev). transfusion-related hev infection has been reported in several countries but its true frequency is probably underestimated because it is often asymptomatic and testing of blood donors is infrequent. pakistan is classified as a highly endemic region; with sporadic cases of hev occurring throughout the year, mainly affecting the adult population. to the best of our knowledge, no studies have been reported from pakistan on the epidemiology of hev in blood donors. aims: to assess the epidemiology of the hev specific antibodies and serum alt levels in blood donors of capital twin cities of pakistan. methods: this cross sectional study was conducted from july to december at three blood banks in the capital twin cities (rawalpindi and islamabad) of pakistan. the blood donors were equally distributed across the three blood banks. only donors who tested negative for hiv, hbv and hcv were included in the study. serum alt levels were analyzed by using automated clinical chemistry analyzer (selctra pro m) using merck kits. all samples were tested for hev-specific antibodies (igm and igg) by using enzyme linked immunosorbent assay (elisa) kits (adaltis, italy). statistical analyses were performed using spss software version . (ibm). results: in our study population there were ( . %) males and ( . %) females. the mean age of recruited blood donors was . (sd ae . ), with a range of - . younger donors were more common with a frequency of - year olds of ( . %). we found an overall hev igg prevalence of . % and an hev igm prevalence of . %. there were ( . %) blood donors who were positive for both igg and igm antibodies. our results revealed that the hev specific antibodies (igg, igm) prevalence increased with age. the mean value of serum alt was . (sd ae . ) with a range of - iu/l. the serum alt levels were elevated (> iu/l) in ( . %) blood donors. there was significant correlation (p=< . ) between serum alt level and hev specific antibodies for igg and igm. summary/conclusions: this study shows that a significant proportion of blood donors at our blood centers have been infected with hev and may be able to cause tt-hev. as we have not yet measured hev rna, we have used igm antibodies as a proxy for donors who have active infection. hev is generally asymptomatic, so it is debatable whether mandatory hev screening in blood donors should be required. results of this pilot study show that there is a need to conduct a larger study at national level with highly sensitive assays before making screening for hev mandatory in pakistan. background: hepatitis e virus (hev) is a zoonotic virus. who estimates that there are million hev infections, million acute hev cases and thousands hevrelated deaths worldwide each year. in recent years, the prevalence of hev in european and american countries has increased significantly. the survey results show that the positive rate of hev igg in blood donors is respectively . % in new zealand, . % in britain, . % in denmark, % in the united states and . % in the netherlands. hev has become a global public health concern. in addition to the food route of infection, several cases have been reported that hev can be transmitted via blood products. aims: to investigate the prevalence of hepatitis e virus (hev) infection among voluntary blood donors and potential impact on blood safety in guangzhou china. methods: blood samples from blood donors were collected from april to april at the guangzhou blood center and were tested for anti-hev igg antibody (hev igg), anti-hev igm antibody (hev igm) and hev antigen (hev ag)by enzyme linked immunosorbent assay (elisa). hev rna detection was performed on hev antigen positive samples by rt-pcr. the association of age, gender, ethnicity, occupation and alt with hev igg and igm were analyzed by chi-square test. multivariate logistic regression analysis was applied to identify the independent risk factors of hev infection. results: the positive rates of hev igg, igm and hev ag were . % ( / ), . % ( / ) and . % ( / ), respectively. no positive hev rna was detected. age and ethnicity were independent risk factors for hev igg and hev igm. the rate of hev antibody increased significantly with age (igg or = . , p < . ; igm or = . , p < . ). donors who were zhuang minority ( . %, . %) showed higher anti-hev than those who were han ethnicity ( . %, . %), and the difference was statistically significant (igg or = . , p = . ; igm or = . , p < . ). in addition, we found that occupation was an independent risk factor for hev infection, where students showed the lowest anti-hev rate. summary/conclusions: the results indicate that the positive rate of hev antibody among blood donors in guangzhou is high, and the infection status differs in different populations. our study provides basic data for the estimation of risk of transfusion-transmitted hev. background: human cytomegalovirus (hcmv) belongs to the viral family of herpesviridae. it is an enveloped double-stranded dna virus, widely distributed in the human population ( - % seropositive subjects worldwide) and cause of severe disease in immunocompromised patients and upon infection of the foetus. in normally healthy subjects, hcmv persists lifelong without clinical manifestation undergoing alternating phases of active viral replication and latency. since hcmv can be readily detected in blood, as free virus as well as associated to neutrophils and monocytes, hcmv transmission is a complication of blood transfusion. even though leukoreduction of blood products has been shown to significantly reduce the risk of hcmv transmission, higher inactivation standards may be required for high-risk, immunocompromised groups of patients. aims: in this study, murine macrophages infected with murine cytomegalovirus (mcmv) were used as a model to study the inactivation cell-associated cmv in human plasma using the theraflex mb-plasma system (macopharma). methods: mcmv expressing the green fluorescent protein was used to infect murine macrophages. infected macrophages were harvested h after infection, washed and used for spiking of plasma. plasma units (n = , ml) were spiked with infected cell suspension ( % v/v) and treated with the theraflex mb-plasma system according to the manufacturer's protocol using the macotronic-b illumination device (macopharma). samples were taken after spiking (load and hold sample), after illumination with different light doses ( after addition of mb, , , and [standard] j/cm ) and after blueflex filtration. mcmv titers were determined by endpoint titration and large volume plating on murine fibroblasts. infectious virus, which expressed gfp in infected cells, was detected using a fluorescence microscope. results: the results of infectivity assay showed that the treatment of human plasma by the theraflex mb-plasma system inactivated cell-associated mcmv in a dosedependent manner. after spiking with mcmv infected macrophages a mcmv titer of . (bag no. ) and . (bag no. ) log tcid /ml was achieved in the plasma units. in hold samples, a mcmv titer of . (bag no. and bag no. ) log tcid /ml was determined. the illumination step of the theraflex mb-plasma treatment procedure efficiently inactivated mcmv. already three-fourths of the standard light dose decreased infectivity of cell associated and remaining cell-free mcmv to infectivity levels below the limit of detection (≥ . log). further investigations would be needed to evaluate the log reduction capacity of the blueflex filtration step for cell-associated mcmv. summary/conclusions: the results with the murine model virus suggest that the theraflex mb-plasma system is an effective technology to inactivate cell-associated cmv in human plasma units. background: the use of pathogen inactivation (pi) technologies for platelet concentrates and plasma is slowly but steadily increasing. methods for treatment of red blood cells (rbcs), the most commonly used blood component, are still under development. aims: a novel approach for pi in rbc units employing uvc light was developed. methods: pi treatment was applied to full-scale rbc units after leukodepletion. the pi capacity of the uvc-based method was evaluated by bacteria and virus infectivity assays. a panel of in vitro assays to measure quality, metabolism, functional, morphologic, and blood group serology variables was applied to a pool-and-split approach in which pathogen-reduced rbcs were investigated in comparison to untreated rbcs. results: uvc treatment caused dose-dependent inactivation of bacteria and enveloped and non-enveloped viruses in rbc units. at a full dose, the mean log reduction factors ranged from . (bacillus cereus) to . (serratia liquefaciens) for the tested bacteria, and from . (emcv) to ≥ . (vsv) for the tested viruses. uvc treatment did not alter rbc blood group antigen expression. quality of uvc-treated rbcs was maintained during storage, e.g. hemolysis in uvc-treated and untreated rbcs were well below . % until day of storage. summary/conclusions: the data obtained until now show that uvc irradiation is a potential new method for pi in rbcs and justify further development of this process. background: histo-blood abh antigens are the mayor allogeneic antigens in human and they are widely distributed in almost all tissues. the expression of a- , -fucosyltransferase (fuct ), encoded by fut gene, determines the secretor status of an individual. about % of caucasian population have a functional copy of fut (secretor gene) expressing abh blood group soluble antigens in organic fluids such as saliva and seminal plasma. this individuals are known as "secretors". soluble abh blood group antigens have been associated with several metabolic and infectious diseases as well as reproductive failures. the incidence of infertility related of both male and female factors continues to rise despite many advances in reproductive technologies. it is well known that abo antigens are expressed on sperm membrane and in seminal fluid of secretors as well as abo antibodies are present in cervical mucus. in previous studies we observed significant loss in progressive motility of spermatozoa of non-secretors compared to secretor ones caused by specific cervical mucus antibodies in abo-incompatible couples. in addition, sperm cells are haploid cells, so that a heterozygous individual has two sperm subpopulations, each expressing the corresponding allele. the specific antibody of cervical mucus will attack only its complementary sperm. aims: to evaluate the prevalence of secretor character in men belonging to fertile and infertile couples in order to investigate a possible association with reproductive success. methods: samples of semen, from infertile men and from fertile controls were studied. comprehensive infertility evaluation was performed in all patients according to who criteria. secretor phenotype was evaluated in seminal plasma by inhibition of hemagglutination assay using saline erythrocyte suspensions, monoclonal antibodies anti-a, anti-b and lectin from ulex europaeus (anti-h). to distinguish between abo genes, genomic dna was extracted by an enzymatic digestion method. pcr was designed with two sets of oligonucleotides that allow to amplificate two different regions of the transferases without use of restriction enzymes. by comparison of bands of the pcr products, the individual genotype was determine. cervical mucus antibodies of their female partners were titrated with the corresponding red blood cells. results: results were analysed in both groups. in infertile couples with abo incompatibility, the frequency of non-secretor phenotype of male partners ( . %) were significantly higher than those from fertile couples ( . %) (p < . ) the results obtained by pcr in sperm cells correlated % with red cells phenotypes. summary/conclusions: incidence of infertility continues to increase. several factors have a negative impact on men's reproductive health. immunological implications are now being studied and considered as a cause of failure in sperm-egg interaction, even among normal gametes. secretor phenotype in male partners could help reproductive success by blocking cervical abo antibodies. furthermore, if the male is heterozygous, cervical mucus antibodies will only affect the corresponding sperm. we propose to evaluate abh antigen expression on sperm membrane and seminal plasma as well as abo antibodies in cervical mucus to contribute to the diagnosis and treatment of human infertility. background: the h blood group contains one antigen, the h antigen, which is present on virtually all red blood cells (rbc) and is the acceptor substrate of both a and b gene-specified glycosyltransferases. in blood group o the h antigen remains unmodified and therefore its rbcs show the highest and the rbcs of blood type ab the least amounts of h antigen. individuals with the so called bombay phenotype carry homozygous h null alleles (h | h) and do not produce any h antigen. the para-bombay phenotype retains some h antigen on rbcs either induced by a weakly active (h+ w | h+ w ) or completely silenced fut gene (h | h), mandatory linked with an active fut gene. aims: in this study, we aimed to develop an adapted flow cytometric method to quantify the relative amount of h substance present on rbcs in order to distinguish different abo phenotypes in routine diagnostics as well as to capture rare h-deficient phenotypes. methods: analyses were performed on a flow cytometer (facs canto ii, bd biosciences, ch) and measured with identical instrument settings. list mode data were evaluated and visualised using bd facsdiva software. rbcs were incubated with increasing concentrations of monoclonal anti-h antibodies (bric -pe and a : mixture of bric -pe/bric , ibgrl, uk). after rinsing the cells with pbs, micro-aggregates were mechanically dissolved. rbcs from blood donors with different abo phenotypes (o ( ), a ( ), a ( ), b ( ), a b ( ), a b ( )) and patients with genetically confirmed bombay and para-bombay phenotype were assessed. results: saturation of h antigen binding sites on type o rbcs was achieved only upon use of a : antibody mixture (bric -pe/bric ) covering approx. half of the h-binding sites by unconjugated bric . in contrast, non-o type rbcs reached saturation of h-binding sites using pure bric -pe. rbcs coated with bric -pe at saturation revealed a distinct pattern of mfi (mean fluorescence intensity) depending on the abo phenotype. in addition, mfis of rbcs upon staining with bric -pe did discriminate bombay-and para-bombay type rbcs, respectively. summary/conclusions: adapted flow cytometry is able to distinguish variant expressions of rbcs h antigen. thus, our flow cytometric method may complement traditional serological and genetic analyses in routine abo phenotype cases or, more intriguing, when the bombay or para-bombay phenotype is suspected. it will be of interest to further prove this method by investigating additional rare h-deficient phenotype cases. s chen , , x xu , , x hong , , k ma , , j he , , j chen , and f zhu , blood centre of zhejiang province zhejiang provincial key laboratory of blood safety research, hangzhou, china background: weakened a and b antigen expression results in abo typing discrepancies. h gene controls the development of h substance from which a and b antigens develop. depressed a and b antigen expression and strengthened h antigen expression are always simultaneously observed in abo subgroups. there are other possibilities for weak antigen expression of abo system such as leukemic change and pregnancy. it is undiscovered whether abnormal expressions of a, b and h antigen stand for abo subgroups in hemopathic patients. aims: the aim of this study is to explore the role of enhanced reactions with anti-h in direction to abo subgroups of hemopathic patients. methods: samples from blood donors and hemopathic patients with nonconcordant abo typing by serological tests were collected after consent information. the agglutination strength of these rbcs with anti-h reagent was recorded. enhanced reactions were determined by comparison with the results from normal abo groups. the genomic dnas of samples were extracted and genotyped for abo system. this work was sponsored by the medical science research foundation of zhejiang province ( rc ). results: samples in blood donors showed increased expression of h antigen, of which were identified as abo subgroups. there were enhanced reactions in hemopathic patients. however, were finally confirmed as normal abo genotypes. no statistical significance ( . % vs . %, p > . ) in the frequency of strengthened h antigen expressions was observed between donors and hemopathic patients. the total number of subgroups is and respectively in blood donors and hemopathic patients. extremely significant statistical differences ( . % vs . %, p < . ) existed in the frequency of subgroups with enhanced h antigen, which meant the possibility of subgroups in hemopathic patients samples was less. summary/conclusions: the expression of h antigen is comparably enhanced in subgroups and hemopathies. but most of hemopathic patients with strengthened h antigen expression present normal abo genotypes. as a result, the enhanced reaction with anti-h is necessary but not sufficient for serological identification of abo subgroups in hemopathic patients. background: although the use of automated blood bank analyzer with the advantages of speed and efficiency has recently increased, the abo discrepancies in automated blood bank analyzer have caused the reporting delays of the results and increase of the task. aims: we analyzed the causes of abo discrepancies in automated blood bank analyzer and suggested a solution strategy based on the causes. methods: from november to january , cases ( . %) of abo discrepancies among , abo blood type tests performed using the -min reaction mode of ih- in chonbuk national university hospital blood bank were identified. we compared the test results of -min mode with results of immediate mode using different red cell reagents, and analyzed the causes of discrepancies by performing additional tests such as microscopy, auto-control, antibody screening and identification, anti-a and abo genotyping. results: in the immediate reaction using different red cell reagents, cases ( . %) of discrepancies disappeared and cases ( . %) remained discrepancies. all abo discrepancies observed in the -min reaction were due to serum side causes, and one case ( . %) was due to both of serum and red cells side cause. nonspecific response ( cases, . %), cold antibody ( cases, . %), rouleaux formation ( cases, . %), cis-ab ( cases, . %), and abo subtype ( case, . %) were analyzed as causes of discrepancies. one discrepancy due to cis-ab was disappeared in the immediate reaction using different red cell reagents, abo subtype was changed to totally different blood group, a. on the other hand, in cases of the discrepancy corrected by the immediate reaction using different red cell reagents, the intensity of the positive results still observed in immediate reaction was not different from the -min reaction. summary/conclusions: ih- , an automated blood bank analyzer, was considered useful for automation of abo blood typing, and some observable abo discrepancies are expected to be mostly addressed by reexamining with immediate reaction mode using different red cell reagents. abstract withdrawn. background: abo blood group antigens mainly expressed on red blood cells, but along with that they also present on many organs and tissues like epithelia, platelets, vascular endothelia and neurons etc. the importance of abo antigens extends beyond transfusion medicine by association with various systemic diseases like cardiovascular diseases, gastric diseases, cancers, infectious diseases etc has been proven previously. previous researchers also tried to find out the involvement of abo antigens in neurological diseases like alzheimer's disease, parkinson diseases etc. but association with neurological tumours is less explored. aims: this study aimed to analyse the association of abo blood group antigens with neurological tumours. methods: a retrospective study in a tertiary care institute in india analysed the years data from jan to dec . the carcinoma patient's admitted in neurosurgical department during study period were included in our study. their diagnosis and abo blood groups were collected from hospital information system. data were analysed into microsoft excel and spss (version ). results: during study period a total of patients with neurological tumours were admitted in our hospital. the blood group frequency of these patients were . %, . %, . %, . % for a, b, o and ab respectively. the common neurological tumours found in our study were glioma ( . %) followed by pituitary adenoma ( . %), meningioma ( . %), schwannoma ( . %), cavernoma ( . %), neuroma ( . %) and space occupying lesions ( . %). the prevalence of abo antigens was almost similar in all neurological tumours except in neuroma. neuroma was found in . % o group patients as compared to other blood groups which was found statistically significant (p < . ). summary/conclusions: in this study we tried to analyse the association of neurological tumours with abo blood groups antigens. we found there is no association of neurological tumours with abo blood groups because the prevalence on abo group in general population is almost similar in patient with neurological tumours except neuroma. neuroma group of tumours like neurofibroma, neuroblastoma, nerve tumours etc. were more common in o group of patients while in our population frequency of b blood group antigen ( . %) is more common as compared to o blood group( . %). background: rhd and rhce represent homologous genes in head-to-head position on chromosome (chr , p . ). they encode for the proteins rhd resp. rhce which compose together with rhesus associated glycoprotein (rhag), band and ankyrin the ankyrin complex (ac) linking the red blood cell (rbc) membrane to aspectrin of rbc cytoskeleton (s.e. lux, blood, ). cooperatively, the proteins of ac are important for maturation and physiologic properties of rbcs. many proteins of the rbc membrane express blood group antigens on their extracellular surface and are therefore of concern in transfusion medicine. cepellini et al. described weakened hemagglutination reactions of rhd+ rbcs in the presence of an rhc+ antigen (cepellini et al, pnas, ) . we attempted to further elucidate the expression of rhd/rhag proteins in various rhce/rhce pheno-/genotypes using a sophisticated flow cytometry approach. aims: in this study, we investigated a flow cytometric method for measurement of the antigen-density of various rhce-phenotypes. methods: analysis was performed on a flow cytometer (facscanto ii, becton dickinson (bd)) using bd facsdiva software and identical instrument settings for all samples. optimized number of rbcs was incubated with saturating concentration of pe-conjugated anti-rhd antibodies brad- /brad- /fog- (ibgrl, bristol, uk). debris was excluded by rbc gating in fsc/ssc plot. quantibrite-pe beats (bd) were applied according to manufacturer's instruction to quantify the relative expression of rhd epitopes. in addition a representative number of samples from common phenotypes were assessed for expression of rhag using bric- pe (ibgrl). results: a total of samples from healthy blood donors with serologically defined rhcde phenotypes were included into this study (rr( ), r r( ), r r ( ), r r( ), r r( ), r r ( ), r r ( )). variant expression of rhd by different rhce phenotypes using brad- -pe was shown. rhd was weakly expressed in presence of rhc antigen (cepellini effect). effect of rhd gene dose on rhd protein expression is mitigated by rhc/c genotypes. when only samples with molecularly confirmed phenotypes were assessed, the rhdce genotype predicts consistently the strength of rhd protein expression. outlier samples ( ) were retrospectively genotyped and revealed rhdce genotypes as expected from the strength of rhd expression falsifying serological rhcde phenotypes. in contrast, rhe/e polymorphic site does not correlate with rhd expression. in addition, rhag protein is equally present across all rhcde phenotypes. similar results were obtained by using alternative anti-d antibodies such as brad- -pe and fog- -pe, although different antibody's avidity precludes quantitative comparison of antigen expression on rbcs. summary/conclusions: sophisticated facs methods reveal different expression of rhd on rbcs according to rhce/rhce phenotype/genotype. rhc/c polymorphic sites (c. g>c, c. a>g, c. a>g of exon , exon resp. and intron ) are in linkage with rhd expression, confirming the observation by cepellini et al. in contrast, rhe/e (c. c>g, exon ) is not in linkage with rhd expression. based on epigenomic signature it is conceivable that altered transcription factor binding sites (tbs) of rhd mirrored by homologous rhc/c may cause variant rhd expression. rhe/e snp mirroring the homologous sequence of rhd in exon is not recognised as tbs. in addition, although ac comprises all three rh proteins (rhd, rhce, rhag), their transcriptional regulations seem to be distinct. red cell reference laboratory, australian red cross blood service, perth, australia background: the rh antigen was first described when an antisera thought to contain a potent anti-c did not react with all c+ cells. these non-reacting c+ cells were classified as c+, rh:- , and the antibody specificity anti-rh . most polyclonal anti-c contain anti-c and anti-rh . previous studies have shown of monoclonal anti-c reagents are actually anti-rh . these reagents will not detect the c antigen where the red cells are rh:- . aims: the australian red cross blood service investigated a phenotype discrepancy in a blood donor. the donor's historic phenotype c+ (r r) was inconsistent with the current donation phenotype c-(r r ). we aimed to investigate the cause of the discrepancy so the donor could be assigned the correct phenotype, identify the root cause of the discrepancy and implement any corrective actions. methods: the donor's red cells were phenotyped with all available anti-c reagents as per the manufacturers product insert across both manual and automated testing platforms. following variable results and weaker reactions with some reagents, dna was extracted from the edta sample and was genotyped using immucor bioarray tm hea precise and rhce beadchip tm . targeted dna sequencing of rhd and rhce was also performed using the trusight tm one sequencing panel. a review of the historical phenotype results, including the testing platform and reagents used at the time was also performed. results: on the current sample the donor's red cells gave a + reaction by tube with bio-rad seraclone â ( ) [clone ms ] and immulab epiclone tm [clone anti-c reagents. the sample tested negative on the beckman coulter pk using beckman coulter anti-c [clone ] blood grouping reagent and tested positive ( ) reaction on the immucor neo using immuclone â ( ) anti-c [clone . immucor bioarray tm hea precise beadchip tm predicted a c+ phenotype and no variants were detected with the bioarray tm rhce beadchip tm . the trusight tm one sequencing panel genotyped the donor as rhd* /* n. and rhce* . /* with a predicted phenotype of c+, c+ w , d+, e-, e+, rh: (locr+), rh:- . a review of the donor's historical records indicated the donor tested as c+ on the pk , which at the time was being used with an in-house bromelain preparation (sigma-aldrich) and diagast olymp pheno anti-c reagent [clone ms ]. summary/conclusions: results indicated the phenotype discrepancy was caused by the c+ rh:- variant associated with the rhce* . allele. reagents containing clones ms- and ms correctly phenotyped the donor as c+, with the manual tube reagents showing a weaker reaction which may alert the operator to a possible variant which is important in the patient setting. the beckman coulter pk and associated anti-c [clone ] failed to detect the c antigen. this reagent appears not to detect the c antigen where it is associated with the rh:- phenotype, which is in contrast to the previous report by faas et al, transfusion, where it was demonstrated that clone reacted with c+ rh:- bromelain treated red cells. abstract withdrawn. background: although serological rhd typing has always been challenging due to variation of techniques and variable sensitivity of anti-d reagents, most individuals are unequivocally typed as either rhd positive or rhd negative. however, variants of d (weak d and partial d phenotypes) may present typing difficulties. individuals with partial d (missing epitopes of the d antigen) must be typed as rhd negative as blood receivers, but as rhd positive, as blood donors. aims: the aim of our study was to evaluate the algorithm used since at ahepa university blood center, to resolve rhd typing problems among first time donors. methods: since automatic analyzers may type variants of rhd as rhd+, our practice is to routinely perform two different typing methods in first time donors: an automated microplate method on the neo analyzer (immucor) and the slide test, using a potent reagent (anti-d blend-immunodiagnostika). in case of negative, weak, slow or mixed-field reaction, further testing with an automated microplate weak d method [immucor-modified indirect antiglobulin (anti-igg) test] follows. the next step of the protocol consists of testing with the commercial id-partial rhd typing kit (bio-rad) comprising a panel of monoclonal anti-d reagents, in an indirect coombs gel test assay. the patterns obtained with this kit can distinguish between d weak and partial d and can also differentiate between categories ii, iv, v, vi, vii dfr, dbt and dhar. the last step of our algorithm consists of molecular testing (immucor bioarray rhce and rhd beadchip assays) at the hellenic national blood transfusion center, in case of remaining uncertainty. results: we applied the above algorithm in samples: a) by using the partial d kit, samples were typed: four samples were characterized as "partial d" ( dfr, diii) and as "weak d". four of the weak d samples (all from women of reproductive age) were confirmed by molecular typing ("weak d type " three samples, "weak d type . or . " one sample). b) the nine ( ) remaining samples that showed atypical serological pattern, were sent for molecular testing, which characterized samples as "weak d type ", one sample as "weak d type " and another as "weak d type ". results are pending for samples. summary/conclusions: in our experience some partial rhds may be mistyped as rhd+ if the technologist does not inspect the pattern of the reactions and only takes into account the assignment by the automatic analyzer as d+ or d-. by use of our algorithm, serological characterization was sufficient to distinguish between weak d and partial d in , % of cases. molecular typing was necessary in the rest. the integration of molecular techniques improves the quality and accuracy of d typing of blood donors. if applied to patients, it also allows administration of d positive blood without compromising safety to those carrying prevalent weak d types that have not been reported to produce anti-d. furthermore, it permits withholding rhig in case of pregnant women carrying such weak d types. background: rhd antigen is one of the most clinically significant blood group antigens. except d positive and d negative phenotypes, there are over rhd variants, which represent as serologic weak d phenotypes (swd). patients with certain swd can make anti-d alloantibodies. by serology testing it is not possible to clearly distinguish among different swd. in croatian institute of transfusion medicine (citm) patients and pregnant females with swd are mostly reported as rhd negative and generally did not refer for confirmation, because molecular testing was not part of the algorithm. that remains the risk of shortages of rhd negative blood and overuse of anti-d immunoprophylaxis for pregnant females. according to uk guidelines patients with swd who are likely to require chronic transfusion support and females ≤ years are treated as d negative and refer for confirmation of d type. people who are rhd genotyped as weak d type , or are not susceptible for rhd alloimmunisation. one study showed that in croatian population the most frequent variants are weak d type , and . aims: the aim of this study is to estimate the prevalence of swd in patients and pregnant females and to find out serologic and molecular characteristics of swd referred for confirmation. methods: from / / to / / we analysed . samples of patients and pregnant females. rhd typing was performed by anti-d igm monoclonal reagents in direct agglutination micromethod on tango (bs , bs ) (biorad, dreieich, germany), swing maestro [lmh / (ldm ) + - and th- + rum- + ldm ] and ih- [lmh / (ldm ) + - ] (id-card, biorad, cressier, switzerland). cut-off value for tango was determined as ++ and for gel microtyping as +++. the samples with results below the cut-off were reported and treated as rhd negative, all except those which gave discrepant results at current testing or with historical data. these were sent to rhd genotyping for confirmation. dna extraction was done by qiaamp blood mini kit (qiagen, hilden, germany) and rhd genotyping by pcr-ssp kits ready geneweak d and ready genecde (inno-train, kronberg im taunus, germany). results: from . samples ( , %) were swd. / ( %) were referred to rhd genotyping. / ( %) samples were weak d type , or , while / ( %) were weak d type and partial d variants vii and va. serologic reactions with monoclonal igm anti-d reagents showed different pattern for weak d types , and . clearly negative serologic reactions were given in / samples with bs and bs , in / samples with lmh / (ldm ) + - and in / samples with th- + rum- + ldm . summary/conclusions: the prevalence of swd in this study is rather low ( , %). after rhd genotyping % of referred samples were finally reported as d positive. serologic determination of d variants is inconsistent and only rhd genotyping can resolve rhd status in swd. to define the permanent rhd status of swd female of childbearing potential and patients who are likely to be chronically transfused we will introduce rhd genotyping in the new algorithm. background: among all blood group systems, the antigens of the abo system are by far the most clinically significant. comes second in importance is the antigens of the rh system, which comprise d, c, e, c, and e antigens. another clinically relevant antigen is the k of the kell blood group system, which is known to be involved in both htr and hdfn. the distribution of the major blood group antigens, such as rh, and kell, is well-studied among populations of developing countries. in contrary, a relatively few studies have addressed their frequencies in saudi arabian population this is also the case in jazan province, where only two published studies have analysed the prevalence of abo and d antigens, while the frequency of other clinically important antigens, such as rh and kell antigens, is yet to be explored. aims: to determine the frequency of the following clinically relevant blood group antigens; rh(d, c, e, c, e) and k among saudi blood donors in king fahd central hospital in jazan province. methods: a retrospective, cross-sectional study was carried out in the blood bank of king fahd central hospital in jazan province. the red cell phenotyping records for blood donation of randomly selected saudi donors, who donated blood between january and june , were reviewed to identify the prevalence for the following antigens: d, c, e, c, e and k. the hospital blood bank routinely performs rh/k phenotyping for all blood donation using either bio-rad or ortho diagnostic column agglutination technology (cat) platforms. phenotype frequencies were expressed as percentages. results: this study included a total of saudi voluntary as well as family replacement blood donors. the d antigen was found to be positive in . %, while k antigen was positive in . %. among other studied rh antigens, e was the most common ( . %) followed by c ( . %), c ( . %) and e( . %). dce/dce ( . %) and dce/dce ( . %) were the most common phenotypes amongst d-positive and dnegative donors, respectively. surprisingly, dce/dce phenotype was significantly prevalent ( . %) with almost times higher frequency compared that reported in caucasians ( . %). the rare phenotype dce/dce was found in donors ( . %), while dce/dce and dce/dce phenotypes were found in only one donor each. summary/conclusions: this study is the first to determine the frequency of rh and k antigens in saudi blood donors in jazan province. determination of the frequency of these clinically significant antigens in our geographical area will facilitate the selection of antigen-matched red cell units for transfusion in recipients with multiple alloantibodies. it will also help in the management of blood donation processes and planning the estimated need of blood stock of different blood group phenotypes to meet the patient's needs. abstract withdrawn. background: the gerbich (ge) blood group system includes several high-frequency antigens located on glycophorin c and d. with only few reports published on the clinical significance of antibodies directed against these antigens, it is unclear whether blood transfusions have to be antigen negative in the presence of an anti-ge antibody. the monocyte monolayer assay (mma) is an in-vitro method used to estimate the clinical significance of alloantibodies. aims: to illustrate the role of the monocyte monolayer assay (mma) in the transfusion management of a patient with an anti-ge alloantibody. methods: the clinical and transfusion history was retrospectively retrieved from the patient's medical records. serological investigations were performed by indirect antihuman globulin test. papain and trypsin treated cells were also used. the clinical significance of the antibody was assessed by mma. genomic dna was isolated from whole blood and the samples were further characterized by pcr. results: a -year-old male patient with lung cancer without previous transfusions was admitted ( / ) for surgery. his hemoglobin was . g/l. an anti-ge antibody was detected and it was decided to transfuse ge-positive packed red blood cells (prbcs). however, no blood transfusion was needed. in july , the patient was admitted for colon cancer surgery with a hemoglobin of , g/dl. the anti-ge alloantibody was still detectable and a ssp-pcr revealed the genotype ge* .- . an mma performed on the pre-transfusion sample revealed a monocyte index (mi) of . % and the antibody was considered not to be clinically relevant. the mi was interpreted as following: - % not significant; - % inconclusive; > % clinical significant. however, due to the clinical background of the patient it was decided to transfuse ge-negative prbcs, which were obtained from etablissement francais du sang (efs), paris, france. two days after surgery, the patient received units of ge:- ,- prbcs without any transfusion reaction. one and a half year later ( / ), peritoneal carcinomatosis, as a complication of colon cancer, was diagnosed. the patient's hemoglobin was g/l and he had a passage disorder, symptoms of deterioration and an adynamia. based on the mma results from july indicating no clinical significance of the antibody, it was decided to transfuse ge-positive prbcs. in the following days the patient received a total of units of gepositive prbcs no immediate or delayed transfusion reaction were observed following these transfusions. two further mma's, performed on samples drawn on december th and th ( days after transfusion of a total of three and two days after two further prbcs respectively), showed a mi of . % und % respectively and the anti-ge antibody was considered still not to be clinically significant. summary/conclusions: we report the case of a patient with an anti-ge antibody transfused with ge-positive prbc. as ge-negative prbc are not available in switzerland and not easy to obtain internationally the mma can help in the decision on how to transfuse. in this case, the clinical course confirmed the mma-based prediction. transfusions of ge-positive prbcs were tolerated without signs or symptoms of immediate or delayed transfusion reactions. background: abo grouping discrepancies occur when the results of forward grouping are not corroborative to those of the reverse grouping. these may be due to weak subgroups of a and b, missing or weak abo antibodies or red cell alloantibodies. determination of correct abo blood group of a donor is essential for preventing abo incompatible transfusions and to avoid hemolytic transfusion reactions in the recipient. aims: to determine the frequency of abo discrepancies and their resolution to correctly identify the blood group of the donors. we also determined the frequency of 'weak d' positivity in rhd negative donors. methods: this was a retrospective study on donor samples collected from st april, to th september, (two and a half years). for discrepant samples, the abo and rhd grouping was repeated using tube technique using commercial antisera {anti-a, anti-b, anti-ab and anti-d (igm), anti-d blend (igm+igg), anti-h and anti-a lectins}. adsorption-elution testing was done for detecting weak subgroups of a and b. antibody screen ( -cell) and identification ( -cell) was done by gel technique (bio-rad, switzerland). 'weak d' testing in rhd negative donors was also performed by gel technique. antibody titration was done using tube technique. the donor details including name, age and the registration/unit number of the donation were also checked for all the discrepancies to avoid repetition while data analysis. results: we detected ( . %) abo discrepancies out of the total donor samples tested during the study period. out of these, ( . %) were rhd positive. the most common cause of abo discrepancies was weak anti-b antibody ( / ; . %), followed by weak anti-a antibody and weak subgroups of a ( / each; . % each) and weak subgroups of b ( / ; . %). the remaining . % ( / ) discrepancies were due to agglutination with o cells in reverse grouping. the overall frequency of weak subgroups of a and b collectively was . % ( background: detection of unexpected red blood cell (rbc) antibodies before transfusion is critical for prevention of hemolytic transfusion reaction. ideally, unexpected rbc antibody detection is carried out within days after receiving a patient's sample. however, in some cases, retests could be performed after more than days for evaluation of any transfusion reaction, quality control or research. therefore, it is necessary to determine the stability of antibodies after refrigeration or freezing for a certain period of time. aims: we carried out antibody identification test with fresh, refrigerated and frozen samples using automated analyzer ih- and manual tube methods to evaluate the stability of antibodies after storage and compare the results between the two methods methods: antibody identification tests were performed using ih- (bio-rad, cressier fr, switzerland) and manual tube methods. fifty samples showing positive results in antibody screening test by both methods were divided into three and tested immediately, week after storage at °c and month after storage at À °c. the specificities and reactivities of antibodies at each storage state were recorded and compared between the two methods. results: specificities of antibodies identified were concordant between ih- and manual tube methods irrespective of the storage state. the results were as follows: anti-e/e+c, ; anti-le a , ; anti-di a , ; anti-c+e, ; anti-m, ; anti-d, ; anti-c, ; anti-k, ; anti-jk a , : anti-xg a , ; unidentified antibody, ; autoantibody, cases. with regard to the changes in reactivity owing to storage, ( %) samples (anti-e+c, ; anti-m, ; anti-di a , ; anti-d, ; anti-c+e, ; anti-le a , ; anti-c, : autoantibody, ; unidentified antibody, ) showed identical reactivities after week and month storage by both ih- and tube methods. however, ( %) samples, comprising unidentified antibodies, anti-le a , anti-c+e, anti-e, anti-e+c, and autoantibody, showed decreased reactivities after storage in both methods. three samples, comprising anti-di a , anti-e+c and anti-k antibodies, showed increased reactivities after storage. one sample with anti-jk a showed increased reactivity only after month storage, while one sample with anti-xg a showed decreased reactivity only after month storage. higher reactivities were observed in all samples detected using the ih- analyzer than manual tube methods (p < . , wilcoxon rank sum test). summary/conclusions: the specificities of unexpected antibodies detected by ih- and tube methods were the same in all storage states; however, reactivities were higher in ih- than in the tube method. twenty-six ( %) of samples showed identical reactivities after week refrigeration and month freezing. nineteen ( %) samples showed decreased reactivities after storage; however, ( / , %) of them were nonspecific antibodies, unable to identify using commercial id panels. therefore, it is suggested that retests for evaluation of transfusion reaction, quality control or research could be reliably performed after more than days, if stored appropriately in refrigerated or frozen states. abstract withdrawn. t gleich-nagel , d huber-marcantonio , n rufer , g canellini and c niederhauser unit of transfusion medicine, interregional blood transfusion src, lausanne laboratory diagnostics, interregional blood transfusion src, bern, switzerland background: a positive direct antiglobulin test (dat) is mainly found in patients with warm/cold autoantibodies or alloantibodies directed against transfused erythrocytes. the identification of antibodies fixed on red cells is important for the clinician, allowing the further evaluation of a patient's clinical situation including their current medication. in immunohematology the elution of a positive dat remains a tedious and expensive procedure. the blood transfusion service src (bts src) has derived a flow chart that indicates in which situation an elution of dat positive samples should be performed. in order to follow the bts src guidelines, it is mandatory to obtain additional data related to the patient's condition, such as haemolytic parameters and recent transfusion history. currently, our laboratory is not always able to apply the recommended flowchart, since information is often unavailable. aims: here, we performed a comparative study between the algorithm provided by bts src and our in-house strategy, which is based on the qualitative changes of a positive dat, without the need for additional patient and biological information. methods: details of dat positivity and the patient's transfusion history was taken from the software eprogesa (mak-system) and analysed in excel. we analysed a total of ' dats and evaluated them for their positivity, whether an elution was performed or whether antibodies were detectable in the eluate. furthermore, we performed an additional analysis on those samples, that were derived from recently transfused patients (< days). results: a positive dat was found for igg and c d in out of ' ( . %) samples, a level similar to previous reports of positive dats for hospitalized patients. among these positive samples, ( %) were eluted because of a qualitative change in their positivity according to our in-house algorithm. identification of warm autoantibodies or alloantibodies occurred in only . % ( / ) of the cases. from the patients transfused within the last days and having a positive dat, ( %) were eluted according to our in-house algorithm. the same samples would have been analysed if the swiss transfusion guidelines had been applied. however, this comparative study reveals a significant discrepancy in regards to overall sample numbers that should have been eluted according to the two algorithms ( versus samples). this is mainly due to the fact that the swiss transfusion based algorithm does not recommend an elution of positive dats from patients who did not receive a transfusion within the last -days, except if there is a significant clinical suspicion (e.g. haemolysis). summary/conclusions: this comparative study indicates that our elution-based algorithm was performed on all clinically relevant samples as recommended by the bts src guidelines. qualitative changes in the dat positivity represent our main parameter for selecting those samples to eluate. besides ensuring that no clinically relevant samples were missed, this strategy also led to a large number of unnecessary elution analyses. in conclusion, a significant reduction in the laboratory workload and economical savings arises if the relevant clinical information and patients history is known prior to laboratory analysis. background: novel anti-cd monoclonal antibodies, such as daratumumab (dara) and isatuximab, used in treatment of multiple myeloma, interfere with routine blood bank serologic tests. as part of the strategies to manage these patients, it is recommended to perform extended phenotyping to provide matched units (aabb association bulletin # - ). many investigations have focused on the interference with iat for the screening and identification of underlying alloantibodies and how to overcome them, but less has been published on the potential interference with extended phenotyping techniques. aims: the purpose of this study is to compare different technologies to type the most important antigens in myeloma patients before and during the treatment with therapeutic anti-cd antibodies. vox sanguinis ( ) (suppl. ), - methods: edta-anticoagulated whole blood samples coming from patients in different stages of treatment with daratumumab and with isatuximab have been typed in parallel with dg gel microcolumn (grifols) and mdmulticard technology (grifols). the results are also compared with genotyping results obtained with id core xt (grifols). direct coombs, autocontrol and antibody screening has also been performed as complementary tests. results: the study provides that four patients had positive dat and/or ac before therapeutic cd antibodies treatment. in these cases, of negative antigens (fy / jk and/or s) turn to positive in gel technology but mdmulticard showed % agreement with genotype id core xt results. focusing in the data obtained during the treatment, negative antigens were type as positive in gel technology ( % of the tests). mdmulticard agreed with genotype in % of the analyzed antigens. as complementary data, of patient-treated samples had dat or ac positive and showed panagglutination. summary/conclusions: the results demonstrated that mdmulticard is an effective method to type cd -directed cytolytic antibodies treated samples in addition to dat and or autocontrol positive samples. background: antibody titration is a semi-quantitative method to estimate the strength and concentration of antibodies present in plasma or serum sample. titration methodology should be validated together with clinical data to evaluate the relevance of the titer value in each application. the titer of an antibody depends on different parameters: the antibody concentration in the sample, the density of the corresponding antigen expressed on the red blood cells used, the affinity constant of the antibody-antigen and other parameters regarding the technique used (e.g. gel cards or tube test). gel cards technology reduces the intra and inter-laboratory variation in titration studies comparing with the tube technique. aims: to evaluate the suitability of dg gel coombs, dg gel anti-igg and dg gel neutral (grifols) for titrations using two sample volumes ll and ll. methods: twenty frozen plasma samples containing unexpected antibodies from different specificities (anti-jk a , -fy a , -k, -d, -e and -c) were titrated in dg gel coombs and dg gel anti-igg cards and donor fresh plasmas with natural occurring antibodies (anti-a and -b) were titrated in dg gel coombs and dg gel neutral (saline technique). the titer of the antibodies was determined by testing two-fold dilutions of the plasma with selected red blood cells depending on the antibody tested. plasma samples were diluted in dg gel sol. selected red blood cells serascan diana, serigrup diana or donor blood were added into the card ( ll at . %). further, sample dilutions were dispensed into the card ( ll or ll). subsequently, cards were incubated min, °c (coombs technique) and min, - °c (saline technique), centrifuged in dg spin and the results read. agglutination intensity was graded visually according to the instructions for use of dg gel cards. the reciprocal of the highest plasma dilution that gives macroscopic agglutination was interpreted as the titer. results: titers obtained with dg gel coombs and anti-igg (n = titrations, titer ranged - ) were compared for each sample with unexpected antibodies. no differences were found between gel cards types (differences were ≤ . titer in the % of the cases). differences between dg gel coombs and neutral (saline technique) (n = titrations, titer ranged - ) were observed when anti-a and -b antibodies were titrated using the same sample. the titer was similar or higher in coombs in comparison to the saline technique. coombs titers may be a mix of igm antibodies reacting at °c and igg antibodies. differences were > titer in % of the comparisons and ≤ titer in the rest of the cases ( %). comparing sample volumes of ll and ll in all cards (n = titrations), higher titers were observed using ll, as expected. differences were titer in the % of the comparisons, < titer in % and > titer in the % of the cases. background: autoimmune haemolytic anemias (aiha) are characterized by production of antibodies directed against red blood cells and destruction by the mononuclear phagocytic system or complement system. aiha observed in paediatrics is usually self-limiting and often precipitated by viral infections. in some, the condition is secondary to autoimmune diseases, drugs, infections or underlying primary immune deficiencies. appropriate immuno hematological evaluation to characterise the underlying autoantibody can help identify the type of aiha to aid in diagnosis & treatment of these cases. aims: retrospective analysis of immune-hematological evaluation, treatment and outcome of aiha in paediatrics. methods: patients aged - years, diagnosed with aiha, between april -december ( months) were included in this analysis. aiha was defined as positive direct coombs' test (dct) with anemia associated with corroborative evidence of haemolysis in the form of raised indirect hyperbilirubinemia, raised ldh, raised reticulocyte counts or red cell agglutination on peripheral smear. further monospecific dct and evaluation for the specificity of autoantibody was done for all patients using biorad gel cards and panel cells. steroids were given as first line in all; second line agents included cyclosporine and rituximab. red cell transfusion was given in those with severe anemia with cardiac decompensation. results: patients were diagnosed during the study period with autoimmune haemolytic anemia. haemoglobin at presentation ranged from . to grams/dl. the initial presentation was severe anemia in children and mild-moderate anemia with thrombocytopenia (evan's syndrome) in . the trigger for haemolysis was infection in children. rheumatological evaluation was performed for children out of whom were diagnosed as evolving lupus. primary immune deficiency evaluation was advised for and one child was diagnosed as suffering from combined immunodeficiency. dat was positive in out of aiha patients as one of the infant had dat negative iga mediated aiha secondary to viral infection. two out of dat positive cases had igg & c d positivity on monoclonal dat testing whereas rest had only igg coating the red cells. dat titration was more than : in patients; where only of these patients had both igg and igg coating and rest had only igg . alloantibody screen was negative in all. specificity of autoantibody was found only in one case, which was against rh blood group antigen (anti e). all patients received prednisolone as the primary treatment. three children attained remission following a - weeks of steroids. in those who were steroid dependent, cyclosporine was used as the second line agent in and rituximab was used in . out of these children children are in sustained remission and off any medication, whereas the rest are on low dose steroids with cyclosporine. summary/conclusions: aiha is not an uncommon problem in children and can vary in its clinical severity. the proper diagnosis and management involves efficient immuno-hematological evaluation, as detailed characterization of the autoantibody coating the red cell is very important in guiding the clinician for management and prognosis. abstract withdrawn. background: drug-induced immune hemolytic anemia (diiha) is rare and has only been described once with dexchlorpheniramine (polaramine tm), an antihistaminic agent widely used in the treatment of a variety of allergic reactions. we report a case of diiha complicated with acute renal failure associated with antibodies to dexchlorpheniramine. a -year-old woman with no history of transfusion, was treated semimonthly with a combination of chemotherapy and targeted therapy for metastatic colorectal adenocarcinoma. her chemotherapy regimen consisted of oxaliplatin and -fu with leucovorin rescue (folfox). panitumumab (monoclonal antibody anti-egfr) was used as targeted therapy. premedication with dexchlorpheniramine iv was systematically given at the beginning of each cycle of treatment to reduce the risk of perfusion reactions mainly associated with panitumumab. the patient developed chills and febrile agranulocytosis during the first and second infusion respectively. the third infusion was not performed due to pyrexia, chills, general discomfort experienced by the patient at the beginning of chemotherapy. probabilistic antibiotherapy was administered and the patient recovered rapidly. during the next infusion (day ), following premedication with dexchlorpheniramine, a more "impressive" reaction including all the above mentioned symptoms occured along with back pain and dark colored urine. the infusion was halted and no chemotherapy was delivered. bacterial infection at the implantable port was first thought to be the cause of this adverse event but was not confirmed. additional laboratory findings revealed biological signs of inflammation associated with iha and acute renal failure. the patient was treated with hemodialysis (day ), two units of rbcs (day ) and was discharged one week later in stable condition. dexchlorpheniramine was then suspected and samples collected on day were sent for a diiha laboratory workup. aims: the aim of this study was to support a clinical diagnosis of diiha. methods: laboratory workup included direct and indirect antiglobulin tests (dat and iat). drug antibodies investigation was performed by incubating patient's serum and eluate from patient's rbcs in the presence of drug against normal donor rbcs that had not been previously treated with the drug (i.e., by the so-called "immune complex" method). control tests were performed in parallel. drug was diluted in pbs and tested at and mg/ml. results: dat was positive (anti-igg + , anti-c d + ) and no unexpected rbcs antibodies were detected by iat in patient's serum and eluate without the in vitro addition of the drug. an antibody directed against untreated (titer ) and enzymetreated (titer ) normal donor rbcs was demonstrated only in patient's serum in the presence of the drug tested at mg/ml by the gel method. the pool of normal sera did not react in the presence of the drug. summary/conclusions: the multi-drug treated patient described in this study was demonstrated to have dexchlorpheniramine dependent antibody detected by the "immune complex" method. the key to the diagnosis was the observation of positive dat with negative eluate tests which prompted a reexamination of the medications administered in temporal relationship with the hemolytic event. although rare, this case report should alert physicians to the need to investigate the possibility of dexchlorpheniramine induced hemolytic anemia in any patient who develop unexpected anemia after hematologic or oncologic procedures p- singapore, singapore, singapore background: daratumumab is a monoclonal antibody against cd used in the treatment of multiple myeloma and has been known to bind to cd on rbc's and interfere with indirect antiglobulin based serologic tests such as red cell antibody screens and crossmatch compatibility testing. in order to negate the interference of daratumumab, our reference laboratory follows the daratumumab protocol recommended by the aabb which uses dithiothreitol (dtt) treated reagent red cells in red cell antibody screening and identification test in patients known to have received daratumumab. aims: the objective of this study is to determine the impact of daratumumab in the turnaround time (tat) for red cell antibody screening and identification. methods: a retrospective review of the tat for red cell antibody screening and identification samples of patients known to be treated with daratumumab from october to december was performed. turnaround time is defined as the time the sample is received up the time the results were reported. the tat for routine red cell antibody screen and identifications were also reviewed during the same period and was compared with the tat of samples from patients treated with daratumumab. results: a total of patients on daratumumab had samples sent to our reference laboratory for red cell antibody screen and identification during the study period. information on daratumumab treatment was not provided to the reference lab prior to the start of testing in of the patients while the use daratumumab was mentioned in the serology request form of the other patients. the median tat for red cell antibody screen and identification is min (range: - ) if information on daratumumab was provided prior to start of testing and min (range: - ) if information was not provided prior to testing. the median tat for routine testing is min (range: - ). using wilcoxon rank-sum test, turn-around time for antibody screening and identification for daratumumab treated patients was observed as statistically not significant when compared to routine samples (p value . ). however, tat for serologic tests requests with appropriate medical history compared to the testing requests without relevant information was also observed to be significantly difference (p value . ). summary/conclusions: there is no significant impact in the tat of red cell antibody screen and identification in patients known to receive daratumumab as compared to routine testing. however, there is a significant difference in the tat if information on daratumumab treatment is not provided prior to testing. this highlights the importance of providing the relevant medication information in the request form in order to prevent delays in testing and provision of blood to patients on daratumumab, which can result in improved organizational efficiency and have positive impact on cost and resource savings. background: daratumumab, an anti-cd monoclonal antibody, has been shown to be highly efficacious in the treatment of multiple myeloma (mm). cd is a glycoprotein highly expressed on plasma cells and, to a less extend, on the surface of red blood cells (rbc). when bound to cd on rbc, daratumumab interferes with the pretransfusion tests, with positive antibody screening and crossmatch. anti-cd interference is an important challenge as many mm patients will require blood transfusions during their treatment. dithiothreitol is a reducing reagent with multiple applications in blood bank testing. treatment of rbc with dithiothreitol irreversibly removes cell surface cd tertiary structure, avoiding the binding and testing interference by the anti-cd daratumumab. aims: to demonstrate the efficacy, safety and celerity of the protocol between the blood bank (bb) and haemato-oncology of our institutions, using just the crossmatch. methods: a retrospective research was used for the evaluation of the results obtained from the implemented protocol. this comprehends a previous contact by haemato-oncology that leads to a study of the patient before the beginning of daratumumab treatment, and consists in: abo/rhd grouping; rh and kell phenotyping, and other clinically significant antigens; antibody screening; and direct antiglobulin test. genotyping may be required for some patients who received previous blood transfusions. before the beginning of the therapy, a blood sample of the patient is sent to the bb to perform laboratory tests and frozen after. this frozen sample is used for crossmatching in patients that already started therapy, did not have a blood transfusion in between, and have a positive antibody screening and/or crossmatch. in further transfusions, in case of positive tests, the dithiothreitol-treated donor rbc is applied. the donor rbc antigens are always selected accordingly to patients negative clinically significant antigens, when transfusional support is needed. the laboratory tests are executed in gel column agglutination technique. results: since , patients were studied, from which were transfused with blood units, according to the protocol. there were no immunizations or adverse reactions to transfusion registered within the transfused patients, neither delay on the availability of blood units. patient blood sample collected and frozen prior to the beginning of the treatment, has shown to be a good strategy by reducing significantly the waiting time for the blood unit in the first transfusion. summary/conclusions: this protocol, which defines the communication among the involved professionals, has shown to be a secure and effective way of reducing interferences caused by daratumumab. it ensures the previous study of the patients and their transfusion with rbc respecting the patients negative clinically significant antigens. if not adopted, the mitigation measures described in this protocol, delays in the availability of the rbc requested and alloimmunizations, may and will possibly occur. a good communication between the bb and the haemato-oncology is crucial for a good time management when a transfusion is requested for these patients. three methods were used to resolve this dara interference. reagent rbc's were treated with dtt, which know to denature cd and then tested with patient plasma. allo-adsorption study was performed using a certain ratio of red cells to plasma. in addition, a selection of phenotyped cord cells were used as an antibody screening panel. results: dtt treatment of reagent red cells was successful at eliminating dara interference and allowing for the presence of underlying antibodies to be identified. in this case, underlying antibodies were not detected by using reagent dtt treated red cells or phenotyped cord cells. adsorption technique was ineffective at elimination the reactivity. summary/conclusions: dara is the first commercial fda-approved therapeutic monoclonal antibody used in treating multiple myeloma patients. • since cd is weakly expressed on normal red blood cells, dara attachment to red blood cells can interfere with pre-transfusion iat testing. • dtt treatment of reagent red blood cells and cord cells can abolish the interference of dara to test for the presence of underlying alloantibodies. • to prevent delays in issuing red blood cell units to patients, hospitals should send patient samples to be tested before receiving dara treatment to ensure that clinically significant alloantibodies are not being masked. background: antibody screening (as)is considered superior to antihuman globulin (ahg) cross match during pretransfusion compatibility testing. in spite of knowing the utility and superiority of as, it has not been adopted uniformly in india. therefore, scarce data is available from this subcontinent in terms of optimisation of red cell antibody detection during pretransfusion testing in form of "type and screen" aims: the main objective was to study the benefits of performing simultaneous antibody screening along with the blood grouping during the first hospital visit to the hospital. other objectives were to study the prevalence of clinically significant antibody among the indian population and to follow up the patients who were transfused antibody screen negative but cross match incompatible blood. we also studied some other relevant quality indicators related to efficiency of blood transfusion services methods: this prospective study was carried out at a tertiary healthcare centre in india between july and dec ( months). the study protocol was submitted to institutional review board and permission was granted. blood grouping and as were done during patients' first hospital visit, which we called "type and screen". when the patient got admitted to the hospital and required blood transfusion, a blood request form was generated by the user and sent to blood bank. depending upon the results of antibody detection, further course of action was chosen. if patient was found to have no antibody, immediate spin test (ist) cross match compatible blood was issued and transfused. in such cases the procedure of ahg crossmatch testing was continued even after issue of blood. cases where ahg cross match test was found negative no further follow-up of the patient was done whereas when ahg cross match was found positive, patients were followed after the transfusion results: a total of patients were "type and screened". majority were from hemato-oncology, bmt, liver transplant, paediatric cardiac surgery, and medical icu units. clinically significant allo-antibody was detected in patients and autoantibody was detected in patients. alloantibody was detected mainly against rh and kell blood group systems. in diagnosed aiha cases, majority were in the form of warm aiha ( %) and % of aiha cases were having hidden single or multiple alloantibody. significantly higher proportion of patients in as positive group required blood transfusion than as negative group ( % vs %, p < . ). in both the groups, in planned cases, most of the time blood was issued immediately within the defined turnaround time except in where either transfusion was delayed or surgery was postponed. it happened only in trauma or surgical bleed cases. expiry of blood was decreased significantly due to no usage of blood ( . % vs. %, p < . ). during the period of study we obtained cases where the ist cross match was compatible but the ahg cross match was incompatible. during follow up none of the cases demonstrated any sign of hemolysis summary/conclusions: in developing countries like us, optimization of as during pretransfusion testing increases operational efficiency and significantly decreases the expiry of blood. results: during the period when absc was performed on pk , , donation samples were tested and , ( . %) were found absc positive. antibodies to red cells were identified in donations out of , ( . %) absc positive samples and in the rest, no irregular antibodies were detected. the prevalence rate for atypical antibody was . %. the top most frequent antibody specificities were: nonspecific cold antibodies ( . %), anti-e ( . %), anti-mi a ( . %), anti-m ( . %) and anti-le a ( . %). a total of , donations were screened for atypical antibodies by ih- and , ( . %) were screened positive. among these, anti-red cell antibodies were identified in , samples ( . %), which was significantly higher than those identified in pk screened positive samples (p < . ). the prevalence rate for atypical antibody as screened positive by ih- and with confirmed red cell specificities was . %, which was also significantly higher (p < . ). the top most frequent antibody specificities were: anti-mi a ( . %), anti-m ( . %), anti-le a ( . %), anti-e ( . %) and non-specific cold antibodies ( . %). anti-fy b was detected in cases, which would be missed detection by enzyme treated reagent cells on pk system. summary/conclusions: the performance of the ih- system using a -cell screening panel including one cell with mi(a+) expression and column agglutination technology with iat phase was superior in comparison with that of pk in the context of higher sensitivity in detecting more true positive results and higher specificity in detecting more true negative and less false positive results. this has translated into the advantages of reduction in workload of reference laboratory in performing less antibody identifications in those false positive samples as well as enhanced transfusion safety by removing more irregular red cell antibody positive plasma-containing components from the issuable inventory, which may potentially lead to haemolytic transfusion reactions. the prevalence of irregular red cell antibodies of . % in healthy blood donors in hong kong reflects more the true statistical figure. background: chronic red blood cell (rbc) transfusion is the upfront therapy for thalassaemia patients, however this therapy is featured by several adverse events including rbc alloimmunization. phenotype matched products transfusion policy can prevent alloantibody formation, but it makes routine transfusion more difficult for both the donor center and the transfusion service. a recent systematic review (franchini et al, blood transfus ) reported a rbcalloimmunization prevalence of . %, with a higher incidence against rh and kell systems in thalassemia intermedia patients. aims: the aim of our retrospective study is to evaluate the rbc alloimmunization prevalence in thalassemia patients transfused in a single center over a years period with limited phenotype matched rbc (rh and kell system antigens) units. methods: from to thalassaemia patients, with a minimum follow up of year and transfused with more than > rbc units, were included in our study. patients were studied for: blood group and rh / k phenotype determination, direct antiglobulin test (dat), irregular antibodies research (abirr). cross-match and detection of alloantibodies were performed using the indirect antiglobulin test by the column agglutination method. six-monthly dat and antibody screening were performed using the indirect antiglobulin test and enzymatic papain-treated rbc test. results: overall patients ( females, males) were included in our retrospective analysis: patients were affected by thalassaemia major and by thalassaemia intermedia. rbc alloimmunization prevalence was . % ( patients): patients were found to be positive for rbc alloantibodies, four with alloantibodies and autoantibodies. eleven alloantibodies were detected ( anti-h, anti-cw, anti-e, kpa, anti-jka, anti-jkb, anti-m and anti-lua). in out of alloimmunized patients we found an anti-e antibody reactive in enzymatic papain-treated rbc test only, in the third alloimmunized patient anti-kpa and anti-lua antibodies were detected, while in the remaining patients, in which auto and alloantibodies were detected, a severe autoimmune hemolytic anaemia (aea) requiring therapy was diagnosed. in these cases the appearance of alloantibodies is concomitant with the presence of autoantibodies. among the patients positive for alloantibodies, were affected by major thalassemia and one by intermedia thalassaemia summary/conclusions: in our experience a limited phenotype matched rbc transfusion policy showed a rbc alloimmunization prevalence similar to literature data: . % vs . %; we didn't find higher alloimmunization prevalence in thalassemia intermedia patients may be due to the low patients number. we believe that introduction, in our department, of an extended-phenotype matched transfusion, including antigens of the main group systems (fy, jk, mns) and the main rare antigens (cw, kp, lu), could reduce the risk of red blood cell alloimmunization in thalassemia patients. abstract withdrawn. background: undoubtedly, preventing alloimmunization has an advantage over overcoming its consequences. however, the high cost of technical and organizational aspects of preventive measures requires their scientific substantiation confirmed by clinical and laboratory data. selection of donors of the rhesus (d, c) and kell (k) antigens for the red blood cell transfusions to hematological patients has been regulated in the russian federation since . recipients with the phenotype c+c-transfuse red blood cell only with the same antigenic combination. for transfusions red blood cell obtained from k-negative donors are used. the compatibility of the donor and recipient with the antigens c, e, e, c w (rhesus system) and k (kell system) is additionally taken into account from april . that is, transfuse red blood cell that do not contain antigens in the phenotype that are not in the recipient's phenotype. aims: to evaluate the efficiency of red blood cell donor selection using antigens of rhesus (c, c, e, e, c w ) and kell (k, k) systems for the prevention of the recipient alloimmunization. methods: immunohaematological studies using equipment and reagents of biorad (usa) were performed in patients of the hematology clinic. non-hodgkin lymphoma was diagnosed in patients, acute leukemia in , multiple myeloma in , chronic lymphatic leukemia in , chronic myeloid leukemia in , aplastic anemia in , hemophilia in , myelodysplastic syndrome in , and other hematological diseases in . the frequency of detection of antibodies to antigen c ( . % vs . %) and to antigen e ( . % vs . %) decreased four times. the frequency of detection of antibodies to the c w antigen has not changed significantly ( . % vs . %, respectively). selection of antigens c (rhesus) and k (kell) has been carried out in the clinic since , therefore the immunization index for these antigens remained unchanged and amounted to . % vs . % for anti-c antibodies; . % vs . %for anti-k antibodies. alloantibodies to the antigens e (rhesus) and k (kell) were not detected for the entire observation period. summary/conclusions: research verified the effectiveness of alloimmunization prevention of recipients by selecting red blood cell for antigens c, c, e of the rhesus system and k (kell). the study concluded that selection of red blood cells for the antigens c w , e (rhesus) and k (kell) does not affect the level of alloimmunization of patients and is not clinically justified. background: in the russian federation, there is an order according to which patients requiring multiple transfusions, who are at high risk of immunological complications are to typed for red blood cell antigens: abo, d, c, c, e, e, cw, k, k. selection of erythrocyte-containing blood components is carried out taking into account the donorrecipient compatibility according to all the listed antigens. aims: analysis of results of immunological evaluation of patients of hematological clinic. methods: the study included first time patients of hematology clinic in - . typing of antigens of abo, rhesus, kell systems, screening and identification of antibodies were carried out using equipment and reagents from bio rad (usa). results: interpretation of results of immunohematological screening was complicated in ( . %) patients. the total number of complex cases was . the double population of red blood cell was most often determined in antigens of the rhesus system ( . % of the total number of patients) as a result of previous transfusion therapy. of those, chimera for the antigen e was detected in cases ( . % of patients with the chimera for rhesus and kell antigens), cin ( . %), sin ( . %), e - ( . %), cw - ( . %), k - ( . %). in such cases, donor red blood cells were chosen not carrying chimeric antigen for transfusions, in the presence of chimeras in both paired antigensred blood cell transfusion with the cc phenotype and / ee. chimera for abo antigens was detected in . % of the examined individuals. the discrepancy between the direct and reverse blood grouping of the abo system in patients ( . %) was due to a decrease in the production of antibodies - cases and the appearance of extra agglutinins - case. autoantibodies were detected in . % of all patients, including . % of patients, when they caused panagglutination phenomenon. upon detection of autoantibodies that complicate the individual selection of donors, transfused red blood cells that are compatible with antigens of abo, rhesus, kell, duffy, kidd, mns systems. alloantibodies were detected in . % of patients, including specific anti-din ( . %), anti-dcin ( . %), anti-kin ( . %); antibodies of unidentified specificityin ( . %), polyspecificin ( . %). summary/conclusions: the complexity of interpreting immuno-hematological tests in hematological patients is due to intensive transfusion therapy, changes in red blood cell antigens and appearance of nonspecific antibodies due to underlying disease. red blood cell for transfusion in these patients should be selected taking into account the expanded red blood cell antigen profile. abstract withdrawn. background: blood transfusion is an essential part of therapy for many patients. although life-saving for many patients, blood transfusion is not without risk. the main goal of blood transfusion services is that transfused blood should be compatible with the patient. the clinical and serologic evaluation, which allows for the transfusion of the most compatible (or "least incompatible") blood, requires a joint effort between the clinician and the transfusion medicine physician. aims: root cause analysis of incompatible cross matches in patients. methods: in this prospective study, total of , , crossmatches were performed over period of last four & half years, out of which units were found incompatible by column agglutination method-cat in polyspecific (anti-igg+ c d) gel media. a root cause analysis protocol was formulated to resolve incompatibility to ensure safe transfusion. results: on the evaluation of , , crossmatches, only units were found to be incompatible ( . %). the major cause for incompatibility found in patients was aiha-( . %). other causes of incompatibility were infections ( . %), multiple transfusions ( . %), trauma ( . %), evan's syndrome ( . %), rh negative mother ( . %), sca ( . %) & incompatibility due to dat positive packed red cells ( . %).the most common antibody found were anti-'c', anti-'s' & anti-'m'. summary/conclusions: the rca protocol involves a thorough evaluation of the patient's clinical condition and underlying pathology to identify the cause. a logical stepwise approach will enable provision of safe transfusion to the patient. background: antibodies to high-frequency antigens (hfas) are a transfusion hazard, as compatible blood is often very difficult to obtain. other clinically significant alloantibodies represent an additional transfusion risk. in patients treated with allogeneic bone marrow transplantation (bmt) recipient red cell alloantibodies may cause acute or delayed haemolysis of donor red blood cells (rbc) and contribute to morbidity and mortality. aims: the aim is to present the case of a patient with myelodysplastic syndrome (mds), multiple "common" alloantibodies and an additional alloantibody to a highfrequency antigen, treated with allogeneic bmt. methods: a forty-one-year-old caucasian patient with mds (raeb- ) was admitted to our hospital in january for unrelated allogeneic bmt. she previously received myeloablative conditioning therapy according to the flu / bu / atg protocol ( days of mg iv. fludarabine, days of busulfan mg iv, days of mg iv. antithymocyte globulin). the indirect antiglobulin test (iat), done in august and december of , was negative. according to anamnestic data, the patient had two pregnancies. she received red cell transfusions during childbirth and platelets in december . results: the patient's blood group was o rhd positive, iat positive. the donor blood group was a rhd positive, iat negative. phenotype of the recipient's rbcs, as well as the donor rbcs, was also determined. anti-e and -c w were found in the patient's plasma, but an additional alloantibody was suspected. the autocontrol was negative. column agglutination technology (cat) and tube technology were used to identify rbc antibodies. plasma was tested with pheno-matched rbcs, papain-and . m dithiothreitol-treated rbcs, as well as cord and autologous rbcs. adsorption and elution tests were done, excluding other "usual" clinically significant alloantibodies, and the patient received three incompatible (xm in iat, cat) yt(a+), e-, c w -, k-red cell units. the sample was urgently sent for an antibody investigation at the international blood group reference laboratory (bristol, uk). in the reference laboratory, anti-e, -c w and an alloantibody to a high-frequency antigen were confirmed, whose specificity was determined to be anti-yt a . anti-jk b was also suspected and later confirmed. before the patient was discharged from the hospital, she received eight more red cell units (yt(a+), e-, c w -, jk(b-)), during which she was serologically closely monitored. summary/conclusions: the results of the antibody investigation in this case study indicate the presence of multiple alloantibodies in a patient who has previously received immunosuppressive myeloablative conditioning therapy. in addition to the "common" alloantibodies (anti-e, -c w , -jk b ), an alloantibody to a high-frequency antigen (anti-yt a ) was detected in the patient. this patient was transfused with incompatible red cell units (yt(a+)) in an emergency, with no ill effects. although anti-yt a is rarely a clinically significant antibody, according to literature, it can cause immediate haemolytic transfusion reaction. additional risk were "common" clinically significant alloantibodies, especially anti-jk b , which was in this case extremely difficult to detect and had further complicated the selection of blood. background: the identification of an antibody against a high-incidence antigen always introduces a challenge due to the difficulty in finding compatible units of red blood cells (rbcs). in patients needing surgery it is important to minimize their transfusional needs by implementing patient blood management programs (pbm). tests that predict the clinical significance of antibodies, such as monocyte monolayer assay (mma) are also useful in guiding clinical decisions. kell blood group system contains highly immunogenic antigens. antibodies against these antigens are immunoglobulin g, and can cause severe hemolytic transfusion reactions and fetal anemia. results: case report we report the case of a -year-old female, with non-hodgkin lymphoma, chronic anemia and scoliosis with severe neurological compromise, proposed for lumbar spinal stabilization surgery. she had a total hip replacement surgery in , with unknown transfusion history. her obstetric history was g p a . the patient had no history of thromboembolic or hemorrhagic events. during pre-transfusional tests, she was typed as a rr and had a positive antibody screening test. the identification studies were suggestive of an antibody against a highincidence antigen, so the surgery was delayed until clarification of these results. she was also referred to a pbm appointment where her hemoglobin was improved from . g/dl to . g/dl by administration of ferric carboxymaltose iv and darbepoetin sc. the patient was phenotyped as kp(a+b-) with anti-kpb, an antibody against a highincidence antigen (> % prevalence worldwide). it is a rare antibody with variable reactivity, causing from none to moderate/delayed transfusion reactions. to access the clinical significance of this antibody, a mma was performed, resulting in a reactivity of . %, suggesting no clinical relevance, however it could be altered after transfusion of kpb+ blood. in order to find compatible rbc's, several family members were phenotyped, however they were all positive to the kpb antigen. in portugal there were no rr kp(b-) blood donors, as it is extremely rare, so we searched in the international rare donor panel (irdp) and two donors were found in spain. two units of compatible rbc's were requested prior to the surgery, which was performed successfully four months later without transfusional support. summary/conclusions: anti-kpb is a rare antibody that in some cases can cause hemolysis of the transfused kp(b+) red blood cells. the combination of kp(b-) and o rr, an extremely rare phenotype, presented a challenge in finding compatible rbcs. this case illustrates not only the complex transfusional and logistic problems that an antibody against a high-incidence antigen can pose, but also the importance of an efficient pbm programme to mitigate the transfusional needs in these patients. background: blood transfusion is an integral part of the supportive care for patients with sickle cell disease (scd). allo-immunization is a recognized complication to red blood cells transfusion (rbc) in those patients. this may result in difficulties in providing compatible blood, and may be associated with the risk of acute of delayed hemolytic transfusion reactions. aims: to describe transfusion management in a patient with scd who has multiple alloantibodies with difficulty in obtaining compatible blood, in order to highlight the importance and clinical consequences of this complication and suggest a possible management approach methods: an -years-old female patient with scd presented to our hospital with hemoglobin level of g/dl secondary to acute splenic sequestration. she had a history of multiple previous admissions and many previous rbc transfusions. blood grouping and pre-transfusion compatibility testing were performed in addition to phenotyping of the patient's red cells. screening was done using column agglutination technique by automated machine (ortho; usa) and antibody identification was performed manually using commercial cells identification panel. phenotyping for the patient was done using haemagglutination technique with mono-specific anti sera (bio-rad; switzerland). results: the patient was of group o rhd (positive). antibody screening was positive and antibody identification revealed probable anti-e and anti-fya with possible development of anti-k allo-antibodies, in addition to recent development of autoantibodies; giving pan-positive reactivity with the identification panels. phenotyping of the patient's rbcs was found to be r r and k-negative. other masked allo-antibodies of undefined specificities were suspected and no compatible blood was found. the clinical condition warranted a blood transfusion, so least incompatible phenotypically matched rbc unit was released. the patient developed acute hemolytic transfusion reaction with drop of the hb level to . g/dl. despite screening hundreds of rbc units, no compatible units were identified, and no transfusion was given. the patient was managed conservatively using hydration, analgesics, hydroxyurea, erythropoietin, intravenous immune globulin (ivig), steroids, and rituximab. hb level increased to g/dl in weeks, and the patient was discharged from the hospital. the sample of the patient was sent to a reference lab (institut fur klinische chemie und laboratoriumsmedizin-regensburg -germany) for further investigations, clarifications and advice for compatible transfusion in case of need. the report of the reference lab revealed the development of additional anti-m and anti-s with confirmation of the presence of anti-fya, anti-k and warm auto-antibodies. phenotyping of rbcs was confirmed by molecular diagnostic testing done in the reference lab; as r r, k-neg. summary/conclusions: finding compatible blood may be extremely difficult in patients with scd who develop multiple alloantibodies. it is therefore essential to perform an initial extended red cell phenotyping for the patients at diagnosis and to have on shelf ready phenotyped blood units for issuing to the patients, to minimize allo-immunization. transfusion may occasionally be avoided in allo-immunized patients, utilizing alternative options of treatment and reducing the risk of serious complications such as hemolytic transfusion reactions. background: red blood cell (rbc) antigens that are present on less than % of most populations are known as low incidence antigens and those present on more than % are known has high incidence antigens. the mns blood group system consists of antigens carried on glycophorin a (gpa), glycophorin b (gpb) or on hybrids of these glycophorins. there are low incidence and high incidence antigens in the mns blood group system. an individual that is homozygous for gp.mur will be negative for the high incidence jenu (mns ) antigen. anti-jenu was first described in a thai patient with thalassemia where only compatible units were found following screening of units. the jenu negative phenotype is a rare phenotype with an estimated frequency of . %. a male patient with a history of previous transfusion presented with an anti-e and a weak auto antibody with no apparent specificity. a donor unit selected for cross match (group o rhd positive, c+e-c-e+, k-) was incompatible with a reaction grade of + by column agglutination technology. the patient's sample and donor unit were referred to the red cell reference laboratory for investigation for a possible antibody to a low incidence antigen. aims: we aim to characterize the phenotype of the incompatible donor unit. methods: standard serological procedures were used to identify the antibody specificities in the patient's sample. blood group phenotyping of the patient and donor was performed by standard serological procedures. genotyping and zygosity testing was performed using polymerase chain reaction (pcr) high-resolution melting (hrm) assay. gp.mur is a gp(b-a-b) hybrid glycophorin resulting from a gene conversion event between gypa and gypb . this disruption to gpb impacts s expression. the donor was negative with anti-s moab (albaclone), positive with anti-s polyclonal (immulab) and negative with anti-s monoclonal antibody (immulab). this s and s phenotype was consistent with the previously reported examples of gp.mur homozygote jenu negative individuals. molecular testing was consistent with serology supporting gp.mur homozygosity and jenu negative phenotype. summary/conclusions: this donor has been added to our rare donor panel and their red cell donations are cryopreserved for future use in our rare donor frozen inventory. there is limited anti-jenu antiserum available to confirm the jenu negative phenotype. we currently rely on the serological profile of red cells presenting with the gp.mur phenotype, s negative and the discrepant s phenotyping to identify jenu negative donors. this case has highlighted the importance of following up unexplained serological incompatibilities. the development of a monoclonal antibody directed against jenu antigen would provide an opportunity to screen for suitable donors for this rare phenotype. background: molecules expressed on tumor cells are a target of interest for drug development by the use of monoclonal antibodies or blocking proteins. however these drugs have the potential to interfere in pretransfusion testing when the target molecule such as cd is also expressed on red blood cells (rbcs). recently, many drugs targeting cd have been developed but appropriate mitigation strategies and approach to selecting rbcs for safe transfusion is still an obstacle. aims: we describe a case of delayed hemolytic transfusion reaction (dhtr) by anti-jk a in a patient treated previously with cd targeted high affinity sirpa fusion protein alx . methods: a -year-old woman diagnosed with nasal cavity squamous cell carcinoma was enrolled in an alx clinical trial. her blood type was group ab, rhd positive, and the antibody screening test was negative for the past months. she had no previous transfusion history during the past two years. after two infusions of alx , two units of apheresis platelets were requested for transfusion. the blood bank noticed that the antibody screening was positive and further investigation was proceeded. results: antibody screening showed trace positivity in both panel cells (i & ii) at room temperature (rt) and °c albumin phase, and + at anti-human globulin (ahg) phase by tube method. the auto control was negative at rt and °c albumin phase, but + at ahg phase. antibody screening ( cells) and identification ( cells) all showed + at ahg phase using gel cards. direct antiglobulin test was + for anti-igg and + for anti-c d using gel cards. two units of rbcs were requested for transfusion after hemoglobin decrease to . g/dl. rbc genotyping was unavailable at the moment. as her previous antibody screening was negative (anti-jk a not detectable), e-, c-, fy b -rbcs were given as a second best option, considering the phenotype distribution of major blood groups in the korean population. the hemoglobin level was well sustained between . - . g/dl but it decreased again to . g/dl twenty days after rbc transfusion. further laboratory investigation was consistent with a dhtr. the patient was no longer being given alx , and antibody screening and dat decreased to - + reactivity. we presumed that antigen typing results would be reliable after chloroquine dissociation and cell washing using antisera that did not require ahg for testing. serologic phenotyping showed that the patient's cells were c+, e+, c+, e+, jk a -, jk b +, fy a +, fy b -, s-, s+, m+, n + . antibody identification using papainized panel cells revealed anti-jk a antibody. we concluded that the dhtr was due to anti-jk a , and jk a -, fy b -, s-rbcs were issued for further transfusion requests. the patient's hemoglobin level recovered to . g/ dl. the patient's genotype was later identified to be the same as serologic typing. summary/conclusions: communication with the physician and blood bank to perform adequate pretransfusion testing before administration of drugs targeted to cd is important to achieve safe transfusion for patients. serologic phenotyping using antisera which do not require ahg for testing can be used as a second option when genotyping is unavailable in a timely manner. background: transfusion is still a key treatment for sickle cell disease (scd) patients. as a result, these patients are much more exposed to transfusions' risks, the most feared one being a delayed hemolytic transfusion reaction (dhtr). we investigated a female scd pediatric patient with no known antibody, who was referred to us for a suspicion of two dhtrs. three transfusion episodes were reported (a total of four units collected from four donors). for the last transfusion, a premedication with rituximab was done. the patient was planned to undergo a bone marrow transplant with her brother as her donor. aims: to describe the molecular and serological workups needed to investigate a dhtr in a scd patient. methods: antibody identification and crossmatches were performed by iat gel testing with red blood cells/panels, which were used raw, papain-treated and trypsintreated. rbcs' phenotypes were determined by conventional techniques. semi-quantitative phenotypes were conducted by serial dilutions with a monoclonal anti-jk a (ms /seraclone â ). dna was extracted using the magna pure compact instrument (roche). sequencing of jk exons - was carried out by in-house techniques. results: the antibody identification showed a very weak anti-jk a , which was only reactive on papain-treated rbcs. autologous control was also only positive in this technique. dat and the eluate were negative. as the patient had recently been transfused (less than four months earlier), on this first sample we were neither able to perform autologous adsorptions, nor verify her jk a /jk b phenotypes. in order to rule out the imputability of an anti-lfa in the dhtr outcome, crossmatches with her donors' rbcs were undertaken. three out of the four donors were tested. apart from the anti-jk a reactivity, none of them was reactive. because the patient had previously been phenotyped as jk(a+b+), her jk gene was sequenced. her genotype was determined as jk* ( a, a, a, g)/jk* . to confirm this jk a variant allele, a family study was conducted. all her siblings were found to harbor the same genotype. her mother's and father's genotypes were jk* ( a, a, a, g)/ jk* and jk* /jk* , respectively. subsequently, autologous adsorptions were performed, which proved the anti-jk a to be an autoantibody. considering the weakness of this antibody, internal controls were used, in order to evaluate a possible dilution effect of this technique. finally, serial dilutions with the anti-jk a reagent showed a weakened jk a expression encoded by the jk* ( a, a, a, g) variant allele. this finding is consistent with the fact that the crossmatches between the proband's serum and her brother's rbcs were weaker than those performed with (jka+b+) rbcs. summary/conclusions: about a third of dhtrs are reported to happen in patients with no previous history of immunization. performing sensitive serological techniques in order to identify antibodies is necessary to select the most appropriate units. molecular work and extra serological testing can be useful to determine whether an antibody is an allo or autoantibody. even though in this case the anti-jk a was the only antibody identified, because it was proven to be an autoantibody, it is difficult to conclude if it was the cause of the dhtr. nevertheless, jk(a-b+) blood was issued, and no adverse events have been reported. luckily, the patient's bone marrow donor harbors the same variant allele. background: according to the aabb, a pre-transfusion sample must be obtained within days of transfusion if a patient has been transfused or pregnant in the preceding months. despite this safeguard, high risk patients (i.e. those recently transfused with a history of pregnancy or transfusion) may develop antibody during this day window. to avoid issuing incompatible red blood cells (rbcs) to these patients, a new antibody screen (abs) sample should be drawn and tested shortly before anticipated transfusion. aims: we report a case of a y/o man who presented to the ed (hospital day , hd ) with a post-fall intracranial hemorrhage and multiple fractures. anti-e and anti-jka were identified after admission on a new specimen prior to current specimen expiration (< days). methods: specimen # (s ) was sent on hd for type & abs (t&s) and crossmatch (xm) of rbcs. abs and immediate spin xm were negative; there was no patient history. by hd , he had negative t&s specimens (hd : s ; hd : s & ; hd : s ) and had been transfused rbcs (hd : ; hd : ) via electronic xm (exm). at hr on hd , rbcs were requested and could have been issued via exm since s was not expiring until midnight. however, given recent transfusions, bb staff first called the patient's nurse to review history. patient was uncommunicative, but had scars suggesting past trauma or surgery. s was requested and received at hr. results: s showed anti-e and anti-jk a in plasma and eluate. his hemoglobin/hematocrit (h/h) decreased from . ( . - . g/dl)/ . ( . - . %) on hd to . / . on hd . during this period, he underwent several surgeries without unexpected bleeding, documented jaundice or dark urine. two e-jk(a-) rbcs were transfused on hd , which he tolerated well with an increase of hemoglobin from . g/dl to . g/ dl. he did well post transfusion with stable h/h between . / . . to . / . . he was discharged on hd . repeat abs on s was negative. of the rbcs transfused before s , one was e+ and four jk(a+). the family reported that he was injured years prior and had been admitted to hospitals, but was unaware of transfusion. hospital # (h ) reported admissions years ago ( rbcs transfused) and years ago; all abs were negative. h admission was years ago with positive abs and inconclusive workup. h admission years ago showed negative abs. summary/conclusions: the patient developed a significant antibody response in less than days from the specimen collection, likely a secondary immune response to sensitization from a transfusion years earlier. a new specimen was requested prior to transfusion even though the existing sample (which was abs negative) had not expired. this approach identified new antibodies, preventing transfusion of incompatible rbcs, and a potentially serious hemolytic transfusion reaction. this case suggests that for high-risk patients, abs more frequently than every days may be beneficial. it is important to increase clinicians' and laboratorians' awareness of this issue. background: red cells with partial d antigen have historically been classified as such, based on the fact that the red cells type as d positive, but individuals make anti-d antibody when exposed to conventional d antigen. a definitive confirmation of the variant of d antigen is obtained after the rh d genotyping. aims: to present a case study of the patient's alloimmunisation with the present d partial antigen type dnb, most likely on previously received transfusions. methods: the patient's pretransfusion testing included the determination of the abo blood group and rhd type (id card diaclon abo/d dv+, dv-, reverse grouping, monoclonal antibodies, gel method), antiglobulin crossmatch, additional phenotyping (gel and tube methods), antibody screening, identification of the specificity of irregular anti-erythrocyte antibodies by commercially available red cell panels (id dia-panel bio rad gel method, panocell immucor, tube method) through an indirect antiglobulin test (iat) and enzymes. after routine rhd typing we continued further characterisation of the rhd antigen by serologic assay (bio-rad id-partial rhd typing),and finally by rhd antigen molecular genotyping (fluogene method on fluo vista machine). results: our patient is a year old woman with a diagnosis of tu mammae who was preparing for total mastectomy surgery. she had a history of blood transfusions twenty years ago, and she also had two births. the blood group typing was: o, ccdee, k-, fy (a-b +), jk (a+b +), ss, mn, le (a+b -). the agglutination reactions that we tested with anti d serums were strong ( +). the compatibility test with rhd positive donated blood units was positive. the presence of anti-d and anti-fya antibodies in the serum of the patient was determined. we prepared one compatible blood unit, rhd negative and fya negative, for a surgery. interpretation of the id-partial rh d typing set indicated that this is a diii category of d partial antigen. a sample of blood of our patient was sent to the blood transfusion institute of serbia, where molecular typing of d antigen was performed and the presence of partial form of antigen d, dnb type, was found. summary/conclusions: rhd positive patients or donors with anti-d antibody presents in their serum should be tested for d genotyping. the recommendation for further transfusions of our patient with dnb d partial and her alloimmunisation is to prepare d negative, fya negative erythrocytic blood components, and as a possible blood donor it would be labeled as rh d positive. background: the jr blood group system consists of jr a (jr ), a high frequency antigen expressed by the abcg gene. the individuals with jr(a-) phenotype are mainly found in the japanese population and may develop anti-jr a when stimulated by blood transfusion or pregnancy. anti-jr a is a dangerous antibody for pregnancy, but also could cause mild or moderate neonatal jaundice. aims: to conduct the antibody specificity identification of the high frequency antibody in a pregnant woman with history of pregnancy but no transfusion. methods: abo, rhd and some special blood group antigens were identified by tube method in saline. antibody screening and blood group specific antibody identification were performed by indirect antiglobulin test (iat) in gel column. the reagent cells treated with trypsin, chymotrypsin and papain, were used to test the antiserum to obtain the characteristic of antibody reaction. the antibody titer in the patient's serum was detected. dna sample was extracted and exons and adjacent intronic sequence of the abcg gene were sequenced. the sample of one family member was collected for testing. results: the blood groups of the patient were b, rhd(+), lu b (+) and kp b (+). the negative reaction of the serum reacted with all reagent cells were tested in saline, but positive ( +) in iat test, while the self-control was negative. the antiserums reacted strongly ( + in iat test in gel card) with the papain-treated cells, but kept the same reaction strength ( +) with trypsin-and chymotrypsin-treated cells, which indicated the possible existence of anti-jr a . the titer of igg antibody in serum was . in cross matching test, the red blood cell of the patient's brother with the same abo and rhd blood group with the patient was successfully matched with the serum of the patient. the sequencing analysis of the abcg gene in the patient and her brother revealed one homozygous nonsense mutation in exon (c. c>t, p.gln x). after the delivery of the pregnant women, no pathological jaundice was seen in the newborn. summary/conclusions: in the condition of the anti-jr a reagent was unavailable for the identification of jr a antigen in the patient, having an indication with anti-jr a by serological test, the alternative genotyping method was used. the most common silencing jr allele reported in asian population, especially in japanese population, was identified to indicate jr(a-) phenotype. immunohemotherapy, centro hospitalar vila nova de gaia/espinho, vila nova de gaia, portugal background: if the investigation of irregular/unexpected antibodies reveals a pattern in which all or most screen and panel cells are positive, with reactions in the same phase and with the same strength, along with a negative autocontrol, an irregular antibody to a high-prevalence antigen may be suspected. high-prevalence antigens are those that are present in almost all individuals ( % or more). fortunately, because these antigens do occur so frequently, it is not common to find a patient with an antibody to one of them. however, when it happens, it may become a troubling situation. aims: clinical case report of panagglutination in assessment of irregular antibodies. methods: collection of clinical data in scl ınico â and sibas â applications. results: woman, years old, o rhd+, previously transfused with red blood cells concentrates in , was proposed to a correction surgery of a periprosthetic hip fracture. pretransfusion serologic tests were requested and irregular antibodies were detected ( + in all the screening cells). in order to identify the specificity of the antibody, a panel of cells was tested; the result was considered inconclusive, due to positive reactions ( +) with all test cells in liss/coombs and atypical positivity with dragging in all cells in enzymatic environment. autocontrol and direct antiglobulin test were negative. it was decided to send two blood samples to the reference laboratory for a more complete immunohematological study. compatibilization of red blood cells to this patient was also requested. during the waiting period, haematopoiesis was optimized. although the patient did not present anaemia at admission, the analytical study revealed iron deficiency; therefore, supplementation with intravenous iron was performed. the reference laboratory also obtained a panreactive panel ( + with all cells) in liss/coombs and weak positivity in papain. after allo-adsorption, the search for irregular antibodies was negative. an anti-yt a , apparently without clinical significance (negative igg and igg ) was then identified. transfusion was not needed either during or after the surgery, with a good recovery of the haemoglobin value in the postoperative period. summary/conclusions: yt a , which belongs to cartwright system, is a high-prevalence antigen in all populations. anti-yt a , an igg antibody stimulated by pregnancy or transfusion, is not as uncommon as we may think, which suggests that it is reasonably immunogenic. these antibodies are not generally considered clinically significant, but there are reported cases of acute and delayed haemolytic transfusion reactions in which anti-yt a has been implicated. therefore, although the described pattern of panagglutination in assessment of irregular antibodies may suggest the presence of an alloantibody directed against a highfrequency antigen, it is very important to confirm that hypothesis, recurring to a reference laboratory if necessary, to identify the antibody and to determine its clinical relevance. even if the identified antibody is associated with rare haemolytic transfusion reactions, it is crucial to optimize haematopoiesis when it is not an emergent procedure, in order to minimize transfusion and its associated risks. both for emergent and elective procedures, the creation of a national database of patients with already identified irregular antibodies would facilitate the administration of red cells concentrates without the implicated antigen. aims: to investigate the frequency and explore the genomic characterization of jk (a-b-) phenotype in blood donors in harbin, china. methods: all samples were screened for jk(a-b-) phenotype using a direct urea lysis test. and the results were confirmed with by iat using anti-jka and anti-jkb with a standard tube test. additionally, polymerase chain reaction amplification and sequence analysis of the jk gene were performed. results: from blood samples, four donors with jk (a-b-) were selected, at a frequency of . %. among these four samples available for sequencing jk gene, a total of two genotypes were discovered: heterozygote of ivs - g>a combining with heterozygote of g>a (gly glu) and heterozygote of g>a (gly glu) combining with heterozygote of c>t(thr met). summary/conclusions: the frequency of jk(a-b-) phenotype in blood donors in harbin area was lower than the reported data from the populations in other areas of china and in finland, but higher than that in japan. ivs - g>a, g>a and c>t were common mutations in the before reports, while g>a was reported first time. in addition, it is an effective measure which establish the jk(a-b-) phenotype donors in this region, to solve the blood transfusion problem in patients with anti-jk . background: blood types, indicating the type of blood group antigen expressed in the red blood cells, is determined by the type of allele at the blood group gene locus. therefore, when allele frequency of each blood group gene is determined, it is possible to predict the frequency of a specific blood type donor with a homozygous allele. it is also possible to estimate the proportion of donors within a particular blood type through combination of specific alleles. and because the ratio of blood group allele differs between ethnicity and race, this can be used as basic data for population genetics and anthropology. therefore, we present a study that examined the allele frequencies of blood group systems in the korean population through blood group genotyping. aims: the purpose of this study is to determine the frequencies of blood group alleles in the korean population, to predict the proportion of homozygous donors, and to obtain the basic data of population genetics. methods: , blood donors from age to were recruited at korean red cross blood centers located nationwide. acquired samples were examined by blood group genotyping methods using the rbc genotyping system id core xt (progenika biopharma). for each donor, genotypes of blood group systems, excluding abo and rhd, were identified. calculation of the frequencies of blood group alleles in the korean population was done. results: we conducted molecular genotyping of the rhce, kell, kidd, duffy, mnss, diego, dombrock, colton, cartwright, and lutheran blood group systems. the allele frequencies of these blood group systems in the korean population were estimated as follows. -rhce*ce . %, rhce*ce . %, rhce*ce . %, rhce*ce . % -kel*k_kpb_jsb allele % -jk*a allele . %, jk*b allele . %, jk*b_null allele . % -fy*a allele . %, fy*b allele . % -gypa*m allele . %, gypa*n allele . % -gypb*s allele . %, gypb*s allele . %, gypb*mur allele . % -di*a allele . %, di*b allele . % -do*a allele . %, do*b allele . % -co*a allele % -yt*a allele % -lu*b allele % summary/conclusions: the significance of this study is accumulation of data on the allele frequencies of blood group genes through highly accurate genotyping method in the east asia region. this enables the prediction of the proportion of donors with a combination of specific blood group alleles in the korean population, which accounts for a decent percentage of the population in this region. background: in donors from arabian countries only little is known about blood groups other than abo and rhesus. during the last years increased migration to central europe has put a focus on the question how to guarantee blood supply for patients from these countries, particularly because hemoglobinopathies with the need of regular blood support are more frequent in patients from that region. aims: blood group allele frequencies should be determined in individuals from syria, other arabian countries, and iran by molecular typing. methods: as most blood groups are defined by single nucleotide polymorphisms (snps) we introduced a maldi-tof ms assay to detect alleles encoding blood groups including kk, fy (a/b), fy null , c w , jk(a/b), jo(a+/a-), lu(a/b), lu ( / ), ss, do (a/b), co(a/b), in(a/b), js(a/b), kp(a/b), rhce*c. c>g, and rhce*c. c>g. additional blood groups and polymorphisms like yt(a/b), s-s-u-, vel null , co null and rhce*c. g>t were tested by pcr-ssp. a total of probands including individuals from syria, from iran, from the arabian peninsula and from northern african countries were included. results: % of the donors were homozygous for the fy null (fy*- t>c, fy* n. ) mutation, . % carried the heterozygous mutation. . % of the syrian probands were heterozygous for the do* c>t mutation (both, do*jo and do*jo ; jo(a+/ a-)) that is virtually unknown in caucasian donors. . % of the syrian donors heterozygously carried the kel* . allele coding for js(a) (phenotype js(a+/ b+)) that is very rare in caucasians. however, no homozygous kel* . carriers were identified. . % of the syrian and . % of all donors were negative for yt*a, which is definitely more frequent than in europeans. one donor from northern africa homozygously carried the gypb*c. c>g, intron + g mutation, inducing the s-u+ w phenotype. . % of all and . % of northern african donors were heterozygous for the rhce*c. c>g substitution, . % of the syrian donors carried rhce*c. c>g (heterozygously) and . % of all donors were heterozygous for rhce* g>t. heterozygosity for vel deficiency (vel*- ) was detected in individuals ( %; of them from syria) whereas only one syrian donor carried the homozygous mutation. none of the donors carried the aqp *c. delg (co* n. ) mutation that induces the co null phenotype. summary/conclusions: the study provides a first overview on a number of different blood group alleles in blood donors from arabian countries. some blood group alleles that largely are lacking in europeans but had been described in african individuals are present in arabian populations at a somewhat lower frequency. in single cases it could be challenging to provide immunized arabian patients with compatible blood. methods: three unrelated individuals ( blood donors and one pregnant woman) of polish origin who were typed as ab group with a very weak a antigen and normal b antigen expression were subjected to extended abo typing. in one case family studies were performed (blood samples from donor's mother, father and sister). sequencing analysis of this donor dna was performed three times (from two blood samples and buccal swab). serologic investigations were performed with standard methods: /gel cards diaclon id abo/d (anti-a: clone a , anti-b: clone g / , anti-a,b: clone es , es + birma + es ; bio-rad) and diaclon id abd-confirmation for donors (anti-a: clone m / = la- ; bio-rad); /tube techniques with: anti-a (birma ; a- h , a s.pa m , c. d ), anti-b (lb- , b- f , c. a ). genotyping was determined by rbc fluogene abo basic kit (inno-train, germany) and by sequencing of + . -kb site of abo gene to cover sequences ranging from the end of intron to utr of the abo gene. additionally sequence of exon of the abo gene was analyzed. results: abo typing showed normal b and a very weak a antigens on rbcs of all three individuals ( blood donors and one pregnant woman). the a antigen was detected by tube technique only using anti-a clones: birma ( + to +), a- h ( + to +) and c. d (weak+ to +); negative reaction of a antigen typing by gel cards was observed. the sera of all individuals contained anti-a antibodies. commercial pcr-ssp kit revealed three heterozygous a/b genotypes (absence of delc typical for abo*a alleles). in all these individuals abo sequencing of . -kb fragment confirmed the heterozygous genotype with polymorphisms characteristic for abo*b. allele ( a>g; c>g; c>t; g>a; c>a; g>c; g>a) and detected a novel abo*a allele sequence with duplication-based insertion of bp after position (abo*a c.dup _ ; gcaggacgtgtccatgcgccg). as a consequence, the online protein translation predicts an in-frame duplication of seven amino acids after codon (p.dup_ _ qdvsmrr), with synonymous change of the repeated codon (cgc>cgg) and (cgg>cgc) but both coding arginine (r). inheritance of abo*a c.dup _ allele was confirmed by family studies of one donor: his father and sister had a/b genotype associated with normal a and b antigens expression; his mother had normal a antigen expression. she carried abo*a . allele and the same abo*a c.dup _ allele as a son. summary/conclusions: a novel a weak allele at the abo gene detected in three unrelated polish individuals is an in-frame insertion of seven amino acids to the wild-type glycosyltransferase a. the stability of the encoded protein may be affected causing the weak a phenotype. the inheritance of this mutation was confirmed in the family studies. background: since the cloning in of cdna corresponding to mrna transcribed at the blood group abo locus, polymorphisms and phenotype-genotype correlations have been reported by many investigators. although many subgroups have been explained at the genetic level, unresolved samples are still encountered in clinical practice. we report here the result of an abo investigation of a sample from a swedish blood donor that showed a very weak agglutination of rbcs with anti-a in routine forward typing. aims: to elucidate the genetic basis of the apparent weak a subgroup. methods: routine abo genotyping by pcr-asp and pcr-rflp including pcrbased analysis of the upstream cbf/nf-y-binding enhancer region was carried out. further genetic analysis was performed by dna sequencing of abo exons - (including base pairs of the adjacent introns) and the proximal promoter. flow cytometric testing of rbcs was performed with monoclonal anti-a, anti-b and anti-h. results: the weak agglutination of erythrocytes with anti-a was accompanied by the expected lack of anti-a and anti-a in plasma. abo genotyping gave the genotype abo*a . /o . usually consistent with normal expression of a antigen. enhancer analysis resulted in an amplification product corresponding to the expected single cbf/nf-y binding motif. flow cytometric testing of the sample showed a antigen expression with an almost chimeric pattern where the majority of the cells (approximately %) expressed the a antigen at a very low level, marginally distinguishable from the group o control. the remaining approximately % of the cells displayed an a antigen level ranging from normal to very weak. genomic abo sequencing showed an abo*a . -like allele except for a novel mutation located in intron , c. + g. the o allele had an additional snp, c. g>a, consistent with the abo*o . allele variant summary/conclusions: a previously unreported variant, c. + a>g, likely effecting the -donor splice site of intron was found in an a weak sample. this type of mutations is expected to decrease mrna stability and/or cause skipping of the preceding exon in the mrna. however, small amounts of full-length enzyme might still be made, being able to give rise to the weak a antigen expression seen in this individual. interestingly, this mutation is very similar to the genetic variant underlying the weak a subgroup a finn . in this case, however, the c. + a>g mutation is located in the -end of intron and is predicted to cause partial skipping of exon . strikingly, the a finn phenotype also results in a pseudochimeric pattern by flow cytometry but with only approximately % positively staining erythrocytes. due to the well documented lack of a-allele-derived mrna in peripheral blood, further transcript studies could not be undertaken. further studies are needed to investigate the exact mechanisms underlying the pseudochimeric pattern observed by flow cytometry in these two interesting genotypes/phenotypes abstract withdrawn. background: abo is the clinically most relevant blood group system in transfusion and transplantation medicine. abo genotyping is potentially useful in clarifying serologic blood grouping discrepancies. this scenario includes inherited subgroups alleles, temporary acquired variant abo phenotypes in disease or pregnancy, and chimerism due to exchange of progenitor cells early in fetal life or after blood progenitor cell transplantation. aims: to investigate the molecular basis for abo discrepancies detected in clinical samples, including donors and patients, sent to our reference laboratory during the past years. methods: if routine abo grouping showed weak agglutination or forward vs reverse typing discrepancy, further abo typing studies were performed manually. adsorption-elution tests were also performed in some cases with polyclonal anti-a and anti-b to confirm whether a or b antigens were weakly expressed on the rbcs membrane. a pcr approach using sequence specific primers for a , b, o and o alleles was used for initial genotype determination. the full abo coding region was analysed as previously described in selected samples for which abo discrepancy was still unexplained. allele specific fragments spanning exon , intron and exon were amplified using a forward primer targeting the g nucleotide (to exclude o alleles amplification) in combination with either b, a or a generic reverse primer. analysis was carried out by sanger sequencing. results: a total of samples with suspected inherited abo subgroup alleles were selected for further molecular studies by sequence analysis. a subgroup alleles: in out of samples with suspected a subgroup alleles, the c. insg insertion was detected corresponding to the abo*ael. allele. the abo*aw . - variant, a hybrid a -o v allele, was found in cases. in case we found the c. g>c change, previously reported associated with weak a antigen expression. finally, a novel c. c>g change was detected in an a allele. b(a) or cis-ab suspected alleles: the abo*b(a) variant carrying the c. a>g change was found in of samples with bo genotype but a weak antigen expression. in the remaining cases, a consensus b allele was detected, thus pointing to a potential chimerism as the cause of the results observed in abo grouping. finally, we have identified an abo*b . allele carrying the nucleotidic change c. a>g in the context of an abo phenotype vs genotype discrepancy. summary/conclusions: the sanger sequencing approach applied in this study have proved to be informative and helpful to determine the molecular basis of abo grouping discrepancies with suspected inherited subgroups. we found mutations, within exon of the abo gene, in out of samples, including novel alleles. chimerism was suspected in cases of a antigen expression in samples with b o genetic background carrying an apparent normal b allele. we are evaluating at the moment a deep sequencing approach by next generation sequencing to determine the presence of a small amount of a minor allele in the presence of a large surplus of the other two alleles. background: recently, the multiple pregnancy rate has been increasing due to advances in artificial fertilization including in vitro fertilization-embryo transfer. most dizygotic twins have dichorionic placenta, but % of them share the placenta. monochorionic dizygotic twins can have blood chimerism, leading to double rbc populations in routine abo serologic typing. recently, more sensitive and objective column agglutination tests with automated systems are being widely used. therefore, blood chimerisms in dizygotic twins can be detected more easily by routine abo blood typing. aims: we report congenital blood chimerism in monochorionic dizygotic twins of triplets, found incidentally during abo serological testing and confirmed by abo genotyping and str marker analysis. methods: a -year-old male (one of triplets) was admitted to the hospital for medical checkup. he did not have any history of transfusion or bone marrow transplantation. routine abo blood grouping test was performed using automated blood bank system ih- ; however, it showed abo discrepancy. the red blood cells showed double cell populations in a gel column with anti-a and anti-b. we carried out abo genotyping both from the blood and from a buccal swab. for the further evaluation, we performed abo serologic testing, abo genotyping, and str marker analysis in his family members. results: among the triplets, blood chimerism was demonstrated in the patient and his brother. they both showed a b phenotypes in the serologic test and tri-allelic abo genotypes in the blood, a /b /o . however, in buccal swabs, the patient showed a /o and his brother showed b /o . other members of the family (father, mother, and dizygotic sister) had regular abo blood types in the serologic test. we performed str analysis in the triplets and parents. eleven loci (d s , d s , d s , csf po, th , d s , d s , d s , d s , d s , and fga) revealed more than one additional allele in the blood sample, apart from those in the buccal swabs. str marker analysis showed that his brother too had blood chimerism. summary/conclusions: we found blood chimerism in monochorionic dizygotic twins of triplets during routine abo blood typing, and this was confirmed by str analysis. as the application of assisted reproductive technology increases, the incidence of blood chimerism will also increase. blood chimerism can often create confusion during abo serologic typing and microchimerism can be overlooked in routine methods. therefore, it is helpful to use an automated blood bank system to improve sensitivity and blood chimerism should be considered if abo blood grouping reveals double populations. background: expression of abo transferase genes can be affected by genetic variants located within the coding sequence, at splice junctions, in the proximal promoter and in the intron enhancer. here we describe five new alleles with singlenucleotide substitutions found in samples with discrepant or unusual abo serology. aims: to resolve serological discrepancies or unusual serological findings in the abo blood group system by molecular methods, in particular by sanger sequencing. methods: forward and reverse abo phenotyping was performed by the gel or tube methods. genomic dna extracted from whole blood was pcr amplified to cover the entire abo coding sequence, splice junctions, proximal promoter and intron enhancer. amplification products were sanger sequenced directly or after cloning in a bacterial host. results: case # is a patient with an unclear abo phenotype: forward type b, reverse type ab. sequencing of genomic dna and cloned abo exon detected variant c. - t>g in heterozygosity on an otherwise common a allele, and in trans an abo*b. allele. case # is a caucasian donor with an abo discrepancy: forward type aweak/o, reverse type a. sequencing also detected variant c. - t>g in heterozygosity on an a background, and in trans an abo*o. . allele. given that this variant is located near the intron splice acceptor site, abo* - g transcripts are postulated to undergo altered splicing, leading to an aweak phenotype. case # is a prenatal sickle-cell disease patient with an abo discrepancy: forward type aweak, reverse type a. dna sequencing detected variants c. c>t (pro leu) and c. t>a (tyr asn), both in heterozygosity on an otherwise common a allele, with an abo*o. . allele in trans. thus, the data establish an association of allele abo* t, a with an aweak-like phenotype. case # is a donor with an abo typing discrepancy: forward type o, reverse type a. sequencing detected variant c. c>g (pro arg) in heterozygosity on an a background, and in trans an abo*o. allele. an interpretation of the data is that variant c. c>g weakens the activity of the a transferase, with allele abo*a ( g) encoding the aweak-like phenotype detected by serology. case # is a year-old patient with an abo discrepancy: forward type o, reverse type ab. sequencing of genomic dna and cloned abo exon detected variant c. g>c (gly ala) in heterozygosity on an a background, and in trans an abo*o. . allele. the serology and molecular results suggest that allele abo*a ( c) encodes a cisab weak phenotype. case # is a caucasian donor with an abo typing discrepancy: forward type o with a weak agglutination with anti-ab, reverse type o. dna sequencing detected variants c. g>a (glu lys) and c. g>a (asp asn), both in heterozygosity, in trans, and on a backgrounds. variant c. g>a by itself constitutes allele abo*a . . the phenotype encoded by abo* a is uncertain. summary/conclusions: molecular characterization of abo alleles can help in their future identification and discrepancy resolution. background: expression of abo transferase genes can be affected by genetic variants located within the coding sequence, at splice junctions, in the proximal promoter and in the intron enhancer. here we describe five new alleles with singlenucleotide substitutions found in samples with discrepant or unusual abo serology. aims: to resolve serological discrepancies or unusual serological findings in the abo blood group system by molecular methods, in particular by sanger sequencing. methods: forward and reverse abo phenotyping was performed by the gel or tube methods. genomic dna extracted from whole blood was pcr amplified to cover the entire abo coding sequence, splice junctions, proximal promoter and intron enhancer. amplification products were sanger sequenced directly or after cloning in a bacterial plasmid vector. results: case # is a year-old pregnant female with an abo typing discrepancy: forward type o, reverse type a. pcr-rflp predicted abo*a /abo*o . sequencing detected variant c. insg (val gly>fs ter) in heterozygosity on an otherwise common a allele, and in trans an abo*o. . allele. it is unclear how the early truncation of the a transferase encoded by allele abo* insg still allows for some residual enzyme activity, as suggested by the reverse a type. case # is a recently-transfused year-old black patient with an unresolved abo type. sequencing detected variant c. a>g (silent) in homozygosity and variant c. c>t (ala val) in heterozygosity, both on an o background, with an abo*b. allele in trans. although variants c. a>g and c. c>t are likely of no consequence to the abo phenotype of this patient, they are reported here as components of a new abo*o ( g, t) allele. case # is a year-old prenatal female with a rhd typing discrepancy. failure to yield an abo genotype on blood-chip (progenika), a genotyping microarray that interrogates polymorphic positions in rhd and abo, prompted dna sequencing. sequencing of genomic dna and cloned abo exon detected variant c. c>t (arg cys) in heterozygosity on an abo*b allele background, and in trans an abo*o. . allele. the phenotype encoded by allele abo*b( t) is predicted to be b, as evidenced by forward typing on immucor neo and reverse manual typing. case # is a prenatal black patient with an abo typing discrepancy: forward type o in gel, a + mixed field (mf) in tube. reverse type on a cells + in gel, / + in tube. sequencing of genomic dna and cloned pcr products covering exons - detected variant c. g>c (asp his) in heterozygosity, and in trans an abo*o. . allele. case # is the newborn baby of case # , with a forward type a + mf in gel, a + mf in tube. sequencing of the baby's dna detected variant c. g>c (asp his) in heterozygosity, and in trans an abo*b. allele. from these results it is inferred that the phenotype encoded by allele abo* c is a -like. case # is an year-old hispanic donor with an abo typing discrepancy: forward type a, reverse type o. sequencing of genomic dna and abo exons - and - detected variant c. c>t (gln ter) in heterozygosity, and in trans an abo*o. . allele. the truncation of the a transferase at such a relatively late position is consistent with the retention of some enzyme activity, explaining the forward a type encoded by allele abo* t. summary/conclusions: molecular characterization of abo alleles can help in their future identification and discrepancy resolution. background: expression of abo transferase genes can be affected by genetic variants located within the coding sequence, at splice junctions, in the proximal promoter and in the intron enhancer. variants reported to date in the intron enhancer include large deletions, small deletions and single-nucleotide substitutions. here we describe four new alleles with single-nucleotide substitutions found in samples with discrepant or unusual abo serology. aims: to resolve serological discrepancies or unusual serological findings in the abo blood group system by molecular methods, in particular by sanger sequencing. methods: forward and reverse abo phenotyping was performed by the gel or tube methods. adsorption-elution by the heat elution method and testing for h and a substances in saliva were performed by following the procedures in the aabb technical manual. genomic dna extracted from whole blood was pcr amplified to cover the entire abo coding sequence, splice junctions, proximal promoter and intron enhancer. amplification products were sanger sequenced directly or after cloning in a bacterial plasmid vector. background: inactive alleles of the fut could be decreased or aborted the activity of the fucosyltransferase, which results in to form the bombay or para-bombay phenotype with weak or no h antigen expression on erythrocytes. now many para-bombay individuals have been found in the chinese population. according to names for h blood group alleles v . of red cell immunogenetics and blood group terminology working group of the isbt, fut alleles were identified for bombay or para-bombay phenotype around the world. aims: the study was explored the distribution of fut alleles for the chinese individuals with para-bombay phenotype. methods: the samples were come from the blood donors or the patients. the a, b, h antigens were determined using conventional serological method according to the manufacture's instruction. the sequences of the full coding region for fut was amplified, then amplicon was purified with enzymes digestion and used as template for sequencing bidirectionally. all nucleotide sequences obtained were analyzed and compared with standard fut sequence. results: nineteen chinese individuals with para-bombay phenotype were identified. ten of them were the donors and nine individuals were come from the hospital. the rbcs had a very weak agglutination reaction with anti-h in the most of the individuals. fut homozygous mutations were found in the individuals and fut heterozygous changes were existed in individuals after bidirectionally sequencing. . %, . %, . %, . %, . %, . %, . %, . % respectively in the individuals with para-bombay phenotype. according to our previously reports, the fucosyltransferase activity of fut * n. (c. _ delag), fut * w. (c. c>t) and fut * w. (c. c>t) were abolished in vitro assay, while fut mrna levels of them had no effect compared with wild type. summary/conclusions: the fut mutations in the para-bombay individuals were various. the most common fut allele in the chinese individuals with para-bombay phenotype was fut * n. (c. _ delag). background: the regulatory mechanism of the abo gene is complicated and has been investigated extensively.variation in a antigen expression was recognized very early in the twentieth century and the a blood group was divided into a and a . later the a blood group was subdivided further based on characteristic reactivity with human polyclonal antisera, i.e., strength of reactivity and presence of mixed field agglutination; presence of anti-a , and whether a or h blood group substance was present in the saliva of secretor subjects. mutations critical for abo blood group phenotypes have predominantly been found in exons and of the abo gene, both of which encode the catalytic domain of abo glycosyltransferase. in our case report we show how mutation ranging from single nucleotide in the intron enhancer element can alter the efficacy of enzyme and alter antigen expression. aims: this study aims to investigate the molecular basis of discrepant results of abo forward/reverse typing in blood donor. methods: the abo typing was performed using tube technique and column agglutination tests (bio-rad, grifols). standard tests were completed with adsorption-elution study using o plasma as a source of anti-a, and with saliva testing for presence of a and h substances. we performed quality control for these methods. abo group genotyping was performed using pcr with sequence-specific primer by commercial kit (abo-variant; bag healthcare, lich, germany). pcr-amplified exons and intron enhancer were subject to bi-directional dna sequence analysis using standard sanger dideoxy chemistry. seqscape software (abi) was used to analyze sequence data by comparing the obtained sequence to a reference sequence from ncbi. results: standard serological forward tests identified blood group o, however, only anti-b iso-agglutinins were present. anti-a in adsorption-elution study was successfully adsorbed and eluted from the investigated cells. a and h substances were detected in saliva. abo genotyping using pcr-ssp indicated genotype o v/a . dna sequence analysis showed result abo*a ( + a), abo*o. . . the specimen was revealed as an a subgroup, probably a m with an unusual genetic variant in the intron region of the abo gene, the enhancer of the gene expression. summary/conclusions: we report the first case of abo*a ( + a), the mutation located in the enhancer region of gene expression in allele a, that causes discrepant results not only in abo forward/reverse typing but also in molecular blood grouping tests. based on our serological findings, this subgroup is considered as a m . background: a chimera is a single organism composed of cells with distinct phenotypes and/or genotypes. several different types of chimeras are described: artificial, twin and dispermic. the artificial chimerism can be seen following hematopoietic stem cell transplantation, or more transiently following blood transfusion. the second type may also be inherited most commonly through blood exchange in utero between twins. dispermic chimerism is induced by the fertilization of two maternal eggs with two spermatozoa and their fusion into one body. this one is also called tetra-gametic chimerism. in transfusion medicine, chimeras are often detected when mixed field reactivity is observed in abo/d typing or, less commonly, when phenotyping for other blood group antigens. aims: this investigation was prompted by finding a double population of erythrocytes in a surgery patient with no transfusion history. our aim was to investigate the chimera and determine the underlying abo genotype of this patient. methods: routine blood grouping was performed by column agglutination. separation of the double cell populations was performed by differential agglutination with igm anti-d (immuclone, anti-d fast igm, clone: d - , immucor). initial abo genotyping was performed by pcr-ssp (fluogene; inno-train diagnostik gmbh); further resolution was performed using in-house pcr-asp and pcr-rflp methods. next generation sequencing (monotype abo; omixon using illumina sequencing platform) and sanger sequencing analysis were also performed. identification of reference alleles was investigated by fragment analysis of short tandem repeats (str) polymorphisms. results: double population was found in column agglutination in tests with anti-a and anti-ab, and subsequently when typing for d and c antigens, with approximately % of o d+c+ cells. the patient's genotype was identified as abo*o. /*a by ce-certified pcr-ssp kit (fluogene). routine pcr-asp and pcr-rflp could not resolve the patient's genotype possible abo*a /*o genotype was detected by pcr-rflp, but the pcr-asp analysis gave an apparent abo*a homozygote result. sanger sequencing of abo exons and also gave anomalous reactions: no abo*a allele was detected. homozygosity for c. delg was observed as well as heterozygosity for c c/a. this result therefore suggests the patient's genotype is abo*o. /*o. . . next generation sequencing (omixon) revealed the same result. however, when pcr amplification of the cbf/nf-y enhancer vntr -region was performed, possible heterozygosity was observed, i.e. a weak band representing a single copy, and one representing copies of the enhancer region were present. presence of a single copy of the -bp cbf/nf-y enhancer vntr region is unique background: del is a very weak form of d antigen with low density expression of d antigen on the surface of red blood cell, which is generally typed as d-blood group as couldn't form agglutination in routine rhd blood group testing and could only be detected by the non-routine adsorption-elution test. in the east asian and southeast asian population, - % of the individuals with serologically apparent d-phenotype are not these with truly d-phenotype, but del phenotype, which is very rare in caucasian and black ethic groups. and the rhd* el. (rhd* a) is most prevalent (> %) in del people in these regions, so the del carried this allele was commonly known as "asia type" del. in previous studies, no alloanti-d was observed in a large cohort of chinese "asia type" del pregnant women with d+ fetus to indicate no occurrence of alloanti-d immunization against d+ red cell in "asia type" del individuals. aims: to conduct genotyping analysis in the chinese patients having serologically apparent d-phenotype simultaneous with alloanti-d to confirm the existence of the "asia type" individuals to produce alloanti-d or not. methods: from to , the blood sample of the patients or pregnant women identified with alloanti-d in our reference lab were collected. d antigen was confirmed again using the blend anti-d reagent (clone th- /ms- , igm/igg) by tube method in saline and indirect antiglobulin test (iat) in gel card. the zygosity of rhd gene was detected by hybrid rhesus box pcr with psti digestion. for the samples with d or dd genotypes obtained by rhd zygosity analysis, multiplex ligation-dependent probe amplification (mlpa) genotyping was conducted for rhd genotyping analysis. results: a total of serologically apparent d-chinese patients (female, n = ; male, n = ) with alloanti-d were identified. different titers of alloanti-d from : to : (≤ : , n = ; > : , n = ) were detected including few cases with mixed antibodies (anti-d mixed with anti-c, n = ; anti-d mixed anti-e, n = ). serological rhd typing confirmed the serologically apparent d-phenotype. rhd* n. / n. (homozygous rhd gene deletion) genotype was identified in majority of them ( / , . %) by rhd zygosity analysis, while rhd* n. / n. genotype (n = ) and rhd* n. / n. genotype (n = ) carried the rhd non-functional hybrid alleles were detected by mlpa. summary/conclusions: compared with the distribution of average % frequency of "asia type" del in serologically apparent dpopulation in guangzhou of china, no one case of "asia type" del was identified in the cohort of serologically apparent d-patients with alloanti-d in this study. this also provides evidence to confirm no occurrence of alloanti-d immunization in "asia type" del individuals. aims: a serologically rhd-negative donor was found to be rhd-positive in the routine rhd screen. to solve the discrepancy between serology and molecular screen, the sample was sequenced on dna and rna level. methods: phenotyping on id/iat-cards (bio-rad) was done using commercial anti-d antibodies. the adsorption-elution analysis was performed using an in-house pool of polyclonal anti-d antibodies. furthermore an antibody d-screen was performed (diagast). for rhd genotyping rh-type and partial d-type assays (bag health care) were carried out. the sample was further characterized by exon sequencing including flanking intronic regions. rna was extracted from whole blood, reverse transcribed and the cdna sequenced. for amplification and sequencing, both published (gassner, transfusion, ; legler, trans. med., ; richard, transfusion, ) and in-house primers were used. results: repeated phenotyping of the sample with commercial as well as, in-house anti-d antibodies confirmed the rhd negativity. in addition, the adsorption-elution analysis showed a negative result. however, genotyping, using commercially available kits, yielded a rhd positive result and no variants were detected. to investigate this discrepancy, all rhd exons were sequenced. the sequencing data revealed the mutation c. + delt in the splice donor site of exon . to confirm the effect of the splice site mutation on transcription, rna from a fresh whole blood sample was analysed. as a positive control, gypb was amplified and sequenced from the same cdna. wild-type gypb (mns ) was found. with rhd specific primers, no product could be amplified. summary/conclusions: we present a serologically rhd negative case, that was identified as rhd positive by standard commercial genotyping kits. sequencing revealed the new splice site mutation c. + delt. rna sequencing yielded no detectable product. the donor was classified as rhd negative. this case of a discrepant result between serology and genetics shows the importance of a profound and highly sophisticated genetic investigation of conflicting laboratory results. j stettler, s lejon crottet, h hustinx, c von arx, f still, j graber, c niederhauser and c henny interregional blood transfusion src berne ltd., berne, switzerland background: one of the most immunogenic and clinically significant blood group antigens in transfusion medicine is the rhd antigen. variant rhd phenotypes with weakened or absent antigen expression pose a challenge for rhd status assignment in blood donors. to ensure patient safety, it is necessary to fully characterize these variants at the molecular level. aims: samples from two donors were investigated in our laboratory due to discrepancy in rhd typing. methods: rh blood group phenotyping was done by standard serological column agglutination testing (id-system, biorad). further rhd characterization was performed by an anti-d antibody panel containing monoclonal antibodies (d-screen, diagast) and an adsorption-elution test using an in-house pool of polyclonal anti-d antibodies. molecular investigation was initially performed by ssp-pcr detecting common rhd variants (rbc-ready gene cde inno-train; rh-type bag health care). rhd sequencing was done on either dna or rna using published and inhouse primers for amplification and sequencing. results: by tube testing, the rbcs of donor were predicted to be rh:- ,- ,- , , . however, all ten exons of the rhd gene could be detected by routine genotyping. sequencing of rhd revealed a homozygous mutation c>g at position which is the second last nucleotide of exon and thus might have an influence on exon splicing. by cdna analysis a transcript with a correctly spliced exon was identified. the mutation c. c>g leads to the amino acid substitution t r located in the twelfth transmembrane domain of rhd using the model of flegel (transfus apher sci., ) as reference. adsorption-elution testing using a pool of polyclonal anti-d showed a weak positive reaction, re-classifying the donor as rhd positive. this novel allele, rhd* g, could thus be categorized as a del allele. serological results displayed an almost normal rhd antigen expression for donor . further serological determination of the rhd antigen with different antisera, however, showed a reaction pattern typically observed with a weak d variant. with commercial available kits no rhd variant could be detected. rhd sequencing revealed a novel homozygous mutation c. g>c in exon . this mutation causes a p.a p exchange in the sixth membrane-spanning domain of rhd. based on serological data, the donor is rhd positive and in case of transfusion the patient would be treated as rhd negative. summary/conclusions: here we report two novel rhd missense mutations c. c>g and c. g>c harbouring an amino acid substitution within a transmembrane segment. the c. c>g variation displayed an unusual low rhd antigen reactivity and would have been mistyped as rhd negative without extensive genotypic testing. molecular analysis of variant c. c>g suggests that the t r exchange causes a del phenotype rather than a miss splicing event. this was also confirmed by adsorption-elution testing. interestingly, variant c. g>c could only be detected due to comprehensive serological and genetically investigation. background: the rh blood group system is highly polymorphic and one of the most clinically relevant systems in transfusion. actually d antigen is of critical importance due to its involvement in hemolytic transfusion reaction and hemolytic disease of the fetus and newborn. rhd gene variants are common in africans and mostly related to partial d phenotype. aims: rhd gene sequence was investigated in two african brazilian samples. we further attempted to take advantage of combining the molecular data and the available in silico tools for the functional interpretation of the variations, in order to get insights into the clinical phenotype that may be predicted a priori from genotyping. methods: sample #id is a d-negative donor self-declared as african descent. sample #id is a patient with sickle cell disease (scd) typed as d-positive with anti-d in his serum. serologic d typing was determined by manual gel test and by microplate in an automated instrument. sample #id was also submitted to adsorption/elution test. after genomic dna extraction, all ten rhd exons and flanking intronic regions from sample #id were pcr-amplified with rhd-specific primers and analyzed by sanger sequencing. sample #id was investigated by next-generation sequencing on the miniseq platform (illumina) by using a previously published, custom (selected blood group genes) ampliseq panel. a reported three-dimensional ( d) structural model of the rhd-rhd-rhag heterotrimer was used to visualize the position of variations and predict their putative functional/clinical effect. results: in sample #id , a single nucleotide missense change, i.e. c. c>g in exon , was identified. this transversion is thought to replace a threonine by an arginine residue at amino acid position (p.thr arg) of the rhd protein. analysis in the d model clearly suggests a dramatic impact of the p.thr arg substitution occurring in a functionally-critical, conserved motif in terms of interhelix interaction, which is supposed to be highly deleterious to the stability of the protein, and potentially impairs totally its expression at the red blood cell plasma membrane. this predicted functional effect is definitely in accordance with the d-negative phenotype reported in sample #id . in sample #id , the single c. a>g transition was found in exon leading to a threonine-to-alanine substitution at amino acid position (p.thr ala). amino acid is located in rhd protein extracellular loop , and is thus thought to alter d antigen structure, resulting in a partial d phenotype. this hypothesis is in accordance with anti-d found in the serum of sample #id . summary/conclusions: for the past years, due to the advent of next-generation sequencing and the subsequent identification of numerous rare variants, bioinformatics prediction and modelling tools have evolved and currently help physicians in diagnostics, clinical management and genetic counselling. we took advantage of some of those in silico methods to predict retrospectively the effect of two novel variant rhd alleles, including one d-negative and one partial d alleles. although phenotype and clinical symptoms remain definitely the standard determinants to assess the effect of genetic variations, use of those approaches may soon become valuable for guiding subsequent investigations in immunohaematology. abstract withdrawn. alleles of the weak d type and diva cluster. in africans, the most frequent were typically associated with alleles of the weak d type (including dol and rhdpsi), diva and dau clusters with f v occurring in > % of alleles; in addition the key mutations of weak d type and dii and two inactivating mutations (c. _ inst and c. delg) not reported in rhb were among the first polymorphisms. in east asians, rhd( g>a) at . % was most frequent, followed by dfv, weak d type , dbo- , key mutations of diva and weak d type cluster as well as rhce-like substitutions and the mutations of weak d type , type , type , rhd(a v), dvl- , weak d and rhd(n s). weak d type and rhd(t r) were frequent in south asia but not elsewhere. summary/conclusions: data from tgp and gnomad add relevantly to the knowledge on rhd alleles; tgd discloses linked intron polymorphisms, gnomad frequency data not biased by the likelihood of serologic detection. current typing strategies usually start with serology later complemented by molecular typing. in the future, molecular methods will gain importance and frequent alleles currently not distinguished from "standard rhd" may need a rational transfusion strategy. in this respect, the high frequency of weak d type and type in europeans was surprising, might warrant confirmation by alternative methods and should trigger discussion on rational transfusion strategies for these alleles. consistent with an r haplotype and probable dc-. two siblings that were abo compatible including the dc-sibling were incompatible at iat phase. reactivity could be completely adsorbed from the serum using r r , r r , and rr rbcs indicating the antibody is probably a single specificity. the donor returned in and to continue autologous donations. the aim of this case study was to examine the genetic framework of the rhd and rhce genes and to characterize the rh epitope recognized by the antibody. aims: the donor returned in and to continue autologous donations. the aim of this case study was to examine the genetic framework of the rhd and rhce genes and to characterize the rh epitope recognized by the antibody. methods: serologic testing was performed by manual tube testing using ahg in the indirect antiglobulin phase. rbc phenotyping was performed by standard tube hemagglutination testing from edta anticoagulated blood. rhd and rhce exons were sequenced using genomic dna and standard sanger dideoxy method with the bigdye terminator v . cycle sequencing kit. sequence data was aligned to rhd_ng_ . . rhd zygosity was performed using pcr-rflp with mspi. background: according to recent findings in molecular immuno-hematology, rhd genotyping is strongly indicated in rhc+ and rhe+ donors classified in routine as d-negative. among these, one could find a non-negligible share of entirely new genetic alterations or even del alleles, which are often not identifiable with routine serological methods due to the low number of antigenic sites. aims: the present study reports the genotyping data of rhd on rhc+ and rhe+ caucasian donors classified serologically as d-negative, all enrolled by a single transfusion center in italy methods: rhd serological typing was carried out in microplate direct agglutination tests (iris, immucor) by using different anti-d igm clones (clone , dvi+: ldm +esd m; clone , dvi-: rum- , th ) and different anti-d igg clones (clone : ms ; clone : d e ). all donors with d-negative results (n = , divided into subjects with rhc+, with rhe+ and with both rhc+ and rhe+) were addressed to genotype analysis with rhd beadchip molecular test (immucor), pcr-ssp (bagene, inno-train) and/or rbc-fluogene (inno-train). the discrepant results between serology (d-neg) and molecular biology (wild-type or full-length rhd gene) were further investigated by bi-directional sequencing of the rhd coding regions. results: one-hundred donors have been analyzed retrospectively, as part of a pilot study. following the data obtained in this first phase, the analysis methods described above have been implemented in routine, allowing to include further donors, studied prospectively. in . % of donors (n = ), the molecular analyses showed the complete deletion of the rhd locus, while in cases ( . %) a genetic status was found with "non-deleted" rhd. over all, bi-directional sequencing on these donors revealed the presence of negative and weak-d variants. the list of rhd alleles we have identified at the molecular level is as follows: rhd* n. ( cases), rhd* n. ( ), rhd* n. ( ), rhd* n. ( ) , rhd* n. ( ), rhd* el. ( ), rhd* el. ( ), rhd* el. ( ), rhd* w. ( ) . moreover we found a donor with a lack of signal encompassing exons - of the rhd sequence (bioarray rhd beadchip), while additional cases are currently under investigation. summary/conclusions: our study confirms that a non-negligible number of caucasian subjects, classified serologically as d-negative, present rhd gene alterations that differ from the common total deletion. in line with the literature data, we also found a frequency of about in cases ( subjects out of ), in which a donor re-classification as d-positive (weak d type) was necessary. hence, a wider use of molecular typing methods is desirable in order to achieve the correct genetic characterization and the appropriate phenotypic classification of "apparently" d-negative donors. background: without evidence of abnormal serological d antigen expression there will be no quest for weak d, partial d or d variant on the red blood cells. according to our blood donor registry we found that out of serologically typed donors, . % were d+, . % d-and . % weak d. aims: to compare different weak serological reactions of the d antigen to the rhd genotyping. methods: molecular rhd typing using isolated dna and rbc-ready gene cde and rbc-ready gene d weak kits was performed in blood donors, who were serologically typed as weak d using monoclonal blended igm/igg and dvi-and dvi+ anti-d reagents by slide and microplate (mp) technique respectfully, as well as by the antiglobulin test (iat) in gel and with the set of monoclonal partial d typing reagents (biorad). in addition, rhccee phenotyping and genotyping was also performed. results: all of the donors with serologically weak reactions were confirmed to be weak d variants by genotyping except one donor whose iat was false positive due to rbc autoantibodies. the frequency of d variant genotypes was as follows: % weak d type , % weak d type , one donor was typed as weak d type and another one as weak d type . these weak d types were associated with different degrees of serologically determined weakness ranging from negative to weak positive reactions concerning slide and mp. all of them gave positive reaction ranging from + to + with iat, except for the weak d type with the score of < + which gave negative reaction by slide and mp and inconclusive result with the set of monoclonal anti-d reagents for partial d typing. the percentage of donors, who, at serological typing were only found to be d positive in the iat was %. one of the weak d type donors was negative with dvi-and positive with dvi+ reagent in the mp. the additional rh phenotype (genotype) was ccee in all of the donors except in the one who was genotyped as weak d type , as well as in the d negative donor, being ccee. summary/conclusions: further rhd genotyping is required to estimate the actual frequency of d variants in our blood donors. in practice, current serological methods are sufficient to detect almost all variant d phenotypes. there is a consensus that routine molecular d antigen screening in d negative donors in order to detect del variant when ddccee phenotyped red blood cell transfusion is practiced in all d negative patients does not seem to be cost-effective. background: rh null or rh mod -the so-called rh-deficiency phenotypes-are characterized by a null or severely reduced rh antigen expression (including d, c/c and e/ e), respectively. molecular genetic studies showed that these phenotypes are transmitted in an autosomal recessive manner. rh null phenotype originates from two different molecular events giving rise to the amorph type and the regulator type. the former is caused by homozygosity for silent genes at rhd and rhce loci, caused by inactivating mutations in rhce and deletion of rhd. on the other hand, the regulator rh null type as well as the rh mod phenotype are attributed to mutations in rhag gene when in homozygous state or when in heterozygosity with another rhag allele containing an inactivating mutation. a functional rhag is essential both for the correct rh complex assembly and rh antigen expression in the erythrocyte membrane. aims: the aim of this study was to investigate the molecular genetic basis of an argentinean proband with no detectable d, c, c, e and e antigens by standard serological techniques. methods: blood samples were collected from the proband, her parents and sister. the proband was a year-old young woman with parameters of hemolytic anemia: low hemoglobin level ( g/dl), reticulocytosis ( %), hyperbilirubinemia, increased ldh and marked spherocytosis. the d, c, c, e and e status was determined by standard serologic hemagglutination techniques using specific monoclonal antibodies. genomic dna was isolated using a modified salting-out method. dna samples were initially screened for the presence of intron and the untranslated region of the rhd gene using pcr strategies. rhc/c, and rhe/e alleles were studied by allele-specific pcrs to determine the rhce genotype. rhd zygosity was analyzed by pcr-rflp. rhd exon polymorphisms were studied by rhd exon scanning procedure based on pcr-ssp. rhag gene was investigated by exon-specific pcr amplification and sanger sequencing. results: no d, c, c, e and e antigens were detected in the proband's erythrocytes. the father and sister rh phenotype was: d+, c+, c+, e+, e+ whereas the mother rh phenotype was: d+, c+, c-, e-, e+. rh genotyping confirmed the rh phenotypes for all family members except for the proposita who genotyped rhd+, rhc+ and rhe+. all samples showed an homozygous status for the rhd gene and all rhd exons were detected by exon scanning. sequencing analysis revealed an homozygous c. c>t mutation in rhag exon in the proband whereas the rest of the family showed an heterozygous state in the same nucleotide position. the c. c>t mutation is responsible for the p.ser phe amino acid substitution predicted to be in the th rhag glycoprotein transmembrane segment. summary/conclusions: this study described the molecular background responsible for an rh-deficiency phenotype in an argentinean proband. we identified the novel missense mutation c. c>t in the rhag gene which results in the ser to phe single amino acid substitution that shows to be critical for rh antigen complex assembly within the erythrocyte membrane. further studies are being performed in order to determine whether the proband is rh null or rh mod . background: rh blood group system is the most immunogenetic blood group system and blood donor typing should account for all expressing antigens in order to prevent anti-d alloimmunization. aims: the objective of this prospective study was to investigate rhd alleles among blood donors who typed d-by serologic methods and positive for c and/or e. for this reason we developed an easy-to-perform dna-based screening method for the detection of rhd gene and positive samples were further characterized by two commercial pcr-ssp kits. methods: of individual blood donors within a month period, ( . %) typed as d-with standardized immunohematologic methods including the indirect antiglobulin test (iat). residual edta-anticoagulated blood samples were used to isolate genomic dna using the qiaamp dna blood kit (qiagen, germany) from out of ( . %) c/e+ and serologically d-donors. all dna samples were tested individually for the presence of rhd-specific dna sequences in the rhd promoter, intron , exon and exon by a multiplex pcr-ssp method. the reaction was conducted in a final volume of ll with primers that were applied as described by f. wagner et al. (bmc genetics, ) except antisense primer for exon and the two primers amplifying an hgh gene fragment as internal control, designed by our laboratory. pcr products were visualized by electrophoresis on a % agarose gel with ethidium bromide staining. in case of a positive reaction the sample was analyzed by pcr-ssp d weak and pcr-ssp cde (inno-train, germany). results: out of d-individuals analyzed, were ddccee, ddccee, ddccee and one had a ddccee phenotype. molecular analysis showed that ( . %) were negative for all four rhd dna regions. among the other samples, all of ddccee phenotype, three were found to be positive for rhd promoter, intron , exon and exon , three for rhd promoter and exon , and two for exon alone. further genotyping revealed five hybrid rhd-ce-d alleles [ rhd-ce( - )-d and rhd-ce( - )-d], one allele represented the del(m i) genotype, while the remaining two samples did not show an allele that could be determined with the pcr-ssp kits. summary/conclusions: serotyping is the standard method to assign transfusion strategies but it is not always capable to correctly define all samples that show weak reactions in d. a rhd genotyping strategy is needed to confirm d-blood donors and thus to avoid anti-d immunizations. for these reasons we suggest the implementation of an easy and possible cost-effective method. background: more than weak d types have been described to date. transfusion recipients with weak d type , , or are not at risk for forming allo anti-d when exposed to conventional rh d-positive rbcs. molecular analysis of weak d offers a more reliable basis than serotyping to determine the prevalence of weak d types and optimal d transfusion strategies. background: the d antigen, which consists of a mosaic of epitopes, is determined in all the blood donors and patients. most people are either rhd-positive or rhdnegative, but there is a certain number of people who have a variation of the d antigen, which are called weak d, partial d and del phenotypes. aims: the objective is to use molecular methods to determine whether blood donors in republika srpska (with whom a serological weak d antigen has been detected) really have the weak d antigen. in addition, determine whether blood donors, who have been determined as persons who are rhd-negative, with the phenotypes c and/ or e, who have the rhd gene and d antigen on the erythrocyte membrane, so weak that it could not be determined by serological techniques. methods: blood samples were used from regular blood donors, who have been determined as persons with a weaker d antigen, as rhd-negative or as c and/or e positive (based on the agglutination strength) using serological techniques, the test tube method, the microplate method and the gel method. gp.mur was also modelled and shown to closely resemble the tertiary structure of glycophorin a. the predicted structure is anti-parallel b sheets arranged in a "b barrel" also referred to as an ob-like-fold. the regions in which blood group antigens were identified in the predicted stable dimeric structure. summary/conclusions: ob-like-fold structures typically to bind oligonucleotides or oligosaccharides and are associated with cold shock proteins. further modelling is in progress to predict the structure of gpa/gpb heterodimers as a basis for understanding the presentation of blood group antigens. of interest, this finding is consistent with a previous report showing that this gpa binds to carbohydrates. this model serves as a foundation for future work regarding the properties of gpa, which includes identifying locations of specific interactions between gpa and other rbc surface proteins such as gpb and band , as well as identifying structural features of antigenic regions on gpa. . even though no significant differences were found among the groups studied, haplotypes containing the mcc b and sl polymorphisms were identified in d samples but were not found in tb and l groups. summary/conclusions: this preliminary data obtained suggests that cr polymorphisms and haplotypes, especially those containing mcc b and sl snps, could be involved in the disease pathogenesis of tuberculosis and leprosy. the entrance of mycobacteria into macrophages is mediated by complement receptors that facilitate their uptake by host cells so the combined haplotypes could be enhancing parasite phagocytosis and inflammation. further studies are being carried out to establish whether cr polymorphisms are risk or protective factors and whether other genetic variations in this receptor are also involved. abstract withdrawn. background: the dombrock blood group system consists of two antithetical antigens, do a and do b , and three high-prevalence antigens, gregory (gy a ), holley (hy), and joseph (jo a ). the rare do null or gy(a-) phenotype lacks all dombrock antigens, and the do null alleles vary with both do* and do* backgrounds. here we report the molecular basis of a novel do null allele in a gy(a-) brazilian patient with anti-gy a . aims: case presentation: an alloantibody to a high-prevalence antigen was detected in the serum of a year old woman from the northeast brazil with a history of pregnancies but no history of previous transfusion. she required transfusion because of a schedule for total thyroidectomy surgery due to a large compressive nodular goiter. the antibody did not react with the autologous rbcs but reacted by the indirect antiglobulin test in liss with all panel rbcs and other rbc samples tested except with the gy(a-) phenotype. the corresponding antigen was resistant to treatment with papain but sensitive to dtt and trypsin. these results suggested that the antibody recognized an antigen in the dombrock blood group system. the purpose of this study was to identify the antibody specificity and to determine the molecular basis of the phenotype detected. methods: the red cells phenotype and the presence of the dombrock related antibody in the serum were detected by standard hemagglutination techniques. rbcs and antibodies were from our in-house collection of rare samples. genomic dna was prepared from peripheral blood of the patient. dombrock genotyping was performed by id-core xt platform (grifols, spain). the exons of the do gene were amplified by pcr and directly sequenced. experimental immunohematology and diagnostic immunohematology diagnostic immunohematology experimental immunohematology, sanquin, amsterdam, netherlands background: typing of blood group antigens is essential to prevent transfusion reactions or haemolytic disease of the foetus and newborn. to date, the isbt recognises blood group antigens. most antigens ( ) belong to one of the blood group systems. since the genetic basis of these systems is known, genotyping of these antigens is possible. the molecular background of antigens is unknown and can only be determined serologically. one of these antigens is sd a (sid), first reported in .~ % of the population carry sd a on erythrocytes, but this frequency might be higher since identification is difficult due to variability in expression. in % of individuals sd a is present in urine. cells with a high expression of sd a (cad/sda++) are used for detection of antibodies. recently, a -cells antibody detection panel of bio-rad contained a sda++ cell and many individuals with anti-sd a were detected. the b galnt gene has been implicated in the synthesis of sd a . we collected individuals with and without anti-sd a to elucidate the genetic background of the antigen. aims: elucidation of the genetic basis responsible for loss of the sd a antigen on red blood cells. methods: routine diagnostics to identify antibodies in patients was performed using a bio-rad -cells panel, containing donor with high expression of sd a . additionally, pregnant women were screened for anti-sd a . dna of eight samples with anti-sd a and eight samples without anti-sd a was isolated for further analysis. sanger sequencing was performed on b galtnt exon - . results: sequencing of b galtnt revealed two homozygous mutations which are present in all eight individuals with anti-sd a , but not present in controls. the remaining two controls are heterozygous for these mutations. the first mutation within exon , c. t>c (enst . , rs ) changes a cysteine to arginine at position of the protein. the second mutation in exon c. a>g (rs ) does not change an amino acid. both snps have a maf of . and therefore we expect that . % of the population is homozygous for the minor allele. genotyping of a large population of pregnant women and the serological detection of anti-sd a in women with a homozygous mutation is in progress. summary/conclusions: the high frequency antigen sd a has not been linked to a blood group system because the molecular basis for loss of the antigen has not been elucidated. the b galtnt gene has been associated with sd a synthesis and therefore we analysed this gene for mutations in individuals with antibodies against sd a . a single homozygous mutation within exon causing an amino acid change was found in all individuals with anti-sd a , and no individuals without antibodies were homozygous for this snp. from population studies we expected~ % sd a -negatives, but either this frequency is an overestimation because of difficulties to detect low expressed antigens or mutations in other genes are interfering with sd a synthesis. a larger study of individuals with homozygous mutations in b galnt and linkage to sd a -negativity and presence of antibodies will be performed before sd a can be assigned to a new blood group system. abstract withdrawn. abstract withdrawn. background: erythrocyte duffy blood group antigen can scavenge chemokines in whole blood. duffy blood group gene consists of two major alleles: fy*a and fy*b. however, little is known regarding the association of duffy blood group polymorphisms with the red blood cell (rbc) chemokine scavenging. aims: the aim of this study was to determine the association of duffy blood group polymorphism with the rbc chemokine scavenging. methods: the duffy blood group were genotyped by ˊ-nuclease assay in healthy chinese han individuals, while erythrocyte chemokine scavenging function and duffy antigen expression from the same samples were measured using erythrocyte chemokine binding assays and quantitative flow cytometry respectively. results: rbc chemokine scavenging of cxcl was significantly lower in the individuals with the fy*a/fy*a genotype compared to those with fy*a/fy*b genotype (p = . ). similar result was also observed in rbc chemokine scavenging of ccl (p = . ). the expression of duffy antigen on rbc surface in the individuals with the fy*a/fy*a genotype was significantly higher compared to those with fy*a/ fy*b genotype (p = . ). summary/conclusions: duffy blood group polymorphism is associated with the differential rbc chemokine scavenging. it is probable that a change in duffy antigen structure caused by duffy blood group polymorphism is responsible for the differential rbc chemokine scavenging. background: individuals with p-phenotype can develop a naturally occurring anti-pp pk and has clinical significance, causing hemolytic transfusion reactions or hemolytic disease of the fetus and newborn. finding and procuring blood units of pphenotype is a challenge because of its rarity throughout the world. therefore, acute normovolemic hemodilution (anh) can be an on hand tool in the perioperative successful management of patient with rare blood group. however, this approach has not been commonly used aims: n/a. methods: n/a. results: a -year-old korean woman was referred to samsung medical center for surgical management for gallbladder malignancy. her blood type was group a, d-positive. the patient had no known history of transfusion. however, antibody screening and identification test using the column agglutination method (bio-rad, cressier, switzerland) showed panagglutination with negative reactions to autologous red blood cells, indicating the presence of alloantibodies to high frequency antigens. the specimen obtained from the patient was sent to the central laboratory of the swiss red cross (bern, switzerland) and confirmed as anti-pp pk. at first, the transfusion team of our hospital recommended the surgical team to postpone the surgery. however, anh was planned because postponing surgery was not preferred and the patient's preoperative hemoglobin was . g/dl. ml of blood was withdrawn through a radial arterial catheter in two ml blood bags containing citrate-phosphate-dextrose-a solution after anesthetic induction. equal volume of % hydroxyethyl starch solution was infused during the procedure. the patient underwent radical cholecystectomy and liver wedge resection with lymph node dissection, and two units of autologous blood were returned to the patient during surgery. she was then discharged h later with a hemoglobin level of . g/dl. later, the family study was performed with the standard serologic method using the proband's plasma containing anti-pp pk and sequencing of the a galt gene, which were conducted according to the protocols by koda et al.(transfusion. ) . the proband and her brother were homozygous for c. dupc, indicating a rare p phenotype. summary/conclusions: we experienced that autologous blood transfusions via anh is an alternative to allogenic rbc blood transfusion in patients who have no blood available because of high alloimmunization antibodies against rare blood groups. " and the third sample as "gypb*s_gyp*[ a], gypb*s_null(ivs + t)" with a predicted phenotype: s-s+ mi a + and s+s-mi a +, respectively. the gypa specific primers used for discrepancy resolution detected the nucleotide substitution, gyp.c. c>a, in gypa-b-a hybrid associated to gp.hut allele, thus confirming the id core xt result. the expression of mi a for one of these samples was confirmed using non-commercial anti-sera. hence, these three samples were not gp.mur but gp.hut phenotype. both alleles codify for the expression of mi a antigen since it is expressed on several hybrids between the usual forms of glycophorin a and b. two of these three gp.hut samples are african-american donors. gp.hut was reported in white people with a frequency about . % and in thais with . %. these three gp.hut cases found by id core xt in this study point to a higher frequency of this glycophorin variant and also to the presence in african american population. summary/conclusions: id core xt was able to detect two glycophorin phenotypes, gp.mur and gp.hut, which codify for the expression of mi a antigen. standard molecular methods should be implemented in pre-transfusion testing and obstetrical care routine to detect the most clinically relevant glycophorin variants in mns system. background: serf(+) is a high prevalence antigen in the cromer blood group system, which is encoded by a crom* allele. the lack of the serf antigen, serf(À) on red cells is caused by a single nucleotide polymorphism, c. c>t in exon of the decay-accelerating factor, daf gene. alloanti-serf has been found in thai pregnant woman with serf(À) and a serf(À) individual was found among thai blood donors. anti-serf is not a marketed product; hence, a molecular technique has to be implemented to genotype for the crom* allele among blood donors. aims: this study aimed to identify the crom* allele among thai blood donors leading to predicted serf(+) and serf(À) phenotypes. methods: dna samples obtained from , central thai blood donors were genotyped for serf allele detection using in-house pcr with sequence-specific primer (pcr-ssp) and confirmed by dna sequencing. results: the allele frequencies of crom* (+) and crom* (À) among , central thais were . ( , / , ) and . ( / , ), respectively. the homozygous of crom* (À/À) alleles was not found in this study. additionally, the pcr-ssp technique was validated by dna sequencing using randomly chosen samples together with heterozygous crom* (+/À) samples and the results were in agreement. summary/conclusions: our results confirm a high frequency of the crom* (+) allele in the thai population and their frequencies were similar to those formerly reported among thai blood donors. this study would be beneficial to predict the serf antigen from genotyping results due to unavailability of commercial antiserum. background: there is increasing interest in the use of molecular methods for predicting abo grouping. though nextgen and sanger sequencing have both been used to predict abo type, predicting abo type from buccal swab-derived dna and from deceased donors benefits from a quick and reliable method. besides a pcr-rflp that has been used by many labs for more than years, there is a commercially-available research use only (ruo) kit, and both interrogate nucleotides associated with o , o , a and b with a representing the ancestral allele. aims: the aim of this report is to compare two low-resolution polymerase chain reaction (pcr)-based methods, for investigation of samples submitted to a reference molecular immunohematology laboratory for abo typing discrepancies. fifty-six peripheral blood samples were tested, from patients and from blood donors. methods: genomic dna was isolated from peripheral blood mononuclear cells. background: del is the weakest known d positive phenotype in the rh blood group system and detectable only by adsorption and elution tests. the rhd g>a change is an important marker for del phenotype in east asians. a rapid and efficient pcr method for rhd gene g>a genotyping is useful in east asian countries. aims: the aim of this study was to develop a method for rhd g>a genotyping by using single-tube pcr with melting temperature(t m )-shift primers. methods: two allele-specific primer for rhd g>a and a common primer were designed and synthesized. two gc-rich tails of different lengths were attached to ends of the allele-specific pcr primers. single-tube pcr with t m -shift primers was carried out with the three primers. after pcr, melting curve analysis was performed. rhd g>a could be genotyped by differences of the t m s of the pcr products. all of genotyping results were compared with those obtained from conventional pcr-ssp. for the discordant results, rhd exon sequencing was performed to determine rhd g>a genotype. results: a total of samples were genotyped for rhd g>a by pcr with t mshift primers. samples were typed as a+/g-, samples were typed as a-/g+, samples were typed as a+/g+ and samples were typed as a-/g-. two samples typed as a+/g+ by pcr-ssp but a+/g-by pcr with t m -shift primers were confirmed as a+/g-by rhd exon sequencing. summary/conclusions: the single-tube pcr with t m -shift primers for rhd g>a genotyping is simple, rapid, accurate, and it is superior to conventional pcr-ssp. abstract withdrawn. background: the rh blood group system has numerous variant alleles, which may affect rh antigen expression, including rhd-rhce (d-ce) hybrid genes. these variant alleles are frequently found in people of african descent, and typically result in either d-negative (d-) phenotype, or partial d antigen expression, including silencing of high-frequency antigens and/or expression of low-frequency antigens. patients carrying those alleles are particularly at risk of alloimmunization, suggesting that their identification is important in diagnostics. quantitative multiplex polymerase chain reaction (pcr) of short fluorescent fragments (qmpsf) has proven successful for genotyping those dna samples carrying d-ce hybrid genes by assessing both qualitatively and quantitatively rhd and rhce gene exons. aims: the aim of this project was to genotype both rh genes in a cohort of brazilian patients with sickle cell disease (scd), which are known to be of african descent, by using the qmpsf approach and report hybrid gene variability in this population. methods: one-hundred fifteen dna samples were selected for the study and analyzed prospectively by the rhd-qmpsf and rhce-qmpsf approaches to investigate the copy number of all exons in both rh genes. genotypes were further confirmed or investigated by sanger sequencing and conventional pcr-rflp assays. results: in the dna samples, ( . %) exhibited a "wild-type" profile by qmpsf analysis. hybrid genes involving exon , which is functionally not relevant as reported before, was found in samples, including and samples carrying respectively rhd-ce( )-d and rhce-d( )-ce (two homozygous each). except two samples that require additional studies ( . %), rhd zygosity was resolved successfully: (n = rhd gene copies; . %), ( ; . %) and ( ; . %). clinically relevant, i.e. partial d, genotypes were identified in four hemizygous samples ( / , . %) carrying rhd*dau , rhd*dv. , a rhd*diiia-like allele, and a novel rhd*d-ce( :g h-y s-n i)-d allele, as confirmed by sequencing. other hybrid alleles, such as rhd* n. and rhd*diiic, were also found in trans with a normal rhd* allele. in rhce, c/c genotype could be resolved. the rhce*ce (rhce*ce ( c)-d( )-ce) allele, which is commonly cis-associated with rhd*Ψ, was observed in four samples. however the clinically relevant polymorphisms in variant rhce alleles, such as those involved in cemo, cear, ceag, and ceti, were mostly identified by other standard methods. summary/conclusions: although most of the brazilian patients with scd investigated in this study did not carry rhd-rhce hybrid genes, qmpsf analysis has been shown to be an efficient tool in the whole genotyping process to investigate rh gene variation. as previously reported, it has been conclusive for characterization of rhd zygosity and identification of rare, as well as novel, variant alleles. additionally, our results show a large diversity of hybrid genes among the brazilian patients with scd. therefore, we suggest that qmpsf may be used as a complementary screening approach for assessing rh genotype in selected patients and donors. = ) vs. non-bleeding (n = ) patients. platelet, pmp and cp phenotype and function were evaluated by flow cytometry: activation and granule release were examined by antibodies against granulphysin (cd ), p-selectin (cd p), activated gpiib/iiia (pac- ) and phosphatidylserine (ps) (lactadherin) unstimulated and adp, trap or collagen stimulated. coated platelets were identified as a highly granulated independent cell population appearing following collagen stimulation, gated on side scatter and gpiba (cd b). normal healthy reference levels were available. results: the platelet count in bleeding ( /l) and non-bleeding ( /l) patients was comparable (p = , ). bleeding patients had a higher bat score compared to non-bleeding patients ( vs. , p < , ). the proportion of cps was normal in all patients. however, in non-bleeding patients the proportion of ps+cps and per cell ps expression (mfi) ( , % and , mfi) were higher, compared to bleeding patients ( , % and , mfi, both p < , ), and the proportion of ps+cps correlated negatively with bat score (r = , , p < , ). cd + cp was higher in non-bleeding ( , % and , mfi) compared to both bleeding patients ( , % and , mfi) and significantly higher than the reference level ( , % and , mfi, both p < , ). finally, the proportion of ps+pmps was normal in bleeding patients, but their pmps expressed higher than reference ps per cell, both unstimulated and for all agonist ( , mfi unstimulated vs , mfi reference, p < , ). summary/conclusions: patients with it exhibited different bleeding tendency despite comparable thrombocytopenia. in non-bleeding patients the proportion and per cell level of ps+ were higher, indicating that generation of cps with high ps expression is a critical factor determining bleeding phenotype. the finding of high pmp ps per cell level in bleeding patients could represent an inadequate compensation for lack of cp function, indicating that procoagulant pmps may be less important than cps for thrombocytopenic bleeding. quantification and characterization of cps may be a useful tool for future assessment of bleeding risk as well as a therapeutic target in it and other conditions with bleeding diathesis and/or thrombocytopenia. more studies investigating this field are warranted. background: alloantibodies against human platelet antigens (hpas) and human leukocyte antigen (hla) are implicated in several immune-mediated platelet disorders. detection of these antibodies is crucial in the diagnosis and management of these disorders. aims: to establish a method detecting hpa- , hpa- , hpa- , hpa- and hla antibodies using luminex bead technology. methods: monoclonal antibodies specific for platelet glycoproteins and hla class i molecules were separately coupled to the luminex microbeads. positive anti-hpa- a, anti-hpa- b, anti-hpa- a, anti-hpa- a samples were used to validate the specificities of the luminex assay. the anti-hpa- a, anti-hpa- a standard samples were used to evaluate the sensitivities of the luminex assay by serial dilutions (from neat to / ). results: samples collected from patients or isbt platelet workshop were tested by the luminex assay. the results showed that luminex assay could detect antibodies against hpa- a, hpa- b, hpa- a, or hpa- a successfully from the known samples. the sensitivities of the luminex assay detecting anti-hpa- a, and anti-hpa- a were : and : , respectively, using the standard samples. no cross-reactivity was observed in the samples containing multi-platelet antibodies, or mixture antibodies against hpa and hla. the results of samples with platelet disorders were agreement with those of monoclonal antibody immobilization of platelet antigens (maipa) assay. summary/conclusions: luminex beads coupled with monoclonal antibodies could be successfully used to detect hpa and hla antibodies with high sensitivity. background: platelet transfusion is important in clinical treatment. the expression of abo antigen on platelet surface is differential, so it is usually need to ensure the consistency of the abo antigen in clinical transfusion. but in many cases, it is difficult to find the platelets that the abo blood type matched between the recipient and donor, and abo-incompatible platelet infusion is required in these cases. to data, the expression of abo antigens on platelets in normal blood group individuals is rarely reported in chinese population. aims: to understand the differential expression of abo antigen on platelet surface in population of zhejiang province, china. methods: total of individuals with normal abo groups ( group a, group b and group ab individuals, and group o as negative control of abo antigens on platelets) were analyzed. the expression of abo antigens on platelets was determined by flow cytometry using monoclonal antibodies: fluorescein isothiocyanate (fitc)-conjugated mouse antihuman blood group a and pe-conjugated murine igg anti-b antibody ( pe bgrl ). flow cytometric parameters were statistically analyzed by the mann-whitney test or the kruskal-wallis test to observe the difference in two or more groups using graphpad software v . . the correlation and regression analysis between a and b antigen in the platelets and rbcs were also performed by the software. population studies were reported as the mean and standard deviation (sd), and p values less than . were considered statistically significant. results: according to mfi values of abo antigens expression on platelets, the samples were divided into three groups: low expression (le), high expression(he) and moderate expression (me) according to the background mfi observed in group o samples. it was found that about . % of the individuals had a weak expression of abo antigen on the platelet surface in zhejiang province. there was a significant difference in the intensity of antigen expression between these three different groups of the same blood group. for each blood group, there was a positive correlation between the intensity of abo antigen expressed on the platelet membrane and red blood cells of the individuals. results: cases were found with antibody positive. among them, cases ( %) were only anti-hla-i positive, cases ( %) were only anti-hpa positive, cases ( %) were both anti-hla-i and anti-hpa positive. cases were found without anti-hla-i or anti-hpa. among the cases with anti-hpa positive, the distributions of anti-gpiib/iiia, anti-gpia/iia, anti-gpib/ix, anti-gpiv were . %, . %, %, . %, respectively., hla antibody positive rate in the female patients was higher than that in the male and hpa antibody positive rate in the female was lower than that in male, but there was no significance difference between them (p > . ). summary/conclusions: in ptr patients, the platelet antibody was mainly hla-i antibody combined with hpa antibody. background: human neutrophil antigens (hna) are polymorphic structures located on surface membrane of human neutrophils. alloantibodies against hna are implicated in a number of clinical conditions, including immune-mediated neutropenia and transfusion reactions. genotyping for human neutrophil antigen (hna) systems is an important in the diagnosis of disorders involving alloimmunization to hna. aims: the aim of this study was to investigate the hna allele frequencies among blood donors and hematological patients undergoing blood transfusions and to estimate possible hna incompatibilities and risk of hna alloimmunization. methods: a total of blood donors and hematological patients from the north-west region of the russian federation were recruited. dna samples were obtained and typed for hna- , - , - and - systems using polymerase chain reactions with sequence-specific primers (pcr-ssp). specific primers for hna were designed and the polymerase chain reaction amplification conditions were optimized. the v test was used to test for the hardy-weinberg equilibrium for the hna systems. the probabilities of the incompatibility and the potential risk for alloimmunization against different hna systems after random transfusions were estimated based on the hna allele and genotype frequencies. results: in blood donors, the frequencies for the fcgr b* (hna- a), fcgr b* (hna- bd), and fcgr b* (hna- bc) alleles were . , . and . ; for the slc a * (hna- a) and slc a * (hna- b) alleles, . and . ; for the itgam* (hna- a) and itgam* (hna- b) alleles, . and . ; for the itgal* (hna- a) and itgal* (hna- b) alleles, . and . , respectively. in hematological patients, the gene frequencies for hna- a/ bd/bc, - a/ b, - a/ b, and - a/ b were . / . / . , . / . , . / . , and . / . , respectively. no statistic significant difference between genotypes in these groups was observed. since the allele frequencies of hna - , - - for hematological patients and donors did not have statistically significant differences, possible hna incompatibilities and risk of hna alloimmunization were estimated based on the obtained data on the allele and genotype frequencies of hna in a group that combines donors and hematological patients (n = ). the predicted risk of hna- , - , - , - incompatibilities in this cohort were . %, . %, %, and . %, respectively. the possible risk of hna- a, - bd, and - bc alloimmunization were . , . , and . , respectively; of hna- a and - b alloimmunization, . and . ; of hna- a and - b alloimmunization, . and . ; of hna- a and - b alloimmunization, . and . , respectively. summary/conclusions: the information about hna gene frequencies can be used not only in blood services for detection and identification of hna alloantibodies in donors and assessment of alloimmunization risk but also for anthropological studies. background: non-invasive fetal rhd genotyping is performed using circulating cell-free fetal dna from maternal plasma sample and real-time polymerase chain reaction. this antenatal routine dna test is used to target rh-ig administration to prevent hemolytic disease of the newborn. aims: the aim of this study is to characterize maternal rhd variants responsible for indeterminate results during fetal rhd genotyping due to early amplification of at least one of the exons ( , or ) of the rhd gene. methods: samples were tested from / / to / / using free dna fetal kit â rhd. samples ( , %) yielded a premature signal for one or more exons of the rhd gene. after extraction of maternal cellular dna, the maternal rhd was characterized using rhd beadchip assay (immucor/bioarray). rhdiiia-ce( - )-d summary/conclusions: greater diversity is observed in the caucasian population rather than in the afro-caribbean. % of the identified variants are rhd negative alleles including alleles leading to partial rh antigen expression. unexpected alleles are found such as weak d type , , or . these data underline the benefits of maternal rhd genotyping when abnormal early signals are detected during noninvasive fetal rhd genotyping. background: a considerable number of rhd alleles responsible for weak d phenotypes have been identified. serologic determination of these phenotypes is often doubtful and makes genetic analysis of rhd gene highly desirable in transfusion recipients and pregnant women. dna-based methods are useful for enhancing immunohematology typing in doubtful d phenotypes at pregnant women. aims: determination of the rhd gene in a cohort of pregnant women with doubtful d phenotypes. methods: determination of the rhd phenotyping was performed with microagglutination technique biorad and ortho diagnostic simultaneously. rhd genotyping was performed on cases with d typing serological discrepancies with ready-to-use inno-train rbc-ready gene cde and rbc-ready gene d weak test kits based on polymerase chain reaction with sequence-specific priming (pcr-ssp) to unclear serologic findings. results: molecular analyses showed of ( %) pregnant women were rhd*weak d type and not at risk for anti-d. rhd*weak d type were typed in cases ( %) and case was rhd*weak partial . and potentially at risk for being alloimmunized producing anti-d allo-antibodies. summary/conclusions: appropriate classification of rhd phenotypes is recommended for correct indication of rhig in pregnant women. however, the serologic differences between rhd-negative and rhd-positive pregnant women is a real problem for unnecessary application of rhig prophylaxis in pregnant women with d variants. conclusion: antenatal rhig prophylaxis is useful in rhd negative pregnant women. with genotyping we found that % of serological doubtful rhd negative women was d variants that not produce anti d antibodies. in that cases those rhig prophylaxis was unnecessary and harmful as a product of human origin. on other hand there is a save up of a stock of rhig which is any way in deficit. is it time to think about cost benefit of rhig prophylaxis and genotyping in pregnant women. background: in may , uk neqas (btlp) created an external quality assessment (eqa) sample designed to mimic a feto-maternal haemorrhage (fmh) bleed of ml. all material used passed pre-acceptance serological testing; samples were dispatched to participants in countries. post-dispatch testing by flow cytometry (fc) using an anti-d marker showed a bleed volume of . ml so an investigation was initiated. aims: to determine the cause of the unexpectedly low bleed volume and what lessons could be learnt. methods: production methodology and results of pre-acceptance testing were reviewed. fc testing was repeated, plots examined, and the fmh scientific advisory group consulted for advice. further fc testing was performed at wbs using alternative markers, and the material used was investigated at ibgrl. participant results were examined to determine if the sample should be withdrawn from scoring. a questionnaire on how results were managed was sent to the participants using fc with an anti-d marker. results: a material production methodology review showed no obvious cause of the erroneous in-house result. review of pre-acceptance testing images showed no issues, further d-typing of the cord showed + reactions vs. two reagents by tube, cf. + with two different reagents by column agglutination technology. repeat fc testing using the anti-d marker gave similar results; however, closer examination of the plots showed a left shift in the positive peak, indicating reduced fluorochrome binding, possibly due to reduced d antigen density on the cord cells. further fc testing at wbs demonstrated a marked reduction in fluorescence intensity with an anti-d marker. further investigation using an anti-hbf marker showed a bleed volume of . ml, indicating the correct proportion of cord material had been used during sample production. additional serology at ibgrl on the cord material showed reactions which were weaker than the control with / anti-d reagents. overall, the investigation supported the hypothesis that the cord material was d variant. a review of results submitted by participants mirrored the fc investigation and the sample was withdrawn from scoring, as the fc median result is used to calculate scores and the d variant cord was clearly affecting testing with an anti-d marker. the questionnaire showed that all respondents examine fc plots and the gating used, but not all act on them before reporting results, and not all have a back-up plan for anti-d ig dosing in a similar situation. later sequencing of the d gene revealed the cord donor to be dvii which can have a lower than normal d antigen density. summary/conclusions: the use of a d variant cord in an eqa sample was not planned, but allowed uk neqas to highlight some important learning points: -thorough examination of fc plots is essential to avoid underestimation of fmh; a controlled procedure should be in place if modification of gates is required -access to cord/neonatal blood to allow serological investigation may be useful in a similar clinical situation -it is important to have a back-up plan for issuing anti-d ig in the event of an uninterpretable fmh result background: allo-antibodies against fetal blood group and platelet antigens produced by antigen-negative pregnant women can cause hemolytic disease of fetus and newborn (hdfn) and fetal and neonatal alloimmune thrombocytopenia (fnait). prediction of the fetus antigen status in immunized women is important for making decisions concerning further management of pregnancy. nipt is widely used for determination of fetal blood groups but determination of proper specificity in the real-time amplification of a single nucleotide polymorphism (snp), such as k or hpa- a, requires modified protocols. droplet digital pcr (ddpcr) permits detection of low-grade fetal chimerism in maternal plasma dna with higher specificity using allelic discrimination pcr protocols. aims: to establish ddpcr protocols for non-invasive prenatal diagnostics (nipd) of clinically important blood group antigens. methods: dna was isolated from plasma samples of pregnant women and donors with known genotypes (easymag, biomerieux). allelic discrimination protocols for determination of k/k (n = ), s/s (n = ), hpa- a (n = ), hpa- (n = ), hpa- (n = ), hpa- (n = ) genotypes were performed using ddpcr method with droplet digital tm (biorad). the results of allelic discrimination performed using ddpcr were concordant with the already known phenotype/genotype of donors and pregnant women. ddpcr enabled the detection of - , reads for total dna from plasma in tested samples. all fetal results were in agreement with antigen positive genotype of the neonates and the fetal chimerism was from , % to , % (one case was for advanced pregnancy - week of gestation). in / tested samples false positive results were detected at the level of or unspecific reads. summary/conclusions: the implementation of allelic discrimination protocols for ddpcr allowed detection of fetal-maternal incompatibility in k/k, s/s and hpa- a, - a/b, - a/b, - a/b antigens encoded by snp. background: in france, for pregnancies complicated by anti-d (rh ) and anti-c (rh ) allo-immunization, the tests currently used to quantitate maternal antibodies are tube method titration and continuous flow analysis determination of the antibodies concentration. recently, an automated assay was developed using the column agglutination technology on the ih- system (bio-rad â). aims: we wanted to evaluate the score, calculated from the agglutination profile of the antibodies on the ih- system, as a quantitative data to appreciate the level of maternal antibodies. methods: titers from samples containing anti-d and containing anti-c have been established using the semi-automated tube method performed since decades in our lab and the fully automated gel method on the ih- system. scores were calculated manually in both cases. antibodies concentrations were also determined for all samples by continuous flow analysis on our auto-analyzer device (evolution iii ams alliance). we looked for a possible correlation between anti-d and anti-c scores and the corresponding concentrations using the spearman correlation test. results: anti-d tube and gel scores were significantly correlated with the anti-d concentration values (p < . , r = . and p < . , r = . respectively). anti-c scores were also significantly correlated with anti-c concentration values (p < . ) but gel scores have a better correlation coefficient than tube scores (r = . versus . ). it was easier to extrapolate gel score thresholds than tube score thresholds from the autoanalyzer values, with the aim of triggering fetal monitoring by ultrasounds and measurements of the peak systolic velocity in the middle cerebral artery only for risk pregnancies. the determined gel score thresholds were and , corresponding respectively to ui/ml ( uchp/ml) of anti-d and . ui/ml ( uchp/ml) of anti-c. conclusions: calculating the score from the hemagglutination profile displayed by the ih- system provides added values compared to the sole reading of the titer. for anti-c immunization, gel scores are more discriminant than tube ones and better correlated to the concentration values established by continuous flow analysis. the proposed score thresholds to trigger fetal antenatal monitoring need, however, to be confirmed on more samples and to be clinically documented. background: hdnf is due to maternal igg alloantibodies directed against fetal antigens that cross the placenta during pregnancy, causing hemolysis in the fetus, anemia that can lead to edema, ascites, hydrops and, in some cases, death. the diagnosis and management of hdnf is based on maternal screening, and middle cerebral artery (mca) doppler monitoring. in severe hdnf intrauterine blood transfusions (iuts) and or exchange transfusion (et) after birth are necessary to correct anemia, to prevent and treat fetal hydrops. aims: we report eight years of experience in our immunohematology reference laboratory (irl) to highlight the importance of red cell antibody detection as a fundamental parameter to identify pregnancies with high fetal risk and to drive a correct treatment. methods: we report laboratory data from pregnant women with a positive indirect antiglobulin test (iat) referred to our irl from january to december . we performed antibody screening and identification by indirect antiglobulin test (iat) in microcolumn method with biovue system (ortho-clinical diagnostics, raritan, usa), and the title of antibodies in iat by tube method without additive. follow-up tests were also performed in the presence of significant red cell antibodies in order to check antibody title and begin clinical monitoring. threshold values were ≥ : for anti kell antibodies and ≥ : for other specificities. results: out of women, ( . %) displayed clinically significant antibodies, ( . %) clinically insignificant antibodies and ( %) natural antibodies of different specificities. among women with clinically significant antibodies the most frequent was anti-d ( . %) also in combination with other rh antibodies ( . %), while anti-k accounted for %, anti-e for % and antibodies against high-incidence antigens for . %. anti-m and anti-le a antibodies were also found ( . % and % respectively) but they were not clinically significant. among women with clinically relevant antibodies, showed a critic antibody title and they underwent gynecological and obstetric monitoring. fetuses resulted affected by hdfn, displaying anti-d in cases and anti-kell in . fetuses with severe hdfn (anti-d in and anti-kell in ) required iuts, were treated with et, received red blood cells units at birth. summary/conclusions: the mother screening program led to important improvements in the outcomes of hdfn. the identification of women with clinically significant antibodies allowed an appropriate monitoring program and therapy. background: the hemolytic disease of the fetus and newborn (hdfn) is a severe disease, resulting from maternal erythrocyte alloantibodies directed against fetal erythrocytes. alloimmunization in pregnant women has been found to range from , % to , % worldwide. there are over erythrocyte surface antigens, of which more than have been reported to be associated with hdfn. although anti-rhesus d was once the major etiology of hdfn, the universal introduction of antenatal and postpartum rh immunoglobulin has resulted in a marked decrease in the prevalence of alloimmunization to the rhd antigen in pregnancy. consequently, alloantibodies other than anti-d emerged as an important cause of severe hdnf, in particular anti-k and anti-c. however, there are other antigens that have also been found to be associated with hdfn. aims: retrospective identification of erythrocyte antibodies in pregnant women in hospital de braga in and . methods: this study was planned to assess the prevalence of erythrocyte antibodies responsible for alloimmunization, excluding abo-immunizations, in pregnant women attending the antenatal clinics of hospital braga during years, from january to december . in this study, we retrospectively evaluated the erythrocyte antibody screening results of pregnant women. women with positive erythrocyte antibody screening also underwent identification with gel card system following the manufacturer's instructions (diamed â ). the outcomes of infants, whose mother's indirect antiglobulin tests were found to be positive, were examined. direct antiglobulin tests, jaundice and phototherapy history, transfusion and mortality of the newborns were recorded. results: during the study period, pregnant women were attended in hospital de braga. the laboratory registered positive erythrocyte antibody screening tests. the prevalence of positive erythrocyte antibody screening was , %. anti-d was the most common antibody found ( , %). anti-d prophylaxis given during pregnancy was responsible for of cases and maternal antibody titer levels did not exceed among these cases. the prevalence of non-rhd immunization was %. anti-e ( , %) was the most frequent alloantibody other than anti-d followed by anti-m ( , %) and anti-c ( , %). multiple maternal antibodies were found in pregnant women. four women had types of alloantibodies: anti-c and anti-e; anti-c and anti-d; anti-k and anti-cw; anti-e and a non-identified antibody. one pregnant had types of alloantibodies: anti-d, anti-c and anti-e. of all cases of newborns whose mothers had a positive antibody screen tests, icterus occurred in % of them and phototherapy was given in %. summary/conclusions: the prevalence of positive erythrocyte antibody screening in hospital de braga was , %. the erythrocyte antibody screening showed that anti-d was the most common antibody found ( , %) in most of the cases because of anti-d prophylaxis. the prevalence of non-rhd immunization was %. the other most frequent alloantibodies were anti-e ( , %), anti-m ( , %) and anti-c ( , %). an increasing prevalence of non-anti-d alloimmunization was found and there are currently no preventive strategies. in contrast to rhd alloimmunization, the main risk factor for non-anti-d alloimmunization is a previous transfusion therapy. thus, it is important to minimize the exposure of women to incompatible erythrocyte antigens through unnecessary transfusions when possible. background: the mns blood group system is one of the most complex blood group systems. although alloanti-m is a common antibody observed in pregnant women and could also be found in the serum of individuals who have not been exposed to m positive erythrocytes, it is rarely clinically significant and has been regarded as an unimportant antibody to cause hemolytic disease of the fetus and newborn (hdfn), especially in caucasian and black ethnic groups, for a long time. however, an increasing number of cases of severe hdfn resulting in fetal hydrops and recurrent abortion caused by alloanti-m have been reported mainly in the asian population, especially in the japanese and chinese populations. aims: to summarize the characters of serological testing in preterm twins newborns suffered with severe hdfn. methods: the blood sample of two newborns with severe hdfn and the mother, who had the history with three hydrops fetus, were collected. abo, rhd, rhce, and mn blood group typing of the twins newborn and their mother were performed in saline with tube or gel card. direct agglutination test (dat), elution test, antibody specificity identification and antibody titer detection were conducted by iat method in gel card. results: o, rhd(+), and ccee blood groups were identified both in the mother and the twins newborn. background: in france, since may , the legislation does not promote anymore the use of the reference tube method for titration of anti-red blood cells antibodies. this opened the way to the use of newly developed automated anti-red blood cells antibodies quantitation by column agglutination technology. aims: we wanted to assess the performance of titration and scoring by the id-gel test on the ih- system (bio-radâ) and to compare it with the performance established for the reference tube method, used in our lab since decades. another objective of the study was to determine titer thresholds for the gel method, to trigger fetal monitoring by ultrasounds and measurements of the peak systolic velocity in the middle cerebral artery. methods: an home-made internal quality control (iqc) prepared and calibrated using the international anti-d standard ( / ) was used to determine the intraassay and interassay imprecisions, regarding the score and the titer results. patients samples for testing were chosen during the -months assay period, regarding the specificity of the antibodies and the tube titer in order to cover a wide range of have lower values. the highest differences (more than to dilutions higher) were seen for antibodies directed against rh system antigens. among the other specificities, anti-k (kel ) and anti-m (mns ) antibodies show the most samples with equal or lower titers compared to the tube method. conclusions: automated anti-red blood cell antibodies titration by column agglutination technology on ih- system shows better intra and interassay cvs compared to the tube method. it is explained by the fully automated process that includes the reading step. titer results are almost always higher with the gel technology. thus, it seems possible to safely extrapolate the titer thresholds defined for anti-red blood cells antibodies by the tube method to the gel method. however, based on future clinical studies and fetal/neonatal outcomes, it would probably be necessary to increase these thresholds, at least for anti-rh antibodies, in order to avoid heavy, expensive, stressful and useless monitoring of some pregnancies. results: the first case was a -day-old female infant, yellowish skin developed the next day after birth. her capillary bilirubin level was mg/dl, the evidence favored neonatal hyperbilirubinemia and the clinical manifestation revealed hemolysis symptoms. her laboratory findings showed elevated reticulocytes ( . %), ldh ( iu/l) and g pd ( . u/ghb); dat (+/-), iat (-), anemia (hb . g/dl, hct %), and blood smear showed anisocytosis, spherocytes, and polychromatic rbc. her mother blood typed o, d positive, while her blood type was b, d positive and anti-b was found from her elution rbcs ( + ). due to rarely severe anemia with abo incompatibility, maternal plasma was analysed for abo igg antibodies and showed high antibody a and b titre with : and : . the female infant received one unit washed-prbcs for anemia and intensive phototherapy for hyperbilirubinemia. her clinical condition improved significantly, hb rose to . , bilirubin level was within normal range, she was discharged. another -days-old male infant was our second case. on the third day after birth, yellowish skin discoloration developed and bilirubin level was mg/dl. two days later, his transcutaneous bilirubin (tcb) measurement data was high and laboratory findings also showed raised reticulocytes ( . %), dat (+/À), iat (À), hb . background: anti-indian b is a rare alloantibody against the high frequency antigen in b . individuals with the in: ,- phenotype (in(a+b-)) are observed with a frequency of < . % in the indian population and have not been described in caucasians. the majority of anti-in b antibodies have been reported in individuals without previous transfusions, indicating the possibility of a naturally occurring antibody. anti-in b is considered clinically significant and haemolytic reactions after in b -incompatible transfusions have been reported. haemolytic disease of the foetus and newborn (hdfn) due to anti-in b has not been described. however, a positive direct antihuman globulin test (dat) may be observed. aims: to describe the challenges of managing a pregnancy and childbirth of a woman with an anti-in b . methods: serological investigations were performed by iat (tube and column agglutination). papain and trypsin treated cells were also utilised. soluble recombinant in blood group proteins (in-rbgp) (inno-train, germany) were used in neutralization tests. the clinical significance of the anti-in b antibody was determined by monocyte monolayer assay (mma). genomic dna was isolated from whole blood and the samples were further characterized by pcr amplification and sanger sequencing of exon of cd . results: in a -year-old pregnant (para ) woman of indian origin without previous transfusions, an alloantibody of the specificity anti-in b with a titer of : was detected by iat (negative with papain-treated cells) at gestational week (gw) and . the mma, performed in duplicate on samples taken at these dates, showed a mi of . %/ . % and . %/ . % respectively. the mi was interpreted as follows: - % not relevant; - % inconclusive; > % clinical significant. the patient's parents were typed heterozygous, in: , whereas her husband was homozygous, in:- , . due to the husbands phenotype, the fetus was predicted to be in b positive. doppler flow measurement of the peak systolic velocity in the middle cerebral artery of the foetus was normal. delivery took place at gw without increased bleeding. the neonate presented no clinical manifestation of hdfn. neither the mother nor the baby required blood transfusions. summary/conclusions: we report the case of a pregnant woman of indian origin with an anti-in b alloantibody. the first mma, performed in gw , was inconclusive whereas the second mma, performed in gw , indicated that the antibody was clinically significant. if the mi-increase is only due to the pregnancy or has also a clinical significance, cannot be stated. in b negative blood components were not available and the patient's relatives were all in b positive. therefore, measures to avoid transfusions, including optimised peripartal management of haemostasis, was of utmost importance. with only few cases published, the risk of hdfn could not be excluded with certainty. an intrauterine investigation by doppler was performed to exclude relevant anaemia of the fetus. no transfusion was needed at delivery as there were no haemorrhagic complications. the neonate presented no clinical signs of hdfn. background: hemolytic disease of the fetus and newborn (hdfn) is a disease which if untreatedcan cause perinatal mortality and morbidity with a substantial risk for long-term sequela. in albania we lack of studies in this field. aims: the aim of this study is to determine the predictive value and the reliability of the "critical titre" during the evaluation of red cells alloantibodies ability to cause the hemolytic disease of fetus and newborn. methods: we conducted a descriptive, cross-sectional study. the data were collected in the university hospital for obstetrics and gynecology in albania. in the study were included immunized pregnant woman for anti-d antibodies and their newborns which were affected from the hemolytic disease of fetus and newborn. the data belong to the period and . results: the "critical titre" in our study was , meaning that this was the minimal value of the titre antibodies that could cause hemolytic disease of fetus and newborn. our study concluded that only newborns were born without the hemolytic disease of fetus and newborn and the titre values were less than . moderate hemolytic disease of fetus and newborn were caused between the titre values - . the summary/conclusions: the titre values of the mothers are a predictive option of the high risk of giving birth to a child with the hemolytic disease of fetus and newborn. it is recommended that in this cases the mother should be followed with doppler ultrasonography to measure the blood flow of the middle cerebral artery. also the doctors should recommend in pregnant women with positive coombs test not only the identification of the anti-d antibodies but also the identification of the other antibodies such as anti-e, anti-c, anti-k. background: rhd-negative pregnant women with allo-anti-d are at risk of having a fetus affected by haemolytic disease of the fetus and newborn (hdfn) where the fetus is rhd-positive. the rhd allele is highly polymorphic and many rhd variants give rise to an array of partial d phenotypes. the clinical significance for many partial d phenotypes is not well-established. rhd genotyping by non-invasive prenatal testing (nipt) to assess the fetal rhd status determines whether the fetus is at risk for hdfn. nipt tests also include strategies for detecting maternal rhd variants to provide for accurate reporting. however, the presence of a paternal rhd variant, while having the potential to confound nipt interpretation, is often not recognised. we report a "trio" family study triggered by a request for nipt for an rhd-negative pregnant mother, weeks gestation, who presented with allo-anti-d and anti-jk a antibody. subsequent paternal and fetal rhd genotyping was conducted and revealed a novel variant rhd allele. aims: we aim to characterise the paternal rhd allele and review clinical case features. methods: rh phenotyping was performed by standard serological procedures. nipt tested for fetal rhd exons , and . rhd genotyping on whole blood/cord blood dna was performed on the immucor bioarray rhd beadchip kit which predicts a rhd phenotypic variant of best fit. dna sequencing was performed using the illumina trusight one sequencing panel. copy number variation (cnv) analysis was used to assess the rhd exon structure and zygosity. results: the paternal red cells typed as group o rhd+c-c+e-e+, (ror). nipt genotyping detected fetal rhd signals for all exons, predicting rhd-positive. no maternal rhd sequences were detected consistent with homozygosity for the rhd deleted haplotype. for both paternal and cord genomic dna (gdna), beadchip genotyping predicted a rhd variant "diiia/cehar". furthermore, signal drop out was observed at nucleotide positions (c. , c. , c. ) located in rhd exon suggesting exon was either deleted or rhce-replaced. paternal and cord gdna sequencing detected out of snps (c. g>t, c. c>t, c. a>c, c. c>g) associated with diiia phenotype plus additional snps (c. g>a, c. g>c) on the rhd gene. both were rhd hemizygote by cnv analysis. no rhce variants were detected. clinical case features: the maternal anti-d quantitation increased from . iu/ml ( weeks gestation) to iu/ml ( weeks gestation). the fetus required intrauterine transfusions during the pregnancy to manage the hdfn. summary/conclusions: both father and fetus carry an rhd allele that does not align with alleles encoding diii phenotypes. this putative novel rhd variant allele comprises snps associated with diiia and with a possible exon deletion/rhcereplaced. a similar allele was reported in literature, although based on sequence analysis only, with no phenotype data. the variant allele here encodes rhd-positive phenotype and we predict that there may be a loss of d-epitopes. notwithstanding, the clinical presentation shows that maternal anti-d against this rhd phenotype (presumed partial) is associated with a severe hdfn and that such rhd blood group phenotypes are of clinical significance for alloimmunised pregnancies. abstract withdrawn. background: cd is a glycosylphosphatidylinositol (gpi)-anchored protein with apparent molecular mass of kda. in addition to being expressed on human plts, cd is expressed on activated t-cells, endothelial cells, cd + hematopoietic stem cells as well as on progenitor cells. in the chinese population, the calculated allele frequencies of hpa- a and - b are . and . , respectively. based on these data, the risk of alloimmunization against hpa- alloantibodies due to incompatible plt transfusion or pregnancy is expected to occur in relatively high frequency. however, until today there is no report of hpa- alloimmunization in the chinese population. in this study, we analyzed sera from hydrop fetus cases by maipa technique and icfa. aims: to detect the anti-hpa b alloantibodies by maipa and icfa. methods: a -year-old mother, gravida /para . the mother in the first pregnancy was diagnosed hydrop fetus at pregnancy weeks by ultrasound. in the second pregnancy, fetal hydrops was observed by ultrasound at pregnancy weeks. the mother's irregular antibody test was negative. the maternal platelet specific antibodies and hla antibodies were negative. blood routine and morphological examination of fetal umbilical cord blood showed that plt count dropped to . /l, wbc count dropped to . /l, including neutrophil %, lymphocyte %, mononuclear %, eosinophil %, basophil %, red blood cells were normal, hb was g/l. screening for hla and plt-specific antibodies was performed using a elisa-based plt antibody kit (pakplus, gti diagnostics) as recommended by the manufacturer. plt antibodies were detected by icfa and maipa.hpa genotyping was detected by cpr-ssp. results: the fetus's genotype was hpa- a/a, - a/a, - a/a, - a/a. - a/a, a/a, a/a, a/b, naka (+) and the maternal was hpa- a/a, - a/b, - a/a, - a/a. - a/a, a/a, a/ a, a/a, naka (+). the paternal genotype was hpa- a/a, a/b, a/a, a/a, a/a, a/a, a/a, a/b, naka (+), which was the only incompatible antigen compared with the maternal hpa. samples were tested using the fresh plt panels consisting of hpa- aa and - bb homozygous donors. the reactivity of the negative control and the mother's sera with the plts from hpa- a/a (donors ), hpa- a/b (donors ) and hpa- b/b (donors ) donors by maipa. the mother's serum showed no reactivity against a/a plts, weak positive reactivity against a/b plts (od values . ), but strong reactivity against b/b plts (od values . ).this finding could be confirmed by one of the reference plt laboratories (japanese red cross kanto-koshinetsu block blood center, japan) using freshly isolated plts from hpa- genotyped donors (anti-hpa- b average value . ). summary/conclusions: in this study, we found anti-hpa- b in a case of fnait (patient hpa- aa, blood group o) using the maipa technique. we were able to detect the presence of hpa- b alloantibody in one case of nait. background: fetal and neonatal alloimmune thrombocytopenia (fnait) occurs in : live births in caucasians. serological and molecular human platelet antigens (hpa) genotyping tests are performed to investigate and conclude to fnait diagnosis. however, in few cases and particularly in case of suspicion of private platelet antigen, some specialized analyzes must be performed in the laboratory (lab). these analyzes can range from sanger or ngs sequencing to platelet serology with transfected cells. aims: the aim of our study was to explore where the frontier between research and care takes place in the field of platelet immunology through the prism of the fnait investigations carried out by the platelet immunology laboratories. methods: a two-part electronic survey have been sent to foreign platelet immunology experts (pie) from platelet immunobiology working party (piwp) members and espgi board members (n = ). the first part focused on the lab practices and regulatory environment regarding to accreditation, contact with patient, informed consent and patient results. the second part stressed on the investigations performed to discover new platelet antigen and more precisely on the perceived status of these analyzes ( background: haemolytic disease of the fetus and newborn (hdfn) can occur when maternal red cell antibodies, directed against red cell antigens present on the fetal red blood cells, cross the placenta and enter the fetal circulation. in a "traditionally" conceived pregnancy, when hdfn occurs, it is as a result of maternal antibodies directed against fetal red cell antigens in the heterozygous state, whereby the antigen is inherited from the father only. with the advent of donor oocyte (do) in-vitro fertilisation (ivf), the addition of a third person into the reproductive equation allows for the possibility of a more severe form of hdfn when fetal red cell antigens are present in the homozygous state (one copy from father and one copy from donor) and maternal antibodies are directed against these. antigens expressed in the homozygous state will have more antigens sites per red blood cell and therefore are at an increased risk of red cell destruction from the maternal derived cognate antibodies. aims: to raise awareness of increased severity risk of hdfn in donor oocyte conceived pregnancies. methods: we describe two unusual cases of hdfn in our institution of two women whose pregnancy was induced using a donor oocyte and their offspring requiring transfusion support in the postnatal period to treat hdfn. results: the first is a case previously reported (doyle, quigley, fitzgerald et. al. transfusion medicine, ) of protracted hdfn due to anti-c, managed with phototherapy initially, then intervention with red cell top-up transfusion at weeks post-delivery. the second is an unusual case of severe abo hdfn requiring exchange transfusion therapy (pre-publication). summary/conclusions: given the increased number of pregnancies conceived using do we recommend that antenatal guidelines are reviewed to create awareness regarding the potential increased risk of hdfn in do pregnancies complicated by allo-immunisation. critically, antenatal testing guidelines should highlight that the predicted outcomes associated with quantitation/titres can only be used when do has not been used to obtain the pregnancy. it is also essential that clinicians inform the blood transfusion laboratory when do has been used. abstract withdrawn. %) are deceased due to organ rejection, and / patients ( %) are deceased due to disease not related to rejection. summary/conclusions: the use of therapeutic plasma exchange for the treatment of antibody mediated rejection in solid organ transplant is safe and effective when used along with other treatment modalities. further studies will help determine whether it can be reproduced in larger cohorts and whether it is more effective in certain organs. background: extracorporeal photopheresis (ecp) is an important cellular therapy for the treatment of several (auto-)immune diseases such as graft-versus-host disease. the international standard for the ex vivo treatment of the leukapheresis product is the application of -methoxypsoralen ( -mop) and irradiation with uv-a light. however, the addition of -mop to the illumination bag is associated with a potential risk of contamination. aims: the basic principle of the ecp is the induction of apoptosis in the leukocytes. our aim was to find an alternative for the conventional apoptosis induction without the need of external substance application. the objective of the study was the investigation of the apoptosis levels and kinetics in leukocytes after treatment with -mop+uv-a compared to uv-c treatment without additional -mop. methods: we used an in vitro h cell culture approach with human mononuclear cells from healthy blood donors. untreated control cells were compared with , lg/ ml -mop plus j/cm uv-a treated cells and j/cm (effective dose) uv-c treated cells. apoptosis in several leukocyte sub-populations was detected daily with annexin v and -aad flow cytometry standings. results: the apoptosis analysis of cd cd t-helper cells, cd cd cytotoxic tcells, cd b-cells, cd monocytes, cd neg cd nk-cells and cd cd nkt cells revealed no statistical differences in almost all of these cell types after treatment with -mop/uv-a or uv-c light. the apoptosis kinetic as well as the final apoptosis after h were similar in both treatment groups. summary/conclusions: the addition of -mop to the photopheresis irradiation bag is a risk for potential infections. the main effect of the -mop/uv-a treatment is most probably the induction of apoptosis in the leukocytes. here, we provide information that this induction of apoptosis can also be achieved with uv-c irradiation without the need of -mop addition. the apoptosis patterns in most leukocyte subpopulations are very similar after treatment with uv-c compared with -mop/uv-a treatment. future in vivo studies are needed to prove the therapeutic effect of uv-c treated cells in the ecp setting. abstract withdrawn. background: therapeutic plasma exchange (tpe) is performed to remove the implicating substances from the plasma causing the disease. a periodic appraisal of tpe data is important to get insight into the procedural related effects and toxicities and overall outcome in order to have a guided future approach. aims: the purpose of this study is to observe the overall profile and outcome of the patients receiving the tpe in the medicine intensive care unit (micu) of a tertiary care hospital in south india. methods: a record based audit was conducted for the all the patients who were admitted to our tertiary care hospital of south india with bedded micu and received tpe therapy between june, and december . all the tpe procedures were performed using haemonetics multicomponents system (mcs) + ln apheresis system based on intermittent flow centrifugation. we audited our tpe for: number of treatments, clinical indications, treatments prescribed and administered, any procedural or patient complications, and adherence to current best practice recommendations. results: sixty nine patients had undergone tpe procedures. among them, thirty were female patients ( %). the median age ( - ) years. guillain-barre syndrome (gbs) was the most common indication ( %) followed by cases of thrombotic thrombocytopenic purpura, diffuse alveolar hemorrhage, myasthenia gravis, autoimmune encephalitis and hypertriglyceridemia respectively. the tpe regimens received by patients in this icu were not always prescribed in accordance with current best practice recommendations. there were ( %) episodes of patient related complications during the tpe treatments. in ( %) procedures, technical error in the machine was encountered. summary/conclusions: the findings of this audit have identified differences between the current prescription recommendations for tpe and those applied. the infrequency of the therapy and the different indications may present a challenge for medicine intensive care clinicians to provide best care in all cases. background: microangiopathic hemolytic anaemia (maha) encompasses a spectrum of disorders characterised by widely disseminated thrombosis in small blood vessels resulting in formation of schistocytes and concomitant thrombocytopenia. plasma exchange (pe) needs to be considered as empirical and urgent life saving therapy in these disorders irrespective of waiting for specific testing like adamts levels in thrombotic thrombocytopenic purpura (ttp) or complement levels or factor h antibodies in atypical hemolytic uremic syndrome (ahus). aims: to assess the efficacy and safety of plasma exchange in patients diagnosed as having microangiopathic hemolytic anaemias. methods: a retrospective analysis of all pe procedures performed in patients diagnosed as having maha was done over a period of years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . procedures were done on apheretic device (cobe spectra, terumo bct, lakewood co. usa). patients' pre and post procedural hematological and renal parameters were analyzed by applying paired t test. adverse event if any was recorded. results: pe was performed in patients with diagnosis of maha ( -ahus, -ttp, each of post stem cell transplantation drug induced thrombotic microangiopathy (tma), post thyroidectomy tma and post-partum tma). the mean age of patient was . ae . years with m:f as . : . number of procedures per patient varied from to . post pe recovery was observed within - days with statistically significant increase in mean platelet count from . ae . to . ae . /l (p = . ) and significant decline in mean lactate dehydrogenase level from . ae . to . ae . lkat/l (p = . ). there was also significant decline in mean percentage of schistocytes in peripheral smear from . ae . % to . ae . % (p = . ). the mean serum urea changed from . ae . to . ae . mmol/l and creatinine from . ae . to . ae . lmol/l (p = . and . respectively) with significant increase in urine output from . ae . to . ae . ml/kg/h (p = . ). adverse events were observed in patients ( %), allergic reaction to replacement fluid (n = ) being the commonest followed by hypotension (n = ), rigors and chills (n = ). overall survival rate at months was %. summary/conclusions: pe had proven its safety and usefulness as life-saving first line treatment modality in maha. prompt and aggressive treatment helps in achieving early and complete remission in these patients. background: neuromyelitis optica (nmo) also known as devic's disease or devic's syndrome is a rare demyelinating disease of the central nervous system that most often results in selective involvement of the optic nerves (optic neuritis) and spinal cord (myelitis)and has female preponderance. neuromyelitis optica (nmo) attacks are poorly controlled by steroids and evolve in stepwise neurological impairments. assuming the strong humoral response underlying nmo attacks, therapeutic plasma exchange is an appropriate technique in severe nmo attacks. aims: to study the effect of tpe in neuromyelitis optica. methods: a year old female in the medicine department, civil hospital, ahmedabad admitted with chief complains of weakness and numbness in the arms and legs, blurred vision, reduced sensation, difficulty in controlling bladder and bowels, uncontrollable vomiting and hiccups since - days in the medicine department, civil hospital, ahmedabad. attacks were treated with short courses of high doses of intravenous corticosteroid -methylprednisolone intravenous. but there was no clinical improvement. results: clinician advised for the trial of tpe in this patient. the procedure was performed by automated device with continuous flow centrifuge machine fresenius kabi-com.tec using double lumen femoral catheter. after obtaining informed consent from the relative of the patient, cycles of tpe were performed on daily basis. after cycles, both subjective and objective clinical response to tpe was estimated by three different sources (the patient, a transfusion medicine physician, and the treating neurologist). [ ] for motor performance, patient was assessed on a disability scale ( = healthy; = minor symptoms; = able to walk meters without support; = able to walk meters with support; = confined to bed or wheelchair; = requiring assisted ventilation; = dead).patient's motor performance was increased to scale (upper limb) and (lower limb) from scale , deep tendon reflexes were normal. visual function began to improve week after the treatment. visual acuity was / after weeks. summary/conclusions: assuming the strong humoral response underlying nmo attacks, therapeutic plasma exchange is an appropriate technique in severe nmo attacks. this suggests that tpe is beneficial in nmo patients during acute attack if there is no response to corticosteroid treatment. background: babesiosis is a tick borne infectious disease caused by the protozoa babesia. while most infections with babesia are asymptomatic, some patients present with a symptomatic infections and rarely this can be a severe life threatening illness. treatment is primarily with antibiotics but red cell exchange (rce) has been used in the more severe cases which are characterized by high grade parasitemia, evidence of severe hemolysis and or multi-organ failure involving the kidney, lung or liver. a threshold parasite level of % has arbitrarily been applied as an indication for rce, however, this threshold is not evidence based. aims: to report on patients with babesiosis and high grade parasitemia who were treated with antibiotics only without rce methods: data were collected from july to july . a case was defined as a patient diagnosed with babesiosis for whom rce was requested on the basis of a parasitemia of > % but on clinical evaluation it was considered that rce could be withheld and the patient monitored awaiting response to antibiotics. results: three cases of severe babesiosis in which the use of rce was requested on the basis of a parasite level of greater than %, but was not performed. the rce was deferred on account of the good clinical state of the patient and the absence of renal failure. levels of parasite at diagnosis were . %, % and %. all patients were followed daily until discharge. two of these patients had been splenectomized and each received a single unit of red blood cells during the hospitalization. the third patient had a long history of refractory lymphoma and was pancytopenic requiring multiple transfusions during the years before the diagnosis of babesiosis. she had transfusion transmitted babesiosis from a red blood cell transfused days prior to the diagnosis. all three patients responded well to antibiotics and were discharged between - days with undetectable parasites. summary/conclusions: this small case series suggests that requests for rce solely on the basis of an arbitrary level of parasitemia should be questioned and the clinical state and evidence of organ failure considered in the decision to perform rce. abstract withdrawn. chronic transfusion program (ctp) remains the gold standard therapy for stroke prevention and for patients with a severe disease who have inadequate response to hydroxyurea treatment. aims: to evaluate the safety, efficacy and cost between scd patients on ctp that underwent both aet and partial manual exchange transfusion (pmet) procedures. methods: retrospective observational cohort study of patients with scd on ctp that have switched between pmet and aet. this study was carried out from / / to / / in a hospital in portugal. data on patient history, haematological values, duration of the procedure, intervals between them, adverse events as well as the cost of material and working hours were collected and compared between both procedures. results: a total of patients met the inclusion criteria described. however, patient was excluded from our study because of the lack of attendance to the ctp. during the study, we recorded exchange procedures ( pmet and aet), both on peripheral venous access. from all those procedures the major concern was the poor venous access, which was the reason why patients had returned to pmet. no major complication or alloimmunization was observed. the indications for ctp were cerebral vasculopathy (n = ), stroke (n = ) and recurrent vaso-occlusive crisis with multiorgan failure (n = ). for both procedures, target values were to obtain a pre-exchange hbs level ≤ % for stroke and cerebral vasculopathy and ≤ - % for other indications. the median hbs level before pmet was , % ( , - , ) and , % ( , ) before aet. we documented a higher hbs level prior to the next procedure in , % of patients (n = ). despite that all patients remained stable without any major scd related event. both procedures were well tolerated and iron overload was well controlled (median ferritin level pmet: , vs. aet: , ng/ml). the duration of the exchange procedure was longer and the intervals between procedures were shorter with pmet (median pmet: vs. aet: min and pmet: vs. aet: weeks, respectively). annual rbc requirements per procedure were superior (median vs. units) and the overall costs related with aet were , times higher - . , € and . , € aet and pmet, respectively (estimated cost per session aet: , € and pmet: , €). summary/conclusions: our study shows, that the hbs level before both procedures, performed during the same interval, was similar. we verified that pmet has a comparable efficacy with aet in terms of preventing the development or progression of chronic complications and that the cost per procedure is significantly higher with aet. however, in a clinical situation where it is important to rapidly reduce the hbs level, and/or where the control of the target hbs is stricter so that the patients are clinically controlled without an increase in hospital visits, aet is preferred. we conclude that aet is more effective in the rapid reduction of hbs and ferritin levels, as well as being less time consuming. despite this, for the reasons described above, it is more cost-effective to maintain both aet and pmet procedures. background: erythrocytapheresis/red blood cell (rbc) exchange, involves removing of a large number of rbcs from the patient and returning the patient's plasma and platelets along with compatible allogenic donor rbcs. typical indication for rbc exchange is sickle cell disease and its related complications. however, one of the miscellaneous indications of rbc exchange is for the patients of methemoglobinemia who are refractory to treatment by methylene blue. acquired methemoglobinemia is more common than any genetic causes. acquired methemoglobinemia is caused by toxins that oxidize heme iron, notably nitrate and nitrite-containing compounds. for patients failing to respond to standard treatment with methylene blue or in whom its use is contraindicated; hyperbaric oxygen or rbc exchange is indicated aims: case reports on use of rbc exchange in methemoglobinemia are few and indications are based on anecdotal reports. methods: exchange was performed on the cell separator machine, com tec by fresenius kabi. results: we report a case of acquired methemoglobinemia where patient was admitted with peripheral capillary oxygen saturation (spo ) of % on air. the patient did not show improvement in spo level with effective emergency treatment of methylene blue. since, the patient was refractory to treatment with methylene blue, the decision was made by clinician to proceed with rbc exchange. the patient improved significantly after two cycles of one rbc volume automated rbc exchange, and was discharged with spo of % on air. summary/conclusions: automated rbc exchange can be used in patients of acquired methemoglobinemia successfully when methylene blue is ineffective, and may be superior to manual one. background: therapeutic plasma exchange (tpe) is known to disturb the ph and electrolyte status. patients with compromised liver functions may be at a higher risk of electrolyte imbalance due to metabolic abnormalities. aims: the aim of this study was to analyze the variation in ph, ionized calcium, sodium, potassium, and bicarbonate in liver disease patients undergoing tpe. methods: patients with liver disease undergoing tpe during the period from july to august were included in the study. data on patient demographics, details of the tpe procedure, blood gas analysis report and adverse effects of tpe (if any) were collected and analyzed. results: one hundred and seven procedures were done during the study period; of these ( %) were done on the mcs plus (haemonetics corporation) and rest ( %) were done on the spectra optia (terumo bct). the percentage change in ionized calcium, sodium, and potassium due to the procedure was found to be statistically significant (p = . ). the systolic (p = . ) and diastolic ( . ) blood pressure also changed significantly with the procedure. the predictors for the change in ionized calcium were found to be pre-procedure ionized calcium (p < . ), the age of the patient (p < . ) and the pre-procedure ph (p = . ). procedurerelated complications occurred during procedures of which complications ( . %) were categorized as features of hypocalcemia. no association was found between hypocalcemic manifestations and pre-procedure calcium, change in calcium, age or gender of the patient. summary/conclusions: the tpe procedure in liver disease patients causes remarkable changes in ionized calcium, sodium, potassium and bicarbonate ions. the decrease in ionized calcium during the procedure is predicted by pre-procedure ionized calcium levels, ph and age of the patient. monitoring of these parameters and appropriate corrective measures are imperative to patient safety. background: therapeutic plasma exchange (tpe) in pediatric age group is technically demanding because of low blood volume, difficult venous access and poor cooperation of the patient during the procedure. we here present our experience of tpe in pediatric patients from our centre. aims: to assess the challenges during tpe in pediatric patients and formulate appropriate strategies. methods: we did retrospective analysis of all tpe procedures performed in pediatric patients over a period of years ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . tpe procedures were done on two different apheretic devices (cs plus, fenwal usa and cobe spectra, terumo bct lakewood, colorado) daily or on alternate days depending on clinical condition of the patient. for all procedures, kit was primed with compatible packed red cells. adverse events during the procedure were noted and analyzed. results: a total of tpe (range - /patient with mean of . procedures) were performed for pediatric patients with different indications like atypical hus (category i as per american society for apheresis (asfa) in total patients, neuromyelitis optica (category ii) in patients, rapid proliferative glomerulonephritis (category i), c glomerulopathy in patients each and one patient of infective hemophagocytosis. the average age of patient population was . yrs ( . - years) . the male:female ratio was : with an average weight of . kgs. adverse events were observed during ( . %) procedures. most commonly observed adverse events were allergic reaction to replacement fluid ( . %) followed by hypotension ( . %), line occlusion ( . %), vasovagal, endotracheal tube blockage and symptomatic hypocalcemia was observed in one procedure each ( . %).there was no corelation observed between physical parameters of patient with adverse events. all adverse events were managed as per departmental standard operating procedures (sops) and procedures were completed successfully except in one where the procedure was abandoned. no mortality was observed during the procedures. background: the hemoglobin (hb) content of packed red blood cell (prbc) units is heterogenous. the patient's blood volume is also variable which can be calculated based on the weight, height and body surface area (bsa) of the patient. the efficacy of a transfusion episode can be assessed if the hb content of prbc is known and the patient's post-transfusion hb increment is determined. aims: this prospective study was performed to compare the efficacy of the transfusion of prbcs based on hb content versus the standard transfusion practice in thalassemia major patients. we also determined the correlation between hb increment and the hb content of prbc units transfused. methods: a total of registered thalassemia major patients of our institute were included in the study after excluding the patients who had allo-or auto-antibodies. the study was approved by the institute ethics committee. the enrolled patients were randomly divided into two groups: group i (n = )they received abo/rhd identical prbcs suspended in additive solution (saline, adenine, glucose, mannitol: sagm-prbcs) after determining its hb content (units with hb content ≥ g); and group ii (n = )they received randomly selected abo/rhd identical sagm-prbcs. the hb estimation of the randomly selected units in group ii was blinded. following tests were done on pre-transfusion sample: hb estimation using the hematology analyzer (orion , ocean medical technologies, india), blood grouping using tube technique, anti-human globulin (ahg) crossmatch and direct antiglobulin test (dat) using gel technique (biorad, switzerland), antibody screening (abs) using a fully automated immunohematology analyzer (neo, immucor, usa). on the posttransfusion sample collected h after transfusion, hb estimation and dat were performed. results: there was no significant difference among the patient characteristics of the two groups. the mean hb content of the sagm-prbc units was significantly higher (p = . ) in group i (mean ae standard deviation: . ae . g; range: . - . g) than group ii ( . ae . g; range: . - . g). the mean hb increment in group i patients ( . ae . g/dl) was significantly higher (p = . ) than the group ii patients ( . ae . g/dl). in both the groups i and ii, there was a significant negative correlation between hb increment and weight (p = . in groups i and ii), age (p = . for group i; p = . for group ii), body surface area (bsa) (p = . for group i; p = . for group ii) and blood volume (p = . for group i; p = . in group ii). in both the groups i and ii, there was a significant positive correlation between hb increment and hb dose adjusted for bsa and the hb dose adjusted for blood volume (p = . in both groups i and ii for both the parameters). summary/conclusions: the efficacy of transfusion is more when patients are transfused with sagm-prbcs having hb content of g or more as compared to those who are transfused with randomly selected units. for optimal hb increment in thalassemia major patients, the transfusion strategy should be based on the hb content of the sagm-prbcs. background: in male transfusion recipients under years of age, receiving red blood cells (rbcs) from an ever-pregnant blood donor has been associated with increased mortality, compared to receiving a product from a male donor. although it has been suggested that older units of rbcs could be associated with increased mortality, there are significant methodological challenges in these studies. other studies indicated the freshest units of rbcs could be associated with increased mortality among transfusion recipients. we hypothesize both the association between ever-pregnant donors, and fresh units, with mortality could be caused by passenger leukocytes in the transfused rbc units, which decay during storage. aims: to quantify modification of the effect of ever-pregnant donors on mortality in young male rbc transfusion recipients, by storage time. methods: data on transfusion recipients receiving their first-ever rbc transfusion in one of six major dutch hospitals between / / and / / was collected. for the current study, male transfusion recipients under years receiving only transfusions from one donor sex exposure category were selected and followup was censored at three years after transfusion. differences in storage time between groups were estimated by linear regression, adjusted for total number of transfusions, patient age, blood group, transfusion year and month. in a single-unit, single-transfusion cohort, cumulative mortality was estimated separately for patients receiving transfusions from ever-pregnant or male donors and for 'fresh' (< days storage) or 'old' (> up to days storage) rbcs. results: for recipients of only blood from male donors, the storage time of the freshest unit was . day shorter when comparing the patients who died, to , patients who survived (ci: À . to . ). for recipients of only blood from ever-pregnant donors, the storage time of the freshest unit was . day longer when comparing the patients who died, to patients who survived (ci: À . to . ). in the single-transfusion cohort, , patients received a fresh rbc transfusion from a male donor, of whom died; patients received a fresh transfusion from an ever-pregnant female donor, of whom died. patients received an old transfusion from a male donor, of whom died; patients received an old transfusion from an ever-pregnant female, of whom died. the -years cumulative incidence of death among young male recipients was . % (confidence interval (ci): . % to . %) after a fresh transfusion from a male donor and . % (ci: . % to . %) after a fresh transfusion from an ever-pregnant female donor. the -years cumulative incidence of death was . % (ci: . % to . %) after an old transfusion from a male donor and . % (ci: . % to . %) after an old transfusion from an everpregnant female donor. summary/conclusions: prolonged storage of rbcs from ever-pregnant donors was not associated with decreased mortality at years. contrary to our expectations, our results indicate older units may potentiate the effect of ever-pregnant donors. however, due to limited sample size the observed differences were not statistically significant. background: according to the literature review, there was limited impact of premedication (antipyretics, antihistamines and steroids) before transfusion on the prevention of adverse transfusion reactions (atrs). however, the necessity of premedication remains controversial. the premedication before transfusion is still a common clinical practice in pacific-asian countries, along with the premedication rate ranging from to %. in our previous investigation, we found that premedication rate was . % in the outpatients in , which was much higher than the reported rate in asia. aims: to investigate the incidence of atrs and decrease premedication rate without increasing the rate of atrs via education and evidence-based clinical practice. methods: the incidence of atrs from april to december, was retrospectively surveyed. evidence-based clinical practice was initiated since january, . clinical data of the outpatients receiving transfusion therapy were requested and analyzed from january to september, . the incidences of atrs and premedication rates in and were compared using chi-square test. a p value less than . was statistically significant. besides, feedback of the incidence of atrs and premedication rate was given quarterly to the clinicians during the investigation. results: from april, to september, , a total of , blood units were transfused in the outpatients with , transfusion events. of these, cases of atrs, including febrile nonhemolytic transfusion reactions (fnhtr) and minor allergic reactions were reported. the overall premedication rate in the outpatients was . % in , and was significantly decreased to . % in (p < . ). it was reported that the incidences of atrs in and were . % and . % per unit, respectively. there was no remarkable difference between the incidence of atrs in and (p = . ). summary/conclusions: via education and evidence-based clinical practice, we successfully reduced premedication rate without increasing the rate of atrs in the outpatients. furthermore, introduction of computerized provider order entry (cpoe) and clinical decision support system (cdss) could be considered and be expected to prevent unnecessary premedication before transfusion, increasing the compliance with optimized transfusion strategies in the future. methods: a retrospective analysis was done over a period of one year to evaluate clinical efficacy of granulocyte transfusions in hemato-oncology patients with febrile neutropenia. mobilization of granulocyte donors was done as per standard protocol, which included subcutaneous injection of granulocyte colony stimulating factor (g-csf) - lg/kg and tablet dexamethasone mg, - h prior to granulocyte harvest by apheresis. all granulocyte products were gamma irradiated before transfusion. patient parameters like white blood count (wbc), absolute neutrophil count (anc), hemoglobin and platelet count were recorded pre-and post-granulocyte transfusion. infection related mortality (irm) within days of granulocyte transfusion was also recorded. results: minimum adequate granulocyte yield of per unit was fulfilled in % of granulocyte harvests. clinical indications for granulocyte transfusions were fever, an absolute neutrophil count (anc) < /ll, evidence of bacterial and/or fungal infections (i.e. clinical signs of infection, positive cultures and radiological evidence) and unresponsiveness to appropriate antimicrobial therapy for at least h. effects of clinical, microbiological and granulocyte transfusion related variables on infection-related mortality were investigated. the post transfusion anc (within h) increased significantly (median value: /ll) as compared to baseline levels (median value: /ll) (p < . ). infection related mortality was observed in only % ( out of ) of patients. patients became afebrile within - days and culture negative within - days after granulocyte transfusion. for analysis purpose granulocyte transfusion episodes were grouped according to doses of granulocyte transfusions, based on european guidelines (standard dose: . - . cells/kg and high dose: > . cells/kg background: hsa's blood services group (bsg) is singapore's national blood service. in , we conducted our pilot national pbm audit to promote pbm practices. it was agreed that the audit would be performed annually with incorporation of a new indicator to continue promotion of pbm and sharing of good practices. aims: to provide an update on the second national pbm audit for . results are compared to the pilot audit and summarized below. methods: we collected data on performance indicators from acute public care hospitals for weeks each in march and august (the pilot audit covered weeks in ). the performance indicators were: ). percentage compliance to documentation of red blood cell transfusion indications ). percentage of patients screened for pre-operative anaemia, to days before surgery ). peri-operative transfusion rates ( days before to days after surgery) for commonly performed surgeries: coronary artery bypass graft surgery (cabg), total knee replacement (tkr), total hip replacement (thr), nephrectomy, colectomy and hysterectomy. the first two indicators assess pbm efforts and were measured in the pilot audit. indicator ) was added to the second audit to assess impact of pbm practices on transfusion in surgical patients. it was an appropriate time to incorporate this indicator as the hospitals would have been familiar with pbm since its introduction in . results and recommendations were shared with the senior management and hospital transfusion committees of the participating hospitals. results: for indicator ), hospitals had a compliance of - %, the remaining had a compliance of - %. all hospitals incorporated electronic blood ordering but the usage was not compulsory in some. hospitals which mandated electronic ordering performed better as doctors could only order blood products after entering the transfusion indication. we saw compliance increase from % in to % in a hospital that had newly mandated electronic ordering. for indicator ), results ranged from % to %. hospitals made notable improvements when compared to , achieving % and % respectively. they had implemented pre-operative workflows screening all elective surgical cases for anaemia at least weeks before surgery. one hospital also started an outpatient intravenous iron service which reduced pre-operative anaemia rates. for indicator ), mean number of transfused units for each surgery ranged from . to . units per patient, lowest being thr and highest being cabg. this suggests that some transfusions were potentially avoidable with more robust pbm practices. the rate of perioperative transfusions was highest for cabg at % and lowest for tkr at %. summary/conclusions: the annual national pbm audit increases pbm awareness, allowing hospitals to share and learn good practices and implement measurable improvements. based on this audit, a recommendation to mandate electronic ordering of blood products to improve adherence to red cell transfusion indications and implementing pre-operative workflows with consideration for intravenous iron support was made. this audit was more representative than the pilot, with a longer duration of data collection and incorporation of indicator ) showing impact of pbm practices. background: autoimmune haemolytic anaemia (aiha) is a decompensated acquired haemolysis caused by the host's immune system acting against its own red cell antigens. aiha is a rare disorder and although british society of haematology (bsh) guidelines for diagnosis and treatment were published in february , there is little evidence for clinical practice in the united kingdom. aims: to investigate the approach to the diagnosis, investigation and management of patients with autoimmune haemolytic anaemia (aiha) in english nhs trusts. methods: we designed and distributed a survey to the clinical transfusion leads at all english nhs trusts between november and march . the survey requested information on detailed, simulated clinical scenarios. the first simulated scenario described a young patient with active aiha months after an allogeneic stem cell transplant, who has received multiple transfusions in the last weeks and is hypotensive, tachycardic, with a falling haemoglobin (hb), currently g/l. the second scenario describes a young man with a new diagnosis of warm aiha who has an initial hb of g/l and returns to clinic at a -week interval with symptoms of fatigue. he is actively haemolysing and commenced on mg/kg prednisolone. results: there was a % ( / ) response rate by trusts. faced with a - h delay for allo-adsorption studies, % ( / ) of respondents would instead transfuse acutely with abo, rh and k matched red cells negative for any previously detected alloantibodies, % ( / ) would transfuse with o rh d negative red cells and % ( / ) would wait for completion of allo-adsorption studies before transfusing. in this first scenario, a quarter of respondents appeared to delay a potentially lifesaving blood transfusion. british society of haematology guidelines recommend that when anaemia is life-threatening in the time required for full compatibility testing, abo, rh and k matched red cells should be transfused. in the serious hazards of transfusion (shot) report, the most serious and fatal of cases of preventable delayed transfusion was a patient with aiha who died untransfused with an hb of g/l, while awaiting alloadsorption studies. a key shot message was that if clinical harm to patients from withholding blood outweighs safety concerns over a possible delayed haemolytic transfusion reaction, emergency blood is essential and should be offered. the second scenario also identified considerable variation in transfusion practice. it can take several weeks for patients with aiha to respond to prednisolone so a transfusion threshold < g/l after an hb fall of at least g/l in the previous weeks is perhaps overly conservative. summary/conclusions: the overall findings support a need for studies to explore barriers to uptake of guidelines, and to identify areas for further audit and research to guide safe and appropriate transfusion practice in aiha. background: balance between supply and demand of o d negative red cells remains a challenge for almost every blood service. with this re-audit, we wanted to collect objective and comprehensive information regarding usage of o d negative red cells supplied by nhs blood and transplant (nhsbt) to private and nhs hospitals in england. aims: the aim was to understand hospital practices, actual needs and possible avoidable usage of o d negative red cells. where possible, comparisons were made with two previous audits ( ) ( ) ( ) . methods: participating hospitals were asked to determine the fate of all group o d negative red cells they received between th and th may excluding substitutions and complete an organisational survey regarding activities, policies and stockholding practices with respect to o d negative blood. participating hospitals were asked to provide (if available) the prevalence (as a percentage) of o d negative patients in their population. this information, in conjunctions with hospital activities, will be used to estimate appropriate o d negative stockholding levels. background: o rhd-negative (neg) red blood cells (rbcs) are a precious resource, are often in short supply and transfusion of these units in emergency settings carries the potential risk of transfusion-related adverse outcomes such as haemolytic reaction due to minor blood group incompatibility. as such, their use should be closely monitored within health services. most recent australian guidelines ( ) for their use in emergency settings include pre-menopausal females of unknown blood group (mandatory indication) or while the blood group is being established; use should be limited to or less units where possible before a switch to group-specific rbcs (acceptable indication). aims: audit of use of emergency uncrossmatched o rhd-neg rbcs against national guidelines in our institution (an australian tertiary metropolitan public hospital providing acute medical and surgical, emergency and critical care services). methods: use of emergency uncrossmatched o rhd-neg rbcs units over a six-year period was retrospectively reviewed. we collected information about rbcs transfused and discarded, adverse outcomes, patient characteristics, clinical indications and whether use met national guidelines or could have been avoided. results: episodes of emergency uncrossmatched o rhd-neg rbcs were identified, encompassing transfusion of rbc units to patients and the discard of rbcs (due to incorrect transport). of the episodes, episodes ( %) involved an eventual switch to group-specific rbcs (range of emergency units, - units). the main requester was the emergency department ( %). the most common clinical indication for transfusion was acute gastrointestinal bleeding ( %). of the episodes, episodes ( %) did not meet the guidelines for emergency use because > units of emergency uncrossmatched o rhd-neg rbcs were issued. episodes ( %) were flagged as potentially inappropriate as the patients were clinically stable according to documentation in the medical records. episodes ( %) were identified as potentially preventable due to delay in pre-transfusion sample collection (defined as > h elapsed between patient arrival and group and screen sample collection) in the setting of acute bleeding ( %), receipt of an unsuitable pretransfusion sample requiring sample recollection ( %), delay in pre-transfusion sample processing ( %), no valid pre-transfusion sample being available at the time of the bleeding episode despite having a planned elective procedure or being an inpatient with recent clinical bleeding ( %). only one patient was investigated for potential transfusion-related adverse outcome ( %) which was thought likely due to concurrent sepsis. summary/conclusions: over six years, episodes utilising emergency uncrossmatched o rhd-neg rbcs were identified with rbcs issued and rbcs discarded. a significant proportion of episodes ( %) were potentially avoidable if there had been a valid pre-transfusion sample available in the transfusion laboratory at the time of the episode. efforts to minimise use of this precious resource are ongoing, and include feedback to clinical units regarding importance of valid pretransfusion samples prior to applicable invasive procedures and in bleeding patients, ongoing education to medical and nursing staff, and continuing audit of use of this blood component in the hospital haemovigilance programme. abstract withdrawn. abstract withdrawn. background: platelet transfusions are often given prophylactically to thrombocytopenic hematology patients. to which extent platelet function improves after transfusion, and how this improvement correlates with an increase in platelet count, is not well studied. flow cytometry has been used to evaluate platelet function after transfusion in a few studies and can be performed even at low platelet counts. rotational thromboelastometry (rotem) represents a more physiological measure of platelet function in whole blood that has not been extensively used in transfusion settings. we used these methods to investigate if platelet transfusion improves platelet function in hematology patients and if improvement correlates with increased platelet counts. aims: the aim was to evaluate the relationship between response to platelet transfusion, measured as corrected count increments (cci), and platelet function in thrombocytopenic patients with hematological disorders. methods: blood samples (sodium-citrate anticoagulated) were collected from unselected hematology patients receiving prophylactic platelet transfusions, after informed consent had been obtained. samples were taken at three time-points: within h before transfusion, h after and - h after transfusion (via a central venous catheter or a subcutaneous venous port). for each time-point, platelet response to adenosine diphosphate (adp) and thrombin receptor-activating peptide (trap- ) was assessed by flow cytometry by measuring p-selectin and pac- expression on single platelets. rotem analysis was also performed on all samples, using intem and extem reagents. results: an interim analysis was performed after inclusion of patients. the mean platelet count before transfusion was /l (range - /l). h cci was /l and - h cci was /l, but response was highly variable. pselectin expression after stimulation with adp and trap was significantly higher at h after and - h after transfusion compared to before transfusion (p < . ). pac- expression after stimulation with adp was significantly higher at - h after transfusion (p < . ), but not at h after transfusion. in rotem, clot amplitude at and min (a and a ) as well as maximum clot firmness (mcf) improved after transfusion (p < . ). a significant correlation between absolute platelet count and p-selectin expression after trap and adp stimulation was found (r s = . and . respectively, p < . ). absolute platelet count was also significantly correlated with mcf (r s = . , p < . ), where % of patients with a platelet count of more than /l reached mcf values within the reference interval. summary/conclusions: platelet function generally improves after transfusion and was in our patient population correlated to the absolute platelet count, but was also seen at the single platelet level in flow cytometry. a post transfusion platelet count of more than /l might be sufficient to significantly improve coagulation in heavily thrombocytopenic patients, but larger studies are needed to confirm this conclusion. abstract withdrawn. abstract withdrawn. background: sickle cell disease (scd) is a genetic disorder that is frequently referred to as a hypercoagulable state. hydroxyurea (hu) is known to decrease the frequency of vaso-occlusive complications and need for blood transfusions in severely affected individuals. although cross-sectional studies show that treatment with hu is associated with decreased coagulation activation, there are no prospective studies evaluating the effect of hu on coagulation activation. aims: to assess the effect of hu on markers of fibrinolysis (d-dimer) and endothelial activation (soluble vascular cell adhesion molecule- [soluble vcam- ]) in patients with scd in their non-crisis, "steady state." methods: patients, at least years of age, with documented hbss or hbsb-thalassemia, eligible for treatment with hu were studied in this prospective, observational study. laboratory investigations were obtained at baseline, prior to commencement of therapy with hu, with repeat evaluations at three and six months of therapy. non-parametric test was applied to observe the association between hu therapy and the biomarkers of interest. results: twenty-five patients with scd (hbss: , hbsb thalassemia: ) were enrolled (females: [ %]), with a median age of years (iqr: ). following months of hu, median values for wbc count ( . /l vs. . /l, p = . ) and d-dimer ( . ng/ml vs. . ng/ml, p = . ) were significantly lower than baseline values, while the mean corpuscular volume ( . fl vs. . fl, p = . ) was significantly higher than the baseline value. no significant differences from baseline were observed in the median values for hemoglobin ( . g/ dl vs. . g/dl, p = . ), platelet count ( /l vs. . /l, p = . ), lactate dehydrogenase ( u/l vs. . u/l, p = . ) or soluble vcam- ( . ng/ ml vs. . ng/ml, p = . ) following months of hu therapy. summary/conclusions: this exploratory study confirms that treatment with hu is associated with decreased coagulation activation in patients with scd, although no effect on endothelial activation was observed. by decreasing coagulation activation, hu may decrease the risk of thrombotic complications in scd. abstract withdrawn. abstract withdrawn. transfusion medicine, apollo gleneagles hospitals, kolkata, india background: reduction of immune responsiveness through blood transfusion has been documented by previous authors. breast cancer is considered as one of the commonest cancer globally and the second main cause of death in females transfusion of allogeneic blood in breast cancer surgery is variable and differences of transfusion incidence have been observed in the literature. where the maximum surgical blood ordering schedule (msbos) dictates cross matching and reservation of blood before surgery, factors deciding their utilization are varied and numerous. our hospital protocol guides that every patient planned for elective breast cancer surgery should routinely have a blood sample sent for reservation of one unit of compatible packed red blood cell (prbc) in the blood bank. aims: in this prospective study we aimed to audit the blood utilization in patients undergoing elective breast surgery and thereby optimize the blood ordering schedule, economic burden and loss of clinical resources. methods: the study included confirmed breast cancer patients planned for elective breast surgeries from january to december . patient and disease details like age, stage, tnm status, estrogen receptor (er) and progesterone receptor (pr) status, human epidermal growth factor receptor (her - ) expression, triple negative breast cancer (tnbc) status, reproductive and treatment status were documented. patients were divided into younger group [≤ years] and older group (> years). before surgery blood samples for compatibility testing were sent to blood bank for blood reservation. details of test, blood issue and blood transfusion were documented in the blood bank. approximate loss of time in minutes and wastage of resources in terms of money (inr) in the blood bank were noted. all results were calculated as mean ae sd and a 'p' value of < . was considered statistically significant. results: of the total patients most underwent wide local excision of the breast and modified radical mastectomy. a total of patients received units of blood and blood components in all categories of surgeries. only were younger women (≤ years) with mean age of years. non-transfused patients were significantly more than transfused ones (p < . ). frequency of blood transfusion was more in young patients ( . %). seven ( . %) of the total stage iv patients received blood transfusions. frequency of blood transfusion was more in patients undergoing surgery after chemotherapy ( . %). a significant loss of time and loss of revenue was observed. summary/conclusions: we conclude that routine compatibility test is not justified for all patients undergoing breast surgery. a more targeted approach is needed to reduce blood demand and associated cost to patient and blood transfusion services. background: blood transfusion guidelines are not only essential for the optimal use of blood products, but also help reduce transfusion-related adverse reactions and improve patient outcomes. the korean national transfusion guidelines were developed in and fully revised in by the korean centers for disease control and prevention and the korean society of blood transfusion. in our hospital, which is a -bed university hospital, a transfusion-indication data-entry program based on the national transfusion guidelines was developed in . it was applied to the electronic medical record system and all transfusion orders, except emergencies, have been performed through this program since then. aims: we planned to record and analyze the reasons for transfusion in order to monitor blood product usage and provide feedback to clinicians. furthermore, we intended to contribute to patient safety through the appropriate use of blood products. methods: we classified transfusion-indications by the blood product requested and created a pop-up window listing these indications, which would appear at each regular transfusion order. indications for transfusion with each blood product were as follows: red blood cells (rbcs)acute blood loss, chronic disease (sub-classified as hb ≤ g/dl, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, respiratory disease, age ≥ years, age ≤ months, chemotherapy), surgery/ procedure, transplantation and 'other'; platelets (plts)present bleeding, bleeding prevention (sub-classified as hematologic disease, solid tumor, peripheral blood stem cell transplantation, disseminated intravascular coagulopathy, infant), surgery/procedure, massive transfusion and 'other'; fresh frozen plasma (ffp)bleeding in coagulopathy, bleeding prevention in coagulopathy, massive transfusion, plasma exchange and 'other'. transfusion indications entered into the data-entry program from sep to feb were analyzed. results: the number of transfusion-indications analyzed was for rbcs, for plts and for ffps. the most common indications for transfusion were chronic disease for rbcs ( / , . %), bleeding prevention for plts ( / , . %) and 'other' for ffp ( / , . %). 'hb ≤ g/dl' was the most frequent sub-indication of chronic disease ( / , . %), and hematologic disease was the most frequent sub-indication of bleeding prevention ( / , . %). many clinicians entered transfusion indication as 'other': rbcs ( / , . %), plts ( / , . %) and ffp ( / , . %). however, the free-text supplied by the clinician when 'other' was selected, often corresponded to an indication already categorized in the transfusion-indication data-entry program; . % of rbcs and % of plts. of the indications entered as 'other' in ffp, . % were surgery/procedure-related. summary/conclusions: in our hospital, the release of blood products has been dependent on the data-entry of transfusion indications (except in emergencies) since sep . transfusions of rbcs and plts were most common for chronic disease and bleeding prevention, respectively, but many cases entered as 'other' could have been categorized as existing indications in our data-entry program. therefore, we conclude that additional training is needed for clinicians regarding the determination of transfusion-indications and correct use of the transfusion-indication dataentry program, in order to use blood products more appropriately. methods: this was a prospective cohort designed study. subjects were children aged - years with indication of platelet transfusions in sardjito hospital yogyakarta indonesia. the patient samples were collected before and h post-transfusion, the expression of cd p on platelet was determined by flow cytometry method. results: there were subjects who were divided into two groups. fifty-one subjects received non-leukodepleted pcs and the other fifty-one transfused by pre-storage leukodepleted pcs. the mean of pre-transfusion platelet cd p for nonleukodepleted and leukodepleted groups were . % and . %, and the mean increase of post-transfusion platelet cd p for non-leukodepleted was . % and the mean decrease of leukodepleted groups was . %. it was shown the increase of post-transfusion platelet cd p for non-leukodepleted group, and it was significantly (p < . ) higher than in the leukodepleted groups. summary/conclusions: there was an increase of post-transfusion platelet cd p expression in patients received non-leukodepleted, but a decrease in leukodepleted pc transfusions. background: preoperative anaemia is a common finding in patients undergoing surgery and often neglected in our country. aims: the objective of this study was to evaluate hb(values and the identification of cardiac patients who entered operation with anaemia. and also to study the correlation between hb values and the number of rbc (red blood cell) transfused unit methods: this is a retrospective, descriptive and analytical study. the data for this study was collected from the files in the statistic's service at qsut (university hospital center "mother teresa"). the object of our study were the files of patients hospitalized in the period january -may in the cardiac surgery ward, which were subjected to cardiac surgery. from the files were collected data on age, gender, primary diagnosis, accompanying diseases. we also collected hb, rbc, htc (hematocrit), mcv (mean corpuscular volume), mch (mean corpuscular hemoglobin), mchc (mean corpuscular hemoglobin concentration). from the transfusion service at qsut and from the files were pulled out the transfused patients and the number of transfused units. results: based on the who definition for anemia (females < g/dl and males < g/dl), from the patients included in the study, ( %) were anaemic. from males in the study, ( %) of them were anaemic based on hb lab values, whereas from women in the study anaemic were found to be ( %) of them. from the anaemic patients in the study, ( . %) of them with mild anaemia, ( . %) with moderate anaemia and ( . %) with severe anaemia. in the total of anaemic female . % are under , while . % are over/or years old. in the total of anaemic males, % are under , while % are over/or years old. it is noticed that most of them are with normochromic normocytic . %, normocytic hypochromic anaemia . %, hyperchromic microcytic anaemia . %, macrocytic normochromic anaemia and macrocytic hypochromic anaemia respectively . % and microcytic normochromic anaemia . %. the average value of preoperative hb decreased from . g/dl before surgery to . g/dl after surgery, so there is a decrease of approximately . g/dl of hb value. in our patients, % ( ) were transfused and the remaining % ( ) were not transfused. from transfused patients ( %) patients were anaemic. the correlation between the values of hb, rbc, htc and the number of transfusions shows that with the decrease of these values the number of transfused units increases. summary/conclusions: the diagnose of anaemia is underestimated before surgical intervention in our country and investigation of hb low values do not take the proper importance to find probable cause and correct it before surgical intervention. the lower the hb values, the greater the chance to be transfused and the number of rbc transfused units. failure to correct hb values before surgery results in unnecessary transfusions for the patients or which could have been avoided, eliminating also the risk of transfusion complications. background: alloimmunization after red blood cell transfusion is affected by various factors. it is known that the incidence of alloimmunization increases in certain diseases. extended red blood cell matching can be used to prevent the development of alloimmunization in diseases which the rate of alloimmunization is increased. in asia, extended red blood cell matching is not actively implemented. aims: we tried to investigate whether there is a difference in the disease categories between unexpected red blood cell antibody positive and negative groups. methods: from january, to december, , the diseases of the patients who had undergone unexpected red blood cell antibody identification test at dong-a university hospital was examined through medical records. from january to december , the diagnosis was made on patients who had two or more unexpected antibody screening tests. we analyzed the frequency difference of disease category between two groups. results: a total of patients were performed with unexpected antibody identification tests. of patients who underwent more than screening tests, ( . %) were positive. were consistently unexpected antibody negative. the patients with solid tumors (n = , . %) and those with hematologic diseases (n = , . %) had a higher incidence in unexpected antibody positive group. the patients with myeloid malignancy had a significantly higher frequency than lymphoid malignancy (p = . ). the frequency of patients with liver cirrhosis was significantly higher in the unexpected antibody positive group ( / , . %) than in the negative group ( / , . %) (p = . ). the incidence of non-hodgkin lymphoma was significantly higher in the unexpected antibody negative group ( / , . %) than in the positive group ( / , . %) (p = . ). summary/conclusions: there was a difference in the distribution of diseases between unexpected antibody positive group and negative group. the patients with liver cirrhosis were more frequent in unexpected antibody positive group, suggesting that extended red blood cell matching would be considered. background: in hematological patients with multiple platelet transfusions (pc) often develop immune response to human leukocyte associated antigens (hla-i) and human platelet-specific associated antigens (hpa). besides, platelet associated immunoglobulins (paig) and complement components (pac) are found on platelet. this leads to increased platelet destruction and development of refractoriness to transfusions of donors' platelets. transfusion therapy using an individual selection of platelets and plasmapheresis, contribute, in the majority of cases, to the realization of efficient transfusion by pc. but, in difficult cases, there is a need to use intravenous immunoglobulin, which may promote the efficient transfusion of pc. aims: evaluate the algorithms of using the complex therapy of refractoriness to transfusions of donors' platelets with additional application of intravenous immunoglobulin (ivig). methods: in there were three female patients in the clinics of the centre for observation, age between and years (me = ) with the ineffectiveness of complex therapy for overcoming refractoriness to transfusions of donors' platelets due to selection and plasmapheresis. the diagnoses were as follows: aplastic anaemia (aa)- , acute myeloid leukemia (aml)- . individual selection of platelets was carried out by the adhesion method on the solid phase (immucor "galileo neo"). paig and pac / were evaluated by the method of flow cytometry (bd facscanto ii) by the method of double staining with cd a. the density of fixed paig, pac was © the authors vox sanguinis © international society of blood transfusion vox sanguinis ( ) (suppl. ), - evaluated by the median fluorescence intensity (mfi). the two patients with aa received ivig-igg therapy in the standard dose , g/kg per day, for days. one patient with aml received ivig-iggam therapy in the standard dose , ml/kg/day for . results: under pressure of the complex therapy with the use of ivig in the standard dose there was are decrease in mfi over time in the case of two patients: aa- mfi-paigg reduced from to ; while the patient with aml: paiga reduced from to , and paigm from to , pac from to , pac from to . the patient with aa- over time, regardless of the treatment, there was an increase of mfi, but the effect of pc transfusions was achieved under pressure of complex therapy. under pressure of complex therapy all the patients also reduced the frequency of reaction of alloantibodies when resorting to an individual selection and increasing the frequency of compatible couples "donor-recipient". summary/conclusions: delivery of complex therapy and the additional application of ivig enables an adequate transfusion therapy of pc, neutralize hemorrhagic syndrome and continue the treatment of the main disease. detection and monitoring of paig/pac during the development of refractoriness to transfusions of donors' platelets are additional markers for prescription of ivig therapy. anaesthesia, tan tong seng hospital, singapore, singapore background: blood transfusion is quite prevalent in paediatric cardiac surgical procedures. we hypothesized that the routine use of rotational thromboelastography (rotem) to guide transfusion decisions would reduce the overall proportion of patients receiving transfusions in paediatric cardiac surgery aims: the aim of the study was to find if the use of blood and blood products in pediatric cardiac surgical cases in a single centre is affected due to rotem. methods: sixty paediatric cardiac surgical patients undergoing cpb were included in this study. thirty patients (study group) were prospectively included and compared with thirty procedure and age-matched control patients (control group). in the study group, rotem, performed during cpb guided intraoperative transfusions. perioperative transfusions of blood and blood products, postoperative blood loss and hemoglobin levels were compared between the two groups. results: the patients in the control group received fewer transfusions of packed cells ( % vs %) and fresh frozen plasma ( % vs % p<o.oo ). more patients in the study group received platelets ( % vs %) and cryoprecipitate ( % vs %). the postoperative blood loss was lower in study group compared to the control group. the postoperative hemoglobin did not differ between the two groups. summary/conclusions: the results suggest that the routine use of rotem in paediatric cardiac surgery to guide transfusions is associated with reduced proportions of patients receiving transfusions and is evidence based practice. abstract withdrawn. abstract withdrawn. abstract withdrawn. background: mycoplasma pneumonia (mp) infection has often been implicated in respiratory tract infections. although this agent has also been associated with other non-respiratory diseases, hemolytic anemia is the most common hematologic complication of mp infection. episodes of sudden onset of severe anemia are rarely seen in beta thalassemia. we report a -years-old female with beta thalassemia major who was diagnosed to have severe anemia secondary to autoimmune hemolytic anemia induced from mp infection aims: to report a case of patient with beta thalassemia major who was diagnosed to have severe anemia secondary to autoimmune hemolytic anemia induced from mp infection and how it was managed with minimal transfusion. methods: a -year-old female case of beta thalassemia major who developed autoimmune hemolytic anemia following mycoplasma infection. the patient is on monthly blood transfusion since the age of years at dubai thalassemia center. she was admitted to the hospital with days history of dizziness, severe low back and joint pain and her travel history indicated a four-week visit to pakistan. initial investigations showed a hemoglobin level of . g/dl the direct and indirect coombs test were positive. patient was transfused with two units leuko-depleted compatible prbc (o, rh +, negative for e and kell antigens.) and discharged next day. three weeks later, the patient was still with lower limbs pain and the hemoglobin was . g/dl with a positive dat with both igg+ and c + , patient was not transfused as it was difficult to find matching blood; therefore she was given one week follow up. four days later, patient reported to the center with fever, generalized body pain and fatigue. she had significant drop in hemoglobin . g/dl, mcv . , platelets count , crp . , retic count . , blood culture no growth, total bilirubin . , malaria parasite smear was negative, urine culture and microscopy were normal. mycoplasma pneumonia antibody showed positive with igg . and igm . , she was started on azithromycin for days and received units prbc least incompatible leuko-depleted (o, rh +, negative for e and kell antigens.). after which her hemoglobin increased to . g/dl. she did not show any improvement in her condition over the following weeks and repeat mycoplasma pneumonia antibody showed an increased titer, which denoted resistance to azithromycin; hence, we started her with second line of treatment levofloxacin for days. screening for collagen disease were all negative apart from high esr of mm/hr. patient remained afebrile and transfused with least incompatible available blood, post transfusion hb was . g/dl. three weeks later, during her routine follow up, she was doing well with esr dropping to mm/hr and hemoglobin . g/dl, which indicated gradual settling of hemolysis, although the last dat remained positive. subsequent visits showed hb drop of . g/dl/week which is acceptable for transfusion dependant thalassemia. results: with conservative management patient condition improved. summary/conclusions: hemolytic anemia associated with mycoplasma pneumonia is usually self-limited and resolves spontaneously after mycoplasma infection elimination. packed red cell transfusion in transfusion dependent patient may be troublesome and can aggravate the condition; therefore it should be utilized and limited to significant symptomatic anaemia background: early plasma transfusion in women with severe postpartum hemorrhage is often instituted to prevent and treat coagulopathy, but whether maternal outcomes improve with this treatment is unclear. aims: to quantify the association of plasma transfusion within the first min after diagnosing persistent postpartum hemorrhage and adverse maternal outcome. methods: we performed a retrospective cohort study of women with persistent postpartum hemorrhage, defined as postpartum hemorrhage refractory to first-line measures to control bleeding. women were enrolled from january , to january , in dutch hospitals. in a time-dependent propensity score-matched analysis, women with transfusion of fresh frozen plasma within min following the diagnosis of persistent postpartum hemorrhage were matched to women without plasma transfusion or plasma transfusion at a later time point during hemorrhage. plasma transfusion was not guided by coagulation tests. the main outcome measure was adverse maternal outcome, defined as a composite of mortality, hysterectomy and arterial embolization to control bleeding. we performed sensitivity analyses with initiation of plasma transfusion within and within min following diagnosis persistent postpartum hemorrhage, compared with other plasma transfusion strategies. results results: the cohort consisted of women with persistent postpartum hemorrhage, with uterine atony as cause of hemorrhage in women ( . %). in this cohort, seven maternal deaths ( . %), hysterectomies ( . %) and arterial embolizations ( . %) were observed. plasma transfusion within min in women was matched on time-dependent propensity scores with women with no or later plasma transfusion. rate of adverse maternal outcome was similar between women with and without early plasma transfusion, . % versus . %, adjusted odds ratio . ( % confidence interval . - . ). results of sensitivity analyses were comparable to the primary results. summary/conclusions: among women with persistent postpartum hemorrhage, initiation of plasma transfusion within min following this diagnosis was not associated with improved maternal outcomes, compared with no or later plasma transfusion. whether other transfusion strategies or identification of women with high risk of coagulopathy will improve maternal outcomes remains to be studied. background: preoperative evaluation of increased risk for perioperative bleeding is essential for cardiac surgery patients. platelet aggregation, as a laboratory test for assessment of platelet function, is very efficient for optimal antiplatelet treatment and also for assessment of the increased risk of postoperative bleeding and perioperative application of allogenic red blood cell transfusions. aims: the aim of this study was to establish whether preoperative platelet function testing for the presence of residual effect of acetylsalicylic acid (asa) on platelet aggregation can be correlated with an increased risk for intraoperative bleeding during cardiac interventions. methods: a retrospective study included patients who underwent surgical procedures (cabg ii and cabg iii) at the department of cardiovascular surgery, clinical center in ni s in period november -july . patients were previously taken asa at a dose of mg per day, but therapy was discontinued days before surgery. platelet aggregation was measured on the day of surgery using impedance aggregometer multiplate (multiplate platelet function analyzer, roche), using trap and aspi tests. patients were divided into two groups: control group (cg), which included patients with preserved function of platelets (aspi - au*min), and examined group (eg), which included patients with inhibited platelet aggregation in aspi test (< au* min background: hemophilia b is an x-chromosome-linked inherited bleeding disorder resulting from reduced levels or an absence of factor ix clinically represented by recurrent prolonged bleeding. mutations can be inherited or acquired de novo. de novo mutations arise in about one-third of patients with haemophilia. the disease affects primarily males, but approximately % of carrier females have factor ix clotting activity lower than % and are at risk for bleeding. aims: case report of a hemophilia b carrier. methods: the clinical history of the patient was thoroughly studied by analyzing medical records and analytical results using the software available in the health institution and paper records. results: year old woman, with no history of abnormal haemorrhage, healthy, up to when, after a dystocic delivery, presents with subcutaneous and ocular haemorrhage and dispersed bruises. a basic coagulation study is performed and a level of % fix is found. genetic analysis reveals a mutation in fix gene and she is diagnosed as a carrier of hemophilia b. except for a son, no other direct family members carry the mutation. in , after total hysterectomy with bilateral adnexectomy due to an invasive carcinoma in the uterine cervix, the patient suffers a haemorrhagic shock with multiple transfusion support and around six months later undergoes an ureteronephrectomy also with the need for post-surgery transfusion support. the patient is referred to the immunohemotherapy department where she has regular appointments as an outpatient since . in , she requires surgery for the removal of a thyroglossal duct cyst, which is performed under prophylactic treatment with iu recombinant fix (rfix) daily, for four days, and up to h after discharge maintaining basal levels of fix of % and with no major complications reported. in , the patient is admitted to the er in haemodynamic shock and a history of black stools and syncope. at admittance, she receives a bolus of iu of rfix and requires severe transfusion support due to active bleeding. she is diagnosed with colonic angiodysplasia and undergoes surgery. daily doses of iu rfix are administered from day (d ) and up to d maintaining fix levels around - %. the patient is operated at d under the cover of iu of rfix, twice per day, and up to d after surgery reaching fix levels of around - %. at d the dose was diminished to iu of rfix daily and at d she is discharged with no rfix replacement therapy necessary in ambulatory. since then, no complications or new occurrences have been reported. the patient is under prophylactic administration of rfix prior to minor invasive procedures (nodule biopsy, dental extractions and colonoscopies). summary/conclusions: hemophilia b carriers usually do not require any major health care for their daily routine or invasive procedures. however, in the case reported, basal fix levels conditioned any minor intervention to be performed. thus, this carrier must be considered as a moderate hemophilia b patient and mandatory prophylaxis with rfix must be performed prior to any invasive procedure. background: blood transfusion is a life saving procedure but transfusion associated complications are equally important that need to be addressed. with limited resources of blood donations and screening, excessive transfusions must be avoided to prevent risk and economic burden on patients. on the other hand discussion on appropriate use of blood product is a matter of debate in medical literature. it is recommended to restrict the liberal use of transfusion. aims: in this regard we aimed to observe the frequency of genuine and non genuine transfusion at our hospital and also to compare the outcomes of liberal and restrictive transfusions. methods: it was a cross sectional study carried out at nibd and bmt, pechs campus, karachi, pakistan, from february to january . the study was approved from institutional review board. pack red cells (prc) transfusion in case of < g/dl hemoglobin (hb) with cardiac history and < g/dl hb with symptomatic anemia was considered genuine. platelets transfusion in case of sepsis and count < /l, sepsis with bleeding and < /l, patients on active chemotherapy without bleeding but platelet count < /l and in patients presented with bleeding was considered genuine. patients who were presented with bleeding, deranged coagulation profile and with sepsis + bleeding considered genuine for fresh frozen plasma (ffp) transfusion. spss version . was used for descriptive and inferential statistics. results: a total of transfusions were evaluated for genuine and non genuine transfusion. male predominance was high in our data ( %). out of , ( %), ( %) and ( %) prcs, platelets and ffp were transfused respectively. out of platelets, ( %) were platelet apheresis. / ( %) prcs and / ( %) platelets were non genuinely transfused as per the criteria described in methods. however, ffp and platelet apheresis were genuinely transfused. in non genuine group of platelet transfusion, all patients received more than unit platelet and the increment of platelet count post transfusion was found statistically non significant (p = . ). thirty six ( %) of transfusions were done with more than units of prcs in non genuine group. the mean hb level of patients received unit and more than units prcs was statistically same (p = . ) and it was found out that there was same increment in hb in both the groups post transfusion. (p = . ). summary/conclusions: we concluded that although blood transfusion is an integral procedure for saving life yet correct use of blood products is necessary in the era where blood donations are scarce and blood transfusion has its potential associated hazards. the approach towards the appropriate use of blood products will not only minimize the risk of transmission of infectious diseases but also will reduce the economic burden. longitudinal studies on large sample size are needed to validate this study. uncertain. an ovine model enables comparisons of; (a) invasive and non-invasive methods to measure oxygen delivery and utilisation at a tissue level, and of (b) the efficacy of various resuscitation fluids and transfusion protocols in treating haemorrhagic shock. aims: to develop an ovine model of haemorrhagic shock. methods: sheep (n = ) were anaesthetised, ventilated and instrumented. instrumentation included blood flow, perfusion, and microdialysis probes placed in the brain, kidney, liver and skeletal muscle. haemodynamic, tissue oxygenation, tissue flow and respiratory data were recorded continuously by data capture software. non-invasive assessments, including brain and muscle oxygen saturation by nirs, and visualisation of sub-lingual microvascular perfusion, as well as arterial blood gas measurements and plasma/serum/urine collections were made at specific timepoints. after a baseline period ( h) sheep were bled~ % of their estimated blood volume (estimated at ml/kg) to a mean arterial blood pressure (map) of - mmhg. sheep were then resuscitated with either plasmalyte â (up to ml/kg/ hr; n = ) or transfused with sheep red cells (n = ) to achieve a map > mmhg. sheep were euthanised h after resuscitation. data are presented as mean ae standard deviation. results: sheep were haemorrhaged an average of . ae . ml blood which combined with iatrogenic blood loss (~ ml) corresponded to an average . ae . % blood loss. two out of the four sheep met clinical criteria for haemorrhagic shock (map = - mmhg, lactate > mm, svo < %). across all four sheep the nadir map averaged . ae . mmhg, lactate peaked at . ae mmol/ l, and nadir svo was . ae . %. all sheep survived to the end of the experimental protocol. summary/conclusions: these data demonstrate the successful induction of haemorrhagic shock in an ovine model. further experiments are planned to improve the protocol and to achieve % incidence of haemorrhagic shock, and then to compare invasive and non-invasive measures of oxygen delivery and utilisation as well as the efficacy of different resuscitation fluids and red cell transfusion. adverse events, including trali p- bilirubin were recorded within the -day period. the clinical parameters were compared against the reaction strength of the antibody reactions. the automated strength was measured by solid phase. the manual testing consisted of a -min incubation using liss and adding monospecific igg. the dat was performed manually by adding poly-specific igg and then testing with monospecific igg and c d. the rh group and non-rh group had and cases performed manually, and results were + or weaker further indicating the manual strength did not correlate with the clinical hemolysis. likewise, in / ( %) the dat was negative, and did not show any correlation with clinical hemolysis. however, when ldh and bilirubin were measured, the two parameters increased as the automated strength of the antibodies increased. summary/conclusions: most of the dshtr investigation was not associated with overt accelerated red cell destruction. a strong correlation was observed only between the automated immunohematology testing results and other laboratory markers of hemolysis. in our experience, the direct antiglobulin test and manual strength showed no correlation. background: numerous transfused patients present severe, sometimes critical clinical conditions. the occurrence of adverse transfusion reactions (atr) may induce deterioration in the clinical condition with a worsened clinical course and a lifethreatening or fatal outcome as is the case with nervous system impairment. in france, in , out of , notified atrs, ( . %) and ( . %) were life-threatening and death respectively. aims: our aim was to evaluate the notified atrs with neurological signs that occurred in transfused patients over a period of six years and six months in hospitals in the auvergne rhône alpes area. the study included patients with reported atrs in hospitals in this area from january st to june th . each atr was registered in the national haemovigilance database system. two signs observed at the time of the atr were analyzed: unconsciousness and convulsions. stroke was excluded. the type of atr, its severity, the blood product involved and its imputability were studied. results: during the period under study, , atr were reported, of which included unconsciousness and/or convulsions ( . %). of these patients, were females ( . %) and males ( . %). unconsciousness alone was frequently observed ( reports, . %). convulsions were notified in reports ( . %) and were associated with unconsciousness in of them. the diagnosis of seizure, with no other clinical signs, was established in cases ( . %). unconsciousness and/or convulsions were present in allergic reactions ( . %), cases of transfusion-associated circulating overload ( . %), cases of suspected transfusion-transmitted bacterial infections and hypertensive reactions. in allergic atrs, unconsciousness was notified in cases and unconsciousness associated with convulsions in one. twelve atrs were severe ( . %), were life-threatening ( . %) and in cases, they resulted in the death of the recipient ( . %). of the allergic atrs, were severe and life-threatening. red blood cell concentrate was involved in atrs ( . %) and platelet concentrate in ( . %), including cases with apheresis platelet concentrate and cases with pooled platelet concentrate. fresh frozen plasma was involved in atrs ( . %). nevertheless, the imputability of the blood product was excluded or unlikely in atrs ( . %). in the suspected transfusion-transmitted bacterial infections, the imputability of the transfusion was ultimately excluded after a negative result was obtained in the bacterial culture of the blood product. the imputability of the blood product was probable or possible in and atrs respectively, but was certain in only atrs. summary/conclusions: unconsciousness and/or convulsions were rarely observed in atrs notified in transfused patients. nevertheless, the presence of these signs highlights the seriousness of the atr ( ars, . %). lastly, the imputability of the blood product was often excluded or unlikely. in the multivariate cox model for the effect of lpi on overall survival, adjusted for age and ipss-r category, elevated lpi levels were associated with inferior overall survival (hr . , % ci . - . , p = . ). this effect was most pronounced in the td-rs subgroup (hr . , % ci . - . , p < . ). similarly, elevated lpi levels were associated with inferior pfs (hr . , % ci . - . , p < . ) for the whole study population and the td-rs subgroup (hr . , % ci . - . , p < . ). in total patients received iron chelation during the sample collection period ( patients deferasirox, patients desferrioxamine). lpi levels were normal in out of the samples collected during deferasirox treatment and in out of samples collected during desferrioxamine treatment. summary/conclusions: transfusion dependency is associated with the presence of toxic iron species and inferior overall and progression-free survival in lower-risk mds patients. in td-rs patients the effects were most pronounced indicating ineffective erythropoiesis leading to additional iron toxicity. background: post-transfusion immunomodulation has been reported to contribute to poor patient outcomes. clinically relevant transfusion models are needed to improve our understanding of underlying mechanisms. sheep transfusion models are of increasing importance in blood transfusion research as they provide several advantages over small animals, including their size, anatomy, physiology and similar blood volume compared to human. a current limitation of sheep transfusion models is the lack of characterisation of the sheep immune system. understanding the sheep immunology is necessary to advance sheep transfusion models, identify mechanisms that contribute to post-transfusion immunomodulation and facilitate the translation of findings into clinical settings. aims: to characterise the sheep leukocyte inflammatory responses to in vitro lipopolysaccharide (lps) challenge in edta and heparinized whole blood. methods: edta and heparinized sheep whole blood (n = of each) was cultured with rpmi media ( °c, % co ) alone or with the addition of lps ( - lg/ml; derived from escherichia coli : b ). the inflammatory response was assessed after h (h), h, h, h, h and h. supernatant was harvested at each time point and stored at À °c. inflammatory cytokine/chemokine production was determined using sheep specific in-house elisa (il- b, il- , il- and il- ). twoway analysis of variance with bonferroni's post-test was used to measure the effect of incubation time and concentration compared to no lps matched samples. results: when edta was used as an anticoagulant, addition of lps resulted in production of sheep il- b and il- but not il- or il- . il- b production was significantly increased following stimulation of lg/ml lps for h (p = . ) and declined following h incubation. release of il- was significant h post-lps stimulation with lg/ml (p = . ) and reached a maximum at h. the use of heparinized blood resulted in a different immune profile as all inflammatory markers tested were detected following stimulation with much lower concentrations of lps ( lg/ml), although the incubation times differed. il- b was significantly increased following h incubation (p = . ), with increasing levels observed up to h post-lps stimulation. il- production was evident from h and reached significance at h post-lps stimulation (p = . ). il- was significantly increased following stimulation of lg/ml lps for hr (p = . ) with lower concentrations of lps resulting in il- production at h (p = . ). release of il- was significant after h of lg/ml lps stimulation (p = . ), with lower concentrations of lps resulting in il- production at h (p = . ). in heparinized whole blood an lps concentration-dependent effect was evident for all cytokines. summary/conclusions: using a time-and concentration-approach our findings indicate that sheep are more tolerant and have a delayed response to lps stimulation compared to previous research using similar human in vitro whole blood culture models. in addition, data suggest that sheep have greater immune responses using heparin as anticoagulant for the collection of blood samples. improving our understanding of sheep immunology and development of relevant sheep transfusion models will provide a bridge between sheep models of transfusion and clinical settings. . rhdig inappropriately administered (unnecessary exposure) (n = , %) administered to: -rhd positive woman (n = ) -rhd negative mother with rhd negative neonate (n = ) -woman with immune anti d (n = ) -administered in error (instead of other ig) (n = ) rhdig delayed/omitted/wrong dose (risk of sensitisation to the d antigen) (n = , %) -omitted (n = ) -delayed (n = ) -inadequate dose (n = ) administration without correct patient identification (n = , %) storage & handling (n = , %) failure to check the maternal and neonatal blood groups prior to administration was identified as a source of error. misinterpretation of blood results also led to women receiving product inappropriately. e.g. reading a negative antibody screen as the mother being rhd negative. patient identification was raised as an issue. rhdig is often stored in satellite blood fridges for easy access. collection from these areas did not always require confirmation against patient identifiers and there was no register of women who received product or link to the batch number to ensure traceability. two incidents involved the administration of rhdig when the prescription for other immunoglobulin products was not clear, leading to a child and a baby receiving rhdig instead of the intended immunoglobulin. summary/conclusions: these incidents indicate problems with the processes of appropriate identification of women who need rhdig, the use and interpretation of pathology tests and requirements for prescription and administration. these resulted in omitted and inappropriate doses of rhdig. blood matters has made a number of recommendations regarding rhdig administration: -all health professionals involved in rhdig administration should be appropriately trained in the use of rhdig -confirmation of the maternal rhd status is essential prior to prescription or administration -positive patient identification must be used prior to administration of rhdig -health services should consider regular auditing to identify areas for improvement relating to rhdig blood matters continues to work with maternity care providers to improve practice. centro comunitario de sangre y tejidos de asturias, oviedo agencia gallega de sangre, organos y tejidos, galicia banco de sangre y tejidos de cantabria, cantabria banco de sangre de la rioja, la rioja banco de sangre y tejidos de navarra, navarra banco de sangre y tejidos de arag on, aragon fundaci on de hemoterapia y hemodonaci on de castilla y le on, castilla y leon fundaci on banco de sangre y tejidos de las islas baleares, islas baleares, spain terumo bct europe nv, zaventem, belgium background: hemovigilance, a long-term monitoring process made mandatory by national and supranational regulations, begins with a systematic whole blood or blood component collection and ends with an examining period after transfusion of blood components into the patients. in spain, organized in autonomous regions, the hemovigilance system is structured in three levels: ( ) the local level comprised of transfusion centers and hospital based transfusion services that monitor and collect all transfusion related adverse events (ae) and level them up to ( ) the regional hemovigilance coordinator, who communicates all the region's data to the ( ) spanish ministry of health which issues an annual report and corresponds with european institutions. to ensure safer blood supply, pathogen reduction technology (prt) was approved and implementation started in spain in . the mirasol prt system for platelets and plasma was introduced in and is currently being used in of the spanish regions. aims: to monitor the safety of the system, a passive hemovigilance study on mirasol treated products was initiated in the region of asturias and collaboration was extended to other regions (baleares, galicia, la rioja, cantabria, navarra, castilla y leon and aragon). methods: collected data included allergic and febrile reactions, trali and all other adverse event observed. severity of the event and level on imputability of the transfusion were also assessed using the who grading scale. hemovigilance data of mirasol treated products (platelets or m-pc and plasma or m-p) are included from to as blood centers started to apply the technology in routine. results: increase adoption of the mirasol system is observed between , when , mirasol treated blood products were issued to hospitals and with , mirasol products issued. due to low number of transfusions of mirasol-treated blood components in and , notification rates began to be analyzed in , showing ae rates of . %, similar to reports at the national level. stable transfusion reaction rates were observed with m-pc (around . ). rate of ae after transfusion of m-p is fluctuant between . and . . this fluctuation could be due to the inconsistent numbers of m-p transfused from one year to the other. most of transfusion reactions (around %) were of grade i severity and grade ii level of imputability. allergic reactions accounted for most of the adverse events, with g&i > reactions in and of respectively . and . no bacterial nor viral transfusion transmission was recorded on mirasol products during the study period ( ) ( ) ( ) ( ) ( ) ( ) . at the national level, nine cases of bacterial transfusion transmission (with g&i > ) were reported. these transmissions were probably due to transfusion of non-pathogen reduced products. summary/conclusions: the observed notification rate of ae is similar to the national rate but allergic reactions with g&i > is inferior with mirasol treated products. also, we found no reports of transfusion transmission infections nor cases of transfusion associated graft-vs-host disease, demonstrating safety of mirasol treated products. were attributed to human error ( %) with the lowest frequency in equipment failure ( %), compared to % and %, respectively, in the following three years. root cause analysis demonstrated failures in the quality management system including failures in administration, inadequate staffing for blood collection as well as in distribution and processing, and failures arising from institutional constraints and system failures in hospital management. high numbers of "other" aes ( %) in distribution and whole blood collection call for further investigation to indicate measures necessary for prevention and correction. errors related to incorrect blood component transfused (ibct) in - were in , , blood units ( / , ) issued for transfusion. these resulted in serious reactions ( %) ( fatal, life-threatening) . another ( %) were related with ibct that did not cause a reaction. near misses (component not transfused) were ( %) summary/conclusions: our data demonstrate increasing compliance with reporting requirements. questions about the initial factors for deviations in certain activities specifying failures in equipment and materials due to system as well as human errors, highlight the need for further specifications beyond "other" and "human error". background: the weakest link in the transfusion chain currently is the handling of blood components after their issue and the bedside blood administration practices. aims: to evaluate compliance with standard procedures for bedside blood transfusion practices by analysis of the "transfusion feedback forms" in a tertiary care multi-specialty hospital setting. methods: during the study period of months, the transfusion feedback forms received from various clinical areas of the hospital were studied with special reference to the transfusion times. the data was categorized based on the patient's location as well as the time of transfusion, whether done in routine or emergency hours. results: , blood components were issued during the study period, while transfusion feedback forms for , components ( . %) were received in the transfusion medicine department. delay in starting the transfusion (more than min after issue) was observed in transfusion events ( . %). the component transfusion time exceeded the permissible limits for component ( . %).the overall total permissible time for completion of components exceeded permissible limit in ( . %) of transfusion events. the pediatric ward ( . %), icu and ot complex ( . %) were found to be the most non-compliant delay in transfusion, transfusion time and total transfusion time. amongst the delayed transfusions after issue, ( . %) were during the routine hours i.e. between am to pm and ( . %) were in the non routine hours i.e. between pm to am. summary/conclusions: the audit of bedside blood transfusion practices has given us a good insight into various areas of noncompliances as well as the predominant locations in the hospital where the practices need to strengthened further. focused training program on safe blood administration practices for all staff involved in handling and transfusion of blood components is now planned to combat this issue. background: the international surveillance of transfusion adverse reactions (ars) and events (aes) (istare) of the international haemovigilance network (ihn) collects aggregate data from member national haemovigilance systems (hvs) in order to estimate the morbidity and mortality of blood transfusion in a holistic approach. the ultimate goal is to contribute to improving the safety of transfusion by close monitoring throughout the chain "from vein to vein". aims: we analyse recent istare data on suspected transfusion transmitted infections (sttis) for - in comparison to previous years of surveillance, [ ] [ ] [ ] [ ] [ ] [ ] [ ] methods: annual aggregate data from ihn member hvs on transfusion associated bacterial, viral and parasitic infections collected online in istare are analyzed by incidence in blood components (bcs) issued for transfusion, by severity and imputability as well as by blood component. ars with definite, probable or possible imputability were included in the analysis. trend analysis is performed to allow comparisons and to collect information on established and newly emerging infectious threats of blood transfusion. results: for - sets of annual aggregated data from countries covering , , bcs issued were analyzed. all ars totalled , and infectious ars amounted to ( . %). the overall incidence of the infectious ars was . / , units of bcs issued. bacterial infections were the most frequent ( , %), next viral ( , . %) and then parasitic ( , . %). serious were % and there were fatalities ( . %, incidence . / , ). nine deaths were attributed to sepsis and the other two were associated with non-malarial parasitic pathogens. one geotrichum clavatum fungal infection associated with apheresis platelets was reported as a free text comment. this very rarely recognized fungal pathogen caused a very severe infection in a patient but the route of transmission is inconclusive. the viral sttis included hbv ( %), hcv ( %) and hiv ( . %). the recorded as "other" ( . %) including cases of hev, one case of parvovirus b , one cmv and one ebv. no case of tt-malaria was reported. other stt-pi were (two fatal). the prevailing bcs were in general rbcs followed by platelets. comparison with corresponding data for - shows a consistent overall incidence in total sttis ( . vs . / , ). however, considerable differences were seen in separate categories, such as bacterial infections (significantly increased rate in - , p < . ) and an almost doubled rate of parasitic infections (p < . ). compared to the earlier period, there were many fewer hbv infections ( vs ) and many more hev. a similar reduction in the rate of hcv and hiv was observed in - in comparison with previous years. this may be explained by the fact that nat testing for hcv/hiv/hbv has been implemented in many countries in the last decade. summary/conclusions: the infectious risk of transfusion overall remains very low. the rate of bacterial cases has increased and among other viral sttis the frequency of hev is increasing. the mortality of transfusion due to sttis is lower than in the previous period of surveillance. abstract withdrawn. background: one of the main aspects of haemovigilance system in hospitals is following of adverse events and reactions related to blood transfusions. aims: it was intended to analyse the adverse reactions related to transfusion of blood components in pediatric patients. methods: over a four year period (january -december ), the haemovigilance records of all patients receiving blood transfusions procedures were reviewed and transfusion reactions were analysed. statistical analysis of data was performed by spss software (version . , spss inc., chicago, il, usa). majority of blood components were provided by regional blood center organized by national red crescent society. but granulocytes collected by apheresis after donor mobilization and reconstituted whole blood for exchange transfusions were prepared in the transfusion center of the hospital. results: the median age of patients who developed transfusion reactions was months (interquantile range-iqr ). the median for the numbers of individual transfusions in children in a year was (iqr ). the median for the numbers of blood components individually transfused to patients was (iqr ). patients, anaphylactic transfusion reactions in patients and transfusion-related lung injury (trali) in a patient. the overall incidence of transfusion reactions was estimated at a rate of . per units. summary/conclusions: it was reported that adverse effects related to blood transfusion, especially allergic reactions and fnhtrs are common in pediatric patients than adults. in a multinational study concerned about the transfusion reactions related with red cell concentrates, allergic transfusion reactions and fnhtrs were reported at a rate of and in units and in units, respectively. while the incidence of transfusion reactions in children was found . % in a study from the u.s.a., the overall incidence of transfusion reactions in our study which was estimated at a rate of . per units represents a lower rate. hospital gran canaria dr. negr ın, gran canaria hospital general universitario, ciudad real, spain hospital nostra senior de meritxell, andorra, andorra banco sangre y tejidos, santander banc de sang i teixits, barcelona, spain fundaci on hematol ogica colombia, bogot a, colombia centro regional de transfusi on de almer ıa, almeria complejo hospitalario de navarra, pamplona fundaci on banc de sang i teixits illes balears, palma de mallorca hospital de cabueñes, gij on, spain background: root analysis cause is defined as the cause of an error that, if it is treated, eliminates the repetition of the error aims: describe types of human and latent errors detected by a work group in the root analysis cause of transfusion incidents, analyze the concordance between the individual responses of the members and propose recommendations in order to improve transfusional safety. methods: in fifteen participants (nurses and hematologists dedicated to transfusion and component preparation) studied some incidents of administration of nonirradiated components and tried to approach the root causes by applying the classification of errors in mers-tm transfusion medicine. they transferred the answers to a questionnaire (simple or chain error, initial process affected, human and latent errors and measures derived from the analysis to correct the errors). the communication was made by mail and by the spanish transfusion society web forum, which contained the consultation documents. data and percentages are exposed for each type of error and the answers of the participants are tabulated. results: cases corresponded to patients. two patients of years of age diagnosed of acute myeloblastic leukemia (case and ) and chronic lymphatic leukemia (case ). in one case, the hematologist of the transfusion service canceled an irradiation prescription; in another, a patient with fever was transfused in the emergency room without the irradiation requirement and it was later discovered that he had received a transplant of hemopoietic progenitors month earlier; in the last case, neither the requesting doctor nor the laboratory technician nor the following doctor (prescriber) detected the alerts located in their respective computer applications. in all cases, the story was judged as sufficient for analysis. the majority of reviewers ( %) diagnosed a chain of errors. there was agreement of % with respect to the initial process affected. the initial error was communication ( %), monitoring ( %) and compliance ( %), in cases , , and . - human errors were detected per case (average: . , . and . errors respectively) and - latent errors per case (average: . , . and . , respectively). the latent errors most punctuated were: failures in the quality of the protocols ( %), in the transfer of important knowledge ( %), in the available technology ( %) and in the information to the patient ( %). all the participants contributed feasible measures of improvement according to root causes: ) improve the quality and drafting of work procedures and their compliance, including procedures of effective communication between professionals, ) train staff in knowledge important for safety, ) communicate with computer application providers to improve the effectiveness and visibility of the alerts and ) involve the patient with essential information to ensure transfusion safety. the measures were processed later as recommendations. summary/conclusions: the root analysis shows agreement between participants and allows the elaboration of useful recommendations to increase patient safety. this strategy can contribute to the comprehensive prevention of errors. background: in transfusion-associated circulatory overload (taco), pulmonary oedema develops primarily due to volume excess. data from the uk haemovigilance scheme, serious hazards of transfusion (shot) suggest that either the incidence of taco, or the recognition and reporting of taco, has increased over time. from to , reports of taco increased from to ; deaths from to , major morbidity from to . known risk factors include pre-existing cardiac and/or renal dysfunction, low body weight, extremes of age (eg, < years, > years), concomitant fluid administration, positive fluid balance, peripheral oedema and hypoalbuminemia. in a small subset of cases reported to shot, taco developed following transfusion for severe anaemia in the absence of other risk factors. this may be an under-recognised independent risk-factor. aims: to raise awareness of severe anaemia as an under-recognised risk factor for taco and is potentially life-threatening transfusion. methods: cases of taco submitted to shot over the last years were reviewed to identify cases where transfusion for severe anaemia was a key identifiable patient risk factor. results: the following are illustrative cases: -case : a patient in their s weighing kg was prescribed six units of red cells for iron deficiency anaemia after being admitted with hb g/l. the patient had no risk factors for taco except for profound anaemia. during transfusion of the fifth unit the patient became dyspnoeic, hypoxic and hypertensive. the patient recovered after diuretic therapy and had a post-transfusion hb level of g/l. -case : a patient in their s presented with a -week history of weakness and dizziness and had felt unwell for months. the hb was g/l, ferritin lg/l and ecg showed cardiac ischaemia. two units of red cells were transfused. after the second unit oxygen saturations fell despite supplemental oxygen, post-transfusion hb of g/l. a third unit was transfused over min and the hypoxia worsened with dyspnoea and crackles on chest auscultation. the chest x-ray showed an enlarged cardiac silhouette and pulmonary congestion. the patient improved with diuretics. -case : a patient in their s with severe megaloblastic anaemia, hb g/l and peripheral oedema developed taco after transfusion of units and recovered with diuretic therapy. summary/conclusions: chronic and acute anaemia are associated with compensatory cardiac changes irrespective of the aetiology of anaemia. this is further compounded by the underlying cause of anaemia particularly haematinic deficiencies (iron/b deficiency) that independently affect myocardial function. hyperdynamic circulation related to anaemia increases the load on the heart, causing myocardial ischaemia and hypoxia and if the anaemia is not corrected, eventually leads to heart failure. clinicians need to make an accurate diagnosis and avoid excessive transfusion in patients with severe anaemia with or without other additional risk factors. patients with chronic iron/folate/b deficiency without haemodynamic instability should be given the appropriate haematinic replacement. haematinic deficiency responds rapidly to appropriate vitamin/mineral. blood transfusions are to be given only when clinically indicated and even then, only the minimum volume needed for symptomatic relief transfused with consideration for diuretic therapy. methods: legal forms for reporting transfusion reactions were used in the retrospective analysis, which were adjusted by the department of quality assurance and quality control in the electronic form and distributed to clinics using blood components. clinicians were trained to report transfusion reactions through the hospital's transfusion board and through the "service for improvement of the quality and safety of health services" at the clinical center of sarajevo. analysis of the reported reactions in the institute include immunohematological and microbiological examination based on which the guidelines for further treatment with blood components are being made. users of registered services are obliged to report since . results: total of , different blood components were applied in the period between - . department for quality assurance and control has received serious adverse reactions, serious adverse event, reports of transfusion reactions, of which ( %) were inadequately filled, in the same period. from the above, ( . %) were transfusion reactions to erythrocyte blood components which were applied, ( . %) to platelet components and ( . %) were transfusion reactions after the application of fresh frozen plasma. the analysis has shown that the most frequent were febrile non-haemolysis reactions ( or . %), followed by allergic reactions ( or . %). two transfusion reactions ( . %) were characterized as circulation overload. summary/conclusions: the frequency of serious adverse reactions and events was . % ( of , ) and . % were reported transfusion reactions ( of , ). with the establishment of the hospital transfusion board and with the increase of collaboration with the clinical center, significant progress has been made. it is necessary to increase awareness among clinicians in regards to the safe transfusion practice. reporting transfusion reactions should be a mandatory procedure, a path to the proper selection of blood components, monitoring adverse reactions, and for us, transfusiologist, guide to the safest, most efficient blood components. j garc ıa-gala, e martinez-revuelta, a caro-g omez, c castañ on-fern andez and i fern andez-rodriguez hospital universitario central de asturias, oviedo, spain background: elderly patients are the main group of transfusion recipients in our country. given their comorbidities are a risk group for the development complications related to transfusion. aims: analyze the incidence of adverse effects related to transfusion in the elderly population and to assess what factors may influence its appearance methods: transfusions were reviewed in patients > years old. the variables analyzed were: sex, age, diagnosis/reason for transfusion, pre-transfusion hemoglobin (hb), number of transfused units, infusion rate and transfusion side effects, as well as the measures used to prevent or treat the transfusions. effects of circulatory overload results: a total of patients were analyzed ( women, men), with a median age of years ( - ). in total, ch were transfused. patients received ch, patients ch, patients received ch. patients were transfused at two different times. the median hb prior to transfusion was . g/dl. in the patients who received ch was . g/dl, those who received ch: g/dl and those who received ch: . g/dl. the infusion time could be estimated in % of the patients. in those who received ch was . min; . min in those who received ch and . min in those who received ch. patients ( % of the total) suffered some type of adverse effect related to the transfusion. in patients there was an increase in posterior ta, in an increase in hr, in an episode of hypotension and in another one episode of acute respiratory failure. % of those who had an adverse effect were older than years. patients with aht after transfusion, % received ch and the remainder ch. among their background, % had a history of ischemic heart disease. % also had a positive balance. the average previous bp was / mmhg and the subsequent one was / mmhg. % of patients did not receive diuretic treatment. in the case of the patient with acute respiratory failure was in oligoanuria, with positive balances. ch was transfused in total. she was treated with oxygen therapy and with intensification of the diuretic treatment, recovering later. summary/conclusions: -patients > years have a higher risk of suffering some type of adverse effect related to transfusion because they have pre-existing risk factors such as ischemic heart disease or heart failure. -we see that the risk of suffering some type of adverse effect in the elderly population is greater when we transfuse ch than ch. -we have appreciated that in those patients receiving ch, the infusion rate is higher. -the study highlights the lack of methods to prevent the development of circulatory overload. background: iron deficiency anemia is the commonest cause of anemia worldwide. weakness, fatigue, reduced physical activity and difficulty in concentration are the symptoms which are associated with its deficiency. the forefront treatment available is oral iron replacement therapy which is convenient, cost effective and has substantial outcome. another option is intravenous (i/v) iron when oral is not tolerable. despite of potential transfusion associated hazards and limited availability of blood due to shortage of voluntary blood donations, it is insisted by the patients prior to iron therapy. aims: the aim of conducting this study was to observe the impact of administration of oral iron, i/v iron and transfusion on hemoglobin levels in patients presented with iron deficiency anemia. methods: this was an observational study carried out at nibd and bmt, pechs campus, karachi, pakistan from february to december . the study was approved by the institutional review board. diagnosed ida patients presented at our hospital were recruited for analysis who were given oral iron, i/v iron and transfusion for the correction of anemia. informed consent was taken from the participants. descriptive and inferential statistics was applied by using spss version . . results: a total of ida patients were analyzed in which ( %) were females and ( %) were males. the most common symptom in females and males was fatigue followed by body aches in females ( %) and pallor in males ( %). menorrhagia was present in ( %) of females of reproductive age. surgical history was present in ( %) of females while there was no surgical history in males. mean hemoglobin, mch and mcv of females at baseline was . ae . , . ae . , and ae . while in males it was . ae . , ae . and . ae . respectively. sixty two ( %) females were advised oral and i/v iron and ( %) received transfusion. however, in males ( %) received transfusion and ( %) were advised oral and i/v iron therapy. it was observed that the increment of hemoglobin after oral/iv iron at average of months follow up in males and females was same as that the transfusion (p > . ). summary/conclusions: in our society where blood donations are scarce especially voluntary blood donations that are considered to be the safest type of blood donation. we would like to draw attention towards the alternatives to correct anemia such as oral and i/v iron replacement therapy as our results revealed that there was no difference in the increment of hemoglobin between the two groups. we need to educate our society especially the older age adults and young women who are more vulnerable of getting ida to opt oral and i/v iron therapy. it will be cost effective, convenient and also has less risk than transfusion. cellular therapies -stem cell and tissue banking, including cord blood background: the differentiation of megakaryocytes plays an important role in the production of platelets. however, the underlying mechanisms regulating megakaryocytes differentiation have rarely been studied. aims: to identify candidate genes involved in megakaryocytes differentiation and investigate the potential regulatory mechanisms of megakaryocytes differentiation from human cord blood hematopoietic stem cells in vitro. methods: cb-derived cd + cells were isolated using density gradient centrifugation and magnetic activated cell sorting (macs). cultures were stimulated with only recombinant human tpo ( ng/ml). after , and days, the mk fraction was selected by immunomagnetic sorting from the non-mk fraction using an anti-cd a monoclonal antibody. rna-seq-derived gene expression data was performed on uncultured samples (day ), cultured but unselected samples (day ), and cultured, selected samples (day , and ) by using the next-generation sequencing (ngs) platform, and rq-pcr technology was used to verify the expression of transcription factors. results: the comparison of the transcriptome profiles among the five stages showed that a massive gene expression change occurred in megakaryocytes differentiation. a total of genes were detected, of which showed up-regulation and down-regulation. among these genes, differentially expressed genes (degs) (fold change ≥ ; false discovery rate < . ) were selected were further validated with rq-pcr, including gabre, cdhr , wasf , pkhd l , thbs , pf v , lrrc and lgals . the rq-pcr result indicated that the mrna expression level increased with the prolongation of culture time. however, pf v mrna expression level was highest at day , lgals was highest at day . summary/conclusions: conclusion: our study identified a series of genes that may participate in the regulation of megakaryocytes differentiation. these results should serve as an important resource revealing the molecular basis of megakaryocytes differentiation and thrombocytopoiesis. preoperative anemia and blood transfusion requirement during hip and knee surgery rambam health care campus, haifa, israel background: blood transfusion (bt) is independently associated with increased morbidity, mortality and hospitalization length across different patient populations. due to bt-related risks, the concept of "patient blood management" (pbm) has been introduced to clinical practice. the three pbm pillars are: optimizing red cell mass, minimizing blood loss and optimizing physiological reserve. bt indications during orthopedic surgery include excessive bleeding or hemodynamic instability and not the hemoglobin (hb) level. in most clinical scenarios, a restrictive transfusion threshold (hb level: - g/dl) appears to be non-inferior to the liberal transfusion strategy in terms of blood use, morbidity and mortality. similar results are observed in highrisk patients after hip surgery. we hypothesize that preoperative anemia may lead to blood product overuse and its complications. aims: evaluating potential correlation between preoperative anemia and bt requirement during hip or knee surgery. methods: we reviewed medical files of patients who underwent hip or knee replacement surgery at rambam between - . patients with hb level measurement within days pre-surgery were included. receiving > blood unit was considered a surgery complication and such patients were excluded. patient demographic and clinical data, including comorbidities, surgery type, length of hospital stay, were collected. we created a synthetic data cohort using mdclone healthcare data sandbox, an environment enabling fast data extraction and producing synthetic data for analysis that does not require irb approval. results: during the evaluated period, patients underwent hip or knee surgery; were excluded from the analysis due to receiving > blood unit. hb measurement within days pre-surgery was available for patients. hip or knee surgery was performed in ( %) and ( %) patients, respectively. women comprised % (n = ) of patients who underwent hip surgery. in the hip-surgery group, . % of patients required bt, with this need being slightly higher among women ( . % vs. . %; p-value=ns). only ( %) patients were transfused during knee surgery and this cohort was not further analyzed. patients receiving bt had a significantly lower mean hb level than those who didn't require it ( . g/dl versus . g/dl for women and . g/dl vs. . g/dl for men; p-value < . ). hospitalization was longer in transfused patients compared to non-transfused ones (mean . vs. . days, p-value = . ) and in patients with a low hb level (female < , male < . ) than in those with a high hb level, irrespective of receiving bt (p-values < . ). patients with at least one of the following diagnoses: diabetes, renal failure, ischemic heart disease, were significantly more likely to have a lower preoperative hb level (p-value < . ). no other factors (e.g., patient's weight, rdw value or blood pressure) were predictive of transfusion need. the probability of a need for blood unit was . in the hb g/dl group and . in hb g/ dl group ( %>reduction). summary/conclusions: anemia presence before elective hip surgery is a risk factor for bt requirement and longer hospitalization. diagnosis and management of anemia using timely pre-surgery consultations may minimize intraoperative bt, particularly in women and patients with comorbidities. real-patient data and prospective trials are warranted. abstract withdrawn. abstract withdrawn. background: cd , known as platelet glycoprotein iv, belongs to type b scavenger receptor and is related to the pathogenesis of many diseases. type i cd deficiency was cd not expressed on platelets and monocytes. individuals with type i deficiency can produce homologous antibodies and cause related immune diseases. in recent years, it has been reported that cd deficient individuals cause fetal immune thrombocytopenia with fetal edema syndrome in asia. cd is not expressed in mature rbc, but exists in hematopoietic stem (progenitor) cells. anemia is an important cause of edema. in view of the phenomena of clinical and animal experiments, cd + hematopoietic stem (progenitor) cells were cultured in vitro to observe the effect of anti-cd monoclonal antibody on cd + hematopoietic stem (progenitor) cells. aims: to investigate the effect of anti-cd monoclonal antibody on proliferation and differentiation of human cd + hematopoietic stem (progenitor) cells in vitro. methods: choose healthy full-term maternal women without various obstetric complications, take cord blood ml. after density gradient centrifugation of ficoll cell separation solution, cd + hematopoietic stem (progenitor) cells were sorted by flow cytometry and cultured for - generations. mtt was used to examine the effect of anti-cd monoclonal antibody on the growth of hematopoietic stem (progenitor) cells. flow cytometry analysis was used to detect the apoptosis and cell cycle of cd + hematopoietic stem (progenitor) cells. the effect of anti-cd monoclonal antibody on the formation of cfu-e/bfu-e in hematopoietic stem (progenitor) cells was analysis by cfu-e/bfu-e account after - days culture. results: after umbilical cord blood was isolated by ficoll to obtain mononuclear cells, the hematopoietic stem (progenitor) cells of cd + were sorted by flow cytometry, and about . % of cd + hematopoietic stem (progenitor) cells were isolated. different concentrations of anti-cd monoclonal antibody and hematopoietic stem (progenitor) cells were cultured in vitro. the od value of value ( . ae . ) of anti-cd monoclonal antibody group ( mg/ml) was decreased than normal group ( . ae . ) (p < . ), and the od value ( . ae . ) was significantly decreased at the cd monoclonal antibody concentration of mg/ml (p < . ). there was no significant difference between the hematopoietic stem (progenitor) cells culture group and the igg control group (p > . ). in the annexin v flow detection, the apoptotic rate of anti-cd monoclonal antibody group ( mg/ml) was statistically increased than the normal group (p < . ). anti-cd monoclonal antibody significantly induced hematopoietic stem (progenitor) cells to undergo s phase cell reduction, g phase cells increased, and g /s phase cell arrest occurred. the number of cfu-e/bfu-e clones in the normal group was ae , the number of cfu-e/bfu-e clones in the control group was ae , and the number of cfu-e/bfu-e clones in the anti-cd monoclonal antibody culture group was ae . the number of colonies formed by hematopoietic stem (progenitor) cells in the anti-cd monoclonal antibody culture group was significantly lower than that of the other groups (p < . ). summary/conclusions: anti-cd monoclonal antibody can reduce the proliferation of human cd + hematopoietic stem (progenitor) cells and reduce the ability of erythroid differentiation. background: recently the new modern collection techniques were introduced in the apheresis procedures. cobe spectra system was replaced with spectra optia, and it was necessary to verify the efficiency of spectra optia in pbpc collections. aims: the aim of the study was to evaluate and optimize the new cmnc protocol spectra optia v. (terumo) for pbpc collections in patients with haemato-oncological malignant diseases. methods: the results of autologous pbpc collections were evaluated in: (a) well mobilized patients with precollection cd + cells concentration in blood higher than /ll, (b) from only the first collections, which were performed either by the use cmnc spectra optia v. or cobe spectra v. , v. , terumo (c) collections were performed in the standard and large volume leukapheresis regimen, lvl. engraftment data in transplanted patients were assessed. results: standard collections were performed in patients. the yield of cd + cells was high, and no significant differences were found between the numbers of cd + cells prepared from spectra optia , ( , - ) and cobe spectra , ( , ) /kg b. w. (a = , ; pval , ). the dependence of cd + cell yield on the precollection concentration of cd + cells in blood can be considered as linear with high correlation coefficients in cmnc spectra optia r = , , and cobe spectra r = , . lvl collections were performed in of patients, and there were no significant differences between the numbers of cd + cells prepared by cmnc spectra optia , ( - , ) and cobe spectra , ( , - ) /kg b.w. (a = , ; pval , ). the relations between the precollection cd + cells concentration in blood and the numbers of cd + cells from collections can also be considered as linear with the correlation coefficients in cmnc spectra optia r = , , and cobe spectra r = , , respectively. in lvl, the median platelet loss was significantly lower in cmnc spectra optia ( %) than in cobe spectra ( %). a group of patients was transplanted by means of pbpc prepared in the standard regimen. median time in the neutrophil reconstitution was in cmnc spectra optia as well as cobe spectra days, while in platelets from cmnc days, and from cobe spectra days, respectively. the number of patients obtained pbpc from lvl. the median time in neutrophils and platelets reconstitution was in cmnc spectra optia as well as cobe spectra the same, and corresponded with and days, respectively. summary/conclusions: cmnc protocol spectra optia is a modern, efficient and the safe system, which can be used for both standard and lvl procedures. in well mobilized patients the sufficient dose of cd + cells for transplantation could be prepared from one standard or one lvl procedure. no serious adverse reaction have been observed. background: peripheral hematopoietic stem cells are collected from patients/donors after mobilization with g-scf. the aim of the collection is a fixed number of cd + cells/kg. this number depends on the pre-apheresis cd + number, the blood processed and the collection efficiency of the procedure. the aim should be to collect all the requested cells in day, whenever possible. this is in order to reduce the dose of g-csf given to donor/patient and the resources used in the collection centre. the only parameter that can be adjusted is the volume of blood processed, if this is increased, the likelihood of collecting the requested amount of cells is increased, but only if the pre-apheresis cd number is high enough. therefore, you need to know, when it is feasible to increase the volume and thereby increasing the time of the procedure with the intention to collect all the requested cells in day. it can also show if it is possible to reduce the volume of blood processed, thereby reducing the time of the procedure. aims: to develop an easy tool to calculate the volume of blood processed in order to collect the requested cells in day. methods: the mean collection efficiency (ce) was calculated. ce is calculated as cd + cells collected/(pre-apheresis cd + number*processed volume)* %. based on the mean ce, an excel sheet was generated to calculate the volume of blood that should be processed in order to collect all the requested cells. the excel sheet is designed so the user enters the pre-apheresis cd + number, patient weight and the requested number of cd + cells. the ce is fixed according to the mean ce calculated. the result is the volume of blood processed in order to collect the requested yield. based on that result, the apheresis machine will provide time for the procedure, thereby it is possible to evaluate if the collection can be finished in day or not, e.g. by increasing the volume of blood processed. spectra optia â was used for all collections, cmnc for allogeneic donors and mnc for autologous patients. results: mean ce = % (n = ). a ce of % was chosen as the cut-off for the cd calculation tool. using the cd calculation tool: allogeneic donors (n = ): mean ce = %, mean blood volume processed = . tbv, mean time: min, donors were finished in day collection ( %) autologous patients (n = ): mean ce = %, mean blood volume processed = . tbv, mean time = min, patients were finished in day ( %). the calculation failed in only case ( . %). in this case the volume of blood processed was reduced according to the calculation, but because of unexpected low ce, the requested number of cells was not achieved. summary/conclusions: the cd calculation tool based on an excel sheet has shown to be simple and easy to use in order to personalize the stem cell collection. immunotherapy products: blood product, pharmaceutical, or a new category all together? from till . all donors were hla typed and matched; they were fully informed on the donation procedure and signed an informed consent for donation. minimum dose required to ensure successful and sustained engraftment was /kg cd + cells and /kg mono-nucleated cells (mnc). pbsc harvesting was performed with continuous flow cell separator baxter c , cobe spectra and spectra optia using conventional-volume apheresis processing the - . total blood volumes per apheresis. a femoral catheter was used for harvesting and acid citrate dextrose formula a is used for anticoagulation. recombinant human granulocyte colony-stimulating factor (g-csf) is used to mobilize pbpc for collection. harvesting of pbsc is usually performed after to days of g-csf subcutaneous administration at a dose of lg/kg body weight. results: all the donors were siblings of the patients treated at the university hematology hospital. there were apheresis procedures performed in healthy sibling donors. there were males and females, aged - . one to two apheresis procedures were required to collect adequate graft. the single procedure usually took - h and the volume of collected stem cells was - ml. the needed number of mnc and cd + cells was successfully collected by . apheresis. there were abo incompatible donors. procedures for mobilization and collection of pbpc from healthy donors are generally well tolerated. the only adverse effects of the apheresis procedure were bone pain as reaction of g-csf and numbness of the extremities as reaction of acd-a (hypocalcemia), which occur rarely and were very mild. the collected pbsc were used in allogeneic stem cell transplantation in patients with: acute myeloid leukemia - patients ( . %), acute lymphoblastic leukemia - patients ( . %), chronic myeloid leukemia - patients ( . %), myeloproliferative disorders - patients ( . %), myelofibrosis - patients ( . %), severe aplastic anemia - patient ( . %), non-hodgkin lymphoma - patient ( . %), multiple myeloma - patient ( . %), chronic lymphoblastic leukemia - patients ( . ), hodgkin disease - patient ( . %). summary/conclusions: the apheresis collection of pbsc in healthy donors is an effective and safe procedure. we are developing our national stem cell donors registry as a part of bone marrow donors worldwide. in that way we hope we will help widen the world network of stem cell donors and enlarge the possibility for each patient to find the right match. background: leukocyte-removing filters for blood are being used widely as a universal leukocyte reduction policy is being adopted progressively throughout the world. filtration is one of the most effective methods for preventing various adverse transfusion effects caused by leukocytes included in blood components, such as febrile reaction, alloimmunization, and transmission of leukotropic viruses. aims: the goal was to evaluate whether the new domestic blood filter finecell, developed by kolon industries, gumi, korea, is appropriately suited to the international standards. and to reveal its efficacy and safety in the settlement of leukocyte reduction system in korea. methods: thirty-two units of packed red blood cells obtained from ml whole blood collected from healthy donors were used. this was done by analyzing the filtration time, residual leukocyte count, rbc recovery, and hemolysis rate during a storage period of days after leukoreduction. results: the standards commonly used for the evaluation of leukocyte-removing filters are set by the food and drug administration of the usa and the council of europe. the results of our study satisfied these international standards. summary/conclusions: the newly developed domestic leukoreduction filter was, thus, found to be efficient and will contribute to the improvement of the quality of isolated blood components used in korea. faculty of science, humanities and education, technical university of liberec, liberec, czech republic background: as polymeric fibrous scaffold fabrication techniques strive to create structures that more closely replicate tentative extracellular matrix form and function, the need for increased scaffold bioactivity becomes more pronounced. the fibrous structure made from biocompatible and nontoxic polymers ensures mechanical stability, however cell proliferation requires further stimulation. platelet-rich plasma, which has been shown to contain over bioactive molecules, has the potential to deliver a combination of growth factors (gfs) and cytokines capable of stimulating cellular activity. aims: the presented work deals with the preparation of nanofibrous materials with platelet growth factors incorporated into the internal fiber structure. polyvinyl alcohol (pva) was used for the preparation a material providing a progressive release of native gfs without need of subsequent crosslinking. methods: materials were prepared from pva (mw , , % of hydrolysis) using electrospinning technology (nanospider tm ws u). platelet lysate (pl) was prepared from thrombocyte rich solution (obtained from regional hospital in liberec, the concentration of - x plt/ml, freeze-thaw method with subsequent centrifugation). nanofibers were electrospun from % pva solution using water: ethanol ( : ) solvent system. materials with proteins were electrospun from solution containing % of pva and % of pl. morphological analysis was performed by scanning electron microscopy. protein release was monitored using spectrophotometry (bradford method) and chromatography. results: the prepared fibrous materials consisted of random oriented end-less fiber with smooth surface with minimal defects in structure. the morphology of materials was not altered by the addition of proteins. the average fiber diameter was: ae nm for pristine pva fibers and ae nm for pva with incorporated proteins (pva/pl). pva/pl layers contain - mg of protein per gram of pva. % of the proteins are released during the first day (burst release) followed by a gradual release of up to weeks. summary/conclusions: nanofibrous pva-based nanofiber materials were prepared with native growth factors. the process used for the preparation of solutions and subsequent spinning does not affect the activity of the incorporated proteins, which are being gradually released. therefore, we believe that the developed material has great potential for use in tissue engineering e.g. to promote healing of chronic wounds. acknowledgements: supported by the czech health research council, project no nv - - . background: human a-defensins are small cationic peptides with antimicrobial and anticancer activity. up till now, six a-defensins have been described in humans. they include the human neutrophil peptides (hnp) , and which present in large amounts in neutrophil azurophilic granules and differed from each other only in the first amino acid. a fourth defensin, termed hnp- , comprises less than % of the total defensins in neutrophils and has a distinct sequence from hnp - . the other two, human defensin and , are synthesized mostly by intestinal paneth cells. neutrophil defensins (hnp - ) are . kda peptides that are characterized by three disulfide bridges. the pattern of disulfide bonds in the mature forms is crucial for the functional properties. due to this structural feature, synthesis of defensins using the chemical and recombinant approach presents quite a challenge. moreover, purification from the natural source can be very difficult because the large number of neutrophils is needed to obtain a sufficient amount of protein. in blood banks, leukocyte reduction filters are used to remove leukocytes from blood components in order to prevent adverse transfusion reactions. leukofilters contain high numbers of normal human cells and discard after use. aims: the aim of this study was to purify a-defensins from neutrophils trapped in leukocyte reduction filters. methods: blood bags from healthy blood donors were collected after written consent. all donors were screened for infectious diseases (hbv, hcv and hiv) and negative samples were included in the study. blood bags were filtered at °c by leukoflex lst- filters. the cells were extracted from the filters by back-flushing with cold phosphate buffered saline (pbs), ph . , without mgcl and cacl , containing mm edta and . % sucrose. the pbs was homogenized with the filter content and then collected in a sterile tube. neutrophils were separated from mononuclear cells by ficoll. isolated neutrophils resuspended in pbs x at a concentration of cells/ml. for degranulation, cells were stimulated with nm of formylmethionyl-leucyl-phenylalanine (fmlp) for min followed by stimulation with lm of cytochalasin b for min. supernatant was collected by centrifugation at g for min. supernatant was incubated with mouse monoclonal antibody to hnp - and purification of hnp - was performed by lmacs protein g microbeads system. the presence of protein was confirmed by western blot. results: the presence of the . kda band was confirmed by western blot, which corresponded to the size of the a-defensins. summary/conclusions: the development of defensins as therapeutic products requires access to a steady supply of neutrophils. our results indicated that lst- filters are economical source for purifying a-defensins. anatomical sciences, abadan school of medical sciences, abadan, iran background: epigenetic reprogramming of terminally differentiated cell can modify somatic cells to a pluripotential state. there are several approaches that induce pluripotency in somatic cells. exposure the cells with the embryonic stem cell extract is an easy way, and some investigations were done on fibroblast cell line. however, its efficiency was low aims: the purpose of this study was to increase the number of reprogrammed granulosa cell as a full differentiated cell into pluripotential state methods: the human granulosa cells were cultured in the medium containing -aza-deoxycytidine and trichostatin a. then, the cells were exposed to mouse escs extract and co-cultured with mouse embryonic fibroblast in the presence of leukemia inhibitory factor (lif). alkaline phosphatase test and also immunohistochemistry staining for oct , sox and nanog were performed after and h and week results: the results indicated that after h the granulosa cells were revealed a round and expanded morphology. the cells in all groups except in negative control, were showed alkaline phosphatase activity. the cells that were cultured in medium containing -aza-deoxycytidine and trichostatin a and exposed to the extract had the most numbers of alkaline phosphatase positive cells. immunocytochemistry showed the granulosa cells that were cultured in medium containing -aza-deoxycytidine and trichostatin a with extract expressed oct with weak intensity after h. no expression of oct , sox and nanog were observed in other groups at the same time. after h, oct , sox and nanog were over expressed in the cells that were treated with -aza-deoxycytidine, trichostatin a and extract. furthermore, there was high expression of oct in the granulosa cells that were cultured in medium containing dmso and exposed to the extract. after one week, the expression of oct and sox in the granulosa cells that were cultured in medium containing dmso and exposed to the extract was continued while its expression ceased in the other groups. the expression of nanog were ceased in all groups after one week summary/conclusions: present study revealed that the inhibitors of the methyl transferase ( -aza-deoxycytidine) and histone deacetylase (trichostatin a) could delete the epigenetic markers and improved cells reprogramming by administration of the extract abstract withdrawn. abstract withdrawn. abstract withdrawn. background: mesenchymal stem cells (mscs) are adherent spindle shape cells expressing different surface markers. they show special criteria including, paracrine effects, differentiation to several tissue cells, migration, immunomodulatory and regenerative potentialities. mscs are isolated from different sources and employed as therapeutic tools to treat several diseases and injuries. however, some of mscs properties including secretion of growth factors and migration ability are controversial especially during remission or in presence of tumor. interestingly, msc-derived compartment could be used as practical tools in term of diagnosis, follow up, management and monitoring of disease instead of intact mscs. exosomes are kind of extracellular vesicles (evs) characterized via their size and releasing mechanism. usually they defined as less than nm in diameter vesicles. they secreted from different cells and are also found in urine, blood, breast milk, cerebrospinal fluid and other body fluids. exosomes contain genetic material including dna, mrnas, micrornas (mirnas) and other biomolecules. mirnas are single stranded non-coding rnas transcribed from dna. immature mirnas are subjected to two known cleavages to modify to mature mirna that involve to either mrna degradation and gene expression process or cell-cell interaction and communication via secretion as the part of exosomes. aims: this study was aimed to discuss some aspects of exosomal micrornas derived from mscs in progression, diagnosis and treatment of some diseases. methods: different scientific data bases including pubmed, google scholar and scopus were used to find and review related articles. results: evs play important role either in intercellular communication related to pathological and physiological situation or intracellular communication, angiogenesis, immune system modulation and metastasis progression. mirnas could regulate expression of multiple mrnas then they play important role in different biological processes and contribute cell-cell interaction as well as influence in the progression of different disease. exosomal mirna-derived mscs are involved in cancer procession, tumor growth, angiogenesis and metastasis. they are used as diagnosis and therapeutic tools to treat different diseases such as renal failure, liver fibrosis, myocardial infarction. summary/conclusions: due to controversial aspect of using of intact mscs especially during remission or in presence of tumor, msc-derived exosome could be used as practical tools in term of diagnosis, follow up, management and monitoring of disease instead of intact mscs. aims: the aim of study try to use sybr green i based real-time pcr to identify homozygous, heterozygous, gene deletion or wild type for rhd exon , , and a. methods: for this study, we used real-time pcr with high resolution melting curve mode, and matrix mix containing sybr-green i were used for sequence specific primers of g>a and rhd exon , , . samples with rhd gene deletion homozygous/heterozygous, g>a heterozygous with rhd gene deletion and normal rhd, normal rhd homozygous/heterozygous and rhd -rhce( - )-rhd homozygous/heterozygous were enrolled in our study. all samples were screened using rhd exon genotyping, sanger sequencing and rhesus box analysis. concentration and mass of dna samples were in alleles of normal rhd/rhd gene deletion. the tm ratio of rhd exon ( °c) to internal control ( °c) were . in alleles of normal rhd/rhd -rhce( - )-rhd , . - . in alleles of rhd gene deletion/normal rhd, . - . in alleles of normal rhd and < . alleles of rhd gene deletion. the tm ratio of rhd exon ( °c) to internal control ( °c) were . in alleles of normal rhd/rhd -rhce( - )-rhd , . - . in alleles of rhd gene deletion/normal rhd, . - . in alleles of normal rhd and < . alleles of rhd gene deletion. the tm ratio of rhd exon ( °c) to internal control ( °c) were . in alleles of normal rhd/rhd -rhce( - )-rhd , . in alleles of rhd gene deletion/rhd -rhce( - )-rhd . - . in alleles of rhd gene deletion/normal rhd, . - . in alleles of normal rhd and < . alleles of rhd gene deletion. summary/conclusions: using the tm ratio of sequence specific primers to internal control is an effective way to detect the rhd gene deletion or rhd weak d types , and not detected") were tested with a method based on next generation sequencing (ngs) using the illumina miseq platform to detect a possible rhd variant not interrogated by id rhd xt. results: in total dna samples were tested in pools. fifteen ( ) pools ( samples) gave rhd deletion genotype and seventy two ( ) pools ( samples) resulted to the presence of rhd gene. the positive pools were also analyzed individually. the genotype results obtained were: rhd exon no amplification ( ), rhd exon and the genotype results obtained with id rhd xt (in pools and individually) were concordant with the results provided by the centers. hence, % accuracy was obtained using id rhd xt with dna pooled samples. the results of rh ngs for the samples with inconclusive results by id rhd xt showed rhd variants previously described: sample rhd* - inst (del), sample rhd*ivs + g (del), samples rhd*weak d type (partial d), sample rhd*weak d type (weak d), sample rhd*weak d type (weak d) and not described: sample rhd*del - (unknown) summary/conclusions: id rhd xt is a high accurate tool for genotyping the most common rhd alleles associated to weak d and d negative phenotype in up to pooled dna samples. use of rhd genotyping improve rhd typing in blood donations variant rhd alleles generate qualitative/quantitative alteration in serological expression of d antigen such as weak and partial rhd phenotypes which are clinically important in transfusion setting. population studies have shown varied distribution of the variant d alleles in caucasians, africans, east asians and indians. many countries have developed their own population-specific strategy for identifying d variants. our previous study in indian population showed absence of weak d type , , and which are commonly found in caucasians d variant individuals. instead, a novel population-specific pattern i.e.~ -kilobase duplication event, including exon , was predominantly identified in . % d variant samples. functional analyses showed that this genetic variation results in the expression of several transcripts, including a wild-type product. commercial genotyping assays available, mainly detect common d variants found in caucasians and africans, thus limiting its usefulness in india. hence, based on our findings we have designed a multiplex pcr assay specific for indian population that can be easily implemented at the laboratory level for genotyping variant rhd. aims: to characterize rhd variants using "indian-specific, rhd genotyping assay". methods: seventy samples referred to our laboratory for molecular characterization of rhd variants were included in this study. all rhd variant samples were serologically typed for results: out of the rhd variants included in this study, samples ( %) showed presence of indian specific allele i.e. exon duplication. seventeen rhd variants samples showed presence of both exon and . qmpsf analysis of these samples excluded involvement of rhd-rhce-rhd hybrids. sixty of the seventy d variant individual had r r genotype this assay thus can be used routinely in indian laboratories to identify and characterize rhd variants. - non-invasive fetal kel genotypes from allo-immunized anti-kel women were done ( positive confirmed fetuses, undetermined, positive non-confirmed, negative non-confirmed and negative confirmed). - non-invasive fetal rhc genotypes from allo-immunized anti-rh women were done non-invasive fetal rhe genotypes from allo-immunized anti-rh women were done ( positive foetuses, undetermined for , % of the allo-immunized women, the pregnancy was compatible and no specific antenatal monitoring was necessary summary/conclusions: non-invasive fetal red blood cell genotype is a powerful tool to diagnose a feto-maternal red blood cells incompatibility and allows to legitimize a costly and heavy specific antenatal monitoring s purchla-szepioła , m krzemienowska , m pelc-kłopotowska , m jurkowska , m debska , m uhrynowska and e brojer the test developed by ihtm has been offered to clinicians and pregnant women since but it is not covered by the health care system. rhd nipt is not informative for mothers with rhd variant. in such cases further analysis of the molecular background is offered to exclude from immunoprophylaxis the women with weak rhd type , and . aims: summary of a -year period of routine rhd nipt available at ihtm. methods: cffdna isolated using easymag, biomerieux from plasma of pregnant women determined with standard serology as rhd-negative (in - week of gestation) was examined for the presence of exons and of rhd and ccr by realtime pcr using lc ii (roche). maternal dna from whole blood was tested for identification of rhd variant using rbc fluogene rbc-dweak/variant (inno-train, germany) or the home-made protocol. results: in cases the rhd gene was not detected in cffdna and the administration of rhig was not recommended. in seven cases ct-values for rhd and ccr indicated a maternal d variant (d ct ccr -rhd > ); the genetic follow-up of six of them identified: rhd* w. in cases, rhd* w. and rhd* . in cases the rhd nipd results indicated that a fetus is rhd positive and rhig administration was recommended it was recommended in the remaining % of mothers. in . % cases with maternal d variant rhd nipt was not possible. however, in / such cases the test is unnecessary because follow up analysis revealed maternal rhd variant of the weak d type and in switzerland extended antigen-matching for duffy, kidd and mnsbesides rhesus and kell -is recommended for sickle cell disease (scd) patients. the ethnic diversity of red blood cell (rbc) antigen polymorphism engender that these patients are often transfused with rbcs from donors of african origin. this strategy, however, increases the likelihood of being exposed to certain low-prevalence antigens, such as rh (d w ), as these are almost exclusive to african populations. rh is encoded by several types of rhd*dv as well as by dau- . anti-rh is associated with delayed hemolytic transfusion reactions (htr) aims: here we report a specific low-prevalence antibody newly formed by the same patient, meanwhile gravida , para , causing positive crossmatches with the rbcs of two of the four selected donors. subsequently, advanced serologic and genetic workup and close international collaboration enabled optimal patient care. methods: standard serological methods were used for antibody specification (biorad, cressier, ch and in-house). crossmatches were carried out by indirect antiglobulin test at °c. molecular typing of donors' and parental blood group antigens was performed by further serological analysis (institute national de transfusion sanguine, paris) revealed an anti-rh in addition to anti-fy , anti-e and anti-jk a . genotyping of the two donors causing positive crossmatches presented heterozygosity for rhd* . which encodes rh . the newborn's phenotype was a r r k-, fy(a-b+) and most likely rh -and jk (a+b+), considering both maternal and paternal (a r r, k-k+, fy(a-b+), jk(a+b-), rh -) predicted phenotypes. the neonatal serum contained maternal anti-a , anti-rh and anti-e. the direct antiglobulin test was positive but elution only showed nonspecific reactions with papain-treated cells. latter might have been caused by anti-fy during her present pregnancy we were able to demonstrate that two positive crossmatches of two former compatible donors were caused by a new alloantibody against a low-prevalence antigen, namely anti-rh , derived from several rh + rbc transfusions during the previous pregnancy. despite this challenging blood supply we were able to support the patient with a total of ten antigen compatible and crossmatch negative rbc units from french and swiss donors until delivery with increasing age, the relative number of women in the study population raise from % in the patients younger than years to % in the patients older than years. our study showed that cardiovascular diseases were the commonest indications for warfarin use in older patients with %. only , % achieved target therapeutic range while the risk of thromboembolism and the subsequent need for proper anticoagulant therapy increases sharply with age, the bleeding risk rises as well. older patients are more sensitive to any given dose of warfarin and need a significantly lower total weekly dose. a well-informed patient provides one of the best defenses against bleeding complications. recent data demonstrate doacs advantages over warfarin, especially for older population: more predictable dosing, fewer drug interactions and reduced risk of intracranial bleeding although vast majority of fh cases are caused by mutations in ldl-r gene %- % patients do not harbor genetic cause in the known loci. patients with homozygous/severe heterozygous fh are unresponsive (ldlc above mg/dl with diet and drug therapy) and require additional extracorporeal therapy to reduce ldlc concentrations to prevent the development/progression of cad. ldl apheresis techniques remove apolipoprotein b-containing lipoproteins from blood and include heparin-induced extracorporeal ldl precipitation(help), immunoadsorption, dextran-sulfate adsorption methods: a y iraqi male visited cardiac-opd. ct coronary angiogram showed cad-dvd. he had multiple tendinous xanthomas and xanthelasmas. family history was significant for death of elder brother from coronary event at y, a sister with similar profile age y and one sister apparently normal. he was taking medical treatment for dyslipoproteinemia (ecosprin mg od, ticagrelor mg bd, rosuvastatin mg od). despite dietary and medical treatment his dyslipoproteinemia was refractory. therefore cascade-filtration was planned with evaflux a plasma fractionator. one procedure of cascade plasmapheresis was done on com.tec apheresis system (fresenius kabi, germany) separating patient's plasma as the first step and passing it through a pore sized based filter column a (evaflux, kawasumi, japan) as the second step. a total of . x plasma volume( ml) was processed. the patient was given continuous calcium infusion. the flow rate of ml/min was maintained immunoglobulins) were not assessed. summary/conclusions: the procedure successfully met the requirement of reduction of cholesterol by %. the patient became responsive to the medical treatment. follow up of the patient up to a year has been uneventful with no additional procedure requirement actions included development of major haemorrhage protocols with improved communication and required instances of delayed transfusion to be reported to the uk national haemovigilance scheme (serious hazards of transfusion, shot) methods: delayed transfusion data have been collected from . hospitals identify incidents and report them via an online database. mh may also result in avoidable or overtransfusion. reports are analysed and collated data published in the shot annual reports in july each year. results: the total number of reports of delayed transfusion has increased with time: , , in the last years. delayed transfusion in relation to mh was reported for cases - contributing to death in patients %) miscommunication was noted between clinical different teams, between emergency departments, porters and the transfusion laboratory, failure of bleeps, failure to communicate the urgency, failure to confirm the patient location. failures to follow mhp correctly occurred in / ( . %): incorrect activation including failed alerts to porters, wrong contact telephone details and wrong components in the mhp packs most transfusions included red blood cells (median, units); % of women were transfused with fresh frozen plasma (median, units) and % with platelets. mean pre-and post-transfusion hemoglobin levels were . g/dl and . g/dl, respectively, representing an increment of . g/dl per rbc unit transfused ( . g/dl in soweto and . g/dl in durban). indications for transfusion included obstetric hemorrhage ( %), chronic anemia ( %), surgery or anesthesia ( %), other ( %) and not specified ( %). transfusion for chronic anemia (vs. hemorrhage) was associated with gestation ≥ weeks (odds ratio = . , % confidence interval . - . ). surgical blood loss was a common indication in trimester ( %) that declined to % then % in trimesters and . summary/conclusions: hemorrhagic complications accompanying spontaneous abortions and ectopic pregnancies in the first and second trimesters were the most common reasons for antenatal transfusion surveillance and analysis of blood transfusion reactions represents inseparable part of hemovigilance. aims: summarization of data on reported cases of transfusion reactions. methods: analysis of serious undesirable reactions to blood products administration in the czech republic (cr) during period - . results: there were evaluated , of blood products administrations in , patients in the cr during defined three years period. announced , ( , %) transfusion reactions including severe transfusion reactions ( adjudged with grade ). the most frequent types of severe transfusion reactions: anaphylaxis , trali x, taco x, hcv x, hbc x, bacterial infection x, delayed hemolysis x. transfusion reactions incidence according to administered bp: red blood cells products: , administrations, transfusion reactions (fnhtr x, allergy x, circulatory overload x, anaphylaxis x, trali x, hbv x, hcv x) platelets: , thrombocyte administrations, including transfusion reactions (allergy x, fnhtr x, anaphylaxis x, circulatory overload x, delayed immune hemolysis x, acute circulatory overload x. granulocytes: administrations, transfusion reactions plasma: , administrations, reactions reported (allergy , fnhr , circulatory overload , anaphylaxis x, trali x, hbv x, ards x. summary/conclusions: conclusions: comprehensive analysis and data processing help to appropriate prospective setting of blood products (bp) production and hemotherapy. concrete outputs from processed data triggered undermentioned changes in many departments in the cr: . plasma for clinical uses from male blood donors, . prestorage of leucocyte reduced blood products, . production of platelets in additive solutions, . implementation of pcr testing method for blood donors screening. background: skae's basic activities include epidemiological surveillance of all adverse events (aes) associated with deviations in the collecting, testing, processing, storage and distribution of blood and blood components that may affect quality and safety near misses" and "uneventful transfusion errors" are collected to identify preventable causes. incorrect blood component transfused (ibct) events are reported following ihn instructions. results: a total of they were mainly associated with deviation in processing ( . %) and attributed to equipment failure and materials ( %) whole blood collection, materials and distribution, as a result of product defect, equipment failure, human error and other. trend analysis showed a significantly increasing (p < . ) annual rate of total aes by % ( % confidence interval - ) ) % fibrinogen-depleted phpl or ( ) % fibrinogen-depleted phpl plus heparin. internalization of fluoresceinamine-labeled heparin in stcs was investigated by flow cytometry and immunocytochemistry. all stromal cells were subjected to whole genome expression analysis (affymetrix human gene . st array) and data were analyzed using r/bioconductor and panther analysis tools. confirmative qrt-pcr was performed and protein levels of selected pathways were analyzed by a bead-based western blot system (digiwest â ). immunophenotyping, in vitro differentiation, longterm proliferation and colony forming units (cfu) assays were done for all cell types. results: in vitro exposure of heparin induced differential internalization and lysosomal accumulation in stromal cells, as well as regulation of distinct gene sets, both in a tissue-source dependent manner. affected signaling cascades were mainly involved in proliferation, cell adhesion, apoptosis, inflammation and angiogenesis. the influence of heparin on protein expression and phosphorylation of four pathways (wnt, pdgf, notch and tgfbeta) was further analyzed, revealing most alterations in bm-stcs. independent of origin and medium composition, flow cytometry analysis revealed the characteristic fibroblastoid phenotype profile (cd +/ +/ + and cd -/ -/ -/ -/hla-dr-). in addition a comparable osteogenic and adipogenic differentiation capacity was found summary/conclusions: internalization of heparin in lysosomes by stromal cells, differential gene and protein expression and phosphorylation changes were observed in a tissue-source dependent manner. however, stromal cell characteristics as immunophenotype pattern, long-term proliferation, clonogenicity and in vitro differentiation were unaffected, putatively by post-translational protein modifications. in this respect, application of porcine heparin is compatible with efficient manufacturing of stromal cell based medicinal products abo incompatibility may have no effect on the clinical outcome after allogeneic hematopoietic stem cell transplantation. however, it carries additional risks of hemolytic reactions, delayed red blood cell (rbc) engraftment and incidence of graft-versus patients were categorized according to abo compatible and mismatched groups; these were further sub-categorized into major, minor and bidirectional. direct coombs test (dct) was performed when hemolysis was suspected in the post-transplantation period along with serum lactate dehydrogenase (ldh) %) were male and ( . %) female. mean age of abo matched and mismatched groups were ( . ae . ) years. most common indications for transplant included beta thalassemia major ( . %), aplastic anemia in ( . ) and pure red cell aplasia ( . %). source of stem cell was bone marrow in and peripheral blood patients abo matched while abo mismatched group comprised of ( . %) patients with further subdivision into major (n = ), minor (n = ) and bidirectional in the post transplantation period, packed red blood cell and platelets were transfused in matched group (n = ) and (n = ) comparably(n = ) and (n = ) in mismatched group. primary and secondary graft failure in matched group was . % and . % patients while in mismatched group graft failure was observed in ( . %) patients respectively. positive dct in abo matched group in ( . %) patient, whereas ( . %) patients with major and minor abo mismatch group with raised ldh levels and deranged lfts were found. episodes of acute and chronic gvhd in abo compatible and incompatible groups were insignificant. overall survival in abo summary/conclusions: these results indicate that abo incompatibility does not seem to influence outcome of the patients undergoing allogeneic hematopoietic stem cell transplantation. careful monitoring of patients can help detect problems early and treat them efficiently, thus, reducing the number of life threatening events a picascia , c sabia , f cavalca , g nicoletti and c napoli in our routine work with one lambda sab class ii reagents, we observed non-specific reactivity with some beads bearing dr and dr in patients without sensitizing events. this pattern was not confirmed by testing same sera with screening-and pra-beads suggesting non-specific reactions. aims: here, we sought to determine if fetal bovine serum (fbs) treatment would be effective in reducing/eliminating non-specific reactivity. methods: we tested sera pre-treated with fbs from non-sensitized patients that showed the dr /dr pattern. in particular, ll of fbs was added to ll of patient serum; incubated for min at °c; centrifuged and subsequently tested in the sab assay. as controls, we treated sera from patients with documented dsa including dr /dr and patients without hla antibodies. results: dr /dr non-specific reactivity was eliminated or significantly reduced after fbs treatment. we found that patients with dr and dr dsa had no change in mfi values and additional reactivity was not observed in negative fbs treated sera transfusion medicine, national blood transfusion centre transfusion medicine, national blood transfusion center transfusion medicine, national blood transfusion centre, tirana, albania background: abo blood group, has been associated with many diseases, although the explanation for abo's blood group association and some illnesses is still unclear. aims: to find the distribution of cases by blood groups in patients with malignant pathology compared to donors in order to assess the presence of the abo blood group as an epidemiological indicator to identify populations exposed to different malignant pathologies methods: we conducted a case-control study. abo blood group and diagnosis of all patients have been studied. the control sample was collected from , healthy donors from which group a ( , %), group o ( , %), b ( , %) and group ab ( , %) resulted. the study was conducted in patients who have been transfused and submitted a request to determine the blood group at the blood bank at qsut during the period - results: among the patients, when all malignant pathologies were taken together, the highest frequency was seen in blood group a ( . %), followed by ( . %), b ( . %) and ab ( . %). group a frequency was higher and o was lower compared to controls. a high incidence of blood group a is seen in: pancreatic cancer a ( %), in gastric cancer a ( %), colorectal cancer a ( , %), breast cancer a ( %), cervical cancer a ( %) and ovarian cancer a ( %) versus a ( . %) in the control group. a high incidence of blood b is seen in multiple myeloma b ( %) and cervical cancer b ( %) versus b ( . %) in the control group. blood group ab has a high incidence in malignant lymphoma ab ( %) versus ( . %) in the control group summary/conclusions: it appears that individuals with blood groups a, b and ab are more at risk of developing malignant pathologies and individuals with blood group o are more protected. background: the high homology and opposite orientation of rh genes promote many rearrangements between them and generate a large number of rhd and rhce variants which can be inherited together. several studies have shown that those rh variants in patients with scd represent an additional risk for alloimmunization and delayed hemolytic transfusion reactions (dhtrs), but little clinical or biological evidence related to alloimmunization and dhtr are presented for all the rh variant alleles. it is well established that transfusion recipients with the most common weak d types , and , are not at risk for forming alloanti-d when exposed to conventional rhd-positive rbcs. aims: we report here a case of a -year-old patient typed as weak d type , receiving d+ rbc units who presented anti-d in his plasma detected three weeks after the last transfusion. methods: rhd beadchip (immucor, nj, usa), was performed to identify the rhd variant allele associated with the weak expression of d. rhce genotyping was performed by laboratory developed tests. sequencing of rhd, rhce and rhag were performed to determine if there were other mutations that could explain the production of alloanti-d. serologic testing was by standard hemagglutination methods. the clinical significance of the antibody was evaluated by monocyte monolayer assay (mma). results: serological analysis showed a negative dat and the presence of anti-d in plasma ( + by gel). anti-lw was ruled out. rhd genotyping revealed the patient was rhd*weak d type . rhce genotyping predicted the d+c+c+e-e+ phenotype. sequencing of rhd, rhce and rhag found no additional changes and confirmed the presence of rhd*weak d type . mma showed the anti-d was clinically significant (> %). summary/conclusions: we report the production of alloanti-d in a scd patient with rhd*weak d type allele. weak d type patients are not considered to be at risk for allo anti-d but our results show that there are exceptions and that these anti-d can be associated with clinically significant rbc destruction. background: the mns blood group system is located on glycophorin a (gpa), glycophorin b (gpb) and hybrid glycophorins on the surface of the red blood cell (rbc). these glycoproteins are involved in complex structures interacting with other rbc surface proteins including the band /diego protein. the glycophorins are heavily glycosylated and contains multiple clinically significant blood group antigens. it has proved difficult to model the gpa extracellular structure due to its heavy glycosylation, and lack of homology with existing modelled proteins. aims: to develop an in silico model of gpa as a basis for improved predictions of structure function relationships methods: prediction of secondary structure and disorder: . . predictprotein (https://predictprotein.org); . . spider (http://sparks-lab.org/server/spider /); . . dsc (discrimination of protein secondary structure class): using an in-house implementation; . . jpred (http://www.compbio.dundee.ac.uk/jpred /); . . raptorx (http://raptorx.uchicago.edu). prediction of secondary structure: . . robetta (http://robetta.bakerlab.org/submit. jsp); . . falcon (http://protein.ict.ac.cn/treethreader/); . . itasser (https://zha nglab.ccmb.med.umich.edu/i-tasser/) threading methods to evaluate the quality of protein structures: . . verify d (http://servicesn.mbi.ucla.edu/verify d/); . . prosa (https://prosa.services.came.sb g.ac.at/prosa.php) protein-protein docking: . . gramm-x protein-protein docking web server (http://vakser.compbio.ku.edu/resources/gramm/grammx/); . . gramm (http://va kser.compbio.ku.edu/main/resources_gramm . .php) results: using in silico modelling we derived a stable tertiary glycosylated structure for gpa both as an individual protein and a homodimer. the hybrid glycophorin background: non-invasive prenatal testing of fetal antigen using cell-free fetal (cff) dna from maternal plasma of immunized women is widely implemented into clinical routine but the sensitivity and specificity of the method, especially for genotyping antigens encoded by single nucleotide polymorphisms such as k antigen, is limited by low proportion of cffdna in maternal plasma dna. according to literature reports detection of circulating tumour (ct)dna can be improved by selection of short ctdna fragments using automated electrophoresis methods. aims: the aim was to assess the feasibility for enrichment of cffdna fraction in maternal plasma dna by size selection using the pippin prep gel selection system. methods: plasma dna isolated using easymag (biomerieux) from rhd negative and k-negative pregnant women (n = ) carrying fetuses with known genotype was loaded into % agarose gel casette ( % df marker q , sage bioscience) and size selection of fraction was performed on a blue pippin tm (sage bioscience) with the elution from min to h min of electrophoresis. results for real-time pcr detection of fetal rhd, kel* and ccr (as a marker of total plasma dna) in dna fraction after gel selection were compared to results obtained from non-processed plasma dna. results: the total dna level (measured by ccr ) was significantly lower in dna samples tested after gel selection (from . to . geq/pcr) versus the level obtained from non-processed plasma dna (from to geq/pcr). the results for fetal fraction (measured by rhd) from dna samples of rhd-negative pregnant women carrying rhd positive fetus tested after gel selection were from , to . geq/pcr versus . - . geq/pcr for non-processed plasma dna. results for kel* detection in plasma dna from k-negative pregnant women carrying k-negative fetus were kel* -negative in dna samples tested after gel selection comparing to nonprocessed dna samples were false kel* positive amplification was observed. however, kel* detection in plasma dna from two k-negative pregnant women carrying k-positive fetus gave false kel* -negative results in dna samples tested after gel selection comparing to non-processed dna samples were kel* positive genotype was obtained. the total dna level in samples from k-negative women was from . to . geq ccr /pcr after gel selection versus from to geq ccr / pcr in non-processed dna samples. summary/conclusions: using the pippin prep gel selection system increases the proportion of cffdna fraction in total plasma dna by retaining long maternal dna fragments in the gel cassettes, but the protocol of gel separation dilutes the separated material decreasing the concentration of fetal dna and leading to false negative results of nipt. anti-rh quantification assay using ih- (bio-rad â ): promising results for monitoring rh:- pregnant women j beaud, h delaby, c toly-ndour, a mailloux and s huguet-jacquot centre national de r ef erence en h emobiologie p erinatale (cnrhp), hôpital saint-antoine, paris, francebackground: the generalization of immunoprophylaxis by anti-rh immunoglobulins since complicates the interpretation of the anti-red blood cell antibodies screening during pregnancy. to distinguish an alloantibody from a passive one, many laboratories in france use anti-rh microtitration. it is a column agglutination technology using red blood cells rh: , - , - , , (r r) . it permits to quantify low levels of anti-rh in comparison to a range of an anti-rh standard. performed since at the cnrhp and automated on evo clinical base tecan in (dilutions and distribution), anti-rh microtitration is well adapted to rh prophylaxis. aims: the aim of this study was to evaluate this technique on the ih- system from bio-rad â . methods: on ih- , the reactivity of the bio-rad â reagents was compared with the cnrhp reagents (red blood cells r r, anti-rh standard). the performances of the method were evaluated using three internal quality control (icq) ( cnrhp home-made at and ng/ml and bio-rad â at ng/ml) on papainized r r (plc) and native r r (nlc). a comparison of results from patient sera ranging from . to ng/ml was done between ih- and evo clinical base tecan. results: the results of the qci are similar between the different reagents used. there is no significant difference between the types of red blood cells except for the limit of detection: . ng/ml in plc - ng/ml in nlc. for the qci, the intra and interassay imprecision based on the dilution degree show coefficients of variation between and %, similar to those found with the evo clinical base. the correlation with the cnrhp technique performed on samples in plc and samples in nlc was satisfactory (deming plc: r = . y = . x + . -nlc: r = . y = . x- . ). summary/conclusions: the anti-rh microtitration on the ih- offers similar performances to the method conducted at the cnrhp. the ih- allows automated reading of gel cards. however, it does not have a calculation or interpretation algorithm and does not directly give the concentration of anti-rh . this final part remains manual and requires trained staff. background: haemolytic disease of the foetus and newborn (hdfn) due to maternal-foetal incompatibility has been perfectly framed for decades from the etiologic, pathogenetic and therapeutic point of view. the anti-d alloantibody is most frequently responsible for the most serious form of hdfn due to rhd incompatibility (rhdi hdfn). although immunoprophylaxis (ip) has reduced the number of cases of rhdi hdfn, this disease continues to occur and red blood cell alloimmunization still remains the most common cause of foetal anaemia. hdfn due to abo incompatibility (ab i hdfn) is currently the most common neonatal haemolytic disease in the western world. however, only in about . - % of cases haemolytic disease demands transfusion support. aims: analysis hdfn from to . methods: the hdfn's transfusional support is: intrauterine transfusion (iut) in the antenatal period; exchange transfusion (et) for severe hyperbilirubinaemia and neonatal transfusion of small volumes red cells for the newborn's late anaemia in the postnatal period. our policy for iut, for et and for the neonatal transfusion requires the use of a concentrated blood cells (ec) preferably group rh negative (cde/cde) or negative for any red cell antigens if the mother has antibodies, fresh (< days), preferably cmv safe. for iut, the ec must be compatible with mother's plasma, must have hematocrit + %, and irradiated. the unit for et must be compatible with the newborn's plasma, whit hematocrit % - % and irradiated. the ec used in post-natal transfusions is usually divided into rates of ml, hematocrit ae %. results: in last years, we calculated neonates with hdfn ( males and females): with rhdi hdfn, with ab i hdfn and with hdfn due to incompatibility for other red blood cell antigens. we have produced iut: for our hospitalized patients and for patients located in other hospitals. of these patients, who received iut, were immunized: showed anti-d antibody and antibodies different from anti-a and anti-b. , of the infants with rhdi hdfn, were transfused in utero. neonates on ( . %) have performed et: with ab i hdfn and with rhdi hdfn; the latter had also been transfused in utero. neonates on were transfused after birth: with rhdi hdfn, with ab i hdfn and with hdfn due to incompatibility for other antigens. summary/conclusions: our case studies reflect the literature data. neonates with rhdi hdfn are the most numerous ( . % of the total) and are those who have requested the highest blood supply both in the antenatal period ( . %) that postnatal ( . % performs et, . % performs postnatal transfusions). neonates with aboi hdfn are . %: nobody has received iut, only one has been subjected to et, and % has transfused after birth. patients with hdfn due to other antigens are %, have undergone iut . % and were transfused after birth . %. background: according to british guidelines on neonatal transfusion, since we shared with neonatologists a transfusion protocol for preterm babies. patients are anemic premature newborns with a gestational age ≤ weeks and/or a birthweight lower than g, until months of age. aims: reduce the incidence of iatrogenic anemia. methods: pre-transfusion tests were based on ab direct test, rh phenotype, direct and indirect antiglobulin test (dat, iat). a second blood sample was required for ab /rh confirmation. blood transfusions were performed with negative kell negative ( cde/cde/kk) cmv negative irradiated erythrocyte concentrates (ec) of less than days. ec were subdivided in ml aliquots with a hematocrit of ae %. according to the definition of "small volume transfusions", our protocol established that further four transfusions had to be delivered free of testing. after the fifth ec transfusion the supplementary release of ec was provided of type and screen (t&s) test with h of validity. serological investigation and full compatibility testing were applied in the presence of a iat and/or dat positivity and in the case of mother alloimmunization. results: from october to the end of , premature newborns received ec transfusions within their first months of life. in % of cases (n = ), transfusion requirement was comprised within the 'small volume transfusions'. another % of cases (n = ), requiring further ec administration, was requested of a blood sample for t&s determination and % (n = ) for a cross-match test. in . % of newborns (n = ), being transfused within the " small volume transfusions", blood requirement of ec was fulfilled by the initial blood test ( blood samples). . % of newborns (n = ) received more than transfusions ( - ; median = ) accounting for ec released and for this group blood samples were required. summary/conclusions: with the exception of babies requiring crossmatch test, blood tests were performed to sustain infants transfused with units. the alternative option of omitting crossmatch test (otherwise suggested by italian directives), allowed a reduction of % of blood drawn without any adverse effect or incident reported. due to the relevance of anemia in premature babies, we suggest the application of this transfusion policy in all newborns in the first months of life. background: glucose- -phosphate dehydrogenase deficiency (g pdd) is a sexlinked enzymopathy which is usually asymptomatic unless individuals are exposed to oxidative stress agents. the g pd genotype is the most common g pd genotype in sub saharan africa (ssa). some studies have linked blood from g pdd donors to poor outcome of a transfusion. however, there are no genetic screening programmes for blood donors in the region hence the contribution of g pdd to the donor pool in the ssa setting had not been described.aims: this study aimed to describe the prevalence of g pdd genotype among donors in two regions in uganda. it also described the effect of g pdd and the coinheritance of haemoglobin s and a-thalassaemia on the haematological quality of blood. methods: , blood samples from donor packs were utilized in a transfusion trial conducted in uganda, were genotyped for g pd , haemoglobin s and a-thalassaemia. haemoglobin and haematocrit measurements for the donor units (packs) at the time of transfusion were used to describe the effect of g pd and co-inheritance with a-thalassaemia (n = , ) and haemoglobin s (n = , ) on the haematological quality of blood packs. a subset of donor blood packs was utilized to determine the sensitivity and specificity of the carestarttm rapid diagnostic kit (rdt) for g pdd. results: based on g pd genotyping, . % (n = ) of the blood samples used in the trial were deficient for g pd enzyme while . % (n = ) were heterozygous. significant lower hemoglobin values were observed in red cell concentrates (p = . ) and whole blood (p = . ) donations of heterozygous g pd genotype. co-inheritance of g pdd and a-thalassaemia resulted in significantly lower haemoglobin levels. the carestarttm rdt test was . % sensitive and . % specific for detecting donor blood packs with g pdd. summary/conclusions: the prevalence of g pdd among ugandan blood donors was similar to that in the general population. the heterozygous genotype resulted in lower haemoglobin concentration of the blood units. the use of carestarttm rdt for screening of stored blood units was not as efficient in this study hence further testing for the determination of g pdd needs to be done on fresh samples from donors. transfusion medicine, jaypee hospital, noida, india background: during last two decade there has been a continuous remarkable improvement in desensitization therapy in high risk hla sensitized kidney recipients. in india there has been a tremendous increase in the number of kidney transplantations in patients having anti-hla antibodies (hla sensitized) with excellent success rate. aims: in present study, we are describing successful role of desensitization in hla sensitized patients having preformed donor-specific hla antibody (dsa). methods: all patients were preconditioned with combined modality of a standard dose of rituximab, therapeutic plasma exchange (tpe) and low dose ivig. tpe was started using com. tec (fresenius kabi, germany) after days of administration of rituximab. complement dependent cytotoxicity cross match (cdc-xm), luminex cross match with donor lysates (lm-xm, immucor inc., ga, usa) and flow cytometry cross match (fc-xm, bd facs canto ii).) was done in all cases. if any of the three tests was positive, single antigen bead assay (sab) was performed. desensitization therapy was given in all cases where dsa was detected. pretransplant tpe procedures were done until dsa (mfi < ) and cdc-xm became negative. cdcxm labeled positive at ≥ %. t-cell fcmx was considered positive above mfi and b-cell fcmx was considered positive above mfi. lmxm was considered positive above mfi. sab was performed using lifecodes single antigen (lsa) class i and class ii kits (immucor, usa). if the specificity of anti-hla antibodies was against donor hla antigen(s) it was called as donor specific antibody (dsa). results: present study demonstrated the diagnostic and clinical superiority of adding fc-xm and lm-xm in pretransplant compatibility testing algorithm over cdc-xm. cdc-xm alone was not able to detect anti-hla antibody in patients ( . %). among the three pretransplant compatibility tests, fcxm demonstrated highest sensitivity. among the cases initially screened showed dsa positivity in sab. desensitization was done in those cases only. in our study, sab was positive for class ii alone in ( %) while in remaining ( %) cases it was positive for both class and class ii. the number of pre transplant tpe procedures required was . ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) . the mean number of post-transplant tpe sessions required was . (range, - ). during pretransplant and post transplant tpe procedures, five ( . %) patients presented with allergic or hypotensive reactions which were managed conservatively. most of the patients were discharged after seven days of hospital stay whereas patients who required post-transplant tpe were discharged after a relatively longer hospital stay (mean- . , median- days). after three months, protocol biopsy was done in those cases only where post transplant tpe was required. protocol biopsy showed normal findings. in present study, the mean duration of follow up was approx months with the longest duration of follow up of months. summary/conclusions: in a country like india where there is a huge gap in the demand and supply of kidney and a large no. of patients waiting for a suitable organ, transplant across hla barrier could a good doable option. thorough pretransplant compatibility and tpe are essential tools to make these transplants program successful background: most transfusion-dependent chronically anemic patients are managed by simple red cell transfusions. however, some patients are not able to tolerate the additional volume associated with simple transfusions and are at a high risk of developing transfusion associated circulatory overload, if transfused with multiple red cell units. plasma-to red cell exchange (prx) is a modified procedure wherein an apheresis machine is used to remove patient's plasma, while simultaneously replacing with donor rbcs. this procedure allows for a rapid euvolemic transfusion of rbcs to patients that are severely anemic and intolerant to excess fluid volume. others as well as our group have previously described this procedure. we now summarize our institutions nearly seven years of experience performing this procedure on a routine basis. aims: to document patient experience with prx. methods: we performed a retrospective chart review of all patients that underwent prx at our institution in the last seven years. our protocol for prx has evolved during this period. currently, we perform the procedures using spectra optia (terumo bct, lakewood, co) machine using the plasma-exchange program and tubing set. if the patient's pre-procedure hematocrit (hct) is < %, we custom prime the tubing set with % albumin. the number of red cell units transfused to the patient depends on their pre-procedure hematocrit and is individualized to the patients. results: we have treated four patients with prx procedure. patient # is a -year-old transfusion-dependent male with beta-thalassemia major. the patient had experienced multiple congestive heart failure exacerbations secondary to simple transfusions and we consequently performed prx procedure, every weeks, starting in . the patient has completed procedures with - units of washed red cells transfused to achieve a target hct goal of to %. he tolerated all procedures without any volume overload issues. he continues on this transfusion regimen. patient # was a -year-old female who had symptomatic anemia secondary to sickle cell disease (hb ss complicated by end-stage renal disease (esrd). she had progressively become intolerant to simple transfusions, including an episode of severe dyspnea, which required intubation. she underwent prx procedures with - units of washed red cells. patient tolerated the procedures without any significant complications. however, during a different surgical procedure, she experienced cardiac arrest and subsequently passed away. patient # is a -year-old transfusion-dependent male with severe anemia secondary to sickle cell anemia (hb ss). he was intolerant to excess fluid because of esrd and congestive heart failure. he has undergone prx procedures with - red cell units transfused to achieve a hct goal of %. he tolerated all procedures without any volume overload issues. he continues on this transfusion regimen. patient # is a -year-old male with a sickle cell disorder (hb ss) complicated by esrd, heart failure and chronic hypoxemic respiratory failure. the patient has undergone two prx procedures with - red cell units. other than an episode of non-bloody emesis that was symptomatically treated, he tolerated both procedures. he continues to be managed on this regimen. however, the patient remains noncompliant with treatment. summary/conclusions: prx is a safe and efficient method to transfuse multiple red cell units to volume-intolerant anemic patients. background: transplanted organ failure due to antibody mediated rejection in abo-compatible organs is a serious complication with a bad prognosis. the goal treatment in these cases encompasses the following strategies: adjustment of the immunosuppressive medications, ivig infusion, antibody removal by therapeutic plasma exchange, and/or the use of target-specific monoclonal antibody medications to lymphocytes, plasma cells, and/or complement. the american society for apheresis has assigned a category i to the use of therapeutic plasma exchange for the treatment of abo-compatible antibody mediated rejection in kidney, but a category iii to all other abo compatible organs: liver, lung, and heart. at our institution, a standardized approach for the use of therapeutic plasma exchange as a supportive intervention for abo-compatible immune mediated rejection, regardless of the organ type, has been in place since . aims: a retrospective review was performed to evaluate our patient outcomes using therapeutic plasma exchange for the treatment of antibody mediated allograft rejection in abo-compatible solid organ transplantation. methods: patients used for the retrospective review were selected from an existing therapeutic apheresis list. the therapeutic plasma exchange protocol consists of: adjustment of the immunosuppressive medications, ivig infusion, antibody removal by therapeutic plasma exchange, and/or the use of target-specific monoclonal antibody medications to lymphocytes, plasma cells, and/or complement. it is performed as follows: one plasma volume exchange is performed on days , , , , , along with one or more of the above strategies followed by an ivig infusion. cases with allograft rejection in which plasmapheresis was not used were excluded. and t devos aims: this study aimed to explore the possible causes of the decreased transfusion rate for all adult cardiac surgery patients. methods: data were collected from adult cardiac surgery patients during the mentioned time frame and were extracted from electronic patient files and a database of the department of cardiac surgery. a set of variables was defined as possible confounders by a panel of experts. after discussion, global variables (age, gender, duration of surgery, use of cpb (cardio-pulmonary bypass), american society of anesthesiologists (asa) risk score, type of surgery, urgency, attending cardiac surgeon and attending anesthesiologist) and cpb-related variables (administration of cardioplegia yes/no (cpg), duration of cpb, circulatory arrest, hypothermia, duration of aortic cross-clamp, baseline hemoglobin and cpb-priming volume) were retained. negative binomial models for counts were used for data analysis. all analyses were performed with spss. results: patients were extracted from databases and further analyzed. the mean age of this group was , years (sd +/- , years) and . % of them were male. the mean duration of surgery was min (sd +/- , min). the decrease of perioperative rbc transfusion rate over four years was statistically significant (p < . ). in , the mean use was , units per operation (sd +/- , ), which changed to , units (sd +/- , ) in . three variables (urgency, attending cardiac surgeon, attending anesthesiologist) changed significantly over years and were used in a multivariable model as confounders together with rbc transfusions and year. even after adjustment for these factors, the decrease in rbc transfusion rate was still statistically significant (p < . ). in the specific group of patients undergoing cardiac surgery with cpb (n = ), the use of rbc was also significantly reduced (p < . ). in , the mean use was , units per operation (sd +/- , ) and this changed to , units (sd +/- , ) in . after correction for the cpb variables that notably changed over the years (cpg, priming volume and hypothermia) and the three previously defined confounders (urgency, attending cardiac surgeon and attending anesthesiologist) the reduction of rbc transfusions over years still remained statistically significant (p < . ). summary/conclusions: our study shows evidence for a decreased rbc transfusion rate in adult patients undergoing cardiac surgery between and . this tendency was also seen in the subgroup of patients undergoing surgery with cpb. possible explanations of the decrease are implementation of various established parts of patient blood management. however, a unique reason could not be identified in this study. background: growing worldwide demand for immunoglobulin products such as intravenous immunoglobulin (ivig) and subcutaneous immunoglobulin (scig) is driving plasma collection. patients with primary immunodeficiency (pid) or secondary immunodeficiency due to haematological malignancy or its treatment (sid) rely on these products to maintain therapeutic serum igg levels to minimise recurrent infection. efficacy of immunoglobulin replacement therapy (irt) in pid is well established but information on sid is limited. the different aetiologies of hypogammaglobulinaemia between pid and sid raised the question of whether sid patients on irt experience similar clinical and quality of life (qol) benefits as reported in pid patients. aims: to assess whether sid patients experience similar clinical and qol benefits while on irt as pid patients. methods: following ethics approval, data on dosage, serum igg trough levels and infection (bacterial, viral and fungal requiring treatment such as antibiotics) was collected from adult pid and adult sid patients from medical records and pathology reports, for their last months of ivig and their first months of scig. the starting and maintenance dose was . g/kg/month for ivig, transitioning immediately to . g/kg/week for scig without a washout period. a study specific questionnaire was developed to gather data on patient perceived side effects, treatment satisfaction and impact of irt on social/family life, work/study and their overall qol. paired t-test was used for parametric data and the wilcoxon signed-rank test for non-parametric data. results: sid patients were significantly older with a mean age of . years versus . years in pid patients (p = . ). a mean of three training session was required to reach competency in scig administration in both cohorts. there was a trend of reduced side effects on scig for pid and sid patients compared to ivig, with a significant reduction of headaches in the pid cohort (p = . ). the majority of patients experienced infusion site reactions, which were predominantly perceived as manageable. % of infections were respiratory tract infections. pid patients had slightly higher mean serum igg trough levels with scig ( . g/l) compared to ivig ( . g/l), and fewer infections on scig than ivig (mean annual infection rate of . vs . respectively). sid patients had higher mean serum igg trough levels on scig ( . g/l) than ivig ( . g/l) (p = . ) but experienced more infections while on scig versus ivig (mean annual infection rate of . vs . respectively). the number of hospitalisation due to infection decreased in both cohorts with scig. pid patients perceived that switching from ivig to scig improved their health and qol. in contrast sid patients perceived no improvements in health and qol. summary/conclusions: data from this pilot study suggests that the clinical and qol impact of irt in sid patients is different to that of pid patients. to support evidence based irt management and effective use of this limited and expensive blood product in sid, larger studies which account for different stages of malignancy and associated treatment regimes are required. background: there is an increasing platelet transfusion for treatment and prophylaxis of bleeding in patients with hematologic disorders and malignancies. because of limited resources, leukoreduced platelet concentrates is not yet implemented in most indonesian hospitals. in vitro platelet activation may cause morphology, functional, and ultrastructure changes. those changes will reduce the platelet viability, in vivo functions, and clinical efficacy. high platelet cd p expression is the cause of faster platelet destruction in the reticuloendothelial systems. post-transfusion in vivo hemostatic efficacy can be determined by the measurement of corrected count increment (cci), recovery, and platelet cd p expression. aims: to analyze the increase of platelet cd p expression in patients of non-leukodepleted compared to pre-storage leukodepleted pc transfusion.background: haemorrhage is a leading cause of preventable death not only in the military trauma care, but also for civilian population suffering accidents or bleeding injuries in regions with low population density where health services should reach people in remote areas. resuscitation using blood products and limited infusion of normal saline improves survival for critically bleeding patients. nowadays there are hems programs (helicopter emergency medical system) carrying blood products around the world. the hems in castilla-la mancha, with physician and nurse, is the first out-of-hospital emergency service in spain that provides packed red blood cells (prbc) transfusion where the accidents happen without delaying the transport to the proper hospital for definitive treatment. this program has been developed between the blood center of ciudad real and the hems team ('gigante ', emergency service castilla-la mancha). the goal of the designed protocol was to preserve the properties of the product to be transfused in out-of-hospital environment by hems teams. aims: to describe the process for out-of-hospital prbc transfusion in hems of ciudad-real. the protocol for out-of-hospital blood transfusion was developed according to criteria of medical indications and security, monitoring, and tracking of the product. methods: data for the observational retrospective study were collected from june to august . the medical helicopter (ec t ) was provided with two prbc o rh(d) negative. the shock index was selected for the indication for transfusion according to the literature revised and as a simple rate to obtain out-of-hospital data. to achieve the feasibility and preservation of the prbc a prospective monitoring of volume was established, haematocrit, haemoglobin, leucocytes, coulter, hemolysis and microbiological culture. blood center established two groups: the case group for the prbc kept in the hems base and helicopter and the control group for the units remaining in the blood center with standardized blood conservation. for both groups, control and comparison of immediately obtained hematologic analyses, and days after collection, were performed. the statistical analysis used spss . version (significance p < , ). results: prbc samples were evaluated, , % ( ) from case group and , % ( ) from control group. analyses were tested day and day after collection. haemolysis was not observed. all cultures were negative. although significant differences were found between the parameter in the value of before-after in the value of the hematocrit, leukocytes and coulter, there are no differences between the prbc that flew and those conserved in the transfusion-service. all results comply with current legislation and blood transfusion standards. there have been administered prbc transfusion to patients during out-of-hospital advanced medical assistance. no post-transfusion reactions have been registered. prbc units have a -day rotation to allow the use of the units in the hospital after achieving their optimal status. summary/conclusions: the out-of-hospital transfusion protocol designed to transport blood (prbc) in the helicopter for hems has demonstrated to keep the standard conditions and properties of the product to be considered useful in the treatment for critically bleeding patients in the out-of-hospital. background: early and adequate treatment of major bleeding is important for survival and a good outcome. blood and plasma are given increasingly early including before hospital admission in trauma based on successes reported from combat experience. in the national patient safety agency issued a rapid response report requiring national health service hospitals in england to take actions to improve provision of blood in an emergency including provision of major haemorrhage protocols (mhp) and drills. the national reporting and learning scheme had identified reports of deaths and instances of harm due to delay over a -year period. aims: the aim of the study was to monitor the acid-base status of the patient by means of abg and to administer the blood component therapy based on teg results. methods: this study was a prospective observational study of adult patients over a period of months. serial monitoring of the abg in the intra-operative period was done. teg guided resuscitation was performed in all cases. results: the abg analysis of all patients showed decrease in the ph, increase in pco , decrease in serum bicarbonate level and elevation in negative base excess. these components of metabolic acidosis can be attributed to massive transfusion. increased lactate, an independent parameter, which reflects poor tissue perfusion or shock and predicts need for massive transfusion was observed in all patients. all the cases showed a decrease in ionized calcium levels which could be a result of citrate related toxicity. increased glucose was observed in all patients which may be due to increase in the catecholamine release as a response to haemorrhagic shock. electrolyte correction was given depending on results of the abg analysis wherever appropriate. two out of cases showed an increase in r time indicating deficient coagulation factors, which was corrected with fresh frozen plasma (ffp). three cases showed elevation in k time indicating deficient fibrinogen levels, which was corrected by ffp. fresh frozen plasma was also given in cases, which showed decrease in the alpha angle, indicating deficient fibrinogen, and cryoprecipitate was given in cases. platelets were transfused in patients showing a decrease in the maximum amplitude (ma), which indicates deficient platelets. summary/conclusions: teg as poc testing is an important tool in appropriate blood component therapy in massive transfusions. serial monitoring of abg helps in monitoring acid-base status of the patient and therefore is a guide in the correcting electrolyte level in patients undergoing massive transfusion. background: massive blood loss is encountered in various situations like trauma, major surgeries, gastrointestinal bleeds and obstetric haemorrhages. haemorrhage is an important cause of mortality and morbidity in massively bleeding patients. early recognition of haemorrhage and intervention is essential for survival. massive transfusion (mt) of blood is required to replenish blood losses and is a lifesaving treatment in these patients. a variety of haemostasis and pathophysiological changes occur during massive haemorrhage and massive transfusion. all of these changes contribute to the vicious cycle of progressive coagulopathy due to the 'lethal triad' of refractory coagulopathy, progressive hypothermia and persistent metabolic acidosis. aims: the aims of the study included understanding management of cases of massive blood transfusion in surgical patients, impact of mt of blood components on patient outcome, evaluating post-operative complications of massive transfusion and the development of institutional massive transfusion protocol (mtp).methods: this prospective observational study commenced after institutional ethics committee (iec) approval. it comprised of adult surgical oncology patients who received massive transfusions and was conducted for a period of months. every case of a massive transfusion was studied under the following headings ( ) patient's details ( ) patients base-line laboratory tests ( ) resuscitation with transfusion ( ) intra-operative laboratory tests ( ) thromboelastography (teg) ( ) post-operative complications ( ) duration of stay in the hospital ( ) day mortality rate. results: complete blood count, serum electrolytes, arterial blood gases, coagulation profile and teg were used to monitor transfusion therapy in the intraoperative period. intraoperative laboratory parameters of patients showed dilutional coagulopathy, metabolic acidosis, hypocalcaemia, hypomagnesaemia, hyperkalaemia and hypokalaemia, increased lactates and glucose. electrolyte correction was done based on the derangement. the derangements were on a decreasing trend in the postoperative period and returned to baseline level by nd or rd post-operative day with no requirement of correction in the post-operative period. the post-operative outcomes were evaluated in terms of the surgical site infection (ssi) as per the centers for disease control (cdc) criteria, surgical complications as per modified clavien-dindo classification and respiratory complications. a total of ( . %) patients had ssi, ( %) had surgical complications and ( %) patients had respiratory complications. the length of the stay in the hospital was longer for patients who had postoperative complications. despite complications, owing to excellent peri-operative care, ( %) patients were discharged alive. summary/conclusions: surgeries associated with massive transfusion are at an increased risk of ssi as well as morbidity and mortality. complications associated with rapid transfusions of blood, acute haemorrhage and associated risk of the surgery lead to a prolonged icu stay and increased length of stay in the hospital. a well-developed massive transfusion protocol optimizing the ratio and dose of the blood component therapy results in excellent patient outcome with minimal postoperative morbidity and mortality. background: despite the introduction of new oral anticoagulants (dabigatran, rivaroxaban, apixaban), vitamin k antagonists (vka), such as warfarin and acenocoumarol are still the most widely used oral anticoagulants for the treatment of non-valvular atrial fibrillation (nvaf). the use of vka must be regularly and often laboratory controlled in order to ensure the adequacy of therapy and to avoid subdosing or drug overdose. the most commonly used test for the control of oral anticoagulant therapy is the prothrombin time (pt), expressed in inr system, which provides an internationally standardized monitoring of the treatment. time in therapeutic range (ttr) represents a measure of the quality of the anticoagulant effect of vka and estimates a percentage of time a patient's inr is within the desired therapeutic. aims: the aim of this study was to evaluate of the effectiveness of vka therapy in patients with nvaf and to identify factors affecting the anticoagulation efficacy. methods: a retrospective study was conducted on a population of outpatients with nvaf, treated with vka and followed in blood transfusion institute of ni s from january to december . laboratory control of inr was done from capillary blood of patients on thrombotrack solo (axis shield, norway) and thrombostat (behnk elektronik, germany). targeted ae . %, but . % of patients had a ttr less than %. patients were at high risk of thrombosis in . % of time (inr < . ) and high risk of bleeding in . % of time (inr > . ). the most significant independent factors affecting the quality of vka therapy are gender, arterial hypertension, diabetes mellitus and the use of amiodarone and antiplatelet drugs (aspirin, clopidogrel). summary/conclusions: the ttr is undoubtedly useful indicator of the effectiveness of vka treatment. the most important predictors of poorer efficacy of vka therapy are arterial hypertension, diabetes mellitus, patients' gender and the use of amiodarone and antiplatelet (aspirin, clopidogrel) drugs. to improve the quality of vka therapy, education of patient and better collaboration with them, as well as a successful teamwork with clinicians are also imperative. background: an estimated . million deaths per year result from haemorrhagic blood loss. at a cellular level, haemorrhagic shock develops when oxygen delivery is insufficient to meet oxygen requirements to maintain aerobic metabolism. successful resuscitation prevents further oxygen debt and repays the prior oxygen debt. this includes the administration of fluids and blood components (e.g. plasma, red cells and platelets). measurement of oxygen delivery and utilisation at a tissue level requires invasive monitoring not possible clinically, meaning that surrogate markers such as lactate and venous oxygen saturation (svo ) are used instead. new technologies such as incident dark field imaging and near-infrared spectroscopy may offer a non-invasive alternative; however their utility in haemorrhagic shock remains background: transfusion-induced red cell alloimmunization is still a major challenge in transfusion practice. besides logistic problems for the transfusion laboratory, it may compromise available blood supply, and when undetected and unanticipated, it may risk haemolytic transfusion reactions. knowledge about risk factors can help to optimize preventive matching strategies. severe renal failure and subsequent renal replacement therapy influence the immune system and could therefore modulate the risk of alloantibody formation against foreign red cell antigens subsequent to transfusion. aims: this study aims to quantify the association between renal failure, according to its degree and its treatment with renal replacement modalities, and transfusioninduced red cell alloantibody formation. methods: we performed a multicenter case-control study within a source population of patients receiving their first and subsequent red cell transfusion between and in the netherlands (risk factors for alloimmunization after red cell transfusion, r-fact study). using a conditional multivariate logistic regression, we compared first-time transfusion-induced red cell alloantibody formers (n = ) with two similarly exposed non-alloimmunized control recipients (n = ) during a five-week alloimmunization risk period. degree of renal function was categorized as: 'no renal failure' i.e. glomerular filtration rate (gfr) > ml/min/ . m , 'moderate renal failure' i.e. gfr ≥ - ml/min/ . m during a continuous period of minimally seven days, 'severe renal failure' i.e. gfr < ml/min/ . m and/or use of any type of renal replacement therapy during at least one day of the alloimmunization risk period. odds ratios were interpreted and presented as relative risks (rr). adjusted rrs were conditioned on the matching variables and identified confounders. results: no renal failure was observed among ( . %) cases versus ( . %) controls; moderate renal failure among ( . %) cases versus ( . %) controls; and severe renal failure among ( . %) cases versus ( . %) controls. among the latter, cases and controls underwent renal replacement therapy. moderate renal failure and severe renal failure without renal replacement therapy were not significantly associated with red cell alloimmunization (adjusted rr . , % ci . - . and adjusted rr . , % ci . - . , respectively). however, patients undergoing renal replacement therapy had a two-fold lower alloimmunization risk (adjusted rr . , % ci . - . ) as compared to transfusion recipients without renal failure, unrelated to type and duration of renal replacement therapy. summary/conclusions: these findings suggest that patients undergoing renal replacement therapy have strongly diminished red cell alloimmunization risks. further research should confirm these results and elucidate the underlying pathophysiological protective mechanism. background: the ability of allogeneic hematopoietic stem cell transplantation(allo-hsct) to prevent relapse depends partly on donor natural killer (nk) cell alloreactivity. nk effector function depends on specific killer-cell immunoglobulin-like receptors (kir) and hla interactions. thus, it is important to identify optimal combinations of kir-hla genotypes in donors and recipients that could improve hematopoietic transplantation outcome. aims: to obtain the optimal combinations of inhibitory kir and its ligand between donor and recipient which is helpful for the guidance of selecting donors and recipients in hsct. methods: the pcr-sbt method was used for kir dl , kir dl /kir dl , kir dl , kir dl and hla-a, -b, -c, -drb , -dqb genotyping. pairs of hla / identical donor/recipients matching samples were retrospectively analyzed. three different models of kir were established. there were kir-kir gene model, kirligand model and haploid model. in kir-ligand model, patients were divided into three groups: c /c homozygote group ( cases), c /c heterozygote group ( cases) and c /c homozygote group ( cases). according to the expression of dl , cases were dl positive and cases were dl negative. there were cases of bw /bw , cases of bw /bw and cases of bw /bw in the dl positive samples. according to the expression of a /a , they were divided into three groups: a /a negative group ( cases), a /a heterozygous group ( cases) and a / a homozygote ( cases). according to kir genotyping, kir haploidentical group ( cases) and kir haploid mismatched group ( cases) were divided. the clinical data on neutrophil and platelet remodeling time, gvhd and os of cases were statistically analyzed by the mann-whitney test or the kruskal-wallis test using graph-pad software v . . results: there was no significant difference in the time of neutrophil and platelet remodeling, the incidence of agvhd and the survival time after transplantation in the kir genotype model. in haplotype model, there was no significant difference in neutrophil and platelet remodeling time and survival time after transplantation. the incidence of agvhd was low when the kir haploid mismatched and kir dl was positive. it was conducive to neutrophil and platelet remodeling when bw /bw and a /a was heterozygosity. summary/conclusions: it is important to establish the three different models of kir genotypes, haplotypes and receptor-ligand mismatches for analyzing the effect on the prognosis of allo-hsct. kir-ligand model plays an important role in hla unre-background: transfusion of platelet concentrates (pcs) has been associated with adverse outcomes including transfusion-related acute lung injury (trali). the underlying mechanism of trali has been related to the accumulation of immunomodulatory mediators (e.g. lipids, cytokines/chemokines) present in pcs. current room temperature storage limits the shelf-life of conventional pcs to - days. alternative storage conditions, including cryopreservation, offers extended storage and a solution for blood banking logistics. cryopreservation of human pcs has been associated with higher concentrations of immunomodulatory mediators compared to room temperature stored pcs and it has been suggested that cryopreserved pcs may be immunomodulatory. to investigate the effects of cryopreserved pcs, a transfusion sheep model would be a beneficial approach. aims: to characterize immunomodulatory mediators in supernatants of sheep conventional and cryopreserved pc and to investigate whether storage duration and cryopreservation impacts the accumulation of these mediators. methods: buffy coat pooled sheep pcs (n = ), prepared in % plasma/ % ssp+ with minor modifications to standard human procedures, were stored room temperature (rt) for days (d) and sampled on d , d and d . cryopreserved sheep pcs (n = ), prepared by the addition of - % dimethyl sulfoxide, were stored at À °c and sampled pre-freeze and post-thaw. supernatant was prepared at each time point with double centrifugation and stored at À °c. concentrations of pro-inflammatory cytokines (interleukin (il)- , il- b, il- a), anti-inflammatory cytokine il- and chemokines (il- , monokine induced by gamma interferon (mig) and interferongamma induced protein (ip)- ) were measured using sheep specific in-house and commercial enzyme linked immunoassays (elisa). levels of non-polar lipid mediators, such as arachidonic acid (aa), -hete and -hete were assessed in the stored sheep pc-and cryo-pc supernatant using commercial elisa. results shown as mean ae standard deviation. the effect of storage was determined at p < . using paired t-test. results: in rt stored sheep pc supernatant il- , il- b, il- a, il- , il- , mig, ip- , -hete and -hete were detected at d , d and d . storage duration significantly increased accumulation of ip- at d ( . ae . pg/ml compared to . ae . pg/ml, p = . ) and further increased at d , and il- at d ( ae . pg/ml compared to ae . pg/ml, p = . ). cryopreserved sheep pc supernatant pre-freeze and post-thaw contained equivalent or higher concentrations of il- , il- b, il- a, il- , il- , mig, ip- , -hete and -hete than rt stored d pcs. however, cryopreservation did not impact levels of any of the platelet derived mediators. summary/conclusions: several platelet-derived cytokines/chemokines, including high concentration of il- with neutrophil priming activity, and non-polar lipids were found in stored sheep pc supernatant. these immunomodulatory mediators may contribute to adverse outcomes associated with pc transfusion. storage at rt, but not cryopreservation was associated with increased accumulation of immunomodulatory mediators in sheep pcs. most importantly, similar to human pcs, sheep cryopreserved pcs contained at least if not higher concentrations of majority of cytokines as pcs stored at rt, therefore making sheep a suitable model in which to investigate immunomodulatory effects of cryopreserved pc transfusion. background: transfusion, despite being a lifesaving therapy, has been associated with adverse transfusion outcomes. transfusion related acute lung injury (trali) remains one of the leading causes of transfusion-related mortality. accumulation of immunomodulatory mediators (e.g. lipids, cytokines/chemokines) present in blood products, including packed red blood cells (prbcs), have been implicated with the development of non-antibody mediated trali. however, how specific mediators contribute to the underlying mechanism is yet to be defined. during routine storage of human prbcs fewer than cytokines/chemokines and several biologically active lipids have been identified. a sheep model of trali has successfully been developed using human prbc supernatant, however transfusing sheep prbc has not been investigated. to support the use of sheep prbc in the trali model and to better understand the precise mechanism, characterization of the potential mediators in sheep prbc is required. aims: to characterize immunomodulatory mediators in sheep prbc supernatants and to investigate whether storage duration impacts the accumulation of these mediators. methods: sheep prbcs (n = ), prepared according to standard human procedures with minor modifications, were stored ( - °c, days (d) ) and sampled at d and d . supernatant was prepared by double centrifugation and stored at À °c. concentrations of pro-inflammatory cytokines (interleukin (il)- , il- b, il- a), antiinflammatory cytokine il- and chemokines (il- , monokine induced by gamma interferon (mig) and interferon-gamma induced protein (ip)- ) were measured using sheep specific in-house and commercial enzyme linked immunoassays (elisa). levels of potential non-polar lipid mediators (arachidonic acid (aa), -hydroxyeicosatetraenoic acid (hete) and -hete) were assessed in the sheep prbc supernatant using commercial elisa. paired t-test was used to compare fresh and stored prbc supernatant (p < . ). results are mean ae standard deviation. results: at day , aa ( , ae , pg/ml), -hete ( . ae . pg/ml), -hete ( . ae . pg/ml) and il- b ( . ae . pg/ml) were detectable in sheep prbcs supernatant. at day , storage duration significantly increased concentrations of aa ( , ae , pg/ml, p = . ) and -hete ( . ae . pg/ml, p = . ) in sheep prbcs supernatant. summary/conclusions: similar to reported findings of human prbcs, the predominant type of immunomodulatory mediators present in sheep prbcs were non-polar lipids. the concentration of these non-polar lipids increased during storage. these immunomodulatory mediators may contribute greatly to adverse outcomes associated with prbc transfusions. further investigation is required to determine whether stored sheep prbcs supernatant induce immunomodulation in sheep in vitro and in vivo transfusion models. background: dshtr incidence is reported as in , transfusions, presenting days to months after the transfusion. the published data addressing the correlation between the strength of the antibodies detected after a dshtr has taken place and the corresponding clinical symptoms as measured by laboratory parameters that assess the presence of hemolysis is limited. aims: the aim of this study is to evaluate the correlation between the results of the dat, automated and manual antibody reactivity strength with the corresponding clinical parameters of hemoglobin, lactate dehydrogenase (ldh), bilirubin, and haptoglobin. methods: a dshtr is defined as discovering a new antibody within days of a transfusion. for all positive antibody screens, a work-up is initiated consisting of identification panels, dats, antigen typing of the red cells transfused, and eluates at the discretion of the transfusion medicine physician. additional laboratory testing for hemolysis is requested when indicated. a retrospective review was conducted of patients who were identified as having a dshtr. levels of hemoglobin, ldh, and transfusion safety background: rhd immunoglobulin (rhdig) has been available for years in australia. since its introduction for routine antenatal and postpartum prophylaxis, alloimmunisation has decreased from % to . %, reducing the number of australian deaths from haemolytic disease of the newborn over a hundred-fold, to approximately . deaths per . blood matters serious transfusion incident reporting (stir) system has been collecting transfusion incidents and adverse events across four australian jurisdictions since . since january , rhdig administration errors have been reported. aims: to understand incidents relating to the administration of rhdig and increase safety and awareness of risks. methods: health services registered with stir (n = ) were notified of the inclusion of reporting rhdig incidents. when an incident is identified, the reporter sends an online notification to stir, prompting the appropriate investigation form to be sent for completion. the completed incident data are reviewed and validated by an expert group. data is de-identified and collated for reporting. results: during the period january -december , reports were received; reports were validated, with reports excluded (reactions rather than administration errors). reports were categorised as below: background: following the nice transfusion guidelines, recommending offering iron before and after surgery to patients with iron-deficiency anaemia (ida), we worked collaboratively with the anaesthetic and pre-operative team to implement a clear and robust anaemia pathway for pre-operative haemoglobin (hb) optimisation. oral iron was started, where appropriate, and our anaemia pro-forma was sent for review in a virtual clinic to assess eligibility for intravenous iron. we performed a retrospective evaluation of the patients who received iv iron during the anaemia pathway. aims: the aim of this retrospective evaluation was to look at the cohort of patients who had received iv iron in and assess the effect of iv iron on haemoglobin levels for different defined groups. methods: we classified patients, as described in munting and klein, , depending on their iron parameters as having either: -idaserum ferritin < mg/l -chronic inflammation with idaserum ferritin - mg/l with transferrin % of < %/crp > mg/l -anaemia of chronic inflammationserum ferritin > with transferrin % of < %/crp > mg/l patients were considered eligible for iv iron if the following criteria were met: . an inadequate response to oral iron, or were unable to tolerate oral iron or the interval between diagnosis and surgery was short . the anaemia pro-forma was completed . hb was ≤ g/l . they were classified as either having ida or chronic inflammation with ida or anaemia of chronic inflammation hb was measured prior and on average, days following the iv iron infusion. we excluded patients who had their post iv iron follow up blood tests done after surgery. results: this retrospective evaluation included patients. patients were classified as having ida and patients classified as having chronic inflammation with ida. those classified with ida had a mean hb of g/l ( - ), a mean mcv of . fl and a mean serum ferritin of lg/l. those with chronic inflammation with ida had a mean hb of g/l ( - ), a mean mcv of . and a mean serum ferritin of lg/l. follow-up hb was measured on average twenty days post iv iron infusion in both groups. the average hb post iv iron infusion in the ida group was g/l ( - ) with an average increment of g/l and in the group with chronic inflammation with ida the average post iv iron hb was g/l ( - ) with an average increment of g/l. summary/conclusions: in conclusion the group with ida had, on average, a lower starting hb that the group with chronic inflammation with ida and the average increment in hb days post iv iron infusion was greater in the group with ida. however, the group with chronic inflammation with ida cases also responded to iv iron and therefore we strongly consider the use of iv iron in both groups. further studies to evaluate the ongoing effect of iv iron would help assess whether the same level of increment seen with ida can also been seen for the group with chronic inflammation with ida over a longer period and how long the increment was sustained. background: the expansion of personalized genomic medicine has led to the development of targeted therapeutic approaches for patients. one example is sipuleucel-t, an autologous cellular immunotherapy product used to treat prostate cancer manufactured from the patient's white blood cells. this study describes our experience with incorporating autologous cellular immunotherapy products into the workflow of the blood bank. the policies supporting the workflow are outlined and compliance with them is assessed. aims: this study aims to evaluate the process and method used to dispense and track the infusion of sipuleucel-t. methods: this is a retrospective analysis of the dispensation and administration of sipuleucel-t from january -august , which was handled exclusively by the blood bank. standard operating procedures and hospital policies were reviewed and compliance with these policies evaluated. included were patients who had the sipuleucel-t product dispensed and administered. information collected included the total number of products dispensed, patient age, adverse reactions/incidents, premedication, and patient outcome. descriptive statistics were used for data analysis. results: there were products dispensed to patients. the recipients were male patients diagnosed with prostate cancer with a mean age of years. there were doses (a complete course) administered to / ( %) recipients and a partial course ( - doses) administered to / ( %) recipients, for a total of products. the blood bank workflow treated sipuleucel-t as a derivative in the computer system, listing the manufacturer (dendreon corporation) as the supplier. health care providers were instructed to follow the nursing policy for the administration of blood products and derivatives for the infusion of sipuleucel-t. this policy required documentation of the infusion in a transfusion nursing note and reporting adverse events to the blood bank as transfusion reactions. there were no adverse events reported to the blood bank, yet there were adverse events described in provider notes; of them necessitating transfer to the emergency department, and requiring hospital admission. of the infusions, infusions were documented in a chemotherapy note rather than a transfusion note ( %), and ( %) were documented as both a transfusion and a chemotherapy administration. there were additional deviations from the blood product administration policy: cases where the consent check was not performed, case where the product was infused with ringer's lactate rather than normal saline, and cases where the -person -way check erroneously indicated the product was irradiated. summary/conclusions: this study describes one approach to managing cellular therapy products as an extension to existing blood products dispensed by a blood bank. the findings demonstrate noncompliance with hospital policy with this new product as evidenced by failure to report adverse events and failure to follow hospital practices regarding administration. although sipuleucel-t is a product manufactured from an autologous blood product donation, the administration and perceptions of this product may be more similar to a pharmaceutical. as the field of immunotherapies derived from blood product donations continues to expand, these products may necessitate an entirely new approach to ensure proper management. abstract withdrawn. (ref ) . while the mnc procedure is fully automated, cmnc requires frequent interface checks to ensure the collection of the correct cell layer. at the rambam health care campus, a tertiary care center, solely the mnc procedure had been employed till , at which point, the cmnc has been introduced for the use in patients with a white blood cell (wbc) count of ≥ , /ll on the collection day. aims: the current study aimed to compare various parameters of peripheral blood stem cell (pbsc) collection, using the cmnc protocol in allogeneic donors and patients undergoing autologous stem cell (autosc) transplantation. additionally, data on autosc collection using mnc (n = ) and cmnc (n = ) procedures were compared. methods: data were retrospectively obtained from pbsc collection reports in consecutive cmnc procedures, including autologous and allogeneic donors. the following comparisons were made: cmnc results of allogeneic versus autologous donors, a sub-analysis of cmnc results for autologous donors with a pb cd + count ≥ /ll versus allogeneic donors as well as mnc versus cmnc results in autologous donors. the collection efficiency- (ce- ) was defined as the total cd + amount in the collection bag divided by the amount of cd + cells in the pb processed by the collection apparatus. results: in the cmnc, the following parameters significantly differed between autologous and allogeneic donors: mean collection time ( ae and ae min, respectively; p = . ), the total blood volume processed ( . ae . and . ae . , respectively; p = . ) and the final volume in the collection bag ( ae and ae ml; p = . ). the mean ce- in autologous versus allogeneic donors was ae and ae , respectively (p = . ). using cmnc, the collection was effective in % of allogeneic and % of autologous donors. in autologous donors, a significantly lower collection bag volume ( ae and ae , respectively; p < . ) and increased total wbc in the collection bag ( ae versus ae , respectively; p < . ) were obtained using cmnc compared to mnc protocol. thirteen patients were treated with plerixafor due to a low pb cd + count following g-csf therapy; of them achieved a cd count ≥ and their collection was considered effective. summary/conclusions: the cmnc protocol is highly effective in terms of the cell yield in both allogeneic and autologous donors with a pb cd + count ≥ /ll. significantly superior collection results are obtained in allogeneic donors versus autologous ones. cmnc provides a significantly higher wbc and a lower final collection volume than mnc. similar total cd + cell counts are obtained with both methods. . tbv processed ranged from - . tbv with mean of . , average was . tbv for females and . tbv for males mean pre-apheresis cd + count was . cells/ll (range . - . ). mean postapheresis cd + count was . cells/ll ( . - . ). mean cd + cells x / kg recipients body weight was . (range: . - . ). our target yield was ≥ cd + cells/kg body weight of the recipient and in only / ( %) cases, the yield was < . / ( . %) procedures were lvl and / ( . %) were svl. summary/conclusions: most of our pbsc were done for haematological indications ( . %) and the target dose was cells/ll in single leukapheresis. in cases ( %), target yield was achieved, only cases had < but > yield. in our study donors < years have shown to mobilize better than the older children. hematocrit (hct) and weight showed correlation with cd + cell yield but they cannot be taken absolute predictors. wbc count cannot be taken as a predictor for cd yield as high wbc count did not convert into high cd yield or vice versa. high prepheresis cd + count gave higher postpheresis cd + count. large volume leukapheresis (lvl), > tbv gave higher yield as compared to standard volume leukapheresis (svl). blood volume processed related to prepheresis cd + count and/or the weight difference between the donor and recipient. other parameters like hematocrit, wbc count, age etc did not show correlation to the volume processed. in our study, younger age and prepheresis cd + count were found as the most relevant predictors for stem cell yield. background: allogeneic hematopoietic stem cell transplantation is an established therapy for many hematologic disorders. since the discoveries of the potential of peripheral blood stem cells (pbsc) in the hematopoietic reconstitution mid s and early s pbsc gradually replaced bone marrow as the preferred source of stem cells. the introduction of hematopoietic cytokines that can mobilize large number of progenitors into circulation accelerated pbsc usage. aims: the aim of our study is to present our year experience with apheresis collecting of pbsc in donors. methods: this is a retrospective study performed in the institute for transfusion medicine of republic of macedonia and university hematology hospital for period background: obtaining unambiguous results of hla typing plays an important role in the transplantation of hematopoietic stem cells. appropriate selection of alleles in the level of hla between recipients and unrelated bone marrow donors reduces the risk of transplant rejection and graft-versus-host disease. new generation technology ensures the highest possible resolution and obtaining unambiguous genotyping results due to the high complexity of the hla system. currently, this is the selection method for obtaining hla test results at the high resolution level. aims: the aim of this study was to determine hla loci (hla-a, -b, -c, drb / / / , dqb , dpb , dpa , dqa ) in potential bone marrow donors from poland. the research included , potential bone marrow donors registered between and . a novelty of this paper was that the amplification of all hla loci was performed by using multiplex pcr primers in a single tube. that solution completely eliminated the need to pool amplicons. methods: the typing of the hla loci (hla-a, -b, -c, drb / / / , dqb , dpb , dpa , dqa ) of potential bone marrow donors was made by using the alltype tm ngs -loci amplification kit (one lambda). genomic dna was isolated from peripheral blood of , donors. hla genotypes were determined according to the manufacturer's protocol on the miseq illumina platform. the obtained sequencing data was evaluated by using the typestream tm visual ngs analysis software. results: the ngs method allowed to obtaining unambiguous results of genotyping of potential bone marrow donors, and also provided the identification of rare alleles, such as: c* : , c* : , c* : , c* : , drb * : , c* : , b* : , c* : , dqb * : , drb * : , drb * : . summary/conclusions: . new generation sequencing technology (ngs), which is based on pcr, ensures the highest possible resolution. . the ngs method allows to obtain more accurate sequencing results compared to the conventional methods. . the research has confirmed the superiority of the ngs method over conventional methods in obtaining unambiguous hla genotyping results at the high resolution level. background: the accurate results of hla typing are significant for ensuring the success rate of hematopoietic stem cell transplantation. currently, hla typing is mainly based on sanger sequencing, which has a high proportion of ambiguous combination results indicating potential errors for hla typing. it is necessary for finding a more accurate typing method to reduce the risk. next-generation sequencing (ngs) method could provide clonal sequencing of single molecules, which has been used for hla genotyping and improved the scope and precision of hla study. aims: to establish a full-length precision sequencing platform for hla-i gene (hla-a, -b, -c) based on ngs technology and be evaluated by classical sangersequencing method, which can effectively improve the accuracy of hla typing for donor and recipient in hematopoietic stem cell transplantation. methods: hla-i (hla-a, -b, -c) gene-specific primers were screened, and the amplification parameters were optimized to obtain full-length sequences of hla-i gene under the same condition. the sample library for the amplicon was prepared with transngs tn dna library prep kit and the sequencing step was carried out with illumina miseq platform according to the manufacturer' protocol. all the sequencing data in fastq format were analyzed by typestream visual software version . . (one lambda inc.)with the default setting. cord blood samples were collected for hla typing with the mentioned above next-generation sequencing method in our study. in parallel, all the sample were also tested with the sanger sequencing method according to the previous study in our laboratory. results: samples were successfully tested with two methods and the coincidence rate between two sequencing methods was %. with the next-generation sequencing method, the probability of ambiguous results among samples in our study is . %( / ) for hla-a, . % ( / ) for hla-b and % ( / )for hla-c. however, the probability of ambiguous results with the sanger sequencing method is . % for hla-a, . % for hla-b, % for hla-c. summary/conclusions: the full-length precision sequencing platform for hla-i gene (hla-a, -b, -c) based on ngs technology was established, which could greatly reduce the probability of ambiguous results and effectively improve the accuracy of existing hla typing techniques. key: cord- - ghtmhu authors: chua, kaw bing; gubler, duane j title: perspectives of public health laboratories in emerging infectious diseases date: - - journal: emerg microbes infect doi: . /emi. . sha: doc_id: cord_uid: ghtmhu the world has experienced an increased incidence and transboundary spread of emerging infectious diseases over the last four decades. we divided emerging infectious diseases into four categories, with subcategories in categories and . the categorization was based on the nature and characteristics of pathogens or infectious agents causing the emerging infections, which are directly related to the mechanisms and patterns of infectious disease emergence. the factors or combinations of factors contributing to the emergence of these pathogens vary within each category. we also classified public health laboratories into three types based on function, namely, research, reference and analytical diagnostic laboratories, with the last category being subclassified into primary (community-based) public health and clinical (medical) analytical diagnostic laboratories. the frontline/leading and/or supportive roles to be adopted by each type of public health laboratory for optimal performance to establish the correct etiological agents causing the diseases or outbreaks vary with respect to each category of emerging infectious diseases. we emphasize the need, especially for an outbreak investigation, to establish a harmonized and coordinated national public health laboratory system that integrates different categories of public health laboratories within a country and that is closely linked to the national public health delivery system and regional and international high-end laboratories. infectious diseases have affected humans since the first recorded history of man. infectious diseases remain the second leading cause of death worldwide despite the recent rapid developments and advancements in modern medicine, science and biotechnology. greater than million (. %) of an estimated million deaths that occur throughout the world annually are directly caused by infectious diseases. millions more deaths are due to the secondary effects of infections. moreover, infectious diseases cause increased morbidity and a loss of work productivity as a result of compromised health and disability, accounting for approximately % of all disability-adjusted life years globally. , compounding the existing infectious disease burden, the world has experienced an increased incidence and transboundary spread of emerging infectious diseases due to population growth, urbanization and globalization over the past four decades. [ ] [ ] [ ] [ ] [ ] [ ] most of these newly emerging and re-emerging pathogens are viruses, although fewer than of the approximately pathogen species recognized to infect humans are viruses. on average, however, more than two new species of viruses infecting humans are reported worldwide every year, most of which are likely to be rna viruses. emerging novel viruses are a major public health concern with the potential of causing high health and socioeconomic impacts, as has occurred with progressive pandemic infectious diseases such as human immunodeficiency viruses (hiv), the recent pandemic caused by the novel quadruple re-assortment strain of influenza a virus (h n ), and more transient events such as the outbreaks of nipah virus in / and severe acute respiratory syndrome (sars) coronavirus in . [ ] [ ] [ ] [ ] [ ] in addition, other emerging infections of regional or global interest include highly pathogenic avian influenza h n , henipavirus, ebola virus, expanded multidrug-resistant mycobacterium tuberculosis and antimicrobial resistant microorganisms, as well as acute hemorrhagic diseases caused by hantaviruses, arenaviruses and dengue viruses. to minimize the health and socioeconomic impacts of emerging epidemic infectious diseases, major challenges must be overcome in the national and international capacity for early detection, rapid and accurate etiological identification (especially those caused by novel pathogens), rapid response and effective control (figure ). the diagnostic laboratory plays a central role in identifying the etiological agent causing an outbreak and provides timely, accurate information required to guide control measures. this is exemplified by the epidemic of nipah virus in malaysia in / , which took more than six months to effectively control as a consequence of the misdiagnosis of the etiologic agent and the resulting implementation of incorrect control measures. , however, there are occasions when control measures must be based on the epidemiological features of the outbreak and pattern of disease transmission, as not all pathogens are easily identifiable in the early stage of the outbreak (figure ). establishing laboratory and epidemiological capacity at the country and regional levels, therefore, is critical to minimize the impact of future emerging infectious disease epidemics. developing such public health capacity requires commitment on the part of all countries in the region. however, to develop and establish such an effective national public health capacity, especially the laboratory component to support infectious disease surveillance, outbreak investigation and early response, a good understanding of the concepts of emerging infectious diseases and an integrated country and regional public health laboratory system in accordance with the nature and type of emerging pathogens, especially novel ones, are highly recommended. traditionally, emerging infectious diseases are broadly defined as infections that: (i) have newly appeared in a population; (ii) are increasing in incidence or geographic range; or (iii) whose incidence threatens to increase in the near future. , six major factors, and combinations of these factors, have been reported to contribute to disease emergence and re-emergence: (i) changes in human demographics and behavior; (ii) advances in technology and changes in industry practices; (iii) economic development and changes in land use patterns; (iv) dramatic increases in volume and speed of international travel and commerce; (v) microbial mutation and adaptation; and (vi) inadequate public health capacity. , from the perspective of public health planning and preparedness for effective emerging infectious disease surveillance, outbreak investigation and early response, the above working definition of emerging infectious disease and its associated factors that contribute to infectious disease emergence are too broad and generic for more specific application and for the development of a national public health system, especially in the context of a public health laboratory system in a country. thus, in this article, emerging infectious diseases are divided into four categories based on the nature and characteristics of pathogens or infectious agents causing the emerging infections; these categories are summarized in table . the categorization is based on the patterns of infectious disease emergence and modes leading to the discovery of the causative novel pathogens. the factors or combinations of factors contributing to the emergence of these pathogens also vary within each category. likewise, the strategic approaches and types of public health preparedness that need to be adopted, in particular with respect to the types of public health laboratories that need to be developed for optimal system performance, will also vary greatly with respect to each category of emerging infectious diseases. these four categories of emerging infectious diseases and the factors that contribute to the emergence of infectious diseases in each category are briefly described below. [ ] [ ] [ ] [ ] [ ] [ ] factors that contributed to the occurrence of emerging infectious diseases in this subcategory include population growth; urbanization; environmental and anthropogenic driven ecological changes; increased volume and speed of international travel and commerce with rapid, massive movement of people, animals and commodities; and deterioration of public health infrastructure. subcategory b includes known and unknown infectious agents that occur in new host 'niches'. infectious microbes/ agents placed under this subcategory are better known as 'opportunistic' pathogens that normally do not cause disease in immunocompetent human hosts but that can lead to serious diseases in immunocompromised individuals. the increased susceptibility of human hosts to infectious agents is largely due to the hiv/acquired immune deficiency syndrome pandemic, and to a lesser extent, due to immunosuppression resulting from cancer chemotherapy, antirejection treatments in transplant recipients, and drugs and monoclonal antibodies that are used to treat autoimmune and immune-mediated disorders. a notable example is the increased incidence of progressive multifocal leukoencephalopathy, a demyelinating disease of the central nervous system that is caused by the polyomavirus 'jc' following the public health laboratories in emerging infectious diseases kb chua and dj gubler increased use of immunomodulatory therapies for anti-rejection regimens and for the treatment of autoimmune diseases. examples of past emerging infectious diseases under this category are antimicrobial resistant microorganisms (e.g., mycobacterium tuberculosis, plasmodium falciparum, staphylococcus aureus) and pandemic influenza due to a new subtype or strain of influenza a virus (e.g., influenza virus a/california/ / (h n )). , - factors that contribute to the emergence of these novel phenotype pathogens are the abuse of antimicrobial drugs, ecological and host-driven microbial mixing, microbial mutations, genetic drift or re-assortment and environmental selection. accidental or potentially intentional release of laboratory manipulated strains resulting in epidemics is included in this category. factors that lead to the spillovers and emergence of these novel pathogens are human population expansion, economic development, changes in land use patterns, modifications to natural habitats, and changes in agricultural practices and animal husbandry. human behavior, such as wildlife trade and translocations, live animal and bush meat markets, consumption of exotic foods, development of ecotourism, access to petting zoos and ownership of exotic pets, also plays a significant role in the transfer of pathogens between species. [ ] [ ] [ ] [ ] [ ] [ ] examples of infectious diseases under category b are gastritis and peptic ulcers due to helicobacter pylori, kaposi sarcoma due to human herpesvirus and chronic hepatitis due to hepatitis virus c and g. [ ] [ ] [ ] [ ] advances in scientific knowledge and technology have contributed substantially to the discovery of these infectious etiological agents. regardless of the category, with some exception for category b, effective early detection, identification, characterization, containment, control and ultimately prevention of the emerging infectious diseases will require a good, functional national public health surveillance system. the system needs to be well supported by a network of primary public health and clinical/medical diagnostic laboratories that are coordinated by a national public health reference laboratory with real-time and harmonious communication between the laboratories and epidemiological surveillance units. confronted with the great diversity of these emerging pathogens and the equally diverse mechanisms and factors that are responsible for their emergence, there is an urgent need to develop a network of diagnostic laboratories, especially in countries where epidemic infectious diseases are likely to emerge. this network should include local laboratories with basic clinical laboratory capabilities, provincial and national public health diagnostic laboratories with greater capability to diagnose known pathogens and support effective laboratory-based surveillance, and a centralized national reference laboratory that can provide laboratory training and quality control for diagnostic assays for the network of diagnostic laboratories in the country. ideally, the national reference laboratory should have state-of-the-art laboratory technology and be able to identify and characterize novel pathogens with specialized university laboratories and foreign institutes that can provide backup capability, but more importantly, the national reference laboratory should be able to conduct research for the development of new diagnostic technologies to detect and identify novel pathogens, especially those classified as category . the us system, which includes local and state public health laboratories that conduct diagnoses of known pathogens, the centers for disease control and prevention and university laboratories that provide research and reference activities, is a good model. disease or pathogen-specific public health diagnostic laboratories established to support world health organization (who)-specific disease surveillance programs and vaccine-preventable diseases, e.g., national influenza, poliovirus and measles laboratories, led to the 'compartmentalization' of laboratory diagnostic services, segregation of functions, and duplication of facilities and equipment. the situation is further complicated by the siting of various pathogen-specific diagnostic laboratories in different buildings or institutes or different locations within a country, thus preventing more cost-effective measures of sharing common equipment and reagents, clinical samples, information and human resources. finally, the problem is compounded by policy makers and laboratory managers lacking flexibility and not allowing these disease or pathogen-specific laboratories to adopt a more generic approach in the investigation of infectious disease outbreaks. past incidents have shown that misdiagnosis or delay in the diagnosis of epidemics can cause substantial economic losses and social disruption and prevent containment or control as a result of the implementation of inappropriate control measures or a delay in implementing the appropriate control measures. the proposed integrated system of public health laboratories is not entirely new; public health laboratories are already in existence in most countries, but most are poorly equipped and are not adequately funded or staffed with trained professional staff. moreover, a lack of knowledge and coordination has led to ineffective operation in the support of infectious disease surveillance. the basic concept of realigning and harmonizing public health laboratories to optimize their roles and functions can be drawn from the system of medical practices. due to rapid and vast expansion of medical knowledge, technology and demand of specialized skills and therapy, medical practices have evolved into a number of specialties and subspecialties, such as infectious disease, cardiology, gastroenterology, neurology, radiology, anesthesiology and oncology. an excellent aspect of the medical system is the continual retention of the general physician (family physician) or general pediatrician as the initial or first entry point for patients seeking consultation for any medical problem before being subsequently referred to the appropriate specialist, if deemed necessary. it is not uncommon for patients, especially older individuals, to have more than one disease or pathology at the time of presentation to the doctor. in a similar manner, in outbreaks of infectious diseases, 'background' endemic pathogens are often present that are capable of similar disease manifestations. thus, public health analytical diagnostic laboratories (both primary and clinical) should adopt a generic approach and serve as the initial or first entry point for the investigation of the causative pathogens in the event of an infectious disease outbreak or the occurrence of any fatal illness with clinical suspicion of infectious etiology. in addition, public health laboratories must have the capability to support the expanded scope and sophistication of public health activities brought about by a rapid increase in population and social, demographic and ecological changes, in addition to the factors mentioned above. despite the presence of several types of health laboratories, they can be classified into three main categories: (i) public health research laboratories; (ii) public health reference laboratories; and (iii) public health analytical diagnostic laboratories. public health analytical diagnostic laboratories can be further subcategorized into primary public health (community-based) and clinical/medical (hospital and clinic-based) analytical diagnostic laboratories. a proposed organizational model to establish an integrated system of public health laboratories within a country to coordinate and link health laboratories under different ministries and in both public and private institutions based on their functional roles is shown in figure . the broken lines indicate the diagnostic laboratories that are not directly regulated by the ministry of health. a schematic flow chart illustrating the functional relationships and linkages between various types of public health laboratories in a country was described previously. a defined and harmonious linkage and collaboration will not only avoid duplication and redundancy, but also enhance and complement the function and output quality of each laboratory. bearing in mind that not all countries in the world have similar resources (financial, man-power and expertise), demography, geopolitical structure, needs and commitment, the proposed model can be appropriately modified to tailor each country's immediate needs with a provision for future upgrading and expansion. ultimately, it is recommended that all countries establish an integrated system covering all three categories of public health laboratories, with a cohesive centralized national public health reference laboratory. in countries with limited resources, an interim centralized national public health diagnostic laboratory can take on some of the roles and functions of a national reference laboratory, especially in supporting laboratory training and quality assurance. for countries without such an idealistic centralized public health reference laboratory, an in-place system of networking should be developed to link to regional and international high-end laboratories or who collaborative centers to rapidly identify and characterize novel pathogens and provide other specialized laboratory diagnostic reagents, assays or validation. in addition, each region should have a regional center for reference public health laboratories in emerging infectious diseases kb chua and dj gubler and research to help the national reference and/or diagnostic laboratories train and maintain laboratory quality control. the us centers for disease control and prevention is a major who collaborative partner and provides laboratory service not only for the american region, but also for many other countries in the world. investigations into the diagnosis of nipah virus, sars coronavirus, pandemic influenza a virus and hemorrhagic fever viruses are just a few examples illustrating its worldwide function. the placement of the centralized reference laboratory under the national center for disease control strengthens close communication and coordination among public health specialists, epidemiologist and laboratory personnel and serves as an important coordinating center to support the functions and activities pertaining to biorisk issues, centralized pathogen characterization and storage, laboratory-based surveillance and laboratory quality assurance, as shown in figure . a national reference laboratory will also be able to play an important role as part of a regional laboratory network to strengthen regional public health laboratory capacity in providing specific referral functions for public health diagnostic laboratories in other countries that do not have a reference laboratory. the public health research laboratories within the research institutes of ministries of health and universities or even private research institutions are best suited and can play a crucial role in collaborating with the national public health reference and diagnostic laboratories to discover novel pathogens of many human diseases under category , especially in subcategory b. the proposed network scheme will provide more cost-efficient laboratory services and ensure a regular flow of laboratory work to maintain the competency of technical staff to produce quality output. because of the increased likelihood of epidemic diseases caused by novel pathogens, diagnostic laboratories serving as the primary entry point of investigation should be able to take a more generic approach in pathogen detection, isolation and identification. the traditional existing system of 'compartmentalization' of national disease/pathogenspecific diagnostic laboratories should thus be reviewed and integrated into the national public health infectious disease diagnostic laboratory system. this proposed model would improve cost-efficiency and allow a more appropriate approach to infectious disease outbreak investigation and control. we thank tikki pang, lee kuan yew school of public policy, national university of singapore, for useful comments and suggestions in the preparation of this manuscript. emerging infections: getting ahead of the curve emerging infectious diseases: a -year perspective from the national institute of allergy and infectious diseases emerging viruses: 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viruses for old disease? a previously unknown reovirus of bat origin is associated with an acute respiratory disease in humans identification and characterization of a new orthoreovirus from patients with acute respiratory infections saffold virus, a human theiler's-like cardiovirus, is ubiquitous and causes infection early in life unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration identification of herpesvirus-like dna sequences in aids-associated kaposi's sarcoma isolation of a cdna clone derived from a blood-borne non-a, non-b viral hepatitis genome molecular cloning and disease association of hepatitis g virus: a transfusion-transmissible agent this work is licensed under a creative commons attribution-noncommercial-noderivative works to view a copy of this license key: cord- -xit najq authors: van damme, wim; dahake, ritwik; delamou, alexandre; ingelbeen, brecht; wouters, edwin; vanham, guido; van de pas, remco; dossou, jean-paul; ir, por; abimbola, seye; van der borght, stefaan; narayanan, devadasan; bloom, gerald; van engelgem, ian; ag ahmed, mohamed ali; kiendrébéogo, joël arthur; verdonck, kristien; de brouwere, vincent; bello, kéfilath; kloos, helmut; aaby, peter; kalk, andreas; al-awlaqi, sameh; prashanth, ns; muyembe-tamfum, jean-jacques; mbala, placide; ahuka-mundeke, steve; assefa, yibeltal title: the covid- pandemic: diverse contexts; different epidemics—how and why? date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: xit najq it is very exceptional that a new disease becomes a true pandemic. since its emergence in wuhan, china, in late , severe acute respiratory syndrome coronavirus (sars-cov- ), the virus that causes covid- , has spread to nearly all countries of the world in only a few months. however, in different countries, the covid- epidemic takes variable shapes and forms in how it affects communities. until now, the insights gained on covid- have been largely dominated by the covid- epidemics and the lockdowns in china, europe and the usa. but this variety of global trajectories is little described, analysed or understood. in only a few months, an enormous amount of scientific evidence on sars-cov- and covid- has been uncovered (knowns). but important knowledge gaps remain (unknowns). learning from the variety of ways the covid- epidemic is unfolding across the globe can potentially contribute to solving the covid- puzzle. this paper tries to make sense of this variability—by exploring the important role that context plays in these different covid- epidemics; by comparing covid- epidemics with other respiratory diseases, including other coronaviruses that circulate continuously; and by highlighting the critical unknowns and uncertainties that remain. these unknowns and uncertainties require a deeper understanding of the variable trajectories of covid- . unravelling them will be important for discerning potential future scenarios, such as the first wave in virgin territories still untouched by covid- and for future waves elsewhere. late in , a cluster of acute respiratory disease in wuhan, china, was attributed to a new coronavirus, - later named severe acute respiratory syndrome coronavirus (sars-cov- ). it was soon discovered that the virus is easily transmitted, can cause summary box ► severe acute respiratory syndrome coronavirus (sars-cov- ), the virus that causes covid- , has spread to nearly all countries of the world in only a few months. it is unique that an emerging respiratory virus becomes a pandemic, and can continue human-to-human transmission unabated, probably permanently. ► depending on the context, the trajectory and the impact of the covid- epidemic vary widely across affected countries. this is in fact the case with most infectious diseases. ► despite limited initial knowledge on covid- , most societies have deployed draconian measures, including lockdowns, to contain the virus and mitigate its impact. this had variable success, but invariably with profound socioeconomic collateral effects. ► through research and rapid sharing of its findings, progressively more insights on sars-cov- and covid- have been uncovered (knowns), mainly based on evidence from china, europe and the usa; however, important knowledge gaps remain (unknowns). ► the different covid- epidemics and the responses unfolding in the global south are little described, analysed or understood. insights from these less researched contexts are important for discerning potential future scenarios, not only for the first wave in virgin territories still untouched by covid- , but also for future waves. ► more understanding of lived experiences of people in a variety of contexts is necessary to get a full global picture and allow learning from this variety. ► bmj global health and emerging voices for global health have launched a call for such on-the-ground narratives and analyses on the epidemics of, and responses to, covid- . severe disease and can be quite lethal especially in the elderly and those with comorbidities. [ ] [ ] [ ] [ ] the new human disease is called covid- . soon it became clear that its global spread was unstoppable. even with draconian containment measures, such as strict movement restrictions, the so-called lockdown, it spread, and within a few months reached almost all countries and was declared a pandemic by the who. table summarises key events in the unfolding of the covid- pandemic, from december to may . this progression is quite unique. new human pathogens emerge frequently from an animal host, but most cause only a local outbreak. human-to-human transmission stops at some point, and the virus can only re-emerge as a human pathogen from its animal host. only very rarely does an emerging pathogen become a pandemic. over the past decades, a totally new pathogen emerged, caused serious disease, and spread around the globe continuously only once before: the hiv. it seems increasingly likely that sars-cov- transmission will be continuing. all countries are now facing their own 'covid- epidemic'. in only a few months, the scientific community has started to learn the virus's characteristics and its manifestations in different contexts. but we fail to understand fully why the virus spreads at different speeds and affects populations differently. our main objective is to make sense of those different expressions of the covid- pandemic, to understand why covid- follows variable trajectories in ways that are often quite different from the collective image created by the mediatisation of the dramatic covid- epidemics in densely populated areas. we start by exploring the role of context, followed by a brief summary of what is already known at the time of writing about sars-cov- and covid- . we then bmj global health compare these knowns with what is known of some other viral respiratory pathogens and identify the critical unknowns. we also discuss the coping strategies and collective strategies implemented to contain and mitigate the effect of the epidemic. we finally look ahead to potential future scenarios. the unfolding covid- pandemic: importance of context initially, human-to-human transmission was documented in family/friends clusters. [ ] [ ] [ ] [ ] [ ] [ ] progressively, it became clear that superspreading events, typically during social gatherings such as parties, religious services, weddings, sports events and carnival celebrations, have played an important role. [ ] [ ] [ ] [ ] dense transmission has also been documented in hospitals and nursing homes possibly through aerosols. sars-cov- has spread around the world through international travellers. the timing of the introduction of sars-cov- has largely depended on the intensity of connections with locations with ongoing covid- epidemics; thus, it reached big urban centres first and, within these, often the most affluent groups. from there, the virus has spread at variable speeds to other population groups. as of may , the most explosive covid- epidemics observed have been in densely populated areas in temperate climates in relatively affluent countries. the covid- pandemic and the lockdowns have been covered intensively in the media and have shaped our collective image of the covid- epidemic, both in the general public and in the scientific community. the covid- epidemic has spread more slowly and less intensively in rural areas, in africa and the indian subcontinent, and the rural areas of low and lower-middle income countries (lics/lmics). not only the media but also the scientific community has paid much less attention to these realities, emerging later and spreading more slowly. the dominant thinking has been that it is only a question of time before dramatic epidemics occur everywhere. this thinking, spread globally by international public health networks, has been substantiated by predictive mathematical models based largely on data from the epidemics of the global north. however, what has been observed elsewhere is quite different although not necessarily less consequential. the effects of the covid- epidemic manifest in peculiar ways in each context. in the early stages of the covid- epidemic in sub-saharan africa, the virus first affected the urban elites with international connections. from there, it was seeded to other sections of the society more slowly. in contrast, the collateral effects of a lockdown, even partial in many cases, are mostly felt by the urban poor, as 'stay home' orders abruptly intensify hardship for those earning their daily living in the informal urban economy. governments of lics/lmics lack the budgetary space to grant generous benefit packages to counter the socioeconomic consequences. international agencies are very thinly spread, as the pandemic has been concurrent everywhere. donor countries have focused mainly on their own covid- epidemics. the epidemic is thus playing out differently in different contexts. many factors might explain sars-cov- transmission dynamics. climate, population structure, social practices, pre-existing immunity and many other variables that have been explored are summarised in table . although all these variables probably play some role, many uncertainties remain. it is difficult to assess how much these variables influence transmission in different contexts. it is even more difficult to assess how they interact and change over time and influence transmission among different social groups, resulting in the peculiar covid- epidemic in any particular context. we do not attempt to give a complete overview of viruses but select only those viruses that emerged recently and caused epidemics such as ebola, that have obvious similarities in transmission patterns such as influenza and measles, or that are closely related such as other coronaviruses. respiratory viruses such as severe acute respiratory syndrome coronavirus (sars-cov), middle east respiratory syndrome coronavirus (mers-cov) and avian influenza a and also ebola have originated from animal hosts and caused human diseases (table ) . these viruses do not continuously circulate from human to human. they create an outbreak only when there is interspecies cross-over transmission, most frequently from bats to another animal host. the first human case of a disease from an emerging viral pathogen, the 'index case' or 'patient zero', is invariably someone in close contact with the originating animal host or an intermediary animal host. if this contact occurs in a remote rural community, the spread is usually slow, at low intensity, and could fade out before the pathogen gets a chance to spread to another community. the spread can suddenly intensify if seeded in a densely populated community, frequently in a particular context such as a hospital or during a social event, often referred to as a superspreading event. when the spread reaches a city, it can become a major outbreak, from where it can spread further; this happened with sars-cov in hong kong in and with ebola in conakry, freetown and monrovia in - . but at some stage human-to-human transmission is interrupted and the outbreak stops. only very exceptionally can a new viral pathogen sustain continuous human-to-human transmission. other viral diseases such as measles and influenza are 'old' diseases; they have been studied in great depth. what can we learn from them? measles and influenza: the importance of context it is thought that measles emerged thousands of years ago in the middle east. it is assumed that a cross-over occurred from the rinderpest virus, to become the human measles virus. measles has since spread around the globe in continuous human-to-human transmission. when measles, along with other viruses such as smallpox and influenza, was introduced in the americas by european conquerors, it contributed to a massive die-off of up to % of the original population. the transmission dynamics of sars-cov- can be compared with influenza. influenza typically causes yearly epidemics in temperate climates during winter with less seasonal patterns in tropical or subtropical regions. in hotter climates, such as in sub-saharan africa or south and southeast asia, it is transmitted year round, often not identified as influenza. such different epidemic patterns of influenza are still incompletely understood but thought to be associated with temperature and humidity and human behavioural factors such as indoor crowding. but, in contrast to sars-cov- , the influenza virus is not new. influenza is a very old disease, certainly circulating for several centuries. it has infected most human beings living on the planet already, many of them several times, leaving some immunity but no durable protection. the virus also mutates, giving rise to a new dominant strain every influenza season. influenza is every year a slightly different virus (due to antigenic drift as a result of progressive mutations) with major differences every few decades (antigenic shift as a result of recombination with novel strains). one such antigenic shift resulted in the h n 'spanish' influenza pandemic, which had an estimated case fatality rate (cfr) of %- %, killing millions. box summarises some key facts about h n , including factors thought to be associated with its high cfr. a major difference between covid- and influenza is that sars-cov- is a new pathogen and influenza is not. at the time of writing (may ), sars-cov- has triggered an immune response in over million confirmed infections (and probably in many more), definitely too few to create anything close to herd immunity. calculations using an estimated reproductive number (r ) for sars-cov- suggest that herd immunity would require at least % of the population to have protective immunity (see box ). like covid- , measles and influenza have different epidemic patterns in different contexts. this also is the case for cholera, tuberculosis, hiv/aids and most infectious diseases. the difference in patterns is most pronounced and so is easily understood with vectorborne and water-borne diseases. epidemic patterns are also different for air-borne infections, although they are less easily understood. transmission of respiratory viruses is influenced by factors related to the virus and box pandemic h n influenza, - ► the h n virus probably infected one-third of the world's population at that time (or ~ million people). ► the pandemic had three waves in quick succession; the second wave, in , was worse than the first wave. ► high mortality, especially in younger persons ( - years; ~ % of total deaths) in the pandemic, may have been due to antibody-dependent enhancement and 'cytokine storms'. another possible explanation is that older persons had some protective cross-immunity from previous influenza outbreaks while younger persons did not. ► h n continued to circulate along with seasonal influenza viruses, often recombining to produce more severe local outbreaks, including other pandemics between and , giving it the nickname 'mother of all pandemics'. ► the original h n strain was replaced by a(h n )pdm virus that resulted from an antigenic shift and caused the h n influenza pandemic. ► the h n virus originated in pigs in central mexico in march and was responsible for an estimated deaths worldwide with an estimated cfr< . %. ► during the pandemic, mortality was much lower than in the pandemic. higher mortality in persons younger than years was related to cytokine storms. a role of protective crossimmunity from previous influenza strains in older persons has been suggested. ► after august , the a(h n )pdm virus appeared to have integrated with circulating strains of influenza and continues to cause localised seasonal influenza outbreaks worldwide. box on the use of mathematical models during epidemics a dominant way of studying the transmission dynamics of an infectious disease such as covid- , and predicting the amplitude and peak of the epidemic in a population (city, province, country) and analysing the effect of control measures is using mathematical models. based on available data and several assumptions, a model attempts to predict the course of the epidemic, the expected number of infections, clinical cases and deaths over time. critical is the effective reproductive number (rt). when rt > , the number of cases in a population increases; when rt < , the number of cases decreases. a relatively simple and widely used model is the susceptible-exposed-infectious-recovered model, as used in the two papers recently published in bmj global health on covid- in africa. there are many more types of models, with varying degrees of complexity. the use of such models has strengths and limitations. building a mathematical model implies trade-offs between accuracy, transparency, flexibility and timeliness. a difficulty, in general, is that the parameters on which the model is based, the so-called assumptions are frequently uncertain (table ) and predictions can vary widely if any of the parameters are modestly different. this uncertainty is captured in a sensitivity analysis, leading to various possible quantitative outcomes, usually expressed as a range of plausible possibilities, between 'worst-case' and 'best-case' scenarios. with a new disease such as covid- , certainly at the start of the outbreak, the parameters had to be based on very limited data from a particular context. however, many variables can widely differ across communities as they critically depend on contextual factors (table ) . in mathematical models, all such uncertainties and unknowns are somehow hidden in the complex formulae of the model, as a quasi 'black box'. few people have the knowledge and skill to 'open up the black box'. as uncertainties in covid- are large, the range of possibilities produced by a model is wide, with the worst-case scenario typically predicting catastrophic numbers of cases and deaths. such predictions are often misunderstood by journalists, practitioners and policy-makers, with worst-case estimates getting the most attention, not specifying the huge uncertainties. bmj global health the human host but also by factors related to the natural and human environment (table ) . however, we are quite unable to explain fully which factor has which influence, how these factors vary among different social groups and how interdependent or isolated they are. we are certainly unable to fully model all these variables mathematically to explain the epidemic pattern across a variety of different contexts. too many variables and their interrelations are difficult to quantify, and when all these factors change over time while the pathogen continues to spread in diverse societies, the complexity becomes daunting. understanding transmission dynamics is a bit less daunting for measles, as several variables are well known and rather constant across individuals and contexts. the natural transmission pattern of measles, before the introduction of vaccines, has been well described. measles is mostly a childhood disease, but this is not the case in very remote communities, where measles transmission had been interrupted for extended periods (such as the faroe islands). measles affected all age groups when reaching new territories, causing dramatic first-wave epidemics, a phenomenon called 'virgin soil epidemic'. the latest stages of the global dissemination of measles have been well documented, including in australia, the fiji islands and the arctic countries, where such virgin soil epidemics occurred in the th and the mid- th centuries. fortunately, measles infection creates robust protective immunity and after a first wave becomes a typical childhood disease, affecting only those without any prior immunity. human-to-human transmission of measles virus in a community stops when the virus cannot find new susceptible human hosts and the so-called herd immunity is reached. but transmission of measles continues elsewhere on the planet from where it can be reintroduced a few years later when the population without protective immunity has grown large enough to allow human-to-human transmission again. the epidemic patterns of measles are easily understood as measles is highly infectious, creates disease in almost every infected person and leaves lifelong natural immunity. measles circulation, prior to vaccination, was continuous only in large urban areas with high birth rates. everywhere else reintroduction occurred typically every - ► genetic stability or variability (affecting the potential of long-lasting immunity). ► viral load determines the incubation period with the formula high load ->short incubation period ->high severity. human host ► human susceptibility to the virus; transfer of parental immunity to newborns. ► route and efficiency of human-to-human transmission. ► presence and capacity of asymptomatic carriers to transmit the virus. ► immunity created after infection, its robustness and how long-lasting it is. ► severity and duration of the disease: proportion symptomatic, lethality (cfr). ► pathogenicity and disease spectrum; disease pattern according to age and comorbidities, and related potential to spread. natural environment ► temperature, humidity and seasonal changes in climate affecting the stability and transmission potential of the virus and human susceptibility. ► increasing extreme weather conditions such as droughts and severe storms, as well as global climate change may also affect transmission patterns. ► air pollution may also play a role in the transmission and stability of the virus. human environment/social geography ► demographic variables such as population density, age structure and household composition. ► mixing patterns within households, including bed sleeping patterns, related to housing conditions and hygiene practices. ► house construction with solid walls or permeable walls (thatched walls, straw mats). ► mixing patterns among households related to settlement patterns: social networks, urban-rural differences, working conditions, religious practices and commuting patterns. ► variables related to built environments, road infrastructure and socioeconomic conditions. ► mobility between communities, including international travel. ► crowding institutions: for example, elderly homes, extended families, boarding schools, child institutions, seclusion during tribal ceremonies, hospitals, nursing homes, military barracks and prisons. cfr, case fatality rate. years but sometimes only after or years in isolated rural communities (such as among nomadic groups in the sahel), causing epidemics among all those without acquired immunity and having lost maternal antibodies. these diverse patterns of measles epidemics have been fundamentally changed by variable coverage of measles vaccination. they can still help us make sense of the diversity of covid- epidemics being observed in . measles illustrates convincingly that the transmission pattern of a respiratory virus is strongly influenced by the demographic composition, density and mixing pattern of the population and the connectedness to big urban centres. measles transmission is continuous only in some large urban areas. it presents in short epidemics everywhere else with variable periodicity. this transmission pattern may well be a bit similar for covid- . but it took thousands of years for measles to reach all human communities while sars-cov- spread to all countries in only a few months, despite measles being much more transmissible than sars-cov- . factors such as increased air travel and more dense community structures play bigger roles for sars-cov- than they did for measles. comparison with other pathogenic coronaviruses sars-cov- has many close relatives. six other human coronaviruses (hcovs) are known to infect humans. sars-cov and mers-cov (causing sars and mers, respectively) are very rare and do not continuously circulate among humans. the other four (hcov- e, hcov-oc , hcov-hku and hcov-nl ) cause the common cold or diarrhoea and continuously circulate and mutate frequently. they can cause disease in the same person repeatedly. the typical coronavirus remains localised to the epithelium of the upper respiratory tract, causes mild disease and elicits a poor immune response, hence the high rate of reinfection (in contrast to sars-cov and mers-cov, which go deeper into the lungs and hence are relatively less contagious). there is no cross-immunity between hcov- e and hcov-oc , and new strains arise continually by mutation selection. coping strategies and collective strategies how a virus spreads and its disease progresses depend not only on the variables described above (table ) but also on the human reactions deployed when people are confronted with a disease outbreak or the threat of an outbreak. all these variables combined result in what unfolds as 'the epidemic' and the diverse ways it affects communities. what a population experiences during an epidemic is not fully characterised by the numbers of known infections and deaths at the scale of a country. such numbers hide regional and local differences, especially in large and diverse countries. the epidemic reaches the different geographical areas of a country at different moments and with different intensities. it affects different communities in variable ways, influencing how these communities perceive it and react to it. what constitutes a local covid- epidemic is thus also characterised by the perceptions and the reactions it triggers in the different sections of the society. even before the virus reaches a community, the threat of an epidemic already causes fear, stress and anxiety. consequently, the threat or arrival of the epidemic also triggers responses, early or late, with various degrees of intensity and effectiveness. the response to an epidemic can be divided into individual and household actions (coping strategies), and collectively organised strategies (collective strategies). coping strategies are the actions people and families take when disease threatens and sickness occurs, including the ways they try to protect themselves from contagion. collective strategies are voluntary or mandated measures deployed by organised communities and public authorities in response to an epidemic. these include, among others, isolation of the sick or the healthy, implementation of hygiene practices and physical distancing measures. they can also include mobility restrictions such as quarantine and cordon sanitaire. coping strategies and collective strategies also include treatment of the sick, which critically depends on the availability and effectiveness of diagnostic and therapeutic tools, and performance of the health system. collective strategies also include research being deployed to further scientific insight and the development of diagnostic and therapeutic tools, potentially including a vaccine. implementation of these measures depends not only on resources available but also on the understanding and interpretation of the disease by both the scientific community and the community at large, influenced by the information people receive from scientists, public authorities and the media. this information is interpreted within belief systems and influenced by rumours, increasingly so over social media, including waves of fake news, recently labelled 'infodemics'. coping strategies and collective strategies start immediately, while there are still many unknowns and uncertainties. progressively, as the pandemic unfolds and scientists interpret observations in the laboratory, in the clinic, and in society, more insights are gained and inform the response. table lists measures recommended by the who for preventing transmission and slowing down the covid- epidemic. - 'lockdown' first employed in early in wuhan, china, is the label often given to the bundle of containment and mitigation measures promoted or imposed by public authorities, although the specific measures may vary greatly between countries. in china, lockdown was very strictly applied and enforced. it clearly had an impact, resulting in total interruption of transmission locally. this list or catalogue of measures is quite comprehensive; it includes all measures that at first sight seem to reduce transmission opportunities for a respiratory virus. however, knowledge is lacking about the effectiveness of each measure in different contexts. as a global health bmj global health agency, the who recommends a 'generic catalogue' of measures from which all countries can select an appropriate mix at any one time depending on the phase of the epidemic, categorised in four transmission scenarios (no cases, first cases, first clusters, and community transmission). however, under pressure to act and with little time to consider variable options, public authorities often adopted as 'blueprint' with limited consideration for the socioeconomic context. the initial lockdown in china thus much inspired the collective strategies elsewhere. this has been referred to as 'global mimicry', : the response is somehow partly 'copy/paste' from measures observed previously (strong path dependency). some epidemiologists in northern europe (including the uk, sweden and the netherlands ) pleaded against strict containment measures and proposed that building up herd immunity against sars-cov- might be wiser. towards early april , it became increasingly clear that reaching herd immunity in the short term was illusive. most countries thus backed off from the herd immunity approach to combating covid- and implemented lockdowns. the intensity of the lockdowns has been variable, ranging from very strict ('chinese, wuhan style'), over intermediary ('french/italian/new york city style' and 'hong kong style'), to relaxed ('swedish style'), or piecemeal. the effectiveness of lockdowns largely depends on at what stage of the epidemic they are started, and how intensively they are applied. this is quite variable across countries, depending on the understanding and motivation of the population and their perceived risk ('willingness to adhere'), on the trust they have in government advice ('willingness to comply'), and on the degree of enforcement by public authorities. the feasibility for different population groups to follow these measures depends largely on their socioeconomic and living conditions. it is obviously more difficult for people living in crowded shacks in urban slums to practise physical distancing measures and strict hand hygiene when water is scarce than for people living in wealthier parts of a city. collateral effects of the response every intervention against the covid- epidemic has a certain degree of effect and comes at a cost with collateral effects. each collective strategy ( ) has intended and unintended consequences (some are more or less desirable); ( ) is more or less feasible and/or acceptable in a given context and for certain subgroups in that society; ( ) has a cost, not only in financial terms but in many other ways, such as restrictions on movement and behaviour, stress, uncertainty and others. these costs are more or less acceptable, depending on the perception of the risk and many societal factors; ( ) can be implemented with more or less intensity; and ( ) can be enforced more or less vigorously. the balance between benefit and cost is crucial in judging whether measures are appropriate, which is very context specific. furthermore, benefits and costs are also related to the positionality from which they are analysed: benefits for whom and costs borne by whom? more wealthy societies with strong social safety nets can afford increased temporary unemployment. this is much more consequential in poorer countries, where large proportions of the population live precarious lives and where public authorities cannot implement generous mitigation measures at scale. the adherence to hygiene and distancing measures depends not only on living conditions but also on risk perception and cultural norms. mass masking has been readily accepted in some asian countries, where it was already broadly practised even before the covid- bmj global health epidemic. it remains more controversial in western societies, some of which even have legal bans on veiling in public places. lockdowns are unprecedented and have triggered intensive public debate. not surprisingly, the impact of lighter lockdowns on the transmission is much less impressive; they decrease transmission but do not stop it. quite rapidly, the justification for lockdowns shifted from stopping transmission to 'flattening the curve'. also, once a lockdown is started, rationalised, explained and enforced, it is difficult to decide when to stop it. exit scenarios, usually some form of progressive relaxation, are implemented with the knowledge that transmission will be facilitated again. what we already know the available information on sars-cov- and the spectrum of covid- disease is summarised in tables and . it is increasingly becoming clear that most transmission happens indoors and that superspreading events trigger intensive dissemination. the virology and immunology of sars-cov- / covid- are being studied intensively. this is critical not only to understand what will potentially happen in future waves but also for the development of a vaccine. some scientists and companies are very upbeat about the possibility of producing a vaccine in record time. having a vaccine is one thing, but how effective it is, is quite another. as acquired immunity after a natural infection is probably not very robust (table ), it will also be challenging to trigger robust immunity with a vaccine, but perhaps it is not impossible. many questions remain, some of which are summarised in table . regarding the severity of covid- , initial fears of very high mortality have also lessened. it has progressively become clear that many infections remain asymptomatic, that severe disease is rare in children and young adults, and that mortality is heavily concentrated in the very old and those with comorbidities. table summarises a fuller overview of the present state of knowledge regarding covid- . with covid- epidemics unfolding rapidly, several of the variables in the transmission of sars-cov- and the disease spectrum of covid- could be quantified. this allows for mathematical modelling. several models have been quickly developed, leading to predictions of the speed of transmission and the burden of covid- (box ). predictive models developed by the imperial college ; the center for disease dynamics, economics & policy and johns hopkins university ; the institute for health metrics and evaluation ; harvard university ; and the who, including an 'african model', are a few that are influencing containment strategies around the world. although the covid- pandemic triggered unprecedented research efforts globally, with over scientific papers published between january and april , there are still critical unknowns and many uncertainties. tables and summarise many of the knowns, but their relative importance or weight is not clear. for instance, the virus can spread via droplets, hands, aerosols, fomites and possibly through the environment. however, the relative importance of these in various contexts is much less clear. these factors undoubtedly vary between settings, whether in hospitals, in elderly homes, or at mass events. the weight of the variables also probably differs between the seeding and initial spread in a community and the spread when it suddenly amplifies and intensifies. the importance of each variable probably also depends on climatic conditions, not only outdoors, but also on microclimates indoors, influenced by ventilation and air conditioning and built environments. we summarise the critical unknowns in table along some elements to consider in addressing the unknowns and thoughts on their importance. uncertainty remains, leading to controversy and directly influencing the choice of containment measures. controversy continues regarding when and where lockdown or more selective measures are equally effective with lower societal effects. relationship between the dose of the initial infectious inoculum, transmission dynamics and severity of the covid- disease new evidence is being discovered rapidly. some evidence comes from field observations and ecological studies; other evidence results from scientific experiments or observations in the laboratory and the clinic. sense-making by combining insights from different observations and through the lens of various disciplines can lead to hypotheses that can be tested and verified or refuted. one such hypothesis is that there is a relationship between the dose of virus in the infectious inoculum and the severity of covid- disease. several intriguing observations in the current pandemic could be (partially) explained by such a relationship. we develop this hypothesis in box , as an example of possible further research, to create new insight which may influence control strategies. this viral inoculum theory is consistent with many observations from the early stages of the covid- pandemic, but it is not easy to test scientifically. as covid- is a new disease, we should make a distinction between ( ) the current - 'virgin soil pandemic' caused by sars-cov- , specifically in how it will further spread around the globe in the first wave, and ( ) the potential future transmission in subsequent waves. in some countries, transmission will continue at lower levels. in other countries, such as china, the virus bmj global health may have been eliminated but can be reintroduced in identical or mutated form. for the current first wave, using influenza and the common cold as reasonable comparisons, it is possible that the major epidemics, as witnessed in wuhan, northern italy, or new york, will typically occur in temperate climates in the winter season. some predict that such epidemics will last between and weeks (but this is just a plausible and reasonable comparison in analogy with seasonal influenza). it is possible that in hotter climates the transmission may become continuous, year round at lower levels. it is increasingly clear that hot climate does not exclude superspreading events as observed in guayaquil, ecuador and in various cities in brazil. ventilation, air-conditioning and crowded places may still create favourable environments for intensive transmission. it is also quite possible that the more difficult spread of sars-cov- in such climates may, in certain table knowns, uncertainties and unknowns about severe acute respiratory syndrome coronavirus (sars-cov- ), as of may origin of sars-cov- ► most probably from bats via intermediate animal hosts to index case. all subsequent cases resulted from human-to-human transmission. transmission ► mainly through respiratory droplets from infected persons ; by hands, after contamination at nose, mouth or eyes; also through air on exposure to sneezing or coughing from an infected person at close distance. ► through aerosols, while singing/talking loudly in congregations, groups, parties, karaoke, and so on, especially in poorly ventilated spaces. ► through fomites. ► possibly via faecal-oral route ; detection in sewage. [ ] [ ] [ ] ► related to peak in upper respiratory tract viral load prior to symptom onset in presymptomatic (paucisymptomatic) persons. ► transmission dynamics in asymptomatic persons not fully elucidated although viral shedding occurs. influence of climate and/or air pollution on transmission ► influence of climate on the capacity of the virus to survive outside human body (in air, in droplets, on surfaces, etc.) and to spread has been speculative. ► may spread more readily in milder/colder climate ; although variability of the reproductive number could not be explained by temperature or humidity. ► existing levels of air pollution may play a role; air pollutants, such as particulate matter, nitrogen dioxide and carbon monoxide, are likely a factor facilitating longevity of virus particles. ► elevated exposure to common particulate matter can alter host immunity to respiratory viral infections. immunity-protective antibodies ► igm and iga antibody response - days after onset of symptoms, does not depend on clinical severity, correlates with virus neutralisation; igg is observed ~ days after onset of symptoms, may or may not correspond to protective immunity. whether antibody response is long lasting has remained unclear. ► rechallenge in rhesus macaques showed immunity post primary infection. how protective immunity after first infection is against subsequent infection with an identical or mutated strain has been uncertain. ► incidental reports showed recovered persons positive by real-time pcr, later attributed to testing errors. seroprevalence to sars-cov- ► reported estimates for seroprevalence range between . % and . % ; differences in timing of the serosurvey, the use of assay kits with varying sensitivity/specificity, and different methods for detection may contribute to this large variation. ► seemingly high seroprevalence may be due to cross-reactive epitopes between sars-cov- and other hcovs. ► whether seroprevalence implies immune protection is unclear, yet, some countries have considered use of 'immunity passports'. ► for herd immunity to be effectively achieved, an estimated seroprevalence of % of the population will be required. other studies estimate between . % and % seroprevalence in different countries. communities, be compensated for by human factors such as higher population density, closer human contacts and lesser hygiene (as, for instance, exist in urban slums in mega cities in low income countries). how all this plays out in sub-saharan africa, in its slums and remote areas, is still largely unknown. with sars-cov- , transmission scenarios are mainly based on mathematical models despite their serious limitations (box ). as the virus continues to circulate, it will progressively be less of a 'new disease' during subsequent waves. the immunity caused by the first epidemic will influence how the virus spreads and causes disease. whether later waves will become progressively milder or worse, as observed in the - spanish influenza, is a matter of intense speculation. both views seem plausible and the two are not necessarily mutually exclusive. indeed, immunity should be defined on two levels: individual immunity and herd immunity. individual immunity will dictate how mild or severe the disease will be in subsequent infections. herd immunity could be defined in different communities/regions/ disease spectrum ► many different estimates: ► initially, it was estimated that among infected, % remained asymptomatic, %- % had mild/moderate disease, %- % had severe disease, and %- % became critically ill. - ► very variable estimates for remaining totally asymptomatic (estimated %- % [ ] [ ] [ ] [ ] ). ► what determines that an infection remains asymptomatic? ► quasi-absence of disease in children: why? case fatality rate (cfr) ► initial estimates cfr: %- %; comparisons: influenza . %; common cold: %; sars: %- %; mers: %. ► calculated infection fatality rates (cifr) and calculated cfr (ccfr) on the princess diamond were . % and . %, respectively (for all ages combined), and projected cifr and ccfr for china were between . %- . % and . %- . %, respectively. in gangelt, germany: ccfr of . %. ► cfr is influenced significantly by age; male sex; comorbidities; body mass index and/or fitness; and adequacy of supportive treatment, mainly oxygen therapy. if a vaccine is developed? ► what type of vaccine will it be (live/non-live, classic killed, dna, or recombinant)? ► will it need special manufacture and transport conditions (such as cold chain)? ► how robust will be vaccine-acquired immunity? after how many doses? ► how protective will it be against infection? ► for how long will vaccine-acquired immunity last? and hence: how often will the vaccine have to be administered? only once? or yearly? ► will there be any adverse effects? acquired immunity is not very strong; hence, what is the consequence regarding herd immunity? ► to achieve herd immunity, how efficient will the vaccine need to be? ► what proportion of the population (critical population) will need to be vaccinated? ► how long will it take to effectively vaccinate the critical population? ► will vaccination be acceptable in the population? or will vaccine hesitancy reduce uptake? what are the socioeconomic implications? ► which countries will get the vaccine first (implications for lics/lmics)? ► how expensive will the vaccine be? ► will vaccination be made mandatory, especially for international travel? the various degrees of societal disruption and the collateral effects on other essential health services (eg, reluctance to use health services for other health problems, because of 'corona fear'). our growing knowledge may enable us to progressively improve our response. learning from the variety of ways the covid- epidemic is unfolding across the globe provides important 'ecological evidence' and creates insights into its epidemiology and impacts. until now, the insights gained on covid- have been largely dominated by the covid- epidemics in the global north. more understanding of lived experiences of people in a variety of contexts, where the epidemic is spreading more slowly and with different impacts, is necessary to get a full global picture and allow learning from this variety. this is an important missing piece of the covid- puzzle. bmj global health and emerging voices for global health have launched a call (https:// blogs. bmj. com/ bmjgh/ / / / from-models-to-narratives-andback-a-call-for-on-the-ground-analyses-of-covid- spread-and-response-in-africa/) for such on-the-ground narratives and analyses of the spread of and response to covid- , local narratives and analyses that will hopefully help to further enrich our understanding of how and why the covid- pandemic continues to unfold in multiple local epidemics along diverse trajectories around the globe. table some critical unknowns in sars-cov- transmission which transmission patterns will occur and will human-to-human transmission continue permanently? ► seasonal transmission in temperate climate? ► continuous tides, with ups and downs? ► the experience from china and some other countries showed that 'local elimination' is possible but risk of reintroduction remains. ► increasingly unlikely that elimination everywhere is possible. this will strongly depend on: how strong will the acquired immunity after a first infection with sars-cov- be and how long will it last? ► evidence of acquired immunity against subsequent infections has been limited. ► measurable antibodies have been observed in most persons who have recovered from covid- , and research in animal models has suggested limited possibility of reinfection. ► it is still unclear as to how robust the immunity is and how long it will last. ► debate on use, practicality and ethics of 'immunity passports' for those recovered from covid- has been ongoing. how stable is the virus (mutation) and do the different clades seen worldwide have any effect on the transmission potential/severity of the disease? ► if the virus mutates quickly and different strains develop, then antibodydependent enhancement might be an important risk, as in dengue with its four different strains. if so, then in subsequent waves progressively more severe cases could occur. ► this has been reported for the spanish influenza, where the second and third waves were characterised by a more severe disease pattern. what is the role of children in transmission? ► children have quasi-universally presented less severe disease. however, their susceptibility to infection remains unclear, with large heterogeneity reported between studies. ► their role in transmission has remained unclear, but evidence points to a more modest role in transmission than adults. how significant are asymptomatic carriers in transmission? ► there have been several reports of asymptomatic transmission and estimates based on modelling. ► increasing consensus that asymptomatic carriers play an important role in transmission. box relationship between the dose of the initial infectious inoculum, transmission dynamics and severity of the covid- disease hypothesis: the dose of the virus in the initial inoculum may be a missing link between the variation observed in the transmission dynamics and the spectrum of the covid- disease. it is plausible that: ► viral dose in inoculum is related to severity of disease. ► severity of disease is related to viral shedding and transmission potential. this hypothesis plays out potentially at three levels: ► at individual level: a person infected with a small dose of viral inoculum will on average develop milder disease than a person infected with a high viral inoculum and vice versa. ► at cluster level: a person with asymptomatic infection or mild disease will on average spread lower doses of virus in droplets and aerosols and is less likely to transmit disease; when the person transmits, the newly infected person is more likely to have milder disease than if infected by a severely ill person, who spreads on an average higher doses of virus. this causes clusters and chains of milder cases or of more severe cases. ► at community level: in certain contexts, such as dense urban centres in moderate climates during the season when people live mostly indoors, the potential for intensive transmission and explosive outbreaks is high, especially during indoor superspreading events. in other contexts, such as in rural areas or in regions with hot and humid climate where people live mostly outdoors, intensive transmission and explosive outbreaks are less likely. outbreak of pneumonia of unknown etiology in wuhan, china: the mystery and the miracle new-type coronavirus causes pneumonia in wuhan: expert a novel coronavirus from patients with pneumonia in china coronaviridae study group of the international committee on taxonomy of viruses. the species severe acute respiratory syndrome-related coronavirus: classifying -ncov and 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isn't mutating quickly, suggesting a vaccine would offer lasting protection. the washington post genomic epidemiology of novel coronavirus implications of test characteristics and population seroprevalence on 'immune passport' strategies systematic review of covid- in children shows milder cases and a better prognosis than adults susceptibility to and transmission of covid- amongst children and adolescents compared with adults: a systematic review and meta-analysis presumed asymptomatic carrier transmission of covid- transmission of -ncov infection from an asymptomatic contact in germany acknowledgements we would like to thank johan leeuwenburg, piet kager, and luc bonneux for useful comments on a previous draft, the teams of the riposte corona, inrb, kinshasa and the belgian embassy in kinshasa for welcoming and hosting wvd during his unscheduled extended stay in kinshasa during the lockdown, march-june . we are thankful to mrs. ann byers for editing the manuscript at short notice. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.competing interests none declared. provenance and peer review not commissioned; externally peer reviewed. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. key: cord- -tcied l authors: ojeahere, margaret isioma; de filippis, renato; ransing, ramdas; karaliuniene, ruta; ullah, irfan; bytyçi, drita gashi; abbass, zargham; kilic, ozge; nahidi, mahsa; hayatudeen, nafisatu; nagendrappa, sachin; shoib, sheikh; jatchavala, chonnakarn; larnaout, amine; maiti, tanay; ogunnubi, oluseun peter; el hayek, samer; bizri, maya; schuh teixeira, andre luiz; pereira-sanchez, victor; da costa, mariana pinto title: management of psychiatric conditions and delirium during the covid- pandemic across continents: the lessons thus far date: - - journal: brain behav immun health doi: . /j.bbih. . sha: doc_id: cord_uid: tcied l background: with the uncertainties of covid- , people infected by coronavirus present with diverse psychiatric presentations. some centers have had to manage their patients with existing protocols, others have had to come up with innovations. we aim to report the challenges and good practices recorded in the management of psychiatric conditions and delirium coexisting with covid- and during the covid- era across continents. material and methods: early career psychiatrists (ecps) from across five continents were approached to provide their perspective on the management of psychiatric conditions in patients with covid- and during the current pandemic. results: we collected information about the experiences from ten countries. commonalities were similar psychiatric presentations and poor preparedness across countries. differences were varying innovations and adjustments made in the management of psychiatric conditions coexisting with covid- . good practices which can be adopted by other countries are novel approaches such as telepsychiatry, proactive consultation-liaison units and enhanced community services targeted at circumventing challenges faced yet providing mental health services. conclusions: this publication highlights the need for global preparedness in the mental health sector during outbreaks of infectious diseases. with our results we can conclude that there is the need for concerted efforts targeted at global and locally sensitive adaptation of existing protocols and the development of new guidelines for the management of psychiatric conditions for the present pandemic and subsequent occurrences. informed of some cases of pneumonia in the city of wuhan, hubei region (zhu et al., ) . the disease was subsequently associated with a potentially deadly novel coronavirus, also known as sars- -ncov, which causes coronavirus disease (covid- ) and its rapid spread around the world led to the declaration of covid- as pandemic on march , (chew et al., elbay et al., ) . the reported symptoms of covid- are primarily respiratory with acute respiratory distress syndrome ultimately leading to dead in the most severe cases (fu et al., ) . however sars-cov- , both for its neurotropism (troyer et al., ) , and for the social consequences secondary to social distancing and the increasingly intense general lockdowns, can determine the aggravation or new onset of psychiatric disorders (asadi-pooya and simani, ; filatov et al., ; nath, ; vindegaard and benros, ) . psychiatric symptoms may include posttraumatic stress disorder (ptsd), delirium, anxiety and depression among patients infected . also, psychiatric symptoms of ptsd, burnout, depression and anxiety have been described among health care workers during the pandemic (tsamakis et al., ; walton et al., ) . the elusive nature of the sars-cov- virus, its infectivity rate, and its mode of transmission have boosted its continuous spread. initial studies described it as a respiratory disease majorly affecting the lungs; however, more recent findings have pointed to covid- as a multisystemic disease. the brain has also been reported as affected by the virus, directly and indirectly . early in the pandemic, physicians around the world were overwhelmed, and in some countries psychiatrists were redeployed to critical care units with focus on the management of j o u r n a l p r e -p r o o f respiratory-related conditions. however, increasing research shows that beyond physical conditions, covid- is fraught with neuropsychiatric problems. this includes reported causes of delirium (k in patients infected with the sars-cov- virus and the acute exacerbation of pre-existing mental health conditions (xiang et al., ) . a considerable number of patients with comorbid covid- and psychiatric illnesses have been managed in isolation centers or specialized care units usually involving multidisciplinary teams. some of these teams and facilities were ill-equipped to manage the acute phases of psychiatric complications of covid- and the increasing cases of pre-existing psychiatric conditions. the early career psychiatrists (ecps) section is a formal arm of the world psychiatric association (wpa) which represents and supports psychiatric trainees and early career psychiatrists (up to seven years after completion of their training in psychiatry regardless of age) (pinto da . one of the objectives of this section of the wpa is the professional development of early career psychiatrists through intersectional collaborations (herrman, ; schulze, ) , thereby encouraging cross-cultural collaborations and international research projects. amid the advent of the covid- pandemic, ecp members who had established relationships from previous conferences, courses and training programs were contacted via whatsapp and a group created through networking to brainstorm on covid- related research topics and possible interventions. group discussions were held via online messaging and conferencing platforms such as emails, whatsapp and zoom. in the present study, twenty one early career psychiatrists ( females and males) from thirteen countries, comprising at least one from five of the seven continents (africa, asia, europe, north j o u r n a l p r e -p r o o f america and south america) were approached without coercion by the lead (mio) and co-lead (rdf) authors via whatsapp and emails to share insights and experiences about the challenges and good practices faced in the management of delirium and other psychiatric conditions manifesting in patients with covid- and during the covid- era. this stage involved the evaluation of ongoing preventative and therapeutic approaches which revolved around the management of psychiatric conditions and delirium amid the covid- era. the contributors in the study were requested by the lead and co-lead authors to share information from their country on these approaches such as: an overview of new and exacerbation of preexisting cases of psychiatric conditions, existing and new infrastructures and resources, treatment utilized (pharmacologic and non-pharmacologic), new innovations and modifications of existing protocols which can be adopted for future implementation. the lead author and co-lead led the group discussion and manuscript drafting. a compilation of the contributions submitted by all the co-authors was reviewed and comprehensive appraisal of existing literature was applied. the literature review focused on identifying relevant existing information related to epidemiology, suggestions, interventions, and recommendations. this information formed the basis of a revised manuscript which was shared to a sub-set of the group (the senior investigator and some co-authors previously identified and informed to review the manuscript) for further appraisal before sharing to all co-authors. j o u r n a l p r e -p r o o f the revised manuscript was shared with all co-authors for comments, suggestions, and alterations. thereafter, it was repeatedly adjusted based on consensus and comments. the modified delphi method (i.e. consensus decision making (> % representative agreeable) was adopted for final inclusion. the present study did not engage the direct involvement of human participants or utilization of identifiable data, hence, ethical approval from local institutional ethical committees was not necessary. in this publication we summarize the country specific insights provided by the contributors and present an integrated, global perspective of the lessons we have learned on this topic, with the hope that it is informative for other colleagues worldwide. the reality of eleven countries has been described by early career psychiatrists, who have been conducting research on the impact of codiv- with the support of the early career psychiatrists section of the world psychiatric association. in germany, exacerbation of mental health disorders during covid- pandemic has been reported. particularly alcohol and drug abuse, leading to domestic violence, anxiety problems j o u r n a l p r e -p r o o f among mentally ill patients as well as the presence of hallucinations were reported (fatke et al., ) . also, cases of 'cyberchondria' (i.e., disproportionate concerns about one's health as a result of reading contents related to health online), difficulties with emotional regulation resulting from personal crises (i.e., job loss, illness, death of loved ones) were observed in the general population. likewise, a positive correlation between cyberchondria and widespread anxiety occurring during periods of virus outbreaks was observed (jungmann and witthöft, ) . the restrictive rules of quarantine made it difficult for many patients to get proper outpatient mental health care. the limited access to appointments with psychologists, psychiatrists, and other professionals, as well as the need for a transition to virtual psychotherapy were serious challenges for many patients. it was particularly worrying for many senior citizens due to their limited digital literacy. further worsened by the inability of family members to assists, as the laid down recommendations prevented them from visiting their elderly ones during the quarantine imposed restrictions was one of the main issues among mental health sector faced during the present pandemic in germany (thome et al., ) . the cases of anxiety among mentally ill patients suspected to have been infected with the virus while on hospital admission were observed. the isolation of suspected covid- cases as well as the transfers to internal units were serious challenges for the residents of psychiatric hospitals. liaison psychiatry faced a new challenge with the treatment of infected psychiatric patients in intensive care units. this supports evidence that the occurrence of acute psychiatric conditions requires an accurate multidisciplinary approach during pandemics (mukherjee et al., ) . pandemic. during the lockdown, private psychiatric outpatient departments and inpatient services were closed, except for emergency services. the outpatient departments (opd) in the government hospital were also affected in terms of a smaller number of patients visiting hospitals (mukherjee et al., ) . in india, though the government has taken proactive measures towards the psychological distress among the public, the preparation and planning in the mental health sector for the pandemic was lacking. in addition, india has a huge shortage of mental health professionals, which could affect the delivery of mental health services and may widen the treatment gap for mental disorders (r. s. . the indian government announced a countrywide lockdown on th march for weeks initially and later for another and half weeks to slow down the transmission of covid- disease (pulla, ) . however, the indian psychiatric society (ips) considered the impact on the psychological and emotional health and released a position statement on march , . the statement recognized community's needs during this pandemic, promoting the transfer of the center of care from the clinics to the communities, and advocated for the use of available information technology to 'reach the unreached' via online consultation with psychiatrists. due to sudden non-availability of alcohol or opioid distribution, the abrupt rise in patients with sud (mainly alcohol) related disorders (e.g. withdrawal) was observed. there has been an increase in suicide due to covid- (shoib et al., ) . considering the potentials of increased relapse of illness when psychotropic medications are not available to patients due to the inability to renew their prescriptions, the ips asked that norms be relaxed so that patients can get their refills with an old prescription or through tables and . presently in iran, psychiatric patients have access to teleconsultation through / hotline numbers. also, they can access online psychological interventions regularly and do not need to visit their therapists in person in the era of the covid- pandemic. in addition, electronic prescription services have been recently developed in the health care system of iran. for individuals with mild forms of mental health problems such as mild anxiety, depression, and dementia, activities such as meditation, group physical practice, relaxation, and social interactions using social media applications, and video-call technology may improve the mental and physical health and prevent loneliness (padala et al., ) . however, some patients have a number of j o u r n a l p r e -p r o o f limitations in using these technologies, such as fear and lack of familiarity. besides, hearing and vision impairment or loss may reduce the effectiveness of these methods. with the covid- emergency, the kosovo ministry of health and associated medical bodies multidisciplinary mental health teams established by health authorities at regional and national levels (including psychiatrists, psychiatric nurses, clinical psychologists, psychosocial counsellors j o u r n a l p r e -p r o o f and other mental health workers) provided mental health support for patients, with existing protocols. psychiatrists may be asked to consult patients receiving pharmacotherapy for covid- and should therefore be familiar with some of the medications currently being used and psychiatric side effects such as mood and anxiety disturbances, insomnia, and more rarely, psychosis. patients should be asked about any other prescribed medications or supplements they may be taking in the belief it may reduce their susceptibility to covid- infection. currently, there are no guidelines for the treatment of covid- related psychiatric conditions. national institute public health of kosovo published a manual for covid- prevention and control with recommendations for minimizing covid- spread, making recommendations on mitigation steps to reduce community transmission of covid- , such as restricting visitors, adjusting standards of care, changing elective procedures, and establishing cohort units, among others (kosovës, n.d.) . however, no specific therapeutic protocol for covid- exists in kosovo, valid international guidelines are needed to improve the delivery of mental health services as it is imperative that these services must be provided during the covid- pandemic. the first reported case of covid- in lebanon was in february , a month before it was declared a pandemic by the who. these are unprecedented times for the health system but more so for the psychiatric provider. the health system in lebanon is one of the few in the middle east that does not have a mental health policy addressing issues like the poorly financed mental health services despite its tremendous burden of mental illnesses in the country (kudva et al., ; . with the covid- pandemic, mental health was treated as priority (khoury et al., ) and a national mental health program was initiated in lebanon. however, some centers relocated their psychiatric inpatient unit to smaller units (with limited bed spaces) in the main hospital to create space for the pandemic evaluation clinic and centre. with the pandemic, bed spaces for psychiatric cases became scarcer and almost unavailable for acute cases requiring seclusion. some other psychiatric hospitals stopped accepting new cases. previous reports from china had mentioned the risk of infection on psychiatric wards and how an outbreak which affected staff and patients was contained with strict confinement (zhu et al., ) . taking into cognizance the existing overcrowded psychiatric wards, a cause of concern for most psychiatrists in lebanon was managing the comorbidity of covid- infection in severe mentally ill patients. common mental disorders cases treated have been stress-related conditions, anxiety, mood disorders, and insomnia. in parallel, a rapid tele-deployment was instituted in emergency settings likewise, the launch of telepsychiatry consultations to our patients over several months. of the many hurdles that came with transiting to a digital platform, one has been getting patients to fill their prescriptions as the system in lebanon does not have a unified electronic health care record. in view of the possibility of a high risk of relapse due to multiple stressors in patients with preexisting psychiatric conditions, a proactive consultation-liaison model, rather than a reactive one whereby all patients presenting for testing or admission to the covid- unit were screened for depression and anxiety and offered free services. this model can be replicated in times of future crises. one of the challenges faced was managing admitted covid- patients. however, the bulk of our consults were done via phone conversations with patients and staff, as the provision of other electronic gadgets needed to implement more advanced forms of telepsychiatry were not approved. alternatively, our experience of delirium mirrors that reported globally (beach et al., ; meagher et al., ) . another challenge faced is the resistance from medical teams in j o u r n a l p r e -p r o o f initiating antipsychotics for agitated delirium. lebanon has included hydroxychloroquine as part of the regimen used for covid- patients in the icu. however, more research may be required to evaluate the success of this regimen. cases of delirium have not been observed as a common manifestation of patients infected with in line with the lockdown policy during the state of emergency, many general hospitals have had to cancel several "non-urgent" patients' appointments, of which most psychiatric outpatients were categorized ("state of emergency extended," n.d.). most of the psychiatric conditions which presented at the thai hospitals at the peak of pandemic were emergency cases such as acute mania and severe psychosis usually precipitated by the abstinence from psychotropic medications, other common cases were anxiety, depression, and insomnia (jatchavala, ) . the thai village health volunteers have played important roles, not only for covid- patients but in providing healthcare generally. one of the volunteers' responsibilities include delivering psychotropic drugs j o u r n a l p r e -p r o o f and relapse surveillance for psychiatric patients within some specified areas ("thailand's one million health volunteers hailed as coronavirus heroes : thai health promotion foundation -the sustainabillty of well-being for thai people," n.d.). according to records, delirium was not commonly seen among covid- infected patients in thailand, however, there are no nationwide systematic data collection of delirium. contrarily, thai currently battles cases of delirium tremens following alcohol withdrawal for at least three months from july, in line with the thai buddhist lent, which requires an "alcohol-free" state (saengow, ) . thailand and there is a need for more research to guide preparations for action plans for subsequent occurrences. tunisia is one of the countries least affected by the covid- pandemic. the first covid- case was detected march , , and as at july , , there were cases and deaths. the mental health sector was barely affected by the pandemic as no psychiatric complication of covid- was reported and no patient with covid- was hospitalized in psychiatric units either. general preventive measures are imposed in all mental health care facilities. patients as well as doctors were obliged to wear at least surgical flaps during interviews and in the hospital. telepsychiatry platforms were implemented to minimize the number of hospital visits. a protocol was established to serve as a guide on patients with covid- who will require consultation or will be hospitalized. patients suspected to have covid- were hospitalized in a separate ward (specially designed for them) where all necessary ppes were made available for the medical staff. a toll-free hotline was also established by the ministry of health in order to respond to the concerns of people in relation to widespread anxiety and to prevent development of more serious psychiatric conditions like ptsd. as there are no psychiatric patients with covid- yet, no specific therapeutic protocol has been established. the turkish ministry of health and associated medical bodies have developed documents on the mitigation, management and treatment of covid- infection ("yeni koronavirüs hastalığı ," n.d.). however, there seems to be an absence of official guidelines on the management of neuropsychiatric symptoms or delirium in patients with covid- . task forces of the psychiatric association of turkey (pat) have developed several guidance documents for mental health professionals and individuals to manage their previous existing psychiatric disorders (european psychiatric association, n.d.) . according to the recommendations developed by pat on delirium and covid- factors to take into cognizance when managing cases of delirium cooccurring with covid- include: ) respiratory problems, especially the presence of hypoxia; ) fever; ) metabolic disorders; ) nutritional disorders and dehydration; ) side effects/interactions of drugs. likewise, the treatment of the underlying medical or surgical problem is important in the management of delirium. antipsychotic drug use has been considered for symptomatic control, especially agitation. lopinavir/ritonavir, because of their strong cyp a inhibition, are not recommended to be used along with quetiapine, as it poses serious risk of toxicity. it should be noted that since they inhibit cyp d , ritonavir and hydroxychloroquine should be used cautiously, as they may increase the risk of qt prolongation when used along with haloperidol. in the management of delirium, typical and atypical antipsychotics are recommended. the table ). as the number of cases in the united states continues to rise exponentially daily, the magnitude of covid- as a public health emergency becomes more profound. affecting the health, safety, and well-being of both individuals (leading to emotional isolation, etc.) and communities (owing to job loss and furloughs, school closures, limited resources for medical response, etc.), these effects can have a significant impact on individuals' mental health leading to relapses on substance use, depression, and medication non-compliance. as the united states continues to learn to cope with this pandemic, interventions that have been learned in previous pandemics of sars, mers, and ebola are implemented. pfa is an early intervention that targets affected survivors during this outbreak. several pfa frameworks and models are currently being used including john hopkins's pfa tool . the use of lai was continued in some centers for patients with schizophrenia who were stabilized on lai. outpatients were screened for covid- prior to administration of the lai, thereafter telepsychiatry was instituted for further care. in some centers, to reduce the risk of transmission and conserve ppes, many patients with schizophrenia who responded well with lai were not given their monthly injection as it was j o u r n a l p r e -p r o o f considered an elective procedure ("coronavirus disease (covid- ) : psychiatric illness -uptodate," n.d.). however, apa reiterated the importance of lai and considered it an essential procedure as it can lead to significant decompensation of their psychiatric illnesses. daily home visits are currently being considered as a reasonable alternative to inpatient hospitalization for patients with mild to moderate symptoms ("coronavirus disease (covid- ) : psychiatric illness -uptodate," n.d.). patients who require inpatient hospitalization are being screened for covid- with nasopharyngeal swab before being admitted to inpatient units. electroconvulsive therapy is being performed by a minimum number of clinicians required (including treating psychiatrists, anesthesiologist, and a nurse). interventions for managing suicidal ideations and behaviors include telehealth or in-person visits depending on the situation. the management of delirium of covid- in the usa continues to consume hospital resources and prevention strategies for delirium may become an unintended casualty of uncommon resource and personnel apportionment (lahue et al., ) . delirium could present as an early symptom of infection in septic patients. therefore, early and regular screening of delirium using validated screening tools such as cam-icu or icdsc are recommended. however, this may not always be feasible as routine practice of delirium monitoring poses a huge burden on the managing personnel (marra et al., ) . approximately % of covid- patients whose condition required admission to the intensive care unit (icu) needed mechanical ventilation (katarzyna . in the past, delirium rates within mechanically ventilated icu patients were around - % (katarzyna . in light of this pandemic, we may be able to reduce it via lighter sedation and mobilization using the implementation of the safety bundle called the abcdefs endorsed by society of critical care medicine (sccm). several modifications have been made to the current abcdef delirium management guidelines as suggested by several authors and some of them include the following (devlin et al., ; lahue et al., ) : assessment/treatment of pain-better coordination between rns and other clinicians in the use of non-verbal pain assessments for bedside care, the use of behavioral pain assessment tools (behavioral pain score, cpot), the treatment of pain presumptively even when it appears to be absent, regular pain assessment in the prone position and provision of adequate pain management . both spontaneous awakening trials (sat) and spontaneous breathing trials (sbt) regularly assess patients these trials (lahue et al., ) . daily sbt safety screen regardless of perceived sbt success, engaging the assistance of other clinicians to provide bedside care to bedside assessments in the absence of the rn. choices of sedation-several strategizes to optimize analgesic, sedative, and nmb use and decrease safety concerns are being introduced. such as adjusting sedation to ventilation needs, discontinue potent sedative or use agents that don't suppress respiration such as antipsychotics and alpha- agonists (katarzyna . delirium-provide regular delirium screening (cam-icu, icdsc), usual nonpharmacological interventions: such as orientation is a priority because patients are seeing their providers in personal protective equipment; support for senses (hearing aids/glasses); monitor taste/smell; limit use of cns-active medications to agitated patients. early mobility-one major problem faced by critically ill patients with covid- is the reduced time nurses are at the patient's bedside have to perform in-bed rehabilitation efforts as physical and occupational therapists may not be present in the icu. this can be addressed using virtual consultations such as passive physiotherapy interventions, mask extubated icu patients to facilitate hallway walking. family presence-orientate both patients and family regularly, provide phone conversations and video conferences, and tele-medicine tools; provide visual and vocal contact with the j o u r n a l p r e -p r o o f family/caregivers/friends, especially for all dying patients despite isolation, lack of time, and heavy workload (devlin et al., ; k kotfis et al., ; katarzyna kotfis et al., ; lahue et al., ) . one of the many lessons learned is that the practice of psychiatry is changing, and new innovations must be embraced to enable service delivery to the populations they serve (table and ). hence, the use of telepsychiatry and electronic prescriptions becomes a vital tool to be implemented globally. in assessing patients in an era where physical distancing is advocated, there is a need to inquire about covid- related stressors (e.g. exposure to infection, infected family members, and social isolation), other challenges (such as job loss), and psychosocial effects (e.g. depression, psychosomatic preoccupations, anxiety, increased substance use, domestic violence, and physical abuse in children and elderly) (zoremba, ). this will serve as a guide to intervention required, some patients may need full psychiatric evaluation and treatment (in cases of substance withdrawal, in-person consultations are better for patients' and medical teams' anxieties), others would benefit from supportive interventions (such as coping techniques, psychoeducation), whereas, some may only need information and reassurance (table ) . another lesson learned is the need for proactive consultation-liaison teams and the importance of the "liaison" in our "consultation-liaison" units. we, therefore, recommend the continuous need to educate other team members on the basics of delirium and its management. psychiatrists and covid- teams should become familiar with drug-drug interactions and side effect profiles of psychotropics and medications used in covid- treatment. it may therefore be necessary at j o u r n a l p r e -p r o o f national and institutional levels to design and designate some rooms on the general hospital wards for patients with acute mental illness presentations co-existing with other medical conditions. prompt and appropriate mental health care should be available to covid- patients with comorbid mental disorders. safe services should be set up to provide psychological counselling using electronic devices and applications, such as smartphone applications for the affected patients and their families to decrease isolation. one other lesson, particularly for low-and middle-income countries is the need to enable community-based mental health services. the role of community health workers and trained volunteers is pivotal in reducing the existing mental health gap as they can help to institute care and promote activities in the communities geared at preventing relapse in patients. finally, the mental health sector should use the lessons from this pandemic to develop protocols and guidelines for the management of psychiatric conditions in periods of infectious disease outbreaks to increase their level of preparedness globally (table ) . this commentary highlights ecps' experiences and lessons learned across countries in five continents' in the management of delirium and other psychiatric conditions in the context of covid- pandemic. it demonstrates the apparent lack of preparedness for a disease of such magnitude and its impact on psychiatric conditions across countries in the present study. noteworthy were the adjustments that have been made to existing models of mental health care delivery in view of the present pandemic. it is therefore hoped that these lessons will inform strategies for the adaptation of existing protocols and development of new guidelines for the j o u r n a l p r e -p r o o f management of psychiatric conditions targeted at improving mental health care particularly with the emergence and re-emergence of infectious diseases. j o u r n a l p r e -p r o o f table . prophylaxis of delirium (zoremba, ). patient should use their personal belongings -such as their own hearing aids and glasses, any unnecessary change should be avoided as much as possible, such as room changes or changes in therapy time. current newspapers, clearly visible clocks and calendars should be available in patients' rooms. it is of extreme importance for the dementia patients, to establish a strong sense of connection thus ensuring the feeling of security. encouraging to the extent possible, patient's interaction with their loved ones (with a familiar caregiver and/or telecommunication promotes their wellbeing. healthcare professionals should encourage these efforts in patients who are capable. many patients would also benefit from having pictures of their loved ones readily on sight. reduction of negative stimuli (e.g. unnecessary noise, extreme temperatures) and managing underlying health conditions (e.g. acute infections, risk factors). table shows four dimensions of measures for the prophylaxis of delirium in hospitalized patients with covid- , especially for those in the intensive care unit (icu) oral haloperidol: start - mg is started and plan dose increase older patients: start . - . mg and plan increasing the dose parenteral haloperidol: mild agitation: mg medium agitation: mg heavy agitation: mg elderly patient: . mg ***fast and bolus iv administrations can cause fatal cardiac problems. monitoring of vital functions is recommended. the recommended doses are: quetiapine . - mg, olanzapine . - mg and risperidone . - mg dexmedetodimine (for icu patients) ) . ug/kg/h tiapride: hyperkinetic delirium lopinavir/ritonavir: - mg in h promazine antipsychotics: one are of challenge in the use and prescription of antipsychotics is the variety of potential adverse effect. they may increase the risk of cerebrovascular incidents especially in patients with pre-existing cognitive impairments such as dementia, likewise the extrapyramidal and anticholinergic effects (rao et al., ) . comparing second generation antipsychotics, anticholinergic effects are more prevalent with olanzapine (gardner, ) . in covid- patients, the risk of cardiac effects is of concern when antipsychotics are used in combination with antivirals or azithromycin. olanzapine has favorable profile in comparison to other antipsychotics like risperidone, haloperidol and quetiapine, when prescribing with antiviral or already on antiviral. on the other hand, haloperidol can be used in intravenous dose lower than mg as it have rare cardiac effect unless there is risk for qt prolongation (meyer-massetti et al., ) . for the management of agitation due to potential sensitivity to eps (extrapyramidal side effect), low potency antipsychotic like olanzapine, quetiapine and chlorpromazine may be preferred. haloperidol should be used cautiously due to risk of extrapyramidal effects, and qt prolongation in patient on azithromycin or hydroxychloroquine for covid- management. iv and im forms of chlorpromazine may also be particularly effective in patients exhibiting withdrawal who stop taking pills by mouth (beach et al., ) . benzodiazepines: they have the potential of causing respiratory depression and should be avoided in delirium patients infected with covid- (lahue et al., ) . they can be used in those who had seizures withdrawal symptoms, patients who cannot tolerate antipsychotics or where their use is discouraged or contraindicated (e.g. parkinson's disease or lewy body dementia). benzodiazepine withdrawal-induced delirium can occur, so patients who were recently on benzodiazepines should be kept on low doses. benzodiazepines may increase risk for delirium in critically ill covid- patients, so alternative to benzodiazepine for sedation should be used in covid- patient (khawam et al., ) . clonidine, an alpha- agonist can be used for agitation in covid- patient in icu because of easy use and minimal side effect (beach et al., ) . table describes some medications used in our centers and the challenges of their side effect/ drug interactions table . similarities and differences across countries similarities across countries differences imposition of lockdown measures across the countries, especially in the early days of the lockdown some countries suspended community mental health care in the early phase of the pandemic (i.e. nigeria) resultant limited access to mental health care services, except emergencies few countries have the additional burden of shortage of mental health professional (i.e., india and nigeria) increase in new cases and exacerbations of preexisting psychiatric conditions senior citizens were recognized as a high-risk group for delirium delirium was not reported as a common finding across most countries in this study (i.e. germany, india, kosovo, lebanon, nigeria, thailand, and tunisia) across countries, there were varying degrees of lack of preparedness in the mental health sector for infectious diseases. few countries (iran, usa, turkey and thailand) have developed some guidelines and protocols for the management of psychiatric conditions in periods of infectious disease outbreaks adjustments were made to the existing management of delirium and other psychiatric conditions (i.e., pharmacologic and nonpharmacologic measures) variance in the existing management for patients with delirium with covid- infection new challenges for consultation/liaison teams were identified in the care of patients with comorbidities all countries implemented forms of teleconsultation services multidisciplinary approaches were identified table shows the similarities and differences in the management of delirium in patients with covid- and other psychiatric condition during the present pandemic across countries table recommendations the practice of psychiatry is dynamic, therefore novel innovations were actuated and implemented to enhance service delivery. the implementation of telepsychiatry and enabling mechanisms which will ensure its seamless utilization globally. the need for proactive consultation-liaison teams and the importance of the "liaison" component in "consultation-liaison" units. the constant need to educate other nonpsychiatrist practitioners on the management of delirium and other psychiatric conditions co-existing with covid- and other medical or surgical conditions. to the extent possible, earmark wards for patients with acute mental illness presentations co-existing with other medical conditions. especially in the low-and-middle-income countries (lmic), community health workers and trained volunteers are pivotal in reducing the existing treatment gap even in periods of infectious disease outbreaks. the promotion and empowerment of community-based mental health services. improved trainings of community health workers and trained volunteers through linkage, enhancement or mixed models. the management of psychiatric conditions coexisting with and occurring during infectious disease outbreaks may become a common occurrence. consequently, countries should demonstrate increasing levels of preparedness for the present and subsequent outbreaks. there is a dire need to develop protocols and guidelines for the management of psychiatric conditions during infectious disease outbreaks, both locally and globally. table outlines the lessons learned and some recommendations that can be adopted by countries across continents. no 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authors would like to acknowledge the early career psychiatrist section of the world psychiatric association, a supportive network that enabled us to liaise and collaborate on this publication. mio and rdf lead the group discussion and manuscript drafting. mio, rdf, at, rr, vps and mpdc reviewed the manuscript. all the authors agreed on the final draft before submission.j o u r n a l p r e -p r o o f provided their perspective on the management of psychiatric conditions in patients with covid- .• we found commonalities such as similar psychiatric presentations, poor preparedness and alterations in the management of psychiatric conditions coexisting with covid- .• there are shared similarities and differences, likewise modifications in pre-existing protocols in the management of delirium and other psychiatric conditions in patients with covid- and during the current era across continents.• a common factor is the need for preparedness in the mental health sector; the need for concerted efforts targeted at globally and locally sensitive adaptation of guidelines and protocols for the management of psychiatric conditions for the present pandemic and subsequent occurrences. ☒ the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.☐the authors declare the following financial interests/personal relationships which may be considered as potential competing interests: j o u r n a l p r e -p r o o f key: cord- - ofqm a authors: mate, kedar; bryan, caitlin; deen, nigel; mccall, jesse title: review of health systems of the middle east and north africa region date: - - journal: international encyclopedia of public health doi: . /b - - - - . - sha: doc_id: cord_uid: ofqm a this article is an updated version of the previous edition article by francisca ayodeji akala, volume , pp. – , © , elsevier inc. geopolitically, the middle east and north africa (mena) region is strategically situated, with more than half of the countries of the region contributing to a significant proportion of the world's energy production. despite this abundance of resources, there has been modest growth and poverty reduction in the region when compared to others. the region as a whole has, however, achieved significant progress in health outcomes in the past few decades as a result of improved health systems focused on strengthening health service delivery, public health programs, and application of new medical technologies. these achievements at a regional level mask significant disparities among and within countries; these disparities, along with ongoing demographic transitions and epidemiologic changes, pose significant equity and efficiency challenges for mena health systems. this article is an analysis of mena health systems and a review of issues facing them. it highlights the challenges that countries need to address to ensure more efficient and responsive systems. the world bank composition of the mena region will be used primarily in this article; the countries include algeria, bahrain, djibouti, egypt, iran, iraq, jordan, kuwait, lebanon, libya, morocco, oman, qatar, saudi arabia, syria, tunisia, united arab emirates (uae), west bank and gaza (wbg), and yemen. however, where reference is made to world health organization/eastern mediterranean office (who/emro) classification of mena in this article, it will also include data from afghanistan, pakistan, somalia, and sudan but exclude data from algeria. the article begins with a regional overview of the socioeconomic status and health systems achievement in past decades and then addresses current health patterns of the region. before going on to address the health-related challenges facing the region, the article reviews the organization of both biomedical and traditional medical services by detailing issues of access, staffing, and other key health resources, financing, and governance structures. in the last couple of decades, despite modest growth, the mena region has witnessed significant achievements in morbidity and mortality patterns and other measures of health status. these health achievements can largely be attributed to the expansion of health services and public health programs and to educational and socioeconomic developments. in comparison with other countries (in latin america and east asia) of similar per capita incomes, the world bank (iqbal, ) has demonstrated that the mena region has performed favorably on human development indicators in general and more specifically on health outcomes. while mena countries had worse health indicators (using child mortality and life expectancy as proxies) in than comparable countries, the gap had been eliminated by . the average infant mortality rate for the region has dropped from per live births in to per live births in ( table ) . the average life expectancy at birth for the region has increased to years in from years in . however, these regional achievements hide disparities among and within countries of the region. for example, by world bank estimates the infant mortality rate in ranged from per live births in kuwait to in yemen. in egypt in , infant mortality rates were per live births among the poorest-income quintile households and per live births among the highest-income quintile households in the country. mena countries are also diverse in economic terms, with per capita income ( ) ranging from us $ in yemen to us $ in qatar. mena countries can be divided into three main groups that differ in terms of their economic and health outcomes achievements: ( ) low-income countries (yemen and djibouti), which have the highest infant mortality rates and maternal mortality ratios in the region and are facing the greatest health-related challenges; ( ) middle-income countries (algeria, egypt, iran, iraq, jordan, lebanon, libya, morocco, syria, tunisia, and west bank and gaza), which have made significant progress in improving health outcomes although some of these countries continue to face rural/urban disparities in both health outcomes and gaps in health coverage; and ( ) high-income countries of the cooperation council for the arab states of the gulf (ccasg) (bahrain, kuwait, oman, qatar, saudi arabia, and united arab emirates), which have achieved good health outcomes as a benefit of oil revenues used to achieve universal access to health services. political conflicts across the region have had significant impacts on health outcomes achievements and health systems development for many countries (sen et al., ) . from up until , political uprisings, protests, and armed conflicts have affected tunisia, egypt, yemen, bahrain, syria, algeria, iraq, jordan, kuwait, morocco, sudan, and west bank gaza. most of the initial protests of the arab spring ended as of , while others like the large-scale conflict in syria, and between israel and gaza, continue to this day. like many other global governments, mena countries signed on to the millennium development goals (mdgs)a global effort to track key development achievements between and . the region continues to face development challenges, including rapid population growth, high unemployment particularly among the youth, water scarcity, gender inequality, and socioeconomic disparities among the rich and poor that threaten achievement of the mdgs. however, most countries of the mena region are largely on track to achieve the health-related goals including reducing maternal mortality, child mortality and hiv, tb, and malaria morbidity and mortality. as stated earlier, this aggregate regional picture is complicated by disparities in mdg achievement across countries and within countries plagued by significant income inequality. epidemiological and demographic transitions and their effects on morbidity and mortality patterns gaziano ( ) notes that the region as a whole is moving toward the third stage of epidemiological transition, characterized by degenerative and man-made diseases. still, a number of countries face dual burdens of disease characterized by decreasing, but still prevalent, communicable diseases and increasing rates of noncommunicable diseases (ncds). the who estimates that between and the burden of communicable diseases will decline from % to %, while the burden of ncds will increase from % to %. four main trends have driven changes in the leading causes of disability-adjusted life years (dalys) globally: aging populations, increases in ncds, shifts toward disabling causes and away from fatal causes, and changes in risk factors. figure shows that, among ncds, diabetes, anxiety, drug use disorders, low back and other musculoskeletal disorders increased the most in the middle east and north africa between and , while lower respiratory infections, diarrhea, and preterm birth complications decreased between and . (institute for health metrics and evaluation, human development network, the world bank, . the global burden of disease: generating evidence, guiding policy -middle east and north africa regional edition. figure . ihme, seattle, wa.) for low-income countries and rural areas in middle-income countries like egypt and morocco, communicable diseases co-exist with an increasing burden of ncds, dispelling previous notions that ncds mostly affect the affluent. middleand upper-income countries in mena, on the other hand, are mainly burdened by ncds, having largely eliminated communicable diseases. the effects of rapid urbanization ( % of mena's population live in urban areas) and changes in diet and lifestyle are significant contributing factors to the rising rates of ncds in the region. of public health concern is the increasing prevalence of tobacco use in the region, where tobacco-related deaths were projected by murray and lopez ( ) to increase from . % in - . % in . global smoking prevalence data presented by jha et al. ( ) reveal that the overall mena prevalence was %, less than the global average of %. data from who/emro for subsequent years ( ) ( ) ( ) ( ) ( ) indicate that the smoking prevalence rates in the mena region are increasing ( table ) , with prevalence rates among men ranging from . % in oman to % in yemen ( figure ) . the region is also experiencing a nutrition transition characterized by a high prevalence of stunting from undernutrition, particularly in low-income countries and certain geographic areas of middle-to high-income countries. there is also widespread iron-deficiency anemia and other micronutrient deficiencies, along with newer problems related to obesity from overnutrition and their links with ncds/chronic conditions. the adoption of western lifestyles, including decreased physical activity and significant increases in the consumption of energy-dense foods, has led to significant increases in the prevalence of overweight and obese populations. mena along with the pacific islands, southeast asia, and china face the greatest threat of increasing prevalence of overweight and obese children in the world. the rising numbers of road traffic accidents (rtas) is also becoming a major cause of premature mortality in the region and shows no signs of abating, with an increasing number of vehicles overcrowding limited infrastructure. according to who, there was a dramatic increase ( %) in the number of deaths due to rtas from to and the trend has continued since then. kopits and cropper ( ) indicate that in there were about road traffic fatalities in mena and predict that this number will be in , a % increase. peden et al. ( ) reported that at . road traffic deaths per population, low-and middle-income countries of mena have among the highest rates in the world (compared to a global rate of per ). more than people are killed yearly due to road traffic injuries in the mena region, with an estimated cost of more than % of the regional gni. the mena road network carries only % of the world's fleet, yet it contributes to % of the traffic fatalities. the global burden of disease estimates that car crashes are the leading cause of death in mena for the -to -year-old age group since , and will become the leading cause of death for the total population by . figure demonstrates road-crash-related death rates per population of selected mena countries, which are generally higher than the rate for the united kingdom. from to , mena experienced a . -fold increase in population, the highest population growth rate in the world ( figure ) and currently has the second highest annual population growth in the world (at % or nearly million additional people per year). at this rate, mena's population is projected to double in about years (population reference bureau, ) . much of this growth is among the young with % of the population less than years old (un, ) . countries of the region are however at different stages of the demographic transition, ranging from those in the early transition stage with both high birth and death rates, such as yemen and djibouti, right up to those considered to have essentially completed the transition with both low birth and death rates, such as bahrain, kuwait, qatar, and united arab emirates. migration to, from, and within the region is also a significant contributor to the population dynamics in menaboth migration for official employment purposes, as well as due to internal and regional displacement. the oil-exporting countries of the region have hosted millions of foreign workers since the oil boom of the s, with foreign workers constituting anywhere from % to % of workers in these countries. arabs from other mena countries and asians from pakistan, india, the philippines, and indonesia make up the majority of the foreign workers in the oil-exporting countries, which also have to provide services to address health concerns of the workers and their families. in addition, the region has the largest refugee population in the world. according to unhcr, the region experienced the largest growth in internally displaced people (idp) in , increasing % from with numbers expected to continue to rise in . the surge in refugees and idps is likely due to political conflict. countries with already burdened health systems face great difficulties in providing health services to these refugee and idp populations. like the rest of the world, newer diseases such as hiv/aids and highly pathogenic middle east respiratory syndrome (mers-cov) are emerging in mena and posing new challenges. according to the unaids ( ), hiv has been on the rise in the region since , though the overall prevalence remains low and largely limited to high-risk groups (who are also highly marginalized and difficult to reach). the mena region does, however, face the second-highest growth rate of hiv infection in the world. unless effective and timely preventive measures are implemented, the disease could have significant social and economic consequences. akala and el-saharty ( ) estimate that health-related expenditures on hiv/ aids could reach, on average, . % of the gross domestic product (gdp) of mena countries by . economic losses would result from rising mortality and morbidity, which would reduce labor productivity, reduce capital investments, and shrink the labor force. hiv/aids surveillance systems to track the epidemic are particularly weak in the region. the lack of data, combined with high levels of stigma and discrimination against high-risk groups and hiv-infected persons, provides an optimal context for the disease to spread silently. mers-cov, a strain of the coronavirus emerging in the arabian peninsula, has posed a challenging threat to health systems in the region since . cases have been found in saudi arabia, uae, qatar, oman, jordan, kuwait, yemen, lebanon, and iran and have spread to neighboring mena countries, western europe, and as far as the united states (cdc, ) . frequent travel through the region for commercial, religious, and tourism purposes increases the reach of the disease and the possibility of pandemic infection. by , nearly % of the roughly diagnosed mers-cov cases have resulted in fatality. the origin of the virus remains unknown, and human-to-human transmission through close contact is most frequently the source of infection. both biomedical and traditional medical systems exist in the region; while the former predominates, the latter also provides a significant but difficult-to-quantify quantity of services. the following subsections discuss the organization of both systems in mena. mena health systems were originally organized to provide primary health care (phc) services as a means to achieve who-supported "health for all" goals by the year . more recently, the emphasis has shifted to a more curative focus with large investments in acute hospital care. the current curative and hospital-based approach is accompanied by the demographic and health care changes documented above with rising burden of chronic disease. this represents a potential allocative mismatch, with diversion of resources toward acute care while population changes require greater investment in primary care. who assesses that mena will have to address a number of identified weak areas including limited intersectoral cooperation; poor community involvement in planning and provision; weak policy analysis, formulation, coordination, and regulation; weak health information systems; poor organization and management of health services at all levels; and inappropriate human resource policies. the provision of health services in mena had primarily been the role of the state, with centralized financing, regulatory, and delivery infrastructure. in recent years, many governments have begun to separate these functions in order to maximize efficiency and effectiveness of the health sector. governments most often retain the regulatory and policy-making functions. however, mena governments have in many instances shifted service delivery to independent management systems to operate the acute and primary health care delivery infrastructure. financing for health is still in large part via centralized funds, though there are a number of national health insurance schemes with tiered coverage levels and diverse expected sources of funds are on the horizon in the region. more recently, with many governments' inability to fully respond to the population's health service needs, the private medical sector has been expanding to fill gaps in coverage, with resulting concerns about equity, efficiency, and quality assurance due to inadequate regulation of this sector by the government. the private sector is now playing a dominant role in the health sector of many mena countries (including growth in the gulf countries). while historically these private providers focused on curative services and provision of hospital-oriented and capital-intensive services, there has been recent growth of private primary and specialty care services in countries like the united arab emirates among others. by the income groupings already described, low-income countries have developed two-tiered health systems characterized by government and privately provided services. although government services are subsidized and should be available to all citizens, in reality the quality is often suboptimal, with inexperienced staff and poor availability of medical supplies and drugs. in addition, public services on the one hand do not fully cover rural and remote areas of these countries, particularly in yemen where there are significant physical barriers to rural populations accessing these services. access to privately provided services, on the other hand, requires households to make direct out-of-pocket payments that can be impoverishing for the poor. as an example, in , . % of private health expenditures were out-of-pocket and public health expenditure accounted for only % of total health expenditures in yemen ( table ) . in middle-income countries of the region, governments have implemented reforms focusing on the financing and organizational aspects of health systems. social health insurance systems have been implemented to varying degrees among these countries, with many facing issues of population and service coverage particularly for workers in the informal sectors. the gaps in coverage have created the need for various providers, including the private (for-profit and nonprofit) sector and the voluntary sector, leading to fragmented health-care delivery and financing systems for these mena countries. a number of these countries currently have to deal with rising health-care costs and inadequate financial protection at the consumer level. new calls for universal health care coverage issued by global multilateral agencies, like the world health organization, are intensifying pressure on these governments to extend meaningful financial risk protection to all citizens. with significant oil revenues, the upper-income countries have been able to achieve comprehensive health coverage for their populations, either free of charge or at highly subsidized rates. evidence suggests however that this universal access, although generally affordable, could benefit from improved efficiency and quality reforms. although per capita health expenditures are higher among these countries (ranging in from us $ in oman to us $ in qatar), more recently the gcc governments have had to implement cost-containment measures and have begun to consider new financing strategies, including introduction of national health insurance schemes. they also face the challenge of providing health service coverage to foreign workers and their dependants. the system of traditional medicine (tm) in mena has a long history and is still available and used. the who terminology of tm is used here and is a comprehensive terminology that includes both tm systems as well as other forms of indigenous medicine. tm in mena is largely based on an ancient system that is an amalgamation of the tm systems of china, egypt, india, iraq, persia, and syria and is referred to as unani, or arab medicine. unani, according to who, is increasingly being used in the region despite the more readily available biomedical system. tm can generally be administered as medications or nonmedications, with the former mainly including herbal medicines and the latter comprising various techniques which can be performed with or without medications. traditional birth attendants (tba) are also an important part of the tm system in the region. they are patronized mainly by populations in remote and rural areas of most mena countries where, in addition to the age-old cultural practice of tba, there are also significant physical barriers to accessing biomedical services. surveys carried out by khattab et al. ( ) in saudi arabia indicate that significant numbers of women in remote areas continue to patronize tbas despite increasingly available hospital services. this suggests their continued importance in the provision of maternal and child health services in the country. in an environment in which the licensing of tm practitioners is generally absent or not well monitored, it is difficult to quantify clients that patronize tm practitioners. in many mena countries, practitioners provide services that are not regulated and that are mostly patronized by the poor due to easier physical and financial access. while tm is generally accessible and affordable in many mena countries, it is often insufficiently integrated into national health systems. who/emro has previously implemented a regional tm strategy , with the following four key objectives: . to integrate relevant tm with national health-care systems by developing and implementing national tm policies; . to promote safety, efficacy, and quality by expanding the tm safety, efficacy, and quality knowledge base, and by providing guidance on regulatory and quality standards; . to increase the availability and affordability of tm; and . to promote the rational use of tm by providers and consumers. the who released a new strategy for - to address challenges that member countries continue to face. it calls for each member country to build their activities in developing effective policies and regulations around these three strategic sectors: . build the knowledge base on traditional & complimentary medicine (t&cm) so that it can be managed actively through national policies. . strengthen the quality assurance, safety, proper use, and effectiveness of t&cm by regulation and education of products, practices, and practitioners. . promote universal health coverage by integrating t&cm services into health services by capitalizing on their potential to improve health and by ensuring that users are able to make informed choices about their health care. the human resource situation in the region varies among and within countries in terms of quality, quantity, and distribution. mena health systems also face the same global challenges of training, sustaining, and retaining health personnel. table includes the number of physicians per population in - and in - . the average for the region in - was . physicians per population, which is lower than would be expected for a region largely composed of middle-and high-income countries. yemen, morocco, wbg, iran, and iraq have the lowest number of physicians, while lebanon, jordan, and uae have the highest number per population. the quantity of other allied medical staff follows the same general trend as for physicians. the national and expatriate populations in mena countries are increasing rapidly, and the demand on the physical health system infrastructure needed for effective acute care is being pushed to the limits, demonstrated by the overall decrease in hospital beds per people. similar to international trends, most health staff in the region are concentrated in urban areas. rural areas often lack adequate staffing, not only in terms of numbers but also in terms of the required experience of available staff. there is also a shortage of female staff, which presents a major access problem as female health care workers are culturally required to attend to female patients. there are insufficient numbers of public health practitioners to address the ongoing epidemiological transitions in the region. rawaf ( ) notes that public health practitionersespecially physicianshave a low status and low incomes; this factor, along with underdeveloped public health capabilities and infrastructure, lack of structured training and career development opportunities, and lack of data, presents a significant challenge for the region. appropriate policies and management of human resource issues are essential for integrating preventative and health promotion services with curative services and should also be factored into strengthening the curricula of training institutions in the region. according to who/emro less than half of mena countries have adopted or are actively implementing national drug policies, and yet less than a third of the population has regular access to essential drugs. in the absence of functional pharmaceutical regulations, irrational drug prescribing and self-medication are still major challenges in the region, despite the availability of essential drug lists and an abundance of treatment guidelines. the availability of prescription medications in private pharmacies makes self-medication relatively easy. the use of brand name medications instead of generics is also relatively common, and this together with irrational prescription habits contributes to a high proportion of total health expenditure on pharmaceuticals in the region. developing more effective and better-regulated national procurement arrangements can also reduce pharmaceutical spending in countries. given the curative care focus described earlier, spending on medical equipment and technology in mena is also significant and inefficient. health transition-related challenges mena health systems are under increasing pressure to keep pace with epidemiological and demographic transitions. the growing population implies that the cost of providing health services will continue to increase because more people (refugees and foreign workers included) will require basic services, more women will require reproductive health services, more young people will require youth-friendly services, and the aging population will require more specialized care. mena health systems have to adapt to address all these transitions within an environment of limited resources. new approaches and paradigms are needed in the reorganization of the health-care delivery system, which should feature better partnerships by different stakeholders and providers; redistribution of skills mix and enhancing the knowledge of health professionals; better use of primary and acute care services; and the rationalization of existing pharmaceuticals and medical technologies and the appropriate introduction of new ones. with the current curative model of care focusing largely on acute care, mena health systems could greatly benefit from a more strengthened primary health-care approach that not only provides regular and extended care to patients, but integrates preventive and health promotion services together with curative services. patients and their households have a central role to play in the management of chronic conditions since they require daily lifestyle and behavior changes. health systems must be involved in empowering patients to play a more active role in own their care and to link patients to community services that can support their efforts. the emergence of new diseases such as hiv/aids and mers-cov has underscored the need for more effective surveillance systems as an important part of an overarching national monitoring and evaluation system needed to track not only these emerging infections but other existing conditions. a review of disease surveillance systems by who/emro notes that there is insufficient commitment to the systems, lack of practical guidelines, overwhelming reporting requirements, weak involvement of the private sector, lack of transparency, shortage of human resources, and poor data analysis. in the absence of efficient surveillance systems, it becomes difficult to effectively plan and implement measures that proactively curb the widespread transmission or the onset of diseases and to provide timely services for those who need them. along with the need to adapt mena systems to address health and demographic transition challenges is the need to concurrently address challenges related to the who's health systems strengthening building blocks: service delivery, health workforce, information, medical technologies, financing, and leadership (who hss, ) . to address these challenges, political commitment, resources, and management capacity are needed to strengthen existing public health functions or develop them where they are absent. the most critical of these functions include intersectoral policy making, public information and education, and quality assurance and improvement. the management of these functions can only succeed where transparent governance structures exist and where more complex coordination among the different entities beyond the health sector can take place. addressing prevailing service delivery concerns will require a shift from the current curative care model together with more comprehensive rationalization of health resources. in general, there are more hospital beds than needed in most countries of the region and particularly in the public sector, which has a regional average of % of the beds but less than % occupancy rates. maintaining this excess capacity has resource implications. instead of the current focus on expanding the hospital-based infrastructure, more critical is the need to reconfigure the mena health system to better integrate the provision of preventative and promotional services with treatment and support services. with the growing population, mena health systems require a stronger emphasis on services and functions aimed at reducing the population's level of exposure to existing risks of emerging challenges, rather than the more expensive option of treating them when affected. in addition, a surveillance and treatment infrastructure designed to swiftly address modern health care threats from epidemics of mers co-v and other dangerous pathogens needs to be developed in the near term. the health care workforce of the mena region is very diverse, with staff hailing from virtually every corner of the world in great numbers. this diversity is both an incredible asset to the health sector of the region, as well as one of its greatest vulnerabilities. recruitment and retention of the workforce is a key initial challenge. professional licensing and ongoing continuous medical and nursing education and recertification for all professionals is another key challenge. finally, a diverse health care workforce needs strong organizational culture with clear and easily understood standards and policies, values-based leadership, and a sense of accountability for performance. data collection, management, and reporting are increasingly a part of any modern health care delivery system. this is true in the mena region as it is elsewhere in the world. addressing systemic challenges will require more comprehensive health information systems that provide relevant data that are readily available for assessing priorities as well as for planning, managing, and implementing the required services. unfortunately, the region generally lacks available, reliable, timely data to guide these processes. many countries and large systems are investing substantively in electronic data capture and reporting systems; some are investing in electronic health records at the service delivery level. these systems afford the opportunity to produce data about system and clinical performance that could aid mena health system managers to make more rational and evidence-informed decisions about how to improve the health system in the future. availability of critical technologies, medical products, vaccines, and other technologies is increasingly challenging in a geopolitical region that is riddled with conflict, war, and geographic adversity, with rural populations that are spread across an enormous geographic territory. in addition to these challenges, rational procurement and importation issues will present mena countries with challenges in the near term. improving and sustaining achievements of national health systems in the region becomes even more challenging within the context of a growing population, especially one with a high economic dependency rate. with % of the population less than years of age and the highest unemployment rate, the proportion of the mena population that is economically active is the lowest in the world. this has implications for how health insurance schemes in the region (social and private) can be more efficiently managed and maintained. the high dependency ratio adds more fiscal pressure on limited government health budgets, which need to be better targeted at addressing the needs of the most vulnerable populations. governments can also take better advantage of the growing private health sector by fully regulating them and ensuring that private along with public investments are made in more cost-effective technologies. financing considerations will require extending financial protection to those who most need it. with the exception of a few countries (saudi arabia, oman, and uae), out-of-pocket expenditures accounted for at least % of private health expenditures in (see table ), which disproportionately affects the poorer populations, who can be further impoverished in the event of a catastrophic illness. mena governments are increasingly interested in extending financial protection and improving access to health services by using different risk-pooling mechanisms, including social and private health insurance, and could benefit from global experiences in achieving these. well-targeted social safety nets are needed to ensure adequate protection of citizens against the impoverishing effects of ill health. finally, leadership systems of many mena health care systems have undergone substantial turnover with changes to governments in the region. where leadership and governance have been relatively stable, leaders are often challenged by limited support beyond the top-most level of leadership, inadequate ongoing leadership skill development, incomplete information for management, and many competing priorities expressed by varied stakeholders in the system (patients, providers, and policy-makers, to name a few). these are not unique situations to leading health systems anywhere in the world, but combined with some of the other challenges noted above, mena health care system leaders are particularly challenged to deliver on the promise of providing high quality, effective, efficient, and equitable health care services to the populations of the mena region. the region clearly faces a multitude of challenges at various levels and scope, with some easier to address than others. governments have the complicated task of defining the priorities and determining the best options for addressing them within budget-constrained environments. to effectively and efficiently respond to these challenges, mena governments must also have the political will to involve key stakeholders in the planning, implementation, and management of health systems. the mena region is not alone in trying to keep pace with the current and future health-related transitions; all other regions have their own similar and yet unique sets of challenges. the beauty of globalization is that regions and countries can benefit from others and share their experiences and ideas in tackling these challenges together. public-health challenges in the middle east and north africa reducing the growing burden of cardiovascular disease in the developing world better governance for development in the middle east and north africa region: enhancing inclusiveness and accountability sustaining gains in poverty reduction and human development in the middle east and north africa estimates of global and regional smoking prevalence in , by age and sex the need for traditional birth attendants (dayas) in saudi arabia traffic fatalities and economic growth how arabs compare: arab human development report the global burden of disease: a comprehensive assessment of mortality and disability from disease, injuries and risk factors in projected to population trends and challenges in the middle east and north africa public health functions and infrastructures in mena/em region syria: effects of conflict and sanctions on public health world population prospects arab human development report : towards freedom in the arab world eastern mediterranean region country profile world development indicators. the world bank everybody's business: strengthening health systems to improve health outcomes: who's framework for action traditional medicine strategy world health organization patterns of belief and use of traditional remedies by diabetic patients in mecca, saudi arabia traditional healers in the qazvin region of the islamic republic of iran: a qualitative study hiv/aids in the middle east and north africa: the costs of inaction international migration: facing the challenge public health in the middle east and north africa: meeting the challenges of the twenty-first century. the world bank preventing hiv/aids in the middle east and north africa: a window of opportunity to act health : regional health-for-all policy and strategy for the st century. who/emro (original in arabic) the work of who in the eastern mediterranean region: annual report of the regional director the who strategy for traditional medicine: review of the global situation and strategy implementation in the eastern mediterranean region health and human security center for population and development studies at the harvard school of public health the authors would like to thank jane roessner for review, editing, and advice on this manuscript.see also: centers for disease control; nongovernmental organizations (ngos); southeastern europe, health systems of. key: cord- -bkydu authors: luis silva, l.; dutra, a. c.; iora, p. h.; ramajo, g. l. r.; messias, g. a. f.; gualda, i. a. p.; scheidt, j. f. h. c.; amaral, p. v. m. d.; staton, c.; rocha, t. a. h.; andrade, l.; vissoci, j. r. n. title: brazil health care system preparation against covid- date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: bkydu background: the coronavirus disease outbreak from (covid- ) is associated with a severe acute respiratory syndrome coronavirus (sars-cov- ), a highly contagious virus that claimed thousands of lives around the world and disrupted the health system in many countries. the assessment of emergency capacity in every country is a necessary part of the covid- response efforts. thus, it is extremely recommended to evaluate the health care system to prepare the country to tackle covid- challenges. methods and findings: a retrospective and ecological study was performed with data retrieved from the public national healthcare database (datasus). numbers of intensive care unit and infirmary beds, general or intensivists physicians, nurses, nursing technicians, and ventilators from each regional health unity were extracted, and the beds per health professionals and ventilators per population rates were assessed. the accessibility to health services was also performed using a spatial overlay approach to verify regions that lack assistance. it was found that brazil lacks equity, integrity, and may struggle to assist with high complexity for the covid- patients in many regions of the country. conclusions: brazilian health system is insufficient to tackle the covid- in some regions of the country where the coronavirus may be responsible for high rates of morbidity and mortality. the coronavirus disease is associated with the novel severe acute respiratory syndrome coronavirus- (sars-cov- ) identified in december ( ) . as of may , , covid- has globally infected , , people resulting in , deaths ( ) [report ]. the who declared covid- a public health emergency of international concern (pheic) by the end of january under the international health regulations (ihr) ( ) . few weeks after the pheic declaration, the covid- outbreak was declared to be a pandemic, drawing attention worldwide ( ) . the pandemic led to the adoption of several non-pharmacological interventions ranging from social distancing guidelines to national-level lockdowns by different countries ( ) . these stringent interventions have severely impacted the way of living of many people and disrupted the already precarious health system in many countries ( ) . in response to the covid- pandemic, several countries undertook analyses for the necessary health system strengthening efforts. according to studies dedicated to characterizing the clinical evolution of the disease, % of the cases demand emergency care, with a subset of % needing icu and . % demanding ventilator support to sustain life ( ) . in the u.s., the percentage of patients needing ventilator support was even higher, reaching up to , %. the response effort to tackle the covid- requires a strong organization of the emergency network ( ) . the lack of beds, iniquities in the distribution of hospitals, and inadequate availability of ventilators could hamper the actions aiming to decrease the negative consequences of the covid- ( ) . unfortunately, usually, the distribution of the health resources within the countries are characterized by inequities ( ) . due to the covid- consequences, the scenario faced by low and medium-income countries is even more staggering ( ) . the historic challenges regarding an insufficient number of health professionals, iniquities in the distribution of human resources ( ) , low accessibility to emergency care services ( ) , and economic issues create additional pressures to be addressed, aiming is to achieve an adequate covid- response. as the covid- spreads around the world, the hospital systems lack measures against the virus ( ) , and many countries are experiencing shortages of hospital supplies ( ) . for example, as of march , in italy, where there were , cases of covid- and deaths, , of , beds in intensive care units (icu) are occupied. a few days later, there were no more icu beds available ( ). in the united states of america, it is estimated that the disease will stress bed capacity, equipment, and health care personnel, as never seen before ( ) . the brazilian case is not an exception ( ) . in order to reduce the burden of covid- , the hospital administrators, governments, policy-makers, and researchers must be prepared for a surge in the healthcare system ( ) . brazil is characterized by severe social disparities and health inequities. on may , cases were confirmed and , deaths ( ) (https://covid.saude.gov.br/). however, this number is under-reported, and the real number is estimated to be nine times greater, . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint according to some simulations ( ) . to further the concern, the imperial college estimates that up to million people will fall ill due to covid- in brazil ( ) . during the last decade, brazil is struggling to increase the funding of the public unified system (sus). despite the efforts performed in , the constitution amendment (e.c. acronym in portuguese) reduced the budget of the ministry of health by almost seven billion reais by year ( ) . before the ec , the brazilian health system was already underfunded ( ) . two years after the ec , the consequences regarding the lack of funding were aggravated by the covid- pandemic. additionally, brazil is also facing a political crisis contributing to divergences between the administrative levels in the country. the consequences of all these elements combined could hamper the response actions to tackle the covid- . the availability of information during a crisis is essential to support the decision-making process based on evidence. taking this point into consideration the present work addresses critical aspects regarding the organization of the emergency network system in brazil, jointly with the spatial expansion of covid- cases within the country, and to highlight where the efforts currently performed in brazil were capable of coping with the lack of access to emergency care needed to cope covid- consequences. the present paper is an ecological, observational, and cross-sectional study using a spatial analysis approach. the data sources are based on secondary data from the unified health system (sus) ( ) . to fulfill the defined objective, the adequacy parameters in terms of human resources, health care structure, and accessibility to emergency care services were analyzed in comparison with the reported incidence of covid- . according to data from the brazilian institute of geography and statistics (ibge), brazil is located in south america with a territorial area of . . , km and has a total of , , inhabitants, with human development index (hdi) of . with diversified values for the municipalities ranging from . to . (figure ) ( ). for the assessment of methodological quality, we followed the guideline strengthening the reporting of observational studies in epidemiology (strobe). to characterize the brazilian emergency care services network, three sources were used: national register of health facilities (cnes acronym in portuguese), population data from the ibge, and covid- cases reported by secretariat of surveillance of the ministry of health (https://covid.saude.gov.br/). data regarding hospitals, professionals (nurses, nursing technicians, doctors, and physiotherapists), and equipment (ventilators, icu, and infirmary beds) were obtained from . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint the cnes website using r through the microdatasus package ( ) . the population data and thematic maps were fetched from the ibge ( ). the match between the number of health professionals and the recommended suitability parameters were compared using the guidelines from the national health surveillance agency (anvisa) resolution of the collegiate board of directors (rdc). the anvisa rdc number provides the minimum requirements for the operation of intensive care units, in which ten icu beds are required for each one intensive care physician and one physiotherapist, one intensive care nurse for every eight beds, and two nursing assistants for each bed ( ) the building of thematic maps was carried out by grouping the municipalities by health regions unity (h.r.) using software qgis . . the (h.r.) is a continuous geographic space constituted by a group of bordering municipalities delimited by cultural, economic, and social identities, created by the ministry of health in order to mitigate the disparities in the country ( ) . . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . to identify regions with a high incidence of covid- , simultaneously presenting a lack of emergency network was used as a spatial overlay approach. the first step comprised the development of an emergency infrastructure index (eii). the eii was obtained computing the number of beds registered, by the ratio of professionals and equipment according to the last competence of february from cnes. to evaluate the geographical accessibility to emergency care service care was used the two-step floating catchment area ( sfca) technique. with this approach, it was possible to assess the accessibility to emergency care services by the interaction of two geographic characteristics: (a) the volume of available hospital beds weighted by population within hours of travel distance, and (b) the proximity of hospitals within a hours displacement from . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint each municipality ( ) . the sfca method generated two accessibility indexes for each municipality in brazil, one regarding the network available in february , and a secondary one highlighting where the covid- new exclusive beds increased the access to emergency services. both indexes created the conditions to identify regions with a lack of access to emergency care, as well as the regions being benefited by the expansion of the icu beds dedicated to the codvid- response. to highlight regions with a high incidence of covid- and a lack of emergency structure, an overlap analysis was conducted to select the municipalities concurrently, showing a pattern of high incidence, jointly with a lack of access to emergency services. once the eii was computed, and the municipalities with high incidence within regions with low access to emergency care services care were identified, a getis-ord-gi analysis was performed. thus, it was possible to point out three spatial clusters: ( ) emergency care services accessibility on february ; ( ) municipalities with low access to emergency care services and high covid- incidence, ( ) accessibility to icu beds exclusively dedicated to covid- response in march . following the resolution no. / of the national health council and considering that we used secondary sources which are available in governmental and online databases, the dispensation of the consent form was requested to the ethics committee. covid- has shown a fast growth rate in brazil. the total number of confirmed deaths in the country initially increased at a similar pace as germany and iran. however, differently than these countries, it has not yet shown a decrease in its growth rate ( figure a) . subnationally, the growth rate of confirmed deaths shows an unequal pattern. likely due to different state-level isolation policies, the states of são paulo, rio de janeiro, ceará, and amazonas have shown a much faster growth rate than the rest of the country ( figure b) . nonetheless, the country as a whole seems to be still far from its peak number of new deaths by covid- . . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . february ) . in terms of professionals and beds per , inhabitants, the southern region had the highest rates for icu beds, ventilators, physicians, nurses, and technicians. in contrast, the northern region had the lowest ones (table ). figure shows the rates of beds and professionals per health regions. the icu beds per intensivist varied from zero to , zero to . per intensive care nurse, zero to . per technician, and zero to per physiotherapist. in addition, hospital beds per physician varied from . to . , . to . per nurse, . to . per technician, and . to . per physiotherapist. figure shows the distribution of professionals, beds, and ventilators throughout the territory, and classifies this distribution according to rdc number . in a, most h.r. is by the rdc, which determines up to intensivists for each icu bed. however, hr do not have icu beds and / or have no intensivist. in b, only h.r. are working according to the recommended amount of critical care nurse for each icu beds. c and d show that hr are working correctly with the capacity of nursing assistant and one physiotherapist for every and beds, respectively. in the second row of figure , f, g, and h show that there are nurses, nursing technicians and physiotherapists working above the limit of nurse per infirmary bed, one nursing technician for each two-infirmary bed and one physiotherapist per infirmary bed. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . panel a in figure depicts the covid- incidence by the brazilian municipality up to / / . it is possible to observe that all states and regions currently are presenting covid- cases with a highlight to the states of amazonas, amapá, espírito santo, and santa catarina, where it is already noted areas with hot colors. the hot colors indicate higher levels of incidence. in terms of deaths, all state capitals of the north, northeast, and southeast regions are presenting high levels of mortality when compared with the rest of the country. figure presents three maps characterizing the brazilian situation in terms of emergency services and the covid- incidence. panel a exhibits the accessibility index to icu beds by population. the map highlights a higher accessibility index close to the state capitals of the brazilian states. the map b emphasizes the municipalities presenting a covid- incidence higher than the national average of . , simultaneously with an accessibility index lower than the national mean per , inhabitants thus, every municipality in the map b is facing challenges in terms of emergency care services and a high covid- incidence for the brazilian standards. map c presents the accessibility index of the new beds created exclusively to offer intensive care to covid- patients. few beds with this specific purpose were open in the states of the north and midwest region of the country. figure shows the result of spatial clustering analysis to identify trends in access, as well as in the covid- incidence. panel a exhibits a hot spot covering the southeast, midwest, and south regions of the country. the states covered by the red layer presents the spatially significant group of municipalities with higher levels of access to icu beds by population. on the opposite side, the blue layer highlights the regions facing geographical barriers to grant access to icu beds to the population. to build the map b, the same approach was used, but this time only applied to the municipalities with high covid- incidence and a low index of accessibility to icu beds. the red color characterized a group of municipalities in the south and midwest regions. despite the higher availability of beds in these regions, it was possible to observe a statistically significant group of municipalities within these regions with barriers to access icu beds. map c illustrates the cluster of accessibility regarding the icu beds created to tackle the covid- . the lack of overlay between the red color of maps b and c is pointing out a mismatch of the response efforts dedicated to addressing the covid- challenge. the regions in map b characterized as hotspots were considered cold spots regarding the creation of icu beds dedicated to covid- . the result suggests that the use of scarce resources needed to put in order icu beds are not being directed to municipalities lacking access to emergency care services, despite their high levels of covid- incidence. the ongoing covid- pandemic has caused nearly million confirmed cases and claimed over , lives worldwide as of may , ( ) [report ]. it is noteworthy to mention that the covid- outbreak is a challenge to the health systems worldwide ( ) , and although the outcome for the crisis caused by this disease is uncertain, sars-cov- will overwhelm health care infrastructure for months ( ) . in this study, the brazilian health system was evaluated to verify its capacity to tackle the covid- challenge. according to the who, it is recommended one doctor and one nurse per , inhabitants as a parameter of health care for the population ( ). to strengthen the who recommendations, the brazilian health governments has established in the resolution of the collegiate board of directors number / , the quantities of icu and infirmary beds per intensivists, general physicians, nurses, nursing technician and physiotherapists ( ) . although table shows that in brazil, there is a sufficient number of physicians in the country, figure shows that these professionals are not evenly distributed to accomplish the who recommendations and cbr. in addition, the number of nurses does not meet the criteria in the north and midwest. to illustrate the problem, figure shows that brazil has desert zones of icu assistance and regions where these professionals have to take care of beds far beyond the quantities stipulated by the rdc. bahtt et al., verified that professionals in critical care that were caring for more patients per shift were more likely to experience burnout ( ). halpern et al., informed that intensivists are also in shortage in the united states of america, and this situation may be attributed to burnout ( ) . therefore, the combat against the covid- may be a difficult task in these regions, since providing access and affordable care for the large urban populations is already a challenge for many countries ( ). experience from lombardia has shown that % of patients with covid- were admitted in the icu treatment, whereas this number varied from to % in some cities in china ( ) . on the other hand, in brazil, there are no available large data of icu patients at the moment, and supposing that those numbers might appear in the country as well, only out of health regionals could manage this number of patients. in terms of nursing care in icu accessibility, figure shows that there are large regions of care voids, probably because there are low amounts of icu nurses in brazil ( ) . besides that, it's possible to visualize that there are regions where icu and generalist nurses are responsible for more than eight icu and infirmary beds, which may represent a risk of unfavorable outcome for the covid- treatment since that high amount of patients per nurse are associated with a range of negative patient outcomes ( , ) . the pandemic has led to severe shortages of many essential supplies, such as icu beds and ventilators ( ) . based on italy's numbers that to % of hospitalized patients will require ventilation, the centers for disease control and prevention estimates that in the usa, there will be between . to patients per ventilator this period ( , ). brazil, on the other hand, . to . million people will require hospitalization, according to the imperial . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . college of london ( ) , which represents to patients per ventilator if distributed equally. the numbers may represent a satisfactory amount of equipment. however, figure shows that there are no ventilators in some h.r. that are potential places to have a high number of deaths. the most staggering result was obtained through the spatial cluster analysis. brazil is currently facing a double crisis. the political positioning of the president is going against the technical recommendations of the ministry of health and who. consequently, there is a disagreement between the federal administration, and the states and municipalities. on account of that situation, each administrative level is conducting several response actions against covid- without country-level coordination. the spatial clusters analysis highlighted that new beds created to tackle the covid- were misplaced. the hot spot clusters of municipalities with high incidence and lack of access are not overlapping with the hot spot cluster of new beds dedicated to the covid- . this situation calls attention for the misplacement of scarce resources during a pandemic. the scenario depicted is the result of a lack of coordination at the national level. the consequence of misplacing the new covid- icu beds is an increase in the chance of deaths due to a lack of emergency care services for municipalities currently presenting a covid- incidence above the national average. from now on, brazil has several difficulties in treating patients in critical care. this paper shows that there is an insufficient number of icu beds, ventilators, and a huge lack of professionals in healthcare. additionally, the misplacement of the new beds aiming to fight the covid- pandemic contributes to worsening the situation observed through the other indicators assessed. developed countries like italy and the united states demonstrate that covid- can overwhelm the healthcare capacities of well-resourced nations very fast ( , ) . therefore, the sars-cov- epidemic in middle-income countries, such as brazil ( ), may be devastating. our findings suggest that strong leadership is needed to coordinate the response efforts against the covid- . the limitations of this work rely on the complex data available. health data from health information systems, including health-facility records, surveys, or vital statistics, may not be representative of the entire population of a country and, in some cases, may not even be accurate ( ). the cnes database presents some limitations well known by the brazilian scientific community ( ) . despite this, the information regarding the availability of covid- beds was published just a month ago, calling attention to the occurrence of efforts aiming to improve the quality of the data available to policymakers. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint a" iv to "z" ikv: attacks from emerging and re-emerging pathogens covid- ): situation report clinical characteristics of coronavirus disease in china world health organization declares global emergency: a review of the covid- : extending or relaxing distancing control measures. lancet public health deep impact of covid- in the healthcare of latin america: the case of brazil communication, collaboration and cooperation can stop the coronavirus intensive care management of coronavirus disease (covid- ): challenges and recommendations global surgery : evidence and solutions for achieving health, welfare, and economic development addressing inequalities in medical workforce distribution: evidence from a quasiexperimental study in brazil addressing geographic access barriers to emergency care services: a national ecologic study of hospitals in brazil universal masking in hospitals in the covid- era fangcang shelter hospitals: a novel concept for responding to public health emergencies how should u.s. hospitals prepare for coronavirus disease (covid- )? covid- ): update for anesthesiologists and intensivists the immune escape mechanisms of mycobacterium tuberculosis comparison of the microwave-heated ziehl-neelsen stain and conventional ziehl-neelsen method in the detection of acid-fast bacilli in lymph node biopsies. open access maced the global impact of covid- and strategies for mitigation and suppression. imperial college covid- response team emenda constitucional / e o teto dos gastos públicos: brasil de volta ao estado de exceção econômico e ao capitalismo do desastre implicações de decisões e discussões recentes para o financiamento do sistema Único de saúde. saúde em debate regulamenta a lei no . , de de setembro de , para dispor sobre a organização do sistema Único de saúde-sus, o planejamento da saúde, a assistência à saúde ea articulação interfederativa, e dá outras providências microdatasus: pacote para download e préprocessamento de microdados do departamento de informática do sus (datasus). cadernos de saúde pública dispõe sobre os requisitos mínimos para funcionamento de unidades de terapia intensiva e dá outras providências brasília região de saúde e suas redes de atenção: modelo organizativo-sistêmico do sus. ciência & saúde coletiva covid- : operational guidance for maintaining essential health services during an outbreak: interim guidance world health o. health workforce requirements for universal health coverage and the sustainable development goals.(human resources for health observer, ). . critical care medicine in the united states: addressing the intensivist shortage and image of the specialty organizational characteristics, outcomes, and resource use in brazilian intensive care units: the orchestra study baseline characteristics and outcomes of patients infected with sars-cov- admitted to icus of the lombardy region profile of an intensive care nurse in different regions of brazil ratios and nurse staffing: the vexed case of emergency departments workloads in australian emergency departments a descriptive study the toughest triage -allocating ventilators in a pandemic hospital surge capacity in a tertiary emergency referral centre during the covid- outbreak in italy factors potentially associated with the decision of admission to the intensive care unit in a middle-income country: a survey of brazilian physicians. rev bras ter intensiva cadastro nacional de estabelecimentos de saúde: evidências sobre a confiabilidade dos dados. ciênc. saúde coletiva [internet] we would like to thank the coordination for the improvement of higher education personnel (capes). the authors declare no conflicts of interest. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , key: cord- -ebjwkvvj authors: li, hui; hilsenrath, peter title: organization and finance of china’s health sector: historical antecedents for macroeconomic structural adjustment date: - - journal: inquiry doi: . / sha: doc_id: cord_uid: ebjwkvvj china has exploded onto the world economy over the past few decades and is undergoing rapid transformation toward relatively more services. the health sector is an important part of this transition. this article provides a historical account of the development of health care in china since . it also focuses on health insurance and macroeconomic structural adjustment to less saving and more consumption. in particular, the question of how health insurance impacts precautionary savings is considered. multivariate analysis using data from to is employed. the household savings rate is the dependent variable in models segmented for rural and urban populations. independent variables include out-of-pocket health expenditures, health insurance payouts, housing expenditure, education expenditure, and consumption as a share of gross domestic product (gdp). out-of-pocket health expenditures were positively correlated with household savings rates. but health insurance remains weak, and increased payouts by health insurers have not been associated with lower levels of household savings so far. housing was positively correlated, whereas education had a negative association with savings rates. this latter finding was unexpected. perhaps education is perceived as investment and a substitute for savings. china’s shift toward a more service-oriented economy includes growing dependence on the health sector. better health insurance is an important part of this evolution. the organization and finance of health care is integrally linked with macroeconomic policy in an environment constrained by prevailing institutional convention. problems of agency relationships, professional hegemony, and special interest politics feature prominently, as they do elsewhere. china also has a dual approach to medicine relying heavily on providers of traditional chinese medicine. both of these segments will take part in china’s evolution, adding another layer of complexity to policy. the rapid rise of china on the world economic stage has been impressive. a nation of . billion people has transformed from a primarily poor rural society to a prosperous majority urban one. china has divisions and controls between rural and urban populations partly to stem development of urban slums. this helps explain wide disparities in income and separate national accounting conventions. urban per capita disposable income was already % greater than rural income in , and the gap is even larger now. but both urban and rural populations have seen sharp gains with real urban per capita disposable income in at % of the level. real rural incomes were % of levels. the world bank placed china at $ in purchasing power parity per capita income in , just above south africa ($ , ). this transition did not come easy. in , china cast off the centuries-old qing dynasty in an effort to modernize. decades later, and after much tumult, communists consolidated power seeking economic growth and social advancement relying on a command economy. this approach was found wanting and replaced by a more market-friendly strategy. economic growth has been brisk since and is only now decelerating for fundamentally structural reasons. growth has been fueled by movement of low-productivity agricultural workers to higher productivity manufacturing, construction, and service employment. it has also been underpinned by high levels of investment and exports. in addition, china, like other developing countries, benefits from the integration of a backlog of technologies readily available from the developed world. this approach inevitably exhausts itself as the rural population diminishes, higher wages and prices render manufactured exports less competitive, and higher productivity technologies become widely disseminated. structural adjustment away from manufacturing, investment, and exports and toward consumption and services, both public and private, is already underway. the chinese leadership now emphasizes the quality of economic growth rather than its high rate and struggles to set expectations for a new normal where living standards increase at slower rates. the future also promises greater abundance of social amenities including better environmental quality and a stronger social safety net, of which health services are an important part. the purpose of this article is to provide a narrative history of how china's health sector evolved since . this story is of interest, but there are important secondary considerations. increasing allocations to health insurance and health services are central to the transition toward consumption and services. a multivariate analysis of savings rates is included premised by a hypothesis of expected health care costinduced precautionary savings. the article posits that better health insurance coverage and health care access reduces precautionary saving and increases household consumption, an essential part of macroeconomic structural adjustment. chinese history is deeply rooted with millennia of tradition and culture. china was well organized and productive for much of its history, achieving impressive levels of prosperity and population. chinese medicine is part of that evolution with a rich legacy of theories, drugs, and procedures. western medicine is a relative newcomer. some trace it to matteo ricci in the th century and subsequent work by christian missionaries. by the th century, both approaches coexisted with western medicine linked to missionaries and universities. but overall, infrastructure was rudimentary, and traditional medicine served most of the population when the communist party prevailed in . traditional medicine remains widely accepted throughout china. communist ascendency occurred in china while stalin still presided in the soviet union. the union of soviet socialist republics (ussr) was a template. but unlike the soviet union where lenin and stalin sought proletarian transformation, mao relied on a more rural and agricultural approach with formation of cooperatives as a key feature of early planning. the rural cooperative medical system was established to provide health care for much of the population. like the soviets, china quickly developed a command economy with guidance provided in the five-year plan for - . the first of the five-year plans included nearly projects with a focus on heavy industry. they were capital intensive with little emphasis on household consumption. there was some attention to the health sector, however, with priorities of hospital and clinic construction, vaccine and drug production, and training of health care providers. many of the objectives of the first five-year plan were met, although agricultural output lagged. public health was recognized as an important element of planning. china experienced marked improvements in public health and primary care by the late s. the great leap forward from to , an effort to induce small-scale industrial activity and collectivization, backfired and ensuing havoc in agriculture resulted in devastating famine. soon after came the cultural revolution, with emphasis on purging social class. it also shattered economic activity resulting in serious setbacks. the more pragmatic deng xiaoping set a different course for china once he consolidated power in the late s. the late s were watershed years in china. the shift to a more market-based system commenced and was outlined in the sixth five-year plan for - . it identified prices as key for resource allocation as opposed to command approaches. it called for use of new technology and some banking reform. it also sought to shift resources toward consumption and away from investment, at least in relative terms. environmental protection is mentioned as well. health planning in the sixth five-year plan called for further hospital and clinic expansion as well as improvements in quality and competencies of staff. increased drug output was included with considerable emphasis on improved quality. the plan also called for more and better integration of western and traditional medicine, and it sought to intensify education of barefoot doctors who provided much of primary care during the cultural revolution, but were generally not well trained. the decisive shift toward markets that propelled china to become one of the world's largest economies was much more managed than the collapse of central planning in the former soviet union. the implementation of china's five-year plans was already relatively decentralized by the s. further devolution of the locus of authority along with profit incentives animated both rural agriculture and state-owned enterprises to substantially higher levels of output. this was combined with trade liberalization especially in some coastal regions that attracted western direct investment. success in this approach led to more such reform and greater financial self-sufficiency among organizations. this impact of reform on the health sector was profound. rural residents who previously enjoyed some measure of access to health services through rural cooperatives were largely left uninsured. , many urban residents, such as those with employment in state-owned enterprises, did maintain coverage through social insurance plans for urban workers and state-owned enterprises, but others did not. hospitals received relatively small and inadequate allocations of funds from the public sector and many turned to sales of drugs, devices, and newer procedures. the government permitted hospitals a % mark-up rate on drugs, except for those on the essential drug list with no mark-ups. physicians, many employed at hospitals on modest salaries, also sought to supplement incomes with drug or device sales. chinese households were aware of the financial impact of high hospital costs and many self-insured with precautionary savings. nevertheless, financial ruin threatened when expensive health care was required. china's health sector grew rapidly in this period but not always as fast as gross domestic product (gdp). for example, nominal health spending nearly doubled from to , but the share of gdp allocated to health fell from . % to . %. growth of the health sector was increasingly financed from out-of-pocket household spending. figure by the turn of the century, there was growing consensus that organizational self-sufficiency in china's health sector in the absence of much more widespread insurance was problematic. there was also a serious public health scare with severe acute respiratory syndrome (sars). china's public health infrastructure was found inadequate, and both domestic and international constituencies called for reform. a middle ground had to be found between the public sector approach of the s and reliance on out-of-pocket spending. but there was no international consensus on the appropriate role for the state in the health sector. so china opted for a -track approach of increasing state allocations to public health, public hospitals, and clinics as well as implementation of health insurance expansion to provide universal coverage. the latter effort began with the rural population in . two urban schemes, the urban employee basic medical insurance (uebmi) and urban resident basic medical insurance (urbmi) programs, were subsequently established. the former integrated the working population previously covered with social insurance, whereas the latter serves non-working populations. the th five-year plan for - emphasized improved basic medical insurance while also calling for improved hospital and clinic infrastructure including management, public health and medical education, and increased use of information technology in health. this five-year plan also accords equal importance to traditional and western medicine, underscoring the continued importance of this form of alternative medicine. near-universal health insurance has been achieved though problems of rural migrants to cities remain. it is also the case that coverage is shallow. coverage is focused on hospitalizations with annual limits on insurance expenditure and substantial cost sharing. the population remains vulnerable to catastrophic financial loss, especially as health care prices rise. this system is relatively weak but forms a foundation with which to provide more comprehensive and efficient coverage later. health spending is income elastic, and over the long run, the share of gdp allocated to health increases as per capita income rises. this is shown in figure using world development indicators from the world bank. it shows the share of gdp allocated to health in and per capita income measured in purchasing power parity in . china, where the health sector accounts for . % of gdp, is very close to the trend-line. rising per capita income is expected to drive up this share. the shift to services has important implications. services, including those in health care, have historically shown relatively weak productivity growth, and more services, though a ready source of employment, threaten to lock in slower growth. however, perhaps china can leapfrog other nations and transform its hospital and pharmacy centric system with the use of higher productivity mobile health applications and other new technologies. past development in china has shown no conclusive leapfrogging, but the possibility exists. china's shift toward consumption and services has drawn the attention of the imf. , stability and integrity of the global balance of payments depend on orderly evolution of china's economy. china has exceptionally low levels of consumption and high levels of savings as a share of gdp by global standards. household consumption accounted for just . % of gdp in . by comparison, household consumption in the united states accounted for . % of gdp. lower consumption rates in developing countries are expected, but china's low consumption levels are extraordinary. reduced savings rates and higher consumption rates are a central objective for china. , china would be on a more sustainable path, and higher consumption will drive imports, stimulating growth elsewhere. barnett and brooks of the imf analyzed determinants of consumption and savings and found that precautionary savings for health were an important reason chinese save more and spend less than others. of course, other factors can drive savings, such as expected future education and retirement spending as well as home purchases. a related study found that consumption of durables such as washing machines and color tvs was positively related to the number and proportion of rural households with health insurance. but not all studies support the hypothesis that wider and deeper health insurance increases consumer spending. , the low level of consumption in china's economy impacts savings, and inclusion of this can yield different results. to that end, this article addresses determinants of savings and includes rural and urban models with and without consumption/gdp as an independent variable. narrative history is the primary approach used in this study, but multivariate analysis is also used as a supplement. primary data sources include various editions of the china statistical yearbook and the chinese health sector statistical yearbook for - . these are compendium of public sector data. the world bank and the imf are also important sources of secondary data. multivariate analyses use ordinary least squares analysis in spss version . and excel for windows to study determinants of household savings. urban and rural data are analyzed separately consistent with chinese statistical accouting practice. the first model includes only two independent variables: out-of-pocket health spending and health insurance payouts by insurers. the second model adds residential home and education spending. these models form the base case of the analysis. but urban and rural data are also augmented in separate models with consumption/gdp included as an independent variable. a disaggregation into two periods, to and to , was also included. the general model specification is as follows: the dependent variable (y) is the urban or rural household savings rate. independent variables (x i ) in the base case include out-of-pocket health expenditures, health insurer payout, residential house spending, and education spending. all of these variables are standardized as a share of per capita urban disposable income or rural income. for urban households, health insurance refers to the uebmi and the urbmi schemes. for rural households, health insurance refers to new rural cooperative medical system (nrcms). data for savings rates are derived from household surveys. savings is the difference between per capita disposable income and per capita consumption expressed as a proportion of per capita disposable income. data for the independent variable of outof-pocket spending were obtained from national health expenditures accounts and measure per capita health spending as a share of disposable income. data for payout of health insurers are used to measure these expenditures relative to per capita disposable income even though they are not part of disposable income. this helps to standardize this independent variable. data for expenditures on residential housing and education are derived from surveys. these independent variables are constructed to measure shares of housing and education spending by households relative to disposable income. sales prices are used for urban housing estimates, whereas building costs are used for rural areas. table shows results of time series analysis of savings rates as a function of out-of-pocket health expenditure, health insurance payout by insurers, education and housing spending at the household level. adjusted r statistics are all higher than . . the durbin-watson statistic ranged from to . . for urban households, results from model show a statistically significant relationship between health insurance payout and urban household saving. coefficients indicate sensitivity of the savings rate to a % increase in respective independent variables. results from model show that all four variables were statistically significant, at least at the . level. increasing out-of-pocket health spending, health insurance payout, and residential house spending were positively correlated with household saving. education spending was negatively correlated with household saving. for rural households, results were somewhat different. the coefficient for out-of-pocket health expenditure and health insurance payout were both statistically significant. residential home and education spending did not have statistical significance associated with household saving. the disaggregation into periods, to and to (not shown) yielded a much higher urban level of statistical significance in each of the models for the positive coefficient associated with insurer payout in the years the health insurance safety net was implemented. note. significant at *. , **. , and ***. levels. results including household consumption expenditures as a share of gdp are not shown. but for urban households, only the health insurance payout had a positive relationship with household saving ( . ). for rural households, three variables showed statistical significance: out-of-pocket health expenditure, education spending, and rural household consumption/gdp. the coefficients were . , − . , and − . , respectively. out-of-pocket health expenditure and health insurance payout have a positive relation with household precautionary saving for both rural and urban populations. the meaning seems clear in the first instance. households save to account for expected out-of-pocket health expenditure. the second case is less obvious and seems to refute the notion of more health insurance reducing savings and increasing consumption. but perhaps increased health insurance payouts are a proxy for higher prices and increased health spending. health insurance may also release pent-up demand, particularly in poorer rural regions. these effects may predispose households toward more precaution. initial effects of health insurance may differ from the long run, especially if insurance becomes more comprehensive in an environment of relatively stable prices. positive correlation with residential housing expenditure was expected. the chinese save for home purchases to better living standards and as a form of wealth creation. but much of this phenomenon has been in the cities helping to explain differing levels of statistical significance. the negative relation with education was not expected. one explanation is that education spending, an investment in human capital, is seen as a form of savings in this confucian-oriented society, especially in the cities. the payoff will ultimately be increased family income. perhaps savings and education are substitutes. the inclusion of consumption as a share of gdp washes out some of the impact of other independent variables. it was significant at the . level in rural china but only . in urban areas. the only other statistically significant independent variable in cities was insurance payout, and it remained positive. residential building spending came close at . . out-ofpocket health spending remained very significant in rural areas with a positive coefficient. education spending also remained significant and negative. this suggests that although out-ofpocket health expenditures for health and health insurance payout both have important effects on savings rates, policy toward boosting consumption as a share of gdp is also important. per capita disposable income is a central data element in the analysis. disposable income is commonly allocated toward some of the independent variables such as out-of-pocket health expenditures, housing, and education. this raises multicollinearity as a concern. many important allocations of disposable income are not included such as consumer durables and nondurables. and payout of health insurers is not a constituent part of the allocation of disposable income. but to investigate, hysteresis, a notion of dependence on past inputs and output, tolerance and variance inflation factor tests were used. results indicated that multicollinearity may be a problem for the urban model that included education and residential home spending as independent variables. this calls into question quality of the coefficients associated with the independent variables. future research might better identify and address this issue. a second concern is the limited number of observations. we only use data from to . further research using additional data can help establish more robust findings. third, this study only evaluates first-order effects. analysis of second-order effects focusing on rates of change should be considered to develop a more nuanced understanding. breaking the period down into sub-periods does help though. finally, there are concerns about urban health insurance data. before the urban medical insurance schemes were established, civil servants and personnel at public institutions were entitled to publicly funded medical care, and employees from firms were entitled to employer-based coverage. now both are integrated into uebmi. our analysis only uses uebmi data, and there are concerns about accuracy of urban insurance payout data, especially in the early s. transformation of china's health sector is underway. it is a critical component of macroeconomic structural adjustment. but it is subject to path-dependent trajectories. economic and health planners are bound by prevailing organizational and institutional convention. such has been the case in the united states, and an early assessment of american health care in the late s and s is instructive. this work, by the committee on the cost of medical care, recommended substantial organizational change to meet the challenges of the th century. it called for restructuring in favor of more businesslike models of delivery and finance in spite of opposition from the american medical association that preferred to conserve individual and entrepreneurial physicians. the committee's majority report advocated organizational delivery, salaried positions, and sound cost accounting with economically meaningful prices. in short, a case was made for corporatization of medicine. china today faces a myriad of organizational challenges some of which parallel those of the united states in this earlier era. one concern is professional control. it is premised on the notion that authority for delivering care must rest with the professional whose knowledge, skills, and socialization are required. the problem is that such control, constrained by norms and self-interest, may be resistant to change. professional hegemony by physicians is well-established in china and includes senior hospital management positions. this is unlikely to change soon. but it will be more difficult to sustain in increasingly complex environments, and encroachment by other influences can be expected. organizational theorists have a range of traditional concerns, many of which are also issues in chinese health care. for example, proponents of institutional approaches to organization theory argue that managerial behavior is substantially driven by conformance standards. change is difficult to effect and constrained by custom. the well-established role of traditional medicine in china, in spite of only partially proven effectiveness, underscores this. other concerns involve agency relationships, which focus on disparate interests of providers, consumers, and others that can undermine efficiency with under-allocation or over-allocation of resources. overprescribing is one very important example. the power of interest groups is yet another concern, but more amenable to control in a one-party state when economic modernization maintains sufficient priority. an associated issue is a relationship-driven economic activity. the term guanxi describes favored relationships rooted in family, community, or college ties. it is much more entrenched in china than many other countries and can be a source of inefficiency. finally, china is particularly prone to groupthink, control, and conformance standards. the health sector is no exception and organizational change will be challenging. china statistical yearbook world bank china's macroeconomic situation in with predictions and policy recommendations for the next five years more to be done to expand consumption public health insurance and private savings chinese health care: determinants of the system peiping on the march: the eighth congress of the ccp economic planning and policy in communist china first five-year plan for development of the national economy of the people's republic of china in - communique on the results of implementing the first five-year plan patterns of asian communism a rationalized account of its transition and growth the sixth five-year plan of the people's republic of china for economic and social development ( - ) china's entry into world markets. china's sixth and seventh five-year plans china's economic experiment: back from the market the process of china's market transition ( - ): the evolutionary, historical, and comparative perspectives understanding china's growth: past, present, and future legacies and lessons of the " th fiveyear plan privatization and its discontentsthe evolving chinese health care system health care for . billion: an overview of china's health system modernization and health care in contemporary china office of the world health organization representative in china chinese politics under hu jintao. problems of post-communism china's health care sector in transition: resources, demand and reforms the evolution of china's social policies backgrounder: china's th five-year plan political economy realities in the chinese health sector lessons from the east-china's rapidly evolving health care system china's transition phase and long-term development path, efficiency and growth rates why has china succeeded? and why it will continue to do so china: does government health and education spending boost consumption? why are savings rates of urban households in china rising? china's economic rise: history, trends, challenges, and implications for the united states china's rebalancing opens new opportunities for developing asia international financial statistics economic planning in china china's th five-year plan: strategy vs. tactics the effects of medical insurance on durables consumption in rural china an inquiry into the causes of inadequate household consumption in china-an analysis based on provincial data of urban and rural china determinants of china's private consumption: an international perspective economic organization of medicine and the costs of medical care through the lenses of organizational sociology: the role of organizational theory and research in conceptualizing and examining our health care system research strategies for organizational history: a dialogue between historical theory and organization theory alternative perspectives on institutional and market relationships in the u.s. health care sector strategy in an institutional environment organization and management in the midst of societal transformation: the people's republic of china organizational culture and its relationship with hospital performance in public hospitals in china the authors acknowledge in-kind support provided by the shandong university of finance and economics and the center for health management and policy both in jinan, people's republic of china. the authors also appreciate the able assistance of the graduate assistant in china, rong xuejing. the author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. the author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: financial support provided by the university of the pacific in stockton, california. key: cord- - xx xm d authors: feng, zhan-hui; cheng, yong-ran; chen, juan; ye, lan; zhou, meng-yun; wang, ming-wei title: chinese medical personnel against the -ncov date: - - journal: journal of infection doi: . /j.jinf. . . sha: doc_id: cord_uid: xx xm d nan in this journal, zhu et al. recently reported the results of their genomic analysis of multidrug-resistant klebsiella pneumoniae isolates from individual patients before and after colistin treatment highlighting the rapid emergence and multifaceted molecular mechanisms of colistin resistance in k. pneumoniae. this work highlights the therapeutic and public-health challenges of colistinresistance (cr), which is increasingly used as a large resort antibiotic, despite its unattractive toxicity profile and narrow therapeutic window. oral non-absorbed colistin has been proposed as a decontamination strategy in intensive care units and for patients carrying multidrug resistant enterobacterales (mdr-e). , the impact of decolonization strategies in terms of emergence of cr has rarely been monitored because no reliable selective medium existed and cr was not considered a public-health problem. recently, reliable universal culture media have been developed to screen for cr. here, we studied the impact of non-absorbed oral colistin on the emergence of cr in the gut microbiota of patients from the rgnosis-wp randomized controlled trial. thirty-nine subjects colonized with mdr-e were randomized to receive oral colistin sulfate miu times a day + neomycin sulfate mg bid for days followed by a fecal microbiota transplant (fmt) from healthy donors, or no intervention. stool samples were collected on visit v (screening sample), v (after days of oral decontamination and before fmt for the intervention group), v , v and v , respectively - days, - days and - days later. stool samples from donors and subjects from the intervention group and from the control group were available for this work and plated on drigalski plates (control) and superpolymyxin r plates. colony forming units (cfu) counts of all gram-negative rods were determined. isolates growing on superpolymyxin r plates were identified by maldi-tof; cr was confirmed by the culture-based rapid polymyxin np test and mic determined by the microdilution method. the limit of detection was cfu/g of stool. cr-e. coli were sequenced using the illumina hiseq technology. to determine whether cr isolates were present before the intervention, a specific mcr- pcr was performed on patients stool prior to intervention (v ) and on the donor's stool. electroporation of plasmids was performed to localize the gene conferring resistance to colistin and neomycin and molecular typing of the electroporants was performed using pcr based replicon typing (pbrt). ✩ université de paris, iame, inserm, umr- no patient or donor included in the trial carried cr isolates on v . among the patients in the intervention group two ( . %, [ic − ; ], p = . ) carried cr isolates at least at one visit after the intervention ( fig. ) . no cr-enterobacterales was detected in the stools of subjects from the control group. among both subjects with cr-enterobacterales, one carried log cfu/g of hafnia paralvei , a species which is intrinsically resistant to colistin (mic = mg/l), also resistant to neomycin (mic = mg/l) on visit and the other carried log cfu/g and log cfu/g cr-e. coli at visits and , respectively, with a colistin mic at mg/l. relative abundance of cr-e. coli increased between v and v from . % to % of the total enterobacterales population. the cr-e. coli recovered at v and v both belonged to phylogroup c st group and carried the serotype o :h . a plasmid-borne mcr- . gene encoding for cr as well as a aph( )-ia gene conferring resistance to neomycin were identified, both being co-located on the same inchi plasmid. in addition, resistance genes conferring resistance to hygromycin b ( aph( )-ia ), sulfonamides ( sul ), tetracyclines ( tet(a) ) and phenicols ( flor and cata ), all antibiotics used in veterinary medicine, were evidenced. for both subjects, cr strains could not be retrieved in the initial stool of the subject or in the donor's stool. pcr experiments performed with specific primers to detect mcr- gene directly on the pre-therapeutic stool were also negative. to our knowledge, this is the first report of the in-vivo selection of cr-enterobacterales in the gut microbiota of patients after oral decontamination by colistin. the selection of cr strains (a naturally-resistant h. paralvei and a mcr- producing e. coli ), both resistant to colistin and neomycin, may be the result either of the enrichment process by sod of preexisting cr strains that had not been initially detected because of very low abundances, or of an exogenous acquisition, either from other individuals or through fmt. indeed the transmission from fmt of mdr strains from positive donors is a potential risk. despite our efforts to decrease the limit of detection of mcr producers by using a pcr technique directly on the pre-therapeutic stool sample and the donors' stools, we failed to detect the parental strain, either because cr strains were in intestinal niches, the limit of detection remained too high, or the strain was acquired exogenously. however, the mcr- -positive e. coli is likely of animal origin according to its genetic features and its co-resistance profile. indeed, phylogroup st is frequently encountered among avian pathogenic e. coli (apec) and co-resistances to many antibiotics used specifically in veterinary medicine is striking. furthermore, the aph( )-ia gene confers resistance to neomycin and paromomycin, the latter commonly used in cattle and pigs. the selection of the mcr- producer is an illustration of the "one health" problem of resistance: a strain likely to have been selected by veterinary antibiotics among animals ended up in a patient's gut, later enriched by the use of colistin and neomycin as decontaminant. although the small number of subjects is a clear limitation, this observation is a "proof-of-concept" of the risk of selection of cr-enterobacterales after oral colistin treatment and fmt, at a time when colistin is one of the last resort antibiotics to treat mdr-enterobacterales infections. the selection of commensal cr-e. coli is especially worrying, given the pathogenic potential of e. coli and its ability to widely colonize animals and humans. given the controversial results of oral decontamination by colistin, we believe it should only be used with precautions and with thorough monitoring of cr. we read with interest a recent paper in this journal by luzatti and colleagues, who explored the significance of the presence of herpes simplex virus (hsv) dna in lower respiratory tract (lrt) specimens for the diagnosis of hsv pneumonia in immunocompromised patients. the authors underlined the difficulty in gauging the clinical relevance of such a laboratory finding in the absence of histopathological data, as hsv shedding in the lrt may occur in the absence of disease. the interpretation of real-time pcr results for diagnosis of pneumocystis jirovecii (pj) pneumonia (pjp) faces an analogous challenge, since the presence of pj dna in lrt may reflect colonization (carriage) rather than infection. there is limited information on the clinical value of pj real-time pcr in diagnosing pjp in patients with hematological diseases; - this is exceedingly challenging as the sensitivity of direct examination procedures is suboptimal due to low fungal burdens. here, we report on our experience on this matter. a total of episodes of pneumonia occurring in consecutive patients with hematological disorders in which pjp was considered in the differential etiological diagnosis were included. of these, episodes developed in patients undergoing either allogeneic hematopoietic stem cell transplantation-allo-hsct-( n = ) or autologous-hsct ( n = ), and in non-transplant patients (acute leukemia, n = ; lymphoma, n = ; chronic leukemia, n = ; others, n = ). the patients were attended at the hospital clínico universitario-hcu-( n = ) or at the hospital universitario politécnico "la fe" -hlf-( n = ) between june and august . no patients in the cohort tested positive for hiv. this study was approved by the respective hospital ethics committee and informed consent was obtained from all patients. a single specimen per episode was available for diagnosis (bal fluids, n = ; sputa, n = ; ta, n = and bronchial biopsy, n = ). the realcycler pjir kit r (progenie molecular, spain) was used at hcu, and the pneumocystis jirovecii real time pcr detection (certest biotech; zaragoza, spain) was employed at hlf (see footnote in table ). both assays target the large sub-unit of ribosomal (mtlsu) rna gene. preliminary experiments using bal specimens indicated that both assays yield comparable pcr cycle thresholds (c t s) (median, . , range, . - . vs. median . ; range, . - . , respectively; p = . ). all specimens tested negative by direct examination for pj, whereas were positive by real-time pcr (bal, n = ; sputa, n = , and ta, n = ); following stringent clinical, microbiological and imaging criteria ( table ) , pjp was deemed to be the most probable diagnosis in episodes occurring in unique patients. no histopathological confirmation of pjp was available for any patient. pcr c t values inversely correlate with fungal burden in the sample. which is higher in patients with pjp than in colonized individuals. here, overall, pj pcr c t s in specimens from patients with pjp tended to be lower than in pj carriers ( p = . ); when only bal fluid specimens were considered, the difference reached statistical significance (median, . ; range, . - . vs. median . ; range, . - . ; p = . ). this finding is likely related to use of more standardized procedures for bal fluid sampling. receiver operating characteristic (roc) curve analysis showed that a threshold c t value of . in bal specimens displayed a sensitivity of . % ( % ci, . - %) and a specificity of % ( % ci, . - %) for pjp diagnosis. a number of studies have established different c t s cut-offs for that purpose, [ ] [ ] [ ] [ ] . in our view, however, the variability in the performance of different pcr assays and sampling conditions, heterogeneity of patient populations, and in particular the lack of a pj international standard material for pcr result normalization precludes defining a consensus universal threshold nowadays. the absence of anti-pj prophylaxis, treatment with corticosteroids and serum ldh levels ≥ u/l have been shown to be associated with pjp. here, patients not undergoing anti-pj prophylaxis were more likely to display a clinically significant pj pcr result ( table ). in turn, roc curve analysis indicated that a cut-off ldh value ≥ u/l had a sensitivity of . % (ci %, . - %) and specificity of % ( % ci, . - . %) for pjp diagnosis. in univariate regression logistic models, serum ldh values ≥ u/l were associated with a clinically significant positive pcr pj result (or, . ; % ci, . - . ; p = . ). in contrast, corticosteroid use within the month before sampling was not different between the probability of pneumocystis jirovecii (pj) pneumonia (pjp) for each patient was retrospectively evaluated by an expert committee including infectious diseases and microbiology specialists at both centers, on the basis of (i) documented pj presence in respiratory specimens by microscopy; (ii) compatibility of clinical signs and symptoms (at least of the following: subtle onset of progressive dyspnea, pyrexia, nonproductive cough, hypoxaemia and chest pain), (iii) compatible (suggestive) radiological findings (chest radiograph and/or high-resolution computed tomographic scan detection of interstitial opacities and/or diffuse infiltration infiltrates); (iv) complete resolution of symptoms after a full course of anti-pjp treatment; (v) absence of alternative diagnosis. the efficacy of therapy was assessed on a daily basis. pjp was ruled out if real-time pcr for pj tested negative, or if clinical recovery occurred in the absence of pj-targeted antimicrobial therapy. pj colonization (carriage) was the most likely possibility when patients did not meet the above criteria and an alternate diagnosis was made. b frequencies were compared using the χ test (fisher exact test) for categorical variables. two-sided exact p values were reported and p values ≤ . were considered statistically significant. the data were analyzed with the spss (version . ) statistical package. c respiratory tract specimens were obtained following conventional procedures. specimens were examined for presence of ascus or trophic forms of pj by microscopy following blue toluidine, calcofluor white or grocott's methenamine silver staining. cytospin preparations were prepared from bal specimens for direct examination. sputa and ta samples were mixed v/v with sputasol (oxoid, uk) and vortexed for min. all samples were centrifuged at g for min, and the pellets were resuspended / in . % nacl for further processing. for real-time pcr, dna was extracted from μl of specimens using the qiaamp dna blood mini kit (qiagen, hilden, germany) on either qia symphony or ez- platforms (qiagen), following the manufacturer's instructions. at hcu, a commercially-available real-time pcr assay previously evaluated by others, the realcycler pjir kit r (progenie molecular, spain), which targets the mitochondrial large sub-unit of ribosomal (mtlsu) rna gene, was used according to the manufacturer's instructions ( http://www.progenie-molecular.com/pjir-u-in.pdf ). at hlf, the commercially-available pneumocystis jirovecii real time pcr detection. (certest biotech; zaragoza, spain), which also targets the large sub-unit of ribosomal (mtlsu) rna gene, was employed following the manufacturer instructions ( https://www.certest. es/wpontent/uploads/ / /viasure _ real _ time _ pcr _ pneumocystis _ jirovecii _ sp .pdf ). at both centers pcr were performed in the applied biosystems fast real-time pcr platform (applied biosystems, ca, usa). pcr results were reported as positive or negative. for positive samples, threshold cycle (c t ) values were also recorded. no standard curve was generated with a positive control for quantitative estimations. d antimicrobial prophylaxis for pjp was performed with trimethoprim-sulfamethoxazole (tmp/smx), one double-strength tablet ( mg tmp/ mg smx) given (in allogeneic hsct patients) or times a week with oral folic acid ( , ) . patients with suspicion of pjp according to the attending physician were treated with tmp/smx - mg/kg (tmp) - mg/kg (smx) per day for - weeks. e in all these cases, death was attributable to pjp. patients with clinically significant pj detection and pj carriers ( table ) . detection or recovery of other microbial agents (one or more) was documented in of the specimens testing positive by pj pcr ( table ). in line with a previous report, this microbiological finding was significantly less frequent ( p = . ) in specimens from patients with pjp than in colonized patients; in fact, microbial co-detection was inversely associated with pjp in univariate logistic regression models (or, . ; % ci, . - . ; p = . ). strengths of the current study are the following: (i) clinical categorization of pjp was based upon stringent criteria defined by a multidisciplinary team; (ii) only hematological patients were included; (iii) a comprehensive routine investigation of microbial causes of pneumonia other than pj was conducted; (iv) the experience of two centers was collected. in addition to its retrospective nature, our study also has some limitations: (i) we cannot completely rule out that some patients categorized as being pj carriers did in fact have pjp, as most of these patients received full courses of tmp/smx in combination with antimicrobials targeting other microbial agents. the lack of standardized criteria for pjp diagnosis makes clinical misclassification of patients a potential drawback in studies such as ours, particularly when no positive microscopy or histopathology findings are available; (ii) although we evaluated bal, bronchoalveolar lavage; pjp, pneumocysis jirovecii pneumonia; ta, tracheal aspirate. a as per our routine protocol, all specimens were examined by gram and acid-fast bacilli stain. samples were also examined for presence of respiratory viruses (rvs) using either the luminex xtag rvp fast assay (luminex molecular diagnostics, austin, tx,usa) at hcu, or the clart® pneumovir assay (genomica, coslada, spain) at both centers, as previously reported. semiquantitative (sputa) and quantitative (bal and ta) cultures for bacteria were performed on conventional media: bacterial loads > cfu/ml or > cfu/ml were deemed to be clinically relevant on bal fluids and ta samples, respectively. specimens were cultured on bcye-alpha agar, bd (becton dickinson) mgit® ( mycobacteria growth indicator tube)/lowenstein-jensen agar slants and sabouraud agar for recovery of legionella pneumophila, mycobacterium spp., and other fungal organisms, respectively. the platelia tm aspergillus ag kit (bio-rad, hercules, ca, usa) was used for quantitation of aspergillus spp. galactomannan in bal fluid and serum specimens. all bal fluid specimens underwent cytomegalovirus (cmv) pcr testing using the realtime cmv pcr assay (abbott molecular) at hcu or the cmv r-gene® assay (biomerieux) at hlf, as previously reported. over patients, only presumptively had pjp; (iii) two different commercially-available pcr assays were used across centers. nevertheless, we found them to yield rather comparable c t s. in summary, we found that a positive pj pcr result in respiratory specimens from transplant and non-transplant hematological patients with pneumonia frequently reflects colonization rather than infection; pcr c t values in bal fluids, serum ldh levels and lack of co-detection of other microorganisms potentially involved may be helpful in clinical categorization in the absence of positive by pj microcopy results. we have no conflict of interest to declare. dear editor , poller et al., in this journal, provided a useful consensus for use of personal protective equipment for managing high consequence infectious disease . although this was driven largely by recent ebola virus disease emergencies, we should remind your readers of the continuing problem of lassa fever (lf) in west africa. lf is a febrile infectious disease caused by lassa virus. the clinical presentation of the disease is nonspecific and includes fever, fatigue, hemorrhage, gastrointestinal symptoms, respiratory symptoms, and neurological symptoms . the observed case fatality rate among patients hospitalized with severe lf is - % , . the disease is mainly spread to humans through contamination with the urine or faeces of infected rats . human-to-human transmission can occur through contact with the body fluids of infected per-sons. therefore, health care workers are at high risk for infection when the standard precautions for infection prevention and control including appropriate personal protective equipment are inadequate . it is estimated that there are approximately , lf cases annually, resulting in approximately deaths in west african countries . in , nigeria had a large lf outbreak, and we previously reported epidemiological characteristics of the outbreak, analyzing data collected between january and may . however, information on laboratory-negative suspected cases was not enough to conduct a case-control study to fully determine the risk factors and clinical characteristics of the disease. nigeria had a lf outbreak in as well. here we report the epidemiological and clinical characteristics of the outbreak including case-control analysis against laboratory-negative suspected cases using data collected between st january and th october . from january to december , there were suspected cases, including laboratory-confirmed lf cases. in , there were suspected cases reported by th october, including laboratory-confirmed lf cases. details on the case definition, laboratory test, surveillance, and data collection have been described previously. of the confirmed lf cases, there were fatalities (case fatality rate, . %) in and fatalities (case fatality rate, . %) in . the number of laboratory-confirmed lf cases and positivity rate peaked in the dry season (january-march) in both and ( fig. (a) ). the largest number of laboratory-confirmed lf cases were reported from the neighboring edo and ondo states in both and ( fig. (b) ). there were laboratory-confirmed lf cases in states such as kebbi and zamfara that had no reported cases previously, in . during the study period, the detailed demographic and clinical information was collected for laboratory-confirmed lf cases (of cases, . %) and laboratory-negative suspected cases (of cases, . %). chi-square tests were conducted to compare the distribution of age, sex, and each symptom between the laboratory-confirmed lf cases and laboratory-negative suspected cases ( table ). the proportion of children was significantly lower in laboratory-confirmed lf cases compared with that in laboratory-negative suspected cases. the proportion of males was significantly higher in laboratory-confirmed lf cases than that in laboratory-negative suspected cases. fever was the most prevalent symptom in both laboratoryconfirmed lf cases and laboratory-negative suspected cases, followed by headache ( table ) . gastrointestinal symptoms, such as abdominal pain, vomiting, and diarrhea, were observed in more than % of laboratory-confirmed lf cases, whereas hemorrhaging was observed in . % of laboratory-confirmed lf cases. while the prevalence of face/neck edema was low even in laboratoryconfirmed lf cases ( . %), nonetheless, the odds ratio of having face/neck edema was . times high for laboratory-confirmed lf cases. we here reported the lf outbreak in - largest recorded in history. while previous studies have focused on laboratory-confirmed lf cases and mainly compared fatal cases and survived cases, , , our observation revealed the difference between laboratory-confirmed lf cases and laboratory-negative suspected cases. the age and sex distribution differed significantly between laboratory-confirmed lf cases and laboratory-negative suspected cases. fever, headache, and gastrointestinal symptoms were the most common symptoms in laboratory-confirmed lf cases, which are similar to those reported previously. , however, these symptoms were also prevalent in laboratory-negative suspected cases. clinical guidelines for lf state that edema in the face and neck is a specific sign of the disease. the present study found that the symptom had a significantly high odds ratio for confirmed lf although the prevalence of this symptom was low. unfortunately, we did not determine the differential diagnosis for the laboratory-negative suspected cases. laboratory tests for the differential diagnoses are now underway for the lf-negative samples collected during the outbreak. the results would provide us further insight for better clinical management of patients with febrile illnesses in lf-endemic areas. in addition to the standard precautions for infection prevention and control including appropriate personal protective equipment pointed out by poller et al., it is important to know epidemiological and clinical characteristics of high consequence infectious diseases such as lf. that would help healthcare workers and public health officers increase an index of suspicion of the diseases, further leading to better clinical management and surveillance. the authors have declared that no conflicts of interest exist. this work was partially supported by the leading initiative for excellent young researchers from the ministry of education , culture, sport, science & technology of japan and the japan society for the promotion of science (grant number, ). the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. these authors contributed equally to this article. accepted december available online january https://doi.org/ . /j.jinf. . . © the british infection association. published by elsevier ltd. all rights reserved. recently, several studies in this journal have demonstrated the threat of animal-derived viruses to humans. [ ] [ ] [ ] since , an increase in human pseudorabies virus (prv) infection cases has been reported in china, indicating a new animal-derived virus threat to human health. porcine pseudorabies (pr), also known as aujeszky's disease, is one of the most economically important viral diseases in pigs globally. its causative agent is prv, which is classified into the genus varicellovirus of subfamily alphaherpesvirinae , family herpesviridae . prv is almost always fatal in newborn piglets, is frequently accompanied by neurological symptoms, and may cause abortions and/or stillbirths in pregnant sows. prv primarily infects members of the suidae family and can also infect other domestic and wild mammals, including horses, cattle, sheep, goats, dogs, cats, etc. currently, vaccination is the most effective strategy for pr prevention and control in pigs worldwide. in china, prv infections in pigs were first recorded in . in the s, an inactivated vaccine consisting of the bartha-k vaccine strain was imported into china. since then, this vaccine has been widely used in pig vaccination for pr prevention and control. before , no large pr outbreaks were reported in pigs in china. however, after late , novel prv wild-type variants emerged in nearly all regions of china and affected a number of swine herds vaccinated regularly with the bartha-k vaccine, resulting in significant economic losses. subsequent animal experiments indicated that the bartha-k vaccine could not provide complete protection for pigs against a challenge with novel prv wild-type variants in china. for control and eradication of pr, the disease was listed in the "mid-and long-term animal disease prevention and control program in china ( - )" by the chinese government, with the aim of eliminating pr in china by ( http://www.gov.cn/zwgk/ - / /content _ .htm ). however, vaccination for prv is still voluntary and not required in china. a nationwide epidemiological investigation in demonstrated a high prevalence of . % of prv among swine herds in china. humans were previously regarded as refractory for prv infection, although serological prv antibody positivity was found in three cases. in , the first human prv infection case with direct molecular evidence was reported in china (case , table ). in this case, the eyes of a -year-old woman were directly exposed to sewage on a hog farm. in the following two weeks, symptoms of fever, headache, coma, and endophthalmitis were observed in the patient. next-generation sequencing (ngs) indicated that prv dna was detected in her vitreous humor samples but not in her cerebrospinal fluid (csf). after surgery, the patient was discharged, but her vision remained impaired. in a subsequent study, zhao et al. table clinical characteristics and other information on the twelve human prv infection cases in china. analyzed csf samples from four patients with encephalitis of unknown etiology using ngs (cases - , table ) and found molecular evidence of prv infection. in addition, retinitis and blindness was observed in two cases (cases , , table ), and the patient in case died. the occupation of the four patients was all associated with pork production/sale/cooking. in , six other human prv infection cases involving encephalitis were reported in china, and all patients were pork/pig handlers or veterinarians. [ ] [ ] [ ] it was noted that all patients still suffered from various sequelae after discharge, except for in one case where the patient died. increasing reports on human prv infection cases in china have recently indicated that prv poses a significant threat to public health in china, especially in people in close contact with sick pigs and/or related pork products/contaminants. to reduce the risk of prv infection in susceptible workers, it is necessary to promulgate relevant policies by the chinese government to promote pr vaccine development to protect pigs from infection with novel prv wild-type variants currently circulating in china. in addition, relevant policies should be updated by the chinese government to monitor vaccination status and virus variation in pigs nationwide. moreover, it seems that prv can infect humans via injury to the skin or eyes. until now, no effective drugs to prevent the progression of the disease caused by prv infection have been reported. therefore, it is necessary to improve biosafety and self-protection awareness in susceptible populations that have contact with sick pigs and work in jobs related to handling pork products/contaminants. promoting drug development for curing prv-related disease in infected patients may also help reduce the currently increasing threat of prv to human health in china. all authors declare that they have no competing interests. dear editor, the emergence and spread of gram-negative bacteria, for example, klebsiella pneumoniae , co-producing carbapenemases and mobilized colistin resistance ( mcr ) genes limit our choice for treating multidrug-resistant infections, posing significant threats to public health. herein, we reported the discovery of mcr- gene in k. pneumoniae strains isolated from patients in eight european countries, including belgium ( n = ), denmark ( n = ), montenegro ( n = ), poland ( n = ), romania ( n = ), serbia ( n = ), slovenia ( n = ), and spain ( n = ). notably, the co-existence of mcr- and the carbapenemase-encoding genes, ndm- , vim- , and oxa- were confirmed in k. pneumoniae isolates of human origin. phylogenetic analysis suggested that mcr- -carrying k. pneumoniae isolates, including carbapenem-resistant and five susceptible k. pneumoniae strains, show a highly geographically clustered pattern. genetic environment analysis revealed the presence of insertion element is , is or a cupin fold metalloprotein, wbuc, in the mcr- flanking. taken together, these findings indicated that mcr- has existed for a long time and already spread among crkp isolates of human origin in europe since , further increasing the significant threat of public health through either the nosocomial spread or environmental routes. the mobilized colistin resistance ( mcr ) gene mcr- was detected in human gut microbiomes, which has been disseminating across three continents, including asia, europe and america, recently published in the journal of infection. the rapid increase in carbapenem resistance among gram-negative bacteria worldwide has greatly compromised the efficacy of carbapenem antibiotics, which has gotten renewed attention to the importance of polymyxin antibiotics for multidrug-resistant (mdr) infections. recently, sophia david and colleagues reported the epidemic of carbapenem-resistant klebsiella pneumoniae (crkp) in europe, which raised concern that mobile carbapenemase resistance determinants were widely spread in european hospital settings, and inter-hospital spread is far more frequent within, rather than between, countries. however, limited information regarding the co-occurrence of carbapenemases and mcr genes in the klebsiella pneumoniae ( k. pneumoniae ) isolates have been provided. plasmid-mediated resistance genes mcr as well as tet (x /x ) have been widespread in bacterial species of animal, human, and environment origin as well as human and animal gut microbiomes worldwide, where is a huge arg reservoir with a high horizontal gene transfer possibility. , - several studies - illustrated that the newly described mcr- has spread beyond the united states into europe and asia, and into other enterobacteriaceae species. of clinical concern is the inevitable spread of a plasmid harboring the mcr- gene into a crkp isolate, which has been listed by the world health organization as a critical priority antibiotic-resistant bacterial pathogen for which new antibiotics are urgently needed. in response to this potential clinical problem, we download > k. pneumoniae genomes isolated from hospitals in european countries and the , complete bacterial genome sequence (accessed july ), and explored the distribution of plasmid-mediated resistance genes mcr and tet (x /x ). we are surprised to find that the complete mcr- gene (nucleotide = %) was present in k. pneumoniae isolates of k. pneumoniae strains from belgium ( n = ), denmark ( n = ), montenegro ( n = ), poland ( n = ), romania ( n = ), serbia ( n = ), slovenia ( n = ), and spain ( n = ) (table s ). additionally, of the k. pneumoniae isolates of human origin were crkp strains and only five were carbapenem-susceptive isolates (table s ). as reported, these mcr- -harbouring strains were isolated from patients in europe between and . these results suggest that mcr- gene might have been presented in europe for a long time and already spread to the crkp isolates, which is a major cause of both hospital-and community-acquired infections. to further analyze these mcr- -positive k. pneumoniae isolates, the resistome of the draft genome was analyzed using the comprehensive antibiotic resistance database. interestingly, the mcr- gene was co-existed with various carbapenemase-encoding genes: in eleven isolates with ndm- , eight with vim- , and two with oxa- ( fig. (a) ). it should be noted that the mcr- -and ndm- -carrying isolates were distributed in denmark ( n = ), montenegro ( n = ), romania ( n = ), and serbia ( n = ), as well as several other beta-lactam resistance determinants (for example, tem- , cmy- , oxa- and shv- ) ( fig. (a) and table s ). moreover, the mcr- -and vim- -harbouring isolates were dominant in spain ( n = ) and slovenia ( n = ), as well as two beta-lactamase-encoding genes (non-carbapenemases) (ctx-m- and shv- ) ( fig. (a) and table s ). it is worrying that a crkp isolate from spain in was carrying mcr- , vim- , and oxa- genes simultaneously. the presence of mcr- in crkp isolates from patients is of critical importance as mcr- could be present in hospital-borne outbreaks cre strains in the future. from whole-genome shotgun (wgs) data of the mcr- -positive k. pneumoniae isolates, sequences types (sts) were extracted and assigned to nine different types, i.e. , , , , , , , , , and ( fig. (a) ). phylogenetic analysis suggested that mcr- -carrying k. pneumoniae isolates show a highly geographical clustering pattern ( fig. (a) ). isolates from patients in the same hospital were clustered into one clade, for example, in spain and montenegro. overall, the k. pneumoniae isolates from different countries were genetically diverse, suggesting that the mcr- -positive k. pneumoniae isolates were also genetically diverse and that mcr- could disseminate among different k. pneumoniae isolates, mainly by nosocomial transmission. nowadays, all known mcr genes have been detected in various gram-negative bacterial species, whereas a small number of studies have shown the presence of mcr- , mcr- , mcr- , and mcr- in k. pneumoniae isolates from animal and human origin at relatively low detection rate. - the presence of mcr- in the crkp isolates indicated that this novel mcr gene may already be widely spread among k. pneumoniae isolates of human origin in europe. we subsequently searched mcr- gene in , complete bacterial genome sequence and ncbi-nr database ( october ) in the ncbi, to fully understand the prevalence of mcr- gene in klebsiella species isolates. interestingly, the mcr- gene (identity > % and % query coverage) was present in various bacterial genomes, including three klebsiella species isolates consisting of k. pneumoniae ( n = ), k. quasipneumoniae ( n = ), and k. oxytoca ( n = ) (table s ) . therefore, further studies focusing on the epidemiology and transmission mechanism of mcr genes, in particular mcr- in klebsiella species of human origin are warranted to better understand the public health threat of emergence of antibiotic resistance among clinical k. pneumoniae . contigs carrying mcr- in k. pneumoniae isolates could be classified into two groups (for example, gca_ . and gca_ . ) (table s ) . genetic environments analysis indicated that the presence of insertion element is and wbuc (a cupin fold metalloprotein), in the mcr- (gca_ . , ∼ kb) upstream and downstream flanking, respectively, similar to (identity > %) the plasmid sequences of pme- a, pctxm _ , and pmrvim , and contigs from of e. coli isolate a and nz_naan from salmonella ( fig. (b) ). additionally, mcr- in another contig ∼ . kb was in the upstream of two insertion element is and is , as well as a beta-lactamase-encoding resistance gene ctx-m- , which similar to the plasmid sequence of pmrvim . we did not detect the downstream regulatory genes (qsec and qseb) found in the isolates that harbor mcr- . , moreover, we were unable to determine whether a complete is element is upstream due to a short mcr- -bearing contig that is available for comparison ( fig. (b) ). therefore, a long-read sequencing coupled with a hybrid assembly method is needed to fully evaluate and monitor the transfer and development of args, especially mcr- among crkp isolates. although two unique plasmid-mediated tigecycline resistance genes firstly discovered in bacteria of animal origin in china and subsequently identified in many bacterial isolates of human, animal and environment origin, including klebsiella species, as well as human and animal gut microbiomes, , , none of them was detected in the k. pneumoniae strains in europe. in summary, we reported the discovery of mcr- gene in clinical k. pneumoniae strains of human origin in eight european countries. importantly, the mcr- gene was co-existed with different carbapenemase-encoding genes in the same strains. the spread of mcr- , ndm- , vim- , and oxa- and other beta-lactam resistance determinants (non-carbapenemase) carrying by crkp appears likely to be by plasmid dissemination, as the genes identified in isolates belonging to a diverse set of sts distributed in different hospitals in europe. it is noteworthy that all these mcr- -positive crkp strains were isolated between and , highlighting an earlier presence of mcr- among crkp around the world than previously known. these findings raise the likelihood of ongoing undetected mcr- gene spread among cre strains. therefore, further study is urgently needed to understand the prevalence and dissemination of mcr- , especially in cre and crkp strains, and effective measures should be taken to control its spread. g.f.g. designed the study. y.n.w. and f.l. collected and downloaded the datasets. y.n.w., f.l., y.f.h., b.l.z., g.p.z., and g.f.g. analyzed and interpreted the data. y.n.w. and g.f.g. wrote the draft of the manuscript. all authors discussed, reviewed and approved the final report. supplementary information is available for this paper. correspondence and requests for materials should be addressed to g.f.g. the authors declare no competing interests. the interesting systematic review by amin-chowdhury and colleagues provides information about outbreaks of severe pneumococcal disease (spd) in closed settings that occurred in the conjugate vaccines era . it shows that vaccine-type spd outbreaks are still occurring and it highlights the lack of consensus on how to manage such outbreaks. in the following, we will describe how we managed a recent outbreak of spd in norway. in march , møre and romsdal hospital trust notified the norwegian institute of public health (niph) about a cluster of spd amongst men working in shipyards in møre and romsdal county. serotype data from niph were available for nine of the cases -all were serotype . the majority of cases had been working at one specific shipyard. municipal medical officers (mmo), the norwegian labour inspection authority (nlia), and niph formed a multidisciplinary outbreak team to investigate and control the outbreak. we formed specific case definitions: each case had to have resided in møre and romsdal county in the period from . january onwards and: confirmed : had invasive pneumococcal disease (ipd) with serotype isolated from a normally sterile site. probable : worked at the specific shipyard and had a clinical presentation compatible with lower respiratory tract infection or ipd, but without microbiological confirmation or serotype isolated from a non-sterile medium (e.g. nasopharyngeal swab or sputum culture). we identified cases, ten confirmed and ten probable in the period between . january and . april ( fig. ). all available isolates were serotype ( confirmed, probable) and were susceptible to penicillin. fifteen isolates were sequence type (st) , while two were a single locus variant of , st , . all cases were men between and years, with a mean age of years. fifteen were hospitalized. four were norwegian citizens, the remaining came from other european countries. seven cases smoked. one case had an underlying medical risk condition. immunization history against pneumococci were unknown for all. the cases had several professions; mostly related to interior outfitting and metal welding. approximately individuals worked at the shipyard in the time period. many of them lived in temporary accommodation. at an on-site inspection of the shipyard, nlia observed a polluted atmospheric work environment and little use of personal protective equipment. several measures were put in place to control the outbreak, including information and advice to raise symptom awareness and to reinforce hand and respiratory hygiene, vaccination and occupational corrections. local medical clinics and hospital were alerted about the outbreak and advised to have a low threshold to admit and treat suspected cases. mmo held information meetings with shift leaders, and written information about spd in several languages was distributed to workers to increase spd awareness. intensified hygiene measures were implemented at the ship yard and housing quarters. nlia ordered immediate occupational corrections related to controlling the atmospheric work environment. niph recommended vaccination with the -valent conjugate vaccine (pcv ) to interrupt transmission and prevent disease. both the pcv and the -valent polysaccharide vaccine provide protection against serotype , but pcv was preferred as this may also affect colonization. as several work tasks were conducted in parallel process in confined spaces with suboptimal ventilation, we were unable to identify a single target group for vaccination. hence, the shipyard offered vaccination to all workers. occupational health service promptly vaccinated all workers during a four-day period. contrary to the majority of studies included in the systematic review, niph did not recommend chemoprophylaxis. as the workers were otherwise healthy (i.e. no high risk group like old age, immunocompromising conditions etc.), and since it was impossible to target a specific group of workers, niph deemed it undesirable to distribute antibiotics to asymptomatic workers, with the possibility of inducing antimicrobial resistance and possible side effects. due to high turnover of personnel it was not possible to calculate an attack rate. we did not find any new cases after control measures were implemented. no deaths have been reported in relation to the outbreak. this outbreak closely resembles one of the outbreaks described in the systematic review; between april and june , an outbreak with serotype , st occurred at a shipyard in belfast . we are also aware of an outbreak this fall, , at a shipyard in finland with serotype (st ), and f . although welders are a known risk group for spd, in all these three outbreaks, people who worked closely alongside welders were also infected. in addition to exposure to welding fumes, the crammed and poorly ventilated working conditions, and possibly housing conditions, may have increased the risk of developing spd and facilitated the transmission of pneumococci in this closed setting. overall, this norwegian outbreak extends the knowledge about how to manage and control outbreaks of spd in closed settings. none. in this journal brunet and colleagues discussed reactivation of latent infections in the context of chronic disease, solid organ transplantation or long-term immunosuppressive treatment. we recently observed the reactivation of leishmania infection in a -year-old patient receiving methotrexate for psoriasis, who was diagnosed with visceral leishmaniasis (vl) showing a mucocutaneous involvement. we analyzed the epidemiologic and clinical characteristics of all cases of leishmaniasis in patients with psoriasis found through a review of the literature. our patient was admitted into the infectious disease unit of paolo giaccone hospital, in palermo, with a painless and ulcerated lesion onto the oral mucosa ( fig. a ) , two nodular ulcerated lesions on the right knee and another one on instep of the right foot appeared one month before ( fig. b ) . the patient did not travel outside italy during the last year. he had been suffering from lowgrade fever in the last month. considering the above findings leishmaniasis was suspected and a needle aspiration of oral and cutaneous lesions was arranged in order to perform microscopy and leishmania-pcr, which were positive for leishmania. laboratory tests exhibited: wbc /mmc, hb . g/dl, c reactive protein, . mg/l; positive serology for leishmania (igg / ) and positive leishmania-pcr test on peripheral blood. abdominal us examination revealed splenomegaly ( cm); methotrexate was suspended and liposomal amphotericin b, mg/kg per day for days, followed by two further administrations two weeks later was started. cutaneous and mucosal lesions improved at the end of the first days of therapy and completely vanished after two further administrations, days from the beginning of treatment. leishmania-pcr on peripheral blood after days of therapy was negative. table shows the literature data about characteristics, therapy and outcome of patients with psoriasis and leishmaniasis. leishmaniasis is a vector-born chronic infectious disease caused by protozoa of the genus leishmania and transmitted to humans by the bite of phlebotomine sandflies. in europe, the mediterranean countries are the most affected areas. leishmania parasite establishes chronic intracellular parasitism, survives for an infected person's lifetime and, in the event of major immune deficiency, may be reactivated from sites of latency. leishmaniasis can present with a spectrum of clinical manifestations and three patterns of infection are described: cutaneous (cl), mucosal or mucocutaneous (ml or mcl) and visceral leishmaniasis (vl). the infecting species of leishmania is very important in determining the clinical manifestations and the host immune response is crucial in determining the clinical outcome of infection . today, non-hiv related immunosuppressive conditions are becoming increasingly prevalent, mainly because of better medical care of patients with chronic illnesses and the therapeutic use of immunosuppressive drugs. in the field of rheumatology, leishmaniasis has been reported in association with the use of various immunosuppressive drugs. the introduction of tumor necrosis factor-alpha (tnf-α) antagonist drugs has received much attention recently and several cases of vl have been reported in rheumatic patients who do anti-tnf α drugs. psoriasis is a chronic inflammatory autoimmune disease affecting - % of the world's population and characterized by an aberrant hyper-proliferation of keratinocytes. the pathogenesis of psoriasis is complex. genetic susceptibility, environmental triggering factors and an over-reaction of local innate immune response initiate inflammation. subsequent involvement of adaptive immune response with production of th cytokines, chemokines and growth factors lead to epidermal hyperplasia. recently, a functional role of interleukin- -producing t helper cells (th ) in psoriasis has been suggested by their reduction during successful anti-tnf treatment. it is also known that th lymphocytes play an essential role in protecting against intracellular protozoa and in the successful clearance of leishmania by strengthening the th response. in view of this, it could be argued that psoriasis may represent a protective factor for leishmania infection. indeed, in our review we did not found any case of leishmaniasis in psoriatic subjects who were not under immunosuppressive therapies. biological agents, which are powerful immunosuppressive drugs, have been more and more used in rheumatic patients and leishmania infections have been reported among anti-tnf-agents users. recently maritati et al. found higher prevalence of subclinical leishmaniasis in patients with inflammatory rheumatic diseases receiving biological drugs than those treated with other immunosuppressive drugs. however, leishmaniasis has also been reported in psoriatic patients not receiving biological drugs, as occurred to our patient ( table ) . diagnosis of cl in psoriatic patients is challenging, as it mimics many other infections or a flare-up of psoriasis itself that can lead to ineffective and harmful changes of therapy. immunosuppressive therapies cause atypical manifestations of leishmaniasis with large lesions spread over large cutaneous areas and associated to a possible mucosal involvement. ml by l. infantum is very rare and only sporadically described in patients receiving powerful immunosuppressive therapies or in hiv-coinfected patients. mcl is mostly observed in latin america where l. braziliensis accounts for most cases, but l. panamensis, l. guyanensis, and l. amazonensis have also been implicated. only rarely cutaneous lesions extend to areas of skin distant from the mucosa involved, as in our case in which two lesions on the foot and knee were associated with the oral lesion. in the context of impaired immunity, it is also advisable to rule out vl by pcr-leismania on peripheral blood so as to establish the most appropriate therapy: intralesional or intravenous. finally, there is no agreement on appropriate screening for leishmaniasis before immunosuppressive treatments and on the strategy to be followed after the diagnosis of leishmaniasis in rheumatic patients taking immunosuppressive drugs. molecular methods are highly sensitive and specific tools for the diagnosis of visceral leishmaniasis and a screening with leishmania-pcr in immunosuppressed patients living in endemic areas could be useful to identify patients at highest risk of reactivation. specific leishmaniasis treatment followed by suspension of the immunosuppressive therapy was adopted by most of the authors. overall even if the treatment response is not as good as seen in the immunocompetent population, our review reports a good outcome in all cases and patients remained relapse-free without maintenance therapy and despite the ongoing use of immunosuppressive medication. in conclusion physicians must be alert to the possibility of development of leishmaniasis in immunosuppressed rheumatic patients. adequate screening for vl should be incorporated into the list of baseline studies to carry out before initiating biologic therapies, at least in endemic areas. the authors declare that there is no conflict of interest. as demonstrated in several studies in journal of infection , herpesviruses pose an increasing threat to human health. [ ] [ ] [ ] according to international committee on taxonomy of viruses (ictv), equine herpesviruses (ehvs) belong to the family herpesviridae . until now, a total of ehv species types have been determined in equines, viz. ehv -ehv . among them, ehv and ehv are the most relevant herpesviruses affecting equines. both ehv and ehv infection are associated with upper respiratory tract disease, but only ehv infection could cause abortion and myeloencephalitis. ehv and ehv are prevalent in equines on all continents and have considerable economic impact on the horse industry. in china, the number of equines is very large, reaching to be ∼ . million in ( http://www.stats.gov.cn/tjsj/zxfb/ ). ehv infection in equines was first reported in china in , and the epidemiological investigation since then indicated ehv was prevalent in the equine population in all the studied provinces in mainland china, with a seroprevalence ranging % − %. [ ] [ ] [ ] vaccination is commonly used to prevent and control ehv. however, china has not developed a commercially available ehv vaccine so far. ehv vaccine has a limited market application potential in china currently. due to the lack of relevant knowledge on ehv, most of the chinese horse owners always erroneously identified it as other common pathogen of equine respiratory diseases, and didn't realize its potential threat to equine health and reproduction. although the number of equines in china is large, most of them are labor/farming horses. to the best of our knowledge, even for racehorses, vaccination with ehv vaccine has not been performed in mainland china. considering the wide distribution and high prevalence of ehv in china, it is urgently to popularize knowledge on ehv in horse owners and promote market application prospects of ehv vaccine. in china, few veterinary researchers are currently investigating equine virus, including ehv. this is mainly caused by the change of equines' historical role. in the last century, a great number of equines were used for military in china. however, there is only one military equine farm in mainland china at present. considering a more important economic role of other domestic animals (e.g., pigs, chickens, and cattle) compared with equines, investigating equine virus (including ehv) is not a priority in the related guide policies issued by the chinese government. though epidemiological studies on ehv in china are limited, it still could be concluded that epidemic status of ehv is very complicated in china, which increases the difficulty in ehv vaccine development. in most provinces, ehv and ehv were co-circulating in equines with a high seroprevalence. until now, a total of ehv strains have been isolated from tissue samples of aborted equine fetuses ( from farming horses in northeast china in , from asian wild horses in western china in , from farming horses in western china in ). , in addition, a novel ehv strain was isolated from one horse with serious respiratory disease in northern china in . recently, our laboratory firstly determined the molecule evinces for ehv and ehv in racehorses in sothern china (data not shown). however, a more large-scale and surveillance of ehv in equines is necessary to fully understand epidemic status of ehv in china, which could establish a foundation for updating the composition of ehv vaccine developed in china in future. in other countries, much effort has been made to develop ehv vaccine, and modified-live and inactivated virus vaccines have been registered for sale. before an ehv vaccine is developed successfully in china by itself, it is necessary to vaccinate the susceptible equine population with an ehv vaccine commercially available from other countries to prevent and control ehv in china. however, a well-designed case-control animal challenge study still needs to estimate the protective efficacy of different vaccines against the field prevalent ehv strains in china. all authors declare that they have no competing interests. a recent review article on the treatment of hepatitis c with directly-acting antiviral (daa) drugs, makes numerous recommendations for baseline drug resistance testing. in our local practice, we have been performing baseline drug resistance testing for some years now, prior to the publication of these guidelines. we present a recent retrospective hcv kinetics analysis of these patients' changing viral loads in response to daa therapy below. such studies have been used previously to compare viral suppressive responses in different hcv genotypes and treatment regimens. , the patients were a mixture of treatment-naive and treatment-experienced (including with interferon-based, ns protease inhibitor-based and daa-based regimens) cases. the current standard of care for hepatitis (hcv) patients is a combination of direct acting antivirals (daas), for which there are three different hcv viral protein targets (ns , ns a and ns b). table ns , ns a, ns b resistance associated substitutions (ras), by hcv genotype, found in this patient cohort at baseline drug resistance testing (viral sequencing performed at imperial college, london, uk). the patients included a mixture of treatment-naïve and treatment experienced (i.e. interferon-based, ns protease inhibitor-based and more recent daa-based regimens) cases. resistance associated substitution (ras) by hcv genotype treatment with daas cure the vast majority of hcv-infected patients, with oral regimens having > % efficacy in most patient groups. , , treatment failure currently affects approximately % of treated patients and is often associated with the selection of resistance associated substitutions (ras). we performed hcv drug resistance testing both retrospectively (following treatment failures) and prospectively (prior to treatment) in our cohort of hcv genotype (g) - -infected patients, during march -june . viral extraction, pcr and sequencing were performed at imperial college, using qiagen viral rna mini kits (qiagen pn: , qiagen ltd., manchester, uk), and inhouse pcr and sanger sequencing methods on an abi prism -avant genetic analyser (thermo fischer scientific, loughborough, uk). the prediction of hcv genotype and drug sensitivities is derived from the geno pheno algorithm [ www.geno pheno.org ]. treatment regimens used during this period complied with contemporaneous nhs rate cards: for non-cirrhotic or compensated cirrhotic patients: g -treatment-naive: omb/par/rit + das + r; g -treatment-experienced: elb/grz + /-r; g -treatmentnaive/experienced: gle/pib; g -treatment-naive/experienced: gle/ pib; g -decompensated cirrhotic patients sof/led + r; g /g decompensated cirrhotic patients: sof/vel + r. we assessed the impact of any ras across g -g on hcv rna kinetics by analysing viral load (realtime hcv viral load, abbott m , abbott molecular uk, maidenhead, england) decline rates. we applied linear mixed regression to model the viral loads and assumed a linear decline (log scale) over time, using sas statistical software (sas institute inc., nc, usa). in this cohort of patients (n: g = , g = , g = ), hcv ras were found as shown in table . hcv rna viral load decline rates were found to be similar and not statistically different ( p = . ) at: − log and − . log per month, respectively, for g and g /g ( fig. ). this suggests that these viral load decline rates were similar across g -g infections despite baseline differences in viral load, ras profile, or a history of any previous treatment (i.e. interferon-based, older ns protease inhibitor-based, or more recent daa regimens). these results demonstrate similar hcv rna clearance efficacies of the various daa treatment regimens for g -g , in this patient cohort. although other studies on hcv kinetics have been published, they do not usually compare multiple hcv genotypes. similar studies on patients infected with g - viruses, and/or undergoing other daa treatment or retreatment combinations, , will be with great interest we have read the report of zhang et al. concerning the increased susceptibility to pertussis in chinese adults at childbearing age, as determined in a comparative seroprevalence study using samples collected from to . the authors describe that about % of the individuals had pt-igg antibodies, which is indicative of a recent infection. in the adults - years of age, . % subjects had undetectable pt-igg antibodies in but . % in / . it is well known that adolescents and adults have become the reservoir of pertussis and an important source of transmission to vulnerable infants. bordetella pertussis is commonly associated with atypical pneumonia as determined in hospitalized children. several seroprevalence studies conducted in different regions of china indicate that the incidence of pertussis is most likely underestimated. , this may be due to the use of insensitive diagnostics. at present, the diagnosis of pertussis in china is mainly based on culture. however, both the cdc and the world health organization (who) use pcr as the gold standard for diagnosis, in addition to culture. oropharyngeal or nasopharyngeal swabs were obtained from , inpatients aged between days and years of age with clinical suspicion of pertussis, enrolled from march to february in shenzhen children's hospital. more than % of all patients were younger than months of age. the hospitalized patients included , males and females (sex ratio, . ). all patients recovered after the treatment. a real time pcr assay targeting ptxa-pr was used to detect b. pertussis . of the , samples, ( . %) tested positive for b. pertussis by rt-pcr. our results indicate that despite vaccination pertussis remains a major health problem in china, since the prevalence of infection by b. pertussis in hospitalized children was high. the majority of patients were admitted because of pneumonia. the detection rate in hospitalized patients was lower than the rates reported earlier in shanghai and ji'nan. , this may be due to lower number of samples collected in these studies and due to the use of serology or culture methods. the overall prevalence rates were . % and . %, respectively. however, b. pertussis infection in female patients was significantly higher than in male patients (x = . , p < . ). this has earlier been reported by the ecdc and haberling et al. and may point to a genetic association with susceptibility to b. pertussis . the detection rates were dependent on age in patients (x = . , p < . ). the prevalence decreased with age: . % newborns, . % in infants, . % in toddlers, . % in (pre-) schoolers ( fig. ) . the high vulnerability of newborns and young infants for b. pertussis infection may be related to a combination of insufficient herd immunity and suboptimal protection against b. pertussis infection in children too young to be fully vaccinated. since vaccination rates in infants are already at %, it will be difficult to improve this further. therefore, other measures must be considered, including booster vaccination at pre-school age and vaccination during pregnancy. because young infants are mainly cared for by mothers and other adults, the most important cause of infection with b. pertussis is their close contact with parents and siblings. in general, b. pertussis was detected more often during seasonal changes, especially from late summer to early autumn. in hospitalized children the number of b. pertussis infections increased in march and september as compared to other months ( fig. ) . the seasonal infection rates were . % in spring, . % in summer, . % in autumn and . % in winter, respectively. the prevalence in the winter season was lower but not statistically different than in other seasons (x = . , p = . ). in this study, we used real-time pcr, the most accurate method to detect b. pertussis . the detection rate may be significantly lower than the actual level, because oropharyngeal samples in most patients were collected instead of nasopharyngeal samples, and the pcr target gene was ptxa-pr instead of is . is is present in high-copy numbers in b. pertussis whereas ptxa-pr is a single-copy target. however, the ptxa-pr pcr is more specific and will not detect b. parapertussis , which contributes to more than % of pertussis cases. many studies have shown that adolescents and adults with b. pertussis infections, causing chronic cough, are an important reservoir for transmission, putting newborns at high risk. maternal pertussis immunization prevents infant pertussis, as recently shown by amirthalingam et al. vaccine effectiveness against infant deaths was estimated at %, and disease incidence in infants < months of age has remained low. according to our results, vaccination of pregnant women and adults, especially those in close contact with infants and young children, may help to prevent pertussis in infants and young children in china. the authors have declared that no competing interests exist. this study was supported by the sanming project of medicine in shenzhen ( szsm ) and by the shenzhen science and technology project ( jcyj ). tang and colleagues reported in this journal their experience with covid- disease , the outbreak of which began in december in wuhan, hubei province, china , with spread to additional countries - as of the st february . here we report the clinical features and outcome of the first two cases of disease caused by sars-cov- infection in the united kingdom (uk) -the first imported and the second associated with probable person-toperson transmission within the uk. public health management will be reported separately. the index case (a) entered the uk on / / from hubei province in china. initially asymptomatic, this individual, a year-old female with no past medical history and on no regular medications, developed symptoms of fever and malaise on / / , accompanied by sore throat and dry cough. she had travelled with her partner and reported no infectious contacts prior to travel. on / / , a close household contact of the index case, a resident of the uk, developed symptoms of fever ( . °c), followed the next day by diffuse myalgia and a dry cough. this patient (case b) is a previously fit and well year-old male. he had returned to the uk from hubei province on / / . case b promptly sought advice via the national health service (nhs) self-referral service nhs , and he and case a were assessed as being possibly at risk of covid- , and were admitted to the regional infectious diseases unit at castle hill hospital, hull university teaching hospitals for isolation, assessment and diagnostic sampling. they were managed in separate negative pressure cubicles with anterooms. nursing and medical staff donned personal protective equipment (ppe) as recommended by public health england (phe). the clinical observations of each of the patients, together with their initial blood tests, are shown in table . ( fig. ) . clinical examination findings were unremarkable. initial investigations revealed only mild lymphopenia and elevation of crp, with mild neutrophilia in case b. periodic fever of - . °c was observed in case b until d of admission. repeat blood tests in this individual on d demonstrated mild acute kidney injury (aki, serum creatinine μmol/l). the aki was thought most likely due to dehydration, and resolved within h with administration of intravenous infusion of crystalloid at ml/h. cxr was normal. empirical oral antibiotic therapy (co-amoxyclav / mg p.o. t.d.s.) was administered on d , to cover the possibility of secondary bacterial infection, but was subsequently discontinued. symptoms resolved in case a by d and in case b by d of admission. pcr testing of sars-cov- from nose and throat swabs taken daily was negative from d onwards in case a and from d in case b (throat swabs from this individual were negative throughout). there was no clinical indication for the use of experimental antiviral therapies. patients were deisolated according to current phe guidance, based on complete resolution of symptoms and two sequential negative respiratory pcr tests at least h apart. rooms were decontaminated with . % hypochlorite followed by uv light treatment. the contact of these individuals remained asymptomatic throughout the days incubation period but was isolated as a precaution and to be close to family these first cases of sars-cov- are informative for clinicians caring for suspected and confirmed cases in the uk and elsewhere. reassuringly, illness in both individuals was relatively mild and short-lived, with no evidence of parenchymal lung disease (reflected by normal oxygenation and the absence of radiological infiltrates) or of the late-stage deterioration that has been reported in case series , possibly due to the absence of comorbidities. experimental antiviral therapeutic options for severe disease were not considered necessary given the mild clinical nature of the illness. clinical illness correlated with the presence of viral rna in upper airway samples ( fig. ) , with no evidence of prolonged asymptomatic shedding, although discordance between nose and throat samples in case b highlights the need to sample both areas. it was reasonably assumed that the source of infection in case b was close contact with symptomatic case a, given that the time from travel to china to onset of symptoms in case b was days, although this cannot be proven. based on this assumption, the period from exposure to disease onset appeared short, at approximately h, consistent with recent reports of the incubation period of sars-cov- . co-occurrence of respiratory viral infection, as we observed in case b with rhinovirus, has been described in the context of sars-cov- ( https://www.medrxiv.org/ content/ . / . . . v ) as it has with many other respiratory viruses spread by similar routes, and may have contributed to the increased symptomatology in case b. interestingly the partner of case a, who was a close household contact, remained asymptomatic throughout and had negative tests for sars-cov- shedding. it will be of interest to investigate the serological responses in this individual to ascertain evidence of subclinical infection. isolation, minimisation of contacts and use of appropriate ppe is a cornerstone of management of high consequence respiratory viral infection. in the cases reported here, phe recommendations for ppe were followed and there were no breeches in ppe or nosocomial transmission. this should provide reassurance to healthcare workers managing patients with suspected covid- in the uk that current ppe is both feasible and effective. the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. dear editor , as reported in this journal and elsewhere, an outbreak of atypical pneumonia caused by the zoonotic novel coronavirus (sars-cov- ) is on-going in china and has spread to the world. as of feb , ( : , gmt + ), there have been , confirmed patients and more than deaths from sars-cov- infection in china, and , confirmed patients and deaths in the most affected province, hubei province. much research progress has been made in dissecting the evolution and origin of sars-cov- and characterizing its clinical features. [ ] [ ] [ ] [ ] [ ] while the outbreak is on-going, people raise grave concerns about the future trajectory of the outbreak, especially given that the working and schooling time has been already dramatically postponed after the chinese lunar new year holiday was over (scheduled on jan ). in particular, a precise estimation of the potential total number of infected cases and/or confirmed cases is highly demanding. earlier studies based on susceptible-exposed-infectious-recovered metapopulation and susceptible-infected-recovered-dead models revealed the number of potentially infected cases and the basic reproductive number of sars-cov- . , , these traditional epidemiological models apparently require much detailed data for analysis. , here we explored a simple data-driven, boltzmann functionbased approach for estimation only based on the daily cumulative number of confirmed cases of sars-cov- (note: the rational for boltzmann function-based regression analysis is presented in supporting information (si) file). we decided to collect data (initially from jan to feb , ) in several typical regions of china, including the center of the outbreak (i.e. wuhan city and hubei province), other four most affected provinces (i.e., guangdong, zhejiang, henan, hunan) and top- major cities in china (i.e., beijing, shanghai, guangzhou, shenzhen). during data analysis on feb , , the number of new confirmed cases on feb in hubei province and wuhan city suddenly increased by , and , , respectively, of which , and , are those confirmed by clinical features (note: all the number of confirmed cases released by feb were counted according to the result of viral nucleic acid detection rather than by referring to clinical features). we thus arbitrarily distributed these suddenly added cases to the reported cumulative number of confirmed cases from jan to feb for hubei province by a fixed factor (refer to table s ), assuming that they were linearly accumulative in those days. it is the same forth with the data for wuhan city. regression analyses indicate that all sets of data were well fitted with the boltzmann function (all r values being close to . ; figs. a, b, s , and table ). the potential total number of confirmed cases for mainland china, hubei province, wuhan city, and other provinces were estimated as , ± , , ± , , ± and , ± ; respectively; those for provinces guangdong, zhejiang, henan and hunan were ± , ± , ± , ± , ± and ± , respectively ( table ) ; those for beijing, shanghai, guangzhou and shenzhen were ± , ± , ± and ± , respectively. in addition, we estimated the key date, on which the number of daily new confirmed cases is lower than . % of the potential total number as defined by us subjectively (refer to table ). the above analyses were performed assuming that the released data on the confirmed cases are precise. however, there is a health commission, the state administration of traditional chinese medicine, the academy of chinese medical sciences, provinces and cities, as well as the army ( fig. ) . huoshenshan hospital is a specialized hospital established in the wuhan staff sanatorium. patients with confirmed coronavirus pneumonia have been admitted to our hospital. it has a total of beds, and includes an intensive care unit, an ordinary care unit, a laboratory, and radiology and other auxiliary departments. according to the national health commission of the people's republic of china, the related design scheme of the institute was completed on january , . construction of the hospital began on january th, and the hospital was completed and put into use on february nd. the chinese people's liberation army has transferred medical personnel to undertake the task of helping people infected with the virus. we firmly believe that chinese medical personnel and people throughout the country can work together to win this defensive battle with one heart and one mind. herpes simplex virus (hsv) pneumonia in the non-ventilated 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indebted to all colleagues who contributed to this substudy in paris and geneva. in particular, we would like to thank no public or private funds were used for the current study. eliseo albert holds a río hortega research contract from the carlos iii health institute (ref. cm / ). estela giménez holds a juan rodés research contract from the carlos iii health institute (ref. jr / ). we thank all the staff of the domestic and international organizations who fought against this outbreak, including those at the various health care facilities, lassa fever diagnostic laborato-ries, nigeria centre for disease control, world health organization, african field epidemiology network, public health england, ehealth africa, pro health international, university of maryland baltimore, us centers for disease control and prevention, alliance for international medical action, médecins sans frontières, and numerous other partners. we also express our sincerest condolences to the families and friends of those who died during the outbreak. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sector. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . this work was supported by the national natural science foundation of china ( ), and the guangdong provincial natural science foundation ( a ). we are grateful to the patients for providing their written informed consent to publish this report. our thanks go to nursing, laboratory and medical colleagues in hull university teaching hospitals nhs trust and the newcastle upon tyne hospitals nhs foundation trust who contributed directly and indirectly to patient care, and to many colleagues in public health england and across the hcid network who contributed their time and expertise to the management of these cases. cjad is supported by a clinical research career development fellowship from the wellcome trust ( /z/ /z ). we thank graduate students (boyan lv, zhongyan li, zhongyu chen, yu cheng, mengmeng bian, shuang zhang, zuqin zhang, and wei yao; all from prof. xinmiao fu's research group at fujian normal university) for data collection. this work is support by the national natural science foundation of china (no. and to xf). the reported cumulative number of confirmed cases may have uncertainty. assuming the relative uncertainty follows a single-sided normal distribution with a mean of . and a standard deviation of %, the potential total number and key dates were estimated at % ci. for detail, refer to the methods section and figs. c, d, s and s .b key date is determined when the number of daily new confirmed cases is less than . % of the potential total number. tendency to miss-report some positive cases such that the reported numbers represent a lower limit. one typical example indicating this uncertainty is the sudden increase of more than new confirmed cases in hubei province on feb after clinical features were officially accepted as a standard for infection confirmation.another uncertainty might result from insufficient kits for viral nucleic acid detection at the early stage of the outbreak. we thus examined the effects of such uncertainty using a monte carlo method (for detail, refer to the methods section in si file). for simplicity, we assumed that the relative uncertainty of the reported data follows a single-sided normal distribution with a mean of . and a standard deviation of %. under the above conditions, the potential total numbers of confirmed cases of sars-cov- for different regions were estimated ( figs. c, d, s and s ) and summarized in table , ), respectively, indicating that overall the outbreak may not be so bad as previously estimated. such uncertainty analysis also allowed us to estimate the key dates at % ci. as summarized in table , the key dates for mainland china, hubei province, wuhan city, and other provinces would fall in ( / , / ), ( / , / ), ( / , / ) and ( / , / ), respectively.finally, the ongoing sars-cov- outbreak has undoubtedly caused us the memories of the sars-cov outbreak in . we thus collected the data from the who officiate website for analysis, and found that the cumulative numbers of confirmed cases of sars-cov both in china and worldwide were fitted well with the boltzmann function, with r being . and . , respectively ( figs. e and f) .in summary, we found that all data sets, including both the on-going outbreak of sars-cov- in china and the sars-cov epidemic in china and worldwide, were well fitted to the boltzmann function ( fig. and s ). these results strongly suggest that the boltzmann function is suitable for analyzing the epidemics of coronaviruses like sars-cov and sars-cov- . one advantage of this model is that it only needs the cumulative number of confirmed cases, somehow as simple as the recently proposed model. in addition, the estimated potential total numbers of confirmed cases and key dates may provide valuable guidance for chinese central and local governments to deal with this emerging threat at current critical stage. none. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . we appreciate the work tang et al. have report emergence of a novel coronavirus in china. the -ncov broke out in wuhan, china at the end of , and has attracted worldwide attention. [ ] [ ] [ ] although the chinese government has taken active measures to control this epidemic, the virus is very infectious. according to the real-time data of the national health commission of the people's republic of china up until february , , within a short period of half a month, the number of confirmed cases and the number of deaths were , and , respectively. the epidemic is progressing rapidly. -ncov poses new public health challenges in china. in wuhan, china, the number of local medical staff is insufficient for the demand resulting from the explosive increase in the number of infected patients. therefore, many medical personnel are needed to devote themselves to the front line of combating the virus.medical personnel throughout the country are led under the unified leadership of the chinese government. although the epidemic in wuhan is serious, a large number of medical staff rushed to wuhan to supplement the shortage of manpower in wuhan hospitals. this is a battle without smoke, the heroes of which are our medical staff. according to the national health commission of the people's republic of china, as of january , , hubei province opened , isolated patient beds, and about , healthcare professionals from all kinds of medical institutions are working on the front lines and providing care for patients with fevers, and for suspected or confirmed patients. in this time of emergency, under the unified deployment of the chinese government, there are medical teams including medical personnel from the national key: cord- -kw y fpp authors: barrister, alex ruck keene title: capacity in the time of coronavirus date: - - journal: int j law psychiatry doi: . /j.ijlp. . sha: doc_id: cord_uid: kw y fpp abstract in the course of a few short weeks, many of the established legal frameworks relating to decision-making in england & wales in respect of those with impaired decision-making capacity have been ripped up, or apparently rendered all but unusable. although the mental capacity act itself was not amended, the impact of other legislation (especially the coronavirus act ) means that duties towards those with impaired decision-making capacity have been radically changed. this article reflects the experience of a practising barrister in england & wales grappling with the impact of covid- upon the mental capacity act across a range of fields in the weeks after the world appeared to change in mid-march . this paper is avowedly a report from the front line, rather than an abstract academic disquisition. it is, further, at best, a first draft of history. it reflects the experience of a practising barrister in england & wales grappling with the impact of covid- upon the mental capacity act ('mca ') across a range of fields in the weeks after the world appeared to change in mid-march . in the course of a few short weeks, many of the established legal frameworks relating to decision-making in england & wales in respect of those with impaired decision-making capacity were ripped up, or apparently rendered all but unusable. although the mca itself was not amended, the impact of other legislation (especially the coronavirus act ) meant that duties towards those with impaired decision-making capacity were radically changed. questions of isolation and social distancing raised stark questions about protectionand the ends of protectionwith particular difficulties in the context of those who could not understand what they were being asked or required to do. the intense pressure upon hospitals, and, in particular intensive care units, meant that best interests decisionmaking as the choice between available options suddenly took on a new and very stark character, and advance care planning startedin some casesto appear to be a threat rather than an opportunity. and the court of protection itself, the statutory court charged with oversight of the mca , had in a matter of weeks to transform itself into a virtual court, raising deep questions about the functions of justice and participation. this article discusses both england and wales. devolution means that there are similarities and differences between the two. the mca applies in england & wales as the framework through which decisions are made (most often informally) about capacity and best interests, on the basis of a functional model of mental capacity. the mca also provides an administrative route for deprivation of liberty for purposes of enabling care and treatment of adults in hospitals and care homes, the so-called deprivation of liberty safeguards ('dols'). outside hospitals/care homes, or in relation to those aged under , court authorisation will be required. separately, and long-predating the mca does not provide any mechanism to compel the delivery of health or social care to an individual. the court of protection has a duty to act in the best interests of the person before it, as do others (outside the court room arena) making best interests decision on their behalf. but the court of protection: […] only has power to take a decision that p himself could have taken? it has no greater power to oblige others to do what is best than p would have himself. this must mean that, just like p, the court can only choose between the 'available options.' […] . other service-providing powers and duties [outlined immediately below] also have their own principles and criteria, which do not depend upon what is best for the service user, although that will no doubt be a relevant consideration. decisions can, of course, be challenged on the usual judicial review principles. decisions on health or social care services may also engage the right to respect for private ( challenges by way of judicial review are to a different court, the administrative court, for which it is more difficult (as a generalisation) to get public funding to pay for legal assistance, and are more limited in scope, focusing on the process of decision-making much more than the outcome of the decision. the national health service act sets out the powers and duties of the national health service to provide healthcare; the care act (in england) and the social services and well-being (wales) act sets out the powers and duties of local authorities to provide social care to individuals. if an individual's needs are such as to amount to a 'continuing healthcare' need, then it is the responsibility of the nhs to meet them, and to do so for free. social care is means-tested, such that a charge can be made for the provision of such care by local authorities. in very broad terms, in relation to both healthcare (outside hospital) and social care, the relevant public body is under a duty to assess the needs of the person, determine whether they are eligible needs, and then meet them. finally, the public health (control of diseases) act contains an extensive range of powers (in part a) in relation to public health protection, including, most materially, the power to the secretary of state (in england) and the welsh ministers (in wales) to make 'health protection regulations' "for the purpose of preventing, protecting against, controlling or providing a public health response to the incidence or spread of infection or contamination in england and wales (whether from risks originating there or elsewhere)." section : health and social care outside hospital if decisions are made under the mca between the options that are actually available to the person, then changes made in relation to the powers and duties upon the state to secure the needs of individuals with impaired decision-making capacity will have a dramaticknock-oneffect upon the scope of those options. this is precisely what the coronavirus act ('ca ') has done, and i go into the changes it has introduced in some detail for two reasons: ( ) for the benefit of those within england & wales who are grappling with (for whatever reasons) the new landscape; ( ) as a case study for those concerned more broadly with the un convention on the rights of persons with disabilities ('crpd'), to make the point that examining whether persons with disabilities are able to 'enjoy legal capacity on an equal basis with others in all aspects of life' in any jurisdiction requires examination not just of the laws that on their face govern legal capacity, but also the wider framework within which those laws are placed. the ca was introduced into parliament on march , and received royal assent under a week later, on march . its long title "an act to make provision in connection with coronavirus; and for connected purposes" does not adequately convey its scope. reflecting the impact of covid- across all aspects of society, the act includes provisions ranging from emergency registration of health professionals, to the power to require information relating to food supply, to powers relating to the temporary closure of educational institutions and childcare premises, to postponement of elections to the general synod of the church of england. for present purposes, i focus upon the duties upon public bodies to assess and meet the continuing healthcare and social care needs of individuals, the latter because of their profound, indirect, impact upon decision-making in relation to those within the scope of the mca . framework for adult social care. this document, in essence, transposed principles that had been developed in relation to triage for inpatient medical treatment in the context of pandemic flu to the social care setting: recognising increasing pressures and expected demand, it might become necessary to make challenging decisions on how to redirect resources where they are most needed and to prioritise individual care needs. this framework intends to serve as a guide for these types of decisions and reinforce that consideration of any potential harm that might be suffered, and the needs of all individuals, are always central to decisionmaking. it was not just local authorities, but also the nhs, which would be stretched. i deal at section below with decision-making in hospital. here, i focus on the position outside hospital where, as noted above, the nhs (throughin england -clinical commissioning groups) has both powers and duties to meet continuing healthcare needs. the ca , with immediate effect, suspended the duty on the nhs in england to carry out assessments of whether a person is in need of continuing healthcare. crucially, such continuing healthcare needs are free to access, unlike social care provision for which charges can be made. the explanatory notes to the act rather coyly suggested this section "changes the procedure for discharge from an acute hospital setting for those with a social care need […] it allows nhs providers to delay undertaking the nhs continuing healthcare (nhs chc) assessment and pending that assessment, the patient will continue to receive nhs care." the provisions of the ca in this respect were not, in fact, so limited. although s. ca does not stop clinical commissioning groups carrying out such assessments, the (temporary) repeal of the duty mean that, overnight, individuals with profound healthcare needs lose any entitlement to assessment of those needs as a precursor to the potential for those needs to be met, for free. those of such individuals with impaired decision-making capacity therefore losein many casesthe potential for options to be made available for them in terms of their residence and care arrangements. further, given the abolition of the duty to assess, recourse to judicial review to challenge a failure to carry out an assessment becomes a nigh-on impossible task (and the court of protection can offer no assistance ) . given that there is a considerable overlap between individuals with impaired decisionmaking capacity and those with continuing healthcare needs, their options have been immediately and dramatically narrowed by this legislative change. the ca also introduced what the government (but not the act) described as 'easements' these are, respectively, ( ) the local authority is satisfied on the basis of the financial assessment it carried out that the adult's financial resources are at or below the financial limit; ( ) the local authority is satisfied on the basis of the financial assessment it carried out that the adult's financial resources are above the financial limit, but the adult nonetheless asks the authority to meet the adult's needs; and ( ) the adult lacks capacity to arrange for the provision of care and support, but there is no person authorised to do so under the mental capacity act or otherwise in a position to do so on the adult's behalf. satisfied it is not required to meet the adult's needs under section ." the statutory guidance did not explain when and how such power was to be used. section of the care act is also (when 'eased') watered down so that that the duty to meet a carer's need for support is to be tied to the necessity to avoid a breach of the carer's rights under the echr. i return to deprivation of liberty safeguards at section below. it will be clear that the watering down of duties under the care act to a 'bare bones' approach, so as to avoid a breach of the echr, means that in many cases the options available for individuals with impaired decision-making capacity are dramatically reduced. that having been said, and as a possibleand very tentativesilver lining to the cloud, the sudden and very immediate focus upon the echr may mean a renewed focus by the english courts upon the positive aspects of rights under the echr, and what those aspects mean in the context of those who cannot make their own choices. the echr has been 'domesticated' through the human rights act , such that individuals can rely upon the rights it contains before the courts, and public bodies are required to comply with it in the discharge of their functions, so, on one view, the changes introduced by the ca do nothing other than repeat a commitment which already exists. in the context of immigration control, the fiction (and it is frequently a fiction) is that the individual concerned could always return to the country from where they came from, so it is not surprising that the courts have interpreted the echr as providing a minimalist safety net designed to ensure that the uk does not breach its obligations to those individuals under the convention. no such fiction could now operate across the piece. it seems to me, therefore, that (as perhaps presciently aburas might be said to recognise ), the context is very different because, in effect, the echr is being required to do the heavy-lifting across the piece. long experience before the courts means that i do not underestimate the difficulty in persuading either a local authority orin due coursea court that it should not follow the very high bar set by the cases discussed above, which include jurisprudence up to and including the supreme court. that having been said, it seems to me that there are good arguments that courts should be more willing to place weight upon article echr alone as opposed to the general position that (absent where a family is involved ) article does not add to article echr. article is a qualified righti.e. interference with it can be justified under the circumstances provided for under article ( ) ewhc (admin), in which the situation was found to have breached article echr even though it did not breach article echr, because the entire family were in such dire straits as a result of the local authority's actions. art. ( ) applies. where the interference is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others. j o u r n a l p r e -p r o o f bodies, and in due course, the courts to proceed by reference to article echr, then there is undoubtedly an argument that it should be asked to do more work to address the middle ground where the person's circumstances are not so dire as to cross the very high threshold of article echr, but positive steps are nonetheless required so as to secure their physical health or, importantly, "psychological integrity." i would also suggest the courts should be willing to have regard to the recent jurisprudence from strasbourg relating to article whichoddlydoes not seem to have been considered domestically before the courts in england. in other contexts, the courts have been willing to accept that the crpd can be of assistance in interpreting the application of the echr. if the statute itself now directs the courts to consider the provisions of the echr (and, by extension, the crpd), then the approach in davey may no longer seem quite so tenable. put another way, if the statute itself asks the echr to do more work as the safety net for those with disabilities, it is legitimate to ask those applying the statute to look to the crpd to assist in ensuring that safety net has as few holes in as possible. whether advocates andin due coursethe courts will be willing to run with arguments such as those set out above is, at the time of writing, an open question. but if they do, they may, ironically, have further blurred the distinction between the civil and political rights traditionally seen as the core of the echr and socio-economic rights (i.e. rights which actually require states to spend money). j o u r n a l p r e -p r o o f individual level, the rights to independent living and to health enshrined in the crpd. such would be of inestimable benefit to those with impaired decision-making capacity. the lives of those with impaired decision-making capacity have also directly, and, as will be seen, disproportionately, been affected by the public health measures taken to respond to the covid- crisis. in the same week as the ca came into force, regulations made under the public health (control of disease) act radically changed the legal landscape in england & wales, effectively placing the population under severe restrictions (which the daily mail might even characterise as house arrest) for their good, and the good of society. the health protection (coronavirus, restrictions) (england) regulations are set to expire in months' from the date of their coming into force on march , although with reviews by the secretary of state every days. whilst the regulations are in force however, there are statutory restrictions on every person in england from leaving the place where they are living "without reasonable excuse." the regulations provided for statutory steps which could be taken to enforce this, including the power for a relevant person to direct the person to return the place to where they were living or remove them to the place where they are living (including by the use of reasonable force). the person would also be also committing a criminal offence (which can be discharged by way of the issue of a fixed penalty notice). what constituted a "reasonable excuse" for these purposes is set out in regulation ( ). this included taking exercise, as well as 'to avoid illness or injury or to escape a risk of harm.' there are some very interesting questions that arose as to whether the regulations were ultra vires the act under which they were made (the public health (control of disease) act ). i do not address them here, but david anderson qc wrote a stimulating blogpost on the question. interesting questions also arise as to whether they gave rise to the deprivation of liberty of the entire population of england & wales for purposes of article ( ) echr (and, if so, whether it is justified under article ( )(e) for purposes of the "prevention of the spreading of infectious diseases"). these are both interesting questions, my tentative thoughts being, respectively ( ) probably not; but ( ) for present purposes, i focus on the fact the regulations did not make any provision in relation to those with impaired decision-making capacity. the question arises, therefore, as to how they should be applied to someone who lacks the capacity (applying the mca , or any common law test that might be said to apply) to understand: ( ) that they are required not to leave the place where they are living without a (statutory) reasonable excuse); or ( ) the consequences of so doing without such a reasonable excuse? and should they be subject to criminal sanction if they do so? one would like to think that it would be very unlikely that any prosecution would be brought against a person who did notbecause they could notunderstand what it is that they should or should not have been doing. the guidance issued by the crown prosecution service in relation to prosecution of offences under the regulations provided that: the guidance made no reference to the presence of impaired decision-making capacity as a factor. it is also, equally, troubling that it would even be possible for a criminal prosecution to be in contemplation in such circumstances. it may, perhaps, be that the answer is to be found in the wording of regulation ( ), which is not exclusive in terms of reasonable excuses. rather, it provides that "a reasonable excuse includes." that a person lacks the capacity to understand what it is that the new regime requires would appear, on its face, to be a reasonable excuse. whether any of the near constant stream of guidance coming out (but not, so far, relating to the mca specifically) will address this issue is not known, but i would hope it would. i should note that, under regulation ( ), it would undoubtedly be possible for a person to be returned to the place where they are living by the use of reasonable force whether or not they had the capacity to agree to the steps being taken. interestingly, and undoubtedly by a side-wind, this suddenly given a previously missing power to police offices, and other authorised people to return individuals subject to dols authorisations in care homes where they have 'wandered' (a term i put in parenthesis because in many cases, it is very far from purposeless wandering on the part of a person with j o u r n a l p r e -p r o o f dementia). but this was undoubtedly not the purpose for which regulation ( ) was enacted. it would also leave anyone who does take steps to return an individual to somewhere other than a care home in a difficult position. the regulations did not provide the power for the person returning the person to where they live to prevent them from leaving their home; any such power would have to (legally) be found in another source, and (practically) be exercised by someone. and what if the person lived in their own home, and did not appear to have anyone there to 'receive' them? finally, i note that those caring (formally or informally) for those with impaired decision-making capacity are left in a very invidious position. should they be seeking to prevent the individual from leaving home so as not to breach the regulations, or should they let them do so in the hopes that the individual does not then encounter an unsympathetic relevant individual. it is very likely that many carers will feel (rightly or wrongly) that they have to take steps to stop the person leaving. in many cases, this is likely then to mean that the individual then meets the 'acid test' of not being free to leave the place they live and also being subject to continuous supervision and control. if they cannot consent to that confinement, then it is very likely that they are then to be seen as deprived of their liberty for purposes of article echr. i return to this issue below having looked at the further powers that the ca introduced in the public health sphere. section and schedule ca contain powers relating to potentially infectious persons. part relates to england; part to scotland and part to wales. they are materially identical, and for present purposes i will only give references to the paragraph numbers in part (for england). schedule provides public health officers, constables and (in some circumstances) immigration officers with the means to enforce public health restrictions, including returning people to places that they have been required to stay. where necessary and proportionate, constables and immigration officers are able to direct individuals to attend, remove them to, or keep them at suitable locations for screening and assessment. where a person has been screened and assessed and either tested positive, or the screening is inconclusive, paragraph of schedule enables a public health officer to impose requirements including to remain at a specified place (which may be a place suitable for screening and assessment) for a specified period; and/or to remain at a specified place in isolation from others for a specified period. ('a requirement to remain'). the public health officer has when imposing a requirement or restriction to inform the person of the reason for doing so, and that it was an offence to fail to comply with the requirement or restriction. a person can only be required to remain at a place for a maximum of days, , although can be required to remain in isolation indefinitely (although with a review every hours after days). a failure to comply with the requirement to remain at a place or in isolation is a criminal offence. j o u r n a l p r e -p r o o f removing someone to or keeping the person at a place under the powers identified here; failure to comply with a reasonable instruction is a criminal offence. a constable or immigration officer (but not a public health officer) can use reasonable force, if necessary, in the exercise of the powers outlined here. the recourse against the exercise of the draconian (if justified) imposition of a requirement to remain is by way of appeal to the magistrates' court. none of the provisions outlined above make any reference to the position of persons with impaired decision-making capacity. the closest that they come are in paragraph , where a public health officer is required in deciding whether to impose a requirement to remain "must have regard to a person's wellbeing and personal circumstances." "personal circumstances" here couldand arguably shouldinclude whether they have capacity to understand what it is that they are being required to do, and the consequences if they do not. in the event that a requirement to remain was imposed, it was not obvious from the face of the ca how it is that a person with impaired decision-making capacity is to make any appeal to the magistrates' court. so as to comply with the provisions of articles and echr (read alone or in conjunction with article echr), it is clear that the appeal provisions in paragraph will have to be interpreted ( ) as placing the threshold for bringing an application extremely low (as per the approach before the mental health tribunal or the court of protection ); and ( ) where the person does not meet that threshold, enabling another person to act on their behalf to bring the application. it was entirely possible that there are those who do have impaired decision-making capacity and pose a public health risk because they are either potentially or actually infectious with covid- . precisely what legal powers could be exercised to require them to remain either in a place or (within that place, within isolation) is a question that has exercised many commentators. four key issues are: significant doubts remain as to the thickness of legal ice upon which professionals are standing. had the mental capacity (amendment) act been in force, professionals would have had the ability to rely upon a revised version of s. b mca making clear the basis upon which they were able to deprive an individual in need of care and treatment in an emergency, and then pending completion of the relevant statutory processes. however, the likelihood of implementation of that act, requiring a substantial amount of work on the part of local authorities and nhs bodies, which was already looking unlikely for october , receded rapidly into the distance. very shortly after 'lockdown' started, the court of protection had cause to consider how dols was working in the context of a care home whichas with many othershad barred visitors. it is also striking (but perhaps reflective of the haste with which the application was brought on and considered) that hayden j did not address the fact that the dols regime does not, itself, provide authority to restrict contact, so it is not immediately obvious upon what legal basis contact could be restricted except by going to court. finally, it is also, perhaps, striking that no arguments were addressed to hayden j (or raised by hayden j of his own motion) as to the risk posed to individuals within the care home by covid- . on one view it could have been argued (see further section ) above that bp's article rights in fact pointed not to the cessation of contact between him and his family, but for his rapid move to his daughter's house, and the provision of such support to her there as required to ensure he could be kept safe there. not only would the court of protection have to find ways in which to ensure that family members and/or informal carers did not feel excluded by the arrangements, the court would have to find ways in which to ensure that sometimes painful progress towards the greater participation of the subject of proceedings -'p'was not lost. the guidance noted above from hayden j actively solicited "[i]maginative ideas […] to ensure that p participates in their proceedings where they are able to so do safely and proportionately." but given that "[w]here judicial meetings with p are necessary for a determination of the issues then remote conferencing technology to facilitate that meeting is the only likely mechanism," immediate hurdles towards an important way in which such participation could take place were clear. the energy and commitment of those concerned with the court to ensure that it could continue both to offer a service, and to serve p was clear, but the task at the time of writing appeared formidable. space precludes a detailed consideration of the issues that arise in the context of the effect of covid- upon the scarce critical care resource within england & wales, and also the scarce resource of ventilation. however, they do need to be touched on briefly as radically changing the framework for medical decision-making. in a series of cases starting in , the court of protection had developed an increasingly sophisticated notion of best interests in this context in which even interventions with a very small chance of success could be said to be in the best interests of the patient if it was clear that this is what they wanted. this did notquitecross the line into holding that approaching matters through the prism of best interests could require that clinicians provide treatment that they did not consider clinically appropriate, but on occasion came very close. the impact of covid- , however, means that it appears clear that decision-making in the case of those with impaired decision-making (and whether or not they have covid- ) might have to be undertaken on the basis not of what was in their best interests, but on a utilitarian basis in order to save the maximum number of lives. what had been a perennial question for ethicists and the subject of planning that had never had to be moved into anything close to an operational phrase has become an ever more pressing issue. however, national bodies (in particular national nhs bodies) have been notably slow to produce guidance addressing the issues, perhaps because of political (including health service political) concerns as to the public reactions that would be engendered by the recognition of the reality of the position. they are also perhaps aware of how guidance produced under speed in countries that had been affected ahead of england (most notably that produced by in the italian context by siaarti, which suggested that there might need to be a simple age cut-off for admission to icu ) would look if transposed directly into the english context. further, an earlyand very high-level -attempt to provide guidance (the nice 'rapid response' guideline ng ) was the subject of threatened judicial review proceeding within hours because of the perception that its reliance upon a tool known as the critical frailty score would discriminate against individuals with learning disability or other 'stable' cognitive impairments. it was perhaps not a coincidence that it took another days before any other body (this time the british medical association) put its head above the parapet, that time to press coverage including the headline "virus patients more likely to die may have ventilators taken away"). guidance from the chief medical officers (who appeared frequently in the : press conferences that became such a feature of the crisis) was still not forthcoming at the time of writing. whilst there was limited 'off-the-shelf' material that could be drawn upon, much of that material did not, in fact, provide the sort of detailed operational detail as to either procedures or criteria that was really required. this meant, therefore, that clinicians have bene left at a vital period in the run up to the peak essentially trying to make it up as they went along, frequently seeking to do so whilst juggling heavy, and increasing, clinical loads at the same time. they have also been left unclearand in many cases in real moral distress in consequenceas to the point at which they were supposed to stop applying ordinary principles of medical decision-making and instead to start operating in a world governed by some form of utilitarianism. a further consequence of the slowness of national bodies to give direction was that nhs trusts have not been not given either the 'push' or the tools to start creating the governance structures which would be crucial to ensure that triage decisions take place within structures that could provide both oversight of the process and support to clinicians operating within it. this has had one particularly pernicious consequence in the case of those with disabilities, including those with impaired decision-making capacity. whether out of a misplaced excess of zeal in attempting to undertake advance care planning, a misunderstanding of the law, or otherwise, it appeared that significant numbers of individuals were having decisions made as to resuscitation without any form of consultation; in other cases, it appeared that individuals were being pressured into signing their own dnacpr notices. many such individuals were elderly, but did not have specific disabilities. in other cases, it appeared that judgments were being made that (e.g) cpr should not be attempted because they had, for instance, a learning disability. this prompted an urgent letter from the national director for mental health, nhs england and nhs improvement, the national clinical director -learning disability and autism nhs england and nhs improvement and the medical director for primary care, nhs england and nhs improvement to remind trusts and gps that: the health of some people who have a learning disability and / or a diagnosis of autism may be at risk from the presence of co-existing physical conditions and also from inequities in access to and delivery of appropriate and timely assessment and treatment for physical health conditions. end of the pandemic makes a more or less cheering read than it does at present will depend, in very significant part, upon the actions taken by those who care about capacity law over the coming months, when it will be tested as never before. by the committee on ethical aspects of pandemic influenza in : see department of health 'responding to pandemic influenza-the ethical framework for policy and planning (london: department of health under, in particular, the national health service act coronavirus act explanatory notes department of health and social care 'care act easements: guidance for local authorities department of health and social care 'care act easements: guidance for local authorities a guide to the implementation of the european convention on human rights whether a person already subject to a dols authorisation at a particular care home or hospital (or, indeed, a patient detained in hospital under the mha ) was then subject to sufficient additional restrictions in consequence of being kept in isolation within that facility so as to give rise to an additional deprivation of their liberty whether it was legitimate to use dols to authorise deprivation of liberty for purposes of preventing the spread of infection from the person given the statutory requirement that a dols ca ca sch and it was anticipated at the time of writing that statutory guidance would confirm this position ors (duties and powers of relevant person's representatives and section d imcas where baker j held that the capacity to ask to issue proceedings "simply requires p to understand that the court has the power to decide that he/she should not be subject to his/her current care arrangements. it is a lower threshold than the capacity to conduct proceedings a clinical commissioning group v af & ors note, as the blog itself makes clear, it was revised subsequently to reflect the views of the man's daughter. as to the judge's perspective, see catherine baksi remote justice: a family perspective for an overview of how the court had been seeking to improve participation, see mr justice charles a clinical commissioning group v af & ors a clinical commissioning group v af & ors for a discussion of the issues more widely as they stood at the start of april , see dominic wilkinson, 'icu triage in an impending crisis: uncertainty, pre-emption and preparation which aintree reinforced could not happen: see paragraph ewcop , i which keehan j, considering the submission that cpr would not be in the best interests of the person, noted that "key to the decision must be the wishes and feelings of hb and it is plain that administering cpr in the event of a further collapse and giving her, albeit a very, very small chance of life, is what she would wish for an overview of the legal and ethical issues that arose in that context (together with the framework within planning had started), see alex ruck keene resuscitation and intensive care): clinical ethics recommendations for the allocation of intensive care treatments in exceptional, resource-limited circumstances -version n covid- rapid guideline: critical care in adults nice guideline virus patients more likely to die may have ventilators taken away the author thanks mary donnelly for her very rapid assistance with editing, and the two reviewers for their incisive, constructive, and exceptionally speedy responses. any errors remaining are the responsibility of the author. at the time of writing, it remained unclear whether this letter would produce a material effect. the focus of this article has been upon mental capacity, rather than mental health law. however, for completeness, and because of the overlap between individuals with impaired decision-making capacity and those falling within the scope of the mha , it is important to note that here, too, the landscape has been changed. this is not just because of the complexities of addressing public health concerns within psychiatric hospitals, which bring with them similar issues to those discussed above in relation to dols, but also because of changes to primary legislation.the ca includes (in s. and schedule ) the power to make temporary changes to mental health and mental capacity legislation across the united kingdom. those powers include the ability drastically to strip back the procedural safeguards around admission and treatment under the mental health act ; it is perhaps odd, given how much more relevant the mca is to the response to the pandemic, that the ca only addressed the mha in primary legislation. at the time of time of writing, those powers have not been brought into force. however, the power under the act to enable changes to the composition of the mental health review tribunal for wales was brought into force on enactment, mirrored by a pilot practice direction in england. at a stroke, tribunals were reduced to single judges (as opposed to a judge sitting with a medical member and a specialist lay member) sitting remotely, with hearings taking place largely by telephone. i do not dwell further upon these changes, except to say that the reader can easily imagine the practical impact upon all concerned, above all the patients. as noted at the outset, this tour d'horizon of the state of mental capacity law in england & wales only a short time into the covid- pandemic presents a challenging picture. across the board, options are being removed, and constraints necessary for utilitarian goals being imposed with inadvertent, and often disproportionate consequences. but there are glimmers of hopefor instance in the potential for the echr to be a very much more powerful tool than it has been to date in terms of securing service provision. and in a world where nothing appears certain, and everyone, irrespective of disability, is seeking answers, it is arguably easier than it was ever before for supported decision-making to appear something of universal relevance. whether and how the second draft of history to be written after the for an overview, see the essex chambers rapid response guidance note: covid- and the mental health act , available at https://www. essex.com/tag/mental-capacity-guidance-notes/ (accessed april ). it is quite possible that this was down to the fact that changes had had to be contemplated in relation to the mha in in the context of swine flu, so, to some extent, there were legislative amendments which could be taken off the shelf. section of and part of and paragraphs , and of schedule , by virtue of the coronavirus act (commencement no. ) (wales) regulations (si no. (w. )) pilot practice direction: health, education and social care chamber of the first-tier tribunal (mental health), march . linked also to this were the very substantial difficulties caused by the practicalities of complying with a legal aid system dependent upon a set of procedures that were not easily adaptable for remote working. there of course, a considerable irony to this given that the conservative government has repeatedly expressed hostility to the echr, and a desire to revisit how human rights are protected in the united kingdom, including through a british bill of rights.j o u r n a l p r e -p r o o f key: cord- -oio zsb authors: marko, curkovic; andro, kosec; petrana, brecic title: stay home while going out – possible impacts of earthquake co-occurring with covid- pandemic on mental health and vice versa date: - - journal: brain behav immun doi: . /j.bbi. . . sha: doc_id: cord_uid: oio zsb nan in an ongoing covid- pandemic setting, there is an interplay between two disastrous events -one related to the infectious agent and other related to previously unprecedented response strategies. their ability to reinforce one another is unknown, as well are the relative shares in long-term effects. mental health here seems of crucial importance, as the current sars-cov- pandemic is characterized by psychological reactions arising from feelings of uncertainty alongside limited availability and possibility for "healthy" coping. restrictive public health measures have severe unintended psychological and social consequences, characterized by deprivation of fundamental right and freedoms and restrictions on work, mobility and social support (brooks et al., ; galea, et al., ) . it has been widely reported that such a setting has deleterious effects on mental health in persons (in)directly in contact with the infectious agent; persons that are vulnerable to biological and psychological stressors; frontline professionals and members of general public (brooks et al., ; fiorillo and gorwood, ; li et al., ; montemurro, ; . the pandemic may exacerbate existing mental health disorders (that are highly prevalent) and contribute to "new" stress-related mental health disruptions and disorders even in previously unaffected ("healthy") populations. this is followed by limited availability and access to mental health services creating a significant gap between needs and possibilities (galea, et al., ; pfefferbaum and north, ) . the evolving pandemic is followed by a widespread feeling of uncertainty concerning infectious agents' origins, nature and course of the disease it causes. even though most of the population is not directly affected, possibility of infection and unprecedented levels of media coverage and exposure amplify the effects on mental health, further deepening the feelings of uncertainty and the state of overwhelming stress (galea, et al., ; usher et al., ) . it is extremely difficult to disentangle the true source and relative impact of distinctive, but interrelated "stressors", as those related to threatening agent, inadequately prepared health care systems, and those related to response procedures and strategies (usher et al., ) . social/physical distancing and isolation is severely undermining most fundamental intrinsic coping and adaptive strategies. the city of zagreb, capital of the republic of croatia, was afflicted by another, traditional disaster while being in the middle of pandemic with restrictive public health measures, such as restriction on transport and travel, working and educational activities, alongside recommended measures of physical distancing and (self)isolation. devastating earthquakes, . and . on richter scale hit the capital, the pandemic "hotspot", in early morning hours ( : and : am) on march nd, . so, a relatively "new" form of mass traumatic event was accompanied by relatively "traditional" one, urging a need to consider its cumulative effects especially on mental health. the pandemic narrative was interrupted by earthquake, a visible and imminent threat, especially as this was, for most citizens, the first such experience in their lives. most natural and protective responses to such a disaster, such as seeking comfort from the closest ones and/or escape to available "safe spots", were forestalled as they could potentiate infectious disease transmission. this conversion of adaptive strategies to maladaptive ones was even more pronounced as the agent causing pandemic is invisible, and in croatia till that time had not produced significant consequences. so, alongside a deep feeling of uncertainty came a similarly distressful and deep feeling of insecurity. on the other hand, one could hypothesize that such additional, "traditional" disasters may have had positive psychological and social effects on "unconventional" ones -the pandemic. for example, certain materialization and shared experience of threat in the form of earthquakes made citizens more aware of invisible one and allowed more constructive meaning making processes (brooks et al., ; fiorillo and gorwood, ) . additionally, materialization of threat may have provoked the feeling of shared identity allowing shared beliefs and purpose to emerge. during pandemics, the number of people whose mental health is affected tends to be greater than the number of people affected by the infection. this is certainly going to be more pronounced in a context were peritraumatic phase of the covid- was reinforced by another deeply traumatic experience. even if most people prove to be resilient in the long-term, and a significant minority expresses mental health disruptions, this could mean an enormous mental health burden, further impeding recovery process. disastrous events have various effects on individuals, as some may be more susceptible to its adverse effects, while others may be more resistant or resilient. these effects are not only driven by different states and/or traits of individuals, but also by their pre-disaster as well as post-disaster context (druss, ; duan and zhu, ; pfefferbaum and north, ) . hopefully, widespread activation and digital transformation of mental health resources and systems will be able to provide much needed care (druss, ; duan and zhu, ; fiorillo and gorwood, ) . no funding was received for the preparation of this manuscript. mc provided initial idea and drafted initial version of the manuscript. mc, ak and pb edited, reviewed, and prepared the manuscript for submission. all the authors contributed to and approved final version of the manuscript. the psychological impact of quarantine and how to reduce it: rapid review of the evidence addressing the covid- pandemic in populations with serious mental illness psychological interventions for people affected by the covid- epidemic the consequences of the covid- pandemic on mental health and implications for clinical practice the mental health consequences of covid- and physical distancing: the need for prevention and early intervention vicarious traumatization in the general public, members, and non-members of medical teams aiding in covid- control the emotional impact of covid- : from medical staff to common people mental health and the covid- pandemic life in the pandemic: social isolation and mental health a longitudinal study on the mental health of general population during the covid- epidemic in china mc and pb have received lecture honoraria from lundbeck, sandoz, janssen, pliva (teva) andalkaloid. ak have no conflicts of interest to declare key: cord- -w sk m authors: caduff, carlo title: what went wrong: corona and the world after the full stop date: - - journal: med anthropol q doi: . /maq. sha: doc_id: cord_uid: w sk m this article examines the global response to the covid‐ pandemic. it argues that we urgently need to look beyond the virus if we want to understand the real seriousness of what is happening today. how did we end up in a space of thinking, acting, and feeling that has normalized extremes and is based on the assumption that biological life is an absolute value separate from politics? the author suggests that today's fear is fueled by mathematical disease modeling, neoliberal health policies, nervous media reporting, and authoritarian longings. it is as though mankind had divided itself between those who believe in human omnipotence (who think that everything is possible if one knows how to organize masses for it) and those for whom powerlessness has become the major experience of their lives. ---hannah arendt the measures that governments across the world have taken to contain the spread of coronavirus disease are massive and unprecedented. as a result of these measures, life has come to an almost complete standstill, with many countries under lockdown. never in the history of humanity have such drastic interventions into the lives of populations occurred in the name of health on such a scale and in such a short period of time. as a result of the world's largest and perhaps most stringent lockdown, millions of daily wage laborers have lost their source of income in india. health care workers have been attacked and evicted from their homes because they are seen as potential spreaders of contagious disease (kalra and ghoshal ) . neighborhoods have been scared into panic when an ambulance appears on the street. due to the sudden ban on any form of transportation, migrant workers have been stranded between the cities where they used to work and the villages where their families are living (daniyal et al. ) . cancer patients have been unable to receive essential medical care because they cannot reach the hospital. it is the poor, the marginalized, and the vulnerable who are most affected by drastic measures, exacerbating already existing inequalities. in kenya, the police enforced a coronavirus curfew using teargas and excessive force against presumable violators of lockdown law (namwaya ) . in bangladesh, the government created a special unit to monitor social media and arrest people for spreading "misinformation" about the virus (hrw ). in hungary, parliament passed a law allowing prime minister orbán to limit freedom of speech, defer elections, and suspend rules and regulations by decree (gebrekidan ) . in india, state governments released companies from the purview of labor laws, including occupational health laws, to stimulate the economy (sharma ) . in lebanon, the currency collapsed, leaving % of the population in need of food aid (chulov ) . in the united states, over million people have filed for unemployment benefits (rushe and aratani ) . unfortunately, as of the writing of this article, many things remain completely unknown in this pandemic despite intensive investigation. for example, we don't know what helped contain the outbreak in china, and particularly whether government interventions reduced the spread of the virus or if the virus burned out there before moving on to other susceptible populations. the fact is: we simply don't know. nevertheless, many actors and institutions have proceeded as if they did know, imposing extreme measures that have affected billions of people and that have pushed societies to the edge of collapse by creating poverty, hunger, misery, debt, and unemployment. today, many wonder how we ended up where we are. how was it possible for a virus to trigger such a massive response that continues to threaten society and the economy, with so little discussion about the costs and consequences of extreme measures? why is there widespread agreement that aggressive interventions to "flatten the curve" were necessary and justified? it seems that this unprecedented public health experiment occurred without sufficient consideration of the social, political, and economic consequences. the failure to consider the impact of extreme measures that have become the norm in many places in the covid- pandemic has been stunning. the destruction of lives and livelihoods in the name of survival will haunt us for decades. the coronavirus disease outbreak seems to have started in the chinese city of wuhan in december . in january, the chinese government put wuhan and other major cities in the province under lockdown. a lockdown of million people "is unprecedented in public health history, so it is certainly not a recommendation the who has made," dr. gauden galea, the world health organization's (who) representative in beijing, emphasized at the time (reuters ). in other provinces, the chinese government implemented tailored measures, including factory shutdowns and school closures, but not a lockdown or restriction of movement to limit the spread of disease. major media outlets in the united states called china's locked-city strategy deployed in and around wuhan "harsh," "extreme," "severe," and "controversial," emphasizing that it offered "no guarantee of success" (qin et al. ) . a new york times article noted that "china is trying to halt a coronavirus outbreak using a tactic … with a long and complicated history fraught with social, political and ethical concerns" (levenson ) . experts quoted in the article called the lockdown of cities "an unbelievable undertaking" that would be "patently unconstitutional in the united states." "that type of thing," said james hodge, a professor of law, "is obviously an excessive response." another expert cited in the article, historian howard markel, pointed to the "darker side of quarantine-its use as a social tool rather than its scientific use as a medical tool." in the united kingdom, newspaper articles suggested that the chinese government would not be able to keep the city of wuhan "closed for business indefinitely" (graham-harrison ). in february, the virus continued to circulate and soon appeared in other countries. in march, the who declared the covid- outbreak a global pandemic. despite the criticism of china's approach, a crude and extreme version of lockdown became the international norm promoted by experts, officials, and the media across the world. concerns with the dark side of quarantine faded rapidly. a few countries like south korea veered from this norm and chose instead a classic infectious disease intervention: test-trace-isolate, with a highly centralized approach to public health intelligence gathering. emphasizing mass testing and meticulous contact tracing to interrupt the chain of transmission, south korean health officials closed schools and managed the crisis successfully without any lockdowns or roadblocks, and few restrictions of movement. significantly, south korea learned from earlier outbreaks of infectious disease (sars in particular), and imposed central control, used digital technologies, and enforced quarantines, and it witnessed one of the lowest covid- mortality rates. by the end of april , around , cases of infection had been detected there, but only people had died. germany developed its own testing protocol, which was published on january by the who (beaumont ) . when the first case was detected on january , germany launched mass testing, systematic contact tracing, and early hospitalization, keeping the mortality rate low and hospitals functional even when cases of infection increased (mohr and datan-grajewski ) . health officials relied on an extensive network of laboratories and were able to conduct over , sars-cov- (covid- ) tests per week (buck ) . along with south korea, germany put testing and contact tracing at the heart of the response. despite the who's emphasis on testing and south korea's and germany's early success in reducing the spread of the virus, most countries considered testing at scale as a low priority and relied on an extreme version of the chinese approach of lockdown. however, in china, the approach was tailored and regionalized; as a who report noted, "specific containment measures were adjusted to the provincial, county and even community context, the capacity of the setting and the nature of novel coronavirus transmission there" (who ). the lockdown focused on the major cities in the most affected province, constraining the life of million people in a country of . billion. in other words, it was a limited lockdown affecting % of china's total population. in contrast to the tailored and regionally differentiated intervention that sought to minimize the socio-economic impact of the response, many other governments across the world imposed nationwide lockdowns that went far beyond china's locked-city approach. in practice, these lockdowns amounted to curfews (often legalized after the fact by emergency laws). italy was the world's first country with a nationwide lockdown/curfew. many countries followed suit, partly motivated by shocking images of overwhelmed hospitals in italy's north and partly driven by a disease model report released in the united kingdom a few days after italy's surprising national lockdown announcement . this moment of shock and surprise triggered a chain reaction in the pandemic response. the horizon shifted, the inconceivable became possible, and life suddenly felt surreal. the u.k.'s disease model garnered a lot of attention, creating a sense of urgency that amplified the political pressure because the numbers were alarming . published by a group of experts without peer review on an institutional website, the report compared covid- with the great pandemic of , which killed over million people worldwide and suggested, without any evidence, that sars-cov- was "a virus with comparable lethality to h n influenza in ." most frightening in all this was not so much the lethality of the sars-cov- virus but the license to rush forward with predictions, abandon basic standards of science, and make dramatic claims to scare people. for covid- , the report predicted , deaths in the united kingdom and . million deaths in the united states. it presented possible strategies to reduce the impact of the pandemic, but the focus was exclusively on "non-pharmaceutical interventions." there was no discussion of testing and contact tracing. a proven public health strategy known to be effective was systematically sidelined in one of the most influential reports to emerge in the covid- pandemic. significantly, the report claimed to focus on "feasibility" of measures and promoted the idea that systematic suppression of transmission would work best-in other words, lockdowns. however, it excluded from any consideration the social, political, and economic implications of lockdowns, noting that "no public health intervention with such disruptive effects on society has been previously attempted for such a long duration of time." in addition to ignoring testing and contact tracing as a possible strategy, disregarding the social, political, and economic implications of lockdowns, and conceding that there is no "easy policy decision to be made," the authors of the report felt confident enough to claim that "suppression" was the "preferred policy option" and the "only viable strategy" that countries across the world needed to implement "imminently." the lockdowns that were required for suppression would need to be maintained "until a vaccine becomes available" (which they predicted to be "potentially months or more"). a crude, extreme, and ultimately unsustainable version of the chinese approach became the international norm. shutting down society and the economy until a preventive medical treatment becomes available was advanced as an appropriate response and the only possible way of dealing with the crisis, despite the costs and consequences. italy figured as an important but fundamentally ambivalent model, shifting the locked-city into a locked-country approach. the italian scenario was sobering and frightening but also inspiring and motivating. to avoid italy's disaster, governments appropriated the italian approach of mass confinement and rigid restriction of movement as a one-size-fits-all intervention. in many places throughout the world, including italy and france, the locked-country approach took a militarized form with massive deployment of the police to enforce lockdown restrictions. the locked-country approach seemed to obviate the necessity of justifying a differentiated strategy that might have looked unequal and unfair and that might have intensified social and political conflicts along multiple internal fractures and fault lines. to avoid the political fallout of a differentiated strategy, which would have required systematic testing, government officials in europe and elsewhere invoked the politically expedient image of a total threat and suggested that "we are all in the same boat" and that "we are all in this together." the idea that regional lockdowns would not be possible and that it was best to treat the virus as a global threat that would uniformly impact all people involved conjuring an image of a united nation confronting a total threat that required everyone's sacrifice. this image relied on a false assumption of equality. solidarity came to mean not mutual support in a situation of uneven risk, but rather generalization of a sense of danger across a national population perceived as a homogeneous body under attack. the ideology of national pandemic solidarity-putting everybody under confinement and treating everyone the same-obscured the reality that lockdowns mean different things to different people, and that not everyone is equally exposed or equally vulnerable. both the virus and the lockdown disproportionately affected those who were already vulnerable along lines of age, class, and race. dramatic references to the magnitude of the threat served as justification for nationwide lockdown policies. this extreme and unprecedented blanket approach systematically imposed on entire populations was driven by a number of factors that variously prevailed in different countries across the world: a growing sense of panic, constant media sensationalism, deep authoritarian longings, increasing political pressure to contain the spread of the virus, disturbing accounts of overwhelmed hospitals unable to cope with the surge of patients, misleading mortality calculations, and, most importantly, a trust in the power of mathematical disease modeling. throughout the covid- pandemic, there has been an abiding assumption among observers and the public that it is clear what is happening; that everyone knows what is going on because everyone can see it on television. however, what an endless stream of media reports from around the world have continued to obscure is the fact that it is impossible to know what is happening in a population when there is no systematic testing. the lack of testing created a void that was filled by the flexible evidence of disease modeling. in the absence of robust data, disease modeling emerged as the presumably best and only available science to inform policy. media hyperbole focused on absolute numbers independent of context and made covid- deaths politically visible. flexible disease modeling (often based on data derived from viruses such as influenza) took the place of accurate epidemiological surveillance. scientific papers published online without peer review made scary projections and painted a grim picture. widely reported simulation models created shock effects that shaped government policies. a narrow focus on numbers played an important role in understandings of the magnitude of the threat, fueling fear and panic in the absence of actual evidence. a distinct imaginary took hold, "the imaginary of an unprecedented event," which seemed to require an unprecedented response (kelly ). there was a widespread sense, among experts and the media, that the sars-cov- virus was much more lethal than influenza. that this pandemic was different from influenza and thus necessitated a different approach was typically claimed on the basis of the case-fatality rate, the number of deaths as a subset of those infected with sars-cov- . the casefatality rate played a crucial role in the justification of the public health experiment now unfolding before our eyes. estimates of the case-fatality rate initially varied hugely from . % to %. in an article published in the lancet, scientists claimed the case-fatality rate could even be as high as % (baud et al. ). in early march , the who directorgeneral stated that the case-fatality rate for sars-cov- was . %. he added: "by comparison, seasonal flu generally kills far fewer than % among those infected." whatever the estimates, the fact remains that it is impossible to calculate the case-fatality rate in the absence of systematic testing. given the lack of evidence, the only scientifically valid statement at the time would have been to say that we simply don't know how lethal the virus is. early on in this pandemic, it became clear that over % of infected people were experiencing no symptoms at all at the time of testing (gudbjartsson et al. ) . this means that a surveillance regime where only people with symptoms were tested will automatically exclude a large number of infections. additionally, patients with symptoms are much more likely to die than asymptomatic people. the result is an exaggerated case-fatality rate. testing strategies differed across countries and changed within countries over time. for example, on february , , the italian ministry of health published a revised policy for testing, prioritizing patients with severe clinical symptoms (and thus higher chances of dying). this change in policy resulted in an apparent increase in the case-fatality rate of . % on february to . % on march (onder et al. ) . suddenly, the virus seemed to have become much more deadly. however, this increase was a numerical illusion-a statistical artifact. there was no change in the lethality of the virus. changes in testing policy occurred in many countries and even across regions where different tactics for counting deaths were used. in china, test-positive asymptomatic patients were excluded from being counted as cases of infection (wu et al. ) . in belgium, deaths were counted independent of any testing (schultz ) . of % of all deaths, only . % turned out to be confirmed by laboratory test as covid- positive. almost half of all victims were merely suspected to be linked with the virus but had never actually been tested. there was and remains no agreement among experts and officials on what counts as a death caused by the virus. in italy, covid- -related deaths were defined as those occurring in test-positive patients, "independently from preexisting diseases that may have caused death" (onder et al. ) . this is particularly concerning in terms of data quality because the vast majority of deaths occur in patients who are older than with one or more comorbidity. test-positive patients who die because of heart disease or terminal cancer are not necessarily dying because of sars-cov- infection. yet they appear in the statistics of some countries. this confusion between patients who die with the virus and those who die from it has had an impact on the data and their quality, making comparisons between countries impossible. further, almost all tests that are done use rna tests, which can detect an infection only as long as the virus is present in the body. these tests, however, cannot tell whether a person had the virus in the past. only serological tests for antibodies against the virus can provide an accurate picture of how many people have been infected in a given population. and yet, such systematic serological studies were and are missing. given the lack of testing and taking into account the role of selection bias, the large number of asymptomatic cases, the confusions in case definitions, the changes in testing policies, and the difficulty of knowing who is dying with versus dying from the disease, the denominator for calculating actual death rates cannot be reliably determined. without a denominator, it is mathematically impossible to calculate the case-fatality rate. nevertheless, despite the lack of data, experts, officials, and the media have remained transfixed by the assumption of clarity and reliability of numbers, and they continued to circulate wild estimates, unleashing a pandemic of scary charts with exponential curves. over the last weeks of march, more and more testing was done globally, and more testing continues as of the time of this publication. not surprisingly, estimates of the case-fatality rate have come down significantly, because the denominator has gone up due to the increase of testing. in iceland, % of the population has been tested using rt-pcr-based tests independent of symptoms, suggesting a case-fatality rate of . %. this figure is six times lower than who's official estimate for covid- . the center for evidence-based medicine at the university of oxford noted that if one assumes that % of iceland's population is infected, then the corresponding infection-fatality rate would be . %. a study using both rt-pcr-based and serological tests conducted in one of germany's most affected regions indicated a case-fatality rate of . % and an infection-fatality rate of . % (streeck et al. ) . we know from epidemics and pandemics of the past that the case-fatality rate is often massively overestimated at the beginning of an outbreak because case detection is limited, largely based on hospital patients and typically biased toward the severest cases of disease. when the h n swine flu pandemic occurred in , the estimated case-fatality rate varied between . % to . % in the first weeks of the outbreak. in , a decade after the pandemic, the who reported that the swine flu pandemic turned out to have a case-fatality rate of . %. this means that the actual casefatality rate was five times lower than the lowest estimate. social science scholarship has shown how numbers can deceive. numbers have the ability to reveal as well as conceal. therein lies their magic. they appear as seemingly neutral bearers of truth. they offer a sense of mathematical precision, making things seem more certain than they actually are and displacing attention away from the conditions under which they were produced. abstracting from limitations on the conditions of their production and treating numbers as absolute is dangerous because it makes things comparable that are not comparable, because it suggests scientific knowledge where there is lack of evidence, and because it creates the sense of a major threat obscuring the differential nature of risk. what using numbers this way fails to account for is the fact that not everyone is at risk in the same way. among the more interesting figures of the sars-cov- pandemic is the number of deaths per million inhabitants per country. this number is probably more reliable than the case-fatality rate because deaths are less likely to be missed (ignoring for now the case of belgium and the difficulty of defining deaths caused by sars-cov- ) and because the denominator, a country's population, is known. here are the current numbers of deaths per million inhabitants for five countries as of may , : spain: italy: france: germany: south korea: the staggering differences between countries cannot solely be explained by demography or rates of infection (some countries seem to have more infected people per million inhabitants than others and so might be overwhelmed, though this is also a question of time-how many cases per week per region). what the differences might reveal (and it is important to note that they may well change) is that some health care systems are able to deal with the crisis in a better way than others. the structural fragilities of an underfunded, understaffed, overstretched, and increasingly privatized and fractured health care system contribute to higher mortality rates (adams ) . in a sense, each society has the mortality it deserves (canguilhem : ) . where medical care is easily accessible, with sufficient and well-trained staff, and with capacity flexibility, patients are more likely to receive better care and survive. in this sense, it matters that spain turns out to have beds per , inhabitants, italy . , france , germany , and south korea . . although beds per inhabitants is a crude indicator, it is noteworthy that germany can rely on over , staffed intensive care beds, out of which only , were occupied in early april (see mohr and datan-grajewski ) . this at a time when there were more cases in germany than in france and the united kingdom and slightly less than in spain and italy. germany's was clearly not a health care system overwhelmed by a sudden surge of patients. ironically, organizations such as the oecd frequently scolded germany's health care system in the past for "oversupply" of hospital beds and its "inability" to "rationalize hospital capacity" (kumar and schoenstein ) . this means that the case-fatality rate is not just dependent on the biological nature of the virus and the age and health profile of the population (people most at risk of death are older than with one or more comorbidity). the case-fatality rate also depends on systematic testing, meticulous contact tracing, well-trained health care workers, nursing homes with adequate resources, and the ability of the health care system to cope with the crisis (excess as well as surge capacity) and provide high-quality medical care, particularly keeping medical workers safe and healthy. in this sense, the pandemic has and will continue to brutally expose policy failures and structural health care system deficits. the situation in many hospitals in italy, spain, and france is troubling, especially in densely populated areas. but it is important to understand why some of these highly visible institutions of care were overwhelmed. lombardy, italy's most affected region, has long been an experimental site for health care privatization: community-centered care "has been all but wiped out" (bagnato ) . the lack of general practitioners and the defunding and low emphasis on community care have increased the pressure on hospitals in urban centers. these hospitals have neither excess nor surge capacity to cope with a sudden rise in demand. over the past five years, hospitals across europe held numerous strike actions "with doctors and health workers complaining of funding cuts, a government reduction in the number of beds and a serious lack of medical staff leading to dire working conditions for emergency room staff" (chrisafis ). hospital systems in italy, spain, and france were on the brink of collapse even before the virus arrived. the most telling demonstration of the structural contradictions of pandemic preparedness under neoliberalism occurred, not surprisingly, in the united states. as american newspaper articles reported, hospitals across the country deferred regular medical services to free up space, equipment, and staff for the pandemic response. when patients started to avoid hospitals due to fear of infection, a main source of income was drastically cut off, "causing huge losses that have forced some hospitals to let go of health care workers as they struggle to treat infected patients" (harris and schneider ). facing a "financial nightmare," hospitals filled their intensive care units with patients who did not really need intensive care so that they could charge more and make up for the financial loss. additionally, administrators cut salaries, laid off hundreds of staff, and sent others on unpaid leave, weakening the health care system further in the midst of the pandemic response. when a new virus appears, things start to fall apart. once everyone gets scared, extreme measures are implemented, in a more or less improvised manner, and trillions of dollars, euros, and pounds are pumped into the economy to make up for the loss. once the worst is over, however, the normal crisis continues, and the structural fragilities remain (caduff ) . this pandemic will haunt us all for decades in ways that we can barely imagine at this point. the nature and sheer scale of the interventions that we have witnessed are staggering, and the consequences-social, political, and economic-remain unforeseeable. there are no systematic accounts of the implications and repercussions seen so far, nor do we have any idea about the number of indirect deaths due to the lockdowns/curfews, the social distancing and the self-isolation. we have yet to see a realistic plan that would outline how we might learn to live with a virus that is unlikely to disappear any time soon (sullivan and chalkidou ) . in the meantime, i suggest that we reframe the corona conversation to cut through the confusion and dimness that is pervading this pandemic in the following ways: the emergence of new viruses in human populations is normal. it has happened before; it will happen again. coronaviruses are common and circulate widely in humans. they have infected people and killed thousands year after year, especially in winter. worldwide, between , to , people die from influenza viruses every year. the sars-cov- virus has killed , people so far. there is no doubt, sars-cov- is causing a serious infectious disease, but so far it is still in the range of what we observe in terms of mortality during a severe influenza season. the main difference is the speed of infection, the clinical picture of the disease, and the impact on demographically older populations causing massive compression of morbidity and mortality that is overwhelming weak health care systems with no excess and little surge capacity. the influenza pandemic killed between and million people worldwide, and the influenza pandemic killed between and million people. as of the writing of this article, covid- has killed , people, according to the official numbers. clearly, the world has witnessed worse pandemics, including . million deaths due to tb each year, , deaths due to hiv infections each year, and , deaths due to malaria, all preventable and treatable conditions. this observation does not mean that influenza and covid- are clinically similar or that nothing should be done to contain the spread of sars-cov- and mitigate the consequences. however, it raises the question of why fear and panic are spreading like wildfire, provoking such extreme measures, and why experts and government officials are willing to mount an unprecedented effort for sars-cov- but have never considered similar interventions for the , - , people who die every year due to influenza. influenza is a relatively well-known virus. to say that sars-cov- is an unknown virus doesn't automatically justify the most extreme measures that the world has ever seen. what makes this pandemic unprecedented is not the virus but the response to it. extreme measures to contain the spread of the virus have resulted in extreme fallouts. it is difficult to overestimate what we are witnessing today. the pandemic response has pushed the world into a space of fragility and uncertainty. there hovers a "perhaps" over everything now (caduff ) . blinded by the urgency of the immediate moment, the response has created an opening for actors and institutions to push agendas and reorder the world. we will grapple for years to come with the changes that are happening today. the response to the disease is driven by a fantasy of control that overestimates and overreacts. this fantasy has caused and is causing enormous harm. it is unrealistic, misleading, and bound to fail. a pandemic like this cannot be controlled; it can only be managed. if we keep using words such as control, we are only setting ourselves up for disappointment. this pandemic is far from having found a language that is adequate to the problems it is posing. we urgently need new concepts but seem to have little imagination. the urgency of the crisis has displaced reliance on basic standards for quality and control of quality of scientific research. papers are published without peer review. claims are made without evidence. perhaps not surprisingly, given the fragile health care infrastructures in some countries, speed appears to be more important than quality, rigor, and integrity. underscrutinized science, lack of data, speculative evidence, strong opinions, deliberate misinformation, exaggerated mortality rates, the / news media attention, and the rapid spread of dramatic stories on social media have led to poor political choices and major public anxiety. we are afraid of covid- . we are not afraid of influenza. we see one thing as a public health emergency and another as a fact of life. today, we are learning an old insight the hard way: not every life and not every death are equal. some deaths are more important than others, drawing more attention, triggering a bigger response and mobilizing more resources. in the covid- pandemic, the belief seems to have taken root that health is an absolute value and that every life needs to be saved by all means. meanwhile, millions of people are dying of influenza, tb, hiv, malaria, and diarrhea, not to mention chronic diseases and accidents. there seems to be less political urgency for these preventable deaths. some health care systems were overwhelmed in this pandemic. others were not. for decades, governments have underfunded, understaffed, and privatized health care systems across the world, and these trends have exacerbated the impact of the pandemic. the response to sars-cov- took a particular shape, converging in extreme measures that have become the norm in many countries. questions that remain include: was it the only possible way of managing the crisis? why has a crude version of china's approach become the dominant model? at the heart of this pandemic was and is the widespread assumption that there were and are no alternatives to extreme measures implemented on entire populations with little consideration of cost and consequences. this is not true. as some countries have shown, adequate testing and less drastic policies of social distancing work well to manage the pandemic. it seems that some officials saw covid- as a disease that could be contained. as the who director-general suggested in early march , "we don't even talk about containment for seasonal flu-it's just not possible. but it is possible for covid- ." this perception may have contributed to the radically different approach seen across many countries. the idea of "flattening the curve" is often seen as the optimal solution, but there is no guarantee that the effort to do this will actually impact the total number of deaths over the long run of the disease's presence in any community. it may ultimately simply spread the same number of deaths over a longer period of time and thus perhaps reduce the pressure on hospitals but not overall mortality. nationwide lockdowns are not a solution. they prevent infection as long as they are in place, but they also keep people susceptible. this is particularly concerning in a pandemic where the virus has become endemic. once lockdowns are lifted, the number of infected people may well rise again later. this is why it has been so hard for countries who adopted this strategy to return to normal life-the strategy is not sustainable over the long run. as andrea bagnato noted about the stay-at-home strategy: "it is not in the harshness of its lockdown, but in the effectivity of separating the infected from the non-infected, that china's response has excelled: a centralized system of dedicated structures (called fangcang) was built in no time, where all patients and their contacts were treated and divided in four groups according to severity. instead, lombardy simply closed everything down. and it becomes clearer by the day that the main landscapes of infection were not public spaces, but hospitals, retirement homes, workplaces, and indeed private homes" (bagnato ). in germany, % of the people who died due to covid- are years or older (mohr and datan-grajewski ) . a majority of the patients who died have one or more underlying health condition such as hypertension, diabetes, cardiovascular disease, chronic respiratory disease, or cancer. this means that the pandemic is killing predominantly people with an already reduced life expectancy. the key question then becomes excess deaths-the difference between the statistically expected number of deaths and actually occurring deaths over a period of time. there is no doubt that there will be excess deaths due to covid- , but it is unclear how large that number will be. the pandemic response has produced a substantial rise in the number of people who now live with untreated illness. prohibition of public transport has made it difficult for patients and staff to reach hospitals. patients with conditions other than covid- avoid doctors because they are afraid of getting infected. emergency room attendance dropped substantively the world over. cancer referrals decreased and cancer screening services stopped entirely. rural health services in countries such as india crashed. essential public health programs have been paused; many resources have been reallocated. this means that patients are neglected, receiving no or less medical care, leading to untreated illness and a rise in mortality. a virus causes disease, not hunger. it is not the pandemic, but the response to it that threatens the livelihood of millions of people. in many countries, both rich and poor, the trends are shocking. in india, children die of starvation. farmers commit suicide because they are unable to harvest crops. stranded daily wage laborers drop dead after walking hundreds of miles. the poor, marginalized, and vulnerable bear the brunt of the pandemic response. the lockdown is a political mechanism not simply for the prevention but for the redistribution of negative effects. lockdowns shift negative effects away from hotspots of public attention to places where they are less visible and presumably less serious. in this way, they are part and parcel of a politics of inequality. this pandemic is not just about health, it is about fear, and the objects that are singled out and then made the ground and motivation of systematic thought and action. to be afraid has become an obligation, a responsibility, a duty. people are afraid not just because of what they experience but because they are told to be afraid and encouraged to inhabit the world with fear of "foreign bodies" and "invisible enemies." public discourse is highly moralized. looking for someone to blame, individuals are exposed as "super-spreaders" responsible for the rising number of cases. on social media, "lockdown warriors" accuse citizens of lack of patriotism and failure to "do their duty" in the face of danger. in this highly moralized public discourse, life is considered an absolute value that can justify almost every form of disciplinary intervention in the name of health. public health needs to be front and center in any infectious disease intervention. investing in strong public health infrastructures should happen even when there is no pandemic. mathematical disease modeling cannot replace systematic epidemiological surveillance on the ground. the most effective way to manage an infectious disease outbreak is to test, trace, and isolate. interventions need to be phased over time; they need to be dynamic, regionally targeted and risk based. all interventions must take into account the social, political, and economic impact, as well as the indirect impact on other health conditions. interventions that do this will create management strategies that work to minimize collateral damage. absolute numbers cannot be used for policy, they only fuel fear and panic. national lockdowns are not a solution. they protect people temporarily, but they also leave them susceptible. once restrictions are lifted, cases of infection are likely to increase again. there is no exit from the pandemic; there is only an exit from the response to it. we are still at an early stage of understanding how best to clinically manage covid- both as a disease and as a risk factor to potentially vulnerable populations. it is vital to find better ways of sharing quality data and effective practice to ensure health systems learn and adapt quickly. what this pandemic shows is a lack of preparedness. this will come as a surprise, given the billions of dollars, euros, and pounds that were spent over the last years on pandemic preparedness, including experience with past epidemics and pandemics such as ebola and swine flu. how can it be that hospitals ran out of n masks in week one? where did all the billions spent on preparedness go? outsourced production capacity and insufficient stockpiles of personal protective equipment put nursing home residents, community health care workers, and hospital staff at risk, weakening health care systems further. key preparedness concepts need to be at the heart of the response. fifteen years of pandemic preparedness seem to have evaporated into thin air in this pandemic. instead of activating existing plans and drawing on concepts such as the pandemic severity assessment framework, countries imposed a massive, untested, and unproven generic lockdown with unforeseeable social, political, and economic repercussions. sars-cov- is less lethal than every single scenario exercise that has been conducted for preparedness planning by governments and non-governmental organizations in europe and america. it will be important to understand why key preparedness concepts were sidelined in this pandemic, despite the attention that preparedness received and the substantial resources it consumed for over a decade. the fear of death is powerful in societies eager to repress the inescapable reality of death. in such a context, it is important to flatten the curve of extreme speaking, feeling, and acting. what was and will always be urgently needed is moderation and perspective. to continue to engage in today's competition for ever more extreme predictions is dangerous. it will only support those who ignored the virus initially and who are more than willing to blame it now for the mess. equally dangerous is a public health populism of clapping hands that leaves out any consideration of the social, political, and economic costs and consequences of sweeping interventions. attempts to obscure political failures are growing rapidly. those who contribute to extreme predictions and apocalyptic readings of the current situation are only contributing to the obfuscation of the policy failures and underlying structural issues that are responsible for many of today's problems. there are already attempts in countries such as the united kingdom and the united states to rewrite failure as success. not surprisingly, governments are calling on citizens to participate in public performances, demonstrate national unity in the face of danger, and celebrate collective strength and resolve. fighter jets soaring through the sky and helicopters showering rose petals on "frontline warriors" are militarized state spectacles. but health care workers deserve more than patriotic feelings and symbolic gestures; they deserve better health care policies. to challenge and critique now is essential. the story of how the chinese approach became a model for generic lockdowns in the global north and then exported to countries in the global south is important to note, particularly considering the dramatic consequences for millions of people struggling to survive without any source of income. ironically, these extremely restrictive lockdowns were sometimes demanded by people eager to criticize the authoritarianism of the chinese state. across the world, the pandemic unleashed authoritarian longings in democratic societies, allowing governments to seize the opportunity, create states of exception and push political agendas. commentators have presented the pandemic as a chance for the west to learn authoritarianism from the east. this pandemic risks teaching people to love power and call for its meticulous application. pandemic time is an auspicious time for all kinds of political projects. as a result of the unforeseeable social, political, and economic consequences of today's sweeping measures, governments across the world have launched record stimulus bills costing trillions of dollars, pounds, pesos, rand, and rupees. earmarked predominantly for individuals and businesses, these historic emergency relief bills are pumping staggering amounts of money into the economy, but, ironically, they are not intended to strengthen the public health infrastructure or improve medical care. the trillions that governments are spending now as stimulus packages surpass even those of the financial crisis and will need to be paid for somehow. today, there is a massive global recession in the making. if austerity policies of the past are at the root of the current crisis with overwhelmed health care systems in some countries, the rapidly rising public debt is creating the perfect conditions for more austerity in the future. the pandemic response will have major implications for the public funding of education, welfare, social security, environment, and health in the future. if you think something good will come out of this crisis, you should think again. today we are just driving faster and with a much bigger car, but it is the same road with the same destination. wolf bukowski notes that the political discussion in italy is now dominated by an "uncritical 'responsibility'" that cannot find a place outside the imperative to contain the virus. "the right intuition that 'we should not question the reality of the epidemic' shifts all too easily into 'we should not question the government's response to the epidemic'" (bukowski ). in such a context, any control intervention imposed by the state is perceived as lawful, and no democratic discussion and debate appears necessary ("let the experts speak!"). in other places, critique has become difficult for other reasons. the tragedy of today's political moment in the united states, the united kingdom, and brazil is that right-wing politicians pushed many into embracing measures that one thought were only possible in authoritarian regimes. here, an engagement in critical analysis has become almost impossible because it is seen as playing into the hands of trump, johnson, and bolsonaro, political figures who seem unconcerned with public health and the staggering inequalities that afflict our world and whose public statements have reached an unmatched level of ignorance and incompetence. however, it is important to understand that the strategic combination of confusion, contradiction, and the play of extreme opposites is foundational for authoritarian rule. everything that instills a sense of disorder and that intensifies the crisis magnifies the desire for decisive action. in this article, i have tried to carve a path through the morass of fear, panic, and desire for control to see how one can sustain a critical analysis of the pandemic response. as scholars and citizens, we have the obligation to think beyond the crisis, create openings in the world, and consider, critically and democratically, how we want to govern ourselves. as veena das underscores, it is important that we do not let our "love for the subtle and nuanced understanding of issues disappear on the grounds of needs for the rough and the ready in an emergency" (das ) . the pandemic and the response to it will require us to reimagine lives, rebuild conditions of existence, and find better ways of doing science and politics. like every engagement in a serious pedagogical project, it will entail a reconsideration of the objects we desire. today's fear is fueled by four main forces: mathematical disease modeling-a flexible and highly adaptable tool for prediction, mixing calculations with speculations, often based on codes that are kept secret and assumptions that are difficult to scrutinize from the outside. neoliberal policies-systematic disinvestments in public health and medical care that have created fragile systems unable to cope with the crisis. nervous media reporting-an endless stream of information, obsessed with absolute numbers, exploiting the lack of trust in the health care infrastructure and magnifying the fear of collapsing systems. authoritarian longings-a deep desire for sovereign rule, which derives pleasure from destruction and tries to push the world to the edge of collapse so that it can be rebuilt from scratch. this set of forces inspires thought, action, and passion in powerful ways. energized by the thrilling experience of witnessing "history in the making," actors and institutions have seized the opportunity to reorder the world, push political agendas in the name of survival, and shape life for years to come. the pandemic has become an auspicious moment to change the rules of engagement and expand the scope of scientific, medical, and political authority over bodies and populations. it is an occasion to publish papers and make dramatic statements, to feel relevant and important to the world, and enjoy the moment in the limelight. in the midst of death and destruction, the pandemic creates opportunities for innovation, domination, and profit-making. this unexpected opening connects elites in science, politics, and the media, releasing shocks of information, instruction, and command that are pushing hard against our confined, anxious, restless bodies. mathematical disease modeling, neoliberal policies, nervous media, and authoritarian longings fuel a fatal spiral centered around the fear of collapse. this fear is now literally in the air; it moves in and out of us with every breath; it operates as animating medium of our intense isolation and immobility. pandemic fear is unnerving and mentally exhausting. yet for those who embrace the feeling, it has the power of sustaining a state of excitement-excitement derived from the secret pleasure of spoiling a precious thing, wasting enormous resources, and engaging in an all-consuming project with total dedication. what we might call the provocation of the crisis-its intensification, expansion, and totalization beyond any notion of utility-seems so excessive and extreme that it borders on sheer madness. what could be more dangerous, more daring, more exciting than a walk on the wild side, an excursion to the other side of reason? melodramatic phrases such as "beating the virus," "winning the war," and "defeating the darkness" are rhetorically powerful and contagious. equally popular notions like "corona heroes" and "lockdown warriors" are symptoms of overidentification in a hegemonic discourse of power. all these terms reveal how this pandemic is "fabulously textual, through and through," and, at the same time, is lacking a source of symbolization strong, creative, and disturbing enough to move our engagement with the world beyond the most conventional of tropes (derrida ) . the language that we are asked to adopt today, in the midst of this outbreak, is contaminated with words that are stiff, stale, and corrupt like putrid air. given that so much of today's response is based on and driven by mathematical disease modeling and that millions of lives and livelihoods are being destroyed before our eyes, it is not an option anymore to exclude the "externalities" of a pandemic response that lacks imagination and that has resorted to the crudest interventions of all: the full stop. for those with permanent jobs, a comfortable couch, and no daycare duties, this unforeseen interruption may feel like a gift, a welcome relief from the non-stop world of global capitalism. but for millions of people living in less privileged parts of the planet, the pause button spells unemployment and hunger, not breaktime and downtime. without income, food, and access to basic health care, people are not making the most of the confinement outside in the garden; they are desperate and dying. we urgently need to look beyond the virus if we want to understand the real seriousness of what is happening today. how did we end up in this strange space of thinking, acting, and feeling that has normalized extremes and that is based on the assumption that biological life is an absolute value separate from politics? never has it been more important to insist that another politics of life is possible. the latest imperial college disease model report summarizes the staggering blindness that has prevailed in this pandemic: "we do not consider the wider social and economic costs of suppression, which will be high" (walker et al. ) . the time to suppress the costs of suppression and cast the consequences of interventions as an externality to model-based policy is over. these claims are utterly misleading, ignoring the influenza pandemics of and , including the hiv/aids pandemic, ebola, and many other infectious disease outbreaks that have killed millions of people worldwide with no vaccine available. last but not least, the toll of covid- is not even close to the toll of the influenza pandemic. . the report distinguishes between two strategies these days i sometimes catch myself wishing to get the virus-in this way, at least the debilitating uncertainty would be over… a clear sign of how my anxiety is growing is how i relate to sleep. till around a week ago i was eagerly awaiting the evening: finally, i can escape into sleep and forget about the fears of my daily life… now it's almost the opposite: i am afraid to fall asleep since nightmares haunt me in my dreams and awaken me in panic-nightmares about the reality that awaits me disasters and capitalism … and covid- . somatosphere website staying at home. e-flux real estimates of mortality following covid- infection. the lancet coronavirus testing: how some countries got ahead of the rest. the guardian website germany's coronavirus anomaly controllo e autocontrollo sociale ai tempi del covid- the pandemic perhaps: dramatic events in a public culture of danger the normal and the pathological french medics warn health service is on the brink of collapse. the guardian website anger and poverty grip lebanese city. the guardian as covid- pandemic hits india's daily-wage earners hard, some leave city for their home towns. scroll.in website facing covid- : my land of neither hope nor despair no apocalypse, not now impact of non-pharmaceutical interventions (npis) to reduce covid- mortality and health care demand. imperial college website for autocrats and others corona virus is a chance to grab even more power. the new york times website wartime conditions" as global coronavirus deaths reach . the guardian website spread of sars-cov- in the icelandic population cash-starved hospitals and doctor groups cut staff amid pandemic. the washington post bangladesh: end wave of covid- "rumor" arrests. human rights watch website indian doctors evicted over coronavirus transmission fears, says medical body. the wire website, march ebola vaccines, evidentiary charisma and the rise of global health emergency research managing hospital volumes germany and experiences from oecd countries scale of china's wuhan shutdown is believed to be without precedent. the new york times so stark ist die krankenhaus-auslastung mit corona-patienten. mdr website kenya police abuses could undermine coronavirus fight. human rights watch website . case-fatality rate and characteristics of patients dying in relation to covid- in italy china tightens wuhan lockdown in "wartime" battle with coronavirus. the new york times website shows commitment to contain virus: who representation in china. reuters website us unemployment rises another m, bringing total to m since pandemic began. the guardian website india moves big labour law changes to limit coronavirus impact others make these changes. financial express website why belgium's death rate is so high: it counts lots of suspected covid- cases. npr website vorläufiges ergebnis und schlussfolgerungen der covid- case-cluster-study urgent call for an exit plan: the economic and social consequences of response to covid- pandemic. centre for global development website the global impact of covid- and strategies for mitigation and suppression who. . report of the who-china joint mission on coronavirus disease (covid- estimating clinical severity of covid- from the transmission dynamics in wuhan, china is barbarism with a human face our fate? critical inquiry blog stavrianakis, nancy tamini, and laurence tessier. i am particularly grateful for conversations with richard sullivan. maria josé de abreu insisted i start writing and put thoughts on paper. for suggestions, i would like to thank the editor of medical anthropology quarterly, vincanne adams, and the two anonymous reviewers. none of these colleagues and friends are responsible for the arguments in this article. key: cord- - yjj xwv authors: johnson, ian l.; scott, fran e.; byrne, niall p.; macrury, katherine a.; rosenfield, jay title: integration of community health teaching in the undergraduate medicine curriculum at the university of toronto date: - - journal: am j prev med doi: . /j.amepre. . . sha: doc_id: cord_uid: yjj xwv background: in , determinants of community health was introduced at the faculty of medicine, university of toronto. the course spanned all years of the undergraduate curriculum and focused on addressing individual patient and community needs, prevention and population health, and diverse learning contexts. purpose: to demonstrate the value of an integrated, longitudinal approach to the efficiency of delivering a public health curriculum. design: time-series comparing the curricular change over two periods of time. setting/participants: undergraduate medical students from to . intervention: using a spiral curriculum, the educational materials are integrated across all years, based on the concept of medical decision making in a community context. main outcome measures: this study compares measures of student satisfaction and national rankings of the university of toronto with the other canadian medical schools for the “population health, ethical, legal, and organizational aspects of the practice of medicine” component of the medical council of canada qualifying examination part . results: the university of toronto has been ranked either first or second place nationally, in comparison to lower rankings in previous years (p< . on the kruskal–wallis test). student ratings indicated the course was comparable to others in the curriculum. conclusions: for the same amount of curricular time, an integrated spiral curriculum for teaching public health appears to be more effective than traditional approaches. a ttention to teaching medical students about public health has increased in the past few years in both canada and the u.s. examples include the recent changes to the liaison committee on medical education (lcme) accreditation standards which have included the requirement to teach and provide placements relevant to the sciences of public health. major outbreaks such as severe acute respiratory syndrome (sars) and h n have focused attention on the need for a stronger understanding of public health while other documents, such as those produced by the iom and the association of faculties of medicine of canada, have described the need to increase the emphasis of effective teaching in public health and preventive medicine. while there is a strong call for greater teaching, there is a relative dearth of articles that include evaluation of different methods of teaching. at the university of toronto (u of t), the determinants of community health (doch) course incorporated public health education across all years of the medical curriculum. this paper describes the fırst years of experience and evaluation of this course. the purpose is to demonstrate the value of an integrated, longitudinal approach to the effıciency of delivering a public health curriculum. at the u of t in the s, public health was traditionally taught in a didactic manner during the second year of the medical curriculum. during the curricular renewal of , three new courses, two courses called "health, illness, and the community" and one called "determinants of health" were created. health, illness, and the community, taught during the fırst years of medical school, had a strong focus on experiential learning and required students to attend community-based education sessions. , in contrast, the determinants of health course continued with the didactic approach to education, adding tutorial groups in which students worked on problem sets. both courses had been operational for approximately years when a decision was made to integrate the three courses (two from health, illness and the community and one from determinants of health) into doch, which would span all years of the medical curriculum. in , the fırst class of medical students started doch. there were multiple reasons for the creation of this new course, but the creation of a longitudinal integrated curriculum was one of the primary motivations. the format of the new course broke down the preclerkship-clerkship barrier as it was designed as one longitudinal experience, not a combination of two -year experiences. another reason was the dissatisfaction reported by many students. part of this was due to the experiential part of the teaching (in the fırst and second year of health, illness and the community) occurring before the academic, theoretical curriculum of the third-year determinants of health. the time allocation given to the -year doch course was substantial: / day per week in the fırst year; / day per week in the second year; half-days in the third year (just before the students start on the wards); and week in the fourth year (done on a rotational basis with one fıfth of the class being taught approximately every weeks). the doch course was based on a spiral curriculum as developed by bruner. in this model, educational concepts are revisited at increasing levels of complexity across the length of the curriculum. the topics were mapped across the curriculum using the headings of "health and its determinants," "science of population health," "working as a team in the community," and "practical application." this framework is shown in table . the focus in the fırst year is on defınitions of health, the determinants of health, description of the healthcare system, role of community agencies, health promotion, and health protection. in the second year, students complete an independent research project. in the third year, the main concepts are evidence-based medicine, quality improvement, patient safety, outbreak management, and legal aspects of medicine. the fourth year is the capstone week that brings all these concepts together after the students have had a year of clinical ward experiences. table shows more details on the individual courses taught in each year of study. epidemiology provides an example of the application of the spiral curriculum: descriptive epidemiology is taught in the fırst year, analytic epidemiology in the second year, and clinical epidemiology in the third and fourth years. similarly, for being able to work effectively in the healthcare system, the basic structure of the healthcare system is taught in the fırst year; students work on a project in the second year that may involve some discussion of the organization of community-based services; quality improvement and patient safety are taught in the third year; and physician supply and payment systems are taught in the fourth year. for this latter concept, the discussion in the fourth year looks at the evidence of how physician payment systems may affect the quality of patient care. the evaluation of the course focused on two major areas. since student dissatisfaction was one of the reasons for creating doch, student satisfaction scores were used as one of the main outcome measures. the standard student rating system was used for assess- ing lectures, seminars, tutorial sessions, and fıeld visits. this system is a likert-type scale, with a score of indicating that the session was "not at all helpful"; a score of is neutral; and a score of indicates that the session was "extremely helpful." while these scores are ordinal in nature, average scores are provided as a means of giving one summary measure for each education session. for more objective outcome measures of knowledge, a timeseries analysis was done, using the average scores and school rankings from the population health, ethics, legal, and organizational the doch course has been successfully run since , with the fırst class graduating in . in terms of subjective student satisfaction, the evaluation of lectures and tutorials are equivalent to those of other courses taught in the medical school. clinically related sessions, such as visits with nonmedical health professionals to people re-ceiving care in their home, are very popular. on the other hand, similar sessions on public health where students visit a school and assess the health of a population of school children are slightly lower (table ) . overall, lectures delivered by patients or members of the community (e.g., a drug addict presenting on the heroin replacement program) had the highest ratings, followed by community visits. the sessions with the lowest rankings are those in the second year when students are expected to do a fair amount of individual work. in terms of the rankings of all courses, the fırst and fourth years were the most popular, followed by the third year and then the second year. in terms of the objective data from the phelo/ph/ pmch scores on the mccqe exam, figure gives the ranking of the u of t compared to the average of the other medical schools in canada. in the - period (didactic teaching in the second year of the medical school) the u of t had a relatively poor ranking. at this time, the average scores for u of t graduates were lower than the overall average of graduates from canadian medical schools. with the advent in of health, illness, and the community, and determinants of health ( years after the course started in ), the ranking of u of t relative to the other schools improved to nd place. however, the ranking slowly fell over time and approached the canadian average. after the change to doch, the students graduated in and the ranking of the u of t program improved to number , indicating that students were doing substantially better. unlike the previous period, this better ranking was sustained over time the results of these indicators should be considered in two ways. first, the improvement in the ranking and increase in the average score of u of t graduates relative to those of all canadian graduates was accomplished with no change in the amount of curricular time. the total number of educational hours offered in the health, illness, and the community/determinants of health curriculum was the same as that of the doch curriculum. the essential difference was the organization of the material into a longitudinal curriculum and a change in the timing of the course (moving week from the third year to the fourth year of the curriculum). the other comparison is between u of t and the other medical schools. during this time, no other canadian medical school used a longitudinal curriculum. taken together, these results indicate the relative effectiveness of teaching public health in a longitudinal fashion. the use of a longitudinal curriculum has helped to keep the course focused. there was one overall course planning committee and one course director who was responsible for the curriculum planning and delivery of all years. the course planning committee had student representatives from all years. since many curricular topics have a community health component, there has been a strong pressure to keep adding more and more topics to the doch course, particularly those that did not fıt well with the other courses being offered. the spiral curriculum provided a framework perceived value of oral presentation . perception that the material learned in doch will be useful in future practice for assessing these potential new components relative to the student learning objectives. in many instances, the new components were rejected or moved to another time due to this incompatibility. for example, the suggestion of teaching how to interview patients with disabilities living in the community was felt to fıt with the clinical skills course. the inclusion of such material would have lead to potential confusion among the students about the core content of public health. the student satisfaction scores were used in planning class activities and to increase the student appeal of the course. the examples shown in table were chosen as they were typical of the student evaluations over the years. as can be seen, the fırst-year community fıeld visits ranked extremely high. on the other hand, the values for the second year were lower. the latter were interpreted to be due to the fact that the lectures on research methodology were general in nature and the students had to apply material to their individual project. based on these evaluation scores, more relevant speakers were identifıed and other educational resources were developed, such as web-based modules to help students with specifıc educational needs (e.g., many students conduct surveys, so a module on survey research was added). a second reason for the lower scores is that secondyear students have to take an active role in engaging with the sponsoring agencies to complete their projects. there are a number of major limitations to this study. first, the research design does not allow for the authors to control for other factors that could have occurred at this same time. due to the nature of the medical school class, the entire class had to follow one curriculum so that no comparison group was temporally available. second, the phelo component of the mccqe exam does cover most of the areas being taught by the doch course. however, it does not cover everything. topics such as immunization schedules and many aspects of clinical prevention are taught in other sessions, outside of the doch course, and thus they were not taught in the longitudinal curriculum. the use of a spiral curriculum with integration of public health content across all years appears to be more effec-tive than traditional teaching methods. the course was acceptable to the students and resulted in higher scores on objective assessments of clinical knowledge used in canada. publication of this article was supported by the cdc-aamc (association of american medical colleges) cooperative agreement number u cd . no fınancial disclosures were reported by the authors of this paper. functions and structure of a medical school: standards for accreditation of medical education programs leading to the m learning from sars: renewal of public health in canada the h n pandemic-how ontario fared: report by ontario's chief medical offıcer of health improving medical education: enhancing the behavioural and social science content of medical school curricula. www.iom.edu/ ϳ/media/files/report% files/ /improving-medical-education-enhancing-the-behavioral-and-social-science-content-of association of faculties of medicine of canada. future of medical education in canada (fmec): a collective vision for md education the social contract challenge in medical education creating community agency placements for undergraduate medical education: a program description the process of education quality monitor: report on ontario's health system biostatistics: the bare essentials version . . key: cord- -nkrw sad authors: khosla, rajat; allotey, pascale; gruskin, sofia title: global health and human rights for a postpandemic world date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: nkrw sad nan historically, pandemics have forced humans to break with the past and imagine their world anew. this one is no different. it is a portal, a gateway between one world and the next. -arundhati roy inspired by these words, we try to imagine 'another world'; one which puts everyone's health and human rights at the centre. for us to do that, we need to start with introspection about the world we wish to leave behind and ask ourselves some tough questions. for we, those working on health and human rights in global spaces and beyond, need to reflect on our values, our standards, our institutions, our mechanisms, and ask if we are fit for purpose. can we seize this opportunity to rebuild anew, without first taking a mirror to the sheer savagery of the injustice on display around the world-and our role in it? the obvious answer is-no. unless we realign our values, we risk dragging 'the carcasses of our prejudice and hatred' into the new world. with the waning of, or growing ennui from the shock of the pandemic, the world seems ready to slip back into 'avarice' with little thought. the reversal of the temporary but refreshing drop in carbon dioxide levels is evident, as is the greed of big pharma, and the onslaught on the global commons. are we going to continue with the absurdity of our present or '…walk through lightly, with little luggage, ready to imagine another world'? in the who constitution, world leaders proclaimed 'the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.' the true meaning and purpose of this statement while never fully realised have never seemed more distant. it took just a few weeks of the covid- pandemic for the gains of decades to begin to erode. in the past months, millions have been pushed back into poverty; catastrophic consequences have been borne by the elderly; women and girls have suffered unspeakable levels of violence and been denied essential services, and we are witnessing what could well be a lost generation of children. all of which is needless and all of which was preventable. the question, therefore, is how did it all go so horribly wrong? over the last several decades, there have been significant, though uneven, advances in recognising health as a human right. addressing discrimination and inequality have largely been accepted as critical for people to attain and maintain their human rights to health. there is a general acknowledgement, at least discursively, that an individual's ability to manifest their human rights has a direct bearing on their health and vice versa. consequently, there have been significant strides in the development of normative aspects, on a range of global health topics, as well as tools for monitoring health from a human rights perspective. these advances have, however, been paralleled by regressive tendencies. the operationalisation of health within countries is often undermined by arguments that the specificities of national contexts justify the abdication of human rights responsibilities, resulting in policy incoherence and uneven implementation of international norms and standards. macrolevel politics and ruling ideologies have had profound impacts on the provision of services, and ultimately individual realisation of health. patterns of financing and funding for global health significantly determine not only normative developments but the implementation of interventions on the ground. global health work continues to pay lip service to human rights in setting global and national development priorities. yet the structures do not embrace health as a human right, as intrinsic to the capability of individuals to achieve a life they value. in failing to embrace what human rights offer, we lean towards simplistic solutions to otherwise complex bmj global health global health issues, rooted deeply in social, cultural, religious contexts. covid- is a stark example of this failure, both in the events leading up to the pandemic as well as in the responses. but covid- is not unique in revealing an ecology of sickness and mortality based on social determinants of health. failing to explicitly address human rights concerns not only continues to jeopardise the response to this pandemic, but the future of global health. the time is now to rethink health as a human right, that is premised not just on our collective conscience, but our collective responsibility. to rethink global health, we have to start by reimagining health as a 'global common'. so much of our world is premised on the notion of the individual that we have trouble understanding that some of the most crucial wealth we own is collective and social. many scholarly writings, reflecting on the determinants of the current pandemic, point to our failure to approach global health as 'commons' as the beginning of our collective descent. market structures and capitalistic models of development which justified everything, from fracking to unfathomable use of fossil fuels, to the systemic perpetuation of inequities, have systematically unravelled the concept of the 'commons'. add to that the abandonment of global leadership and the withering trust of populations in political leaders, the very glue that might have held the commons together, has been relinquished. sad as this may be, it is not new. for at least a generation, the archetype of 'commons' has been tainted by the narrative that it is invariably a tragedy. this view argues that commons would fall apart, as eventual overuse would destroy the resource. the pandemic, and the litany of failures that led to it, is evident. this pessimism may persist, in part, because the notion of the commons is frequently confused with an open-access regime, in which a resource is essentially open to everyone without restriction. therefore, without the 'social infrastructure' that defines the commons-the cultural institutions, norms and traditions-the only apparent value left is private profit for the most aggressive appropriators without any incentive to invest in the resource because someone else may gain from the returns. the same is true for global health. healthcare systems are held and managed under different property regimes, often with complete disregard of the basic tenet, that global health foremost is a 'global common right' and healthcare systems a 'common pool resource'. as we strive to create another world, we must start by challenging how we understand 'commons', and build a narrative for the collective, recognising the power of exogenous variables such as moral and social norms, and the significance of the commons to those who do not hold the strings of power. equally importantly, we must rebuild public trust, because it is not just addressing the pandemic that is at stake, but the whole future of global health. to ensure we are fit for purpose for a new world, we need to take a deeper look at our institutions, our mechanisms. the questions that arise are not about a single institution or mechanism, but about multilateralism as a whole, and about the member states who are the 'masters' of these institutions and the bedrock on which multilateralism is premised. the history of the united nations (un), and the league of nations that preceded it, provides critical context. many blame the failure of the league of nations, on general weaknesses within the organisation, such as the voting structure, and incomplete representation among world nations. the league was also paralysed by the absence of the usa, already a significant power. as paradoxical as it may be, the same pivotal country is now systematically disengaging from multilateral institutions and agreements. the situation for the un today, however, is more complicated. not only is this a time of rising nationalistic demagogues as leaders, with narratives restricted to 'me' first; the system also struggles with structural weaknesses, block politics and a voting structure which privileges certain countries over others. member states can rightly be criticised for reducing the un to a fig leaf that they hide behind, but also a whipping mule. despite rallying calls for global solidarity, as covid- has shown, we are not all in this together. siloed and isolated positions do not work. no one is insulated, and no issues are unconnected. the pandemic has brought into sharp focus the interconnectedness, the indivisibility and inalienability of the human rights agenda from the global health, global development and global peace agendas. time is now to show real leadership, seize the opportunity and bring these agendas together to deliver a truly sustainable future, one that truly leaves no one behind. the need for an in-depth review of these institutions today is more acute than ever because the way we strengthen and reshape them will not only determine our collective future but that of generations to come. for any such review to be genuinely transformative, however, it must start with a review of the member states and their conduct domestically and within these institutions. john locke explained the notion of the social contract as one 'where people in the state of nature conditionally transfer some of their rights to the government to better ensure the stable, comfortable enjoyment of their lives, liberty, and property'. the pandemic has shown people around the world willing to give extreme deference to the state and readily accepting severe restrictions to their freedom of movement for weeks and months at bmj global health a time. however, hundreds and thousands of lives have been lost, sometimes because of authoritarian leadership and their inability to accept scientific evidence and willingly subject people to needless suffering and death. the question becomes, therefore: is the current social contract tenable? from the grass roots to the national to the global level, as governments fail to provide 'stable, comfortable enjoyment of their lives, liberty, and property', this question is now universal. as the elite went into their burrows and hid for months largely unscathed, the 'common person' not only bore the burden as 'essential workers' but many died needlessly. the demand for an equal social contract premised on the fundamental values of human rights for all human beings, equal participation and voice and not deference, is required. we need collectively to answer the question: is it time to renegotiate the social contract? the stakes are high, and we cannot afford to get it wrong. we go back to our original question: are we ready to imagine a new world? to answer yes, we must first fathom the courage to 'shed the baggage', the prejudices of the past and reimagine a narrative which puts our collective health and human rights at the centre. through this essay, we hope to initiate a discussion that can help us build back for the better. in the words of jonathan mann, 'time is now for us to come together as "equal partners in the belief that the world can change".' twitter pascale allotey @pascaleallotey contributors the manuscript is a result of discussions towards foundational work on the future of human rights in health. the initial draft was written by rk and subsequent versions jointly developed with contributions from pa and sg. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. competing interests none declared. patient consent for publication not required. provenance and peer review not commissioned; internally peer reviewed. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. pascale allotey http:// orcid. org/ - - - the pandemic is a portal world health organization. constitution of the world health organization. basic documents, forty-firth edition supplement global commission on hiv and the law. risks, rights and health leading the realization of human rights to health and through health: report of the high-level working group on the health and human rights of women, children and adolescents interpreting the international right to health in a human rights-based approach to health health and human rights at a crossroads building a transformative agenda for accountability in srhr: lessons learned from srhr and accountability literatures capability and well-being addressing human rights as key to the covid- : response silent theft: the private plunder of our common wealth the tragedy of the commons whose common future: reclaiming the commons health care as commons: an indigenous approach to universal health coverage second treatise of government health and human rights: a reader key: cord- - w car authors: hare, nathan; bansal, priya; bajowala, sakina s.; abramson, stuart l.; chervinskiy, sheva; corriel, robert; hauswirth, david w.; kakumanu, sujani; mehta, reena; rashid, quratulain; rupp, michael r.; shih, jennifer; mosnaim, giselle s. title: covid- : unmasking telemedicine. date: - - journal: j allergy clin immunol pract doi: . /j.jaip. . . sha: doc_id: cord_uid: w car abstract telemedicine adoption has rapidly accelerated since the onset of the covid- pandemic. telemedicine provides increased access to medical care and helps to mitigate risk by conserving personal protective equipment and providing for social/physical distancing in order to continue to treat patients with a variety of allergic and immunologic conditions. during this time, many allergy and immunology clinicians have needed to adopt telemedicine expeditiously in their practices while studying the complex and variable issues surrounding its regulation and reimbursement. some concerns have been temporarily alleviated since march to aid with patient care in the setting of covid- . other changes are ongoing at the time of this publication. members of the telemedicine work group in the american academy of allergy, asthma & immunology (aaaai) completed a telemedicine literature review of online and pub med resources through may , to detail pre-covid- telemedicine knowledge and outline up to date telemedicine material. this work group report was developed to provide guidance to allergy/immunology clinicians as they navigate the swiftly evolving telemedicine landscape. the covid- pandemic led to an unprecedented change in clinical operations, motivating physicians and healthcare systems worldwide to rapidly implement telemedicine programs to reduce or replace in-person visits. telemedicine has allowed for increased workforce sustainability, limitation of clinician direct exposure to patients, overall reduction of personal protective equipment (ppe) use, and may reduce clinician burnout. it has also facilitated staffing of both large and small facilities that are overwhelmed with pandemic-related patient overload. in addition, telemedicine has been used for surge control or "forward triage" -the triaging of patients before they arrive in the emergency department (ed). direct-to-consumer (dtc) visits have allowed patients to be efficiently screened while protecting patients, clinicians, and the community from exposure. this rapid need for telemedicine visits has generated the demand to effectively educate allergists/immunologists on how to optimize utilization. prior to the pandemic, telemedicine was often reserved for patients with decreased access to care. it is quickly becoming the preferred mode of delivering care for both follow-up and new clinic patients. , recognizing telemedicine as a growing field for the practicing allergist/immunologist, the american academy of allergy, asthma and immunology (aaaai) health informatics, technology and education (hite) committee established a telemedicine work group (twg) to review multiple aspects of telemedicine including utility, adoption procedures, billing, security, electronic medical record (emr) integration, education, and state specific issues. traditional rationale for telemedicine: convenience of care, increased access, and cost telemedicine has been shown to decrease costs of travel for patients in both time and money. by making it more convenient for them to obtain care, telemedicine has increased access for patients who might not otherwise be able to receive care or be seen at a given practice. , prior to the covid- pandemic, patients who may have benefited from telemedicine included poor, elderly or disabled patients, or those who simply lived too far away to travel for an in- person visit. telemedicine is well-suited to large rural states or medically underserved urban areas. a study found that telemedicine in the veteran's health administration (vha) has likely improved access to care for veterans who live in rural areas. this convenience is also applicable in emergency and hospital settings where specialists may not be on site. virtual consultations can limit the need for transportation of ed patients to other facilities for care and hospital transfers. , as early as , estimates predicted that teleconsultations could obviate the need for up to , transfers and save us$ million dollars per year. a retrospective study done in the vha looking at data from - found that, for the clinics studied, the mean no-show rate for doctor appointments was . %. the average cost of a no-show visit in the vha in was us$ . telemedicine may help improve patient compliance and decrease the associated financial cost to practices and clinicians of no-show visits by reducing barriers to care. cost-benefit analysis data for the use of telemedicine is minimal at this time. however, recent studies conducted in tele-dermatology and telemedicine in the pre-hospital care setting have recently shown promising results. , despite the exponential growth of telemedicine in the past five years in the united states, the adoption of these services by the allergist/immunologist community was minimal prior to the pandemic . several factors contribute to the rationale for growth of telemedicine during the covid- pandemic. first, the public health emergency (phe) has led to the development of guidelines for quarantine as well as for social and physical distancing . steps involved in starting a telemedicine program the first step in setting up a telemedicine program is determining the types of patients that will be seen. assuming that federal, state, malpractice, and insurance guidelines are taken into account, these may include initial consultations, established visits, and patients at a distance. it is important to know the limitations of telemedicine, as there are certain visits that can be challenging to perform through telemedicine. procedures and procedure-related visits, such as allergy skin tests, immunotherapy and/or biologic injections, food and/or drug challenges, in general are difficult to accomplish except in the case of a facilitated visit where a trained clinician is present at the patient's site who is adequately trained and is able to accept responsibility for treating the patient if a systemic allergic reaction occurs. the next step is to decide whether the telemedicine visits will be through a synchronous or asynchronous approach. asynchronous telemedicine is communication with a patient separated by distance and time. synchronous telemedicine is where the clinician and patient are connected at the same time in a live interactive audiovisual exchange. synchronous telemedicine is further classified into direct-to-consumer (dtc) visits or facilitated visits (fv). a direct-to-consumer (dtc) visit occurs between the patient and clinician at a non- medical facility, such as the home, where communication is directly through the patient's smartphone or computer. a facilitated visit (fv) requires a facilitator to operate equipment and guide the patient through the video visit. the equipment needed at the origination (patient) site depends on whether the appointment is a facilitated visit (fv), a dtc visit, or a telephone visit. please refer to the online supplement for specific technology guidelines. for a fv, there should be a specific room in which the patient can be seen (often a regular examination room). most origination sites have a "telemedicine cart", which contains the hardware, software and other equipment needed for a telemedicine with the patient, establishing their role and connection with the patient is recommended. once the platform and equipment are in place, the next step is to organize the scheduling of patients. guidelines for patients best suited for telemedicine should be established. pre-clinic huddles can be effective forums for identifying patients suitable for telemedicine visits. initially, consider scheduling the same amount of time for a telemedicine visit as an in-person visit to allow a buffer for technology issues that may come up. documentation in the emr can be done at the same time as talking to the patient. the scheduling of telemedicine visits among in- person visits depends on practice efficiency, notification system, and workflow. this can be adjusted as needed. one important aspect to developing a successful telemedicine program is adequate training. software. if that fails, one may have a backup, encrypted independent platform. if the first two encrypted options fail, traditional phone modalities may be used (see tables ia and ib for examples of encrypted and non-encrypted telemedicine platforms, respectively). flexibility and versatility in dealing with technology failures in real time is paramount. providing checklists or a toolkit for patients that include educational handouts on the patient's expectations, an introduction to the consent process, how to contact information technology if they encounter difficulties during the visit, and how the patient can prepare to ensure a stable digital connection during the visit is essential. online tools including podcasts and webinars can offer clinicians multiple medical education modalities. please see table ii (online resources for telemedicine). clinic schedulers and other staff should contact patients prior to the visit to discuss preparation for their telemedicine visit. included in this discussion should be a review of the devices (computer with camera, smartphone, phones, digital tablets) that can be used for the remote telemedicine encounter. in addition, test calls with the device are recommended to ensure the patient will be able to reliably connect to the clinician for their telemedicine visit. depending on the platform and the healthcare system involved, consent, required by most states, may be obtained by the clinic staff or clinician and documented prior to the visit. even if obtaining a patient consent for telemedicine visits is not required in a particular state, it is an advisable best practice to implement in telemedicine. a telemedicine visit starts when the patient logs into the telemedicine site. some emrs have an integrated telemedicine application, thereby eliminating the need for a separate telemedicine application. however, this is not a requirement; the telemedicine and emr applications do not have to be linked. once a connection with the patient has been established and consent obtained, the encounter can start. it may be helpful to have the patient's chart in the emr open, either on the same screen or on a separate screen, to refer to and facilitate documentation during the visit. the clinician may want to discuss what to do if the call drops or internet access is disrupted with the patient at the start. documenting information from the patient as to their current location and phone number is recommended as it can be used to contact emergency medical services (ems) services if an emergency occurs during the telemedicine visit or if the connection with the patient is lost. the clinician should then conduct the history as they would for an in-person visit. after the history has been obtained, a physical examination is performed. the depth of the physical exam depends on the location of the patient. if the patient is at a medical facility, the physical examination can be performed with the use of peripheral equipment (e.g. electronic stethoscope and otoscope) and the facilitator. if it is a dtc visit, a physical exam can still be performed, with the clinician guiding the patient to maneuver certain aspects for visualization. as expected, the telemedicine exam is not as comprehensive as compared to an in-person exam. however, it is not as limited as one might expect. with a little creativity, the clinician can still obtain a fair amount of useful data from the telemedicine exam. (see table iii for example telemedicine physical exam pearls). after the physical exam and medical decision making, an assessment and plan are formulated. it is necessary to write orders, give prescriptions, and provide instructions to the patient to conclude the visit. please see table iv for an overview of the steps for conducting a telemedicine visit. the utility of emr integration can depend upon the type of telemedicine that is employed. for remote monitoring telemedicine, there have been studies using patient-facing technologies to collect patient-generated health data that then flow into emrs (such as peak flow or frequency of mdi use). , however, these processes currently remain cumbersome and are not widely implemented. for video conferencing telemedicine visits, the medical history, orders, and visit notes associated with each video visit are integrated within the electronic health record (emr), thus improving work flows and clinician/patient satisfaction. , the patient-facing interface can be via the vendor's mobile application or emr patient portal. emr telemedicine vendors offer additional features including integration with referral management, scheduling and visit reminders, patient intake, and patient communications. please refer to the e-supplement for additional information on integration with emrs. in a recent meta-analysis, combined tele-case management and teleconsultation were effective telemedicine interventions to improve asthma control and quality of life in adults. telemedicine was also used to provide asthma education in medically underserved areas. scheduled facilitated telemedicine visits with certified asthma educators over a period of one year reduced the number of unscheduled visits for asthma. in addition, telemedicine was shown to be non- inferior to in-person evaluation for asthma care. this is particularly important in medically underserved areas where access to asthma specialists may not be readily available. remote presence solution (rps) equipped with a digital stethoscope, otoscope, and high-resolution camera was used to perform the visits in this study, with either a registered nurse or respiratory therapist serving as telefacilitator. a pilot study of patients published in utilizing telemedicine to evaluate penicillin allergy demonstrated high patient satisfaction and potential savings of over us$ , dollars due to increased access to specialty allergy/immunology care and improved antibiotic stewardship. as with any benefit comes an evaluation of risk. patient safety and the lack of inferiority of the quality of care with telemedicine versus standard care are ongoing areas of research. the relationship between telemedicine reimbursement rules and access to care is complex. concerns about potential overuse and quality of care have caused many payers to place considerable restrictions on fee-for-service telemedicine coverage. inconsistency among payers and states in coverage for telemedicine services may shift costs from payers to clinicians and patients, preventing adoption. the opportunity cost of non-reimbursed or under-reimbursed care has been a major barrier to telemedicine implementation and prior to covid- prevented many physicians and health systems from offering potentially valuable telemedicine services to their patients. studies show that when reimbursement is limited, patients are under-served by telemedicine services. coverage although parity in coverage (both in-person and telemedicine services are covered for the same indication) and payment (e.g., meaning that reimbursement for telemedicine services approximates that of the equivalent in-person e/m service) has never been universally mandated, payment parity is the coveted norm. existing data suggest that enactment of parity increases adoption of telemedicine. almost % of both users and non-users (of telemedicine) said they would use telemedicine if they were to be reimbursed. in fact, a . % increase in telemedicine adoption was noted after implementation of parity in michigan. because telemedicine coverage and reimbursement are not federally regulated, there is considerable variability in rules, depending on the state and insurer. no two payers or states are alike in how they define or cover telemedicine services. although the covid- phe has certainly brought increased coverage for telemedicine services, nationwide standardization of coverage and payment policies is still lacking. the center for medicare and medicaid services (cms) has historically placed strict limits on criteria for telemedicine reimbursement, requiring patients receiving telemedicine services to reside in a rural area and travel to a designated health center to receive facilitated care via a synchronous live video link. however, these strict limits on telemedicine services may have contributed to thwarting innovation and adoption of new technologies, thereby limiting access to care. even before the covid- pandemic, cms had pivoted to enhanced coverage of telemedicine. medicaid has generally had broader telemedicine coverage than medicare, but rules vary from state to state. currently, all states and washington dc provide reimbursement for some form of live video in medicaid fee-for-service plans. fourteen states reimburse for store and forward delivered services (not including teleradiology). twenty-two states reimburse for remote patient monitoring (rpm). insurer-specific policies. currently, states and washington dc have laws that govern private payer telemedicine reimbursement policies. some laws require reimbursement be equal to in- person coverage. however, most only require parity in covered services, not reimbursement amount. depending on how the law is written, it may provide payers with the ability to limit the amount of that coverage. unfortunately, inconsistent coverage and reimbursement policies among the various insurers can lead to confusion, incorrect coding and billing, and denied claims. some patients prefer to pay a convenience fee to access non-covered telemedicine services rather than come into the office for an in-person visit or forgo care. costs vary significantly but tend to be lower than the routine charges for an in-person evaluation. correct coding of telemedicine services is essential to obtaining reimbursement for care. in most cases, coding for telemedicine services was done using the corresponding codes for an in- person e/m visit (using either time or history and medical decision-making to justify the level), but with commercial insurers requiring the - modifier (synchronous telemedicine service rendered via a real-time interactive audio and video telecommunications system) appended. some insurers also accepted modifier gt in lieu of . medicare did not require a modifier for e/m services provided via telemedicine. place of service was to be designated as " " to signify telemedicine for all payers. while medicare only covered telemedicine services for established patients, some private payers permitted telemedicine visits for new patients, but not with the standard new patient cpt codes. instead, they required billing with code (unlisted evaluation and management code) with place of service " ". this may have been associated with lower reimbursement than an in-person new patient visit. due to this variability, it had always been best to check with each individual payer to determine how best to code telemedicine visits. for further information about cms coverage of telemedicine services pre- covid- , see table v . table vi for coding and billing telemedicine visits by time. for visits that are based on exam, documentation requirements for the systems that were examined is the same as for an in-person visit. please see table iii for telemedicine physical exam coding guidance. the covid- phe has rapidly ushered in expanded coverage/reimbursement for telemedicine services by both cms and commercial payers. one of the major changes from medicare includes the lifting of geographic restrictions on patient location, making telemedicine services available to medicare beneficiaries residing outside of underserved rural areas. beginning march , , medicare permitted patients to receive telemedicine services regardless of location and without the need to leave their homes to visit an originating site, such as a clinic that might be used for a fv. this means that, for the first time, medicare patients can receive telemedicine services from the comfort and safety of their own homes. cms issued guidance to use modifier - to designate an e/m service as telemedicine, and change the place of service for all care to the location in which the service would have ordinarily been provided instead of " ", thus enabling payments to achieve parity with in-person rates instead of being reimbursed at the lower facility rates. although cms itself is not waiving the cost-sharing for beneficiaries during the covid- phe, the office of the inspector general (oig) policy statement informed practitioners that they will not be sanctioned for choosing to reduce or waive a patient's cost- share obligations. during the covid- pandemic, medicare has continued to allow telemedicine visits to be billed either by e/m (with history, physical exam, and medical decision making, as per a normal in-person office visit) or by time (if billing based on time, % of the time must be spent on counseling and/or coordination of care, as per a normal in-person office visit). please see table iii for telemedicine physical exam coding guidance and table vi for coding and billing telemedicine visits by time. finally, medicare temporarily has permitted new patient codes to be billed for telemedicine visits and allowed telephone visits to be reimbursed at face-to-face rates, enabling virtual care for those patients without access to video technology. after weeks of rapidly changing guidance from commercial payers, many have now followed cms's lead, and adopted many of the same telemedicine coverage expansions. this has interestingly resulted in telemedicine billing/coding guidance that is significantly more uniform than pre-covid- . many commercial payers are now covering new patient visits via telemedicine. additionally, many have issued guidance to bill using the place of service " " instead of " ", along with modifier - or -gt. in many (but not all) cases, this will result in payments that achieve parity with in-person rates. see table vii for pre-and during-covid- changes based upon insurance. some states without coverage and payment parity laws have issued executive orders temporarily mandating coverage (and in some cases, payment) parity for telemedicine services provided for state residents. it remains to be seen if the increased adoption of telemedicine resulting from these changes will be maintained post-covid- or if coverage and parity policies return to baseline. see table viii for examples of telemedicine coding and billing. past data has shown that health care systems average a time period of months to implement digital healthcare solutions. with the mounting pressure to preserve clinical operations remotely during the covid- pandemic, many health care systems were faced with implementing telemedicine within a few weeks. systems that had already identified superusers and who had utilized telemedicine to address medical care access issues were quick to expand their telemedicine services. for any health care system, key factors of successful implementation include stakeholder engagement, end user buy-in, effective educational delivery programs and soliciting feedback. preparing clinicians for implementing telemedicine involves understanding of how telemedicine affects various aspects of the traditional clinic workflow, which will look different for a large health care system vs academic setting vs allergy/immunology private practice. (see table v) . in addition to these components of education, clinicians will require access to information regarding the most suitable telemedicine platform for their current needs. they expect to be able to access this information quickly as it rapidly changes during and after the post covid- pandemic. platforms will differ on the breadth of data security and privacy that is offered and will vary in their ability to be integrated within the emr available to the clinician for documentation and billing. federal regulators announced another set of regulatory changes and waivers, particularly relating to telemedicine, in response to the growing pandemic crisis throughout the united states. these changes are described in the e-supplement. with, specific technology requirements, and payer specific requirements as well. this process has been accelerated with the covid- pandemic, and many regulatory and payer issues have been waived or modified to allow a rapid response to changing practice logistics, such as eliminating licensing requirements for out of state telemedicine visits until the covid- pandemic emergency has diminished. upon the rescinding of federal and state emergency orders related to covid- , these requirements may revert back to their prior complexity or continue to exist in a partially modified form. it is therefore advisable that all of these bodies be consulted prior to beginning/continuing the practice of telemedicine in order to ensure proper care, fair reimbursement, avoidance of unforeseen medicolegal issues, and to provide the best care for our patients. it is also advisable that clinicians regularly check laws, legislative agendas, best practice recommendations, and payer policies to ensure the practice continues to be compliant. this section will provide information for approaching this process and cover regulatory issues at the state level, but not reimbursement or technology requirements. efforts are being made by the interstate medical licensure compact commission, (a branch of the federation of state medical boards that joins states, the district of columbia and the territory of guam), to continue expansion to other states as they assist physicians with their telemedicine licensing needs.this is an excellent resource for ongoing formation regarding licensure. upon expiration of current emergency orders removing barriers to telemedicine licensure and requirements, the lack of license portability will continue to be a barrier. there is an expedited process for licensing board-certified physicians with no background issues. but physicians practicing in multiple states must adhere to a variety of state-specific medical practice regulations, and there are annual license renewal fees for each state license. there is no national licensure at present. the exception to this is patients and clinicians working with the veterans administration (va) system, where rules were in place effectively bypassing state licensure laws. please see the specific licensing issues in the e-supplement. it is important to maintain health insurance portability and accountability act of (hipaa) compliance in a telemedicine visit in the same manner as an in-person clinic visit. medical professionals often mistakenly believe that communicating electronic protected health information (ephi) is acceptable when the communication is directly between physician and patient. often, little regard is given to the method of communication that is used for communicating ephi. medical professionals who wish to comply with the hipaa guidelines on telemedicine must adhere to rigorous standards for such communications to be deemed compliant. hipaa requires ephi data be encrypted when they are transferred. hipaa also directs that a telemedicine vendor must monitor data that are stored during transfer. skype do not have a baa and thus previously did not fully comply with hipaa. some small practices use these platforms for telemedicine. however, some insurers will not pay for telemedicine care that uses the non-baa platforms, and some large organizations will not allow their doctors to use these platforms. in addition, copies of communications sent by sms, skype, or email remain on the service clinicians´ servers and contain individually identifiable healthcare information that is not encrypted. this ephi is also not considered hipaa compliant. there are a variety of vendors that provide telemedicine technology (table ia) . because each technology changes frequently, it is important to visit each vendor's website for information about current offerings. it is important to check with each company to determine hipaa compliance and encryption and to verify it with an it security expert. other technologies to consider utilizing include intrusion detection systems (ids), web application protection, and log management. patients have every right to be concerned about privacy and question how their information will be handled during a telemedicine visit. clinicians should be prepared to educate patients about the steps taken for hipaa compliance and ways to ensure the privacy of other confidential information. it is important to let patients know technology is designed for this purpose and that clinicians take this obligation under hipaa very seriously. the emergency declaration by the president of the united states on march , removed some of the hipaa and state-related barriers that required recording all telemedicine visits and that those copies be maintained in an archive as part of the medical record. for the time being, cms has also noted that accidental hipaa violations that occur in the course of caring for patients via this method will not be prosecuted, as long as the clinician was acting in the best interest of the patient. many state governors have released similar letters providing similar policies for medicaid in their respective states. with the declaration, the originating site can be the patient's home, nursing homes, hospital outpatient departments, and other settings and across state lines. to immediately allow clinicians to start telemedicine services, hhs office for civil rights (ocr) will exercise enforcement discretion and waive penalties for hipaa violations against healthcare clinicians who serve patients in good faith through everyday communications technologies such zoom (zoom video communications, inc., san jose, ca), skype, and facetime, among others. telemedicine visits are also more flexible in that the video solution has an exception for hipaa security rules requiring baa for technology. this change now also supports platforms such as facetime, google hangouts, and skype which do not offer a baa. nevertheless, best practice is to work toward the use of a hipaa-compliant video solution as soon as available. this emergency declaration regarding telemedicine requirements is to extend through the covid- phe. at this point it remains unclear how long these changes will remain in effect or what form they will take once the covid- emergency ends. to dispel any confusion, clinicians need to remember that hipaa regulations are still in place at this time; it is the enforcement of these regulations that has been temporarily relaxed. telemedicine has been shown to increase access to and decrease the cost of medical care. , , , , many of the types of patients that we care for in the field of allergy and immunology can be helped using telemedicine. past examples include the use of telemedicine for asthma and antibiotic allergy and stewardship. [ ] [ ] [ ] [ ] we and our patients are therefore uniquely positioned to take advantage of and benefit from telemedicine. until recently, however, there was not widespread adoption of telemedicine. therefore, a work group from the health, information, technology and education (hite) committee of the american academy of allergy, asthma, and immunology was formed to investigate the baseline use and needs of the allergy and immunology community with regards to telemedicine. since that time, the covid- pandemic has led to an unprecedented heightened need for telemedicine from private practices to academic centers throughout the country. , , there is now an opportunity to integrate telemedicine into the medical education curriculum and experience telemedicine at all levels. it remains to be seen if the changes in technology, regulation and reimbursement of telemedicine will be maintained long term. hite is planning to longitudinally follow the adoption of telemedicine by allergy/immunology clinicians in the context of covid- and afterwards. our goal is to continue the development of tools to assist allergy/immunology clinicians with adoption of telemedicine and to help push the boundaries of telemedicine use by the allergy and immunology community. covid- : pandemic contingency planning for the allergy and immunology clinic keep calm and log on: telemedicine for covid- pandemic response virtually perfect? telemedicine for covid- department of health & human services. health information privacy tips for seeing patients via telemedicine based outpatient telemedicine program on time savings, travel costs, and environmental pollutants. value in health utilization of interactive clinical video telemedicine by rural and urban veterans in the veterans health administration health care system american telemedicine association. examples of research outcomes: telemedicine's impact on adding telemedicine to icus in va hospitals reduced transfers of sickest patients prevalence, predictors and economic consequences of no-shows telemedicine in the era of covid- a cost savings analysis of asynchronous teledermatology compared to face-to-face dermatology in catalonia cost- benefit analysis of telehealth in pre-hospital care centers for disease control and prevention, department of health and human services office of inspector general. hospital experiences responding to the covid- pandemic: results of a national pulse survey medicare-telemedicine-health-care-provider-fact-sheet. . the center for connected health policy. national policy: informed consent effectiveness of population health management using the propeller health asthma platform: a randomized clinical trial an internet-based store-and-forward video home telehealth system for improving asthma outcomes in children telemedicine integrated with clinical care: patient experiences telemedicine integrated with clinical care the effects of telemedicine on asthma control and patients' quality of life in adults: a systematic review and meta-analysis the uses of telemedicine to improve asthma control telemedicine is as effective as in-person visits for patients with asthma the use of telemedicine for penicillin allergy skin testing patient safety risks associated with telecare: a systematic review and narrative synthesis of the literature lack of reimbursement barrier to telehealth adoption state policies influence medicare telemedicine utilization. telemed j e health the center for connected health policy. state telehealth laws & reimbursement policies: a comprehensive scan of the fifty states and the district of columbia patient and clinician experiences with telehealth for patient follow-up care regarding physicians and other practitioners that reduce or waive amounts owed by federal health care program beneficiaries for telehealth services during the novel coronavirus the center for connected health policy. covid- related state actions ama quick guide to telemedicine in practice the future of telehealth in allergy and immunology training what physicians need to know about cyber insurance digital platforms heighten cyber exposures coronavirus aid, relief, and economic security act veterans affairs department. authority of health care providers to practice telehealth the department of health and human services, national telecommunications and information administration american college of allergy . the center for connected health policy. national policy: hipaa how to start doing telemedicine now (in the covid- crisis telemedicine technology: a review of services, equipment, and other aspects synchronous telehealth for outpatient allergy consultations: a -year regional experience virtual health care in the era of covid- telehealth implementation playbook american telemedicine association. telemedicine forms utilize telemedicine: how does billing work? medicare telemedicine health care provider fact sheet hcpcs g ). (hcpcs g ) medicare shared savings program requirements; quality payment program; medicaid promoting interoperability program; quality payment program-extreme and uncontrollable circumstance policy for the mips payment year; provisions from the medicare shared savings program-accountable care organizations-pathways to success; and expanding the use of telehealth services for the treatment of opioid use disorder under the substance use-disorder prevention that promotes opioid recovery and treatment (support) for patients and communities act yes, if covid-related (yes, through / / )* % yes yes date range for covid- phe telehealth expansion (subject to modification) key: cord- - djnf authors: huynen, maud mte; martens, pim; hilderink, henk bm title: the health impacts of globalisation: a conceptual framework date: - - journal: global health doi: . / - - - sha: doc_id: cord_uid: djnf this paper describes a conceptual framework for the health implications of globalisation. the framework is developed by first identifying the main determinants of population health and the main features of the globalisation process. the resulting conceptual model explicitly visualises that globalisation affects the institutional, economic, social-cultural and ecological determinants of population health, and that the globalisation process mainly operates at the contextual level, while influencing health through its more distal and proximal determinants. the developed framework provides valuable insights in how to organise the complexity involved in studying the health effects resulting from globalisation. it could, therefore, give a meaningful contribution to further empirical research by serving as a 'think-model' and provides a basis for the development of future scenarios on health. good health for all populations has become an accepted international goal and we can state that there have been broad gains in life expectancy over the past century. but health inequalities between rich and poor persist, while the prospects for future health depend increasingly on the relative new processes of globalisation. in the past globalisation has often been seen as a more or less economic process. nowadays it is increasingly perceived as a more comprehensive phenomenon, which is shaped by a multitude of factors and events that are reshaping our society rapidly. this paper describes a conceptual framework for the effects of globalisation on population health. the framework has two functions: serving as 'think-model', and providing a basis for the development of future scenarios on health. two recent and comprehensive frameworks concerning globalisation and health are the ones developed by woodward et al. [ ] , and by labonte and togerson [ ] . the effects that are identified by woodward et al. [ ] as most critical for health are mainly mediated by economic factors. labonte and torgerson [ ] primarily focus on the effects of economic globalisation and international governance. in our view, however, the pathways from globalisation to health are more complex. therefore, a conceptual framework for the health effects of the globalisation process requires a more holistic approach and should be rooted in a broad conception of both population health and globalisation. the presented framework is developed in the following three steps: ) defining the concept of population health and identifying its main determinants, ) defining the concept of globalisation and identifying its main features and ) constructing the conceptual model for globalisation and population health. as the world around us is becoming progressively interconnected and complex, human health is increasingly perceived as the integrated outcome of its ecological, social-cultural, economic and institutional determinants. therefore, it can be seen as an important high-level integrating index that reflects the state-and, in the long term, the sustainability-of our natural and socio-economic environments [ ] . this paper primarily focuses on the physical aspects of population health like mortality and physical morbidity. our identification of the most important factors influencing health is primarily based on a comprehensive analysis of a diverse selection of existing health models (see huynen et al [ ] for more details). we argue that the nature of the determinants and their level of causality can be combined into a basic framework that conceptualises the complex multi-causality of population health. in order to differentiate between health determinants of different nature, we will make the traditional distinction between social-cultural, economic, environmental and institutional factors. these factors operate at different hierarchical levels of causality, because they have different positions in the causal chain. the chain of events leading to a certain health outcome includes both proximal and distal causes; proximal factors act directly to cause disease or health gains, and distal determinants are further back in the causal chain and act via (a number of) intermediary causes [ ] . in addition, we also distinguish contextual determinants. these can be seen as the macro-level conditions shaping the distal and proximal health determinants; they form the context in which the distal and proximal factors operate and develop. subsequently, a further analysis of the selected health models and an intensive literature study resulted in a wide-ranging overview of the health determinants that can be fitted within this framework ( figure and table ). we must keep in mind, however, that determinants within and between different domains and levels interact along complex and dynamic pathways to 'produce' health at the population level. additionally, health in itself can also influence its multi-level, multi-nature determinants; for example, ill health can have a negative impact on economic development. there is more and more agreement on the fact that globalisation is an extremely complex phenomenon; it is the interactive co-evolution of multiple technological, cultural, economic, institutional, social and environmental trends at all conceivable spatiotemporal scales. hence, rennen and martens [ ] define contemporary globalisation as an intensification of cross-national cultural, economic, political, social and technological interactions that lead to the establishment of transnational structures and the global integration of cultural, economic, environmental, political and social processes on global, supranational, national, regional and local levels. although somewhat complex, this definition is in line with the view on globalisation in terms of deterritorialisation and explicitly acknowledges the multiple dimensions involved. however, the identification of all possible health effects of the globalisation process goes far beyond the current capacity of our mental ability to capture the dynamics of our global system; due to our ignorance and interdeterminacy of the global system that may be out of reach forever [ ] . in order to focus our conceptual framework, we distinguish-with the broader definition of globalisation in mind-the following important features of the globalisation process: (the need for) new global governance structures, global markets, global communication and diffusion of information, global mobility, cross-cultural interaction, and global environmental changes (table ) (see huynen et al. [ ] for more details). we have identified (the need for) global governance structures, global markets, global communication and the diffusion of information, global mobility, cross-cultural interaction, and global environmental changes as important features of globalisation. based on figure and table , it can be concluded that these features all operate at the contextual level of health determination and influence distal factors such as health(-related) policies, economic development, trade, social interactions, knowledge, and the provision of ecosystem goods and services. in turn, these changes in distal factors have the potential to affect the proximal health determinants and, consequently, health. our conceptual framework for globalisation and health links the above-mentioned features of the globalisation process with the identified health determinants. this exercise results in figure . figure , subsequently, shows that within the developed framework, several links between the specific features of globalisation and health can be derived. these important links between globalisation and health are discussed in the following sections. it is important to note that figure primarily focuses on the relationships in the direction from globalisation to health. this does not mean, however, that globalisation is an autonomous process: globalisation is influenced by many developments at the other levels, although these associations are not included in the figure for reasons of simplification. in addition, the only feedback that is included in figure concerns the institutional response. one also has to keep in mind that determinants within the distal level and within the proximal level also interact with each other, adding complexity to our model (see huynen [ ] [ ] [ ] [ ] . below, the implications of the globalisation process on these distal determinants will be discussed in more detail. global governance structures are gaining more and more importance in formulating health(-related) policies (figure ; arrow ). according to dodgson et al. [ ] , the most important organisations in global health governance are the world health organization (who) and the world bank (wb). the latter plays an important role in the field of global health governance as it acknowledges the importance of good health for economic development and focuses on reaching the millennium development goals [ ] . the wb also influenced health(-related) policies together with the international monetary funds (imf) through the structural adjustment programmes (saps) (e.g. see hong [ ] ). in order to give a more central role to pro-poor growth considerations in providing assistance to low-income countries, the imf and wb introduced the poverty reduction strategy approach in [ ] . in addition, the policies of the world trade organization (wto) are also increasingly influencing population health [ , [ ] [ ] [ ] . fidler [ ] argues that 'from the international legal perspective, the centre of power for global health governance has shifted from who to the wto'. opinions differ with regard to whether the wto agreements provide sufficient possibilities to protect the population from the adverse (health) effects of free trade or not multi-nature and multi-level framework for population health figure multi-nature and multi-level framework for population health. new global governance structure globalisation influences the interdependence among nations as well as the nation state's sovereignty leading to (a need for) new global governance structures. global markets globalisation is characterised by worldwide changes in economic infrastructures and the emergence of global markets and a global trading system. globalisation makes the sharing of information and the exchange of experiences around common problems possible. global mobility global mobility is characterised by a major increase in the extensity, intensity and velocity of movement and by a wide variety in 'types' of mobility. globalising cultural flows result in interactions between global and local cultural elements. global environmental threats to ecosystems include global climate change, loss of biodiversity, global ozone depletion and the global decline in natural areas. conceptual framework for globalisation and population health another important development is the growing number of public-private partnerships for health, as governments increasingly attract private sector companies to undertake tasks that were formerly the responsibility of the public sector. at the global level, public-private partnerships are more and more perceived as a possible new form of global governance [ ] and could have important implications for health polices, but also for health-related policies. opinions differ with regard to the economic benefits of economic globalisation (figure ; arrow ). on the one side, 'optimists' argue that global markets facilitate economic growth and economic security, which would benefit health. they base themselves on the results of several studies that argue that inequities between and within countries have decreased due to globalisation (e.g. see frankel [ ] , ben david [ ] , dollar and kraay [ ] ). additionally, it is argued that although other nations or households might become richer, absolute poverty is reduced and that this is beneficial for the health of the poor [ ] . on the other side, 'pessimists' are worried about the health effects of the exclusion of nations and persons from the global market. they argue that the risk of exclusion from the growth dynamics of economic globalisation is significant in the developing world [ ] . in fact, notwithstanding some spectacular growth rates in the 's, especially in east asia, incomes per capita declined in almost countries during the same period [ ] . many worry about what will happen to the countries that cannot participate in the global market as successful as others. due to the establishment of global markets and a global trading system, there has been a continuing increase in world trade (figure ; arrow ). according to the wto, total trade multiplied by a factor between and [ ] . today all countries trade internationally and they trade significant proportions of their national income; around percent of world output is being traded. the array of products being traded is wide-ranging; from primary commodities to manufactured goods. besides goods, services are increasingly being traded as well [ ] . in addition to legal trade transactions, illegal drug trade is also globalising, as it circumvents national and international authority and takes advantage of the global finance systems, new information technologies and transportation. due to the changes in the infrastructures of transportation and communication, human migration has increased at unprecedented rates ( figure ; arrow ) [ ] . according to held et al. [ ] tourism is one of the most obvious forms of cultural globalisation and it illustrates the increasing time-space compression of current societies. however, travel for business and pleasure constitutes only a fraction of total human movement. other examples of people migrating are missionaries, merchant marines, students, pilgrims, militaries, migrant workers and peace corps workers [ , ] . besides these forms of voluntary migration, resettlement by refugees is also an important issue. however, since the late s, the concerns regarding the economic, political, social and environmental consequences of migration has been growing and many governments are moving towards more restrictive immigration policies [ ] . the tragic terrorist attacks in new york and washington d.c. in september fuelled the already ongoing discussions on the link between globalisation and conflicts. globalisation can decrease the risk on tensions and conflicts, as societies become more and more dependent on each other due the worldwide increase in global communication, global mobility and cross-cultural interactions ( figure ; arrow ). others argue that the resistance to globalisation has resulted in religious fundamentalism and to worldwide tensions and intolerance [ ] . in addition, the intralevel relationships at the distal level play a very important role, because many developments in other distal factors that have been associated with the globalisation process are also believed to increase the risk on conflicts. in other words, the globalisation-induced risk on conflict is often mediated by changes in other factors at the distal level [ ] . cultural globalisation (global communication, global mobility, cross-cultural interaction) can also influence cultural norms and values about social solidarity and social equity (figure ; arrow ) . it is feared that the selfinterested individualism of the marketplace spills over into cultural norms and values resulting in increasing social exclusion and social inequity. exclusion involves disintegration from common cultural processes, lack of participation in social activities, alienation from decisionmaking and civic participation and barriers to employment and material sources [ ] . alternatively, a socially integrated individual has many social connections, in the form of both intimate social contacts as well as more distal connections [ ] . on the other hand, however, the geographical scale of social networks is increasing due to global communications and global media. the women's movement, the peace movement, organized religion and the environmental movement are good examples of such transnational social networks. besides these more formal networks, informal social networks are also gaining importance, as like-minded people are now able to interact at distance through, for example, the internet. in addition, the global diffusion of radio and television plays an important role in establishing such global networks [ ] . the digital divide between poor and rich, however, can result in social exclusion from the global civil society. the knowledge capital within a population is increasingly affected by developments in global communication and global mobility (figure : arrow ). the term 'globalisation of education' suggests getting education into every nook and cranny of the globe. millions of people now acquire part of their knowledge from transworld textbooks, due to the supraterritoriality in publishing. because of new technologies, most colleges and universities are able to work together with academics from different countries, students have ample opportunities to study abroad and 'virtual campuses' have been developed. the diffusion of new technologies has enabled researchers to gather and process data in no time resulting in increased amounts of empirical data [ ] . new technologies have even broadened the character of literacy. scholte [ ] argues that 'in many line of work the ability to use computer applications has become as important as the ability to read and write with pen and paper. in addition, television, film and computer graphics have greatly enlarged the visual dimensions of communication. many people today 'read' the globalised world without a book'. overall, it is expected that the above-discussed developments will also improve health training and health education (e.g. see feachem [ ] and lee [ ] ). global environmental changes can have profound effects on the provision of ecosystem goods and services to mankind ( figure ; arrow ) . the intergovernmental panel on climate change (ipcc) [ ] concludes that it is expected that climate change can result in significant ecosystem disruptions and threatens substantial damage to the earth's natural systems. in addition, several authors have addressed the link between biodiversity and ecosystem functioning and it is agued that maintaining a certain level of biodiversity is necessary for the proper provision of ecosystem goods and services [ ] [ ] [ ] [ ] . however, it is still unclear which ecosystem functions are primarily important to sustain our physical health. basically, the following types of 'health functions' can be distinguished. first, ecosystems provide us with basic human needs like food, clean air, clean water and clean soils. second, they prevent the spread of diseases through biological control. finally, ecosystems provide us with medical and genetic resources, which are necessary to prevent or cure diseases [ ] . figure shows that the impact of globalisation on each proximal health determinant is mediated by changes in several distal factors (figure ; arrows - ). the most important relationships will be discussed in more detail below. it is important to note that health policies and health-related policies can have an influence on all proximal factors (figure ; arrow ). health services are increasingly influenced by globalisation-induced changes in health care policy (figure ; arrow ), economic development and trade ( figure : arrow ), and knowledge ( figure ; arrow ), but also by migration ( : arrow ). although the who aims to assist governments to strengthen health services, government involvement in health care policies has been decreasing and, subsequently, medical institutions are more and more confronted with the neoliberal economic model. health is increasingly perceived as a private good leaving the law of the market to determine whose health is profitable for investment and whose health is not [ ] . according to collins [ ] populations of transitional economies are no longer protected by a centralized health sector that provides universal access to everyone and some groups are even denied the most basic medical services. the u.s. and several latin american countries have witnessed a decline in the accessibility of health care following the privatisation of health services [ ] . the increasing trade in health services can have profound implications for provision of proper health care. although it is perceived as to improve the consumer's choice, some developments are believed to have long-term dangers, such as establishing a two-tier health system, movement of health professionals from the public sector to the private sector, inequitable access to health care and the undermining of national health systems [ , ] . the illegal trading of drugs and the provision of access to controlled drugs via the internet are potential health risks [ ] . in addition, the globalisation process can also result in a 'brain-drain' in the health sector as a result of labour migration from developing to developed regions. however, increased economic growth is generally believed to enhance improvements in health care. increased (technological) knowledge resulting from the diffusion of information can further improve the treatment and prevention of all kinds of illnesses and diseases. the central mechanism that links personal affiliations to health is 'social support,' the transfer from one person to another of instrumental, emotional and informational assistance [ ] . social networks and social integration are closely related to social support [ ] and, as a result, globalisation-induced changes in social cohesion, integration and interaction can influence the degree of social support in a population (figure ; arrow ). this link is, for example, demonstrated by reeves [ ] , who discussed that social interactions through the internet influenced the coping ability of hiv-positive individuals through promoting empowerment, augmenting social support and facilitating helping others. alternatively, social exclusion is negatively associated with social support. another important factor in the social environment is violence, which often is the result of the complex interplay of many factors (figure ; arrows , and ). the who [ ] argues that globalisation gives rise to obstacles as well as benefits for violence prevention. it induces changes in protective factors like social cohesion and solidarity, knowledge and education levels, and global violence prevention activities such as the implementation of international law and treaties designed to reduce violence (e.g. social protection). on the other hand, it also influences important risk factors associated with violence such as social exclusion, income inequality, collective conflict, and trade in alcohol, drugs or firearms. due to the widespread flow of people, information and ideas, lifestyles also spread throughout the world. it is already widely acknowledged and demonstrated that several modern behavioural factors such as an unhealthy diet, physical inactivity, smoking, alcohol misuse and the use of illicit drugs are having a profound impact on human health [ ] [ ] [ ] [ ] (table ) . individuals respond to the range of healthy as well as unhealthy lifestyle options and choices available in a community [ ] , which are in turn determined by global trade (figure ; arrow ), economic development (figure ; arrow ) and social interactions ( figure ; arrow ). although the major chronic diseases are not transmittable via an infectious agent, the behaviours that predispose to these diseases can be communicated by advertising, product marketing and social interactions [ ] . global trade and marketing developments drive, for example, the nutrition transition towards diets with high proportions of salt, saturated fat and sugars [ , ] . another example is the worldwide spread of tobacco consumption as transnational tobacco companies take advantage of the potential for growth in developing countries [ , ] . additionally, the scale of cigarette smuggling poses a considerable global threat to the efforts to control tobacco consumption [ ] . illegal trade in illicit drugs poses similar problems. at the same time, the alcohol industry is almost as globalised as the tobacco industry [ ] . however, health education can play a role in promoting healthy lifestyles by improving an individual's knowledge about the health effects of different lifestyle options (figure ; arrow ). besides health education, (global) policies can also directly discourage unhealthy behaviour by means of economic incentives (e.g. charging excise on tobacco) or other legislation (figure ; arrow ). the spread of infectious diseases is probably one of the most mentioned health effects of globalisation and past disease outbreaks have been linked to factors that are related to the globalisation process (see e.g. newcomb [ ] ). the recent outbreak of the severe acute respiratory syndrome (sars) demonstrates the potential of new infectious diseases to spread rapidly in today's world, increasing the risk of a global pandemic. the combination of movement of goods ( figure ; arrow ) and people ( figure ; arrow ), and profound changes affecting ecosystem goods and services (figure ; arrow ) all contribute to increased risk of disease spread [ ] . for example, the globalisation of food production, trade and consumption has been associated with the increased spread and transmission of food born diseases [ , ] . diseases like hiv/aids or hepatitis b can also spread through trade in infected biological products (e.g. blood) [ ] . enhanced knowledge and new technologies will improve the surveillance of infectious diseases and monitoring of antibiotic resistance [ , ] (figure ; arrow ). globalisation potentially increases the speed of responses in some cases. wilson [ ] states that responding to disease emergence requires a global perspective-both conceptually and geographically-as the current global situation favours the outbreak and rapid spread of infectious disease. as a result, the policies and actions undertaking by the who are becoming increasingly important in controlling infectious diseases at a global level (figure ; arrow ). for instance, the who played a critical role in controlling sars by means of global alerts, geographically specific travel advisories and monitoring [ ] . food trade has become an increasingly important factor with regard to food security worldwide (figure ; arrow ). at present, however, the developed countries usually subsidise their agricultural sectors. current liberalisation policies are expected to have profound implications on food trade and, subsequently food security [ ] . some argue that the resulting free trade will create access to better and cheaper food supplies via food imports and can excess energy intake results, together with physical activity, in obesity. obesity is an increasing health problem and has several co-morbidities such as non-insulin dependent diabetes and cardiovascular diseases [ ] . the nutritional quality of the diet (e.g. fruit and vegetable intake, saturated versus unsaturated fats) is also very important for good health. inactivity physical inactivity has been linked to obesity, coronary hearth disease, hypertension, strokes, diabetes, colon cancer, breast cancer and osteoporotic fractures [ ] . tobacco is predicted to be the leading health risk factor by [ ] . it causes, for example, cancer of the trachea, bronchus and lung [ ] , and cardiovascular diseases. alcohol use the consumption of alcoholic beverages increases to risk on liver cirrhosis, raised blood pressure, heart disease, stroke, pancreatitis and cancers of the oropharnix, larynx, oesophagus, stomach, liver and rectum [ ] . the role of alcohol consumption in non-communicable disease epidemiology is, however, complex. for example, small amounts of alcohol reduce the risk on cardiovascular diseases, while drinking larger amounts is an important cause of these very same diseases [ ] . according to the world health report [ ] , , % of the total disease burden is attributable to illicit drugs (heroin and cocaine). opiate users can have overall mortality rate up to percent higher than those in the general population of the same age, due to not only overdoses but also to accidents, suicides, aids and other infectious diseases [ ] . stimulate more efficient use of the world's resources as well as the production of food in regions that are more suitable to do so [ , ] . free trade permits food consumption to grow faster than domestic food production in countries where there are constraints on increasing the latter. accelerated economic growth can also contribute to food security (figure ; arrow ) [ ] . others, however, argue that the forces of globalisation in fact endanger food security (e.g. see lang [ ] ) and that countries should strive to become more self-sufficient [ ] . for many countries the increasing dependence on food imports goes hand in hand with a higher vulnerability to shocks arising in global markets, which can affect import capacity and access to food imports [ ] . many food insecure countries are not able to earn enough with exporting goods in order to pay for the needed food imports [ ] . at the global level, there are increasing international efforts to achieve widespread food security ( figure ; arrow ). for instance, the right to adequate food is directly addressed in the international covenant on economic, social and cultural rights. in , the world food summit reaffirmed the right of everyone to have access to safe and nutritious food. in case of extreme foodinsecurity and insufficient import capacity, food aid may be provided in order to supplement the scarce food imports. globalisation can affect food security by enhancing the knowledge of foreign nations about the usefulness of food aid (figure ; arrow ) [ ] . besides food trade, one can also deal with the mismatch between demand and supply by increasing food production in food-short regions. the globalisation process can increase food security by facilitating the worldwide implementation of better technologies and improved knowledge (e.g. irrigation technologies, research on genetically modified food) ( figure ; arrow ). at the same time, the natural resource base for food production is increasingly threatened (figure ; arrow ). finally conflicts are, of course, a threat to food security and it is expected that food security in sub-saharan africa, for example, will not increase without the establishment of political instability (figure ; arrow ) [ ] . the effects of globalisation are also raising concerns over water security. the current globalisation process is accompanied by privatisation policies affecting the provision of water [ ] (figure ; arrow ). governments and international financial institutions promote privatisation, as they believe it will promote market competition and efficiency. however, others are less optimistic about the effects of privatisation. in fact, some cases show that prices and inequalities in access even rise [ ] . it is also argued that water, with vital importance socially, culturally, and ecologically, 'cannot be protected by purely market forces' [ ] . on a global scale, there are increasing efforts to set up global guidelines or policies with regard to fresh water ( figure ; arrow ), however none of the international declarations and conference statements requires states to actual meet individual's water requirements [ ] . the virtual trade of water is also believed to be of increasing importance (figure ; arrow ). the water that is used in the production process of a commodity is called the 'virtual water' contained in that commodity. therefore, the increasing global trade of commodities is accompanied by an increasing global trade in virtual water. the global volume of virtual water embedded in crop and livestock products traded between nations is estimated to be billion cubic metres per year [ ] . in addition, the globalisation process can increase water security by facilitating the worldwide implementation of better technologies and improved knowledge ( figure ; arrow ). at the same time, the natural resource base is increasingly threatened as, for example, global climate change and deforestation profoundly affect our ecosystems ability to provide us with sufficient and adequate fresh water (figure ; arrow ). globalisation is causing profound and complex changes in the very nature of our society, bringing new opportunities as well as risks. in addition, the effects of globalisation are causing a growing concern for our health, and the intergenerational equity implied by 'sustainable development' forces us to think about the right of future generations to a healthy environment and a healthy life. despite some empirical research efforts indicating the links between the globalisation process and specific health impacts, the present weakness in empirical evidence on the multiple links between globalisation and health is still a problem [ ] . the described conceptual framework could give a meaningful contribution to further empirical research by serving as a well-structured 'think-model' or 'concept map'. it clearly demonstrates that an interdisciplinary approach towards globalisation and health is required, which draws upon the knowledge from relevant fields such as, for example, medicine, epidemiology, sociology, political sciences, (health) education, environmental sciences and economics. in addition, the exploration of possible future health impacts of different globalisation pathways by means of scenarios analysis could provide a useful contribution to the ongoing discussions on globalisation and health [ ] . scenarios can be described as 'plausible but simplified descriptions of how the future may develop, according to a coherent and internally consistent set of assumptions about key driving forces and relationships' [ ] . recent research showed, however, that the health dimension is largely missing in existing global scenarios [ ] . the developed framework for globalisation and population health has contributed to the understanding of future health implications and the model is, therefore, considered to be a useful tool to structure future scenario studies on the health implications of the globalisation process. to conclude, the framework provides valuable insights in how to organise the complexity involved in studying the health effects resulting from globalisation. we claim that our approach has several beneficial characteristics. first, it is embedded in a holistic approach towards globalisation; in this paper we perceive globalisation as an overarching process in which simultaneously many different processes take place in many societal domains. in addition, the conceptual framework is embedded in a holistic approach towards population health. as a result, our model explicitly visualises that globalisation affects the institutional, economic, social-cultural and ecological determinants of population health and that the globalisation process mainly operates at the contextual level, while influencing health through the more distal and proximal determinants. globalization and health: a framework for analysis and action 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vancouver, university of british colombia global health governance: overview of the role of international law in protecting and promoting global public health. london, centre on global change and health, london school of hygiene and tropical medicine wto: european communities measures affecting asbestos and asbestos-containing products wto: european communities measures concerning meat and meat products (hormones). wt/ds /r/usa and wt/ ds /r/can. panel report wto: european communities measures concerning meat and meat products (hormones) does trade cause growth? american economic review d: trade, growth and disparity among nation growth is good for the poor globalisation is good for your health, mostly the policy challenges of globalisation and regionalisation global public policy: governing without government? wto: the world trade organization in brief global transformations: politics, economics and culture travel and the emergence of infectious diseases united nations, department of 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social relations and health from social integration to health: durkheim in the new millennium coping in cyberspace: the impact of internet use on the ability of hiv-positive individuals to deal with their illness who: the european health report . copenhagen, world health organization, regional office for europe who: the world health report . geneva, world health organization globalisation and the prevention and control of non-communicable diseases: the neglected chronic diseases of adults who: the world health report diseases of globalisation chronic disease smoke and mirrors: the canadian tobacco war. canada, international development research centre thirsting for markets: the global impact of corporate alcohol. marin county, marin institute for the prevention of alcohol and other drug problems biology and borders: sars and the new economics of bio-security lee k: globalization, communicable disease and equity fidler d: germs, governance, and global public health in the wake of sars fao: food and international trade. rome, food and agricultural organisation of the united nations fao: the state of food insecurity in the world . rome, food and agricultural organisation of the united nations food security: does it conflict with globalisation? development fao: trade reforms and food security: conceptualizing the linkages. rome, food and agricultural organisation of the united nations united states department of agriculture the world's water - : the biennial report on freshwater resources cochabamba! water war in bolivia. cambridge the world's water - : the biennial report on freshwater resources presented at aqua: european citizenship through water the problem of the future: sustainability science and scenario analysis a future without health: health dimension in global scenario studies we would like to thank all colleagues at the international centre for integrative studies (icis) and the netherlands environmental assessment agency (mnp-rivm) for the fruitful discussions leading to this paper. this work is financially supported by mnp-rivm within the project 'population & health'. the author(s) declare that they have no competing interests.publish with bio med central and every scientist can read your work free of charge key: cord- -z l tsir authors: johnson, sonia; dalton-locke, christian; vera san juan, norha; foye, una; oram, sian; papamichail, alexandra; landau, sabine; rowan olive, rachel; jeynes, tamar; shah, prisha; sheridan rains, luke; lloyd-evans, brynmor; carr, sarah; killaspy, helen; gillard, steve; simpson, alan title: impact on mental health care and on mental health service users of the covid- pandemic: a mixed methods survey of uk mental health care staff date: - - journal: soc psychiatry psychiatr epidemiol doi: . /s - - - sha: doc_id: cord_uid: z l tsir purpose: the covid- pandemic has potential to disrupt and burden the mental health care system, and to magnify inequalities experienced by mental health service users. methods: we investigated staff reports regarding the impact of the covid- pandemic in its early weeks on mental health care and mental health service users in the uk using a mixed methods online survey. recruitment channels included professional associations and networks, charities, and social media. quantitative findings were reported with descriptive statistics, and content analysis conducted for qualitative data. results: , staff from a range of sectors, professions, and specialties participated. immediate infection control concerns were highly salient for inpatient staff, new ways of working for community staff. multiple rapid adaptations and innovations in response to the crisis were described, especially remote working. this was cautiously welcomed but found successful in only some clinical situations. staff had specific concerns about many groups of service users, including people whose conditions are exacerbated by pandemic anxieties and social disruptions; people experiencing loneliness, domestic abuse and family conflict; those unable to understand and follow social distancing requirements; and those who cannot engage with remote care. conclusion: this overview of staff concerns and experiences in the early covid- pandemic suggests directions for further research and service development: we suggest that how to combine infection control and a therapeutic environment in hospital, and how to achieve effective and targeted tele-health implementation in the community, should be priorities. the limitations of our convenience sample must be noted. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. been launched, there has been less focus on the needs of people already living with mental health conditions, and on how mental health services are supporting them at a time of potential staff shortages and service reconfigurations [ ] . potential risks to provision of mental health care worldwide include staff absences due to sickness and the need to self-isolate, and workforce redeployment, for example from community to inpatient settings. in the community, staff in many countries have been required to limit face-toface contacts to essential tasks such as the administration of injectable medication [ ] . beyond the immediate changes to services seen in the early stages of the pandemic, there are many potential challenges that are specific to mental health care. these include difficulties in implementing infection control and social distancing guidance in settings where people may be very distressed or cognitively impaired [ ] , especially in mental health wards and the supported accommodation settings where many people with complex mental health problems live [ ] . face-to-face meetings are usually central to mental health care: severe restrictions to this seem likely to greatly alter staff and service user experiences. there is also a considerable risk that, even after restrictions are lifted, there will be a lasting exacerbation of health and social inequalities that affect people with longer term mental health problems, for example, through increased economic disadvantage, inequalities in health care, or sequelae of increased trauma and abuse [ , ] . since the start of the pandemic, experts from around the world have published views about potential negative impacts of the pandemic on mental health services [ , , ] and the suggestion has also been recurrently made that it could provide an opportunity for positive service developments [ ] [ ] [ ] . however, there is a lack of research directly assessing and reporting the experiences and perspectives of those currently working in the mental health system. our aim was to inform further research and service responses by conducting, in the early stages of the covid- pandemic, a survey of the perspectives and experiences of staff working in inpatient and community settings across the uk health and social care sectors. the king's college london research ethics committee approved this study (mra- / - ) , which involved mental health staff in the uk completing an online questionnaire. in the absence of a measure of pandemic impact on mental health care and mental health service users, we rapidly developed an online questionnaire to collect cross-sectional quantitative and qualitative data from mental health care staff. all staff working in face-to-face mental health care in the uk, or managing those who provide such care, were eligible to participate. all specialties were included, as were nhs, private healthcare, social care, and voluntary sector services. the lead developer of the questionnaire, sj, an academic and practising inner london psychiatrist, read key sources identified in an accompanying rapid review of relevant literature [ ] , including academic and professional journals, news media, and organisational websites, and followed relevant social media topics. the drafting of the questionnaire was further informed by the nihr mental health policy research unit (pru) working group for this study (about people, including clinicians, researchers, and people with relevant lived experience), and the pru lived experience working group. both groups discussed the study at online meetings and identified important topics for inclusion. nine further clinicians provided email summaries of the challenges which they were currently facing and how they were being addressed. feedback was obtained from the pru working group on a first draft of the questionnaire, together with additional input from experts in fields including mental health care for older people, children and adolescents, people with drug and alcohol problems, offenders, and people with intellectual disabilities. the questionnaire was revised and converted into an online format using the ucl opinio platform. pilot testing was then conducted with clinicians, who provided feedback on length, acceptability, and relevance, and on problems with specific items. following this, a final version of the questionnaire was agreed. a mixture of structured and open-ended questions was included. participants were asked which sector and region they worked in but not which organisation, maximising anonymity. participants could skip questions if they wished, and internet cookies were used to prevent participants completing multiple questionnaires. a branching structure was adopted, with initial questions asking all participants to rate the relevance of each item on lists of: -challenges at work during the covid- pandemic. -problems currently faced by mental health service users and family carers (from a staff perspective). -sources of help at work in managing the impact of the pandemic. this was followed by sections for staff in specific settings and specialties. questions also elicited details of adaptations and innovations introduced to manage the impact of the pandemic, and their perceived success, and enquired about concerns for the future and any aspects of current practise that they would like to keep after the pandemic. participants were asked between and questions depending on their eligibility for branching questions for specific settings or specialties. depending on the detail provided to open-ended questions, the survey typically took - min to complete. a copy of the survey is available at this web address: https ://opini o.ucl.ac.uk/s?s= . our aim was to achieve rapid recruitment of a large and varied sample by dissemination through multiple channels including: in the final week of recruitment, we targeted under-represented sectors, including relevant voluntary sector organisations and supported housing providers. we also sought to increase representation of staff from black, asian, and minority ethnic groups by focused social media recruitment via the mental elf, including a video in which a prominent black psychiatrist encouraged participation, and contact with the networks of pru researchers who work on issues of diversity. quantitative data: we aimed to give an overview of the impact of the pandemic. we produced descriptive statistics using stata to summarise relevant aspects of the quantitative data. missing data are reported in the footnotes of the relevant tables in the supplementary report. qualitative data: qualitative analysis was conducted to expand on quantitative findings [ ] . a preliminary analytical coding framework was developed by sj guided by the study research questions, quantitative analysis results, and themes emerging from the initial survey responses. the responses to open-ended questions were left unedited and compiled under topics relevant to the research questions. coding matrices were developed in microsoft excel, with the emerging codes in the columns and cases in rows. directed descriptive content analysis was then conducted [ , ] . for this, all survey responses were indexed in the coding matrices by a group of researchers, mostly phd students or researchers with relevant lived experience. topics that came up repeatedly in the data and could not be categorised with the initial coding framework were given a new code. coding work was coordinated by so (associate professor) and nvsj, uf, and ap (post-doctoral researchers) to increase consistency and accuracy when applying the predetermined codes, and to discuss adding codes to the initial framework when necessary. sj and as (clinical professors) helped to understand clinical contexts and resolve coding difficulties. finally, the coding team developed summaries of each code and presented these in tables ranked in order of frequency, shown in the supplementary report. involvement of this large team allowed us to complete analysis within weeks. we summarise key findings here: our accompanying supplementary report gives much more detail. data were collected from april to may . in total, , people started the survey (including many who clicked 'start' but provided no or minimal data) and , got to the end. we report results for participants who completed at least one question from each of the three main sections open to all respondents. this produced a sample of , . there were , responses to open-ended items, yielding , words for rapid qualitative content analysis. a large majority of participants worked in the nhs ( , , . %). approximately a third described themselves as nurses ( , . %), as psychologists ( . %), as psychiatrists ( . %), as social workers ( . %), and as peer support workers ( . %). over a third identified as a manager or lead clinician in their service ( , . %). over two-thirds worked with working age adults ( , , . %), . % worked with older adults ( ), just under a third worked with people with learning disabilities ( , . %), around a fifth worked with people with drug and alcohol problems ( , . %), and another fifth worked with people with eating disorders ( , . %). participants could report working with multiple service user populations and/or in multiple settings. the majority worked in england ( , , . %) with around a third of these based in london ( , . %) and a fifth in the north west ( , . %); three-quarters worked in cities or towns with populations greater than , ( , , . %). four-fifths were female ( , , . %) and almost nine-tenths were from white ethnic groups ( , , . %). full demographic details, including age, caring responsibilities, and covid- status, can be found in table x of the supplementary report (references to tables in the supplementary report are herein indicated with an 'x' after the table number to distinguish them from tables in the main text). participants rated a list of current challenges at work, some general and others setting-specific, on a five-point scale from 'not relevant' to 'extremely relevant'. table shows the five work challenges rated highest in each type of setting; tables x- x report this in further detail. in inpatient wards and crisis houses, infection control challenges, related to table top five rated work challenges* for each setting (see tables x- x and x- x in the supplementary report for further details) * includes 'current work challenges' (c) asked of staff from all settings and 'additional work challenges' (a) that are specific to each service type ** a respondent may work in more than one setting (e.g., an inpatient service and a crisis assessment service), but will provide only one answer per challenge *** the 'additional work challenges' (a) sections, which are specific to specific settings and specialties, appear in the survey after the 'current work challenges' (c) section, which is open to staff from any setting. therefore, the reduced n for a challenges compared to c challenges represents respondents who completed the first sections of the survey, but then did not go on to complete the later branched sections of the survey both service users and staff becoming infected, were rated highest, alongside increased boredom and agitation amongst service users due to lack of activity and contact on the ward. crisis service staff rated as most relevant lack of services to which they could refer on or signpost. community team staff rated items related to changes in ways of working and adoption of remote technologies highest, along with reduced availability of other services. the small group of residential service participants gave a high relevance rating to their environment being more challenging, because residents cannot go out and/or engage in usual activities. table x shows ratings by profession and table x shows ratings by managerial roles. there were fewer obvious differences by profession than by setting, but managers and lead clinicians more often reported challenges relating to supporting colleagues with stressors due to the pandemic, and increased workload during the pandemic as very or extremely relevant ( . % and . %, respectively) compared to those not in these roles ( . % and . %, respectively). half of staff in inpatient and residential settings reported that they could not consistently follow the rules set on infection control ( , . %), and just over a third reported that they could not do this in community and other settings ( , . %). table shows the impediments to this most often identified from qualitative content analysis of responses, with more detail in tables x- x. tensions between meeting clinical needs and infection control were reported across settings, for example in responding to emergencies on wards or when service users in the community needed home visits, on which infection control measures were very difficult to implement. the built environment was the most frequently cited challenge in the community, and ward layouts impeded infection control in hospital. in each setting, there were also reports of conflicting or unclear guidance. reports of not having the facilities and processes to adhere to guidance, for example in putting on and disposing of personal protective equipment (ppe), were especially prominent in the community. unclear or conflicting guidance and procedures, and service users who are unable to understand and adhere to infection control rules, were reported across settings. substantial numbers were also concerned about perceived conflicts between protective equipment and therapeutic relationships, for example when trying to engage service users with paranoid ideas while wearing a mask. we also asked participants to report, if data were available to them, the extent of activity change in the service in which they worked (table x ). responses varied, but reports of reduced activity considerably exceeded those of increased activity, especially regarding inpatient admissions (though less so for compulsory admissions) and new referrals to crisis services and community services. however, in community services, including psychological treatment services, similar numbers of staff said that they were having more weekly contacts as said they were having fewer. table summarises staff perceptions of the current relevance of various types of difficulty for the service users and carers with whom they were in contact (table x reports this in greater detail and by service user group). across all groups, staff tended to rate social difficulties as most relevant, for example, loneliness and lack of usual support from table top five reasons infection control rules could not be followed for inpatient and community settings* (with frequencies), responses to an open-ended question (see tables x- x in the supplementary report for further details) * a respondent may work in more than one setting (e.g., an inpatient service and a crisis assessment service) ** includes staff working in inpatient services, crisis houses, and residential services *** includes staff working in crisis assessment services, community teams and psychological treatment services, community groups, and other settings inpatient and residential settings** community settings*** family and friends. several other types of problem were also rated by many staff as very or extremely relevant, including lack of normal support from mental health and other services, deterioration in mental health in the pandemic period, worries about infection, and being at high risk if infected. responding to open-ended questions, staff identified a range of groups of service users about whom they were particularly concerned, some because of impacts on their clinical condition, others because of their social characteristics or circumstances, or because of specific difficulties providing an adequate service for them. table summarises groups frequently identified as of particular concern, and table x gives more detail. we also asked staff whether they were seeing people with mental health difficulties that appeared to arise from the pandemic (table x) . some described symptoms directly related to covid- , such as delusional beliefs regarding covid- infection or quarantine, and health anxiety or obsessive-compulsive symptoms related to infection. others described relapses in people who had long been stable that they felt were linked to the stresses of the crisis. some also reported apparently first presentations of mental health problems such as psychosis or mania among healthcare workers. table summarises responses to a question about which sources of help were currently most important to staff in managing the impact of covid- at work. across all professions, the most important sources of help were support and advice from employers, colleagues, and managers, closely followed by new digital ways of working and the resilience and coping skills of service users and carers, the latter presumably seen as making the crisis less burdensome for staff, at least at its onset. patterns of response were not markedly different across professional groups (tables x- x). table summary of staff perspectives on which of their service users' and carers' problems are most relevant, in order of % rated very or extremely relevant (n = , ) (see table x participants in crisis and community services were asked whether services they worked in had changed opening hours or locations, and how their practices had changed (table x ). services that had increased their hours during the crisis, for example with weekend opening, were described, as well as reductions in other services. most staff working in crisis services reported that home visits were continuing when strictly necessary. a mixture of responses was obtained from community services (including both community mental health teams and psychological treatment services), with some reporting continuing face-to-face contacts and home visits as needed, others having stopped them. responses regarding psychological treatment were split between aiming to provide a full table frequently cited examples of the groups of service users about whom staff participants have been especially concerned during the pandemic: qualitative content analysis of open-ended responses (see table x in the supplementary report for further details) people who are cognitively impaired (e.g., due to dementia or learning disability), who may find situation hard to understand and struggle to follow guidance people with psychotic symptoms that may be exacerbated by current events and interfere with their ability to follow guidance people with complex emotional needs (who may have a "personality disorder" diagnosis), who may be destabilised by abrupt loss of support and routines; people with anxiety or ocd, especially those for whom covid- interacts with contamination-related symptoms women with perinatal mental health problems, lacking usual support and assessment around the time of birth people with drug and alcohol problems, for whom treatment and support are often severely disrupted and following guidance may be difficult people with eating disorders, at risk from disruption to usual eating, exercise, and social routines and to food access people of concern due to impacts related to social circumstances or characteristics people who live alone/are currently socially isolated and lonely older people with mental health problems, due to loss of usual support (e.g., family visits) and additional physical health vulnerability people who are in households where there is domestic violence or conflict children in homes that may not be safe or where there is family conflict people living in poverty/poor housing, or who are homeless, for whom the lockdown is especially difficulty people of particular concern due to service disruptions inpatients who have experienced service disruptions, including precipitate discharge, delayed discharge because of infection concerns, lack of leave or visits, and increased isolation and lack of activity or therapies on the wards people who are difficult to reach in the community without usual visiting/outreach/face-to-face appointments and may not be seeking help that is needed people at risk because of disrupted availability of medical responses, e.g., for people who harm themselves and are discouraged from visiting/ reluctant to visit emergency departments open-ended questions elicited adaptations and innovations made to manage the impact of the pandemic (table x ). the most widely reported shift was greatly increased adoption of remote technologies, as discussed below. some participants also reported adopting new digital tools for assessment and therapy, such as apps and websites. other innovations included new crisis services, such as crisis assessment centres rapidly established as alternatives to hospital emergency departments and new crisis phone lines, and re-organised services, resulting in extended hours, increased access for specific groups, or shorter waiting lists (e.g., for psychological treatment). reported changes in the types of help offered included community services arranging practical help, such as food deliveries for service users, and providing resource packs to help service users to be active at home. also frequently described were new or expanded forms of support for staff, including 'wobble' rooms (quiet rooms for staff who feel overwhelmed), staff helplines, increased supervision, wellness check-ins, and more use of informal support mechanisms. also reported was a general shift towards a more flexible approach, reducing bureaucracy and removing barriers to change, leading to a more agile way of working and a more responsive service. many staff also valued the many benefits to their well-being, productivity and efficiency in being able to conduct some of their client contact or administrative tasks away from the office. further quantitative and open-ended questions explored views and experiences of the shift to remote working (tables x- x) . almost all staff in community services ( , , . %) , and a large majority in crisis services ( , . %), were replacing some face-to-face contacts with phone or video calls. the shift to video calls did not appear to have been very extensive, however, with the majority ( , . %) reporting use of this technology as their main means of contact with % or fewer of the service users with whom they have contact. views about this were mixed. video calls for communication between staff attracted the greatest enthusiasm, with more than two-thirds ( , . %) from both community and crisis services agreeing or strongly agreeing that they are a good way to hold staff meetings; this was echoed in open-ended questions. a majority ( , . % of respondents to this question) agreed or strongly agreed that video calls were a good way to assess progress of some people already known to the service, but only . % ( ) agreed or strongly agreed that they can be a good way of making the initial assessments. responses to open-ended questions ( table , tables x- x) likewise identified concerns about being able to make a good assessment remotely, as well as about forming rapport: they tended to suggest digital technologies were useful for clients with less complex needs, for "light-touch" interventions or for low-intensity therapeutic approaches and follow-up appointments. a majority ( , . %) agreed or strongly agreed that use of remote rather tables x- x in the supplementary report for further details) what's working well in tele-health what can prevent tele-health from working allows prompt responses saves travelling time is better for the environment may be more convenient for both staff and service users allows staff to connect easily with each other, even if based in different places and different teams allows home working best alternative for now: remote working is allowing services to keep going despite infection control restrictions innovative use of it and digital tools can allow group programmes or individual therapies to continue successfully benefits for some clients: some clients are happy with video-call technology and even prefer it access is improved for some people, especially if travel and public places are challenging may be an efficient way of helping people with less complex needs inadequate resources: equipment and internet connections of low quality processes and preferred platforms not clearly established staff may lack training and confidence impacts on communication and therapeutic relationships may be harder to establish and maintain a good therapeutic relationship may be harder to make an assessment, especially at first contact may be challenging for longer, more in-depth sessions digital exclusion: people who lack equipment and resources to connect people who don't have skills or confidence to connect (including people with cognitive impairments) people lacking a suitably private environment for remote appointments service user preferences: some service users strongly prefer confidential conversations to be faceto-face, or may feel suspicious or anxious about remote means if they do accept remote contacts, some prefer simpler phone or messaging modalities some service users do not engage with remote contacts than face-to-face consultations had resulted in not having contact with some service users who had not engaged with remote appointments. two-thirds ( . %) answered yes when asked whether they wished to retain longer term any changes made during the pandemic. table x summarises responses. a large majority involved keeping some aspects of remote working, with many feeling that selective use of technology platforms to connect staff with each other and with service users has potential long-term benefits for efficiency and the environment, particularly if technical difficulties are resolved and appropriate protocols developed. others wished to retain some new service initiatives, such as crisis centres in the community, or the increased flexibility and ease of making changes experienced at this time. responses to a question about concerns for the future were numerous and detailed (table x) . while many participants reported that referrals to their service had decreased in the early phase of the pandemic, many feared that need would increase significantly in future and that lack of capacity and staff burnout may impede response to this. anticipated drivers of increased future need included traumas, bereavement, and complex grief experienced by frontline staff, service users, and the wider public; mental health problems not managed effectively among people who have disengaged or not sought help during the pandemic; increased levels of domestic abuse and family conflict; and the effects of wider societal disruption and increased inequalities due, for example, to unemployment and homelessness. fears were also expressed that reduced levels of service might persist inappropriately after the current emergency period, that changes made in response to the crisis might be used to justify reduced funding in future, or that staff would be expected to continue with working patterns that they had agreed to only because of the crisis. extension of remote working beyond the circumstances in which it had proved helpful was a further concern. several respondents were concerned about the disproportionate impact of the pandemic on black, asian, and minority ethnic staff and service users, and about potentially increased racism and xenophobia. a wide range of challenges are reported by practitioners across the mental health sector, some specific to service settings or groups of service users and carers. while many commentators have predicted a significant and widespread impact of covid- , we are able to provide a more detailed report that is rooted in direct experience of the effects of the pandemic on mental health care, albeit only in one country and only from the perspective of practitioners. in the context of the pandemic, infection control is an immediate need whose complexity in mental health settings is a significant finding from our study. lack of ppe was sometimes identified as a problem. more prominent, however, were challenges relating to processes, to the physical environment in which mental health care is delivered, and to tensions between infection control requirements and providing safe care and maintaining therapeutic relationships with people who may be distressed, suspicious, or struggling to comprehend the situation. inpatient and residential services, and crisis services, where continuing face-to-face contacts appear more frequent than in routine care, are not surprisingly the settings in which staff are most immediately concerned with the spread of infection: the price of failure is potentially very high, as indicated by a recent care quality commission report on excess deaths related to covid- among people subject to the mental health act [ ] . the shift to remote working, strikingly rapid given that tele-health has been discussed over many years but with limited implementation, has been widely discussed; we examine staff perspectives on this in detail in the current study. both our quantitative and qualitative data suggest clear support for its partial adoption in the longer term: remote contacts are seen as valuable for staff meetings, and for convenient and environmentally friendly follow-up of well-engaged clients with access to and a positive view of technology. however, staff give a very clear warning that there are still important technological, social, and procedural barriers to be addressed, and that its use should remain selective, complementing rather than replacing face-to-face contact. this and other innovations that we document above suggest that, as in other domains of healthcare, there has been considerable agility and flexibility in at least some service contexts during the current crisis, with urgent needs overcoming well-documented barriers to implementing new ways of working. however, while responses to our question about innovations that staff would like to retain were numerous, serious concerns regarding both the short and long-term future were also widely expressed: these data were collected at a very early stage in the covid- pandemic. mental health services in the uk were already under pressure prior to the pandemic [ ] and swift attention, strategic planning, and resources will be required to meet widely anticipated additional demands from people affected directly or indirectly by the impact of the pandemic. this is only one perspective on the impact of the pandemic on mental health care, albeit one rooted in direct experience: it will be essential to investigate service user and carer perspectives, and to measure impacts on the mental health system more systematically as further data become available. given the unprecedented pace of change in the world and in mental health services, we prioritised gaining a broad overview of impacts and responses, but much detail will have been missed. our questionnaire was by necessity an ad hoc and not an established and validated tool. omissions were noted as the study progressed: it was assumed that impacts of the "lockdown" for service users were negative, but positive experiences are noted too, for example of reduced pressure or easier access for people who struggle to travel [ ] . more importantly, we designed the questionnaire early in the pandemic when the evidence of differential effects on some ethnic groups was less striking [ ] : closed questions do not focus on this, although these effects and issues of racism are included in open-ended responses on concerns for the future. our sample, gathered by disseminating our questionnaire through a range of channels, is not representative of those who work in mental health care settings, and may either over-represent people who have strong concerns about the situation or those who wish to report successful new practices. we managed to include a range of professions and work settings, but did not recruit as successfully as we had hoped outside the nhs-more targeted efforts and time are likely to be needed to reach relevant staff from other sectors. many people with mental health difficulties also come into contact with gps, pharmacists, paramedics, and a&e doctors and nurses, especially if they are not under secondary services; we have not included these perspectives. we are especially concerned that, while we do not have any definitive overall figure for the uk mental health care workforce, it is clear that the number of non-white participants in our survey is relatively small, despite targeted efforts to increase their number and a strong emphasis on anonymity and confidentiality, as advised in the previous discussions of this frequently experienced difficulty [ ] . further efforts to engage and form partnerships are likely to be needed here too. london also appears over-represented and rural areas, which may have distinctive challenges, under-represented, and we have not at this stage disaggregated data by country, region, or area type. we present here a series of snapshots capturing, from a staff perspective, the situation in mental health care services in the rapidly evolving early stages of the covid- pandemic. this work cannot yield definitive answers and should be interpreted alongside other perspectives, but offers researchers, service commissioners, managers, and policy makers directions for service development and further rapid research. regarding immediate priorities, our findings point to specific challenges to be addressed to achieve more successful infection control. remote working is a further immediate focus for research and service developments. participants' accounts suggest that it has been helpful in keeping services going and maintaining some level of contact in the community, and aids communication between staff. there is now a need to develop clearer processes in collaboration with service users for its targeted use, to implement guidance and evidence that already exists [ ] , and to explore ways of overcoming barriers to its effective use. mental health providers in the uk and elsewhere have demonstrated unprecedented capacity for rapid adaptation and innovation during the early pandemic period. recovery from the pandemic is a potential opportunity to establish new ways of working, for example with greater co-production with service users, and more widespread implementation of effective interventions and technologies [ ] . this will require sufficient resources, rapid production and translation of evidence, effective planning that engages all stakeholders, and great attention to workforce support and prevention of burnout. it is reassuring to see that staff share many of our concerns about the covid- pandemic: premature discharges, isolation, difficulties with infection control, and accessing care. many of these are reflected in the madcovid project's materials (https ://madco vid.com/). telemedicine drew mixed views from staff; we would like to highlight some difficulties. not everyone has a safe space to speak, may only have privacy in their bedroom or none at all. telemedicine works better for those in better, not-overcrowded housing, so risks widening inequalities in access to care. for many of us, our home is our safety, and it is important to have distressing conversations elsewhere. leaving the therapy room, we can leave some of our trauma behind. video calls may feel invasive-as though the clinician is in your bedroom-bringing up traumatic issues inside the home, where we cannot escape them. any continuation of remote working will need to consider the safety implications of this, assessing its suitability for each individual. it is vital that difficulty adhering to infection control guidance does not lead to blaming inpatients for viral spread. this is particularly important with restraint, where staff mentioned struggling to put on appropriate ppe in time to deal with an unfolding emergency. wide area variations in restraint rates (https ://www.mind.org.uk/media -a/ /physi cal_restr aint_final _web_versi on.pdf [ ] ; https ://weare agend a.org/ wp-conte nt/uploa ds/ / /restr aint-foi-resea rch-brief ing-final .pdf [ ] ), alongside personal experience, make us question whether restraint is ever truly unavoidable. if it places both staff and service users at risk of covid- infection, it is doubly dangerous. however challenging the situation, efforts must be renewed to reduce the iatrogenic distress, fear, and anger which can lead to its use. historically slow-moving services have implemented change at breakneck speeds in response to this crisis despite significant difficulties. service users have campaigned for changes for decades. it is time to implement these changes with the same urgency. the survey dataset is currently being used for additional research by the author research group and is, therefore, not currently available in a data repository. a copy of the survey is available at this web address: https ://opini o.ucl.ac.uk/s?s= . conflicts of interest sj, as, ble, so, and sc are grant holders for the nihr mental health policy research unit. ethics approval the king's college london research ethics committee approved this study (mra- / - ). consent to participate information on participation was provided on the front page of the survey. by starting the survey, participants agreed that they had read and understood all this information. it was explained on the front page of the survey that responses may be used in articles published in scientific journals and that these articles will not include any information which could be used to identify any participant. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/ . /. psychiatrists see alarming rise in patients needing urgent and emergency care and forecast a 'tsunami' of mental illness the lancet psychiatry. mental health and covid- : change the conversation ( ) mental health in the age of coronavirus: time for change. social psychiatry and psychiatric epidemiology the covid- global pandemic: implications for people with 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document analysis using mixed-methods sequential explanatory design: from theory to practice using the framework method for the analysis of qualitative data in multi-disciplinary health research three approaches to qualitative content analysis our concerns about mental health, learning disability and autism services funding and staffing of nhs mental health providers: still waiting for parity. the king's fund disparities in the risk and outcomes of covid- increasing response rates amongst black and minority ethnic and seldom heard groups video consultations: a guide for practice how mental health care should change as a consequence of the covid- pandemic physical restraint in crisis: a report on physical restraint in hospital settings in england briefing on the use of restraint against women and girls key: cord- -x yw authors: banskota, swechya; healy, margaret; goldberg, elizabeth m. title: smartphone apps for older adults to use while in isolation during the covid- pandemic date: - - journal: west j emerg med doi: . /westjem. . . sha: doc_id: cord_uid: x yw the maintenance of well-being, healthcare, and social connection is crucial for older adults (oa) and has become a topic of debate as much of the world faces lockdown during the coronavirus disease (covid- ) pandemic. oas have been advised to isolate themselves because they are at higher risk for developing serious complications from severe acute respiratory syndrome coronavirus. additionally, nursing homes and assisted-living facilities across the country have closed their doors to visitors to protect their residents. mobile technology such as applications (apps) could provide a valuable tool to help families stay connected, and to help oas maintain mobility and link them to resources that encourage physical and mental well-being. apps could address cognitive, visual, and hearing impairments. our objective was to narratively summarize apps that address physical and cognitive limitations and have the potential to improve oas’ quality of life, especially during social distancing or self-quarantine. in january , the first case of coronavirus disease was identified in the united states. shortly thereafter, visitation restrictions and guidance to reduce contact with older adults (oa), ≥ age , were put in place at many facilities caring for oas with the aim to protect them from infection. [ ] [ ] [ ] according to the world health organization, the case fatality rate for covid- in older adults in china years and older was . % compared to . % for people of all ages with no underlying health conditions. however, as many state and civic leaders are now debating lockdowns many oas may lack the assistance they need at home or in facilities to meet their daily needs. self-imposed and/or institution- in this narrative review of apps for oas, we aimed to find apps available to oas on the apple store that could potentially facilitate health during times of social distancing and/or selfquarantines. these apps were curated by a research team that included an emergency medicine attending and physician scientist in geriatrics and digital health, a medical student, a graduate student in biotechnology, and others. the apps are categorized by common healthcare needs within the oa population addressed by the following categories: ) social networking; ) medical, with subcategories a) telemedicine and b) prescription management; ) health and fitness; ) food and drink; and ) visual and hearing impairment. app categories were determined based on app categories already in place on the apple store, with the exception of a category to address the specific needs of oas with visual and hearing impairment, for which we did a custom search using the terms "blind" and "deaf" details about the app developer, cost (both to download and for services included in the app), function, ratings and reviews, and user experience (in the form of anecdotes) were searched and summarized. all app rating and review data was last updated to this article on march , . in the final list of apps, we aimed to include those that are either designed to target the oa population or have features that could benefit oas during pandemics and outbreaks when social isolation and/or self-quarantine is encouraged. apps with broad acceptability were given priority. hence, apps needed a rating of . or higher and at least reviews on the apple store. exceptions were given for apps with broad appeal and applicability to the objective, such as facetime, medisafe, and apps that assist people with vision and hearing impairment, as shown in figure . apps were further screened based on function and then ranking. users' experiences of the app were given consideration during the selection; hence, recent customer reviews that demonstrated that the app was a valuable product for an oa were selected and summarized as anecdotes. we conducted a literature review using pubmed and google scholar on the topic, but as many apps are not rigorously tested for usability and efficacy in the oa population, this selection was mainly based on expert review. we list several apps that assist oas with daily needs. these are summarized by cost and intended use in table . user ratings and reviews, in the form of anecdotes, are provided in table . many apps are available to help oas navigate isolation during the covid- pandemic. while not all of the apps on our list are marketed specifically to oas, we include apps with broad acceptability and positive user experience to ensure a list that helps access healthcare, maintain mental and physical the impact of social isolation on health could be as harmful as traditional risk factors such as high blood pressure, smoking, and obesity. even before covid- , % ( . million) of oas were living alone. social isolation has been linked to physical and cognitive conditions including heart disease, high blood pressure, anxiety, depression, alzheimer's disease, and a weakened immune system. fortunately, mt could provide a solution to isolation by enhancing the connection with loved ones in a safe and easy way, through apps such as facetime and skype. although mt cannot replace face-to-face interaction, it can still provide ease for those who feel a loss of connection. oas who use video chat apps, including facetime and skype, are estimated to decrease their symptoms of depression by half. in a survey of oas, those who use video chats were found to have lowered probability of depression symptoms, whereas depression rates among oas who use instant messaging and social media networks were similar to oas who do not use any communication technology. skype is the oldest video chat app that offers the widest device support, including for android, ios, windows phone, and blackberry. it can run on desktop software including windows pc and apple's macbook. nursing homes and oa living residences frequently use skype to connect oa residents to their loved ones, even though the app takes some explanation to learn the software so users can fully understand how to use it. additionally, per recent policy changes by the us department of health and human services (hhs) office for civil rights (ocr), medicare beneficiaries may have improved access to their medical providers through facetime and skype by approving reimbursement at the same rate for an in-person as a telemedicine visit. food and drink apps on the apple store can be a solution for vulnerable populations as users have access to same-day delivery services such as doordash and instacart, allowing them to remain in their homes and maintain social distance. doordash has implemented "no-contact delivery options" as a response to covid- . the app allows users to fill out personalized delivery instructions, requesting drivers to leave orders outside to avoid person-to-person contact. users have the ability to text pictures and/or descriptions to where drivers should place their order, which may be easier for some than typing due to the loss of dexterity with aging. due to the closure of many restaurants, individuals should verify that a restaurant is open before placing an order. instacart, a grocery delivery service, has seen a surge in demand for the month of march due to covid- , especially in states with an increased number of cases, and also promises dropoff delivery that minimizes contact. these apps can cater to the oa population by giving them the option to stay home or providing families with the option to order food for their older loved ones rather than deliver it on their own, if they themselves are in quarantine. appropriate apple store app categories: ) social networking; ) medical; apps with features that could benefit older adults during covid creation of a custom app category (apps for visual and hearing-impairment) due to relevance to vulnerable population and older adults apple store searched using terms "blind" and "deaf" app ratings ≥ . and ≥ , reviews on the apple store exceptions • facetime was included due to known popularity and use • medisafe was given an exemption from exclusion due to known beneficence from background literature search health, and meets oas' various social and functional needs during social distancing during the covid- outbreak. these apps could also provide oas fearing loss of independence a sense of purpose and control over their life and health. social isolation and self-quarantine, whether it is selfimposed, legally and/or institutionally mandated, can lead to negative impacts on an oa's mental and physical well-being. banskota et al. free to download app. app works with or without insurance and is available at reduced rates through many major health plans and large employers. the average cost of a video consultation copay with insurance is $ , and $ flat rate fee without insurance. per cms guidance, telehealth is covered at the same rate as in-person visits during the covid- crisis. provides face-to-face digital connection with a doctor, psychiatrist or psychologist through video on people's iphone or ipad; provides urgent care, behavioral health, preventive health, and chronic care management; provides services in many languages when appointment is scheduled. allows you to send "lightning-fast" video messages, enabling ondemand communication using sign language and visuals. medical apps: telemedicine apps (doctor on demand, teladoc, and k health: primary care) as a covid- response, hospitals and clinics across the country have started to defer elective appointments and surgeries. , oas may benefit from this restriction due to reduced exposure to the virus, but many have chronic health conditions that need to be addressed. telemedicine may provide a temporary solution for these needs. the centers for medicare & medicaid services' recent expansion of medicare coverage for telehealth services to its beneficiaries provides an alternative for in-person medical care, and the waiver of medicare's cost-sharing requirements for covid- will improve access to care. social networking "skype is easy and good to use in terms of functionality and interface. i use skype phone to call international phones because the rate is very reasonable" ("good and easy to use," ). medical apps: telemedicine teladoc . stars; k ratings; # in medical "this has become my go to for our family. we never have a long wait, the doctors are knowledgeable and we get our prescriptions right away. this service provides massive value" ("always reliable," ). k health: primary care . stars; k ratings; # medical "all of my kids were diagnosed with the flu. discovered this app and wow it was a lifesaver. spoke to the doctor and got my rx without having to leave the house" ("great for sick mom," ). doctor on demand . stars; k ratings; # medical user did not have to leave home to get an antibiotic prescription at a local pharmacy, and reported, "what a fantastic service!" ("amazing," ). goodrx-save on prescriptions . stars; k ratings; # in medical a patient was paying $ dollars for a prescription until they switched to goodrx. now they are only paying $ for the same medication ("saving $$$," ). medisafe medication management (medisafe) . stars; k ratings; # in medical "my wife just came home from hospital with medications from specialists and medication from a primary doctor. i struggled to keep up until i started this app" ("couldn't do without this app," ). health & fitness apps calm . stars; k ratings; # in health & fitness "i struggle with anxiety anyway, and with a pandemic upon us, i've enjoyed using calm as a tool. i've used it during the day to deepen my meditation and yoga" ("helpful," ). headspace: meditation & sleep . stars; k ratings; # in health & fitness "...headspace is always my go-to for high quality soothing meditations. it has helped me calm down in the covid- crisis, and headspace is none other" ("life-changing," ). yoga: down dog . stars; k ratings; # health & fitness user states "this app helped improve my physical and mental well-being. i was able to start to learn more about yoga, build core strength, and flexibility" ("great for beginners," ). glide-live video messenger . stars; k ratings; no ranking "i use this app fairly regularly to communicate via als. it works great and i love the many features" ("great for asl," ). will not conduct audits to ensure this), and that "providers must use an interactive audio and video telecommunications system that permits real-time communication." medical apps that provide telehealth could facilitate care "early during the course of an acute problem or chronic disease exacerbation," and provide healthcare access to those patients who have never had a prior correspondence with a provider. , these resources could be valuable to uninsured and undocumented oas in the us. , these platforms may also be viewed as an extra resource that provide patients, especially those living in medically underserved areas, where access to care is limited. these platforms can connect patients to remote physicians during emergency closures and during times of increased demand for medical services. for example, during hurricanes harvey and irma, doctor on demand offered visits for chronic conditions, advice, counseling, and refills, and back and joint concerns. doctor on demand, teladoc, and k health: primary care are options available on the apple store that provide access to licensed physicians for non-emergency medical problems and are health insurance portability and accountability act of (hipaa) compliant. [ ] [ ] [ ] doctor on demand and teladoc are considered leaders in telemedicine, and are covered by many insurances including unitedhealthcare, aetna, cigna, and some state medicaid programs, although coverage may be different, and different insurances have different preferred telehealth destinations. , [ ] [ ] [ ] [ ] it is also important to note that many states have made changes to their telemedicine license policies due to covid- . , the fact that our healthcare system was not equipped to provide telehealth on a mass scale for an outbreak is demonstrated by the waiver of penalties for hipaa violation for using "everyday communication technologies such as facetime and skype" to provide medical care during the covid- emergency. in contrast, smartphone apps we have listed that provide telehealth services ensure hipaa-compliant services, which may be preferred by some patients with privacy concerns. telemedicine has not always been embraced as a viable solution for patients. providers in these platforms do not have access to key information from physical examination and diagnostic testing; in addition, they lack access to care coordination and insight gained from longitudinal care. , however, telemedicine may be the only viable solution during covid- , and many experts predict oas could benefit long term from the improved access to care these platforms provide. telehealth clinicians have experience working with limited exam and diagnostics tools and should acknowledge when an actual visit is necessary due to the acuity of the condition or the need for an in-person exam or procedure. patients are generally satisfied with telehealth service use. , therefore, access to care during this time may contribute to reduction of anxiety and frustration, in addition to feelings of loneliness, in the oa population. it is important to note that racial disparity is known to exist in telemedicine access, as well as that the majority of current telemedicine users are younger adults. therefore, ensuring equity in telemedicine access is important during this crisis, along with special effort in introducing and orienting oas from underrepresented backgrounds. in adults years and older, more than % use two or more prescription drugs and % used five or more (called polypharmacy). furthermore, per the kaiser family foundation, "about one-fifth of older adults report[ed] not taking their prescribed medication as prescribed due to cost." goodrx provides discounts on medication, which could be particularly useful for oas with a limited budget or high out-of-pocket costs due to being on multiple medications. according to an aarp survey, % of midlife adults provided regular financial support for basic necessities to their parents regularly in , and more than a quarter of these adults reported that this caused them financial strain. hence, goodrx may be useful for adults financially supporting older parents, and for working americans laid off due to business shutdowns. this is also a time when family members and caregivers who typically visit oas and check on their medications are unable to do so because of social isolation and visitor restrictions at nursing homes and assisted living facilities. medisafe could help oas with trouble adhering to a medication regimen due to cognitive impairment or polypharmacy. self-reported medication nonadherence is common in community-dwelling older adults especially in those with cardiovascular disease. cardiovascular disease is a known risk factor for mortality among oas who contract covid- . medication nonadherence itself can be dangerous, as it contributes to more than % of hospital admissions in older adults, and is associated with increased incidence of heart failure. , hospital admissions may increase risk of exposure to covid- , and heart failure is associated with worse prognosis in oas with covid- . thus, oas should be especially careful about medication adherence during this pandemic to protect health. in one study, participants using medisafe had a small improvement in self-reported medication adherence. therefore, medisafe, along with its real-time missed medication alerts and frequent check-ins via phone calls by family members or healthcare providers, may help oas stay in the path of medication adherence. in , medisafe announced a partnership with goodrx to help lower medication costs. medisafe along with goodrx could help reduce barriers to medication adherence. oas are prone to worrying about their health. anxiety could be exacerbated during the covid- crisis. health anxiety has been found to be associated with more "distress, impairment, disability and health service utilization." this finding underscores the importance of curating apps targeting health applications for oas mental health. a study shows that oas are "motivated to use digital technologies to improve their mental health." in a study with participants aged - , frequent use of headspace for days was associated with improvement in mental health, specifically depressive symptoms and resilience. in another study among college students, students who used calm for eight weeks reported reduced stress. although there has been no published research looking at the effectiveness of using applications such ase calm and headspace in oas, these apps could be a useful tool to address anxiety. social isolation and quarantine can decrease physical activity and promote sedentary behavior, which is problematic in a population that already spends % of awake time engaged in sedentary activities. sedentary behavior is associated with disability in activities of daily living, development of metabolic syndrome, and an increased risk of all-cause mortality in the elderly. long duration of sitting is negatively associated with femoral bone mineral density (fbmd) in women, whereas duration of light intensity physical activity is positively associated with fbmd. physical activity intervention has been proven effective in improving physical activity behavior in healthy oas, and most sequences of yoga are classified as a light-intensity physical activity. , some small studies also suggest that, in oas, yoga may be superior to conventional physical-activity intervention. suggesting healthy oas to use an app such as yoga: down dog could reduce the ill-effects of sedentary behaviors. encouraging oa users to set a goal to pursue daily physical activity during social isolation and may serve as behavior intervention. yoga could protect psychological health in this difficult time, and help with sleep quality. , in a study in oas, chair yoga participants had more improvement in anger, anxiety, depression, well-being, general self-efficacy, and self-efficacy for daily living than control and chair exercise participants. chronic conditions common in oas, such as hypertension and diabetes, can be controlled with exercise and good diet. myfitnesspal, which provides a calorie counter and diet plan, could be a motivator for behavior change. myfitnesspal is a behavior intervention that could provide benefit of well-being, but it requires self-efficacy. , limitations of myfitnesspal include unreliable estimation of (micro-) nutrients ingestion and ineffectiveness in patients without goals and willingness to self-monitor calories. [ ] [ ] [ ] [ ] therefore, although myfitnesspal may be recommended to promote healthy behavior, oas should not use myfitnesspal by itself, and work in conjunction with a dietitian if possible. when asked about the vulnerable populations that have an increased risk of being affected by covid- , dr. lisa cooper of johns hopkins reported that individuals with vision and hearing impairments are also vulnerable. as of , an estimated four million oas had vision disability. vision impairments double the risk of falls, which one of four oas experience, and are associated with morbidity and mortality. oas with vision impairments who live alone and do not receive any caretaker service have to overcome greater challenges regarding activities of daily living and instrumental activities of daily living, which limits one's quality of life and independence. be my eyes, the largest online support for the visually impaired, may be a useful resource to these oas, especially at this time. , per be my eyes, over two million volunteers speaking over languages have signed up on the app to assist those with impairments, increasing acceptance, socialization, and independence for this population. , with the goal to help visually impaired individuals navigate through daily activities, volunteers have the ability to assist oas who do not have support at home by keeping them safe, enabling users to have a sense of independence and support. , an estimated one in three people between the ages - have difficulty hearing, with half of those older than having difficulty hearing. oas with hearing impairment have a greater chance of becoming depressed due to feeling frustrated and embarrassed about not understanding what is being said. howard a. rosenblum, chief executive officer of the national association of the deaf, stated that the us government must make information on covid- accessible in american sign language (asl), including information on how the virus affects education and employment access, among others. glide -live video messenger enables the ability to communicate to the hearing-impaired population through asl and/or just videos. this may negate feelings of loneliness and depression during times of social distancing for covid- . additionally, important information pertaining to disease characteristics, local and state business closures, financial updates, and other communications on covid- could be shared to those with hearing impairments effectively and promptly using glide. our summary of the apps, listed in figure , was based on the functionality of apps on the apple store primarily using the "top charts" list and expert opinion. rather than creating an exhaustive list, we focused on a brief list of apps that could be recommended to oas during the covid- pandemic. apple store is not accessible in all smartphones, and there is a far greater ownership rate of android devices compared to ios. however, except for facetime, the other apps on our list can also be found on google play store, the android app store. it is important to note that because app features may differ slightly on the two operating systems, user experience and ratings for the apps may vary between the two digital-distribution platforms. due to the limitations in our methodology, our apps list does not address the barriers faced by older adults with hearing impairments but without experience using sign language. for these older adults, live captioning apps such as ava, otter.ai, and microsoft translator may be suggested. these apps can be downloaded on both ios and android devices. while microsoft translator is a completely free, ava and otter.ai is free for occasional use, which limits users to hours/month and minutes/month, respectively. unlimited access can be purchased with a subscription to premium plans. it is also critical to acknowledge that while digital health and mt use by oas is increasing, few apps have been reviewed and tested for usability and efficacy in clinical trials among the oa population. in the future, additional research assessing the usability of these apps in the oa population using the mobile app rating scale, or other usability models such as the technology acceptance model, should be conducted. , however, many of the apps we have suggested fulfill an unmet need and could help oas maintain physical and mental health, independence, address disabilities, and some financial security. most importantly, they encourage and allow for a less imprisoning and isolating experience for oas during this crisis. apps are inexpensive and accessible, and research has shown that oas can use smartphones when provided the necessary training. there is an increase in the use of smartphones in the aging population. recommending these apps, along with providing some training and guidance, to an oa could help decrease loneliness and maintain and/ or improve the health and independence of oas during the covid- pandemic. while apps cannot substitute for all in-person care, they could supplement or substitute some inperson care. this publication was made possible by the national institute on aging (r ag ; k ag ), and the brown physicians, inc. academic assessment research award (pi: goldberg). the authors would like to thank armen deirmenjian and kunzhao li for support during the initial process of apps selection. nursing homes becoming islands of isolation amid 'shocking' mortality rate. the new york times families worried about loved ones in nursing homes amid coronavirus preparing for covid- :long-term care facilities, nursing homes covid- ) pandemic. world health organization mobile support for older adults and their caregivers: dyad usability study designing interpersonal communication software for the abilities of elderly users social isolation, loneliness and health in old age: a scoping review can digital technology enhance social connectedness among older adults? a feasibility study the effect of information communication 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requirements/renewals in response to covid- telemedicine spreads rapidly, but some physician groups worry about quality of care electronic visits for common acute conditions: evaluation of a recently established program patients' satisfaction with and preference for telehealth visits prescription drug use continues to increase: u.s. prescription drug data for data note: prescription drugs and older adults | the henry j. kaiser family foundation. kaiser family foundation a survey of midlife adults providing financial support to family members layoffs intensify leading to soaring unemployment claims as coronavirus business closures continue prevalence and correlates of self-reported medication non-adherence among older adults with coronary heart disease, diabetes mellitus, and/or hypertension are you at higher risk for severe illness? | cdc medication non-adherence among older adults: a review of strategies and interventions for improvement medication nonadherence: an unrecognized cardiovascular risk factor association of a smartphone application with medication adherence and blood pressure control: the medisafe-bp randomized clinical trial medisafe partners with goodrx to help app users lower medication costs -medisafe worry and use of coping strategies among older and younger adults health anxiety in australia: prevalence, comorbidity, disability and service use older adults' perspectives on using digital technology to maintain good mental health: interactive group study mobile mindfulness meditation: a randomised controlled trial of the effect of two popular apps on mental health efficacy of the mindfulness meditation mobile app "calm" to reduce stress among college students: randomized controlled trial smartphone applications for mindfulness interventions with suicidality in asian older adults: a literature review amount of time spent in sedentary behaviors in the united states sedentary behavior and health outcomes among older adults: a systematic review associations between objectively-measured sedentary behaviour and physical activity with bone mineral density in adults and older adults, the nhanes study interventions to increase physical activity among older adults: a meta-analysis a systematic review of the energy cost and metabolic intensity of yoga the effects of yoga on physical functioning and health related quality of life in older adults: a systematic review and meta-analysis effects of yoga on psychological health in older adults more than i expected": perceived benefits of yoga practice among older adults at risk for cardiovascular disease most common chronic diseases -healthy aging blog | ncoa. ncoa. available at the effects of choice and enhanced personal responsibility for the aged: a field experiment in an institutional setting the relative validity of a food record using the smartphone application myfitnesspal popular nutrition-related mobile apps: an agreement assessment against a uk reference method comparing 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study technology use among seniors | pew research center key: cord- -y rfj authors: waiswa, c.; azuba, r.; makeba, j.; waiswa, i.c.; wangoola, r.m. title: experiences of the one-health approach by the uganda trypanosomiasis control council and its secretariat in the control of zoonotic sleeping sickness in uganda date: - - journal: parasite epidemiol control doi: . /j.parepi. .e sha: doc_id: cord_uid: y rfj elimination of sleeping sickness from endemic countries like uganda is key if the affected communities are to exploit the potential of the available human and livestock resources (production and productivity). trypanosoma brucei rhodesiense, the parasite that causes acute sleeping sickness in humans, is transmitted by tsetse flies and co-exists in non-human animal reservoirs. uganda by act of parliament in decided to handle the complex approach to control of sleeping sickness and animal trypanosomiasis by establishing the uganda trypanosomiasis control council (utcc) and its secretariat the coordinating office for the control of trypanosomiasis in uganda (coctu). the institutional arrangement aimed to promote engagement with key stakeholders across nine key ministries and the community, all vital for control of zoonotic sleeping sickness, creating a one health platform, long before such practice was common. from , approaches by the public private partnership, stamp out sleeping sickness (sos) have required involvement of stakeholders in the promotion of insecticide treated cattle as live tsetse baits, targeting elimination of zoonotic sleeping sickness. experiences in promoting sustainability of these interventions have been captured in this study as part of the tackling infections to benefit africa (tiba) partnership. meeting transcripts, focus group discussions and questionnaires were used to collect data from the different stakeholders involved in a rapid impact live bait study over months from dec . the study provides unprecedented insights into the stakeholders involved in the application of a one health approach for control of zoonotic sleeping sickness across the most important active human african trypanosomiasis focus in east africa. this unique study is fundamental in guiding multi-stakeholder engagement if the goal to eliminate zoonotic sleeping sickness is to be realised. a major challenge is timely feedback to the community as regards human and animal disease status; rapid diagnostic services that can be delivered from facilities established in close proximity to the affected communities and well equipped in-country reference laboratories are key to delivering effective control and best one health approach. trypanosomiasis significantly reduces productivity of millions of cattle, sheep and goats (leigh et al., ; nyimba et al., ) . in africa, many areas infested by the tsetse fly vector, also have trypanosomiasis affecting humans with uganda as the only country affected by both acute (trypanosoma brucei rhodesiense) and chronic (trypanosoma brucei gambiense) types of sleeping sickness. a decade ago, uganda represented a region of potential overlap, with the two focuses (the chronic type affecting the west nile region and the acute type that affects the south east and northern regions of uganda) expanding towards each other (picozzi et al., ) . moreover, the trypanosome species that causes acute trypanosoma brucei rhodesiense (tbr) sleeping sickness in humans co-exists in non-human hosts (tsetse, wildlife and domestic animals) with a number of other non-human infective pathogenic trypanosomes (waiswa et al., (waiswa et al., , waiswa, ) . for uganda, tsetse infestation and areas endemic for human and animal trypanosomiasis cover about % of the country (albert et al., ) , where millions of both livestock and human are exposed to the disease. t. vivax, t. congolense and t. brucei sl infections are common among cattle (selby et al., ; muhanguzi et al., a) . among human infections, over % of reported t. b. rhodesiense cases in the whole of africa between and were from uganda (simarro et al., ) and this emphasised the earlier suggested need for a strategy of an integrated disease control approach (welburn et al., ) . multi-stakeholder engagement and involvement in designing solutions for a disease that affects human, livestock and wildlife in uganda has been a key function for the uganda trypanosomiasis control council (utcc) and its secretariat coordinating office for control of trypanosomiasis in uganda (coctu) since (utcc act, ) . in addition, since , several initiatives have been deployed especially treatment of diagnosed human sleeping sickness cases and use of live bait in cattle to control the zoonotic form of sleeping sickness (kabasa, ; waiswa and rannalette, ; waiswa and kabasa, ) . the stamp out sleeping sickness (sos) intervention treated > , cattle in seven districts in northern uganda over two phases since . following establishment of the private public partnership through the sos consortium, trypanosome prevalence reduced by % through mass treatment alone, with reduction in human sleeping sickness cases by % (welburn and coleman, ) . published data concluded that the sos intervention resulted in a significant decrease in the prevalence of t. brucei s.l. and human infective t. b. rhodesiense infection in village cattle and this is estimated to have saved between $ - million in human health care costs by avoiding the overlap of the two forms of human african trypanosomiasis (welburn and coleman, ) . the restricted application of insecticide using cattle as live bait for tsetse protocol (rap) implemented through sos has also generated increased productivity of $ per head of cattle per year and mean annual income per household of $ in poor communities okello, . given that approximately a million cattle are treated annually (waiswa and wangoola, ) , this is $ million per year in terms of increased productivity in impoverished communities of uganda. this live bait approach continues to be used, in addition to both passive and active surveillance plus treatment of the human cases of sleeping sickness. similarly, utcc advocates for an integrated pest management (ipm) approach where other tools like awareness, use of tsetse fly traps and targets (lehane et al., ) are also used in an engagement that requires participation of various stakeholder approach (goodman and thompson, ) . by , some of these tools had been adopted at community level, which resulted in significant reduction in the number of reported sleeping sickness and animal trypanosomiasis cases in uganda (waiswa and wangoola, ) . however various areas in uganda have been recorded as having different levels of t.brucei sl infections among cattle (unpublished survey by university of edinburgh and coctu, ), with some being potentially human infective. also, rapid changes in human behaviour, resource utilization, and other extrinsic environmental factors continue to threaten the current distribution of several endemic and historically neglected zoonoses in many developing regions worldwide , with examples of some circulating within relatively localized geographical areas for some time. therefore, the persistence of t.brucei sl infection among cattle and continued registration of sleeping sickness in uganda despite the effort by the stamp out sleeping sickness (sos) that involved treatment of the cattle reservoir since (kabasa, ; waiswa and rannalette, ; waiswa and kabasa, ; hamill et al., ) has demanded in-depth examination of the engagements by different stakeholders. the rapid impact and making a difference projects of tackling infections to benefit africa (tiba) uganda interventions offered opportunity of capturing experiences of the multi-stakeholder engagements. the one health model platform in the name of utcc, that was put in place in to handle all issues of tsetse and trypanosomiasis control in uganda provided a unique opportunity to the investigation. this manuscript captures observations and notes recorded as different stakeholders came together to implement tiba projects in uganda. stakeholder analysis was undertaken based on the identified tasks that needed to be accomplished in relation to the uganda rapid impact (ri) tackling infections to benefit africa (tiba) one-health project. elimination of zoonotic sleeping sickness needed expertise in handling the ethical, technical, political and social aspects of the target communities affected by the zoonotic sleeping sickness in the endemic focus of northern uganda. the target area was purposively chosen and covered three districts of lira, alebtong and kole that had been persistently experiencing sleeping sickness outbreaks and yet were part of the stamp out sleeping sickness than began in (waiswa and kabasa, ; waiswa and rannalette, ) . the utcc (multi-stakeholder institution with veterinary, medical, agriculture, environment, wildlife, lands and political science as key disciplines), vector control division of ministry of health (with medical specialist and host of manager of the uganda national sleeping sickness control program), leaders in district and sub-counties (technical; veterinary, medical, entomology, social work disciplines and politicians) plus community were purposively selected for engagement. all projects under tiba-uganda were submitted to the uganda national council for science and technology through the vector control division ethical committee. the committee received, evaluated the tiba project that was eventually given clearance (ref: h ) by the uganda national council for science and technology. . . stakeholder engagements . . . uganda trypanosomiasis control council (utcc) stakeholders to engage are well defined in the law (utcc act, , cap http://coctu.go.ug/utcc_act) that put in place the uganda trypnaosomiasis control council (utcc) and its secretariat, coordinating office for control of trypanosomiasis in uganda (coctu) that handles daily management and administration of the utcc as an institution. the utcc multi-stakeholder composition provided a perfect opportunity for discussions related to the approach of tiba projects in uganda at two of their statutory meetings in . the chairperson of the utcc scheduled the meetings on agreed dates with members before invitation letters were sent. policy implications of introducing new tools in surveillance and handling suspect cases especially humans found positive for trypanosome dna with these tools formed the major issues during the discussions. the usefulness of pyrethroid based acaricide in controlling the vector for trypanosomiasis was also discussed in line with the one health approach that needed to be sensitive to the tick resistance threat to the pyrethroid based acaricides in uganda. for all the target areas, letters about the tiba project were written to the chief administrative officers (caos) of alebtong, kole and lira districts with a request for a meeting with the technical staff (veterinary, medical, entomology, social workers) plus political leaders. telephone conversations were also held to reconfirm or agree on the suitable dates for the meetings. at every district meeting, discussions on dates for the community entry meetings were made and the technical staff took the responsibility of mobilisation via telephone and visitation to the different village chairpersons. the village chairpersons took the responsibility of informing and inviting the community to the meetings. community entry meetings were held to introduce the project and seek permission to start work that involved seeking consent of participants. this manuscript has captured experiences and engagements from alebtong, kole and lira districts ( fig. ) as these were the sites for the implementation of the rapid impact project that was undertaken for months starting december . meetings involving village and opinion leaders plus residents were held in each village to let them know about the project, their roles and the outcome anticipated from the interventions. after discussions with the village gate keepers (political and opinion leaders) and getting their permission, a day was set aside to hold the community meeting and consent engagements. the local government technical staff and leaders plus the tiba-uganda team explained the approach and answered any questions that arose. terms of reference for the different stakeholders and modalities of engagement were outlined and agreed on before any start of activities. all meetings were also used to verify the estimate of the human and livestock population in the villages since movement and migrations could affect numbers. cattle were targeted in the study as previous survey results indicated high prevalence of t. brucei sl. (coctu records unpublished) with evidence of the human infective t.b. rhodesiense among the recorded infections. for this investigation, the aim was to screen, treat and spray cattle kept within and around the selected villages based on an estimate of about cattle within and immediate neighbourhood (as per verbal information received early in from the respective district veterinary officers of kole, lira and alebtong districts). this was determined using the following formula by daniel ( ) n where: n = required sample size. z = z statistic for a level of confidence p = expected prevalence d = desired absolute precision using a known average prevalence of % recorded during the survey conducted by welburn & waiswa (coctu records, unpublished) and a precision of % at % ci; p = . , d = . and z statistic as . . therefore; a minimum sample size of approximately cattle was needed for the study to determine the exact prevalence of african animal trypanosomiasis (aat) and stability of trypanosomes in cattle in the villages. these samples were proportionally allocated to each village and a minimum of / = . or cattle were needed from each of the villages. however, since all owners of domestic animals in the village were mobilized, a target of - cattle per village was set as this could additionally give more elaborate information on the status of trypanosomiasis in each village. after consent of the owners or their representatives, cattle were randomly selected and bled to get blood samples. the recurrent ear vein was pricked using a lancet, blood drawn using two hematocrit tubes and immediately spotted on fta cards. the fta cards with blood spots were air dried and thereafter stored under room temperature as they awaited future analysis for presence of trypanosome dna using polymerase chain reaction (pcr). the blood screening test would give the prevalence of trypanosomiasis in general and enable estimation of the potentially human infective (t.brucei rhodesiense). since cattle in the study area had earlier been reported to carry t.brucei rhodesiense in all the target villages, diminazene aceturate was used to treat all animal kept in the study villages. similarly, all animals presented during the investigation were sprayed with deltamethrin insecticide/acaricide (vectocid® ceva sante animale, libourne, france) to promote live bait approach to control the tsetse vector as advocated by the stamp out sleeping sickness consortium since (kabasa, ; waiswa and rannalette, ; waiswa and kabasa, ) . live bait has overtime been recorded as a more community friendly and sustainable approach to controlling sleeping sickness (waiswa and wangoola, ) . at the same time, livestock farmers were encouraged to spray their animals monthly to kill the tsetse vector while getting the benefits of tick control since this was the theory of change that was expected in the community to help reduce the tsetse fly density in the area, subsequently reducing any possible transmission of animal and human trypanosomiasis. samples size determination for evaluating factors related to the human subjects was calculated using yamane ( ) formula as given below let n be the population size. e denotes margin of error. according to ubos census report ( ) area specific profiles • kole district has a population of , • alebtong district has a population of , • lira district has a population of , all this makes a total population of , . n is , . e is . ( %) n ¼ þ Ã : n= . - as the sample size. therefore, a minimum of subjects were needed to be interviewed and briefed about the study to enable them give their consent to participate. however, all residents in the target high risk villages in the three districts (kole, alebtong and lira) were mobilized to attend the screening and each was given an opportunity to voluntarily consent to the screening and blood sampling. experts in social work and community development were engaged to explain and enhance understanding, acceptability and participation in the project. the head of the sleeping sickness control program in uganda set up a team to work with staff at coctu, colleagues from the university of edinburgh and local government. a total of people were targeted to be examined for evidence of clinical signs for t.brucei rhodesiense human african trypanosomiasis (rhat) in all the three districts. in each of the villages, at least individuals were selected randomly from the those that accepted to come for the screening and their blood taken and screened for trypanosomiasis using microscopic examination. after examination by microscopy, blood was also spotted on fta cards and stored awaiting further molecular analysis for evidence of trypanosome dna. health and laboratory workers in the government health facilities were trained to build their capacity in screening and treatment for zoonotic sleeping sickness. there after they participated in active surveillance for sleeping sickness. in all places affected with zoonotic sleeping sickness, there is routine case detection done through regular active and passive screening of populations, treatment of positive cases and community mobilisation and sensitization. during the rapid impact tiba uganda project, staff in laboratories in the approved treatment centres were trained by a team from the sleeping sickness control program (ministry of health, uganda) to increase their sleeping sickness suspicion index. capacity building was also undertaken in laboratory technical skills and thereafter staff were provided with supplies to undertake the screenings as this particular stakeholder is very key and must be well equipped to be able to confirm presence of infection in communities during sleeping sickness outbreaks in the focus areas. the studies were reviewed, approved and registered with reference numbers (ref: hs ) and the process from first submission to approval took days. the various engagements necessitated a committee to oversee implementation of activities. its composition had to reflect the desires of a one-health approach in line with the utcc act, . the composition of the implementation committee is given in table . the committee sat every months to review progress and guide the implementation. additionally, the technical team involving veterinary/animal production staff, animal resource key persons (ark) (waiswa and wangoola, ), district veterinary/health technical staff, utcc/coctu staff, makerere university and university of edinburgh were in charge of the implementation and routinely met to review the standard operating procedures. tiba uganda project components fell within the constitutional mandate of the utcc and this made it easy to implement the one health approach under this platform. after endorsement of the project, utcc directed its technical committee, that was also established under the act of , to oversee and participate monitoring and evaluation of activities during tiba project implementation in addition to guiding the actors and help achievement of the envisaged theory of change. utcc has nine key stakeholder ministries that are represented by one officer not below the rank of undersecretary, appointed by each of the following the stakeholder ministries: (i) the ministry responsible for animal health. plus, three other members appointed by the minister (ministry of agriculture animal industry and fisheries) from the wider public. . . . . key issues captured that were considered critical. utcc provided a perfect opportunity for quick handling of any outcomes from the study that needed urgent policy guidance and was routinely provided with information papers on the progress of tiba uganda projects. a policy brief was provided at the end of the rapid impact project and it mainly focused on three critical issues: • some ten human samples gave signals for trypanosome dna after testing the blood with pcr. these samples have been sent for further characterisation to establish presence or absence of t. brucei rhodesiense (tbr) or t. brucei gambiense (tbg). • people whose samples had signals of tbr or tbg were reported as suspects to the manager of the sleeping sickness control program in uganda for follow up, confirmation of infection or more health/scientific evaluations. • use of synthetic pyrethroid based insecticides/acaricides in the promotion of live bait as a valuable tool to reduce transmission of zoonotic sleeping had to continue as this would enable continued contribution of livestock owners to the sleeping sickness control activities since presence of trypanosome dna in some human samples was of big concern. local governments leadership are the research gate keepers at the district and lower local government levels. they played key roles in community mobilisation and acceptance of the study. similarly, they supervised the technical teams and keenly followed up the approach during implementation of activities. the composition and roles of local government leaders is detailed in table . since the rapid impact tiba uganda project involved a 'one health approach' on studies related to zoonotic sleeping sickness, the district medical and veterinary officers took technical lead in each district. • control of the tsetse vector, passive surveillance of sleeping sickness, diagnosis and treatment of the animal disease are key aspects that need support of various stakeholders as they are pillars for sustaining good practices. however, the less sensitive clinical signs and microscopy are the major tools available for diagnosis in all the target three districts. • awareness and community guidance based on risks identified is a key role for the technical officers in local governments. therefore, they need better tools to enable accurate and timely information for dissemination community meetings were organised for all the selected villages and explanation on roles, interventions and any benefits were done in each of the target areas. dates and venues for the animal and human screening plus sampling were discussed and set. in total, community entry meetings ( for livestock owners and for human) were held and the number per district is outlined in table . all communities welcomed the investigations and expressed willingness to participate. however, some stakeholders at this level were greatly concerned with delays related to quick feedback and immediate benefits. this has been highlighted as one of the major/key issues in table . livestock owners took great interest in the study/interventions and information leaked to the neighbouring villages who brought their animals for screening as well. the numbers from outside the study villages formed the majority ( / = . %) of cattle brought to the agreed sites (see table ). this was encouraging as it indicated that these stakeholders had taken interest in the research and shared the potential benefits with the neighbours. animals from outside the target villages were not bled or treated with diminazene aceturate but were all sprayed with deltamethrin as a promotion of use of live bait for the control of the tsetse vector. it was also recorded as a finding by the research team that: • the private sector led supply chain for deltamethrin based acaricide/insecticide that can be used for spray is not consistent and yet this is needed to sustainably enable farmers contribute to the control of the tsetse vectors. the livestock owners requested for interim government intervention . . human study: screening for signs of sleeping sickness, taking blood samples and examination using parasitological techniques as sleeping sickness control moves towards the elimination phase in uganda, explanations to the community and justification for them to turn up for screening in the absence of reported cases is needed. interestingly, the 'one-health' approach adopted by the rapid impact uganda tiba project attracted a lot of community interest since earlier investigations had indicated presence of potentially human infective t.b. rhodesiense among cattle kept in the selected villages, thus highlighting the potential risk of transmission of the disease to the human population in these areas. table gives the number of individuals screened per village. • the community quickly understood the veterinary and medical team explanation. the turn up per site was good and sometimes beyond expectation, including allowing children in schools a few hours break to participate in the exercise, adding school head teachers and staff plus management committees as key stakeholders. • sharing the right information with the community is critical in stimulating the appropriate action. • there were no sleeping sickness cases detected using microscopy. a total blood samples were submitted to laboratories for trypanosome dna screening. of these samples had positive signals for trypanosome dna and this matter was reported to the utcc in a policy brief for guidance. multi-stakeholder engagement in uganda to control sleeping sickness is an approach that started during the - epidemic in the busoga region where , male and female patients were detected with the acute zoonotic sleeping sickness (abaru, ) . establishment of an inter-ministerial committee to help handle the sleeping sickness epidemic was among the key strategies used to control the disease. this later resulted into the formation of the coordinating office for control of trypanosomiasis in uganda (coctu records, , unpublished) . coctu was subsequently institutionalised to become the secretariat of the uganda trypanosomiasis control council (utcc) through an act of parliament (utcc act, , cap ). in line with the earlier approach, current zoonotic sleeping sickness elimination agenda must be participatory and needs a multi-stakeholder arrangement given the wide range of animal reservoir host that live in different ecological settings. according to vandersmissen and welburn ( ) , working together in a one health movement, which addresses risks, including zoonoses, at the humananimal-environment interface requires the development of innovative partnerships at the political, institutional and technical levels and it is a sustainable and rational option although it demands long-term financial investment. alebtong lira kole total table number of households, people and blood samples taken for parasitology examination. the utcc institutional arrangement has nine stakeholder ministries represented at the council by people at the level of under secretary, director or commissioner heading the department responsible for control of trypanosomiasis (http://www.coctu.go.ug/ about_coctu.html). these join three appointed eminent citizens to constitute the utcc that guides the country on issues of trypanosomiasis control (http://www.coctu.go.ug/about_coctu.html). the utcc act similarly provides for the technical committee (tc) whose composition is made up of technical officers responsible for issues related to tsetse and trypanosomiasis in the stakeholder ministries. after more than years of its establishment, the multi-stakeholder approach and information sharing has brought uganda towards elimination of sleeping sickness (waiswa and wangoola, ) . as earlier stated by some scholars, projections of growth in the demand for livestock production and consumption in asia and africa also call for effective one health responses (vandersmissen and welburn, ) . the coordinating office for trypanosomiasis control in uganda is one example of consolidating the one health approach in the global network (vandersmissen and welburn, ; and highlights the importance of interfacing with key policy issues in preventing the emergence and reemergence of zoonotic disease using hat in uganda as an example. the coctu approach has turned rhetoric into reality and action in integrating global health governance with national priorities that enables putting theory into practice of integrated health approaches (okello et al., ; . the utcc model as adopted and institutionalised by uganda in provides an effective platform to give immediate response as over time, for the past years, there has been evidence of the socio-economic value that the one health approach has led to the reduction of sleeping sickness in the human population (franco et al., ) and areas that were not able to keep high grade cattle like south eastern uganda can now benefit from them if they adopt appropriate recommendations on cost benefit analysis of the different control options (shaw et al., (shaw et al., , . relatedly, research around sos and coctu onehealth approach that was supported by iconz (okello et al., a (okello et al., , b (okello et al., , c raised the profile of neglected zoonotic diseases through three complementary european commission-funded projects that aimed to streamline research, build capacity and advocate for their control. this research also showed that only % of cattle need to be treated with rap to cost effectively control hat (muhanguzi et al., b) and that this treatment has a large impact on household income okello et al., a okello et al., , b okello et al., , c . the long-term success of sos is the fact that activities are now embedded within coctu policy and practice. treatments have been sustained by farmers in hat at risk zones of uganda as evidenced by the high turn up of cattle owners and their livestock from within and beyond the study villages. during this investigation/study, more cattle were brought from neighbouring none target villages ( / = . %) and this interest is one of the reasons why this stakeholder has significantly contributed to rhat control in uganda since over million cattle are now treated annually (waiswa and wangoola, ) . with the rise of covod- , it is more important than ever to deliver one-health in practice to address emerging zoonoses (mazet et al., ) and it is very crucial to develop one health diagnostic facilities that can deliver rapid results to the populations that need them for rapid interventions to take place and to avoid pandemic panic and anxiety in the developing countries as is seen now (iceland et al., ) . tiba projects in uganda have emphasised involvement of leadership especially at national and local governments levels as their support, good governance and effective policies and networks are needed as building blocks for the sustainability of the one health approach adopted by uganda since the beginning of the to s sleeping sickness outbreak. the high turnup for the human and animal interventions plus active involvement by all stakeholders was as planned. engagements were even easier when the risk was explained as feedback of earlier findings in by coctu and the university of edinburgh that partnered and designed a survey that took samples from cattle in clusters (villages) across uganda and completed pcr analysis to determine the overall prevalence of t. brucei s.l. and t.b. rhodesiense. that study provided unprecedented insights into the spatial distribution of the t. brucei s.l. and t. b. rhodesiense human infective parasites across the full geographic extent of the most important active zoonotic hat focus in east africa (coctu records, unpublished) . this data set was shared with the different stakeholders at the inception and was a good tool used during the engagements and mobilisation of stakeholders to participate in the rapid impact (ri) tackling infections to benefit africa (tiba) uganda project. consequently, this addressed the key issue of delayed feedback and the turn up of human and animals for the studies was as planned and the desired number of animals and human were screened in each of the villages. however, definite answers on timing of feedback are still needed as the time between taking blood samples and getting results after analysis with the more sensitive molecular tools that target detection of trypanosome dna is still the unacceptable many months especially in the face of potential disease outbreak. this became very urgent in the human screening where the microscopic based parasitological screening gave negative results for all people screened and yet the team could not give a definite answer as to whether the community can be declared free from sleeping sickness. like for covid- we need rapid point of care diagnostics for use in the community to feed into a coctu reference centre. the diagnostics need to come to the community as the stakeholders have highlighted the importance of having these tools domesticated in uganda for quick public access and feedback. for trypanosomiasis control, engagement of community-based networks during activities as was for stamp out sleeping sickness (waiswa and rannalette, ; waiswa and kabasa, ) where students and spray persons were mentored and continue to be used as a sustainable approach (waiswa and wangoola, ) seems necessary. mentoring these networks in interventions and using them for surveillance is a major focus for the proposed setup of the uganda tsetse and trypanosomiasis resource centre (uttrc, unpublished) that has already received support from the utcc to help address the quick feedback and linkage to the community. however, the real solution to the challenge is for the stakeholders to access tools that can be used in the field and generate results on site and be able to share them quickly with stakeholders. for one health to be realised, and with the emergence of zoonotic infections that can rapidly spill into large populations, rapid diagnostics that share a common platform are essential to enable serve both rural and growing city populations. what various actors have learned from old diseases, such as sleeping sickness and new diseases such as covid- is that timely diagnosis is key and laboratories need to be established for notifiable zoonotic diseases in-country like for uganda to enable routine screening for human african trypanosomiasis (hat). more especially now that hat cases are declining, it has never been more important to find cases quickly to continue the path to elimination. the tiba projects in uganda are putting a lot of effort in that direction, with need for different stakeholders both local and international to come together with the needed support be it political, technical, financial or others to address the quick feedback issue that is currently of major concern. for the animal interventions to reduce on the animal reservoir and promotion of live bait to suppress the tsetse fly vector population using the approach of restricted application to tap into the less is more (torr et al., ) , the community had concern on the inconsistent supply of the chemicals by the private sector, an issue that had already been noted in earlier studies (waiswa and wangoola, ) . strengthening of the supply chain of chemicals that benefit both tsetse and tick control should be undertaken if communities are to actively engage with the theory of change that is desired to sustain interventions and eliminate sleeping sickness. relatedly, affirmative action by utcc is needed during this period when uganda is faced with challenges related to tick resistance to some of the products on the market. multi-stakeholder engagements similar to the utcc approach in uganda are very efficient as demonstrated on the way trypanosomiasis control in uganda has been handled. however, like any other team, after winning several engagements especially in controlling sleeping sickness in uganda during different outbreaks in the last three decades, the elimination point comes with issues on the captain to lift the trophy. this study has shown that every stakeholder needs to play their role and take interest plus allowing new stakeholders to cover the spaces that must be bridged to enable sleeping sickness elimination. as people may behave differently and impact on the control of a disease like sleeping sickness, future studies will need to look at the attitude, perception and behaviour of different stakeholders as factors that affect quick achievement of elimination of sleeping sickness in uganda. the utcc secretariat coctu has been in the best position to observe different key stakeholders and each one of them has been a major factor in the success registered to date and all deserve the space to place their hands on the trophy for winning the battle targeted at eliminating sleeping sickness from uganda. none. sleeping sickness in busoga tsetse fly (g. f. forcipes) distribution in the lake victoria basin of uganda biostatistics: a foundation for analysis in the health sciences monitoring the elimination of human african trypanosomiasis: update to the science of stakeholder engagement in research: classification, implementation, and evaluation evaluating the impact of targeting livestock for the prevention of human and animal trypanosomiasis, at village level, in districts newly affected with t. b. rhodesiense in uganda pandemic panic and anxiety in developing countries. embracing one health offers practical strategies in management of covid- for africa public-private partnership works to stamp out sleeping sickness in uganda tsetse control and the elimination of gambian sleeping sickness histopathological chnages in some reproductive and endocrine organs of trypanosoma brucei infected west african dwarf goat does a "one health" approach to address emerging zoonoses: the hali project in tanzania the burden and spatial distribution of bovine african trypanosomes in small holder crop-livestock production systems in tororo district improvements on restricted insecticide application protocol for control of human and animal african trypanosomiasis in eastern uganda cost analysis of options for management of african animal trypanosomiasis using interventions targeted at cattle in tororo district; south-eastern uganda socioeconomics of animal and human trypanosomiasis in uganda the importance of veterinary policy in preventing the emergence and re-emergence of zoonotic disease: examining the case of human african trypanosomiasis in uganda. front. public health , one health and the neglected zoonoses: turning rhetoric into reality crossing institutional boundaries: mapping the policy process for the control of neglected zoonotic diseases in sub-saharan africa. health policy plan raising the profile of neglected zoonotic diseases: three complementary european commission-funded projects to streamline research, build capacity and advocate for control contribution of draft cattle to rural livelihoods in a district of south eastern uganda endemic for bovine parasitic diseases: an economic evaluation one health into action: integrating global health governance with national priorities in a globalized world sleeping sickness in uganda: a thin line between two fatal diseases cattle movements and trypanosomes: restocking efforts and the spread of rhodesian sleeping sickness in post-conflict uganda estimating the costs of tsetse control options : an example for uganda ଝ. prevent intervening against bovine trypanosomiasis in eastern africa: mapping the costs and benefit. programme against african trypanosomiasis. food and agriculture organisation of the united nations the atlas of human african trypanosomiasis: a contribution to global mapping of neglected tropical diseases less is more: restricted application of insecticide to cattle to iprove the cost and efficacy of tsetse control current initiatives in one health: consolidating the one health global network porcine trypanosomiasis in southeastern uganda: prevalence and assessment of therapeutic effectiveness experiences with an in-training community service model in the control of zoonotic sleeping sickness in uganda entrepreneurship initiatives in the control of sleeping sickness: experiences of the stamp out sleeping sickness in uganda sustaining efforts of controlling zoonotic sleeping sickness in uganda using trypanocidal treatment and spray of cattle with deltamethrin. vector borne zoo domestic animals as reservoirs for sleeping sickness in three endemic foci in south-eastern uganda glosssina fuscipes fuscipes in the trypanosomiasis endemic areas of south eastern uganda: apparent density, trypanosome infection rates and host feeding preferences one health: the theory and practice of integrated health approaches identification of human infective trypanosomes in animal reservoir of sleeping sickness in uganda by means of serum-resistance-associated (sra) gene the neglected zoonoses-the case for integrated control and advocacy statistics, an introductory analysis we are grateful to the scholarly contributions made by the different stakeholders during the gathering of information used to compile this manuscript. this research was commissioned by the national institute for health research (nihr) global health research programme ( / / ) using uk aid from the uk government. the views expressed in this publication are those of the authors and not necessarily those of the nihr or the department of health and social care. key: cord- - rcbpg authors: vindegaard, nina; eriksen benros, michael title: covid- pandemic and mental health consequences: systematic review of the current evidence date: - - journal: brain behav immun doi: . /j.bbi. . . sha: doc_id: cord_uid: rcbpg background: during the covid- pandemic general medical complications have received the most attention, whereas only few studies address the potential direct effect on mental health of sars-cov- and the neurotropic potential. furthermore, the indirect effects of the pandemic on general mental health are of increasing concern, particularly since the sars-cov- epidemic ( - ) was associated with psychiatric complications. methods: we systematically searched the database pubmed including studies measuring psychiatric symptoms or morbidities associated with covid- among infected patients and among none infected groups the latter divided in psychiatric patients, health care workers and non-health care workers. results: a total of studies were included. out of these, only two studies evaluated patients with confirmed covid- infection, whereas evaluated the indirect effect of the pandemic ( on patients with preexisting psychiatric disorders, on medical health care workers, and on the general public). of the studies were case-control studies/compared to norm, while of the studies had no control groups. the two studies investigating covid- patients found a high level of post-traumatic stress symptoms (ptss) ( . %) and significantly higher level of depressive symptoms (p= . ). patients with preexisting psychiatric disorders reported worsening of psychiatric symptoms. studies investigating health care workers found increased depression/depressive symptoms, anxiety, psychological distress and poor sleep quality. studies of the general public revealed lower psychological well-being and higher scores of anxiety and depression compared to before covid- , while no difference when comparing these symptoms in the initial phase of the outbreak to four weeks later. a variety of factors were associated with higher risk of psychiatric symptoms and/or low psychological well-being including female gender, poor-self-related health and relatives with covid- . conclusion: research evaluating the direct neuropsychiatric consequences and the indirect effects on mental health is highly needed to improve treatment, mental health care planning and for preventive measures during potential subsequent pandemics. the world is currently facing the covid- pandemic with a novel corona virus, sars-cov- , initially observed in wuhan, hubei, china in the end of . the reported symptoms of covid- are primarily respiratory with acute respiratory distress syndrome ultimately leading to dead in the most severe cases. however, covid- have also been shown to affect other organs, including the brain, and recently reports on neurological symptoms due to covid- infection are emerging. [ ] [ ] [ ] [ ] [ ] there are indications of neurotropic properties of sars-cov- ; however, yet little appears to be known about the exact mechanisms on how it affects brain functioning. covid- is a betacoronavirus and knowledge from other outbreaks with viruses from the corona family, like sars-cov- , can now be useful, despite differences between the viruses. psychiatric symptoms including posttraumatic stress symptoms (ptss)/posttraumatic stress disorder (ptsd), anxiety and depression among patients with sars-cov- have been reported during the sars epidemic , and after month, , year and months and longer. , also psychiatric symptoms of ptsd, depression and anxiety have been described among health care workers during and months , and years after the sars epidemic as well as among the general public during and after the epidemic. , we aimed to systematically review the literature in order to provide an overview of the psychiatric complications to covid- infection (direct effect) and how covid- are currently affecting mental health among psychiatric patients and general public (indirect effect) alongside with factors altering the risk of psychiatric symptoms in both groups. the following studies were included: . studies reporting psychiatric symptoms/morbidity of patients with current or prior sars-cov- infection. . studies reporting psychiatric symptoms/morbidity of psychiatric patients during the covid- pandemic . studies measuring psychiatric symptoms/morbidity/mental health during the covid- in uninfected/not known to be infected participants, divided in health care workers and nonhealth care workers papers with psychiatric symptoms/morbidity in the elderly (including dementia), children/adolescents (including attention deficit hyperactivity disorder and autism), substance abuse and somatic disease as primary outcome were not included. studies were identified by searching the database pubmed. only papers published in english were included. the publication period was unlimited. the search was performed at the may , . (psychiatry or "mental health disorders" or "mental health") and (covid- or sars-cov- ) one investigator (nv) screened titles and abstracts to exclude obviously irrelevant articles and further examined the remaining full text reports to determine compliance with inclusion criteria. one investigator (nv) screened relevant reviews for additional trials and nv examined full text reports of these additional records. the study selection process is illustrated in supplementary figure . the data extraction was carried out by one investigator (nv) but repeated. we sought for the following information in the full-text records: journal information (authors and year of publication), study design and instruments, number of participants, demographics (sex, age, employment (health-care/non-health care)), psychiatric symptoms/morbidity and infectious status (currently infected, previously infected, no history of infection). the initial search resulted in hits and additional papers were identified from the references in reviews from the search. of these were included for full text review leading to inclusion of papers (table and ). out of these, two papers evaluated patients with confirmed covid- infection, and the indirect effect of the pandemic ( on patients with preexisting psychiatric disorders, on medical health care workers and on the general public). of the studies were case-control studies or compared to norms, while of the studies had no control groups. only two papers , reported on psychiatric symptoms among patients with covid- . the first study showed that ptss were present among . % out of hospitalized but stabile patients. the second study showed that the prevalence of depression ( . %) was elevated (p= . ) among patients newly recovered from covid- compared to participants in quarantine ( . %), while no difference in anxiety level was found (p= . ). one study evaluated symptoms of patients with eating disorders during the pandemic and found . % to report worsening in their eating disorder symptomatology and . % to report additional anxiety symptoms, while another study reported that . % of patients with preexisting psychiatric disorders reported worsening of their symptoms, but did not report the preexisting diagnoses. among health care workers depression/depressive symptoms (five papers) and anxiety (seven papers) were increased (compared to norms, , administrative staff, , non-frontline workers or the pandemic was under control, or to experienced staff ), while two papers found no difference (compared to the general public and non-frontline workers ). poor sleep quality was found among health care workers compared to norms. no difference in ptss was observed, and vicarious traumatization scale scores were actually less elevated (p < . ) when comparing to the general public. higher levels of obsessive-compulsive disorder symptoms were reported in medical health workers compared to non-medical staff. regarding the general public one paper revealed lower psychological well-being (who- ) compared to before covid- , and one study revealed increased use of words as emotional indicators of anxiety and depression (on weibo), when compared to prior to the outbreak. furthermore a study of parents of children hospitalized during the epidemic period had significant higher scores of anxiety, depression and dream anxiety compared to parents of children hospitalized in the non-epidemic period (all p < . ). however, a study found no significant difference in anxiety, depression or stress symptoms when comparing scores measured in a period with increase in number of confirmed cases to a period with increase in number of recovered cases (p> . ); however, only of the , cases were followed up. one study found no significant difference in any items between workers/technical staff (n= ) and management/executive staff (n= ) (all p > . ), and one study found no difference between being in quarantine (n = ) or not (n = ). the following factors were reported to be associated with risk of psychiatric symptoms among health care workers and the general public: the following sociodemographic factors were associated with depression and/or anxiety: living alone, lower educational level, , but also higher, student status, not having a child, or having ≥ children, living in urban areas (hubei), , but also in rural areas, , female gender , , , , was reported frequently, but was not consistent, , while reports on age as a risk factor were inconsistent. , , current medical disease (including psychiatric disorders and substance abuse), , , and a past medical history (including psychiatric history and substance abuse) , , , were associated with/increased the risk of depression and/or anxiety. poor-self rated health, , , poor sleep quality, higher perceived stress load, , previous distressful lifeevents, lack of psychological preparedness, perceived self-efficacy to help the patients, lacking knowledge of the pandemic, , not taking precautionary measures, and impacts on daily life. furthermore relatives/friends/acquaintance suspected of/acquired covid- , , , , , , less family support, low social capital (during isolation), unsteady family income, and higher social media exposure were associated with/increased the risk of depression and/or anxiety. working in frontline compared to second line, , secondary hospital compared to tertiary, title intermediate compared to junior, and > years of working were associated with/increased the risk of depression and/or anxiety. the risk of ptss were positively associated with female gender, , living in hubei province, , lower education and subjective sleep quality, , but not with age. a variety of factors was associated with higher psychological distress/affected general mental health a total of studies were included. only two studies had investigated mental health issues in covid- patients finding a high level of ptss ( . %) and significantly higher level of depressive symptoms ( . %). two studies reported symptoms on psychiatric patients, which appeared to have worsening in psychiatric symptomatology. among health care workers depression/depressive symptoms, anxiety, psychological distress and poor sleep quality were increased. regarding the general public one paper revealed lower psychological well-being (who- ) compared to before covid- , while a longitudinal study found no difference in anxiety, depression or stress symptoms early in the pandemic compared to after four weeks. a variety of factors were associated with higher risk of psychiatric symptoms and/or low psychological well-being of the general public including female gender, front-line health care workers, and poor self-rated health. it is well known that surviving critical illness can induce ptss and in line with this, levels of ptss were found to be very high ( . %) among patients during hospital admission with covid- infection, which is far higher than found in the general public ( %). the risk of depression was also found to be higher among patients with covid- . it is generally established that infections are associated with a higher risk of mood disorders, and there seems to be a higher risk after severe infections. this is in line with the findings from the sars-cov- epidemic revealing depressive symptoms among patients during the infection. , this higher risk could be due to the corona-virus affecting the brain directly or indirectly by inducing a massive cytokine response affecting the brain. of notice is that among patients with prior sars-cov- infection a higher rate of depression/depressive symptoms was observed after month , and year. the sars-cov- spread to more than countries affecting more than people and died from the infection, while covid- has already spread to countries affecting more than . . people and we must expect a huge after-wave of patients surviving covid- suffering from depression. regarding anxiety the evidence is still scarce, and this should be investigated further since anxiety symptoms were reported during and following , sars-cov- . furthermore sars-cov- has been shown to induce affective psychosis at least during the acute phase of the illness, but we found no papers addressing this matter yet for sars-cov- . severe infections and inflammatory processes can cause delirium with a broad variety of psychiatric symptoms and encephalopathy, which has been reported among sars-cov- positive patients, but the evidence is still scarce and the neurotropic potential of sars-cov- needs to be elucidated. worsening of the psychiatric symptoms among some patients with pre-existing psychiatric disorders, was reported, , and two case studies report on the covid- pandemic being a part of the psychotic content of two non-infected patients admitted to the psychiatric word. , however, our systematic review reveals that knowledge on the covid- impact on patients with preexisting psychiatric disorders is very scarce, and the knowledge of impact from earlier pandemics/epidemics on this group is also very limited. from previous studies of the sars cov- epidemic it is known that health care workers are at risk of anxiety and depressive symptoms, which the current studies indicate also is the case of covid- . health care workers should be regarded as a highly exposed group with a higher risk of psychiatric symptoms during the covid- pandemic, and risk factors are female gender and frontline workers among others. currently data is scarce, but indicates that mental health is affected in the general public, when compared to before the outbreak; however, the only longitudinal study (following participants up) found no difference in depression, anxiety and stress in the period with many new cases compared to the period with many recovering. this is interesting, since it is known from the prior sars-cov- epidemic that those in the general public, who were impacted of the epidemic (e.g. by quarantine) had psychiatric symptoms months after control of the epidemic, and this could indicate that long lasting symptoms after sars-cov- also must be expected. many risk factors (especially of depressive and anxiety symptoms) has been reported, but most of them are already well-known risk factors for mental health conditions (e.g. female gender, current or past medical history, and poor-self-related health ). however the pandemic is adding an aspect of quarantine and isolation that is also an established risk factor with psychological impact, like worrying about family, friends and acquaintances being infected is also a newly added dimension. due to the altered living conditions many of the identified risk factors will increase most likely leading to an increase in patients. there are indications in the literature of a neurotropic effect of sars-cov- . evidence of a variety of neurological symptoms among patients suffering from covid- is evolving, and delirium is a frequently reported symptom of sars-cov- and could be caused by a direct cns invasion. interestingly two case studies reports sars-cov- meningitis/encephalitis; , however, only one of them had a confirmed positive sars-cov- rt-pcr test on csf. ace is a functional receptor for sars-cov- and it is known that ace is expressed in neurons, which is interesting in the light of the many reports of anosmia as an early symptom of covid- , since sars-cov- has been suggested to enter the brain trough the olfactory bulb. taken together this indicates that sars-cov- could be neurotrophic entering the brain through the olfactory bulb, leading to an increase in neuropsychiatric symptoms among the patients surviving covid- . when discussing the potential effects of sars-cov- on the brain it is worth noting the reports on altered peripheral immunological alterations among covid- patients. significantly higher levels of neutrophils, but significantly lower levels of lymphocytes have been reported among severe cases compared to nonsevere, and patients with sars-cov- have been reported to have high amounts of the pro-inflammatory cytokines (il- beta, ifn-gamma, ip and mcp- ) suggesting a th response. a pro-inflammatory response has been reported among patients with mdd in both plasma and csf, and the associations between neuropsychiatric symptoms and proinflammatory response needs to be elucidated further. the strength of this review is that it was systematically conducted. the study is limited by several factors. firstly, the majority of the studies were conducted in asia (only four studies from europe and none from other continents), limiting the current generalization of the results. secondly, most of the studies were cross-sectional ( / ) and with a variety of reported outcomes, measuring of outcomes and statistical analysis was revealed. thirdly, the literature on psychiatric symptoms among patients with sars-cov- infection and among psychiatric patients were very limited. although the current evidence is scarce concerning direct effects of covid- on mental health, there are indications of increased levels of ptss and depression following the covid- infection. regarding the indirect effects of covid- on general mental health there seems to be evidence of an increase in depressive and anxiety symptoms along with negative impact on general mental health, particularly among health care workers. research evaluating the direct neuropsychiatric consequences and the indirect effects on mental health is highly needed to improve treatment, mental health care planning and for preventive measures during potential subsequent pandemics. the present study was funded by an unrestricted grant from the lundbeck foundation (grant number r - - ). clinical features of patients infected with novel coronavirus in wuhan clinical characteristics of coronavirus disease (covid- ) in china: a systematic review and meta-analysis lugte-og smagstab som primaere symptom på covid- . ugeskr possible unregistered sars-cov- 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mapping risk factors for depression across the lifespan: an umbrella review of evidence from meta-analyses and mendelian randomization studies abbreviations: pcl-c: self-reported ptsd checklist ( or items), ghq- / : / -item general health questionnaire, gad- : -item ge depression scale, sas: self-rating anxiety scale, ces-d: center for epidemiology scale for depression, psqi: pittsburgh sleep quality inde impact of event scale-revised, vts: vicarious traumatization scale, nrs: numeric rating scale on fear, hama: hamilton anxiety scale, ha self-efficacy scale, sars: stanford acute stress reaction, ssrs: social support rate scale, sf- : -item short form survey, scl- -r: health questionnaire- / / items. key: cord- -bfho w authors: figuié, muriel title: global health risks and cosmopolitisation: from emergence to interference date: - - journal: sociol health illn doi: . /j. - . . .x sha: doc_id: cord_uid: bfho w according to beck’s ‘world at risk’ theory, global risks push nations towards a cosmopolitisation of their health policy and open opportunities for a democratic turn. this article provides an empirical analysis of beck’s theory, based on the experience of vietnamese authorities from to in managing the emerging avian flu virus. it shows how vietnam’s framing of avian flu has shifted, under the pressure from international organisations and the us administration, from an epizootic and zoonotic risk (or a classic risk) to a pandemic threat (or a late modern risk). vietnam’s response was part of its overall strategy to join the world trade organization and it was limited by vietnam’s defence of its sovereignty. this strategy has been successful for vietnam but has limited the possibility of cosmopolitan and democratic transformations. the case study highlights the constructed dimension of risks of late modernity and their possible instrumentalisation: it minimises the role of a community of fear relative to a community of trade. international health organisations and western nations are exerting growing pressure on other countries to cooperate in managing health risks such as emerging diseases, as demonstrated during the recent episodes of severe acute respiratory syndrome (sars) and avian flu (scoones ). this pressure is being exerted on countries with different perceptions of risks and with different agendas (renn , taylor-gooby and zinn ) . in this article i examine how risks defined as 'global' by stakeholders in the international community push nations toward a cosmopolitisation of their risk management policies, together with the mechanisms used and the intended and unintended outcomes. i use beck's world at risk theory (beck ) to study one empirical case: vietnam's management of a recent emerging disease, the highly pathogenic avian influenza (hpai), which is associated with the avian flu virus (h n ), and popularly known as avian flu, avian influenza or bird flu. this study covers the period from to , a period of intense international activity in avian flu management. i will discuss the link between global risks and cosmopolitisation, as identified by beck. the following sections show how avian flu has been framed by international organisations and how vietnam has complied with this definition, under pressure from the us administration and international organisations such as the world health organization (who), the world organization for animal health (oie) and the food and agriculture organization (fao) . i analyse the mechanisms of this convergence and its consequences for vietnam. finally, the discussion addresses the role of country reputation, national sovereignty, community of interests, community of fear and values as driving forces for a cosmopolitisation of health policy. i conducted a comprehensive review of all the grey literature documents on avian flu issued by the vietnamese ministries of health, and agriculture and rural development, of official documents on vietnam's strategy for avian flu (known as the 'red book' and the 'green book') and regulations adopted by the vietnamese government, as well as expert reports from international and foreign organisations (fao, who, agrifood consulting international and agence franc¸aise de de´veloppement). in-depth interviews were conducted in and with key informants involved directly in vietnamese avian flu management. in total, people were interviewed, half of whom were working in public or private vietnamese organisations (and representing the ministry of agriculture and rural development [mard] , the ministry of health [moh] and the veterinary services of two provinces, as well as representatives of the private sector). the other half were stakeholders from the international community (members of the fao avian influenza team; experts in infectious diseases working for the who, members of the partnership for avian and human influenza (pahi) , representatives of foreign non-governmental organisations (ngos) active on the topic and one member of the leadership of an international hospital). interviewees were asked to relate the role of the different stakeholders in the avian flu management over time and the major points of debates and controversies. most interviews were conducted in english, with a few in vietnamese through a translator. interviewees were guaranteed anonymity. some people have been interviewed twice or even three times. the interviews were recorded wherever possible and transcribed for further in-depth analysis. additional information was collected from the websites of the fao, oie and who on avian flu and sars, on the 'one world one health' strategic framework adopted by these organisations, on the international health regulation of the who, and on the terrestrial animal health code of oie. the theory of risk society (beck ) describes the transition of societies from first modernity (or industrial societies) to second modernity (or late modernity). second modernity is characterised by global risks or, more exactly, global anticipated uncertainties. for beck ( ) global risks (or late modern risks) are both real and constructed. on the realist side, global risks are manmade, produced by industrial modernisation and linked to globalisation. they are incalculable, since their destructive potential to health and the environment may have long-term and large-scale effects. on the constructivist side, global risks are produced by the ambition of late modern societies to anticipate and control potential catastrophes. as anticipated catastrophes, global risks take the form of contested knowledge: 'their reality can be dramatised or minimised, transformed or simply denied according to the norms which decide what is known and what is not' (beck : ) . consequently, late modern societies are confronted with a diversity of viewpoints and values from which risks can be evaluated. this situation creates the potential for new forms of risk governance involving a wide network of stakeholders and creating opportunities for an 'involuntary democratization' (beck : ) . beck's theory has been widely criticised for its eurocentrism, even by beck himself ( beck and grande , dingwall , mythen . in response, beck and his associates have developed the world at risk theory (beck , beck and grande ) . they have introduced the concept of cosmopolitan modernities in order to take into account the varieties of modernity according to specific national cultures and histories and their global interdependencies. one of the main issues addressed by the world at risk theory is: how do countries on different paths towards modernity, and with different risk perceptions, cooperate or not, in order to confront shared global risks? this question emphasises the realist dimension of global risk, since it opposes the diversities in risk perceptions to the nature of late modern risks. beck has been criticised for the ambiguous status of risk in his theory. according to burgess ( ) , in many works inspired by this theory, risks remain given, objectified and decontextualised, despite a proclaimed constructionist approach: their scientific and politically manufactured dimensions are often neglected. for mythen ( : , quoting lash: ) , 'so far as perceptions of risk are concerned beck leans heavily towards the realist position'. this article attempts to show that the framing of a risk as a global risk (that is, according to beck's definition, as a potential threat) varies according to stakeholders and over time. it will contextualise and exemplify beck's assertion that: global risks provide a basis of legitimation for political institutions and social movements that press for more humane forms of globalisation, which does not preclude, of course, that this cosmopolitan moment can be instrumentalised for ideological purposes. (beck : - ) avian flu: a classic and a modern risk h n , the virus responsible for avian flu (more exactly, responsible for a hpai) may be framed either as a classic risk or as a risk of second modernity. experts of international organisations consider avian flu and emerging diseases in general as products of a globalised environment requiring global answers (fao et al. , oie , who b . the virus first appeared in hong kong in and then re-emerged in vietnam and china in before spreading to more than other countries over the last nine years: today more than ever the international spread of diseases or other risks threatens health, economies, and security. no country can 'go it alone' in protecting its citizens from the threats. (who b: ) and the director of the oie, dr b. vallat ( : ) declared: 'indeed, a single country failing to control animal disease outbreaks could put the entire world at risk'. is this characteristic enough to define avian influenza as a risk of second or late modernity? different authors (burgess , boudia and jas , dingwall , me´ric et al. ) have criticised beck's claim about the newness of risks of global scale and his lack of a historical perspective. but risks of second modernity are not just global risks -they are an anticipation of threat. avian flu poses a three-dimensional risk. firstly, it is an epizootic disease, that is, a disease causing high mortality in an animal population; in this case poultry raised by farmers and wild birds. secondly, it is also a zoonotic disease: it can be transmitted from poultry to humans but its impact has been limited compared to other infectious diseases ( fatalities worldwide since ). but thirdly, experts fear that the virus might mutate into a form that is transmissible from human to human, which could provoke a human influenza pandemic with high mortality. this mutation could be just a question of time: as dr nabarro, the un coordinator for avian flu declared in answering the question 'what is the probability of a pandemic?' to a journalist from the poultry diseases network, ): [w]e cannot say with any certainty at all when it would happen, where it would start, how severe it would be. so the only certainty we can share with each other is that it would happen one day. in a joint press release on january fao et al. ( ) describe avian flu as a serious threat to humanity. different stakeholders (such as farmers, consumers and policymakers), living on different paths of modernity with different risk cultures may focus on one dimension or another of avian flu: epizootic, zoonotic or pandemic. as an epizootic or zoonotic disease, h n is a classic risk. as a pandemic threat, avian flu is a risk of second modernity, according to beck's definition. and that is the way international organisations have framed it. avian flu (h n ) marks a new stage in the internationalisation and globalisation of action to control health. first, the management of this risk by international health organisations indicates 'a colonisation of the future', in the words of beck ( : ) . it marks the unprecedented ambition of the institutions in charge of managing human and animal health risks to prepare the world for a virus that still does not exist but which could emerge from a mutation of h n . secondly, the discourses produced by international organisations mark the end of a discourse that everything is under control. in a who handbook on avian flu published for journalists (who b) one can read: 'the great unknown: why there are no certain answers for the big questions' (p. ) as well as, throughout the text: 'we don't know' (p. ), 'unpredictable' (p. ), 'uncertain' (p. ). thirdly, h n and sars have opened the way for global health governance with an extended scope of intervention for international organisations and greater interference (see calain for the who strategy). new who and oie regulations encourage nations to go beyond routine measures on borders and to adopt preventive measures at the source of contamination, that is, within affected countries. member states' obligations have been extended to the declaration of any 'extraordinary public health event which constitutes a public health risk to other states through the international spread of disease, and may require a coordinated international response' (who c: ). lastly, the who and oie are now authorised to take note of any information source on disease outbreaks in addition to official notifications from national administrations. dr chan, director-general of who ( a: xv), noted: 'this reflects a new reality in a world of instant communications: the concealment of disease outbreaks is no longer a viable option for governments'. the framing of avian flu by international organisations (who, oie, fao) illustrates a high porosity between the spaces of international stakeholders involved in health issues and academic researchers on risk society. the new paradigm 'one world one health' elaborated by international organisations (fao et al. ) calls countries and actors (private, public; administration and civil society; experts of animal, human and environment health) to transcend boundaries, to progressively construct shared perceptions of health risks and to build coordinated responses to global health issues. this paradigm reflects what beck calls a community of fate and a community of responsibility. but the current results are far from 'cosmopolitan moment' (beck : ) in which nations see themselves as parts of a community of threat and fate and voluntarily contribute to global cooperation. according to beck ( : ) global risks could open up 'a moral and political space that can give rise to a culture of responsibility that transcends borders and conflicts' but this opportunity has not been seized in the case of avian flu. conversely, scoones ( ) has shown that the new global health governance is dominated by a northern perspective that ignores the structural inequalities of access to resources and exposure to risk. moreover it forces poor countries to focus on a potential catastrophe when they already lack the resources to address classic infectious diseases like meningitis or malaria (calain ) . global risks push for a globalisation of health governance. but global risks also presuppose the existence of international organisations that manufacture uncertainties through a performative discourse justifying an extended scope of intervention for themselves. did the perception and framing of avian flu by international health organisations converge in vietnam or did it reveal a clash in risk cultures? global risks being in beck's theory, a product, as well as a driving force of late modernisation, vietnam's experience of modernisation needs to be described before answering this question. studies have been conducted to provide beck's risk theory with an empirical basis and to confront it with the contexts of non-western countries, including asian countries (see calhoun and the articles in the british journal of sociology ). these studies have underlined specific characteristics associated with modernisation in emerging asiatic countries. firstly, the rapidity of processes such as industrialisation, urbanisation and economic liberalisation, lead to the almost simultaneous development of first modernity and the transition to a second one, resulting in a compressed modernity ( beck and grande , chang , kyung-sup . secondly, 'global risks as a driving force of second modernity are more relevant in east asia as a result of the side effects of the rush to development' (han and shim : ) . thirdly, the economic and political transition has meant 'the protracted coexistence of socialist, capitalist or even (neo) traditionalist components of the political economy, thereby imposing an ultra-complex (compressed) modernity' as shown by kyung-sup ( : ) in analysing china. these works focus on global risks as a structural, objective factor and do little to document their local framing and local perception. the recent history of the socialist republic of vietnam illustrates this rush to development and the transition towards an ultra-complex modernity. in the s vietnam was considered one of the world's poorest countries (vietnam development report ) and was economically and politically isolated. the country is now classified as a middle income country by the international monetary fund and is a member of numerous international organisations and forums. following the establishment of the communist government in , the victory over american armed forces in and the invasion of cambodia in , vietnam suffered a us trade embargo and an international boycott. vietnam also lost considerable support following the collapse of the soviet union. in the s the domestic economic situation was a disaster, resulting in famines. in reaction, vietnam implemented from important economic and political reforms (known as doi moi). at the international level vietnam's objective was to become integrated in the international community. but according to do hien ( : , my translation) , at that time, 'winning back the confidence of the international community was an almost impossible challenge'. nevertheless, vietnam succeeded within a relatively short time. the country started by restoring its relationship with china following the end of the conflict in cambodia ( ) and then by amplifying its relations with neighbouring south-east asian countries. vietnam made an important gesture when it agreed to cooperate with the usa over the 'missing in action ' affair ( ) . this led to the lifting of the trade embargo ( ), after which vietnam regained access to international credit (from the asian development bank and the international monetary fund) and was integrated into the coalition of south-east asian countries in (do hien ) . when avian flu emerged in vietnam these successes were considered by vietnamese authorities as steps towards a longer term objective: vietnam's integration into the world trade organization. at the national level, the liberalisation of the former planned economy has provoked unprecedented economic growth with positive outcomes such as poverty alleviation, the reduction of malnutrition and increased wealth (vietnam development report ) . the political consequences are more complex. bao an and de tre´glode´( ) have shown how, through these reforms and in a very pragmatic way, vietnamese authorities combine contradictory forces: economic and social dynamics with ideological and political continuity, a project of modernisation with patriotic, historic and cultural references. according to these authors, the role of the state and the communist party has not been weakened by this modernisation process. the process is kept within the ruling system of a bureaucratic-authoritarian state with a single party. the state has retained its monopoly in decision-making and the party is responsible for guaranteeing the continuity of moral values throughout the economic development process. nevertheless, the growing gap between rules and practices opens space for initiatives but without allowing the emergence of a real opposition (bao an and de tre´glode´ ). these characteristics of vietnam's modernisation have affected vietnam's cooperation with the international community to deal with avian flu. the first human casualties caused by the re-emergence of the h n were officially recorded in vietnam and china in . this put vietnam, according to international organisations such as the who, oie and fao, in the sars virus is transmissible from human to human, but the mode of transmission of h n to humans was then unclear. the vietnamese authorities and the who had been criticised for their slow response to sars. in the case of avian flu, vietnamese authorities were supported by the international organisations (who, oie and fao) for a prompt answer. they took unprecedented measures: a massive culling operation of per cent of all poultry in less than three months (agrifood consulting international [aci] ), as well as the restriction of all transport of poultry across provincial and national borders: if there had been only avian flu, people would have thought the who was going mad, overreacting. but before, when we had the sars, the who were criticised for not acting quickly enough. (doctor, international medical cooperation, interview, may ) the vietnamese communist party published decrees and actively intervened in the preventative culling operation, mobilising the army as well as the party-affiliated associations of the patriotic front ( gue´nel and klingberg , tuong ) . the network of actors mobilised closely resembles that which is normally seen in this country in the event of floods, typhoons or even past armed conflicts: the rapidity of vietnam's response can be explained by its history. this country has had to mobilise the population on numerous occasions throughout the past. i was born in peacetime, but i am imbued with this vietnamese culture of collective struggle. (representative from the ministry of agriculture, interview, may ) as one expert in an international organisation noted: vietnamese people are accustomed and prepared to face situations of emergency. they do not have to worry about media, public opinion, or sectoral interests … and they have no complexes. moreover the chain of command, the communist party and the army, is very efficient. (international expert, interview, december ) in contrast with this initial mobilisation, avian flu lost its place on the political and media agenda a few months later. regular outbreaks were recorded among poultry but human mortality remained low compared with the past sars outbreak and other infectious diseases already present in vietnam. the population's anxiety receded: consumers resumed poultry consumption after a dramatic drop (figuie´and fournier ) and poultry farmers finally perceived avian flu as just another epizootic disease ( desvaux and figuie´ ) . the problem was reduced to a veterinary problem to be managed by the ministry of agriculture. at the same time, developed countries were adopting national protective strategies such as the production and stockpiling of vaccines and masks (gilbert ) . phase : avian flu, a modern risk in the last three months of the international community gave a new impetus and new orientation to the treatment of avian flu in vietnam. in the number of countries notifying h n to the oie increased dramatically and the virus reached europe (with the first human cases in europe occurring in turkey in january ), increasing the pandemic threat for western countries. the same year the us congress commissioned an assessment of the actions undertaken by the international community and by the main countries affected by the virus, including vietnam. the report underlined numerous inadequacies in the surveillance and control of the virus. in line with the lessons learned from terrorist attacks, the us government was now convinced that it should not rely for homeland security solely on the surveillance and the protection of its own territory but that it had to increase its involvement at the international level to manage the sources of threat (congressional research service [crs] ) . in september us president george w. bush, addressing the united nations world summit, announced his country's decision to invest in and coordinate the formation of a new international partnership aimed at preventing an influenza pandemic. the president required all countries to be transparent on their epidemiological status (bush ) . in addition, the appointment of a senior united nations system coordinator for avian and human influenza, dr nabarro, marked the globalisation of avian flu management. the who had already reinforced its presence in vietnam at the time of sars and it was now the turn of the fao to widen the scope of its local activity. bilateral cooperation developed primarily with the usa, as well as with japan and new zealand. ngos also increased their presence in vietnam (academy for educational development, association ve´te´rinaires sans frontie`res and care). the un agencies in vietnam supervised the coordination of the donors and demanded in the middle of a greater involvement from the vietnamese authorities: in particular, they asked for a direct and permanent line of communication with the vietnamese prime minister (interview). vietnam came under increased pressure to attend to the pandemic threat. un agencies asked for greater involvement from the ministry of health and the vietnamese government was pressed to formulate a plan for human pandemic influenza preparedness and responses (the red book). this was the condition for obtaining a portion of the funds that the international community had committed to this cause (interview). the us government succeeded in imposing the presence, at the who office in hanoi, of one of their military experts (from the center for disease control and prevention, atlanta) against the will of the vietnamese authorities (interview). vietnamese official government declarations became more frequent and the number of articles addressing the problem of avian flu in the press reached a new peak. the prime minister responded to un pressure by addressing the nation for the first time since the beginning of the epizootic disease through an official telegram (telegram no. ⁄ ttg-nn), in which he announced reinforced measures to prevent and fight against avian flu. new laws were produced with the assistance of the fao and oie (mard and moh ) . the participation of the private sector became more widely solicited. through new regulations, new hygiene standards, a credit policy and even local tax policies, the government consistently promoted the development of a modern industrial poultry farming sector to the detriment of small-scale farming (aci ). the state even passed the role of public health protection, traditionally its own responsibility (in particular in communist countries) onto the private sector, by a health ministry radio announcement in which people were told, 'if you don't want to catch the virus, buy your poultry at the supermarket'. why did vietnam, a country with a reputation of strong adherence to national sovereignty, adopt the international framing of avian flu as a pandemic threat? and what was the extent of their compliance as a result of this adoption? policy transfer studies (delpeuch ) have shown that policy transfer is not a purely rational process oriented towards problem-solving. many factors come into play when selecting and reframing imported policies, such as path dependency and cognitive and cultural factors. for the vietnamese government, there were two political issues associated with avian flu management. as noted by a european expert: europe came here to analyse the problem in a scientific manner and to define a strategy based on science. but the objective of the government is completely different! it aims at keeping stability in the country and to protect its reputation. (interview, april ) the first phase of avian flu management proved to be beneficial for political stability, the centralisation of power and the promotion of a nationalist project. following the deregulatory market reforms of , provincial authorities gained new economic power and autonomy from the central government. tuong ( ) has shown that the management of avian flu became an opportunity for the central government to affirm its authority, regardless of the local reality (as with the authoritarian imposition of massive culling measures). central authorities used avian flu to blame local authorities for all mismanagement, pointing to their incompetence and corruption. the media presented the victory over the virus as a question of national honour and as popular mobilisation behind the party against a new common enemy (gue´nel and klingberg , tuong ) . in contrast, during the second phase, the virus became an opportunity for vietnam to consolidate a -year period of reintegration into the international diplomatic community. when h n emerged, the usa, vietnam's former enemy, was the last obstacle to its entry to the world trade organisation (wto). vietnam had yet to complete bilateral negotiations with the usa in order to obtain the status of a permanent normal trade relations (pntr) nation from the us congress (for more details see the us association of southeast asian nations business council ). these negotiations were part of a vietnam-usa normalisation process depending on a number of key issues such as human rights, religious freedom, intellectual property rights and bird flu, as quoted by a us congress report (crs this is a question which concerns not only this country, but all the world's countries. we must share this responsibility. of course, the culling of chickens is a significant economic loss for the population, especially the poor, rural farmers … but the government is determined, and is also responsible to the rest of the world. (ministry of health representative, interview, december ) . for one of the international experts involved since the beginning, the first phase in vietnam's risk management was just a mistake: for a long period, vietnam has been seen as an enemy for the rest of the world. but during the last years, the government's objective has been to integrate the international community. when vietnamese authorities understood the global dimension of the risk [hpai], they reacted very quickly. sure, they made some mistakes in , but this did not last. (interview, april ) vietnam has been considered as being at the top of the class for complying with the requirements of the us administration and un agencies, as confirmed by many of interviewees. but what were the real consequences of such compliance? is it transformative cooperation or just lip-service? vietnam's compliance with international requirements brought risks to national sovereignty. the authorities adopted the framing of avian flu as a pandemic threat (that is as a risk of second modernity) and cooperated with the international community to manage a global manufactured uncertainty. they delivered transparent information on the outbreaks (according to our interviewees) and implemented a vaccination programme. nevertheless, changes in vietnamese policies have remained limited. firstly, in the field many regulations adopted by the authorities were not applied or were applied for a short period only. for example, a ban on duck breeding has never been applied and live poultry markets, however much they were prohibited, have quickly resumed. according to mard ( ) , the implementation of one major decision (decision on biosecurity measures in the avian chain) has been limited. this discrepancy between norms and practices is a common feature of vietnamese policy, according to bao an and de tre´glode´( ) : it is a way for vietnamese authorities to manage the contradictions of the country's development process: in this case, contradictions between the objective of international integration and the defence of national sovereignty. secondly, the authorities have recognised in their national strategy for avian flu (the red book) the need to rely on a wide web of stakeholders in order to manage the virus (international organisations, ngos and the private sector). however, these stakeholders have been kept away from the decision-making process: they do not take part in the national steering committee (nsc) for avian influenza disease control and prevention (established by decision no. ⁄ ⁄ qd-ttg, dated january ) . this committee brings together representatives of ministries (including agriculture, health, trade, finance, transport and the environment) but does not include any representatives of civil society and its discussions are confidential. international and foreign organisations were also excluded from this committee. debates with these organisations, and the coordination of their numerous activities, have been the role of the partnership for avian and human influenza (pahi), created in . according to one member of this partnership, this structure (the nsc and pahi) clearly indicates the strategy of the vietnamese authorities vis-a´-vis cooperation and protection of national sovereignty: the functioning of the nsc demonstrates the sovereignty of vietnam … the vietnamese government affirms that it is completely open [and] ready to furnish any information, but that does not mean that international organisations can intervene in the nsc. the information is divulged via the pahi to the international organisations. (expert from pahi, interview, april ) the democratic turn that, according to beck, could be produced by global risks did not occur in vietnam. and the capacity of transformations potentially induced by new global risks is shown to be limited compared to path dependency effects linked to vietnam political characteristics. as mentioned by one of our interviewees, a member of the pahi: vietnam plays the game because there is benefit to it. that is true that there are conditionalities linked to foreign aid. but donors are sometimes so naive. (interview, april ) there were dual benefits for vietnam at national and international levels. modern risks are characterised by their potential for political destabilisation because they question the capacity of states to protect their citizens. but being global, they also question states' sovereignty as well as their reputation in the eyes of the other countries over their contribution to global goods. however, in a very clever way, vietnam exploited a number of opportunities associated with avian flu, both keeping the international community at a safe distance while adeptly navigating the unfamiliar path of global governance, changing its image in the world from that of a carrier of a global health risk to one of a good global citizen and finally consolidating the communist heritage at a local level while advocating greater public health control via the market. this demonstrates the varieties of modernity. the vietnamese representatives interviewed during this research were proud to underline that, in managing avian flu, vietnam was not like china (because vietnam remained accountable) nor was it like laos (because vietnam did not relinquish its sovereignty when the avian flu broke out), and that it was not like indonesia (because vietnam had always shown cooperation). but vietnam's major success in avian flu management should be assessed from its primary result: vietnam became the wto's th member on january . this vietnamese case has been studied using the analytical framework offered by beck's world at risk theory. i have paid attention particularly to the constructed dimension of global risks, to the relations of definition as relations of domination and to the possibilities of instrumentalisation. this focus downplays global risks as structural factors that drive cosmopolitisation and democratisation. it also shows the community of fear to be a less powerful driver of cosmopolitisation than the community of trade. agrifood consulting international (aci) ( ) the economic impact of highly pathogenic avian influenza doi moi et mutations du politique risk society: towards a new modernity la socie´te´du risque globalise´revue sous l'angle de la menace terroriste, cahiers internationaux de sociologie varieties of second modernity: the cosmopolitan turn in social and political theory and research risk and 'risk society' in historical perspective the making of the risk-centred society and the limits of social risk research president of the united states of america exploring the international arena of global public health surveillance, health, policy and planning beck, asia and second modernity the second modern condition? compressed modernity as internalized reflexive cosmopolitization international responses to global spread of avian flu comprendre la circulation internationale des solutions d'actions publiques: panorama des policy transfer studies formal and informal surveillance systems risk society': the cult of theory and the millenium? les relations internationales du vieˆt nam depuis avian influenza in vietnam: chicken-hearted consumers? risk analysis world organization for animal health (oie), world health organization (who) ( ) unprecedented spread of avian influenza requires broad collaboration. fao ⁄ oie ⁄ who call for international assistance. press release. who media center available at ftp: ⁄ ⁄ ftp.fao.org ⁄ docrep ⁄ fao ⁄ ⁄ aj e ⁄ aj e les crises sanitaires de grande ampleur: un nouveau de´fi? paris: institut national des hautes etudes de se´curite´(inhes) press coverage of bird flu epidemic in vietnam redefining second modernity for east asia: a critical assessment the second modern condition? compressed modernity as internalized reflexive cosmopolitization provincial summary reports on implementing prime minister decision ⁄ qd-ttg. hanoi: ministry of agriculture and rural development avian and pandemic influenza. vietnam's experience. hanoi: ministry of agriculture and rural development and ministry of health la 'socie´te´du risque'. analyse et critique david nabarro warns of an inevitable influenza pandemic power, politics and accountability: vietnam's response to avian influenza available at http: ⁄ ⁄ www.usvtc.org ⁄ trade ⁄ wto ⁄ pntr memo available at http: ⁄ ⁄ www.oie.int ⁄ for-the-media ⁄ editorials ⁄ detail ⁄ article ⁄ protecting-the-world-from-emerging-diseases-linked-to-globalisation ⁄ vietnam consultative group world health organization (who) ( a) introduction to the ihr , world health organization, ihr brief, . available at http: ⁄ ⁄ www.who.int ⁄ ihr ⁄ ihrbrief en.pdf outbreak communication. world health organization handbook for journalists: influenza pandemic international health regulations. notification and other reporting requirements under the ihr a safer future: global public health security in the st century available at http: ⁄ ⁄ www.who. int ⁄ whr ⁄ ⁄ media_centre ⁄ slides_en influenza: cumulative number of confirmed human cases of avian influenza a(h n ) reported to who one world, one health. oie bulletins online, ⁄ world organization for animal health (oie) ( ) wahid interface. country information this research was conducted with the support of the gripavi and ardigrip projects, funded by the french ministry of foreign and european affairs and the french ministry of research. key: cord- -my g c authors: berger, a.; drosten, ch.; doerr, h. w.; stürmer, m.; preiser, w. title: severe acute respiratory syndrome (sars)—paradigm of an emerging viral infection date: - - journal: journal of clinical virology doi: . /j.jcv. . . sha: doc_id: cord_uid: my g c abstract an acute and often severe respiratory illness emerged in southern china in late and rapidly spread to different areas of the far east as well as several countries around the globe. when the outbreak of this apparently novel infectious disease termed severe acute respiratory syndrome (sars) came to an end in july , it had caused over probable cases worldwide and more than deaths. starting in march , the world health organization (who) organised an unprecedented international effort by leading laboratories working together to find the causative agent. little more than one week later, three research groups from this who-coordinated network simultaneously found evidence of a hitherto unknown coronavirus in sars patients, using different approaches. after koch’s postulates had been fulfilled, who officially declared on april that this virus never before seen in humans is the cause of sars. ever since, progress around sars-associated coronavirus (sars-cov) has been swift. within weeks of the first isolate being obtained, its complete genome was sequenced. diagnostic tests based on the detection of sars-cov rna were developed and made available freely and widely; nevertheless the sars case definition still remains based on clinical and epidemiological criteria. the agent’s environmental stability, methods suitable for inactivation and disinfection, and potential antiviral compounds have been studied, and development of vaccines and immunotherapeutics is ongoing. despite its grave consequences in humanitarian, political and economic terms, sars may serve as an example of how much can be achieved through a well-coordinated international approach, combining the latest technological advances of molecular virology with more “traditional” techniques carried out to an excellent standard. severe acute respiratory syndrome (sars) is the latest in a series of emerging infectious diseases, and certainly one of the most widely publicised. this acute and often severe respiratory illness seems to have emerged in southern china in late (world health organization, c) . it soon caused considerable international alarm, after several index cases had given rise to outbreaks of sometimes ଝ this review is dedicated to all those who were prepared to risk their lives to provide care to sars patients and control the first pandemic of the st century. * corresponding author. tel.: + - - - ; fax: + - - - . e-mail address: annemarie.berger@em.uni-frankfurt.de (a. berger). enormous scales, and when the disease's ability to spread to distant areas within a very short period of time became obvious (world health organization, d) . a definition was developed for suspected and probable sars cases, based on clinical and epidemiological criteria; it has since been modified on several occasions. while sars demonstrated very vividly that in the modern world with an enormous volume of intercontinental traffic, infectious agents may be spread rapidly across the globe, it also serves as an example of how modern technologyprovided there is the necessary will, determination, and coordination to make best use of it-may help in combating such threats with unprecedented speed and enormous success. sars is characterized clinically by fever followed by respiratory signs and symptoms which may lead to rapidly progressive respiratory failure. as of september , people have been notified to the world health organization (who) as fulfilling the criteria for "probable sars", and of these, have died from sars (http://www.who.int/csr/ sars/country/ /en/). what made sars-in contrast, e.g. to influenza-notorious is its propensity to cause hospital outbreaks; some of these have affected over people, including health care staff, other patients and visitors . in contrast to many other emerging viral infections such as ebola, hantavirus pulmonary syndrome, and nipah, sars also clearly demonstrated its ability for easy and rapid geographic spread. this is because the sars agent affected a generally rather mobile population, and because those infected normally remain well enough to travel for several days after onset of infectivity. on march , the who set up a worldwide network of virological laboratories investigating sars cases (world health organization, a) . the investigations conducted by the members of these networks were coordinated by who's department of communicable disease surveillance and response (csr) through normally daily telephone conferences and a password-protected internet website. thus results and planned further studies were communicated and views and comments exchanged almost in "real-time" which made possible the rapid progress in elucidating the aetiological agent. in its final form, this network comprised participating laboratories from ten countries (world health organization multicentre collaborative network for severe acute respiratory syndrome diagnosis, ). investigations had soon ruled out a novel influenza virus strain, possibly of avian origin, as the cause of sars, and then focussed on members of the paramyxoviridae family, including human metapneumovirus (hmpv), and chlamydia-like organisms, including chlamydia pneumoniae. however, further investigations did not confirm these findings; the said agents were indeed found in a number of sars patients but not in all (who multicentre collaborative networks for severe acute respiratory syndrome (sars) diagnosis, ). almost nobody knew at that stage that virologists in beijing had already discovered a new virus in samples from some of the earliest sars patients. however, the official line in china at the time was that the novel "atypical pneumonia" was caused by chlamydia (enserink, a) . nevertheless, before the end of march, laboratories in hong kong, germany, canada, and the united states of america found evidence of a novel coronavirus in patients with sars by cell culture, electron microscopy, and by polymerase chain reaction (pcr) using primers at low stringency designed for other agents followed by sequencing (peiris et al., b; drosten et al., a; ksiazek et al., ; poutanen et al., ; drosten et al., b) . these results could not rule out that very thorough and extensive testing had by chance led to the discovery of a novel agent that was not responsible for the new illness but rather an "innocent bystander". however, the sequences obtained in different parts of the world were shown to belong to the same, previously unrecognised, coronavirus (ruan et al., ) . it could also be shown that sars patients underwent seroconversion against this coronavirus, using cells infected with patient isolates as antigen for indirect immunofluorescent antibody tests (drosten et al., a; ksiazek et al., ; fig. ) . furthermore, no evidence of present or past infection with this agent could be detected in limited surveys of healthy control individuals not suffering from sars (ksiazek et al., ) . this strengthened the case for the novel coronavirus being the cause of sars, but only after it had been shown to cause a similar illness in artificially infected macaques could it be regarded as fulfilling all four of koch's postulates ; world health organisation multicentre collaborative networks for severe acute respiratory syndrome diagnosis, ) . on april , , less than a month after the laboratory network had been brought into existence, who officially announced that a new coronavirus, never before seen in humans or animals and now provisionally termed sars-associated coronavirus (abbreviated as sars-cov), was the cause of sars . coronaviruses are large, enveloped, positive-stranded rna viruses with a diameter of - nm. most but not all viral particles display the characteristic appearance of surface projections, giving rise to the virus family's name (corona, latin, = crown). they have the largest genomes of all rna viruses. based on their unique transcription strategy that involves the formation of "nested" mrna molecules (cavanagh, ) . within the coronaviridae, the genera torovirus and coronavirus (type species: infectious bronchitis virus, ibv) are distinguished. a unique feature of coronavirus genetics is a high frequency of rna recombination as a result of discontinuous transcription and polymerase "jumping" (lai and cavanagh, ) . one example is the porcine respiratory coronavirus (prcov), which evolved in the early s from the enteropathogenic porcine transmissible gastroenteritis coronavirus (tgev), known since the s (pensaert et al., ) . through a large deletion in the s gene, the virus acquired an altered tissue tropism, causing mild respiratory infections. based on homologies on the amino acid sequence level, the known coronaviruses can be divided into three groups. table gives an overview of coronavirus species, group assignment, host species, disease manifestation and availability of a vaccine. there are more than a dozen known coronaviruses affecting different animal species; whereas group i and ii coronaviruses affect various mammals, those in group iii infect birds. some of these cause major problems in the livestock industry or may affect companion animals; therefore, considerable efforts have been devoted to their control, including development of active immunisation. negative-stain transmission electron microscopy of respiratory samples from sars patients and of infected cell culture supernatants reveals pleomorphic, enveloped virus-like particles with diameters of between and nm (fig. ) . most but not all viral particles showed the characteristic coronavirus-like surface features (ksiazek et al., ) . in contrast to most coronaviruses, which infect only the cells of their natural host species and a few closely related species, the sars-cov is able to infect different cell cultures, such as african green monkey (cercopithecus aethiops) kidney cells (vero) and the human colorectal adenocarcinoma cell line (caco- ), causing a massive cytopathic effect (cpe) after as little as days or days (fig. ) . it should be mentioned that these cell lines were not commonly used for the isolation of human respiratory viruses. interestingly during cell culture passages of the frankfurt isolate a virus variant emerged with a nucleotide deletion of bases in the orf b . the biological significance of this finding remains to be elucidated. complete genome sequences of sars-cov were first published by a canadian laboratory and the centers for disease control (cdc), atlanta (marra et al., ; rota et al., ) . as of end-october , full genome sequences are available on http://www.ncbi.nlm.nih.gov/genomes/ sars/sars.html. the genomic data available so far from several sars-cov strains suggest that the novel agent does not belong to any of the known groups of coronaviruses, fig. . electron microscopy image of sars-cov particle from infected cell culture supernatant after ultracentrifugation, % formalin fixation and negative staining with uranyl acetate (photograph by h. r. gelderblom, robert koch institute, berlin, germany). including the two human coronaviruses (hcov) oc and e (drosten et al., a; marra et al., ; peiris et al., b; rota et al., ) , to which it is only moderately related (fig. ) . the sars-cov appears to be neither a mutant of a known coronavirus nor a recombinant between known coronaviruses (holmes, ) . it has been proposed that the new virus defines a fourth lineage of coronavirus (group iv) (marra et al., ) (fig. ) . however, more recently it was suggested that sars-cov may be an early split-off from the group lineage . the sequence analysis of sars-cov suggests that it is an animal virus with a still unknown natural host species that has recently developed the ability to productively infect humans. a genetically very close but not identical virus was found in wild animals (masked palm civets and a raccoon dog) from a wildlife market in guangdong . but uncertainties remain over the exact source of this virus; the animals sampled could have been infected from humans or another animal species (cyranoski and abbott, ; normile and enserink, ) . sequence analysis of different sars-cov isolates reveals two distinct genotypes. one genotype was linked with infections originating from hotel m in hong kong, the other one comprises isolates from hong kong, guangdong and beijing that had no association with hotel m (ruan et al., ; tsui et al., ) . to date, there is no information as to whether different sars-cov strains may have different degrees of virulence. there is little doubt that sars originated from guangdong province of southern china (breiman et al., ) . the first cases retrospectively identified as sars occurred there in november . interestingly, amongst these early cases there seems to have been a significantly higher percentage of food handlers, chefs, etc. than in the general population, lending further support to a zoonotic origin. the worldwide spread of sars-cov was triggered through a single infected individual from guangdong who spent some time in hong kong before succumbing to sars (chan-yeung and yu, ) . during that time he unwittingly infected several others that in turn gave rise to a series of outbreaks (centers for disease control and prevention, ) . through sometimes several generations of transmissions, this event carried the virus to different hong kong hospitals and communities as well as to vietnam, singapore, canada, the united states of america, and beyond to a total of countries and areas of the world (world health organization, d). the virus travelled in infected humans and was passed on over several generations, as reflected in the genetic relatedness of isolates from these countries. although china was late in admitting it, the sars-cov had unsurprisingly also been spread within mainland china; in the end, the worst affected area was the capital, beijing, with cases in total, which surpasses the count for guangdong with by far (world health organization western pacific region, country office china: http://www.wpro.who.int/wr/chn/chn sars.asp). the incubation period of sars is short, ranging from to days. large studies consistently noted a median incubation period of days (booth et al., ; lee et al., ; tsang et al., ) . however, the time from exposure to the onset of symptoms may vary considerably . the who continues to conclude that the current best estimate of the maximum incubation period is days (who update -sars case fatality ratio, incubation period, http://www.who.int/csr/sars/archive/ a/en/). based on the latest data, the case fatality ratio is estimated to be < % in persons aged years or younger, % in persons aged - years, % in persons aged - years, and greater than % in persons aged years and older ; who update -sars case fatality ratio, incubation period, http://www.who.int/csr/sars/ archive/ a/en/). pregnant women with sars appear to have a worse prognosis and a higher mortality. therefore, early delivery or termination of pregnancy should be considered in those who are seriously ill with sars. for women who are relatively well with sars, however, there seems to be no reason for elective preterm delivery, such as reducing the risk of materno-fetal transmission (wong et al., a) . compared with adults and teenagers, sars seems to take a less aggressive clinical course in younger children (hon et al., ) . multivariable analysis showed that the presence of diabetes, advanced age or other comorbid conditions were independently associated with a poor outcome (booth et al., ; donnelly et al., ; fowler et al., ) . at the present time, with no new cases-apart from the isolated laboratory-acquired one-having been reported since june , sars-cov has apparently been driven out of the human population (world health organization, d) . in the meantime, who has issued a consensus document on sars epidemiology (who department of communicable disease surveillance and response, ). the pattern of geographic spread of sars was similar across all affected areas: typically, a patient with sars arrived from a previously affected area, was not identified as such when hospitalised, and thus infected health care workers, other patients and hospital visitors; these then infected their close contacts, and then the disease moved into the larger community (hawkey et al., ) . the virus seems to be spread predominantly by respiratory droplets over a relatively close distance , however, at least under some circumstances direct and indirect contact with respiratory secretions, faeces or animal vectors may also lead to transmission (hong kong department of health, ; who environmental health team, ; tsang et al., ; ng, ) . shedding of sars-cov in faeces and urine also occurs but its significance is unknown. the duration of infectivity is still unclear. faecal shedding seems to last for several weeks; this however does not necessarily mean that there is sufficient excretion of infectious viral particles to infect other individuals (peiris et al., a) . practising stringent droplets and contact precaution significantly reduces the risk of infection after exposure to patients with sars. therefore, the protective role of the mask suggests that the main route of transmission is by droplets . sars-cov spreads more efficiently in sophisticated hospital settings. evidence suggests that certain procedures, such as intubation under difficult circumstances and use of nebulizers increase the risk of infection . the only case of laboratory-acquired sars-cov transmission so far occurred in singapore in september . it involved a postgraduate who worked in a virology laboratory. subsequent investigation showed inappropriate laboratory standards (who severe acute respiratory syndrome (sars) in singapore-update , http://www.who.int/csr/ don/ /en); no secondary transmission arose from this case. it demonstrates the need for optimal biosafety precautions in laboratories working with sars-cov; these constitute the only places on earth where sars-cov is currently known to still exist and might be at the source of a re-emergence. blood transfusions or administration of blood products have not been implicated in transmission anywhere. this is despite the demonstration of viraemia during the clinical phase of the illness, albeit at low to moderate titres (drosten et al., a) . nevertheless, the potential of blood-borne transmission led to the early implementation of measures such as exclusion of possibly exposed individuals from the donor pool. the sars-cov is only moderately transmissible. a single infectious case will infect about three secondary cases (lipsitch et al., ; riley et al., ) . nevertheless, the clusters of cases in hotel and apartment buildings in hong kong show that transmission of the sars-cov can be extremely efficient. attack rates in excess of % have been reported. one common observation in various areas was the occurrence of so-called "super-spreaders", i.e. individuals that transmit the infection to at least ten others (world health organization, b). these "super-spreaders" were mostly very ill and often died from sars, and invariably serious lapses in infection control precautions had occurred during their management. so far there is no evidence that differences in virus strains may be responsible for the "super-spreader" phenomenon. there is also no firm evidence suggesting that subsequent transmissions led to clinically less severe illness, possibly through attenuation of the virus. it is also unclear why children are relatively under-represented amongst sars cases, and why on average they seem to suffer less severe sars illness. studies on the stability of the new sars-cov demonstrate the virus is more stable at room temperature than the previously known human coronaviruses (sizun et al., ) . the virus has been shown to survive for up to hours on plastic surfaces and up to days in diarrhoea. nevertheless the virus loses infectivity after exposure to different commonly used disinfectants and fixatives. heat exposure at • c quickly reduces infectivity (world health organization (who): first data on stability and resistance of sars-cov compiled by members of who laboratory network available at http://www.who.int/csr/sars/ survival /en/index.html). as defined by the who, a person is suspected to have sars if she has documented high fever (> • c), plus cough or breathing difficulty, and has been in contact with a person believed to have had sars, or has a history of travel to or stay in a geographic area where documented transmission of the illness has occurred, during the days prior to onset of symptoms ("suspect case"). a suspect case with infiltrates consistent with pneumonia or respiratory distress syndrome (rds) by chest x-ray is reclassified as a probable case. the revised case definition as of may , (see: http://www.who.int/csr/sars/casedefinition/en/) for the first time includes virus-specific laboratory results: a suspect case that tests positive for sars-cov in one or more assays should also be reclassified as probable. while recommendations have been issued for the use of laboratory methods for sars-cov (see: http://www.who. int/csr/sars/labmethods/en/), there are, however, at present no defined criteria for negative sars-cov test results to reject a diagnosis of sars. given the rather low shedding of sars-cov from the upper respiratory tract (drosten et al., a) , and the insufficient sensitivity of presently available laboratory methods, premature exclusion on the basis of negative test results may lead to tragic consequences. positive laboratory test results for other agents able to cause atypical pneumonia may serve as exclusion criteria; according to the case definition, a case should be excluded if an alternative diagnosis can fully explain the illness. nevertheless, the possibility of dual infection must not be ruled out completely. the required epidemiological linkage has repeatedly proven to be problematic. until an area is recognised as being affected, only imported cases fulfil the criteria for sars but not those who became infected locally through contact with unrecognised cases. thus, precious time may be lost until cases are recognised and appropriate measures taken. a thorough analysis showed that the existing who criteria lack sensitivity in the pre-hospital setting (rainer et al., ) . this again may be problematic as it may delay appropriate management of sars cases. the human coronaviruses known prior to march are difficult to propagate in cell cultures. their disease associations-generally mild respiratory illness ("common cold"), enteric and rarely possibly neurological disease-led to their widespread neglect in medical virology; only few groups worked on various scientific aspects, and very few laboratories offered routine diagnostic tests, mainly by pcr. sars-cov, on the other hand, is readily propagated in vitro and may also be detected by pcr and indirectly through antibody testing. nevertheless, and despite considerable progress in this field, much remains to be done until laboratory tests become a useful tool for the management of sars cases (world health organization multicentre collaborative network for severe acute respiratory syndrome diagnosis, ) . the presence of the infectious virus can be detected by inoculating suitable cell cultures (e.g., vero cells) with patient specimens (such as respiratory secretions, blood or stool) and propagating the virus in vitro. once isolated, the virus must be identified as sars-cov using further tests. according to international consensus, such work has to be performed under biosafety level (bsl) three conditions. sars-cov-specific rna can be amplified from various clinical specimens, especially in respiratory secretions and in stool, by pcr. high concentrations of viral rna of up to million molecules per millilitre were found in sputum. viral rna was also detected, albeit at extremely low concentrations, in plasma during the acute phase and in faeces during the late convalescent phase, suggesting that virus may be shed in faeces for prolonged periods of time (drosten et al., a) . a commercial real-time rt-pcr test kit containing primers and positive and negative controls developed by the bernhard nocht institute (http://www.bnihamburg.de/) is available (http://www.artus-biotech.de). an inactivated standard preparation is also available for diagnostic purposes through the european network for imported viral infections (enivd; http://www.enivd.de). enivd is also preparing for an international external quality assessment scheme for sars-cov assays. the existing pcr tests cannot rule out, with certainty, the presence of sars-cov in patients . on the other hand, contamination of samples in laboratories performing pcr may lead to false-positive results, unless appropriate precautions are taken. various methods were developed for the detection of antibodies produced in response to infection with sars-cov by probably virtually all patients. the first type of antibody test to be employed was the immunofluorescence assay (ifa). using cells infected with the patient's own virus isolate and an antihuman igg:fitc conjugate, we were able to demonstrate specific seroconversion in the two frankfurt sars patients (drosten et al., a; fig. ). an enzyme-linked immunosorbent assay (elisa) was developed that detects antibodies in the serum of sars patients and reliably yields positive results at around day after the onset of illness (world health organization multicentre collaborative network for severe acute respiratory syndrome diagnosis, ). the neutralisation test (nt) assesses and quantifies, by means of titration, the ability of patient sera to neutralise the infectivity of sars-cov on cell culture; the nt titre may therefore be correlated to clinical immunity although this has yet to be demonstrated. however, nt is limited to institutions with bsl- facilities. the only antibody test commercially available so far is an ifa which yields a positive result from about day after the onset of illness (euroimmun, lübeck, germany). as the diagnosis of sars is based entirely on a set of clinical and epidemiological criteria so far, reported case numbers are likely to include a substantial number of non-sars patients. therefore, recovered patients should be tested systematically for specific sars-cov antibody reactivity to confirm their diagnoses in retrospect and thus allow a better understanding of epidemiological and other features . although electron microscopy has an important role in the rapid diagnosis of infectious agents in emergent situations (hazelton and gelderblom, ) , it has provided only circumstantial evidence in the case of sars. when a virus-like agent was first visualised in clinical material from sars cases by electron microscopy, its classification was ambiguous; it later turned out to be human metapneumovirus (poutanen et al., ) . even in cases in whom coronavirus-like particles were detected, these could not be distinguished from the 'classic' human coronaviruses. no specific treatment recommendations can be made at this time. primary measures include isolation and the implementation of stringent infection control measures to effectively prevent further transmissions. empiric therapy should include coverage for organisms associated with any community-acquired pneumonia of unclear aetiology, including agents with activity against both typical and atypical respiratory pathogens. treatment choices may be influenced by severity of the illness. oxygen supplementation is often necessary, and severe cases seem to do better if intensive care including artificial respiration is commenced early (so et al., ) . efforts are underway at various institutions to assess potential anti-sars-cov agents in vitro. ribavirin, a "broad spectrum" agent active against various rna viruses has also been used clinically in sars patients (koren et al., ) , but seems to lack an in vitro effect (cinatl et al., a) . corticosteroids were widely used in sars patients, particularly in china. the rationale for their administration is the observation that tissue changes suggest that part of the lung damage is due to cytokines induced by the virus (peiris et al., a) . some clinical reports also underline their usefulness (zhao et al., ) . other therapies are being explored, such as convalescent plasma (wong et al., b) or normal human immunoglobulin which may be beneficial through an immunomodulatory effect or through acting against agents causing secondary infections. preliminary clinical data suggest that protease inhibitors used for anti-hiv therapy, lopinavir and nelfinavir (yamamoto n, personal communication), might have some efficacy, both as initial therapy and in the rescue setting. hong kong researchers reported at the who global conference on sars in kuala lumpur in june that sars patients treated with kaletra (lopinavir with low-dose ritonavir) plus ribavirin experienced a % reduction in death rate. while efforts are underway to develop more targeted anti-sars-cov approaches, broad screening of available substances in vitro has led to some potentially important clues. recently glycyrrhizin, a compound found in liquorice roots (glycyrrhiza glabra l.), was reported to have good in vitro activity against sars-cov (cinatl et al., a) . the mechanism of glycyrrhizin's activity against sars-cov is unclear. glycyrrhizin has previously been used to treat patients with hiv- and chronic hepatitis c virus . interestingly, this compound may be contained in some of the herbal preparations widely used in sars patients in china as part of traditional chinese medicine (lin et al., ) . furthermore, interferons inhibit sars-cov in vitro. in a recent study (cinatl et al., b) , interferon ß was more potent than interferon ␣ or ␥. therefore, it could become a drug of choice in future, alone or in combination with other antiviral drugs. the rapid success in identifying the causative agent of sars results from a collaborative effort-rather than a competitive approach-by high-level laboratory investigators making use of all available techniques, from cell culture through electron microscopy (hazelton and gelderblom, ) to molecular techniques, in order to identify a novel agent. hopefully this approach, coordinated by who, will serve as a model for future instances of emerging infections that will undoubtedly take place (ludwig et al., ) . despite the exemplary efforts that led to the identification of the causative novel coronavirus and allowed enormous knowledge about it to be accumulated within only a few months, it is maybe surprising that this success in terminating the outbreak has to be attributed to "old-fashioned" measures such as rapid and strict isolation of suspect cases and thorough contact tracing (world health organization, c); one is left wondering whether the same might also have been achieved without knowledge of the aetiology. thanks to an internationally well-coordinated and in most cases timely and determined response no new cases of sars have been notified since june . several countries reported sars cases imported from areas reporting outbreaks but did not experience secondary transmission; likewise, vietnam was the first country to demonstrate that-through a combination of early detection and public alert followed by decisive public health action and often heroic efforts by individuals-further transmission could be curtailed (reilley et al., ) . the absence of new clinical cases worldwide suggests that sars-cov no longer circulates within the human population; however, the possibility of clinically "silent" infections or of long-term virus carriers cannot be ruled out completely. furthermore, the origin of the agent remains obscure; sars-cov or a closely related virus persisting in a hitherto unidentified animal reservoir may yet again cross the species barrier and lead to human outbreaks. numerous questions relating to the epidemiology of sars have yet to be answered (normile and enserink, ; breiman et al., ) . at the time of writing (october ) it is completely uncertain whether sars will ever reappear. it is unclear whether seasonal recurrences may occur. in southern china, unlike europe and north america, the annual influenza peak incidence is from march to july (huang et al., ); thus, it shows a similar epidemic curve as the sars outbreak in (enserink, b) . the advent of the next 'flu season will pose considerable problems, given the lack of reliable laboratory methods for the early diagnosis of sars. the case definitions, too, will need to be adjusted to a world without sars; in theory, new cases are "impossible" as the criterion of an epidemiological link cannot be fulfilled. precious time may therefore be lost before a reappearance is detected. vigilance for sars must clearly be maintained (see: alert, verification and public health management of sars in the post-outbreak period- august -rationale for continued vigilance for sars; http://www.who.int/csr/sars/postoutbreak/ en/). for this purpose, who has defined three geographical zones according to their presumed risk for a sars recurrence: a potential zone of re-emergence, comprising guangdong and other areas where animal-to-human of sars-cov might occur; nodal areas, comprising hong kong, vietnam, singapore, canada, and taiwan, with sustained local transmission in spring or entry of numerous persons from the potential zone of re-emergence; and low risk areas. sars-related vigilance should be staged according to the zone in which a particular area is situated; for low risk areas, surveillance should be for clusters of "alert" cases among health care workers, other hospital staff, patients and visitors in the same health care unit. a sars alert is defined as two or more health care workers or hospital-acquired illness in at least three individuals (health care workers and/or other hospital staff and/or patients and/or visitors) in the same unit fulfilling the clinical case definition of sars and with onset of illness in the same -day period. in the other zones, this should be supplemented by enhanced surveillance, plus special studies for sars-cov infections in animal and human populations in the potential zone of re-emergence. besides improving existing detection assays-for instance, pcr methods based on the amplification of the nucleoprotein gene may be intrinsically more sensitive, due to the coronaviral transcription strategy , and thus be valuable for early diagnosis-further laboratory research needs to include detailed physico-chemical analysis of sars-cov proteins to allow the development of novel compounds based on targeted drug design (anand et al., ) . although an effective vaccine cannot be expected to be available soon, the relative ease with which sars-cov can be propagated in vitro is clearly helpful. a suitable animal model for sars may be available in the form of cynomolgus macaques (macaca fascicularis) . while the availability of vaccines against animal coronaviruses, such as avian infectious bronchitis virus, transmissible gastroenteritis coronavirus of pigs, and feline infectious peritonitis virus, is encouraging, the obvious lack of protective immunity in humans after infection with hcov oc and e is not. there is also currently no commercial veterinary vaccine to prevent respiratory coronavirus infections, except for infectious bronchitis virus infections in chickens. further research is also urgently needed to determine whether immune pathogenesis plays a rôle in sars or whether immune enhancement may occur, the chances of developing an effective and safe vaccine therefore remain uncertain. it is to be hoped that after such an encouraging start in an atmosphere of open collaboration and mutual trust, progress in sars-cov research will not be impeded by patent matters (gold, ) . coronavirus main proteinase ( clpro) structure: basis for design of anti-sars drugs clinical features and short-term outcomes of patients with sars in the greater toronto area role of china in the quest to define and control severe acute respiratory syndrome update: outbreak of severe acute respiratory syndrome-worldwide outbreak of severe acute respiratory syndrome in hong kong special administrative region: case report 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title: beyond the ‘nanny state’: stewardship and public health date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: wh aaqlu background: some public health measures restrict personal freedom more than others, and deciding what type of measure will be appropriate and effective has long been a problem for policy makers. existing bioethical frameworks are often not well suited to address the problems of public health. methods: the nuffield council on bioethics set up an expert working party to examine the ethical issues surrounding public health in january . following evidence gathering and a public consultation exercise, the council published its conclusions and recommendations in the report ‘public health: ethical issues’ in november . results: a spectrum of views exists on the relationship between the state's authority and the individual. the council set out a proposal to capture the best of the libertarian and paternalistic approaches, in what it calls the ‘stewardship model’. this model suggests guiding principles for making decisions about public health policies, and highlights some key principles including mill's harm principle, caring for the vulnerable, autonomy and consent. an ‘intervention ladder’ is also proposed, which provides a way of thinking about the acceptability of different public health measures. the report then applies these principles to a number of case studies: infectious diseases, obesity, alcohol and tobacco, and fluoridation of water supplies. conclusions: the idea of a ‘nanny state’ is often rejected, but the state has a duty to look after the health of everyone, and sometimes that means guiding or restricting people's choices. on the other hand, the state must consider a number of principles when designing public health programmes, and justification is required if any of these principles are to be infringed. the nuffield council on bioethics is an independent body that identifies, examines and reports on ethical questions raised by advances in biological and medical research. the council seeks to contribute to policy-making and stimulate debate in bioethics. it has published major reports on a range of topics, including genetic screening, healthcare research in developing countries, research involving animals, and the forensic use of dna. in january , the council set up a working party to examine the ethical issues surrounding public health. this was chaired by lord krebs, and included members with expertise in health economics, law, philosophy, public health policy, health promotion and social science. this article summarizes some of the conclusions and recommendations that were published in the report 'public health: ethical issues' in november , and presented to the uk public health association annual public health forum in april . public health has been defined as 'the science and art of preventing disease, prolonging life and promoting health through the organised efforts of society'. but whose job specifically is it to ensure that we lead a healthy life? is it entirely up to us as individuals to choose how to lead our lives, or does the state also have a role to play? also, if the state does decide it should intervene, what type of intervention would be most appropriate and effective? the nuffield report presents an ethical framework that aims to help answer the question of when and how the state should act. a question that was fundamental to the council's inquiry was the relationship between the state's authority and the individual. a spectrum of views exists on this matter, from those who give priority to the individual, to those who believe that the collective interests of the population as a whole are the most important. the libertarian perspective finds that the authority of the state is limited to ensuring that members of the population are able to enjoy the 'natural' rights of man, such as life, liberty and property rights, e-mail address: chancellor@gla.ac.uk public health j o u r n a l h o m e p a g e : w w w . e l s e v i e rh e a l t h. c om / j ou r na l s / pu b h without interference from others. the libertarian state does not see the promotion of the welfare of its population as its proper role. at the other end of the spectrum is what can be called the 'collectivist' point of view. there are several forms, such as utilitarian and social contract approaches. the primary aim of the utilitarian approach is to maximize utility by focusing on achieving the greatest possible collective benefit. this means that actions or rules are generally measured by the degree to which they reduce pain and suffering, and promote overall happiness and wellbeing. in principle, they may allow the welfare or interests of some people to be 'sacrificed' if this were to lead to an increase in overall welfare. the social contract approach finds that the state's authority is based on the collective will of a community (e.g. as expressed in a democratic vote) to live together as an enduring nation state. this position will typically favour measures to promote the welfare of its citizens, including public goods and services of all kinds. there are, of course, a range of intermediate positions in between these two ends of the spectrum. essentially, they would recognize that the state should uphold certain fundamental individual rights, but also that it has a responsibility to care for the welfare of all citizens. these welfare considerations may include ensuring that all have a fair opportunity to make a decent life for themselves, and that efforts are made to level out unfair inequalities. positions of this type are generally thought of as liberal. most modern western states are, according to this analysis, liberal. an important question is how far it is proper for the state to introduce programmes that interfere, to different degrees, in the lives of its population in order to reduce the risks to the health of all or some of them. one way to start thinking about resolving this tension is provided by the 'harm principle', established by the philosopher john stuart mill. this suggests that state intervention is primarily warranted where an individual's actions affect others, i.e. coercion is legitimate where it acts to avoid harm to third parties. mill's harm principle was not limited to preventing harm to others. he also said: 'those who are still in a state to require being taken care of by others, must be protected against their own actions as well as against external injury.' so, mill recognized that the state can rightfully intervene to protect children, and other similar vulnerable people who require protection from, for example, damaging their own health. mill also saw the importance of educating and informing people so that they can make up their own minds about how to lead their life. hence, although mill's discussion of the harm principle shows that he would strongly oppose public health programmes which simply aim to coerce people to lead healthy lives, he is likely to support programmes which seek to 'advise, instruct and persuade' them so that they can make informed decisions about, for example, what to eat, how to exercise and so on. building on the harm principle, the council identified several further issues that are important to public health: individual consent, health inequalities, changing behaviour and community. the concept of consent is rightly at the centre of the practice of clinical medicine. consent for public health measures, however, is more complex. the practicalities of requiring each individual to consent to population-based interventions is extremely difficult, and may be impossible when rapid action is required. other mechanisms need to be identified. particular groups of people may differ in their health status, have varying health needs and respond differently to particular programmes. the uneven burden of ill health among different groups raises not only practical issues, but also the question of whether public health programmes should seek to reduce health inequalities. the council viewed the reduction of health inequalities as central to any public health programme. public education and information have a key role in the liberal framework, since they are non-coercive ways of bringing about improvements in health. however, long-term behaviour change is a major challenge. for example, information campaigns were not very effective in getting people to wear seatbelts; legislation was much more effective. the council used the term 'community' to describe the value of belonging to a society in which each person's welfare, and that of the whole community, matters to everyone. a shared commitment to collective ends is a key ingredient in public support for programmes aimed at securing goods that are essentially collective. the initial liberal framework therefore needs to be revised to make it less individualistic, and to better accommodate the value of the community. does this mean that we need to advocate paternalism, usually understood as the 'interference of a state or an individual with another person, against their will, and justified by a claim that the person interfered with will be better off or protected from harm'? the council suggests that it does not. in its report, the council set out a proposal that it considers appropriate to capture the best of the libertarian and paternalistic approaches, in what it calls the 'stewardship model'. the concept of stewardship means that liberal states have responsibilities to look after important needs of people, both individually and collectively. therefore, they are stewards to individual people, taking account of different needs arising from factors such as age, gender, ethnic background or socio-economic status, and to the population as a whole. , in the author's view, the notion of stewardship gives expression to the obligation on states to seek to provide conditions that allow people to be healthy, especially in relation to reducing health inequalities. the lists below summarize the core characteristics that should be included in public health programmes carried out by a stewardship-guided state. concerning goals, public health programmes should: aim to reduce the risks of ill health that people might impose on each other; aim to reduce causes of ill health by regulations that ensure environmental conditions that sustain good health, such as the provision of clean air and water, safe food and decent housing; pay particular attention to the health of children and other vulnerable people; promote health not only by providing information and advice, but also with programmes to help people to overcome addictions and other unhealthy behaviours; aim to ensure that it is easy for people to lead a healthy life, for example by providing convenient and safe opportunities for exercise; ensure that people have appropriate access to medical services; and aim to reduce unfair health inequalities. in terms of constraints, such programmes should: not attempt to coerce adults to lead healthy lives; minimize interventions that are introduced without the individual consent of those affected, or without procedural justice arrangements (such as democratic decision-making procedures) which provide adequate mandate; and seek to minimize interventions that are perceived as unduly intrusive and in conflict with important personal values. these positive goals and negative constraints are not listed in any hierarchical order. the implementation of these principles may, of course, lead to conflicting policies. however, in each particular case, it should be possible to resolve these conflicts by applying those policies or strategies that achieve the desired social goals while minimizing significant limitations on individual freedom. various third parties also have a role in the delivery of public health. these may be medical institutions, charities, businesses, local authorities, schools and so on. corporate agents whose activities affect public health include businesses such as food, drink, tobacco, water and pharmaceutical companies, owners of pubs and restaurants, and others whose products and services can either contribute to public health problems or help to alleviate them. in the same way that one would not judge the ethical acceptability of actions of individuals by merely assessing whether or not they have broken the law, it is reasonable to argue that commercial companies have responsibilities beyond merely complying with legal and regulatory requirements. genuine corporate social responsibility clearly has a role to play in public health. however, if there is a lack of corporate responsibility, or a 'market failure', it is acceptable for the state to intervene where the health of the population is at significant risk. there are two main types of evidence relevant to public health: evidence about causes of ill health, and evidence about the efficacy and effectiveness of interventions. achieving an ethical public health policy may seem straightforward: data on a particular public health problem need to be assessed, and an evidence-based strategy that can be justified in ethical terms needs to be adopted. however, even where every reasonable step has been taken to ensure that evidence is robust, in practice it is often incomplete or ambiguous, and will usually be contested. thus, scientific evidence does not necessarily lead to a clear policy that is likely to be the most effective. there are several other factors that are important for successfully planning and implementing public health policies, such as the perception of risk, the notion of a precautionary approach, individual choice, preservation of autonomy, and targeting of at-risk groups. the challenge for public health measures at the population level is to achieve the right balance when several of these goals have to be met simultaneously. personal behaviours can have a significant effect on health, and a range of different interventions can be used to attempt to change the behaviour of individuals or communities, such as regulation, taxes, subsidies and incentives, and provision of services and information. to assist in thinking about the acceptability and justification of different policy interventions to improve public health, the council devised what it calls the 'intervention ladder'. in general, the higher the rung on the ladder at which the policy maker intervenes, the stronger the justification has to be. eliminate choice; for example, through compulsory isolation of patients with infectious diseases. restrict choice; for example, removing unhealthy ingredients from foods, or unhealthy foods from shops or restaurants. guide choice through disincentives; for example, through taxes on cigarettes, or by discouraging the use of cars in inner cities through charging schemes or limitations of parking spaces. guide choices through incentives; for example, offering tax breaks for the purchase of bicycles that are used as a means of travelling to work. guide choices through changing the default policy; for example, in a restaurant, instead of providing chips as a standard side dish (with healthier options available), menus could be changed to provide a more healthy option as standard (with chips as an option available). enable choice; for example, by offering participation in a national health service (nhs) stop smoking programme, building cycle lanes or providing free fruit in schools. provide information; for example, campaigns to encourage people to walk more or eat five portions of fruit and vegetables per day. do nothing or simply monitor the current situation. there are a number of factors influencing the effectiveness of a public health intervention. these might include, for example, an unwillingness among individuals to change; whether there has been democratic engagement; the existence of commercial interests; the influence of the media; the views of ethnic, religious, voluntary and single issue groups; social movements; and economic issues, both personal and national. to illustrate how the factors discussed so far are born out in practice, the council considered a number of case studies and presented recommendations for policy makers within each. in europe and other western countries, death rates from infectious diseases have decreased over the past century. however, such diseases still account for over % of deaths and around one in three general practitioner visits in the uk. information about rates of infection and the emergence of new diseases is crucial for planning public health interventions. collecting anonymized data is not seen as very intrusive, but nonanonymized data interferes more with a person's privacy. when a serious outbreak emerges, it may be necessary for governments to introduce quite stringent, liberty-infringing policies to control its spread, for example by isolating those who are infected. the council concluded that to assess and predict trends in infectious diseases, it is acceptable for anonymized data to be collected and used without consent, as long as any invasion of privacy is reduced as far as possible. it may be ethically justified to collect non-anonymized data about individuals without consent if this means that significant harm to others will be avoided. highly intrusive measures to control infectious diseases, such as quarantine and isolation, would only be justified where there is a real risk of harm to others that could be reduced significantly. outbreaks of infectious diseases can have global implications. all cases of certain serious diseases such as severe acute respiratory syndrome and new strains of influenza must be reported to the world health organization. however, different countries have different capacities for monitoring and reporting infectious diseases. the council concluded that countries such as the uk should provide assistance to developing countries to enable effective surveillance of infectious diseases. vaccination programmes protect individuals against infection and, in many cases, also bring about 'population immunity'. more directive policies, such as penalties for those who do not comply, may achieve higher levels of vaccine uptake. the council concluded that vaccination policies that go further than simply providing information and encouragement to take up the vaccine may be justified if they help reduce harm to others, and/or protect children and other vulnerable people. this would need to take account of the risks associated with the vaccination and the disease itself, the seriousness of the threat of disease to others, and whether a directive measure would be more effective than a voluntary measure. after weighing up the evidence and ethical considerations, the council concluded that there is not sufficient justification in the uk for moving beyond the current voluntary system for routine childhood vaccinations. being overweight or obese is a risk factor for several health conditions, including diabetes, stroke, some cancers, and lung and liver problems. the number of people who are obese has increased substantially over the past few decades in the uk and in many other countries. the uk currently has the highest rate of obesity in europe, and a recent report estimated that % of adult men, % of adult women and approximately % of all children under years of age could be obese by . the causes of obesity are complex and there are no simple solutions. to help people to lead an active life, the council concluded that town planners and architects should be trained to encourage people to be physically active through the design of buildings, towns and public spaces. several different ways of providing front-of-pack information on food packaging have been introduced, and in , a major study on whether food labelling contributes to healthier choices was commissioned by the food standards agency. the results of the study are expected in the spring of . the council concluded that the scheme that is found to be most effective should be taken up. where industry fails to do this, there is an ethical justification for introducing legislation. increasing levels of childhood obesity are a particular concern. children require special protection from harm, and are particularly vulnerable due to their limited ability to make genuine choices, and their susceptibility to influences such as food marketing. the council concluded that there is an ethical justification for the state to intervene in schools to achieve a more positive attitude towards healthy eating, cooking and physical activity. stronger regulation of advertising food to children should be considered. it has been argued that if a person's behaviour has contributed to their need for nhs treatment, they should not have the same access to treatment as other people. obesity, however, is often related to factors outside the individual's control, such as living in an environment that makes it difficult to exercise or eat healthily. the council concluded that it would generally be inappropriate to deny nhs treatment to people simply on the basis of their obesity. however, persuading them to change their behaviour could be justified, provided that this would make the medical intervention more effective and that they were offered assistance. excessive drinking is associated with major health problems and also affects third parties, for example through drink driving and violence. the number of deaths from medical conditions caused by alcohol consumption doubled between and in the uk. for tobacco, regular smoking of even a small number of cigarettes is harmful to the health of the smoker and people around them. in the uk, smoking was associated with one in six of all deaths between and . therefore, the banning of smoking in enclosed public places in the uk was a welcome development. increasing tax on alcohol and restricting the hours of sale have been shown to be effective in reducing alcohol consumption. however, the uk government's policies on alcohol have focused on public information campaigns and voluntary labelling schemes; measures that have been shown to be ineffective. the council concluded that measures that have been found to be effective in reducing alcohol consumption should be implemented by the uk government. these include increasing taxes on alcoholic beverages and restricting hours of sale. the arguments in favour of banning smoking in public spaces can also be used to support banning it in homes where children are exposed to smoke. however, this would be extremely difficult to enforce without compromising privacy. the council concluded that there may be exceptional cases where children would be at such a high risk of harm from passive smoking, such as if they had a serious respiratory condition, that intervention in the home may be ethically acceptable, although any such case would usually need to be decided in court. corporate social responsibility is especially problematic in the case of the tobacco industry; the best strategy would simply be not to market the product. nevertheless, the council believes that the industry does have a role to play in harm reduction, particularly in an international context. it concluded that policies on selling and advertising tobacco and alcohol that provide the greatest protection to consumers should be adopted worldwide. the members of the uk tobacco manufacturers' association and other companies involved with tobacco products should implement a voluntary code of practice to achieve this. fluoridation involves adding fluoride to the water supply with the aim of improving dental health. at present, approximately % of the uk population receives a water supply that has been fluoridated to a certain level or has a similar amount of fluoride present naturally. there has long been debate over whether fluoridation schemes should be rolled out in other areas of the uk. fluoridation programmes have been controversial because, although fluoridation has been implemented in some areas for several decades, there is little high-quality evidence available on the benefits and harms, making it difficult to quantify them. in addition, fluoridated water is either supplied or not supplied to a whole area; it is not possible to provide each individual with a choice or obtain their consent. the principle of avoiding coercive interventions could be used to argue against adding anything to the water supply. however, the council does not accept that this should always be ruled out, especially if the substance being added may bring health benefits. the acceptability of any public health policy involving the water supply should be considered in relation to: (i) the balance of risks and benefits; (ii) the potential for alternatives that rank lower on the intervention ladder to achieve the same outcome; and (iii) the role of consent where there are potential harms. the council concluded that the most appropriate way of deciding whether to fluoridate the water supply is to rely on democratic decision-making procedures. these should be implemented at the local and regional, rather than national, level because the need for, and perception of, water fluoridation varies between areas. the idea of a 'nanny state' is often rejected, but the state has a duty to look after the health of everyone, and sometimes that means guiding or restricting people's choices. on the other hand, the state must consider a number of key principles when designing public health programmes, including mill's harm principle, caring for the vulnerable, autonomy and consent (although the latter two may be of lesser importance in public health than in clinical medicine). justification is required if any of these principles are to be infringed. evidence of the causes of ill health and the effectiveness of interventions should also be an integral part of policy-making in public health. existing bioethical frameworks are often not well suited to address the problems of public health. the nuffield council on bioethics tried to address this and its report provides a framework for thinking about, planning and implementing public health measures. none declared what is public health nanny or steward? the role of government in public health. london: king's fund health protection in the st century -understanding the burden of disease; preparing for the future. part infectious diseases. london: health protection agency tackling obesities: future choices. london: department of innovation universities and skills. available from: www.foresight.gov.uk/obesity/ .pdf the definition of alcohol-related deaths used by national statistics includes those causes regarded as most directly due to alcohol consumption national statistics. alcohol-related death rates almost double since the smoking epidemic in england. london: health development agency since the report was published, the uk government has imposed a % increase in all alcohol duty rates, and these will increase by % above the rate of inflation in future years london: british fluoridation society, uk public health association, british dental association and faculty of public health the nuffield council on bioethics has given permission for the findings of the report, 'public health: ethical issues' to be published in this article. key: cord- -s hljz authors: kang, lijun; ma, simeng; chen, min; yang, jun; wang, ying; li, ruiting; yao, lihua; bai, hanping; cai, zhongxiang; xiang yang, bing; hu, shaohua; zhang, kerang; wang, gaohua; ma, ci; liu, zhongchun title: impact on mental health and perceptions of psychological care among medical and nursing staff in wuhan during the novel coronavirus disease outbreak: a cross-sectional study date: - - journal: brain behav immun doi: . /j.bbi. . . sha: doc_id: cord_uid: s hljz the severe outbreak of novel coronavirus disease (covid- ), which was first reported in wuhan, would be expected to impact the mental health of local medical and nursing staff and thus lead them to seek help. however, those outcomes have yet to be established using epidemiological data. to explore the mental health status of medical and nursing staff and the efficacy, or lack thereof, of critically connecting psychological needs to receiving psychological care, we conducted a quantitative study. this is the first paper on the mental health of medical and nursing staff in wuhan. notably, among medical and nursing staff working in wuhan, . % had subthreshold mental health disturbances (mean phq- : . ), . % had mild disturbances (mean phq- : . ), . % had moderate disturbances (mean phq- : . ), and . % had severe disturbance (mean phq- : . ) in the immediate wake of the viral epidemic. the noted burden fell particularly heavily on young women. of all participants, . % had accessed psychological materials (such as books on mental health), . % had accessed psychological resources available through media (such as online push messages on mental health self-help coping methods), and . % had participated in counseling or psychotherapy. trends in levels of psychological distress and factors such as exposure to infected people and psychological assistance were identified. although staff accessed limited mental healthcare services, distressed staff nonetheless saw these services as important resources to alleviate acute mental health disturbances and improve their physical health perceptions. these findings emphasize the importance of being prepared to support frontline workers through mental health interventions at times of widespread crisis. in november , a novel coronavirus disease was first reported and then became widespread within wuhan, the capital city of hubei province of china (chan et al., ) . the disease rapidly psychological distress among medical staff appeared gradually: fear and anxiety appeared immediately and decreased in the early stages of the epidemic, but depression, psychophysiological symptoms and posttraumatic stress symptoms appeared later and lasted for a long time, leading to profound impacts (chong et al., ; wu et al., ) . being isolated, working in high-risk positions, and having contact with infected people are common causes of trauma (wu et al., ; maunder et al., ) . these factors may have impacted medical and nursing staff in wuhan, leading to mental health problems. the experience of medical staff responding to sars shows that the effects on medical staff members' mental health have not only shortterm but also long-term impacts and that the value of effective support and training is meaningful (maunder et al., ) . efficient and comprehensive actions should be taken in a timely fashion to protect the mental health of medical staff. the chinese government has made various efforts to reduce the pressure on medical and nursing staff in china, such as sending more medical and nursing staff to reduce work intensity, adopting strict infection control, providing personal protective equipment and offering practical guidance. based on previous responses to middle east respiratory syndrome (mers), medical staff tend to believe that such measures help protect their mental health (khalid et al., ) . in addition, to reduce the psychological damage of covid- among medical and nursing staff, mental health workers in wuhan are also taking action by establishing psychological intervention teams and providing a range of psychological services, including providing psychological brochures, counseling and psychotherapy (kang et al., ) . at the same time, television news and online media are also disseminating information about coping strategies for psychological self-help. however, evidence-based mental health services are preferable, and it is necessary to assess the quality of mental health services (aarons et al., ) . therefore, we explore the mental health status of medical and nursing staff in wuhan, the efficacy of the psychological care accessed, and their psychological care needs. we recruited doctors or nurses working in wuhan to participate in this survey from january , , to february , . this study was approved by the clinical research ethics committee of renmin hospital of wuhan university (wdry -k ). data were collected through wenjuanxing (www.wjx.cn) with an anonymous, selfrated questionnaire that was distributed to all workstations over the internet. all subjects provided informed consent electronically prior to registration. the informed consent page presented two options (yes/ no). only subjects who chose yes were taken to the questionnaire page, and subjects could quit the process at any time. the questionnaire consists of six parts: basic demographic data, mental health assessment, risks of direct and indirect exposure to covid- , mental healthcare services accessed, psychological needs, and self-perceived health status compared to that before the covid- outbreak. basic demographic data include occupation (doctor or nurse), gender (male or female), age (years), marital status (unmarried, married or divorced), educational level (undergraduate or lower, postgraduate or higher), technical title (primary, intermediate, or senior), and department (divided into high-exposure departments and non-highexposure departments according to the possibility of exposure to confirmed patients; high-exposure departments included the fever clinic, emergency department, general isolation ward, and intensive care unit). we used four scales to assess the mental health status of medical and nursing staff. the -item patient health questionnaire (phq- ), the item generalized anxiety disorder (gad- ), the -item insomnia severity index (isi) and the -item impact of event scale-revised (ies-r) were used to evaluate depression, anxiety, insomnia and distress, respectively. the phq- is a self-report measure used to assess the severity of depression, with the total scores categorized as follows: minimal/no depression ( - ), mild depression ( - ), moderate depression ( - ) , or severe depression ( - ) (kocalevent et al., ) . the gad- is a self-rated scale to evaluate the severity of anxiety and has good reliability and validity. the total scores are categorized as follows: minimal/no anxiety ( - ), mild anxiety ( - ), moderate anxiety ( - ), or severe anxiety ( - ) (löwe et al., ) . the isi is a measure of insomnia severity that has been shown to be valid and reliable. the total scores are categorized as follows: normal ( - ), subthreshold ( - ), moderate insomnia ( - ), or severe insomnia ( - ) (morin et al., ) . the ies-r is a self-report measure used to assess the response to a specific stressful life event and has extensive reliability and validity. the event used for this questionnaire was the occurrence of covid- . the total scores are categorized as follows: subclinical ( - ), mild distress ( - ), moderate distress ( - ), and severe distress ( - ) (daniel and weiss, ) . exposure to covid- was determined with the following questions asked to medical and nursing staff: have you been diagnosed with covid- ? do you manage patients diagnosed with covid- ? has your family been diagnosed with covid- ? have your friends been diagnosed? have your neighbors (people living in the same community who may or may not know each other) been diagnosed? then, participants were asked whether there was anyone living with them with suspected symptoms. the answer to each question was yes or no. the following question was used to determine which psychological services the subject had accessed. have you ever received the following services: psychological materials (leaflets, brochures and books provided by mental health workers and distributed to staff in the hospital), psychological resources available through media (psychological assistance methods and techniques provided by psychologists through online media or tv news or various online platforms) (supplementary material), and counseling or psychotherapy (including individual or group therapy)? three areas were assessed regarding the psychological services that participants hoped to receive in the future: what kind of mental health service content were participants most interested in (including knowledge of psychology, ways to alleviate their own psychological reactions, ways to help others alleviate their psychological reactions, or ways to seek help from psychologists or psychiatrists); what kind of resources were most anticipated (including psychological materials, psychological resources available through media, group psychotherapy, individual counseling and psychotherapy, uninterested or other); and who participants would prefer to receive care from (including psychologists or psychiatrists, family or relatives, friends or colleagues, do not need help, or other). health status was determined by asking participants to compare their current health status to their health status before the outbreak of covid- : how do you perceive your current health status compared to your health status before the outbreak? (answer options included l. kang, et al. brain, behavior, and immunity xxx (xxxx) xxx-xxx getting better, almost unchanged, worse, or much worse). data analysis was performed using ibm spss statistics for windows (version . ) and mplus (version . ). descriptive analysis was used to describe the general data and currently accessed psychological services. for count data, frequencies and percentages were used. the k-means clustering method was used to cluster the phq- , gad- , isi, and ies-r scores (ball, ) . with the euclidean square root distance as the measurement index, the patients were divided into groups by the ward method. according to this grouping, exposure to covid- and the current state of mental healthcare services were compared. the chisquare test was used to compare the data for different categorical variables. a structural equation model (sem) was constructed via mplus to explore the relationship among the four components, namely, exposure, accessed mental healthcare services, mental health status (phq- , gad- , isi, and ies-r scores) and self-perceived health status compared to that before the covid- outbreak. the estimation method used weighted least squares with mean and variance adjustment test statistics (distefano and morgan, ) . we used a monte carlo method with guided resamplings to construct a confidence interval for the estimation effect (bauer et al., ) . in sem, several criteria, such as root mean square error of approximation (rmsea) values < . and comparative fit index (cfi) and tucker-lewis index (tli) values > . , indicate acceptable models (hu and bentler, ) . p values < . indicated that a difference was statistically significant. in total, participants, including ( . %) doctors and ( . %) nurses, completed the survey. a total of . % worked in highrisk departments. the participants tended to be female ( . %), be aged to years ( . %), be married ( . %), have an educational level of undergraduate or less ( %), and have a junior technical title ( . %), as shown in table . of all participants, . % had received psychological materials, . % had obtained psychological resources available through media, and . % had participated in group psychological counseling, as shown in table . according to the phq- , gad- , isi, and ies-r scores, the participants were divided into groups. thirty-six percent of the medical staff had subthreshold mental health disturbances (mean phq- : . , gad- : . , isi: . , ies-r: . ), . % had mild disturbances (mean phq- : . , gad- : . , isi: . , ies-r: . ), . % had moderate disturbances (mean phq- : . , gad- : . , isi: . , ies-r: . ), and . % had severe disturbances (mean phq- : . , gad- : . , isi: . , ies-r: . ). there were significant differences in the phq- , gad- , isi, and ies-r scores among the four groups, as shown in table . in contrast, there were no significant differences in demographic data among the four groups, as shown in table . for medical and nursing staff, exposure to people around them who were infected varied among the different groups. the group with subthreshold mental health disturbances had contact with fewer people confirmed or suspected to be infected with the virus. each group with a higher level of distress had a more extensive scope of exposure. there were also significant differences in mental healthcare services among the four groups; those with severe disturbances had accessed fewer psychological materials and psychological resources available through media. in addition, the perception of current health status compared to that before the outbreak of covid- was also different among the groups, as shown in table . we established an sem of the associations between the four areas. first, exposure as a risk factor for mental health, including the confirmed diagnosis of patients, the participants' themselves, family, friends, colleagues, neighbors, and coresidents with suspected symptoms, was analyzed in the previous step. second, the mental healthcare services accessed consisted of psychological materials and psychological resources available through media. third, mental health consisted of the phq- , gad- , isi, and ies-r scores. the fourth area was the subjective feelings of the staff regarding whether their physical conditions were worse than before the epidemic. the chi-square test of model fit yielded a value of . , with degrees of freedom = , pvalue = . , rmsea = . , cfi = . , and tli = . , indicating a good fit. the results showed that the risk factors of exposure affected mental health and that mental health affected subjective physical health perceptions. mental healthcare services only partially l. kang, et al. brain, behavior, and immunity xxx (xxxx) xxx-xxx mediated the relationship between exposure risks and mental health. mental healthcare services regulated the relationship between the risk of exposure and subjective physical health perceptions by affecting mental health. the results are shown in fig. and table . . . psychological care needs of medical and nursing staff in terms of the content of interest, namely, psychological care, medical and nursing staff with subthreshold disturbances most wanted to obtain skills to help alleviate others' psychological distress, whereas other medical and nursing staff most wanted to obtain self-help skills. medical and nursing staff with higher levels of mental health problems were more interested in skills for self-rescue and showed more urgent desires to seek help from psychotherapists and psychiatrists. medical and nursing staff differed in terms of how they wanted to obtain services based on their levels of mental health problems. medical and nursing staff with subthreshold and mild disturbances preferred to obtain such services from media sources, while staff with heavier burdens wanted to seek services directly from professionals. apart from medical and nursing staff with subthreshold disturbances who did not think they needed help from others, the other workers saw a greater need to obtain help from professionals than from close family and friends. the results are shown in table . this is the first mental health investigation in the wake of the coronavirus epidemic in wuhan, china that aims, in part, to explore the demand for mental healthcare services in this context. when cities are struck by deadly, large-scale disasters of various types, the characteristics of mental health problems that arise can differ across different periods (shioyama et al., ) . we therefore chose to survey a set of people (health care providers) in the discrete window of time soon after the initiation of a chaotic event (the outbreak of coronavirus infections). to conduct a comprehensive analysis, we used multiple different scales to evaluate the mental health of medical staff. our study has revealed the limits in the availability of mental healthcare services provided by psychologists and psychiatrists and thus the limits in access points for psychological care for distressed individuals, including less personalized sources of support such as publication-style psychological materials and psychological resources available from media. these latter methods can nonetheless contribute positively to alleviating mental health problems and physical discomfort caused by risk factors such as the exposure of close contacts to covid- . such exposure is known to be mentally injurious in epidemic settings: when the sars epidemic hit, not only did the direct exposure of the work environment affect the mental health of medical staff, but the infection of friends or close relatives generated psychological trauma (wu et al., ) . we found that subthreshold and mild mental health disturbances accounted for a large proportion of disturbances. people with such levels of disturbances may be more likely than those with more severe disturbances to take action and be motivated to learn the necessary skills and to adapt in productive ways to respond to diverse challenges. these skills have been shown in previous retrospective studies to be protective for later mental health (maunder et al., ) . in addition, we note that people with subthreshold and mild mental health disturbances want to find ways to better help others, which is beneficial for health care teams. in terms of physiology, positive coping has been seen to increase immune function when victimized subjects report high mental demands, leading to a better state of response (sakami et al., ) . however, there are negative consequences of stimulation caused by pressure, as acute psychological stress is known to activate the sympathetic adrenal medulla system and hypothalamus-pituitary adrenal axis, and this two-component stress response impacts physical and mental health and has disease consequences (turner et al., ) . in summary, continuous mental healthcare services are necessary even for subthreshold and mild psychological reactions during this epidemic to attenuate the possibility of escalating complications. multiple features were found for the group of untreated clinical l. kang, et al. brain, behavior, and immunity xxx (xxxx) fig. . in this model, the solid line represents a significant relationship between the two, while the dotted line represents the relationship is not significant. kang, et al. brain, behavior, and immunity xxx (xxxx) xxx-xxx personnel who had serious psychological problems. first, compared to less severely affected groups, they had accessed fewer printed psychological advice materials (e.g., office brochures) and had accessed less psychological guidance publicized through digital media. second, they were more likely to desire personalized, one-on-one counseling as a therapy option. one might speculate a cause-and-effect relationship wherein more frequent exposure of the other groups to the noted materials in some way protected them from reaching the most severely impacted category, but our cross-sectional results are, by nature, correlational. this study limitation does not detract, however, from the importance of widely implementing prevention and monitoring strategies; mildly to moderately impacted personnel expressed interest in having access to psychological guidance materials, which provides evidence of the importance of prevention strategies. the number of people suffering from mental health impacts after a major event is often greater than the number of people who are physically injured, and mental health effects may last longer. nonetheless, mental health attracts far fewer personnel for planning and resources (allsopp et al., ) . thus, the lancet global mental health commission's observation that the use of nonprofessionals and digital technologies can provide a range of mental health interventions may indicate an opportunity (patel et al., ) . our data are consistent with a model in which psychological advice and guidance in print resources and disseminated in the media can provide a level of protection for medical and nursing staff, improving mental health by reducing the stress impacts caused by high risk of infection. clearly, there is a role, nonetheless, for therapist-driven sessions, as previous research showed that a convenient group course intervention for doctors reduced depersonalization, improved views on the meaning of work, and achieved sustained results (west et al., ) . we anticipate similar benefit for covid- staff in wuhan based on our findings contained herein. interestingly, previous studies on medical staff and other infectious agents have repeatedly emphasized that mental health impacts are related to department and occupation (hawryluck et al., ; wu et al., ) . health care workers with professional knowledge about differences in the relative exposure patterns and transmission of different infectious diseases could gain some degree of comfort and control over their situations (chowell et al., ) . for example, over the decades, although hepatitis viruses and hiv have often caused lethal infections, radiologists, pathologists and nurses knew that their risk of exposure was low as long as they exercised caution in their contact with bodily fluids. the situation has been different in wuhan due to the pernicious characteristics of covid- . many infected individuals exhibit minimal or no symptoms while contagious, for example, early in the course of infection (bai et al., ) . these individuals may thus visit a variety of different hospital departments in an infectious but asymptomatic state, unknowingly spreading the disease directly through aerosolized droplets or indirectly through skin contact with handled surfaces. these features of the infectivity of coronavirus involve a substantial risk of exposure for medical workers, regardless of their hospital department, job title or building location; thus, any workerwhether doctor or nurse, specialist or generalistis at substantial risk. the resultant stress due to concerns about infection risk thus indiscriminately affects large numbers of personnel. there is a need to better recognize mental health needs as an important component of mobilizing a large-scale therapeutic response to sudden city-scale crisis scenarios. a large rapid response team in crisis situations should include mental healthcare workers. local medical and nursing staff at the epicenter of a crisis are pivotal to the overall response, and care for these caregiverswhether through face-to-face counseling or comparable support through digital platforms such as cell phone interfacesis essential in efforts to extend their immediate efficiency and to better protect their mental health in the long term. our research also has some limitations. first, compared with faceto-face interviews, self-reporting has certain limitations. second, the study is cross-sectional and does not track the efficacy of psychological services. due to changes in posttraumatic mental health, dynamic observation is necessary. a randomized prospective study could better determine correlation and causation. third, a larger sample size is needed to verify the results. in summary, the results demonstrate that a strikingly large portion of health care providers in virus-plagued wuhan are suffering from mental health disturbances. they would benefit from greater availability of personalized mental health care from psychotherapists and psychiatrists, wherein different mental health groups could focus on providing specialized mental healthcare services. among the steps needed to better prepare for future infectious disease outbreaks would be a greater investment in the mental health tools in society's medical arsenal to protect and care for future medical and nursing staff who find themselves unexpectedly on the dangerous front lines of disease response. the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work 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of school children after the great hanshin-awaji earthquake: ii. longitudinal analysis psychological stress reactivity and future health and disease outcomes: a systematic review of prospective evidence intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial second-meeting-of-the-international-health-regulations-( )-emergency-committee-regarding-the-outbreak the psychological impact of the sars epidemic on hospital employees in china: exposure, risk perception, and altruistic acceptance of risk this work was supported by grants from the national key r&d program of china (grant numbers: yfc ) and the national natural science foundation of china (grant numbers: ). wrote and contributed to the writing of the manuscript: zl, cm, lk and sm. supplementary data to this article can be found online at https:// doi.org/ . /j.bbi. . . . key: cord- -egq d i authors: brown, teneille r title: when the wrong people are immune date: - - journal: j law biosci doi: . /jlb/lsaa sha: doc_id: cord_uid: egq d i after a disaster such as the covid- pandemic, there will be an irresistible desire to blame others. despite documented failures in the federal government’s response to the pandemic, injured individuals will not be able to hold it accountable due to the broad application of governmental immunity. congress and state governments have provided targeted immunity to various device manufacturers and emergency volunteers. however, the one group with huge targets on their backs are individual physicians, who are often making impossible choices that are reasonable at the time, but might not appear reasonable to a jury after the fact, and with the bias of hindsight. recognizing that the potential for liability might cause undue psychological stress on health care providers, this essay argues for statutory immunity that protects them from rationing and other health care decisions that are made in good faith, and that are in compliance with documented state, institutional, or professional pandemic-response guidelines. after a disaster such as the covid- pandemic, there will be an irresistible desire to blame others. people will attribute intentionality to actions that were purely accidental and deem people careless for failing to prevent unforeseeable harms. even assessments of causation will be influenced by whether we think someone acted selfishly. we will blame our neighbors for going to the grocery store without wearing masks. we will blame those who hoarded pallets of toilet paper. we will blame the chinese. we will blame the broken health care system. we will blame the physician who ignored our appeals for a ventilator for our dad. after so much death, we may even blame god. the post-mortems will frustratingly attempt to identify the cause of this catastrophe, as if there were that simple. hopefully, in the midst of this powerful need to blame, we will not forget who the primary target of our outrage should be-our federal executive branch. we are only midway through the crisis, and it is already quite clear that the president's response has been nothing short of reckless. he has made a number of notable missteps that may have exacerbated the death toll; to make this plain i will canvass just a few of them here. rather than immediately using the defense production act to order companies to produce needed tests and medical supplies, the president downplayed the seriousness of the virus. the failure to immediately develop testing capacity led directly to an inability to conduct effective contact tracing. when tests were initially developed by the centers for disease control (cdc), they were determined to be contaminated due to sloppy laboratory procedures. other laboratories began developing reliable tests for the virus, but the cdc wanted to be the sole source, and federal drug administration (fda) regulations that required emergency use authorization were slow to be approved. these initial testing failures allowed the virus to quietly spread among the many who are asymptomatic. due to the termination of the senior director for global health security and biodefense in , there has not been a coordinated, authoritative federal response. doctors have complained that they are not looking to the cdc for trustworthy data, and are instead relying on more informal networks and non-governmental publications. the president also frequently misstated the availability of testing, leading people to bombard their local health care facilities for tests that they did not have. regarding treatment, the president later claimed that the fda had approved a -game-changer‖ drug (hydroxychloroquine), despite the fda later correcting that the drug was still being tested for zolan kanno-youngs and ana swanson, wartime production law has been used routinely, but not with coronavirus, ny times, march , , available online at https://www.nytimes.com/ / / /us/politics/coronavirusdefense-production-act.html sheila kaplan, c.d.c. labs were contaminated, delaying coronavirus testing, officials say, ny times, april , , available online at https://www.nytimes.com/ / / /health/cdc-coronavirus-lab-contamination-testing.html bob ortega, scott bronstein, curt devine, and drew griffin, how the government delayed coronavirus testing, cnn, april , , available online at https://www.cnn.com/ / / /politics/coronavirus-testing-cdc-fda-red-tape-invs/index.html david frum, this is trump's fault, april , , the atlantic, available online at https://www.theatlantic.com/ideas/archive/ / /americans-are-paying-the-price-for-trumps-failures/ / liz alesse, did trump try to cut the cdc's budget as democrats claim?: analysis, abc news, feb. , , available online at https://abcnews.go.com/politics/trump-cut-cdcs-budget-democrats-claim-analysis/story?id= (-the president fired the pandemic specialist in this country two years ago,‖ former nyc mayor michael bloomberg said. he then claimed he had -total‖ authority to mandate a premature reopening of the state economies, which went against his health expert's advice, and notably the u.s. constitution. when armed individuals in michigan, minnesota, and virginia protested the continued social distancing orders and closure of non-essential businesses, he appeared to encourage insurrection, tweeting -liberate virginia, and save your great nd amendment. it is under siege!‖ lamentably, despite being the primary mistake-maker here, the federal government itself will enjoy broad immunity, and will be essentially protected from any tort liability related to its covid- response. the concept of sovereign immunity derives from english law, where it was assumed that -the king can do no wrong.‖ since the thirteenth century, the english monarchy could not be sued unless it agreed to waive immunity. the concept was somewhat clumsily borrowed and applied to our federal and state governments in the united states, despite our emphatic rejection of an unaccountable crown. there are principled justifications to federal sovereign immunity. namely, the separation of powers supports executive agency policy decisions being protected from being secondguessed by the courts. immunity may also be defended on instrumental grounds, as the government's motive is to protect the general welfare, and not to maximize profits and avoid liability. while these claims have merit, there are even more powerful counterarguments, that ( ) (holding that a state's invocation of sovereign immunity when the petitioner alleges colorable fourth amendment claims violated the supremacy clause of the constitution). section (a) of the public health service act -grants absolute immunity to phs officers and employees for actions arising out of the performance of medical or related functions within the scope of their employment by barring all actions against them for such conduct.‖ see, hui v. castaneda, u.s. , ( ); in some cases, even a bivens remedy is precluded, such as when public health service officers or employers are sued under the public service act. discretionary duty that was breached, she would likely still lose due to the common law -public duty‖ doctrine. the public duty doctrine holds that because governments owe a duty of care to every citizen, they do not owe a duty to any one particular citizen. both state and federal courts have interpreted this to mean that government officials such as emergency responders cannot be sued in tort when they fail to perform their duties, such as sending aid in response to a call. if there was no direct contact or assurance of aid to a particular individual, then there was no duty for the dispatcher, for example, to perform her functions. the public duty doctrine has astonishing consequences, and often insulates the police, emergency responders, and many state agencies from being accountable for their negligence or wrongdoing. there is nothing to suspend this doctrine during public health emergencies, and in fact, the emergency situation is likely to expand its application. to summarize, as a result of both the discretionary function exception and the public duty doctrine, we can expect that injured individuals will not be able to seek adequate legal recourse from our federal or state governments for their failure to respond appropriately to the pandemic. thus, one of the only ways the federal government will be accountable for wrongdoing will be if the president suffers political consequences in the next election. relying solely on political accountability is worrisome, however. for one, political accountability has been significantly watered down in the last decade, in part due to almost unlimited corporate money in political campaigns, and the distortions of representation in the electoral college . this is also fueled by information asymmetry; we cannot assume that the electorate has the bandwidth to pay attention to the many conflicting news stories and evidence of political wrongdoing. political accountability requires a great deal of focus and time that many voters simply do not have. this may be in part why it has taken considerable presidential mismanagement to move the needle at all. the president's approval ratings were at an all-time high despite some major mistakes in his response to covid- . they only very recently have started to decline. importantly, however, even if the president suffers significant political consequences from his mishandling of the pandemic, almost none of this will trickle down to the agency executives or career bureaucrats who did his bidding. while political accountability in theory provides a check on shoddy political decision-making, it provides a very weak check on agencies. this is sometimes by design . perhaps most important of all, political accountability, even if perfect, does absolutely nothing to compensate those who were individually injured by executive recklessness. the need to compensate injured parties provides the strongest basis for removing immunity. if government is responsibly conducting their risk benefit analyses, there will not be many plaintiffs seeking compensation. but the complete lack of a remedy for carelessly inflicting personal harm flies in the face of our democratic principles of government. april , , available online at https://www.usnews.com/news/best-states/utah/articles/ - - /utahbuys-malaria-drugs-touted-by-trump-panned-by-doctors the utah statute places the burden on the individual patients, by suggesting that so long as they provide informed consent, immunity is appropriate for prescribing unapproved medications. this appears to be linked with the -right to try‖ movement. however, there are sound reasons why we do not permit individuals to be treated with medications that are not proved as safe or effective, even if an individual's cost-benefit analysis skews toward welcoming greater risk, and we certainly should not absolve providers from liability when their off-label use is negligent. see, abigail all. for better access to developmental drugs v. von eschenbach, u.s. app. d.c. , ( ) on march th , the president signed the -coronavirus aid, relief, and economic security act‖ (cares act) into law. the act provides broad liability immunity for companies that manufacture respiratory protective devices. it also preempts state law to immunize volunteer health care workers from tort liability for negligence in actions or omissions in the course of providing volunteer health care services related to the constitutionality of the latter preemption will no doubt be challenged, as the states typically regulate intrastate tort liability. indeed, most states already immunize volunteer health care workers for carelessness when they respond to an emergency. even so, the immunity provisions in the prep and cares acts speak to congressional recognition that the fear of liability might stymie our pandemic response, both at the state and federal levels. of all of the predictable defendants to be sued after a pandemic, there is one group that is glaringly absent from this list: non-volunteer health care workers. even when they work for a state hospital, nurses and physicians are typically not protected under the state's governmental immunity, as they -exercised medical judgment, regardless of whether it related to policy decision.‖ as parties will be looking for someone to hold accountable for the terrible outcomes other protocols prioritize short-term clinical factors, but then suggest using life-cycle considerations as a tiebreaker, with priority going to younger patients. there is a robust debate occurring about the ethics and potential illegal discriminatory impacts of these policies. the purpose of this article is not to advocate for a particular framework, but rather to provide legal immunity for physicians who make decisions in compliance with a documented policy. if an institution has no documented policy, and leaves rationing up to the individual decision, they expose both the physician and the institution to legal liability from discriminatory or substandard decisions. implementing a policy that complies with anti-discrimination law is prudent in these situations to reduce this risk. there are only so many physicians and nurses, and only so many beds. the possibility of a medical malpractice lawsuit will do nothing to prevent the need to ration. if there is only icu bed available, and ten patients vying for it, the possibility of ex post tort liability will not instantly create nine more beds. perhaps if the government could be accountable for this failure, more beds and ventilators could be produced or reallocated from regions that are not as hard hit by covid- . but the physicians on the frontlines cannot be expected to create additional resources while fighting this pandemic. the normal incentives of deterrence will thus not work to create better rationing or to remove the need for rationing. indeed, the possibility of liability will only make the necessary rationing more discriminatory and unfair, as physicians cater to the loudest, wealthiest, or most educated patients who fight the hardest, and who seem most likely to there will be many institutional policies related to covid- that will expose individual physicians to liability, and these instances may be even more common than the need to ration scarce resources. physicians are being instructed by their states, professional associations, and in addition to taking extra precautions during procedures, physicians are also being instructed by their employers to reschedule or cancel cancer, heart, and lung interventions that they think can wait several weeks. this is done both to reduce the risk of the immune- , ( ) . cath lab digest, data shows reduction in u.s. heart attack activations during covid- pandemic, april , , available online https://www.cathlabdigest.com/content/data-shows-reduction-us-heart-attack-activations-during-covid- pandemic weeks before having a tumor resected or fluid drained. it is possible that patients who had a delayed diagnosis or treatment might sue the physicians who made this call, if it turns out not to have been clinically appropriate for them. while these decisions might all be perfectly reasonable during a pandemic, the fear (or reality) of having to defend these utilitarian decisions in court might add undue stress on the physicians who are doing their best to follow state or institutional policy. the value of immunity comes not just from rejecting the second-guessing of emergency decisions that were thrust upon an overwhelmed industry. there is also considerable value in giving physicians peace of mind that the forced choice between two terrible possibilities will not later be penalized in court. during normal times, emotions run high when a loved one is denied medical treatment or injured during a procedure. the resulting break-down of communication may lead to a lawsuit, as many people will be unhappy with how resources were rationed or decisions made. under ordinary circumstances, a physician may be liable for a clinical judgment that could foreseeably cause a patient's death. however, these are not ordinary circumstances, and health care providers are being asked to make impossible decisions that may aid our ability to respond to covid- , but which might increase the risk to individual patients. there is often no third option that avoids putting a particular patient at risk to help others. immunity is appropriate in these situations where the providers' decisions are objectively reasonable and defensible ex ante, and for which there would be great psychological value in removing the possibility of suit. while it might seem unlikely that many families will sue, as they should appreciate that the extenuating circumstances of the pandemic, not all families will be so understanding or reasonable. to be sure, there may be greater distrust of physician decision-making and increased incentives to sue in the wake of this pandemic, as people are more isolated and anxious, and may be suffering from severe economic instability. additionally, as the social distancing measures cities and states have adopted to -flatten the curve‖ are working, the lack of a big surge in infections as was seen in new york might anger those patients who assume that the precautionary measures were not necessary. given this, we can expect that some number of families will claim that a physician who denied their family member treatment, or performed a procedure differently due to covid- precautions, caused them a compensable injury. depending on the circumstances, a judge and jury may agree. causation and breach are not discoverable facts of nature, but rather are morally laden and susceptible to hindsight bias. hindsight bias could be particularly severe here. cases would not be litigated until long after the chaos of the pandemic has subsided, which might permit juries to forget just how extenuating the circumstances appeared to be ex ante. therefore, even if physicians were doing their best at the time to fairly allocate resources and follow institutional policies, a jury could find them liable for making an intolerable choice that caused harm. indeed, even if the possibility of an award is remote, the very prospect of this possibility may create unfair and paralyzing fear for physicians, who as a group already overestimate the risk of being sued. this article advocates for removing the possibility of a medical malpractice claim for individual physicians and independent health care providers, when they are complying with published state, professional, or institutional covid- policies in good faith. ideally, as part of any emergency response packages that are passed, legislatures should either develop, or require hospitals to develop, protocols for rationing ventilators, ecmo machines, icu beds, and personnel. it would be best if the policy were mandatory at the state level, to encourage cooperation between health care facilities. further, and more to the point, when enacting these statutes, legislatures should incorporate tort immunity for health care workers who comply with covid- treatment protocols in good faith. in the absence of a state directive, this article also advocates for immunity for individual physicians when they comply with a recognized professional organization's guidance related to covid- , or institutional policies related to their covid- response. this is not merely to limit the liability of a powerful group. it is to recognize the unbearable situation that health care workers face during a pandemic, which is not at all of their own creation. it is also to recognize that certain decisions might appear unreasonable ex post, but they were not unreasonable ex ante. health care providers are under an inordinate amount of stress as they expose themselves to a serious or deadly disease, often while working incredibly long hours. the extenuating circumstances of a pandemic necessitate immunity for physicians who are doing their best to bravely make critical decisions, with imperfect information, . one way to do this would be to require gross negligence or more before a physician could be liable for refusing someone hospital resources, rather than immunizing them from negligence only when their conduct was reviewed as -reasonable.‖ the reasonability review embedded in medical futility statutes guts them of their immunity protection and removes the desired peace of mind they are intended to bestow. their end-of-life plans, to discourage only certain groups from refusing life-sustaining treatment, should emphatically not be immunized from tort liability. further, given our experience with medical futility statutes, it would be prudent to afford clearer protection from suit than what the medical futility statutes typically provide. for examples specifically targeted at providing physicians immunity in response to a pandemic, we can also look to laws in effect in maryland and new york. at least wo states have passed targeted immunity laws, which would protect paid health -that all physicians, physician assistants, specialist assistants, nurse practitioners, licensed registered professional nurses and licensed practical nurses shall be immune from civil liability for any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the state's response to the covid- outbreak.‖ the immunity does not attach if the injury was caused by gross negligence, but it is otherwise much broader than the maryland statute. for one, it provides immunity for actions that are not performed in accordance with any state public health directive, but are rather just -in support‖ of the state's response. it also provides for immunity in non-emergency situations. a that a physician acted with an intent to kill, then a criminal action seems completely appropriate. a civil action also seems appropriate, if unlikely, where a plaintiff can make out a prima facie claim that the physician acted with gross negligence or worse. immunity should only cover negligence claims to strike the right balance between protecting physicians and compensating plaintiffs who were clearly wronged. denying actions for criminal, or grossly negligent actions provides too much immunity and has the potential to absolve, or even encourage, bad actors. remain liable for policy decisions they implement, this might be unsatisfactory as it is harder for a plaintiff to prove that a policy, as opposed to an individual physician's decision, violated the standard of care. this is a risk, but one that seems justified to ensure that immunity is not overly broad to protect decisions that might be unreasonable, even given the pandemic. ideally, the cost of making difficult decisions during a pandemic should not fall on individual patients. those who are injured by others' carelessness should have some legal resource when they are wronged. but our powerful desire to correct a potential injustice, and to shift the cost elsewhere, should not come at the expense of holding individual health care workers responsible for decisions that were reasonable ex ante. there is great risk of hindsight bias, where juries might forget the very real and conflicting pressures physicians were facing, especially if communities do not experience the overwhelming surges that were predicted. the summary judgment standard of -no reasonable juror could find breach‖ provides a good guide for tailoring immunity to those situations where it can do the most good and the least harm. immunity laws recognize that even if a plaintiff is properly denied recovery at the summary judgment stage, getting to this point imposes considerable emotional and financial costs on the individual physicians. in addition to having to review case files, be deposed, and physicians did not create this pandemic situation. while they are intimately involved in its mitigation, these heroic efforts should not expose them to unnecessary malpractice liability, merely because government immunity makes them the last target standing. our state and federal governments should be accountable, as public health agencies and government figures have a moral and legal duty to protect their citizens and prepare for health emergencies. there is a possibility that the federal government could waive immunity for personal injury related to its response to the pandemic. following the threat of a previous h n pandemic, congress passed the swine flu act, which created a private right of action against the u.s. from injuries resulting from swine flu inoculation. or, the government could set up a compensation fund for families adversely affected by rationing decisions. while removing immunity-where the government acted recklessly or in ways that abused its discretion-would be a sensible way to provide accountability, it also seems politically quite unlikely. we can hope for some political recourse, as the executives and their agencies that failed to prepare or respond may be removed from office. however, for the reasons described above, this is an enormously imperfect check. crucially, it provides no remedy for the parties who are injured by carelessness or wrongdoing. if a corporation develops a defective product that injures we are learning many lessons from this pandemic, some welcome and some not. one lesson we might take away from this is the need for better remedies against government officials when they completely fail to perform their public duties. the time has come to pass legislation that more significantly waives immunity in line with our democratic ideals. now, more than ever, we must fight the dangerous notion that our leaders are kings. trump endorses ending coronavirus social distancing soon, against health experts' advice extremists see a call to arms, nbc news shifting the balance of power? the supreme court, federalism, and state sovereign immunity: against sovereign immunity keeping the arms in touch: taking political accountability seriously in the eleventh amendment arm-of-the-state doctrine a theory of governmental damages liability: torts, constitutional torts, and takings this author also supports immunity on corrective justice grounds, as -the government passes its legal costs along to the taxpayers this system is doomed': doctors, nurses sound off in nbc news coronavirus survey characteristics of health care personnel with covid- -united states healthcare workers who have died of covid- the psychological impacts of treating covid- patients have proved to be devastatingly real. see, eric levenson, stress on health care workers is creating 'second victims' in the coronavirus pandemic care of the critically ill and injured during pandemics and disasters: chest consensus statement, chest e s- s ( ) policies vary, and could advocate for prioritization based on different grounds, such as need, equity, or protecting the most vulnerable. see, james tabery, et al., ethics of triage in the event of an influenza pandemic, disaster med public health preparedness a framework for rationing ventilators and critical care beds during the covid cdphe all hazards internal emergency response and recovery plan: annex b: colorado crisis standards of care plan this proposal does nothing to alter liability under federal statutes such as us section , or anti-discrimination law, such as that contained in section of the affordable care act liability claims can and do flow from emergencies, illustrated by ongoing civil litigation against dr salt lake county mayor jenny wilson says social distancing measures are working in flattening the curve, abc news flattened the curve' of covid- cases, mayor lori lightfoot says, wbez news proximate cause explained: an essay in experimental jurisprudence, forthcoming in the university of chicago law review physicians' perceptions of the risk of being sued governor cuomo issued an order revising an education law to provide a policy that permitted categorical age discrimination would violate section of the affordable care act medical futility states: no safe harbor to unilaterally refuse life-sustaining treatment, tenn protect the doctors and nurses who are protecting us while immunity statutes provide a clear signal to plaintiffs' attorneys, especially the majority of them working on a contingency fee basis, that they are quite likely to lose and not be paid, there may still be some who fail to internalize that risk and sue. there does not seem to be a principled way to remove this risk legal preparedness: care of the critically ill and injured during pandemics and disasters: chest consensus statement, chest e s key: cord- -fa niz authors: kwon, chan-young; kwak, hui-yong; kim, jong woo title: using mind–body modalities via telemedicine during the covid- crisis: cases in the republic of korea date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: fa niz the coronavirus disease (covid- ) pandemic affected the world, and its deleterious effects on human domestic life, society, economics, and especially on human mental health are expected to continue. mental health experts highlighted health issues this pandemic may cause, such as depression, anxiety, obsessive compulsive disorder, and post-traumatic stress disorder. mind–body intervention, such as mindfulness meditation, has accumulated sufficient empirical evidence supporting the efficacy in improving human mental health states and the use for this purpose has been increasing. notably, some of these interventions have already been tried in the form of telemedicine or ehealth. korea, located adjacent to china, was exposed to covid- from a relatively early stage, and today it is evaluated to have been successful in controlling this disease. “the covid- telemedicine center of korean medicine” has treated more than % of the confirmed covid- patients in korea with telemedicine since march . the center used telemedicine and mind–body modalities (including mindfulness meditation) to improve the mental health of patients diagnosed with covid- . in this paper, the telemedicine manual is introduced to provide insights into the development of mental health interventions for covid- and other large-scale disasters in the upcoming new-normal era. the coronavirus disease (covid- ) was first reported as "a cluster of cases of pneumonia" on december at the wuhan municipal health commission in china. on january , world health organization (who) director-general declared the novel coronavirus outbreak as a public health emergency of international concern (pheic) and eventually declared covid- as a pandemic on march [ ] . the optimal treatment for infection of this coronavirus, which has the official name of severe acute respiratory syndrome coronavirus (sars-cov- ), has not yet been established, and symptomatic treatment and supportive treatment are mainly performed [ ] . therefore, front-line health care providers and health authorities around the world had great difficulties during this pandemic. antiviral agents approved for treatment of common influenza, such as favilavir, are being tried on covid- patients, but the established clinical evidence is lacking, and clinical trials of the first vaccine against sars-cov- are unlikely to be conducted this year [ ] . korea, an adjacent country to china, was affected by covid- from a relatively early stage, and today it is evaluated to have been successful in extinguishing covid- although strategies to cope with the physical health impact of covid- were gradually explored, the impact of this pandemic on human families, society, economics, and especially on the mental health of individuals, are expected to continue [ ] [ ] [ ] . first, the impact of the pandemic on mental health started with the ambiguity and anxiety that arose from the absence of a cure or vaccine for sars-cov- infection, and the rapid spread of infection brought panic to the public with limited quarantine resources [ ] . many people had to watch themselves or beloved family and friends suffer from the disease. moreover, many people lost the freedom of everyday life due to social distancing and/or quarantine. furthermore, some argue individuals must prepare for the "new-normal" [ ] . in addition to the negative psychological effects of disease-related factors, the worldwide economic contraction caused by this epidemic is considered a major threat to the survival of the general public from an economic perspective [ ] . one encouraging factor is the use of telemedicine during the pandemic [ ] . since covid- makes it impossible for patients with various diseases to visit a clinic directly for face-to-face care due to concerns over the spread of the virus, several healthcare providers are looking for ways to use telemedicine instead [ ] . mental health management is one of the areas that is making rapid progress in the field of telemedicine. mindfulness, a type of mind-body modality, may be defined as one being non-judgmentally aware in every moment. in the field of mental health care, the combination of telemedicine or e-health has been tried along with mindfulness [ ] . korea has a dualized medical system called western medicine and korean medicine (km) and "the covid- telemedicine center of km" has treated more than % of confirmed covid- patients in korea with telemedicine since march ( figure ) . initially, the telemedicine center was established by the association of korean medicine (akom), a representative organization of all km doctors established in the early s, at daegu korean medicine hospital, daegu, korea, where the number of covid- patients increased rapidly. after the outbreak was controlled in daegu and gyeongbuk, akom set up a second covid- telemedicine center of km in seoul. the center uses herbal medicine (mainly qing-fei-pai-du-tang) with established protocols based on multidisciplinary expert discussions and empirical evidence [ ] , and the center also used telemedicine in conjunction with mind-body modalities (including mindfulness meditation) to improve the mental health of covid- patients in korea. the aim of this paper is to introduce the km doctor's mental health instruction manual in telemedicine for covid- and to provide insights although strategies to cope with the physical health impact of covid- were gradually explored, the impact of this pandemic on human families, society, economics, and especially on the mental health of individuals, are expected to continue [ ] [ ] [ ] . first, the impact of the pandemic on mental health started with the ambiguity and anxiety that arose from the absence of a cure or vaccine for sars-cov- infection, and the rapid spread of infection brought panic to the public with limited quarantine resources [ ] . many people had to watch themselves or beloved family and friends suffer from the disease. moreover, many people lost the freedom of everyday life due to social distancing and/or quarantine. furthermore, some argue individuals must prepare for the "new-normal" [ ] . in addition to the negative psychological effects of disease-related factors, the worldwide economic contraction caused by this epidemic is considered a major threat to the survival of the general public from an economic perspective [ ] . one encouraging factor is the use of telemedicine during the pandemic [ ] . since covid- makes it impossible for patients with various diseases to visit a clinic directly for face-to-face care due to concerns over the spread of the virus, several healthcare providers are looking for ways to use telemedicine instead [ ] . mental health management is one of the areas that is making rapid progress in the field of telemedicine. mindfulness, a type of mind-body modality, may be defined as one being non-judgmentally aware in every moment. in the field of mental health care, the combination of telemedicine or e-health has been tried along with mindfulness [ ] . korea has a dualized medical system called western medicine and korean medicine (km) and "the covid- telemedicine center of km" has treated more than % of confirmed covid- patients in korea with telemedicine since march ( figure ). initially, the telemedicine center was established by the association of korean medicine (akom), a representative organization of all km doctors established in the early s, at daegu korean medicine hospital, daegu, korea, where the number of covid- patients increased rapidly. after the outbreak was controlled in daegu and gyeongbuk, akom set up a second covid- telemedicine center of km in seoul. the center uses herbal medicine (mainly qing-fei-pai-du-tang) with established protocols based on multidisciplinary expert discussions and empirical evidence [ ] , and the center also used telemedicine in conjunction with mind-body modalities (including mindfulness meditation) to improve the mental health of covid- patients in korea. the aim of this paper is to introduce the km doctor's mental health instruction manual in telemedicine for covid- and to provide insights into the development of mental-health interventions for covid- patients and large-scale disasters in the upcoming "new-normal" era. into the development of mental-health interventions for covid- patients and large-scale disasters in the upcoming "new-normal" era. to better manage the mental health of covid- victims and survivors, the covid- telemedicine center of km requested specialists in oriental neuropsychiatry to develop the km doctor's mental health instruction manual in telemedicine for covid- in a written format. specifically, the manual was developed by professors, professor jong woo kim who is also the corresponding author of this article and professor sun-yong chung, at the department of oriental neuropsychiatry at kyunghee university in korea. moreover, they practice the hwa-byung and stress clinic at the kyunghee university korean medicine hospital at gangdong and have used mindfulness meditation in their clinical practice for over years. professor kim, the primary author of this manual, is also the president of the korean society for meditation [ ] . as is the case in other countries, the covid- pandemic caused an unprecedented crisis in korea and there were no previously reported cases of using telemedicine for mental health during such catastrophes. in addition, due to the urgency of developing the manual there was not sufficient time to conduct a comprehensive systematic review of the literature regarding the development of such a manual and intervention for human subjects. instead, the two professors and an assistant, dr. hui-yong kwak who is one of author of this article, developed this manual using empirical evidence obtained from not-systematic review methodology as well as clinical experiences from their clinical settings. this manual was intended to enable km doctors to provide appropriate guidance and counseling for individuals who needed mental health care via a novel method of telemedicine. specifically, it provided guidance on managing psychological problems, such as anxiety, depression, fear, and anger, and related physical symptoms such as pain, digestive problems, and insomnia. throughout the manual, km doctors categorized the potential psychological condition of individuals, and explained the symptoms that may happen in this stressful situation and guided potentially useful mind-body interventions. the target population of the manual was primarily confirmed covid- patients. in addition, it could be applied to people who were self-contained in contact with the confirmed patient, the family and acquaintances of the confirmed patient, and the general public complaining of anxiety related to covid- . to better manage the mental health of covid- victims and survivors, the covid- telemedicine center of km requested specialists in oriental neuropsychiatry to develop the km doctor's mental health instruction manual in telemedicine for covid- in a written format. specifically, the manual was developed by professors, professor jong woo kim who is also the corresponding author of this article and professor sun-yong chung, at the department of oriental neuropsychiatry at kyunghee university in korea. moreover, they practice the hwa-byung and stress clinic at the kyunghee university korean medicine hospital at gangdong and have used mindfulness meditation in their clinical practice for over years. professor kim, the primary author of this manual, is also the president of the korean society for meditation [ ] . as is the case in other countries, the covid- pandemic caused an unprecedented crisis in korea and there were no previously reported cases of using telemedicine for mental health during such catastrophes. in addition, due to the urgency of developing the manual there was not sufficient time to conduct a comprehensive systematic review of the literature regarding the development of such a manual and intervention for human subjects. instead, the two professors and an assistant, dr. hui-yong kwak who is one of author of this article, developed this manual using empirical evidence obtained from not-systematic review methodology as well as clinical experiences from their clinical settings. this manual was intended to enable km doctors to provide appropriate guidance and counseling for individuals who needed mental health care via a novel method of telemedicine. specifically, it provided guidance on managing psychological problems, such as anxiety, depression, fear, and anger, and related physical symptoms such as pain, digestive problems, and insomnia. throughout the manual, km doctors categorized the potential psychological condition of individuals, and explained the symptoms that may happen in this stressful situation and guided potentially useful mind-body interventions. the target population of the manual was primarily confirmed covid- patients. in addition, it could be applied to people who were self-contained in contact with the confirmed patient, the family and acquaintances of the confirmed patient, and the general public complaining of anxiety related to covid- . to identify the potential psychological condition of individuals, the following three steps were used. the majority of these questions are leading, since this manual was applied to all individuals receiving telemedicine services at this center and the number of staff (mostly volunteers) was limited. therefore, questions were constructed to quickly and efficiently assess the need for mental health care and identify the presence of related symptoms (table ) . table . history taking: -step approach. step "do you feel distressed or need psychological support for symptoms such as overstrain, dyspepsia, and insomnia?" step "if so, can you quantify it? please express it as a number between and . set the most severe level as and answer when there are no symptoms at all." step overstrain "do you think that you have been more nervous in your daily life than necessary?" fear "are you struggling with fear or fear of the coronavirus?" anxiety "do you have a lot of worries or thoughts that constantly make you feel restless and anxious?" lethargy/depression "do you feel depressed without having fun, or are you feeling lethargy?" insomnia "are you suffering because you haven't been sleeping well these days? if you don't sleep easily, wake up often in the middle night, or wake up too early in the morning, making you feel tired throughout the day, that means you are not sleeping well." dyspepsia "is it uncomfortable when you eat food these days? are you reluctant to eat with reduced appetite or indigestion?" pain "do you have new pain whenever you feel bad? or do you feel more unpleasant pain in the areas where you felt pain before? " anger/irritability "have you easily become angry or annoyed these days?" in the telemedicine of the km center, km doctors explained the mechanism of symptom occurrence that individuals complain about, and each recommended modality. all counseling required an explanation of the current situation and empathy for the individual ( table ) . table . guidance for symptom management. overstrain tension is a natural phenomenon of the human body to survive in the stress response theory (fight or flight reaction). the constant rumination creates overstrain, even in non-existent events. notice the thoughts that make you nervous. imagine the thought of relaxing yourself repeatedly, and if this is difficult, focus on the physical stimulus to relax your body (e.g., half body bath, listening to music, walking, etc.) table . cont. the reaction of fear appears when the stress response to protect our body from danger is extremely severe. fear is easily learned, and when a circuit of thought is formed for the fearful situation, the emotion can be reproduced whenever the situation appears or a related thought arises. if you experience panic, you may develop a fear (expected anxiety) that the symptoms will occur again. once panic is experienced, expectation anxiety may follow. in case of an excessive fear reaction, prevent hyperventilation and induce parasympathetic activity through exhalation-oriented deep breathing. repeatedly reaffirm the sense of security that can cope with fear. if you are relaxed and calm enough, try exposing yourself to the usual stimuli that triggered your fear response. acutely, anxiety appears with the reaction of fear. anxiety is closely related to the thought process. when a person falls into the thought that triggers anxiety, more and more thoughts are continually generated, and in this process, anxiety can be strengthened. notice that you are anxious. this is the first step in laying down the thoughts that cause anxiety. instead of turning your attention to other thoughts, it is helpful to focus on your body sensations instead. reactive depression can occur when an acute emotional reaction occurs, but the situation persists unchanged, and the mental energy that an individual can consume has reached a limit. in addition, individual vulnerability is a risk factor that easily causes lethargy and depression. decreasing physical activity exacerbates depression. find out your own new rhythm in a small space called "home." discover and expand positive energies like charity, empathy, loving-kindness, and mercy that exist in your mind. depression, anxiety, and decreased physical activity can cause insomnia. insomnia has a close relationship with cognitive factors, and if insomnia causes anxiety, this anxiety can exacerbate insomnia again. bad sleep hygiene and sleep habits can also cause insomnia. the solution to insomnia is based on the recovery of biorhythm. that is, a rhythm that is sufficiently active during the day and rests during the night should be restored. in case of worries, anxiety, and tension that persists insomnia, apply methods of relaxing the body and attempt mental distraction methods. please observe good sleep hygiene. if you are taking sleeping pills, you need guidance and management on how to take the correct sleeping pills. depression can reduce appetite. if a person eats only similar foods in a limited space, and the number of people who can eat together is limited, depression and loss of appetite become more severe. if the sympathetic activity continues to be elevated, the movement of the digestive system is not smooth. this leads to a decrease in gastric motility, causing some symptoms, including dyspepsia. imagine the memory of eating something delicious before the current eating situation and promote your appetite. eat meals regularly, and after eating, help the gastrointestinal tract to digest enough through physical activities, such as walking lightly. it is better to eat even a small amount of fun and delicious food, rather than eating it excessively and vigorously. local pain can be caused primarily by muscle tension in the area. body pain is closely related to cognitive factors. worries about the pain, psychological tension, anxiety, and depression can amplify the pain condition. it is important to know that thoughts, feelings, and pain are closely related. try some work or activity that reminds you of thoughts other than pain or that may make you forget about pain. observe the pain from the point of view that it is not just a bad thing or an unpleasant event, but simply a signal or sensation from your body. anger/irritability anger emotion suggests the resistance to the irrational and absurd reality from the thought that you have been harmed by the current situation. anger induces a state of tension in the short term, so it instantly boosts the body's metabolism and activates the immune system. chronic anger and tension, however, can depress the immune system and lead to depression, lethargy, and some somatic symptoms. understand that current anger is a natural reaction to the situation. find other activities or ways to express this intense energy. some relaxation modalities may be appropriate methods. it is important to be an objective third-party observer of this situation that is damaging to me. this manual consists of care algorithms for individuals that included the symptom, education on each symptom, basic modalities, and individual mind-body modalities. based on this care algorithm, three basic modalities including simple breathing, mindful breathing, and walking meditation were suggested twice a day for overall mental health improvement. for each symptom that an individual complained of, individual mind-body modalities were suggested to improve the symptom (table ) . in the case of "basic modalities," it is recommended the modalities be carried out regularly, such as once in the morning and evening, whenever possible. in the case of "individual modalities," it is recommended to perform the suggested modalities when symptoms occur. a description of the mind-body modalities for symptom management is provided in table . individuals may achieve efficient self-management of their symptoms through youtube videos in which detailed instructions for each modality are provided [ ] . table . mind-body modalities for symptom management. simple breathing repeat your inspiration and exhalation to find your original rhythm. find the most stable, comfortable, and balanced one. breathe and feel safe and comfortable. observe your breath. let us observe the inspiration and exhalation. try to feel cool air coming into your body and turbid air coming out of your body. breathing confirms that your body is clear and healthy. try to feel that your body is clear and healthy throughout this breathing exercise. walking meditation step on the ground and make sure it is stable and firm. while walking slowly, check that it is stable-unstable-stable again. walk to your own rhythm and find yourself comfortable and balanced. even in a small space, you can see the vitality of movement. divide the body parts and try to repeat the local tension and relaxation. tension your muscles while you breathe in and relax your muscles while you exhale. this process begins with your hands and spreads to each part of the body. throughout this process, make sure that your body is sufficiently relaxed. try to create the most stable and relaxed state. notice that both hands are warm. notice that both hands are heavy. notice that your heart beats regularly. notice that your breathing is comfortable. notice that your lower abdomen is warm. notice that the forehead is cool. breathe with the numbers to focus more on your breathing. each time you breathe in and out, count backwards starting with to . focus only on breathing and numbers, and if you have other thoughts, try to focus on the breathing again. as you breathe comfortably, notice your body sensations, thoughts, and emotions. if a disturbing thought or emotion occurs, just observe it with tranquility. observe how it changes. it is important to take a non-judgmental attitude, rather than resisting or interpreting its meaning. let us check the warm heart we originally had. think about the sadness that a mother feels when seeing a sick child, or the wish that the child will be cured. let's extend that warmth to me, to my family, to my friends, and to my health care provider. try to be mindful when eating. do not rush food automatically, see it with your eyes, take it with the nose, taste it with the tongue, chew it with the teeth, swallow it with the throat, pass it through the esophagus, fill the stomach, and eventually feel satisfied. also, imagine that the energy generated in this process is supplied to the whole body. observe your body closely. identify the sensations, feelings, or pains felt in each area and accept it as it is. just accept it while looking. in the process of scanning the whole body, make sure that your body and mind are gradually relaxed. feel the warm energy in your palms. use that warm energy to deliver it to places where your body is uncomfortable or where you are in pain. make sure that the warmth is relaxing your symptoms and pain. when you are done, put your hands on top of your belly and deliver the warm energy to your body. km doctors explained why immunity plays an important role in the prevention and recovery of virus infection, including sars-cov- infection, to the individuals [ ] . in addition, the impact of mind health on immunity was also explained. question . why is immunity important in the covid- era? answer . currently, no cure or vaccine for the new coronavirus has been developed. although no such treatments or vaccines have been developed, there are thousands of covid- patients who are self-healing. this is because the most important weapon against viruses is the body's immunity. since sars-cov- inhibits cells involved in immunity when it enters the human body, it is best to maintain and regulate immune function before the infection. question . does our mind or mood affect immunity? answer . depression or anxiety can decrease the activity of immune cells and increase the level of inflammation, thereby increasing the risk of preventing the body from responding appropriately to viral infections. short-term stress causes the human body to produce more immune cells, but long-term stress rather causes an accumulation of inflammatory substances, disrupting the immune system homeostasis. are there any recommended actions to improve immunity? answer . eating foods rich in antioxidants; getting enough sleep; exercising regularly; and it is important to get away from excessive psychological stress. simple activities such as singing, exercising, foot bathing, or even watching comedy movies, can help boost the release of immune-related molecules. question . are there any contraindications that can impair immunity? answer . eating junk food; breaks in life rhythms including sleep cycles; decreased physical activity; anxiety, repeated psychological stress, among others, have a detrimental effect on immunity. in particular, the sleep cycle plays a very important role in regulating the cycle of the immune system, and chronic sleep deprivation affects the balance of inflammatory cytokines, causing vulnerability to hypersensitivity reactions. in addition, excessive anxiety about the future and regret about the past can exacerbate negative emotions and physical symptoms, which can act as a burden on the immune system. answer . as a result of measuring the inflammation level and activity of the immune system in various studies, it was reported that when meditating, the body's inflammation level was lowered and the immune system activity was increased. representatively, there are some studies of mindfulness meditation and loving-kindness meditation. what is the principle of relaxation? answer . relaxation can be applied as a simple means to reduce physical and mental tension. the scope of relaxation is very comprehensive, and the breathing method is also used as a preparation step before starting a full-scale meditation. in relaxation, focusing on body sensations is a key concept. the most effective way to stay in the 'here and now' is to focus on the body sensations. answer . mindfulness is 'observing what is, as it is.' it is to create a state of staying here after putting down a lot of thoughts that arise automatically, such as certain preconceptions and stereotypes. in mindfulness, one's mind is not deceived by thoughts or other body sensations and can focus on a specific object or phenomenon itself. in fact, if you look at your body and mind excluding "interpretation" and "prejudice" among others, you will notice that you are in a clearer mind and more comfortable body than before. answer . loving-kindness meditation is often called social meditation. loving-kindness is the desire for people to be peaceful and happy, and compassion is the desire for people to escape from suffering. in a situation of disconnected and lonely alienation, you will be able to fill the natural energy and solidarity of human beings by having a warm heart and by practicing passing it on to others or to yourself. with the introduction of this manual, we look forward to the widespread use of mind-body medicine, including mindfulness-based interventions, to improve mental health in other disaster areas. however, in order for this manual to be applied in other environments, some limitations must first be taken into account. first, simple mental health measures should be introduced to simplify the evaluation of individuals' mental health in the telemedicine environment. since the creation and implementation of our manual was conducted during a pandemic, and not for the purpose of a study, it was insufficient to consider it as a proper outcome indicator. some indicators, such as the beck depression inventory, the beck hopelessness scale, the hamilton anxiety rating scale, and the pittsburg sleep quality index may be considered [ ] , but considering the nature of telemedicine at disaster sites, it may be necessary to consider a simpler format. also, in combining telemedicine and measurement of mental health, the digital privacy of patients must be considered [ ] . second, although the mind-body modalities introduced in our manual were provided through youtube videos, youtube videos have one-way characteristics. based on our clinical experience of mindfulness meditation, we believe the application of mind-body modalities, including mindfulness meditation, is more effective in an interactive communication environment. specifically, a sufficient feedback process is required following each practice, and this may be achieved by using programs such as zoom meetings. in the digital interactive communication environment, such as via zoom technology, it is possible to consider the construction of an online community-based meditation practice that may contribute to improving public mental health via web-based social interaction. third, although mindfulness meditation is a popular mind-body modality that is widely accepted, not only in eastern cultures, but also in western cultures, the cultural, ethnic, and religious/spiritual characteristics of patients should still be considered and respected. for example, in countries like china, tai chi or qigong may be a more familiar movement to cultivate mindfulness [ ] , while in the united states, although not considered in our manual, spiritual meditation or mantra meditation may be good options [ ] . fourth, mental health telemedicine interventions for front-line healthcare providers also need to be developed. our manual has been established for the general public or for infected patients, but today covid- poses a serious risk for first-line medical staffs' mental health [ ] . therefore, a revised manual may include strategies to improve mental health and relieve psychological stress for medical staff. fifth, more specific scripts are needed for each stressful situation. for example, individual modalities could be developed according to events that may be applied to specific cases, such as family discord, social conflicts, helplessness, and despair. finally, although our manual is limited, mindful movements such as yoga, tai chi, and qigong may be useful strategies for mental health interventions through youtube videos or software like zoom meetings. importantly, because these movements transcend language barriers, they are likely to be helpful to foreigners residing in korea, as well as other citizens residing outside korea. in view of these above limitations, future studies on mental health management using telemedicine for covid- might consider the following issues. researchers should consider adopting a validated and simple form of mental health assessment tool for the initial and follow-up assessments of individuals. a comprehensive review by beidas et al. ( ) is helpful in developing the evaluation strategy [ ] . also, mental health interventions based on smartphone applications are increasing today, and some of these applications evaluate the emotional psychopathology of users through assessment tools such as the -item patient health questionnaire or -item generalized anxiety disorder scale [ ] . therefore, if the policy makers and information technology (it) experts can consider and authorize the linkage of information between telemedicine and existing mental health applications, mental health assessment in the field of telemedicine is likely to improve. for the use of mind-body modalities in telemedicine, bidirectional communication between the individual and practitioner could be emphasized. youtube videos or communication software, such as zoom may facilitate bidirectional communication; such recent advances in online video technologies have increased the potential utilization of mindful movements such as yoga, tai chi, and qigong. the fear and social distancing caused by covid- emphasized the importance of recognizing the mental health of all individuals. here, mindfulness is a promising intervention that may be combined with telemedicine. many attempts, such as telephone-adapted mindfulness-based stress reduction [ ] and mhealth mindfulness intervention [ ] have already been made. in this short paper, we introduced the "km doctor's mental health instruction manual in the telemedicine for covid- " as a pilot manual used by the patients attending the covid- telemedicine center of km in korea. in this manual, a mindfulness-based intervention was introduced and may play an important role in assisting individuals faced with a pandemic or other emergency-situations. based on our experience, we propose health authorities in other countries consider the establishment of telemedicine-based mental health management strategies and further share their experiences and potential research. for mental health care in the upcoming "new-normal" era, mindfulness-based interventions are promising mind-body modalities. who timeline-covid- evidence based management guideline for the covid- pandemic-review article recent progress and challenges in drug development against covid- coronavirus (sars-cov- )-an update on the status emerging evidence for neuropsycho-consequences of covid- covid- pandemic and impending global mental health implications effects of covid- pandemic in daily life psychosocial impact of covid- choices for the "new normal multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science turning the crisis into an opportunity: digital health strategies deployed during the covid- outbreak virtual health care in the era of covid- effectiveness of mindfulness-and relaxation-based ehealth interventions for patients with medical conditions: a systematic review and synthesis traditional chinese medicine for covid- treatment youtube channel of the association of korean medicine the trinity of covid- : immunity, inflammation and intervention rapid response reports: summary with critical appraisal. in telehealth for the assessment and treatment of depression, post-traumatic stress disorder, and anxiety: clinical evidence; canadian agency for drugs and technologies in health digital privacy in mental healthcare: current issues and recommendations for technology use chi as exercise among middle-aged and elderly chinese in urban china prevalence and patterns of use of mantra, mindfulness and spiritual meditation among adults in the united states mental health care for medical staff and affiliated healthcare workers during the covid- pandemic telephone-adapted mindfulness-based stress reduction (tmbsr) for patients awaiting kidney transplantation: trial design, rationale and feasibility a randomized controlled trial of mhealth mindfulness intervention for cancer patients and informal cancer caregivers: a feasibility study within an integrated health care delivery system this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the authors are grateful for the support and cooperation with covid- telemedicine center of korean medicine and the association of korean medicine. the authors declare no conflict of interest. key: cord- -rknygv u authors: fraser, michael r.; hardy, george title: astho at : celebrating the past and preparing for the future date: - - journal: j public health manag pract doi: . /phh. sha: doc_id: cord_uid: rknygv u nan support these state leaders, the s/thos at the time believed that their "sanitary and other public health laws and regulations was a responsibility that merited and could be best served through an autonomous organization." of course a great deal has changed over the last years, but the original purpose of astho has remained constant: to convene s/thos nationwide and educate members on current issues, discuss state and territorial public health priorities, address urgent health needs, and advocate for continued support for the governmental public health enterprise. the history of astho authored by nancy maddox (pages - ) in this special section provides an excellent overview of astho's past with a keen eye toward its future. as de tocqueville notes in the aforementioned quotation, a unique feature of american democracy is the formation of voluntary associations created to promote shared values, goals, and policy agendas. in this regard, astho is no different from the thousands of other trade associations and professional societies that cover the vast array of interests on behalf of their various constituencies in our nation's capital. but astho is unique: there is no other national association that represents and convenes the leadership of s/thos and is concerned with the wide variety of issues and policies that directly impact state and territorial health agencies. astho's core mission is future-focused and dynamic: astho exists to "transform public health within states and territories to help members dramatically improve health and wellness." to accomplish its mission, astho supports the leadership and professional development of s/thos and their executive teams, it advocates for the work of member agencies, and it collaborates funding partners and public health stakeholders to build the capacity of state and territorial health agencies. over the last years, astho's capacity-building work has led to the development of a substantial body of technical assistance and training support for state and territorial health agencies in the many programmatic and operational areas of agency performance. today, astho employs a professional staff of more than public health professionals, manages an annual budget of $ million, is active in all states, territories, and pacific freely associated states, and relies on countless hours of volunteer leadership and subject matter expertise of current health officers, astho "alumni," senior deputies, and affiliated public health organizations and associations to carry out its work. astho, like many national public health associations, enjoyed rapid growth in the s as federal grants and contracts created new opportunities for public health organizations to provide technical assistance and training on a variety of public health issues. the primary funding partners for these cooperative agreements were the agencies that worked most with state and territorial health agencies including the centers for disease control and prevention (cdc) and the health resources and services administration (hrsa). however, over time, programs with the office of minority health, the food and drug administration, the environmental protection agency, the substance abuse and mental health services administration, and the national highway and safety and transportation administration along with other agencies also built the capacity of the state and territorial health agencies and astho. these investments allowed astho to offer technical assistance and training as well as grow internal operational and organizational capacity for communications activities and policy work. main topic areas of these projects included addressing communicable disease, chronic disease, maternal and child health, environmental health, health systems change, health equity, and public health informatics and surveillance capacity. work to build the public health workforce and assess the capacity of local and state public health agencies was also started in the s through agreements with the cdc, hrsa, and national philanthropic partners including the robert wood johnson foundation, the de beaumont foundation, and the w.k. kellogg foundation. the development of the state health leadership initiative (shli), funded by the robert wood johnson foundation, further catalyzed astho's growth and its abilities to communicate with and convene s/thos. the shli provided the opportunity for the astho executive director to visit new s/thos, supported s/tho leadership development through an executive leadership institute at harvard university's kennedy school of government, to offer experienced s/tho mentorships to new s/thos, and to convene annually in an s/tho-only strategic session. now in its th year, the shli has expanded to include both executive leadership development and multisector leadership training to develop s/thos' abilities to create a "culture of health" within their jurisdictions. similar workforce development investments have allowed astho to convene executive leaders in state and territorial health agencies, including senior deputies, legislative liaisons, and program leads in the areas of public health preparedness, environmental health, informatics, human resources, finance, and several others. the terrorist attacks of september , , and the anthrax attacks that followed in october propelled astho to its next level of growth ( figure) . amid wide recognition that governmental public health is critical to emergency preparedness and response, large investments were made at the local and state levels in public health preparedness capacity nationwide. astho received federal dollars through cooperative agreements with the cdc and the assistant secretary for preparedness and response to convene state and territorial public health officers and preparedness directors, support state efforts to build preparedness and response programs, and assist in national disasters and emergencies as a response partner. the modern era of "public health preparedness" had begun as did a "new normal" in public health that required active involvement in homeland security efforts on a basis of hours, days a week. discussions around how federal dollars for preparedness should be allocated at the state and local levels led to the development of the astho-naccho (national association of county & city health officials) joint council. convening health officers to discuss coordinated emergency response efforts to hurricane katrina, the gulf of mexico oil spill, the h n outbreak, and severe acute respiratory syndrome outbreak laid the groundwork for astho's role in supporting state and territorial health agencies and federal partners during public health disasters. working collaboratively with nac-cho, the astho-naccho joint council also became an increasingly important factor in policy formulation and advocacy for governmental public health. in the early s, the executive directors and staff of astho, naccho, nalboh (the national association of local boards of health), and apha, working with the iom (institute of medicine), asph (the association of schools of public health), and ceph (the council on education for public health), spent considerable time debating and creating a framework for the accreditation of official governmental public health agencies. that effort grew into the local and state health department accreditation program incorporated by astho, naccho, apha, and nalboh, a new c named the public health accreditation board (phab) and on which astho has an ex-officio seat. as of , a total of state and territorial health agencies have received phab accreditation. building on the response to the hiv/aids epidemic in the s and s, astho grew its infectious disease portfolio in the early s and continued to represent the interest of s/thos on national advisory boards and committees including federal advisory committees such as the national vaccine advisory committee and several workgroups and committees of the national academy of sciences, engineering, and medicine. programs to address the growing burden of noncommunicable diseases also expanded in the s and early s as the united states witnessed large jumps in the rates of overweight and obesity nationwide. in , astho was one of founding members of the national forum on heart disease and stroke. astho also created the alliance to make us healthiest, a national certification program recognizing excellence in workplace wellness. in , astho president judy monroe called on s/thos to "walk the talk" on obesity prevention and commit personally and professionally to increasing physical activity and lead efforts to promote healthier lifestyles. this effort began the astho "president's challenge" program, in which the astho president calls on peers to actively address specific public health issues or topics (table ) . astho president's challenges have led to significant work on several priority issues at the local, state, and federal levels including major work on preventing premature birth and infant mortality. as astho moved into the new millennium, it continued to grow as a vocal and active advocate for state and territorial public health agencies. programs in the areas of performance improvement, public health informatics, public health systems and services research, the integration of public health and primary care, responding to novel pathogens such as h n , sars, west nile virus, and ebola virus, tobacco prevention and control, water and air quality, the impact of climate change on health, and other topical areas allowed astho to partner closely with state and territorial health departments and their leadership teams. astho also continues to cultivate the astho affiliate council: a group of other state and territorial health organizations with specific constituencies such as chronic disease directors, health care accreditation agencies, public health nurses, oral health directors, hiv/aids directors, maternal and child health program directors (table ). in recent years, astho also built its tracking capacity to monitor state and territorial legislative activity pertaining to public health. astho maintains an active database of state and territorial legislative initiatives that relates to health and partners with peer associations including the national governors' association, the national conference of state legislatures, and national association of attorneys general. today, astho continues to support the orientation and onboarding of s/thos through its shli. s/tho tenure has decreased from an average of . years in the s to an average of . years between - , making the need for s/thos to "hit the ground running" even more important. the characteristics of tenured s/thos and factors influencing s/tho longevity in their role are described by halverson in this special section (pages - ). leadership competencies are now a core part of the program (table ) . training s/thos in these competency areas is aimed at bringing newly appointed s/thos "up to speed" quickly in their leadership roles as chief health strategists in states and territories. research on the state and territorial public health workforce continues to be a signature product of astho, including the profile of state and territorial health agencies and most recently illustrated by the de beaumont foundation-funded public health workforce interests and needs survey (phwins). the passage of the affordable care act (aca) in march created new opportunities for state and territorial health agencies and for astho beyond the aca's core focus on expanding health insurance coverage to millions of uninsured americans. the maternal, infant, and early childhood home visiting program supported the scale and spread of evidencebased home visiting programs in many state and territorial health agencies' maternal and child health programs. new opportunities to prevent chronic diseases, unintentional injury, and other leading causes of morbidity and mortality were established in the nation's first ever source of dedicated funding for prevention: the prevention and public health fund. astho supports several prevention and public health fund programs including the million hearts initiative, tobacco use prevention, and initiatives to expand breastfeeding at the state and territorial levels. the aca also led to new challenges for astho and its members. questions about the public health agency role as a safety net provider were raised and threatened to lead to funding reductions because state health agency efforts were perceived of as duplicative of services covered by health insurers. while concerns that state immunization, std/sti prevention and control, breast and cervical cancer screening, infant mortality/ preterm birth prevention, hypertension, and child and youth with special health care needs programs would be eliminated by the aca have not been realized, there are lingering questions about why public health agencies are funded to provide the delivery of clinical services when the population traditionally served by state and territorial health agencies is now medicaid eligible or may obtain health insurance coverage through the federal health care exchange. astho has grown through the continued engagement of its members and funding partners, especially federal agencies such as the cdc and hrsa. as discussions over the federal budget and deficit spending continue in washington, district of columbia, many public health leaders believe that overall federal public health funding will be cut by congress in future federal budgets, having a profound impact on the work of state and territorial health agencies as well as astho. future work at astho to "make the case" for sustained investment in public health and defend against potential cuts builds on past efforts to illustrate the impact of funding reductions to public health. a new area of work at astho is activity to demonstrate the return on investment of many public health programs administered by astho members. astho's ability to lead in public health advocacy and policy will be even more critical in the years to come as efforts to prevent disease and promote health continue to increase and government funding for public health is potentially reduced. current debates over the aca have pushed prevention and public health into the limelight, as there is growing recognition that health insurance coverage alone is insufficient to create good health. state and territorial health agencies will continue to face challenges in ensuring access to care and prevention of those things that lead people to seek care in the first place. the role of public health in injury prevention, chronic disease prevention, communicable disease control, and environmental health is as important as ever. astho's work to support "health care transformation" in a brave new world of health care transformation and cost containment is an area of great opportunity in the future. much of the future work in public health will involve alignment, coordination, collaboration, and integration with the "nonhealth" sector, including housing agencies, transportation, economic development, and education. perhaps, most importantly, the future of astho is deeply connected to its past. the issues that drove those first health officers to form astho may be different today, but the need to convene and advocate for state and territorial public health programs is as important as ever. given the extreme partisanship and political discord in washington, district of columbia, and across the country, what the future holds for governmental public health is unclear. leaders of state and territorial public health agencies of the future, as described by fraser and castrucci on pages - of this special section, will need to have the capacity to synthesize vast amounts of data, solve complicated public health problems, and push for policy changes that have the most impact on addressing health equity and ensuring optimal health for all in an environment of resource constraint. while the future is unclear, what is certain is the continued need for astho and the work it carries out in the areas of leadership development, advocacy, and capacity building for state and territorial public health officers and teams and agencies they lead. historical roster of state and territorial health officials, to association of state and territorial health officials. about us. www. astho.org/about public health accreditation board. data on state and territorial health agencies accredited as of april , . www.phaboard.org/ new-room/accredited-health-departments astho's state legislative tracking database. www.astho.org/ state-legislative-tracking high turnover among state health officials/public health directors: implications for the public's health key: cord- -ljg sj authors: slotwiner, david j.; al-khatib, sana m. title: digital health in electrophysiology and the covid- global pandemic date: - - journal: heart rhythm o doi: . /j.hroo. . . sha: doc_id: cord_uid: ljg sj the tools of digital health are facilitating a much needed paradigm shift to a more patient-centric health care delivery system, yet our healthcare infrastructure is firmly rooted in a (th) century model which was not designed to receive medical data from outside the traditional medical environment. covid- has accelerated this adoption and illustrated the challenges that lie ahead as we make this shift. the diverse ecosystem of digital health tools share one feature in common: they generate data which must be processed, triaged, acted upon and incorporated into the longitudinal electronic health record. critical abnormal findings must be identified and acted upon rapidly, while semi-urgent and non-critical data and trends may be reviewed within a less urgent timeline. clinically irrelevant findings, which presently comprise a significant percentage of the alerts, ideally would be removed to optimize the high cost, high value resource; i.e., the clinicians’ attention and time. we need to transform our established health care infrastructure, technologies and workflows to be able to safely, effectively and efficiently manage the vast quantities of data that these tools will generate. this must include both new technologies from industry as well as expert consensus documents from medical specialty societies including the heart rhythm society. ultimately, research will be fundamental to inform effective development and implementation of these tools. the tools of digital health are facilitating a much needed paradigm shift to a more patient-centric health care delivery system, yet our healthcare infrastructure is firmly rooted in a th century model which was not designed to receive medical data from outside the traditional medical environment. covid- has accelerated this adoption and illustrated the challenges that lie ahead as we make this shift. the diverse ecosystem of digital health tools share one feature in common: they generate data which must be processed, triaged, acted upon and incorporated into the longitudinal electronic health record. critical abnormal findings must be identified and acted upon rapidly, while semi-urgent and non-critical data and trends may be reviewed within a less urgent timeline. clinically irrelevant findings, which presently comprise a significant percentage of the alerts, ideally would be removed to optimize the high cost, high value resource; i.e., the clinicians' attention and time. we need to transform our established health care infrastructure, technologies and workflows to be able to safely, effectively and efficiently manage the vast quantities of data that these tools will generate. this must include both new technologies from industry as well as expert consensus documents from medical specialty societies including the heart rhythm society. ultimately, research will be fundamental to inform effective development and implementation of these tools. as the medical community addresses the complexities associated with the coronavirus disease- (covid- ) pandemic, digital health tools, by communicating physiologic data recorded outside the traditional boundaries of the healthcare environment, are providing solutions to many of the challenges. the pandemic has accelerated the adoption of digital health, yet our healthcare system infrastructures are firmly rooted in a th century closed loop delivery model: systems have been designed to enable clinicians to place an order for diagnostic and therapeutic interventions which are then performed within the traditional boundaries of the clinician's office, hospital, or other clinical care settings. for the most part, current healthcare systems are suited for these tasks: the test is performed, a report is generated, and the results neatly arrive in the clinicians' in-box. the results are reviewed with patients either by phone, via the patient portal, or at the next clinic encounter. this healthcare clinician centric model was ripe for disruption, and the era of digital health and the global covid- pandemic has indeed forever changed care delivery. physiologic data captured outside the traditional medical environment by digital health tools are fundamentally changing the way patients and clinicians communicate, manage diseases, and maintain health. the extensive recording and transmitting of physiologic data and engaging patients in the data collection and review process have caused a paradigm shift. despite the paucity of data, many have postulated that this new model of healthcare delivery will result in significant improvements in patient outcomes. ( , ) ( ) yet the traditional medical establishment, structured around office encounters and periodic testing, is not well suited to evaluate and manage the incessant stream and vast quantity of data and alerts generated by these near continuous monitoring devices. additionally, little attention has been devoted to addressing how such data will enter the medical establishment, or how it will be incorporated into the electronic medical record. it is not fully understood how patients and their clinicians should most effectively communicate between scheduled office encounters. in this article, we describe the present state of heart rhythm digital health tools highlighting some of the effects of j o u r n a l p r e -p r o o f the covid- pandemic and propose ways to develop innovative workflows and technological solutions that will make it possible for practices to efficiently process and manage information. in addition, we highlight some of the research gaps that should be addressed to push this field forward. heart rhythm digital health tools fall into broad categories: medical grade implantable devices such as cardiac implantable electronic devices (cieds), medical grade wearable monitors such as mobile cardiac telemetry monitors, and consumer devices that record physiologic data such as heart rate, activity, and single lead electrocardiograms. there is a diverse ecosystem of digital health tools that generate many different types of data. however, there are similarities between the underlying data, need for triaging and responding to the data, as well as the importance of incorporating the data into the electronic medical record. critical abnormal findings must be identified and acted upon rapidly, while semi-urgent and non-critical data and trends may be reviewed within a less urgent timeline. clinically irrelevant findings, which presently comprise a significant percentage of the alerts, ideally would be removed to optimize the high cost, high value resource; i.e., the clinicians' attention and time. cardiac implantable electronic devices (cieds) cieds, the most sophisticated of our digital health tools, have the highest resolution recordings and highly refined software algorithms capable of accurately identifying most arrhythmias and virtually eliminating artifacts except in clinically important scenarios of device or lead malfunction. yet remote monitoring of these devices poses a massive data burden on clinical practices because practices still must interpret and triage data according to clinical relevance for an individual patient. for example, the clinical significance of non-sustained j o u r n a l p r e -p r o o f ventricular tachycardia or atrial fibrillation varies tremendously across patients, yet when these alerts are received by a technician at a given practice, each alert must be reviewed and processed by an experienced clinician with equal diligence to ensure that clinically important events are acted upon ( figure a) . a patient with known atrial fibrillation, on appropriate thromboembolic prophylaxis, may have many alerts for atrial fibrillation even following attempts to optimize alert triggers. at a minimum, this requires an clinician process each alert and confirm in the medical record that the patient is known to have atrial fibrillation and is receiving thromboembolic prophylaxis. subcutaneous cardiac rhythm monitors which are prone to detecting artifacts and are at times unreliable at accurately interpreting the heart rhythm add an additional level of burden to a practice. an experienced clinician must review the electrogram recordings to assess if an event is due to an artifact or a true arrhythmia. then, the clinician must manage the arrhythmia. an often overlooked but critical burden for practices is the need to have a rigorous quality assessment process in place to ensure that each patient's remote transmitter is communicating. the present cied remote monitoring technology is designed to communicate a complete data download every days (for pacemakers and implantable defibrillators) or every days (for implantable subcutaneous cardiac rhythm monitors). between these intervals, many vendors have designed their systems to transmit data only if a new event or abnormality is detected. therefore, practices must either have robust processes in place to identify if an individual patient reaches the end of their monitoring interval and their transmitter has not communicated appropriately, or, the practice must monitor each of the cied vendor's web portals, carefully culling any inactive patients from the list, and noting when an alert is triggered indicating that a remote transceiver has stopped communicating. once a practice identifies that a remote transmitter is no longer communicating, the tedious and lengthy process of tracking down the patient and addressing the specific problem may take hours. holter monitors, extended electrocardiogram (ecg) monitors, event recorders and mobile cardiac telemetry monitors record varying degrees of data, but unlike cieds or consumer wearable devices, a well established workflow that includes trained telemetry technicians, nurses or other skilled allied professionals is an essential component of the initial data screening process. as a result, most of the artifact and non-critical findings are presented to the interpreting clinician in a single review session, making the burden of data review and interpretation more manageable. data generated from digital health tools utilizing photoplethysmography to record heart rate or devices capable of recording a single lead ecg pose a different challenge for established medical practices. primary concerns surrounding these devices are fundamental: identifying how data will physically or electronically enter the medical establishment, the quality of the data, the patient and clinician expectations regarding review and communication about the data, and a mechanism for incorporating the data into the patient's longitudinal electronic medical record. many clinicians avoid recommending the use of these tools due to these uncertainties as well as concern that they will be inundated with data of uncertain significance. patients may become unnecessarily concerned by artifact, inaccurate data, and/or overreliance on a device's ability (or inability) to correctly categorize the data as normal or abnormal. the covid- pandemic highlighted both the potential of digital health tools to enable delivery of health care beyond the traditional boundaries of medical facilities as well as the inadequacies of our present health care infrastructure to make this switch. the abrupt shuttering of all but essential hospital-based medical services forced patients and clinicians to turn to j o u r n a l p r e -p r o o f alternative methods of both acquiring health data and communicating the results. telehealth services which previously had struggled to gain traction amongst both patients and clinicians suddenly became routine, with both parties quickly learning to appreciate the advantages of telehealth while also recognizing its limitations. patients with cieds already on remote monitoring were at a distinct advantage as clinicians could rapidly and efficiently identify and triage patients with significant arrhythmias or device malfunctions and reassure the remaining patients to avoid medical environments that could pose risk of covid- infection. medical practices that had not implemented cied remote monitoring were forced either to outsource the technical aspects of initiating and maintaining patients on remote monitoring or to identify resources, educate patients and redeploy staff to figure out the complex process of managing data remotely. identifying well trained technicians and nurses to help manage these data is challenging even in normal times. similarly, patients who had adopted digital health tools such as automatic blood pressure cuffs, pulse oximeters, glucose monitors, consumer single lead ecg recorders were at a distinct advantage as they could provide their clinician with potentially important data that would otherwise require them risking exposure to the medical environment to obtain. yet even the early adopters of digital health tools were left to struggle with sharing the data and how best to communicate with their clinicians. it is likely that changes brought forward by the pandemic will remain and continue to grow even after the pandemic is over. the first critical step to managing the deluge of data from consumer devices is to develop the infrastructure that will make it possible for data recorded by these devices to be securely and reliably communicated and incorporated into a patient's electronic health record. the second step is to develop a mechanism to triage incoming digital health data so that it can be efficiently and effectively managed by a practice (figure b) . triage should be possible by a combination of artificial intelligence tools and clinical pathways that make it possible for staff with varying levels of clinical expertise to stratify incoming data into buckets: ) urgent data that must be reviewed and acted upon as soon as possible by a clinician; ) semi-urgent data that can be sent to a clinician's inbox for review within the next business day; ) elective findings that the clinician will want to review with the patient at their next routinely scheduled encounter, and ) artifact that is incorrectly detected as an arrhythmia. expert consensus documents should guide these clinical pathways, while industry engineers will be called upon to develop artificial intelligence tools. for example, an artificial intelligence tool could provide a first-pass screening to triage data. a cied may communicate an event which it labels as non-sustained ventricular tachycardia with % certainty. if the cied is an implantable cardioverter defibrillator, if the episode lasted beats, and if this was the first event in months, the significance of the event is very different from a beat run of non-sustained ventricular tachycardia detected by a mobile cardiac telemetry monitor placed on a patient with coronary artery disease, a left ventricular ejection fraction of % who is being evaluated for recurrent syncope. the electronic medical record should be able to provide an artificial intelligence tool with sufficient clinical data to enable the tool to determine if the patient has an implantable cardioverter defibrillator and whether this is a new arrhythmia, thereby providing a first pass screen. if the event does not meet this criterion, it is labelled as potentially clinically significant, and triaged accordingly. technology should allow patients to know if an event has been detected, transmitted and reviewed. once reviewed, it should be possible for the clinician to easily communicate with the patient -and vice versa. an achilles heel of the present cied wireless remote monitoring systems is the absence of a robust, streamlined method for both medical practices as well as patients to quickly and reliably be notified if their transceiver stops communicating. it is not uncommon for patients to learn that their remote monitor stopped communicating months after the fact. while each cied manufacturer has made some progress in alerting practices when communication stops, the systems are poorly designed and inconsistent, even within a manufacturer's product line. this basic quality concern requires a higher priority status from industry and may be best addressed by developing an industry standard approach, such as has been taken to consistently and uniformly message the clinical community the definition of the cied elective replacement indicator. managing the patient needs and the data generated by digital health tools requires well trained technicians and nurses, and appropriate staffing numbers have yet to be defined. examiners and educational programs offered by private organizations, these remain out of reach both from a financial as well as time commitment perspective for most allied professionals. difficulty identifying and training staff is the reason some practices are outsourcing the technical components of managing the acquisition and collation of digital health data to independent remote monitoring organizations. the tools of digital health bring several new categories of unanswered questions that require scientific study. the first questions pertain to implementation of these tools. patients and the broader public at large are essential partners in acquiring the data, therefore it is imperative that the design and interfaces of these tools be intuitive to individuals who span a broad range of ages, educational and cultural backgrounds. next, it will be important to assess the quality j o u r n a l p r e -p r o o f and reliability of data that clinicians receive from these tools. this will be an ongoing question as new tools are developed. we then need to identify which tools and what data will form a basis for improving patient-centered outcomes. lastly, we need to understand the best tools and strategies for communication to occur between patients and clinician to maximize patient engagement and optimize the potential benefits of digital health. economics is fundamental to driving change, and to-date this has limited the impact of telehealth and digital health. there was perhaps no greater acknowledgment of this than the digital health tools and the data they generate present new challenges for reimbursement. to date, the public has not expected insurance carriers to pay for consumer devices, but with home blood pressure monitors, heart rate and rhythm monitors, patient expectations are changing. clinician time and effort vary widely based upon the frequency and volume of data received. in the united states, cms has implemented base billing codes with additional add-on codes designated for use when the clinician time exceeds a base value within a day window. it remains unclear if private insurance carriers will follow medicare's example. if compelling evidence indicates that these tools improve clinical outcomes, patients and the public will expect their clinician to be adequately reimbursed for reviewing and interpreting such data. the tools of digital health are facilitating a much needed paradigm shift to a patientcentric health care delivery system. covid- with its attendant need to minimize patient exposure to the health care environment has accelerated the adoption of these tools and illustrated the challenges that lie ahead as we make this shift. we now need to focus attention on adapting our established health care systems, technologies and workflows to be able to safely, effectively and efficiently manage the vast quantities of data that these tools generate. this will require both new technologies to be developed by industry as well as expert consensus documents from medical specialty societies including the heart rhythm society. ultimately, research will be fundamental to inform effective development and implementation of these tools, and to understand how they can be used to achieve clinically meaningful improvements in health care outcomes for patients. • the tools of digital health are facilitating a paradigm shift to a more patient-centric health care delivery system. • our present health care infrastructure was not designed to process, triage and incorporate digital health data generated outside the traditional medical environment. • we must transform our established health care infrastructures, technologies and workflows to be able to safely and efficiently manage the vast quantities of data these tools generate. • research is needed to inform the effective development and implementation of these tools, and to identify which have the potential to improve patient-centered outcomes. weill cornell medicine population health sciences, east th street effectiveness of mobile health application use to improve health behavior changes: a systematic review of randomized controlled trials mobile apps for health behavior change: protocol for a systematic review food & drug administration digital health food & drug administration president trump expands telehealth benefits for medicare beneficiaries during covid- outbreak | cms key: cord- -n j ck authors: gostin, lawrence o.; friedman, eric a.; wetter, sarah a. title: responding to covid‐ : how to navigate a public health emergency legally and ethically date: - - journal: hastings cent rep doi: . /hast. sha: doc_id: cord_uid: n j ck few novel or emerging infectious diseases have posed such vital ethical challenges so quickly and dramatically as the novel coronavirus sars‐cov‐ . the world health organization declared a public health emergency of international concern and recently classified covid‐ as a worldwide pandemic. as of this writing, the epidemic has not yet peaked in the united states, but community transmission is widespread. president trump declared a national emergency as fifty governors declared state emergencies. in the coming weeks, hospitals will become overrun, stretched to their capacities. when the health system becomes stretched beyond capacity, how can we ethically allocate scarce health goods and services? how can we ensure that marginalized populations can access the care they need? what ethical duties do we owe to vulnerable people separated from their families and communities? and how do we ethically and legally balance public health with civil liberties? f ew novel or emerging infectious diseases have posed such vital ethical challenges so quickly and dramatically as the novel coronavirus sars-cov- , which causes covid- . sars-cov- is thought to have originated in a wet market in wuhan, china, in early december, making a zoonotic leap from a bat (through an animal intermediary) to a human. it rapidly spread throughout china with highly efficient humanto-human transmission and has now circumnavigated the globe, with a foothold in every continent except antarctica. the world health organization declared a public health emergency of international concern and recently classified covid- as a worldwide pandemic. as of this writing, the epidemic peak has not yet been reached in the united states, but community transmission is widespread. president trump declared a national emergency as fifty governors declared state emergencies -a situation unprecedented in modern america. in the coming weeks, hospitals will become overrun, stretched to their capacities. widespread social separation is rapidly becoming the norm, with closures of schools and universities, telecommuting, bans on large gatherings, and millions of people isolated in their homes or makeshift facilities. bans on international travel are already pervasive. domestic travel restrictions are exceedingly rare but now within the realm of possibility. officials are even ordering cordon sanitaires (guarded areas where people may not enter or leave), popularly described as "lockdowns" or mass quarantines. for example, san francisco recently ordered a lockdown, with other cities and states closing gathering places (such as bars, restaurants, and movie theaters) and advising residents to shelter in place. when the health system becomes stretched beyond capacity, how can we ethically allocate scarce health goods and services? how can we ensure that marginalized populations can access the care they need? what ethical duties do we owe to vulnerable people separated from their families and communities? and how do we ethically and legally balance public health with civil liberties? a strained health system: surge response, triage, ethical allocation a surge of individuals exhibiting flu-like symptoms, along with the "worried well," will undoubtedly stress the health system. health facilities do not have the capacity to cope with the expected patient numbers: they lack enough critical care beds, ventilators, essential medicines, and personal protective equipment for health workers. n masks, a key tool to prevent respiratory infections, are in short supply. scarcity of health resources not only places covid- patients at risk but will also delay care for patients with urgent needs such as for cancer, diabetes, and heart disease-and even affect safe delivery for pregnant women. disruptions to the health system will likely cause more deaths of persons with a variety of urgent health needs than of patients diagnosed with covid- . in times of crisis and with health systems facing scarcity, hospitals, with guidance from public authorities and professional bodies, must make hard decisions to best ensure optimal health outcomes and fair distribution. how can we avoid the scarcity dilemma? where possible, every effort should be made to avoid the scarcity dilemma altogether. we are already trying to do that through strict physical distancing, which could flatten the epidemic curve and moderate demand on the health system. but since the united states is so late in its mitigation efforts, scarcity is likely to become a reality. what should we do? a world war ii-type mobilization could ramp up the production of personal protective equipment, ventilators, and other essential supplies and equipment that could become scarce. the president should exercise his full authority under the defense production act to mobilize industry to provide urgently needed resources. regions experiencing limited levels of covid- could lend equipment, and deploy first responders, to regions where health system capacity is strained. retired health workers or trained health workers not presently practicing could return to service. with ample funding, leadership, and coordination, scarcity can be, if not entirely avoided, then at least mitigated. the president or governors could also call in the military, national guard, or army corps of engineers for assistance with logistics, supply chains, and even building clinics. how can we ethically balance physicians' duties to patients and to the wider community? standards of care ordinarily require physicians to meet the specific medical needs of their patients. but in a crisis, we may have to shift the standard of care to emphasize the needs of the community, while still providing the best possible individual-level care. this concept was encapsulated by the national academy of medicine as "crisis standards of care," defined as the "optimal level of care that can be delivered during a catastrophic event, requiring substantial change in usual health care operations." in jurisdictions with declared public health emergencies, crisis standards of care provide a mechanism for reallocating staff, facilities, and supplies to meet population needs. to free up scarce medical resources, for example, hospitals could postpone nonemergency tests and procedures. in the areas hardest hit so far, like seattle and new york, hospital administrators have been canceling or postponing electiveand even some more serious -surgeries. to avoid harm, health agencies and organizations must plan now to implement crisis standards of care; they should not wait until the disease is widely detected in the community. implementing crisis standards must be part of a systemwide approach in which all stakeholders, including health professionals and the public, participate in transparent decision-making. how can we ethically allocate scarce resources? even with increased production and measures like postponing nonurgent medical procedures, there might still be too few health workers and critical care beds and not enough supplies and equipment. these resources must be allocated ethically. first and foremost is the need to protect health workers delivering care in the midst of the crisis, for without them and their extraordinary efforts, the entire health system would collapse. along with ensuring that health workers are adequately trained in infection control, supplied with protective equipment, and provided vaccines once available, the health system should designate health workers a top priority for receiving scarce resources that are vital for their own protection, care, and treatment. second, beyond health workers, decisions about who is tested or who receives treatment must center on prevention of sars-cov- transmission (public health), protection of individuals at highest risk, meeting societal needs, and promoting social justice. protecting public health may mean prioritizing resources for people in confined settings (such as homeless shelters, prisons, and nursing homes), where the virus can spread rapidly from person to person. resources may need to be targeted to areas experiencing localized outbreaks to curb transmission and prevent hospitalizations. groups at highest risks, such as older adults, people with compromised immune systems, and people with underlying conditions (such as heart or lung disease or diabetes) are another priority, as they are most likely to become seriously ill and die. meeting societal necessity means protecting critical services, like public safety, fire protection, and sanitation, as well as producers and suppliers of essential goods and services, like food and medicine, as well as people who carry out critical public health functions. even with mass closures during covid- , these services must continue, and people working in these areas should be priorities as well. finally, social justice demands that needed supplies and countermeasures are distributed equitably, with steps to ensure that poorer and marginalized populations-segments of the population traditionally left behind, like people with disabilities and people of color-receive a fair distribution of scarce resources. in addition to identifying specific groups that need special care, ethical distribution requires a fair process in deciding. to the extent possible, decision-making about the allocation of scarce resources in response to covid- should include the public and be made in advance, and it must be transparent and based on clearly explained rationales that are grounded in scientific evidence related to transmission of the virus, morbidity and mortality, and other relevant considerations, such as those delineated above. fair distribution is not only a national issue. globally, lower-income countries will face much more scarcity than wealthier states and, if covid- takes hold, a higher burden of disease. the united states is ethically obligated to assist-even if this means reducing american stockpilesto maximally protect and equally value all human life. vitally needed supplies like personal protective equipment and, when available, vaccines and treatments, must not be hoarded by wealthier countries or the countries where they happen to be manufactured. this is a matter not only of ethics but also of ensuring americans' health. even if we get covid- well under control in the united states, new outbreaks here will be all but inevitable unless other countries do so as well. imagine the global political fallout if mil-lions of people died in sub-saharan africa, while availability of an effective vaccine saved those living in north america and europe. access to the health system: protecting the most vulnerable h igh costs, fear of discrimination, and fear of deportation can make covid- testing and treatment inaccessible for vulnerable populations, including under-and uninsured persons and immigrants, and this lack of access implicates both health and justice concerns. governments must assure that covid- testing and care, and vaccines and treatment once available, are free so that cost does not cause anyone to delay or avoid care. health facilities should be enforcement-free zones for undocumented immigrants, spaces where they will not face any risk of being detained or deported. further, hospitals and health departments must have staff members trained in and responsible for communicating with people who do not speak english or are members of vulnerable populations, like refugees and undocumented immigrants and those with impaired hearing or vision. special measures may be necessary to ensure that vulnerable populations have access to health care and can practice good hygiene. for example, public health agencies should provide supplies of hand sanitizer or hygiene kits to shelters and outreach workers to distribute to people who are homeless for use throughout the day. and authorities could direct or incentivize businesses to permit people who are homeless to use their toilets and washing facilities. a mple evidence shows extreme covid- risk in congregate settings such as cruise ships, nursing homes, prisons, churches, shelters, and dorms. in washington state, at least twenty-seven covid- deaths are linked to a single nursing home. physical distancing measures, including closing public spaces (schools, childcare, workplaces, mass transit) and canceling public events (holiday celebrations, religious ceremonies, sports events, political rallies), are becoming widespread and could help reduce viral spread if they are implemented smartly, scientifically, and ethically. in this unprecedented period of social separation, loneliness, emotional detachment, and disruptions to social and economic life will produce profound harms. vital cultural practices such as faith-based services, family bonding, and social connectedness are vanishing from public life. we are also witnessing something all too common in disease epidemics-blaming "the other." racial and ethnic discrimination, in this case against people of asian, and especially chinese, descent, may result from the spread of misinformation or sheer ignorance. governments must be prepared to address these harms. protecting the most vulnerable among us. sacrifice is necessary, but it must be part of a fair social compact: people should adhere to advice or even mandates for physical distancing, but governments, in turn, must ensure that their needs are met. for the well-off, with well-stocked pantries and generous telework or paid leave, staying home may be feasible. but for poorer families and individuals, physical distancing can be harmful if they are cut off from sources of income, assistance, and support. once out of work, individuals may not be able to afford necessities like food, housing, and medicine. with many schools closed across the united states, parents without paid family leave will struggle to find childcare and to provide meals that children would normally receive at school. for people who are elderly or with physical or mental disabilities, ordering food online or going to the grocery store can be difficult or impossible. where compliance with physical distancing is directly at odds with meeting basic needs, societal harms are inevitable and must be mitigated. governments must provide wraparound medical care for the under-and uninsured and meet essential needs like medication, food, and water. if schools are closed, leaving low-income children without school breakfasts and lunch, authorities should arrange for children and families to receive food at home. paid sick leave should be afforded to people temporarily out of work due to quarantines, isolation, business closures, or lack of childcare. people with disabilities and their caregivers should receive funding to ensure that their needs are met and to cover extra costs, such as for home delivery of food and other necessities. if americans are doing their part to stay home and prevent covid- transmission, government must do its part, too. that is an essential part of the social bargain. further, physical distancing may be very difficult in some places, such as in prisons, detention centers, homeless shelters, and nursing homes. we must protect against disease outbreaks at these sites, including ensuring good medical care, sanitary facilities, and good hygiene (such as ample supplies of soap and hand sanitizer). large-scale and immediate use of compassionate release programs can protect we are all only as safe as the most vulnerable among us-both in the united states and globally. equity and public health go hand and hand. nonviolent prisoners, especially if they are elderly or vulnerable, without compromising public safety. other action will be needed, too, to prevent prisons and jails from becoming hotbeds of infection. such actions might include releasing people with electronic monitoring (allowing for freedom of movement), releasing people who are jailed simply because they cannot pay bail, and reducing arrests and delaying sentencing. those who have underlying medical conditions might be particularly good candidates for these measures. some, like people who are at low risk of reoffending, might simply be released. and the government should enable people who are homeless and currently unsheltered to have safe shelter, whether procuring hotel rooms or developing emergency shelters designed to enable physical distancing. informed and trusted communication. physical distancing policy must go hand in hand with informed and transparent public communication strategies. a trusted source of information must inform the public about known risks, unknown risks, and what steps are being taken to learn more. the public must be assured that their basic needs will be met and that strategies to mitigate harms, such as online instruction for elementary and secondary schools and broadcasting religious services, will be available. the public must be properly informed about good hygiene practices that can help prevent covid- 's spread-and about how they can access hygiene products. isolation, quarantine, cordon sanitaire, and physical distancing g overnments seeking to limit the spread of covid- may isolate sick individuals, quarantine exposed individuals, and institute cordon sanitaire. isolation and quarantine were widely used in asia and canada during the sars outbreak, but their effectiveness depends heavily on outbreak stage and viral transmission characteristics, which are not yet fully understood for sars-cov- . these measures, where known or expected to be effective in reducing viral transmission, can be lawful, but infringements on individual privacy and liberties must be carefully considered. balancing public health and civil liberties. quarantine, isolation, and cordon sanitaire are extreme measures that entail stringent restrictions on freedom of movement, association, and travel and can cause massive economic and social disruption. when balanced against public health interests, a basic rule is that governments should employ the least restrictive means necessary to protect public health. meeting this standard requires that any covid- isolation, quarantine, and cordon sanitaire must be based on rigorous scientific assessment of risk and effectiveness. quarantine and isolation for covid- should be ordered only if the person is known or highly suspected to have been exposed to the disease, and only for the maximum duration of incubation (fourteen days for covid- ). procedural due process requires that a person has proper notice and an opportunity to challenge a containment order, where feasible. further, individuals subject to isolation, quarantine, or cordon sanitaire orders must be assured a safe and habitable environment. especially in large-scale quarantines, there could be challenges to ensuring safe and hygienic locations, medical and nursing care, necessities like food, water, and clothing, and communications. vulnerable populations must be protected; authorities should identify in advance those who may need extra assistance (such as older people and people with disabilities) and develop plans to meet their needs. above all, containment measures must not be a subterfuge for discrimination. deciding how far governments should go. compulsory orders for quarantine, isolation, and cordon sanitaire bring enormous legal, ethical, and logistical challenges and should be used only as a last resort. self-isolation or self-quarantine are preferable and generally effective. when properly informed, most people will follow their instincts to stay safe and will shelter in place at home. self-isolation has another benefit besides limiting infringement on people's civil liberties: if hospitals become overwhelmed, as in south korea and italy, self-isolation for people with mild symptoms can help make more hospital beds available for sicker patients. where voluntary compliance is not an option, governments may need to enforce containment orders in the interest of public health, but how far should they go? it may be relatively easy to enforce isolation and quarantine orders against individuals who pose a known danger. yet we are witnessing large-scale quarantines imposed without any individualized risk assessment. elderly persons, for example, face such a high risk of death if they contract covid- that many nursing homes have gone on "lockdown" mode, forbidding residents to leave or visitors to enter the facility. as described above, these orders must follow rigorous safeguards, including opting for the least restrictive alternative, depending on scientific assessment of risk and effectiveness, ensuring procedural due process, and providing a safe and habitable environment. difficult questions will still arise, though. for example, are complete lockdowns necessary, or may an eighty-year-old without underlying conditions go for a short walk outside while practicing physical distancing? further, monitoring and enforcement through surveillance modes, including thermal scanners, electronic bracelets, and web cameras such as those used during the sars outbreak, implicate privacy interests. enlisting armed police and citizen informers to control large populations in cities like new york or chicago seems so contrary to american values and the rule of law that it is difficult to conceive opting for that route in the days and weeks ahead. but san francisco has already ordered its population to shelter in place for three weeks, with people directed to stay inside and avoid contact with others, though with numerous exceptions. people can leave their homes without government permission, but law enforcement has been asked to ensure compliance. at a time of vast inequities, we are all only as safe as the most vulnerable among us-both in the united states and globally. if poor or disadvantaged members of our community cannot practice physical distancing or access health services, then we will all be at greater risk. conversely, those who are better off should take measures to protect themselves from infection, both for their own health and in order to protect everybody else. equity and public health go hand and hand. we are in uncharted territory, where vital human connections and economic activity are disrupted in ways not seen in generations. if we want to safeguard the public's health while being faithful to our most fundamental values, then we must ensure that our response is effective, ethical, and equitable. presidential powers and response to covid- effects of the west africa ebola virus disease on health-care utilization-a systematic review a framework for catastrophic disaster response ethical framework for health care institutions and guidelines for institutional ethics services responding to the novel coronavirus pandemic duty to plan: health care, crisis standards of care, and novel coronavirus sars-cov- ," a discussion paper institute of medicine, committee on guidance for establishing crisis standards of care for use in disaster situations, crisis standards of care: a systems framework for catastrophic disaster response pandemic influenza: public health preparedness for the next global health emergency pandemic influenza: public health preparedness for the next global health emergency covid- : who is protecting the people with disabilities?-un rights expert," press release pandemic influenza: public health preparedness for the next global health emergency key: cord- -h wj m u authors: keil, roger; ali, harris title: governing the sick city: urban governance in the age of emerging infectious disease date: - - journal: antipode doi: . /j. - . . .x sha: doc_id: cord_uid: h wj m u abstract: based on a case study of the severe acute respiratory syndrome (sars) outbreak in toronto, canada, this article suggests that we may have to rethink our common perception of what urban governance entails. rather than operating solely in the conceptual proximity of social cohesion and economic competitiveness, urban governance may soon prove to be more centrally concerned with questions of widespread disease, life and death and the construction of new internal boundaries and regulations just at the time that globalization seems to suggest the breakdown of some traditional scalar incisions such as national boundaries in a post‐westphalian environment. we argue that urban governance must face the new (or reemerging) challenge of dealing with infectious disease in the context of the “new normal” and that global health governance may be better off by taking the possibilities that rest in metropolitan governance more seriously. avian flu has begun to capture the imagination of world publics in recent years as the h n virus spread from its perceived origin in east and southeast asia to turkey and potentially to western europe (davis ) . newspapers and television corporations have discovered the pandemic as a topic of interest. governments, businesses, and civic organizations at all scales have drawn up preparedness plans. this newfound interest in the threat from emerging infectious disease has a recent precedent. in the spring of many parts of the world experienced an outbreak of severe acute respiratory syndrome (sars). in many ways, the sars outbreak is now being read as a stage rehearsal for what many public health experts believe will be a much larger epidemic once the h n virus, which has so far only spread from infected birds to humans, mutates and leads to direct human-to-human infection. sars, a previously unknown disease, is much different from h n but the way it was handled by health authorities around the globe can potentially teach us some lessons about future pandemic preparedness. this article looks at the urban governance aspect of these urban governance in the age of emerging infectious disease lessons. we rely on the rich and productive output in urban governance studies but will argue that this literature has had a particular blind spot: the relationship of urban governance restructuring to emerging infectious disease (eid). urban governance must be prepared to deal with infectious disease. at the same time, global health governance overall may be improved by realizing the possibilities that rest in metropolitan governance. a new "post-westphalian" constellation of post-national state power (fidler ) poses previously unknown demands on the governance of urban regions in the area of infectious disease control. while there has been much attention in recent years on the significance of global city regions in the new world economy (brenner and keil ) and while the governance and regulation of these regions has captured the imagination of academics and policymakers alike (buck et al ; harding ; heinelt and kübler ; kantor and savitch ; scott ) , little has been said specifically about the growing pressures posed by the potential threat of infectious disease through the global network on urban governance. rather than operating solely in between the often contradictory challenges of social cohesion and economic competitiveness, urban governance may soon have to be more centrally concerned with questions of widespread disease, life and death (agamben ) and the construction of new internal boundaries and regulations just at the time that globalization seems to suggest the breakdown of some traditional scalar incisions such as national boundaries. in making connections between the traditional discussion of public service provision between competitiveness and cohesion and the more dramatic and urgent questions about disease and health, life and death, we also consult work that has-in a foucauldian mannermore directly engaged with issues of (bio)power and governmentality (osborne and rose ; rose ) . for the area of urban planning and governance a more or less critical literature has begun to explore the spaces that cities have to maneuver in the rather open field of infectious disease preparedness planning and public health since the onset of the "new normal" after the attacks of / malizia ; matthew and macdonald ) . some work has explored the historical precedents of variations in how cities have fought infectious disease in order "to help us plan for the battles against disease that will be part of our future" (leavitt : ) . howard markel has put forward the observation that "[n]othing less than a cooperative partnership of nations, healthcare professionals, researchers, public health specialists, concerned corporations, philanthropies, and individuals will suffice to safeguard the world against the many public health problems we face today" ( : - ) . still, we believe more specific work needs to be done clarifying and determining the role municipal institutions of health governance can play in the global system of health governance. it is possible to view the sars outbreak of as a direct consequence of increased connectivity due to globalization in general and advances in transportation technologies in particular (brockmann, hufnagel and geisel ; guimera et al ) . in order to understand the effects of connectivity in the global city system on the health of people in these cities, it is necessary to develop new and innovative ways of thinking about what is connected in what ways in that system . there is a strong and growing consensus in the literature on globalization and health/disease that realities in a post-westphalian world need a rethinking of governance structures on a variety of scales between the global and the local (ali and keil forthcoming; fidler ; gandy b; harris and seid a; knobler et al ; lee ; markel ; mclean et al ; whiteford and manderson ) . in this article, we ask what the consequences of the connectivity for health governance will be. although public health policy delivery has always been an intensely local process, the "westphalian" state system had defined health policies in national containers ordered and segmented among others by world health organization guidelines but mostly under the sovereign jurisdiction of nation-states. public health was national health and health policy was national health policy under this regime. who interventions had to occur in the framework of national sovereignties, whose concern was with both popular health and economic welfare-not necessarily in this order (fidler ; heymann ; heymann interview, geneva september ) . when sars hit major metropolitan regions in asia and north america the need to rethink both global and sub-national health governance was exposed. the reliance on the hierarchical and hermetic system of nationally based health policy was put to the test as the who attempted to carve out a novel activist role in protecting global health beyond national interests and as sub-national governments, economic and civil society players moved to react to a localized global health crisis with coordinated action of their own (abraham ; fidler ) . at both ends of the redefinition of international health governance-the local and the global-an "institutional void" (hajer ) existed which could not be filled automatically by traditional, national health governance institutions and their international affiliates. we posit that urban governance will increasingly have to deal with questions of vulnerability and risk related to eids. vulnerability to eids is perhaps more pronounced in urban areas, where the majority of us live. urbanization increases the statistical odds that microbes are being spread (pennington ) . the aggregation of human populations into highdensity urban "islands" has important effects in providing the host reservoirs for maintaining infection chains (haggett ) . accelerated land use changes in and around urban areas have heightened the vulnerability of urban populations to infectious disease (patz et al ) . vulnerability is a notion which in close proximity to other "essentializing" western discourses such as tropicality and development (bankoff ) . it refers to a state outside of the west. yet, the notion of vulnerability has taken on renewed significance after september , particularly in the usa, as the "sense of security of many american citizens" was punctured (simon : ) . it has particular relevance to the case of sars which shattered the local public health and hospital systems of toronto, hong kong and singapore and the public perception of their safety. these cities' "globality" means that an infectious disease cannot be contained by a purely exclusive "local" strategy of public health. most vulnerability reduction policies tend to be largely limited to making safety modifications to key buildings and critical infrastructures, but the sars case illustrates that the human/cultural dimension must also be considered in the effective management of disease outbreaks in the contemporary global city. thus, isolation and quarantine did appear effective in fighting the outbreak, but what more could be done to prepare such containment strategies in case of future outbreaks in the global city? it is clear that we need to better understand the interactions of local modes of healthcare regulation in a globalized urban environment and the specific dimensions of urban vulnerability to public health threats in the global city setting (d'cunha (d'cunha , . global cities are usually considered a specific category of urban centres. they often have more to do with each other than with their immediate hinterlands and regions, and they tend to be more like other global cities than like other cities in their national networks (for an overview of the literature, see brenner and keil ) . as the case of sars demonstrated, global cities are not just switching stations for flows of capital and labour allegedly ordered in a tight network of privilege and command functions. they also are transfer stations of various and contradictory dynamics of the globalized economy. among them are city-country relations, connections between the developed and the developing world, even human-animal interrelations (brenner and keil ; sassen ; taylor ) . the sars virus is said to have travelled to toronto from hong kong through a chain of connectivities-or to use another term, an actor network-that includes the civet cat, live ("wet") animal markets, cross-border commuters across the spectrum of the labour market, hotels, transnational travellers, airports, healthcare workers, hospitals, etc. contributing factors were faulty or badly maintained aeration and plumbing systems in high-rise buildings, air travel in hermetically closed airplanes, hospital systems, diasporic relations among relatives, and so forth. at each link of this rather disparate chain, sub-connectivities are present, which we have called the capillaries of the global system: family relationships, small and parochial religious communities, more or less isolated (and even criminalized) food-handling practices, hospital hygiene codes, etc, all sub-realities of a larger global network of relationships. these subrealities are often not accounted for in descriptions of global cityness although they seem to be central to our understanding of certain consequences of globalization, such as the spread of eids. they are not just the micro versions of larger macro processes constituted elsewhere: they are co-constitutive of the global realities themselves. insofar as they belong to the larger processes of metabolism, these sub-realities are part of the ecological substrate of the global city system. we argue that it is exactly the dialectics of fixed infrastructures, built environments, institutional arrangements, reliable legal constructs, functioning hospitals (and their governance arrangements) of global cities on one hand and the unfixed, mobile, constantly re-articulated flows of people, non-human organisms, information and things that move through them, on the other. recognizing this dialectic also implies the critique of functionalistic and technological images of global connectivity in fixed network nodes. we rather postulate the topological, agency-founded co-constitution of such nodes gandy a; smith ) . urban governance has become a standard phrase in urban political studies. following jon pierre, urban governance can be defined as "the pursuit of collective goals through an inclusive strategy of resource mobilization" ( : ). as the focus of urban scholars has moved from "the comparative study of constitutions and city charters" to decision-making processes that involve state, market and civil society actors in all areas (gissendanner : ) , a broad spectrum of urban governance research has now been produced with case studies, comparisons and further theoretical developments (see, for example, brenner ; elwood ; harding , forthcoming; heinelt and kübler ; kantor and savitch ; kaufmann, léautier and mastruzzi ; pierre ; sellers ) . north-america-centred work on urban regimes, which continues to produce excellent case and comparative studies (for a recent summary of this literature see stone ) is complemented by a strong european-centred body of work of mostly comparative nature (brenner ; buck et al ; legales ) . in some of the literature, the shift to governance has been discussed in relation to the globalization and neoliberalization of cities, processes which in many cases have been seen as causative of this shift (brenner and theodore ) , while other authors have emphasized the role governance has itself played in facilitating these processes in turn. the comparative literature on urban governance restructuring has various intersections with the rescaling of the "political pathology" of infectious disease containment (fidler ) as the global and neoliberal contexts of current restructuring at the urban scale have been the focus of much theoretical and conceptual work. of these intersections, the new focus of metropolitanization deserves our specific attention. brenner's central concern, for example, is with the ways in which "urban governance has served as a major catalyst, medium, and arena of state rescaling processes" ( : ). new collective action at the city-regional level in the many traditional (e.g. economic development and social welfare) and emerging (e.g. environmental, (multi-)cultural) policy fields can be discerned in metropolitan areas around the world. public policymaking increasingly occurs at the metropolitan level as municipal and regional elites deliberately nurture this scale as the basis for international competition (boudreau et al forthcoming; brenner ). yet, there is also an emerging political space at the metropolitan scale, where collective action and claims for local democracy unfold. metropolitanization can mean an internal reconstitution of the political sphere and its articulation with civil society: "there is a diversification of local responsibilities and activities, from the production of local services to, among other things, a proactive role in economic development" (boudreau et al forthcoming) . among these responsibilities and activities may also be health governance at the urban scale. there is ample scholarship on the historical relationship between municipal government and disease both historically and on recent developments, such as the reemergence of tb, the role of urban poverty and diversity vis-à-vis disease or the ravages of aids (see, for example, craddock ; gandy and zumla ; raphael ; shah ). yet despite an increased interest in the relationship of globalization and disease (mcmurray and smith ), there has not been much attention on the specific urban governance aspects of eids in a world characterized by globalizing and global cities. we will argue accordingly that in the face of new threats to the health of urban dwellers caused both by increased technological, economic, cultural and ecological connectivity (globalization) and healthcare restructuring (neoliberalization), we need a renewed focus on the city as a place of potential or real disease and inversely as a place of health. an exception to the dearth of work conceptualizing health and disease as part of the overall governance of world cities has been the research of victor rodwin and michael gusmano ( ) on public health infrastructure in new york, london, paris and tokyo. while not explicitly locating their work in the governance literature, rodwin and gusmano ( : ) have noted: "urban health evokes contrasting images: the city as a center of disease, poor health, and enduring poverty versus the city as a cradle of historical public health interventions, innovative medical cures, and healthy lifestyles for the well-to-do". studying "urban health, particularly the evolution and current organization of public health infrastructure and the health status and quality of life in these cities" and the "important links between local, subnational, and central or federal authorities" (ibid: ) sounds familiar to students of urban governance. rodwin and gusmano have shown the impact of global cityness on localized health governance mechanisms and systems. in their work on new york, london, paris, and tokyo, rodwin and gusmano ( : ) have examined the impacts of "world cities-their health system and neighborhood characteristics-on two outcomes: the use of health services and health status". they found, not surprisingly perhaps, great diversity in which health is factored into the overall global city formation in these four leading global urban centres. their ongoing studies on various aspects of the public health system in these cities reveal the connections between common structural inequalities and social problems in global cities with their health systems. this work fills a void in the research on global cities generally and specifically adds to our understanding of the impact of globally induced social inequality-ie global city formation-on health. it also has the added benefit of being able to help us differentiate between the various health governance systems in cities as diverse as london, paris, new york and tokyo both in their centres and peripheries. rodwin and gusmano have identified four distinct "onerous health risks", which global cities such as toronto, hong kong and singapore confront: the re-emergence of infectious diseases; rising inequalities among social groups; barriers in access to quality healthcare by ethnic minorities and/or the poor; and terrorism and bioterrorism ( : ). all four themes stretch the notion of the city as a defined territorialized place. they point to cities as sites of topological relations that articulate activities and dynamics at various scales (amin and thrift ) . they define, to a large degree, the agenda of global city health governance. yet, as much as rodwin and gusmano's own research sheds light on the place-related aspects of health, it does not itself deal with the network-related aspects of health which is the aspect emphasized in the current article. we suggest adding two important dimensions of the analysis which we believe increase our understanding of the role of urban health governance in the fight against eids. first, the governance of cities today is unimaginable without the modern constitution of the "bacteriological city" at its base (gandy a, forthcoming) , which created managerial processes of a technological, engineering and scientific nature to guarantee public health and to lay the foundation of an economic development and demographic growth ostensibly unencumbered by the incalculable onset of disease outbreaks, which had wrecked urban populations and their economies until the twentieth century in europe and north america. it is on the basis of this century-old history that we now need to rethink urban health governance. a historical process of purification separated the modern city from its natural environments through a set of infrastructures and mechanized metabolic processes such as water and sewer infrastructure, garbage collection and processing, etc (kaika ). the "bacteriological city" as matthew gandy ( gandy ( , a has called the city of the twentieth century, was based on an entirely human-centred purified science, which "othered" animals, externalized disease and-in extreme caseseliminated "less-than-human" humans through technical ingenuity and government biopolitics (foucault ) . the bacteriological city kept the germs in check and allowed for new types of socially cohesive urban relations to take shape: "the emerging 'bacteriological city' involved a medley of different social, political, economic and environmental goals set within the context of a movement away from fragmentary and laissez-faire approaches to urban governance" (gandy : ) . this rationalization of urban governance via technologically reliable networks was based on a universalist interest in public health advances. the currently popular "neoorganicist" view of the city, of which the materialist notion of the cyborg city is a critical extension, puts a new spin on the tradition of the bacteriological city. it has been strongly associated with a transhumanist view of our urban reality, in which, as bruce braun observes, "'barely human' others (iraquis, rwandans, muslims), and 'almost human' companions (monkeys, dogs and cats), are discussed alongside accounts of 'inter-species' exchange (bird flu, sars) in which the boundaries of the human are suddenly porous and mobile" ( : ). such mixing clearly has consequences for governance as the carefully guarded distinctions between people and germs, materialized in the modern bacteriological city, are now being challenged unexpectedly. as a consequence, we now need to figure out collectively where to draw the kinds of regulative boundaries, which we humans may need to survive the imagined or real onslaught of the germs. and such defensiveness is most likely tied up with the regulation of bodies-human and nonhuman-that carry or are suspected to carry the disease. technically, while not necessarily ethically, the sacrifice of millions of ducks or cattle as a reactive of preventative public health measure, is the same kind of measure as airport screening for foot and mouth disease and sars and quarantine of suspected bodies in cities. braun challenges us to think that it is: possible to understand cities, for example as "posthuman" assemblages in ways that both vastly expand our understanding of the actors shaping the urban experience, and that confound our usual understandings of the space and time of urban life . . . writing the sars virus into a "posthuman" toronto explodes the time-space of the city, folding people and animals in china and thailand into bodies on queen street, and revealing time to be multiple and rhythmic-the time of circulation of people and capital but also molecules ( : ). lastly, disease and health have important impacts on the rearrangement of the governance of public/private space. hospitals, quarantine, cultural spaces are fundamentally reassessed and their place in the order of public and private everyday lives and official geographies is recalibrated: what is acceptable in terms of use of space by various bodies in cities? our argument is that while purification and biopolitics were the characteristics associated with the hygienic city of the last century, we have now entered a phase in which the potential reemergence of infectious disease at a mass scale forces us to rethink the relationship of our built environments, our institutional arrangements and our practices as urban dwellers. this has to do as much with the changing nature of cities as basing points of the global economy-to use quite a conventional concept from global cities theory-as with the kinds of reemerging diseases we now have to deal with. second, it is necessary to extend our view beyond the national institutional level when looking at the governance of eids in cities, as extra-national organizations such as the atlanta centers for disease control (cdc) and supra-national organizations such as the world health organization (who) exert significant influence on urban health governance in any country, sometimes not even mediated through national policy or institutions (fidler ; heymann ) . in a global perspective maarten hajer has noted a particular "institutional void": [m]ore than before, solutions for pressing problems cannot be found within the boundaries of sovereign polities. as established institutional arrangements often lack the power to deliver the required or requested policy results on their own, they take part in transnational, polycentric networks of governance in which power is dispersed. the weakening of the state here goes hand in hand with the international growth of civil society, the emergence of new citizen-actors and new forms of mobilization ( : ). municipal public health policy emerges in a context of larger-scale dynamics over which it has little control. global cities and city-states such as toronto, hong kong and even singapore are burdened with responsibilities due to their rising integration into world city networks on one hand and continued lack of self-determined decision-making powers for their complex jurisdictions on the other. in addition, cities like toronto are tied into an increasingly diverse global network of diaspora and migrant cultures at the base of their hybrid globality (goonewardena and kipfer ) . the connection between the globalizing political economy and the cultural and demographic changes it brings with it are crucial to understanding the everyday practices and socio-cultural interactions that characterize today's world and more specifically the everydayness of global cities. toronto-like other cities in the global city network and elsewhere-has taken on far-reaching responsibilities for the settlement of immigrants. this has become a central concern of metropolitan governance now. as in past waves of immigration, cities have become the actual border points for new immigrants. it is important to remember, as nicholas king has reminded us, that under these circumstances, "researchers and public health officials would do well to think in transnational as well as international terms. this means focusing less on the transgression of borders by individuals, and more on the formation of transnational connections between spaces and populations once thought to be disconnected or insulated from one another" ( : ). of course, urban governance is just a fraction of an overall system of health governance, which in the words of fidler ( ) now has to deal with sars as the "first post-westphalian pathogen". fidler also reminds us that as sars represents new problems for public health and creates the need to develop diagnostics, treatments and vaccines in the context of globalization, it breaks down both the sub-national and international framework in which public health has been governed for more than years. in particular, the sars outbreak posed a threat to commonly held views of national sovereignty which allowed nationstates to deal-vertically-with their own health systems internally while negotiating (ideally) at par-horizontally-with other nationstates internationally. the experience with sars points to an interesting dialectics: the existing system is both corroded and withstands the onslaught of the virus. speaking about the us, fidler states, "federalism constructs political borders between federal and state governments. germs no more recognize these borders than they recognize international borders. federalism does not, however, disappear as an influence on public health governance simply because germs do not recognize the boundaries it creates" ( : ). fidler's "political pathology" is pivotal for the understanding of the parameters of health governance today. he carefully charts the landscape of international and now global health governance since the nineteenth century, when the first international sanitary regulations were drawn up among the great powers of the world. these efforts eventually led to the creation of a world health agency, the who, which has operated on a set of tenuous global regulations such as the international health regulations, which have recently undergone redrafting to reflect the specific challenges posed by the fight against sars (fidler ) . the weakness of fidler's otherwise sharp analysis is that it focuses only on one direction of the rescaling of international health governance towards the global level. in answering the question "how to manage borderless bugs in a borderless world", fidler concentrates on the role of new global institutions as well as new non-state actors in the health field. both, he correctly states, narrow the traditional sovereign spaces of health policymaking, even of large states such as china which-begrudgingly-ceded some of its authority to the who during the sars crisis after initially lying to the world about the severity of the disease in its provinces and in the nation's capital. the who emerged as a stronger and more recognized player from the sars crisis and established, for the first time and if only briefly, a global community of eid management (fidler : ; heymann ; preiser ). fidler does not engage with other forms of the rescaling of the westphalian state system such as the one brenner has defined as "metropolitanization" (brenner ) . we have been arguing throughout this article that this metropolitan scale of governance deserves more attention in the regulation of an urban-based global reality. in fact, as the former director general of the who underlined, "who officials every day deal with local communities and officials, around the world" (brundtland, email interview november ). although, in the past, cities have often been directly blamed or linked to disease (gandy : ) , this pattern was supposed to have been superseded by the modernity of the cities themselves. until not too long ago, cities in the west were considered free of catastrophic disease of the traditional epidemic kind. thomas osborne and nikolas rose noted only as recently as that we could observe a shift from a focus on disease to a focus on health in the governance of cities: the city has long been imagined in terms of sickness and health. but in recent decades a new image of the healthy city has emerged: the city as a network of living practices of well-being . . . the very idea of disease in the city has been transformed. it is no longer imagined in epidemic form-the invasion of the urban milieu by cholera or typhus putting its inhabitants at risk of infection. rather, disease and ill health more generally, is imagined in terms of activities (diet and coronary heart disease . . .) and relationships (unsafe sex and hiv . . .). we no longer have the sick on the one side of a division, the healthy on the other-we are all, actually or potentially, sick, and health is not a state to be striven for only when one falls ill, it is something to be maintained by what we do at every moment of our everyday lives ( : - ). recent developments in the wake of sars but also scenarios following a potential outbreak of an epidemic of either a new flu strain or a human form of the avian flu have belied the disappearance of epidemic disease from the urban experience as expressed in this quote. not only is it not true for most cities in the world where people keep being threatened by infectious disease pandemics of all kinds, it is also not true for western cities anymore as sars has shown in utmost clarity. we do agree with osborne and rose, though, when they point out that the governmentality that regulates disease has shifted from the collective to the individual. this is a major biopolitical shift which is mostly played out on the level of urban governance. this interpretation coincides with other work on the changing nature of public health (petersen and lupton ) , which argues that health and disease have been recast as individual responsibilities rather than social ones in the contemporary period [see also sanford and ali ( ) for an elaboration of this argument with respect to sars]. it is exactly this-neoliberalgovernmentality of individualized notions of health and sickness which existed when sars arrived. it is in this framework that we have to understand the new thinking and agency around infectious disease in the city. it adds to the general shift in the current city from traditional notions of control in favour of a more clearly orchestrated mix of state and market interventions. public health governance in the age of sars has-at least potentially-moved to a bundle of strategies that fit well into the overall securitization of urban society which includes "enhanced forms of social control through a mix of architectural, ideological and intelligence-gathering processes" (gandy a: ) . in addition to these developments towards a new governmentality of public health, the sars crisis occurred in a very specific environment, which had been created by the events that followed the attacks on washington and new york city on september , . shortly after september , , american vice president dick cheney was reflecting on what he called a "new normalcy", a notion that was used widely at the time to legitimize changes to long-held understandings of the social and legal makeup of american society (lawyers committee for human rights ). legal scholars and practitioners as well as political pundits and activists of all stripes pondered the meaning of the "new normal" and pointed to the deterioration of basic human and civil rights in the aftermath of the september and subsequent war-related events. "living" in the "new normal" became an object of serious study (simon ) . a legal study examined such changes in the areas of "government openness; personal privacy; immigration; security-related detention; and the effect of us actions on human rights standards around the world" (ibid). while admitting to the necessity of some government action in the wake of / , the report notes "dramatic changes in the relationship between the us government and the people it serves" and voices many grave concerns about the deterioration of civic and individual liberties. beyond its immediate denotation with respect to the changing times after / , the term has since thrived as a powerful (if somewhat clichéd) metaphor that has been bandied about in all kinds of contexts. and despite the clearly problematic context in which "the new normal" was introduced into the political and vernacular vocabulary-or perhaps precisely because of the implications of this context-the term found a wide use in toronto's sars outbreak of . during the crisis politics of the day, particularly in the healthcare system itself and among the politicians involved, "the new normal" quickly became the buzzword for an overall state of emergency that gave policy actors and decisionmakers license to make unprecedented changes and to call for reform of major threads of the social fabric, particularly in the area of public health. the "new normal" became the umbrella term for a situation in which thousands were put into quarantine (or if they resisted into isolation), and nurses-many of whom were infected themselves-were missing from understaffed hospitals, at a time when the overall system of healthcare delivery was admittedly about to "snap" (boyle ) . one of the main users of the concept was the ultra-conservative minister of health for ontario, tony clement, who, for a moment, surfed on the popular wave of the giuliani-brand "roll-up-your-sleeve" and "openshirt-collar" politics of emergency, which swept him into the public spotlight in the spring of . clement became the public face of a social crisis which had repercussions for much more than health policy per se, and touched on issues involving labour relations, "race" relations, multiculturalism and much more. the "new normal" soon became the yardstick for all these types of issues. for instance, in a dispute with nurses about the lack of full-time positions and the potential change to the funding formula, clement said on may : "in the 'new normal' those kinds of things would have to be reviewed through the prism of infection control". around the same time, clement's ministry issued a "backgrounder" in which the "new normal" was "characterized by high standards of practice that reflect a heightened awareness of emerging infectious diseases including sars" and where there is mention of a "'new normal' environment", in which healthcare workers are meant to operate. one set of directions for the faculty of medicine at the university of toronto dated june , stated self-reflexively: the term "new normal" has already become a bit hackneyed in the face of a second wave of sars in toronto. nonetheless, it is a useful term to encapsulate the change in thinking that may be necessary if we are to achieve longer-term containment of sars and any similar illnesses that may come at us in the future (http://www. library.utoronto.ca/medicine/sars/sarsupdate.pdf; emphasis in the original). at other scales, a toronto family doctor, for example, used the term in a "sars diary" she published in a professional journal and concludes, after relating her ordeals of operating under conditions of quarantine: "i guess this is the new normal i've been hearing about" (greiver ). yet another voice was the director of the reputed american centers for disease control in atlanta, julie geberding, who referred to diseases like sars and monkeypox as the "new normal" while addressing a meeting of the american medical association in chicago in . the connection of the "new normal" to state protocol in its dealing with citizens in an anti-terrorist effort is neither surprising nor unintended by those who make the link. the very notion of the "new normal" signifies the intrusion of unusual measures in our everyday lives, in which leaders have to be cut slack in making decisions about political rule, when regular law and understandings of rights become irregular or non-normal. the invocation of legitimized state violence-be it in anti-terrorist war or in imposing quarantine on groups within an urban community-through the concept "new normal" is itself becoming an accepted part of what we consider tolerable. the "new normal" changed both the horizon of expectation, which citizens, users of the healthcare system, travellers, etc may have had and the potential range of action for governments in dealing with the crisis. it has led, at a remarkable rate, to a lowering of democratic potential in the making and practice of policy, in this case health. the rights of both patients and healthcare workers were considerably cut back during the toronto sars crisis. this is true precisely because the crisis transformed a group of previously relatively obscure public health officials and politicians into a group of well-known leadership personalities-donald low, marcia taylor, doris greenspun, colin d'cunha, sheila basrur, tony clement, james young-who took care of democracy while it was dormant in the shadow of the "new normal". this "decisionism with a populist face" was an interesting development not in tune with the zeitgeist of moving from government to governance. it was, however, very much in line with the notion of "performativity", as sars and the crisis it brought to urban society, was "performed" by more or less media savvy actors, who were always only minutes ahead of the general public and the press as the epidemic progressed and ultimately subsided. at the other end of the spectrum of agents "performing" the sars crisis was the ill-fated and pompous appearance of toronto mayor mel lastman on cnn at the occasion of the who's travel advisory against toronto. lastman, ignorant of the context of global health governance in which "his" city found itself and apparently unfamiliar with the who, spouted out venom against the un organization which, in his eyes, unduly interfered with toronto's self-governance. these actors/agents were put on stage by the arrival of the virus and they played "crisis" and invented a new mode of governance as they went along. while they were by no means unprepared for the epidemic, public officials joined regular citizens in performing a disease that no one yet knew. through the ways citizens and experts in toronto (and singapore and hong kong and elsewhere) performed the disease, the world learned about sars. it seems that the "institutional void" hajer ( ) sees emerging in this context was filled, at least on an ad-hoc basis, by rapid policy change in an emergency situation created by the potentially catastrophic threat posed by sars. the ideological precepts of the "new normal" enabled the state to reassert itself as an active participant in public life after neoliberal reforms in ontario had stripped its involvement in many areas of public welfare to the bare minimum and to reinsert itself with some legitimacy in a policy community which had learned to not trust a government that had de-funded public institutions such as healthcare and education at an unprecedented scale (keil ) . this kept the ontario government "in the game" at a critical time-at least until such measures were challenged by the general public, healthcare workers' associations, patients and their relatives and the press. the loss of clear boundaries for jurisdictions is, of course, a direct outgrowth of global city formation and the growing incapacity of the (local) state in particular to deal with crises visited upon an urban region by its growing internationalization (friedmann [ (friedmann [ ] . the growing challenge presented by global city formation to the fiscal and institutional capacity of the local state is exacerbated by the processes invoked by hajer but also by the ongoing re-scaling of political spaces in a rapidly changing world. specifically with respect to global cities, it has been noted that conceptually and pragmatically the business of municipal politics as well as the conduct of everyday life has been both de-localized in profound ways through economic and cultural globalizations, and re-localized through the idiosyncracies of topologies, which bring together the myriad social connectivities in the microcosms of the world's urban centres (smith ) . urban health governance is embedded in a larger system of urban governance with its vertical and horizontal ties to other levels of government and into civil society and the private sector. urban governance in toronto had been characterized by the city's forced amalgamation in , which initially changed the landscape of public policy significantly towards a more competitive, coercive and stratified environment. this coincided with fundamental changes to municipal politics and internal governance processes as the city has been trying to establish a sense of harmonized "good government" and civic engagement after amalgamation. the outcome of these processes was contradictory: on the one hand hardcore neoliberal reforms were rolled out and downloaded by the tory provincial government between and and often followed through by a conservative and boosterist mayor mel lastman who was unapologetically the spokesperson of an aggressive business lobby and particularly the development industry; on the other hand, progressive politicians at the municipal level with the support of a continuously active social and environmental movement sector, the public sector unions and an electorate which had not forgiven the tories for their attack on toronto political traditions. the result of these contradictions was that urban governance in toronto at the time of the sars outbreak was split as continued reform in the municipal administration, and certain "forgotten" policy areas such as food, homelessness the environment-and public healthcompeted with neoliberal development mantra of a business elite which began to use the newly amalgamated city as their strategic terrain for interurban competition. inside the municipal administration, departmental restructuring and harmonization had led to insecurity, at least temporarily, as to the procedures and substance of urban policy when political cultures of suburban jurisdictions were melded with the downtown's more progressive, democratic traditions, which had led to more sustained rights claims of more diverse populations. this progressive city/conservative suburb split in the geography of toronto's urban governance was challenged by the new immigration and settlement patterns, which made suburbs more diverse than the inner city and the inner city potentially less dynamic politically than the multiculturally invigorated suburbs. during the time of the sars outbreak, this shift complicated matters significantly as the crisis was played out in geographic and social areas of the city-scarborough and north york-which remained largely terrae incognitae to the old toronto elite. the sars crisis intersected with business as usual in urban governance in as far as it was recast quickly from a health crisis to an economic crisis once the worst of the outbreak was over. the worry among toronto politicians and business people over lost business in tourism and entertainment fell in line with the usual propensity of urban officials and civic leaders to heave their city above its competitors in economic development, cultural creation and tourist attraction. in this sense, the sars crisis interfered with the strategic goals of the governing regime of toronto and the governing institutions that had created their success. the peculiar balance of social, economic, environmental and state interests in elite and popular circles that made up the governing coalition of the urban region was threatened by sars, which was contextualized in a series of setbacks for the region's economic progress and civic self-esteem, the loss of the bid for the olympic games to beijing in particular. the question was how these changes contextualized health governance in a time of crisis. the institute on governance defines health governance in canada as follows: in canada, the governance of healthcare is built on intergovernmental cooperation, reflecting a formal division of powers regarding healthcare as outlined in the canadian constitution and the charter of rights and freedoms. in addition, governance of healthcare also takes place outside the governmental sphere. this complexity requires organizations, sectors, regions, first nations communities and governments to forge capacities to govern (http://www.iog.ca/ knowledge areas.asp?pageid= , accessed november ). the institute proceeds to define the most pressing healthcare challenges in canada as follows: • critically assessing the alignment of health governance structures and processes with best practices. • reframing the understanding of governance as expanded beyond an individual institution to include mutual accountabilities among providers. • building ways for health providers to share information and work in a complementary way. • strengthening boards of directors, particularly in hospital governance. • building stronger relationships between voluntary sector organizations and government and between the various levels of government, including first nations (ibid). while clearly open to the complexity and multi-scalarity of health governance, this list of priorities is also characterized by a glaring absence of any reference to the role of cities in health governance. this absence is two-fold. there is, on one hand, the traditional obscurity that municipal politics suffers in the canadian state architecture (keil and young forthcoming); on the other hand, there is a more general eclipse at work here which disregards or even dismisses the role of urban governance in the management of societal matters in a post-westphalian world. we believe, though, that urban public health authorities and their associates in local hospitals, urban non-state actors in the health field as well as workers in urban medical settings have played an important role in the detection, identification, monitoring and fight against eids in particular (interviews july to december : toronto public health official, associate medical officer of health-toronto, university hospital network official, microbiologist-in-chief-toronto hospital, ontario nursing association official, public safety and emergency preparedness canada official). they have provided the core responsibilities of public health-assessment, policy development, assurance-often without support and sometimes in conflict with and in contradistinction to higher level health authorities (rodwin and gusmano : fn). one analysis revealed about the ontario situation during sars: the province of ontario was ill-prepared to deal with an infectious disease threat on such a scale. in canada, the provision of healthcare, including public health, is a provincial responsibility. however, the financial and operational responsibility for public health had increasingly been shifted to municipalities such that, at the time of the sars outbreak, funding was shared equally between the two levels of government. this funding shift created a decentralised public-health system, with the province's public-health units operating quite independently of each other (lim et al : , emphasis added) . sanford and ali ( ) have documented aspects of "new public health hegemony" in the response to sars in toronto. they specifically argue that there has been a mix of old and new measures at various scales that was pervasive and that overall a new hegemony around new epidemiological techniques, risk management, morality and security took shape. extending this work to the specific context of urban governance, a number of preliminary observations can now be made in order to characterize the urban health governance challenges identified in toronto during and after the sars outbreaks of . the urban health governance system experienced a very specific set of pressures, which spoke to the kinds of fundamental decisions that have to be made by urban-scaled and municipal authorities in a moment of epidemic disease. affonso, andrews and jeffs ( : - ) have perceptively identified three sets of paradoxes that led to three sets of dilemmas in the governance of the sars outbreak. these paradoxes/dilemmas were, first, that healthcare workers became sources of transmission and active sustainers of the sars case matrix (leading to the dilemma to be forced to decide whose safety gets priority: patients or caregivers?). second, hospitals were sources of sars infection in the community, breaking down the boundaries of medical care and community in threatening ways (leading to the question of how far do providers of healthcare have to go to provide safe spaces?). third, a culturally and ethnically diverse city may be particularly vulnerable to infectious diseases (prompting the question about the relationship of civil liberties and disease control). in terms of urban governance, these three couples of paradoxes and dilemmas denote spatio-institutional uncertainties of a new kind, which challenge traditional modes of integration and regulation of economic institutions (labour markets/work places), specialized functional spaces (hospitals), public institutions (public health agencies), codified private behaviours (patient versus citizen rights), etc. in an urban governance model, questions need to be directed at the particular ways through which state action (public health, security, etc), private sector involvement (providers of masks, medical equipment, drugs, etc.) and civic organizations (ethnic initiatives against racism, protection of workers' rights, etc) and individual civil rights claims (patients, quarantined individuals, travellers, etc) are coordinated by whom, at what scale and with what procedural democratic means. affonso, andrews and jeffs ( ) make a number of incisive and plausible recommendations as to how to improve health governance in future outbreaks of the kind endured in which centre around patient safety and workforce safety, spatial profiling and risk assessment, as well as community mobilization ( : - ) . it is important to note in the context of the question of urban governance before us that each of these intended measures would have a tangible impact on the day-to-day business of governing cities through democratic political rather than managerial-administrative processes at the municipal level. the core dilemmas these processes would face in the reality of current canadian municipalism is first the lack of autonomy local agencies have in the face of an unreformed federalism, which sees cities (and their institutions) as mere units of the administrative state (of the province and canada) and not as political decision-makers on their own terms; and second the tremendous weakening of lower state and governance structures-often despite rhetorical statements to the contrary on the effect of devolution and subsidiarity-in the face of the globalization and neoliberalization of the canadian state, including the increasing porosity towards supra-national institutions such as the who. we have some evidence on how the local state institutions in toronto themselves saw the crisis and what lessons they suggested to draw from it. the former provincial medical officer of health, colin d'cunha ( ) , detailed the various lessons learned from the outbreak, mostly through the lens of health reporting. the provincial scale is extremely important in the canadian system where municipalities are dependent on upper level policy frameworks and financing without much autonomy for local agencies and institutions. urban governance is severely constricted and clearly defined by this situation. while the municipal state may also be the most politicized of the three levels of government, it remains under the tight supervision of the province in particular and while state expenditures have risen consistently since the s in the federal and provincial governments, municipal funds have not kept pace with the demands placed on them through decades of downloading and devolution (villeneuve and séguin, ) . d'cunha, whose provincial agency was responsible for local health units in ontario, notes in particular that the reportable disease information system in place when sars hit, had been introduced in the s. a new system of reporting, the integrated public health information system (iphis), although available since early in the century, was only to be implemented in the spring of and was further delayed through sars. the provincial level system of surveillance was tied in with the global public health intelligence network (gphin). the provincial health protection and promotion act (hppa) makes mandatory disease reporting and control. it was amended after the sars crisis to empower the province to facilitate isolation of infected individuals (d'cunha ) . d'cunha's office was also left in dire straits in the wake of serious de-funding of public health institutions at the provincial level under a tory government after . the provincial health authority appeared very much like an empty shell which had coordinating functions of local authorities but could not muster the resources to do a good job giving direction and provide credible leadership to municipal and regional agencies (interview, associate medical officer of health-toronto, october ) . in the context of this legal and institutional framework, local-scale health agencies do their work. sheila basrur, the former municipal officer of health, and co-authors have noted that the main roles of toronto public health during the outbreak were case investigation and management, identification and quarantine of contacts, disease surveillance and reporting, health risk assessment and infection control advice to health institutions and other community settings (basrur et al : ) . the sars crisis posed a significant stress on the already severely compromised public health system of toronto as other public health services were cut or reduced to "essential services only" (ibid: - ). the kinds of measures under the responsibility of the municipal public health hegemony reflect the temporally layered and overlapping traditions stemming from the "bacteriological city", updated and redefined through more recent developments. the point to note in this respect is the often confusing unevenness in measures from various periods, phases, and moments of urban governance, which were haphazardly re-grouped into a recombinant mix of place-specific sets of trials and errors. while the coercive and enabling qualities of an existing municipal public health system were tested daily with unexpected twists in the proliferation of the disease, a new administrative reality emerged in the shadow of the successes and failures of an iterative policy process. cases of temporal unevenness were, for example, the deployment of quarantine and isolation orders for the first time in years (with no living administrative memory of and hence no experiential knowledge with such measures in the system) and the much younger (but failing) -year-old provincially authorized surveillance system (which had not kept pace with both technological advances and procedural necessities that had occurred since its inception) (basrur et al ) . the unevenness here related in both cases to the fact that two measures at two ends of a developmental scale in public health measures-the rather traditional and rather blunt tool of the quarantine, and the biopolitical, yet informationalized surveillancewere potentially at odds with the constituencies and clienteles they were meant to protect (and whose general rights sensibilities were a far cry from the mid-twentieth century) and, in the case of the failed surveillance, certainly not up to the challenge that the sars outbreak posed. one influential way to understand the local state is to see it as a sphere of influence of both the state and civil society (kirby ; magnusson ) . civil society is dramatically redefined in the context of the "new normal". in the immediate crisis in the spring of , it became rapidly clear that the "new normal" was not just a rewriting of a few hospital protocols and ministry directives. in true fashion of creating a new "governmentality" through new "technologies of power" in the foucauldian sense (osborne and rose ), the "new normal" became a new standard of societal interaction overall, accepted and even disseminated by the "normalized" everyday actions of urban residents, and the yardstick of urban governance. as we are writing this, toronto is going through emergency preparedness week, which calls on everyone to do their part in putting obstacles in the way of harm. the event organizers are clear that they expect citizens to do their part when taking in exhibits under "the theme 'what are your reasons for being prepared?' the city's exhibits will help toronto residents increase their awareness of emergency-preparedness issues and answer this question for themselves. residents will have the chance to speak with representatives from the city's co-ordinated emergency response teams, view emergency equipment, and pick up important personal emergency preparedness literature" (http://www.toronto.ca/wes/ techservices/oem/index.htm, accessed may ). while civic duty is part of the overall deal, awareness of the possible pitfalls of running a society on an emergency mindset are also part of the public debate. gro harlem brundtland's powerful statement that "with globalization, a single microbial sea washes all of human kind" (quoted in harris and seid b: ) stands as a starting point of our considerations here. like brundtland, who was the director general of the who during the sars crisis, "hundreds of thousands of men and women around the world devote their working lives and intellectual creativity to protecting our health" (markel : ) . that they do this in a wide variety of institutions-state and non-state; private sector and civil society basedand that they are crossing boundaries of disciplines and professional practice all the time, is an important insight: the crisis of the nation-statebased system does not lead to a simple replacement of the international by an elusive global system of health governance. instead, it is the conviction that undergirds this article that certain re-territorializations are key to the reworking of health governance globally. leading science journalist laurie garrett wrote in her prescient betrayal of public trust ( : ) that "[s]afety . . . is as much a local as international issue. in public health terms every city is a 'sister city' with every other metropolis on earth". particularly "metropolitanization" is of great consequence as urban areas have been in the centre of re-emerging diseases such as sars and tb. on the basis of evidence from the sars outbreak in toronto, canada, we have argued in this article that more attention needs to be paid to the changing relationships of urban governance and (re-)emerging infectious disease. towards that end, we specifically looked at two dimensions of urban governance during the sars crisis. first, the way the legacy of the "bacteriological city" was reinterpreted in the sars crisis; second, the way in which the local health governance was embedded in a "post-westphalian" order of health governance. through reading these two dimensions against one another, we have discussed how urban governance-under potentially lasting conditions of the "new normal"-must face the new (or reemerging) challenge of dealing with infectious disease and that global health governance may be better off by taking the possibilities that lie in metropolitan governance more seriously. the toronto case study has revealed a rich casebook of evidence on how state institutions at various scales from the global to the localin constant interaction with civil society and economic actors-have shaped a new modus operandi in how to deal with infectious disease threats in a globalizing environment. not only have cities played a major role as sites and conduits of disease, they have also picked up their share of participating in new forms of governance that brings the (local) state back in. having said that, however, we also showed that both concepts-city and state-are becoming perforated as the "institutional void" around emerging infectious disease corrodes firm boundaries between jurisdictional responsibilities of territorial states and city regions. while sars pricked the skin of the global city system and showed the relative permeability of the westphalian nationstate order by germs, it reconfirmed a certain rigidity of borders (both external and internal) for human mobility. as global health governance made airports biopolitical switching stations and public health officials reverted to quarantine and other measures of sequestration, the state reaffirmed its power in no uncertain terms. as in the early days of the bacteriological city, when municipal administrations created a physical and social infrastructure of hygiene in the struggle against epidemics, urban governance gets assigned new responsibilities ranging from flu preparedness to surveillance once again. but the city is not what it used to be. in an age of heightened urban unboundedness our image of cities is recast "as nodes that gather flow and juxtapose diversity, as places of overlapping-but not necessarily connected-relational networks, as perforated entities with connections that stretch far back in time and space and resulting from all of this, as spatial formations of continuously changing composition, character and reach" (amin : ) . the new politics of place that amin sees on the horizon in this new world of perforated urban spaces now also has to take into account the politics of infectious disease we have discussed in this article. endnotes sars is caused by a coronavirus, which is assumed to have moved through zoonotic infection from civet cats in southern china to rural and urban human populations there, and subsequently to urban populations in several large, globalizing cities around the world, with beijing, guangzhou, hong kong, singapore and toronto among the ones that were affected most. in the canadian metropolis toronto sars claimed lives in two consecutive outbreaks, as people were confirmed infected cases, and thousands were quarantined. the economic fallout of the outbreak was tremendous as entire economic sectors-tourism, film, etc-suffered huge losses from which they have just begun to recover two years later (abraham ; fidler ; mclean et al ) . we have discussed these connections in greater detail in where we have brought foucault's work to bear on an analysis of racialization of the sars outbreak in toronto; see also sarasin (forthcoming) on this subject. this dialectics is different from but related to the one that gandy refers to when he points out the "devastating disparities between the mobility of capital and labour that condemn much of humanity to economic serfdom" which exist in the shadow of the "connections, networks and flows" which some see as characteristic of our current society (gandy a: - ) . defined as "the capacity of local officials to perform the core functions of public health": assessment, policy development, assurance (rodwin and gusmano : fn) "'westphalian' refers to the governance framework that defined international public health activities from the mid-nineteenth century" based on the political logic of sovereign nation-states that had come into existence after the years war (fidler : - ) . we are grateful to one of the reviewers who correctly pointed out that concentrations of disease in pre-industrial port cities had already led to internationally agreed-upon practices of disease control such as quarantine. we have reviewed this history in ali and keil (forthcoming). in canada, the healthcare system has long been seen as a major area of neoliberalization. we have seen the privatization of healthcare delivery that has potentially damaging effects on the model of social solidarity which underlies that country's medicare system. at the demand end of the neoliberalization and privatization of healthcare, individuals are now more likely to be held responsible for their health and to pay for services needed to address health issues. there is a large critical literature on this in the public domain, of which these are good examples: "canada needs a public health care system" (canadian dimension august ) and gindin et al ( ) . http://www.health.gov.on.ca/english/providers/program/pubhealth/sars/docs/new normal/dir bg .pdf, accessed february ). such measures were, for example, publicized widely on the website of the university health network, http://www.uhn.ca/home/sars/. cdc director warns sars, monkeypox are the "new normal", reported on wane-tv, http://www.wane.com/global/story.asp?s= , accessed february . she also was paraphrased as saying that "world travel has become common" that "anti-terrorism efforts have helped public health officials prepare for the infectious disease threat" and called "sars a very sobering reminder of the global community people share". geberding made similar comments on cbs television's early show on june , http://www.cbsnews.com/stories/ / / / earlyshow/health/health news/main .shtml, accessed february . "performativity" is inspired by the definition of "performance/name of action" proposed by bruno latour ( : ) , meaning that an "actor does not yet have an essence. it is defined only as a list of effects-or performances-in a laboratory. only later does one deduce from these performances a competence, that is, a substance that explains why the actor behaves as it does". mayor lastman was interviewed on cnn by aaron brown on april and displayed stunning ignorance of the who, its purpose and powers (the globe and mail :a ). a similar chain of events occurred when the ontario government, after making much noise about privatizing electricity supply and provision, stepped into the blackout crisis of august . after having lost all credibility earlier that year in questions of electricity, the ensuing crisis mode allowed premier ernie eves to appear on newspaper front pages as a strong leader who gets things done and problems under control. this section is based on boudreau et al (forthcoming), keil ( ) , keil and boudreau ( ) , keil and young (forthcoming) , kipfer and keil ( ) . our research in toronto benefited greatly from interviews with the following experts: bannerji a, toronto, march ; booth c, toronto, january ; finkelstein m, toronto, october ; gardam m, toronto, november ; low d, toronto, november ; macdonald v, toronto, september ; young j, toronto, december . d'cunha was removed from the position he held during the crisis because many considered his performance during the crisis as incompetent and insufficient. he was replaced on february by sheila basrur. for a comparative chinese perspective, see hongyi ( ). it must be noted, however, that canadians on the whole are less civil liberties conscious than most americans. collective necessity and public security often trumps concerns over individual freedoms in canada. whether it was the war measures act during the october crisis of the s when tanks rolled in montreal or in current public opinion 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cooperation? a tale of smallpox in two cities health impacts of globalization: towards global governance european cities: social conflicts and governance collateral damage: the unforeseen effects of emergency outbreak policies the search for political space planning and public health: research options for an emerging field cities under siege: urban planning and the threat of infectious disease sars according to mel. the globe and mail sars: a case study in emerging infections diseases of globalization: socioeconomic transitions and health governing cities: notes on the spatialisation of virtue unhealthy landscapes: policy recommendations on land use change and infectious disease emergence too much fuss? hugh pennington on the sars virus the new public health: health and self in the age of risk. thousand oaks: sage pierre j ( ) comparative urban governance: uncovering complex causalities presentation at conference "invisible enemies the world cities project: rationale, organization, and design for comparison of megacity health systems powers of freedom: reframing political thought the new public health hegemony: response to severe acute respiratory syndrome (sars) in toronto re-placing the nation: an agenda for comparative urban politics public health and urban development: the plague in surat world city topologies looking back to look forward: reflections on urban regime analysis world city network: a global urban analysis power and decision-making in the city: political perspectives global health policy, local realities: the fallacy of the level playing field this research has been generously supported by a social sciences and humanities research council canada (sshrc) standard grant. we gratefully acknowledge the research assistance of claire major and sarah sanford. key: cord- -plwyjhl authors: fu, xinmiao; ying, qi; zeng, tieyong; long, tao; wang, yan title: simulating and forecasting the cumulative confirmed cases of sars-cov- in china by boltzmann function-based regression analyses date: - - journal: journal of infection doi: . /j.jinf. . . sha: doc_id: cord_uid: plwyjhl • cumulative confirmed cases in china were well fitted with boltzmann function. • potential total numbers of confirmed cases in different regions were estimated. • key dates indicating minimal daily number of new confirmed cases were estimated. • cumulative confirmed cases of sars-cov were well fitted to boltzmann function. • the boltzmann function was, for the first time, applied to epidemic analysis. in this journal, zhu et al. recently reported the results of their genomic analysis of multidrug-resistant klebsiella pneumoniae isolates from individual patients before and after colistin treatment highlighting the rapid emergence and multifaceted molecular mechanisms of colistin resistance in k. pneumoniae. this work highlights the therapeutic and public-health challenges of colistinresistance (cr), which is increasingly used as a large resort antibiotic, despite its unattractive toxicity profile and narrow therapeutic window. oral non-absorbed colistin has been proposed as a decontamination strategy in intensive care units and for patients carrying multidrug resistant enterobacterales (mdr-e). , the impact of decolonization strategies in terms of emergence of cr has rarely been monitored because no reliable selective medium existed and cr was not considered a public-health problem. recently, reliable universal culture media have been developed to screen for cr. here, we studied the impact of non-absorbed oral colistin on the emergence of cr in the gut microbiota of patients from the rgnosis-wp randomized controlled trial. thirty-nine subjects colonized with mdr-e were randomized to receive oral colistin sulfate miu times a day + neomycin sulfate mg bid for days followed by a fecal microbiota transplant (fmt) from healthy donors, or no intervention. stool samples were collected on visit v (screening sample), v (after days of oral decontamination and before fmt for the intervention group), v , v and v , respectively - days, - days and - days later. stool samples from donors and subjects from the intervention group and from the control group were available for this work and plated on drigalski plates (control) and superpolymyxin r plates. colony forming units (cfu) counts of all gram-negative rods were determined. isolates growing on superpolymyxin r plates were identified by maldi-tof; cr was confirmed by the culture-based rapid polymyxin np test and mic determined by the microdilution method. the limit of detection was cfu/g of stool. cr-e. coli were sequenced using the illumina hiseq technology. to determine whether cr isolates were present before the intervention, a specific mcr- pcr was performed on patients stool prior to intervention (v ) and on the donor's stool. electroporation of plasmids was performed to localize the gene conferring resistance to colistin and neomycin and molecular typing of the electroporants was performed using pcr based replicon typing (pbrt). ✩ université de paris, iame, inserm, umr- no patient or donor included in the trial carried cr isolates on v . among the patients in the intervention group two ( . %, [ic − ; ], p = . ) carried cr isolates at least at one visit after the intervention ( fig. ) . no cr-enterobacterales was detected in the stools of subjects from the control group. among both subjects with cr-enterobacterales, one carried log cfu/g of hafnia paralvei , a species which is intrinsically resistant to colistin (mic = mg/l), also resistant to neomycin (mic = mg/l) on visit and the other carried log cfu/g and log cfu/g cr-e. coli at visits and , respectively, with a colistin mic at mg/l. relative abundance of cr-e. coli increased between v and v from . % to % of the total enterobacterales population. the cr-e. coli recovered at v and v both belonged to phylogroup c st group and carried the serotype o :h . a plasmid-borne mcr- . gene encoding for cr as well as a aph( )-ia gene conferring resistance to neomycin were identified, both being co-located on the same inchi plasmid. in addition, resistance genes conferring resistance to hygromycin b ( aph( )-ia ), sulfonamides ( sul ), tetracyclines ( tet(a) ) and phenicols ( flor and cata ), all antibiotics used in veterinary medicine, were evidenced. for both subjects, cr strains could not be retrieved in the initial stool of the subject or in the donor's stool. pcr experiments performed with specific primers to detect mcr- gene directly on the pre-therapeutic stool were also negative. to our knowledge, this is the first report of the in-vivo selection of cr-enterobacterales in the gut microbiota of patients after oral decontamination by colistin. the selection of cr strains (a naturally-resistant h. paralvei and a mcr- producing e. coli ), both resistant to colistin and neomycin, may be the result either of the enrichment process by sod of preexisting cr strains that had not been initially detected because of very low abundances, or of an exogenous acquisition, either from other individuals or through fmt. indeed the transmission from fmt of mdr strains from positive donors is a potential risk. despite our efforts to decrease the limit of detection of mcr producers by using a pcr technique directly on the pre-therapeutic stool sample and the donors' stools, we failed to detect the parental strain, either because cr strains were in intestinal niches, the limit of detection remained too high, or the strain was acquired exogenously. however, the mcr- -positive e. coli is likely of animal origin according to its genetic features and its co-resistance profile. indeed, phylogroup st is frequently encountered among avian pathogenic e. coli (apec) and co-resistances to many antibiotics used specifically in veterinary medicine is striking. furthermore, the aph( )-ia gene confers resistance to neomycin and paromomycin, the latter commonly used in cattle and pigs. the selection of the mcr- producer is an illustration of the "one health" problem of resistance: a strain likely to have been selected by veterinary antibiotics among animals ended up in a patient's gut, later enriched by the use of colistin and neomycin as decontaminant. although the small number of subjects is a clear limitation, this observation is a "proof-of-concept" of the risk of selection of cr-enterobacterales after oral colistin treatment and fmt, at a time when colistin is one of the last resort antibiotics to treat mdr-enterobacterales infections. the selection of commensal cr-e. coli is especially worrying, given the pathogenic potential of e. coli and its ability to widely colonize animals and humans. given the controversial results of oral decontamination by colistin, we believe it should only be used with precautions and with thorough monitoring of cr. we read with interest a recent paper in this journal by luzatti and colleagues, who explored the significance of the presence of herpes simplex virus (hsv) dna in lower respiratory tract (lrt) specimens for the diagnosis of hsv pneumonia in immunocompromised patients. the authors underlined the difficulty in gauging the clinical relevance of such a laboratory finding in the absence of histopathological data, as hsv shedding in the lrt may occur in the absence of disease. the interpretation of real-time pcr results for diagnosis of pneumocystis jirovecii (pj) pneumonia (pjp) faces an analogous challenge, since the presence of pj dna in lrt may reflect colonization (carriage) rather than infection. there is limited information on the clinical value of pj real-time pcr in diagnosing pjp in patients with hematological diseases; - this is exceedingly challenging as the sensitivity of direct examination procedures is suboptimal due to low fungal burdens. here, we report on our experience on this matter. a total of episodes of pneumonia occurring in consecutive patients with hematological disorders in which pjp was considered in the differential etiological diagnosis were included. of these, episodes developed in patients undergoing either allogeneic hematopoietic stem cell transplantation-allo-hsct-( n = ) or autologous-hsct ( n = ), and in non-transplant patients (acute leukemia, n = ; lymphoma, n = ; chronic leukemia, n = ; others, n = ). the patients were attended at the hospital clínico universitario-hcu-( n = ) or at the hospital universitario politécnico "la fe" -hlf-( n = ) between june and august . no patients in the cohort tested positive for hiv. this study was approved by the respective hospital ethics committee and informed consent was obtained from all patients. a single specimen per episode was available for diagnosis (bal fluids, n = ; sputa, n = ; ta, n = and bronchial biopsy, n = ). the realcycler pjir kit r (progenie molecular, spain) was used at hcu, and the pneumocystis jirovecii real time pcr detection (certest biotech; zaragoza, spain) was employed at hlf (see footnote in table ). both assays target the large sub-unit of ribosomal (mtlsu) rna gene. preliminary experiments using bal specimens indicated that both assays yield comparable pcr cycle thresholds (c t s) (median, . , range, . - . vs. median . ; range, . - . , respectively; p = . ). all specimens tested negative by direct examination for pj, whereas were positive by real-time pcr (bal, n = ; sputa, n = , and ta, n = ); following stringent clinical, microbiological and imaging criteria ( table ) , pjp was deemed to be the most probable diagnosis in episodes occurring in unique patients. no histopathological confirmation of pjp was available for any patient. pcr c t values inversely correlate with fungal burden in the sample. which is higher in patients with pjp than in colonized individuals. here, overall, pj pcr c t s in specimens from patients with pjp tended to be lower than in pj carriers ( p = . ); when only bal fluid specimens were considered, the difference reached statistical significance (median, . ; range, . - . vs. median . ; range, . - . ; p = . ). this finding is likely related to use of more standardized procedures for bal fluid sampling. receiver operating characteristic (roc) curve analysis showed that a threshold c t value of . in bal specimens displayed a sensitivity of . % ( % ci, . - %) and a specificity of % ( % ci, . - %) for pjp diagnosis. a number of studies have established different c t s cut-offs for that purpose, [ ] [ ] [ ] [ ] . in our view, however, the variability in the performance of different pcr assays and sampling conditions, heterogeneity of patient populations, and in particular the lack of a pj international standard material for pcr result normalization precludes defining a consensus universal threshold nowadays. the absence of anti-pj prophylaxis, treatment with corticosteroids and serum ldh levels ≥ u/l have been shown to be associated with pjp. here, patients not undergoing anti-pj prophylaxis were more likely to display a clinically significant pj pcr result ( table ). in turn, roc curve analysis indicated that a cut-off ldh value ≥ u/l had a sensitivity of . % (ci %, . - %) and specificity of % ( % ci, . - . %) for pjp diagnosis. in univariate regression logistic models, serum ldh values ≥ u/l were associated with a clinically significant positive pcr pj result (or, . ; % ci, . - . ; p = . ). in contrast, corticosteroid use within the month before sampling was not different between the probability of pneumocystis jirovecii (pj) pneumonia (pjp) for each patient was retrospectively evaluated by an expert committee including infectious diseases and microbiology specialists at both centers, on the basis of (i) documented pj presence in respiratory specimens by microscopy; (ii) compatibility of clinical signs and symptoms (at least of the following: subtle onset of progressive dyspnea, pyrexia, nonproductive cough, hypoxaemia and chest pain), (iii) compatible (suggestive) radiological findings (chest radiograph and/or high-resolution computed tomographic scan detection of interstitial opacities and/or diffuse infiltration infiltrates); (iv) complete resolution of symptoms after a full course of anti-pjp treatment; (v) absence of alternative diagnosis. the efficacy of therapy was assessed on a daily basis. pjp was ruled out if real-time pcr for pj tested negative, or if clinical recovery occurred in the absence of pj-targeted antimicrobial therapy. pj colonization (carriage) was the most likely possibility when patients did not meet the above criteria and an alternate diagnosis was made. b frequencies were compared using the χ test (fisher exact test) for categorical variables. two-sided exact p values were reported and p values ≤ . were considered statistically significant. the data were analyzed with the spss (version . ) statistical package. c respiratory tract specimens were obtained following conventional procedures. specimens were examined for presence of ascus or trophic forms of pj by microscopy following blue toluidine, calcofluor white or grocott's methenamine silver staining. cytospin preparations were prepared from bal specimens for direct examination. sputa and ta samples were mixed v/v with sputasol (oxoid, uk) and vortexed for min. all samples were centrifuged at g for min, and the pellets were resuspended / in . % nacl for further processing. for real-time pcr, dna was extracted from μl of specimens using the qiaamp dna blood mini kit (qiagen, hilden, germany) on either qia symphony or ez- platforms (qiagen), following the manufacturer's instructions. at hcu, a commercially-available real-time pcr assay previously evaluated by others, the realcycler pjir kit r (progenie molecular, spain), which targets the mitochondrial large sub-unit of ribosomal (mtlsu) rna gene, was used according to the manufacturer's instructions ( http://www.progenie-molecular.com/pjir-u-in.pdf ). at hlf, the commercially-available pneumocystis jirovecii real time pcr detection. (certest biotech; zaragoza, spain), which also targets the large sub-unit of ribosomal (mtlsu) rna gene, was employed following the manufacturer instructions ( https://www.certest. es/wpontent/uploads/ / /viasure _ real _ time _ pcr _ pneumocystis _ jirovecii _ sp .pdf ). at both centers pcr were performed in the applied biosystems fast real-time pcr platform (applied biosystems, ca, usa). pcr results were reported as positive or negative. for positive samples, threshold cycle (c t ) values were also recorded. no standard curve was generated with a positive control for quantitative estimations. d antimicrobial prophylaxis for pjp was performed with trimethoprim-sulfamethoxazole (tmp/smx), one double-strength tablet ( mg tmp/ mg smx) given (in allogeneic hsct patients) or times a week with oral folic acid ( , ) . patients with suspicion of pjp according to the attending physician were treated with tmp/smx - mg/kg (tmp) - mg/kg (smx) per day for - weeks. e in all these cases, death was attributable to pjp. patients with clinically significant pj detection and pj carriers ( table ) . detection or recovery of other microbial agents (one or more) was documented in of the specimens testing positive by pj pcr ( table ). in line with a previous report, this microbiological finding was significantly less frequent ( p = . ) in specimens from patients with pjp than in colonized patients; in fact, microbial co-detection was inversely associated with pjp in univariate logistic regression models (or, . ; % ci, . - . ; p = . ). strengths of the current study are the following: (i) clinical categorization of pjp was based upon stringent criteria defined by a multidisciplinary team; (ii) only hematological patients were included; (iii) a comprehensive routine investigation of microbial causes of pneumonia other than pj was conducted; (iv) the experience of two centers was collected. in addition to its retrospective nature, our study also has some limitations: (i) we cannot completely rule out that some patients categorized as being pj carriers did in fact have pjp, as most of these patients received full courses of tmp/smx in combination with antimicrobials targeting other microbial agents. the lack of standardized criteria for pjp diagnosis makes clinical misclassification of patients a potential drawback in studies such as ours, particularly when no positive microscopy or histopathology findings are available; (ii) although we evaluated bal, bronchoalveolar lavage; pjp, pneumocysis jirovecii pneumonia; ta, tracheal aspirate. a as per our routine protocol, all specimens were examined by gram and acid-fast bacilli stain. samples were also examined for presence of respiratory viruses (rvs) using either the luminex xtag rvp fast assay (luminex molecular diagnostics, austin, tx,usa) at hcu, or the clart® pneumovir assay (genomica, coslada, spain) at both centers, as previously reported. semiquantitative (sputa) and quantitative (bal and ta) cultures for bacteria were performed on conventional media: bacterial loads > cfu/ml or > cfu/ml were deemed to be clinically relevant on bal fluids and ta samples, respectively. specimens were cultured on bcye-alpha agar, bd (becton dickinson) mgit® ( mycobacteria growth indicator tube)/lowenstein-jensen agar slants and sabouraud agar for recovery of legionella pneumophila, mycobacterium spp., and other fungal organisms, respectively. the platelia tm aspergillus ag kit (bio-rad, hercules, ca, usa) was used for quantitation of aspergillus spp. galactomannan in bal fluid and serum specimens. all bal fluid specimens underwent cytomegalovirus (cmv) pcr testing using the realtime cmv pcr assay (abbott molecular) at hcu or the cmv r-gene® assay (biomerieux) at hlf, as previously reported. over patients, only presumptively had pjp; (iii) two different commercially-available pcr assays were used across centers. nevertheless, we found them to yield rather comparable c t s. in summary, we found that a positive pj pcr result in respiratory specimens from transplant and non-transplant hematological patients with pneumonia frequently reflects colonization rather than infection; pcr c t values in bal fluids, serum ldh levels and lack of co-detection of other microorganisms potentially involved may be helpful in clinical categorization in the absence of positive by pj microcopy results. we have no conflict of interest to declare. dear editor , poller et al., in this journal, provided a useful consensus for use of personal protective equipment for managing high consequence infectious disease . although this was driven largely by recent ebola virus disease emergencies, we should remind your readers of the continuing problem of lassa fever (lf) in west africa. lf is a febrile infectious disease caused by lassa virus. the clinical presentation of the disease is nonspecific and includes fever, fatigue, hemorrhage, gastrointestinal symptoms, respiratory symptoms, and neurological symptoms . the observed case fatality rate among patients hospitalized with severe lf is - % , . the disease is mainly spread to humans through contamination with the urine or faeces of infected rats . human-to-human transmission can occur through contact with the body fluids of infected per-sons. therefore, health care workers are at high risk for infection when the standard precautions for infection prevention and control including appropriate personal protective equipment are inadequate . it is estimated that there are approximately , lf cases annually, resulting in approximately deaths in west african countries . in , nigeria had a large lf outbreak, and we previously reported epidemiological characteristics of the outbreak, analyzing data collected between january and may . however, information on laboratory-negative suspected cases was not enough to conduct a case-control study to fully determine the risk factors and clinical characteristics of the disease. nigeria had a lf outbreak in as well. here we report the epidemiological and clinical characteristics of the outbreak including case-control analysis against laboratory-negative suspected cases using data collected between st january and th october . from january to december , there were suspected cases, including laboratory-confirmed lf cases. in , there were suspected cases reported by th october, including laboratory-confirmed lf cases. details on the case definition, laboratory test, surveillance, and data collection have been described previously. of the confirmed lf cases, there were fatalities (case fatality rate, . %) in and fatalities (case fatality rate, . %) in . the number of laboratory-confirmed lf cases and positivity rate peaked in the dry season (january-march) in both and ( fig. (a) ). the largest number of laboratory-confirmed lf cases were reported from the neighboring edo and ondo states in both and ( fig. (b) ). there were laboratory-confirmed lf cases in states such as kebbi and zamfara that had no reported cases previously, in . during the study period, the detailed demographic and clinical information was collected for laboratory-confirmed lf cases (of cases, . %) and laboratory-negative suspected cases (of cases, . %). chi-square tests were conducted to compare the distribution of age, sex, and each symptom between the laboratory-confirmed lf cases and laboratory-negative suspected cases ( table ). the proportion of children was significantly lower in laboratory-confirmed lf cases compared with that in laboratory-negative suspected cases. the proportion of males was significantly higher in laboratory-confirmed lf cases than that in laboratory-negative suspected cases. fever was the most prevalent symptom in both laboratoryconfirmed lf cases and laboratory-negative suspected cases, followed by headache ( table ) . gastrointestinal symptoms, such as abdominal pain, vomiting, and diarrhea, were observed in more than % of laboratory-confirmed lf cases, whereas hemorrhaging was observed in . % of laboratory-confirmed lf cases. while the prevalence of face/neck edema was low even in laboratoryconfirmed lf cases ( . %), nonetheless, the odds ratio of having face/neck edema was . times high for laboratory-confirmed lf cases. we here reported the lf outbreak in - largest recorded in history. while previous studies have focused on laboratory-confirmed lf cases and mainly compared fatal cases and survived cases, , , our observation revealed the difference between laboratory-confirmed lf cases and laboratory-negative suspected cases. the age and sex distribution differed significantly between laboratory-confirmed lf cases and laboratory-negative suspected cases. fever, headache, and gastrointestinal symptoms were the most common symptoms in laboratory-confirmed lf cases, which are similar to those reported previously. , however, these symptoms were also prevalent in laboratory-negative suspected cases. clinical guidelines for lf state that edema in the face and neck is a specific sign of the disease. the present study found that the symptom had a significantly high odds ratio for confirmed lf although the prevalence of this symptom was low. unfortunately, we did not determine the differential diagnosis for the laboratory-negative suspected cases. laboratory tests for the differential diagnoses are now underway for the lf-negative samples collected during the outbreak. the results would provide us further insight for better clinical management of patients with febrile illnesses in lf-endemic areas. in addition to the standard precautions for infection prevention and control including appropriate personal protective equipment pointed out by poller et al., it is important to know epidemiological and clinical characteristics of high consequence infectious diseases such as lf. that would help healthcare workers and public health officers increase an index of suspicion of the diseases, further leading to better clinical management and surveillance. the authors have declared that no conflicts of interest exist. this work was partially supported by the leading initiative for excellent young researchers from the ministry of education , culture, sport, science & technology of japan and the japan society for the promotion of science (grant number, ). the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. these authors contributed equally to this article. accepted december available online january https://doi.org/ . /j.jinf. . . © the british infection association. published by elsevier ltd. all rights reserved. recently, several studies in this journal have demonstrated the threat of animal-derived viruses to humans. [ ] [ ] [ ] since , an increase in human pseudorabies virus (prv) infection cases has been reported in china, indicating a new animal-derived virus threat to human health. porcine pseudorabies (pr), also known as aujeszky's disease, is one of the most economically important viral diseases in pigs globally. its causative agent is prv, which is classified into the genus varicellovirus of subfamily alphaherpesvirinae , family herpesviridae . prv is almost always fatal in newborn piglets, is frequently accompanied by neurological symptoms, and may cause abortions and/or stillbirths in pregnant sows. prv primarily infects members of the suidae family and can also infect other domestic and wild mammals, including horses, cattle, sheep, goats, dogs, cats, etc. currently, vaccination is the most effective strategy for pr prevention and control in pigs worldwide. in china, prv infections in pigs were first recorded in . in the s, an inactivated vaccine consisting of the bartha-k vaccine strain was imported into china. since then, this vaccine has been widely used in pig vaccination for pr prevention and control. before , no large pr outbreaks were reported in pigs in china. however, after late , novel prv wild-type variants emerged in nearly all regions of china and affected a number of swine herds vaccinated regularly with the bartha-k vaccine, resulting in significant economic losses. subsequent animal experiments indicated that the bartha-k vaccine could not provide complete protection for pigs against a challenge with novel prv wild-type variants in china. for control and eradication of pr, the disease was listed in the "mid-and long-term animal disease prevention and control program in china ( - )" by the chinese government, with the aim of eliminating pr in china by ( http://www.gov.cn/zwgk/ - / /content _ .htm ). however, vaccination for prv is still voluntary and not required in china. a nationwide epidemiological investigation in demonstrated a high prevalence of . % of prv among swine herds in china. humans were previously regarded as refractory for prv infection, although serological prv antibody positivity was found in three cases. in , the first human prv infection case with direct molecular evidence was reported in china (case , table ). in this case, the eyes of a -year-old woman were directly exposed to sewage on a hog farm. in the following two weeks, symptoms of fever, headache, coma, and endophthalmitis were observed in the patient. next-generation sequencing (ngs) indicated that prv dna was detected in her vitreous humor samples but not in her cerebrospinal fluid (csf). after surgery, the patient was discharged, but her vision remained impaired. in a subsequent study, zhao et al. table clinical characteristics and other information on the twelve human prv infection cases in china. analyzed csf samples from four patients with encephalitis of unknown etiology using ngs (cases - , table ) and found molecular evidence of prv infection. in addition, retinitis and blindness was observed in two cases (cases , , table ), and the patient in case died. the occupation of the four patients was all associated with pork production/sale/cooking. in , six other human prv infection cases involving encephalitis were reported in china, and all patients were pork/pig handlers or veterinarians. [ ] [ ] [ ] it was noted that all patients still suffered from various sequelae after discharge, except for in one case where the patient died. increasing reports on human prv infection cases in china have recently indicated that prv poses a significant threat to public health in china, especially in people in close contact with sick pigs and/or related pork products/contaminants. to reduce the risk of prv infection in susceptible workers, it is necessary to promulgate relevant policies by the chinese government to promote pr vaccine development to protect pigs from infection with novel prv wild-type variants currently circulating in china. in addition, relevant policies should be updated by the chinese government to monitor vaccination status and virus variation in pigs nationwide. moreover, it seems that prv can infect humans via injury to the skin or eyes. until now, no effective drugs to prevent the progression of the disease caused by prv infection have been reported. therefore, it is necessary to improve biosafety and self-protection awareness in susceptible populations that have contact with sick pigs and work in jobs related to handling pork products/contaminants. promoting drug development for curing prv-related disease in infected patients may also help reduce the currently increasing threat of prv to human health in china. all authors declare that they have no competing interests. dear editor, the emergence and spread of gram-negative bacteria, for example, klebsiella pneumoniae , co-producing carbapenemases and mobilized colistin resistance ( mcr ) genes limit our choice for treating multidrug-resistant infections, posing significant threats to public health. herein, we reported the discovery of mcr- gene in k. pneumoniae strains isolated from patients in eight european countries, including belgium ( n = ), denmark ( n = ), montenegro ( n = ), poland ( n = ), romania ( n = ), serbia ( n = ), slovenia ( n = ), and spain ( n = ). notably, the co-existence of mcr- and the carbapenemase-encoding genes, ndm- , vim- , and oxa- were confirmed in k. pneumoniae isolates of human origin. phylogenetic analysis suggested that mcr- -carrying k. pneumoniae isolates, including carbapenem-resistant and five susceptible k. pneumoniae strains, show a highly geographically clustered pattern. genetic environment analysis revealed the presence of insertion element is , is or a cupin fold metalloprotein, wbuc, in the mcr- flanking. taken together, these findings indicated that mcr- has existed for a long time and already spread among crkp isolates of human origin in europe since , further increasing the significant threat of public health through either the nosocomial spread or environmental routes. the mobilized colistin resistance ( mcr ) gene mcr- was detected in human gut microbiomes, which has been disseminating across three continents, including asia, europe and america, recently published in the journal of infection. the rapid increase in carbapenem resistance among gram-negative bacteria worldwide has greatly compromised the efficacy of carbapenem antibiotics, which has gotten renewed attention to the importance of polymyxin antibiotics for multidrug-resistant (mdr) infections. recently, sophia david and colleagues reported the epidemic of carbapenem-resistant klebsiella pneumoniae (crkp) in europe, which raised concern that mobile carbapenemase resistance determinants were widely spread in european hospital settings, and inter-hospital spread is far more frequent within, rather than between, countries. however, limited information regarding the co-occurrence of carbapenemases and mcr genes in the klebsiella pneumoniae ( k. pneumoniae ) isolates have been provided. plasmid-mediated resistance genes mcr as well as tet (x /x ) have been widespread in bacterial species of animal, human, and environment origin as well as human and animal gut microbiomes worldwide, where is a huge arg reservoir with a high horizontal gene transfer possibility. , - several studies - illustrated that the newly described mcr- has spread beyond the united states into europe and asia, and into other enterobacteriaceae species. of clinical concern is the inevitable spread of a plasmid harboring the mcr- gene into a crkp isolate, which has been listed by the world health organization as a critical priority antibiotic-resistant bacterial pathogen for which new antibiotics are urgently needed. in response to this potential clinical problem, we download > k. pneumoniae genomes isolated from hospitals in european countries and the , complete bacterial genome sequence (accessed july ), and explored the distribution of plasmid-mediated resistance genes mcr and tet (x /x ). we are surprised to find that the complete mcr- gene (nucleotide = %) was present in k. pneumoniae isolates of k. pneumoniae strains from belgium ( n = ), denmark ( n = ), montenegro ( n = ), poland ( n = ), romania ( n = ), serbia ( n = ), slovenia ( n = ), and spain ( n = ) (table s ). additionally, of the k. pneumoniae isolates of human origin were crkp strains and only five were carbapenem-susceptive isolates (table s ). as reported, these mcr- -harbouring strains were isolated from patients in europe between and . these results suggest that mcr- gene might have been presented in europe for a long time and already spread to the crkp isolates, which is a major cause of both hospital-and community-acquired infections. to further analyze these mcr- -positive k. pneumoniae isolates, the resistome of the draft genome was analyzed using the comprehensive antibiotic resistance database. interestingly, the mcr- gene was co-existed with various carbapenemase-encoding genes: in eleven isolates with ndm- , eight with vim- , and two with oxa- ( fig. (a) ). it should be noted that the mcr- -and ndm- -carrying isolates were distributed in denmark ( n = ), montenegro ( n = ), romania ( n = ), and serbia ( n = ), as well as several other beta-lactam resistance determinants (for example, tem- , cmy- , oxa- and shv- ) ( fig. (a) and table s ). moreover, the mcr- -and vim- -harbouring isolates were dominant in spain ( n = ) and slovenia ( n = ), as well as two beta-lactamase-encoding genes (non-carbapenemases) (ctx-m- and shv- ) ( fig. (a) and table s ). it is worrying that a crkp isolate from spain in was carrying mcr- , vim- , and oxa- genes simultaneously. the presence of mcr- in crkp isolates from patients is of critical importance as mcr- could be present in hospital-borne outbreaks cre strains in the future. from whole-genome shotgun (wgs) data of the mcr- -positive k. pneumoniae isolates, sequences types (sts) were extracted and assigned to nine different types, i.e. , , , , , , , , , and ( fig. (a) ). phylogenetic analysis suggested that mcr- -carrying k. pneumoniae isolates show a highly geographical clustering pattern ( fig. (a) ). isolates from patients in the same hospital were clustered into one clade, for example, in spain and montenegro. overall, the k. pneumoniae isolates from different countries were genetically diverse, suggesting that the mcr- -positive k. pneumoniae isolates were also genetically diverse and that mcr- could disseminate among different k. pneumoniae isolates, mainly by nosocomial transmission. nowadays, all known mcr genes have been detected in various gram-negative bacterial species, whereas a small number of studies have shown the presence of mcr- , mcr- , mcr- , and mcr- in k. pneumoniae isolates from animal and human origin at relatively low detection rate. - the presence of mcr- in the crkp isolates indicated that this novel mcr gene may already be widely spread among k. pneumoniae isolates of human origin in europe. we subsequently searched mcr- gene in , complete bacterial genome sequence and ncbi-nr database ( october ) in the ncbi, to fully understand the prevalence of mcr- gene in klebsiella species isolates. interestingly, the mcr- gene (identity > % and % query coverage) was present in various bacterial genomes, including three klebsiella species isolates consisting of k. pneumoniae ( n = ), k. quasipneumoniae ( n = ), and k. oxytoca ( n = ) (table s ) . therefore, further studies focusing on the epidemiology and transmission mechanism of mcr genes, in particular mcr- in klebsiella species of human origin are warranted to better understand the public health threat of emergence of antibiotic resistance among clinical k. pneumoniae . contigs carrying mcr- in k. pneumoniae isolates could be classified into two groups (for example, gca_ . and gca_ . ) (table s ) . genetic environments analysis indicated that the presence of insertion element is and wbuc (a cupin fold metalloprotein), in the mcr- (gca_ . , ∼ kb) upstream and downstream flanking, respectively, similar to (identity > %) the plasmid sequences of pme- a, pctxm _ , and pmrvim , and contigs from of e. coli isolate a and nz_naan from salmonella ( fig. (b) ). additionally, mcr- in another contig ∼ . kb was in the upstream of two insertion element is and is , as well as a beta-lactamase-encoding resistance gene ctx-m- , which similar to the plasmid sequence of pmrvim . we did not detect the downstream regulatory genes (qsec and qseb) found in the isolates that harbor mcr- . , moreover, we were unable to determine whether a complete is element is upstream due to a short mcr- -bearing contig that is available for comparison ( fig. (b) ). therefore, a long-read sequencing coupled with a hybrid assembly method is needed to fully evaluate and monitor the transfer and development of args, especially mcr- among crkp isolates. although two unique plasmid-mediated tigecycline resistance genes firstly discovered in bacteria of animal origin in china and subsequently identified in many bacterial isolates of human, animal and environment origin, including klebsiella species, as well as human and animal gut microbiomes, , , none of them was detected in the k. pneumoniae strains in europe. in summary, we reported the discovery of mcr- gene in clinical k. pneumoniae strains of human origin in eight european countries. importantly, the mcr- gene was co-existed with different carbapenemase-encoding genes in the same strains. the spread of mcr- , ndm- , vim- , and oxa- and other beta-lactam resistance determinants (non-carbapenemase) carrying by crkp appears likely to be by plasmid dissemination, as the genes identified in isolates belonging to a diverse set of sts distributed in different hospitals in europe. it is noteworthy that all these mcr- -positive crkp strains were isolated between and , highlighting an earlier presence of mcr- among crkp around the world than previously known. these findings raise the likelihood of ongoing undetected mcr- gene spread among cre strains. therefore, further study is urgently needed to understand the prevalence and dissemination of mcr- , especially in cre and crkp strains, and effective measures should be taken to control its spread. g.f.g. designed the study. y.n.w. and f.l. collected and downloaded the datasets. y.n.w., f.l., y.f.h., b.l.z., g.p.z., and g.f.g. analyzed and interpreted the data. y.n.w. and g.f.g. wrote the draft of the manuscript. all authors discussed, reviewed and approved the final report. supplementary information is available for this paper. correspondence and requests for materials should be addressed to g.f.g. the authors declare no competing interests. the interesting systematic review by amin-chowdhury and colleagues provides information about outbreaks of severe pneumococcal disease (spd) in closed settings that occurred in the conjugate vaccines era . it shows that vaccine-type spd outbreaks are still occurring and it highlights the lack of consensus on how to manage such outbreaks. in the following, we will describe how we managed a recent outbreak of spd in norway. in march , møre and romsdal hospital trust notified the norwegian institute of public health (niph) about a cluster of spd amongst men working in shipyards in møre and romsdal county. serotype data from niph were available for nine of the cases -all were serotype . the majority of cases had been working at one specific shipyard. municipal medical officers (mmo), the norwegian labour inspection authority (nlia), and niph formed a multidisciplinary outbreak team to investigate and control the outbreak. we formed specific case definitions: each case had to have resided in møre and romsdal county in the period from . january onwards and: confirmed : had invasive pneumococcal disease (ipd) with serotype isolated from a normally sterile site. probable : worked at the specific shipyard and had a clinical presentation compatible with lower respiratory tract infection or ipd, but without microbiological confirmation or serotype isolated from a non-sterile medium (e.g. nasopharyngeal swab or sputum culture). we identified cases, ten confirmed and ten probable in the period between . january and . april ( fig. ). all available isolates were serotype ( confirmed, probable) and were susceptible to penicillin. fifteen isolates were sequence type (st) , while two were a single locus variant of , st , . all cases were men between and years, with a mean age of years. fifteen were hospitalized. four were norwegian citizens, the remaining came from other european countries. seven cases smoked. one case had an underlying medical risk condition. immunization history against pneumococci were unknown for all. the cases had several professions; mostly related to interior outfitting and metal welding. approximately individuals worked at the shipyard in the time period. many of them lived in temporary accommodation. at an on-site inspection of the shipyard, nlia observed a polluted atmospheric work environment and little use of personal protective equipment. several measures were put in place to control the outbreak, including information and advice to raise symptom awareness and to reinforce hand and respiratory hygiene, vaccination and occupational corrections. local medical clinics and hospital were alerted about the outbreak and advised to have a low threshold to admit and treat suspected cases. mmo held information meetings with shift leaders, and written information about spd in several languages was distributed to workers to increase spd awareness. intensified hygiene measures were implemented at the ship yard and housing quarters. nlia ordered immediate occupational corrections related to controlling the atmospheric work environment. niph recommended vaccination with the -valent conjugate vaccine (pcv ) to interrupt transmission and prevent disease. both the pcv and the -valent polysaccharide vaccine provide protection against serotype , but pcv was preferred as this may also affect colonization. as several work tasks were conducted in parallel process in confined spaces with suboptimal ventilation, we were unable to identify a single target group for vaccination. hence, the shipyard offered vaccination to all workers. occupational health service promptly vaccinated all workers during a four-day period. contrary to the majority of studies included in the systematic review, niph did not recommend chemoprophylaxis. as the workers were otherwise healthy (i.e. no high risk group like old age, immunocompromising conditions etc.), and since it was impossible to target a specific group of workers, niph deemed it undesirable to distribute antibiotics to asymptomatic workers, with the possibility of inducing antimicrobial resistance and possible side effects. due to high turnover of personnel it was not possible to calculate an attack rate. we did not find any new cases after control measures were implemented. no deaths have been reported in relation to the outbreak. this outbreak closely resembles one of the outbreaks described in the systematic review; between april and june , an outbreak with serotype , st occurred at a shipyard in belfast . we are also aware of an outbreak this fall, , at a shipyard in finland with serotype (st ), and f . although welders are a known risk group for spd, in all these three outbreaks, people who worked closely alongside welders were also infected. in addition to exposure to welding fumes, the crammed and poorly ventilated working conditions, and possibly housing conditions, may have increased the risk of developing spd and facilitated the transmission of pneumococci in this closed setting. overall, this norwegian outbreak extends the knowledge about how to manage and control outbreaks of spd in closed settings. none. in this journal brunet and colleagues discussed reactivation of latent infections in the context of chronic disease, solid organ transplantation or long-term immunosuppressive treatment. we recently observed the reactivation of leishmania infection in a -year-old patient receiving methotrexate for psoriasis, who was diagnosed with visceral leishmaniasis (vl) showing a mucocutaneous involvement. we analyzed the epidemiologic and clinical characteristics of all cases of leishmaniasis in patients with psoriasis found through a review of the literature. our patient was admitted into the infectious disease unit of paolo giaccone hospital, in palermo, with a painless and ulcerated lesion onto the oral mucosa ( fig. a ) , two nodular ulcerated lesions on the right knee and another one on instep of the right foot appeared one month before ( fig. b ) . the patient did not travel outside italy during the last year. he had been suffering from lowgrade fever in the last month. considering the above findings leishmaniasis was suspected and a needle aspiration of oral and cutaneous lesions was arranged in order to perform microscopy and leishmania-pcr, which were positive for leishmania. laboratory tests exhibited: wbc /mmc, hb . g/dl, c reactive protein, . mg/l; positive serology for leishmania (igg / ) and positive leishmania-pcr test on peripheral blood. abdominal us examination revealed splenomegaly ( cm); methotrexate was suspended and liposomal amphotericin b, mg/kg per day for days, followed by two further administrations two weeks later was started. cutaneous and mucosal lesions improved at the end of the first days of therapy and completely vanished after two further administrations, days from the beginning of treatment. leishmania-pcr on peripheral blood after days of therapy was negative. table shows the literature data about characteristics, therapy and outcome of patients with psoriasis and leishmaniasis. leishmaniasis is a vector-born chronic infectious disease caused by protozoa of the genus leishmania and transmitted to humans by the bite of phlebotomine sandflies. in europe, the mediterranean countries are the most affected areas. leishmania parasite establishes chronic intracellular parasitism, survives for an infected person's lifetime and, in the event of major immune deficiency, may be reactivated from sites of latency. leishmaniasis can present with a spectrum of clinical manifestations and three patterns of infection are described: cutaneous (cl), mucosal or mucocutaneous (ml or mcl) and visceral leishmaniasis (vl). the infecting species of leishmania is very important in determining the clinical manifestations and the host immune response is crucial in determining the clinical outcome of infection . today, non-hiv related immunosuppressive conditions are becoming increasingly prevalent, mainly because of better medical care of patients with chronic illnesses and the therapeutic use of immunosuppressive drugs. in the field of rheumatology, leishmaniasis has been reported in association with the use of various immunosuppressive drugs. the introduction of tumor necrosis factor-alpha (tnf-α) antagonist drugs has received much attention recently and several cases of vl have been reported in rheumatic patients who do anti-tnf α drugs. psoriasis is a chronic inflammatory autoimmune disease affecting - % of the world's population and characterized by an aberrant hyper-proliferation of keratinocytes. the pathogenesis of psoriasis is complex. genetic susceptibility, environmental triggering factors and an over-reaction of local innate immune response initiate inflammation. subsequent involvement of adaptive immune response with production of th cytokines, chemokines and growth factors lead to epidermal hyperplasia. recently, a functional role of interleukin- -producing t helper cells (th ) in psoriasis has been suggested by their reduction during successful anti-tnf treatment. it is also known that th lymphocytes play an essential role in protecting against intracellular protozoa and in the successful clearance of leishmania by strengthening the th response. in view of this, it could be argued that psoriasis may represent a protective factor for leishmania infection. indeed, in our review we did not found any case of leishmaniasis in psoriatic subjects who were not under immunosuppressive therapies. biological agents, which are powerful immunosuppressive drugs, have been more and more used in rheumatic patients and leishmania infections have been reported among anti-tnf-agents users. recently maritati et al. found higher prevalence of subclinical leishmaniasis in patients with inflammatory rheumatic diseases receiving biological drugs than those treated with other immunosuppressive drugs. however, leishmaniasis has also been reported in psoriatic patients not receiving biological drugs, as occurred to our patient ( table ) . diagnosis of cl in psoriatic patients is challenging, as it mimics many other infections or a flare-up of psoriasis itself that can lead to ineffective and harmful changes of therapy. immunosuppressive therapies cause atypical manifestations of leishmaniasis with large lesions spread over large cutaneous areas and associated to a possible mucosal involvement. ml by l. infantum is very rare and only sporadically described in patients receiving powerful immunosuppressive therapies or in hiv-coinfected patients. mcl is mostly observed in latin america where l. braziliensis accounts for most cases, but l. panamensis, l. guyanensis, and l. amazonensis have also been implicated. only rarely cutaneous lesions extend to areas of skin distant from the mucosa involved, as in our case in which two lesions on the foot and knee were associated with the oral lesion. in the context of impaired immunity, it is also advisable to rule out vl by pcr-leismania on peripheral blood so as to establish the most appropriate therapy: intralesional or intravenous. finally, there is no agreement on appropriate screening for leishmaniasis before immunosuppressive treatments and on the strategy to be followed after the diagnosis of leishmaniasis in rheumatic patients taking immunosuppressive drugs. molecular methods are highly sensitive and specific tools for the diagnosis of visceral leishmaniasis and a screening with leishmania-pcr in immunosuppressed patients living in endemic areas could be useful to identify patients at highest risk of reactivation. specific leishmaniasis treatment followed by suspension of the immunosuppressive therapy was adopted by most of the authors. overall even if the treatment response is not as good as seen in the immunocompetent population, our review reports a good outcome in all cases and patients remained relapse-free without maintenance therapy and despite the ongoing use of immunosuppressive medication. in conclusion physicians must be alert to the possibility of development of leishmaniasis in immunosuppressed rheumatic patients. adequate screening for vl should be incorporated into the list of baseline studies to carry out before initiating biologic therapies, at least in endemic areas. the authors declare that there is no conflict of interest. as demonstrated in several studies in journal of infection , herpesviruses pose an increasing threat to human health. [ ] [ ] [ ] according to international committee on taxonomy of viruses (ictv), equine herpesviruses (ehvs) belong to the family herpesviridae . until now, a total of ehv species types have been determined in equines, viz. ehv -ehv . among them, ehv and ehv are the most relevant herpesviruses affecting equines. both ehv and ehv infection are associated with upper respiratory tract disease, but only ehv infection could cause abortion and myeloencephalitis. ehv and ehv are prevalent in equines on all continents and have considerable economic impact on the horse industry. in china, the number of equines is very large, reaching to be ∼ . million in ( http://www.stats.gov.cn/tjsj/zxfb/ ). ehv infection in equines was first reported in china in , and the epidemiological investigation since then indicated ehv was prevalent in the equine population in all the studied provinces in mainland china, with a seroprevalence ranging % − %. [ ] [ ] [ ] vaccination is commonly used to prevent and control ehv. however, china has not developed a commercially available ehv vaccine so far. ehv vaccine has a limited market application potential in china currently. due to the lack of relevant knowledge on ehv, most of the chinese horse owners always erroneously identified it as other common pathogen of equine respiratory diseases, and didn't realize its potential threat to equine health and reproduction. although the number of equines in china is large, most of them are labor/farming horses. to the best of our knowledge, even for racehorses, vaccination with ehv vaccine has not been performed in mainland china. considering the wide distribution and high prevalence of ehv in china, it is urgently to popularize knowledge on ehv in horse owners and promote market application prospects of ehv vaccine. in china, few veterinary researchers are currently investigating equine virus, including ehv. this is mainly caused by the change of equines' historical role. in the last century, a great number of equines were used for military in china. however, there is only one military equine farm in mainland china at present. considering a more important economic role of other domestic animals (e.g., pigs, chickens, and cattle) compared with equines, investigating equine virus (including ehv) is not a priority in the related guide policies issued by the chinese government. though epidemiological studies on ehv in china are limited, it still could be concluded that epidemic status of ehv is very complicated in china, which increases the difficulty in ehv vaccine development. in most provinces, ehv and ehv were co-circulating in equines with a high seroprevalence. until now, a total of ehv strains have been isolated from tissue samples of aborted equine fetuses ( from farming horses in northeast china in , from asian wild horses in western china in , from farming horses in western china in ). , in addition, a novel ehv strain was isolated from one horse with serious respiratory disease in northern china in . recently, our laboratory firstly determined the molecule evinces for ehv and ehv in racehorses in sothern china (data not shown). however, a more large-scale and surveillance of ehv in equines is necessary to fully understand epidemic status of ehv in china, which could establish a foundation for updating the composition of ehv vaccine developed in china in future. in other countries, much effort has been made to develop ehv vaccine, and modified-live and inactivated virus vaccines have been registered for sale. before an ehv vaccine is developed successfully in china by itself, it is necessary to vaccinate the susceptible equine population with an ehv vaccine commercially available from other countries to prevent and control ehv in china. however, a well-designed case-control animal challenge study still needs to estimate the protective efficacy of different vaccines against the field prevalent ehv strains in china. all authors declare that they have no competing interests. a recent review article on the treatment of hepatitis c with directly-acting antiviral (daa) drugs, makes numerous recommendations for baseline drug resistance testing. in our local practice, we have been performing baseline drug resistance testing for some years now, prior to the publication of these guidelines. we present a recent retrospective hcv kinetics analysis of these patients' changing viral loads in response to daa therapy below. such studies have been used previously to compare viral suppressive responses in different hcv genotypes and treatment regimens. , the patients were a mixture of treatment-naive and treatment-experienced (including with interferon-based, ns protease inhibitor-based and daa-based regimens) cases. the current standard of care for hepatitis (hcv) patients is a combination of direct acting antivirals (daas), for which there are three different hcv viral protein targets (ns , ns a and ns b). table ns , ns a, ns b resistance associated substitutions (ras), by hcv genotype, found in this patient cohort at baseline drug resistance testing (viral sequencing performed at imperial college, london, uk). the patients included a mixture of treatment-naïve and treatment experienced (i.e. interferon-based, ns protease inhibitor-based and more recent daa-based regimens) cases. resistance associated substitution (ras) by hcv genotype treatment with daas cure the vast majority of hcv-infected patients, with oral regimens having > % efficacy in most patient groups. , , treatment failure currently affects approximately % of treated patients and is often associated with the selection of resistance associated substitutions (ras). we performed hcv drug resistance testing both retrospectively (following treatment failures) and prospectively (prior to treatment) in our cohort of hcv genotype (g) - -infected patients, during march -june . viral extraction, pcr and sequencing were performed at imperial college, using qiagen viral rna mini kits (qiagen pn: , qiagen ltd., manchester, uk), and inhouse pcr and sanger sequencing methods on an abi prism -avant genetic analyser (thermo fischer scientific, loughborough, uk). the prediction of hcv genotype and drug sensitivities is derived from the geno pheno algorithm [ www.geno pheno.org ]. treatment regimens used during this period complied with contemporaneous nhs rate cards: for non-cirrhotic or compensated cirrhotic patients: g -treatment-naive: omb/par/rit + das + r; g -treatment-experienced: elb/grz + /-r; g -treatmentnaive/experienced: gle/pib; g -treatment-naive/experienced: gle/ pib; g -decompensated cirrhotic patients sof/led + r; g /g decompensated cirrhotic patients: sof/vel + r. we assessed the impact of any ras across g -g on hcv rna kinetics by analysing viral load (realtime hcv viral load, abbott m , abbott molecular uk, maidenhead, england) decline rates. we applied linear mixed regression to model the viral loads and assumed a linear decline (log scale) over time, using sas statistical software (sas institute inc., nc, usa). in this cohort of patients (n: g = , g = , g = ), hcv ras were found as shown in table . hcv rna viral load decline rates were found to be similar and not statistically different ( p = . ) at: − log and − . log per month, respectively, for g and g /g ( fig. ). this suggests that these viral load decline rates were similar across g -g infections despite baseline differences in viral load, ras profile, or a history of any previous treatment (i.e. interferon-based, older ns protease inhibitor-based, or more recent daa regimens). these results demonstrate similar hcv rna clearance efficacies of the various daa treatment regimens for g -g , in this patient cohort. although other studies on hcv kinetics have been published, they do not usually compare multiple hcv genotypes. similar studies on patients infected with g - viruses, and/or undergoing other daa treatment or retreatment combinations, , will be with great interest we have read the report of zhang et al. concerning the increased susceptibility to pertussis in chinese adults at childbearing age, as determined in a comparative seroprevalence study using samples collected from to . the authors describe that about % of the individuals had pt-igg antibodies, which is indicative of a recent infection. in the adults - years of age, . % subjects had undetectable pt-igg antibodies in but . % in / . it is well known that adolescents and adults have become the reservoir of pertussis and an important source of transmission to vulnerable infants. bordetella pertussis is commonly associated with atypical pneumonia as determined in hospitalized children. several seroprevalence studies conducted in different regions of china indicate that the incidence of pertussis is most likely underestimated. , this may be due to the use of insensitive diagnostics. at present, the diagnosis of pertussis in china is mainly based on culture. however, both the cdc and the world health organization (who) use pcr as the gold standard for diagnosis, in addition to culture. oropharyngeal or nasopharyngeal swabs were obtained from , inpatients aged between days and years of age with clinical suspicion of pertussis, enrolled from march to february in shenzhen children's hospital. more than % of all patients were younger than months of age. the hospitalized patients included , males and females (sex ratio, . ). all patients recovered after the treatment. a real time pcr assay targeting ptxa-pr was used to detect b. pertussis . of the , samples, ( . %) tested positive for b. pertussis by rt-pcr. our results indicate that despite vaccination pertussis remains a major health problem in china, since the prevalence of infection by b. pertussis in hospitalized children was high. the majority of patients were admitted because of pneumonia. the detection rate in hospitalized patients was lower than the rates reported earlier in shanghai and ji'nan. , this may be due to lower number of samples collected in these studies and due to the use of serology or culture methods. the overall prevalence rates were . % and . %, respectively. however, b. pertussis infection in female patients was significantly higher than in male patients (x = . , p < . ). this has earlier been reported by the ecdc and haberling et al. and may point to a genetic association with susceptibility to b. pertussis . the detection rates were dependent on age in patients (x = . , p < . ). the prevalence decreased with age: . % newborns, . % in infants, . % in toddlers, . % in (pre-) schoolers ( fig. ) . the high vulnerability of newborns and young infants for b. pertussis infection may be related to a combination of insufficient herd immunity and suboptimal protection against b. pertussis infection in children too young to be fully vaccinated. since vaccination rates in infants are already at %, it will be difficult to improve this further. therefore, other measures must be considered, including booster vaccination at pre-school age and vaccination during pregnancy. because young infants are mainly cared for by mothers and other adults, the most important cause of infection with b. pertussis is their close contact with parents and siblings. in general, b. pertussis was detected more often during seasonal changes, especially from late summer to early autumn. in hospitalized children the number of b. pertussis infections increased in march and september as compared to other months ( fig. ) . the seasonal infection rates were . % in spring, . % in summer, . % in autumn and . % in winter, respectively. the prevalence in the winter season was lower but not statistically different than in other seasons (x = . , p = . ). in this study, we used real-time pcr, the most accurate method to detect b. pertussis . the detection rate may be significantly lower than the actual level, because oropharyngeal samples in most patients were collected instead of nasopharyngeal samples, and the pcr target gene was ptxa-pr instead of is . is is present in high-copy numbers in b. pertussis whereas ptxa-pr is a single-copy target. however, the ptxa-pr pcr is more specific and will not detect b. parapertussis , which contributes to more than % of pertussis cases. many studies have shown that adolescents and adults with b. pertussis infections, causing chronic cough, are an important reservoir for transmission, putting newborns at high risk. maternal pertussis immunization prevents infant pertussis, as recently shown by amirthalingam et al. vaccine effectiveness against infant deaths was estimated at %, and disease incidence in infants < months of age has remained low. according to our results, vaccination of pregnant women and adults, especially those in close contact with infants and young children, may help to prevent pertussis in infants and young children in china. the authors have declared that no competing interests exist. this study was supported by the sanming project of medicine in shenzhen ( szsm ) and by the shenzhen science and technology project ( jcyj ). tang and colleagues reported in this journal their experience with covid- disease , the outbreak of which began in december in wuhan, hubei province, china , with spread to additional countries - as of the st february . here we report the clinical features and outcome of the first two cases of disease caused by sars-cov- infection in the united kingdom (uk) -the first imported and the second associated with probable person-toperson transmission within the uk. public health management will be reported separately. the index case (a) entered the uk on / / from hubei province in china. initially asymptomatic, this individual, a year-old female with no past medical history and on no regular medications, developed symptoms of fever and malaise on / / , accompanied by sore throat and dry cough. she had travelled with her partner and reported no infectious contacts prior to travel. on / / , a close household contact of the index case, a resident of the uk, developed symptoms of fever ( . °c), followed the next day by diffuse myalgia and a dry cough. this patient (case b) is a previously fit and well year-old male. he had returned to the uk from hubei province on / / . case b promptly sought advice via the national health service (nhs) self-referral service nhs , and he and case a were assessed as being possibly at risk of covid- , and were admitted to the regional infectious diseases unit at castle hill hospital, hull university teaching hospitals for isolation, assessment and diagnostic sampling. they were managed in separate negative pressure cubicles with anterooms. nursing and medical staff donned personal protective equipment (ppe) as recommended by public health england (phe). the clinical observations of each of the patients, together with their initial blood tests, are shown in table . ( fig. ) . clinical examination findings were unremarkable. initial investigations revealed only mild lymphopenia and elevation of crp, with mild neutrophilia in case b. periodic fever of - . °c was observed in case b until d of admission. repeat blood tests in this individual on d demonstrated mild acute kidney injury (aki, serum creatinine μmol/l). the aki was thought most likely due to dehydration, and resolved within h with administration of intravenous infusion of crystalloid at ml/h. cxr was normal. empirical oral antibiotic therapy (co-amoxyclav / mg p.o. t.d.s.) was administered on d , to cover the possibility of secondary bacterial infection, but was subsequently discontinued. symptoms resolved in case a by d and in case b by d of admission. pcr testing of sars-cov- from nose and throat swabs taken daily was negative from d onwards in case a and from d in case b (throat swabs from this individual were negative throughout). there was no clinical indication for the use of experimental antiviral therapies. patients were deisolated according to current phe guidance, based on complete resolution of symptoms and two sequential negative respiratory pcr tests at least h apart. rooms were decontaminated with . % hypochlorite followed by uv light treatment. the contact of these individuals remained asymptomatic throughout the days incubation period but was isolated as a precaution and to be close to family these first cases of sars-cov- are informative for clinicians caring for suspected and confirmed cases in the uk and elsewhere. reassuringly, illness in both individuals was relatively mild and short-lived, with no evidence of parenchymal lung disease (reflected by normal oxygenation and the absence of radiological infiltrates) or of the late-stage deterioration that has been reported in case series , possibly due to the absence of comorbidities. experimental antiviral therapeutic options for severe disease were not considered necessary given the mild clinical nature of the illness. clinical illness correlated with the presence of viral rna in upper airway samples ( fig. ) , with no evidence of prolonged asymptomatic shedding, although discordance between nose and throat samples in case b highlights the need to sample both areas. it was reasonably assumed that the source of infection in case b was close contact with symptomatic case a, given that the time from travel to china to onset of symptoms in case b was days, although this cannot be proven. based on this assumption, the period from exposure to disease onset appeared short, at approximately h, consistent with recent reports of the incubation period of sars-cov- . co-occurrence of respiratory viral infection, as we observed in case b with rhinovirus, has been described in the context of sars-cov- ( https://www.medrxiv.org/ content/ . / . . . v ) as it has with many other respiratory viruses spread by similar routes, and may have contributed to the increased symptomatology in case b. interestingly the partner of case a, who was a close household contact, remained asymptomatic throughout and had negative tests for sars-cov- shedding. it will be of interest to investigate the serological responses in this individual to ascertain evidence of subclinical infection. isolation, minimisation of contacts and use of appropriate ppe is a cornerstone of management of high consequence respiratory viral infection. in the cases reported here, phe recommendations for ppe were followed and there were no breeches in ppe or nosocomial transmission. this should provide reassurance to healthcare workers managing patients with suspected covid- in the uk that current ppe is both feasible and effective. the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. dear editor , as reported in this journal and elsewhere, an outbreak of atypical pneumonia caused by the zoonotic novel coronavirus (sars-cov- ) is on-going in china and has spread to the world. as of feb , ( : , gmt + ), there have been , confirmed patients and more than deaths from sars-cov- infection in china, and , confirmed patients and deaths in the most affected province, hubei province. much research progress has been made in dissecting the evolution and origin of sars-cov- and characterizing its clinical features. [ ] [ ] [ ] [ ] [ ] while the outbreak is on-going, people raise grave concerns about the future trajectory of the outbreak, especially given that the working and schooling time has been already dramatically postponed after the chinese lunar new year holiday was over (scheduled on jan ). in particular, a precise estimation of the potential total number of infected cases and/or confirmed cases is highly demanding. earlier studies based on susceptible-exposed-infectious-recovered metapopulation and susceptible-infected-recovered-dead models revealed the number of potentially infected cases and the basic reproductive number of sars-cov- . , , these traditional epidemiological models apparently require much detailed data for analysis. , here we explored a simple data-driven, boltzmann functionbased approach for estimation only based on the daily cumulative number of confirmed cases of sars-cov- (note: the rational for boltzmann function-based regression analysis is presented in supporting information (si) file). we decided to collect data (initially from jan to feb , ) in several typical regions of china, including the center of the outbreak (i.e. wuhan city and hubei province), other four most affected provinces (i.e., guangdong, zhejiang, henan, hunan) and top- major cities in china (i.e., beijing, shanghai, guangzhou, shenzhen). during data analysis on feb , , the number of new confirmed cases on feb in hubei province and wuhan city suddenly increased by , and , , respectively, of which , and , are those confirmed by clinical features (note: all the number of confirmed cases released by feb were counted according to the result of viral nucleic acid detection rather than by referring to clinical features). we thus arbitrarily distributed these suddenly added cases to the reported cumulative number of confirmed cases from jan to feb for hubei province by a fixed factor (refer to table s ), assuming that they were linearly accumulative in those days. it is the same forth with the data for wuhan city. regression analyses indicate that all sets of data were well fitted with the boltzmann function (all r values being close to . ; figs. a, b, s , and table ). the potential total number of confirmed cases for mainland china, hubei province, wuhan city, and other provinces were estimated as , ± , , ± , , ± and , ± ; respectively; those for provinces guangdong, zhejiang, henan and hunan were ± , ± , ± , ± , ± and ± , respectively ( table ) ; those for beijing, shanghai, guangzhou and shenzhen were ± , ± , ± and ± , respectively. in addition, we estimated the key date, on which the number of daily new confirmed cases is lower than . % of the potential total number as defined by us subjectively (refer to table ). the above analyses were performed assuming that the released data on the confirmed cases are precise. however, there is a health commission, the state administration of traditional chinese medicine, the academy of chinese medical sciences, provinces and cities, as well as the army ( fig. ) . huoshenshan hospital is a specialized hospital established in the wuhan staff sanatorium. patients with confirmed coronavirus pneumonia have been admitted to our hospital. it has a total of beds, and includes an intensive care unit, an ordinary care unit, a laboratory, and radiology and other auxiliary departments. according to the national health commission of the people's republic of china, the related design scheme of the institute was completed on january , . construction of the hospital began on january th, and the hospital was completed and put into use on february nd. the chinese people's liberation army has transferred medical personnel to undertake the task of helping people infected with the virus. we firmly believe that chinese medical personnel and people throughout the country can work together to win this defensive battle with one heart and one mind. herpes simplex virus (hsv) pneumonia in the non-ventilated 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indebted to all colleagues who contributed to this substudy in paris and geneva. in particular, we would like to thank no public or private funds were used for the current study. eliseo albert holds a río hortega research contract from the carlos iii health institute (ref. cm / ). estela giménez holds a juan rodés research contract from the carlos iii health institute (ref. jr / ). we thank all the staff of the domestic and international organizations who fought against this outbreak, including those at the various health care facilities, lassa fever diagnostic laborato-ries, nigeria centre for disease control, world health organization, african field epidemiology network, public health england, ehealth africa, pro health international, university of maryland baltimore, us centers for disease control and prevention, alliance for international medical action, médecins sans frontières, and numerous other partners. we also express our sincerest condolences to the families and friends of those who died during the outbreak. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sector. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . this work was supported by the national natural science foundation of china ( ), and the guangdong provincial natural science foundation ( a ). we are grateful to the patients for providing their written informed consent to publish this report. our thanks go to nursing, laboratory and medical colleagues in hull university teaching hospitals nhs trust and the newcastle upon tyne hospitals nhs foundation trust who contributed directly and indirectly to patient care, and to many colleagues in public health england and across the hcid network who contributed their time and expertise to the management of these cases. cjad is supported by a clinical research career development fellowship from the wellcome trust ( /z/ /z ). we thank graduate students (boyan lv, zhongyan li, zhongyu chen, yu cheng, mengmeng bian, shuang zhang, zuqin zhang, and wei yao; all from prof. xinmiao fu's research group at fujian normal university) for data collection. this work is support by the national natural science foundation of china (no. and to xf). the reported cumulative number of confirmed cases may have uncertainty. assuming the relative uncertainty follows a single-sided normal distribution with a mean of . and a standard deviation of %, the potential total number and key dates were estimated at % ci. for detail, refer to the methods section and figs. c, d, s and s .b key date is determined when the number of daily new confirmed cases is less than . % of the potential total number. tendency to miss-report some positive cases such that the reported numbers represent a lower limit. one typical example indicating this uncertainty is the sudden increase of more than new confirmed cases in hubei province on feb after clinical features were officially accepted as a standard for infection confirmation.another uncertainty might result from insufficient kits for viral nucleic acid detection at the early stage of the outbreak. we thus examined the effects of such uncertainty using a monte carlo method (for detail, refer to the methods section in si file). for simplicity, we assumed that the relative uncertainty of the reported data follows a single-sided normal distribution with a mean of . and a standard deviation of %. under the above conditions, the potential total numbers of confirmed cases of sars-cov- for different regions were estimated ( figs. c, d, s and s ) and summarized in table , ), respectively, indicating that overall the outbreak may not be so bad as previously estimated. such uncertainty analysis also allowed us to estimate the key dates at % ci. as summarized in table , the key dates for mainland china, hubei province, wuhan city, and other provinces would fall in ( / , / ), ( / , / ), ( / , / ) and ( / , / ), respectively.finally, the ongoing sars-cov- outbreak has undoubtedly caused us the memories of the sars-cov outbreak in . we thus collected the data from the who officiate website for analysis, and found that the cumulative numbers of confirmed cases of sars-cov both in china and worldwide were fitted well with the boltzmann function, with r being . and . , respectively ( figs. e and f) .in summary, we found that all data sets, including both the on-going outbreak of sars-cov- in china and the sars-cov epidemic in china and worldwide, were well fitted to the boltzmann function ( fig. and s ). these results strongly suggest that the boltzmann function is suitable for analyzing the epidemics of coronaviruses like sars-cov and sars-cov- . one advantage of this model is that it only needs the cumulative number of confirmed cases, somehow as simple as the recently proposed model. in addition, the estimated potential total numbers of confirmed cases and key dates may provide valuable guidance for chinese central and local governments to deal with this emerging threat at current critical stage. none. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . we appreciate the work tang et al. have report emergence of a novel coronavirus in china. the -ncov broke out in wuhan, china at the end of , and has attracted worldwide attention. [ ] [ ] [ ] although the chinese government has taken active measures to control this epidemic, the virus is very infectious. according to the real-time data of the national health commission of the people's republic of china up until february , , within a short period of half a month, the number of confirmed cases and the number of deaths were , and , respectively. the epidemic is progressing rapidly. -ncov poses new public health challenges in china. in wuhan, china, the number of local medical staff is insufficient for the demand resulting from the explosive increase in the number of infected patients. therefore, many medical personnel are needed to devote themselves to the front line of combating the virus.medical personnel throughout the country are led under the unified leadership of the chinese government. although the epidemic in wuhan is serious, a large number of medical staff rushed to wuhan to supplement the shortage of manpower in wuhan hospitals. this is a battle without smoke, the heroes of which are our medical staff. according to the national health commission of the people's republic of china, as of january , , hubei province opened , isolated patient beds, and about , healthcare professionals from all kinds of medical institutions are working on the front lines and providing care for patients with fevers, and for suspected or confirmed patients. in this time of emergency, under the unified deployment of the chinese government, there are medical teams including medical personnel from the national key: cord- -ghmqd yv authors: wang, peng-wei; ko, nai-ying; chang, yu-ping; wu, chia-fen; lu, wei-hsin; yen, cheng-fang title: subjective deterioration of physical and psychological health during the covid- pandemic in taiwan: their association with the adoption of protective behaviors and mental health problems date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: ghmqd yv this study aimed to determine the proportion of individuals who reported the deterioration of physical and psychological health during the coronavirus disease (covid- ) pandemic in taiwan. moreover, the related factors of deterioration of physical and psychological health and the association between deterioration of health and adoption of protective behavior against covid- and mental health problems were also examined. we recruited participants via a facebook advertisement. we determined the subjective physical and psychological health states, cognitive and affective construct of health belief, perceived social support, mental health problems, adoption of protective behavior and demographic characteristics among respondents ( women and men; mean age: . years with standard deviation . years). in total, . % and . % of respondents reported deteriorated physical and psychological health during the covid- pandemic, respectively. participants with higher perceived harm from covid- compared with severe acute respiratory syndrome (sars) were more likely to report the subjective deterioration of physical and psychological health, whereas respondents who were older and perceived a higher level of social support were less likely to report a deterioration of physical and psychological health. the subjective deterioration of psychological health was significantly associated with avoiding crowded places and wearing a mask. both subjective deteriorations of physical and psychological health positively related to general anxiety. the coronavirus disease (covid- ) pandemic has been raging globally. as a novel respiratory infectious disease that is highly contagious, the covid- pandemic has impacted int. j. environ. res. public health , , of physical [ ] and mental health [ , ] , the economy [ ] , education [ ] , quality of life [ ] , occupations [ ] , and the interpersonal relationships [ ] of humans. the first covid- case in taiwan was confirmed on january [ ] . due to proactive containment and comprehensive contact tracing, the number of covid- cases in taiwan has remained lower than in other countries [ ] . by august , taiwan had tested , individuals. a total of confirmed cases were identified, of which were domestic and had died [ ] . therefore, taiwan did not impose a social lockdown. however, the pandemic has impacted the economy and unemployment rate profoundly [ ] . in - , taiwan experienced a major outbreak of severe acute respiratory syndrome (sars). the covid- outbreak rekindled memories of sars and caused fear among the people of taiwan. covid- is a threat to the physical health of both infected individuals and the general public. a study in canada found that % of the population was very or extremely concerned about the impact of covid- to their health [ ] . an online-based study on the general public in china found that % of the participants experienced physical pain or discomfort on the euroqol- d evaluating health-related quality of life [ ] . the psychological health of the public has also been deeply affected by the covid- pandemic. a review study found that both specific populations such as children, elderly, and medical personnel and the general population were harmed psychologically by imposition of strict isolation during the covid- pandemic [ ] . the covid- pandemic might also threaten individual bodily integrity and autonomy and subsequently result in psychiatric comorbidity representing as atypical pictures, such as functional movement disorders [ ] . these studies examined the cross-sectional status of physical and psychological health among people during the covid- pandemic. given that covid- has impacted human lives rapidly and unprecedentedly, examining the deterioration of physical and psychological health since the pandemic began may provide insights into changes in health status during the covid- pandemic. several individual and environmental factors may correlate with the physical and psychological health problems evident during the covid- pandemic, such as pre-existing physical and mental health conditions [ , , [ ] [ ] [ ] , low income [ , ] , and experiencing the profound influence of the pandemic on daily activities [ , , ] . determining the modifiable factors predicting the deterioration of physical and psychological health during the covid- pandemic may provide evidence to develop prevention and intervention programs for the public affected by the covid- pandemic. the health belief model (hbm) can serve as a theoretical basis for determining the predictors of deteriorating physical and psychological health during the covid- pandemic. the hbm proposes cognitive and affective constructs that predict whether an individual will adopt health-promoting behaviors. these include perceived susceptibility to and severity of a health problem, perceived benefits of and barriers to engaging in recommended action, and the belief in one's ability to successfully perform a behavior [ , ] . several studies have examined the association of cognitive and affective constructs of health beliefs with physical and psychological health during the covid- pandemic. for example, perceived high vulnerability for contracting covid- [ , ] , perceived low survival likelihood [ ] , anxiety regarding contracting covid- [ ] , and the distress caused by the uncertainty of the endpoint of the covid- pandemic [ ] predict physical and psychological health during the covid- pandemic. however, hbm-based assessment is inadequate. liao et al. [ ] proposed cognitive and affective constructs of health beliefs concerning the risk of contracting ( ) influenza a/h n in and ( ) respiratory infectious diseases in future epidemics or pandemics. these can be used to examine the cognitive and affective constructs of health beliefs predicting physical and psychological health during the covid- pandemic. studies have found that levels of social support were significantly associated with self-efficacy and sleep quality and negatively associated with the degree of anxiety and stress among medical staff in china who were treating patients with covid- [ ] . however, the association between perceived social support and deteriorating physical health has not been well examined. studies on the association between demographic characteristics and physical and psychological health during the covid- pandemic have revealed mixed results. one study found that aging individuals had a higher risk of physical pain or discomfort and depression or anxiety [ ] , whereas other studies have found that young people were more likely to report mental health problems during the covid- pandemic [ , , ] . moreover, several studies have confirmed that women are more likely to report poor mental health during the covid- pandemic than men are [ , , , ] ; however, gender difference in determining physical health during the covid- pandemic has not been examined. further study is needed to examine whether demographic factors relate to the deterioration of physical and psychological health during the covid- pandemic. adopting protective behaviors, such as avoiding crowded places, washing hands frequently, and wearing a mask, are essential to prevent contracting covid- and staying healthy. a two-wave study in china indicated that precautionary measures, such as maintaining hand hygiene and wearing a mask, were associated with a lower psychological impact from the outbreak and lower levels of stress, anxiety, and depression in both the initial stage of the covid- outbreak [ ] and four weeks later [ ] . however, studies on people during the sars epidemic have reported that respondents with a moderate level of anxiety were most likely to take comprehensive precautionary measures against the infection [ ] . moreover, the use of personal protective equipment increases the discomfort level and causes difficulties in communication [ ] . there is a need of further research into the roles played by deteriorating physical and psychological health in the adoption of protective behaviors against covid- . physical symptoms and poor self-rated health status were significantly associated with a higher incidence of post-traumatic stress disorder and symptoms of stress, anxiety, and depression [ ] . both sleep problems [ ] and suicidal ideation [ ] are serious mental health problems in the era of covid- . it is reasonable to hypothesize that the deterioration of psychological health is significantly associated with sleep problems and suicidal ideation that have become more prevalent during the covid- pandemic, whether the deterioration of physical health is significantly associated with sleep problems and suicidal ideation bears further exploration. this study had three aims: ( ) to determine the proportion of individuals who reported the deterioration of physical and psychological health during the covid- pandemic in taiwan, ( ) to examine the association between cognitive and affective constructs of health beliefs and demographic characteristics and the subjective deterioration of physical and psychological health, and ( ) to examine the association between subjective deterioration of physical and psychological health and adoption of protective behavior against covid- and mental health problems. the current investigation was based on the dataset of the survey of health behaviors during the covid- pandemic in taiwan, which was comprehensively described elsewhere [ ] . briefly, a facebook advertisement was deployed between april and april . we targeted the advertisement to facebook users by location (taiwan) and language (chinese), where facebook's advertising algorithm determined which users to show our advertisement to. facebook users who were years or older and resided in taiwan were eligible for this study. participants reached the research questionnaire website through the facebook advertisement, which was composed of a headline, main text, pop-up banner, and weblink. a total of respondents completed the research questionnaire; of them, respondents were excluded due to missing data on any variable or being younger than . data from respondents were analyzed. figure demonstrates the flowchart of study design. the institutional review board (irb) of kaohsiung medical university hospital that is responsible for ethical review approved this study (kmuhirb-exempt(i) ). as participation was voluntary and survey responses were anonymous, written informed consent was waived based on the approval of irb. the participants were given no incentive for participation. we provided links to taiwan centers for disease control, kaohsiung medical university hospital, and medical college of national cheng kung university for participants to learn more about covid- at the end of the online questionnaire. the analyses of information sources [ ] , sexual behaviors [ ] , and sleep and suicidality [ ] using the dataset have been published elsewhere. facebook advertisement was deployed between april and april . we targeted the advertisement to facebook users by location (taiwan) and language (chinese), where facebook's advertising algorithm determined which users to show our advertisement to. facebook users who were years or older and resided in taiwan were eligible for this study. participants reached the research questionnaire website through the facebook advertisement, which was composed of a headline, main text, pop-up banner, and weblink. a total of respondents completed the research questionnaire; of them, respondents were excluded due to missing data on any variable or being younger than . data from respondents were analyzed. figure demonstrates the flowchart of study design. the institutional review board (irb) of kaohsiung medical university hospital that is responsible for ethical review approved this study (kmuhirb-exempt(i) ). as participation was voluntary and survey responses were anonymous, written informed consent was waived based on the approval of irb. the participants were given no incentive for participation. we provided links to taiwan centers for disease control, kaohsiung medical university hospital, and medical college of national cheng kung university for participants to learn more about covid- at the end of the online questionnaire. the analyses of information sources [ ] , sexual behaviors [ ] , and sleep and suicidality [ ] using the dataset have been published elsewhere. the four-item self-perceived health questionnaire was developed by ko et al. [ ] to evaluate the physical and psychological health of the public during the sars epidemic. for this study, the four questions were modified to evaluate the self-rated physical and psychological health of the respondent compared with those of other people before the covid- outbreak and during the week before filling out the questionnaire ("how is the state of your physical/psychological health compared with other people before the covid- pandemic/in the recent week?"). the questions are listed in table s . the rating for each question ranged from (much worse), (mildly worse), (the same), (mildly better), and (much better). then, the self-reported physical and psychological health states were compared between before and during the covid- pandemic. respondents whose self-rated physical health score in the preceding week was lower than that before the covid- outbreak were classified as having a deterioration of physical health during the covid- pandemic. the respondents whose self-rated physical health score in the preceding week was the same as or higher than that before the covid- outbreak were classified as having no deterioration respondents completed the research questionnaire respondents who were years or older and resided in taiwan completed the questionnaire without missing data data from respondents were analyzed respondents were excluded due to missing data or being younger than the four-item self-perceived health questionnaire was developed by ko et al. [ ] to evaluate the physical and psychological health of the public during the sars epidemic. for this study, the four questions were modified to evaluate the self-rated physical and psychological health of the respondent compared with those of other people before the covid- outbreak and during the week before filling out the questionnaire ("how is the state of your physical/psychological health compared with other people before the covid- pandemic/in the recent week?"). the questions are listed in table s . the rating for each question ranged from (much worse), (mildly worse), (the same), (mildly better), and (much better). then, the self-reported physical and psychological health states were compared between before and during the covid- pandemic. respondents whose self-rated physical health score in the preceding week was lower than that before the covid- outbreak were classified as having a deterioration of physical health during the covid- pandemic. the respondents whose self-rated physical health score in the preceding week was the same as or higher than that before the covid- outbreak were classified as having no deterioration in physical health. the respondents with or without a deterioration of psychological health during the covid- pandemic were classified according to the same rules. we examined the cognitive and affective constructs of health beliefs in the context of covid- , according to the particularization of the hbm to respiratory infectious disease pandemics [ ] . the four cognitive constructs included perceived relative susceptibility to covid- ("what do you think are your chances of contracting covid- over the next month compared with others outside your family?"), perceived severity of covid- relative to sars ("how serious is covid- relative to sars?"), sufficiency of knowledge and information about covid- ("do you think you have sufficient knowledge and information on covid- ?"), and perceived self-confidence in coping with covid- ("how confident are you that you can cope well with covid- ?"). the affective construct included worry about covid- ("please rate how worried you are toward covid- "). the questions, response scales, and dichotomous scales for statistical analysis are listed in table s . three questions developed in the study of tardy [ ] were used to assess the levels of perceived social support from families, friends, and colleagues during the preceding week ("in the past days, were you satisfied with the support from your ( ) family, ( ) friends, and ( ) colleagues or classmates?). the questions and response scales are listed in table s . the total score for the three questions indicates the level of perceived social support. higher scores represent higher perceived social support. the internal reliability (cronbach's α) of the measure was . in this study. as the scores of perceived social support were not normally distributed (skewness = − . , kurtosis = − . , p of kolmogorov-smirnoff test < . ), we used the median score of as the cutoff, and respondents whose score of perceived social support was lower than and whose score was or higher were classified as the groups of low and high perceived social support, respectively. we assessed whether the participants avoided crowded places, washed their hands more often, or wore a mask more often in the preceding week to protect themselves from contracting covid- ("in the past week, did you ( ) avoid going to crowded places, ( ) wash your hands more often, and ( ) wear a mask more often?") [ ] . the questions, response scales, and dichotomous scales for statistical analysis are listed in table s . respondents' level of general anxiety was assessed with the previously validated state-anxiety scale of the chinese version of state-trait anxiety inventory (c-stai), wherein respondents rate their feelings in response to general statements (for example, "i feel rested") [ , , ] . a previous study found that the state-anxiety scale of c-stai had a high internal consistency (cronbach's alpha = . , split-half reliability = . ) and high item-total correlations (r = . - . ) [ ] . two questions adopted from the revised -item brief symptom rating scale were used to assess sleep problems ("in the past week, did you have sleep problems?") and suicidal ideation ("in the past week, did you ever have suicidal thoughts?") in the preceding week [ , ] . previous studies confirmed that both questions had acceptable test-retest reliability (paired sample correlation coefficients = . - . ) and significant correlations with suicidal risk in general population (p < . ) [ , ] . the questions, response scales, and dichotomous scales for statistical analysis are listed in table s . data on gender (women vs. men), age, and education level (university qualifications or above vs. high school qualifications or below) were collected. as age was not normally distributed (skewness = . , kurtosis = − . , p of kolmogorov-smirnoff test < . ), we used the median age int. j. environ. res. public health , , of ( years old) as the cutoff, and respondents who were younger than and who were or older were classified as the younger and older groups, respectively. data analysis was performed using spss . statistical software (spss inc., chicago, il, usa). demographic characteristics, cognitive and affective constructs of health beliefs related to covid- , and perceived social support were compared between respondents who did or did not exhibit a subjective deterioration in physical and psychological health during the covid- pandemic using univariate logistic regression with the crude odds ratio (cor). furthermore, all potential predictive variables identified from the first step were eligible for inclusion in the multivariate logistic regression models with an adjusted odds ratio (aor) to determine the independent predictors of the subjective deterioration of physical and psychological health. the association between the deterioration of physical and psychological health and adoption of protective behaviors against covid- (avoiding crowded places, washing hands, and wearing a mask) and mental health problems (general anxiety, sleep problems, and suicidal ideation) was examined using multivariate logistic regression after controlling for the effects of gender, age, and educational level. moreover, p values, odds ratios (ors), and % confidence intervals (cis) of or were used to indicate significance. a two-tailed p value of < . indicated statistical significance. we also used the standard criteria proposed by baron and kenny [ ] to examine whether the associations of the deteriorated physical and psychological health and related factors (cognitive and affective constructs of health beliefs, perceived social support, adoption of protective behaviors, and mental health problems) were moderated by demographic characteristics that were significantly associated with the deterioration of physical and psychological health. the interactions (demographic characteristics × related factors) were selected into the logistic regression analysis to examine the moderating effects. data from respondents ( women and men) were analyzed. the mean age was . years (standard deviation [sd] = . years; range: - ), ( . %) participants were classified as the older group, and ( . %) participants had university qualifications or above. the mean scores for worry and self-confidence were . (sd = . ; range: - ) and . (sd = . ; range: - ), respectively. regarding the cognitive and affective constructs of health beliefs related to covid- , ( . %) respondents reported high perceived susceptibility to covid- ; moreover, ( . %) perceived that covid- was more harmful than sars, ( . %) reported having sufficient knowledge and information about covid- , ( . %) reported having high confidence in coping with covid- , and ( . %) reported having a high degree of worry about covid- . the mean level of perceived social support was . (sd = . ; range: - ), and ( . %) participants were classified as the group of high perceived social support. table shows the proportions of the respondents with various levels of subjective physical and psychological health and changes in health from before to during the covid- pandemic. most of the respondents reported their health the same as other people before (physical: . %; psychological: . %) and during the covid- pandemic (physical: . %; psychological: . %). regarding the changes in health from before to during the covid- pandemic, . % and . % of the respondents reported no change in physical and psychological health, respectively. of those who had changes in physical and psychological health, most reported mild deterioration (physical: . %; psychological: . %) or improvement (physical: . %; psychological: . %). in total, ( . %) and ( . %) respondents reported that their physical and psychological health deteriorated during the covid- pandemic, respectively. table presents the results of the univariate logistic regression model examining the associations between demographic characteristics, cognitive and affective constructs of health beliefs related to covid- , perceived social support, and the subjective deterioration of physical and psychological health. participants who reported higher perceived harm with respect to covid- than to sars all variables that were significantly associated with the subjective deterioration of physical and psychological health during the covid- pandemic in the univariate logistic regression model were included in the multivariate logistic regression models ( table ). the results indicate that participants with higher perceived harm from covid- compared with sars (b = . , aor = . , % ci: . - . , p = . ) and sufficient knowledge and information about covid- (b = . , aor = . , % ci: . - . , p = . ) were more likely to report the subjective deterioration of physical health during the covid- pandemic because both b values were larger than zero. the moderating effects of age on the associations between perceived harm of covid- relative to sars, sufficiency of knowledge and information about covid- , confidence in coping with covid- , and perceived social support with the deterioration of physical health were further examined based on the criteria proposed by baron and kenny ( ) . the results demonstrate that the interaction between age and sufficiency of knowledge and information about covid- was significantly associated with the deterioration of physical health (b = − . , aor = . , % ci: . - . , p = . ), indicating that age moderated the association between the deterioration of physical health and sufficiency of knowledge and information about covid- . further analysis found that the significant association between the deterioration of physical health and sufficient knowledge and information about covid- existed only in younger respondents (b = . , aor = . , % ci: . - . , p = . ) but not in older ones (b = . , aor = . , % ci: . - . , p = . ). the moderating effects of gender and age on the associations between perceived harm of covid- relative to sars, worry about covid- , and perceived social support with the deterioration of psychological health were also examined. the results demonstrate that the interactions between age and other factors were not significantly associated with the deterioration of psychological health, indicating that age did not moderate the associations between the deterioration of psychological health and other factors. regarding the adoption of protective behaviors against covid- , respondents ( . %) reported avoiding crowded places, ( . %) washed hands more often, and ( . %) wore a mask more often. table demonstrates the results from examining the association between the deterioration of physical and psychological health and the adoption of protective behaviors against covid- . the results indicate that after controlling for the effects of demographic characteristics, the subjective deterioration of psychological health was associated with more adoption of two protective behaviors, including avoiding crowded places (b = . , aor = . , % ci: . - . , p = . ) and wearing a mask (b = . , aor = . , % ci: . - . , p = . ). the interactions between demographic characteristics and the deterioration of psychological health were not significantly associated with avoiding crowded places, indicating that demographic characteristics did not moderate the associations between the deterioration of psychological health and avoiding crowded places. no significant association was found between the deterioration of physical health and adoption of protective behaviors against covid- . regarding mental health problems, respondents ( . %) had a high level of general anxiety, ( . %) had sleep problems, and ( . %) had suicidal ideation. the results from examining the association between the deterioration of physical and psychological health and mental health problems are shown in table . the results show that after controlling for the effects of demographic characteristics, the deterioration of both physical and psychological health was associated with more general anxiety (physical: b = . , aor = . , % ci: . - . , p < . ; psychological: b = . , aor = . , % ci: . - . , p < . ). the deterioration of psychological health and not physical health was associated with more sleep problems (b = . , aor = . , % ci: . - . , p = . ). the interactions between gender and the deterioration of physical and psychological health were not significantly associated with general anxiety. the interaction between age and the deterioration of psychological health was not significantly associated with sleep problems. the results indicate that neither gender nor age moderated the association between the deterioration of health and general anxiety and sleep problems. the deterioration of physical or psychological health was not significantly associated with suicidal ideation. before discussing the results, some issues related to the method of recruiting participants using the facebook advertisement warrants discussion first. recruiting participants through facebook can deliver large numbers of participants quickly, cheaply, and with minimal effort as compared with mail and phone recruitment [ ] . facebook is a platform that provides the opportunity to assess the general public during fast-moving infectious disease outbreaks. however, facebook users may not be representative of the population. a review of a study that recruited respondents through facebook reported a bias in favor of women, young adults, and people with higher education and incomes [ ] . the gender disproportion of the respondents also existed in the present study. to control the effect of gender, gender was used as the covariate when we examined the associations between the deterioration of health and the adoption of protective behaviors and mental health problems. moreover, the present study examined the moderating effects of gender. however, the nonrepresentation of the population in the study should be cautiously considered, and is a consequence of using social media to recruit the participants. this study found that . % and . % of respondents reported experiencing a deterioration of physical and psychological health during the covid- pandemic, respectively. according to the statistics of the national health insurance administration, taiwan, the numbers of patients visiting health care facilities during the period of april to june in reduced . % when compared with the same period in [ ] . people with chronic illnesses may worry about contracting covid- in hospitals and doctor's offices and therefore not seek medical assistance and delay treatment. people with anxiety may interpret changes in perceived bodily sensations as symptoms of being ill, related or unrelated to covid- , and complain of deteriorating physical and psychological health [ ] . although taiwan was not placed under lockdown, people may have reduced outdoor activities or stopped routine exercise due to the worry of contracting covid- and the burden of physical and psychological health problems may have therefore increased [ ] . the results of this study indicate that in addition to monitoring health states of people who are quarantined or have contracted covid- , it is necessary for the governments and health professionals to early detect health problems of and timely deliver medical assistance to the public in the pandemic. introducing novel methods of clinical interaction, such as telemedicine and the use of electronic devices for covid- education, self-assessment, and maintenance of a symptom diary may assist in overcoming the mounting challenges of the covid- pandemic [ , ] . health promotion strategies directed at adopting or maintaining positive health-related behaviors should be utilized to address the increase in psychological distress during the pandemic [ ] . moreover, promoting community-supported interventions for stress and anxiety due to covid- is recommended [ ] . this study found that the perceived harm from covid- , more than that from sars, was significantly associated with the subjective deterioration of physical and psychological health during the covid- pandemic. the perceived risk of contracting covid- may cause stress, which may compromise physical and psychological health [ ] . the public evaluates the risk of covid- relative to sars based on the information they receive from the media and social networks. this study also found that self-rated knowledge and information about covid- were positively associated with the deterioration of physical health. the provision of timely and accurate information on covid- is fundamental to mitigating the disease [ ] and for rationally understanding covid- . moreover, high confidence in coping with covid- was negatively associated with deterioration of physical health. helping build confidence to successfully cope with the pandemic by delivering information through traditional and social media should be a priority for governments and health professionals. however, controlling misinformation on covid- remains a challenge. this study found that perceived social support was negatively associated with the deterioration of physical and psychological health. good social interactions not only provide emotional support but also daily necessities, which may contribute to the maintenance of physical and psychological health. for example, social support can increase individual capacity to maintain health behaviors [ ] . a study on women's sport practice in spain found that brothers/sisters, best friends and workmates encourage women to practice exercise; in particular, the presence of supportive friends increases with age [ ] . social support may be attenuated due to social distancing according to the health policy requirement and the fear of contracting covid- . social support can be offered through telecommunication instead of physical contact to those who have been quarantined to prevent mental health problems. the governments should take an initiative to provide support for those who were socially isolated before the pandemic. this study found that the respondents who reported deteriorated psychological health were more likely to avoid crowded places and wear masks. the results of previous studies were mixed. a study in cyprus found that higher anxiety was positively associated with the adoption of measures related to personal hygiene, whereas higher depression was negatively associated with higher compliance with precautionary measures [ ] . a study in china during the initial outbreak of covid- demonstrated that the adoption of precautionary measures was associated with a lower psychological impact from the outbreak of covid- and lower levels of stress, anxiety, and depression [ , ] . another study in china found that people's perceptions that the outbreak can be controlled by protective behaviors were associated with lower prevalence of depression and anxiety [ ] . the results of the present and previous studies indicate that there might be factors such as the timing of survey, severity of the pandemic and definition of psychological health influencing the association between psychological health and adoption of protective behaviors. this study found that the deterioration of both physical and psychological health was significantly associated with general anxiety and that of psychological health with sleep problems. general anxiety is closely connected to dysfunction of interoception, which can disturb the process by which the nervous system senses, interprets, and integrates signals originating from within the body, providing a moment-by-moment mapping of the body's internal landscape across conscious and unconscious levels [ ] . somatic discomfort, such as increased muscle ache and heart rate, and psychological discomfort, such as excessive worry and irritability were also the core symptoms of generalized anxiety disorder [ ] . therefore, general anxiety and the perception of deteriorating health may occur together. moreover, the present study found that deteriorated psychological health was significantly associated with sleep problems. sleep disturbance is the core symptom of several mental disorders; for example, depression and anxiety disorders [ ] . sleep problems may be used as an indicator of psychological health and may warrant psychological intervention during the covid- pandemic. the present study has some limitations in addition to the gender nonrepresentation of the participants recruited by the facebook advisement. first, there might be recall bias for the health state before the covid- outbreak. second, the cross-sectional design of this study limited causal inference between changes in health state and related factors. third, some factors such as chronic diseases that might influence deteriorated health in the covid- pandemic were not examined in the present study. fourth, the psychometric measures used in the present study for evaluating perceived social support warrants further examination. this facebook-based online study on the general public in taiwan found that . % and . % of respondents reported deteriorated physical and psychological health during the covid- pandemic, respectively. both subjective deteriorations of physical and psychological health positively related to general anxiety. the results indicate that the physical and psychological health of the public, but not only those who were contracted with covid- , should be focus of health professionals' concern. the present study identified several health belief constructs, social support and demographic characteristics that were significantly associated with deteriorated physical and psychological health. these factors can be used to screen for the individuals who need intervention for physical and psychological health problems. the subjective deterioration of psychological health was significantly associated with avoiding crowded places and wearing a mask. further study is needed to examine the mechanism accounting for the association and provide reference for developing strategies to promote adoption of protective behaviors against respiratory infectious diseases. funding: this research did not receive any specific grant from funding agencies in the public, commercial, or nonprofit sectors. the authors declare no conflict of interest. the outbreak of covid- coronavirus and its impact on global mental health preventing suicide in the context of the covid- pandemic the socio-economic implications of the coronavirus pandemic (covid- ): a review covid- -related school closings and risk of weight gain among children impact of the covid- pandemic on mental health and quality of life among local residents in liaoning province, china: a cross-sectional study the traumatic 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true, as the philosophers say, that life must be understood backwards. but they forget the other proposition that it must be lived forwards. when the last editorial was written just weeks into the s and the emergence of a new strain of coronavirus in china was noted, little did any of us imagine the devastating e ect this would have on the entire globe. in october , ian goldin in future opportunities, future shocks warned 'our world will change more this century than during any other time in human history. change will happen faster than ever before. it will also a ect more people than ever before'. goldin identified 'supply chain risk, cyber security and risks to physical infrastructure, natural disasters and climate change as the major systemic risks with aftershocks potentially felt far away from any given epicenter'. he goes on to warn that, 'while all of these risks are severe, none is as threatening as the specter of a virulent, deadly global pandemic. in terms of likelihood and potential damage that may be caused, pandemics pose a significant risk to both global health and economic stability'. six years on and this has come to pass. modelling, r , flattening the curve, herd immunity, are now part of the general public's everyday parlance. however, while the scientists, politicians and journalists have familiarized the public to the jargon, they have not always explained the nuances and the context-for examplenumbers as opposed to rates, the issues of the importance of a denominator when presenting data, the concept of excess winter deaths or even the vagaries and pros and cons of mathematical modelling. we have had epidemiologist of every hue and persuasion putting forward their interpretations and views, journalists asking banal and repetitive questions at the daily uk press conferences and the mantra of 'stay home, protect the nhs, save lives' being repeated in response to the majority of questions. this is not the time to apportion blame though and as the swedish state epidemiologist, anders tegnell said in an interview on bbc radio this is a new virus, di erent countries are dealing with it in di erent ways. it will be a while before we can learn which approach or combination of approaches was the most e cient and e ective in dealing with the pandemic. in this issue, there are articles on a range of public health issues including two systematic reviews: one reviewing the association of smokeless tobacco and cerebrovascular accident and the other a review of physical and psychological health and wellbeing of older women in sub-saharan africa. langthorne and bambra used archival methods to examine local health inequalities during the s period of austerity. the insights should contribute to understanding the impact of recent austerity policies on health inequalities. the public health ethics collection is very welcome and timely, the articles include thought provoking and learned articles from eminent scholars working in public health ethics and law. in the online articles related to covid- , miglietta and levi document the circulation of covid- in florida, usa, since february . bäuerle et al . make the point that while 'little is known about treatment options and potential vaccinations to e ectively combat covid- , the same applies to the impact of covid- on people's mental health'. rufai and bunce in their article analysing the content of world leaders' usage of twitter in response to the pandemic warn that while twitter may be a powerful tool, caution needs to be exercised when using twitter for health information. 'lessons learned' is a rather over used and perhaps trite phrase. however, now is possibly the time to learn lessons from the experiences of living through a pandemic. looking ahead and planning for the future is presently a necessity. at the time of writing this editorial, the countries that seem to have tackled the pandemic are those with good leadership-germany and new zealand are two of the examples cited. the small state of kerala in south india has received international praise for the 'kerala model' of dealing with covid- ; 'the system had e ective protocols in place, and stuck to the time-tested strategy of case isolation and contact-tracing, combined with an alert community surveillance system'. kerala seems to have learned lessons from the experience of dealing with the nipah outbreak in . the internal migrants (called guest workers) who are a significant economic force in the state were treated with respect and consideration and provided with appropriate facilities during the lockdown. the consensus is that kerala's success was due to the strong leadership provided by its chief minister pinarayi vijayan. this is in sharp contrast to brazil (not having learnt any lessons from the outbreak of zika in the country) dealing with the pandemic under the leadership of jair bolsonaro. in the uk, the pandemic has brought into focus the running down of health and social services and the widening of inequality following austerity. any semblance of austerity appears no longer present and the uk chancellor seems to have thrown open his co ers for the greater good. while international agencies like the who have played their part in eradicating diseases in the last century, as goldin points out, 'their mandates have mushroomed and their capabilities have not evolved as quickly as the challenges they face'. the solution lies not in abolishing these institutions but reforming and reframing them to enable them to undertake their roles and responsibilities e ectively in the st century. in the commentary (in the ethics collection) entitled 'global health without justice or ethics', venkatapuram argues that the 'singular failure of philosophers and global health policy planners and practitioners has been our failure to create and engender moral motivation, a will-among those who are able-to prevent millions of human deaths and create conditions for good health within and across countries'. the term global village seems more applicable now than ever before. looking back to understand, learn lessons, reflect and reprioritise should go some way to facing the post covid future. future opportunities, future shocks key trends shaping the global economy and society, citi gps: global perspectives & solutions association of smokeless tobacco and cerebrovascular accident: a systematic review and meta-analysis of global data sarah, a systematic review of physical and psychological health and wellbeing of older women in sub-saharan africa health inequalities in the great depression: a case study of stockton on tees, north-east england in the s documented early circulation of coronavirus disease (covid- ) in florida, usa, since psychological support in times of covid- : the essen community-based cope concept catey bunce world leaders' usage of twitter in response to the covid- pandemic: a content analysis opinion-coronavirus outbreak-how the indian state of kerala flattened the coronavirus curve key: cord- - uvb qsk authors: tanveer, faouzia; khalil, ali talha; ali, muhammad; shinwari, zabta khan title: ethics, pandemic and environment; looking at the future of low middle income countries date: - - journal: int j equity health doi: . /s - - -z sha: doc_id: cord_uid: uvb qsk covid- which started in wuhan, china and swiftly expanded geographically worldwide, including to low to middle income countries (lmics). this in turn raised numerous ethical concerns in preparedness, knowledge sharing, intellectual property rights, environmental health together with the serious constraints regarding readiness of health care systems in lmics to respond to this enormous public health crisis. from the restrictions on public freedom and burgeoning socio-economic impacts to the rationing of scarce medical resources, the spread of covid- is an extraordinary ethical dilemma for resource constrained nations with less developed health and research systems. in the current crisis, scientific knowledge and technology has an important role to play in effective response. emergency preparedness is a shared responsibility of all countries with a moral obligation to support each other. this review discusses the ethical concerns regarding the national capacities and response strategies in lmics to deal with the covid- pandemic as well as the deep link between the environment and the increasing risk of pandemics. like the previous outbreaks of coronaviruses i.e. severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers), the ongoing pandemic covid- has characterized that the infectious diseases represent a problem that does not recognize borders, race, ethnicity, religion, caste or any other status quo. now known as "covid- ", "sars-cov- ", " -ncov", the virus has already made a huge impact on a global scale [ ] and changed human ways of thinking and characterizing the problem. covid- is an issue beyond borders, thus necessitates a globally coherent, combined, inclusive and holistic approach which can help in the reduction of transmission and overall risk mitigation, which otherwise, is predicted to impact entire human race. according to the who situational report on th april, , the total number of global cases surged up to , , [ ] , with almost every country affected or threatened by the geographical expansion of sars-cov- . the grand total of the total infections as of th sept, , is , , with death toll of , [ ] . a summary of the statistics taken from the who showing the data of th april and th september is indicated in inset fig. revealing the regional distribution of the sars-cov- cases and rate of mortalities. international regimes are on high alert to stop its spread, however, as far as the global scenario is concerned, countries and governments are clueless in stopping the expanding pandemic as not much is known about sars-cov- , while left only with implementing nationwide lock downs and curfews which opened new economic fronts and social challenges. one of the major challenges is the intermittent psychological burden on segments of the society who have not been well versed with the scientific knowledge. rumors and false information through social media brings enormous mental distress and singles out the need for responsible information sharing. similarly, the deepened cultural norms that people find difficult to abandon in lmics has created situations more favorable for transmission of sars-cov- , with the religious fundamentalists also playing their part. zoonotic origins of the coronaviruses and their circulation in the intermediate animal hosts presents another challenge of sustaining biodiversity and human-animal relationships. the primary reservoir of the sars-cov were bats while the intermediate source was civet cats that expanded across countries in - . mers-cov jumped to humans from camels and possessed an exceptional fatality rate of % in . now, sars-cov- has been proposed to jump to human beings from bats and pangolins [ , ] . the ongoing pandemic has resulted in a situation in which the scale of emergency is similar to world war ii (ww-ii), requiring decisiveness and commitment [ ] . in the developing and under developed regions, the risk management is extremely challenging because of the resource limitation as well as lack of basic health necessities and poor sanitation etc. [ , ] . it is now established that the oral-fecal route of transmission of sars-cov- is also possible beside respiratory droplets and person to person contact which further multiply the complexities of sars-cov- for less advanced regions [ , ] . apart from the lack of resources and technology, negligence due to the lack of awareness presents a grim picture. covid- has unleashed an enormous psychological burden that may have long term detrimental consequences. covid- has presented itself as a test case for the humanity in terms of global fraternity, decision making, technology and expertise sharing, rapid pandemic response mechanisms, stability, crises management and policy making. it is of paramount importance that the decisions regarding covid- pandemic should be strictly governed by ethical and moral principles. a shared threat cannot be defeated without a combined response. keeping in view the significance of the current situation, we have attempted to discuss various issues from the lens of ethics with special reference to the developing and under developing regions. covid- pandemic is an unprecedented situation facing the world in current times, with large, unimaginable socio-economic impacts. in such a situation, pandemic preparedness and response efforts require careful analysis of core ethical values and principles with an informed and evidence-based decision making. the ethical aspects that require special consideration include the greater need for public engagement, disease surveillance, clinical research and novel experimental interventions. the moral obligations in relation to "duty to treat" and "duty to plan" must consider the rights of health care workers and affected communities. moreover, necessary measures should be taken with respect to allocation of scarce resources, priority setting and social distancing [ ] . the decision making process for outbreak preparedness planning involves a number of stakeholders including governments, ngos, the military, commercial businesses, research funders, academic institutes, public health officials, researchers, ethicists, health care workers, volunteers, communities and families. all of them have different moral or legal obligations to fulfil [ ] . in a public health emergency, it becomes difficult to keep a balance between competing ethical principles i.e. need for necessary interventions in the interest of public health without compromising the public liberty. measures that limit individual rights must be reasonable, proportionate, least-restrictive, impartial, non-discriminatory, and in accordance with national and international regulations [ ] . when thoroughly implemented, home quarantine orders by government are legal and effective, as long as individual freedom and privacy is respected [ ] . the principal of equal respect must be implied by decision makers when a lock down or quarantine is imposed on the public. hereby restricting the public right to freedom is to be reciprocated by readily providing their basic needs, by ensuring effective risk communication through ethical and logical backing of this decision and giving easy access to latest information about the uncertain, ever changing risks [ ] . resource allocation should be ethical, transparent and based on scientific evidence. in this regard, the primary obligation is to protect front line health care workers as the entire health care systems depends on these individuals. furthermore, public health measures should focus on prioritizing the provision of resources when and where required e.g. to the public in confined settings which are prone to rapid spread of disease (such as homeless shelters, prisons, and slum areas), to areas with localized outbreaks to control community transmission and to high-risk groups such as older people, people with co-morbidities and weekend immune systems [ ] . health equity i.e. equal health opportunities for all should be the focus of all health policies planned by the state actors to better prepare a country's health system in the face of current pandemic or any health crisis that may come in future [ ] . during a pandemic, issues of resource scarcity can be mitigated to a large extent if early public health interventions are introduced e.g. through social distancing which is crucial in reducing pressure on the health system. this is particularly important with regard to resource constrained settings such as those in low to middle income countries (lmics). the failure to contain the spread at an early stage can severely constrain the health system's capacity in these countries. access to scarce resources which is considered reasonable in one country may be different in another such as in the case of developed and developing countries. particularly in developing countries, the public should be well informed about decisions regarding allocation of limited resources with clear communication of proper justification to gain trust and avoid chaos [ ] . resource scarcity may also be encountered at the global level. lower-income countries may face more scarcity than developed countries in countering covid- spread. hoarding of important medical supplies such as personal protective equipment and inaccessibility of vaccines and treatments when made available, should be discouraged by developed countries or the countries where they happen to be produced [ ] . ethical aspects must also be considered in covid- pandemic research policy and practice. it is an ethical obligation to conduct research in infectious disease outbreaks needed to address pertinent research questions that arise during such a health crisis [ ] . according to nuffield council on bioethics, the core values of ethical research include helping reduce suffering, demonstrating equal moral respect for the communities involved and fairness in terms of benefit sharing. the ethical principle of helping reduce suffering provides the basis for prioritization of more valuable and much needed research during a public health emergency such as covid- [ ] . for example, conducting rapid review of research proposals becomes all the more important during a pandemic. however the decision of ethics review committees (ercs) should not be too hasty so as to avoid approval of mediocre or non-pertinent research at the same time ensuring a speedy review to facilitate important research. in these circumstances, standard operating procedures (sops) could be introduced to form a multi-disciplinary sub-committee composed of members from erc who could be immediately called in times of emergency to conduct rapid reviews [ ] . to make the process more rapid, technological interventions should be encouraged. an erc in a chinese hospital used the video conference to review batches of research proposals. moreover, these conferences were held more frequently during the corona virus pandemic than they normally did. the mean time between receiving the application and initial review decision was . days [ ] . ethical principle of fairness entails the equitable sharing of benefits and the burdens of research between different actors involved in research i.e. the participating community as well as the collaborating partners from low and high resourced settings. similarly, the principle of equal respect emphasizes respectful relationships between researchers and the affected communities going through the emergency for meaningful community engagement. with respect to health care workers and researchers, the employers and the funders are responsible to make sure their needs are met as an equal moral obligation in exchange for their services [ ] . science and technology should be at the forefront of the outbreak research ranging from health sciences including risk assessment, risk management, vaccine development and modelling studies for improved data analysis to social sciences fighting discrimination/violence and promoting human rights [ ] . in contrast to research and development (r&d) focused on medical care and treatment, less attention is given to the improvement of coordination in assessment and modelling studies on data generated during an outbreak. integration of data analysis generated across disciplines is critical to provide support to decision makers during a pandemic in order to understand the course of the outbreak, the risk of its spread, and the potential effects of infection control measures [ ] . this should be given due share in research practice during a pandemic. ethical standards also advocate the notion of "duty to care" and "duty to treat" by health care professionals during pandemics. supporting arguments in relation to professional duty in the face of uncertainty and risk to life are guided by ethical principles of virtue, generosity and social utility [ , ] . besides, in dealing with this covid- crisis, health care workers may have to take difficult decisions based on a utilitarian approach when faced with ethical dilemma of managing critical care resource allocation. keeping in view the uncertainty surrounding this novel outbreak, rationing of resources might be required for a much longer time period and a far larger number of people. the response decision may require shifting from providing all the patients the maximum number of available resources to allocating minimal resources necessary for an individual's survival. so that the additional resources are left out for others who may have an equal chance of a good outcome [ ] . this is where governments and health care departments are obliged to guide and provide training to health care workers to handle difficult situations. furthermore, ethical practice emphasizes the duty to plan where proactive planning by the public health leaders and health professionals to prepare beforehand can help reduce morbidity and mortality in a worst case scenario. the aim is to have a system in place across all levels of health care to maximize benefits to the community in the time of need [ ] . besides being an expanding pandemic, sars-cov- is accompanied by huge chunk of information floating through the social, electronic and print media making it the surge for authentic information and news much harder, as iterated by the who and unicef [ ] . while people must rely on authentic data, the news spread through social media platforms often masks the original news/statistics. the tsunami of in-correct information and rumors has appeared as a major concern. the focus should be on awareness regarding sars-cov- and not on overburdening people with psychological distress which may lead our way to a psychological pandemic. one of the key steps to reduce the spread of misinformation is to automatically direct the users seeking information to who when keywords like coronavirus, covid- , pandemic etc. are searched on the online platforms. the only way in which traditional media will be helpful in fighting the expansion of the sars-cov- pandemic is through responsible reporting and sharing so that the information trickles down to common people. in pandemic of this global scale, media can be used as a source to mobilize communities to help the underprivileged segments of the society by keeping with the general safety protocols. team of social media experts linked to the official sources can be helpful in diffusing correct information across the social media platforms. evidence based information can be sought through the country specific official advisories and who. limiting ones information resources can be helpful. media giants must be adhered to strict norms of not to create panic but spread awareness. environmental ethics, climate crises and covid- : preparing for the worst covid- pandemic is an example of complex threat to humanity from emerging and re-emerging pathogens and signifies the need for a holistic and integrated one health approach for reducing their risk [ ] . one health approach is characterized by the inter dependence of human, animal and environmental health [ ] . both the animals and environment have a significant role in the emergence of infections with zoonotic origin in human population. several factors like climate crises, increased travelling, population explosion, urbanization, deforestation, animal trade and rapidly evolving pathogens have further amplified the threat of emerging zoonosis. due to evolutionary pressures and acquiring mutations, previously an animal pathogen, now gains the ability to cross the specie barrier, jumping and adapting to a new host i.e. human, which happened in case of sars, mers and now covid- [ , ] . circumstantial evidence suggest that the pandemic started in the seafood market which was a hotspot for buying and selling animals like bats, snakes, poultry etc. and provided sufficient humananimal interaction leading to spillover. initial studies on the genome of sars-cov- reveals . % similarity with bat coronaviruses leading to the conclusion that these viruses emerged from horseshoe bats [ ] . studies also revealed pangolins as one of the possible intermediate host [ ] . these converging evidences signify the need for one health approach. increasing demand for urbanization has led to human encroachment of more and more natural habitats, thereby, increasing exposure to novel exotic pathogens from the wild. a rapid consensus is building among the scientific community which infer the transition from holocene era to anthropocene era on the geologic time scale, in which human species are involved in changing the geology of the planet through anthropogenic activities [ ] . as a consequence of plastic pollution, distribution of radioactive material across the planet, co emissions, mining, deforestation and the sea level rise, the global ecosystem is becoming destabilized with time and threatens the animal species in the wild which may otherwise serve as a buffer between human and animals for harboring deadly infections. extinction of megaflora and megafauna signifies the need of exclusive one health strategies to combat this ever expanding threat. the emerging diseases and climate crises cannot be separated and requires extensive research, funding and attention of the international leaders. climate action cannot be shelved even in the pandemic as it is one of the tools for mankind to fight the emerging and re-emerging pathogens. figure indicates a holistic perspective of the sars-cov- pandemic while fig. illustrates the one health concept. adding more to the role of the environment, it is pertinent to mention that the developed countries are the major contributors towards the greenhouse gas emissions leading to global warming and climate change. this raises an ethical dilemma as most of the countries affected as a result of these changes are contributing negligible amount of green house gases (ghgs) but often become the adversely affected. the burden of responsibility regarding contributions to the climate change in relation to the pandemic needs significant discussions and dialogues. ethical issues concerning covid- outbreak: situational analysis in low to middle income countries (lmics) pandemic response should be guided by the ethical principles of fairness, respect and transparency. however, outbreaks are more often confronted with fear, discrimination, and interventions lacking evidence which raises public health concerns [ ] . in this section, we discuss the ethical challenges faced by low to middle income countries as they struggle to respond to the escalating spread of covid- . based on the idea that no "one size fits all", it is important to consider how the cultural and economic values in these countries impact approaches to address the corresponding ethical issues [ ] . figure indicates the issues in the lmics regarding global health emergencies using an ice berg analogy. various ethical dilemmas arising from the current situation are indicated in fig. . rapidly growing contagion in less developed countries mainly in africa, asia and certain parts of the americas is a global health emergency. different countries require a context-specific response depending upon their current situation whether there are no cases, infrequent cases, clusters or local transmission. overall, decisive actions necessitate effective social distancing, quarantines and if required even lock downs as well as massive testing and systematic contact tracing to stop further spread. developing and least developed countries are the most vulnerable to this crisis, many of which are affected due to war conflicts, are overly populated with urban areas and slums, lack access to basic health services and are thus at high risk of covid- spread [ ] . in lmics, the greatest challenge is how fast the gaps in early response to covid- outbreak are filled before the infection control goes out of hand. the best chance is to have the systematic containment measures in place and massive testing done before the virus overwhelms the weaker health care systems. a well-organized response should also incorporate scientific knowledge generation e.g. studies on changing disease epidemiology such as duration of incubation period between infection and appearance of first symptoms so the people are retained in quarantine no longer than it is necessary in order to keep the costs down [ ] . moreover, rapid and actionable research conducted at local level should be encouraged in lmics so as to deal with the pandemic more effectively. data generated from response activities can be utilized for research purposes to make foreseeable predictions in the local context [ ] and change the ongoing response strategies as and when required in order to minimize socio-economic impacts. response preparedness is weak in many low income countries as evident by preparedness assessments of countries, none of which were evaluated as ready to respond, making them predominantly susceptible to epidemics. it is due to the poor health and nutrition conditions, aggravated by co-morbidities and low average annual health spending of only $ per person in these countries. according to who, the regional readiness level is assessed to be only % with serious gaps in the response capacities for these countries to investigate disease spread alerts, treatment of patients in quarantine facilities and transmission control in both the health facilities and the public [ ] . south asia which holds a quarter of the world's population with currently covid- affected countries including afghanistan, pakistan, india, nepal, bangladesh, sri lanka are likely to face severe constraints in the management of the outbreak if it spreads uncontrollably. the current low number of reported cases may be due to less testing with limited resources in these countries. for example, india's testing rate is exceptionally low given its large number of population with an average of just over tests per million persons which is way less than advanced countries like south korea with more than and italy more than tests per million persons, as of march , [ ] . total cumulative corona cases in india were reported to be , , while the death toll has risen to , , as of th september [ ] . pakistan reported its first coronavirus case on february , . there were confirmed cases and deaths, as of april , . the weekly report of th to th september by who reveals a total of , cumulative cases of sars-cov- in pakistan, with cumulative deaths [ ] . initially, the country's response was appropriate and timely just when the virus was already spreading from china to its neighboring countries due to travel. the containment measures proved effective in preventing the import of virus from china. later, when a considerable number of people travelled back from neighboring iran which was badly affected by the virus, the whole dynamics changed for pakistan. partial or complete lockdowns were imposed throughout the country, and all businesses apart from those providing essential goods were closed [ ] . the government estimated that the number of cases were expected to rise up to , by april , in a national action plan report submitted to the supreme court [ , ] . however, the lockdown situation was gradually eased with implementation of "smart lockdowns" and reopening of the economy in stages. afghanistan, a war-torn nation started to feel the brunt of covid- just like its neighbors. controlling its spread in afghanistan is governed by a number of social and political complexities, including the incursion of afghan refugees from neighboring iran. less public awareness of the virus and lower health literacy is a major issue illustrated by an individual who was confirmed to have the virus, and people who were the potential suspects, left the quarantine facility, risking the virus transmission in the communities [ ] . the cumulative deaths in afghanistan have risen to while the total reported cases are , as of th sept. [ ] . iran faced the worst situation among lmics and was the epicenter of corona virus in asia with over , confirmed cases and over deaths as of april , . as of th sept. , the total number of reported cases are , and cumulative deaths are reported to be , in iran [ ] . the iranian government was criticized for failure to respond early which resulted in shear increase in the number of cases, affecting both citizens and several top officials [ ] . also, insufficient public awareness regarding risk of the virus, and poor public attitude in observing self-quarantine were attributed as reasons for higher rate of spread [ ] . in addition to resource limitations, us sanctions on iran even increased the difficulty in procurement of medical supplies from companies abroad. it is due to the stricter sanctions imposed by us since may, with severe penalties for non-us firms doing business with iran. this is a humanitarian crises and the global community must look at the impacts of such sanctions on humanitarian aid during a pandemic so that the sufferings of the public could be reduced [ ] . some countries also faced challenges in implementation of ongoing lockdowns due to religious or cultural values such as religious congregations [ ] . congregations in pakistan, malaysia and india were considered responsible for transmission of the virus. pakistan reported hundreds of cases directly linked with the congregation which was held in march at raiwind, lahore [ ] . developing and less developed countries also face several challenges in self-quarantine which might not be very effective where large families live together often in congested settings, sometimes three or more people sharing the sleeping quarters. households in sierra leone, tajikistan, guinea, pakistan, afghanistan, and senegal are the largest, with six or more members on average [ ] . in africa, the first case was confirmed in egypt on feb , . according to the recent data of who available on th sept. , the total number of cases has risen to , , with the death toll rising to , in african continent, with south africa affected the most [ ] . the covid- outbreak continues to spread across africa with a number of countries in the continent where community transmission is becoming established such as south africa. african countries are more vulnerable to faster spread of covid- due to weak health care systems, high occurrence of hiv and malnourishment among other factors such as scarcity of medical supplies for personnel and the patients [ ] . resource constrained countries in africa, should take steps for prepardeness and development of basic technological interventions for responding to health emergency [ ] . the who african regional office along with cdc immediately started taking measures to prepare african countries for covid- outbreak. the previous experiences from ebola preparedness came handy as coordination response mechanisms were already in place. over the past few years, the who has helped develop a national network of surveillance laboratories and health facilities in the african region amidst the previous outbreaks which could prove really helpful in current crisis [ ] . the rapid response measures taken in china and other countries like taiwan, hong kong, singapore and south korea ranged from strict quarantine measures, to detailed contact tracing, augmented with use of big data analytics. these measures helped the countries in keeping down the number of growing cases by breaking the chain of transmission. taiwan leveraged all the technological resources, integrating national health insurance and immigration and customs databases to generate big data for tracing potential cases or areas [ ] . the impacts of these early interventions for effective response towards covid is encouraging for the countries where covid- is spreading fast. effective public engagement should be made meaningful through gaining public trust and seeking cooperation instead of using the coercive measures especially in resource constrained settings with low level of literacy and social, religious and cultural complexities. only this way, the lockdowns or quarantine measures will be more effective [ ] . effective risk communication is mandatory in public health response measures taken in lmics ensuring the public's right of access to information. poor populations without access to information channels are the most vulnerable during health crisis and are most likely to ignore the government's warnings regarding the precautionary measures such as social distancing [ ] . a larger population of lmics is living without access to mass media in rural areas or some poor countries such as madagascar, nigeria, zambia etc. [ ] . awareness about the risk can be spread through simple health messaging and regular briefings by the government on television and radio; through public officials at the district level; or any other means deemed appropriate so as to provide access even to the poorer communities living without internet or communications channels. it is the government's obligation to keep the public well informed about the risk of covid- . it also means that governments may have to take difficult decisions given the uncertainty and time constraints surrounding this pandemic. therefore, it is important that information must be communicated in a transparent, honest and timely manner [ , ] . scarcity of resources including trained personnel, health centers, and protective gears is a major problem in lmics. even under normal circumstances, the poorest countries have acute shortage of icu beds in comparison to high income countries e.g. roughly us has icu beds per million people whereas countries such as india, pakistan and bangladesh have only beds per million people. the situation is worse in sub-saharan africa where zambia has . icu beds per million, gambia has . and uganda has . beds per million. so the fatality rate in these countries is estimated to be much higher in these countries than wealthier nations [ ] . during a pandemic, standard crises care protocols should be developed by public health institutions to establish a systematic and evidence based procedure which ensures fair distribution of health care resources. thus shifting the focus from prioritizing individual patient benefits to maximizing benefits to the community as a whole [ ] . priority decisions regarding resource allocation should not be discriminatory i.e. based on sex, race, religion, disability, wealth, citizenship, social status or connections [ ] . moreover, the ethical debate regarding allocation of resources in lmics must take into consideration a wider context where critical care resources may already be scarce or non-existent even in a normal situation as compared to developed countries. in such conditions, ethical justification encompasses social justice governed with locally adapted global approaches [ ] . ethical standards support the idea that state is responsible for compensating the public losses incurred upon them due to public health interventions such as the containment measures including social distancing, quarantine and isolation. this is particularly important for people residing in resource constrained regions. the state ought to make social policies with the aim to share some of their burdens and costs e.g. by protecting the employment rights of citizens [ ] , providing financial support to the poor and needy such as daily wagers who might suffer due to shutting down of several industries as a result of lock down orders. however, lack of resources could seriously defeat this argument of compensation in these countries which cannot even provide for the basic health care needs of the people [ ] . in pakistan, it was estimated that between . million to . million workers in various industries were at risk of losing their jobs. according to human rights watch, the government must tend to the poorer workers who might be further pushed into poverty and it may dissuade them from voluntary quarantine necessary to contain the spread of the virus [ ] . a multi-lateral response by international community has been previously seen against similar threats posed in by severe acute respiratory syndrome (sars), in by swine flu (h n ), in by middle east respiratory syndrome (mers) and in - by ebola. all these crises were contained well via multilateralism and current crises of covid- is yet to be further materialized by this strategy. the current covid- crisis presents challenges that are beyond and above the earlier outbreaks, hence it deserves a well-established multilateral response. any pandemic requires the weak links to be strengthened on individual basis i.e. at the hospital level as well as community basis, country basis and even globally. therefore, it is the urgent need to shore up the health care systems in order to handle the current flood of cases as well as the future waves of the same or other related viruses. efforts for developing and supplying medical devices, diagnostic tools, vaccines, therapeutics, and other medical technologies for covid- pandemic can be seen globally. even though medical and scientific urgency are building, the medical technologies need to be tested efficiently, ethically and urgently with equitable availability to everyone around the globe. therefore, a multi-lateral response strategy which can accelerate scientific discovery and technology development with ensured safety, efficacy and quality is essential. further, there is need to coordinate the world health organization (who) for operational implementations. technology pooling and benefit sharing as previously witnessed during influenza [ ] and sars epidemic [ ] will not only save lives of millions of individuals by response acceleration to pandemics but will also encourage powerful administration of the global solidarity for the future epidemics. to protect people against deadly infectious disease outbreaks, it is critical that scientists and governments rapidly share information about the pathogens that cause them. the genetic information of sars-cov- was shared immediately and openly [ ] that accelerated the initial stages of diagnostic tests development and novel therapeutic compounds exploration. likewise, many researchers immediately shared their research information via open source publication [ ] . scientist from different countries are sharing medical course and epidemiological data and collaborating for medical guidelines development in response to the current pandemic [ ] . such examples of sharing information and open science need be incorporated throughout research and development of covid- medical technologies. moreover, the scientific community need to share every progress, every success and even the negative data so the research can be continued with uppermost speed to obtain the best results. some of the current and early research by pharmaceuticals, universities and medical device companies are funded by charities and governments. it is therefore imperative that such funding agreements mandate full data sharing, open source publishing and open collaboration following ethical guidelines regarding identity of subjects. a data-sharing system needs to allow collaboration between stakeholders in the absence of pre-existing relationships and all collaborators must adhere to fundamental ethical principles of data use. above all, it must ensure that people in all affected countries benefit from timely access to evidence-based interventions in emergencies. the multi-lateral response needs to be opened to the wide range of intellectual property rights, technology blueprints, technology specification, copyrights, patent rights, cell lines, research and regulation rights, data rights and clinical trial rights. in simple words, no exclusive right has to stand in the way of response to covid- pandemic by global research community in order to prioritize public health. similarly, all the rights such as confidential business information rights and trade secret rights required for bio similars, vaccine development and medical technology need to be accumulated and distributed hence to accelerate access to the market. it is therefore important to enable fast track registration along with emergency access to new medical technologies and medicines around the globe. some of the regulatory barriers can be eliminated by access to regulatory data and fast-track registration, however, countries should ensure that producers can bring medical technologies quickly into the market with equitable access. competition between producers has always resulted in increased supply with lower prices. in response to current pandemic, facilitating competitive supply source can present more advantages. as coronavirus infection is exponentially increasing with life threating outcomes, there is need of utilizing every possible option to mobilize supply capacity with respect to diagnostics tests, therapeutics, protective equipment, vaccines and other medical devices as soon as possible. with expanding supply, necessary actions should be taken to limit the export of needed ingredients, medical technologies and hoarding of medical supply to other countries [ , ] . compulsory licensing is a useful tool to be used during public health emergencies such as the covid- crisis when a treatment becomes available. international organizations and pharmaceutical companies should encourage the developing countries to pursue this option in the time of a pandemic [ ] . it would be difficult to minimize the socio economic impacts of covid- in due time. it is the prime responsibility of the international community to take public health measures in best interest of the public with providing access to basic health care facilities, information and resources without discrimination, embodying the values of respectfulness and cultural appropriateness. in the long run, governments in developing countries should strive to achieve self-sufficiency through policy interventions by mobilizing local industries to manufacture medical care resources such as personal protective equipment, ventilators for capacity building and facilitate the propagation of scientific research and technological innovations. once a vaccine is made available, it will be important to increase collaboration across the regions to ensure that the world's poorest countries have an equal access to adequate vaccine supply. through anthropogenic activities animal species are constantly under a severe threat of extinction amplified by the loss of biodiversity, global warming and animal trade. global communities must unite for the climate action if we are to prevent any further global scale pandemics. from sars to covid- : a previously unknown sars-cov- virus of pandemic potential infecting humans-call for a one health approach who. coronavirus disease (covid- ) situation report - edition: world health 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affairs the ethics of creating a resource allocation strategy during the covid- pandemic allocation of scarce resources in africa during covid- : utility and justice for the bottom of the pyramid. developing world bioethics a general approach to compensation for losses incurred due to public health interventions in the infectious disease context pakistan: workers face health, economic risks the race to patent the sars virus: the trips agreement and access to essential medicines pandemic influenza preparedness framework whole genome of novel coronavirus, -ncov, sequenced. science daily data sharing for novel coronavirus (covid- ) who launches global megatrial of the four most promising coronavirus treatment germany confirms that trump tried to buy firm working on coronavirus vaccine eu limits on medical gear exports put poor countries and europeans at risk. peterson institute for international economics the case for compulsory licensing during covid- publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we are thankful to the fellows of qau for providing valuable inputs. we are also thankful to ms. xanthine muller, from the radiobiology department of ithemba labs, cape town, south africa, for checking the manuscript for consistency and english language corrections. all authors contributed equally. the author(s) read and approved the final manuscript. this work is not funded. available on request.ethics approval and consent to participate not required. all authors agreed on publishing. authors declare no conflict of interest. key: cord- - lry wkn authors: aamir, alifiya; awan, sana; de filippis, renato; diwan, mufaddal najmuddin; ullah, irfan title: effect of covid- on mental health rehabilitation centers date: - - journal: j psychosoc rehabil ment health doi: . /s - - - sha: doc_id: cord_uid: lry wkn the sars‐cov‐ outbreak is an unprecedented event in modern history worldwide. to facilitate speedy and smooth recovery during this time period, an added responsibility is placed upon rehabilitation center counselors, staff and management. in this paper we expose the role that psychiatric rehabilitation plays during the covid- crisis. since covid- pandemic has remarkably raised mental health concerns, one of the high risks and possibly neglected groups includes individuals undergoing mental health rehabilitation, the impact on which can be significant as compared to the rest of the population. in order to ensure that individuals on the road to recovery are not alone and forgotten during the times of coronavirus crisis they should be provided with adequate resources, such as online meetings and group therapy sessions, assessment, treatment and support by telephone and video consultation and getting the medications they need to recover. this article highlights how the coronavirus pandemic, that has hit hard the health care and all categories of patients affected by mental disorders, is likely to be particularly dramatic for mental health rehabilitation centers. indeed, the covid- crisis has severely tested the health systems worldwide, reducing sometimes the quality and quantity of care offered to psychiatric patients both hospitalized and not in rehabilitation centers. the main goal of this paper is to raise awareness of the importance, often underestimated, of mental health rehabilitation centers, on which one should invest for the both future of psychological and psychiatric rehabilitation and the current crisis as well. severe acute respiratory syndrome coronavirus (sars-cov- ) responsible for coronavirus disease , which began as a few cases of a flu like disease in wuhan, china, is now a pandemic that has affected millions of people globally and has forced upon unprecedented changes in every field of life [ ] . during these times of crisis, inevitably people are expected to develop fear of the unknown and resist change, the magnitude of which has brought about population-wide psychological impact. due to the ongoing pandemic, individuals are most likely to develop feelings of anxiety and uncertainty due to fear of contracting the virus, whereas with all the changes and adjustments to daily routines, it has also brought on financial pressures, social isolation and unhealthy habits, therefore the impact of which on individuals undergoing rehabilitation is likely to be significant [ ] . during a previous influenza a h n v outbreak in the uk in , around % to % of the general public were very or fairly worried about the possibility of contracting the virus [ ] . consequently, there has been a striking increase in cases of depression, anxiety, and substance abuse [ ] . indeed, recent researches suggest that addiction problems are likely to worsen during the lockdown instead of slowing down [ ] . importantly, the covid- affected patients particularly those in isolation are likely to express stress, anxiety and depressive symptoms. such behavior has previously been reported from sars and mers cases, which found that many of those patients experienced some degree of confusion ( . %, of patients), depressed mood ( . %, of ), anxiety ( . %, of ), impaired memory ( . %, of ), and insomnia ( . %, of ) [ ] . in a meta-analysis, the point prevalence in the post-illness stage of these cases was found to be . % ( % ci . - . %) for post-traumatic stress disorder (ptsd), . % ( . - . %) for depression, and . % ( . - . %) for anxiety [ ] . since covid- pandemic has remarkably raised mental health concerns, one of the high risks and possibly neglected groups includes individuals undergoing mental health rehabilitation, the impact on which can be significant as compared to the rest of the population. this can be due to pre-existing depression and anxiety disorders in such individuals that can exacerbate in the times of crisis and shake the foundations of stability or recovery for them. to facilitate speedy and smooth recovery of such individuals during this time period, an added responsibility is placed upon rehabilitation center counselors, staff and management [ ] . as social distancing is considered to be the key preventive measure for infection control, mental health rehabilitation day boarding and day care centers, being a non-emergency service have limited new admissions, cancelled programs and have been temporarily closed at some places which in turn is going to significantly deprive people with chronic mental illnesses and intellectual disabilities of these services [ ] . the clinical outcome for these individuals will be adverse with a risk of aggravation of symptoms and even a relapse. therefore, it is imperative to develop home-based rehabilitation strategies such as telepsychiatry in order to continue therapy for them [ ] . individuals with pre-existing mental health problems are generally at high risk of infections, hence they are inevitably at an increased risk of covid- [ ] . some of them are of older age and on medications, and being identified as a vulnerable group can contribute to heightened anxiety [ ] . for patients with psychiatric disorders, it is expected of them to exhibit irrational behavior as many have been reported to show increased stress about their physical health, anger, impulsivity, and suicidal ideation [ ] . it may be difficult for people with schizophrenia and other related disorders to practice and adhere to the protective measures recommended to prevent infection such as hand washing, wearing masks [ ] . of note, it is a major challenge for individuals in rehabilitation to practice social distancing, as social interaction for them is not a luxury, but rather a form of therapy [ ] . group interactions and projects are part of their treatment where they walk the grounds, dine in communal areas, watch television together in day rooms, exercise and go to therapy together. the peersupport groups meetings and activities are such a vital source of emotional and spiritual support to people struggling to stay in recovery. hence isolation can be dangerous and the fear of contracting a life-threatening illness is unlikely to promote psychiatric healing. the psychology of fear associated with this virus can result in elevated levels of anxiety and depression which may have a negative impact on recovery [ ] . one of the major challenges faced by many individuals with underlying mental disorders and in recovery is prolonged isolation, which is likely to cause anxiety and depression that can be damaging if they are required to stay at home until the pandemic lasts. isolation is considered as a negative notion when it comes to mental health rehabilitation, hence forcing people to isolate will likely have adverse effects on recovery [ ] . in the fight against covid- pandemic, there is a need to address mental health challenges and develop strategies and interventions to ensure continued quality care. adequate measures are being taken in some countries like the usa, such as regular testing of patients and potential patients for covid- , adapting their programs to comply with social-distancing guidelines such as the use of telepsychiatry to limit the exposure possibility [ ] . there is a shift observed from on-site facilities and group therapies to virtual or phone conferencing platforms. these strategies will be effective to mitigate spread of covid- in vulnerable communities and simultaneously provide adequate care to mental health rehab patients. one emerging consequence of covid- is the presence of post-intensive care syndrome (pics) characterized by symptoms involving physical strength deficits, cognitive decline, and mental health disturbances observed after discharge from critical care that persist for a protracted amount of time [ ] . therefore, patients surviving intensive care units (icu) and mechanical ventilation for several weeks and other severe conditions will require early rehabilitation and other interventions. it is imperative to establish an integrated rehabilitation response for patients recovering from critical care at hospital with the help of psychologists, physical and occupational therapists etc. this issue needs additional attention in low resource countries where resources and workforce required for rehabilitation are inadequate [ ] . in order to ensure that all individuals on the road to recovery and/or admitted to a rehabilitation center are not alone and forgotten during the times of coronavirus crisis they should be provided with adequate resources, such as online meetings and group therapy sessions, assessment, treatment and support by telephone and video consultation and getting the medications they need to recover. author contributions all authors contributed to the article and approved the submitted version.funding no funding was provided for this work. conflict of interest authors declare no competing interests. covid- : the outbreak caused by a new 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communities date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: khjo j u the age-friendly cities and communities guide was released by the world health organization over a decade ago with the aim of creating environments that support healthy ageing. the comprehensive framework includes the domains of outdoor spaces and buildings, transportation, housing, social participation, respect and inclusion, civic participation and employment, communication and information, and community and health services. a major critique of the age-friendly community movement has argued for a more clearly defined scope of actions, the need to measure or quantify results and increase the connections to policy and funding levers. this paper provides a quantifiable spatial indicators framework to assess local lived environments according to each age-friendly cities and communities (afc) domain. the selection of these afc spatial indicators can be applied within local neighbourhoods, census tracts, suburbs, municipalities, or cities with minimal resource requirements other than applied spatial analysis, which addresses past critiques of the age-friendly community movement. the framework has great potential for applications within local, national, and international policy and planning contexts in the future. research has long recognized that environmental factors play a significant role in determining health and wellbeing in older age [ ] , and there are rising proportions of older people in the populations across the world. consequently, the recently released united nations decade of healthy ageing - calls for sustained global action to generate transformative change in four priority areas: addressing ageism; creating age-friendly communities; delivering integrated and person centered care; and providing long-term care [ , ] . increased urbanization and policy discourses supporting ageing in place add to the urgency to create and plan for age-friendly environments. on a global scale, life expectancy has increased from years in the mid- th century to an expected years by the mid- st century [ ] and % of the world's population is predicted to be aged over years by [ ] . the world health organization (who) world report on ageing and health [ ] documented how age-friendly environments play a which often includes transportation systems, land development patterns, and microscale urban design (e.g., footpaths) [ , ] . a lived environment reflects the importance of locality and access to good urban design, as well as human-made and natural environments to support health and wellbeing in the local neighbourhoods where people live. this is consistent with the argument regarding the narrow application of the term "built environment" where both human made and natural worlds are conceived as though there is no separation between them [ ] . spatial indicators provide a quantitative measurement of local lived environments using geocoded data (defined by x and y co-ordinates) developed using geographic information systems (gis). data linked to a street address can be mapped using gis and calculated as spatial indicators, providing aggregated measures across a range of geographic areas, including neighbourhoods or census tracts, suburbs, municipalities, regions, or states. aggregated geocoded data can be drawn from a range of existing administrative data sources that assess the lived environment and a range of social, economic, and environmental issues. spatial afc indicators consequently provide objective and cost-effective assessments of age-friendliness that are easily replicated across large geographic areas using desktop spatial analysis. these indicators can also be made readily accessible to local governments using online digital planning portals and liveability indicator systems for cities, like the australian urban observatory (auo.org.au) [ ] . the development of quantifiable spatial indicators of afc addresses the major critiques of the afc initiative-that it is too descriptive in approach [ ] , not measured or monitored by indicators [ ] , and without a clear understanding of an indicator framework [ ] . this paper proposes spatial indicator tools that can be applied for the assessment of afc in local lived environments using a gis methodology. these afc spatial indicators can also be applied in a variety of international contexts with direct relevance to the healthy cities movement [ ] , the new urban agenda, and the agenda for sustainable development [ ] . the agenda provides a global framework for sustainable urban development up until signed by all members states with specific targets. these include sustainable development goals (sdgs) with specific mention of older people in targets for goal reduced inequalities, goal sustainable cities and communities, and goal partnerships for the goals. in addition, the decade of healthy ageing [ ] calls for disaggregated data in twenty-eight indicators across eleven goals. spatial indicators measuring afc in lived environments are noted by the united nations as being necessary for the measurement and monitoring of any actions contributing to sustainable development (goal ) and multi-stakeholder partnership development and policy and institutional coherence. they have been developed to address segregation or siloed approaches in the current planning approaches and to encourage discussion and action that can promote integrated policy, planning, and practice across urban planning and public health. often the outcome of afc remains the sole responsibility of health or social planning with little integration across important portfolios, such as transport or statutory or strategic planning. the implementation of afc principles must extend beyond practitioners with interest in ageing and should ideally be integrated across policy portfolios with budget and legislative support. this paper aims to introduce a new set of afc spatial indicators that can be used to quantify and assess the age-friendliness of local lived environments and monitor changes in age-friendliness over time consistent with the sdgs and agenda. these indicators seek to support the decade of healthy ageing, which includes a commitment to action in the development of age-friendly environments and improved measurement, monitoring, and research [ ] as well as tools to support planners and practitioners working within government settings. these spatial indicators of afc also identify the importance of older people and their lived environments in sustainable urban development and the agenda. eight interconnected domains are included in afc ( figure ). the selection of specific spatial indicators to assess the lived environment of each afc domain was made following a workshop held with all five authors to identify the most relevant measures for each of these domains. the multidisciplinary experience of the research team spans gerontology, public health, urban planning, psychology, epidemiology, sociology, health geography, health policy, governance, and community development. with all five authors to identify the most relevant measures for each of these domains. the multidisciplinary experience of the research team spans gerontology, public health, urban planning, psychology, epidemiology, sociology, health geography, health policy, governance, and community development. potential indicators were then judged against the key criteria recommended by the who (box ) as well as other best practice principles for indicator application [ ] including: direct links to policy; connection to theory and existing research; available time series data; connection to budgeting and planning; relevance to most people; and connection to lived reality. these latter criteria being understood and relevant to most people, particularly older people, are particularly important and informed by previous research in the development of a specific indicator of access to services for older people [ ] , which included focus groups of older people to determine the local needs and services of highest importance. the selected measures also needed to be relevant to the majority of older people living in a wide range of lived environments, and to measure the most critical requirements for places that support afc principles. box . the criteria suggested for defining local afc indicators [ ] . will variations in the indicator be observable over time due to specific actions? disaggregation possible: can the indicator be disaggregated by gender, age group, or across neighbourhoods? there are also other strategies that could be important in the local context, including ethnicity, socioeconomic status, etc. aligns with local goals and targets: does the indicator link to a broader local agenda? can be linked to action: does the indicator provide an understanding of the various actions that might need to be undertaken? within local influence: does the local government or community have the mandate or authority to act on this indicator? for example, a federal insurance scheme is mostly beyond the influence of the municipal government. easy to collect: are the data required to produce the indicator easy to collect in a timely manner? socially acceptable: is the collection of this information acceptable to the communities and individuals concerned? the following section describes each of the selected afc spatial indicators with research evidence provided to support each indicator (table ). potential indicators were then judged against the key criteria recommended by the who (box ) as well as other best practice principles for indicator application [ ] including: direct links to policy; connection to theory and existing research; available time series data; connection to budgeting and planning; relevance to most people; and connection to lived reality. these latter criteria being understood and relevant to most people, particularly older people, are particularly important and informed by previous research in the development of a specific indicator of access to services for older people [ ] , which included focus groups of older people to determine the local needs and services of highest importance. the selected measures also needed to be relevant to the majority of older people living in a wide range of lived environments, and to measure the most critical requirements for places that support afc principles. box . the criteria suggested for defining local afc indicators [ ] . will variations in the indicator be observable over time due to specific actions? disaggregation possible: can the indicator be disaggregated by gender, age group, or across neighbourhoods? there are also other strategies that could be important in the local context, including ethnicity, socioeconomic status, etc. aligns with local goals and targets: does the indicator link to a broader local agenda? can be linked to action: does the indicator provide an understanding of the various actions that might need to be undertaken? within local influence: does the local government or community have the mandate or authority to act on this indicator? for example, a federal insurance scheme is mostly beyond the influence of the municipal government. easy to collect: are the data required to produce the indicator easy to collect in a timely manner? socially acceptable: is the collection of this information acceptable to the communities and individuals concerned? the following section describes each of the selected afc spatial indicators with research evidence provided to support each indicator (table ) . additional contextual factors for consideration include: the estimated resident population; proportion of population aged more than years; population age distribution including proportions of older and younger populations in area; ethnicity; education; homeownership; residential density; remoteness e.g., accessibility/remoteness indices or the distance between towns in rural settings; the risk of natural disasters; climatic conditions; and the impact of climate change. * recommended as priority indicators for inclusion. the suggested spatial indicators for each afc domain are presented in table with the priority indicators notated with asterisks. this provides flexibility for practitioners in identifying the key spatial indicators of importance to afc or additional optional indicators where resources are available. additional information is provided below explaining why these indicators are recommended for each afc domain with detailed explanations of the supporting research evidence. the indicators recommended in the following section were identified in accordance with indicators acting as icebergs and highlighting issues of major importance [ ] . only after the major factors have been quantitively assessed should further qualitative assessment be completed, similar to a hierarchy of need. for example, if there are no public open spaces available there is little point in assessing the maintenance, shelter, or facilities available in public open spaces within an area. additional qualitative assessment could also include local consultation with older residents and relevant stakeholders. the priority indicators identified for this domain are walkability for transport [ , ] and access to public open space within m [ ] . these indicators are directly related to walking [ ] [ ] [ ] , specifically in older people [ ] , and associated with physical health benefits [ ] and mental health benefits [ ] . walkable neighbourhoods are important for older people because, along with the fact that they enable people to reach destinations with commercial and social opportunities [ , ] , walking is also associated with maintaining functional independence [ ] and better cognitive function [ ] . similarly, public open spaces that are easy to visit with walkable access are important for older people and important in reducing social isolation and increasing physical activity [ ] . data required to create indicators of walkability are commonly available within municipal and planning contexts. road network analysis (a way to walk), land use mix (destinations to walk to), and housing density (people to service the destinations) are common key components of walkability assessments. similarly, public open space location data are also regularly held by most municipal governments. footpaths are an important infrastructure supporting walking in older people [ , ] , and walkability can also be refined by superimposing footpath access where spatial data are available. an example of a walkability for transport assessment for the regional city of launceston in tasmania, australia was calculated and is provided in figure to demonstrate the value of neighbourhood level walkability assessments. the results clearly suggest that the inner neighbourhoods of the city of launceston have good walkability while the outer neighbourhoods are less supportive of walking for transport, particularly those on the eastern side of town. additional spatial indicators for consideration include intersections with visual and auditory signalled pedestrian crossings that allow time for older people to cross over roads, and particularly busy intersections [ , ] . in australia, many regional towns avoid the use of signalized pedestrian crossings and opt for roundabout intersections, which encourage continual traffic flow and can be frightening for people with reduced mobility. access to public seating is also recommended to be available within local public open spaces to encourage rest stops while walking (overlapping with the suggested measure of accessibility to public open space). clean and safe public toilets are also recommended, including those with accessibility features [ ] and should also be included within high quality public open spaces. accessible buildings are italicised in table due to the difficulty in sourcing data that measure buildings developed according to universal design principles. if possible, these are recommended, as older people experience difficulties associated with access to public buildings and the lack of handrails, narrow corridors, and steps [ ] . post occupancy evaluations are generally more common in sustainability assessments [ ] and are time and staff resource intensive but could be considered as an alternative measure if no other data are available to assess buildings. additional spatial indicators for consideration include intersections with visual and auditory signalled pedestrian crossings that allow time for older people to cross over roads, and particularly busy intersections [ , ] . in australia, many regional towns avoid the use of signalized pedestrian crossings and opt for roundabout intersections, which encourage continual traffic flow and can be frightening for people with reduced mobility. access to public seating is also recommended to be available within local public open spaces to encourage rest stops while walking (overlapping with the suggested measure of accessibility to public open space). clean and safe public toilets are also recommended, including those with accessibility features [ ] and should also be included within high quality public open spaces. accessible buildings are italicised in table due to the difficulty in sourcing data that measure buildings developed according to universal design principles. if possible, these are recommended, as older people experience difficulties associated with access to public buildings and the lack of handrails, narrow corridors, and steps [ ] . post occupancy evaluations are generally more common in sustainability assessments [ ] and are time and staff resource intensive but could be considered as an alternative measure if no other data are available to assess buildings. there is a growing body of evidence showing a positive association between healthy ageing and blue space [ ] . this is worthy of future consideration but is not accessible within all lived environments and, hence, has not been included as a recommended measure within the outdoor space and building domain but could be considered as second tier measures. blue space is defined as outdoor environments (natural or manmade) that prominently feature water and are accessible proximally (being located in, on, or near water) or distally/virtually (being able to see, hear, or sense water) [ ] . therapeutic design of a built environment using urban green and blue infrastructure was shown to be protective for healthy ageing while supporting those with cognitive decline, or illness [ ] . similarly, a study of largely older people in hong kong found that general health was significantly higher in people with a sea view from their home [ ] , while, in ireland, older people had a lower risk of depression in those with more sea views [ ] . in addition, nature-based solutions, there is a growing body of evidence showing a positive association between healthy ageing and blue space [ ] . this is worthy of future consideration but is not accessible within all lived environments and, hence, has not been included as a recommended measure within the outdoor space and building domain but could be considered as second tier measures. blue space is defined as outdoor environments (natural or manmade) that prominently feature water and are accessible proximally (being located in, on, or near water) or distally/virtually (being able to see, hear, or sense water) [ ] . therapeutic design of a built environment using urban green and blue infrastructure was shown to be protective for healthy ageing while supporting those with cognitive decline, or illness [ ] . similarly, a study of largely older people in hong kong found that general health was significantly higher in people with a sea view from their home [ ] , while, in ireland, older people had a lower risk of depression in those with more sea views [ ] . in addition, nature-based solutions, through green and blue space urban management planning, can mitigate the health impacts of climate change while addressing the need for climate resilience in local communities [ ] . future revisions of the afc principles could consider the inclusion of more detailed measures of green and blue spaces in the domain of outdoor spaces and buildings to address changing climates around the globe. these could include access to local blue spaces, public and private tree canopy coverage, public street tree canopy coverage and the associated shade capability, in combination with the currently recommended measures of walkability and accessibility to public open space. these measures are very worthy of consideration but bring their own challenges in terms of data access and spatial capability making them harder to produce. consequently, they are suggested as potential expanded, not essential, measures of the afc lived environment assessment. transport is an important determinant of health [ , ] influencing access to local services, engagement in paid and non-paid productive activities (such as employment or volunteering), maintaining and developing social networks and supports, and engaging in social and recreational activities. public transport has also been identified as a critical influence of liveability in a community [ ] and active transport important to older people [ ] . policy-relevant spatial public transport indicators are typically based on m access or a -min walk [ , ] . another important factor that influences the use of public transport is service frequency. consequently, access to any public transport stop provides a high-level assessment while access to frequent public transport provides a more refined assessment. similar measures are also included in the australian government's national cities performance framework (https://www.bitre.gov.au/national-cities-performance-framework). for older people, mobility is essential for social participation and wellbeing [ ] . public transport is particularly important for older people who might have a reduced ability to drive. older people tend to use public transport more frequently if there is easy access to public transport in neighbourhoods at a distance less than min away [ ] . this is also consistent with existing research that found that the frequency of public transport and wait time affected older people's willingness to travel [ ] and that a high proportion of older people are no longer driving [ ] . data for these indicators can most often be sourced from public access data portals, open street map or general transit feed specification (gtfs) where public transport data are provided by transport agencies into a computer readable format for web developers [ ] . gaining access to more detailed data describing public transport that meets disability standards is another very valid indicator and has been associated with increased satisfaction and perceived useability in older people [ ] . similarly, access to a bus stop with an accompanying shelter and seat is also important for older people's mobility, as well as dropped curves, footpaths, and pedestrian signals [ ] . housing is central to living a productive, meaningful, and healthy life, and housing quality is an important influence on self-reported health [ ] . unaffordable housing is detrimental to mental health in low to moderate income households [ ] . unaffordable housing has also been associated with an increased risk of poor self-rated health, hypertension, and arthritis, and renting, rather than owing a home, increases associations between unaffordable housing and self-rated health [ ] . consequently, housing costs and gentrification [ ] are particularly important to consider, with housing stress in lower income households being a particularly important indicator for the assessment of age-friendly cities. housing needs, sizes, and types can change as people age. older people might consider downsizing to smaller homes with reduced maintenance needs or to be closer to extended family for support to age in place [ ] . in rural and regional areas, older people might need to move from larger farms and back into towns where services are more readily available. alternatively, frail older residents might require the support of aged care providers to support high care needs. addressing these issues means that communities need to understand the available housing diversity options (e.g., larger houses, smaller houses, units, and apartments to serve broad community needs) as well as access to services for residents. afc supports multiple housing options that are beneficial to all residents with many municipalities thinking primarily about formal aged-care accommodation when addressing housing needs for older people. even more concerning in australia, it is common for aged care facilities to be built on the outskirts of cities and towns where there is an abundance of inexpensive and undeveloped land. this isolates older people from the rest of the community, makes it harder for people to access and visit, decreases access to other community services, and decreases intergenerational contact within communities. the / housing affordability indicator is recommended and describes the proportion of households in the bottom % of household incomes spending more than % of their income on housing costs [ ] . this measure is also referred to as the ontario measure where the interest in housing affordability first identified the disproportionate impact of housing costs on lower income households [ , ] . understanding community demographic profiles, particularly age, in combination with the high incidence of / housing affordability issues should raise concerns for any community wanting to support age-friendliness. specifically, older adults on an aged pension within the private rental market will face significant challenges in housing affordability [ ] . the indicator of access to services for older people was developed with older people themselves [ ] and includes hospitals, general practitioners, aged care facilities, public transport stops, supermarkets, community centres, libraries, and universities of the rd age, and could also include places of worship and parks. this indicator also provides a useful assessment for the afc domain of community support and health services but is included in the housing domain to reinforce the importance of urban planning that supports the co-locations of services and housing options. the proportion of government owned dwellings could also be investigated as an additional support measure of afc, particularly in lower income areas. meaningful social relationships and participation are essential for good health, with health defined as a social phenomenon in the social determinants of health [ ] . social participation has been associated with physical activity [ ] , mental health [ ] , reduced psychological distress [ ] , reduced risk of myocardial infarction [ ] , and up to a % increased likelihood of survival in people with strong social relationships compared to lifestyle risk factors [ ] . for older people, social participation provides greater life satisfaction [ ] , is protective against cognitive decline [ ] , and contributes to resilience in older people [ ] , especially in rural communities [ ] . social participation is also being taken seriously internationally, and the united kingdom appointed a new minister for loneliness and a national government action plan on loneliness [ ] . the recommended spatial indicators supporting social participation connect to the access to services for older people [ ] that are included in the housing domain. two indicators are recommended: access to community centres and neighbourhood houses; and access to recreational services that cater to the needs of older people. shared or 'third spaces' such as these are critical social infrastructure [ ] and essential in supporting social participation for older adults [ ] . recreational services also support physical and mental health through opportunities for physical activity designed for older people and supporting community connections. another indicator recommended for inclusion is access to a local library, which also supports the afc domains of respect and social isolation, communications and information, and community support and health services. libraries provide multiple community benefits beyond simply lending books [ , ] , including multimedia borrowing, technology training, community classes, lectures, and opportunities for intergenerational and community connections. libraries also support the need for learning opportunities across the course of life with universities of the third age (u as) providing social and learning benefits to older people [ , ] . this is associated with better physical health and activity levels [ ] . places of worship are also considered an important facilitator of social connections and social capital [ ] , particularly in humanitarian arrivals [ ] and different cultures [ , ] . respect and social inclusion are essential to ensure social participation for older people. there is much debate on the definition of social inclusion, though most studies refer to an objective participation in society and a more subjective assessment of whether the actual participation meets an individual's preferences [ ] . most definitions of social exclusion emphasise the importance of social activities as a core component [ ] . however, the effects of cumulative disadvantage, decreasing social networks, and age discrimination magnify the negative health and wellbeing impacts of social exclusion in later life [ ] . a local or lived environment must provide accessible buildings, housing and transport, along with opportunities for social activities to occur if social inclusion and social participation are supported and encouraged. previous research on the services deemed important for older people has emphasised the importance of local services, such as shops [ , ] , and this is supported by the use of new spatial indicators that can access formal and informal places to meet. these include recommended indicators of access to social clubs/senior citizens clubs or participation in international clubs, like rotary or probus, that are more formally organised by older people themselves. alternatively, informal opportunities for social inclusion include an indicator of distance-based access to local cafes that support broader intergenerational social opportunities. older people need a range of venues to create opportunities for social activities as a foundation for community respect and social inclusion. empowerment, autonomy and control [ , ] , and employment conditions [ ] were all found to be important influences of actual and self-reported health. control over one's own destiny has also been proposed [ ] , consistent with an understanding of health being simultaneously influenced at the individual (micro/personal), place and community context (meso/community) as well as the larger societal context (macro/societal level) [ ] . civic participation and employment are important influences of agency and autonomy in a society. consequently, it is important to understand how many older people are engaged in paid and unpaid productive activity in the community. this is best measured through the proportion of people who remain employed past the official retirement age ( years in australia noting there is no official retirement age and eligibility for the aged pension is currently years increasing to years by ) or people aged years or more who are engaged in regular volunteering. these indicators of paid and unpaid productive activity are also important measures of social engagement and civic participation and could be separated into additional age brackets or deciles (e.g., - years) for more detailed information. it is important to note that employment is also not defined according to hours worked, acknowledging both the civic connections and benefits that come from any level of paid employment and that retirement is not a single event and includes a diverse range of retirement patterns [ ] . there has been criticism regarding the dominance of volunteering in measures of collective civic social participation in older people [ ] with voting participation argued as a better measure of civic participation [ ] . however, voting participation is less relevant in countries like australia where electoral voting is compulsory and volunteering activities are measured every years. volunteering is also particularly important in regional areas of australia where third sector or non-profit organisations rely on older people volunteering [ ] with increasing proportions of older people residing in rural locations [ ] . in countries where voting is not compulsory (e.g., the usa), then voting participation could be considered as an additional measure of civic engagement. in , approximately % of australian households had access to the internet [ ] . this proportion decreased to % in remote areas where it is common to have a high proportion of older people within populations, with entertainment, social networking, and banking the most commonly supported activities supported by internet connection. internet access is also becoming more necessary to access information about the government, health, banking, and community services as well as to maintain contact with friends and family. finding information on services like these is also critical for older people to age in place and is necessary to support independent living and the connection to communities [ ] . th information provision also extends beyond essential services and includes services provided by local libraries, which includes online books, audio, audio-visual, and educational resources that can be made available online for people with physical or geographical mobility restrictions. online streaming (e.g., netflix) is another more recent example of recreational activities supporting social connection and information provision. however, all these online resources require household internet access. access to a national radio service is another important source of information and becomes particularly important in emergency management, including preparation and recovery from natural disasters, such as floods, droughts, and bushfires, which are becoming increasingly more commonplace in australia. emergency sms messaging systems are also deployed during emergency situations to inform residents of impending safety risks but are worthless without adequate mobile phone reception. climate change is predicted to increase the likelihood of these emergency situations making telecommunications assessment essential in the support of afc. it is also necessary for developing technologies, including passive surveillance of movement monitoring within the home, personal alarm devices, and telehealth [ ] , which have become increasingly accessible and necessary during the coronaviruses (covid- ) pandemic. communication is an important influence on the wellbeing of older people [ ] , and both household internet and mobile phone reception provide essential telecommunication systems that support both intergenerational communication with family and friends, the communication of essential information [ ] , and the ongoing adoption of new technologies [ ] , as well as influence the quality of life [ ] . currently, there is a paucity of references or inclusion of technological solutions offered to support afc and healthy ageing and technology, and icts have recently been suggested as a new smart age-friendly ecosystem framework [ ] . suggestions included in this new framework to assist afc include: the development of smart housing; the inclusion of ageing in smart cities and engagement with the internet of things (iot); the better use of digital assistants (e.g., alexa) in the home; the use of digital robots for deliveries; electronic camera enabled doorbells; and motion sensors to detect mobility. technological features like these require inclusion during new housing development and have benefits across multiple afc domains beyond communication. they also require a rethink and interdisciplinary collaboration between planners, architects, developers, computer science, industry, and the government. while the opportunities are waiting for action, they also require engagement with older people themselves and their families using qualitative and ethnographic research methods [ ] . this is an important area of growth and future development in afc and requires further research. access to primary health support services is essential and necessary for people to age in place. it is also the preferred option for most older people to maximise their health and wellbeing [ ] . within the local community, access to general practitioners has been identified by older people themselves as essential community support services [ , , ] and the key access point for primary health care. consequently, access to general practitioners was identified as an indicator of primary importance within community support and health services. these practitioners also provide gateway services and referrals to any other medical specialists, including geriatricians, who specialise in treating conditions that affect older people, including dementia. additional indicators that should be included relate to housing support either as in-home support packages or residential aged-care accommodation. all of these services are also included within a complete definition of social infrastructure, which has an important influence on subjective wellbeing [ ] and are important components of liveability [ ] . the approaches and spatial measures described above were applied in a case study in a regional context and rural centre in north-eastern victoria, australia. the regional town is located over km north-east of the capital city of melbourne in the centre of the state of victoria, south-eastern australia. the major industries are agriculture and manufacturing, with a population of over people. both the state government department of health and the local municipality/council were interested in analysing and understanding afc and broader liveability given an increasingly ageing rural population. the spatial measures used to assess this included: walkability (with and without footpaths); access to public open space; access to public transport; housing affordability; housing diversity; government owned dwellings (social housing); access to services for older people; libraries; universities of the rd age; places of worship; volunteering; households with internet access; aged care facilities; and access to general practitioners. the results were presented to the local health department officials, the local municipality, and as a community presentation to residents at the local library. many of the challenges and barriers to afc planning were identified in the spatial measures and were confirmed by the lived experiences of residents from the local community. these included: poor walkability on the outer areas of town; difficulty getting to doctors and medical services located at the regional hospital located on the outer town boundary with limited public transport and poor walkability; disconnection between the older people, families, and younger people in the town due to the location of residential aged care on the town boundary next to the hospital; the importance of cafes and social spaces in the centre of town to support community and social connections; the value of the town's library, art facilities, and public open spaces; and inequity in the disadvantaged areas of the town that had reduced access to public transport and lower levels of household internet connections. the use of mapped spatial measures of afc was hugely beneficial for inter-agency conversations and planning initiatives as well as community conversations, engagement, and validation of the spatial analyses. the results also highlight the future negative impact of the age-friendliness of the town if future residential aged care development is supported in the outer areas of the town. the original who global age-friendly cities guide was developed in response to the rapid population ageing and urbanisation across the world and was informed by interviews conducted with older people themselves in over different countries [ , ] . the ultimate aim of afc is to create environments that support healthy ageing. this paper provided detailed, objective, and functional spatial measures of age-friendliness across lived environments that can be used to assess, monitor, evaluate, and communicate age-friendliness refined to the neighbourhood level. objective spatial measures of the lived environment are critical for the following reasons: to simplify assessments of afc; to provide a foundation level of knowledge about the age-friendliness of an environment; to assist local and state government planning by informing and monitoring future actions and interventions needed to promote healthy ageing in communities; and to include older people into targets of the sustainable development goals and the new urban agenda. the movement has previously been criticised for a lack of objective measurements and the need to connect these ideals into functional measures connected to policy, planning, and financial levers [ ] . previous attempts at developing indicators of age-friendliness have been non-specific, non-coordinated, and reliant on survey-based responses (e.g., world health organization [ ] ). such assessments are also beyond the budget, resources, capabilities, and motivation of local planning agencies and municipalities. the proposed spatial measures of age-friendliness across lived environments is relevant to planners, policymakers, advocacy organisations, governments, architects, industry, citizens and research audiences. the suggested indicators are provided to guide and inform discussions and interventions to promote healthy ageing. the measures can also be adopted and customised to local environments ranging in geographic and population sizes, rurality, climate conditions, and resource limitations. the proposed spatial indicators of afc address these issues through the application of gis technology to produce an objective assessment of the age-friendliness of local lived environments, drawing on indicators from the liveability literature that are specifically relevant to the values, preferences, and needs of older adults. these indicators provide measurement and quantification of afc domains consistent with the idea that value comes with measurement and leads to knowledge production as argued by lord kelvin over hundred years ago [ ] . the more simplistic interpretation of this, is that what is measured, is valued, and consequently is done. one of the critical issues raised in the recommended afc spatial indicators is the connection of all indicators within existing policy and planning contexts [ ] . all the recommended indicators can be linked to existing policy and planning environments regardless of whether these have a local/municipal, state, or national focus. the connection of indicators to policy has been long identified within social indicator research [ , ] . these indicators can assist governments in meeting their commitments to the sustainable development goals in a way that is meaningful for a growing segment of their populations. there is also an increasing interest and development in public health digital observatories. for example, relevant liveability indicators for the largest cities of australia are available in the australian urban observatory (auo.org.au) launched in . there is an opportunity to make spatial indicators available through novel data visualisation and ease of communication providing an influence on the policies required for healthy ageing across communities. the spatial indicators recommended for assessing afc domains can all be influenced and improved through policy levers. this includes the indicators suggested for outdoor spaces, transport, housing, social participation, respect and social inclusion, civic participation and employment, communications and information, community support, and health services. the indicator results can be influenced though local and immediate strategies or applied in advocacy with the responsible higher government agencies. this can include reviewing afc assessments within the context of current policy contexts, existing public health planning, liveability planning, transport planning, strategic planning, land use, and statutory planning it is also important to acknowledge the limitations of afc spatial indicators and understanding that these aggregated area-based results effectively act as icebergs of knowledge [ ] providing a tip of the iceberg assessment of what is occurring, with additional information required to understand why the result is happening and how it can be addressed. consequently, the objective afc spatial indicators should also be combined with additional sources of knowledge. these include consultation and engagement with local older people themselves to expand understanding, prioritise actions, and support the greatest social and economic benefits and returns on investments that support improved health and quality of life for older people. given the diversity of cities, communities, and places, it is recognised that the achievement of all suggested indicators might not be feasible across all geographic settings. this is particularly relevant to rural and regional locales, which often have a lower population density and reduced levels of physical or social infrastructure. consultations with older people and combining subjective understandings with more objective afc spatial indicators will also help to inform the understanding of unique community contexts, including regional and remote areas. for example, high levels of walkability might not be possible across an entire town in a rural area with a small population. alternatively, signaled pedestrian crossings might not be necessary. however, a walkability assessment using the recommended walkability indicator could identify walking and transport barriers (e.g., a major road or bridge across a rail line) or identify the best location for new community services. alternatively, the distances and measures of accessibility listed within indicators may vary across diverse rural and regional settings, but as noted above, these definitions of access within indicators must be determined through consultation with the older adults and communities to a reach consensus on what can be reasonably expected within this locale. consequently, in certain settings, these proposed indicators should act as a tool to prompt place-specific discussions around what is important in terms of measurement indicators, and what is achievable (particularly in relation to what should constitute reasonable access). a notable challenge of afc planning is the absence of the relevant climate change implications in the current afc principles and domains and inclusion of ict and new technology. we recommend that future revision of afc should expand and account for the challenges associated with climate change given the implications on the health and wellbeing of older people [ ] and the ultimate afc goal of healthy ageing. the relationship between older people's physical health and mental health with the environment, urban design, architecture, and afc could also be considered in the development of future indicators [ ] . understanding and expanding afc spatial indicators for unique contexts and environments is needed in the future and this current foundation of recommended indicators can be applied and tested across a range of different locations. this could include localities with climatic extremes (e.g., heat, cold, and snow), regional and rural locations, international comparisons, and cultural differences to explore how communities differ and what additional indicators should be included. the major aim of this research was to propose a foundational set of objective afc spatial indicators that can be applied in any location with minimal resources and are directly aligned for policy intervention. this is particularly relevant to planning and policymakers working in government and was neither previously available nor consistently applied within afc locations. further research should investigate how this proposed suite of afc spatial indicators can be added to, refined, or customized to address the needs of many different locations, 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of information technology, australia information provision for an age-friendly community ageing in place in the united kingdom interpersonal communication in older adulthood intergenerational effects on the impacts of technology use in later life: insights from an international, multi-site study connecting at local level: exploring opportunities for future design of technology to support social connections in age-friendly communities effects of technology use on ageing in place: the izi pilots who doesn't think about technology when designing urban environments for older people? primary health care and older people the ideal neighbourhood for ageing in place as perceived by frail and non-frail community-dwelling older people oxford essential quotations lessons learned from the history of social indicators; redefining progress disappointments and legacies of social indicators climate change in an ageing world. helpage international knowledge synthesis for environmental decisions: an evaluation of existing methods, and guidance for their selection, use and development: a report from the eklipse project the authors declare no conflict of interest. key: cord- -dojdlfrv authors: doerr, megan; wagner, jennifer k title: research ethics in a pandemic: considerations for the use of research infrastructure and resources for public health activities date: - - journal: j law biosci doi: . /jlb/lsaa sha: doc_id: cord_uid: dojdlfrv the number and size of existing research studies with massive databases and biosample repositories that could be leveraged for public health response against sars-cov- (or other infectious disease pathogens) are unparalleled in history. what risks are posed by coopting research infrastructure—not just data and samples but also participant recruitment and contact networks, communications, and coordination functions—for public health activities? the case of the seattle flu study highlights the general challenges associated with utilizing research infrastructure for public health response, including the legal and ethical considerations for research data use, the return of the results of public health activities relying upon research resources to unwitting research participants, and the possible impacts of public health reporting mandates on future research participation. while research, including public health research, is essential during a pandemic, careful consideration should be given to distinguishing and balancing the ethical mandates of public health activities against the existing ethical responsibilities of biomedical researchers. although public health research is undoubtedly essential during a pandemic, the line between research and public health activities is tricky in the best of times and can blur quickly in a public health emergency. elements common to both endeavors range from study design, to the collection and use of personally identifiable and protected health information, and to analysis techniques. many point to the a priori purpose of a given initiative as a way to distinguish between research and public health activities. yet, even while public health practice focuses on assurance, assessment, and policy development, these activities might contribute to generalizable knowledge-the hallmark of research. for example, in following the deepwater horizon oil spill in the gulf of mexico, the u.s. centers for disease control and prevention (cdc) tapped into the national poison data system (npds) for the purpose of monitoring health impacts of people in the region (ie, surveillance as a public health activity). nevertheless, the cdc's utilization of the npds post-environmental disaster also demonstrated the database's utility for advancing scientific understanding of how oil spill exposures affect human health (ie a resources for potential public health research with the primary purpose of contributing generalizable knowledge). additionally complicating the divide between research and public health activities is the now widespread practice of banking of data and samples for secondary research use. during a public health emergency, research repositories are attractive, ready-made data resources and communication channels with large, and, ideally, diverse cohorts through which public health activities could be pursued expeditiously. given that emergency responses 'tend to be nonresearch,' what risks are posed by repurposing research infrastructure for public health activities? the covid- pandemic has already provided case examples highlighting key questions about the public health activities that seek to leverage existing research infrastructure. for research participants and collected nasal swabs with the goal of improving detection, monitoring, and control of influenza outbreaks in greater seattle, washington. on march , , the new york times reported on sfs's ongoing efforts to assess retrospectively the prevalence of the novel coronavirus, sars-cov- , using nasal swab samples collected for research purposes during the - influenza season. in early february , sfs began petitioning the state, cdc, and u.s. food and drug administration (fda) officials for permission to use the sfs's existing sample bank to track covid- spread. sfs participants had consented to the testing of their swabs for influenza and 'other respiratory pathogens (germs)' and to receiving these research results back from the study team, as well as for the secondary use of their data for research purposes. through the consent process, sfs had alerted participants that washington state law requires reporting of infectious diseases, including influenza, but did not discuss the use of sfs's research infrastructure, including data or samples, for other public health activities. after about weeks of rebuff, and within the context of undeniable national spread of the virus and inadequate testing for it, the sfs team decided to test the samples without the explicit approval of public health authorities or regulators. the sfs team promptly identified a sars-cov- positive result and alerted local public health officials. the sample was rerun in the washington state laboratory, where the positive result was confirmed, and the research participant was subsequently notified by public health officials. despite this apparent successful use of existing research infrastructure for public health activities, cdc and fda regulators ordered sfs to stop retrospective testing of their existing samples immediately but indicated that, with additional consent language clarifying the use of research study materials for public health activities, sfs could prospectively test participants for sars-cov- . in the first few days of march, the university of washington's ethical review board determined that, given the public health emergency, sfs had an ethical obligation to test all samples for sars-cov- , citing that sfs already had consent from participants to test for another communicable diseases and return those results and, therefore, was already engaged in both research and public health activities. on march , , state regulators again shut down retrospective testing by sfs. sfs eventually completed its retrospective testing of samples, identifying positive results across participants, including the first documented case of community transmission of sars-cov- in the usa. the back and forth between federal and state authorities, the research team, and the overseeing ethics board, which eventually culminated in the seattle flu study turning its resources toward a joint public health initiative announced march , , illustrates the complexity of the boundary between federally regulated research and public health activities and highlights key concerns about the repurposing of research infrastructure and its use for public health activities. firstly, what are the points researchers must consider as they contemplate either mining already collected research data during a public health emergency, or, as in the case of the sfs, undertaking new analyses on already collected samples in the name of public health response? secondly, what are the considerations for reporting back to research participants types of information derived from public health activities not explicitly disclosed in the informed consent process? thirdly, given the uncertainty of risks and benefits posed by public health activities, are there any additional concerns raised by legal mandates to disclose information derived from research sources to public health authorities at different governmental levels? these questions are particularly worthy of contemplation given the number of large research initiatives' data and sample banks that could potentially be called upon by public health authorities during this pandemic-including, notably, the national institutes of health's all of us sm research program. most federally sponsored human subject research activities are governed by a set of regulations known as the common rule. however, while public health research is governed by the common rule, public health activities are among those deemed 'not to be research' and therefore entirely outside of common rule's reach. this regulatory exception specifically acknowledges that public health activities may 'use information and biospecimens from a variety of sources,' including, presumably, from existing research studies or data repositories. section . (d)( )(iii) further clarifies consent is not required for secondary use of research data or biospecimens for public health activities. so regardless of whether the data used for public health activities are data that have been previously generated for research or novel data generated from research samples, public health activities are legally considered 'not research.' following from this exemption, the use of research data/specimens for public health activities does not require consent from the individuals to whom those data and samples originated. from this perspective, the sfs would not have needed additional consent of participants for sars-cov- testing had the sfs's sars-cov- testing been designated a public health activity. arguments in favor of research data use for public health activities highlight the difference between the profound physical and emotional harms wrought by historical antecedents, such as the notorious u.s. public health service syphilis study at tuskegee, and the potential dignitary harms caused by data or samples previously derived from consented research participants being used for public health activities. and if the primary risk posed to research participants by public health activity use of their data is dignitary harm, researchers should correspondingly consider the privacy rights of participants (outside of those mutually agreed upon in informed consent) before proceeding with these activities. the most influential health data privacy protections in the u.s. are codified by the health insurance portability and accountability act (hipaa) privacy rule. all covered entities and their 'business associates' must follow the hipaa privacy requirements, which generally covers people/entities providing healthcare, health insurance, or related services. under hipaa, outside of their use for care delivery, anyone wanting access to a person's records must obtain their explicit consent with a few very specific exceptions. one of the exceptions that allows for no-signature release of protected personal health information is the request of a 'public health authority.' within the regulations 'public health authority' is broadly conceptualized as a federal, state, or other territorial division's agency or authority (or their designee), whose mandate includes public health matters. notably, the u.s. national institutes of health (nih), the largest funder of biomedical research in the world, is authorized by law to assist as a 'public health authority' based on u.s. department of health and human services (hhs) interpretation dating back to at least december . as a public health authority, one might argue that the entirety of the nih's research resources-whether nih-funded researchers or participants are aware or not-might be accessible for use in public health emergencies unless other restrictions would preclude such use. notably, the sfs, funded through the private brotman baty institute for precision medicine, under nih's public health authority designation and was not designated as a public health activity by state authorities as it initially pursued sars-cov- testing. of further interest with regard to privacy protections, during a pandemic, certificates of confidentiality-which are shields protecting identifiable sensitive research information from disclosure-are potentially penetrable, as disclosures are permitted if required by laws regarding the reporting of communicable diseases, necessary for the individuals' medical care, or done with the individuals' consent. although the human subjects research regulations are relatively clear-cut with respect to public health activities, the ethical considerations for the use of existing research infrastructure for public health activities might not be. past examples of unethical practice of public health research drove the development of the current regulatory structures intended to protect human research subjects. almost two decades ago, dr nancy kass set forth an ethical framework for public health practitioners to assess the implications of public health activities, distinguishing biomedical ethics (which relies heavily upon individual autonomy) and public health ethics (which emphasizes justice, among other principles). later lee, heilig, and white ( ) provided a compelling justification for the conduct of public health surveillance in the absence of explicit consent from individual patient-participants, recognizing an ethical obligation to put any public health data collected to use and, similarly, the need to justify nonuse of data that has been collected ['to use the data we collect for public health benefit; not using the data for improving health must be justified' (at )]. as felice batlan highlights in her analysis of national security claims from the lens of public health emergency, the power to define a 'public health emergency' and the ethical concerns raised by these powers are far from straightforward. these complexities are only compounded if individual researchers themselves-rather than designated public health authorities (such as the nih as a whole) who/which are, at least, politically accountable-take it upon themselves to engage in public health activities, as did the researchers of the sfs who quietly defied state and federal guidance to continue their testing program. when research resources have been funded by public tax dollars (such as nih grants), even decisions regarding the well-intentioned donation of supplies and equipment (redirecting such items from research labs that were wound down as nonessential during the pandemic to support emergency medical compromising individual rights and interests for public benefit has a fraught and contentious history. yet even the constitutionally protected right to privacy has long been recognized as not absolute but one that is (i) conditioned upon exercise of that individual right to privacy not interfering with another's enjoyment of the same right and (ii) subject to reasonable, proportional, and necessary constraints imposed by state and local authorities fulfilling their roles to ensure public health and safety and by federal authorities supplementing such public health responses when they are inadequate. moreover, there is a compelling argument that, although not yet widely recognized, there exists a constitutional right to public health. this argument builds upon an acknowledgment that health has individual and collective aspects, as individuals alone 'cannot achieve environmental protection, hygiene and sanitation, clean air and surface water, uncontaminated food and drinking water, safe roads and products, or control infectious disease.' in any case, considering vertical conflicts between local, state, and federal authorities and issues regarding preemption is essential to reconciling researcher obligations that seem to be inconsistent or in conflict within public health law and ethics: a reader ( nd ed. )) (emphasis added). the interaction of and relationship between the right of privacy and right of public health are both interesting and important considerations; however, given such a discussion requires advanced legal analysis and involves complex legal theory, it has been left for discussion elsewhere. the specific context of a public health emergency. research repositories that cross jurisdictional boundaries could be particularly complicated in this regard when trying to ensure a uniform research experience as well as equitable distribution of risks and benefits. another dilemma highlighted by the sfs case is the considerations of reporting back to research participants' information that is not explicitly described in the informed consent process. further complicating matters in the sfs's case was the fact that their sars-cov- test had not, at the time of their original proposal, undergone traditional regulatory review and approval. the majority of the sfs's laboratories, like many research laboratories, are exempt from the clinical laboratory improvement amendments of (clia) and therefore generally are not authorized to return individual research results by the fda. the fda is the oldest consumer protection arm of the federal government and works to ensure that food, drugs, devices, biologics, and others are trustworthy. nevertheless, since its inception, the fda has been criticized for 'slowing the progress' of medical innovation and for its perceived political bent. an emergency use authorization (eua) under section of the federal food, drug, and cosmetic act (fd&c act) allows for the special use of unapproved medical products during some types of emergencies. these are sometimes called 'medical countermeasures' (and include, for example, in vitro diagnostic tests, personal protective equipment, antivirals, vaccines, and biological therapeutics) that can be used 'to diagnose, treat, or prevent serious or life-threatening diseases or conditions' when there are 'no adequate, approved, and available alternatives.' for example, in the case of sars-cov- , hhs secretary alex azar issued a determination on february , , that covid- 'is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus.' on february , , the fda issued guidance to 'accelerate the availability novel coronavirus (covid- ) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.' this guidance stressed the importance of test validation, limits of detection, accuracy, and inclusivity; recommended the inclusion of a transparency statement that the test has been validated but fda's independent review of this validation is pending on all results; and required laboratories to report positive results immediately to federal, state, and local public health authorities. the return of research results has been a catch- for this reason. if researchers share information that turns out to be inaccurate or misleading, they might be held liable for the erroneous disclosure. alternatively, if researchers withhold information that could be considered clinically relevant, they might be liable for failing to disclose this information. expert panels have recommended that research results be returned with clear disclaimers regarding their potential limited reliability and validity, but participants might not fully appreciate these limitations. liability concerns (at least those related to disclosing the information), however, seem reduced in the context of actions taken in immediate response to covid- , given the liability immunity declaration issued by the hhs. while this immunity declaration unequivocally includes testing for sars-cov- within its scope of covered countermeasures, researchers do not categorically fall within the scope of covered persons. for immunity protection to be applicable, researchers would need to be recognized as 'qualified persons.' it is possible, but not a given, that nih-funded researchers could be within this category. additionally, when considering the return of unexpected research results derived from public health activities, what, if any, considerations should be given to participants right not to know, for example, in the case of sars-cov- antibody testing? while 'right not to know' considerations within the specific context of an oft-fatal infectious disease might seem a stretch, reporting such results might seem contrary to the 'no surprises' principle in biomedical research, (which essentially means that researchers should avoid data practices that fail to align with participants' understanding and expectations). when asked, the many of participants from a variety of different types of research want and expect to receive results back from their research participation. given these expectations, is it necessary to obtain consent to return research results? in the past decade, 'right not to know' has been supported primarily in terms of incidental findings on genetic assay. for many genetic conditions, there are no treatments. however, in the case of results generated as the result of a public health emergency, an individual's right not to know might be supplanted by the public good of informing them. if research resources are later used for public health activities, a question not definitively answered and likely requiring a case-by-case determination is whether reporting of those results should be treated pursuant to research norms (which historically have required consent) or public health norms (which prioritize information access to control the spread of disease over individual preferences). although the return of results might seem like a minor consideration, as 'back to work' certificates are being contemplated by many governments, the implications of whether and which sars-cov- results are to be returned should not be summarily dismissed by researchers or policy makers. such concerns underscore the need for a system of ethical board oversight or other structured consultation, to aid researchers in assessing the risks and benefits of using research resources for public health activities. finally, are there any additional reporting concerns raised by legal mandates to disclose to public health authorities at different governmental levels if consent has not been obtained specifically? public health reporting varies from aggregate, potentially anonymous data (eg, disease prevalence) to fully identifiable data (eg, contact tracing). because public health response toolkits include police powers and the ability to infringe upon individual civil liberties, there are understandable concerns regarding the numerous potential uses for research data that might be generated or seized during a public health emergency. for example, because of the immigration law implications (such as the inadmissibility on public charge grounds final rule), undocumented immigrants might be unwilling to risk seeking health care during the covid- pandemic regardless of public statements from u.s. citizenship and immigration services (within the department of homeland security) that seeking services to test, treat, or prevent covid- would 'not negatively affect' any individual in the public charge analysis. the inclusivity of a research data set being contemplated for use as part of a response during a public health emergency might require careful consideration regarding whether doing so advances or impedes an equitable distribution of the benefits and risks not only of the public health surveillance itself but also (i) the actions taken and policies developed and implemented based on those results made possible with that research resource and (ii) the subsequent willingness to participate in research. one example to highlight this dilemma is contact tracing. public health authorities in other nations have adopted contact tracing to identify networks of exposed people. given that human subject research studies now commonly include connected devices which collect data that could be valuable in contact tracing, this is of particular concern. researchers themselves struggle with appreciating the scope and implications of privacy concerns raised by the scope of big data research, leaving ethics review boards and the participants they serve at a loss. in the public health emergency context, these powerful data might only further obscure variables in the delicate calculus of individual risk and public benefit, underscoring the benefit of establishing formal consultation and review processes for public health activities that would use research data. both the volume and granularity of data collected in research repositories are orders of magnitude greater than it has ever been. however, utilizing these data-as well as the research infrastructure that supports them-in the name of public health response is not without risk. the differing legal and ethical obligations for research and public health activities are worthy of researchers' careful consideration even in the face of a public health emergency imposing powerful urgency constraints on decision-making. to be clear, these tensions should not inhibit research from proceeding during a pandemic nor the transfer of research resources to public health activities per se. rather, it is incumbent upon the research community, including biomedical legal and ethical scholars and practitioners, to reflect upon the many tensions experienced during the covid- pandemic between public health initiatives (the infrastructure and support for which has been proven woefully inadequate in the u.s.) and biomedical research (the leveraging of which might be particularly useful in times of public health emergencies, regardless of the state of public health infrastructure) and consider the creation of a formal consultative process, so that, in the future, research infrastructure might be called upon both responsibly and swiftly to augment public health initiatives. further, as ever larger and more diverse datasets are amassed, the lines between research and public health activities-not to mention clinical care-will continue to blur. the current pandemic highlights the need for each of these communities-researchers, public health authorities, and clinicians-to reconsider the legal and ethical bounds of their mandates and critically examine areas of overlap. active engagement with policy makers is needed. finally, it would be particularly prudent for the research community, equipped with its robust resources and good intentions, to think critically about how to avoid the research enterprise being simply an enabler for the continued neglect of public health in the u.s. a lab pushed for early tests christening of new coronavirus and its disease name create confusion new coronavirus cases confirmed in snohomish, king counties scan: greater seattle coronavirus assessment network public health practice is not research, participatory disease surveillance systems: ethical framework, final rule: federal policy for the protection of human subjects. fed. reg. office for human research protections, activities deemed not to be research implementing a universal informed consent process for the all of us research program how to demand a medical breakthrough: lessons from the aids fight, npr fda moves to rein in drugmakers' abuse of orphan drug law, npr § - , as amended to add section by the project bioshield act of , pub. l. - , and as amended by st century cures act, pub. l. - , u.s.c. bbb- , bbb- a, and bbb- b. for example, during the h n pandemic, the fda issued an eua so an unapproved antiviral drug could be used as a treatment, but the drug was not ultimately approved until . see authorization of emergency use of the antiviral product peramivir accompanied by emergency use information lexi white & sarah wetter, from (a)nthrax to (z)ika: key lessons in public health legal preparedness emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders determination of a public health emergency and declaration that circumstances exist justifying authorizations pursuant to section (b) of the federal food, drug, and cosmetic act, u.s. c. § bbb- policy for diagnostic tests for coronavirus disease- during the public health emergency: immediately in effect guidance for clinical laboratories, commercial manufacturers, and food and drug administration staff returning individual research results to participants: guidance for a new research paradigm declaration under the public readiness and emergency preparedness act for medical countermeasures against covid- , fed at - , as '(a) any person authorized in accordance with the public health and medical emergency response of the authority having jurisdiction...; (b) any person authorized...to perform an activity under an emergency use authorization...; and (c) any person authorized to prescribe, administer, or dispense covered countermeasures in accordance with section a of the fd&c act explaining the 'no surprises principle' as 'assert[ing] that an individual's personal information should never be collected, used, transmitted, or disclosed in a way that would surprise the individual were she to learn about it health research participants are not receiving research results: a collaborative solution is needed health research participants' preferences for receiving research results the right to know and the right not to know revisited: part one, covid- 'immunity certificates': practical and ethical conundrums privileges and immunity certification during the covid- pandemic immunity passports' could speed up return to work after covid- , the gaurdian coronavirus: scientists publish advice to government undocumented u.s. immigrants and covid- , new eng ethical and legal considerations for the inclusion of underserved and underrepresented immigrant populations in precision health and genomic research in the us, ethnic israel unveils open source app to warn users of coronavirus cases, harretz travel log' of the times in south korea: mapping the movements of coronavirus carriers, the washington post singapore says it will make its contact tracing tech freely available to developers, cnbc privacy and security in the era of digital health: what should translational researchers know and do about it? detecting the impact of subject characteristics on machine learning-based diagnostic applications. npj digit med reimagining human research protections for st century science the authors would like to express appreciation to kayte spector-bagdady for formative discussions that helped prompt the development of this manuscript and for constructive feedback on an earlier draft. the content of this article is the authors' responsibility and might not represent the official views of the authors' institutions, funding sources, or any other person or entity. the authors have no conflicts of interest to disclose. key: cord- -vsesv h authors: weiss, barry d.; paasche-orlow, michael k. title: disparities in adherence to covid- public health recommendations date: - - journal: health lit res pract doi: . / - - sha: doc_id: cord_uid: vsesv h nan as the coronavirus (covid- ) pandemic continues, there has been much discussion about the need for, and the public's adherence to, public health recommendations for minimizing spread of the infection. although infectious disease experts recommend social distancing and wearing masks in public, many people do not wear masks and some politicians even want to ban mask requirements (bogel-burroughs & robertson, ) . thus, it is timely that hlrp: health literacy research and practice contains reports of two national surveys about the public's awareness of and intent to comply with those public health recommendations. the surveys used different methods, studied different populations, and have specific methodological limitations. nonetheless, they have important findings-notably marked differences among respondents to the two surveys in their awareness of and intent to comply with those public health recommendations. one survey, by lennon et al. ( ) , collected data from more than , largely white respondents in communities across the united states and found that % to % of respondents most certainly intended to comply with recommendations about hand washing and social distancing. the other survey, by block et al. ( ) , was focused exclusively on african americans and found that only % to % of respondents reported always following those recommendations. readers could easily make the mistake of concluding that the differences in reported compliance with public health recommendations between the two studies are due to the racial/ethnic differences in the two surveyed populations, one largely white and the other exclusively african american. in reality, however, the different levels of compliance with public health recommendations are far more likely due to differences in education and income levels between the respondents in the two surveys. in the lennon et al. ( ) study of largely white people, % of respondents had attained a college or graduate/professional degree. in the block et al. ( ) study of african americans, only % had attained a college or graduate/professional degree. a recent report from the pew research center ( ) confirms that higher levels of education are associated with higher rates of compliance with public health recommendations among people of all racial/ethnic groups. in addition, their data show that overall, african american adults are more likely to wear masks than white respondents (igielnik, ) . higher education levels are also strongly associated with higher income levels (wolla & sullivan, ) , and income is another major factor in whether people comply with protective behaviors during the pandemic. people in the highest income quintile (mean $ , ) are up to % more likely to comply than those in the lowest quintile (mean $ , ) (papageorge et al., ) . the reasons for the relationship between income and compliance are easily illustrated in one of the key public health recommendations-social distancing. social distancing, in many ways, is a "privilege" dependent on financial resources. people with higher levels of education and thus higher incomes, such as those in the lennon et al. ( ) study, tend to reside in less-crowded living situations, making it easier for them to comply with social distancing. people with lower levels of education and thus lower incomes, such as in the block et al. ( ) study, likely live in more crowded housing situations that make social distancing more difficult. based on the above factors, it is reasonable to conclude that the differences in compliance with public health recommendations between the largely white respondents and the exclusive african american respondents were not due to any inherent racial/ethnic characteristics. rather, they reflect different sampling methods that led to enrollment of two survey populations with remarkably different education levels. there are likely other forces also at play that influence adherence to covid- mitigation strategies. they include mistrust of public health messages, politicization of science, and health literacy. mistrust of the health care system has been shown to vary by race, with african americans having higher rates of mistrust (arnett et al., ) . health messaging about covid- has been extremely confusing, rapidly changing, and politically charged. people who mistrust the health care system may be less likely to adhere to recommendations when those recommendations come from sources they do not trust, particularly if those recommendations are unclear and inconsistent. in a recent hlrp: health literacy research and practice article, muvuka et al. ( ) discuss how discriminatory practices and a paucity of appropriate and culturally targeted health information have limited african americans access to health information that is understandable and trustworthy. politicization of the science surrounding how to stop the spread of the pandemic is another factor. there appears to be a massive surge of mistrust in public health recommendations and in science more generally, and these phenomena are playing out along the lines of political partisanship. indeed, last month as the pandemic continued to grow, the majority ( %) of republicans and those who tend to side with republicans believed the pandemic was on a decline, whereas % of democrats and those who side with democrats felt the worst was yet to come (pew research center, ) . finally, it is important to note that neither study included any measures of health literacy. yet, in a journal that focuses on health literacy, it would be an oversight not to question whether lower health literacy among respondents in the block et al. ( ) study may be a contributing reason why respondents were less likely to report adhering to guidelines than among those in the lennon et al. ( ) study, which had an extremely highly educated cohort. without easy access to accurate health information and faced with information presented in difficult-to-understand formats, it should not be surprising if understanding and intent to follow public health recommendations is lower than optimal. indeed, sections of the centers for disease control and prevention webpage with frequently asked questions about covid- are written in text with complexity as high as the th grade reading level (centers for disease control and prevention, ), potentially making it inaccessible to those with limited education and reading skills. clearly, the reasons why the coronavirus pandemic continues to spread, and the reasons why people do not follow public health recommendations are complex and multifactorial. crowded city areas make social distancing challenging. access to health care with timely testing and masks for all segments of the population is critical. social determinants of health that undergird racial and economic disparities are proving to be strong determinants of who will suffer in the pandemic. but we also should not forget one of the basic principles of health literacy-the need to provide easy-to-understand information to everyone. with apparent widespread degradation of the role and importance of public health and science in shaping public opinion, the stakes are large. people are more apt to understand the implications of the pandemic and follow public heath recommendations if they can easily find and understand them. race, medical mistrust, and segregation in primary care as usual source of care: findings from the exploring health disparities in integrated communities study african american adherence to covid- public health recommendations while virus surges, georgia governor sues atlanta mayor to block mask rules coronavirus disease (covid- ). frequently-asked questions most americans say they regularly wore a mask in stores in the past month; fewer see others doing it public intent to comply with covid- public health recommendations health literacy in african-american communities: barriers and strategies socio-demographic factors associated with self-protecting behavior during the covid- pandemic republicans, democrats move even further apart in coronavirus concerns education, income, and wealth key: cord- -af r m m authors: bala, mohamed osman; chehab, mohamad abdelhalim; selim, nagah abdel aziz title: qatar steps up to global health security: a reflection on the joint external evaluation, date: - - journal: glob health res policy doi: . /s - - -y sha: doc_id: cord_uid: af r m m since the commencement of the international health regulations in , global public health security has been faced with numerous emerging and ongoing events. moreover, the joint external evaluation is a voluntary tool developed in compliance with the global health security agenda that represents the high responsibility of international health community towards the increased incidence of emerging and re-emerging diseases. against this background, between th may and nd june , a team of world health organization consultants arrived to the state of qatar to assess, in collaboration with national experts, the country’s capacity to prevent, detect, and rapidly respond to threats of public health aspect. they identified areas of strength, weakness, and recommendations for improving national health security of qatar in anticipation of the fifa world cup event. qatar has demonstrated a leading role in the region through its commitment to international health regulations ( ) and population health. similarly, the qatar was the first arab state and seventh volunteering country globally to undergo the joint external evaluation process. in this review, we highlighted qatar’s achievements and shortcomings of international health regulations’ core capacities to inform healthcare professionals and the scientific community about the country’s contribution toward global health security. since the commencement of the international health regulations (ihr, ) in , global public health has been faced with numerous emerging and ongoing events such as the avian and pandemic flu, cholera, middle east respiratory syndrome (mers) coronavirus, ebola, and recently the zika virus epidemic. these events have hindered any progress in implementing core capacities of the prevention, detection, and adequate response to health emergencies. moreover, the increasing rate and diversity of infectious disease threats jeopardizes the ihr accomplishments and hence the foundations of global health security. against this background, between th may and nd june , a team of world health organization (who) consultants arrived to the state of qatar to assess, in collaboration with national experts, the country's capacity to prevent, detect, and rapidly respond to threats of public health aspect, whether natural, intentional, or inadvertent; in accordance with ihr [ ] . the joint assessment was conducted using the who ihr ( ) -joint external evaluation (jee) tool which is a data gathering instrument encompassing technical areas categorized within three major components; prevention, detection and response. every technical area has multiple questions that will help the evaluators determine the appropriate score [ ] . the jee tool was developed in compliance with the global health security agenda (ghsa) that represents a reaction by the international health community towards the increased incidence of emerging and re-emerging diseases (e.g. ebola, yellow fever, avian influenza, mers coronavirus) and the threat these pose on the global health security due to interconnectedness of today's world [ ] . additionally, the ghsa aims at promoting the adherence and mobilization of the nations of the world behind the full implementation of the ihr as well as the world organization of animal health's (oie) performance of veterinary services pathway, and similar health security frameworks through a multinational and multisectoral approach [ ] . it was established and declared on february in the white house, as an initiative led by the united states of america with committed countries to become a five-year plan focused on empowering public health capacities regarding human as well as animal infectious threats [ ] . the jee process is a voluntary, collaborative process that is comprised of many steps. the first step involved the completion of qatar's country survey through selfreporting data on specific indicators. after which, this information is sent to the external evaluation team as well as subject matter specialists who will utilize this information to establish a baseline for qatar's health security capacity. the third step comprised the site visit by the evaluation team to qatar, where in-depth discussions with the national experts as well as structured visits to vital ministries, healthcare institutions, and the points of entry were conducted to identify strengths, obstacles, opportunities, and priorities. then, the team drafted a final report of the findings according to the predefined indicators and shared it with the state of qatar and after the latter's permission with the international stakeholders and community. interestingly, the indicators evaluated the country's capacity development on a score of to and were color coded, where (color code red) signified the absence of capacity while (color code green) described a sustainable capacity. finally, the evaluation team is expected to conduct a consecutive visit to follow up on the findings and recommendations after approximately years from the last visit [ ] . the evaluation report classically presents the findings through the aforementioned three core components, which are prevention, detection, and response with an additional miscellaneous section (points of entry, chemical events, radiation emergencies). within each of the aforementioned core components, the report reveals the strengths, the weaknesses, and recommendations for improvement based on the technical areas. in general, qatar has demonstrated variable levels of capacity in the different technical areas, with individual scores ranging between (limited capacity) and (sustainable capacity). within this component, the report encompasses many sections, such as: national legislation, policy and financing, ihr coordination, communication and advocacy, antimicrobial resistance, zoonotic diseases, food safety, biosafety and biosecurity, and immunization. the most critical of these areas was the antimicrobial resistance section, where qatar showed limited capacity concerning the antimicrobial stewardship activities. however, qatar has developed capacity (score: ) in most domains: antimicrobial resistance detection, surveillance of infections caused by antibiotic-resistant pathogens, and health care-associated infection prevention and control programs. in order to further build qatar's capacity, one of the best recommended practices to fight antimicrobial resistance is the one health approach. the approach includes an integrated global package of activities to combat antimicrobial resistance across human, agricultural, food, animal, and environmental aspects; which was developed in coordination between the who, food and agriculture organization (fao), and oie [ ] . this practice has been successfully adopted by qatar in response to mers ongoing outbreaks [ ] . interestingly, qatar has established a legal framework to allow the implementation of the ihr through enabling laws and regulations; thus, it has established capacity (score: ) with this regards. however, there are recommendations for further improvement through reactivating a previously established ihr national committee, developing a national framework law and bylaws in a unified official document, and updating decrees as well as laws to enable further ihr implementation. moreover, qatar has developed an immunization program characterized by a national coverage, effective cold chain and distribution, equitable access, and continuous quality control measures. thus, the country attained a sustainable capacity of measles vaccine coverage as well as an established capacity of vaccine access and delivery. also, qatar is currently supporting other countries in the region with their attainment of national measles vaccine coverage as per ihr ( ). (fig. ) . the detection aspect of the report included the following sections: national laboratory system, real-time surveillance, reporting, and workforce development. qatar's scores within this component manifest an established capacity in multiple technical areas; however, the system has only developed capacity (score ) within the laboratory quality system, electronisation and interoperability of the reporting system, analysis of the surveillance data, national field epidemiology training program, and workforce strategy (fig. ) . the role of national laboratory system is emphasized by the jee; where this role is a significant prerequisite for establishing real-time biosurveillance and delivering effective modern point-of-care as well as laboratorybased diagnostics. in addition, the evaluation has revealed an urgent need for better coordination of all laboratories at a central level including the medical, veterinary, and environmental sectors. regarding the reporting system and surveillance data analysis, ihr and oie standards demand complementary and synergistic indicator as well as eventbased surveillance systems. qatar currently has a notifiable disease list, relying mainly on indicatorbased surveillance, where data is collected and input manually due to the absence of an electronic system. the aforementioned goal requires further capacity building through recruitment of new staff as well as further training of those retained, approval and commencement of the new proposed communicable disease control law, establishment of guiding documents (e.g. guidelines, standard operating procedures, case definitions), and applying the one health approach to the surveillance system. importantly, the surveillance system should engage the stakeholder through sharing relevant reports and feedback. in addition, the system must undergo routine comprehensive evaluation for its development. as comes to national field epidemiology and the workforce strategy, the arab board community medicine residency program ( years) is the only locally available program to provide some field training in qatar. thus, establishing a dedicated surveillance and outbreak response training program is recommended; along with a human resource strategy to formulate a clear career pathway and in return allow for the engagement and retaining of homegrown as well as international experts. regarding the response component, the report elaborated on the following issue: preparedness, emergency response operations, linking public health and security authorities, medical countermeasures and personnel deployment, and risk communication. overall, the country has demonstrated good performance within the emergency preparedness and response subsections; where score ranged mostly between and . however, it seems that qatar has demonstrated but not yet established capacity with regards to risk communication, especially the communication systems, intra-and intersectoral coordination, public communication, engaging the affected communities, and rumor management (fig. ) . thus, to develop a comprehensive national risk communication system, there is need for a health sector risk communication strategy, a dedicated risk communication unit at the central level, i.e. ministry of public health, to support the above strategy, mock risk communication emergency exercises within the health sector and nationwide, identification of the target audience in qatar through maps (nationals and expatriates),and strengthening community engagement activities through staff training as well as research and certified course for community volunteers. the others' part of the report involved information about qatar's points of entry, chemical events, and radiation emergencies. in the report, the state of qatar demonstrated a developed capacity (score: ) in the related six technical areas with regards to capacities and public health response at the points of entry as well as the mechanisms and enabling environment for managing chemical, radiological, and nuclear events or emergencies (fig. ) . qatar has six recognized points of entry that support international traffic and four seaports which are the followings: -doha port (mwani ports), used by general cargo ships and container vessels; -mesaieed port (qatar petroleum), used by vessels in the oil/gas sector together with general cargo and container ships delivering goods to the designated mesaieed industrial area; -ras laffan port (qatar petroleum), used by vessels in the oil/gas sector; -al ruwais seaport, used by dhow-type vessels for smaller cargo trade; -hamad international airport, a major international airport and the hub airport of qatar airways; -abu samra ground crossing, the main land entry point to qatar at the border with saudi arabia this reflects recent developments in the transport sector all over the country. one of the aforementioned jee components was that core capacities and potential hazards management should be applied at the points of entry. as a result, it was revealed that qatar has a developed capacity in most technical indicators; despite some deficiencies reported in the vector control program as well as the surveillance and inspection program of vessels for sanitation purposes, especially at seaports' points of entry. multiple stakeholders are responsible for the chemical safety in qatar, including the ministries of interior, defense, industry, public health, and municipality and environment as well as qatar petroleum. to further develop this sector and fortify national health security, it was recommended to establish channels for sharing information across the aforementioned stakeholders, develop a surveillance system for chemical incidents, and enable laboratory detection and analysis of chemicals hazardous to human and environmental health. qatar has demonstrated a leading role in the region through its commitment to international health regulations ( ) and community. similarly, qatar was the first joint external evaluation of ihr core capacities of the state of qatar. geneva: world health organization joint external evaluation tool: international health regulations world bank about | global health security agenda united states: global health security agenda operationalizing the one health approach: the global governance challenges qatar national response to mers-cov; how has one health approach made a difference none. no finding requested for this work.availability of data and materials not applicable. all authors have contributed in manuscript writing and review. all authors read and approved the final manuscript.ethics approval and consent to participate not applicable. not applicable. the authors declare that they have no competing interests. arab state and seventh volunteering country globally to undergo the jee process. in anticipation of the world cup event planned in qatar, the country has a golden opportunity to fortify its capabilities and rectify the weaknesses of its health security system. submit your next manuscript to biomed central and we will help you at every step: key: cord- -assu gue authors: venugopal, vaishali c.; mohan, arunkumar; chennabasappa, latha k. title: status of mental health and its associated factors among the general populace of india during covid‐ pandemic date: - - journal: asia pac psychiatry doi: . /appy. sha: doc_id: cord_uid: assu gue the covid‐ is an international public health emergency and threatens psychological resilience. here we assess the general health status of the public in india during the covid‐ outbreak. a population‐based cross‐sectional study conducted using a general health questionnaire and the relationship between mental health and sociodemographic factors were analyzed. the mean score for the general health of citizens was . . about . % of the elderly and . % of the female population was under severe physiological distress. the prevalence of psychological stress among the general population was higher than expected. hence, there is a need to intensify awareness about the pandemic and should provide mental health management programs. tion was under severe physiological distress. the prevalence of psychological stress among the general population was higher than expected. hence, there is a need to intensify awareness about the pandemic and should provide mental health management programs. covid- pandemic, cross-sectional study, ghq- , mental health, psychological impact | background agencyduring times of a growing pandemic covid- , quarantine, isolation, and social distancing can be mentally distressing to many. most people end up in financial losses and face unemployment, further intensifying people's negative emotions and fear due to covid- coupled with socially disruptive measures such as lockdowns and quarantines (zandifar & badrfam, ) . social distancing is harming the mental health of people more than physical health. this may lead to severe psychological and medical conditions, such as post-traumatic stress disorder, depression, anxiety, panic disorders, and behavioral disorders (zhou, ) . early identification of the behavioral effects of a pandemic is critical to set up community measures and responses. in this context, the present study aimed to examine the mental health status of the general population to understand the psychological impact of covid- lockdown on individuals. besides, the number of factors associated with psychiatric disorders was determined through statistical analysis to identify the high-risk groups. our study can provide valuable information to experts for preventing and controlling risk factors and planning of mental health care programs. a cross-sectional survey intended to evaluate the public's psychological response during the lockdown period of covid- by using an online questionnaire. a snowball sampling strategy focused on engaging the general public on an online questionnaire survey utilized. since the indian government recommended to avoid direct contact during the lockdown period, potential respondents were electronically invited by existing study respondents. data collection took place over days (april to may , ) after one month of declaration of lockdown. collection of details regarding sociodemographic characteristics and factors influencing mental general mental health status were done through pre-structured proforma. the inclusion criteria for selecting the study group was aged above years. sociodemographic data on gender, age, education, residential type in vaishali c. venugopal and arunkumar mohan contributed equally to this work. the past days, marital status, employment status, and current working status and household size were collected from respondents. the psychological state of the participants was assessed using general health questionnaire- (ghq- ), which was developed by goldberg and hillier ( ) . ghq- consists of four sections, each having seven questions related to a physical condition, anxiety, social function, and depression. each question has four-point likert-type items that they are scored according to a - - - system. the score of an individual section has ranged between zero to , respectively, and the overall rating will be between and . as a result, the lower score, better the mental health status, and vice versa. the study group was categorized into with and without psychological distress using a ghq cut-off of (≤ : without a mental disorder, > : with a mental disorder) (sterling, ) . the data were processed using microsoft excel and statistically ana- among participants, ( . %) and ( . %) were in the age group of to and to , respectively, and ( . %) participants were above . the mean age was . years old, and half of these individuals were males. of the study population, . % and . % were unmarried and married, accordingly. the majority of the participants were well educated (degree and above = . %) and employed ( table ) . the general mental health status found to be deficient in ( . %) participants. the overall mean and sd of the public health score was . ± . , which is slightly higher than the threshold value. the average general health score of different age groups was found in the order of older people (above ) > mid-age ( - ) > adults ( - ). while considering gender, the mean score was almost similar for both male ( . ) and female ( . ) groups. however, the prevalence of mental disorders was higher in the female population (table ) . a significant statistical difference in mental health between subgroups of residence type, marital status, education level, occupation status, and the family size was observed. however, there was no significant difference in general mental health between urban and rural populations. the occurrence of psychological stress among the general population was higher than expected. in general, the incidence rate of mental disorder in the present study was higher than the prevalence rate of most of the previous studies conducted using the ghq- method (shirzadi, khazaie, & farhang, ; veisani, delpisheh, & mohamadian, ) . age has been identified as a significant factor; the prevalence of mental disorders increased with an increase in age. these observations were similar to the study by qiu et al. ( ) . the general health score for males was better than the score for females; in other words, women seem to have a greater vulnerability towards developing mental disorders. a direct comparison of this study with existing research is challenging; since the research is performed on a limited population during certain social and environmental circumstances (ie, isolation, lockdown, and social distancing). however, the findings of the current study broadly support several recent studies. (qiu et al., ; sayehmiri, sarokhani, bagheri, & ghanei gheshlagh, ; shirzadi et al., ; veisani et al., ; zandifar & badrfam, ; zhou, ) . the primary limitation of this study was that the subscales of mental health assessment and outcome variables were not studied and some of the potential variables (such as personal habits, physical limitations, chronic diseases, and history of psychological disorders) were excluded since we focused on the impact of recent events over mental health. none. a scaled version of the general health questionnaire a nationwide survey of psychological distress among chinese people in the covid- epidemic: implications and policy recommendations correlation of mental disorders with religious attitude and mental health among the elderly of ilam city mental health survey of adult population in kermanshah county general health questionnaire- (ghq- ) prevalence and gender differences in psychiatric disorders and dsm-iv mental disorders: a population-based study iranian mental health during the covid- epidemic psychological crisis interventions in sichuan province during the novel coronavirus outbreak. psychiatry research, , . how to cite this article: venugopal vc, mohan a, chennabasappa lk. status of mental health and its associated factors among the general populace of india during covid- pandemic no conflict of interest to disclose. data sharing is not applicable to this article as no new data were created or analyzed in this study. https://orcid.org/ - - - key: cord- -or zzjs authors: zhou, liang; zhang, ping; zhang, zhigang; fan, lidong; tang, shuo; hu, kunpeng; xiao, nan; li, shuguang title: a bibliometric profile of disaster medicine research from to : a scientometric analysis date: - - journal: disaster med public health prep doi: . /dmp. . sha: doc_id: cord_uid: or zzjs this study analyzed and assessed publication trends in articles on “disaster medicine,” using scientometric analysis. data were obtained from the web of science core collection (woscc) of thomson reuters on march , . a total of publications on disaster medicine were identified. there was a mild increase in the number of articles on disaster medicine from (n= ) to (n= ). disaster medicine and public health preparedness published the most articles, the majority of articles were published in the united states, and the leading institute was tohoku university. f. della corte, m. d. christian, and p. l. ingrassia were the top authors on the topic, and the field of public health generated the most publications. terms analysis indicated that emergency medicine, public health, disaster preparedness, natural disasters, medicine, and management were the research hotspots, whereas hurricane katrina, mechanical ventilation, occupational medicine, intensive care, and european journals represented the frontiers of disaster medicine research. overall, our analysis revealed that disaster medicine studies are closely related to other medical fields and provides researchers and policy-makers in this area with new insight into the hotspots and dynamic directions. (disaster med public health preparedness. ; : – ) n atural disasters, biological terrorism, nuclear leakage, public health emergencies, epidemic diseases, and other disasters directly threaten the survival and development of mankind. currently, a major disaster occurs almost daily in some part of the world. most population centers are concentrated in high-risk locales like metropolitan cities, which feature very frequent and multiple person-to-person contacts. high-risk occupations, international trade, and housing construction all increase the possibility of human exposure to disasters, leading to increased casualties after each disaster. the ever-increasing spiral of human populations, the rapid growth of technology, swift world-wide travel by millions of persons, and the exponential expansion of at-risk industries and residences combine to increase human exposure to disasters. in particular, the major casualties caused by the wenchuan earthquake, the nepal earthquake, and the indian ocean tsunami pose great challenges to disaster medicine. the wenchuan earthquake was one of the most devastating disasters in the past years and caused more than , casualties; the main causes of death were trauma and crush syndrome. in addition, there was a significant increase in the number of respiratory infections, enteritis, and skin diseases in the week after the earthquake. even a full year after the earthquake, some survivors began to suffer from posttraumatic stress disorder. disaster medicine has attracted global attention gradually by implementing emergency medical treatment, disease prevention, and health care science under the conditions of disastrous damage. after the september attacks, the united states made two major adjustments to the national disaster medical system (ndms) to form a high-efficiency operating mechanism called the national disaster medical rescue system. japan has also established a national rescue medical center in tachikawa city, tokyo. as a data transmission and command center for disaster medical care, it features a disaster medical information system used to determine damage for medical institutions. in addition, japan has enhanced its disaster emergency medical rescues by launching civil and community organizations. after the outbreak of severe acute respiratory syndrome (sars) in , china likewise began to attach importance to the establishment of an emergency medical system. then, after experiencing the wenchuan, lushan, and yushu earthquakes, and observing the actual rescue experience, it built an emergency medical rescue system, including a rescue command center and a medical rescue scene and rescue information platform. disaster medicine scholars have published a substantial amount of original research based on care during disaster rescues, emergency medical treatment, and disease prevention. however, the bibliometric profile of disaster medicine in the literature is still unknown. therefore, in this study, a scientometric analysis was conducted on disaster medicine to estimate the productivity of specific journals, countries, institutions, authors, and research areas, and to identify research hotspots and trends in this field. all of the data for this study were obtained from the web of science core collection (woscc) of thomson reuters on march , (incomplete data existed in ). the woscc, which includes the social sciences citation index, current chemical reactions, and index chemicus, is the most frequently used source of scientific information. the search term "disaster medicine" was used to retrieve titles, keywords, author information, abstracts, and references published from to . the following search string was used: (ts = (disaster medicine)) and languages: (english) and document type: (article or review). the impact factor of each journal was obtained from the journal citation reports science edition, accessed on march , . citespace iii ( bits) was used to analyze publication outputs and construct knowledge maps, to analyze the extracted records for citation characteristics, and to visualize the patterns and trends in disaster medicine. [ ] [ ] [ ] [ ] [ ] a total of studies on disaster medicine, published from to , were retrieved from the woscc (incomplete data existed in ). of these, ( . %) were original articles. although the number of publications increased only mildly from (n = ) to (n = ), the number of citations increased substantially from (n = ) to (n = ) ( figure ). of studies, ( . %) were cited at least once, with an average of . citations per article for , total citations. table shows the most frequently cited articles. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] among these articles, the most common topic was disaster rescue and post-disaster health effects ( of [ %]). the top-ranking paper ( citations) was published in chest and involved critical care treatment: "definitive care for the critically ill during a disaster: a framework for allocation of scarce resources in mass critical care -from a task force for mass critical care summit meeting, january - , , chicago, il." the article provided suggestions to perform triage while allocating scarce critical care resources during a disaster. the studies were published in different journals. the top-ranked journal, which published papers, was disaster medicine and public health preparedness, followed by two other journals with more than papers each: academic emergency medicine (n = ) and american journal of preventive medicine (n = ). disaster medicine and public health preparedness also had the greatest number of total citations (n = ), again followed by academic emergency medicine (n = ) and american journal of preventive medicine (n = ) ( table in the online data supplement). these research studies were published by countries. the top countries published of the studies, accounting for . % of the total number of publications. the country with the greatest number of publications was the united states (n = ), followed by japan (n = ) and china (n = ) ( table in the online data supplement). similarly, among the sponsoring institutions, the top institutions published literatures, accounting for . % of the total number of publications. new york university had the most publications (n = ), followed by the university of washington (n = ) and johns hopkins university (n = ) (table s ). a total of authors contributed to these studies; the top authors accounted for studies, . % of the total. three authors tied for first place, each with publications: m. d. christian, f. della corte, and p. l. ingrassia ( table in the online data supplement). a total of research areas were represented, with the majority of articles focusing on public environmental/occupational health (n = ), general internal medicine (n = ), and emergency medicine (n = ) (table s ). the visualization analysis for reference citations was conducted by citespace iii. the parameters in citespace were as follows: time span = years ( - ); time slicing = ; term type = burst terms; selection criteria (c, cc, ccv) = ( , , ) ( , , ) ( , , ) . the top most cited or occurring items from each slice were selected. the pathfinder network method was used to streamline the network and to map the visualization analysis. the network revealed nodes and lines. in figure , the thicker circle indicates a higher level of between-study centrality. in general, a study with a centrality value equal to or greater than . can be considered a key study; therefore, the key studies were [subbarao i, ] ( . ), followed by [einav s, ] ( . ) and [gillett b, ] ( . ). in addition, the red circles represent burst studies which represent the frontier of a period ; among them, the key burst studies were [subbarao i, ] and [walsh l, ] , which had the highest citation rates between and . figure presents the timeline view for hot keywords. the results show that the hotspots of disaster medicine during this period were spinal cord injury, conceptual framework, health professional, occupational medicine, medical surge capacity, oleic acid, lifesaving intervention, terrorist bombing, developing country, workforce, professionalization and west africa (figure ). in addition, the research papers published in journals represent the frontiers of certain subjects, and the references cited in these papers provide the knowledge base of the papers. in figure , the nodes of clusters # , # , # , # , and # were mainly distributed before (the knowledge base), while the nodes of clusters # , # , # , # , # , # , and # were mainly distributed between and (the frontiers). a total of papers on disaster medicine research were included in this analysis. the visualization was generated by the carrot system based on the first results of a search on regenerative medicine. there were results from the lingo clustering algorithm; the first ranked cluster was practices in disaster (n = ), followed by hospital disaster (n = ), disaster events (n = ), disaster setting (n = ), and earthquake disaster (n = ) (figure ). in addition, the time interval is depicted as a blue line, whereas the time period that represents a burst cited journal is depicted as a red line, indicating the beginning and the end of the time interval of each burst. the top burst references were public health preparedness ( . ), hurricane katrina ( . ), and european journal ( . ) ( table ) . to the best of our knowledge, this is the first scientometric analysis on the topic of disaster medicine. the results indicated a significant increase in the number of publications ( and ) . this increase may be due to several major disasters. the year was the first year after the haiti earthquake, and much of the related research focused on the implementation and development of international medical rescue. [ ] [ ] it was also the third year after the wenchuan earthquake, research on which mainly focused on disease classification and patient management of the patients. [ ] [ ] finally, was the th anniversary of the / attacks; the relevant research mainly focused on post-disaster effects, including respiratory and mental health problems, among survivors and rescuers. [ ] [ ] the united states, japan, and china published the most research on disaster medicine. this may be because the frequent occurrence of disasters in these countries has caused serious casualties and property losses. , [ ] [ ] [ ] likewise, these countries have participated in international humanitarian relief efforts many times, so they have a wealth of medical rescue experience. [ ] [ ] [ ] the top studies (by number of citations) all emphasized a lightweight map of major terms on disaster medicine. burst strength: representing the intensity of the frequency of a key word suddenly increasing over a short period of time. the burst-detection algorithm can be adapted for detecting sharp increases of interest in a specialty. in citespace iii, a current research front is identified based on such burst terms extracted from titles, abstracts, descriptors, and identifiers of bibliographic records. burst-detection algorithms can identify emergent terms; centrality: evaluating the parameter of the number of lines on a certain node, the larger the value, the more the number of lines, that is, the importance of the node in the whole network. disaster medicine and public health preparedness categories of disaster medicine, except for [leaning j, ] , which summarizes the challenges and pressures posed by natural disasters to public health. these categories are disaster rescue , [ ] [ ] [ ] [ ] and post-disaster health effects. [ ] [ ] [ ] [ ] overall, the most cited article was "definitive care for the critically ill during a disaster: a framework for allocation of scarce resources in mass critical care -from a task force for mass critical care summit meeting, january - , , chicago, il," which offers guidance for allocating scarce critical care resources, drawn from a task force on mass critical care. this task force provided several suggestions for managing the triage process when medical systems are overwhelmed. in addition, [devereaux av, ] was sponsored by new york university, which sponsored the greatest number of disaster medicine publications from to . among the authors, f. della corte, m. d. christian, and p. l. ingrassia were the most productive. in their papers, the most cited articles were all associated with the "task force for mass critical care." , [ ] [ ] among the studies of post-disaster health effects, the most cited article was "trends in respiratory symptoms of firefighters exposed to the world trade center disaster: - ," which described trends in post- respiratory and gastroesophageal reflux disease symptoms in wtc-exposed fire fighters. this study also contributed to the literature on public environmental/occupational health, the discipline that produced the most disaster medicine studies from to . based on the co-citation analysis, "a consensus-based educational framework and competency set for the discipline of disaster medicine and public health preparedness" had the highest centrality; it developed a new educational framework for disaster medicine and public health preparedness, based on consensus identification from an expert working group in the american medical association. a time-view map of the co-citation activities appears to the left of the column with the clusters' labels. new clusters include cluster # on spinal cord injury, # on conceptual framework, and # on health professionals; the landmark publications include [subbarao i, ] and [walsh l, ] . they were also the newest burst strength publications, which suggests that "public health preparedness" will become a hot topic in disaster medicine. terms analysis provides a reasonable description of research hotspots (areas of focused attention by a number of scientific researchers, addressing a set of related research problems and concepts), whereas burst words represent new research frontiers (emerging trends and abrupt changes that occur in a timely manner). as shown in figure , the top hotspots of disaster medicine research were: ( ) "practices in disasters." these papers focus on the practical elements of disaster medicine, including the treatment of wounded, effect evaluation, first aid, and disaster medical education. [ ] [ ] [ ] [ ] [ ] ( ) "hospital disasters." these papers also focus on practical elements of disaster medicine, including modular management, humanitarian relief, first aid management processes, and disaster emergency departments. [ ] [ ] [ ] ( ) "disaster events." these papers summarize the casualties of disasters and their impact on public health. - ( ) "disaster settings." these papers focus on the medical needs of the disaster, including medical personnel, medical equipment, and medical technology. - ( ) "earthquake disasters." these papers focus on medical rescues during an earthquake, including the medical decision-making, the rescue process, and the treatment of the special population. [ ] [ ] [ ] [ ] in addition, several burst terms were detected by cite space iii and are considered indicators of research frontiers over time. in the results, the time interval is shown as a blue line, and the time period that represents a burst term category is shown as a red line, indicating the beginning and the end of the time interval of each burst. therefore, the three newest frontiers were: ( ) "impact." these papers focus on post-disaster effects on the physiology and mental health of survivors, including their daily behaviors, physiological indicators, and mental states. [ ] [ ] ( ) "public health preparedness." these papers focus on the establishment, evaluation, and management of medical rescue systems. - ( ) "public health emergencies." these papers focus on the training of emergency personnel, the promotion of emergency technology, and the management of emergency procedures. , [ ] [ ] limitation in this study, although the noise data can be reduced by setting up the requisite statistical parameters in citespace iii, the source of data is limited by a generic search term strategy, which is likely to lead to some noise in the selection of articles. the major findings of the present scientometric study are helpful for all those involved in worldwide disaster medicine research. indeed, this study can help researchers better understand disaster medicine research worldwide and be useful, for example, in choosing appropriate journals for publication and collaborations. fellows choosing an institution for advanced work may also be interested in such an analysis. journals can determine where they stand in relation to other journals in publishing articles related to disaster medicine. governments and policy-makers can also ascertain the most effective countries and institutions in the world in this field, and this analysis may assist them to apprehend and predict the hotspots and dynamic directions of disaster developing health information documentation in disaster update in intensive care and emergency medicine medical action and reflections on china's rescue in nepal emergency medical rescue efforts after a major earthquake: lessons from the wenchuan earthquake the pandemic and all-hazards preparedness act: its contributions and new potential to increase public health preparedness development of the japanese national disaster medical system and experiences during the great east japan earthquake emergency medical rescue major earthquakes: lessons from the wenchuan earthquake emerging trends in regenerative medicine: a scientometric 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injuries arising from the kashmir earthquake: the first h simulation for team training and assessment: case studies of online training with virtual worlds summary of suggestions from the task force for mass critical care summit occupational toxicant inhalation injury: the world trade center (wtc) experience. intern archive occup environ health treatment of posttraumatic stress disorder in postwar kosovar adolescents using mind-body skills groups: a randomized controlled trial a consensus-based educational framework and competency set for the discipline of disaster medicine and public health preparedness in-hospital resource utilization during multiple casualty incidents simulation in a disaster drill: comparison of high-fidelity simulators versus trained actors global liposome research in the period of - : a bibliometric analysis core competencies for disaster medicine and public health knowledge mapping of hospitality research -a visual analysis using citespace disaster relief in post-earthquake haiti: unintended consequences of humanitarian volunteerism haiti earthquake : a field hospital pediatric perspective triage during the week of the sichuan earthquake: a review of utilized patient triage, care, and disposition procedures rescue efforts management and characteristics of casualties of the wenchuan earthquake in china trends in respiratory diagnoses and symptoms of firefighters exposed to the role of academic institutions in community disaster response since physician-diagnosed respiratory conditions and mental health symptoms seven to nine years following the world trade center disaster occupational toxicant inhalation injury: the world trade center (wtc) experience. intern archive occup environ health the great east japan earthquake and devastating tsunami: an update and lessons from the past great earthquakes in japan since the academic health center in complex humanitarian emergencies: lessons learned from the haiti earthquake awareness of disaster reduction frameworks and risk perception of natural disaster: a questionnaire survey among philippine and indonesian health care personnel and public health students medical emergency rescue in disaster: the international emergency response to the haiyan typhoon in philippines summary of suggestions from the task force for mass critical care summit definitive care for the critically ill during a disaster: a framework for optimizing critical care surge capacity -from a task force for mass critical care summit meeting trends in respiratory symptoms of firefighters exposed to the detecting and visualizing emerging trends and transient patterns in scientific literature trends in respiratory symptoms of firefighters exposed to the regional anesthesia for painful injuries after disasters (rapid): study protocol for a randomized controlled trial assessment of the scope and practice of evaluation among medical donation programs. globa health are belgian military students in medical sciences better educated in disaster medicine than their civilian colleagues? evaluation of a new communitybased curriculum in disaster medicine for undergraduates practical "modular design" research of emergency drug supplies in hospitals extending a helping hand: a comparison of israel defense forces medical corps humanitarian aid field hospitals capabilities for clinical management of radiation injuries of the nikiforov russian center of emergency and radiation medicine (emercom of russia) observation services linked with an urgent care center in the absence of an emergency department: an innovative mechanism to initiate efficient health care delivery in the aftermath of a natural disaster mass disasters observed at the sapienza university of rome: a retrospective study between ebola, quarantine, and the scale of ethics lessons from the earthquake(s) in nepal: implication for rehabilitation a community-led medical response effort in the wake of hurricane sandy education in disaster management: what do we offer and what do we need? proposing a new global program portable ultrasound in disaster triage: a focused review coping behavior and risk of posttraumatic stress disorder among federal disaster responders prepared for what? addressing the disaster readiness gap beyond preparedness for survival equilibrium decision method for earthquake first-aid medicine allocation based on demand information updating transfusion under triple threat: lessons from japan's earthquake, tsunami, and nuclear crisis nepal earthquake: analysis of child rescue and treatment by a field hospital the tohoku medical megabank project: design and mission predictors of decline in iadl functioning among older survivors following the great east japan earthquake: a prospective study effect of evacuation on body weight after the great east japan earthquake what are the most common domains of the core competencies of disaster nursing? a scoping review knowledge levels and training needs of disaster medicine among health professionals, medical students, and local residents in building community disaster resilience: perspectives from a large urban county department of public health assessing disaster preparedness among latino migrant and seasonal farm workers in eastern north carolina association of community health nursing educators: disaster preparedness white paper for community/ public health nursing educators characteristics of effective disaster responders and leaders: a survey of disaster medical practitioners national differences in regional emergency department boarding times: are us emergency departments prepared for a public health emergency this study was supported by the third military medical university military doctoral program (no. jskt ).lz and pz conceived and designed the paper. lz, nx, and sl wrote the article. zz, lf, st, kh, lz, and pz collected and analyzed the data. sl provided critical revisions. all authors approved the final version of the paper. to view supplementary material for this article, please visit https://doi.org/ . /dmp. . key: cord- -t gj k authors: nicholas, david b.; gearing, robin e.; koller, donna; salter, robyn; selkirk, enid k. title: pediatric epidemic crisis: lessons for policy and practice development date: - - journal: health policy doi: . /j.healthpol. . . sha: doc_id: cord_uid: t gj k abstract objectives this research study addresses health policy and patient care considerations, and outlines policy and practice implications resulting from a crisis in a pediatric setting. this crisis, an epidemic outbreak of severe acute respiratory syndrome (sars), dramatically impacted the delivery of health care in canada. despite the passage of time since the last diagnosed case of sars in april , researchers have warned the global community to be prepared for future outbreaks of sars or other infectious diseases. methods qualitative interviews were conducted with participants representing key stakeholder groups: (a) pediatric patients with probable or suspected sars, (b) their parents, and (c) health care professionals providing direct care to sars patients. results participants conveyed key areas in which health policy and practice were affected. these included the development of communication strategies for responding to sars; easing vulnerability among all stakeholders; and the rapid development of practice guidelines. conclusion given the continuing threat of current and future airborne viruses with potential for epidemic spread and devastating outcomes, preparedness strategies are certainly needed. effective strategies in pediatrics include practices that provide family centered care while minimizing disease transmission. toward this end, lessons learned from previous outbreaks merit consideration and may inform future epidemics. kong and infected other travelers, who then journeyed internationally to countries such as vietnam, singapore, germany, and canada. by july , , sars had claimed lives and affected individuals, across different countries [ , ] . the sars outbreak of was characterized by its unprecedented rapid, airborne, and global transmission; however, its localized impact was particularly felt within health care facilities [ ] [ ] [ ] . infection control leaders and researchers have warned the global community to be prepared for future outbreaks of sars or other widespread infectious diseases [ , ] . while several studies have identified biomedical data and psychosocial impacts, lessons learned from sars for both health policy and patient care, have received little research attention. accordingly, this paper addresses this gap in the literature and outlines policy and practice implications of sars, specifically from a pediatric perspective. this research was achieved through a series of descriptive qualitative interviews with key stakeholders, including pediatric sars patients, their parents, and health care providers who provided direct care to sars patients. sars presented a health care crisis, within affected regions, by requiring rapid responses to unknown questions, with devastating consequences for patients, health care providers, and health care systems. as new struggles emerged on a daily basis, responses and implementation were immediately necessitated. policy considerations that affected day-to-day patient care comprised infection control and patient care protocols as well as integrated change and in some cases a sense of systematic chaos. virus spread was ultimately contained in hospitals through restricted entry as well as limited movement within and between health care facilities. screening processes elicited information about individual exposures, symptoms, and epidemiologic links to sars [ ] , and hospital entry was restricted on the basis of this reported information. visitors to hospitals were largely eliminated except for immediate family members of critically ill, dying, birthing or pediatric patients [ ] . even in these critical situations, pediatric patients were limited to only one parent visitor at a time, although in some cases, children had no visitors. to limit virus transmission, health care providers deemed 'non-essential' were restricted from pediatric care. 'essential' hospital caregivers were permitted to work at only one health care facility to reduce the risk of virus transmission, and were required to wear protective masks and gowns in patient care areas [ , ] . when treating patients with suspected or probable sars, double isolation gowns, hair caps, masks, face shields, and gloves were required [ ] . negative pressure isolation rooms with antechambers were used for patients thought to have sars, and staff were required to remain outside negative pressure isolation rooms as much as possible [ ] . clearly, sars resulted in substantial changes to health care practice and frequent shifts in infection control requirements, with health care providers reporting substantial frustration and anxiety [ ] . direct face-to-face clinical communication between physicians and families was interrupted and replaced by increased reliance on the telephone as the primary mode of communication [ ] . world regions varied in terms of methods and policies implemented to foster communication. visitation restrictions in an identified asian hospital were mitigated through video conference and e-mail technology [ ] , while canadian hospitals generally relied on telephone communication [ ] . in pediatric care, some children with sars reportedly kept the phone line open with parents and families over extended periods of time. phone connection emerged as a key factor in reducing isolation and despair yet even with phone support, children often and dramatically suffered extended negative psychosocial symptoms [ , ] . systems of health care delivery were dramatically affected by the sars crisis; however, few studies have focused on the policy and practice implications of the outbreak. to address this gap, a descriptive, qualitative investigation was conducted to examine the experiences, impacts, and implications of sarsrelated health care policies for patients, parents, and health care providers. given the limited research in crisis response within pediatrics, a descriptive qualitative study was conducted in determining issues of salience that emerged during the epidemic of sars [ ] . semi-structured, qualitative interviews were conducted with participants from key stakeholder groups affected by pediatric sars as follows: pediatric patients between the ages of and years (n = ), their parents (n = ), and frontline pediatric health care providers (n = ). as the pediatric crisis of sars in canada was relatively localized, we attempted to include all eligible pediatric sars patients and their parents, as well as the respective health care provider. all participants were interviewed months after hospitalization to provide time for experiential reflection and patient recovery. interview questions invited participants to systematically document and identify their experiences; perceived policy and practice implications of sars; and lessons learned in the event of a future outbreak. patient participants were recruited from a database of all children in toronto admitted to hospital for suspected or probable sars (a classification clinically determined by fever and/or radiographic evidence of chest pathology). while children under years of age were also admitted with probable or suspected sars, they were not interviewed due to their young age; however, parents of these young patients (n = parents of young children) were included in the sample of interviewed parents. sampled children and parents represented a range of cultural backgrounds, and all children ultimately recovered from sars. health outcomes for parent participants ranged from full recovery to death. interviewed health care providers comprised physicians and nurses who provided direct care to pediatric sars patients. in terms of young children interviews were adapted for developmental level, and skilled child life specialists utilized play, hospital/medical photographs and toys for engaging children and eliciting their reflections as guided by methodological guidelines for qualitative interviewing with young children [ ] [ ] [ ] . the semi-structured interviews were conducted in person, were audio-taped and were transcribed verbatim. a semi-structured interview schedule provided a series of open-ended questions to ensure coverage of similar topical content among all interviewees [ ] . qualitative research computer software assisted in data analysis, and inter-rater reliability was achieved through blinded reviews of data, followed by reviewer agreement on emergent findings. institutional ethical approval was received prior to study commencement. interviews were subjected to content analysis, concept saturation, and theme generation, using mccracken's [ ] well-established 'long interview' method comprising the following sequential analytical processes. . line-by-line coding seeking notable observations in the text that address the research questions. . developing each observation in and of itself from evidence within a single transcript through data categorization. . examining the interconnection of observations in subsequent transcripts through inter-transcript categorization. by this point, themes and an organizational schema were emerging. . emergent themes were scrutinized in collective form for "patterns of intertheme consistency and contradiction" (p. ). redundancy was eliminated and themes were organized theoretically. by this time, the focus was no longer on particulars of individual perspectives, but rather on principles inherent in themes. data provided a range of participant experiences and perceptions about their experience of sars. perceptions yielded both experiential and descriptive information, but also important issues for consideration in health policy and practice planning. key themes include: interrupted informational flow during the sars outbreaks; vulnerability and moral doubt; need for effective and responsive leadership; and expedient development of practice guidelines in the shifting landscape of pandemic outbreak. each dominant theme is documented below, along with the frequency of identification (presented in percentages) and verbatim quotes (in italics) that demonstrate their application within interviews. each theme is clearly supported with 'thick description' [ ] from interviews/transcripts. information about sars was disseminated through various global, national, and regional sources includ-ing the world health organization (who), provincial health authorities, and local health care administrators. information was relayed to health professionals providing sars care in an attempt to quickly adapt patient care and limit transmission. while participants required and appreciated the ongoing updating of information, the frequency of incoming and shifting information yielded difficulty in its assimilation and implementation. the majority of health care providers ( %) reported substantial workplace stress given frequently changing patient care standards in the face of a life-threatening illness. they described vicarious strain when implementing and justifying restrictions and then, in some cases, enacting policy changes. a health care provider explained: it was hard in terms of the families. one day you would be doing something and another day it would be different. and explaining that to the families was difficult . . . i know it's scary for patients and families when they see you do one thing one day and something different the next day. participants described continuous informational updates during sars, resulting in frequent changes of practice expectations. central coordinating structures for information dissemination were reported as insufficient, resulting in discontinuity in how information was transmitted. clearer information was advocated by % of these children. many of these children who had been admitted to, and isolated within, the sars unit experienced little or no physical symptoms characteristic of sars. as such, their ability to make sense of policies which mandated their hospitalization and separation from parents was confusing, particularly for the younger children. they repeatedly expressed in interviews the need for clear explanations to help children understand these realities: "(children) should know what is going on and why little kids have to be quarantined." in some cases, children expressed misconceptions in terms of their understanding of sars and associated infection control procedures. the following excerpt from an interview with a child admitted to the sars unit illustrates some of the confusion and mystery surrounding reasons for quarantine: child: "it was like no one could leave the room so you can't leave your room." interviewer: "what do you think would have happened if you left your room?" child: "i'd get into trouble." increased understanding about the unknown infection risk may have increased this child's understanding of the reasons for isolation and quarantine. as time progressed during the crisis, children increasingly understood the rationale for patient care policy changes and visitation restrictions. this resulted in children being more informed and understanding, and also expressing fewer fears over the changes in health care. however, explanations directed to children could have occurred much earlier which, participants suggest, would have fostered adherence. this finding is consistent with earlier sars literature which suggests that greater explanation of reasons for protocols such as quarantine, is linked to increased compliance [ , ] , and highlights the significance of ensuring that children, as major stakeholders, receive the information they need in developmentally appropriate ways. these findings suggest that the flow of information in pediatric settings presents unique challenges for health care providers, particularly in ensuring that information is as comprehensible as possible, yet also as simple and clear as possible even for the very young child. the majority of health care providers ( %) recognized the importance of their work, yet grappled with concerns related to personal vulnerability and the impact of sars policies on patients and families. the uncertainties about sars transmission ignited anxiety in every health care provider ( %), while simultaneously fostering a sense of obligation and commitment to patient care. as one health care provider explained, i do it for the kids, as long as i knew that i was helping them and they developed such a trusting relationship with us. we were the ones they were seeing most of the time. so if you could make them smile, or if you could just be in there to comfort them, then it was worth it. you kind of put aside your fear knowing that the kids are probably times more afraid than you are. so i would go in there and do what i needed to do. make them happy. that's what it was like for me. my priorities were always the child, the patient and you do your best and make them as comfortable as possible. all health care providers ( %) expressed heightened turmoil as a result of seeing children in isolating and vulnerable circumstances. they were aware of parents' serious health conditions, sometimes more so than the children. tensions among health care providers included moral conflicts when withholding information or enforcing limitations on family involvement in children's care. policies resulted in quarantine and isolation for children and their families, and families ( %) reported experiencing anxiety and loss. these findings are congruent with previous research which has also found that patients quarantined for sars experienced feelings of uncertainty, separation, rejection, and stigma [ ] . a parent exemplified this loss by stating, "being separated from (your children during hospitalization) . . ., you almost feel like you've lost them. you feel hopeless." in turn, most frontline health care providers ( %) grappled with the conundrum of being responsible for enforcing policies of isolation and quarantine, while realizing the devastating impact on children and families. beyond experiencing moral and family-centered care dilemmas, health care staff ( %) worried about becoming infected by the virus and taking it home to their own families. a health care provider described a pervasive sense of stress and fear: i was mostly afraid because i have a family. i have a young child and i was afraid of bringing this, whatever it was, home. so when i came home, i would quickly shower before my child would see me and put my clothes in the laundry. . .i was more fearful than i would admit to others. this sense of fear and vulnerability were re-ignited when precautionary measures were intensified, as a health care provider illustrated below. at one point in time, we went to double masking, double gloving and double gowning. it made us secondguess all the days before that we hadn't done that. had we put ourselves at risk? had we put our staff at risk? the intensity of perceived risk and workplace hazard left health care providers feeling, "vulnerable . . . physically, mentally and emotionally." to address these needs, most staff ( %) reported the importance of collegial support and camaraderie, as illustrated by a health care provider's comment, "the way the team functions is important in supporting team members, and recognizing, or helping people recognize, when perhaps they are overdoing it and becoming too stressed." yet several health care providers ( %) described a lack of support from colleagues and others in the community. despite placing themselves at risk by providing sars care, some health care providers perceived limited institutional recognition, which resulted in, "unrest [among health care providers] who thought they were not appreciated and that nobody listened to them." while support from colleagues was generally acknowledged, collegial respect and etiquette was, in some cases, lacking. in some cases, the emotional toll of these difficult experiences was described to be substantial and long-standing. beyond workplace strain, nearly all health care providers ( %) were often advised by family and friends to "stay away" from social or family events. they described ostracism and loneliness in being unwelcome at a time when informal support and workplace distraction was acutely needed. most health care providers ( %) outlined the importance of strong, focused leadership and effective crisis management during health crises such as the sars outbreak. regional leaders and decision makers were praised for their diligence, yet their professional preparedness for this role was also questioned. as one health care explained, this is a kind of infectious epidemic situation that requires a stronger public health input, a stronger infection control input, and a stronger infectious diseases input -working together with someone who understands crisis management. and although at the time it sounded logical, i'm not sure that emergency room people really understand the broader scope of crisis management. coordination of sars-related decisions and resulting tasks required new solutions and systems for unprecedented problems [ ] . as an example, a health care provider described a decision-making process for obtaining sufficient infection-control masks: someone said, 'we're going to need , masks', and someone else asked, 'how many masks?' he looked to someone with him and asked, 'how many do we have?' and that person said, ' . how are we going to get ?' the response was, 'we'll tell you tomorrow.' the next day's report was, 'we have , coming from the u.s. on friday, we can get another. . .' so that's the way people worked. 'so and so is responsible for setting up the screeners. who's going to educate the screeners?' 'i'll take care of that'. in responding to immediate demands, flexibility, and camaraderie resulted from working together toward timely solutions. a health care provider described effective teamwork as essential to crisis management and patient care. the need for rapid solutions and decisions necessitated central coordinating systems for distilling incoming information and implementing responses. cohesive and decisive leadership, as well as using effective communication and dissemination methods, were crucial. unfortunately, the rapidity and apparent imminent risk, inherent in sars, limited long-range strategic planning in establishing systems of coordination. one health care provider explained, i think the whole thing has made us all a lot more aware that unexpected things do happen. you can't always be prepared for it. you do the best you can do working together as a team. due to the unprecedented nature and magnitude of the crisis, practice guidelines had to be rapidly developed and immediately implemented. this included infection control policies as well as staffing orientation and care practices. developing practice guidelines was particularly unsettling given that there was little precedent or evidence to guide decisions and policies, which often had a monumental impact on care delivery. a health care provider described the local approach for pediatrics: quite early on we established our own set of guidelines, what we thought was the most reasonable approach based on what the adult-centered institutions were doing and in part on what hong kong was telling us. by then we had admitted some of our early cases who were kids. but we didn't know what was going to happen to them. toward the development of practice guidelines, international communication was immediately mobilized using advanced technology. websites provided localized patient care guidelines and teleconference meetings brought together key stakeholders in affected regions. in providing responsive and decisive leadership, networking was critical in spreading site information and soliciting guidance for local treatment strategies. advanced telecommunication clearly added capacity for the immediacy of information dissemination and, as such, technology permitted a timely forum for developing and sharing practice guidelines. yet while immediacy of information increased clarity, it simultaneously informed the health care community of the 'moving target' of sars; thereby, increasing confusion and uncertainty, as a health care provider reported below. (macro-level health bodies) sent out directives and expected hospitals to comply with the directives. then the next day another directive came, which might contradict the first one. there was a lot of confusion and it was hard to interpret what they were saying. sometimes we would look at the directives and say 'that doesn't make any sense' or 'that doesn't really apply to us, i don't see how we can implement something like that.' confusion, inconsistency and sometimes irrelevance of guidelines, were described at various levels of patient care. a parent reported that constant changes in infection control procedures became "a new norm." accordingly, inconsistent patient guidelines during sars appeared to preclude ease of understanding, integration and appreciation of the imposed restrictions. in recommending preparation for any future outbreak of sars or similar infectious disease, participants advocated the rapid development of protocols and procedures. fostering an organized and systematic response to a crisis with clear guidelines was viewed as a means to potentially ease patient care ambiguity, as a health care provider explained below. hopefully there won't be as much confusion the next time around (because of the development of) protocols. we know what the routine will be; it'll be a lot more organized. health care providers described 'relief' over the eventual development of concrete sars protocols. they stated that protocols established frameworks upon which decisions could be based. accordingly, such protocols were thought to offer the potential to diminish the chaos that prevailed during much of the sars outbreak. health care responses to the sars crisis yielded clear implications for patients, families, health care providers, and the larger community. imposed restrictions had far-reaching and substantial impacts on community and health care functions. the familycentered nature of pediatric care emphasizes the importance of openness and accessibility among children, parents, and health care providers. however, the health care response to sars necessarily constrained this bedrock of pediatrics due to communal uncertainty and the risk of virus spread. patient and family isolation emerged, as did shifts in professional roles and levels of vulnerability. simultaneously, confusion at best, and chaos at worst, emerged for patients, their families, and health care providers. participants conveyed key domains in which many were profoundly affected; each domain yielding implications for health policy and clinical practice in the event of a future major disease outbreak. accordingly findings speak clearly to the need for: systematic and well-orchestrated information flow; communication strategies in responding and disseminating relevant information; means to ease vulnerability among stakeholders; strategies for ensuring effective and responsive leadership; and the development of practice and policy guidelines for treatment and contingency planning for an unknown patient care path. although these findings specifically apply to, and are drawn from, a pediatric perspective, they also have relevance for consideration in an adult-based care. lessons learned from the recent sars outbreak can inform pandemic and crisis planning. in the management and containment of sars, for instance, communication technology necessarily and exponentially increased the rapidity of information flow within the health care community. however, this knowledge dissemination often simultaneously left insufficient time to assimilate and adjust to presenting circumstances and new information. there is a need for information translators and communication strategies that can swiftly respond to shifts and apply criteria to information dissemination and application. including an ethical framework seems important in managing competing priorities according to relevant pathways of decision making. for example, equipment use in the event of shortage or rationing will require ethicallybased criteria that simultaneously and perhaps, in tension, grapple with multiple and complex considerations for best decision making amidst competing demands. sars clearly exemplified value-based crisis, particularly as we looked at issues and conflicts from the perspective of multiple stakeholders at different organizational positions. applying a systems perspective [ ] , whereby feedback to the system is recognized [ ] [ ] [ ] , the occurrence of sars constituted a massive environmental 'shift' within the local and global community. in the case of sars, the environment provided stimuli and feedback that was exceedingly divergent and unprecedented to be easily managed within existing health policy, communication structures, and response systems. current health policies and communication structures appeared unprepared to integrate and manage the immense volume and fluctuations of incoming and outgoing information amidst intensified uncertainty and risk. the responsive nature of systems, within a systems theory orientation, is typically viewed as adaptive and able to respond to environmental feedback [ ] . however, feedback relating to sars strained existing policy and practice frameworks of logic during the outbreaks. the daily shifts in infection control and patient management procedures often surpassed professionals' ability to assimilate, let alone master, new tasks of 'routine' care. status quo was negated and a new norm emerged comprising change, confusion, and disequilibrium. stability of policy thus became an 'unattainable anomaly,' which was echoed in frequent policy shifts, detailed media portrayals of a regional health crisis, and a prevailing environment of uncertainty and unknown risk. rather than moving toward stability and homeostasis, chaos emerged as the expected yet irreconcilable 'norm' [ ] of daily health care delivery. for frontline health care providers, uncertainty and anxiety were heightened as infection control precautions intensified. fear of personal exposure to sars increased as individuals realized that new standards of infection control had heretofore not been followed (prior to the intensification of the infection control policy). perceived vulnerability appeared to be pervasive, yet a sense of duty to patient care motivated continued work and, therefore, risk. ongoing confusion and tension were expressed by frontline staff who described existing within an environment of risk, workplace chaos, and personal emotional strain. sars related policies sought to routinize patient care within non-routine conditions. this required attempts to balance risk management and quality of life through continual justifications of the system to accommodate changing information. while stakeholders understood the need for policy shifts, they lacked an understanding that chaos was, under the presenting risks and uncertainty, a reasonable "norm" [ ] and they did not appear to have accessible means to 'streamline' or control the presenting volatility. as an example, information was transmitted through various means and sources. systematizing the flow of information, a means of adding predictability and order, may have increased health care staff's ability to rapidly assimilate, apply new learning and routinize constantly shifting data. moreover, increasing stakeholders' collective knowledge about means of managing this new state of disequilibrium may have 'normalized' or provided tools for handling chaos during this time of abnormality [ ] . in future planning, developing contingencies and frameworks to minimize and/or routinize environmental chaos, as experienced during sars, may assist stakeholders in assimilating information, managing uncertainty, and developing contingency plans. consistent lines for the incoming flow of information, analysis, and outgoing dissemination may foster coordination by effectively discerning emergent circumstances, their parameters and best practices in information dissemination. at times of outbreak and crisis, human resource sustainability and morale maintenance are crucial, particularly when heath care providers themselves are at considerable risk of disease infection. based on widespread vulnerability, fear and social stigma, stakeholders, including patients, family members and health care providers, emerged as populations at emotional and physical risk. the development of patient, family and workplace risk assessment processes and psychosocial assistance are critical. in the sars crisis experience, tangible appreciation and recognition for frontline health care providers appeared to be desirable and needed. finding ways to meaningfully recognize the fortitude and contribution of direct practitioners may go a long way in encouraging and sustaining these key stakeholders. the crisis of sars clearly had a multifaceted impact on health policy and practice as well as on the personal and professional lives of affected individuals and families. examining the occurrence of the recent sars outbreaks provides experience for future crisis contingency planning. planning strategies include rapid virus containment, seamless and coordinated communication, humane and accessible care, effective leadership, and the timely development (or adaptation) of practice guidelines. toward this end, strategies include the creation of preparedness guidelines, competency and capacity-building, and the development of a quorum of skilled and deployable health care professionals and epidemiologists. given the continuing threat of current and future airborne viruses with potential for epidemic spread and devastating outcomes, preparedness strategies are integral to responsible health care planning. the sars crisis provides us with tangible lessons and a template from which innovation can incorporate practical, ethical and multisectoral elements in devising a pandemic plan. koch's postulates fulfilled for sars virus world health 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sars an ethnographic study on the psychosocial effects of sars: perspectives of hospitalized children, their parents and pediatric health care providers whatever happened to qualitative description research with children: perspectives and practices focus on qualitative methods: interviewing children interviewing strategies with young people: the 'secret box' stimulus materials and task-based activities the long interview. thousand oaks: sage thick description: toward an interpretive theory of culture the experience of quarantine for individuals affected by sars in toronto factors influencing compliance with quarantine in toronto during the sars outbreak management of suspect sars patients: an opportunity to redesign isolation protocol new directions in systems theory: chaos and complexity cross-scale interactions, nonlinearities, and forecasting catastrophic events nonlinearity in the epidemiology of complex health and disease processes chaos theory: an alternative approach to social work practice and research planning and chaos theory key: cord- -fa mxvc authors: svadzian, anita; vasquez, nathaly aguilera; abimbola, seye; pai, madhukar title: global health degrees: at what cost? date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: fa mxvc nan in theory, global health, as a field, takes pride in principles such as equity, fairness, reciprocity and bidirectional partnerships. in practice, many aspects of global health are dominated by individuals and institutions in high-income countries (hics) who seem to benefit more than their counterparts in low-income and middle-income countries (lmics). [ ] [ ] [ ] global health organisations are mostly head-quartered in hics, and run by people, primarily men, from hics. further, authorship of global health publications is dominated by people in hics, [ ] [ ] [ ] as well as editorial boards of global health journals. what about global health education? in the past two decades, global health has become very popular among students in hics. in response to higher demand and availability of increased funding, many hic universities invested heavily in global health programmes. although dozens of degree programmes in global health emerged as a consequence, it remains unclear who the target audience really is, and what it might cost to earn one of these degrees. are these degree programmes aimed at lmics, where training gaps are enormous, or are they primarily for the benefit of hic trainees and institutions? to answer this question, we identified academic programmes that offer either a master's of global health or a master's of international health degree. we used the academic global health programmes database maintained by the consortium of universities for global health (cugh), supplemented by online searches for universities not included in the cugh list (see box for details). we focused on master's of global or international health programmes (on campus or online), rather than related degrees such as master's of public health (mph) which might offer global health concentrations, options or tracks. in all, out of global or international health master's degrees identified, we were able to gather information for degree programmes, as of march . table outlines details for each degree programme considered for this analysis. as shown in figures , ( %) were located in north america, ( %) in europe, ( %) in western pacific, ( %) in asia and ( %) africa. nineteen ( %) of the degree programmes were -year programmes, and the rest could be completed over a longer period. of the degree programmes, five ( %) were entirely on-line (distance education), while the rest were on-campus. results for average tuition fees for master's degrees in global or international health are displayed in table . on average, across all degree programmes, the mean tuition fee was us$ for international students-usually defined as students who undertake studies outside their country of residence-and us$ for domestic students-usually defined as students who undertake studies in a country where they hold citizenship or other documented residency status. most programmes in our analysis ( %) were based in hics, with an average tuition of us$ . the mean tuition fee for online-option degrees (degrees which can be completed either in part or in full away from the traditional campus setting) was us$ vs us$ for on-campus programmes. on average, tuition for programmes in privately funded schools were considerably higher than for public schools, us$ and us$ , respectively. for the programmes in the usa, the average tuition fee for all students was us$ . there was little difference between domestic and international student fees (us$ for domestic vs us$ for international students). for programmes in the uk, the average tuition fee was us$ for domestic vs us$ for international students. in nordic countries (i.e., sweden and norway), the tuition was us$ for domestic students but an average of us$ for international students. interestingly, the degree programmes in asia and africa were associated with a high cost, with the master's in global health delivery in rwanda costing us$ , and degrees in asia costing, on average us$ . as previously mentioned, there is a large divide between tuition fees at public vs private institutions. this is underscored by the fact that the least expensive programme was at the university of bergen where tuition fee is us$ since, as stated on their webpage, public universities in norway do not charge students tuition fees, regardless of the student's country of origin. it is within their mandate as an institution and part of the country's general ethos to provide quality education to its students and future leaders at no cost. this philosophy is quite different from their counterparts in the usa where of the private schools are located and where the most expensive programme identified is based at duke university (us$ ). table compares the tuition fees for domestic vs international students. it shows that on average hic programmes charged higher fees for international students ( . times higher on average), while lmic countries charged the same for both international and domestic students. however, by looking at table , it can be noted that american schools generally charged the same for both categories of students. figure provides data on relative costs of living in each location as a function of the cost of attendance for international versus domestic students. using the united nations postadjustment multiplier as a proxy for cost of living, the scale of the circles is relative to the cost of living of each city; smaller circles represent locations that are less expensive to live in relative to its headquarters in new york city. while cost of living is relatively expensive for many european locations, these costs are offset by less expensive tuition fees. the same cannot be said about north american schools; many are located in cities with similarly high costs of living, yet tuition fees are much higher than for european schools. figure box lack of transparency: the approach and limitations to our analysis data were extracted by two authors (as and nav) with any discrepancies in double entry agreed on by consensus. for each degree programme we identified, we visited websites of these programmes and collected data on the tuition fees for international versus domestic applicants. we also emailed coordinators of the degree programmes to request clarifications or additional data, if needed. we focused on tuition fees for the entire degree programme rather than the annual tuition fees, since duration of degree programme varied from to years, with some degrees structured in such a way that students' graduation time was tied to their experiences and training garnered prior to programme entry. thus, it should be noted that when the final cost was calculated this was based on the typical time to graduation indicated either on the website itself or by the respective school's programme coordinator. in most european schools, fees are fixed regardless of how long a student takes to complete their degree. however, in north america time to graduation can be quite variable and students usually pay tuition for each semester or credit. this is particularly true of the us system where a degree cost can vary substantially between students. we chose to calculate total tuition based on a typical student's experience as suggested by either the school's website or the coordinator. in addition, some programmes require a project (eg, summer practicum) be conducted in elsewhere (typically, a low-income and middle-income countries (lmic)-the costs for these were not always absorbed by the tuition fees. while some students had their costs for projects abroad covered by a supervisor and others could apply for scholarships, the remainder would have to pay for the additional costs out of pocket. this information was not transparent across degree programmes. given the difficulty in collecting data on tuition itself, we did not quantify cost of living directly for each school. rather, we aimed to account for differences in living costs for any given school using an adjustment measure used by the international civil service commission (icsc), established by the united nations (un). the un postadjustment system is designed to ensure that the net remuneration pay of un staffers garners an equivalent purchasing power to that same staffer at the base of the system, new york city, regardless of their posting location. post adjustment multiplier considers differences in prices between the city in question and new york; local inflation; exchange rate of local currency relative to the usd; and average expenditure pattern of staff members currently at a given location. the multiplier is adjusted periodically to reflect changes in the cost of living in a given city. we used the multiplier from the march update. all cost information was converted into us dollars using the icsc conversion factor (march update) to make international comparisons possible. our analysis has several limitations. first, although we did an extensive search, it is possible we missed a few degree programmes. our search was limited to schools which were explicitly master's of global or international health rather than master's programmes with an option of a global health concentration. future iterations of this analysis could include other types of global health degrees (eg, master's of public health with a global health concentration). second, while efforts were made to contact each school if the tuition was not clearly listed on their webpage, it is possible that errors were made when calculating the tuition for fluctuating fees (eg, based on number of credits where the per-credit fee changes each year). for programmes which did not have a fixed total fee, it was difficult to gauge exactly how much a degree would cost in its entirety and despite seeking clarification, many schools could not give an exact number. in addition, while tuition was calculated based on the fees posted on a school's website in march , fees may have changed for the fall cohort. there was a lack of transparency both on the websites themselves and after contacting the universities. in addition, many programmes were reluctant to disclose the exact duration of a degree, since the duration depended largely on the profile of the incoming trainee and how quickly they could meet programme requirements. third, we used a simplistic marker for cost for living established by the un. while it would have been ideal to have gathered information of the average cost of living for a typical student in any given year, this information was not usually available for most schools, with some exceptions. fourth, we could not get data on diversity of the students who are in these global health degree programmes. thus, we do not know what proportion of the student body is made up of high-income country versus lmic trainees. lastly, we also do not have data on how many lmic trainees receive tuitionfee waivers or scholarships to complete global health degrees. also shows that many schools charge the same amount to domestic and international students (with the exception of western pacific and nordic schools), and that there is a wide dispersion in costs of tuition by region. despite limitations (see box ), we can make some key inferences from this analysis. the data presented suggest that there may be a disconnect between where global health training is needed most versus where the degree programmes are currently offered. it would thus be useful to apply the health labour market framework to better understand this discrepancy between demand and supply and the mechanisms behind this apparent divide. one potential explanation for this disconnect is that the idea of 'global health training' is itself an hic phenomenon; much of what is taught in such programmes in hics are likely typically covered in mph and related programmes (eg, community health) in lmics. another explanation, which we discuss later, is that global health degrees are a revenue-generating activity for the universities, which seek to take advantage of growing student interest in global health. tuition fees are high for most programmes. these costs will be even higher if we added costs beyond tuition (eg, travel, living expenses, accommodation, health insurance and summer practicum). without substantial external support, these degrees, we believe, would be unaffordable to trainees in lmics. additional research is needed to calculate fully loaded costs for global health degrees. this would vary a lot, depending on the country and cost of living and what financial aid or fellowships to this extent, we hope global health degree programmes will be transparent about diversity in their student body and provide information on what proportion of their lmic students receive tuition waivers or fellowships. we need data on diversity among global health students. we also need data on what proportion of the lmic students in these degrees get full tuition fee waivers. we know almost all schools offer such fee waivers, but cannot provide data on how many. this could be a topic of future research. tracking and improving this could help enhance reciprocity in global health. if students are paying high fees to get global health degrees, it is unclear what their job prospects are after completing such degrees. to recover the costs, they would need to find high-paying jobs (which might not be in the field of global health) and/or work in hics. we need to further study whether and to what extent global health degrees actually help build global health capacity and address the massive healthcare workforce shortage in lmics. in making the decision on fee waiver, another consideration should be the provenance of global health knowledge. the cost of global health training programmes for lmic students should reflect the fact that lmics are the origin of much of the knowledge that gets shared (or should ideally be shared) in hic global health training programmes. this is one of many reasons why lmic candidates should, as a matter of fairness, receive fee waivers. fee waivers may also represent a form of reparation, given the colonial and extractive origins of many hic universities and global/ public health schools. based on where global health degrees are offered and the high fees charged, we infer that most degrees might be catering to hic students and students from elite and privileged backgrounds in lmics, thus privileging a student group that is already privileged. the current leaders of global health organisations are drawn from this same limited pool. the pattern of global health training serves to perpetuate lack of diversity, a huge problem in global health that risks perpetuating colonial approaches and structures. if global health schools in hics truly care about making global health training accessible to lmics and believe in equity and reciprocity, then we should expect to see tiered tuition fee structures. we found that most schools, especially those in the usa, charge the same for domestic and international students, suggesting a lack of lower and affordable pricing for lmic trainees. this may be because the degree programmes are meant to generate revenues and be 'self-supporting' or 'self-financing.' but this explanation also suggests that, contrary to using global health degrees to enhance equity and reciprocity, many hic universities, especially medical schools, (including private universities with billions in endowments) apparently see global health training as a mechanism to generate revenue. to democratise global health education and improve equity, fairness and reciprocity, hic universities can and must allocate a certain proportion of their slots for lmic students, offer full funding support (including accommodation), and support with travel and visas. the fogarty international center training programmes by the us national institutes of health (nih) is a good model for all hics to replicate, as it has helped train over scientists worldwide, spending a small fraction of the overall nih budget. we are not surprised that there are few degree programmes in global health in lmics, since nationals of lmics do not see their day-to-day public health or clinical work as 'global health.' but we are puzzled as to why the few degree programmes based in asia and africa are priced so high. so, even within lmics, these degree programmes may be serving the privileged and elite. while these schools have indicated that they offer scholarships to candidates from lmics it is unclear how much funding is given to each student and how many students are granted these awards. this transparency would be useful. because of the covid- pandemic, more global health degrees might move to remote or distance education. it is disappointing that distance education global health degrees still cost about us$ for international students. if tuition fees were more affordable for lmic trainees, then thousands of students can be trained. but beyond affordability, there are other major barriers for lmic trainees, including the struggle to get visas to enter countries such as the usa and uk, especially with brexit and us visa bans. by working with lmic experts to create affordable, quality, online training programmes for lmic students, hic universities can demonstrate that they can deliver on reciprocity and equity. in conclusion, even if hic universities made their degrees more accessible, we should still ask why an african trainee must go to london or boston to learn about control of sleeping sickness or malaria (and pay top dollars for such training)? the traditional mindset in global health that expertise flows from north to south, is reflected in research, training, consultancy and technical assistance. this colonial model is ripe for disruption. building top-notch institutions in lmics is critical, to reduce dependence on hics, and to improve the overall quality, depth and relevance of global health training and research. someday, we hope hic trainees will earn global health degrees from such lmic universities, and learn directly from experts who are closest to the problems and closest to the solution. twitter seye abimbola @seyeabimbola and madhukar pai @paimadhu acknowledgements we are grateful to all the universities that responded to our request for information about their degree programmes in global health. errors, if any, are our own. contributors mp and sa conceived the study. as and nav collected and verified the data. as and mp wrote the initial draft. all authors revised and approved the final version. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. disclaimer the depiction of boundaries on this map does not imply the expression of any opinion whatsoever on the part of bmj (or any member of its group) concerning the legal status of any country, territory, jurisdiction or area or of its authorities. this map is provided without any warranty of any kind, either express or implied. competing interests mp is on the editorial board of bmj global health. sa is editor-in-chief of bmj global health. they are from india and nigeria, respectively, but had the privilege of training in hic universities. they are currently based in hic universities, and are aware of their obligation to address the inequities discussed in this paper. patient consent for publication not required. provenance and peer review not commissioned; internally peer reviewed. towards a common definition of global health global health research needs more than a makeover on the meaning of global health and the role of global health journals global health needs to be global & diverse. usa: forbes global health / . the global health / report : power, privilege and priorities the foreign gaze: authorship in academic global health stuck in the middle: a systematic review of authorship in collaborative health research in africa who is telling the story? a systematic review of authorship for infectious disease research conducted in africa diversity in the editorial boards of global health journals global health journals need to address equity, diversity and inclusion consortium of universities for global health world health organization. the labour market for human resources for health in low-and middle-income countries a comprehensive health labour market framework for universal health coverage offline: the case against global health teaching global health from the south: challenges and proposals reciprocity in global health: here is how we can do better. forbes. usa: forbes on the coloniality of global public heath ebola and the narrative of mistrust global health still mimics colonial ways: here's how to break the pattern our role in global health. bethesda: national institutes of health the lancet global h. passports and privilege: access denied international civil service commission. the post adjustment index key: cord- -ovfqfurf authors: memish, ziad a; stephens, gwen m; steffen, robert; ahmed, qanta a title: emergence of medicine for mass gatherings: lessons from the hajj date: - - journal: lancet infect dis doi: . /s - ( ) - sha: doc_id: cord_uid: ovfqfurf although definitions of mass gatherings (mg) vary greatly, they consist of large numbers of people attending an event at a specific site for a finite time. examples of mgs include world youth day, the summer and winter olympics, rock concerts, and political rallies. some of the largest mgs are spiritual in nature. among all mgs, the public health issues, associated with the hajj (an annual pilgrimage to mecca, saudi arabia) is clearly the best reported—probably because of its international or even intercontinental implications in terms of the spread of infectious disease. hajj routinely attracts · million muslims for worship. who's global health initiatives have converged with saudi arabia's efforts to ensure the wellbeing of pilgrims, contain infectious diseases, and reinforce global health security through the management of the hajj. both initiatives emphasise the importance of mg health policies guided by sound evidence and based on experience and the timeliness of calls for a new academic science-based specialty of mg medicine. defi nitions of mass gatherings (mgs) vary greatly, with some sources specifying any gathering to be an mg when more than individuals attend, whereas others require the attendance of as many as people to qualify. , irrespective of the defi nition, mgs represent large numbers of people attending an event that is focused at specifi c sites for a fi nite time. these gatherings might be planned or unplanned and recurrent or sporadic. examples of mgs include world youth day, the summer and winter olympics, rock concerts, and political rallies. mgs pose many challenges, such as crowd management, security, and emergency preparedness. stampedes and crush injuries are common, the result of inevitable crowding. outdoor events are associated with complications of exposure, dehydration, sunburn, and heat exhaustion. other health hazards arise from lack of food hygiene, inadequate waste management, and poor sanitation. violence is unpredictable and diffi cult to mitigate whether the mg is a political rally or a sporting competition. with few exceptions, however, the rates of morbidity and mortality resulting from these hazards are rarely increased outside the event. global mgs, however, can lead to global hazards. mitigation of risks requires expertise outside the specialty of acute care medicine, event planning, and venue engineering. for centuries, muslim pilgrims have converged in mecca, saudi arabia, for the hajj (fi gure ) to participate in a series of sacred rituals that defi ne islam. with about · billion muslims and the obligation on believers to attend hajj at least once in their lifetimes, this event has become the largest annually recurring mg in the world, with attendance reaching more than · million in despite warnings about pandemic infl uenza. pilgrims come from more than countries, leading to enormous diversity in terms of ethnic origin and socioeconomic status. men, women, and children of all ages attend hajj together; however, a disproportionate number of people will be middle aged or older before they can aff ord the journey. comorbidities are common. the public health implications of the hajj are huge-nearly pilgrims arrive from low-income countries, many will have had little, if any, pre-hajj health care, added to which are the saudi arabia's safety and security policies for hajj attendees are well developed after decades of planning the annual event. lessons learned have led to comprehensive programmes that are continually revised and coordinated by government sectors. public health has involved global partners for decades. far from being the only mg that aff ects global health, the hajj is a useful model to understand the nature of risk management and the benefi ts of international collaboration and cooperation. pilgrimage is central to many belief systems and also appeals to mankind's recurring desire to be homo viator-a universal fi gure common to many cultures and civilisations, who wanders in search of spiritual enlightenment. in hellenic civilisation, delphi-home to pythia the oracle-was long a focus for pilgrimage. ancient tribal populations such as the huichol of western mexico, the lunda of central africa, and the shona people of southwest africa all included pilgrimage in their cultures. institutionalised pilgrimage came to prominence with the advent of world religions. buddhism invites pilgrimage to nepal, the birthplace of siddharta. hindus journey to benares in india, and followers of judaism to jerusalem. christendom has a complex history of pilgrimages through the ages including the modern era. until the advent of modern air travel, the journey was associated with the greatest risks. a review of the historical data for the hajj shows these dangers: "…the oscillatory movement of the camel produces miscarriages, followed frequently by haemorrhage and death of the infant and mother. the caravan however cannot stop, and it is impossible to nurse effi ciently while the (journey) continues. if any portion of the caravan stopped it would certainly be attacked…" kumbh mela is a huge hindu pilgrimage held at various locations along the river ganges according to the zodiac positions of the sun, moon, and jupiter. purifi cation rites involve bathing in the ganges and are believed to interrupt the cycle of reincarnation. the highest holy days arise every years, but the normal kumbh mela is celebrated every years, and often attract thousands of non-hindu enthusiasts. this is the largest human gathering, so large that in movements of the amassed individuals could be seen from space. , the ardh kumbh mela in attracted million pilgrims over days in allahabad; on the most auspicious day of the festival, more than million participated. celebrations are accompanied by singing, religious readings, and ritual feeding of holy men and the poor. managing rival sects is a recurring challenge. administrators overseeing the event have to negotiate bathing schedules. clashes have resulted in deaths-eg, in , a vehicle carrying members of the juna sect struck several people, setting off a stampede. in , a stampede killed people. the festival probably contributed to the - asiatic cholera pandemic. pilgrims are believed to have carried the bacteria from an endemic area in the lower ganges to populations in the upper ganges, from there to kolkata and mumbai, and across the subcontinent. british soldiers and sailors took it home to europe and then to the far east. the epidemic ended abruptly in after a very cold winter. although cholera returned to the kumbh mela in , authorities of the hardiwar improvement society reacted to contain the outbreak. diarrhoeal diseases, including cholera, continue to be a risk at the gathering despite rapid monitoring and prompt public health interventions. another pilgrimage with a focus on water and religious rites is to lourdes, france. this village in the pyrenees attracts more than million catholics and other enthusiasts every year. their destination is a shrine and nearby spring where a young village girl witnessed apparitions of the virgin mary in the mid s. drinking and bathing in lourdes' water is believed to ensure health and cure disease, and is featured at the water walk where religious stations are situated and water is available for drinking or bottling. spring water is also routed to a series of bathing stalls used by more than pilgrims every year. although health issues have not been associated with lourdes' waters, the french writer emile zola visited the spring in and provided a graphic description of the baths at the time: "and the water was not exactly inviting. the grotto fathers were afraid that the output of the spring would be insuffi cient, so in those days they had the water in the pools changed just twice a day. as some hundred patients passed through the same water, you can imagine what a horrible slop it was at the end. there was everything in it: threads of blood, sloughed-off skin, scabs, bits of cloth and bandage, an abominable soup of ills...the miracle was that anyone emerged alive from this human slime." stampedes and fi res continue to be major causes of death and injury at mgs-eg, the sabarimala in kerala, india, and the feast of the black nazarene in manila, philippines. inaccessible for years after their construction, hindu temples of sabarimala in kerala's western ghat mountains have become increasingly popular despite the location and winter openings. with the increasing crowd sizes, tragedies have occurred. in , pilgrims burned to death when sheds containing fi reworks caught fi re, and more than perished in when a hillside collapsed under the weight of assembled worshipers triggering a stampede. more than million attended the most recent rites in series january, , uneventful until the last day when a motor vehicle accident caused a panic that triggered a stampede, killing people. , although authorities off ered compensation packages, they could not quell unprecedented public criticism of kerala authorities and the national government. manila's feast of the black nazarene has fared a little better after religious leaders and municipal authorities joined forces to change the route of the annual jan procession after two deaths in , and many stampedes and injuries caused by fi reworks and trauma over the years. the authorities responsible for the mg also recruited thousands of volunteers to manage the crowds. these changes and the addition of an information campaign have helped calm crowds and reduce injuries. despite an estimated attendance of - million in , no deaths or serious injuries were reported. protests during the arab spring in drew millions of largely peaceful protesters to central locations of tunis, tunisia, and then cairo, egypt. more than million were present when the departure of egypt's president hosni mubarak was announced in february, . other mgs include political protests of the antiwar movement during the vietnam war. was marked by massive student marches in major european, asian, and latin american capitals. chicago, il, usa, had a particularly violent succession of mgs that became riots after the assassination of the civil rights leader martin luther king and again a few months later during antiwar protests at the democratic national convention. by contrast, european marches in protest of the us-led invasion of iraq were larger and more peaceful. more than million attended the largest march in rome in (fi gure ). in , antiglobalisation protesters assembled in seattle, wa, usa, ahead of a scheduled world trade organization meeting. along with international anticorporate interests and assorted domestic supporters, they successfully occupied seattle's downtown core and the convention centre. violence increased during the days, culminating in a full-scale riot after anarchists joined in and police responded with tear gas and rubber bullets. the battle in seattle as it came to be known, caused damages that were estimated at more than us$ billion. despite the violence and very large crowds, estimated to be hundreds of , violent sports fans are as old as history. in , the nika riots in constantinople pitted rival charioteer factions and athletes against each other and emperor justinian. during the month insurrection that ensued, half the city was destroyed and more than people died. although sports violence continues to be a risk during matches between rival teams, the massive crowds, crowds in motion, and immovable barriers cause the greatest loss of lives. the worst sports riot in history occurred in south america during a football playoff game between peru and argentina when fans responded in protest after a controversial decision to annul a goal by peru. police responded by throwing teargas canisters into the grandstand. more than fans were injured and another died. most were crushed trying to escape the locked stadium, others died from teargas asphyxiation. the disaster in hillsborough, uk, in was the worst stadium tragedy in british history. fans died and another were injured as crowds surged into the stadium crushing others in front who were pinned against fences. many of the deaths resulted from compressive asphyxia while standing. ineff ective crowd control and poorly designed venues have also resulted in deaths at music festivals, most recently in during the love parade in duisburg, germany, in which people were crushed to death and were injured as a result of a stampede in a narrow tunnel. occasionally, mgs cause structural stresses that threaten safety and security. in , the th anniversary of the golden gate bridge, san francisco, ca, usa, was celebrated by closing it to vehicular traffi c. though not catastrophic, the suspension cables had the greatest load factor ever when pedestrians crowded onto the deck, fl attening its centre span. although the hajj was undertaken in the middle east before the arrival of islam, the movements and rituals of pilgrims today have not changed since the prophet mohammad inaugurated the islamic hajj in his lifetime. it has been recorded in arabic literature known as adab al rihla. persian literature records hajj in the safarnameh (travel letter). at the core of islamic belief is trust and this trust has been best exemplifi ed by the risks muslims take when travelling. the muslim individual must trust in his maker and, in ancient times, in the benevolence of strangers who would host him on his perilous journey to mecca. nowadays, as a result of the dissemination of islam across the world, hajj removes national, cultural, and social boundaries between diverse people like no other event. hajj has been the focus of public health initiatives for centuries, as shown in contemporary medical reports. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] during the th century, the hajj attracted the interest of european powers, particularly the maritime travel to the hajj, which dominated until the arrival of air travel. colonial powers at the time were suspicious of political islam, which was referred to as wahabism. direct engagement in hajj-related aff airs was seen as too intrusive by politically savvy imperialists who recognised the sanctity of this little understood religious pilgrimage. instead, supervision, albeit series displaced, and management of hajj were gradual processes, including surveillance, regulation, secure passage through the red sea and protection of british littoral interests, and eventually formal organisational processes, which would quickly become central to these hidden concerns. imperial organisations linked cholera morbus, a non-epidemic diarrhoea, to hajj, allowing a public health industry to develop that used health concerns to control immigration, pilgrim passports, proof of suffi cient funds to allow return travel, maritime regulation, and vessel quarantine procedures. by the mid th century, most of the muslim populations using maritime travel for hajj were from the malay peninsula and indian subcontinent. about pilgrims travelled from the malay peninsula and between and arrived from the indian subcontinent. although there are few reliable data, the total number of pilgrims was estimated to be . "according to the turko-egyptian sanitary commissioners at mecca, the number of mohammedan pilgrims collected in and about the holy city…amounted to two hundred thousand persons; composed of natives of turkey, india, egypt, morocco, arabia, syria, persia, java etc." most travellers came in small vessels of - tons under diff erent international aegis. departures were concentrated around singapore, calcutta and madras in india, aceh in indonesia, and other regional cities. most pilgrims then, like today, disembarked in jeddah, though some would land on southern arabian coastal ports and then make a land journey through yemen to hijaz. well into the th century, the conditions of passage were often appallingly cramped and unsanitary. many people died along the route from infection and dehydration. pilgrims died on board a maritime vessel, which had embarked from jeddah with pilgrims en route home to singapore. "when she drew abreast of the watcher she proved to be a pilgrim ship; the afternoon being hot, the travellers had all crowded to the port side to catch what little wind was stirring. their numbers were so great that they appeared to cover all the deck space, while the ship was unable to right herself from the list…" eff orts to manage hajj were initiated by dutch-indonesian authorities, not for wholly altruistic reasons. the dutch had established an association between returning pilgrims and societal unrest, so they introduced heavily surcharged passports as a way of restricting the number of travellers to mecca. the ruling empires focused on health issues and justifi ed inspections of hajj sites for compliance with contemporary public health directives, often focusing on quarantine as a means of protection at a time when many international arrivals, including maritime travellers, were reaching mecca. their inspections were disappointing-the annual sanitary commission visited the sites of hajj and noted that the focus was not on prevention, but rather on the easy option of quarantine. when cholera was reported at hagar's well within the holy mosque in mecca, the british consul at jeddah requested a scientifi c assessment. samples were analysed at the royal college of chemistry in the south kensington museum, london, uk, and compared with those of london sewage, which was a source of cholera at that time. recommendations after their alarming fi ndings were sent to the secretary of state for india who reported the well to be infected with the bacterium. , similarly, entrepôt cholérique (cholera reservoir) was noted when authorities visited pilgrims from india intending to do the hajj. these pilgrims were routinely detained on the island of camaran as a quarantine station in the red sea to restrict the ingress of cholera into the holy sites. , pilgrims were detained for - days without adequate provisions or clean water. the long exposure to sun, however, was thought to be benefi cial for elimination of infection. after quarantine, pilgrims were often permitted into the site. results of later studies showed a link between the pilgrims quarantined on camaran with a series of eight subsequent outbreaks. the conclusions drawn from a review of these events at an international public health meeting at the international sanitary conference of paris, france, , were that the "turkish possession of camaran remains the greatest hindrance to the abolition of cholera at mecca". infection was a frequent feature of the hajj in the th and th centuries, not unexpected since infectious disease medicine became better elucidated and the fascination with the developing specialty increased. epidemics of smallpox occurred in iraq and sudan between october, , and april, . a small epidemic of plague occurred pamela das www.thelancet.com/infection vol january series in upper egypt and a larger one in morocco ( cases). cases of typhus were reported in egypt and in palestine during the same period. these fi ndings led to some strong recommendations that are still relevant: "the yearly pilgrimage will remain a danger to all the countries from which pilgrims are drawn as long as the conditions of transport and accommodation remain…as at present. effi cient reorganization of the pilgrimage in every direction is needed and should be facilitated by the governments of the large number of the countries involved." by the early th century, non-muslim european powers were heavily engaged in the management of the hajj and would remain so until modern saudi arabia came into existence and acquired fi nancial independence through petrochemical wealth. the comparison of hajj in the imperial era with the modern hajj shows the absence of muslim public health experts or authorities in managing this pilgrimage. , this absence would gradually change and with the arrival of ibn saud's modern kingdom and its investments in hajj. from this point, muslims would solely administer the modern hajj in its entirety. , the islamic calendar is a lunar calendar, so the date of the hajj moves forward by - days every year, presenting planners with additional challenges of health risks that are associated with seasonal variation. temperature fl uctuations in mecca might be extreme depending on the time of year; daytime highs can be °c and higher, and night-time temperatures occasionally fall to °c. hajj can coincide with the northern hemisphere's infl uenza season, as in , increasing public health risks. [ ] [ ] [ ] [ ] [ ] attendance in was not blunted despite offi cial recommendations encouraging pregnant women, and elderly and very young people to stay at home. more than · million people attended, including · million foreign citizens, of whom did not have valid hajj permits. to put the event in its local context, the infl ux of pilgrims is so great that it trebles the resident population of mecca, which is normally · million. access to the hajj for pilgrims has changed greatly with air travel gradually replacing maritime and overland travel. in the past decade, the breakdown includes about % of pilgrims arriving by air, % making the maritime journey, and % travelling over land. although a few pilgrims will arrive at medina's international airport, jeddah remains the major port of entry for all travellers as it has been for centuries. increasing numbers of people attending the modern hajj led to a decision by saudi aviation authorities to partition jeddah's king abdulaziz international airport and create a separate south terminal to serve all pilgrims. now two-thirds completed, the terminal's capacity is travellers at any time. when completed, its fi nal capacity will be greater than million passengers per year. important new features include health-screening systems, customs, and immigrations security. each of its hubs receives pilgrim fl ights; all hubs have two examination rooms. the terminal also features large holding areas that allow effi cient reviews of selected arrivals in segregated parts of the terminal. this permits verifi cation of the immunisation status and administration of any prophylactic drugs and vaccines according to set protocols. the overall design of the terminal permits visitors arriving without required visas and health records to be managed outside the main fl ow of pilgrims who continue through the facility to join assigned groups or agents who are responsible for coordinating details of travel and housing. these regulated services will also escort their charges through the hajj site. in islam, umrah is a shorter pilgrimage to mecca. although not compulsory, umrah draws an additional million pilgrims per year to the country; jeddah's airport plays a major part throughout the year, controlling access and enforcing health protocols. groups exiting the country and returning home are also monitored, allowing comparative studies between the two populations. at various times of the year, but most intensely during the hajj season, public health teams, both stationary and mobile, use mobile devices to monitor inbound and outbound populations. protocols are based on regularly reviewed case defi nitions. gathered data are sent to centralised databases for real-time analysis. many diseases are monitored during a hajj season. those given specifi c attention every year include both mild and severe respiratory diseases, food poisoning and gastroenteritis syndromes, haemorrhagic fevers, and meningococcal diseases. reports of all diseases, but particularly those with immediate eff ect worldwidesevere acute respiratory syndrome (sars), infl uenza, cholera, yellow fever, polio, plague, meningitis, and viral haemorrhagic syndromes-are expedited to who epidemiologists who work closely with saudi authorities reuters/jim young series to analyse information and coordinate a response. the airport is also equipped with clinics for management of medical problems. humility, faith, and unity are emphasised throughout the hajj. the pilgrims wear simple clothing, women and men comingle, women are enjoined not to cover their faces, children and adults of all ages are included, and families journey together. on arrival in mecca, hajj pilgrims do a series of synchronised acts based on events in the lives of ibrahim (abraham), his wife hajra (hagar), and their son ishmael. each pilgrim does an initial circumambulation (tawaf ) around the central ka'aba seven times. when completed, the pilgrim leaves for arafat, about km east of mecca. hajj culminates in arafat on the day of standing, when all · - · million visitors stand and supplicate together on the mountain. mount arafat is believed to be the site of mohammad's last sermon to his followers. many people attempt to pray at the summit believing prayers there are the most blessed. on the way to arafat, the pilgrims make overnight stops for prayers and contemplation in mina. leaving arafat, the pilgrims return to muzdaliff ah, where stones are gathered; on the way to mina, they stop at jamarat bridge to throw stones at the pillars that are effi gies of satan. when the pilgrimage is complete, the new hajjee (pilgrim who has completed the hajj) makes an animal sacrifi ce thanking allah for accepting his hajj. this is often a proxy sacrifi ce because the saudi government has established modern abattoirs that are staff ed by professionals who will do this on behalf of the pilgrims. meat is then distributed to the poor, family, and friends. the fi nal farewell is undertaken with another seven circuits around the ka'aba. muslim men on completion of a successful hajj shave their heads. after completion of the hajj, most pilgrims exit the country at jeddah airport, which has congestion so great that the telecommunications infrastructure has to be constantly updated to allow suffi cient capacity. a smaller number of pilgrims will visit the holy mosque in medina. some will also visit tourist sites in the hijaz and the old city of jeddah. because all hajj pilgrims travel as part of small informal groups, there is order in what could otherwise be chaos. groups take their shepherding of individual pilgrims seriously, with easily identifi ed group leaders who carry placards and fl ags and lead the entire group through the rituals without losing stragglers, infi rm individuals, or temporarily distracted people. further, this fl exibility safeguards hajj at the most pressured points, which could otherwise become treacherous. despite this fl exibility, hajj stampedes have been recurring events, most notably at the jamarat site. according to islam, only adults should undertake the hajj. the age at which hajj is undertaken varies according to culture. some nationalities seem to undertake hajj at a uniformly young age (eg, indonesian and malaysian), whereas other nationalities defer hajj until the late phase of life as a precursor to preparing for death. there might also be diff erences in sex distribution. malaysia for instance has had a female dominated hajj attendance for more than three decades. in keeping with the islamic spirit of compassion, muslims are enjoined to undertake hajj only when adequately healthy. despite this strong scriptural admonition, many muslims insist on hajj even when wheelchair bound. special accommodations for wheelchairs are provided at the holy mosque despite the tremendous crowd densities. these channels are wide enough to admit wheelchairs and one person pushing the wheelchair and are divided into two lanes (one for each direction). pilgrims who are not well are provided transport by the ministry of health ambulance to hajj sites as needed so they can complete their pilgrimage. because of the islamic belief that death during the hajj has a benefi cial outcome in the afterlife, a few sick pilgrims attend, hoping for death during the hajj. public health and religious offi cials do much to dissuade this belief, which is often tenacious. this cultural belief system aff ects care providers at hajj, all of whom are muslims (non-muslims are not permitted to enter the holy sites). anecdotally, this belief aff ects resuscitation eff orts of those in cardiac arrest, which once initiated (if the patient reaches the emergency rescue services in time) are unlikely to be pursued if not immediately successful. a do-not-resuscitate status is often requested by pilgrims who can speak for themselves. hajj itself has several qualities that aid public health security. attendees must practise specifi c behaviours for their hajj to be considered valid, and these requirements are strict and closely adhered to by both clerical and community leaders. crime is strictly forbidden at hajj and the risk of violent altercation is reduced because of the weapon-free, drug-free, and alcohol-free environment. tobacco intake is also banned, curtailing the risk of inadvertent fi re hazards. by contrast with some other mgs, sexual relations are not allowed during hajj and male and female pilgrims are accommodated separately even when travelling as families, eliminating the risk of sexually transmitted disease. this observant, penitent, and sober crowd engrossed in worship is thus likely to remain cooperative and coherent if sudden events demand rapid cooperation with authorities. insurrection, rioting, disinhibited behaviour, or hooliganism of any kind does not arise even in these extraordinarily massive crowds. pilgrims are urged to safeguard themselves or others at all times, aiding the infi rm and assisting the fallen, behaviours that symbolise peaceful islamic societies that enhance the public health security. the spirit of cooperation is central to a successful series acceptance of the hajj by allah in the islamic belief system and reduces the potential risk of disastrous events in such massive crowds. saudi arabia's responsibility for the hajj has aff ected the country's advanced health-care infrastructure and its multinational approach to public health. although other jurisdictions have administered the hajj, saudi arabia has invested in it. within the immediate vicinity of the hajj, there are primary health-care centres and hospitals with a total capacity of beds including beds for critical care. the latest emergency management medical systems were installed in healthcare centres and staff ed with specialised personnel. more than doctors and nurses provide services, all at no charge. this event requires the planning and coordination of all government sectors; as one hajj ends, planning for the next begins. infection and prevention strategies are reviewed, assessed, and revised every year. coordination and planning requires the eff orts of supervising committees, all reporting to the minister of health. the preventive medicine committee oversees all key public health and preventive matters during the hajj and supervises staff working at all ports of entry. public health teams distributed throughout the hajj site are the operational eyes and ears of the policy planners. in hosting the modern hajj, saudi arabia has weathered a th century world war, global outbreaks due to newly emerging disease (including sars and meningococcal meningitis w ), and regional confl icts. in this time, the country has acquired a unique, resilient expertise concerning hajj-related public health. important observations that are relevant to public health planners everywhere are part of this experience. one of the best examples of such cross-cultural translation has been in the preparation for barack obama's presidential inauguration and crowd management informed by the hajj experience. yet the process of exchanging expertise is possibly even more instructive. collaborative work on this scale shows the increasingly important global health diplomacy in which the muslim world has an enormous part to play. first articulated by the us health and human services secretary tommy thompson, global health diplomacy usually includes the provision of a service by one nation to another. the usa's rebuilding of maternity hospitals in afghanistan or the deployment of the ship uss comfort to serve as a site for temporary clinics in vietnamese coastal waters are two recent examples. as they struggled with the best responses to the global threat of pandemic infl uenza a h n , which coincided with the hajj in , colleagues at the us centers for disease control and prevention and the saudi ministry of health worked together to deploy one of the largest real-time mobile databasing systems, which was designed to detect disease in real time at any mg. senator john kerry discussed precisely this joint eff ort in a speech in doha at the us-islamic world forum. , this international collaboration was realised only through both intense personal dedication and the confi dence the agencies had in their people. such collaboration strongly resonates with president obama's renewed hopes for us engagement with the muslim world, as articulated in his speech in cairo, egypt, in june, . people who collaborate, write, and disseminate information internationally have long been aware of the latent value of such informal, positive exchange. in the fl at world of medical academia, individuals have immediate and palpable eff ects. fostering such professional dialogues are everyday (albeit unseen) acts of global health diplomacy. when investigators and physicians work in a shared space, unfettered by the global geopolitics, global health diplomacy becomes alive and vibrant. hajj medicine, as part of the emerging specialty of mg medicine, provides an extraordinary platform. saudi arabia's experience in international service through public health is substantial and is promoting the emergence of the formalised specialty of mg medicine. hajj continues to provide insights into advanced and complex public health challenges, which are unlocked through collaborative exchange. disease and suff ering remain universal, even in the st century. solving these challenges is relevant to humanity everywhere. islamic scholars have long referred to hajj as a metaphor for ideal societal behaviour. at the centre of these ideals is a unifying theme: collaboration. saudi arabia's experience of hajj medicine contains rapidly developing public health solutions to several global challenges. multiagency and multinational approaches to public health challenges are likely to become major factors in the specialty of global health diplomacy, engaging societies globally, and drawing the west a little closer to the east. in view of the global public health threats that might originate from mgs, medicine relevant to mgs has become an essential specialised, interdisciplinary branch of public health, particularly hybridised with global health response, travel medicine, and emergency or disaster planning. agencies outside the realm of public health should be closely involved in mg medicine. in the operation and management of an mg, several sectorshealth care, security, and public communications-need to know how to interface with public health services and resources quickly and eff ectively. involving public health experts with the broader civic planning for any mg helps with parallel transparency in needs and expectations, ensuring that public health considerations are factored into the entire planning process instead of intruding too late in development, relegating public health security series concerns to little more than ineff ective afterthought. delayed entry of these actors into the planning process can debilitate or completely disable adequate responses to potential diseases during mgs. experts must educate civic planners about the values of early collaborative approaches to mgs for these reasons. conventional concepts of disease and crowd control do not adequately address the complexity of mgs. the need for mg health policies that are guided by sound evidence but anchored in experience shows the importance of calls for a new academic medical and science-based discipline. mgs have been associated with death and destructioncatastrophic stampedes, collapse of venues, crowd violence, and damage to political and commercial infrastructure, but little is known about the threats from mgs to the global health security. who has worked closely with international agencies to address such risks. [ ] [ ] [ ] mgs pose complex challenges that require a broad expertise and saudi arabia has the experience and infrastructure to provide unique expertise with respect to mgs. zam and gms co-wrote the text. imperial powers and th century hajj, hajj culture, and most of the global health diplomacy sections were contributed by qaa. rs compiled the table. we declare that we have no confl icts of interests. we identifi ed references for this review by searching medline and the national health service hospital search service for articles published in english from to august, . additional articles were identifi ed through searches of extensive fi les belonging to the authors. search terms used were "mass gathering", "disease", "pilgrimage", "hajj", "outbreak", "public health", "prevention", "travel", or "modeling". we reviewed the articles found during these searches and relevant references cited in the articles. mass gathering medicine: a predictive model for patient presentation and transport rates mass gathering medical care: a twenty-fi ve year review from medieval pilgrimage to religious tourism: the social and cultural economics of piety the lancet. a mohamedan doctor on the mecca pilgrimage kumbh mela pictured from space millions of hindus wash away their sins five die in stampede at hindu bathing festival what is hinduism?: modern adventures into a profound global faith epidemics and pandemics: their impacts on human history use of telemedicine in evading cholera outbreak in mahakumbh mela the baths lourdes: body and spirit in the secular age another black friday for sabarimala pilgrims sabarimala stampede death toll crosses sabarimala stampede, injured list of largest peaceful gatherings in history promed mail. varicella, asian games-qatar ex maldives centennial olympic park bombing summer olympics procopius: justinian suppresses the nika revolt muhammad: a biography of the prophet return pilgrims from mecca. egyptian quarantine at torr. (from a correspondent) the pilgrimage to mecca: medical care of pilgrims from the sudan the lancet. the origin of cholera in mecca cholera at mecca and quarantine in egypt the lancet. the risks of the mecca pilgrimage the lancet. the mecca pilgrimage the cholera and hagar's well at mecca hagar's well at mecca camaran: the cause of cholera to mecca pilgrims sanitation and security: the imperial powers and the nineteenth century hajj mecca pilgrimage quarantine and the mecca pilgrimage-the growth of an idea the lancet. a medico-sanitary pilgrimage to mecca the lancet. the pilgrimage to mecca guests of god pilgrimage and politics in the islamic world pandemic h n infl uenza at the hajj: understanding the unexpectedly low h n burden global public health implications of a mass gathering in mecca, saudi arabia during the midst of an infl uenza pandemic infl uenza a (h n ) in the kingdom of saudi arabia: description of the fi rst one hundred cases and the jeddah hajj consultancy group. establishment of public health security in saudi arabia for the hajj in response to pandemic infl uenza a h n pandemic h n and the hajj health conditions for travellers to saudi arabia for the pilgrimage to mecca (hajj) royal embassy of saudi arabia. , , million pilgrims participated in hajj global public health implications of a mass gathering in mecca, saudi arabia during the midst of an infl uenza pandemic emergency room to the intensive care unit in hajj. the chain of life the quest for public health security at hajj: the who guidelines on communicable disease alert and response during mass gatherings citation?related-urls=yes&-legid=healthaff remarks by the president on a new beginning. www.whitehouse. gov/the_press_offi ce/remarks-by-the-president-at-cairo-university- - - chairman kerry addresses the us-islamic world forum jeddah declaration on mass gatherings health international health regulations who. communicable disease alert and response for mass gatherings: key considerations we thank abdullah a al rabeeah, the saudi minister of health, for his leadership and support for hosting the lancet conference on mg medicine: implications and opportunities for global health security, jeddah, saudi arabia, oct - , , which generated the series of reviews. key: cord- -hmzwhrpi authors: meade, cathy d.; stanley, nathanael b.; martinez-tyson, dinorah; gwede, clement k. title: years later: continued relevance of cancer, culture, and literacy in cancer education for social justice and health equity date: - - journal: j cancer educ doi: . /s - - -y sha: doc_id: cord_uid: hmzwhrpi nan the persistence of health disparities is no longer a novel observation, but a well-documented reality whereby many populations have markedly unrelenting poorer levels of health. inequities are influenced by complex historical and contemporary relationships between health and biology, and further affected by racism, discrimination, socioeconomic status, physical environment, literacy, and sexual orientation/gender identity to name a few [ , ] . recognition of such factors is essential for a norm of inclusion for achieving health equity [ ] . as society globalizes through technological innovations and migration of populations, increasing prominence of cultural-and literacy-based research opportunities evolves in the field of cancer education. crucially important is a need to assess, recognize, and address the effect of changing trends and recent events on cancer health disparities. in this editorial, we highlight the continued relevance of culture and health literacy in cancer education, and the promising opportunity that technology may play to advance health equity and social justice. culture and health literacy shape the experience of health and illness and are inherently interconnected due to the relationship between people's background and beliefs, as well as how people process, synthesize, and consume information in response to their everyday lives [ ] . culture is a type of shared identity, a way in which people make sense of and derive meaning from their reality. importantly, culture adds informative contextual perspectives [ ] , which are crucial to the development of meaningful cancer education programs and interventions. health literacy denotes the ability of people to use their "world of information" to make well-informed health choices [ ] . likewise, comprehending information is associated with how that information is presented and processed by the individual reflecting both the individual's cultural identity and literacy level [ ] . as in the covid- pandemic, this means recognizing measures that protect oneself from risk of exposure and spread (e.g., -second handwashing with soap and water, wearing a mask, social distancing), and signals comprehending terms like "flattening the curve" or "herd immunity" with a goal of helping people to go about their daily lives in a safe and healthy manner [ ] . too often, a critical discovery-delivery disconnect exists between scientific evidence and operational measures enacted (not merely suggested) to actualize the reduction of cancer health disparities [ , ] . available literature on healthcare disparities continue to highlight extant issues with cancer prevention, screening and survivorship, clinical trial enrollment, therapy adherence, and treatment modality variations (access and selection) among underserved and racial/ethnic minority populations [ ] [ ] [ ] , suggesting that many inequities stem from the fact that people experience and interpret disease and treatment differently (cultural influences), and many groups have different and unequal access to healthcare services and information (health literacy influences). reflecting on our own team's efforts in this field, eight cancer culture and literacy biennial meetings were held ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) in clearwater, fl, attracting over individuals. from to , the cancer, culture, and literacy institute (ccli-r e) engaged cancer control investigators in a -day institute, web-based modules, and mentoring activities to build momentum integrating culture and literacy into their research, education, and practice paradigms [ ] . fast forward a few decades, many past ccl participants are now prominent leaders in the fields of cancer prevention, cancer education, and health disparities, carrying out critical research and trainings that consider culture and literacy. to conceptualize a fresh training approach for the next generation of researchers, in , a -day roundtable was convened with ccli participants to explore emerging ccl topics and methods, identify knowledge gaps and opportunities in research, and recommend training directions. topics addressed in previous ccl training activities were judged still relevant (e.g., worldview perspectives, community-based participatory research [cbpr], development of low literacy materials, cultural/ linguistic dimensions and expressions of health). yet, new topics surfaced such as interdisciplinary research, workforce development in community partner engagement, dissemination and implementation science to support systems change, big data analyses (i.e., gis, network analysis), and particularly emerging technologies as well as historical and current events that play a role in people's learning, motivation and health decision-making in the context of the larger world system and local community realities (fig. ) . & amplify contemporary focus of culture and literacy in cancer education, practice, and research & advance interdisciplinary collaborations to invigorate research methods & restart ccli and expand training initiatives to "educate the educators" & harness technology to increase research connectedness and information reach to intergenerational, at-risk, and geographically dispersed groups & increase visibility of cancer, culture, and literacy in scientific/lay literature a commonality within these recommendations is a need for innovative technical skills that illuminate the nexus of culture and literacy-especially beyond the current dichotomous or nominal methods that tend to mask the significance of culture and literacy as social determinants of health [ ] . in order to facilitate the technical education necessary, roundtable participants agreed that other disciplines-such as engineering, computer science, communications/design, and geography-that regularly use technologies be integrated into cancer education and health disparity research partnerships to provide expertise and training. technological innovation requires cancer educators to be knowledgeable of technical and methodological skills lacking in current cancer disparity research and education workforce; otherwise, ameliorating health disparities remains an aspiration rather than an achievement. culture and literacy considerations have been apparent in many national imperatives [ ] [ ] [ ] ; nonetheless, headway in reducing cancer health disparities is slow. what lacks may be a connection between how we apply what we know and what we keep discovering about culture and literacy [ ] , along with information technologies that might facilitate the observation of how culture and literacy affect health outcomes in different dimensions, such as both geographically and temporally. the cancer education fig. . ccl interdisciplinarity concept field can progress rapidly through extensive information and technical skill exchange, fostered at multiple levels of workforce development. our greatest strengths are our interdisciplinarity-meaning we as a scientific community can, have, and must continue to influence policies and institutions to eliminate structural inequalities to reduce cancer health disparities. thus, we must further the inclusion of culture and literacy in cancer research, training, and practice, and stimulate improved conceptualization of culture and literacy including the application of technological innovations. there exist successful integrations of technology-infused culture-and literacy-specific cancer education to empower at-risk groups and marginalized communities. wallace and behringer [ ] draw from the traditional cultural influence of religion and spirituality by training clergy members from rural appalachia on the national library of medicine's medlineplus.gov database using ipads, with the intent to lay the foundation for a health ministry for their respective churches. as a result, clergy developed new perspectives for promoting healthy lifestyles and improving health literacy information in their congregations. research by im et al. [ ] reflects on their experiences recruiting asian-american breast cancer survivors in a technology-infused intervention. they found subethnic and linguistic preferences for being contacted by "culturally matched" study staff for recruitment and follow-ups, and distinct communication "app" preferences based on subethnic asian-american groups. to keep "ccl" at the forefront of our field, we need to develop guiding research and practice paradigms that integrate culture and literacy, intersectional frameworks, and policy change informed by fresh critical perspectives to bring to light social, historical, economic, and political conditions that give rise to both health and disease. transdisciplinary research must be bold-and critically delve into fundamental influences of racial injustice that affect underlying social determinants of health. heightened focus is needed to embark on dynamic cancer educational and technological innovations and inspired examples of transdisciplinary cancer training efforts for the current and prospective cancer health disparities workforce. as cancer educators, our resolve toward social justice and health equity should be further strengthened through proactive inclusivity and authentic and accelerated discovery, development, and dissemination. we must start to learn from history. our collective ccl efforts everywhere must prioritize equal justice and health equity for all populations. "injustice anywhere is a threat to justice everywhere." martin luther king jr. bringing a spotlight to the influences of social determinants of health the connect framework: a model for advancing behavioral medicine science and practice to foster health equity understanding and addressing social determinants to advance cancer health equity in the united states: a blueprint for practice, research, and policy cancer, culture and literacy: critical next steps in improving care for diverse populations the cultural framework for health: an integrative approach for research and program design and evaluation. national institutes of health culture and society. in health literacy: a prescription to end confusion the relationship between health literacy, cancer prevention beliefs, and cancer prevention behaviors covid- : an urgent call for coordinated, trusted sources to tell everyone what they need to know and do poverty, culture, and social injustice: determinants of cancer disparities us cancer centers of excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials training needs of clinical and research professionals to optimize minority recruitment and retention in cancer clinical trials aacr white paper: shaping the future of cancer prevention-a roadmap for advancing science and public health distance learning for communicating cancer, culture, and literacy: a model for cancer control advancement hhs action plan to reduce racial and ethnic disparities: a nation free of disparities in health and health care: u.s. department of health and human services topic/health-communication-and-health-informationtechnology . usdhhs office of the surgeon general potential of technology to improve the availability and use of health information on cancer subjects for clergy from rural communities issues in recruiting and retaining asian american breast cancer survivors in a technology-based intervention study publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgements the authors wish to acknowledge and thank past participants and mentors of cancer, culture and literacy educational activities over the last decades, including participants of the ccl roundtable, for their enthusiastic ideas that have continued to inform the application of cancer, culture and literacy in the field of cancer education. the authors also wish to acknowledge moffitt cancer center's health outcomes and behavior program for innovation funds that supported the ccl roundtable. conflict of interest the authors declare that they have no conflicts of interest. key: cord- - sct t authors: kujundžić tiljak, mirjana; reiner, Željko; klarica, marijan title: is there a better future of healthy aging? date: - - journal: croat med j doi: . /cmj. . . sha: doc_id: cord_uid: sct t nan the future of aging is being problematized based on the multidimensional concept of healthy aging defined as "the process of developing and maintaining the functional ability," which enables well-being in older age. older people have more complex health needs and are susceptible to developing chronic diseases. frailty, a common clinical syndrome in older adults, marked by a greater risk for poor health outcomes, including incident disability and higher hospitalization and mortality rate, severely affects health care services and society as a whole ( ) . most health services treat acute conditions and manage health issues in a fragmented manner. such fragmentation, as well as suboptimal time-management, could be especially dangerous for organizing adequate care for the elderly. there is a need for a health system reform that would ensure that each and every older person has access to evidence-based medical interventions and timely organized shared care. this is the only way to prevent further health deterioration, disability, and complicated care dependency later in life. active and healthy aging is a common problem in all european countries but could also be an opportunity for europe to spearhead the quest for innovative solutions. aging is one of the crucial societal challenges in croatia, as reflected in the croatian presidency of the council of the eu priority of the ministry of health of the republic of croatia -lifelong health care with the emphasis on challenges of aging. the conference aims to promote research and innovations that improve health and well-being of the aging population, as well as to initiate discussion on transformation of health and care services into more digitalized, long-term, integrated, and personalized care models, while promoting innovative ecosystems in order to deliver a better quality of life among the elderly. the first objective of the conference is to address the issues of aging of biological systems and present the state of the art in the areas of regenerative medicine, neuroscience, clinical medicine, and other fields of medicine. the accent is on personalized and integrated medicine and innovative translational research leading to promising applications in regenerative medicine. the conference will also include discussions on advanced personalized diagnostic strategies enabling individualized therapy and accurate predic- tions of treatment outcomes. the implementation of modern sophisticated genomic methods in routine diagnostics for personalized medicine and the scale up of demanddriven innovations in health care systems includes organizational, economical, technical, and clinical aspects. if we want to extend healthy and independent living, we need to create robust and sustainable solutions potentially applicable in any eu state. the second objective of the conference is to assess the use of smart technologies in age-friendly ecosystems. the conference aims to initiate a discussion on the possibilities to scale up innovations and solutions for age-friendly environments, applications for independent living, and solutions for age-friendly buildings, cities, and environments, undertaken by different european cities, regions, or municipalities. smart ict solutions and advanced artificial intelligence (ai) can be used to provide personalized health care and social services, overcome immobility, cognitive, and vision problems, and improve general quality of life. digital technologies can encourage all groups of patients, and the elderly in particular, to assume a more active role in their health management. hopefully, the conference discussions will lead to discovering the ways how all european citizens can meaningfully use these new technologies and benefit from them. the third objective is to analyze the issues of aging and health care system sustainability at various levels -institutional, regional, state, and eu level. in the area of health systems sustainability, the conference focuses on the following themes and their relation to extended life and aging: health system financing, health system organization and structuring bottom up policy with successful examples, and demographical and ethical challenges. the role of digitalization in health care is vital in advancing solutions to challenges related to all three conference topics, particularly as health systems are often not keeping pace with the integration of the new technologies. the possible solutions to overcome disparities in the availability of technological developments and health and digital literacy of the elderly in different european countries and regions are particularly important. the bfha conference aims to create a platform for sharing the successful examples of using advanced technologies to increase the functionality of aging citizens and for learning from these examples. addressing the use of advanced technologies for improving the functionality and well-being of aging citizens to the benefit of a transformative and mission-oriented european research and innovation agenda goes beyond the traditional focus on scientific impacts of research. it emphasizes societal impacts, structuring impacts on policymaking and policies, as well as impacts on innovation and economy. unfortunately, at the beginning of who decade of healthy aging ( - ) the whole world is facing the coronavirus disease (covid- ) pandemic, which endangers mostly elderly and chronic patients. the pandemic outlines the importance of disease prevention using well known hygiene measures. however, it also reveals the unequal access to health services faced by older patients. in some countries, top ranking hospitals recommended that patients with covid- who are older than , between and years with one-organ failure, and between and years with two-organ failure should not be given priority if there is a lack of intensive care units beds. croatian bases its disease prevention and health promotion strategies on the ideas of dr andrija Štampar, one of the founders of the who ( ). he began his fight for better public health in the first half of the th century ( ) . at that time, sanitary and hygiene situation was poor, and the major health problem were infectious diseases, particularly malaria and tuberculosis ( ) . andrija Štampar became highly active in public health efforts in croatia and abroad. his definition of "health as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" is still a part of the who constitution, which was adopted on april , . in his speech as acting president of the first world health assembly held in geneva in , Štampar said the following ( ): "disease is not brought about only by physical and biological factors. economic and social factors play an increasingly important part in sanitary matters, which must be tackled not only from the technical, but also from the sociological point of view.... health should be a factor in the creation of a better and happier life. since health for everyone is a fundamental human right, the community should be obliged to afford all its people' s health protection as complete as possible. medical science must adopt a positive rather than defensive attitude. great tasks await the world health organization in this field, and its future success will largely depend on its ability to put these ideas into practice. " in the light of his words, one can conclude that all people, regardless of their origin, should be granted the opportunity to live a long and healthy life. yet, the environments in which we live can promote health or degrade it. environment and spatial epidemiology play an important role in defining the health risks of a population. an-other important factor is the accessibility to quality health regardless of social status and other sources of deprivation. population aging makes these issues increasingly more visible. healthy aging is about creating the social climate and opportunities that enable people to thrive throughout their lives. the covid- pandemic has shown the importance of every person's involvement in creating a healthy environment, healthy relationships, building solidarity, and social awareness of health needs. let us use this newly obtained attitude to improve the care for the elderly and lead the world to a better future of aging. health, demographic change and wellbeing. brussels: european commission brussels: european commission barroso% % % % -% europe% % -% en% version brussels: european commission; c decade of healthy ageing - -a final proposal at the th who executive board meeting in february . geneva: who; the frailty syndrome: definition and natural history care for health cannot be limited to one country or one town only, it must extend to entire world: role of andrija Štampar in building the world health organization th anniversary of andrija Štampar school of public health -what can we learn from our past for the future? the th anniversary of andrija Štampar school of public health key: cord- - g n d authors: kimball, ann marie; moore, melinda; french, howard matthew; arima, yuzo; ungchusak, kumnuan; wibulpolprasert, suwit; taylor, terence; touch, sok; leventhal, alex title: regional infectious disease surveillance networks and their potential to facilitate the implementation of the international health regulations date: - - journal: medical clinics of north america doi: . /j.mcna. . . sha: doc_id: cord_uid: g n d the international health regulations (ihr) present a challenge and opportunity for global surveillance and control of infectious diseases. this article examines the opportunity for regional networks to address this challenge. two regional infectious disease surveillance networks, established in the mekong basin and the middle east, are presented as case studies. the public-private partnerships in the networks have led to an upgrade in infectious disease surveillance systems in capacity building, purchasing technology equipment, sharing of information, and development of preparedness plans in combating avian influenza. these regional networks have become an appropriate infrastructure for the implementation of the ihr . the implementation of the new international health regulations (ihr) requires the proactive establishment of competence within all world health organization (who) member countries to control infectious diseases within their territories. some investigators have contended that the establishment of regional networks for disease surveillance actually may diminish the ability of low resource settings to establish such competence. this article examines this theoretic possibility by closely describing the experience of regional networks, focusing on two such networks, the middle east consortium on infectious disease surveillance (mecids) and the mekong basin disease surveillance (mbds) networks. these two cases clarify the contribution of such networks to the successful implementation of the ihr. the past decades have witnessed increasing globalization of commerce, travel, financial flows, production chains, and services. the market forces behind this globalization do not always apply to public safety and protection; thus, the public health sector has been slow to globalize and too few within the economic and trade sectors embrace the urgency of supporting the transnationalization of public health. while globalization of the health sector inches along, extension of production chains and intensification of agriculture stress public health security at the point of origin (commonly in resource poor settings). high-profile pandemics (eg, hiv/aids and severe acute respiratory syndrome [sars] ) point to the lack of an effective global public health safety net. fig. illustrates the challenge of transnational infection and the need for transnational response. resource poor settings continue to struggle with high levels of preventable and treatable endemic and epidemic diseases. given the lack of economic incentive to globalize public health protection, the task of realizing this global public good rests with national governments, international agencies, and philanthropic interests. as travel and commerce so thoroughly interconnect the globe that an outbreak in asia today may be an outbreak in north america tomorrow, or vice versa, the rhetoric of global disease security has become more urgent. although there are potentially several drivers for the rise of regional networks for surveillance, at least two are in play. first, as markets globalize, consolidation and scale of activity gain importance. increasingly active trading economies have come together in larger economic groups (eg, the european union and the asia-pacific economic cooperation [apec]). as blocs of trading economies have emerged, new common concerns about health security also have come to the fore. second, in postconflict areas divided by war, common geographic zones of activity come together for mutual economic benefit during recovery. as commerce and travel increase economic integration, population health security becomes an important issue. this article provides a brief review of the rise of regional groupings of countries that have created networks for disease surveillance and examines theoretically and through the experiences of these regional networks how they may facilitate the implementation of the revised ihr ( ) . although this article offers a catalog of several of these systems (table ) , the universe of networks described is not exhaustive. discussion focuses on the regional networks of mecids and mbds, which illustrate the challenges and opportunities these networks afford. the emergence of novel infectious disease threats has increased in the modern era, raising the need for new surveillance capabilities. zoonotic origin accounts for the majority of these events, and the increasing need to coordinate human and animal health is an additional challenge for nascent surveillance systems. with the renewed appreciation for the speed of transmission of agents given modern travel volumes and rates, speed and accuracy of information become more important. additionally, with the broad geographic dispersal of pathogens in products and people, the ability to sensitively, specifically, and promptly identify particular strains or subtypes of organisms using modern diagnostic techniques becomes important. such identification is critical for ( ) effective disease investigation to detect the source, ( ) vaccine development, and ( ) tailoring treatment regimens for individual patients affected. in the early s the return of old epidemics, such as cholera in south america, and the emergence of new infectious agents, such as ebola hemorrhagic fever, sparked a landmark study by the united states institute of medicine. the study, chaired by the late dr. joshua lederberg, identified new pathogen emergence as a cross-cutting theme in global infectious disease and began to identify the anthropogenic factors behind such emergence. the ongoing occurrence of emergent infections provoked a resolution calling for the revision of the ihr ( ) at the world health assembly. in , the world health assembly adopted a resolution on global health security epidemic alert and response in which who was to support its member states in identifying, verifying, and responding to public health emergencies of international concern. in , the world health assembly reiterated the need to revise the ihr to reflect the changes in its resolution, global public health response to natural occurrences, and accidental release or deliberate use of biologic, chemical, or nuclear agents that affect health. the outbreak of sars, however, prompted the world health assembly, in , to decide on establishing the intergovernmental working group on the revision of the ihr to accelerate the process. the revised ihr ( ) were adopted, by consensus and after months of negotiation, in may by the th world health assembly. they focus on strengthening global surveillance, improving communication between who and member states, and ensuring that each country has the laboratory capacity to identify outbreaks rapidly. the revised regulations encourage governments to participate in an international network of surveillance networks through reviewing their current surveillance strategies kenya, tanzania, uganda regional surveillance networks and implementing programs capable of contributing to global outbreak intelligence. member states are required to notify who and neighboring countries of all events potentially constituting a public health emergency of international concern and to maintain a national focal point, available at all times, to mediate communication between who and the government. the revised regulations, a broader binding pact than before, thus call for actions by member states and the who. the passage of the ihr puts the world on a fast track to implementation. networks, such as mecids and mbds, have reinforced national compliance efforts. the regulations dictate minimum requirements for surveillance and response, although their explicit agenda is to upgrade these systems on national levels and provide specific measures to prevent disease spread at airports and other entry points. who maintains that surveillance is the cornerstone of efficient disease control and the key to mounting an effective response, and the revised regulations provide some mechanism for who to collaborate with member states after notification. in an era of globalized infectious diseases, all countries are believed to have a stake in the success or failure of surveillance and response capacity development in any one country. although global surveillance programs often are based on existing disease-specific cooperation of regional networks (eg, who global influenza surveillance networks), the revised ihr provide a framework for mandating countries to coordinate their action through a universal network of surveillance networks (ie, a network of national and regional networks). the regulations also provide a binding legal structure and raison d'ê tre umbrella to regional networks for solving practical issues near and within national borders. thus, regional surveillance networks, such as mbds and mecids, can facilitate the ihr and play an important role in their implementation. for example, in , mecids members convened a workshop on implementing the ihr in the event of an influenza pandemic. this event was held in cooperation with who headquarters and who offices in the eastern mediterranean and european regions. as pathogens do not respect national borders, regional outbreaks require collective regional surveillance, response, accountability, and responsibility. the perception is that if the revised ihr facilitate early detection and rapid implementation of effective control measures, most health emergencies will be dealt with at a regional or national level and never become a global threat; hence, a regional approach to surveillance may further strengthen the goals of mecids and mbds and help realize the greater goal of global health security. lastly, as who is to be notified only of public health events of international concern, discussions by regional members may be useful in determining the notification threshold or procedures. to build, maintain, or improve regional surveillance networks, it is important to have a defined set of core capacities. core capacities include the establishment of common laboratory standards, an effective surveillance system (based on disease, syndromic, or rumor reporting), and effective response capabilities (eg, contact tracing and monitoring through field epidemiology). for example, each member state has to ensure that it has the laboratory capacity to rapidly identify outbreaks; , to do so, provisions for technical support and extra resources for less-developed countries also are written into the revised ihr ( ). the core response capacity requirements apply at all public health response levels-from local to intermediate to national. strengthening national public health capacities contributes to improving national and international readiness to detect, verify, investigate, and control disease outbreaks that have the potential to spread internationally. importantly, the revised ihr specify measures to prevent disease spread at designated points of entry. , operational and technologic communications and trust across countries are central tenets of regional surveillance networks. moreover, each country's particular strengths can be leveraged across regional network partner nations. mecids and mbds have acted as catalysts for the introduction and spread of new communications and laboratory technologies. for example, mbds members are working with several international funding and technical partners to increase technical capacity for surveillance and disease control through computing; high-speed internet access recently has been enhanced by the trans-eurasia information network effort in vietnam. when vietnam lacked such internet capacity in , thailand facilitated vietnam's participation in the multinational videoconference on pandemic preparedness (organized by apec emerging infections network) by hosting the vietnamese representatives at their videoconference center. as another example, tabletop exercises in individual mbds countries and a regional mbds exercise suggest that each country has unique strengths that can be considered for application across the region, such as electronic surveillance reporting in china; epidemiology training in thailand; laboratory capacity in thailand, china, and vietnam; community surveillance in cambodia; and government organization for national influenza preparedness in lao people's democratic republic (pdr) (dr. moe ko oo, mbds coordinator, personal communication, ). given the focus on food safety in the eastern mediterranean, mecids has elected to share food-borne disease information. laboratory capacity has been reinforced with the introduction of pulsed-field gel electrophoresis technology for pathogen identification (eg, pulsenet). this effort has been facilitated through the mecids collaboration with donors, coordinated by ghsi (the world bank, the government of the united kingdom, the bill and melinda gates foundation, the nuclear threat initiative, ibm, and becton dickenson). financial and other forms of support were carefully used to enhance capabilities, particularly in early detection and identification, and to bring the partners' differing capabilities to a level at which they can operate efficiently together in sharing data and other cooperative activities. thus, the regional network provides a forum for sharing lessons learned and, over time, harmonizing such efforts to assure systems (and operator) interoperability. of equal importance to core capacities are core competencies, which entail appropriate training of qualified workers and maintenance of necessary human resources. training in applied epidemiology, informatics, and laboratory methods for key surveillance personnel is essential, and such training needs to be conducted at the frontline level (eg, routine surveillance with regular reporting) and at the supervisory, senior level (eg, field epidemiology training program [fetp] trainers and trainees). it is important that the local frontline workers be included in surveillance, disease investigation, and response training. doing so empowers the community, evidenced by success stories of local volunteer workers and disease control officers participating in surveillance and response activities (eg, thai avian influenza preparedness and response system in response to human case from across the border in lao pdr in early ). the key to a strong surveillance and response system is effective training and development of core competencies. more than national fetps around the world are patterned after the united states centers for disease control and prevention epidemic intelligence service; a similar program, european programme for intervention epidemiology training, is conducted in europe. , mecids partners are establishing the middle east program for interventional epidemiology training, following the european model. thailand has a mature fetp, which benefits its neighbors in regional outbreak control. surveillance competencies are central to these programs, similar to competencies developed for applied epidemiologists in the united states. given the rapidly evolving nature of modern surveillance approaches with links to public health informatics, additional efforts are underway to include training in technologic aspects of surveillance systems. these informatics skills are critical emerging competencies for surveillance workers. at a practical level, imported models must be tailored for local use and new solutions may be found by local innovators as informatics skill levels increase. thailand, for example, has taken the lead in mbds to create a center of excellence in public health informatics in collaboration with the university of washington. mecids and mbds illustrate that effective regional surveillance can be realized even in difficult and disparate political environments. both groups provide a forum to share information, develop relationships, and build capacity, and they have proved effective during recent regional outbreaks. these two networks have similar goals and focus on many of the same threats to public health, yet their structures and the political climates in which they exist are different. the capitals of jordan, israel, and the palestinian authority are located within km of each other. the constant flow of goods, family ties among palestinians residing in the three countries, and human travelers that pass over their borders each day has led tulchinsky to refer to these inexorably related countries as one ''epidemiologic family''. before the palestinian uprising (intifada), which began in , a young but healthy cooperation existed on health matters between israel and the palestinian authority. with the conflict, communication and collaboration came to be low profile as far as public health issues were concerned. , in this political climate, two international nongovernmental organizations, search for common ground and the global health and security initiative (ghsi), which operates within the nuclear threat initiative, facilitated the establishment of mecids in . mecids is considered a unique model of trilateral sustainable activity. this intergovernmental partnership among the ministries of health in jordan, israel, and the palestinian authority has been effective on many levels, including harmonizing diagnostic and reporting methodologies; common training; data sharing and analysis; improving detection and control of infectious diseases; facilitating cross-border communication; dealing with avian influenza outbreaks in the three countries; and, finally, creating the potential for the trust and cooperation fostered through this collaboration to translate into cooperation on other issues. using the layered structure of the public health services in each of its member countries, mecids currently gathers data on food-borne illnesses caused by two pathogens, salmonella and shigella, at the district, national, and international levels. at the district level, a network of clinical laboratories covers the many districts of each country; the national level includes a national center for disease control and a national laboratory; and the international level consists of one regional health information center-the cooperative monitoring center in amman, jordan. national centers for disease control collect data from their district laboratories and report important information to the regional center in amman. this hierarchic architecture allows for systematic disease reporting that helps identify potentially dangerous situations before they become serious epidemics. the second example of regional surveillance is mbds, a collaboration between cambodia, china (yunnan and guangsi provinces), lao pdr, myanmar, thailand, and vietnam. southeast asia experienced intense conflict during the cold war era but has since made enormous strides toward peace and economic development. implementation of trade liberalization policies, such as the association of southeast asian nations free trade area, the ayeyawady-chao phraya-mekong economic cooperation strategy, and the entry of vietnam and thailand into apec, have greatly increased the ease with which goods, services, and capital flow throughout the region. with support from the rockefeller foundation, who, and other organizations, mbds was established in to deal with the public health challenges of high-volume regional trade and travel. its activities include epidemiologic training, cross-border exchange of information, joint epidemic response and investigation, and joint tabletop exercises on pandemic influenza preparedness. because some mbds member countries belong to who's western pacific region (cambodia, china, lao pdr, and vietnam) whereas others belong to the southeast asian region (myanmar and thailand), coordination under the who umbrella adds some bureaucratic burden. based on trust and close friendships, built through many years of interactive learning and collective action, mbds has played an important role in filling this bureaucratic gap. mbds uses a reporting structure that links countries at the national, provincial, district, community, and village levels. members have established communication links at parallel levels and rely on a system of periodic reports and cross-border meetings to facilitate information exchange and build trust between parties. , dr. suwit wibulpolprasert, active member and former mbds executive board chair, commented, ''this network is an excellent example of effective implementation of the international health regulations, with rapid formal and informal reporting of diseases of public health emergencies across borders''. the stability of the southeast asian region allows for a formal partnership between countries of the mekong basin; the legal basis of mbds is two memoranda of understanding signed by the ministers of health from the six countries. this organizational architecture creates a strong and durable partnership that has well-defined responsibilities and expectations. in contrast to mbds, the volatile political situation among mecids countries has led to an informal memorandum of understanding agreement among partners. it is not bound by a formal decision-making process and, therefore, has the freedom and flexibility to respond quickly to changing priorities in infectious disease control. mecids and mbds have been tested by disease outbreaks. mecids, originally established to monitor food-borne infections, has provided a robust platform to broaden surveillance activities to include other serious emerging infections, such as avian influenza h n . avian influenza among poultry hit the region in march , and although mecids had been active for only years, the reporting system, open lines of communication, and cooperative control measures proved essential in mitigating the impact of the outbreak. the revised ihr, although initial implementation was not required until june , , were put into practice by a joint decision among mecids partners and shown to be effective. in , mecids partners conducted a workshop on the implications of the revised ihr in pandemic influenza preparedness. the year saw a large increase in the number of cholera cases in northern thailand and southeastern myanmar, with cases resulting in seven deaths. from june to august , an outbreak of cholera el tor inaba ( confirmed cases) occurred in tak province, one of thailand's northern provinces that borders myanmar. as one fifth of the cases were found in migrant workers from myanmar, the thai mbds country coordinator, who acts as the ihr focal point, informed his myanmar counterpart. the source of the illnesses was not identified in this outbreak and officials of both countries in the border area responded by encouraging citizens to follow proper hand-washing procedures and boil their water. from mid-september to october of the same year, an outbreak of cholera el tor ogawa ( confirmed cases) occurred in provinces of the northeastern region of thailand and crossed the border into vientiane, lao pdr. the disease control officer of lao pdr notified who and the thai mbds counterpart. in this instance, with an increased disease surveillance and response effort, the thai fetp and the surveillance rapid response team of several affected provinces, in collaboration with the laotian authorities, were able to trace the infection to uncooked blood cockles. identifying the source of the outbreak was a major factor in reducing illness and protecting public health. the successful ongoing collaboration within mecids and mbds provide two examples of effective regional surveillance systems implemented in areas historically, and even currently, embroiled in conflict. as leventhal and colleagues argue, ''irrespective of political circumstances, the common threat of an emerging infectious disease serves as an opportunity to bridge disputes and focus on humanitarian and health matters for the common good of all bordering countries.'' who maintains that international partnerships are essential in implementing the revised ihr; therefore, finding common ground in regions of conflict is especially important as it promotes health cooperation in areas where it is most lacking. to maintain surveillance core capacities and competencies, collaborative partnerships are critical and long-term investment strategies are needed. supporting regional surveillance programs can be an efficient way for external partners to help resourcepoor countries develop their own national surveillance infrastructure. and, regional initiatives investing in surveillance programs on emerging infectious diseases may directly help developing countries meet the revised ihr's new core requirements. these networks have the potential to enhance the transnational capacity for disease response (shown in fig. ) . today, an increasing number of private sector foundations with a public health focus are funding disease surveillance programs in limited resource settings. such enhanced support can greatly assist in sustaining the core capacities and competencies necessary for successful regional surveillance networks. public-private partnerships for infectious disease surveillance are becoming increasingly common. an encouraging effort has begun, with support from the rockefeller foundation and ghsi, to develop a process for the various operating and nascent regional infectious disease surveillance systems to share best practices on issues, such as governance and the technical aspects of cross-border surveillance. this effort should have the effect of bringing more government and private sector resources into infectious disease surveillance capabilities, which, if sustained, will bring about an increase in overall global surveillance capacity. this complements the essential and more topdown efforts of the who's strategy for epidemic alert and response that also relies on collaborative partners, including who collaborating centres, nongovernmental organizations, and industry. countries, therefore, will benefit from the renewed impetus to strengthen national capacity in surveillance and response and from the enhanced access to international investors interested in improving health in countries across the world, in the interest of global health and security. the revised ihr ( ) encourage a new paradigm of global public health intelligence. with mandatory reporting procedures and requirements for building surveillance and response capacity, the revised ihr are a move toward more effective global health security. the revised regulations have broadened and diversified the effort for global infectious disease control. this article has addressed the rise of regional networks and focused on how two such networks have contributed to the implementation of the ihr. specifically, through hosting regional workshops for ihr implementation, introducing and implementing communications and laboratory technologies in member countries, responding to regional outbreak events, and linking field investigation efforts to response, the networks have moved their member groups closer to the implementation goal. far from diminishing the abilities of fragile public health systems, these networks have reinforced operational competence. in resource-poor settings and regions of political instability, the need for cooperation is even more urgent. the examples of mbds and mecids illustrate the benefits of regional cooperation, communication, and trust building. they demonstrate that historical conflict, and even current political strife, can be overcome by focusing on common interests. the trust and communication mecids and mbds partners built were a foundation for upgrading the infectious disease surveillance systems in each country, in terms of training personnel and purchasing laboratory and information technology equipment. through successful communication and capacity building, these networks have effectively responded to disease outbreaks (eg, mecids's response to the outbreak of avian influenza and mbds's response to the cholera outbreaks of ) and increased their ability to address future emerging infectious disease threats. as is true with mbds and mecids, regional networks have greater access to international investors whose objectives are to strengthen the health of recipient countries while also improving overall global health security. investment is a key concept in the new paradigm; it is an idea that the return on an investment in surveillance capacity and cross-border cooperation is the improved health of all nations and all global citizens. the revised ihr ( ) provide the impetus for change, and regional networks are one important way of achieving that change. from the field side of the binoculars: a different view on global public health surveillance 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regional collaboration in the middle east to deal with h n avian flu public health education in a conflict area: a report from israel middle east consortium on infectious disease surveillance (mecids) public health affinity domain (phad)-regional cooperation in the middle east: israel, jordan and the palestinians. healthcare and life sciences seminar building the peace in southeast asia. the fourth high-level meeting between the united nations and regional organizations on cooperation for peace-building mekong basin disease surveillance network signs new memorandum of agreement at the world health assembly. maximnews strengthening national capacities for epidemic preparedness and response in support to national implementation of ihr public health surveillance: learning from regional network diplomacy, science and technology. bellagio call for action. bellagio (italy): global health and security initiative the world health report -a safer future: global public health security in the st century the authors would like to thank ms. alicia silva-santisteban for her administrative support. key: cord- -pqah j authors: waite, roberta; nardi, deena title: effects of covid- on the mental health of black and brown racialized populations in the u.s date: - - journal: arch psychiatr nurs doi: . /j.apnu. . . sha: doc_id: cord_uid: pqah j nan although this group comprises % of the u.s. population; this is contrasted with the white population, who make up % of the u.s. yet accounted for % of these hospitalizations (aubrey, ) . the hispanic and latino communities are also harder hit by the outbreak. for instance, in new york city, % of the new yorkers who have died of covid- are latino, despite making up % of its total population (mays & newman, ) . this alarming disparity in covid- mortality rates cannot be surprising considering that chronic health conditions, such as heart failure, asthma, hypertension, diabetes mellitus and hiv, are at much higher rates, begin earlier and are treated later in the black population community than in the white population (williams et al., ) . native americans, especially those who live in rural areas and reservations such as the navajo nation, have been especially hard hit from pandemics: nbc news calls the navajo nation's health services, managed by the u.s. indian health services (ihs), "limited,"(abou-sabe et al., , para. ). a quarter, or % of the diné population died from the "spanish flu" of ; during the swine flu epidemic, dinė or navajo people, died from that flu at a rate " - times higher than other americans"; currently, the nation's covid- infection rate is "ten times higher per capita than its neighboring state, arizona" (lange, , para. ) home, it serves as a safety net for its patients and many community members. like many other health care organizations, it experiences delays in receiving needed testing supplies for covid- however this testing is currently underway. clinical services however quickly transitioned to enable access to care for patients. telehealth for clinical services for primary care, dental and behavioral health were rolled out after its partner, fpcn obtained the necessary approvals from insurance companies and department of state, bureau of professional and occupational affairs licensing boards. specifically, psychiatric services in primary care including integrated behavioral health consultants and the psychiatric nurse practitioner were able to maintain their transdisciplinary team orientation with all providers in primary care to attend to the needs of patients across the lifespan. likewise, the larger behavioral health department shifted to operating at full capacity using telehealth including hippa compliant zoom. on average, % of sessions are now virtual, therefore, routine van services were placed on hold; however increased delivery drivers were hired for the health centers pharmacy which delivers medications for free within a -hour time frame to any patient living in philadelphia. similarly, its mind-body services for both patients, community members and staff were all converted to virtual sessions including programming for fitness, yoga, and mindfulness meditation. additionally, zumba and pound classes were offered to staff. these services are integral to mitigating and managing stress and promote engagement with others. social services have also enhanced their work at the health the goal is to develop "hyperlocal" (neighborhood level) strategies to slow the spread of coronavirus and improve health outcomes for residents of those communities hardest hit by this crisis. these communities have struggled with limited access to healthcare services and insufficient primary care providers, long standing unemployment, a dearth of businesses in the community, chronic illnesses, and a panoply of health risks and stressors that contribute to the pronounced lifespan gap between white and black chicago residents (pratt, ) the panel consists of not only the usual business leaders and healthcare experts, but a representative from nami and community advocates such as mr. anton seals jr., whose words are quoted at the beginning of this piece. as mayor lightfoot said, "this cannot be temporary scaffolding. it's got to be laying a foundation for a permanent fix to many of the problems that for too long we have ignored or said, they are too big to solve" (pratt, , p. ) . we will be watching what happens to the chicago panel and its work after the pandemic is over. we hope the work of the panel and these other models will be used as best practice guides to change the economic maps and social injustices that foster these health disparities still, especially for the black and brown racialized populations in this country. the new normal they can create should include better distribution of resources, such as clean water, more primary care providers, telehealth and telecounseling services, to people who need them…wherever they live. this should not be a matter of "if you pay, then you can play", but a best practices model of incorporating the major social determinants of health into assessment and treatment services for all needing health services, now during the pandemic and afterward. inequities in health are fueled by cultural and societal norms based on racism and racist practices in the united states particularly during the covid- pandemic, and will be evident in j o u r n a l p r e -p r o o f its aftermath. health equity, a process which assures conditions of optimal health for all peoples, requires needed attention to the social determinants of health: economic stability, education, community services and safety, healthcare, respectful communications, and affordable decent housing, for all populations. racial diversity has greatly increased in the u.s., and the needs of our diverse population should inform health care practices and policy making in order to preclude disparities in these determinants, as well as the healthcare inequities that persist most pointedly along racial lines. but knowing this is not enough: doing is what is called for. navajo nation braces for a surge of coronavirus cases american inequality meets covid- . (n.d.). the economist covid- racial disparity: african americans may end up in hospital more often : coronavirus live updates : npr black people are dying of covid- at virus is twice as deadly for black and latino people than whites in n.y.c. the new york times mayor creates response teams for hard-hit neighborhoods. . social determinants of health race, socioeconomic status, and health: complexities, ongoing challenges, and research opportunities key: cord- -p y er authors: lillie, patrick j.; samson, anda; li, ang; adams, kate; capstick, richard; barlow, gavin d.; easom, nicholas; hamilton, eve; moss, peter j.; evans, adam; ivan, monica; phe incident team; taha, yusri; duncan, christopher j.a.; schmid, matthias l.; the airborne hcid network title: novel coronavirus disease (covid- ): the first two patients in the uk with person to person transmission date: - - journal: j infect doi: . /j.jinf. . . sha: doc_id: cord_uid: p y er nan in this journal, zhu et al. recently reported the results of their genomic analysis of multidrug-resistant klebsiella pneumoniae isolates from individual patients before and after colistin treatment highlighting the rapid emergence and multifaceted molecular mechanisms of colistin resistance in k. pneumoniae. this work highlights the therapeutic and public-health challenges of colistinresistance (cr), which is increasingly used as a large resort antibiotic, despite its unattractive toxicity profile and narrow therapeutic window. oral non-absorbed colistin has been proposed as a decontamination strategy in intensive care units and for patients carrying multidrug resistant enterobacterales (mdr-e). , the impact of decolonization strategies in terms of emergence of cr has rarely been monitored because no reliable selective medium existed and cr was not considered a public-health problem. recently, reliable universal culture media have been developed to screen for cr. here, we studied the impact of non-absorbed oral colistin on the emergence of cr in the gut microbiota of patients from the rgnosis-wp randomized controlled trial. thirty-nine subjects colonized with mdr-e were randomized to receive oral colistin sulfate miu times a day + neomycin sulfate mg bid for days followed by a fecal microbiota transplant (fmt) from healthy donors, or no intervention. stool samples were collected on visit v (screening sample), v (after days of oral decontamination and before fmt for the intervention group), v , v and v , respectively - days, - days and - days later. stool samples from donors and subjects from the intervention group and from the control group were available for this work and plated on drigalski plates (control) and superpolymyxin r plates. colony forming units (cfu) counts of all gram-negative rods were determined. isolates growing on superpolymyxin r plates were identified by maldi-tof; cr was confirmed by the culture-based rapid polymyxin np test and mic determined by the microdilution method. the limit of detection was cfu/g of stool. cr-e. coli were sequenced using the illumina hiseq technology. to determine whether cr isolates were present before the intervention, a specific mcr- pcr was performed on patients stool prior to intervention (v ) and on the donor's stool. electroporation of plasmids was performed to localize the gene conferring resistance to colistin and neomycin and molecular typing of the electroporants was performed using pcr based replicon typing (pbrt). ✩ université de paris, iame, inserm, umr- no patient or donor included in the trial carried cr isolates on v . among the patients in the intervention group two ( . %, [ic − ; ], p = . ) carried cr isolates at least at one visit after the intervention ( fig. ) . no cr-enterobacterales was detected in the stools of subjects from the control group. among both subjects with cr-enterobacterales, one carried log cfu/g of hafnia paralvei , a species which is intrinsically resistant to colistin (mic = mg/l), also resistant to neomycin (mic = mg/l) on visit and the other carried log cfu/g and log cfu/g cr-e. coli at visits and , respectively, with a colistin mic at mg/l. relative abundance of cr-e. coli increased between v and v from . % to % of the total enterobacterales population. the cr-e. coli recovered at v and v both belonged to phylogroup c st group and carried the serotype o :h . a plasmid-borne mcr- . gene encoding for cr as well as a aph( )-ia gene conferring resistance to neomycin were identified, both being co-located on the same inchi plasmid. in addition, resistance genes conferring resistance to hygromycin b ( aph( )-ia ), sulfonamides ( sul ), tetracyclines ( tet(a) ) and phenicols ( flor and cata ), all antibiotics used in veterinary medicine, were evidenced. for both subjects, cr strains could not be retrieved in the initial stool of the subject or in the donor's stool. pcr experiments performed with specific primers to detect mcr- gene directly on the pre-therapeutic stool were also negative. to our knowledge, this is the first report of the in-vivo selection of cr-enterobacterales in the gut microbiota of patients after oral decontamination by colistin. the selection of cr strains (a naturally-resistant h. paralvei and a mcr- producing e. coli ), both resistant to colistin and neomycin, may be the result either of the enrichment process by sod of preexisting cr strains that had not been initially detected because of very low abundances, or of an exogenous acquisition, either from other individuals or through fmt. indeed the transmission from fmt of mdr strains from positive donors is a potential risk. despite our efforts to decrease the limit of detection of mcr producers by using a pcr technique directly on the pre-therapeutic stool sample and the donors' stools, we failed to detect the parental strain, either because cr strains were in intestinal niches, the limit of detection remained too high, or the strain was acquired exogenously. however, the mcr- -positive e. coli is likely of animal origin according to its genetic features and its co-resistance profile. indeed, phylogroup st is frequently encountered among avian pathogenic e. coli (apec) and co-resistances to many antibiotics used specifically in veterinary medicine is striking. furthermore, the aph( )-ia gene confers resistance to neomycin and paromomycin, the latter commonly used in cattle and pigs. the selection of the mcr- producer is an illustration of the "one health" problem of resistance: a strain likely to have been selected by veterinary antibiotics among animals ended up in a patient's gut, later enriched by the use of colistin and neomycin as decontaminant. although the small number of subjects is a clear limitation, this observation is a "proof-of-concept" of the risk of selection of cr-enterobacterales after oral colistin treatment and fmt, at a time when colistin is one of the last resort antibiotics to treat mdr-enterobacterales infections. the selection of commensal cr-e. coli is especially worrying, given the pathogenic potential of e. coli and its ability to widely colonize animals and humans. given the controversial results of oral decontamination by colistin, we believe it should only be used with precautions and with thorough monitoring of cr. we read with interest a recent paper in this journal by luzatti and colleagues, who explored the significance of the presence of herpes simplex virus (hsv) dna in lower respiratory tract (lrt) specimens for the diagnosis of hsv pneumonia in immunocompromised patients. the authors underlined the difficulty in gauging the clinical relevance of such a laboratory finding in the absence of histopathological data, as hsv shedding in the lrt may occur in the absence of disease. the interpretation of real-time pcr results for diagnosis of pneumocystis jirovecii (pj) pneumonia (pjp) faces an analogous challenge, since the presence of pj dna in lrt may reflect colonization (carriage) rather than infection. there is limited information on the clinical value of pj real-time pcr in diagnosing pjp in patients with hematological diseases; - this is exceedingly challenging as the sensitivity of direct examination procedures is suboptimal due to low fungal burdens. here, we report on our experience on this matter. a total of episodes of pneumonia occurring in consecutive patients with hematological disorders in which pjp was considered in the differential etiological diagnosis were included. of these, episodes developed in patients undergoing either allogeneic hematopoietic stem cell transplantation-allo-hsct-( n = ) or autologous-hsct ( n = ), and in non-transplant patients (acute leukemia, n = ; lymphoma, n = ; chronic leukemia, n = ; others, n = ). the patients were attended at the hospital clínico universitario-hcu-( n = ) or at the hospital universitario politécnico "la fe" -hlf-( n = ) between june and august . no patients in the cohort tested positive for hiv. this study was approved by the respective hospital ethics committee and informed consent was obtained from all patients. a single specimen per episode was available for diagnosis (bal fluids, n = ; sputa, n = ; ta, n = and bronchial biopsy, n = ). the realcycler pjir kit r (progenie molecular, spain) was used at hcu, and the pneumocystis jirovecii real time pcr detection (certest biotech; zaragoza, spain) was employed at hlf (see footnote in table ). both assays target the large sub-unit of ribosomal (mtlsu) rna gene. preliminary experiments using bal specimens indicated that both assays yield comparable pcr cycle thresholds (c t s) (median, . , range, . - . vs. median . ; range, . - . , respectively; p = . ). all specimens tested negative by direct examination for pj, whereas were positive by real-time pcr (bal, n = ; sputa, n = , and ta, n = ); following stringent clinical, microbiological and imaging criteria ( table ) , pjp was deemed to be the most probable diagnosis in episodes occurring in unique patients. no histopathological confirmation of pjp was available for any patient. pcr c t values inversely correlate with fungal burden in the sample. which is higher in patients with pjp than in colonized individuals. here, overall, pj pcr c t s in specimens from patients with pjp tended to be lower than in pj carriers ( p = . ); when only bal fluid specimens were considered, the difference reached statistical significance (median, . ; range, . - . vs. median . ; range, . - . ; p = . ). this finding is likely related to use of more standardized procedures for bal fluid sampling. receiver operating characteristic (roc) curve analysis showed that a threshold c t value of . in bal specimens displayed a sensitivity of . % ( % ci, . - %) and a specificity of % ( % ci, . - %) for pjp diagnosis. a number of studies have established different c t s cut-offs for that purpose, [ ] [ ] [ ] [ ] . in our view, however, the variability in the performance of different pcr assays and sampling conditions, heterogeneity of patient populations, and in particular the lack of a pj international standard material for pcr result normalization precludes defining a consensus universal threshold nowadays. the absence of anti-pj prophylaxis, treatment with corticosteroids and serum ldh levels ≥ u/l have been shown to be associated with pjp. here, patients not undergoing anti-pj prophylaxis were more likely to display a clinically significant pj pcr result ( table ). in turn, roc curve analysis indicated that a cut-off ldh value ≥ u/l had a sensitivity of . % (ci %, . - %) and specificity of % ( % ci, . - . %) for pjp diagnosis. in univariate regression logistic models, serum ldh values ≥ u/l were associated with a clinically significant positive pcr pj result (or, . ; % ci, . - . ; p = . ). in contrast, corticosteroid use within the month before sampling was not different between the probability of pneumocystis jirovecii (pj) pneumonia (pjp) for each patient was retrospectively evaluated by an expert committee including infectious diseases and microbiology specialists at both centers, on the basis of (i) documented pj presence in respiratory specimens by microscopy; (ii) compatibility of clinical signs and symptoms (at least of the following: subtle onset of progressive dyspnea, pyrexia, nonproductive cough, hypoxaemia and chest pain), (iii) compatible (suggestive) radiological findings (chest radiograph and/or high-resolution computed tomographic scan detection of interstitial opacities and/or diffuse infiltration infiltrates); (iv) complete resolution of symptoms after a full course of anti-pjp treatment; (v) absence of alternative diagnosis. the efficacy of therapy was assessed on a daily basis. pjp was ruled out if real-time pcr for pj tested negative, or if clinical recovery occurred in the absence of pj-targeted antimicrobial therapy. pj colonization (carriage) was the most likely possibility when patients did not meet the above criteria and an alternate diagnosis was made. b frequencies were compared using the χ test (fisher exact test) for categorical variables. two-sided exact p values were reported and p values ≤ . were considered statistically significant. the data were analyzed with the spss (version . ) statistical package. c respiratory tract specimens were obtained following conventional procedures. specimens were examined for presence of ascus or trophic forms of pj by microscopy following blue toluidine, calcofluor white or grocott's methenamine silver staining. cytospin preparations were prepared from bal specimens for direct examination. sputa and ta samples were mixed v/v with sputasol (oxoid, uk) and vortexed for min. all samples were centrifuged at g for min, and the pellets were resuspended / in . % nacl for further processing. for real-time pcr, dna was extracted from μl of specimens using the qiaamp dna blood mini kit (qiagen, hilden, germany) on either qia symphony or ez- platforms (qiagen), following the manufacturer's instructions. at hcu, a commercially-available real-time pcr assay previously evaluated by others, the realcycler pjir kit r (progenie molecular, spain), which targets the mitochondrial large sub-unit of ribosomal (mtlsu) rna gene, was used according to the manufacturer's instructions ( http://www.progenie-molecular.com/pjir-u-in.pdf ). at hlf, the commercially-available pneumocystis jirovecii real time pcr detection. (certest biotech; zaragoza, spain), which also targets the large sub-unit of ribosomal (mtlsu) rna gene, was employed following the manufacturer instructions ( https://www.certest. es/wpontent/uploads/ / /viasure _ real _ time _ pcr _ pneumocystis _ jirovecii _ sp .pdf ). at both centers pcr were performed in the applied biosystems fast real-time pcr platform (applied biosystems, ca, usa). pcr results were reported as positive or negative. for positive samples, threshold cycle (c t ) values were also recorded. no standard curve was generated with a positive control for quantitative estimations. d antimicrobial prophylaxis for pjp was performed with trimethoprim-sulfamethoxazole (tmp/smx), one double-strength tablet ( mg tmp/ mg smx) given (in allogeneic hsct patients) or times a week with oral folic acid ( , ) . patients with suspicion of pjp according to the attending physician were treated with tmp/smx - mg/kg (tmp) - mg/kg (smx) per day for - weeks. e in all these cases, death was attributable to pjp. patients with clinically significant pj detection and pj carriers ( table ) . detection or recovery of other microbial agents (one or more) was documented in of the specimens testing positive by pj pcr ( table ). in line with a previous report, this microbiological finding was significantly less frequent ( p = . ) in specimens from patients with pjp than in colonized patients; in fact, microbial co-detection was inversely associated with pjp in univariate logistic regression models (or, . ; % ci, . - . ; p = . ). strengths of the current study are the following: (i) clinical categorization of pjp was based upon stringent criteria defined by a multidisciplinary team; (ii) only hematological patients were included; (iii) a comprehensive routine investigation of microbial causes of pneumonia other than pj was conducted; (iv) the experience of two centers was collected. in addition to its retrospective nature, our study also has some limitations: (i) we cannot completely rule out that some patients categorized as being pj carriers did in fact have pjp, as most of these patients received full courses of tmp/smx in combination with antimicrobials targeting other microbial agents. the lack of standardized criteria for pjp diagnosis makes clinical misclassification of patients a potential drawback in studies such as ours, particularly when no positive microscopy or histopathology findings are available; (ii) although we evaluated bal, bronchoalveolar lavage; pjp, pneumocysis jirovecii pneumonia; ta, tracheal aspirate. a as per our routine protocol, all specimens were examined by gram and acid-fast bacilli stain. samples were also examined for presence of respiratory viruses (rvs) using either the luminex xtag rvp fast assay (luminex molecular diagnostics, austin, tx,usa) at hcu, or the clart® pneumovir assay (genomica, coslada, spain) at both centers, as previously reported. semiquantitative (sputa) and quantitative (bal and ta) cultures for bacteria were performed on conventional media: bacterial loads > cfu/ml or > cfu/ml were deemed to be clinically relevant on bal fluids and ta samples, respectively. specimens were cultured on bcye-alpha agar, bd (becton dickinson) mgit® ( mycobacteria growth indicator tube)/lowenstein-jensen agar slants and sabouraud agar for recovery of legionella pneumophila, mycobacterium spp., and other fungal organisms, respectively. the platelia tm aspergillus ag kit (bio-rad, hercules, ca, usa) was used for quantitation of aspergillus spp. galactomannan in bal fluid and serum specimens. all bal fluid specimens underwent cytomegalovirus (cmv) pcr testing using the realtime cmv pcr assay (abbott molecular) at hcu or the cmv r-gene® assay (biomerieux) at hlf, as previously reported. over patients, only presumptively had pjp; (iii) two different commercially-available pcr assays were used across centers. nevertheless, we found them to yield rather comparable c t s. in summary, we found that a positive pj pcr result in respiratory specimens from transplant and non-transplant hematological patients with pneumonia frequently reflects colonization rather than infection; pcr c t values in bal fluids, serum ldh levels and lack of co-detection of other microorganisms potentially involved may be helpful in clinical categorization in the absence of positive by pj microcopy results. we have no conflict of interest to declare. dear editor , poller et al., in this journal, provided a useful consensus for use of personal protective equipment for managing high consequence infectious disease . although this was driven largely by recent ebola virus disease emergencies, we should remind your readers of the continuing problem of lassa fever (lf) in west africa. lf is a febrile infectious disease caused by lassa virus. the clinical presentation of the disease is nonspecific and includes fever, fatigue, hemorrhage, gastrointestinal symptoms, respiratory symptoms, and neurological symptoms . the observed case fatality rate among patients hospitalized with severe lf is - % , . the disease is mainly spread to humans through contamination with the urine or faeces of infected rats . human-to-human transmission can occur through contact with the body fluids of infected per-sons. therefore, health care workers are at high risk for infection when the standard precautions for infection prevention and control including appropriate personal protective equipment are inadequate . it is estimated that there are approximately , lf cases annually, resulting in approximately deaths in west african countries . in , nigeria had a large lf outbreak, and we previously reported epidemiological characteristics of the outbreak, analyzing data collected between january and may . however, information on laboratory-negative suspected cases was not enough to conduct a case-control study to fully determine the risk factors and clinical characteristics of the disease. nigeria had a lf outbreak in as well. here we report the epidemiological and clinical characteristics of the outbreak including case-control analysis against laboratory-negative suspected cases using data collected between st january and th october . from january to december , there were suspected cases, including laboratory-confirmed lf cases. in , there were suspected cases reported by th october, including laboratory-confirmed lf cases. details on the case definition, laboratory test, surveillance, and data collection have been described previously. of the confirmed lf cases, there were fatalities (case fatality rate, . %) in and fatalities (case fatality rate, . %) in . the number of laboratory-confirmed lf cases and positivity rate peaked in the dry season (january-march) in both and ( fig. (a) ). the largest number of laboratory-confirmed lf cases were reported from the neighboring edo and ondo states in both and ( fig. (b) ). there were laboratory-confirmed lf cases in states such as kebbi and zamfara that had no reported cases previously, in . during the study period, the detailed demographic and clinical information was collected for laboratory-confirmed lf cases (of cases, . %) and laboratory-negative suspected cases (of cases, . %). chi-square tests were conducted to compare the distribution of age, sex, and each symptom between the laboratory-confirmed lf cases and laboratory-negative suspected cases ( table ). the proportion of children was significantly lower in laboratory-confirmed lf cases compared with that in laboratory-negative suspected cases. the proportion of males was significantly higher in laboratory-confirmed lf cases than that in laboratory-negative suspected cases. fever was the most prevalent symptom in both laboratoryconfirmed lf cases and laboratory-negative suspected cases, followed by headache ( table ) . gastrointestinal symptoms, such as abdominal pain, vomiting, and diarrhea, were observed in more than % of laboratory-confirmed lf cases, whereas hemorrhaging was observed in . % of laboratory-confirmed lf cases. while the prevalence of face/neck edema was low even in laboratoryconfirmed lf cases ( . %), nonetheless, the odds ratio of having face/neck edema was . times high for laboratory-confirmed lf cases. we here reported the lf outbreak in - largest recorded in history. while previous studies have focused on laboratory-confirmed lf cases and mainly compared fatal cases and survived cases, , , our observation revealed the difference between laboratory-confirmed lf cases and laboratory-negative suspected cases. the age and sex distribution differed significantly between laboratory-confirmed lf cases and laboratory-negative suspected cases. fever, headache, and gastrointestinal symptoms were the most common symptoms in laboratory-confirmed lf cases, which are similar to those reported previously. , however, these symptoms were also prevalent in laboratory-negative suspected cases. clinical guidelines for lf state that edema in the face and neck is a specific sign of the disease. the present study found that the symptom had a significantly high odds ratio for confirmed lf although the prevalence of this symptom was low. unfortunately, we did not determine the differential diagnosis for the laboratory-negative suspected cases. laboratory tests for the differential diagnoses are now underway for the lf-negative samples collected during the outbreak. the results would provide us further insight for better clinical management of patients with febrile illnesses in lf-endemic areas. in addition to the standard precautions for infection prevention and control including appropriate personal protective equipment pointed out by poller et al., it is important to know epidemiological and clinical characteristics of high consequence infectious diseases such as lf. that would help healthcare workers and public health officers increase an index of suspicion of the diseases, further leading to better clinical management and surveillance. the authors have declared that no conflicts of interest exist. this work was partially supported by the leading initiative for excellent young researchers from the ministry of education , culture, sport, science & technology of japan and the japan society for the promotion of science (grant number, ). the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. these authors contributed equally to this article. accepted december available online january https://doi.org/ . /j.jinf. . . © the british infection association. published by elsevier ltd. all rights reserved. recently, several studies in this journal have demonstrated the threat of animal-derived viruses to humans. [ ] [ ] [ ] since , an increase in human pseudorabies virus (prv) infection cases has been reported in china, indicating a new animal-derived virus threat to human health. porcine pseudorabies (pr), also known as aujeszky's disease, is one of the most economically important viral diseases in pigs globally. its causative agent is prv, which is classified into the genus varicellovirus of subfamily alphaherpesvirinae , family herpesviridae . prv is almost always fatal in newborn piglets, is frequently accompanied by neurological symptoms, and may cause abortions and/or stillbirths in pregnant sows. prv primarily infects members of the suidae family and can also infect other domestic and wild mammals, including horses, cattle, sheep, goats, dogs, cats, etc. currently, vaccination is the most effective strategy for pr prevention and control in pigs worldwide. in china, prv infections in pigs were first recorded in . in the s, an inactivated vaccine consisting of the bartha-k vaccine strain was imported into china. since then, this vaccine has been widely used in pig vaccination for pr prevention and control. before , no large pr outbreaks were reported in pigs in china. however, after late , novel prv wild-type variants emerged in nearly all regions of china and affected a number of swine herds vaccinated regularly with the bartha-k vaccine, resulting in significant economic losses. subsequent animal experiments indicated that the bartha-k vaccine could not provide complete protection for pigs against a challenge with novel prv wild-type variants in china. for control and eradication of pr, the disease was listed in the "mid-and long-term animal disease prevention and control program in china ( - )" by the chinese government, with the aim of eliminating pr in china by ( http://www.gov.cn/zwgk/ - / /content _ .htm ). however, vaccination for prv is still voluntary and not required in china. a nationwide epidemiological investigation in demonstrated a high prevalence of . % of prv among swine herds in china. humans were previously regarded as refractory for prv infection, although serological prv antibody positivity was found in three cases. in , the first human prv infection case with direct molecular evidence was reported in china (case , table ). in this case, the eyes of a -year-old woman were directly exposed to sewage on a hog farm. in the following two weeks, symptoms of fever, headache, coma, and endophthalmitis were observed in the patient. next-generation sequencing (ngs) indicated that prv dna was detected in her vitreous humor samples but not in her cerebrospinal fluid (csf). after surgery, the patient was discharged, but her vision remained impaired. in a subsequent study, zhao et al. table clinical characteristics and other information on the twelve human prv infection cases in china. analyzed csf samples from four patients with encephalitis of unknown etiology using ngs (cases - , table ) and found molecular evidence of prv infection. in addition, retinitis and blindness was observed in two cases (cases , , table ), and the patient in case died. the occupation of the four patients was all associated with pork production/sale/cooking. in , six other human prv infection cases involving encephalitis were reported in china, and all patients were pork/pig handlers or veterinarians. [ ] [ ] [ ] it was noted that all patients still suffered from various sequelae after discharge, except for in one case where the patient died. increasing reports on human prv infection cases in china have recently indicated that prv poses a significant threat to public health in china, especially in people in close contact with sick pigs and/or related pork products/contaminants. to reduce the risk of prv infection in susceptible workers, it is necessary to promulgate relevant policies by the chinese government to promote pr vaccine development to protect pigs from infection with novel prv wild-type variants currently circulating in china. in addition, relevant policies should be updated by the chinese government to monitor vaccination status and virus variation in pigs nationwide. moreover, it seems that prv can infect humans via injury to the skin or eyes. until now, no effective drugs to prevent the progression of the disease caused by prv infection have been reported. therefore, it is necessary to improve biosafety and self-protection awareness in susceptible populations that have contact with sick pigs and work in jobs related to handling pork products/contaminants. promoting drug development for curing prv-related disease in infected patients may also help reduce the currently increasing threat of prv to human health in china. all authors declare that they have no competing interests. dear editor, the emergence and spread of gram-negative bacteria, for example, klebsiella pneumoniae , co-producing carbapenemases and mobilized colistin resistance ( mcr ) genes limit our choice for treating multidrug-resistant infections, posing significant threats to public health. herein, we reported the discovery of mcr- gene in k. pneumoniae strains isolated from patients in eight european countries, including belgium ( n = ), denmark ( n = ), montenegro ( n = ), poland ( n = ), romania ( n = ), serbia ( n = ), slovenia ( n = ), and spain ( n = ). notably, the co-existence of mcr- and the carbapenemase-encoding genes, ndm- , vim- , and oxa- were confirmed in k. pneumoniae isolates of human origin. phylogenetic analysis suggested that mcr- -carrying k. pneumoniae isolates, including carbapenem-resistant and five susceptible k. pneumoniae strains, show a highly geographically clustered pattern. genetic environment analysis revealed the presence of insertion element is , is or a cupin fold metalloprotein, wbuc, in the mcr- flanking. taken together, these findings indicated that mcr- has existed for a long time and already spread among crkp isolates of human origin in europe since , further increasing the significant threat of public health through either the nosocomial spread or environmental routes. the mobilized colistin resistance ( mcr ) gene mcr- was detected in human gut microbiomes, which has been disseminating across three continents, including asia, europe and america, recently published in the journal of infection. the rapid increase in carbapenem resistance among gram-negative bacteria worldwide has greatly compromised the efficacy of carbapenem antibiotics, which has gotten renewed attention to the importance of polymyxin antibiotics for multidrug-resistant (mdr) infections. recently, sophia david and colleagues reported the epidemic of carbapenem-resistant klebsiella pneumoniae (crkp) in europe, which raised concern that mobile carbapenemase resistance determinants were widely spread in european hospital settings, and inter-hospital spread is far more frequent within, rather than between, countries. however, limited information regarding the co-occurrence of carbapenemases and mcr genes in the klebsiella pneumoniae ( k. pneumoniae ) isolates have been provided. plasmid-mediated resistance genes mcr as well as tet (x /x ) have been widespread in bacterial species of animal, human, and environment origin as well as human and animal gut microbiomes worldwide, where is a huge arg reservoir with a high horizontal gene transfer possibility. , - several studies - illustrated that the newly described mcr- has spread beyond the united states into europe and asia, and into other enterobacteriaceae species. of clinical concern is the inevitable spread of a plasmid harboring the mcr- gene into a crkp isolate, which has been listed by the world health organization as a critical priority antibiotic-resistant bacterial pathogen for which new antibiotics are urgently needed. in response to this potential clinical problem, we download > k. pneumoniae genomes isolated from hospitals in european countries and the , complete bacterial genome sequence (accessed july ), and explored the distribution of plasmid-mediated resistance genes mcr and tet (x /x ). we are surprised to find that the complete mcr- gene (nucleotide = %) was present in k. pneumoniae isolates of k. pneumoniae strains from belgium ( n = ), denmark ( n = ), montenegro ( n = ), poland ( n = ), romania ( n = ), serbia ( n = ), slovenia ( n = ), and spain ( n = ) (table s ). additionally, of the k. pneumoniae isolates of human origin were crkp strains and only five were carbapenem-susceptive isolates (table s ). as reported, these mcr- -harbouring strains were isolated from patients in europe between and . these results suggest that mcr- gene might have been presented in europe for a long time and already spread to the crkp isolates, which is a major cause of both hospital-and community-acquired infections. to further analyze these mcr- -positive k. pneumoniae isolates, the resistome of the draft genome was analyzed using the comprehensive antibiotic resistance database. interestingly, the mcr- gene was co-existed with various carbapenemase-encoding genes: in eleven isolates with ndm- , eight with vim- , and two with oxa- ( fig. (a) ). it should be noted that the mcr- -and ndm- -carrying isolates were distributed in denmark ( n = ), montenegro ( n = ), romania ( n = ), and serbia ( n = ), as well as several other beta-lactam resistance determinants (for example, tem- , cmy- , oxa- and shv- ) ( fig. (a) and table s ). moreover, the mcr- -and vim- -harbouring isolates were dominant in spain ( n = ) and slovenia ( n = ), as well as two beta-lactamase-encoding genes (non-carbapenemases) (ctx-m- and shv- ) ( fig. (a) and table s ). it is worrying that a crkp isolate from spain in was carrying mcr- , vim- , and oxa- genes simultaneously. the presence of mcr- in crkp isolates from patients is of critical importance as mcr- could be present in hospital-borne outbreaks cre strains in the future. from whole-genome shotgun (wgs) data of the mcr- -positive k. pneumoniae isolates, sequences types (sts) were extracted and assigned to nine different types, i.e. , , , , , , , , , and ( fig. (a) ). phylogenetic analysis suggested that mcr- -carrying k. pneumoniae isolates show a highly geographical clustering pattern ( fig. (a) ). isolates from patients in the same hospital were clustered into one clade, for example, in spain and montenegro. overall, the k. pneumoniae isolates from different countries were genetically diverse, suggesting that the mcr- -positive k. pneumoniae isolates were also genetically diverse and that mcr- could disseminate among different k. pneumoniae isolates, mainly by nosocomial transmission. nowadays, all known mcr genes have been detected in various gram-negative bacterial species, whereas a small number of studies have shown the presence of mcr- , mcr- , mcr- , and mcr- in k. pneumoniae isolates from animal and human origin at relatively low detection rate. - the presence of mcr- in the crkp isolates indicated that this novel mcr gene may already be widely spread among k. pneumoniae isolates of human origin in europe. we subsequently searched mcr- gene in , complete bacterial genome sequence and ncbi-nr database ( october ) in the ncbi, to fully understand the prevalence of mcr- gene in klebsiella species isolates. interestingly, the mcr- gene (identity > % and % query coverage) was present in various bacterial genomes, including three klebsiella species isolates consisting of k. pneumoniae ( n = ), k. quasipneumoniae ( n = ), and k. oxytoca ( n = ) (table s ) . therefore, further studies focusing on the epidemiology and transmission mechanism of mcr genes, in particular mcr- in klebsiella species of human origin are warranted to better understand the public health threat of emergence of antibiotic resistance among clinical k. pneumoniae . contigs carrying mcr- in k. pneumoniae isolates could be classified into two groups (for example, gca_ . and gca_ . ) (table s ) . genetic environments analysis indicated that the presence of insertion element is and wbuc (a cupin fold metalloprotein), in the mcr- (gca_ . , ∼ kb) upstream and downstream flanking, respectively, similar to (identity > %) the plasmid sequences of pme- a, pctxm _ , and pmrvim , and contigs from of e. coli isolate a and nz_naan from salmonella ( fig. (b) ). additionally, mcr- in another contig ∼ . kb was in the upstream of two insertion element is and is , as well as a beta-lactamase-encoding resistance gene ctx-m- , which similar to the plasmid sequence of pmrvim . we did not detect the downstream regulatory genes (qsec and qseb) found in the isolates that harbor mcr- . , moreover, we were unable to determine whether a complete is element is upstream due to a short mcr- -bearing contig that is available for comparison ( fig. (b) ). therefore, a long-read sequencing coupled with a hybrid assembly method is needed to fully evaluate and monitor the transfer and development of args, especially mcr- among crkp isolates. although two unique plasmid-mediated tigecycline resistance genes firstly discovered in bacteria of animal origin in china and subsequently identified in many bacterial isolates of human, animal and environment origin, including klebsiella species, as well as human and animal gut microbiomes, , , none of them was detected in the k. pneumoniae strains in europe. in summary, we reported the discovery of mcr- gene in clinical k. pneumoniae strains of human origin in eight european countries. importantly, the mcr- gene was co-existed with different carbapenemase-encoding genes in the same strains. the spread of mcr- , ndm- , vim- , and oxa- and other beta-lactam resistance determinants (non-carbapenemase) carrying by crkp appears likely to be by plasmid dissemination, as the genes identified in isolates belonging to a diverse set of sts distributed in different hospitals in europe. it is noteworthy that all these mcr- -positive crkp strains were isolated between and , highlighting an earlier presence of mcr- among crkp around the world than previously known. these findings raise the likelihood of ongoing undetected mcr- gene spread among cre strains. therefore, further study is urgently needed to understand the prevalence and dissemination of mcr- , especially in cre and crkp strains, and effective measures should be taken to control its spread. g.f.g. designed the study. y.n.w. and f.l. collected and downloaded the datasets. y.n.w., f.l., y.f.h., b.l.z., g.p.z., and g.f.g. analyzed and interpreted the data. y.n.w. and g.f.g. wrote the draft of the manuscript. all authors discussed, reviewed and approved the final report. supplementary information is available for this paper. correspondence and requests for materials should be addressed to g.f.g. the authors declare no competing interests. the interesting systematic review by amin-chowdhury and colleagues provides information about outbreaks of severe pneumococcal disease (spd) in closed settings that occurred in the conjugate vaccines era . it shows that vaccine-type spd outbreaks are still occurring and it highlights the lack of consensus on how to manage such outbreaks. in the following, we will describe how we managed a recent outbreak of spd in norway. in march , møre and romsdal hospital trust notified the norwegian institute of public health (niph) about a cluster of spd amongst men working in shipyards in møre and romsdal county. serotype data from niph were available for nine of the cases -all were serotype . the majority of cases had been working at one specific shipyard. municipal medical officers (mmo), the norwegian labour inspection authority (nlia), and niph formed a multidisciplinary outbreak team to investigate and control the outbreak. we formed specific case definitions: each case had to have resided in møre and romsdal county in the period from . january onwards and: confirmed : had invasive pneumococcal disease (ipd) with serotype isolated from a normally sterile site. probable : worked at the specific shipyard and had a clinical presentation compatible with lower respiratory tract infection or ipd, but without microbiological confirmation or serotype isolated from a non-sterile medium (e.g. nasopharyngeal swab or sputum culture). we identified cases, ten confirmed and ten probable in the period between . january and . april ( fig. ). all available isolates were serotype ( confirmed, probable) and were susceptible to penicillin. fifteen isolates were sequence type (st) , while two were a single locus variant of , st , . all cases were men between and years, with a mean age of years. fifteen were hospitalized. four were norwegian citizens, the remaining came from other european countries. seven cases smoked. one case had an underlying medical risk condition. immunization history against pneumococci were unknown for all. the cases had several professions; mostly related to interior outfitting and metal welding. approximately individuals worked at the shipyard in the time period. many of them lived in temporary accommodation. at an on-site inspection of the shipyard, nlia observed a polluted atmospheric work environment and little use of personal protective equipment. several measures were put in place to control the outbreak, including information and advice to raise symptom awareness and to reinforce hand and respiratory hygiene, vaccination and occupational corrections. local medical clinics and hospital were alerted about the outbreak and advised to have a low threshold to admit and treat suspected cases. mmo held information meetings with shift leaders, and written information about spd in several languages was distributed to workers to increase spd awareness. intensified hygiene measures were implemented at the ship yard and housing quarters. nlia ordered immediate occupational corrections related to controlling the atmospheric work environment. niph recommended vaccination with the -valent conjugate vaccine (pcv ) to interrupt transmission and prevent disease. both the pcv and the -valent polysaccharide vaccine provide protection against serotype , but pcv was preferred as this may also affect colonization. as several work tasks were conducted in parallel process in confined spaces with suboptimal ventilation, we were unable to identify a single target group for vaccination. hence, the shipyard offered vaccination to all workers. occupational health service promptly vaccinated all workers during a four-day period. contrary to the majority of studies included in the systematic review, niph did not recommend chemoprophylaxis. as the workers were otherwise healthy (i.e. no high risk group like old age, immunocompromising conditions etc.), and since it was impossible to target a specific group of workers, niph deemed it undesirable to distribute antibiotics to asymptomatic workers, with the possibility of inducing antimicrobial resistance and possible side effects. due to high turnover of personnel it was not possible to calculate an attack rate. we did not find any new cases after control measures were implemented. no deaths have been reported in relation to the outbreak. this outbreak closely resembles one of the outbreaks described in the systematic review; between april and june , an outbreak with serotype , st occurred at a shipyard in belfast . we are also aware of an outbreak this fall, , at a shipyard in finland with serotype (st ), and f . although welders are a known risk group for spd, in all these three outbreaks, people who worked closely alongside welders were also infected. in addition to exposure to welding fumes, the crammed and poorly ventilated working conditions, and possibly housing conditions, may have increased the risk of developing spd and facilitated the transmission of pneumococci in this closed setting. overall, this norwegian outbreak extends the knowledge about how to manage and control outbreaks of spd in closed settings. none. in this journal brunet and colleagues discussed reactivation of latent infections in the context of chronic disease, solid organ transplantation or long-term immunosuppressive treatment. we recently observed the reactivation of leishmania infection in a -year-old patient receiving methotrexate for psoriasis, who was diagnosed with visceral leishmaniasis (vl) showing a mucocutaneous involvement. we analyzed the epidemiologic and clinical characteristics of all cases of leishmaniasis in patients with psoriasis found through a review of the literature. our patient was admitted into the infectious disease unit of paolo giaccone hospital, in palermo, with a painless and ulcerated lesion onto the oral mucosa ( fig. a ) , two nodular ulcerated lesions on the right knee and another one on instep of the right foot appeared one month before ( fig. b ) . the patient did not travel outside italy during the last year. he had been suffering from lowgrade fever in the last month. considering the above findings leishmaniasis was suspected and a needle aspiration of oral and cutaneous lesions was arranged in order to perform microscopy and leishmania-pcr, which were positive for leishmania. laboratory tests exhibited: wbc /mmc, hb . g/dl, c reactive protein, . mg/l; positive serology for leishmania (igg / ) and positive leishmania-pcr test on peripheral blood. abdominal us examination revealed splenomegaly ( cm); methotrexate was suspended and liposomal amphotericin b, mg/kg per day for days, followed by two further administrations two weeks later was started. cutaneous and mucosal lesions improved at the end of the first days of therapy and completely vanished after two further administrations, days from the beginning of treatment. leishmania-pcr on peripheral blood after days of therapy was negative. table shows the literature data about characteristics, therapy and outcome of patients with psoriasis and leishmaniasis. leishmaniasis is a vector-born chronic infectious disease caused by protozoa of the genus leishmania and transmitted to humans by the bite of phlebotomine sandflies. in europe, the mediterranean countries are the most affected areas. leishmania parasite establishes chronic intracellular parasitism, survives for an infected person's lifetime and, in the event of major immune deficiency, may be reactivated from sites of latency. leishmaniasis can present with a spectrum of clinical manifestations and three patterns of infection are described: cutaneous (cl), mucosal or mucocutaneous (ml or mcl) and visceral leishmaniasis (vl). the infecting species of leishmania is very important in determining the clinical manifestations and the host immune response is crucial in determining the clinical outcome of infection . today, non-hiv related immunosuppressive conditions are becoming increasingly prevalent, mainly because of better medical care of patients with chronic illnesses and the therapeutic use of immunosuppressive drugs. in the field of rheumatology, leishmaniasis has been reported in association with the use of various immunosuppressive drugs. the introduction of tumor necrosis factor-alpha (tnf-α) antagonist drugs has received much attention recently and several cases of vl have been reported in rheumatic patients who do anti-tnf α drugs. psoriasis is a chronic inflammatory autoimmune disease affecting - % of the world's population and characterized by an aberrant hyper-proliferation of keratinocytes. the pathogenesis of psoriasis is complex. genetic susceptibility, environmental triggering factors and an over-reaction of local innate immune response initiate inflammation. subsequent involvement of adaptive immune response with production of th cytokines, chemokines and growth factors lead to epidermal hyperplasia. recently, a functional role of interleukin- -producing t helper cells (th ) in psoriasis has been suggested by their reduction during successful anti-tnf treatment. it is also known that th lymphocytes play an essential role in protecting against intracellular protozoa and in the successful clearance of leishmania by strengthening the th response. in view of this, it could be argued that psoriasis may represent a protective factor for leishmania infection. indeed, in our review we did not found any case of leishmaniasis in psoriatic subjects who were not under immunosuppressive therapies. biological agents, which are powerful immunosuppressive drugs, have been more and more used in rheumatic patients and leishmania infections have been reported among anti-tnf-agents users. recently maritati et al. found higher prevalence of subclinical leishmaniasis in patients with inflammatory rheumatic diseases receiving biological drugs than those treated with other immunosuppressive drugs. however, leishmaniasis has also been reported in psoriatic patients not receiving biological drugs, as occurred to our patient ( table ) . diagnosis of cl in psoriatic patients is challenging, as it mimics many other infections or a flare-up of psoriasis itself that can lead to ineffective and harmful changes of therapy. immunosuppressive therapies cause atypical manifestations of leishmaniasis with large lesions spread over large cutaneous areas and associated to a possible mucosal involvement. ml by l. infantum is very rare and only sporadically described in patients receiving powerful immunosuppressive therapies or in hiv-coinfected patients. mcl is mostly observed in latin america where l. braziliensis accounts for most cases, but l. panamensis, l. guyanensis, and l. amazonensis have also been implicated. only rarely cutaneous lesions extend to areas of skin distant from the mucosa involved, as in our case in which two lesions on the foot and knee were associated with the oral lesion. in the context of impaired immunity, it is also advisable to rule out vl by pcr-leismania on peripheral blood so as to establish the most appropriate therapy: intralesional or intravenous. finally, there is no agreement on appropriate screening for leishmaniasis before immunosuppressive treatments and on the strategy to be followed after the diagnosis of leishmaniasis in rheumatic patients taking immunosuppressive drugs. molecular methods are highly sensitive and specific tools for the diagnosis of visceral leishmaniasis and a screening with leishmania-pcr in immunosuppressed patients living in endemic areas could be useful to identify patients at highest risk of reactivation. specific leishmaniasis treatment followed by suspension of the immunosuppressive therapy was adopted by most of the authors. overall even if the treatment response is not as good as seen in the immunocompetent population, our review reports a good outcome in all cases and patients remained relapse-free without maintenance therapy and despite the ongoing use of immunosuppressive medication. in conclusion physicians must be alert to the possibility of development of leishmaniasis in immunosuppressed rheumatic patients. adequate screening for vl should be incorporated into the list of baseline studies to carry out before initiating biologic therapies, at least in endemic areas. the authors declare that there is no conflict of interest. as demonstrated in several studies in journal of infection , herpesviruses pose an increasing threat to human health. [ ] [ ] [ ] according to international committee on taxonomy of viruses (ictv), equine herpesviruses (ehvs) belong to the family herpesviridae . until now, a total of ehv species types have been determined in equines, viz. ehv -ehv . among them, ehv and ehv are the most relevant herpesviruses affecting equines. both ehv and ehv infection are associated with upper respiratory tract disease, but only ehv infection could cause abortion and myeloencephalitis. ehv and ehv are prevalent in equines on all continents and have considerable economic impact on the horse industry. in china, the number of equines is very large, reaching to be ∼ . million in ( http://www.stats.gov.cn/tjsj/zxfb/ ). ehv infection in equines was first reported in china in , and the epidemiological investigation since then indicated ehv was prevalent in the equine population in all the studied provinces in mainland china, with a seroprevalence ranging % − %. [ ] [ ] [ ] vaccination is commonly used to prevent and control ehv. however, china has not developed a commercially available ehv vaccine so far. ehv vaccine has a limited market application potential in china currently. due to the lack of relevant knowledge on ehv, most of the chinese horse owners always erroneously identified it as other common pathogen of equine respiratory diseases, and didn't realize its potential threat to equine health and reproduction. although the number of equines in china is large, most of them are labor/farming horses. to the best of our knowledge, even for racehorses, vaccination with ehv vaccine has not been performed in mainland china. considering the wide distribution and high prevalence of ehv in china, it is urgently to popularize knowledge on ehv in horse owners and promote market application prospects of ehv vaccine. in china, few veterinary researchers are currently investigating equine virus, including ehv. this is mainly caused by the change of equines' historical role. in the last century, a great number of equines were used for military in china. however, there is only one military equine farm in mainland china at present. considering a more important economic role of other domestic animals (e.g., pigs, chickens, and cattle) compared with equines, investigating equine virus (including ehv) is not a priority in the related guide policies issued by the chinese government. though epidemiological studies on ehv in china are limited, it still could be concluded that epidemic status of ehv is very complicated in china, which increases the difficulty in ehv vaccine development. in most provinces, ehv and ehv were co-circulating in equines with a high seroprevalence. until now, a total of ehv strains have been isolated from tissue samples of aborted equine fetuses ( from farming horses in northeast china in , from asian wild horses in western china in , from farming horses in western china in ). , in addition, a novel ehv strain was isolated from one horse with serious respiratory disease in northern china in . recently, our laboratory firstly determined the molecule evinces for ehv and ehv in racehorses in sothern china (data not shown). however, a more large-scale and surveillance of ehv in equines is necessary to fully understand epidemic status of ehv in china, which could establish a foundation for updating the composition of ehv vaccine developed in china in future. in other countries, much effort has been made to develop ehv vaccine, and modified-live and inactivated virus vaccines have been registered for sale. before an ehv vaccine is developed successfully in china by itself, it is necessary to vaccinate the susceptible equine population with an ehv vaccine commercially available from other countries to prevent and control ehv in china. however, a well-designed case-control animal challenge study still needs to estimate the protective efficacy of different vaccines against the field prevalent ehv strains in china. all authors declare that they have no competing interests. a recent review article on the treatment of hepatitis c with directly-acting antiviral (daa) drugs, makes numerous recommendations for baseline drug resistance testing. in our local practice, we have been performing baseline drug resistance testing for some years now, prior to the publication of these guidelines. we present a recent retrospective hcv kinetics analysis of these patients' changing viral loads in response to daa therapy below. such studies have been used previously to compare viral suppressive responses in different hcv genotypes and treatment regimens. , the patients were a mixture of treatment-naive and treatment-experienced (including with interferon-based, ns protease inhibitor-based and daa-based regimens) cases. the current standard of care for hepatitis (hcv) patients is a combination of direct acting antivirals (daas), for which there are three different hcv viral protein targets (ns , ns a and ns b). table ns , ns a, ns b resistance associated substitutions (ras), by hcv genotype, found in this patient cohort at baseline drug resistance testing (viral sequencing performed at imperial college, london, uk). the patients included a mixture of treatment-naïve and treatment experienced (i.e. interferon-based, ns protease inhibitor-based and more recent daa-based regimens) cases. resistance associated substitution (ras) by hcv genotype treatment with daas cure the vast majority of hcv-infected patients, with oral regimens having > % efficacy in most patient groups. , , treatment failure currently affects approximately % of treated patients and is often associated with the selection of resistance associated substitutions (ras). we performed hcv drug resistance testing both retrospectively (following treatment failures) and prospectively (prior to treatment) in our cohort of hcv genotype (g) - -infected patients, during march -june . viral extraction, pcr and sequencing were performed at imperial college, using qiagen viral rna mini kits (qiagen pn: , qiagen ltd., manchester, uk), and inhouse pcr and sanger sequencing methods on an abi prism -avant genetic analyser (thermo fischer scientific, loughborough, uk). the prediction of hcv genotype and drug sensitivities is derived from the geno pheno algorithm [ www.geno pheno.org ]. treatment regimens used during this period complied with contemporaneous nhs rate cards: for non-cirrhotic or compensated cirrhotic patients: g -treatment-naive: omb/par/rit + das + r; g -treatment-experienced: elb/grz + /-r; g -treatmentnaive/experienced: gle/pib; g -treatment-naive/experienced: gle/ pib; g -decompensated cirrhotic patients sof/led + r; g /g decompensated cirrhotic patients: sof/vel + r. we assessed the impact of any ras across g -g on hcv rna kinetics by analysing viral load (realtime hcv viral load, abbott m , abbott molecular uk, maidenhead, england) decline rates. we applied linear mixed regression to model the viral loads and assumed a linear decline (log scale) over time, using sas statistical software (sas institute inc., nc, usa). in this cohort of patients (n: g = , g = , g = ), hcv ras were found as shown in table . hcv rna viral load decline rates were found to be similar and not statistically different ( p = . ) at: − log and − . log per month, respectively, for g and g /g ( fig. ). this suggests that these viral load decline rates were similar across g -g infections despite baseline differences in viral load, ras profile, or a history of any previous treatment (i.e. interferon-based, older ns protease inhibitor-based, or more recent daa regimens). these results demonstrate similar hcv rna clearance efficacies of the various daa treatment regimens for g -g , in this patient cohort. although other studies on hcv kinetics have been published, they do not usually compare multiple hcv genotypes. similar studies on patients infected with g - viruses, and/or undergoing other daa treatment or retreatment combinations, , will be with great interest we have read the report of zhang et al. concerning the increased susceptibility to pertussis in chinese adults at childbearing age, as determined in a comparative seroprevalence study using samples collected from to . the authors describe that about % of the individuals had pt-igg antibodies, which is indicative of a recent infection. in the adults - years of age, . % subjects had undetectable pt-igg antibodies in but . % in / . it is well known that adolescents and adults have become the reservoir of pertussis and an important source of transmission to vulnerable infants. bordetella pertussis is commonly associated with atypical pneumonia as determined in hospitalized children. several seroprevalence studies conducted in different regions of china indicate that the incidence of pertussis is most likely underestimated. , this may be due to the use of insensitive diagnostics. at present, the diagnosis of pertussis in china is mainly based on culture. however, both the cdc and the world health organization (who) use pcr as the gold standard for diagnosis, in addition to culture. oropharyngeal or nasopharyngeal swabs were obtained from , inpatients aged between days and years of age with clinical suspicion of pertussis, enrolled from march to february in shenzhen children's hospital. more than % of all patients were younger than months of age. the hospitalized patients included , males and females (sex ratio, . ). all patients recovered after the treatment. a real time pcr assay targeting ptxa-pr was used to detect b. pertussis . of the , samples, ( . %) tested positive for b. pertussis by rt-pcr. our results indicate that despite vaccination pertussis remains a major health problem in china, since the prevalence of infection by b. pertussis in hospitalized children was high. the majority of patients were admitted because of pneumonia. the detection rate in hospitalized patients was lower than the rates reported earlier in shanghai and ji'nan. , this may be due to lower number of samples collected in these studies and due to the use of serology or culture methods. the overall prevalence rates were . % and . %, respectively. however, b. pertussis infection in female patients was significantly higher than in male patients (x = . , p < . ). this has earlier been reported by the ecdc and haberling et al. and may point to a genetic association with susceptibility to b. pertussis . the detection rates were dependent on age in patients (x = . , p < . ). the prevalence decreased with age: . % newborns, . % in infants, . % in toddlers, . % in (pre-) schoolers ( fig. ) . the high vulnerability of newborns and young infants for b. pertussis infection may be related to a combination of insufficient herd immunity and suboptimal protection against b. pertussis infection in children too young to be fully vaccinated. since vaccination rates in infants are already at %, it will be difficult to improve this further. therefore, other measures must be considered, including booster vaccination at pre-school age and vaccination during pregnancy. because young infants are mainly cared for by mothers and other adults, the most important cause of infection with b. pertussis is their close contact with parents and siblings. in general, b. pertussis was detected more often during seasonal changes, especially from late summer to early autumn. in hospitalized children the number of b. pertussis infections increased in march and september as compared to other months ( fig. ) . the seasonal infection rates were . % in spring, . % in summer, . % in autumn and . % in winter, respectively. the prevalence in the winter season was lower but not statistically different than in other seasons (x = . , p = . ). in this study, we used real-time pcr, the most accurate method to detect b. pertussis . the detection rate may be significantly lower than the actual level, because oropharyngeal samples in most patients were collected instead of nasopharyngeal samples, and the pcr target gene was ptxa-pr instead of is . is is present in high-copy numbers in b. pertussis whereas ptxa-pr is a single-copy target. however, the ptxa-pr pcr is more specific and will not detect b. parapertussis , which contributes to more than % of pertussis cases. many studies have shown that adolescents and adults with b. pertussis infections, causing chronic cough, are an important reservoir for transmission, putting newborns at high risk. maternal pertussis immunization prevents infant pertussis, as recently shown by amirthalingam et al. vaccine effectiveness against infant deaths was estimated at %, and disease incidence in infants < months of age has remained low. according to our results, vaccination of pregnant women and adults, especially those in close contact with infants and young children, may help to prevent pertussis in infants and young children in china. the authors have declared that no competing interests exist. this study was supported by the sanming project of medicine in shenzhen ( szsm ) and by the shenzhen science and technology project ( jcyj ). tang and colleagues reported in this journal their experience with covid- disease , the outbreak of which began in december in wuhan, hubei province, china , with spread to additional countries - as of the st february . here we report the clinical features and outcome of the first two cases of disease caused by sars-cov- infection in the united kingdom (uk) -the first imported and the second associated with probable person-toperson transmission within the uk. public health management will be reported separately. the index case (a) entered the uk on / / from hubei province in china. initially asymptomatic, this individual, a year-old female with no past medical history and on no regular medications, developed symptoms of fever and malaise on / / , accompanied by sore throat and dry cough. she had travelled with her partner and reported no infectious contacts prior to travel. on / / , a close household contact of the index case, a resident of the uk, developed symptoms of fever ( . °c), followed the next day by diffuse myalgia and a dry cough. this patient (case b) is a previously fit and well year-old male. he had returned to the uk from hubei province on / / . case b promptly sought advice via the national health service (nhs) self-referral service nhs , and he and case a were assessed as being possibly at risk of covid- , and were admitted to the regional infectious diseases unit at castle hill hospital, hull university teaching hospitals for isolation, assessment and diagnostic sampling. they were managed in separate negative pressure cubicles with anterooms. nursing and medical staff donned personal protective equipment (ppe) as recommended by public health england (phe). the clinical observations of each of the patients, together with their initial blood tests, are shown in table . ( fig. ) . clinical examination findings were unremarkable. initial investigations revealed only mild lymphopenia and elevation of crp, with mild neutrophilia in case b. periodic fever of - . °c was observed in case b until d of admission. repeat blood tests in this individual on d demonstrated mild acute kidney injury (aki, serum creatinine μmol/l). the aki was thought most likely due to dehydration, and resolved within h with administration of intravenous infusion of crystalloid at ml/h. cxr was normal. empirical oral antibiotic therapy (co-amoxyclav / mg p.o. t.d.s.) was administered on d , to cover the possibility of secondary bacterial infection, but was subsequently discontinued. symptoms resolved in case a by d and in case b by d of admission. pcr testing of sars-cov- from nose and throat swabs taken daily was negative from d onwards in case a and from d in case b (throat swabs from this individual were negative throughout). there was no clinical indication for the use of experimental antiviral therapies. patients were deisolated according to current phe guidance, based on complete resolution of symptoms and two sequential negative respiratory pcr tests at least h apart. rooms were decontaminated with . % hypochlorite followed by uv light treatment. the contact of these individuals remained asymptomatic throughout the days incubation period but was isolated as a precaution and to be close to family these first cases of sars-cov- are informative for clinicians caring for suspected and confirmed cases in the uk and elsewhere. reassuringly, illness in both individuals was relatively mild and short-lived, with no evidence of parenchymal lung disease (reflected by normal oxygenation and the absence of radiological infiltrates) or of the late-stage deterioration that has been reported in case series , possibly due to the absence of comorbidities. experimental antiviral therapeutic options for severe disease were not considered necessary given the mild clinical nature of the illness. clinical illness correlated with the presence of viral rna in upper airway samples ( fig. ) , with no evidence of prolonged asymptomatic shedding, although discordance between nose and throat samples in case b highlights the need to sample both areas. it was reasonably assumed that the source of infection in case b was close contact with symptomatic case a, given that the time from travel to china to onset of symptoms in case b was days, although this cannot be proven. based on this assumption, the period from exposure to disease onset appeared short, at approximately h, consistent with recent reports of the incubation period of sars-cov- . co-occurrence of respiratory viral infection, as we observed in case b with rhinovirus, has been described in the context of sars-cov- ( https://www.medrxiv.org/ content/ . / . . . v ) as it has with many other respiratory viruses spread by similar routes, and may have contributed to the increased symptomatology in case b. interestingly the partner of case a, who was a close household contact, remained asymptomatic throughout and had negative tests for sars-cov- shedding. it will be of interest to investigate the serological responses in this individual to ascertain evidence of subclinical infection. isolation, minimisation of contacts and use of appropriate ppe is a cornerstone of management of high consequence respiratory viral infection. in the cases reported here, phe recommendations for ppe were followed and there were no breeches in ppe or nosocomial transmission. this should provide reassurance to healthcare workers managing patients with suspected covid- in the uk that current ppe is both feasible and effective. the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. dear editor , as reported in this journal and elsewhere, an outbreak of atypical pneumonia caused by the zoonotic novel coronavirus (sars-cov- ) is on-going in china and has spread to the world. as of feb , ( : , gmt + ), there have been , confirmed patients and more than deaths from sars-cov- infection in china, and , confirmed patients and deaths in the most affected province, hubei province. much research progress has been made in dissecting the evolution and origin of sars-cov- and characterizing its clinical features. [ ] [ ] [ ] [ ] [ ] while the outbreak is on-going, people raise grave concerns about the future trajectory of the outbreak, especially given that the working and schooling time has been already dramatically postponed after the chinese lunar new year holiday was over (scheduled on jan ). in particular, a precise estimation of the potential total number of infected cases and/or confirmed cases is highly demanding. earlier studies based on susceptible-exposed-infectious-recovered metapopulation and susceptible-infected-recovered-dead models revealed the number of potentially infected cases and the basic reproductive number of sars-cov- . , , these traditional epidemiological models apparently require much detailed data for analysis. , here we explored a simple data-driven, boltzmann functionbased approach for estimation only based on the daily cumulative number of confirmed cases of sars-cov- (note: the rational for boltzmann function-based regression analysis is presented in supporting information (si) file). we decided to collect data (initially from jan to feb , ) in several typical regions of china, including the center of the outbreak (i.e. wuhan city and hubei province), other four most affected provinces (i.e., guangdong, zhejiang, henan, hunan) and top- major cities in china (i.e., beijing, shanghai, guangzhou, shenzhen). during data analysis on feb , , the number of new confirmed cases on feb in hubei province and wuhan city suddenly increased by , and , , respectively, of which , and , are those confirmed by clinical features (note: all the number of confirmed cases released by feb were counted according to the result of viral nucleic acid detection rather than by referring to clinical features). we thus arbitrarily distributed these suddenly added cases to the reported cumulative number of confirmed cases from jan to feb for hubei province by a fixed factor (refer to table s ), assuming that they were linearly accumulative in those days. it is the same forth with the data for wuhan city. regression analyses indicate that all sets of data were well fitted with the boltzmann function (all r values being close to . ; figs. a, b, s , and table ). the potential total number of confirmed cases for mainland china, hubei province, wuhan city, and other provinces were estimated as , ± , , ± , , ± and , ± ; respectively; those for provinces guangdong, zhejiang, henan and hunan were ± , ± , ± , ± , ± and ± , respectively ( table ) ; those for beijing, shanghai, guangzhou and shenzhen were ± , ± , ± and ± , respectively. in addition, we estimated the key date, on which the number of daily new confirmed cases is lower than . % of the potential total number as defined by us subjectively (refer to table ). the above analyses were performed assuming that the released data on the confirmed cases are precise. however, there is a health commission, the state administration of traditional chinese medicine, the academy of chinese medical sciences, provinces and cities, as well as the army ( fig. ) . huoshenshan hospital is a specialized hospital established in the wuhan staff sanatorium. patients with confirmed coronavirus pneumonia have been admitted to our hospital. it has a total of beds, and includes an intensive care unit, an ordinary care unit, a laboratory, and radiology and other auxiliary departments. according to the national health commission of the people's republic of china, the related design scheme of the institute was completed on january , . construction of the hospital began on january th, and the hospital was completed and put into use on february nd. the chinese people's liberation army has transferred medical personnel to undertake the task of helping people infected with the virus. we firmly believe that chinese medical personnel and people throughout the country can work together to win this defensive battle with one heart and one mind. herpes simplex virus (hsv) pneumonia in the non-ventilated 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indebted to all colleagues who contributed to this substudy in paris and geneva. in particular, we would like to thank no public or private funds were used for the current study. eliseo albert holds a río hortega research contract from the carlos iii health institute (ref. cm / ). estela giménez holds a juan rodés research contract from the carlos iii health institute (ref. jr / ). we thank all the staff of the domestic and international organizations who fought against this outbreak, including those at the various health care facilities, lassa fever diagnostic laborato-ries, nigeria centre for disease control, world health organization, african field epidemiology network, public health england, ehealth africa, pro health international, university of maryland baltimore, us centers for disease control and prevention, alliance for international medical action, médecins sans frontières, and numerous other partners. we also express our sincerest condolences to the families and friends of those who died during the outbreak. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sector. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . this work was supported by the national natural science foundation of china ( ), and the guangdong provincial natural science foundation ( a ). we are grateful to the patients for providing their written informed consent to publish this report. our thanks go to nursing, laboratory and medical colleagues in hull university teaching hospitals nhs trust and the newcastle upon tyne hospitals nhs foundation trust who contributed directly and indirectly to patient care, and to many colleagues in public health england and across the hcid network who contributed their time and expertise to the management of these cases. cjad is supported by a clinical research career development fellowship from the wellcome trust ( /z/ /z ). we thank graduate students (boyan lv, zhongyan li, zhongyu chen, yu cheng, mengmeng bian, shuang zhang, zuqin zhang, and wei yao; all from prof. xinmiao fu's research group at fujian normal university) for data collection. this work is support by the national natural science foundation of china (no. and to xf). the reported cumulative number of confirmed cases may have uncertainty. assuming the relative uncertainty follows a single-sided normal distribution with a mean of . and a standard deviation of %, the potential total number and key dates were estimated at % ci. for detail, refer to the methods section and figs. c, d, s and s .b key date is determined when the number of daily new confirmed cases is less than . % of the potential total number. tendency to miss-report some positive cases such that the reported numbers represent a lower limit. one typical example indicating this uncertainty is the sudden increase of more than new confirmed cases in hubei province on feb after clinical features were officially accepted as a standard for infection confirmation.another uncertainty might result from insufficient kits for viral nucleic acid detection at the early stage of the outbreak. we thus examined the effects of such uncertainty using a monte carlo method (for detail, refer to the methods section in si file). for simplicity, we assumed that the relative uncertainty of the reported data follows a single-sided normal distribution with a mean of . and a standard deviation of %. under the above conditions, the potential total numbers of confirmed cases of sars-cov- for different regions were estimated ( figs. c, d, s and s ) and summarized in table , ), respectively, indicating that overall the outbreak may not be so bad as previously estimated. such uncertainty analysis also allowed us to estimate the key dates at % ci. as summarized in table , the key dates for mainland china, hubei province, wuhan city, and other provinces would fall in ( / , / ), ( / , / ), ( / , / ) and ( / , / ), respectively.finally, the ongoing sars-cov- outbreak has undoubtedly caused us the memories of the sars-cov outbreak in . we thus collected the data from the who officiate website for analysis, and found that the cumulative numbers of confirmed cases of sars-cov both in china and worldwide were fitted well with the boltzmann function, with r being . and . , respectively ( figs. e and f) .in summary, we found that all data sets, including both the on-going outbreak of sars-cov- in china and the sars-cov epidemic in china and worldwide, were well fitted to the boltzmann function ( fig. and s ). these results strongly suggest that the boltzmann function is suitable for analyzing the epidemics of coronaviruses like sars-cov and sars-cov- . one advantage of this model is that it only needs the cumulative number of confirmed cases, somehow as simple as the recently proposed model. in addition, the estimated potential total numbers of confirmed cases and key dates may provide valuable guidance for chinese central and local governments to deal with this emerging threat at current critical stage. none. supplementary material associated with this article can be found, in the online version, at doi: . /j.jinf. . . . we appreciate the work tang et al. have report emergence of a novel coronavirus in china. the -ncov broke out in wuhan, china at the end of , and has attracted worldwide attention. [ ] [ ] [ ] although the chinese government has taken active measures to control this epidemic, the virus is very infectious. according to the real-time data of the national health commission of the people's republic of china up until february , , within a short period of half a month, the number of confirmed cases and the number of deaths were , and , respectively. the epidemic is progressing rapidly. -ncov poses new public health challenges in china. in wuhan, china, the number of local medical staff is insufficient for the demand resulting from the explosive increase in the number of infected patients. therefore, many medical personnel are needed to devote themselves to the front line of combating the virus.medical personnel throughout the country are led under the unified leadership of the chinese government. although the epidemic in wuhan is serious, a large number of medical staff rushed to wuhan to supplement the shortage of manpower in wuhan hospitals. this is a battle without smoke, the heroes of which are our medical staff. according to the national health commission of the people's republic of china, as of january , , hubei province opened , isolated patient beds, and about , healthcare professionals from all kinds of medical institutions are working on the front lines and providing care for patients with fevers, and for suspected or confirmed patients. in this time of emergency, under the unified deployment of the chinese government, there are medical teams including medical personnel from the national key: cord- -j ybcv authors: beebe, james l. title: public health and clinical laboratories: partners in the age of emerging infections date: - - journal: clin microbiol newsl doi: . /j.clinmicnews. . . sha: doc_id: cord_uid: j ybcv clinical and public health laboratories have experienced unprecedented challenges in the form of demands to comply with revised regulations and economic pressures to be more efficient while preparing to respond to everything from pandemic influenza to bioterrorism. these forces have been an impetus for laboratorians to communicate, cooperate, and collaborate as never before and to seek the common ground where knowledge and resources can be shared to weather the profound economic and political forces at work today. the appearance of newly emerging and reemergent infections caused by agents of foodborne illness, anthrax, smallpox, plague, influenza, and other diseases has fostered cooperative network enterprises between clinical and public health laboratories, allowing the early detection of outbreaks of common and unusual pathogens and the measurement of the effectiveness of public health measures. the pace of change in the laboratory community continues to accelerate. both clinical and public health laboratories have experienced unprecedented challenges. demands for compliance with revised regulations have arrived at the same time as the need for laboratories to be prepared to respond to everything from pandemic influenza to bioterrorism. these forces have swept together clinical and public health laboratorians, as well as laboratory workers from other arenas. laboratorians are finding the need to communicate, cooperate, and collaborate as never before and are seeking the common ground in which to share knowledge and resources to weather the profound economic and political forces at work today. in , a health and human services-commissioned report by the lewin group ( ) identified the trends that were affecting public health and clinical laboratories. those forces are still at work. table is a summary of some of the economic forces, including the rise of managed care organizations and their attendant accumulation of bargaining power with reference laboratories. in the face of ever-rising health care costs, hospitals are enduring unrelenting pressure to reduce laboratory costs, resulting in the formation of consortium laboratories among hospital groups, referrals of specimens to private reference laboratories, closings of smaller hospital laboratories, and reductions in laboratory staff. table shows the forces at work for clinical laboratories, which are fighting battles on two fronts to maintain staff levels against further erosion. management is asking for workforce reductions, while fewer qualified applicants are available for open positions. with the closing of many medical technology schools over the past two decades, graduating medical technologists, clinical laboratory scientists, and technicians number less than half of projected workforce needs. at the same time, the federal health insurance portability and accountability act (hipaa) has placed new demands for secure patient information handling, adding another burden on laboratory staff ( , ) . table lists the forces at work with public health laboratories. while engaged in traditional public health activities, these laboratories are experiencing multiple new pressures, including hipaa and clia regulatory compliance issues, the need to be prepared for analytic response to bioterrorism acts, loss of state funding with a parallel need to bill medicaid for patient testing and provide testing on a fee-for-service basis. while a significant amount of funding support and technology transfer has accompanied the charge to state and local public health laboratories to develop capability for bioterrorism testing, state funding for traditional public health testing has withered ( ) . in this setting, new, emerging infections continue to arise. emerging infections have required public health laboratories to be able to test accurately for many new agents, either confirming clinical laboratory findings or testing specimens referred from clinical laboratories. the prospect of a continued emergence of newly recognized pathogens or reemergent agents is waxing strong. in spite of all these issues, or because of them, public health and clinical laboratories are working together to surmount the challenges and provide quality in both patient care and public health laboratory testing. several new initiatives have been launched to facilitate the collaboration of laboratorians, but while most public health laboratorians know what clinical laboratories do, the reverse is often not true. table illustrates the parallel, but different, roles each plays. clinical laboratories are focused on patient care, while public health laboratories are focused on the health of the entire population. clinical laboratory information is directed to physicians, and from them, ends at patient care. in contrast, public health laboratories gather information for public health experts and epidemiologists, who must determine the cause of illnesses and outbreaks affecting patients in many hospitals, detect new and unusual threats to the health of the community, and respond to these threats and prevent them. these roles are complementary, and as many laboratory professionals are discovering, mutually supportive. the institute of medicine report, the future of public health ( ), defined for the first time the functions of public health as (i) assessment, (ii) policy development, and (iii) assurance. these the need for cooperation and collaboration among laboratories has been long recognized by public health experts. in , a cdc strategy document ( ) outlined the need for the formation of networks to gather information to detect, report, and analyze information regarding infection. this document became the foundation for actions that led to the formation of networks that are cementing bonds between clinical and public health laboratories. clinical laboratories have traditionally referred isolates to public health laboratories for confirmation and serotyping, but beginning in , these isolates were subjected to a new powerful method to type the strains. public health laboratories began to use pulsedfield gel electrophoresis (pfge) to type isolates of escherichia coli o :h and other foodborne-illness pathogens, subdividing these isolates into closely related groups or clones, and allowing epidemiologists to efficiently investigate cases of infections and determine the cause. often, clusters of cases are seen immediately by public health laboratory scientists when a group of isolates with a unique pattern are observed. epidemiologists can investigate smaller numbers of cases and spend less time collecting the information that points to a particular food product. this has occurred many times since the initiation of the pulsenet system. outbreaks caused by salmonella spp., shigella spp., e. coli o , and camplylobacter and listeria spp. are detected, and the numbers of cases are limited when the incriminated food product is determined and recalled. clinical laboratories are being encouraged to refer such pathogens quickly, rather than letting a group of isolates accumulate for convenient transport to a state laboratory, where outbreaks of foodborne illness can be identified rapidly, resulting in limitations on the extent of outbreaks ( ) . pfge patterns uploaded by public health laboratories to the cdc pulsenet database are examined by epidemiologists looking for the appearance of clusters that cross state borders. numerous multi-state and national foodborne-illness outbreaks have been uncovered that could not have been detected by other means. pulsenet works because clinical laboratories are effective in culturing agents of foodborne illness and referring these isolates quickly to public health laboratories that perform pfge typing, conduct a statewide analysis, and then upload this information to the cdc database for nationwide analysis. this partnership has raised the level of detection of foodborne illness to unprecedented levels, virtually ensuring that no multistate outbreak of foodborne illness of any significant magnitude will go undetected. when three state laboratories determine a strain to be the same by pfge typing, the recovery of a single isolate by each of three clinical microbiologists in three different states might be enough to detect a nationwide food problem. the recovery and referral of isolates have done more than detect outbreaks of foodborne illnesses. by extremely accurate measurements of the number of infections in states, the cdc's emerging infections program (eip), a program for surveillance of invasive bacterial infections, has shown that vaccines, such as the pneumococcal vaccine, are highly effective and virtually eliminate illness in vaccinated groups ( ) . an eip program called foodnet is an alliance of state public health programs and clinical laboratories, which, year-to-year, has determined the overall rates of sporadic cases (not outbreaks) caused by a number of foodborne pathogens and the factors associated with infection. the isolation of agents such as salmonella, shigella, and listeria spp. and e. coli o , which are recovered by clinical laboratories and referred to state public health laboratories, is doubly important because it provides critical information in revealing outbreaks and allows measurement of the overall disease burden of sporadic cases. sporadic cases are those in which an outbreak has not occurred but some part of the food system has failed. over the past years, extremely accurate data have shown that the numbers of cases of illness due to some foodborne pathogens have declined ( , ) . these data provide hard evidence that food safety measures are actually protecting people from foodborne illness. initiatives in several states have spawned a new model for progressive collaboration between clinical and public health laboratories. with support from the cdc, states, and other agencies, cooperative state-based networks, such as the colorado laboratory forum, the minnesota laboratory system, the nebraska laboratory system, the washington state clinical laboratory initiative, the michigan laboratory system, and groups in other states, have been set up. table shows a broad array of activities in which these new networks are engaged, including improving communication, providing education and training, enhancing the quality of laboratory data, responding to emergencies, and sharing information. as an example, the colorado laboratory forum consists of laboratorians from clinical, public health, veterinary, agricultural, forensic, environmental, federal, military, food, and research agencies, with the following goals: to facilitate communications, improve analytic capabilities of all member laboratories, and facilitate education and training. the goal is to solidify these state groups into a national laboratory system ( ). clinical laboratorians can capture the first evidence of biologic-agent use by culturing the agent and conducting presumptive identification tests. during the anthrax spore attacks of , it was a clinical microbiologist who, shortly after taking training provided by public health laboratories, recognized and referred the isolate from the first case of anthrax ( ) . public health groups have provided training for clinical laboratorians to ensure that agents of anthrax, plague, and tularemia, rarely seen by any laboratory worker in the united states, are recognized and referred as soon as possible. the partnership is evident. clinical microbiologists are at the front lines, handling, culturing, and testing primary specimens and providing the information needed to make the primary diagnosis. public health microbiologists are in the best position to train clinical microbiologists about bioterrorism agents and then to rapidly confirm the identity of referred isolates. trained and equipped, public health laboratories are using leading-edge methods developed at the cdc, such as real-time pcr, luminex-type assays, and time-resolved fluorescence antigen immunoassays ( ) . these new methods have elevated identification accuracy to new heights while reducing the time needed for confirmation to a few hours rather than the many days conventional techniques typically require. clinical laboratory microbiologists, by serving in the role of sentinels, have responded to the call, rapidly referring suspicious isolates to their partner public health laboratories, which can then either confirm the identity of or rule out a possible agent of bioterrorism. clinical and public health laboratories each have an indispensable function, and neither can be successful without the other. many public health laboratory scientists have had to adopt a new leadership role for the state or city to which they are responsible, providing training; establishing safe and secure laboratory facilities for possessing, using, and maintaining select agents; channeling funding to clinical laboratories for bioterrorism preparedness and communications; and maintaining links between laboratories. the end result of these collaborative efforts is difficult to ascertain, but collectively, factors such as the reduction in the size and frequency of outbreaks and sporadic cases of infection, proof that food safety practices are effective, and validation of the efficacy of new vaccines can result in a healthier population, the goal of both medical care and public health. a healthier population means a reduction in the overall cost of health care related to infections. the alliance of clinical and public health laboratories promises to be a key component in slowing the rise of health insurance costs and managed care expenses. report for the office of the assistant secretary for planning and evaluation, office of health policy. public health laboratories and health system change managed care deeply affecting clinical microbiology committee on the study of the future of public health, division of health care services. . the future of public health core functions and capabilities of state public health laboratories response of the clinical microbiology laboratory to emerging (new) and reemerging infectious diseases addressing emerging infectious disease threats: a prevention strategy for the united states pulsenet: the molecular subtyping network for foodborne bacterial disease surveillance, united states epidemiology of invasive streptococcus pneumoniae infections in the united states, - : opportunities for prevention in the conjugate vaccine era dramatic decrease in the incidence of salmonella serotype enteritidis infections in foodnet sites: - preliminary foodnet data on the incidence of infection with pathogens transmitted commonly through foodselected sites, united states the us needs a national laboratory system bioterrorismrelated inhalational anthrax: the first cases reported in the united states the laboratory response network for bioterrorism key: cord- - u xe authors: hsu, chih-cheng; chen, ted; chang, mei; chang, yu-kang title: confidence in controlling a sars outbreak: experiences of public health nurses in managing home quarantine measures in taiwan date: - - journal: am j infect control doi: . /j.ajic. . . sha: doc_id: cord_uid: u xe background: taiwan experienced one of the most serious outbreaks of severe acute respiratory syndrome (sars) during the epidemic. public health nurses faced unprecedented challenges in implementing an extensive quarantine policy to prevent disease spread. their professional confidence, however, was shattered during the sars crisis. this paper assesses factors related to public health nurses' confidence in managing community sars control programs. methods: in may , we sent structured questionnaires to all health centers in taiwan and asked the public health nurses responsible for epidemic control to complete. a total of completed surveys were returned for a response rate of . %. descriptive methods and logistic regression were used to analyze the data. results: most public health nurses ( . %) expressed a general lack of confidence in handling the sars epidemic. confidence was significantly associated with perceived epidemic severity (or, . ; % ci: . - . ), daily epidemic updates (or, . ; % ci: . - . ), and number of cases in the community (or, . ; % ci: . - . ). conclusion: nurses' individual risk perception and prompt update of epidemic information significantly affect levels of professional confidence, a key factor influencing quarantine implementation success. strategies to promote productive interagency collaboration and advocate participatory policy making involving health workers at all levels are needed to control effectively infectious disease outbreaks. the global spread of severe acute respiratory syndrome (sars) in was a prelude to other emerging infectious diseases in the st century. recent outbreaks of h n avian influenza in asia continue to remind the world of the threat of periodic and unpredictable recurrences of pandemic contagion. since the beginning of the sars outbreak, many scientists have worked to characterize the coronavirus, , trace epidemic patterns, and synthesize potential vaccines to prevent further outbreaks. , however, the global experience of managing sars has revealed that reducing contact between people by implementing quarantine measures is as important as discovering effective remedies. , taiwan reported probable sars cases and sars-related deaths during the outbreak in , making it one of the most serious sars epidemic areas in the world , figure shows the chronology of the sars epidemic in taiwan. facing this unprecedented outbreak, the taiwan government began implementation of compulsory home quarantine on march to stop community transmission. individuals who were suspected to have been infected with sars were quarantined at home (or in special facilities) for to days. in those months of the epidemic period, , individuals were quarantined in taiwan. this includes , people who had close contact with sars patients and , travelers who came to taiwan from world health organization (who)-designated sars-affected areas. , public health administration in taiwan is organized at levels: national, city/county, and township. generally speaking, national health policies are often formulated in the national department of health (doh) with participation of city/county health bureau officials. the health centers (or health stations, as they are called) are the local agencies situated in the townships. the major responsibility of health centers is to implement public health protocols developed at the national and city/ county levels. the directors of health centers are usually licensed physicians. public health nurses are usually the supporting staff who carry out program assignments. the public health operation in taiwan is managed under this clear chain of command. under this system, taiwan eradicated malaria infection in the s, succeeded in having % of all married women aged to years practice contraception in the s, and dropped % of hepatitis b carriers in the s. public health nurses working at the local health centers played a key role in achieving public health success in taiwan. however, the public health nurses were unprepared in at the time of the sars crisis. sars hit taiwan in march . in response to the outbreak, the doh created an emergency operation office and appointed an anti-sars task force commander to direct a comprehensive national sars control program. home quarantine was ordered for all suspected sars cases. health centers at all localities were asked to implement the home quarantine policy. local public health nurses were not invited to participate in the national sars control policy making but were requested to carry out the mission. during the quarantine period, public health nurses were requested to undertake several public health measures, which included conducting initial registration, maintaining daily temperature records, disposing of personal trash, and providing social support and advice on medical care to those with a fever or sars-related symptoms. success in quarantine management was considered a crucial factor in the successful control of sars. however, it was soon evident that public health nurses' lack of experience in managing community quarantine and their fear of being infected with sars presented a major challenge. this study was designed to understand better the challenges and threats facing public health nurses responsible for implementing sars quarantine procedures. the results will be valuable for developing better strategies for controlling the rapid spread of infectious diseases such as sars. an attitudinal questionnaire was developed by researchers in may at the peak of the taiwan sars epidemic. questionnaire items were designed on the basis of the working experience of a panel of public health nurses. the questionnaire went through a content validation process. six experts from public health or community nursing fields served as the expert panel in checking the validity of questionnaire items. the drafted questionnaire was piloted for understandability among public health nurses in northern taiwan. moreover, within week after the questionnaires were returned, the researchers randomly selected and phoned respondents (approximately % of the total) to check the reliability of their written answers. the test/retest reliability for this questionnaire was high (pearson correlation coefficients for continuous variables: . - . ; spearman rank correlation coefficients for categorical variables: . - . ). one section of the questionnaire was designed to collect baseline information, including ( ) demographics, ( ) number of quarantined cases managed and responsibilities within the previous week (itemizing quarantine-related extra workload), and ( ) the date the nurses predicted sars epidemic would end. another section (using categorical scales) asked about sars-related operations that included the frequency of ( ) epidemic information updated in the health center, ( ) sars-related training courses received, and ( ) assistance of community volunteers on quarantine measures. the third section contained questions (using -point likert scale: the worst to the best) about the effectiveness of the nurse's institution in managing the sars epidemic, including the nurse's assessment of ( ) the institutional functioning on community home quarantine, ( ) the quality of training received for controlling infectious disease outbreaks, and ( ) the adequacy of support (for both manpower and financing) received from superior health agencies force commander said the epidemic situation was stable and advised people to return to their routine. (e) who removed taiwan from its list of areas to which travelers were advised to avoid for all but essential travel. (doh or city/county health bureaus). in the fourth section of the questionnaire (also using -point likert scale), the nurses were asked to assess the severity of the epidemic, the public's awareness of the epidemic situation, the public's fear of sars, and the public's compliance with official quarantine measures. finally, the nurses were asked to list major difficulties they encountered in managing the sars epidemic. the main island of taiwan has a total of health centers. on may , , questionnaire was mailed to each of the health centers to be completed by the head nurse or the nurse in charge of sars epidemic control. a reminder letter was sent week later to nonresponding centers. a total of completed surveys were returned for a response rate of . %. logistic regression was used to identify variables associated with the nurses' lack of confidence in sars control. nurses who estimated that the sars epidemic would not be declared ''ended'' by the who until mid-september or later (the who declared taiwan sars free on july ) were categorized as ''less confident.'' logistic regression also identified variables associated with public compliance of official anti-sars measures. variables in univariate models that exerted a significant effect were subjected to multivariate logistics to assess significance level. statistical analyses were performed using sas . (sas institute inc., cary, nc). all reported p values were -sided; p , . was considered statistically significant. table , approximately half ( %) of the respondents were to years of age, one third ( %) to years, and % older than years. most respondents ( %) had at least years of experience working in a health center. approximately % of respondents believed the sars outbreak would be controlled by mid-july; the remainder of the respondents believed control would not occur until mid-september ( %), mid-december, or later ( %). many public health nurses encountered difficulties while performing sars-related duties. they expressed dissatisfaction with the shortage of protective equipment such as n masks and gloves ( %), public resistance to following protection measures ( %), poor interagency communication ( %), and lack of standard operating procedures ( %). as shown in table , nurses' perceptions of epidemic severity were negatively associated with confidence that the epidemic could be controlled (or, . ; % ci: . - . ). nurses in health centers receiving fewer epidemic updates were more likely to doubt the effectiveness of epidemic control measures (or, . ; % ci: . - . ). nurses working in areas with relatively fewer probable sars cases were less confident in control efforts (or, . ; % ci: . - . ). several factors contributed to the public's lack of cooperation with sars-related home quarantine measures (table ). according to the nurses, people were less likely to cooperate with quarantine measures when ( ) they were less knowledgeable about sars (or, . ; % ci: . - . ), ( ) they expressed less fear of sars (or, . ; % ci: . - . ), ( ) the health centers were not functioning well (or, . ; % ci: . - . ), and ( ) the health centers received inadequate manpower or financial support from higher health authorities (or, . ; % ci: . - . ). this study is the only study reporting on the assessment of frontline nurses' reactions to home quarantines implemented by most health centers in taiwan during the sars outbreak. survey respondents were mainly head nurses with more than years of health center experience and were very familiar with their organizations, clients, communities, and issues surrounding quarantine operations. furthermore, because they were required to interact directly with quarantined persons, they had the best opportunity to understand the community's response to the sars outbreak. also, because the survey was conducted just after the sars epidemic had peaked, the related experiences were fresh in their minds, and recall bias would have been minimal. therefore, this report can be a valuable reference for the control and management of sars-like contagious disease outbreaks. the who removed taiwan from its list of sarsinfected areas on july , ; however, even at the beginning of june, many taiwanese, including public health officials and lay people, remained pessimistic about the success of sars control measures. as shown in table , most public health nurses ( . %) believed that the outbreak would not end until mid-september or even later. there was at least a -month difference between frontline nurses' estimates and the actual timing of the epidemic's end, indicating a low confidence level on the part of the nurses. this is serious because the pessimistic attitudes of nurses could affect the morale of quarantined subjects, people in the community, and, eventually, the success of the sars control program. why did public health nurses lack confidence in implementing the anti-sars program? as shown in table , individual risk perception, working environment of the health centers, and epidemic severity in the community were contributing factors. during the sars epidemic, the taiwan government made efforts, via media announcements, to assure the public that the situation was under control. from may , all major television channels broadcast daily the ''sars front-line'' program on the evening news. the premier and the commander of the anti-sars task force also repeatedly delivered public announcements that said the outbreak would soon be over. [ ] [ ] [ ] however, these optimistic public announcements were not always trusted by frontline nurses. the daily epidemic reports received by the nurses always seemed to be outdated. as the severity of the epidemic lessened day by day, the outdated data that showed a more severe phase of epidemic were counterproductive to boosting nurses' trust in the government's optimistic announcements. it appears that providing public health nurses with rapidly updated information is of utmost importance. results also show that risk communication at the time of infectious disease outbreak should be based on timely, rapidly updated, and evidence-based data to supplement routine government announcements. we determined whether nurse confidence in epidemic control measures was a function of extra hours and activities required for managing the epidemic. results indicated that lower confidence levels were associated with fewer cases in the community (table ) . without an immediate threat, health centers in counties/cities with few sars cases might not have fully mobilized their community resources to prepare the public or their nurses for sars prevention and control measures. because the national media broadcasted sensationally on the severity of sars epidemics, public health nurses without sufficient preparation and support might have been more vulnerable to rumors and speculation about negative aspects of the outbreak such as mortality rate, resulting in a loss of confidence in organized efforts to control the sars epidemic. another factor contributing to nurses' low confidence may be related to their lack of opportunity to participate in the formation of national policy, which they are asked to implement at the local level. according to the aforementioned traditional chain of command in the taiwanese public health bureaucracy, when the sars policy was developed, standard procedures for field operations were decided by the national office. without having policy fine-tuned with input from frontline nurses, this top-down policy could not promptly respond to local needs that changed rapidly according to the disastrous nature of sars contingencies. it is obvious that the long-established champion of the taiwanese public health system needs an effective feedback mechanism to renovate its response to newly emerging infectious outbreaks. a platform that encourages participatory decision making involving health professionals at all levels should be critically emphasized in developing a national policy to control sars-like outbreaks of pandemic contagion. frontline nurses reported that one of the most frustrating experiences during the sars epidemic was the reluctance of people to follow quarantine guidelines. this was independent of local epidemic severity but significantly related to people's cognitive preparedness and the efficiency of interagency collaborations (table ) . quarantine restricts the movement of people who can potentially expose others to a disease. , how to implement effectively a community-wide quarantine therefore presents a major challenge to health agencies. table shows that people who were less knowledgeable about the sars outbreak and those who expressed little fear of infection were less compliant in following anti-sars measures. in the future, more efforts should be placed on educating people to increase their health knowledge and beliefs, especially about risk susceptibility and severity, and belief in the benefits of taking health actions. , moreover, effective community health education programs that emphasize community-based participatory research and education should be considered. , from a national perspective, a comprehensive sars control strategy should also be developed that would streamline communication and resource sharing among health agencies at all levels. in summary, public health nurses' confidence in the control of a sars outbreak and people's compliance with quarantine measures are major factors that can affect the success of a sars-control program. other important determinants to a successful program include effective risk communication, participatory policy making that involves health workers at all levels, and intergovernmental collaboration at national and local levels. factors critical to sars management are similar to those for crisis management of avian influenza outbreaks and of the results of terrorist acts. [ ] [ ] [ ] [ ] lessons learned in this study can serve as useful guidelines to prevent and manage emerging infectious disease outbreaks. sars: unprecedented global response to a newly emerging disease avian influenza and pandemics sars virus: the beginning of the unraveling of a new coronavirus sars: beginning to understand a new virus a double epidemic model for the sars propagation current concepts in sars treatment treatment of sars with human interferons evaluation of control measures implemented in the severe acute respiratory syndrome outbreak in beijing preventive strategies to keep saudi arabia sars-free information below was mainly re-classified according to the current sars definition and test results in laboratory from who. center for disease control taiwan basars%ac%db%c %f %b %ea%b t/%a x%c wsars%ac% control measures for severe acute respiratory syndrome (sars) in taiwan use of quarantine to prevent transmission of severe acute respiratory syndrome-taiwan health care system in a transitional society: a taiwan experience. a conference speech delivered at the international research foundation for development sars: a perspective from a school of nursing in hong kong china: sars transmission interrupted in last outbreak area who estimated that the taiwan epidemic situation might be under control in six to seven weeks the premier said that the outbreak would be over by the end of the chief commander of anti-sars project in taiwan said it did not need seven weeks to control the outbreak efficiency of quarantine during an epidemic of severe acute respiratory syndrome community based participatory research: a promising approach for increasing epidemiology's relevance in the st century community-based participatory research: an approach to intervention research with a native american community who views on perspectives in health informatics introduction to community empowerment, participatory education, and health the public and effective risk communication communicating risk: wireless and hardwired public reliance on risk communication channels in the wake of a cryptosporidium outbreak bioterrorism risk communication policy key: cord- - t kubf authors: miralles, oriol; sanchez-rodriguez, dolores; marco, esther; annweiler, cédric; baztan, ainhoa; betancor, Évora; cambra, alicia; cesari, matteo; fontecha, benito j.; gąsowski, jerzy; gillain, sophie; hope, suzy; phillips, katie; piotrowicz, karolina; piro, niccolò; sacco, guillaume; saporiti, edoardo; surquin, murielle; vall-llosera, estel title: unmet needs, health policies, and actions during the covid- pandemic: a report from six european countries date: - - journal: eur geriatr med doi: . /s - - -x sha: doc_id: cord_uid: t kubf purpose: the united nations (un) has published a policy brief on the impact of the coronavirus disease (covid- ) that identifies policies and responses to protect older adults. our objective was to summarize actions, health policies and clinical guidelines adopted by six european countries (belgium, france, italy, poland, spain and united kingdom) during the pandemic, and to assess the impact of national policies on reducing adverse effects of the covid- pandemic in older populations. methods: reports by geriatricians on the measures and actions undertaken by governmental institutions in each country between march and july , as well as the role of primary care during the pandemic, covered three areas: (a) general health strategies related to the pandemic; (b) impact of covid- on health inequity; and (c) initiatives and challenges for the covid- pandemic and beyond. results: in the six countries, covid- mortality in nursing homes ranged from to %. although all countries endorsed the world health organization general recommendations, the reports identified the lack of harmonized european guidelines and policies for nursing homes, with competencies transferred to national (or regional) governments. all countries restricted visits in nursing homes, but no specific action plans were provided. the role of primary care was limited by the centralization of the crisis in hospital settings. conclusions: the older population has been greatly affected by covid- and by the policies initiated to control its spread. the right to health and dignity are transgenerational; chronological age should not be the sole criterion in policy decisions. public health measures recommended by the world health organization (who), such as contact tracing, social distancing and mass testing, there had been , , confirmed cases with a total of , as of st july . over two million of these cases and nearly , of the deaths were in europe [ ] . european countries have the largest percentage of the older population in the world. increased age has been associated with worse outcomes in covid- : older adults are more susceptible to the infection and have a significantly higher risk of severe disease and serious complications. moreover, % of deaths from covid- have occurred in those older than , and % in people aged or older [ ] . the main reasons suggested for the more severe effects of covid- on the older population include the physiological changes associated with ageing, decreased age-related immune function and the presence of frailty (covid- frailty spiraling syndrome) [ ] . other geriatric syndromes such as cognitive decline or a reduced performance in activities of daily life play an important role in older patients' ability to cope with severe stressors such as critical illness, and might have influenced the higher rates of clinical adverse outcomes during the covid- crisis. the characteristics of the healthcare systems and the sociodemographic needs of the different european countries vary widely, and the measures recommended by the who (summarized in fig. ) have been applied differently across different countries and regions. aware of the risks and potential inequalities in access to healthcare, the united nations (un) launched the un policy brief: 'the impact of covid- in older persons', a report about health policies to ensure meeting the needs of older populations, especially the most vulnerable [ ] . the european union geriatric medicine society (eugms) joined the un effort and gathered the covid- task force, which promotes collaborative initiatives from the geriatrics and the national societies across europe [ ] . our working group has followed this call to action to ponder the failures and successes of our responses to covid- pandemic. our initiative seeks to identify points for further improvement to ensure the highest quality of care for older adults across european countries with the perspective of a second wave or in case covid- is here for the long haul [ ] . our objective in the present analysis was to compile a brief summary of the actions, health policies and clinical guidelines adopted by six european countries (belgium, france, italy, poland, spain and united kingdom) between march and july . secondly, we discussed their impact on the older population following the four key priorities outlined in the un policy brief: . right to health and participation in the decision-making process. . social inclusion and solidarity under conditions of physical distancing. . necessity to provide adequate and correctly funded care and support services for older adults. . expand participation by older adults, share good practice and harness knowledge and data. this is a narrative review and authors' opinion on the impact of the covid- pandemic on the older population in belgium, france, italy, poland, spain and united kingdom between march and july . a research group from barcelona formulated the aim of developing a european working group representative of specialists in geriatric medicine. these specialists were asked to provide a report on the covid- crisis in their respective countries, to include three areas: ( ) response and difficulties related to the pandemic; ( ) health inequity and the impact of covid- ; and ( ) initiatives and challenges for the covid- pandemic and beyond. the information collected from the six national reports was pulled together and discussed following the key priorities for action outlined in the un policy brief: ( ) right to health and the participation in the decision-making process; ( ) social inclusion and solidarity under conditions of physical distancing; ( ) necessity of adequate, correctly funded care and support services for older adults; and ( ) need to expand participation by older adults, share good practice and harness knowledge and data [ ] . the literature search was conducted in medline (pub-med) and the webpages of government health departments, international health organizations, consensus reports and general position statements from scientific societies. between march and july , high numbers of deaths from covid- were recorded in four of the six participant countries (no data available for italy and poland), as shown in fig. . reports from geriatricians detailed responses and difficulties related to the pandemic and the impact of the disease on health inequity in older adults in their respective countries. initiatives and challenges to consider in preparation for a potential second wave of covid- are discussed below. the measures implemented against covid- in each country are summarized in fig. , which offers a concise comparison of the actions taken. belgium general health strategies related to the pandemic: the first cases in belgium were detected on nd march [ ] , ten days before the who declared a pandemic on th march . the website dedicated to covid- launched by the national institute of epidemiology and infectious diseases (sciensano) in the first week of march became an efficient communication tool during the crisis. on th march, belgium endorsed the general who recommendations [ ] . the strategy of the belgian healthcare authorities was focused to prevent overload of hospital capacity, particularly in intensive care and emergency departments. in the frenchspeaking region, the "plan d'urgence hospitalier" was launched on th march and focused on ensuring distribution of hospital equipment, including personal protective equipment (ppe), and human resources (e.g., by reduction/ impact of covid- on health inequity: on th may, belgium had reported people with confirmed sars-cov- infection in long-term care facilities (ltcf). from a total of covid- related deaths, ( %) were in ltcf, as shown in fig. [ ] . the nursing homes population was the most severely affected, probably due to the baseline health status of residents (higher comorbidity and frailty) and scarcity of resources. general governmental recommendations for the control of sars-cov- spread in nursing homes had been given, but not all of them could be implemented. the response of individual nursing homes depended on the local resources in terms of protection, isolation and medical care, which were shown to be insufficient when the demands exploded exponentially. new supplies perhaps became available too late: ppe distribution started on th march and systematic reverse transcription polymerase chain reaction (rt-pcr) testing for residents and workers on th april. the nursing homes registered each new case of covid- as "suspected", "confirmed after rt-pcr test" or "deceased" during part of the crisis. this registration procedure made it difficult to accurately quantify and differentiate the number of covid- related deaths from deaths related to worsening of previous chronic conditions or other acute processes, contributing to a general underestimation of the disease burden and mortality. decision-making regarding whether to transfer patients from the community or nursing home setting to a hospital was not based on age, but on functional capacity, health status and previous wishes expressed by the patients or their representatives. guidance to general practitioners regarding levels of therapeutic intensity and transfer decision-making came from scientific societies (e.g. the belgian society of geriatrics and gerontology [bsgg] and the société scientifique de médecine générale [ssmg]). the ssmg developed an algorithm based on rockwood's clinical frailty scale and semiology ("atypical" presentation of illness) of covid- . general health strategies related to the pandemic: the first three official covid- cases in france were listed on th january [ ] . the organization of the response of the health system in exceptional health situations (organisation de la réponse du système de santé en situations sanitaires exceptionnelles) launched a plan for epidemic and biologic risks (risques Épidémiques et biologiques) [ ] . stage one of this plan, called orsan-reb, was launched on rd february to limit the introduction of the sars-cov- into france. six days later, stage two was started to contain the epidemic by screening suspect cases and treating possible and confirmed cases in "covid- -ready" hospitals (individual focus). stage three, also known as the epidemic stage, was launched on th march [ ] and the french population was finally confined two days later [ ] , after cases and deaths. at this stage, given the active circulation of sars-cov- , the strategy shifted to a collective approach based on three main axes: ( ) to protect vulnerable populations, ( ) to treat mild patients in ambulatory care [ ] , and ( ) to treat serious cases in hospital [ ] . nevertheless, the protection of vulnerable populations had begun in stage two and all visits to nursing home residents were prohibited from th march. during this period and the following three weeks, even if the mortality rate increased in nursing homes, the first deaths in nursing homes were not communicated until st april. on th may, france had reported , people with confirmed sars-cov- infection in ltcf. of the , total covid- related deaths, , ( %) were in ltcf [ ] (fig. ) . impact of covid- on health inequity: at the beginning of the epidemic stage, the anticipation of a persistent lack of beds in intensive care units (icus) led to a reflection on the prioritization of care according to age. thus, on th march the ile-de france regional health agency relayed recommendations about the decision to admit to icu published by the french society of anesthesiology and resuscitation, in which age was clearly a criterion of decision (although without a specified cut-off age) [ ] . fortunately, these considerations were reported in mainstream media, which led to strong reactions from the population and to one of the first statements of the french national academy of medicine against ageism [ ] . with the intervention of the president of the french society of geriatrics and gerontology, hammering on the importance of self-determination in older adults, this criterion was finally abandoned on rd april. general health strategies related to the pandemic: the first confirmed case of sars-cov- infection in italy was identified on th february in the town of codogno (lombardy region) [ ] . this case was soon found not to be isolated, and the diffusion of the sars-cov- in the area was more rapid than expected. in the following days, social distancing measures were applied, culminating in a regional, and subsequent national, lockdown [ ] . the magnitude of events together with a general unpreparedness of the healthcare system made the covid- pandemic particularly burdensome in italy. in particular, several geriatric settings (e.g., nursing homes) found themselves completely abandoned, with major difficulties in managing their frail older patients [ ] . at the same time, hospitals (especially the emergency departments) were overwhelmed by patients with respiratory conditions, requiring clinicians to take tough decisions in an emergency characterized by lack of resources (e.g., ventilators) [ ] . impact of covid- on health inequity: in this scenario, many critical decisions were taken without supporting evidence (given the novelty of this coronavirus), support from ad hoc specialists, or adequate time to formulate a sufficiently informed plan. in other words, many of the choices made at the time might be at risk of being considered unethical [ ] . for example, the italian society of anesthesia, analgesia, and intensive care (siaarti) published the "clinical ethics recommendations for the allocation of intensive care treatments in exceptional, resource-limited circumstances", in which there is explicit mention about the role of age in the decision-making process: "an age limit for admission to the icu may ultimately need to be set. the underlying principle would be to save limited resources which may become extremely scarce for those who have a much greater probability of survival and life expectancy, in order to maximize the benefits for the largest number of people"; and "together with age, the comorbidities and functional status of any critically ill patient presenting in these exceptional circumstances should carefully be evaluated. a longer and, hence, more 'resource-consuming' clinical course may be anticipated in frail older patients with severe comorbidities, as compared to a relatively shorter and potentially more benign course in healthy young subjects" [ ] . although this document suggests consideration of comorbidities and functional status of the patients when taking decisions about covid- management, age is the first criterion mentioned, the easiest/quickest factor to be obtained in an emergency situation, and the logical parameter for resource allocation in an ageistic society such as the one we live in. the adoption of age as a cornerstone criterion for clinical decisions during the pandemic is also implicitly present in those directives that tried to limit access to hospital care for nursing home residents. moreover, the discharge of hospital patients-possibly with covid- to nursing homes (where the frailest and most vulnerable individuals live) was maintained, justified by the need for decompression of emergency departments. again, the traditional stigma affecting nursing homes determined the way in which the system reacted to the pandemic [ ] . general health strategies related to the pandemic: in poland, the sars-cov- outbreak started on th march with the so-called "patient zero", a -year-old man who travelled by bus from germany to poland. as of th june, there were , confirmed cases of covid- in poland. unfortunately, as of june , poland lacks regularly updated, publicly available information on the age structure of diagnosed, recovered and deceased persons with covid- , including separate reports for those aged and older. with regard to national guidelines, "call to action" documents for healthcare workers, patients and their families were launched by the college of family physicians in poland together with the polish college of geriatricians ( th march) [ ] and the polish society of gerontology ( th march) [ ] . on th april, the polish psychiatric association published a comprehensive set of recommendations for patients, caregivers and physicians concerning the appropriate approaches in patients with dementia during the covid- epidemic [ ] . in mid-march , the national health care system adapted to the changing requirements to sustain medical care. as a result, at the beginning, single-purpose infectious disease hospitals were established across the country for covid- patients, supplemented by infectious disease wards. none of these has been dedicated to the care of older patients exclusively. impact of covid- on health inequity: as of june , chronic comorbidities and patients' treatments are managed by way of tele-counselling whenever possible; no additional support or modality to facilitate healthcare services contact has been offered for older patients. no specific model of care has been proposed for the most vulnerable older adults (e.g., patients with dementia, frail or disabled). however, a telephone help-line for older persons has been established, dedicated to tackling the anticipated problems of depression and other mood disorders. national and local-level health care authorities have been using television and radio broadcast networks, social media and press for information campaigns covering sars-cov- prevention and risks. the first educational campaign concerning sars-cov- in poland had been introduced before the first case was confirmed, and was followed by more detailed and specific advice. no specific recommendations to older persons in general, beyond the who recommendations, were issued ( fig. ) . apart from this advisory position, no particular senior-targeted action was taken at the community level (including social support, meals-on-wheels, extra financial support for those affected by sars-cov- , etc.). day-to-day support is often provided by formal or informal volunteers, mobilized and coordinated by means of social networking. general health strategies related to the pandemic: spain is third in europe for the number of covid- cases, as of th june . despite the news coming from italy, no prevention policies were implemented in spain until th march. the impact of the covid- pandemic was greater than in neighboring countries such as portugal, which closed public facilities at the same time, but with the substantial difference that portugal had recorded cases of and no deaths at the date of closure of international borders ( th march), while spain had already recorded cases and deaths [ ] . although the outbreak began in early march, the first cases of covid- were confirmed in the canary and balearic islands in mid-february and mainly involved tourists from germany and italy [ ] . the spread of the virus and the impact in number of cases was uneven throughout spain, with madrid and barcelona being the most affected areas [ ] , where health resources soon collapsed. redistribution of hospital resources and relocation of health professionals was needed. the capacity of the icus could not keep up with the increasing demand, and they were expanded to double or triple capacity. the number of icu beds for , habitants in spain was . before covid- , in contrast to germany's . icu beds per , population [ ] . in the city of madrid, the pavilions of the city fair were converted into a field hospital to accommodate patients. other infrastructures, such as hotels and municipal gyms, were converted into hospitals for the control of post-acute covid- patients [ ] . impact of covid- on health inequity: as scientific societies and ethics committees developed recommendations to optimize the available resources, age was used as the primary variable in decision making in many of these recommendations, such as the protocols from the spanish society of intensive care medicine [ ] . the spanish ministry of health published action protocols for hospitals without specifically addressing the management of the older population. one of the most notable emergencies during the covid- pandemic was that of nursing homes [ ] . the large number of people living together and sharing common areas facilitated the spread of sars-cov- ; the patient profile, with high comorbidity, dependence and care needs, made them more vulnerable to the virus. finally, the lack of resources in nursing homes, such as lack of access to intravenous treatment, oxygen therapy, nurses or doctors, or facilities to treat acute patients, made the situation unsustainable [ ] . on th may, no exact numbers were available for cases of sars-cov- infection in ltcf in spain; nevertheless, of the , total deaths related to covid- , , were in ltcf, which represent % of the covid- related deaths in the country (fig. ) [ ] . in this context, the spanish ministry of health published hygiene recommendations and isolation measures for nursing homes. however, these did not specify clinical management or referral criteria [ ] . in catalonia, the department of health developed an action protocol in nursing homes stating: "it is not necessary to refer probable or confirmed cases to the hospital in a situation of advanced chronic disease, as a limitation of the therapeutic effort has been decided" [ ] . nonetheless, no ppe or medical supplies for the management of new covid- cases were provided to nursing home facilities, most of which are private and understaffed [ ] . it is true that referrals should be reduced as much as possible, but an advanced chronic disease cannot be a criterion for exclusion without previous assessment of functional status and life prognosis. as the health crisis progressed, primary care was instructed to coordinate with nursing homes, but given the results this approach was insufficient [ ] . general health strategies related to the pandemic: at the national level, all those deemed "clinically extremely vulnerable" were sent a letter explaining the need to "shield" for weeks [ ] [ ] [ ] . otherwise, social distancing was advised, with people at "moderate risk" or "clinically vulnerable" to take particular precautions, which included all people older than years, or with diabetes, asthma and other chronic conditions. confusion between clinically "vulnerable" and "extremely vulnerable" was perpetuated in public statements, leading to accusations at the government of being ageist [ ] . the british geriatrics society (bgs) has curated a helpful "coronavirus and older people" webpage with the most pertinent of many new and updated clinical guidelines [ ] . this includes some of the national institute for health and care excellence (nice) rapid covid- guidelines [ ] , as well as several specific good practice guides and fact sheets written by the bgs, such as "managing the covid- pandemic in care homes". in line with the uk's general approach, age has not been a specific point in covid- guidelines. the clinical frailty scale was introduced in "covid- rapid guideline: critical care in adults" (ng ) as a decision aid regarding whether patients would benefit from intensive care treatment. one of its stated purposes was to "enable services to make the best use of national health system (nhs) resources", albeit caveated with the need to exercise judgement and a reminder that compliance was not mandatory. there may be some positive legacies from new guidelines, such as improved appreciation of the frailty concept amongst non-geriatricians, and community palliative care provision. at the point of writing, th june , the uk has had , confirmed cases of covid- , and , covid- "associated" deaths [ ] . the total excess mortality, however, is currently estimated at , people, % over usual rates for this time of year and one of the world's highest [ ] . between may - , scotland reported , people with confirmed sars-cov- infection in ltcf (no data available for england and wales). in scotland, of the total , deaths related to sars-cov- , , ( %) were in ltcf (fig. ) . in england and wales, of the total , deaths related to covid- , ( %) were in ltcf (fig. ) [ ] . impact of covid- on health inequity: primary care was "reminded" to proactively have discussions with patients regarding their treatment escalation wishes. robust responses from the care quality commission, charity sector, and necessary clarifications and retractions followed. in april, nhs england recommended that primary care can "move immediately to total digital triage followed by remote management wherever possible and appropriate…" [ ] . non-digital users were able to access telephone support, but the push to online services has created a perceived barrier for some older people. arguably the most widespread implication for this population, however, was the early political emphasis on prioritizing hospitals, without sufficient safeguards for those residing/working in care home and social care sectors. the decision in march to empty nhs hospitals was alongside department of health and social care guidelines stating: "negative tests are not required prior to transfers/admissions into the care home" [ ] , despite unreliable ppe deliveries to care homes even by early may. discharging people from hospitals to care homes without sars-cov- testing had a devastating impact. by th may, % of care homes in england and % in scotland had a suspected/confirmed outbreak of covid- [ ] . figures for those receiving domiciliary care are more difficult to get, but in england between th april and th may, there were deaths, more than the -year average for the same time period [ ] . hospitals and care homes followed national guidance to restrict visiting, and, therefore, many died alone or with only staff members present, and social distancing has also had an impact on the bereavement process. support from institutions and health care providers should aim to address the specific needs of older patients. social adjustments have been made. in the uk, for example, early headlines highlighted difficulties with older adults getting food items, resulting in some supermarkets introducing special shopping hours only for them, and those with "shielding" letters could get priority online food deliveries. a need for digital connectivity and bank cards, or family/social support, was often needed to help access resources online. in many countries, the improved social and digital connectivity has been a positive outcome for some. otherwise mental health, and physical, cognitive and social deconditioning are major concerns, as well as delays to elective surgery and resultant deterioration in health. another shared concern was the lack of attention to providing adequate materials, medications and human resources to nursing homes. right to health is universal; this right cannot be subject to age. a related issue was the lack of guidelines for the management and hospital transfer of older patients with covid- , along with the subsequent isolation, infection control for residents, staff and visitors, and institutional and individual hygiene measures, as well as consistent reporting protocols. only reports from poland and uk mentioned the development of policies, national guidelines and protocols. development and systematic updating of harmonized european guidelines would provide a shared baseline of good practice, a benefit for all european countries that could save lives, time and confusion. media attention during the covid- pandemic has been mainly focused on the hospital centers. however, primary care and community pharmacy have played crucial, less publicized roles. the who recommendations on the role of primary care during the covid- pandemic (fig. ) highlight the importance of rapid diagnosis (given the risk of sars-cov- transmission between contacts), health education for the population to prevent infection, and the maintenance of essential health services in the general population [ ] . however, in many countries, especially those hardest hit by the pandemic, primary care has played more of a "buffer" role to desaturate hospital emergency departments, address collective anxiety and avoid if possible the admission of patients with chronic decompensated diseases [ ] . relocation of health professionals from primary care to hospitals limited the power of action against sars-cov- by primary care centers and overlooks the importance of primary care in guaranteeing continuity of care. new models have been developed to cope with the absence of physical consultations. web-based telemedicine (e.g., webpages, apps, etc.) and telephone calls have been given priority, whilst home medical visits have been reserved when physical examinations are required [ ] . these strategies have served to follow sars-cov- -positive patients in self-isolation but failed to fulfill one of the main objectives of primary care, e.g. to look after older people with chronic pathologies. some older people may thus have suffered from a reduction in control of chronic diseases, as well as struggling with fear and anxiety during the pandemic. chronic disease management has also moved almost entirely to remote consultations. on the other hand, several interesting initiatives have been taken across europe because of the covid- pandemic, such as an increased move to digital triage and liberalization of home oxygen therapy prescriptions (allowing earlier hospital discharges, or in some cases avoidance of hospital admission). attention has been focused on tasks that add value to clinical practice by filtering the medical consults, distinguishing those that can be solved online from those needing face-to-face attention [ ] . there has also been improved collaboration with community healthcarespecific groups and services and third-sector agencies such as independent charities. the role of primary care across europe during the covid- pandemic has frequently been limited by the centralization of the crisis in hospital settings, and by the lack of facilities and resources to combat sars-cov- . in a context of economic recession following the shutdown of the european economy, primary care should be strengthened with sufficient resources to cope with the follow-up and detection of new cases of covid- , and also to meet the ongoing needs of comorbid patients. the six countries that participated in this project implemented the general who recommendations in the first or second week of march (fig. ) [ ] . a lack of government planning, the collapse of national health systems, and a scarcity of material and human resources occurred in most of these countries, particularly during march and april . older adults were the most severely affected population in belgium, france, italy, spain, and the uk [ ] , particularly those living in nursing homes (no data available for poland). all authors pointed out the scarcity of material and human resources (fig. ) . in , the international association of gerontology and geriatrics launched the 'global agenda for clinical research and quality of care in nursing homes', which highlighted the general lack of specific medical education in long-term care in most of the european countries and the urgent need to harmonize guidelines across europe [ ] . the special interest group (sig) in long term care of the eugms states that shortcomings reflected in the report have still to be resolved and highlights their negative impact on the management of nursing homes during the covid- pandemic [ ] . unified and targeted actions are required. it would be crucial to provide common guidelines about the protective measures to prevent sars-cov- infections in nursing homes, the priorities (material and human resources) in dealing with outbreaks, the measures for testing and monitoring both older residents and workers, and measures to control infection once it has entered a facility (e.g. isolation protocols) and ensure tailored acute and/or palliative measures for residents with covid- [ ] . belgium, spain and the uk increased their efforts to implement a treatment escalation plans, which included preventive decisions regarding theappropriateness of transfer from nursing homes to hospitals in case of clinical worsening (fig. ) . these decisions were not based on age, but rather on functional status, comorbidities, life expectancy and therapeutic options. in belgium, the assessment of baseline frailty was included in the criteria to transfer patients to hospitals. in the uk, the bgs published a position statement to emphasize the need for using standardized meaningful measures and outcomes such as frailty and function rather than age. older people are a heterogeneous population and need multidimensional policies based on equality, high quality of care and intergenerational exchange to ensure high ethical standards and preservation of personal dignity. it is necessary to involve patients, caregivers, nursing home directors and stakeholders in the decisions that directly affect them, developing patient-and care-centered policies [ ] [ ] [ ] . health care is a basic human right, and access to adequate health resources must be guaranteed for all, regardless of functional state, comorbidities and frailty [ , ] . age discrimination can be seen in this pandemic both in the poor opportunities for participation by older people in the decision-making that affects them and in the inequities in their access to healthcare, where decisions often have been based solely on age [ , ] . the sars-cov- health crisis highlights the need for health decision-making protocols suitable to be applied in clinical practice and based on scientific evidence [ ] . specifying steps to support the transition of the social and health model from disease-focused medicine to person-focused medicine might help to address the unmet needs of older people [ , ] . age has often been identified as the strongest risk factor for negative outcomes in medicine, independent of the context and disease of interest. nevertheless, chronological age is a construct that does not necessarily mirror biology, a concept increasingly recognized but not yet incorporated sufficiently into widespread medical practice. focusing on what really is a result of the aging process (e.g., clinical conditions, physical and mental function) may better estimate the individual's reserves and promote a person-tailored plan of the intervention [ ] . the social distancing measures implemented by the majority of countries to stop the spread of sars-cov- have inevitably had an impact on the older population. both loneliness ( % in women, % in men over living alone) and poor social support have been problems in older populations before, during and after covid- pandemic [ , ] . in an attempt to reduce risks to older people, many hospitals and nursing homes restricted visits, which may also have had an adverse effect on the psycho-cognitive and physical state of older people [ ] . in the community, formal arrangements for social support measures were not always instigated alongside distancing guidance, such as ensuring that home care services and food purchases were not interrupted. however, on a positive note, many communities have come together, charities such as age uk have been invaluable, and some older people are benefiting from an increase in confidence with online and social networking. some of these benefits may be longlasting (fig. ) . the covid- crisis has revealed discriminatory attitudes towards older people due to chronological age [ ] . despite the high pressure on the healthcare system and the availability of resources, decision-making and treatment options should be based on objective ethical clinical guidelines and parameters, and not solely on age. therefore, early identification of older individuals at higher risk by tailored, comprehensive geriatric assessment, along with the overall goal of providing the highest quality of care, should be prioritized over chronological age in clinical decision-making and the development of health policies [ ] . geriatricians need to work together with other medical specialist societies, where some of the ageism is perpetuated, along with older people themselves and society at large, to change these attitudes. our initiative is aligned with the efforts of the un, who and eugms, among others, to share good practice and gather knowledge and data. several predictive models to anticipate the behavior of the disease and counteract this new threat are in progress [ ] . moreover, new methodological approaches, such as the integrated approaches to testing and assessment (iata), which bring together current knowledge in different disciplines might be helpful to gather data and develop safe, efficient therapeutic strategies to combat this disease. the strengths of this work include the interdisciplinary nature of the relatively large number of specialists in geriatrics and primary care physicians from different european groups who reported on their countries' experience, offering a broad point of view of the european healthcare situation during the pandemic from the healthcare professionals' point of view. the authors acknowledge that the reporting is anecdotal, not systematic, may have some biases, and inevitably can only reflect partial observations and reflections of the authors on the needs, actions and policies described. furthermore, the opinion of each medical setting might differ compared to those in another center or region of the country, as many countries have decentralized health systems. • guarantee institutional support for long-term care facilities and develop specific, harmonized european guidelines for the management and hospital referral of older patients with covid- , as well as protocols for action within centers registering positive cases for sars-cov- (e.g., case isolation, staff infection control, visitor restriction policies and hygiene measures). in addition, the supply of ppe, medication stocks and other equipment needed to maintain proper clinical management at these centers should be ensured; if needed, medical support units should be made available both in situ as well as by telematic channels. • ensure access to health resources and avoid diagnostic and therapeutic decisions based solely on age. the involvement of the patient in clinical decision-making should be enforced whenever possible, taking their values, preferences and care goals as the cornerstone (empowerment). in case intensive care hospitalization or mechanical ventilation is needed, decision-making should be individualized and take into consideration aspects such as functional status prior to the onset of acute illness, frailty, life expectancy and co-morbidity. specific guidelines for the management and hospital treatment of older covid- patients should also be considered. • guarantee support for those providing home care services, with similar protection in terms of ppe provision and sick pay [ ] . address the disparities in pay and job security between health care and social care workers. safeguard social support services in an older population, with home assistance or meals and cleaning services, which are often what determine their ability to live alone at their homes. offer systems to avoid social isolation, such as telephone support or apps for social interaction, thus favoring mental resilience and avoiding as far as possible a negative psychological impact of quarantine and social distancing [ ] . promote initiatives for psychological, medical or social support for people with dementia and their caregivers in case the day centers and third sector activities are closed. • support primary care to be the gateway to the health system for new cases of covid- , providing it with diagnostic tools such as rt-pcr and serology for fast diagnosis and contact tracing. the availability of health professionals for the follow-up of chronic diseases should be guaranteed. although we have learned some lessons, there is room to improve with the perspective of a possible second wave of covid- . some of the lessons learned are that the covid- pandemic has hit across our society; however, it has not hit all groups with the same intensity. older people have been the most affected by the virus. this sad reality shows that many of the public policies adopted by different administrations against the covid- pandemic did not adjust to the needs of older adults, a population requiring both inclusive and targeted measures. after the pandemic, key questions will remain as to how prevention or provision of ppe failed, questions which society must answer. points to improve have been identified. one hopes that this pandemic will enable some positive changes in future, both in terms of the value society places on care workers and how we as a society support and treat our older generation. however, much of the narrative around covid- , including the classification of older people as "vulnerable" or recommendations "based on chronological age", may challenge this hope. our goal is to educate healthcare professionals on the scientific evidence behind comprehensive geriatric assessment and biological age in decision-making, and to address widespread perceptions of the predominant importance of chronological age. world health organization ( ) coronavirus disease (covid- ) situation report- . world health organization estimates of the severity of coronavirus disease : a model-based analysis editorial: covid- spiraling of frailty in older italian patients polic y-brief -the-impac t-of-covid - -on-older -perso ns eugms executive board on the covid- epidemic -eugms how the pandemic might play out in and beyond an agency of the european union. covid- situation update for the eu/eea and the uk, as of surveillance of covid- at long-term care facilities in the eu/eea guide méthodologique implementation of the integrated care of older people (icope) app in primary care: new technologies in geriatric care during quarantine of covid- and beyond décision d'admission des patients en unités de réanimation et unités de soins critiques dans un contexte d'épidémie à covid- . societé française d'anesthésie réanimation académie nationale de médecine | une institution dans son temps covid- in italy: impact of containment measures and prevalence estimates of infection in the general population epidemiological characteristics of covid- cases in italy and estimates of the reproductive numbers one month into the epidemic nursing homes or besieged castles: covid- in northern italy covid- in italy: ageism and decision making in a pandemic clinical ethics recommendations for the allocation of intensive care treatments in exceptional, resource-limited circumstances: the italian perspective during the covid- epidemic prognostic indices for older adults: a systematic review medycyna praktyczna ( ) geriatria. list otwarty zarządu głównego polskiego towarzystwa gerontologicznego warszawa: kolegium lekarzy rodzinnych w polsce rekomendacje ptp: epidemia sars-cov- a populacja osób z otępieniem polskie towarzystwo psychiatryczne informe situación covid- en españa a de febrero plan de contingencia frente a la pandemia covid- recomendaciones éticas para la toma de decisiones en la situación excepcional de crisis por pandemia covid- en las unidades de cuidados intensivos-cuidados críticos. recomendaciones sobre limitación. www.semic yuc.org covid- and nursing homes ' crisis in spain : ageism and scarcity of resources . el covid- y la crisis de las residencias de mayores en españa guia d'actuació enfront de casos d'infecció pel nou coronavirus sars-cov- a les residències covid- , adulto mayor y edadismo: errores que nunca han de volver a ocurrir who's at higher risk from coronavirus (covid- )-nhs information for gps advising both shielding and non-shielding patients on support available during the covid- pandemic what is 'shielding' and who needs to do it? -full fact coronavirus: advice to older people about coronavirus (covid- advice on how to establish a remote 'total triage' model in general practice using online consultations government rejected radical lockdown of england's care homes | world news | the guardian sharing insight, asking questions, encouraging collaboration: cqc publishes first insight document on covid- pressures | care quality commission medication management and adherence during the covid- pandemic: perspectives and experiences from low-and middle-income countries telehealth home support during covid- confinement for community-dwelling older adults with mild cognitive impairment or mild dementia: survey study fase de transición de la pandemia por sars-cov- en atención primaria -semfyc clinical and ct features of the covid- infection: comparison among four different age groups international association of gerontology and geriatrics: a global agenda for clinical research and quality of care in nursing homes covid- highlights the need for universal adoption of standards of medical care for physicians in nursing homes in europe could we have done better with covid- in nursing homes? aging in times of the covid- pandemic: avoiding ageism and fostering intergenerational solidarity age alone is not adequate to determine health-care resource allocation during the covid- pandemic covid - and older people in asia: asian working group for sarcopenia calls to actions older people and covid- : isolation, risk and ageism the 'action-research' philosophy: from bedside to bench, to bedside again issue brief on older persons and covid- : a defining moment for informed, inclusive and targeted responseunited nations for ageing | united nations for ageing is it wrong to prioritise younger patients with covid- ? not only virus spread: the diffusion of ageism during the outbreak of covid- publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors gratefully acknowledge elaine lilly phd, for language revisions and unfailing support. oriol miralles · dolores sanchez-rodriguez , , · esther marco · cédric annweiler , , · ainhoa baztan · Évora betancor · alicia cambra · matteo cesari , · benito j. fontecha · jerzy gąsowski · sophie gillain · suzy hope , · katie phillips · karolina piotrowicz · niccolò piro · guillaume sacco , · edoardo saporiti · murielle surquin , · estel vall-llosera key: cord- -j uir ns authors: heymann, david l title: social, behavioural and environmental factors and their impact on infectious disease outbreaks date: - - journal: j public health policy doi: . /palgrave.jphp. sha: doc_id: cord_uid: j uir ns the microbes that cause infectious diseases are complex, dynamic, and constantly evolving. they reproduce rapidly, mutate frequently, breach species barriers, adapt with relative ease to new hosts and new environments, and develop resistance to the drugs used to treat them. in their article “meeting the challenge of epidemic infectious diseases outbreaks: an agenda for research”, kai-lit phua and lai kah lee clearly demonstrate how social, behavioural and environmental factors, linked to a host of human activities, have accelerated and amplified these natural phenomena. by reviewing published and non-published information about outbreaks of nipah virus in malaysia, severe acute respiratory syndrome (sars) and avian influenza in asia, and the hiv pandemic, they provide a series of examples that demonstrate the various social, behavioural and environmental factors of these recent infectious disease outbreaks. they then analyse some of these same determinants in important historical epidemics and pandemics such as plague in medieval europe, and conclude that it is important to better understand the social conditions that facilitate the appearance of diseases outbreaks in order to determine why and how societies react to outbreaks and their impact on different population groups. during the second half of the twentieth century, the impact of social and environmental factors on infectious disease outbreaks has been greatly amplified by the doubling of the world's population, accelerating most rapidly in the developing countries of the tropics and subtropics, where infectious diseases continued to have a hold ( ) . rural-urban migration has resulted in inadequacy of sanitation, crowded living conditions and other basic infrastructure issues associated with population growth. it has thus contributed to the resurgence of many diseases, such as tuberculosis, cholera, typhoid, and plague, that are transmitted when living conditions and hygiene are sub-standard, and when overcrowding occurs. cholera, thought to have been introduced into peru in by bilge pumped from a freight ship, resulted in urban epidemics in peru and parts of latin america where it had previously been quiescent for over years ( ) . by the s, crowded major urban areas in africa and south america had experienced a dramatic re-emergence of yellow fever epidemics as the yellow fever virus was introduced by mosquitoes from rain forests into new and densely populated urban areas where bednets to give protection from mosquito bites were no longer being used, and where mosquito control activities had gone unfounded ( ) . behaviors such as over or under prescribing of antibiotics by health workers, and excessive demand for antibiotics by the general population, have had a remarkable impact on the selection and survival of resistant microbes, rapidly increasing levels of microbial resistance. drug-resistant microbes have then spread from person to person and geographically, raising the prospect that common infectious diseases could become prohibitively expensive or impossible to treat ( ) . the bacterial infections that contribute most to human disease are also those in which emerging resistance is of most concern: diarrheal diseases such as dysentery; respiratory tract infections, including pneumococcal pneumonia and multidrugresistant tuberculosis; sexually transmitted infections such as gonorrhoea; and a host of hospital-acquired infections that are notoriously difficult and expensive to treat. among the major infectious diseases, the development of resistance to drugs commonly used to treat malaria is of particular concern, as is the emerging resistance to anti-hiv drugs. most alarming of all are microbes that have now accumulated resistance genes to virtually all currently available antimicrobial drugs, such as staphylococcus aureus and salmonella typhi, which now have the potential to cause untreatable infections. trends in tourism, with tourists penetrating deep into tropical forests, often without appropriate protection against insect bites or vaccination, result in importations of malaria and yellow fever to industrialized countries ( ) . at the same time, weak infection control procedures by health workers have caused the amplification of transmission in outbreaks such as ebola to health workers and their contacts in sub-saharan africa, and hepatitis and severe acute respiratory syndrome (sars) to health workers and those with whom they have contact in both developing and industrialized counties ( , ) . human disturbance and alternation of ecological zones throughout the world has increased the frequency with which microbes, usually confined to animals, cross the species barrier to infect humans. deforestation disrupts natural habitats of animals, and can force animals, searching for food, into closer contact with humans. outbreaks of lassa fever in west africa and of hantavirus in north america have been linked to such phenomena ( , ) . in latin america, chagas disease emerged as an important human disease after deforestation caused the insect that transmits the infection to move from its wild natural hosts to involve humans and domestic animals in the transmission cycle, eventually transforming the disease into an urban infection that can now also be transmitted by blood transfusion ( ) . climate extremes, whether involving excessive rainfall or drought, can likewise displace animal species and bring them into closer contact with human settlements, or increase vector breeding sites. the outbreak of japanese encephalitis in papua new guinea has been linked to extensive drought, which led to increased mosquito breeding as rivers dried into stagnant pools ( ) . the japanese encephalitis virus is now widespread in papua new guinea and threatening to move farther east. an outbreak of rift valley fever in eastern kenya resulted from flooding related to el niñ o. humans and cattle, forced to live in close proximity on islands of dry land surrounded by water, facilitated the transfer of the rift valley fever virus from unvaccinated animals to humans by mosquitoes that had increased in numbers because of the abundance of pooled-water breeding sites ( ) . other examples of how insects that carry infectious diseases have exploited new opportunities created by environmental degradation and human behavioral change include epidemics of dengue and yellow fever that have been fuelled by the adoption of modern consumer habits in urban areas where discarded household appliances, tires, plastic food containers and jars have created abundant artificial mosquito breeding sites. the aedes mosquito species is now well established in most, if not all, large african cities, increasing the risk of explosive urban outbreaks of dengue ( ) . similar examples are occurring in asia where dengue and dengue hemorrhagic fever have caused major outbreaks during in indonesia and india ( ) . in countries of the former soviet union, large amounts of stagnant water, created by ineffective irrigation schemes, provided mosquito breeding sites that permitted the reemergence of malaria in the most southern states, where a few incidental and probably imported cases in tajikistan in the early s multiplied to almost , reported cases in ( ) . such problems are compounded by the very small number of new costeffective chemical pesticides, suitable for public health, that have been developed in recent years. although intensive research has failed to disclose the origins of marburg and ebola hemorrhagic fever outbreaks, microbes causing both diseases are also thought to be transmitted to humans who encounter animal sources somewhere in the transmission cycle ( ) . an outbreak of ebola hemorrhagic fever in humans in was linked to a woodsman who worked deep within the tropical rainforest making charcoal, and who is somehow thought to have become infected with the ebola virus, which he then carried back to his home village and family members. a swiss researcher is also thought to have become infected with the ebola virus while searching for the cause of a major die-out of chimpanzees in a forest reserve in west africa ( , ) . as phua and lee suggest in their article, the consequences of the environment and interspecies transmission of microbes are most clearly demonstrated in the case of the influenza virus. it is thought to be only a matter of time until an animal influenza virus circulating in domestic animals recombines with a human influenza virus, and causes the next highly lethal influenza pandemic ( ) . intensive farming practices in asia have placed humans in close proximity to domestic animals in densely populated areas. in in the hong kong special administrative region of china, crowded conditions and live poultry markets adjacent to residential areas facilitated the transmission of a new avian influenza a virus (subtype h n ), previously thought to be confined to birds. at least humans were infected and six died, raising considerable alarm ( ) . although human-to-human transmission of the virus was documented, it was found to be relatively inefficient and uncommon ( , ) . a reemergence of this same virus throughout asia in late and has resulted in human infections with deaths in thailand and vietnam by november , and the continued threat of a global human pandemic ( ) . finally, as pointed out by phua and lee, a new infectious disease threat related to social behavior dominates public health thinking and policies in some industrialized countries -deliberately caused infectious disease outbreaks. following the deliberate dissemination of anthrax spores through the us postal system in , questions concerning the deliberate use of biological or chemical weapons have been raised with great urgency. the prospect of introduction of an infectious disease to non-immune populations that could cause severe illness and death has now become a stark reality. infectious diseases have caused human suffering, illness and death throughout written history, and undoubtedly before. the threats posed by infectious diseases today are being amplified by social, behavioral and environmental factors that accelerate the natural phenomena that modify infectious disease patterns. better understanding of these factors through an invigorated research agenda as outlined by phua and lee, and development of evidence-based policies based on this understanding, will help prevent their occurrence and keep them at bay. comprehensive tables. united nations aedes aegypti, dengue and re-urbanization of yellow fever in brazil and other south american countries -past and present situation and future prospects who global strategy for containment of antimicrobial resistance. world health organization: geneva world health organization. airport malaria. world health organization: geneva the reemergence of ebola haemorrhagic fever, democratic republic of the congo sars: a global response to an international threat lassa fever is unheralded problem in west africa update: hantavirus pulmonary syndrome -united states emerging infectious diseases from the global to the local perspective world health organization. outbreak of rift valley fever hunter's tropical medicine and emerging infectious diseases world health organization a view from the ground: tuberculosis as an example of a reemerging infectious disease in the former soviet union marburg and ebola viruses ebola outbreak among wild chimpanzees living in a rain forest of cô te d'ivoire the reemergence of ebola haemorrhagic fever, democratic republic of the congo world health organization. influenza pandemic preparedness plan. world health organization: geneva isolation of avian influenza a(h n ) viruses from humans -hong kong human influenza a h n virus related to a highly pathogenic avian influenza virus avian influenza update the world health organization has granted palgrave macmillan permission for the reproduction of this article key: cord- -vo bemg authors: ryan, jeffrey r. title: case studies date: - - journal: biosecurity and bioterrorism doi: . /b - - - - . - sha: doc_id: cord_uid: vo bemg chapter presents six case studies that should provoke the reader to delve more into the particulars of each incident. specifically, the chapter provides details on the sverdlovsk anthrax incident ( ); the rajneeshee salmonella incident ( ); the surat, india pneumonic plague outbreak ( ); the fallen angel ricin incidents ( – ); amerithrax ( ); and the outbreak of ebola virus in west africa ( – ). each of these incidents help illustrate the difference between an unusual natural outbreak and one due to an intentional act. in addition, each case study presented herein shows how confounding these outbreaks can be to public health officials and how fear, panic, and social disruption may ensue. the six case studies presented within this chapter should be viewed as drawing attention to weaknesses in a system of detection first, followed perhaps by issues in containment and mitigation as a result. in looking at these events from a system perspective, we should be aware that the point at which a system fails is often a weakness due to failure in other parts of the system. a system is defined as "a dynamic order of parts and processes standing in mutual interaction with each other" (von bertallanfy, ) . therefore it is necessary for all professionals reading this text to examine all of the parts and processes, especially the interactions among the parts. the manner in which the case studies are presented in this chapter runs the risk of being categorized as anecdotal and, as such, dismissed by some purists. it is not practical for us to completely recreate or chronicle the accounts for the case studies presented here, and more elaborate and definitive references are easily retrieved from open sources. as such, references and websites are provided at the end of the chapter to allow additional, in-depth exploration of the described events. early detection of biologic events requires an innate ability to make sense of seemingly subtle and random events, often lacking scientific explanation. the practice of medicine is an example of the need to combine science, experience, and instinct in the development of a plan of action. rarely do patients themselves progress in clinical presentation and disease etiology as the pages in a textbook might suggest. in , sacks wrote that we need, in addition to conventional medicine, a medicine of a far profounder sort, based on the profoundest understanding of the organism and of the life. empirical science is the key to one form of knowledge, the generalized knowledge that gives us power over nature; the key to wisdom however, is the knowledge of particulars. we anticipate that the reader will filter and interpret this material within the context of his or her chosen vocation. applying some of these lessons may allow future generations, regardless of their particular vocational path, to detect early on the emergence of a biologic event and conceivably achieve improved outcomes. herd health and wellbeing may take precedence over individual rights and outcomes. no doubt this is a hard pill for some to swallow. however, improved outcomes portend a decrease in morbidity and mortality, minimization of social or economic impact, or perhaps even decreased international interest. in april an unusual epidemic of anthrax occurred in sverdlovsk, a city of . million people km east of moscow in the former soviet union (meselson et al., ) . shortly after the cases emerged, soviet officials explained that the source of the outbreak was related to the ingestion of contaminated meat. according to their report, contaminated animals and meat from an anthrax epizootic south of sverdlovsk caused cases of human anthrax (meselson, ) . of these cases, were cutaneous anthrax and were gastrointestinal anthrax. of the cases, of the gastrointestinal anthrax cases were fatal. at the time, there was great debate among officials from other nations as they tried to determine if the outbreak may have actually been due to covert soviet bioweapons production. the following report comes from a recently declassified defense intelligence agency's intelligence information report dated march , : a fourth source reports in late april , the population was awakened by a large explosion that was attributed to a jet aircraft. four days later, seven or eight persons from the military installation were admitted to hospital number in the suburbs where the military installation is located. their symptoms were high fever ( °), blue ears and lips, choking, and difficulty breathing. they died within - h, and autopsies revealed severe pulmonary edema plus symptoms of a serious toxemia. about days after the illness first appeared, the source and other doctors from various hospitals were called together by the district epidemiologist. the number of fatalities had risen sharply, and the source estimated deaths by this time at . the epidemiologist announced the outbreak of an anthrax epidemic and gave a lecture on the disease. he claimed the epidemic was caused by an illegally slaughtered cow suffering from anthrax in a town about km northeast of sverdlovsk. he said the beef had been sold in the suburb where the fatalities were occurring. this explanation was not accepted by the doctors in attendance because the fatalities were caused by pulmonary anthrax as opposed to gastric or skin anthrax, which would be more likely if anthraxcontaminated beef were eaten or handled. as more reports emerged, us intelligence reviewed satellite imagery and signal intercepts from the spring of and found corroborative signs of a serious accident. this included roadblocks and decontamination trucks around what was then known as compound , a military installation in sverdlovsk. in addition, officials learned that the soviet defense minister had visited the city shortly after the incident. the anthrax explanation also seemed plausible given the long-standing history of soviet efforts to mass produce bacillus anthracis into a biological weapon (wampler and blanton, ) . us intelligence agency officials believed that the incident had to be due to inhalation of spores that were released from a secret bioweapons plant in the city. victims presented with severe respiratory distress and died within a few days of the onset of symptoms. this belief came from epidemiological data showing that most victims lived or worked in a narrow zone extending from the bioproduction facility to the southern city limit. furthermore, livestock downwind from the point of release died of anthrax along the same zone's extended axis. the zone paralleled the northerly wind that prevailed shortly before the outbreak (meselson et al., ) . other scientists harbored doubts about the official us accusation, noting that an accidental release of anthrax spores could have been in connection with a defensive biological warfare research program, which was allowed under the convention. it was later concluded that the escape of an aerosol of anthrax pathogen at the military facility caused the outbreak. the reports of a possible anthrax outbreak in sverdlovsk, linked to an incident at a suspected soviet biological warfare facility, served to further deepen already worsening us-soviet relations, which were heading back toward a new cold war in the wake of the soviet invasion of afghanistan. in the s during the reagan administration, sverdlovsk would become one of the major points in the us indictment of the soviet union to build the case that the soviets were violating the ban on the use of biological weapons imposed by the biological warfare convention, which both the united states and the soviet union had signed. despite the proof that western scientists had, the soviets (see fig. . ) refused to discuss the incident and maintained their position that they did not have a program in bioweapons development and production. in fact, the strain of anthrax produced in military compound near sverdlovsk was believed by experts to be the most powerful in the soviet arsenal ("anthrax "). could there be legitimate national security reasons for not disclosing the source of such an outbreak? if there are reasons, what are the potential ramifications for recognition, containment, and mitigation of the danger from the organism? the final breakthrough did not come until after the soviet union had ceased to exist, at the end of , and boris yeltsin came to power as the new head of the russian government. yeltsin had a personal connection to the sverdlovsk issue because he had been communist party chief in the region at the time of the anthrax outbreak, and he believed the kgb and military had lied to him about the true explanation. at a summit meeting with president george h. w. bush in february , yeltsin told bush that he agreed with us accusations regarding soviet violation of the biological weapons convention and that the sverdlovsk incident was the result of an accident at a soviet biological warfare installation, and he promised to clean up this problem. in a may interview yeltsin publicly revealed what he had told bush in private: we have now circumscribed the time of common exposure to anthrax. the number of red dots we can plot on our spot map places nearly all of the victims within a narrow plume that stretches southeast from compound to the neighborhood past the ceramics factory…. we have clarified the relation of the timing of animal and human deaths and believe the exposure for both was nearly simultaneous. all the data-from interviews, documents, lists, autopsies, and wind reports-now fit, like pieces of a puzzle. what we know proves a lethal plume of anthrax came from compound . the sverdlovsk incident represents one of the leading examples of how an unknowing population can be affected by the release of formulated biological agents. it seems pretty clear at this point that the release was accidental. however, questions remain unanswered as to exactly how much b. anthracis was released, how far down range did it travel, and how many people were affected by the release. on september , , a man was admitted to the county's only hospital complaining of intense stomach cramps, nausea, and high fever. two friends were also ill. all three had eaten at a local restaurant earlier that day. in the following week, employees and dozens of customers of the restaurant became violently ill. many called and threatened to sue. within h after the first patient presented to medical professionals, a pathologist at mid-columbia medical center had determined the cause was food poisoning from salmonella bacteria. however, it was a full week before the first complaint of this foodborne outbreak was reported to the county health department. by september , reports of new cases had subsided; the state laboratory had identified the strain of salmonella used. that is when the second wave struck. two days later every bed in the local hospital was filled with salmonella victims. almost one-third of the town's restaurants were implicated ( in all). this was enough to basically shut down the economy of the dalles; many of these restaurants would close forever. on september the local health department called in assistance from the centers for disease control (cdc). by the time the first cdc officers began to arrive, the county health department had already confirmed cases of salmonella enterica serotype typhimurium from the outbreak. they had also found the main epidemiologic connection: most of the sick people had eaten from salad bars. by the time the cdc arrived in force the county health department had already done the main work involved in stopping the outbreak. • the local public health office began immediately tracking patients through passive surveillance. three-day food histories were completed for each patient. these interviews quickly showed that most of the ill people had eaten at a salad bar at one of the affected restaurants. restaurants were asked to close their salad bars; all restaurants in the county immediately complied. • colleagues were interviewing and inspecting restaurants in the county. however, they found nothing that would indicate how restaurants had created a single outbreak using the exact same pathogen. • they found that the affected restaurants used several distinct suppliers, and no supplier served more than restaurants. in addition, the epidemiologic investigation found that various foods were risk factors at various times. the first wave of illness centered on items such as potato salad; the second wave on blue cheese dressing. no major violations were found in the distributors or suppliers. • samples were taken from both water systems that served the area restaurants, from the restaurants themselves and at the municipal level. these samples were negative for any form of bacteria, and all had acceptable color and chlorine levels. despite the suspicions of the community and the lack of any other explanation, an epidemiologic investigation failed to demonstrate that the outbreak was deliberately caused. the state did not want to be considered backward or insensitive to the rajneeshees, and the investigation may have been influenced by such political pressure and would hold to a theory of multiple coincidental cross-contaminations throughout the county. the rajneeshees incident occurred in . however, had this event occurred after the anthrax attacks, do you think investigators would be so quick to discount an intentional attack? many years have passed since the attacks; do you think our vigilance has a shelf life? in all, cases of salmonellosis were confirmed from more than patients; approximately % of the community became ill. although the illness struck simultaneously in restaurants dispersed throughout the county, the state health department's epidemiologic investigation concluded that the outbreak was caused by unsanitary hand-washing practices at the restaurants involved. an initial criminal investigation agreed with the health department's conclusion. one year later a representative of the bhagwan shree rajneesh sect, which had a ranch in the county, announced that members of that sect had poisoned local salad bars with salmonella bacteria in a test run for a plan to influence local election results in the sect's favor ( fig. . ). a subsequent criminal investigation found that the sect had ordered the exact strain of salmonella used by mail from a licensed commercial laboratory company. when the cdc analyzed the data, things looked much different. employees generally had symptoms at the same time as customers, and the strain of salmonella encountered was not at all the same as any other area cases in recent years. the outbreak occurred in two distinct waves that flew in the face of a single-exposure event. in this case the initial state health report denied local law enforcement the probable cause they needed to open an investigation. even in the face of strong evidence suggesting a deliberate attack, investigators initially discounted this theory, giving several reasons why they reached this conclusion. among the reasons were these: there was no apparent motive, no one claimed responsibility, and nothing like this had ever occurred before. these points reinforce the need to maintain a high index of suspicion and follow epidemiological clues to reach a plausible explanation of any unusual outbreak. early involvement of law enforcement personnel may enable investigators to remain subjective in their determination and cognizance of evidentiary matters should a reasonable index of suspicion be warranted. had investigators used more aggressive surveillance techniques to gather more information (ie, surveying doctor's offices for symptomatic persons), they may have received additional information for the investigation and might have produced enough evidence to change the investigator's position on whether the outbreak was accidental or intentional. accounts from community members support the position that numerous patients did not report to the medical community and chose to stay home and treat themselves (personal communication, j. glarum). the population of surat, in the western state of gujarat, boomed shortly after world war ii. surat's population grew from , to approximately . million residents. the city divided into two parts, the "old city," or city center, remained the most heavily populated area, accounting for % of the total population. the newer settled, outer portions of the city were characterized by their universal lack of planning. incorporating a mix of industry and lower class residences, these areas were largely devoid of proper sewage facilities and only % of total daily garbage produced was regularly collected (shah, ) . less than half of the city had access to treated drinking water. the unhygienic conditions and poor working conditions within surat were commonly identified by public health officials as the causes for regular epidemic outbreaks within the city of malaria, gastroenteritis, pneumonia, and diarrhea. in september an earthquake occurred, which killed an estimated , people, and because of the poverty of the area, many of the dead were not properly buried. floods in august created an unbelievable mix of human waste, refuse, and human and animal remains left behind. these events, in addition to the poor refuse disposal and sewer services, created an abundant food supply for rats and other vermin. some reports point to a possible precursor event, which involved the die-off of rats in mamala village to such an extent that they were "falling off rafters, dead, in great numbers" (john, ) . by mid-september, despite the available epidemiological clues, % of the village population was ill with bubonic plague. the indian government initially appeared unable or unwilling to mitigate the spread of the disease created by a series of events in and outside of the country. poor crisis communication regarding the outbreak caused the population to take measures to keep themselves safe in the areas affected and chose to leave, potentially carrying disease with them to unaffected areas. contact tracing was not initially accomplished, once more leading to spread of disease. once the disease became obvious and there was little being done by the government to contain it, panic ensued and more people fled, carrying the disease. it has been estimated that % of the . million people fled the area. a cordon sanitaire (a french term that translates to "sanitary cord." it is used to denote an extreme use of quarantine in which public health authorities implement large-scale quarantine measures to contain the spread of disease. in this case, a small section of the city would have been under quarantine order. as one might imagine, this would be difficult to implement and enforce) may have proven useful in plague containment; however, it would have affected india's diamond-cutting and silk-production center in the area of the slums. sealing off this area from the rest of the city would have prevented workers getting to the factory, cutting off their income, as well as slowing production (see fig. . ). in addition, the encroachment of the holiday season with the associated visitors and large conferences with international guests drawing thousands of international tourists were planned, and tourism is one of india's major financial businesses. this is a similar situation to china's dilemma on dealing with the outbreak of severe acute respiratory syndrome. several countries put restrictions on travelers from india, with moscow imposing a -day quarantine for all visitors from india and banning all travel to the country. estimates for business losses for the city of surat alone were over $ million. it has been estimated that india lost more than $ billion in export earnings and - % of its anticipated tourism (steinberg, ) . several million people lost income when they were unable to work, locally or internationally; many more millions suffered panic, fear, or dislocation. thousands of squatters had their dwellings inspected and condemned. as a nation, india found its modernity, its efficiency, its health administration, and its local governance called into question. locally, agricultural exporters saw their share prices tumble as some foreign countries not only refused indian exports but closed their borders. the united arab emirates was reported to have cut off postal links with india out of fear that the plague would spread via mail. given the economic upheaval, it is interesting to note that approximately people fell ill, with the total death toll only . this is the point: fear and panic due to poor risk communication and appropriate containment measures caused the bigger problems for the financial markets and economy than the actual disease. control of this disease outbreak would have had to include selective quarantine, contact tracing, treatment, and prophylaxis as well as elimination of potential vectors and animal hosts. in hindsight, investigators identified a -year-old man on september as the first case. he had been admitted to a hospital days earlier with respiratory symptoms and fever (shah, ) . over the next week or so, through september , approximately individuals were admitted to various hospitals, mostly to be diagnosed with and treated for malaria. not until september did the presumption of plague surface. public health authorities were alerted, word began to spread through the medical community, and the one hospital was designated for new suspected plague admissions. shops began closing in the most heavily affected region of the city, medical practitioners began to leave the city, and local pharmacies sold out of available tetracycline. hospital admissions continued to grow and public health authorities were barely able to locate sufficient antibiotics to treat the ill and their care providers. within weeks the case-fatality rate had dropped from % to below %. until adequate government supplies of tetracycline begin to arrive, approximately % of surat's population fled, businesses closed, and public facilities (schools, swimming pools) shut down. by the end of september, adequate supplies, plans, and personnel had the epidemic under control (shah, ) . modern public health and medicine are capable of intervening effectively in outbreaks of bacterial diseases, such as plague, through combinations of medical screening, immunization, antibiotic treatment, and supportive care. even in the absence of effective medical intervention, proper behavior, such as contact avoidance, can profoundly alter the disease progression cycle. if any measure is overlooked or botched in its implementation, it is easy to see how containment can be slow or nonexistent. in late september an avid outdoorsman whose pastimes were gardening and fishing left for a short vacation in north carolina. his job as a photo editor required that most of his work time was spent reviewing photographs submitted by mail or over the internet, so no doubt he looked forward to this trip. soon after arriving in north carolina, the first symptoms of illness developed; these included muscle aches, nausea, and fever. the symptoms waxed and waned for the duration of the three-day trip. the day after he returned home he was taken to the hospital for medical evaluation at the emergency department of a florida medical center after he awoke from sleep with fever, emesis, and confusion. because he was disoriented at the time of his presentation at the hospital, he was unable to provide further relevant information. treatment with intravenous cefotaxime and vancomycin was initiated for presumed bacterial meningitis while the patient awaited a lumbar puncture (malecki et al., ) . on physical examination he was found to be lethargic and disoriented. his temperature was °c ( . °f), blood pressure was / mmhg, pulse was , and respirations were . no respiratory distress was noted; his arterial hemoglobin saturation, as indicated by pulse oximetry while he was breathing ambient air, was %. examination of the ear, nose, and throat detected no discharge or signs of inflammation. chest examination revealed rhonchi without rales (bush et al., ) . the initial chest radiograph was interpreted as showing basilar infiltrates and a widened mediastinum (see fig. . ). the results of a computed tomography scan of the head were normal. a spinal tap was performed under fluoroscopic guidance within hours after presentation at the hospital and yielded cloudy cerebrospinal fluid. the patient was admitted to the hospital with a diagnosis of meningitis. after a single dose of cefotaxime (a broad-spectrum cephalosporin) he was started on multiple antibiotics. a short time later he had generalized seizures and was intubated for airway protection. the next day a new array of antibiotics was initiated, replacing those previously prescribed. he remained febrile and became unresponsive to deep stimuli. his condition progressively deteriorated, with hypotension and worsening kidney function. the patient died on october . autopsy findings included hemorrhagic inflammation of lymph nodes in the chest as well as disseminated b. anthracis in multiple organs (bush et al., ) . gram staining of cerebrospinal fluid revealed many polymorphonuclear white cells and many large gram-positive bacilli, both singly and in chains. on the basis of the cerebrospinal fluid appearance, a diagnosis of anthrax was considered, and high-dose intravenous penicillin g was added to the antibiotic regimen. within h after plating on sheep blood agar the cultures of cerebrospinal fluid yielded colonies of gram-positive bacilli. the clinical laboratory of the medical center presumptively identified the organism as b. anthracis within h after plating; this identification was confirmed by the florida department of health laboratory on the following day. it was evident that making a diagnosis of anthrax would have serious ramifications. although the case was reported to local public health authorities when anthrax was first suspected, final laboratory confirmation of the diagnosis was awaited before a public announcement was made. extensive environmental samples from the patient's home and travel destinations were negative for anthrax. moreover, the finding of b. anthracis in regional and local postal centers that served the work site implicates one or more mailed letters or packages as the probable source of exposure (see fig. . ). coworkers report that the patient had closely examined a suspicious letter containing powder on september , approximately days before the onset of illness. this index case highlights the importance of physicians' ability to recognize potential cases in the identification and treatment of diseases associated with biologic terrorism. on the basis of your knowledge of inhalation anthrax, how does the clinical presentation from the index case measure up with the incubation period and final outcome? in summary, officials believe that there were a total of five letters mailed, four of which were recovered. there were two known mailing dates, september and october , . the letter to the ami building in florida (see fig. . ), where the index case originated, was not recovered. the september letters went to the offices of nbc studios and the new york post in new york city. the october letters were mailed to senators daschle and leahy of the us senate. the amount of formulated anthrax spores in these letters was estimated to be - g. the letter to senator leahy (which was unopened at the time it was discovered) contained approximately g of highly weaponized anthrax spores. outbreaks of the disease were concentrated in six locations: florida; new york; new jersey; capitol hill in washington, dc; the washington, dc regional area, including maryland and virginia; and connecticut. the anthrax incidents caused illness in people: with the cutaneous (skin) form of the disease and with the inhalational (respiratory) form, of who died. demands on public health resources reached far beyond the six outbreaks of disease. once officials realized that mail processed at contaminated postal facilities could be cross-contaminated and end up anywhere in the country, residents brought samples of suspicious powders to officials for testing and worried about the safety of their daily mail. in dealing with this crisis, there were deficiencies in the local public health response and the federal government's ability to manage it. public health officials did not fully appreciate the extent of communication, coordination, and cooperation needed among responders. there were difficulties in reaching clinicians to provide them with guidance. the federal bureau of investigation (fbi) reached a conclusion in that the sole perpetrator was dr. bruce ivins, an army biodefense research scientist assigned to the us army research institute of infectious diseases, fort detrick, md. the conclusion of the fbi's investigation has been viewed by some experts as being technically flawed; therefore it is controversial. in october a suspicious letter addressed to the us department of transportation was intercepted by us postal inspectors. upon examination of the letter's contents postal inspectors recovered a warning: a metal vial containing ricin and a note threatening more attacks if laws restricting the activities of commercial truck drivers were not amended (see fig. . ). in february ricin was discovered in senator william frist's office in the dirksen office building. after the toxin was discovered in a letter-opening machine in the senator's office, federal investigators examined some , pieces of mail, hoping to find the source of the ricin, but turned up nothing to lead them to a suspect. they were unable to determine whether the ricin had been there for hours, weeks, or even months before it was discovered by an intern in the office. conflicting reports on the handling of the response emerged. some senate employees described the hours after the toxin was found as confused and chaotic. some employees near dr. frist's office went home with no medical screening after the substance was found, and others went about their activities without being advised to seek decontamination. the authorities said the substance was first seen about : pm on monday when a hazardous materials team was dispatched to dr. frist's offices in the dirksen senate office building. after preliminary tests proved negative, an all-clear was given. such an occurrence is not unusual for congressional offices, which frequently receive suspect mail that turns out to be harmless. what is the risk to overreacting and carrying out containment activities every time a suspect item is discovered at government offices? when follow-up tests detected the presence of ricin, the capitol police returned and began evacuating people to another area of the dirksen building. by that time, staff members who were present said that many people had left for the day. those who had been in the vicinity and remained in the building were directed to shower at a decontamination tent erected in a hallway between the dirksen building and the adjacent hart senate office building. there they were interviewed by the police and allowed to go home. investigators have found nothing to explain how the potentially deadly powder wound up in the offices of the senate majority leader. the investigation focused on a mysterious "fallen angel," who threatened to use ricin as a weapon unless new trucking regulations were rolled back. no obvious direct connection between the frist case and the letters signed by fallen angel has been found (see fig. . ) . those letters were discovered in mail facilities that serve the greenville-spartanburg international airport in south carolina and the white house. in early the world was introduced to the largest outbreak of ebola virus disease (evd) ever known. according to researchers, the index case for this outbreak came from a -year-old boy in the small village of meliandou (guéckédou province), in the west african nation of guinea. the researchers learned that children in meliandou had been playing near the hollow of a large, dead tree. the tree had a colony of bats. the bats were believed to be infected with ebola virus (marí-saéz et al., ) . this has relevance because of what is currently believed to be the role of bats in the epizootic transmission cycle of ebola virus (see fig. . ). we also know that the -year-old boy mentioned previously died from a mysterious febrile illness, which spread throughout his family, to other villagers and then outside his village. on march , , the world health organization (who) was notified of an outbreak of evd in guinea. by that time it had spread to neighboring african countries (liberia, nigeria, senegal, and sierra leone). limited public health resources (see fig. . ) and volunteer medical groups worked to quell the quickly spreading epidemic, but they were overwhelmed by the number of patients and patient contacts. it was not until august , , that the who declared the epidemic to be a public health emergency of international concern (who report, ). this begs the obvious question, "why did it take nearly months to make such a declaration?" on september , , a liberian national, thomas eric duncan, made his way from liberia to houston, texas. before getting on the plane in liberia, mr. duncan assisted an ill pregnant woman by helping her out of a taxi and into a hospital. it is believed the woman was an evd patient, but he was not aware of this. regardless of what he knew, mr. duncan arrived in houston feeling well with no fever or other symptoms. six days later mr. duncan felt very ill, which prompted him to seek medical attention at a hospital in houston, texas. his travel history was not discussed at that time, so he was discharged from the emergency room (er) with some antibiotics for what was believed to be a routine illness. he went back to the apartment, and a few days later his condition was so severe that he reported to the er at texas health presbyterian hospital in dallas where it became apparent that he was a suspect evd patient. he was admitted to the intensive care unit and ended up in an isolation ward. his condition worsened and he later died. unfortunately, infection prevention standards at the hospital were not entirely adequate. this resulted in two nurses (nina pham and amber vinson) being infected with ebola virus. they were both treated successfully and fully recovered weeks later. the media and public reaction to the three cases in the united states (duncan, pham, and vinson) was pronounced. numerous politicians took a stance on mandatory quarantine procedures at the state and federal level. national and local media providers sought to hold the public's constant attention on the serious nature of "the deadly ebola virus." it is safe to say that there was fear and some panic because of the politicization and dramatization of this limited outbreak. meanwhile, state and local officials in texas had an incident on their hands. emergency management and public health agencies had to work together to ensure that the apartment where duncan had been staying did not become the cause of more infections. all of mr. duncan's contacts had to be identified, placed under strict quarantine, and monitored. after their quarantine period the apartment became a hot zone that required thorough decontamination by a commercial hazmat clean-up group, cleaning guys, llc (refer to fig. . ) . none of mr. duncan's contacts outside of the hospital became infected and the apartment he resided in and all its contents were rendered safe using technical decontamination procedures. what has the - evd outbreak taught us about a few cases of viral hemorrhagic fever getting into the united states or any other developed country? consider applying the criteria for category a agents. at the time of the preparation of this chapter, the outbreak had not been completely contained. as of august there have been a total of , confirmed cases with , fatalities (who sitrep ebola summary; august , ). currently, the outbreak is confined to just one country in west africa: the putative source of the outbreak, guinea. the fear is that evd is now endemic in this region, with case numbers fluctuating with the seasons, but always there. the evd outbreak in west africa was unprecedented in its scale and impact. out of this human catastrophe has come renewed attention to global health security-its definition, meaning, and the practical implications for programs and policy. for example, how does a government begin to strengthen its core public health capacities as demanded by the international health regulations? what counts as a global health security concern? in the context of the governance of global health, including who reform, it will be important to distil lessons learned from the ebola outbreak. the lancet invited a group of respected global health practitioners to reflect on these lessons, to explore the idea of global health security, and to offer suggestions for next steps. their contributions describe some of the major threats to individual and collective human health as well as the values and recommendations that should be considered to counteract such threats in the future. many different perspectives are proposed. their common goal is a more sustainable and resilient society for human health and well-being (heymann et al., ) . what will make for an interesting postoutbreak study are the geopolitical implications of a largescale outbreak of a category a agent, such as ebola hemorrhagic fever. remember that we will always be one simple border crossing or international flight away from the beginning of the next outbreak. the six case studies briefly presented here should provoke the reader to delve more into the particulars of each incident. the sverdlovsk anthrax incident illustrates the danger posed by bioweapons production. a seemingly simple accident involving the release of a small amount of formulated agent can have a dramatic effect. imagine if the same thing occurred in the united states or europe in the information age of which we are all part today. the rajneeshee incident involving the intentional contamination of food with bacteria was the largest act of bioterrorism to occur in the united states. acquisition of the agent, the ease of production, and the covert and simple nature of the attack emphasizes the indiscriminate and insidious nature of biological terrorism. despite the best efforts of many people, it took more than a year and a confession of guilt from the perpetrators to convince officials that the incident was intentional. the outbreak of pneumonic plague that took place in surat, india, is a testimony to the importance of fast and decisive action to contain a natural outbreak of a highly contagious and deadly disease. had this been related to an intentional act there would have been more index cases or victims initially to facilitate widespread disease. this emphasizes the importance of early detection and standard procedures for containment. the amerithrax incident of showed us how vulnerable a nation is to a small amount of formulated biological material. looking back on that time, the events, as they unfolded, seemed surreal. it was hard to believe that we were under attack and no one really knew for some time how widespread it was or when it would end. many have criticized public officials for how they handled or mishandled the event. however, we believe that public health officials moved quickly to disseminate information and increase the awareness of the public (potential victims) and the vigilance of healthcare providers (alert guardians). because of numerous evil documents circulated on the internet, ricin production, possession, and dissemination now fits nicely into the toolbox of every amateur bioterrorist. keeping things in perspective, ricin, in its crudest forms, is not a formidable threat, but it is deadly if delivered to the potential victim in the right way. its production, possession, and dissemination are illegal and deserving of a rapid and formidable response. persons that break these laws should be prosecuted to the fullest extent of the law. the massive evd outbreak of points out just how vulnerable underresourced countries are to hemorrhagic fever viruses. once the genie is out of the bottle, so to speak, it is hard to put him back in. lessons learned from this incident will point to the importance of global surveillance and health security. the "international community" will have to act more quickly to resource and assemble the teams of experts needed to quell the next outbreak in its early stages. once a viral hemorrhagic fever leaves a small village and moves into a large metropolitan area, public health control measures become extremely difficult, if not impossible. our hope is that evd does not remain endemic in west africa. those countries affected will take years to recover economically from the outbreak. • cluster. a grouping of health-related events that are related temporally and in proximity. typically, when clusters are recognized they are reported to public health departments in the local area. • cordon sanitaire. a french term that translates to "sanitary cord." it is used to denote an extreme use of quarantine in which public health authorities implement large-scale quarantine measures to contain the spread of disease. in this case, a small section of the city would have been under quarantine order. as one might imagine, this would be difficult to implement and enforce in a modern setting. • fomite. any inanimate object that can mechanically transmit infectious agents from one host to another. • does it seem to matter if an outbreak is derived from a natural, accidental, or intentional event? in what ways are they equivocal? in what ways are they different? • with reference to the initial response, does it matter whether an outbreak is natural, accidental, or intentional? if yes, how does it matter and to whom? if not, why not? • would automated biosensor programs increase, decrease, or have no effect on the vigilance of medical practitioners presented with unusual disease outbreaks? anthrax at sverdlovsk lessons learned from a full scale bio-terrorism exercise indian "plague" epidemic: unanswered questions and key lessons in their own words: lessons learned from those exposed to anthrax index case of fatal inhalational anthrax due to bioterrorism in the united states general system theory possible bw accident near sverdlovsk global health security: the wider lessons from the west african ebola virus disease epidemic learning from plague in india update: investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy investigating the zoonotic origin of the west african ebola epidemic the sverdlovsk anthrax outbreak of the biological weapons convention and the sverdlovsk anthrax outbreak of federation of american scientists public interest public health and urban development: the plague in surat indian cities after the plague-what next? intelligence on the deadliest modern outbreak. national security archive electronic briefing book no. world health organization ebola virus disease in west africa -the first months of the epidemic and forward projections key: cord- -nd ozu w authors: furr-holden, debra; carter-pokras, olivia; kimmel, mary; mouton, charles title: access to care during a global health crisis date: - - journal: health equity doi: . /heq. . .rtl sha: doc_id: cord_uid: nd ozu w nan access to care has been an ongoing health care issue for socially and economically disadvantaged populations in the united states for many decades. the recent covid- pandemic has highlighted these disparities as people of color suffer disparate mortality and face growing inequities in care. this moderated panel discussion provides a broad insight into these issues and discusses the need for greater attention to the access to care problem for many u.s. communities. dr. debra furr-holden: thank you all for joining on this roundtable discussion about health equity and access to care. to start our conversation, i would love to hear from each of you about what you see as the current highest priorities regarding access to care. dr. olivia carter-pokras: in preparation for this discussion, i reached out to other members of the latino health steering committee from montgomery county, maryland, because we are a mix of academics as well as health care providers and others, so i wanted to bring in voices other than just my own. at the time of this discussion, we are dealing with the covid- pandemic. there are many factors that can result in lower access and quality of care received by racial and ethnic minorities, in general, and specifically for those with covid- infection. [ ] [ ] [ ] these factors can include not knowing where to go for testing or where to get care, for instance, as well as the ability to pay, transportation to get there, and whether or not the person has a usual health care provider (referral is often required to receive testing). the lack of interpretive services continues to be a big issue. only about half of foreign-born latinos in maryland have health insurance, even though maryland is ranked second in the nation in median household income. , health issues are interrelated with other problems such as unemployment and stress. these are long-standing concerns that have only been exacerbated by the coronavirus pandemic. on top of that, we have individuals who are undocumented and afraid to seek care. as we learned after / , many are ''frightened because we don't know what is going to happen (with immigration).this is an emergency.'' that fear certainly is coming into play with people who, even if they have the signs and symptoms, even though they are very ill, are refusing to go in for care. many of them were afraid to leave their homes even before all of this happened because of that fear. immigrant workers are a significant share of essential workers these days, from staffing grocery stores to cleaning hospital rooms and transporting food. although % of civilians working in were foreign born, it is a much larger percentage when you look specifically at workers on the front line. immigrant workers are also overrepresented in jobs that are currently shuttered, such as hotels and restaurants, cleaning services, personal services, and hair and nail care. lack of income right now is a big issue and a major disparity during this crisis. language is still an issue when trying to figure out where to go for testing; information on testing has mainly been available only in english. and finally, inconsistent messaging continues to be a major challenge. i think we learned a lot in the past about not sufficiently dealing with health literacy. when we think about who should get tested, we get one message from the cdc, one message from the state, and one message from the county health department, but none of them are consistent, and, frankly, misinformation within our communities has been shared by the mainstream media as well as through social media. for instance, using neosporin in the nose to help prevent getting the virus was one piece of misinformation that was spread early on. these issues existed before covid- , such as the lack of insurance and the lack of interpretation and translation of materials, but the pandemic has compounded the problem significantly. dr. mary kimmel: i want to talk about mental health priorities regarding access to care. building upon what dr. carter-pokras just talked about, the same stressors are still there, and the same issues are still there, but now things are magnified. i actually hope that one silver lining would be that we can learn from these issues and figure out how to handle some of them. we are seeing that with mental health. we already had many people who did not feel able to talk about their mental health or mental wellness. and i like the term ''mental wellness,'' because when i say ''mental health,'' people often think of that as illness. i really want us to start thinking about mental health and wellness as our mental life, which includes for all us all the things we manage, our relationships, the stress we manage such as from limited finances and access to food and housing and health care. so those things were already there, and people already did not feel they could always talk about how they were feeling and their emotions and how they were managing stressors and afraid what people would think if they did talk about how they are managing stressors. but now, i think the good thing about this crisis is that people are acknowledging that this is highly stressful and that this is something that is going to make other people very stressed too. going forward, i anticipate that we are only going to see increases of this reflection on some of the things in the news and thinking about the number of people who are being impacted by this in different ways, either by family members being ill, being afraid that they are ill and not knowing, not knowing whether they are going to infect their families, and just the trauma of all this is going to be longstanding. one nice thing is this has really propelled us forward in terms of telehealth. i am the medical director for a program called north carolina maternal mental health matters, and that program provides education to frontline providers, such as obstetricians and family practice physicians and pediatricians, to help them support mental health in their patients. but through that, we also had intended to pilot a telehealth assessment that we could do to support primary care providers with psychiatric assessment. owing to new support for telehealth, we have been able to move forward with these telehealth assessments. whereas this was previously taking a while to get going, are now being pushed forward, and payers are now saying this is something they are going to pay for. going forward, we need to work to say that those things are important, and we should continue those things even after the immediate need is gone. but i also, from that, have found some of the inequity. i certainly have worked with patients who are supposed to be doing our visits through our medical records system but are experiencing access challenges. some patients cannot access the internet, and they do not have the bandwidth to do that kind of visit. i have done phone visits with some patients, and i really hope that we can also move that forward as an option when video visits for mental health support are not possible. that has historically been something that has not been compensated as well, to do phone visits, and i really hope that is something now that payers will start to think about as important. the telephone visits have gone very well. but even there, again, a patient may experience inequity, because there are some patients who do not have a reliable phone or a secure private place to talk. this is particularly true as families are being forced to stay home. so still some patients are not able to talk as openly about their mental health needs and about stress they are facing if they cannot find privacy. for example, this is certainly relevant as we are seeing the increases in intimate partner violence some individuals are facing in their ''shelter-inplace'' housing situations. so, by moving all these things to telehealth, i think we have to be cognizant that some patients are not going to be able to access those things, and so in some ways, we are taking away barriers from people getting access to mental health care, but i also think we are also highlighting some increased barriers for some individuals. dr. charles mouton: yes. thank you. i think that some of the things that dr. kimmel has mentioned are also true in primary care. it looks like this health crisis is going to usher in a new way to approach health care and primary care, but i think in a lot of respects, these possible advancements leave behind some of the most vulnerable. with the covid- crisis, there have been closures of many primary care clinics, federally qualified health centers, and urgent care centers, with many of them switching to telemedicine visits. the issues highlight that many of the most needy do not have access to appropriate internet or computers to do any kind of video visits; this applies in the primary care setting as well. the inability to get adequately reimbursed for telehealth visits, with the requirement that it must be video captured, means that these telehealth visits may not get reimbursed. these are things that the centers for medicare & medicaid services (cms) is going to need to change if telehealth will move forward. the impact of the cms regulations on telehealth for some of the community providers that are not affiliated with large provider networks is even more profound; these are essentially private practices. so now you put them in a position where they do not have the necessary protective equipment to allow patients to come through their doors, they cannot see their patients face to face, and you force them to employ a new telehealth capability that they have to now get up and running. these limitations and loss of patient care revenue have many looking at closure of their practices. so now an already distressed underserved population becomes even more underserved and facing a real stressful time in terms of trying to get access to health care. in this access to care vacuum, you are seeing people trying to take care of themselves and family members with home remedies. we have heard about the unfortunate incidents with people using hydroxychloroquine inappropriately. we have instances of people, because of the misinformation that is being spread, using neosporin and other things. i think that people are becoming a little bit more desperate because they are unable to get the care that they feel that they need. on the opposite end of access to care is the issue, when they do wind up getting hospitalized, they then face problems with the distribution of the current health care resources. this reflects my concern about potential inequities that may arise when the decision has to be made about who gets a ventilator and who does not. we already know that implicit bias influences health care decision making. we have shown that over and over again. how does implicit bias influence a critical resource decision for people who are the most vulnerable? that question has yet to be explored and adequately addressed. i do not know of any effective strategies for eliminating implicit bias. and now we are faced with trying to come up with a strategy to deal with critical lifesaving decisions in stressed health care environments. will these biases have an untoward influence on not only access to care, but also people's general willingness to seek care? these are areas we need to have some attention paid, in particular, to alleviate. dr. furr-holden: i have been talking to a colleague who is a physician, and he said he had an ''aha moment.'' he is an anesthesiologist, so he is there when patients are being intubated, et cetera. and he said he watched a provider have a conversation with a family that said, ''this person has a zero percent chance of survival on a vent.'' so, you know, in essence, he talked the family into a ''do not resuscitate'' (dnr). there was really no medical foundation for that. so you talk about implicit bias, and it sounded a little bit like you were talking about bias on the side of the patients. what about bias on the side of providers? you know, we have been looking at and we have been experiencing these tremendous disparities. what we now know and are seeing is that it is not just the disparity of people dying on the vent, but also what is happening in the system of care where they are not even making it to the vent? how do you all think implicit bias is playing into the conversations that have no criteria for anybody else in the room? so some well-meaning provider potentially is steering black and brown and colored and other disparate populations toward dnrs. what do you think about that? dr. mouton: i think that implicit bias is, as they say, a real and present danger. i think providers are well meaning, but they are still making judgments. when thinking about people's ability to recover when they have comorbid conditions, it is important to bear in mind that those comorbid conditions are often a reflection of social inequities and society. and now, providers are having to tell these patients with certain comorbidities that when they need a health care resource, they may be ineligible. is that compounding the inequities that already exist? i think it is a difficult question. ethicists continue to debate the proper distribution of resources during times of scarcity. but, again, i am convinced that our own implicit biases influence how we make judgments and decisions. i worry that these biases will potentially lead to greater inequities as this crisis moves forward. more importantly, some of the policies and processes that are being put in place to deal with resource scarcity caused by the covid- crisis may wind up becoming the new standard that we turn to when making these kinds of decisions, so it is concerning. dr. carter-pokras: differential access and quality of care and implicit bias have been discussed in numerous reports over the past few decades, for example, with the task force report on black and minority health and the unequal treatment report from the institute of medicine. after taking into account health insurance coverage and other issues, you still see that difference in access to certain treatments when you look at many cardiovascular and other health conditions. the comment that dr. mouton just made is absolutely right. when it comes down to it during times of really tight constraints like what people are experiencing right now, decisions are indeed being made about who is going to receive care and who is not, and who is going to receive what could be considered lifesaving care and who is not. unfortunately, racial and ethnic minorities are more likely to have conditions that put them at greater risk for severe complications. right now, with covid- , underlying conditions that could prove to make outcomes worse could include diabetes, cardiovascular disease, hypertension, or asthma. we already know that racial and ethnic minorities have a disproportionate burden of illness and death. the ethicists certainly have their jobs cut out for them. even though this is the first major pandemic we have had since , it is not to say that we will not be dealing with another issue in the future wherein we are going to have to deal with major constraints and burdens to our existing health care facilities. the mental health of our providers is highly stressed and strained. important decisions are having to be made right now in almost a fight-or-flight mode, and those may tend to be even more likely wrought with implicit and unconscious bias. because there is already so much bias against mental health, that is just adding another layer of complexity. as much as people are saying that we understand how stressful this is, i do not know that people always still really do fully understand. i just read an article on a website about finding a therapist during this time, and it tries to give a number of resources no matter your insurance or need. however, our system is still very much biased against those needing mental health support and set up for self-pay. although telehealth opens new avenues, it still is going to be more accessible for those who can afford to pay a therapist online through numerous services popping up to take advantage. those who cannot afford these services will still have to deal with the same biases such as mental health care not always as covered as other health care needs. we are all bringing bias about what is needed and how to use resources appropriately. we have talked a bit about telehealth and telemedicine. what do you think are some of the best practices that you think are being underutilized, and what do you see as really the stopgaps or policies that we need to implement as a part of the standard of care? dr. mouton: there is a major economic gap within the health care sector. inner city and rural provider practice differ substantially in the financial resources they have available to reinvest in new practice technologies. i think that as we try to use technology to provide access to health care, without policy guidance and financial support, particularly from cms, there will be a number of obstacles. if telehealth is here to stay, which most people say it is, then coupled with the expansion in digital health care monitoring, such as using the internet of things in people's homes to support better monitoring, we can start to see an intensification of the inequities for the communities served by these practices. what does that mean for someone who has no internet and no things? so, you talk about the internet of things, but many of our patients who are disadvantaged in terms of access and health care provision also lack those tools and devices. more and more, health care is going to move in that direction, and unless the funders of health care decide this is of big enough value to distribute to those who no longer can afford it or do not have it, to allow them to reap the benefits of this, we will again create a broader and deeper gap in terms of what people are able to receive and benefit from. so, to me, that is something that, if we would address, would go a long way to bridging that gap. but it is going to take an investment to make that leap forward. dr. carter-pokras: one of the things that has been brought to bear is that people are recognizing now how good or how poor their internet access is in a way that i do not think they really fully understood previously. we are understanding that in under-resourced communities where children have been expected to continue their schooling at home, they are unable to continue their online studying because they do not have enough bandwidth, even if they do have a computer. , schools have been making computers available to the children who do not have computers at home, but you have to stand in line within a certain period of time to go pick up the computers, and even then there may not be enough computers. and those who do finally get their hands on a computer are not given the online homework that they were supposed to have been given, or their parents cannot help them, whether it is because of language issues or other issues. so, in addition to universal health care, universal access to the internet is something that we can put on our wish list. on top of everything else, some people have been asked to vacate their housing. , can you imagine? forget about access to the internet, right? they have been asked to vacate their housing. they do not have a way to pay for their housing because they lost their job, and they have been asked to vacate their housing. we are also seeing an increase in domestic violence and calls to mental health lines with people experiencing desperation, anxiety attacks, suicidal tendencies, et cetera, because of this. so universal health care and universal access to the internet are two things we definitely want to think about. in the meanwhile, we cannot have everything available only online. it has to be available in other ways that people can access because not everybody has access to the internet right now. it is interesting that you mention these points, like the mental health concerns and people being evicted, because again, we are thinking about, what are the policies to support some of these things? as an example, michigan has issued a stay on all evictions, so people are not actually allowed to be evicted during this period. now, i think about homeowners who maybe moved and are renting out their house but are dependent on that rental income to pay their mortgage. well, their mortgage is still coming due, so all these pieces are connected. if you think about it from a policy perspective, i love when you say not just universal health care, but also universal access to the internet, especially if we are talking about telehealth and telemedicine and some of these other things. if we can identify the gaps, if we can see the problems, then how should we respond in terms of policy? what happened in michigan is then they started adding to the stay of eviction order to prevent people from being evicted, because, of course, housing is so essential, if the whole order is to stay put to stay safe. but then they started to put resources in place for noncommercial owners of homes who are providing housing so that they are also solvent during this time. sometimes the one policy creates another problem that is just one step down the road. we need to be asking what these comprehensive policies are that will actually get us somewhere and create solutions, not displace or move the problems one tick down the road. dr. kimmel: along those lines, i have talked to some pregnant women who already had housing instability before all this, and they had been saving up to get more stable housing of their own before the baby comes. but now they cannot go out and must continue to make difficult cramped housing situations continue to work. many services individuals may have once accessed at a physical office, such as working with someone to get a housing voucher, cannot be done during this time when so many things have to remain closed. online is now sometimes the only way to access things. we need internet, better internet, but we also need better and more case management and services to help people navigate, because the system was always really fractured, but i feel like now it is even more unclear who can help and who cannot. when we are all allowed to go back to work, there are still going to be these downstream effects of when a person did not find housing at the critical time before the baby came. dr. furr-holden: i have what i call a ''man-onthe-moon'' idea. what i mean by that is, when they said ''man on the moon,'' that just seemed like it was purely aspirational and almost impossible to achieve at the time, but despite that, it was well resourced, and it happened. what do you see as the kind of the man on the moon? where should we really be setting our sights if we are actually and truly going to deal with inequity in access to care? dr. mouton: i think because of the covid- crisis, we now have a renewed focus on the need for an adequate public health infrastructure. i would like to see us set up a framework of a solid adequately funded public health and preventative care infrastructure that assures a baseline of health care access across all populations and all classes. we couple that with key access provisions for communities across this country, both rural and urban, that gives access both to ''brick and mortar'' clinical practices as needed plus access to primary care, either by telehealth or in-person, which assures that these communities are able to maintain an adequate level of health that, in turn, allows the members of the community to enter the workforce, maintain income, and maintain social stability. that would be my moon shot. dr. carter-pokras: i already talked about my wish for universal health care, but i would also stretch that to not having access to health care be tied to our workplaces because there are so many people who lost their jobs as a direct result of covid- , and that also means they lost their health insurance. health in all policies, also, i think that is really important. health is created by a number of factors that go well beyond the scope of health care and public health activities. we gave the example about what happens when somebody gets evicted during this pandemic and the need for housing interventions at this time. i also think we need to have better appreciation for essential workers who have previously gone unnoticed. there are so many people who are keeping us going, whether it means our water coming through in our tap, or somebody picking up our garbage, or the people who are stocking the shelves at the grocery store, and hopefully providing them with the benefits that they need going forward. we could also benefit from having a better understanding of our supply chain, especially the food chain, and what we need to do to protect and maintain that. dr. furr-holden: i love that universal health care not being tied to work has been mentioned, and universal access to the internet. dr. carter-pokras: and also, protecting our supply chain, especially our food chain, and protecting those who are essential employees, including those who up to this point many people did not even really see them. they were almost invisible in a sense. dr. kimmel: all of these things are in line with what i would love to see. i think really trying to get people care in a way that meets their needs and is more individualized and personalized is a priority. for some people, that is going to mean being able to use the telephone to access care. for some people, that is going to mean that their internet access should be improved. then for some, these improvements still are not going to be the answer, so how can we also have safe places patients can go and use the internet to do an appointment or that someone comes to them and takes them to a safe place? to have this kind of individualized support will require thinking about how to expand our workforce for mental health support and use our workforce more effectively to ensure patients have time with supports and also those supports have time to personalize their approaches to the resources of each patient. this does not necessarily apply only health practitioners but also peer supporters and other community members who can be there to support mental health needs. i grew up in a more rural region and now many of the patients i care for are from rural areas. we have so many rural families in north carolina who have to drive hours to get to care. is there a way that we can have someone who can go out to them and do a visit, who can bring the ipad to access their specialist? can a psychiatrist provide supervision to a care manager who can go out to them and do that visit? dr. carter-pokras: thank you, dr. kimmel, for bringing that up, because our previous surgeon general, dr. vivek murthy, has really felt that loneliness is a crisis, an epidemic in our country. he is working on trying to get more information out about this crisis. i went through a -month training for a certificate in positive psychology and i am also a resilience trainer. it seems people are really desperate for finding ways to strengthen resilience skills now more than ever. in today's digital world, resilience is something that we would lift everybody's boats and help them identify how they can strengthen those social connections going forward. and i just want to let you know, in addition to all of the other issues that i had mentioned earlier for my wish list, i would also add that language interpretation, improving transportation, and improving the ability to pay for care are also important. all of these things still need to be addressed in terms of improving access to care and quality of care. dr. furr-hoden: dr. kimmel, you said something about expanding and increasing the health care workforce. i would be curious to hear your thoughts about how the public health infrastructure was not prepared to meet the demands of the covid- pandemic. what are the immediate needs you see? dr. kimmel: i think right now, so much of the focus is understandably on the immediate needs because so many people are getting seriously ill. and on top of that many health care workers are becoming ill and not able to come into work. with so much immediate need, we are focusing on the immediate needs and realizing the workforce does not have as much plasticity as we need. but then even as covid- cases slow and people are not getting so ill from the coronavirus, we are going to be left with large mental health needs. we will need to focus on building the workforce to cover those areas, too. we need to be building a workforce that can also help communities develop their resilience and help people build resilience. part of managing trauma is helping people realize how their stories are important, and what they have been through is important. this can help them see the strength that they have gotten from their experience. so we need that kind of workforce, as well, to build resilience. building that kind of resilience requires time for people to sit down with people and talk, and it is hard to do that in a -min visit. how do you build a workforce wherein the work does not have to be done in that short of a visit? how do we have other people who can also fill that role? when i think about the workforce, i have kind of a contrarian view, particularly when you talk about the physician workforce. if we talk about the physician workforce, i think the issue substantially is a maldistribution problem more than an adequate numbers problem. and again, that is driven by economic factors and reimbursement issues rather than, i would argue, individual physician desires and practice hopes. i see economic factors related to where physicians choose to practice as a major driver. now, if we look at the health care workforce at large, i think we still have needs for many health professions in the context of covid- , particularly from nursing and respiratory therapy, to meet this acute need. but i even wonder sometimes about that, because when you look at what is happening to the hospitals, due to the covid- -related economic forces, many of them are laying off nurses and looking at a future wherein there will be far fewer of these health care workers. so, to me, it begs the question, if we have a true health care workforce shortage, why would economics be the sole driver in the decision to lay off a substantial workforce, because you still would need them to run your enterprise? so, again, i wonder how much of this is driven by a distribution issue, and where people are being deployed, and where they are being located, as opposed to an absolute numbers issue. and it may be both. if it is a distribution issue, how do we solve that problem? how do we build the kind of incentives so we can have people where the needs are versus where the resources are? dr. mouton: well, right now the issue is that incentives are driven by the economic forces. as you move the economic forces out of the industry and say that we will deploy people where the need is the greatest, and they will be paid substantially the same or with some increased benefit for taking on those assignments, then that would be different. now, i am not saying that a universal one-payer health care system will necessarily do that, but it might. i have to study the distribution issues in canada and in england to see how their systems work, but i think they are better prepared. people may argue about whether or not that is true. i think part of our issue is that economic factors drive where physicians live, practice, what specialty they choose, and what geographic area they live in. and without economics being the main motivating factor, figuring out how to distribute the health care workforce in a manner that takes that away, you could have a situation wherein people will choose to work in environments that give them better economic fulfillment. dr. furr-holden: fantastic. this was an important conversation and i am glad you were all able to join me. thank you all for participating, and for sharing your thoughts about what impacts equitable access to health care in the united states. latino health steering committee improving health insurance coverage for latino children: a review of barriers, challenges and state strategies healthcare disparities and models for change role of acculturation research in advancing science and practice in reducing health care disparities among latinos available at www.pewhispanic.org/states/state/ md/ accessed table r : median household income american community survey year estimate emergency preparedness: knowledge and perceptions of latin american immigrants immigrant workers: vital to the u.s. covid- response, disproportionately vulnerable call for more resources in spanish in montgomery. activists warn latinos in county need more information and help what do health literacy and cultural competence have in common? calling for a collaborative health professional pedagogy verify: rubbing antibiotic cream in your nostrils won't prevent coronavirus. wusa . fair allocation of scarce medical resources in the time of covid- available at https:// collections.nlm.nih.gov/catalog/nlm:nlmuid- -mvset accessed us) committee on understanding and eliminating racial and ethnic disparities in health care centers for disease control and prevention. covid- in racial and ethnic minority groups how to find a therapist during the covid- pandemic coronavirus lockdown, lack of broadband could lead to 'education breakdown educators tell van hollen: digital divide doesn't just impact distance learning. maryland matters landlords are illegally evicting tenants during the coronavirus pandemic. lawyers fear a 'tsunami' of evictions when state moratoriums end council freezes rent hikes but omits undocumented immigrants from covid- relief bill. the washington post domestic violence cases surge amid stay-at-home orders. the hill americans increasingly reaching out for mental health help during coronavirus pandemic centers for disease control and prevention. health in all policies association of state and territorial health officials. covid- intervention actions: supporting individuals experiencing homelessness publish in health equity -immediate, unrestricted online access -rigorous peer review -compliance with open access mandates -authors retain copyright key: cord- -w g s ro authors: ribeiro, nadine; mota-filipe, helder; guerreiro, mara p.; costa., filipa a. title: primary health care policy and vision for community pharmacy and pharmacists in portugal date: - - journal: pharm pract (granada) doi: . /pharmpract. . . sha: doc_id: cord_uid: w g s ro the central role of the portuguese national health service (p-nhs) guarantees virtually free universal coverage. key policy papers, such as the national health plan and the national plan for patient safety have implications for pharmacists, including an engagement in medicines reconciliation. these primary health care reform, while not explicitly contemplating a role for pharmacists, offer opportunities for the involvement of primary care pharmacists in medicines management. primary care pharmacists, who as employees of the p-nhs work closely with an interdisciplinary team, have launched a pilot service to manage polypharmacy in people living with multimorbidities, involving potential referral to community pharmacy. full integration of community pharmacy into primary health care is challenging due to their nature as private providers, which implies the need for the recognition that public and private health sectors are mutually complementary and may maximize universal health coverage. the scope of practice of community pharmacies has been shifting to service provision, currently supported by law and in some cases, including the needle and syringe exchange program and generic substitution, remunerated. key changes envisaged for the future of pharmacists and their integration in primary care comprise the development and establishment of clinical pharmacy as a specialization area, peer clinician recognition and better integration in primary care teams, including full access to clinical records. these key changes would enable pharmacists to apply their competence in medicines optimization for improved patient outcomes. the gross domestic product (gdp) per capita for was , usd, with slight increases in the last years, albeit with some exceptions during recession years. , the portuguese health care system is well structured, as a result of the creation of a portuguese national health service (p-nhs) in , offering universal health coverage. the p-nhs follows a beveridge model, where health care is funded by the government through tax payment. in the government's expenditure on health was % of the gdp with an out-of-pocket expenditure by citizens estimated at . % of gdp. in , around a third of portuguese citizens have private health insurance, not because of ineligibility for p-nhs care, but mostly because of a perception of low quality of the public system or delays in access to specific treatments (e.g. surgery). the health care workforce has been increasing, with . physicians, . nurses and . pharmacists per , inhabitants in . the dominant feature of the health program presented by the government for the period - lies in the introduction of new forms of services provision and organizational structures with objective to better respond to societal needs and improve the efficiency and quality of care. , these forms of delivery intend to promote innovation and disruption of traditional approaches, improving access to health services, whilst maximizing integration of local responses between different levels of care to achieve continuity of care. public participation emerges as a fundamental axis of the p-nhs reform, aligning its services with citizens' expectations and needs, both in hospitals and in primary health care. special emphasis is given to activities and services that may contribute to promote healthy ageing. these comprise alternative ways of service provision, resorting to digital technologies, creating it systems for data management and data consolidation. finally, the government program also addresses current challenges in achieving universal health coverage without the risk of financial hardship, by reinforcing the government's responsibility of ensuring health for all and subjecting third party contracting for p-nhs services to a needs and capacity assessment. international series: integration of community pharmacy in primary health care primary health care policy and vision for community pharmacy and pharmacists in portugal the main strategic lines of the national health policy reported by the portuguese general health directorate are brought together in the "national health plan", based on four strategic axes: . public participation in health, reinforcing the citizen's power and responsibility towards individual and collective health; . equity and adequate access to health care; . health quality, where emphasis is given to personcentered care and value-based outcomes; . health in all policies. the national health plan sets specific goals to be met in , some of which highlight the role of patient healthrelated behaviors in achieving optimal health outcomes (e.g. to reduce the prevalence of smoking behaviors in population aged over ); and identifies challenges that must be overcome to meet the set targets. none of the goals are specifically directed to pharmacists, although several challenges are specifically relevant for primary care, and by implication for pharmacists and pharmacies. one of the strategies refers to providing person-centered care instead of disease-focused care; the latter resulted in fragmented care arising from uncoordinated specialists treating multimorbidity. worth noting is the challenge of information technologies for timely and coordinated access to clinical data for all professionals, so that patient safety is guaranteed. another key policy paper is the national plan for patient safety - . strategic goal # aims at increasing medication safety. one of the actions under this goal is the provision of medication reconciliation; with an implementation goal of % of all p-nhs units by the end of . the quality and safety commissions of hospitals and primary health care units have the responsibility for the implementation of the national plan for patient safety. this commission includes the participation of publicly employed primary care pharmacists. primary health care is considered as the basis for achieving universal health coverage and optimal care outcomes. this view has been endorsed by the current government but also by former administrations. the portuguese primary health care reform in was characterized by the organization of health care centers into larger administrative units, designated health centre groups, and the creation of family health units. , health centre groups are under the direct responsibility of regional health administrations (arss). there are five of these regional branches of the p-nhs in mainland portugal, with the mission of guaranteeing population access to health care, adapting available resources to local needs, complying with and enforcing health policies and programs in their areas of jurisdiction. a significant feature of the primary health care reform is to expand and give greater autonomy to family health units; this is expected to leverage local responses by creating more community care units and strengthening the links between primary health care, long-term care and palliative care. another policy priority is providing primary care with additional multidisciplinary specialties and to encourage the adoption of new workflow models. family nurses are an example of these new specialties. integration of clinical psychologists and nutritionists in primary health care units has also been announced. to date, there is no mention of pharmacists and their role in this setting or their inclusion in family health units. however, the multidisciplinary approach may be an enabler for including additional health care professionals, who can add value to care provision. in fact, the portuguese family health units national association (usf-an) has advocated for greater skill-mix, through the incorporation of primary care pharmacists with advanced competencies in clinical pharmacy into these multidisciplinary teams. currently, the regulatory body of the pharmacy profession in portugal, the portuguese pharmaceutical society, does not endorse clinical pharmacy as a specialty. in theory both hospital and community pharmacists may qualify as clinical pharmacists, depending on their level of practice, and be subjected to standards that remain to be defined. staff pharmacists from the arss, who have a hospital background, have occasionally taken up this role in primary care units. these primary care pharmacists represent a limited pharmacy workforce for clinical services as they are only for the entire country. they are public servants and their main roles are managing medicines procurement (all % engage in these activities), public health activities (including provision of scientific and technical counselling at an ars level, involvement in policy recommendations, drug use studies, monitoring indicators for contracted services; around % engage in such activities) and clinical pharmacy (including prescription validation and medicines reconciliation; around % engage in these activities). although no specific mention is made to the role of pharmacists in primary health care in existing health policies papers, many strategic goals for this setting include activities where pharmacists' training is an asset for the multidisciplinary team and, more importantly, for people living with illness. an example is the "pharmacotherapy prescription qualification" strategy, aiming to reduce costs whilst achieving maximum benefits for people using medicines. this strategy relies on recommendations issued by pharmacy and therapeutics committees in primary health care, underpinned by scientific evidence. primary care physicians and pharmacists are, by law, members of these committees, and exemplify a bottom-up approach to change addressing unmet needs of clinical practice. to address population ageing and the absence of structured programs to manage polypharmacy in primary care, a pilot service was designed and implemented in two arss by an interdisciplinary team involving primary care pharmacists, general practitioners (gps) and nurses. this service targets chronic, complex and fragile people over years old and entails a structured initial face-to-face medication review performed by the primary care pharmacist in patients referred by the gp, followed by a discussion about opportunities for medicines optimization and a follow-up, based on an agreed plan, with safety and effectiveness indicators for medicines and other pertinent strategies, such as education, lifestyle counselling and medication adherence enabling interventions. where appropriate, usually in the less complex cases and subjected to patient's agreement, community pharmacies are contacted to ensure continuity of care. this collaborative model is new and has so far, no remuneration. in this novel service primary care pharmacists have access to medical records and can discuss the case with patient's care team. the service is currently available in three primary care units, and the expansion to the remaining units depends on workforce availability. it represents an opportunity to foster the integration of community pharmacies in primary health care. even though the inclusion of a primary care pharmacist in primary care units is currently centered in the management of polypharmacy, it may encourage involvement in other activities, including physician and nurse education on new therapies. this service may be considered disruptive in the portuguese context, since multidisciplinary teams in this area are new. such programs fit into the major changes planned and designed by policy makers in the scope of primary care provision. there were , registered pharmacists in portugal in , % of whom practice in community pharmacy, % in hospital pharmacy and the remainder distributed through other areas of pharmaceutical sciences. in , according to the fip, there were, . registered pharmacists per , inhabitants, quite high in relative terms to other countries. the number of pharmacists has progressively been growing in portugal, aligned with international projected trends. interestingly the pharmacists in portugal are young, with % below years of age and % aged between and years. in , the , community pharmacies were distributed throughout the country. ownership rules and geographical distribution changed in with legislation that terminated the exclusivity of pharmacy ownership by pharmacists. community pharmacies may be owned by non-pharmacists, but each pharmacy must have a pharmacist technical director responsible for the functioning of the pharmacy and compliance with good pharmacy practice. the ownership of a pharmacy is, however, restricted to individuals or corporations that have a conflict of interests in medicines dispensing, such as wholesalers, pharmaceutical industry, associations representing pharmacies, prescribers, private entities providing health care and p-nhs subsystems that co-pay for medicines. the legislation also states that for a new pharmacy to be opened, there must be a minimum of inhabitants in the location, unless the pharmacy is opened at a distance of more than km from the closest pharmacy or, within residential areas, meters between pharmacies in a direct line; meters between the pharmacy and the health care unit, except in places with less than , inhabitants. there are two associations representing the interests of community pharmacy owners in portugal, the national membership is voluntary for both associations. anf represents % of pharmacies in portugal and has the mission "to make pharmacies the most valued primary health-care network by portuguese citizens". to achieve this goal, anf has developed companies, structures and projects which cover areas relevant to pharmacies, in political, professional (education and pharmaceutical services), and financial areas. one of the main activities for both organizations is the relationship and advocacy with government and health administration, in order to ensure that pharmaceutical legislation and regulation, as well as operationalization, take into account the actual and potential added-value community pharmacies can bring to the health of the population. the plan of activities of anf for identifies as key intervention areas for investment: the development of new services that meet the healthneeds of the portuguese population; perusal of the pilot to dispense hiv medication in community pharmacies and investment in developing methodologies for extending to oncology; supporting pharmacies in the implementation of point of care services for hiv and viral hepatitis; implementation of a service to respond to minor health problems, including physician referral when appropriate; promote remuneration of pharmaceutical intervention; developing clinical pathways integrated into a clinical support system for pharmacies. pharmacies in portugal may sell medicines for human use, medical devices, veterinary medicines, homeopathic medicines, herbal products, medical devices, nutraceutics, cosmetics, products for childcare, products of comfort and food supplements. in addition, the legislation foresees the services that may be provided in pharmacies by qualified pharmacists and other allied health care professionals (table ) . , community pharmacies' revenue come mostly from a mark-up margin on the price of medicines dispensed. in the case of prescription medicines, the remuneration system is set by the government. major changes were implemented in and further adjusted in . the system combines a regressive mark-up based on a percentage of the medicine ex-factory price (from . to . %) and a progressive dispensing fee per package (from . eur to . eur). for most non-prescription medicines and medical devices, as well as other products available in the pharmacy, the selling price is freely established by each pharmacy and remuneration is a percentage mark-up, on average estimated to be around %. in terms of service remuneration, the system is quite different, and these are, in general, charged using retrospective or prospective analysis. retrospective methods are the most commonly used in the outpatient setting and include for example the fee-for-service, whereas prospective methods tend to be adopted in the hospital setting and an example is a coding system for diagnostics and associated procedures entitled the homogeneous diagnostic groups. in portugal, the two community pharmacy services remunerated use fee for service, established nationally by the government by law and regardless of clinical outcomes for the patients. in , legislation was passed for contracting public health services to community pharmacies. interventions aligned with health policy priorities, such as programs integrated in primary care, needle and syringe exchange program and medication adherence interventions are mentioned in this regulation. one of the two services currently remunerated is the needle and syringe exchange program available in community pharmacies since . this internationally acclaimed program for its contribution to minimize hiv and other blood-borne diseases was initially delivered pro bono by pharmacies. program evaluation indicated that pharmacies' contribution resulted in a net benefit of . eur per needle exchanged, originating overall system savings of over million euros in a -year period. the reimbursement system reflected these data, pricing at . eur each package of needles exchanged. this program is closely monitored and the most recent data available shows a % increase in the number of needles exchange in pharmacies between january and june , compared to january to june , corresponding to a monthly average of , needles, totaling , in the period considered. the other remunerated service is generic substitution, which aims to the increase of generic market share. legislation to reward generic substitution and incentivize dispensing the least costly options has been active since and the most recent update refers to . eur/package. the market share of generics for was . % in units or . % if measured in defined daily doses. this corresponds to an increase near percentual points since . despite legal coverage, no other services were contracted to date. other services (table ) are freely priced by pharmacies and paid out-of-pocket by users. the price of these services vary widely (including services delivered for free) and there is no publicly available data on number of services or pricing. nevertheless, it is compulsory by law that all pharmacies display in a public area (physical space and website) the full list of services available and price charged for each service. as an example, the administration of vaccines in pharmacy may be charged between and eur. the ministry of health has promoted a reinforced public health role for community pharmacies, namely by enabling certified community pharmacists to dispense hiv medication, previously dispensed exclusively in hospital, in a pilot program and to reinforce the responsible use of these medicines in stable patients, working in articulation with p-nhs hospitals. the pilot is ongoing in one region, and depending on success, is foreseen to be broadened to also cover oncology medication. currently, the regulatory agency has a system in place to monitor the effectiveness and safety of health technologies. this system is mainly focused on high-cost medicines, i.e., oncology, orphan drugs, antivirals, etc., and relies mostly on hospital-based data sources, or on population-based registries when available. however, considering a potential shift of some of these medicines to the community pharmacy, the intention to also resort to the pharmacies' information system for health technology assessment has been announced. félix et al. have estimated that community pharmacy services in portugal provide a quality of life gain for citizens of . %, resulting in savings for the p-nhs and general population over million eur. services valued by citizens, include the immunization service, point of care testing and medication review, to name a few. [ ] [ ] [ ] in fact, there are a number of services paid out-of-pocket, e.g. point of care testing (blood pressure, glycaemia, cholesterol, etc.), totaling more than different services (table ) . recently, the government started a pilot program providing influenza immunization in community pharmacies. people aged over years could have their vaccine administered in a healthcare center or in a community pharmacy at no cost and with no prescription order required. during winter season, , individuals from the municipality of loures preferred their community pharmacy to the healthcare center. this suggests the potential benefit of providing access through community pharmacy however it cannot yet be determined if the target to increase vaccination coverage was achieved. the implementation of technology in community pharmacy practice has been growing, including using robots to aid in dispensing to maximize workforce, and using algorithmbased programs to support identification of medication errors. electronic prescribing has become fully implemented in portugal in , through which people no longer need to resort to paper prescriptions and shows that technology barriers and information access may be overcome. full use of technology is likely to contribute to further development of advanced services in the best interest of people living with illness, if pharmacists and table . community pharmacy services established by law. ,  home support  first aid  administration of medicines  use of diagnostic and therapeutic auxiliary means  administration of vaccines not included in the national vaccination plan  pharmaceutical care programs  nutrition appointments  adherence programs, medicines reconciliation, services making use of multicompartment aids, health education programs for the use of medical devices  point of care testing for the screening of hcv, hbc and hiv, including counselling pre and post-test and referral of positive cases to hospital care following referral channels established by the ministry of health  nursing services, including wound treatment and care of people with ostomies  level i care to diabetic foot, according to the recommendations of the department of health  promotion of campaigns for health literacy, disease prevention and healthy lifestyle promotion. representative associations see it as an opportunity and not as a threat. one of the main challenges for community pharmacies to become integrated in the p-nhs is their private ownership. a paradigm change by government is required, to regard private providers as a supplementary or complementary source of health care, similarly to what occurs with privately managed hospitals. another key challenge is to achieve full data integration, so that community pharmacists may have access to patients' data and can contribute to updated information by registering their interventions. this is an important prerequisite to some of the services mentioned such as medicines reconciliation. it is also important for national public health information particularly in the context of vaccination coverage, for which some pilot experiences are already in place, that vaccine administered in the pharmacy are registered in the online health bulletin. these pilot experiences show that the access of data is more a matter of political will then a technical issue. crisis may lead to opportunities and the current covid- pandemic is a good example of how pharmacies can contribute to the seamless supply of medicines. there were two main measures, supported by legislative changes that created the possibility for community pharmacies to deliver hospital-only medicines for extended periods (including antiretrovirals, immunotherapy, etc); and the possibility for renewal of chronic medication in community pharmacies. , both measures were created and implemented in order to provide access overcoming existing barriers and recognizing competences of professionals involved. such measures became possible in troubled times, which shows that when there is an urgent need, barriers may be overcome. epidemiological trends in portugal clearly show there is an ageing population with a growing prevalence of noncommunicable diseases. societies are also growingly more technological and more empowered. services should be redesigned to serve societal needs and not to foster professional interests. pharmacists may have an enormous contribution to meet sustainable development goals (sdg), particularly in ensuring healthy lives and promoting wellbeing at all stages (sdg # ) as well as promoting a more effective use of limited resources. there are missed opportunities, including for instance, engagement in exercise and health promotion through liaising with local communities, schools or residential facilities. there are also unmet needs in primary care services in marginalized groups, including those living in prisons, the homeless and migrants, where pharmacists could make a difference working collaboratively. there are activities being implemented in community pharmacy solely for commercial reasons, even if there is no real need or gaps in service provision, including optometry, audiology and other services. pharmacists have no competence in this areas and merely make their space available to external providers. clearly one area for continued and reinforced investment will be the establishment of clinical pharmacy as a competence or as a specialization area, which can support medicines optimization across the entire patient pathway, from community, to primary care, to hospital and ultimately to specialized care. filipa alves da costa declares to have an advisory role for the portuguese pharmaceutical society. the other authors declare no conflict of interests. none. lisboa: fundação francisco manuel dos santos uma perspectiva sobre o relatório da ocde "health at a glance country statistical profile: portugal costs with health care as a percentage of gdp 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programme in pharmacies say no to a second-hand needle regulates remuneration to pharmacies by dispensing reimbursed medication as a function of the reduction of reference pricing acesso a cuidados de saúde nos estabelecimentos do sns e entidades convencionadas. relatório anual. lisboa: ministério da saúde using cancer registries to supplement clinical trial data and inform regulatory decision social and economic value of portuguese community pharmacies in health care an overview of current pharmacy impact on immunisation: a global report. the hague; fip primary health care policy and vision for community pharmacy and pharmacists in portugal community pharmacist-led medication review procedures across europe: characterization, implementation and remuneration a survey to assess the availability, implementation rate and remuneration of pharmacist-led cognitive services throughout the pharmacists' guide to the future: are we there yet? / : fourth modiffication of the portaria n.º / , legal regime for the prescription and dispensing of medicines and health-related products development of a complex intervention to improve adherence to antidiabetic medication in older people using an anthropomorphic virtual assistant software pharmacists reinventing their roles to effectively respond to covid- : a global report from the international pharmacists for anticoagulation care taskforce (ipact) guidance on proximity access to hospital only medication in the context of covid- pandemic issued / / : exceptional and temporary measures for electronic prescribing of medicines during covid- pandemic transforming our world: the agenda for sustainable development benzodiazepine dose reduction in prisoner patients: years' teamwork between psychiatrists and pharmacists key: cord- - td a authors: lazcano-ponce, eduardo; allen, betania; gonzález, carlos conde title: the contribution of international agencies to the control of communicable diseases date: - - journal: arch med res doi: . /j.arcmed. . . sha: doc_id: cord_uid: td a although inequality is often measured through three critical indicators—education, income and life expectancy—health-related differences are also essential elements for explaining levels of equality or inequality in modern societies. investment and investigation in health also involve inequalities at the global level, and this includes insufficient north-south transfer of funds, technology and expertise in the health field, including the specific area of communicable diseases. globally, epidemics and outbreaks in any geographic region can represent international public health emergencies, and this type of threat requires a global response. therefore, given the need to strengthen the global capacity for dealing with threats of infectious diseases, a framework is needed for collaboration on alerting the world to epidemics and responding to public health emergencies. this is necessary to guarantee a high level of security against the dissemination of communicable diseases in an ever more globalized world. in response to these needs, international health agencies have put a number of strategies into practice in order to contribute to the control of communicable diseases in poor countries. the principle strategies include: ) implementation of mechanisms for international epidemiologic surveillance; ) use of international law to support the control of communicable diseases; ) international cooperation on health matters; ) strategies to strengthen primary care services and health systems in general; ) promotion of the transfer of resources for research and development from the north to the south. many obstacles to the improvement of global health persist in the st century, something that is evident in the large degree of health-related inequality between rich and poor countries. infectious diseases constitute the second cause of death worldwide, are an incalculable source of human suffering and cause immense economic loss at every level. in point of fact, % of all deaths worldwide and % of the global burden of disease can be attributed to infectious diseases ( figure ). unfortunately, not only are the majority of these deaths potentially preventable, but over % occur in developing countries, where poverty is often the common denominator. the three infectious diseases that cause the largest number of deaths are hiv/aids, tuberculosis and malaria. against this background, the need to achieve a greater degree of social justice and uphold the human rights of the populations of poor countries is the principle justification of north-south assistance related to emerging and re-emerging infectious diseases ( ) . in this context, there are a number of strategies that international health agencies have used in order to contribute to the control of communicable diseases in poor countries. this essay reviews these efforts, beginning with the mechanisms created to facilitate international epidemiologic surveillance. the use of international health law as a tool for global collaboration on the control of communicable diseases is also touched upon. next, international cooperation on a range of health matters and efforts to strengthen primary health care and health systems in general in poor countries are referred to. finally, a discussion is included about how international agencies facilitate the north-south transfer of resources for research and development and contribute to the implementation of these investments in the areas of research, surveillance systems and improvements to health. diseases that are rapidly spread, including a number of emerging and re-emerging infectious diseases, require surveillance systems with a high degree of sensitivity, which are also opportune. surveillance systems with these characteristics allow rapid decision making and action to stop an outbreak from growing or to control an epidemic. given the above, a new paradigm for global collaboration has been developed based on the establishment of surveillance networks at the international level. epidemics and outbreaks in local regions can represent an international public health emergency. although such situations require a global response, there is no single institution with the ability to guarantee health safety worldwide. therefore, collaboration by international agencies, national governments and individuals with pertinent expertise is required. collaboration in this area has included the establishment of the networks for surveillance of emerging infectious diseases, three regional structures operating in latin america with the support of the pan american health organization (paho) ( ) . these networks carry out epidemiologic and laboratory-based surveillance of emerg-ing and re-emerging infectious diseases in the amazon, central american and the southern cone regions and provide a forum for information exchange, cooperation on capacity building and collaboration on quality control mechanisms, all aimed at the prevention or control of epidemics ( ). another initiative in this area is the global outbreak alert and response network (goarn), which was established in under the guidance of the world health organization (who). goarn provides a technical, multidisciplinary response to outbreaks and epidemics with a global outlook. this network aims to improve coordination of international responses to situations involving emerging and re-emerging infectious disease by focusing its actions on technical and operational support for national or regional efforts. goarn assists countries in actions targeted at disease control by ensuring rapid technical support; investigation and risk calculation in epidemics; controlling outbreaks of diseases with the potential for spreading rapidly; providing technical advice and guidance; carrying out epidemiologic research; advising on clinical management issues; confirming laboratory diagnoses; handling dangerous pathogens; and giving logistic support and sending supplies (drugs, vaccines, reagents, medical equipment). goarn constitutes a global resource that guarantees rapid access to experts and necessary operational resources for infectious disease control (see box ) ( ). traditionally, international law has been a central tool in the global surveillance of communicable disease. throughout the th century, international law was decisive for coordinating quarantines in different european countries, which were not coherent from one nation to the next. international legislation and norms have contributed to the exchange of epidemiologic information about infectious diseases in diverse geographic areas, justification of the establishment of international health organizations, and support for epidemiologic surveillance systems for communicable diseases. as the world enters the st century, communicable diseases continue to stretch the limits of global health policy, carried out through the use of legally binding instruments and voluntary norms. such legislation is discussed and adopted within the framework of multilateral institutions such as the who, world trade organization (wto), food and agriculture organization of the united nations (fao) and the world organization for animal health (oie). international law has constituted an indispensable tool for the protection and promotion of health in the context of globalization. international legislation has also been useful in the application of global health policy aimed at reducing human vulnerability to mortality and morbidity due to communicable diseases ( ) . the international health regulation, and particularly global regulations related to the control of infectious disease, have not been significantly modified since its proposal in . therefore, the who and paho have been involved in coordinating the review and modification of the international health regulation, which constitutes a series of guidelines for cooperation by countries on the control of disease outbreaks ( ) . the recognition of the need for changes in the international health regulation grew out of the emergence of new infectious diseases such as severe acute respiratory syndrome (sars, see box ), ( ) as well as the resurgence of re-emerging infectious diseases which for the latin american region include cholera ( ) and typhoid fever ( ) , while in africa reemerging diseases that indicate the need for this modernization of health regulations include influenza, ( ) measles ( ) and cholera ( ) as well ( figure ). the efforts to modify the international health regulation proceed from an understanding of the issues raised by increasing globalization; specifically, public health emergencies with international repercussions. important in this respect is the need to take into account the potential for the international spread of an emerging or re-emerging disease while also measuring the repercussions for the free circulation of people and goods ( ) . the who proposal for modernization of the international health regulation includes the following: ) a mission with a stronger focus on control of infectious diseases, ) emphasis on broader health care coverage and better access to treatment schemes, ) global surveillance including data from official and non-official sources, ) strengthening of national public health systems through the establishment of comparable productivity indicators and outcome measurements, ) giving priority to the protection of human rights, ) guidelines for good health governance defined as adoption of the principles of impartiality, objectivity and transparency ( ). above all, who needs to ensure all geographic regions establish health norms and structures that facilitate the transfer to poor countries of economic and technical assistance related to health. the need for increased global capacity to deal with infectious diseases is what drives the creation of a collaborative framework for epidemic alerts and responses to public health emergencies that are of international concern. such a structure should guarantee the highest level of security against the spread of disease with the least possible interference in other globalized processes such as commerce or travel. the best way to prevent the international spread of diseases is through opportune detection of and intervention into public health threats, while the problem is still limited. this requires early detection of unusual events the largest ebola outbreak ever recorded was successfully controlled in uganda in through the efforts of the ugandan government and an international team coordinated by the global outbreak alert and response network (goarn). more than ebola cases were isolated and treated and , contacts were tracked. after initial containment of the outbreak, follow-up was carried out through a community-based early warning surveillance system, establishment a field laboratory and creation of an isolation ward. goarn provided logistic support and coordination in the field, which made quick and effective control of the outbreak possible ( ). through national epidemiologic surveillance and international coordination as part of an effective response to public health emergencies of international importance. when common challenges exist, common strategies are necessary to find solutions, as is sharing high-quality information in order to provide effective, evidence-based responses. globalization has had multiple repercussions on international health, including the dissemination of certain infectious and vector-borne diseases, greater reach for bioterrorism and new health behaviors, among others. against this global backdrop, cooperation among countries would seem the best way to ensure worldwide progress in public health matters ( ) . however, international-and specifically north-southcooperation on actions to promote greater health should not be limited to the control of communicable diseases. particularly in many poor countries, it is important to reduce the burden of illness or ill health related to malnutrition ( ) . at times this may imply the existence of conflicting health priorities. international agencies and national institutions and governments will have to decide how limited resources can best be invested to achieve the greatest gains in the fight against ill health, be they through the control of communicable diseases or in the fight against malnutrition ( ) . of course, international cooperation on health issues cannot be the sole responsibility of poor countries; instead, developed and developing nations must collaborate. developed countries should commit to resolving global problems, making an effort to recognize precisely their global qualities even when originally they are located (in geographic terms) in developing countries. on their part, the less-developed nations should work towards guaranteeing the sustainability of their health policies. a specific proposal for dealing with issues such as these is the establishment of a global research council, which would contribute to making action-research more efficient as well as promoting faster uptake of new applied knowledge in the public health field. in general, in order to reach these goals, north-south collaboration is essential ( ) . the initiative for global eradication of poliomyelitis in has various lessons to teach us about international cooperation. in the first place, each goal should be defined based on strategies that are technically feasible for large geographic areas. secondly, before a strategy is implemented, an informed, collective decision should be negotiated and a consensus reached. in addition, financial risk should be minimal while the possibilities for implementation in a short time period should be maximized. finally, global health interventions should take into consideration the available infrastructure within the local health systems and ensure sufficient resources-financial and in terms of health care systems-as was the case in the eradication of poliomyelitis ( ) . there is a lack of efficacy in existing measures for stopping the spread of communicable diseases among countries. in order to create a foundation upon which to build communicable disease control strategies, to start with, health system infrastructure in developing countries must be strengthened (table ). this will involve the continual development of institutional capabilities for early detection and efficient and opportune intervention in emergencies linked to epidemics. for too long, many international agencies have given priority to other matters, including managerial capacity. although these issues may be important, the end result has been the postponement of support for improving primary care. therefore, international support for the control of communicable diseases should begin to include resources for strengthening local health systems ( ) . although some aspects of health problems, priorities and policy have become global, most of the responsibility for communicable disease control continues to be exercised at the local level. therefore, a network for the ''global public good'' has been proposed to improve communicable disease control in developing countries. this initiative proposes that failures and omissions in collective efforts to control communicable diseases can be overcome through the following actions: a) providing additional or matching funds to those offered at the local level; b) promoting investment by developed countries in the health systems of less developed nations; c) offering joint strategies for the global control of communicable diseases; and d) guiding the political process that will establish mechanisms for financing global communicable disease control programs ( ) . in this context, an alliance of a number of agencies has been formed, including the united nations, the governments of developing countries, governmental donors in developed countries, private foundations and corporations and non-governmental organizations. the goal is to mobilize, manage and distribute additional resources for the control, to begin with, of hiv/aids, tuberculosis and malaria. one high priority in the use of funding is the purchase of vaccines. however, there is still no consensus on implementing a strategy for financing and improving the health services of poor countries ( ) , and this will be something that should receive priority in the near future. research, development and funding priorities in the health field vary greatly in different parts of the world (particularly developed vs. underdeveloped), something which is linked to the insufficient north-south transfer of investment in health. one of the reasons this situation exists is simply that communicable diseases make up a much larger proportion of the burden of disease in underdeveloped countries as compared to developed ones (see box ) ( ) . a related problem is that research priorities are different in richer countries where chronic diseases are a priority than in poorer nations where infectious diseases and malnutrition are of greater concern. even when chronic diseases constitute an important proportion of the burden of disease in developing (often middle-income) countries, research needs may be different from those in developed nations. specifically, interventions to prevent chronic diseases, or to improve adherence to treatment once acquired, which may be successful in developed countries can be either not feasible or inappropriate (in cultural, social or economic terms) in developing nations. in addition, the development of vaccines in developed countries, for the control of communicable diseases, can be of little use in poorer nations, where they may be ineffective given the existence of different viral strains or bacterium. quality of health care services is quite heterogeneous from one country to another, both when comparing developing countries with one another or with their developed country counterparts, which again implies different research and funding needs. finally, the high cost of patented medicines and medical technology limits their transferability from richer to poorer nations. the new health environment is highly complex and therefore the proposals being made to improve it are extremely heterogeneous ( ) . certain international agencies have contributed to successful inter-institutional and international collaboration on scientific capacity building, joint research programs and technology transfer. to establish the basis for north-south discussion and transfer of resources and technology, as well as south-south collaboration, these successful examples will need to be examined and learned from. the identification of the necessary conditions for developing sustainable research, control efforts and health services will also be essential elements in the control of communicable diseases. recently there has been growing interest in the study of how priorities for investment in health research are established in different parts of the world ( ) . there are a number of perspectives from which an analysis of these issues can be carried out, including a focus on the economic, health or human rights aspects of priority setting. in economic terms, there has been an increase in investment in health research, from billion usd in ( ) to . billion usd in ( ) . the health sector generates trillions of dollars at the global level; among the products and services to be invested in are prevention of disease and health promotion, as well as diagnosis and treatment. the world bank is the agency that provides the largest amount of health-related financing worldwide, at close to one billion usd each year. the world bank's principal health-related aims are to contribute to the improvement of the health of the poor and to the reduction of the impoverishing effects of disease, as well as increasing equitable access to health care and promoting sustainable financing for health systems ( ) . the . billion usd provided by the world bank for the fight against hiv/aids in recent years constitutes an example of how the emergence of a public health problem-specifically an emerging disease-can lead to the creation of new investment priorities in terms of health research, prevention activities and treatment. human development can be measured through three critical indicators: education, income and life expectancy, all of which interact in complex ways with health. the large north-south differences can be expressed in terms of these four elements and their reciprocal influences. these indicators would seem to indicate a lack of equity in the way health research priorities are established, which in turn translate into insufficient north-south transfer of applicable after antibiotics began to be used to treat tuberculosis patients in developed countries beginning in the s, the control programs for this disease underwent radical transformations in these nations and tuberculosis incidence and mortality rates declined steadily in the industrialized world. the developed nations began to ignore the disease, and resources available to developing countries for dealing with it dried up. the treatment options used in developed nations were unaffordable for developing countries, where instead strategies such as ambulatory care and passive case detection were preferred in order to lower treatment costs and avoid expensive mass screening. studies carried out in developing contexts produced useful schemes for other resource poor settings. investigation undertaken in india confirmed the effectiveness of treatment of tuberculosis in patients' homes and provided alternatives to costly mass screening. research supported by the ministry of health of tanzania provided the groundwork for the development of dots (directly observed treatment shortcourse), which is now the leading global intervention against tuberculosis. however, these research results were not applied in many poor countries, given the almost total absence of tuberculosis on the international health agenda and especially the lack of funding. it was not until tuberculosis incidence began to rise in developed countries such as the united states and a number of european nations in the s that international concern was again focused on this disease, including resources. at this juncture, the world bank made tuberculosis a priority and provided loans for the implementation of who-dots, after which countries adopted this scheme ( ) . health research results, technology and health investment. among the many reasons offered to explain this situation is that in rich countries most infectious diseases are not endemic, as opposed to the reality of many poor countries, where emerging infections (such as hiv/aids) and reemerging diseases (such as malaria, tuberculosis or cholera) are priority public health issues (see box ). perhaps the most heart-wrenching example of this is the fact that epidemiologic surveillance and especially therapeutic interventions for hiv/aids are not available in poorer countries, where the large majority of people living with the disease are concentrated ( % of people living with hiv/ aids reside in developing countries, and only % of the million people living with the disease in resource poor areas received antiretroviral treatment in ( ) . a communicable disease has been controlled if through public policy the spread of an infectious agent is restricted to its pre-epidemic status, which is to say that the epidemic has been reversed. on the other hand, a communicable disease is eliminated if it is sufficiently controlled to prevent the occurrence of an epidemic in a specific geographic area. control and elimination are achieved locally, but a disease is eradicated only if it has been eliminated in all geographic regions. thus, eradication is clearly the most difficult goal to achieve, although it has large advantages over control. the economic effects of eradication can be extremely favorable in that it not only reduces the infection but also eliminates the need for future vaccination efforts. eradication generally becomes feasible, from an economic point of view, when a disease is first eliminated in one or more of the richer countries. the incentives for participation by the poorer countries in eradication initiatives begin with the existence of an international control program, which allows them to take advantage of financial support for elimination efforts ( ) . to promote and facilitate participation by developing and developed countries in epidemiologic surveillance systems, as well as initiatives for the control, elimination or eradication of communicable diseases, poor countries need to develop their capacity for early detection, dissemination of precise and high quality information and a high degree of transparency ( ) . all countries should adhere to international regulations, including the international health regulation and those of the world trade organization. finally, developed countries should provide financial and technical support for countries undergoing emergencies linked to communicable diseases, because globally this is the only way they can guarantee the safety of their own populations and ensure the usefulness of their internal health-related investments. ultimately, developed countries should also share expertise, technology, and funds as a contribution to social justice, because health is a fundamental human right. infectious diseases, non-zero-sum thinking, and the developing world international law and communicable diseases el boletín de la organización panamericana de la salud, noviembre eid updates: emerging and reemerging infectious diseases eid weekly updates: emerging and reemerging infectious diseases, region of the americas eid weekly updates: emerging and reemerging infectious diseases gostin lo. international 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the international community resumen mundial de la epidemia del vih/sida: diciembre de eradication versus control: the economics of global infectious disease policies impediments to global surveillance of infectious diseases: consequences of open reporting in a global economy sars vaccine development after the initial efforts to eradicate malaria through the use of ddt beginning around the mid-twentieth century, although some areas achieved important reductions in malaria incidence and mortality, frequent resurgences of endemicity continued in a number of poor countries. the initial eradication strategies failed for a number of reasons, including the development of resistance to ddt, a lack of high quality epidemiological knowledge and managing capacity as well as the inadequacy of the health care systems that existed in less developed countries. although for at least two decades malaria ceased to be an international priority, research continued, including the development of antimalarial drugs and attempts at vaccine development supported by such international agencies as the who, the world bank, the united nations development programme (undp) and usaid. during the last decade of the twentieth century a different set of strategies was developed, including evaluation of national malaria situations by a number of african countries and joint efforts to strengthen malaria control programs by african governments and the who, which were financed primarily by the world bank but also with resources from g countries, the european commission and development banks. it was this transnational alliance of international agencies and national governments and a more complex and realistic appraisal of the work needed to control malaria (instead of relying on a single strategy, ddt use) that constituted perhaps the most important difference between these two phases in the fight against malaria ( ) . key: cord- -hz qj fw authors: viterbo, lilian monteiro ferrari; costa, andré santana; vidal, diogo guedes; dinis, maria alzira pimenta title: workers’ healthcare assistance model (wham): development, validation, and assessment of sustainable return on investment (s-roi) date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: hz qj fw the present study aimed to present and validate the worker´s healthcare assistance model (wham), which includes an interdisciplinary approach to health risk management in search of integral and integrated health, considering economic sustainability. through the integration of distinct methodological strategies, wham was developed in the period from to , in a workers’ occupational health centre in the oil industry in bahia, brazil. the study included a sample of workers, . % of which were men, with a mean age of . years (age ranged from to years). the kendall rank correlation coefficient and hierarchical multiple regression analysis were used for the validation of wham. the assessment of sustainable return on investment (s-roi) was made using the wellcast roi™ decision support tool, covering workers with heart disease and diabetes. wham can be considered an innovative healthcare model, as there is no available comparative model. wham is considered robust, with % health risk explanatory capacity and with an . % s-roi. it can be concluded that wham is a model capable of enhancing the level of workers’ health in companies, reducing costs for employers and improving the quality of life within the organization. more than ever, life, as we know, will never be the same. the world is currently experiencing the coronavirus pandemic (covid- ) [ ] , an unforeseeable health development that is affecting the entire global population, and consequently healthcare assistance models across the globe. there is now an urgent need to look at human health through the "one health" lens [ ] , to design and implement programs, policies, legislation, and research in a cooperative manner among all sectors of society to achieve better public health outcomes. in addition to the recognition of the success of the current healthcare models in the relief of pain and the treatment of multiple pathologies, several criticisms are gaining support, pointing out the limitations relating to the attention to patient health. these issues include approaches that take an undifferentiated view of the individual, which is focused exclusively on the part of the body that is sick; the focus on the curative actions of diseases, injuries, and damages; the advancement of medicalization; and the generalization of hospital care using technology. in the past, if a medical doctor was seen as a figure possessing the knowledge necessary to cure the patient, nowadays that figure is seen as one part of a team, with the patient being the final decision-maker in their health outcomes. the world health organization has chosen to strengthen people-centred care and integrated health services as priority strategies to transform health services to meet the health challenges of the st century [ ] . this favours the emergence of integrated care models, which are seen as possible solutions to the growing demand for improvement in the patient experience, especially in patients with chronic conditions. considering economic sustainability in the search for integral and integrated health, this study aims to present and validate a model of workers' healthcare, the workers´healthcare assistance model (wham), which embraces an interdisciplinary approach towards health risk management. in light of the literature review, the following three research hypotheses were formulated: hypotheses (h ). wham promotes integral and integrated care; hypotheses (h ). wham is robust and has greater explanatory capacity for workers' health risks; hypotheses (h ). wham is economically sustainable and provides a significant return on investment. a review of the literature in the field of occupational health highlights discussions relating to "assistance models", a term that varies based on the conceptualization, which can include "assistance modalities or technological models" [ , ] ; "ways to promote health" [ ] ; "assistance models" [ , , ] ; "technical, techno-assistance, and technical assistance models" [ , ] ; "modes of intervention" [ ] ; "attention models" [ ] [ ] [ ] ; and "care models". the result of this diversity of terms is the already identified difficulty in conceptualizing assistance models. healthcare assistance models are understood as technological combinations with different purposes, which are used to solve problems and meet needs within a given context and population and in a given territory (individuals, groups, or communities), to organize health services or to intervene in situations, depending on the epidemiological profile and investigation of health problems and risks [ ] . these logical systems organize the functioning of care networks, articulating the relationships between network components and health interventions. in turn, these are defined according to the prevailing view of health, demographic and epidemiological situations, and social determinants of health at a given time and in a given society and place [ ] . according to campos [ , ] , the conceptualization of an assistance model, technological model, or assistance modality must go beyond mere organizational and technical design, showing a new way of producing assistance actions anchored in the organization of the state. according to silva [ ] , biomedicine has become the hegemonic model in the provision of health services in brazil and other countries around the world, influenced by accumulated knowledge and the paradigm of science. in this process, the daily requirements in the health sector stand out, such as the relationships between people; the involvement and co-responsibility of managers, health professionals, and patients in healthcare; as well as the bond, reception, and humanization of healthcare assistance practices [ ] . from a technological point of view, there is a predominance of the use of the so-called "hard technologies" (equipment), to the detriment of light technologies (professional-patient relationships) [ , ] . thus, diagnostic tests are a priority, but patients are not necessarily considered in terms of their suffering. this approach has been the target of criticism at the international level, starting from the s and gaining greater importance in the second half of the s [ , ] . in terms of the biomedical model, there is a certain neglect of the importance of the determinants of the health-disease process; that is, the focus on the disease and not on the elements that contribute to health promotion, underestimating that cultural, ethical, and social aspects condition lifestyles and that these are also determinants in the same process [ , , ] . merhy [ ] contributes to the debate about the need to change the hegemonic assistance model, arguing that it is necessary to impact the core of care. in this sense, it is necessary to invest in relational-type light technologies, focusing on the needs of users and reversing the investment in hard or light-hard technologies, which can be translated into standards, equipment, and materials. thus, light technologies are used and combined with people and resources to achieve certain objectives, which are gathered in an organized manner and consolidated as essential elements of health services [ ] . regardless of the scope, health services are always complex. the processes are standardized by regulatory bodies, service providers, and class representatives, among others. they have highly specialized and qualified workers who, belonging to different class councils, have interests that do not always converge [ ] . team composition characteristics in health services must be highlighted, recognizing these team members as the main actors responsible for the implementation of technologies aligned to a healthcare assistance model. faria [ ] draws attention to the fact that actions performed in a given place to deal with a certain problem may not apply to other situations, considering the historical-political context that influences a situation. therefore, the use of healthcare assistance models invariably requires the selection of certain constructs that support them. thus, they can be used in an alternative or adapted way, as long as they enable the achievement of similar results. to incorporate new health needs, healthcare assistance models can be considered to have influenced the organization of care models, being more focused on specific populations, such as the chronically ill. a comprehensive care model defines how health services are offered, providing the best care and service practices for a person or population group as they evolve through a condition, injury, or event, aiming for people to receive the right care, at the right time, by the right team, and in the right place [ ] . the field of occupational health is a fertile environment for the development of interdisciplinary practices [ ] [ ] [ ] [ ] , as it encompasses knowledge from different disciplines, requiring constant and complex interactions between professionals in the fields of epidemiology, the environment, engineering, and healthcare, among others. the framing of occupational health in a biomedical healthcare assistance model favours the development of disjointed and ineffective interventions regarding the needs presented by workers, while the biopsychosocial model is often used in their work environments. according to annadale [ ] , the biomedical healthcare assistance model only focuses on the physical processes, i.e., the pathology, biochemistry, and physiology of a disease, neglecting the roles of social factors or individual subjectivity. in this context, it is necessary to discuss a model of assistance in occupational health that is capable of reviewing the central characteristics of the biomedical healthcare assistance model, including: (i) organization of practices focused on the identification of signs and symptoms and the treatment of diseases, with health promotion not being a priority; (ii) assistance is organized based on individual spontaneous demand, with an emphasis on specialization and the use of hard technologies; (iii) the work is developed in a fragmented, hierarchical manner and with inequality across different professional categories; (iv) difficulty in implementing the integrated care due to the lack of understanding of the individual as a multidimensional human being, as well as the lack of communication and integration between the services involved; (v) health planning is seldom used as a management tool; (vi) the training of health professionals is specialized, based on the hegemony of scientific knowledge; and (vii) themes such as interdisciplinary, people-centered care, attachment, and welcoming are not prioritized. another aspect of great relevance in the current global context of scarcity of resources, particularly in the current context of covid- , is the prioritization of investments ineffective, integral, and integrated interventions, which can be achieved through a model that contemplates the management of occupational health risks, considering the social health determinants [ , ] , global disease burden [ ] , environmental aspects [ , ] , sustainable development goals [ , ] and in particular, working conditions that affect an individual's health [ ] . in the current context, the effectiveness of a healthcare assistance model must include economic sustainability in addition to health gains, to know how much the company has earned due to investments made in a certain area, with the sustainable return on investment (s-roi) being a very important metric for this assessment. measuring the s-roi [ ] [ ] [ ] of preventive programs is not an easy task, due to the large number of variables that influence this calculation. the main variable is patient health, which can improve or worsen unpredictably. analyzing the s-roi in preventive programs identifies the financial impact a program generates concerning the amount invested, which must be considered in the long term. disease prevention actions bring future returns, mainly to the reduction of healthcare assistance costs. if the individual participates in preventive programs, the probability of developing diseases or discovering them in advanced stages decreases. over the past years, several studies [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] have addressed this issue and there is growing evidence that workplace programs can generate acceptable financial returns for employers investing in them. a study of johnson and johnson employees [ ] showed a difference in the increase in the average annual costs of internment between workers involved and not involved in lifestyle improvement programs and changes in the workplace, representing $ and $ , respectively, thus representing a considerable increase in percentage terms. the study by munir et al. [ ] aimed to conduct a cost-benefit analysis of the stand more at work (smart) workplace intervention, designed to reduce sitting time. a net saving of $ . ( % ci; $− . ; $ . ) per employee was found as a result of productivity increase. peik and others [ ] applied the research and development (rand) europe model, a program designed to expand access to up to evidence-based clinical preventive services for all employees and eligible family members, as part of a unique global health initiative at the country level to estimate the return on investment over a five-year timeframe. the study concluded that this program generates a global return of $ . -$ . (after investment cost). gao and co-workers [ ] assessed the economic performance of a workplace-delivered intervention to reduce sitting time among desk-based workers. the incremental cost-efficacy ratios ranged from $ . /minute reduction in workplace sitting time to $ . /minute reduction in overall sitting time. the intervention was cost-effective over the lifetime of the cohort when scaled up to the national workforce, and provides important evidence for policy-makers and workplaces regarding the allocation of resources to reduce workplace sitting. the present study was carried out from to , in a workers' occupational healthcare centre in the oil industry in bahia, brazil. it involved the integration of distinct methodological strategies for the development of wham, such as the development of a conceptual model, action research, statistical validation, and s-roi analysis. the study involved two experts who had been working in the field of occupational health for fifteen years, with an emphasis on ergonomics and health management, an interdisciplinary approach, and a database composed of a population group and sample of workers, numbering and individuals, respectively (table ) . data analyses were carried out using spss version for windows (ibm corporation, new york, ny, usa). diagnostics and intervention prevalence were presented as absolute and relative frequencies. correlations among modifiable health risk factors and health outcomes were performed through the kendall rank correlation coefficient. correlations among health indicators and the interdisciplinary risk coefficients were also performed using the kendall rank correlation coefficient. hierarchical multiple regression analysis was used to calculate the independent contributions of occupational medicine interdisciplinary, dentistry interdisciplinary, physical education interdisciplinary, nursing interdisciplinary, and nutrition interdisciplinary risk coefficients, to provide an estimate of incremental variance accounting for the workers' health risk index (whri) [ ] . this index had already been published, resulting from the classification of workers into three risk ranges-"low", "moderate", and "high". the durbin-watson test was applied to detect the presence of autocorrelation at lag in the residuals (prediction errors), through which the hierarchical multiple regression analysis multicollinearity was verified. to lead the application of the wham, the "guidelines for implementing the workers' healthcare assistance model (wham)" were developed, which are presented in the supplementary materials (word s ). the "workers' healthcare assistance model" is understood as the organization of the conditions necessary to carry out a person-centred care process, about the method, staff, and instruments. the term "process" used in the context of healthcare makes it possible to identify, understand, describe, explain, and predict the needs of a person, family, or community at a given moment in the health and disease process, demanding professional care by health specialists. therefore, wham presupposes a set of actions, through certain means of action, regulated by a course of thinking; that is, through a conception of workers' health, wham's origin and its potential to transform itself or to be transformed. to compose the wham, the interdisciplinary workers' health approach instrument (iwhai) [ ] , a tool that had already been published, was used as a data collection instrument, aiming to collect data from health indicators. to map the diagnoses, the health taxonomies were used, while the whri [ ] was used to prioritize the health risks of the workers. figure shows the main stages of integrating the wham. int. j. environ. res. public health , , x of through the kendall rank correlation coefficient. correlations among health indicators and the interdisciplinary risk coefficients were also performed using the kendall rank correlation coefficient. hierarchical multiple regression analysis was used to calculate the independent contributions of occupational medicine interdisciplinary, dentistry interdisciplinary, physical education interdisciplinary, nursing interdisciplinary, and nutrition interdisciplinary risk coefficients, to provide an estimate of incremental variance accounting for the workers' health risk index (whri) [ ] . this index had already been published, resulting from the classification of workers into three risk ranges-"low", "moderate", and "high". the durbin-watson test was applied to detect the presence of autocorrelation at lag in the residuals (prediction errors), through which the hierarchical multiple regression analysis multicollinearity was verified. to lead the application of the wham, the "guidelines for implementing the workers' healthcare assistance model (wham)" were developed, which are presented in the supplementary materials (word s ). the "workers' healthcare assistance model" is understood as the organization of the conditions necessary to carry out a person-centred care process, about the method, staff, and instruments. the term "process" used in the context of healthcare makes it possible to identify, understand, describe, explain, and predict the needs of a person, family, or community at a given moment in the health and disease process, demanding professional care by health specialists. therefore, wham presupposes a set of actions, through certain means of action, regulated by a course of thinking; that is, through a conception of workers' health, wham's origin and its potential to transform itself or to be transformed. to compose the wham, the interdisciplinary workers' health approach instrument (iwhai) [ ] , a tool that had already been published, was used as a data collection instrument, aiming to collect data from health indicators. to map the diagnoses, the health taxonomies were used, while the whri [ ] was used to prioritize the health risks of the workers. figure shows the main stages of integrating the wham. the data collection stage aimed to identify health problems, as well as the efficient and targeted recording of the workers' needs in its broadest sense. for this, the iwhai [ ] was chosen. it allows structured data collection, covering the disciplines of medicine, dentistry, nursing, nutrition, and physical education, as well as environmental, occupational, behavioural, personal, and metabolic the data collection stage aimed to identify health problems, as well as the efficient and targeted recording of the workers' needs in its broadest sense. for this, the iwhai [ ] was chosen. it allows structured data collection, covering the disciplines of medicine, dentistry, nursing, nutrition, and physical education, as well as environmental, occupational, behavioural, personal, and metabolic factors. it is composed of in dimensions with indicators, totalling sub-indexes with closed response coding, where zero represents non-existent or inadequate control of risk and four represents optimal control of risk, arranged in the following scale: = non-existent or inadequate; = tolerable; = reasonable; = good; = excellent. for the diagnostics mapping stage, it was necessary to define taxonomies that encompass the complexity of the workers' health field, especially those related to the health, environment, and work triad. the following codes were used for medical, dental, nursing, nutritional, and physical education factors: (i) international classification of diseases (icd ) [ ] ; international classification of nursing practice (cipe ® ) [ , ] ; international dietetics and nutritional terminology (idnt) [ ] ; and the international classification of functioning, disability, and health (icf) [ ] . for the intervention design stage, it was necessary to define classifications that encompass proposals for interventions, which include ecological and occupational care. for each mapped diagnosis, an intervention must be associated. during the attendance of the worker, priority is given to diagnoses for health indicators that are classified as control or health conditions: = non-existent or inadequate; = poor; = reasonable. this consists of a discussion amongst the interdisciplinary health team to validate the perceptions [ ] raised by professionals in each area during the attendance of workers, sharing the diagnoses and interventions proposed by each discipline. the iwhai [ ] was used as a guiding instrument for data collection. for support of the team decisions regarding the hierarchy of priority interventions, the whri [ ] was used, allowing multidisciplinary (by dimension) and interdisciplinary (association of all dimensions) risk classifications. the classifications comprise three ranges: "low", "moderate", and "high". since % of the sample age is above years and the gender proportion of male to female is very high, the effects of these factors were controlled in this step by the whri [ ] assessment. as the workers' ages increase, the risk indicator also increases; the same happens for male and female workers for some sex-related diseases, such as the higher susceptibility by men to develop cardiovascular diseases and alcohol abuse. for this reason, when whri [ ] is applied, each worker will have two risk indicators influencing the indicators of health behaviours and outcomes: a risk indicator related to the workers' age, whereby the older the worker, the higher their risk indicator; and another risk related to their sex, whereby female or male gender will have different impacts on health behaviours and outcomes. the final whri [ ] score is mediated by the workers' age and sex. the whri [ ] dimension that has the greatest weight in the interdisciplinary context is designated as the worker case manager (wcm) and will assume technical responsibility concerning care management. the care plan (cp) is an interdisciplinary document, composed of relevant iwhai indicators with their respective diagnoses and associated interventions, in addition to the definitions of the implementation and deadline. for the implementation of the cp, the wcm must bring together the interdisciplinary intervention team (iit), ratify the cp, and proceed with the treatment of the proposed actions through interdisciplinary assistance, group work, and collective and environmental interventions. after validation of the cp by the iit, the workers are involved in discussing the cp and implementing it at the individual level. the assessment stage deals with the follow-up and monitoring of the workers to the effectiveness of the implemented health interventions. for this, it is necessary to systematically reassess the whri [ ] . the attendance took place in a single period (shift) by each member of the interdisciplinary team, with an average time of min for each consultation and a total time of . h for each worker in the health service. to validate the wham, the data collected in were used in a representative sample of the population of workers, where attendance by the interdisciplinary team occurred at the same time. through statistical tests, the intention was to identify the prevalent diagnoses and interventions, how the modifiable factors are related to health outcomes in this sample, and the impact each dimension has on the whri [ ] , i.e., if the joint use of these dimensions contributes to greater robustness and explanatory capacity of the wham. to assess the cost-benefit (cb) relationship of implementing wham, interventions directed at workers with coronary heart disease (chd) and diabetes in the period ranging from to were analyzed. the effectiveness of the intervention was based on the results of epidemiological studies over this period. brazilian national data were used to estimate the average annual benefits of preventing direct medical costs for diseases. the analytical tool wellcast roi™ [ ] , developed to justify the approval of disease prevention and management programs, was used to calculate the s-roi. for this, the following steps were taken: (i) determine the incidence of the pre-program disease; (ii) determine all costs associated with the disease, either medical costs (for chd patients, the framingham model [ ] was used to calculate incidence pre and post-program for a period of years, assuming changes in low-density lipoprotein (ldl) cholesterol, and systolic and diastolic pressure risk factors; for patients with diabetes mellitus, the reduction in the progression of diabetes comorbidities over years was calculated, based on the reduction of glycemia, considering the retinopathy, kidney disease, neuropathy, and microangiopathy comorbidities) or economic costs (monthly salary data, loss of daily productivity, medical inflation rate, among other rates estimated by wellcast roi™); (iii) define the program and its cost; (iv) determine the effectiveness of the program in reducing costs; (v) subtract post-program costs from pre-program costs to determine reductions; and (vi) apply the concepts of net present value (npv), internal rate of return (irr), and cb to determine the s-roi. in all stages of the study, the recommendations and guidelines of resolution / [ ] of the brazilian ministry of health on ethical aspects regulating research with human beings, approved by the research ethics committee of the bahia school of medicine and public health and certificate of presentation for ethical consideration (caae) . . . , were followed. all subjects gave their informed consent for inclusion before participating in the study. the prevalent diagnoses and their respective interventions by dimension are presented in detail in table . in the physical education dimension, the most prevalent diagnosis is "regular aerobic capacity" ( . %), with the most prevalent intervention being "encourage thinking about starting a physical activity program, warning about the harm of physical inactivity" ( . %). in the field of nursing, the "impaired ability to perform leisure activities" ( . %) stands out as the most prevalent diagnosis, followed by the need to "promote ergonomic comfort" ( . %) as the most necessary intervention. in the field of medicine, "primary essential hypertension" emerges as the diagnosis with the highest prevalence among workers ( . %), preceded by "encourage health-seeking behaviour" ( . %) as the intervention with the greatest application within this sample. at the nutritional level, "excessive alcohol intake" is the most prevalent ( . %), with the intervention with the greatest application focusing on the need for "adequate macronutrients" ( . %). finally, in the field of dentistry, the most prevalent diagnosis is identified as "other somatoform disorders related to stressful events-bruxism" ( . %), with the predominant intervention being "guide to restorative treatment with external dentist" ( . %). table shows the statistically significant correlations between modifiable health behaviours and health outcomes. moderate correlations in table (τb ≥ . ) are identified as follows: between diabetes mellitus and altered blood glucose (τb = . ), energy balance intake (τb = . ), and the level of food knowledge (τb = . ); between arterial hypertension and the contemplation stage for physical activity (τb = . ); between the musculoskeletal pathology and the feeling of pain (τb = . ); between psychiatric pathology and energy balance intake (τb = . ); between triglycerides and energy balance intake (τb = . ); between caries and oral hygiene quality (τb = . ); between periodontal disease and periodontal condition (τb = . ), oral hygiene quality (τb = . ), level of food knowledge (τb = . ), altered blood glucose (τb = . ), energy balance intake (τb = . ), and simple carbohydrate intake (τb = . ). the results are shown in table show which indicators are most correlated with each coefficient of each dimension of interdisciplinary risk. the values presented in table make it clear which indicators are most correlated with multidisciplinary risk; the worse an indicator is, the more the risk increases. thus, in the field of physical education, it appears that the indicator of the contemplation stage for physical activity is the one that is most strongly correlated (τb = . ). in nursing, the physical aspects of ergonomic risks have the most significant correlation (τb = . ). in the field of medicine, diabetes mellitus is the most disturbing indicator (τb = . ). in nutrition, alcohol consumption presents the strongest correlation (τb = . ). finally, the highest correlation of all is for oral lesion on soft or hard tissue, which is the most significant indicator in the field of dentistry (τb = . ). hierarchical regression analysis was applied to understand whether the variables or dimensions under analysis explain a statistically significant amount of the variance of the dependent variable to be tested-in this case, the whri [ ] ( table ) . a comparison of stages is made by gradually adding each independent variable in each stage, to understand if the combination of the dimensions explains more than considering them separately. table . hierarchical multiple regression analysis scheme. step step step step step after analyzing the robustness of wham, its economic sustainability was assessed using the wellcast roi™ tool. for the analyzed time period and based on the npv of usd , . /per worker, the irr of . %, and the cb of . : , the s-roi was determined, suggesting that wham is economically sustainable. given its complexity, the field of healthcare requires the mobilization of specialists from different areas, with the aim of promoting comprehensive and integrated care for workers. based on an approach aimed at changing behaviors and adopting healthier lifestyles, going beyond the mere medicalization or treatment of diseases, the interdisciplinary care on which the wham model is based resulted in the data presented in table . in view of the most prevalent diagnoses identified for each of the integrated dimensions, an intervention was generated that promotes worker autonomy and the maintenance of healthy lifestyles and behaviors, such as physical activity, healthy eating, non-consumption of alcohol and tobacco, good oral hygiene, balanced social and environmental relations, and decent work habits [ ] . at this level, hypertension or diabetes mellitus diagnosis is highlighted, suggesting healthy behaviors or healthier eating habits interventions. as eng and collaborators [ ] state, the workplace is a key space for guidance around healthy behaviors and the reduction of non-communicable diseases (ncds), such as diabetes mellitus and arterial hypertension. viterbo and co-authors [ ] report that long-term interdisciplinary practice has had very positive and significant effects on reducing ncds. hochart and lang [ ] also mention in their study that the implementation of a comprehensive care program in the workplace with the aim of modifying health risk behaviors resulted in a decrease in workers in the high and medium risk ranges and in the maintenance of health for those that were in the low risk range. the same is true for the issue of oral health, a problem that is related to other serious diseases [ , ] , and which is solved through the implementation of regular programs for the adoption of oral hygiene behavior among workers, as reported by viterbo and collaborators [ ] . supporting these results, and in order to reinforce the importance of an integral look at workers' health, table presents the results between the behaviors (modifiable factors) and the results for workers' health. an overview of these results makes the connections between behaviors and health outcomes even more evident, as well as between the results themselves. in this case, an individual look at a worker would not allow one to understand them as a whole, contributing to fragmentation. certain associations exemplify this idea, namely between the level of food knowledge and the type of food, identified by the energy balance intake, altered blood glucose, and diabetes mellitus. a similar relationship was identified in a review by sami and co-authors [ ] , in which guidance towards healthier eating practices reduced the level of diabetes and prevented associated complications. the study by holynska and colleagues [ ] showed that the level of food knowledge is effectively related to nutrient intake, as this study also demonstrated. in line with this, breen et al. [ ] argued that the level of food knowledge enhances the choice of food, thus optimizing the quality of life of people with diabetes. table shows the results of the indicators that are most correlated with the risk of each analyzed dimension, making it possible to identify those that contribute most to the increased risk in that dimension. the strongest correlation belongs to the field of dentistry, more specifically for oral lesions increasing the health risk of these workers. according to warnakulasuriya et al. [ ] , conducting screening programs using valid visual inspection method to detect potentially malignant oral disorders within a workplace is not only feasible, but also effective. in terms of physical activity, the indicator that has the strongest correlation is that of the contemplation stage for physical activity; that is, the predisposition to start a physical activity. in the review by jirathananuwat and pongpirul [ ] , the studies analyzed demonstrated that the workplace can play an important role in promoting regular physical activity among workers. ergonomic risks in the workplace are, in this context, assumed to be the most correlated with risk in the field of nursing. this has been documented in several studies, namely by skovlund et al. [ ] and welch et al. [ ] . since workers spend long hours of their day at the workplace, an additional concern regarding workplace ergonomics must be considered, as correct adaptation will result not only in promoting the well-being of workers, but also in reducing medical costs for employers, as reported by munir et al. [ ] , gao et al. [ ] , and welch et al. [ ] . in terms of pathologies, diabetes mellitus is the indicator that most contributes to risk in the dimension of medicine. in the reviews by hafez [ ] and gan [ ] , the workplace is an important space for effective reduction of diabetes mellitus. some of the results in this study will have a direct implication in the workplace context, thus a more detailed specific analysis is necessary. the results regarding the wham robustness (table ) make it clear that the combination of technical and scientific knowledge in the work context results in a better understanding of the workers' global health. this result makes it possible to effectively verify that the interdisciplinary approach translates into gains in health, and that it must be adopted as a matrix in all work contexts, particularly those referring to a higher exposure risk and greater number of employees, as already identified in the studies by viterbo et al. [ ] , clark et al. [ ] , and costa et al. [ ] . considering that health promotion and prevention actions can influence the health habits and behaviors of workers, they can also reduce health costs. the literature review [ , [ ] [ ] [ ] suggests that programs based on behavior change theory and using personalized communication and individualized counselling for high-risk individuals are likely to produce a positive return on the amount invested in these programs. the assessment of s-roi in the specific model under investigation (wham) corroborates other studies carried out in the workplace [ , , , ] , showing positive financial results and reinforcing the advantages of applying wham, which in addition to directing investment in health strategies that are proven to be a priority, enables the optimization of financial resources, resulting in an s-roi of . % for interdisciplinary, integral, and integrated interventions for the community of workers with a high risk level. the search for a healthcare model for workers that is oriented towards integrated care, expanded health needs, economic sustainability, and which overcomes the problems arising from the hegemony of the biomedicine paradigm, such as the excessive use of technologies and focus on curative actions of diseases, is one of the great challenges of the brazilian health system today. this scenario is strongly present in brazilian scientific production and is reflected in national and international policies through legislation and public initiative. the results obtained with the practical application of wham in the oil industry in bahia, brazil, demonstrated the potential of the model, where the articulated and hierarchical management of the various indicators of workers' health makes it possible to direct practices aimed at the cause and not at the effect or symptom. at the individual level, the model presented an interdisciplinary diagnosis of the health conditions of each worker, correlating the modifiable health factors and their respective impacts. the presentation of information to individuals promoted autonomy and empowered workers to change behaviors that negatively interfere with health conditions. at the collective level, the application of the model demonstrated the correlation between health indicators and interdisciplinary risk in the studied context, encouraging the creation of strategies aimed at the most critical conditions, as well as the design of preventive interventions. the robustness of the model highlights this same potential, in addition to the related optimization of financial resources of . % for interdisciplinary interventions. the absence of a similar model in occupational health is a limitation of this study since comparative analyses in the context of this work are not possible. the application of wham in different healthcare contexts is suggested in future studies, as well as carrying out analyses of the model's effectiveness by comparing the population's epidemiological results and studying the s-roi. the different theoretical contributions to the theme of this study, as well as the results found, lead to the understanding that wham can be considered as a model capable of encompassing the complexity of the field of occupational health, considering the interdisciplinary approach, risk management, and comprehensive and integrated care, in addition to accounting for economic sustainability for companies investing in healthcare. the proximal origin of sars-cov- the one health concept-the health of humans is intimately linked with the health of animals and a sustainable environmen health services delivery programme division of health systems and public health duas faces da mesma moeda: microrregulação e modelos assistenciais na saúde suplementar. in [national agency for supplementary health. two faces of the same coin: microregulation and care models in supplementary health modelos assistenciais e unidades básicas de saúde: elementos para debate [care models and basic health units: elements for debate modelos de atenção e vigilância da saúde [health care and surveillance models cartografia do trabalho vivo modelos de atenção e a saúde da família [models of care and family health programa saúde da família: a construção de um novo modelo de assistência [family health program: the construction of a new care model modelos de atenção à saúde no brasil [health care models in brazil in políticas e sistema de saúde no brasil communication on health and safety risk control in contemporary society: an interdisciplinary approach. ciência saúde coletiva saúde coletiva cuidado das condições crônicas na atenção primária à saúde: o imperativo da consolidação da estratégia da saúde da família [the care of chronic conditions in primary health care: the imperative of consolidating the modelos assistenciais em saúde: desafios e perspectivas [health care models: challenges and perspectives the health care model: concepts and challenges for primary health care in brazil technology of relations as device of humanized attendance in basic attention to health in the perspective of access, sheltering and attachment modelos tecnoassistenciais em saúde: o debate do campo da saúde coletiva [techno-health care models: the debate in the field of public use of light technologies as a strategy for changing the health profile of workers with chronic conditions in the oil industry administração em saúde: autogestão de consultórios e clínicas dos modelo assistencial e atenção básica à saúde [care model and primary health care understanding the process to develop a model of care: an. aci framework; agency for clinical innovation implementation of an interdisciplinary approach to promote workers global health status in the oil industry, brazil ( - ) interdisciplinarity: an articulating movement in the field of worker's health significados e limites das estratégias de integração disciplinar: uma reflexão sobre as contribuições da saúde do trabalhador resgatando 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mediterranean area desenvolvimento sustentável e saúde do trabalhador nos estudos de impacto ambiental de refinarias no brasil impact of working environment on job satisfaction a cost-benefit analysis of three older adult fall prevention interventions a review and analysis of the health and cost-effective outcome studies of comprehensive health promotion and disease prevention programs the health and cost benefits of work site health-promotion programs impact of worksite health promotion on health care costs and utilization. evaluation of johnson & johnson's live for life program worksite health promotion: its evolution and the johnson & johnson experience a return on investment evaluation of the citibank, n.a., health management program building program participation: strategies for recruitment and retention in worksite health promotion programs health spending projections through : modest changes obscure part d's impact. health aff. (millwood) impacts of workplace health promotion and wellness programs on health care utilization and costs: results from an academic workplace a cost and cost-benefit analysis of the stand more at work (smart work) intervention projected return on investment of a corporate global health programme economic evaluation of a randomized controlled trial of an intervention to reduce office workers' sitting time: the "stand up victoria health risk assessment in oil industry in bahia, brazil: the worker's health risk index (whri) development and validation of an interdisciplinary worker's health approach instrument (iwhai) world health organization icd- -international classification of diseases th revision. the global standard for diagnostic health information sistematização da assistência de enfermagem em unidade de terapia intensiva classificação internacional para a prática de enfermagem: instrumental tecnológico para a prática profissional [international classification for nursing practice: technological instrument for professional practice academy of nutrition and dietetics. international dietetics and nutritional terminology (idnt) reference manual: standard language for the nutrition care process world health organization. international classification of functioning, disability and health; world health organization health behaviors as a mediator of the association between interpersonal relationships and physical health in a workplace context the framingham heart study and the epidemiology of cardiovascular disease: a historical perspective approves regulatory norms of research involving human beings; national health council resolution no of december impact of a workplace health promotion program on employees' blood pressure in a public university impact of a comprehensive worksite wellness program on health risk, utilization, and health care costs periodontitis and diabetes: a two-way relationship the association between oral hygiene and periodontitis: a systematic review and meta-analysis. int effectiveness of an oral health program among brazilian oil workers. in occupational and environmental safety and health ii effect of diet counseling on type diabetes mellitus the level of nutrition knowledge versus dietary habits of diabetes patients treated with insulin diabetes-related nutrition knowledge and dietary intake among adults with type diabetes is workplace screening for potentially malignant oral disorders feasible in india? promoting physical activity in the workplace: a systematic meta-review association between physical work demands and work ability in workers with musculoskeletal pain: cross-sectional study process evaluation of a workplace-based health promotion and exercise cluster-randomised trial to increase productivity and reduce neck pain in office workers: a re-aim approach workplace interventions to prevent type diabetes mellitus: a narrative review shift work and diabetes mellitus: a meta-analysis of observational studies developing and evaluating an interdisciplinary clinical team training program: lessons taught and lessons learned communication of environmental risks to potentially exposed workers: an experience in the oil industry, bahia, brazil. in occupational and environmental safety and health ii financial impact of health promotion programs: a comprehensive review of the literature meta-evaluation of worksite health promotion economic return studies: update a review and analysis of the clinical and cost-effectiveness studies of comprehensive health promotion and disease management programs at the worksite: update vi - key: cord- -x sfwqnk authors: butler, colin d.; higgs, kerryn; mcfarlane, rosemary anne title: environmental health, planetary boundaries and limits to growth date: - - journal: encyclopedia of environmental health doi: . /b - - - - . - sha: doc_id: cord_uid: x sfwqnk published almost years ago, the limits to growth remains relevant to contemporary environmental health, though, paradoxically, this relevance is scarcely recognized. the seminal ideas it presented provide a useful background, as do the later planetary boundaries analyses, with which to consider key issues in contemporary environmental health. to be more than reactive, it is necessary to understand the complexity and interactions of integrated environmental health risks, including the possibility of significant global population decline within the current century. this contribution provides an overview to the limits to growth, linking it especially to the “planetary boundaries” of climate change, biodiversity loss and novel entities (including artificial substances and genetically modified organisms). the gradual increase in the amount of primary energy required to generate useable energy is also argued to be an under-recognized contributing factor to the decline in real wages growth for much of the world’s population since then, although this aspect may be improving. these elements have positive and negative health effects, which we discuss. only ones that allowed civilization to continue without crisis. if the human economy maintained business as usual, the team found, it would collide with the physical realities of a finite planet by the second half of the st century, triggering social collapse. initially, the book received a positive response and some of the recommendations were adopted by several countries. canadian prime minister pierre trudeau and us president jimmy carter each commissioned studies of the impact of physical limits on the global future and their national prospects. although these studies examined the outlook only as far as , their conclusions to that date confirmed those of the original ltg study. right from the start, however, economists were critical, even abusive, creating a negative impression that persists in some quarters, todayddespite the rapidly accumulating evidence of the basic robustness of the ltg projections and assumptions. robert gillette, who attended the ltg launch for the journal science, noted that the "assumption of inevitable economic growth" represents "the very foundation" of economics. any "limit" to growth challenged this foundation. it is unsurprizing that most economists attacked the ideas vigorously, an assault that illustrates the conflict between the core assumptions of economists and those of the physical sciences. economics adopts a standard model where production and consumption exist in a circular flow, without a natural context. it is a world of business and individual, producer and consumer, labor and goods. the physical world, which supplies resources and provides a site where wastes can be discharged, is not seen as essential and does not affect the equations, though, occasionally, the concept of "externalities" (which can be negative or positive) is mentioned. ecological economists reject the argument that human activity is independent of nature, which they consider a conceit. instead, nature is accepted as the indispensable foundation of human activities. physics really matters; questions of depletion and pollution are inescapable. several researchers have compared the mit projections with what has actually happened since, establishing that the correlation between the standard run and real world trends over the intervening years is extremely close. one of these researchers, graham turner, compared the standard run's modeled trajectory with years of historical data (see fig. ). he concluded that the data for - approximated the standard run of the ltg model, although the figure shows a slight but favorable divergence for the trajectory of non-renewable resources, such as fossil fuels, phosphate and concentrated, rich sources of ores. systems ecologists charles hall and john day also compared the standard run with actual data to . despite the common perception that the ltg work had failed, the model's performance was not invalidated, unlike models made by economists which are rarely, if ever, accurate over such a long time span. in , jørgen randers, part of the original ltg team, using an updated model, compared the ltg projections with real world data up to . he found that real world outcomes have approximated the second ltg scenario, the "standard run with extra resources," or "pollution crisis." based on observed data further processed by turner (up to ) trent modelled by the ltg study ( - ) (ltg) peak health? c : population declines due to increasing cases of regional overload meadows et al. for - and updated by turner with data to . it also introduces the concept of "peak health." this is the point at which human population well-being reaches its zenith, if the ltg model (of decline this century) proves reliable. although the timing is imprecise, peak health will precede the exact moment of maximum population. peak health and unwanted population decline are not inevitable; even today they could be postponed, perhaps indefinitely, by enlightened policies and technological breakthroughs. many resource analysts have identified declining "energy return on energy investment" as a key to understanding the slowing of the rate of improvement of living standards for most people in high-income countries. in turn, these indicators reflect the decline in easily accessible fossil fuels. this subject will be returned to. it is important to understand that the broad trends described in the figure and used in the ltg model do not capture the entire world. no model can. these trends were chosen because they captured many aspects of the material world, both human and natural, including feedback loops and potential crises that might threaten the human economy and thus wellbeing. indicators of these trends were chosen for a number of reasons, including researchers' attempts to choose representative indicators that would faithfully reflect the trends, the need for parsimony and, especially back in , the difficulty of finding accurate data. the decline in population that is modeled is a logical consequence of the decline in resources per capita, whether non-renewable, or as food, industrial output and services. if these inputs decline, the modelers assume, so will human population, which depends on them. the concept of the ecological footprint is among the most important developments in thinking related to the ltg. devised in the s by william rees and mathis wackernagel, this measure enables ecological impacts (individual, national or global) to be quantified and compared. on one hand, it estimates the ecological assets required to produce the resources consumed by any discrete population; this includes food and fiber plants, livestock and fish, timber and other forest products, space for urban infrastructure and whatever "sinks" are needed to absorb the waste produced, especially carbon dioxide emissions. the unit of measurement adopted is the area of biologically productive land and water, usually expressed in hectares. on the other hand, the ecological footprint also estimates the productivity of a country's actual ecological assets (cropland, grazing land, forest land, fishing grounds, and built-up land). researchers using the ecological footprint methodology calculated that, while the world's biocapacity averages . ha. per capita, high-income "developed" countries greatly exceed this average. examples include the united states ( . ha. per capita) and the united kingdom ( . ha. per capita). the us, which has far more productive land available than the united kingdom, appropriates . times its own biocapacity through imports, and the united kingdom almost three times. many island nations and arid countries such as saudi arabia exceed their biocapacity by a factor of more than ten. the ecological footprint has the strengths and weaknesses of any aggregate indicator: the concepts and units are easy to understand by policy-makers and the public, but it does not encompass all aspects of human environmental impact (methane, e.g., is not integrated). this matrix needs to be used in conjunction with other indicators. another related development is the framework called "planetary boundaries," devised by a large team led by johan rockström (see following section). although the environmental health literature has long identified links between health and indicators used in the ltg model, such as food, services, and pollution, there has been little recognition among the health community, including within public health, of the possibility of a reduction in population this century. such reductions, as mentioned above, are forecast by most ltg scenarios, including the standard run (see fig. ). such a reduction, were it to occur, will have impacts on public health. there are a few exceptions to this generalization. in , the human ecologist frederick sargent, in an article in the american journal of public health, warned that human "interventions in and manipulations of the processes of the planetary life supportsystem (ecosystem) have produced a set of complex problems" (page ). in , the visionary socialist economist barbara ward co-authored "only one earth" with the microbiologist, pioneering "earth physician" and pulitzer prize winner, rené dubos. this book stated in part "the charge to the [ stockholm] conference was clearly to define what should be done to maintain the earth as a place suitable for human life not only now, but also for future generations" (emphasis added) (page xiii). health is implicit in this statement, as is sustainable development. in mcmichael, who was influenced by dubos, echoed sargent's term, writing in the foreword to his influential book planetary overload, that "the most serious potential consequence of global environmental change is the erosion of earth's life-support systems. yet, curiously, the nature of this threat to the health and survival of the world's living speciesdincluding our owndhas received little attention" (page xiii). a quarter of a century later, little has changed. although keynote talks by mcmichael and john last at the conference of the international epidemiological association warned of the dangers to global public health of global environmental change, there has been barely any recognition or follow up, at the broad integrated dimension. ltg receives little recognition now. a literature search for the term "limits to growth" in association with "health" reveals little other than work involving the authors of this contribution and their close collaborators. this is unfortunate. the persistence of single-issue approaches to address complex problems retards our ability to act effectively. this is the case where there is singular focus on climate change. the impact on human health and wellbeing is modified by many interacting factorsdincluding population, global demand and availability of resources and services and the waste and pollution we generate. other than noting the exponential growth of carbon dioxide in the atmosphere, ltg did not address climate change as such, but it modeled these factors as part of a complex system. although infrequently, the issues of resource depletion and population pressure have featured in some medical curricula, from at least the s, preceding publication of the ltg by over a decade. pioneering writers and speakers have included colin bertram, peter parsons, and roger short. john guillebaud, the world's first clinician professor of family planning and reproductive health, has repeatedly spoken on the issue of both consumption and population, to diverse audiences including medical practitioners, nurses, medical students and others, since . in , a special issue of the american journal of public health focussed on peak oil, an important aspect of ltg. a scattering of other articles in the health literature have mentioned peak oil, but ltg is far more than peak oil. it is also far more than global warming. the reasons for the general failure of the public health literature to engage with ltg are complex but include an incorrect belief that ltg was discredited, over-specialization within the public health community, political suppression of the core ideas, and a lack of funders. the issue has had very few champions. this lack of engagement is not from lack of evidence. the term planetary boundaries (pbs) was first published in . these boundaries were defined, initially, as referring to nine earth system processes (see table ), each of which had been, is and will be modified by human actions. the first planetary boundary paper (published in in ecology and society, subtitled "exploring the safe operating space for humanity") explicitly acknowledges its debt to the ltg framework. a "safe operating space" implies the existence of multi-dimensional limits, just as does the word "boundaries". nonetheless, the links between pbs and the ltg are mostly implicit. although the focus of the pb work is on identifying the criteria for a "safe operating space" for humanity, rather than that of other living species, the concept acknowledges that humans depend on the diversity of life on earth. the first pb argued to be outside the safe operating space is biological diversity. analogous to nine bodily systems (renal, hepatic, neurological and so on) the large multidisciplinary team ( co-authors) that was responsible for the first pb articles argued that these earth system processes can still provide useful services, even if functioning outside their optimal range. however, pushed too far, even one aberrant bodily function can cause death, and just one extremely disturbed earth system process might trigger catastrophic consequences for humanity. perhaps, for example, a precipitous loss of insects could disrupt pollination, food supply, and the survival of birds and other vertebrates. in turn, loss of birds might trigger additional crop losses, as their biological control of insects and other pests (i.e., of pests that do survive) is lost. another example is the reduced complexity of the microbiome of those who live in cities and other modified environments. this in turn has been hypothesized to be a causal role in the emergence of auto-immune diseases such as type diabetes. further, just as with bodily processes, earth system components are linked to, interact with, and are influenced by common causes. humans may live for decades with chronic illness, but die quickly if multi-organ failure develops. so too, earth system processes interact, but exceeding multiple planetary boundaries, either simultaneously or in close proximity, risks precipitating a steep decline towards a civilization-crippling condition. other writers have also commented on the similarities between the earth and the human system, including james lovelock, the originator of the gaia hypothesis and an early user of the term "planetary medicine." table shows links between planetary boundaries, ltg and human health. the exact extent to which we are breaching planetary boundaries is still being explored. the team's paper argued that two problems are already extremely dangerous (red zone) and two others are well on the way (amber zone), also noting that the designated boundaries are inter-related and most have overlapping implications. the team considers loss of biosphere integrity as the most critical problem. rates of extinction are reckoned to be at least times the background rate, possibly as much as , times. populations of vertebrate species declined by more than half between and and the biomass of wild mammals is now only about % of the total, which is dominated by humans and livestock. that remaining % is under siege, including for substances such as rhinoceros horns and pangolin scales, which have alleged therapeutic benefit, even though chiefly constituted of keratin, just as are fingernails. biological diversity of lower order organisms (within soils, among pollinators, and in the species traditionally utilized for plant-origin food, resources and medicines) are similarly in decline. also under deliberate attack are forests, especially species with valuable timber, or growing on land that can be used for crops, including oil palm. many forests are also at unintended risk, due to roads and global warming, each of which also exacerbates the risk of fire. global warming is also likely to further hasten biodiversity loss. in some cases biodiversity decline and climate change, acting together or independently, also promote the survival of new pests. infestations of tree borers, able to survive warmer winters in large numbers, render trees, forests and their associated animal life more vulnerable to disease and fire. humans, a form of life, depend on the fabric of other life on earth for their survivaldfor food, clean air and water, and numerous other ecosystem "services" (see glossary and below), as well as for novel substances, including drugs. at some level of bio-alteration the reduction in ecosystem services will reduce in a non-linear way that could cascade in a manner harmful to all civilization. smaller scaled examples include the collapse of regional fisheries or the decimation of regional harvests by novel diseases or pests, such as in ireland in the late s. the khapra beetle, a pest from south asia that has evolved insecticide resistance threatens significant (up to %) loss of rice, post-harvest, in some regions. devastating drought in the "dry corridor" of guatemala, el salvador and honduras has been blamed for contributing to the influx of migrants attempting to enter the united states between and the present ( ). for rockström, steffen and colleagues the second most pressing danger is the radical disruption of the biogeochemical cycles, particularly nitrogen and phosphorous. in nature, most nitrogen was inert in the atmosphere, though some was mobilized by bacteria and leguminous plants. applied as fertilizer, nitrogen has greatly expanded food production, but is now cascading through our rivers, groundwater and continental shelves, initiating algal blooms and dead zones. in the case of phosphorous, the other widely dispersed fertilizer, there is an added dangerdphosphate rock is a resource in decline, with grim implications for future agriculture, especially where populations will lack the financial capacity to import it, as prices rise. land-system change is argued to be in the "amber zone," close to crossing the boundary into extreme danger, if it has not already crossed it. millions of hectares of vegetation are still being cleared every year and wetlands continue to be drained. stocks of "blue carbon," stored in plants and trees associated with water, such as kelp and mangroves, are also under threat. land-system changes enable more food, fiber and other financially valued products to be grown, but amplify the harm to several pbs: biological integrity, climate and biogeochemical cycles. oil palm plantations are displacing tropical forests in asia, africa and, increasingly, latin america, where clearing already provides cattle pasture, soybean and sugar cane. such plantations involve the death of vast numbers of individual animals and the annihilation of immense tracts of tropical forest. this boundary is underpinned by the declining remainder of tropical, temperate and boreal forests. these forests have a major role in land surfaceclimate coupling. in addition, agricultural land-system change may ultimately result in land degradation giving rise to erosion, loss of topsoil, sedimentation of waterways and degradation of coastal zones. in dryland regions, degradation is referred to as desertification. large areas are affected. the united nations organization considers that billion people are at risk of desertification globally, half of whom live in africa where they face major challenges to water and food security. increasing urbanization also drives land-system change, typically in areas of high agricultural productivity. vast urban regions impact surface energy (through the "heat island" effect), alter hydrological and biochemical cycles, net primary productivity and biological diversity. they are also major foci of pollutants. as humanity becomes predominantly urbanized it is with these land systems that most of us have most intimate contact. also in the amber zone is climate change. remaining below the c target, which is thought to provide a reasonable chance of avoiding catastrophic climate change, necessitates technologies which do not yet exist for extracting carbon from the atmosphere. most nascent carbon reducing technologies require considerable energy, although new forms of cement may soon be feasible and environmental health, planetary boundaries and limits to growth affordable on a large scale. research since suggests that the c target may need to be adjusted downwards to provide a reasonable chance of avoiding calamitous warming, in which case climate change may already belong to the red zone. even if the commitments made at the paris conference of the parties are all honored, it currently seems likely to many analysts that global temperatures will be c hotter than pre-industrial times by and nearly c higher by . these estimates depend on a number of variables: whether nations will adopt more ambitious pledges in the near term; whether technologies will emerge that can, at a low energetic cost, suck carbon back out of the atmosphere; whether unknown tipping points will be crossed, forcing a temperature surge. if these variables prove unfavorable, the aspirational . c maximum target may be reached by the early s. there is no guarantee that the damage can be held to approximately c, in particular due to the risk of amplifying feedbacks such as the release of carbon dioxide and methane from the arctic, and/or the drying and burning of the amazon forest. the capacity of the ocean to absorb co is also declining. that will slow the rate of ocean acidification, but increase atmospheric heat trapping. even if temperature rise and rainfall intensity can be contained, crop yields will decline and many places will become unliveable due to excessive heat and humidity or coastal inundation. glaciers that act as a bank to store water and in some cases whose melt supplies electricity to billions in asia and south america will shrink, coral reefs and many other species will disappear, and significantdeven catastrophicdsea level rise will result. in greenland and along the entire coast of west antarctica ice shelves are already retreating or collapsing as warm seawater intrudes underneath, grounding lines retreat, and the glaciers behind them accelerate in their march to the sea. climate scientist james hansen and many glaciologists warn that the disintegration of the polar icesheets involves non-linear processes, and the timing, though still unknown, may be far quicker than assumed, and may include rapid, even unstoppable collapse of ice cliffs in series in parts of antarctica and greenland. the impact upon human wellbeing resulting from stress on biological diversity will be compounded by climate change and the fragmentation of society. for example, a complex economic and social fabric enables the importation of food and other resources to an increasing number of regions, some of which have been in this vulnerable situation for decades. such mechanisms are fragile. today, five countries are recognized as afflicted by famine: yemen, somalia, south sudan, n.e. nigeria and two regions of the democratic republic of the congo (kasai and tanganyika). in the long run, if climate change and other aspects of adverse ecological change intensify, then it is also possible that regions that are current net food exporters will also experience famine; if this evolves then conditions in food-importing regions will inevitably deteriorate. alongside these four major crises, the researchers also identify the threat from various forms of pollution. most of these are discussed elsewhere in this encyclopedia. however, we briefly discuss novel entities. novel entities is a recently introduced term, first identified as a planetary boundary by the pb team in , evolving from chemical pollution in the earlier pb publications. the pb team defines novel entities as "forms of existing substances, and modified life forms that have the potential for unwanted geophysical and/or biological effects." most novel entities have been generated in the anthropocene, the human-dominated era, defined roughly as the time since the start of the widespread combustion of fossil fuels, in the th century. they include synthetic molecules such as chlorinated fluorocarbons (cfcs), ddt, dieldrin and other organochlorines used as biocides and compounds used in industry such as polyvinyl chloride. cfcs, by harming the stratospheric ozone layer, clearly impinge on an earth system function (and thus indirectly on human environmental health); the destruction of the stratospheric ozone layer causes uv light to reach the earth's surface to a greater extent than prior to the widespread use of cfcs, leading to the potential for an increased incidence of skin cancer, ocular problems and immunosuppression. here, however, we focus mainly on the biological effects of novel entities. novel entities are not confined to new chemical compounds, as the pb authors note. genetically altered organisms can be conceptualized as novel entities, as are nanoparticles (such as in sunscreens and cosmetics), and blue light from computer and phone screens. humans are also exposed to numerous other emerging environmental hazards, especially since world war ii, and to human-generated ionizing radiation (x-rays were once routinely used to help fit shoes). possible health risks of nonionizing radiation, such as from mobile phones, are discussed briefly below, as are novel behaviors, foods and other novel environments. a lancet commission report estimates that , compounds have been synthesized since , with perhaps widely disseminated in the global environment. although some are regulated, and a few have been banned, the pace of their introduction greatly exceeds that of epidemiological investigation and legal constraint. for example, the international agency for research into cancer (iarc), which is closely affiliated with the world health organization (who) has recently concluded that the widely applied herbicide glyphosate (commercially known as "round up") may be carcinogenic. these findings have been resisted by some companies and their agents and supporters. thousands of studies of novel entities have found or suggested that many are carcinogenic, while others act as endocrine disruptors or harm health in other ways. some have been linked with massive ecosystem disruption, including colony collapse disorder (of bees) and "insectageddon." the lancet commission on pollution reported that fewer than half of the most widely dispersed chemicals have undergone any testing for safety or toxicity. interactions between such chemicals have received even less examination. the immunological and allergenic effects of most novel entities are also barely explored, and could contribute to the changing pattern of allergic diseases, auto-immune conditions and autism. while some novel entities have been regulated (e.g., x-rays) and banned (such as the "dirty dozen," including the organochlorine dieldrin, which was, as a rare exception, strongly linked with breast cancer), hundreds or thousands of others are released annually onto the market. in both industrial and rural societies, almost the entire population has been exposed to hundreds of chemicals whose concentrations can be measured in tissue samples, while for thousands more, no test exists. there is little support from policy decision makers around the world for precautionary approaches to many potential risks. for example, there are concerns that mobile phones can cause brain tissue to warm up, if the receiver is held close to the ear. however, there are also concerns about the effects of non-ionizing radiation on brain tissue, and claims of an increased risk of malignant brain tumors in heavy users of mobile phones. cardiac and neurological disorders are also plausible consequences of the rapidly increasing use of wireless devices, including smart meters. infrasound from wind turbines is another novel entity. such sounds disturb the sleep of many people who live close to them, and there may also be other harmful effects including vertigo, as well as chronic diseases worsened by chronic poor sleep. such concerns have often been dismissed as "nocebic" (i.e., through apprehension and negative thoughts) as high quality evidence for health impacts is lacking. the precautionary principle would place the onus on industry to prove safety. novel behaviors, foods, organisms and environments are also emerging in the anthropocene. examples include reduced weight bearing exercise in childhood and adolescence (leading to a higher risk of early-onset osteoporosis), increased screen watching and the partial replacement of tangible, local friends and acquaintances for virtual social networks. novel diets include the widespread consumption of sweetened drinks, a known factor in obesity and harmful to health, while the greater variety of foods out of season, especially of fruit, is beneficial. there are also novel microbial and parasitic environments and novel microbiomes, each of which is likely to be associated with health benefits and risks. for example, humans and livestock farming provide opportunity for the amplification and spread of genes that convey antibiotic resistance. these genes are favored wherever antibiotics are used by humans or fed to livestock to promote growth and limit infectious disease. antibiotic resistance genes have been shown to spread to environmental microbes in soil and water systems, to wildlife and to human and livestock pathogens. identified mechanisms for this transfer include air-borne transport of particulate matter and direct and indirect contact with waste products. the augmented "wild" population of antibiotic resistant genes is an added risk to human health and has poorly understood implications for other environmental microbial systems. novel or increased contact with mammalian wildlife creates further potential for interspecies transfer of pathogens, particularly viruses. this is discussed below (in biodiversity and health). since the s, there has been increasing recognition of ways that anthropogenic emissions of greenhouse gases (manifest in phenomena including global warming, weather wilding, jetstream oscillations, sea level rise and ocean acidification) is likely to impact human health, both positively (e.g., fewer cold waves in some areas) and negatively. there are numerous mechanisms for this. one that is perhaps most obvious is an intensification of extreme weather events, including heatwaves, droughts, flooding, and major storms including cyclones, typhoons and hurricanes. such events can have complex and delayed effects, such as from the savage hurricanes that flooded and devastated houston, texas and the us territory of puerto rico, as well as other regions. there is also speculation that the frequency, severity and locations of tornadoes may be affected. very intense flooding events, where weather systems remain almost stationary, have generated the neologism "rainbomb." changes in vector-borne diseases, food security, and sea level rise have long been forecast to occur due to global warming. global warming is already affecting migration, conflict and mental health, and these effects are likely to intensify. over the longer timescale, of decades to centuries, adverse effects are forecast to exceed benefits, perhaps by orders of magnitude, especially if the ice sheets in greenland and antarctica continue to melt. there are many ways health effects related to climate change can be categorized, such as through changes in temperature and humidity, vector ecology, water quality, water and food supply impacts, severe weather effects, air pollution, allergens, and migration, conflict and related mental health implications. a simpler classification has three main classes, conceptualized as "direct" (e.g., heatwaves), "indirect" (e.g., changes in vector ecology) and a third category, causally more displaced, with the potential for the largest burden of disease, through means such as large-scale conflict, migration and famine. in this classification, effects on mental health are regarded as "cross-cutting." dislocation from one's home due to a storm surge or a prolonged blackout (some parts of puerto rico lacked power for months following hurricane irma) can lead to depression and even suicide. such stress is also likely to exacerbate domestic violence, especially if associated with increased economic insecurity. increased rates of post-traumatic stress and anxiety are also likely in survivors. even worse than the mental trauma of a single extreme weather event are the health consequences, including to mental health, from conflict, famine and forced migration. of course, such "tertiary" effects have multi-dimensional causes, from ancient rivalries to recent and emerging contests over scarce resources, often aggravated by "youth bulges" and brutal repression. all writers on these "tertiary" topics, publishing in the academic literature, recognize the complexity of this issue, and frequently try to convey this by using the term "risk multiplier" to indicate how changes in climate can worsen (or in some cases reduce) the co-factorial causal contributors to conflict. that is, climate change is conceptualized as similar to a catalyst or enzyme. famines, wars and migration can all occur without climate change, but in some cases climate change can make these phenomena much worse. in some cases, such as sea level rise, climate change can be conceived as by far the dominant factor. however, even for vulnerable lowlying pacific islands, co-factors such as high population growth have contributed to vulnerability and the risk of migration, for example by depleting fresh water lenses, leading to the salinization of garden soil. many important diseases, including parasitic, vector-borne and zoonotic diseases are associated with invertebrates such as ticks, mosquitoes and blackflies, or higher order vertebrates. ticks transmit diseases such as lyme disease, mosquitoes transmit many illnesses such as malaria and yellow fever, while black flies transmit river blindness (onchocerciasis). the distribution of these insects and animals are shaped, not only by climate but by many other aspects of their ecology. often, the identification of the precise attribution to climate change is elusive and possibly fruitless. less intuitively, the epidemiology of many vector-borne diseases, including malaria, dengue fever and zika virus is also influenced by the ambient temperature in another way, by determining the growth rate of the parasite or virus within the cold-blooded vector. more rapid growth of these pathogens (i.e., in slightly warmer vectors) can, in some cases, lead to additional cycles of transmission, leading to explosive increases in cases. another way to think of these organisms is that their numbers and disease potential exist within a window or "sleeve" of climate and ecological suitability. it would be wrong to think that a warmer or wetter climate will inevitably increase the burden of these infectious diseases. as temperatures rise, insect populations may too, but only to a point. beyond that point, vector populations may in fact decline. similarly, excessive rain may reduce vector habitat (e.g., flushing the population away), as may unusually prolonged droughts (drying out the habitat). however, the epidemiology of vector-borne diseases is also influenced by human factors, such as insecticides (including impregnated bednets) and molluscicides, and by treatments such as vaccines (e.g., for yellow fever) and antimalarial drugs such as quinine. the impact of biodiversity loss on human health is being realized slowly. the dimensions of biodiversity (the diversity of genes, species and ecosystems) are not experienced or understood by most individuals, or policy makers, and challenge health researchers. as such, the impacts are dispersed across multiple scales of biodiversity and multiple dimensions of health and wellbeing much of which is discussed elsewhere in this contribution. the pb team has examined the genetic diversity within and between species and ecosystems and its functional role within a global system, separately. they conclude that the loss of genetic diversity has exceeded a safe limit, with uncertainty remaining over how this impacts the function of ecosystems. the alarming rate and extent of loss of genetic biological diversity has been discussed earlier. the loss of genetic diversity undermines the resilience of ecosystems. under relentless ecological change, biological diversity is replaced by ecosystems dominated by fewer, highly adaptive species, inadvertently or purposefully promoted by human activities. these include domestic species, pests and wild synanthropes, humans and the novel entities described above. genetic diversity is also the source of pharmaceutical discovery as well as the storehouse of traditional medicines. most naturederived pharmaceuticals come from plants; some come from traditional medicine practice but much is the product of systematic searching, modification and trial. nature produces an inspirational variety and complexity of molecules to further manipulate. the diverse origins of the pharmaceutical armory against hiv aids includes betulinic acid, derived from the bark of the tree betula pubescens; bevirimat, extracted from a chinese herb syzygium claviflorum; and ganoderic acid b, isolated from the fruiting bodies and spores of the fungi ganoderma lucidum. such a utilitarian appreciation likewise extends to livelihoods dependent on different aspects of biodiversity. for some, particularly vulnerable groups and those in remote locations, survival is dependent on the ability to harvest freely (or illegally) from the natural environment. rich biological diversity is often helpful for the resilience of ecosystems functions, sometimes called "services." in the early s, the millennium ecosystem assessment, a global collaboration of over scientists, grouped these into four kinds, which they called supporting, provisioning, regulating and cultural. food production is classified as a provisioning service. for such a service, biological diversity is required for (supporting or underpinning) soil health, pest control (a regulating service), pollination and the genetics of livestock and crops. other products of provisioning services include clean water, bio-fuels and crop residues used to provide energy. other regulating services include carbon sequestration, climate regulation and disaster risk reduction. nutrient recycling is another example of a supporting ecosystem service. a sacred grove or an iconic species of deep significance to the beholder illustrate cultural services. disease-regulation as an ecosystem service is contested, but some diseases, such as lyme disease, are more prevalent in diminished and simplified ecosystems. the net effect of deforestation often favors mosquitoes that serve as vectors of human diseases including previously obscure pathogens such as zika and chikungunya viruses, or encourages urbanization or farm-foraging by fruit bat hosts of henipah viruses nipah and hendra. there is also a complex relationship between ecological change and malaria, which is, by far, the most important mosquito-transmitted disease. as discussed above, climate change also impacts these vector borne diseases. changes (driven by reductions) in biodiversity have increased zoonotic infectious disease risk especially due to intensive animal husbandry. livestock, which now dominate global vertebrate biomass, and intensive production, create the opportunity for viral amplification and mutations resulting in new and previously unrecognized animal diseases and zoonoses. these include h n (avian flu, via chickens), h n (swine flu, via chickens and pigs), possibly sudden acute respiratory syndrome (sars, via farmed civet cats and racoon dogs), nipah virus in malaysia (via pigs) and middle east respiratory syndrome (mers, via camels). novel or increased contact with mammalian wildlife creates further potential for interspecies transfer of pathogens, particularly viruses. such contact is facilitated by accelerated land-use change and wildlife harvesting and sometimes aided by domestic animals acting as amplification hosts. disease may transmit directly to humans or indirectly through domestic animals. many opportunities for viruses to jump between species may be required before a significant disease emerges. tropical areas of high biodiversity and under human pressure are considered "hotspots" for such diseases. novel zoonoses of wildlife origin such as hiv aids, ebola and sars corona virus have been the subject of strong interest in the late th century and early st century. the examples above have resulted in pandemics. many other smaller viral "spillover" events have occurred with localized impact only. natural or wild areas also reduce stress, depression and anxiety in those who visit them. this effect appears to be dependent on cultural and socioeconomic characteristics of the visitor and has deeper, religious dimensions for many indigenous people. as discussed earlier, the human microbiome links us to the external world. personal microbiodiversity is enriched by environmental and dietary diversity and, through mechanisms of immune regulation and the gut-brain axis, has a significant impact on physical and mental health. the benefits of experiencing biodiversity within natural settings appear to be physiological as well as psychological. however, the living environs of most people is one of reduced biodiversity, and for many most time is spent indoors. it is the capacity of earth's natural systems, the aggregate of species and ecosystem biodiversity, to provide resilience despite changing environmental conditions that should be of the most fundamental concern to health and well-being. the biosphere must absorb our wastes, including carbon emissions; buffer coastlines from extreme weather events; provide clean air, water, a moderate climate, and the renewable resources humanity seeks to consume. it is therefore of great concern that the global ecological footprint network (see "the ecological footprint" section) estimates that % of [global] biocapacity is consumed per annum. today, many determinants of health and wellbeing, including effective health services and their inputs, such as consumables and pharmaceuticals, are dependent on abundant and affordable energy. millions of people living in poverty, especially in sub-saharan africa and south asia, suffer multi-system consequences of air pollution, both indoor and outdoor, from smoke generated by their own household and by other households. in many locations, this is aggravated by the burning of fossil fuels such as coal and oil. many people, particularly women and children, undertake daily laborious effort to obtain fuel and water. access to electrical power, and even gas for cooking would bring significant improvements in health to the . billion people living without electricity. probably the least understood aspect of limits to growth is the concept and importance of declining energy return on energy investment (eroei). the number given for eroei is the ratio of useful energy obtained versus primary energy expended (see box ). the major energy carriers in use today are fossil fuels, especially coal, oil and gas. these are used not only for transport, heating and electrical power (over % globally), but also as a chemical stock to manufacture plastics and to make fertilizer. but, just as in the past when our ancestors bred, trained, housed and fed donkeys and draft horses for assistance with laborious tasks, fossil fuel needs to be wrested from the environment, whether drilled for, dug by hand or removed by robotic shovels. these processes themselves take energy. in addition, energy released or captured from these sources needs to be distributed and the infrastructure to do that needs to be maintained. coal needs to be transported and burned, with some of its energy captured through combustion. electrical energy needs to be distributed and regulated irrespective of its source (including solar, wind, hydro and tidal). to manufacture wind turbines or solar panels requires energy, as does the mining infrastructure described above. life-cycle assessment allows a full quantification of the energy invested in any form of energy extracted, which is clearly significant. in the heyday of fossil fuels, oil and coal were easy to extract, and their eroei was highdsome analysts report an average eroei of over in the late th century. in contrast, a review published in in nature communications found that, globally, up until , solar panels may have yielded no energy beyond that required for their manufacture and installation. in other words, under the least optimistic scenario, solar panels, cumulatively, have been a sink for energy, rather than a source until very recently. more encouragingly, the eroei for solar appears to have increased considerably in the last decade, perhaps to or , especially in locations with high insolation, such as in the tropics. the climate footprint of solar is much lower than of coal and will continue to decline, especially as the efficiency of panels increases and the electricity they generate is used to manufacture additional ones. the eroei for wind is widely agreed to be even higher than for solar, so these two sources have promise as major substitutes for fossil fuel energy, even though researchers still debate whether renewables will yield energy abundant enough to fuel the current consumption-oriented economy. in addition, ugo bardi and sgouris sgouridis argue that the window for a successful transition is narrow: a very large investment of available energy is required, while still maintaining adequate energy for ongoing services. moreover, the world's economic system may fail to allocate the necessary resources in the necessary timeframe (by in this analysis). bardi and sgouridis are skeptical that market forces can effect this transition. they calculated that, as of , capital investment is only about one tenth of what is required. energy investment is also inadequate. though not impossible, any transition to renewables will be challenging and requires a substantially greater rate of energy and capital investment than is currently allocated. there is a widespread understanding that fossil fuels have been crucial to the human colonization and domination of the biosphere. the importance of energy is explicit in the work of many environmental writers, and implicit in the military actions of many great powers, who have frequently acted with violence or duplicity to acquire or maintain energy resources, from the middle east to the timor sea. without fossil fuel, modern civilization could not have evolved in the way it did, whether to create highways, intensive agriculture, skyscrapers or the space age. although, in the middle ages, the harnessing of water power for work from milling grain to sawing wood ("sawmilling") was widespread, such industry was necessarily confined to suitable riversides. ancient mariners crossed straits and sometimes oceans, powered by oars and blown by the wind, but the scale of maritime trade was miniscule compared with that made possible by steam, oil and nuclear-powered vessels. while this dependence on energy is well-known, though rarely highlighted in economic histories, the fact that eroei is steadily declining is rarely mentioned in mainstream media or outside of specialist journals; it is claimed that fracking and shale oil now negate peak oil, though insufficient attention is paid to the instability of an industry reliant on proliferation of drilling sites and rising costs. the decline of eroei may be disconcerting to a public ill-prepared for the future austerity which such a decline implies. such consequences would not only affect health services, but the myriad other processes necessary for health which rely on affordable energy, including agriculture. concern about the impact of global ecological change on health is growing. so too is an understanding of the need for multi-sector collaborations. few groups are yet addressing the deeper issues of pbs. however, many once disparate groups are converging as they seek to improve equity in health with a focus on global problems of biodiversity decline, environmental degradation and climate change. "planetary health," promoted by the prestigious medical journal the lancet, is currently prominent. others include eco-health, one health and the in vivo planetary health group. predicting future human health (or survival) under the status quo is difficult. ecological systems typically demonstrate nonlinear responses to perturbations and it is likely that current consumption patterns will precipitate dramatic shifts in biodiversity, ecological function and health-supporting services. impacts of environmental change are disproportionately experienced by poor and rural communities. advocacy and action to prevent these health risks is an essential role for those concerned with public health. this entry has reviewed the issue of limits to growth, its more modern formulation as planetary boundaries and the relevance of both concepts to global population health. it has used these frameworks to classify and extend some environmental health risks. these include novel entities and behaviors, and global risks including climate change, biodiversity loss, land-system change and biogeochemical cycles. these risks are escalating and we recognize the shortfall in assessing the health risk of new pollutants, entities and behaviors. when considered together with economic and population growth, and with ever-increasing resource and energy use, these environmental health risks may foreshadow significant population decline. by using the ltg and pb frameworks in this contribution, society can frame preventative measures on the scale at which this is required. without urgent change, future global population health, and survival, is imperiled. environmental quality in a growing economy. resources for the future health, population, limits and the decline of nature climate change, food security and population health in the anthropocene a further critique of growth economics encyclical letter laudato si of the holy father francis on care for our common home collision course: endless growth on a finite planet the limits to growth great transition: the promise and lure of the times ahead union of concerned scientists, . world scientists' warning to humanity the interaction of human population, food production, and biodiversity protection is global collapse imminent? re-assessment of net energy production and greenhouse gas emissions avoidance after years of photovoltaics development come on! capitalism, short-termism, population and the destruction of the planet understanding social-ecological systems fischer: a critical look at food security strategies key: cord- -unoeicq authors: teshome, abinet; glagn, mustefa; shegaze, mulugeta; tekabe, beemnet; getie, asmare; assefa, genet; getahun, dinkalem; kanko, tesfaye; getachew, tamiru; yenesew, nuhamin; temtmie, zebene; tolosie, kabtamu title: generalized anxiety disorder and its associated factors among health care workers fighting covid- in southern ethiopia date: - - journal: psychol res behav manag doi: . /prbm.s sha: doc_id: cord_uid: unoeicq background: healthcare workers (hcws) are among the many groups of people who are in the frontline caring for people and facing heavy workloads, life-or-death decisions, risk of infection, and have been facing various psychosocial problems. so, monitoring mental health issues to understand the mediating factors and inform evidence-based interventions in a timely fashion is vital. purpose: this study aimed to assess generalized anxiety disorder and its associated factors among hcws fighting covid- in southern ethiopia. patients and methods: an institution-based cross-sectional study was conducted among hcws from may to june . a pre-tested and structured interviewer-administered kobo collect survey tool was used to collect data. the study participants were selected using a simple random sampling technique by allocating a proportion to each health institute. the association between the level of generalized anxiety disorder and its independent variables was examined by ordinal logistic regression. assumptions for the proportional odds model were checked using parallel line tests. an adjusted proportional odds ratio with a % ci was used to calculate the strength of the statistical association between the independent and dependent variables. results: the prevalence of mild and moderate anxiety disorder among hcws was . % and . %, respectively. contact with confirmed or suspected cases (apor = . ; % ci: . , . ), no covid- updates (apor= . , % ci= . , . ), no confidence on coping with stresses (apor= . , % ci= . , . ), and covid- -related worry (apor= . , % ci= . , . ) were positively associated with higher-order anxiety disorder. however, not feeling overwhelmed by the demands of everyday life (apor= . , % ci= . , . ) and feeling cannot make it (apor= . , % ci= . , . ) were negatively associated with a higher order of anxiety. conclusion: the study revealed that the prevalence of anxiety disorder among hcws was high in the study area. the findings of the current study suggest immediate psychological intervention for health care workers in the study area is vital. therefore, proactive measures should be taken by the stakeholders at different hierarchies to promote the psychological wellbeing of hcws in order to control the impact of the pandemic on the hcws, and containing the pandemic. health care workers (hcws) who are in the frontline caring for people with covid- infection have been facing various psychosocial problems, including a high risk of infection and inadequate protection from contamination, overwork, frustration, a lack of contact with their families, and loved ones. the severe situation is causing mental health problems such as anxiety. [ ] [ ] [ ] generalized anxiety disorder is the most frequently occurring mental health disorder, which is characterized by excessive worry or fearfulness about events and is associated with heightened tension, nervousness, and irritability; it may cause physical symptoms such as restlessness, fatigue, muscle stiffness, and trouble concentrating or sleeping. , the hcws are facing the pressure of working in resource-deprived settings and ever-growing patient load all over the world. according to the studies conducted in the era of severe acute respiratory syndrome (sars) and ebola epidemics, the onset of a sudden and immediately lifethreatening illness could lead to extraordinary amounts of pressure on hcws and might cause adverse psychological disorders, such as anxiety, fear, and stigmatization. [ ] [ ] [ ] [ ] the other study conducted in italy reported a significant proportion of hcws experienced anxiety, depression and sleep disturbances during this psychological pressure exerts an adverse effect on the quality of care given for patients. hcws are expected to wear heavy protective garments and other personal protective equipment during pandemic like covid- , making it much more difficult to carry out medical operations or procedures than under normal conditions. these factors, together with the fear of being contagious and infecting others, physical exhaustion, inadequate personal equipment, and the need to make ethically difficult decisions on the rationing of care could increase the possibility of psychological issues among hcws. , - a study conducted in china reported that % of hcws experienced anxiety during the fight against covid- . another study conducted on the psychological impact of the covid- pandemic on health care workers in singapore reported a . % anxiety prevalence. besides, a hong kong study found that health workers suffered high anxiety scores after directly treating confirmed sars patients. studies revealed that having comorbidities, living in the rural areas, being a female health worker, marital status, profession, having children, and contact with covid- patients were the most common risk factors for developing anxiety among health workers. , ethiopia faces the most critical phase of the pandemic, with community transmission. hcws across the country are facing a fight like never before. frontline health-care workers, faced with heavy workloads, life-or-death decisions, and risk of infection, are particularly affected. even though there are some studies conducted on the psychosocial impact of covid- and its associated factors globally, it is a new disease and the medical system and culture of different countries vary which necessitates the need for further research on the psychological experience of frontline health workers fighting against covid- . currently, as far as our literature search is concerned, there are no published studies on anxiety related to covid- in ethiopia in general and southern region in particular. therefore, this study aimed to assess generalized anxiety disorder and its associated factors among healthcare workers fighting covid- in southern ethiopia. the findings of this study are timely and would help the local program planners and policymakers to plan appropriate interventions at the early stage to prevent a detrimental psychological outcome of hcws. institution-based cross-sectional study was conducted among health workers working in gamo, gofa, konso, and south omo zones of southern ethiopia from , may to , june . there are a total of two general and primary hospitals, and health centers in the four zones. there are health professionals providing health services in the zones. all health care workers working in four zones during the data collection period were included in the study. a single population proportion formula ((zα/ ) pq/d ) was used to estimate the sample size required for the study. the sample size calculation assumed the proportion (p), the estimated level of anxiety among hcws was estimated to be % because there is no prior study finding in ethiopia, % confidence level, margin of error of %, and a design effect of which gave the sample size of . in consideration of a % non-response rate, the final sample size was hcws. mathematically, it is calculated as follows: z= the standard score corresponding % confidence interval ( . ) p= level of anxiety among hcws, it was estimated to be % d= margin of error, % by considering a design effect of because we used a multi-stage sampling technique ( * = ). then, we considered a % non-response rate, the final sample size used for this study was + = . the study participants were selected using a multistage sampling technique. first, % of health institutions were selected using a simple random sampling technique (computer-generated random numbers) after allocating a proportion to each zone based on the size of health institutions. then, the sample size was proportionally allocated to the health institutes based on the size of health care workers. lists of active health care workers were taken from each selected health institute. finally, a simple random sampling technique (computergenerated random number) was implemented to recruit the health professionals in each selected health institute. a pretested and structured interviewer-administered questionnaire was used to collect data. the tools were developed by reviewing different works of literature and the world health organization (who) guidelines. the survey questionnaire included socio-demographic characteristics, medical history, alcohol use, physical exercise, and miscellaneous psychosocial questions. generalized anxiety disorder scale (gad- ) was used to assess the level of anxiety among health professionals. it is a -item questionnaire developed to screen patients for anxiety and rate the severity of anxiety. each item is rated on a -point likert-scale ranging from (not at all) to (nearly every day) on the symptoms in the previous weeks. the total score of gad- ranged from to , with increasing scores indicated more severe functional impairments as a result of anxiety. for the purpose of this study, the score of anxiety assessing questions was calculated for each respondent then the overall score was computed and the levels of anxiety were classified into none to minimal, mild, moderate, and severe. scores represent - none to minimal, - mild, - moderate, and - severe anxiety. during data collection, a reliability analysis was done and the result showed a good score of internal consistency between the items (cronbach's alpha = . ). language experts translated the questionnaire from english to amharic and back to english to ensure consistency in meaning. a pretest was conducted on an unselected health institute by taking % of the total sample size. after we made appropriate corrections, the revised version of the questionnaire was used for final data collection. twelve trained public health professionals participated in the data collection. we used kobo collect survey tool to collect data. kobo collect survey tool is mobile applications that allow for the collection of data using mobile devices, analysis of data, and storage of data -either online or offline. data were collected using face-to-face data collection technique. all who recommended covid- protective measures were applied during the data collection period. data collectors and supervisors were provided with intensive training on the techniques of data collection and components of the instrument. before the commencement of the data collection, a pretest was conducted. a standard tool, which was developed by experts, was used to collect the information. the kobo collect survey tool that was very important to control the quality of data was used to collect data by using tablets. the authors and supervisors critically checked the data for completeness before being uploaded to the kobo collect cloud server. the collected data were downloaded from the kobo collect. it was then edited and cleaned for inconsistencies, missing values using excel, and then exported to spss version (spss inc., chicago, il, usa) for further analysis. descriptive statistics were computed and summarized in tables, figures, and text with frequencies, mean, or standard deviations where appropriate. the association between the level of generalized anxiety disorder and its independent variables was examined by ordinal logistic regression. the ordinal logistic regression model was used because the level of anxiety was determined by using ordinal data (none to minimal, mild, moderate, and severe). the proportional odds model (pom) was fitted to identify factors associated with the level of generalized anxiety disorder. the necessary assumptions for pom were checked using parallel line tests. the psychology research and behavior management : submit your manuscript | www.dovepress.com dovepress chi-squared test (χ ) for the proportional odds assumption was calculated to see whether the model assumptions were violated or not. the pearson χ goodness-of-fit test showed that the observed data were consistent with the fitted model; the deviance test (χ = . , p = . ) was non-significant. additionally, the appropriateness of the pom was calculated by the parallel line test, and it showed that the general model did not significantly differ from the fitted pom (p= . ), this indicated that the model fit the data well. furthermore, the χ test of parallelism showed that the odds ratios were constant across all cutoff points of anxiety level for the final model at a % level of significance. bivariable analyses were performed between the dependent and independent variables. all variables with a p -value < . in the bivariable analysis were fitted into the multivariable pom to control for confounding effects. an adjusted proportional odds ratio with a % ci was used to calculate the strength of the statistical association between the independent and dependent variables. ethical approval and clearance were obtained from arba minch university institutional research ethics review board, college of medicine and health sciences with reference number (irb/ / ). a letter of cooperation was obtained from the zonal health department and health institutes of the respective zones. the purpose of the study was explained and informed written consent was taken from each health care worker. to ensure confidentiality, their names, and other personal identifiers were not registered in the survey tool. besides, this study was conducted in accordance with the declaration of helsinki, and all ethical and professional considerations were followed throughout the study to keep participants' data strictly confidential. the data were collected from study participants with a . % response rate. out of the total respondents, ( . %) were male. the mean age (± sd) of the participants was . years (± . ) years. the majority of the participants were town residents ( . %) and more than half of the participants were protestant religion followers ( . ). among the participants' health workers, ( . %) were clinical nurses and ( . %) were diploma holders (table ) . among the respondents, % of them reported no adequate personal protective equipment in their health institute. the majority of the participants ( %) had access to media. of respondents, ( %) had no confidence in coping with stress-related with covid- , ( . %) had a feeling of susceptibility, and ( . %) had covid- related worries. among the participants, ( . %) believed that the suggested prevention and control practices can contain the pandemic (table ) . among health care workers who participated in this study, . %, . %, . % and . % of them believed the community members were responding to the prevention practice of covid- , not at all, somewhat, moderately, and to the great extent, respectively. more than two-thirds ( . %) of hcws felt valued by their families. the data revealed that from the participant health care workers, . %, . %, . % and . % of them agreed the government is supporting the prevention and control of covid- , not at all, somewhat, moderately, and to the great extent, respectively. the prevalence of mild and moderate anxiety disorder among hcws was . % and . %, respectively. there was no severe stage of anxiety observed during the data collection period (figure ). in ordinal logistic regression analysis, variables such as contact with confirmed or suspected cases, covid- updates, confidence in coping with stresses, covid- related worries, feel overwhelmed by the demands of everyday life, and feeling cannot make it were statistically significantly associated with an anxiety disorder. the risk of being in the higher order of anxiety was almost two times (apor = . ; % ci: . , . ) higher among health professionals who had contact with confirmed or suspected covid- cases compared to who had no submit your manuscript | www.dovepress.com psychology research and behavior management : contact. likewise, health care professionals who had no covid- update were almost times (apor= . , % ci= . , . ) more likely to develop a higher order of anxiety than those hcws who had an update. similarly, hcws who were somewhat confident in coping with stress were . times (apor= . , % ci= . , . ) more likely to develop a higher order of anxiety disorder than their counterparts. regarding covid- related worries, the odds of health care workers who had covid- related worries were . times (apor= . , % ci= . , . ) more likely to experience higher order of anxiety than who did not worry. the odds of health care workers who had not felt overwhelmed by the demands of everyday life were % (apor= . , % ci= . , . ) less likely to develop a higher order of anxiety than who was feeling overwhelmed. similarly, the odds of health care professionals who did not feel that they cannot make it were also % (apor= . , % ci= . , . ) less likely to experience higher order of anxiety than who felt they can make it (table ). the study examined the prevalence of anxiety among health care workers and identified risk factors for increased anxiety. the finding of this study revealed that . % and . % of hcws suffered from mild and moderate anxiety disorder, respectively. a study from china reported that . % of the hcws had symptoms of anxiety. a related study conducted in turkey indicated that . % of respondents had anxiety-related symptoms. of this, . , . %, . %, and . %, of hcws had mild, moderate, severe, and extremely severe anxiety symptoms, respectively. another recent meta-analysis of studies reported the prevalence rate of the anxiety of hcws during covid- was ranging between . %- . %. pockets of studies from different corners of the world had been reported the prevalence of anxiety among hcws with a range of . % , - and finding of the present study was within this reported range. the finding of the current study showed that the majority of the hcws experienced mild symptoms of anxiety, while moderate and severe symptoms were less common among the participants. in our view the reported figure is huge since the study was conducted at the early stage of the pandemic in ethiopia; this alarms the need for early detection and the importance of picking up and effectively treating the milder clinical symptoms of anxiety dovepress before they evolve to more complex psychological disorders. furthermore, a lower moderate and severe level of anxiety might be associated with the lower report of confirmed cases due to limited testing capacity during the study period in comparison with other countries. there was also a lower report of confirmed cases in the study area. a study from china which was the epicenter of covid- showed that working outside the epicenter was associated with a lower risk of psychological symptoms than working in the epicenter even in the same country. however, mild anxiety symptoms were higher among hcws in the study area. this high level of anxiety among the hcws in our study area could be attributed to fear of transmission of the disease to their family, no updates on covid- -related issues especially hcws working in a rural area with no mobile network and internet connection, lack of specific drugs treating covid- patients, an increasing number of suspected and confirmed cases and inadequate personal protective gears. eighty-five percent of the participants perceived that personal protective equipment was inadequate in their health institutions. the difference in the prevalence of anxiety in different parts of the world could be attributed to variations in the health system characteristics, the culture of patient care, technologies, availability of ppe, and the tool used to assess anxiety and heterogeneity in cut off points. in the present study, we used the standard and validated tool developed for measuring generalized anxiety disorder after we checked its validity and reliability in our context. authorities at different hierarchies should assess the hazards to which their health care workers are exposed; evaluate the risk of exposure; and select, implement, and ensure workers use controls to prevent exposure to the virus. occupational health surveillance has paramount importance to enhance the wellbeing of hcws. such type of study is helpful for different stakeholders to monitor mental health issues to understand the mediating factors and inform evidence-based interventions in a timely fashion. , our study further indicated that health professionals who had contact with confirmed or suspected covid- cases were two times more likely to develop a higher order of anxiety than those who had no contact. the finding of this study was consistent with the studies conducted in china, , the score of anxiety increases among health care workers having direct contact with suspected and confirmed cases. this can be reasoned out that contact with suspected or confirmed cases increases the risk of transmission and exposure. the health workers working in low resource settings (weak health system, low economic status, and poor technology) like ethiopia may limit their ability to follow the recommended measures; these and other factors exacerbate the fear of hcws. although the ethiopian government and people presented recognition for hcws for their dedication in fighting covid- which could make health workers feel honored and proud to participate in this difficult assignment -the local and national authorities should also focus on implementing measures targeting the psychological well-being of hcws. likewise, health care professionals who had no covid- update were almost times more likely to develop a higher order of anxiety than those health care professionals who had an update. this can be explained by hcws getting information on the route of transmission, the availability and effectiveness of medicines/vaccines, experience in handling covid- patient, the number of infected cases and locations, and advice on prevention of the covid- increase the confidence of hcws otherwise working in an uncertain environment without up to date information might worsen anxiety. this finding was also in agreement with the study conducted in china. the odds of health care professionals who had covid- related worry were more likely to experience higher order of anxiety than those health care workers who did not worry. this might be justified as health care workers are working in a highly risky environment so that increases the probability of being infected so that they might worry about transmitting the infection to their families and loved ones, separating with their children, and being stigmatized. the finding was also supported by other studies; , respondents were very worried or somewhat worried about other family members getting covid- . furthermore, personal protective equipment, such as surgical masks face mask, eye goggles, protective clothing, gloves, and sanitizers, were severely deficient during the early stages of the outbreak in ethiopia which might exacerbate worries of health care workers. overwhelmed by daily activities and cannot make it were also significantly associated with developing higher order of anxiety among hcws. this might be due to work overload, inner conflict about competing needs and demands of hcws, stigma, and fear of being removed from their duties during a crisis heighten anxiety. this study has some limitations which have to be taken into consideration while interpreting the findings. as being crosssectional in the design, it does not confirm the definitive cause and effect relationship. we were unable to differentiate the preexisting anxiety from the new cases of anxiety. the other limitation of the study might be social desirability bias but we tried to minimize it by reminding participants about confidentiality and anonymity during data collection. however, the current study had strength; to the best of our knowledge, this is the first study assessed the prevalence of anxiety among hcws during covid- in ethiopia, we used a strong method of analysis (ordinal logistic regression), a validated and standardized tool with an appropriate cut off points to the study revealed that the prevalence of anxiety disorder among health care workers was high in the study area. covid- updates, contact with confirmed or suspected cases, confidence in coping with stresses, covid- related worry, feel overwhelmed by the demands of everyday life, and feeling cannot make it were significant factors associated with the higher order of anxiety. the findings of the current study suggest immediate psychological intervention for health care workers in the study area is vital. therefore, proactive measures should be taken by the stakeholders at different hierarchies to promote the psychological wellbeing of hcws in order to control the impact of the pandemic on the hcws, and containing the pandemic. tribute to healthcare operators threatened by covid- pandemic adjustment process during epidemics of covid- and mental health the covid- pandemic, personal reflections on editorial responsibility national institute for health and care excellence epidemiology of anxiety disorders in the australian general population: findings of the australian national survey of mental health and wellbeing mental health of medical workers in pakistan during the pandemic covid- outbreak depression after exposure to stressful events: lessons learned from the severe acute respiratory syndrome epidemic immediate and sustained psychological impact of an emerging infectious disease outbreak on health care workers mental distress among liberian medical staff working at the china ebola treatment 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factors associated with mental health outcomes among health care workers exposed to coronavirus disease depression, anxiety, stress levels of physicians and associated factors in covid- pandemics prevalence of depression, anxiety, and insomnia among healthcare workers during the covid- pandemic: a systematic review and meta-analysis prevalence and influencing factors of anxiety and depression symptoms in the first-line medical staff fighting against covid- in gansu a multinational, multicentre study on the psychological outcomes and associated physical symptoms amongst healthcare workers during covid- outbreak psychological impact of the covid- pandemic on health care workers in singapore covid- infection in italy: an occupational injury the crucial role of occupational health surveillance for health-care workers during the covid- pandemic. workplace health saf immediate psychological responses and associated factors during the initial stage of the coronavirus disease (covid- ) epidemic among the general population in china covid- -related stress, anxiety and depression during the pandemic in a large population enriched for healthcare providers the authors are grateful for the data collectors, the study participants, and supervisors for their co-operation during data collection. our thanks also goes to arba minch university for funding and providing ethical clearance. all authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. the authors report no conflicts of interest in this work. psychology research and behavior management is an international, peer-reviewed, open access journal focusing on the science of psychology and its application in behavior management to develop improved outcomes in the clinical, educational, sports and business arenas. specific topics covered in the journal include: neuroscience, memory and decision making; behavior modification and management; clinical applications; business and sports performance management; social and developmental studies; animal studies. the manuscript management system is completely online and includes a very quick and fair peer-review system, which is all easy to use. visit http://www. dovepress.com/testimonials.php to read real quotes from published authors. key: cord- -sfbji mf authors: ilenghoven, devananthan; miswan, akmal hisham; ibrahim, salina; yussof, shah jumaat mohd title: restructuring burns management during the covid- pandemic: a malaysian experience date: - - journal: burns doi: . /j.burns. . . sha: doc_id: cord_uid: sfbji mf nan telemedicine also allowed the sharing of expert opinion and management protocols. communication via this method avoids in-person interaction, which contributes to the prevention of disease transmission. as a precaution, mitigation strategies were drawn up and implemented. the burns management team was divided into functional independent teams. direct meetings between the teams were kept to a minimum and discussions held via video conferencing, ensuring the continuity of care if one team is exposed to the covid- virus. all health care personnel implementation of these strategies has helped us to prevent covid- infection among the doctors and nurses in our department. up to now, we have zero confirmed cases of transmission of this disease to health care workers from treating covid- positive patients nationwide. this pandemic has drastically changed the way we handle burn patients. emphasis on patient and health care workers' safety is the utmost priority. it is imperative that we learn from this experience and formulate guidelines that can be adhered to for future pandemics. as long as a vaccine is not available, we need to be constantly prepared for any surge in new cases. adherence to the new norm is mandatory for us to succeed in this pandemic. of novel coronavirus-infected pneumonia guidelines covid- management in malaysia no press conference by datuk dr noor hisham abdullah, director general of health, ministry of health malaysia this short communication has obtained the permission to publish by the director-general of health, ministry of health, malaysia.j o u r n a l p r e -p r o o f key: cord- - s e authors: sun, mei; xu, ningze; li, chengyue; wu, dan; zou, jiatong; wang, ying; luo, li; yu, mingzhu; zhang, yu; wang, hua; shi, peiwu; chen, zheng; wang, jian; lu, yueliang; li, qi; wang, xinhua; bi, zhenqiang; fan, ming; fu, liping; yu, jingjin; hao, mo title: the public health emergency management system in china: trends from to date: - - journal: bmc public health doi: . /s - - - sha: doc_id: cord_uid: s e background: public health emergencies have challenged the public health emergency management systems (phemss) of many countries critically and frequently since this century. as the world’s most populated country and the second biggest economy in the world, china used to have a fragile phems; however, the government took forceful actions to build phems after the sars outbreak. after more than one decade’s efforts, we tried to assess the improvements and problems of china’s phems between and . methods: we conducted two rounds of national surveys and collected the data of the year and , including all provincial, municipal, and county cdcs. the municipal and county cdcs were selected by systematic random sampling. twenty-one indicators of four stages (preparation, readiness, response and recovery) from the national assessment criteria for cdc performance were chosen to assess the ten-year trends. results: at the preparation stage, organization, mechanisms, workforce, and stockpile across all levels and regions were significantly improved after one decade’s efforts. at the readiness stage, the capability for formulating an emergency plan was also significantly improved during the same period. at the response stage, internet-based direct reporting was . %, and coping scores were nearly full points of ten in . at the recovery stage, the capabilities were generally lower than expected. conclusions: due to forceful leadership, sounder regulations, and intensive resources, china’s phems has been improved at the preparation, readiness, and response stages; however, the recovery stage was still weak and could not meet the requirements of crisis management and preventive governance. in addition, cdcs in the western region and counties lagged behind in performance on most indicators. future priorities should include developing the recovery stage, establishing a closed feedback loop, and strengthening the capabilities of cdcs in western region and counties. since the early twenty-first century, frequently appearing public health emergencies such as severe acute respiratory syndrome (sars), middle eastern respiratory syndrome, and ebola have threatened population health and social stability [ ] . this has critically challenged the public health emergency management systems (phemss) of many countries [ ] , especially developing countries. the global community quickly reached a consensus on the development of the phemss [ ] . in , the th world health assembly (wha) adopted the revised international health regulations, which instructed the world health organization (who) member states to collaboratively confront public health emergencies of global concern. a world health report in also focused on global public health security in the twenty-first century. the ebola outbreak in - has pushed the process of who reform into high gear [ ] , giving top priority to changes in the who's emergency operations and a need to build resilient health systems that can withstand epidemics. china has the largest population and the second biggest economy in the world. china has played an increasingly important role in preventing and controlling the global spread of epidemics in recent years and gradually changed from aid recipient to aid donor [ ] . china used to have a fragile phems; however, the sars outbreak exposed many weaknesses and problems [ ] , such as an ineffective response system, lagging epidemiological field investigation and laboratory testing skills, and inaccurate and untimely information communication. these aroused the public's horror and international community's blame. the central government urged governments at different levels to make political commitments and take forceful actions to build the phems. after more than one decade's efforts, what are the trends of china's phems? what are the improvements and remaining problems? what are the implications for china and global health security? in recent years, the development of phems has received increased attention in the literatures. some researchers expressed the importance of phems and the progress after sars qualitatively [ , ] . others quantitatively accessed the trends using regional data, usually at a certain level or within a certain province or city [ ] [ ] [ ] [ ] . time spans were restricted to early-phase usually around [ ] . to our knowledge, little evidence could tell the differences that happened in china's phems in this decade. based on two national surveys in and , we previously reported that resource allocation of cdcs increased and the general completeness of phems improved between and [ ] . however, what measures phems carried out and how it changed still remained unclear. this paper will attempt to answer these questions specifically. this article consists of the follows. the next section provides details on methodology,including sampling, indicator selection and measurements, data collection, and data analysis methods. the third section shows the results, followed by discussion corresponding to the results. the final section is about conclusion and policy implications. the survey methods have previously been published [ ] . briefly, we conducted two rounds of cross-sectional surveys in and . the two surveys were retrospective and selected the same agencies in the two rounds. the survey of collected the data from to , and the survey of collected data of . we conducted a multistage sampling to select cdcs at different administration levels, selected all provincial cdcs and used systematic random sampling to select municipal and county cdcs. as governmental funding is the most critical control point of public health emergency management for the cdcs [ ] ,we used "governmental funding to cdcs per thousand people" as a basis to determine sample size [ ] . a sample size of municipal and county cdcs was calculated based on the following formula [ ] . where n is the number of the minimal sample size; αis the probability of type i error, and β is the probability of type ii error, here α = . ,β = . ; u α and u β are standard normal distribution values corresponding to α and β respectively;σis the population standard deviation, hereσ = . yuan; δ is the allowable error. for municipal cdcs, δ = . yuan, σ = . yuan. for county-level cdcs, δ = . yuan, σ = . yuan ( u.s. dollar = . yuan). the municipal and county level cdcs were all selected through random sampling. the sampling process was conducted based on the national standard coding (gb coding, the corresponding administrative regional code which is unique for each city or county [ ] ). we used a computergenerated random number to identify the first institution, and then selected every third municipal cdc and every sixth county level cdc. finally, we selected provincial cdcs, municipal cdcs, and county cdcs. the study was approved by the former ministry of health (moh) in china and reviewed by the medical research ethics committee at the school of public health of fudan university. we selected twenty-one indicators associated with the phems from the national assessment criteria for cdc performance. based on the crisis management theory which was commonly used in the field of public emergency management [ , ] , the whole process was divided into four stages including preparation, readiness, response and recovery [ ] . according to the framework, we grouped the indicators into stages and capabilities. table showed the features, units and measurements of these indicators. according to the national regulations on public health emergency management [ ] , each sampled cdc graded five public health emergencies handled in the year before the survey with the full mark of points for each indicator; at cdcs where the total numbers of handled public health emergencies were fewer than five, all public health emergencies were graded instead. the bureau of disease prevention and control of the former moh approved and organized two rounds of field surveys, and provincial health departments coordinated data collection. a pilot survey was conducted to ensure validity and reliability. after receiving uniform training from the moh, the provincial quality supervisors trained investigators from sampled cdcs in their corresponding provinces. the investigators collected relevant data from sampled cdcs and submitted the completed questionnaires to their provincial quality supervisors via e-mail or cd-rom. simultaneously, paper copies with official stamps were submitted. the second round of survey data were obtained from national disease control and prevention performance evaluation platform. the quality control process was set up and carried out by the platform with backend logic judgments and audit procedures. as the final step of quality control in both surveys, research group rechecked data and contacted cdcs with abnormal or absent values via email or phone. finally, the overall response rate was . % in and . % in . we established a dataset using excel (microsoft redmond wa). we only used the data of the year and for analysis. after data cleaning and sorting, descriptive analysis and statistical tests were performed using spss . (ibm spss, chicago, il, usa). we used establishing organization comprised building an emergency response office and forming a leadership group and an expert panel. table ). the capability for building mechanisms in terms of information sharing and on-site treatment increased by . % and . %, respectively. increasing by . %, response-material deployment mechanism gained the highest growth rate. municipal cdcs had the highest percentages, followed by provincial and county cdcs. the central region not only had the highest percentages, but also experienced the highest growth rate. average number of emergency response personnel per cdc increased from in to in , which was significant. in , provincial cdcs had the highest number of personnel (n = ), followed by municipal (n = ) and county (n = ) cdcs. moreover, the average number decreased from eastern (n = ) to western regions (n = ) ( table ). the percentage of fully stockpiling emergency resources significantly increased from . % in to . % in . provincial cdcs had the highest percentage ( . %) in and increased by . %, whereas county cdcs had the lowest percentage ( . %) in and increased by . %. nevertheless, the average percentage at each administrative level did not meet the corresponding performance assessment criteria. average percentages of fully stockpiling emergency resources decreased from eastern ( . %) to western ( . %) regions. the mean percentage of formulating emergency plan increased from . % in to . % in , statistically significantly increasing by . %. provincial cdcs had the highest percentage ( . %) in , and the difference between municipal ( . %) and county cdcs ( . %) was not significant. cdcs in central region had the highest percentage ( . %), followed by western ( . %) and eastern ( . %) regions ( table ). the average length of emergency response training increased from . days per person in to . days per person in ; however, this . % increase was not statistically significant. provincial cdcs had the highest average length of response training ( . days per person), followed by municipal and county cdcs (table ) . comparing the statistics in and , the average times of exercises did not change with statistical significance. in , county cdcs had higher average times of exercises than did municipal ( . ) and provincial ( . ) cdcs; nevertheless, only provincial cdcs had increased average times of exercises during the past decade. from regional perspective, the average times of exercises decreased from western ( . ) to eastern ( . ) regions (table ). there were . % and . % of disease surveillances conducted per month and per week in , respectively. compared with statistics in , frequencies of daily, weekly, and monthly surveillance analysis increased, among which weekly surveillance analysis increased with statistical significance. meanwhile, the frequencies of disease surveillance analysis per ten days, quarter, and year decreased with statistical significance ( table ). according to "contingency rules of paroxysmal public health events", public health emergency events are classified into four levels (i, ii, iii and iv), with severity decreasing from level i to level iv. in , there were public health emergencies directly reported via the disease surveillance information management system, which accounted for . %.the percentage of timely reporting by county cdcs emergency levels in was presented in table . moreover, the average scores for indicators of coping capability were high in (table ). the average scores for capabilities at recovery stage were lower than those for capabilities at response stage. the average score for data archiving was . , then followed by those for data analyzing ( . ) and concluding ( . ) ( table ). the main findings indicated that china had made significant progress in the four stages after a decade's efforts, especially in preparation, readiness, and response stages. this has been demonstrated by other researches [ , ] . the average percentages of cdcs with an emergency response office, a leadership group and an expert panel were . %, . % and . % in , respectively. this suggests that a phpm system with better leadership has been established in china. soon after the sars outbreak, chinese governments at different levels were urged to establish a sars headquarters at cdcs to shoulder the responsibilities of unified leadership and command during public health emergencies. the emergency response law of the people's republic of china issued in formally and strongly stipulated the establishment of the emergency management system that urged unified leadership, comprehensive coordination, categorized management, graded responsibility, and territorial management. the capability for building mechanisms comprised of information sharing, on-site treatment and response-material deployment increased to more than % in . boosted by the sars outbreak in , various authorities consecutively issued a series of regulations that standardized the phems in terms of macro-level management, professional categories, disposal processes, etc. from the perspective of macro-level management, regulations included emergency management [ ] , organizational establishment [ ] , coordination mechanisms [ ] , etc. from the perspective of professional categories, regulations standardized the responses to nuclear accidents [ ] , infectious disease outbreaks [ ] , etc. from the perspective of disposal processes, regulations clearly guided emergency response plans [ ] , exercising [ ] , information reporting [ ] , etc. another notable foundation is that the growth of resources including workforce and stockpile was . % and . %, respectively. since , intensive investments by governments have contributed to the improvements on the following aspects. first, funding for cdcs across different levels changed from balanced allocation to full fiscal funding after . total income governmental funding increased from . % in to . % in [ ] . second, cdcs' staff were overall more educated. the percentage of staff with bachelor degree or higher increased from . % in to . % in [ ] . last, the total value of fixed assets of all cdcs increased from . billion cn ¥ in to . billion cn¥ in [ ] . available research showed that the quantity and quality of emergency staff, governmental-funding level, and fixed assets played important roles in improving the implementation of cdcs' capabilities in the phems [ ] . a firm leadership, a favorable mechanism and sufficient resources are the key elements of a well-developed phpms [ ] . it is undeniable that the phems' achievements in the past decade are remarkable. china's active and constructive contributions have been highly valued by the global community; for example, china's response to h n in was recognized as "exemplary" by the who [ ] . the three leading guarantees of china could be referenced by developing and other underdeveloped countries. however, to cope with future challenges in global health security, the following aspects require strengthening. first, preventive governance is necessary. the recovery stage capabilities were the weakest, which is far from achieving the standard of full recovery including sustainability, resilience after crisis and feedback to preparationstage. the prediction, communication, and social services during and after emergencies require improvement. second, balanced development at different regions and levels is very important. county cdcs in the front lines [ ] had the weakest capabilities. one possible reason was that the relevant policies including contingency plan, work specifications, and guidelines were not instructive and operable enough for county cdcs [ ] . another reason was an inequitable distribution of personnel in urban and rural areas [ ] . available data showed that compared with county cdcs, a greater number of personnel with degree higher than bachelor worked at provincial and municipal cdcs [ ] . additionally, the governmental funding per staff for county cdcs in was . million cn¥, which was much lower than the funding at municipal and provincial cdcs ( . and . million cn¥, respectively) [ ] . from the perspective of regional disparity, cdcs in western region were the weakest. reasons include that it had the poorest fiscal capacity to fund cdcs; a limited personnel size; and an inadequate stockpile in terms of working budget, timely reserves, and prompt delivery [ ] . third, the application of new technologies should keep pace with science and technology development. for example, the disease surveillance systems need to be integrated with the use of standard data formats and allow the public health community to respond more quickly to public health threats [ ] . a stockpile management and tracking system could also be designed and used to manage stockpiles across different levels and regions [ ] . the available assessment indicators are relatively narrower in comparison with those such as the capability nearly half the indicators were binary ("yes" or "no"), so the quality of policy implementation and accountability could not be judged. although logic judgments and audit procedures were conducted, recall bias may still exist. despite these limitations, the main contribution of this paper are the findings based on the data from two rounds of national field surveys conducted in to in china. we believe that this contribution is theoretically and practically relevant because the lessons china's government learned from the sars outbreak provide an emergency response framework that can be employed by developing countries. since the sars outbreak, china has built an effective phems and achieved comprehensive progress and improvements at preparation, readiness, response, and recovery. nevertheless, lacks of conceptual crisis management and preventive governance, disparities across regions and levels, and insufficient application of new technologies remain. future priorities should be to develop the recovery stage, establish a closed-feedback loop between recovery and preparation stages, and strengthen capability-building cdcs in western areas through increasing governmental funding and improving the quality of response personnel. the guarantees of leadership, regulations, and resources provide useful references for other developing countries. this survey was administered in the collaboration with national health commission of the people's republic of china (the former ministry of health), and the data ownership belongs to former moh. we just got the admission of certain data fields to analyze, so we are sorry that we cannot provide basic data. authors' contributions ms participated in study design and conception, data acquisition, data analysis, manuscript drafting, and funding acquisition. nx participated in data analysis and manuscript drafting. cl, yw and ll participated in data acquisition. dw participated in data analysis. jz participated in discussion and manuscript revision. my, yz, hw, ps, zc and jy participated in the design and conceptualization of the study, acquisition of data, and data interpretation. jw, yl, ql, xw, zb, mf, and lf participated in the interpretation and acquisition of data. mh participated in the design and conceptualization of study, acquisition of data, revising of the manuscript, acquisition of funding, and supervision. all authors read and approved the final manuscript. the study was approved by the medical research ethics committee at the school of public health of fudan university. the access to the survey data used in this study was approved by the national health commission of the people's republic of china (the former ministry of health). this study didn't involve human participants and there was no data collected from humans or animals. consent to participate for patients were not applicable. not applicable. the authors declare that they have no competing interests. springer nature remains neutral with 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family planning commission of the people's republic of china. statistical yearbook of china's health and family planning emergency capability construction of institution of disease prevention and control updated guidelines for evaluating public health surveillance systems: recommendations from the guidelines working group development of the inventory management and tracking system (imats) to track the availability of public health department medical countermeasures during public health emergencies key: cord- -mvxz lx authors: barraclough, simon title: australia's international health relations in date: - - journal: aust new zealand health policy doi: . / - - - sha: doc_id: cord_uid: mvxz lx a survey for the year of significant developments in australia's official international health relations, and their domestic ramifications, is presented. the discussion is set within the broader context of australian foreign policy. sources include official documents, media reports and consultations with officers of the department of health and ageing responsible for international linkages. in broad terms, these health relations encompass a range of interactions with consequences for health, including: membership of global and regional bodies; the negotiation of international agreements; action to counter particular external threats to health; assistance to developing countries; and international trade and investment in health-related goods and services. in there were continuing developments in all these areas within a wider foreign affairs context overshadowed by official policy concerns about global and regional security, the deployment of the australian armed forces in various theatres of service, and renewed fears of the human and economic costs of infectious diseases. balancing these concerns with national defence were renewed efforts to forge bi-lateral trade links in global trade environment characterized by the emergence of trade blocs centred in north america, europe and southeast asia. although consultation occurs with states and territories, it is the australian government that is constitutionally responsible for conducting australia's international relations. these responsibilities include appointing representatives to international bodies and organizations, such as the united nations and its various agencies, including the world health organization and assenting to agreements and regulations promulgated by international agencies. the formulation and implementation of policy with direct or indirect international health ramifications is not centralized, but is usually the result of consultations between various relevant government departments and statutory authorities. an important element of the australian government's foreign affairs powers relates to international treaties. while a degree of consultation with state and territory governments and with the public occurs, and the national parliament is able to scrutinize and comment upon international treaties, it is the executive that has the final decision on such agreements. in australia continued to play a strategically important and respected role in international organizations concerned with health, especially the world health organization. at the world health assembly, the governing body of the who, the australian delegation supported resolutions concerned with strengthening nursing and midwifery and child and adolescent health. in the wake of sars, australia also supported the review of the international health regulations and is likely to subscribe to them [ ]. the voluntary nature of who standards and regulations, which can be accepted or rejected by member states, is well illustrated by the international health regulations since australia and papua new guinea declined to accept them when they were last promulgated. australia should be better placed to influence developments in who in the next three years as a result of being nominated for a term on the executive board. the department of health and ageing was closely involved with international comparative health data projects including who's world health survey and the health systems performance survey of the organization for economic cooperation and development. australia's participation in the health mandate of the commonwealth of nations was illustrated by the therapeutic goods administration's provision of a secretariat for the clearing house of commonwealth agencies for chemical safety. australia also participated in the meeting of commonwealth health ministers on the eve of the annual world health assembly of who in geneva [ ]. in december australia signed the framework convention on tobacco control (fctc) the first multilateral treaty negotiated under the auspices of the world health organization. for the first time, nations were invited to implement control measures covering such issues as health warnings, advertising, packaging and labelling, sales, and smuggling. they were also called upon to embrace policy measures designed to counter the global tobacco epidemic [ ] . the fctc provided an impetus to the domestic policies of many countries with limited progress on tobacco control and also allowed for the transnational activities of tobacco corporations to be countered with global policy action. the fctc has limited potential to further australian domestic policy, which is in advance of that in most countries. if necessary, the australian government could call upon its "external affairs" to assert constitutional primacy over this policy area. however, this is unlikely in the context of close cooperation between various levels of government in australia in establishing national tobacco control policies. australian leadership was evident in who's formulation of the fctc, having been nominated by the western pacific region as vice-chair of the bureau for the negotiating body. a reciprocal health care agreement with norway was signed, further expanding the rights of australian residents to immediate and necessary treatment in the national health systems of countries with which australia has reciprocal treaties. these include new zealand, uk, italy, malta, holland, sweden, finland, and the republic of ireland. these arrangements are "cost neutral" and do not include costly accounting or administrative procedures. in terms of domestic policy, the continuing "internationalisation" of medicare (pioneered by the hawke labor party ministry at the time of medicare's introduction) by the liberal-national party coalition is paradoxical since local citizens are being encouraged to opt out of public hospital treatment through a rebate on private health insurance and penalties for higher income earners who do not insure privately. whilst these agreements have cemented closer diplomatic ties, their potential benefits to international travellers, especially those subject to punitive insurance premiums or the refusal of insurance due to old age or infirmity, remain inadequately publicized. treaties are also being negotiated with denmark and belgium. following years of negotiations and planning, a treaty was signed with new zealand establishing a single joint therapeutic goods agency. this body, due to commence operations in , will regulate prescription and retail drugs, therapeutic devices and also complementary medicines. it will replace the australian therapeutic goods administration and its new zealand counterpart. to a large extent, the two regulatory systems will have been integrated, although there are still areas of disagreement (e.g. policies on the advertising of pbs medicines) which will need to be negotiated. this joint agency creates a model in international health relations which other states could profitably emulate where they share common concerns and have similar health systems. in december the two countries finalized treaty arrangements establishing both a joint standards code and a joint statutory authority, food standards australia new zealand [ ]. these arrangements parallel bi-lateral developments for the joint regulation of food standards. these developments have furthered australian foreign policy concerned with establishing trans-tasman free trade, commenced some two decades ago with the negotiation of the closer economic relations agreement with new zealand. the new regulatory arrangements have created a virtual trans-tasman free market in food (subject to plant and animal quarantine considerations) and therapeutic drugs. while not having the legal status of a treaty, for some years the department of health and ageing has had memoranda of understanding with its counterparts in china, indonesia, thailand and japan. in further activities were undertaken under the auspices of these agreements. during the state visit of china's president hu jinta, a plan of action was signed between the two health ministries. the indonesian relationship continued with the inclusion of a health delegation to the sixth australia indonesia ministerial forum in jakarta in march, preceded by two rounds of meetings between officials of the indonesian and australian health departments. the australia-japan partnership in health and family services formed the basis for negotiations for joint research on mental health and an international conference on suicide prevention [ ] . in a related development, the department of foreign affairs and trade promoted aged care expertise as an export service through the australia japan conference. in the course of australia finalized free trade agreements (in reality, preferential trade agreements) with singapore and thailand and continued negotiations with the usa [ ] . from the perspective of the australian health industry, the agreement with singapore offered tariff-free trade in pharmaceuticals and other therapeutic goods and the gradual removal of tariffs in the case of thailand. all countries imposed reservations on free trade in the sensitive areas of health services, although traditional thai massage exponents will be permitted to operate in australia. domestically, these agreements required intersectoral policy collaboration in the interests of health. policy makers in the department of health needed to intensify their understanding of the dynamics of international trade, while those making foreign policy had to consider the health dimensions of ostensibly commercial arrangements. the free trade agreement with the usa raised controversies about attempts to include the pharmaceutical benefits scheme (pbs) in concessions demanded by us negotiators. these issues have been outlined in the account of developments in the pbs elsewhere in this series of review articles. the emergence and rapid spread of severe acute respiratory syndrome (sars) to several countries in east and southeast asia and to canada revived popular atavistic fears of pandemics and damaged the tourism and travel industry, as well as some australian suppliers of goods and services to asia. who issued a global alert on the disease in march, and the last reported case of international occurred in july. so serious was the threat of sars to the economies of some countries that a special meeting of health ministers, attended by australia, was organized by asia-pacific economic cooperation (apec) to discuss the situation. a task force was subsequently established by apec to deal with sars. an example of the economic costs of the disease was the decision by the governments of singapore and australia to postpone negotiations on a greater share of the sydney-los angeles air route (dominated by qantas) for the singapore carrier, due to uncertainty about demand. in australia sars was declared a quarantinable disease under the quarantine act and policy guidelines for health professionals, airline and border control staff and the general public were developed by the department of health and ageing, which also led an inter-departmental task force to monitor world developments. until july , when the who announced that no country was still considered sars-affected, international aircraft arriving at australian airports were required to obtain "sarsfree" clearance, nurses were posted at airports and restrictions on elective surgery were placed on travellers returning from affected countries [ ] . during the period of who's alert, australia had reported only five probable, and one laboratory-confirmed, case of sars. australia's official international development assistance programme is an important foreign policy tool, especially in the asia-pacific region. some $ m. (of a total of $ . b.) was allocated to health-related international development assistance in - budget of the australian agency for international development (ausaid). however, while australia's contribution to hiv/aids control and its regional advisory role associated with sars were acknowledged by the foreign affairs minister in his report to parliament, health assistance received little prominence. security, good governance and counter-terrorism were emphasized as the focus for the official foreign aid programme. support for essential services in papua new guinea continued as a major imperative [ ] . the lower priority of health was further underscored by a decision to no longer appoint designated health advisors to the permanent staff of ausaid. it should be noted, however, that the emergence of sars served to reinforce health as an important element on the international assistance agenda. the fact that the domestic health workforce is now part of a global market for skilled workers was further demonstrated by continuing efforts to recruit nurses from overseas, the decision of the australian health ministers conference to sanction dentists from selected commonwealth countries to work in public clinics. in addition, a scheme to recruit overseas-trained medical practitioners was included in the australian government's medicare plus policy initiatives [ ] . it is intended that these doctors will work in rural and remote areas officially designated as having medical workforce shortages and also in positions within aboriginal controlled community health services. yet, metropolitan hospitals are have also become reliant upon overseas-trained doctors for their staffing. this policy, accompanied by the liberalization of immigration arrangements for medical doctors, has represented a volte face from previous policies deliberately designed to discourage foreign doctors from immigrating in the belief that controlling the number of doctors would contribute to cost-containments of medicare. it also continues to raise the ethical danger of australia contributing to a "brain drain" of medical staff from countries that are themselves short of such expertise. in the commonwealth of nations had agreed to a code of practice for the international recruitment of health workers to help safeguard the interests of developing nations. australia has endorsed the code. the australian government will need to handle policies associated with the recruitment of overseas-trained health personnel with care due to professional sensitivities and the need for legislation at the state level to regularize the status of some professions. this brief review of australia's international health relations in has demonstrated that health must be seen as an integral part of trade and security within the wider foreign policy context. the protection of health in free trade arrangements is important for their domestic legitimacy. it is vital that those involved in health policy are aware of its potential international dimensions, while those responsible for foreign affairs include health in their approach. official health linkages have served to promote good will in some otherwise difficult relationships, as has been the case with indonesia. they have also helped to promote a positive international image for australia. world health organization, who framework convention on tobacco control wto and free trade agreements department of health and ageing the opinions expressed in this article are the sole responsibility of the author. key: cord- -b j sf authors: karcher, nicole r.; barch, deanna m. title: the abcd study: understanding the development of risk for mental and physical health outcomes date: - - journal: neuropsychopharmacology doi: . /s - - - sha: doc_id: cord_uid: b j sf following in the footsteps of other large “population neuroscience” studies, the adolescent brain cognitive development℠ (abcd) study is the largest in the u.s. assessing brain development. the study is examining approximately , youth from sites from age to for approximately ten years into young adulthood. the abcd study® has completed recruitment for the baseline sample generally using a multi-stage probability sample including a stratified random sample of schools. the dataset has a wealth of measured attributes of youths and their environment, including neuroimaging, cognitive, biospecimen, behavioral, youth self-report and parent self-report metrics, and environmental measures. the initial goal of the abcd study was to examine risk and resiliency factors associated with the development of substance use, but the project has expanded far beyond this initial set of questions and will also greatly inform our understanding of the contributions of biospecimens (e.g., pubertal hormones), neural alterations, and environmental factors to the development of both healthy behavior and brain function as well as risk for poor mental and physical outcomes. this review outlines how the abcd study was designed to elucidate factors associated with the development of negative mental and physical health outcomes and will provide a selective overview of results emerging from the abcd study. such emerging data includes initial validation of new instruments, important new information about the prevalence and correlates of mental health challenges in middle childhood, and promising data regarding neural correlates of both healthy and disordered behavior. in addition, we will discuss the challenges and opportunities to understanding both healthy development and the emergence of risk from abcd study data. finally, we will overview the future directions of this large undertaking and the ways in which it will shape our understanding of the development of risk for poor mental and physical health outcomes. a number of large "population neuroscience" studies have been undertaken over the past two decades, both in the u.s. and internationally, ushering in an exciting new era in understanding the development of risk for negative physical and mental health outcomes. for example, the adolescent brain cognitive develop-ment℠ (abcd) study is currently underway and was devised to better understand the development of both healthy and disrupted brain and behavioral development [ ] [ ] [ ] . the abcd study® was begun in the footsteps of several other studies pioneering open access techniques, non-convenience study samples, and including longitudinal and neuroimaging components (for e.g., see ref. [ ] [ ] [ ] ). the abcd study is the largest study in the u.s. to date assessing brain development, examining youth from age to for approximately ten years into young adulthood. the abcd study dataset has a wealth of measured attributes of youths and their environment, which will be described below, including neuroimaging, cognitive, biospecimen, behavioral, youth self report and parent self-report metrics, and environmental measures. initial driving questions of the abcd study included examining risk and resiliency factors associated with the development of substance use [ , , ] . however, the abcd study has expanded beyond this initial set of questions and will also greatly inform our understanding of the contributions of biospecimen-derived (e.g., pubertal hormones, genomic, and epigenetic factors), neural, and environmental factors to the etiology of mental and physical outcomes from middle childhood through early adulthood [ ] . the abcd study provides many unique opportunities for understanding the development of both healthy behaviors and risk for mental health challenges. first, the abcd study utilized a school-based national recruitment strategy with limited exclusion criteria, helping to overcome challenges to previous general population studies that generally did not include neuroimaging [ ] as well as attempts to understand the risk factors associated with negative outcomes that relied on convenience samples [ ] . second, the abcd study also includes an embedded twin sample. this will allow researchers to better disentangle the influences of genetic versus environmental factors on development [ ] . third, the abcd study has an unprecedented sample size (i.e., , youth at baseline). this enables the development of reliable standards of development across a number of metrics, including the brain, biospecimens (e.g., pubertal hormones), and cognition. fourth, the abcd study focuses on adolescence. adolescence is arguably a critical and unique period for understanding the evolution of risk and resiliency [ ] . fifth, the abcd study will follow youth longitudinally throughout adolescence. this will enable examining which factors most strongly predict the emergence and progression of both positive and negative physical and mental health outcomes. the current review will describe how the abcd study was designed to elucidate factors associated with the development of negative mental and physical health outcomes. this review will also provide a selective overview of results already emerging from the abcd study. this review will discuss the challenges and opportunities to understanding the development of risk using the abcd study. lastly, we will discuss the future directions of this massive undertaking that will shape our understanding of the development of risk in adolescence. the abcd study has completed recruitment for the baseline study sample (n = , ; youth = - -years-old; . % female; . % white, . % black, . % hispanic, . % asian, and . % other [e.g., biracial]) and will be continuing to follow these youth for at least ten years. an important motivation for abcd study sampling techniques was to reflect the sociodemographic variation of the us population. the recruitment approach of the abcd study was generally through public schools, including charter and private elementary schools, though the embedded twin sample (described below) used a birth record approach. overall, the abcd study aimed to utilize a multi-stage probability sample of eligible youth, selecting a stratified, probability sample of schools across the u.s. in order to capture demographic diversity [ ] . however, some participants (< %) were recruited via other means, including through community events, non-targeted schools, and referral systems. further, the selection of collaborating sites was constrained by the requirement that engaged locations had to have both the research expertize and the neuroimaging equipment required by abcd study protocol [ ] . the abcd study has sites that are distributed nationally. for each site, the abcd study created a catchment area, defined as all schools within miles of the research institution [ ] . each school within the catchment area was coded according to several factors, including geographical location, racial, ethnic and sex composition, and percentage of students receiving free or subsidized lunches as an index of socioeconomic status (ses). based on this information, the abcd study used stratified sampling of schools within each site's catchment area, and a subset of schools was randomly selected from this list of potential schools within each catchment area. procedures were used to ensure that systematic sampling biases in recruitment at the school level were minimized [ ] . the abcd study then recruited eligible children from each of the randomly selected schools within the catchment area. initial recruitment often involved the delivery of hard and electronic copies of recruitment materials to caregivers. in total, , children completed the baseline assessment. in the end, the abcd study sample is epidemiologically informed and designed to reduce selection bias that plagues convenience samples. however, the degree to which this sample is fully representative of the u.s. population will vary across outcome measure examined. the use of weighting methods that evaluate the distributions in relationship to u.s. demographic characteristics will be a helpful additional tool when attempting to make claims about representativeness [ ] . in addition to this school-based approach, there are four abcd study sites that recruited samples of monozygotic and dizygotic twins (washington university in st. louis, university of minnesota, university of colorado at boulder, and virginia commonwealth university), resulting in~ twin pairs in the baseline sample. these sites each have over years of experiences in the recruitment of twin populations and therefore used existing recruitment processes [ ] . for example, these sites used approved vital records approaches to capture a diverse set of twins generally representative of the demographics of their respective states [ ] . each of these sites also recruited "singletons" using the school-based approach described above. the inclusion of twin samples was designed to enhance the ability to make causal inferences about factors contributing to both healthy and disordered brain and behavioral development. for more details on sampling strategy, recruitment, and retention, including twin sample recruitment, please see refs. [ , , ] . the abcd study is a consortium composed of a coordinating center, a data analysis, and informatics center, and members from the research sites (https://abcdstudy.org/study-sites/). work groups facilitate data collection and quality control for current and future abcd study data collection waves. all youth are asked to come for in-person assessment sessions once a year, with brief remote assessments at months between in-person sessions. self-report, behavioral, and biospecimen collections occur yearly, while brain imaging occurs bi-annually (table ) . below, measures collected for each of the assessment domains are briefly reviewed. many of these assessments are described in more detail in a special issue of developmental cognitive neuroscience published in [ , , , ] . the abcd study assessments can be loosely grouped into seven domains: substance use, mental health, physical health and biospecimens, neurocognition, gender identity and sexual health, culture and environment, and brain imaging. each domain was designed to use instruments with documented reliability and validity, be developmentally sensitive, engage the most appropriate informant depending on the developmental stage and domain (e.g., parent versus youth), minimize participant burden, and be informed by previous relevant literature on both healthy and disordered brain and behavioral development. furthermore, the inclusion of multiple informants for certain measures, including obtaining information from youth, caregivers, and teachers regarding youth mental health at baseline (youth = - -years-old), helps to mitigate potential unreliability of youth reports due to variability in language skills and retrospective reporting problems. for each domain, additional assessments have been added in follow-up years, which are described in the annual release notes of the abcd study data releases on the nih national data archive. additionally, abcd consortium members have added several sub-studies to the abcd study protocol for future waves of data collection. these sub-studies include adding measures to address reactions to hurricane irma and the covid- pandemic, and a sub-study focused on behavior in youth that might put them at risk for involvement in the justice system. substance use. for an overview of measures started at baseline and year (youth = - -years-old), please see ref. [ ] . the goal of the substance use assessment was to start with the very earliest indicators of exposure to and knowledge about substances, and then to capture the onset, timing, and quantity of any substance use that emerges during the course of the abcd study data collection. a variety of measures collected from youth are used to accomplish this goal, with a central one being the timeline followback interview [ , ] designed to establish the specifics of substance use onset and timing. factors impacting substance use are also assessed, including assessments about intentions to use, expectations about substance effects, curiosity, and motivations regarding substances, perceptions about peer beliefs regarding substances, assessment of sibling use, and community risk and protective factors. further, parents are asked about their youth's substance use, family rules about substance use, availability of substances in the environment, and a range of community risk and protective factors. lastly, biospecimens (saliva and hair) are assessed for exposure to alcohol and substances. mental health. for an overview of all measures that started at baseline and year , please see ref. [ ] . the goal of the mental health assessments is capturing categorical and dimensional assessments of current and past mental health from the parent and youth perspective, as well as teacher perspective, and assessing traits and characteristics relevant to understanding risk trajectories for mental health. the core of the categorical assessment of youth mental health is the new computerized kiddie-structured assessment for affecitive disorders and schizophrenia (ksads), used to assess parent-report of youth mental health as well as youth's self-report [ ] [ ] [ ] . this version of the ksads is not clinician administered, though youth are aided by research assistants. in early abcd study assessment waves, most modules are completed by a parent/caregiver (mood, psychosis, anxiety, externalizing, sleep, and suicidality), with a subset also completed by youth (mood, anxiety, sleep, and suicidality), with the number of modules completed by youth increasing across the course of the study as developmentally appropriate. a range of dimensional measures of mental health are completed by either or both the parent/caregiver and youth, and the core of these dimensional assessments is the achenbach system of emprically based assessment (aseba) system [ , ] generously provided at no cost to the abcd study. the parent/ caregiver annually completes the child behavioral checklist as a broad dimensional assessment of youth mental health. the parent/caregiver also completes additional measures of early signs of mania and autism spectrum symptoms, youth temperament, life events, and emotion regulation abilities, the family's mental health history, and their own mental health and stress. the youth completes additional measures of psychotic-like experiences (ples), mania, and conduct disorder, as well as personality traits (e.g., impulsivity, behavioral activation and inhibition, and emotion regulation) and relevant experiences, including friendships, peer relationships, bullying, and life events. the youth completes the aseba brief problem monitor (bpm) every months. lastly, teachers are also asked to report on youth mental health using the bpm for teachers. physical health and biospecimens/genetics. for an overview of all measures that started at baseline and year , please see ref. [ ] . this assessment includes a lifetime medical, head injury, and developmental history for the youth provided by the parent/ = nih toobox; = "cold" cogn nitive e me easures; = "hot" c cogni itive mea asure es; = = geo ocode ed factor rs; = b brain imag ging the abcd study: understanding the development of risk for mental and. . . nr karcher and dm barch caregiver at baseline, along with annual updates about medical experiences, medications, and head injuries (including sports related). both the parent/caregiver and youth provide annual descriptions of their pubertal status and saliva assessments of pubertal hormones (including assessing levels of testosterone and dhea in males and females, as well as estradiol in females). parent/caregiver and youth also report on experiences with sleep and sleep disorders, including youth reports of sleep chronotypes, respiratory function, and pain experiences. the youth and/or their parent/caregiver provide annual information about diet, frequency of exercise, involvement in sports and other activities, and time spent using various types of electronic media, including tv, videos, social media, etc. further, in year of data collection (youth = - -years-old), all youth were asked to wear a fitbit for weeks. fitbits provide data on heart rate, physical activity levels, and sleep. biospecimens are collected, including baby teeth, saliva, hair, and blood, for purposes of screening for and examining effects of drug use, assessing pubertal hormones, characterizing genetic and epigenetic factors, and assessing the presence and effects of exposure to environmental toxins [ ] . youth who initially provided saliva for dna assessment are asked to provide blood in later years as they become more comfortable with blood draws. neurocognition. for an overview of all measures that started at baseline and year , please see ref. [ ] . the base of the neurocognitive assessment for abcd study is the nih toolbox [ , ] , with the complete cognitive toolbox administered at baseline, and the majority of tasks administered every years. the toolbox measures were complemented at baseline by additional assessments of verbal learning, matrix reasoning, spatial processing, and delay discounting, with all of these measures other than matrix reasoning repeated approximately for every years [ ] . additional cognitive measures are administered in alternating years, including those that focus on more "hot" aspects of cognition, including an emotional stroop task, a monetary decision-making task, and a social influence task. assessments of math ability were introduced in year (youth = - -years-old). these assessments are contextualized by vision assessments for every years, and a measure of hand dominance. gender identity and sexual health. the goal of the gender identity and sexual health assessments are to provide developmentally appropriate assessments of gender identity and expression, as well as sexual identity and communication about sexual health. both youth and parent complete a questionnaire about gender identity, including questions on gender identity and gender expression, with the youth also reporting on dimensional assessments of gender identity. for an overview of all measures that started at baseline and year , please see ref. [ ] . the assessments of culture and environment include both youth and parent/caregiver's perspectives on family relationships, conflict, parent acceptance and rules, familial cultural experiences and values, pet ownership, and other aspects of the home environment such as the nature of home spaces and parent-youth interactions in the home around cognitive and emotional behaviors. this domain also assesses characteristics of the neighborhood from the perspective of the youth and/or parent/caregiver, including perceptions of crime and safety, community cohesion, and school attributes. data releases also include several variables geocoded based on the participant's address and derived from publicly available data such as the american community survey's metrics of socioeconomic characteristics. these variables include population density, neighborhood walkability, county-level crime exposure information, census-tract level estimates of area deprivation indices, air pollution exposure (estimated with a resolution of km of address), and lead exposure risk. brain imaging. for an overview of all measures that started at baseline, see ref. [ ] and for processing approaches and information about released data, see ref. [ ] . youth participate in a magnetic resonance imaging (mri) session for every years. this mri assessment includes measures of brain structure, with both t and t weighted imaging and diffusion imaging for assessment of white mater integrity. the mri assessment also includes min of resting state functional connectivity data and functional mri during three different task domains. these domains were designed to capture brain activity during numerous aspects of cognition and emotion function in as short a time as possible, including working memory, response inhibition, anticipation and receipt of rewards and losses, face processing (both neutral and emotional), and subsequent memory. processed data from each of these domains is released in tabular format as part of the abcd annual releases using a variety of brain atlases. raw mri data is available through the fast track release mechanism (https://nda. nih.gov/abcd/query/abcd-fast-track-data.html). the abcd study was begun in the footsteps of several other large population neuroscience studies. these studies include the sanguenay youth study (http://saguenay-youth-study.org; n = ) [ ] , the national institutes of health pediatric mri database (n = ) [ ] , imagen (n = ) [ ] , pediatric imaging, neurocognition, and genetics study (ping) (n = ) [ ] , national consortium on alcohol and neurodevelopment in adolescence (ncanda) (n = ) [ ] , human connectome project (hcp) (n = ) [ , ] , and hcp-development (hcp-d; n = [ ] ), uk biobank (n = over , ) [ ] , generation r (n = ) [ ] , philadelphia neurodevelopment cohort (pnc) (n =~ ) [ ] , and the dunedin multidisciplinary health and development study (n = ) [ ] , among others. as can be seen in table , in general these previous studies were large (sample sizes > ), examined a range of ages from beginning prenatally (generation r) to adulthood populations (e.g., hcp, uk biobank). some followed the sample longitudinally (e.g., imagen, uk biobank, generation r, dunedin, ncanda), or followed a subset longitudinally (e.g., pnc). all included neuroimaging data (e.g., imagen, ping, ncanda, hcp; note the dunedin study did not collect neuroimaging data during childhood or adolescence), or included neuroimaging on a subset of participants (e.g., pnc, uk biobank). notably, several even included longitudinal imaging (e.g., ncanda, generation r, imagen). the abcd study complements and extends beyond these other studies by examining measures across development from middle childhood-adulthood at different sites across the u.s. and conducting assessments for every months and imaging for every years. furthermore, a critical component of the abcd study is the open science framework, whereby the abcd consortium is releasing data collected from the study in annual data releases to the scientific community. this approach builds upon the open science framework of release while data is still being collected pioneered by a number of previous studies, including the hcp and uk biobank projects. overview of emerging findings from the abcd study the abcd study has submitted two data releases, and numerous investigators both within the consortium and from without have been utilizing these data to begin to address questions relevant to both healthy and disordered brain and behavioral relationships. here, we provide a selective review of some of this emerging research. notably, the majority of the published emerging work to date is cross-sectional and focused on the initial baseline data set. the abcd study: understanding the development of risk for mental and. . . however, several emerging studies have utilized the partial data available from year [ , ] . abcd release . is slated for release during august , and will include the entire year and part of year , which will include repeated neuroimaging assessments. these emerging studies vary in scientific rigor, including using appropriate analytic methods (e.g., nested models), using rigorous multiple comparison control, controlling for potential confounds (e.g., age, sex, race/ethnicity, and ses), and replicating findings. several of the emerging studies have implemented each of these rigorous inclusions [ ] [ ] [ ] [ ] , and % included at least one of these methodologies/techniques. emerging studies from the abcd study have been utilizing a variety of measures to examine an array of both adaptive and maladaptive aspects of cognitive, social, emotional, and neural correlates in middle childhood [ , - , , ] . many of the measures already have extensive psychometric data. however, in some cases, measures were shortened to reduce participant burden, adapted for use in a younger population, or created from items selected from various other scales. as such, several early emerging studies from the abcd study have examined psychometric properties and validity for several measures [ , ] . further, emerging studies have begun to utilize the large sample to create short forms [ ] . these emerging studies highlight several exciting avenues for examining the properties and novel uses of the abcd study measures. one of the first emerging studies to analyze abcd study baseline data examined the properties and conducted some initial validation analyses for a measure of ples entitled the prodromal questionnaire-brief child version (pq-bc) [ ] , including conducting measurement invariance analyses and finding the pq-bc functioned similarly across sex and race/ethnicity. another recent emerging study conducted item response theory analyses on the pq-bc and used information gleaned from these analyses to begin the process of creating a short form that theoretically can be used for future clinical purposes [ ] . similarly, another emerging study examined validity evidence for a novel, abbreviated measure of impulsivity in youth, the upps-p impulsive behavior scale [ ] . the authors found adequate measurement invariance across gender, race/ethnicity, household income, and parental education, and examined convergent and discriminant validity across a number of relevant characteristics, including youth-reported and parentreported psychopathology and measures of cognition. lastly, researchers also used abcd study measures to create a -item measure of callous-unemotional traits [ ] , finding evidence for good psychometric properties, including measurement invariance across age, sex, and race, and expected associations with related constructs such as conduct problems, attention deficit and hyperactivity disorder symptoms, and oppositional defiant disorder symptoms. importantly, these findings replicated in an independent sample. these studies provide important evidence that the abcd study sample can be leveraged to conduct rigorous research practices, including examining the psychometric evidence for using existing (or newly created) measures in a middle childhood sample, supporting the use of these measures to better understand the development of risk. prevalence and behavioral correlates of psychopathology. there has been great interest in understanding the prevalence and correlates of a range of forms of psychopathology using the abcd study's large-scale population-based data. several emerging studies have utilized the abcd study data to examine the prevalence of psychopathology in middle childhood, as well as behavioral and cognitive correlates of psychopathology. as previously mentioned, one of the first emerging studies published examining abcd study baseline data examined associations between ples and correlates of psychosis spectrum symptoms [ ] . this emerging study found ples were associated with several expected associations, such as cognitive impairments (including working memory impairments), motor and speech developmental delays, higher internalizing and externalizing symptoms, greater family history of psychosis, and higher scores on other measures of psychosis spectrum symptoms. another emerging study found maladaptive guilt was associated with several expected correlates, including family ses, youth-reported family conflict, history of maternal depression, and parental rejection [ ] . emerging research also examined prevalence of eating disorder diagnoses in middle childhood [ ] , finding the prevalence of overall eating disorder diagnoses was . %, and the prevalence of anorexia nervosa diagnoses was . %. lastly, an emerging study examined the prevalence and associations with suicidality in middle childhood [ ] , finding the prevalence of passive suicidal ideation (as reported by youth or parent) was . %, active suicidal ideation (either non-specific or specific) was . %, and suicide attempts were~ . %. further, the prevalence of non-suicidal self-injury was~ . %. low parental monitoring was associated with suicidal ideation, suicide attempt, and nonsuicidal self-injury, and as with maladaptive guilt, family conflict was associated with suicidal ideation and non-suicidal self-injury. importantly, the authors replicated these findings in a hold-out abcd study baseline sample (i.e., % of the baseline sample). together these emerging studies are beginning to provide an important additional information on the prevalence of various forms of psychopathology in a middle childhood sample, complementing the already existing epidemiological data that is more common in adolescence and adulthood. in particular, this novel data on rates of suicidal ideation and attempts starting in middle childhood is critically informative about the timing of emergence of such thoughts and behavior in relationship to the rates in adolescence already identified by the centers for disease control and prevention. associations between psychopathology and both physical health and the environment. in addition to examining prevalence and behavioral correlates, the abcd study baseline sample has also been utilized to assess associations between psychopathology and several environmental and health-related variables. these emerging studies point to several factors, including prenatal drug use, body mass index (bmi), and cognition already showing associations with psychopathology and other health-relevant variables in middle childhood. emerging work indicates that prenatal cannabis exposure after knowledge of pregnancy is associated with ples, but not internalizing, externalizing, or attention symptoms [ ] . another emerging study examined associations between health and environment, including correlates of bmi in middle childhood [ ] , finding attention problems, social problems, and screen time were all associated with higher bmi, with some evidence that demographic factors (e.g., hispanic ethnicity, lower income) were most strongly associated with greater bmi. other emerging research examined associations with sexual orientation and/or gender identity status [ ] , finding that less than % of the sample identifies as a sexual orientation or gender identity minority, and that minority status was not a source of substantial family or school problems. however, further emerging research did show that sexual orientation minority status was associated with greater prevalence of mood disorders and suicidality than in heterosexual-identifying youth [ ] . another emerging study examined the structure of cognition and found evidence for three broad factors representing general cognition, executive function and learning/memory [ ] , additionally finding that while parent-reported psychopathology (perhaps especially externalizing symptoms and stress reactivity) was associated with cognition, the sizes of the effects were small in magnitude. furthermore, other emerging work found little evidence that learning a second language was associated with higher executive functioning [ ] . another emerging study examined associations between global cognition and healthrelated variables, finding higher global cognition scores were associated with meeting recommendations for sleep, screen time, and physical activity [ ] . these emerging studies provide important information that will be critical for understanding the development of risk for physical and mental health-related outcomes, as well as several potential avenues for the development of health-related resources and interventions. youth behavior and brain structure, function, and connectivity. research has begun to utilize the wealth of neuroimaging data available from the baseline sample (i.e., data releases . and . . ) in novel and innovative ways to begin to analyze important questions about early neural markers of risk. emerging research examining resting state functional connectivity (rsfc) to delineate the functional architecture of the brain found rsfc networks were highly reproducible across two samples of abcd study data, shared many features of adult-level networks, and showed associations with cognitive functioning [ ] . other emerging research found rsfc associations with general cognitive ability were generalizable across abcd study sites and that rsfc within and between task control networks were associated with variability in general cognitive ability [ ] . other emerging work examining brain-cognition associations found that with higher risk of lead exposure, lower family income was associated with lower cognitive functioning, lower cortical volume, and lower surface area [ ] . emerging findings also found higher screen media activity was associated visual brain areas (e.g., occipital cortex) [ ] , with these associations showing mixed positive and negative relations to cognitive functioning. other emerging baseline research has found that higher bmi is associated with lower cortical thickness, especially in prefrontal regions, and lower executive functioning performance [ , ] . interestingly, other emerging work found an association between sleep duration and both cognitive function and psychopathology in youth, as well as with variation in brain volume in a variety of regions in the prefrontal, parietal, and temporal cortices [ ] . furthermore, hippocampal volume was associated with depressive symptoms in males and involvement in sports was associated with fewer depressive symptoms, with some evidence that hippocampal volume mediated the association between sports involvement and depressive symptoms [ ] . other emerging research found risk for depression, as assessed by parental history of depression, was associated with lower putamen volume [ ] . further, emerging research examining specifically anhedonia found associations with hypoconnectivity in several rsfc networks, as well as lower activation compared to a group not endorsing anhedonia during reward anticipation, including in cingulo-opercular (con) network regions and the striatum [ ] . other emerging research found evidence that higher ples were associated with lower functional connectivity in several rsfc networks, including lower con and default mode connectivity [ ] . another interesting emerging study found youth with disruptive behavior problems who also had callous and unemotional traits showed lower gray matter in the amygdala and the insula compared to typically-developing youth. further, youth with disruptive behavior problems with and without callous/ unemotional traits showed alterations in several regions including lower hippocampal volume, though it was limited to the left hippocampus in disruptive youth without callous/unemotional traits [ ] . collectively such data begin to establish the early emergence of alterations in brain structure, function and connectivity associated with a range of forms of psychopathology and individual differences in cognitive function and behavior, as well as critical environmental influences that shape brain development. crucially, they also begin to identify both commonalities and dissociations in these relationships. for example, lower hippocampal volume has been associated with both depression and disruptive behavior, while lower amygdala volume has only been associated with disruptive behavior. in terms of connectivity, disruption in the connectivity of the con network has been associated with higher ples, while disrupted connectivity between the con and the striatum has been associated with anhedonia. it will be critical to determine whether these similarities and dissociations remain over the course of development or whether the patterns of disrupted brain structure, function and connectivity evolve throughout development. challenges and opportunities of the abcd study challenges. one challenge the abcd study has encountered is that given data is open access, multiple groups can publish the same or very similar articles. although members of the abcd consortium are encouraged to publish research proposals on the internal abcd study site, this information is not available to the public. other challenges for large-scale studies in general include retaining subjects followed across a decade and potential biases in drop-out rates (e.g., lower ses populations). the abcd study has attempted to mitigate these challenges by developing strategies to maintain rapport, keeping detailed current locator information, offering participation-related resources (e.g., travel assistance), and monitoring retention during bi-monthly meetings [ ] . effect sizes: what to expect. as outlined in a recent paper [ ] , large sample sizes are necessary to examine the earliest markers and mechanisms of disease processes, as these markers are likely to be more subtle early in the course of illness. an opportunity that also presents a challenge is these large data sets enable the detection of very subtle effects not generally detectable in smaller sample studies. the challenge of detecting small effects is determining whether very small effects (i.e., < % of variance explained) are practically meaningful [ ] . large well-powered samples enable the detection of the earliest subtle associations between predictor and outcome of small effect, prior to larger effect size associations that may emerge later in the disease process. for example, estimating the prevalence of major depressive disorder at % in middle childhood [ ] , the abcd study's power = . to detect small effect (cohen's d = . ) differences between individuals with major depressive disorder and controls. additionally, it is entirely expected that many of these analyses will produce small effects. first, baseline abcd study analyses are examining early risk factors of negative mental and physical health outcomes in a generally high functioning non-clinical sample prior to entering the age range of highest risk for a number of negative outcomes (e.g., psychosis spectrum symptoms) [ ] . furthermore, since the abcd study is an epidemiologically informed study with a demographically diverse sample [ ] , rather than a convenience or clinical sample, it is expected that effect sizes will be more "diluted" as they are being examined in the context of a complex set of contextual and background variables. further, our expectations for effect sizes are likely biased, as it is known that underpowered studies overestimate effect sizes [ , ] . thus, the field is in need of well-powered studies, especially in neuroimaging analyses, to better understand the expected effect sizes for these associations in the general population. robust exploratory analyses. another opportunity that the large sample size of the abcd study offers is the possibility of conducting exploratory analyses for questions with no strong a priori hypotheses. as the nimh has recently advocated [ , ] , it will be critical to implement robust and rigorous practices for conducting exploratory analyses. first, we suggest utilizing discovery and replication datasets. researchers conducting exploratory analyses can conduct analyses on the discovery dataset, and examine whether results replicate in the replication dataset, a technique used to improve the replicability of gwas studies [ ] . researchers can match these datasets on demographic variables, including sex, race, ethnicity, and age. given that exploratory analyses are prone to false positives, first examining analyses in a discovery dataset and then testing any findings in a replication dataset reduces the possibility of type i error. furthermore, to the extent that it is possible, researchers should specify hypotheses prior to conducting analyses. ideally, researchers would create a pre-registration or even a registered report detailing hypotheses and analyses prior to conducting analyses (https://cos.io/rr/). specifying even general hypotheses helps frame the results and can put unexpected results into context. further, preregistering analysis approaches even in the absence of specific hypotheses helps to avoid problematic analytic approaches resulting in enhanced false positives [ , ] . correcting for multiple comparisons is also critical when conducting exploratory analyses. it is important to account for experimentwide increased false discovery rates, even when conducting multilevel modeling. further, especially for researchers conducting complicated interaction or genetic analyses, power analyses should be conducted in order to determine whether the analysis is sufficiently powered in the abcd study sample [ ] . lastly, researchers should always use best practices in model specification (e.g., nesting abcd study site and family) [ ] . the importance of replication. the importance of replication is increasingly highlighted as a part of robust research practices [ , ] . accordingly, another opportunity that a large study such as the abcd study affords is within sample replication. the opportunity to conduct a within sample replication can come in several forms. one possibility is researchers can examine the first data release (data release . . ; n = ) and then replicate findings on the remainder of the baseline sample (data release . ; remainder sample n = ). this was recently done examining associations with ples [ ] . in subsequent data releases, researchers will be able to replicate results across waves, paying close attention to expected developmental alterations that may influence results. second, as previously mentioned in the exploratory analyses paragraph, researchers can divide the sample into discovery and replication datasets. third, researchers can also conduct k-fold (e.g., -fold) cross-replication [ ] . k-fold cross validation is used in predictive modeling to test a model's ability to predict new data not used to create the original model. however, the gold standard in replication is to use an independent sample with differing methods and sampling techniques in order to ensure that effects are replicable and generalize across samples. as mentioned in the "overview of the abcd study" section, there are a number of large-scale studies that would be ideal for such a replication. for example, the generation r study is a prospective longitudinal study following individuals from prenatally to young adulthood ( table ) . as with the abcd study, the generation r study is collecting a wide range of outcomes, including physical, behavioral, cognitive, biospecimens, and mri [ ] . in addition, the hcp-d study is collecting data from children ranging from age to (table ) [ ] . although the focus of the hcp-d study is on the development of the brain, the study also collects data on puberty, physical activity, health, genetics, and other relevant mental health correlates such as stress [ , ] . other studies that may be relevant for replication efforts can be found in table . developmental specificity and evolution of risk. the abcd study will provide one of the first opportunities to examine a wealth of neuroimaging, genetics, cognition, psychopathological, and psychosocial factors in the same youth in middle childhood, adolescence, and early adulthood. it will be important for researchers to consider the developmental period in question in order to properly formulate hypotheses regarding risk in each age group, as each period is defined by a unique set of psychosocial and neurobiological alterations. for example, middle childhood is associated with several changes, including continued neuromaturational processes that began in childhood, such as increases in both gray and white matter [ ] . adolescence is a period of often dramatic changes, including hormonal fluctuations and substantial pruning processes [ ] [ ] [ ] [ ] . lastly, young adulthood is associated with another set of changes, including in role functioning [ ] . in terms of the development of risk, each stage has its own unique set of risk-related factors and developmental changes. for example, adolescence is associated with a spiked increase in risk-taking behaviors, including substance use [ , ] . researchers interested in examining abcd study data should carefully tune their questions depending on the developmental period from which they are drawing their sample. for example, researchers interested in understanding the progression of risktaking behaviors, such as the initiation of cannabis use, would likely examine future waves of the abcd study (e.g., at year youth = - -years-old) to identify outcome measures and to evaluate response to substance use, but maybe using predictors from an earlier developmental stage. the developmental period in question will also be critical in terms of the covariates of interest in analyses. pubertal status will be an important covariate in later middle childhood/early adolescence. likewise, substance use will be an important covariate for many analyses in later adolescence/ early adulthood. the abcd study also will provide the opportunity to examine the evolution of risk, including how risk factors change across development and to determine whether there are important variations in the most relevant risk factors at different phases of development. in terms of defining factors that predict variation in developmental trajectories, life course [ ] and developmental psychopathology [ ] theories suggest that early negative experiences can alter a youth's developmental trajectory [ , ] and the accomplishment of developmental milestones. however, research has not elucidated whether the consequences of negative life events in terms of mental health are stronger during different development periods, such as in middle childhood versus adulthood. this would have critical treatment and policy implications. it is also possible that the factors associated with risk may be qualitatively different during different developmental periods. for example, factors associated with risk for depressive symptoms in middle childhood, such as lower physical activity [ ] , may not be associated with risk for depressive symptoms in young adulthood, as these factors become more normative. in contrast, other risk factors, such as chronic stress and poor social support, may be consistently associated with risk for depression across development [ , ] , although the degree of severity may be different in different development periods. thus, it is possible that some risk factors first emerge, and then accumulate over time, versus others are only associated with risk during "critical periods" that may correspond with certain maturational changes. balancing large-scale studies with deep phenotyping. research is increasingly moving towards precision medicine efforts, aiming to tailor interventions for psychopathology to the individual [ , ] . thus, one potential criticism of large-scale population neuroscience efforts is the value and utility of massive research efforts for precision medicine. it is possible that in advancing our understanding of the etiology of mental and physical illness, we could obscure the trees for the forest by examining large-scale efforts as opposed to deep phenotyping. deep phenotyping refers to gathering details about disorder manifestations in a fine-grained manner to more precisely define phenotypes [ ] , as many phenotypes currently fall short of fully capturing the diverse manifestations of the disorder (e.g., schizophrenia, asd). however, deep phenotyping is typically only possible with smaller samples, due to the large amount of resources required. the abcd study varies in the depth of assessment across phenotypes. for alcohol and substance use, the abcd study uses deeper phenotyping, with finer-grained data on patterns of use, including biospecimen collection, youth and parent interviews of use, as well as reports of peer use, expectancies, and consequences of use. combined with collection of neuroimaging and genetic data, the abcd study poses the opportunity to create a nuanced phenotype of alcohol and substance use across adolescence and young adulthood. in contrast, other phenotypes assessed in the abcd study, including psychosis, are assessed with less fine-grained detail. nonetheless, the insights gained from the abcd study can be used to spur subsequent deep phenotyping studies that can examine promising risk factors and mechanisms identified in the abcd study data in a more finegrained fashion in more tailored populations. longitudinal analyses. given that the abcd study is following youth from age to into adulthood, one of the most important future directions is conducting longitudinal analyses. the fields of psychology and psychiatry have made few reliable advances in understanding causal mechanisms underlying the development of negative mental health outcomes, including substance use disorders and psychosis [ ] . following a cohort of youth through a period of significant risk will provide important information about what trajectories of risk factors significantly predict transition to negative mental and physical health outcomes. through examining trajectories of neural, cognitive, social, emotional, school, and hormonal functioning, the abcd study will be able to isolate factors reliably predicting typical versus atypical development from middle childhood into young adulthood [ ] . this ten-year study sets the stage for several potential avenues for longitudinal research, helping to answer fundamental questions about the effects of the onset and progression of symptoms of psychopathology [ ] . a major aim of the abcd study is to longitudinally examine the neurodevelopmental and behavioral effects of substance use. by analyzing development both preexposure and post-exposure, researchers will be able to clarify associations between substance use and outcomes, including neurodevelopmental, neural, behavioral, and cognitive correlates [ , , ] . another aim of the abcd study is to longitudinally examine factors, including social and neurobiological, that might contribute to resiliency either from engaging in substance use or from negative outcomes after initiation [ ] . this information will be critical for intervention development, including offering potential avenues to mitigate risk. thus, longitudinal analyses in the abcd study will enable the examination of trajectories associated with the onset and progression of, as well as resiliency from, psychopathology and substance use. passive data sampling. several passive data collection methods, or data collection methods that do not require active responses from participants but instead collect data from the participant, will become available in future abcd study assessment waves [ ] . passive data collection can be a critical tool for large-scale studies, as it enables additional data without additional burden. the abcd study is conducting passive data collection from mobile devices and wearables (i.e., fitbits). mobile and wearable technologies can capture information about participants that is unable to be adequately captured through self-report, including precision regarding social interactions, sleep quality, and activity levels. one exciting avenue for passive data sampling is understanding the role of social media usage as either risk or resilience markers for physical and mental health outcomes, including substance use. social media use has been linked to psychopathology in adolescents, including higher symptoms of depression and anxiety [ ] . however, previous research has not established screen time as a causal factor in the development of mental health outcomes, or whether altered social media use and screen time are a correlate or consequence of the development of psychopathology [ ] . as noted above, starting at year , the abcd study is also using accelerometers (i.e., fitbits) to examine sleep quality and activity levels. a wealth of research links poor sleep quality to negative physical and mental health outcomes [ , ] . the examination of variables such as sleep quality over time will begin to disentangle causality, such as whether poor sleep is a cause or a consequence of negative mental and physical health outcomes. likewise, increased physical activity is a protective factor for a number of positive physical and mental health outcomes, including maintaining a healthy weight and lessened risk of depressive symptoms [ , ] . starting in year of data collection, the abcd study will also be using an app to assess phone and app usage with youth and parent permission. using passive data sampling, the abcd study will begin to understand the contributions of physical activity level, sleep quality, and social media use to the development and maintenance of negative physical and mental health outcomes. examining complex patterns of interactions. another future direction for abcd study data is examining complex interactions. these examinations will likely take several forms, so the current review will focus on two: modeling moderating influences and examining gene × environment interactions. for the first example of complex interactions, researchers will be able to examine the moderating influences of a multitude of factors including mental health (e.g., internalizing and externalizing symptoms [ ] ); and psychosocial (e.g., parental influences, social support) factors on the initiation of substance abuse. further, questions remain about how different types of substance use, such as drugs, alcohol, and nicotine use interact, including their interactive effects on cognition and neurobiology [ ] . research using the abcd study will also be able to examine how patterns of use interact with psychopathology and psychosocial variables to predict trajectories. for example, it is possible that substance use interacts with poor social support to predict impairments in social and occupational functioning [ ] . the abcd study sets to stage the begin to uncover the complex patterns of interactions among psychopathology, psychosocial factors, and neurobiology, as well as their interactive effects on long-range outcomes. further, the abcd study has oversampled for twins (i.e., the study has approximately twin pairs at baseline). this will allow researchers to leverage this data to examine gene × environmental interactions. briefly, bivariate twin models can be used in order to examine gene × environment interactions [ , ] , including parsing out how variance associated with additive genetic (heritable) and individual-specific environmental factors contribute to the covariance between indices of interest. discordant twin study designs can be used to examine whether one twin who was exposed to a certain environment (e.g., an adverse childhood event) has a different trajectory of psychopathology (e.g., ples) compared to the twin who was not exposed to this environment. this would provide evidence that in the context of certain genetic constitutions, the exposure to negative environments may alter one's trajectory. further, researchers will be able to examine polygenic risk scores, scores created to reflect the weighted effect of individual single nucleotide polymorphisms associated with risk for an outcome, to examine how heightened the genetic risk for disorders interacts with environmental factors to predict development of disorders [ ] . for example, researchers will be able to examine how schizophrenia polygenic risk interacts with factors such as cannabis use to predict the development of schizophrenia spectrum symptoms. thus, researchers can use the abcd study to begin to tease apart complex genetic versus environmental contributions to psychopathology. the current review provided an overview of the goals, methods, initial results, and future directions for the abcd study for understanding the development of risk. the abcd study is a historic study following youth from ages into early adulthood and is currently in its fourth year of data collection. the study operates under an open science framework and therefore annually releases data to the public. it is a large-scale population neuroscience study examining a heterogenous population recruited to reflect u.s. national sociodemographic proportions. the study is collecting data across a spectrum of domains, including mental and physical health, culture and environment, biospecimens, and neuroimaging. emerging cross-sectional results published from this study have already contributed to novel insights regarding psychopathology and brain and behavior correlates in middle childhood. the abcd study aims to better understand both normative and non-normative trajectories of development, examining risk for the development of many mental and physical health outcomes, including substance use. the characteristics of the abcd study, including a large heterogeneous sample longitudinally following youth across development, pose unique opportunities for understanding the development of risk. the heterogenous sample combined with examining a middle childhood sample, years prior to the period of greatest risk for many disorders, often results in finding smallmoderate effects. further, researchers have the opportunity to conduct exploratory analyses that incorporate rigorous best practices for data analysis including conducting power analyses. it will be crucial for researchers to replicate findings either using the abcd study sample (i.e., using discovery and replication samples or using additional data collection waves) or using an independent sample ( table ) . as the abcd study makes advances in our understanding of risk and resiliency factors associated with psychopathology, it will be critical for researchers to begin to translate these findings into screening and intervention advances. this work was supported by national institute on drug abuse grant u da (dmb) and national institute of health grants t mh and l mh - (nrk). the authors declare no competing interests. nrk and dmb jointly developed an outline. nrk drafted the paper and dmb provided critical revisions and table information. all authors approved the final version of the paper for submission. publisher's note springer 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genetic and shared environmental selection gene-environment interaction in psychological traits and disorders the impact of gene-environment interaction on alcohol use disorders polygenic risk scores in clinical psychology: bridging genomic risk to individual differences key: cord- -s pnm wv authors: ashikalli, louicia; carroll, will; johnson, christine title: the indirect impact of covid- on child health date: - - journal: paediatr child health (oxford) doi: . /j.paed. . . sha: doc_id: cord_uid: s pnm wv since the detection of covid- in december , the rapid spread of the disease worldwide has led to a new pandemic, with the number of infected individuals and deaths rising daily. early experience shows that it predominantly affects older age groups with children and young adults being generally more resilient to more severe disease ( – ). from a health standpoint, children and young people are less directly affected than adults and presentation of the disease has shown different characteristics. nonetheless, covid- has had severe repercussions on children and young people. these indirect, downstream implications should not be ignored. an understanding of the issues is essential for those who hope to advocate effectively for children to prevent irreversible damage to the adults of the future. this article reviews some of the evidence of harm to children that may accrue indirectly as a result of pandemics. it explores the physical and psychological effects, discusses the role of parenting and education, offering practical advice about how best to provide support as a health care professional. one of the 'positives' to emerge from the covid- pandemic in the uk has been a dramatic increase in the availability and use of remote consultations ( ) . driven initially by a need to protect and safeguard patients and healthcare professionals, the early experiences have shown that many routine reviews and some acute consultations can be successfully managed remotely. telemedicine or telehealth is becoming the new norm and can be used as an alternative to face-toface consultations, eliminating the risk of infection ( figure ) ( ) . any technology available such as phone and texting, email, and video, has now been employed to be able to provide therapy. by being able to employ many different means of communication, it makes telemedicine available to a greater number of patients. even so, there can still be inequalities in accessing healthcare as within different communities there is a difference in availability of communications means. it has been clear from early experience in the uk that there is a great difference in the availability of high quality internet connectivity between families which has limited the use of some approved, data-secure platforms such as attend anywhere. the issue of health disparities, the gap in access and quality of care are still present. solutions for the nhs have not been cheap. however, in the longer term these may be cost effective and eliminate some expenses e.g. travel, parking for families. some aspects of routine care for children have been hampered. the significant reduction in availability of lung function testing for children with chronic respiratory diseases is a concern. in some instances, these have been partially overcome with provision of home testing with either peak flow meters or portable spirometers which allow more nuanced care and advice to be given ( ) . engaging the public in planning and decision making, together with educating parents and children efficiently, has proven useful when implementing public health strategies ( ). some strategies appear to have an evidence base. for instance it is suggested that social distancing might be more adhered to if public health officials portray it as an act of altruism, giving a sense of duty to protect the child's loves ones ( ) . the direct approach may also be helpful and has certainly been tried. for example, the canadian prime minister specifically thanked children for their efforts which could only be accounted as an act to increase the feeling of social duty to the youth ( ). the universal use of face masks and the inclusion of younger children within any guidance is still being debated. when it comes to children there are more issues to consider including the availability of masks of different sizes to fit well on the face as well as the risk of suffocation in children younger than two years ( ) . additionally, when it comes to younger children, it is more challenging to persuade them not to take the mask off. innovative ideas have started to emerge, with disney designing fabric face masks with the children's favourite characters to help children in accepting to use them ( ) . whilst initial data does not suggest that children with comorbidities are at particularly increased risk of severe covid- disease ( ) ( ) ( ) , the challenge of maintaining a good continuity of care for existing patients and adequate diagnostic care for children presenting for the first time remains. children with chronic diseases and their carers have been particularly anxious about the impact that covid- could have on them. this can be partially resolved for many by maintaining communication with these families, providing reassurance, advising on hygiene measures, and educating on covid- . where children fall outside clear guidelines, tailored and individualised plans offer reassurance for all of those involved with the provision of care. at the start of this pandemic in the uk the advice given to the families with children with many chronic diseases was to shield the whole household to prevent the risk of severe illness. in hindsight, some of the advice was unduly cautious but faced with uncertainty public health authorities, paediatricians and primary care physicians erred on the side of caution. for some families, the increased anxiety may have longer term consequences. the act of shielding can have severe impacts on a child's physical and mental health. for example, going back to school could be beneficial for children with cerebral palsy or musculoskeletal problems as school provides developmental support and gives access to therapies. as ongoing research suggests a low disease severity amongst the young and the negative effects of shielding, experts questioned whether shielding children with many comorbidities was ever justified. this led to the reformation of the strict guidelines. with social distancing rules being slowly lifted and school re-opening, the rcpch has provided new guidelines for shielding ( ) . one of the medical sectors highly affected by the pandemic is the emergency department (ed) ( ) . normally, in the uk the emergency services are unnecessarily overused, leading to overcrowding and stretching of resources particularly during weekends and evenings. however, regional data suggests that there was a decrease of more than % in the cases of children presenting to the paediatric ed by march and this decline in activity has been maintained into the summer. this has certainly helped to prevent services from being deluged and allowed time for new processes and health protection procedures to be put in place. whilst this change in behaviour could discourage unnecessary attendance to ed, it could also put at greater risk children with serious pathologies that require treatment. in the uk, safeguarding has always been an important concern ( ). during a time of a global pandemic, where focus is on the direct results of the disease, vulnerable children experiencing maltreatment and neglect at home are put on the side-line. long home confinement, together with frustration, agitation, and aggression, creates opportunities to harm children. moreover, the loss of the safety net provided by schools, social care and health professionals decreases the number of abuse cases reported. without spotting narratives or signs of abuse, home becomes a very dangerous place for the vulnerable children. unfortunately, there is a trend of increasing incidences of domestic violence and calls to child support lines reported ( ) . children and teenagers exposed to violence, either as witnesses or victims could experience detrimental effects on their physical and mental health. incomplete immunisation has always been a worrying issue and unfortunately, during a pandemic, this issue can be easily neglected. this could expose communities at risk of an outbreak of a vaccinepreventable disease. for this reason, the who have declared immunisation as a core health service that should be safeguarded and conducted under safe conditions. consequently, they have prepared documents that explain the reasoning behind this and respond to any questions the public or health authorities might have. ( , ) . in recent years, weight gain during periods of school closure, especially during summer vacations, has been a worrying issue amongst the paediatric community ( ) . when comparing behaviours during summer and school season, accelerated weight gain is observed during the summer holidays ( ) . a school closure during a pandemic is not equivalent to summer vacations. nonetheless, there are distinct similarities such as the lack of structure during the day, the increase in screen time and a change in sleeping routines ( figure ). in fact, a small longitudinal observational study conducted in verona italy during this pandemic, has shown that the unfavourable trends in lifestyle discussed above, were observed amongst obese children and adolescents ( ) . the covid- pandemic has further risk factors that might exacerbate the epidemic of childhood obesity ( ) . firstly, as out-of-school time has increased more than a regular summertime, it has increased the period that children are exposed to obesogenic behaviours. secondly, parents are stocking up shelves with highly processed and calorie dense food. this action is justified by the need to maintain food availability and minimise the number of trips outside. this, however, exposes children to higher calorie diets. thirdly, social distancing and stay-at-home policies introduce the risk of decreasing opportunities for physical activity. school physical activities were removed, playgrounds could not be kept clean, parks closed their gates, community centres offering afterschool programs shut their doors. children living in urban areas, confined within small apartments are at a greater risk of adopting a sedentary lifestyle. lastly, there has been an increasing trend on the use of video games which counts as a sedentary activity and leads to excessive screen use ( ). this obesogenic behaviour needs to be taken seriously and tackled as it could have profound consequences which are not easily reversible. moreover, we should have in mind that adult obesity and its comorbidities are associated with covid- mortality ( ) , which raises the question whether overweight or obese children will have more severe repercussions upon contracting covid- . therefore, there is a need to maintain a structured day routine for the children which includes playtime and exercise time, a restriction on calories, a regular sleep pattern and supervision of screen time ( figure ). although emphasis is given to the obesogenic effects of the pandemic, there is also the issue of malnourishment as many students rely on school meals. in fact, school meals and snacks could represent up to two thirds of the nutritional needs in children in the usa ( ) . in addition to not receiving the appropriate nutrition through school, children could be exposed to cheaper, unhealthy food choices. in the uk a partial safety-net has been established and maintained over the summer period following a successful campaign by the english footballer, marcus rashford ( ) . this will offer some support to children who already received free school meals. however, not all children in the uk and many others worldwide will be protected. insecurity over food availability causes longterm psychological and emotional harm to the children and parents. a collaboration amongst who, unicef and ifrc has provided comprehensive guidance to help protect schools and children, with advice in the event of school closure and for schools that remained open ( ) . important points in this guidance document are the emphasis given to a holistic approach towards children by tackling the negative impacts on both learning and wellbeing and to educate towards covid- and its prevention. even so, these guidelines can only be considered as checklists and tips for each government to use accordingly. china provided a successful example of an emergency home schooling plan ( ) , where a virtual semester was delivered in a well organised manner through the internet and tv broadcasts, yielding satisfactory results. however, digital learning is an imperfect system that brings to the surface the inequalities caused by poverty and deprivation. many children have had either limited, shared or no online access either as a result of a lack of equipment (laptops or tablets) or internet access. some parents struggled with the provision of adequate supervision. this issue was significantly more challenging for parents with additional educational needs e.g. adhd or learning difficulties, for those with many children of different ages and for those children who might have additional carer responsibilities. it was also much more difficult for parents who were being expected to work from home at the same time. the full effects of a temporary 'pause' in many children's education in the uk remain to be seen but the effects are likely to widen the gap between children from more deprived backgrounds. since the beginning of the st century, there have been several major disease outbreaks including the severe acute respiratory syndrome (sars) in , the h n influenza pandemic in and the ebola in . however, mental health research was largely overlooked. the absence of mental health services during previous pandemics increased the risk of psychological distress to those affected ( ) . there are variable psychological manifestations as a result of a pandemic. early childhood trauma can affect a child in many ways ( ) . it can increase the risk of developing a mental illness and it can also delay developmental progress. moreover, early childhood trauma in the form of adverse childhood experiences (aces) can have profound effects that manifest in later life such as an increase in substance abuse and problems with relationships or education as well as increase the risk of chronic diseases such as asthma, obesity and attention deficit hyperactivity disorder ( ) . about % of isolated or quarantined children during the h n pandemic in the united states of america met the criteria for post-traumatic stress disorder (ptsd) ( ) . this study noted the lack of professional psychological support to these children during or after the pandemic. out of the much smaller percentage of children that did receive input from mental health services, the most common diagnoses were anxiety disorder and adjustment disorder. moreover, the same study also showed that one quarter of parents would also fulfil the criteria for ptsd which shows that parental anxiety and mental health can be reflected upon other members of the family including the children. events and conditions can have effects on our physical and mental health. these act as stressors or triggers and can predispose anyone, including children to adverse responses; either physical or psychological. the stressors that could impact a child during a pandemic are shown in figure . the duration of the lockdown appears to be particularly important. researchers have shown that the longer the quarantine, the higher the chances of mental health issues emerging in adults. it is unknown whether the same applies to children ( ) . some children and young people (cyp) will be more vulnerable to the adverse consequence of any stressors and these pre-pandemic predictors should also be considered. in a child, such predictors could include the age of the child and a history of mental illness. there is a complex link between mental health and social background. families with lower incomes face tough choices about how to cope with the day-to-day challenge of providing basic necessities (e.g. food, clothing and heating) and may be less able to give priority to the mental health of their children (or themselves). when considering what can influence mental health, the link between physical and mental health should also be considered. the physical health of a child can be affected either directly or indirectly by covid- . this raises the question of how this could affect the psychological wellbeing too and if it would lead to a vicious cycle. the sudden advance in telemedicine in the uk has been one of the unexpected changes brought about by covid- . it has been helpful in maintaining some health care for physical ailments ranging from acute illness to review of children with chronic conditions like asthma, diabetes and cystic fibrosis. it can also be used for psychological counselling for parents or children. this can help children learn how to cope with mental health problems via professional help within the security of their own house ( ) . telemedicine for mental health is already established in some countries. the psychological crisis intervention, is a multidisciplinary team program developed as a collaboration amongst a few chinese hospitals that uses the internet to provide support ( ) . telemedicine is most probably not sufficient in managing and providing for the mental health needs of the high numbers affected. when the already limited access to trained professionals is struck by a global pandemic, the shortage of professionals and paraprofessionals becomes noticeable and therefore the needs of the high number of patients are not met ( ) . when dealing with mental health a hierarchal and stepwise approach that starts in the community is helpful ( figure ). integration of behavioural health disorder screening tools within the response of public health to a pandemic is crucial to cope with demand. these should recognise the importance of identifying the specific stressors and build on the epidemiological picture of each individual to identifying those cyp at greatest risk of suffering from psychological distress ( ) . following the correct identification of patients in the community, the next step involves an appropriate referral. interventions can vary according to the individual's presentation and can include psychoeducation or prevention education. any behavioural and psychological intervention should be based on the comprehensive assessment of that patient's risk factors ( ) . for instance, researchers have shown that specific patient populations such as the elderly and immigrant workers may require a tailored intervention ( , ) . this hypothesis could therefore be stretched to children and teenagers as their needs are different to adults. the rapid changes that both parents and children are forced to face and the uncertainty of an unpredictable future have been compared to the loss of normalcy and security that palliative care patients are faced with and paediatric palliative care teams may be well-placed to provide psychological support to families ( ) . community organisations have a significant role to play in addressing mental health problems. they empower communities and provide tailored support. when this support comes from organisations which understand the community, the community's beliefs are embodied within the programs offered. it is therefore becoming obvious that best results will only be yielded if different bodies work together. this stresses how crucial it is to maintain good communication between community health services, primary and secondary care institutions. this is to ensure patients receive a timely diagnosis and better follow-up ( ) . conversely, poor communication could delay meeting the needs of the patients. the internet is a potentially useful tool for the provision of mental health support. there are a lot of reliable resources online that anyone could use effectively without being in direct contact with professionals. large organisations such as unicef have provided online documents to help teenagers protect their mental health during the pandemic. many books about the current pandemic and its psychological impact are being released electronically for free for the public ( ) . likewise, online self-help interventions such as cbt for depression can be used by anyone experiencing such symptoms. this type of intervention and signposting of lower risk cyp and families to safe, well-constructed resources is highly efficient, allowing mental health professionals to focus more intensive interventions on higher risk individuals. the online world is more easily accessible and much more appealing to older children and teenagers. as young people are becoming the experts of this virtual world, it is only logical to use social media for our benefit. successful mental health campaigns in the past used hashtags on social media like instagram and twitter to increase awareness of mental health problems ( ) . with more bloggers and social media influencers talking about mental health, together with the use of hashtags, the societal benefits become apparent. a strong feeling of empowerment is built that helps combat the stigma of mental health. moreover, there is a therapeutic benefit through the provision of information on how to find professional support or self-management strategies. even though online gaming can have negative impacts on young people's physical health, during a period of home confinement, it provides a mean for friends to stay in contact. both online gaming and the yet extensive use of social media have the potential of bringing people closer together and gives a feeling of solidarity. regarding young children, using online resources on their own might not be an easy task, although they are surprisingly becoming experts of the web too. nonetheless, there are many resources designed with the purpose to explain the pandemic to children and alleviate their anxiety as well as promoting good hygiene. a good example is the collaboration of sesame street with headspace, a mindfulness and meditation company, to create youtube videos that help young children tackle stress and anxiety. parents, carers, or older siblings could all help the young ones to access these resources. the power of technology and the artificial world is becoming a turning point for societies today. interestingly, an artificial intelligence program has been created with the purpose of identifying people with suicidal ideations via scanning their posts on specific social media platforms. once identified, volunteers take appropriate steps to help these individuals. during a time of extensive home confinement, where the use of the web becomes even more prominent, such programs might again provide a service to society by identifying teenagers struggling with mental health ( ) . healing through creative expression is a popular tool amongst child therapists and is has proven useful in previous pandemics too ( ) . during the ebola break, a dynamic art program was established for liberian children. it focused on how therapeutic expressive arts could teach coping skills and build healthy relationships in a safe and supportive space for children to express themselves and experience healing; interventions that showed positive results early on. the advantage of art programs like this is that once they are built by mental health professionals and child health specialists, they can be delivered in the communities using paraprofessionals who receive appropriate training. this allows the projects to be implemented at a wider area while more children benefit from. parents should provide a core pillar of support for children, with school and teachers, the rest of the family and friends providing robust supporting pillars. with home confinement, these supporting pillars break down and the parent becomes the only resource for a child to seek help from. when the wellbeing of the child is at risk, it is important for parents to monitor the children's behaviours and performance. open communication is necessary to identify any issues; physical or psychological. having direct conversations about the pandemic can prove useful in mitigating their anxiety. a common notion is for parents to shield their children from bad news to protect them. it is true that most of the information about the pandemic that children are exposed to is not directed to them and it hence becomes overwhelming. however, children will still ask important questions and ask for satisfactory answers. shielding the world from them is not the right answer. parents should practice active listening and responding appropriately to any questions the child might have as well as adapting their responses to the child's reactions. narrating a story or encouraging the child to draw what is on their mind might enable the start of a discussion. attention also needs to be given to any difficulties sleeping and the presence of nightmares as it could be a sign that the child is not coping well. although strict monitoring of behaviours is required, it is a very delicate issue and it should not put the child into an uncomfortable position. with daily home confinement, it is important to respect the children's privacy and identity. whilst it may seem overwhelming to families to provide all the information required to children there are already many reliable resources available online about how best to maintain the health and wellbeing of their children through this pandemic. unicef has provided online resources for parents to use with emphasis given on how to talk to a child about the pandemic and provide comfort. similarly, the who have also provided a series of posters on parenting during the pandemic again with the purpose of promoting the wellbeing of children. parents and carers are often portrayed as superheroes. however, even these superheroes may experience anxiety and fear during a pandemic. the psychological health of parents and their children seem to be inextricably linked and ptsd is commoner in children whose parents are experiencing it too ( ) . as parents with poorer mental health might not be able to respond to the needs of their children effectively, then addressing this is important. alleviating their stressors will help improve mental health. priority should be given in ensuring that the basic needs of these families are met, including food provisions, financial support, and healthcare access. once these are provided, there are higher chances that any psychological support can have a positive effect on parents. such support can have multiple different dimensions and various tools can be utilised. such tools should be easily accessible, put to practice quickly and aim to strengthen mental resiliency. for instance, behavioural practitioners are suggesting the use of acceptance and commitment therapy ( ). anecdotally the consequence of a prolonged period of lockdown for some families in the uk has been a positive one. home confinement can benefit interactions and help children to engage in family activities. this may help strengthen family bonds and meet the psychological needs of a developing mind. collaborative games fight loneliness and strengthen family relations. other activities that families could do together include learning new skills like cooking or taking up new hobbies like building puzzles. researchers have also shown that during the brief school closure due to the a/h n influenza pandemic in , as time went by, parents became more prepared and started planning more activities. this gave more reasons to young people to stay at home and helped in encouraging social distancing; which proved harder at the start of the influenza pandemic ( ). the impact of the covid- pandemic goes beyond the risk of a severe acute respiratory response. it has posed severe social and economic consequences worldwide. children and young people have been exposed to very severe repercussions which if not addressed, could have even worse outcomes in the future. therefore, governments, communities, non-governmental organisations and healthcare professionals need to work in collaboration to prevent causing irreversible damage to a generation. systematic review of covid- in children shows milder cases and a better prognosis than adults covid- epidemic: disease characteristics in children covid- in children: initial characterization of the pediatric disease european and united kingdom covid- pandemic experience: the same but different promoting and supporting children ' s health and healthcare during covid- -international paediatric association position statement managing asthma during covid- : an example for other chronic conditions in children and adolescents including the public in pandemic planning: a deliberative approach the psychological impact of quarantine and how to reduce it: rapid review of the evidence prime minister appeals to canadian children to follow social distancing rules | cbc news to mask or not to mask children to overcome covid- disney creates fabric face masks for children | daily mail online challenges in chronic paediatric disease during the covid- pandemic: diagnosis and management of inflammatory bowel disease in children new clinical needs and strategies for care in children with neurodisability during covid- covid- is no worse in immunocompromised children, says nice covid- -'shielding' guidance for children and young people where have all the children gone ? decreases in paediatric emergency department attendances at the start of the covid- pandemic of child health in in england : comparisons with other wealthy countries. r coll paediatr child heal isolated at home with their tormentor": childline experiences increase in calls since closure of schools guiding principles for immunization activities during the covid- pandemic frequently asked questions ( faq ) immunization in the context of covid- pandemic understanding differences between summer vs. school obesogenic behaviors of children: the structured days hypothesis lockdown on lifestyle behaviors in children with obesity living in covid- -related school closings and risk of weight gain among children telehealth solution for vulnerable children with obesity during covid- feeding low-income children during the covid- pandemic covid- : ifrc, unicef and who issue guidance to protect children and support safe school operations mitigate the effects of home confinement on children during the covid- outbreak recommended psychological crisis intervention response to the novel coronavirus pneumonia outbreak in china: a model of west china hospital playing to live: outcome evaluation of a community-based psychosocial expressive arts program for children during the liberian ebola epidemic adverse childhood experiences: assessing the impact on physical and psychosocial health in adulthood and the mitigating role of resilience posttraumatic stress disorder in parents and youth after health-related disasters online mental health services in china during the covid- outbreak. the lancet psychiatry psychological interventions for people affected by the covid- epidemic. the lancet psychiatry a nationwide survey of psychological distress among italian people during the covid- pandemic: immediate psychological responses and associated factors mental health services for older adults in china during the covid- outbreak the neglected health of international migrant workers in the covid- epidemic applying palliative care principles to communicate with children about covid- understanding why people use twitter to discuss mental health problems behavioral and emotional disorders in children during the covid- epidemic •% of total enrolled learners: . % • country-wide closures •affected learners: , •% of total enrolled learners: % • country-wide closures •affected learners: , key: cord- - p ppawn authors: winhusen, theresa; walley, alexander; fanucchi, laura c.; hunt, tim; lyons, mike; lofwall, michelle; brown, jennifer l.; freeman, patricia r.; nunes, edward; beers, donna; saitz, richard; stambaugh, leyla; oga, emmanuel; herron, nicole; baker, trevor; cook, christopher d.; roberts, monica f.; alford, daniel p.; starrels, joanna l.; chandler, redonna title: the opioid-overdose reduction continuum of care approach (orcca): evidence-based practices in the healing communities study date: - - journal: drug alcohol depend doi: . /j.drugalcdep. . sha: doc_id: cord_uid: p ppawn background: the number of opioid-involved overdose deaths in the united states remains a national crisis. the healing communities study (hcs) will test whether communities that heal (cth), a community-engaged intervention, can decrease opioid-involved deaths in intervention communities (n = ), relative to wait-list communities (n = ), from four states. the cth intervention seeks to facilitate widespread implementation of three evidence-based practices (ebps) with the potential to reduce opioid-involved overdose fatalities: overdose education and naloxone distribution (oend), effective delivery of medication for opioid use disorder (moud), and safer opioid analgesic prescribing. a key challenge was delineating an ebp implementation approach useful for all hcs communities. methods: a workgroup composed of ebp experts from hcs research sites used literature reviews and expert consensus to: ) compile strategies and associated resources for implementing ebps primarily targeting individuals and older; and ) determine allowable community flexibility in ebp implementation. the workgroup developed the opioid-overdose reduction continuum of care approach (orcca) to organize ebp strategies and resources to facilitate ebp implementation. conclusions: the orcca includes required and recommended ebp strategies, priority populations, and community settings. each ebp has a “menu” of strategies from which communities can select and implement with a minimum of five strategies required: one for oend, three for moud, and one for prescription opioid safety. identification and engagement of high-risk populations in oend and moud is an orccarequirement. to ensure cth has community-wide impact, implementation of at least one ebp strategy is required in healthcare, behavioral health, and criminal justice settings, with communities identifying particular organizations to engage in hcs-facilitated ebp implementation. in order to promote oend, effective delivery of moud, and safer opioid prescribing the study team developed an approach to ebp implementation with utility for all participating communities, which vary widely in their current ebp implementation, access to resources including needed workforce, and perceived acceptability of various ebps. this paper describes the framework developed to guide ebp selection and implementation strategies contained in the opioid-overdose reduction continuum of care approach. for each ebp component of the cth intervention, a workgroup consisting of ebp experts from each research site was established to develop an approach that would include standardization requirements across communities, while also providing enough flexibility to meet the varying needs of the hcs communities. a significant reduction in opioid-involved overdose deaths will require widespread implementation of oend, effective delivery of moud, and prescription opioid safety efforts. therefore, effective implementation of strategies for each of these three ebps is an hcs goal. the first task undertaken by this workgroup was developing a framework for organizing the targeted ebps and potential strategies for their implementation. the opioid-overdose reduction continuum of care approach (orcca), shown in figure , was adapted from the cascades of care for oud developed by williams and colleagues . cascades of care emphasizes four domains: prevention, identification, treatment, and remission. the orcca places greater emphasis on the hcs-goal of implementing ebp strategies that will reduce opioid-involved overdose fatalities and demonstrates how overdose reduction strategies overlap across a continuum of care rather than being discrete steps. the workgroup then developed the orcca's required elements and a companion technical assistance guide referencing existing resources to assist communities with implementation. based on research literature and expert consensus, the orcca includes required and recommended community settings, priority populations, ebps, and implementation strategies. in order to ensure the cth intervention has impact across multiple sectors interacting with individuals at high risk for an opioid-involved overdose and across the care continuum, each community is required to implement at least one of the ebps within each of three community settings: j o u r n a l p r e -p r o o f ) healthcare; ) behavioral health; and ) criminal justice. healthcare settings include outpatient healthcare centers, pre-hospital providers, emergency departments and urgent care, hospitals, primary care settings, and pharmacies. behavioral health includes substance use disorder and mental health treatment centers and social service agencies. criminal justice includes pre-trial, jails, probation, parole, drug and problem-solving courts, police and "narcotics" task forces, halfway houses, community-based correctional facilities, and department of youth services. communities provide a rationale for not engaging all three community settings. most people with oud in the u.s. are not enrolled in effective treatment . any individual misusing opioids or with oud is at risk for opioid-involved overdose death, particularly if not engaged in moud. a substantial proportion of people who die from opioid-involved overdose have had no interaction with the healthcare system in the previous year (larochelle et al., ) . thus, reducing overdose deaths will require engaging people who currently are not accessing overdose prevention or oud treatment services. this reality is the justification for an orcca requirement to identify and intervene with high-risk populations. individuals who are at highest risk for overdose, such as those who have overdosed or those who recently were treated in a withdrawal management program (colloquially referred to as "detox"), do not typically access moud (larochelle et al., ; walley et al., ) . specific factors that further elevate the risk of overdose among those using opioids include: ) having had a prior opioid overdose (caudarella et al., ; darke et al., ; larochelle et al., ; larochelle et al., ; winhusen et al., ) ; ) having reduced opioid tolerance (e.g., completing medically supervised or "socially" managed withdrawal, or release from an institutional setting such as jail, residential treatment, hospital) (binswanger, ingrid a. et al., ; larochelle et al., ; merrall, e. l. c. et al., ; strang et al., ; walley et al., ) ; ) using other substances (e.g., alcohol, benzodiazepines, stimulants) (brugal et al., ; cho et al., ; gladden et al., ; larochelle et al., ; park et al., ; sun et al., ) ; ) having a concomitant major mental illness (e.g., major depression, bipolar disorder, schizophrenia, anxiety disorders) (o'driscoll et al., ; pabayo et al., ; tobin and latkin, ; wines et al., ) ; ) having a concomitant major medical illness (e.g., cirrhosis, chronic kidney disease, copd, asthma, sleep apnea, congestive heart failure; infections related to j o u r n a l p r e -p r o o f drug use) (bosilkovska et al., ; green et al., ; jolley et al., ; larochelle et al., ; vu et al., ) ; and/or ) injecting drugs (bazazi et al., ; brugal et al., ) . in developing the orcca, the workgroup delineated three approaches to identifying high risk populations (see table ). these approaches include: ) identification within criminal justice settings and venues where high-risk populations seek services malta et al., ; park-lee et al., ; suffoletto and zeigler, ; weiner et al., ) , ) field-based outreach including point-of-contact for emergency response (bagley, s. m. et al., ; waye et al., ) , and ) the use of surveillance or other existing data sources to locate individuals likely needing intervention (formica et al., ; merrick et al., ) . in the first approach, ebps are incorporated into services at venues where people at high-risk may be present. the second approach includes real-time community outreach to high-risk venues and individuals. the third approach includes identifying newly emerging risk groups utilizing overdose surveillance data. in addition to defining populations at high risk for overdose, the orcca also identifies populations that would likely warrant tailoring ebp strategy implementation. these groups include adolescents (bagley et al., ; chatterjee et al., ; lyons et al., ) , pregnant and post-partum women (goldman-mellor and margerison, ; nielsen et al., ) , homeless populations (bartholomew et al., ; doran et al., ; magwood et al., ) , rural populations without transportation (arcury et al., ; bunting et al., ) and other factors related to poverty (snider et al., ; song, ), veterans (lin et al., mudumbai et al., ) , non-english speaking and immigrant populations (salas-wright et al., ; singhal et al., ) , racial and ethnic minorities (barocas et al., ; lippold et al., ) , people with mental health disorders (turner and liang, ) and mental/physical disabilities (burch et al., ; west et al., ) , people involved in transactional sex (goldenberg et al., ; marchand et al., ) , and people who have chronic pain (bohnert et al., ; dunn et al., ; james et al., ) . as one of the hcs requirements, communities will record the high-risk populations and community venues included in the selected ebp strategies. j o u r n a l p r e -p r o o f subgroups were established for each of the three ebps to assemble strategies and resources contained in the orcca. these subgroups created a forum for networking and collaboration among investigators with specific content expertise. subgroups drafted each respective menu (oend, moud, and safer opioid prescribing) and their technical assistance guide subsections. based on the likelihood of overdose reduction, the subgroups made recommendations on which strategies should be required and which should be optional. for example, the oend subgroup recommended that "active" distribution of oend be required, because it was concluded that reducing overdose on a community level required oend being pro-actively provided to high-risk populations. it would not be enough to "passively" make it available regardless of overdose risk. each subgroup reviewed the literature and completed online searches (e.g., samhsa website) for resources and toolkits. upon completion of each subgroup's section, the full workgroup convened to vote and approve the orcca. naloxone reverses an opioid overdose if administered quickly. overdose prevention education and broad community access to naloxone is associated with reduced opioid-involved overdose death (bird et al., ; clark et al., ; giglio et al., ; mcdonald and strang, ; walley et al., b) . oend includes clear, direct messages about how to prevent opioid overdose and rescue a person who is overdosing to empower trainees to respond to overdoses. oend can be successfully implemented at multiple venues among diverse populations. the oend menu (see table ) includes three sub-menus: a) active oend, which is required; b) passive oend, which is optional; and c) naloxone administration, which is optional. the following sections describe the rationale and evidence for the oend submenus. a) active oend active oend is proactive and targeted towards high-risk populations and their social networks or venues where high risk populations are likely to be found. active oend is a required orcca menu element because the best evidence for reducing overdose via oend has been shown among communities that pro-actively make oend accessible to those at high risk for overdose (walley et al., b) including people released from j o u r n a l p r e -p r o o f incarceration (bird et al., ) , and people with chronic pain treated with chronic opioid therapy through community health centers (coffin et al., ) . opioid overdose education typically includes education about overdose risk factors and how to recognize and respond to an overdose, including naloxone administration; training can be provided in a variety of formats including in-person or on-line. active oend examples include: syringe service program workers providing oend to people who inject opioids (doe-simkins et al., ; walley et al., b; wheeler et al., ) ; emergency department staff providing oend to patients seen for opioid-use complications (dwyer et al., ; gunn et al., ) ; and equipping people released from incarceration with naloxone (bird et al., ; wenger et al., ) . passive oend increases oend access to individuals referred by other providers and those seeking oend on their own and makes naloxone available for immediate use in overdose hotspots. as an optional orcca submenu, passive oend strategies are encouraged but not required because their impact is unlikely to be adequate to reduce overdose deaths compared to active oend strategies. examples of passive oend include distributing naloxone at a community meeting or making naloxone available at a pharmacy without a prescription pollini et al., ; sohn et al., ) , for example through pharmacy standing orders (abouk et al., ; davis and carr, ; evoy et al., ; xu et al., ) . this submenu also includes publicly available naloxone for emergency use where overdoses commonly occur, such as public restrooms (capraro and rebola, ) . the naloxone administration submenu focuses on increasing capacity for opioid overdose response and rescue by first responders such as police (wagner et al., ) and fire and emergency medical technicians (davis et al., ; davis et al., a; davis et al., b; rando et al., ) . in these programs, first responders are trained in overdose response and equipped with naloxone, so they have the capacity to administer naloxone when called. they do not distribute naloxone to others in the community. this is also an optional menu item because the impact is unlikely to be adequate to reduce overdose deaths compared to active oend. . . effective delivery of moud, including agonist / partial agonist medication j o u r n a l p r e -p r o o f moud decreases the risk of opioid-involved death (larochelle et al., ; pearce et al., ; sordo et al., ) but is widely underutilized (volkow and wargo, ; williams et al., ) . barriers to improved moud utilization include inadequate treatment availability, failure to identify and engage high-risk populations in moud, and poor treatment retention (morgan et al., ; samples et al., ) . accordingly, the moud menu (table ) is composed of three sub-menus: a) expand moud treatment availability; b) interventions to link people in need to moud; and c) moud engagement and retention. it is required that communities choose at least one strategy from each of the three moud submenus. evidence for decreasing mortality is strongest for methadone and buprenorphine. therefore, communities are required to choose strategies that expand access to, and improve retention in, treatment with these medications. strategies that focus on naltrexone are optional since this medication has less evidence for reducing opioid-involved overdose (larochelle et al., ) , although clinical trials suggest extended-release injection naltrexone can be effective for relapse prevention if adherence is secured (lee et al., ; lee et al., ; tanum et al., ) . the following sections describe the rationale and evidence for the three required submenus within the moud menu. communities must select at least one strategy that expands moud treatment availability with buprenorphine or methadone from this submenu. though each potential strategy includes multiple venues, the orcca does not prescribe which venues must be included outside of the overall requirement that communities choose at least one strategy that addresses healthcare, behavioral health, and criminal justice settings across all three main menus. the first submenu strategy is adding and/or expanding moud treatment in primary care, other general medical and mental health settings and substance use disorder treatment and recovery programs. historically in the us, addiction treatment has been isolated from general medical and mental health care settings, and moud treatment has been omitted from the care provided in primary care, hospitals (fanucchi and lofwall, ; jicha et al., ) , emergency departments (hawk et al., ) , and general mental health (novak et al., ) . furthermore, according to data from the national survey of substance abuse treatment facilities, many substance use disorder treatment programs do not provide moud (substance abuse and mental health services administration, c). specifically, in , the proportion of facilities offering buprenorphine, methadone, and j o u r n a l p r e -p r o o f long-acting naltrexone treatment was %, %, and % respectively (substance abuse and mental health services administration, c). moud treatment can be successfully integrated in these settings, increasing capacity and reducing treatment barriers (blanco and volkow, ; chou, r et al., ; korthuis et al., ) . the second submenu strategy is adding and/or expanding moud treatment in criminal justice settings. despite the strong evidence base, moud is not commonly provided in criminal justice settings, with only out of , us prisons and jails offering methadone or buprenorphine in (substance abuse and mental health services administration, e). incarceration is associated with increased risk of overdose death postrelease largely due to loss of tolerance after forced withdrawal during incarceration (binswanger et al., ; merrall, e. l. c. et al., ) . improving availability of moud in criminal justice settings, including pre-trial, jail, prison, probation, and parole, is a critical opportunity to reduce opioidinvolved overdose deaths (moore et al., ). the third submenu strategy is expanding access to moud treatment through telemedicine, interim buprenorphine (sigmon et al., ) , interim methadone (newman, ; schwartz et al., ) , or medication units (office of the federal register and government publishing office, b). expanding access to moud through telemedicine is especially salient as communities consider orcca strategies during the covid- pandemic. telemedicine models for buprenorphine treatment already existed (u.s. department of health and human services, ), but guidance from the us drug enforcement agency, samhsa, the centers for medicare & medicaid services, and state regulatory agencies changed rapidly ; opioid response network, ; providers clinical support system, a; substance abuse and mental health services administration, c) to allow greater flexibility of moud treatment via telemedicine during the pandemic. for example, the requirement for an in-person visit to begin moud was waived and dispensing of medications was allowed for longer periods of time. it is unclear how effective these changes will be or whether they will remain, but telemedicine is part of the oud treatment landscape and an important tool to support treatment access. "interim" treatment with methadone or buprenorphine refers to treatment with medication dispensed directly to patients (no prescription given) at licensed opioid treatment programs, which are heavily regulated at a federal and state level and require comprehensive ancillary services (e.g., on-site counseling). when there j o u r n a l p r e -p r o o f are waiting lists, these programs may receive regulatory approval to provide medication for up to days while patients await the full array of nonmedication services. this is called "interim" treatment and is superior to waiting lists on multiple outcomes including illicit opioid use and treatment retention (sigmon, ) . a medication unit is a satellite to a licensed opioid treatment program providing primarily medication dispensing in order to make treatment more accessible to patients (office of the federal register and government publishing office, b). new patients are required to have direct supervision of their daily dispensed medication for the first days of treatment, making travel a barrier to treatment if the program is located far away from the patient. therefore, medication units are a way to extend the availability of methadone treatment over a wider geographic region. the second submenu focuses on strategies that link people with oud to moud. there are two strategies to choose from: improving linkage to moud from venues where persons with oud may be encountered (e.g., general medical and mental health treatment programs, syringe service programs, and criminal justice settings); and using moud initiation as a bridge to longer-term care (starting moud at the venue where the patient is encountered in addition to linkage to ongoing moud treatment). on-site moud initiation strategies are preferred and can occur across multiple community-based settings such as in emergency departments and hospitals where patients may present with complications of untreated oud such as an opioid overdose or a deep-seated infection related to intravenous injection of opioids. starting moud in these venues is safe, feasible, and can significantly increase likelihood of continuing moud treatment (d'onofrio et al., ; weinstein et al., ) . c) moud treatment engagement and retention moud treatment retention beyond months is challenging (samples et al., ) , but critical to saving lives. research is clear that moud treatment retention is strongly associated with decreased mortalityboth from overdose and all-cause mortality, with risk of overdose increasing dramatically after discontinuation of moud (pearce et al., ; wakeman et al., ; walley et al., ; williams et al., ) . communities must choose at least one of the following five strategies: a) enhancement of clinical delivery approaches to support engagement and retention; b) use of j o u r n a l p r e -p r o o f virtual retention approaches; c) retention care coordinators; d) mental health and polysubstance use treatment integrated into moud care; and e) reducing barriers to housing, transportation, childcare, and accessing other community benefits for people with oud. comprehensive strategies to improve moud treatment retention include addressing each individual's treatment needs, which commonly include treatment for comorbid mental health and non-opioid substance use disorders as well as reducing barriers to resources such as housing, transportation, insurance coverage, food security, childcare, employment and other psychosocial and community services (substance abuse and mental health services administration, d). shared decision making, case management, legal assistance and advocacy, on-site psychiatric services and psychosocial recovery support, insurance navigation, behavioral interventions such as contingency management for comorbid non-opioid substance use disorders (de crescenzo et al., ) , and technology-delivered therapies (christensen et al., ) are some example strategies aimed at improving engagement and retention. opioid analgesic prescribing practices can increase the risk of long-term opioid use, the development of oud and opioid-involved overdose deaths. for example, an opioid analgesic prescription is associated with increased risk for oud in persons with chronic non-cancer pain (edlund et al., ) and the length of an initial opioid prescription for acute pain is a significant predictor of long-term use (shah et al., ) . similarly, high doses of opioids (e.g., > morphine milligram equivalents) (bohnert et al., ; dasgupta et al., ) , use of extended-release/long-acting opioids (zedler et al., ) and concurrent prescribing of benzodiazepines increase the risk of overdose (hernandez et al., ; sun et al., ) . those with cooccurring mood disorders, other non-opioid substance use disorders, chronic medical conditions, and chronic pain are at heightened risk (campbell et al., ) . when prescribed opioids are not properly stored or go unused, the excess supply is a potential source for non-medical use and/or diversion; the majority of persons reporting non-medical use of prescription opioids obtain them from a friend or family member (substance abuse and mental health services administration, a). numerous safer opioid prescribing guidelines have been published (chou et al., ; franklin and american academy of, ; manchikanti et al., ; nuckols et al., ) , however, adherence to these guidelines is low (hildebran et al., ; sekhon et al., ; starrels et al., ) . pain management education remains inadequate (mezei et al., ) , but is a key strategy to address poor adherence to j o u r n a l p r e -p r o o f guideline-based safer opioid prescribing practices. accordingly, the prescription opioid safety menu (table ) includes two submenus: a) safer opioid prescribing/ dispensing practices, which is required, and b) safer opioid disposal practices, which is optional. a) safer opioid prescribing/dispensing practices communities must select at least one of the following three strategies: ) safer opioid prescribing for acute pain across healthcare settings, such as inpatient services, emergency departments, outpatient clinics, ambulatory surgery and dental clinics; ) safer opioid prescribing for chronic pain, including adherence to the cdc guideline recommendations and patient-centered opioid tapering; or ) safer opioid dispensing. a variety of approaches have been effective in promoting safer opioid prescribing. for example, opioid prescribing changes were observed following implementation of the cdc chronic pain guidelines (bohnert et al., ) . online and in-person continuing education has been shown to improve knowledge, attitudes, confidence and self-reported clinical practice in safer opioid prescribing (alford et al., ) . academic detailing, an interactive one-on-one educational outreach by a healthcare provider to a prescriber to provide unbiased, evidence-based information to improve patient care, has been applied successfully to improve opioid prescribing behavior (larson et al., ; voelker and schauberger, ) . the utilization of state prescription drug monitoring programs to assess patients' controlled substance prescription histories and identify potential risky patterns of opioid use or drug combinations has resulted in reduced multiple-provider episodes (i.e., "doctor shopping") (strickler et al., ) , reduced high-risk opioid prescribing (strickler et al., ) , and reduced prescription opioid poisonings (pauly et al., ) . prescriber feedback regarding a patient's fatal overdose can also change prescriber behavior (doctor et al., ; volkow and baler, ) . most efforts to promote safer opioid analgesic use have focused on prescriber behavior change. however, pharmacists are the last line of defense against unsafe opioid prescriptions and have a corresponding responsibility to ensure legitimate prescriptions (office of the federal register and government publishing office, ). providing safe, convenient, and environmentally appropriate ways to dispose of unused prescription opioids can help reduce the excess opioid supply within communities and prevent access by children, adolescents, and other vulnerable individuals. communities have the option of selecting a j o u r n a l p r e -p r o o f strategy to promote safe disposal practices such as the installation of permanent disposal kiosks or the implementation of other disposal programs such as distribution of drug mail-back envelopes. studies have shown that leftover medication from an opioid prescription is common (bicket et al., ; kennedy-hendricks et al., ) and that patient education regarding disposal practices can increase opioid disposal rates (hasak et al., ) , although education about disposal is suboptimal (gregorian et al., ) . according to a recent study, only % of persons who had received an opioid prescription in the previous two years disposed of their unused opioid medication; however, over % indicated they would be more likely to dispose of opioid medications in the future if disposal kiosks were in a location they visited frequently (buffington et al., ). because the evidence base will evolve during the course of this study, additional strategies can be added to the menus if any of the following inclusion criteria are met: ) listed in a registry of ebps (federal, state, or community) that documents it has been replicated multiple times with positive effects; ) evidence of its efficacy through, at a minimum, a quasi-experimental design; ) evidence of its efficacy in reducing opioid-involved overdose death that has been published in a scientific journal; or ) it has been reviewed and approved by the orcca steering committee. upon completion of the orcca menus, the subgroups developed a companion technical assistance guide which provides greater detail about the resources included in the orcca menus (i.e., the resources listed in the "sample resources" column of tables - ). the resources compiled in the guide (e.g., toolkits, publications, websites) are designed to help implement and sustain each ebp and strategy included on an orcca menu and provides examples of successful national, state, and local programs. the guide is considered a "living document" and is updated every six months by a dedicated subgroup spanning the research sites. the hcs seeks to facilitate widespread uptake and expansion of three ebps with the potential to reduce opioid-involved overdose fatalities: ) oend; ) effective delivery of moud, including agonist / partial agonist medication; and ) prescription opioid safety. this paper described the j o u r n a l p r e -p r o o f development of the orcca, which includes a menu-based approach to organizing strategies and resources for facilitating implementation of these ebps. the orcca includes requirements and recommendations for ebp implementation to help ensure standardization across the research sites. at minimum, five strategies need to be selected to implement the three ebps: one for oend, three for moud, and one for prescription opioid safety. based on a literature review and expert consensus, the orcca requires identification, and engagement of, high-risk populations in healthcare, behavioral health, and criminal justice settings, which will help ensure both that individuals most in need of services receive them and that implementation of ebps will be more widespread in communities than could be achieved by allowing implementation within a narrower range of settings. importantly, the orcca does not prescribe the implementation of any single strategy; rather, it provides flexibility with multiple strategy options for implementing the required ebps, all of which were chosen based on the scientific evidence. because each community will vary in the need, feasibility, readiness, desirability, stage of current implementation, and expected impact for specific practices, they will likely differ in their strategies and venues for implementing the three required ebps. many of the resources included in the orcca menus and technical assistance guide have been developed to directly assist community coalitions, implementation teams, administrators, and practitioners who seek to implement or expand ebps. in the hcs, the implementation of selected strategies will be a partnership between the community coalitions and the research site team, with the research site providing technical support. a limitation of the approach taken to orcca development is that a formal systematic review of the literature, such as that outlined by the preferred reporting items for systematic reviews and meta-analyses (moher et al., ), was not completed and, thus, potential strategies that could effectively support ebp implementation may have been missed. a strength of the approach is that, in addition to meeting the needs of the hcs communities, the orcca was designed for dissemination to other communities struggling with the opioid crisis should the hcs model prove effective. the flexibility included in the orcca, along with the resources included in the orcca menus and the technical assistance guide, will increase the ease of implementation, with knowledgeable clinical experts in place of a research team, who partner with coalitions and organizations to select and implement practices that will achieve desired outcomes and foster sustainability. o single-item drug screening question (smith et al., ) o taps tool (tobacco, alcohol, prescription medication and other substance use) (mcneely et al., b; schwartz et al., ) o rapid opioid dependence screen (rods) (wickersham et al., ) o prescription drug monitoring program systems (huizenga et al., ) o o police assisted addiction recovery initiative o relay, a peer-delivered response to nonfatal opioid overdoses (welch et al., ) o recovery initiation and management after overdose (scott et al., ; scott et al., ) o j o u r n a l p r e -p r o o f oend by referral (e.g. prescription to fill at pharmacy guy et al., ; mueller et al., ) , referral to oend dispensing program (coffin et al., ; sohn et al., ) general resources/toolkits for oend by referral and oend by self-request o prescribe to prevent (lim, j. k. et al., ; prescribe to prevent, ) o getnaloxonenow.org training (simmons et al., ) o prevent & protect: pharmacy outreach to improve community naloxone access (prevent and protect, ) o oend self-request (e.g. at pharmacy, community meeting or public health department) (jones et al., ) naloxone availability for immediate use in overdose hotspots (naloxbox, ; salerno et al., ) naloxbox (mounted supply of naloxone) (naloxbox, ) (clark, l et al., ; samhsa-hrsa center for integrated health solutions, ) safer opioid prescribing for chronic pain (barth et al., ; bohnert et al., ; bohnert et al., ; dunn et al., ; edlund et al., ; gaiennie and dols, ; gomes et al., ; guy et al., ; jeffery et al., ; liebschutz et al., ) pain management guidelines and toolkits association between state laws facilitating pharmacy 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disabilities: accessibility concerns opioid overdose prevention programs providing naloxone to laypersons -united states validation of a brief measure of opioid dependence: the rapid opioid dependence screen (rods) developing an opioid use disorder treatment cascade: a review of quality measures acute care, prescription opioid use, and overdose following discontinuation of long-term buprenorphine treatment for opioid use disorder drug and opioid-involved overdose deaths-united states overdose after detoxification: a prospective study development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (ttip-pro) hhs guide for clinicians on the appropriate dosage reduction or discontinuation of long-term opioid analgesics community management of opioid overdose the opioid overdose epidemic: opportunities for pharmacists treatment utilization among persons with opioid use disorder in the united states opioids prescribed after low-risk surgical procedures in the united states state naloxone access laws are associated with an increase in the number of naloxone prescriptions dispensed in retail pharmacies utilizing risk index for overdose or serious opioid-induced respiratory depression (riosord) scores to prioritize offer of rescue naloxone in an outpatient veteran population: a telephone-based project initiation of buprenorphine during incarceration and retention in treatment upon release risk factors for serious prescription opioidrelated toxicity or overdose among veterans health administration patients • providers clinical support system sud curriculum (providers clinical support system • comparative effectiveness of different treatment pathways for opioid use disorder (wakem • clinical guidelines for use of depot buprenorphine in the treatment of opioid dependence (n • providers clinical support system primer on antagonist-based treatment of opioid use diso support system clinical use of extended-release injectable naltrexone in the treatment of opioid us and mental health services administration state targeted response technical assistance c (american academy of addiction psychiatry and state targeted response technical assistanc • project echo practitioner locator (substance abuse and mental health services a american society o • harvard medical school free, accredited online courses in opioid use disorder education ○ understanding addiction ○ identification, counseling, and treatment of oud ○ collaborative care approaches for the management of oud expanding the use of medications to treat individuals with substance use disorders • procedures for medication-assisted treatment of alcohol or opioid dependence in primary c • getting started with moud with lessons from advancing recovery medications for oud (substance abuse and mental health services admin • samhsa mat guide for pregnant women with oud (substance abuse and mental health • samhsa tip : substance abuse treatment for persons with co-occurring disorders association: the opioid guide integrating buprenorphine treatment for oud in primary care • providers clinical support system overview of medication assisted treatment (providers cli • provider clinical support system mentoring program (providers clinical support system california department of health care services, ) and project "support shout and california health care foundation buprenorphine home induction smart phone application • national institute on drug abuse home induction guide • continuum of care echo: inpatient treatment programs and methadone providers office based addiction treatment clinical guidelines (boston medica • american college of emergency physicians addressing the opioid stigma in the initiating buprenorphine treatment in detoxification settings • association between mortality rates and medication and residential treatment • institute for health and recovery maternal opioid use during pregnancy toolkit (institute for quality collaborative • adolescent substance use and addiction program -primary care • integrating bup treatment in hiv primary care settings (target hiv intensive course series continuing medical education on controlled substance pr state-specific resources o kentucky • find help now kentucky (locate addiction specialty clinics) (find help now ky the massachusetts substance use helplin • journey recovery project pregnancy and parenting (journey recovery project • massachusetts health hospitals association guideline treating opioid use disorder in the e hospital association • protecting others and protecting treatment  national commission on correctional healthcare jail-based medication-assisted treatment: p resources for the field (national commission on correctional healthcare use of medication assisted treatment for opioid use disorder in criminal justice services administration medication assisted treatment in the criminal justice system: brief guidance to t health services administration  california health care foundation medication-assisted treatment in county criminal justice foundation principles of drug abuse treatment for criminal justice populations-a research-based guide  protocol for consent to treatment with medications for opioid use disorder in correctional f addiction services, ) expanding access to moud treatment through telemedicine, interim buprenorphine or methadone, or medication units  medication units: electronic-code of federal regulations - . (office of the  interim methadone: electronic-code of federal regulations - support for hospital opioid use treatment" webinar on telemedicine and moud t health care foundation linkage programs (all relevant settings) within (or initiated within) service settings • massachusetts post-overdose public health -public safety partnerships now what? the role of prevention following a nonfatal opioid overdose • police assisted and addiction recovery initiative • community reinforcement and family training (center for motivation and change • the minute guide • the foundation for opioid response efforts (foundation for opioid response efforts within outreach/field settings • colerain (cincinnati) quick response teams • safety and health integration in the enforcement of laws on drugs • harmonizing disease prevention and police practice model access to recovery (massachusetts access to recovery, ) peer navigation • ohio mental health & addiction services: peer recovery support • recovery coach academy (friends of recovery • providers clinical support system (providers clinical support system, a) and addicti interviewing training referral only • samhsa/hrsa three strategies for effective referrals to specialty mental health and for integrated health solutions review of post opioid overdose interventions in preventative medicine (bagl starting individuals on moud as an adjunct to linkage programs (all relevant settings within (or initiated within) service settings • samhsa tip : medications for oud (substance abuse and mental health services admin • california bridge (california department of use of medication assisted treatment for opioid use disorder in criminal justice services administration principles of drug abuse treatment of criminal justice populations: a research-based guid clinical use of extended-release injectable naltrexone in the treatment of opioid us and mental health services administration opioid response network (american academy of addiction psychiatry and state targeted re • harm reduction agencies as potential site for buprenorphine treatment addiction consultation services -linking hospitalized patients to outpatient addiction treatme • a transitional opioid program to engage hospitalized drug users ) c) moud treatment engagement and retention (required) retention use of psychosocial interventions in conjunction with medications for clinical support system with community reinforcement approac incentives (center for the application of substance abuse technologies use of virtual retention approaches (e.g., mobile, web, digital therapeutics) (pear therapeutics, ; substance abuse and mental health services administration • reset® prescription digital therapeutic software (pear therapeutics computer-based training for cognitive behavioral therapy (carroll • connections smartphone app program reviews (center for technology and b utilize retention care coordinators • samhsa: wraparound implementation and practice quality standards hiv care coordination program (centers for disease control and • patient-centered primary institute care coordination tip sheet (patient-centered primary care • patient-centered primary institute referral and care coordination (patient-centered primary c • boston medical center office based addiction treatment continuum of care echo (boston • boston medical center nurse care manager office based addiction treatment (boston medic mental health and polysubstance use treatment integrated into moud care preventing addiction related suicide general principles for the use of pharmacological agents to treat individuals wi disorders tip : substance abuse treatment for persons with co-occurring disorders pharmacologic guidelines for treating individuals with post-traumatic stress dis (substance abuse and mental health services administration association learning center: treating co-occurring depression and op • integrated group therapy bipolar and substance use disorders unified protocol for the transdiagnostic treatment of emotional disorders with community reinforceme motivational incentives (center for the application of substance abuse technologies • addiction technology transfer center network motivational interviewing training (addictio • providers clinical support system webinars (providers clinical support system brief: substance use and suicide: a nexus requiring a public health approach services administration tip : addressing suicidal thoughts and behaviors in substance abuse treatmen services administration and center for substance abuse treatment • national institute of mental health suicide prevention website (national institute of mental h • suicide prevention resource center programs and resources (substance abuse and mental health servic • ryan white hiv/aids medical case management the massachuse • ohio recovery housing (ohio recovery housing, ) • kentucky: voices of hope chrysalis house (residential sud treatment and supportive housing) (chrysalis hou • kentucky: acquired immunodeficiency syndrome volunteers ky (supportive housing, recove moud =medication for opioid use disorder samhsa=substance abuse and mental health services administration; echo =extension for community healthcare outcomes; hrsa= the health resources and services administration key: cord- - hhx mdk authors: mcgrail, matthew r.; o’sullivan, belinda g.; russell, deborah j.; rahman, muntasirur title: exploring preference for, and uptake of, rural medical internships, a key issue for supporting rural training pathways date: - - journal: bmc health serv res doi: . /s - - - sha: doc_id: cord_uid: hhx mdk background: improved medical care access for rural populations continues to be a major concern. there remains little published evidence about postgraduate rural pathways of junior doctors, which may have strong implications for a long-term skilled rural workforce. this exploratory study describes and compares preferences for, and uptake of, rural internships by new domestic and international graduates of victorian medical schools during a period of rural internship position expansion. methods: we used administrative data of all new victorian medical graduates’ location preference and accepted location of internship positions for – . associations between preferred internship location and accepted internship position were explored including by rurality and year. moreover, data were stratified between ‘domestic graduates’ (australian and new zealand citizens or permanent residents) and ‘international graduates’ (temporary residents who graduated from an australian university). results: across – , there were applicants who filled internship positions ( % oversubscribed). domestic graduates filled most ( . %, / ) rural internship positions, but significantly less than metropolitan positions ( . %, p < . ). only . % ( / ) included a rural location in their top five preferences, less than for international graduates ( . %, p < . ). a greater proportion of rural compared with metropolitan interns accepted a position not in their top five preferences ( . % versus . %, p < . ). the proportion nominating a rural location in their preference list increased across – . conclusions: the preferences for, and uptake of, rural internship positions by domestic graduates is sub-optimal for growing a rural workforce from local graduates. current actions that have increased the number of rural positions are unlikely to be sufficient as a stand-alone intervention, thus regional areas must rely on international graduates. strategies are needed to increase the attractiveness of rural internships for domestic students so that more graduates from rural undergraduate medical training are retained rurally. further research could explore whether the uptake of rural internships is facilitated by aligning these positions with protected opportunities to continue vocational training in regionally-based or metropolitan fellowships. increased understanding is needed of the factors impacting work location decisions of junior doctors, particularly those with some rural career intent. improved healthcare access for rural populations through a more equitable distribution of the medical workforce remains a major concern internationally [ , ] . moreover, addressing health workforce maldistribution is critical to improving health outcome discrepancies in many rural populations [ , ] . this problem has had extensive policy development at the global scale, however, there is a demand for stronger evidence to inform regional policy makers of effective and well-targeted policies [ , ] . world health organization (who) guidelines recommended a focus on rural education, regulation, financial and professional support, for promoting better healthcare access through improved health workforce supply and retention [ ] . these are supported by evidence of the benefit of rural training interventions and policies for improving rural workforce supply and retention [ ] [ ] [ ] . this evidence reinforces the positive impact of rural medical school training (the longer the better) and selecting students more likely to practice rurally because of their rural childhood origin or interest in rural work [ ] [ ] [ ] [ ] [ ] [ ] . rural training pathways are critical interventions for producing a skilled, well-distributed and stable rural workforce given that offering financial incentives to shift the established medical workforce into relatively underserved areas have limited effect [ ] , and are costly [ ] . but there remains little published evidence about postgraduate rural pathways which potentially have strong implications for a long-term skilled rural workforce [ ] [ ] [ ] . furthermore, there is only limited information about the uptake of prevocational rural pathways and related internships, in health systems dissimilar to north america's direct entry pathways to residency training. this paper aims to address this gap by examining uptake and preference of rurally-located internships in one state in australia. australia uses a broad range of who-recommended strategies for rural education, regulation, financial and professional support policies in different forms and with different effects [ ] . regulatory workforce policies, such as those requiring rural return of service in exchange for monetary compensation or awarding visas for overseas trained doctors (otds) who work in rural areas, tend to improve rural recruitment but with trade-offs of lower rural retention, especially once the return of service period has been fulfilled, with lower levels of satisfaction having been reported [ ] [ ] [ ] . australia's key regulatory policy since has required overseas trained doctors and international students graduating from australian medical schools to work in districts of workforce shortages (dws) (mainly in rural areas) for up to years after they enter the medical workforce, in order to gain a provider number for access to medicare billing. this policy's 'success' is strongly associated with australia's current high reliance on otds to supply its rural medical workforce [ , ] . as such, growing the number of domestic graduates who enter and remain in australia's rural workforce remains a key priority. the australian government has invested in rural medical education policies since the s, with the aim of increasing production of domestic students who choose to work rurally. a key strategy has included funding national rural clinical schools, expanding both existing medical programs and introducing new medical programs at australian universities that are offered in their entirety within rural areas [ ] . these must provide a minimum of % of medical students with at least months rural training opportunities and universities must select at least % rural background students into their medical schools. this training targets domestic, not international students in most cases [ ] . many doctors have now emerged from this expanded rural training initiative [ ] , and now increasing attention is being given to post-graduate pathways to retain them in rural areas [ ] . to date, rural vocational (specialty) training opportunities have been mainly restricted to general practice (gp). from , the integrated rural training pipeline (irtp) strategy aimed to expand other post-graduate training pathways, particularly for graduating students who have trained in rural clinical schools including by creating more rural prevocational and rural registrar training options to attract and keep graduates on a rural training pathway to various specialist career options [ ] . additionally, the irtp-specialist training program funds new non-gp specialty rural places, where the trainee must spend at least two-thirds of their training in a rural area. the first national rural health commissioner was appointed in by the commonwealth government to develop and broker national rural generalist training pathways [ ] . new regional training hub managers were also appointed in regions in to foster medical graduate's connections to rural pathways [ ] . however, supplying new rural vocational positions largely depends on graduate doctors electing to stay in rural prevocational pathways, including during the internship period. in australia, each doctor's training pathway is administered by multiple providers including universities (basic qualifications), jurisdictional health services which offer prevocational positions for junior doctors (including newly graduated doctors in their first postgraduate year, hereafter termed 'interns') and specialty colleges [ ] . internship training is required for general registration with health services considering interns as the backbone of basic service provision in hospitals [ ] . it is a period when new doctors develop broad and generalist skills, get wide exposures to different medical conditions but also begin to confirm career decisions [ ] . rural internships are important for producing a sufficiently distributed and appropriately skilled rural medical workforce [ ] [ ] [ ] . in the last decade many australian states have expanded the number of available rural internship positions. in parallel, there has also been a rapid growth in the numbers of graduating medical students in australia around graduates in expanding to in [ , ] . this has not been fully matched with growth in internship training places, thus creating angst about securing an intern position which has been evident as national competition for internships increases [ , ] . some states, such as victoria, have used the expansion as an opportunity to grow the proportion of internship positions in rural locations, with a view to improving the geographical maldistribution of its medical workforce. as per table , internship position growth in victoria across - has seen rural internship positions tripling in number (+ %, from to ), compared to metropolitan areas (+ %, from to ). australia's most populated state, new south wales (nsw), by comparison, saw only modest growth in rural intern positions in a similar period (approximately + % in - ) [ ] . victoria's overall proportion of rurally located internships rose in - from to %, now closely mirroring the state's rural population [ ] . the hope is that this growth is matched with interest and that australian government investment in rural training for domestic students means that there are sufficient numbers of prospective interns who are both interested in rural work and choose to apply to fill these positions. the objective of this exploratory study, therefore, is to describe and evaluate preferences for, and uptake of, rural internships in victoria by new victorian-trained medical graduates (hereafter called domestic) and victorian-trained international medical graduates (international) during a period of rural internship position expansion, to inform optimising of rural training pathway policies. under a formal national agreement of all jurisdictions through the council of australian governments (coag), commonwealth supported (subsidised fees) domestic medical graduates are guaranteed to receive an internship position in the same state or territory as they trained. additionally, victoria (and some other jurisdictions) extend this guarantee to domestic full fee-paying students (those with australian or new zealand citizenship or permanent residency). competition for remaining internship places is from graduates of australian medical schools who were international students (full fee-paying students, with temporary residency visas), domestic graduates from schools in other australian states and territories, and graduates from international medical schools. none of these latter three groups of graduates is guaranteed intern positions in victoria or any other jurisdiction. in victoria, internships are allocated via a statewide centralised process that occurs on a strict timeline [ , ] . the postgraduate medical council of victoria (pmcv) administers a matching service on behalf of the victorian department of health and human services. eligibility criteria for participation in victorian internship matching is detailed in table and criteria have not changed since they were introduced in / . eligible candidates nominate two professional referees, upload their curriculum vitae, and provide a priority list (ordered preference ranking) of up to health services/ internship training programs from a choice of metropolitan internship sites and rural sites as of [ ] . health services may also request additional information such as a covering letter and may interview candidates in order to produce their lists of preferred candidates. the matching process occurs over three rounds using a computer-based algorithm, which considers each candidate's preference ranking for internship in different sites and the preferences that health services have for different candidates. no offers of victorian internship positions are made outside of the statewide pmcv matching process, though if applicants are not computer matched then subsequent direct discussions with a health service may lead to an offer and acceptance. the first round comprises victorian-trained australian or new zealand citizen or permanent resident ('domestic') graduates (priority group ). the second round comprises victorian-trained temporary resident graduates ('international') (priority group ). subsequent offers are made by health services directly to candidates not already matched in either priority group or , including other groups such as graduates from other australian jurisdictions or from overseas campus of an accredited australian or new zealand medical school. we used administrative data about all pmcv applicants' location preferences and accepted locations of victorian internship positions for - . these data were deidentified by pmcv and provided to the research team. data comprised the preferences of each candidate (ranking from up to ); the internship offer made to each candidate (either through computerised matching process or directly by a health service following the computerized matching process); the position matched from each candidate's preference list; and the uptake of each internship position. outcomes of interest included preference and uptake of internship positions - , with internship location geocoded using the australian standard modified monash model (mmm) rurality scale as mmm- 'metropolitan'; or mmm- - 'rural'. additionally, rural locations were stratified as mmm- 'large regional' (≥ , population) and mmm- - 'smaller regional or rural towns' (< , population). data were also available about a specific type of internship called the rural community-based internship training (rcit) program (now called the victorian rural generalist program). this was introduced in victoria in , and involved internships based in small rural general practices and hospitals with rotations to larger regional hospitals and community settings. the rcits are explicitly aimed at improving internship distribution and the number of rcit positions increased to descriptive statistics explored the characteristics of candidates relative to their preference list, eligibility group and location of preferred health services/rcit positions. data were disaggregated by application year ( - ), priority group (eligibility criteria related to being in first or subsequent rounds of matching process), rurality of internship location preference and position taken, age and gender, before being aggregated for overall statistical testing. pearson chi-squared tests were used to compare proportions and t-tests to compare means. all calculations were performed using statase . (statacorp, college station, tx, usa) and the significance level was α = . . preferences table reveals that domestic graduates nominated fewer preferences (mean . ) compared with international graduates (mean . , p < . ) and other graduates (mean . , p < . ). they also had significantly fewer preferences for rural locations (mean . ) compared with international graduates (mean . , p < . ) and other graduates (mean . , p < . ). of those accepting positions, . % ( / ) of domestic graduates did not have any rural locations in their preference list. only . % ( / ) had at least one rural location in their top five preferences, which was a significantly lower proportion than for international graduates ( . %, p < . ) and other graduates ( . %, p < . ). (table ) . a greater proportion of rural interns than metropolitan interns matched a preference not in their top five choices ( . % vs. . %, p < . ) and were aged + years ( . % vs. . %, p < . ) ( table ) . a smaller proportion of rural than metropolitan interns were domestic graduates ( . % vs. . %, p < . ). there was no difference in the proportion of female interns in metropolitan and rural locations. overall, in - , only internship positions offered through the matching process were declined, mostly ( %) by domestic graduates. most declined offers were in metropolitan locations ( , . %), though proportionally rural positions were . times more likely to be declined compared with metropolitan positions. among the declined rural offers, ( . %) had matched their st preference, ( . %) nd - th preference and ( . %) th or lower preference positions. most declined metropolitan internship offers ( . %) were amongst a candidate's top five preferences, significantly higher than for declined rural offers ( . %, p < . ). table shows the preferences and uptake of internships over each of years. between and , there was a significant increase in the average number of preferences listed per candidate (from . to . , p < . ), for rural positions (from . to . , p < . ) and matching rcit positions nominated as a top five preference (from . to . %, p = . ). the proportion of interns not including any rural location in their preference list also decreased significantly overall (from . to . %, p < . ). our study is the first to explore patterns of internship preferences and uptake in australia across an entire jurisdiction over time. our results suggest that domestic graduates are under-represented in rural positions, filling % of those positions compared with % of metropolitan positions. also, over half of the rural positions are filled by applicants who either did not prioritise a rural internship position in their top five preferences or were matched outside of the computer algorithm. these findings suggest that a majority of domestic graduates may not be attracted to rural internships, and those doing rural internships tended to not have selected their internship location as a high preference. as such, it appears that rural internships may not be attractive to sufficient numbers of this cohort, and that expanding the numbers of rural internship positions alone may not effectively enhance domestic rural workforce supply. policy is needed which addresses how to attract greater numbers of domestic students to opt for rural internships, especially those emerging from undergraduate training in rural clinical schools, as this cohort is likely to have the most experience of and interest in rural medicine. evidence of specific reasons why rural internships are less attractive is weak. a recent study of interns in another australian state (new south wales) using qualitative methods and focus group discussions suggested that rural internships provided high quality training and supervisory support and increased clinical work opportunities, mostly undertaken as part of a smaller team [ ] . however, many feared this may limit their exposure to higher acuity presentations, restrict research opportunities and remove networking opportunities, potentially disadvantaging future applications to specialty training. additionally, high levels of competition for vocational training positions from increased graduate numbers may perpetuate the belief of many rural interested candidates that establishing professional connections with clinical directors of large metropolitan units is critical in order to gain entry into specialty training [ , ] . a recent opinion piece from australia's rural medical students reiterates fears of reduced access to training programs and missing out on key professional relationships and supports via rural internships [ ] . a national study reinforced this, showing metropolitan junior doctors were more satisfied with the network of doctors supporting them than rural junior doctors although the latter had higher overall satisfaction and were significantly more satisfied with work-life balance, ability to obtain leave, study time and access to leisure interests than metropolitan counterparts [ ] . given this context, it is likely that many junior doctors even those with a strong interest in rural practicefeel pressured to choose to train in metropolitan locations. as such, increased uptake of rural internships may be facilitated by aligning these positions with protected opportunities to access vocational training in regionallybased or metropolitan fellowships, with a key option being weighted selection criteria to specialist colleges for doing internships in regional locations. many qualities of rural intern positions have good potential to attract domestic students, should common concerns related to professional networks and accessing sought after vocational training pathways be adequately addressed [ ] . future research could examine the nature of professional networks needed by rural junior doctors for career progression in different specialties and what interventions might be most effective. addressing such research gaps may assist rural policy makers and health services to devise better strategies to attract students hoping to become rural specialists, giving them more confidence or certainty that a rural internship will connect with ongoing rural specialty training opportunities [ ] . this is particularly important as this very early stage of medical graduates' careers (i.e. internship year) is a key time for 'settling down' in a location and therefore comprises an additional opportunity to increase rural immersion and table interns' matched preferences and characteristics relative to internship location table a any rural (mmm - ) = large regional + smaller regional / rural town + rcit (smaller rural) positive role models. this may reduce the risk of "urban narcissism" towards rural doctors [ ] , increase their interest in generalist careers that fit with most rural locations [ ] , and strengthen their connections to specific regions where they have previously trained and lived [ ] . currently, specialty college entry criteria tend to prioritise the achievement of focused skills, rather than broader experience that is typical of medical practice in rural areas, despite diluted learning acknowledged in crowded metropolitan tertiary hospital training environments [ ] . this focus is increasingly seeing medical graduates pursue specific technical skills including pursuing research publications, which may be more challenging to achieve in rural locations [ ] . a recent snapshot survey of the broad intentions of the next generation of rural doctors (current undergraduates attending a rural conference) suggested they had rural generalist career intentions but were wedded to doing part of their postgraduate training in metropolitan areas [ ] . linking this group with rural internship positions (and beyond) as part of a continuous and secure regional postgraduate training programs with a line of sight to specialist college selection, may be important to increase the attractiveness of rural internships for this group, but this needs to be clarified with further research. our findings may also have important implications for policies concerning how to prepare international graduates of australian medical schools. currently (notwithstanding the effect of covid- ), universities are heavily reliant on income generated from these students, which subsidise training of domestic graduates. come the intern year, however, the tensions between producing a self-sufficient, well-distributed domestic medical workforce (including retaining graduates from rural undergraduate clinical training) and providing international graduates with requisite internships in order to gain general medical registration becomes apparent. approximately % of this group stays in australia and secure an internship, but universities are keen to maximise internship opportunities for international graduates so that the medical degrees that they offer remain attractive. intern placement prioritisation for international graduates differs between jurisdictions. in victoria, they are prioritised higher than all medical graduates from other jurisdictions, such as those who may have grown up in rural victoria but travelled to a different state for their medical training. the latter example are perhaps more likely to work long-term in rural victoria if given the opportunity to return to victoria and take up a rural internship. international graduates in comparison are less likely to have any connection to rural areas they are applying to undertake an internship in, as the government-funded rural training opportunities during medical school (rural clinical school training immersion) is largely reserved for domestic students [ , ] . they are also unlikely to have spent childhood periods in rural victoria. this lack of connection to place is expected to reduce recruitment to rural practice and longer term retention [ ] . opportunities remain, therefore, for selection processes to consider implications for medical workforce distribution ahead of implications for victoria's international market for medical education. in nsw, for example, domestic medical students graduating from other jurisdictions are prioritised ahead of international students. our study has some limitations largely related to its use of administrative data. for example, it was unable to link preference and uptake outcomes with two key factors associated with rural practice, namely, having a rural background and prior rural training during basic medical training. other potentially important data items not available were career intent, particularly for generalist versus specialist choice, as well as whether individuals were required to serve any rural bonded periods. this may be relevant to explore whether including the doctor's interests to match against longer-term regional workforce planning imperatives as part of selecting for rural internships improves uptake. this may achieve a better match of candidates for the region, over the current computer-generated match that is relatively impersonal. career decision making of junior doctors is known to be complex and multifactorial, with considerations including place preferences, partner needs and training demands overlaid on the doctor's work expectations related to their career and broader life [ ] [ ] [ ] . despite the limitations of using administrative data, these allowed us to capture the whole victorian cohort over time, thereby avoiding issues of non-response bias. a further limitation is that the study setting is a single australian jurisdiction, and internship policies differ by jurisdiction. our study was additionally not able to link the internship location with longer-term work location outcomes, particularly relating to career specialty, although this is planned as part of further work. finally, this study did not capture the reasons or motivations behind each candidate's preferencing and uptake decisions nor what strategies may be effective to increase both preferencing and uptake of rural internships by domestic graduates, particularly those emerging from rural undergraduate training. these elements could be explored in further research. the finding that most rural positions tend to be filled by applicants either matched outside of their top five preferences or by unmatched candidates and international graduates indicates that the expanded number of rural internships in victoria are not sufficiently attractive to applicants, particularly to domestic graduates. the findings suggest that it may be important to focus on strategies to promote greater uptake of rural internships by domestic graduates (particularly retaining graduates from rural undergraduate medical training). this may rely on rural clinical schools and regional training hubs working with regional health services, students, clinicians and specialty colleges to address the attractiveness of rural internships to domestic graduates. further research could explore whether the uptake of rural internships is facilitated by aligning these positions with protected opportunities to continue vocational training in regionally-based or metropolitan fellowships. moreover, increased understanding is required of the factors impacting work location decisions of junior doctors, particularly those with some rural career intent. evaluated strategies to increase attraction and retention of health workers in remote and rural areas not enough there, too many here: understanding geographical imbalances in the distribution of the health workforce a universal truth: no health without a workforce. forum report, third global forum on human resources for health. recife, brazil: geneva, global health workforce alliance and world health organization primary care and equity in health: the importance to effectiveness and equity of responsiveness to peoples' needs where to next for rural general practice policy and research in australia? understanding shortages of sufficient health care in rural areas world health organization. increasing access to health workers in remote and rural locations through improved retention: global policy recommendations interventions for increasing the proportion of health professionals practising in rural and other underserved areas factors influencing recruitment and retention of healthcare workers in rural and remote areas in developed and developing countries: an overview a scoping review of the association between rural medical education and rural practice location duration and setting of rural immersion during the medical degree relates to rural work outcomes the rural pipeline to longer-term rural practice: general practitioners and specialists australia's rural medical workforce: supply from its medical schools against career stage, gender and rural-origin the relationship between entering medical students' backgrounds and career plans and their rural practice outcomes three decades later association between self-efficacy, career interest and rural career intent in australian medical students with rural clinical school experience do rural incentives payments affect entries and exits of general practitioners? getting doctors into the bush: general practitioners' preferences for rural location vocational training of general practitioners in rural locations is critical for the australian rural medical workforce characteristics of queensland physicians and the influence of rural exposure on practice location the impact of rural rotations on urban based postgraduate learners: a literature review the effect of the physician j- visa waiver on rural wisconsin the comparative retention of national health service corps and other rural physicians. results of a -year followup study international medical graduates mandated to practise in rural australia are highly unsatisfied: results from a national survey of doctors reviewing reliance on overseas-trained doctors in rural australia and planning for self-sufficiency: applying years' mabel evidence rural work and specialty choices of international students graduating from australian medical schools: implications for policy australian government department of health. rural health multidisciplinary training program canberra: dept of health effective dimensions of rural undergraduate training and the value of training policies for encouraging rural work two decades of building capacity in rural health education, training and research in australia: university departments of rural health and rural clinical schools integrated rural training pipeline for medicine (irtp) canberra: dept of health australian government department of health. rural health commissioner canberra: dept of health regional training hubs canberra: dept of health will australia have a fit-for-purpose medical workforce in ? review of medical intern training: final report. canberra: australian health ministers' advisory council does recruitment lead to retention? rural clinical school training experiences and subsequent intern choices council of australian governments health council internship at the ends of the earth -a way to recruit physicians? rural remote health making rural health care better: how to attract interns to rural hospital medical training review panel (mrtp) publications canberra medical students to miss out on internships as doctor shortage looms. syd morning herald the struggle of being an international medical student in australia postgraduate medical council of victoria. postgraduate medical council of victoria inc the medical schools outcomes database project: australian medical student characteristics the case for a national intern allocation system in australia postgraduate medical council of victoria. candidate user guide intern computer match murray to the mountains intern training program: involvement of small health services medical students on long-term rural clinical placements and their perceptions of urban and rural internships: a qualitative study outcomes of australian rural clinical schools: a decade of success building the rural medical workforce through the education and training continuum myths and misinformation about rural internships attracting junior doctors to rural centres: a national study of work-life conditions and satisfaction rural physicians: training and professional support study a new model to understand the career choice and practice location decisions of medical graduates geographical narcissism in psychotherapy: countermapping urban assumptions about power, space, and time preparation for general practice vocational training: time for a rethink rural training pathways: the return rate of doctors to work in the same region as their basic medical training importance of publishing research varies by doctors' career stage, specialty and location of work preferences and pathways of the next generation of rural doctors factors influencing the choice of specialty of australian medical graduates understanding the factors influencing junior doctors' career decisionmaking to address rural workforce issues: testing a conceptual framework how do workplaces, working practices and colleagues affect uk doctors' career decisions? a qualitative study of junior doctors' career decision making in the uk publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we acknowledge the partnership with the postgraduate medical council of victoria (pmcv) inc., which supported this study through provision of data, as well as the policy support from department of health and human services, victoria. authors' contributions mm, bo, dr contributed to conceiving and designing the study. mr led data acquisition, original analyses and writing of the original draft, under the guidance of mm, bo, dr. mm validated all results (following mr's passing) and led reviewing and editing of the final manuscript. bo and dr (exception: mr) drafted, read and approved the final manuscript. this study was not supported by external grant funding. the datasets produced and/or analysed during the current study are available from the corresponding author on reasonable request. not applicable. the authors declare that they have no competing interests. key: cord- -m rne l authors: cheema, s.; ameduri, m.; abraham, a.; doraiswamy, s.; mamtani, r. title: the covid- pandemic: the public health reality date: - - journal: epidemiol infect doi: . /s sha: doc_id: cord_uid: m rne l the coronavirus disease (covid- ), while mild in most cases, has nevertheless caused significant mortality. the measures adopted in most countries to contain it have led to colossal social and economic disruptions, which will impact the medium- and long-term health outcomes for many communities. in this paper, we deliberate on the reality and facts surrounding the disease. for comparison, we present data from past pandemics, some of which claimed more lives than covid- . mortality data on road traffic crashes and other non-communicable diseases, which cause more deaths each year than covid- has so far, is also provided. the indirect, serious health and social effects are briefly discussed. we also deliberate on how misinformation, confusion stemming from contrasting expert statements, and lack of international coordination may have influenced the public perception of the illness and increased fear and uncertainty. with pandemics and similar problems likely to re-occur, we call for evidence-based decisions, the restoration of responsible journalism and communication built on a solid scientific foundation. the number of confirmed infections with sars-cov- has reached million worldwide, and mortality from covid- is estimated to be above [ ] . all the evidence thus far available quite clearly shows that those at highest risk of a severe illness and death are the elderly, individuals with existing co-morbidities and the immunocompromised. undeniably, the covid- pandemic has resulted in loss of human life; it has wreaked havoc on healthcare systems worldwide, highlighting inequities in healthcare availability and access; it has resulted in drastic public health measures in most countries of the world. low-and middle-income nations with weak health systems, dwindling economies, high population density, a high reliance on informal employment, poor technological infrastructure and the double burden of non-communicable and communicable disease are, in particular, more vulnerable to the covid- challenge than high-income nations. as additional information about the infection and its effects becomes increasingly available, a number of questions which require an explanation arise. while these questions might have been premature a few months ago when very little was known about the epidemiology of the infection, in this commentary we argue that they are now very timely and that it is imperative these questions be addressed. the questions we specifically explore are: how serious is the covid- pandemic? how does it compare with the death burden from other causes? what have been the indirect health and social effects of the covid- pandemic? we also raise questions surrounding misinformation and its negative consequences on health. in exploring these questions and seeking possible answers, we first present data in two parts: (a) epidemiology of covid- and (b) comparison of covid- mortality with mortality from previous pandemics and other causes (for comparison, at the time of writing this paper, the total number of worldwide documented cases and deaths are and , respectively) [ ] . subsequently, we summarise the indirect repercussions of the covid- pandemic on non-communicable diseases, economy and lives of people. in the conclusion, we offer a few comments, share thoughts and raise some questions to help open a debate. based on a review of recent covid- literature, it is clear that the disease is minor in most cases [ , ] . the estimated infection fatality rate is in the range of . - . % [ , ] . the most recent systematic review and meta-analysis found a pooled infection fatality of covid- to be around % among studies with a low risk of bias (meyerowitz-katz and merone, , unpublished). the covid- case fatality rate, in principle an indicator of the virulence of the virus and severity of disease, has been a subject of debate. we now know that this rate may not accurately reflect the true infection fatality rate for a variety of reasons, examples of which include inadequate testing, the high number of mild/asymptomatic cases and failure to include those cases in computing the final rate and the country-specific methods of attributing deaths to covid- . a number of recent studies, primarily in the usa and in spain, which used antibody testing of population samples indicate that the number of undocumented infections is significantly high. these undocumented infections are often not included in computing the published case fatality rates. while the epidemiological implications of these results remain uncertain, they nevertheless strongly suggest that the infection fatality rate is much lower than the currently reported crude case fatality rate of . % [ ] . data are becoming available on the number of deaths per million population in the world health organization (who) weekly epidemiological reports. as of september , the who reported deaths per million in belgium, in the uk and deaths per million in the usa [ ] . this may be a truer reflection of the severity of covid- . we cannot and should not understate the severe disease paradigm in those at higher risk, which includes elderly individuals and those with underlying chronic conditions such as obesity, diabetes, heart disease, cancer, chronic lung conditions and an immunocompromised status. additionally, clinical presentation characterised by underlying pathological changes such as thromboembolism, cytokine release and inflammatory syndrome resulting in damage to the lungs, cardiovascular system, liver, kidneys, pancreas and nervous system, have been noted and described [ ] . here, we present data that pose questions on the magnitude of attention that the covid- pandemic has garnered compared to other public health issues that are in dire need of prevention and response. table compares the mortality of covid- with past pandemics of the th and st centuries. the mortality rate ratios (between past pandemics and covid- ) ranged from . times (for the lower estimate of the 'swine flu' pandemic) to over times (the upper estimate of the 'spanish' flu pandemic) that of covid- , after adjusting for population size. while coronavirus infection and death rates continue to escalate in some communities and decline in others, most experts agree that covid- continues to present a significant risk especially to the elderly and those with chronic conditions. it should be emphasised that the other causes of death during the covid- pandemic cannot be ignored. according to the institute for health metrics and evaluation (ihme), noncommunicable diseases account for over million deaths globally, while communicable and nutritional diseases claim over million lives [ ] . of the latter, . million deaths were from hiv/aids, tuberculosis, enteric infections, measles and other communicable diseases, most of which are preventable or effectively managed [ ] . in , there were million cases of malaria ( % confidence interval (ci): - million) worldwide, causing an estimated deaths [ ] . furthermore, we observe that deaths due to some acute and largely preventable causes far exceed covid- -related deaths. ihme data on mortality suggest that deaths due to injuries exceed those of covid- , as of september [ ] . road fatalities, including motor vehicles, cyclists and pedestrians, account for the largest proportion of these, at over . million. over % of injury-related fatalities and more than % of communicable and nutritional disease-related fatalities occur in low-income and low-middle-income countries. also, the who estimated that in , iatrogenic or medical errors caused . million deaths in the lower-and middle-income countries alone [ ] . these figures demonstrate that there are other concurrent problems causing distressingly high fatality rates that should not be overlooked as we continue to battle the covid- pandemic. while mortality is an important measure to ascertain the seriousness of covid- , its indirect serious health, social and financial consequences cannot be ignored. the presented data also suggest that the world today may be facing bigger public health challenges than covid- . is the world's reaction to the pandemic in terms of lockdown and travel restrictions disproportionate? we express our concern on the impact that these prevention measures have had, particularly on the mental health and livelihood of the poor and the most vulnerable populations. more importantly, the current scenario risks compromising the physical, mental and social health of individuals and communities [ ] . there are reports that persons with non-communicable diseases are failing to seek timely care due to fear of breaking lockdown rules, the threat of acquiring covid- during visits to healthcare facilities, and the choice made by hospitals to treat emergencies only [ ] . the risk of adverse health effects due to postponement of routine and elective care along with the severe mental stress and depression caused by this largely unprecedented situation is of grave concern. isolation, unemployment and loss of income may further compound the misery of already lonely individuals and families leading to a rise in self-harm and suicidal ideation, gender-based and domestic violence and the risk of substance use [ ] . the evidence of the dramatic economic impact of the measures undertaken in many countries to fight the spread of the disease is apparent. for example, in the usa, unemployment is at a record high and the economy is tumbling. nationwide, women, people of colour and the young are affected the most [ ] . the loss of income is likely to result in an increase of adverse health outcomes for many of the individuals affected, and the overall economic crisis will negatively impact the ability of entire countries to provide effective healthcare to their citizens. for individuals in low-and middle-income nations, loss of income, separation from loved ones and social isolation may be legitimately viewed as a bigger threat to long-term survival than the doom and gloom associated with the covid- pandemic. such a phenomenon has been observed during the economic crises faced by countries prior to the covid- pandemic. the financial crisis in greece, for instance, is estimated to have caused an additional deaths per month between september and december , due to cardiovascular disease, suicide and mental health illness disproportionately affecting women and people older than [ ] . job loss during a recession in the usa was associated with significant increases in mortality (hazard ratio: . ; % ci . - . ) [ ] . in brazil, a middle-income country, an analysis by hone et al. determined that a % rise in the unemployment rate was associated with . increase per each quarter in all-cause mortality and that unemployment resulted in additional deaths between and [ ] . hence, we believe that the mortality and disease burden during and after the covid- pandemic due to the social and economic consequences of the preventive measures and other factors can be substantially high. in addition to the direct effects on mortality, it is also feared that the economic disruptions could lead to the doubling of malnourished children in africa in the next - months [ ] . in a recent interview with the washington post, mark lowcock, united nations undersecretary general for humanitarian affairs, said, 'there's a huge covid- impact which is economic, and that is drowning out the disease itself' [ ] . it is hence critical to have an eye on the overall effects of the pandemic both on the short-and long-term. it is hard at this stage to reconstruct the sequence of events leading to the haphazard and incoherent response of most countries to the spread of the pandemic. however, we caution against fearmongering associated with sensational narratives and inappropriate media reporting, which can result in political pressures that global leaders, policymakers, employers and even some healthcare professionals may have been under, along with the initial uncertainties concerning the severity and nature of the disease. sensationalism, confusion stemming from contrasting statements from authority figures and the lack of international coordination have influenced the public perception of the illness, increasing fear and uncertainty. as an example, we cite the hydroxychloroquine saga. the sale of this medication in the usa jumped leaps and bounds with just a mention of its potential benefit from the us president [ ] . similarly, the differing recommendations on the use of masks from the who and the us centers for disease control have contributed to the public's confusion [ ] . in addition, the pervasive and increasing role that social media play in how people obtain and share information increases the risks of misinformation and confusion. misinformation can imperil the health of public in other ways. in a recent online us survey, it was observed that us adults are engaging in more frequent cleaning and disinfection of their home to prevent sars-cov- infection. the study points out that % use cleaning agents or disinfectants in an unsafe manner that presents health risks. for example, % reported using bleach on food (fruit or vegetables) and % reported using cleaning products on their skin [ ] . we should neither downplay nor overstate the pandemic risk. those at increased risk of severe disease should receive priority and be effectively managed. from a public health perspective, it is our opinion, that the lack of a timely internationally coordinated evidence-based approach, the inadequate preparedness of health systems and the absence of effective global leadership has driven us to the current health, economic and social disruptions. the lack of control and coordination over who is saying what, how, where and when, can propel misinformation, leading to fragmented decision-making and public confusion. should there not be an agreed upon deontological code to discourage sensational reporting? why are there not globally acceptable guidance statements on commonly used measures such as the use of face masks and chloroquine? the covid- pandemic continues to evolve. moving forward and with pandemics likely to re-occur, we call for health decisions to be made on the basis of science and public health evidence. restoration of responsible journalism and communication driven by scientific truth and valid data is of paramount importance. imparting public health education in school, college and community settings to inform learners about health, disease risks and general aspects of public health challenges such as infectious diseases is vital. worldometer database centers for disease control and prevention (cdc) database. available at imperial college london covid- response team estimates of the severity of coronavirus disease : a model-based analysis estimating the infection fatality rate among symptomatic covid- cases in the united states world health organization database world population history database reassessing the global mortality burden of the influenza pandemic the influenza pandemic: insights for the st century updating the accounts: global mortality of the - 'spanish' influenza pandemic world health organization (who) the h n influenza outbreak in its historical context novel swine-origin influenza a virus in humans: another pandemic knocking at the door world health organization (who) estimated global mortality associated with the first months of pandemic influenza a h n virus circulation: a modelling study institute for health metrics and evaluation (ihme) database world health organization (who) who-calls-for-urgent-action-to-reducepatient-harm-in-healthcare patients with chronic illness urgently need integrated physical and psychological care during the covid- outbreak covid- pandemic will have a longlasting impact on the quality of cirrhosis care the psychological impact of the covid- epidemic on college students in china unemployment soars to . %, job losses reach . million in april as coronavirus pandemic spreads total and causespecific mortality before and after the onset of the greek economic crisis: an interrupted time-series analysis recessions, job loss, and mortality among older us adults effect of economic recession and impact of health and social protection expenditures on adult mortality: a longitudinal analysis of brazilian municipalities world food program database the nutrition crisis of covid- will be even worse than the disease. the washington post association between us administration endorsement of hydroxychloroquine for covid- and outpatient prescribing covid- : what is the evidence for cloth masks? more than in us adults use disinfectants unsafely acknowledgements. we would like to thank ms. danielle jones (dj), lecturer, english as second language, pre-medical education weill cornell medicine-qatar for her english editing services. financial support. this research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors. ethical standards. not applicable. data availability statement. the dataset(s) supporting the conclusions of this article is (are) included within the paper. key: cord- - l y fw authors: lee, andrew; morling, jo title: covid - the need for public health in a time of emergency date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: l y fw nan on march , the world health organization (who) declared covid a pandemic. three months on from when china first alerted the world to the emergence of this threat, there were more than half a million confirmed cases and , deaths reported worldwide. large epidemics have sprung up in western europe and the united states. worryingly, the infection has also emerged in developing countries where the impact of the pandemic will probably be worst. infectious disease modellers at imperial college london estimate that without mitigation, covid could result in seven billion people infected and million deaths globally this year. consequently, the need for early and sustained suppression measures in these settings will be crucial in order to blunt the severity of the pandemic and save lives. in europe, italy was first to be most severely affected with numbers of cases exceeding china's tally, and a death toll already three times higher. in the worst affected areas, the outbreak was described as out of control and the response has been criticised for its "systematic failure to absorb and act upon existing information rapidly and effectively". key ingredients for an effective response appear to be the need for extensive testing, proactive contact tracing, an emphasis on home diagnosis and care, and the monitoring and protection of health care and other essential staff. it is clear that the speed of response needed to keep pace with the epidemic spread is exponentially faster than bureaucratic processes in health systems. crucially, there is a need for learning in order to identify and understand which approaches work. the italian epidemic was - weeks ahead of the rest of europe and certainly the uk. the uk adopted a graded contain-delay-mitigate-research response to the threat, moving from an initial containment phase characterised by rigorous contact tracing and testing, to a delay phase in mid-march. this approach was considerably less draconian than the lockdown measures introduced by the chinese government, possibly based on the concerns of wider socioeconomic and psychological impact of a full lockdown on society. it also did not align with the who approach and advice to "test, test, test" all suspected cases. what was not clearly articulated was the government's policy goal at the time, i.e. whether mitigation or suppression of the epidemic was the aim. what then emerged was an unverified narrative that the aim was to allow the infection to burn through the population in order to build up "herd immunity" which would have meant health services being overwhelmed and the deaths of many, predominantly elderly or with complex comorbidities, in the population. unsurprisingly, the uk government's approach was heavily criticised by academics who demanded the release of the evidence used to inform the government's approach. the release of the evidence has been slow and it is clear that the lack of transparency has affected trust in the government's response from academics and other allied professionals. transparency is crucial to retain the cooperation and trust of the scientific community, health workforce and the wider public. the uk government belatedly introduced lockdown measures and adopted a new strategy to suppress-shield-treat-palliate. however, this intervention may have come a little late in the course of the outbreak and cases of infection have taken off exponentially. compounded by supply issues for personal protective equipment for health staff and conflicting guidance on its use, this has further eroded trust in the government's approach. there was also a clear split in the public health community regarding the approach reflecting the uncertainties in what is known and not known about the virus and how best to tackle the pandemic. this has meant that the public health voice has been muddled and muted at a time when it needed to be crystal clear. another potential flaw to the uk's approach has been a strong focus on intensive care unit (icu) bed capacity as modelling predictions forecast demand for these beds far outstripping available supply. this has led to frenzied planning and efforts to boost icu capacity. unfortunately, this fails to build on learning from italy: like previous outbreaks of mers cov, healthcare settings are possible sites of infection, "as they are rapidly populated by infected patients, facilitating transmission to uninfected patients". the western health system paradigm is biased towards hospital modes of care delivery. however, in this epidemic scenario, what is becoming clear is that it is not just "an intensive care phenomenon, rather it is a public health and humanitarian crisis". in common with other humanitarian crises, the consequences are pervasive, wide and varied, and therefore require a response beyond a hospital or healthcare response. as a public health emergency, it is concerning that there is not a stronger public health lead and response. the societal impact needs to be considered. it is predictable that the poor, the marginalised, those on insecure employment, those living with disabilities, and other vulnerable groups, are at greatest risk not just from infection but the indirect consequences. after a decade of austerity in many european countries, where health and social care funding has been curtailed, coupled with disinvestments in public health systems, there are less resilient health systems to cope with this pandemic. government fiscal ideology of running healthcare like an airline, with for example bed occupancy rates of over %, has been flawed as it has taken out vital surge capacity much required in emergency situations. the economic agenda has been prioritised over public health and we are now seeing the fallout from this. health and social care funding is an investment and a national insurance policy against disasters such as the covid pandemic. there have been some emerging positives from this crisis. scientific advice, public health and the evidence-based approach to decision making is valued once more. there has been rapid and considerable information sharing by clinicians and academics enabled by social media, and in keeping with many other leading journals public health has made its covid content freely accessible. innovation in ways of working by frontline teams is emerging. in the uk, primary care and community health care integration, as well as vertical integration between hospital and out-of-hospital care, is taking place where once it may not have been contemplated. indeed, integration and coordination will be essential in order to augment existing health and care capacity to absorb the rise in health need. novel coronavirus( -ncov) situation report - (website) the global impact of covid- and strategies for mitigation and suppression. who collaborating centre for infectious disease modelling, mrc centre for global infectious disease analysis, abdul latif jameel institute for disease and emergency analytics lessons from italy's response to coronavirus evidence informing the uk's covid- public health response must be transparent. the lancet offline: covid- and the nhs-"a national scandal". the lancet impact of nonpharmaceutical interventions (npis) to reduce covid mortality and healthcare demand. who collaborating centre for infectious disease modelling, mrc centre for global infectious disease analysis, abdul latif jameel institute for disease and emergency analytics at the epicenter of the covid- pandemic and humanitarian crises in italy: changing perspectives on preparation and mitigation. nejm catalyst innovations in care delivery on a final note, this pandemic is a global health threat and this will require collaborative action to tackle. whilst the focus of the response may very much be local at the present time, only through concerted public health action worldwide can it be successfully suppressed, and hopefully in time eliminated. key: cord- -hwkmvo p authors: zhang, li; ma, min; li, danfeng; xin, ziqiang title: the psychological typhoon eye effect during the covid- outbreak in china: the role of coping efficacy and perceived threat date: - - journal: global health doi: . /s - - - sha: doc_id: cord_uid: hwkmvo p background: the influence of covid- on mental health problems has received considerable attention. however, only a few studies have examined the relationship between exposure to covid- and mental health problems, and no empirical study has tested the mechanisms between them. methods: we conducted a survey in provinces of china during – march to test the effect of the exposure level on mental health problems. our sample comprised participants who reported their perceived threat, coping efficacy, mental health problems and other demographic variables. multiple mediators path analysis was used in the data analysis. results: the results showed that the level of exposure to covid- in china was negatively associated with mental health problems, which confirmed the “psychological typhoon eye” effect. further analyses indicated that both perceived threat and coping efficacy partially mediated the relationship between them. however, coping efficacy explained the “psychological typhoon eye” effect. perceived threat mediated the positive relationship between exposure level and mental health problems. conclusion: this study detected the psychological typhoon eye effect and demonstrated the mediating role of coping efficacy and perceived threat between exposure to covid- and mental health problems. our findings suggest that policy makers and psychological workers should provide enough psychological services to low-risk areas as the high-risk areas. an important means of alleviating mental health problems is to improve coping efficacy. the recent outbreak of coronavirus disease in china and worldwide is a major public health emergency of international concern and has been characterized by the world health organization as one of the most challenging outbreaks to date. as of june , around . million confirmed cases globally, , in china, with , deaths ( . %) had been reported by the who. reviews in the field of exposure to covid- and mental health problems have called for research to test the relationship between them and to identify the mechanism underlying this relationship [ , , ] . the present study examined the risk perception factors that may explain how the level of exposure to covid- in china contributes to mental health problems. many organizations and researchers have highlighted concerns about mental health problems in affected communities. major public health emergencies, such as the severe acute respiratory syndrome coronavirus (sars-cov) in , the middle east respiratory syndrome coronavirus (mers-cov) in , the west africa ebola virus disease (evd) pandemic in - , and the global covid- pandemic typically lead to widespread fear and panic. for example, a critical review indicated that sars survivors consistently reported high rates of emotional distress persisting for years [ ] . during the west africa evd pandemic, there were increasing risks for new-onset psychological distress and psychiatric disorders [ ] . psychosocial effects include adjustment disorders, symptoms of ptsd, anxiety, and depression [ , , ] . to date, several studies have indicated the influence of covid- on mental health problems. for instance, the pandemic has burdened a major psychological stress on the medical workforce [ ] and could cause distress and leave many people vulnerable to mental health problems and suicidal behavior [ ] . thus, the influence of covid- on mental health problems cannot be ignored. to manage psychological sequelae, it is important to detect the antecedents of mental health problems. the antecedents of mental health problems during public health emergencies include many factors, such as the exposure level, quarantine, social support, social rejection or isolation, and the news media conveying risk-elevating messages about the public health crisis [ , , , ] . specific to covid- , some studies have revealed that risk perception, health anxiety, social media use and more media engagement are predicators to mental health problems [ , , ] . among these factors, an obvious objective variable is the extent to which people are exposed to emergencies and disasters in their daily life, i.e., the exposure level. according to the ripple effect found in the seminal study by slocvic ( ) , the impact of an unfortunate event decays gradually as ripples spread outward from the center; the closer people are to the center (i.e., the higher the exposure level), the stronger their mental distress is. however, a few studies have found that this is not the case [ , ] . studies have found that proximity to the center of the epidemic or devastated area was negatively related to anxiety levels [ ] , epidemic-related safety and health concerns [ ] . this phenomenon was termed the "psychological typhoon eye" effect to describe the public's psychological response, e.g., anxiety levels, safety and health concerns, to major emergencies and disasters. to date, the "psychological typhoon eye" effect has been detected after the wenchuan earthquake [ ] , during the sars epidemic [ ] and in relation to leadzinc mining risk [ ] . researchers have proposed three major possible explanations for this effect [ ] . the first explanation is psychological immunization theory, which assumes that resistance to a stressful event is naturally acquired through repeated exposure [ ] . people become desensitized by repeated exposure and can better prepare for stressful events. the second explanation is cognitive dissonance theory [ ] . cognitive dissonance is an uncomfortable psychological state in which the individual attempts to restore consistency or consonance by changing his or her beliefs and attitudes. when someone is at risk or in crisis, it is easier to change their beliefs and attitudes towards potential risk than to change their location [ , , ] . thus, people who are at the center of emergencies and disasters are presumably more likely than people living far away to believe that the risk is low and therefore continue to live nearby. the third explanation is the gap between experiencing/involving and imagining [ , ] , in which people in the center have a more accurate estimate of the risks based on real experience and involvement. to date, few empirical studies has tested these explanations. however, all the explanations suggest that the influence of the level of exposure to an unfortunate event on mental health problems may be mediated by subjective risk perceptions. risk perceptions are intuitive risk judgments [ ] that include "the process of collecting, selecting, and interpreting signals about uncertain impacts of events, activities, or technologies" ( [ ] , p. ). a meta-analysis by sheeran and his colleagues showed that risk perceptions have a close association with people's health behavior [ ] . according to protection motivation theory (pmt [ ] ;), health attitudes and behavior depend on two key psychological factors of risk perception, including one's perceived threat due to the risk and coping efficacy with regard to the ability to cope with the risk. perceived threat consists of estimates of the chance of contracting a disease (perceived vulnerability) and estimates of the seriousness of a disease (perceived severity). coping efficacy refers to beliefs about whether responses are available and effective in averting the threat (response efficacy) and whether people and groups can effectively respond to the risk and protect themselves from the hazard (self-efficacy). to a great extent, the three explanations for the "psychological typhoon eye" effect emphasize the role of coping efficacy in risk perceptions. the essence of psychological immunization is an increase in coping efficacy. with repeated exposure, individuals develop new patterns of coping to deal with the crisis. these patterns become an integral part of their repertoire of problemsolving responses and increase the likelihood that these individuals will deal more or less realistically with future hazards. in this way, the satisfactory resolution of one crisis increases resistance to subsequent adverse experiences [ ] . similarly, the essence of the gap between experiencing and imagining is that people in the center have high response efficacy and self-efficacy when they have a large amount of embodied experience or involvement compared with those without experience or involvement. additionally, cognitive dissonance theory emphasizes that after applying the cognitive strategies of rationalization (i.e., restoring consonance), the coping efficacy of people in the center is strengthened. among the three explanations, coping efficacy may be viewed as an internal mental indicator of psychological immunization. cognitive dissonance and experience act as two pathways to enhance people's coping efficacy. the former is a cognitive pathway and the latter is a behavioral pathway. the goal of this research was twofold. the first goal was to examine the robustness of the "psychological typhoon eye" effect during the covid- epidemic: the closer people are to the "center" of the epidemic (i.e., the higher the exposure level), the less serious their mental health problems are. to our knowledge, two studies have confirmed the "psychological typhoon eye" effect with regard to the level of exposure to epidemics and mental health problems. these studies examined the relationship between the level of exposure and anxiety levels [ ] and epidemic-related safety and health concerns [ ] . in this study, we assessed mental health problems using a questionnaire adapted from the psychological and behavioral questionnaire for sars [ ] . the questionnaire was designed to reflect the psychological state of the population during severe public health emergencies. it consists of five dimensions, i.e., depression, neurosism, phobia, compulsion-anxiety, and hypochondriasis. compared to the two studies stated above, this study investigated broader facets of mental health problems rather than one specific aspect. the second goal was to investigate the mechanism of the "psychological typhoon eye" effect. as stated before, even though some possible mechanisms have been proposed, none of them have been verified by empirical studies. we draw on protection motivation theory to formulate a theoretical model of how the exposure level during the covid- epidemic influences mental health problems. according to protection motivation theory, we hypothesized that the association between the exposure level during the covid- epidemic and mental health problems was mediated by both individuals' perceived threat of covid- risk and their coping efficacy (see fig. ). more importantly, we hypothesized that the valence of the mediating effects was distinct. both perceived threat and coping efficacy are positively correlated with the exposure level. however, perceived threat, which tends to aggravate mental health, is positively correlated with mental health problems. this hypothesis is based on evidence from sars studies and covid- studies. these studies showed that the relatively high perceived threat (severity and vulnerability) of sars/covid- played a pivotal role in the development of fear for the pandemic [ ] or psychological distress [ , , ] and increased the odds of individuals having a high level of depressive symptoms years later [ ] . in contrast, we hypothesized that coping efficacy, which tends to buffer mental health, is negatively correlated with mental health problems. this hypothesis is based on the fact that numerous studies have indicated fig. proposed model of exposure level, risk perception and mental health problems that self-efficacy is an effective factor to cope with a crisis and buffer psychological distress [ ] . a crosssectional study of respondents in a community health care setting showed that mental health status was negatively correlated with coping strategies, which can increase self-efficacy [ ] . a systematic review article [ ] found that psychological distress was prevalent among ebola survivors, whose coping strategies included engagement with religious faith, ebola survivor associations and involvement in ebola prevention and control interventions. all of these coping strategies are beneficial to enhance self-efficacy and response efficacy to relieve psychological distress. additionally, both qualitative and quantitative studies suggest that social support is an effective coping strategy for psychological distress [ ] because it can promote self-efficacy [ , ] . to achieve the two aforementioned purposes, we conducted a survey in provincial-level administrative divisions of china during - march . our first hypothesis is that a "psychological typhoon eye" effect exists between the level of exposure to epidemics and mental health problems. the second hypothesis is that there are two parallel routes between the exposure level and mental health problems. specifically, perceived threat mediates the positive relationship between the exposure level to epidemics and mental health problems, while coping efficacy mediates the negative relationship between them. in other words, coping efficacy could account for the "psychological typhoon eye" effect. the online survey platform wenjuanxing (https://www. wjx.cn) was employed to conduct this study during an eleven-day period ( - march ). the platform is a usable platform for user studies [ , , ] . in total, participants from provincial-level administrative divisions took part in the survey. the data of participants who did not complete the survey seriously (average answer time less than ms per question or answering repetitively for every question) were excluded. the final number of effective samples was . this study was approved by the school of sociology and psychology academic committee, central university of finance and economics. it takes around mins to complete all questionnaires in this study, and participants received five rmb after their participation. the mental health questionnaire was adapted from the psychological and behavioral questionnaire during sars [ ] , which was designed to reflect the psychological state of the population under severe public health emergencies. the adaptations made the items specifically applicable to covid- . twenty-five items were categorized into five dimensions: depression (α = . ; e.g., "i am easily fatigued and have difficulty recovering"), neurosism (α = . ; e.g., "i am interested in nothing"), phobia (α = . ; e.g., "i avoid going to hospitals or other crowded areas as much as possible and wear a mask when meeting people"), compulsion-anxiety (α = . ; e.g., "i have symptoms including rapid heartbeat, sweating and blushing"), and hypochondriasis (α = . ; e.g., "i worry about being infected when i have related symptoms"). all the items were measured on -point scales from to according to the level of emotion (none, mild, moderate and severe) or frequency of behavior (occasionally, sometimes, often, always). we averaged the scores to obtain a score for every dimension (possible score range: - ). we averaged the ratings to obtain the scores for each dimension and the overall mental health score (α = . ). the accumulative number of confirmed cases was regarded as an indicator to evaluate the severity of the covid- epidemic compared with other epidemic indicators (e.g., accumulative number of deaths, incidence rate, case fatality rate; see details in table ). all epidemic data were acquired from the official website of the national health commission on march nd, , and this website is the most authoritative website for information on the epidemic during the covid- in china. this study used the accumulative number of confirmed cases to represent the exposure level during covid- , see details in table . the perceived threat questionnaire was selfconstructed based on the model of risk perception by slovic [ ] . this questionnaire was designed to reflect perceived vulnerability and perceived severity during the outbreak of covid- . a total of six items were used to measure perceived threat initially. all the items were measured on a -point scale from (strongly disagree) to (strongly agree). item descriptions, and reliability and validity of variables can be seen in tables and . one item "i follow the official information released by the national health commission frequently" was removed due to its loading below . [ ] , so five items were used to represent perceived threat in final structural model. the discriminant validity results according to the fornell-larcker criterion are shown in table . the coping efficacy questionnaire was adapted from the perceived coping efficacy questionnaire used by kim, sherman and updegraff [ ] , which was designed to reflect the participants' belief that they and their groups could effectively protect themselves from the threat of ebola. the adaptations made the items specifically applicable to covid- . coping efficacy in the present study involves self-efficacy and response efficacy, and the four items are "i think the pneumonia epidemic will be effectively controlled", "i am optimistic about the situation of this epidemic", "i believe that i can effectively deal with the pneumonia epidemic" and "i believe we can effectively deal with the pneumonia epidemic". the first two items mainly reflect response efficacy, while the last two items mainly reflect the self-efficacy. four items were measured on a -point scale from (strongly disagree) to (strongly agree), and all of items have high reliability and validity, see details in tables and . the following covariates were included in the current study: data was analyzed using spss . , and structural models among exposure levels, perceived threat, coping efficacy and mental health problems were used by partial least squares structural equation modeling (pls-sem) in smartpls . (smart pls gmbh). pls-sem has often been recommended for data analysis in the case of nonnormal data [ ] . in this study, original number of cases in the provincial regions had great variances, and it doesn't conform to a normal distribution. for example, hubei province had , accumulated cases of covid- in march, while the accumulated cases in other provincial regions were under , see details in table . significance testing at the . level (two-tailed) in pls-sem were generated by using subsamples. the fig. was negatively related to mental health scores of people in provinces in china, r = − . , p < . . the correlations among the exposure level, risk perception and mental health problems during covid- are presented in table . the exposure level was negatively related to mental health problems, p< . . moreover, perceived threat was positively correlated with mental health problems, and coping efficacy was negatively related to mental health problems, ps < . . furthermore, the mediating effects of risk perception between exposure levels and mental health problems were tested using the pls-sem in smartpls. we generated bootstrapping subsamples from the original data set (n = ). table displays the direct and indirect effects after controlling for age, gender, income, educational level, and occupation (as covariates). the model explained . % variance in mental health problems. as shown in fig. , the exposure level exerted a significant indirect effect on public mental health via perceived threat and coping efficacy. the present study examined whether and how the level of exposure to covid- in china influenced mental health problems. the results showed that the exposure level to covid- in china was negatively associated with mental health problems related to covid- . specifically, the higher the exposure level to covid- , the better mental health was. more importantly, this study is the first to reveal the mechanism by which the level of exposure to covid- is linked to mental health problems related to covid- . specifically, perceived threat our finding of less serious mental health problems related to covid- for people with higher exposure levels to covid- in china confirms the psychological typhoon eye effect rather than the ripple effect. this finding is consistent with several previous studies [ , ] of public emergency events in china, which reported that proximity to the center of the epidemic or devastated area was negatively related to the public's irrational panic and mental distress. additionally, this finding is in accordance with a counterintuitive phenomenon in which intense states, such as emergency events, may abate more quickly than mild states because intense states trigger psychological processes that are designed to attenuate them [ ] . this phenomenon is an instance of a more general phenomenon known as the region-β paradox, which demonstrates that the relation between time and distance is nonmonotonic since people tend to use faster modes of transportation to cover longer distances [ ] . according to our findings, the underlying mechanism is that coping efficacy mediates the negative relationship between the level of exposure to covid- and mental health problems. in other words, it is the coping efficacy that accounts for the psychological typhoon eye effect. theoretically, as mentioned above, all explanations in previous studies, including the psychological immunization theory, cognitive dissonance theory, and the theory of the description-experience gap [ , ] , have emphasized the essential and potential role of efficacy. in the framework of psychological immunization theory, people in areas of high exposure would acquire more self-efficacy to cope with the epidemic because people become desensitized after repeated exposure. in this sense, their immunization ability is improved. similarly, in the framework of the description-experience gap theory, a more accurate estimate of the risks based on real experience and involvement increases the sense of control and efficacy. in the framework of cognitive dissonance theory, individuals apply the cognitive strategy of rationalization to achieve a state of consonance to restore a sense of self-control and selfefficacy. generally, people fail to anticipate the extent to which their psychological immune systems will hasten the recovery from disaster or major negative events, which is termed immune neglect [ , ] . as such, the triggered psychological process, i.e., the cognitive strategy of rationalization, helps individuals reduce negative states more quickly, which in turn subjectively enhances self-efficacy. in summary, all three explanations in previous studies directly or indirectly emphasize the role of efficacy, which is a pivotal factor in our model. the mediating role of coping efficacy can be easily understood in the context of collectivist chinese culture. in collectivist countries, when the public is exposed to the center of an epidemic or devastated area, a high level of coping efficacy is stimulated [ , , ] . appropriate response efficacy at the national level provides sufficient information and psychological support for the public, which in turn increases coping efficacy. additionally, many empirical studies have shown that self-efficacy is an effective factor to buffer psychological distress (e.g., [ , , ] ) and that response efficacy is positively correlated with health behavior (e.g., [ , ] ). this study also showed that the perceived threat of covid- was positively related to mental health problems related to covid- , which is consistent with previous evidence in relation to sars (e.g., [ , , ] ). furthermore, perceived threat mediated the positive relationship between the level of exposure to covid- and mental health problems related to covid- . specifically, this finding can explain the ripple effect (i.e., the higher the exposure level, the stronger the mental distress). however, considering the specific results of this study (i.e., the negative relationship between the exposure level and mental health problems), perceived threat may be a suppressor in the negative relationship. taken together, the two pathways suggest that the two mechanisms work simultaneously, but the valence of the indirect effects is reversed. in summary, coping efficacy rather than perceived threat could explain the psychological typhoon eye effect. regarding the psychological typhoon eye effect and the ripple effect, we preliminarily speculate which effect dominates may be a result of balance between perceived threat and coping efficacy. they can be seen as two sides of seesaw. when perceived threat is too high and coping efficacy is too low, people may experience the overwhelming fear and hopelessness [ ] . when coping efficacy is too high and perceived threat is too low, people may underestimate the risk and not adopt coping strategies to avert the threat. only when perceived threat is high enough to arouse coping efforts, and is nearly comparable to coping efficacy, both of them function greatly and they may dominate the seesaw alternatively. depending on which one is higher between coping efficacy and perceived threat, mental health problems related to the stressful emergency demonstrate the psychological typhoon eye effect or the ripple effect. when coping efficacy is higher than perceived threat, the related mental health problems may demonstrate the psychological typhoon eye effect; when coping efficacy is lower than perceived threat, the mental health may demonstrate the ripple effect. our data were collected on - march when the number of new cases decreased to single digits and scientific prevention and control as well as orderly resumption of work and production was promoted. perceived threat should be slightly lower than coping efficacy. therefore, the psychological typhoon eye effect was seen in our study. our assumptions can be used to understand some phenomena. for example, although cyberchondria is generally regarded to be negative, in the case of covid- , it might have made people understand the threat of the situation [ ] . however, when constantly seeing news and reports highlighting the threat of covid- , people will start to suffer from stress and anxiety [ ] . we can imagine that by seeking news and reports highlighting coping efficacy, people's mental health states may be better when their coping efficacy is increased to be higher than perceived threat. taken together, emergency management like covid- demands dynamic balance between perceived threat and coping efficacy [ , ] . however, our speculations are very preliminary and remains to be tested empirically in future studies. overall, this study confirmed the psychological typhoon eye effect during the outbreak of covid- in china and demonstrated the mediating role of coping efficacy and perceived threat between exposure to covid- and mental health problems. our findings suggest that policy makers and psychological workers should provide enough psychological services to low-risk areas as the high-risk areas. an important means of alleviating mental health problems is to improve coping efficacy. however, our findings may be restricted to people during an epidemic who live in collectivist countries. it remains unclear whether our findings are applicable in other countries or after the epidemic. china is a typical collectivist country. people in the center of outbreaks in china obtain intensive and extensive social support from the government, enterprises, individuals and society. therefore, coping efficacy can play an important mediating role. it is not clear whether our findings hold true in other countries. more studies in other countries are needed to confirm our findings. in addition, our results cannot exclude the possibility that people in the center of emergencies and disasters are occupied with coping, and therefore some types of mental health problems emerge only after the epidemic. some longitudinal studies have indicated that sars survivors still had elevated stress levels and worrying levels of psychological distress even after to years [ , ] . medical staff who performed mers-related tasks showed the highest risk of posttraumatic stress disorder symptoms even after time had elapsed [ ] . therefore, although we observed a negative correlation between the level of exposure and mental health problems, we do not suggest stopping or reducing psychological assistance to people in the center of the outbreak. psychological workers and policy makers should provide appropriate psychological services depending on the level of exposure and epidemic stage. finally, this study did not directly test the associations between coping efficacy and three explanations including psychological immunization, cognitive dissonance and description-experience gap. thus, these specific claims regarding their associations are more speculative, which would need to 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of medical staff treating patients with coronavirus disease (covid- ) in january and february in china the 'typhoon eye effect': determinants of distress during the sars epidemic proposals for coping with "psychological typhoon eye" effect detected in covid- the more involved in lead-zinc mining risk the less frightened: a psychological typhoon eye perspective publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations not applicable.authors' contributions lz and zx conceived and designed the study. dl performed the survey. mm and ld analyzed the data. lz and mm wrote the paper. the authors read and approved the final manuscript. the raw data supporting the conclusions of this manuscript will be made available by the authors to any qualified researcher. this study was approved by the administration committee of psychological research in central university of finance and economics and was in compliance with the ethical guidelines of the american psychological association. each participant signed the informed consent. not applicable. all of the authors do not have any interests that might be interpreted as influencing the research.received: june accepted: september key: cord- - rek authors: boucher, nathan a.; van houtven, courtney h.; dawson, walter d. title: older adults post-incarceration: restructuring long-term services and supports in the time of covid- date: - - journal: j am med dir assoc doi: . /j.jamda. . . sha: doc_id: cord_uid: rek objectives to describe long-term care services and supports (ltss) in the us, note their limitations in serving older adults post-incarceration, and offer potential solutions – with special consideration for the covid- pandemic. design narrative review setting and participants: long-term care services and supports for older adults post-incarceration methods literature review and policy analysis results skilled nursing facilities, nursing homes, assisted living, adult foster homes, and informal care from family and friends compose ltss for older adults, but their utilization suffers from access and payment complexities, especially for older adults post-incarceration. a combination of public-private partnerships, utilization of health professional trainees, and unique approaches to informal caregiver support, including direct compensation to caregivers, could help older adults reentering our communities following prison. conclusions and implications long-standing gaps in us ltss are revealed by the coronavirus (sars-cov- ) pandemic. older adults entering our communities from prison are particularly vulnerable and need unique solutions to aging care as they face stigma and access challenges not typically encountered by the general population. our review and discussion offer guidance to systems, practitioners, and policy makers on how to improve the care of older adults post-incarceration. the united states (us) imprisons a larger proportion of its population than any other country with , , prisoners in state prisons, , in local jails, and , in federal prison accelerates aging such that the prison population develops chronic illness - years earlier than community counterparts; incarcerated persons can be considered an 'older adult' by . , contributing factors -largely predating sentencing in these disenfranchised populations -are substance use, inadequate preventive care, mental illness, and the additional stress of being incarcerated. more than , individuals are released from state and federal prisons each year and over , of them will be age or above. these released older adults leave prison in worse health than when they arrived and in worse health than community- j o u r n a l p r e -p r o o f dwelling persons of the same age. despite the growing number of older incarcerated individuals and their potential impact on the health of society, little has been done to research optimal approaches to care once they are released. firm data on the full extent of health status disparity is scarce, but one texas study found that incarcerated persons years of age and older used an average of . prescription medications, which is higher than for non-incarcerated americans of the same age. inmates often have their necessary medications stopped once out of the care of the prison system including % of chronically ill state prisoners and over % of ill local jail inmates. regarding neurocognitive disease (such as dementia), the alzheimer's association indicates dementia prevalence in the general population will be increasing from . % in to . % in and then . % in . based on this, inmates with dementia may increase to approximately , in . furthermore, according to a recent systematic review, re-entry planning for older incarcerated persons is "sparse and the outlook is grim, given that many are released to urban communities characterized by health disparities and inadequate health care resources." and yet, there is strong evidence that optimal utilization of health-related services is linked to improved health outcomes, lower recidivism (re-incarceration), and improvements in housing, employability, and support provided through families. , recently released older adults, given high rates of health problems and chronic conditions, may simultaneously face both a great need for access to routine and acute health care, as well as an accelerated need for long-term services and supports (ltss) for their age. a lack of insurance and potential discrimination may compound their difficulty in obtaining continuity of care and medication upon release. the challenges they face are further exacerbated by the introduction of sars-cov- (or covid- ) into prisons and the community alike -with j o u r n a l p r e -p r o o f confined space and limited healthcare in the former, and little community support, stigma, and high-risk due to age in the latter. we explore these emergent challenges and offer early release is another approach to mitigate covid- transmission but is controversial due to real and perceived risks to communities such as recidivism or a perception of punishments the affordable care act, but again, processing these applications prior to release is critical for older adults between age - years of age to allow a seamless transition to the community. with the enhanced access that insurance coverage assures, the released persons should then be newly released individual will obtain ltss. while these individuals may also be medicare eligible due to age or disability status (so-called dual eligibles), medicare coverage of ltss is limited to just days of post-acute care (e.g., following a minimum three-day hospital stay). as such, medicaid is the default option for ongoing ltss. in many states, due to their medicaid better support of caregivers -who report financial, emotional and physical strain related to their caregiving role , --can lead to improved home care for older adults, an increasing concern for our aging population. better care at home for older adults can avoid unnecessary or there is an interrelation of correctional-system health, public health, and long-term care services and supports for older adults. yet, there is a major knowledge gap about older adults who are decarcerated due to a lack of data --including on rates of informal care and ltss utilization after release. we must first fill this knowledge gap to serve this population better. between these ltss components, and along the continuum from prison to community, there are mass incarceration: the whole pie medical problems of state and federal prisoners and jail inmates aging prison populations drive up costs kaiser family foundation since you asked: how many people aged or older are in prison incarceration nation medication prescribing practices for older prisoners in the texas prison system the health and health care of us prisoners: results of a nationwide survey alzheimer's association. alzheimer's disease facts and figures the looming challenge of dementia in corrections. correct care the health of america's aging prison population health and prisoner reentry: how physical, mental, and substance abuse conditions shape the process of reintegration health coverage and care for the adult criminal justice-involved population. menlo park: the henry j kaiser family foundation. . . us department of health and human services incarceration & social inequality disparities in the population at risk of severe illness from covid- by deliberate indifference: inadequate health care in u.s. prisons. ann intern med are our prisons and jails ready for covid- ? the guidelines on infection control in prisons need revising federal inmates to be confined to cells for two weeks amid coronavirus outbreak infection control in jails and prisons flattening the curve for incarcerated populations -covid- in jails and prisons flattening the curve for incarcerated populations-covid- in jails and prisons large scale releases and public safety virus-wracked federal prisons again expand release criteria us congress. covid- correctional facility emergency response act bureau of prisons. compassionate release criteria for elderly inmates with medical conditions the marshall project. too old to commit understanding violent-crime recidivism using jail to enroll low-income men in medicaid engaging individuals recently released from prison into primary care: a randomized trial a systematic review of randomized controlled trials of interventions to improve the health of persons during imprisonment and in the year after release medicaid expenditures for long-term services and supports (ltss) in fy . truven health analytics inc; . . medicaid.gov. home & community based services final regulation the place of assisted living in long-term care and related service systems. the gerontologist department of health and human services community-based care resident and community assistant secretary for planning and evaluation, department of health and human services disparities in assisted living: does it meet the hcbs test annual costs of care survey nowhere to go: homelessness among formerly incarcerated people. prison policy initiative securing private housing with a criminal record aging with serious mental illness: one state's response where does adult foster care fit in the long-term care continuum medical foster homes: can the adult foster care model substitute for nursing home care telehealth grew wildly popular amid covid- . now visits are plunging, forcing providers to recalibrate older adults' acceptance of a community-based telehealth wellness system. informatics for health and social care factors associated with receipt of training among caregivers of older adults informal and formal home care both increased between life interrupted: caregiving of justice-involved older adults center for health care strategies. restoring health and humanity to the recently incarcerated objective burden, resources, and other stressors among informal cancer caregivers: a hidden quality issue? better access, quality, and cost for clinically complex veterans with home-based primary care states leverage medicaid to provide nursing homes a lifeline through covid- north carolina department of health and human services medicaid temporarily increasing flexibility and reimbursement rates for primary and specialty america's health care safety net: intact but endangered the necessity of social medicine in medical education the ucsd student-run free clinic project: transdisciplinary health professional education predictors of caregiver and family functioning following traumatic brain injury: social support moderates caregiver distress factors associated with receipt of training among caregivers of older adults using care navigation to address caregiver burden in dementia: a qualitative case study analysis family caregiver use and value of support services in the va program of comprehensive assistance for family caregivers medicaid and chip payment and access commission federal medical assistance percentages and enhanced federal medical assistance percentages by state, fys covid- and the correctional environment: the american prison as a focal point for public health key: cord- -dbpt dhr authors: shook, natalie j.; sevi, barış; lee, jerin; oosterhoff, benjamin; fitzgerald, holly n. title: disease avoidance in the time of covid- : the behavioral immune system is associated with concern and preventative health behaviors date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: dbpt dhr the coronavirus disease (covid- ) poses a serious global health threat. without a vaccine, behavior change is the most effective means of reducing disease transmission. identifying psychological factors that may encourage engagement in preventative health behaviors is crucial. the behavioral immune system (bis) represents a set of psychological processes thought to promote health by encouraging disease avoidance behaviors. this study examined whether individual differences in bis reactivity (germ aversion, pathogen disgust sensitivity) were associated with concern about covid- and engagement in recommended preventative health behaviors (social distancing, handwashing, cleaning/disinfecting, avoiding touching face, wearing facemasks). from march to , , a us national sample (n = ) completed an online survey. germ aversion and pathogen disgust sensitivity were the two variables most consistently associated with covid- concern and preventative health behaviors, while accounting for demographic, health, and psychosocial covariates. findings have implications for the development of interventions intended to increase preventative health behaviors. in december , there was an outbreak of a novel coronavirus originating in wuhan, china. the virus and its resultant infection, coronavirus disease (covid- ) , spread rapidly across the globe, leading the world health organization (who) to label the outbreak a pandemic on march , [ ] . as of may , , there were over . million confirmed cases of covid- worldwide and over , deaths [ ] . in order to decrease transmission of the virus and reduce likelihood of illness, health organizations recommended a number of preventative health behaviors, such as washing hands frequently and thoroughly, avoiding touching one's face, disinfecting and cleaning frequently touched surfaces, engaging in social distancing (i.e., avoiding close contact with others), and wearing facemasks [ , ] . on march , , the us declared covid- a national emergency [ ] , which prompted many-but and would more frequently engage in social distancing, avoidance of face touching, handwashing, cleaning or disinfecting commonly used surfaces, and wearing a facemask. of note, at the time of data collection, health organizations did not recommend wearing facemasks by the general public, except if an individual had covid- [ ] . to isolate these associations, we accounted for a wide variety of demographic, health, social, and personality characteristics. data were collected on march and , , from a nationally representative sample of individuals residing in the us, recruited through the panel provider qualtrics for a larger longitudinal study about the effects of covid- . sample size was determined based on monte carlo simulations (n = , ) of the most conservative models for the data analysis plan associated with the larger longitudinal project. a minimum sample of was estimated to provide sufficient power (> %) to detect anticipated effects (β = . to . ) based on previous bis research assuming α = . . to account for missing or unusable data, we aimed to recruit a panel of at least us individuals. the current study used the first wave of data from the longitudinal study. four participants were excluded from analyses due to problematic response patterns (e. table for a full description of the sample). this project was approved by the university of connecticut irb (protocol #l - ). participants provided electronic consent before completing the study. after electronically agreeing to be part of the study, participants completed the primary study measures and other questionnaires in a random order, except for perceived health, illness recency, health history, and demographics which appeared last (see s appendix for all measures). upon completion, participants were given monetary compensation in an amount established by the panel provider. the online survey took approximately minutes to complete. bis indicators. the -item perceived vulnerability to disease questionnaire [ ] is an individual difference measure that consists of two subscales: germ aversion and perceived infectability. the germ aversion subscale includes eight items and measures individual discomfort with situations that imply high likelihood of pathogen transmission (e.g., "it really bothers me when people sneeze without covering their mouths"; α = . ). germ aversion is a component of the bis. the perceived infectability subscale includes seven items and measures perceived personal susceptibility to infectious disease (e.g., "i am more likely than the people around me to catch an infectious disease"; α = . ). although involving some level of subjective assessment, the perceived infectability subscale does not necessarily assess psychological disease avoidance processes; rather, responses to the items are in large part based on health history and biological susceptibility to infection [ , ] . as previous likelihood of contracting infectious disease may influence covid- concern and preventative health behaviors, we included perceived infectability as a covariate in the primary analyses. all ratings of items were made on a scale ranging from ("strongly disagree") to ("strongly agree"). a composite score for each subscale was created by taking the average of the items. higher scores reflect greater germ aversion or perceived infectability. the -item pathogen disgust subscale from the three domains of disgust scale [ ] was used to assess individual differences in disgust sensitivity specifically related to pathogens. participants rated how disgusting they found each item (e.g. "stepping on dog poop") on a -point scale from ("not disgusting at all") to ("extremely disgusting"). a composite variable was created by taking the average of the items (α = . ). higher scores reflect greater pathogen disgust sensitivity. covid- concern. at the time of data collection, there were no existing, validated measures of covid- concern. we developed six items to assess the degree to which participants were concerned about covid- . one item explicitly asked participants to indicate how concerned they were about covid- on a -point scale from ("not at all concerned") to ("very concerned"). for the other five items, participants indicated their agreement with statements regarding the seriousness of the coronavirus (e.g., "the coronavirus is just the flu or a common cold," "people are not doing enough to prevent the spread of the coronavirus") on a scale ("strongly disagree") to ("strongly agree"). necessary items were reverse scored, and all items were standardized. a composite measure was created by taking the average of the standardized items (α = . ). higher scores indicate more concern towards covid- . preventative health behaviors. participants were asked to indicate how frequently they had engaged in behaviors in the past week on a scale from ("not at all") to ("multiple times a day"). a single item assessed the extent to which participants avoided touching their faces. a single item assessed how often participants washed their hands for at least seconds. a single item assessed frequency of wearing an antiviral mask. three items assessed frequency of disinfecting and cleaning frequently touched surfaces (i.e., "clean and disinfect surfaces in your home with antibacterial wipes," "clean your laptop," and "clean your mobile phone"). a composite score was created by taking the average of the items (α = . ). higher scores indicated engaging in each behavior more frequently. five items assessed the extent to which participants avoided contact with others (e.g., "avoid shaking someone's hand for greeting," "avoid going to school/job"). participants were also asked to indicate the extent to which they were engaging in social distancing on a scale from ("not at all") to ("a great deal"). all six items were standardized and a composite measure was created by taking the average of the standardized items (α = . ). higher scores indicate more social distancing. personality. a -item short version of the big five inventory (bfi- ) [ ] was used to assess the big five personality characteristics. each personality trait was assessed with two items. participants rated their agreement on a scale from ("disagree strongly") to ("agree strongly") to statements for openness to experience (e.g., "has an active imagination"; r = . ), conscientiousness (e.g., "does a thorough job"; r = . ), neuroticism (e.g., "gets nervous easily"; r = . ), agreeableness (e.g., "is generally trusting"; r = . ), and extraversion (e.g., "is outgoing, sociable"; r = . ). a composite score for each personality characteristic was created by taking the average of the items. higher values indicate stronger identification with that trait. participants indicated if they thought they have or had covid- by indicating as "yes", "maybe", or "no". for the analyses, the variable was dichotomized. responses of "yes" or "maybe" were coded as , and "no" was coded as . perceived health. participants rated their overall health in general on a scale from ("poor") to ("excellent"). recent illness. illness recency was assessed by asking the participants their agreement with four statements [ ] . using a scale from ("strongly disagree") to ("strongly agree"), participants indicated their agreement to statements, such as "over the past couple days, i have not been feeling well". a composite score was created by taking the average of the items. higher scores indicate more recent illness (α = . ). health history. participants were presented with medical conditions and were asked to indicate whether they and/or a family member ("e.g., your mother, father, sister, brother, aunt, uncle, etc.") had each condition. participants were also asked to indicate if they were taking any immunosuppressive medication and for females if they were pregnant. according to the centers for disease control and prevention (cdc), some individuals are at higher risk for severe illness from covid- [ ] . twenty-two of the medical conditions in the health history questionnaire have been identified by the cdc as placing individuals at risk for severe complications from covid- (e.g., diabetes, dialysis/transplant, cirrhosis), as well as pregnancy and immunosuppressive medication. from this information, a dichotomous variable indicating risk of complications from covid- was created. if participants indicated they had at least one of the medical conditions identified by the cdc, were taking immunosuppressive medication, or were pregnant, they were coded as a participant with high risk of complication from covid- . participants who did not meet any of these criteria were coded . based on health history information, a variable was also created to indicate whether participants had a family member at risk for complications from covid- . if participants indicated that a family member had at least one of the conditions identified by the cdc, they were coded as a participant with a family member at high risk for complications from covid- . participants who had no family members with any of the conditions were coded . political orientation. participants indicated their political orientation on a -point scale from ("very conservative") to ("very liberal"). religiosity. participants indicated the extent to which they were religious on an -point scale from ("not at all religious") to ("extremely religious"). demographics. participants reported their age, race, sex, education level, annual family income, size of town they lived in, and if they were working in a healthcare field. means and standard deviations for all primary study variables are presented in table . bivariate correlations were estimated between the individual characteristics (i.e., demographics, health, social, personality, and bis indicators) and concern about covid- , as well as the preventative health behaviors (see table ). respondents who were older, white, female, more table . bivariate correlations between respondent characteristics and covid- concern and preventative health behaviors. highly educated, at high risk for complications from covid- , had a family member at high risk for complications from covid- , had not recently been ill, never had covid- , were less religious, were more liberal, were more agreeable, conscientious, or open to experience, and were higher in perceived infectability, germ aversion, or pathogen disgust sensitivity reported greater covid- concern. in general, younger age, higher income, more populated location of residence, more recent illness, better perceived health, having/had covid- , greater religiosity, greater extraversion, greater conscientiousness, greater perceived infectability, greater germ aversion, and greater pathogen disgust sensitivity were associated with engaging in most (at least three) of the preventative health behaviors more frequently. of note, however, germ aversion and conscientiousness were negatively associated with wearing an antiviral facemask. also, younger age, more recent illness, having/had covid- , and greater perceived infectability were associated with less frequent handwashing. greater concern about covid- was associated with more frequent engagement in all of the preventative health behaviors, except for wearing an antiviral facemask. concern about covid- was negatively associated with wearing an antiviral facemask. to determine whether bis indicators were uniquely associated with concern about covid- and preventative health behaviors, a series of regression analyses were conducted. bis indicators (germ aversion and pathogen disgust sensitivity) were entered as primary predictors. concern about covid- and preventative health behaviors (social distancing, avoidance of face touching, wearing a facemask, hand washing, cleaning/disinfecting) were entered as primary outcomes. demographic and health characteristics (i.e., age, race, sex, education, income, size of hometown, whether or not one works in healthcare, one's risk of severe illness from covid- , family's risk of severe illness from covid- , illness recency, perceived health, perceived infectability, and history of covid- infection), religiosity, political orientation, and personality (extraversion, openness, conscientiousness, neuroticism, agreeableness) were entered as covariates. for analyses with preventative health behaviors as outcomes, covid- concern was also entered as a covariate. multicollinearity was checked and found not to be a problem (all vif < , tolerance > . ). standardized estimates from regression analyses are presented in table (see s -s tables for unstandardized estimates, standard errors, and confidence intervals for all models). concern about covid- . overall, the model examining individual differences in concerns about covid- was significant, adjusted r = . , f( , ) = . , p < . . older age, higher education, greater perceived infectability, and not having been recently ill were each significantly associated with greater covid- concern. being more liberal, greater conscientiousness, and greater neuroticism were also each significantly associated with greater concern for covid- . after accounting for demographic, health, social, and personality factors, greater germ aversion and greater pathogen disgust sensitivity were each significantly associated with greater concern about covid- . social distancing. overall, the model examining individual differences in social distancing was significant, adjusted r = . , f( , ) = . , p < . . higher income, more recent illness, and better perceived health were each significantly associated with greater social distancing. greater religiosity, greater extraversion, and greater covid- concern were also each significantly associated with greater social distancing. after accounting for demographic, health, psychosocial, and personality factors, greater germ aversion and greater pathogen disgust sensitivity were each significantly associated with greater social distancing. avoidance of face touching. the overall model examining individual differences in avoidance of face touching was significant, adjusted r = . , f( , ) = . , p < . . greater religiosity, more liberal political ideology, and covid- concern were each significantly associated with greater avoidance of touching one's face. after accounting for demographic, health, social, and personality factors, greater germ aversion was significantly associated with avoidance of touching their face. wearing a facemask. overall, the model examining individual differences in wearing a facemask was significant, adjusted r = . , f( , ) = . , p < . . younger age, being male, more populated location of residence, being at high risk for complications from covid- , not having a family member who is at high risk for complications from covid- , more recent illness, and better perceived health were each significantly associated with greater extent of wearing an antiviral facemask. greater religiosity, less conscientiousness, and table . regression model results for covid- concern and preventative health behaviors. less openness were also each significantly associated with greater extent of wearing an antiviral facemask. after accounting for demographic, health, psychosocial, and personality factors, we did not find evidence of a significant association between any bis indicators and wearing a facemask. handwashing. overall, the model examining individual differences in handwashing was significant, adjusted r = . , f( , ) = . , p < . . being female and less recent illness were each significantly associated with more handwashing. greater conscientiousness and greater covid- concern were also significantly associated with more handwashing. after accounting for demographic, health, social, and personality factors, greater germ aversion and greater pathogen disgust were each significantly associated with more handwashing. cleaning/disinfecting. overall, the model examining individual differences in cleaning or disinfecting surfaces was significant, adjusted r = . , f( , ) = . , p < . . younger age, higher income, being at high risk, not having a family member who is at high risk, more recent illness, and better perceived health were significantly associated with more cleaning/disinfecting. additionally, greater religiosity, greater extraversion, and greater covid- concern were each significantly associated with more cleaning/disinfecting. after accounting for demographic, health, social, and personality factors, greater germ aversion and greater pathogen disgust were each significantly associated with greater cleaning/disinfecting. the covid- pandemic represents an unprecedented infectious disease threat to people around the world. the bis is a collection of psychological characteristics thought to serve a disease-avoidance function. the primary goal of the current study was to determine the extent to which individual differences in the bis were uniquely associated with covid- concern and covid- -related preventative health behavior. when demographic, health, social, personality, and bis variables were considered simultaneously, greater germ aversion and pathogen disgust sensitivity were most consistently associated with covid- concern and preventative behaviors. these findings are consistent with bis theory and suggest potential targets for health promotion interventions. both germ aversion and pathogen disgust were uniquely associated with greater concern for covid- . additionally, greater germ aversion was connected with greater engagement in all preventative health behaviors, except wearing a facemask, and greater pathogen disgust sensitivity was associated with more social distancing, handwashing, and cleaning/disinfecting. notably, the effect sizes of the associations between germ aversion and preventative health behaviors were comparable to the effect sizes of the relations between covid- concern and preventative health behaviors. these findings are consistent with recent work linking bis indicators with covid- related behavioral intentions and policy attitudes [ , ] . in general, these findings support theory suggesting the protective function of psychological diseaseavoidance mechanisms during a time of real disease threat [ ] . the pattern of findings were relatively consistent across preventative health behaviors, except for wearing an antiviral facemask. recommendations regarding facemasks have varied during the pandemic. at the time of data collection, the cdc only recommended wearing a facemask if individuals thought they had covid- , and people were dissuaded from wearing antiviral (e.g., n ) facemasks in order to prevent shortages of such personal protective equipment at hospitals and for healthcare workers [ ] . on april , (after data collection), the cdc recommended that everyone should wear a cloth facemask in public or when around others [ ] . the lack of significant associations between facemask wearing and bis indicators or covid- concern, as well as significant negative associations with other variables (e.g., conscientiousness, age), may reflect that wearing facemasks, especially antiviral facemasks, was not recommended at the time. the present study also provided a comprehensive test of the extent to which a large range of demographic, health, and psychosocial variables were related to covid- responses. older age was associated with more concern about covid- , which is understandable as older adults are at higher risk of complications from covid- [ ] . however, this concern did not translate into greater engagement in preventative health behaviors. in fact, older age was associated with less cleaning/disinfecting behavior and utilization of antiviral facemasks. potentially, older adults were self-isolating more and thus had less need to engage in these behaviors. greater income was associated with more social distancing and cleaning/disinfecting behavior. greater financial resources may facilitate the ability to engage in these practices, such as working from home and having access to disinfecting supplies. recent illness and general perceived health were also associated with many preventative health behaviors. well-being may be more salient for these individuals, but the underlying motivations may differ. for the former, engaging in preventative health behaviors may be motivated by wanting to protect others from getting sick. indeed, those who had been ill recently were less concerned about covid- , but recent illness was the variable most strongly associated with wearing antiviral facemasks. individuals who perceive themselves as having generally good health may be motivated to maintain their health and engage in preventative health behaviors to reduce the likelihood of getting sick themselves. unlike previous work [ ] , political orientation was not reliably associated with preventative health behavior in this nationally-representative sample. although those who were more liberal endorsed greater concern about covid- , we did not find evidence that political ideology was independently associated with greater engagement in preventative health behaviors, other than greater avoidance of touching one's face. in our study, we considered a broader range of demographic, health, and psychosocial factors than kushner gadarian et al. [ ] , which may account for the differences in results. greater religiosity was also associated with engaging in all of the preventative health behaviors, except for handwashing. although the empirical evidence is mixed, religiosity has been proposed to encourage prosocial behaviors [ ] , so these results could reflect prosociality if engaging in preventative health behaviors is for the benefit of others. religiosity has also been associated with greater social conformity [ ] . thus, these findings may be due to religious individuals' greater sensitivity to social norms. consistent with the existing literature, conscientiousness and neuroticism were associated with greater concern about covid- . however, personality traits were not consistently related to engaging in preventative health behaviors when accounting for demographics and other psychosocial variables. in times of infectious disease threat and the unique situation of a pandemic, traditional personality traits may be a lesser determinant of behavior. rather, personality traits may be more strongly associated with regular daily activities and lifestyle choices (e.g., physical activity, alcohol consumption). the behavioral immune system is theorized to promote the avoidance of pathogen threats. some cross-cultural research indicates group differences in bis reactivity due to differences in historic and contemporary parasite or disease prevalence rates associated with geographic locations [ , ] . however, most of the bis research has been conducted in lab-based settings using artificial tasks designed to prompt disease threat [ ] . the current study extends this body of evidence and further supports bis theory by demonstrating that individual differences in germ aversion and pathogen disgust sensitivity were associated with responses to a real-world, contemporary pathogen threat. such an extension provides important ecological validity to lab-based and historical research. findings from this study have implications for policy and public response to future epidemics or pandemics. our results identify a variety of demographic and psychosocial characteristics that may place individuals at-risk for contracting and spreading disease during pandemics. designing efficacious messaging that targets these populations may help optimize alterations in human behavior necessary to prevent the spread of infectious diseases. for instance, in addition to focusing on the severity of infection, it may be beneficial for messages about covid- to emphasize aspects of the virus and disease that activate the psychological disease-avoidance processes. for example, messages could incorporate images or language that induce feelings of disgust or make salient the presence of germs or contamination. although individuals reliably differ in these psychological traits, there are malleable components to the diseaseavoidance processes that can be activated, leading to behavior change [ ] . thus, it may be important for future research to examine whether temporarily increasing disgust or germ aversion promotes pandemic-related health behaviors. results from this study should be taken in light of certain limitations. the data are cross-sectional preventing causal claims; however, the wide range of demographic and psychosocial variables considered reduces the possibility of third variables. of course, other variables not assessed in the current study may still account for the findings. theoretically, germ aversion and pathogen disgust sensitivity motivate concern about infectious disease and engagement in preventative health behaviors. experimental evidence indicates that inducing disgust results in greater avoidance behavior, reducing potential contact with pathogens [ ] . however, we cannot rule out the opposite causal relation with the current data. greater concern about covid- may lead to increased germ aversion and pathogen disgust sensitivity. experimental or longitudinal data are necessary to determine the causal direction. all variables were assessed with self-report measures, which raises concerns of social desirability or biased responding. at the time of data collection, there were no publically available measures of covid- concern, so we developed our own measure. although reliable and the items were deemed to be face valid by the research group, the covid- concern measure was not validated. also, data were collected online. although a nationally representative sample was recruited, only individuals with reliable internet access, computer, or smartphone were able to complete the study, thus limiting generalizability. our study has highlighted several factors associated with concern about covid- and engagement in preventative health behaviors. further research is needed to test these associations prospectively. these findings identify those who may be at greater risk of contracting and spreading covid- , or future infectious diseases, as well as provide potential 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handbook of evolutionary psychology individual differences in sensitivity to disgust: a scale sampling seven domains of disgust elicitors microbes, mating, and morality: individual differences in three functional domains of disgust perceived vulnerability to disease: development and validation of a -item self-report instrument moral values and trait pathogen disgust predict compliance with official recommendations regarding covid- pandemic in us samples perceived vulnerability to disease predicts restrictive policy supports in response to the -ncov outbreak religiousness and lifestyle among europeans in share does personality predict health and well-being? a metasynthesis neuroticism and health as individuals age partisanship, health behavior, and policy attitudes in the early stages of the covid- pandemic disease avoidance and personality: a meta-analysis the behavioral immune system and social conservatism: a meta-analysis behavioral immune system methods: surveying the present to shape the future how to protect yourself vulnerability to disease as a predictor of faster life history strategies behavioral immune system activity predicts downregulation of chronic basal inflammation measuring personality in one minute or less: a -item short version of the big five inventory in english and german sick body, vigilant mind: the biological immune system activates the behavioral immune system people who need to take extra precautions evolution and the social mind: evolutionary psychology and social cognition god we trust? neural measures reveal lower social conformity among non-religious individuals. social cognitive and affective neuroscience pathogen prevalence predicts human cross-cultural variability in individualism/collectivism the parasite-stress theory may be a general theory of culture and sociality. behavioral and brain sciences testing the relation between disgust and general avoidance behavior. personality and individual differences conceptualization: natalie j. shook. key: cord- -qtq w authors: graham, kathleen; connolly, maureen title: health systems planning for an influenza pandemic date: - - journal: healthc manage forum doi: . /s - ( ) - sha: doc_id: cord_uid: qtq w district planning, in general, and influenza pandemic planning, in particular, are necessary to sustain health care organizations and systems. an extensive stakeholder process used by capital district health authority (cdha) and the izaak walton killam (iwk) health centre involved more than teams. this work resulted in a joint cdha/iwk pandemic influenza contingency plan for public health, primary care, acute care and tertiary care services. in addition, district and business continuity planning has been enhanced. t is not uncommon to hear, "don't worry, we have a disaster plan," when asking about a response to pandemic or other extended emergency situations. however, organizational disaster plans are likely limited in their responsiveness to pandemic or other crises. one need only consider the impact and aftermath of severe acute respiratory syndrome (sars) or the unfolding story in new orleans to begin to appreciate the extent of devastation and unprecedented changes in both the types and volumes of services that communities and health care organizations may face while simultaneously dealing with reduced resources. organizational effort expended to develop a robust systemic plan is more than an investment in flu contingency planning. it is an investment in capacity building. the capital district health authority (cdha) and izaak walton killam (iwk) health centre are independent organizations serving adults and children in the regional municipality of halifax, nova scotia. they provide tertiary and quaternary services to the maritimes and beyond. the cdha/iwk pandemic influenza contingency plan (picp) is intended to enable an effective district response. specific objectives include: description of the command, control and management structure and functions, enhancement of surveillance systems, development of a communications plan, operational procedures for vaccines and anti-viral administration and delivery, and service delivery plans for acute care, emergency services and public health measures during a pandemic. to date, pandemic plans at the district and local level vary. cdha/iwk and the nova scotia (ns) department of health (doh) have been concurrently developing pandemic contingency plans, with the district focusing on health services operational delivery and the ns doh developing provincial policy to promote consistency for health services delivery. pandemic influenza conceptual planning framework there are two universal goals in a pandemic: . to reduce the burden of illness and excess deaths, and . to minimize the disruption to society. for this project, we adopted the world health organization (who) phases, canadian phase terminology and several of the canadian pandemic influenza plan (cpip) ( ) planning assumptions. there are no standard "triggers" to initiate local responses during an influenza pandemic. the canadian phase terminology does not include the end of the first pandemic wave, the interval between waves or the onset of a second pandemic wave. we refined the phases for clinicians, support staff and planners to ensure a common framework. the resulting clinical services delivery plan was a step-wise approach activated by a series of specific trigger points, which are defined as points in time when certain events activate responses (e.g., reduce surgeries). to promote consistency, timing and alignment of response activities in health services planning, each clinical service plan used a generic template and added assumptions, response activities and surge capacity results. figure illustrates the conceptual framework for cdha/iwk pandemic influenza contingency planning framework. adapting and building on a pandemic influenza contingency planning exercise conducted in albany, new york, during an influenza pandemic, there will be high rates of both community illness and illness among health care workers, and increased demand for medical services. this will result in an imbalance between the supply of and demand for medical services. an "all-hazards" plan is a unified, operational plan with strategies built on existing procedures for disaster planning and emergency preparedness. using an "all-hazards" approach to pandemic influenza contingency planning, the following two key questions should be posed: ) what is the impact on population health and the health system? who is affected, how and to what extent? ) how do we match population health care needs to appropriate available resources for service delivery within our communities? what are the possible solutions? the following discussion is organized around these two central questions. the centre for disease control (cdc) software, fluaid and flusurge, was used to model the potential impact of an influenza pandemic on our population's health and on the health system. influenza planning projections require con- sideration of highly variable epidemiologic factors, including attack rate, morbidity and mortality, rate of spread and duration of wave(s). the projections are likely understated, since cdha/iwk provide tertiary and quaternary services to a broader population. using a % attack rate and assuming % of the population are at high risk, fluaid output results for a population approximating , in cdha/iwk yielded: • , to , outpatients (emergency department and family practice/general practice (fp/gp) clinics), • to , hospitalizations, and • to deaths. while the focus of this paper is on acute care delivery, three other component areas, public health, emergency preparedness and response and communications, are under development as follows: the public health working group is identifying appropriate public health measures (phm), determining how to operationalize these measures and assessing resource requirements to implement mass immunization, phm and public education. the surveillance/laboratory working group is examining how to enhance surveillance information (e.g., fluwatch), developing rapid lab diagnostic testing and reporting, and planning for lab and surveillance surge capacity. the anti-virals and vaccine working groups are developing plans for the supply, distribution and use of anti-virals and vaccines, establishing priorities for access and mass vaccine immunization and developing monitoring tools to oversee anti-viral use and adverse impact(s). the emergency preparedness and response working group has established roles and responsibilities and enhanced linkages with external resources (e.g., ns department of community services, doh, emergency health services, department of national defence, municipalities, universities and colleges, the local chamber of commerce and others). the group is conducting a site selection process for community-based assessment centres, immunization sites and alternative care (sub-acute and palliative care) sites. the communications working group has developed a toolkit for leaders/managers to communicate pre/pan/post-pandemic to public, media, staff, government and other stakeholders. they have built on risk communication principles and developed a spokesperson(s) roster system. primary care services will likely see influenza pandemic impact first, and may be at greater risk of becoming overwhelmed early in an outbreak. planning for traditional hospital and health services, while overlooking primary care, would be to everyone's detriment. more than half of the people who acquire influenza will require some form of outpatient or primary care. table shows the estimated impact on the capital district over an eight-week period, assuming % of the pop- ulation is affected. an estimate of the number of outpatient medical consults and the number of additional flu consultations per "healthy" fp/gp per week is indicated. this latter calculation was done recognizing that practitioners will be ill themselves, covering for group practices and potentially staffing assessment centres. using flusurge . , table outlines the demand for cdha/iwk's hospital-based resources. at the peak of an eight-week outbreak with a % attack rate, there would be influenza-related hospital admissions per week and deaths per week ( occurring in hospital). based on this modeling, influenza patients will utilize % of hospital bed capacity, % of icu capacity and % of ventilator capacity. the second key question of how best to match population health care needs to appropriate resources for delivery of services relates to strategies for preparation, response and recovery. disaster planning solutions are multi-faceted and involve the simultaneous pursuit of two pathways: . minimizing the impact on population health and the health system by: a. reducing demand on the health care system, by encouraging the public to self-diagnose and treat their own influenza-like illness (ili), b. minimizing spread of transmission by "cohorting" patients with suspected influenza, c. implementing non-medical and medical interventions to minimize morbidity and mortality. the former includes public health measures, surveillance, infection control and communications. medical interventions include vaccine and anti-virals. c. reducing "elective activity" across the continuum of services by: i. deferring surgeries and ambulatory care, ii. pre-arranging chronic disease management plans, including service delivery in alternative care settings, iii. expediting early discharges from hospitals and judiciously using family, home care and volunteer services, iv. encouraging patients with stable chronic illnesses to defer seeking medical care for those illnesses in primary care. in february , a project manager was hired to coordinate the project. this initiative was jointly funded and its ongoing sponsorship came from the clinical vps of the cdha and the iwk. in march , more than individuals from cdha/iwk attended a workshop in edmonton, thereby enabling them to obtain a collective understanding of the status of their counterparts, establish contacts and discuss best practices for pandemic planning in large urban centres. one presenter likened the challenge of contingency planning efforts to a "herding of cats." this insight provided a level of comfort and reassurance in addressing the obstacles encountered along the way. this core group formed a critical pool of local advocates. we realized that we could not produce a collaborative, comprehensive plan if the planning process was not unfolding as it should and we did not have the appropriate subject matter expertise. a combination of project management, change management and knowledge transfer tools were designed into the process. active and visible executive sponsorship was obtained in the form of funding, oversight meetings, communications and participation in major workshops. project management techniques were used to identify and prioritize what was doable. project committee and working groups were restructured. common templates for work plans and pandemic response plans were developed, and mechanisms for ongoing performance monitoring and evaluation were implemented throughout the project. the cdha/iwk pandemic influenza plan became a documentation of decisions made as we journeyed through a process. change management was used to unfreeze the status quo and introduce new thinking into corporate cultures. large-scale workshops enabled education and created a sense of urgency and resource commitment. the project plan was formalized and communicated through a project charter. champions were recruited. the creation of or more work groups empowered and engaged a broad base. this active participation promoted a sense of ownership. interim presentations by work group leaders and the sharing of iterative draft plans enabled knowledge transfer. the interactive exer-cising of plans in workshops provided invaluable education, team building and motivation. the importance of involving people and sharing their expertise cannot be overstated. the following series of events occurred with clinicians, including physicians, as part of the stakeholder engagement process. in september , there was a workshop for the planning and design of a common engagement with the facilitation of an external consultant. pre-workshop activities were assigned to each team to capture a descriptive understanding of their "as is" status of how they were operating at that time. figure illustrates the resulting organizational structure for delivery of this initiative. -a two-day session was held in october , attended by more than people from communications, public health, emergency preparedness, health and support services, government and the community. -the planning session objectives were to: -provide a "common" understanding of what a pandemic looks like, its phases, and what we can reasonably expect, -identify system-level response(s) by pandemic phase(s), -obtain agreement on planning assumptions, -develop a work plan and determine lead responsibility and resources for essential activities to produce a cdha/iwk pandemic plan. by mid-november , multiple working groups were tasked with developing draft plans for response strategies and preparedness activities. a series of guidelines, tools and templates from project management to business and service continuity were developed. table contains a sample guideline used to assist work groups' "creative thinking" in developing service-delivery plans. for physician-specific input, the medical advisory committees (macs) at cdha and iwk were provided a template for each department and division to complete. key elements included: ) business/service continuity; ) chronic disease management; ) hr mobilization/cross-training and reassignment; and ) ethical and legal framework. a compilation and validation process followed receipt of work group draft plans in the spring of . draft plans were compiled and work group leaders were invited to a session to share their planning assumptions, response activities, outstanding issues and gaps. a highly interactive day-long session was attended by -plus participants. each of the plans was "tested" by an exercise that engaged participants in a series of injected events based on local triggers established over the timeframe of a pandemic. each group was tasked with communicating their needs to others, identifying issues and negotiating resolutions. outstanding issues were brought to an executive group for resolution and followup by the oversight steering committee. workshop outputs included a log of all communications between groups, issues with resolutions and outstanding issues, including gaps. a matrix of each group's key response activities over the timelines of a pandemic was produced to verify alignment. the day workshop evaluation results affirmed the interest in and tremendous success of this initiative. based on an % response rate, % of participants "strongly agreed" or "agreed" that the workshop and the overall planning were worthwhile and useful. a compendium of pandemic plans for -plus groups exists as part of the cdha/iwk pandemic influenza contingency plan. an executive summary is being developed, which will include the clinical surge capacity results and templates for beds, services prioritization and human resource needs by staff type. another noteworthy output was the development of proposed patient flow and medical treatment for the cdha/iwk population during a pandemic. challenges and lessons learned • structures and potential silos - st major joint planning exercise between iwk and cdha, -iwk and cdha have responsibility for public health, primary care and acute care, -long-term care and home care are not within our mandates. • direction and resources -federal plan provided very broad guidelines and provincial plan was under development, -staff had competing priorities and this work required significant time commitment, -dedicated project manager was essential. • scope and complexity -earlier smaller-scale planning attempts left people cautious to commit, -iterative nature ultimately resulted in more than working groups, -planning the services was the easier task, while broader ethical concerns are more challenging, -decision-making in an extended disaster requires different structures and processes for command and control. our military colleagues and the municipal emergency measures organization staff provided invaluable expertise, -as pandemic planning evolved, our focus shifted from individual patients to communities, from a short-term to a multi-phased, long-term outbreak, from a traditional disaster planning approach to an all-hazards plan and broader business continuity planning. the collaborative and iterative process provided experiential learning about disaster preparedness and business continuity planning for more than inter-disciplinary key stakeholders. the development of pandemic plans by more than working groups covered clinical services and resource management for major hospital sites providing acute, secondary and tertiary and quaternary care. the best of plans would not have created these results without the dedication and commitment of all participants. the methodology provided unique opportunities for collaboration, creativity and innovation. use of change management and knowledge transfer principles and concepts enabled successful generation of a product greater than the sum of its component parts. use of project management tools and templates enabled consistency of language and development of plans across multiple cross-functional clinical and non-clinical areas. the use of an all-hazards approach for disaster planning coupled with the application of business continuity planning templates resulted in an emergency preparedness plan and process that is generic and complementary to an all-hazards planning approach. the plan is currently being transitioned from the oversight steering committee to the cdha/iwk all hazards emergency preparedness and response group. it continues to evolve in an iterative manner. available from: www.health.gov.on.ca/english/public/pub/ministry_reports/ca mpbell /campbell .html . who global influenza preparedness plan: the role of who and recommendations for national measures before and during pandemics. department of communicable disease surveillance and response global influenza program, world health organization the canadian pandemic influenza plan for the health sector, section , background. public health agency of canada canadian pandemic influenza plan. public health agency of canada albany medical centre regional resource centre for emergency disaster preparedness, and champlain valleys physician hospital regional resource centre federal/provincial/territorial network on emergency preparedness and response. national framework for health emergency management: guideline for program development the economic impact of pandemic influenza in the united states: priorities for intervention. department of health and human service available from: www .cdc.gov/od/fluaid a guide to the project management body of knowledge -third edition the heart of change influenza pandemic: continuity planning guide for canadian business, canadian manufacturers and exporters the authors wish to acknowledge the commitment and expertise of the many staff at capital health and the iwk health centre who are participating in the cdha/iwk pandemic influenza contingency planning. key: cord- - etqt authors: mcclure, elizabeth s; vasudevan, pavithra; bailey, zinzi; patel, snehal; robinson, whitney r title: racial capitalism within public health: how occupational settings drive covid- disparities date: - - journal: am j epidemiol doi: . /aje/kwaa sha: doc_id: cord_uid: etqt epidemiology of the u.s. covid- outbreak focuses on individuals’ biology and behaviors, despite centrality of occupational environments in the viral spread. this demonstrates collusion between epidemiology and racial capitalism because it obscures structural influences, absolving industries of responsibility for worker safety. in an empirical example, we analyze economic implications of race-based metrics widely used in occupational epidemiology. in the u.s., white adults have better average lung function and worse hearing than black adults. both impaired lung function and hearing are criteria for worker’s compensation, which is ultimately paid by industry. compensation for respiratory injury is determined using a race-specific algorithm. for hearing, there is no race adjustment. selective use of race-specific algorithms for workers’ compensation reduces industries’ liability for worker health, illustrating racial capitalism operating within public health. widespread and unexamined belief in inherent physiological inferiority of black americans perpetuates systems that limit industry payouts for workplace injuries. we see a parallel in the epidemiology of covid- disparities. we tell stories of industries implicated in the outbreak and review how they exemplify racial capitalism. we call on public health professionals to: critically evaluate who is served and neglected by data analysis; and center structural determinants of health in etiological evaluation. "mr. floyd is over six feet tall and weighs more than pounds... floyd had underlying health conditions including coronary heart disease and hypertensive heart disease. the combined effects of mr. floyd being restrained by police, his underlying health conditions and any potential intoxicants in his system likely contributed to his death." --criminal complaint against derek chauvin by the state of minnesota, hennepin county, may , ( ) "… [t]he manner of mr. floyd's death was caused by asphyxia due to neck and back compression…. sustained pressure on the right side of mr. floyd's carotid artery impeded blood flow to the brain, and weight on his back impeded his ability to breathe… '[h]e would be alive today if not from the pressure applied to his neck by fired officer derek chauvin and the strain on his body from two additional officers kneeling on him'." --benjamin crump, esq. "independent medical examiners determined #georgefloyd's death was due to asphyxia from sustained forceful pressure. full statement:" jun , ( ) the racialized use of individual-level risk factors is starkly evident in the aftermath of george floyd's recent murder. we see how scientific evidence is used to attribute risk to floyd's individual biology, in the form of the now familiar racial refrain of "underlying health conditions," as well as risky behavior on the part of the deceased whose physiological response to physical violence is presumed to have involved "potential intoxicants," shifting the cause of death away from police violence. the same racialized narrative is prominent in the medical literature on covid- . the attribution of increased acquisition risk to individual-level etiologiesincluding higher rates of comorbidities and socio-cultural differences such as health-seeking behavior and intergenerational cohabitation ( )overshadow differential transmission related to structural factors ( ), in particular, work environments. in this commentary, we tell stories about illness and work. we argue that the most salient commonality among exacerbates covid- risk for these worker populations, through replication of historical inequities and state-supported corporate neglect of worker protection ( , ) . moreover, we argue that epidemiology as a discipline has selectively produced and promoted quantitative findings to justify and further this system of racial capitalism. the inequities evident in the ongoing covid- pandemic offer an opportunity to redress our role in producing racially disparate health outcomes. how does epidemiology support the interests of racial capitalism? in her scholarship on the history of race and medicine, dr. dorothy roberts describes how focusing on "underlying" health conditions and behavioral risk factors allows society "[a] to ignore how disease is caused by political inequality and [b] to justify an unequal system by pointing to the inherent racial difference that disease supposedly reveals" ( ) . under racial capitalism, attention is drawn away from workplace hazards by arguing that workers are inherently at high risk of ill health due to their own racial and behavioral susceptibilities, masking and justifying how labor is structured to concentrate risky, lowwage work among non-white or otherwise marginalized workforces. contemporary, "mainstream" epidemiology's technocratic focus on individual-level biological and behavioral risk factors ( ) ( ) ( ) readily supplies data used to justify high levels of ill health observed among of low-wage workers. in particular, "mainstream" epidemiology colludes with racial capitalism by producing disproportionately more work documenting individual-level susceptibility than it does investigating more plausible alternative workplace-level explanations for workforce disparities ( ) . moreover, as we demonstrate in the empirical case study below, much of "mainstream" work in epidemiology is structurally racist in that it serves to reinforce and, post hoc, justify pervasive narratives of biological and cultural inferiority of black and brown people ( ) . the collusion of epidemiology with racial capitalism is particularly insidious because racial capitalism can leverage statistical methodology that is perceived as objective to hide even obviously racist distributions of health ( , ) . below we present an example from occupational health that demonstrates how epidemiologic data is strategically used to downplay the effects of occupational exposures on poor health and thus minimize financial exposure of the corresponding industries. lung function and hearing loss are metrics commonly monitored in manufacturing industries due to occupational safety and health administration (osha) regulations ( , ) . these metrics are proxies of health impacts of hazardous work environments in manufacturing settings ( ) . moreover, lung impairment and hearing loss are frequent grounds for workers' compensation claims ( ) . workers' compensation is a legal process in which workers file claims in relation to illness and injury resulting from job tasks and exposures. compensation is paid by industry when the court rules in favor of the worker ( ) . therefore, strategies that minimize identification of worker injuries directly benefit the owners of and investors in the businesses employing those workers. in the united states, on average, black adults tend to have worse lung function but better hearing than white adults ( , ) . seminal epidemiologic analyses of the national health and nutrition examination survey (nhanes) iii ( - ) concluded that lung function among "african-americans" is - % lower than among "caucasians" ( ) . the epidemiologic data indicate the opposite for hearing. numerous u.s. cohort studies, have concluded that black adults tend to have better hearing than white adults (and females tend to have better hearing than males) ( ) ( ) ( ) ( ) . epidemiologic studies suggest that the minimum noise levels must be to percent louder to be detected by white americans compared to black americans ( , ) . workers qualify for compensation only when they reach a set level of impairment. for lung function, workers are typically eligible for compensation when their lung capacity performance is lower than % of their predicted lung capacity. a similar time period to the niosh data. we restricted the sample to respondents aged to years who reported "ever having job exposure to loud noise" ( ) . we estimated the percent of workers who meet the respective thresholds for a disability claim under two conditions: ( ) the current standard and ( ) a counterfactual scenario in which race adjustments were (hearing) or were not (lung function) used. for the counterfactual hearing loss condition, we applied a conservative % decrement to white workers, based on age-adjusted population estimates ( , ) . for the counterfactual lung function condition, we eliminated the race correction from the predicted lung function equation. using the current algorithms for predicted lung function, % of white workers and % of black workers' qualify for compensation. when applying an algorithm to black workers that is not race corrected, % of the black workers would qualify for compensation. using the current, non-race corrected algorithm for predicted hearing, % of white workers and % of black workers would qualify for compensation. when imposing a race-specific adjustment for white workers, only % of white workers would qualify. in all four scenarios in figure our analysis of workers' compensation claims makes explicit one mechanism by which racial capitalism enriches industries. in the counterfactual scenario of no black lung function correction but a white hearing correction, industry would owe % more in worker's compensation payouts (this calculation is based on applying the average payout associated with each workers' compensation award in a typical state ( )). of course, applying a black race correction to lung function and a white race correction to hearing would theoretically reduce industry payouts even more. so why are race corrections for lung function uncontested, standard practice in occupational regulations and occupational epidemiology research ( , ) , while race corrections for hearing are not? first, as shown by the % statistic above, the black race correction is more profitable to industry than a white race correction. under racial capitalism, black workers experience more work-related health damage because they are concentrated in riskier, less protected jobs. therefore, "corrections" that understate the extent of their damaged health will be disproportionately more valuable to industry than corrections that understate workplace impacts on less exposed populations. second, consistent applications of race corrections would undermine the narrative of inherent black biological inferiority that helps make racial capitalism so profitable. exposing the fact that black workers in high-noise jobs experience more hearing impairment even though a race correction is applied to account for the typically worse hearing of white adults makes more obvious the likelihood that the greater hearing damage observed among black workers is actually because of the workplace setting. that logical connection in turn suggests that other health harms disproportionately experienced by black workers are also because of the organization of work. we end this section with a note about epidemiology's complicity with racial capitalism in regard to damage to hearing and lung function. as we've described above, the field of epidemiology has published and promoted the use of race-"corrected" equations for whatever the intentions of these analytic and dissemination decisions, the overall impact of this body of epidemiologic research is to reinforce a narrative of black workers' biological inferiority, increasing the financial gains that industries can reap by using racial capitalism as an organizational strategy. next we briefly discuss key industries implicated in the spread of the sars-cov- virus in the u.s. we group the work settings by the demographic compositions of the workers or the clientele served. applying theories of racial capitalism and inverse hazard law, we argue that the risks associated with these workplaces are highly patterned by race/ethnicity and immigrant status. from farmworkers to meatpackers to supermarket chain employees and food delivery workers, the extreme vulnerability of labor forces across the food production system demonstrates that while industrial agriculture work is considered essential, the workers themselves are treated as expendable ( ) . moreover, the concentration of u.s. the construction industry employs nearly million workers with an estimated % of construction workers being undocumented, though this is likely an underestimate. austin, texas, is home to an estimated , construction workers, about % of whom are undocumented and more than % of whom make below poverty-level wages ( ) ( ) ( ) . despite early orders by local government declaring construction workers "non-essential" and subject to stay-at-home orders ( ) , and despite an epidemiologic study identifying significant risk of hospitalization from covid- if construction workers were to resume work ( ) , under the influence of building and real estate industries the state governor quickly intervened with a statewide order deeming all construction work as "essential" ( ) . by early april it was clear that construction workers, latinx workers in particular, were falling sick and being hospitalized from covid- at disproportionately higher rates than the general public ( ) ( ) ( ) . the majority of cluster cases in austin were linked to construction work sites and surveillance testing for coronavirus among construction workers yielded a positive rate of approximately . times the average rate at drive-through surveillance sites ( ) . the flawed dominant narrative blames workers in this industry by attributing high disease transmission to multigenerational households, inadequate personal hygiene and poor health literacy ( ) . however, despite city-wide requirements for construction employers to support strict physical distancing guidelines and personal hygiene recommendations, no oversight mechanism exists and workers report ongoing lack of access to personal protective equipment ( ) . carceral facilities differ from the other workplaces described above in that a predominantly white workforce oversees a disproportionately black and latinx population ( ) . we include these facilities here because jails, prisons, and ice detention centers are major sites of sars-cov- transmission ( ) ( ) ( ) . we recognize that the disparities in incidence and mortality related to covid- stem from centuries of u.s. industrial development which depends on structural racism to thrive ( ). our analyses have salience beyond the scope of this outbreak. as with all diseases for which workplace environment is a root cause, the most marginalized workers with the least power and resources (e.g. undocumented residents, incarcerated individuals, people of color, women, lgbtq individuals) are least likely to have access to testing for infectious diseases and most likely to be missed in cohort enumeration ( ) . during the covid- outbreak, public health institutions are not collecting and/or suppressing complete testing, workplace, and demographic information ( , ) . despiteor perhaps because ofunderlying risks, decision-makers have been reluctant to release data regarding covid- cases, deaths, and hospitalizations associated with nursing homes, with some going as far as insinuating it was "bad for business" ( , ) . at minimum, all covid- researchers in the u.s. should routinely collect data on occupation and stratify data summaries by race, ethnicity, and gender whenever possible. at the least, we must strive toward a field of inquiry in which political influence does not compromise public health practice. we urge covid- researchers and public health professionals more broadly to engage with occupational hazards as root causes of diseases and disparities. one of epidemiology's founding legends is john snow's removal of the broad street pump ( ) . would we be talking reverentially about john snow if he'd done a study of individual-level risk factors for cholera death among those admitted to the regional hospital? ford and airhihenbuwa's public health critical race praxis calls on public health professionals to question the ways in which we recreate racism through our study designs, information collection, research questions, and data analysis methods ( ) . by ignoring and misrepresenting root causes of poor health among workers, we absolve industries and government leaders of their responsibility for equitable health protection. in the midst of the covid- crisis, we have an opportunity to critically evaluate our methods and take measurable steps toward promoting social justice and health equity. independent medical examiners determined #georgefloyd's death was due to asphyxia from sustained forceful pressure ethnicity and covid- : an urgent public health research priority. the lancet racism and the political economy of covid- : will we continue to resurrect the past? abolition in the time of covid- . antipode online [electronic article racial capitalism: a fundamental cause of novel coronavirus (covid- ) pandemic inequities in the united states black marxism : the making of the black radical tradition environmental racism, racial capitalism and state-sanctioned violence understanding covid- risks and vulnerabilities among black communities in america: the lethal force of syndemics employed persons by detailed industry, sex, race, and hispanic or latino ethnicity coronavirus guidelines for america indigenous groups are taking on governments over coronavirus failures work-based risks to latino workers and their families from covid- | econofact unequally vulnerable: a food justice approach to racial disparities in covid- cases covid- in racial and ethnic minority groups physicians' risk from covid- : a reassuring statistic the inverse hazard law: blood pressure, sexual harassment, racial discrimination, workplace abuse and occupational exposures in us low-income black, white and latino workers world health organization. rational use of personal protective equipment (ppe) for coronavirus disease (covid- ): interim guidance percentage of all active physicians by race/ethnicity fatal invention: how science, politics, and big business re-create race in the twenty-first century limits of epidemiology. medicine and global survival epidemiology and the people's health racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites structural racism and health inequities in the usa: evidence and interventions. the lancet white logic, white methods: racism and methodology how to be an antiracist safety and health topics | occupational noise exposure | occupational safety and health administration pulmonary function testing training requirements and spirometer transmission of disease. | occupational safety and health administration respiratory symptoms and lung function of aluminum potroom workers. scandinavian journal of work, environment & health compensation: benefits, coverage, and costs spirometric reference values from a sample of the general u.s. population. american journal of respiratory and critical care medicine race and sex differences in age-related hearing loss: the health, aging and body composition study association of skin color, race/ethnicity, and hearing loss among adults in the usa prevalence of hearing loss and differences by demographic characteristics among us adults: data from the national health and nutrition examination survey race difference in susceptibility to noise-induced hearing loss. the american journal of otology estimating the effect of occupational noise exposure on hearing thresholds: the importance of adjusting for confounding variables ama guides to the evaluation of permanent impairment guides to the evaluation of permanent impairment, th edition -division of federal employees' compensation (dfec) -office of workers' compensation programs (owcp) -u.s. department of labor software -niosh workplace safety and health topic national health and nutrition examination survey data: audiometry data lung function testing: selection of reference values and interpretative strategies comparison of smoking history patterns among african american and white cohorts in the united states born to covid- among workers in meat and poultry processing facilities - states territorial stigmatization in action smithfield foods is blaming "living circumstances in certain cultures" for one of america's largest covid- clusters building austin, building justice: immigrant construction workers, precarious labor regimes and social citizenship building a better texas: construction working conditions in the lone star state build a better nation: a case for comprehensive immigration reform stay home -work safe order information covid- in austin, texas: epidemiological assessment of construction work work session of the austin city council, item b -briefing on matters related to covid- coronavirus in austin: virus clusters showing up in construction, other industries austin health officials seeing spike in covid- cases among construction workers crowded housing and essential jobs: why so many latinos are getting coronavirus essential during the pandemic. workers worry their health is not mitigating the wider health effects of covid- pandemic response occupational prestige in the health care delivery system hospitals tell doctors they'll be fired if they speak out about lack of gear. fortune [electronic article these are the occupations with the highest covid- risk three new york city hospital workers died from coronavirus weeks after handing out masks. people.com [electronic article covid- nursing home data observational evidence of for-profit delivery and inferior nursing home care: when is there enough evidence for policy change? racial disparities in job strain among american and immigrant long-term care workers changes in nursing home staffing levels from servitude to service work: historical continuities in the racial division of paid reproductive labor bad state data hides coronavirus threat as trump pushes reopening the forgotten front line: nursing home workers say they face retaliation for reporting covid- risks state-reporting-of-cases-and-deaths-due-to-covid- -in-long-term-carefacilities/) economic vulnerability among us female health care workers: potential impact of a $ -per-hour minimum wage covid- cases at one texas immigration detention center soared in a matter of days. now, town leaders want answers perspective | unions for prison, va workers file "imminent danger" reports about coronavirus conditions something is going to explode': when coronavirus strikes a prison. the new york times bop: covid- update nurse dies. angry co-workers blame a lack of protective gear. the new york times hospital workers gave out masks. weeks later, they all were dead. the new york times florida governor defends firing of top data scientist revealing nursing homes with covid- outbreaks would hurt businesses. azcentral state won't name nursing homes where seniors are dying because it's .... bad publicity? azcentral chloroform, and the science of medicine: a life of john snow critical race theory, race equity, and public health: toward antiracism praxis key: cord- -eoqpfa k authors: sonenthal, paul d; masiye, jones; kasomekera, noel; marsh, regan h; wroe, emily b; scott, kirstin w; li, ruoran; murray, megan b; bukhman, alice; connolly, emilia; minyaliwa, tadala; katete, martha; banda, grace; nyirenda, mulinda; rouhani, shada a title: covid- preparedness in malawi: a national facility-based critical care assessment date: - - journal: lancet glob health doi: . /s - x( ) - sha: doc_id: cord_uid: eoqpfa k nan covid- preparedness in malawi: a national facility-based critical care assessment has emerged in countries in the who african region as of may , . to treat patients with the disease, facilities require oxygen, intensive care unit (icu) beds, ventilators, isolation space, and personal protective equipment (ppe) among other resources. even in well-resourced countries, covid- has strained or overwhelmed health systems, necessitating surges in icu capacity to accommodate the increased number of patients who are critically ill. assessing readiness of health facilities is a key element of outbreak preparedness, and initial capacity assessments are central to who guidelines for country-level response to covid- . although concerns about the vulnerability of lowincome countries' health systems are widespread, few facility-level assessments of critical care capacity exist in these settings. this lack of data is a substantial barrier to covid- preparedness. malawi, is a low-income country of over million people with reported cases of severe acute respiratory syndrome coronavirus (sars-cov- ) infection and three deaths as of may , . in january and february, , the malawi emergency and critical care (mecc) survey assessed public hospital capacity at all four central (tertiary) hospitals in malawi and a simple random sample of nine of the country's district (secondary) hospitals. here, we present data from the mecc survey relevant to covid- preparedness. the mecc survey combined the who hospital emergency unit assessment tool with additional questions on emergency and critical care capacity in hospitals in low-income countries. newly developed questions were piloted and refined with expert review before inclusion (appendix p ). the final instrument included questions for hospital administrators; clinicians in the emergency department or, if there was no emergency department, the outpatient department; clinicians in the internal medicine ward; and clinicians in the icu or high-dependency unit, if present. clinician surveys for each ward were similar but were adjusted on the basis of the anticipated care activities at each location. at hospitals without an emergency department, the outpatient department was substituted as the most likely site to receive new patients. the sample size of nine district hospitals was determined as part of the broader mecc survey, using methods recommended by the who service availability and readiness assessment. eligible participants had to be aged years or older, a staff member who had been working at the selected hospital for at least month, and self-reported spending at least part of their time working in the hospital area corresponding to the survey section (ie, emergency department or outpatient department, general isolation room ( %)* pulse oximetry (continuous or intermittent) data are n (%). number of facilities reporting adequate access to each item needed for the sars-cov- response. facility-level data reflect average responses from individual respondents within each unit. questions were not asked about access to sars-cov- testing because the survey was developed before the start of the pandemic. for oxygen, invasive mechanical ventilation, handwashing facilities, and isolations rooms, there was "adequately availability" at an area of the hospital if the average score was more than · (out of ). for the remaining yes or no questions, a unit was considered to have access to an individual item if at least two staff members reported availability. ppe=personal protective equipment. sars-cov- =severe acute respiratory syndrome coronavirus . *data missing for this question from one respondent at one hospital. these results should be interpreted in the context of the study design. as a single-country analysis, the generalisability of our findings to other low-income countries is unknown, but similar gaps probably exist in other countries with substantial resource-constraints. furthermore, our sample size was determined as part of a larger study; however, even if not generalisable across the entire health system, the reported gaps are still of importance. our instrument was not specifically designed to assess covid- preparedness because the pandemic had not begun when the study was designed, but survey administration coincided with the beginning of the outbreak. finally, although we interviewed multiple participants on each ward to improve the accuracy of our estimates, some reporting bias might exist (eg, social desirability), which could result in overestimation of resource availability. these findings provide unique facility-based data characterising of available resources necessary for covid- preparedness in an low-income countries. our results highlight the urgent need for shortterm interventions against the current outbreak in malawi. in the longterm, health system strengthening is needed to ensure the capacity of low-income countries to mitigate the effects of future pandemics. we declare no competing interests. pds and jm are joint first authors. mn and sar are joint senior authors. pds received funding support for this study from the division of pulmonary and critical, care medicine at brigham and women's hospital. sar received an esther b kahn seed grant from the department of emergency medicine at brigham and women's hospital. the funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report. we thank joia mukherjee for her advice and support, neill adhikari and the certain study group for permitting us to use their survey validation tool during the piloting our instrument, tim baker for his feedback during the development of our survey instrument, and the ministry of health and population of the republic of malawi for their support and dedication to these important topics. we thank the staff at abwenzi pa za umoyo/ partners in health for their support of survey implementation. icu (table), with a mean of · (sd · ) beds per unit. all four central hospitals, but none of the nine district hospitals, could give non-invasive ventilation and mechanical ventilation. there were working ventilators across all four central hospitals. oxygen was reported as adequately available in five ( %) of outpatient or emergency departments, ten ( %) of general medical wards, and seven ( %) of eight icu or high-dependency units (table) . regarding ppe, all units reported adequate availability of gloves but not eye protection or n masks. isolation rooms were available in seven ( %) medical wards but only one ( %) outpatient or emergency department, and none of the icus or high-dependency units. three ( %) medical wards, six ( %) outpatient or emergency departments, and six ( %) icus or high-dependency units had adequate access to handwashing facilities. using data collected during the first months of the covid- pandemic, this analysis shows crucial gaps in resources needed to treat patients with sars-cov- infection in malawi. expanding and strengthening health system capacity must be prioritised to address this need. the restricted availability of oxygen in medical wards is a particular cause for concern and will result in avoidable mortality in the event of a widespread outbreak. the lack of ppe poses a substantial risk to health-care workers and must also be addressed. globally, thousands of health-care workers have already been infected with sars-cov- and many have died. finally, our findings highlight the crucial importance of early containment in malawi and other low-income countries through widespread testing, outpatient treatment, contact tracing, isolation, and physical distancing. these efforts must be multisectoral and tailored to the local context. effective isolation and quarantine will probably require additional social supports, such as food and water distribution. medical ward, high-dependency unit or icu, or administration). answers were recorded from three staff members at each targeted area in the hospital to allow for addressing discrepancies between participants' responses by averaging answers. all participants provided written informed consent. ethics approval was obtained from the partners institutional review board ( p ) and malawi's national health science research committee (protocol # / / , approval number: ). the malawi ministry of health also approved the study. all hospitals were contacted by study staff in advance of the study team visit and granted approval for study participation through district-level research committees. for the current analysis, we examined questions relevant to treatment of patients with sars-cov- . for questions on oxygen, non-invasive and invasive mechanical ventilation, handwashing facilities, arterial blood gas capabilities, chest x-ray, ultrasound, and isolation rooms, partici pants ranked availability on a scale of to , with indicating generally unavailable, indicating some availability, and indicat ing adequate availability, using definitions established by the who hospital emergency unit assessment tool. the responses from the three participants from each hospital area were averaged to create a final ward score at a given facility. study data were collected using redcap electronic data capture tools then analysed in stata (version ). we interviewed clinical staff (appendix p ) and administrators to develop capacity estimates for units across hospitals. the median population in a hospital catchment area was (iqr - ). among the hospitals with available data, the median number of inpatient beds was ( - ). of the hospitals surveyed, three had an icu, three had a high-dependency unit, and one had both a high-dependency unit and an geneva: world health organization sara): an annual monitoring system for service delivery. reference manual version . . geneva: world health organization research electronic data capture (redcap)-a metadata-driven methodology and workflow process for providing translational research informatics support covid- : protecting health-care workers who. situation report - coronavirus disease clinical management of severe acute respiratory infection when covid- disease is suspected. geneva: world health organization critical care utilization for the covid- outbreak in lombardy, italy: early experience and forecast during an emergency response geneva: world health organization covid- : too little, too late? intensive care unit capacity in low-income countries: a systematic review key: cord- -r td i authors: meessen, bruno title: health system governance: welcoming the reboot date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: r td i nan though a rather recent concept, governance is as old as humanity. over the last two decades, governance has received a lot of attention from the global health community. the governance lens has been applied to, among others, health, health systems, health system strengthening, health system resilience, primary healthcare and hospitals. substantial knowledge and understanding have been accumulated in the process. yet, recent reviews of frameworks have also reported a certain conceptual confusion and lack of progress with the empirical agenda. no framework has managed to impose itself so far. is the health system governance research programme experiencing a stalemate? we don't think so. recent contributions indicate that a conceptual reboot is on its way. a number of researchers are moving away from the government-centred perspective to an understanding of governance as the organisation by human beings of their collective action. the main goal of this paper is to make the case for this extended approach to governance and to explore its implications, both for research and action. the first section consists in a quick summary on the emergence and development of the concept of health system governance. in the second section, a formalised expression of the new approach to governance is sketched; at its centre is the choice set of actions available to groups of individuals. we use the covid- pandemic, one of the biggest collective action problems faced in the history of humanity, to illustrate our point. in the third section, we explore some key benefits attached to the collective agency approach. the paper ends with some suggestions of ways to move forward. in the field of international development, the mainstream view that governance is a determinant of development outcomes follows decades of work developed by the world bank. two who reports have been pivotal in establishing a similar view for health systems: the world health report and, years later, the report entitled 'everybody's business: strengthening health systems to improve health outcomes'. the core contribution of the world health report was to put forward a proposition on how performance of health systems should be conceptualised and measured. its definition of health system performance focused on outcomes which can be attributed to health interventions. the report also looked at determinants of performance. a whole chapter was dedicated to the concept of stewardship, understood as the central responsibility of the government for the overall performance of a country's health system. ► the literature on health system governance is growing. alternative frameworks have been proposed, but none has really imposed itself so far. the empirical agenda is progressing slowly. ► there is a turning point among recent publications: a move away from a government-centred perspective of governance to a broader understanding of governance as the people's organisation of their collective action. ► in this paper, we argue that what matters is the choice set of actions that groups of individuals can undertake, that is, their collective agency. ► the focus on collective agency broadens the perspective for action: the governance of the health system is not only about the ministry of health doing well certain things, it is about groups of individuals being able to organise their collective action, through the state, but also through other mechanisms. ► the collective agency approach opens avenues for research. for example, governance is both an explanatory and an outcome variable. a governance intervention (explanatory variable) may be effective to improve some health outcomes, but also disempower collective action for some groups of the population (outcome variable). by the publication of the report, the concept of stewardship had evolved to 'governance and leadership'. the term 'governance' better captures the fact that health systems are increasingly complex and that in its steering of the health system, a ministry of health has to coordinate with a large set of actors and also to be accountable. the very title of the report acknowledges that health systems are fundamentally collective action problems. however, in subsequent who documents, the distinction between governance and leadership was dropped and many contributors to the field fell back on a ministry of health-centred understanding of governance (see reference ) . the biggest challenge with governance as a concept is probably that it seems to elude measurement. the dominant approach to solve this problem has been to mimic the world bank's approach of state governance and define dimensions. this has led to a proliferation of frameworks. in a report for the european health system observatory in which they compared existing 'frameworks', greer et al concluded that such frameworks were long, normative and arbitrary lists of dimensions or items, and noted that the power of these frameworks to help improve policies still had to be demonstrated. indeed, most have limited empirical validation. this highlights the main limitation with the 'good governance' approach: normative choices (defining how things should be) take a central role in determining both the empirical and the policy agenda. normative orientations are probably inevitable in this field, the problem is that they are rarely cast with sufficient exposure of the values and interests underlying them. this exposes formalisation and subsequent empirical research to arbitrariness or even bias, as authors may be promoting their view of the world or the one that legitimates the theory of change implemented by their agency. because of their constituencies, agencies may be tempted to promote specific governance mechanisms or downplay dimensions that may arouse hostility from some policy actors. recently, several authors have tried to lay down firmer foundations to the governance agenda. for siddiqi et al, 'governance comprises the complex mechanisms, processes and institutions through which citizens and groups articulate their interests, mediate their differences and exercise their legal rights and obligations'. in , abimbola et al explored the lessons from the common-pool resources literature to enlighten collective action for primary healthcare. to our knowledge, this was the first time that the health system governance literature was connecting with the pioneering work of elinor ostrom. if anyone has studied collective action and reflected on how to move from a positivist programme to more prescriptive messages, it is ostrom. in , in a review of the literature, abimbola et al pointed to the shortcomings of the government-centred approach and made the point for a more comprehensive approach to governance and its underlying institutional arrangements. the same year, fryatt et al also came with a more comprehensive approach of governance -it is also marked by their adoption of a non-normative definition of governance-'how societies make and implement collective decisions'. the same year, pyone et al took a similar approach: 'governance is defined as the rules (both formal and informal) for collective action and decision making in a system with diverse players and organisations while no formal control mechanism can dictate the relationship among those players and organisations. adopting such broad and less normative definitions reduces the risk of excluding certain variables from the scope of analysis. with this new view, governance can be summarised as the organisation by human beings of their collective action. we characterise it as a 'reboot' because the focus of the health system governance agenda shifts from the government to the people. governance of the health system is not just about the ministry of health doing certain things well, it is not even about the ministry of health collaborating with other actors, it is about groups of individuals being able to organise their collective action, also through the state, but not exclusively. in the next section, we propose a formalisation of this new perspective. by adopting the extended formulation of governance, we de facto lose our analytical 'anchor': the organisation. as far as health systems are concerned, no longer can our thinking and analysis be organised around the coordination functions played by the ministry of health. what would then be the new variables of interest? our proposition is to organise the analysis around four main sets of variables: ( ) the set of collective action problems to solve (let us call it p) ( ) the group of individuals facing this p (g),( ) the set of possible actions (a) that members of g can take at a time t in order to handle p and ( ) the conditions (c) determining the choice set a. a collective action problem can be defined as any problem whose solution requires some coordination between potentially benefiting individuals. it can be of various natures: a pandemic to contain, child mortality and the need to reduce it, the performance of a specific hospital. g can be any grouping of persons of relevance: investors, local community, the medical profession, a nation, the world population. for sure, it is not limited to civil servants working for the ministry of health. p and g are closely linked. the staff of a hospital (g) will be busy with solving a large set of problems: availability of services, organisation of work, quality of care, management of interpersonal conflicts. many collective action problems require coordination at the level of different gs. as a pandemic, covid- requires action at the global level (eg, under the leadership of who, the international monetary fund, etc), bmj global health but also at the national and community levels. obviously, a multitude of gs creates coordination issues: different groups have diverse interests and sometimes conflicting interests (cf. siddiqi et al's definition). governance is a lot about overcoming such tensions, including, but not exclusively, through mechanisms such as governments. we propose to put the collective agency held by the group, the choice set a, at the centre of the analysis. it can include actions of very different natures. some actions are generic (eg, stating the problem, agreeing on common goals, adopting rules), others are specific to the problem. covid- can be addressed by closing borders, testing, restricting movement, forbidding social gatherings, treatment. an action belongs to a if it is really feasible by g. the set of possible actions a is itself determined by a set of conditions (c): the size and composition of g, the nature, quantity and distribution of resources (including information and trust) endowed by its members, their preferences, organisations (eg, the ministry of health) and other institutional arrangements in place, as well as external factors such as available technology or security. we do not doubt that future work will generate a more granular view of these conditions and their inter-relationships. adopting a collective agency approach to governance has benefits on at least three levels. it creates space for theoretical and empirical research independent from normative preferences. it allows ( ) description of the different sets of interest (p, g, c, a) at different periods of time; ( ) the study of how sets and variables related to each other; ( ) the study of how sets and variables are determined across time (historical studies, path dependency); ( ) the linking of all these variables to other variables of interest. all these aspects can be investigated, in a neutral manner, without some prejudices on some standards of 'good governance'. this opens new territories for health system governance researchers. for example, some researchers may want to study how the actual collective agency of a group is also a result of history. indeed, the capacity of a group to develop health interventions may be partly determined by earlier collective events. good examples of such phenomena are provided by the recent stream of work establishing a link between slave trade or colonial history with trust and capacity to implement collective action in some regions of africa. covid- reveals that this can also play the other way round. in south korea, the painful experience with the middle east respiratory syndromerelated coronavirus outbreak in generated a lot of learning which expanded the set of actions available for the national response to covid- . other analysts may want to reorganise the 'order' of the variables. for the last years, we have looked at governance as a 'building block' contributing to health system performance, the latter being measured in terms of health, responsiveness, financial protection outcomes. by equating governance with collective agency, we can, at last, conceptually handle the fact that our collective agency may also be impacted by health policies-that is, be an outcome variable. with covid- , we have seen how health policies may affect our individual and collective rights. some watchdogs are even worried about long-lasting regressions in terms of civic rights. this new perspective could lead to a better recognition of the contribution of health systems to broader political goals (eg, consolidation of the social contract). by moving the centre of gravity of the analysis (from the ministry of health to our collective agency), the research programme undergoes a double shift which will generate new insights. the first shift is that we now take a neutral approach toward coordination mechanisms. ministries of health, rightly, receive a lot of attention. but let us keep in mind that they are quite modern institutions. our proposition is compatible with the study of institutions organising the practice of medicine in ancient greece or during the islamic golden age, for instance. this is also a reminder that even in our societies, a ministry of health is just one coordination mechanism among others. as stressed by pyone et al's definition, it is the whole nexus of institutions that matters. again, covid- has shown the need to broaden the scope of attention. we have seen how some resources critical for a performing health system (eg, personal protective equipment, test reagents or medicines) are nowadays more governed by global markets than by ministries of health. we have witnessed the spread of conspiracy theories on social media and the subsequent erosion of trust in health authorities. understanding better other coordination mechanisms (eg, social norms, judicial system, the market, social media) seems a prerequisite before calling to an authority for implementing any corrective measure. the second shift is a repositioning of institutional arrangements in the analysis. we do not deny that there is great convenience in anchoring governance analyses on organisations. institutions are key for collective actionthey assign rights and thus reduce uncertainty and coordination costs. as an organisation, a ministry of health constitutes a stable platform. it can issue policies, which are themselves malleable institutions. still, organisations and institutions are just instruments. what ultimately matters to people is the set of actions at their disposal to solve their problems. as analysts we should not forget that this set is determined by more conditions than just institutions. a crucial condition is power. integrating it into the analysis requires going beyond the mere observation that institutions are in place. the right to strike has bmj global health its intrinsic value, but the impact of a strike will depend on how it disrupts the economy and thus empowers the unions in the negotiation. another key factor is trust. low trust in organisations limits options. the covid- crisis has provided examples of nations whose response has been constrained by the growing distrust in the leadership. the collective agency proposition also allows a more opened discussion about what 'good governance' might be. it provides a ranking approach which does not bring straight on the preferences of the authors for, for example, a too specific governance modality. indeed, it gives us probably the least normative ranking criterion possible: for given g and p, it is correct to say that conditions c are superior to conditions c , if a is larger than a . this is not trivial. for instance, from the perspective of a local community (g), a legal system (c ) allowing to set up a community health association is superior to a system (c ) which does not permits that. from the perspective of investors, entrepreneurs or consumers, a social system guaranteeing the rule of law and respect of contracts is also superior to one which does not guarantee such conditions. of course, a choice set a will rarely dominate all the others and more elaborate criteria will be needed to decide on the inescapable trade-offs. this approach will meet its own limitations, but at least, it will lay bare the normative issues encompassed by the health system governance agenda. such an approach valuing 'real rights for collective action' is not without firm moral foundations. it is aligned with the concept of primary goods put forward by rawls or the concept of capabilities developed by nussbaum nd sen. obviously, operationalisation will require to list collective capabilities of importance and establish rules for fair treatment of different groups. we believe this could be done in generic terms (eg, capability for members to appoint a representative to the governing body of the group), but also be tailored to the g, a and p of interest. over these last years, a new view on health system governance has been emerging. a growing number of authors proposed to take collective action as the central issue. we think it is a healthy development, as it will allow to better disentangle the empirical, normative and prescriptive agendas. frameworks and concepts are themselves a source of power and influence; the conceptualisation of governance is, by essence, an area where contributors should be vigilant about their positionality. our message is not that past research and policy guidance should be wiped out. conceptual and empirical efforts dedicated to identifying dimensions of interest (transparency, accountability, etc) and supportive institutional mechanisms remain very valuable. in the end, governments formally take on much of the responsibility for governance; reminding them their duties towards their citizens, especially for 'common goods for health', should remain a central task of multilateral agencies. our point is that this must be embedded in a broader perspective. today, we are far from being conceptually and methodologically equipped to capture the actual rights of the groups of individuals having a stake in health systems. collective agency should be our new conceptual, empirical and prescriptive horizon. we hope that this paper is a useful step in this direction. the collective agency approach to health system governance surely raises its own challenges. its value will depend on how useful it proves when employed in empirical research, reflection and action. it encompasses a risk of misuse, for instance, to legitimate more privatisation, ill-conceived decentralisation, societal fragmentation or the unchecked growth of digital giants. time will tell whether it leads to real progress for people, especially the most vulnerable. at short term, we must be ready to address heads-on some possible tensions, for instance, when a policy is effective to improve some health outcomes but also disempower groups of the population. governance is both an explanatory and an outcome variable for health systems. some of the collective capabilities to protect or to expand may include some sensitive issues (eg, capability to associate or to access reliable information, including through whistle blowers), but there is no escape: excluding them is analytically wrong. we hope that with the collective agency approach, the global health community will manage to get the issue of governance taking off, both as a field of study and an area of intervention. the covid- crisis indicates that it should happen now. governance for health in the st century frameworks to assess health systems governance: a systematic review health governance: principal-agent linkages and health system strengthening governance and capacity to manage resilience of health systems: towards a new conceptual framework towards people-centred health systems: a multi-level framework for analysing primary health care governance in low-and middle-income countries a framework for assessing hospital governance world development report : the state in a changing world health systems: improving performance everybody's business: strengthening health systems to improve health outcomes: who's framework for action monitoring the building blocks of health systems: a handbook of indicators and their measurement strategies a review of health governance: definitions, dimensions and tools to govern framework for assessing governance of the health system in developing countries: gateway to good governance governance: a framework an approach to addressing governance from a health system framework perspective beyond markets and states: polycentric governance of complex economic systems institutional analysis of health system governance health sector governance: should we be investing more? the slave trade and the origins of mistrust in africa violence and indirect rule: evidence from the congo free state national response to covid- in the republic of korea and lessons learned for other countries institutions, institutional change and economic performance economics, organization and management a theory of justice the quality of life measuring governance: accountability, management and research strategies for policy success: achieving 'good' governance financing common goods for health: fundamental for health, the foundation for uhc acknowledgements the paper benefited a lot from the critical comments key: cord- - i nu l authors: o’sullivan, belinda; leader, joelena; couch, danielle; purnell, james title: rural pandemic preparedness: the risk, resilience and response required of primary healthcare date: - - journal: risk manag healthc policy doi: . /rmhp.s sha: doc_id: cord_uid: i nu l pandemic situations present enormous risks to essential rural primary healthcare (phc) teams and the communities they serve. yet, the pandemic policy development for rural contexts remains poorly defined. this article draws on reflections of the rural phc response during the covid- pandemic around three elements: risk, resilience, and response. rural communities have nuanced risks related to their mobility and interaction patterns coupled with heightened population needs, socio-economic disadvantage, and access and health service infrastructure challenges. this requires specific risk assessment and communication which addresses the local context. pandemic resilience relies on qualified and stable phc teams using flexible responses and resources to enable streams of pandemic-related healthcare alongside ongoing primary healthcare. this depends on problem solving within limited resources and using networks and collaborations to enable healthcare for populations spread over large geographic catchments. phc teams must secure systems for patient retrieval and managing equipment and resources including providing for situations where supply chains may fail and staff need rest. response consists of rural phc teams adopting new preventative clinics, screening and ambulatory models to protect health workers from exposure whilst maximizing population screening and continuity of healthcare for vulnerable groups. innovative models that emerge during pandemics, including telehealth clinics, may bear specific evaluation for informing ongoing rural health system capabilities and patient access. it is imperative that mainstream pandemic policies recognize the nuance of rural settings and address resourcing and support strategies to each level of rural risk, resilience, and response for a strong health system ready for surge events. world-wide, primary healthcare (phc) is the foundation of an accessible and costeffective health system. strong phc strongly underpins the achievement of the sustainable development goals, particularly those related to health and equity, in rural communities worldwide. however, when it comes to pandemic responsiveness, including the current global effort against covid- , the nuance of the rural phc pandemic context is somewhat hidden. the focus of clinical interventions has been on urban and metropolitan locations (somewhat driven by the disease infection, severity and mortality rates that may occur in high-density areas). despite this, there is a difference with respect to pandemic planning and action in rural areas. in particular, describing the role and function of rural phc teams in such emergencies has the potential to inform rural health system preparedness to all-nature of hazards of biological, chemical and radio nuclear varieties, whether naturally occurring or not. our aim was to draw on our collective expertise in rural public health, clinical and academic knowledge, to provide a commentary as to our perceptions of the activity and experiences of the rural phc sector during the covid- pandemic. we considered this would be applicable for informing future pandemic policy and planning and ensuring that national responses are tailored to rural contexts. we particularly drew on experiences from canada and australia, as two countries with similar health systems, geography, and rural population distributions. in order to do this, we first discussed the pandemic response we observed in our own country's rural and remote communities to draw out three themes representing interacting phases that were common in both countries: risk, resilience and response. the working definitions for these are summarised in table and explored in the paper as follows. despite the recognition that effective pandemic management requires specific attention to at-risk populations, there is very little literature concerning the nature of risk for rural populations. , although many rural people are affected by covid- around the world, the focus tends to centre on population risk and disease severity in highdensity urban communities. anecdotally, much of the media coverage about case counts and deaths also revolves around urban areas and city hospitals, with limited demarcation of what is going on in rural places. despite this, nearly half the global population lives rurally and has specific risks related to transmissible infections (table ) . many rural communities entered the current pandemic already chronically under-serviced, facing inadequate healthcare infrastructure, limited clinical resources and equipment, and healthcare personnel shortages ( % lacking critical healthcare access). - with respect to their populations, rural communities include more aged, first peoples and socio-economically disadvantaged people, many with higher levels of pre-existing chronic illnesses. some rural and first peoples face extreme socio-cultural barriers related to access to healthcare as well as housing, basic services and digital infrastructure, affecting lower levels of health service access and use relative to their needs. , pre-existing unmet needs may exacerbate pandemic risks unless the healthcare response is adequate, culturally and socially relevant. further, despite the concept that rural communities are safe from pandemic exposures, the high levels of interaction between rural communities, with metropolitan areas and with international communities is an important factor to consider within pandemic policies. some rural communities have strong patterns of using fly-in fly-out workers and short-term rotating locum staff. [ ] [ ] [ ] in australia and canada, around % and % of the rural medical workforce is overseas-trained, many of whom visit their home country and have regular family visiting. , moreover, in rural communities, goods and services are often traded in a relatively informal economy through local entrepreneurship and reciprocity as a vital part of sustainable development. commodities available in one community may not be in another, only reinforcing travel between communities. rural populations may also rely on more multi-site employment (intra-rural and rural to urban) and educational models, including boarding schools, posing other infection risks. , rural locations may also experience significant numbers of people visiting holiday homes (sometimes to get away from pandemics 'hot spots'), as well as mobile tourist groups including many "grey nomads", people who are post-retirement, taking lengthy holidays, some of whom may be trapped in rural locations by border closures during a pandemic. , together, the patterns of rural mobility increase the threat that rural communities will be exposed to infectious diseases, with potentially dire consequences unless specifically acknowledged and managed. with respect to the risk of community transmission, the conditions in rural areas may pose particular challenges. first peoples have high rates of short-term inter and intra community movement patterns within regions (around trips per year, often related to kinship), and are subject to over-crowded housing ( . % of housing considered not adequate for the number of people per dwelling). , mainstream policies to promote or mandate self-isolation during pandemics may be impractical to implement and work against the goal of reducing the rate of infection in rural and remote settings. instead, rural communities may need to identify specific ways to respectfully adjust normal community movement patterns and consider ways to provide safe sheltering options for isolating unwell people. these considerations must address the social, economic, and cultural determinants of health in order to be effective. chronically under-serviced, with higher rates of chronic illness and limited clinical resources and equipment and health personnel. communities of a high fly-in-fly-out workforce over diverse borders, high levels of overseas-trained health workers. inter-community sharing of goods and services. multi-site employment, boarding schools, tourists and particular industries. host of a number of holiday homes and roving tourists. inter-personal interaction between community members and mobility between first peoples visiting family/kin on-country. co-location of hospitals and aged care services. overcrowded personal spaces (housing), make it challenging to isolate unwell people. risk communication challenges, related to lower education levels, different language groups and potential stigma of illness. diverse population with greater access to employment, education and health services. mostly within city population movement, using a higher proportion of locally available healthcare workers. visitors may include more "short-stay" individuals, often related to employment. fewer students leaving home to attend rural boarding schools. large gatherings more common, high-density community and over-crowded communal spaces and office buildings that need to be managed. hospitals, a potential source of exposure. risk communication tailored to more educated population. resilience the potential of the system and population to withstand possible ill-effects from the threat/hazard. within-city networks and transfers rapid. administrative staff capacity sound. policies already tailored to setting so easier to apply. long-term staff and staffing stability. less staff burnout and impact of staff isolation policies as overall numbers of trained health workers and phc teams greater. stockpiles required, but supply chains turn on more rapidly. (continued) perceived and real risks may be exacerbated unless risk communication accounts for the lower education levels of rural populations, different language groups and the potential stigma related to illness in rural and remote communities. failing to do so may also reduce perceived risk and compliance with public health information and negatively impact health service use. , finally, in rural areas, health services may be colocated with other human services, in multipurpose centres, which operate as part of networked and integrated service models that aim to support health and human services for people as close to home as possible. these potentially place long-term aged care residents within proximity of infectious patients, warranting site-specific risk assessment and adjustment. mindful of different risks in rural settings, mainstream policies for health services, border control, population monitoring, self-isolation and closure of essential services require rural tailoring. the mainstream population health and health service resilience to covid- has largely centred on building hubs for testing, upscaling tracing and isolation activity along with building hospital service capacity including equipment and intensive care unit beds. but rural resilience relies on the availability of strong qualified phc teams covering services most relevant to the population's needs. , the focus on strong phc is essential as most rural towns have small (< bed) (minimal high dependency care), or no hospitals and more remote communities rely on community clinics, nursing stations or visiting primary healthcare teams (table ) . [ ] [ ] [ ] [ ] these are connected to a network of rural hospitals some distance away by road or air, demanding rural people undergo significant personal travel or use retrieval services. , when patients need higher-level care elsewhere, this imposes substantial financial, cultural and emotional burden on rural people whereby the phc team aims to optimise prevention and early intervention to mitigate infection and minimise the need for patients to travel. resilience is challenging as many rural phc teams are small and need to sustain a high workload and strong community leadership during a pandemic response. an australian national survey of general practitioners (gps) working during the covid- pandemic identified that gps in rural areas were more likely to maintain or increase patient numbers relative to gps based in urban areas (where patient numbers dropped). this may be because small rural phc teams absorb any pandemic clinical services on top of their normal workload with few buffers from other doctors in town. further, there may be a much higher administrative burden on phc leaders to digest and implement rapidly evolving policies and guidelines. these policies may be inadequately tailored to the rural context. one study identified that guidelines from various official agencies involved in healthcare may be in direct conflict with each other, making it challenging to interpret the correct course of local action needed. a real-time system allowing rural phc staff to pose questions and receive rapid answers (such as the one recently set up by project echo, university of new mexico, usa), may be suitable to use within each nation's pandemic response. potential impacts on the mental health and fatigue levels of phc staff are also probable in rural settings. although there are no rural-specific figures, a national cross-sectional survey of australian doctors during the covid- pandemic identified that . % of gps reported felt "tense, restless, nervous or anxious or unable to sleep at night because his/her mind is troubled all the time" a lot more than usual. some stressors may be concerns about being exposed to infection as a frontline healthcare worker, despite the strength of screening and triaging processes. of all occupations, healthcare practitioners have the highest likelihood of exposure to diseases. other stressors relevant to rural phc teams may relate to any overlapping and conflicting patientprovider relationships they may experience around rising rates of community mental illness, job losses and poverty, domestic violence or crime during pandemic periods. these may have strong effects on rural healthcare workers whose professional lives are intertwined with their personal connections to people in their community. resilience in rural areas strongly depends on local phc teams spending time analysing the strengths and opportunities of their local healthcare networks and patching any gaps. this may require the development of new collaborative frameworks to build resilience in various regions or local populations. to some extent, these depend on the level of pre-existing community trust they have and their relationships with other health services. this is enabled when primary healthcare workers have been working in the same area for some time. however, for many small rural and remote communities, poor stability of the workforce is a threat to resilience. phc staff turnover is more common in more remote locations than in regional and urban centres and there is a stronger reliance on locum or other short-term staff (for example, in australia's remote primary care clinics only % of nurses continue to work in the same remote clinic months after commencing). , in the event of pandemic responses becoming quite protracted, rural resilience may also be threatened by the potential burnout of rural phc workers, a group that already works more hours and has higher turnover than its urban counterparts. burnout threatens rural community health and local health system leadership because of the small number of health workers in rural settings. , surge policies to provide additional staffing to rural phc teams could be activated early in pandemic situations to embed more capacity of "super-numeri" staff within the response, and enable viable rosters for phc workers to get enough rest. this arrangement also serves to allow any exposed/unwell staff to undergo self-isolation, without impacting the rest of the team and the community's access to care. whilst states/provinces and nations clamber to find enough personal protective (ppe) and other infection control equipment during pandemics, this infrastructure becomes increasingly centred on large hospitals and cities facing the most progressive levels of illness. this may leave many rural phc providers unprotected, sometimes with no assurance they will get ppe. the lack of ppe poses a critical threat in rural settings where the pool of available phc workers is precariously small and serves an undifferentiated caseload of infectious and non-infectious people dispersed across large geographic catchments. if sufficient protective equipment cannot be obtained, then rural phc teams strongly depend on non-contact treatment methods and community support for making their own protective gear or using home-grown methods of sterilizing. ideally, some assurance by government that sufficient baseline supplies and any scaled up resources will be provided where needed, would buffer the resilience of individual phc units. in the same vein, an additional resilience factor for rural communities is having access to adequate clinical testing capabilities and relevant treatments. a study of the perspectives of first nations peoples about the influenza pandemic identified that "supplies" (ordering, maintaining and providing pandemic supplies) were a key "overlooked" aspect of existing pandemic plans. finally, rural resilience depends on phc teams and the community having specific advice about sensible systems for patient retrieval for higher level care. phc teams are well placed to understand the best pathways for patient transfer but this may require government support for negotiating the guarantee of transport and higher-level services accepting unwell rural patients. feeling resilient depends on knowing that this plan will allow for situations where the local caseload may rapidly rise. such continuity business planning has been described as essential in other pandemics. meanwhile, other research has identified that those communities with rural hospitals, should bolster their capabilities to manage infected individuals for interim periods, where transferring acutely unwell patients to larger centres is not feasible, nor immediate enough. the healthcare response to covid- has anecdotally been portrayed in the media as hospital care. however, in rural areas, the response phase related to phc teams introducing of a differentiated range of treatment services for infectious and non-infectious members of the community as well as adopting new preventative clinics that are readily accessible by rural populations (table ) . this often involves delivery of more ambulatory clinical services, including new in-and out-of-clinic services, collaborating with community public health services and introducing innovative triaging and testing systems for unwell people. unlike urban models which are fixed, rural phc services are highly needs-based and flexible and this is exacerbated in line with emerging pandemic and local conditions. other than treating regular clients and managing potentially infectious patients, new or revamped preventative clinics may be needed, including targeted vaccination clinics, prescription services by phone and advanced care planning. these serve to better position the community and free up the available primary resources for responding to new infectious cases. there is some potential that these add to the service loads of rural phc teams, and this should be explored and linked to the notion of workforce surge needs. historically, many governments have restricted funding for telehealth to non-primary care doctors, such as referred specialist medical services which are the least accessible medical service in rural areas. however, new government policies during the covid- pandemic in australia and canada started to fund rural phc teams to use telephone and video consultations. this funding is in recognition of the role that telehealth plays in phc in non-contact healthcare for protecting health workers and the community from infection. in rural settings, it has also provided a potential option to surge rural workers to overcome staff shortages, staff isolation (due to exposure) and border closures. telehealth availability, funded in phone and video formats, has provided for unprecedented capacity to grow and diversify models of phc services fit for rural communities, using a wider choice of platforms of choice. further, the flexibility to deliver services via video-or -phone assists to deliver consultations through a simple base of interaction where this is a better fit. as a model, telehealth, and the blend of phone and video used, still requires evaluation within the rural context to establish where it offers the most utility for providers and patients. this is because its long-term use may require a significant change in management effort and the redesign of existing models of care. it is imperative that such models do not add excessive demand for mobile technology and at-home medical devices that rural and remote people and rural phc teams may find hard to access. more work is needed to determine the proportion and nature of phc services that fit telehealth delivery and how these are optimally complemented with in-person consultations. rural phc teams and rural health services researchers are possibly best placed to explore this topic given they have the most in-depth knowledge of the dynamic and complex environment of rural and remote settings. in the rural system, the capacity to overlay telehealth largely depends on the stability of a trained phc workforce in rural areas, their equipment and adequate broadband internet services. one national cross-sectional survey during covid- identified that gps in the most disadvantaged areas, and gps in rural areas used less telehealth. this perhaps reiterates the imperative of understanding the context of use in rural areas. like in urban areas, telehealth is a potential adjunct service in rural areas. but it may have less capacity or more dire consequences if replacing face-to-face services for disadvantaged and socially isolated groups in the community. this is because in rural settings, there are likely to be differences in the patient's approachability and acceptability of online health services including for aged, disadvantaged, culturally diverse and first peoples and seeing the doctor may provide better quality of care and social contact (and therefore health benefit). the potential for digital inequalities (at the supply and demand side) is an important issue for rural communities to adopt technology-based healthcare solutions. many rural places continue to lack stable internet service networks, particularly when more people may be working or self-isolating at home during pandemic periods. a high proportion of rural areas may experience broadband connectivity issues resulting in weak or no access to the internet meaning that phone-calls remain a central back up system. , further, some rural communities may incur high costs associated with high-speed broadband internet use as another limitation. in conclusion, the specific needs of rural communities may inadvertently be overlooked within rapid mainstream pandemic planning. however, these communities have widely different contexts from urban settings. this commentary highlights that specific preparation is needed for addressing nuanced rural risks, building community resilience, and fostering a coordinated and supported rural phc response. critically pandemics present an enormous risk to a small critical mass of rural phc teams, and the communities they serve. this is particularly in relation to their smaller staffing and infrastructure, serving a diverse population with higher pre-existing healthcare needs. this perspective identifies clear opportunities to continue to future-proof rural phc systems for surge events. this article did not require ethical review as it used available published literature. the authors report no conflicts of interest for this work. risk management and healthcare policy is an international, peerreviewed, open access journal focusing on all aspects of public health, policy, and preventative measures to promote good health and improve morbidity and mortality in the population. the journal welcomes submitted papers covering original research, basic science, clinical & epidemiological studies, reviews and evaluations, guidelines, expert opinion and commentary, case reports and extended reports. the manuscript management system is completely online and includes a very quick and fair peer-review system, which is all easy to use. visit http://www.dovepress.com/testimonials.php to read real quotes from published authors. contribution of primary care to health systems and health. millbank quarterly sustainable development goals redesign of a rural emergency department to prepare for the covid- pandemic world health organization. rapid risk assessment of acute public health events australia's influenza pandemic preparedness plans: an analysis united nations department of economic and social affairs population division. the world's cities in -data booklet global evidence on inequities in rural health protection: new data on rural deficits in health coverage for countries australian institute of health and welfare. rural and remote health experiences of 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creates culturally appropriate and community informed pandemic plans after the h n influenza pandemic: remote and isolated first nations communities of sub-arctic ontario pandemic influenza and critical infrastructure dependencies: possible impact on hospitals primary care integration in rural areas: a community-focused approach enhancing chemotherapy capabilities in rural hospitals: implementation of a telechemotherapy model (qrecs) in north queensland, australia telehealth for global emergencies: implications for coronavirus disease (covid- ) patient-centred access to health care: conceptualising access at the interface of health systems and populations digital inequalities in rural australia: a double jeopardy of remoteness and social exclusion digital divides and the 'first mile': framing first nations broadband development in canada a jurisdictional scan of the programs and services available to support the community reintegration of ircs youth in northern saskatchewan. saskatoon: university of saskatchewan centre for forensic behavoural science and justice studies key: cord- -rp eoonp authors: bdaiwi, yamama; rayes, diana; sabouni, ammar; murad, lina; fouad, fouad; zakaria, waseem; hariri, mahmoud; ekzayez, abdelkarim; tarakji, ahmad; abbara, aula title: challenges of providing healthcare worker education and training in protracted conflict: a focus on non-government controlled areas in north west syria date: - - journal: confl health doi: . /s - - - sha: doc_id: cord_uid: rp eoonp without healthcare workers (hcws), health and humanitarian provision in syria cannot be sustained either now or in the post-conflict phase. the protracted conflict has led to the exodus of more than % of the healthcare workforce. those remaining work in dangerous conditions with insufficient resources and a healthcare system that has been decimated by protracted conflict. for many hcws, particularly those in non-government-controlled areas (ngcas) of syria, undergraduate education and postgraduate training has been interrupted with few opportunities to continue. in this manuscript, we explore initiatives present in north west syria at both undergraduate and postgraduate level for physician and non-physician hcws. conclusion: challenges to hcw education in north west syria can be broadly divided into . organisational (local healthcare leadership and governance, coordination and collaboration between stakeholders, competition between stakeholders and insufficient funding.) . programmatic (lack of accreditation or recognition of qualifications, insufficient physical space for teaching, exodus of faculty affecting teaching and training, prioritisation of physicians over non-physicians, informally trained healthcare workers.) . healthcare system related (politicisation of healthcare system, changing healthcare needs of the population, ongoing attacks on healthcare.) locally implementable strategies including dedicated funding are key to supporting retention of hcws and return during post-conflict reconstruction. health workforce planning during conflict and in the post-conflict phase is essential to ensuring sufficient supply of healthcare workers (hcws) of the right cadres and skills to meet the needs of the healthcare system [ ] . the education and training of hcws is fundamental to this however it is often neglected or adversely affected by political instability and conflict, particularly those which are complex and protracted such as in syria. syria's conflict began with peaceful uprisings in march but by mid- escalated into a conflict which has devastated its health system and eroded its healthcare workforce [ ] . as of april , more than healthcare workers (hcws) have been killed (mostly by the government of syria and its allies) and more than % of hcws have been forced to flee due to violence [ ] [ ] [ ] . this has left those who remain working in an understaffed and underfunded healthcare system which is increasingly fragmented and politicised due to the prolonged conflict. the insufficient numbers of senior faculty has affected training, leadership and governance [ , ] leaving undergraduates and junior postgraduate staff with inadequate training or mentorship and under conditions which require them to work beyond their training or expertise [ , ] . the political complexities and ongoing violence with the competing needs of health and humanitarian priorities has also affected healthcare workforce planning with potential consequences during post-conflict reconstruction [ ] . healthcare needs of the population increase and change during protracted conflict due to violence, interruption of vaccination campaigns, effects on essential services and poor access to healthcare [ ] . this occurs alongside the negative effects on the education and training of hcws which affect the quantity, skills, distribution and quality of hcws who enter the workforce [ , ] . in syria, the conflict has exacerbated existing preconflict geographical inequalities in healthcare access; aleppo, homs, idlib, dera'a, rural damascus and deir ez-zor have the lowest numbers of doctors per population [ ] . poor healthcare planning and ongoing violence have led to uncontrolled and largely unregulated expansion of private providers contributing to poorly planned, uneven distribution of health and medical services among geographical regions [ ] . a population based survey that was performed in government and nongovernment controlled areas by the syrian centre for policy research noted that % of the population lived in areas where hcws were insufficient and % live in areas where hcws are completely absent [ ] . there are no accurate estimates of the number, distribution and specialities of syrian hcws who remain in syria and population mobility is such that estimates are quickly out of date. in , the world bank estimated the number of doctors per population in syria to be . with a significant decrease from when it was . [ ] . for nurses and midwives, the estimated decrease between and is from . to . per population [ ] . in north west syria, an area which has seen large scale population movements and increasing violence has an upper estimate of doctors ( are hospitalists) for its . million population; there are up to midwives, nurses and community health workers [ ] . it is important to note, however, that these estimates may be an overrepresentation of actual hcws that exist given the lack of official registration and risk of double-counting hcws who work in multiple facilities. healthcare workforce management in syria is challenged by the fragmented healthcare system which has different health and political leadership across the country [ , ] . broadly, this includes areas under government control, north east syria (under de facto kurdish control), north west syria (under opposition control) and areas in northern syria which are under turkish control [ ] . this affects national as well as regional healthcare workforce planning and affects the education and training of undergraduate hcws across the country but particularly those in areas outside of government control with some students who oppose the government in these areas intimidated or arrested [ , ] . areas outside of government control are also affected by an absence of universities whose degrees are accredited or recognised by international bodies [ ] . due to particular challenges arising in north west syria with regards to the healthcare system, healthcare workforce and the potential to highlight illustrative factors relevant to hcw education and training during conflict, we have focused on this area [ ] . during the course of the conflict, this area has developed a complex healthcare system where syrian-led initiatives, syrian nongovernmental organisations (ngos,) international ngos and international organisations (e.g. who, un) have provided cross-border health and humanitarian care; this has been mostly coordinated through the who-led health cluster in gaziantep, turkey [ ] . some of these organisations have also provided education or training to support the healthcare workforce on whom they draw on for staffing projects and healthcare facilities in north west syria [ ] . as of may , it describes an area which includes idlib, north west hama, northern aleppo and north eastern lattakia governorates [ ] . this area has seen a further escalation of violence in february and then again between december and march when almost million civilians were forcibly displaced from their homes, including many hcws [ ] . access to undergraduate hcw education and postgraduate training differs across geographical parts of syria, particularly given the varying effects of the conflict across the country, the presence of an academic workforce, governing bodies, opportunities for continued training, accreditation, leadership, and specialization. data from inside syria is sparse as the situation has been rapidly changing with limited information about what undergraduate education or postgraduate training is available to hcws in different areas in syria. this is particularly the case for areas outside of government control, where volatile conditions and poor access for humanitarian agencies and researchers limits the ability to gather reliable, real-time information [ ] . therefore, in this manuscript, we explore current initiatives present in the north west of syria at both the undergraduate and postgraduate level for physician and non-physician hcws and the challenges faced in providing undergraduate education and postgraduate training during the conflict. this is with the aim of exploring the current provisions of hcw education and training and providing some comparisons to other conflict or postconflict settings. we conducted a desk-based literature review of available academic and grey literature which explore the undergraduate education and postgraduate training of healthcare workers including both formal and informal initiatives. we searched the websites of ngos (non-governmental organisations) which are known to provide education opportunities to hcws. we supplemented this with brief interviews to solicit clarifications from relevant stakeholders based within syria and neighbouring countries to ensure that available material was up to date and to supplement what was found through the literature search. we also used notes from a meeting in gaziantep where syrian and international ngos met to discuss hcw education in the summer of . the interviews were not conducted as a formal qualitative research study; as such ethics review was not indicated. for the purposes of this manuscript, the term nonphysician hcws is used to describe allied health professionals including physiotherapists, nurses, specialist nurses (e.g. neonatal, dialysis,) pharmacists, midwives, dentists, paramedics and emergency or anaesthetic technicians; the term physician hcw refers to doctors. we have used 'education' to refer to undergraduate education and 'training' to refer to postgraduate or speciality training for both physician and non-physician hcws. the activities of the main public sector, private sector, ngos and international organisations which support undergraduate and postgraduate hcw education and training are summarised in table . before the conflict, syria had five public universities with faculties of medicine: damascus university, university of aleppo, al-baath university (homs), al-furat university (deir ez-zor), and tishreen university (latakia) [ ] . (see fig. ) studies were delivered in arabic. the structure of courses include basic medical sciences during the first years with clinical modules in years and and clinical rotations in year [ ] . aleppo university was the main university in the north west and was the second largest university in syria. it had a number of faculties including medicine, pharmacy, dentistry and nursing. the university ran six hospitals in aleppo including aleppo university hospital, aleppo university cardiovascular surgical centre, surgical ambulance hospital, obstetrics and gynaecology hospital, oral and maxillofacial surgical centre and al-kindi hospital. universities and undergraduate students have not been spared the effects of the conflict. the university of aleppo was bombed on th january , killing people including students in an aerial attack [ ] . al-kindi university hospital (affiliated to aleppo university) was destroyed by bombing [ ] . the increased security threats, including bombardments, detention and torture, pushed many students to give up their studies and flee either out of the country or to ngcas. some of the most affected were those near the end of their degrees with little option to transfer to other universities inside syria given security concerns including the risk of arrest by the gos if they were thought to oppose the government or to have studied at 'opposition institutions.' [ , ] for students and academic staff who remained in the ngcas, some were able to continue their studies/lecturing in underground classrooms but others had to suspend their studies/academic career and contribute to humanitarian and healthcare provision to civilians affected by the conflict [ , ] . some were killed either during attacks on universities or during the course of the war [ ] . as a result of the protracted conflict, targeting of healthcare and demand for trained hcws in north west syria, new faculties and institutes have been established in attempts to meet the education and training needs of physician and non-physician hcws. established facilities include three public faculties of medicine and three faculties of pharmacy at the free aleppo university (fau), idlib university and shahba university; the latter was established in dana to cover areas that are geographically far from idlib university's main campuses. there are six newly established healthcare institutes, three of which are still operating as of october (termanin institute, the medical sciences academy in qah, and idlib university institute) covering nursing and midwifery training, and three had been closed after repeated attacks (kafr sijneh institute, birnas institute, and maarat alnuman institute). (personal communication) none currently have official recognition or accreditation for their degrees. the demand from potential students and from potential employers has resulted in an economy around hcw education. this led to the founding of two private universities in north west syria: ebla university which was operating until but closed after repeated attacks and the north syria private university which is still operating. other private universities provide health-related degrees and established either before or after the conflict; some have continued to function while others have closes as they struggled to meet required standards set [ ] . in this section, we discuss public universities, private universities and ngo-led undergraduate initiatives available in north west syria in more detail. the main public universities in the north west are the fau and the university of idlib. the fau was founded as an alternative to universities in gcas in december by the ministry of higher education of the syrian interim government and has since been contested in northeast idlib by the rival opposition government, the syrian salvation government [ , ] . they provide degrees in a number of subjects including medicine, engineering and mathematics, however, there is no formal recognition or accreditation for these outside of ngcas [ ] . it is estimated that there are students in the / academic year, enrolled with campuses across the ngcas. in the / academic year, a second public university called shabha university (previously known as nahda university) was established; it is associated with the higher education council and has been established in buildings that previously belonged to the fau. it is in al-dana and has branches in sarmada and atareb [ ] . the university of idlib is associated with the syrian salvation government and was formed in late [ ] . it uses the infrastructure and the buildings which previously belonged to the idlib campus of the university of aleppo. it currently has , students across faculties including faculties of medicine and dentistry; numbers increase to , students once the medical and dental students in maarat al-numan are included [ ] . the faculty of medicine is listed in the world directory of medical education however it has yet to receive international recognition [ ] . the war has contributed to the necessity for and a trade in the provision of private healthcare education and training in north west syria. however, these are often poorly regulated with little standardization or governance and have been more challenging for the local health directorates to regulate. they charge approximately usd per year and some provide options for distance-learning in addition to on-campus training. examples of some of these universities include: al-shamal private university which was set up with the merger of 'oxford university of syria' and the university of rumah; the 'oxford university of syria' was opened as a branch of the yemeni oxford university which is recognised by the yemeni ministry of education and the arab league [ ] . other private universities include mari university (established in in mersin;) osmania university (established in istanbul in , is a branch of the university of malaysia, and has recognition in yemen;) al-hayat university of medical sciences (established in maarat al-numaan in with disciplines in nursing, midwifery, physiotherapy and anaesthesiology.) [ ] some of these universities faced internal administrative, financial and governance challenges which affected their credibility and caused some to close. in addition, the syrian salvation government has tried to enforce registration, permits and affiliation with it driving some private universities to close their doors [ ] . iii. non-governmental organisation led undergraduate initiatives due to insufficient supply of hcws and increased demand as well as the recognised need to fill the gaps left by public and private universities, some diaspora ngos, often in conjunction with international organisations or universities have set up both undergraduate and postgraduate training initiatives to bridge gaps. these include undergraduate and postgraduate training, short courses, cme (continuous medical education), skillsbased training and is aimed at physician and nonphysician hcws. many educational and training opportunities have been created in response to the operational needs of the ngos as well as the health and humanitarian needs of the population. though ngos have provided in-service training in other conflict or postconflict settings [ ] the extent to which this has been required to meet the needs in north west syria has been more extensive and more sustained. some international ngos e.g. medecins sans frontieres have recognised the need for structured training for its local hcws and have set up an academy for healthcare in to support hcws in areas where they work [ ] . a full review of the courses provided by ngos is beyond the scope of this article, however some examples are given here. the syrian american medical society (sams,) a us-registered humanitarian organisation, continues to support two training programs for midwives at al salam obstetric centre in idlib. one is a -year training program where undergraduate enrolment occurs after high school and the other is an -month conversion course taken by qualified postgraduate nurses; there are currently students in the former who will graduate in february [ ] . they also support nursing education which started as - month courses in idlib, homs and deraa. in , they received funding to develop a two-year undergraduate nursing program in termanin in idlib; there are currently first-and second-year students in general nursing and in public health. in december , students graduated from the sams nursing program [ ] . most recently, a collaboration between sams and the idlib health directorate resulted in the successful examination of student midwives in maarat al-nu'man and omar bin abdul-aziz in termanin [ ] . a uk-registered ngo called hand in hand for aid and development trained healthcare workers (doctors, nurses, nursing assistants, midwives) in as part of their livelihood program [ ] . the syrian expatriate medical association (sema) provides training through its academy of health sciences [ ] ; in , sema trained nurses, paramedics and physiotherapists through year diplomas [ ] . they also provide online lectures for the students. though these initiatives fill an important gap and can be responsive to local needs, the courses provided by ngos are not accredited or recognised outside the area however they do provide students with skills and opportunities to work with ngos in north west syria. these initiatives may be poorly coordinated, donor or ngo driven which could lead to duplication or gaps with little opportunity to standardise or provide quality assurance. this is being addressed by the local health directorates to ensure fair access to potential students and improved coordination. postgraduate speciality training for physicians is provided the ministry of higher education or the ministry of health however, in opposition areas, this would fall under the remit of the local health directorates. to fill this gap, syrian led initiatives have been established. the most prominent of these in north west syria is sboms (syrian board of medical specialties) which was set up mid- with the aim of providing certification for the completion of speciality training after review of applicants' experience and success at standardised examinations. it is affiliated to the ministry of health of syrian interim government (sig) [ ] and works in coordination with health directorates in idlib, aleppo, and hama to expand postgraduate and speciality opportunities for hcws inside syria, based on projected healthcare system needs. sboms was set up as an independent legal and financial identity but is yet to be registered. they have scientific committees (consisting of specialists who remain in syria and expatriate syrian doctors in the diaspora) who provide support for post-graduate training, examination and certification in a number of specialties including internal medicine, general surgery, vascular surgery, paediatric surgery, orthopaedic surgery, urology, paediatrics, cardiothoracic, obstetrics and gynaecology, ent, ophthalmology, anaesthesia and intensive care, maxillofacial surgery, neurosurgery, and psychiatry. though sboms has initially focused on physicians, they plan to expand to non-physician postgraduate training. training is between years (e.g. internal medicine, paediatrics) and years (e.g. neurosurgery). so far, they have supported the training of residents. in , sboms successfully collaborated with the health directorates to support haematology and oncology specialty training for doctors in these governorates [ ] . the need for short updates which are focused on building the capacity of hcws to meet the immediate needs of the population and the ngos' operational strategies has led predominantly syrian ngos to provide short updates for qualified hcws. some have been funded through private funds whereas others have been provided with funding from international ngos or international organisations. most of the training has been delivered by syrian expatriate ngos (predominantly sams, sema, uossm, hihaid, syria relief, syrian relief and development) either in syria (in training centers in idlib or bab al-hawa on the syria-turkey border,) in turkey (in gaziantep, reyhanli or yayladag) or via tele-education. courses provided range between and day updates on particular topics e.g. intensive care, general practice, microbiology, paediatrics to longer postgraduate courses which lead to certification; these include training for midwives, healthcare assistances, nurses, anaesthetic and dialysis technicians [ , ] . other initiatives have utilised expatriate syrian experts or international trainers to deliver sessions or have developed collaborations for tele-education e.g. with yale university, the university of albany in the us, however many of these have not been sustained [ , ] . other providers including who have focused on training syrian hcws in particular topics such as infection prevention and control, post-surgical infections and mental health gap action programme (mhgap) [ ] . unfpa has supported a midwifery capacity building program began started a training-the-trainers program over month periods during and with three sessions in gaziantep and coaching during and after, in addition to certificates issued by unfpa to accredit the trainees to be trainers in syria [ ] . in september , the idlib health directorate celebrated the conclusion of the unfpa reproductive health training program, awarding female reproductive health trainees with certificates indicating the success of their training, supervised by the unfpa and the health cluster [ ] . though numerous training courses for hcws have been held, there has been limited coordination, standardization or quality control for the training provided. idlib health directorate has tried to address this through the appointment of a focal point whose role is to coordinate and prioritize topics for training courses for hcws from idlib and to liaise with providers. (personal communication) training opportunities have also recently been hampered by the escalation of attacks in the north west since february as well as greater difficulties for syrian hcws to obtain turkish permits to cross the syrian-turkish border in order to attend training in southern turkey over the last years [ ] . the opening of training centres in idlib (one in and one in september ) may support further opportunities for the education of hcws however the entry of foreign experts to idlib via turkey will be limited given ongoing security concerns and border closures due to the ongoing covid- pandemic. as such, increasing use of tele-education is being put in place to deliver remote education. in syria, tele-education has been used with mixed success with challenges including logistics and cost, consistent expertise outside of syria, connectivity and, in the case of clinical skills, the benefits that in-person training would provide. blended modes of learning e.g. teleeducation with some in-person training or contact time if possible may be the best approach to ensure relevant theoretical and practical skills are introduced. given current insufficient numbers of educators among the healthcare workforce in north west syria, more efforts to capitalise on available technologies which support the education of hcws is needed. tele-education has been used in other conflict and post-conflict settings including iraq, gaza [ , ] , bosnia and herzegovina [ ] ; some of these have been collaborations with international universities e.g. mayo clinic, queen mary university in london and have usually focused on a single topic e.g. burns care, intensive care education. further work to provide sustained and evaluated courses is needed to meet the training needs of hcws in north west syria. despite the clear need for a skilled workforce of sufficient number and training to meet the current and future demands of north west syria's complex healthcare system, the provision of hcw education and training remains fragmented, politicised and uncoordinated. hcws continue to face numerous obstacles, including ongoing interruptions to education and training, lack of access to advanced specialty training and professional development opportunities of sufficient quality and which are accredited and recognised outside of the area. providing relevant opportunities can improve retention of hcws and may support return of those who have been forced to flee, promoting long-term peacebuilding efforts [ ] . as such, focused and realistic strategies which include key stakeholders and which are led and coordinated by local governing bodies (health directorates) could improve opportunities for hcw education and training in north west syria. this could have positive consequences on the local healthcare system including the retention or return of hcws, and the overall reconstruction of the syrian healthcare system. challenges to hcw education in north west syria can be broadly divided into . organisational (local healthcare leadership and governance, coordination and collaboration between stakeholders, competition between stakeholders and insufficient funding.) . programmatic (lack of accreditation or recognition of qualifications, insufficient physical space for teaching, exodus of faculty affecting teaching and training, prioritisation of physicians over non-physicians, informally trained healthcare workers.) . healthcare system related (politicisation of healthcare system, changing healthcare needs of the population, ongoing attacks on healthcare.) similar challenges have been highlighted in other conflict affected contexts including iraq [ ] and gaza [ ] where politics, economics and inability to recruit educators have been noted. in gaza, an additional challenge highlighted is the disorganised post-graduate programs with limited continuing professional development; this has been cited to be a factor contributing to low morale among doctors [ ] . figure summarises key challenges in north west syria and their relationship to providers and recipients of hcw education. some of the key challenges are explored in more detail below. educational governance in north west syria has been challenging though public institutions and an increasing number of the ngo led initiatives have monitoring and evaluation programs in place [ , ] . however, there remains a lack of oversight or a standardised approach with ngos often answerable to their funders to a greater extent than local governing bodies. for private led initiatives, regulation has proven particularly challenging [ ] . idlib health directorate has led a number of initiatives to address issues surrounding educational governance and have developed a central database of the healthcare workforce including skill-mix and training gaps, coordinated capacity building initiatives across health facilities, identified physical spaces where training can occur and have supported programs which meet the needs of the healthcare workforce. sboms has taken a leading role in postgraduate training and certification (with support from diaspora syrian hcws) to provide standardisation to specialty training; for internal medicine postgraduate specialty training, a diaspora ngo (sams) provided a stipend and training for doctors as a financial incentive to allow them to work and provide much needed healthcare for the local population while training. however, similar initiatives and the work of sboms and the idlib health directorate are met with funding constraints which affect sustainability and planning. the funding shortfall for health and humanitarian provision to north west syria is large with very limited financial resources available for hcw education and training. for example, donor funds have been redirected from local health directorates to the who to implement and oversee hcw educational programs, weakening the role and influence of local health directorates [ ] . this can partly be addressed by a dedicated funding stream for hcw education and training and for funders to allow some project funds to be allocated to education and training. though undergraduate degree programs are provided in north west syria, they are unrecognised outside of the local area and the programs do not have accreditation. a number of attempts have been made to address this however none have so far been successful; this may present challenges for the graduates. a similar challenge occurred during the balkan conflict with the consequences for the hcw both during and after the conflict [ ] . after , many albanians lost their jobs leaving them without insurance; as a result, albanian health professionals set up a parallel primary healthcare system. albanian doctors and nurses, who were unable to study in their own language in pristina university were trained through this parallel health system during the s [ ] . however, though the doctors and nurses who graduated from this system may have had sufficient theoretical knowledge (clinical training was harder to obtain), this mode of training left a generation of albanian doctors and nurses with unrecognised qualifications, subsequently affecting their ability to work [ ] . as such, a similar scenario in north west syria, could leave thousands of hcws in north west syria with certificates or degrees which are not recognised outside of the region limited their career prospects; this could affect retention of hcws who may seek opportunities elsewhere though, conversely, it may support the retention of some hcws who are unable to leave the local healthcare system as a result. a group of hcws who have received little attention are those who have gained training in healthcare informally. these may be students who left their degrees due to the conflict but continued to work in hospitals or clinics or those who began providing healthcare to injured civilians and gained 'on the job' training particularly where there were shortages of trained hcws. they are disadvantaged even compared to those whose degrees or qualifications are unrecognised or unaccredited. due to the protracted nature of the conflict, many, particularly those who are wanted by the government, may have left syria to complete their studies elsewhere but others may have continued to work in the local health system gaining experience and attending courses providing by syrian ngos. according to uossm 's hospital surveillance, % of the nurses working in the north west fell into this category and there is concern as to what their role will be post-conflict as they have not participated in recognised training programs [ ] . however, with the role of newly established institutes, the idlib health directorate reports that this percentage is declining. (personal communication.) one of the roles of sboms has been to review this 'on the job' training in collaboration with the health directorates in north west syria with a view to identifying those who can receive credit for this. physicians in syria are highly respected and are often community leaders; during the course of the syrian conflict, many have established health or humanitarian ngos or taken leadership positions. this, together with the more standardised pathways for physician training, may have contributed to greater opportunities for physician compared to non-physicians hcws in north west syria. subsequently, the insufficient numbers of hcws in the area, have led to the recognition that increased focus on non-physicians hcws or on skill substitution (the transfer of tasks normally performed by doctors to other health professionals with different skills or levels of training) as potential solutions [ ] . skill substitution (formerly task shifting) has been discussed by the who and world medical association for some years and has an important future role in both high-and low-income countries as well as in humanitarian crises to reduce costs and meet the needs of the population [ ] . in north west syria, skill substitution has already occurred in some contexts; for example, specialised dialysis nurses had been taking the roles of renal specialists to oversee the estimated dialysis patients managed by syrian diaspora ngos in the north west; this was done with the support of the single remaining renal physician and a team of expatriate renal physicians providing training and advice. (personal communication) however, as yet, the acceptability of skill substitution to syrian patients amongst syrian hcws as one of the solutions has not been fully explored. this is particularly the case as proposed models which may be suited to other conflict affected settings, may not be as acceptable to the local population in syria due to the heavily medicalised and specialist model of the health system before the war [ ] . locally acceptable solutions are therefore urgently required given the massive skill and number shortage of hcws which is likely to persist for some years [ , ] . local and international political developments have a number of effects on hcw education and training. syria's health system is increasingly fragmented and politicised; in north west syria, there are shifts in groups who control the area and their influence over local institutions [ ] . for example, when the syrian salvation government took control of idlib and parts of the western countryside of aleppo, it insisted that local educational institutions be affiliated to it; this led some institutions to close and others to relocate. classes were interrupted and students staged sit-ins and called for politics to remain separate from education [ ] . (see fig. ). political influences are noted in other conflict affected contexts in gaza, iraq and the balkans [ , ] . hcws also face challenges crossing check points to attend training, examinations or to participate in educational activities in government controlled areas; reports of questioning and arbitrary arrests are widespread [ ] . any affiliation with a ngca institution has been considered criminal by the government of syria. as such, when the government of syria reclaimed aleppo, students burned their books and study materials to avoid being linked to one of the opposition-led universities which would result in arrest [ ] . students and faculty in government controlled areas would be stopped at university fig. free aleppo university graffiti in arabic which reads 'keep education separate from politics' and is dated th january . photo credit to free aleppo university or hospital checkpoints, questioned and sometimes arrested without charge. these individuals were arrested by security forces that had set up offices within university campuses, hospitals, or by appointed student members of the syrian student union. the offices of the student union were sometimes used as temporary detention centres for arrested students and faculty, and there have been documented instances of arrested hcw student and faculty being tortured in these offices before being taken to security force centres. some of those arrested later died under torture [ ] . the response to hcw education and training in north west syria has seen an important shift in the humanitarian system whereby local and diaspora led initiatives including from ngos have identified critical gaps in hcw education and training and sought to meet them [ , , ] . though this has occurred in other conflict affected settings e.g. gaza, iraq, balkans, the extent to which these organisations have responded to the needs in north west syria and their sustained attempts to meet critical gaps and to replace previous educational institutions and accreditation bodies has been more extensive than seen in previous conflicts [ , , ] . this may represent a shift change in the humanitarian system whereby hcw education (with regulation/ certification/ accreditation) is prioritised alongside other key sectoral needs, particularly for complex and protracted crises such as syria. this could draw on the experience of international organisations or ngos e.g. medicins sans frontieres [ ] with lessons learned in syria informing these discussions. while this manuscript focuses on north west syria, students in faculties of medicine or other health sciences in other areas of syria, including government-controlled areas have also suffered the effects of the conflict. students in government-controlled areas who could safely remain were able to complete their studies with a change in the regulations. students were allowed to fail up to or even classes of the required [ ] . students from al-baath, aleppo and al-furat could attend classes at safer campuses with thousands of students able to transfer to damascus or latakia universities. after the national hospital of homs was destroyed, agreements were made to allow students to take clinical placements at private hospitals. due to these exceptions, standardized final examinations were introduced for medicine, dentistry, pharmaceutical studies and nursing (as well as informatics engineering.) [ , ] . syria's protracted conflict has decimated its health system and led to a profound shortage of healthcare workers of sufficient number and skills, exacerbating pre-existing geographical inequalities. . both physician and non-physician healthcare worker undergraduate and post-graduate training has been affected across the whole of syria but the impact has been greatest in areas outside of government controlled, particularly in north west syria. . free aleppo university and idlib university and shabha university are the main public universities which provide undergraduate medical and pharmacy education in north west syria however they lack sufficient funds and faculty to support quality and sustainability. . there has been an unregulated growth in the number of private universities which provide undergraduate physician and nonphysician healthcare worker education. . unusually in a humanitarian response, non-governmental organisations have stepped in to provide some undergraduate courses as well as shorter, postgraduate continuous medical education opportunities for healthcare workers however this has been uncoordinated and unsustained. . there remains a gap in post-graduate physician training though organisations like the syrian board of medical specialties provide some opportunities though they are affected by poor funding and insufficient numbers of faculty with the specialties required. . challenges can be broadly divided into . organisational . programmatic and . healthcare system related . develop a locally driven healthcare worker education strategy for north west syria which is developed in close collaboration with key local and international stakeholders and which could lead to the formation of a consortium focused on healthcare worker education. . ensure dedicated funding streams for healthcare worker education which are multi-year and accessed through the consortium is the ideal but may be not be feasible; however, allowing funding as part of grants could allow dedicated funds for healthcare worker education. . develop relevant governance and regulatory structures which standardise the minimum quality of public and private educational establishments which deliver healthcare worker education. . develop strategic partnerships with international institutions which could support accredited and recognized courses for physician and non-physician healthcare workers in north west syria. this could be supported with more developed tele-education interventions. . increase focus on non-physician healthcare workers and skill substitution (task shifting) is required to ensure a healthcare workforce of sufficient skill and specialty to meet gaps. . conduct regular reviews of initiatives which have or have not been effective (e.g. quality, cost) in providing physician and non-physician healthcare worker education is needed to inform future initiatives. . continue to advocate for the protection of all health workers and healthcare provision in conflict, which is essential for the continuation of work and training without fear of attack. there are important topics which influence any discussion around the training of hcws in syria which have not been explored in this manuscript. these include the changing health needs of syria's population where there is a high burden of non-communicable diseases, conflict-related disability and a traumatised population [ ]; the severe psychosocial stresses experienced by the hcws both first-hand and as secondary trauma [ , , ] ; and the weaponization and destruction of healthcare in syria [ , , ] which affects hcws' ability to focus on their own education and training needs. table summarizes some of the key messages from this manuscript together with broad recommendations for the future. these recommendations need to be developed further with on the ground actors to ensure they are locally practicable and, given resource constraints, prioritized. challenges faced in delivering hcw education and training will affect the numbers, skills and distribution of hcws in north west syria both now and in the postconflict phase. improved coordination by all stakeholders with a medium and longer-term strategy that is implementable in the current context is needed. this requires sufficient and sustained investment from multilateral organizations, such as the un, and international donors. the situation in north west syria shares some similarities but also important differences in terms of hcw education and training during conflict. as such, lessons can be learned from the syrian context with opportunities to support earlier adoption of innovations e.g. tele-education, skill-substitution for both ongoing and future conflict-affected contexts and ensure robust leadership and governance. the need for this has been further underlined by the covid- pandemic which has highlighted the need for a robust healthcare workforce and healthcare systems which can effectively meet the needs of the response. lastly, we highlight that efforts in education and training for hcws without protection as stipulated under international humanitarian law are futile. world health organization. guide to health workforce development in post-conflict environments. world health organization health workers and the weaponisation of health care in syria: a preliminary inquiry for the lancet -american university of beirut commission on syria medical personnel are targeted in syria a map of attacks on health care in syria. physicians for human rights. the destruction of hospitals -a strategic component in regime military offensives health workers and the weaponisation of health care in syria: a preliminary inquiry for the lancet american university of beirut commission on syria. heal policy www strengthening human resources for health: integration of refugees into host community health systems human resource management in postconflict health systems: review of research and knowledge gaps the effect 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specialties-sboms-announces-the-general-rating-of-students-foradmission-to-blood-and-tumors-specialties in the midst of war, future syrian doctors trained with help from yale faculty, students | yale school of public health ualbany online science courses for refugee syria medical students training creates more support for vulnerable people in syria accessed quality midwifery care in the midst of crisis: midwifery capacity building strategy for northern syria the conclusion of the activity of medical education center to train reproductive health providers. | idlib health directorate accessed london calling gaza: the role of international collaborations in the globalisation of postgraduate burn care education using tele-education to train civilian physicians in an area of active conflict: certifying iraqi physicians in pediatric advanced life support from the united states impact of weekly case-based teleeducation on quality of care in a limited resource medical intensive care unit protecting healthcare in syria impact of conflict on medical education: a cross-sectional survey of students and institutions in iraq medical education in palestine losing their last refuge inside idlib's humanitarian nightmare a case study of health sector reform in kosovo wma resolution on task shifting from the medical profession -wma qualitative accounts from syrian health professionals regarding violations of the right to health, including the use of chemical weapons, in opposition-held syria international failure in northwest syria: humanitarian health catastrophe demands action publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations thank you to dr. abdullah suleiman terkawi (syrian expatriate medical association, us) and the syrian health professionals in syria and turkey who contributed valuable information. authors' contributions aa conceptualised, wrote the first draft and revised subsequent drafts. yb, as, dr conducted searches and interviews with key stakeholders. yb, dr, as, ae, lm revised and made significant contributions to subsequent drafts. ff, wk, mh, ae, tk revised drafts, contributed information and clarifications. no funding was sought directly for this work however as is partly funded by the academic foundation program of hull york medical school; the salaries of ff and ae are partially funded through the uk research and innovation gcrf research for health in conflict in the middle east and north africa (r hc-mena) project; developing capability, partnerships and research in the middle and north africa es/p / . wz is employed by sboms (syrian board of medical specialties) and receives a salary. dr is partly funded by elrha/ research for health in humanitarian crisis. there is no extra available data other than that which is quoted and referenced in the text.ethics approval and consent to participate no ethics approval or consent was required for this work. all authors have reviewed and provide consent for publication. author details key: cord- -jxjvimqd authors: azuine, romuladus e.; ekejiuba, sussan e.; singh, gopal k.; azuine, magnus a. title: ebola virus disease epidemic: what can the world learn and not learn from west africa? date: journal: int j mch aids doi: nan sha: doc_id: cord_uid: jxjvimqd with over , deaths and counting, and new cases identified in two developed countries that are struggling and faltering in their handling of the epidemic, the ebola virus disease (evd) epidemic is unlike any of its kind ever encountered. the ability of some poor, resource-limited, developing countries in sub-saharan africa to efficiently handle the epidemic within their shores provides some lessons learned for the global health community. among others, the evd epidemic teaches us that it is time to put the “p” back in public and population health around the world. the global health community must support a sustainable strategy to mitigate ebola virus and other epidemics both within and outside their shores, even after the cameras are gone. ebola virus must not be called the disease of the poor and developing world. in september and october, , the united states (us) and spain, respectively, became the first two developed countries of the world to record the diagnoses of ebola virus disease (evd) in their lands outside west africa during the current evd epidemic. for the us, it was the nation's first case of evd transmitted across international lines. the patient, now deceased, contracted ebola virus and travelled to us from his native liberia, one of the west african country at the center of what has become one of the most challenging infectious disease outbreaks and national security threats in modern times. [ , ] the other four countries are guinea, nigeria, senegal, and sierra leone. for spain, it was the nation's first case of an indigenous ebola virus infection for a nurse, who had earlier cared for two spaniard missionaries who later died from the virus which they contracted in west africa. [ ] with the death of the first patient in the us, subsequent infection of the nurses who cared for him, and the fears that more infections lay ahead, the us, and overall healthcare system in the western world, has come at the center of global scrutiny and debate. for the us and spain, the events around the evd cases have raised fundamental questions about the preparedness of the healthcare systems in advanced countries to handle the evd epidemic, should that occur, despite the rhetorical presentation of their sophistication and invincibility. in spain, federal authorities have asked for explanations on how the nurse contracted the virus. [ ] in the us, the ebola patient was released from hospital even after he reported that he had travelled from liberia only to be readmitted when his condition worsened. hospital and health officials have scrambled to advance such reasons ranging from human error, software malfunction, down to the assertion, in some quarters, that the patient was turned away because he did not have health insurance-the traditional gateway to getting into the healthcare system in the us. [ ] the unfortunate death of the us patient on october , , days after he was readmitted to the hospital, the first and only foreigner to succumb to evd within the us, where two prior us-citizenpatients were successfully treated, have set off a cascade of ethical and human rights questions and sometimes vituperations. [ ] given the historical and scientific antecedents of health disparities in the us, these reactions are understandable, and the fears are, to a large extent founded. plethora of research has documented that one of the leading and fundamental causes of health disparities in the us stems from the fact that minorities, the poor, and immigrants do not receive the same care in the us healthcare system as their majority, affluent, and native-born counterparts. [ , ] studies have also documented that minorities were less likely to be offered experimental treatments even when access was not the issue. [ , , ] the treatment or lack of treatment of the liberian-born ebola patient in the us has once again ignited somber thoughts of the past including the tuskegee experiments, where blacks in us were enrolled in clinical trials without their knowledge. [ ] the production of new experimental drugs, no doubt, takes a long time. it is also unknown if these experimental drugs work. [ ] however, many people, locally and internationally, have questioned the us public officials' moral high ground in asserting that the experimental zmapp, that drug was administered to the two prior us citizens, was unavailable for the treatment of the now deceased only non-us citizen-patient in the us soil. while these are continuing, news reports indicate that as many as over , people, and counting, have succumbed to this deadly virus in the affected west african countries at the time of this commentary. [ ] these affected west african countries already have among the world's worst global health indicators and need our help now (see table / figure ). the fact that advanced healthcare systems in the western world are grappling and failing with few cases of ebola, and its aftermath, tells us that this is not like any other. its present and future calamities cannot be wished away. ebola should not be relegated to the background as often happens to diseases afflicting the poor and developing countries. the global health community must not leave these nations at the mercy of a deadly virus. as part of its response, the us has deployed a contingent of about , soldiers to the affected west african countries to help them in setting up healthcare facilities to treat ebola patients. the fact that these soldiers were deployed by the president without the usual political arguments demonstrates the magnitude of risk perception among us law makers of the epidemic. the us has also instituted increased screening for airline passengers in the us and africa, [ ] a practice that had been in place since the outbreak started by the west african countries of liberia, sierra leone, senegal, and nigeria. the us has also dispatched a team of public health officials to learn how africa's most-populous country, nigeria, and senegal, among the world's poorest nation, were able to mitigate the spread of the virus in their countries. [ ] the us spends far more on healthcare than the ebola-hit west african countries combined (see table / figure ). the fact that the us is learning from nigeria and senegal is instructive. nonetheless, the turn of events with the ebola outbreak and matters arising therefrom raise a number of issues pertinent to our past and ongoing knowledge of global health. first, from the ebola virus we must learn that there is no geographic monopoly of the fountain of knowledge. learning can come from anywhere: the global south can teach the global north something. in , when the international journal of mch and aids (ijma) was established, one of the driving forces behind the nascent academic journal was predicated upon the fact that there is no geographic supremacy in the fountain of knowledge. ijma was founded to be "a fertile ground to cultivate a global intellectual coalition to highlight the issues in hinterlands of developing countries." [ ] it is interesting that the us is sending health experts to nigeria, the global south, to learn from their experience on handling the evd outbreak. this development buttresses the impe tus for knowledge sharing across the geogra phic boundaries of global north and south. second, the outbreak teaches us that public and population health can no longer be defined in terms of national boundaries. there is no longer a global or local/national health. global health is local health. it is often disappointing to come across public health experts, policy makers, or academics, who put an artificial divide between population health for those living within and those living beyond their national shores. the realities of the current ebola epidemic and past disease outbreaks such as sars (severe acute respiratory syndrome), bird flu (h n avian flu), bse (aka the mad cow disease), etc., present some of the profound reasons to agree that "local health is global health" and "global health is local health." this theme has not been lost in human ideologies. in , the world health organization (who) adopted the first international health regulations (ihr), the all-hands-on system designed to prevent national public health emergencies from becoming international crises. the present global outbreak alert and response network (goarn), while implementing the ihr strive to pool human and technical resources in member states from the global north and south. third, the handling, or mishandling, of the outbreak both in the developing and the developed world teaches us the critical importance of putting the "p" (public) back in public health. it is very often that we see policy makers and public health officials deal with public health issues in the abstract, reeling out mere numbers, policies and layers of guidance, but unfortunately relegating to the background, the public which is the very essence of public and population health. as depicted in the us experience, a sophisticated healthcare system is important in handling an outbreak such as ebola, but it is not a panacea to dealing with the attendant manageable fallouts of a rapidly unfolding outbreak. the people are. nigeria's ability to mitigate the catastrophic outbreak in africa's most-populous country was benchmarked on the nation's ability to mobilize the entire citizenry to participate in the national effort, a practice referred to in the language of epidemiologists as "contact tracing." while the country was battling the outbreak, every citizen became the guard and guardian of the entire society. nigeria's example typifies a community united in a fight against an outbreak with all that it has in its arsenal. people reported those in their neighborhoods who showed signs of evd and asked them to seek medical help. people were part of the overall "contact tracing" by using text messages to contact health officials. the role of the people was so instrumental that, at one time, the country was agog with the notion of a cure for evd by "bathing with salt." the fake cure started from a message sent out a local traditional ruler to his by subjects. this single communication went viral on the social media and everyone was bathing with salt water to prevent and or cure evd. even as unscientific as this incident is, the fact that this practice went viral within a few hours bears testimony to the level of communal sharing between people, friends, families, colleagues and even stran gers during such emergency. this is the "p" in public health in action. it is this "p" in public health that the western health officials must learn from their nigerian and senegalese counterparts. [ , ] it is easy to pontificate and write pages of protocols on how to handle a public health emergency. but the reality and effectiveness of planning is only evaluated when a healthcare system is confronted by the magnitude of an outbreak such as ebola. only then can we see the shortcomings of human planning vis-à-vis implementation and the need to understand that global health is local health, that the world can learn from each other, and finally that there is an urgent need to put the "p" back in public and population health. even as it puts in place multiple strategies to address the ebola in the country, the us, and other developed countries, must learn from history and resist attempts to use the outbreak to further alienate minorities and immigrant communities within their shores. as the world's global leader, the us must not allow what happened in its dealing with the first ebola virus disease patient to repeat itself and or obliterate its efforts to address racial and ethnic disparities in health. [ ] the numerous missteps, misspeaks, and misdeeds of the public health system in the handling of the ebola virus disease outbreak in the us and the western countries must stop. an efficient public health system must be color and statusblind and offer equal opportunities to all peoples regardless of their nationalities, racial/ethnic, or economic or social conditions. [ , ] for example, the governments must engage the public especially minorities, population characterized health dispari ties, and front line healthcare workers and reassure them that it is rolling out concrete steps to handle the outbreak. the public health system must take immediate actions to stem its failings in the handling of this volatile virus and its aftermath which is quickly eroding and putting a wedge in the public's trust of the entire public health system. above all, the global health community, led by the world health organization, must urge wealthy nations to afford equal access and opportunities to public health and clinical trials products to all peoples within their shores irrespective of ability, or socioeconomic status. financial disclosure: none. funding support: none. conflicts of interest: no authors have financial interests that pose a conflict of interest. world health organization. global alert and response (gar) ebola (ebola virus disease) ebola outbreak: nurse infected in spain. british broadcasting corporation marked ethnic, nativity, and socioeconomic disparities in disability and health insurance among us children and adults: the death of thomas eric duncan in dallas fuels alarm over ebola new york times widening socioeconomic, racial, and geographic disparities in hiv/aids mortality in the united states immigrant health inequalities in the united states: use of eight major national data systems ethical aspects of clinical research health inequalities and infectious disease epidemics: a challenge for global health security questions and answers on experimental treatments and vaccines for ebola us centers for disease control and prevention nigeria contains ebola -and us officials want to know more. yahoo/christian science monitor addressing global health, development, and social inequalities through research and policy analyses: the ebola virus disease outbreak -nigeria importation and containment of ebola virus diseasesenegal ebola crisis: texas hospital apologises for failures in handling of first patient. the guardian key: cord- - hto qn authors: schoch-spana, monica; brunson, emily k.; long, rex; ruth, alexandra; ravi, sanjana j.; trotochaud, marc; borio, luciana; brewer, janesse; buccina, joseph; connell, nancy; hall, laura lee; kass, nancy; kirkland, anna; koonin, lisa; larson, heidi; lu, brooke fisher; omer, saad b.; orenstein, walter a.; poland, gregory a.; privor-dumm, lois; quinn, sandra crouse; salmon, daniel; white, alexandre title: the public’s role in covid- vaccination: human-centered recommendations to enhance pandemic vaccine awareness, access, and acceptance in the united states date: - - journal: vaccine doi: . /j.vaccine. . . sha: doc_id: cord_uid: hto qn given the social and economic upheavals caused by the covid- pandemic, political leaders, health officials, and members of the public are eager for solutions. one of the most promising, if they can be successfully developed, is vaccines. while the technological development of such countermeasures is currently underway, a key social gap remains. past experience in routine and crisis contexts demonstrates that uptake of vaccines is more complicated than simply making the technology available. vaccine uptake, and especially the widespread acceptance of vaccines, is a social endeavor that requires consideration of human factors. to provide a starting place for this critical component of a future covid- vaccination campaign in the united states, the -person working group on readying populations for covid- vaccines was formed. one outcome of this group is a synthesis of the major challenges and opportunities associated with a future covid- vaccination campaign and empirically-informed recommendations to advance public understanding of, access to, and acceptance of vaccines that protect against sars-cov- . while not inclusive of all possible steps than could or should be done to facilitate covid- vaccination, the working group believes that the recommendations provided are essential for a successful vaccination program. since its first appearance in the united states in february , the novel coronavirus (sars-cov- ) has infected over . million americans and killed over , (as of october , ) [ ] . responses to the virus, including closing venues where person-to-person spread was likely, and requiring the use of masks and physical distancing measures when social contact could not be avoided, have reduced virus spread. at the same time, these protective actions have radically transformed social life and disrupted national and household economies [ ] . as the health crisis continues to linger and a sense of pandemic fatigue starts to take hold, political leaders, health officials, and the general public are seeking solutions [ ] . one of the most promising, if successfully developed and deployed, is vaccines. this technology could provide individual and population-level immunity, and through these the eventual conditions for the resumption of routine social and economic activities [ ] . to facilitate the development and dissemination of such vaccines, the us government has committed over billion dollars (via operation warp speed) with the aim of delivering million doses of a safe, effective vaccine by january [ ] . while this timeline is likely overly optimisticvaccine development, especially against a class of pathogens for which no licensed vaccine currently exists, typically takes - years [ ] -progress is being made. as of october , , vaccines are in preclinical evaluation, are in phase i and ii safety trials, have entered phase iii efficacy trials, and five vaccines have been approved for limited use: two in china, two in the united arab emirates, and one in russia [ ] . despite these promising developments, operation warp speed manifests a key social gap. the program rests upon the compelling yet unfounded premise that 'if we build it, they will come.' past experience in routine and crisis contexts demonstrates that, for a variety of reasons, not all segments of the public will accept medical countermeasures including vaccines [ ] [ ] . a recent poll in the us suggests this is already the case for sars-cov- (covid- ) vaccines. about half of us adults ( %) reported they definitely or probably would accept the vaccine, while % said they would not [ ] . in the same poll, only % of black americans indicated they would definitely/probably accept the vaccine compared to % of white americans. a human factor-centered vaccination campaign is needed to address these issues, but this campaign must be effectively planned and implemented. if poorly designed and executed, a covid- vaccination campaign could undermine increasingly tenuous beliefs in vaccines and the public health authorities that recommend them. at the same time, the broad impacts of a successful vaccination program would be considerable. immediate benefits would include interrupted disease transmission; fewer cases, hospitalizations, deaths, and chronic sequelae; and the beginning of reinstated social and commercial exchanges. longer term effects would include improved institutional capabilities to foster vaccine confidence among diverse communities, enhanced public understanding regarding vaccination's value to society, and heightened public trust in government, science, and public health. the purpose of this article, which is based on a report on the same topic [ ] , is to outline the major challenges and opportunities associated with a future covid- vaccination campaign and to provide empirically-informed recommendations to advance public understanding of, access to, and acceptance of vaccines that protect against sars-cov- . with the current lag time in vaccine availability, vaccination planners and implementers in the us and around the world have the opportunity to exercise foresight and take proactive steps to overcome potential hurdles to vaccine uptake and maximize public acceptance. these steps, however, must be taken now before this critical window of opportunity closes. the research and recommendations presented in this paper are a product of the -person working group on readying populations for covid- vaccine (table ) . this group was convened in april by principal investigators from the johns hopkins center for health security and the texas state university department of anthropology with support from the national science foundation-funded converge initiative [ ] . the purpose of the working group was to develop and disseminate recommendations informed by design thinking and evidence from social, behavioral, and communication sciences, that would support realistic planning for a us covid- vaccination campaign. members of the working group-listed as authors on this paper-included national figures in public health and social science with research, policy, and practice expertise in vaccinology, vaccine hesitancy/confidence, health disparities, infectious disease, bioethics, epidemiology, bioinformatics, public health law, pandemic mitigation, public health preparedness, mass vaccination campaigns, community engagement, and crisis and emergency risk communication. a combination of literature reviews on vaccination, pandemic planning, and health crisis communication; an assessment of current news and social media trends regarding covid- vaccines; and key informant interviews with each working group member focusing on their respective expertise formed the basis of the research presented in this article. this research was refined, and the recommendations were developed, through an iterative process involving the development of draft reports by a core working group, feedback from the entire working group via email and comments provided during a virtual meeting on may , , and subsequent rounds of revisions and feedback (including a second virtual meeting on june , ). the final report from the working group, which forms the basis of the recommendations and best practices below, was finalized on july , . envisioned largely as a biotechnology and logistics challenge, covid- vaccination also poses complex human factors challenges. such challenges have been observed during past emergencies. in , for instance, many americans rejected the h n vaccine due to safety concerns [ ] , despite the fact that the vaccine only involved a strain change (i.e., it was not a new technology) and was fully tested before release. the h n vaccine also amplified perceptions of bias. in los angeles, for example, distrust in public health-resulting from both prior experimentation on blacks (e.g. the tuskegee syphilis study) and long-term discrimination of blacks in health care settings [ ] [ ] [ ] -led local faith-based leaders, radio personalities, and other community representatives to advise black community members to avoid vaccination [ ] . even though the los angeles county health department actively sought to address these concerns, these suspicions coupled with a lack of convenient access to h n vaccines ultimately resulted in many blacks in this community remaining unvaccinated [ ] . despite the existence and importance of such challenges, funding for research on human factors related to vaccine acceptance is not commensurate with its significance for vaccination success [ ] [ ] . this type of inquiry-practical research of a social and behavioral nature on a medical technology-generally falls between the priorities of the national institutes of health ([nih] which rarely funds social science research) and the national science foundation (which does not fund applied public health research). funding from other sources including the centers for disease control and prevention (cdc) and private foundations has also historically been limited. in addition, the existing funding infrastructure is not outfitted for rapid response research during dynamic crises like sars-cov- . while initiatives are underway to develop communities of practitioners and a supportive infrastructure for disaster science in the us, including professional networks, streamlined institutional review board processes, and joint responder-researcher training [ ] [ ] , more progress is needed especially in regards to rapid funding opportunities. in the case of sars-cov- vaccination, for instance, while an nih funding opportunity award that could support research on human factors related to vaccine acceptance was made possible in june , the earliest project start date is september , a full nine months after operation warp speed plans for covid- vaccines to become available [ ] . to ensure a successful covid- vaccination campaign, it is necessary for sponsors to invest in time-critical investigations on human factors related to vaccine acceptance, and for public health authorities and other stakeholders to act on the social and behavioral findings of this research. such efforts include:  reconfiguring existing research investments to include social, behavioral, and communication science. one possibility for this is to set aside a small portion of the operation warp speed budget for research on human factors related to vaccine acceptance. such an approach has been used with great success in the past with other cutting-edge scientific initiatives such as the human genome project and manned space flight [ ] [ ] [ ] .  embeding rapid social, behavioral, and communication science within the covid- response, helping to deliver timely data and empirically based advice. by including social scientists in planning and implementation efforts, their people-centered methodologies and specialized knowledge can be integrated in a timely manner to maximize critical insights [ ] [ ] [ ] [ ] [ ] .  transforming the vaccine research enterprise by involving communities as active partners not passive subjects. traditional "one-sided, top down" approaches to community engagement are not always effective. community partnerships during the west africa ebola outbreak, for example, were necessary to overcome issues of trust and produce needed behavioral changes [ ] [ ] .  applying human-centered design principles (aka "design thinking") to the planning and implementation of the covid- vaccination program. user-focused approaches can result in more usable, acceptable, and effective interventions compared with traditional expert-driven methods [ ] [ ] . such an approach has been very successful in promoting hpv vaccination [ ] . vaccines typically require years of development and testing before licensure. nonetheless, us political leaders have publicly promised to accelerate covid- vaccine development at "an unprecedented pace," with the aim of delivering million doses of a safe and effective vaccine by january [ ] . although the use of new technologies can potentially accelerate vaccine production, public expectations around vaccine availability may not align with the practical realities of vaccine development, licensure, manufacture, and distribution. by failing to deliver sars-cov- vaccines as promised, the us government could frustrate pandemic-weary communities, siphon away trust, and suffer a major loss of institutional legitimacy. this situation is further complicated by public perceptions of the risks and benefits of sars-cov- vaccines. recent polling suggests that increasing numbers of americans plan to reject covid- vaccines, even if they are available and affordable [ , ] . a review of news reports, blogs, and other social media suggests a variety of potential causes for this result, including nonchalance about the disease and concern about vaccine safety. public perception, however, is a moving target. new developments, for example, an emergency use authorization (eua)-a power granted to the food and drug administration (fda) to make unlicensed drugs, vaccines, or other therapeutics available during a public health emergency, provided sufficient evidence that the countermeasure in question "may be effective"-for covid- vaccines, could engender additional uncertainties around vaccine safety due to the public's lack of familiarity with this complex regulatory mechanism. whatever the public's beliefs about vaccine benefits, risks, and supply, they cannot be separated from the current cultural milieu. in the us this is currently characterized by division, partisanship, and eroding public trust in government institutions-including the biomedical and public health agencies tasked with overseeing vaccine development, licensure, and distribution. in relation to the latter, for example, the intellectual independence of the fda has come under scrutiny for its ability to objectively assess vaccine safety and efficacy amid immense political pressure to quickly approve a sars-cov- vaccine [ ] . this complicated social environment poses a distinct and unprecedented complication to all vaccine promotion efforts in the us. amid this increasingly complex social landscape, there are several measures that us public health and healthcare practitioners, political leaders and policymakers, and communication experts can implement to prime the general public for sars-cov- vaccines including:  tempering expectations of vaccines as a "quick fix." because covid- vaccines will not immediately be available to everyone who wants them, and time will be needed to develop immunity (especially given the likelihood of two-dose regimens), communicators must prepare the public to continue implementing a mix of protective actions and harm reduction strategies.  forecasting a range of vaccine possibilities: from best case to worst case scenarios regarding vaccine supply and effectiveness. from a position of openness and transparency, public health communicators should address inevitable roadblocks and bottlenecks at every stage of vaccine testing, licensure, distribution, and administration, and convey to the public how this could affect vaccine availability. in addition, it will be necessary to reframe the dialogue about the value of vaccines, given that future sars-cov- vaccines may be not be the public's hoped for silver bullet. a vaccine, for example, may prevent the most severe disease but not prevent sars-cov- infection. in this scenario, vaccination could keep hospitals from being overwhelmed, prevent declines into frailty after severe bouts of disease, and avert medical bankruptcies that may arise with the longer-term impacts of covid- , but not provide the community immunity necessary to halt the spread of sars-cov- .  persisting in transparency around vaccine safety systems and actively work to protect their integrity. health authorities should focus existing vaccine safety infrastructure on the use of sars-cov- vaccines. in this vein, health authorities should develop a robust system for post-licensure surveillance, including ascertaining background rates of anticipated adverse events prior to vaccine rollout to enable comparison with post-rollout incidence of adverse events. independent oversight of vaccine safety, as occurred during the - h n pandemic, should also be used [ ] .  early on, seeking the counsel and input of communities of color that may have historic reticence towards public health. vaccine promotion efforts should engage these communities early and as frequently as possible. as partners in the task, they must also empathize with legitimate concerns around vaccine safety, medical experimentation, and inequalities in health care [ ] [ ] , while also identifying and sharing salient information that can help assuage unwarranted worry. a profusion of true and false information, which the who recently referred to as an "infodemic" [ ] , is now circulating around covid- . in this crowded information landscape, the veracity of information can be difficult to determine and key messages can be lost. in the us, public discourse on the pandemic currently incorporates a panoply of topics including science, public health, social disruptions, political divisions, and economic fallout [ ] , each of which can be a vehicle for misinformation-information that differs from expert consensus at the time it is shared [ ] . while many reasons exist for this flood of misinformation, including the widespread public adoption of social media platforms as a tool for information seeking, the uncertain nature around covid- as a novel infectious disease, and the presence of disinformation campaigns aimed at deflecting blame and pushing false narratives around the global covid- response [ ] [ ] [ ] , no easy solutions exist to stem the tide [ ] [ ] . regarding covid- vaccination specifically, while the first vaccine is minimally months away from materializing, the topic has already commanded immense public attention and generated its own pool of misinformation [ ] [ ] . this ranges from rumors questioning vaccine safety to more complicated narratives suggesting that future covid- vaccines were created alongside the virus and that major organizations are planning to use a covid- vaccination campaign for financial gain [ ] [ ] . while not the sole factor in determining behavior adoption, effective communication is necessary to address these issues and build public confidence in covid- vaccination [ ] . such communication will require addressing the enduring problem of how to best engage, exchange information, and empower audiences who have diverse beliefs and life circumstances. past communication experience with vaccines has shown the importance of engaging with key audiences to understand their concerns, values, attitudes, perceptions, and beliefs [ ] [ ] [ ] [ ] , and using this understanding to develop messages that resonate [ ] [ ] . messages that do not do this are often ineffective and, worse, can move audiences further away from the desired behaviors [ ] . given the diverse nature of social identities in the us, covid- vaccination communications will need to be tailored to meet the needs of specific audiences including essential workers, parents, groups with high comorbidity rates, and communities of color.  investing in qualitative research to identify specific community concerns and hopes in relation to covid- vaccination. qualitative research can provide insight into "how" and "why" participants feel, think, or behave a particular way [ ] [ ] . such insight, in turn, is the basis for developing more meaningful, trusted, and influential communication strategies [ ] . the current climate of racial, political, and economic division in the us has created a charged environment that necessitates both a fair vaccination campaign and widespread, public recognition of its fairness. an initial test of this will be how limited, initial doses of vaccines are allocated. in past public health emergencies, including the - h n pandemic, allocation strategies have been used to prioritize delivery of medical countermeasures to specific groups like critical health care workers and those who are at particular risk [ ] . pervasive racial biases in the us healthcare system, including lack of insurance and a lesser quality of care for non-white, rural, and low-income populations [ ] [ ] [ ] . such disparities have long-term consequences. black populations in the us, for example, experience increased morbidity and mortality compared to their white peers, sometimes in ways that cannot be accounted for by access to health care and income [ ] . public health authorities will need to anticipate and mitigate public discourse regarding vaccine allocation and distribution along with prejudicial ideas about social worth, explaining that vaccinating individuals residing in the us, regardless of social or legal status, is critical to the public's health as a whole. finally, politicization of the pandemic-both real and perceived-may prime expectations of a partisan-based vaccine allocation and distribution rather than an equitable one. some americans, for instance, perceive the use of masks as a slight against president trump by his detractors [ ] . likewise trump has signaled his preference for having a vaccine available prior to the election (a projection not in keeping with expert assessments), prompting concerns about whether he could turn a potential but inadequately tested vaccine into a campaign tool [ ] . such polarized views of covid- raise concerns about whether vaccine allocation and distribution can and will be judged as fair by the majority of americans. people will judge a covid- vaccination campaign's integrity not simply on biomedical merits, but on matters of fairness and equity-that is, have people received their just portion of health services, and has disease prevention, ultimately, been fairly distributed? past experience suggests the following steps may contribute to a fair process:  the us government taking steps to make the vaccine available at no cost to all americans and publicly pledge that everyone who wants covid- vaccines will get covid vaccines. removing cost as a barrier is among the most significant ways to assure that all individuals benefit from the life-preserving benefits of sars-cov- vaccines, and that the public can have the utmost confidence that public health needs and not economics will determine access. in the time that exists before vaccines are produced it is critical that safe and accessible vaccination sites are identified. this process will require ramping up the use of sites that are already available and accessible, but are used less frequently for vaccination efforts. community pharmacies, for example, are widespread and have been mobilized for past vaccination efforts [ ] . to fully utilize pharmacies in covid- vaccination efforts, however, it will be necessary to address state-level policies that may currently preclude pharmacists from administering these vaccines without standing orders from physicians. other nontraditional, potential vaccination settings that should be considered include grocery stores, senior citizen centers, workplaces, and schools [ ] [ ] [ ] [ ] [ ] . in some cases, it also may be acceptable and feasible to deliver vaccination via home visits by community health nurses when vaccination is bundled with delivery of other preventive health services; this approach has received a strong recommendation in the past from the community preventive services task force [ ] . for marginalized populations, including racial and ethnic minorities, additional consideration must be given to what constitutes a "safe" vaccination site. during the - h n pandemic, for example, mistrust and fear among marginalized communities posed a challenge. latino farmworkers were at greater risk for h n -related morbidity and mortality. however, reports of bullying and harassment within and outside of local healthcare settings led many members of this population to be fearful and hesitate to seek out h n vaccination [ ] . while national patterns may exist, assessments of what constitutes safe vaccination sites for marginalized populations should be conducted at local levels. once vaccination sites are identified, it will be essential for public health authorities to disseminate up-to-date, comprehensible, and trustworthy information about vaccination opportunities. much of this communication work will be done by local and state health departments, which may be challenging in light of budget cuts and strained local public health infrastructure. an additional complication will be the likely complex covid- vaccination environment, characterized by multiple manufacturers, multiple vaccine doses, and differently timed follow-up doses. making vaccines widely accessible is a complex endeavor. past experience suggests that this is possible with proactive, thoughtful coordination and clear communication like the following:  utilizing nontraditional vaccination sites like schools, pharmacies, places of worship, workplaces, grocery stores, health departments, mass vaccination clinics, senior centers, home visits, and others. utilizing these sites, as well as clinical sites that already serve vulnerable or underserved populations (e.g., free/low cost community health care clinics, std clinics, substance use treatment centers) will be important to improve uptake in populations that outreach efforts have failed in the past.  preparing, in advance, all necessary educational materials and training that may be needed for those tasked with vaccination at nontraditional sites. training may include information on how to look up immunization records in state immunization registries, how to safely store vaccines, and how to safely recommend vaccines for targeted populations, keeping in mind any contraindications.  anticipating hesitancy among marginalized populations who may be fearful or wary of seeking vaccination at sites that have historically caused mistrust, and plan to either expand sites to better serve these populations or engage these populations early to earn and build trust. this may require using novel sites to better serve marginalized populations (e.g., places of worship, schools, culturally specific community centers or senior centers, mobile clinics). these nontraditional settings will also require those administering vaccines to be culturally competent. vaccination sites should not be heavily policed or send any signals that they may be somehow unsafe for vulnerable persons.  fostering collaboration among interagency and nongovernment partners to make vaccination available alongside provision of other safety net services. bundling services that address individuals' broader needs during the pandemic (e.g., food security, rent assistance, workforce development) could be a way to build trust, streamline vaccine provision, and enhance more convenient access for community members. the protracted covid- pandemic has placed multiple stresses on the american people: the threat of illness and death, the isolating effects of physical distancing measures, and the uncertainties and hardships associated with disrupted economic and schooling activities. the public's patience is understandably wearing thin. operation warp speed is taking revolutionary steps to develop sars-cov- vaccines as swiftly as possible and, along the way, to inspire hope that relief from the pandemic's multiple burdens is coming. despite vaccination's promise of release from the confines of the pandemic, some members of the us public-including those most at risk of covid- 's impacts-are already reluctant to embrace this public health measure [ ] . likewise, current protests against nonpharmaceutical interventions to the sars-cov- crisis, including criticisms about government over-reach, encroachment on individual freedoms, and a clash of personal values, have the potential to further erode public trust in future sars-cov- vaccines. under these circumstances, bold measures are necessary to instill public trust and to change the reality and the perception that covid- vaccination is a top-down program administered without regard to public sentiment, concerns, or priorities. one potential solution to these issues is the formation of public oversight committees at state and, in large metropolitan areas like new york and los angeles, local levels. governance structures that incorporate public oversight and community involvement have the potential to inspire greater public confidence in, and a sense of ownership over, public health interventions. such "ownership" can fortify the intent to vaccinate and strengthen distribution systems to reach throughout communities, thus helping to assure the fitting and fair use of a public good. this type of community engagement entails the collaboration of affected and at-risk populations with policymakers and practitioners in the generation, implementation, and evaluation of measures to safeguard public health and safety [ ] [ ] [ ] . an accountability mechanism and metrics will be necessary to ensure that allocation is fair, target groups receive vaccine, and underserved populations that have been disproportionately affected during the pandemic are justly attended. while vaccines represent a promising solution to the covid- pandemic, the development of vaccines is only part of the answer. widespread acceptance of vaccines is also needed. this acceptance, in turn, requires more than just making safe and effective vaccines available. it is a complex social endeavor that necessitates deep engagement around the human element, and requires the efforts of us policymakers; federal, state, and local public health officials; private funders; professional and community organizations; university researchers; and nontraditional partners. while the content provided in this article is not all-inclusive of what can, or should, be done to support widespread acceptance of covid- vaccines, the recommendations and best practices outlined here are important for such a vaccination program to be successful. as experts in a wide variety of vaccination-related topics, we fear that unless these critical steps are taken, any future covid- vaccination campaign will be less than hoped for. a worst-case scenario would involve an inability to stop the ravages of the disease and its cascading social and economic effects; further erosion of public trust in government, public health, and vaccine science; and potential threat to other life-preserving and live-enhancing vaccination efforts. that said, a successful covid- vaccination endeavor promises an alternative future: a return to a sense of normalcy, major innovations in vaccine research and operations, and the investment of us society as a whole in making vaccines a public good in which all can share and derive value. establish public oversight committees to review and report on systems affecting public understanding, access to, and acceptance of covid- vaccines usg should sponsor a national panel entity 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national survey of pharmacy-based immunization services safety of influenza vaccinations administered in nontraditional settings centers for disease control and prevention. national and state-level place of flu vaccination among vaccinated adults in the united states flu season polio: an american story increasing appropriate vaccination: home visits to increase vaccination rates stigma, health disparities, and the h n influenza pandemic: how to protect latino farmworkers in future health emergencies community engagement, organization, and development for public health practice community participation for transformative action on women's, children's and adolescents' health on behalf of the working group on community engagement in health emergency planning. community engagement: leadership tool for catastrophic health events key: cord- - b hm e authors: sariola, salla; gilbert, scott f. title: toward a symbiotic perspective on public health: recognizing the ambivalence of microbes in the anthropocene date: - - journal: microorganisms doi: . /microorganisms sha: doc_id: cord_uid: b hm e microbes evolve in complex environments that are often fashioned, in part, by human desires. in a global perspective, public health has played major roles in structuring how microbes are perceived, cultivated, and destroyed. the germ theory of disease cast microbes as enemies of the body and the body politic. antibiotics have altered microbial development by providing stringent natural selection on bacterial species, and this has led to the formation of antibiotic-resistant bacterial strains. public health perspectives such as “precision public health” and “one health” have recently been proposed to further manage microbial populations. however, neither of these take into account the symbiotic relationships that exist between bacterial species and between bacteria, viruses, and their eukaryotic hosts. we propose a perspective on public health that recognizes microbial evolution through symbiotic associations (the hologenome theory) and through lateral gene transfer. this perspective has the advantage of including both the pathogenic and beneficial interactions of humans with bacteria, as well as combining the outlook of the “one health” model with the genomic methodologies utilized in the “precision public health” model. in the anthropocene, the conditions for microbial evolution have been altered by human interventions, and public health initiatives must recognize both the beneficial (indeed, necessary) interactions of microbes with their hosts as well as their pathogenic interactions. the anthropocene marks the end of a period characterized by the human triumph of nature, and nowhere is this more prominent than in public health. the heroic era of microbiology made pasteur, koch, lister, and fleming household names, and few have done more for humanity [ ] [ ] [ ] . the lifespan of a newborn parisian was years in ; and a century later, a newborn parisian could expect to live another years [ ] . much of this increase in life expectancy (as well as the expectation to be healthy) has been due to the ability of public health measures-proper sanitation, food surveillance, antisepsis, and anti-viral vaccination-to remove humans from sources of microbial infection. however, our relationship with microbes and their evolution has changed dramatically since the discovery of antibiotics, and the conquest of polio and other endemic viruses in the s and s. the first part of our changing relationship to microbes involves the western world's manufacturing an environment that is increasingly sterile and characterized by the removal of unplanned and unplannable nature [ , ] . indeed, nature is no longer our "state of nature." rather, we have continually separated ourselves from nature, separating the "who" of human lives from the "what" of other lives. and immune systems of plants and animals and ( ) the microbes' ability to transfer dna horizontally from organism to organism. this article attempts to map out a holobiont perspective to public health. it is important to determine how these new views of microbial evolution-lateral gene transfer and mutualistic symbiosis-might be integrated into public health initiatives. it seems that present initiatives ignore or marginalize these phenomenon and that public health might be served better if they were made more central. two pertinent public health paradigms that have received much publicity in recent years are the "precision public health" (pph) paradigm and the "one health" (oh) paradigm. neither of these appear to take seriously our new appreciation of microbial evolution. precision public health (pph) is the application of genomics technology for population health benefits [ , ] , and it is the attempt to make public health into a genomic science. pph began in , when the office of public health genomics of the cdc was formed to "transform" population health care into a genomic science "by identifying, evaluating, and implementing evidence-based genomics practices to prevent and control the country's leading chronic, infectious, environmental, and occupational diseases" [ ] . pph claims that it would be able to analyze one's genome and then prescribe the appropriate drugs and dietary regimens. however, the original promises that genomic science would find common alleles for common diseases were not fulfilled [ , ] . genome-wide association studies (gwas) for cardiovascular disease showed that that genes played a negligible role in predicting heart attacks and that human genetic variation accounted for roughly % of the variation in blood pressure [ ] . moreover, the prediction that a patient would have a heart attack was better made by the number of pushups a patient could do than by genomic analyses [ ] . the genes thought to be associated with depression were "lost" when large trials were done [ ] ; and deficiencies of the gut microbiome may provide a better account of causation [ ] . worse, for any genomic model of public health, was when the genome of the founder of the human genome project, james watson, was analyzed. his dna sequences predicted him to be deaf, blind, growth retarded, and mentally deficient [ , ] . genes work differently in different people. "phenotypic heterogeneity," wherein the same mutant allele causes different phenotypes in different individuals carrying it, is a well-known phenomenon in medical genetics [ , ] and a gene that is "normal" in one generation can cause disease in another [ ] [ ] [ ] . nevertheless, the pph got a shot in the arm (to use an old public health metaphor) by the "all of us" project begun at the usa's national institutes of health [ ] . its website proclaims this to be a big genome, big data approach to public health, whereby "taking into account individual differences in lifestyle, environment, and biology, researchers will uncover paths toward delivering precision medicine..." pph is getting a shot in the other arm from pharmacogenomics, the study of how responses to drugs are influenced by the genetic makeup of the person receiving the drug. according to kapoor et al. [ ] pharmacogenomics, is "one of the cornerstones of precision medicine" and furthermore, is a "significant innovation in health care that possesses the potential to change the paradigm in the practice of medicine, not solely in the way drugs are prescribed, but also in the way drugs are discovered and developed." indeed, precision pharmacogenetics is being touted as a paradigm for third-world health care [ ] . however, this population-centered model of genomic healthcare delivery has been criticized [ ] as being a salvage attempt to rescue something of value from the numerous extremely expensive genome projects that had been the scientific rage of the late th and early st centuries. reardon and others [ , , ] claim pph is most likely dangerous fantasy, exacerbating global economic differences, taking the "public" out of "public health," and shifting responsibility for health onto the individual citizen [ , ] . pph has also been criticized for not recognizing the contributions of the symbiotic microbial genomes [ ] . symbiotic relationships with microbes, as will be discussed below, provide essential metabolic pathways for phenotype production (including those for drug metabolism) and over ten-fold the number of different genes than the zygote-derived genome. whereas precision public health works from one privileged level-the genome-up to humans and human communities, the one health paradigm is consciously interdisciplinary and multi-species-it attempts to envision people, animals, and environments as partners in each other's health on several levels [ , ] . as gibbs [ ] (p. ) notes, "one health is the collaborative effort of multiple disciplines-working locally, nationally, and globally-to attain optimal health for people, animals, and our environment." the one health paradigm, according to friese and nuyts, provides a theoretical basis for research involving nonhumans in public health and used to re-organize relationships between human medicine and animal veterinary medicine so that these two fields communicate in both knowledge and practice [ ] . with contributions from such disciplines as ecosystem services and soil microbiology, one health approach also recognizes the role of environments and ecologies in how human and animal health is shaped. these contributions see ecosystems (including symbiotic microbiomes) as providing economic infrastructure benefits that can be calculated as part of any managed change to the environment [ ] [ ] [ ] . however, overall, the implementation of one health is still fixed on protecting humans from zoonotic infections [ ] . indeed, the cdc, who, ama, and avma websites stress zoonoses and the fact that most infectious diseases are spread by animals. the environment gets short shrift in these sites, and this deficiency has not gone unnoticed. numerous investigators have documented that the environment does not receive attention or funding in most one health networks [ ] [ ] [ ] [ ] . thus, the three components of the one health model are not equal, and the framework is still used to prioritize protection of humans from zoonotic diseases. while the importance of this goal is made obvious in this coronavirus-infused decade, the anthropogenic deterioration of the environment by humans-such as mountain-top coal removal, anthropogenic deforestation, soil microbial deterioration, and reef depletion-are crucial in and of themselves as well as can have enormous effects on public health and do not appear on the one health agenda. only recently have there been calls to put microbes and global climate change under the one health umbrella [ , ] . some of these initiatives have come under the planetary health [ ] , which emphasizes how critical such ecological perspectives are for human health. the planetary health perspective, however, concentrates on the important issues of politics and economics of global health care in the anthropocene, but it does not address the issues the changes in how we perceive microbes. in contrast to the precision public health and one health paradigms, a recently proposed theory holds that microbes such as bacteria are primarily beneficial symbionts of the human body, and their presence is both expected and necessary for normal human health. while pathogenic microbes can cause enormous damage, they are a distinct minority, and public health needs to recognize the other arm of symbiosis-mutualism. this approach, which could revitalize the community-based one health perspective to public health by using the techniques of the molecularly based pph model, is based on the hologenome theory [ ] . this model has recently received support by private funding, most notably from the bill and melinda gates foundation [ , ] . the hologenome theory [ , ] recasts the individual animal or plant (and other multicellular organisms) as a consortium ("holobiont")-the host plus all its symbiotic microbes. during the past two decades, advances in microbiome research have clearly shown that most animals cannot normally develop, function, or reproduce without the vast numbers of microorganisms that inhabit their bodies [ , ] . microbes are essential for normal animal development and physiological functioning. for instance, bacteria acquired at birth from the female reproductive tract are critical to the construction of the gut capillaries and epithelia in several vertebrates [ ] [ ] [ ] [ ] [ ] as well as being critical for the normal development of the vertebrate enteric and cerebral nervous systems [ ] [ ] [ ] . pediatric geneticist barton childs [ ] postulated that each person's genetic endowment constitutes a "biochemical individuality" conferred upon us by our genes. patterson and turnbaugh [ ] have used the same term to designate the properties of the "hologenome"-the genes we inherit from our parents and our microbes, our germ cells and our germs. while we inherit some , genes from our parents, we inherit about million different genes from our parents' bacteria [ ] . indeed, in some instances, the gut microbiome appears to be critical in drug metabolism. digoxin, cyclophosphamide, and numerous other drugs are each metabolized differently by different populations of microorganisms [ ] [ ] [ ] , giving each person an assortment of genes (and drug-metabolizing phenotypes) that can change with each meal [ ] . even the human immune system, so critical in public health, is a holobiont property, and not merely the agency of the host [ ] [ ] [ ] [ ] [ ] . microbes enter into the body at birth, prior to the maturation of the immune system, and they induce the formation of lymphoid tissues [ ] [ ] [ ] . moreover, these lifelong immune activities are well-regulated only in the continuous presence of microbes, which in turn, constantly regulate the microbes that can stay with the animal [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the immune system is a continuously co-constructed property of the holobiont. holobiont public health recognizes that microbes may be pathogenic or beneficial, and that deficiencies in bacteria can cause developmental, immunological, cognitive, and physiological ailments. for instance, kwashiokor, long seen as a protein deficiency disease, manifests as a wasting and anorexic pathology only when certain bacteria are absent [ ] . asthma and allergies are also seen to be due to the absence of protective bacteria, which normally are present to be induce anti-inflammatory regulators [ , ] . in these studies, hanski and colleagues [ ] explicitly link environmental health, microbial diversity, and human health. indeed, a new field of dysbiosis is now emerging, including not only infection, but also other conditions that may be caused by deficient or aberrant microbiomes. here, the normal symbiotic relationships that maintain physiological or developmental continuity, have been abrogated. in recent years, science has traced these networks from associations to specific causal changes that can be tested. while many of these experiments have been performed in mice, the same pathways are known to be present in humans. these non-contagious diseases include asthma and allergy [ ] , kwashiorkor [ , ] , obesity [ , ] , diabetes [ ] , ulcerative colitis [ ] , depression [ , ] , and parkinson's disease [ , ] . these "microbial deficiency diseases," constitute a new and possibly important category of illness. this is not to say that dysbiosis is the only cause of these conditions, but that it is a public health concern that should be investigated. an important conceptual barrier was recently crossed when the gut microbiomes of pregnant mice were demonstrated to be critical for the intrauterine development of the fetus. short-chain fatty acids (such as butyrate and propionate) are products of the gut microbiome's digestion of cellulose. as no mammalian genome contains genes for cellulose digestion, the breakdown of plant material is almost totally accomplished by enzymes produced by microbes. kimura and colleagues [ ] demonstrated that propionic acid, derived from the breakdown of fiber by maternal gut microbes, was critical for the normal development of the insulin-producing pancreatic beta cells, the sympathetic neurons that project to the heart, and the gut enteroendocrine cells. without the microbe-derived propionic acid, the adult offspring developed a metabolic syndrome characterized by glucose intolerance, obesity, and insulin resistance. since diet can control the prevalence of microbes, the holobiont model can explain the mechanism whereby eating low-fiber, high-calorie diets during pregnancy predisposes offspring to have metabolic syndrome later in life [ ] . to understand the importance of a symbiotic approach to public health, one has to first appreciate the new biological notion of the human body. each of us is a functional entity that includes our zygote-derived cells as well as hundreds of species of microbes. the body is both an organism and a biome containing several ecosystems [ , , ] . once the amnion breaks, and the fetus passes through the birth canal, the newborn becomes colonized by their mother's bacteria [ ] . furthermore, mothers' milk contains a special set of nutrients to promote the survival and growth of those bacteria that are important for symbiosis [ ] [ ] [ ] . these symbiotic bacteria will produce short-chain fatty acids and sphingolipids necessary for intestinal peristalsis and homeostasis, peptidoglycans necessary for normal neuron function, lipopolysaccharides necessary for the actions of the immune system, the tripeptides necessary for cardiac physiology, and the digestive enzymes necessary to metabolize plants [ ] . remarkably, a third of the small metabolites in the blood are produced or induced by bacteria [ ] . nearly all of our peripheral serotonin is induced by gut microbes, where it regulates the maturation of the enteric nervous system and regulates peristalsis [ , ] . even more remarkable is that such critical symbioses are not only present within humans. rather, the development of most organisms appears to be predicated on interactions between hosts and their symbionts. as mentioned in the above section , without microbial symbionts, mice do not form their gut capillaries, their gut-associated lymphoid tissues, their t-and b-cell repertoires, or the proper synaptic connections in their guts and brains. moreover, no vertebrate contains genes that make the enzymes necessary for digesting plant material such as cellulose, hemicellulose, and pectins [ ] . these genes are provided by symbiotic microbes in our guts. in mammalian evolution, the entire family of ruminants is made evolutionarily possible by the ability of gut bacteria (acquired at birth) to build the rumen of the stomach and then to ferment grass and grains [ ] [ ] [ ] [ ] . thus, symbiosis is a paradigm-changing idea in physiology. we are no longer seen as being "individuals." we are holobionts, and our anatomy, development, immunity, and physiology are intimately linked with that of our microbial components. the importance of the holobiont perspective for public health is that absences of particular microbes may cause dysbioses throughout a population. martin blaser and colleagues [ , ] have warned that we may need particular microbes for particular functions, and that our obsession with exterminating microbes may be inadvertently killing those bacteria that we need to survive. their data indicate that microbes that used to be prevalent (those, for instance, in barnyards and horse stalls) are becoming rarer. if these microbes are necessary for normal organ, immune, or cognitive development, we will be impaired. rhesus macaques that are bottle-fed, rather than breast-fed, acquire a different population of gut microbes, and this population is not as adequate to develop a functioning immune system that can repel opportunistic infections [ ] . in zebrafish, a relatively rare species of bacteria is essential for permitting the expansion of insulin-producing pancreatic cells, thereby protecting these fish against diabetes [ ] . this absence of specific bacteria (or their genes) may be crucially important for explaining the increases in allergies and asthma since world war i, and especially, after world war ii. throughout human history, we had constant exposure to barnyard microbes. it was only in the th century that they were displaced. the barnyard was not just an attribute of farms. the nineteenth century city, according to raulff [ ] (p. ) "consisted of rows and rows of urban stables." mid th c. boston had some stables, each having around eight horses. in contemporary america, only % of amish children, whose homes are often adjacent to their barns, have allergy and asthma. about % of the genetically similar hutterites, whose farms are not located close to their homes, have allergies, roughly the same as the american population in general [ ] . similarly, finnish studies have shown that proximity to the barn is a factor in combatting allergies. a recent study shows that children living in urban homes with barnyard bacteria have much less asthma and allergies than those children living in urban homes with urban bacteria [ ] . indeed, two of the bacterial types found in the "rural" homes and missing in "urban" homes were brevibacterium and ruminococaceae, bacteria found in horses and cattle. although the severity of microbiome diversity loss might be most discernable in urban populations [ ] , the importance of soil microbiomes for the maintenance of healthy human intestinal microbiomes has recently been emphasized in studies [ ] showing that even in rural areas, farming techniques have severely reduced soil microbiome biodiversity. bacterial displacement due to urban living and the absence of animals is only one of the ways that anthropogenic microbial displacement can affect public health. caesarian sections disrupt one of the pathways of maternal kinship. babies receive a protective set of symbiotic microbes from mothers when they pass through the birth canal. in caesarean sections, this transmission is abrogated. babies delivered by c-section were found to be deprived of those microbes that otherwise colonize the infant gut. instead, there were the hospital dwelling microbes that included a substantial number of opportunistic pathogens. moreover, a substantial set of these microbes contained genes associated with antimicrobial resistance [ ] . not only were the species of microbes different, but so were their functions. the caesarean-delivered infants had less ability to mount immune responses to common antigens [ ] . this may have strong public health implications concerning elective c-sections. the microbes of our gut are critical for "basic neurogenerative processes such as the formation of the blood-brain barrier, myelination, neurogenesis, and microglia maturation." [ ] . if this is indeed true, then could microbes also be critical for mental health? what if, in addition to protection against allergies and asthma, bacteria were protecting us against mental health conditions such as schizophrenia, bipolar disease, and autism? several studies now indicate that gut microbes appear to be critical for normal brain development and behaviors in mice [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] . first, mice born from germ-free mothers and who are themselves without microbes have a syndrome that includes obsessive self-grooming and asocial behavior [ ] . this behavior is possibly due to the failure of oxytocin-releasing signals from the vagus nerve, and it can be reversed by providing the germ-free mice with lactobacillus reuteri or with microbes from normal mice or from normal humans [ , ] . germ-free mice given microbes from autistic humans do not show improvement of their symptoms. although human cognitive and affective behaviors cannot be extrapolated for those of mice, a pilot uncontrolled fecal transplant study in humans showed that after two years, the acquisition of normal bowel microbes by autism patients significantly improved their symptoms: from % severe autism to % severe autism [ ] . similar studies in mice and humans have shown that the gut microbiome may be critical in protecting humans from depression [ , [ ] [ ] [ ] . there is therefore reason to test the hypothesis that removal or depletion of normal environmental microbes may be responsible for the increasing percentage of the population diagnosed with cognitive dysfunction. while studies of the effects of microbes on mental health lag behind those studies of microbial involvement in physical health, the relationship of symbiotic microbes to cognitive and affective health and disorder is an area that cannot be ignored. public health must acknowledge that we are not monogenomic individuals. we are consortia of dozens of species per person, integrated together in a complex and dynamically changing network that forms who we are at any given moment. this network is altered by the food we eat, by the food our mother ate, the toxins and medications we are exposed to, and by our daily interactions with other holobionts. our health depends upon other species, making the "one health" perspective more than metaphor. the symbiotic networks of the human holobiont are enmeshed in larger symbiotic networks that sustain the planet. public health would be severely affected if any of the many life support systems on which we depend-including pollinators, soils, and bacteria-fail. indeed, symbiosis is the signature of life on earth. the nitrogen in our soil and atmosphere is made available for protein synthesis by symbioses between rhizobacteria and legumes. the interactions of plant roots and mycorrhizal fungi are critical for plant growth, while endophytic fungi are often necessary to protect the plants against dessication [ ] [ ] [ ] . the coral reef ecosystem is dependent on the symbiosis of algae and the ectoderm of corals, while the marine seagrass ecosystems are sustained by symbioses involving clams and their bacteria. reef-building corals survive through the photosynthesis of their algal symbiont, which enters into the ectoderm of its host and transports over % of its photosynthetically derived carbon compounds to the host cells [ ] . however, these symbioses, the very symbioses that define the planet, are at risk. these are the analogues of the microbial displacement and extinction that affect human health. although public health is mainly concerned about "human" public health, one readily finds that we cannot separate ourselves from our ecosystems socially, politically, economically, or biologically. coral reefs, for instance, are thought to support million people across nations and contribute nearly a trillion dollars to the world's economy [ ] . the great barrier reef, alone, brings billion dollars annually to australian commerce. healthy coral reefs absorb over % of a wave's energy, thus protecting the shoreline, preventing nearly a hundred million dollars' worth of flood damage each year. however, the coral that form the critical structure of these reefs must be seen as a holobiont that exists only in a fragile symbiosis between the coral animal and single-celled zooxanthellae algae. the coral animal provides a sunlit, safe, and nutrient-containing environment for the algae; and the algae, living within the animal cells, provide the coral with the sugars it produces by photosynthesis. the coral holobiont can survive only when its symbionts are present to provide the food resources [ , ] . under stress conditions such as high temperatures, the symbionts are expelled from the corals, leaving the corals "bleached" and undernourished. these corals usually die. as a result of global warming, massive bleaching events and coral die-offs have occurred [ , ] . we are writing this essay not only in the coronavirus pandemic of but in the great barrier reef bleaching event of [ ] . over half the corals in the great barrier reef have perished, and some entire reefs have collapsed. the mechanisms for the expulsion of the algal symbiont from its coral host are under investigation, and it appears to be a mutual breakdown of the symbiotic relationship [ ] . one hypothesis is that heat disrupts the photosynthetic apparatus of the algae, causing them to produce dangerous hydrogen peroxide radicals. the coral cells defend themselves by expelling the algae or destroying them. another hypothesis is that warmer temperatures permit algae to get the organic nitrogen that allows them to metabolize their sugars without needing the coral, thereby forcing the coral to rely on their own meager carbon reserves [ , ] . in addition to anthropogenic heating, humans are also affecting symbiosis through domestication. mycorrhizal symbiosis is critical to plant nutrition and, therefore, a necessity for sustainable agriculture. however, artificial fertilization of soil diminishes the mycorrhizal fungi and root symbiosis. martin-robles and colleagues [ ] have linked the loss of symbiotic colonization with plant domestication. indeed, failure to colonize is common, making domesticated strains addicted to artificial fertilization [ , ] . moreover, the lack of myccorhizal fungus may make the domesticated plants more susceptible to pathogenic fungi [ ] . we are integrated into these webs, where our nutrition, oxygen, and environmental temperature depend on global symbioses, and microbes are at the base of each of them. the anthropocene has put these relationships in peril. as deborah bird rose [ ] wrote, "relationships unravel, mutualities falter, dependence becomes a peril rather than a blessing, and whole worlds of knowledge and practice diminish. we are looking at worlds of loss that are much greater than the species extinction numbers suggest." the vectors of disease are following the sun and following airplane and sea lanes. wastewater, tourism, and trade are circulating microorganisms around the world in a scale never before seen [ ] . moreover, global warming is predicted to introduce new microbes from melting permafrost as well as bringing many insect-borne diseases (dengue fever, malaria, lyme disease etc.) into new regions [ ] . here, the vector spreads a pre-existing symbiont. these will undoubtedly cause major public health concerns. however, another mechanism of disease can be predicted: when organisms reach new lands, they are capable of finding new symbiotic partners. there is a new anthropogenic mingling going on. as an example, consider the red turpentine beetle, dendroctonus valens, a minor pest species that routinely infects pine trees that have been damaged by weather or fire. like other bark beetles, it is covered by fungi. these fungi digest tree bark, allowing the beetle to have a home and mate. the fungus associated with d. valens is usually leptographium procerum. however, this beetle was introduced from the pacific northwest of america to shanxi province of china in the s. in china, it met other fungi, which are much more potent at digesting wood than the american fungi [ , ] . these newly acquired fungi can degrade a major host defensive chemical [ ] . as a result, over ten million pine trees have been killed by this fungus in china. american officials are worried about a "boomerang effect" [ ] . the version of the beetle with its chinese fungi may have been re-imported into the usa. however, the public health services of the various states that might be affected claim they do not have the revenue to test whether this is so. organisms are holobionts, and public health must recognize the webs of symbioses uniting different species of organisms into a collective "individual" and uniting these different individual teams into complex ecosystems. symbiosis takes two major forms-mutualism (cooperative) and parasitism (pathogenic). the emergence of antibiotic drug resistance is the anthropocene effect on parasitic symbiosis. just as anthropogenic changes in the environment have changed the populations of microbes involved in mutualistic interactions with humans, so other anthropogenic changes have increased the prevalence and virulence of parasitic microbes. until the early century, the leading cause of death, world over, was infectious disease. crucial to turning this around were sanitation of water, and the discovery of antibiotics. since their discovery in the s, antibiotics have become the key tool against infections caused by microbes, used across different forms of medicine. by this definition, microbes are understood as pathogenic and parasitic, dangerous, dirty, and damaging the host that they reside in. bodies are seen to be 'at war' against harmful outside invaders and entire disciplines have been hinged on this notion-immunology, clinical medicine, and public health just to mention a few. antibiotics have been the miracle weapon that have been used to tackle the looming threats of bacteria and have been said to have developed contemporary medicine to be the success story that it is today [ ] . antibiotics have magnificent power to alleviate symptoms and ensure sterile conditions; they play central roles in basic surgeries, cancer, cesarean birth, and in treating basic infections. they are prescribed against infections by doctors, nurses, pharmacists, dentists, and traditional healers, depending on the contexts, all across the world. there are very few communities left that have not incorporated the use of antibiotics into their basic methods of healing, and research on those communities is tapping to their 'untouched microbiomes' microbiome as an 'oasis' [ ] [ ] [ ] [ ] . literature about antibiotic prescription describes how requests for antibiotics reside on all sides of the patient-health care practitioner dyad: patients say that health care practitioners hand out antibiotics liberally and health care practitioners argue that patients demand them [ ] [ ] [ ] . in addition, antibiotics are bought over the counter from pharmacies, and informal markets [ ] . antibiotic use is a matter of concern as excessive or unregulated use of antibiotics is connected to the development of drug resistance and while there are few new antibiotics in the pipeline, there is a need to ensure the utility of existing ones [ , ] . antibiotic use patterns offer insights into how central antibiotics are to public health, as well as the specific practices and contexts that rely on the use of antibiotics. understanding these dynamics also illuminates the effects of pathogenic thinking as well as the myriad ways in which reliance on antibiotics would need to change in order to make space for a holobiont practice of public health. global statistics about antibiotic use show differences between countries that often follow the guidelines of health system efficiency and general national income. since the s, antibiotic use in low-and middle-income countries has considerably increased, while in high-income countries, particularly with those that rely on public rather than private health care, antibiotic use has been reduced. india, pakistan and china are among those countries where use has increased most [ ] , while data is unavailable in most african countries [ , ] . that said, despite the reduction in the high-income countries, antibiotic use in many european countries and the us is still considerably higher per capita than across many african nations [ , ] . the increase of antibiotic use in low-income countries underscores the utility of antibiotics within lagging health care systems and/or in places where people cannot afford health care. especially in countries where health care access is precarious due to lack of access, poverty, or poorly operating health systems, antibiotics have come to play a central role in how short-term health goals are achieved. for example, work by denyer willis and chandler [ ] shows how antibiotics function as a 'quick fix' for well-being. this fix operates on multiple domains: to ensure productivity of humans, animals and crops; hygiene in settings of minimized resources marked by lack of infrastructures; and good health in landscapes scarred by political and economic violence. in short, antibiotic use has come to stand for development and well-being. while use of antibiotics has played a crucial role in helping to increase life expectancy, implementing invasive surgical procedures, and stand in for health care systems where they are otherwise unavailable, the use of antibiotics has accelerated embodied and ecological havoc. a narrow characterization of microbes solely as parasitic and pathogenic enemies rather than as needed and helpful partners contributes to excessive use of antibiotics for humans and animals, where microbes 'refuse' to remain contained in bodies but shift their form by evolving resistance to antibiotics. the heroic narrative of antibiotics is beginning to crumble as microbes push back. mass scale attempts to eradicate bacteria with antibiotics in humans and animals has led to increase of antimicrobial resistance (amr), making it a quintessential anthropocene problem. indeed, the mass scale of antibiotic production, beginning in the s, "quickly became infrastructural to the production of many other things at scale: more health, more meat, more fruit, more surgery, less death, more fertility, in everything from in vitro embryos cultured in antibiotics to fish farming. the scale of production is also the scale of resistance" [ ] . the higher-than-expected levels of amr put western medicine in its current form-where antibiotics play central roles-at risk. with antimicrobial resistance, global health literature continues to frame microbes as a threat, now an incurable threat. the most comprehensive report about amr and its future impacts, the so-called o'neill report commissioned by the uk government and the wellcome trust, indicated that million people will die due to complications associated with amr [ ] . this report has evoked a flurry of research efforts, systemic interventions, stewardship programmes, and funding to tackle amr. health risks for humans have been extensively documented, with resistance spreading owing to both excessive use of antibiotics for human consumption and the use of antibiotics as part of animal feeding and in husbandry. a key route by which amr spreads is via environmental bacteria that serve as vectors for the resistant genes-lateral gene transfer-which is seen to become a problem when otherwise benign environmental bacteria contribute to the spread of resistance in pathogens [ , , ] . robinson et al. state that this otherwise 'natural' quality of environmental bacteria is exacerbated, for example, by the influx of antibiotic residues from human and animal faeces, and run-offs from hospitals and pharmaceutical manufacturing [ , ] . a global comparison of socio-economic determinants correlated with amr prevalence offers insights into the crucial roles that developmental and social inequalities play in anthropocene ecology. factors predicting high amr rates are not antibiotic consumption, but, rather, differential access to sanitation, education, and public investment in health care services, as well as the level of corruption in society [ ] . the focus, therefore, cannot be simply on clinical bodies, but must broaden to encompass environments including animals and infrastructures on the one hand, and social practices and power on the other. we posit that the notion of plantationocene captures this complexity that transcends the human-more-than-human bodily boundary while taking power structures into consideration. as defined above, the plantationocene constitutes the coercive labor structures and extractive and hierarchical management of planetary resources to feed an ever-growing population [ , ] . the plantationocene acts here both an analytical and a descriptive term. analytically, plantationocene points to transnational circulations of goods, domination and dominion of people over other people and people over nature, hegemonic colonial legacies, systematisation of farming. haraway et al. [ ] point to the historical origins of the term and how relocations of the substances of living and dying around the earth as a necessary prerequisite to their extraction. the logic of the plantation system makes it more efficient to destroy the local labor and import labor from elsewhere. the plantation system is built on the relocation and control of any generative unit, whether plant, animal, microbe, or person [ ] . indeed, plantations were the result of one of the most catastrophic public health events in world history-the columbia exchange. a major part of this exchange resulted in the elimination of a majority (perhaps %) of indigenous american people by the microbes-rubeola, variola, influenza, rubulavirus, rickettsia, salmonella and bordetella-brought across the atlantic ocean by the european settlers. the great migration of people and crops took place to bring workers to areas whose native populations had perished, especially in the caribbean, where the death rate of indigenous people was probably close to % [ ] [ ] [ ] . intensive labour was needed to produce crops in north and south america, and the 'workers' at plantations were slaves shipped from west and central africa-now sites that have the least infrastructure to surveil and control amr, but have the most troubling evidence of amr prevalence [ , ] . these were also sites of resource extraction as well as subjected to structural adjustments in the s by the world trade organisation to privatize health care and social welfare, resulting in poor health care and sanitation infrastructures and overall poverty that now are known to be key factors for the development of amr. the industrial agriculture of the plantationocene may also contribute to the spread of drug resistant microbes. the recent increase in resistant fungicides such as candida auris, that has caused tremendous concern among health practitioners and ecologists alike, is a resistant yeast that has contaminated entire hospitals [ , ] . its spread has environmental vectors-resistance has developed in connection to the use of fungicides in monocropping [ ] . environmental and agricultural practices are thus directly connected to public health concerns. amr with plantationocene underscores that public health needs to re-think its relationships with bacteria and antibiotics-it cannot bracket out environmental extraction, socio-economic injustices and the on-going need for health systems strengthening as factors that create the conditions for why excessive antibiotics are used that lead to antimicrobial resistance. amr by this definition is not an exemplary threat by microbes as is framed in global public health but should be seen as a result of the modernist, eradication approach towards microbes that requires rethinking. health is a negotiation between microbes and hosts. holobiont public health would do well to recognize both the parasitic and the mutualistic branches of symbiosis [ ] it would also recognize the two major changes in our scientific knowledge of microbial evolution that have occurred in this century: ( ) organisms are holobionts composed of several species, wherein microbes help maintain healthy physiology and resilience; and ( ) bacteria can pass genes through horizontal genetic transmission, thereby facilitating the rapid spread of antibiotic resistance through numerous bacterial species. symbionts must be seen as partners and respected as agents with their own agendas. three recent examples of holobiont "management" for public health should be mentioned in this regard. the first concerns the public health against mosquito-transmitted diseases such as dengue, zika, and chikungunya by using wolbachia bacterium to infect aedes egypti mosquitos. wolbachia infects numerous insects, but not these species of mosquitos. however, wolbachia can become a symbiont in these insects, preventing the acquisition or replication of viruses inside their cells. scientists have been able to get wolbachia to grow inside aedes cells, and wolbachia-infected mosquitoes have been released into the wild. where this has happened, there has been significant drops (up to %) in reported cases of the vector-transmitted diseases [ ] [ ] [ ] . the second holobiont-informed type of public health involves seeking alternatives to antibiotics and partnering with microbes capable of keeping pathogens in check. if symbionts help protect hosts from pathogenic bacterial infections, then symbiotic microbes would be a good place to start looking for new antibiotics. this is especially true of antibiotics for gram-negative bacteria. the antibiotics currently in use were developed in the s, and several bacterial species have successfully been evolving resistance to them. certain nematode worms are susceptible to the same types of gram-negative bacteria as humans, so imai and colleagues [ ] sought out the antibiotics made by the symbiotic strains of bacteria found in the nematode guts. by screening chemicals made by these symbionts, they have isolated darobactin, a modified and crosslinked -amino acid peptide. this antibiotic acts by disrupting the cell envelope of the gram-positive pathogens and is largely non-effective in destroying human gut commensals. the experiments further show that this new antibiotic is effective at protecting infected mice given potentially lethal infections of gram-negative bacteria. the third approach recognizes the importance of microbes to the life cycles of parasites and seeks to kill the parasite by killing its symbionts. this approach has worked in eliminating schistosoma mansoni, a filariasis worm that has become resistant to the drugs traditionally used to kill these parasites. a newer treatment strategy has been to use antibiotics (such as doxycyline) against its symbiotic bacteria [ , ] . once the antibiotic destroys the symbiont, the worms' cells undergo apoptosis and the worms die [ ] . a similar strategy is being considered to eradicate the plague locusts that are now devastating east africa. here, a locust-specific fungus might be sprayed on the juvenile locusts as they develop their wings. this fungus would grow inside the maturing insect and consume it from within [ ] . we need to be in symbiosis with bacteria on a social, as well as on a corporal level. like the body, we need to be able to distinguish mutualistic from pathogenic microbes and treat them differently. humanity has been given notice. a paper by the alliance of world scientists [ ] "puts humanity on notice that the impact of climate change will depend heavily on the responses of microorganisms which are essential for achieving an environmentally sustainable future." public health must take note that we humans are never independent of nature and, therefore, must be expanded to preserve environmental health as well as human and animal health. resilience to perturbations is increased by plasticity and the inputs of symbiotic microbes. each human is a biome of many ecosystems. asthma, allergies, and amrs must not be considered the "revenge of nature." rather they are expected consequences of lower resilience to perturbations. public health must see the life on this planet as biology now sees it-as a rich mixture of cooperative and antagonistic interactions, with our bodies in dynamic relations with its hundreds of microbial partners. author contributions: each author contributed to both the planning and the writing of this paper. all authors have read and agreed to the published version of the manuscript. funding: sgf is funded by a swarthmore college faculty research grant. ss is funded by academy of finland, grant number . microbe hunters; hartcourt brace pasterurization of france vaccines through centuries: major cornerstones of global health. front life expectancy in france the technological society missing microbes: how killing bacteria creates modern plagues three dialogues on knowledge we have never been modern the death of 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ebola: the opportunities for shared benefits date: - - journal: j agric environ ethics doi: . /s - - - sha: doc_id: cord_uid: s gw k the ebola virus outbreak in west africa, as of writing, is declining in reported human cases and mortalities. the resulting devastation caused highlights how health systems, in particular in west africa, and in terms of global pandemic planning, are ill prepared to react to zoonotic pathogens. in this paper we propose one health as a strategy to prevent zoonotic outbreaks as a shared goal: that human and great ape vaccine trials could benefit both species. only recently have two phase / ebola human vaccine trials been started in west africa. this paper argues for a conceptual change in pandemic preparedness. we first discuss the ethics of one health. next, we focus on the current ebola outbreak and defines its victims. third, we present the notion of a ‘shared benefit’ approach, grounded in one health, and argue for the vaccination of wild apes in order to protect both apes and humans. we believe that a creation of such inter-species immunity is an exemplar of one health, and that it is worth pursuing as a coextensive public health approach. ebola virus has devastated parts of west africa, and has caused alarm worldwide. it is one of a number of notable zoonotic emergent infectious diseases (zeid), also including influenza, coronaviruses like middle east respiratory syndrome (mers), and the now pandemic human immunodeficiency virus (hiv). the majority of all eids are caused by zoonoses ; and most of these are pathogens of wildlife origin that become endemic in localised non-human animal and human populations (jones ) . these pathogens are emerging at an alarming rate, reflecting changes in local topologies and the global climate, triggered by human and animal causative and adaptive activities (epstein ) . ebola is endemic to central africa, and is normally dormant in still unknown reservoirs. periodically however, it infects local human populations, causing extensive mortalities but then fading out before widespread contagion (hayden ; marzi and feldmann ; macneil and rollin ) . the ongoing outbreak in west africa surpasses all previous occasions, although at time of this writing, the endemic appears to be receded (who ebola response team ) . many have been dismayed by the global efforts to curtail the epidemic, questioning international resolve to respond timely and effectively (mitman ; spencer ) . in particular, many have been critical of the systematic neglect of public health infrastructure, and have identified strengthening health systems as the long term solution to the disease (dawson ; farmer ; gates ; rid and emanuel ) . the measures used during this outbreak are focused on human communities, and includes clinical case management (that to date lacks any curative treatment), quarantine and isolation, surveillance and contact tracing, a rapid and reliable laboratory service, safe and dignified burials, and social education (dawson ; macneil and rollin ; marzi and feldmann ) . critics have much to say about the importance of infrastructure and basic supplies needed, but less has been said about the limitations of ebola containment measures. although these previously worked well within geographically isolated communities where ebola periodically emerged, they were less likely to do so in a sustained and widespread outbreak. in light of the current catastrophe, it now compels us to consider also the limitations of traditional public health measures during an epidemic of this magnitude, which although they may bring an acute situation under control eventually, are challenging to enforce, strain medical and social networks, and provide limited prevention and no cure. indeed, although these measures have brought the emergency to its current abating state, it took a great deal of time and vast efforts, many still died, and infection resurgence is a possibility. the importance of biomedical countermeasures, such as vaccines, therefore cannot be understated. in this respect, it has been resolved that failures in advanced drug development and production must be tackled (who ) , especially the political and economic barriers that hamper development and deployment in places such as west africa, and which further emphasise the neglect of certain transmissible diseases in that region (marzi and feldmann ) . the current perspectives to zoonotic risks and pandemic planning have changed little despite the warnings from the 'swine flu' pandemic of that the opportunities for expedient vaccine production and sustainable clinical access still seem someway off (gates ) . our particular concern, however, is that while the ethical debate is being dominated by global human threats, other considerations about endemic zoonoses are being overlooked. using ebola as a case study, we apply one health (oh) as an ethical framework to make the case for strategic changes. in particular, the debate about vaccines plausibly could be extended to the concurrent need in primate populations. this paper therefore proposes the possibility of shared immunity between species that are equally affected by ebola. our proposal for a novel approach to vaccination that protects both human communities and the fauna they interact with and often depend upon is speculative, as technical issues are far from resolved. however, we have two further intentions: firstly, to highlight the oh in general, prevention and then containment of highly pathogenic eids is about slowing and limiting the contagion, while often treating patients to the degree possible and who are likely to die, thus allowing the existing infrastructure to operationalize and then keep up. traditional public health methods of infectious disease control are known to work up to a point, depending on various factors such as the pathogen, victim and context. in particular, these methods rely to a large degree on the trust of the populations effected to follow non-pharmaceutical precautions under conditions of immensurable suffering and burdens, and the dedication, training and supplies made available to health care and other workers who sustain the infrastructure (such as, in the ebola case, the highly risky and stressful job of digging and filling graves). confidence in these may have become complacent (putting aside the question of political negligence), as it was only a matter of time before ebola would befall upon a highly populated city for the first time. ''ebola emerged nearly four decades ago. why are clinicians still empty-handed, with no vaccines and no cure? because ebola has historically been confined to poor african nations. the r&d incentive is virtually non-existent. a profit-driven industry does not invest in products for markets that cannot pay'' (chan ) . these failings have become, for some, symbolic of the abject failures of a global system which does not allow new possibilities for pandemic planning, such as more effective and urgent vaccine production (capps and lysaght ) . that ebola is a neglected tropical disease cannot be disputed, meaning that it has failed to attract significant interest for deployment of pharmaceutical interventions (until its full pandemic potential came to light in the current outbreak) (macneil and rollin ). so far, local responses fall back on traditional public health measures; these measures do little to benefit non-human interests, as victims or by finding mutual solutions. we propose that a different approach to pandemic prevention should invest in such technologies as vaccines, but do so using a broad ecological scope. we use primate (clade haplorhini) to identify the non-human apes (hominidae) that are susceptible to the ebola virus; our analysis will proceed to discuss the great apes (genus gorilla and pan), as more is known about the effects of the virus on them as highly sentient and endangered species. initiative as a source of alternatives to pandemic planning, so that, secondly, in the spirit of oh collaboration, we can encourage further and broaden the ethical debate. the paper unpacks in the following way: first, we explain the ethics of oh as an approach that recognises an ecological perspective. second, we define and expand upon the victims of the ebola epidemic so as to consider a new oh-grounded agenda. third, we articulate a possible preventive measure to prevent ebola in both human and animal populations. we argue that, along with efforts to test ebola vaccines in humans, existing vaccines that have been proven safe and efficacious in primates should already be deployed in order to protect both species. our proposal supports the conjecture that focusing on broadly ecological factors, and understanding and reacting to the natural ecology of zoonoses, is central to future zeid planning . one health (oh) has come to signify the interdisciplinary effort to optimize the health of humans, non-human animals, and their ecosystems. as an approach to biomedical enquiry, it has been adopted as a broad heuristic for evidence-based policy involving the usual suspects from public health, as well as veterinarians, animal and plant biologists, ecologists, and environmental scientists (scoones ; leach and scoones ) ; and thereby, it has become a stimulus for collaborative research. thus, its trans-disciplinarily-across multiple disciplines, encouraging de-siloing of sectors, and engagement with partisan stakeholders-creates change by identifying and solving real-world ecological problems. it is thus an extensive ecological perspective to that of public health. however, there are those who have been critical of the oh agenda because, like some existing study or practice lenses, it excludes the humanities and social sciences (lapinski et al. ) , and that, in part, obstructs the development of an inclusive bioethics framework (thompson and list ) . while the first is largely an empirical point, and we can point to anthropologists, among others, expressing solutions, but perhaps being less heard, in respect to ebola (aaa ); the latter observation indicates oh's lack of a philosophical grounding. in fact, oh has no origins in any particular ethical theory. one explanation for this is that normative enquiries are outside of the purview of oh. the collaborative model, therefore, is not about a distinctive oh ethics per se, but an attempt to integrate ecological perspectives on the same terms as public health activism; to probe conventional wisdom to find innovative solutions. this is perhaps a practical consideration because oh otherwise would likely lose political traction under anything more concretely conceptual. the oh goal is to assemble a comprehensive set of data across a broad spectrum of expertise, and to thereby provide solutions that are of benefit to human wellbeing within ecological settings. most recently, this idea is being framed as effectiveness gains through dynamic cooperation in environmental contexts, and has the effect of raising environmental concerns on par with concurrent efforts in public health such as in disease surveillance and animal management. this might be enough to create a vision of oh ethics: van rensselaer potter, in his earliest definition of bioethics, talked about a system of human survival that included environmental, or ecological ethics (potter ). this could easily capture the idea of oh as broadening public health into diverse fields. potter, a pioneer in challenging parochial and non-secular ideas shaping the human condition, noted a schism between the medical-science domains and humanistic ethics, and that both were distanced from environmental ethics. the ethics of oh, therefore, may just be signalling the resurgence of bioethics as a unified endeavour (thompson and list ) , allowing for reflective and critical engagement with current pandemic measures, which up to now gave little credence to solutions outside the scope of public health ethics. a deeper appreciation of secular bioethics, however, also points to the intrinsic interests beyond those of human beings. in the developing oh literature, it is more commonly acknowledged that human beings are part of and dependent upon the biosphere. one way oh has developed is in a perspective that a 'healthy' environment entails healthy animals along with healthy people. it is not 'us versus them', then, but a problem of shared risk that is something concrete to act on, thus providing opportunities to maintain healthy or rescue unhealthy ecosystems (rabinowitz et al. ) . however, in practice, reactions to these risks, and solutions to pathogens, still prioritise human interests, because there is no fundamental sense in which non-human animals, or the environment, matter morally. sure, while oh in this sense creates the grounds for humans to express compassion towards animals and ecosystems and to engage in novel approaches to health problems, overall it often achieves the same goals of prevention and response so far already installed in public health; so oh, in this sense, adds nothing to the ethical debate except by broadening the factors considered in any human cost-benefit analysis. the difference oh makes is in engaging with alternatives: it questions public health ideas entrenched as the only way to solve such problems, and indicates the dangers of the unreflective or blinkered view (leach and scoones ) . its effectiveness in ethical discourse, much like the collaborative idea, is that it asks questions about ecological benefits without overstepping public health priorities. finally, there is the sense in which oh has an enabling effect in respect to grounding an ethical theory in environmental issues. what that theory is, however, is contested. in this paper, therefore, we will sketch the idea that oh ethics ought to contain two elements: ( ) a focus on the inclusive and shared determinants of health; and ( ) a unifying theory. by spelling out these elements better, one is able to assess those projects that profess to be oh; and this will be essential in judging our shared immunity proposal. health is often understood as being normative: implying something good or desirable. this might be applicable from an internal view (being healthy), or an external one, such as the view from public health that concerns community (that is, conditions for being healthy). an 'unhealthy' state can be explained by a pathogen or other kind of destabilising event that impacts or creeps into a biological system, resulting in an altered, often unwanted and endured state. this might be the presence of a virus in an individual, or even the conditions (opportunities and barriers) of healthy living. public health often takes a similar focus, aiming to create healthy circumstances and conditions for people by focussing on the determinants of health. in this respect, oh uses health as an inclusive determinant, such that it includes actions that are broad in orientation and scope, so that health activism ought not be limited to human agents. oh is therefore an investigation of the scientific, social, economic and ecological determinants of human, non-human and ecosystem health, but also a 'shared benefit' approach. our use of 'shared' points to ethical consistency; that actions that affect a broad spectrum of agents should be fairly applied. just as racism is paradoxical in human societies, some exclusionary actions between human beings and non-human animals might be similarly judged as speciesistic. this echoes ideas of equality, and the interests of minorities or the vulnerable being protected against parochial or vested interests. it also befits an examination of incongruity, need and fairness, and justice-these components of comprehensive doctrines are only knowable through ethical study, and in this respect, we are less confident in setting the oh agenda, for such a task requires far greater elucidation than is possible here. we can, however, offer a basic account of 'benefits' that will begin the conversation in earnest about oh as a unifying theory. human beings act in ways that affect non-human animals and the environment, and this raises the question as to how much we should either change such actions, or, indeed, make efforts to assist in the wellbeing of other species. the basic assumption in public health has been that we should interfere only to the extent that their collective welfare is at stake, because animals' interests are outweighed by human interests . thus, public heath applies welfare conditions for the health of animals, which only occasionally includes ethical considerations, such as the humane culling of disease vectors and hosts. however, without engaging in a lengthy debate about non-human moral status, there is also a condition of interspecies connectedness. in the case of preventing zoonotic pathogens, oh on this reading implores us to study the causes and roots of transmission, counting each being as an equal unit in this biological process. the wider study of biospheres, ecosystems, and social networks achieves this. what is ethically important is that this study is concerned with the health of the ecosystem in its entirety, not solely that of humans. oh, therefore, becomes a study of 'natural' environments, enriching public health with animal and ecological studies, and creates a whole new frame of evidence to better design effective responses. in turn, the emphasis turns to discovering and developing creative ways to recover and maintain healthy ecosystems. these hint at plausible strategies that draw on the humanities and social sciences, which can better comprehend the emergent contingencies beyond statistical confines (neyland ) . but what are the objects, goods, or benefits(and harms) that enable states of heath? one way we might extend ethical concerns to non-human interests is by securing universal goods (capps and lederman ) . these are the kinds of goods that reach beyond the needs of human communities, describing benefits as inclusive across species, and feature broadly in ecosystems and the environment. for example, ecosystems are necessary for life by providing the basic requirements (and even complex determinants of heath, in terms of social and cultural goods), and can therefore create 'unhealthy' lives by becoming unproductive and even toxic. these effects can be observed in stressed and challenged environments when they are misused, exploited and degraded. the ecosystem is, therefore, a foundation of universal goods-goods necessary for the health of multiple species, and these goods are likely shared through interspecies connectedness. primarily, then, universal goods extend terms of reference beyond the restrictions of public health purposes. one set of solutions would emanate from comparative medicine originating in human beings (this is the opposite of current comparative medicine studies where animal models are utilised for human health). human trials and treatments may well be useable in animal populations, benefiting them directly, and in some cases, where a pathogen is eliminated, it might reduce risks for human populations. a second possibility would be adapting biobanks, which, because of the terms of reference in providing public goods, are restricted to furthering human interests only (capps ). this does not make good scientific sense, because there is a welter of data being lost or overlooked simply because of intentional institutional design that arbitrarily excludes other contributions. for example, animal samples may well show up zoonotic risks sooner, or enable the natural history of a pathogen to be understood. a recent proposal to create an ebola biobank would do well to consider extending its remit to include the animals that are the essential links in zeids (hayden ) . these are intriguing possibilities because they also allow real environment information gathering and sharing, and not just the artificial data, for example, from de novo animal experiments (capps and lederman ) . there are, however, going to be more or less hard cases where conflict between public health goals and securing universal goods is more or less likely; and solutions are going to be less amicable between human interests and an ecological perspective. at this level of disagreement, a debate about animal or environmental interests or rights is to be had. but in our paper, we develop this idea of universal goods to give weight to the broadly inclusive and shared determinants that are affecting both humans and animals as victims of ebola. according to oh, it behooves us to consider the opportunities to improve the health of those directly affected by the virus, in the sense that operationalizing public health should be extended to other primates such as chimpanzees and gorillas; related not only in their level of evolutionary sentience, but also as victims of ebola. the current ebola outbreak, which started in a single index case in december , but was not reported as an outbreak until march , is the largest known in history (rio et al. ; yakubu et al. ) . both humans and great apes have been affected. at time of writing, there have been , reported confirmed, probable, and suspected cases in human infections, mainly in guinea, nigeria, liberia, and sierra leone. , confirmed patients have died. in great apes, the effect of ebola is likewise devastating. gorillas and chimpanzees are susceptible to the virus (bermejo et al. ; kaiser ) . ebola has killed roughly one third of the western lowland gorilla population in the past years, which, along with habitat loss and poaching, led the world conservation union to declare it a critically endangered species (walsh et al. ) . three interrelated enquiries interest us as advocates of oh. first, a significant question is 'why now?' (bausch and schwarz ; farmer ) . why only now has the ebola virus, which has previously emerged in isolated regions, become a regional endemic (olival and hayman ; olson et al. )? this question has been asked in the context of other zoonotic diseases, most prominently hiv and its analogous emergence from primates in africa. answers will likely become evident as our understanding of zoonoses encompasses the exponential amount of accumulated knowledge from across disciplines, including the study of the reservoir, host and effected animals, the ecologies they inhabit, and their natural responses to the virus. it is therefore not only a question of what humans might have done differently this time to create the tragedy, but also their ongoing interactions with the environment whence the virus came from. these insights will be significant in developing strategies for potential future ebola outbreaks, and paradigms for other zeids, including possible preventative measures. second, it has been debated as to whether medical interventions for eid should be deployed in animal species. according to one view, we should not interfere with natural systems at all; apes have lived with ebola for years without need for human intervention. yet the state of wild populations today is such that no environment is free from human effects, and therefore such groups must adapt to the 'anthropocene' (hockings et al. ) . in fact, the landscape has changed so significantly that human intervention is perhaps necessary for them to survive at all. although dissent has been voiced against interfering in 'natural systems' and the effectiveness of medical interventions relative to other conservation strategies (ryan and walsh ) , the magnitude and significance of the current ebola outbreak should at least question the premise of non-intervention. intervention, therefore, can be justified because the alternative is decimation across the biosphere, affecting human beings who rely on it, and the animals that live within it. if this can be considered as a universal good, then, we can start to envision medical strategies to protect both human and animal populations. the plausibility of vaccinating other species during significant endemics has been voiced before, often from the conservation angle (marzi and feldmann ; ryan and walsh ) , but never received any serious consideration, as far as we are aware. two reasons for this might be postulated: limited resources are to be used to address human needs, especially at times when endemics or potential pandemics are occurring; and vaccine safety in administering to potentially critically endangered species. recently, a vaccine trial for ebola was carried out on captive chimpanzees to inform future conservation (warfield et al. ) . third, what (at least partially) grounds the need to respond to the queries posed above in respect to the shared risk of zoonoses, is the fact that human beings and primates are equally affected by the virus. therefore, if an ethics of shared benefits is persuasive, then one can start to see how conceptual change is necessary in zeid planning. for example, standard public health policies prioritise human interests, and often, these interests are perceived to collide with and outweigh the conservation of the biosphere. examples would include devastating and often ineffective culling (johansen and penrith ; jenkins et al. ) , or ravaging biodiversity on the basis of 'at-risk-to-human' calculations. oh, however, starts to give rise to different opportunities: for example, developing data storage from veterinary and conservation studies that can benefit humans, and vica versa (capps and lederman ) ; or strategizing to create healthy ecologies that will concurrently present fewer risks to human beings. concomitantly, humans, who often receive better medical care, may serve as 'concurrent research participants' and adaptive public/veterinary health models. the scientific literature to support oh as an approach to coordinate pandemics of zoonotic origin is rapidly accumulating (rabinowitz et al. ), such that it should be gaining traction in pandemic planning. it has, however, yet to feature in the solutions to ebola. oh ought to have some quite significant implications for pandemic planning (against ebola and generally) in various chronological phases. . the natural ecology of the ebola virus. the animal origin of the current epidemic is perplexing. the virus tends to only occasionally emerge in isolated villages, rarely appearing in hospitals and other health facilities (garrett ) . in this regard, the current outbreak is unique. beyond human interference, the ecology of the virus itself undoubtedly plays a key part. there are a number of species that could be implicated as the host, such as bats, other large mammals, or primates; even insects and plant viruses have been implicated in its transmission to human beings (hayden ; monath ) . it is imperative to conduct studies to locate the reservoirs and the plausible transmission routes to human beings and primates (in terms of group-to-group interspecies and cross-species transmission) and other known and unknown species contagions, to explain risks and spillover events. wildlife conservation workers have been tracking ebola in gorilla and chimpanzee populations for some time; but these data rarely reach the attention of public health planners (walsh et al. ). . manage habitat disruption. there is a vast and largely uncharacterized pool of possible zoonotic pathogens, and increasing opportunities for infection caused by disruptive human activities and ecological encounters (morse ). the understanding ecologies of vector-borne pathogens reveals some intriguing events, such as how biodiversity and diverse species networks can buffer, dilute and 'soak up' pathogens (harris and dunn ; keesing et al. ). that is, comparative studies and the reverse data use of human trials to benefit animal populations, such as in veterinary application (yeates ) . an early report from the current outbreak hypothesized that the host was a bat colony living in a local hollowed out tree (saéz et al. ). development of industry, such as mining, can bring people into regular contact with zoonotic reservoirs and hosts (kangbai and koroma ). these industries employ local and international workers who then travel to and from wild territories (allouche ) . anthropocentric activity also disrupts normal animal behaviour, for example, changing fruit bat roosting and foraging ranges so that they move to proximate sites to human dwellings (looi and chua ) . further, evidence suggests that biodiversity is a key element in emergent zoonotic diseases, where, in some cases, there is a reversed correlation: less biodiversity, or even deprived ecologies, create more risks for human zeids spillover events (cardinale et al. ; jones ) . . prevention of zoonotic infections. non-pharmaceutical measures can work well in eid outbreaks, but are only practical considerations once the spillover event has occurred in humans (in other contexts, personal protection equipment might be used as biosafety measures). reactive pharmaceutical measures, such as vaccines, take time to develop to specific pathogens, and then are often hampered by politics and investment, biological limitations, errors, and logistics. prevention, as is central to public health, might therefore be considered key. currently, several types of ebola vaccines have been proven effective and safe in primates, but none has been approved in humans yet (see below). human trials however are ongoing; and several captive chimpanzee trials have been conducted warfield et al. ) . once an ebola vaccine is approved for use in humans, several strategies to increase coverage may be used, such as ensuring that eco-tourists are appropriately vaccinated before visiting at-risk primate populations, and introducing health programmes in mining and refining communities often located in remote areas and near to potential ebola hotspots, such as bat roosts. . monitoring of disease in animals. studies have identified stereotypic behaviours in animals when burdened with zoonotic disease. for example, gorillas faced with endemic ebola reacted in ways that point to a decrease in social cohesion and lower reproductive potential: females were significantly more likely to transfer from breeding groups to non-breeding groups and males were more likely to transfer from groups to solitary-living. in general, there was a decrease in formation of breeding groups. interestingly, during the post-epidemic period, immigration of breeders between groups returned to normal while immigration of non-breeders remained low. observable social dynamics, then, may be used as indicators to detect ebola outbreaks (genton et al. ). this is an example of how animals can act as sentinels for imminent human risk. . animal-to-human transmission. several routes of animal-human transmission of ebola exist, including ingestion of raw infected meat (bats, primates and other animals) , and exposure to hosts and reservoirs through daily life, professions and tourism (köndgen et al. ). these various routes are potentially causing more zeid spillover events. for example, 'bushmeat' is consumed in higher amounts due to population growth in some areas (wolfe et al. ) ; mining is a growing industry in many regions (see below); and local economies rely on the growth of ecotourism. presenting these as local and global issues is challenging: for example, the local population is unlikely to support the prohibition of eating specific species as part of infection control. moreover, to have ethical credence, it would be consistent to address concurrent risks in developed countries, such as reducing intensive farming that also drives zeids. as regional industrial growth is essential for creating sustainable development for all countries, a call to reduce anthropocentric activity in rich wildlife areas in order to meet expedient conservation efforts would likely be rejected because of the local economic losses (and the international desire to visit such areas). nonetheless, efforts should be aimed at education of locals and visitors about the modes of transmission of ebola (muyembe-tamfum et al. ). learning about the local ecology-animal behaviour, biology, anthropology-would point to innovative ways to adapt in order to reduce the risk of transmission. the accumulated knowledge, therefore, raises some intriguing possibilities for the study and feasibility of potential zoonotic control measures; and in particular, using and adapting the 'shared' biosphere as part of the solutions to endemic ebola. however, despite the obvious ecological links to human zeid outbreaks, the interest in devising such possibilities has, until now, had little traction in public health and extant pandemic planning. most pandemic plans mention little about the ecosystem beyond its risk potential and stipulate requirements to devastate the animal populations (culling and the like) as a means to limit future human-to-human transmission. the one health solution to endemic ebola: inter-species immunity vaccination is by far one of the most significant responses to eid in human beings, and in the context of ebola its importance is beyond doubt; since the outbreak was first detected, public health, clinical staff and allied workers struggled against quite immense odds to bring it to the current state. the case for human vaccination speaks for itself. however it should not be understated quite how important it is since the alternative is to fall back on the objective: ''not to dramatically increase the person's chance of survival, it's to contain the spread'' (fjeldsaeter ) . one can only imagine what advantages the early deployment of an effective vaccine would have been. putting aside questions of the economic inequality that provides little incentive for vaccines until worst case scenarios prevail (capps and lysaght ; dawson ; farmer ) , the current upscaling in research to find a vaccine for ebola illustrates the standard phased approach to innovation: invention, animal experiments, trials in humans before large scale production and delivery. as with human beings, the obvious advantage to animals affected by the disease, such as great apes, is immunity from the disease (and relationally, although not always the case, such as with endangered species, is exclusion from culling measures), and prevention of cross infection (walsh et al. ). the obvious benefit is also in terms of conservation. specifically the case of highly endangered gorillas (and other susceptible animals on wwf lists) is extremely significant (ryan and walsh ) . no ebola vaccine has yet to be approved for therapeutic use in human beings. however, ebola vaccine development has been an active field of research for several laboratories worldwide, and candidate vaccines were found some time ago to be safe and efficacious in mice (blaney et al. ) . several human-targeted vaccines have been proven safe and efficacious in trials in primates, including adenovirus type and , human parainfluenza virus type , and vesicular stomatitis virus geisbert and feldmann ; marzi and feldmann ; stanley et al. ). these prospective vaccines, however, raise different concerns, such as safety, price, effectiveness, delivery and side effects. in an attempt to aver safety in the use of replicating viruses (see below), warfield et al. ( ) tested the protective effects of a virus-like particle in captive chimpanzees using adenovirus as a vector. first, they demonstrated that the vaccine was safe for chimpanzees. second, they documented the development of a robust immune response in chimpanzees, evidenced by a detection of virus-specific glycoprotein and vp antibodies - weeks post-vaccination. third, they demonstrated that total igg fractions taken from the chimpanzees that were vaccinated had a protective effect in mice challenged with murine ebola: - % of mice in the study groups survived compared to none of mice in the control groups. similarly, blaney et al. ( ) developed a live-attenuated and inactivated rabies virus vaccine that expresses the ebola glycoprotein. the vaccine had no adverse effects in primate models, it induced humoral response to both rabies and ebola, and was shown to be protective against both viruses. while this is obviously an early-phase study, it has great potential in terms of resources and feasibility in conferring immunity in mammals against two lethal pathogens. so far, two vaccines have passed phase clinical testing: chimpanzee adenovirus -vectored vaccine encoding ebola surface glycoprotein (chad ) (rampling et al. ) , and vesicular stomatitis virus (vsv)-vectored vaccine also encoding for the outer protein of the zaire ebola strain (agnandji et al. ) . the prevail study is an ongoing phase / trial taking place in liberia that examines the safety and effectiveness of these two vaccines. concomitantly, the strive trial is taking place in sierra leone, where healthy volunteers will be given the vsv vaccine in order to test its safety and effectiveness. agricultural policy tends to follow vaccinating all of the exposed animals so that those not already infected will develop sufficient immunity. however, when time and resources permit, it is normal for all exposed animals to be slaughtered (kahn et al. ) . vp is a matrix protein that together with glycoprotein constitute the virus-like particle vaccine. occasionally, nucleoprotein is also present. vp is essential for cell expression of viral antigens to which the body responds by creating antibodies (escudero-perez et al. ; marzi and feldmann ) . see: http://www.niaid.nih.gov/news/qa/pages/ebolavaxresultsqa.aspx; accessed june . http://www.cdc.gov/media/releases/ /p -ebola-vaccine.html; accessed / ; accessed june . the vsv phase trial in geneva was halted due to safety concerns when several healthy participants developed different adverse effects such as arthritis. the trial was continued a month later, to understand contagion networks and possibilities for control, first we need to see the connections between vectors and victims, and by understanding these within shared ecologies we might be able to better safeguard communities-both animal and human. as these authors postulated: ''in addition to the protection of threatened nhps [nonhuman primates], vaccination of nhp populations in endemic areas might also offer an additional, critical benefit to humans. the interaction of humans and infected nhps has been associated with transmission of ebov to humans and initiation of subsequent outbreaks, so prevention of disease in nhps may also serve to limit ebov transmission into the human population'' (blaney et al. ) . concurrently with the race to develop and test vaccines on human beings, we argue that already now, we can and should (upon assuring the degree of safety) deploy vaccines in captive and wild primates with the aim of benefiting both primates and humans. the current strategies, we submit, are driven by a too narrow vision: we propose that oh espouses a 'shared benefit' approach that is complementary to the 'shared risk' approach (rabinowitz et al. ) . a 'shared benefit' approach seeks to actively maximize health in one species while in turn benefiting another species as well. specifically, we refer here to research and interventions in humans that benefit animals and vice versa. our proposal is to implement the notion of inter-species immunity. one of the identified risks for ebola, while not knowing for sure the reservoirs of the virus, is close proximity between human and primate populations (towner et al. ). our proposal is for direct action to administer vaccinations to humans through public health and research paradigms, and additionally to animals to stave off future outbreaks in both populations. such an approach, aimed at vaccinating animals in the first instance, would be preventative rather than reactive to an outbreak in human populations, by protecting across species and thereby creating a potential barrier to future occurrences of ebola in the fauna. our proposal is to co-develop vaccines for human and primate use in ebola endemic and at-risk sites in africa; and simultaneously, to deploy such vaccines to these sites in animal and (in due course) human populations. the delay in getting vaccines to the people in africa is in part due to the need to conduct proper clinical trials first and the troubling consequences of creating randomization (donovan ; shaw ) . however, captive primate populations could be enrolled in trials as benefiting vaccine development at a lower safety level (in comparison to the footnote continued upon approval by the review committee. the ongoing phase / vsv trials were modified according to the results in that study (agnandji et al. ) . one health, vaccines and ebola: the opportunities for… standard profiles for first in human trials, and additionally avoiding the later phased stages of human clinical trials). primates might be research subjects who can contribute to a longer-term ecologycentred strategy to vaccinate wild animal populations urgently. simply put, researchers are already injecting captive primate populations, and, if proven safe and efficacious in these trials (i.e. would not to our knowledge wipe out remaining primate populations), this approach provides a fast track to wild primate populations. an oh approach would potentially justify animal research on captive primates within parameters of participation of 'vulnerable' populations (i.e. the agents likely to be the first cases or most at risk in future outbreaks because of their situation and circumstances). the next stage would be vaccinating the same species in the wild for the protection both of the same species (primates) and other at-risk species (human beings). this is, firstly, an ethical enquiry involving the status of primates as sentient beings who possess moral value (fenton ) ; and secondly, a conceptualization of animals as vulnerable populations such that risky clinical trials, with conditions, can be ethical. in answering the first enquiry, we note that ebola and the recent chimpanzee trials happen at a time when the national institutes of health is planning to reduce significantly the use of chimpanzees in invasive research, and therefore raises the case of whether minimally invasive research on still captive or retired chimpanzees is ethical at all. we might see experimentation, however, as a parallel development to research and treatment in vulnerable human beings, such as children and other people who cannot consent (wendler ) . the idea here is that trials might benefit wild populations and therefore it might be possible to justify within human research ethics paradigms. in human clinical research, the acceptability of such study is a function of acceptable risk, and, when vulnerability is in question, so are the chances of direct benefit (the 'best interests' test) and the possibility of appreciating benefits for others of one's own kind (children suffering from the same condition, for example). in this sense, developing protocols with primates in captivity might be justified, including using those that have 'retired', to meet the conditions of expediency; but concurrently we must anticipate that there is a direct benefit-or a best interest in play. while potential 'secondary ecological risks' exist, such as accidental extinction of the animal species, there would be some important caveats scholars concerned with animal ethics will blame us here for putting the animals at increased risk compared to humans. however, given a vaccine that has been proven safe in the lab, and the significant risk ebola poses for apes, we believe that the risks posed by the vaccine are proportional to the benefit that might be accrued to the animals themselves. http://www.nih.gov/news/health/jun /od- .htm; news release; wednesday, june , ; accessed june . this perspective is different from the predominant study of exogenous factors such as habitat disturbance and climate change as drivers of ebola emergence, and links directly to the contribution of transmission between gorilla or chimpanzee social groups in the wild. if this equivalency were to remain within an oh approach: that the vaccine is safe enough to use in human phase trials concurrently (shared risk) and that wild apes would receive the treatment as part of the same strategy (shared benefit). if this shared benefit paradigm of securing universal goods is legitimate, then it goes some way in justifying our strategy as mutually benefiting from a single intervention. this raises feasibility problems, but some intriguing ecological repercussions warrant serious consideration of an oh vaccine approach. . one would have to possess extensive knowledge about the reservoirs, vectors and hosts, and hierarchical zoonotic bridges between species, to understand the impacts of vaccines in terms of safety, stability, and effectiveness. this will involve knowledge of human, human-animal, and animal-animal interactions (i.e. comprehensive studies of fauna and flora), and their linked activities within the biosphere. at present, pandemic planning is focussed on public health, and to a degree, anthropocentric studies of how we contract and spread the pathogens amongst our own kind. this focus, for instance, locates some major challenges of vaccine use, specifically high levels of distrust and ambivalence towards medical interventions in some african populations that would impede wide human community vaccination programmes (mark ; macneil and rollin ; mitman ) . one might therefore face resistance in deploying an effective vaccination programme. oh, therefore, helps planners look to other solutions that may complement communitybased interventions. firstly, vaccinating domestic animal populations, both companion animals and those in husbandry, could avoid collateral loss to families and livelihoods. these losses are substantial and as targets for public health intervention might gain widespread support. secondly, and which we focus on here, is developing a novel approach to research and deployment in the field as a protective measure that demands immediate attention. thus, following the approach we outlined above, the vaccine will increase the welfare of humans and wild apes, both as protection (eventually) and in conducting knowledge based trials. to address the expediency argument, we again note that both the chad vaccine and the vsv vaccine have proven to be safe and efficacious in non-human primates (stanley et al. ; geisbert and feldmann ) . the human trials will take time to conclude. clearly, with the primate trials already concluded, there is an while the context of animal vaccinations has been debated considerably in respect to farming practices (and risks to humans as pathogenic risks, food safety and economics), there has been little coverage of the benefits to the animals. the debate is now further sparked by the quarantine and killing of companion animals exposed to potential contagions by their owners, such as the spanish dog killed for the fear of ebola transmission (associated press ). we note that the ongoing debate is deliberate in its assessment to get vaccines into the field as soon as possible to protect health care workers and needed staffing (i.e. burial teams and cleaners). this is a separate, urgent debate which does not entirely equate to the stage wise proposal we make here. however, the design to get vaccines first to primates as a joint shared immunity strategy could expedite human benefits and use, with a focus on employing biologists, veterinarians and the like to target the animal populations. opportunity to deploy these vaccines right away to wild apes. in the short term, we might be seeing every primate that lives as a benefit of vaccine deployment. the long-term benefits are immunity, possibly extending across species and thus limiting the future scope for spillover events. furthermore, it will provide in situ data to be gathered from the wild populations. . achieving broad coverage to widely dispersed animals would be costly and logistically challenging but has been achieved in other settings using low interventional methods such as baiting in the case of rabies (morters et al. ) . one challenge is the difficulty in reaching entire ape populations. the dense tropical forests and the animals' nomadic tendencies would make effective immunization difficult. however, by use of local and interdisciplinary knowledge and expertise, and various vaccination methods such as hypodermic darts and synthetic baits, this obstacle may be overcome (ryan and walsh ) . one long-term strategy may be to create buffer zones around villages by vaccinating domestic and wild animals, that might be enough to minimise risks of future outbreaks, following the alreadyexisting use of designated zones in farmed animal populations elsewhere (kahn et al. ) . the approach would require an increased evidence base, of course, but effectiveness could be achieved by focusing on 'hot spots', localized risk maps (jones ) , and using targeted empirical data, such as weather patterns that are known to influence zoonotic spillover events (bausch and schwarz ) . ring vaccination is another strategy, where vaccines are delivered to animals found in the ryan and walsh ( ) counted different pathogens that are harmful for apes, of which have licensed vaccines. they claim that the major obstacle in dispensing these vaccines is the delivery to the animals (ryan and walsh ) . the authors point out that ''the high seroprevalence among children indicates the same source(s) of exposure [to eobla] as in adults, either inside or near villages''. moreover, because great ape infection is often lethal, and direct contact with humans is rare, some other animal, perhaps bat roosts near settlements, represent the most likely common animal source of exposure: ''these animals, previously identified as a potential reservoir, are abundant in the forest ecosystem and consume fruits on trees located in or around villages'' (nkoghe et al. ) . 'hotspot' maps highlight regions: ( ) where the risk of disease transfer between wild primates and from wild primates to humans is greatest; ( ) where there are cross-species transmission events between wild primates due to a high diversity of closely related primate species; and ( ) where it is most likely that human beings will come into frequent contact with their wild primate relatives. ''these areas also are likely to sustain a novel epidemic due to their rapidly growing human populations, close proximity to apes, and population centers with high density and contact rates among individuals'' (pedersen and davies ). this would have to be an ideal, managed area, additionally creating the rural populations in control of the solutions. there are two elements to achieving this: ( ) engagement, cf. ''far greater community engagement is the cornerstone of a more effective response. where communities take charge, especially in rural areas, and put in place their own solutions and protective measures, ebola transmission has slowed considerably'' (who ); and knowledgeable land use, cf. protecting ''threatened habitats by reminding nearby communities of all the benefits they derive from keeping these habitats intact. forests, meadows and marshes prevent floods, supply clean water, provide habitat for species that pollinate crops, put oxygen into the atmosphere and take carbon out, and otherwise make themselves useful. in some cases, conservation groups or other interested parties actually put down cash for these ecosystem services-paying countries, for instance, to maintain forests as a form of carbon sequestration'' (conniff ). proximity of a known outbreak. further, vaccination campaigns in animals are likely to be cheaper and possibly more temporally feasible than in humans (ryan and walsh ; macneil and rollin ) . . technical issues, including the use of live attenuated viruses as vectors. for example, live attenuated vaccines are more effective than killed vaccines in conferring long-term immunity, thus necessitating fewer vaccine shots and lower rates of compliance and coverage. moreover, using viruses that are replication-competent as vaccine vectors will increase the chances for herdimmunity and therefore the potential for inter-species immunity. however, one of the risks in using a live attenuated, replication-competent vaccine in wildlife is the activation of the attenuated virus and spread to other species, including humans. beyond using killed viruses or viral particles, one solution may be using as vector a species-specific virus. for example, a recombinant murine cytomegalovirus (cmv) that was genetically engineered to express ebola particles was found to be protective in mice. since cmv is highly species-specific, a cmv-based ebola vaccine will potentially spread rapidly in a wildlife population, such as gorillas, without any cross infection to other species (marzi and feldmann ) . the use of replication-competent vectors raises another problem: pre-existing immunity to the virus that is used as the vector will hinder spread of the ebola particles, thereby preventing immunity to be acquired. this challenge could be addressed by the development of vectors to which there is no pre-existing immunity among the specific population. for example, newcastle disease virus, to which there is no detectable pre-existing immunity in humans, was developed as a potential vector of ebola particles with some (limited) positive results. vsv was also used as a vector with little if any pre-existing immunity in humans, with even greater success (marzi and feldmann ; stanley et al. ). the existing challenge with vaccine development was captured by the ghana academy of arts and sciences technical committee. they enumerated that development of vaccine is notoriously tricky given pathogen diseases' drift and other factors that impact on their individual effectiveness with different strains; the possibilities of emergent side-effects and other unforeseen incidents; the distrust of trials originating from certain foreign organisations; and how all of this will affect uptake (both in terms of willingness and immunisation) in the target population. within a 'shared benefit' approach, however, one originating in a one health perspective, we coin the term inter-species immunity to conceptually re-think the notion of immunity within a community; specifically, to extend the goods of health, such as immunity strived for in human populations, to other species and vice versa. we suggest that ebola incidence may be prevented or reduced in one species population by inducing immunity against that pathogen in another species population. so far, the best example of the success of such an approach can be seen in the response to the hendra virus, where vaccination of horses prevented disease in both horses and humans (middleton et al. ). the key to success of inter-species immunity might be with other measures that look to adapt and benefit other ecologies, such as preparing protected ecological zones (removing food and perching areas for bats) based on planned and managed farming areas, and identifying timely and imminent risks to initiate human and animal vaccination in and around these zones. one could adopt already-used surveillance programmes in at-risks regions (these, as we noted earlier, should already be modified to include 'indicative' behaviour in animals of possible zoonoses infection): ''previous serosurveys, together with the geographic pattern of outbreaks, have highlighted the potential role of the ecosystem, and an increased risk among forest populations has previously been described. our study confirms that the forest, particularly the deep forest, is the environment most at risk. this is the area harboring animals susceptible to the virus, such as great apes and bats, the latter representing a viral reservoir'' (nkoghe et al. ). we could not say whether the remoteness and distances between villages could create conditions for regional immunity by lowering the chances that an affected host might infiltrate the buffered populations from long distances away. however, as mentioned, oh is about interdisciplinary collaboration, and solutions to extreme situations such as the current ebola outbreak require such an approach more than ever (middleton et al. ) . understanding the needs of the various stakeholders such as villagers and hunters, and the ecology of all the organisms involved, is without a doubt essential for the success of any viable long-term solution. at the moment, inter-species immunity is likely to involve a programme of trials in captive primate populations, early role out to wild populations (assuming they are safe), and then a concurrent programme to vaccinate human communities in at risk regions (this human challenge is already featured in the literature with respect to other pathogens). however, with the impending imh prohibition on some primate research in the united states, and paralleled restrictions in other countries, this is a window that is potentially closing. invasive great ape research rarely has scientific justification and primate research in general is falling out of favour, although it remains possible in many jurisdictions under strict conditions. invasive research on great apes-using chimpanzees in particular-is likely to be prohibited; but we suspect that monkey research will continue for some time. this might provide the necessary level to proceed to trials in human and great ape populations. so, one could also look at it through a shared vision-if human beings are willing to volunteer for phase one trials, which was highly evident in recent calls, then possibly retired chimpanzees could be coopted as well. at this stage, it will be envisioned that the vaccine is safe for human beings, so this might be an acceptable concurrent risk for primate populations. we surmise that this vaccination strategy, inspired by the ongoing ebola outbreak, might be replicated in future ones. we make the case for the vaccination of wild primates even prior to the completion of the ongoing human trials, with the conditions of optimizing their safety and welfare, and assuring mutual benefits to them and their future offspring, as well as to humans. phase trials of rvsv ebola vaccine in africa and europe-preliminary report ebola and extractive industry strengthening west african health care systems to stop ebola: anthropologists offer insights excalibur, spanish ebola patient's dog, is euthanised despite global outcry. the guardian outbreak of ebola virus disease in guinea: where ecology meets economy ebola outbreak killed gorillas inactivated or live-attenuated bivalent vaccines that confer protection against rabies and ebola 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summary report west african ebola epidemic after one year-slowing but not yet under control bushmeat hunting, deforestation, and prediction of zoonotic disease the ebola outbreak in western africa: ethical obligations for care animal welfare in veterinary practice acknowledgments capps conceived of the idea for this article and led its drafting. lederman was integral to developing the idea and contributed equally to the research for the paper. the authors would like to thank the following people for helpful comments: wang linfa, paul anantharajah tambyah, and sharon amit. key: cord- - yvcl q authors: lawrence, roderick j. title: responding to covid- : what’s the problem? date: - - journal: j urban health doi: . /s - - - sha: doc_id: cord_uid: yvcl q this commentary argues that the coronavirus sars-cov- pandemic should be considered as a transdisciplinary societal challenge that requires coordinated systemic thinking and actions in the context of uncertainty. responses to the propagation of the coronavirus sars-cov- and the health, economic and social impacts of covid- are complex, emergent and unpredictable. we describe the virtuous relations between three prerequisite conditions—multilevel governance, knowledge and types of resources and individual and collective behaviours—that should be combined in transdisciplinary responses. first, multi-level governance of this global pandemic is fundamental. at the outset, we challenge political and public scepticism illustrated by the incapacity of politicians and laypeople to listen and learn from scientific knowledge and professional know-how in the context of uncertainty and vulnerability. governance denotes the way that governments, public administrations, private enterprises and community associations interpret the pandemic, and how they decide collectively to respond to it. in order to reduce known unknowns about this beta-type coronavirus with species jump, the coordinated synthesis of interdisciplinary information and knowledge, professional know-how and individual and social perceptions and understandings are necessary. then this broad understanding can be applied to define the appropriate allocation of many types of resources (e.g. administrative, financial, human, material, medical, pharmaceutical and scientific) necessary to implement effective responses (see fig. ). in contrast to south korea and taiwan, many european countries have reacted by following the propagation of this coronavirus rather than being proactive to prevent it despite the warnings made by scientists from [ ] . the contrasting responses of federal/national, state/regional and city/local authorities between and within countries, since january , illustrate how differently this real-world challenge has been interpreted; for example, comparisons between cities in the lombardy and veneto regions in northern italy highlight successes and shortcomings that can be interpreted as lessons learned [ ] . several types of resources coexist for coordinated action and systemic responses to this extraordinary situation: administrative, behavioural, financial, health care, legal and medical resources, and have been used at different geo-political levels, sometimes in an uncoordinated fashion of 'winner takes all'. notably, some actions have been endorsed by the world health organization (e.g. confinement, quarantine, distancing, testing, washing hands) whereas others have not (e.g. wearing masks in public spaces). the diverse interpretations and responses of governments and public administrations confirm that 'evidence-based policy' is a theoretical concept that is often not applied in current circumstances (like many others including ambient air pollution and passive tobacco smoking). notably, some local authorities in american and european cities have not introduced systematic testing and proactive tracing, or legally binding measures, to protect population health. the second prerequisite condition is the importance of specialised data, information, knowledge and professional know-how required to understand and counteract a new virus for which there is still no proven medical or pharmaceutical remedy. the known unknowns about this coronavirus can be identified and studied using principles of one health, ecological public health, and planetary health during transdisciplinary research and practice in community settings to 'collect facts on the ground' beyond the walls of laboratories [ ] . the nonlinear, uncertain and unpredictable characteristics of this coronavirus are derived from the evolving interfaces between natural ecosystems and human-made environments that accommodate people and all other living organisms that may be vectors of zoonoses including this coronavirus. these novel situations, created by rapid urbanisation in cities and mega-urban regions, can be analysed by interdisciplinary case studies of the multiple consequences of rapid urbanisation. these transdisciplinary case studies should combine biological, epidemiological, medical and veterinary research together with methods of behavioural and social science research. in addition to knowledge and know-how acquired from biological, ecological, health, medical and veterinary sciences, this pandemic confirms the crucial function and contribution of access to many types of resources when they are needed; in particular, sufficient stocks of medical equipment; hospital wards with specialised infrastructure; replenished supplies of pharmaceutical products; adequate numbers of trained and qualified medical doctors, nursing staff and auxiliary personnel in hospitals, medical centres and nursing homes for elderly persons and coordinated uses of all these resources when the virus is first diagnosed in specific localities. we now know from experience in asian countries and italy that the timing of responses to the first diagnosis of this virus in specific cities, and mega-urban regions, is crucial for the effectiveness of counter-measures. the comparison and stark contrast between interventions and resources in asian cities, including seoul, taipei and singapore, compared with london and new york, is a timely reminder that anticipation by proactive thinking, and preemptive measures by prospective planning, vary considerably between countries and cities irrespective of their gdp or political regime. the asian cities learned important lessons from the coronavirus sars-cov- in - , which impacted more than countries, highlighting the fundamental contribution of preemptive measures founded on empirical knowledge. also, national and city comparisons confirm the vital contribution of strategic public health policies after a global shift towards the privatisation of medical and health care services in the last three decades in many countries. ironically, many advocates of laissez-faire and neo-liberal economics now expect governments to intervene to support private enterprises that are financially fragile or bankrupt, fig. effective responses to the complexity, emergence and uncertainty of coronavirus sars-cov- and the compound nature of health, economic and social impacts of covid- require understanding and implementing the virtuous relations between disciplinary knowledge and professional know-how, several types of resources, coordinated multi-level governance, and individual and collective behaviours that should be combined in transdisciplinary contributions. © roderick lawrence including those that failed to provide much needed medical and pharmaceutical equipment currently imported from foreign countries [ ] . the third prerequisite condition that influences effective national, city and communal responses to counteract the transmission of coronavirus concern individual, household and community adherence to behavioural norms and new regulations introduced by national and local governments. some interventions by governments and public administrations concern regulating personal behaviour and interpersonal contacts. for example, norms and rules include different degrees of confinement, controlled access to outdoor public spaces, markets and shops, social distancing, wearing masks and washing hands. public adherence to these norms and rules cannot be assumed owing to cultural, social and psychological reasons including religious customs, spiritual beliefs, group identity and the notion of individual liberty. diverse individual and group perceptions of health risks attributed to coronavirus coexist in societies that have endorsed the supremacy of individualism at the expense of collectivism, the authority of divine providence and rights of humans above all other living organisms on earth. in this context of heterogeneous lifestyles, values and worldviews, appropriate data and information should be effectively communicated to target groups in order to create responsible behaviour not only for individual health, or social well-being, but also for the common good. we now know there are crucial compromises and trade-offs between individual liberty and personal responsibility, as well as fundamental collective choices about how to respond to economic, health and social threats in the context of uncertainty and vulnerability. we also know that a patient-centred strategy that targets highly vulnerable individuals and groups should be complemented by a community-centred approach. the negative impacts of this pandemic confirm a wellknown correlation between socioeconomic inequalities and mortality rates of populations at national, regional and city levels [ ] . while targeting populations should identify and respond to the needs of vulnerable groups, this pandemic confirms that an area-based approach in countries and cities is also pertinent (e.g. wuhan in the province of hubei, china; bergamo and lodi in the province of lombardy, italy). this dual approach, often used in environmental health interventions, underlines the importance of working with an in-depth understanding of the contextual conditions in which the coronavirus has been diagnosed. normative behavioural codes and rules should not ignore the societal context including inter-and intra-urban differences. notably, a who recommendation to wash hands repeatedly is unrealistic for all those people (an estimated million people, % of the world's population) who do not have access to a supply of affordable, clean and safe water [ ] . this brief commentary confirms that our livelihood and our health are strongly influenced by the biological, ecological, financial, political and cultural milieu in which we live. this milieu, our habitat, and our livelihoods, are founded on fundamental monetary and nonmonetary values. the extraordinary situation of the current pandemic should be a catalyst for rethinking the hierarchy of priorities and values used implicitly and explicitly to sustain our societies. the capacity of public authorities, private enterprises, scientists, practitioners and community associations to respond effectively to major public health threats, such as this coronavirus, should be founded on in-depth understanding of the medical, veterinary and societal variables that influence health and quality of life in specific cities. there are significant differences between health impacts in geneva and zurich, switzerland; or between adelaide and sydney in australia; or between boston and new york city in the usa, and these differences need deciphering. in each city, a dual temporal perspective should be used to understand its particularities. initially, short-term responses should respond to patients and curtailing the transmission of the virus within and between cities and countries. this immediate response should be supplemented by mid-and long-term responses founded on strategic actions initiatives that reduce health and economic vulnerability. the growing number of accounts of the impacts of coronavirus in countries and cities north and south of the equator presented by the mass media in recent weeks highlights the shortcomings of neo-liberal economics and the fragility of human life in a world that has been transformed by rapid globalisation and urbanisation. these ongoing processes around the globe have reduced the resilience of many countries and cities to counteract global threats because they have lost their capacity to act autonomously after becoming subservient to global production processes and trade with foreign countries in international markets (e.g. dependent on imported face masks, pharmaceutical products and ventilators from abroad to meet national demand). some wealthy countries, including switzerland, rely heavily on foreign medical and nursing staff to efficiently operate public and private hospitals. surprisingly, some national governments have reacted by reintroducing controls at national borders, which has been ineffective in limiting the propagation of the pandemic to over countries, and the transmission of the virus-provoking excess mortality in countries. global governance is not possible if some countries do not comply with international agreements [ ] . these expressions of nationalism and sovereignty ignore that a global pandemic cannot be contained by closing national borders. the main focus of discussion in european and other countries about the impacts of this pandemic on national economies has concentrated on lower production and consumption (gdp) in , the need for public financial support to maintain private enterprises affected by the pandemic, and grants for employees in the formal sector who have become unemployed. the absence of attention to the impacts of this coronavirus on people working in the informal sector reinforces the lack of concern about health impacts of workers in all sectors (including formal health services, and personal care and welfare) [ ] . it is unrealistic for workers to respect behavioural codes and rules that ignore that person-toperson contact is the basis on which daily work and income depend. media reports indicate that many workers, including doctors and nurses in hospitals and nursing homes, do not have the personal equipment necessary to protect them. finally, public anxiety about this situation, supported by mass media and social networking, should raise major concerns about the quality of life and resilience of all peoples that can be influenced by major ecological threats (e.g. climate change and extreme weather events); economic instability (since in many countries); technological accidents (e.g. fukushima in ) and ongoing civil unrest and warfare in several continents. we need to rethink the real interconnected nature of our lives and the livelihoods of others on earth in contrast to the false claims for nationalism and protectionism in some countries. notably, we recall the plight of many victims of hunger and malnutrition that can be avoided by concerted action. we underline here that about million people die of hunger and malnutrition each year, and million of these are children who starve to death while about a third of all food produced is disposed as waste. likewise, the absurdity of the request for social by staying 'at home' given that not less than million people are declared homeless and . billion are estimated to live in inadequate housing [ ] . the fundamental issue is whether the current pandemic will be a catalyst for collective radical rethinking about the future of 'us and others' in a world that should become more ecologically responsible, more economically just, and more socially equitable for the common good, or a shared quest for returning to 'business as usual'. emerging infections: what have we learnt from sars? lessons from italy's response to coronavius academic institutions and one health: building capacity for transdisciplinary research approaches to address complex health issues at the animal-humanecosystem interface beware the fragility of the global economy global water, sanitation, and health (wash do not violate the international health regulations during the covid- outbreak according to the international labour organization (ilo), about billion people work informally, most of them in emerging and developing countries. see ilo 'women and men in the informal economy: a statistical picture united nations, department of economic and social affairs publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations and invited professor at the international institute for global health at the united nations university (iigh-unu) in - . he has been a member of the scientific advisory board for interdisciplinary and transdisciplinary research at the swiss academy of sciences (scnat) s i n c e key: cord- - spqe r authors: supady, alexander title: consequences of the coronavirus pandemic for global health research and practice date: - - journal: journal of global health doi: . /jogh. . sha: doc_id: cord_uid: spqe r nan the discussion primarily focuses on clinical treatments and public health responses in high-and middleincome countries. but, due to the pandemic spread of the virus, we must expect further spreading of the disease to countries with weak public health and health care systems, which may easily be overwhelmed by the occurrence of many patients within a short period. we must consider the potential impact of current travel and movement restrictions on global health interventions and research projects. by nature, global health practice and research heavily relies on international exchange and free international movement of persons and goods. travel restrictions, if upheld for a longer time, may interfere with project plans and interventions. vulnerable individuals and populations may suffer from interruptions in the provision of health services. ongoing projects and interventions may be paused, planned projects may be postponed -this can affect the lives and the well-being of many people. the risk management of the covid- -pandemic in the context of global health research and practice not only needs to take into account microbiological and epidemiological knowledge and expertise on the characteristics and spread of sars-cov- , but also social and economic impacts and challenges in different countries and settings. on the one hand, the resumption of temporarily interrupted projects may endanger people by unintended the coronavirus pandemic challenges ongoing and planned global health research and practice activities throughout the world; project planners and responsible persons must cautiously balance out the risks of interruption and resumption of the projects in the respective settings. transmission of the virus from researchers, aid workers and other project staff to people in vulnerable settings. nearly all populations within the focus of global health research or interventions must be considered at a particular risk. clinical data suggest that elderly and immunocompromised persons are at a very high risk of infections and poor outcomes when infected with sars-cov- , the high contagiousness of the virus puts people in densely populated settings, such as refugee camps, at a particular risk [ ] . on the other hand, disease control measures successfully implemented in high-income countries, may not be the preferred nor the adequate solution for all countries and settings. sustained lockdowns, first imposed on the city of wuhan in china and later announced in almost all countries seriously affected by the pandemic, may not be rational everywhere, considering practicability, proportionality and potential side-effects. proportional and context-adequate measures need to reflect the age-structure of the populations and further risk-factors for developing serious or fatal courses of covid- . young people are at a lower risk for developing serious covid- than elderly, whereas non-communicable diseases such as hypertension, diabetes, pulmonary or heart disease, that are prevalent in many low-and middle-income countries, are known risk factors for unfavorable courses of covid- [ , ] . therefore, information on the age-structures and diseases and risk-factors in different communities and societies need to be included critically in the decision-making and project-planning process. equally important, though, are the economic and social implications of the interventions. in many resource-constrained settings, people work as day-laborers or they live from subsistence economy; many live in densely populated urban settings. under these conditions, sustained lockdowns, movement and contact restrictions are not only impossible to upheld, but they will also have serious side-effects such as further impoverishment and hunger, which also endanger the health and survival of the people. project managers and people in charge must very cautiously discuss and evaluate the balance of risks of extended interruption and continuation before resuming the projects. this evaluation process may yield different results and consequences for different settings. photo: kutupalong rohingya refugee camp in bangladesh. densely populated refugee camps are highly vulnerable to the spread of coronavirus (from the author's own collection, used with permission). there will be no one-size-fits-all-solution -different local circumstances will require different approaches and security mechanisms. the current situation may be considered a chance for restructuring the global health system, establishing more resilient and sustainable structures. the more we learn about the spread and contagiousness of sars-cov- the better we can develop strategies to resume project work while providing safety to people at risk. the availability and the use of personal protective equipment (ppe) and the possibility to wash or sterilize hands regularly need to become routine in global health projects. the coronavirus pandemic may thus help to reconsider and redesign the basic structure and foundations of global health research and practice. recently, the contradiction between frequent international air travel of global health professionals and researchers and efforts of mitigation of climate change has been discussed [ ] . this discussion may well be extended to questions of disease prevention in light of international spread of pathogens. further and more extensive strengthening of local capacities and empowerment of human resources in many low-and middle-income countries that are in the focus of global health activities will help to decrease the demand of deployment of foreign staff. long distance air travel for short meetings should be reduced. instead, long term exchanges of staff can strengthen institutional ties and help to guarantee consistency in the projects. technology may also play an increasing role in global health projects -video calls and conferences should be used more often in project planning and team exchange. therefore, strategic planning in international cooperation and global health should also keep an eye on the spread of digital technologies and the availability of broad-band internet connections -mobile or landline network based. the ongoing coronavirus pandemic puts particularly strains on the global health system. we may use this exceptional situation to reconsider and restructure the system for the better of global population health and well-being. clinical features of patients infected with novel coronavirus in wuhan coronavirus disease (covid- ) situation reports available host susceptibility to severe covid- and establishment of a host risk score: findings of cases outside wuhan clinical characteristics of deceased patients with coronavirus disease : retrospective study clinical course and risk factors for mortality of adult inpatients with cov-id- in wuhan, china: a retrospective cohort study air travel for global health: flying in the face of sustainable development? key: cord- -gv i oeh authors: coghlan, ben; hall, david title: the development of one health approaches in the western pacific date: - - journal: one health: the human-animal-environment interfaces in emerging infectious diseases doi: . / _ _ sha: doc_id: cord_uid: gv i oeh the western pacific region, the most populous of six regional groupings of world health organization (who) member states, has seen the emergence of a series of novel zoonotic infections in the last decade. this has focused attention on addressing underlying risks and vulnerabilities in the complex interactions among people, animals, and environments as a better way to counter emerging diseases. this “one health” approach is pertinent to the region because, it is a “hot spot” for the emergence of novel diseases from wildlife, because unexpected epidemics of re-emerging zoonotic diseases have caused morbidity and mortality in urban and periurban communities, and because it remains a sanctuary for well-known zoonotic infections. in this chapter, selected regional, multicountry, and national steps to operationalize one health are discussed. while the region is well positioned to exploit the opportunities that have come with outbreaks of new diseases, the array of disconnected and overlapping initiatives from various consortia, donors, research institutes, and un agencies is to some extent impeding the development of better ways of managing both new and old infections for the local, regional, and global good. the western pacific region is one of six regional groupings of world health organization (who) member states. it is the most populous region with over onequarter of the global population living in countries and territories (world health organization, western pacific region ). these countries are diverse: from china with the world's largest population to some of the world's smallest states like the pacific islands of niue, tokelau, nauru, and tuvalu (population reference bureau ); from one of the most densely populated countries, singapore, to the least densely populated country mongolia (population reference bureau ); from highly developed states such as australia, japan, and the republic of korea to countries ranked among the world's least developed like papua new guinea and the solomon islands (undp ) (table ) . the emergence of a series of novel zoonotic infections from the region in the last decade triggered an unprecedented mobilization of the international public health community to address these threats. sars in , exposed weaknesses in national capacities to quickly identify, contain, and control a novel infection; these weaknesses equate to a persisting global threat. in and then again in , bird flu (influenza a/h n ), the largest epizoonosis ever recorded, sounded a second call for global pandemic preparedness highlighting not only the shortcomings of human health services but the challenges of strengthening animal health and production systems, of restructuring food supply chains, and of sustaining responses for years. the virus remains endemic in poultry in china and vietnam and has demanded far more than just emergency responses. there is recognition that strategies to reduce the likelihood of disease emergence and transmission by addressing underlying risks and vulnerabilities in the complex interactions among people, animals, and environments, between human systems and natural ecosystems, may be a better way to counter emerging diseases. this has been referred to in various contexts as ecohealth (charron ), particularly where it includes consideration of the role of environmental factors, and as a one health approach in which health disciplines work together rather than in exclusion. this ''one health'' approach is pertinent to the western pacific region for three reasons. first, the mekong subregion within the western pacific region has been designated a ''hot spot'' for the emergence of novel diseases from wildlife because of an amalgam of related anthropogenic drivers of disease emergence: rapid economic development, urbanization, advancing farming systems, demand for livestock products and deforestation, as well as population increases and aging (jones et al. ) . these factors cannot be addressed by the human or animal health sectors alone, necessitating a collective engagement with a range of sectors and communities. second, unexpected epidemics of re-emerging zoonotic diseases including rabies, anthrax, and leptospirosis have caused morbidity and mortality in urban and peri-urban communities in the western pacific region. some of these epidemics are being addressed using one health approaches, and indicate the value in learning from and working with partners in the region when developing public awareness and preparedness plans for emerging infectious diseases (eids). third, the region remains a sanctuary for well-known zoonotic infections such as brucellosis that have been eliminated in many parts of the world but may be effectively addressed with an approach that is better tuned to tackle the complexities of real-world problems (world bank ). it is fitting then, that serious global commitment to this nascent approach was made in the region in hanoi in : the international ministerial conference on animal and pandemic influenza aimed to ''set the scene for a worldwide effort, over the next years'' declaring the ''…need for sustained, well-coordinated, multisector, multi-disciplinary, community-based actions to address high impact disease threats that arise at the animal-human-environment interface.''(unsic ). numerous overlapping global and international initiatives from various consortia, donors, research institutes, and united nations (un) agencies are being implemented in the western pacific region. while some initiatives have committed to improve coordination through systemic measures such as the one world, one health initiative (fao et al. ) and the fao-oie-who collaboration concept note on health risks at the human-animal interface (who et al. ) , there is no overarching coordination of the multitude of activities being conducted in the region under a broad interpretation of one health-this was emphasized at the recent davos one health summit with a major conclusion being the need to ''intensify the collaboration and coordination between the leading and rele-vant…institutions in the broader one health area'' (ammann ) . in general, there are also no direct links with other global endeavors such as the millennium development goals (un web services section ) and the millennium ecosystem assessment (millennium ecosystem assessment ). some of the global/international initiatives and organizations implementing these activities in the western pacific region are listed below (table ) . only a selected number will be discussed in this chapter. this is an incomplete listing, but is illustrative of both the variety of work being addressed by various actors and institutions and the numerous (separate) networks operating in an environment of a broader one health movement. operationalizing one health western pacific ministries of health and agriculture have had experience of being abruptly forced to work together in new ways to address new diseases. not all interactions have been successful, and efforts to date have not yet fully embraced a one health approach, as most stakeholders currently understand it; rather, most initiatives are continuing efforts to combat key eids. there are, however, a number of endeavors that illustrate the movement towards one health. most of these initiatives are at the regional rather than the national or community levels. the cornerstone of regional plans to confront eids is the asia pacific strategy for emerging diseases (apsed) (world health organization ; world health organization, western pacific region ). this is essentially a ''health security'' construct aiming to strengthen national systems to comply with the legal requirements of the international health regulations ( ) (world health organization ) and to improve national capacity to combat eids. the latest iteration of the strategy ( ) drew heavily on the lessons learned from the pandemic of influenza a/h n and allows countries flexibility to decide how they can best achieve the vision of the eight areas of focus: ( ) surveillance, risk assessment, and response; ( ) laboratories; ( ) zoonoses; ( ) infection prevention and control; ( ) risk communications; ( ) public health emergency preparedness; ( ) regional preparedness, alert, and response; and ( ) monitoring and evaluation. the emerging disease surveillance and response unit of the who is responsible for assisting countries to implement apsed. apsed is not a one health vision, however, lacking the synergies between all sectors whose activities impact on health. asia pacific economic cooperation (apec) considers emerging diseases to be of high importance because of their preventability and the substantial direct (e.g., treatment and hospitalizations) and indirect (e.g., lost time to work, trade sanctions) costs that such diseases have caused to their members states in recent years. since , apec has supported the apec emerging infections network (apec einet ), a network that seeks to gather and disseminate notifications of eids affecting apec member states, foster collaborations among academic institutes, government, and business where they relate to eids, and enhance regional biopreparedness. this mechanism is useful for dialog between sectors beyond just the animal and human health sectors, although the degree of communication and idea sharing does not approach the transdisciplinarity advocated by most one health proponents. nonetheless, apec did fund the technology foresight project ( - ) (the apec center for technology foresight national science and development technology agency ; damrongchai et al. ), a succinct effort in transdisciplinarity that brought together a range of experts from policy makers and technology developers to virologists and economists to map the convergence of new technologies and the opportunities for their accelerated development in order to limit the human and financial impact of novel diseases. while narrowly focused on the technological aspects of disease prevention and control, and a project rather than an ongoing, inbuilt process, this work encompassed the development of new vaccines, treatments, diagnostics, models and simulations, and tracking strategies for people and animals. apec have since drafted a one health action plan (asia-pacific economic cooperation ) setting out a common ''vision'' for member states to operationalize one health approaches according to their capacities and level of engagement with the concept. the plan aims to strengthen cross-sectoral efforts at the political and leadership level, in teaching and training, in (government) functions to prevent, investigate, respond and control diseases, and across borders. the community is identified as a critical partner in disease prevention and control, and action to ensure the sustainability of cross-sectoral approaches is called for. the association of southeast asian nations (asean) has defined a roadmap to prevent, control, and eradicate highly pathogenic avian influenza (hpai) and other highly pathogenic emerging diseases among member states by using a riskbased approach to address the major transmission pathways in each country (asean secretariat a). the roadmap describes itself as a ''translation'' of the one health approach to systematically eradicate hpai, while simultaneously addressing other transboundary and zoonotic diseases. while the focus is on animal health and production, the advantages of engaging with multiple disciplines, multiple sectors, and multiple agencies are noted. this is an encouraging output from asean, but is one of the few documented instances of asean activities related to one health, either in progress or completed. furthermore, the emphasis on hpai rather than a broader one health approach potentially misses an opportunity to embrace a wider notion of health including the role of wildlife, the integration of resources from various health and nonhealth authorities, as well as concrete plans for regular communication across health and related disciplines. asean is in a unique position to be the premier institution in asia coordinating, influencing, and even governing to some degree an integrated one health approach for part of the western pacific region. the hpai roadmap is a step in the right direction but much remains to be done if asean is to be a one health leader. asean's biggest challenge may be the reluctance of member nations to advise on what others should be doing. this is, however, a requirement for an integrated one health network to be effective among the member states. the asean plus three eids programme has improved joint country investigations of disease outbreaks and developed a regional risk communication strategy (asean secretariat b). a new program funded by the japanese government is directed at improving laboratory capacity and networking (asean secretariat ), continuing a long and successful history of japanese funding to develop diagnostic and research laboratory capabilities in the region. the food and agriculture organization (fao) regional strategy for highly pathogenic avian influenza and other eids of animals in asia and the pacific, - (emergency centre for transboundary animal diseases ) outlines a common approach for dealing with endemic hpai and for addressing emerging and re-emerging diseases. the strategy also aims to join up the fragmented support provided by various partners and donor agencies within the region. this is the latest in a series of initiatives led by fao and its partners to combat hpai since the first outbreaks in southeast asia, initiatives that were themselves preceded by other efforts founded in one health concepts including the fao emergency prevention system (empres) and the global framework for the progressive control of transboundary animal diseases (gf-tads). most of the major pacific basin donors have made significant contributions to initiatives to address emerging diseases. the public health agency of canada leads the canada-asia regional emerging infectious disease (careid) project aiming to strengthen the capacity of cambodia, laos pdr, the philippines, and vietnam to detect and respond to emerging diseases (public health agency of canada ). similarly, the australian government's international development assistance agency has articulated a regional strategy for strengthening health systems to respond more generally to eids: the pandemics and eids framework - (ausaid ). the asian development bank has implemented a series of communicable diseases control projects along borders in the greater mekong region to improve community surveillance of endemic and epidemic diseases including eids (asian development bank ) . and the usaid emerging pandemic threats program (u.s. agency for international development ) operates globally with specific activities related to four project areas in southeast asia: wildlife pathogen detection, risk determination and reduction, outbreak response capacity, and institutionalization of a one health approach. this last element is elaborated on in the next section (academic initiatives). the european union (eu) has also been active in supporting one health initiatives through a range of endeavors. the flagship is the eu regional highly pathogenic emerging diseases (hped) in asia programme ( - ) (european commission ) which spans two who regions, the western pacific and the south-east asia regional offices. it aims to help asean and the south asian association for regional cooperation (saarc) to control, respond, and prepare for these diseases, and aligns with specific initiatives of oie, fao, and who via separate projects channeled through these three un specialized agencies. the european external action service recently published a comprehensive examination and summary of one health case studies, many of which are active in the region, and a complementary database of one health initiatives, studies, and actors (hall and coghlan ) . this publication is well positioned to act as a guide in identifying individuals who can serve as one health focal points in the region and to provide a starting point for operationalizing regional activities and networking in one health. it is important to note that the eu has commented in a number of fora that an approach to one health needs to be positioned with consideration of societal needs. this ''whole of society'' approach to health hazards will require a widescale change in the attitudes and perspectives health professionals hold with regard to risk management. there are a number of existing networks of southeast asian universities that encompass aspects of one health such as the asean university network, the asia partnership on emerging infectious disease research, the asia pacific academic consortium for public health, the asian ecohealth network, and the southeast asia veterinary schools association. through the respond component of the emerging pandemic threats program (u.s. agency for international development ), usaid is supporting a new one health academic collaboration, southeast asia one health university network (seaohun) (fenwick ) , that brings together multiple faculties including schools of medicine, veterinary science, public health, and allied sciences from universities throughout the region. cambodia, laos, indonesia, malaysia, thailand, and vietnam have universities that belong to the network with china, myanmar, and the philippines to join in . the network aims to develop transdisciplinary capacity to investigate and control outbreaks of emerging diseases and to build the evidence base for one health approaches through research. this effort will define one health competencies and develop a common regional approach to incorporating them into accredited education and professional in-service training. the mekong basin disease surveillance initiative (mbds) (mekong basin disease surveillance a) is a network established in to advance cooperative action among the six countries of the mekong subregion to improve infectious disease surveillance and outbreak response. this aims to ''reduce morbidity and mortality from communicable diseases, particularly amongst marginalized people living in the mekong region'' (mekong basin disease surveillance b). from sharing of surveillance data from four border sites in , the scope of the network has expanded through a second memorandum of understanding (mou) in to the consideration of community-based surveillance, epidemiology capacity, information and communications technologies, risk communications, laboratory capacity, policy research, and extended cross-border cooperation. these seven new strategies will contribute to the development of national capacities identified in the international health regulations ( ) (world health organization ) to detect, investigate, report, and respond to public health threats. while not originally envisaged as a one health activity and lacking some of the attributes of a one health network, mbds nevertheless provides a successful framework on which one health approaches can be added or modeled. the office international des epizooties (oie) coordinates the southeast asia foot and mouth disease (seafmd) (oie ) across eight asean countries, a program recognized internationally as a model for regional coordination of animal disease control. although foot-and-mouth disease (fmd) is not normally considered as a zoonotic disease (it rarely causes mild skin lesions in humans), the model stands as an example of an integrated effort among government agencies, international organizations, village communities, and donors all committed to controlling one disease. individual national plans are harmonized with a regional strategy that has received high-level political commitment and that has adopted a progressive, longterm approach for the eradication of fmd. close cooperation and the introduction of new techniques including zoning to roll back fmd in various parts of southeast asia including malaysia and thailand have contributed to the success of the program. together with a large number of partners, international livestock research institute (ilri) is involved in a number of initiatives that could be deemed pertinent to one health. ecohealth approaches to the better management of zoonotic emerging infectious diseases in the southeast asia region (ecozeid) (gilbert ) adopts a learning by doing approach in six countries aiming to demonstrate how capacity for research and disease control can be developed to address specific risks and impacts of eids. ilri also manages the field building leadership initiative (fbli): advancing ecohealth in southeast asia (china, indonesia, thailand, and vietnam) (tung dx ) . this program combines research, capacity building through education and in-service training, and knowledge translation through connections to policy makers to design sustainable agricultural practices that result in improvements to human health, livelihoods, and environments. care australia implemented locally tailored community-level pilot projects to enhance disease surveillance and reduce risk behaviors related to avian influenza in cambodia, laos, vietnam, and cambodia during - (ausaid . although this program has concluded, the ensemble of projects elucidated some of the earliest lessons for operationalizing one health in the western pacific region: the importance of political, organizational, and community commitment to move lessons from pilots into systematic practice; sustained application of resources to stimulate lasting culture change; and the value of mixing multiple disciplines and agencies to overcome the gordian knot of competing priorities in order to develop acceptable, effective solutions. in the region, idrc is also co-funding with the australian agency for international development (ausaid) a related project on a smaller scale: the building ecohealth capacity in asia (beca) project ) which aims to increase involvement of researchers in ecohealth and one health initiatives. although this is a relatively small project, it has been contributing to building a network of researchers working with several of the initiatives outlined in this chapter. along similar lines, the canadian and australian governments jointly fund the ecohealth emerging infectious diseases research initiative (eco eid) (idrc crdi ), a multicountry project supporting research on how diseases emerge and spread in southeast asia and china, as well as developing research capacity and improving the translation of research into policy. a rare nondisease focused approach branded with the one health label, national center of competence in research (nccr) (national center of competence in research north-south ) has mapped changing land use patterns and the transformation of agriculture in lao pdr and vietnam and are linking this with public health and economic impacts for small-scale farmers. nccr is also documenting the health issues faced by internal migrants in vietnam whose movements and changing employment have been triggered by rapid economic development. these activities demonstrate the potential breadth of the one health approach in moving beyond traditional ideas of the boundaries of health. the majority of emerging disease ''events'' since have been zoonoses and the majority of these jumped from wildlife (jones et al. ) . such viral spillovers have focused attention on interactions with wildlife and their environments; wild animals are also increasingly being farmed in southeast asia. a group of partners selected malaysia because of nipah virus and china because of sars coronavirus to examine the risk of viral emergence among people regularly exposed to diverse animal species (hunters, indigenous people, and market workers) (ecohealth alliance ). project partners include ecohealth alliance, the global viral forecasting initiative, the malaysian ministry of health and departments of wildlife and national parks and veterinary services, the guangdong entomological institute and centers for disease control, and the chinese institute of zoology. this network brings together a range of animal and human health actors to specifically study aspects of the crucial intersection among animals, humans, and the environment that the one health approach intends to address. rather than overtly applying one health approaches, national level planning has, with few exceptions, evolved along targeted planning for specific diseases coupled with some generic pandemic preparedness. in cambodia, the national committee for disaster management (ncdm) has ultimate responsibility for dealing with emergencies of any nature and has played a key role in coordinating responses to hpai. specific plans for how ministries cooperate during emergencies have been outlined and align separate departmental plans (sovann ) . the bureaucratic arrangement of responses to zoonoses under an emergency structure is different from many countries in the region. in principle, however, a one health approach includes the components of disaster risk reduction as expressed in the hyogo framework for action, - (united nations international strategy for disaster reduction ). the global environmental institute is a beijing-based nongovernmental organization that seeks to develop sustainable market-based models to untangle domestic environmental issues through engagement with local communities, government agencies, research groups, civil society, and the private sector (the global environmental institute ). unlike most initiatives in the western pacific region, this organization is not being driven by concerns about specific infectious diseases and embraces a somewhat broader concept of one health that intimately links with private enterprise. from a similar perspective, kunming medical university and the world agroforestry centre, kunming has been developing projects and programs to address national ecohealth issues. both institutions have played key roles in leading one health and ecohealth research in china, particularly research in mountainous regions. the national eid coordination office of the government of laos has recently been established a zoonosis coordination mechanism that enables collaborative action by the ministry of health, agriculture, and forestry to control zoonotic diseases (lao voices ). outbreaks of a new disease, nipah virus, led to the formation of an interministerial committee for the control of zoonotic diseases directly linking human and veterinary health actors. nipah virus provided a key case study of how disease incursions from wildlife can be amplified by human activities and rapidly spread in the absence of sensitive surveillance systems and rapid responses. the imperative to link-up animal and human health actors in asia has been less pressing in the pacific where the livestock sector is smaller and where hpai has had only a limited impact. low population density, the nature of market value chains in which livestock may be less likely to return to vendors, and fewer migratory bird flyways associated with hpai may be other reasons for the slower development of one health activities in the pacific. nevertheless, pacific island countries and territories have been a general source of concern for the region in that any weak link increases the regional vulnerability to emerging and re-emerging infectious diseases. under the umbrella of international and regional programs such as gf-tads (oie regional representation for asia and the pacific ) on the animal health side and international health regulations (ihr) and apsed on the human health side, sectoral capacities have been gradually improving. efforts to develop a regional one health strategy, however, have not yet been realized. one health approaches have obvious application in addressing endemic diseases of animals in some of the larger pacific states, as well as efforts to conserve biodiversity. the filipino government has established an inter-agency committee on zoonoses composed of representatives from the department of health, department of agriculture, and department of environment and natural resources (aquino iii bs ). vietnam has been one of the countries worst affected by hpai (a/h n ) in terms of the impact on the formal and informal agricultural sectors and on human life. the government quickly developed a joint program run by the ministry of health and ministry of agriculture and rural development to address h n . this joint action culminated in a new strategy, the vietnam integrated national operational program on avian influenza, pandemic preparedness and emerging infectious diseases (aiped), - : strengthening responses and improving prevention through a one health approach (vietnam ministry of agriculture and rural development and ministry of health ). while still focusing on the elimination of h n , the strategy has adopted a risk-based approach to attending to the drivers of disease emergence to prevent a range of known and unknown communicable diseases. it involves government, nongovernment, community, and private actors. it remains to be seen how well this can be implemented. nonetheless, this is one of the first incorporations of one health principles in a national plan. with the support of usaid, vietnam has also been active in developing an academic network to support training and research in one health. the vietnam one health university network (vohunet) is part of the seaohun. the application of one health in the western pacific region is in an early phase with few concrete examples of successful operationalization; even from these few examples there appear to be many areas of duplication and lack of coordination. nonetheless, serious attempts at articulating attributes of one health considered important for the region have been made in strategies and documents at the regional level with serious commitment to implement one health approaches. this illustrates the sharp shift in thinking about the components of disease control and preparedness that have come with the surfacing of new diseases; the need for broader input from numerous sectors and the involvement of communities are seen as essential to balance competing ideas and to generate creative, innovative responses. relearning the age-old lesson that human action (and inaction) plays a fundamental role in disease emergence has renewed focus on the possibilities of prevention including prevention that reaches to tackle determinants far upstream. this, however, demands even greater levels of interaction and communication to manage complex human and natural ecosystems. the western pacific region is well positioned to exploit the opportunities that have emerged with recent, dramatic outbreaks of new diseases and to accelerate the development of better ways of managing both new and old infections for the local, regional, and global good. these opportunities are also opportunities for donors involved in health and agriculture and those committed more generally to socioeconomic development to join up siloed initiatives. and the vacuum of governance is yet another opportunity to establish a means of leadership, mentorship, and coordination in the region to reduce inefficiencies, link disconnected networks, improve understanding and knowledge transfer, and speed capacity development and preparedness planning. proceedings of global risk forum one health summit davos ''one health, one planet, one future apeir ( ) asian partnership on emerging infectious disease research creating the philippine interagency committee on zoonoses, defining its powers, functions, responsibilities, other related matters and providing funds thereof the official website of the association of southeast asian nations. joint statement of the th asean+ health ministers meeting singapore greater mekong subregion (gms) regional communicable diseases control (cdc) project: cambodia apec one health action plan: a framework to assist apec economies strengthen cross-sectoral networks and functioning against the threat of emerging and zoonotic infectious diseases community-based avian influenza risk reduction program for the mekong region phase : mid-term review report innovative applications of an ecosystem approach to health. international development research centre zoonotic emergence network (zen), china and malaysia emergency centre for transboundary animal diseases, regional office for asia and the pacific and the food and agriculture organization of 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emerging diseases global trends in emerging infectious diseases laos discusses zoonotic disease co-ordination mechanism infectious diseases outbreak rapid response manual seafmd campaign-home page oie regional representation for asia and the pacific ( ) global framework for the progressive control of transboundary animal diseases (gf-tads) world population data sheet public health agency of canada ( ) canada-asia regional emerging infectious disease (careid) project mainstreaming disaster risk management into local and national development planning. presented at the th meeting of the adpc regional consultative committee on disaster management roadmapping converging technologies to combat emerging infectious diseases: a project of the asia-pacific economic cooperation (apec) and the industrial science and technology working group (istwg) field building leadership initiative: advancing eco-health in southeast asia. presented to the progress meeting on ecosystem approaches to the better management of zoonotic emerging infectious diseases in the south eastasian region a gateway to the un system's work on the mdgs. department of public information human development reports. international human development indicators hyogo framework for action: building the resilience of nations and communities to disasters report prepared by unsic u.s. agency for international development ( ) emerging pandemic threats: program overview - : strengthening responses and improving prevention through a one health approach. vietnam ministry of agriculture and rural development and ministry of health world bank, washington world health organization ( ) international health regulations securing our region's health: asia pacific strategy for emerging diseases. world health organization zoonotic diseases: a guide to establishing collaboration between animal and human health sectors at the country level. world health organization world health organization, western pacific region ( ) asia pacific strategy for emerging diseases world health organization, western pacific region key: cord- - pcb enl authors: siedner, mark j.; gostin, lawrence o.; cranmer, hilarie h.; kraemer, john d. title: strengthening the detection of and early response to public health emergencies: lessons from the west african ebola epidemic date: - - journal: plos med doi: . /journal.pmed. sha: doc_id: cord_uid: pcb enl mark siedner and colleagues reflect on the early response to the ebola epidemic and lessons that can be learned for future epidemics. • strategies to consider include development of a more precise system to risk stratify geographic settings susceptible to disease outbreaks, reconsideration of the international health regulations criteria to allow for earlier responses to localized epidemics before they reach epidemic proportions, increasing the flexibility of the world health organization director general to characterize epidemics with more granularity, development of guidelines for best practices to promote partnership with local stakeholders and identify locally acceptable response strategies, and, most importantly, making good on international commitments to establish a fund for public health emergency preparedness and response. • the recent success of the global action to stem the ebola virus disease epidemic is laudable but should not encourage complacency in our efforts to improve the global public health infrastructure. in march , guinea identified cases of ebola virus disease (evd) and reported them to international health agencies [ ] . nearly twelve months later, the epidemic, having exploded into neighboring sierra leone and liberia, has reached over , cases and nearly , deaths. the toll on human life, impact on health infrastructure, diversion of funding from routine-but critical-priorities, and concentrated mortality among health care workers places the epidemic among the worst disease outbreaks in recent history. after a delayed response [ ] , the world health organization (who) laid out a programmatic roadmap to mobilize financial support and human resources [ ] . in addition, for the first time in its history, the united nations (un) security council has authorized an emergency health mission, the un mission for ebola emergency response, with assets typically committed to peacekeeping. the massive response that followed, involving multiple foreign governments, multinational partners, and regional ministries of health, has brought unprecedented resources to the west african region. towards the end of , the epidemic showed signs of coming under control, particularly in guinea and liberia. compared to worst-case scenario estimates from earlier in the epidemic, this global response has likely saved many thousands of lives [ ] . but while the international response has become an example of the great potential of the global public health community, it also revealed critical weaknesses. had these same partners responded earlier and more effectively after the first signs of an uncharacteristic outbreak, it is likely that the number of lives lost, the impact on health infrastructure, and the magnitude of the eventual response could have been drastically diminished. it is incumbent upon the global public health community to identify gaps revealed during the early stages of the epidemic so that we improve our collective ability to detect and respond early to the inevitable next emerging disease. we offer lessons from the west african ebola epidemic and propose solutions for future international health emergencies. experts have observed that large-scale threats from evd are limited primarily to countries with weak public health systems [ ] . the current epidemic has supported, if not confirmed, this observation. previous evd epidemics, almost all of which occurred in low-and-middle-income countries (lmics) and predominantly in rural areas, have been controlled within weeks, with the largest prior outbreak claiming less than lives. in contrast, the current west african outbreak has now killed more people than all previous evd outbreaks combined. whereas who generally considers the health infrastructure of involved countries when assessing the risk of a potential public health emergency, this outbreak has revealed that a more granular consideration of risk will be of value. guinea, sierra leone, and liberia are all recovering from prolonged periods of civic unrest and suffering from decimated health systems with limited human resource capacity and thus demonstrate that all lmics should not be considered the same. for example, nigeria, another country broadly characterized as a lmic, provides a clear illustration of how a functional, albeit limited, public health infrastructure can successfully bring an evd outbreak under control [ ] . the country responded rapidly through efforts in public education, isolation, quarantine, contact tracing, and case identification to control an epidemic after only cases and deaths in a little over a month. consequently, when a disease of epidemic potential emerges, the international community should pay increased attention to the capacity of the local health system. for example, who could create and maintain a curated scoring system of lmics to include standard measures of health infrastructure, including the availability and sufficiency of the health care work force, surveillance and laboratory capacity, and personal protection equipment availability and supply chains. moreover, a careful analysis of factors that contributed to variations in epidemic severity might lead to identification of additional characteristics to include in a ranking system. for example, local burial practices, having had prior local experience with a similar outbreak, and urban versus rural environments appear to have contributed to variations in the severity of recent west african evd epidemics. with a more precise risk stratification system, who and international partners could give expedited and focused attention to countries on the list that have a particularly weak health infrastructure. this would facilitate faster and stronger responses to both routine and extraordinary health threats, as well as help to target routine support for health systems strengthening. who primarily relies upon the revised international health regulations (ihr) to define a public health emergency of international concern (pheic), and to determine when such announcements should be made to alert the global community. to improve their predictive accuracy and effectiveness, who should reexamine the ihr's criteria for declaring a pheic following each major public health emergency. this strategy will enable who to incorporate the lessons learned from each event to guide future responses. multiple characteristics of the west african evd epidemic have revealed areas for potential improvement. first, this outbreak exemplified the importance of an often neglected criterion in the ihri.e., paying particular attention to cases in which "external assistance [is] needed to detect, investigate, respond, and control" the incident [ ] . although this criterion is included in the ihr as a consideration, it is subordinated to others, such as the present number of cases, which risks missing detection of threats before they reach epidemic proportions. this epidemic, in which the regional health infrastructure was quickly overwhelmed, taught us that a need for external assistance ought to become a primary condition for declaring a pheic. doing so would assist struggling member states with weak health infrastructures in the crucial early stages of response. second, the ihr partially define a pheic as a disease outbreak that "constitutes a public health risk to other states through the international spread of disease," or poses a "significant risk of international travel or trade restrictions" [ ] . by this definition, outbreaks must transcend a national border before they legitimately trigger an international response. from the standpoint of national sovereignty, this requirement is understandable. states retain authority to handle health threats purely within their territories. however, the current epidemic began in december , months before it crossed borders into both sierra leone and liberia. this realization should challenge us to reconsider whether national borders should have such clout in considerations of potential global health emergencies. at the very least, the risk of international spread-particularly to other countries with weak public health infrastructures-should be carefully examined to prevent epidemics from growing out of control. a more modern approach to global public health should de-emphasize the a priori criterion of international spread. modeling studies have demonstrated that, for pathogens with relatively short generation times, early cross-border coordination between nations is crucial when epidemic diseases arise in border regions [ ] . but even for diseases with relatively long generation times, as with the current evd epidemic, waiting for cases to cross borders can result in disastrous delays. as such, removing the requirement that an outbreak be an "international threat"-or at minimum interpreting that criterion liberally-will decrease delays between reporting and response and allow much needed support to at-risk countries before epidemics have reached a tipping point. lastly, in hindsight this outbreak might have been defined as a public health emergency long before the who director general (dg) declared it a pheic, and the delay probably exacerbated the slow global response to the outbreak. there are reasons not to prematurely declare a pheic. doing so could damage already vulnerable political systems, lead to misallocation of scarce global health funding, and diminish the influence of the ihr. additionally, a pheic declaration may inadvertently trigger harmful measures, such as border closings and travel bans, which can hinder the response to an epidemic. however, the current epidemic has taught us that delaying an announcement imperils lives and health systems and, in the long run, may do more economic harm [ ] , cost more response dollars, and undermine domestic political legitimacy much more than an early, errant pheic declaration. therefore, for high-consequence diseases of epidemic potential, a precautionary principle should take precedence. the who dg should be empowered to declare pheics early if criteria are met. in fact, the dg has broad discretion to determine when an outbreak constitutes a pheic [ ] . who should interpret this discretion to declare graduated pheics, ranging from high-consequence localized events (e.g., the current ebola outbreak as of june ) to clear global threats (e.g., severe acute respiratory syndrome in ). it can then tailor its recommendations, as well as funding needs, as the scenario unfolds. in doing so, we could expect pheic announcements for outbreaks that never reach devastating proportions. a similar approach has been implemented in other domains-such as genocide prevention-in which a concerted international response is required to prevent urgent problems before they become catastrophic [ ] . in fact, the emergency response framework, also published by who, which aims to grade and motivate responses to international emergencies, public health or otherwise, specifically includes a "no regrets" policy, stating that "it is better to err on the side of over-resourcing the critical functions rather than risk failure by under-resourcing" [ ] . although it garnered relatively less attention than the pheic announcement, who declared the west africa evd epidemic a grade international emergency (the highest classification) on july , two weeks before the pheic was declared [ ] . similar discretion for declaring a pheic might help prevent the next large epidemic from gaining such momentum before the international community responds appropriately. overwhelmed and under-resourced, the affected countries have implemented drastic measures to control the epidemic, including hospital and school closures, local and national quarantines, and border closures [ ] . not surprisingly, these measures have engendered widespread public distrust of health authorities [ ] . in contrast, prior successful responses to ebola [ , ] and other epidemics [ ] have prioritized early partnerships with local authorities, anthropologists, and civil society to establish buy-in from multiple stakeholders. this strategy helps ensure that the design and implementation of control measures are culturally appropriate. in hindsight, some of the negative fallout from decisions to use extraordinary measures might have been avoided had who, in partnership with local community leaders and public health experts, more assertively used their legitimacy to caution against the use of coercive measures without an evidence base. when acting under emergency powers-and especially when using extraordinary control measures such as regional quarantines-governments should prioritize formation of community advisory bodies in the affected region. a rich institutional knowledge about best practices for community advisory boards exists from the research community [ , ] and, in combination with recent experience gained through collaborations with community leaders during the current epidemic, can serve as the basis for much-needed guidelines for public health activities. members should represent divergent interests and include religious leaders, community representatives, nongovernmental organizations (ngos), and other stakeholders. the body should be briefed on the status of the threat and called on to offer recommendations on community desensitization, capacity building, and control measures. while national and local governments hold primary responsibility for creating community advisory bodies, international actors should provide support, including technical assistance for overstretched ministries as they weigh evidence about appropriate interventions. declaring a pheic is a critical early step to marshal an effective response. a pheic announcement alerts partners and should initiate a concerted, coordinated response. but a pheic is of little value without corresponding ammunition. for example, although the pheic was announced on august , six weeks passed between the declaration and the united states government's commitment of us$ million and the planned deployment of , military personnel and public health service commissioned corps officers [ ] . in the interim, total cases of evd increased from approximately , to over , , and confirmed deaths more than tripled, from under , to approximately , [ ] . the steady march of the epidemic, not only before the pheic declaration but also long after it, reinforces the fact that global health preparedness is contingent on the immediate availability of funding and human resources to respond. this need can be fulfilled through the establishment of a global emergency fund and the formation of a corps of trained health workers that can be deployed rapidly to curb an outbreak, with expertise ranging from epidemic surveillance to supply chain management. an international health systems fund, through a sustained investment by global partners, would provide much needed preparedness in future cases of outbreaks in lmics, where local resources are not capable of controlling epidemics [ ] . in , a who committee proposed the establishment of a us$ million contingency fund for rapid response in a declared pheic [ ] . however, the commitment remains unfulfilled. instead, the organization has been forced to rely on mobilizing funding from member states and other partners [ ] , which inevitably delays a robust international response. spurred by the current evd epidemic, in january who's secretariat repeated calls for the creation of a rapid response fund, to be financed by member states [ ] , and who's executive board agreed to establish the fund [ ] . yet, the onus remains on who and the international community to follow through with this request even after the present emergency has faded and ensure this call to action does not meet a similar fate as previous attempts. arguably the greatest lesson to emerge from the ebola virus epidemic is that both national ministries and the global public health community were caught off guard and unprepared [ ] . in addition to the many thousands of lives taken from both ebola infections and interrupted access to routine health services, billions of dollars that could have otherwise been used for development and health systems strengthening were allocated to direct the ebola response. the deleterious impact on local economies is equally staggering. the world bank predicts that the three most affected countries will lose us$ . billion in economic growth in , corresponding to an average gross domestic product (gdp) loss of % across the three countries. in sierra leone, a loss of nearly % of the gdp is projected [ ] . all this resulted from a disease that is relatively easy to control in settings with established health systems. had a disease like sars, with airborne transmission and a high case-fatality rate emerged in a similar location, the fallout could have been far worse. what can be done today to prepare for the unavoidable public health threats of tomorrow? in the long term, it will be essential to build more robust health systems. beyond public health emergencies, strong health systems will improve the health and wellbeing of the population in lmics by delivering a range of essential services [ ] [ ] [ ] . the ihr currently mandate that technical support-surveillance, epidemiology, and laboratory and other core capacities-be provided by high-income countries to low-income countries to build capacity to survey and respond to outbreaks and that a detailed international framework exist for defining and assessing these capacities [ ] . however, although this is a central component of the obligations borne by countries for collective health security, capacity building support to low-income countries has long been underfunded. as a result, most countries in sub-saharan africa continue to suffer from weak systems for disaster preparedness and emergency response [ , ] . to ensure a truly robust response to global health hazards, states must abide by their ihr obligations to build core public health capabilities in regions of need. human resources capacity building, laboratory infrastructure, and epidemiologic surveillance expertise are all urgently needed in west africa and beyond. these inputs should be routinely assessed through a demonstrated capability to deploy resources successfully and in a timely fashion to respond to emergencies [ ] . moreover, such investments clearly will have secondary benefits for routine health services in the areas they are employed. while successful implementation of these elements of the ihr will require substantial resource expenditures by high-resource countries, it is a legal and moral duty to which wealthy countries bound themselves when joining the ihr. the evd epidemic has brought broad realization that health systems strengthening will be crucial to realize the benefits of a global community protected against international infectious disease threats. a positive legacy of the otherwise disastrous evd outbreak should be a global community with renewed commitment to the establishment of a capable emergency response infrastructure. while current efforts to bring the evd epidemic under control should be widely applauded, the delayed response during the early stages of the evd epidemic in west africa exemplifies not only the danger posed by disease outbreaks in states with weak health systems but also their widespread impact in an increasingly globalized world. the international public health community-who, states, and stakeholders-can learn from missteps during the first stages of the epidemic. if instead we accept the status quo by relying on overwhelmed and undersupported domestic health systems and international charity to respond to threats after they have become emergencies, history will repeat itself. at stake are the values of the ihr and the legitimacy of who. the power of global health law and global health institutions will remain seriously unrealized and deeply compromised if the ebola epidemic does not spur fundamental reform. emergence of zaire ebola virus disease in guinea-preliminary report the global response to the ebola fever epidemic: what took so long? speaking of medicine: blogsplosorg/speakingofmedicine: plos medicine ebola response roadmap estimating the future number of cases in the ebola epidemic-liberia and sierra leone what's missing in the ebola fight in west africa ebola virus disease outbreak-nigeria world health organization ( ) international 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international health regulations biosurveillance capability requirements for the global health security agenda: lessons from the h n pandemic key: cord- - lsyh s authors: purgato, marianna; uphoff, eleonora; singh, rakesh; thapa pachya, ambika; abdulmalik, jibril; van ginneken, nadja title: promotion, prevention and treatment interventions for mental health in low- and middle-income countries through a task-shifting approach date: - - journal: epidemiol psychiatr sci doi: . /s x sha: doc_id: cord_uid: lsyh s recently, mental health and ill health have been reframed to be seen as a continuum from health to ill health, through the stages of being asymptomatic ‘at risk’, to experiencing ‘mental distress’, ‘sub-syndromal symptoms’ and finally ‘mental disorders’. this new conceptualisation emphasised the importance of mental health promotion and prevention interventions, aimed at reducing the likelihood of future disorders with the general population or with people who are identified as being at risk of a disorder. this concept generated discussion on the distinction between prevention and treatment interventions, especially for those mental health conditions which lie between psychological distress and a formal psychiatric diagnosis. the present editorial aims to clarify the definition of promotion, prevention and treatment interventions delivered through a task-shifting approach according to a global mental health perspective. the coronavirus pandemic has brought with it not only the physical sequelae of the viral infection but also rising levels of poverty, socioeconomic insecurity and physical and mental health problems worldwide. it is also postulated that the sars-cov virus may have neurological/ neuropsychiatric impact on the brain (holmes et al., ) . now more than ever, with rising mental health needs, it becomes even more important to find an effective solution to providing universal mental healthcare. strategies also need to be rolled out to tackle the root social, economic, environmental and psychological causes of mental ill health to prevent mental disorders and promote wellbeing. mental, behavioural and neuropsychiatric disorders all feature in the top causes of years lived with disability. the highest contributors are anxiety and depressive disorders, drug-use disorders and alcohol-use disorders (dalys and collaborators, ) . mental health and behavioural disorders contribute . % of the global burden of disease in the world, more than, for example, tuberculosis ( . %), hiv/aids ( . %) or malaria ( . %) (whiteford et al., ) . the contribution of major depressive disorders to worldwide disability-adjusted life years has increased by % from to and is predicted to rise further (prince et al., ; murray et al., ) . furthermore, self-inflicted injuries and alcohol-related disorders are likely to increase in the ranking of global disease burden due to the decline in communicable diseases and because of a predicted increase in war and violence. the disease burden due to alzheimer's disease is also increasing, linked to the demographic transition towards an ageing population . people living in low-and middle-income countries (lmics) are exposed to a constellation of stressors that make them vulnerable to developing psychological symptoms and/or mental disorders, and a large gap between individuals in need of care and those who actually receive evidence-based interventions still exists (world health organization, , . conceptualising mental health interventions is particularly relevant in settings with limited resources for interventions implementation. recently, mental health and ill health have been reframed to be seen as a continuum from health to ill health, through the stages of being asymptomatic 'at risk', to experiencing 'mental distress', 'sub-syndromal symptoms' (some symptoms suggested of a mental disorder but not sufficient to reach diagnostic categories) and finally 'mental disorders' (patel et al., ) . this new conceptualisation emphasised the importance of mental health promotion and prevention interventions, aimed at reducing the likelihood of future disorders with the general population or with people who are identified as being at risk of a disorder (tol et al., ) . at the same time, this concept generated discussion on the distinction between prevention and treatment interventions for those mental health conditions which lie between psychological distress and a formal psychiatric diagnosis. the boundary between prevention and treatment is hard to draw in mental health. figure shows how staging has been conceptualised of mental health symptoms, together with where prevention and treatment interventions fit in. for example, wellbeing interventions are not just relevant to those who are asymptomatic as people with mental disorders can still work on and achieve a sense of wellbeing and quality of life and are therefore relevant across the stages (patel et al., ) . furthermore, these stages are not fixed or very well defined. minimal or early distress is a state which can often fluctuate and may not be affecting someone's functioning much yet whereas people with prodromal symptoms may well start to affect their function. in practice, differentiating which populations in the study are in these categories is difficult as the populations are often mixed. this issue is particularly important in lmic settings, where it may not be affordable for mental health specialists (psychiatrists, psychologists) to administer diagnostic instruments (saraceno, ; barbui et al., ). the gap between the individuals in need of mental health interventions and those who actually receive such care remains very large (world health organization, ) . a study of countries with the who mental health surveys found that . % of persons with depressive disorder in lmics received any treatment in the past months, and only . % of persons with depressive disorder received minimally adequate treatment (thornicroft et al., ) . furthermore, the quality of care received by many people, in particular those affected by severe mental disorders and disabilities, was poor in all countries and was often associated with abuses of their fundamental human rights (patel et al., ) . this is despite the existence of a range of cost-effective interventions in mental health care in lmics (tol et al., ; van ginneken et al., ; purgato et al., a purgato et al., , b barbui et al., ) . major barriers to closing the treatment gap are the huge persistent scarcity of skilled human resources, large inequities and inefficiencies in resource distribution and utilisation, limited community awareness of mental health, poverty and social deprivation, and the significant stigma associated with psychiatric illness (barber et al., ) . some papers have advocated for scaling up evidence-based services and for the task-shifting of mental health interventions to non-specialists as key strategies for closing the treatment gap (patel et al., ) . moreover, the world health organization (who) developed the mental health gap action programme intervention guide (mhgap-ig) through a systematic review of evidence followed by an international participatory consultative process. the mhgap-ig comprises straightforward, user-friendly, diagnosis-specific clinical guidelines for providing evidence-based practices for non-specialised health care providers. the mhgap may be adapted for national and local needs, and consider the task-shifting approaches a promising strategy for improving mental health care delivery (world health organization, ) . task-shifting entails the shifting of tasks, typically from more to less highly trained individuals to make efficient use of these resources, allowing all providers to work at the top of their scope of practice. this includes primary care health workers (phws) and community workers (cws). phws are first-level health providers who have received general health training rather than specialist mental health training and can be based in a primary care clinic or in the community. cadres included are professionals (doctors, nurses and other general paraprofessionals) and non-professionals (such as trained lay health providers). phws do not include, for example, psychiatrists, psychologists, psychiatric nurses or mental health social workers. cws such as teachers and community-level workers who have no background health training, but who may perform a particular mental health function within their role, are a further human resource employed in delivering promotion, prevention and treatment interventions . the differences in the organisation of mental health services between lmics and high-income countries (hics), with poorer countries having little or no mental health service structures in primary care or the community, means that the problem of providing mental health care is different in such settings. pws may need to work with little or no support from specialist mental health services and fewer options for referral. consequently, pws interventions might be expected to function differently in many lmics compared with hics. in lmics, phws and cws have been employed in various services, including those delivered by governmental, private and non-governmental organisations in clinics, half-way homes, schools and communities. for example, lay health workers have been involved in supporting carers, befriending, ensuring adherence and delivering simple mental health interventions . nurses, social workers and cws may also take on follow-up or educational/promotional roles (araya et al., ; chatterjee et al., ; chatterjee et al., ) . in addition, doctors with general mental health training have been involved in the identification, diagnosis, treatment and referral of complex cases . teachers and other educational support staff have been an important resource for child mental health care (dybdahl, ; gordon et al., ; shen et al., ) and for the delivery of prevention interventions (ager et al., ) . the task-shifting approach is being used across a wide range of mental conditions in lmics and has increasing evidence of being effective (van ginneken et al., update in progress) , though still only a small percentage of psychological interventions in lmics actually include nonspecialists as providers (fig. ) . promotion is an approach aimed at strengthening positive aspects of mental health and psychosocial wellbeing, and is focused on empowering people to live healthy lives (e.g. by facilitating healthy lifestyles through policies, such as providing nutritious foods in school canteens or opportunities for physical exercise in accessible locations), rather than health being the sole domain of health professionals (national research council and institute of medicine, ). it includesfor examplecomponents to foster pro-social behaviour, self-esteem, coping, decision-making capacity, but also universal interventions such as social and economic interventions to improve people's social determinants of health which would impact on their wellbeing. prevention is an approach aimed at reducing the likelihood of future disorder in the general population or for people who are identified as being at risk of a disorder (eaton, ; tol et al., ) . prevention is further subdivided on the basis of the population targeted, into universal, selective and indicated (national research council and institute of medicine, ). universal prevention, which includes strategies that can be offered to the whole population including individuals who are not at risk, based on the evidence that it is likely to provide some benefit to all (reduce the probability of disorder), clearly outweighs the costs and risks of negative consequences. examples of common universal prevention interventions include the community-wide provision of information on positive coping methods (iasc, ) to help people feeling safe and hopeful, protection against human rights violations (e.g. gender-based violence), community-wide efforts to improve livelihoods as a key protective factor for mental health. selective prevention refers to strategies that are targeted to subpopulations identified as being at elevated biological, social or psychological risk for a disorder but who are asymptomatic or have very minimal symptoms. these interventions involve human, supportive and practical help covering both a social and a psychological dimension. they work through communication (asking about people needs and concerns; listening to people and helping them to feel calm), practical support (i.e. providing meals or water) and with a psychological approach including teaching stress management skills and helping people to cope with problems (world health organization, ); facilitation of community support for vulnerable individuals by activating social networks and communication; structured cultural and recreational activities supporting the development of resilience (national research council and institute of medicine, ), such as traditional dancing, art work, sports and puppetry. these activities may take place in equipped settings with the aim of increasing the children's sense of connectivity and safety (tol et al., ) . indicated prevention includes strategies that are targeted to individuals who are identified (or individually screened) as having detectable signs or symptoms which can foreshadow, precede and may sometimesif left unaddressedlead to a full diagnosable mental disorder based on an individual assessment. these interventions to prevent mental disorders may be delivered at individual or group level, in a variety of settings (antenatal and postnatal visits, home visits, community settings, schools, etc.). these interventions include psychosocial support for persons with subclinical levels of mental disorders (purgato et al., a) , such as mentoring programmes aimed at children with behavioural problems; psychological first aid for people with heightened levels of psychological distress after exposure to severe stressors, loss or bereavement (tol et al., ) . this includes facilitator-guided self-help group interventions, as for example the who self-help plus (epping-jordan et al., ; purgato et al., a) . unlike hics, in lmics, factors as the socioecology of poverty, malnutrition, political conflicts, lack or poor implementation of mental health policy, poor governance in mental health and health systems, and lower priority for mental health influence the epidemiology, outcomes and treatment strategies of mental health problems (yasamy et al., ; baingana et al., ) . treatment interventions are delivered to people who have a diagnosed mental disorder. however, sometimes, these treatment interventions, particularly psychological or psychosocial interventions, are also considered as effective treatments for those population groups that may receive 'indicated prevention' interventions in the category above. from the lancet commission on global mental health (which reconceptualised mental illness symptoms along a transdiagnostic staged spectrum), there is some evidence that treatments for mental disorders can overlap and be as effective for those with prodromal symptoms as for those with a diagnosable mental disorder (patel et al., ) . treatment interventions include various forms of psychotherapy and/or pharmacological treatment. in addition, treatment interventions may include broader interventions sometimes delivered by phws or cws (and sometimes by specialist psychiatric nurses) such as training in self-help interventions, informal support, transdiagnostic psychosocial support (individualised plan addressing social and emotional functioning and problems) and high-risk individual identification which may be particularly relevant to those who have detectable subthreshold signs and symptoms of mental illness (van ginneken et al., ) . long-term interventions are important to help rehabilitate people after acute mental disorders, maintain stable mental health for those with chronic mental disorders and prevent recurrence or relapse. these could include roles in follow-up or rehabilitation of people with chronic severe mental disorders, and roles in detecting and dealing with relapse/recurrence, compliance issues, treatment resistance, side effects of treatment or psychosocial problems (patel et al., ) . these may be individual or combined interventions, delivered either as a simple contained group of sessions, or as a complex collaborative care provision following a stepped care protocol or a shared care between primary care and specialist care (van ginneken et al., ; barbui et al., ) . despite the conceptual similarities and growing evidence for mental health promotion, prevention and treatment interventions may share conceptual similarities across the world and have growing evidence, delivering these interventions in lmics is bound with several challenges. the acceptability of interventions might also be different, especially as for distressed participants who do not present an established psychiatric diagnosis dealing with their psychological distress may not be a high priority as dealing with other social or health issues. participants (and their families) with a mental disorder, by contrast, may recognise that dealing with psychological problems is a high priority and a pre-requisite for optimal social functioning, thus showing more compliance and participation in psychological interventions. many lmics either lack or are poor in implementation of mental health policies, programmes and interventions and have difficult access to mental health care (alloh et al., ) . a key factor attributing to mental health issues in lmics is the discrimination against people suffering from mental illnesses where often they are labelled, exempted and even abused (alloh et al., ) . henceforth, people in lmics are often reluctant to seek mental healthcare services to avoid the circumstances where they are socially discriminated. the condition is further aggravated in many lmics where people identified with mental health problems experience stigma even during treatment, which in turn leads to poor care, delay in seeking health services or nonadherence to treatments (alloh et al., ) . 'for an instance, it is a very common myth that people suffering from mental illness rarely get recovered in south western nigeria' (orngu, ) . additionally, the coordination and management of mental health interventions in humanitarian settings including conflicts, disasters, epidemic and pandemic may present major challenges. for example, despite an increase in the incidence of mental health problems during armed conflicts, earthquakes, epidemics and famine in countries like nepal, haiti and ethiopia, the limited resources are diverted to areas other than mental health (rathod et al., ) . there may also be many different socio-economic factors which influence the burden of mental health. in many lmics, social factors such as poverty, gender, urbanisation, internal migration and lifestyle changes are moderators of the magnitude of mental health problems (rathod et al., ; wainberg et al., ) . furthermore, low levels of knowledge regarding mental health problems have been suggested as an important factor that delays the interventions' onset (henderson et al., ) . finally, the resources for delivery and training, and the types of cadres of health workers involved increase heterogeneity across interventions, which become difficult to compare. training, supervision and competency assessment of those delivering these interventions have also traditionally not been priorities in lmic due to scarce human and financial resources (though these have become increasingly addressed features of lmic trials) marianna purgato et al. (kakuma et al., ) and limited dissemination and implementation research capacity (wainberg et al., ) . despite research in global mental health rapidly growing, with rigorous studies implemented in lmic settings, there remain several research challenges to be addressed. mental ill health is globally recognised as one of the major public health problems yet mental health care and promotion/prevention are less prioritised in many lmics (alloh et al., ) . furthermore, there are various difficulties that are faced by mental health researchers in lmics including lack of good mental health research governance, lack of funding, shortage of trained personnel to carry out mental health research, unequal distribution of mental health research capacity, difficulty in training due to weaker institutional infrastructure, constraints on investigators' time owing to healthcare delivery and teaching responsibilities, absence of a strong research 'culture', poor peer networks and collaborations (the academy of medical sciences, ; yasamy et al., ) . moreover, there are other practical problems and context-dependent issues that hinder mental health research in lmics. for example, low mental health literacy among the larger research community and frequent migration make large-scale intervention trials and prospective studies a challenge (yasamy et al., ) . given the magnitude of the burden of mental disorders, although treatment intervention alone will not be enough to close the mental health gap in lmics, mental health promotion and prevention of mental illness are at an incipient stage in most lmics (wainberg et al., ) . although difficult to achieve in lmics, decreasing structural inequality, stigma and social discrimination is an important prevention intervention targeted towards mental illnesses. current evidence is insufficient to determine what prevention interventions are effective and feasible for decreasing stigma in lmics, how best to target key groups such as health care staff, and how to adapt such interventions in specific contexts (wainberg et al., ) . one of the complexities with research interventions delivered in lmics is that asymptomatic, prodromal and/or disordered populations overlap within the same experimental study. there is variation in the categorising of interventions and/or population groups as belonging to the treatment or various prevention categories. in practical terms, it means that experimental studies may include participants showing no distress, some psychological distress and/or participants with a formal psychiatric diagnosis. this is due often to not having the setting, tools, manpower or not felt appropriate to select people based on screening tools, but rather based on situational settings a much more immediate and tangible inclusion criterion particularly in difficult settings like war-torn or highly deprived settings. mixed population groups are thus likely to increase heterogeneity, as the clinical response and compliance to interventions may vary. in this scenario, subgroup analyses based on participant symptom stage may be a strategy to evaluate interventions' efficacy. the 'grey area' between treatment and prevention, i.e. the indicated prevention, is often difficult to categorise as their aims can be to either treat participants to reduce their symptoms or help them recover, or to prevent the development of mental disorder. whilst categorising these interventions to decide which of the parallel systematic reviews on treatment and prevention interventions (both ongoing) they would fit in, we divided these studies according to these expected aims and outcomes. studies where the intervention aim was to achieve recovery or symptom improvement were included in the treatment review (van ginneken et al., update in progress) . those aimed at preventing mental disorders went into the prevention review . several studies were difficult to discern and needed to be included in both reviews due to uncertainty of mixed populations. once these reviews are completed we may be able to produce more specific guidance on whether this strategy worked and how. furthermore, the choice of control group is relevant for research in lmics and may have clinical implications. in many lmics, participants suffer from long-lasting and even chronic conditions because they lack the possibility of receiving appropriate evidence-based treatments (purgato et al., b) . despite the waiting list as a control condition has been criticised because of limiting participants seeking care for their mental condition elsewhere because they are waiting for the intervention (cuijpers and cristea, ; cuijpers et al., ) , this is less of a concern in many lmics, in which often the alternative is simply not receiving care at all. even the control group defined as treatment as usual (tau) may vary according to populations and contexts, to the point that being in the tau condition sometimes corresponds to not getting treatments at all and differentiating tau from no treatment or from waiting list control might become difficult. we do not intend to provide a conclusive or simplistic framework for categorizing mental health interventions in lmics. however, clarifying key concepts of relevance to public mental health and how it is intertwined with task-shifting to expand universal access, may help both researchers and practitioners in the design, assessment and implementation of evidence-based interventions. financial support. none. conflict of interest. none. the impact of the school-based psychosocial structured activities (pssa) program on conflict-affected children in northern uganda mental health in low-and middle income countries (lmics): going beyond the need for funding treating depression in primary care in low-income women in global research challenges and opportunities for mental health and substance-use disorders microaggressions towards people affected by mental health problems: a scoping 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countries challenges and opportunities in global mental health: a research-to-practice perspective global burden of disease attributable to mental and substance use disorders: findings from the global burden of disease study intervention guide for mental, neurological and substance use disorders in non-specialized health settings: mental health gap action programme (mhgap) intervention guide for mental, neurological and substance use disorders in non-specialized health settings: mental health gap action programme (mhgap) world health organization, war trauma foundation, and world vision international ( ) psychological first aid: guide for field workers responsible governance for mental health research in low resource countries key: cord- -ew n i z authors: nambiar, devaki; sankar, hari; negi, jyotsna; nair, arun; sadanandan, rajeev title: field-testing of primary health-care indicators, india date: - - journal: bull world health organ doi: . /blt. . sha: doc_id: cord_uid: ew n i z objective: to develop a primary health-care monitoring framework and health outcome indicator list, and field-test and triangulate indicators designed to assess health reforms in kerala, india, – . methods: we used a modified delphi technique to develop a -item indicator list to monitor primary health care. we used a multistage cluster random sampling technique to select one district from each of four district clusters, and then select both a family and a primary health centre from each of the four districts. we field-tested and triangulated the indicators using facility data and a population-based household survey. findings: our data revealed similarities between facility and survey data for some indicators (e.g. low birth weight and pre-check services), but differences for others (e.g. acute diarrhoeal diseases in children younger than years and blood pressure screening). we made four critical observations: (i) data are available at the facility level but in varying formats; (ii) established global indicators may not always be useful in local monitoring; (iii) operational definitions must be refined; and (iv) triangulation and feedback from the field is vital. conclusion: we observe that, while data can be used to develop indices of progress, interpretation of these indicators requires great care. in the attainment of universal health coverage, we consider that our observations of the utility of certain health indicators will provide valuable insights for practitioners and supervisors in the development of a primary health-care monitoring mechanism. under the thirteenth general programme of work and the triple billion targets, the world health organization (who) aims to increase the number of people benefitting from universal health coverage (uhc) by one billion between and . central to this effort is the expansion and improvement of primary health-care services. , progress in achieving uhc can be analysed using the who and world bank's uhc monitoring framework, , but this requires adaptation to local contexts to ensure health reforms keep pace with targets. health programmes in india, as well as the national health policy and flagship ayushman bharat scheme, are being evaluated in relation to the aims of uhc; various efforts are currently underway at both a national and state level, notably in haryana and tamil nadu. according to national sample survey estimates from - , morbidity levels in the southern state of kerala are reportedly four times the national average with disparities by sex and place of residence. although the state has made gains in maternal and child health, it must sustain these gains while addressing the substantial and growing burden of hypertension, diabetes and cancer; vaccine-preventable diseases; , and emerging viral infections such as nipah virus and severe acute respiratory syndrome coronavirus (sars-cov- ). [ ] [ ] [ ] kerala has been subject to unregulated privatization and cost escalation, resulting in persistent inequalities in service access and health attainment between population subgroups. in , the government of kerala announced aardram, a programme of transformation of existing primary health centres to family health centres; with increased staffing, these family health centres provide access to a greater number of services over longer opening hours compared with the original primary health centres. apart from the who's monitoring framework, many countries have done uhc and primary health centre monitoring exercises , alongside independent exercises such as the primary health care performance initiative. however, most of these frameworks are intended for global comparison or decision-making at national levels. the argument for tracking health reforms is clear, but such a monitoring process must be specific to kerala and local decision-making, while also complying with national and global reporting requirements. periodic household surveys offer population-level data, but are not frequent enough to inform ongoing implementation decisions. routinely collected and disaggregated health system data are vital, but are often marred by quality issues as well as technological and operational constraints. we began a -year implementation research study assessing equity in uhc reforms in january . in our first two phases we aimed to develop a conceptual framework and a health outcome indicator shortlist, followed by validation of these indicators using data from both health facilities and a population-based household survey. we report on the fieldtesting and triangulation components of this implementation research project, which took place during and . we reflect on early lessons from the field-testing and triangulation and, drawing broadly from ostrom's institutional analysis and development framework, we emphasize how monitoring can support learning health systems. , we also discuss how the monitoring of uhc progress requires a flexible approach that is tailored to the local political economy. [ ] [ ] [ ] objective to develop a primary health-care monitoring framework and health outcome indicator list, and field-test and triangulate indicators designed to assess health reforms in kerala, india, - . methods we used a modified delphi technique to develop a -item indicator list to monitor primary health care. we used a multistage cluster random sampling technique to select one district from each of four district clusters, and then select both a family and a primary health centre from each of the four districts. we field-tested and triangulated the indicators using facility data and a population-based household survey. findings our data revealed similarities between facility and survey data for some indicators (e.g. low birth weight and pre-check services), but differences for others (e.g. acute diarrhoeal diseases in children younger than years and blood pressure screening). we made four critical observations: (i) data are available at the facility level but in varying formats; (ii) established global indicators may not always be useful in local monitoring; (iii) operational definitions must be refined; and (iv) triangulation and feedback from the field is vital. conclusion we observe that, while data can be used to develop indices of progress, interpretation of these indicators requires great care. in the attainment of universal health coverage, we consider that our observations of the utility of certain health indicators will provide valuable insights for practitioners and supervisors in the development of a primary health-care monitoring mechanism. research field-testing of health-care indicators, india devaki nambiar et al. we began with a policy scoping exercise for the state of kerala in . we then created an -indicator longlist from existing primary health-care monitoring inventories, , [ ] [ ] [ ] [ ] and undertook an extensive data source and mapping exercise, adapting a process previously conducted in the region. we applied a modified delphi process in two rounds, consulting key health system stakeholders of the state (frontline health workers, primary care doctors, public health experts and policymakers), and obtained a shortlist of indicators (available in the data repository). we then field-tested and triangulated some of the indicators using facility-based data (phases and ) and a population-based household survey (phase ). in phase (december ) we selected three family health centres in coastal, hilly and tribal districts (trivandrum, idukki and wayanad, respectively) of the state. we communicated the definitions and logic of the indicators to facility staff, and studied their data-recording methods to synergize our processes with theirs. from these initial steps, we prepared a structured data collection template (available in the data repository) that we provided to the three family health centres. based on inputs from phase and a second round of consultations with state-level programme officers, we refined the indicator list. in phase (june-october ), we used a multistage random cluster sampling technique to generate data related to the indicators at the population and facility level. we applied principal component analysis using stata version (statacorp, college station, united states of america) to data from the latest national family health survey ( - ) to categorize districts into one of four clusters according to health burden and systems performance. using an opensource list randomizer from random. org, we randomly selected one district from each of the four clusters, and then randomly selected both a primary and a family health centre from each of the four selected districts. the people served by these eight health facilities were the population of interest in our study. we held on-site meetings with the staff of the eight health facilities and provided them with excel-based templates (microsoft corporation, redmond, united states of america) to input data for the financial year march -april (data repository). data were sourced from manual registers maintained at facilities. in addition to off-site coordination, we also provided data-entry on-site support to the health staff, visiting each facility at least four times between may and december . we compiled data from the facilities to obtain annual estimates for all health outcome indicators using excel. our sample size estimation was based on the proportion of men and women eligible for blood pressure screening under the national primary care noncommunicable disease programme, that is, those aged years or older. we estimated a sample size using routine data reported by the noncommunicable disease division of the kerala health and family welfare department ( - ), aiming at a precision of % at a % confidence interval (ci), with a conservative design effect of (i.e. a doubling of the sample). health facility catchment areas were grouped by wards, also referred to as primary sampling units. eligible households within a primary sampling unit had at least one member aged years or older. individual written informed consent was sought from each participant before administration of the survey. we employed and trained staff to collect data using hand-held electronic tablets with a bilingual (english and malayalam) survey application. the survey, conducted during june-october , included questions on sociodemographic parameters, health outcome indicators (e.g. noncommunicable disease risk behaviours and screening; awareness of components of aardram and family health centre reform) and financial risk protection (e.g. out-ofpocket expenditure). national family health survey (round iv) state level weights were applied during analysis. we compared data on selected indicators using stata and excel. since our focus was on how indicators were being understood and reported across facilities, we did not expect indicators to directly correspond between facilities and households, but only to approximate each other. all components of the study were approved by the institutional ethics committee of the george institute for global health (project numbers / and / ). we obtained data from health facilities in total (seven family health centres and four primary health centres) during phases and . during phase , we acquired facility data on indicators from eight health facilities (four family, four primary) jointly serving a population of ( table ). the household survey was undertaken in the catchment areas of these facilities, and we acquired data from a representative sample of individuals in households (table ) . we observed both variations between and uniformity in the indicators from health facilities and the household survey (table ). in studying these patterns, we made four key observations (box ). first, the method of reporting our indicators varied between facilities, even although all raw data required to calculate selected indicators were present in manual registers. in the case of indicators related to national programmes (e.g. reproductive, child health and tuberculosis-related indicators), data were uploaded directly to national digital portals without any analysis at the facility level; officers responsible for data compilation and analysis exist only at the district level. feedback from facility staff included requests for adequate training on new or revised reporting systems, and clarification of their role. this situation may improve with the complete digitization of health records under kerala's e-health programme. our second observation is that there exist two problems with the globally recommended indicators: (i) manual routine data reporting at the facility level may be inadequate to construct the global indicator precisely; and (ii) globally relevant data may not be considered relevant to the periodicity (monthly) or level (facility) of review. from the facility-level data, the cover- field-testing of health-care indicators, india devaki nambiar et al. age of antenatal care reported by family health centres was . % ( / ); in household surveys, full coverage of antenatal care was observed for . % ( / ) of eligible women (table ) . here, antenatal care refers to women aged - years having a live birth in the past year and receiving four or more antenatal check-ups, at least one tetanus toxoid injection, and iron and folic acid tablets or syrup for at least days as numerator. the coverage rate is calculated from a denominator of the total number of women aged - years who had a live birth in the past year, which requires retrospective verification of antenatal coverage. however, in some facilities, the antenatal care coverage indicator was calculated using the previous year's number of deliveries plus % as the denominator, and the number of pregnant women who had received antenatal care as the numerator. it was therefore not always clear that the data from any particular individual were included in both the numerator and denominator and, with a target as the denominator, coverage could surpass %. practitioners noted the disconnect between monthly target-based reporting and annual retrospective measurement. our third observation is that definitions and reporting that reflect actual health-provision patterns require to be standardized; otherwise, discrepancies will be observed between data sets. for example, the indicator for acute diarrhoeal diseases among children younger than years was . % ( / ) according to facility records; however, a prevalence of more than times this percentage ( . %; / ; % ci: . - . ) was reported in the household survey (table ) . several chronic care indicators, newly introduced as part of the introduction of family health centres, also showed discrepancies. for instance, the percentage of people screened for blood pressure and blood glucose was . % ( / ; % ci: . - . ) and . % ( / ; % our fourth observation is that such triangulation exercises, as well as obtaining feedback from health workers, programme managers and administrators, are vital for accurate assessment of uhc coverage. a major problem reported by staff and officials is that health facility data are usually just a tally of patient visits, which is simple to produce, as opposed to the actual number of (potentially repeat) patients receiving care or services. state officials have been encouraging a move towards electronic health records to generate more precise indicators, but adoption and integration of these will only be possible when the technology itself is better aligned to facility-level process flows, requiring user inputs, investment and time. other issues raised include: the need for appropriate staff (including temporary contractual staff) training in programme guidelines and reporting requirements; the need for clarity in definitions of treatment (e.g. chronic disease patients may be advised to modify lifestyle factors, which would be missed if treatment monitoring included only those prescribed medication); and the availability of free or subsidised tests relevant to disease control that are reflected in monitoring indicators, particularly for chronic care (e.g. glycated haemoglobin tests for diabetes care ) at the primary health centre level. as already observed in india and other low-and middle-income countries, our results indicate that any approach to improving or monitoring the quality of health-care must be adaptable to local methods of data production and reporting, while ensuring that emerging concerns of local staff are considered. although validity checks are a staple of epidemiological and public health research, such triangulation processes in health systems are infrequent. the every newborn-birth study was a triangulation of maternal and newborn healthcare data in low-and middle-income countries, and some smaller-scale primary-care indicator triangulation exercises have been undertaken by india's national health systems resource centre. , while there exists a variety of approaches to monitoring primary health-care reforms, we consider the most appropriate to be the generation (and modification, if necessary) of indicators from routine data, and their triangulation with household survey data. increasingly, routine data are being digitized to improve accessibility and interpretation, as is the case in kerala. useful considerations when introducing digital health interventions in low-and middle-income countries are intrinsic programme characteristics, human factors, technical factors, the health-care ecosystem and the broader extrinsic ecosystem. our observations demonstrate the continuous and complex interplay between these characteristics; the real value of selected indicators may also be determined by how staff understand and interpret them. our study had several limitations. our indicator selection using the delphi method could have undergone additional rounds, but we considered it more important to get the monitoring process underway and reduce the burden on health workers. some facility-based information could not be acquired due to the additional health department burden of flood relief and nipah outbreak management in the state. our household survey sample was the population aged years and older, resulting in undersampling for other indicators being fieldtested (e.g. newborn low birth weight). an increase in sample size could allow a more precise estimation of all indicators. finally, the reference periods for the facility data and the household survey did not directly overlap; a timed sampling should be undertaken in the future to improve the precision of triangulation. observing the utility of indicators in practice is a key first step in the move towards uhc, requiring investment and commitment. using indicators, standards and other forms of technology, which are easy to adopt, can be problematic because we amplify certain aspects of the world while reducing others. our examination of family health centre reforms cautions that, while data can be used to develop indices of progress, interpretation of these indicators requires great care precisely because of the way they are related to powerful decisions around what constitutes success or failure, who will receive recognition or admonition and, ultimately, the legacy of aardram reforms. we anticipate that our observations will contribute to healthcare reforms in low-and middle-income countries, such as the use of field triangulation to enhance the accountability and relevance of global health metrics. if such activities are carried out in constructive partnerships with state stakeholders and do not introduce unfeasible costs to the system, they may contribute to a sustained and reflexive monitoring process along the path to uhc. ■ observation : data are available at the facility level, but in varying formats and platforms meant for different purposes; digitization may improve this situation. observation : established global indicators may not be useful or interpreted as intended in a local context, and may need to be adapted. observation : operational definitions, thresholds for interpretation and processes of routine data collection must be refined for older indicators and developed for newly introduced indicators. observation : triangulation and feedback from the field level, with qualitative input from local actors, remains vital, particularly for chronic diseases. field-testing of health-care indicators, india devaki nambiar et al. Цель Разработать систему мониторинга первичной медикосанитарной помощи и перечень показателей конечных результатов в отношении здоровья, а также провести тестирование на местах и всесторонне рассмотреть показатели, предназначенные для оценки реформ здравоохранения в штате Керала, Индия, в - гг. Методы Авторы использовали модифицированный «дельфийский» метод для разработки перечня показателей, состоящего из пунктов, с помощью которого осуществлялся мониторинг первичной медико-санитарной помощи. Авторы использовали метод многоступенчатой кластерной случайной выборки, чтобы отобрать один район в каждом из четырех районных кластеров, а затем таким же образом выбирали семью и центр первичной медико-санитарной помощи в каждом из четырех районов. Авторы испытали на местах и всесторонне оценили показатели с использованием данных учреждений и анкетирования домохозяйств на уровне популяции. Результаты Полученные данные выявили сходство между данными учреждений и данными анкетирования по одним показателям (например, низкая масса тела при рождении и услуги предварительной проверки), но различия по другим показателям (например, острые диарейные болезни у детей младше лет и скрининг артериального давления). Авторы составили четыре важных замечания: (i) данные доступны на уровне учреждения, но в различных форматах; (ii) определенные глобальные показатели не всегда могут использоваться для местного мониторинга; (iii) практические определения требуют уточнения; (iv) всестороннее рассмотрение и обратная связь с мест критически важны. Вывод Наблюдения говорят о том, что, хотя данные можно использовать для разработки индексов прогресса, интерпретация этих показателей требует большой осторожности. В достижении всеобщего охвата услугами здравоохранения авторы считают, что их наблюдения о полезности определенных показателей здоровья дадут ценную информацию для практикующих врачей и руководителей при разработке механизма мониторинга первичной медико-санитарной помощи. objetivo elaborar un marco de supervisión de la atención primaria de salud y una lista de indicadores sobre los resultados en la salud, así como realizar ensayos de campo y triangular los indicadores previstos para evaluar las reformas sanitarias en kerala, india, - . métodos se aplicó un método delphi modificado para elaborar una lista de indicadores que incluye elementos para supervisar la atención primaria de salud. además, se empleó una técnica de muestreo aleatorio por conglomerados de etapas múltiples para seleccionar un distrito de cada uno de los cuatro conglomerados de distritos y, a continuación, se seleccionó una familia y un centro de atención primaria de cada uno de los cuatro distritos. se realizaron ensayos de campo y se triangularon los indicadores mediante el uso de datos de los centros y una encuesta domiciliaria basada en la población. resultados los datos obtenidos revelaron similitudes entre los datos de los centros y los de las encuestas para algunos indicadores (por ejemplo, el peso bajo al nacer y los servicios de control previo), así como diferencias para otros (por ejemplo, las enfermedades diarreicas agudas en niños menores de años y la evaluación de la presión arterial). se formularon cuatro observaciones críticas: i) los datos están disponibles a nivel de los establecimientos, pero en distintos formatos; ii) los indicadores globales establecidos no siempre son útiles para realizar una vigilancia local; iii) las definiciones operativas se deben perfeccionar; y iv) la triangulación y las observaciones en el terreno son vitales. conclusión se observa que, si bien los datos se pueden usar para elaborar índices de progreso, la interpretación de estos indicadores requiere gran atención. se cree que las observaciones obtenidas sobre la utilidad de ciertos indicadores de salud permitirán a los profesionales y a los supervisores comprender mejor el desarrollo de un mecanismo de vigilancia de la atención primaria de salud para lograr la cobertura sanitaria universal. geneva: world health organization the astana declaration: the future of primary health care? lancet geneva: world health organization tracking universal health coverage: global monitoring report. geneva: world health organization primary health care on the road to universal health coverage monitoring and evaluating progress towards universal health coverage in india new delhi: government of india, ministry of health and family welfare ayushman bharat -national health protection mission new delhi: niti aayog, national institution for transforming india, government of india a composite indicator to measure universal health care coverage in india: way forward for post- health system performance monitoring framework. health policy plan universal health coverage-pilot in tamil nadu: has it delivered what was expected? chennai: national health mission -tamil nadu field-testing of health-care indicators key indicators of social consumption in india: health | national sample survey th round health inequalities in south asia at the launch of sustainable development goals: exclusions in health in kerala, india need political interventions india state-level disease burden initiative diabetes collaborators. the increasing burden of diabetes and variations among the states of india: the global burden of disease study india state-level disease burden initiative cancer collaborators. the burden of cancers and their variations across the states of india: the global burden of disease study - 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cbnip a authors: zeng, bin; chen, di; qiu, zhuoying; zhang, minsheng; wang, guoxiang; wang, jianye; yu, pulin; wu, xianguang; an, bingchen; bai, dingqun; chen, zhuoming; deng, jingyuan; guo, qi; he, chengqi; hu, xiquan; huang, chongxia; huang, qiuchen; huang, xuming; huang, zhen; li, xinping; liang, zhongming; liu, gang; liu, peng; ma, chao; ma, hongzhuo; mi, zhongxiang; pan, cuihuan; shi, xiue; sun, hongwei; xi, jianing; xiao, xiaofei; xu, tao; xu, wuhua; yang, jian; yang, shaohua; yang, wanzhang; ye, xiangming; yun, xiaoping; zhang, aiming; zhang, chong; zhang, pande; zhang, qiaojun; zhao, mingming; zhao, jiejiao title: expert consensus on protocol of rehabilitation for covid‐ patients using framework and approaches of who international family classifications date: - - journal: aging med (milton) doi: . /agm . sha: doc_id: cord_uid: cbnip a coronavirus disease (covid‐ ) has widely spread all over the world and the numbers of patients and deaths are increasing. according to the epidemiology, virology, and clinical practice, there are varying degrees of changes in patients, involving the human body structure and function and the activity and participation. based on the world health organization (who) international classification of functioning, disability and health (icf) and its biopsychosocial model of functioning, we use the who family of international classifications (who‐fics) framework to form an expert consensus on the covid‐ rehabilitation program, focusing on the diagnosis and evaluation of disease and functioning, and service delivery of rehabilitation, and to establish a standard rehabilitation framework, terminology system, and evaluation and intervention systems based the who‐fics. . the icf has established a unified and standardized terminology system to classify the functioning and disability. it is the fundamental system of physical medicine and rehabilitation and is recommended in the fields of diagnosis and coding, evaluation, and interventions of functioning to maximize patients' functioning at three levels: ( ) body function and structure; ( ) activity and participation; and ( ) environmental factors and personal factors. the ichi provides a set of general classifications to report and analyze the evaluation and health interventions. it is applicable to all health system levels and uses the same structure and terminology as the icf to describe health interventions. the icd is used for disease diagnosis and coding; the icf is used for description, evaluation, and coding of functioning; and the ichi is used for intervention and coding of functioning. the ichi is consistent with the icd- and icf in ontological structure and terminology. , [consensus ] this consensus adopts the framework and approach of who-fics to build a rehabilitation protocol of covid- disease diagnosis, description and evaluation, coding and intervention of functioning (see table ). [consensus ] the who recommends three standardized functional assessment tools based on the icf in icd- , namely the who disability assessment schedule . (whodas . ), the brief model disability survey, and the generic functioning domains (vb ). the functional evaluation based on the icf, such as icf-core set, can be used for patients' overall functional assessment, rehabilitation-needs assessment, and rehabilitation-outcome assessment. this consensus recommends the use of these three standardized assessment tools in rehabilitation evaluation. the qualifiers of icf can be used to standardize the results of functional assessment in the field of rehabilitation to achieve comparable international functional data. according to the icf, this consensus also recommends all evaluations mapped to icf structure involve in four aspects: body function and structure, activity and participation, environmental factors and personal factors. [ ] [ ] [ ] [ ] [ ] [ ] according to the framework and scope of rehabilitation developed by the international society of physical and rehabilitation medicine (isprm white paper), icf and ichi β- , we develop a personalized intervention plan based on specific unmet needs of patients with covid- . delivery system based on icf and who guideline: rehabilitation in health system. , [ ] [ ] [ ] [ ] in light of the who rehabilitation guideine: rehabilitation in health system, rehabilitation for covid- survivors should be provided at tertiary-, secondary-, and primary-care levels and integrated into the continuum of prevention, treatment, rehabilitation, and health promotion. [consensus ] according to the recommendations from who guidelines rehabilitation in health system, considering the functioning caused by covid- , including mental health issues and environmental support factors, we should implement the people-oriented rehabilitation throughout lifespan and concerns social determinants, adopt multidisciplinary and cross-domain approaches, and with approaches of universal design to bulid barriers-free environments and to establish a comprehensive rehabilitation service system. the new coronavirus is a coronavirus of β genus, with a capsule, round or oval particles, often pleomorphic, with a diameter of - nm. [ ] [ ] [ ] the virus is sensitive to uv; and heat of °c for minutes, ether, % ethanol, chlorine containing disinfectant, peracetic acid, and chloroform can effectively inactivate the virus. chlorhexidine cannot effectively inactivate the virus. the novel coronavirus is the main source of infection. asymptomatic infections can also be a source of infection. the main route of transmission is through respiratory droplets and close contact. it is possible to propagate through aerosols when exposed to high-concentration aerosols for a long time in a relatively closed ta b l e protocol of rehabilitation for covid- cases using the who-fics the results of a lung biopsy and autopsy in a covid- patient showed that the patient had pleural effusion, pleural thickening, and extensive and severe adhesion with the lung. the lung tissue showed dark red and gray white patchy changes in toughness, while a large amount of gray white viscous fluid overflowed in the lung tissue, and fiber cords were seen. white foam mucus was seen in the endotracheal tube, and mucus adhered in the lumen of the right pulmonary branch. the main manifestations of patients are fever, dry cough, and fa- it is necessary to establish a multi-disciplinary rehabilitation team for patients with covid- . according to the functioning characteristics and the rehabilitation stage of patients, individualized rehabilitation intervention strategies and approached are recommended. , from the current situation of the cases, most patients have a good prognosis, and a few patients are in a critical condition. the prognosis of the elderly and those with chronic basic diseases is poor. the symptoms of children are relatively mild. mild: the clinical symptoms are mild, and no pneumonia is found in radiology. moderate: fever, respiratory tract and other symptoms are present, and pneumonia is found in radiology. severity: those complying with any of the following should be ( ) radiology shows that the lesions progress more than % in a coding protocol of covid- with icd- had been issued by national health and health commission and national health insurance bureau. the "u . " code is used for novel coronavirus as a statistical code for all confirmed covid- cases. it is not used as a main diagnostic code for the front page of the medical record. the "u . x : novel coronavirus pneumonia" code is only applicable to the "confirmed inpatients with new coronavirus pneumonia" and must be used as the main diagnostic encode. the code is defined as follows: ( ) [consensus ] covid- cases have secondary functioning and disability. using the rapid extended icf core set, we can describe, evaluate, and code the functioning of cases with covid- . this rapid icf core set developed from icf core set for copd. see table for description and coding demonstration case. [consensus ] according to the disease classification, functional status, and rehabilitation needs of patients with covid- , the following rehabilitation assessment and evaluation are recommended. as novel coronavirus is highly infectious and highly pathogenic, the icf core set is a widely used standardized tool. there is no icf core set for covid- . we recommend a rapid and extended icf core set from icf core set for copd for evaluation and description of functioning and disability for covid- cases (table ). according to the covid- -cases-related body functions and structures and the assessments and evaluation tools commonly used in the fields rehabilitation, we recommend the following assessments and evaluations. transferring oneself (d ) moving from one surface to another, such as sliding along a bench or moving from a bed to a chair, without changing body position caring for body parts (d ) looking after those parts of the body, such as skin, face, teeth, scalp, nails and genitals, that require more than washing and drying services, systems and policies for preventing and treating health problems, providing medical rehabilitation and promoting a healthy lifestyle ( ) evaluation of dyspnea: modified borg scale for daily follow-up. ( ) subjective fatigue assessment: rating of perceived exertion. ( ) limb pain assessment: visual analog scale and oral rating scales. ( ) evaluation of anxiety and depression: zung's anxiety/depression scales, self-rating depression scale and self-rating anxiety scale for regular follow-up evaluation. ( ) vital signs evaluation: record the body temperature, respiration, pulse, blood pressure, blood oxygen saturation, urine volume, and other indicators regularly every day, and make relevant records before and after the intervention treatment. ( ) imaging evaluation: chest x-ray; if necessary, ct and color doppler echocardiography may be used to evaluate the morphology of heart and lung and provide an objective basis for making a treatment plan. ( ) assessment of bone, joint and muscle: bed rest or disease con- we recommend the whodas . , activities of daily living (adl) assessments, and the -item short form health survey (sf- ) to evaluate patients' activities of daily life and participation. the whodas . is a standardized activity and participation assessment tool recommended by the who. according to the severity of the patient's condition, adls should be evaluated regularly for mild, medium, severe, and discharged patients, including basic adl evaluation and instrumental adl evaluation for cases who return to the community after discharge. the improved barthel index or other instrumental adl scales are recommended. for severe cases, we recommend observational evaluation. as there are no assessment scales specific to covid- , we recommend using the medical outcomes study sf- or the copd assessment test in order to shorten the time of evaluation. considering that covid- cases may have different health conditions and will be at different rehabilitation stages, we recommend not only collecting data of vital signs, laboratory tests, and other information on disease, but also evaluating pulmonary function, subjective fatigue, dyspnea, pain, joint and muscle function, activity level, and quality of life tailored to patients' health conditions. those assessments should be carried out pre-and post-rehabilitation. only comprehensive and systematic rehabilitation data will provide evidence for the effect of rehabilitation in the intervention of infectious diseases, such as covid- . [consensus ] we developed a protocol of rehabilitation intervention based on the icf tailored to covid- diagnosis, functional status, and unmet needs of rehabilitation. within the framework of the who-fics, rehabilitation service de- the main clinical manifestations of covid- are respiratory dysfunction, with pulmonary consolidation and airway secretion obstruction. according to the patient's condition, the therapist can use bodyposition drainage, vibration and clapping, active cycle of breathing techniques, and other techniques or equipment to clear the airway, and should pay attention to the local humidification of the whole body and airway to reduce the viscosity of the sputum. for mild, medium, and heavy patients, and patients after discharge, reducing the time spent in bed is helpful to reduce the risk of various bed complications, promote the improvement of cardiopulmonary function, and shorten recovery time. the threshold loading inspiratory muscle training device is the most commonly used method of respiratory resistance training at present. generally, the initial load is % of the personal maximum inspiratory respiratory control can significantly improve the experience of breathing, reduce respiratory-related oxygen consumption, and relieve the tension of patients. generally, deep and slow breathing is used to increase the compliance of the respiratory system, reduce the work of breathing, and relieve the dyspnea of patients. diaphragmatic breathing or abdominal breathing also have similar effects. if possible, physical therapy can be used for training, such as an electrical stimulation diaphragmatic trainer, electronic biofeedback, and so forth. in aerobic training, it is best to monitor blood pressure, heart rate, and blood oxygen saturation. ( ) intensity: patients in the acute stage mainly take low-intensity exercise without fatigue on the second day. in general, patients in better condition can try medium-intensity exercise. after discharge, patients can carry out medium-and high-intensity exercise training according to further evaluation results to obtain more benefits. ( ) frequency: according to the patient's tolerance, they should carry out active and passive training once or twice a day. if the patient's condition is serious and the tolerance is poor, they should shorten the training duration and increase the frequency accordingly to ensure the training quantity. long-term bed rest can lead to joint stiffness, contracture, and other changes. patients should be guided to actively carry out active and passive motions of the spine and limb joints to maintain their normal range of motion, which can be arranged - times per day and can be completed by joint and position. severe patients may not be able to complete the active whole joint motion effectively. at this time, they may need other people or special equipment to carry out the passive motion of joints, including the limbs, head, neck, and waist, to reduce the risk of deep vein thrombosis. ( ) ultrashort wave therapy: ultrashort wave therapy can promote the exudation and absorption of the lung and improve ventilation function. it can be used for patients with lung exudation and the specific prescription is mainly short-term with micro or without heat; however, fever is a contraindication. small ultrashort waves can be used for bedside treatment to reduce the impact of high-frequency electromagnetic fields on monitoring equipment, but the ultrashort wave machine, its electrodes, and wires should be disinfected and protected according to the protection level. ( ) ultraviolet therapy: whole-body ultraviolet irradiation can increase immunity function, which may be applicable to mild and medium patients, but severe and critical patients may have immune disorders, so it is not recommended. ( ) low-frequency neuromuscular electrical stimulation therapy: neuromuscular electrical stimulation can improve the respiratory muscle and peripheral muscle function, so it can be used in bed patients for respiratory muscles or limb muscles, to delay muscle disuse atrophy, and to increase neuromuscular function. for some covid- cases, there may be some negative stress responses, mainly emotional disorders, such as panic, anxiety, and somatization symptoms, which affect the mood, state, sleep and overall mental health level. , these psychological and behavioral disorders will affect the treatment effect of patients. for hospitalized patients with emotional disorders, such as anxiety or depression, we recommend: the implementation of psychological intervention as early as possible (including cognitive therapy and behavior therapy); the elimination of stressors; the improvement of patients' anxiety or depression; establishing a positive and optimistic mood; and seeking support from families, medical staff, and psychologists. in addition to psychological and behavioral interventions, drug therapy and biofeedback therapy can also be used in the treatment of severe anxiety or depression. for covid- patients who receive rehabilitation in the community, we recommend: the establishment of a psychological support service system; the relief of panic about infectious diseases at the community level; the establishment of a psychological support and assistance system between community members, family members and patients; and the provision of special psychological services for those who suffer critical psychological events in the pandemic situation, such as the death of family members, to ensure that patients will not suffer from serious psychological obstacles that reduce their quality of life. in view of the psychological problems caused by covid- , we recommend to provide mental health services for patients and their families, assist them to acquire and understand the correct information about the pandemic and the impact of covid- , prevent them from panic and long-term stress state, and help them to establish a positive lifestyle and behaviors. participating in taijiquan, wuqinxi, baduanjin, and other physical activities is helpful to regulate breath, dredge meridians, and improve stability of the core muscle group and balance ability. these activities are especially suitable for elderly or weak patients with low physical abilities and can be carried out by mild, medium, and discharged patients, using group mutual aid mode or at home through video exercises. we recommend the following criteria for interruption of interven- to ensure that patients receive high-quality rehabilitation services from medical institutions, rehabilitation institutions, and community based service providers. we should build a patient-centered rehabilitation service system. it is necessary to establish a multidisciplinary rehabilitation team for patients with covid- . according to the functioning characteristics and the rehabilitation stage of patients, individualized rehabilitation intervention strategies and approaches are recommended. , we should establish a comprehensive rehabilitation service system in all professional fields, integrating all levels of health services, and providing comprehensive rehabilitation services for covid- patients from clinical treatment to community rehabilitation services. in the community, we should especially emphasize the empowerment of patients, enhance their self-confidence, and improve their overall functions and their quality of life. for patients in different rehabilitation stages, we should analyze their unmet needs of rehabilitation, main functioning disability and rehabilitation resources from medical institutions, rehabilitation institutions and communities levels, and establish different rehabilitation solutions to improve the quality and cost-effectiveness of rehabilitation. we recommend: the establishment of a rehabilitation service platform; cooperation with experts in epidemiology and clinical medicine; and the integration of rehabilitation into the modern health-service system. for special patient groups, such as the elderly, people with disabilities, and children, we strongly recommend the consideration of their special needs and obstacles, as well as multiple functioning and its impact on covid- rehabilitation. in the community, we recommend the all members pay attrention to the negative influences and discrimination against covid- cases. the proposed measures include the provision of correct information, the prevention of panic and bias, and the consideration of the psychological, social, and environmental factors in community rehabilitation services. thanks to members of the expert group for guidance and review of this paper. nothing to disclose. bin zeng https://orcid.org/ - - - office of the state administration of traditional chinese medicine.novel coronavirus pneumonia treatment and treatment plan clinical course and outcomes of critically ill patients with sars-cov- pneumonia in wuhan, china: a single-centered, retrospective, observational study clinical characteristics of coronavirus disease in china world health organization. world health organization family international classifications, who-fics research on rehabilitation guidelines using world health organization family international classifications: framework and approaches rehabilitation : realization of united nation sustainable development goals world health organization. groups that were involved in icd- revision process international classification of functioning, disability and health (international chinese supplement) construction of knowledge system of modern sciences of rehabilitation and rehabilitation education regarding icf model international classification of functioning, disability and health: a model for the unified conceptual description of physics and rehabilitation medicine building a special subject area for human function and rehabilitation research: developing a comprehensive structure from cell to society the development and application of icf: the construction of rehabilitation knowledge system and clinical tools world health organization. international classification of health interventions (ichi) construction of national framework and data systems of functioning, disability, and health of information using icf icf based disability and rehabilitation information standard and its applications world health organization world health. organization. rehabilitation in health service system world report on disability: implications to disability and rehabilitation world report on disability: framework, approach and implications to disability the world health organization and the world bank jointly released the first world disability report, an important international document on disability development physical and rehabilitation medicine in health-care systems: longterm care and community-based rehabilitation rehabilitation: rehabilitation as a health strategy definitions and concepts of prm the clinical field of competence: prm in practice . physical and rehabilitation medicine-clinical scope: specific health problems and impairments . rehabilitation: rehabilitation as an intervention physical and rehabilitation medicine-clinical scope: physical and rehabilitation medicine interventions rehabilitation : international rehabilitation development and call for action rehabilitation : meet ever-increasing rehabilitation needs developing health care and rehabilitation services for the health of people with disabilities -learning from the who global disability action plan - : improving the health of all people with disabilities who rehabilitation in health system: background, framework and approach, contents and implementation novel coronavirus pneumonia emergency response epidemiology team. the epidemiological characteristics of an out-break of novel coronavirus diseases (covid- ) in china general anatomy report of novel coronavirus pneumonia death corpse characteristics of and important les-sons from the coronavirus disease (covid- ) outbreak in china: summary of a report of cases from the chinese center for disease control and prevention technical guidelines novel coronavirus icf core classification combination clinical practice manual psychological and behavior barriers and psychological rehabilitation strategies for natural disaster survivors operational considerations for case management of covid- in health facility and community novel coronavirus infection related icd code issued by the national health and health commission of china world health organization. who disability assessment schedule . 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university), mingming zhao (guangxi jiangbin hospital key: cord- -ugeupo u authors: sim, shuzhen; ng, lee ching; lindsay, steve w.; wilson, anne l. title: a greener vision for vector control: the example of the singapore dengue control programme date: - - journal: plos negl trop dis doi: . /journal.pntd. sha: doc_id: cord_uid: ugeupo u vector-borne diseases are a major cause of morbidity and mortality worldwide. aedes-borne diseases, in particular, including dengue, chikungunya, yellow fever, and zika, are increasing at an alarming rate due to urbanisation, population movement, weak vector control programmes, and climate change. the world health organization calls for strengthening of vector control programmes in line with the global vector control response (gvcr) strategy, and many vector control programmes are transitioning to this new approach. the singapore dengue control programme, situated within the country’s larger vision of a clean, green, and sustainable environment for the health and well-being of its citizens, provides an excellent example of the gvcr approach in action. since establishing vector control operations in the s, the singapore dengue control programme succeeded in reducing the dengue force of infection -fold by the s and has maintained it at low levels ever since. key to this success is consideration of dengue as an environmental disease, with a strong focus on source reduction and other environmental management methods as the dominant vector control strategy. the programme collaborates closely with other government ministries, as well as town councils, communities, the private sector, and academic and research institutions. community engagement programmes encourage source reduction, and house-to-house inspections accompanied by a strong legislative framework with monetary penalties help to support compliance. strong vector and epidemiological surveillance means that routine control activities can be heightened to specifically target dengue clusters. despite its success, the programme continues to innovate to tackle challenges such as climate change, low herd immunity, and manpower constraints. initiatives include development of novel vector controls such as wolbachia-infected males and spatiotemporal models for dengue risk assessment. lessons learnt from the singapore programme can be applied to other settings, even those less well-resourced than singapore, for more effective vector control. vector-borne diseases (vbds) are a major cause of morbidity and mortality in the tropics and subtropics, accounting for more than % of the global burden of infectious diseases [ ] , with over % of the world's population at risk from at least one vbd [ ] . aedes-borne diseases, including dengue, chikungunya, yellow fever, and zika, are increasing at an alarming rate driven by urbanisation, local and global population movement, and climate change [ ] [ ] [ ] . aedes aegypti mosquitoes lay eggs in a wide variety of artificial containers and structures, including those that occur in discarded plastic containers, water storage containers, flowerpots, tyres, poorly constructed concrete structures in the ground, and gutters, which abound in urban environments. the main tool we have for controlling vbds is vector control [ ] . although vector control has been hugely successful against some vbds such as malaria [ ] , weak implementation of sustainable programmatic vector control has struggled to control aedes-borne diseases in many parts of the world in the past years. margaret chan, former director-general of the world health organization (who), famously said in her world health assembly address that the zika epidemic was "the price being paid for a massive policy failure that dropped the ball on mosquito control in the s" [ ] . in order to strengthen vector control, who member states called on who to develop the global vector control response - (gvcr) [ ] . this strategic document includes a framework of key priorities for vector control strengthening. the gvcr calls for collaboration within and outside the health sector, increased engagement of communities, scaling up and integration of vector control tools and approaches, and improved surveillance and monitoring and evaluation (fig ) . this is supported by a foundation of capacity and capability strengthening and by increased basic and applied research and innovation. also important are factors including country leadership, advocacy, resource mobilisation, and regulatory, policy, and normative support. who member states are reorienting their programmes in line with the gvcr [ ] , but good examples of the gvcr principles in action are currently limited. one exception is the dengue control programme in singapore, which in fact predates the gvcr but adopts many gvcr principles. this manuscript aims to document the key features of the programme, highlight how they sit within the gvcr framework, and draw out important lessons that can be applied by other vector control programmes, including those less well-resourced than singapore's. the republic of singapore is an island city-state in southeast asia with a land area of . km and a population of . million [ , ] . singapore is located at the southern tip of the malay peninsula, connected to peninsular malaysia via two causeways and by ferry services with indonesia's riau islands to the south. singapore is a travel and business hub with . million visitors in [ ] . the city-state is highly urbanised and has a high population density with almost , people per km , and typically tens of thousands of people per km in the main residential areas [ ] . since , singapore has been working towards the vision of creating a 'city in a garden', where greenery and biodiversity are seen as solutions to improving health and well-being of its citizens [ ] [ ] [ ] . seventy-nine percent of singapore's residents live in high-rise apartments built by the government's housing and development board (hdb), with the remainder living in privately owned condominiums ( %) or landed property ( %) [ ] . the climate in singapore is tropical and it is hot and humid all year round. singapore is endemic for dengue, with all four dengue virus (denv) serotypes circulating, frequent emergence of various genotypes, and a cyclical pattern of outbreaks every - years [ ] [ ] [ ] [ ] . in in , in , , and , singapore experienced explosive dengue fever outbreaks that resulted in , , , , , , and , indigenous cases, respectively, with incidence rates of . , . , . , and . per , population [ ] [ ] [ ] [ ] . in , singapore also experienced a large dengue outbreak with more than , cases [ ]. there is low herd immunity, particularly among younger generations, due to decades of low dengue transmission [ ] [ ] [ ] . the primary dengue vector is a. aegypti, and although aedes albopictus is also present, it is considered a weak secondary vector [ ] . exposure to chikungunya is low in singapore, with seroprevalence of . % among adults [ ] . the country has experienced small local outbreaks of chikungunya, with the largest ( , cases and an incidence rate of . per , ) occurring in , a year when aedes densities were high [ ] . singapore's first zika outbreak occurred in , and although it occurred at the same time as the epidemic in brazil and other latin american countries, the zika strain was found to have originated in southeast asia [ ] . malaria was eliminated in singapore in [ ] , but there are still sporadic imported cases and competent vectors including anopheles epiroticus (formally anopheles sundaicus), anopheles maculatus, and the emerging vector anopheles sinensis [ , ] . since independence, singapore has recognised that a clean and green environment is necessary not only to ensure good health and a good quality of life for its people but also for economic competitiveness. the government embarked on projects to clean up the land and waterways and invested heavily in critical sanitation and environmental infrastructure, including drainage development projects, sewerage and used water treatment infrastructure, and solid waste management. the environmental management put in place to implement this high standard of public cleanliness has greatly benefited singapore's efforts to tackle vbds. underscoring the view that aedes-borne diseases are environmental diseases, dengue control in singapore is led by the national environment agency (nea), a statutory board of the ministry of the environment and water resources (mewr). in view of the importance of infrastructure maintenance and design, environmental sanitation, people's behaviours, and use of technologies on dengue prevention, the nea collaborates closely with other government ministries (e.g., health, national development, education, finance), town councils (responsible for management and maintenance of the common property of public housing estates, including vector control), community associations, research and academic institutions, and the private sector (fig ) . intersectoral activities are coordinated by an inter-agency dengue taskforce which meets regularly, and monthly during outbreaks. in the event of a severe dengue outbreak, the taskforce membership is escalated to minister level. in addition to regular meetings, taskforce members are also in close contact via email and telephone to exchange feedback and information-for example, on unusual aquatic habitatsin a timely manner. resources for government agencies to carry out dengue control activities are allocated by the ministry of finance, to which each agency justifies its own funding needs. if necessary, nea supports these justifications, especially in an outbreak year when nea has called on agencies to step up dengue control measures. nea may also offer subsidies to town councils to support enhanced dengue control measures in public housing estates. for example, an important partner of the nea is the hdb, the statutory board responsible for public housing. in high-rise apartments in singapore, laundry is typically hung out to dry on bamboo poles fixed into tube-shaped bamboo pole holders on the side of the building. discovery of substantial numbers of aedes larvae in these holders led to provision of caps to cover them when not in use. later, the clothes-drying system was redesigned such that the bamboo poles now rest on brackets instead, eliminating the need for holders (fig ) . as mounting the bamboo poles in the holders required residents to lean out of the window, replacing the holders with brackets not only removed a mosquito breeding habitat but was also safer for residents. antimosquito valves that allow water to drain away but prevent escape of mosquitoes are installed in gully drains in hdb apartments, and hdb blocks are constructed without roof gutters, since these are difficult to access and maintain at height and therefore can become aedes habitats. nea works closely with town councils who are responsible for vector control around the hdb blocks. construction sites play an important role as a driver of sustained dengue transmission [ ] , since rainwater-filled land excavation holes, construction materials, and equipment (e.g., water tanks, skips, canvas sheeting) can become aedes habitats. the singapore contractors association limited (scal) is therefore an important partner for nea. construction sites are mandated to engage an environmental control officer (large sites may even have their own dedicated officer) who ensures appropriate action is taken to reduce vector proliferation, including larviciding with bacillus thuringiensis israelensis (bti) (fig ) . the land transport authority is responsible for good housekeeping and vector control on their infrastructure construction sites and the urban redevelopment authority conducts vector control along roads and their car parks. within the nea, the department of public cleanliness maintains a system of daily litter collection and its mandate is cleaning to 'public health standards'. approximately % of singapore's waste is recycled and the remainder incinerated, with the waste ash deposited on an offshore landfill site, semakau island, helping expand the island. this serves to reduce artificial containers in the environment which could otherwise become habitats for aedes mosquitoes. within the mewr, the nea works alongside the public utilities board (pub), which is responsible for ensuring a sustainable and efficient water supply and responsible for drainage system in singapore. vector control activities of the pub include designing drains for maintainability (accessible and with sufficient gradient to prevent water pooling) and regular flushing of drains monthly or bimonthly. the department of public cleanliness conducts regular cleaning of drains to remove any debris or refuse. the national parks board (nparks) also works closely with nea to maintain a pleasant environment with trees, plants, and water features such as ponds and streams, while keeping vector densities to a minimum. vector control measures implemented include weekly bti treatment of ponds and regular removal of floating vegetation. if vectors do become a problem, surveillance and vector control measures are quickly put in place. for example, in the first quarter of , ornamental papyrus beds in bishan-ang mo kio park encouraged the proliferation of biting midges and a. sinensis. nea's identification of the vectors responsible led to control measures including bti application, intermittent drying of the papyrus beds, and the nea corporate communications department is responsible for mass and social media communications, whereas the p (people, private, public) network division leads nea's education and publicity initiatives and programmes for the p sectors, across all environmental initiatives, not just dengue prevention. community engagement makes use of existing structures including the people's association (the statutory board responsible for promoting social cohesion) and grassroots organisations under the people's association, such as citizens' consultative committees, residents' committees in hdb estates, and neighbourhood committees in private housing estates. these groups encourage bottom-up participation by seeking residents' cooperation in checking for mosquito breeding in homes. nea also trains members of the public and the people's association's community emergency response teams as dengue prevention volunteers, who educate fellow residents on dengue prevention. each year the p network division organises the national dengue prevention campaign, with the timing of the launch dependent on the dengue forecast provided by the environmental health institute (ehi), the research arm of nea. p work through the mayors of each district, grassroots members, and dengue prevention volunteers who mobilise their communities to conduct source reduction according to the ' -step mozzie wipeout' by doing house-to-house visits, distributing educational materials, and organising block parties and other events. the ' -step mozzie wipeout' targets the top five most common habitats in residential premises in singapore. information materials are available in all four written national languages (fig ) . the ' -step mozzie wipeout' recommends to ( ) turn the pail, ( ) tip the vase, ( ) flip the flowerpot plate, ( ) loosen the hardened soil, and ( ) clear the roof gutter and place bti larvicide inside. for those interested in aedes control outside singapore, it is important to note that these aquatic habitats may not be the top five habitats in other countries, so it is important to survey local sites to identify the major sources of a. aegypti. in singapore, messaging is directed towards people taking personal responsibility for mosquito prevention and explaining that by conducting source reduction, they can protect their families from dengue. p uses different methods to evaluate knowledge, attitudes, and practices of communities over time and looks for fresh angles to prevent fatigue from regular public health messaging. besides nationwide general messaging, community engagement strategies also target specific population groups to encourage them to play a greater role in mosquito prevention, including domestic helpers, construction workers, the elderly, and school children. for example, domestic helpers and construction workers are targeted with behaviour change messaging through outreach and roadshows at dormitories, shopping malls, and other places of congregation. since these groups are often migrants and therefore transient populations, behaviour change materials are produced in the relevant languages (e.g., bahasa, hindi, indonesian, tagalog) and outreach is conducted regularly. dengue prevention roadshows are also conducted at elderly care corners and videos are available in local chinese dialects used by many elderly residents who originate from mainland china. the p network division partners with the ministry of education to include dengue prevention in school curricula at primary, secondary, and tertiary levels. timely information on the number and location of dengue cases is made publicly available on the nea website and myenv mobile app. nea also implements a community dengue alert system, in the form of colour-coded banners placed in high-visibility locations in dengue clusters to inform residents about the dengue situation in their neighbourhood and the corresponding actions they can take (fig ) . the banners use the widely recognisable 'traffic light' colour code of red (high alert), yellow (medium alert), and green (low alert) to allow for easy interpretation of the situation. communities are engaged and regularly give feedback about, for example, increased mosquito numbers, littering, and other environmental issues either online or via a -hour nea hotline. globally, aedes indices such as the house index (hi, percentage of houses positive for larvae and or pupae) are traditionally used for aedes vector monitoring, with a value of % often being used as an arbitrary dengue transmission threshold [ , ] . the singapore dengue control programme has brought the hi to very low levels (from % in the s to . % in the s). despite this low hi, singapore still experiences regular outbreaks, suggesting that the hi is no longer sensitive for dengue risk assessment [ , ] . with low vector populations, the singapore programme now uses in-house-developed gravitraps, which are designed to lure and trap gravid female aedes on the sticky lining [ ] . since , a system of , gravitraps have been deployed in public housing estates nationwide, and the scheme will be expanded to landed housing by end of [ ] . monitoring of the traps every weeks is currently outsourced, although an automated trap is currently under development by nea. gravitrap indices are plotted on a geographical information system (gis) and used to target intensified source-reduction campaigns. areas with a high gravitrap index are also published on the nea website to motivate the local community to take action to reduce dengue transmission. in keeping with the country's green aspirations, insecticides are used judiciously, with bti and temephos used as larvicides and pirimiphos-methyl as adulticide. choice of insecticide is guided by resistance monitoring, which is performed every few years. as well as aedes, surveillance is also conducted for culicines (potential japanese encephalitis vectors) and anophelines using the in-house-developed night catcher, a modified cdc light trap that keeps caught adult mosquitoes fresh and alive for analysis and segregates hourly-caught mosquitoes in separate containers. the ministry of health is responsible for case surveillance and clinical management of dengue patients. dengue is a notifiable disease, meaning that medical practitioners and clinical laboratories must report clinically suspected and laboratory-confirmed cases. if a patient presents at a health facility with suspected dengue, then blood samples are taken for diagnostic testing at a hospital or private laboratories using either rapid diagnostic tests against nonstructural protein (ns ) and immunoglobulin m (igm) antibodies or reverse transcriptase polymerase chain reaction (rt-pcr) for acute cases. alternatively, samples can be sent to the ehi for diagnosis, and through this system, ehi is able to monitor circulating dengue serotypes [ ] . an epidemiological investigation of each case, conducted by telephone or in person, is triggered by the environmental public health operations department at nea, and case locations are plotted on a gis interface. a dengue cluster is formed when two or more cases have onset within days and are located within m of each other (based on residential and workplace addresses, as well as movement history collecting during the epidemiological investigation). dengue clusters are graded and the situation communicated to the public via the colour-coded community dengue alert system: high-risk area or more cases (red); high-risk area with fewer than cases (yellow); and no new cases, under surveillance for the next days (green) (fig ) . once a cluster is formed, this triggers the nea environmental public health operations team to ramp up vector control activities in the cluster. entomological indices and dengue case numbers are not reliable measures for assessing the long-term impact of vector control programmes because of changes in surveillance and diagnostic capabilities over time [ ] . instead, nea uses blood bank igg seroprevalence to estimate the force of infection (foi) over time [ ] . the singapore dengue programme relies predominantly on source reduction and larviciding using bti, which are implemented throughout the year through community and programme efforts. in the first months of , approximately % of vector habitats were found in residential premises, rising to % in cluster areas. house inspections are conducted routinely and at increased frequency in cluster areas by the environmental public health operations team (fig ) . field staff follow a strict protocol including identifying themselves clearly and ensuring that the resident witnesses the taking of any samples for species identification at the ehi. use of insecticides is seen as a short-term solution, so fogging with organophosphates is restricted to clusters during outbreaks only. source-reduction activities are facilitated by legislation and law enforcement, which singapore uses in addition to community engagement to enhance public compliance. according to the control of vectors and pesticides act (cvpa, the main legislation dealing with mosquito breeding), the operations team can enter homes to conduct inspections and vector control, and residents are fined at least s$ (us$ ) if aquatic stages of vectors are found on their premises [ ] . inspections of construction sites and other premises are also conducted by a dedicated nea team. if aquatic stages of the vector are found, then an order can be served for vector control to be implemented within a specific time period by a registered vector control personnel. in the event that environmental management is found wanting, the cvpa allows nea to issue an order to stop any work being undertaken on the premises indefinitely or until vector control to remove favourable habitats has been carried out. a list of construction sites that currently have stop work orders are available on the nea website (www.nea.gov.sg). failure to comply with the order can lead to a fine of up to s$ , (us$ , ) and, in the case of a second or subsequent conviction, to a fine of up to s$ , (us$ , ) and/or imprisonment for up to months. the cvpa also covers pesticides registration, as well as licensing and certification of private-sector vector control operators [ ] . to address challenges such as climate change, increasing urbanisation, and the manpowerintensive nature of source-reduction activities, the singapore programme invests in research and development of new vector control technologies. for example, ehi is evaluating the use of wolbachia, a maternally inherited endosymbiotic intracellular bacterium, which when artificially introduced into a. aegypti can suppress dengue infections. singapore opted for a population-suppression strategy whereby only male wolbachia mosquitoes are released. when male wolbachia mosquitoes mate with wild-type females, the eggs produced will not hatch, because of a phenomenon called cytoplasmic incompatibility. use of suppression was favoured over a population-replacement strategy, in which both males and females are released, since it is in line with the long-term programme strategy of source reduction. wolbachia testing has followed a phased approach in two main release sites, including gaining an understanding of the basic biology of the released male wolbachia mosquitoes in the field, such as how far and how high they fly. the programme has also collaborated with the international atomic energy agency (iaea) to irradiate wolbachia mosquitoes at the pupal stage to render infertile any remaining females, so as to avoid replacement of the wild-type population with wolbachia a. aegypti mosquitoes. pilot testing has been accompanied by a careful community engagement campaign developed by ehi to emphasise that wolbachia is safe and that male mosquitoes do not bite, and to encourage continued source reduction. the programme also works with private-sector collaborators to develop and evaluate technologies for wolbachia testing and implementation. ehi works with orinno technology, a local start-up company, to develop new automated equipment to facilitate their work, including a larvae counting system, pupae sorting and counting system, and mosquito launcher to simplify and speed up the releases of the wolbachia mosquitoes by field staff. the programme also works with verily life sciences, an alphabet, inc., affiliate, to field-test the company's automated sorting and release technologies. the dengue control programme has developed a novel indicator for entomological risk assessment known as the a. aegypti breeding percentage [ ] . routine larval surveillance is not uniform spatially and temporally and so would be biased if used for risk assessment. instead, the breeding percentage expresses the number of a. aegypti-positive habitats over the total number of aedes-positive habitats (a. aegypti and a. albopictus) to cancel out the sampling error from nonsystematic inspection and cryptic breeding sites. predicting dengue outbreaks is difficult and the ehi has, in partnership with academic and research institutions including the national university of singapore, developed several different risk models to enable better resource planning and preparedness for outbreaks. for example, a risk map is prepared each year to guide resource allocation to different areas [ ] , a temporal model is used to predict dengue cases up to months in advance [ ] , and a spatiotemporal model integrating climate, vector density, population demographics (connectivity using public transport and mobile phone data), cases, infrastructure (age of building and number of units), and satellite data (vegetation) is used for high-resolution prediction and realtime allocation of resources [ ] . staff personal and professional development is a focus of the nea. for example, staff undertake continuing professional development courses organised by the internal training arm of nea, the singapore environment institute. rotations between departments are encouraged and staff can receive financial support and leave of absence to attend further education. there are possibilities for both vertical and horizontal movement within the organisation, recognising the need for both specialists and generalists. the ehi partners with academic and research institutions, and staff members have obtained phd and other degrees through their research work conducted at the ehi. the ehi of nea has been a who collaborating centre for reference and research of arbovirus and their associated vectors since . this involves consulting and advising (e.g., the director of ehi sits on the who strategic technical advisory group on neglected tropical diseases and strategic advisory group of experts working group for dengvaxia, the sanofi dengue vaccine), enhancing global outbreak preparedness (e.g., cross-border virus surveillance through unitedengue consortium, evaluation of diagnostics, etc.) and capacity building (e.g., training and sharing of best practice). the singapore dengue control programme is one of the best in the world, but what makes it so successful, and how can the lessons learnt be applied to other vector control programmes? although in many countries dengue control sits under the ministry of health, unusually in singapore it sits within the mewr. this is in line with the programme view that dengue is an environmental disease. dengue vector control uses mainly environmental management approaches, such as proactive source reduction, and environmental management including drainage and house improvements contributed to the elimination of malaria from singapore in [ ] . key individuals including the director-general of public health, could be trained as engineers or other professionals, not medical doctors. a strong sense of environmentalism stems from singapore's founding father, lee kuan yew, who oversaw the transformation of singapore after independence and in championed the idea of the 'garden city' [ ] . lee kuan yew promoted a green environment that was free of litter in order to create good living conditions for singapore's residents, but also to simultaneously encourage tourism, investment, and trade. strong political will and long-term political stability (the people's action party have been the only party to form a government since independence in ) means that this vision and trajectory has been maintained over time, for example, in the current sustainable singapore blueprint [ ] . despite sitting within mewr, the programme collaborates closely with the ministry of health with efficient systems for sharing information on confirmed cases to allow rapid intervention by the nea environmental public health operations team. adopting a similar environmental approach to vector control could enable more effective control of vbds worldwide (and incidentally was largely responsible for the success of vector control in the early and mid- s before the advent of ddt [ ] ). for example, progress in controlling malaria is stalling in many high-burden countries due to weak vector control programmes, and potentially also insecticide resistance [ , ] . since malaria is primarily a disease caused by standing water, proactively tackling immature vectors by using environmental management could be a synergistic addition to predominantly insecticide-based adult anopheline control. increasingly complicated and multidimensional public issues including climate change, globalisation, public health, and infectious disease outbreaks call for a transformation in public administration. since the s, singapore has adopted a whole-of-government approach, which 'denotes public service agencies working across portfolio boundaries to achieve a shared goal and an integrated response to particular issues' [ ] [ ] [ ] . the whole-of-government culture, propagated for decades in singapore, facilitates the view of dengue control as a shared responsibility across agencies. for example, cross-sectoral collaboration for dengue control is facilitated by the inter-agency dengue taskforce. further, rotation of leadership between different government departments and agencies means that so-called 't-shaped' managers have not only specialist expertise but a broader perspective on issues and can help to break down departmental or agency silos [ ] . this coordinated whole-of-government approach is exemplified by the singapore response to a dengue outbreak that coincided with the start of the covid- pandemic in early (box ). singapore also employs collaborative governance, whereby governing is based on collaboration between government and nongovernment stakeholders. this is exemplified by the important role of the people's association in bridging between government and communities. community outreach initiatives enjoy broad political support, as they provide an opportunity for the government to directly connect with the community. local politicians are also invested in preventing outbreaks in their constituencies and often communicate the importance of dengue prevention to residents during walkabouts. another success factor may be the use of a 'carrot and stick' approach to source reduction with community engagement and behaviour change campaigns led by the p network division, backed up by strong legislation and enforcement. a recent study conducted by ehi shows that houses that have more frequent inspections have a lower number of reported mosquito larval habitats [ ] , lending support to the system of house inspections. a lack of corruption (singapore is rated as one of the least corrupt nations in the world by transparency international [ ] ) also supports the penalty system for vector habitats. the clear accountability of mosquito breeding offences under the law makes it easier for stakeholders to understand their respective roles, thus facilitating collaborative action against mosquito breeding. strict enforcement of the law is another push factor that encourages joint efforts to take preventive measures. imposition of fines for vector habitats may not be possible in all vector control programmes globally but should be considered. singapore's dengue control response in , which is taking place amid the covid- pandemic, offers a case study of intra-and intersectoral collaboration to combat twin environmental public health threats. detection of dengue threat and raising the alert more than , dengue cases were reported in the first quarter of , double that for the same time period in [ ] . in early , ehi's risk models, incorporating case data from the ministry of health, forecasted a dengue surge in the coming months. ehi's analysis of serotype trends further detected an increase in the proportion of denv- cases, with denv- overtaking denv- as the predominant serotype in early . as denv- has not been predominant in singapore for nearly three decades, population immunity to this serotype is likely low, further increasing the risk of an outbreak. given this outlook for , nea alerted relevant government agencies and set in motion an enhanced and coordinated dengue control response. with support from political and grassroots leaders, nea brought forward the national dengue prevention campaign (typically held just before the traditional midyear peak dengue season) to late march [ ] , with the intention of raising awareness and rallying the public to conduct preemptive measures early on. this kicked off island-wide community-led outreach efforts, helmed by grassroots leaders and supported by dengue prevention volunteers, to encourage residents to carry out dengue prevention practices. at the organisational level, the nea-led inter-agency dengue taskforce met in january and march to coordinate the response across sectors and continues to meet regularly. emphasis has been placed on enhancing vector control in assets managed by various agencies (such as buildings, reservoirs, drains, and parks), especially if these are located in areas with high mosquito populations or within dengue clusters. singapore reported its first case of covid- on january [ ] . to curb local covid- spread, nea in february launched "sg clean" [ ] , a whole-of-government campaign to rally individuals and businesses to keep public areas clean (such areas include toilets, hawker centres, community spaces, and other premises). dengue control messaging was woven into 'sg clean'. a key campaign message was that enhanced public cleanliness, such as maintaining clean premises and not littering, eliminates mosquito breeding habitats and hence helps to reduce the spread of dengue in addition to covid- . in april , singapore implemented a 'circuit breaker' to curb covid- transmission, which involved stringent social distancing measures and cessation of nonessential work activities [ ] . given the high-risk dengue outlook for , nea worked at the whole-of-government level to include vector control activities as an essential service to what continues to drive transmission in singapore, where there is a well-resourced and effective dengue control programme? the dengue incidence rate in singapore has increased dramatically in the last years, but this is likely because of improved diagnostics, increased referral for testing by medical practitioners, and increased awareness among the public [ ] . a better indicator of the true infection rate is dengue foi: between the s (when singapore first implemented environmental management and vector control programmes) and the s, the dengue foi in singapore dropped -fold to approximately . ( per , individuals per year) and has since held steady at this low level [ ] . the decline in foi can probably be attributed to the effectiveness of the dengue control programme (along with an increasingly ageing population). this success in reducing disease transmission has resulted in a lowered herd immunity against dengue, leaving singapore's population vulnerable to outbreaks despite a low vector population. another challenge is the high level of population movement in and out of the country, which is known to facilitate the co-circulation of denv serotypes [ ] . singapore has , km of expressways and . km of mass rapid transit (mrt) lines across the island; over , people commute into the island state from malaysia each day [ ] ; and in , there were . million passenger movements in and out of changi airport from cities in countries and territories worldwide [ , ] . in order to reduce the foi further, the programme is evaluating innovative strategies such as wolbachia, novel community engagement mechanisms, and risk mapping for more effective intervention targeting. as well as better implementation of current tools and approaches, new vector control tools are urgently needed to combat vbds worldwide. in conclusion, the dengue control programme in singapore provides an excellent example of the gvcr in action. important elements include strong collaboration across government departments and between government and nongovernment actors, integration of tools and approaches, effective surveillance, and community engagement. as a high-income country, singapore is in an enviable position of having reliable government funding for dengue control. nevertheless, aspects such as working across sectors or implementation of environmental management do not need to be expensive, and the former can even save costs for the vector control programme. adoption of these elements could lead to more effective vector control programmes worldwide to reduce the intolerable burden of vbds. be continued during the 'circuit breaker' period. businesses and owners of premises are expected to ensure that adequate vector control activities continue at their premises (including offices, commercial buildings, schools, and construction sites), even if regular operations are on hold. nea continues to carry out island-wide routine inspections and enforcement, with precautions taken to minimise covid- transmission. these precautions include ensuring that officers carrying out inspections are healthy, wear masks, and practise good personal and hand hygiene. despite the efforts of the nea, dengue control has been particularly challenging in because of the switch to denv- , warm weather, and high numbers of people staying at home during the 'circuit breaker' period, which can increase aedes aquatic habitats and provides easy access to blood meals for female aedes mosquitoes. we thank the following individuals for their insights: dulcie chan, rama chandramogan, khoo seow poh, christina liew, sueanne mocktar, ong chin soon, tai ji choong, tony teo, and grace yap of singapore's national environment agency and nanthini elamgovan of singapore's national parks board. thanks also to manuela bernardi for her assistance in producing the figures. • vbds are environmental diseases-situation of programmes within the ministry of environment and/or strengthening environmental management is encouraged. • whole-of-government approaches (working across government ministries) and collaborative governance (collaboration between government and nongovernment) support vbd control. • strong vector and epidemiological surveillance enables targeting of vector control interventions. • consider the role of legislation and enforcement in reducing vector habitats. • stable financing supports effective vector control. • innovation and science-based approaches should be harnessed to support surveillance and control. top five papers world health organization. vector-borne diseases fact sheet integrating vector control across diseases the global burden of dengue: an analysis from the global burden of disease study urbanization and globalization: the unholy trinity of the st century the current and future global distribution and population at risk of dengue the importance of vector control for the control and elimination of vector-borne diseases the effect of malaria control on plasmodium falciparum in africa between address to the sixty-ninth world health assembly by director-general of the world health organization world health organization. global vector control response world health organization. framework for a national vector control needs assessment geneva: who online database-total land area of singapore world bank. population density (people per sq. km of land area) ministry of national development-centre for liveable cities singapore. sustainable singapore blueprint forging a greener tomorrow: singapore's environmental journey from slum to eco-city singapore's journey towards environmental and water sustainability singapore: department of statistics singapore forecast of dengue incidence using temperature and rainfall epidemiological aspects of an outbreak of dengue fever/dengue haemorrhagic fever in singapore the dengue haemorrhagic fever outbreak in singapore and its control dengue in singapore from to : cyclical epidemic patterns dominated by serotypes and communicable diseases surveillance in singapore communicable diseases surveillance in singapore communicable diseases surveillance in singapore communicable diseases surveillance in singapore environment agency. quarterly dengue surveillance data-q , q , q and q dengue seroprevalence of healthy adults in singapore: serosurvey among blood donors seroepidemiology of dengue in the adult population of singapore force-of-infection and true infection rate of dengue in singapore-its implication on dengue control and management gravitraps for management of dengue clusters in singapore seroprevalence of antibodies against chikungunya virus in singapore resident adult population hard lessons in surveillance and response from the singapore zika experience eradication of malaria from singapore risk of anopheles sinensis as an emerging malaria vector in singapore a study on anopheles maculatus and anopheles sundaicus in singapore construction sites as an important driver of dengue transmission: implications for disease control critical examination of aedes aegypti indices: correlations with abundance assessing the relationship between vector indices and dengue transmission: a systematic review of the evidence dengue prevention and years of vector control in singapore who regional office for the western pacific. guidelines for dengue surveillance and mosquito control. manila: who regional office for the western pacific dengue in singapore from to : cyclical epidemic patterns dominated by serotypes and control of vectors and pesticides act a novel entomological index, aedes aegypti breeding percentage, reveals the geographical spread of the dengue vector in singapore and serves as a spatial risk indicator for dengue. parasit vectors mapping dengue risk in singapore using random forest three-month realtime dengue forecast models: an early warning system for outbreak alerts and policy decision support in singapore memoirs of lee kuan yew. singapore: times media private limited connecting government: whole of government responses to australia's priority challenges. canberra: management advisory committee (australian government) a primer on implementing whole of government approaches. dublin: centre for effective services reviewing whole-of-government collaboration in the singapore public service introducing t-shaped managers. knowledge management's next generation nea brings forward national dengue prevention campaign and rolls out additional new tools to combat dengue, with increasing evidence of a sustained switch in dengue virus serotype confirmed imported case of novel coronavirus infection in singapore: multi-ministry taskforce ramps up precautionary measures campaign launched to rally public and businesses to work together to keep singapore clean circuit breaker to minimise further spread of covid- the effectiveness of inspections on reported mosquito larval habitats in households: a case-control study transparency international secretariat increasing airline travel may facilitate cocirculation of multiple dengue virus serotypes in asia dengue outbreaks in singapore and malaysia caused by different viral strains key: cord- -rj i cxy authors: wurapa, frederick; afari, ebenezer; ohuabunwo, chima; sackey, samuel; clerk, christine; kwadje, simon; yebuah, nathaniel; amankwa, joseph; amofah, george; appiah-denkyira, ebenezer title: one health concept for strengthening public health surveillance and response through field epidemiology and laboratory training in ghana date: - - journal: pan afr med j doi: nan sha: doc_id: cord_uid: rj i cxy the lack of highly trained field epidemiologists in the public health system in ghana has been known since the s when the planning unit was established in the ghana ministry of health. when the public health school was started in , the decision was taken to develop a academic-year general mph course. the persisting need for well-trained epidemiologists to support the public health surveillance, outbreak investigation and response system made the development of the field epidemiology and laboratory training programme (feltp) a national priority. the school of public health and the ministry of health therefore requested the technical and financial assistance of the united states centers for disease control and prevention (cdc) in organizing the programme. the collaboration started by organizing short courses in disease outbreak investigations and response for serving ghana health service staff. the success of the short courses led to development of the feltp. by october , the new feltp curriculum for the award of a masters of philosophy in applied epidemiology and disease control was approved by the academic board of the university of ghana and the programme started that academic year. since then five cohorts of residents have been enrolled in the two tracks of the programme. they consist of physicians, veterinarians and laboratory scientists. the first two cohorts of residents have graduated. the third cohort of seven has submitted dissertations and is awaiting the results. the fourth cohort has started the second year of field placement while the fifth cohort has just started the first semester. the field activities of the graduates have included disease outbreak investigations and response, evaluation of disease surveillance systems at the national level and analysis of datasets on diseases at the regional level. the residents have made a total of oral presentations and poster presentations at various regional and global scientific conferences. the ghana feltp (gfeltp) has promoted the introduction of the one health concept into feltp. it hosted the first usaid–supported workshop in west africa to further integrate and strengthen collaboration of the animal and human health sectors in the fetp model. gfeltp has also taken the lead in hosting the first afenet center for training in public health leadership and management, through which the short course on management for improving public health interventions was developed for afenet member countries. the gfeltp pre-tested the integrated avian influenza outbreak and pandemic influenza course in preparation for introducing the materials into the curriculum of other feltp in the network. the leadership positions to which the graduates of the program have been appointed in the human and animal public health services, improvement in disease surveillance, outbreak investigation and response along with the testimony of the health authorities about their appreciation of the outputs of the graduates at various fora, is a strong indication that the gfeltp is meeting its objectives. at the request of the ghana ministry of health, the university of ghana established the school of public health (sph) in october . this is a year course in general public health which awards a master of public health (mph) degree. the sph was one of the beneficiaries of the rockefeller foundation support to the network of public health schools without walls (phswow) in the africa region [ ] . graduates of the sph were found to meet the expectations of the ministry of health, as they took up leadership roles at district level. it was however, realized that a cadre of highly-trained epidemiologists with competencies and skills in applied epidemiology and disease control was needed to manage the existing complex of public health emergencies and emerging and re-emerging diseases, such as severe acute respiratory syndrome(sars) and avian influenza. during the early stages of implementation of the global programme for the control of malaria, hiv/aids and tuberculosis, the lack of highly trained field epidemiologists became more apparent as the demand for expert management, interpretation and use of disease surveillance data increased. unfortunately, the mph programme did not make provisions for the training of this cadre of professionals. a process was initiated to establish a field epidemiology and laboratory training program (feltp) to address the identified need. the ghana feltp (gfeltp) evolved from an initial collaboration with the united states (u.s.) centers for disease control and prevention (cdc), through cooperative agreements with the sph. activities supported by this cooperation included organization of short courses on disease surveillance, outbreak investigations and response. more than serving district health staff (frontline health workers) and mph graduates benefited from these short courses over a three-year ( ) ( ) ( ) period [ ] . parts of the short course materials were later incorporated into the mph curriculum of the school of public health. when, in , the decision was taken to start an feltp, the task of designing the curriculum was spearheaded by the faculty under the guidance of staff of cdc including staff from the sustainable management systems development program (smdp) [ ] . the feltp curriculum was adapted from cdc's core fetp curriculum [ ] . gfeltp graduates receive a master of philosophy (mphil) in applied epidemiology and disease control upon completing all university requirements. in addition, graduates receive certificate of competency in field epidemiology. the program was approved by the university academic board and the national accreditation board in . the program started with an initial cohort of three physicians, one laboratory scientist and one veterinarian. in keeping with the "one health" concept, to mitigate the increasing threat of outbreaks of zoonotic diseases and to further strengthen the laboratory's key role in public health surveillance and response in the country, the trainees/residents were selected from serving staff nominated by the ghana health service, ministry of health (physicians and laboratory scientists) and the veterinary service directorate, ministry of food and agriculture (veterinarians). the vision of gfeltp is to improve the health of the people in ghana. the mission is to contribute to addressing ghana's public health needs and priorities through training and service provision in applied epidemiology and public health laboratory management. the objectives of gfeltp are to: ) strengthen public health capacity by developing a cadre of health professionals with applied skills in applied epidemiology and laboratory management; ) contribute to research activities on priority public health problems; ) improve national capacity to respond to public health emergencies such as disease outbreaks, natural disasters and unusual public health events including those that could be a result of chemical or bioterrorism; ) strengthen national surveillance systems through a team approach (physicians, laboratory scientists and veterinarians); ) improve communications and networking of public health practitioners in the country and throughout the africa region. the gffeltp is a calendar-year programme with about % course work and % field work covering two tracks (i.e., the epidemiology track and the laboratory track). during the first academic year, residents study core courses that cut across the two tracks in the first semester. in the second semester, residents take courses in each of the prescribed track (i.e., epidemiology for medical and veterinary professionals or laboratory for laboratory scientists) and some selected electives to make up for the required credits for the course work. in addition, residents are required to be involved in weeks of field activities made up of weeks at the end of the first semester to undertake evaluation of surveillance systems of selected diseases and weeks at the end of the second semester for analysis of available large datasets on diseases at national or regional levels. in the second year, residents develop their research topics under the guidance of their academic supervisors and mentors. a further requirement is the organization of at least one seminar prior to going for the field work. ten months of the second year are devoted to field practice and collection of data while providing services to the district/region of assignment. the last two months are used for data analysis and write up of theses. during the -year period of training especially when on field postings, residents of the programme join the staff of the ghana health service and veterinary service directorate to investigate and respond to disease outbreaks and public health emergencies. being mid-career professionals in public service, the residents sometimes lead these investigations, conduct public health interventions and present written and verbal reports to stakeholders with support of their supervisors and mentors. five cohorts have so far been admitted into the residency programme. the breakdown is as shown in table . the distribution of residents by professional background and sex is shown in figure and as part of the collaboration between the disease surveillance department(dsd) and the school of public health (sph), a needs assessment to determine the gaps in disease surveillance with emphasis on disease outbreak investigations and response, data analysis and interpretation and capacity development was conducted in fivedistricts in ghana, namely asuogyaman, ketu, kassena-nankana, wassa west and berekum districts. needs assessment tools were developed and discussed by dsd and sph at an orientation before the exercise commenced. the reports from these assessments were compiled into a composite document for implementation of sensitization workshops for the districts. the workshop had participants, made up of disease control officers, nurses, statistician, midwives, and medical superintendent at the volta river authority (vra) hospital, medical assistant and district director of health services. the general objective of the workshop was to give health workers in the district the appropriate knowledge and skills in identifying cases of priority diseases and also process the data and use it for public health action. in addition, core stakeholders such as district assembly members, immigration and custom officers, teachers, information officers, the police and the media were also involved. the specific objectives were to enable participants to: detect priority diseases, analyze and interpret data on priority diseases, investigate and respond to suspected outbreaks, be prepared for disease epidemics, investigate and respond to other priority diseases, supervise and provide feedback and be able to monitor and evaluate idsr implementation. the workshop employed methods including presentations on integrated disease surveillance and response training modules, role-playing, group work and field exercises. similar workshops were organized in ketu, upper east and berekum districts. as a result of these workshops, participating districts reported improvements in their disease detection, investigation and public health response. major activities undertaken by gfeltp residents over the years are summarized as follows: disease outbreak investigations: a total of disease outbreak investigations were conducted by gfeltp residents between and . these include outbreaks on meningitis, influenza (type a), human rabies, food borne diseases, measles, gastrointestinal diseases, yellow fever, pertussis, cholera and herpes b. the investigation of an outbreak of herpes b virus infection in may in techiman and adjoining districts of central ghana reported this virus as the probable cause of zoonotic encephalitis in ghana for the first time.the large number of disease outbreak investigations and the timely response that residents of the programme have been able to carry out alongside other ghana health service or veterinary service staff to date have appreciably enhanced disease surveillance and response capacity in the country. in particular, the role that gfeltp team of physicians, veterinarians and laboratory scientists played in the investigation and response to the ai outbreak in ghana in , the multiple outbreaks of rabies in - , and the monkey-associated herpes-b encephalitis outbreak in demonstrated the great value of the one health concept and the multi-disciplinary team approach which the gfeltp has adopted. disease surveillance and field studies: as part of end-of-year one field requirements, evaluations of various disease surveillance systems were conducted between and . they included both communicable and non-communicable diseases. residents have also analyzed available large datasets for selected diseases at the regional health directorates. cape town, south africa (december, ): at the th tephinet global scientific conference, nine gfeltp residents presented three orals and six poster presentations. one of them, ms. joyce der, a cohort-ii laboratory track resident was the overall winner in the oral presentation category. she presented the epidemiological and laboratory investigation of a food poisoning outbreak at a popular urban-area food center in the eastern region of ghana. accra-ghana, december, : gfeltp hosted the st afenet regional scientific conference following the birth of afenet in august of the same year in accra ghana [ ] . the residents made five oral presentations and six poster presentations. kampala, uganda-december : nine presentations were made by gfeltp residents at the nd afenet regional scientific conference in kampala. four were orals and five were poster presentations. mombasa, kenya-august : a total of posters and oral presentations were made at the th tephinet african regional/ rd afenet scientific conference by gfeltp residents. one of them, dr paul polkuu, a veterinarian and cohort ii epidemiology track resident received the runner-up award for the best poster presentation. the presentation was on the investigation of an influenza-like illness (ili) outbreak at a coeducational high school in the eastern regional mountains of ghana. a paper by a cohort-ii epidemiology track resident "community-wide outbreak of cholera following unhygienic practices by small-scale unregistered gold miners, east-akim district, ghana - " was accepted for publication by the ghana medical journal in september, four public health articles by residents have been published in two veterinary bulletins and two national daily newspaper columns in addition to sph faculty members, selected regional directors of health services and district directors of health services were oriented from the start of gfeltp to serve as supervisors and mentors for residents at various field sites. in may , a resident advisor was appointed for gfeltp. since then, in collaboration with the ghana health service public health division, he has conducted periodic rounds of visits to residents' field sites. the aims of the visits are to ).provide mentorship, supervision and tutoring to residents during their field trainings, ) conduct local stakeholders' feedback and public health consensus seminars and ) conduct program advocacy and sensitization meetings with key stakeholders at regional and district levels. multiple visits have been made to the eastern, central, brong-ahafo, greater accra northern, upper west, upper east, volta and western regions. there have been regional stakeholders' seminars where residents made presentations on projects they undertook in various regions or districts to stakeholders from the community, ghana health service and veterinary services directorate. these fora provided opportunities for feedback, inter-sectoral discussions leading to consensus on public health action and sharing of information on gfeltp activities and opportunities. this novel approach of collaborative training and service at the local level has enhanced public health decision, action and gfeltp visibility at the health system frontline level. the gfeltp has hosted three workshops on improving management of public health interventions. this followed an introductory course to train proposed trainers in . the trainers were deputy directors in charge of public health at regional level in ghana. there were participants and the training was facilitated by cdc, ghana health service (ghs) and gfeltp staff. the first workshop was held from june -july , and was targeted at health practitioners in the african sub-region. twenty-two health officials from four african countries attended the course. out of the participants, were ghanaians, kenyan, tanzanian and ugandan. all ghanaian participants were staff from the ghana health service. the course was divided into four modules. these four modules were designed to touch on all aspects of health management. uniqueness of the course was that during the four-week period, participants presented project proposals on management of public health interventions at the beginning of the course. they were helped to develop the proposals and implement them over the subsequent three months after the course. all participants were visited by a facilitator once during the three months of implementation. the ghanaian participants came back for a day to present the results of what they implemented before receiving their certificates. the regional participants were visited by the coordinator and the afenet focal person for the course in their various countries. participants made their presentations at a meeting of stakeholders before they were awarded their certificates. the workshop with the field component was evaluated six months after the first four-week imphi course ended. the goal of the evaluation was to determine whether the four-week training led to application of skills on the job as outlined in the curriculum and program objectives. it was a joint evaluation by cdc-smdp and stakeholders at the school of public health in ghana. six months after the -week imphi course ended all participants who were interviewed for this evaluation reported implementing a change in management practice at their places of work. only one participant interviewed could not provide any hard evidence for any of the changes she implemented. in collaboration with the usaid/stop ai programme, the gfeltp, in may , pre-tested a newly developed set of modules on integrated avian influenza outbreak response and pandemic influenza in a special two-week training workshop. the purpose of the workshop was to determine the usefulness of these modules in the african setting, with a view of introducing these modules in other feltps. the gfeltp has since then adapted materials from the modules into the gfeltp curriculum, and it has been organized yearly with facilitators from the veterinary services, school of veterinary medicine, national disaster management organization (nadmo) and sph. gfeltp collaboration with the veterinary services directorate, ministry of food and agriculture in ghana has led to the strengthening of the regional epidemiology capacity of the service. two gfeltp graduates currently serve as the regional veterinary epidemiologists in the brong-ahafo and upper west regions. two others are awaiting appointment letters to serve as regional epidemiologists in the central and volta regions. similarly, the ghana health service is finalizing formal plans to deploy the gfeltp graduates to fill such positions in the regions. currently, two of the graduates serve as deputy national program managers for malaria and non-communicable diseases respectively, one as deputy head of the national public health and reference laboratory, three as district directors of health service and de facto regional epidemiologists ( table ) . a steering committee made up of representatives from stakeholders (moh, ghs, veterinary services, laboratory services, nadmo, cdc, noguchi medical research institute and sph) steers the management of the gfeltp to achieve the objectives of the programme. the committee is chaired by moh/ghs and it meets every quarter. the meetings are well documented and shared with all members/partners. the committee follows up plans and recommendations through designated members with support of gfeltp secretariat. a matrix tool for feltp assessment was used to do an internal evaluation of the programme and the result presented to the gfeltp steering committee. the ghana feltp has also gone through assessment by afenet and awarded quality assurance certificate for placement of graduates table shows the placement of graduates, pre and post certification. the genesis and evolution of gfeltp is an example of a national identification of a workforce capacity need and the use of multi-sectoral collaboration with international technical and financial assistance to institutionalize indigenous capacity development in applied epidemiology. the sph at the university of ghana is a well-established constituent member of the college of health sciences of the university. the mph program which is the flagship program of the school is thriving well with enrolment from ghana, the african region and beyond. the gfeltp was developed as a special program based in the epidemiology department of the school. the contribution of the feltp to the strengthening of the epidemiology curriculum of the mph program in the sph has been acknowledged by both graduates and the ministry of health at several of the school's annual dissemination forum. the current policy of the ministry of health and the veterinary services directorate of deploying graduates of the gfeltp in strategic posts in the national public health service clearly shows the appreciation of the competencies and skills of the graduates. the outputs of the residents of the gfeltp have demonstrated the scientific rigor that has characterized the field investigations and dissertations that have been produced. two of the members of the initial cohort have submitted their upgraded dissertations for the award of phd in epidemiology as of . the emphasis on scientific writing and communication has also reflected in the oral and poster presentations that residents from the program have made in regional and global scientific conferences. the graduates of the program have all returned to positions with an evolving career structure that is likely to motivate them to remain in the public health service. as part of the new public health institute model facilitated by the international association of public health institutes (ianphi) initiative in ghana, the ghana health service is developing a core public health technical or expert team career path that uses the gfeltp graduates to fill the critical role of epidemiologists at the subnational and national levels as well as along specific disease control or public health program lines. crossover to public health administration track at the top of the path is an option and defined promotion track in keeping with the national public health service policy has been proposed. there is ample evidence of improved public health surveillance and response as well as evidence-based decision making taking place in the national health service following the joint evaluation of surveillance systems, disease dataset analyses, outbreak investigations, public health interventions with more regular reports, information sharing and periodic stakeholders' public health seminars at all levels. there has been a definite strengthening of the public health workforce and increased networking between programs in ghana and with other countries [ ] . the prospect of increasing support from the local stakeholders should see increasing enrolment in the program as demonstrated by the enrollment of nine service professionals, the highest number so far of the five cohorts. this should hasten the attainment of the vision and mission of the program. the major challenge of the gfeltp has been the slow follow up on pledges of the major national stakeholders of the programme in honouring their funding commitments as specified in the memorandum of understanding (mou). this has resulted in limiting the number of qualified residents that could have been admitted into the programme. but from testimonies that all stakeholders have given on various occasions about the value they place on the service provided by graduates of the programme, it is expected that their support should be forthcoming. at the formal public launching and st certification ceremony of the programme on june , the minister of health and the director of veterinary services both emphasized their new policy of utilizing the graduates of the gfeltp in strategic positions in the public health system of the country in order to improve the response to existing public health threats and the emerging zoonotic diseases. these pronouncements encourage our optimistic view regarding the programme sustainability based on continuing support from these key indigenous stakeholders. there is no doubt that the establishment of the sph and the subsequent addition of the gfeltp in ghana has contributed significantly to addressing the competency and skills needs of the public health workforce. this is evidenced by the large number of disease outbreak investigations and the timely response that residents of the programme have been able to carry out to date. in particular, the role that gfeltp team of physicians, veterinarians and laboratory scientists played in the investigation and response to the ai outbreak in ghana in demonstrated the great value of the one health concept and the team approach, which the gfeltp has adopted. the unique feature of the gfeltp that permits trainees to provide service to the public health service even while still in training has made the outputs of the trainees well appreciated by relevant employers. consequently, the demand for the course has been growing. as more local stakeholders' support come on board, it is expected that larger numbers of trainees will be admitted into the programme in order to respond to increasing challenges of growing complex of public health emergencies in the country and the sub-region. wurapa f, afari e, ohuabunwo c, sackey s: contributed to development and design of the concept, writing the article and providing important intellectual content, reviewed several drafts and final approval of the version to be published. clerk c, kwadje s, yebuah n, amankwa j, amofah g, appiah-denkyira e: contributed to revising the article for important intellectual content and factual content from perspective of service partners, and approval of the version to be published. public health workforce: challenges and policy issues implementing integrated disease surveillance and response: four african countries' experience this article on pubmed . afenet. the constitution of the african field epidemiology network health workforce, the crisis we acknowledge the contributions of our colleagues on the field where our residents serve especially the ghana health service disease surveillance department and regional/district directorates as well as the director of veterinary service and the regional/district veterinary offices. we are grateful to peter nsubuga from cdc, atlanta who participated in revising the article for important intellectual content and factual content. the secretarial support of the gfeltp administrative staff is acknowledged. all the authors are affiliated with the gfeltp. no other competing interests declared. key: cord- -j fe qu authors: chen, jiaoyan; chen, huajun; wu, zhaohui; hu, daning; pan, jeff z. title: forecasting smog-related health hazard based on social media and physical sensor date: - - journal: information systems doi: . /j.is. . . sha: doc_id: cord_uid: j fe qu abstract smog disasters are becoming more and more frequent and may cause severe consequences on the environment and public health, especially in urban areas. social media as a real-time urban data source has become an increasingly effective channel to observe people׳s reactions on smog-related health hazard. it can be used to capture possible smog-related public health disasters in its early stage. we then propose a predictive analytic approach that utilizes both social media and physical sensor data to forecast the next day smog-related health hazard. first, we model smog-related health hazards and smog severity through mining raw microblogging text and network information diffusion data. second, we developed an artificial neural network (ann)-based model to forecast smog-related health hazard with the current health hazard and smog severity observations. we evaluate the performance of the approach with other alternative machine learning methods. to the best of our knowledge, we are the first to integrate social media and physical sensor data for smog-related health hazard forecasting. the empirical findings can help researchers to better understand the non-linear relationships between the current smog observations and the next day health hazard. in addition, this forecasting approach can provide decision support for smog-related health hazard management through functions like early warning. smog disasters are becoming more and more frequent and may cause severe consequences on the environment and public health, especially in urban areas. social media as a real-time urban data source has become an increasingly effective channel to observe people's reactions on smog-related health hazard. it can be used to capture possible smogrelated public health disasters in its early stage. we then propose a predictive analytic approach that utilizes both social media and physical sensor data to forecast the next day smog-related health hazard. first, we model smog-related health hazards and smog severity through mining raw microblogging text and network information diffusion data. second, we developed an artificial neural network (ann)-based model to forecast smogrelated health hazard with the current health hazard and smog severity observations. we evaluate the performance of the approach with other alternative machine learning methods. to the best of our knowledge, we are the first to integrate social media and physical sensor data for smog-related health hazard forecasting. the empirical findings can help researchers to better understand the non-linear relationships between the current smog observations and the next day health hazard. in addition, this forecasting approach can provide decision support for smog-related health hazard management through functions like early warning. & elsevier ltd. all rights reserved. smog disasters are becoming more and more frequent and may cause severe consequences on the environment and public health in china. for example, in january , smog had covered the capital of china, beijing, for over days. according to recent statistics [ ] , smog affects more than a quarter of the land and over million people in china. according to virginia hughes [ ] , smog is a health hazard that may adversely affect people's health. sometimes it causes extreme and immediate public health emergency, like the one in london [ ] . therefore, it is necessary to develop a systematic approach to analyze, monitor and forecast smogrelated health hazards in a timely manner. on the other hand, social media as a real-time urban data source has become an increasingly important channel to observe events, trends and sentiment [ , ] . negative comments on smog or complaints about smog-related health conditions from a small group of environment sensitive individuals can diffuse really fast on social media and cause much large scale of discussions and reactions. therefore, social media with its network effects can be used to capture possible smog-related public health disasters in its early stage and provide warnings. in the big data era, various technologies are developed to extract, process and analyze population-level social media contents lists available at sciencedirect journal homepage: www.elsevier.com/locate/infosys data, but few with the purpose of forecasting. previous research [ ] usually collected and analyzed such social media data for monitoring the impacts of nature environment on public health, but there is a lack of systematic approaches for forecasting smog-related health hazards with social media data. moreover, a variety of physical sensor platforms for monitoring smog status, including air quality stations, weather stations and earth observation satellites, are also widely deployed across china for both big cities and small towns [ ] , generating a huge amount of observational data about smog severity. as fig. shows, we propose a predictive analytics approach that utilizes both social media and physical sensors for smog-related health hazard forecasting. it contains two major components: ( ) modeling smog-related health hazards and smog severity with raw microblogging text and network information diffusion records and ( ) forecasting the next day smog-related health hazards using an artificial neural network-based model. to the best of our knowledge, our research is the first study to systematically model and analyze real-world social media and physical sensor data for smog-related health hazard forecasting. firstly, this study can help researchers to better understand the non-linear relationships between current smog observations and the next day health hazard, in which physical sensors alone often fail to capture. secondly, the proposed predictive analytics framework aims to provide decision support for smog-related health hazard management through functions like early warning for the coming smogrelated public health emergency. moreover, we investigate the strengths of social media in smog-related health hazard forecasting. it can contribute more than physical sensors in forecasting the smog-related health hazards when the smog disasters are severe. meanwhile, data about social observations' diffusion in social networks can further improve the forecasting accuracy. on one hand, predictive analytics that are related to smog disasters or other kinds of air pollutions usually investigates the natural observations themselves without considering their related health hazard. here are some examples. merz et al. [ ] conducted a time-series analysis of air monitoring data for the downtown los angeles station to detect the air pollution trends. casado et al. [ ] applied a series of geostatistics and visualization procedures to analyze hourly ozone measurements collected from stations in the southeastern united states, which clearly confirmed the diurnal pattern of ozone fluctuations. van et al. [ ] investigated smog prediction problem in perspective of computational steering techniques which allow an optimal trade off between computation speed and prediction accuracy. on the other hand, most studies that involve smog-related public health problems usually analyzed the impacts of smog on public health, but largely ignored real-time health hazard monitoring and forecasting. they mainly used objective indicators from physical sensors or statistics from hospitals. pope and dockery [ ] conducted an extensive review on the research about health effects of particulate matter (pm)the most harmful component in smog. they focused on the shortterm and long-term pm exposure and its effects on mortality and some diseases. recently, hughes et al. [ ] compared annual case numbers of chronic obstructive pulmonary disease (copd) with smog trends in some cities to investigate the health effects of smog in past years. meanwhile, current studies investigating smog-related public health often adopt small data sets with limited population and time coverage. motley et al. [ ] measured only volunteers' health status to acquire public health information during a smog disaster in los angeles. chen et al. [ ] used hospital visits to analyze health hazard trends under smog disasters, but the records only covered one hospital in beijing during one high-smog period. schwartz [ ] investigated mortality caused by smog disasters, but the research was based on data records from some typical big smog disasters in some big cities. recently, social media including microblogging and social network services provided us real-time and large scale data sets related to public health. lee et al. [ ] and culotta et al. [ ] studied public health issues concerning with flu and cancer by analyzing twitter messages. paul et al. [ , ] mined topics of various ailments, symptoms and treatments from tweets with the ailment topic aspect model. greene et al. [ ] investigated several disease-specific information that was shared and exchanged on facebook. gardy et al. [ ] acquired epidemiologic and genomic data through a social network for the research of tuberculosis. social media has also been applied to track the impacts of natural disasters as it will provide detailed information for situation awareness. sakaki et al. [ , ] adopted twitter data to detect and monitor disaster events including earthquake and typhoon in japan with high probability and timeliness. kongthon et al. [ ] obtained up-to-date information about the disaster damage and the needs of the populace in thai flood. yin et al. [ ] built an information system that utilized twitter messages to enhance situation awareness during various crises and events, including natural disasters. although social media has been widely applied in investigating natural disasters and public health problems, there are very few studies that use social media to investigate smog disasters, not to mention smog-related health hazard. mei et al. [ ] was one of the earliest studies for smog disaster analysis with social media, but it aimed to infer the smog severity in the cities where no air quality stations were deployed, which was not related to smog-related health hazard. our previous work [ ] utilized chinese tweets on weibo to analyze the correlation between smog disasters and public health statuses, but did not study smog-related health hazard forecasting. its prediction model simply approximated the health hazard with physical observations, which aimed at quantitatively analyzing the relationship and generating a standard for rating smog disasters' health hazard. the work presented in this paper actually extends our previous work [ ] from historical relationship analysis to real-time forecasting. our another work [ ] in progress aims at forecasting smog disaster directly with different kinds of data including social media data. it will reinforce our study for decision making under smog disasters, but is quite different from the health hazard forecasting topic presented in this paper. artificial neural networks (anns) are computational models inspired by an animal's central nervous systems, and have been widely used in predictive analytics research. they are capable of learning complex non-linear discriminant functions [ ] , and can help solve public health problems like predicting active pulmonary tuberculosis [ ] and severe acute respiratory syndromes (sars) epidemic [ ] . in our ongoing study [ ] , which applies different social observations and physical sensor observations to smog disaster forecasting, anns with single hidden layer or two hidden layers achieve a little higher performance than random forest and support vector machine. in recent years, anns are further extended with deep architectures. they have been proven to work very well for many complex prediction problems with big data in the fields like computer version, nature language processing and so on [ ] . these theoretical properties and real world applications indicate that anns are able to approximate the relationship between the smog disaster and its health hazard. there have been some state-of-the-art algorithms, such as back propagation (bp) [ ] , to train multiple layers anns for various regression problems. the recently proposed learning algorithm named extreme learning machine (elm) [ ] can train a single hidden layer feed-forward ann at a high speed with high generalization performance. it can universally approximate any continuous target function and effectively solve many real-world regression problems, such as sales forecasting in fashion retailing [ ] . according to some experiments [ ] , the single hidden layer ann trained by elm can achieve higher testing accuracy than some typical methods like support vector machine on many regression and classification benchmarks. however, there is a lack of research which utilized prediction methods, such as anns, to fuse both social media data and physical sensor data for the forecasting of smog-related health hazard. this is mainly due to the lack of ( ) systematic approaches for collecting, modeling and analyzing such information and ( ) efficient prediction framework which can combine features from both social media and physical sensors. this research work addresses two challenges: ( ) smog-related health hazard and smog severity modeling with social media. ( ) smog-related health hazard forecasting using social media and physical sensor data. we propose a predictive analytics framework, as shown in fig. . it has three main parts. first, smog-related health hazard and smog severity are measured using raw social observations and social network diffusion data. second, a health hazard prediction model is built using records of public health index, smog severity index, social network diffusion factor and physical observation, and is further utilized to forecast smog-related health hazards. third, the forecasted and measured smog-related health hazards are applied to support decision making in smog-related health hazard management including real-time monitoring and emergency warning. in our study, smog-related health hazards and smog severity are modeled as two indexes using social media information. definition . public health index (phi) is the sum of total relative frequencies of smog-related health hazard phrases in the current tweets. d-phi is an enhanced public health index that includes consideration of diffusion in social networks. smog severity index (ssi) is the weighted sum of total relative frequencies of smog severity phrases in the current tweets. d-ssi is an enhanced smog severity index that includes consideration of diffusion in social networks. calculation of the two indexes includes five steps. first, both smog-related health hazard phrases and smog severity phrases are extracted. smog-related health hazard phrases are those that are commonly used in weibo (a chinese social media site that is similar to twitter) to complain about health problems that may be caused by smog disasters. according to some smog-related medical studies, smog disasters usually cause nose, eyes and throat irritation as well as heart and respiratory diseases in the short term [ , ] . we collect chinese phrases that are commonly used to complain about these health problems. table (a) presents their english counterpartssome may represent multiple chinese phrases with the same meaning. smog severity phrases are those that are commonly used in tweets to describe the current condition of a smog disaster. based on the study of smog-related tweets, we collect common chinese phrases and define a severity order for each of them, as shown in table second, raw tweets with tags of time and location are gathered from weibo. we partition a city into small grids, and then collect the current tweets of each grid area continuously. in detail, the program calls some apis that enable us to acquire raw tweets (not forwarded) posted in a specified circular area defined by one position and one radius. the program ensures that the grid area is totally covered by the circular area. third, daily relative frequency rf of each phrase is calculated: where t h and t c represent historical and current tweet sets respectively, p represents a phrase, d represents a tweet, f ðp; dÞ represents the frequency of phrase p in tweet d, af ðp; t c Þ represents the average frequency of phrase p in the current tweet set t c , idf ðp; t h Þ represents the inversed document frequency of the tweets with phrase p in the historical tweet set t h . the logarithm function is to scale up the fraction of rare tweets. the above algorithm is derived from the typical tf-idf algorithm [ ] . the difference lies in the replacement of the largest word frequency in current tweet set with the size of current tweet set, which aims at eliminating the influence of other heat phrases on weibo. fourth, phi and ssi are calculated with the relative frequencies of all the phrases: where p stands for the set of smog-related health hazard phrases shown in table (a), p stands for the set of smog severity phrases shown in table (b) and order(p) stands for a phrase's severity order. the calculation of ssi is weighted, because most chinese tweets about smog itself come from experts such as the local environment agency or people who have a good knowledge of smog disaster. usually, they use a fixed word set to describe the severity, and subjective severity level that the words' reflect is unified. in contrast, the health status tweets are mostly posted by common people. the severity level of one description word may vary from people to people. using severity words for weighting may not reflect the peoples' subjective idea about severity, which is what we really want in this study. fifth, social network diffusion is considered to calculate d-phi and d-ssi. on weibo, any of people's actions, including retweet and like, indicates an agreement to the original tweet. therefore, one record of such action is regarded as a duplicated raw tweet, based on which we calculate the network diffusion-based average frequency: where g(d) represents a tweet's total number of retweet and like. once daf is calculated, we use it to replace the average frequency af in formula to calculate the relative frequency rf, and further compute the value of d-phi and d-ssi according to formula ( ). as fig. shows, we develop an ann-based prediction model to forecast the next day smog-related health hazard (phi record) with the inputs including the current and the past air quality observations, meteorology observations and social observations. the inputs of the prediction model contain four kinds of features. the first kind of features (f a ) is extracted from air quality observations, including both air pollution concentrations (co, no , so , o , pm : and pm ) and air quality index (aqi) which comprehensively evaluates the air quality. the second kind of features (f m ) is extracted from records of various meteorological elements, including humidity, cloud value, pressure, temperature and wind speed, all of which have been proven to affect smog disasters greatly. for example, high wind speed and low cloud value usually make smog pollution to decrease in the next day. the third kind of features (f s ) comes from records of smog severity index (ssi) and social network diffusion incorporated smog severity index (d-ssi), both of them represent people's opinions and observations on the current and future smog disasters. the fourth kind of features (f h ) uses the current and recent phi and d-phi records, which enables the model to take the autocorrelation factor of the time-series data into consideration. with all these features, we need to conduct feature selection. on one hand, we should filter out some unimportant kinds of observations such as some specific air pollutants and meteorology elements, as they may be not very predictive for the next day phi or may be quite correlated with some other inputs. for example, we find that o does not improve the prediction much when it is inputted with the other air pollutions. on the other hand, we should find out important records in time line for each observation. for example, we find that only the current records instead of all the recent records are important for wind speed and wind direction. in contrary, for d-phi and phi, both the current records and the records in the past h are useful. in selecting features, a view independent subset searching method is adopted. it does not search all the subsets of the whole feature set ðf a þ f m þ f s þ f h Þ, but finds out proper features from each kind of features individually, which reduce the complexity from jfaj þ jfmj þ jfsj þ jf h j to jfaj þ jfmj þ jfsj þ jf h j . it is reasonable because in our application one kind of features represents one independent view to observe the forecasting target, which means two features from different views will not be highly correlated. meanwhile, we further decrease the search spacing through testing records of each observation in time line from the current to the past. if we find the record at time t À i is not important, the records before that time point will also be regarded as unimportant. the ann-based prediction model is built with a method that searches for the optimum feed-forward ann structure. it contains three components: parameters adjusting, training and testing. we use both elm algorithm [ ] and bp algorithm [ ] for training, and adopt a typical cross-validation strategy which partitions the whole sample set into m complementary subsets in testing. we present the model building procedure with the case of elm which only uses one hidden node layer. first, initial activation function g, hidden node number l and regular parameter c are set. second, input weights a i and bias b i of each hidden node are randomly generated. namely, the input x a r d are mapped into a random feature space in each hidden node: third, output weights β of all the hidden nodes are calculated through regular linear solution. namely, the algorithm minimizes the following objection function with small residual error and output weight norm. where j u j denotes the frobenius norm, h is hidden layer output matrix: have a little smog, a little bad air quality, air is slightly polluted, a little dusty sky have smog, bad air quality, air is polluted, dusty sky, high aqi, high pm : have a severe smog, smog outbreak, air is severely polluted, extremely bad air quality, very dusty sky, extremely high aqi, extremely high pm : À there is no smog, air quality is good, sky is clear, the smog has gone À air quality is very good, sky is very clear and t is training data target matrix: where n is the number of training samples and m is the output dimension. fourth, the trained model is tested. fifth, another setting of parameters g, l and c is adopted and goes to the second step, or the program stops if all the parameter settings have been traversed. the ann that achieves the highest testing accuracy is adopted. the optimum hidden node number l is found by incrementally searching with a stopping condition when the testing accuracy begins to decrease. the case for bp algorithm is quite similar with an additional parameternumber of hidden node layers, but without regular parameter c. in evaluation, we analyze the advantages of incorporating both social media features and physical sensor features, display the improvement brought by utilizing network information diffusion and compare the forecasting accuracies of anns and other regression methods. we also present some forecasting results for beijing and shanghai when they are attacked by big smog disasters. we use physical sensor data and social media data in cities (beijing, shanghai, shijiazhuang, tianjin, nanjing, hangzhou, guangzhou and wuhan) for experiments. both data cover more than one year from may to november . the former contains about million hourly records about air quality and weather, while the latter contains about million tweets with their retweet and like records. meanwhile, the tweet number exceeds , for most days in both beijing and shanghai. in evaluation, the records observed in the current and previous days are used as inputs. the next daily day phi record which quantifies the smog-related health hazard is forecasted and compared against the observed records. we use phi instead of d-phi because information diffusion on the social network will non-uniformly magnify the observation thus making the index less objective and harder to forecast. for social media features, phi/d-phi and ssi/d-ssi records are calculated daily and the records of the current and past days are used, while for physical sensor features, the records are observed hourly and the records before o'clock are used. days without enough tweets, which are caused by weibo api limitations and network failures in data collecting, are discarded to ensure that phi/d-phi and ssi/d-ssi records are calculated based on a high population. finally, samples are generated according to the data processing described in the paper. they are partitioned into a training set and a testing set with a cutting time. through the model building method described in section . . , we get optimized ann structures for different evaluations with different features. for elm, which is a training algorithm for single hidden layer ann, the optimized hidden node number ranges from to , while for bp, the optimized ann structure contains hidden layers with - nodes in each layer. we evaluate the effect of using more hidden node layers, but find that it does not improve the generalization performance as our sample set is not very large. meanwhile, two classic svm regression methods, nu-svr and epsilon-svr provided by libsvm [ ] , as well as random forest regression method provided by sklearn, are also applied for comparison. each experiment is conducted with multiple pairs of training and testing sample sets (partitioned with different cutting times) and each test is repeated multiple times. the average of the results is finally adopted for evaluation. we conduct some data analysis to evaluate the correlations between our features and the forecasting targetthe next day phi. it includes two parts: visual comparisons and statistical tests. fig. displays the records of phi and some of the considered features during two big smog disasters in shanghai and beijing. in the figure, the trends of ssi, d-ssi and d-phi are relatively consistent with that of phi, and the latest pm : record is usually consistent with the next day phi records. the latest aqi record may either be consistent with the current day phi or the next day phi. meanwhile, we calculate the correlation coefficients between the next day phi and the current day ssi, d-ssi, d-phi, pm : and aqi with the data in all cities ( samples). the coefficients are . , . , . , . and . , and their corresponding p values are all less than . in two-sided confidence testing. the above analysis indicates that ssi, d-ssi, d-phi, aqi and pm : are quite correlative with phi, and are indicators to forecast the next day phi. the results in our previous study [ ] can further confirm the above conclusion about the correlation. according to [ ] , both meteorology elements like wind speed and air pollutants like o highly correlate with pm : and are important short-term factors of smog disasters. they can indirectly influence the next day smog-related health hazard. briefly, the next day phi is correlated with our social media and physical sensor features, and it is reasonable to utilize them for smog-related health hazard forecasting. first, we compare the testing accuracies of the health hazard prediction model using different kinds of features. as shown in table , the model using both physical sensor and social media features (p þs) has much lower rootmean-square error (rmse) than that using either physical sensor features (p) or social media features (s). on average, the rmse of p þs is about % lower than p and about % lower than s when single hidden layer anns and elm are adopted for training. the comparison result is similar when multiple hidden layers anns and bp are adopted. second, we investigate the advantages of physical sensor features and social media features, which helps explain why their integration can predict more accurately. all the tested samples are classified into four categories according to smog severity which is evaluated by aqi here. average rmses and relative errors are recalculated for each category, as shown in figs. and . from the figures, we can find out that for the days that are not seriously polluted ðaqi o Þ, physical sensor features can achieve lower rmse and relative error than social media features, while for the days that are severely polluted ðaqi z Þ, social media features perform better. this result is consistent with our common sense, as people post much more tweets in those severely polluted days, which provide more positive samples. actually, according to the statistics, table testing accuracies (rmses) of the health hazard prediction model using different training methods and features. elm-ann and bp-ann represent one hidden layer anns with elm and multiple hidden layers anns with bp. p and s represent physical sensor features and social media features, while the prefix d-means considering network diffusion simultaneously. people posted . % more tweets about smog disasters or smog-related health hazard in days when aqi exceeds than in days when aqi is less than . additionally, we can also find that social network diffusion can further improve the accuracy of social media features for polluted days. it will be discussed in details in the next subsection. in our predictive analytics framework, social network diffusion is considered to further improve prediction accuracy. as shown in table , the rmses with the diffusion factor considered (pþ ds) are smaller than those without the diffusion factor considered (pþs) for most cities. actually, the decrement of average rmse brought by the diffusion factor ranges from . % to . % when different training approaches are adopted. figs. and help explain why social network diffusion can improve prediction accuracy. first, the rmses of ds are less than those of s in the aqi ranges of - , - and z , and the relative errors of ds are less than those of s in all the four aqi ranges. second, in both figures, when compared with p, ds outperforms p in two aqi ranges ( - and z ), while s outperforms p in only one aqi range ð z Þ. this may be because considering retweets and likes enlarges the signal of severe pollution and health hazard, thus reducing the noise in learning the nonlinear relationships. especially, the number of retweets and likes to smog-related tweets becomes larger in extreme weather days when it is either severely polluted or has good air quality. it is confirmed by our statistical analysis to the retweet and like records. when compared with the þ when aqi ranges from to , the days when aqi exceeds have % more highly retweeted or liked tweets (more than retweets or likes), and the days when aqi is less than have % more highly retweeted or liked tweets. the accuracies of the health hazard prediction models using anns, nu-svr, epsilon-svr and random forest, are shown in table . we can find that two anns' methods outperform the svm regression methods and the random forest regression method in forecasting the next day phi, and the single hidden layer anns trained by elm achieve slightly higher prediction accuracy than the multiple hidden layers anns trained by bp. in detail, when only physical sensor features or social sensor features are inputted (p columns and s columns in table ), anns (elm-ann and bp-ann) achieve very similar performance as the other three methods, especially the random forest regression method. however, when both kinds of features are jointly inputted (pþs columns in table ), elm-ann outperforms nu-svr and epsilon-svr for all eight cities, and outperforms random forest for six cities. the average rmse is about . % smaller than that of nu-svr, . % smaller than that of epsilon-svr and . % smaller than that of random forest. meanwhile, when the network diffusion is considered (pþds columns in table ), we can get similar comparison results. on the other hand, we can find that another ann model trained by bp achieves similar accuracy as that trained by elm, which confirms that anns are suitable to in our application of forecasting smog-related health hazard. according to the above evaluation, our forecasting approach with single hidden layer anns, elm algorithm and both types of features achieves the highest forecasting accuracy. we adopt such settings for the evaluation of our approach in real world cases. in this part, the forecasting performance during two big smog disasters in beijing and shanghai are presented. the forecasted phi records and the measured phi records during the two big smog disasters are shown in fig. . the trends of the forecasted phi (pþ s) is basically consistent with that of the measured value (target), and the consistency becomes even higher when the network diffusion is considered (p þds). the results indicate that this method can indeed work for realworld situations. in this study, we propose a predictive analytics framework for smog-related health hazard forecasting using information from both social media and physical sensors, which is helpful for smog analysis but not investigated. in this framework, we first propose a new method for smog-related health hazard measurement based on individuals' smog and health related comments, as well as their diffusions on social media. next, we develop a prediction model that utilizes anns to learn the non-linear relationships between the current physical and social smog observations and the next day smog-related health hazard. fig. . results of smog-related health hazard (phi) forecasting for beijing and shanghai. the evaluation results indicate that the performance of ann together with both social media and physical sensor features is the best among all candidates that we used in the experiments. we also find that social media features provide more predictive information than physical sensor features under the situations when the smog disaster is severe. moreover, such benefit from social media data will be enlarged if we further consider information diffusion on social network. the study also contains some limitations which should be studied on in the future work. one major limitation lies in using social media data for health hazard observations as each of its steps may bring in some errors. for example, we use keywords to find health-related or smog-related tweets, but actually people may use the same keywords in different contexts to mean different things. the percentage of correct tweets after filtering by a keyword mostly ranges from % to % [ ] . we can find some other public health information such as hospital visit records as supplements. meanwhile, the adaptivity of the approach for real world circumstances will also be considered in our future work. on one hand, some visual analytics [ ] functions will be added into our on going demo system. through presenting some similar historical circumstances or forecasting results by different features, the system can provide more information for flexible decision making. on the other hand, a new prediction model that utilizes the data from consistent historical circumstances by understanding the underlying semantic of the data is being investigated. china will establish network to monitor smog's health effects, southern weekly public health: where there's smoke a look back at the london smog of and the half century since using social media to enhance emergency situation awareness microblogging during two natural hazards events: what twitter may contribute to situational awareness real-time disease surveillance using twitter data: demonstration on flu and cancer monitoring and mitigation in the cities of china aerometric data analysis time series analysis and forecast and an atmospheric smog diagram geostatistical analysis and 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science: smog disaster analysis based on social media and device data on the web observing social web for smog disaster forecasting artificial neural networks for nonlinear regression and classification predicting active pulmonary tuberculosis using an artificial neural network prediction of sars epidemic by bp neural networks with online prediction strategy deep learning in neural networks: an overview learning representations by back-propagating errors universal approximation using incremental constructive feedforward networks with random hidden nodes sales forecasting using extreme learning machine with applications in fashion retailing using tf-idf to determine word relevance in document queries libsvm: a library for support vector machines when big data meets big smog: a big spatio-temporal data framework for china severe smog analysis visual analytics this work is funded by projects of nsfc , yb - of huawei and fundamental research funds for the central universities, and ly f of nsf of zhejiang. key: cord- -cw n tm authors: campbell, kendall m.; kaur-walker, kulwinder; singh, sarwyn; braxton, michaela m.; acheampong, cassandra; white, catherine d.; tumin, dmitry title: institutional and faculty partnerships to promote learner preparedness for health professions education date: - - journal: j racial ethn health disparities doi: . /s - - - sha: doc_id: cord_uid: cw n tm by the year , it is projected that % of the us population will be members of minority groups, with no one group being the majority. while there is increasing diversity of the population, there remain significant disparities in morbidity and mortality affecting minority groups, and persistent low numbers of underrepresented students in the health professions. increasing the numbers of underrepresented minority students in health care and decreasing the disparity gap have been a priority for many institutions. increasing diversity requires an approach that not only involves health professions schools but also involves undergraduate institutions, faculty, and other professionals who provide pre-health training to students. in , a group of academic medicine leaders convened the innovators, collaborators, and leaders conference with faculty at institutions across the state of north carolina to discuss ways to improve learner preparedness for health professions education and increase numbers of underrepresented students pursuing health careers. in this manuscript, the authors share results from the conference and how institutional and faculty partnerships can promote learner preparedness for health professions education. the us census bureau projects that by the year , % of the us population will be members of minority groups, with no one group being the majority (https://www.census.gov/ newsroom/releases/archives/population/cb - .html). while us demographic statistics show increasing diversity of the population, there remain significant disparities in morbidity and mortality affecting minority groups, including african americans, hispanics/latinos, american indians and alaska natives, and asian americans, native hawaiians, and other pacific islanders (https://www.nhlbi.nih.gov/health/ educational/healthdisp/about-health-disparities.htm). diversity in the us health care workforce is also limited and lags behind diversity in the population [ , ] . increasing the numbers of underrepresented minorities (urm) in health care may increase health access and care opportunities for underserved groups, as urm physicians are more likely to care for the medically underserved [ ] . urms in the health professions can include black or african-american, latinx, and native american people. creating partnerships among historically black colleges and universities (hbcus), native american serving institutions (nasis), and predominantly white institutions (pwis) can benefit all institutions, as pwis can benefit from hbcu and nasi diversity and resilience, while hbcus and nasis can benefit from pwi resources and infrastructure [ ] [ ] [ ] . even though relationships among pwis, hbcus, and nasis can be strained around issues of social justice, inequities in resource provision, and perceived little desire for such partnerships among pwis [ ] , fostering these relationships is a challenge worth undertaking. the inaugural innovators, collaborators, and leaders (icl) conference, held in november of at elizabeth city state university, in elizabeth city, nc, gathered a diverse group of professionals around the mission of increasing urm student representation in health professions, including medicine, dentistry, nursing, and allied health. the icl conference was funded by an endowment grant and was designed to bring together faculty at hbcus, a nasi, and pwis within the state of north carolina to ( ) discuss the preparation of pre-health majors for health professions education across the state, ( ) build camaraderie through candid discussions addressing the effects of historical inequities while highlighting the unique contributions of each institution towards building the health care pathway for urms, ( ) provide meaningful professional development activities for faculty participants, and ( ) develop a strategy for north carolina hbcus, nasi, and pwis to work collectively to increase the number of urm students entering health professions and graduate programs. the two and a half day conference was organized by the brody school of medicine (bsom) at east carolina university (ecu), a community-based medical school with a mission to improve the health status of people living in north carolina. brody serves as a primary care leader for the state [ ] and seeks to increase access to medical education for minority and disadvantaged students. participating universities included duke university, elizabeth city state university, fayetteville state university, high point university, north carolina agricultural and technical (a&t) state university, north carolina central university, shaw university, st. augustine's university, university of north carolina at chapel-hill, university of north carolina at pembroke, and winston-salem state university. agenda topics for the conference included professional identity formation, unpacking mentoring roles and models, mentoring learners for academic success, disruptive innovation ("do it and write about it"), developing successful scholarship, developing your networking platform, and developing your personal leadership. there was also a chancellors' panel where university leaders shared what they felt makes a successful faculty member. conference details were managed by administrative leadership at bsom (senior associate dean for academic affairs and interim assistant dean for student development and counseling), along with the eastern area health education center (ahec). eastern ahec aims to bridge health care and education for health care professionals and community members in a rural region spanning counties in eastern north carolina. the icl conference was specifically intended to foster relationships among faculty who help prepare minority learners for entry into health professions programs, which include nursing, medicine, dentistry, and allied health. content for the conference included sessions on professional identity formation, mentoring, developing successful scholarship, networking, and leadership. the conference was organized as a series of large group sessions and panel discussions that were facilitated by education leaders across the state, who were identified by conference organizers as leaders in the field. presenters and panelists included a university chancellor, vice chancellor, dean, senior leader in academic affairs, learning skills specialist, and director for stem education, among others. faculty and community leaders with experience in mentorship, pipeline and outreach programs, and educational support needs also shared their expertise with conference attendees. conference attendees included % women, % men, and one attendee selecting a desire to self-describe gender. all attendees were faculty or staff at their respective institutions. race/ethnicity data on the attendees were not captured. academic departments or units represented at the conference included family medicine, diversity affairs, psychology, nursing, natural sciences, basic pharmaceutical sciences, public administration and political science, and pharmacy and health professions. several health professionals attended the conference. of faculty attendees, % were full professors, % were associate professors, and % assistant professors. thirty-six percent reported other professional roles including social work program director, research operations manager, co-chair of a biological sciences department, student services director, health professions advisor, and computer science instructor. sixty-three percent of attendees had between and years of total experience as a faculty member, while % had years or less and % had more than years of experience. in this paper, we share perspectives from the icl conference organized into two groups of themes: institutional-level action, including the need for institutional partnerships, particularly hbcu/nasi/pwi partnerships, and the needs of faculty at each type of institution. based on identification of these needs, we provide recommendations for academic institutions wanting to explore multi-university partnerships and facilitate faculty success in diversifying the us health care workforce. stop the stem (science, technology, engineering, and math) pipeline leakage pipeline programs are designed to provide academic enrichment and exposure to health care and stem for learners across the academic continuum. they can increase the number of underrepresented group members in stem, by promoting learner recruitment and retention [ ] . pipeline programs are supported by evidence that shows increase in both the representation and the success of underrepresented groups in health professions, ultimately leading to increasing numbers of minority health providers [ , ] . despite the success of pipeline programs, concerns have been raised that the stem pipeline is leaking: i.e., learners are not progressing through stem training to enter health careers, and existing programs do not accommodate enough learners to meet the demand [ , ] . specific challenges facing these programs include underprepared students, time constraints, instructional challenges, loss of autonomy, and resistance to change, to name a few. these barriers contribute to unsuccessful instructional practices and further contribute to stem pipeline leakage [ ] . overcoming contributors to the stem pipeline leak in north carolina would require developing processes to control the geographic disadvantage, whereby resources are unequally distributed across the state. this disadvantage is especially compounded in the eastern part of the state, due to low socioeconomic status of residents, health inequities, rurality, and poorer health status [ , ] . resources provided for student success need to be accessible and affordable, as well as reflecting the fact that different challenges exist for traditional and non-traditional students [ ] . variability in students' preparation and prior experience, as well as variability in learning environments, can contribute to students dropping out of stem disciplines. learners need consistent, progressive, and systematic mentoring throughout their academic careers, as well as culturally welcoming and inclusive learning environments that provide the resources and staffing needed for academic success [ , , ] . since many pipeline programs may be hosted by one institution but ultimately prepare learners to continue their education at other institutions, academic institutions have to work collaboratively and be held mutually accountable for learner success and resource support [ ] . this accountability should involve creating strategic partnerships, increasing awareness of pipeline leakage, and tracking progress of diversity in stem programs at the institutional level [ ] . suggestions for addressing the leaky stem pipeline require both institutional action and partnership with the local community. collaboration with the community is important to promote learner success and program completion, as there is much medical school that can learn from community partnerships [ ] . as many pipeline programs attract learners from local middle and high schools, in addition to college undergraduates [ ] , working with school administrators, teachers, and other staff can strengthen the relationships between health professions' schools and the communities which they serve. a holistic approach to learning that takes into account learners' distance traveled (i.e., obstacles that learners had to overcome to reach their present position) in addition to academic performance can identify learner strengths for navigating the pipeline. programs should also recognize that students from underrepresented groups may experience anxiety and other emotional concerns that can negatively impact their academic performance and overall well-being [ ] , and build in processes to address these concerns. furthermore, institutions should recognize that women in stem may have unique needs that are not readily addressed by stem pipeline programs, and create the supportive environment that is needed for their success [ ] . maintaining accurate records, managing data appropriately, and reporting outcomes can help make programs sustainable and replicable and can help stop the leak of minority students from stem disciplines. tracking institutional progress can help individual institutions assume responsibility for improving practices and can provide useful information to potential program funders. increased access to program information, creating strategic partnerships, and programming with data-driven interventions can increase positive outcomes for urm students [ ] . using innovative stem technologies, monetizing teachers' ideas, providing summer opportunities to students, and research project materials to schools may also help with the leaky pipeline. collaborative efforts to create stem days at universities and a certified stem school status may also advance progress towards this goal. for the struggling learner, using integrated multidisciplinary pedagogy in pre-med and pre-health courses may assist in identifying learner needs and mobilizing targeted resources. providing opportunities for pwi, nasi and hbcu faculty to become better acquainted with resource availability and opportunities can foster the growth of partnerships among these institutions. moreover, including hbcus and nasis in inter-institutional collaborations with research clusters and health care system partners at pwis may increase chances for stem involvement among urm learners [ ] . appreciating the differences among pwis, nasis, and hbcus can be the bedrock of productive partnerships. academic leaders should realize that pwis, nasis, and hbcus share the same processes. however, because of different settings, historical injustices, inequity in resource allocation, and limited opportunities, hbcus and nasis face a different set of challenges than pwis [ , ] . similar to the minority tax in academic medicine that causes individual minority faculty to suffer from isolation, lack of mentors, lack of faculty development, racism, diversity pressure and other disparities [ , ] , hbcus, and nasis face the tax of systemic racism that leads to limited resources and low performance expectations. this "hbcu/nasi institutional tax" should be further explored, characterized, and dismantled. leaders of all institution types should work to bring about equitable distribution of resources for these institutions, and combat institutional racism in all areas of the academic environment (recognizing that it may be more prevalent in pwis) [ ] . academic leaders should also offer additional support for hbcus and nasis via funding, personnel, and infrastructure, to build upon the demonstrated success of hbcu medical schools in training black physicians [ ] . at pwis, leadership should incentivize faculty to foster partnerships and collaborations with hbcus and nasis and should develop plans to recruit urm graduates into faculty and leadership positions. senior institutional leadership should also develop research opportunities for minority students to promote research and scholarship. leadership at pwis should study the history of racism and education inequity that impacts underrepresented minorities, to understand the unique challenges that impact this group [ ] . pwi leadership needs to think beyond immediate situations to better understand social determinants of health, racism, and privilege systems that impact urm faculty in the health professions. partnerships around scholarship and research can be profitable and beneficial for pwis, nasis, and hbcus. pwis can collaborate with nasis and hbcus to increase the diversity of their cohorts, but in doing so, they must be culturally sensitive to historical injustices such as the tuskegee experiment and the use without consent of henrietta lacks' cells [ , ] . collaboration allows pwis to access particular funding mechanisms that they would not have been eligible for without the participation of a hbcu or nasi partner institution. this partnership often offers bridge grants and start-up compensation to support new hbcu and nasi faculty research. because minority faculty tend to conduct health disparities research more often [ ] , research partnerships between pwis, nasis, and hbcus can have broader reach and more generalizable outcomes. these partnerships can also positively impact funding to hbcus and nasis, and increase numbers of collaborative publications [ ] . despite a myriad of challenges that stem from limited resources for training, financial inequities, and smaller faculty pools, hbcus and nasis continue to make unmatchable gains for resources provided for underrepresented students and faculty. hbcus and nasis aim to address the barriers to education that underrepresented students and faculty face [ ] . this includes lack of mentors, limited social support, and sometimes lower standardized test performance [ , ] . at these institutions, race-concordant role models send a clear message that minority student success in science and in medical school is plausible and likely [ , ] . at hbcu medical schools, although matriculating cohorts have lower average mcat scores than pwi institutions, graduation rates, residency match rates, and board certification achievement are all on par with the performance of urm physicians who attended pwi medical schools [ ] . academic leaders should recognize that hbcus and nasis oftentimes have perceptions of diversity beyond color, and that faculty diversity of thought influences student learning in a positive way. leaders should increase resources and opportunities for external funding for these institutions, as they are often research leaders in the areas of health disparities and health equity. hbcus and nasis are also educational resources for the nation and can educate the nation on global effectiveness in health care delivery with their rich diversity. therefore, directed support is needed to strengthen student engagement at these institutions, develop intensive course offerings, provide service learning opportunities, and create opportunities for learners to participate in research projects and internships that emphasize critical thinking. a particular value of the learning environment at hbcus and nasis is their emphasis on learning in concert with service to underserved and disadvantaged populations [ ] . hbcus are known for missions that include service to underserved populations and for greater contributions to minority health professionals in medicine than pwis [ ] . these institutions and their graduates work to overcome disadvantages in early childhood education and school quality, lack of role models, financial stressors, bias, stereotyping, and racism. in particular, to combat receiving fewer funding opportunities than pwis [ ] , hbcus and nasis work to develop diverse research portfolios in stem [ ] . regardless of the institution, all faculty need to learn about classroom and research needs in their discipline through faculty development training programs [ , ] . academic institutions should provide career and faculty development opportunities that allow faculty to launch and progress in their careers. faculty development should include time for reflection, supportive mentorship, and frequent feedback. when given the opportunity to reflect and interject personal narratives into teaching and receive meaningful feedback and evaluations, faculty develop compassion, humanistic attitudes, and values that can be transferred to the students they teach [ , ] . appropriate funding, staff, and other resources should be provided to ensure faculty success. junior faculty should be supported to develop an academic area of expertise by writing grants, publishing papers, and engaging in collaborative research projects, as these endeavors can lead to increased funding for the institution [ ] . faculty should be encouraged to be innovative, trained in the skill of negotiation, serve as role models for other faculty and students, and be aggressive yet humble in their dedication to learners and the mission of the institution. faculty should use peer mentoring and teamwork in order to develop new skills and address problem areas [ , ] . it is important for faculty to appreciate the importance of research and scholarship for their professional growth and the growth of their students. faculty would benefit from training early in their career on how to generate research ideas and collaborate with colleagues. peer networks around research ideas and across institutions should be developed and sustained to support inter-institutional collaboration. nontraditional funding streams should be pursued, and institutional efforts to streamline processes for institutional review board and other approvals for research should be prioritized. academic institutions should deploy resources to overcome administrative challenges to conducting research, such as inadequate laboratory space or personnel. furthermore, adequate funding and staffing for faculty research may facilitate and promote student engagement in research projects [ ] . core resources for research, training in research, streamlining research infrastructure, recognizing faculty efforts, and providing opportunities for career advancement all contribute to whether a faculty member will successfully engage in research. moreover, institutions' ability to recruit, develop, and promote faculty researchers will determine whether departments successfully embrace new techniques and technologies [ ] . mentorship has been found to bring benefits not only to the mentee but to the faculty who work with them. faculty who mentor students have a better relationship with their students, may have more diverse ideas for research projects, and may be viewed more favorably for promotion and tenure [ ] . faculty should be provided with basic mentoring tools such as literature on mentoring, resources on how to mentor, protected time for mentorship, and funding support to mentor students and peers successfully. faculty should have opportunities to learn how to approach the challenges of mentoring relations, how to utilize the products of mentoring for scholarship and research, and how to overcome common barriers that interfere with an effective mentoring relationship, including factors related to the duration of the mentoring relationship, the number of students served, the structure of the mentoring program, student demographics, and faculty interest [ ] . mentorship models that foster success for both mentors and mentees should be explored with all faculty members, with a focus on project development, research methods, and establishment of infrastructure support that is equitable and effective [ ] . mentorship training should include how to mentor learners across different cultures and backgrounds [ ] . specific mentorship for underrepresented faculty should be considered to address the minority tax, microaggressions, bias, and how to best approach race discordant mentorship relationships [ , ] . minority faculty at pwis urm faculty need to be aware of institutionalized racism, diversity pressures, and nonacceptance of their varied backgrounds and cultures [ , ] . school leadership needs to support the professional competency of urm faculty, ensure that promotion and tenure guidelines are clear and accessible, and provide resources for building scholarship. faculty need assistance from the institution to find mentors and role models, confront negative perceptions that often come with being a member of a minority group, and plan how to maintain personal and professional identities [ ] . they should be supported to have academic freedom and freedom of expression in the workplace, along with emotional support and support to deal with negative comments and behaviors directed towards them [ , ] . senior leaders at pwis should lead the charge in support and resource provision [ ] . in addition, they should employ purposeful processes to promote the retention of underrepresented faculty and undergo training opportunities to better understand how to support underrepresented groups [ ] . faculty at hbcus and nasis faculty at these institutions need leadership support and resources to overcome the multi-role challenge of being a teacher, advisor, mentor, researcher, clinician, and scholar. junior-level faculty should not be placed in administrative roles early in their careers as it may lead to promotion disparities due to having less time for scholarship and publications, which are needed elements for advancement [ , ] . in addition, faculty should not be over-worked. leaders should strive to increase research support, resources, and infrastructure, and expect scholarly productivity that is commensurate with the protected time and resources that are made available to faculty. supervisors should receive mentorship on research and scholarship to provide appropriate guidance in these areas to junior faculty. furthermore, research efforts should be viewed as important and equally as valuable as teaching and service. regardless of appointment at a pwi, nasi, or hbcu, faculty should have clear communication from senior level administrators and department chairs, as faculty often lack guidance on institutional support and resource availability [ ] [ ] [ ] . resources should be deployed to individual faculty for support and not only provided to the department chair or a senior administrator. faculty should be compensated for their work, and their assignments should reflect their expertise [ ] . their opinions and "on-the-ground" experience should be valued, as oftentimes administrators do not engage in research and may not be aware of the challenges faced by the junior faculty. leaders should provide mechanisms for data collection and reporting to track institutional progress and guide the future direction of the institution. leaders should also mobilize mentors at other institutions to jumpstart innovation and productivity. finally, leaders at all schools should monitor and share the progress of well-prepared students who graduate and join the health care workforce, support minority grant awards, and development of new pedagogies to sustain the pipeline training students from underrepresented groups to begin their careers in stem. the icl conference provided suggestions to assist faculty who are supporting students interested in pre-health careers as well as suggestions for hbcu/nasi/pwi multi-institutional partnerships. the initial work of this conference led to the formation of an icl steering committee, which was populated from conference attendees interested in continuing this work. a subsequent meeting of the steering committee was held in to discuss conference outcomes in the light of conference objectives, develop a plan for writing this manuscript, and share results with stakeholders and partners. subsequent planning continues but has been slowed due to the coronavirus pandemic. while this was a small-scale, inaugural event, information concerning the icl conference and other diversity-related outreach efforts are found on the website of the office of diversity affairs of the brody school of medicine [ ] . this resource also includes outcomes data for pipeline and outreach programs aimed in increasing numbers of underrepresented minorities in medicine. further work is needed to create and grow institutional partnerships 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minorities who are conducting hiv rese a r c h retention of underrepresented minority faculty: strategic initiatives for institutional value proposition based on perspectives from a range of academic institutions the experiences of underrepresented minority faculty in schools of medicine challenges in recruiting, retaining and promoting racially and ethnically diverse faculty releasing the net to promote minority faculty success in academic medicine research resources survey: radiology junior faculty development perceptions of academic administrators of the effect of involvement in doctoral programs on faculty members' research and work-life balance research in academia: creating and maintaining high performance research teams meeting our diversity mission publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgments the authors would like to thank elizabeth city state university and eastern area health education center (ahec) for their support and contributions.availability of data and material content presented in this manuscript was obtained through the innovators, collaborators, and leaders conference. key: cord- -s zdmf u authors: dettori, marco; pittaluga, paola; busonera, giulia; gugliotta, carmelo; azara, antonio; piana, andrea; arghittu, antonella; castiglia, paolo title: environmental risks perception among citizens living near industrial plants: a cross-sectional study date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: s zdmf u the present work is a cross-sectional study aimed at assessing the risk perception and evaluating the community outrage linked to environmental factors among a self-selected sample of citizens living in an area characterized by the presence of industrial structures of high emotional impact. an anonymous questionnaire was administered to the population by publishing a google form url code in local and regional newspapers and via social media. the resulting data were entered on excel and analyzed. qualitative variables were summarized with absolute and relative (percentage) frequencies. the results showed that the event that causes the greatest worry was air pollution, with . % of the respondents stating that they perceived the problem as “very” or “quite” worrying. furthermore, all the health problems investigated in relation to environmental quality aroused concern among the interviewees, with . % believing there was a cause-effect relationship between environmental quality and health. overall, as other studies had previously underlined, the survey shows that the perceived risks are not always in line with the real ones, thus, it is imperative to articulate interventions aimed at offering the population objective tools to enable them to interpret the risks themselves. in this regard, a fundamental role is played by adequate communication between the competent bodies and political decision-makers and the population. the relationship between environment and health is of extreme relevance in public health. according to the world health organization (who) [ ] , % of all deaths globally are attributable to environmental factors, and several diseases could be avoided if we lived in healthier environments. in particular, according to the european environmental agency [ ] , poor air quality causes . million premature deaths worldwide, , of which are in the who european region. indeed, the european environment agency [ ] also certifies that noise and air pollution continue to have a serious impact on the health of the population, and human activities (mainly the key sectors of industry, energy, transport, agriculture) are a source of strong environmental pressure [ ] [ ] [ ] [ ] . the growing awareness of the health impacts caused by the alteration of environmental conditions by anthropic activities, such as industrial expansion near urban areas, atmospheric pollution, and climate change, plays a key role in the judgment and acceptability of the risks related to environmental owing to its insularity, the region lends itself very well to observational investigations and represents an excellent test case in relation to the reported social dynamics. in fact, the island has already proven to be well suited to epidemiological studies as it preserves the region from interferences caused by territorial contiguity. as such, it can act as an excellent exercise for the reported social and epidemiological dynamics. in particular, the present study was conducted in the marghine area, a historical region in central sardinia which covers an area of . km and includes municipalities: birori, bolotana, borore, bortigali, dualchi, lei, macomer, noragugume, silanus, and sindia [ ] [ ] [ ] [ ] . figure shows the study area's territorial framework and the population of each municipality in , the year in which observation was carried out, whereas table as shown in figure , several industrial plants (mostly dedicated to the management of solid waste from the entire region) are situated in marghine, located near urban areas, in particular in the municipality of macomer, the main town in the area, with a population of , in . as shown in figure , several industrial plants (mostly dedicated to the management of solid waste from the entire region) are situated in marghine, located near urban areas, in particular in the municipality of macomer, the main town in the area, with a population of , in . [ , ] . in the same industrial zone there is also a purifier that treats the waste water from the waste-toenergy process [ ] [ ] [ ] . finally, the production cycle also includes the management of the controlled landfill, again serving the tossilo plant, located in monte-muradu, in the area north of macomer. although the area is heavily industrialized, the official data published by the health authority and the environmental protection agency have always highlighted parameter values that comply with the regulatory limits, the absence of pollution from the environmental matrices, and excluded an excesses of pathologies in the area of study [ - ]. [ , ] . in the same industrial zone there is also a purifier that treats the waste water from the waste-to-energy process [ ] [ ] [ ] . finally, the production cycle also includes the management of the controlled landfill, again serving the tossilo plant, located in monte-muradu, in the area north of macomer. although the area is heavily industrialized, the official data published by the health authority and the environmental protection agency have always highlighted parameter values that comply with the regulatory limits, the absence of pollution from the environmental matrices, and excluded an excesses of pathologies in the area of study [ - ]. an anonymous questionnaire was built, tested, adjusted, and validated through a pilot study, carried out on a convenience sample of experts in public health (data not published). the internal consistency was assessed with cronbach's alpha test. the questionnaire consisted of close-ended questions divided into two areas of investigation: personal data questions; questions related to health concerns and risk perception. to complete the questionnaire it was required to answer each question. only one question (item no. ) allowed for more than one answer. the questionnaire was administered by publishing a google form url code in the local and regional newspapers (i.e., "il marghine" and "la nuova sardegna"), and via social media (i.e., facebook public profiles of the same newspapers). the questionnaire was to be completed in the period between st september and st december . the full questionnaire is shown in tables and (results section): table reports questions related to the respondents' general information; table shows questions (numbers to ) related to health concerns and risk perceptions, together with their close-ended answers. questions and answers are reported in the first and second columns of the tables, respectively. data were entered on excel (microsoft office, microsoft corporation, redmond, wa, usa) and analyzed using the stata software (statcorp., austin, tx, usa). qualitative variables were summarized with absolute and relative (percentage) frequencies. the differences between mean values for quantitative variables were tested applying the student t-test, whereas for proportions, z test was applied. the independence for qualitative variables was tested applying the x test. in order to evaluate the equality of distributions, kolgomorov smirnov test for two samples was performed. a p-value less than . was considered statistically significant. with regard to the internal consistency, the questionnaire showed a cronbach's alpha reliability test global value of . , which highlights a very good internal consistency. no missing data were managed. during the observation period, residents in the study area voluntarily answered the questionnaire. the respondents' general information related to the first six questions is shown in table . of the respondents, were from macomer, whereas lived in the other municipalities in marghine. as regards the age and gender of the respondents, the average age was . years (± . ), without statistically significant differences between gender, and more than half of the self-selected sample were between and years old. as regards the equality of the distribution by age groups, no differences were observed between genders (combined kolmogorov-smirnoff k-s = . ; p = . ). moreover, . % were female. as regards marital status, most of the respondents were unmarried, and this percentage was in line with that of the general population ( . % and . %, respectively). all age groups had at least one respondent. over % of the sample interviewed had a high school diploma or a university degree, while more than half said they were in employment. finally, . % of the respondents had resided in the study area for over years. the results of the descriptive analysis are shown in table (questions to ). as regards the respondents' perception in relation to the environmental problems reported in question , the results are shown graphically in figure . in particular, the interviewees showed quite a high level of concern regarding all the environmental problems investigated. as the graphic shows, the events that cause the greatest worry are air pollution, with . %, and hazardous waste, with . % of the respondents stating that they perceived the problem as "very" or "quite" worrying, respectively. these latter two figures (air pollution and hazardous waste) seem to significantly differ between genders, with a concern proportion, from quite to very high, of . % vs. . % and . % vs. . %, for males and females, respectively. statistically significant differences for the same two figures were also observed among age groups (p < . ). in particular, the concern seems to grow according to age, ranging from . % in < years old to . % in - years old. in particular, the interviewees showed quite a high level of concern regarding all the environmental problems investigated. as the graphic shows, the events that cause the greatest worry are air pollution, with . %, and hazardous waste, with . % of the respondents stating that they perceived the problem as "very" or "quite" worrying, respectively. these latter two figures (air pollution and hazardous waste) seem to significantly differ between genders, with a concern proportion, from quite to very high, of . % vs. . % and . % vs. . %, for males and females, respectively. statistically significant differences for the same two figures were also observed among age groups (p < . ). in particular, the concern seems to grow according to age, ranging from . % in < years old to . % in - years old. the answers to question are shown in figure . in particular, the interviewees showed quite a high level of concern regarding all the environmental problems investigated. as the graphic shows, the events that cause the greatest worry are air pollution, with . %, and hazardous waste, with . % of the respondents stating that they perceived the problem as "very" or "quite" worrying, respectively. these latter two figures (air pollution and hazardous waste) seem to significantly differ between genders, with a concern proportion, from quite to very high, of . % vs. . % and . % vs. . %, for males and females, respectively. statistically significant differences for the same two figures were also observed among age groups (p < . ). in particular, the concern seems to grow according to age, ranging from . % in < years old to . % in - years old. the answers to question are shown in figure . the events that respondents found less likely are war, terrorism, nuclear risk, and addiction, while diseases were considered to be the most likely event. figure shows the results of the answers given to question no. , concerning worries about one's own health regarding environmental determinants. as the figures show, all the health problems investigated in relation to environmental quality aroused concern among the interviewees, in particular tumors and (temporary or permanent) damage to the respiratory tract, without statistically significant differences between gender and age groups. finally, the results of the questionnaire show that . % believed there was a cause-effect relationship between environmental quality and health (question no. ), . % believed that the environmental situation in the area was serious (question no. ) and % believed that citizens do not have an influential role in decisions made by the municipal administration (question no. ). question number revealed the respondents' main sources of information (more than one answer was allowed) and the answers are shown in figure . as can be seen from the graph, the internet was found to be the most widely used source of information, as opposed to consulting political decision-makers, municipalities, and the regional agency for environmental protection agency (arpas). finally, question number highlighted the willingness of over % of the interviewees to relocate away from their place of residence. the events that respondents found less likely are war, terrorism, nuclear risk, and addiction, while diseases were considered to be the most likely event. figure shows the results of the answers given to question no. , concerning worries about one's own health regarding environmental determinants. as the figures show, all the health problems investigated in relation to environmental quality aroused concern among the interviewees, in particular tumors and (temporary or permanent) damage to the respiratory tract, without statistically significant differences between gender and age groups. finally, the results of the questionnaire show that . % believed there was a cause-effect relationship between environmental quality and health (question no. ), . % believed that the environmental situation in the area was serious (question no. ) and % believed that citizens do not have an influential role in decisions made by the municipal administration (question no. ). question number revealed the respondents' main sources of information (more than one answer was allowed) and the answers are shown in figure . as can be seen from the graph, the internet was found to be the most widely used source of information, as opposed to consulting political decision-makers, municipalities, and the regional agency for environmental protection agency (arpas). finally, question number highlighted the willingness of over % of the interviewees to relocate away from their place of residence. the survey enabled an evaluation of environmental risk perception in a self-selected sample of a population living near industrial plants with a high emotional impact. the strengths and weaknesses presented in the study are discussed in this section. during the observation period, people responded to the survey, with female respondents more numerous. this figure is attributable to the fact that in the region, and in the area subject to observation, the female population outnumbers the male. furthermore, as is known, the female population is more sensitive than the male to environmental issues. for this reason, the greater frequency of female respondents is in line with what has been reported in other similar surveys [ ] . of the respondents, claimed to reside in macomer. this, on the one hand, is attributable to the fact that the municipality counted almost a half of the population of the entire area observed at the time of the investigation; on the other, the fact that the main industrial plants in the area (i.e., the survey enabled an evaluation of environmental risk perception in a self-selected sample of a population living near industrial plants with a high emotional impact. the strengths and weaknesses presented in the study are discussed in this section. during the observation period, people responded to the survey, with female respondents more numerous. this figure is attributable to the fact that in the region, and in the area subject to observation, the female population outnumbers the male. furthermore, as is known, the female population is more sensitive than the male to environmental issues. for this reason, the greater frequency of female respondents is in line with what has been reported in other similar surveys [ ] . of the respondents, claimed to reside in macomer. this, on the one hand, is attributable to the fact that the municipality counted almost a half of the population of the entire area observed at the time of the investigation; on the other, the fact that the main industrial plants in the area (i.e., waste-to-energy plants, landfills, and purifiers) were in close proximity to the town center could explain the citizens' greater sensitivity toward this investigation. as far as the self-selected sample's general information is concerned, over half of the respondents were aged between and years, with an average age of . years. in particular, with regard to the population of sardinia (average age of . years), and of marghine (average age of . years), the respondents were younger. nevertheless, approximately % of those surveyed said they had lived in the area for more than years. although, on the one hand, the way the questionnaire was administered may have favored a response by people more inclined toward the use of it tools, on the other hand, all age groups are represented in the survey. another interesting result, in line with what has been described on the international scene, was the link between educational qualifications and perception of environmental risks. looking at the sample of respondents to the survey, over % of them had a high school diploma or university degree. as previously stated by carducci et al. and by ozdemir et al. [ , ] , subjects with a higher level of education perceive environmental risks to be higher. in general, there was a clear concern among respondents toward environmental determinants, both in relation to the perception of risks and possible effects on health, with . % of respondents claiming the existence of a clear cause-effect relationship between the state of the environment and health status. consequently, all of the environmental problems investigated worried the majority of respondents. in particular, percentages equal to or even greater than % were observed in relation to the presence of hazardous industries, particularly landfills and incinerators/waste-to-energy plants. as recently observed by other authors [ , ] , these structures play an important role in environmental risk perception in populations exposed to them, and could explain the consequent high level of concern regarding food and aquatic environment pollution, hazardous material transportation, noise, and air pollution, and hazardous waste. as can be expected, these latter are closely related to the presence of industrial plants and may explain the citizens' apprehension about possible industrial catastrophes and long-term damage to health that emerged from this survey. in particular, a very high concern was observed among females and older age groups. these figures confirm the aforementioned statement that females are more sensitive than males to environmental issues. moreover, it seems interesting to point out the higher concern among older individuals. considering the younger mean age of our respondents compared to the general population, this aspect could imply that the real concern could be even greater. moreover, the self-selected respondents were concerned by severe weather phenomena ( . %) and fires ( . %). on the one hand, the catastrophes caused by extreme weather events that have hit italy [ ] and sardinia [ ] in recent years have certainly influenced the current fear of such an event. on the other hand, the concern about fires is not surprising, given that these events are frequent in the region [ ] . it is also interesting to note two peculiar conditions declared by the interviewees. first, although sardinia is a region with moderate seismic hazard [ ] , more than half of the respondents ( . %) said they were worried by earthquakes. this particular fact could be traced back to the seismic events occurring in central italy starting from [ ] which were most likely, according to the dynamics of availability bias, responsible for people's tendency to base their judgments on recent information, forming opinions conditioned by the latest news acquired [ , ] . second, a factor that caused little concern was terrorism. in this case, contrary to what was described above, a terrorist cell had been uncovered in macomer shortly before the present investigation [ ] , proving the gap that can be found in a population between the perception of a risk (outrage) compared to the real danger (hazard) [ , ] . with regard to road or work accidents, however, a mixed feeling of exposure emerged from the investigation. on the one hand, in fact, respondents showed a high perception of the risk inherent in road accidents. in this case, as found in accordance with the investigations proposed by the italian national statistics institute and by congiu et al. [ , ] , this phenomenon not only represents a known public health problem, but is also increasing if we take fragile categories into consideration. on the other hand, however, the scant perception of the danger inherent in accidents at work could be attributed to the fact that almost % of the volunteer participants were unemployed, students, housewives, or occasional workers. as for the perception of the environmental quality of the area of residence, although the official analyses carried out by the regional environmental protection agency of sardinia excluded the presence of pollutants in the environmental matrices at the time of investigation [ ], and excessive numbers of disease cases have not been reported by health authorities [ ], the concern of respondents is tangible. nevertheless, a possible determinant of the outrage could be identified in a controversy that arose in the territory understudy at the end of . in fact, at that time the conversion of the incinerator into a waste-to-energy plant had started and an environmentalist association was in opposition to this transformation. this association claimed that there was an excess of pathologies and specific mortality caused by tumors in that territory. the data on which this position were based derived in part from some incorrect health statistics that had been published in that period [ ] , in part from an incorrect reading and interpretation of available epidemiological data. not even the subsequent correction and publication of correct data [ , ] was able to quell the controversy and judicial investigations were also initiated which had no effect and the waste-to-energy plant was set up. even some time later, the sense of bewilderment so clearly raised by the numerous newspaper articles that appeared in the local media for several months still remains strong. this fact could explain why the concern for an excess of tumors was high in both sexes, without significant differences. as jonathan swift said, "falsehood flies and truth comes limping after; so that when men come to be undeceived it is too late; the jest is over and the tale has had its effect" [ ] . this situation is aggravated by the fact that most respondents (over %) believed that citizens do not play an influential role in the decisions made by the municipal administration. in fact, as highlighted by peter sandman himself [ ] with the aforementioned outrage theory, the perception of a risk increases when the situation that generates it is independent of one's will and is attributable to third parties. furthermore, over % of respondents declared the will to relocate. this figure appears to be in contrast with the sardinian people's well-known sense of belonging and attachment to their land, as well as antithetical to the fact that almost % of the replies had been residing in the area for more than years. nevertheless, since the question referring to the will to relocate in relation only to the perceived environmental risks is not explicitly asked, there could be social, economic, and cultural dynamics behind this desire to move away. the present study has evaluated the role of environmental risk perception among a self-selected sample of citizens living in an area where industrial plants with high perceptual and emotional impact are situated. in particular, as other studies had previously underlined, the study shows that the perceived risks are not always in line with the real ones, if we think of how, for example, the respondents answered regarding fear of earthquakes, highly unlikely events in the territory under observation. thus, it is imperative to articulate interventions that are aimed at offering the population objective tools to enable them to interpret the risks themselves. in this regard, a fundamental role is played by adequate communication between the competent bodies and political decision-makers and the population. moreover, the study also revealed how the process of participation in decision-making is one of the determining aspects that influences a person's environmental risk perception, and promoting citizens' involvement in decisions can strengthen their sense of belonging, attachment to the territory, and empowerment. in fact, any action on the territory and even more so its protection (and consequently the perception of the risk linked to the action) that does not stem from an involvement of the local community, is in vain, as it is not legitimized by the context [ ] . starting from the results of the survey, although the study is descriptive in nature and, therefore, requires further investigation in order to better understand the dynamics underlying the high outrage found, some practical actions could be implemented. these should not only concern informing and educating citizens, but should also be addressed to health authorities and institutions (municipalities). in particular, the results of this survey could be very useful for the launch of projects in the area that see the active participation of citizens in decision-making. for this reason, it will be necessary to bring into play multiple professional skills, not only public health professionals and sociologists, but also designers, planners, and urban planners. in addition, an important role is played by journalists, who are responsible for informing citizens. as known, the mass media are often responsible for riding the wave of news stories that attract the attention of readers as they are fueled by an emotional component [ ] . for this reason, it would be appropriate to implement a training project that also involves this category of professionals. finally, a reflection in light of the pandemic that the world is currently experiencing opens up interesting prospects for this study. indeed, it is worth questioning whether the desire to leave the territory studied in this paper is not quenched precisely because low population density is perceived as a less effective medium for the spread of viruses such as sars-cov- , and as such the condition of "urbanity" is not such a great benefit now, nor in the future [ , ] . preventing disease through healthy environments. a global assessment of the burden of disease from environmental risks healthy environments for healthier people the attendees of the th course urban health. strategies for disease prevention and health promotion in urban areas: the erice charter healthy design and urban planning strategies, actions, and policy to achieve salutogenic cities global impact of air pollution on children's health global, regional, and national causes of under- mortality in - : an updated systematic analysis with implications for the sustainable development goals avino, p. pm and pm . qualitative source apportionment using selective wind direction sampling in a port-industrial area in civitavecchia health and environment: communicating the risks. who regional office for europe. copenhagen: who regional office 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• rapporto arpas gestiti dalla società tossilo spa promoting a rules-based approach to public participation environment and health: risk perception and its determinants among italian university students the impact of higher education on environmental risk perceptions a calculation model for improving outdoor air quality in urban contexts and evaluating the benefits to the population's health status le città e i territori alla sfida del clima alluvione sardegna: anni fa morti publications office of the european union: luxembourg primi elementi in materia di criteri generali per la classificazione sismica del territorio nazionale e di normative tecniche per le costruzioni in zona sismica rischio sismico-terremoto centro italia illusory correlation in observational report arrestato in sardegna presunto terrorista: preparava attentato con sostanze tossiche social deprivation indexes and anti-influenza vaccination coverage in the elderly in sardinia, italy, with a focus on the sassari municipality incidenti stradali in sardegna built environment features and pedestrian accidents: an italian retrospective study nuovi dati aggiornati sulla mortalità per tumore aree industriali the examiner no. tutela ambientale e progetto del territorio: integrare, incrementare, interagire why italy first? health, geographical and planning aspects of the covid- outbreak deaths in sars-cov- positive patients in italy: the influence of underlying health conditions on lethality this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the authors would like to thank emma dempsey for the english language revision. the authors declare no conflict of interest. key: cord- -xu h ac authors: berlinguer, giovanni title: bioethics, health, and inequality date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: xu h ac nan first, the technique of preimplantation genetic diagnosis (pgd), which was introduced after in-vitro fertilisation (ivf), allows recognition and elimination of an embryo with a genetic disorder or malformation and permits selection of sex. the international bioethics committee (ibc) of unesco (united nations educational, scientific, and cultural organization) recommended that "pgd be limited to medical indications. therefore sex selection for non-medical reasons is considered to be unethical." nevertheless pgd is also practised, and sometimes morally and legally justified, in developed countries. the debate in frontier bioethics concerns mainly the right of parents to decide the characteristics of their children. sex selection, however, is widely put into practice not only through elaborate technologies but also in daily life through infanticide, discrimination in nutrition and health care, and other barbarous methods. in , amartya sen showed the existence-on the basis of changes in the ratio of women to men in the total population of asia and africa-of hundreds of millions of missing women caused by similar actions. worldwide indignation and appropriate cultural and legal measures have been taken in several countries to reduce this situation. did anything change? sen revisited the data in , and reported that the reduction in female overmortality has been counterbalanced by the spread of sexselective abortion against the female fetus, and as a result the number of missing women is now greater. embryos, fetuses, or babies can be selected by many methods from different cultures, which manifest a unique and crude tendency-this selection is a sharp and visible aspect of gender inequality. in developed countries, acceptance of sex selection through biotechnological methods can hinder any effort to reduce any kind of sex selection in any part of the world. second, the question of whether the human body be bought and sold has a history as long as the existence of slavery, and has been a very embarrassing problem for philosophers, from aristotle to locke, and for theologians. the antislavery movements finally imposed its abolitionone of the most impressive cases of a turn in history by effect of moral principles. it led to the geneva convention (sept , ) , which called on all nations to pursue the suppression of slavery in all its forms, as soon as possible. but in many places, old and new forms of slavery still exist, including bonded labour, in which a worker or labourer is bound to a company or a landlord for life by inextinguishable debts. a type of such bonded slavery existed in the villages of sultanpur mela, kot momin, and mateela in pakistan. in this case, peasants-almost one in every family-sold one of their kidneys for less than us$ . specialised hospitals transplanted their organs into rich patients coming from different cities and other countries. the peasants were obliged to become rewarded donors for the hope or the illusion to free themselves from debts. in this way, slavery met the biotechnological market of spare parts of human bodies. such rewarded donation is the dark side of the enormous advantages coming from the possibility to transfer, from a person to another, organs, corneas, tissues, cells, gametes, stem cells, and other commodities. the moral question "is there a freedom to sell his own body?" was answered, to a certain extent, long ago by immanuel kant (man cannot be at the same time a person and an object; therefore we cannot sell any part of our body) and by john stuart mill (man has all the liberties, except that of choosing to be a slave). now the debate has been reopened. the june, , edition of the journal of medical ethics was dedicated to supply of organs for transplantation, and particularly to the moral legitimisation of the biotechnological market. in my opinion, the question would be most clear if raised the other way round: has a person the right to buy (or to rent) parts of the body of another human being? robert evans, a uk labour member of the european parliament, answered no, and proposed to declare illegal and punishable such practice, according to which wealthy people "are able to exploit desperate people with no fear of penalties". if the answer to this question is yes, the risk is to legitimise a society in which everything could be bought; ourselves, too, who would be regarded as the final commodity. third, prevailing opinion on human cloning is mainly in favour of the cloning of cells and tissues for therapeutic reasons but is against reproductive cloning because this technique denies the casual combination of genes, restricts individual freedom, and implies genetic predetermination. the few people who are in favour of reproductive cloning affirm that human beings are almost always largely predetermined insofar that they are born in a particular country, time, class, and family. if a person's destiny is to become social, cultural, and moral clones, why should genetic cloning not be permitted? perhaps human liberty and self-determination should prevail over all limits and obstacles, either due to social and gender injustice or manipulation of minds; use of science in favour of genetic arrogance would deny or discourage the daily efforts of any person to build autonomously his or her own future. can we develop universal principles in bioethics? these and similar cases could stimulate the debate and (i hope) growth, by consensus, of common universal values in bioethics and of moral norms, accompanied (sometimes) by legal international regulations. this action becomes necessary for two additional reasons. first, many scientific practices have extended beyond national borders, such as the legal (and sometimes illegal) importation and exportation of stem cells, tissue collections, organs, dna samples, and genetic data. moreover, human experiments are done in several countries, and we should avoid putting unnecessary burdens on poor people and communities or creating new forms of exploitation. the bioethical issues that are generated need fair solutions, in accordance with the plurality of values and with the common interests of the world community. second, positive actions for health are essential on a world and local scale. the idea that the combination of scientific progress and free market would spontaneously extend its benefits worldwide, which was dominant in the past two decades, has failed, and a paradoxical situation about science has arisen. new, impressive advances in biomedical knowledge, which at some times in the past were largely accessible-eg, in the s and s, use of antibiotics against microbial diseases and vaccines against smallpox and poliomyelitis-are now becoming more and more selective. many individuals affected by aids or other serious infectious diseases can benefit from new drugs and survive; however, most people cannot afford to pay for the drugs and could die. in africa and other areas of the world, aids could lead to catastrophic effects similar to those the black death caused in europe in - . according to roy porter, "plague killed a quarter of europe's population-and far more in some towns; the largest number of fatalities caused by a single epidemic disaster in the history of europe. this provoked a lasting demographic crisis." the differences are in the progress of the aids pandemic, which is slower than that of the black death but equally cruel, and in the fact that now we know the causes and possible remedies for aids, malaria, tuberculosis, and other scourges. the eradication of smallpox, the substantial reduction of childhood diarrhoeal deaths, and the elimination of poliomyelitis in countries show that www.thelancet.com vol september , wellcome library, london rights were not granted to include this image in electronic media. please refer to the printed journal. many goals have already been achieved through knowledge and common action. unfortunately, the undesired but foreseeable result of medical progress tends to increase inequalities, because it is oriented by vested interests and directed towards the rich instead of general goals. annette flanagin and margaret a winker wrote: "the contemporary era of globalization, which was anticipated to capitalize on advances in technology, science, communication, and cross-national interdependence, has been accompanied by gaps . . . and wide disparities in societal resources . . . moreover, only a small fraction of funds for biomedical research is dedicated to research that affects most the poor or supports research conducted by resource-poor scientists and for the benefit of resource-poor populations." the / gap refers to the fact that only % of the us$ billion spent on health research and development by the private and public sector is used for research into % of the world's health problems. a similar (or greater) imbalance exists for expenditures on prevention and health care. benefit-sharing and equal access to advances in biomedical science are now urgent and universal issues. this moral change in values and priorities should guide public policies on health at all levels. if we think of universal principles in bioethics, the fundamental ones should probably be equal dignity of every individual and equity of life, disease, and death. a step towards universal principles-on a european level-is the convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine, adopted by the council of europe in oviedo on april , , and opened to the signature of other nations. two fundamental articles state that the convention "shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedom" (article ), and that "the interests and welfare of human beings shall prevail over the sole interest of society or science" (article ). the convention includes articles on the rights of the patient, on equitable access to health care, on respect for private life, on non-discrimination on genetic grounds, on transplants, and on prohibition of financial gains "from the human body and his parts as such" (article ). at its st session in , the general council of unesco-after an explicit invitation of the round table of ministers of science-invited its director general to submit the technical and legal studies undertaken regarding the possibility of elaborating universal norms on bioethics. during and , the ibc of unesco worked on a feasibility study, and concluded in june, , with a report on the possibility of elaborating a universal instrument on bioethics, a declaration that is less binding than a convention. the nd session of unesco in october, , judged setting of universal standards in this area to be imperative and desirable, and invited the director general "to continue preparatory work on a declaration, and to submit a draft declaration at its rd session in , involving from the very beginning states, the united nations and the other specialized agencies of the un system, other inter-governmental and non-governmental organizations and appropriate national bodies and specialists". i know by personal experience in the ibc (in which i was a rapporteur) that to proceed from a feasibility study to a universal declaration on bioethics is almost impossible, but trying is worthwhile. the process of elaboration can be itself a contribution to the ethics debate, to knowledge and participation, as long as the existence of many different ethics, and bioethics in particular, is considered-not as an obstacle-but as an expression of richness and freedom. since the text of the preliminary report of the ibc is now publicly accessible, i will not discuss it in detail. i would only underline that, after the preliminary remarks, its first substantial section deals with health and health care (points , , and ) . it begins with this paragraph: "health has a dual moral value: it is essential for the quality of life and life itself, and is instrumental as a precondition for freedom. when disease prevails, the destiny of a person (and even of a nation) is left to external www.thelancet.com vol september , during the summer of , more than elderly people died in france ap rights were not granted to include this image in electronic media. please refer to the printed journal. factors and powers and may enter into an irreversible vicious circle of regression. the inequality between the rich and the poor-at the level of individuals, communities and nations-is becoming increasingly deeply felt in the area of health and healthcare, thereby contributing to the desperation and injustice that prevail and continue to increase in other health-related fields such as food, income and education." the main difficulty in practising moral principles concerning human dignity and equity in health is that in the past years a singular ethics (and a singular policy) prevailed in the world, which resulted in overturning the health paradigms that had successfully guided public health and health services for one century. the principle that health is a value and an objective of economic development has been replaced by the opposite idea: that systems of universal care represent one of the main obstacles to economic growth. the leadership of national health policies has been transferred from health ministers to economics ministers, and internationally (particularly in developing and under-developed countries) was influenced more by the international monetary fund (imf), the world bank, and the world trade organization (wto) than by who. even when the negative results of their policies in relation to equity became clear, and the action of who (whose president at the time was gro harlem brundtland) succeeded in bringing health back on the world political agenda, the model of the commission appointed by who on macroeconomic and health continues to be that of the influential report of the world bank, investing in health. the model does not include any critical analysis "of currently dominant macroeconomic policies or of the structure and mechanisms that entrench developing countries disadvantage, ill health, and deteriorating services". in this framework, the debate refers mainly to healthcare systems, putting aside the concepts of healthy societies and systems. the idea of the priority of primary health care and of the prevention accessible to everybody has been supplanted by high technologies, even in countries where the resources are minimal. discussions on resources for health have been restricted to monetary aspects, ignoring the many possibilities of human resources, of changes in environment and workplace, and of improvements in nutrition and education. the need to identify priorities and to distribute fairly the resources for health care is replaced by the idea of rationing them: not through priorities and universal inclusion, but through selective exclusion. the analysis of diseases' causes has been concentrated mainly on individual factors, such as genes and behaviours, whereas the role of social factors, so important for disadvantaged people, has been neglected. the role of social factors is sometimes even concealed. one example is in the world health report ( ). another example comes from the death, during the summer of , of more than elderly men and women in france, many of them poor or socially marginalised; of more than in germany and italy; and of others in many other european countries. it is true that in august the temperature in these countries was unusually high, but this risk had been widely described in epidemiological research, and preventive measures for elderly people in such conditions are available in almost all gerontology textbooks. the almost unanimous comment of the media was that they were killed by the heat. commentators forgot the isolation, loneliness, lack of attention by many family doctors and local health services, absence of any warning or information being broadcast on television (which is often the only communication between non-self-sufficient elderly individuals and the rest of the community), and insufficient funding for active assistance and care at home. the ministers of health were surprised by the events, and local health authorities tried to underestimate and even to conceal numbers (almost like the epidemic of severe acute respiratory syndrome in china). very few raised two general questions: what else can we expect for world health from potential climate change, and what should we do about present and future risks? at the end of the s, new political and moral trends began to emerge in the world, and new emphasis was given to health and equity in health. these trends became very influential culturally, although they were politically contradicted by the orientations of the dominant powers. health was reintroduced to the international political agenda. in many countries, researchers have shown a growing interest in health equity, inspired either by their moral and scientific sensitivity, or by evidence. the main efforts were inspired by the attempt to integrate altruism and self-interest, to reconsider health as an indivisible good, and by the refusal of simple charitable transfers of benefits among countries or groups. this is an old idea, now defined as compassionate conservatism, which may include the virtue of ethics but has two faults: ( ) those who are helped are placed in a compromising, dependent position, treated as victims not agents; and ( ) societal rules and structures that generate such social consequences are not addressed. public opinion, nevertheless, became more critical towards inequities in health, probably for two reasons. one is that the inequity in health, which often means life or death, raises higher indignation than other inequities concerning income or material goods. the other is an increased knowledge of reality through public inquiries, books, medical journals, and campaigns. a few years ago, amartya sen, closing in dhaka the bangladesh session of the global equity in health initiative in , said: "information concerning discrimination, torture, poverty, illness, and abandonment helps coalesce the forces opposing these events by extending the opposition to the general public. this is because the people have the capacity and willingness of reacting to other people's difficulties." evidence confirms the willingness of people to help others. millions, mainly young people, are working in voluntary services at home or abroad. often, they combine in their activities two aspects that in the past have been separated and even conflicting: to struggle for collective interests, and at the same time to work daily to help individuals. on the political and cultural scene, the role of civil society and of community organisations has increased almost everywhere. a new generation has emerged that criticises the effects of one-sided globalisation on environment, health, justice, and relations between science and society, which underlines that a better world is possible and demands peace. there are some analogies with the youth movements of the late s, but also three differences that can make this new movement more lasting and more effective: their extension beyond schools and far beyond the usa and western europe; their will to integrate criticism with proposals; and their growing influence on national policies and on international agencies, as we can see from two examples. one example is the victory obtained against the bill of indictment, requested by the multinational pharmaceutical industries to the south african court against nelson mandela and his government, for the crime of producing and importing antiretrovirals by ignoring or violating patents. mandela made the decision to ignore the patent to make therapies accessible for the poor population, in a country where one in nine people is hivpositive. after global criticism from governments, nongovernmental organisations, hiv/aids specialists, and a globalised movement mainly organised through the internet, the pharmaceutical companies decided not to pursue the case. after a bitter struggle between the companies and who, new rules were adopted. it is now possible to suspend or limit the royalties for "intellectual property" in case of widespread epidemics: a partial victory in what could be called, perhaps improperly, conflict between patents and patients. later, in october, , the south african competition commission concluded that the companies "had overcharged for the drugs and had limited their licensing to competitors to try to suppress competition"; and finally, in december of that year, glaxosmithkline and boehringer ingelheim, while still rejecting the accusation, agreed to reduce the price for therapy by as much as %. a door has been opened for new international rules on everyday bioethics. the second example is the wto meeting in cancun, mexico, sept - , , where no agreement was reached on trade in agricultural and industrial products, and the attempt to push decisions on fundamental issues, such as the privatisation of water resources and of health and educational services, completely failed. the consequences of this failure may be contradictory, but surely a new factor emerged: the formation of an alliance between more than developing countries who represent more than half of the world's population, and antiglobalisation movements. developing countries have been deeply divided in the past - years, and have had almost no voice in the international arena. cultural and political antiglobalisation groups had already gained publicity in seattle years ago, and now had common goals with many governments. so far, the main result is the defeat of the proposal to extend rules governing the trade of commodities to the services for persons, such as health and education, and to natural resources. the argument has been that such services affect human rights, are essential for human life and growth, and that nations should decide how to guarantee them to all citizens. the two cases show how far other international agencies such as the wto, the imf, and the world bank, are involved in decisions about people's health, which often is not considered as a value but a variable and uncomfortable element of the economic system. as far as ethics is concerned, the difference is that who does have a moral obligation towards people's health, whereas the wto, the imf, and the world bank do not. during and after the recent change in the who leadership, there was much discussion about its future, such as the stimulating debate in the lancet. at the same time, the connections between health and human security became more evident. the un appointed an ad hoc commission that stated: "in addition to the persistent problems and vulnerabilities with which the world has long been familiar, there is a new wave of dramatic crises at the turn of the millennium related to terrorist attacks, ethnic violence, epidemics and sudden economic downturns. there is also a fear that existing institutions and policies are not able to cope with weakening multilateralism, failing respect for human rights, eroding commitments to eradicate poverty and deprivation, outdated sectarian perspectives in educations systems and the tendency to neglect global responsibilities in an increasingly interrelated world. at the same time, the opportunities for working towards removing insecurity across the world are also larger than ever before." two deep contradictions are now arising. one is the move back to the idea of security, which was historically intended (with mixed intentions and results) to counter the threat of aggression across borders or violence against people. in the th century this concept was deepened and expanded through the experience of the welfare state and through the emergence of new personal and collective rights. the questions are now: what security, and for whom? not only against the threat of attacks and crimes against nations and persons, but also for individuals and their dignity; for human welfare, health, and nutrition; for water and clean air; for the biosphere; and for the interests of future generations. the other contradiction is the policy of governments like the usa that, in the struggle against the threat ofinternational terrorism, choose to use their military and repressive power, without addressing the social, cultural, and political causes that cannot ever justify but might explain the growth of terrorism. from a practical point of view, the results of this policy are dubious at the very least. from an ethical point of view, it restricts the range of individuals who could contribute to society; it might demobilise popular, intellectual, and political energies; it introduces a rigid separation between those who are considered good and those who are branded evil; and it weakens the duties of public authorities and international institutions to face other individual and collective needs. the future of health, health policies, and health equity is strictly connected to the resolution of these contradictions. everyday bioethics: reflections on bioethical choices in daily life letters from prison report of the ibc on preimplantation genetic diagnosis and germ-line intervention: shs-est/ /cib- / . geneva: united nations educational, scientific, and cultural organization missing women missing women: revisited il villaggio dei disperati: qui tutti si vendono i reni (the village of the desperates: here all sell their kidneys) il corriere della sera oct la merce finale: saggio sulla compravendita di parti del corpo umano (the final commodity: an essay on the sale and purchase of parts of the human body). milan: baldini and castoldi attack on organ trade begins with transplant tourists. the times the greatest benefit to mankind: a medical history of mankind global health: targeting problems and achieving solutions convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine (convention on human rights and biomedicine) report of the ibc on the possiblility of elaborating a universal statement on bioethics investing in health: world development indicators the report of the commission on macroeconomics and health: a summary critical appraisal: geneva: who the world health report : reducing risks, promoting healthy life. geneva: world health organization morti da canicola: epidemiologia per non dimenticare challenging inequities in health: from equity to action agreement expands generic drugs in south africa to fight aids who director-general elections-join the lancet debate united commission on human security (ogata s, sen a, co-chairs) what is security? key: cord- -s i mdqe authors: jaguga, florence; kwobah, edith title: mental health response to the covid- pandemic in kenya: a review date: - - journal: int j ment health syst doi: . /s - - - sha: doc_id: cord_uid: s i mdqe background: the covid- pandemic has exerted considerable impact on public mental health globally. with the pandemic rapidly rising in sub-saharan africa including kenya, there is need to provide evidence to guide the mental health response in the region. objectives: the objective of this review is ( ) to describe the mental health response to the covid- pandemic in kenya, guided by the mental health preparedness and action framework ( ) to offer context specific recommendations for improvement of the mental health response in kenya. such information could be useful in decision-making in kenya as well as in the greater sub-saharan africa region. methods: this narrative review is based on information obtained from official government documents released from th march , the beginning of the pandemic in kenya, up to st july . discussion: the covid- response in kenya has no formal mental health response plan. there is an unmet need for psychological first aid in the community. while guidelines for the management of mental health conditions during the covid- pandemic have been prepared, implementation remains a major challenge due to a poorly resourced mental health system. there is no mental health surveillance system in place limiting ability to design evidence-based interventions. conclusion: we propose four key strategies for strengthening the mental health response in order to mitigate the harmful impact of covid- on public mental health in kenya: ( ) preparation of a formal mental health response plan specific to the covid- pandemic with allocation of funding for the response ( ) training of community health workers and community health volunteers on psychological first aid to enable access to support for those in need during the pandemic ( ) scaling up of mobile health to increase access to care ( ) conducting systematic and continuous text message surveys on the mental health impact of the covid- pandemic in order to inform decision-making. the ongoing coronavirus disease of (covid- ) outbreak which was declared a pandemic in march [ ] , has exerted a substantial negative impact on the health and socio-economic structures of countries across the globe [ ] . the disease, caused by a novel severe acute respiratory coronavirus (sars-cov- ) has infected close to million people and resulted in over , deaths globally [ ] . disease mitigating measures such as quarantine, isolation, curfews, lockdowns and travel restrictions have resulted in loss of income, disruptions to daily routines and social isolation [ ] laying the ground for negative mental health outcomes among societies. the world health organization (who) reports that by far, the largest public mental health impact has been in the form of stress and anxiety, and predicts a rise in depression, suicide and substance use in the coming international journal of mental health systems page of jaguga and kwobah int j ment health syst ( ) : days [ ] . according to a recently developed emotional epidemic curve [ ] without adequate mitigation measures, countries will experience two peaks of negative mental health consequences. the first peak is dominated by anxiety and corresponds to the peak in covid- cases. a second peak of negative mental health outcomes comprising of post-traumatic stress disorder (ptsd), depression, suicide, complicated grief bereavement, and relapse of those with existing disorders, corresponds to the post-pandemic period [ ] . given the substantial anticipated burden of mental disorders in the context of the covid- pandemic, it is important that the mental health response is given high priority. the recently developed mental health preparedness and action framework (mhpaf) [ ] provides a useful schema for evaluating and guiding the mental health response during the covid- pandemic. the framework was recently developed by mental health professionals drawn from all six who regions after realization that the who-global influenza preparedness plan (who-gipp) [ ] had no mental health component. the mhpaf is comprised of five interrelated components: ( ) preparation and co-ordination; ( ) monitoring and assessment; ( ) reducing mental health distress and misinformation; ( ) sustainability of mental health care services and ( ) communication [ ] . according to the framework, 'preparation and co-ordination' involves developing a mental health response plan, creating covid- specific mental health services and training of healthcare workers on psychological first aid. psychological first aid is a supportive response that involves offering practical support to persons who are suffering or facing crises. it involves assessing and addressing basic needs such as food, water and information. it further entails listening to people, helping them calm down and protecting them from further harm [ ] . 'monitoring and assessment' requires the development of a mental health surveillance system to enable continuous collection of data on mental health for at risk populations as well as the general population. a second role of the mental health surveillance system is 'reducing mental distress due to misinformation' . this includes monitoring various media platforms for myths and countering them by spreading accurate information. finally, 'sustainability of mental health care services' entails the allocation of adequate funds to help mitigate the burden of mental health disorders during and after the pandemic [ ] . the cases of covid- are rapidly rising in the sub-saharan africa with concerns being raised about its capacity to deal with the pandemic [ ] . kenya, a low middle income country in eastern africa, was listed as being at high risk for importation of covid- at the beginning of the pandemic in africa [ , ] . in addition, kenya has been reported as having a low infectious disease vulnerability index (ivdi) indicating its high vulnerability to the outbreak due to fragile health systems [ ] . as at st july , kenya has , confirmed cases of covid- and deaths [ ] . a member national emergency response committee has been set up and is responsible for overseeing and coordinating the overall covid- response [ ] guided by the national novel coronavirus contingency (readiness and early response) plan [ ] . the plan however offers no guidance on a mental health response, despite direction from the kenya mental health policy - [ ] requiring that mental health care is provided during and after disasters. the ministry of health (moh) through its division of mental health has nonetheless embarked on efforts to deliver mental health care during the pandemic. unfortunately, the mental health response is occurring against a backdrop of an under-resourced mental health care system characterized by inaccessible services, an acute shortage of mental health workers and limited funding [ ] . this, coupled with the lack of a formal mental health response plan is hindering current efforts aimed at mitigating the mental health impact of covid- in the community. given the rising incidents of domestic violence [ ] and alcohol use [ ] during the covid- pandemic in kenya, and the importance of behavioral strategies in containing the pandemic, a stronger mental health response is warranted. the aim of this review is therefore ( ) to provide an overview of the mental health response to covid- by the government of kenya guided by the mhpaf. a literature search revealed no paper describing the mental health response to covid- in a sub-saharan africa country [ ] to offer context specific recommendations for improvement of the mental health response in kenya. such information could be useful in guiding the mental health response in kenya and in other sub-saharan africa countries. the aim of this narrative review is to describe the mental health response to covid- by the kenyan government. documents for review were identified following consultation with experts working at the division of mental health at the moh. we additionally hand-searched the websites of the moh and other ministries that were listed by the government as being key in the covid- response [ ] for documents and web-pages with content relevant to the five components of the mhpaf. in total, documents released between th march when the first case of covid- was announced in kenya, and st july were identified and included for review (table ) . according to the mhpaf [ ] , the mental health response during the early phases of the pandemic should focus on the preparation of a mental health response plan to serve as a guide for actions to be taken during the pandemic. the 'national novel coronavirus contingency (readiness and early response) plan [ ] has no provision for a mental health response. the national disaster response plan, the kenyan government's blueprint for disaster management [ ] has operational objectives relating to mental health. however, some objectives are not specific to the covid- context (for example the plan emphasizes the need to ensure access to social activities such as religious activities and schooling), limiting its applicability during the current pandemic. in order to manage the distress and anxiety often witnessed during pandemics, the mhpaf [ ] recommends that health care workers are trained on how to administer psychological first aid during the early phases of the pandemic. at the beginning of the covid- pandemic in kenya, the division of mental health at the moh prepared a guide for psychological first aid [ ] . training of healthcare workers on psychological first aid using the guide is ongoing via virtual platforms. a health sector situational report on covid- as at th may however indicated that there was an unmet need for psychological first aid in the community [ ] . lastly, 'preparation and co-ordination' entails the setting up of covid- specific mental health services. in kenya, a number of guidelines have been developed by the division of mental health in partnership with professional bodies such as the kenya psychiatric association to ensure provision of covid- specific mental health services. the 'interim guidelines for managing mental health conditions during the covid- pandemic' [ ] is one such document. it provides instruction on the in-patient and out-patient management of persons with mental health and substance use disorders who test positive for covid- . the document additionally outlines the delivery of mental health care for persons in isolation and quarantine, and offers guidance on how to conduct telepsychiatry. in order to ensure continuity and accessibility of mental health services, the same guidelines provide direction on the management of persons with newly diagnosed mental illness and the continued care for those with pre-existing mental illness during the pandemic. the guidelines recommend that health care facilities constitute mental health response teams in order to co-ordinate care during the pandemic [ ] . two other documents that have been prepared by the division of mental health include a guide for health care workers on how to offer mental health and psychosocial support to the public [ ] ; and standard operating procedures for psychologists and counselors to ensure standardized delivery of psychosocial interventions during the pandemic [ ] . a major challenge likely to be faced despite the guidelines is that the number of mental health facilities and mental health workers available in kenya is scarce. for example the psychologist to population ratio is : , , . in addition, less than % of the public sector health care facilities offer any form of mental health care [ ] . using mobile phones to deliver mental health services in kenya during the current pandemic, could potentially overcome the challenges of limited infrastructure as well as ensure compliance with pandemic containment measures. such a strategy is likely to be psychological first aid guide for covid- response in kenya, [ ] kenya situation report of th may, [ ] interim guidance on continuity of mental health services during the covid- pandemic, [ ] a comprehensive guide to mental health and psychosocial support during the covid- pandemic, [ ] frequently asked questions about covid- [ ] public mental health education handout [ ] covid- outbreak in kenya daily situation report- [ ] covid- mental health messages for healthcare workers [ ] standard operating procedures for counselors and psychologists providing mental health and psychosocial support for the covid- response in kenya [ ] ministry of interior and co-ordination of national government the national disaster response plan [ ] page of jaguga and kwobah int j ment health syst ( ) : feasible given that the country has a % penetration of mobile subscriptions. in addition, kenya has the highest share of internet usage from mobile phones as compared to desktops globally [ ] . currently, counseling is being conducted via mobile phone voice calls for persons in isolation and quarantine. in addition, a call centre whose aim is to offer both knowledge and psychosocial support to frontline health workers has been established [ ] . there is however a lack of mobile mental health interventions targeting the general public. the mhpaf recommends the setting up of a mental health surveillance system during the early phases of the pandemic. this is to ensure systematic and continuous collection of data on mental health in order to assist with planning and designing of appropriate interventions [ ] . data collection and monitoring for the covid- situation in kenya is being conducted by the government and daily situational reports are provided by the moh. none of the parameters reported relates to mental health [ ] , a manifestation of a health information system in kenya that does not prioritize collection of data on mental health [ ] . without a system for continuous collection of mental health data, a clear understanding of the burden and risk factors of mental health problems during the current pandemic remains elusive. this may result in a poorly co-ordinated response with inefficient use of the scarce resources. currently in kenya, research studies seem to be the main strategy for collecting and analyzing information on mental health during the covid- pandemic. the authors are aware of on-going online studies that are being conducted by mental health professionals to investigate the burden of mental health conditions among health care workers. an additional role of the mental health surveillance system is the dissemination of accurate and timely information and to address myths surrounding covid- . this has been shown to reduce anxiety and stress during pandemics [ ] . according to the mhpaf some of the information that ought to be relayed to the public includes strategies for promoting and preventing mental health problems, available mental health services and regular updates on the state of the pandemic [ ] . in kenya, the ministry of information communication & technology (ict) has been tasked with communication functions during the pandemic with focus on dissemination of information on covid- , public education and dissemination of health messages [ ] . to achieve this, the ministry has set up toll free lines and hotlines through which the public may call to receive information [ ] . in addition, the ministry of ict in conjunction with the moh has set up a call center whose aim is to provide information on current practices on covid- to health care workers [ ] . the moh has been involved in providing information on covid- to the public. specifically, the moh provides daily situation reports on covid- which usually detail the number of cases, deaths, recoveries and offers key public health messages [ ] . the moh has in addition prepared handouts on frequently asked questions about covid- [ ] , public mental health education [ ] and covid- mental health messages for healthcare workers, for online dissemination [ ] . further, the moh has partnered with a local mobile service provider to provide accurate information on covid- to the general public via a -hour call center. the call center has incorporated the services of medical doctors who offer assistance with technical questions [ , ] . direct funding to the mental health response could not be ascertained. given the lack of a formal mental health response plan, it is likely that funding for the mental health response is erratic and inadequate. in the post-pandemic period, kenya should conduct a thorough evaluation of the five components of a mental health response as outlined in the mhpaf. lessons learnt should be utilized in preparing a well co-ordinated mental health response plan specific for pandemic situations. kenya has made attempts at instituting a mental health response to the covid- pandemic despite underlying systemic challenges. however, major gaps remain. the country has no formal mental health response plan, there is an unmet need for psychological first aid, access to mental health care and psychosocial support during the pandemic remains a challenge and there is no systematic collection of data on the mental health impact of covid- . we therefore propose four key strategies for strengthening the mental health response in kenya: to enable access to psychological support for those in distress during the pandemic particularly at the grassroots level. such trainings could be administered remotely via video conferencing given the good internet coverage and smart phone penetration rates in kenya. . scaling up of mobile health to increase access to mental health and psychosocial support for the general public during the pandemic. we propose that the medical doctors manning the -hour call centre receive online trainings on mental health and psychological support following which the service is expanded to incorporate delivery of brief psychological interventions to the general public. . in order to ensure proper surveillance of the mental health situation during the current pandemic, we propose that systematic and regular surveys are conducted to allow for monitoring of the mental health impact of covid- in kenya. major mobile service providers in kenya have survey platforms that use text messaging. these constitute potential means through which mental health surveillance could be conducted. given, the existing partnerships between the moh and local mobile service providers, such an initiative is likely achievable. world health organisation timeline-covid- the socio-economic implications of the coronavirus pandemic (covid- ): a review coronavirus disease (covid- ) situation report- effects of the covid- pandemic on mental well-being amongst individuals in society-a letter to the editor on "the socio-economic implications of the coronavirus and covid- pandemic: a review coronavirus disease (covid- ) outbreak-mental health and covid- mental health interventions during the covid- pandemic: a conceptual framework by early career psychiatrists pandemic influenza preparedness in who member states: report of a member states survey psychological first aid (psycho-logical first aid) guide for covid- response in kenya preparedness and vulnerability of african countries against importations of covid- : a modelling study world health organisation. who ramps up preparedness for novel coronavirus in the african region united nations office for the co-ordination of humanitarian affairs, world health organisation kenya covid- operations dashboard national novel coronavirus contingency (readiness and early response) plan an overview of mental health care system in kilifi, kenya: results from an initial assessment using the world health organization's assessment instrument for mental health systems nacada raises alarm over rise in online liquor sales: daily nation. united nations office for the coordination of humanitarian affairs kenya situation report : • fast, convenient online submission • thorough peer review by experienced researchers in your field • rapid publication on acceptance • support for research data, including large and complex data types • gold open access which fosters wider collaboration and increased citations maximum visibility for your research: over m website views per year • at bmc, research is always in progress. learn more biomedcentral.com/submissions ready to submit your research ? choose bmc and benefit from: . republic of kenya. ministry of health. interim guidance on continuity of mental health services ministry of health. a comprehensive guide on mental health and psychosocial support during the covid- pandemic ministry of health. frequently asked questions about coronavirus (covid- ) public mental health education during covid- pandemic ministry of health. covid- outbreak in kenya daily situation report- covid- mental health messages for healthcare workers standard operating procedures for psychological counselors and psychologists providing mhpss for the covid- response in kenya office of the president. national disaster response plan kenya leads africa in smartphone usage ministry of health. cs ict launched covid- call centre for health care workers providing sustainable mental health care in kenya: a demonstration project providing sustainable mental and neurological health care in ghana and kenya: workshop summary safaricom: , call covid- helpline daily doctor on call: telemedicine takes its place in a pandemic publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations not applicable. fj and ek conceived the idea. fj and ek in consultation with experts identified official government documents with information on covid- and the five components of the mhpaf. fj and ek hand-searched the websites. fj wrote the first draft of the manuscript. fj and ek contributed to subsequent revisions of the first draft. all authors read and approved the final manuscript. there are no sources of funding to declare. not applicable. not applicable. not applicable. the authors declare that they have no competing interests.received: june accepted: august key: cord- - zi xgu authors: r., varalakshmi; k., arunachalam title: covid – role of faculty members to keep mental activeness of students date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: zi xgu nan world health organization (who), declares as on march , , globally , confirmed cases of coronavirus disease , which includes , deceased (https://www.who.int/docs/ default-source/coronaviruse/situation-reports / -sitrep- covid- .pdf?sfvrsn= e fe f _ ; coronavirus outbreak, a,b) . the virus was first identified in wuhan state of china during december and it was started to spread across the globe. the virus will affect the respiratory system with fever and cough (wuhan municipal health and health commission, ) . the world health organization (who) termed this virus as novel coronavirus ( -ncov). though, initial patients were due to animal-to-person transmission and sooner more cases were reported are medical staff and others, indicates human-to-human transmission of virus (liu et al., ) . the virus mainly spread via respiratory droplets from sneezing or cough of infected people during close contact with others. in india, the first case was reported in the last week of january (https://www.indiatoday.in/india/story/kerala-reports-firstconfirmed-novel-coronavirus-case-in-india- - - - ). the outbreak has been declared an epidemic by world health organization (who). to reduce the spread of the virus, the government of india issued the various guidelines include hand hygiene practices, wearing masks, avoiding public gathering, social distancing and quarantines etc. and through different media, the message has been broadcasted to all the people (https://www.livemint.com/news/india/govt-calls-forsocial-distancing-as-confirmed-coronavirus-cases-rise-to- - .html). during the nd and rd week of march , many state government were shut down the educational institutions including schools and colleges upto . . . on . . , as insisted by the prime minister, india has observed a -h voluntary public curfew. on . . , considering the nature of virus spreading, the prime minister of india announced a complete nationwide lockdown, starting from midnight for days till . . (https://www.independent. co.uk/news/world/asia/india-coronavirus-lockdown-modi-speechcases-update-news-a .html). as the health of the nation is very important and social distancing reduce the spread of the virus, the steps taken by the indian government are highly appreciable. from the above facts, it is observed that more than weeks has been declared holiday to the student's fraternity. in general, the classes for the even semester will be held between december to march and in april end semester examination will be conducted. during even semester festivals including christmas, new year, pongal will be celebrated. also, co-curricular and extra-curricular activities including cultural, sports, hostel day, institute day, department symposium etc., are also conducted during this semester. as the part of performance evaluation, internal assessment, model examinations, laboratory examinations, semester examinations etc are also conducted in march. in this present scenario, if the students are not attending the classes, then the students will spend their time in watching television, playing games, internet surfing, chatting etc. the faculty member plays a vital role in keeping the young budding professional in active mode. the students are to be engaged in a proper manner and they have to utilize this time in a productive manner. on . . , the university grants commission (ugc) has issued the circular in connection with ict initiatives of mhrd and ugc (https://www.ugc.ac.in/pdfnews/ _on-line-learning-ictinitiatives-of-mhrd-and-ugc.pdf). these initiatives are highly informative to the faculty members and the students to enhance their knowledge either in their fundamentals course (or) in advanced course (or) in preparing for a competitive examination (or) in a specific field of his / her interest. the initiatives include: their course to the respective students, the following online methods can be adopted for various steps in teaching-learning process. teaching can be either offline or online. in offline mode, the lecture video will be recorded using powerpoint, webcam with good quality noise cancellation microphone. a digital drawing tablet with pen would add value for mathematical teaching, derivation, numerical examples etc. the video can be uploaded in youtube and the link can be shared to the students. the limitation is the faculty member cannot ensure whether all the students viewed the lecture video or not. in online mode, tools like google hangout, skype, zoom etc can be used. the faculty member can schedule an online class and ask all the students to present. this would require a good broadband internet connection for video streaming. the faculty member can able to clarify the doubts raised by the students. after the classes, in order to understand and evaluate the student, online assignments and online evaluation can be made. the quiz can be created using google forms, either multiple choice question or short answer. the faculty members can able to provide feedback, marks secured, instruction etc. with the help of microsoft teams, the students can collaborate and do group assignments, prepare and edit of their project report. for student interactions among themselves, they can use google hangouts, skype, zoom etc. social media like facebook, whatsapp etc., can also be used without invading their privacy. lecture materials, notes, presentation, short videos and other related information can be shared to the students using blackboard, or google classroom, moodle etc. though, many ict tools are widely available (https://en. todaysteachingtools.com/list-of-ict-tools.html), to the best of the knowledge of the authors, a list of ict tools to engage the students actively inside the classroom and outside the classroom are given below (in alphabetical order in this situation, as per the direction of ministry of human resource development (mhrd), india, the faculty member should engage the students academically through online for the benefit of their career. also, the faculty members should engage themselves actively in upgrading their knowledge, writing research papers, attending webinars etc. this will gain their confidence. also, students will be in phase with the academic calendar. this constant student engagement activity will strengthen the teaching-learning and it is sure that it will break the chain of spreading of covid . this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. wuhan municipal health and health commission's briefing on the current pneumonia epidemic situation in our city transmission dynamics of all authors contributed equally. the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. none. key: cord- -rziqtdp authors: bourassa, kyle j; sbarra, david a; caspi, avshalom; moffitt, terrie e title: social distancing as a health behavior: county-level movement in the united states during the covid- pandemic is associated with conventional health behaviors date: - - journal: ann behav med doi: . /abm/kaaa sha: doc_id: cord_uid: rziqtdp background: social distancing—when people limit close contact with others outside their household—is a primary intervention available to combat the covid- pandemic. the importance of social distancing is unlikely to change until effective treatments or vaccines become widely available. however, relatively little is known about how best to promote social distancing. applying knowledge from social and behavioral research on conventional health behaviors (e.g., smoking, physical activity) to support public health efforts and research on social distancing is promising, but empirical evidence supporting this approach is needed. purpose: we examined whether one type of social distancing behavior—reduced movement outside the home—was associated with conventional health behaviors. method: we examined the association between gps-derived movement behavior in , counties in usa from march to april , and the prevalence of county-level indicators influenced by residents’ conventional health behaviors. results: changes in movement were associated with conventional health behaviors, and the magnitude of these associations were similar to the associations among the conventional health behaviors. counties with healthier behaviors—particularly less obesity and greater physical activity—evidenced greater reduction in movement outside the home during the initial phases of the pandemic in the usa. conclusions: social distancing, in the form of reduced movement outside the home, is associated with conventional health behaviors. existing scientific literature on health behavior and health behavior change can be more confidently used to promote social distancing behaviors during the covid- pandemic. the sars-cov- coronavirus originated in wuhan, china, in late [ ] and spread globally over the first months of . human-to-human transmission of sars-cov- was confirmed in january [ ] , and the first case in the usa was confirmed on january . the outbreak of the disease resulting from sars-cov- (covid- ) [ ] was declared a pandemic by the world health organization on march [ ] . by june , , the cdc recorded over million cases and , deaths due to covid- in the usa [ ] , contributing to over . million infections and , deaths worldwide [ ] . in march , u.s. public health and government officials began an unprecedented effort to limit the spread of sars-cov- . owed largely to the lack of effective pharmacological interventions and vaccines, social distancing-a constellation of behaviors that decrease close physical contact among nonhousehold members [ , ] -emerged as the primary mitigation strategy for limiting the spread of the virus. the cdc recommended three specific social distancing behaviors: (i) stay at least ft away from other people, (ii) do not gather in groups, and (iii) stay out of crowded places and avoid mass gatherings [ ] . based on the belief that the less people traveled outside their home, the less close physical contact between infected and uninfected individuals would occur, multiple levels of government enacted limitations on business and movement (e.g., closing schools and nonessential businesses, stay-at-home orders [ ] ) to stymie the spread of the virus. preliminary research found that government actions restricting movement reduced sars-cov- infection rates [ , ] , though peer-reviewed evidence in the usa is more limited. social distancing-also known as physical distancing-is a complex set of human behaviors that will benefit from multidisciplinary study to guide public health implementation [ ] [ ] [ ] . the current pandemic is unique in terms of its impact on social and economic activities in the modern usa. previous viral outbreaks, such as h n [ ] , did not result in the level of mass behavioral change observed in response to covid- . calls for americans to limit their movement outside the home is a novel-and in many ways unprecedentedpublic health effort in the modern usa. in light of the limited empirical research focused on such efforts, lessons learned from more comprehensively studied behaviors may be useful in understanding how to best promote social distancing behaviors. health behaviors like smoking, physical activity, and vaccination rates have been studied by the scientific community for decades, presenting an opportunity to apply relevant theory to promote social distancing [ , ] . for example, theories of individual behavior change provide models helping to explain why individuals choose to engage in, or not to engage in, health behaviors related to a number of medical conditions [ ] . ecological models of health behavior also present many levels of influence (e.g., family, community) that can impact people's health-related behaviors [ ] . it is tempting to apply social and behavioral research on health behaviors to social distancing based purely on theoretical grounds, but the value of this opportunity is limited by whether social distancing behaviors are affected by the same causal, theoretical variables as conventional health behaviors. empirical evidence to this end would support the application of health behavior models to social distancing [ , ] , particularly given the way health-relevant behaviors tend to correlate [ , ] . to the extent that social distancing is associated with more conventional health behaviors, stakeholders could more confidently draw on the broad literature of health behavior change [ , , , ] when studying and promoting social distancing. the present study used objectively measured movement data to examine social distancing behavior in u.s. counties during the covid- pandemic. we hypothesized that counties whose residents evidenced healthier behaviors prior to the pandemic would also show greater reductions in movement during the pandemic. in addition, we predicted associations would remain when controlling for relevant state-and countylevel characteristics. the current study used county-level movement data from march to april , collected by two companies-cuebiq and streetlight data. cuebiq collects movement data from ~ million mobile gps-enabled devices from individuals who consented to have their data collected. these data were then processed and aggregated at the county level to produce daily estimates of movement behavior. streetlight also uses gps mobility data and a proprietary algorithm to produce estimates of daily vehicle miles traveled, which are aggregated at the county level. data from streetlight were made available starting march , , which was defined as the start of the study period. additional data provided by citymapper were used for validation purposes. movement data were combined with county-level health behavior data from the county health rankings & roadmaps. in the current study, we included all counties in the usa that had movement data from both cuebiq and streetlight during the period of interest (n = , ), which included states and the district of columbia. streetlight did not include movement data on counties in alaska (n = ) and hawaii (n = ), or counties in the continental usa. cuebiq did not provide data for two additional counties. supplemental data provides the -digit county identifier, state, and name for all excluded counties (n = ). we did not have access to any individuallevel data for this study. movement behavior was assessed using data from cuebiq and streetlight data. these companies provided county-level data for the primary outcome variables: daily percentage of people remaining within mile of home and daily vehicle miles traveled. supplemental analysis provides an analysis of validity for these measures. for each outcome, we calculated initial change in movement in response to the pandemic by taking the difference between averages over the first days of march and april. daily percentage of people remaining within mile of home cuebiq movement data use gps-enabled devices to determine the greatest distance people travel from their homes on any given day (< ft, between ft and mile, between and mile, and > mile). daily data are aggregated at the county level, resulting in a percentage for each category. we calculated the total daily percentage of people who remained within mile of home. increases in the percentage of people remaining within mile of home indexed relatively more social distancing behavior. daily vehicle miles traveled streetlight movement data estimate the daily vehicle miles traveled by residents of each u.s. county in the continental usa. streetlight uses the cuebiq mobility index-continuous movement data calculated separately from the distance people travel from home-and a proprietary algorithm to produce a daily estimate of vehicle miles traveled, which is aggregated by county. we calculated a percentage of daily miles traveled, with the average of the first days of march used as the reference period. decreases in vehicle miles traveled indexed relatively more social distancing behavior. we used data from the county health rankings & roadmaps report to measure county-level indicators influenced by residents' health behavior: smoking, obesity, physical activity, flu vaccination, and mammography screenings. smoking measured the percentage of the adult population who smoke. obesity measured the percentage of adults with a body mass index > . we note that strictly speaking, obesity is a physiological risk marker for the development of chronic disease [ ] and reflects the cumulative effects of multiple health behaviors, including sedentary and physical activity time as well as diet. we include obesity here as a proxy for these behaviors and other lifestyle factors that give rise to adiposity. physical activity measured the percentage of adults over reporting no leisure time physical activity. flu vaccination rates measured the percentage of fee-for-service medicare enrollees that had an annual flu vaccine. mammography screening rate measured the percentage of female medicare enrollees aged - that received an annual mammography screening. these data were collected from the behavioral risk factor surveillance system, the cdc diabetes interactive atlas, and mapping medical disparities tool (for additional information on data sources and methodology, see https://www.countyhealthrankings.org/). all measures were recoded so that higher values reflected a greater percentage of health-protective behaviors. we also averaged health behavior indicators to form a single health behavior composite. the composite evidenced adequate internal reliability (α = . ). individual health behaviors were all significantly correlated with other health behaviors-effects ranged from small to large, ≤ rs ≤ . , all ps < . . the individual health behaviors were all highly correlated with the health behavior composite, rs ≥ . , ps < . (table ) . the county health rankings & roadmaps report included demographic and socioeconomic characteristics at the state and county level. variables used in the current study included county-level population, median household income, and rurality, as well as percentages of people who were women, non-hispanic white, older than , and had some college education. state-level population and rurality were also included. these data were collected from the american community survey, small area income and poverty estimates, and census population estimates. to test our hypotheses, we first examined the correlations between county-level indicators influenced by residents' health behaviors-smoking, obesity, physical activity, flu vaccination rate, mammography screening rate, and the overall health behavior composite-and changes in the two movement behavior outcomes. second, we used mixed effect linear models to test the association between these health behaviors and changes in movement. these models nested counties within states and controlled for a variety of state-and county-level demographic and socioeconomic characteristics. state factors were modeled as level- variables and county factors were modeled as level- variables in the mixed effect models. analyses were conducted in mplus version . [ ] . behavior during the pandemic? u.s. counties with lower rates of smoking and obesity, as well as higher rates of physical activity, flu vaccinations, and mammography screenings, had greater reductions in movement from the first week of march to the first week of april, both in the form of more people remaining within mile of home and people driving fewer vehicle miles per day ( table ). the bivariate associations among the conventional health behaviors were similar in magnitude to the associations between those health behaviors and changes in movement, which were moderate to large in size ( table ). the health behavior composite was also associated with changes in both percentage of people remaining within mile of home (r = . ) and vehicle miles people traveled per day (r = . ). figure illustrates changes in movement in counties categorized using the health behavior composite. when controlling for baseline levels of movement during the first week of march, the health behavior composite explained . % additional variance in the percentage of people remaining within mile of home and . % additional variance in the vehicle miles people traveled. we next tested whether health behavior predicted change in movement while accounting for state-and county-level demographic and socioeconomic characteristics in mixed linear models nesting counties within states. control variables at the state-level included population, rurality, and the presence of a state-wide stay-at-home order. control variables at the county-level included population, rurality, household income, education, gender, race/ ethnicity, and age. when accounting for these variables, the health behavior composite significantly predicted increases in people remaining within mile of home and decreases in the vehicle miles people traveled ( certain individual health behaviors may be more predictive of changes in movement behavior than others. to test this possibility, we specified mixed linear models for each of the individual health behaviors predicting change in movement behavior independently. obesity and physical activity were significantly associated with changes in both movement outcomes (table ). flu vaccination rate was significantly associated with decreases in vehicle miles driven, but not with the increase in people remaining within mile of home (table ). smoking and mammography screening rates were not significantly associated with either movement outcome (table ). these results suggest that obesity and physical activity were the strongest individual health behavior predictors of reduced movement outside the home. when examining the results of the health behavior composite mixed effect models (table ) , there were several associations of note at the county level of analysis. first, in terms of socioeconomic status, counties that were wealthier and more educated were more likely to reduce their movement. more urban counties were similarly more likely to reduce their movement outside the home. in terms of demographic factors, counties with a lower percentage of non-hispanic whites and a higher percentage of adults over the age of were more likely to reduce their movement outside the home, though the sizes of these effects were smaller than those for counties' socioeconomic characteristics. at the state-level of analysis, counties in states that enacted stay-at-home orders had a greater reduction in movement compared with counties without such an order. the current study examined whether county-level indicators of residents' health behavior were associated with social distancing in response to the covid- pandemic from march to april , . social distancing was assessed using objectively measured movement outside the home collected from gps-enabled devices and aggregated at the county level (n = , ) in the usa. people in counties with more health-protective behaviors prior to the pandemic reduced their movement to a greater degree during the pandemic than people in counties with fewer health-protective behaviors. the size of these effects were large-r = . for percentage of people remaining within mile of home, r = . for vehicle miles traveled, corresponding to roughly % of the variance in these outcomes. in terms of individual conventional health behaviors, rates of obesity and physical activity were particularly robust predictors of movement behavior. the significant associations among individual health behaviors matches well with prior evidence that such behaviors are correlated within individuals [ , ] , and extends these results to county-level associations. although there are calls to apply social and behavioral research [ ] to the current crisis on theoretical grounds [ , ] , few studies provide empirical evidence to buttress these claims. the findings reported here provide this evidence, which in turn supports application of the wealth of scientific knowledge regarding conventional health behaviors and health behavior change [ , , ] to promote social distancing. given the strong associations between conventional health behaviors and changes in movement behavior, a number of theoretical perspectives could have relevance to social distancing. for example, individual models of health behavior could inform our understanding of social distancing [ ] . the health belief model highlights how people's perception of threat related to a disease or condition-arising in part from the chance of getting a disease and severity of the disease-helps determine whether people engage in health-protective behavior [ ] . ecological models of behavior change [ , ] also present a number of principles that could be applied to social distaining behaviors. these models emphasize that people's behavior results from a combination of their individual decision-making and context of their family, neighborhood, and community. for example, perceptions of social norms play a powerful role in people's health behaviors, based in part on which behaviors they perceive as normative [ ] . the formal and informal groups people identify with (e.g., religious groups, political party identification, neighborhoods) likely impact their perception of social distancing and resulting behavioral choices. outlining each model of health behavior and how it might apply to social distancing from a theoretical perspective is beyond the scope of this study, but the existing literature presents ample opportunity to make use of accumulated empirical and theoretical knowledge to promote social distancing [ , ] during the current pandemic. health behaviors predicted changes in movement when accounting for a variety of demographic and socioeconomic covariates, though the sizes of these models nested counties within states. "march baseline" represents the average of the outcomes over the first week of march. rurality is coded as percent of the county or state that is rural. ethnicity is coded as percentage non-hispanic whites. education is coded as percent with some college education. gender is coded as percentage women. "stay-at-home order issued" assessed whether the state issued a stay-at-home order. *p ≤ . . **p ≤ . . effects were attenuated. this attenuation is unsurprising given the degree to which demographic and socioeconomic characteristics are associated with health behaviors. for example, socioeconomic disadvantage is associated with smoking, physical inactivity, and obesity [ ] . our results extend these findings to social distancing behavior, as assessed by reduced movement outside the home. socioeconomic disadvantage at the county-level, assessed by lower county-level household income and education levels, was associated with less of a reduction in movement outside the home. it is likely that the mechanisms proposed to explain socioeconomic disparities in health behaviors-such as differences in community opportunities or resources for health behavior change [ ] -are responsible for disparities in countylevel movement. for example, counties with greater socioeconomic disadvantage could have more residents with jobs in essential businesses (e.g., gas stations, grocery stores, healthcare), necessitating more movement outside the home. alternatively, residents in such counties could have smaller homes and less access to outdoor spaces, which would require more movement to engage in safe recreational activities. the current study did not, however, examine the causes of disparities in movement behavior. the large literature examining socioeconomic disadvantage and health behaviors [ ] would be useful in developing methods to reduce disparities during the current pandemic. effective interventions would be particularly important in socioeconomically disadvantaged counties, given associations of disadvantage with poorer health status and less access to healthcare [ ] . we found that county-level measures of health behaviors, demographics, and socioeconomic status were associated with changes in two movement behaviors. however, the extent to which these movement outcomes correspond to the constellation of all possible social distancing behaviors is unknown. for example, we do not know the number of close physical contacts people experienced based on their vehicle miles traveled. future study of the link between these outcomes and infection or mortality rates from covid- would provide evidence as to which measure of movement behavior is more valuable for informing public health practice during the current pandemic. regardless of which measure is ultimately more useful, the rapid speed at which these data become available-both cuebiq and streetlight data publish daily estimates with only a -day lag periodmakes these measures a promising ongoing method to predict areas that might be at risk of increased rates of infection. these data also have the advantage of avoiding issues with self-presentation bias that might affect selfreported adherence to social distancing behaviors. the current findings are relevant to public health policy at both a theoretical and practical level. the results provide evidence that interventions attempting to reduce people's movement to limit the transmission of the sars-cov- coronavirus, and during future pandemics, would benefit from drawing on evidence from past public health interventions targeting conventional health behaviors [ ] . social distancing is likely to remain the primary method of limiting infections to prevent hospitals from becoming overwhelmed until an effective vaccine is developed [ ] , and maintaining such behaviors will require a wide array of public health actions [ ] . behavioral medicine could play a key role in guiding public health policies for social distancing by promoting methods supported by decades of established theoretical and empirical research. for example, intervening on many levels-such as the individual, neighborhood, and societal level-would likely be more successful than attempts to address only a single level [ , ] . even once vaccines are developed, tested, and found to be effective, vaccinating the massive numbers needed to achieve herd immunity-likely in the hundreds of millions in the usa alone-will be a massive undertaking. these efforts could be informed by behavioral medicine approaches used to increase the rate of flu vaccinations [ ] , particularly among at-risk groups [ ] [ ] [ ] . both prior to a vaccine and once a vaccine is developed, our findings provide empirical evidence supporting the value in applying current evidence on health behavior change (e.g., the nih-funded science of behavior change) to the promotion of social distancing behaviors. at a practical level, this work suggests that counties in which people are at greater medical risk of hospitalization and death as a result of covid- are also the counties that reduced their movement outside the home the least in response to the pandemic. the health behaviors associated with less of a reduction in movement, particularly obesity and physical activity, are also associated with increased risk of chronic diseases, including lung diseases [ ] , diabetes [ ] , and cardiovascular diseases [ ] . these chronic conditions also predict poorer covid- prognosis [ ] . targeting people living in counties with unhealthier behaviors-particularly high levels of obesity and physical inactivity-using more intensive public health interventions could be a cost-effective method to promote social distancing and reduce morbidity and mortality from covid- . in addition, hospitals serving catchment areas that include counties with unhealthier behaviors-and likely more people with associated chronic diseases-might expect an outsized proportion of future hospitalizations due to covid- compared with counties with healthier behaviors. the results of this study should be understood in terms of its limitations. first, the study examined objectively measured movement but did not examine a number of other social distancing behaviors, such as the specific number of close-proximity contacts (e.g., < ft) people had outside their homes. it is possible for people to travel outside their home and maintain social distancing principles. although we expect other measures of social distancing to be highly correlated with movement outside the home, future work linking movement to viral transmission vectors would benefit our understanding of how movement is tied to risk of infection. second, the current study was correlational-these methods do not allow us to draw causal conclusions. the association between movement and conventional health behaviors could be explained by a number of alternative variables, such as local infection rates, people's perceptions of their at-risk status, or people's employment status. importantly, our results do not claim that health behaviors cause differences in movement, but instead tested the extent to which social distancing behaviors were associated with conventional health behaviors, with the goal of providing evidence as to the value in treating social distancing as a conventional health behavior. third, this study assessed county-level movement, not individual-level outcomes. the results need to be interpreted cautiously, lest we commit the ecological fallacy [ , ] and assume that what is observed at the county-level can be interpreted in individual-level terms. future studies would benefit from examining the extent to which conventional health behaviors are associated with social distancing behaviors, as well as how well movement behavior and other social distancing behaviors (e.g., staying > ft away from others, avoiding crowds) correlate within individuals. ongoing cohort studies that are initiating rapid assessment of social distancing behaviors [ ] and possess data on prior health behaviors would be an ideal source for such data. questions assessing other types of social distancing behaviors in addition to movement outside the home would enable future studies to test the extent to which these social distancing behaviors are associated among individuals. the current study examined the association between objectively measured movement outside the home and conventional health behavior indicators during the covid- pandemic. the results of this study provide empirical evidence that social distancing behavior-in the form of reduced movement outside the home-is associated with conventional health behaviors. public health efforts promoting social distancing would benefit from applying prior theoretical and empirical study of health behavior and health behavior change to social distancing behaviors during the current pandemic. supplementary material is available at annals of behavioral medicine online. clinical course and risk factors for mortality of adult inpatients with covid- in wuhan, china: a retrospective cohort study severe acute respiratory syndrome coronavirus (sars-cov- ) and corona virus disease- (covid- ): the epidemic and the challenges naming the coronavirus disease (covid- ) and the virus that causes it center for disease control and prevention. coronavirus disease our world in data targeted social distancing designs for pandemic influenza interventions to mitigate early spread of sars-cov- in singapore: a modelling study blavatnik school of government at the university of oxford coronavirus-government-response-tracker. accessibility verified estimating effects of physical distancing on the covid- pandemic using an urban mobility index multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science applying principles of behaviour change to reduce sars-cov- transmission who strategic and technical advisory group for infectious hazards. covid- : towards controlling of a pandemic estimating the burden of pandemic influenza a (h n ) in the united states using social and behavioural science to support covid- pandemic response health behavior and health education ecological models of health behavior the role of behavioral science theory in development and implementation of public health interventions patterns of health behavior in us adults clusters of lifestyle behaviors: results from the dutch smile study ecological models revisited: their uses and evolution in health promotion over two decades diagnosis of obesity and use of obesity biomarkers in science and clinical medicine mplus user's guide social norms and health behavior. handbook of behavioral medicine socioeconomic disparities in health behaviors socioeconomic disparities in health in the united states: what the patterns tell us coronavirus: the hammer and the dance interrupting transmission of covid- : lessons from containment efforts in singapore using behavioral insights to increase vaccination policy effectiveness systematic review of interventions to increase influenza vaccination rates of those years and older interventions to improve influenza and pneumococcal vaccination rates among community-dwelling adults: a systematic review and meta-analysis using behavior change frameworks to improve healthcare worker influenza vaccination rates: a systematic review the pathology of smokingrelated lung diseases sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis characteristics of and important lessons from the coronavirus disease (covid- ) outbreak in china ecological correlations and the behavior of individuals the disaggregation of within-person and between-person effects in longitudinal models of change ucl's longitudinal studies to survey thousands about impact of covid- the first author received support from national institute on aging training grant [grant t -ag ]. aggregated mobility data were provided by three companies: citymapper (via citymapper. com), cuebiq, and streetlight. cuebiq is a location intelligence and measurement platform. through its data for good program, cuebiq provides access to aggregated mobility data for academic research and humanitarian initiatives. these first-party data are collected from anonymized users who have opted-in to provide access to their location data anonymously, through a gdpr-compliant framework. it is then aggregated to the county level to provide insights on changes in human mobility over time. streetlight made data available for the purpose of nonprofit, public benefit research in response to the covid- pandemic. state-and county-level demographic, socioeconomic, and health behavior data were made available from the county health rankings & roadmaps (https:// www.countyhealthrankings.org/). the program is a collaboration between the robert wood johnson foundation and the university of wisconsin population health institute. key: cord- -d qmtysd authors: de azambuja, evandro; trapani, dario; loibl, sibylle; delaloge, suzette; senkus, elzbieta; criscitiello, carmen; poortman, philip; gnant, michael; di cosimo, serena; cortes, javier; cardoso, fatima; paluch-shimon, shani; curigliano, giuseppe title: esmo management and treatment adapted recommendations in the covid- era: breast cancer date: - - journal: esmo open doi: . /esmoopen- - sha: doc_id: cord_uid: d qmtysd the global preparedness and response to the rapid escalation to severe acute respiratory syndrome coronavirus (sars-cov)- -related disease (covid- ) to a pandemic proportion has demanded the formulation of a reliable, useful and evidence-based mechanism for health services prioritisation, to achieve the highest quality standards of care to all patients. the prioritisation of high value cancer interventions must be embedded in the agenda for the pandemic response, ensuring that no inconsistency or discrepancy emerge in the health planning processes. the aim of this work is to organise health interventions for breast cancer management and research in a tiered framework (high, medium, low value), formulating a scheme of prioritisation per clinical cogency and intrinsic value or magnitude of benefit. the public health tools and schemes for priority setting in oncology have been used as models, aspiring to capture clinical urgency, value in healthcare, community goals and fairness, while respecting the principles of benevolence, non-maleficence, autonomy and justice. we discuss the priority health interventions across the cancer continuum, giving a perspective on the role and meaning to maintain some services (undeferrable) while temporarily abrogate some others (deferrable). considerations for implementation and the essential link to pre-existing health services, especially primary healthcare, are addressed, outlining a framework for the development of effective and functional services, such as telemedicine. the discussion covers the theme of health systems strategising, and why oncology care, in particular breast cancer care, should be maintained in parallel to pandemic control measures, providing a pragmatic clinical model within the broader context of public healthcare schemes. the global preparedness and response to the rapid escalation to severe acute respiratory syndrome coronavirus (sars-cov)- -related disease to a pandemic proportion has demanded the formulation of a reliable, useful and evidence-based mechanism for health services prioritisation, to achieve the highest quality standards of care to all patients. the prioritisation of high value cancer interventions must be embedded in the agenda for the pandemic response, ensuring that no inconsistency or discrepancy emerge in the health planning processes. the aim of this work is to organise health interventions for breast cancer management and research in a tiered framework (high, medium, low value), formulating a scheme of prioritisation per clinical cogency and intrinsic value or magnitude of benefit. the public health tools and schemes for priority setting in oncology have been used as models, aspiring to capture clinical urgency, value in healthcare, community goals and fairness, while respecting the principles of benevolence, non-maleficence, autonomy and justice. we discuss the priority health interventions across the cancer continuum, giving a perspective on the role and meaning to maintain some services (undeferrable) while temporarily abrogate some others (deferrable). considerations for implementation and the essential link to pre-existing health services, especially primary healthcare, are addressed, outlining a framework for the development of effective and functional services, such as telemedicine. the discussion covers the theme of health systems strategising, and why oncology care, in particular breast cancer care, should be maintained in parallel to pandemic control measures, providing a pragmatic clinical model within the broader context of public healthcare schemes. the global preparedness and response to the rapid escalation of severe acute respiratory syndrome coronavirus (sars-cov)- -related disease at a pandemic proportion has demanded the prompt development of a reliable, applicable and evidenceinformed mechanism for the priority-setting of health services, to assure the attainment of the highest standards of quality care to all. while the response strategy to the global spread of covid- must be immediately integrated into public health policy, these actions require non-covid- health priorities to be urgently identified and defined to reshape health systems, which are struggling to meet the health demands in view of the rapid spread of the pandemic. in oncology, the definition of essential services must be developed within a value framework for organisational and clinical decision making-as the clinical response to covid- should never be developed a latere, but integrated in the multisectoral approach, to pursue overarching community goals, while preserving the perspectives of patient-centred care. no response from the oncology community should be disconnected from the broader healthcare priority setting mechanisms. a horizontal approach is envisioned, engaging with the continuum of care and embracing the primary healthcare sector to guide patients with cancer at home, including effectively developing telemedicine systems. globalisation has propelled the rapid spread of the disease, inundating healthcare systems, in particular, intensive healthcare capacities, thus necessitating the abrogation of some health services of deferrable priority as a key strategic approach. therefore, integrated healthcare planning is the bedrock of success in the preparation and response to covid- -including oncology. the need for value-based priority setting mechanisms has been envisioned by the global agencies for public health, especially when planning in health environments with impaired availability or accessibility to essential health resources, including epidemic outbreaks and disruptions of procurement chains and intermittent health service delivery-one of the global dividend of equitable quality care between well-resourced and de resource-constrained settings. in the era of covid- related constraints and the need to meet the goals of population health against threats that challenge the resilience of the health systems as we know them, the development of clinical guidelines must embrace an evidence-based mechanism to make choice, thus refusing the easy ways of perspectives or opinions approached per silos. the key to succeed in the management of cancer, when resources are limited or impaired by extraordinary events, is to define a methodology and create a value-enhanced framework with the most salient cancer interventions-attaining the principles of benevolence, non-maleficence, autonomy and justice. contemporary oncology research and care models are sophisticated and resource intensive in many countries. however, the necessary restrictions posed by the public health interventions in the pandemic control demand a practical framework for resource prioritisation, maintaining high standards of quality cancer care while protecting patients from health-related financial distress. patients with cancer have been suggested as a more fragile population, namely more vulnerable to sars-cov- infection, reporting poorer outcomes from covid- for multicomorbid and/or older patients-cancer history positioning as a possible independent prognostic risk factor. however, a general under-representation of patients with cancer in the mixed series published to date limits any articulated dissertation. in such an uncertain area of healthcare, the knowledge of protecting the vulnerable defines the needs for research implementation, addressing the spectrum of noncommunicable diseases including cancer, as mandated by who in strategising the response to covid- in the operational guidance for maintaining essential health services during an outbreak. the mandate is to ensure the essential services to all, prioritising per value. the trajectory of the present work aligns in parallel with the who indications to 'redirect chronic disease management to focus on maintaining supply chains for medications and needed supplies, with a reduction in provider encounters'approaching across the continuum of care and shaping a multidisciplinary dialogue across societies and diverse stakeholders. the present manuscript is the result of an international panel of expert health providers in the management of breast cancer and is proposed to guide healthcare professionals treating patients with breast cancer during the covid- pandemic. the expert consensus-based recommendations are not intended to replace the current guidelines but rather adapt breast cancer care during the covid- pandemic, using a value-based framework to set priorities. all the adaptations and prioritisations have been formulated by the experts via teleconferences and e-mails discussions. in the aim to provide a framework for the response of the medical community to covid- , the european society for medical oncology (esmo) has established a guidance for clinicians, defining three levels of priorities regarding medical interventions, namely: tier (high priority intervention), tier (intermediate priority) and tier (low priority)-informed by the ontario health cancer care ontario framework of resource-prioritisation and by the esmo magnitude of clinical benefit scale (mcbs), a public health tool intended to support the uptake of medical interventions in oncology. overall, the prioritisation has been developed to incorporate both the information on the value-based prioritisation and clinical cogency of the interventions (figure ). ► tier (high priority): patient's condition is immediately life-threatening, clinically unstable and/or the magnitude of benefit qualifies the intervention as high priority (eg, significant overall survival (os) gain and/or substantial improvement of the quality of life (qol)). ► tier (medium priority): patient's situation is noncritical but delay beyond - weeks could potentially impact overall outcome and/or the magnitude of benefit qualifies for intermediate priority. ► tier (low priority): patient's condition is stable enough allowing services to delay for the duration of the covid- pandemic and/or the intervention is non-priority based on the magnitude of benefit (eg, no survival gain with no change or reduced qol). of note, some interventions included in the tier and considered safely deferrable should be re-discussed after - weeks, to re-assess the priority and deliberate on the clinical cogency. the clinical guidance defined by esmo must be interpreted in the broader context of healthcare response to the pandemic, and always linked to the global norms of who, the lead public health agencies and health de technical governmental boards, for the definition of the strategies for the preparedness and response on populations-including the interventions to ensure the safest conditions for the health workforce, the proper provision of personal protective equipment, the testing strategy for healthcare personnel, patients and communities. inconsistencies of clinical guidelines developed outside the global strategy and not in coordination with the strategic population policies of pandemic control will inevitably harm communities, with the earliest impact being on the most vulnerable patients-patients with cancer being first among them. priorities for the management of breast cancer: reorganising the outpatient setting and sharing decisions meeting the community goals and perspectives of physical distancing and the overall public health measures for the mitigation of sars-cov- spread may necessitate a reinforcement and reorganisation of the outpatient setting. triaging patients for fever and covid- -related symptoms is mandatory and an entry checkpoint should be considered by all healthcare facilities. in the outpatient setting, postsurgical haematoma and infectious complications of surgical wounds may prompt ambulatory clinical interventions, like a drainage or an incision, to reduce the burden of serious, but preventable complications from cancer interventions, applying the priority criteria of clinical cogency. prioritisation is guided by magnitude of benefit, tumour biology and stage together with clinical scenarios. quality of care should remain unchanged for the prioritised interventions. for example, for the treatment planning of all patients with cancer, a multidisciplinary board discussion must be assured, as retaining a major prognostic significance: thus while the format may change (eg, videoconferencing), the principle of multidisciplinary care is non-negotiable (table ) . visits to hospital should be minimised and if necessary, all protective measures should be taken (eg, physical distancing recommendations and use of masks). also, there should be a triage for possible symptoms of covid- prior to enter into the hospital premises. the use of home-based services should be considered as much as possible while hospital procedures are still indicated for patients with cancer where delaying treatment may compromise cancer prognosis. for specific conditions resulting from treatment-related toxicities, such as febrile neutropenia with clinical and anamnestic adverse prognostic factors, a rapid clinical intervention can make a difference in the prognosis as well as optimise the treatment delivery plan, thus must be included in the priorities. accordingly, the safety monitoring of patients receiving oral treatments (eg, biological agents, endocrine agents and chemotherapeutics) should be organised through a quality system of telemedicine, assuring the requirements for a patient-centred connection with the oncologists and the cancer nurses. all the non-priority outpatient visits may be shifted to the telemedicine platform. the telemedicine delivery is best suited to non-urgent situations for established patients with no new complaints as well as survivorship and follow-up care of patients with cancer and of people referred to high-risk clinics (eg, brca carriers) for preventive interventions. in asymptomatic patients, follow-up exams can be delayed unless there are symptomatic clinically emergent conditions. the patient-centred model of care requires addressing all of a patients care needs and as such, psychosocial supports must be assured and may be converted to telemedicine or other web-based platforms. although telemedicine has been recognised as an efficient delivery platform for deferrable healthcare services, limiting factors must be considered. aspects of legal frameworks and data protection regulations, along with the management of the workforce for tele-health are of prominent interest. the consensus recognises the multiple legal and ethical issues, especially in the area of patient privacy and confidentiality-fostering the engagement with the competent vertices for healthcare professionals, healthcare facilities and academic institutions, communities, health managers and policy makers-to de mammography-based population screening and risk-adapted breast screening programmes for asymptomatic subjects (eg, mri or ultrasound). clinical evidence of locoregional relapse with surgical radical approach feasible (according to stage, histology and biological features of the disease) image-guided or clinically guided biopsy to ascertain a suspect of metastatic relapse. patients with abnormal findings at screening mammograms who can go to -month interval imaging (birads ). pathology assessment (histopathology or cytopathology) for abnormal mammograms or breast symptoms or a symptomatic metastatic relapse initial metastatic workup (according to stage and biological features) in patients with early stage invasive breast cancer. in patients with early stage breast cancer, followup imaging, restaging studies, echocardiograms, ecgs and bone density scans can be delayed if clinically asymptomatic. in patients with metastatic breast cancer, we recommend symptoms-oriented follow-up. imaging, restaging studies, echocardiograms and ecgs can be delayed or done at lengthened intervals. implement telemedicine follow-up. further diagnostic imaging for birads screening mammogram in asymptomatic subjects echocardiograms in patients with early stage invasive breast cancer requiring with indication to anthracycline-based or anti-her treatment. birads, breast imaging-reporting and data system. develop a socially accountable infrastructure of cancer service delivery. a public health approach is essentially endorsed, as the implementation of new service delivery models cannot be framed under a pure clinical indication but approached by multiple competent stakeholders. in principle, telemedicine is envisioned as part of the clinical service of the health personnel, thus accounted entirely in the clinical workload. eventually, although beyond the scope of the present work, sustainability, financing, reimbursability and health impact of telemedicine must be accountable, on the longer term, to inspire a durable set-up of innovative paradigms of healthcare via telehealth applications. from this angle, an assessment of the baseline capacity and interim registration of the efficiency of telemedicine should orient the entire process of capacity building and, if appropriate, prompt the establishment of the programmes. to date, the telemedicine model is interpreted across several applications and webbased platforms, within the national and local perimeters of legal frameworks-variable across the settings, and a definite optimum has not been defined in oncology, as data are still warranted. while the efficiency of the prescription of multiple treatment cycles (eg, several months of endocrine therapy and target agents for patients with metastatic breast cancer) to reduce the healthcare admissions is recognised, it may be critical to intersect the cancer institution activity in a service delivery model based on a primary healthcare approach-engaging with community-based healthcare providers, including general practitioners and nurses. overall, in the context of oncology care, telemedicine is indeed a mechanism to rethink the intersection of cancer care within the existing healthcare system. while providing clinical recommendations for telemedicine, all the key elements of the healthcare contexture are to be included in the discussion, to ensure that the clinical guidance is truly offering a valid alternative option for patients and not an ideal structure unfeasible on the pre-existing community services. of note, it is of utmost importance that all medical and strategic decisions regarding a patient's care programme are made with careful consideration by a multidisciplinary team and shared with the patient. an informed consent process needs to be performed ensuring that the patient fully understand the risks and benefits she/he can expect from any medical intervention in the context of the current public health crisis, with all its limitations. priorities for the radiological and pathological diagnosis of breast cancer understanding the implications of the delay in diagnosis and access to treatment of breast cancer cannot be entirely captured unless contextualised to the biology of the cancer and patterns of clinical presentation, for example, the stage and the setting of care. all patients presenting with a new breast lump with high suspicion of malignancy or who have already undergone a screening procedure with an imaging finding highly suspicious for malignancy (eg, birads at mammography) should be promptly referred for tissue diagnosis and imaging and pathology are to be designated as high priority (table ) . de similarly, patients experiencing locoregional disease recurrence of breast cancer can still pursue a radical intention for the treatment-with a combination of locoregional treatments, either surgery and/or radiation therapy, and complemented with risk-reducing medical therapies: targeted, endocrine or chemotherapy. [ ] [ ] [ ] in this setting, it becomes essential to share the clinical decision, informed by the primary intention of the approach. although often complex across a spectrum of clinical presentations, some disease recurrence patterns are more prone to radical approaches and, long-lasting disease-free intervals can be expected. thus, based on clinical and pathological criteria, priority must be based on the intention of the care to identify the undeferrable cases, always in a multidisciplinary assessment. overall, histopathology diagnosis can have an immediate impact and sometimes cannot be deferred to complete the differential diagnosis. for patients with symptomatic metastatic relapse, whenever the provision of a treatment can be life-saving and/or significantly modify the quality of life, a histopathology diagnosis will be included in the set of undeferrable health services. besides the primary treatment intentions, the safe delivery and safety monitoring of treatments may require specific imaging techniques. commonly, patients under treatment with anthracyclines or anti-her agents require a regular assessment of cardiac function, prompting treatment interruptions, dose-reductions or cardio-oncology interventions, where indicated. similarly, the ecg assessment for potentially arrhythmogenic changes, including the qt tract prolongation, should be considered in selected patients receiving some biological agents or carrying specific comorbidities. overall, the cardio-oncology consultation could be reshaped in a riskadapted scheme, adapting the monitoring intensity to the baseline risk of cardiac adverse events and the treatments received. during the pandemic outbreak, mammography-based screening for breast cancer in asymptomatic women should be temporarily abrogated, as the risk-benefit ratio (risk of infection related to healthcare admissions for second-level procedures vs lives saved by screening) is not predicted to be high during the pandemic and appointments may be postponed by a few weeks or months without disproportionate predicted harms. similarly, imaging for follow-up of patients with early breast cancer and metastatic patients may be delayed if necessary, with tailoring of radiological assessments per symptoms or other suspicion of progression, as clinically assessed-while still preferring telemedicine for non-priority complains and interventions. priorities for breast surgical oncology cancer surgery is one of the cancer interventions bringing the greatest benefits for patients with cancer, principally in the curative setting, resulting in gains in cancer survival. the priority-setting framework of breast cancer surgery aims to understand how reasonably and for how long cancer surgery can be delayed, assuring the attainment of the highest standards for quality care delivery. once again, the question must take into account cancer biology, clinical presentation pattern, patients' conditions and preference (table ) . the clinical cogency for intervention is dictated by the risk for serious complications or irreversible health conditions, like for postsurgical breast cancer complications. where relatively simple surgical interventions can determine a change in the natural process of a potentially adverse pathological condition at rapid evolution, it represents a surgical priority. this also includes surgery complications demanding haemostatic procedures, incision, drainage or packing material insertion and certain wound dressing. however, relatively more complex procedures can sometimes still retain a priority, when inaction is associated with potentially fatal outcomes (eg, for the delay of adjuvant treatments). several respected professional societies have proposed classifications of urgency/ benefit/postponability. based on the magnitude of benefit criteria, patients completing neoadjuvant chemotherapy-based treatments or, less commonly, progressing during such treatments, should receive curative surgery with no postponement. in situations in which this is absolutely impossible in terms of crisis healthcare resources, adding another cycle of neoadjuvant therapy in patients responding well to therapy may 'protect' the patient from the postponement of surgery. primary surgery of low-risk early breast cancer can safely be postponed up to weeks, based on experts' opinion, although no firm data exist, unless very aggressive tumour biology is present. in latter situations, neoadjuvant treatment approaches may be considered anyway. for luminal-like breast cancers, using appropriate preoperative endocrine treatment might be an option for avoiding harm due to the delay of surgery in selected cases. the psychological strain for patients who experience delays of their surgical procedures must not be underestimated, and appropriate psychological support offered. surgery for in situ ductal carcinomas could be transiently deferred in some cases, and the use of endocrine therapy if hormone receptor positive may be considered. reconstructive procedures can/should be postponed, also because their perioperative morbidity risk is higher than that of standard breast surgery. as discussed above, patients experiencing locoregional relapse should be discussed in a multidisciplinary setting to weigh the potential benefits of offering an immediate radical surgical excision with subsequent durable survival gain versus postponing surgery after a primary systemic treatment. as for all the other clinical presentations, the discussion about surgical indications must be individualised. of note, all decisions must be shared with the patients, assessing the preference and expectations while informing on the de threats and advantages of the adapted treatment plans in the context of the covid- crisis. priorities for breast radiation oncology the indications for radiation therapy in breast oncology are wide, and must be interpreted in the multidisciplinary care settings. according to clinical prioritisation, immediate radiation therapy should be initiated, in accordance with current clinical practice, in patients with acute spinal cord compression, symptomatic brain metastases not improving with steroidal medication and any urgent irradiation with an expected impact in survival or a modifying effect on the risk of disabling sequelae and/or quality of life ( breast mass-related symptoms for fungating or bleeding neoplasia can usually be obtained with supportive care interventions, including advanced wound dressings, there may exist a need to provide surgery or radiation therapy for haemostasis or to alleviate pain due to inoperable breast masses for improving the quality of life for patients with advanced disease. the optimisation of locoregional control and the improvement of survival define the priority of the interventions in radiation therapy. thus, post-operative radiation therapy for high-risk patients (eg, inflammatory breast cancer, node-positive or high-risk biology) should be scheduled as high priority, respecting the highest standards of quality for radiation therapy when proposing alternative (shorter) radiation regimens. most patients are eligible for short-course treatments using hypofractionated schedules, being the treatment of choice. accelerated partial breast irradiation should be proposed for low-risk patients, when indicated and technically feasible, given available technology and the capacity of the centres. also for this, shorter treatment courses should be favoured, including single dose intra-operative electron radiation therapy or up to fractions of preferably external beam radiation therapy and not brachytherapy as this implicates a second intervention and more intense hospital visits. where the expected clinical benefit of irradiation is very low, as in the older population with lowrisk breast cancer under adjuvant endocrine therapy, deferral is possible or omission could even be considered in some circumstances. the aim is to maintain a balance between respecting covid- restrictive measures such as limiting number of contacts and physical distance, while at the same time preventing jeopardising the outcomes of cancer interventions, considering that radiation therapy usually requires a sometimes long series of treatments with repeated admissions to the institutions. this should be an additional argument for applying the abundance of evidence in favour of the use of hypofractionation in clinical practice. priorities for breast medical oncology in the early setting of care the role of presurgical, perisurgical and postsurgical systemic therapies has evolved to become the backbone of care in breast oncology, and over the last decade a paradigm shift in systemic care has occurred, with the tailoring of type and timing of care to tumour subtypes. the delivery of systemic treatments usually demands a resource-intense effort of the health institutions, built around the patient, with optimal safety conditionsstating that the quality of medical oncology must attain the highest standards, when priority interventions are established (table ) . during pandemics, the disruption of the procurement chain for medicines and the changed contexts of drug selection can have an impact on the availability and accessibility of medicines, including irregular provision or shortage of medicines for the supportive care. optimising the medical oncology service during covid- means assuring the assignment of the treatments at the highest benefit to the eligible population, in the safest conditions and guaranteeing punctual monitoring mechanisms for the adverse effects, implemented by telemedicine systems and engaging with primary healthcare sectors-an effort of one health system working in synchrony. decisions at national and institutional level can be readily informed by public health tools of selection and prioritisation of the medical interventions, including the esmo mcbs. according to the mcbs, the priority interventions in the curative setting are scored a, on a scale from a to c, from high to low priority, respectively. while the score has been applied to a several novel compounds for breast cancer treatment, mostly in the advanced setting, less scoring has been performed in the early breast cancer setting, particularly with chemotherapy regimens, and this should be considered when balancing risk and benefits. patients with the highest risk breast cancers are to be prioritised for systemic treatments (ie, either triplenegative or her -positive early breast cancer). overall, adjuvant endocrine treatments are not expected to be substantially changed, not impacting significantly on immune functions, while the monitoring for side effects and treatment compliance could be readily performed via telemedicine. of note, in case of sars-cov- infection in a patient with breast cancer taking tamoxifen, the hormone therapy should be suspended and preventive measures against thrombosis proposed, given the high risk of thromboembolic events in patients with covid- with severe disease, and the well-known increased thromboembolic risk associated with tamoxifen. for some patients, a neoadjuvant endocrine approach could be considered, according to the current clinical recommendations, and possibly to delay the time to surgery in selected clinical presentations. this group encompasses patients with postmenopausal stage i cancers, low-grade to intermediate-grade tumours and lobular breast histology variants, deferring the surgery up to - months, as indicated in existing guidelines. aromatase inhibitors (ai) should be preferred. while for postmenopausal women neoadjuvant endocrine therapy is an established approach, this is not so for premenopausal women but may be considered on a case-bycase basis under these extenuating circumstances. all premenopausal women receiving an ai should receive lhrh (luteinizing hormone-releasing hormone) analogue. monthly injections should be preferred but in some cases (particularly women in their mid-late s), one may discuss -monthly formulation of lhrh analogue, in order to reduce patient visits. overall, homebased monthly administrations would be the preferred choice. the possibility to deliver treatments at home, including some antineoplastic agents (eg, subcutaneous trastuzumab, lhrh agonists) is framed in the national de -continuation of standard adjuvant endocrine therapy in premenopausal and postmenopausal setting. use telemedicine to manage potential toxicity reported by patients continuation of treatment in the context of a clinical trial, provided patient benefits overweight risks, with possible adaptation of procedures without affecting patient safety and study conduct. regulatory agencies and sponsors may provide guidance on rules on study conduct during the pandemics -and regional competencies in the matter of healthcare organisation and regulations on medicines-conditioning the grades of operational flexibilities for the treatment delivery at the time of covid- . however, any initiative for home-based care should be built under the covid- agenda, to ensure consistency with the physical distancing measures and protection of both the patients and the workforce. moreover, for selected her -positive breast cancer, low-risk or elderly patients with cardiovascular or other comorbidities adjuvant trastuzumab may reasonably be discontinued after months instead of months of treatment, according to clinical guidelines. ongoing treatments should be fully completed, as any compromise in dose density and intensity may adversely impact prognosis. for triple-negative and her -positive patients with breast cancer treated with neoadjuvant therapies and not reaching a pathological complete response, postneoadjuvant systemic treatments are highly recommended as they provide durable disease control and improved survival. the selection of the most appropriate schedules of chemotherapy will make considerations of at least three factors: the number of monthly admissions to the institutions, preferring -weekly or -weekly schedules; the need to escalate immunosuppressive supportive medications (eg, steroids for premedication); the informed patient's preference. in the midst of uncertainties of the impact of immune-suppressive agents or steroids used for premedication at non-immunosuppressive doses on the risk of sars-cov- infection and covid- outcome, the use of these agents should be carefully evaluated. the use of granulocyte growth factors may be considered to minimise neutropenia. priorities for breast medical oncology in the advanced and metastatic setting of care the decision making for priority positioning in the metastatic setting is more complicated. in the clinical landscape of effective treatments that impact on the quality of life and the survival, the best treatment approaches should be part of the health priorities (table ) . the health cogency criterion demands prompt cancer treatments in patients where a delay can result in fatal outcomes. for example, patients experiencing cancerrelated treatment organ dysfunctions or at increased risk of it, namely patients in visceral crisis, should be prioritised for the start of antineoplastic treatments. consider, discussing case-bycase, inclusion in a clinical trial, provided patient benefits overweight risks, with possible adaptation of procedures without affecting patient safety and study conduct. -mtor, mammalian target of rapamycin; pd-l , programmed death-ligand ; pik ca, phosphatidylinositol- , -bisphosphate -kinase catalytic subunit alpha; tnbc, triple-negative breast cancer. according to the mcbs, the priority interventions in the advanced setting are scored , or , in a descending scale for value, from to . for such, the magnitude of benefit and the expected treatment benefits should guide the clinical indications. early line chemotherapy, endocrine therapy and targeted agents with higher mcbs score are of choice, and should be delivered in the eligible population-for example, in the prescription of the double anti-her blockade plus chemotherapy as first line for patients with her -positive disease, where affordably accessible (mcbs score ). the use of immunotherapy (eg, atezolizumab) and cdk / inhibitors and endocrine therapy (mcbs scores of - ), should be considered after a case-by-case discussion taking into account baseline risk factors of the patient and their functional status, along with considerations on the disease pattern of spread and biology-to ensure a critical decision making by tailoring for the single patient, in accordance with local practice and resource availability. in the midst of uncertainty related to some immune-modulating agents with limited value in cancer treatment, avoiding or delaying the addition of mtor inhibitors to endocrine therapy could be prudent, especially in multicomorbid older patients (mcbs score for everolimus: ). this means that the contingency plan during the pandemic could result in the temporary withdrawal of some interventions, or predefined safe delays. the use of oral bisphosphonate or subcutaneous denosumab can be considered in some cases, as to the choice of longer intervals for intravenous bisphosphonates, for example, every months. similarly, in late treatment lines, patients with poorer prognosis and impaired functional status could be considered for a best supportive care (bsc) approach and/or drug holiday periods-with consideration given for the benefits in terms of quality of life, while attaining to the highest standards of care: an early start of home-based supportive care plan and the judicious referral of some patients to bsc is a priority, overall, when the available therapies are known to provide only a narrow benefit and they may incur on the patient excessive of toxicity. treatment de-escalation and/or maintenance with oral agents may be considered, although largely based on experts' opinions. the continuation of treatment in the context of a clinical trial is valuable for cancer clinical research, provided patient benefits outweigh risks, with possible adaptation of trial procedures without affecting patient safety and study conduct. to date, the social distancing measures have partially frozen the preclinical laboratory-based research in many countries, in response to the urgent need to prioritise the services with an immediate role in covid- response and to serve community needs. overall, the national and regional regulatory agencies have formulated guidance for the management of patients enrolled in clinical trials, de providing recommendations on the exploitation of the study procedures and the safe delivery of the study medications, including concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations. in such a context, protocol deviations are expected and some are justified, when not exposing patients to safety issues and facilitating procedural barriers or bureaucratic aspects of study procedures: a real moment to re-think the clinical trial conductions tout court. for instance, in europe the recommendations of the european medicines agency can be found at: https://www. ema. europa. eu/ en/ news/ guidance-sponsors-how-manage-clinical-trialsduring-covid- -pandemic in the usa, the food and drug administration also released guidance on clinical research and covid- (https://www. fda. gov/ media/ / download). while avoiding a total distraction of the cancer research community from the goals and research questions and slowing the progress in cancer care-research questions of immediate clinical interest for cancer and covid- have been implemented, bridging the need to provide responses to patients with cancer and the advancement of knowledge. several ongoing trials are addressing the safety and trying to dissect the interplay of anticancer and antiviral immune responses. generating quality evidence is now the real priority, to enhance the clinical decision-making: the observational series of the first waves are now expected to leave room for controlled studies, mechanistic explanations and translational experiences, ensuring the best research at the service of the cancer and pandemic response. there is an ongoing list of clinical trials testing different strategies in patients with covid- and they can be found at http://www. redo-project. org/ covid- _ db-summaries/ for cancer care, covid- is presenting a challenging period in medicine, demanding a re-focus on the value and priorities of health interventions, including the reshaping of cancer care-catalysing a review of valuebased and patient-centred decision making. setting priorities based on the intrinsic value of the interventions about patients' outcomes and ensuring simultaneously population and societal benefits is the perspective in which the response to covid- has been designed. the priority-setting mechanism that is envisioned aligns with the global, regional and national standards proposed in several work streams, including the development and implementation of the mcbs scale, which is based on patient-related end points and aimed to provide a statement and guidance on priority setting, to support and enable decision making when resources need to be rationed and cautiously allocated. who has defined differentiated preparedness and response plans, according to the disease spread in single countries, providing global guidance and guidance for local action. this means that the degree of sars-cov- spread in a country dictates the type and intensity of the public health interventions and should also orient the selection and prioritisation of the health interventions in oncology-with a tiered approach. the perimeters and limits of this work should be interpreted and adapted within the national and regional dispositions in terms of the ability towards health system reorganisation and reshaping of the existing model. while some countries have interpreted a segregation model, and suggestions from who seems to propend more for the identification of a covid- health pathway for prompt referral, policies can vary across countries, related to the stage of the pandemic as well as the health sector specificities. in such a complex setting, this clinical guidance for breast cancer management is intended to orient and not decree local guidelines, and guide the development of action plans to maintain a quality cancer service, setting a minimal array of required interventions. useful information can be found at https://www. esmo. org/ guidelines/ cancer-patient-management-during-thecovid- -pandemic/ breast-cancer-in-the-covid- -era contributors gc developed the first outline and coordinated the authors' contributions, engaged for competencies and expertise in the management of breast cancer, development of adapted guidelines in special circumstances and its methodology. gc and dt formulated the first draft to organise the authors' work, and with eda developed a draft zero. all the authors were involved in writing and, when the first draft had been developed, all the authors refined the contents with feedbacks and comments, incorporated by gc, eda and dt. all the authors approved the final draft before the submission. while the authors are affiliated to different institutions for cancer research and care, the perspectives expressed in the present paper should not be intended to mirror the societal and institutional positions. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. seattle genetics, teva. eda honoraria and/or advisory board from roche/gne, novartis, seagen and zodiac; travel grants from roche/gne and gsk/novartis; research grant to the institution from roche/ gne, astrazeneca, gsk/novartis and servier. cc 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randomised controlled trial coronavirus is proving we need more resilient supply chains. harvard business review anticoagulant treatment is associated with decreased mortality in severe coronavirus disease patients with coagulopathy [published online early breast cancer: esmo clinical practice guidelines for diagnosis belis: safety and tolerability of at home administration of trastuzumab (herceptin) subcutaneous for the treatment of patients with her -positive early breast cancer versus months of adjuvant trastuzumab for her -positive early breast cancer (persephone): -year disease-free survival results of a randomised phase noninferiority trial determinants of last-line treatment in metastatic breast cancer conducting phase cancer clinical trials during the severe acute respiratory syndrome coronavirus (sars-cov- )-related disease pandemic key: cord- - fl gwp authors: ouassou, hayat; kharchoufa, loubna; bouhrim, mohamed; daoudi, nour elhouda; imtara, hamada; bencheikh, noureddine; elbouzidi, amine; bnouham, mohamed title: the pathogenesis of coronavirus disease (covid- ): evaluation and prevention date: - - journal: j immunol res doi: . / / sha: doc_id: cord_uid: fl gwp coronavirus disease (covid- ) has become a major health problem causing severe acute respiratory illness in humans. it has spread rapidly around the globe since its first identification in wuhan, china, in december . the causative virus is called severe acute respiratory syndrome coronavirus (sars-cov- ), and the world health organization (who) named the new epidemic disease coronavirus disease (covid- ). the incidence of covid- continues to increase with more than three million confirmed cases and over , deaths worldwide. there is currently no specific treatment or vaccine against covid- . therefore, in the absence of pharmaceutical interventions, the implementation of precautions and hygienic measures will be essential to control and to minimize human transmission of the virus. in this review, we highlight the epidemiology, transmission, symptoms, and treatment of this disease, as well as future strategies to manage the spread of this fatal coronavirus. coronaviruses belong to the coronaviridae family in the nidovirales order. corona represents crown-like spikes on the outer surface of the virus; thus, it was named coronavirus. coronaviruses are minute in size ( - nm in diameter) and contain a single-stranded rna as nucleic material, with a size ranging from to kilobases (kb) in length. the subgroups of the coronavirus family are alpha (α), beta (β), gamma (γ), and delta (δ) [ ] . several coronaviruses can infect humans, like the globally endemic human coronaviruses hcov- e, hcov-nl , hcov-hku , and hcov-oc that tend to cause mild respiratory disease, and the zoonotic middle east respiratory syndrome coronavirus (mers-cov) and severe acute respiratory syndrome coronavirus (sars-cov) that have a higher case fatality rate [ ] . in late december , a cluster of patients was admitted to hospitals with an initial diagnosis of pneumonia of an unknown etiology. these patients were epidemiologically linked to a seafood and wet animal wholesale market in wuhan, hubei province, china [ , ] . the pathogen has been identified as a novel coronavirus. initially tentatively named novel coronavirus ( -ncov), the virus has now been named sars-cov- by the international committee of taxonomy of viruses (ictv) [ ] . this virus can cause the disease named coronavirus disease (covid- ) [ ] . the sars-cov- belongs to the same coronavirus group (betacoronavirus) as sars and mers viruses that caused two of the more severe epidemics in recent years. as with sars and mers, this new coronavirus, -ncov, is believed to be of zoonotic origin, but may also be transmitted through the respiratory tract, by direct contact, and possibly via patients excreta which may contain the living virus [ ] . since the emergence of the novel coronavirus ( -ncov) infection in wuhan, china, it has rapidly spread across china and many other countries [ ] . the outbreak of covid- has affected more than three million patients in countries, areas, or territories with a mortality rate of . % and has become a major global health concern [ ] . based on the evidence of a rapidly increasing incidence of infections and the possibility of transmission by asymptomatic carriers [ , ] , sars-cov- can be transmitted effectively among humans and exhibits high potential for a pandemic [ ] [ ] [ ] . to date, the disease has spread worldwide and become a serious infectious disease affecting human health worldwide [ ] . in the absence of specific therapeutic drugs or vaccines for novel coronavirus disease , it is essential to detect the diseases at an early stage and immediately isolate the infected person from the healthy population. in this paper, we attempt to review and document the current data related to corona virus disease (covid- ) including etiology, epidemiology, clinical characteristics, and measures of treatment of covid- , with a special focus on infection control and prevention. in december , wuhan city, province of china, became the center of an outbreak of novel contagious coronavirus disease (covid- ) of unknown etiology [ , ] . efforts are underway to continue to better understand more about transmissibility, severity, and other features associated with covid- [ ] . it appears that an infected animal may have first transmitted the virus to humans at a seafood market [ , ] . soon, a secondary source of infection was found to be human-to-human transmission of the covid- virus [ ] . it became clear that the covid- infection occurs among close contacts and exposure to the virus [ ] . recent studies showed that people aged ≥ years and the population with poor immune function such as diabetes, cardiovascular disease, chronic respiratory disease, cancer, renal, and hepatic dysfunction are at higher risk for severe covid- than children who might be less likely to become infected or, if so, may show milder symptoms or even asymptomatic infection [ ] . coronavirus disease (covid- ) is spreading rapidly across china and is being exported to a growing number of countries, some of which have seen onward transmission. according to the world health organization (who), covid- continues to emerge and represents a serious problem to public health. on may of march , more than three million confirmed cases of covid- reported by the world health organization. of these, more than have been fatal. about , cases were confirmed in china, and deaths were confirmed ( figure ) [ ] . the growing global tally includes spikes in korea, iran, italy, spain, france, and germany. the virus is also continuing to spread to african countries including algeria, south africa, senegal, burkina faso, cameroon, nigeria, and côte d'ivoire. in addition to the confirmed case, moroccan's health ministry says that morocco has more than confirmed cases of the coronavirus. the sars-cov- was found to be a positive-stranded rna virus belonging to the genus betacoronavirus with a crown due to the presence of spike glycoproteins on the envelope ( figure ) [ ] . other than sars-cov- , there are six types as humans coronaviruses have been identified, namely, hcov- e, hcov-oc , sars-cov, hcov-nl , hcov-hku , and mers-cov [ ] . phylogenetic analysis revealed that the sars-cov- is closely related, with - % similarity, to two bat-derived severe acute respiratory syndrome-(sars-) like coronaviruses, bat-sl-covzc (accession no. mg . ), and bat-sl-covzxc (accession no. mg . ), but it is more distant from sars-cov, with about % similarity, and mers-cov, with about % similarity [ ] [ ] [ ] . the sars-cov- has an envelope; its particles are round or elliptic and often polymorphic form, and a diameter of nm to nm [ ] . additional studies based on the genetic sequence identity and the phylogenetic reports confirmed that covid- is different from sars-cov, and it can thus be considered as a new betacoronavirus that infects humans [ ] . the source of the -ncov is still unknown. however, the growing outbreak has been linked to the huanan south china seafood market [ ] . scientists are trying to find the animal host of this novel coronavirus in hopes of eradicating the spread, but so far, no one is certain. most sources agree that the possible host of the -ncov is bats, pangolins, or seafood [ , , ] . the task at hand is to find the intermediate host that is responsible for transmitting the coronavirus to humans. it is important to determine the source of the virus, to help the discovery of the zoonotic transmission patterns [ ] . sars-cov- presents a high transmissibility and pathogenicity [ ] . it could be transmitted from human to human by droplets and contact [ ] . several reports have suggested that symptomatic people are the most frequent source of covid- spread. it primarily spreads between people through respiratory droplets by coughing or sneezing from an infected individual [ ] . moreover, there are suggestions that individuals who remain asymptomatic could transmit the virus. further, studies are needed to clarify and understand the mechanisms of transmission, the incubation period, and the duration of infectivity of this virus. in patients with coronavirus disease (covid- ), the most common clinical symptoms are fever and cough, shortness of breath, and other breathing difficulties in addition to other nonspecific symptoms, including headache, dyspnea, fatigue, and muscle pain [ , ] . moreover, some patients also report digestive symptoms such as diarrhea and vomiting [ , ] . covid- was similar to sars and mers in some clinical manifestations [ ] . fever occurred in - % of patients with sars or mers, compared to . % of patients with covid- [ , , ] . . % of patients had no fever at admission, suggesting that the absence of fever could not rule out the possibility of covid- [ ] . although patients initially have fever with or without respiratory symptoms, various degrees of lung abnormalities develop later in all patients, and these can be seen on chest ct (ct) [ , ] . although diarrhea is present in approximately - % of patients infected with mers-cov or sars-cov, intestinal symptoms have rarely been reported in patients with covid- [ ] . patients receive chest ct scans that provide reliable data on the dynamic x-ray pattern. typical mild covid- pneumonia begins primarily with small, subpleural, unilateral, or bilateral frosted glass opacities in the lower lobes, which then develop into a crazy-paving pattern and subsequent consolidation. after more than two weeks, the lesions are gradually absorbed with residual frosted glass opacities and subpleural parenchymal bands. in these patients who have recovered from covid- pneumonia [ ] . at admission, the majority of patients had lymphopenia and platelet abnormalities, neutrophils, aspartate aminotransferase (ast), aspartate aminotransferase (ast), lactate dehydrogenase (ldh), and inflammatory biomarkers. according to the results of the ct or x-ray, the patients had bilateral pneumonia and pleural effusion that occurred in . % of the patients. compared to patients in general, refractory patients had a higher level of neutrophils, ast, ldh, and reactive protein c and a lower level of platelets and albumin. in addition, refractory patients had a higher incidence of bilateral pneumonia and pleural effusion [ ] . in general, hospitalized patients are classified in two categories, the general covid- which has been defined according to the following criteria: obvious relief of respiratory symptoms (for example, cough, chest distress, and shortness of breath) after treatment, maintaining normal body temperature for more than three days without the use of corticosteroids or antipyretics, improving radiological abnormalities in the chest scanner or x-rays after treatment, a hospital stay of less than days. otherwise, it was classified as covid- refractory. in the admission severity assessment, a serious illness was defined if it met at least one of the following: respiratory rate /min, pulse oximeter oxygen saturation (spo ) % at rest, and partial arterial oxygen pressure (pao ) at the inspired oxygen fraction (fio ) mmhg [ ] . after the diagnosis of sars-cov infection was made, the prevention and quarantine are considered as the most way to stop the fast spreading of the virus, because there is no effective vaccine, drugs, or antiviral to prevent and treat this disease despite the great efforts made by the scientists and researchers around the world to develop vaccines and treatments of coronavirus. furthermore, several strategies were carried out to help patients with covid- as oxygen therapy (major treatment intervention), antivirals (lopinavir, ritonavir, ribavirin, favipiravir (t- ), remdesivir, oseltamivir, chloroquine, and interferon) [ , , ] . most importantly, unselective or inappropriate administration of antibiotics should be avoided. moreover, corticosteroids treatment should not be given for the treatment of sars-cov [ ] . convalescent plasma can journal of immunology research be used to help people recover from viral infection without the occurrence of severe adverse events [ ] . among the difficulties that avoid finding the treatment for covid- is that the spike protein of the virus interacts with the host cell receptor including grp (glucose regulating protein ). consequently, the inhibition of this interaction would probably decrease the rate of the infection [ ] . lopinavir (protease inhibitor used to treat hiv) or lopinavir/ritonavir has shown in vitro anti-coronavirus activity [ ] . in addition, the utilization of lopinavir/ritonavir showed a reduction of viral loads and it was found that it is able to improve virus symptoms during the treatment period [ ] . other reported antiviral treatments form human pathogenic covs include neuraminidase inhibitors like oral oseltamivir has been used in china hospitals for covid- cases [ ] . no study has demonstrated the effectiveness of oseltamivir in the treatment of sars-cov- [ ] . in wuhan, on february , a clinical trial was initiated of remdesivir (newly discovered antiviral drug) on sars-cov- . this compound showed an inhibition of the replication of sars-cov and mers-cov in tissue cultures and efficacy in animal models [ ] . however, given the related issues of security, safety, and efficacy, it is necessary to take some time to develop the vaccine and the antiviral drugs [ ] . for a thousand years, traditional chinese medicine has gained an important experience in the infection healing. currently, this kind of medicine has provided significant therapies for many current diseases as a h n influenza, a h n influenza, ebola virus, and sars-cov [ ] [ ] [ ] . consequently, it can be also developed and applied in the treatment of covid- . in fact, the decoction combination of ma xing gan shi (combination includes ephedrae herba, armeniacae semen amarum, glycyrrhizae radix and rhizoma, and gypsum fibrosum) with da yuan yin that includes arecae semen, magnoliae officinalis cortex, tsaoko fructus, anemarrhenae rhizoma, dioscoreae rhizoma, scutellariae radix, glycyrrhizae radix, and rhizoma had showed in an important and a significant impact on sars. the state administration of traditional chinese medicine advised on february , the utilization of qing fei pai du decoction that includes ephedrae herba, gypsum fibrosum, pinelliae rhizoma, aurantii fructus immaturus, and zingiberis rhizoma recen. this decoction has been shown to be % effective in the treatment of sars-cov- [ , ] actually, there is no specific treatment or vaccine of covid- ; all of the drug options come from experience treating influenza, hiv, sars, or mers. at present, current efforts are focused on developing vaccines or specific antiviral drugs for covid- . according to what was published by the world health organization and a number of international health institutes, there are many restrictions that must be followed, either on a personal level or on the environmental level, including early recognition by the patients; carrying out additional precautions for persons suspected of infection, as well as for people who had contact with patients before their patients were revealed; applying standard precautions for all patients and imposing administrative measures from various authorities, such as the environment and health authorities [ , ] . in the current situation and to limit the spread of the covid- virus, all countries should publish an awareness declaration of the symptoms of infection in all cities, especially in remote areas. also, publish the easiest and fastest way for the methods that every patient should follow in the event of a patient. in addition, encourage hcws to have a high level of clinical suspicion [ , ] . the who confirmed that the rational, correct, and consistent use of personal protective equipment (ppe) also helps reduce the spread of pathogens. ppe effectiveness depends strongly on adequate and regular supplies, adequate staff training, appropriate hand hygiene, and appropriate human behaviour [ , , ] . at the level of additional precautions for patients, patients should be isolated in private quarantine rooms; everyone who contact with the patients, whether family, friends, or visitors, should be placed in a quarantine and a distance for contacting between them should be established [ ] ; the patients should cover their mouth and nose during sneezing by using masks or tissue as well as the persons covid- suspected should place medical masks in public places and closed rooms and after every sneeze; the patient must wash their hands well (with an alcohol-based hand rub or with soap and water), as a result of coming into contact with respiratory secretions; a proper and careful approach should be taken to eliminate all waste from patient uses [ ] , reducing as much as possible the exchange of equipment between patients and sterilizing them well when transporting them from one patient to another and after patient care, appropriate doffing and disposal of all ppe and hand hygiene should be carried out journal of immunology research [ ] . at the level of additional precautions for health care workers (hcws), a specialized team must be identified to deal with the patients to limit the spread of infection through protection methods, including the use of a medical mask, use of gloves, wearing of eye protection or facial protection, and wearing a clean, nonsterile, and long-sleeved gown; health care workers are prohibited from touching their eyes and nose with gloves or uncovered hands and limit the number of hcws, family members, and visitors who are in contact with suspected or confirmed covid- patients [ , ] . at the level of additional precautions for the environment surrounding patients, the surfaces and places that patients come in contact with should be sterilized regularly; ensure adequate ventilation in the health care facility; separation of at least one meter should be maintained between all patients and manage laundry, food service utensils, and medical waste in accordance with safe routine procedures [ , ] . the last section is on administrative policies and regulations that include educating caregivers on how to dealing patients, developing policies and plans through which early recognition of acute respiratory infection potentially caused by covid- virus, preventing overcrowding in public places as much as possible, ensuring that the necessary equipment for health care is provided in sufficient quantities and permanently, providing protection to quarantine areas by the authorities to reduce patients' contact with healthy people, and imposing sanctions on those who violate the provisions that have been put in place by the authorities to limit the spread of the covid- virus [ ] . in conclusion, covid- has become a high risk to the general population and healthcare workers worldwide. however, scientific research is growing to develop a coronavirus vaccine and therapeutics for controlling the deadly covid- . hence, health education on knowledge for disease prevention and control is also important to control and reduce the coronavirus infection rate. further research should be directed toward the study of sars-cov- on animal models for analyzing replication, transmission, and pathogenesis in humans. the authors declare that there is no conflict of interest regarding the publication of this article. covid- infection: origin, transmission, and characteristics of human coronaviruses world health organization, laboratory testing for coronavirus disease (covid- ) in suspected human cases, world health organization outbreak of pneumonia of unknown etiology in wuhan china: the mystery and the miracle pneumonia of unknown aetiology in wuhan, china: potential for international spread via commercial air 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health care world health organization, decontamination and reprocessing of medical devices for health-care facilities, world health organization physical interventions to interrupt or reduce the spread of respiratory viruses this work was supported by grants from the cnrst of morocco, (project ppr / / ppr ). key: cord- - qh efs authors: inchausti, felix; macbeth, angus; hasson-ohayon, ilanit; dimaggio, giancarlo title: psychological intervention and covid- : what we know so far and what we can do date: - - journal: j contemp psychother doi: . /s - - -w sha: doc_id: cord_uid: qh efs the coronavirus covid- and the global pandemic has already had a substantial disruptive impact on society, posing major challenges to the provision of mental health services in a time of crisis, and carrying the spectre of an increased burden to mental health, both in terms of existing psychiatric disorder, and emerging psychological distress from the pandemic. in this paper we provide a framework for understanding the key challenges for psychologically informed mental health care during and beyond the pandemic. we identify three groups that can benefit from psychological approaches to mental health, and/or interventions relating to covid- . these are (i) healthcare workers engaged in frontline response to the pandemic and their patients; (ii) individuals who will experience the emergence of new mental health distress as a function of being diagnosed with covid- , or losing family and loved ones to the illness, or the psychological effects of prolonged social distancing; and (iii) individuals with existing mental health conditions who are either diagnosed with covid- or whose experience of social distancing exacerbates existing vulnerabilities. drawing on existing literature and our own experience of adapting treatments to the crisis we suggest a number of salient points to consider in identifying risks and offering support to all three groups. we also offer a number of practical and technical considerations for working psychotherapeutically with existing patients where covid- restrictions have forced a move to online or technologically mediated delivery of psychological interventions. the coronavirus (covid- ) is a newly emergent infectious disease caused by the novel severe acute respiratory syndrome coronavirus (sars-cov- ) virus, originated in december from mainland china, with initial cases emerging from the city of wuhan, hubei province (cdcp ; li et al. ) . although most individuals diagnosed with covid- present with mild to moderate respiratory symptoms, a substantially minority present with severe symptomatology, with accompanying need for hospital treatment, a further proportion needing intensive care unit (icu) admission, and an elevated fatality rate. risk of mortality follows a clear age gradient (verity et al. ). on th january , world health organization (who) officially declared the covid- epidemic as a public health emergency of international concern, followed by designation as a pandemic on th march (i.e., presence of illness across multiple continents). the rapid spread of covid- places huge strain on capacity, responsiveness and resilience of public and private healthcare systems worldwide (emanuel et al. ; legido-quigley et al. ) . across multiple countries this has been accompanied by implementation of public health policies significantly altering everyday life, such as the quarantine of citizens for significant periods of time, with both short-and longer-term consequences for psychological distress and wellbeing . at time of writing, the worldwide cases of covid- are steadily increasing across all continents. on th april , the cumulative total of individuals presenting with confirmed covid- was , , people, with a total of , deaths (who ). in many countries testing is limited to hospitalised cases, therefore these numbers are likely to significantly underestimate the true prevalence of covid- in the population, given they do not cover mild presentation and asymptomatic cases. there is emerging evidence of the psychological impact of covid- on populations, both directly due to the distress accompanying confirmed cases in individuals and their loved ones, and indirectly due to population health interventions such as quarantine. however, it should be emphasized that the majority of people are not expected to suffer from mental disorders emerging from the pandemic and its impact (taylor ). however, a significant percentage will experience intense emotional adjustment reactions, including fear of contagion (zhou ) , impact of prolonged quarantine xiao ) , the death of relatives , or increased social adversity as a consequence of geopolitical instability to civil society associated with the economic crisis (silva et al. ) . in china, a survey of people found that . % assessed the psychological impact of the situation as moderate-severe, . % reported moderate to severe depressive symptoms, . % moderate to severe anxiety symptoms, and . % moderate to severe stress levels. most respondents ( . %) spent between and h a day confined at home and the main concern ( . %) was that his/her relatives would become infected with covid- . based on our survey of preliminary current research and on previous literature on coping with past coronavirus-based epidemics (e.g. severe acute respiratory syndrome, sars; and middle east respiratory syndrome, mers) we identify three groups at risk for psychological morbidity during and after the covid- pandemic. the first group are healthcare professionals, particularly those working in inpatient physical health settings, who experience higher frequency of exposure to the virus and higher viral load in the workplace; compounded by significantly increased workload, high risk procedures and the low availability of necessary personal protective equipment (ppe). thus, health professionals are at risk of elevated levels of depression, anxiety and sleep disorders , and many among them harbour fears of being infected during work shifts. recent findings on medical students in the current crisis supporting this (al-rabiaah et al. ) . this is also in line with previous experiences from sars/ mers, showing frontline health professionals constitute a unique risk group, especially after pandemic containment ends and systems move towards mitigation of the disease impact (gardner and moallef ; lee et al. ) . of note, many other workers are exposed to the same risk and fear of contagion, such as police officer, postal carrier, emergency medical technicians or trash collectors. the second elevated risk group that should be considered include individuals who, as a result of the crisis, have been exposed to potentially traumatic events such as loss of a loved one, threats to one's health and to the ability to work and make a living, and concerns about their future capacity to maintain a sufficient income. these people may express symptoms of post-traumatic stress disorder (ptsd), depression or complicated grief disorder, consistent with the literature on psychological and psychiatric sequelae of global emergencies or disasters (goldmann and galea ) . this group may not emerge immediately within the pandemic, and presentations may only become apparent after several months, even after the incidence of covid- has peaked. a third group of people at increased risk for psychological problems consists of people with pre-existing psychopathology, especially those with severe or complex psychiatric disorders. their existing presentation may be exacerbated by extreme isolation due to exposure to either the virus or associated social distancing. in this sense, social distancing may exacerbate existing social isolation in this vulnerable group. there is conflicting evidence from previous studies on the responses of people with severe psychiatric disorders to different types of disasters such as earthquakes, with some evidence for higher levels of avoidance-related coping being associated with higher distress (horan et al. ), but other studies showing that this risk is somewhat disorder specific with pre-disaster mood and anxiety disorders, but not psychotic disorders, predicting further psychological distress (katz et al. ) . this group also includes individuals with more common psychopathologies (e.g. depression and anxiety) who were receiving primary care mental, health treatment or psychotherapy prior to the onset of covid- restrictions. other people exposed to psychological suffering are those who have to live alone during the quarantine, who has been recently bereaved by the coronavirus, but the bereavement process has been disrupted by the lockdown, and ones that are not allowed to visit their loved ones who are in hospital for whatsoever medical conditions. as duan and zhu ( ) highlight, specialized psychological intervention for covid- should be dynamic and flexible enough to adapt quickly to the different phases of the pandemic. in the early stages, clinical psychologists, psychotherapist and psychological intervention specialists should actively collaborate with the rest of the multi-professional healthcare system in the treatment of the immediate impacts of covid- presentations (mohammed et al. ) . this may take the shape of organising or enabling healthcare systems to orientate towards psychological impacts of a pandemic, facilitate public mental health approaches to increasing population awareness of mental health; or organizing systems for psychologically informed interventions. this may also include task-shifting of psychological interventions either to delivery through digital means, or by different professional groups. potential therapeutic targets include: . training and support for health professionals at 'high exposure risk' to identify and manage emotional reactions, that may hinder their clinical work in frontline health delivery. this includes, for instance, managing anxiety, fear of contagion, episodes of acute stress or promoting self-care/reducing burnout. the main objective of this approach is to maximise psychological resilience in as many professionals as possible who have frontline duties during a pandemic (chen et al. ). importantly, in the peak of a pandemic, interventions such as psychological debriefing, critical incident stress debriefing or any other single session intervention mandating staff to talk about their thoughts or feelings are not recommended. that said, compassionate and sensitive awareness of the impact of critical care on health care professionals can be used to facilitate one on one support, should that person wish it (nice ). . next it is important to engage emotionally vulnerable groups, especially people with previous psychopathology. the main goal here is to support individuals undergoing covid- treatment or preventative quarantine. the mental health symptoms of this group of patients with covid- should also be monitored, although the presence of non-essential professionals such as psychiatrists, clinical psychologists or social mental health workers in isolation rooms for covid- patients is completely discouraged. therefore, front-line psychological support either needs to be facilitated by medical staff involved in immediate care (which may not be possible if the health system is at capacity) or be implemented indirectly through telecare systems. serious psychiatric emergencies such as aggression, self-harm or suicide attempts will still need to be addressed in person. for patients with acute symptomatology and diagnosed or suspected covid- , professionals who assist them face-to-face should be protected to minimize the risk of contagion (e.g. via appropriate ppe) and ensure both their safety and that of the patient. all other outpatient psychological interventions can be effectively carried out by digital care. phone and internet enabled psychological interventions have been demonstrated to be clinically effective in a wide variety of mental disorders (irvine et al. ). related to this, it is also important to tailor standard mental health delivery for individuals with pre-existing psychiatric disorders to acknowledge the impact of social isolation and distancing on mental health as part of adaptation to 'life under lockdown' or quarantine. . relatives of patients admitted by the coronavirus in a severe condition, poorly prognosed or who have already died. in such interventions it is essential not to pathologize the normal emotional reactions of family members and it is important to establish clear and consensual criteria with all the professionals involved to determine whether intervention is more beneficial than not to do so (von blanckenburg and leppin ). as the pandemic plateaus, and societies begin to emerge from distancing, mental health symptoms such as hypochondriasis, anxiety, insomnia or acute stress, as well as symptoms consistent with ptsd are expected to present across health systems. in these cases, the first-line intervention should be psychological, minimizing as far as possible the use of drugs (nice (nice , . furthermore, the literature emphasizes the importance of not starting formal psychological treatments quickly and without careful assessment, including active monitoring. as noted above, although well intentioned, intervening in individual's natural coping mechanisms too early can be detrimental. there is evidence that these interventions may be ineffective or even increase the likelihood of developing ptsd (nice ) . special attention should also be paid to: potential for "re-traumatization" of ptsd presentations where trauma-focused therapies are implemented without adequate psychotherapeutic frameworks and structures (duckworth and follette ) ; and guarding against the development of interventions for those that have recovered from covid- that stigmatize or block access of the to a new functional identity as survivors of the pandemic (muldoon et al. ) . going forward it is also crucial to ensure individuals affected by covid- retain a sense of their overall identity, and that this is not subsumed into an explanatory model reduced to the illness. any intervention should be based on a thorough assessment of possible risk factors that may maintain the problem, the patient's prior state of mental health, the history of bereavement, the presence of a history of self-harm or suicidal behaviours in both the patient and his/her family, the history of previous traumas, and the socio-economic context of the patient. at this stage, it is also important to recognise the likely profound impact of covid- on economic, social, and political levels at all levels from the individual to international. this may, therefore, require mental health systems to adopt new ways of working with structural inequalities emerging from the aftermath of covid- and consistent with a social determinants of mental health model (e.g., lund et al. ). in organizing psychological assistance within and across various stages of the pandemic, we highlight four major challenges: . healthcare system deficits, both in terms of material and human resources (i.e., lack of adequate ppe, infrastructure for digital interventions, staffing) or in mental health professionals not specialized in the psychological approach of crises and emergencies (shultz et al. ; shultz and neria ) . in china, the scarcity of human resources led to individual professionals accumulating multiple responsibilities, reducing the effectiveness of their interventions (duan and zhu ) . for this reason, government, policy makers and health managers need to be aware of health systems strengthening for increasing the capacity of mental health professionals, facilitate training for emergency intervention, and monitor workload burdens, especially when sustained over time. . societal underestimation of the (short-and long-term) psychological consequences of pandemics and, consequently, limited resources to cope with them (bitanihirwe ). there is evidence that individuals exposed to public health emergencies have increased psychopathological vulnerability both during and after the potentially traumatic event (fan et al. ) . although the international covid- pandemic response has been unprecedented in terms of mobilisation of resource and finance, there will also be long-term impacts in terms of treatment burden, including mental health, particularly in low resource and conflict settings (un ). in china, the progression of covid- aggravated the mental health of infected patients, the general population and health professionals (duan and zhu ). therefore, it is important to evaluate and identify all risk groups and adapt interventions to their specific needs. among the variables to consider are disease trajectory, severity of clinical symptoms, place of treatment (inhome or out-of-home isolation, icu, etc.), history of previous trauma and, previous history of mental health problems. having this information will help classify people at risk and enable specific preventive mental health measures to be put in place. . poor planning and coordination of psychological interventions, especially when they are applied at different levels and by different professionals (zhang et al. ). in china, at the start of the covid- outbreak, the absence of adequate planning of psychological interventions led to fragmented or disorganized implementation, compromising effectiveness and efficacy, and hampering access to available health resources. any psychological intervention should be planned and coordinated together with all the social-health stakeholders involved, particularly primary healthcare services and specialized mental health services. this maximised the potential for adequate continuity of care even after acute phase of the pandemic recedes. . finally, there is also a risk attached to early crisis responses, leading to a proliferation of interventions and frameworks associated with an oversupply of well-intentioned but potentially non-evidence based, psychological assistance, often non-governmental organizations (ngo) and the third sector. this is not to say all ngo interventions are compromised, and indeed prevention in mental health is highly desirable. that said, delivery of preventive interventions must be balanced by delivery and/or supervision applied by appropriately qualified professionals (loewenstein ; ogden ). as previously noted, where health systems have sufficient flexibility, for those with existing mental health conditions should continue their psychological interventions by technology enabled means. this can include telephone consults, or increasingly via digital platforms such as skype, zoom or health provider developed platforms. this presents a number of specific challenges including familiarity with the technology (both therapist and client), adaptation of the therapeutic intervention, awareness of the additional parameters of delivering therapy in lockdown conditions, and the accompanying question of the purpose of therapy in such unusual circumstances. there are thus several difficulties that psychotherapists and practitioners have in adjusting their practice to technology enhanced therapy, which is now delivered from their own homes, as opposed to familiar public facilities or private practices. the following suggestions of how to adapt psychotherapy to this unique condition have emerged from our everyday clinical experiences over the adaptation to lockdown in several countries, and represent an attempt to systemize clinical practice for the duration of the emergence and of social life restrictions. therefore, we provide a number of key points to guide clinicians in adapting practice. -draft a new contract. many patients will have difficulties in accepting digital psychotherapy. clinicians must be clear that this is pragmatically the only option available (if this is the case), but also acknowledge and selfregulate their own difficulties with changes such as worry for the client's mental health, irritation with the option of discontinuing face to face psychotherapy or guilt at the idea of not being available enough. in all of these cases the clinician remains open for phone/video contact where the patient experiences psychological problem, but negotiation is required over whether sessions are for crisis-management only; or whether regular sessions are still possible and/or desirable to both parties. this can help retain a balance between acceptance of difficulties and the maintenance of a robust treatment framework. -raise the bar for what we consider psychopathology. reactions of distress, such as fear, rage, anxiety, obsessions, guilt, constriction, rebellion against authority, emotion and behavioural dysregulation, albeit transitory, are to a certain extent normal during a crisis. the clinician must first and foremost help the patients understand that their suffering is human and mostly unavoidable, this is not to say that they should be ignored or minimised. when patients can note how their mind is overwhelmed by symptoms, affect or relational problems, this creates a basis for agreement to work on them. -common factors (e.g., norcross and lambert ) are even more important than usual. in particular, we think that validation, sharing and self-disclosure become of uttermost importance. validation follows from the above, that adjustment to the 'new normal' is normal and patients experience is human. therapists can note how experiencing fears for their own and their loved ones health is understandable, that to be worried about the future of the economy is reasonable, how to behave with a certain degree of obsessions is adaptive (e.g. hand hygiene) or that unexpected losses of temper are to be expected in confinement. where sharing is appropriate, the clinician may provide examples of witnessing the same experiences and noting this is part of what the humanity is experiencing now. this is aimed at reducing feelings of self-shaming, self-criticism stigma, or guilt for one's own weaknesses. self-disclosure is unique in this aspect. above all, it is one of the most powerful interventions (safran and muran ) and in this moment becomes even more necessary. therapists may need to strategically disclose moments of their own personal vulnerability during the outbreak. we contend that in this moment clinicians should mindfully and tactically not stick to one of the principles of good self-disclosures (e.g., dimaggio et al. ) , that is clinicians should disclose well-regulated feelings and thoughts. in this moment, still having command over their own experi-ences, clinicians may disclose moments in which they experienced momentarily feelings of fear, even moving closer to panic, worry, anger, sadness, rebellion and irritation than one ordinarily would. this helps create a sense of human connection and reduces in session risk, on the client's side of self-blaming or setting unrealistic standards of good mental health for the self (safran and muran ; inchausti et al. ). this can be balanced in session with learning from these experiences of momentary dysregulation. -create the therapeutic environment. we are not working in our offices but often from our homes. the therapy space must be therefore be created anew. for video-therapy the clinician should choose what part of their home they want to show beyond their shoulders and possibly consider the patients' personality. equally, the therapists will be projecting a sense of their own identify in these choices. with some patients it is better to choose a more neutral/professional background, for example bookshelves or a working table. with other patients there is less this need, and they experience a sense of familiarity even when they see the kitchen of the windows of the therapists' home. in any case, asking patients for feedback about how they experience the therapist in this new environment is crucial. another issue is how to present oneself in the camera. absence of embodied intersubjectivity deprives the session of face-to-face aspects of the human connection. we consider that adjusting zoom of the webcam, which means placing oneself at some distance can be helpful. showing only one's face is artificial and deprives the client of gestures and nonverbal markers from the therapist. conversely, at least a halflength shot (e.g. breaking news conductors) is better and some background must be present, so the patients retains a sense of a human being in context. this way therapists can use arms and hands and chest and shoulders to convey nonverbal signals making communication more natural. alternatively, some patients may feel more comfortable without using a camera and the use of audio might suit them better. coping with such anxiety disorders as social anxiety might lead patients to avoid video. as in any form of coping, if using video is too much of an emotional burden to that client, the clinician accepts phone consultation, but keeps exploring the possibility to switch to video, which would be a kind of behavioural exposure. a compromise would be using a web platform with video disabled. simply accepting coping deprives the clinician the possibility to counteract psychopathology. whereas, gently asking if the patient feels ready to switch to video, and explore the cognitive-affective antecedents of the possible refusal gives precious information about residual maladaptive interpersonal schemas which are one fundamental therapy target. -help patients build their own environment. clinicians may offer suggestions for how to create a therapeutic space, safe and protected from interference. of course, having a private, distraction-free room is best, but even in this case patients can be suggested to use headphones and a microphone, and maybe some background music, so reducing the risk others listen. alternatively, sessions can be conducted over smartphone in the open, for example a private garden, the parking lot or one's car. trivial as they may sound, we have found these suggestions help many patients to accept and practice therapy even after initial reluctance. -therapeutic focus -only self-regulation and overcoming distress or exploration of opportunities for building healthy parts and pursuing autonomy, exploration and expanding the healthy self (dimaggio et al. ) . we have noted that in majority of cases where we have adjusted delivery of psychotherapy to fit the pandemic restrictions, patients are seeking a balance between acceptance of the current condition, whilst still trying to challenge maladaptive schemas and develop an emergent healthy part of the self. indeed, once issues relating to the present crisis have been dealt with, patient and therapist may explore how the current distressing conditions create suffering not only for their direct traumatic effects, but also because they may indirectly bring existing personality, cognitive and emotional vulnerabilities to the fore. thus, clinicians may help the patients connect their present experiences to lifelong vulnerabilities, enabling therapeutic work to continue as they did before the emergency, albeit with specific adaptations. for example, prior to lockdown patients with avoidant personality disorders may have started questioning schemas of themselves as inferior and others are judging and therefore, they coped with social avoidance (inchausti et al. ) . in this moment behavioural experiments aimed at increasing social contact and thus further challenging the schemas are more difficult to enact. yet, the clinician may still explore opportunities, and build more basic steps for future real-life exposures. patients looking for employment may be able to access online courses or training for life after. patients searching for romantic partner may use dating apps or explore the feelings and thoughts they experience when chatting with some new acquaintance. even the home may be a test ground for new experiments. one client related difficulty in showing personal vulnerabilities to significant persons because she had learned that if she revealed these emotions others either became unavailable or distressed; therefore, she had avoided disclosure, or felt guilty for burdening them. lockdown and having to live with her partner : helped her realize that there was no point in her concealing her personal feelings, thus she burst into tears with her partner; relating afterwards in therapy that she felt relieved as she realized that that was possible. this enabled schema-driven difficulties in continuing with disclosure of feelings could be addressed as a current therapeutic issue. finally, some practices like two-chairs, sensorimotor work, guided imagery exercises, can regularly be performed simply adjusting the zoom in the patient room. the therapists may ask the client to step back so the whole body can be observed and then ask to close their eyes and engage in guided imagery, or use bodily oriented work like grounding (lowen ) to enhance self-regulation or connecting with feelings of strength and personal agency. that said, for some patients that are unwilling or do not want to use this platform for treatment. if they are content to postpone specific elements of treatment until restrictions are lifted, the therapist should be sensitive in recognizing distress but also respecting the decision-making process. it is still possible to remain open to the patient recontacting the therapist to recommence therapy. to conclude, the covid- pandemic and associated disruption to society poses major challenges to the provision of mental health services. these challenges include the need to identify and monitor possible risk groups for psychological morbidity as well as exploring new ways of providing services. as a heuristic, it is useful to consider three (potentially overlapping) groups that can benefit from psychological frameworks for mental health, and/or treatment approaches. these are (i) healthcare workers engaged in frontline response to the pandemic and their patients; (ii) individuals who will experience the emergence of new mental health distress as a function of being diagnosed with covid- , or losing family and loved ones to the illness, or the psychological effects of prolonged social distancing; and (iii) individuals with existing mental health conditions who are either diagnosed with covid- or whose experience of social distancing exacerbates existing vulnerabilities. there are yet limited data on the mental health impacts of the current crisis, but evidence from past epidemics (e.g., mers and sars) offer a basis for identifying risk groups and preparing management strategies. the current crisis is the first global crisis in the age of mass internet supported communication, and this offers opportunities and challenges for delivering high-quality psychological therapies online. practical and technical adjustments to therapy can and have already been made, but as the pandemic unfolds it will be important to generate a corpus of knowledge both on the effectiveness of technologically supported psychotherapy, and to share technique in working with patients in an environment where technological changes intersect with societal changes due to the pandemic. middle east respiratory syndrome-corona virus (mers-cov) associated stress among medical students at a university teaching hospital in saudi arabia monitoring and managing mental health in the wake of ebola the psychological impact of quarantine and how to reduce it: rapid review of the evidence coronavirus disease (covid- ) mental health care for medical staff in china during the covid- outbreak metacognitive interpersonal therapy for personality disorders: a treatment manual psychological interventions for people affected by the covid- epidemic retraumatization: assessment, treatment, and prevention fair allocation of scarce medical resources in the time of covid- longitudinal trajectories of post-traumatic stress disorder symptoms among adolescents after the wenchuan earthquake in china psychological impact on sars survivors: critical review of the english language literature mental health consequences of disasters stress and coping responses to a natural disaster in people with schizophrenia el trastorno de personalidad por evitación: una propuesta de tratamiento especializado en la sanidad pública española [the avoidant personality disorder: a proposal for specialized treatment in the spanish national health system proceso psicoterapéutico en los trastornos del espectro psicótico tratamientos psicológicos para la psicosis are there interactional differences between telephone and face-to-face psychological therapy? a systematic review of comparative studies research on psychiatric outcomes and interventions subsequent to disasters: a review of the literature psychological impact of the mers outbreak on hospital workers and quarantined hemodialysis patients. comprehensive psychiatry the resilience of the spanish health system against the covid- pandemic early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia dissociation debates: everything you know is wrong the language of the body. london: macmillan general reference social determinants of mental disorders and the sustainable development goals: a systematic review of reviews mental health in emergency response: lessons from ebola. the lancet anxiety disorders. quality standard. retrieved march , , from www.nice.org.uk/guida nce/qs . national institute for health and care excellence (nice) psychotherapy relationships that workevidence-based therapist contributions do no harm: balancing the costs and benefits of patient outcomes in health psychology research and practice negotiating the therapeutic alliance: a relational treatment guide the ebola outbreak and mental health: current status and recommended response trauma signature analysis impact of economic crises on mental health care: a systematic review the psychology of pandemics. preparing of the next global outbreak of infectious disease covid- global humanitarian response plan estimates of the severity of covid- disease psychological interventions in palliative care immediate psychological responses and associated factors during the initial stage of the coronavirus disease (covid- ) epidemic among the general population in china coronavirus disease (covid- ) technical guidance: infection prevention and control/ wash a novel approach of consultation on novel coronavirus (covid- )-related psychological and mental problems: structured letter therapy recommended psychological crisis intervention response to the novel coronavirus pneumonia outbreak in china: a model of west china hospital psychological crisis interventions in sichuan province during the novel coronavirus outbreak publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations conflict of interest we have no conflicts of interest to disclose. key: cord- -f q di t authors: pietrabissa, giada; simpson, susan g. title: psychological consequences of social isolation during covid- outbreak date: - - journal: front psychol doi: . /fpsyg. . sha: doc_id: cord_uid: f q di t perceived social isolation during the covid- pandemic significantly has had an extraordinary global impact, with significant psychological consequences. changes in our daily lives, feeling of loneliness, job losses, financial difficulty, and grief over the death of loved ones have the potential to affect the mental health of many. in an atmosphere of uncertainty, it is essential that clear and precise information is offered about the problem and how to manage it. in this contribution, a rationale is provided for an urgent call for a rapid response to the mental health impacts of covid- . moreover, suggestions for individuals to regulate their emotions effectively and appropriately are provided. the mental health consequences of covid- are already visible and even by conservative estimates they are yet to reach their peak and likely to considerably outlive the current pandemic. the most common psychological disorders emerging are anxiety and panic, obsessive-compulsive symptoms, insomnia, digestive problems, as well as depressive symptoms and post-traumatic stress (rogers et al., ) . these are not only a direct consequence of the pandemic but also largely driven by the effects of prolonged social isolation -that is the objective lack of interactions with others (leigh-hunt et al., ) . the medical journal the lancet recently published an article from which a clear and alarming picture emerges: periods of isolation, even less than days, can have long-term effects, with the presence -up to years later -of psychiatric symptoms (brooks et al., ) . although necessary to limit the spread of the epidemic, in fact, human beings are not "designed" to manage segregation for a long time. as the greek philosopher aristotle reminds us, man is a "social animal, " unable to live isolated from others, since the absence of relationships removes essential conditions for the development of personal identity and the exercise of reason. although our first instincts may be to react angrily at (and with) people who pour out onto the streets, there is a need for a more universal compassionate stance -and recognition that the very nature of the human being is in stark contrast with the situation we are experiencing. moreover, research shows that nourishment and movement -besides being important therapeutic expedients -are a fundamental vehicle for communicating with ourselves, others, and the world, and have an enormous influence on our biopsychological balance. prolonged isolation can adversely affect physical and emotional health, altering sleep and nutritional rhythms, as well as reducing opportunities for movement (cacioppo and hawkley, ) . as a result, the natural channels of human expression and pleasure become depressed, with attendant impacts on mood and subjective well-being (nardone and speciani, ) . furthermore, in accordance with current regulations, we have begun to behave "as if " other people are potentially dangerous for our health and for the health of our loved ones. this turn of events has cultivated a new universal belief based on vulnerability-to-harm, whereby proximity to fellow humanbeings poses a direct threat (nardone and portelli, ) . to date, more and more people are avoiding social relations, no longer by imposition, but as a choice. a decision initially moved by the fear of an invisible enemy and by the total uncertainty about what is right to do/not to do, to say/not to say, to think/not to think, derived from the informationambiguous and conflicting -that we have received. in turn, this determines behavior that will gradually replace our old worldview and interpersonal relationships. while the levels of environmental stress continue to rise, we are witnessing the deterioration of relationships. rather than connecting people, restrictive measures are creating rivalries and arousing discord between people. as conveyed by the latin phrase "divide et impera" (literally divide and conquer), an authority that exerts high levels of control and division in governing a population, tends to fragment them. the magnitude and impact of fragmentation can be influenced substantially by leadership style. grandiose leadership, for example, may create the seductive illusion of safety, with claims of invincibility and omnipotence, while providing an outlet for a range of grievances associated with inequalities and poverty through paranoia and blame of perceived "enemies. " these processes provide fuel for xenophobia and deeper divisions within society (case and maner, ; o'reilly and hall, ) . anger and nervousness, unspoken and lasting, come back to haunt us with psychological problems. likewise, spending an unusual amount of time together in confined spaces -often unsuitable for the purpose itselfincreases the risk of conflicts and domestic violence. china has experienced a significant rise in separations and divorces, particularly stressful events, which can act as a triggerespecially among the most sensitive -for the development of mental health problems, primarily depression. on the other hand, prolonged social isolation characterized by reduced social connections and contact, generates deep disconnection among those who live alone or cannot rely on an adequate social network, thus increasing the likelihood that depressive symptoms will emerge. social isolation has been linked to cognitive impairment, reduced immunity, increased risk of cardiovascular disease, and ultimately, mortality (cohen et al., ; bassuk et al., ; barth et al., ; heffner et al., ) . the association between physical frailty and social isolation has been linked to heightened inflammatory activity, as indicated by increased levels of c-reactive protein and fibrinogen (loucks et al., ) . social isolation and loneliness are related concepts and often coexist -loneliness can lead to isolation, and vice versa (shankar et al., ) . loneliness has been an emerging issue in society in recent years, and has been linked to depression, irritability, and preoccupation with negative self-related thoughts, alongside a % increase in risk of premature death. research suggests that this has been a growing problem in industrialized countries, with approximately one-third of the population affected, and one in people affected at a severe level. further, it appears that income and socioeconomic status are no barrier to loneliness -everyone is equally at risk holt-lunstad and smith, ) . loneliness is increasingly recognized as a public health issue, especially due to the detrimental effects on health and potential for premature mortality (grant et al., ; cole et al., ; murthy, ; yanguas et al., ; bzdok and dunbar, ) . loneliness is associated with feelings of emptiness, sadness, and shame, alongside the subjective perception that one is disconnected from others. it not only can occur in the context of social isolation but can also persist beyond this and can be experienced even when others are physically present. like social isolation, loneliness has been linked to depression (cacioppo et al., ; han and richardson, ) , increased cortisol levels (edwards et al., ; miller, ) , lowered immunity (cole et al., ) , and clinical disease, with attendant increases in length and frequency of hospital stays (thurston and kubzansky, ; hawker and romero-ortuno, ) . further, social isolation and loneliness may be stronger predictors of suicidality than other well-known risk factors, such as anxiety and hopelessness (hom et al., ) . in spite of the clear risks associated with loneliness, treatments to date based on cognitive-behavioral principles have shown poor outcomes (masi et al., ) . with the onset of covid- , enforced social isolation is likely to be exacerbating what is already a significant issue in our society (hughes et al., ) . added to this is the devastating and understandable impact of concerns related to economic problems and the loss of a loved one. during the coronavirus epidemic, we are forced to deal with death in ways unrelated to human civilization: from the thought of not being able to be with the deceased in his/her last moments of life, to the sense of guilt for the idea of having inadvertently infected the person, to the distress of not being able to properly honor him/her with a funeral ceremony, fundamental to the process of mourning -these are all factors that amplify the pain of death, increase the rates of depression, the consumption of alcohol, drugs and risky behaviors and, in the more extreme cases of suicide. unlike the common and ineliminable moments of crisis that characterize the existence of each of us -which, although destabilizing, represent a unique and fundamental opportunity to review personal strategies for problem management -in this period, people are experiencing impotence, vulnerability, and a feeling of loss of control over one's life as a response to something indeterminate in time and space. this generates anguish for an uncertain future and, once again, favors the appearance of depressive symptoms -especially in those most frontiers in psychology | www.frontiersin.org vulnerable, including those who already suffered from mental health problems and in health workers. those who have been placed in quarantine and those working on the front lines to deal with the epidemic are also at risk of being stigmatized: as possible "plague-spreaders, " they are viewed with fear and suspicion. certainly, some will prove to be more resilient than others and will be able to count on the presence of greater personal, social, and economic resources, but we all will be affectedto varying degrees -by the impact of this revolution on our way of living and relating to each other and on our physical and psychological health. the environmental stressors that characterize this particular historical moment clearly suggest the risk of a new epidemic, and this time there are signs it could be our mental health; but the national health system, once again, may not be ready to stem the effects of the epidemic. as the reality of social isolation persists throughout and beyond the pandemic, loneliness and interpersonal disconnection will emerge, particularly for those most socially vulnerable. psychophysical exhaustion, anxiety, fear and pain, anguish, trauma, and anger -these emotions alternate, mix, and grow in intensity to the point of overwhelm, leading to clinically significant psychological disorders, such as "reactive depression. " while the covid- crisis increases the risk of depression, depression affects the individual's ability to solve problems, set and achieve goals, and function effectively, at work and in relationships, making recovery from the crisis even more difficult. in fact, even if it manifests in different ways, at the basis of depression there is always an attitude of renouncement. people gradually lose any form of active reactivity in the face of life's difficulties: there is an increasing tendency to complain, let off steam, and rely completely on others in the management of themselves, all actions of delegation, therefore of renunciation. and, as described by emile cioran, the renunciation is nothing more than "a small daily suicide. " feeling safe and protected is a fundamental primary need of the human being to be able to move freely in the surrounding world, as well as the feeling of having control over the events of our own life. when all this fails, when the belief that whatever we do will not improve things begins to develop, a sense of "learned helplessness" takes hold, blocking any possibility of liberation or change. the anguish we experience is a normal human response to a serious crisis. recognizing and accepting these feelings prevents them from turning into disorder. giving up, delegating, and complaining are all attitudes that at the beginning of a crisis can help us, but after several months can become entrenched, self-perpetuating, and end up complicating the situation, evolving as a slow drift into a depressive mindset. recognizing these patterns immediately in one's thought processes and behavior is the best way to move in the opposite direction and to break the vicious circle that leads to global renunciation -and that characterizes the most severe depressive forms. this pandemic will inevitably lead to redefining our relationship styles, which will no longer be based on proximity but on distance. physical contact will be replaced by negotiated sharing, while the digitalization of lives, already started with the advent of social media, technology, and virtual reality, will be further emphasized, thanks to medical-scientific legitimacy. abandoning the idea that "things will go back to normal" and facing the changes taking place with flexibility mitigates the onset of psychopathology. the human being -by nature -is extremely flexible -facilitating adjustment to the reality that change will become the new normality (rossi et al., ) . in lao tzu's words, "water is fluid, soft, and yielding. but water will wear away rock, which is rigid and cannot yield. as a rule, whatever is fluid, soft, and yielding will overcome whatever is rigid and hard. this is another paradox: what is soft is strong. " but it takes time. specific treatment options are available for the most problematic situations, and more available than before the advent of the coronavirus, as mental health professionals -even the most resistant -are -flexibly -offering online support and advice. first, however, there is a need for higher level changes: state economic support measures are crucial responses to both the economic recession and the psychological depression. institutions must ensure that this experience is as tolerable as possible for people. alarmist messages, such as the emphasis on the negative aspects of the pandemic (number of seriously ill people or deaths) rather than on the positive ones (number of recovered), the abuse of alarmist expressions ("death even among young people"), and stories rich in personal details about the victims, are as counterproductive as excessive references to positivity and optimism, which, on the other hand, produce a paradoxical effect: the unrealistic nature of the messages may lead to greater mistrust and perhaps dismay ("they do not tell it as it is"). even vague or ambiguous messages ("if we are united, everything will be fine, " "be responsible, " "stay alert, control the virus") dilute the desired effects. human resilience is closely linked to the depth and strength of our interpersonal connections, including our involvement in groups and communities. in contrast, loneliness appears to be one of the greatest threats to our health, survival, and well-being. in an atmosphere of uncertainty and fear, it is essential that clear and precise information is provided on the problem and on the management of the emergency. greater cultural and economic investments will therefore have to emerge to support better and more timely prevention, treatment, and rehabilitation programs in the field of mental health, because "there is no health without mental health. " frontiers in psychology | www.frontiersin.org september | volume | article the original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author. lack of social support in the etiology and the prognosis of coronary heart disease: a systematic review and meta-analysis social disengagement and incident cognitive decline in community-dwelling elderly persons the psychological impact of quarantine and how to reduce it: rapid review of the evidence the neurobiology of social distance the neuroendocrinology of social isolation social isolation and health, with an emphasis on underlying mechanisms loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses divide and conquer: when and why leaders undermine the cohesive fabric of their group social ties and susceptibility to the common cold myeloid differentiation architecture of leukocyte transcriptome dynamics in perceived social isolation transcript origin analysis identifies antigen-presenting cells as primary targets of socially regulated gene expression in leukocytes elevated macrophage migration inhibitory factor (mif) is associated with depressive symptoms, blunted cortisol reactivity to acute stress, and lowered morning cortisol social isolation and stress-related cardiovascular, lipid, and cortisol responses the relationship between depression and loneliness among homebound older persons: does spirituality moderate this relationship? social determinants of discharge outcomes in older people admitted to a geriatric medicine ward social isolation, c-reactive protein, and coronary heart disease mortality among community-dwelling adults loneliness and social isolation as risk factors for cvd: implications for evidence-based patient care and scientific inquiry a systematic review of help-seeking and mental health service utilization among military service members a short scale for measuring loneliness in large surveys: results from two population-based studies an overview of systematic reviews on the public health consequences of social isolation and loneliness relation of social integration to inflammatory marker concentrations in men and women to years a meta-analysis of interventions to reduce loneliness social neuroscience. why loneliness is hazardous to your health work and the loneliness epidemic knowing through changing: the evolution of brief strategic therapy mangia, muoviti, ama. firenze: ponte alle grazie grandiose narcissists and decision making: impulsive, overconfident, and skeptical of experts-but seldom in doubt psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the covid- pandemic the anxiety-buffer hypothesis in the time of covid- : when self-esteem protects from loneliness and fear for anxiety and depression loneliness, social isolation, and behavioral and biological health indicators in older adults women, loneliness, and incident coronary heart disease the complexity of loneliness gp drafted and edited the manuscript. ss critically revised the manuscript. all authors contributed to the article and approved the submitted version. key: cord- -fxqseibh authors: badyal, dinesh kumar; mahajan, rajiv title: chloroquine: can it be a novel drug for covid- date: - - journal: int j appl basic med res doi: . /ijabmr.ijabmr_ _ sha: doc_id: cord_uid: fxqseibh coronavirus disease (covid- ) has been declared a pandemic by the world health organization. the united states food and drug administration has not approved any drug or vaccine for the treatment of covid- ; however, reports have emerged from different parts of the world about the potential therapeutic benefits of existing drugs. chloroquine and phosphate hydroxychloroquine are the drugs currently in the limelight, and recently, the national task force for covid- constituted by the indian council of medical research has recommended the use of antimalarial drug hydroxychloroquine for prophylaxis of severe acute respiratory syndrome-coronavirus infection in selected high-risk individuals. this short write-up explores the potential efficacy and established safety of chloroquine in covid- . it is a challenging time for the entire medical world to manage coronavirus disease (covid- ), a respiratory illness caused by severe acute respiratory syndrome-coronavirus (sars-cov- ) which is closely related to severe acute respiratory syndrome-cov (sars-cov). this virus belongs to betacoronavirus which also contains sars-cov and middle east respiratory syndrome-cov (mers-cov). [ , ] the treatment of the patients with covid- is the major challenge as mortality ranges from % to % as compared to seasonal influenza ( . %). [ ] more than , , cases have now been reported to the world health organization (who), and more than , people have lost their lives as of march , . the disease started in december in china and spread to countries as of now. the number is increasing day by day. it has been declared a pandemic by the who. [ ] the therapeutic options being tried are based on the earlier experiences with other viral outbreaks, i.e. sars/mers as well as genomic sequence of the new virus. many potential drugs including ribavirin, interferon, lopinavir-ritonavir, corticosteroids, penciclovir, nitazoxanide, this is an open access journal, and articles are distributed under the terms of the creative commons attribution-noncommercial-sharealike . license, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. for reprints contact: reprints@medknow.com nafamostat, remdesivir, favipiravir, oseltamivir, azithromycin, baricitinib, and traditional chinese medicine are being explored. [ ] [ ] [ ] [ ] however, as of now, there is no united states food and drug administration-approved drug or vaccine available for covid- . [ ] chloroquine an old drug with established safety and efficacy in malaria is being talked about so much so that it is going out of stock due to panic buying. chloroquine, an antimalarial, antiamoebic, immunomodulatory, and a potential broad-spectrum antiviral drug, is being reported to be effective in covid- . chloroquine was discovered by hans andersag in . [ ] chloroquine phosphate is being recommended in malaria in chloroquine-sensitive plasmodium falciparum malaria and is the first choice of drug in plasmodium vivax malaria as per a national program in india. the recommended dose for treatment in malaria is mg base ( mg salt) orally immediately, followed by mg base ( mg salt) orally at , , and h. the total dose is mg base ( mg salt) over days. the loading dose on day is needed due to the large volume of distribution. the prophylactic dose is mg weekly to be started week before entering a malarious area and to continue weeks after returning. [ , ] chloroquine is extensively distributed in the entire body including lungs after oral administration. the main target cells for the sars-cov- are enterocytes and pneumocytes after it enters the body. after entry, the release of viral genome into the cytoplasm needs fusion of viral and cell membranes, and it attaches to these cells with the help of spike protein-host cell protein interaction. chloroquine blocks virus infection by elevating endosomal ph required for virus/cell fusion, as well as interfering with the glycosylation of cellular receptors of the virus. it is reported to act at virus entry and at postentry stages of the infection in vitro cells. its anti-inflammatory and immunomodulatory action can add to its efficacy in covid- . [ , , ] it is reported to be effective in covid- -associated pneumonia inhibiting the exacerbation of pneumonia, earlier conversion to virus negative, and shortening the disease duration. however, this is based on the treatment of few hundred patients, and large controlled studies are needed to confirm the claims. hydroxychloroquine, to chloroquine addition of beta-hydroxy chain, has fewer adverse effects, and less efficacy in malaria is being used in rheumatoid arthritis and systemic lupus erythematosus. it is also being explored on a similar basis for covid- . [ , , , , ] the chinese clinical trial registry has studies registered on covid- , and out of these, are on chloroquine and are on hydroxychloroquine. [ ] both chloroquine and hydroxychloroquine are -aminoquinolines and are in the national list of essential medicines of india. [ ] due to its promising results, chloroquine has been included in guidelines for the diagnosis and treatment of covid- (sixth edition) published by the national health commission of the people's republic of china. [ ] the central drugs standard control organization in india has invited applications in the vaccine/drug development, and these will be given high priority. [ ] there is no conclusive evidence as of now about prophylactic value of chloroquine in covid- , although there are many queries by health-care workers to start chloroquine mg weekly. in india, the national task force for covid- constituted by the indian council of medical research has recommended the use of antimalarial drug hydroxychloroquine for prophylaxis of sars-cov- infection in selected high-risk individuals. [ ] chloroquine is being used for more than years as an inexpensive and safe drug. the safety profile is excellent and well established over time. chloroquine can be prescribed to adults, children of all ages, pregnant women, and nursing mothers. it has milder adverse effects when taken as prescribed. milder and frequent adverse effects include gastrointestinal intolerance, i.e. nausea, vomiting, and epigastric pain. a higher dose can lead to retinal toxicity, seizures, pruritus, and photosensitivity. [ , , , ] in , stevens-johnson syndrome (sjs) was added as an adverse drug reaction into the prescribing information leaflet of chloroquine in india. sjs is a rare and serious disorder of the skin and mucous membranes. [ ] conclusion a time-tested, established safe drug, chloroquine, is reported to be a promising drug for the treatment of covid- . however, accelerated studies involving large number of patients are required to confirm the efficacy to optimize its use in the international emergency situation due to covid- . nil. there are no conflicts of interest. naming-the-coron avirus-disease-(covid- )-and-the-virus-that-causes-it breakthrough: chloroquine phosphate has shown apparent efficacy in treatment of covid- associated pneumonia in clinical studies world health organization (who). coronavirus disease (covid- ) situation report- coronavirus disease (covid- ) pandemic. available from chloroquine is a potent inhibitor of sars coronavirus infection and spread therapeutic options for the treatment of -novel coronavirus: an evidence-based approach rajasthan treats coronavirus patients with swine flu, malaria, hiv drugs this french researcher says there was a successful covid- drug trial us food and drug administration (fda) directorate of national vector borne disease control programme. directorate general of health services. ministry of health and family welfare. government of india. operational manual for malaria elimination in india therapeutic options for the treatment of -novel coronavirus: an evidence-based approach a systematic review on the efficacy and safety of chloroquine for the treatment of covid- expanding horizons for clinical applications of chloroquine, hydroxychloroquine, and related structural analogues national list of essential medicines national health commission of the people's republic of china. novel coronavirus pneumonia diagnosis and treatment plan central drugs standard control organization. directorate general of health services. ministry of health and family welfare. government of india. notice regarding regulatory pathway for r and d of drug or vaccine for covid- indian council of medical research. recommendation for empiric use of hydroxy-chloroquine for prophylaxis of sars-cov- infection central drugs standard control organization. directorate general of health services. ministry of health and family welfare. government of india key: cord- -lvahzj authors: sahin, ecem; dagli, tolga e.; acarturk, ceren; sahin dagli, figen title: vulnerabilities of syrian refugee children in turkey and actions taken for prevention and management in terms of health and wellbeing date: - - journal: child abuse negl doi: . /j.chiabu. . sha: doc_id: cord_uid: lvahzj background: the syrian crisis, which started in march , has resulted in the displacement of . million refugees predominantly to neighboring countries in addition to the internal displacement of . million people. turkey is the country hosting the largest number of refugees in the world with . million syrian refugees % of which are under years old. objective: the purpose of this article is to conduct a narrative review and analyze the vulnerabilities of refugee children in turkey from the lens of the sustainable development goals (sdg), more specifically sdg goal : good health and wellbeing, with a specific focus on syrian refugee children. moreover, this article explores the actions taken to prevent and mitigate issues that arise from these vulnerabilities. method: this narrative review article collected data from various primary and secondary sources on the turkish refugee framework including national and international legislation, governmental and non-governmental data and reports, and scientific papers. results: syrian refugee children in turkey are facing a variety of risks in terms of their health and wellbeing including communicable and non-communicable diseases, post-traumatic stress disorder, depression, family violence, child labor, and child marriage. the measures taken for prevention and response by governmental and non-governmental entities are multilateral and aim to address issues from multiple perspectives including medical, psychosocial, child protection, and legal. conclusions: the interventions and restructuring of the health system in turkey contribute to the sdg number for refugee children. the existence of a legal system which enables refugee access to health, protection, and other social services is key to achieve this goal. however, the existing system could be improved especially through solidifying the legal basis and centralizing the implementation for child and refugee protection. the engagement of all stakeholders to improve the health and wellbeing of refugee children remains vital. on the th anniversary of the signature of the convention on the rights of the child (crc), much has been achieved in terms of child rights whereas much is yet to be done, especially for refugee children. there are . million refugees worldwide, over half of whom are below the age of (unhcr, ) . protection, education, health, and access to social services remain crucial issues for displaced children in many parts of the world. within the scope of displacement, the basic rights of children highlighted in the crc such as right to life and development (ohchr, , article ), protection from physical or mental violence, injury or abuse, neglect or negligent treatment, maltreatment or exploitation, including sexual abuse (ohchr, , article ) are often endangered while on the move, in a transit location, and in the target country. since the signing of the crc by countries in , other international efforts which support a more equitable global society with a specific focus on children have emerged. the most recent and prominent one is the sustainable development goals (sdgs), which were launched in . the sdgs are a collection of global goals set as a universal call to action to end poverty, protect the planet and ensure that all people enjoy peace and prosperity (undp, ) . although the sdgs are characteristically more encompassing as a development plan rather than a child focused initiative, they specifically target issues which are primarily concerning child rights and wellbeing. indeed, there are child-related indicators integrated across the following sdgs: no poverty (sdg ), zero hunger (sdg ), good health and wellbeing (sdg ), quality education (sdg ), gender equality (sdg ), clean water and sanitation (sdg ), affordable and clean energy (sdg ), decent work and economic growth (sdg ), climate action (sdg ), and peace, justice, and strong institutions (sdg ) (unicef, ) . it is important to note that the indicators developed to measure the progress of sdgs do not specifically mention displacement and refugees (irc, international rescue committee, ) except a recent inclusion of an indicator on refugees in the indicator framework: the number of refugees by country of origin as a proportion of the national population of that country of origin (nahmias & baal, ) . nevertheless, the sdgs framework gains an additional importance in terms of conflict and forced migration as the sustainability and stability of decent life standards are more likely to be interrupted compared to the situations where these variables are absent. indeed, refugees show significantly lower progress on sdg targets while their disproportionate vulnerabilities remain invisible (irc, international rescue committee, , p. ). the syrian civil war is an example of this gap where the application of sdg principles in governmental and non-governmental levels in syria as well as refugee destination countries remains insufficient. the syrian crisis, which started in march , has resulted in the displacement of . million refugees to neighboring and developed countries (unhcr, ) in addition to the internal displacement of . million people (unhcr, , p. ). turkey is the country hosting the largest number of refugees in the world with approximately . million refugees of whom . million of syrian origin (directorate general of migration management (dgmm), m. of i., turkey, ) and % of the syrian refugees in turkey are between the ages of and (directorate general of migration management (dgmm), m. of i., turkey, ). according to the latest figures announced by the turkish ministry of interior, , children of syrian origin were born in turkey since (Özdemir, ) . the aim of this article will be to conduct a narrative review and analyze the vulnerabilities of syrian refugee children in turkey from the lens of the sdgs, more specifically sdg goal : good health and wellbeing, with a specific focus on syrian refugee children. moreover, this article will explore the actions taken to prevent and mitigate issues that arise from these vulnerabilities. in terms of health and wellbeing, several health risks and other vulnerabilities have been observed to affect syrian refugee children significantly in the turkish context since . these vulnerabilities were analyzed in the two groups: ( ) health problems, ( ) psychosocial wellbeing risks. refugees may face major challenges in sustaining their health due to a variety of reasons including unsuitable living conditions during or after migration, insufficient sanitation conditions, and accessing quality food and potable water (teague, johnston, & graham, ; cronin et al., ; toole & waldman, ; yavuz, ; bilukha et al., kirişçi, ) . access to nutritious food, quality housing, and number of people living in the same household. thus, children are faced with the threat of inadequate physical development including wasting and stunting. wasting, assessed via weight for height, indicates a severe weight loss associated with an acute situation such as lack of food or a severe disease. stunting which means low height for age, on the other hand, indicates prolonged and chronic malnutrition (pernitez-agan et al., ) . according to syrian family health survey of , overall nutritional situation in syria was poor even before the crisis has started in . in this report, the prevalence of wasting was . % and stunting was estimated as % (kingori, nasser, abdullahi, & al-asaad, ) . to evaluate the nutritional status of syrian refugee children, a study performed in different countries retrospectively reviewed data of the years and of routine health assessments of refugee children aged - months. wasting and stunting prevalences significantly differed among the six countries. the overall prevalence of wasting and stunting were . % and . % respectively. in this study, these prevalence rates for the refugee children settled in turkey was . % and . % respectively. (pernitez-agan et al., ) according to the report of demographic and health survey -syrian migrant sample conducted by hacettepe university institute of population studies, % of syrian refugee children under years old, in turkey were stunted and % were wasted (hips, a) . another study conducted by the same institute in found that only % of turkish children under the age of are stunted. the trend in stunting shows that there is a decrease in stunting of turkish children under years of age, from % in to % in % in and % in % in (hips, b . the comparison of hospital admission studies from different provinces in turkey also facilitates the visualization of the nutritional problems in refugee child health in turkey. in a study which examines the hospital admissions in a tertiary hospital in adiyaman, a northeastern province in turkey with relatively high refugee population ( , syrians comprising of . % of the total population as of june (directorate general of migration management (dgmm), m. of i., turkey, ), babies who were treated in were examined. the study found that the weight of . %, of the patients were below third percentile, which is the lower end of the acceptable range in terms of growth. (bucak, almis, benli, & turgut, ) . in another study which was conducted between the years and in one of the cities with the highest refugee population in the country, gaziantep ( , syrians comprising of . % of the total population as of june (directorate general of migration management (dgmm), m. of i., turkey, ), prevalence of underweight in the patients with a mean age of . ± . years was found as . % (user & ozokutan, ) . while the studies differ in their estimations in prevalence of malnutrition in syrian refugee children in turkey, the results indicate that malnutrition is a key issue for syrian refugee children and it is more prevalent in syrian refugee children compared to turkish children. considering the conditions of migration and post-migration, infectious diseases are one of the most prevailing health risks for refugee children. especially children who have not completed their vaccinations and who have not received preventive healthcare services in the host country after migrating may present substantial health risks to both themselves and to the non-vaccinated population in the host country (mipatrini, stefanelli, severoni, & rezza, ) . the extended immunization program, which has been in practice throughout turkey since and provides free of charge vaccination to all children, has achieved a success rate of % vaccine coverage throughout the country (hips, b). meanwhile in syria, the vaccine coverage, which was close to % prior to , has decreased to % in (who -syria, ). the shortcomings of vaccination in the context of conflict and war might become an important health problem leading to increased prevalence of infectious diseases. country-wide data suggests that among syrian refugees living in camps in turkey, % and % were not vaccinated for polio and measles respectively. the percentage of unvaccinated refugees living outside the camps were even higher for these viruses ( % for polio and % for measles). this poses a public health threat for the population where refugees reside (tayfur et al., ) . in addition to problems in decreased coverage for individual vaccines, not completing all age appropriate vaccines is another threat. according to the demographic and health survey, the rate of children aged between - months who have completed all age appropriate vaccinations in refugee and non-refugee children were % and % respectively (hips, a). there have not been any reported outbreaks of infectious diseases associated with the lack of vaccination of syrian refugees and the extended immunization program is working towards the immunization of syrian refugee children as well as turkish children. however, the decrease in vaccination rate of children in syria since the start of the conflict and recent low rates of vaccination among refugee children pose a public health risk. . . . vaccine-preventable diseases . . . . poliomyelitis. polio, which was one of the most feared diseases in the early th century, was taken under control with discovery of two effective vaccines in s. with global polio eradication initiative, which started in , global incidence of polio cases has decreased by % (polio global eradication initiative, ). in , only confirmed cases of polio were reported globally (hamborsky et al., ) . turkish health system has worked very hard with vaccination campaigns for polio eradication. last reported case in turkey was in and no new cases have been reported since then (who -turkey, ). eradication program was also effective in syria as vaccination coverage was very high and no cases were present until when new cases were reported (who -syria, ). fortunately, no disease with polio virus has been reported after refugee influx in turkey although as stated above vaccination might have been missed during migration and entering the host country. in the context of conflict and migration, it requires utmost attention to avoid the reemergence of an eradicated disease. . . . . measles. measles is a highly communicable disease with complications in approximately % of cases. the complications of measles are most common among children younger than years of age (hamborsky et al., ) . the measles vaccine has been in use since the s and vaccination has drastically reduced global measles deaths. although a % drop was observed between - worldwide, measles is still common in many developing countries. the overwhelming majority (more than %) of measles deaths occur in countries with low per capita incomes and weak health infrastructures (who, ) . in turkey, measles was a common disease in , with , cases reported. with successful elimination program, incidence of cases decreased to less than cases/year between - . parallel to increased incidence in european countries after , measles cases started to increase in turkey too. in , , cases of measles were detected (who turkey statistics, ). as a response, catch-up and mop-up measles vaccination campaigns were conducted for turkish citizens and syrian refugees in cities with high refugee population and consequently the number of measles cases decreased to in (ergönül et al., ) . according to turkish ministry of health, intensive immunization efforts have successfully controlled the disease, but virus is known to circulate in the country. (ministry of health, ) . in turkey, only cases were reported in and cases were reported in (who -turkey, ). measles can be controlled through vaccination. as immunization protects % of vaccinated individuals and prevents disease transmission if vaccination coverage is over - % (doherty, buchy, standaert, giaquinto, & prado-cohrs, ) . when coverage is reduced as it was in turkey in , number of cases sharply increased. while the sudden increase in the number of cases in was not related to syrian refugees, it is likely that the vaccination was not conducted in syria properly. that is why it is important to vaccinate newly arrived refugees to turkey since a susceptible population increases the likelihood for the spread of infection both for immunized individuals as vaccine protection is not % but especially for unvaccinated citizens in the country. hepatitis a is an infection acquired through contaminated food or water and in areas with low socioeconomic levels disease is highly endemic. with increasing hygienic conditions disease prevalence rates show an age shift towards older ages. in turkey, hepatitis a vaccine (hav) was added to childhood vaccination scheme by the end of with two doses of vaccine performed at th and th months. incidence rates of hepatitis a in turkey have declined over the past years, due to socioeconomic development and introduction of vaccine (demiray et al., ) . in syria, hav vaccination was not included in the national immunization program prior to the start of the conflict. in and , at the beginning of the conflict, high numbers of hepatitis a cases were reported. a study performed in izmir with syrian refugees admitted to outpatient clinic of a hospital revealed that more than half of the children did not have protective level of antibodies against hepatitis a (köse et al., ) . in temporary shelters in turkey, , hepatitis a cases were diagnosed between and and most of the cases were children (ergönül et al., ) . hepatitis a outbreak is likely in situations with poor hygiene conditions. since syrian refugee children are not vaccinated against hepatitis a, their protective antibody levels are low. while the incidence in turkish children is low, it is important to vaccinate syrian children to prevent potential outbreaks. . tb is a communicable disease affecting mainly lungs but other organs as well. only a small percentage of people who are infected with mycobacterium tuberculosis develop the disease and for most of the infected people, the infection remains dormant. even so, tuberculosis is still one of the top causes of death (who, ). incidence of disease is higher among children with risk factors such as undernutrition. bacille-calmette-guérin (bcg) vaccine which was developed almost years ago, is still the only vaccine against this disease. tuberculin skin testing with purified protein derivates (ppd) is used for diagnosis and it determines exposure to tb bacilli and infection in a person. in turkey, children are vaccinated with bcg vaccine for prevention of tuberculosis with % coverage rate and incidence of disease is per , population (who turkey statistics, ). in syria tb incidence is per , population. bcg vaccination is available but coverage rates decreased to % from % from to (who syria statistics, ). refugee children might have a higher risk for tb infection due to this decrease in coverage of bcg vaccine in their countries and they may have disease especially if they have nutritional problems as discussed previously. in a study to evaluate results of ppd test applied at the tuberculosis dispensary between - , performed in hatay, one of the border provinces ( , syrians comprising of . % of the refugee population as of june (directorate general of migration management (dgmm), m. of i., turkey, )), positive ppd reactions and annual risk of tuberculosis infection were found to be more common among syrian refugees compared to local population, more specifically in the - age group (savaş, barutcu, & yeniçeri, ) . another study revealed that in temporary shelters for refugees in turkey, active tuberculosis cases were detected and treated (ergönül et al., ) . the presence of active tb cases related to syrian refugees indicate that preventive strategies for tb should be emphasized. refugees are susceptible to other infectious diseases that are not vaccine preventable. between and , high numbers of incidences were reported in syrian refugees residing in temporary shelters in turkey such as respiratory tract infection ( , , cases), diarrhea ( , cases), and bloody diarrhea ( cases) (ergönül et al., ) . a study conducted between and examined the hospital admissions of syrian patients in a tertiary pediatric hospital in turkey's capital city ankara ( , syrians comprising of . % of the total population as of june (directorate general of migration management (dgmm), m. of i., turkey, )). the most common admission reasons were found to be respiratory tract diseases and diarrhea (güngör et al., ) . these diseases are likely to have serious consequences in children as they are still among the most common causes of infant mortality (who, ). cutaneous leishmaniasis (cl): cl is a disease caused by a protozoan parasite transmitted from human to human by sandfly bites and characterized by chronic skin lesions, leaving permanent scars with deformation of the infected area. outbreaks of cl have been reported in different areas in turkey in the past years, correlated with the influx of syrian refugees. in an analytical cross-sectional epidemiological study of cl cases diagnosed in the gaziantep leishmaniasis diagnosis and treatment center, out of cl patients, . % ( / ) were syrian citizens and . % ( / ) were turkish citizens. the disease was more frequent in women with . % ( / ) and in the age group between - years with . % ( / ). the increase in cl frequency is alarming and requires control and prevention measures in highly infected areas (eroglu & ozgoztasi, ; zencir & davas, ) . early recognition, treatment of cases and vector control measures are essential for prevention. covid- : during the preparation of this manuscript, a new highly infectious disease " novel coronavirus (covid- )" has emerged. the "covid- " outbreak was first identified in december in wuhan, china and was recognized as a pandemic by the world health organization (who) on march . the government of turkey has reported its first case on the same day and as of june , almost , confirmed cases were reported. since the specifics of the cases have not been shared publicly and prevalence studies have not been completed at the time of writing this article, it is not clear how many of the reported cases correspond to refugees. however, refugee populations are potentially more susceptible to contracting infectious diseases such as covid- as they are more likely to live in overcrowded shelters and substandard conditions (kluge, jakab, bartovic, d'anna, & severoni, ) . while the morbidity and mortality of covid- cases in children are significantly lower compared to other age groups, the social effects of the outbreak has had negative impacts on the living conditions of syrian families in turkey. although the literature on the impacts of covid- on syrian families in turkey is limited at the moment, studies conducted by ngos thus far confirm that syrian refugee families are facing significant challenges including someone in the household losing their job, issues with accessing health services, and having unmet urgent needs (relief international, ) . vulnerable groups such as large families or people with disabilities are likely to be disproportionately affected from the disease (danish refugee council, ). moreover, unregistered refugees reported fear of arrest or deportation should they approach a hospital (danish refugee council, ). as such, covid- outbreak presents lower risk for syrian refugee children in terms of direct impact from the disease. however, the general decline in the quality of life due to the outbreak remains to be a significant risk. refugee children and adolescents are exposed to a number of traumatic experiences during war and flight (levy & sidel, ). related to exposure to traumatic events and post-migration living difficulties refugee children are at higher risk to develop mental health disorders (fazel, reed, panter-brick, & stein, ) . while examining the mental health of refugees, risk factors during preflight, flight and post-flight periods have been shown to be related to mainly post-traumatic stress disorder (ptsd), depression, and anxiety disorders. loss of a parent appeared as a risk factor both for ptsd and depression (hasanović, sinanović, selimbašić, pajević, & avdibegović, ) . moreover, among the refugee children, the risk for mental health problems is found to be highest for the unaccompanied minors (hodes, jagdev, chandra, & cunniff, ) . there is also a dose-response relationship with increasing number of adverse events, the risk for mental health problems is increasing (montgomery, ) . moreover, parental psychopathology, such as depression is related to emotional problems among refugee children (kovess-masfety et al., ) . the risks related to traumatic events, flight, and post-flight appear quite prominent for the case of syrian refugee children. a study conducted by unhcr in found that the highest risk for syrian refugee children was psychological concern ( %) followed by children dropped out of school ( %) and child labor ( %) (unhcr, . p. ) . it is also important to mention that the risks identified in this study, including child labour (habib et al., ) , child marriages (el arab & sagbakken, ; wringe et al., ) and domestic violence (falb, blackwell, stennes, hussein, & annan, ; usta, masterson, & farver, ) in addition to the aforementioned higher risks, are factors which are likely to influence psychological wellbeing negatively. a study on mental health problems and related risk factors in turkey reported that syrian refugee children have been exposed to a number of traumatic events during war in syria prior to arrival to turkey such as witnessing explosions or gun battles ( %), to lose someone important to them ( %), to see dead or wounded people ( %), or witnessing people being tortured ( %) (gormez et al., ) . consistent with these findings, studies suggest that the prevalence of ptsd symptoms ranges from . % (gormez et al., ) to % (eruyar, maltby, & vostanis, ) , and of depression from . % (ceri, nasiroglu, ceri, & cetin, ) to % (kandemir et al., ) amongst syrian refugee children in turkey. post-traumatic stress disorder among refugee parents was found to be related to harsh parenting and higher psychological problems among refugee children (bryant et al., ) . considering the high estimates of ptsd (alpak et al., ; acarturk et al., ) , depression (fuhr et al., ) , anxiety (fuhr et al., ) and somatic distress among syrian refugee adults, and its possible impact on refugee children's mental health, provision of psychosocial interventions to adult refugees becomes an important way to contribute to wellbeing of refugee children. studies also examine the relationship between parenting styles, attachment styles and mental health of refugee children. a previous study with syrian refugee children aged - living in istanbul showed that perceived secure attachment was positively associated with warmth parenting while negatively associated with rejection parenting. moreover, parental emotional warmth, lower overprotecting and rejecting behaviors were found to be associated with lower levels of emotional and behavioral problems among syrian children (eruyar, maltby, & vostanis, ) . associated with the trauma experienced by syrian refugee children due to experiences with conflict and flight as well as parental experiences with trauma, syrian refugee children are at higher risk of mental health problems. in addition to post-war trauma, child labor is also a significant risk factor for refugee children's psychosocial wellbeing (sirin & rogers-sirin, , p. ) . child workers are preferred by employers as cheap workforce (harunoğulları, ) . children also learn foreign languages faster than adults which often makes it easier for children to find jobs compared to their parents (hilado & lundy, ). in turn, child workers are unable to attend school and play as well as often being subjected to physical, emotional, sexual, or economic abuse (ozdemir & budak, , p. ; harunoğulları, ) . a study on refugee child labor interviewed refugee children living in one of the border cities with high density of refugee population, kilis ( , syrians comprising of . % of the total population as of april (directorate general of migration management (dgmm), m. of i., turkey, )). the results of the study suggest that child labor is an important indicator for psychosocial problems in refugee children along with physical and social problems. several factors such as high number of siblings in the household, difficulties in affording rent, and issues with affording basic food needs increase psychological pressure in refugee child workers (harunoğulları, ) . . . . . domestic violence. refugee children and women are at higher risk for domestic violence which in turn have an effect on their psychosocial wellbeing (rees and pease, ) . in a recent systematic review of domestic violence in the refugee families, the ecological model of bronfenbrenner ( ) was used to examine the risk factors for family violence in individual, family, societal and cultural level (timshel, montgomery, & dalgaard, ) . parental trauma and mental illness such as ptsd and depression appeared to be significantly related to family violence in the individual level. family level risk factors included interaction between the parent and child, family structure and family acculturation stress (timshel et al., ) . the main societal level factor was low socioeconomic level of the household. finally, at the cultural level, patriarchal beliefs were identified as risk factors for family violence in refugee families (timshel et al., ) . in a recent study with syrian women in northern syria, emotional, physical, and sexual intimate partner violence were found as predictors of depressive symptoms among women (falb et al., ) . moreover, intimate partner violence in syrian families found to be increasing the violence towards children by their mothers (usta et al., ) . child marriage stands out as another risk factor for syrian refugee children's mental and physical wellbeing. even though child marriage has been prevalent in syria before the war (save the children, ), the occurrence has increased from % to % since the start of the war (unfpa, ). child marriage is an issue primarily for girls in both syria and turkey. however, the statistics show that syrian refugee girls are more likely to be married before the age of compared to turkish girls. in a representative study of turkish women aged between - , it was found that % of women were married before the age of and % were married before the age of (hips, b). for syrian refugee women, % of the interviewed women were married before the age of and % before the age of (hips, a). since marriage prior to the age of is illegal in turkey, it is difficult to reach accurate statistics of child marriage in turkey. however, academic studies and media forums have consistently flagged child marriage of syrian refugees as a serious issue. in the emergency context, refugee child marriage in turkey is often used as an economic survival mechanism for low-income families by receiving bride wealth in exchange for marrying young girls of the household but also with the perception of providing a better life for their daughters with higher economic prospects (suleymanov, sonmez, unver, & akbaba, , p. ; cetin, , p. ) . child marriage is a multilateral risk factor for wellbeing such as interruption of personal development stemming from leaving school, psychosocial effects of early parenthood, forced sexuality, and premature pregnancies which often lead to unfavorable circumstances including tendency to violence, escaping home, and suicide (suleymanov et al., , pp. , ) . about the main reasons of child marriages, a study with syrian refugees in lebanon indicated gender differences. while according to men the main reason was poverty, syrian women accept it as a protection mechanism against sexual violence and harassment (bartels et al., ) . same motives for early marriages in syrian refugees were also reported in studies from turkey and jordan (el arab & sagbakken, ; wringe et al., ). the vulnerabilities of syrian refugee children detailed in the previous sections are closely related to the targets set under sdg : good health and wellbeing. namely, provision of universal healthcare, reduction of premature mortality from communicable and non-communicable diseases, and promotion of mental health and well-being are included in the official list of sdg indicators (un statistical commission, ) . this section will focus on the actions and measures taken by governmental and non-governmental actors in turkey to improve the health and wellbeing of refugee children on these indicators while also highlighting the challenges and barriers that refugees face. the provision of organized healthcare services specifically for syrian refugees started on april , in yayladagi, hatay which was the first entry point of refugees at the time (tayfur, günaydin, & suner, ) . the provision of healthcare services was reported to be accessible in camp settings as the camp residents had direct access to health centers from the earlier years of the crisis whereas urban refugees experienced difficulties in access especially prior to (zencir & davas, ) . the legal basis for the provision of healthcare services to refugees was established with the regulation on temporary protection and the subsequent directive on the guidelines for the healthcare service provided to individuals under temporary protection. the prior established the essentials of provision of healthcare services to individuals under temporary protection whereas the latter described the specifics of healthcare provision for individuals under temporary protection including who is eligible to receive and provide healthcare services, remuneration of services, and principles of service provision. healthcare services are highly accessible for refugees and refugee children since the ministry of health ensures their provision to all syrians who are registered with the turkish authorities. the provision of services does not extend to syrians who are not registered. however, emergency care and essential public services are provided in urgent cases and the beneficiaries are referred for registration after their treatment ( rp, , p. ) . the public hospitals have been experiencing issues of capacity due to the high volume of consults from refugees, especially in border cities with a large refugee population, and this issue is causing negative perceptions and reactions from the host community (demir, ergin, kurt, & etiler, , p. ) . to ease the burden on public hospitals, the ministry of health, supported by humanitarian actors, has established migrant health centers (mhc) throughout the country to reach the increased demand. this initiative established a network of mhcs throughout turkey where syrian doctors and nurses offer linguistic-and culturally-sensitive primary healthcare services for the syrian population ( rp, , p. ). in , over , primary health care consultations were provided in the seven refugee health training centers, relating to immunization, maternal care and child health care. syrian doctors, syrian nurses and translators/patient guides were trained and , syrian health professionals have been employed by ministry of health and serving in migration health centers across the country ( rp, , p. ) . the extended immunization program (detailed under section . ) has been expanded to syrian refugee children as well as refugee children of other nationalities since with the collaboration of ministry of health and unicef (gultac & balcik, ; unicef, , p. ) . the immunization campaigns aim to protect children against a variety of communicable diseases such as polio, heamophilus influenza, diphtheria, pertussis, tetanus, measles, mumps and rubella (mmr) and hepatitis b (unicef, ). children are screened and registered to the health information system in all provinces, with a focus on the most refugee populated provinces (unicef, ) . the immunization campaign has thus far proven successful as there have not been any reported outbreaks of communicable diseases in turkey in connection with lack of immunization of refugee children. while legislation and a formal system for refugee access to healthcare services has been present since , similar efforts have been present for psychosocial services and child protection. the social services under the ministry of family, labor, and social services is the main responsible institution to ensure child protection in turkey. however, since their scope of responsibility is quite wide, there have been more specific initiatives of public-private partnerships for improving the child protection services for the host community as well as the refugee population. even though there is no refugee-specific law on child protection in turkey, syrian refugee children are under the jurisdiction of the child protection law, which aims to regulate the provisions on protection and rights of children with protection needs or children in conflict with the law (republic of turkey, ). the child protection law puts forth a series of measures to be taken for children who are in need of protection on counselling, education, childcare, health, and shelter (article ). in terms of implementation, child advocacy centers (cacs) are established under the ministry of health in turkey. the cacs aim to effectively respond to child sexual abuse cases and minimize the re-traumatization of sexually abused children by completing the judiciary and medical interventions of them in one round and location by trained professionals (bayun & dincer, ; republic of turkey, ) . the first cac was established in ankara in as a pilot project and has spread to out of provinces as of april (ministry of health, ) . the turkish prime ministry issued a circular letter in on the implementation and strengthening of cacs in order to protect vulnerable children with effective implementation of cacs. while cacs are not a refugee-specific project, the number of refugee applications has increased in the last few years. another important child protection project is the establishment of university based child protection centers (ubcpcs). the ubcpc project was kick-started in by a project technically supported by unicef and since then, ubcpcs were established in universities in different provinces of turkey. the ubcpcs are entities established under public universities in turkey and they consist of an environment to provide education, implementation, and research on diagnosis, treatment, protection, and monitoring of children in need of protection. similar to the cacs, the ubcpcs are also a non-centralized initiative and they are not refugee-specific (akco et al., ) . another project on child protection implemented with the contributions of governmental and non-governmental actors is tackling the issues in the court processing of children who have been the subject of violence'. in order to avoid further victimization of children against whom a crime was committed or who witnessed a crime, judiciary interview rooms (jirs) were established in courthouses in provinces in turkey since in partnership with ministry of justice, unicef, and child protection centers support society (cokmed). the jirs provide a safe environment for interrogating the children to give testimony in a criminal court. the interviews are conducted by an expert (with the presence of a translator if needed) in one room while the judges and public prosecutors in charge of the case follow the interview from a separate room. the judges and public prosecutors provide their inputs and questions via an ear microphone to the expert who in turn asks the question to the child in a trauma-sensitive manner. to this end, in addition to the establishment of the jirs, trainings and supplementary materials are provided to all professionals included in the process to ensure effective child-sensitive implementation (dagli, ) . complementary to the above explained jirs project, another project was implemented in on training arabic-turkish translators on child-sensitive translation in jirs by ministry of justice, unicef, and child protection centers support society (cokmed). the "child-friendly translation project in judicial processes" trained arabic-turkish translators, who are working with refugee children in jirs, in increasing their capacity in terms of their professional roles, responsibilities and limitations about interviewing techniques, special situations, as well as in terms of child friendly terminology and child sensitive approach (dagli & sahin dagli, ) . in addition to the projects detailed above, un agencies and other non-governmental organizations support the turkish government in the implementation of healthcare service provision as well as covering the gap for child protection and psychosocial services. the regional refugee and resilience plan ( rp) is the strategic, coordination, planning, advocacy, and programming platform for humanitarian and development agencies to respond to the syria crisis at the regional level and in host countries, namely turkey, jordan, iraq, egypt, and lebanon ( rp, ) . in , health and protection actors in rp sectors reported their achievements related to child health and protection, as detailed below: the non-governmental health sector actors reported in the rp health sector quarterly report for that as of end of december , the number of refugee children under five years reached through the vaccination programs is around , ( rp health sector, ) . furthermore, more than , doses of dpt vaccines have been administered to refugee children under-oneyear (which amounts to % immunization coverage) and , doses to the age group of under-five-years ( rp health sector, ) . the services provided to refugees by non-governmental organizations include basic health counseling, sexual and reproductive health services, psychiatrist referrals, psychosocial support services, training of medical personnel, and organizing awareness raising activities about hygiene, healthy nutrition, basic health rights, and sexually transmitted illnesses ( rp health sector, ) . the non-governmental protection sector actors reported in the rp protection sector quarterly report for that protection services were provided in out of provinces of turkey ( rp protection sector, ) . specifically in child protection, , children with protection needs were identified and referred to child protection services, , children were referred to specialized services, and , children participated in structured, sustained child protection or psychosocial support programs ( rp protection sector, ) . moreover, non-governmental actors focused on strengthening national systems with the aim to increase refugees' access to protection services by facilitating capacity development activities for staff and establishing social protection desks in peripheral areas ( rp protection sector, ) . as an example of public-ngo partnership, a project called 'trauma informed schools' was implemented in schools in two cities of turkey (istanbul and sanlıurfa) by maya foundation in collaboration with the ministry of health. the aim of this project was to increase the knowledge of teachers on psychological trauma related to refugees and its impact on syrian children's mental health (maya foundation, ) . furthermore, as part of the same project, refugee children with mental health problems were identified and provided psychosocial intervention. another important example of public-ngo partnership is the conditional cash transfer for education program under the partnership of the ministry of family, labor and social services, the ministry of national education, turkish red crescent and unicef. this project, which was implemented in turkey since , was expanded to syrian refugees in (unicef, ). while this is an education project, it contributes directly to avoid social risks faced by syrian refugee children including child labor and child marriage. the presence of an established system for syrian refugees' access to health and wellbeing and efforts from non-governmental organizations to increase access to these services were detailed in this section. however, it is also important to question to which extent the provided services are inclusive of syrian refugees. syrian refugees reportedly continue to experience difficulties in accessing the healthcare and psychosocial services. one of the main challenges cited by authors is the arabic-turkish language barrier. to tackle the language barrier between arabic-speaker refugees and turkish-speaker host communities, translators are employed in many public hospitals. however, the number of translators remain insufficient in most places (assi, Özger-İlhan, & İlhan, ; ekmekci, ) . the lack of legal registration of refugees in turkey or registration in a province different than the province of residence is also a prominent issue. as mentioned, syrians are only entitled to healthcare services in the provinces they are registered in. thus, refugees who reside in a different province or has not been able to register with the authorities cannot access healthcare services (assi et al., ; ekmekci, ) . furthermore, even though the healthcare services are legally free of charge for refugees, syrian refugees living in outside of the camps stated that in practice, not all services are always covered and they may need to pay for prescribed medications and other healthcare related costs (kargin, ) . finally, the stigma against syrian refugees by local communities, including healthcare workers, is negatively impacting the syrian refugees' access to healthcare. refugees stated that they were exposed to negative attitudes of healthcare staff and even received poor treatment due to the stigma associated with being a refugee (kargin, ) . this article aimed to look into the health and wellbeing of syrian refugee children from the perspective of sdg goal good health and wellbeing. the main commonality of the studies reviewed for this article is that syrian refugee children in turkey are faced with higher risks in terms of a variety of health and wellbeing indicators despite the efforts by governmental and non-governmental entities. the studies from pre-conflict syria confirm that the overall child nutrition situation in syria before the start of the war in was already poor (kingori et al., ) . in the current situation, syrian children are more vulnerable to nutritional problems than turkish children (hips, a (hips, , b . this discrepancy may stem from a variety of factors including lack of income, access to nutritious food, quality housing, and number of people living in the same household. increasing the general life quality of syrian refugees, ideally to the level of turkish nationals, is the way to tackle this issue. the improvement of living conditions is also crucial to the reduction of non-vaccine preventable diseases such as respiratory tract infection and diarrhea, which can become deadly for malnourished children (ergönül et al., ) . establishing decent living conditions with adequate shelter and sufficient income to alleviate basic food and hygiene requirements should be the main goal to protect the health status of syrian refugee children in turkey. immunization coverage of syrian refugee children and their susceptibility to vaccine-preventable diseases is a particular situation. vaccination rates in syria prior to the war were high whereas the rates have fallen significantly in syria since then (hips, a; who -syria, ) . when syrian children arrived to turkey, their vaccinations were mostly incomplete due to disruptions of the vaccinations during the war. vaccination rates have also been high in turkey in this period and turkey includes syrian refugee children in its vaccination program (hips, b) . in the last years, the vaccination rates of syrian children approach those of turkish children. while some vaccine-preventable diseases have seen an increase in numbers with the arrival of syrian refugees in turkey due to the delays in vaccination in syria since the start of the war, it is also important to note that none of them has reached the level of a serious outbreak thus far (who -turkey, ; ergönül et al., ) . regardless, it is important to pay close attention to the vaccination of syrian refugee children to avoid potential outbreaks. in light of the aforementioned vulnerabilities, the integration of refugees in the national health system is extremely important for individual and public safety. the turkish national health system is largely extended to syrian refugees free of charge and additional measures have been taken to mitigate issues of overcrowding in the public healthcare services (demir et al., ) . the extension of the national immunization campaigns to refugee children is a crucial step towards public health. in this sense, the registration of syrian children with turkish authorities should be the first priority to ensure full vaccination in order to prevent outbreaks. most importantly, the access of refugees to public healthcare services was ensured by its incorporation into legislation, which provides a sound legal basis for the provided services with the regulation on temporary protection and the subsequent directive on the guidelines for the healthcare service provided to individuals under temporary protection. syrian refugee children are exposed to various traumatic events such as loss of a loved one, witnessing combat or life threat during war and flight (gormez et al., ) . other social risk factors during post-migration period such as child labor, family violence, and child marriage also negatively affect the psychosocial wellbeing of syrian refugee children in turkey (el arab & sagbakken, ; falb et al., ; habib et al., ; usta et al., ; wringe et al., ) . associated with these risk factors, studies indicate higher estimates of ptsd, depression, and anxiety among syrian refugee children compared to turkish children. however, due to language barrier, lack of mental health professionals and stigma on mental health issues, mental health service utilization is low among syrians (fuhr et al., ) . most of the psychosocial interventions are directed to school age syrian children due to feasibility reasons such as accessibility (yaylaci, ) . a study of school-based, teacher delivered psychosocial intervention indicated reduction in symptoms of anxiety and ptsd among syrian refugee children (gormez et al., ) . however, there is also a need to develop and deliver psychosocial interventions to younger children and those children who are not going to school especially due to child labor or child marriage. social factors such as child labor, domestic violence and child marriage are also risks for refugee children's wellbeing. child labor and child marriage are commonly used as coping mechanisms for the household's economic survival (ozdemir & budak, , p. ; harunoğulları, ; suleymanov et al., , p. ; cetin, , p. ) . domestic violence is an increased risk for refugee children due to traumatic experiences affecting parental psychopathology (timshel et al., ) . this shows that wellbeing is not a one-way street and mental health support to parents as well as children is necessary for child wellbeing and economic sufficiency might have secondary serious effects on refugee children's wellbeing. while the national and local governmental and non-governmental entities have taken steps in addressing these issues, the legal basis for addressing them are not as established in comparison to the access to healthcare services. as a direct consequence of the presence or non-presence of national legislation on the mentioned issues, the provision of services differs in terms of modality. the provision of healthcare services is highly centralized, led by the ministry of health, which facilitates the harmonization of services throughout the country. however, the issues with registration with the authorities (in a different province or lack of registration) is a significant barrier for syrian refugees' access to the services provided (assi et al., ; ekmekci, ; kargin, ) . moreover, the lack of refugee-specific legislation and the narrow scope of national legislation on child protection have steered the actors to organize in a non-centralized manner. in addition to the governmental policies, the role of the civil society and its cooperation with governmental entities also presents an added value for the improvement of syrian refugee children's wellbeing. the child protection efforts are joint efforts of the turkish government and non-governmental actors in effectively addressing child protection issues ( rp health sector, ; rp protection sector, ; unicef, ; maya foundation, ) . however, at this stage, these activities are not widespread throughout the country and refugee integration is not optimal due to arabic-turkish language barrier. the expansion of the services countrywide and the integration of refugees into these systems by solidifying the capacities of arabic-turkish translators remain vital for enhancing the health and wellbeing of refugee children. the goals established in the agenda for sustainable development under paragraph include promoting physical and mental health and wellbeing, extending life expectancy, achieving universal health coverage, reducing newborn and maternal mortality, ending preventable diseases, fighting communicable diseases, and preventing and treating non-communicable diseases (united nations, ) . it is clear that the interventions and restructuring of the health system as discussed in this article are very much in line with the cited goals and contribute to the sdg number : good health and wellbeing for refugee children in the context of turkey. the provision of universal healthcare rights for syrian refugees is the main parallel with the sdg targets, which also contributes to other sdg targets including reduction of mortality from communicable and non-communicable diseases. un agencies and other non-governmental entities have also been active in the refugee response since the beginning of the crisis and have filled gaps in access to services where possible including but not limited to protection services and referrals, psychosocial services, and nutrition and food security assistance. on the other hand, significant gaps remain in terms of access to social services and the legal system. the existence of a legal system which enables refugee access to health, protection, and other social services is key to achieve this goal. however, the results of this narrative review confirm that the existing system could be improved especially through solidifying the legal basis and centralizing the implementation of child and refugee protection. considering the high number of refugee children and the demand on the health systems of turkey, engagement and capacity building of all stakeholders is essential to provide effective services to improve the health and wellbeing of refugee children. evaluation of these services in terms of impact and costeffectiveness is also important. after evaluation, evidence based services should be scaled up. to increase the delivery and reuptake of health services, barriers such as lack of awareness about available services, lack of translators, and issues with registration of syrian refugees in their provinces of residence should also be addressed. turkey is amongst the countries to distinguish the particular needs of refugees as part of its sdg voluntary national review (out of the countries, each country hosting over , refugees) (vnr, ; irc, international rescue committee, , pp. - ) . while the sdg framework aims to "leave no one behind", it is important to remember that syrian refugee children remain more vulnerable to health and wellbeing risks. the sdgs as a national response plan should not leave marginalized groups behind and particular needs of syrian refugee children should be effectively incorporated into the sdg framework. considering that turkey is currently hosting the largest syrian refugee population in the world, we can say that the steps taken in the integration of refugees in turkey in terms of sdg goals of health and wellbeing are significant. the good practices examined in this review article are as follows: -extension of universal healthcare to syrian refugees -extension of universal immunization to syrian refugee children -establishing migrant health centers to ease burden on public hospitals due to the sharp increase in demand -public, civil society, and joint initiatives for the provision of healthcare and child protection services for syrian refugee children however, parallel to the magnitude of the refugee population, there are remaining gaps to be filled and potential improvements to consider as identified in this review article: -poor living conditions (i.e. hygiene, shelter, nutrition) -issues with the registration of syrian refugees in turkey presenting challenges with access to healthcare services -shortcomings in addressing the arabic-turkish language barrier to access to services (e.g.: lack of translators in health facilities) -lack of refugee-specific legislation on child protection -narrow scope of national legislation on child protection -efforts to address the stigma experienced by syrian refugees from the local population in general including healthcare and wellbeing related service providers -limited accessibility for mental health support for syrian refugee children and their parents as such, turkey can significantly improve the current health and wellbeing situation of syrian refugee children and minimize the associated risks by addressing these points. a final point to be made while concluding this article is that in the areas which the national systems are already strong, the system is better able to absorb newly emerging urgent and heightened needs. some examples of this in the context of turkey are immunization coverage extension to syrian children or the extension of universal healthcare to syrian refugees. on the other hand, where national systems are not well established, additional shocks bring extra burden and the vulnerabilities may 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performed through infoveillance using posts from different cities to analyze what population was living or worried during this month. results presents a high concern about international context, and national situation, besides economy and politics are issues to solve. by constrast, religion and transport are not very important for peruvian citizens. public health vigilance is the practice of public health agencies that collect, manage, analyze and interpret data systematically and continuously, and spread such data to programs facilitating the measures in public health [ ] . in this field, many ways of public health analysis appear, among them, infodemiology, an emerging area of research studying the relationship between information technology and consumer health, as well as the tools of infometrics and web analysis whose final objective is to inform and collaborate with public health and public policies [ ] . along with this, it is necessary to find determining disease outbreaks in advance in order to reduce their impact on the populations. the supposed advantage of getting information provided by automated systems falls short facing the impossibility of accessing data in real time, as well as inter-operational fragmented systems, which leads to the transfer and processing of longer data [ ] . this kind of technology has been used for diseases, such as whooping cough [ ] , flu [ ] , and immunosuppressive diseases [ ] , among others. currently, we are facing coronavirus disease (covid- ) which is a viral infection highly pathogenic caused by sars-cov- . currently, it is already causing global concern on health [ ] . officially declared as a global pandemic by the world health organization (who) on march , , covid- outbreak (coronavirus disease) has evolved at an unprecedented rate [ ] . in order to help public health and to make better decisions regarding public health and to help with their monitoring, twitter has demonstrated to be an important information source related to health on the internet, due to the volume of information shared by citizens and official sources. twitter provides researchers an information source on public health, in real time and globally. thus, it could be very important for public health research [ ] . within the context of covid , users from all over the world may use it to identify quickly the main thoughts, attitudes, feelings and matters in their minds regarding this pandemic. this may help those in charge to make policies, health professionals and public in general to identify the main problems that concern everybody and deal with them more properly [ ] . this research is aimed to identify the main topics published by twitter users related to the pandemic covid . making the analysis of that information may help those in charge to make policies and healthcare organizations to assess the needs of interest groups and to deal with them properly. the remainder of the paper follows. section presents related works regarding the retrieval infectious diseases information from social media. in section , the data collection methodology for extracting relevant information of covid- from twitter is presented. section describes experimental findings and a discussion related to the analysis. finally, conclusions and future work are described in section . surveillance pretends to observe what happens over one population, region or city to support on politics decisions. one good advantage are cost and time because usually surveys are two components: collection and processing, both can spend many days, even months.. sinnernberg [ ] performs a study about twitter as tool for research on public health, is necessary to highlight researchers uses traditional databases for studies and twitter can provide useful data from people. from papers for the review, research fields as public health ( ), infectious disease ( ). breland [ ] express in social media people create content, exchange information and use this tool for communication. a four benefits from the use: a) disseminate research on public health field, b) fight against misinformation, c) influence policies, d) aid public health research and e) enhance . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . professional development. and yepes [ ] can support the affirmation: twitter is source from useful data for surveillance, considering relevant terms and geographical locations. more applications using twitter and natural language processing are found: monitor h n flu [ ] , dengue in brazil [ ] , covid symptomatology in colombia [ ] , covid infoveillance in south america countries [ ] and monitor city of mexico [ ] finally, ear [ ] found, peruvian internal agencies have overlapping functions so this can limit collaboration, there is not enough technical capacity and resources outside the capital, lima. besides, cultural diversity and geographical issues can present challenges to fight agains one disease infection. therefore, the use of a infoveillance tool based on text mining can provide a support to the goverment and public policies creation. the process to analyze the situation in peru, follows the next steps: • select the relevant terms related to covid pandemic • set the parameters to collect related posts • pre-processing • visualization the scope of the analysis is peru, and this regions so considering news about covid- , the selected terms are: the collection process is through twitter search function, with the next parameters: • date: - - to - - • terms: the chosen words mentioned in previous subsection • geolocalization: the capital of every state from peru, see this step is very important to take relevant words and this is the source to create graphics to help understanding the country. • uppercase to lowercase • eliminate alphanumeric symbols • eliminate words with size less or equal than the next graphics presents the results of the experiments and answer some questions to understand the phenomenon of the pandemic over perú country population. helping the visualisation from monday to sunday during the last two weeks, a cloud of words is presented in fig. . analyzing lima fig. , the one hundred of more frequent terms are related to cases of coronavirus and extracting a value according to the data analysis, it can be seen the regions including words related to "entertainment" issues such as, lambayeque, la libertad, piura and loreto, those which have the highest level of contagion in peru. this issue is related to social and culture differences of the northern coast of the country. a similar case occurs when searching words related to "religious" issues, where regions such as, cajamarca, cuzco and huanuco, include them due to their traditions, common in the zone. see fig. , that since the current situation has made the population to "abandon" some customs and to adopt . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint other new ones, for many people it was hard to adopt these recommended measures firstly, so they has had to look for them by using social networks. another point to consider is that, besides the information on covid , the international information related to the situation in other countries is present in every region. this kind of information is followed by domestic issues from the national situation. publications referring to regional or local issues are scarcely present, see fig. . this may be because, even though health is an aspect that causes society concern, regarding prevention, information coming from the national government is preferred. a similar scenario is present in all the regions, mass media the social network explored is useful to provide data for a exploratory analysis, to know what concerns can have citizens and map the issues per city so public policies can be more efficient and located. peruvian citizens have a high concern related to covid , international context and economy, politics from national context and a minor worrying about religion, transport. digital disease detection -harnessing the web for public health surveillance infodemiology: tracking flu-related searches on the web for syndromic surveillance infodemiology for syndromic surveillance of dengue and typhoid fever in the philippines monitoring public interest toward pertussis outbreaks: an extensive google trends-based analysis infodemiology and infoveillance: tracking online health information and cyberbehavior for public health disease monitoring and health campaign evaluation using google search activities for hiv and aids, stroke, colorectal cancer, and marijuana use in canada: a retrospective observational study novel coronavirus disease (covid- ): a pandemic (epidemiology, pathogenesis and potential therapeutics) covid- , sars and mers: a neurological perspective using twitter for public health surveillance from monitoring and prediction to public response top concerns of tweeters during the covid- pandemic: infoveillance study twitter as a tool for health research: a systematic review social media as a tool to increase the impact of public health research investigating public health surveillance using twitter pandemics in the age of twitter: content analysis of tweets during the h n outbreak building intelligent indicators to detect dengue epidemics in brazil using social networks what is the people posting about symptoms related to coronavirus in bogota, colombia infoveillance based on social sensors to analyze the impact of covid in south american population text mining approach to analyze coronavirus impact: mexico city as case of study towards effective emerging infectious diseases surveillance: evidence from kenya, peru, thailand, and the u.s.-mexico key: cord- - ju fcf authors: arthi, vellore; parman, john title: disease, downturns, and wellbeing: economic history and the long-run impacts of covid- date: - - journal: explor econ hist doi: . /j.eeh. . sha: doc_id: cord_uid: ju fcf how might covid- affect human capital and wellbeing in the long run? the covid- pandemic has already imposed a heavy human cost—taken together, this public health crisis and its attendant economic downturn appear poised to dwarf the scope, scale, and disruptiveness of most modern pandemics. what evidence we do have about other modern pandemics is largely limited to short-run impacts. consequently, recent experience can do little to help us anticipate and respond to covid- ’s potential long-run impact on individuals over decades and even generations. history, however, offers a solution. historical crises offer closer analogues to covid- in each of its key dimensions—as a global pandemic, as a global recession—and offer the runway necessary to study the life-course and intergenerational outcomes. in this paper, we review the evidence on the long-run effects on health, labor, and human capital of both historical pandemics (with a focus on the influenza pandemic) and historical recessions (with a focus on the great depression). we conclude by discussing how past crises can inform our approach to covid- —helping tell us what to look for, what to prepare for, and what data we ought to collect now. the health and economic toll of the covid- pandemic continues to expand throughout the globe, impacting countries both rich and poor. as it does so, the virus exposes the strengths and weaknesses of our healthcare systems, political institutions, media, and our economies themselves. much of the discussion to date has understandably focused on stemming the immediate costs of the covid- crisis: among them, mortality, business failures, job losses, and foreclosures. this pain is salient, and as such, very obviously demands an urgent response. however, there are potential outcomes of the current pandemic which, while perhaps less salient, also merit urgent attention: namely, long-run damage to human capital and wellbeing. it is to these particular long-run effects that we turn our attention in this paper. the potential for long-run harm to human capital arises from two main facts about the current pandemic. first, key features of covid- -among them its geographic reach, its relatively high ease of transmission, its comparatively low lethality, and its many emerging sequelae-have given rise to widespread and potentially lasting morbidity among its many survivors. second, the pandemic has sparked an unprecedentedly large downturn, which in its own right has the capacity to permanently scar trajectories of health and income, even for those who do not fall ill themselves. while the costs of these long-run effects may seem far away, they are latent today and could become massive down the line: burdening healthcare systems and government assistance programs, suppressing work capacity and human capital investment, and reducing economic prosperity more generally. luckily, the returns to avoiding these harms, or to acting swiftly to compensate for them before they have a chance to compound, tend to be much higher the sooner interventions can be made (see, e.g., heckman, ; almond & currie, ) . together, the potential for diffuse and latent adverse effects, and the cost-effectiveness of early remediation, suggest that in addition to any efforts to address the immediate pain of the pandemic, our eyes should also be on the future-and on actions we can take now to mitigate the long-run pain for affected cohorts, and therefore, the wider economy. but what, exactly, is the long-run human fallout of covid- likely to be-and who will bear the brunt of this crisis? to answer these questions, we need the sort of long-run view that only history can provide. an obvious starting point is to look to evidence from historical pandemics. despite potential differences in empirical settings and epidemiological characteristics, the sheer number and diversity of past pandemics means that covid- has many close historical analogues as a health crisis. for instance, while the current pandemic is frequently described as unprecedented, in many ways, its immediate effects on health are not altogether anomalous. with cases first appearing in december , sars-cov- , the pathogen behind covid- , spread throughout the world in a matter of weeks, with deadly consequences. by the end of april , worldwide cases had topped million, and fatalities exceeded , . as of this writing in late october , and with the pandemic still spreading, cases exceed . million, and fatalities have surpassed . million. for context, deaths from h n (swine flu) in - were smaller in magnitude, with estimates of over , deaths attributable to the virus (dawood et al., ) . while at million deaths, the hong kong flu of is comparable to covid- in its death toll to date, the asian flu of was substantially deadlier, killing million people. likewise, cholera, typhus, smallpox, measles, and tuberculosis all have had high death tolls, including during the th century. reaching even further back, the black death left a devasting imprint on the world, killing a third of europe's population. clearly, historical pandemics offer a rich evidence base that can help shed light on the range of possible long-run effects of covid- through morbidity and mortality. however, there is one crucial aspect of the current pandemic that sets it apart from all but the most catastrophic historical disease outbreaks : the presence of an acute public health crisis alongside massive and widespread economic disruptions. not just that-it is the fact that this health crisis has precipitated an economic one. to wit, efforts to stop the spread of the virus, alongside failures to contain it, have contributed to a dramatic slowdown of the global economy. consider, for instance, the economic dislocation experienced in the u.s., a country which quickly came to lead the world in both confirmed covid- cases and deaths. in march and april of , roughly percent of the united states' labor force filed unemployment claims. double-digit unemployment would continue through the summer. the dow jones fell by over percent. for contrast, during influenza pandemic, responsible for roughly , deaths in the u.s. (glezen, ; simonsen et al., ) , unemployment peaked at . percent, and the dow fell percent-certainly a recession, but nothing on the order of what we have already experienced during the covid- outbreak, just a few months in. the unprecedented scale of the covid- economic downturn relative to past pandemics is apparent in figure , which shows the evolution of u.s. gdp over time, with major epidemics highlighted. notes: annual gdp per capita data for through are taken from https://www.measuringworth.com. quarterly real gdp per capita data for and are taken from https://fred.stlouisfed.org/series/a rx q sbea and deflated to plague would continue to impact economies into the th century, with an outbreak in san francisco infecting individuals and killing (echenberg, ) . the san francisco outbreak presents interesting parallels to . despite health officials identifying the plague and urging action, california's governor, henry gage, denied there was an outbreak, partly out of a desire to prevent business losses from a quarantine. it took the intervention of federal authorities and a new governor to implement proper measures to stop the spread of the plague. california officials reacted quite differently to covid- , at least initially, swiftly imposing stay-at-home orders. a century later, the calculus of weighing an economic slowdown against the spread of disease has changed. despite a much larger population, and a much more widespread pandemic, covid- had claimed under lives in san francisco county as of late october , thanks in part to these relatively early and stringent interventions. for instance, the aids crisis and the black death may be some of the only other major pandemics where mass morbidity and mortality were accompanied by dramatic and widespread economic dislocation. dollars to match the historical data. code to generate the figure and the underlying data for it can be found at open-icpsr (https://doi.org/ . /e v ). clearly, this feature of the current pandemic calls for complementary evidence if we are to understand its potential for long-run harm: there is no suitable all-in-one historical analogue for covid- , and evidence from past pandemics alone is likely to understate the potential for damage to (or intervention in) health and welfare through income and labor-market channels. indeed, to continue with our u.s. example, the two-trillion-dollar coronavirus aid, recovery, and economic security act's closest comparison, is not to be found in past responses to health crises, but rather in the response to past macroeconomic crises-e.g., the american recovery and reinvestment act in the case of the great recession, and the new deal in the case of the great depression. federal outlays as a percentage of gdp rose from . percent at the start of the great depression to . percent by . the cares act alone is equal to roughly percent of gdp, and this does not account for additional relief that may be approved in the coming months. asset purchases in response to the great recession increased the federal reserve's balance sheet from $ . billion in to $ . trillion in . that balance sheet has gone from $ . trillion in february of to $ . trillion just four months later. by nearly any metric, covid- has generated both an economic crisis and a government response of historic scale. studying how individuals emerged from these primarily economic disasters, and what role government fiscal interventions played in their recovery, may therefore help us flesh out the incomplete perspective we would gain from studying past health shocks alone. turning to a combination of historical crises, then-past pandemics and recessions, both-allows us to consider events that in many ways more closely mirror current circumstances, and whose contextual differences can themselves be informative of our current situation first, and most crucially, these events have had time to fully unfold: the short-, medium-, and long-run consequences of these events can be directly observed. second, the diverse array of historical events, settings, and mechanisms provides a set of reasonable analogues for covid- , even as our understanding of covid- evolves. third, the economic history literature shows how much can be learned with clever analysis of even incomplete or imperfect data. missing and inaccurate health data is unfortunately directly relevant to assessing the spread of covid- , given, for instance, current issues with testing and coordination. thus, a historical perspective allows us to use rich data to look at not only the short-term effects of crises like covid- on health, labor, and human capital, but also the long-term and intergenerational impacts along these dimensions for both individuals and the wider economy. in so doing, it can offer us insight on the current crisis-telling us what to look for, what to prepare for, and what data we ought to collect now. put another way, understanding the lingering health and economic impacts of these past crises offers valuable insight for anticipating and responding to the potential long-term impacts of covid- . to examine how history can inform our view of the coronavirus pandemic and associated policy responses as they relate to long-run wellbeing, we begin in section ii by reviewing the features of covid- that will determine its potential health and economic impacts, and placing these features in historical context. then, in sections iii and iv, respectively, we narrow our focus to two of the closest analogues to the current pandemic-one, the influenza pandemic, which speaks to -direct‖ health-channel effects; and another, the great depression, which speaks to -indirect‖ effects through the labor market and wider economy. there, we review the economic literature on the short-and long-term effects on cohorts exposed to these massive shocks, and discuss how these short-run experiences can give rise to lasting, and sometimes hidden, damage. we conclude by discussing what economic historians and researchers of covid- can offer each other. before we can look to historical evidence on how covid- 's effects may unfold in the long run, it is useful to fix ideas about key features of the current crisis-its epidemiology, its demographics, and the policy responses to date. comparing these features to those seen in past pandemics offers a sense of which historical pandemics might serve as the most useful points of reference going forward. we draw here on the principles outlined by morens et al. ( ) to categorize pandemics. they point to eight characteristics common to most accepted definitions of a pandemic: ) wide geographic extension and ) disease movement, which speak to the disease's spatial reach; ) high attack rates and explosiveness, ) infectiousness, and ) contagiousness, which speak to how it spreads; ) severity, which speaks to its potential for population scarring and culling; and ) minimal population immunity and ) novelty, which speak to the scope for harm and the speed with which preventive and therapeutic responses can be marshalled. by all measures, covid- presents these hallmark features of a pandemic. understanding exactly how covid- reflects each dimension is essential for understanding the likely short-and long-run consequences of the pandemic. the widespread nature of pandemics makes their health and economic impacts particularly devastating: with effects felt everywhere, it becomes increasingly difficult to shift economic activity to, or medical resources from, unaffected areas. while the true extent and timing of covid- cases is yet to be determined, the evidence to date indicates that the global spread of the virus has been incredibly rapid. the earliest reported cases appeared in december in wuhan, china. that same month, the virus made it to france. by january , there were confirmed cases throughout asia, europe, north america, and africa, and by the end of the month, the number of cases worldwide reached , . in the months that followed, that number rose sharply-first to , in february, , in march, and over , , by the end of april. by may , only sovereign states had no confirmed cases, of which are island nations in oceania. covid- had become a truly global pandemic by the end of spring , and both cases and fatalities have continued to rise across the globe in the months that followed. this feature of covid- surely has much to do with the highly globalized nature of our modern economy. indeed, we see similar patterns in historical pandemics, reaching as far back as we have had extensive trade routes. nearly every country with reliable mortality statistics displayed excess deaths from the influenza pandemic . similarly, the plague pandemic originating in canton and hong kong in spread to ports across five continents (who, ) , and even the justinian plague of reached asia, africa, and europe. even in a historical era where countries were less tightly integrated than they are today, as of late october , there have been nearly million cases of covid- worldwide, and over million deaths-and, as winter dawns on the northern hemisphere, and as we enter a new and possibly more lethal wave of the pandemic in many parts of the world, these numbers seem poised to rise further. even though world economies are substantially more tightly integrated than in the past, even in the preindustrial era, alfani & murphy ( ) document that it was common for disease to be transmitted along trade routes or through inter-regional commercial contact. big trading centers in particular, such as amsterdam, london, and venice, frequently faced outbreaks of plague (see alfani ( ) , biraben ( ) , and curtis ( ) for the underlying studies). the only thing that truly spared an area from pandemics was isolation. with the increase over the last few centuries in both global connectedness and population density, the implications for our current crisis are clear. the speed with which a disease spreads directly impacts the difficulty of containing it. indeed, it is these transmissibility-related features that account for many of the public health measures seen in response to the current crisis-some, such as early international travel restrictions, which tried to contain a disease that in many countries was already being spread locally via community transmission; and some, such as stay-athome orders and mask-wearing, which have been more effective in slowing transmission once it was too late for a containment strategy to be tenable. high attack rates and explosiveness (multiple cases appearing in a short time span) make it hard to stay ahead of a disease. these characteristics are functions of a disease's infectiousness and contagiousness: its ability to spread from person to person. covid- is transmitted by respiratory droplets and aerosols produced when an infected person coughs or sneezes. this has led to covid- having a daunting rate of transmission, with early estimates of a basic reproductive rate of between and (sanche et al., ) . as a point of reference, these transmission numbers are akin to those seen for past sars, polio, mumps, yellow fever, and influenza outbreaks (see figure ). the economic history of these pandemics thus provides a guide for what we might expect from the covid health crisis. for contrast, the economic history of measles-which presents far higher transmission rates, with estimates of basic reproductive rates greater than (guerra et al., )-offers a sense of how much worse things could be. notes: case mortality rates are for untreated patients. for covid- , basic reproduction rates are taken from https://wwwnc.cdc.gov/eid/article/ / / - _article. all other reproduction and fatality rates are taken from https://docs.google.com/spreadsheets/d/ khcewy-d hxlwrft jjrq xf whqlmwyrxel wjxkw /edit#gid= (the data the opening up of regions to trade, or conquest, has generated a large literature on the role of disease in shaping economies. see in particular the literature on the columbian exchange (nunn & qian, ) . the basic reproductive rate is the number of expected cases directly generated by one case when all individuals in the population are susceptible to infection. like the disease's ease of transmission, the severity with which it manifests symptoms will also be a crucial determinant of both its consequences for individuals and the wider economy, and the nature and magnitude of the government response. for instance, a highly lethal pandemic may generate extensive and indiscriminate mortality; a less lethal pandemic may generate culling (selective mortality related to a specific health threshold); and an even less lethal pandemic may generate very little mortality, but substantial health scarring among survivors. if a disease is so mild that many of those who are infected remain asymptomatic, this can, in the absence of widespread testing, undermine efforts to slow transmission. likewise, rates of infection, in combination with severity considerations, will help determine whether governments intervene, or merely wait for the disease to -take its course‖ on the way to achieving herd immunity. in its april , covid- strategy update, the world health organization note that percent of those infected experience moderate disease, including pneumonia, and percent experience severe disease. they cite a crude clinical case fatality rate of over three percent that rises to percent or higher in individuals over the age of . as shown in figure , the crude mortality rate for covid- in its first months is similar to that of the influenza pandemic and of measles, but far lower than the deadlier recent outbreaks of mers, ebola, sars, and lower still than the truly devastating historical toll of smallpox, which had an average case fatality rate of percent (ellner, ) . this rich historical spectrum of pandemic severity, in turn, demonstrates that both mild and severe diseases impact the economy, albeit in very different ways. for instance, the eradication of hookworm in the u.s. south-a disease which is not fatal, but which primarily causes lethargy and anemia-improved returns to schooling, educational attainment, and incomes in areas with high prior infection rates, but did little to change to overall demographic, economic, or institutional structure (bleakley, ) . for contrast, the black death and other pre-modern outbreaks of plague, which had extraordinarily high death tolls, fundamentally reshaped the global economy through their effects on population size and demographic structure. in this context, covid- 's wide scale and relatively low lethality will surely have a bearing on the scope, magnitude, and timescale of damages. as we will see in later sections, it suggests that we might ultimately expect to see the greatest harm only in the long run, with widespread generational scarring arising from short-run morbidity and economic disruptions. the novelty of a pandemic virus contributes to its potential for destruction: it takes time to identify a new disease, understand key features of its epidemiology, develop treatments and vaccines, and achieve a degree of population immunity. in the meantime, everyone represents a potential victim. as a novel coronavirus, it is worth emphasizing that even if a patient survives covid- , they may still face substantial harm. for instance, emerging research suggests that some covid patients may experience persistent symptoms well beyond the normal recovery period, and that others-even some with relatively mild cases-may nevertheless suffer permanent respiratory, cardiovascular, and neurological damage. voigtländer & voth ( a , b argue that the increased wages due to labor shortages from plague mortality increased demand for urban products, driving a cycle of urbanization and additional disease that moved europe out of a malthusian trap into a modern world of permanently higher per capita incomes. dittmar & meisenzahl ( ) demonstrate that outbreaks of plague aided the spread of reformation laws and the expansion of public goods. for more on the economic history of plagues, see alfani & murphy ( ) . covid- struck a population with neither natural nor acquired immunity: wherever the virus spread, it had the potential to be devastating. with little immediate means of preventing, testing for, or treating it, some of the only short-run mitigation strategies available have been relatively brute-force ones such as lockdowns and border closures. consequently, economic shutdowns-resulting both from official government actions and from individuals taking actions to avoid exposure-have been widespread, leaving no major economies or populations spared. interestingly, because medical technology was limited for much of the past, and societies could only count on some degree of population immunity, even endemic (i.e., non-novel) diseases could have the sort of destructive potential we only typically see today in new disease variants such as the novel coronavirus. for instance, in a variety of past pandemics studied by economic historians, cases of an endemic disease would sporadically rise sharply, with substantial consequences for living standards and economic organization. indeed, a large literature considers the impact of such diseases on the growth trajectories of countries over the long run, often focusing on tropical diseases like malaria, yellow fever, dengue, and others. one strand of studies considers the direct impact of disease on human capital formation (see, for example, bleakley ( bleakley ( , on malaria). another strand focuses on the impact of these endemic diseases on institutional development, finding that disease environments inhospitable to colonial settlers drove them to rely on extractive institutions that were ultimately harmful to economic growth (acemoglu et al., ) . finally, scholars have considered the way that one society's acquired immunity to an endemic disease can devastate the economy of another society lacking that immunity (diamond, ; mcguire & coelho, ; tang, ) . together, this historical evidence gives us a picture of what our circumstances might look like today if we are unable to adequately ramp up our capacity for disease prevention and treatment, and are instead forced to rely on acquired immunity, the nature of which for covid- is still poorly understood. age has been at the forefront of discussions about the disparate impact of the current crisis, and shutdown efforts have been framed in part around protecting older individuals and other vulnerable populations, such as the immunocompromised, while societies work to expand medical capacity and develop a vaccine. in this respect, covid- is much like many infectious disease outbreaks in the past-though young people can both transmit the disease and become ill, it is the elderly and those with poor baseline health are at greatest risk. cdc estimates put the risk of hospitalization five times higher, and the risk of death from covid- times higher, for to year-olds compared to individuals in their twenties. likewise, despite claims in some quarters that covid- is -the great equalizer,‖ it is already becoming clear that socioeconomic status will be central to understanding the demographics of this crisis. one of the ways low-income populations will be affected is through differential exposure to pandemic risks. individuals who continue to do their jobs in person during the pandemic-including service-industry workers with extensive contact with customers, healthcare professionals, and other frontline workers-will that is, it is improved medical knowledge that has allowed us to escape from the sort of flare-ups of endemic disease so frequently observed in the past, and it is relative our lack of knowledge about covid- , as a new virus, that makes our current situation in some ways comparable to even past endemic disease outbreaks. economic historian joel mokyr expands on this idea regarding the evolution of knowledge regarding infectious disease outbreaks in a recent op-ed: https://www.cnn.com/ / / /opinions/struggle-between-people-and-microscopic-pathogens-mokyr/index.html. retrieved from https://www.cdc.gov/coronavirus/ -ncov/covid-data/investigations-discovery/hospitalizationdeath-by-age.html, august , . the mirror image of differential exposure is differential transmission risk. this is one reason why some have called for prioritizing the strategic testing of workers at highest risk of spreading the novel coronavirus to others, particularly asymptomatic ones. bear a disproportionate burden of the pandemic's health impacts. these workers are more likely to be in low-paying jobs, and are more likely to be women and minorities, than their counterparts with jobs allowing them to work from home. consider, for instance, meat and poultry workers in the u.s. the mean annual wage in the industry is only $ , (bls, ) . among laborers in the food manufacturing industry, percent are black and percent are hispanic (eeoc, ). three-quarters of full-time, year-round healthcare workers are female, with that share even higher among the lower paid nursing and health aide occupations, critical occupations with severe risk of exposure to this disproportionate exposure to virus for lower income groups, women, and minorities is exacerbated by differences in these groups' access to healthcare and the quality of that health care-factors that affect both vulnerability and resilience to pandemic disease. membership in more than one of these groups will tend to compound disadvantage even further. preliminary research suggests that black patients exhibiting covid- symptoms were six times less likely to get treatment or testing than white patients. this is not unique to covid- : similar patterns have been observed for other modern pandemics including the h n influenza outbreaks (quinn et al., ) . the outsized impact of pandemics on minority populations and people of lower socioeconomic status has historical precedent. the influenza pandemic hit the poor first and hardest (sydenstricker, ; mamelund, ) , a point we will return to in section iii. explanations for this relationship mirror modern ones: poorer populations lived in denser housing units under worse conditions, and had occupations that increased exposure to the virus. moreover, low incomes constrained their ability to avoid exposure and seek treatment. historical evidence shows that to escape a th century outbreak of yellow fever, wealthier residents often left the city-an option unavailable to low-income workers with tenuous job security. this is a pattern that we see as well during outbreaks of plague in earlier centuries, and is part of dittmar & meisenzahl's ( ) explanation for why the black death paved the way for institutional reform: the old elites simply left town (dinges, ; isenmann, ) . this sort of regional flight is unlikely to be a central dimension along which covid- has differential impacts across income levels-but it does raise important issues that set the current crisis somewhat apart https://www.bls.gov/oes/ /may/oes .htm https://www.eeoc.gov/statistics/employment/jobpatterns/eeo / /national-naics /table?naics= &state=&cbsa= figures are based on the u.s. census bureau's calculations using american community survey data (https://www.census.gov/library/stories/ / /your-health-care-in-womens-hands.html). https://www.nytimes.com/ / / /us/coronavirus-african-americans-bias.html the relationship between pandemic exposure and socioeconomic status has not always been constant. as alfani & murphy ( ) note, studies of the plague in europe find the black death to have been universally deadly. however, plagues of the fifteenth and sixteenth centuries exhibited the negative relationship between socioeconomic status and mortality found in more recent pandemics (see, for example, slack ( ) , alfani ( ) , and carmichael ( )). however, the final major plagues of the seventeenth century once again tended to have severe consequences across all classes. mamelund ( ) note that in norway, the impacts of the pandemic were most severe for transport, hotel and industry workers, paralleling the observations above about covid- . these factors also translated into worse outcomes for minorities. as the exception that proves the rule, black americans fared better than white americans during the pandemic (crosby, ; Økland & mamelund, ) . crosby ( ) argues that the black population had disproportionately high exposure to the early, less virulent summer wave of the pandemic due to their worse occupations and living conditions, conferring some degree of immunity to the more deadly later wave. a similar mechanism operated during historical yellow fever outbreaks, albeit resulting in advantages for native-born individuals over immigrants. individuals born in an area with endemic yellow fever and exposed at a young age often contracted a mild form of the disease, and then developed immunity. as a consequence, adult immigrants were far more likely to die in yellow fever outbreaks in the united states than either native-born whites or blacks (patterson, ) . saavedra ( ) exploits this pattern to demonstrate that earlylife yellow fever exposure negatively impacted adult occupational outcomes, with white males born to immigrant mothers during yellow fever pandemics less likely to become professionals than the sons of native-born mothers. from other historical pandemics: the spatial distribution of population within and across cities, the degree of interconnection between rural and urban areas, and the extent of urban health penalties. while cities are much healthier today than in the past, societies today are also much denser, more urbanized, and better connected-all factors that would tend to make modern pandemics both faster to spread and harder to control than in centuries prior. and indeed, while covid- has hit dense metropolitan areas particularly hard, as in the past, under the current crisis, rural communities have not been spared. this is in part because of the relative ease with which people circulate between communities with our modern transportation networks, but also because of the way that the nature of modern work tends to place individuals in close contact with each other, even in less densely populated areas. to wit, major rural clusters of covid- in the united states have been tied to large meat and poultry processing facilities, with workers at these facilities experiencing case rates an order of magnitude higher than the general u.s. population (dyal et al., ) . moreover, rural areas' demographic composition (often older and less affluent) and healthcare infrastructure (often sparser) can also contribute to their difficulties with pandemic disease. to respond effectively to pandemics in the moment, and to deal with their long-run fallout, will require an understanding of its distributional effects over time and space. we explore these central consideration in depth in section iii. evaluating the policy response to covid- and how it compares to historical pandemics requires recognizing that information on the disease and how to stop its spread has been limited to date, and is still evolving. this issue stems in part from covid- being a novel disease-developing treatments and vaccines takes time, and public health recommendations can change as knowledge advances. it also stems from incomplete and inaccurate data: limitations on covid- testing has often meant relying on mortality rates rather than case rates. incidentally, this is the same approach economic historians are often required to take. morbidity data are rare historically and, when available, may be unrepresentative and inaccurate. mortality data are both far more prevalent and reliable, even if it is morbidity that is typically more relevant to the economic impacts of a pandemic, particularly less lethal ones. for health officials today, the need to assess the spread of covid- through mortality data leads to the frustration of identifying the arrival of cases with a substantial lag. for the economic historian, this lag is irrelevant, but the issue remains that only those places experiencing excess mortality can be identified; diseases leading to widespread morbidity but little mortality may be equally important for the evolution of economies, but far more difficult to identify prior to modern medical records. again, this suggests that evidence from crises that have run their course can be informative of what to expect going forward. while some of the challenges in developing effective covid-control responses have stemmed from incomplete and rapidly evolving knowledge of the disease, they have also stemmed from issues of state capacity, political will, and ideology. for instance, policymakers, firms, and individuals have been hamstrung by not only limited testing and contact tracing capacity, but also by a failure at times to deploy these tools efficiently. constraints such as these are a product of both the limitations of medical technology, and broader issues of political leadership and coordination. the inability to identify and isolate individuals at risk of spreading the disease, in turn, has necessitated rather blunt policy tools, such as business closures and stay-at-home orders. in the u.s. in particular, these covid-control efforts have been aggressively decentralized, and have tended to prioritize both commerce and individual liberty-even where these might be at odds with each other, or lead to ineffective disease control. to wit, business owners and public officials have struggled to gain widespread compliance with (and have often declined to enforce) precisely the sorts of behaviors-e.g., mask-wearing, social distancing-that would allow for the safe reopening of businesses. indeed, it appears that the fear and uncertainty created by the failure to control the spread of disease, in turn, has contributed to prolonging economic pain (goolsbee & syverson, ) . challenges such as these, related to culture and institutions, are nothing new-in fact, they characterize the u.s.'s historical experience of managing epidemic disease. in his excellent the pox of liberty, troesken ( ) lays out how the very institutional features-among them a decentralized federal system, a focus on property rights and commerce, and protection of individual liberties-that led to the u.s.'s rapid economic development also often undermined its attempts to control past outbreaks of smallpox, typhoid, and yellow fever. the examples he provides have uncanny parallels to the u.s.'s approach so far to managing covid- . strategies to manage the spread of covid- have been varied, with many jurisdictions pursuing multiple complementary approaches, often including coordinated sourcing and distribution of protective equipment, reallocation of medical capacity, virus and antibody testing, contact tracing, frequent sanitizing of public facilities, social distancing, mask-wearing, managing congestion in public places by staggering timings and moving activities outdoors, limiting large gatherings, quarantining infected individuals, and minimizing the risk of disease exposure via closures of businesses and schools and broader stay-at-home orders. of these strategies, shutdowns and quarantines have been some of the most accessible, widely used, and hotly debated under covid- . a shutdown-centered approach such as this also has strong historical precedent. in fact, closures and quarantines were some of the only tools available to societies prior to the virology advances of the th and th centuries. though the shutdown of firms has been more comprehensive under covid- than in many past pandemics, the primary measures being taken now, such as quarantining sick individuals, restricting public gatherings, and closing schools, were all implemented during the pandemic (markel et al., ; hatchett et al., ) , albeit with a smaller scope and shorter duration. likewise, when england was combatting the other countries offer a contrast on one or more of these dimensions. for example, though some of these early gains have since dissipated, taking a more authoritarian and centralized approach, china and india had some initial success in containing the virus following swift and complete lockdowns, underscoring the potential importance of state capacity and centralization in pandemic control. likewise, south korea's response demonstrated the importance of relative novelty: due in part to experience with past respiratory pandemics, pre-existing public health infrastructure and greater public buy-in with mask-wearing allowed them to respond more quickly and effectively to the greater use of firm closures as a disease-control strategy today could be due, for instance, to improvements over time both in the safety net and in remote-work capabilities. this more widespread pause on non-essential activities may in turn lead to fairly different effects of covid- relative to past pandemics, e.g., in terms of patterns of disease transmission or total economic impact. while cities employed a diverse set of non-pharmaceutical interventions (npis) during the pandemic, only a small fraction of these interventions (namely, closures of public facilities, isolation policies, bans on public gatherings, and making influenza a notifiable disease) were widely practiced across localities (hatchett et al., ) . moreover, markel et al. ( ) document that npis were in place for only months or less in out of the cities in their sample; even the maximum duration in their sample ( days, in kansas city, missouri) still falls far short of the u.s.'s experience of covid- npis to date. indeed, barro ( ) suggests that the short average duration of npis during the pandemic led them to be relatively ineffective in curtailing mortality. the efficacy of npis depends on factors including the type of intervention, when it is first implemented, how long it is in place, and the strictness with which it is implemented. because of this, and although npis under covid- have been in place longer than during the pandemic, it is difficult to say at this stage whether this necessarily means that they will have been more effective in reducing morbidity and mortality-particularly because covid- npis in the u.s. have tended to be implemented somewhat late in the pandemic's course, have tended to be intermittent and noncomprehensive, and have tended to be leniently enforced, all factors which undermine efficacy and which may themselves be contributing to the need for longer npi duration. plague in the s, they quarantined ships from other countries, closed ale houses, and limited the number of lodgers allowed in a house, actions that would sound familiar to cruise ship passengers and restaurant owners during the covid- pandemic (bell, ) . indeed, it is striking-maybe even alarming-how little has changed about our best options for fighting pandemics, despite centuries of advances in medicine, public health, and living standards. this policy response, necessitated by factors including inadequate testing and broader uncertainty about key epidemiological parameters-even those as basic as precisely how and through whom the disease can be transmitted, and whether it is possible to become re-infected-makes the economic history of policy responses to pandemics particularly relevant for studying the current crisis. even when we contemplate a world where successful covid- vaccines are available, history sounds a note of caution: the same underlying issues that have made mask-wearing both incomplete and fraught in settings, like the u.s., with a strong institutional commitment to liberty and rugged individualism, could also be expected in the context of covid- vaccination. as troesken ( ) notes, anti-vaccinationism has a long history in the u.s., bolstered by the common failure to appreciate the extent of infectiousdisease externalities (the choice not to vaccinate can be individually rational, even if people understood externalities, which they largely do not), as well as by a belief in both minority rights (individuals cannot be forced to vaccinate) and federalism (individuals preferring not to vaccinate can sort into amenable jurisdictions). while troesken documents that mandatory vaccination was frequently enforced in the past via fines, or by denying access to schools or other public services, it is difficult based on the nature of the u.s. covid- response to date to imagine such enforcement mechanisms being implemented. instead, in heterogeneous, strongly pro-individual, pro-freedom societies, we may need to rely on a stylized fact that troesken demonstrates using data from th century smallpox epidemics in germany: vaccinations rates rise in pandemic years, because during pandemics, the risk of infection rises sharply, and the private costs of non-vaccination are clearly outweighed by the private benefits. for thinking about the direct effects of pandemics on the health and wellbeing of individuals in the shortand long-run, the influenza pandemic, or the -spanish flu,‖ provides a useful point of reference. covid- to date parallels the pandemic in several key ways, including its rate of transmission, global spread, and crude mortality rates. the spanish flu was one of the most acute and widespread natural disasters in modern history. taubenberger & morens ( ) estimate that during the pandemic, roughly million individuals, equivalent to roughly a third of the world's population at the time, were infected and symptomatic. case fatality rates, at over . percent, were at least times as high as in other influenza pandemics, making the virus especially lethal. all told, somewhere between and million individuals perished globally. the death toll in the u.s. alone exceeded that from all american combat deaths over the twentieth century (almond, ) . see for example markel et al. ( ) on the effectiveness of school closures in combatting the spread of the influenza pandemic, meyers and thomasson ( ) on the effects of polio-related school closures on educational attainment, and alfani & murphy ( ) on city-level quarantines during pre-modern plagues. cultural features like distrust of scientific expertise, and of institutions more generally, may also undermine vaccine compliance. troesken ( ) notes that the underlying legal theory behind vaccination non-compliance fines gained further credence after the supreme court upheld the affordable care act's insurance mandate in national federation of independent business v. sebelius, u.s. ( ). there are challenges to drawing lessons from the pandemic. much remains unknown about the origins and epidemiology of the virus and its economic impacts are confounded by the effect of world war i. the pandemic itself was sharp, sudden, and concentrated over the span of little more than a -month period. the virus, an h n strain similar to that which caused the swine flu outbreak, spread roughly simultaneously across europe, asia, and north america, in three distinct waves over the year beginning in spring . the first of these waves, appearing in march , was relatively mild. it was followed by a substantially more catastrophic one from september to november , and another in the early months of (taubenberger & morens, ) . in some parts of the world, particularly in east asia, a further major wave of pandemic influenza hit as late as (lin & liu, ; ogasawara, ) . this sort of timing and spacing was unprecedented among influenza pandemics, as was its distinctive mortality profile. where influenza death rates by age typically follow a u-shape, with high mortality rates among the very young and the very old (as is also the case with the sars-cov- , the virus behind covid- ), the strain followed a w-shape, with a sharp peak in mortality risk among young adults as well. indeed, almost half of all influenza-related deaths during the pandemic period accrued to those aged - (taubenberger & morens, ) . the age pattern associated with this strain of influenza was in fact so unusual that it has been exploited as a diagnostic tool in recent studies. for instance, while the influenza pandemic is typically thought to have emerged in full force in europe around the summer of , and in a milder form somewhere in the central u.s. in spring , detailed age-by-month mortality statistics allow olson et al. ( ) to uncover evidence that an early -herald‖ wave of pandemic influenza was actually present in new york city well beforehand, from february to april of . during this period, the age profile of excess influenza mortality had started to shift from the older ages typical of interpandemic seasons to the younger ages that characterize pandemic seasons. this underscores the value of accurate and disaggregated data in tracing the origins and spatiotemporal spread of pandemics, and the need to strengthen not only rapid-response public health infrastructure, but also that to support ongoing disease surveillance. turning to morbidity, those under the age of , and particularly, those aged - , had disproportionately high incidence of influenza-however, the latter group had a much lower death rate from influenza and pneumonia than other ages, further sharpening the middle peak in the morbidity-adjusted pandemic mortality curve (taubenberger & morens, ) . age, however, was not the only major factor that contributed to pandemic mortality risk, and a range of recent studies have emerged cataloging the often interrelated features of countries, cities, and individuals that led to disparities in the immediate mortality burden of the flu. on these mechanisms, the evidence is mixed-surely in part because of diverse empirical settings and disciplinary approaches-but certain patterns do emerge. first, baseline health status mattered: both pre-pandemic pneumonia, a bacterial condition with a strong biological interaction with the influenza virus, and infant mortality rates, a proxy for population health, contributed to higher pandemic flu mortality (acuna-soto et al., ; clay et al., ) . likewise, high levels of air pollution, an environmental factor that aggravates respiratory conditions and depresses baseline health, also raised pandemic mortality. for instance, clay et al. ( ) examine evidence from a panel of u.s. cities, and find that the air pollution generated by coal-fired electricity plants was a significant contributor to pandemic mortality, with effect sizes roughly half those associated with measures of population health and poverty. together, they estimate that these factors accounted for approximately half of all cross-city variation in pandemic mortality. in another study, they find that both infant and all-age mortality were impacted adversely by the presence of coal-burning plants, with poor air quality responsible for - percent of total pandemic mortality in high-and medium-pollution cities, a figure equivalent to some , - , excess deaths beyond those attributable to the pandemic alone (clay et al., ) . , second, population density and related concerns, such as housing quality and the number and composition of social interactions, were also important factors in pandemic mortality. in europe as in the u.s., the pandemic came to cities earlier, and was more devastating there, a phenomenon linked to urbanization and residential crowding (chowell et al., ; mamelund, ; murray et al., ) . transmission was localized, and influenza and pneumonia mortality exhibited significant and rather tight (e.g., - , m) spatiotemporal clustering (grantz et al., a,b; tuckel et al. ) , though proximity to high-risk population centers like wwi military bases appears to have had little effect (clay et al., ) . although urban centers were associated with higher pandemic mortality, the opposite population gradient prevailed when comparing among cities, or among rural areas: in both cases, smaller, less dense localities fared worse (acuna-soto et al., ; chowell et al., ) , suggestive perhaps of capacity constraints in the healthcare workforce and medical infrastructure. third, factors-such as illiteracy and foreign-born status-that might have prevented individuals from adopting public health recommendations were strong predictors of elevated mortality, often above and beyond their association with poverty. higher rates of illiteracy were linked to higher rates of influenza mortality during the pandemic, across both cities and neighborhoods (clay et al., ; grantz et al., a, b) . likewise, foreign-born status not only predicted higher pandemic mortality in hartford, connecticut, but the relationship between nativity and mortality persisted even after controlling for socioeconomic status, population density, and neighborhood ethnic composition, indicating perhaps a role for social factors, or language or cultural barriers to the adoption of relevant public health measures (tuckel et al., ) . crucially, the consequences of these barriers were not limited to the foreign-born: holding all else equal, native-born individuals living in areas with a higher share of foreign-born had higher mortality rates than their counterparts living alongside a lower share of foreign-born neighbors. this emphasizes the importance of neighborhood spillovers in infectious disease transmission-and, of course, demonstrates the interrelated nature of individual-and neighborhood-level mechanisms. it is possible that indoor pollution and seasonality also played a role in air quality-influenza interactions, both during and outside pandemic times. for instance, influenza is generally prevalent in the winter, a time when coal smoke from home heating also tended to peak in this era (barreca et al., ) . clay et al.'s ( ) observation that modern levels of pollution in parts of the developing world, including india and china, are on par with those in the early th century u.s., sounds an ominous note in light of the current crisis-though the circumstances today (e.g., improved medical technology, the higher baseline share of trafficrelated emissions, a fall in pollution due to widespread economic shutdowns) may be just different enough to ameliorate concerns over the lethal interaction between pollution and pandemic influenza. while pollution can lower baseline health by undermining the respiratory system, it is worth noting that pollution may also be associated with higher baseline health, insofar as it proxies economic activity. for instance, clay et al. ( ) find evidence of crucial tradeoffs between the income generated through industrial activity on the one hand, and the pollution generated on the other in the u.s. from the s to the s. in less developed localities, infant mortality followed a u-shaped pattern with respect to the expansion of coal capacity: first falling as rising incomes and cleaner residential energy sources buoyed infant health, and then rising as subsistence health needs were met and the concentration of pollution grew. the net health effects of a pandemic that dampens economic activity (and so reduces pollution), then, is therefore likely to be context-specific, depending on factors such as the level of baseline health and income, the extent of medical infrastructure, and the strength of social safety nets. troesken ( ) also points to individualism and liberty as cultural/institutional values that tend to lower individual-level compliance with public health recommendations. when considering these biological, demographic, and socioeconomic factors in quick succession, it is difficult not to see the overarching hand of income in all of these mechanisms-though, to be clear, several of these studies are careful to disentangle these factors from their association with income. in theory, income gradients in pandemic mortality could arise through a number of channels, including many of those hinted at above: e.g., the tendency of those with higher incomes to have better baseline health status, rendering them biologically less vulnerable and more resilient to infection; higher-quality and lower-density housing, reducing the chances of viral transmission; better public health knowledge, the human capital necessary for individuals to effectively assimilate this knowledge and to adopt life-saving recommendations, and timelier and more robust public health interventions, all slowing the spread of illness; better access to healthcare and medical infrastructure, improving the probability of survival conditional on infection; and a greater capacity for individuals to undertake avoidant, adaptive, and compensatory behaviors, both throughout and following the pandemic. crucially, these channels can operate at both individual and institutional (e.g., city or country) levels, with both richer people and localities-and certainly, the interaction of these-theoretically better equipped to weather the crisis. the fact that some of these channels are highly correlated, of course, can make it difficult to pinpoint the underlying mechanisms: higher-socioeconomic status (ses) individuals are likelier to be both healthier, protecting them from infection, and more educated, rendering them better able to adopt public health measures; cities tend to be richer in both income and infrastructure, but they are also more heterogeneous and densely populated than rural areas. nevertheless, the literature can still shed light on the role of income on net. while some studies explicitly looking at its role in pandemic severity have shown little relationship between pre- economic development and pandemic mortality (brainerd & siegler, ) , a great many indicate that poverty exacerbated mortality risk. for instance, murray et al. ( ) document tremendous (i.e., over thirty-fold) within-and cross-country variation in excess mortality due to the pandemic, with nearly half of this variation explained by baseline per capita income. taking a finer-grained look at these issues, grantz et al. ( a,b) explore the socioeconomic determinants of pandemic mortality and transmissibility using detailed data from chicago. among the associations they find between health and various poverty proxies are large, statistically significant, and negative associations between census tract-level homeownership rates and mortality. these findings are consistent with the lower baseline health of lower-ses neighborhoods, their poorer access to medical care, and their lower awareness and adoption of public health recommendations. shanks & brundage ( ) add that these factors may be proxying other features of low-ses populations, such as a higher risk of sequential infections (e.g., pandemic influenza followed by a secondary bacterial infection such as pneumonia), or the larger number and lower-ses composition of their social interactions. all of these could have contributed to higher cumulative pandemic mortality through faster and more widespread disease transmission, higher incidence of infection, or higher case fatality rates. these results suggest that rather than acting as a democratizing force, the pandemic further entrenched preexisting socioeconomic disparities. the clear implication of studies documenting the immediate health effects of the outbreak is that the damage from pandemics has, and remains likely to, fall disproportionately on disadvantaged communities. apart from its effects on health, however, the pandemic also had important consequences for population dynamics. one such effect pertains to temporal and cross-disease mortality spillovers resulting from pandemic-era mortality patterns. noymer ( ) shows that the influenza pandemic hastened the decline of tuberculosis in the u.s. through a harvesting mechanism. specifically, he suggests that independent competing risks may be responsible for this phenomenon, driven by substantial age overlap in the profile of prospective tuberculosis and (pandemic-type) influenza victims. this -passive selection‖ contrasts with -active selection‖ based on biological interactions between influenza and tuberculosis. this harvesting, in turn, had long-lived implications for sex differences in post-pandemic mortality rates: because tuberculosis morbidity disproportionately affects men, and because the influenza pandemic reduced the pool of those who might die of tuberculosis in the years following, the pandemic had the effect of eroding women's longevity advantage over men. we might expect similar outcomes in the context of covid- given that a large share of those dying have one or more co-morbidities, though the distinct age profile of pandemic deaths versus covid- deaths may complicate these dynamics. studying brazil, guimbeau et al. ( ) likewise find rather larger reductions in sex ratios at birth following the influenza pandemic, consistent with the greater vulnerability of male fetuses to adverse in utero shocks-a phenomenon often seen in the literature on famines and environmental disasters. such changes in the sex ratio, or in sex-specific survival, may well have had long-run implications for marriage and labor markets. another major area in which the pandemic affected demographic behavior relates to marriage and fertility. in some cases, this was largely a function of pandemic psychology. mamelund ( ) shows that a climate of fear and uncertainty in norway, alongside social distancing efforts and peculiarities of norwegian marriage laws (which imposed a one-year waiting period before widows could remarry), led to a drop in births in , as families deferred childbearing. higher rates of maternal mortality and miscarriage during the pandemic likely also contributed to a drop in birth rates. this pent-up demand for children (alongside -replacement‖ demand for children lost to the pandemic) was released after the crisis passed, resulting in a baby boom in . elsewhere, as was the case in nearby sweden, changes in fertility arose from the way that pandemic mortality affected markets for marriage and labor: boberg-fazlić et al. ( ) find evidence of a drop in fertility during the pandemic, followed by a short-lived rebound in post-pandemic fertility. the net effect in the long term, however, was to reduce fertility-due in part to persistent disruptions to marriage markets (particularly in rural areas and poorer cities); the adverse effects on income; as well as to behavioral changes induced by the pandemic, including a rise in female labor supply (and so, an increase in the opportunity cost of childrearing) in regions with high male pandemic mortality rates. perhaps most noteworthy, the short-run post-pandemic fertility increase was selective in nature: a child born during this boom was more likely born to mothers who were married or who were high-ses city-dwellers. this was largely driven by postponement fertility, and particularly, selective postponement. finally, pandemic-related mortality affected childbearing through its effect on survivors' incomes. donaldson and keniston ( ) show that the high pandemic death toll in some regions of india implied a substantial increase in per capita incomes, as survivors assumed the agricultural land of pandemic victims. in light of this rise in incomes, they find an increase in both the quantity and quality (given by literacy and height) of children born following the pandemic in india. phenomena such as these, which change the sex-and age-composition of the population-not to mention the average health status of successive cohorts-are likely to have long-lived effects on economic development, population health, and individual wellbeing. the lethality and peculiar age profile of the pandemic also give rise to long-run considerations. these may be especially relevant in light of covid- , where the vast majority of people who become sick ultimately survive. during the pandemic, young adults-including prime childbearing-age womenwere some of the likeliest to fall ill: in some parts of the u.s., roughly a third of all mothers (relative the about percent of the general population) became infected during the crisis (almond, ) . moreover, across settings, evidence of replacement fertility is rather more limited. note however that covid- appears to be less prevalent, and possibly less severe, among prime-aged people. consequently, it is possible that scarring through the health channel under covid- may end up being less severe, and/or less widespread, than that following the influenza pandemic. scarring through the income/labor-market channel, however (explored in more detail in section iv), could well be substantially worse following covid- than the pandemic, given the latter's relatively mild and short-lived effects on the economy. despite the very high mortality rates from this pandemic, most of those infected ultimately survived. this left considerable scope for maternal morbidity-and, through the impact of maternal stress and illness on intrauterine hormones, nutritional resources, and other factors-for insults to fetal health. in what is perhaps the seminal study in economics of the influenza pandemic's long-run effects on wellbeing, almond ( ) finds wide-ranging adverse effects on later-life human capital and labor market outcomes among u.s. cohorts exposed to the pandemic in utero. these include substantial reductions in high school completion rates, wages, and socioeconomic status, alongside large increases in the probability of living in poverty, the receipt of welfare payments, the likelihood of incarceration, andparticularly among men-the probability of physical disability. that these adverse outcomes exist in spite of a pandemic-induced increase in miscarriages, stillbirths, and infant mortality rates (see, e.g., guimbeau et al., ; mamelund, )-all culling forces which likely resulted in a pool of survivors if anything positively selected on health-is a testament to the catastrophic extent of post- scarring. almond's initial study has also since spawned a large and varied literature interrogating the long-run effects of the pandemic across a range of global settings. a first set of studies dig deeper into the u.s. case. one such study shows that birth cohorts (and in particular, those born in quarter of , who were in utero at the height of the pandemic), are percentage points (or percent) more likely to report fair or poor health than their counterparts born in surrounding years; see a statistically significant - percent increase in a range of functional limitations, including trouble hearing, speaking, lifting, and walking; and are also likelier to experience diabetes and stroke (almond & mazumdar; . others debate the possibility of pandemic-induced selection into fertility, which could confound estimates of the long-run health effects of early-life pandemic exposure. these studies ultimately conclude that the positive selection of wwi recruits, and the corresponding negative selection of pandemic-era fathers, does not substantially alter the conclusion that fetal exposure to the pandemic was a major and direct cause of these cohorts' later-life disadvantage (brown & thomas, ; beach et al., ) . a newer set of papers, focusing on non-western, and particularly, lower-income, settings, shows that the evidence on the pandemic's long-run penalties is robust across a range of empirical contexts, each with different levels of baseline income and health status, different institutional responses to the pandemic, and different degrees of involvement in wwi. for instance, as in the west, in taiwan there is evidence of permanent scarring: cohorts exposed to the pandemic in utero faced penalties with respect to educational attainment, heights, kidney disease, circulatory and respiratory issues, and diabetes (lin & liu, ) . in low-income settings with minimal public health intervention, even higher incomes only did so much to buffer these shocks: in a sample of high-ses children in japan, ogasawara ( ) finds that in utero exposure to the influenza pandemic reduced boys' and girls' heights by . cm and . cm, respectively-magnitudes which in other studies have been associated with substantial increases in the probability of type ii diabetes, osteoarthritis, and heart disease. the long-run results seen in japan, as in guimbeau et al. ( ) in brazil, are consistent with sex differences in resilience to adverse health shocks. now quite common and influential in economic research, the conceptual framework linking early-life conditions to later-life health and wellbeing is termed the -barker‖ or -fetal origins‖ hypothesis. this hypothesis holds that certain chronic conditions stem from deficits in the fetal environment (barker, ) . based on this initial literature in epidemiology and medicine, which focused on evidence from historical famines, a growing literature in economics has used these ideas to model the technology of human capital formation, and to identify sensitive and critical periods for the development of a range of outcomes contributing to labor market success and general wellbeing, including cognitive and non-cognitive skills, metabolism, and longevity (heckman, ; almond & currie, ) . meanwhile, swedish pandemic survivors saw reductions in life expectancy (helgertz & bengtsson, ) . the reduction in the health, human capital, and labor market prospects of cohorts exposed in utero also appears to have dampened their marriage market prospects in ways that continue to carry intergenerational consequences. while both men's and women's own educational attainment was lower among exposed cohorts, only exposed women appear to suffer a marriage market penalty: they marry earlier, to spouses with lower levels of education (fletcher, ) . these are factors generally understood to reduce household incomes, female control of household resources, and the budget share allocated to child-centric expenditure. as such, these effects could represent a mechanism-alongside, e.g., epigenetics, or the more direct role of parental education in facilitating children's access to quality healthcare and schooling-by which we see intergenerational persistence in the consequences of early-life exposure to the influenza pandemic of . indeed, moderate adverse effects on educational attainment, occupational prestige, and family socioeconomic status have been documented up to the third generation, i.e., the grandchildren of those exposed in utero (cook et al. ) . what action, if any, did households take to shield their children from these effects, or to help them recover? while surprisingly little has been written in the context of the pandemic on questions of individual-and household-level avoidance, adaptation, and remediation, parman ( ) is a noteworthy exception. drawing on linked microdata from the u.s., he finds evidence of reinforcing investments in response to the influenza pandemic: that is, families with a child in utero during the crisis shifted resources to the child's older siblings, leading the latter children to higher educational attainment. parman explicitly rules out changes in family size, birth spacing, or selectivity in any such changes, underscoring that the effects observed here are directly a function of parents reallocating limited resources away from affected children, and toward the child with a higher human capital endowment at birth. thus, household responses may have if anything compounded any early-life disadvantage associated with the shock. historical pandemics can help us think about potential long-run effects on wellbeing arising directly through the current pandemic's patterns of morbidity and mortality. but what about the impacts resulting from its disruption of daily economic life? one of the central features of the current coronavirus pandemic is the sudden, extreme, and widespread economic disruption it has caused. on this count, it has perhaps less in common with other recent pandemics. indeed, the immediate economic disruption caused by the pandemic pales in comparison to that caused by so, while this historical pandemic can some work has, however, addressed the broader policy responses (and lack thereof) to the pandemic in the u.s. for instance, hatchett et al. ( ) find that cities that simultaneously implemented multiple non-pharmaceutical interventions (consisting of, e.g., isolation of sick individuals, bans on public gatherings, mandatory notification of disease, and closure of public gathering places, staggered business hours, and no-crowding rules) early in the pandemic had peak mortality rates roughly half that of cities that did not implement such interventions, and substantially lesssteep epidemic curves. no single intervention was responsible for these gains; rather, it was the combination of multiple mutually reinforcing interventions that were effective. these findings are in line with markel et al. ( ) , who emphasize the importance of early and sustained non-pharmaceutical interventions during the pandemic. while many cities were successful in taking such a multi-pronged approach to pandemic management, on the whole the u.s. policy response to the pandemic was rather weak, undermined by a preoccupation with world war i-related efforts. until the covid- crisis, there had been relatively little work on the effects of the pandemic on economic activity, largely for lack of high-frequency, spatially disaggregated data on local economic conditions (see beach et al. (forthcoming) for an excellent overview of both the state of this literature and related empirical challenges). indeed, the precise magnitude and temporal reach of these economic effects are still being debated (see, e.g., basco et al. ( ) , barro et al. ( ) , correia et al. ( ) , lilley et al. ( ) , and velde ( )), and a challenge for many of these studies in identifying pandemic effects on the economy remains the confounding effect of world war give us insight into long-run effects on wellbeing through the health channel (-direct‖ effects), we must look elsewhere to think about the long-run consequences of pandemics through corresponding economic downturns (-indirect‖ effects). but where to look for a suitable comparison? in some ways, episodes such as the black death or the aids crisis in sub-saharan africa would seem to present closer analogues than the influenza pandemic, as health events with massive and lasting economic ramifications. the catastrophic loss of life under these pandemics fundamentally reshaped entire societies and economies, with, for instance, the resulting labor scarcity driving up the real wages of survivors, and, in some cases, precipitating other major demographic, economic, social, cultural, and institutional changes (young, ; alfani & murphy, ) . indeed, some point to the former plague as a major contributor to sustained rises in western european living standards even under a malthusian regime (voigtländer & voth, , a , and to the region's rapid economic development and eventual divergence from the rest of the world over the early modern period (clark, ) . notes: the insured unemployment rate is based on employees covered under unemployment insurance as reported to states by employers. covid- cases are relative to the entire state population. unemployment data were retrieved from https://oui.doleta.gov/unemploy/claims.asp. covid- data were retrieved from https://github.com/nytimes/covid- -data. the code and data needed to generate the figure are available at open-icpsr (https://doi.org/ . /e v ). in each of these pandemics, mass mortality led to rapid and dramatic changes in population density and age i. moreover, it is worth noting that the -focused studies that have emerged in the wake of covid- tend to conflate the economic effects of the pandemic that arise from within and outside the -direct health-shock‖ channel. to disentangle these channels and use a shock of comparable magnitude, we focus primarily on the great depression when examining the long-run human effects of economic dislocation. see alfani & murphy ( ) for an excellent and in-depth review of the literature on pre-industrial plagues, their long-run socioeconomic consequences, and parallels to modern pandemic control efforts. structure, which in turn affected factor prices and labor markets. thankfully, mortality rates under covid- are not on such a scale as to produce the sort of fallout seen with these events. instead, it appears it may be a combination of factors other than the virus's actual toll on morbidity and mortality that is the source of economic dislocation in this instance. indeed, as figure shows, the severity of the immediate health effects has not been a clear predictor of a locality's economic downturn. likewise, emerging evidence complicates the popular conception that pandemic-control measures themselves, such as stay-at-home orders, are primarily responsible for the downturn associated with covid- . for instance, while gupta et al. ( ) suggest that % of the decline in employment in the early months of the pandemic was driven by state and local social distancing policies, kahn et al. ( ) show that the labor market effects of covid- to date have been broader-based than is typically thought. all u.s. states exhibited a collapse in job vacancies in march , and a corresponding rise in unemployment insurance (ui) claims, irrespective of either the intensity of the virus's initial spread or the timing of stay-at-home orders. these phenomena were seen for the most part across both essential and non-essential sectors, directly-and indirectly-affected sectors, and across occupations with and without work-from-home capabilities. they conclude that -the current damage done to the economy is not solely caused by the stay-at-home orders; it is too large and pervasive.‖ exploring the drivers of the collapse in economic activity, goolsbee & syverson ( ) suggest that -individual choices were far more important [than government restrictions,] and seem tied to fears of infection.‖ these voluntary disease-avoidance strategies by individuals are likely connected to the lack of decisive and coordinated policy responses, and to broader uncertainty about this novel disease. it remains to be seen whether other plausible mechanisms may also have a role-e.g., global supply chains that allow covid-related firm slowdowns in one country or sector to propagate to others, or changes in firm production decisions under covid uncertainty. clearly, both the current crisis and our understanding of it are still rapidly evolving. what we do know, however, is that the downturn this pandemic has precipitated is substantially larger than in other modern pandemics, and unlike in some pre-modern plagues, is likely unrelated to either mortality-related changes in demography or to immediate reductions in labor supply or work capacity due to contemporaneous morbidity. as such, crises of primarily economic origin, such as historical recessions-and in particular, the great depression-may make the best analogues: while the coronavirus pandemic is a public health crisis, to be sure, it has manifested above all as a massive economic disruption, both in terms of magnitude and reach. accordingly, we might want to think about its health and human capital consequences through this -livelihoods‖ channel as well. indeed, it is these effects that are likely to be most relevant to our current situation. beginning with short-term effects, we can look to a large literature on business cycles and health. these studies indicate that the net effects of downturns on morbidity and mortality will likely be highly contextdependent. this is because health is multidimensional, there are many countervailing channels through which local economic conditions can affect wellbeing, and because the particulars of the empirical even while modern globalization has made disease transmission faster and harder to control, and even while increased efficiency in healthcare systems and global supply chains have complicated efforts to quickly ramp up treatment and control responses, other modern factors have made the current pandemic less dangerous to health than those that came before it-among them, improved medical technology, which has made it easier to manage secondary infections, and higher incomes, which have made human populations both less vulnerable and more resilient to infectious disease. this is certainly true at least in a distributional sense. while adverse effects will certainly be severe through direct morbidity/mortality channels, these will nevertheless be relatively concentrated. for contrast, adverse spillovers from these direct health effects, and from broader disease-control efforts, will be much more diffuse, even if less acute. consider, for instance, that unlike the health-channel scarring effects of pandemics discussed in section iii, the economy-channel shocks apply to everyone to one extent or another, not just those who survive infection. setting-e.g., the size, nature, and origin of the shock; the baseline level of population health; and the strength of social safety nets-will ultimately govern which of these effects dominate (arthi et al., ; cutler et al., ) . recessions have been shown to improve health, for instance, by freeing up time for health-promoting activities such as exercise, childcare, and breastfeeding (dehejia & lleras-muney, ; miller & urdinola, ; ruhm, ) ; by reducing the income available to sustain unhealthy behaviors such as alcohol, tobacco, and drug abuse (ruhm & black, ; ruhm, ) ; by reallocating high-skilled but displaced healthcare workers toward higher-risk populations (stevens et al., ) ; and by limiting individuals' exposure to environmental and work-related hazards, including traffic accidents, on-the-job injuries, and pollution (muller, ; chay & greenstone, ; miller et al., ). meanwhile, adverse income shocks can compromise access to basic needs such as nutrition, medical care, and housing (griffith et al., ; painter, ) ; and can cause psychological stress that in turn raises rates of self-harm and risky behaviors (eliason & storrie, ; sullivan & von wachter, ) . while in theory, the net effect of local economic shocks on health is ambiguous, in practice, the bulk of the evidence drawn from modern and rich-country settings suggests that on net, total mortality rates fall during recessions (arthi et al., ) . in addition to setting-specific features like higher baseline health and stronger safety nets, the fact that beneficial channels tend to dominate in these settings may be in part because this evidence comes principally from small fluctuations in local economic conditions: using cross-country evidence over two centuries, cutler et al. ( ) show that mild downturns lower mortality, while large ones raise it. the downturn caused by covid- would surely qualify as the latter. the evidence is much more mixed in developing-country and historical settings, where levels of baseline income and health are low, where safety nets are weak, and where cutting-edge medical technology is less accessible (see, e.g., baird et al. ( ) and ferreira & schady ( ) ). in such settings, even small losses in income can be devastating to health (costa, ; heckman, ) , and there is less scope for the sort of offsetting positive spillovers and behavioral changes seen in more modern and affluent settings. consequently, this evidence seems to more often indicate countercyclical mortality. for instance, arthi et al. ( a) show that even in the presence of adaptive migratory responses, the cotton famine, a major s downturn in britain's cotton textile-producing regions, substantially raised mortality in cotton regions, particularly amongst the elderly (who were more sensitive to income shocks), amongst cotton households (who faced unemployment and reduced hours), and amongst those working in non-tradeables the case of pollution in particular underscores how complex the interactions between health and the economy can be-all the more so during a respiratory pandemic that has precipitated an economic crisis. tied as pollution is to economic activity, a downturn that reduces pollution (and so reduces direct health hazards) also reduces income (and so raises indirect health hazards). moreover, it does so unevenly across space and demographic groups. add to this long-standing (i.e., baseline) distributional considerations around who is most exposed to environmental and pandemic hazards (see, e.g., chay & greenstone, ; currie et al., ) ; and who, conditional on exposure, is most sensitive to income shocks, environmental shocks, infectious disease shocks, or even all three simultaneously (see, e.g., hsiang et al. ; almond & currie, ) ; and a key question for assessing covid- 's effects through economy-environment interactions then becomes, from both an aggregate and distributional standpoint, whether and for whom the losses in health and human capital through the income channel are offset by the gains in health through actions taken to reduce the spread of influenza, the reduction of pollution, and the interaction of these factors. see arthi et al. ( ) for a much more detailed review. note as well that under covid- stay-at-home orders and supply-chain disruptions, the effects through many of these mechanisms are likely to be much more extreme, since the reduction in economic activity has been much more acute (in some cases, nearly absolute). this is the case even in rich countries, but especially in poor ones. in the latter, as discussed above, even smaller economic fluctuations can raise net mortality. consequently, we might expect developing countries to face the greatest tension between the desire to limit the direct health costs of covid- on the one hand, and the desire to limit those health costs arising from the corresponding economic contraction on the other. this is especially the case if pandemic-control measures are seen as helping the former objective while harming the latter, though it is worth noting that it is still unclear the extent to which pandemic-control measures are responsible for the contraction caused by (whose livelihoods depended on the success of the local cotton industry). diverse historical evidence such as this can help us think about how the effects of the covid- crisis might out play out differently in other economies, particularly in the long run-something we cannot get from modern data, and especially, from modern u.s. data, alone. likewise, turning to the great depression, a more recent and thus perhaps more comparable setting to today's, stuckler et al. ( ) find at best mixed evidence of a beneficial health effect of the downturn: while there was a small reduction in all-cause mortality during this crisis, only those reductions in heart disease (small) and traffic fatalities (rather larger) could plausibly be linked to contemporaneous local economic shocks; other recession-related causes of death identified in the literature, such as suicide, rose substantially. fishback et al. ( ) similarly find that had new deal relief spending not intervened, the great depression would have created a -demographic disaster,‖ depressing birth rates and elevating death rates relative to prior trends (particularly among infants, those perhaps most vulnerable to short-run income fluctuations). their results emphasize the importance of government responses to economic crises that in turn become health crises (and vice-versa): for instance, they note that while all-cause non-infant mortality rates were largely unaffected by relief spending, such income support nevertheless did help reduce rates of certain salient causes of death such as suicide, one of the few causes of adult mortality identified in stuckler et al. ( ) as seeing a marked increase during the great depression. while current debates around covid- are understandably focused on the immediate impact of pandemic-induced recession conditions, the economic history literature teaches us that we should be equally-perhaps even more-concerned about the long-run scarring effects arising from this economic dislocation. indeed, this channel may be especially relevant in more modern, high-income, and robustsafety net settings where most people survive an adverse shock, only to contend with the long-term and sometimes latent fallout. some of these scarring effects stem from the immediate impact on household incomes. depression-era resource deficits have been shown to affect cohorts that were in utero at the time well into adulthood, lowering their college completion rates and later-life incomes, and raising their rates of later-life poverty and disability-adverse effects that were only more pronounced in poorer areas, and areas that received less relief spending (arthi, ; fishback & thomasson, ) . meanwhile, other long-run penalties arise from disruptions to labor markets and human capital acquisition. a large contemporary literature studies the phenomenon of labor market scarring, or the idea that economic conditions at the time of labor market entry may have lasting effects on training decisions, occupational choice, career trajectories, and lifetime income. this evidence, much of it taken from college graduates around the recession, is mixed: some studies suggest that the impact of initial labor market conditions diminishes over the course of an individual's career-often within the first decade-while others find that some penalties associated with early-career shocks can be cumulative and permanent (see rothstein ( ) for an in-depth review; see also, kahn ( ) ). these effects are often heterogeneous by skill level, and may be driven by mismatch in initial job placement (faberman & mazumder , liu et al. , oyer , Şahin et al. , van den berge ), lower initial wages (which may be partially related to job mismatch; the stress of adverse shocks may also be transmitted intergenerationally through epigenetic channels. see, e.g., costa et al. ( ) . likewise, there is evidence that both pandemics and recessions-as traumatic and stressful events-can shape the attitudes and preferences of those exposed during formative years in ways that can have lasting political and economic consequences (see, e.g., campante et al. ( ) ; giuliano & spilimbergo ( ) ; malmendier & nagel ( ); and schoar & zuo ( ) ). while this literature focuses on adverse shocks at the time of labor market entry, note that compared to other recessions, long-run labor market scarring could even extend to a different and younger range of cohorts in the covid- case, because of widespread school closures. other covid- -related mechanisms, such as the loss of parental income, would tend to compound these effects further. oreopoulos et al. ( ) ), reduced working time (cockx & ghirelli ) , and delays in finding employment (genda et al. ) , among other factors. moreover, strategic responses to these shocks, such as migration (feigenbaum ) , temporary exit from the labor force (hershbein ) , and human capital acquisition (charles et al. , barr & turner , may themselves have implications for short-and long-run labor market prospects, as separate from those arising directly from the initial shock. these studies thus strongly suggest that downturns may have important -overhang‖ that may potentially -reduce prosperity for decades to come,‖ both for directly-affected cohorts and the wider economy (rothstein , p. ) . accordingly-and bearing in mind that under covid- , peak unemployment rates for younger workers have been nearly three times the national average -very-long-run and even intergenerational evidence on these issues can be especially valuable. recent work in economic history has looked to the great depression in order to offer precisely this sort of perspective. these studies show substantial and persistent penalties for all workers in severely-hit areas, but especially for new labor market entrants, who faced very different constraints and scope for adaptation than did incumbent workers. moulton ( ) , for instance, finds a substantial earnings penalty amongst less-educated american men just entering the labor market in . while there are large adverse effects for those born in severely-affected states, this age-at-downturn penalty disappears in lessaffected states. likewise, examining evidence on labor force transitions using large-scale linked microdata from the u.s., arthi et al. ( b) show that many younger workers during the depression accepted work that they otherwise might not have considered in better economic times-whether because of their now-dire need, the additional competition from older workers, or some combination of these factors. moreover, many young people seeking work were locked out of the labor market completely by their older counterparts, who now remained in the labor force (or even re-entered it) at higher rates. evidence on occupational transitions and socioeconomic mobility also suggest important career-stage gradients in scarring: younger workers were crowded out of the best local job opportunities by their older counterparts, with young workers in more rural areas pushed out of farming by older workers who retained these jobs at higher rates, and into general laborer and non-occupational positions; and those in more industrial areas being pushed into farming, the less desirable class of occupations in these areas. importantly, while both of these outcomes represent a short-run penalty for newer labor market entrants, the long-run implications for wellbeing may be very different, given the rapid urbanization and the incipient decline of the agricultural sector that was to come. indeed, by providing the impetus to leave agriculture (or by prompting higher rates of out-migration-younger labor market cohorts irrespective of sector were also likelier to have moved across state lines or into urban areas during the depression, perhaps in response to the dearth of local opportunities for inexperienced workers), the great depression may have had a small silver lining for young rural workers. however, at least in the short run, it served to hamper upward mobility-or even, to induce downward mobility. for instance, liu & fishback ( ) show that though concerns over skill depreciation and mismatch during spells of un-or underemployment animated depression-era policymakers, new deal programs largely failed to match workers to jobs that used their skills, often resulting in lower incomes and transitions into lower-skilled employment or unemployment-though at least some general human capital was maintained. meanwhile, feigenbaum ( ) finds that by , intergenerational mobility had fallen for men growing up in cities severely hit by the depression. migration-in particular, the superior destination choices of the sons of richer fathers-was an important mechanism behind these results, again emphasizing the capacity of large adverse shocks to exacerbate rather than level preexisting inequalities. the history of past pandemics and economic downturns provides sobering guidance for what we might expect from the current covid- crisis. there is a complicated relationship between health and economic productivity that will shape the immediate and latent effects of covid- in both obvious and subtle ways. given that these latent effects unfold over decades and even generations, economic history is uniquely capable of providing evidence on the potential long-term costs of the pandemic. experience from both historical pandemics and historical recessions can inform our view of the possible long-run effects of covid- , and how we might mitigate these costs. the experience of the influenza pandemic suggests that disease exposure can impact individuals throughout their lifetimes, both directly through poorer ongoing health, and indirectly through reduced investment in human capital. the costs were not limited to those individuals directly exposed; instead, they spilled over within households and across space, sectors and generations. moreover, while mortality is salient, and the saving of lives remains perhaps the primary objective during a pandemic, avoiding and compensating for morbidity is arguably as important a matter of policy concern, especially in the context of possible long-run effects. particularly in a pandemic where large shares of prime-aged people fall ill (as in the pandemic), or in pandemics where many are infected but ultimately survive (as in both the pandemic and covid- ), experiences of pandemic illness may have lasting effects over the life-course, either through the initial illness (which may, for instance, compromise fetal nutrition, reduce work capacity, or permanently damage health), or through its sequelae later in life. the great depression points to other long-term effects that are likely to emerge from the pandemic-related slowdown in economic activity: both being born or entering the labor market during the great depression led to economic penalties well into adulthood, and constraints on migration had adverse effects on individuals and firms. importantly, history shows us that these two types of harms are mutually reinforcing: damage to health tends to undermine labor market prospects in the long run, while damage to labor market prospects tends to undermine health in the long run. researchers and policymakers should therefore consider the potential for these long-run costs when weighing the short-term costs and benefits of pandemic control and fiscal intervention. history suggests potentially massive future costs for both the economy and the safety net arising from the dampened economic fortunes, chronic health issues, and foregone fertility of cohorts impacted by covid- . given that human capital investments are generally more productive the earlier they are implemented, this suggests that policy interventions undertaken now, such as cash relief, could be especially cost-effective, and their net long-run benefits tremendous. economic history also reveals that we cannot think of the health and economic impacts of covid- independently of one another. past pandemics indicate that regardless of the pathology of a disease, its impacts are often a function of economic conditions. while some pandemics spared no class, many disproportionately impacted individuals of lower socioeconomic status due to a variety of factors including their occupations, living conditions, and access to healthcare. these individuals are at greater risk of exposure, face greater harms conditional on exposure, and are less able to remediate these harms. we have already seen this taking place with covid- , and need to remain aware that the spread of the disease and the severity of its effects will be in part a function of the spatial distribution of residence, economic activity, and environmental harms. these disparate impacts of the virus itself will be compounded by the associated economic downturn. to the extent that the covid- economic downturn limits exposure to environmental and work-related hazards, or reduces spending on unhealthy behaviors, non-coronavirus related dimensions of health may actually improve. however, both the modern literature on developing countries and the u.s.'s experience during the great depression suggest that the severe economic downturn may compound health problems in areas with lower baseline incomes and weaker safety nets. identifying the channels through which income loss and general recession conditions impact health is necessary for properly interpreting any observed changes in population health levels during covid- , and for designing effective policies to safeguard health. successful implementation of these policies also requires a firm understanding of history-roadblocks to public health initiatives during past pandemics associated with institutional structures and individual attitudes offer cautionary tales for our current crisis. while economic history provides useful insights for the current pandemic, the way in which the pandemic is unfolding also provides a fresh perspective with which to revisit the past. we are witnessing the actions that individuals and families, workers and firms, citizens and public officials alike, take to guard against the pandemic, and the damage it has done to the economy. we are witnessing how these responses change as new information on covid- emerges. the current pandemic affords us unprecedently rich and disaggregated data that, even while still evolving, can give new insights into which groups might warrant additional study in past pandemics. all of these dimensions of covid- can help us reshape the roadmap for studying the economic history of pandemics. one of the most important ways the covid- experience can shape the direction of economic history may not be in seeking out the similarities but rather focusing on differences. while the rate of transmission and severity of the effects of covid- have historical analogues, many relevant features of the world are meaningfully different-among them, the global nature of production; flows of people, goods, and information; urbanization; baseline living standards; medical technology; public health infrastructure; and the role of government. these differences can help us understand both past and present pandemics better; moreover, they help us understand how and why things have changed. for example, the covid- shutdowns have been more far-reaching, and the corresponding economic downturn more damaging, than we might have predicted from previous pandemics. can these differences explain the far greater economic costs of covid- relative to similarly lethal pandemics of the th century? this suggests an important direction for future economic history work: identifying why the nature of the response to public health crises differed, and why the resulting economic consequences were often smaller historically. engaging in this work also allows us to grapple with challenging questions about tradeoffs between population health and economic activity. these tradeoffs are incredibly difficult to tackle head on in the face of an unfolding crisis; they force unfathomable but unavoidable choices on policymakers often working with limited information. by offering insight into not just the actions but also the short-and long-run outcomes of governments, firms, and individuals, 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data.‖ federal reserve bank of chicago working paper how the west ‗invented' fertility restriction malthusian dynamism and the rise of europe: make war, not love the three horsemen of riches: plague, war, and urbanization in early modern europe who report on global surveillance of epidemic-prone infectious diseases. world health organization. . covid- strategy update the gift of the dying: the tragedy of aids and the welfare of future african generations key: cord- -c af ip authors: kelly, jaimon t.; allman‐farinelli, margaret; chen, juliana; partridge, stephanie r.; collins, clare; rollo, megan; haslam, rebecca; diversi, tara; campbell, katrina l. title: dietitians australia position statement on telehealth date: - - journal: nutr diet doi: . / - . sha: doc_id: cord_uid: c af ip it is the position of dietitians australia that clients can receive high‐quality and effective dietetic services such as medical nutrition therapy (mnt) delivered via telehealth. outcomes of telehealth‐delivered dietetic consultations are comparable to those delivered in‐person, without requiring higher levels of additional training nor compromising quality of service provision. dietitians australia recommends that policy makers and healthcare funders broaden the recognition for telehealth‐delivered dietetic consultations as a responsive and cost‐effective alternative or complement to traditional in‐person delivery of dietetic services. the successful implementation of telehealth can help to address health and service inequalities, improve access to effective nutrition services, and support people with chronic disease to optimise their diet‐related health and well‐being, regardless of their location, income or literacy level, thereby addressing current inequities. nutrition-related chronic diseases are the leading cause of ill health in australia. within the next years, it is estimated that over % of australian adults will be living with overweight or obesity. one in two australian adults have a chronic disease, with over seven million ( % of the australian population) living with nutrition-related chronic disease, including type diabetes, cardiovascular disease, obesity, diet-related cancer, chronic kidney disease and mental health conditions. , australia, like many developed countries, has an ageing population, which presents a significant challenge for the healthcare system. together these will drive up healthcare expenditure and present a multitude of additional societal, geographical and workforce challenges for the healthcare system to manage. telehealth-delivered nutrition consultations offer a flexible modality to provide effective and cost-effective medical nutrition therapy (mnt), regular monitoring and support to the large numbers of people in the community requiring dietetic services, in particular those with obesity and nutrition-related chronic disease. , according to the world health organisation, the term "telehealth" refers to the remote delivery of health services using information and communication technologies to exchange health information, either synchronously authors are members of the dietitians australia telehealth working group (ie, two-way communication in real time; e.g. telephone and videoconference consultations) and/or asynchronously (ie, one way communication at any time; e.g. text-messaging and web-portals). digital health modalities (encompassing telehealth) also include the remote delivery of nutrition interventions via electronic health (ehealth) modes, such as webbased programs, software programs and a range of mobile health (mhealth) options, such as smartphone applications (apps), text messaging programs and wearable devices. many australians cannot access dietetic services due to economic, geographic and sociographic barriers. there is a high concentration of dietitians located in urban, affluent areas while communities experiencing high rates of people living with overweight and obesity and type diabetes mellitus are located in more disadvantaged urban suburbs and rural areas. furthermore, one in four people with or at risk of chronic disease fail to attend in-person consultations in community-based and outpatient clinics, contributing to substantial healthcare resource waste. some of the major reasons people fail to keep appointments in the community are incurring high indirect costs associated with inclinic consultations (e.g. time away from work, travel and costs of parking), cancellations and re-bookings, and frustrations associated with lengthy waiting times. , innovative health solutions can be used to create proactive, effective and sustainable services to suit growing needs and demands on the healthcare system. while these needs are recognised, historically models of care have fallen short with meeting these needs. in march , the australian government temporarily expanded access to accredited practising dietitians (apd) for medicare benefits schedule (mbs) items to deliver telehealth services to australians with an eligible chronic disease management plan, including videoconference and telephone consultations, in response to the covid- pandemic. these changes have encouraged a reframe of traditional models of healthcare delivery into virtual modalities delivered remotely that can continue well after the immediate covid- crisis. the aim of this position statement is to outline the clinical-and cost-effectiveness of telehealth-delivered dietetic consultations, and to translate this evidence to practice and policy recommendations. this position statement is informed by a review of the existing literature reporting the effectiveness of telephone and videoconference-delivered consultations by dietitians. the literature appraised includes recent systematic reviews where the effect of telehealth-delivered consultations by a dietitian could be defined and compared to either a control group or a face-to-face consultation , - , including cost-modelling studies. [ ] [ ] [ ] further, an updated search (to april ) using the search terms reported in kelly et al screened against additional criteria, including (a) telephone or videoconference diet intervention and (b) delivered by a dietitian. a meta-analysis was performed on selected dietary outcomes. the effect of telehealth-delivered dietetic services is arranged into five sections: (i) weight management for people who are overweight or obese; (ii) chronic disease populations; (iii) malnutrition; (iv) emerging technologies; and (v) cost-effectiveness. there is a growing evidence base supporting the effect of telephone-delivered weight management services for people who are overweight or obese (body mass index (bmi) ≥ kg/m ). two randomised controlled trials (rcts) ( , n = participants ; and , n = participants ) showed that weight loss in people with overweight and obesity is similar regardless of whether the dietetic consultation is delivered by inperson mode, ad-hoc or via telehealth. compared to traditional care, a recent systematic review with meta-analysis ( , n = rcts) concluded that telephone-delivered weight management interventions resulted in a significant decrease in bmi for people with overweight or obesity of − . kg/m ( % ci − . , − . ). recent rcts and other study designs yield additional evidence. an rct ( , n = participants) in people with overweight or obesity, referred by their primary care physician, found that weekly telephone lifestyle counselling by dietitians for months, and second weekly calls for the following months, resulted in significant weight loss. at months, . % of patients in the treatment group had lost % of their body weight vs . % in the control group (p < . ). the treatment group also significantly increased their moderate to vigorous physical activity compared with the control group (+ . minutes vs + . minutes). while weight regain was observed in the months after counselling stopped, physical activity was maintained. telephone-delivered nutrition care is effective for improving dietary behaviour of people with chronic diseases. half of the existing telephone programs published in the literature are conducted in diabetes, and osteoarthritis. telephone-delivered consultations are as effective as inperson consultations in clinic settings. , a -month rct ( , n = participants) focused on improving type diabetes mellitus self-management behaviours, which included nutrition education once a month, led to significant improvements in glycosylated haemoglobin (hba c), cardiovascular disease risk and overall wellbeing compared to in-person delivery. of note, diet quality and reduction in bmi was significant in both the telephone coaching and traditional face-to-face rehabilitation. similarly, a -month rct ( , n = participants) in breast cancer survivors led to a significant improvement in dietary intake of fruits, vegetables, fibre and a reduction in fat intake with a corresponding increase in activity levels and weight loss. in this study, the in-person weight management program was as effective, and both the in-person and telephone coaching arm were more effective compared to traditional care. in an updated search (april , n = rcts) of telephone-delivered dietetic services, a meta-analysis was performed that showed that telephone-delivered consultations by dietitians was a superior intervention compared to traditional care (including those with ad hoc nutrition care) for improving a range of important dietary intake measures, including fruit, vegetable, fibre and fat intake per day (see table ). telephone-delivered consultations also significantly improved physical activity levels, reduced body weight and waist circumference, and improved cardiovascular disease risk compared to traditional care modes (see table ). table summarises the results of the individual meta-analysis performed. combining telephone with one or more other methods of service delivery (eg, face to face; online resources, text messages, videoconferencing) produces similar outcomes to that reported in telephone-only programs. , , , , there is conflicting evidence reported in telephonedelivered dietetic consultations studies for some dietrelated outcomes, including diet quality , , [ ] [ ] [ ] and sodium intake, , , and changes in clinical variables including hba c, , , - blood pressure, , , , , , lipid profiles , [ ] [ ] [ ] , and quality of life. , , larger rcts are needed to confirm the effect of telephonedelivered dietetic consultations for these outcomes. telephone-delivered dietetic counselling has been shown to be an effective method to deliver malnutrition-related care to older adults. malnutrition has been shown to affect up to % of the residential aged care population and up to % of hospitalised older patients. [ ] [ ] [ ] in a systematic review ( , n = rcts), clinical improvements following telephone-delivered consultation cardiovascular disease risk study, participants the cardiovascular disease risk reduced in telephone group, but rose in control patients (d = . ) abbreviations: md, mean difference; smd, standardised mean difference. compared with in-person dietetic care or no intervention included significantly increased protein intake, improved quality of life, and (nonsignificant) trends towards improvements in overall nutrition status, physical function, energy intake, reduced hospital readmission rates and mortality. | videoconference-delivered dietetic services for chronic disease management videoconference modalities to deliver nutrition care are less frequently utilised in the published literature, however, appear to be effective for managing diabetes and obesity. an australian review ( , n = dietetic studies) of videoconference dietetic consultations concluded that these appear to be feasible and well accepted. videoconference-delivered nutrition care is as effective as similar programs conducted in-person. two of the non-rcts included in the review by raven and bywood reported on dietary outcomes, compared inperson vs videoconference methods in people with diabetes and found clinical outcomes to be similar for a group-based program ( , n = participants), and for a multidisciplinary (including a dietitian) individual counselling program ( , n = participants). both these studies reported high levels of patient satisfaction, improvements in diet adherence and enhanced self-efficacy, with improvements found in biomarkers, including hba c, ldl cholesterol and blood pressure. in clients with type diabetes, videoconference interventions to deliver mnt have been shown to be more effective than traditional care (including ad hoc nutrition care), for improving a range of important diet and clinical variables. for example, the ideatel project was an rct ( , n = participants) which provided years of mnt and showed the group receiving videoconference counselling to have significant improvements in diet and exercise knowledge (+ . points compared to the control group). however, while there was significant improvement in waist circumference (by . cm over years) for women, bmi and waist circumference were not significant when males were included in the overall analysis. in the only other identified rct ( , n = participants), people with obesity received weeks of telehealth nutrition coaching (which included combined videoconference and telephone consultations), resulting in significant reductions in body weight (− . kg), waist circumference (− . cm), and energy intake (− kj/day) and improved diet quality (+ points) from baseline. however, the enhanced usual care (which included brief dietitian counselling) also experienced significant improvements in these measures, albeit on a smaller magnitude. therefore, the only difference at follow up was body weight, where % of the intervention group lost % of their body weight, compared to % of the control arm. australian dietitians incorporate ehealth and mhealth technologies into their practice and patient care. , the potential of digital health to support dietitians in the nutrition care process and delivery of nutrition interventions for patients requiring weight and chronic disease management has been outlined previously. in general, patients report high acceptability, feasibility and usability for mhealth interventions targeting chronic disease management, though the technologies and implementation are not without limitations. , positive effects for food and nutrition outcomes have been observed when mhealth modalities are used for treatment and preventative service delivery. systematic reviews report that app-based mhealth interventions can improve dietary behaviours and intake of specific nutrients and foods, such as sodium ( , n = rcts), vegetables, fruit, fast food or takeaway and sugar sweetened beverage intake, as well as snacking behaviours ( , n = studies). another systematic review ( , n = studies) compared mhealth programs to either a nonintervention control or traditional dietary management and concluded that mobile apps and wearable devices are effective tools in facilitating clinically important weight loss of % over the duration of treatment, but these effects were not maintained at to months. however, overall, the evidence was limited due to only three of the studies reporting results compared to a true nonintervention control group. many interventions reported in the literature are multicomponent combining health practitioner counselling with the addition of technology such as text messaging. a metaanalysis ( , n = rcts) delivered via text message demonstrated significantly greater weight loss (− . kg) in the intervention group compared to control. the evidence-base supporting the effectiveness of mhealth technologies in diabetes management is growing. a recent meta-analysis ( , n = studies) showed a mean difference in hba c of − . % ( % ci: − . % to − . ; i = %) in groups receiving smartphone technology consultations compared with control. another review ( , n = rcts) showed favourable glycaemic control regardless of whether the mobile app intervention was delivered by the health professional physically or remotely. in cardiovascular disease specific literature, a systematic review ( , n = studies) of mhealth interventions identified three studies which included diet outcomes found improvements in nutrition knowledge and dietary choice with interventions that were delivered via apps, text messages and web-based platforms. another systematic review ( , n = studies) examined the effects of health interventions on weight loss among patients with cardiovascular disease reporting favourable outcomes for trials using web-based platforms(− . kg; % ci - . to − . ; i = %; n = studies), telemedicine (− . kg; % ci − . to − . ; i = %; n = ) and text messaging (− . kg; % ci − . to − . ; i = %; n = ). telephone-delivered nutrition programs are also costeffective. when compared to the same weight management program delivered face-to-face over months, telehealth-delivered programs were more cost effective ( , n = participants). further, an in-person group-based obesity management rct in rural settings ( , n = ) showed telephone counselling resulted in a lower cost per kilogram weight loss (aud . /kg) vs face-to-face (aud . /kg). an rct ( , n = participants) in a brisbane hospital outpatient setting found individual telephone counselling was more effective than a group based in-person program and the cost per healthy life year gained was aud and aud , for the telephone and group program, respectively. in chronic disease studies specifically, comparing telephone-delivered nutrition consultations to usual care (including those with ad hoc nutrition care), four of five interventions were found to be cost-effective , [ ] [ ] [ ] in people with diabetes, hypertension, chronic kidney disease and people undergoing cardiac rehabilitation. however, the intervention in one of the five studies conducted in osteoarthritis patients was not cost-effective when compared with usual care. for cost-effectiveness of emerging telehealth interventions, a systematic review ( , n = studies) in type diabetes reported mhealth interventions were highly costeffective, with cost per quality adjusted life years (qaly) gained ranging from . % to . % of gdp per capita. the costs varied depending on the number and type of technologies employed that ranged from one technology to three. an existing practice-based evidence in nutrition (pen) knowledge pathway is available for apds, which includes practice points for delivering telephone consultations for adults with chronic disease, non-chronic disease management telephone programs and telephone interventions for improving nutrition outcomes in infants and new mothers. one of these pen knowledge pathways highlights the lack of evidence for call centre support for public health nutrition interventions and government policy implementation, which is due to a lack of evaluation studies in the published literature. however, there are existing telehealth programs with nutrition components in australia, but these are not always specific to dietetic services. for example, since nsw health has offered the community get healthy coaching and information service which provides telephone-delivered coaching sessions over months aiming to improve nutrition, physical activity and, if desired, weight loss. the first evaluation of the service ( , n = participants) revealed significant weight loss of . kg, increased fruit and vegetable intakes and physical activity with decreased intake of take-away meals and sugar sweetened beverages. since then, there have been telephone coaching services offered to different population groups that have been evaluated including aboriginal and torres strait islander people ( , n = participants) showing a significant mean weight loss of . kg, those at risk of type diabetes (mean weight loss of . kg, p < . , n = ), and a pilot program ( , n = participants) in pregnant women to avoid excessive weight gain, showing a nonsignificant difference of . % in the coaching program vs . % in the control meeting recommended weight gain. conceptual models for effective telehealth within chronic disease management have been proposed. success factors in implementing a telehealth model identified by o'cathain and colleagues include ensuring that both the human and technical aspects of telehealth operate well. these implementation considerations are summarised in table s . dietitians australia has highlighted suitable candidates for telehealth dietetic services. these suitable candidates and practical strategies to be considered for optimising telehealth outcomes are also summarised in table s . by considering factors specific to delivery of virtual nutrition care by videoconference, dietitians can use their expertise to deliver services that complement, rather than compete with existing and emerging technologies. issues specific to using videoconference in dietetic service delivery can be addressed through use of a checklist to support them during delivery of mnt in order to facilitate effective and efficient virtual nutrition care. substituting telehealth services for standard consultations covered by mbs item would be cost neutral for the consultation. advice from the department of health is that patients accessing chronic disease management mbs items claim an average . allied health (not dietetic-specific) items per year. expanding access to telehealth-delivered dietetic consultations will result in improved outcomes which would reduce expenditure on medications and decrease hospital costs as demonstrated by the pilot of the diabetes care project. any increase in the number of consultations for dietitians may not require an increase in the health budget but more sophisticated analysis of the current pattern of usage of chronic disease management mbs item numbers to allow modelling of potential changes in its usage. appropriate and effective use of technology within practice is a key competency standard outlined in national competency standards for dietitians in australia. dietitians possess all the skills required to provide mnt using telehealth. taking courses in ehealth either as part of dietetic training, or as continuing professional development for apds, can improve the understanding of concepts essential for using telehealth and ehealth technologies. key components include definitions of ehealth terms and concepts related to telehealth and mhealth technologies; and knowledge and skills related to (i) use of telehealth equipment, (ii) comparison of dietetic consultation components completed in person vs remotely via video call, (iii) quality assessment of mobile apps and (iv) exploration of advantages and disadvantages, and the ethical, security and privacy issues relating to use of ehealth technologies in dietetic practice. this training and professional development in delivery of nutrition and dietetic consultations using telehealth results in improved knowledge, skills and competence in using these technologies. , | future research opportunities there are a number of opportunities for further research concerning telehealth-delivered consultations. specifically, clinical trials are needed to evaluate the implementation of telehealth consultations delivering group-based interventions in populations with chronic disease, and improving access and outcomes for vulnerable populations groups, including those in regional and remote areas through telehealth-delivered consultations. there is also a need to understand the challenges of completing some components of nutrition care via telehealth (e.g. physical measures) and evaluate alternative or modified measures to recommend as suitable proxies. robust economic evaluations are needed across different chronic disease populations and demographics which are most likely to benefit from wider access to dietary services under medicare, including rural/remote areas and house-bound individuals. an economic evaluation should also consider and evaluate the societal benefits of telehealth-delivered consultations that cannot always be captured by typical economic analysis using a healthcare perspetive, , including willingness-to-pay (ie, evaluating the monetary value on the benefit associated with a service, from a societal perspective), and any unintentional consequences that new dietitian delivered telehealth consultations may potentially have (e.g. consequences which may arise from unexpected uptake, creating inequity for populations that may not have access to technology hardware or reliable phone or internet service due to financial disadvantage, which substantially increases costs, unexpected workload changes or other unforeseen factors). finally, it will also become important to evaluate the effectiveness of emerging technologies including mhealth and ehealth nutrition programs alone, in combination with telephone or videoconference programs, or when combined with in-person delivery to reduce the number of counselling sessions required. these evaluations, in addition to addressing the evidence gaps mentioned above, will allow decision makers to make informed, evidence-based decisions on telehealth-delivered dietetic consultations. the summary of results presented in this position statement support the evidence-based recommendations summarised in table . evidence-based recommendations for telehealth-delivered consultations weight management • telephone counselling is effective for management of overweight and obesity in primary care. chronic disease management • telephone and videoconference nutrition consultations improves diet, physical activity levels and reduces body weight in people with chronic conditions. • telephone and videoconference consultations are just as effective as in-person delivered mnt. • telephone counselling is effective for the prevention and management of malnutrition in the community. digital health • digital health solutions (including ehealth (e.g. web platforms) and mhealth (e.g. smartphone applications)) can support traditional in-person or telephone and videoconference delivered nutrition care, but their effectiveness as a delivery modality exclusively requires further research. funding for telehealthdelivered dietetic services • government policy makers and healthcare funders should broaden remuneration benefits for telephone and videoconference-delivered consultations provided by apds, as these are cost-effective and low cost for apds to operate. • expanded telehealth access under medicare and private health payers addresses health and service inequalities, improves access to effective nutrition services, and supports people with chronic conditions to optimise their diet-related health and well-being, regardless of their location, income or literacy level. • mnt delivered via mhealth and ehealth should be considered eligible for medicare or private health rebates when they are used alongside telephone or video conferencing modalities or in-person delivery. abbreviations: apd, accredited practising dietitian; mnt, medical nutrition therapy. australian institute of health welfare. australia's health . australia's health series no. future predictions of body mass index and overweight prevalence in australia primary health care advisory group. primary health care advisory group final report: better outcomes for people with chronic and complex health conditions. australia: department of health, commonwealth of australia expanding access to accredited practising dietitians under medicare. canberra: dietitians association of australia ehealth interventions for the prevention and treatment of 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population telehealth for patients, general practice, primary care and other medical services: a joint media release with professor michael kidd am digital mental health and covid- : using technology today to accelerate the curve on access and quality tomorrow allied health video consultation services interventions to enhance adherence to dietary advice for preventing and managing chronic diseases in adults the effectiveness of telemedicine on body mass index: a systematic review and meta-analysis cost evaluation of providing evidence-based dietetic services for weight management in adults: in-person versus ehealth delivery the breakeven point for implementing telehealth economic evaluation strategies in telehealth: obtaining a more holistic valuation of telehealth interventions equivalent weight loss for weight management programs delivered by phone and clinic comparative effectiveness of weight-loss interventions in clinical practice a randomized clinical trial of a tailored lifestyle intervention for obese, sedentary, primary care patients impact of enhanced (dietitians helping patients care for diabetes) telemedicine randomized controlled trial on diabetes optimal care outcomes in patients with type diabetes telephone-delivered lifestyle support with action planning and motivational interviewing techniques to improve rehabilitation outcomes telephone counseling for physical activity and diet in primary care patients living well with diabetes: -month outcomes from a randomized trial of telephone-delivered weight loss and physical activity intervention to improve glycemic control long-term lifestyle intervention lowers the incidence of stroke impact of a goal setting and decision support telephone coaching intervention on diet, psychosocial, and decision outcomes among people with type diabetes using telehealth to provide diabetes care to patients in rural montana: findings from the promoting realistic individual selfmanagement program telemedicine intervention effects on waist circumference and body mass index in the ideatel project group diabetes education administered through telemedicine: tools used and lessons learned a dietary intervention in urban african americans: results of the "five plus nuts and beans" randomized trial salt and fluid restriction is effective in patients with chronic heart failure coaching patients on achieving cardiovascular health (coach): a multicenter randomized trial in patients with coronary heart disease randomized trial comparing telephone versus in-person weight loss counseling on body composition and circulating biomarkers in women treated for breast cancer: the lifestyle, exercise, and nutrition (lean) study a coaching program to improve dietary intake of patients with ckd: entice-ckd telephone-based weight loss support for patients with knee osteoarthritis: a pragmatic randomised controlled trial feasibility and acceptability of telehealth coaching to promote healthy eating in chronic kidney disease: a mixed-methods process evaluation a pilot randomized controlled trial of a telenutrition weight loss intervention in middle-aged and older men with multiple risk factors for cardiovascular disease a coaching program to improve dietary intake of patients with ckd: entice-ckd setting single or multiple goals for diet and physical activity behaviors improves cardiovascular disease risk factors in adults with type diabetes: a pragmatic pilot randomized trial salt and water restriction is effective in patients with chronic heart failure malnutrition prevalence and nutrition issues in residential aged care facilities recognition by medical and nursing professionals of malnutrition and risk of malnutrition in elderly hospitalised patients nutritional status and length of stay in patients admitted to an acute assessment unit prevalence of malnutrition in adults in queensland public hospitals and residential aged care facilities is telehealth effective in managing malnutrition in community-dwelling older adults? a systematic review and meta-analysis ehealth readiness of dietitians the use of smartphone health apps and other mobile h ealth (mhealth) technologies in dietetic practice: a three country study smartphone apps and the nutrition care process: current perspectives and future considerations mobile health applications in weight management: a systematic literature review impact of mhealth chronic disease management on treatment adherence and patient outcomes: a systematic review application of mobile health technologies aimed at salt reduction: systematic review efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic review efficacy and external validity of electronic and mobile phone-based interventions promoting vegetable intake in young adults: systematic review and meta-analysis frequent nutritional feedback, personalized advice, and behavioral changes: findings from the european food me internetbased rct can mobile technology improve weight loss in overweight adults? a systematic review a systematic review and meta-analysis of interventions for weight management using text messaging effectiveness of smartphone technologies on glycaemic control in patients with type diabetes: systematic review with meta-analysis of trials efficacy of mobile apps to support the care of patients with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials effect of mobile health interventions on the secondary prevention of cardiovascular disease: systematic review and meta-analysis digital health interventions for the prevention of cardiovascular disease: a systematic review and meta-analysis comparing costs of telephone vs face-to-face extended-care programs for the management of obesity in rural settings feasibility, effectiveness and cost-effectiveness of a telephone-based weight loss program delivered via a hospital outpatient setting cost-effectiveness of a population-based lifestyle intervention to promote healthy weight and physical activity in non-attenders of cardiac rehabilitation cost-effectiveness of a telephone-delivered intervention for physical activity and diet a comparison of the cost-effectiveness of two pedometer-based telephone coaching programs for people with cardiac disease economic evaluation of telephone-based weight loss support for patients with knee osteoarthritis: a randomised controlled trial cost and costeffectiveness of mhealth interventions for the prevention and control of type diabetes mellitus: a systematic review practice-based evidence in nutrition (pen) the nsw get healthy information and coaching service: the first five years enhancing the get healthy information and coaching service for aboriginal adults: evaluation of the process and impact of the program telephone based coaching for adults at risk of diabetes: impact of australia's get healthy service piloting a telephone based health coaching program for pregnant women: a mixed methods study telehealth in chronic disease: mixed-methods study to develop the tech conceptual model for intervention design and evaluation dietitians association of australia. telehealth/technology-based clinical consultations video consultations and virtual nutrition care for weight management evaluation report of the diabetes care project dietitians association of australia. national competency standards for dietitians in australia evaluation of the introduction of an e-health skills component for dietetics students. telemed e-health impact of training and integration of apps into dietetic practice on dietitians' self-efficacy with using mobile health apps and patient satisfaction this position paper was commissioned, funded and endorsed by dietitians australia. funding supported the lead author to conduct the literature searches and draft the paper.kc and td are members of the dietitians australia board. neither received any specific funding from dietitians australia throughout this project. key: cord- - wfo yql authors: ammar, walid; kdouh, ola; hammoud, rawan; hamadeh, randa; harb, hilda; ammar, zeina; atun, rifat; christiani, david; zalloua, pierre a title: health system resilience: lebanon and the syrian refugee crisis date: - - journal: journal of global health doi: . /jogh. . sha: doc_id: cord_uid: wfo yql background: between and , the lebanese population increased by % due to the influx of syrian refugees. while a sudden increase of such magnitude represents a shock to the health system, threatening the continuity of service delivery and destabilizing governance, it also offers a unique opportunity to study resilience of a health system amidst ongoing crisis. methods: we conceptualized resilience as the capacity of a health system to absorb internal or external shocks (for example prevent or contain disease outbreaks and maintain functional health institutions) while sustaining achievements. we explored factors contributing to the resilience of the lebanese health system, including networking with stakeholders, diversification of the health system, adequate infrastructure and health human resources, a comprehensive communicable disease response and the integration of the refugees within the health system. results: in studying the case of lebanon we used input–process–output–outcome approach to assess the resilience of the lebanese health system. this approach provided us with a holistic view of the health system, as it captured not only the sustained and improved outcomes, but also the inputs and processes leading to them. conclusion: our study indicates that the lebanese health system was resilient as its institutions sustained their performance during the crisis and even improved. across lebanon in houses among the lebanese population, while % is residing in informal tented settlements [ ] . the unprecedented influx of refugees has placed a considerable burden on the lebanese government, society and economy, which are facing many other challenges. for example, while the gross domestic product (gdp) of lebanon grew by % in , it fell sharply to . % in [ ] , constraining the government' s ability to continue financing the expanding population needs in the presence of stagnant economic growth. a refugee crisis of such a large magnitude is a severe shock to the health system, and threatens continuity of service delivery, destabilizing governance and limiting access to care [ ] . to date, however, the lebanese health system (box ) has been able to accommodate and adjust to the refugee crisis [ ] . resilience is the ability of a health system to sustain or improve access to health care services while ensuring longterm sustainability [ , ] . a resilient system has high tolerance to uncertainty and relies on a variety of resources in its response to shocks [ , ] . despite calls for strengthening policy capacity in this important area [ , ] resilience of health systems to external and internal shocks remains understudied [ , ] . lebanon is currently facing an acute crisis [ ] due to an unprecedented influx of refugees from syria with multiple health needs, which has placed a rapid and an unprece-dented demand on the health system [ , ] . the extraordinary situation of the refugee crisis offers a unique setting to study resilience of lebanon's health system to an external shock, combined with internal shocks due to economic and political instability. the aim of this study is to assess the resilience of the lebanese health system in the face of an acute and severe crisis and in the context of political instability. while many conceptual frameworks for resilience exist [ ] there is no unified definition of health system resilience, or an established method to measure it [ ] . one framework offers dimensions to assess the potential of health system resilience to an emerging crisis, but a standardized set of internationally accepted indicators for these dimensions have yet to be developed and tested empirically [ ] . for the purpose of this study, we have used the following working definition of a resilient system: "a resilient system has the capacity to absorb change due to external or internal shocks, maintain original functions and ensure long-term sustainability" [ ] [ ] [ ] [ ] . when studying the resilience of the lebanese health system we drew on insights from studies of health systems that have faced refugee crises -studies which have considered the ability of a health system to maintain service delivery, prevent major outbreaks and sustain improvements in population level outcome indicators including utilization, service coverage, morbidity and mortality rates, as measures of success [ ] [ ] [ ] [ ] . the indicators used in these earlier studies are in line with the definition of resilience we have used. this definition stresses the ability of a system to reorganize and adapt to change while maintaining original functions and ensuring long-term sustainability [ ] [ ] [ ] . the study employs a case study approach and draws on data from multiple sources. we use an input-process-output/outcome model of a health system [ ] , where inputs, processes and outputs measure the capacity of the health system while outcomes measure its performance [ ] . this approach allows for a comprehensive and holistic analysis of the lebanese health system and offers enough flexibility to capture both the contextual characteristics of the system and factors in place during the acute crisis that have affected the health system response and resilience. the study, which took place from january to july , consisted of two main components: a literature review on resilience and how to measure it, and analysis of secondary data to document the impact of the refugee crisis and the health system response in lebanon. for the literature review, we undertook a search using the following databases: ovid medline, the cochrane library, box . lebanese health system -a brief overview the health system in lebanon is a public-private partnership with multiple sources of funding and channels of delivery. almost one half of the population is financially covered by the national social security fund (nssf), an autonomous public establishment or by other governmental (civil servants cooperative and military schemes) or private insurance. all those schemes provide financial coverage with variable patient copays. the non-adherents are entitled to the coverage of the ministry of public health (moph) for secondary and tertiary care at both public and private institutions. palestinian refugees are covered through the united nations relief and work agency for palestinian refugees (unrwa) for their health care services [ ] . although the moph does not cover ambulatory care services, it provides in kind support to a national network of primary health care (phc) centers all over lebanon [ ] . the centers provide consultations with medical specialists at reduced cost, as well as medicines for chronic illness and vaccines funded by the ministry of health [ ] . around % of the primary health care centers in the national network are owned by ngos while % of hospitals belong to the private sector [ ] . the strong presence of the private sector in service delivery has led to an oversupply of hospital beds and technology [ ] . while there is an oversupply of physicians, there is a shortage of nurses [ ] . and health systems evidence. in addition, we searched gray literature databases such as reliefweb, mednar, oais-ter, open doar, prospero and opengrey. local data were obtained from multiple sources, namely the lebanese ministry of public health database which included data on service utilization, human resources, immunization coverage, and epidemiological surveillance. we also used national health accounts data (that uses the system of health accounts . ) and maternal mortality observatory data. the moph information systems and the maternal mortality observatory data sets are designed to incorporate ongoing assessment and reporting related to displaced syrians, including for immunization coverage, disease surveillance and utilization of health services in addition to maternal and child mortality. other sources included statistics from the lebanese ministry of finance, bank of lebanon and the central administration for statistics (cas), un agency publications, world bank assessments, and international and local ngos publications. human resources. the fluctuating pattern in the number of physicians started before the syrian refugee crisis as a result of a mismatch in supply and demand, with persistent oversupply [ ] . by contrast, the number of nurses working in lebanese health system increased steadily and was not affected by the syrian crisis [ ] . the steady rate of increase in number of nurses occurred as a result of deliberate moph policies, such as the establishment of a career path for nurses, financing of training of more nurses by the lebanese university, supporting the bridging between vocational and academic training, and increasing nursing wages in the public sector [ ] . financing. in - , there was no substantial change in patterns of public spending on health, the budget of the moph, and all public funds rose at the same rate of yearly increase as in the preceding years [ , ] . however, throughout the crisis, the levels of funding from international donors were erratic and far below the amounts required to meet the health needs of the refugees. for example, in , less than % of funding requirement was met [ ] , declining in to % of the funding amount needed [ ] . the funds from international donors are managed by united nations (un) agencies and are channeled through different international and local ngos. the moph was not a recipient of these funds but worked with international entities to influence effective application of the funds to priority areas and populations. throughout the crisis, the lebanese health system was able to sustain the level of financing of services at primary-, sec-ondary-and tertiary-care levels. the moph contracts with primary health care centers were maintained. the moph was able to uphold and improve its contracting terms with private hospitals by including performance measures in the contracts to achieve required service volumes at specified quality levels. additionally, all the public funds and private insurance companies continued to provide cover to their respective beneficiaries, notwithstanding delays in reimbursement. despite financial constraints, the moph managed to increase its expenditure on drugs, which helped to effectively meet the higher demand that arose in recent years [ ] . this expenditure of funds to increase expenditure on drugs was coupled with collaboration with different donors in order to direct external funds to priority areas. for syrian refugees, primary care has been partly subsidized by the united nations high commission for refugees (unhcr). however, for secondary care the financial assistance provided by unhcr has been limited to vulnerable groups, and for life-threatening conditions with copayments provided by refugees [ ] . the limited financing of secondary care services has resulted in a major gap in service coverage, however leading to heavy financial burden on refugees seeking secondary and tertiary care services [ ] . governance. at the start of the crisis, there was no clear government policy regarding the displaced syrian population. while the moph began to offer displaced syrians the same immunization schedule and primary health care services offered to lebanese citizens, unhcr and other relief agencies sought to create their own delivery channels and their own mechanism of financing coverage which operated in parallel to the existing health system. the parallel systems established by international agencies led to fragmentation and poor coordination of the health system response to the refugee crisis. in the absence of a clear government policy, the fragmentation of health system governance prompted the moph to call upon international agencies to consider a more integrated approach to planning, financing and service delivery by embedding refugee health care within the national health system. to develop an integrated approach, the moph established a steering committee that includes major international and local partners to guide the response. the steering committee, led by the moph, develops strategic plans and coordination mechanisms and monitors the response [ ] . all partners in the refugee health response including moph, un agencies, international and local non-governmental organisations (ngos) held regular meetings and set up yearly response plans such as the "lebanon crisis response plan". these response plans detailed all funding sources, activities performed and coordination efforts. these plans were regular-ly updated and tracked, and the results were shared in dissemination workshops and on the websites of these partners. the inclusive model of governance, based on participation, transparency and accountability, was critical in mounting an effective emergency response and in creating health system resilience, and in establishing an effective surveillance system (box ). during the crisis, the participation of the private sector and civil society, and networking with different donors, international stakeholders and un agencies was not only important for health system governance but also for the development of multi-sectoral health strategies. examples of successful partnerships included the engagement of the primary health care national network and private hospitals in health care delivery to mount a unified and effective response [ ] . service provision. provision of health care has been sustained at all levels throughout the crisis. primary health care centers and hospitals from both public and private sectors have remained operational. health programmes, such as those for epidemiological surveillance, immunization, medication for chronic illnesses, tuberculosis, hiv/aids and reproductive health, among others, are functioning effectively [ ] . other programs, such as the accreditation of primary health care centers and integration of non-communicable disease management within primary health care, progressed as planned despite the crisis [ ] . nationwide vaccination campaigns for polio and measles have been routinely conducted as needed, and services provided to all those in lebanon irrespective of nationalities [ ] . these immunization campaigns were conducted in accordance with the district physicians, municipalities, civil society and schools. community health workers, including volunteers from universities and schools, participated in the door-to-door immunization campaigns [ ] . additionally, the epidemiological surveillance program was able to sustain and even enhance its functions, including measurement and monitoring disease burden, detecting outbreaks, investigating emerging infections and implementing early warning and response system [ ] . staff trainings were conducted by moph health experts and adequate precautionary measures were taken at airports and seaports against pandemic threats, such as ebola and mers coronavirus [ , ] . in addition to the primary care centers across lebanon that were providing health services for syrians refugees and the public health response, at the hospital level, unhcr contracted with public and private hospitals to provide for registered displaced syrians selected secondary care services, covering % of the fees [ ] . the additional services financed by unhcr enabled the moph to maintain the functioning of existing units to meet the needs of displaced syrian refuges while allocating additional dedicated health workers for those living in informal tented settlements [ ] . health service utilization. since , the number of primary health care centers in the national network as well as the number of beneficiaries steadily rose [ ] . in , the total beneficiaries of the primary health care network exceeded . million, compared to about in [ ] . these beneficiaries include both lebanese and syrian nationals. in , syrian nationals made up around % of the beneficiaries for the primary health care national network [ ] . private and public hospitals continue to deliver quality services. while the moph has sustained its coverage of hospital admissions for uninsured lebanese, admissions for insured lebanese have not been disrupted by the syrian refugee crisis [ ] (figure ) . meanwhile, the proportion of syrian beneficiaries in rafic hariri governmental university hospital has continued to increase from % in to % in (figure ) [ ] . in terms of immunization coverage, vaccination rates for measles and diphtheria, pertussis and tetanus (dpt) are considered important indicators of health system performance [ ] . the vaccination campaigns achieved high vaccination rates for both lebanese and syrian beneficiaries [ ] (figure ) . in response to the rapid rise in demand for human health resources, the moph, in collaboration with unhcr, who and unicef, recruited a limited number of health workers to strengthen its surveillance system and emergency response capability and to cater for the needs of displaced syrians living in the informal tented settlements, in addition to a limited number of administrative employees at central and peripheral levels. a total of new staff was recruited in phc, in dispensaries' and in public hospitals. due to financial constraints, however, this number diminished gradually to by the end of . retention of the remaining staff will largely depend on the evolution of the crisis. embedded in each program of work were a set of monitoring and evaluation tools that made the stretched activities run smoother. each program approached the crisis as if they were dealing with an enlarged population of %. immunization activities, phc services, and secondary care provision were all maintained and effectively expanded while monitoring and maintaining quality standards. to ensure uninterrupted financial coverage, the moph developed and implemented a reform strategy in to rationalize health expenditures targeting the high financial burden on households. this strategy resulted in lower out of pocket expenditures from % in to % in , at the peak of the syrian crisis [ , , ] . [ ] . similarly, the maternal mortality ratio decreased from per live births in to in [ ] [ ] [ ] . child and maternal mortality observatory data confirm the downward trend in these indicators over the recent years [ , , ] . the influx of syrian refugees has increased the risk and exposure to communicable diseases, including those that previously did not exist in lebanon [ ] . communicable diseases, such as polio, measles and waterborne infections, are considered the greatest public health risks in refugee situations [ ] . outbreak prevention and control, therefore, represent an important measure of the resilience of a health system. lebanon effectively managed several outbreaks including for measles. in , the number of reported measles cases was , compared to cases in [ ] . the spread of leishmaniasis, an infection which was previously not noted in lebanon, was also avoided despite the existence of its vector, the sand fly, in north lebanon and the bekaa, and the presence of infected syrians as a human reservoir [ ] . the number of leishmaniasis cases fell substantially between and ( to cases), with only three lebanese citizens contracting the disease during the crisis [ ] . additionally, lebanon was able to stay polio-free despite reemergence of the disease in syria [ ] . the moph ensured that the vaccination campaigns reached the maximum number of children by conducting school field visits, by having an moph vaccination team at every unhcr refugee registration entry point, by coordination with the moph officers at district level, and primary care centers and by providing door-to-door coverage. syrian refugees have also received routine immunizations and other vaccinations, such as polio and measles through the vaccination campaigns spearheaded and coordinated by the moph, unicef and who. as for cholera, and despite it being considered a public health threat in lebanon by who due to the refugee crisis, lebanon was cholera-free from to [ ] . case notification rate of tuberculosis (tb) in lebanon had been declining until . in , the case notification rate increased by %, however [ ] (figure ) . this increase was attributed to a rapid rise in the number of syrian refugees, as only % of notified tb cases was among non-lebanese [ ] . early detection, isolation, and treatment of tb cases in specialized centers and hospitals among the displaced populations prevented an outbreak in host communities [ ] . in , the treatment success rate was %, with one half of the tb cases receiving treatment completely cured [ ] . our findings indicate that the health system in lebanon was able to maintain service delivery for both refugees and lebanese citizens, prevent communicable diseases and sustain improvements in morbidity and mortality levels in the presence of major external and internal shocks, despite relatively limited increase in system inputs. the health system was "able to adapt to change and retain functionality" of governance, financing and service delivery "while maintaining achievements" [ ] [ ] [ ] . as the crisis evolves, the resilience of health care service delivery in lebanon will be continuously monitored, as the health system comes under increasing pressure. the resilience of the lebanese health system could be attributed to four major factors. first, networking with the multitude of partners in the health sector [ ] and the mobilization and support of regional and global partners, were at the core of the response to the syrian refugee crisis. this integrated approach was evident in the refugee response plan that was developed by key actors and implemented by a wide array of service providers, including from the private and public sectors and ngos [ ] . additionally, the lebanese health system was able to draw upon diverse sources of funding and multiple conduits for service delivery. although multiple financing sources and service providers can lead to fragmentation, good governance based on a public private partnership helped to secure a constant stream of funds, primarily through both reallocation of resources and internal resource mobilization, which allowed patients to bypass government bureaucracy and partially compensate for the delayed and scarce international aid. integration and smart dependency achieved in lebanon is a key feature of resilient health systems [ ] . second, adequate infrastructure and sufficient supply of health human resources was vital in absorbing the additional numbers of refugees. resilient health systems have the ability to tap in to excess capacities for an optimal health response during a crisis [ , ] . lebanon, which had a diverse set of providers also had an oversupply of hospital beds and technology that was used to meet the increased demand during the crisis [ , ] . an adequate supply of a committed and responsive workforce is a precondition for resilience [ , ] . in lebanon, the health workforce is well accustomed to crisis situations [ ] . this experience ensured a regular supply of health human resources that catered to both refugee and lebanese populations. third, a comprehensive communicable disease response helped combat outbreaks, a major health priority during a refugee crisis [ ] . the ebola crisis in west africa has highlighted the importance of epidemiological surveillance as part of an "aware" system in outbreak control [ , ] . in lebanon, the primary health care department, along with the epidemiological surveillance unit, played an important role in ensuring effective and ongoing surveillance. widespread immunization campaigns, with augmented community engagement activities, were employed in a timely manner and synchronized with regional levels to achieve high coverage rates. effective immunization coverage, coupled with the early warning and response system, allowed for prevention and control of the spread of communicable diseases. fourth, integration of refugee health care within the national health system, made possible by the settlement of refugees within lebanese communities rather than camps, was also an important factor. although this approach may have been problematic for the host communities, it reduced administrative and set-up costs, and enabled more responsive service delivery. it also shifted the burden to several geographic areas in lebanon and to several different players in the lebanese health system. the benefits of the integrated health system approach over the approach, which creates multiple parallel service delivery and financing systems, have been documented in other refugee crises [ ] . our findings suggest a resilient response by the lebanese health system to the refugee crisis. despite the limited resources and the turmoil caused by the war in syria, lebanon has been able to cope with an unprecedented influx of refugees, maintain improvements in mortality and morbidity outcomes in the country and achieve the mdg targets. our observations in a real empirical setting lead us to suggest a revised definition of resilience of health systems: "resilience is the capacity of a health system to absorb internal and external shocks, and maintain functional health institutions while sustaining achievements." we believe that this revised definition describes a real life and tested experience of resilience in an unprecedented setting. we identified four major factors that enabled resilience: (i) networking with stakeholders (ii) diversification of the health system that provided for adequate infrastructure and health human resources (iii) a comprehensive communicable disease response and (iv) the integration of refugees into the health system. a question that remains unanswered is the longer-term sustainability of the current response. although, thus far, lebanon has sustained achievements in morbidity and mortality levels, the magnitude and the chronic nature of the crisis continues to pose a threat to the health system. the study has three main strengths. first, to our knowledge, this is the first study to investigate the resilience of a health system during an ongoing major refugee crisis. sec-ond, the use of the input-process-output-outcome model to analyze the data and to categorize the health system resilience has helped to frame the system as a whole, and shed light on the possible contributing factors to achieving resilience. third, the study used multiple sources of information, including the public, private, civil society and humanitarian sectors, to provide a comprehensive view of the lebanese health system. several limitations are also acknowledged. first, the literature lacks a rigorous and scientifically validated method for measuring and proving resilience in health systems. we used a model that included several dimensions of resilience identified from published and gray literature, in addition to health system performance indicators which we considered to be important measures relating to resilience. second, the study was limited by the availability of data on the dispersed refugee population and the ongoing influx of refugees. third, the dynamic nature of the refugee situation means data need to be regularly updated. notwithstanding limitations, however, our study contributes to an area of global importance and helps empirically to illuminate effective response from a health system that has shown resilience in spite of the most severe refugee crisis of recent times experienced anywhere in the world. ministry of public health l. statistical bulletins of the ministry of public health health beyond politics. world health organization eastern mediterranean regional office. lebanon: ministry of public health syria regional response plan -midyear update unchr. regional public health and nutrition strategy for syrian refugees egypt, iraq lebanon crisis response plan communicable diseases in complex emergencies: impact and challenges where we work the providers of health services in lebanon: a survey of physicians syrian 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public health l. national health accounts summary table syria response plan-lebanon hospital accreditation, reimbursement and case mix: links and insights for contractual systems annual report of primary healthcare department. ministry of public health, lebanon ministry of public health. ebola outbreak lebanese health minister launches reform plan department of control on public hospitals, ministry of public health. rafic hariri university hospital utilization data world health organization. health-financing and access to effective interventions world health organization. global health data observatory repository global health observatory data trends in maternal mortality: to global, regional, and national levels of neonatal, infant, and under- mortality during - : a systematic analysis for the global burden of disease study p - years of polio/afp surveillance in lebanon: - world health organization current health event tuberculosis national tuberculosis program, ministry of public health. tuberculosis treatment outcomes a network based theory of health systems and cycles of well-being building resilient health systems and learning from the ebola crisis. oxford, united kingdom informal politics and inequity of access to health care in lebanon summer war in lebanon: a lesson in community resilience postemergency health services for refugee and host populations in uganda acknowledgments: this work would have never been possible without the efforts of various de- key: cord- -rsifxvtj authors: lim, meng-kin title: global response to pandemic flu: more research needed on a critical front date: - - journal: health res policy syst doi: . / - - - sha: doc_id: cord_uid: rsifxvtj if and when sustained human-to-human transmission of h n becomes a reality, the world will no longer be dealing with sporadic avian flu borne along migratory flight paths of birds, but aviation flu – winged at subsonic speed along commercial air conduits to every corner of planet earth. given that air transportation is the one feature that most differentiates present day transmission scenarios from those in , our present inability to prevent spread of influenza by international air travel, as reckoned by the world health organization, constitutes a major weakness in the current global preparedness plan against pandemic flu. despite the lessons of sars, it is surprising that aviation-related health policy options have not been more rigorously evaluated, or scientific research aimed at strengthening public health measures on the air transportation front, more energetically pursued. air transportation has undoubtedly been a boon to humankind -bringing together peoples, cultures and values, and profoundly changing the way we live. but it has also greatly aided the global transmission of infectious disease. in the old days, geographical distance provided a measure of protection as signs and symptoms had time to develop and those afflicted could be screened at border entry points. today, with hardly an airport unreachable within hours from any point on our planet, the speed -and pattern -of microbial movements has altered dramatically. in , the institute of medicine report emerging infections: microbial threats to health in the united states correctly identified "microbial adaptation and change" and "expanding international travel and commerce" as two of the major factors contributing to disease emergence and re-emergence [ ] . severe acute respiratory syndrome (sars), in retrospect, epitomized this new model of disease outbreak. the previously unrecognized sars-cov coronavirus mysteriously surfaced in guangdong province, china, in november , simmered there for three months, and arrived in hong kong on a jet plane. from that busy aviation hub, it quickly spread to vietnam, singapore, and canada, eventually afflicting countries and taking lives [ ]. thankfully, sars did not progress to a full-blown pandemic as was widely feared. for reasons that are still unclear, the disease fizzled out, leaving us unsure as to whether we licked it or were just plain lucky. with avian flu now on everybody's mind, it is worth recalling the grim images of those dark days not so long ago -when some of the busiest airports in the world lay deserted as panic-stricken, would-be travelers stayed home. anxious aircrew clamored for adequate protection at work [ ] while medical and airline industry officials rejected the notion that the virus could be transmitted on airplanesuntil the world health organization (who) weighed in to say that travelers seated within two rows of an infected person could be in danger. we now know that passengers sitting eight rows away are not any safer, and that out of a total of commercial air flights investigated for carrying sars infected passengers, five have been found to be associated with probable onboard transmission of sars, involving passengers in all [ ] . the first in-flight transmission of sars occurred in a female flight attendant who caught it from a family of three singaporeans incubating the virus on a singapore airlines flight between new york and frankfurt on march [ ] . soon after, more cases were reported, such as when a cluster of thirteen passengers from hong kong was infected during an air china flight to beijing on march , with a year fellow passenger believed to be the source [ ] . then there was the pandemonium which broke when a certain -year-old man with symptoms of sars was discovered to have flown on lufthansa from hong kong to munich, barcelona, frankfurt, london, munich again, frankfurt again, and back to hong kong before entering a hospital on his own accord. on april , the hong kong department of health had to desperately appeal for passengers and aircrew from all seven flights to consult their doctors [ ] . as the fear of sars became more contagious than the contagion itself, stock markets tumbled and billions of dollars were lost. coming close at the heels of / and the iraq war, sars dashed hopes of recovery for the ailing airline industry. the latter is understandably not saying very much these days about any avian flu contingency plans they might have; one certainly hopes that appropriate preventive measures are being put into place. but that may be just the problem: what is the evidential base for effective public health interventions in the aviation industry, and how rigorously have the relevant aviation policy options been evaluated in the intervening years since the sars episode [ ] ? take thermal scanners for instance -first deployed in singapore's changi airport and enthusiastically adopted by other "high-risk" airports around the world, in answer to the international civil aviation organization's (icao) call for mass-screening of arriving and departing passengers and crews for raised temperature [ ] . it was an innovative application of military technology to address an urgent need. to date, however, we are none the wiser regarding the sensitivity, specificity, or cost effectiveness of this screening tool for sars, much less its usefulness for influenza. about all we know is that canadian officials reportedly screened million passengers with thermal scanners at an estimated cost of can$ . million, without detecting a single case of sars [ , ] . no one knows for sure what preventive measures all airlines and airports of the world should uniformly adopt in order to mitigate the spread of infectious diseases by air. the who's global influenza preparedness plan merely acknowledges, without elaboration, that "air travel might hasten the spread of a new virus, and decrease the time available for preparing interventions" [ ] while icao's current website repeats the same general measures that it had posted for sars [ ] . with the threat of an influenza pandemic looming, which by all accounts will make sars pale in comparison, all we have to go by today is the same generic advice on hand washing and personal hygiene for airline workers, and a negative assurance of sorts from the us centers for disease control and prevention (cdc) that "there is no evidence that avian influenza is spread through contact with baggage, packages, or other objects..." [ ] . apart from the desperate culling of affected poultry, much of the current global preparatory activities against avian flu pandemic revolve around surveillance, diagnostics, hospital infection control, vaccines production, and stockpile of antiviral agents. these efforts are necessary and laudable, but might they not also reflect the "medical" bias of existing paradigms? the sars episode had highlighted the importance of enlisting travel industry workers and travelers as frontline fighters in the global response. if and when sustained human-to-human transmission of h n becomes a reality, the world will no longer be dealing with sporadic avian flu borne along migratory flight paths of birds [ , ] but aviation fluwinged at subsonic speed along commercial air conduits to every corner of planet earth. surely any global battle plan against pandemic flu should entertain the notion of stopping the enemy at the gates, or along the corridors of its advance, before it reaches our homes, hospitals and clinics? alas, the who report avian influenza: assessing the pandemic has dismally concluded that "if only a few countries are affected, travel-related measures, such as exit screening for persons departing from affected areas, might delay international spread somewhat, but cannot stop it. when large numbers of cases occur ... entry screening at airports and borders will have no impact" [ ] . granted, if a substantial portion of transmission occurs during the incubation or asymptomatic phase of disease, entry screening is unlikely to be effective in preventing or delay-ing an epidemic resulting from the importation of influenza [ ] ; and granted, the short time lag for scrambling upon discovery of a sentinel case will pose serious challenges to effective quarantine and contact tracing measures; but are we acquiescing on this critical front too readily? sensible actions depend on knowing precisely what is going on, which in turn depends on good quality data. the fact of the matter is, we have simply not invested enough in the kind of multidisciplinary research needed, involving epidemiology [ ] , mathematical modeling [ ] , computational simulation [ ] , electronic tracking [ ] , and biological detection technology [ ] , to name a few, to elucidate the dynamics of microbial transmission associated with air travel, be it in aircraft cabins, toilets, or transit lounges. four years after sars, and we are no clearer regarding the complex spatial interactions of travelers converging on busy air terminals; or how best such human traffic may be channeled to minimize the risk of viral transmission; or what impact stringent screening impositions would have on passenger reaction and behavior. if the economic and wider arguments for maintaining continuity of air traffic flow (without which many nations could find their ability to keep going during a pandemic severely impaired) are not well researched and understood beforehand, arbitrary and capricious actions such as panic closure of borders, possibly leading to an abrupt global shut-down, could well result. the current view is that under most scenarios, restrictions on air travel are likely to be of little value in delaying the proliferation of epidemics, unless almost all travel ceases very soon after epidemics are detected [ ] . but if the technology for picking out passengers capable of transmitting deadly pathogens and setting off killer epidemics does not exist today, should we not be pursuing it as energetically as we do, the technology for stopping terrorists from boarding a plane? against a conservatively estimated us$ billion a year that a human pandemic of avian influenza could cost the global economy [ ] , not to mention the incalculable cost in terms of human lives [ ] , it seems incredible that the aviation lessons of sars have not led to an acceleration of scientific research and health policy evaluation aimed at strengthening public health defenses on the air transportation front. to put things in perspective, we are engaged in a millennia-old, interspecies struggle between man and microbes. while the unseen enemy thrives because of its capacity for relentless adaptation and opportunistic spread, our own record of survival and progress owes much to the fact that at every critical turn, we have somehow managed to ask the right questions and looked hard enough at the right places for the right answers -be it in quarantine and vaccination strategies or an armamentarium of antibiotics and antiviral agents. in the coming epic battle against pandemic flu, the stakes have never been higher. if our strategies (read: health policies) are to work, they must be reliably informed by accurate intelligence (read: health research) which must cover all bases. given that international air travel is the one feature that most differentiates present day transmission scenarios from those in , it is surely relevant to ask, just how flu-ready are the airlines and airports of the world? the call is for more scientific research devoted to this critical front. two aspects deserve particular attention: (a) the science of transmission of infection between individuals and nations via air transportation and (b) the rigorous examination of policy options, based on the evidence and taking into consideration the economic trade-offs required. resolving the tension between these aspects (and between the concerns of doomsday modelers and real-world policy makers in government, world health and air transport organizations) will improve the confusing impasse we seem to be in at present. emerging infections: microbial threats to health in the united states. committee on emerging microbial threats to health. institute of medicine the association of flight attendants: flight attendants demand protection from sars. afl-cio press release transmission of infectious diseases during commercial air travel sars and occupational health in the air. occupational and environmental medicine transmission of the severe acute respiratory syndrome on aircraft using lessons from the past to plan for pandemic flu icao takes action on sars. aviation international news border screening for sars. emerg infect dis quarantine and isolation: lessons learned from sars. a report to the centers for disease control and prevention institute for bioethics world health organization department of communicable disease surveillance and response global influenza programme: who global influenza preparedness plan-the role of who and recommendations for national measures before and during pandemics airport readiness for possible pandemic benefits from experience with sars guidance for airline cleaning crew, maintenance crew, and baggage/ package and cargo handlers for airlines returning from areas affected by avian influenza a (h n ) highly pathogenic h n influenza virus infection in migratory birds avian flu: h n virus outbreak in migratory waterfowl world health organization: avian influenza: assessing the pandemic threat entry screening for severe acute respiratory syndrome (sars) or influenza: policy evaluation global epidemiology of influenza: past and present a mathematical model for the global spread of influenza assessing the impact of airline travel on the geographic spread of pandemic influenza uk home office publictechnology.net. e-borders will fence uk & use it to track and identify passengers research and development in biosensors delaying the international spread of pandemic influenza avian and human pandemic influenza-economic and social impacts bird flu may kill m, warns un the author(s) declare that they have no competing interests. key: cord- -stod j authors: parekh, niyati; deierlein, andrea l title: health behaviours during the coronavirus disease pandemic: implications for obesity date: - - journal: public health nutrition doi: . /s sha: doc_id: cord_uid: stod j objective: obesity is a risk factor for severe complications and death from the coronavirus disease (covid- ). public health efforts to control the pandemic may alter health behaviors related to weight gain, inflammation, and poor cardiometabolic health, exacerbating the prevalence of obesity, poor immune health, and chronic diseases. design: we reviewed how the pandemic adversely influences many of these behaviors, specifically physical activity, sedentary behaviors, sleep, and dietary intakes, and provided individual level strategies that may be used to mitigate them. results: at the community level and higher, public health and health care professionals need to advocate for intervention strategies and policy changes that address these behaviors, such as increasing nutrition assistance programs and creating designated areas for recreation and active transportation, to reduce disparities among vulnerable populations. conclusions: the long-lasting impact of the pandemic on health behaviors, and the possibility of a second covid- wave, emphasize the need for creative and evolving, multi-level approaches to assist individuals in adapting their health behaviors to prevent both chronic and infectious diseases. obesity is a major public health concern in the usa. there are approximately % of americans with obesity (defined as a bmi > kg/m ), of which % suffer from severe obesity (bmi > kg/m ) ( ) . emerging evidence suggests that obesity is a strong risk factor for severe complications, hospitalisation and death from the coronavirus disease (covid- ) ( ) . in new york city, compared with adults (aged < years) with a bmi < kg/m , those with a bmi - kg/m and those with a bmi > kg/m were · ( % ci · , · ) times and · ( % ci · , · ) times more likely to be admitted to acute and critical care, respectively ( ) . although the specific biological mechanisms continue to be elucidated, inflammation and immune dysregulation are central to the aetiology of covid- , attacking the lungs and vasculature system and progressing to the heart, kidneys and other organs throughout the body ( , ) . individuals with obesity may be particularly susceptible to covid- infection due to the range of comorbidities associated with excess adiposity, including hyperglycaemia, hypertension, inflammation and impaired respiratory function ( ) . while social distancing measures are necessary to control the pandemic, they will also have unintentional consequences that may worsen the obesity epidemic and its related comorbidities in the usa. sheltering-in-place has significantly altered health behaviours and the food environment by limiting opportunities for daily physical activities, encouraging screen time and sedentary behaviours, disturbing sleep and promoting consumption of ultraprocessed foods and alcohol. all of these behaviours may contribute to weight gain and the development of cardiometabolic diseases, such as diabetes, hypertension and cvd. during this time, public health professionals are faced with the dual challenge of continuing to promote obesity prevention strategies, while supporting covid- containment efforts. herein, we discuss modifiable behavioural risk factors for weight gain that have been affected by the pandemic: physical activity, sedentary behaviours, sleep and diet (fig. ) . we provide strategies to improve them, which can be incorporated into public health messaging, interventions and tele-medicine during this period. the majority of american adults do not meet the national recommendations of at least min of moderate physical activity or min of vigorous physical activity (or an equivalent combination) per week ( ) . physical activity is associated with a wide range of meaningful health benefits. individuals who engage in regular physical activity are more likely to have a healthy weight status; reduced risks of cardiometabolic diseases, some cancers and osteoporosis; improved cognition; and shorter periods of depression and anxiety ( ) . physical activity is also critical for improving quality of life among individuals with chronic conditions and disabilities. social distancing and lockdown measures have diminished opportunities to participate in several domains of physical activity, particularly those related to recreation, transportation and work. recreational sources of activity, such as health clubs, gyms, pools, and indoor and outdoor sports facilities (e.g., tennis and basketball courts), have limited access and even after re-opening many individuals may be reluctant to use them. daily activities associated with transportation and work, for example, walking a child to the bus stop, running errands or climbing a flight of stairs at the office, have also been drastically reduced. these short bouts of activity throughout the day are important contributors to daily energy expenditure and weight gain prevention and allow for breaks in sedentary behaviours. during this time, efforts should be made to schedule movement throughout the day, particularly for individuals who do not have a regular exercise routine. walking is an excellent low-impact exercise that can improve cardiovascular fitness and increase energy expenditure, even in short -min increments ( ) . caregiving and household activities, such as playing with children, cleaning and gardening, may also be used to off-set lost daily activities from other domains. additionally, at-home exercise classes and programmes are available for free or low cost on many social media platforms (e.g., instagram, youtube and facebook) for various types of exercises and skill levels. information on these resources and other physical activity strategies can be tailored and distributed to target populations. the average american adult spends · - · h/d engaged in sedentary behaviours, such as sitting while working, higher alcohol intake fig. (colour online) interrelationships of behavioural risk factors for weight gain that have been affected by the covid pandemic; the confluence of these behavioural changes is hypothesised to exacerbate the national prevalence of obesity that is a threat for disease severity and mortality reading, watching television and using computers, smartphones or other devices ( ) . although the overall evidence for an association between sedentary behaviours and obesity in adults is inconsistent, sitting for extended time periods is associated with greater waist circumference and higher blood levels of tag, glucose and insulin, which are biomarkers of poor cardiometabolic health ( ) . the types of sedentary behaviours that individuals engage in are also important. among all of the sedentary behaviours, television watching likely has the greatest influence on weight gain due to the obesogenic behaviours that accompany it ( ) . television watching is an environmental stimulus that increases food intakes, independent of hunger-satiety signals or food palatability; therefore, consumption of meals and energy-dense snack foods in front of the television may result in excess energy, fat and sugar intakes ( ) . television watching also exposes individuals to advertisements for unhealthy foods and beverages, which may further encourage their consumption ( ) . for the majority of individuals, stay-at-home measures have increased sedentary time, especially among apartment dwellers. physical activity breaks throughout sedentary time can reduce sitting-related health risks and are associated with lower bmi and improved cardiometabolic health biomarkers ( ) . individuals can also keep meals and snacking separate from all work-, school-and leisure-related sedentary behaviours to reduce opportunities for overeating and junk food consumption. modern society has resulted in an increased prevalence of deficient sleep health, which encompasses inadequate sleep duration, poor sleep quality and sleep disorders. the average american adult suffers from deficient sleep due to sleeping less than the recommended - h/night, having a job that requires shift work and/or having a sleep disorder (e.g., insomnia, sleep apnoea) ( ) . deficient sleep is associated with increased risks of diabetes, hypertension, cvd and obesity ( ) . experimental studies demonstrate that restricted or impaired sleep reduces glucose tolerance and insulin sensitivity and alters appetite-regulating hormones, resulting in decreased satiety and increased feelings of reward and pleasure in response to food stimuli ( ) . individuals with short or disrupted sleep report greater energy intakes, which may be attributed to more frequent meal occasions, larger portion sizes and preference for energy-dense foods that are high in fat and carbohydrates ( ) . moreover, energy expenditure from physical activities is often reduced among people with inadequate sleep ( ) . the pandemic may disrupt and shorten sleep in several ways, including altering usual bed times (e.g., going to bed later), increasing screen time and intensifying anxiety and stress levels. individuals may be able to overcome some of this disruption by maintaining good sleep hygiene practices, such as setting a consistent sleep/wake routine, extending sleep duration to meet recommended amounts and avoiding or reducing blue light exposure from screen use (using blue light blocking glasses or software) around bedtime, since blue light may interfere with melatonin levels and stimulate brain activity ( ) . limiting late-night snacking and alcohol consumption and achieving recommended amounts of daily physical activity also help to regulate sleep. the external and household food environments are strongly correlated with individual diet quality and health. greater access to and purchases of fruits, vegetables and whole grains are associated with higher nutrient intakes, improved immune function and reduced chronic illness, while greater access to and purchases of ultra-processed foods are associated with nutrient deficiencies and chronic disease development ( ) . ultra-processed foods are defined as industrially manufactured, ready-to-eat or ready-to-heat formulations, which contain little to no whole, fresh foods. prior to the pandemic, ultra-processed foods constituted the majority of energies purchased by us households and were the main source of total and added sugars, na and fats. although some ultra-processed foods may provide vitamins and other essential nutrients (e.g., vitamin c, n- fatty acids and folic acid), the majority of these foods contain preservatives and additives (e.g., na, trans fats, high fructose maize syrup, artificial colourings, nitrites and sulphites), as well as neo-formed contaminants and chemicals ( , ) . these ingredients are hypothesised to influence cardiometabolic disease development through several mechanisms, including dysregulating blood lipid, glucose and hormone concentrations; altering gut microbiota; increasing body fat stores; and generating oxidative stress and inflammation ( , ) . additionally, ultra-processed foods are hypothesised to promote poor dietary habits, such as snacking and overeating, due to their convenience, omnipresence, low cost and large portion sizes ( ) . the pandemic has drastically changed the food environment. record high unemployment rates compounded by interruptions in the food supply chain due to worker shortages, heightened safety inspections and delays in the transportation and delivery of fresh foods have left consumers with no choice but to consume what they can afford and access at their local food stores. lockdown measures have also reduced the frequency of grocery shopping, further decreasing the ability to purchase perishable fresh foods, particularly produce. rates of household food insecurity are mounting and early reports from grocery retail stores demonstrate historically high sales of shelf-stable and ultra-processed foods, such as boxed macaroni and cheese and snack foods, as well as alcohol ( , ) . aside from issues surrounding substance abuse and mental health, alcohol consumption is associated with stimulating appetite, overeating and weight gain. although achieving optimal dietary quality is challenging during this time, individuals can make several efforts to increase their intakes of nutrient-dense foods. grocery store purchases should focus on frozen, canned (low na varieties) or dried plant-based items, like whole grains (e.g., brown rice, whole grain maize meal, whole wheat pasta and oats), pulses (legumes and beans), vegetables and fruits, as well as fresh produce that does not quickly perish, such as apples, pears, cabbage, carrots, squashes, sweet potatoes and beets. gardening, even in window sills and balconies, may further help to encourage consumption of vegetables, fruits and fresh herbs. stay-at-home measures have also increased reliance on cooking and baking, which provides the opportunity to make more healthful versions of storebought processed foods. for example, soups and stews, pizza, breads and cookies may all be home made with whole grains, vegetables and low sugar and salt content. beverage consumption should focus on varieties of water (e.g., plain, seltzer and fruit infused), while avoiding all sugar-sweetened beverages. the us dietary guidelines recommend that if alcohol is consumed then it should be done in moderation, defined as up to one drink for women and two drinks for men per day ( ) . for individuals who consume alcohol, daily drinking should be limited and should not be higher than pre-pandemic intakes, which may suggest that alcohol is being used as a coping mechanism for social isolation, boredom and other stressors. historically, obesity has been of public health concern due to its strong associations with chronic disease morbidity and mortality. the covid- pandemic has highlighted that obesity greatly increases susceptibility to complications and mortality from infectious diseases as well. public health measures to control the pandemic may alter health behaviours related to weight gain, inflammation and poor cardiometabolic health, exacerbating the prevalence of obesity, poor immune health and chronic diseases in the usa and other countries with developed economies. however, for many of these behaviours, specifically physical activity, sedentary behaviours, sleep and dietary intakes, the influence of the pandemic can be mitigated. table summarises individual-level practices related to each behaviour that may be promoted during this time. at the community level and higher, public health and health care professionals need to advocate for intervention strategies and policy changes that address these behaviours. for example, expanding community nutrition services and government food assistance programmes to reduce disparities among vulnerable populations or increasing designated areas for recreation and active transportation, such as green spaces, street traffic closures and protected bike lanes to provide safe spaces for individuals to exercise, walk, run and bike while maintaining social distance, particularly in urban areas. the long-lasting impact of the pandemic on health behaviours and the possibility of a second covid- wave emphasise the need for creative and evolving, multi-level approaches to assist individuals in adapting their health behaviours to improve immune function and prevent both chronic and infectious diseases. during extended periods of screen time • limit late-night snacking and avoid eating in the absence of hunger • limit consumption of packaged salty and sweet foods and sugarsweetened beverages • consume more plant-based foods, specifically whole grains, vegetables, fruits, lean proteins and dairy. substitute with lowsugar, low-salt frozen or canned items if fresh produce is unavailable • cook healthy meals at home • maintain good sleep hygiene practices; aim for at least h of sleep every night, avoid screens, bright lights, and caffeinated and alcoholic drinks before bed • consume alcohol in moderation or do not drink at all • cope with stress by doing breathing exercises, yoga, meditation, engaging in regular activity and ensuring sufficient sleep prevalence of obesity and severe obesity among adults: united states obesity a risk factor for severe covid- infection: multiple potential mechanisms obesity in patients younger than years is a risk factor for covid- hospital admission covid- cytokine storm: the interplay between inflammation and coagulation obesity and impaired metabolic health in patients with covid- physical activity and public health: updated recommendation for adults from the american college of sports medicine and the american heart association physical activity, exercise, and chronic diseases: a brief review the importance of walking to public health screen time, other sedentary behaviours, and obesity risk in adults: a review of reviews sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis non food-related environmental stimuli induce increased meal intake in healthy women: comparison of television viewing versus listening to a recorded story in laboratory settings priming effects of television food advertising on eating behavior meta-analysis of the relationship between breaks in sedentary behavior and cardiometabolic health the epidemiology of sleep and obesity short sleep duration and dietary intake: epidemiologic evidence, mechanisms, and health implications the role of sleep duration in the regulation of energy balance: effects on energy intakes and expenditure dealing with sleep problems during home confinement due to the covid- outbreak: practical recommendations from a task force of the european cbt-i academy characterization of the degree of food processing in relation with its health potential and effects ultraprocessed products are becoming dominant in the global food system the un decade of nutrition, the nova food classification and the trouble with ultra-processing ultra-processed diets cause excess calorie intake and weight gain: an inpatient randomized controlled trial of ad libitum food intake americans drop kale and quinoa to lock down with chips and oreos pandemic drives alcohol sales -and raises concerns about substance abuse dietary guidelines for americans th edition acknowledgements: none. financial support: none. conflict of interest: none. authorship: a.d. and n.p. wrote this work. ethics of human subject participants: not applicable. key: cord- -rj le qn authors: felknor, sarah a.; streit, jessica m. k.; chosewood, l. casey; mcdaniel, michelle; schulte, paul a.; delclos, george l. title: how will the future of work shape the osh professional of the future? a workshop summary date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: rj le qn rapid and profound changes anticipated in the future of work will have significant implications for the education and training of occupational safety and health (osh) professionals and the workforce. as the nature of the workplace, work, and the workforce change, the osh field must expand its focus to include existing and new hazards (some yet unknown), consider how to protect the health and well-being of a diverse workforce, and understand and mitigate the safety implications of new work arrangements. preparing for these changes is critical to developing proactive systems that can protect workers, prevent injury and illness, and promote worker well-being. an in-person workshop held on february – , at the university of texas health science center (uthealth) school of public health in houston, texas, usa, examined some of the challenges and opportunities osh education will face in both academic and industry settings. the onslaught of the covid- global pandemic reached the united states one month after this workshop and greatly accelerated the pace of change. this article summarizes presentations from national experts and thought leaders across the spectrum of osh and professionals in the fields of strategic foresight, systems thinking, and industry, and provides recommendations for the field. the world is undergoing major changes in the way work is performed, the workforce, and the workplace. with the goal of increasing productivity and the greater incorporation of technology, the pace of work has intensified. while short-term, temporary employment arrangements represent greater flexibility for employers, they can translate into more precarious situations for workers; lower pay for equivalent education, skills, and experience compared to those with long-term contracts; fewer benefits; and greater turnover [ ] [ ] [ ] . thirty percent of the u.s. workforce now engages in nonstandard work arrangements, such as contingent work, temporary contracts, and part-time work [ ] . additionally, estimates of teleworking under the covid- pandemic reached upwards of % of all employed u.s. adults, and that number is expected to increase long after the pandemic [ ] . future of work scenarios describe an increasing global reliance on the informal sector and hazardous work exposures that are exacerbated by work-life stress and health consequences of precarious work [ ] . this first workshop examined how the future of work will likely shape education and training for the next generation of osh professionals. the objectives were to (a) examine the impact of future of work (fow) on how we train the osh professional workforce; (b) identify gaps and needs related to training and education; and (c) inform the agenda of the international conference. workshop attendees represented a broad cross-section of stakeholders, including adult educators, worker representatives, government employers, industry professionals, the academic community, and consultants. participants were identified using a modified snowball technique. the organizing committee generated an initial list of experts who were asked to nominate additional participants from a wide range of disciplines and professions relevant to the topic of the workshop. a final list of invited participants included experts from public, private, and non-governmental agencies representing the following sectors: academic research, education, construction, government, healthcare, management, organized labor, and workers' rights. most of the participants were from academic institutions ( %), followed by government ( %), industry ( %), non-governmental agencies ( %), and labor ( %). internationally recognized niosh thought leaders first provided an overview of the fow and its likely impacts on worker health and well-being. thereafter, the workshop format was structured along three themes: ( ) innovative approaches to adult education, ( ) the role of systems thinking in osh education and training, and ( ) what the future osh professional "should" or "will" look like. keynote speakers introduced each of these three themes and then facilitated small group discussions where participants addressed specific questions or challenges posed by the speakers. to foster greater interprofessional interaction, the small group composition was randomized and changed for each breakout session so that, by the end of the workshop, participants had worked with virtually all other attendees. debriefing sessions provided an opportunity to link the discussions back to the workshop objectives, summarize gaps and needs, and generate conclusions. workshop notes and recordings were transcribed and edited by the authors. thematic analysis was carried out on small group discussion transcriptions using an inductive multi-phased approach to synthesize input and identify axial themes and representative statements. the results of the thematic analysis are shown in tables - . cooperates with other disciplines and professional fields -identify a broad set of osh collaborators, such as policymakers; professional societies and groups (e.g., acoem, acgih, asa); employers (including small, medium, and large enterprises); city, county, and state governments; public health professionals; medicine and nursing professionals; environmental health and safety professionals; social scientists; and wellness/health promotion groups -provide strategies to identify key conceptual overlaps with stakeholders and approaches for capitalizing on shared interests advocates for the osh cause at all times and to all audiences -embed osh professionals into industry in order to bring recognition to the relevance and importance of osh, build leadership support, raise employee awareness, and purposefully prioritize organizational problems -encourage interaction between osh and non-osh professionals to engage wider group of professionals to advocate for and support frontline osh activities. -lead by example, leveraging major public health events (e.g., floods, pandemics) to highlight community-wide relevance of osh. * attributes and strategies reflect an integrated summary of the input provided by workshop breakout groups. this section provides a summary of all workshop presentations and the results of group discussions that identified the challenges, gaps and needs of the three workshop themes described above. the niosh fow initiative was launched in and applies the total worker health ® (twh) framework by encouraging collaboration across organizational policies, programs, and practices. central to both of these niosh futures-oriented priorities is the concept of worker well-being, which integrates the traditional osh goal of protecting workers from occupational hazards with the promotion of health and illness prevention in the workplace and is being operationalized by niosh through its twh program [ , ] . twh promotes using more holistic approaches to broaden the focus from one narrowly centered on workplaces to those which incorporate both work-related and non-work-related factors that impact worker well-being, either positively or negatively [ ] . therefore, according to this contemporary conceptual framework, worker well-being emphasizes quality of life and is driven by the relationship between individual worker health and factors both at and outside the workplace, in order to have workers thrive and achieve their full potential [ ] . since the start of niosh twh activities (https://www.cdc.gov/niosh/twh/) in , there has been progress in advancing this niosh priority. examples include funding and establishing twh centers of excellence, improving the definitions and conceptual frameworks for well-being (noted in the previous paragraph), and identifying gaps and needs in research and applied interventions [ , , , ]. however, as knowledge advances, new needs and existing gaps emerge, and niosh seeks to build on these advances and identify current needs and gaps. niosh's new fow initiative (https: //www.cdc.gov/niosh/topics/future-of-work/default.html) was launched to compile what is known about fow scenarios and emerging trends and support new research, with an eye towards being able to forecast and anticipate risks that fow may bring. priority areas of focus include organizational design, changes in work arrangements, emerging technological demands (including job displacement), artificial intelligence, robotics, and other innovative technologies. the effort will highlight demonstration projects aimed at enhancing skills and economic security [ ] . the unprecedented expansion of the use of ai in the workplace and its potential impacts on worker safety will change tasks workers perform and how they are protected from new and existing workplace hazards. ai will bring expanded use of sensors to detect and mitigate exposures, increased risks of human-robot interaction and autonomous vehicles, anticipated technological displacement, and greater incorporation of the internet of things into our lives. the large amount of data generated through technological advances will result in a greater need for occupational analytics and decision-making by decision data scientists and ai systems. ai will pose new challenges for osh professionals as they prepare to respond technically and ethically to these changes [ ] . the osh field will need an expanded, more holistic focus to address challenges and changes posed by fow scenarios to prepare the professionals of the future. this paradigm shift challenges traditional osh systems by focusing on worker well-being as an outcome, goes beyond the prevention of workplace injury and illness or health promotion, and expands the types of hazards typically considered in the traditional osh paradigm. the world health organization (who) model for action, various european efforts at well-being, and the niosh twh program provide important foundations for addressing changes in the world of work [ ] . beyond this, though, we need a more expansive paradigm to include greater recognition of both individual worker and workforce well-being as important osh outcomes. embracing this paradigm shift mandates a more expansive, systems thinking approach to better integrate traditional osh with personal and socioeconomic risk factors, both horizontally (broadening the range of factors to examine their impact on health) and vertically (from a short-term, single job perspective to a work life continuum perspective encompassed by the overarching concept of well-being) [ ] . this will require greater interprofessionalism, collaborative organizational leadership, proactive company policies, accountability, training, and engagement of management and employees, as well as following benchmarks over time and identifying opportunities for early corrective or enhancing interventions [ ] . moreover, as the paradigm expands, there will be a need for greater integration of systems thinking and transdisciplinary efforts, and for finding innovative ways to attract and train students into osh professions. systems thinking is the process of understanding the interconnection of elements (systems) that are organized to achieve a specific purpose [ ] . transdisciplinary efforts are those that cross multiple disciplines and professions and result in a broader and more holistic approach to problems solving strategies [ ] . it is therefore likely that there will be a need for new disciplines and specialties in osh or, at a minimum, a broader skill set and expanded training of traditional osh professions to include occupational health psychology, human resource management, and twh [ ] . the model for this expanded focus for osh was modified from schulte et al. [ , ] and is presented in figure . systems thinking approach to better integrate traditional osh with personal and socioeconomic risk factors, both horizontally (broadening the range of factors to examine their impact on health) and vertically (from a short-term, single job perspective to a work life continuum perspective encompassed by the overarching concept of well-being) [ ] . this will require greater interprofessionalism, collaborative organizational leadership, proactive company policies, accountability, training, and engagement of management and employees, as well as following benchmarks over time and identifying opportunities for early corrective or enhancing interventions [ ] . moreover, as the paradigm expands, there will be a need for greater integration of systems thinking and transdisciplinary efforts, and for finding innovative ways to attract and train students into osh professions. systems thinking is the process of understanding the interconnection of elements (systems) that are organized to achieve a specific purpose [ ] . transdisciplinary efforts are those that cross multiple disciplines and professions and result in a broader and more holistic approach to problems solving strategies [ ] . it is therefore likely that there will be a need for new disciplines and specialties in osh or, at a minimum, a broader skill set and expanded training of traditional osh professions to include occupational health psychology, human resource management, and twh [ ] . the model for this expanded focus for osh was modified from schulte et al. [ , ] and is presented in figure . [ ] , eurofound [ ] , and twh [ , ] . the future of learning and education must consider three major shifts in adult education that are shaping how we meet the learning needs of an increasingly diverse workforce in the future. these include new types of learners, new ways of learning, and new things to learn. changes in the nature of work are presenting challenges to the educational institutions to adapt or face the consequences. the increasing diversity of the workforce is also changing education and learning needs. there is a shifting balance of power between students and institutions, with the former carrying an increasingly greater weight and demanding novel approaches to learning [ ] . student types are transitioning from a traditional sequential learning pathway (e.g., from high school straight to college) to working students who attend part-time; are often older; come from diverse backgrounds; and have a need to balance work, study, and home life. over time, they may have accumulated bits and pieces of educational credits and work experiences from different places. they are also more attuned to "on-demand" education, at a pace that fits more of a "just-in-time" lifestyle. and there is a transition from traditional major-based college tracks to more personalized learning, where students focus primarily on a declared life mission and seek to combine their educational experiences with the purpose of fueling that mission [ , ] . the covid- pandemic has abruptly changed the education paradigm in the united states to essentially an entirely online platform, and this learning delivery method can be expected to see increasing demand in the future. new approaches to learning are needed to more effectively engage nontraditional working students. in response, learning offerings are diversifying and moving towards faster, cheaper alternatives. examples include more online, virtual, and micro-courses; massive open online courses (moocs) and other open courseware; certificate (rather than traditional degree) programs; expanded opportunities for applied/hands-on training; and models that support lifelong learning [ ] . an important consequence of these changes will be their impact on accreditation of education programs, which are vital to osh professional training (e.g., who will certify that coursework is adequate or that competencies have been achieved?). finally, there are new things to learn, much of it driven by the digital transformation that characterizes the fourth industrial revolution, and the need for greater ai-human interfacing at work and augmentation of human skills with technology. new skills that will be valued include systems thinking, human creativity and innovation, cultural and technological literacy, data analysis, problem-solving, working from a transdisciplinary perspective, social networking, and dealing with uncertainty, among others. there is a strong case to be made that many of these skills should start to be acquired early in life (e.g., during the k- experience) and solidified thereafter during higher education [ ] . it is important to note that the workshop was designed to identify challenges, gaps, and needs facing the future of education and training of osh professionals and not necessarily to provide concrete answers or next steps in the development of curricula, credentialing of osh professions, or evaluation of new training methods. therefore, the following questions were used to frame discussion of the key changes that are needed in education and learning in the future: ( ) how can we more effectively meet the education and learning needs of an increasingly diverse osh workforce? ( ) in what ways can we expand our learning offerings to more effectively engage future osh professionals? ( ) with the rapid pace of change, including the rise of intelligent software and machines, what content is important for future osh professionals to learn? the discussion groups identified major challenges facing education and learning for future osh professionals, such as diversity, technology, evaluation, and the decline in the number of current osh professionals. challenges around diversity include the growing heterogeneity in the characteristics and needs of osh trainees and workers. rapidly evolving technology will challenge how osh trainees learn and how training is delivered. evaluation challenges include the ways in which we measure, assess, or certify learning and skills development. moreover, the decline in the number of osh professionals challenges the training of the next generation of osh professionals and opportunities for mentoring and meaningful placement of graduates. participants then identified gaps and needs for osh education, conceptualizing them as key changes and important implications for the future of osh training. a summary of these small group discussions is provided in table . first changes to recruitment, educational approaches, classroom power dynamics, resilience training, and credentialing will be needed to more effectively serve future osh learners; however, these changes will have implications for osh core competencies, the security and longevity of osh training programs, and approaches to quality control in osh education. next, changes to training diversity and interpersonal connectedness will be needed to more effectively engage nontraditional osh learners with new types of learning, and these changes will have implications for osh advocacy, community-based learning, and the realities experienced by both educators and learners. finally, curricula should expand to include important new content and foster the development of a transdisciplinary workforce. examples of new training content include an ecological model for worker health, the causes and consequences of new technologies at work, interpersonal skills, and advanced data analytics. such changes will have implications for osh culture, osh training evaluation systems, and osh educator preparation programs. systems thinking provides an approach that can be applied to better understand how employers and workers are responding, often in counterproductive ways, to the connected problems of global competition, technology disruption, and stress-related illness. a systems approach to better understanding organizations has long been advocated by social psychologists [ ] . system refers to an interconnected set of elements coherently organized in a way that achieves something [ ] . systems thinking, then, is the ability to understand these interconnections in such a way as to achieve a desired purpose, with the goal of knowing more about the whole system. conventional thinking typically assumes problems and causes are clearly connected; that others are to blame; that short-term, often multiple, interventions result in long-term success; and that individual components of a problem can be optimized. in contrast, systems thinking does not assume an obvious connection between problems and causes; understands that quick fixes may not improve (and, in fact, may worsen) matters over time because of unintended consequences; places a greater emphasis on understanding and improving relationships among the individual components of a problem; and seeks to focus on a few coordinated changes and leverage points, implemented over time to assure sustainability [ ] . a systems thinking approach can be useful in addressing complex issues in osh directly related to the fow as well as current osh issues that will carry forward. because of this, the european union has added systems thinking to the core competencies for the public health professional [ ] . in the u.s., schools of public health are shifting the traditional public health education paradigm to emphasize both systems thinking and interprofessionalism, which is defined as working with professionals outside the disciplines of public health and closely linked to transdisciplinarity [ , ] . to better understand interrelationships relevant to osh in fow and as an initial step towards affecting change, the following systemic questions should be considered: (a) who are the stakeholders and how might they view the issue? (b) what changes in systems structure (e.g., policies, practices, power dynamics, perceptions or mental models, purpose) can be proposed to help organizations address the issue? (c) what might be the unintended consequences of these proposed changes? these questions were considered in the context of three fow challenges that will impact osh: ( ) technology disruption-innovations that have significantly altered the way consumers, industries, and businesses operate; ( ) global competition-competing organizations serving international customers; and ( ) changing worker demographics-shifts in historic worker characteristics. several key stakeholder groups were identified as potentially impacted by challenges facing osh in the future in the areas of technology, globalization, and demographics. these stakeholder groups include employers; specific subgroups of workers such as immigrants and seasonal, older, and younger workers; unions; recruiters and other human resource professionals; the tech industry; unemployment agencies; policymakers; governmental agencies; share-and stockholders; academic institutions; consumers; and the general public. changing worker demographics challenge communication and training needs. challenges identified by technological disruption are brought on by innovations that have significantly altered the way consumers, industries, or businesses operate. global competition is challenged by competing organizations, a decline in unionization, cross-cultural issues including miscommunication and changing values, and disparities in health and equality across companies and populations. a summary of the small group discussions around proposed changes and possible unintended consequences for each current issue is provided in table . the following gaps and needs were identified related to integrating a systems thinking approach into training the next generation of osh professionals. systems thinking should be taught early on and as part of a core curriculum versus an on demand soft skill. it should be viewed as not only a purely cognitive skill but one that includes broader skill sets of facilitation, spiritual work, and emotional intelligence. interdisciplinary leadership and guidance will be important. public health tends to still look at cause and effect linearly, while a systems approach would encourage a big picture view that understands other perspectives. strong problem-solving skills will be needed to anticipate and adapt as change happens. issues related to the profile of the future osh professional were presented from an employer perspective, with particular emphasis on environmental health sciences in business, the realities of a more distributed and mobile workforce, and the need for alignment with non-osh professions. recognition of the need to address environmental health issues on a global scale is increasing within the business world [ ] . climate-related changes, such as extreme weather events, can have simultaneous effects on business operations and the surrounding community, creating a mutual dependence and responsibility for coordinated responses. company statements of purpose are now more likely to go beyond simply assuring returns to shareholders, incorporating commitments to stewardship, global sustainability, and duties to community [ ] . workforces are more distributed, oftentimes around the world, and increasingly mobile. the increase in the use of short-term contracts results in workers having an increased number of jobs over a lifetime, at times coupled with several changes in career paths. this raises important questions for companies in terms of retaining critical skills and institutional memory [ ] . potential solutions include hiring based more on desired skill sets than educational background and combining subject matter experts with an empowered workforce. additionally, the lines between work, home, and community are evermore blurred; and there is evidence that good health-including mental health-and happiness are drivers of productivity [ , ] . a significant challenge facing the osh field is the risk of being marginalized if it cannot embrace and adapt to fow, including how to deal with uncertainty. there are opportunities, but they will likely require important changes in how we educate the osh professionals. one important question for the osh community to consider includes how to best integrate the need for training in specific skills in osh and allied disciplines with the need for training in "softer" skills, including leadership, corporate culture, and well-being. additional challenges include how to manage the transactional/gig nature of the new workforce. how do we protect the institutional knowledge when people are working shorter periods in any one company? with shorter tenure and more rapid turnover, it becomes increasingly challenging to find ways to retain knowledge and transfer it to a new and changing workforce. another challenge that is not new to osh is developing strategies for how to "sell" or promote the value of osh to non-osh audiences. the attributes osh professionals of the future will need in order to combat these challenges and the strategies to foster development of such attributes are summarized in table . there is a need to incorporate multiple perspectives of different professions into osh training and integrate different disciplines to create a transdisciplinary approach to problem solving. osh professionals need greater interpersonal skills to help communicate up and down the line as well as translate across professions and stakeholder groups. the osh profession needs a balance of topical specialists and broadly trained health and safety generalists. all osh professionals need increased opportunities for cross-training and soft skills development. additionally, there is a need for greater problem recognition and problem-solving skills in osh that are transdisciplinary and anticipates new risks in the fow. the osh professional of the future needs to take a more holistic approach that brings several opportunities to engage leadership in the development of company/agency statements of purpose that goes beyond shareholders. interacting with finance and insurance systems will be necessary to support a healthy workforce. osh should pay attention to and anticipate new risks posed by different fow challenges. how the field responds to these challenges can help address the gradual marginalization of osh by creating a proactive rather than responsive profile. academic osh programs should develop new approaches and methods, creating opportunities for targeted and focused training that can be personalized. central to this is using a transdisciplinary perspective to incorporate multiple disciplines, professions, and technology into osh academic training. an area of curriculum that is missing from many mainstream osh training programs is the health and safety of the informal sector. these workers labor under precarious conditions with non-traditional exposures that are not well characterized nor understood. as reliance on this sector increases, the need for and expanded focus for osh to address this important part of the labor market increases as well. training programs should also integrate osh practice earlier in the degree pathway and re-engineer competency-based learning to achieve personalized learning objectives. developing modular or standardized training units that "fit" together as needed based on a menu-driven curriculum could serve to support both learner-centered specialty and core competencies without necessarily being based on the traditional formal degree pathway. for this to be successful, however, we must value and accept learning that occurs outside traditional academic degree programs and have a mechanism by which to evaluate and certify learning obtained with this approach. finally, regardless of the learning pathway, we must find ways to incorporate osh tenets earlier into the education and career decision-making process. responding to shifts in historic worker characteristics will create opportunities to change human resource practices and selection practices. unions and organized labor will need a more diverse representation of the changing worker demographics to continue to be a sustained voice for workers. managing innovations that have significantly altered the way consumers, industries, or businesses operate will be critical in the fow. new policies and practices will need to shift to accommodate increasing demand for flexible work arrangements, and research will be needed to fill knowledge gaps through a collaborative effort that creates a shared understanding of what motivates a given industry. combatting the unintended consequences of global competition including a decline in union power, cultural issues that result in changing values in work and life, and disparate health and equality between companies and people will require new and more legal protections, financial support systems to fund education, expanded health and retirement benefits, and harmonization of work standards and work-life fit. these recommendations will help develop a roadmap toward an expanded focus for osh, built on the traditional osh paradigm and the twh framework, to anticipate future education and training needs. a new approach to training osh professionals that anticipates changes the future of work will bring is a critical next step to developing systems that not only protect workers by preventing potential injury and illness but also promote worker well-being over the work-life continuum to optimize a productive and healthy life course. the conclusions and recommendations presented in this paper are based on the work of a limited number of subject matter experts. a majority of participants were from u.s. academic institutions with existing osh training programs, and their opinions may be influenced by existing academic paradigms that focus on osh issues of workers in the u.s. a small number of participants were from workshop participants: bethany alcauter, mph (workers' defense project cih (board for global ehs credentialing scd (cpwr the center for construction research and training well-being at work-overview and perspective a study of the extent and potential causes of alternative employment arrangements. ind. labor rev contingent workers and contingent health: risks of a modern economy government accountability office telecommuting will likely continue long after the pandemic potential scenarios and hazards in the work of the future: a systematic review of the peer-reviewed and gray literatures. ann. work expo. health . epub ahead of print uscher-pines, l. expanding the paradigm of occupational safety and health a new framework for worker well-being measuring well-being and progress: well-being research national institute for occupational safety and health [niosh]. niosh total worker health® future of work initiative advancing worker safety, health and well-being research methodologies for total worker health®: proceedings from a workshop the niosh future of work initiative and the total worker health®approach artificial intelligence and worker safety thinking in systems: a primer education and training to build capacity in total worker health®proposed competencies for an emerging field towards an expanded focus for occupational safety and health healthy workplaces: a model for action for employers, workers, policy-makers, and practitioners; world health organization sustainable work throughout the life course: national policies and strategies; publications office of the european union: luxembourg the niosh total worker health™ program: an overview emerging student needs disrupting higher education the future of learning and education the social psychology of organizations introduction to systems thinking aspher's european list of core competences for the public health professional accreditation criteria: schools of public health public health programs public health . : a call to action for public health to meet the challenges of the st century world economic forum. the global risks report transforming our world: the agenda for sustainable development number of jobs, labor market experience, and earnings growth: results from a national longitudinal survey summary mental health and productivity at work: does what you do matter? labour econ employer perspective on training of future osh/has professionals the authors thank the workshop speakers, participants, and organizing committee for their contributions to the discussion of challenges, gaps, and needs. the authors thank leslie hammer and lee newman for providing input into the final draft. the authors declare they have no conflict of interest. the findings and conclusions in this report are those of the authors and do not necessarily represent the views of the national institute for occupational safety and health. this appendix provides the names and affiliations of the workshop speakers, participants, and organizing committee. key: cord- -nu typ j authors: acuin, cecilia s; khor, geok lin; liabsuetrakul, tippawan; achadi, endang l; htay, thein thein; firestone, rebecca; bhutta, zulfiqar a title: maternal, neonatal, and child health in southeast asia: towards greater regional collaboration date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: nu typ j although maternal and child mortality are on the decline in southeast asia, there are still major disparities, and greater equity is key to achieve the millennium development goals. we used comparable cross-national data sources to document mortality trends from to and to assess major causes of maternal and child deaths. we present inequalities in intervention coverage by two common measures of wealth quintiles and rural or urban status. case studies of reduction in mortality in thailand and indonesia indicate the varying extents of success and point to some factors that accelerate progress. we developed a lives saved tool analysis for the region and for country subgroups to estimate deaths averted by cause and intervention. we identified three major patterns of maternal and child mortality reduction: early, rapid downward trends (brunei, singapore, malaysia, and thailand); initially high declines (sustained by vietnam but faltering in the philippines and indonesia); and high initial rates with a downward trend (laos, cambodia, and myanmar). economic development seems to provide an important context that should be coupled with broader health-system interventions. increasing coverage and consideration of the health-system context is needed, and regional support from the association of southeast asian nations can provide increased policy support to achieve maternal, neonatal, and child health goals. southeast asia has achieved substantial reductions in child and maternal mortality over the past two decades, but these achievements are unevenly distributed among and within the countries in the region. of the ten countries in the association of southeast asian nations (asean), only three have infant and child mortality rates below ten per livebirths-brunei, singapore, and malaysia. infant and under- mortality in thailand and vietnam have declined substantially to below per livebirths within the past two decades, but the philippines and indonesia have seen a levelling off in rates to between and per livebirths. myanmar, cambodia, and laos still have mortality levels of - per livebirths in , which are similar to the rates of their neighbours from more than two decades ago, and rank among the highest for asia. the un estimates that every year about women die as a result of pregnancy or childbirth, as do nearly million children younger than years. worldwide, in , about maternal and child deaths were in southeast asia. laos and cambodia are among seven countries with the highest maternal mortality ratios outside of sub-saharan africa, and indonesia is one of countries that account for % of all maternal deaths worldwide. although southeast asia as a region might achieve the reductions in child mortality set by the un millennium development goal (mdg ), cambodia and myanmar have been rated as having insuffi cient progress. declines in mortality rates in indonesia, laos, and the philippines are also faltering. similarly, although all countries in the region are reporting declines in maternal deaths (towards mdg ), the rates of decline for indonesia, the philippines, and myanmar have notably slowed. • southeast asia has sustained substantial reductions in maternal, neonatal, and child mortality since , but this progress has been uneven. mortality reductions in some countries have been the result of trajectories of rapid decline that started long before the millennium development goals (mdgs) were developed in . others have succeeded in improving progress since the s, but some countries continue to struggle. • causes of death suggest a mortality transition in maternal deaths in the region. child deaths are mainly attributable to the persistence of neonatal causes along with key preventable factors in the postneonatal period. • disparities in intervention coverage are most acute in countries with the lowest intervention coverage overall. • despite the variations in achievements, some countries are notable success stories. suggested key factors include the ability to link maternal, neonatal, and child health interventions to broader health-system investments and to target access to rural and disadvantaged populations. • increasing coverage to % will have a substantial eff ect on maternal deaths caused by unsafe abortion, hypertensive diseases, and postpartum haemorrhage and on neonatal deaths caused by pneumonia, sepsis, and birth asphyxia. although there might not be quick solutions for maternal, neonatal, and child health in the region, coordinated expansion of proven eff ective interventions can contribute to improved reductions in mortality. • there is a need for stronger regional cooperation through the association of southeast asian nations to provide support to countries that need to accelerate progress to meet the mdgs. southeast asia as a region has received little attention in recent eff orts to revitalise and strengthen the policy agenda of the partnership for maternal, newborn and child health, despite the complexity of national trends, including the substantial burden of morbidity and mortality in several countries and the existence of documented successes. as the economies of southeast asia become more integrated with each other, there is an increasing need to assess and resolve the defi ciencies in this agenda and to identify policy options for sustaining, if not accelerating, the pace of reduction in mortality. eff ective and aff ordable technology to reduce most maternal, neonatal, and child deaths is available, - so why has progress been so uneven? we focus on a region, collectively the ninth largest economy in the world, whose performance and achievements are often hidden by larger countries such as india or china, as well as by the un agency groupings of the region that do not take into account historical and geopolitical ties within southeast asia. in this paper, we critically review the region's achievements in reducing maternal and child mortality and highlight key factors that explain the successes and challenges in reaching these goals during competing worldwide, regional, and national health problems. we fi rst report on patterns of mortality reduction within southeast asia and major causes of maternal and child deaths in the context of mdg and mdg . we investigate two country cases to highlight the notable variations in mortality reduction. finally, we use an analysis of the deaths that could be averted through expanded coverage to identify more eff ective approaches for improving maternal, neonatal, and child health in southeast asia. for the ten countries discussed in this paper, we reviewed estimates from national data sources and country ministries of health, as well as from the demographic and health surveys and multiple indicator cluster surveys. we also reviewed estimates from international data sources from unicef, who, and the institute for health metrics and evaluation (webappendix pp - ). we present country-specifi c estimates on maternal, neonatal, and under- mortality rates from recent un mdg reports, , as these estimates enable cross-country comparisons on trends in mortality using replicable estimation methods that reduce sources of non-sampling error. these estimates tend to be more conservative in the rate of decline than estimates from the institute for health metrics and evaluation. on the basis of increasing awareness of the burden of neonatal mortality, we sought comparable estimates of trends that separated neonatal (death within the fi rst days after birth) and postneonatal (death between days and year after birth) mortality. as un models do not have neonatal time trends for all countries in the region, we report estimates from the institute for health metrics and evaluation. we report estimates on causes of neonatal and child deaths on the basis of standardised methods for estimating the distribution of causes of child deaths. we compiled estimates of causes of maternal deaths from countdown country reports and who. we evaluated data from the demographic and health surveys and multiple indicator cluster surveys , to assess existing intervention coverage within the region, with these data sources providing the ability to disaggregate coverage estimates by wealth quintile and rural or urban status [ ] [ ] [ ] [ ] to establish the country average of coverage and to assess the programme coverage in disadvantaged populations by economic status and geography. we calculated regional estimates using country-level data from the specifi c source cited, unless otherwise indicated. to test the contribution of health-sector inputs to mortality reductions, we selected thailand and indonesia as case studies, as high (thailand) and lower (indonesia) achievers, and we focused on maternal and neonatal mortality as outcomes sensitive to healthsystem development. we used national data for these case studies to extend the analysis to the period before see online for webappendix we searched the demographic and health surveys (cambodia and indonesia indonesia , indonesia , indonesia , indonesia - , and philippines philippines , philippines , philippines , and and vietnam and ) , multiple indicators cluster surveys, , data banks of regional and global fi nance institutions such as the asian development bank and the world bank, [ ] [ ] [ ] [ ] the millennium development goals surveillance data sources and publications of the un agencies, mainly unicef, , and who , , from to october, . we used the following search terms: "asia", "asia and pacifi c", "southeast asia", "sea", "association of southeast asian nations", and "asean" (for geographic location); "cambodia", "indonesia", "lao pdr", "laos", "malaysia", "myanmar", "philippines", "thailand", and "vietnam" (our countries of interest); "(maternal or child or neonatal) and (health or health care)", "(health or mortality) and (pregnancy or pregnant)", and "(health or mortality) and (maternal or neonatal or infant or child or under years" (for health conditions); "health systems", "health fi nancing", "leadership", "governance", "information systems", "delivery and organization of services", "regulation of health products", "human resources" (for health systems); "maternal mortality ratio", "infant mortality rate", "neonatal mortality rate", "under mortality rate", "skilled birth attendance", "antenatal care", "prenatal care", "immunization", "maternal and child nutrition", and "causes of maternal, infant and child mortality" (for mortality and health programme indicators); and "gross domestic product", "gdp", "gdp per capita", "national health accounts", "nha", "public and private health expenditures", and "(out-of-pocket or oop) health expenditures" (for fi nance). these data are complemented by nationally representative data and international journal publications. specifi c country data were further verifi ed and updated by members of the writing team. we also searched pubmed from to october, , for peer-reviewed journals for pertinent articles on maternal and child health and the region, and cross-referenced who, unicef, the world bank, and the asian development bank. no initial language exclusion was applied in searching; for full-text papers, english and the languages of the authors (thai, bahasa, malay, chinese, filipino, and burmese) were used. the mdg baseline year ( ). , we fi tted data to a quadratic equation: log mmr or log nmr=intercept+linear eff ect of year +quadratic eff ect of year and to a linear equation: log mmr or log nmr=intercept+linear eff ect of year to establish whether declines in maternal mortality could be attributed to programme changes or temporal trends, where mmr is the maternal mortality ratio and nmr is the neonatal mortality rate. using the lives saved tool (list), we calculated potential deaths that could be averted through increasing population coverage of the interventions proven to be eff ective in reducing maternal, neonatal, and child mortality. , list operates within the spectrum modelling platform, by the futures group, initially developed to project demographic change and complemented by modules to model the eff ect of family planning and hiv/aids interventions. the model yields estimates of deaths averted by cause and intervention for user-specifi ed intervention coverage levels, based on inputs of demographic projections, numbers of maternal and child deaths, data on the distribution of deaths by cause, intervention eff ectiveness, and data on local health status. , - the platform has been used previously for analysis of eff ect of intervention packages on maternal and child survival in south africa and sub-saharan africa, but this is one of the fi rst uses in southeast asia. for this analysis, we assessed all the maternal, neonatal, and child health interventions included in list. the interventions and the estimates of their eff ectiveness are provided in webappendix pp - . values for the eff ectiveness of interventions were developed through a standardised review process using established criteria to identify which interventions to include on the basis of levels of evidence. the analysis was done for all ten countries and then for three subgroups of countries on the basis of observed patterns of mortality reduction: subgroup (brunei, singapore, malaysia, thailand); subgroup (the philippines, indonesia, vietnam); and subgroup (laos, cambodia, myanmar). we assessed potential lives saved at three hypothetical coverage levels: %, %, and %. reductions in maternal, infant, and child mortality in southeast asia are indicative of the diversity of this region, presenting three divergent patterns (fi gure , data not shown for brunei and singapore as these countries are considered to be more developed and where mdg goals might not be as relevant). , the fi rst pattern refl ects countries achieving low rates of mortality between (the mdg baseline year) and in brunei, singapore, malaysia, and thailand. in , maternal mortality ratios in these countries were well below per livebirths, and infant and under- mortality rates were already at or below per livebirths. these countries, the most economically advanced in the region, have also invested in their health systems over time. a second, less distinct, pattern, seen in the philippines, indonesia, and vietnam, starts with relatively high mortality rates and ratios in , fairly large initial reductions (except for the maternal mortality ratio in indonesia) that somewhat faltered after in indonesia and the philippines. by contrast, there were accelerated reductions in mortality in vietnam during this period, with mortality rates and ratios beginning to come close to those of thailand. the third pattern, observed in laos, cambodia, and myanmar has very high levels at the beginning of , followed by sustained reductions from to , with the exception of cambodia's maternal mortality ratio. these three countries, which are on the un list of least developed countries, continue to report high rates of maternal, infant, and child mortality. plotting maternal mortality reductions against gross national income per capita (webappendix p ) indicates that, although countries with high maternal mortality achieved reductions in mortality as their gross national income per capita increased, some of the most notable declines in mortality took place earlier than the rapid rise in gross national income. the rapid reductions in maternal mortality in thailand occurred before . as maternal mortality declined to levels around , smaller reductions take place even as gross national income continues to improve. similar patterns are evident for infant and under- mortality versus gross national income per capita plots (webappendix pp - ). separating infant mortality reduction between and into neonatal and postneonatal (webappendix p ) indicates that the largest declines in infant mortality over time were mainly attributable to substantial postneonatal mortality reductions, as seen in malaysia, thailand, and vietnam. the philippines and indonesia had reductions in neonatal and postneonatal mortality similar to that in laos, cambodia, and myanmar. although starting with comparably lower baseline mortality levels in , rates of decline in the philippines and indonesia were not suffi ciently accelerated since the development of the mdgs. reductions in infant mortality in brunei and singapore stem from larger proportions of decline in neonatal deaths, a pattern similar to other high-income countries. other than brunei and singapore, the slower rates of decline for neonatal mortality for the other eight of the ten asean countries is a cause for concern. interventions for reducing neonatal mortality are more closely linked to maternal interventions in terms of policy and programme implementation and might not be as noticeably tracked towards their eff ect on under- mortality. the philippines, which is deemed to be on target for mdg in achieving reductions in child mortality, has the lowest reduction in neonatal mortality in the region-lower than that for cambodia or myanmar, which have been identifi ed as having insuffi cient progress towards achieving mdg . the distribution of maternal mortality causes (fi gure a) is indicative of the substantial variations in health status and health-system development seen within the region. haemorrhage is a leading cause of death, probably indicative of delays in attaining emergency obstetric care. hypertensive disorders contribute to about one in every six maternal deaths in southeast asia and suggest a diff erent causal pathway more similar to that in developed country settings. the proportion of other indirect causes might indicate the still-substantial burden of infectious disease within the region and the eff ect of malaria and hiv on maternal health. unsafe abortion is a factor in almost % of maternal deaths. these patterns refl ect a causal transition in maternal mortality as the overall risk of maternal death declines and these causes will aff ect the extent to which interventions, both as single modalities or included in a package, can be predicted to avert deaths. diff erent rates of reduction in child mortality can be attributed partly to variations in causes of death (fi gure b). neonatal problems, such as preterm complications, contributed to about % of child mortality, accounting for the single largest proportion of preventable deaths, even as several asean countries are successfully reducing their postneonatal and child mortality burdens. infectious diseases, including pneumonia and diarrhoea, still account for almost half of the deaths in children, indicating substantial scope for continued reductions in child mortality. inequalities are substantial across countries in the region, but also within countries, as indicated by the current variation in intervention coverage by income and by rural or urban subgroups (webappendix pp [ ] [ ] [ ] . disparities exist in antenatal care coverage, use of skilled birth attendance, and diphtheria, polio, tetanus, and measles vaccination together with use of oral rehydration therapy, which are all key to the development of a continuum of care. , with regard to overall programme coverage, laos has a substantially lower coverage than that of other countries in the region and is far from a % coverage level, even for the wealthier groups. antenatal care coverage is the most widespread, being close to or above %, in countries other than laos and cambodia, for the wealthier and urban areas. this disparity suggests that there is scope to eff ectively increase prenatal interventions that can avert maternal deaths. vaccination coverage varies widely between and within countries, although several countries in the region are eligible for funds from the global alliance for vaccines and immunisation and have received substantial fi nancial and policy support that is likely to lead to increases in vaccination coverage over time. laos and cambodia have the greatest disparities in programme coverage. in cambodia, vaccination levels for the wealthiest quintile are similar to those of the other southeast asia countries, matching those of indonesia's highest quintile. however, the coverage in the poorest households in cambodia is almost % lower than that for the wealthiest households, resulting in a large equity gap in immunisation levels. the countries shown in the fi gures in webappendix pp - indicate relatively low coverage of skilled birth attendance (except thailand and vietnam) with inequality particularly acute in the philippines, laos, and cambodia. diff erences in skilled birth attendance between urban and rural laotian populations are the largest among the six countries included in this comparison. skilled birth attendance could be viewed as one indicator of broader health-system development, and the generally low coverage coupled with a high extent of inequality highlights the need for more comprehensive and coordinated health system improvements in the region overall. these patterns also point to the necessity of targeting the most vulnerable populations and maintaining attention to equity while increasing programme coverage. to understand potential determinants of mortality reduction, we look in more depth at two countries with diff erent experiences of lowering mortality. the reduction in the maternal mortality in thailand began in the s (webappendix p ) at a time when skilled birth attendants, mostly midwives, were systematically trained and deployed to community hospitals. [ ] [ ] [ ] at the time of alma-ata in , thailand's maternal mortality ratio was already below and continued to drop even further in the s as the economy improved and a health-care insurance programme for low-income populations was introduced along with specifi c safe motherhood interventions. another round of health-system reforms and maternal, neonatal, and child health interventions were introduced in the early s, including universal health coverage. coordinated health policy support through successive national plans provided a context and investments to stimulate structural, fi nancial, and social capacities to deliver services, particularly in the district health system. , , mandatory rural service for medical graduates provided a stable human resource base within community hospitals. using a log linear model, no single programme could explain the decline in maternal mortality between and , suggesting that the accelerated decline might be attributable to several developments. however, model fi t after the economic crisis was not as good compared with earlier time periods. there was an data for maternal deaths are from un mdg southeast asia, , including from ten asean countries and timor leste (data not broken down to country level). data for child deaths are from black et al. increase in maternal mortality from to , followed by a steady decline. this decline was in parallel with economic recovery and the introduction of universal health insurance coverage, the provincial maternal and child health board groups, the healthy thailand programme, and the saiyairak programme. , , for this short period, assessment of the eff ect of any intervention programmes is diffi cult. the systematic deployment of community-based health personnel took place in indonesia about a decade later than in thailand in the s. major, targeted, safe motherhood initiatives were introduced in the late s, but by that time the maternal mortality ratio of indonesia was about nine times higher than that of thailand (webappendix pp - ). , a village midwife programme was implemented between and , but the comparatively rapid training and deployment of village midwives might have compromised quality of care. access to care in indonesia varies by rural or urban geography, income, and level of education. unlike in thailand, where the provision of skilled birth attendants was followed by increased facility and referral level capacities, in indonesia not all health centres can provide basic obstetric care. about % of district hospitals do not have an obstetrician, indicating limited provision of the -h continuum of care necessary for dealing with emergency situations. a fragmented and devolved health system has challenged the capacity to sustain a comprehensive and concerted focus on maternal and child health. reductions in neonatal mortality (webappendix p ) for the two countries mirror reductions in maternal mortality. interventions to reduce neonatal mortality need more from health systems than either a maternal or child programme alone. in thailand, neonatal interventions have been linked with maternal programmes, , , but this association has not been documented in indonesia. maternal and neonatal mortality reductions in thailand and indonesia occurred in the context of rapid economic growth in both settings along with widespread increases in education levels and in sex equity. although these factors might have aff ected levels of success, other determinants of mortality have been involved. policy implementation in thailand has been multi-sectoral, involving royalty and diff erent ministries, including the national health security offi ce, which is responsible for health fi nancing, especially universal coverage of health insurance. investments in primary health care in the s have led to benefi ts in the long term. however, geographic and demographic context also probably have a role. at the time of its rapid maternal mortality reduction in the s, thailand had a smaller, more circumscribed population compared with the larger and more dispersed indonesian population, and this diff erence might have been an important factor in establishing physical access-a basic requirement for programme coverage. we investigated the potential eff ects of expanding programme coverage through a list analysis of the asean region as a whole, and for subgroups on the basis of the mortality reduction patterns described earlier. we provide percentages rather than absolute numbers, as these estimates should be interpreted with caution in the context of local data. the list analysis is under development as a measure for assessing and evaluating the benefi ts and limitations of interventions. several of the interventions cited and used have been recently reviewed in depth , and used for regional estimates. , these estimates are the best point estimates for the eff ect of interventions, and, although these have been validated against actual observed mortality eff ects in the neonatal period, they still need prospective validation for programme-based eff ectiveness. asean regional averages are closer to those of subgroups and (as defi ned earlier), which consist of the bulk of the population and the higher mortality rates (fi gure a). although diff erences in maternal deaths averted across the groups are substantial, common trends across the region highlight crucial gaps. expanding coverage of interventions for hypertensive disease in pregnancy and safe management of abortions, for example, will reduce maternal deaths substantially throughout the region, and addressing postpartum haemorrhage causes will largely reduce deaths for subgroups and but not subgroup . counterpart calculations were made for neonatal and child mortality (fi gure b and c). interventions for birth asphyxia are more likely to avert deaths in subgroups and than in subgroup . the high proportion of neonatal and child deaths averted through interventions for infectious diseases in all subgroups is indicative that infectious disease remains a challenge for the region as a whole. , to focus on universal coverage, which is receiving greater attention in other health-policy settings, we report the deaths that could be averted at % programme coverage. at the regional level, universal basic obstetric care coverage will save about one in fi ve mothers (table) , but with universal comprehensive obstetric care coverage, more than half of maternal deaths would be averted. almost all these lives saved would be in subgroups and for which current levels of coverage for these services are low (webappendix pp [ ] [ ] [ ] . because there is already good access to basic and comprehensive obstetric care for subgroup , the deaths averted from these interventions are minimal. by contrast, basic postabortion case management will save a higher proportion of mothers in subgroup but more deaths will actually be averted in subgroups and . the fewer lives saved in subgroup with comprehensive abortion versus basic abortion care might be because the access to comprehensive obstetric care that could be used for abortion management in this group is already high. universal basic obstetric care will avert about one in fi ve neonatal deaths in subgroup , whereas comprehensive obstetric care will save almost twice as many lives as basic care will for the region as a whole, but particularly for subgroups and . however, even at % coverage the maximum proportion of neonates that could be saved with either of these interventions does not go beyond a third of deaths, indicating the need for other interventions such as those that take into account prematurity through antenatal steroids and providing kangaroo care. interventions directed towards infectious diseases such as diarrhoea and pneumonia will, likewise, aff ect postneonatal and child deaths mostly in subgroups and . a small but noticeable eff ect on death in subgroup might also be apparent when coverage increases to %. preventive measures such as improving access to safe water can contribute substantially to mortality reduction, averting more deaths than would pneumococcal vaccination in all the subgroups. despite substantial improvements in maternal, neonatal, and child health since , most notably in malaysia, thailand, and vietnam, high mortality, poor coverage, and high inequity continue to challenge other countries in the region, such as laos, cambodia, and myanmar. improvements in the fi rst three countries seem to be attributable to socioeconomic progress and a consistent policy focus on maternal and child health programmes and coordinated health-system components, [ ] [ ] [ ] notably a stable and strategically deployed health workforce coupled with supportive fi nance mechanisms in malaysia and thailand. the importance of favourable health systems is highlighted by the case study in thailand, which indicates that mortality reductions have taken place at modest levels of economic growth and that no single factor or intervention could account for these reductions. the case study in indonesia indicates how similar interventions used in a setting with diff erent system capacities and geopolitical features can result in diff erent outcomes. thus, although the list analysis can estimate the potential eff ect of interventions given with maximum levels of coverage, the case studies caution us that improving health outcomes is not just about increasing the amount of money spent on health. instead, targeted and sustained interventions to reduce the barriers that prevent the most vulnerable population groups from accessing the interventions they crucially need should be ensured in the long term. for example, the list analysis indicates that providing basic and comprehensive emergency obstetric care has the potential to avert half of all maternal deaths and about one in six neonatal deaths in laos, cambodia, and myanmar. however, prevention of these deaths might be possible only if care coverage is rapidly expanded in low-income and rural populations, possibly through sustained donor investments, given the low levels of domestic health spending. in the philippines and indonesia, the two most populous countries in the region, regaining momentum in mortality reduction alongside substantial geographic and cultural access challenges might mean improving access to services through more equitable fi nancing schemes. despite the varying agendas that countries of the region might need to adopt to complete the unfi nished maternal, neonatal, and child health agenda, our fi ndings indicate important areas of common ground. many key interventions to reduce child deaths have been implemented at the community level throughout southeast asia, but necessary health-service investments that will enable the countries of the region to reduce maternal and neonatal deaths have yet to be fully considered. access to safe abortion services and management of hypertensive disorders during pregnancy will prevent maternal deaths from these causes from brunei to myanmar. similarly, all countries in the region recognise space for expanding coverage of crucial neonatal interventions to prevent preterm births and neonatal deaths from infection. our study has several limitations. we have used estimates of mortality reduction from un agencies that might not match national estimates and that use diff erent methods; however, these estimates are preferred for cross-country analysis. these estimates for southeast asia are still mainly derived from household surveys and subject to potential error from under-reporting and misclassifi cation of deaths. only fi ve of the ten countries discussed have vital registration systems, and not all these systems have valid registration of causes of death. there is an acute need for better data in laos and myanmar, particularly on maternal mortality, but the pioneering work in maternal death audits in malaysia provides a potential model for the region. the selection of data sources was mainly aff ected by the availability of comparable, reliable data across all the asean countries. for example, although we used the more inclusive gross national income per capita for webappendix pp - , this measurement was not consistently available for the case studies, hence the use of gross domestic product for thailand and indonesia. we were not able to disaggregate list estimates into relevant national subgroups by wealth or by rural or urban status. this non-separation is important because the poor populations are likely to have higher mortality rates and lower levels of intervention coverage than the wealthier groups, which could aff ect estimates. data limitations restricted our ability to develop this analysis, even as a test case. we have also not analysed the costs involved in extending coverage, which we hope to develop in a future study. since its formation in , asean has positioned itself as an important hub for economic and sociocultural cooperation. infectious diseases have thus far commanded much of asean's attention in health matters. recently, regional focus has begun to shift to other health issues. the asean strategic framework on health development - , which focuses on access to health-care services in addition to communicable diseases and pandemic preparedness, has also gained regional support. given the economic vigour of asean, regional cooperation in health might be key to motivating lessdeveloped members to focus on maternal, neonatal, and child health. the pivotal role of asean in stimulating and channelling international fi nancial aid to tsunami-devastated indonesia in and cyclonestricken myanmar in testifi es to the power of this promise-the goodwill and experience of working with each other in disaster situations can be harnessed for the health and wellbeing of mothers and children in the region. , but how should this aid be used? the experience of the asean, as discussed in this paper, suggests that eff ective interventions to curb maternal and child mortality need to be deployed to actively target the disadvantaged populations who are most aff ected by unsafe abortion, hypertensive diseases, postpartum haemorrhage, pneumonia, sepsis, and birth asphyxia. far from expecting coverage of these programmes to passively diff use to the very poor, governments must innovatively combine health interventions with non-health programmes such as micro-fi nance schemes and conditional cash transfer mechanisms that have proven successful in other settings. , achievement of the mdgs worldwide will not happen without individual country eff orts. as the donor community focuses its attention on the burdens of africa and south asia, asean countries must provide support to each other. examples of such support mechanisms already in place include fi nancial cooperation through the asean surveillance process, which is an early warning system to keep track of macroeconomic trends and to provide early detection of any adverse development. for public health, the asean sars containment information network exemplifi es how member countries share essential information, best practices, and new fi ndings for severe acute respiratory syndrome. however, asean has yet to develop initiatives for maternal, neonatal, and child health, which could be developed through sharing information and best practices (possibly starting by resolving the absence of comparable data across countries); fi nancial cooperation eff orts could be linked to outcomes, and the attainment of mdgs for member countries behind target could be made an asean priority. csa, rf, glk, tth, tl, and ea contributed to the conception, design, and acquisition of data for the fi rst draft. tl, ea, and glk contributed to the acquisition, analysis, and interpretation of data for the case studies. zb, rf, and csa contributed to the acquisition, analysis, and interpretation of data for the list analysis. csa and rf were responsible for the overall analysis and interpretation of data. all authors contributed to the drafting and critical review of the paper. csa is employed by the university of the philippines, national institutes of health and has received consultancy fees from projects with the philippine government, unicef, united states agency for international development, and who regional offi ce for the western pacifi c. glk has received consultancy fees from the institute of gerontology, universiti putra malaysia, international life sciences institute sea, seameo tropmed regional centre for community nutrition, and is employed by the international medical university, malaysia. all other authors have no confl icts of interest. geneva: world health organization trends in maternal mortality: - . geneva: world health organization estimates developed by the un inter-agency group for child mortality estimation countdown to . maternal, newborn and child health. country profi les years after alma-ata: has primary health care worked in countries? strategies for reducing maternal mortality: getting on with what works lancet neonatal survival steering team. evidencebased, cost-eff ective interventions: how many newborn babies can we save? continuum of care for maternal, newborn, and child health: from slogan to service delivery interventions to address maternal, newborn, and child survival: what diff erence can integrated primary health care strategies make? health and health-care systems in southeast asia: diversity and transitions neonatal, postnatal, childhood, and under- -mortality for countries, - : a systematic analysis of progress towards millennium development goal global, regional, and national causes of child mortality in : a systematic analysis van look pfa. who analysis of causes of maternal death: a systematic review demographic and health surveys multiple indicator cluster surveys monitoring the situation of children and women. thailand multiple indicator cluster survey socio-economic diff erences in health, nutrition, and population in cambodia socio-economic diff erences in health, nutrition, and population in indonesia socio-economic diff erences in health, nutrition, and population in the philippines socio-economic diff erences in health, nutrition, and population in vietnam bangkok: the war veterans organization of thailand printing press ministry of health, indonesia. national health surveys the lives saved tool. a computer program for making child and maternal survival projections list: the lives saved toolan evidence-based tool for estimating intervention impact spectrum: a model platform for linking impact of maternal and child survival intervention with aids, family planning and demographic projections the bellagio child survival study group. how many child deaths can we prevent this year? for the maternal and child undernutrition study group. what works? interventions for maternal and child undernutrition and survival the child health epidemiology reference group reviews of the eff ectiveness of interventions to reduce maternal, neonatal and child mortality saving the lives of south africa's mothers, babies, and children: can the health system deliver? sub-saharan africa's mothers, newborns, and children: how many lives could be saved with targeted health interventions cherg review groups on intervention eff ects. standards for cherg reviews of intervention eff ects on child survival world development indicators database a systematic analysis of progress towards millennium development goal lancet neonatal survival steering team. million neonatal deaths: when? where? why? mind the gap: equity and trends in coverage of maternal, newborn and child health services in countdown countries community fi nancing: thailand experience of blind alleys and things that have worked: history's lessons on reducing maternal mortality bureau of policy and strategy, ministry of public health. health policy in thailand. nonthaburi: ministry of public health health insurance systems in thailand. nonthaburi: health system research institute improving maternal, newborn and child health in the south-east asia region. data source: basic indicators: health situation in south-east asia, world health organization evolution of safe-motherhood policies in indonesia. initiative for maternal mortality programme assessment (immpact) increased educational attainment and its eff ects on child mortality in countries between and : a systematic analysis commentary: list: using epidemiology to guide child survival policymaking and programming list as a catalyst in program planning: experiences from burkina faso, ghana and malawi comparing modelled to measured mortality reductions: applying the lives saved tool to evaluation data from the accelerated child survival programme in west africa emerging infectious diseases in southeast asia: regional challenges to control health-fi nancing reforms in southeast asia: challenges in achieving universal coverage global report on preterm birth and stillbirth equity in maternal and child health in thailand united nations development programme measuring health systems performance in vietnam: results from eight provincial health systems assessments strategy for reducing maternal mortality association of southeast asian nations. joint statement of the th asean health ministers meeting singapore asean regional programme for disaster management. a regional strategy for disaster reduction tripartite core group; the government of the union of myanmar, the united nations, and the association of southeast asian nations. post-nargis joint assessment (ponja) health microinsurance: a comparative study of three examples in bangladesh. good and bad practices conditional cash transfers: reducing present and future poverty this paper is part of a series funded by the china medical board, rockefeller foundation, and atlantic philanthropies. the authors thank the following individuals for their assistance: virasakdi key: cord- -wif te w authors: hoffman, david a title: increasing access to care: telehealth during covid- date: - - journal: j law biosci doi: . /jlb/lsaa sha: doc_id: cord_uid: wif te w the covid- public health emergency has amplified both the potential value and the challenges with health care providers deploying telehealth solutions. as people across the country find ways to stay at home, telehealth preserves an opportunity to obtain necessary healthcare services. further, telehealth can help individuals avoid covid- infection, free up hospital beds and other resources for those patients most in need and prevent infected individuals from spreading that infection. federal and state regulators have recognized this potential of telehealth and have quickly changed a variety of laws and regulations to enable health care providers to deploy solutions quickly. these changes can provide lasting benefits for the use of telehealth well after the current crisis. however, to best realize telehealth’s benefits further legal and regulatory action are necessary. specifically, lawmakers and regulators should focus on six areas: reimbursement, privacy/cybersecurity, liability, licensure, technology access, and ai. increasing access to care: telehealth during covid- across the united states as we encourage everyone to stay home, telehealth provides an opportunity to reduce the visits to doctors' offices and hospitals. these reduced visits protect against covid- patients infecting others (particularly health care workers) and help protect patients with other medical issues from infection. additionally, telehealth services create the potential to release patients earlier from the hospital, and to avoid new hospital visits, which potentially frees up hospital beds and equipment for those patients who most need them. as we increasingly see outbreaks of infection in post-acute congruent living facilities such as assisted living centers and retirement communities, telehealth can and should be used to protect their elderly and other high risk residents. another benefit of telemedicine, the need for which has increased during this emergency, is to provide health care for communities which have limited access to needed services. these communities often include rural and underserved urban areas that may have limited internet broadband service and whose residents may have less access to other telehealth technologies such as a smartphone. these underserved communities may often need to rely on voice only telehealth services. telehealth is at least as old as the invention of the radio and the telephone. medicare has actually reimbursed for some telehealth services for over twenty years. there have been periods of health care providers advancing use of these services, but always followed by a waning period due to lack of proper incentives and challenges with interoperability. recent advances in broadband internet access, internet of things devices, electronic health records, and advanced data analytics have created a surge in both interest in, the capability, and the cost efficiency of telehealth services. the current public health emergency necessitates a detailed look at the federal and state telehealth regulations to determine what changes will properly incentivize rapid adoption of the technology while also mitigating concerns related to safety, privacy, cybersecurity, and how best to assist underserved communities and people. telehealth is a broad set of services that includes telemedicine delivery of clinical care as well as other non-clinical activities such as provider training, administrative meetings, and continuing medical education. the american telemedicine association (the ata) defines the increasing access to care: telehealth during covid- subset of telehealth referred to as telemedicine as "a health care provider's provision of services to a patient using telecommunications technology, where the patient and provider are in different locations". one particularly important category of telehealth services, which is often treated separately by regulators, is remote patient monitoring (rpm). the ata defines rpm as "including home telehealth, uses devices to remotely collect and send data to a home health agency or a remote diagnostic testing facility (rdtf) for interpretation. such applications might include a specific vital sign, such as blood glucose or heart ecg or a variety of indicators for homebound consumers. such services can be used to supplement the use of visiting nurses." telehealth services are often divided into three separate categories: synchronous, asynchronous and rpm. synchronous services allow for direct engagement between a health care provider and the patient using phone, video, or data transmission such as texting. asynchronous services allow patients and health care providers to store information and forward to the other party with an expectation that they will hear back at some point in the future. delivery of photos for examination is particularly effective in asynchronous services. rpm allows for a mix of both synchronous and asynchronous communication to allow health care providers to evaluate a patient's progress over time. hhs conducted a study that demonstrated that health care providers across many specialties were using these services even before the current crisis. telehealth, and especially rpm, has the potential to increase the number of health care providers by recruiting retired doctors and nurses who may have valid reasons not to want to work face to face with a patient (a compromised immune system or an injury that prevents the physical work that a hospital often requires), but who would like to put their skills and experience to use. additionally, the data that telehealth implementations create can be of tremendous value to public health agencies and health researchers. this paper focuses on six categories of public policy barriers to the implementation of telehealth: reimbursement, privacy/cybersecurity, liability, licensure, technology access, and ai. reimbursement -one of the most impactful barriers to the implementation of telehealth solutions has been whether the amount allowed for payment is enough to create an economic incentive for doctors (especially given the current demands on doctors' and their staff's time), and for system integrators and device manufacturers to develop the technology. cms has made great progress in recent months in providing for greater reimbursement for medicare patients by making a number of changes that apply for the duration of the current emergency. these changes allow healthcare providers to now bill for the following telehealth services:  initial and subsequent observation and observation discharge day management  audio-only telephone services for certain services  initial hospital care and hospital discharge day management  initial nursing facility visits, all levels (low, moderate, and high complexity) and nursing facility discharge day management  critical care services  domiciliary, rest home, or custodial care services, new and established patients  home visits, new and established patient, all levels  inpatient neonatal and pediatric critical care, initial and subsequent  initial and continuing intensive care services  care planning for patients with cognitive impairment  psychological and neuropsychological testing  therapy services, physical and occupational therapy, all levels  radiation treatment management services  licensed clinical social worker services, clinical psychologist services, physical therapy services, occupational therapist services, and speech language pathology services can be paid for as medicare telehealth services taken together these reimbursement changes allow for provider compensation for a broad set of telehealth services potentially at lower cost than in-person care. the experience in other countries supports the conclusion that reimbursement changes can significantly increase the potential of health care providers investing in the tools, processes, and training necessary to effectively provide services during the current crisis. for example, when france changed its reimbursement policies, they originally expected . million virtual care consultations for , but recent data suggests they may see in excess of million visits by the end of the year. increasing access to care: telehealth during covid- cms also will now provide for reimbursement for rpm services for acute conditions as well as chronic, and that expansion will extend beyond the public health emergency. this change can enable remote monitoring of those exhibiting symptoms of covid- and has potential to allow for earlier release from the hospital for patients freeing up beds for those who have more serious needs. health care providers can now perform rpm services when the caregiver is not located in the same physical location as the doctor. this change allows for new business models employing nurses and other health care providers who may have concerns or challenges with working in the doctor's office. other significant cms changes include permitting rpm services for new as well as existing patients, and that rpm providers will only need to obtain patient consent once per year. reimbursement proposals -while cms has made many changes to medicare reimbursement to encourage the use of telehealth during the public health emergency, there are further changes that can be made, especially in the area of rpm. even with the recent changes there are still low limits to the amount of time allowed for rpm and the amount allowed to be billed. these limits will discourage providers from offering services that could greatly assist patients, reduce risk during the crisis, and over time lower healthcare costs. recent cms changes only allow for two -minute rpm sessions to be billed per month at a national average of $ . to effectively allow for rpm management of covid- symptoms (particularly pulse oximeter readings), cms should allow for a greater amount of monthly time and an increased billing rate. also, currently only a primary care physician or a specialist is allowed to bill for rpm in any particular month. coverage should be expanded to allow for the primary care physician and multiple specialists to each bill as they may be monitoring different illnesses, such as diabetes and covid- . cms should also allow for reimbursement for the cost of the devices that need to be used by the patient for rpm. there are restrictions on rpm services that do not allow certain organizations to bill medicare. cms should immediately allow federally qualified health centers (fqhc), rural health centers (rhss), and home health agencies to bill for rpm services. also, given the current issues of covid- infection in congruent living facilities such as nursing homes and rehabilitation centers, cms should follow up on the expansion of medicare coverage for rpm from chronic to acute and further expand it to post-acute care. billing should be allowed for multiple rpm sessions a day for post-acute care. this change for post-acute rpm services will assist patients to return to their homes earlier and reduce risks to themselves and others. to aid in that goal, cms should allow for reimbursement for provider telehealth visits with family caregivers. if increasing access to care: telehealth during covid- these changes are collectively made, it will allow families to better care for their loved ones in their homes. hhs should also explore changes that will assist patients and providers to better use the technology and to navigate the often-difficult billing codes and processes. hhs should provide operational guidance to medicare administrative contractors (macs) for claims processing/billing requirements for expanded telehealth services. this should include guidance for rhcs and fqhcs. also, many telehealth services still require video for cms to provide for reimbursement. this video requirement may substantially limit the use of these services by underserved populations who do not have access to a smartphone or broadband internet. cms should look to expand reimbursement coverage for telehealth audio only services. audio only services will allow individuals who are most comfortable with talking on the phone to have meaningful discussions with their providers, and to reduce the need for broadband internet access. this change will be particularly helpful during the current crisis as it will reduce logistical challenges of sending new devices to patients and educating them on how to use the technology. the current emergency also should encourage cms to look at reimbursing for new healthcare services that hospitals are currently struggling to provide. specifically, medicare beneficiaries should be able to access respiratory therapy services necessary for their recovery via telehealth and remote monitoring solutions. these services should not be limited just to covid- patients. ii. privacy/cybersecurity -telehealth creates new cybersecurity and privacy risks as the patient's home may not have the same protections in place as a provider's office. telehealth also creates new opportunities for health information sharing that have privacy and security implications. understanding what further cybersecurity and privacy regulatory changes need to be made requires an overview of the current regulatory environment. the u.s. has a long-established regulatory framework for protecting the privacy and cybersecurity of health data. that framework is primarily composed of the health insurance portability and accountability act of (hipaa) ,the hipaa privacy rule and the hipaa security rule. in , congress passed the st century cures act to promote interoperability of electronic health records and to allow the patient to control the sharing of their personal health information. on march , , onc published the cures act final rule, which implements the interoperability provisions of the st century cures act to promote patient control over their own health information while protecting privacy and cybersecurity. this increasing access to care: telehealth during covid- rule makes many needed changes and has potential to greatly increase patient access to their health records, and hhs now needs to take steps to increase the speed of implementation. within hhs, ocr enforces the security and privacy rules. ocr has provided a number of useful clarifications and changes to increase the use of telehealth during the emergency. these following clarifications to encourage greater health information sharing specifically will be important to further the adoption of telehealth services that often require multiple providers, tools, and business associates. interoperability -while the cures act final rule was just published on march th , cms quickly determined that the deadline for compliance of january , , may be unreasonable given the covid- resource strain. interoperability presents practical systems development challenges that if addressed poorly can create significant cybersecurity and privacy issues. as a result, cms and onc delayed the requirement for compliance with many of the requirements of the rule. patient consent -ocr reiterated that hipaa was intended to allow for sharing of information without the consent of the patient as necessary to treat the patient or another patient. for the current crisis the sharing of clinical information may be impactful for the treatment of other patients. to mitigate privacy concerns, it is important to educate providers and the public that this form of health information sharing is necessary. the california consumer privacy act has brought considerable attention to the concept that individuals should be able to control their personal data, even while exempting hipaa covered phi from its requirements. at the same time, many privacy experts argue in favor of moving away from an exclusive focus on consent to enable sharing of information that is better for the individual and society. as covid- contact tracing efforts bring more attention to privacy , it will be important to avoid a public backlash against health information sharing by hhs communicating to the public the importance of the exceptions to consent requirements. hhs has also gone further to give providers latitude for information sharing during the crisis. on march , , hhs made a waiver for up to hours from the time the hospital implements its disaster protocol that covered hospitals would not be sanctioned for failure to comply with five provisions of the hipaa telemedicine cybersecurity -physicians have restricted the technology they have used for telehealth to remain compliant the hipaa security rule. ocr's february of notification states that covered entities and business associates need to continue to comply with obligations to properly provide cybersecurity protections for phi. the notification says: "in an emergency situation, covered entities must continue to implement reasonable safeguards to protect patient information against intentional or unintentional impermissible uses and disclosures. further, covered entities (and their business associates) must apply the administrative, physical, and technical safeguards of the hipaa security rule to electronic protected health information." however, in a march , , notification ocr stated: "during the covid- national emergency, which also constitutes a nationwide public health emergency, covered health care providers subject to the hipaa rules may seek to communicate with patients, and provide telehealth services, through remote communications technologies. some of these technologies, and the manner in which they are used by hipaa covered health care providers, may not fully comply with the requirements of the hipaa rules. ocr will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the hipaa rules against covered health care providers in connection with the good faith provision of telehealth during the covid- nationwide public health emergency. this notification is effective immediately." this added flexibility is not limited to just covid- patients and should provide physicians the ability to use common technologies like texting to greatly increase their communications with patients. including apple facetime, facebook messenger video chat, google hangouts video, zoom, or skype, to provide telehealth without risk that ocr might seek to impose a penalty for noncompliance with the hipaa rules related to the good faith provision of telehealth during the covid- nationwide public health emergency. providers are encouraged to notify patients that these third-party applications potentially introduce privacy risks, and providers should enable all available encryption and privacy modes when using such applications." as ocr allows for a greater selection of devices for telehealth, there will be an increased need to educate providers on how to increase their level of cybersecurity. one project that will help with this is the national institute of technology and standards' (nist) effort to increase cybersecurity in telehealth. nist's national cybersecurity center of excellence (nccoe) is conducting the securing telehealth remote patient monitoring ecosystem project , which will use the nist cybersecurity framework to apply a risk assessment methodology to develop a specific telehealth nist cybersecurity practice guide. business associate information sharing -telehealth experts have expressed concern that provisions of hipaa may restrict entities that fall under the "business associate" definition from sharing information with public health authorities, first responders and law enforcement. as many telehealth providers may fall under this definition, there was a need to remove this regulatory concern. on april nd , ocr provided notice that it will exercise its enforcement "discretion and will not impose penalties for violations of certain provisions of the hipaa privacy rule against health care providers or their business associates for the good faith uses and disclosures of phi by business associates for public health and health oversight activities during the covid- nationwide public health emergency." privacy/cybersecurity proposals -allowing broadly used technologies for telehealth is an important way to ramp the use of these services during the emergency. after the u.s. moves beyond the emergency it will be important to study the privacy and cybersecurity risks of using these general commercial platforms for telehealth. for example, congress, hhs, and state regulators should fund study of how health data obtained by the companies providing these platforms may have been commercialized and or transferred to other entities such as data brokers and online advertising providers. also, congress should provide increased funding for nist's securing telehealth remote patient monitoring ecosystem project and other methods to increase the use of the nist cybersecurity framework by telehealth providers. the use of new telehealth technologies and services does create the potential for increased privacy and cybersecurity risks, as it expands the footprint for cybersecurity attack to the use of new hardware and software, and outside of the providers information technology network. however, some of the existing restrictions that are intended to protect against these risks do not make sense in the current environment. for example, while ocr removed the risk of enforcement for sharing business associate information with public health authorities, there are still concerns that the contracts between hipaa covered entities and their business associates may restrict the sharing of this information. congress should put in place a legislative change to make these contract provisions unenforceable, and to create an obligation for sharing with public health authorities and approved researchers. this legislative change should also require the approved researchers to put measures in place to make certain the data is only used for health care research and not for data mining or other commercialization of the information. given that the onc interoperability rule under the st century cures act final rule was just published in march it is not surprising that there is still considerable work to be done to realize interoperability of electronic health records. the onc rule calls for providers and medical device developers to promote patient data access using third-party apps and application programming interfaces (apis) to share information between providers and among the different electronic health record vendors. improved sharing of electronic health records has the potential to greatly benefit telehealth, and specifically rpm. ocr should fund a study for how to best incentivize the implementation of the apis, and for how patients can most efficiently decide to share telehealth information with new health care providers. telehealth also involves the use and sharing of information by entities that will not fall under hipaa's scope. the processing of that data will then be covered by section of the federal trade commission act's language regulating unfair or deceptive trade practices. state consumer protection and privacy laws may also apply to these uses of data. many privacy commentators, including me , have described this patchwork of ftc and state enforcement as confusing and inadequate. to better foster trust in the use of telehealth, congress should pass a strong comprehensive privacy law that provides the ftc with rule making authority and substantially increased resources. iii. liability -malpractice liability remains a concern for providers of telehealth services. these concerns include a lack of a clear understanding of how the standard of care applies in telehealth, questions of whether existing malpractice insurance policies cover these services, and which state's law applies if the patient and the provider are located in different areas of the country. there are concerns that telehealth services do not allow for certain medical practices that have been considered standard for treating patients with respiratory issues, such as being increasing access to care: telehealth during covid- able to listen to the lungs with a stethoscope. it is unclear whether telehealth's inability to allow a health care professional to perform these time-tested approaches will impact their potential malpractice liability if there is an incorrect diagnosis. some states are taking action in this area. hawaii has passed a law requiring malpractice insurance carriers to provide coverage for telehealth services. other states like new york have temporarily created exemptions from malpractice liability except in situations of gross negligence. it is unclear whether concerns about when these temporary exemptions will expire will discourage health care providers from substantially investing in telehealth infrastructure due to fear of longerterm malpractice liability. liability proposals -there is continued uncertainty about the extent to which malpractice insurance carriers cover claims arising from telehealth services. states should expand their telehealth parity laws to require insurance carriers to include malpractice coverage for telehealth services on par with how they cover face to face services, and for coverage of services outside the geographic area where the doctor is licensed. also, given the possibility that telehealth may increase, or at least present new, cybersecurity risks providers also need to understand the extent to which their policies cover cybersecurity and the exemptions to coverage such as attacks by foreign nation states. congress should fund the development of education materials for doctors to check with their malpractice insurance carriers to make certain the terms of insurance policies will cover all telehealth services they are planning to provide. iv. licensure -many of the health care workers who are needed to address the current public health crisis are regulated by state professional licensure requirements that limit work across state lines. these workers include doctors, nurses, nurse practitioners, and nurses' aides. telehealth and rpm can best realize their potential to address covid- if they allow for health care workers in states that are not experiencing large infection rates to provide services to those states that are currently in crisis. this is especially true in certain practice areas where some states may have limited numbers of specialists. there is an existing system that states and the district of columbia have enacted to deal with emergency needs for health care providers. those states have enacted versions of the uniform emergency volunteer health practitioner act (uevhpa) which is model legislation increasing access to care: telehealth during covid- developed in by the uniform law commission. when enacted by a state the system allows for the emergency recognition of out-of-state health care licenses. along with emergency declarations there are also longer-term reciprocity frameworks to recognize out-of-state health care licenses. an example of this type of framework is the enhanced nurse licensure compact (enlc). the enlc provides for automatic recognition of nursing licenses from over states that participate in the agreement. many states are also amending their licensure requirements in more targeted ways. for example, alaska, missouri, and tennessee have implemented reciprocity policies. also, new jersey took action to expedite approval for out-of-state-doctors applying for licensure. connecticut is an example of a state that took more specific licensure action to enable telehealth. the state suspended the licensure/certification/registration requirements to allow telehealth services by out-of-state professionals. licensure proposals -shortages of health care workers in communities with high numbers of covid- patients is a significant concern. additional changes are necessary so that telehealth can allow doctors and nurses in other states to help even out those local shortages. states that have not passed a uevhpa law should do so quickly. also, states that are currently not participating should join the enlc. all states should amend necessary legislation to allow for the provision of telehealth services by individuals physically located outside of the state. hhs should work with state governors to put in place executive orders that allow for the creation of emergency management assistance compacts (emacs). emacs can allow for mutual recognition of doctors between states. more information on emacs, including a template executive order is available at https://www.emacweb.org/. all states should explore making permanent reciprocity for out-of-state telehealth professionals. technology access -to realize the benefits of telehealth, providers will need to deploy the technology to communities that currently lack broadband internet access and the use of smartphones. this broad use of the technology will create more diverse data that will over-time produce better telehealth implementations. the focus on increasing use of the technology will also help extend healthcare services to rural areas and undeserved urban communities. communities that are underserved with healthcare services may also be those that have limited access to reliable broadband internet service and/or the understanding of how to deploy telehealth technology. regulators have worked to broaden the list of available technologies to use with telehealth services including those that can be deployed on smartphones. in addition, hhs has funded the creation of a national network of telehealth resource centers which focus on training telemedicine providers. technology access proposals -doctors and patients are having to figure out how to use new technologies and incorporate the tools into their lives and work. outreach to doctors and patients to provide assistance on how to implement telehealth technology is necessary, including providing easy to understand education materials. to increase telehealth technology access and further the creation of diverse telehealth data for analysis, regulators should promote telehealth access across the country. hhs should increase the funding for the national network of telehealth resource centers with a specific focus on rural areas and underserved urban areas. these resource centers are important ways to help doctors and other providers understand how to offer telehealth services. the broadened set of new telehealth technologies (especially end point rpm technologies like bluetooth enabled thermometers and pulse oximeters) will create more data that can be useful to train artificial intelligence algorithms. because covid- is so new there is little data to use to train analytical algorithms and artificial intelligence solutions to determine how best to spot covid- infection, to determine which patients are at increased risk of acute illness, and to develop more effective treatment. new algorithms deployed in telemedicine require a lengthy fda pre-market assessment process. while many of the current proposals for the use of artificial intelligence in hospitalbased care, there are a number of use cases where the technology can be useful in telehealth. technology providers are pushing artificial intelligence algorithms to "the edge", meaning that they will run on the end point devices used by patients such as scales, thermometers and pulse oximeters. the fda's traditional approach to medical device review was not designed for adaptive artificial intelligence and machine learning technologies. under the fda's current approach to software modifications, the fda anticipates that many artificial intelligence software updates will need a premarket review. such a review process would substantially limit the benefits that can come from quickly updating software based on artificial intelligence learning. increasing access to care: telehealth during covid- the fda has recently proposed modifications to this assessment process that have potential to increase the speed of implementation of software changes created by machine learning and other artificial intelligence tools (ai/ml). the fda proposal is based on the following four principles: . establish clear expectations on quality systems and good machine learning practices; . this proposed regulatory approach would apply to only those ai/ml based software as a medical device that require premarket submission and not those that are exempt from requiring premarket review; . expect manufacturers to monitor the ai/ml device and incorporate a risk management approach; and . enable increased transparency to users and the fda using post-market real-world performance reporting for maintaining continued assurance of safety and effectiveness. the fda is also making changes that will allow artificial intelligence to be more useful with rpm technologies. in march of the fda provided a notification of enforcement policy to provide flexibility in the use of a number of noninvasive rpm technologies. the policy document states: "fda does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of fda cleared non-invasive remote monitoring devices that are used to support patient monitoring (hereinafter referred to as "subject devices") during the declared public health emergency, as described in more detail below, without prior submission of a premarket notification under section (k) of the fd&c act and cfr . . ." the fda policy document included examples of permissible modifications, such as "the inclusion of monitoring statements related to patients with covid- or co-existing conditions (such as hypertension or heart failure); for subject devices previously cleared only for use in hospitals or other health care facilities, a change to the indications or claims regarding use in the home setting; and hardware or software changes to allow for increased remote monitoring capability." these allowed modifications pave the way for the fda to learn more about how these technologies function in practice during the emergency, and what level of review will be necessary once the crisis subsides. ai proposals -once providers are using telehealth solutions more broadly there will be opportunities to gain value from the data those implementations create. two policy priorities can then make better use of that data. first, congress should require electronic health record vendors and healthcare providers to share data with health researchers using federated homomorphic encryption solutions. these encryption solutions can allow for important research using telehealth data while still preserving the privacy and cybersecurity of the underlying personal health information. hhs should encourage health researchers to use the increased data provided by telehealth services to train artificial intelligence software that can further improve both the telehealth services, but also other clinical care, healthcare operations, and research. also, cms should create emergency reimbursement codes for the use of narrow ai solutions such as methods to triage patients (either for the first step in a telemedicine appointment with a doctor, or as part of an automated rpm application like a daily set of questions asked by a smart phone application or through a digital assistant with voice recognition like the amazon echo or the apple homepod). to help enable this ecosystem of the use of telehealth data to improve artificial intelligence healthcare algorithms the fda should move quickly forward with their proposed new artificial intelligence assessment process. concurrently the fda should create a streamlined assessment pathway for critical ai uses in addressing covid- , such as allowing rapid retraining of known cleared ai applications towards other uses and further expansion of them for those new uses. an example of this type of expansion for a new purpose could be the use of algorithms that have been used in radiology to assist a doctor in spotting lung cancer to now also detect covid- respiratory infection. data from telehealth could provide substantial assistance in augmenting existing training data with an understanding of how patients progress over time. the fda, hhs and state regulators have done tremendous work in a short period of time to remove regulatory barriers and create incentives to enable the use of telehealth, and specifically rpm services, during the covid- public health emergency. there are still actions that need to be taken in the areas of reimbursement, privacy/cybersecurity, liability, licensure, technology access, and ai. as we move past the crisis, regulators should examine how companies are using personal health information that is transmitted using telehealth technologies, and whether additional restrictions on the use of the data are necessary. further, this emergency will likely introduce millions of americans to using telehealth services, providing substantial benefits to patients including, but not limited to, those who live in rural areas with limited access to healthcare. regulators should make use of the data on the use of these services during this emergency. collecting data and allowing for its analysis by researchers can assist congress, hhs and state regulators to determine which of the regulatory changes to make permanent. this data analysis can also help determine what further changes are necessary to properly incentivize providers to fully utilize these services, technology companies to continue to innovate in this area, and for insurers to adequately reimburse and cover malpractice claims. state telehealth law & reimbursement policies: a comprehensive scan of the states & the district of columbia key: cord- -mpm aga authors: teixeira, andre luiz schuh; spadini, alex vicente; pereira-sanchez, victor; ojeahere, margaret isioma; morimoto, kana; chang, alice; de filippis, renato; soler-vidal, joan title: la urgencia de implementar y ampliar la telepsiquiatría durante la crisis de covid- : perspectiva de los psiquiatras que inician su carrera date: - - journal: rev psiquiatr salud ment doi: . /j.rpsm. . . sha: doc_id: cord_uid: mpm aga nan if few months ago, psychiatrists were told that their practice would be transformed and mental health care would be compelled to reinvent due to a respiratory syndrome, few would have believed it. however, an unforeseen severe global health crisis is leading to significant changes in the field of psychiatry. currently, there are millions of cases and hundreds of thousands of deaths confirmed worldwide with coronavirus disease (covid- ), an illness classified by the world health organization as a global pandemic. because effective treatments or vaccines for the sars-cov- are still nonexistent, social distancing and isolation remain the most successful strategies to prevent countries from humanitarian disasters and collapse of their national health systems. however, diseases other than covid- still exist, and their burden may be worsened by the emergency situation and the effects of quarantine. despite the disruptions in the normal functioning of psychiatric services, which have limited the ability to provide regular care, especially in outpatient settings, patients with new and existing mental health conditions should be followed up remotely. this is more compelling for patients with previous severe mental disorders or new-onset severe emotional distress, in which the consequences of destabilization or suicidality could be fatal. in these cases, telepsychiatry is called to be a game changer. telemedicine is defined by the american psychiatric association as "the process of providing health care from a distance through technology, often using videoconferencing". telepsychiatry, a subgroup of telemedicine, involves providing psychiatric care through a range of services including psychiatric evaluations, therapy, patient education and medication management. early career psychiatrists (ecps) from several regions of the world are optimistic that this pandemic will provide the opportunity to implement and expand telepsychiatry to urgently address the current mental health care needs of the population in times of physical distancing. indeed, telepsychiatry has already become a powerful tool in the mental health with demonstrated effectiveness in us and australia for disorders like depression , anxiety , psychosis and ptsd . therefore, it may be used even for patients suffering from covid- , people impacted by confinement, and frontline health workers. historically, times of crisis have provided opportunities for major developments and breakthroughs. the current one has the potential to show that technology can facilitate access to mental health care. telemedicine has been demonstrated to have good acceptability among patients and clinicians, as well as an effectiveness comparable to face-to-face interventions. nevertheless, traditional psychiatric services have been slow to take up digital forms of care delivery. many barriers have to be considered, from affordability to ethical concerns such as confidentiality and safety. from the service users side, even the senior citizens technological gap could be a limitation to telepsychiatry spread, especially concerning configuration and usability of digital devices. moreover, in order to implement telepsychiatry, it is necessary to provide training and protocols. nevertheless, the present circumstances show the necessity to tackle them, for example with secure channels, electronic prescription systems to avoid patients to go to the clinic to have their prescription updated, and developing guidelines adapted from those countries which have been using telemedicine for years and modifying them to different cultural, technical, legal and practice contexts for clinical best practice. availability of telepsychiatry may vary from place to place. in countries where it is well established and online platforms exist, a patient can schedule a video conferencing with their provider. in low-and middle-income countries telepsychiatry is still incipient despite its demonstrated cost-effectiveness. , it is also necessary to institute new legal regulations to encourage the use of technology while ensuring best practices. our patients can no longer wait. in these difficult times, we cannot stop providing psychiatric care, and telepsychiatry is the tool that psychiatrists should adopt to overcome the obstacles that the coronavirus outbreak has imposed and to help patients in isolation. we can provide hybrid forms of care, while recognizing the importance of traditional face-to-face care. right now, we have the necessary technology to improve access to healthcare with low cost and high efficiency. our adoption of telepsychiatry now will be the basis of future developments after the pandemic. furthermore, technology might even improve doctor-patient relationships by enhancing more communication opportunities. ecps must lead the change to increase the use of telemedicine in psychiatry. our mission to alleviate mental suffering should not be overshadowed by personal hesitation or resistance to the new. we invite ecps from all over the world to participate in what can be a mental health revolution for the benefit of patients. we need telepsychiatry, and we need it now. covid- and rationally layered social distancing patients with mental health disorders in the covid- epidemic what is telepsychiatry? s. f usability, and effectiveness: a qualitative study evaluating a pediatric telemedicine program psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial. the lancet psychiatry e-health interventions for anxiety and depression in children and adolescents with long-term physical conditions use of mobile technologies in patients with psychosis: a systematic review telemedicine-based collaborative care for posttraumatic stress disorder: a randomized clinical trial effectiveness of a multimodal digital psychotherapy platform for adult depression: a naturalistic feasibility study key: cord- - v bc z authors: matterne, uwe; egger, nina; tempes, jana; tischer, christina; lander, jonas; dierks, marie-luise; bitzer, eva-maria; apfelbacher, christian title: health literacy in the general population in the context of epidemic or pandemic coronavirus outbreak situations: rapid scoping review date: - - journal: patient educ couns doi: . /j.pec. . . sha: doc_id: cord_uid: v bc z objective: the aim of this rapid scoping review, for which only studies from the general population were considered, was to describe the extent of existing research on hl in the context of previous coronavirus outbreaks (sars-cov- , mers-cov and sars-cov- ). methods: we searched major databases and included publications of quantitative and qualitative studies in english and german on any type of research on the functional, critical and communicative domains of hl conducted in the context of the three outbreaks in the general population. we extracted and tabulated relevant data and narratively reported where and when the study was conducted, the design and method used, and how hl was measured. results: studies were included. three investigated hl or explicitly referred to the concept of hl, were guided by health behaviour theory. we did not find any study designed to develop or psychometrically evaluate pandemic/epidemic hl instruments, or relate pandemic/epidemic or general hl to a pandemic/epidemic outcome, or any controlled intervention study. type of assessment of the domains of hl varied widely. conclusion: theory-driven observational studies and interventions, examining whether pandemic-related hl can be improved are needed. practice implications: the development and validation of instruments that measure pandemic-related hl is desirable. in late an outbreak of a new viral disease occurred in wuhan, china and later spread to almost all countries of the world [ ] . it is caused by a novel beta coronavirus, the severe acute respiratory syndrome -coronavirus - (sars-cov- ), which causes coronavirus disease (covid) - ) [ ] . the clinical epidemiology of covid- is currently being investigated intensely [ ] . course of disease may be very mild, asymptomatic to very severe with respiratory and systemic damage and requiring mechanical ventilation [ ] . responses of governments to the covid- pandemic have been multifaceted including outbreak management (suppression versus mitigation), provision of adequate clinical treatment facilities for severe cases and measures to alleviate the economic and psychosocial impact of the pandemic and the measures taken to manage it [ ] . public health measures implemented in many countries across the globe encompass contact restrictions and physical distancing, hygiene rules (i.e. frequent and thorough handwashing or disinfection), mask wearing, eye protection and recommendations about how to sneeze and cough [ , ] . some of these measures, particularly contact restrictions, have been law enforced in many countries [ ] . relaxing regulations and re-organising social life requires people to voluntarily adhere to the named measures in order to avoid exponential growth of sars-cov- to reoccur. further, people who contract sars-cov- need to know when and how to seek health care and/or be tested. those who suffer from severe covid- and survive will have to seek health care to mitigate the potentially long-lasting physical and psychological sequelae such as kidney damage [ ] or post-traumatic stress disorder [ ] . in all these and other different scenarios, the concept of health literacy (hl) becomes a vital public health concept that is essential to counterpart on the individual level the social restrictions enforced by law. when restrictions are gradually lifted, the role of individual level hl increases in order to prevent the resumption of these restriction, should infection numbers surge again. the currently prevailing integrated hl notion "entails the motivation, knowledge and competencies to access, understand, appraise and apply health information in order to make judgements and take decisions in everyday life concerning healthcare, disease prevention and health promotion to maintain or improve quality of life throughout the course of life" [ ] and is promoted by who (world health organisation) europe [ ] . while other notions refer, for instance to hl being the result of health education and distinguishes the distinct concepts of functional, critical and communicative hl [ ] the aforementioned hl notion was arrived at by a systematic review and an integration of medical and public health views of hl [ ] . in other words, what is necessary beyond governmental regulations and policy, is an increase in the levels of covid- related health literacy [ , ] . we not only need to monitor the pandemic's epidemiology during the course of the pandemic including the creation of herd immunity but also hl and health behavioural responses related to the pandemic in the population [ ] . hl is considered a major determinant of a person's health [ , ] , a factor that contributes to health inequalities [ ] , and a person's health behaviour, for instance, healthy diet adherence or non-smoking [ ] and health care j o u r n a l p r e -p r o o f utilisation [ ] . there is evidence that lower hl is consistently associated with mortality [ ] or lower self-rated health status [ ] . research suggests that adequate hl may not be as prevalent among populations as might be necessary in order to navigate the increasingly complex healthcare landscape [ , , ] . synthesised evidence suggests a relationship between levels of hl and infectious disease prevention in non-pandemic contexts [ ] . inadequate hl was found to be associated with reduced adoption of protective behaviours such as vaccination uptake and poor understanding of antibiotics [ ] . large research gaps were found in relation to infectious diseases with a high clinical and societal impact, such as tuberculosis and malaria [ ] . for instance, it was emphasised that critical hl, which focuses on supporting effective political and social action, was not considered in any of the reviewed studies [ ] . the strengths of this relationship may be exponentially higher under pandemic circumstances, but no synthesised information on this topic appears to exist to date. further, the importance of individual hl in pandemic control has been emphasised more urgently [ , ] . therefore, the aim of this rapid scoping review, for which only studies from the general population were considered, was to describe the extent of existing research on hl in the context of previous coronavirus outbreaks (sars-cov- , mers-cov and sars-cov- ). the world health organisation (who) declared only sars-cov- a pandemic [ ] while mers-cov [ ] and sars-cov- [ ] remained epidemics. facets of hl that were of particular interest were: type of assessment of hl (theory-based versus proxy assessment; validated instrument versus ad hoc assessment), interventions aiming to improve hl during outbreak situations, or hl surveillance during outbreak. this scoping review was performed according to the methodological framework as outlined by khalil et al. [ ] . their guidelines regarding scoping reviews build on the work of arksey and o'malley's fivestage scoping review framework [ ] , complemented with the joanna briggs institute methodology [ ] , in order to ( ) identify the research questions, ( ) identify relevant studies, ( ) select studies, ( ) chart the data, and ( ) collate and summarise the data. a scoping review's objective is to identify the nature and extent of the existing evidence. unlike other types of review, it does not endeavour to systematically evaluate the quality of available research, but rather seeks to identify the contribution of existing literature to an area of interest [ ] . our methodology was also guided by the rapid review approach which inevitably uses less rigor as is required by a traditional systematic review due to the need for production within a short time-frame using limited resources [ ] . the protocol for this rapid review was registered at osfregistries on / / [ ] . two authors (um, ne) ran the search strategy on pubmed (medline®) and psycinfo® on th april . citations were downloaded to citavi (swiss academic software). we included publications in english and german of quantitative and qualitative studies. the same authors evaluated titles and abstracts excluding any irrelevant ones. full texts of the remaining citations were obtained, and two authors (um, ne) reviewed these, excluding any, which did not meet the inclusion criteria. finally, reference lists of remaining papers were hand-searched for additional relevant studies. we then compared results from full text screening; there were only minor discrepancies, which were resolved through discussion with the whole team. data extraction was carried out by five authors (um, ne, jt, ct, jl) in independent pairs of two. consensus was achieved through discussion and arbitration within the team. the search strategy was informed by hl theory (derivation of search terms) and is displayed in appendix . inclusion criteria were: we included reports on any type of research on the functional, critical and communicative domains of hl [ ] conducted in the context of sars-cov- , sars-cov- and mers-cov in the general population. this was a rational decision as an initial search using hl as the chief search term in conjunction with the aforementioned coronavirus outbreaks resulted in very few hits. we used the following definitions / concepts of functional, communicative and critical hl: functional hl is broadly compatible with the narrow definition of 'health literacy' which can be considered to consist of healthrelated knowledge, risk perceptions, attitudes, motivation, behavioural intentions, personal skills, or self-efficacy [ ] . communicative hl means to be able …'to derive meaning from different forms of communication'…, while the ability to critically analyse information is referred to as critical hl [ ] . the following data were extracted from the included studies: authors, publication year, country of study, type of epidemic or pandemic outbreak (sars-cov- , sars-cov- , mers-cov), participants (including sample size), design, method, and instruments, and measured constructs including how they were measured (only if applicable e.g. not in qualitative studies). findings were synthesized quantitatively and narratively and reporting followed the guidelines as proposed in prisma-scr [ ] . a critical appraisal of the quality of the included studies was not within the scope of this review. we do however, comment on major methodological issues regarding the studies. there was no funding source for this study. the search in pubmed (medline®) and psycinfo® yielded references, two were obtained from colleagues [ , ] , leading to references after removal of duplicates. title and abstract screening all studies, while mainly not explicitly investigating hl, measured one or more components of hl (appendix ). most studies were observational or short longitudinal ( cross-sectional, eight pre-post) and six qualitative. all sars-cov- studies were conducted during, of the mers-cov studies during, one during (first wave), eight after, of the mers-cov studies during, one after and one both during and after the pandemic/epidemic outbreak. studies used questionnaires, two used focus group discussions, four others used qualitative methods (e.g. interviews) for data collection. studies investigated convenience or opportunity samples and representative samples drawn from general populations. sample size ranged from - . participants. within the nine quantitative sars-cov- studies, knowledge was measured in seven, attitude in seven, risk perceptions in four, self-efficacy in three, critical hl in five, communicative hl in three, healthinformation seeking behaviour (hisb) in two, and behavioural aspects in four studies. only one study [ ] table ) . wearing a mask was the most frequently assessed behaviour ( table ) . quantitative studies were conducted in the context of sars-cov- . measured knowledge, attitude, risk perception, eight se, critical hl, communicative hl, and behaviour. one study [ ] reported all six hl aspects, the others one to five aspects. within knowledge, transmission mode was most often measured. although studies reported knowledge assessment, most studies did not comprehensively assess knowledge ( table ) . handwashing was the most frequently measured behaviour ( table ) . of the quantitative mers-cov studies measured knowledge, attitude, risk perceptions, se, critical hl, communicative hl, and behaviour. two studies assessed five of the six hl aspects [ , ] , the remainder one to four. within knowledge, transmission mode was most often assessed. again, most studies did not comprehensively assess knowledge. handwashing was the most frequently assessed behaviour ( table ) . the reported measured depth within the domains of hl varied widely among the studies (results not shown). for instance, the number of knowledge components ranged from one to at least eight. hisb was measured in two (sars-cov- ), four (sars-cov- ), two (mers-cov) quantitative studies. our search failed to come across any studies designed to develop or psychometrically evaluate pandemic/epidemic hl instruments or relate pandemic/epidemic or general hl to a pandemic/epidemic outcome. the number of items per hl aspect varied widely (data not shown), hardly any study reported on psychometric properties, two studies from three publications [ , , ] were the notable exception (appendix ) and a clear distinction between knowledge, attitude, or risk perceptions was sometimes absent. for instance, perceived vulnerability was reported as an attitude [ ] . six qualitative studies explored domains of hl in the context of sars-cov- , sars-cov- , and mers-cov. one focus group study [ ] reported low risk perceptions and a lack of seeking relevant health information in relation to sars-cov- . one interview study [ ] and one focus group study [ ] explored risk perceptions and preventive behaviour in relation to sars-cov- , another interview study [ ] explored individual experiences during quarantine. one interview study reported low knowledge about sars-cov- and its prevention [ ] . another interview study in the context of sars-cov- concluded that attitudes towards mask wearing had substantially changed in the post-sars-cov- period [ ] . while individual hl is recognised as an increasingly important construct in public health [ ] , it is of note that only three studies emerged from our extensive search, which explicitly referred to the construct of hl in the context of any of the three coronavirus outbreaks. one used the newest vital sign (nvs), a test measuring nutrition label information processing ability [ ] , another study [ ] administered a short form of the hls-eu-q , an hl instrument rooted in testable theory [ ] and the third [ ] study used a version of the hls-eu-q adapted to sars-cov- . however, the latter provided no evidence on the psychometric properties of the adapted instrument. hence, at present there seems to be no tested instrument designed to measure coronavirus pandemic-related hl. there is, however, one hl instrument assessing print and multimedia literacy in respect to respiratory diseases [ ] . most of the other included studies were not theory-based. it is important to highlight that these studies did not purport to measure hl, but were included in this review because the search strategy was based on a pragmatic application of suggested hl components within domains [ , ] . of those that were theory-driven, the majority employed health-behaviour theory as conceptualised by social cognition models. there is substantial overlap between socio-cognitive predictors of health behaviour and hl. for instance, attitude and self-efficacy (defined as behavioural control) are part of the theory of planned behaviour [ ] , risk perceptions part of the health belief model [ ] or knowledge part of protection motivation theory [ ] . theory-based research allows the formulation of testable a priori hypotheses, and if necessary revision of the theory. nonetheless, the measures obtained from those studies lacking an explicit theoretical foundation can be considered proxies of hl because they constitute or at least contribute to one or more hl domains. while there appears to be no evidence linking validly measured (epidemic or pandemic) hl to coronavirus outbreak/pandemic outcomes there is evidence that hl can be linked to other epidemic outbreaks, e.g. the - ebola epidemic outbreak in west africa resulted among other factors from low health literacy [ ] . a center for disease control and prevention campaign, with input from partners, helped increase hl [ ] . hl has also been shown to be associated with health and health behaviour in general. hence, one would expect that this association would hold in coronavirus outbreak situations. communicative hl included the measurement of access to different sources of information. whether this had anything to do with better decisions about health in relation to any of the three outbreaks, remained unclear. knowledge items were generally devised by the authors, and very few reported to have items checked against guidelines. this and the lack of an objective standard for cut-offs make knowledge assessment arbitrary as it cannot be established whether knowledge items reflect current and correct evidenced knowledge. similarly, while risk perceptions generally pertain to perceptions of vulnerability/susceptibility to and severity of a disease, they were not always measured accordingly or sometimes subsumed under the term attitudes or knowledge. we also observed very little evidence about the psychometric properties of instruments used to measure socio-cognitive variables such as attitude, risk perceptions, and self-efficacy. it is desirable to know whether measures are reliable and valid, and sensitive to change if the aim is to reflect the effects of health literacy interventions by e.g. education (responsiveness). even if knowledge, attitudinal constructs, risk perceptions or self-efficacy were composed in a clear-cut and unequivocal way and psychometrically sound, uncertainty as to whether hl in its broader definition [ , ] as a composite/compound construct was measured, would still prevail. hl was proposed to be a latent construct [ ] thus indicators for its measurement are necessary. there is the need for the development of adequate measurement models. the present review cannot ascertain, whether established instruments such as tofhla (test of functional health literacy) [ ] , or the broader dimension based instruments, for instance the hlq (health literacy questionnaire) [ ] could be used to predict a pattern of association between hl and epidemic or pandemic outcomes (and antecedents such as favourable behaviours and practices), because no such investigations appear to have been carried out, yet. the study [ ] that used a short form of the j o u r n a l p r e -p r o o f hls-eu-q did not investigate the relationship between hl and pandemic outcome/preventive behaviour but coping responses to the outbreak (depression, quality of life). okan et al. [ ] reported individuals' subjective perceptions about how well they could access, understand, appraise and apply information in the sars-cov- context but did not test the actual level of what these skills pertain to and whether they are related to better/more favourable behaviour/practices. further, it also not possible to state at present whether pandemic outbreaks require a specific hl instrument, that is able to explain variance in relevant behaviour and practices over and above that of general instruments (i.e. latent trait/construct measured by discrete manifest cognitive antecedents of behaviour). in this rapid review, the systematic search was restricted to two major data bases and no grey literature search was conducted. also, as this review was conducted as a scoping review, we did not look at the strengths of any reported associations between hl aspects and behavioural aspects. further, it is beyond the scope of this review to assess the quality of the reviewed studies according to standard guidelines for observational studies. at present hl in the context of coronavirus outbreaks is at an early stage to inform public health/educational strategies aimed at improving the public's hl in order to contain the spread of pandemics. one study [ ] appears to be able to shed light on the question of whether hl related aspects change over the course of the pandemic as its survey is conducted in weekly intervals. we recommend future research be guided by theory from hl research [ , ] in the much needed work on hl in pandemic outbreak situations. consequently, assessment of hl should be based on the ability to access, understand, critically appraise and eventually apply information to make better choices about one's health in pandemic outbreak situations when viewed as a set of meta-cognitive skills or a latent trait [ ] . nevertheless, operationalisations at the manifest level, for example, knowledge, or attitudes (which influence critical appraisal) need to be 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facemask in hong kong since the severe acute respiratory syndrome (sars) outbreak: implications for infection control in the post-sars era health literacy: a prescription to end confusion measuring health literacy in populations: illuminating the design and development process of the european health literacy survey questionnaire (hls-eu-q) measuring health literacy regarding infectious respiratory diseases: a new skills-based instrument advancing health literacy: a global challenge for the st century the theory of planned behaviour: reactions and reflections the health belief model: explaining health behavior through expectancies handbook of health behavior research : personal and social determinants caring for critically ill patients with ebola virus disease lessons of risk communication and health promotion -west africa and united states a tale of two health literacies: public health and clinical approaches to health literacy the test of functional health literacy in adults: a new 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infection sensitivity during the korea outbreak of middle east respiratory syndrome in tuning in and catching on? examining the relationship between pandemic communication and awareness and knowledge of mers in the usa effectiveness of an education health programme about middle east respiratory syndrome coronavirus tested during travel consultations public awareness of coronavirus in al-jouf region knowledge, attitudes and practices concerning middle east respiratory syndrome among umrah and hajj pilgrims in samsun australian hajj pilgrims' knowledge about mers-cov and other respiratory infections middle east respiratory syndrome risk perception among students at a university in south korea associations between hand hygiene education and self-reported hand-washing behaviors among korean adults during mers-cov outbreak the effects of sns communication: how expressing and receiving information predict mers-preventive behavioral intentions in south korea germany covid- snapshot monitoring (cosmo germany): monitoring knowledge, risk perceptions, preventive behaviours, and public trust in the current coronavirus outbreak in germany gesundheitskompetenz der bevölkerung im umgang mit der coronavirus-pandemie to what extent are arab pilgrims to makkah aware of the middle east respiratory syndrome coronavirus and the precautions against it? identification of information types and sources by the public for promoting awareness of middle east respiratory syndrome coronavirus in saudi arabia  yes;  no; n.a.: not applicable; hisb: health information seeking behaviour; n.r.: not reported; * includes related concepts (e.g. outcome expectancies, response efficacy); † perceived vulnerability and/or severity; ‡ skills (self-efficacy, skills, preparedness)j o u r n a l p r e -p r o o f [ , ] [ , [ ] [ ] [ ] [ ] , , , , ] [ , , , , , , , , ] transmission mode [ , , , , ] [ ] [ ] [ ] , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , ] symptoms [ , , [ ] [ ] [ ] [ ] [ ] [ , , , , , , , ] [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , , , ] [ ] [ ] [ ] hb: health behaviour; hisb: health-information seeking behaviour; note: cited references do not correspond to number of studies but publications j o u r n a l p r e -p r o o f key: cord- - adnvav authors: lowenthal, john title: overview of the csiro australian animal health laboratory date: - - journal: j infect public health doi: . /j.jiph. . . sha: doc_id: cord_uid: adnvav emerging infectious diseases arising from livestock and wildlife pose serious threats to global human health, as shown by a series of continuous outbreaks involving highly pathogenic influenza, sars, ebola and mers. the risk of pandemics and bioterrorism threats is ever present and growing, but our ability to combat them is limited by the lack of available vaccines, therapeutics and rapid diagnostics. the use of high bio-containment facilities, such as the csiro australian animal health laboratory, plays a key role studying these dangerous pathogens and facilitates the development of countermeasures. to combat diseases like mers, we must take a holistic approach that involves the development of early biomarkers of infection, a suite of treatment options (vaccines, anti-viral drugs and antibody therapeutics) and appropriate animal models to test the safety and efficacy of candidate treatments. over the past three decades, there has been an increase in the incidence of emerging infectious diseases (eids) in humans, with approximately percent of them arising from animals. a number of factors, including the geographic expansion of human populations, intensification of agriculture and habitat disruption due to climate change and deforestation, have led to a greater risk of eids being transmitted from wild and domesticated animals to humans [ ] . furthermore, increased global travel and trade has increased the likelihood that eids will rapidly spread. eid outbreaks are unpredictable and often difficult to contain due to the absence of effective control measures such as vaccines and antiviral therapeutics. the world health organization has warned that the next human pandemic is likely to be zoonotic and that wildlife is a prime culprit. while the current list of known eids is a major concern, it is the existing unknown threats with the potential for efficient human-to-human transmission that pose the largest concern. over the past decade, there have been a number of epidemics, raising the concern that they are precursors to a pandemic. examples include the highly pathogenic h n avian influenza virus that has decimated poultry production in asia and claimed over lives since with continuing regular outbreaks, the hendra virus in australia, the nipah virus in malaysia and bangladesh and hemorrhagic fever viruses (ebola and marburg), which have emerged from bats via intermediate hosts, such as horses and pigs, to infect and kill humans over the past two decades. the sars epidemic in - claimed over lives and cost more than $ b to the global economy. the virus was shown to be transmitted from bats to civet cats to humans. in , a novel coronavirus emerged in the middle east (mers-cov), with a % mortality rate for the more than currently confirmed cases in counties. bsl and facilities must conform to strict infrastructure requirements, policies and procedures to ensure the safety of researchers who are working with a range of dangerous pathogens. there are several international bodies that develop and maintain biosafety guidelines. in the united states, it is the centers for disease control and prevention (cdc) in partnership with the u.s. national institutes of health biosafety (http://www.cdc.gov/biosafety/ publications/bmbl /bmbl.pdf). the european guidelines are set by a legislative act of the european union. in australia, the department of agriculture and the office of the gene technology regulator have this responsibility. while regulations surrounding bsl and facilities may differ from country to country, the basic principles of biocontainment are uniformly observed. for example, all work involving potentially infectious material must be conducted within primary containment, such as a biological safety cabinet. in the case of bsl facilities, primary containment is provided by a class iii biological safety cabinet located within a bsl cabinet laboratory or by the wearing of positive pressure protective suits with an independent breathing air supply (bsl suit laboratory or animal facility). examples of bsl- laboratories around the world include the national microbiology laboratory (winnipeg, canada, http://www. nml-lnm.gc.ca/index-eng.htm), the pirbright institute (pirbright, uk, http://www.pirbright.ac.uk/), the uniformed services university of the health sciences (bethesda, usa, http://www.usuhs. mil/) and the csiro australian animal health laboratory (geelong, australia, http://www.csiro.au/ places/aahl). the aahl is one of the world's premier highbiocontainment facilities, allowing researchers to work with bsl pathogens that are highly lethal to humans and for which there is no vaccine or effective treatment. the aahl is unique in the world in its capacity to undertake studies on a wide range of large numbers of domestic animals and wildlife [ ] . at the aahl, exotic disease agents are used in the laboratory for researching emergency disease diagnoses and studying the relationships between the pathogens and different animal and human hosts. the aahl facility is unique in that its bsl and bsl animal facilities are sufficiently large to allow researchers to study a range of security sensitive biological agents (ssbas) in diverse species, including ferrets, bats, poultry, pigs, dogs, alpacas and horses, as well as small laboratory mammals. as one of only six high-containment animal research centers in the world, we work with national and international human and animal health organizations as part of a global one health network. aahl's mission is to be prepared to quickly and effectively respond to any new emerging infectious disease that may emerge. it does so by working with government and industry to assist in responding quickly to stop threats in their tracks and provide sustainable management strategies. we are exploring new technologies for detection, surveillance, diagnosis and response, and we will continue preparing for the next human pandemic. the csiro emerging infectious diseases program located at aahl has assembled a strong set of multidisciplinary research teams spanning the areas of virology, immunology, veterinary sciences and animal models. by understanding disease emergence and the host response to pathogens, we will inform public policy and develop innovative technologies to enable our industry partners to manufacture and deploy novel disease treatments to protect us from infectious diseases that threaten our wellbeing, economy and environment. the use of mouse models has been fundamental to our understanding of human infection and disease, and mice have become the traditional 'workhorse' because of their ease of handling, their fast generation time and the ready availability of mousespecific reagents. however, for many zoonotic pathogens, there are differences in the symptoms of the disease between the natural reservoir animal host (such as a bat or bird) and human hosts. frequently, zoonotic infections appear asymptomatic and are non-lethal in the natural host, yet induce severe and potentially lethal disease in humans or other spillover hosts. nevertheless, there are numerous factors that are likely to contribute to these differences, including anatomical, physiological, metabolic and behavioral traits, as well as how the immune systems of these hosts interact with the same disease agent. therefore, for a better understanding of eids, the laboratory mouse may not be the most appropriate model. there are many examples in the literature where non-traditional animal models have been highly informative for our understanding of the host responses to pathogens [ ] . for example, we are using bats to study several emerging viruses such as hendra virus, and ferrets, which are widely accepted as an excellent model for influenza infection; they are naturally susceptible to infection with human influenza viruses and the disease pathology they develop resembles that of humans infected with influenza. furthermore, by studying the pathogen in its natural host, we may be able to devise efficient control measures in that host, thereby disrupting their transmission to humans. this has important implications for predicting, preventing and controlling spillover events and for the development of novel therapeutics and diagnostics. it is very difficult and often impossible to test the efficacy of new treatments for highly lethal infections in human clinical trials. animal models for human eids can play a key role in the development and testing of candidate vaccines and therapeutics and can be used to facilitate their regulatory approval. the us food and drug administration (fda) has developed the animal rule to assist in the regulatory approval process [ ] . the rule states that when it would not be ethical to perform human challenge studies to measure the efficacy of vaccines and drugs developed to prevent or treat highly pathogens, the fda may grant approval based on appropriate animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce a clinical benefit in humans. the animal rule states that the fda will only rely on evidence from animal studies to provide substantial evidence of effectiveness when strict criteria are met. at the aahl, we have pioneered the concept of reducing the risk of human infection by breaking the transmission chain of a zoonotic agent from an animal host to the human. hendra virus circulates in its natural reservoir host, the fruit bat, without producing clinical disease. on occasions, the virus spills over to horses and causes a rapidly lethal respiratory disease, which can be easily spread to humans by direct contact. hendra virus causes % mortality in humans, but only a small number of cases have occurred, making the development of a human vaccine economically non-viable. instead, we developed a vaccine for horses (equivac hev, zoetis australia) that protects them from hendra virus infection and therefore indirectly prevents the infection of humans [ ] . we suggest that a similar approach of vaccinating camels against mers will help prevent mers infection of humans. however, the timeline and obstacles required to develop such a vaccine cannot be underestimated [ ] . no funding sources. global trends in emerging infectious diseases a road less travelled: large animal models in immunological research hendra virus vaccine, a one health approach to protecting horse, human, and environmental health middle east respiratory syndrome: obstacles and prospects for vaccine development none declared. not required.available online at www.sciencedirect.com key: cord- - euup authors: paniagua-avila, alejandra; fort, meredith p.; glasgow, russell e.; gulayin, pablo; hernández-galdamez, diego; mansilla, kristyne; palacios, eduardo; peralta, ana lucia; roche, dina; rubinstein, adolfo; he, jiang; ramirez-zea, manuel; irazola, vilma title: evaluating a multicomponent program to improve hypertension control in guatemala: study protocol for an effectiveness-implementation cluster randomized trial date: - - journal: trials doi: . /s - - - sha: doc_id: cord_uid: euup background: hypertension is a major risk factor for cardiovascular disease (cvd). despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (lmics). we will evaluate an adapted version of a multilevel and multicomponent hypertension control program in guatemala, previously proven effective and feasible in argentina. the program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback. methods: using a hybrid type effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in guatemala over an -month period. through a cluster randomized trial, we will randomly assign health districts to the intervention arm and to enhanced usual care across five departments, enrolling participants per health district and participants in total. the clinical outcomes are ( ) the difference in the proportion of patients with controlled hypertension (< / mmhg) between the intervention and control groups at months and ( ) the net change in systolic and diastolic blood pressure from baseline to months. the context-enhanced reach, efficacy, adoption, implementation, maintenance (re-aim)/practical robust implementation and sustainability model (prism) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness. discussion: we will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. this study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in guatemala and other lmics. trial registration: clinicaltrials.gov: nct . registered on april . hypertension is the leading preventable risk factor for cardiovascular disease (cvd), premature death and disability worldwide [ ] . it contributes to the burden of cardiovascular disease and chronic kidney disease worldwide, particularly in low-income and middleincome countries (lmics) [ , ] . it is estimated that . % of the adult population had hypertension in , three quarters of whom were living in lmics [ ] . while its prevalence is steady or decreasing in high-income countries, it increased by . % from to in lmics [ , ] . in latin america, hypertension is the most important risk factor for coronary heart disease and stroke [ ] . however, the proportion of patients who are aware, treated and controlled is low. a survey conducted in guatemala showed that the prevalence of hypertension in adults older than years is %, while only % are aware of their condition and only half of those who are aware usually take antihypertensive medications [ ] . despite the availability of evidence-based hypertension treatment guidelines, multiple barriers hinder the appropriate management of hypertension in primary care settings. hypertension guidelines recommend antihypertensive medications and individualized lifestyle changes, which include weight loss, physical activity, reduced alcohol and sodium intake, and a diet rich in fruits and vegetables and in low-fat dairy products with reduced saturated and total fat (dietary approaches to stop hypertension, dash) [ ] [ ] [ ] [ ] [ ] [ ] . our formative needs assessment documented several limitations related to hypertension management in guatemala, including a limited health budget for the treatment of non-communicable diseases, fragmented governance and service delivery, inadequate training of the healthcare workforce, and shortage of essential hypertensive medications and basic equipment, particularly at frontline facilities [ ] . in addition, an overarching challenge is the prioritization of infectious diseases and maternal and child health over non-communicable diseases [ ] . in other countries, barriers for implementing hypertension treatment guidelines at the primary care level include organizational-level obstacles, communication problems between the primary and secondary levels of care, multiple competing demands on physicians' time, and lack of reimbursement for preventive counseling [ , ] . many implementation strategies targeting healthcare administration, facilities, providers, and patients have been proven effective at improving hypertension control. specifically, these strategies include team-based care, health coaching sessions, home-based blood pressure (bp) monitoring, clinical decision support, bp audit and feedback, and training of healthcare providers. moreover, a combination of strategies is more effective than individual ones [ ] . this study is an implementation-effectiveness, hybrid, type , cluster randomized control trial that will evaluate a multilevel and multicomponent hypertension control program within the guatemalan primary care system [ ] . through a formative mixed-methods assessment and adaptation workshops, we have adapted the effective hypertensive control program in argentina (hcpia) and other implementation strategies to the guatemalan context [ ] . the multicomponent program includes a protocol-based hypertension treatment and five implementation strategies: team-based collaborative care, health provider education, health coaching sessions, home blood pressure monitoring, and blood pressure audit and feedback. this program targets the first level (health posts) and second level (health centers) of care in the public health system. the guatemalan public health system serves % of the population and is organized in three levels of care [ ] . the first, second, and third levels comprise health posts, health centers, and hospitals, which serve the community, municipal, and the regional level, respectively. health posts are staffed by auxiliary nurses, while health centers are staffed by general physicians, professional nurses, auxiliary nurses and, in some cases, psychologists or social workers. health posts and health centers are responsible for providing promotional, preventative, and primary care services. health districts represent the municipal administration. the three levels of care are connected by referral networks with the goal of decentralizing health services and increasing access to care. however, the vast majority of healthcare providers and facilities are concentrated in urban areas, leaving rural communities with limited access to health services [ ] . we are conducting this study within the first (health posts) and second (health centers) levels of care. with approval from the ministry of health, we selected health districts distributed in five departments: baja verapaz (n = ), chiquimula (n = ), huehuetenango (n = ), sololá (n = ), and zacapa (n = ). the study will be implemented at the health center and - health posts per health district, making a total of health centers and health posts (see fig. ). the eligibility criteria for health districts are the following: . having at least one health post with two or more auxiliary nurses and basic infrastructure to store clinical charts . serving rural and semirural communities . having at least one professional nurse or physician per health district, responsible for supervising the health post(s) the overarching aim of this study is to evaluate the clinical effectiveness and implementation outcomes of a hypertension control multicomponent program within the first and second levels of care in guatemala, compared to usual care. our main hypothesis is that the multicomponent program will improve hypertension control among patients with uncontrolled hypertension treated in the public healthcare system of guatemala. the co-primary objectives are: . to test if a multilevel and multicomponent intervention program improves hypertension control among guatemalan hypertensive patients over an -month period compared to usual care. . to evaluate the acceptability, adoption, feasibility, fidelity, adaptation, reach, and sustainability of implementing the intervention in the primary care setting. the secondary objective is . to evaluate the cost-effectiveness of the multilevel and multicomponent intervention program, compared to usual care. study design: implementation-effectiveness cluster randomized controlled trial we are conducting a hybrid type effectivenessimplementation, cluster randomized controlled trial (crct). we have randomly assigned health districts (clusters) to the intervention arm and to enhanced usual care (control arm) across five departments. we will enroll participants per health district and participants in total. after selecting eligible health districts, and before initiating participant recruitment, health districts were randomized and stratified by department, using a computerized random number generator. the trial flow chart is shown in fig. and the standard protocol items: recommendation for interventional trials (spirit) figure is shown in fig. . the spirit checklist is provided in additional file . the study follows minimum eligibility criteria to evaluate the intervention in a real-world setting. men and women years or older with uncontrolled hypertension, and who meet the following eligibility criteria will participate in the study: have uncontrolled hypertension, which will be ascertained by measuring bp at two screening visits, scheduled - days apart from each other. participants with stage ii hypertension (average systolic bp ≥ mmhg or diastolic bp ≥ mmhg) are eligible. participants with stage i hypertension (average systolic bp - mmhg or diastolic bp - mmhg) are eligible if they meet at least one of the following characteristics: ( ) taking antihypertensive medications; ( ) history of cardiovascular disease (myocardial infarction or stroke); ( ) estimated cardiovascular risk higher than % in years (based on the nhanes i follow-up study cardiovascular risk estimation) using a noninvasive prediction indicator [ , ] . live in a community served by one of the participating health posts and willing to receive hypertension care at the health post. be willing to sign an informed consent form before any study procedure is performed. for illiterate patients, a witness who reads and understands the consent will co-sign the informed consent form. individuals who have any of the following exclusion criteria will not be eligible to participate in the study: pregnant according to self-report diagnosed end-stage renal disease or any chronic terminal disease bedridden planning to move from the study area within the next months participants are being recruited from participating health posts and from the community in their catchment area. auxiliary nurses help study staff to identify potential participants and implement the intervention (see below), but do not participate in any study measurement. the study intervention is a multicomponent and multilevel program to improve hypertension control over months. the program is composed of one core intervention and five evidence-based implementation strategies (see fig. ) , which are defined as methods to enhance the adoption, implementation, and sustainment of the core intervention [ ] . the core intervention and implementation strategies were previously adapted to the rural guatemalan context by the study team and stakeholders from the ministry of health and local communities [ ] . physicians and nurses working at intervention health centers and auxiliary nurses working at health posts are responsible for delivering the intervention. the study team and ministry of health officials designed a standardized stepped-care hypertension treatment protocol summarized in an algorithm, based on the american heart association (aha) hypertension guidelines and the guatemala ministry of health healthcare norms [ , ] . after participants are enrolled in the study, health district physicians, nurses, and auxiliary nurses will establish an individualized treatment plan for the participant to reach a bp target < / mmhg, with a combination of antihypertensive medications offered by the ministry of health: hydrochlorothiazide, enalapril and losartan. the study team provided educational materials and pocket cards summarizing the hypertension treatment algorithm to healthcare teams of physicians, nurses, and auxiliary nurses from health posts and health centers will work collaboratively to establish a treatment plan for hypertensive patients. after study enrollment, a physician or nurse will perform a physical examination, confirm the hypertension diagnosis and select the initial anti-hypertensive medications following the standardized hypertension treatment protocol described above. auxiliary nurses from health posts (first level of care) will be in charge of follow up and health coaching sessions, and will coordinate and connect patients with physicians and nurses at the health center (second level of care). the collaborative team will meet at least monthly at the health center to discuss cases of uncontrolled hypertension or adverse events and make clinical decisions following the standardized hypertension treatment protocol. usual care provided by the ministry of health for patients with hypertension does not include team-based collaborative care. the study team provided an interactive -day workshop for physicians, nurses and auxiliary nurses, during the second semester of . training content included: bp management using a stepped-care protocol-based hypertension treatment; titration and adverse effects of antihypertensive medications; team-based collaborative care; and motivational interviewing skills to promote medication adherence and healthy lifestyle modifications during health coaching sessions. one month after the training, the study team conducted individualized field certifications on blood pressure measurement and health coaching sessions with auxiliary nurses working in health posts. periodic training will be provided to newly hired providers and as refreshers. usual hypertensive care does not auxiliary nurses conduct health coaching sessions focused on promoting adherence to anti-hypertensive medications, strategies to overcome treatment side effects and lifestyle modifications: reaching or maintaining a healthy weight, limiting sodium and alcohol intake, getting regular physical activity, and adopting an eating plan based on the dietary approaches to stop hypertension (dash). participants receive an educational flipchart adapted from the manual "healthy and happy heart" (corazon sano y feliz), previously developed and piloted in guatemala [ ] , and a card to register bp measurements. relatives will be encouraged to participate in health coaching sessions. during the first months of the intervention, health coaching sessions will take place monthly during the first months of the intervention. if the patient meets the bp target, the frequency will be reduced to every months. usual hypertensive care does not include health coaching sessions. after study enrollment, each patient receiving care at one of the intervention health districts obtains an electronic home bp monitor that stores readings with date and time stamp (omron hem- ). auxiliary nurses will teach patients and literate relatives to measure bp using the electronic monitor and document readings on a card provided by the study team. auxiliary nurses will review the patient card and document mean home bp-readings during the health coaching sessions, which the care team will use to guide hypertension management decisions. home bp monitoring is not part of usual hypertensive care. auxiliary nurses create lists of hypertensive patients documenting their anti-hypertensive medications, adverse events, and their controlled or uncontrolled status. then, auxiliary nurses take these lists to collaborative team meetings, where the group reviews cases and makes management decisions following the standardized hypertension treatment protocol. given that usual hypertensive care does not include completion of patient charts, the study team is providing paper-based forms for auxiliary nurses to generate the lists of patients with hypertension. blood pressure audit and feedback is not included in usual hypertensive care. healthcare providers based at the control health districts will receive a one-morning, -h training session on the ministry of health healthcare norms for hypertension management, conducted by ministry of health representatives. similar to the intervention arm, the study will provide one electronic bp monitor (omron hem- ) to each health center and health post. at the central government and department levels, the study team will work with ministry of health officials to promote the purchase, distribution and availability of essential hypertensive medications at participating health districts at a minimum. while participants in the intervention group receive an electronic bp monitor (omron hem- ) at the first study visit, those in the control arm will receive the bp monitor and study-specific educational materials at the last study visit. the primary clinical outcome is the -month difference in the proportion of participants with controlled hypertension (bp < / mmhg) between the intervention and control groups. the secondary clinical outcome is the -month net change in systolic and diastolic bp from baseline. the bp measurement for inclusion in the study and used in the outcome analysis will be standardized following the aha guidelines and conducted by trained study staff [ , ] . the clinical outcomes correspond to intervention effectiveness, measured at the individual participant level. we will also measure implementation outcomes as part of the second co-primary aim. the context-enhanced reach, efficacy, adoption, implementation, maintenance (re-aim)/ practical robust implementation and sustainability model (prism) framework will guide the evaluation of the implementation at the patient, provider, and health system levels. using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost effectiveness [ ] . the power calculation for the primary outcome was based on the following assumptions: ( ) a two-sided significance level of . ; ( ) statistical power of %; ( ) a proportion of patients with bp < / mmhg of % in the control group; ( ) detectable group differences in proportion of bp < / mmhg of % ( % of patients with bp < / mmhg in the intervention group); ( ) intra-cluster correlation (icc) coefficient for hypertension control of . ; ( ) clusters (health districts) per group; and ( ) % follow-up rate by months. the sample size for each cluster is based on a two-sample z test for individual-level comparison of a cluster design. further assuming an % follow-up rate by months, we will need to recruit participants from each district and study participants for the entire study. the statistical power is even higher for the secondary outcomes because they are continuous variables. table shows the statistical power based on various follow-up rates and iccs. the intra-cluster correlation over months was based on our data from the hypertensive control program in argentina (hcpia) [ , ] . we expect that each health district will enroll at least participants. given the longstanding engagement of ministry of health providers at the community level, we anticipate being able to successfully enroll the total number of participants. to enhance recruitment of participants, we have engaged healthcare providers and community leaders since the preparation phase of the trial. in addition, healthcare providers were familiarized with eligibility criteria and the enrollment process during training workshops and are referring potential study participants to study staff, who maintain constant communication with providers. the primary analysis will be conducted on an intention-to-treat basis. we will compare the proportion of participants who achieve bp control in the intervention arm and the control arm by using logistic mixed-effects regression analysis, where participants and clusters are included as random effects and the intervention group, time, and group-by-time interaction are included as fixed effects. in a secondary analysis, blood pressure values at baseline, months, months, and months will be modeled in a linear mixed-effects regression analysis. pre-defined subgroup analyses by age (< vs. ≥ years), sex (men vs. women), history of cardiovascular disease (cvd) (yes vs. no), and body mass index (< vs. ≥ kg/ m ) will be conducted. further details of the data management, statistical methods, and quality control plans are available upon request from the authors. we will use the context-enhanced re-aim/prism framework to evaluate the implementation of the multicomponent program [ , ] . the implementation evaluation will allow us to monitor and improve program implementation, understand the relationship between implementation characteristics and health outcomes, and design the dissemination plan if the program is proven effective. we will assess the expanded re-aim/prism dimensions at the patient, provider, and health system levels (see table ). in addition to the five dimensions of re-aim (reach, effectiveness, adoption, implementation and maintenance) we will assess the program fit and sustainability infrastructure of prism [ ] . the implementation outcomes that we will measure are: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost effectiveness [ ] . we will use a combination of quantitative and qualitative methods to assess the domains of interest. we will gather data during patients' study visits at , , and months. in addition, we will make regular ( - months) visits to healthcare facilities to capture study inputs and ongoing program implementation captured in checklists. in a subset of study sites, we will conduct interviews with participants and family members, providers, and public health administrators using semi-structured interview guides combined with chart-stimulated recall, shadowing, and direct observation. we will perform a cost-effectiveness analysis using the individual patient data collected at follow-up visits (see fig. ), expressed as incremental cost per additional percentage of patients that achieved hypertension control at months. intervention costs will include fixed costs such as education of health providers and salary of auxiliary nurses, and variable costs such as electronic bp monitors. healthcare costs will include ambulatory costs, such as drugs and laboratory tests, and hospital care (hospitalization). protocol-driven costs will be excluded. we will analyze differences in costs following a similar analytical approach as that used for estimating health outcomes [ ] . uncertainty around the incremental cost-effectiveness ratio (icer) will be estimated by bootstrapping techniques, and a % credible interval will be reported [ , ] . this is the first randomized cluster trial in central america to test the effect of a multicomponent intervention program for bp control in underserved rural populations. the intervention and study outcomes are patient- centered, and patients, ministry of health provider-teams, and other stakeholders have been engaged at every step of the proposed study. the multicomponent intervention program is designed to address barriers at the healthcare system, provider-team, and patient levels. the proposed study will generate urgently needed data on effective, adoptable, and sustainable intervention strategies aimed at reducing bp-related disease burden in central america and other low-income settings. although the efficacy and effectiveness of lifestyle modifications and antihypertensive drug treatment on the prevention of htn and consequent cvd risk have been demonstrated in randomized controlled trials, this knowledge has not been fully applied in lmic [ , ] . the proposed study will test whether an evidence-based, multilevel and multicomponent intervention program can be translated to and is feasible in the primary healthcare systems of this region. we will disseminate the study findings, promote scale up, and scale out of the program, if proven effective. this study will generate urgently needed data on effective, adoptable, and sustainable intervention and implementation strategies to improve hypertension control in guatemala and other low-and middle-income countries. a stakeholder engagement process and needs assessment are finalized. the study manual of operations was developed and training of study staff has been completed. the data safety and monitoring board met twice during : prior to study enrollment and during the first semester of enrollment. intervention educational materials for healthcare providers and patients were adapted and finalized. training workshops and field certifications of healthcare providers were developed and completed. the community advisory board was formed with local healthcare providers and hypertensive patients and has met twice. enrollment into the study began in july and % was completed by march th . enrollment has been paused due to covid- and will reinitiate as soon as a comparative risk assessment of burden of disease and injury attributable to risk factors and risk factor clusters in regions, - : a systematic analysis for the global burden of disease study global, regional, and national comparative risk assessment of behavioural, environmental and occupational, and metabolic risks or clusters of risks, - : a systematic analysis for the global burden of disease study global disparities of hypertension prevalence and control: a systematic analysis of population-based studies from countries national, regional, and global trends in systolic blood pressure since : systematic analysis of health examination surveys and epidemiological studies with country-years and · million participants risk factors for acute myocardial infarction in latin america: the interheart latin american study central america diabetes initiative (camdi): survey of diabetes, hypertension and chronic disease risk factors longterm effects of weight-reducing interventions in hypertensive patients: systematic review and meta-analysis physical activity in young adults and incident hypertension over years of follow-up: the cardia study effects of alcohol reduction on blood pressure: a meta-analysis of randomized controlled trials. hypertens (dallas, tex ) effect of longer-term modest salt reduction on blood pressure a clinical trial of the effects of dietary patterns on blood pressure. dash collaborative research group the dash diet, years later stakeholder engagement in the translation of a hypertension control program to guatemala's public primary health care system: lessons learned, challenges, and opportunities. glob heart competing demands of primary care: a model for the delivery of clinical preventive services barriers to detecting and treating hypercholesterolaemia in patients with ischaemic heart disease: primary care perceptions comparative effectiveness of implementation strategies for blood pressure control in hypertensive patients: a systematic review and meta-analysis effectivenessimplementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact the health system of guatemala an assessment of community health workers' ability to screen for cardiovascular disease risk with a simple, non-invasive risk assessment instrument in bangladesh laboratorybased versus non-laboratory-based method for assessment of cardiovascular disease risk: the nhanes i follow-up study cohort implementation strategies. in: dissemination and implementation research in health: translating science to practice acc/aha/aapa/abc/acpm/ags/apha/ash/ aspc/nma/pcna guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the american college of cardiology ministerio de salud pública y asistencia social. normas de atencion salud integral para primero y segundo nivel evaluation of a pilot hypertension management programme for guatemalan adults measurement of blood pressure in humans: a scientific statement from the outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda effect of a community health worker-led multicomponent intervention on blood pressure control in low-income patients in argentina: a randomized clinical trial comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in argentina re-aim planning and evaluation framework: adapting to new science and practice with a -year review using the practical, robust implementation and sustainability model (prism) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs evaluating the public health impact of health promotion interventions: the re-aim framework cost-effectiveness analysis alongside clinical trials ii-an ispor good research practices task force report pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation cost-effectiveness of a comprehensive approach for hypertension control in low-income settings in argentina: trial-based analysis of the hypertension control program in argentina the seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure: the jnc report international society of hypertension low and middle income countries committee: review of the goals of the committee and of years of ish activities in low and middle income countries publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors are grateful for support from all the ministry of health providers and staff that contributed to the adaptation and development of the study intervention, are implementing the study intervention and enhanced usual care activities, and patients and family members. national policies allow. this is study protocol version . and the version date is may . supplementary information accompanies this paper at https://doi.org/ . /s - - - .additional file . spirit checklist: recommended items to address in a clinical trial protocol.authors' contributions apa wrote the initial draft of the manuscript, incorporated authors' contributions, finalized the manuscript after edits and review by co-authors, designed and developed the tables and figures. km contributed to the development of fig. . vi and mrz wrote content and provided guidance as principal investigators. jh provided guidance as principal investigator. mf wrote content, reviewed the final version of the paper and provided critical review of the implementation science framework and table . rg provided critical review of the implementation evaluation content and table. all authors contributed to the conception and design of the study. all authors contributed to the reviewing and editing iterative drafts. all authors read and approved the final manuscript. research reported in this article was supported by the u.s. national heart, lung, and blood institute of the national institutes of health under award number u hl . the views expressed are those of the authors and do not necessarily represent those of the national heart, lung, and blood institute, the national institutes of health, the department of health and human services, or the u.s. government. upon completion of the trial, datasets used and analyzed during the study are available from the corresponding author on reasonable request. this study was approved by incap institutional review board (irb) and the guatemalan national health ethics committee. in addition, irbs from tulane university school of public health and tropical medicine, institute for clinical effectiveness and health policy in argentina and colorado school of public health approved the study. the study was registered at clinicaltrials.gov (nct ) on april . informed consent will be obtained from all participants. not applicable. the authors declare that they have no competing interests. key: cord- - hbbpmnt authors: strausbaugh, l. j. title: emerging health care-associated infections in the geriatric population. date: journal: emerg infect dis doi: nan sha: doc_id: cord_uid: hbbpmnt the increasing number of persons > years of age form a special population at risk for nosocomial and other health care-associated infections. the vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. the magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts. the elderly have defective host defenses that compromise their ability to ward off infectious agents; factors influencing immunocompetence include immune senescence, changes in nonadaptive immunity, chronic diseases, medications, malnutrition, and functional impairments. t-lymphocyte production and proliferation decline with age, resulting in decreased cell-mediated immunity and decreased antibody production to new antigens ( ) ( ) ( ) . thinning skin, enlarged prostate, diminished cough reflex, and other anatomic or physiologic accompaniments of aging are changes in nonadaptive immunity that render the elderly more vulnerable to infection. chronic diseases-cancer, atherosclerosis, diabetes mellitus, dementia-predispose to certain types of infection. medications such as sedatives, narcotics, anticholinergics, and gastric acid suppressants may further suppress innate defenses. malnutrition, which reduces cellmediated immunity, is common in nursing home residents ( ) and may be more common in the geriatric community at large than is generally realized ( ) . finally, functional impairments (e.g., immobility, incontinence, dysphagia) can complicate aging and enhance susceptibility to infection. these impairments may necessitate the use of urinary catheters, feeding tubes, and other invasive devices that magnify susceptibility. alone or in combination, these defects in host defense(s) place geriatric populations in the forefront of nosocomial infection statistics. data from the national nosocomial infections surveillance system for the period - indicated that persons years of age accounted for % of all nosocomial infections ( ) . similarly, gross and colleagues observed a decade-specific risk for nosocomial infection of per , discharges from birth through the fifth decade. however, this risk steadily rose from the fifth decade onward, exceeding infections per , discharges in patients > years of age ( ) . finally, saviteer and coworkers, who reported a similar increase in nosocomial infections after the fifth decade ( ), calculated daily nosocomial infection rates of . % and . % for persons aged < years and > years, respectively. the higher infection rates in the elderly were not attributable to increased lengths of stay. geriatric patients, like transplant recipients, may be compared to "sentinel chickens"-the first to be affected by new or emerging infections in hospitals and other health-care environments that care for adult patients. for example, the mean age of affected patients in a nosocomial outbreak of gastroenteritis caused by a small round-structured virus was years ( ) . the problem of tuberculosis (tb) deserves particular mention in the context of waning cell-mediated immunity. the elderly have not only this risk factor but also higher frequencies of latent infection, stemming from exposures during an era when tb was more prevalent. tb is the most the increasing number of persons > years of age form a special population at risk for nosocomial and other health care-associated infections. the vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. the magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts. commonly reported notifiable disease in persons > years of age ( ) . in , % of reported cases in the united states occurred in this age group. elderly persons living in the community have twofold increased rates of active disease. as a health care-associated infection in this age group, tb comes to the fore in hospital and nursing home outbreaks ( ) . elderly persons living in long-term care facilities have fourfold increased rates of active tb. the combination of decreased cell-mediated immunity and high prevalence of latent infection suggests that tb will continue to reemerge in geriatric populations. decreased cell-mediated immunity may also predispose geriatric patients to nosocomial cryptosporidiosis. a microbiologic review for a -bed hospital in rhode island identified patients with cryptosporidiosis ( ); of these patients were in the -to -year age group (mean years). in seven of these older patients, nosocomial acquisition was suspected. in addition, outbreaks of this disease have occurred in elderly nursing home residents ( ) . thus, cryptosporidium may be an emerging health care-associated infection in the aged. the lifestyles of the elderly may entail additional risk factors for both acquiring and transmitting health careassociated infections. in western countries retired persons use their increased leisure time to travel, including domestic trips to visit family, cruises or tours to foreign countries, or volunteer work in developing countries, which put elderly travelers at risk for infections. in addition, recreational activities such as golfing, spelunking, hunting, and gardening may bring the elderly into contact with unusual pathogens. volunteer work, visiting ill friends in the hospital, and other patterns of socialization also expose the geriatric population to infections that may be transmitted or acquired in the health care setting. several factors specifically related to health care deserve attention in this regard. the first concerns outpatient visits. the elderly spend increased amounts of time visiting their physicians, potentially exposing themselves to various contagious diseases in the health-care environment. they also make frequent use of food services and providers of prepared foods, which carry some risk for transmitting foodborne diseases. these infections may then enter the health-care system and lead to secondary cases. adult daycare centers and home care services, which have proliferated under medical auspices in recent years, provide additional avenues for geriatric populations to acquire health careassociated infections. the impact of these lifestyle factors on nosocomial and other health care-associated infections has not been well documented. several observations provide examples of the potential influence of these factors. a recent report from taipei described a nosocomial outbreak of malaria resulting from contamination of a computed tomography injection device with blood from a returning traveler ( ) . likewise, a outbreak of influenza in alaska and the yukon territories, where , to , tourists visit each summer, further delineated the potential role of travel ( ) . prospective surveillance in identified , cases of acute respiratory illnesses in hospitals and clinics in alaska and the yukon territory. among these illnesses, % of cases in tourists and tourism workers met criteria for influenzalike illness and . % for pneumonia. median ages were years for all persons with acute respiratory illnesses and years for all persons with pneumonia. fifty of the persons with pneumonia required hospitalization. the role of lifestyle factors related to health care has received little attention, but one recent publication illustrates the potential problem. a -year study of acute respiratory illnesses in three senior day-care centers documented the annual occurrence of viral respiratory infections in to elderly participants and to staff ( ) . identified pathogens included influenza a, influenza b, respiratory syncytial virus, coronavirus, parainfluenza virus, and rhinovirus. of special importance, an educational campaign stressing the importance of handwashing combined with use of a portable virucidal foam product cut the infection rate by % during the fourth year. this article describes a new setting for health care-associated infections and confirms that traditional approaches to prevention still apply. the spectrum of living arrangements for geriatric populations ranges from private residences in the community to skilled nursing homes. between these extremes are retirement homes, assisted living facilities, foster and group homes, chronic disease hospitals, and other arrangements that provide for the needs of persons with sustained self-care deficits ( ) . little is known about the role that these arrangements play in the overall scope of health careassociated infections. however, during the last years several studies have examined the problem of health careassociated infections in skilled-nursing homes ( , ) . nursing homes are residential facilities for persons who require nursing care and related medical or psychosocial services ( ) . approximately % of nursing home residents fall into the geriatric age range. as a group, nursing home residents exhibit virtually all the risk factors for infections associated with the geriatric population. as a consequence, infections occur commonly in this setting, and emerging health care-associated infections are no exception. three types of endemic infections occur regularly in all these facilities: urinary tract infections, lower respiratory tract infections-principally pneumonia, and various skin and soft tissue infections ( ) ( table) . in the united states, the overall rates for nursing home-acquired infection are to infections per , resident day, or . to . million infections per year ( ). occasionally, new etiologic agents crop up as causes of these endemic infections. for example, in a -year serologic study of selected pathogens causing respiratory tract infections and febrile episodes in two canadian long-term care facilities, orr and colleagues identified a positive serologic response to chlamydia pneumoniae in . % of febrile episodes ( ) . these positive responses were associated with % of respiratory infections, including of pneumonias and . % of infections of unknown origin. these data suggest that c. pneumoniae may be an emerging health care-associated infection in this setting. outbreaks also account for a proportion of the health care-associated infections observed in nursing homes ( , ) . respiratory infections and gastroenteritis occur most frequently. although no national data on frequency of occurrence are available, published reports suggest that outbreaks are not uncommon. during to , outbreak reports constituted approximately one-third of publications on infections in long-term care facilities ( ) . from to , the centers for disease control and prevention (cdc) received reports from states about foodborne outbreaks in nursing homes ( ) . of the outbreaks investigated by cdc's hospital infections program during the last decade, % occurred in long-term care facilities ( ) . emerging pathogens account for some of the outbreaks in nursing homes. during the last decade, streptococcus pyogenes-the "flesh-eating" bacterium-was identified in nursing homes ( ) . more recently, a foodborne outbreak of gastroenteritis caused by both salmonella heidelberg and campylobacter jejuni was reported ( ) . loeb and colleagues recently described an outbreak of respiratory illness caused by l. sainthelensi in two canadian nursing homes ( ) . these and other reports emphasize the vulnerability of frail, elderly residents who share common sources of air, food, water, and health care in nursing homes. health care-associated infections caused by antimicrobial drug-resistant bacteria have caused both endemic infections and outbreaks in nursing homes in the united states. the frequent movement of patients between hospitals and nursing homes undoubtedly facilitates the transfer of resistant microbes ( ) . during the last decades, gramnegative uropathogens with multidrug resistance and methicillin-resistant s. aureus have received the most attention ( ) . gram-negative enteric bacilli have recently become resistant to fluoroquinolones and extended-spectrum cephalosporins ( ) . in addition, vancomycin-resistant enterococci and penicillin-resistant pneumococci have been identified in long-term care facilities ( ) ( ) ( ) . the appearance of the latter organism, which is seldom regarded as a nosocomial pathogen, again underscores the unique situation of this health-care setting. because of the frequent interchange of patients between hospitals and nursing homes, infections caused by antimicrobial drug-resistant bacteria will continue to emerge in geriatric populations. recognition of such threats has prompted new interest in the prevention and control of infections associated with longterm care facilities. recent guidelines have addressed requirements for infection control programs, as well as influenza, antimicrobial use, and antimicrobial resistant pathogens ( , ( ) ( ) ( ) . although reports from the s described numerous deficiencies in infection control practices in nursing homes, recent reports have been more encouraging ( , , ) . a survey of long-term care facilities in new england indicated that % had persons dedicated to infection control activities for a median of hours per week ( ) . nevertheless, protection of the vulnerable elderly residents in nursing homes merits additional attention, and changes in nursing home licensure and certification requirements may be needed at both state and national levels ( ) . surveillance activity in less conventional care settings is a necessary first step in evaluating potential hazards. the vulnerable geriatric population plays a leading role in the scope of nosocomial and health care-associated infections. as the world's population ages, its role is likely to increase. as health care continues to move beyond hospital walls, the spectrum of health care-associated infections in the elderly will continue to expand, reflecting their multiple risk factors for infectious diseases. infection control practitioners and hospital epidemiologists are well advised to follow and study the aging population in the evolving health-care system. undoubtedly, they will find new opportunities to prevent health care-associated infections. in addition, they may be able to develop strategies to prevent the diverse contagions of the elderly from entering hospitals. dr. strausbaugh is hospital epidemiologist and staff physician, va medical center, portland, oregon; and professor of medicine, school of medicine, oregon health sciences university, portland, oregon. he is also the project director for the infectious diseases society of america emerging infections network, a cooperative agreement program sponsored by the centers for disease control and prevention. his research interests include surveillance for emerging infectious diseases and infection and antimicrobial resistance in long-term-care facilities. bacterial meningitis in the elderly prevention and control of nosocomial infections infections in the elderly epidemiology and prevention of infections in residents of long term care facilities clinical immunology of aging geriatric medicine and gerontology nosocomial infections in elderly patients in the united states, - nosocomial infections: decade-specific risk nosocomial infections in the elderly-increased risk per hospital day a viral gastroenteritis outbreak associated with person-to-person spread among hospital staff tuberculosis in elderly persons cryptosporidiosis: an unrecognized cause of diarrhea in elderly hospitalized patients diarrhea among residents of long-term care facilities a nosocomial outbreak of malaria associated with contaminated catheters and contrast medium of a computed tomographic scanner update: outbreak of influenza a infection-alaska and the yukon territory evaluation of a handwashing intervention to reduce respiratory illness rates in senior day-care centers serological study of responses to selected pathogens causing respiratory tract infection in the institutionalized elderly infections and infection risk in residents of long-term care facilities: a review of the literature, - foodborne disease outbreaks in nursing homes healthcare-associated outbreaks in the s: hospital infections program cdc group a streptococcal outbreaks in nursing homes a mixed foodborne outbreak with salmonella heidelberg and campylobacter jejuni in a nursing home two nursing home outbreaks of respiratory infection with legionella sainthelensi methicillin-resistant staphylococcus aureus in a nursing home and affiliated hospital: a four year perspective antimicrobial resistance in long-term-care facilities multiply antibiotic-resistant gram-negative bacilli in a long-termcare facility: a case-control study of patient risk factors and prior antibiotic use colonization with vancomycin-resistant enterococcus faecium: comparison of a long-term-care unit with an acute care hospital vancomycin-resistant eneterococcus faecium in a long-term care facility an outbreak of multidrug-resistant pneumococcal pneumonia and bacteremia among unvaccinated nursing home residents infection prevention and control in the longterm-care facility prevention of influenza in long-term-care facilities antimicrobial use in long-term-care facilities infection control programs in skilled nursing longterm care facilities a team approach to infection prevention and control in the nursing home setting infection control programs in long-term-care facilities: structure and process key: cord- -dc oyftd authors: koehlmoos, tracey pérez; anwar, shahela; cravioto, alejandro title: global health: chronic diseases and other emergent issues in global health date: - - journal: infectious disease clinics of north america doi: . /j.idc. . . sha: doc_id: cord_uid: dc oyftd infectious diseases have had a decisive and rapid impact on shaping and changing health policy. noncommunicable diseases, while not garnering as much interest or importance over the past years, have been affecting public health around the world in a steady and critical way, becoming the leading cause of death in developed and developing countries. this article discusses emergent issues in global health related to noncommunicable diseases and conditions, with focus on defining the unique epidemiologic features and relevant programmatic, health systems, and policy responses concerning noncommunicable chronic diseases, mental health, accidents and injuries, urbanization, climate change, and disaster preparedness. prevailing concerns and expected future trends, as seen clearly in the reemergence of tuberculosis and malaria as key health problems that have become global and individual country health priorities. infectious diseases have always had a decisive and rapid impact on shaping and changing health policy with global pandemics such as severe acute respiratory syndrome (sars) and h n , emerging without warning and challenging approved priorities within days if not hours. however, it is important not to lose sight of other areas of health and to maintain a close and watchful eye on trends and developments in those diseases that do not generate the immediate impact that some infectious diseases have been able to do. noncommunicable diseases fall into this group; they may not have garnered as much interest or importance over the past or years, but in fact have been affecting public health around the world in a very steady and critical way, becoming the leading cause of death in both developed and developing countries. this article discusses emergent issues in global health related to noncommunicable diseases and conditions. trying to offer an in-depth discussion on such a wide range of issues in just one article is clearly not possible, and therefore focus and emphasis is given to defining the unique epidemiologic features and relevant programmatic, health systems, and policy responses concerning noncommunicable chronic diseases (ncds), mental health, accidents and injuries, urbanization, climate change, and disaster preparedness. in the shadow of global efforts to achieve the millennium development goals (mdgs), by far the largest killer on the planet has continued to advance in low-income and middle-income countries. ncds cause % of all global deaths but receive just . % of international development assistance for health. approximately % of deaths caused by ncds occur in developing countries, generally in a younger population than those in high-income countries. , over the next years, the world health organization (who) predicts that ncd deaths will increase by % globally with the greatest increases in the african ( %) and the eastern mediterranean ( %) regions. in terms of the highest absolute number of deaths, the western pacific and south-east asia are projected to lead the field. noncommunicable diseases are a group of illnesses and include those conditions that have been identified as the leading causes of death around the world: heart disease, stroke, cancer, chronic respiratory diseases, and diabetes. these diseases are characterized by their long latency period often influenced by exposure to risk factors for extended periods over a patient's lifetime. the situation becomes more acute with the addition of the word "chronic," indicating that these diseases are mostly incurable and the duration of treatment may cover decades of a person's life. cardiovascular disease (mainly heart disease and stroke) is the biggest killer worldwide, contributing to % of global deaths each year. the importance of such a high figure can be seen in the countries that make up latin america and the caribbean, where cardiovascular disease alone accounts for % of the total mortality burden while aids, tuberculosis, malaria, and all other infectious diseases combined are responsible for only % of that burden. globally, chronic disease deaths have been predicted to increase by % between and . although research on multimorbidity has been based primarily on high-income countries, experts estimate that around % of the population living with chronic disease may actually be living with multiple chronic conditions. sometimes erroneously referred to as "lifestyle diseases," ncds are affected by a variety of risk factors that are often outside the control of the individual. there is very little that can be done about some risk factors, such as age and genetic inheritance, and increasing evidence suggests that what happens before a person is born and during early childhood plays a key role in the onset of adult chronic disease, demonstrated by the proven association between low birth weight and increased rates of high blood pressure, heart disease, stroke, and diabetes. however, the most common chronic diseases share some of the same highly preventable or avoidable risk factors including physical inactivity, tobacco use, and obesity, leading researchers to study mortality for ncds by risk factor. the who estimates that each year approximately . million people die from tobacco use, . million from being overweight or obese, . million as a result of raised cholesterol levels, and . million as a result of raised blood pressure. raised cholesterol and raised blood pressure (hypertension) are particularly dangerous risk factors because they can exist in an individual for a long time without presenting any obvious symptoms. in its seminal book preventing chronic disease: a vital investment, the who presents what it defines as effective and feasible interventions to reduce the threat of ncds, with low-income and middle-income countries being specifically targeted. the who seeks ideally to reduce the burden of ncd mortality by % per year through the implementation of the who framework convention on tobacco control (fctc), which was the first global treaty negotiated by the who in . as of it had been signed by nations, although stages of ratification vary. the fctc contains guidelines for implementing demand-reducing policies toward tobacco including health policies aimed at protecting the public with respect to commercial and other vested interests of the tobacco industry, protection from exposure to tobacco smoke, packaging and labeling of tobacco products; and limits or bans on tobacco advertising, promotion, and sponsorship. tax increases for tobacco control are considered to be clinically effective and very cost-effective relative to other health interventions, while the implementation of smoking bans in public areas appears to reduce the risk of heart attacks significantly, particularly among younger individuals and nonsmokers, according to a study published in the journal of the american college of cardiology (september , issue). researchers reported that smoking bans can reduce the number of heart attacks by as much as % per year. , policy level programs are also being discussed for reducing salt and sugared beverages , in the diet, consumer products, and food outlets. the who report also encourages screening for which there are clear public health benefits and cost benefit, and in situations in which the ability to treat the condition (such as raised blood pressure and cervical cancer) exists. however, at present the quality and quantity of research investigating the actual benefits of different intervention programs to prevent noncommunicable diseases in developing countries is sparse and exists primarily as case studies. , low-income and middle-income countries have developed their health provision and policies according to a primary care or alma ata model, focused on meeting the needs of pregnant women and children younger than years, and developing services for a variety of high-impact communicable diseases such as human immunodeficiency virus (hiv)/aids, tuberculosis, and malaria. the health systems in these countries are unprepared to deal with risk-factor education and behavior modification for the prevention, diagnosis, and treatment of ncds, or the long-term management of these conditions. despite growing interest among the population and health system leadership, one high-ranking health official pointed out that currently, donor countries are operating a policy ban on funding ncds, thereby starving low-income governments of the financial and technical assistance needed to turn around the ncd epidemic. this policy has to change, with overseas development assistance aligned to the priorities of recipient countries. this situation continues to be an issue for developing countries despite numerous calls for action in the area of ncds and funding. , , [ ] [ ] [ ] furthermore, there is a clear inequity inherent in noncommunicable diseases, as the poor and less educated are more likely to be exposed to several preventable risk factors including tobacco use, high-fat and energy-dense food consumption, physical inactivity, and obesity. there is no denying that noncommunicable diseases are linked to economic loss, and the who highlighted this in , predicting that national income loss due to heart disease, stroke, and diabetes for china, india, and the united kingdom are expected to be $ billion, $ billion, and $ billion, respectively, with part of the losses being the result of reduced economic productivity. the global burden of disease (gbd) project began in and since then chronic diseases have exceeded the burden of infectious diseases. despite this, the international community has yet to display a sense of urgency toward reducing ncds or supporting ncd-focused interventions in developing countries, even though they are threatening development and economic progress. perhaps the situation will change in the near future with the participation of united nations (un) member states in a highlevel summit on noncommunicable diseases scheduled to take place in new york in september . although nothing can be guaranteed, similar un summits have provided the catalyst for change, as seen following the summit on hiv/aids in that resulted in significant funding and political commitment to a coordinated action plan. since , the who has defined health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." however, mental illness and related conditions have never received the same importance or consideration as other areas of health despite their enormous burden on the population. this fact is exemplified by the routine exclusion of mental health services from primary health care (phc) and the absence of any mental health-related objectives in the mdgs. , mental illnesses, including behavioral, neurologic, and substance use disorders, affect a significant number of the world's population. in , the who estimated that globally million people suffered from depression, million from schizophrenia, and million from substance use disorders, with around , people committing suicide every year. in the same year, unipolar depressive disorders were ranked as fourth in terms of burden of disease, well on the way to prove the prediction of the gbd analysis that estimated mental illness, specifically unipolar major depression, would become the second leading cause of burden of disease by , second only to ischemic heart disease. studies in phc settings in turkey, the united arab emirates, france, vietnam, and zimbabwe revealed that the prevalence of mental illness ranges between % and % among adults, [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] with depression being the most common ranging from % to %, followed by generalized anxiety disorders ( %- %) and dependency on addictive substances ( %- %). [ ] [ ] [ ] children are not immune to mental health problems, with those aged between and years exhibiting a prevalence of mental illness of between % and %, , the most common diagnoses being anxiety disorders, major depression, behavioral disorders, and attention-deficit/hyperactivity disorder. , mental illness has an effect on other family members, which is seen clearly in a study looking at growth rates of children with mothers suffering from mental illness. the study showed that % of these children suffered from stunted growth, which could have been averted if interventions to treat the maternal depression had been performed. , individuals suffering from severe form of depression are at increased risk of attempting suicide, as are women who experience abuse. meanwhile, the prevalence of mental health problems among elderly people is %, the majority of whom suffer from depression. , cost-effective treatment for most mental illnesses exists and, if correctly applied, most patients become functioning members of society, leading normal lives even in low-resource areas, and suicide risk is reduced. of interest, poverty indicators are related to mental disorders - with low education level being the most influential determinant. extrapolating these data, it is feasible to suggest that developing countries with low education levels will tend to have a higher proportion of the population suffering from mental health problems. despite this, however, most low-income and middle-income countries spend less than % of their health expenditure on mental health. explicit mental health policy, legislation, mental health treatment facilities, and community care are all lacking. injuries as a global health issue include many types that are routinely reported to and published by the who, such as poisoning, falls, drowning, burns, and intentional injuries including interpersonal violence such as elderly, partner, or child abuse, and collective violence such as war. however, two of the most important injuries that contribute to high global death rates are road traffic accidents and occupational injuries. in , an estimated % of all global deaths were the result of an injury. injuries not only affect morbidity and mortality rates but also have a tremendous effect on the individual, the family, and the community. box presents the scope of injuries and their importance as a national health issue. it is predicted that by , road traffic injuries will be the fifth leading cause of death. already, approximately . million people die due to road traffic accidents each year, and an additional to million are injured or disabled. despite being home to fewer than % of the world's motor vehicles, low-income and middleincome countries have % of the mortality burden for road traffic accidents. one injuries prove to be the largest killer of children between and years of age, accounting for % of all classifiable deaths. this means that children per day die of injuries or children per hour. the leading cause of injury-related deaths among children is drowning ( . %) followed by road traffic accidents ( . %), animal bites ( . %), and suicide ( . %). it is estimated that injuries permanently disable around , children per year in bangladesh. nonfatal injuries occur in approximately million children per year or per minute (institute of child and mother health, ). when injury-related deaths are broken down by type and by age group, children aged - and - years are most likely to die from drowning with a mortality rate of per , and per , child deaths, respectively. in the - year age group, road traffic accidents account for per , child deaths, and in the - year age group, suicide accounts for per , child deaths. of the most important reasons for this apparent discrepancy is the high number of vulnerable road users in developing countries. vulnerable road users include pedestrians, cyclists, and both the rider and passenger of motorcycles and scooters. vulnerable road users account for % of deaths, and in low-income countries pedestrians account for nearly half of all road accident-related deaths. there are proven interventions that can lead to a reduction in the amount of road traffic deaths and injuries. such measures include controlling or reducing the speed of traffic with speed bumps or low-speed zones in urban areas, establishing and enforcing blood alcohol concentration limits, enforcing the use of helmets for both riders and passengers on motorcycles, and enforcing the use of seat belts, infant seats, and child booster seats. the wearing of seatbelts in automobiles can reduce front-seat passenger deaths by % to % and rear-seat passenger deaths by % to %; however, only % of countries require the wearing of seat belts by all passengers. the problem is that because of the high numbers of both people and different types of vehicles in developing countries and the lack of resources to police traffic effectively, traffic laws are not easily enforced, despite evidence showing the benefit of specific interventions in the reduction of traffic-related morbidity and mortality. occupational injuries are a significant problem in global public health, contributing to between , and , deaths worldwide each year. with great shifts in industrialization from the developed to the developing countries, it is logical that the highest number of occupational injuries is shifting in the same way toward the developing world. however, it is very likely that published figures are underestimated, with numbers probably being % below the actual figure for the united states and as much as % for some locations such as rural africa. , although several factors come into play when analyzing the causes of underreporting in developing countries, one of the main reasons is the lack of adequate data. determining the actual prevalence of occupational injury is critical for several reasons: ( ) to provide accurate data to health providers, policy makers, nongovernmental organizations (ngos), and the public; ( ) to provide baseline data against which to measure interventions; ( ) to aid priority setting and targeting for policy change and interventions; and ( ) to estimate societal costs of rising occupational injuries. tools to capture occupational injury have been designed and widely circulated by the un's specialized agency, the international labour organization. however, field testing of the tools has been limited to small-scale surveys in diverse settings such as vietnam, ghana, and bangladesh, - and larger, nationally representative studies are needed. in many developing countries, there is a lack of policy for or enforcement of safe working environments, which naturally means that wood cutting, mining, agriculture, construction, and manufacturing are more hazardous than in developed countries. the developed world has accepted that poor working conditions and practices are unacceptable and has legislated against them, leading to a reduction in occupational injuries over the past century. however, it seems that globally the same care has not been forthcoming, and developing countries have taken on the burden of heavy industry and poor working conditions that generate increases in occupational injuries. this trend is perfectly exemplified by the phrase "export of hazard" to describe when an outdated and dangerous technology is relocated from a high-income country to a developing country, despite the knowledge that the risk of injury with this technology is high. cost of production plays a key role in maintaining poor working conditions, and many industries in developing countries manage cost control through the use of manual labor, which is cheaper than the infrastructure and equipment needed to upgrade a process that produces the same amount of product at a much safer level. manual labor is particularly exploited in the construction industry in developing countries, which have a disproportionate number of deaths from workers falling and injuries from falling objects. working conditions at all levels of commerce are also full of risk factors to health, from the lack of ergonomically designed offices to avoid back injuries and repetitive stress disorders, to building materials used in construction, which may offer a long-term risk of health problems. the latter is of particular concern in many low-income and middle-income countries, with construction still making use of asbestos despite the documented links to lung cancer. , urbanization urbanization is a major public health challenge for the twenty-first century, with significant changes in our living standards, lifestyles, social behavior, and health. previously more of a phenomenon in developed countries; it is now taking hold and being seen at a greater level in developing countries. the united nations population fund (unfpa) predicts that over the next to decades, almost all the world's population growth will be in urban areas in developing countries. who figures for the period to already show an alarming increase in urban population growth, with developing countries' urban areas growing at an average of . million people per week or around , people every day. while urban settings offer many opportunities including access to better health care, they can affect existing health risks and introduce new health hazards. the living and working conditions of those living in rapidly expanding and poorly planned urban areas often experience risks to health in some of the most basic areas such as unsafe drinking water, unsanitary conditions, poor housing, overcrowding, hazardous locations, and exposure to extremes of temperature. these increases in health risks are particularly critical for those most vulnerable: children younger than years, infants, and the elderly. , the rapid growth of urban settlements is often due to poor economic performance of the area in question and lack of urban planning and regulation, which has resulted in an increase in the number and size of informal settlements or slums in many cities. it is estimated that in the developing regions, more than % of urban residents live in slums. the urban health situation the current pattern of urban growth is expected to have a multiplier effect on many dimensions of illness and disease. child mortality is already high in the urban areas of developing regions. in nairobi, where % of the city's population lives in slums, child mortality in these slums is . times greater than in other areas of the city. evidence from various surveys and studies points to a heavier burden of diseases such as diarrheal diseases, acute respiratory diseases, malnutrition among children, hiv/aids, tuberculosis, malaria, diabetes, and obesity on the urban poor. , , migration, increased mobility, changes in the ecology of urban environment, high population density, poor housing, and poor provision of basic services all act as pathways for emerging and reemerging communicable diseases. , the consequence of these changes is evident in the spread of multidrug-resistant strains of tuberculosis that is placing the urban poor of india, indonesia, myanmar, and nepal at a higher global health risk. vector-borne diseases such as dengue and malaria are also increasing in many urban areas, due to migration, climate change, stagnant water, insufficient drainage, flooding, and improper disposal of solid waste. , unhealthy lifestyles characterized by unhealthy nutrition, reduced physical activity, and tobacco consumption due to rapid and unplanned urbanization are associated with common modifiable risk factors for chronic diseases such as hypertension, diabetes mellitus, and obesity. urban environments tend to discourage physical activity and promote unhealthy food consumption. overcrowding, heavy use of motorized transport, poor air quality, and lack of safe public spaces are some urban factors that restrict participation in physical activities. in the larger populated cities of asia obesity is becoming a significant problem, and the rapid transition of diets in developing countries is typified by the coexistence of child malnutrition and maternal obesity in the same household. one of the main factors identified as causing an increase in diabetes worldwide is the change in traditional diets caused by urbanization. urbanization is exacerbating the health risks in terms of traffic accidents, injuries on the street or in the home, and mental health problems. the changes in climate and rising sea levels work toward increasing urbanization, with million people living in the low-elevation coastal zones being at heightened risk of flooding, which will lead to migration to higher elevations and larger cities. adopting preventive measures to control communicable diseases, upgrading the infrastructure of existing health facilities, increasing human resource capacity, and taking appropriate measures for providing equitable health services to all, especially the most vulnerable groups, are vital for improving urban health. recently, the who identified key areas of action for improving urban health: . promote urban planning for healthy behaviors and safety . improve urban living conditions, including access to adequate shelter and sanitation for all . involve communities in local decision making . ensure cities are accessible and age-friendly . make urban areas resilient to emergencies and disasters. however, these actions will only be effective if there is strong collaboration between health authorities, urban planning agencies, environmental agencies, energy providers, and the transportation systems. climate change is an emerging threat to global public health. it is now widely accepted that climate change is occurring as a result of emission of greenhouse gases, especially from fossil-fuel combustion. climate change is predicted to affect many natural systems and habitats, for example, increasing the frequency and intensity of heat waves, increasing the number of floods and droughts, altering the geographic range and seasonality of certain infectious diseases, and disturbing food-producing ecosystems, which in turn will affect human health both directly and indirectly. direct health effects include changes in mortality and morbidity, and changes in respiratory diseases from heat waves. in terms of indirect health effects, these are much more extensive and include changes in the distribution of vector-borne diseases, the nutritional and health consequences of regional changes in agricultural productivity, and the various consequences of rising sea levels, flooding, and droughts. [ ] [ ] [ ] climate change is highly inequitable, and the paradox is that those at greatest risk are the poorest populations in developing countries who have contributed least to koehlmoos et al greenhouse gas emissions. however, the rapid economic development and concurrent pollution means that developing countries are now vulnerable to adverse health effects from climate change and, simultaneously, are becoming an increasing contributor to the problem. , although the effects of climate change affect all levels and ages of any single population, the elderly and those with preexisting medical conditions are seen as being the most vulnerable. conversely, major diseases that are most sensitive to climate change such as diarrhea, malaria, and infection associated with malnutrition are most serious in children living in poverty, making them highly vulnerable to the resulting disease burden. heat waves are expected to increase the occurrence of heat-related illnesses such as heat exhaustion and heat stroke, and aggravate existing conditions related to circulatory, respiratory, and nervous system problems, especially among the elderly. , in , a major heat wave affected most of western europe and caused additional deaths in england and wales. another consequence of high temperatures is that they raise the levels of ozone and other air pollutants, which in turn aggravate respiratory diseases such as asthma. meanwhile, health impacts due to natural disasters, such as floods, droughts, and storms, range from immediate effects that include physical injury, mortality and morbidity, and communicable diseases, to possible long-term effects such as malnutrition and mental health disorders. from to , flooding was the most frequent natural disaster ( %), killing almost , people and affecting over . billion people worldwide. droughts increase the risk of food shortages and malnutrition, and increase the risk of diseases spread by contaminated food and water, because viral load increases in water sources when levels drop dramatically. rising temperatures, irregular rainfall patterns, and increasing humidity affect the transmission of many vector-borne and water-borne diseases such as malaria, dengue, cholera, and other diarrheal diseases. vector-borne diseases currently kill approximately . million people each year while . million die from diarrheal diseases. studies suggest that by , climate change may put million people in africa at risk of malaria, , and by the s the global population at risk of dengue is likely to increase to billion. , recent published data provides evidence of an association between the el niñ o and la niñ a phenomena, which are major determinants of global weather patterns, and some infectious diseases. evidence shows that there is an association between el niñ o and malaria epidemics in parts of south asia and south america, and with cholera in coastal areas of bangladesh. , studies of malaria have already revealed the health impacts of climate variability associated with el niñ o, including large epidemics on the indian subcontinent, colombia, venezuela, and uganda. one of the most immediate problems related to changes in climate and climate patterns is that on food production and availability. each year approximately . million people, mostly children from developing countries, die from malnutrition and related diseases. it is projected that climate change will decrease agricultural production in many tropical developing regions, thus putting tens of millions more people at risk of food insecurity and adverse health consequences of malnutrition. disasters in certain areas of high food production will also affect global prices, thereby affecting not only those people living in the affected region but others around the world who depend on food produced from that region. the who gbd study in indicated that the climatic changes that have occurred since the mid- s would be having an effect by the year , with , deaths ( . % deaths globally each year) and . million lost disability-adjusted life years (dalys) per year ( . % global dalys lost per year). the estimated effects are predicted to be most severe in those regions that already have the greatest disease burden of climate-sensitive health outcomes, such as malnutrition, diarrhea, and malaria. , , many of the projected impacts on health are avoidable, and public health policy makers need to act to reduce or negate the impact caused by climate change through a combination of short-term public health interventions that aim to adapt measures in health-related sectors, such as agriculture and water management, and long-term strategy. the most effective responses are likely to be strengthening of the key functions of environmental management, surveillance and response to protect health from natural disasters and changes in infectious disease patterns, and strengthening of the existing public health systems. , however, countries need to assess their main health vulnerabilities and prioritize adoptive action accordingly, keeping in mind the costs involved. natural disasters know no boundaries, and any nation or population can be subject to a catastrophic disaster at any time. however, some nations and populations are more at risk of disasters than others due to geographic location, poverty, and several sociopolitical factors. this issue of disaster risk reduction (drr) rose to global prominence in the aftermath of the tsunami in the indian ocean in december . following a disaster, some populations suffer more acutely than others. it is worth considering the complex issues of how societies organize themselves in terms of risk and actual prevention and care, for access to clean water and sanitation, and how they communicate and initiate behavioral change among the displaced or fragile populations. at the forefront of most discussions when planning post-disaster management and action is the priority placed on certain elements of disaster relief, such as the building of embankments, the distance to clean water, or the time from incident to response. recent examples of varying responses and outcomes were seen following the two cyclones in south asia. there was a relative success in bangladesh in terms of lives saved and response coordination after cyclone sidr in november , compared with the devastating loss of more than , lives after cyclone nargis in myanmar in may , not to mention the loss of draft animals and dykes, and the flooding of fields during planting season. bangladesh reverted to its welldeveloped program for drr that includes national-level coordination, whereas in myanmar there was no national platform for disaster preparedness, and delays occurred in the coordination of international response to the disaster. in addition to the immediate and obvious impact of natural disasters, conditions often worsen in poorly coordinated settings, as evidenced in when vibrio cholerae emerged in post-flood pakistan, and for the first time since the s in post-earthquake haiti. in general, there are factors that can turn a natural disaster into a complex disaster regardless of the severity or magnitude of the initiating event such as a hurricane, earthquake, or tsunami. according to the un department of humanitarian affairs, the factors are: poverty, ungoverned population growth, rapid urbanization and migration, transitional cultural practices, environmental degradation, lack of awareness and information, and war and civil strife. poverty is by far the single greatest factor that contributes to the vulnerability of a population to complex disasters. in addition to lacking financial resources to prepare for or recover from a disaster, impoverished people are also more likely to have low levels of education and low amounts of political influence to properly deal with a disaster situation. in addition to increases in birth rates, rapid population growth can be the consequence of urbanization or migration. population growth without limits produces a population that is more likely to settle in areas that are unsuitable or at risk for natural disasters, meaning that more people are at risk of disease and, most importantly, are more likely to undergo civil strife while competing for scarce resources. as mentioned previously, rapid urbanization and migration lead to impoverishment. former rural populations make themselves more vulnerable to disaster by settling in less developed or high-risk city environs, often leading to homelessness or living in urban slums that have circumvented any planning controls or regulations. such populations therefore are made more vulnerable to floods, landslides, and the destruction of their dwelling during a hurricane or earthquake. transition of cultural, economic, or government practices such as the increase in migration from rural to urban areas, economic advancements, families moving away from traditional support networks and to unfamiliar surroundings, and the shift from an agrarian to an industrialized society leave certain societies vulnerable to natural disasters. environmental degradation can play a role by either causing or exacerbating a disaster. for example, deforestation can work in two ways: firstly enabling runoff or secondly, making landscapes vulnerable to storms, due to lack of natural wind breaks. everyone is aware of the natural conditions that provoke droughts, but through the construction of dams, unchecked urbanization, implementation of poor cropping patterns, and the depletion of water supplies, man-made droughts are becoming more widespread. it is clearly of upmost importance to ensure that populations are informed about what to do to prepare in advance of a natural disaster such as a hurricane, and also are able to fend for themselves following the event. a lack of awareness and the dissemination of accurate information is a major factor that can turn one disaster into a multiple or complex disaster involving, for example, subsequent outbreaks of cholera, malnutrition, and physical injury. war and civil strife are extreme events that can both produce disasters or be caused by disasters, normally as a result of the preceding factors. the phrase for disasters that specifically strike war-torn populations is complex humanitarian emergencies. global efforts to address and capture the importance of disaster risk and poverty have been hampered by a lack of data, especially from asia, latin america, and the caribbean. empirical evidence linking disaster risk to poverty tends to come from microstudies within one community, making it impossible to generate generalized findings across regions or entire countries. prompted by the devastation that followed the tsunami on december, , there was widespread acceptance that an early-warning system should be installed and other actions taken to prevent loss of life where possible. the world conference on disaster reduction was held in japan in january , and resulted in the creation of the hyogo framework for action - (hfa), which was endorsed by un member states and urges all countries to make major efforts to reduce their disaster risk by . the hfa outlines the need to increase awareness and understanding about drr, the importance of knowing the real and potential risks, and taking action against them. specific recommendations included the need to create or enhance early-warning systems, build drr into education, and reduce risk factors such as deforestation, unstable housing, and the location of communities in risk-prone areas. although different areas of the planet experience different risks, the one common factor is that drr "concerns everyone, from villagers to heads of state, from bankers and lawyers to farmers and foresters, from meteorologists to media chiefs." to support common needs within regions, associations and networks have been established to support drr, such as the south asian saarc disaster management center and the caribbean disaster emergency response agency. types of activities that can feature in a national or regional drr program can include: establishing early-warning systems; using local knowledge of events; building an awareness of risk and risk preparedness through community activities; building flood-resistant buildings and safe homes; developing contingency plans; helping communities and individuals develop alternative sources of income; and establishing insurance or microfinance programs to help transfer the risk of loss and provide additional resources to the community. in addition to chronic diseases, mental health problems, injuries, and complex disasters, communities should consider increasing risks from more than new or reemerging diseases that have appeared since the s: liver disease due to the hepatitis c virus; lyme disease; food-borne illnesses caused by escherichia coli o :h ; cyclospora, a water-borne disease caused by cryptosporidium; hantavirus pulmonary syndrome; and human disease caused by the avian h n influenza virus. the increasing number of new and reemerging diseases is not the only risk factor that should be added to the planning processes for developing a drr program. drug resistance in treating many diseases and illnesses is a major concern, as witnessed in malaria and tuberculosis, and with a highly mobile world population, global pandemics such as sars, h n , and h n , for which treatments either are not available or levels of suitable drug are clearly not sufficient for a worldwide epidemic, are proving to be very challenging. this clear inability to predict and maintain sufficient levels of treatment for potential threats makes health risk reduction extremely difficult, and in developing countries where resources are already stretched to cope with existing health issues, creating effective programs will require intervention from social partners, global support organizations, and aid from the developed world. an ever quickening pace of globalization means that public health-related problems in one area of the world will have an impact on those living in another area and therefore, it is in everyone's interest to ensure that all countries, irrespective of their economic development and available resources, are sufficiently supported to maintain and review strategies that will effectively reduce morbidity and mortality rates in all spheres of public health. preventing chronic diseases: a vital investment a race against time: the challenge of cardiovascular disease in developing economies non-communicable diseases: time to pay attention to the silent killer. press release missing in action: international aid agencies in poor countries to fight chronic disease when people live with multiple chronic diseases: a collaborative approach to an emerging global challenge the developmental origins of chronic adult disease world health organization framework convention on tobacco control [who fctc]. guidelines for implementation 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evolution of complex disasters united nations-international strategy for disaster reduction united nations-international strategy for disaster reduction [un-isdr] living with risk. a global review of disaster reduction initiatives disaster risk management and climate change adaptation in south asia. dhaka: portfolion new and reemerging diseases: the importance of biomedical research key: cord- -ivczo a authors: brown, m. m. title: don’t be the “fifth guy”: risk, responsibility, and the rhetoric of handwashing campaigns date: - - journal: j med humanit doi: . /s - - - sha: doc_id: cord_uid: ivczo a in recent years, outbreaks such as h n have prompted heightened efforts to manage the risk of infection. these efforts often involve the endorsement of personal responsibility for infection risk, thus reinforcing an individualistic model of public health. some scholars—for example, peterson and lupton ( )—term this model the “new public health.” in this essay, i describe how the focus on personal responsibility for infection risk shapes the promotion of hand hygiene and other forms of illness etiquette. my analysis underscores the use of constitutive and stigmatizing rhetoric to depict individual bodies, rather than environments, as prime sources of infection. common among workplaces, this rhetoric provides the impetus for encouraging individual behavior change as a hedge against infection risk. i argue, though, that the mandating of personal responsibility for infection risk galvanizes a culture of stigma and blame that may work against the aims of public health. signal that a pandemic [was] imminent.^so, the th day's headlining issues of economic recovery, job creation, and the wars in afghanistan and iraq came second to obama's discussion of h n , the pandemic strain of the influenza virus. obama opened his remarks, for example, by outlining the steps that his government had taken to protect the american people from the devastations of outbreak. measures adopted to fend off h n included carefully monitoring the spread of the novel strain and stockpiling medical supplies and drug treatments. on the advice of public health experts, the u.s. government had also considered closing public schools in response to suspected or confirmed cases. obama also urged parents and employers to develop contingency plans if the spread of h n led to massive workplace and school closures. band finally,^obama continued, bi've asked every american to take the same steps you would to prevent any other flu: keep your hands washed, cover your mouth when you cough, stay home from work if you're sick, and keep your children home from school if they're sick.^adopting these various forms of illness etiquette, obama implied, demonstrated one's assumption of personal responsibility in response to the heightened risk of infection. this essay contributes to the ongoing examination among rhetoricians of health and medicine of constructions of responsibility and risk. specifically, i explore the centrality of a rhetoric of personal responsibility to discursive efforts to manage infection risk. health humanities scholars and rhetoricians of health and medicine share a common concern for the ethical issues that arise from risk-management exercises undertaken in the name of public health. practitioners, too, have a stake in more detailed understandings of the impact of risk discourse on the formation of health subjectivity. however, as keränen ( b) explains in the health humanities reader, ba rhetorical perspective focuses on how specific symbolic patterns structure meaning and action^in health and public-health contexts ( ). writing for this journal, for example, ding ( b) stresses the economic and sociocultural effects of media portrayals of bat risk^populations during severe acute respiratory syndrome (sars). my essay contributes to this scholarship with an account of how messaging that seeks to engage publics in outbreak management shapes their perceptions of responsibility and risk, not to mention of public health. as i argue, handwashing campaigns reinforce an individualistic model of public health, one premised to a significant extent on the necessity of behavior change rather than structural intervention. some scholars-for example, peterson and lupton ( ) -term this model the bnew public health.p ersonal responsibility serves essential functions in response to the threat of infection. however, the mandating of personal responsibility for infection risk has the potential to galvanize a culture of stigma and blame. too narrow a focus on personal responsibility may also diminish perceptions of the effectiveness of improved structural supports for those infected. during h n , for example, universal paid sick leave became a topic of debate, serving as a reminder of the need for an environment supportive of individual efforts to manage infection risk. in this essay, i characterize hand hygiene promotion as both a bconstitutive rhetoric^and a bstigmatizing rhetoric.^whereas a constitutive rhetoric encourages action through the cultivation of subjectivity, a stigmatizing rhetoric uses stigma to shape perceptions-also typically for the sake of influencing behavior change. i also describe how scholars of rhetoric of health and medicine have employed these two theories and explain their value to health humanities practitioners and scholars. i then examine the uses of constitutive and stigmatizing rhetoric in a u.s. state-level campaign to enforce bhygienic norms^(including, importantly, hand hygiene) within the workplace. my analysis reveals the centrality of stigma and blame to these efforts to encourage the assumption of personal responsibility. research on hand hygiene promotion finds that handwashing campaigns have a proven impact on health behaviors and thus, by extension, on health outcomes. so, why might those of us who have been exposed to these campaigns concern ourselves, perhaps unnecessarily, with their implications for our views of risk, responsibility, and public health? the reason i turn to in my conclusion is that the rhetorical means used to encourage personal responsibility may obscure perceptions of more effective approaches to the management of infection risk. handwashing campaigns also create opportunities to profit from and even exploit the stigma and blame that these texts associate with failures of personal responsibility. my goal, then, is mainly to explore the limits of personal responsibility-not just as an approach to infection risk, but more generally as a cornerstone of twenty-first-century public health. personal responsibility may be a cornerstone of public health, but hand hygiene promotion is an especially persuasive vehicle for popularizing an individualistic conception of infection risk. by bhand hygiene promotion,^i mean efforts to instruct a broad, lay public in hygiene practices typically used to reduce the transmission of disease-causing pathogens in hospitals and clinics. in this essay, i use bhandwashing campaigns^and bhand hygiene promotionî nterchangeably to describe the discursive encouragement of this habit. i also focus mainly on hand hygiene promotion within north america, where amid h n handwashing campaigns and hand hygiene products alike became endemic. commenting on this trend in a new yorker essay, owen ( ) links the phenomenal success of gojo industry's blockbuster hand sanitizer, purell, to anxieties about infection risk. today, hand sanitizer is a product category in its own right, and its popularity is sometimes regarded critically as both indicative of and responsible for a distinct shift in cultural perceptions of infection risk. in my view, however, purell's unprecedented sales figures are inextricably tied both to the increased promotion of hand hygiene in recent decades and to the ongoing individualization of public health. a drawback of undertaking a critique of hand hygiene is appearing to be against hand washing and other expressions of illness etiquette. hand hygiene is a vital form of infection control, and as such, it is also an ethical practice, particularly during an outbreak. rather than argue against hand hygiene, i explore the limits of hand hygiene promotion, as well as its implication in the deepening entrenchment of the new public health. in this respect, my essay draws its inspiration from the work of metzl, who in the introduction to his co-edited multidisciplinary anthology against health, writes that health is a bdesired state, but it is also a prescribed state and an ideological position^( , ). the same argument applies to public health, which broadly speaking entails the strategic, organized effort to bpersuade a defined public to engage in behaviors that that will improve health or refrain from behaviors that are unhealthy^ (springston , ) . hand hygiene promotion especially invites further scrutiny because its prescriptive, ideological qualities far too often go unnoticed. hence, i focus my attention here on describing how handwashing campaigns benefit the overarching emphasis on personal responsibility for infection risk. an important precedent for my critique is plyushteva's analysis ( ) . plyushteva examines the promotion of hand hygiene in developing countries, which she sees as having applications beyond the potential reduction high mortality rates due to infection. in fact, just as in north america, hand hygiene promotion directed at publics in developing countries aims to empower these publics to protect themselves from the risk of infection. since , for example, global handwashing day has been celebrated annually on october . an initiative of the global public-private partnership for handwashing with soap (global ppphw), global handwashing day is bdedicated to increasing awareness and understanding about the importance of handwashing with soap as an effective and affordable way to prevent diseases and save lives.^the celebration also presents ban opportunity to . . . encourage people to wash their hands^-or, as explained in a global handwashing day press release, to inspire personal responsibility. in developing countries, hand hygiene promotion's emphasis on personal responsibility may affect perceptions of entitlement to care. indeed, global handwashing day presents infection risk as managed not through the provision of clean water or proper sanitation but rather through the adoption of appropriate personal measures. underwritten by an array of corporate sponsors, global handwashing day also teaches people living in developing countries to become faithful consumers of hand sanitizer and soap, just like their counterparts in developed countries. current sponsors include colgate-palmolive, procter and gamble, and unilever, all companies with a massive stake in the global marketplace for personal hygiene products. (corporate sponsors may also have influenced the naming of the global public-private partnership for handwashing with soap. even the scholarship produced by the researchers working for this partnership typically includes this addendum.) global handwashing day's instruction in the consumption of personal hygiene products, too, has ties to the overarching emphasis on personal responsibility that defines the new public health. hand hygiene is promoted as a bdo-it-yourself vaccine,^a hedge against infection risk (apparently) even in settings in which infection risk often stems from poor sanitation and lack of access to clean water. of course, regardless of context, hygiene habits have a proven impact on the transmission of disease-causing pathogens. hand hygiene limits the spread of diarrheal and respiratory diseases, which are among the leading causes of child mortality in developing countries. children thus comprise a key audience for global handwashing day, which seeks to transform them into bchange agents^who have the capacity to bpositively influence other people's health behaviours^ (global ppphw ) . however, as plyushteva observes, global handwashing day's celebration of the life-saving power of individual behavior change potentially obscures understandings of the structural factors that shape infection risk. in developing countries, for example, the spread of disease stems from lack of access to clean water and adequate waste disposal and not mainly from a lack of agency per se. in tying infection risk to the bsuboptimal behaviour of the poor^( , ), handwashing campaigns in developing countries exacerbate longstanding power imbalances, potentially reinforcing rather than removing obstacles to meaningful change. at the same time, hand hygiene promotion in this context expands the global marketplace for personal hygiene products, forging new opportunities to profit from the intractable problem of infectious disease. plyushteva's analysis is helpful to my own because she draws attention to hand hygiene promotion's insidiousness and stresses its consequent potential to serve a range of motivations. some of these motivations in fact conflict with the aims of public health, particularly in developing countries. bat first glance,^she argues, bthe cause of handwashing appears as apolitical and uncontroversial as can be^( ). so unproblematic is hand hygiene, and so important are efforts to promote it, that the very few criticisms of global handwashing day have largely been ignored. for her part, plyushteva takes issue with the celebration's stigmatizing of people in developing countries bas traditional or backward, or, in a teleological view of development, pre-modern^( ). hand hygiene's buncontroversial façade^( ) also obscures the reality that individual behavior change is only ever a bpartial solution^( ) to the spread of disease. efforts to quell the spread of disease through behavior change also depend on the implementation of structural interventions-changes that create an environment supportive of personal responsibility. (i return to these limitations of personal responsibility in my conclusion.) i quote plyushteva at length because hers is the most recent scholarly critique of contemporary, globalized efforts to promote hand hygiene promotion. her writing establishes a precedent for my critique of north american handwashing campaigns, which may also do more, politically and economically, than simply diminish the risk of infection. circulated within workplaces, schools, transit hubs, airports, community centers, groceries stores, and shopping malls, handwashing campaigns portray individual bodies, and body parts, as dangerous vectors of infectious disease. what makes these bodies, and parts, dangerous is both that they spread infection and because the disease-causing pathogens they transmit remain invisible to the individuals who transmit them. as a caption for a handwashing poster created by yale university's emergency management department in , in response to h n , puts it, byou've got a mystery on your hands.t aking the form of pamphlets, posters, transit ads, web infographics, social media campaigns, and public service announcements, these texts caution that the power to prevent (and spread) infection is in our hands. sales figures for hand sanitizer alone illustrate the impressive new revenue streams generated by this individualization of infection risk. even in developed countries, where the assumption of personal responsibility is less likely to be impeded by structural issues, hand hygiene promotion may nevertheless skew perceptions of contextual or social determinants of infection risk. most notable among these factors may be the availability of sick leave or the effects on susceptibility of feelings of anxiety or stress. hand hygiene promotion invariably serves two distinct purposes. at one level, as exercises in risk communication, handwashing campaigns satisfy the obligation to inform publics about how to diminish the risk of infection. the most effective display of hand hygiene promotion's function as a form of risk communication may be the infographics, often posted in public restrooms, that illustrate the handwashing procedures practiced by healthcare professionals. these infographics teach handwashing methods, but they also serve to emphasize the need for personal responsibility in public settings. indeed, at another level, many handwashing campaigns often serve more expressly rhetorical goals. the most effective-and the most problematic-is the use of hand hygiene promotion to exacerbate a whole host of negative emotions, from anxiety, distrust, fear, and doubt to nausea and disgust. some of the most prominent voices behind the turn to hand hygiene promotion, particularly in developed countries, have emphatically defended the rhetorical utility of public health campaigns that inspire feelings of disgust. in my close reading, i focus more on this latter function of handwashing campaign-that is, its use to foster emotional states that predispose audiences to the adoption of personal responsibility. hand hygiene promotion's alignment with an axiom of neoliberalism-the emphasis on personal responsibility-is also worthy of further examination. harvey describes the typical characteristics of the neoliberal state and explains, the bsocial safety net is reduced to a bare minimum in favour of a system that emphasizes personal responsibility. personal failure is generally attributed to personal failings, and the victim is all too often blamed^ ( , ) . harvey's account stresses the economic advantages of the neoliberal emphasis on personal responsibility. indeed, a neoliberal approach to infection risk has both shifted attention away from costlier programs of outbreak management and accorded private stakeholders unparalleled economic advantages. arguably, the main benefactors of personal responsibility for infection risk are the corporations that develop and distribute products in support of illness etiquette. yet the recent popularity of hand sanitizer does more than reflect the successful marketing of hand hygiene as an antidote to both uncertainty and infection. rather, this shift in consumptive patterns also illustrates the tremendous impact of handwashing campaigns on a risk-oriented subjectivity. alongside promoting a habit that may reduce the transmission of disease, handwashing texts heighten awareness of those who fail in their duty to limit the spread of infection. noncompliance with the dictates of hand hygiene promotion becomes grounds not merely for blame but also for suspicion about a person's moral worth. contemporary handwashing campaigns thus form a constitutive rhetoric, a mode of rhetorical appeal that calls into existence a shared collective identity. within hand hygiene promotion, the collectivity identity called into existence is that of the health citizen for whom participation in containing an outbreak is a personal responsibility. white describes bconstitutive rhetoric^(a term that he coined) as bthe central art by which culture and community are established, maintained, and transformed^ ( , ) . scholars use constitutive rhetoric to explain the discursive formation of new social and political subjectivities. in demonstrating how some rhetorics discursively constitute the very subjects they address, many critics follow charland's model of constitutive rhetoric ( ) . into white's theory, charland incorporates burke's notion of identification ( ) and althusser's idea of interpellation, or bhailing^( ). as charland observes, constitutive appeals produce and reinforce new subject positions ( ) . by responding to these appeals, individuals affirm their membership in the community. constitutive rhetoric has been a useful analysis for health humanities scholars and practitioners. anthropologist joseph dumit, for example, argues that strategies employed in pharmaceutical discourse create new opportunities for marketing drugs by constituting the individual as a body at risk of disease ( ). the strategic constitution of bodily risk, dumit argues, is essential to keeping americans on bdrugs for life.^scholars of rhetoric of health and medicine have employed constitutive rhetoric to critique the interpellation of headache patients as well as of patients as narrative subjects (segal ). derkatch has used constitutive rhetoric to account for the maintenance of professional boundaries in medicine ( ), whereas kopelson has shown in response to breast cancer, public health organizations mobilize citizens as consumer-activists ( ). majdik and platt describe the health subject constituted by the marketing campaign for a genetic testing product ( ). interpellation has also been a productive means for scholars to describe how public health officials shape perceptions of risk and responsibility in response to outbreak (briggs ; davis, stephenson, and flowers ) . hand hygiene promotion presents an opportunity to examine the constitutive functions of efforts to foster personal responsibility for infection risk. handwashing campaigns transform perceptions of responsibility for disease outbreaks. they do so by situating the risk of infection in individual bodies. the adoption of illness etiquette in response to hand hygiene promotion thus signals at least a partial acceptance of the new public health. because it singles out the individual bodies-and individual body partsthat spread infection, hand hygiene promotion might be understood as both a constitutive rhetoric and a bstigmatizing rhetoric.^proposed by metzl in against health ( ) and premised on the writings of goffman ([ ] ), a stigmatizing rhetoric derives its conception of the bhealthy^from portrayals of the bunhealthy.^in other words, notions of poor health shore up understandings of good health. as metzl asserts, within a stigmatizing rhetoric, the baffirmation of one's own health depends on the constant recognition, and indeed the creation, of the spoiled health of others^ ( , ) . taking up metzl's refrain, some of the contributors to the multidisciplinary anthology, against health, critique the centrality of stigmatizing rhetoric to a neoliberal model of public health. lebesco, for example, argues that u.s. anti-obesity campaigns reinforce the valuing of bgood citizens [who] take care of their own health^ ( , ) at the expense of those classified as overweight or obese. handwashing campaigns potentially display such a stigmatizing rhetoric whenever their promotion of hand hygiene casts it as a prosocial behavior rather than as merely a method of infection control. according to these stigmatizing texts, the failure to observe hand hygiene has profound consequences in addition to the potential for infection. created by the florida department of health in response to h n , the bfifth guy^campaign illustrates the use of a constitutive, stigmatizing rhetoric to endorse the assumption of personal responsibility for infection risk. i chose this campaign both because of its focus on the workplace and because its messages about risk and responsibility later saw replication in other states (for example, by the michigan department of health). the fifth guy campaign includes an interactive website that hosts a series of public service announcements (psas). together, these psas underscore the need for personal responsibility by dramatizing the tensions that arise when someone in the workplace ignores his duty to limit the spread of infection. underlying the fifth guy, as i argue, is the message that infection risk is exacerbated mainly by the failure to assume personal responsibility. my close reading of the fifth guy also reveals an emphasis on feelings of anxiety, fear, and even self-doubt. as a stigmatizing rhetoric, the fifth guy foregrounds these negative emotions to shore up the value of personal responsibility-in particular, its role in the maintenance of good health. the florida department of health's campaign employs the notion of the bfifth guy^to single out the person who ignores rather than assumes personal responsibility. (my references to the bfifth guy^describe the campaign, whereas discussions of the bfifth guy^refer to its main character.) the campaign has a basis in a study conducted by the american society for microbiology (asm), which found that four out of five people do wash their hands after using the restroom. in this campaign, the fifth guy is not only male but also young, able-bodied, and white. the fifth guy seeks to billustrate a simple point-most people respect certain hygienic norms.^those who do not observe these norms become bthat one person everyone whispers about.^within the campaign's configuration of personal responsibility, displays of illness etiquette are represented as much measures of moral worth as they are forms of infection control. the bfifth guy,^further, is portrayed as at risk of both sickness and social quarantine-exclusion from the group because he poses a threat to public health. to stress the value of personal responsibility, video public service announcements (psas) both televised and posted online exaggerate as deviant the fifth guy's violation ignorance of a workplace's bhygienic norms.^played by comedic actor ben spring, the fifth guy is, not surprisingly, central to the campaign's narrative of personal responsibility. two of the three psas showcase ben's tendency to come to work sick, for him, a point of pride, and for his coworkers, a source of disdain. ben also coughs and sneezes without covering his mouth and nose with his elbow. the videos bcougher^and bsick at home^dedicate considerable footage to shots of ben coughing into his hands, onto food in the lunchroom, during meetings, and in the faces of his fellow coworkers. ben is quite clearly ignorant of his body as potentially-and, in most instances, quite literally-a source of infection risk to the people around him. however, the fifth guy is used to emphasize the necessity of his coworker's efforts to compensate for his ignorance. bhow would i describe ben to you? the next black plague,b en's manager tells the camera in one psa: bthey're gonna say, 'how did it happen, was it rats?' no, it was ben over at amalgamated, responsible for the death of europe.^ben's violations of the dictates of illness etiquette make him an object of disgust within his workplace. more importantly, when illness arises within a workplace, his coworkers come to regard ben's body as its likeliest source. in the fifth guy, attention is paid to ben's body not as a site of sickness-or, put differently, a site of suffering-but as a site of infection risk. this situating of infection risk in individual bodies teaches the importance of avoidance of certain others as potentially (or, in ben's case, it seems, inherently) vectors of infectious disease. ben's coworkers leave the lunchroom when he enters, refuse to shake his hand or give him high fives, and send emails and issue prank calls urging him to go home. in other words, ben is to be avoided because he embodies the risk of infection in public. so, in avoiding ben, his coworkers assume personal responsibility for infection risk. ben's failures in this respect in turn imply that those who succumb to infection have only themselves to blame, perhaps because they, too, ignored the dictates of illness etiquette. avoidance and exclusion, however, are not the only strategies endorsed as both infectioncontrol measures and displays of personal responsibility. in the fifth guy, hand hygiene represents a hedge against infection risk and its absence a violation of the dictum of personal responsibility. bjust another day in the office^illustrates this dual function. in this psa ben's poor hand hygiene habits graphically come to life in the form of a urinal he carries around the office after leaving the restroom. in one scene, ben proudly places his urinal on a coworker's desk while asking for some paperwork. in other scenes, he dances along the office's corridors, embracing his urinal in a mock tango. depicting poor hand hygiene as a urinal makes some sense from the perspective of theories of fomite transmission of infection. these theories explain that, unless properly sanitized, inanimate materials or objects can become contaminated with infectious agents such as influenza virus. similarly, poor hand hygiene-or a lack of hand hygiene-increases the likelihood of the transmission pathogens, both from contaminated surfaces to individuals and between individuals as well. yet, the goal of ben's urinal appears not to be to instruct the workers of florida in the problem of fomite transmission. instead, by emphasizing ignorance of illness etiquette as akin to intentionality, ben's out-ofplace urinal serves as an object lesson in hand hygiene as an expression of personal responsibility. ben is stigmatized-literally marked-to distinguish him from those who observe their obligation to illness etiquette. certainly, the fifth guy teaches hand hygiene as a display of personal responsibility. yet the campaign also reveals another expectation of the new public health, and that is the enforcement of individual behavior change among the non-compliant. frequently lacking the ability to confront him directly, ben's coworkers take advantage of the opportunity to make their concerns known to the camera. byes, i'd say he's a walking pandemic,^the receptionist comments just seconds after ben has left the restroom with his urinal-germs in tow. bquite frankly,^says the coworker whose desk has been sullied by ben's metaphorical urinal hands, bhe scares me.^acknowledging that it can be difficult to reproach our colleagues, bjust another day^ends with the words of a voiceover narrator: bfour out of five people wash their hands in the restroom. could someone talk to the fifth guy?^strategies for doing so appear on the page of the bfifth guy^website on which bjust another day^is posted. tips include emailing your coworker one of the campaign videos with the comment, bhey, sure glad you're nothing like this^or giving him or her ba new nickname like 'big loogie' or 'thunder cough'.^as these rather passive-aggressive strategies suggest, the assumption of personal responsibility for infection risk also involves participation in its enforcement. nevertheless, in using stigma to underscore personal responsibility, the fifth guy potentially both validates anxieties about infection risk and reassures that risk can always be managed. those who regularly encounter infection in the workplace or witness handhygiene violations in public restrooms may feel vindicated by the campaign's mockery of ben, the boffice superspreader.^after all, as the campaign implies, only careless people spread disease. with care, infection can invariably be avoided. the fifth guy's attributions of intentionality may be the campaign's most problematic feature and not simply because such attributions may be likely to exacerbate interpersonal conflicts within public settings. the use of a constitutive, stigmatizing rhetoric has consequences for shared perceptions of infection risk. it is to these perceptions that i now turn my attention. three configurations of infection risk emerge from the fifth guy's encouragement of personal responsibility. first, the most serious risk depicted throughout the campaign is exposure to ben, who is a bwalking pandemic,^possibly even the source of plague. in implying that infection risk is determined mainly by exposure to others, this configuration places undue emphasis on the need for hypervigilance in interpersonal interactions. in ben's story, the assumption of personal responsibility for infection risk takes the form of a kind of citizenepidemiology, with everyone working to root out sources of infection. yet shy of engaging in self-quarantine, most people exercise only limited control over their exposure to others. perhaps in recognition of this fact, the bfifth guy^instructs in subtle pressures that might be applied to those individuals determined to be the potential source of infection-for example, through stigma. second, infection risk is determined largely by one's ability to control and manage certain behaviors. conversely, failure to change habits increases our risk. different scenes from the fifth guy illustrate this formulation of infection risk. motivated by the threat of ben's behavior, his coworkers more than once demonstrate for the camera different practices for limiting infection risk. in displaying their compliance with illness etiquette to the camera rather than to ben, his colleagues indicate the necessity of habitual and bodily responses to the management of infection risk. a third assumption is underscored within the numerous texts that together form the campaign's overarching message about risk and responsibility. in the fifth guy, a lack of knowledge increases one's risk of infection. ben, who displays ignorance of his duty to manage risk, teaches that being knowledgeable reduces the risk of infection (not to mention the threat of expulsion from the group). other elements of the campaign reinforce this equation of knowledge with the assumption of responsibility for infection risk. visitors to the bfifth guy^website can, for example, take a quiz that tests their bhygiene iq.^their scores determine bwhich person^they are in the workplace drama of illness and infection. yet, as anyone who takes the quiz may quickly realize, it is only possible to either be the bfifth guy( ignorant) or not the fifth guy (not ignorant). users who select the incorrect answer to a series of five questions are also goaded to correct their mistakes by the message, bwrong. who are you, the fifth guy?^most of these wrong answers correspond with ben's behaviors in different scenes from the campaign psas. the didacticism of the campaign's testing of hygiene iq raises the question: what knowledge, exactly, do audiences gain through exposure to the bfifth guy^and campaigns like it? perhaps most importantly, the formulation of knowledge as a defense against infection risk teaches an individualistic approach to risk management. within this conception, the complex problem of emerging infectious diseases is most effectively resolved through personal transformations of our daily habits, not to mention of our relationships to one another. in the coming decades, it seems likely that the containment of outbreaks will depend more and more on a program of risk communication that teaches individuals how to protect themselves against infection. within the new public health, this focus on behavioral change is frequently regarded mainly as an alternative to the implementation of costlier, more comprehensive forms of protection, treatment, and care. problematically, however, this encouragement of the personal responsibility for infection risk ignores the influence of contextual and environmental factors. complex economic and social factors, from social support networks to gender, ethnicity, race, and culture, shape and determine the health of populations. instead, even those campaigns that single out the person who (like ben) does not adhere to the dictates of illness etiquette imply equality in our susceptibility to (or risk of) infection. despite its shortcomings, critics have only occasionally spoken out against the emphasis on personal responsibility for infection risk and the neoliberal model of public health it entails. shortly after president obama advised americans to help fend off a global pandemic by washing their hands, for example, cohen wrote a new york times column about the ethical dimensions of the th-day address ( ). was obama's counsel to americans to do their part by washing their hands and staying home from work bmerely good manners,^cohen wondered. or, should his comments instead be understood as a moral injunction, with serious implications for how the nation would cope with the outbreak? put simply, is hand hygiene a matter of etiquette-or is it a matter of ethics? while etiquette may bhave a trivial impact on others,^cohen deemed obama's h n advisory a matter of ethics bbecause it concerns the effect of our actions on other people.Ŵ ashing one's hands removes harmful, disease-causing pathogens, making the endorsement of the act an bethical imperative, meant to mitigate the harm we might do to others.^that hand hygiene has a personal benefit does not make the habit any more ethical-just more desirable, perhaps, because self-care for the most part overlaps with care of others. yet in defending hand hygiene as an ethical imperative, cohen claimed that even this commonsense health habit has its limits. a program of risk management that depends for its success on the assumption of personal responsibility may similarly be too limited an approach to the problem of infection. as cohen put it, the dictates of illness etiquette, although bfundamentally ethical, are not universally applicable.^efforts to mobilize citizens against infection risk require an environment supportive of their participation. adequate supports must exist to ensure that citizens can bdo the right thing.^to illustrate the limits of personal responsibility, cohen discussed the example of labour law: some employees, particularly low-wage workers, risk losing pay or even getting fired if they stay home from work to avoid infecting their coworkers. if we expect individuals to act ethically, we have a societal obligation to protect them when they do-for instance, by guaranteeing paid sick days to all. ( ) during h n , concern about the ability of individuals to behave according to the dictates of public health led to the introduction in the u.s. congress of a bill that would require most employers to provide workers sent home with infections such as influenza a minimum of five paid sick days. paid sick leave, supporters argued, could even be a benefit to the economy, since the policy could both increase productivity and reduce the spread of illness and infection around the workplace. i quote cohen's comments at length because he is one of few critics to publicly speak out about the ethical issues that arise from the increasing encouragement of personal responsibility for infection risk. (even owen [ ] , in describing in detail the brise of purell,^shies away from too staunch a critique of the implications of the turn to hand hygiene promotion.) despite the appeal of the argument that infection risk can be managed mainly through individual behavior change, most exercises in risk management depend for their success on an environment supportive of these changes. in implying that infection risk may be equally distributed across populations, handwashing campaigns exclude the insights of decades of research on the social determinants of health and diseases. in this context, rhetoricians of health and medicine and health humanities scholars contribute meaningful investigations of the rhetoric of personal responsibility and specifically of its emphasis on fear, anxiety, distrust, stigma, and blame. such analyses are sure to deepen conversations among scholars and practitioners about the long-term implications of a seemingly uncontroversial enterprise-the promotion of hand hygiene. as mentioned at this essay's outset, i do not wish to question hand hygiene's efficacy as a form of infection control. myriad studies report on the impact of hand washing on the risk of infection with the majority suggesting that the habit significantly limits the transmission of communicable diseases. to abandon hand hygiene because of concerns about the rhetoric used to promote makes no sense. far from opposing handwashing campaigns, i have illuminated their broader implication in the ongoing individualization and responsibilization of public health, which is also in essence a neoliberalization of public health. hand hygiene promotion, as my analysis suggests, moralizes the spread of infection, making its publics more sensitive to their capacity to sicken, and be sickened, by others. in the context of outbreak, such a perception both potentially lessens expectations of various kinds of support, for example in the form of employment or health benefits. this perception also creates new opportunities for those who stand to profit from the negative emotions often highlighted in messaging about personal responsibility for infection risk. as the target of handwashing discourse, one might thus be wary of the implications of the turn to hand hygiene as a universal antidote to the crisis of emerging infectious diseases. despite its seemingly neutral objective as a form of risk communication, hand hygiene promotion galvanizes a culture of stigma, blame, and distrust in response to the threat of infection. to what extent might these effects in fact inhibit the need for cooperation in the face of a catastrophic outbreak? handwashing campaigns transform perceptions of infection risk, casting illness as a personal failing. this is not to say that infection is not partly a consequence of poor hand hygiene, but the reality is just that. poor hand hygiene is only a contributing factor and not the root cause of the heightened risk of outbreak. it may thus be time to consider alternatives, or complements, to a neoliberal model of public health. personal responsibility has its advantages-that much is clear-but a more expansive approach might better facilitate the cooperation, and compassion, that infectious-disease outbreaks demand. endnotes for the full text of president obama's remarks, see btranscript: president obama's th-day press briefing^( ). see, for example, keränen ( ) ; angeli ( ); ding ( a; b) . keränen also stresses a common interest in the formation of publics, not just through the bofficial texts of biomedicine,^but also through the practices they adopt in response to these texts ( , ). wald ( ) in turn proposes the theory of the boutbreak narrative^to describe the influences of both media and popular culture on responses to infectious disease-in particular, those responses that generate stigma or discrimination. in fact, for a decade prior to sars, purell languished in obscurity (owen , ) . see sadler ( ) , which incorporates critiques of hand-sanitizer use from health historians jacalyn duffin and nancy tomes, both of whom regard the product's popularity as tied to anxieties about infection risk. while worldwide sales figures vary from one source to another, a cnn story reports that shipments of hand sanitizer tripled during h n , from million kilograms to million kilograms (rooney ) . a more recent report (fottrell ) states that u.s. sales of hand sanitizer reached $ million in , and have since averaged nearly $ million per year. plyushteva's ( ) critique of hand hygiene promotion in developing countries documents only the latest stage in a longer arc of handwashing campaigns developed to generate sales for hand soap. vinikas ( ) , for example, chronicles the creation by soapmakers of the s and s of the cleaning institute, which worked to increase soap sales by inculcating schoolchildren into personal hygiene habits. see, also, vinikas ( ) , which illuminates the significance to modern advertising of early-twentieth-century efforts to promote personal hygiene. for the full text of this press release, see royal society for the protection of nature, bglobal handwashing day observed in yoeseltse mss in samtse. the quotations in this paragraph derive from globalhandwashing.org, the website for the global ppphw. for a recent systematic review of the impact of hand hygiene promotion in developing countries, see whom plyushteva quotes, openly criticizes hand hygiene promotion in kerala as a poor substitute for structural interventions, such as the improvement of sanitation systems or provision of clean water another important historical precursor to plyushteva's critique is tomes, which documents the work of latenineteenth and early-twentieth century public health advocates to transform lay understandings of the spread of infection. tomes points out that bentrepreneurs and manufacturers curtis's ( ) review of the emerging body of scholarship on the use of public health discourse to trigger a disgust response in order to motivate individual behavior change my view of health citizenship derives mainly from petersen and lupton ( ), but it also has loose ties to rose and novas' ( ) notion of biological citizenship argues that before the provincial referendum the government of quebec sought support for quebec's separation from canada by constituting the province's inhabitants as ba distinct peuple.^by voting in support of separation a constitutive perspective is also consistent with foucault's theory of subjectivity formation. for a discussion of foucault's significance to health humanities, see petersen which instructs americans to bkeep calm and wash [their] hands,^implying that in washing their hands, citizens consent to their duty to cooperate in the event of an outbreak the fifth guy campaign has also been the subject of social-marketing case studies which is transmitted by fomites. among others, wald ( ) stresses the role of popular culture in circulating certain conceptions of outbreak-views of causality that overstate the role of the individual in triggering an outbreak. similarly, many of the essays in a special issue of american literary history discuss the longstanding influence of popular culture on understandings some of the most frequently-cited references to studies in support of hand hygiene appear on bshow me the science bideology and ideological state apparatuses.^in lenin and philosophy and other essays translated by ben brewster bmetaphors in the rhetoric of pandemic flu: electronic media coverage of h n and swine flu btheorizing modernity conspiratorially: science, scale, and the political economy of public discourse in explanations of a cholera epidemic a rhetoric of motives health promotion materials. the u.s. centers for disease control and prevention bconstitutive rhetoric: the case of the 'peuple québécois bflu fighters.^the new york times bcompliant, complacent, or panicked? investigating the problematisation of the australian general public in pandemic influenza control global handwashing day. deb group ltd bdemarcating medicine's boundaries: constituting and categorizing in the rhetoric of a global epidemic: transcultural communication about sars. carbondale: southern illinois university press drugs for life: how pharmaceutical companies define our health btalk to the fifth guy bhand sanitizer spread faster than the flu.^marketwatch bhygiene and health: systematic review of handwashing practices worldwide and update of health effects bchildren as handwashing agents of change.^the global public-private partnership for handwashing with soap. accessed stigma: notes on the management of a spoiled identity bconcocting viral apocalypse: catastrophic risk and the production of bio(in)security b. b'this weird, incurable disease': competing diagnoses in the rhetoric of morgellons.^in health humanities brisky appeals: recruiting to the environmental breast cancer movement in the age of 'pink fatigue bfat panic and the new morality.^in against health: how health became the new morality bselling certainty: genetic complexity and moral urgency in myriad genetics bintroduction: why against health?^in against health: how health became the new morality bhands across america: the rise of purell the new public health: health and self in the age of risk btalk to the fifth guy: a lesson in social marketing.Ĉ ases in public bthis benevolent hand gives you soap: reflections on global handwashing day from an international development perspective.^journal of health management bpresident obama's th-day press briefing.^ . the new york times. accessed bhand sanitizer in short supply as swine flu hits.^cnn money. accessed bbiological citizenship.^in global assemblages: technology, politics, and ethics as anthropological problems bglobal handwashing day observed in yoeseltse mss in samtse bdo you really need hand sanitizer?^cbc news health and the rhetoric of medicine bpublic health campaign.^in sage encyclopedia of public relations bhandwash or eyewash? selling soap in the name of public private partnerships.^india resource center blife in a time of germaphobia.^the globe and mail the gospel of germs: men, women, and the microbe in american life soft soap, hard sell: american hygiene in an age of advertisement contagious: cultures, carriers, and the outbreak narrative bcurrent who phase of pandemic alert for pandemic (h n ).^the world health organization g l o b a l a l e r t a n d r e s p o n s e ( g a r ) . a c c e s s e d a p r i l key: cord- - amiljnm authors: clements, bruce w.; casani, julie ann p. title: emerging and reemerging infectious disease threats date: - - journal: disasters and public health doi: . /b - - - - . - sha: doc_id: cord_uid: amiljnm this chapter describes the potential public health impact of emerging and reemerging disease. factors contributing to the emergence of diseases include increasing international travel and commerce, changes in human demographics and behavior, advances in technology and industry, microbial adaptation and the breakdown of public health systems. of emerging diseases, % are zoonotic, making the human–animal biome interaction critical. preparedness for an emerging disease relies on strong biosurveillance systems for early detection. control measures to prevent transmission must be implemented early. these include: rapid epidemiologic surveillance and investigations to characterize the disease; transmission prevention through containment and control measures; development and deployment of medical countermeasures; and emergency public information and warning. recovery after the outbreak of an emerging disease can result in a “new normal” with persistent endemic infection in the community. emerging and reemerging infectious disease threats objectives • describe why diseases "emerge" or "reemerge." • discuss the impact of emerging infectious diseases on public health preparedness. • list the likely sources of emerging infectious diseases in the future. • describe how international travel and commerce contribute to emerging infectious disease threats. • discuss how microbial adaptation contributes to emerging infectious disease threats. • list human demographic factors and behaviors contributing to emerging infectious disease threats. • identify the epidemiological clues indicating a possible emerging disease. • describe various types of surveillance approaches. • discuss the breakdown of public health measures and systems. • recognize the actions needed for responding to an emerging disease. on a friday afternoon before the labor day holiday weekend in , the phone at the new york city department of health was answered by the on-call epidemiologist. an infectious disease specialist was calling to report an unusually large number of encephalitis or meningitis cases (inflammation of the brain or covering of the brain and spinal cord) at several hospitals in the borough of queens. blood and spinal fluid were tested at the new york state and cdc laboratories and reported positive for saint louis encephalitis virus (slev), a virus known to occur in the united states but never in new york city. new york city officials immediately began mosquito control programs in an attempt to stop transmission from mosquitoes, the vector for slev. over the next week, test results appeared to be conflicting. unknown to many of the investigators of the human outbreak, a veterinarian at the bronx zoo was investigating an outbreak of central nervous system disease in birds. wildlife veterinarians were also observing large bird die-offs but could not find a clear cause. by mid-september, both sets of investigators believed the causative agent was not slev. by september , after expanding testing services to several federal and academic laboratories as well as to the wider family of flaviviridae, it was confirmed that the causative agent for the human outbreak, the avian outbreak, and sentinel mosquito sampling was west nile virus (see fig. - ). by , the new york city outbreak included confirmed cases and deaths (johnston and conly, ) . by that time, the west nile virus was documented as having spread halfway across the united states to the rocky mountains (roehrig, ) . on april , , a sample was routinely tested from a young girl with influenza-like illness as part of the us sentinel influenza network. the results indicated this was a uniquely novel strain of influenza a (see fig. - ). on april , , a similar result was confirmed miles from the originally identified case. testing also confirmed that this virus was resistant to both amantadine and rimantadine but sensitive to both oseltamivir and zanamivir, two readily available antiviral medications. there had been sporadic cases of influenza with infection of viruses in the swine lineage, and it was suspected and later confirmed that this novel influenza a, h n , was a unique combination of genes most closely related to north american swine-lineage h n and eurasian swine-lineage h n . in the two initial cases, no contact with pigs was discovered through extensive investigation, and it was determined that this novel virus had been spread to these cases by human-to-human transmission, a new behavior for h n . by april , additional cases were identified in texas, and samples collected from an outbreak in mexico were also positive for this new strain. by april , a public health emergency, the first in the history of the united states, was declared to allow for the rapid development of a vaccine, mobilization of antiviral medications through the federally resourced strategic national stockpile, and enhanced surveillance through reporting and testing. travel advisories were put into place, and upon discovery of additional cases internationally, the world health organization (who) raised the pandemic level from phase to the pandemic level phase . the largest number of cases occurred in people between the ages of and years old. major figure - a culex quinquefasciatus mosquito is known as one of the many arthropodal vectors responsible for spreading arboviral encephalitis or west nile virus to human beings through their bite. photo by james gathany courtesy of the centers for disease control and prevention, public health image library. morbidity (illness) and mortality (death) occurred in pregnant women, and middle-aged people with chronic diseases and obesity, but overall the fatality rate was low. few cases were reported in people over the age of , indicating that this group may have had immunity. levels of influenza illness remained high in the summer of , unusual for the north american continent. rapid molecular analysis of the viral genome led to rapid production of a vaccine. in the late summer, the food and drug administration announced the monovalent vaccine would be licensed via a "strain change" pathway, which is similar to how seasonal influenza vaccines are licensed. this meant production would be expedited, since the same methods would be used as those used to produce seasonal flu vaccine and additional safety and validation studies would not need to be completed. by september, , months after the first case was identified, prototype vaccine was delivered to us states for use. h n is now included in seasonal vaccines (gatherer, ). ebola virus disease (evd) was first described in in two simultaneous outbreaks in sub-saharan africa. in december , a small outbreak of evd was reported in a forested area in southeastern guinea (see fig. - ). it has been postulated that the index case, a boy, was in direct contact with bats. this was the th reported ebola outbreak in history but the first to be reported in west africa. evd then spread to liberia and sierra leone, all through direct contact with the outbreak in guinea (who, ) . in guinea, liberia, and sierra leone as of august , , there have been over , cases and , deaths. a small outbreak of cases occurred in nigeria, and one case occurred in senegal. several cases were reported outside of the area, mostly in healthcare or humanitarian workers returning to their home countries. there were also imported cases in the united states and spain which led to secondary infections of medical workers but did not spread further. in both countries, the management of companion animals and environmental cleanup were challenging issues. several factors contributed to the devastation of this epidemic: poverty, population density, infrastructure decline after years of armed conflict, serious gaps in health and medical infrastructure with little to no surge capacity, and a delay in coordinated response. in spite of the significant risk to underresourced healthcare workers (comprising % of the dead), a major humanitarian medical response was launched internationally. in october , controls on people traveling out of the area went into effect with exit screening for symptoms, entry screening in most countries, and active monitoring of travelers in some countries after arrival. this screening program controlled movement and by actively monitoring attempts to identify people who may become ill early in the course of the disease, getting them to healthcare in a controlled manner and with appropriate infection control practices in place. healthcare facilities and providers in many countries stockpiled personal protective equipment, implemented infection control training, and implemented screening processes in order to be prepared. on january , , the who reported for the first time since the week ending june , , that there had been fewer than new confirmed cases reported. the focus of the response shifted from slowing transmission to ending the epidemic. in july , results of early testing of a vaccine appeared very promising. by the end of , the ebola outbreak in west africa reached over , cases and , deaths making it the largest ebola outbreak in history (cdc, ) . prior to this, the largest was a - uganda outbreak with cases and deaths (cdc, ) . at the time this chapter was written, public health professionals around the world continued to watch closely the progression toward stopping, and continued success in recovering from, this devastating ebola epidemic. bacteria plural of bacterium. a single-celled microorganism that can exist independently as a free-living organism or as parasite dependent upon a host organism. emerging infectious diseases illnesses caused by pathogenic organisms with an increasing incidence in humans. infectious diseases with increased incidence over the past two decades or those which threaten to increase in the near future are considered "emerging." emerging infectious diseases include pathogens which are newly evolving, spreading to new geographic areas, are previously unrecognized, or are old infections reemerging due to lapses in public health measures. fungi single-celled or multicellular organisms which cause infections in healthy persons or serve as opportunistic pathogens in persons who are immune compromised. examples include histoplasmosis and aspergillosis. helminths parasitic worms which live in humans or other animals and derive nourishment from their host. examples include the tapeworm, fluke, or nematode. healthcare-associated infection (hai) an adverse localized or systemic infectious condition occurring in a healthcare setting with no evidence that the infection was present at the time of admission. pathogen a biological organism capable of causing disease or illness to its host. prion the smallest infectious particle. it is an infectious strand of protein which replicates and leads to disease, and is similar to a virus. prions are the causative agents of diseases such as mad cow disease and creutzfeldt-jakob disease. protozoa a single-celled parasitic organism that can only multiply inside a host organism. r nought (r ) a metric widely used in assessing disease transmissibility or the basic reproductive rate. it represents the average number of subsequent cases which one case generates during its infectious period. rickettsia a group of microorganisms requiring other living cells for growth like viruses, but having cell walls, using oxygen, and having metabolic enzymes like bacteria. rickettsia are typically transmitted by ticks, mites, or lice. typhus is one example of a disease caused by rickettsia. virus an infectious organism consisting of a nucleic acid molecule in a protein coat. it is only able to multiply inside the living cells of a host. emerging infectious diseases (eids) are some of the most challenging public health issues facing the global community. the hypothesis of "disease emergence" may have helped shaped the growth of global health initiatives, particularly at the world health organization (brown et al., ; lakoff, ) . eids are caused by pathogens that: ( ) have increased in incidence, geographic, or host range; ( ) have changed pathogenesis; ( ) have newly evolved; or ( ) have been discovered or newly recognized (lederberg et al., ) . in most developed countries, routine and seasonal outbreaks challenge health departments and healthcare systems, but reporting, investigation, and treatment protocols are typically in place, trained on, and easily implemented. vaccination programs and antiviral and antimicrobial medications mitigate many recurring infectious disease risks. those who have been exposed to or infected with recurring illnesses have developed some immunity. however, novel infectious diseases pose challenges that often exceed the immune function of populations and the capabilities of public health systems around the world. there are several factors that permit infections previously not seen globally or in specific locations to emerge or reemerge after periods of quiescence. those factors include: international travel and commerce and the movement of goods and people permits the movement of sick people and disease vectors into areas previously not visited, thereby exposing others to pathogens previously not encountered. international tourism has expanded consistently for over years. from to it grew more than ten-fold from million in to million in . it nearly doubled again between to reaching million and again by reaching . billion. annual growth in tourism is expected to grow by over % each year reaching . billion international annual tourist arrivals in (un, ). modern transportation systems allow for rapid movement of people and with them diffusion of illness at a greater speed than during the preavia tion travel era. when travel was slower, often by caravan or ship, those who were ill could recover, layover, or succumb without transporting disease as easily. increased international travel is believed to have played a major role in the spread of hiv/aids. some virologists suspect that hiv was present at very low levels in remote areas of west africa for perhaps as long as years in animals before the disease reached epidemic proportions and was officially isolated by scientists in (krause). hunting animals as a source of protein created greater exposure of humans to the disease, and development of the transcontinental highway from point-noire, zaire (now the democratic republic of congo) to mombasa, kenya, may have allowed truck drivers and traders along this route to carry the virus into the general population. airline travel has its own unique risks, with recirculated air in the confined space of an aircraft which could expose travelers to airborne diseases such as tuberculosis (see fig. - ) . passenger compartment conditions have some similarities to the holds of ships in sea-crossings known historically for harboring eids. with the ease of global travel, people with increased luxury income can visit developing countries, exposing those populations to novel diseases, or return home with novel infections after several hours of airline travel and before signs or symptoms of illness become apparent. economic development may result in changes of land use from agriculture to industry, disrupting established ecosystems. altering natural habitats by building dams and creating deforestation-reforestation programs alters the balance of ecosystems, allowing some species to overflourish or die out. additionally, there may be movement of people into land previously occupied by vegetation and animals, exposing those who resettle to novel or previously contained pathogens and/or vectors. zoonotic diseases, those which infect animals, comprise - % of eids (taylor et al., ) . in the coming plague: newly emerging diseases in a world out of balance, medical journalist laurie garret writes "in this fluid complexity, human beings stomp about with swagger, elbowing their way without concern into one ecosphere after another (garrett, ) ." in addition, the effect of climate change on emerging diseases is unknown; however, lindgren et al. ( ) point out that climate change interacts with "a complex web" of all drivers of emerging diseases and therefore cannot be ignored. alterations of the geographic ranges of birds in europe and north america have also been demonstrated. many migrating birds carry pathogens, and changes to migratory bird habitats may result in human exposures to new pathogens (fuller et al., ) . climate change may also have effects on vector development, vector physiology, and vector habitat, ultimately affecting human vector-borne disease risks (parham et al., ) . human demographic factors and behavior including population density, population growth, and population distribution not only may affect the spread of people into geographic regions not previously inhabited, but it also can expose them to new pathogens. in addition, it may affect how disease transmission occurs from human to human. in many parts of the world, an increase in urban population is not matched by an increase in urban infrastructure and is accompanied by poverty, poor sanitation, and inadequate housing. conflict can result in population shifts to new geographic areas, disruption of critical infrastructure (including public health and health systems), and economic stress. poverty from any cause not only affects sanitation and vector control, but may force people into risk behaviors such as entering the sex trade. once ill, people living in poverty may not have access to healthcare or even have basic hygiene resources. they also may be unable to comply with isolation measures. as populations continue to age and advanced medical interventions such as chemotherapy and immunosuppressive biologicals alter immune function, diseases previously not known to infect humans can emerge. behaviors such as sexual activity and illicit drug use may also impact novel disease transmission. understanding human relationships with animals provides additional insights into eid risks (see fig. - ). sixty percent of recent emerging diseases are zoonotic. colocation of open poultry markets and cohabitation with poultry has been identified as an important risk factor for human cases of avian influenza (dinh et al., ; thorson et al., ; choi et al., ) . human cases of high pathogenic avian influenza have occurred in workers depopulating flocks in the netherlands and canada (koopmans et al., ; tweed et al., ) . fortunately, few of these outbreaks to date have sustained human-to-human transmission. in , an investigation of a large multistate outbreak of monkeypox was traced back to prairie dogs sold as exotic pets. the prairie dogs had been in close contact with giant gambian rats from ghana (cdc, a) . this outbreak resulted in increased controls of imported exotic animals and markets. the source of the severe acute respiratory syndrome (sars) outbreak has never clearly been identified. the index cases were initially linked to catlike exotic pets related to raccoons called "civet cats" (cdc, b) . this resulted in extensive bans on civet cat transportation and commerce. however, detailed investigation links the causative coronavirus to several wild animals used as food, and there are suggestions that the trade of many types of animals used in food was the source (cdc, a,b; he, a,b; normille and enserink, ; guan et al., ; ng, ) . bats play an important role in ecosystems in vector control, seed dispersal, and pollination. however, it is increasingly recognized that bats also play a significant role in the reservoir and transmission of zoonotic infections. contact with bats has long been recognized as a potential source for rabies, but several findings indicate that bats have a wider spectrum of diseases and may be a reservoir for paramyxoviruses such as measles, mumps, distemper, parainfluenza (drexler et al., ; messenger et al., ) , and ebola (leroy et al., ) . freidl et al. ( ) recently discovered antibodies for influenza a h in bats. influenza a h is a zoonotic disease and is a possible candidate for a novel pandemic strain. human interactions with bats and their habitats can occur in the workplace, home or recreational venues. in an observational study in western ghana, nearly half of the residents had contact with bats and bat habitats (anti et al., ) . reengineering and reopening closed facilities where bats have populated must be made with prevention methods in place. entering caves where bats and other animals live must also be approached with infectious disease precautions in mind. technology and industry certainly have tremendous human benefits but may also expose populations to conditions which foster eids. some of the most significant issues are changes in food production. mass agricultural compounds and facilities create environments where changes occur in microbial ecology. globalization of the food supply allows transportation of organisms on and in food and through accompanying vectors. food transportation over large distances may also introduce breaches in food security. advances in medical technology introduce techniques that allow bacteria to infect people and spaces not formerly at risk. increases in invasive procedures can result in the introduction of novel organisms. n n n an epidemiological investigation in traced the source of a mysterious meningitis outbreak to contamination of methylprednisolone acetate, a steroid injected to relieve back pain. several lots of the drug were contaminated with a rare fungus called exserohilum rostratum. over , patients were potentially exposed and had confirmed infections, resulting in deaths across states (smith et al., ) . the cdc healthcare-associated infection (hai) survey of a large sampling of us acute care hospitals found on any given day, about in hospital patients has at least one hai (see table - ). there were an estimated , hais in us acute care hospitals in , and about , patients died during their hospitalizations. more than half of all hais occurred outside of the intensive care unit. contaminated gastrointestinal and bronchoscopy endoscopic devices are among the many advanced technologies associated with increasing outbreaks in healthcare settings, including those of organisms such as pseudomonas aeruginosa and salmonella spp. (kovalevaa et al., ) . the us food and drug administration, whose responsibilities include medical devices, issued a warning in march of raising awareness that several devices with complex designs may be difficult to adequately clean. many causative agents of healthcare associated infections are especially dangerous but their transmission is preventable. while some causative agents are more common bacteria and viruses such as escherichia coli or norovirus, many are less common, including acinetobacter, burkholderia, clostridium, and klebsiella. in addition, antibiotic-resistant strains such as carbapenem-resistant enterobacteriaceae, methicillin-resistant staphylococcus aureus and vancomycin-resistant enterococci and s. aureus are more difficult to control and treat. after the establishment of the european union in the s and increased economic growth, patient transfer within and between countries expanded. after political changes and the opening of borders, medical care and technology improved. for example, the number of bone-marrow transplant units in central europe increased from to by , and the number of dialysis units increased from approximately to more than (krcmery, ) . however, vincent et al. ( ) reported in a one-day prevalence study that % of icu patients in western europe had nosocomial or healthcare-associated infections by microorganisms including p. aeruginosa and methicillin-resistant staphylococcus. microbial adaptation contributes to the development of "super-bugs." this includes both bacteria and viruses (see figs. - and - ). as discussed in the previous section, antimicrobial resistance is pervasive and is increasing in the face of widespread overuse and misuse of antibiotics. in addition, viruses rapidly adapt to immunologic responses. influenza viruses provide an example of genetic drift and shift which make them a persistent health threat. once formed, novel influenza viruses sometimes pose health risks for which humans and/or animals have little to no immunologic protection. these viruses can also develop an increased capacity for animal-to-animal or human-to-human sustained transmission. breakdown in public health systems and measures as a result of conflict, economicbased program cuts, or poor infrastructure can produce environments with increased risk and decreased prevention. this situation may result in disease emergence, but may also to read the full report, please visit the cdc hai prevalence survey (magill et al., ) . result in reemergence of diseases. diseases which had previously been controlled through sanitation, vector control, or vaccination programs can reemerge if any of the prevention programs fail or stop. in developed countries with successful vaccination campaigns, many diseases have been declared "controlled" or "eradicated." because of this, political and public interest in continued vaccination programs is waning, or personal risk is considered low relative to the risk (real or perceived) of vaccinations. in the united states there are also many states allowing "opt-out" programs so people may choose not to get vaccinated or have their children vaccinated. in numerous outbreaks this has proved problematic. n n n the us antivaccination movement has contributed to increased preventable illnesses and deaths. it is led by misguided conspiracy theorists, minor celebrities, and a small number of "healthcare professionals" who are either unfamiliar with or in denial of the science supporting vaccinations. the above headline appeared in january in the new york times (nagourney and goodnough, ) . notable quotes from this report include: • "we can expect to see many more cases of this preventable disease unless people take measures to prevent it," dr. gilberto f. chavez, the deputy director of the california center for infectious diseases, said. "i am asking unvaccinated californians to consider getting vaccinated against measles." • dr. james cherry, a specialist in pediatric infectious diseases at ucla, said the outbreak was " percent connected" to the anti-immunization campaign. "it would not have happened otherwise-it would not have gone anywhere," he said. "there are some pretty dumb people out there." • "the problem is that there are these pockets with low vaccination rates," said dr. jane seward, deputy director of the viral diseases division at the cdc. "if a case comes into a population where a lot of people are unvaccinated, that's where you get the outbreak and where you get the spread." n n n in ghent, belgium, a measles outbreak was associated with an anthroposophic school which promotes "complementary medicine" (braeye et al., ) . over cases of measles were identified in a school that had low vaccination rates because of the philosophical beliefs of the parents. leaders of the school were not against vaccination. striking the balance between individual rights and beliefs, relative risk perception and acceptance, and public health priorities is always challenging. while the next emerging disease can be of any species of infectious organism, trends in recent cases display patterns suggesting which threats may be imminent (see table - ). coronaviruses such as the causative agents of sars and middle east respiratory syndrome co-v (mers co-v); filoviruses such as ebola; and novel influenza viruses, are considered likely candidates. in a study by taylor et al., an analysis of emerging species revealed that of those known, there are currently emerging species. viruses and prions are less than half of the total ( %), and bacteria or rickettsia comprise just under one-third. these potential pathogens may be transmitted by several routes, and the most common route is direct contact ( %), followed by indirect contact ( %), vectors ( %), and for % the route of transmission is unknown (taylor et al., ) . while it may not be possible to predict which pathogens may emerge or reemerge, it is possible to build infrastructure and take general steps to make populations and public health systems better prepared for the next novel infectious disease outbreak. at the heart of these measures is epidemiological surveillance. identification of a new illness or disease requires surveillance systems which not only continually monitor "routine" illness, but also have the ability to recognize anomalies when something is not "routine." as described in chapter "bioterrorism," there have been extensive efforts toward developing early warning epidemiological and environmental surveillance systems for unusual diseases and pathogens. the vital link in identifying a novel disease in a community is the astute clinician. clinicians must be able to recognize a novel disease, report it appropriately, and feel confident that the information will be quickly analyzed and acted upon. laboratory support is vital to quickly identifying and characterizing an emerging threat. this includes testing for drug resistance to inform decision-making concerning appropriate medical countermeasures. continued epidemiological surveillance throughout an outbreak can produce data which may be useful in evaluating and improving the public health and medical response. n n n • surveillance • robust outbreak investigation practices • transmission prevention through containment and control measures • delivery of medical countermeasures, if any • public messaging • recovery to a "new normal" n n n along with surveillance is the ability of public health responders to perform detailed outbreak investigations to determine the characteristics of the disease. characterization of the outbreak, identifying the natural course of the illness, and recognizing key risks for infection are necessary in order to learn how the new illness behaves in a population (see fig. - ) . this information will also inform control measure decisions. a priority item in the initial characterization of an outbreak is the identification of transmissibility. unfortunately, as surveillance methods are enhanced and cases are increasingly recognized and reported, transmissibility may be a very difficult thing to quantify. for example, the current analyses of transmissibility for mers co-v suggest that it is not a likely pandemic threat because of its low reproduction number or "r nought" (r ). however, different cluster sizes, demographics, geographies, and public health and healthcare infrastructures may alter the outbreak characteristics and the reproduction number (r ) (fisman et al., ) . capturing critical data will allow for accurate characterization within the context of the outbreak and will direct response activities such as control measures and medical surge management. the primary control strategy in all infectious disease outbreaks is preventing transmission. even minimal biosecurity actions can prevent animal-to-human transmission. separation of potential source animals, such as exotic imported animals and poultry, from routines such as cooking can reduce risk. effective cleaning of animal waste and habitats should be performed with at least basic respiratory protection. to prevent human-to-human transmission, good hygiene practices such as hand washing, general surface cleaning, and careful waste disposal should be reinforced. during the - h n pandemic, people were advised to "cough hygienically" into their sleeve to prevent contamination of the hands and then others. of note, this technique was not without some controversy and was not recommended in the united kingdom and spain (anderson, ) . supplying hand wipes and hand sanitizer may be implemented in some locations of businesses, critical industries, and government agencies where other measures may not be reasonable. social distancing by school closures, limiting mass gatherings, and canceling large events may be necessary (see figs. - and - ). quarantine may be considered for individuals who have been exposed but are not yet sick, typically for two incubation periods of the disease. isolation separates those who are already ill from those who are not ill. in healthcare settings, isolation may begin from early screening of patients at points of entry. this may limit disease transmission to other patients who often have underlying conditions which increase their risks for severe illnesses and complications. risk management for communicable diseases in emergency departments includes signage to encourage patients to self-identify if they are sick or have an associated travel history. this allows for rapid triage to isolation areas and early institution of personal protective equipment for staff (puro et al., ) . in a study conducted of facilities in european countries, % had isolation rooms, but not all had anterooms, negative pressure, or hepa filtration. only . % had all components. personnel trained in the recognition of highly infectious diseases were available in of the , and management protocols were available in of the (fusco et al., ) . it would be interesting to see how attention paid to diseases such as ebola has impacted these numbers. in addition to human-to-human spread, animal-to-human spread is a common transmission route for eids. zoonotic disease professionals can develop recommendations for vector control when zoonotic diseases threaten human populations. mosquitoes are the most pervasive disease-carrying vectors. control measures include reducing standing water breeding sources or using larvicides and adulticides. the recent introduction of engineered aedes aegypti mosquitoes (ox a), which can reproduce and produce offspring which die rapidly, shows promise in areas with emerging dengue fever (specter, ) . once control measures are determined, public health agencies must have the legal and social authority to implement recommended measures. the majority of the population typically complies with basic containment measures such as improved hygiene, avoiding ill people, etc. however, some individuals may be reluctant or unable to comply. for example, minimally ill people without paid sick leave may not be able to stay at home without significant economic loss. people may, out of fear, choose to flee quarantine zones. in these cases, agencies need to have flexible, scalable authorities to limit travel outside areas known to have disease. the challenges with quarantine measures were apparent throughout the international response to the - west african ebola epidemic. in the united states as in many countries, the government has the authority to restrict stateto-state and international travel. state and local health agencies have authority to control intrastate activities. however, political pressure may make it difficult to enact some control measures. school closure is one of the more difficult decisions for government agencies during a public health emergency. for many communicable diseases, children can act as superspreaders because of their behaviors and hygiene lapses. however, many schools function not only as places of education but also deliver significant social programs: safe havens, meals, and day care for working parents with marginal income. to close these schools disrupts very necessary social welfare programs. quarantine laws must also respect civil liberties. in the united states for example, quarantine orders must be the least restrictive form of control, have very clear reasons, be timelimited and allow for appeal. enforcement of quarantine orders requires law enforcement officers to interact, sometimes in close physical proximity, with potentially contagious individuals. additionally, any enforcement of quarantine of an individual must be heard in the judicial system. the judiciary has its own constitutional constraints of process which are frequently in opposition to the goals of quarantine. if the eid is susceptible to antibiotics or a vaccine is quickly developed, rapid distribution and dispensing of these medical countermeasures must be conducted. if the illness is highly contagious, programs limiting public interaction during mass dispensing and mass vaccinations will need to be implemented. as discussed throughout this text, it is unlikely that there will be large quantities of medical countermeasures available early on in an emerging or reemerging infectious disease outbreak. therefore, plans must also be in place for the utilization of scarce resources while complying with ethical and legal frameworks. throughout the entire outbreak, appropriate public messaging must be delivered. messages will contain information about the illness, personal protective actions, and where to go for health care. these messages must communicate risk and how individuals can limit morbidity and mortality. general prescripted public health messages can often be adapted early in an outbreak when detailed information on the threat is not yet specific. trusted leaders in the community should be used to deliver messages in order to improve compliance and alleviate fear. a "new normal" may follow as a community recovers from a novel outbreak. some eids become endemic diseases in affected communities and must be included in recurring public health activities. for example, west nile virus was first introduced to the western hemisphere in the late s and is now an annual threat, causing , cases from to and deaths (cdc, ) . however, public health responses help to establish new practices in order to limit reemergence. these activities also prepare the community for similar eid threats. because of ongoing west nile virus threats in north america, the region is better prepared for emerging threats such as chikungunya and dengue. public health has been challenged with eids throughout human history. with globalization of populations, commerce, and travel comes globalization of infectious diseases. this exposes people and animals to novel diseases for which they have little to no natural immunity. rapid transportation and free movement allows sick individuals to spread illness and disease faster than ever before. preparedness efforts cannot predict the next emerging infection, but public health and healthcare capabilities developed, lessons learned from prior outbreaks, and institutionalization of routine infection control practices may serve to lessen the impact. european centre for disease prevention and control 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contaminated methylprednisolone injections the mosquito solution risk factors for human disease emergence. philos is exposure to sick or dead poultry associated with flulike illness? a population-based study from a rural area in vietnam with outbreaks of highly pathogenic avian influenza human illness from avian influenza h n , british columbia world tourism organization. unwto tourism highlights the prevalence of nosocomial infection in intensive care units in europe: results of the european prevalence of infection in intensive care (epic) study ebola response team . ebola virus disease in west africathe first months of the epidemic and forward projections west nile virus fact sheet key: cord- - kpw ru authors: guo, jing; feng, xing lin; wang, xiao hua; van ijzendoorn, marinus h. title: coping with covid- : exposure to covid- and negative impact on livelihood predict elevated mental health problems in chinese adults date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: kpw ru the covid- pandemic might lead to more mental health problems. however, few studies have examined sleep problems, depression, and posttraumatic symptoms among the general adult population during the covid- outbreak, and little is known about coping behaviors. this survey was conducted online in china from february st to february th, . quota sampling was used to recruit chinese citizens aged ≥ years old. mental health problems were assessed with the post-traumatic stress disorders (ptsd) checklist for the diagnostic and statistical manual of mental disorders, fifth edition (dsm- ), the center for epidemiological studies depression inventory, and the pittsburgh sleep quality index. exposure to covid- was measured with questions about residence at outbreak, personal exposure, media exposure, and impact on livelihood. general coping style was measured by the brief coping style questionnaire (scsq). respondents were also asked additional questions about covid- specific coping behaviors. direct exposure to covid- instead of the specific location of (temporary) residence within or outside the epicenter (wuhan) of the pandemic seems important (standardized beta: . , % confidence interval (ci): . – . ). less mental health problems were also associated with less intense exposure through the media (standardized beta: − . , % ci: − . –− . ). perceived negative impact of the pandemic on livelihood showed a large effect size in predicting mental health problems (standardized beta: . , % ci: . – . ). more use of cognitive and prosocial coping behaviors were associated with less mental health problems (standardized beta: − . , % ci: − . –− . ). our study suggests that the mental health consequences of the lockdown impact on livelihood should not be underestimated. building on cognitive coping behaviors reappraisal or cognitive behavioral treatments may be most promising. the covid- pandemic not only affects physical health, it might also lead to elevated levels of mental health problems such as sleep problems, depressive issues, and posttraumatic stress symptoms [ , ] . the pandemic is, however, a multifaceted and complex type of exposure. living in the epicenter of the outbreak or having travelled to that center might make a difference in the way the the survey was conducted online from - february , and the questionnaires were distributed and retrieved through a web-based platform (https://www.wjx.cn/app/survey.aspx). quota sampling was used to recruit participants. chinese citizens aged ≥ years old were invited to participate. in total, participants from provinces in china responded to the survey; students were excluded because of their special status, which resulted in a final n = adults. to reach more subjects with high exposure to covid- and from somewhat lower social economic strata, we targeted recruitment to six groups that might otherwise have remained underrepresented, namely medical workers, service staff, social service workers, (school and college) teachers, blue-collar workers and farmers, and unemployed individuals and others. the convenience sampling was conducted as followed. first, several key contact persons in these specific groups were selected, for example a chief nurse, class tutor, or company manager. second, the key contact persons helped us distribute the questionnaires to the subjects through their wechat group (a very popular chinese online communication tool). third, the subjects in each wechat group were asked to send our questionnaire web link to their friends. this way data were collected from medical workers (n = , . %), service staff (n = , . %), social service workers (n = , . %), (school and college) teachers (n = , . %), blue-collar workers and farmers (n = , . %), unemployed individuals and others (n = , . %). almost % of the respondents were male, and . % of the subjects were between - years old. more than half of the sample completed at least undergraduate studies, and more than % were married. the large majority had a middle to high income and % worked in the formal labor market. there were some differences between the participants within wuhan, in sub-wuhan, and outside wuhan (for details, see table ). all participants gave consent after being informed about the aim of the survey and joined the study voluntarily. the study was approved by the ethics committee of peking university medical center. depressive symptoms were assessed with the -item center for epidemiological studies depression scale (cesd), which has been widely used to measure depression in the general population [ ] . previous studies demonstrated that this scale has adequate reliability and validity among chinese respondents [ , ] . respondents reported the frequency of each type of symptom on a -point scale: (rarely or never; less than day), (some of the time; - days), (a moderate amount of the time; - days), or (most or all of the time; - days). the total score ranges from to , with a higher score indicating a higher level of depressive symptoms. in this study the cronbach's alpha was . . with a cut-off point at [ ] , respondents were divided into two categories, "depressed" or "not depressed". post-traumatic stress symptoms (ptss) ptss were assessed with the self-report post-traumatic stress symptoms disorders (ptsd ) checklist for the diagnostic and statistical manual of mental disorders, fifth edition (dsm- ), estimating the degree to which individuals had been struggling with dsm- -related ptss symptoms in the past month [ ] . respondents answered the items on a -point rating scale from (not at all) to (extremely). items were summed for a total score ranging from to , with higher scores indicating higher level of ptss. cronbach's alpha was . . the items were clustered in the following areas: intrusions, avoidance, negative alterations in mood and cognitions, and alterations in reactivity and arousal. the diagnostic criteria of dsm- require at least one "intrusion" symptom, one "avoidance" symptom, two "negative alterations in mood and cognitions" symptoms and two "alterations in reactivity and arousal" symptoms, all rated or higher. sleep problems were assessed using the pittsburgh sleep quality index (psqi) [ ] . the psqi consists of items rated from to including estimation of sleep latency, duration, disturbances, and the severity and frequency of other sleep problems. the total psqi score ranges from to with higher scores indicating worse sleep quality. cronbach's alpha was . . with a cut-off point at [ ] , respondents were divided into two categories, struggling with "insomnia" or "no insomnia". because of the high correlations between the scales for depression, ptss, and insomnia, ranging from r = . - . , we decided to compute a principal component analysis. a strong first component emerged, with loadings > . . the aggregated scale for mental health problems was the sum of scales for ptss, depressive symptoms, and sleep problems. the question about wuhan exposure concerned living in or having travelled to wuhan, with " " referring to living in or having had a wuhan travel history, or " " referring to no wuhan residence or travel history. also, two questions were asked about living near wuhan city, and not living in the vicinity of wuhan city, with yes or no as possible answers. exposure to the covid- pandemic through watching or using the media was answered on a -point rating scale for frequency: very frequent, often, some, no exposure). direct exposure to covid- was assessed with a question about possibly having suffered or suffering from covid- , or someone in the family, or neighborhood or among friends, with " " for covid- of self, a member of the family, a friend, someone in the neighborhood, and " " referring to no exposure). the respondents were asked to estimate the impact of the pandemic on their livelihood, with four response alternatives (none, some, relatively large, very large impact). it was measured by the simplified coping style questionnaire (scsq), developed in china [ ] . the scsq is a self-report scale which comprises of items with a -point rating scale, ranging from (not used) to (used a great deal). the scsq consists of two subscales: problem-focused coping and emotion-focused coping. the problem-focused coping category includes twelve items that describe positive cognitive and behavioral strategies to manage distress. the emotion-focused coping category includes eight items that describe negative cognitions and avoiding behavioral activities to manage the problem. this inventory has good internal and test-retest reliability. in the present study, cronbach's alpha of the total scale was . and that for problem-focused coping and emotion-focused coping were . and . , respectively. respondents were asked how they were coping with covid- . the questions concerned specific coping behaviors, including "tell myself that everything will be better soon", "reading and watching tv", "getting more knowledge about covid- ", "wearing a mask when going outside", "staying home and following the social distancing rule", "disinfecting and deep cleaning", "crying, being angry, and yelling", "drinking", "smoking", "praying", "taking more medicine", and "taking one's temperature". the respondents were asked to rate the behaviors from (not used) to (used a great deal). the following covariates were measured. demographic variables included ethnicity (han, else), marriage (having no spouse, having a spouse), education (junior high school and below, high school/technical school, junior college, undergraduate, postgraduate and above), and income (low, middle, or high income). job descriptions included the seven categories mentioned above and categorized into jobs in the formal versus informal sector. following previous studies [ , ] , health-related variables included questions pertaining to prior mental health problems (yes, no), and occurrence of two-week illnesses (yes, no), and prior exposure to potential trauma (experience of a traumatic event in the last year (yes, no)). the main analyses consisted of multiple regressions on the aggregate outcome of mental health problems in four steps, and in each step the same covariates were used: age, gender, educational level, formal or informal job, married, income, past illness, prior exposure, prior mental health problems. in model each of the predictors were included separately to estimate their 'raw' contribution to the prediction of mental health problems, controlling for the covariates. in model the three predictors of (potential) exposure (location, media, direct exposure) were included to examine which component would be the most powerful predictor. in model the perceived impact on livelihood was added, and finally, in model emotion-focused and problem-focused coping behaviors were included to explore how much variance coping would predict in mental health problems. the standardized beta's can be compared across models and predictors, lower and upper % confidence intervals (cis) were computed as well as the p-values. in the next series of logistic regression analyses, the odds and their % ci and p-values for the predictors of the three components of mental health problems were computed, again with the same four models. the components ptss, depression, and insomnia were dichotomized to differentiate between clinical and nonclinical cases. in a final set of analyses regressions with the coping behaviors as predictors of mental health problems were conducted, controlling for the same set of covariates used in the previous regressions. the software for statistics and data science (stata) version . (statacorp., college station, tx, usa) was used to carry out all analyses. in table the results of the multiple regressions on the aggregate outcome of mental health problems are presented. the largest variance in mental health problems was explained by coping behaviors, with more use of problem-focused coping behaviors predicting less problems (effect size beta = − . ), and more use of emotion-focused coping behaviors predicting more problems (effect size beta = . ). furthermore, an important predictor was the perceived impact on livelihood. larger impacts were associated with more mental health problems and the standardized beta for the respondents feeling the largest impact amounted to a standardized beta of . . finally, direct or indirect exposure to covid- through location, media, or infected cases predicted statistically significant variance in mental health problems, with wuhan location, very frequent media exposure, and actual direct exposure to the virus predicting elevated levels of mental health problems. standardized beta's ranged from . to . (positive or negative), thus considerably smaller effect sizes compared to those found for impact on livelihood or coping. a sensitivity analysis was conducted including formal versus informal job as a predictor of mental health problems instead of its role as a covariate but the beta in model was a negligible . ( % ci: − . - . ). for predicting ptss the models showed that exposure through location, media, or direct contact was less important than the impact on livelihood and coping behaviors. more impact on livelihood and more emotion-focused coping were associated with higher risk of clinical ptss levels, whereas problem-focused coping reduced this risk (see table ). this was similar for the prediction of risk for depression, but living in the neighborhood of wuhan instead of within the city of wuhan lowered the risk for depression (odds = . ), whereas direct exposure added predictive value by elevating the risk of becoming clinically depressed (odds = . , see table ). direct exposure also was associated with elevated risk of insomnia (odds = . , see table ). the models with more predictors included in the same regressions did not make much of a difference compared to model with only one predictor at a time included (and the covariates of course). only in model in which coping was included in the last step the negative beta for living in the neighborhood of wuhan but not in wuhan itself was not statistically significant anymore (beta = − . ). very frequent media exposure and direct exposure to covid- kept predicting elevated levels of mental health problems. the large effect sizes for impact on livelihood and coping attenuated only slightly from model to model , and they were still substantial, in particular problem-focused and emotion-focused coping style. in figure the practical coping behaviors are presented. more emotion-focused coping behaviors such as "crying, being angry, and yelling", "drinking", or "smoking" seemed to be associated with largest risk for mental health problems but more frequently "praying", "taking more medicine", or "taking one's temperature" also elevated this risk albeit to a somewhat lesser extent. most helpful in decreasing the risk for mental health problems were coping behaviors such as "telling myself that everything will be better soon", "getting more knowledge about covid- ", and "staying home and following the social distancing rule". to a somewhat lesser extent it seemed also to help when coping with "reading and watching tv", "wearing a mask when going outside", and "disinfecting and deep cleaning" were used (see figure a) . a similar picture emerged or the association between coping behaviors and ptss, depression, and insomnia separately (see figure b- figure . the relationship between coping behavior and post-traumatic stress symptoms (ptss), depression, insomnia, mental health problems. (a) coping and ptss, (b) coping and depression, (c) coping and insomnia, and (d) coping and mental health score. notes: v refers to "tell myself that everything will be better soon", v refers to "reading and watching tv", v refers to "getting more knowledge about covid- ", v refers to "wearing a mask when going outside", v refers to "staying home and following the social distancing rule", v refers to "disinfecting and deep cleaning", v refers to "crying, being angry, and yelling", v refers to "drinking", v refers to "smoking", v refers to "praying", v refers to "taking more medicine", and v refers to "taking one's temperature". these items were asked in a random order in the questionnaire. all confounding variables were controlled in above models. or, odds ratio. ci confidence interval. coping and depression, (c) coping and insomnia, and (d) coping and mental health score. notes: v refers to "tell myself that everything will be better soon", v refers to "reading and watching tv", v refers to "getting more knowledge about covid- ", v refers to "wearing a mask when going outside", v refers to "staying home and following the social distancing rule", v refers to "disinfecting and deep cleaning", v refers to "crying, being angry, and yelling", v refers to "drinking", v refers to "smoking", v refers to "praying", v refers to "taking more medicine", and v refers to "taking one's temperature". these items were asked in a random order in the questionnaire. all confounding variables were controlled in above models. or, odds ratio. ci confidence interval. our main findings point at the significant role of direct exposure to covid- instead of the specific location of (temporary) residence within or outside the epicenter of the pandemic. increased mental health problems were also associated with more intense exposure through the media. most importantly, in our relatively highly educated and predominantly lower to upper 'middle-class' participants the perceived negative impact on livelihood showed the largest effect size in predicting the level of mental health problems. we also examined the effect of coping style and coping behaviors against covid- and found that a problem-focused coping style and positive cognitions and prosocial coping behaviors predicted reduced mental health problems. compared to wuhan, we found a lower mental health level among sub-wuhan participants. however, this difference disappeared after adjusting for coping. previous studies on earthquake survivors and on / world trade center survivors showed that participants who were living closer to the epicenter showed increased mental health issues [ , ] . our study provides somewhat contrasting evidence for the covid- affected population. direct exposure, perceived impact on livelihood, and how one was coping with the pandemic seemed more important than the specific location of (temporary) residence within or outside the epicenter (wuhan) of the pandemic. for specific mental health problems some different associations were found. direct exposure to covid- elevated the risk for depression and insomnia but not for clinical ptss, for which the perceived impact on livelihood seemed more important. impact on livelihood was also associated with depression but not with insomnia. direct exposure to covid- involves higher risks for infection and severe respiratory illness, leading to more mental disorders [ ] , but it is unclear why only the risks of clinical depression and insomnia but not ptss appeared to be elevated. for ptss the threat of poverty and the deterioration of economic conditions due to the outbreak seem more important. this threat to livelihood reduces social resources such as access to medical care, education, employment, and well-being for the individual and his or her family, which may cause even greater harm to mental health than the epidemic itself [ ] . our findings demonstrate that coping styles are associated with mental health problems due to covid- . a problem-focused coping style seems to relieve individuals' post-traumatic stress, depression, and insomnia symptoms, and the emotion-focused coping style seems to exacerbate mental health symptoms [ ] . problem-focused coping is a positive strategy that entails some active methods such as finding out several different ways to solve the problem or seeking advices from relatives or friends. emotion-focused coping tends to emphasize passivity and powerlessness, which enhances anxious and depressed feelings. in line with positive effects of problem-focused coping, we found that practical behaviors such as emphasizing positive cognitions [ ] and getting more information about the virus indeed were associated with less mental health problems. in a previous study, positive cognitions about the severe acute respiratory syndrome (sars) outbreak were shown to result in less psychological disorders [ ] . it also seemed to help when participants tried to cope by following the (pro-)social distancing and hygienic rules. a recent study indicated that personal psychoneuroimmunity prevention measures such as the frequent practice of hand hygiene and wearing face masks could decrease the likelihood that individuals would experience psychiatric symptoms [ ] . through knowledge acquisition and hygienic behaviors individuals actively try to alleviate their fear of uncertainty about the future. some implications may follow from these findings. first and foremost, the mental health consequences of the expectation of a large negative impact on livelihood should not be underestimated. regardless of location or exposure the economic threats of the pandemic seem to leave a rather strong imprint on mental health. as a worldwide recession has been predicted to follow the current pandemic [ ] , our findings foreshadow indeed 'a crashing wave' not only of immune-system related neuropsychiatric disorders [ ] , but also of a wide array of stress-related depressive symptomatology without a direct link to deficits of the immune system. the most effective coping behaviors are pointing at cognition and might suggest the potentially promising role of reappraisal interventions [ ] or cognitive behavioral treatments [ ] in fighting the negative mental health consequences of the pandemic. also, the positive role of following the rules of social distancing and hygiene may suggest the importance of active, prosocial involvement in the containment or slowing down of the virus infection also for coping with the mental burden of the pandemic. it may induce a collective feeling of empowerment and some control over an otherwise overwhelmingly stressful experience [ ] . some limitations of this study should be mentioned. first, although it is tempting to interpret our findings causally it should be noted that the cross-sectional design without experimental manipulation does not allow for causal conclusions. it is difficult, however, to see how exposure to covid- might be the effect instead of the cause of elevated mental health problems, controlling for pre-existing problems. nevertheless, the associations with perceived impact on livelihood and with coping behaviors might be (partly) caused by elevated mental health problems, and longitudinal or quasi-experimental studies may throw some light on the causal direction [ ] . second, because we used an internet survey in a large sample it was not possible to include a long series of scales, questions, and items. we relied for example on a simple but clear-cut question about the respondents' feelings about the impact of the pandemic on their livelihood and we want to emphasize the need for further research on this issue with more elaborated measures. our findings certainly demonstrate that this is a fruitful path to follow in the near future. third, generalizability of the results might be restricted in time, geography and sociocultural context. our data were collected at the beginning of february , a moment in time where the true nature of the pandemic seemed not yet clear to the general public worldwide or even to the experts. furthermore, the study was conducted in various parts of china but surely did not have worldwide coverage and thus its findings might be (partly) specific to this geographic environment. lastly, we recruited a chinese convenience sample for which the nonresponse rate could not be established because of anonymity requirements and in which poor participants from rural areas without internet connections were underrepresented. this underrepresentation of poor participants might have led to an underestimate of the mental health consequences of worries about livelihood issues during and after the lockdown. the covid- outbreak in wuhan was followed by a worldwide pandemic and unprecedented lockdown of many large cities and entire countries. here we reported on the early mental health sequelae (in the first few weeks of february ) of the outbreak in the 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goldstein, neal d.; suder, joanna s. title: application of state law in the public health emergency response to covid- : an example from delaware in the united states date: - - journal: j public health policy doi: . /s - - - sha: doc_id: cord_uid: znh pja the unprecedented covid- pandemic of – generated an equally unprecedented response from government institutions to control contagion. these legal responses included shelter in place orders, closure of non-essential businesses, limiting public gatherings, and mandatory mask wearing, among others. the state of delaware in the united states experienced an outbreak later than most states but a particularly intense one that required a rapid and effective public health response. we describe the ways that delaware responded through the interplay of public health, law, and government action, contrasting the state to others. we discuss how evolution of this state’s public heath legal response to the pandemic can inform future disease outbreak policies. and the president declared a national emergency march [ ] . authorities typically make these declarations to allow for allocation of emergency funding and to simplify processes that would burden a public health response in time of emergency. the policy intent behind these declarations is not to close borders, restrict due process, or broadly revoke civil liberties. even "shelter in place" orders-first enacted at a state level in the u.s. by california on march [ ] then quickly followed by other states-ensured that residents would maintain access to essential goods and services, and could leave their homes to gather goods or use services. restricting movement in congregant settings can spread disease, as observed aboard cruise ships [ ] , and potentially violate fundamental humans right such as the freedom of movement [ ] . we focus on delaware during the pandemic of winter and spring for several reasons. compared to other states, delaware experienced a rapid increase in the number of cases over a short period of time, necessitating a quick and robust public health response to control the outbreak. as of june , delaware reported , cases of laboratory-confirmed covid- ( cases per , people) since diagnosis of the first case on march [ ] , a likely underestimation [ ] . compared to other state rates at that time, delaware placed in the top % ( th overall) for known cases per capita; for mortality, delaware ranked th with deaths per , people [ ] . these comparatively high per capita rates occurred despite delaware being tied for th place among states to report a confirmed case and the last state in the mid-atlantic region of the u.s. (which includes the nearby major metropolitan areas of washington, d.c., philadelphia, and new york city) [ ] . on march , delaware's governor declared a state of emergency as a means to coordinate state agency responses to the outbreak. the governor called on the delaware national guard to assist, advised against public gatherings in excess of people, and prohibited excessive price increase of goods or services [ ] . since then, delaware modified the terms of the state of emergency twenty three times through june to close public schools, prohibit in-person dining at restaurants, close select non-essential businesses and public beaches, require wearing of face masks, require health screening for anyone entering a high-risk essential business, and limit public gatherings in excess of people, among other actions [ ] . on march , the state also declared a public health emergency to bring in out-of-state and activate 'inactive' health care providers (often those who had retired) and loosen requirements to permit new sites for delivery of health care [ ] . another reason to examine delaware is the nature of its population, which includes many of the covid- risk groups seen across the u.s. the state has densely populated urban areas, rural farmland with migrant worker populations, and a seasonal tourism industry with popular beach resorts. delaware's poultry processing plants in two southern counties became sources of several outbreaks, an industry particularly hard hit across the u.s. these plants made sussex county, delaware a 'hotspot' [ ] . also, delaware has an older population vulnerable to covid- , many in long-term care facilities. historic precedent for emergency legal responses to disease outbreaks predates covid- [ ] . coordination between public health and law typically occurs through state agencies requesting legal advice from state legal authorities-for general guidance about the scope of legal authority and responses to questions. engagement with the law may also occur proactively and from the outset, if authorities foresee potential need for legal orders, such as quarantine, isolation, government closures of schools and businesses, seizure of property, or any combination. as covid- progressed from mainland china, throughout asia, europe, and north america, the world health organization (who) and cdc assured the world learned of the spreading epidemic before confirmation of the first case in delaware. these communications alerted public health and legal authorities to many potential legal implications of responding to covid- in advance. delaware's early legal response included updating and sharing draft orders among key state agencies, laying the groundwork for subsequent action. thus, delaware officials, and their legal counsel, acted quickly to review the extent of government emergency powers and how best to use them in response to a pandemic. the division of public health is the sole public health agency in delaware with statewide jurisdiction. this can be contrasted with majority of other states that have both state and local jurisdictions or district offices (only the state of rhode island is similar to delaware in this regard). the benefit of this structure was ensuring consistency and efficiency of the pandemic response. for example, public health measures such as masking mandates might be discrepant between jurisdictions leading to confusion among citizens. delaware largely avoided such confusion [ ] [ ] [ ] [ ] . a single statewide agency, however, has the burden of coordinating and implementing the public health response for the entire state, including guidance, testing, and provision of supplies. the transition of the world health organization (who) from identifying covid- as multiple local epidemics to a pandemic on march [ ] may not have directly impacted responses in the u.s. however, this shift in awareness as to the widespread severity of covid- coincided with many local declarations of emergencies in the u.s. the declarations of 'public health' and 'national emergencies' released federal funding to agencies responding to the outbreak. in the u.s., it is not the federal government but the states that hold primary responsibility for managing disease outbreaks and any federal funding directed to states. technical assistance from the cdc also played an important role. delaware declared its own state of emergency [ ] concurrent with declarations of the national emergencies and who's pandemic designation. from a practical perspective, delaware's declaration achieved several goals: • it enabled the state's department of health and social services and the state's department of safety and homeland security to procure goods and services more readily, such as testing supplies and personal protective equipment. • it suspended the requirement to conduct government public meetings in person, as large group gatherings may lead to viral transmission. • it activated a coordinated emergency response. contrasted with a state-level 'public health emergency', a 'state of emergency' is broader. even so, a state public health emergency, declared on march [ ] , enabled additional measures beyond the scope of the initial state of emergency. the transition also brought about a change in the goals of public health. early in the outbreak, delaware focused on surveillance and planning. as the outbreak widened and became more difficult to contain, the state shifted focus to harm reduction through social distancing. this was evident in several modifications to the state of emergency [ ] , to limit socialization and crowding, and, subsequently, an order to 'shelter in place' (see discussion). this type of response does not occur spontaneously or in a vacuum. previous outbreaks and emergencies served as models for covid- across the nation [ ] . delaware's division of public health adopted and adapted surveillance systems used during the h n influenza pandemic of and the ebola outbreak in in order to monitor covid- . there were also similarities in the covid- outbreak with the state's opioid epidemic and this experience informed the state's response. delaware again quickly initiated mitigation and harm reduction to prevent morbidity and mortality from covid- . legal procedures for response to a reported case of active tuberculosis provided a model for quarantine and isolation orders. and weather-related emergencies (such as blizzards) served as models for the shelter in place order. a shelter in place order to contain a disease outbreak, however, was unprecedented. the classic example of a state's police power to protect the health of a population is use of 'isolation' and 'quarantine' for active tuberculosis. the state employs isolation when an individual exhibits symptoms, or is clinically diagnosed with, a contagious disease that may threaten others. delaware's administrative code (regulations) defines isolation as, "the physical separation and confinement of an individual or group of individuals who are infected or reasonably believed to be infected with a contagious or possibly contagious disease from non-isolated individuals to prevent or limit the transmission of the disease" [ ] . states may impose quarantine when a person has a known exposure but has not (yet) demonstrated clinical illness. delaware's administrative code defines quarantine as, "the physical separation and confinement of an individual or group of individuals who are or may have been exposed to a contagious or possibly contagious disease but who do not yet show signs or symptoms of the contagious disease from non-quarantined individuals to prevent or limit the transmission of the disease" [ ] . states impose either or both orders to prevent spread of disease to susceptible populations who are not infected nor immune to the disease. delaware may invoke isolation and quarantine in several ways. outside of an emergency declaration, the division of public health may initiate an emergency isolation or quarantine procedure if a medical provider determines a person to be an imminent threat to others. the division may also petition the courts for a quarantine or isolation order even without 'imminence'. delaware's state of emergency declaration reinforced the existing statutory authority for the division of public health or the delaware emergency management agency to isolate or quarantine an individual on an emergency basis or following a court hearing. the process for either isolation or quarantine is complex. many parties may participate, including those in public health, health care, the judiciary, and law enforcement (fig. ) . isolation and quarantine orders are usually imposed as measures of last resort. that is, before the state limits an individual's civil liberties, it must demonstrate that the order is the least restrictive means possible and does not infringe upon an individual's liberties more than absolutely necessary. in delaware, from the start of the outbreak through june , all individuals isolated and quarantined voluntarily. had any persons failed to comply with voluntary isolation or quarantine, the state would have sought a court order requiring isolation or quarantine; failure to comply with the court order could result in action by law enforcement. on march delaware enacted a statewide shelter in place (also known as a stay-at-home) order-one of the first states to do so [ ] . as of june , other states had enacted statewide orders (excluding arkansas, iowa, nebraska, north and south dakota, oklahoma, and utah) [ ] . fig. flow chart depicting the general procedures for quarantine and isolation widely in duration (as short as days in mississippi; as long as days in new jersey). some orders did not reach across the entire state but directed restrictions to specific high-risk groups or locales (as in oklahoma, south dakota, and iowa). delaware's order expired on june (in effect for days, th longest state in the country), and had not been reactivated by june . shelter in place orders require citizens to stay in their homes or places of residence unless they need to go out for specific goods or services-for food and groceries, health care, utilities and infrastructure, and government services (see ref. [ ] for a full listing of what is 'essential' in delaware [ ] ). individuals may leave their residences for other prosaic reasons, to exercise, walk pets, and commute to jobs considered 'essential'. exempted from delaware's order were individuals experiencing homelessness, or who felt unsafe in their homes (for example, due to domestic violence) although authorities requested all people to maintain social distancing. a shelter in place order approaches the constitutional limits of government-sanctioned control of an outbreak, but authorities can employ other disease mitigation measures during an outbreak. examples include driving restrictions and requiring individuals to be tested for infection. delaware used neither as of june in response to covid- . (delaware implemented an oral screening questionnaire for any person entering a high-risk business, such as a healthcare or institutional setting [ ] .) public health has broad statutory authority in the time of an outbreak, especially when confronted with a novel contagious disease such as covid- . even so citizens maintain certain rights under the state and federal constitutions. government may not act arbitrarily or capriciously, nor can governments discriminate against any class of people protected by the state or national constitutions (for example, on the basis of race). in delaware, citizens have the right to information on government actions during and after the covid- outbreak; they collect the information by making a request under the freedom of information act [ ] . in cases of orders to isolate or quarantine, individuals have the right to an attorney, a hearing, and to bring forth witnesses or evidence. they may also appeal an order or request a modification to their order (see fig. ). reflection on the delaware response yields several useful lessons. first, legal responses to the pandemic should involve the entire government, and not rely upon a single branch. delaware relied exclusively on orders from the executive branch (the governor) to direct the state's response rather than joint executive and legislative action because the legislature did not hold sessions during the pandemic to avoid adding to disease transmission [ ] . other state legislatures similarly postponed sessions and some employed remote sessions or strict social distancing measures; delaware reconvened virtually on may [ , ] . although executive orders proved effective in delaware, their use may be problematic because state constitutions and laws often limit executive authority in time and scope. legislatures can craft long-term solutions to problems that arise during a pandemic, such as immunity for medical providers (from legal action by patients or their families who believe they have been harmed) or reimbursement for telemedicine visits. second, policy responses to the outbreak must reflect the population's needs, especially locally. while statewide shelter in place and social distancing orders are effective for people who have the ability to adhere to them, for others this was not possible. in sussex county, delaware, multiple outbreaks of covid- occurred among workers in the poultry industry, many of whom resided in group homes or larger family settings [ ] . delaware's large migrant worker population may be similarly affected as farms hire seasonal workers who have no place to shelter away from others. thus, policymakers need to tailor responses to reflect these real-world variations. finally, states and localities should establish a core team or point person to manage inter-agency communication. successful pandemic response depends on cooperation between public health, emergency management, fiscal, and executive leadership. legal guidance should be fully enmeshed in decision making to ensure agency goals can be executed quickly and without major repercussions. application of state law in the time of public health emergencies has historic precedent in the united states and will continue to evolve as does covid- . early measures taken by other locales, as examples of effective action, aided delaware's early response. so too did guidance from the who and the cdc. post-outbreak, time to reflect upon decisions made will clarify what enabled or impinged upon the state's response and its responsibility to keep its citizens healthy and free from disease. further, the legislative process can be used to revise law that impeded response. future research could usefully examine whether policies implemented by the state at a given point in the pandemic were supported by scientific evidence of prevention of covid- at that time. this exercise could inform responses to subsequent public health emergencies. conflict of interest on behalf of all authors, the corresponding author states that there is no conflict of interest. covid- ) cases in u association of state and territorial health officials. coronavirus disease (covid- ) response hub determination that a public health emergency exists remarks by president trump, vice president pence, and members of the coronavirus task force in press conference state of california executive department public health responses to covid- outbreaks on cruise ships -worldwide universal declaration of human rights delaware division of public health. coronavirus disease (covid- towards reduction in bias in epidemic curves due to outcome misclassification through bayesian analysis of time-series of laboratory test results: case study of covid- in alberta, canada and philadelphia, usa. bmc medical research methodology latest map and case count covid- data repository declaration of a state of emergency for the state of delaware due to a public health threat public health state of emergency declarations declaration of a public health emergency for the state of delaware governor carney declares covid- hot spot in sussex county, announces expansion of community testing sites us emergency legal responses to novel coronavirus: balancing public health and civil liberties central florida counties, cities with mask mandates more indiana cities mandate masks as virus infections grow nearly texas counties have opted out of gov. greg abbott's mask order. others refuse to enforce it the missouri times. where are masks required in missouri? world health organization. who director-general's opening remarks at the media briefing on covid- - the new york times. see how all states are reopening (and closing again delaware division of public health essential services screening recommendations for covid- pandemic delaware freedom of information act. del. code legislative session postponed until further notice due to coronavirus pandemic about -state -legis latur es/coron aviru s-and-state -legis latur es-in-the-news national conference on state legislatures. legislative sessions and the coronavirus chicken plants-and the food supply-take center stage in delaware's covid- fight key: cord- - jjg qw authors: kiendrébéogo, joël arthur; de allegri, manuela; meessen, bruno title: policy learning and universal health coverage in low- and middle-income countries date: - - journal: health res policy syst doi: . /s - - -z sha: doc_id: cord_uid: jjg qw learning is increasingly seen as an essential component to spur progress towards universal health coverage (uhc) in low- and middle-income countries (lmics). however, learning remains an elusive concept, with different understandings and uses that vary from one person or organisation to another. specifically, it appears that ‘learning for uhc’ is dominated by the teacher mode — notably scientists and experts as ‘teachers’ conveying to local decision/policy-makers as ‘learners’ what to do. this article shows that, to meet countries’ needs, it is important to acknowledge that uhc learning situations are not restricted to the most visible epistemic learning approach practiced today. this article draws on an analytical framework proposed by dunlop and radaelli, whereby they identified four learning modes that can emerge according to the specific characteristics of the policy process: epistemic learning, learning in the shadow of hierarchy, learning through bargaining and reflexive learning. these learning modes look relevant to help widen the learning prospects that lmics need to advance their uhc agenda. actually, they open up new perspectives in a research field that, until now, has appeared scattered and relatively blurry. advancing universal health coverage (uhc) to improve population health is a long-term objective that many low-and middle-income countries (lmics) have committed to. since the release of the world health report , entitled 'health systems financing: the path to universal coverage' [ ] the flagship document that popularised the conceptextensive research and initiatives have focused on the subject matter at national and international level. such research and initiatives have helped to map the many challenges, identify best approaches to spur countries' progression [ , ] ; assess progress made by countries and build databases describing the situation prevailing in countries [ ] . yet, in many countries, challenges remain. research findings are not always properly integrated into policy and practice [ ] . above all, uhc is a complex endeavour at the crossroads of technique and politics, applied to health systems that are themselves complex and, thus, to some extent unpredictable [ , ] . for instance, a policy that has succeeded in one place may fail in another [ ] or the results of a policy designed and implemented in a country may be quite the opposite of what was expected [ ] . therein, it has been argued that the ability to continually learn and adapt is essentiallearning should then be at the heart of uhc-related policy processes [ ] [ ] [ ] . indeed, there is growing interest among global health actors towards 'learning for uhc'. some of them even have an explicit learning-oriented mandate in their support to countries such as the 'joint learning network for uhc', 'p h network', 'uhc partnership' and 'uhc ′. yet, there is not much scientific literature on learning processes related to uhc [ ] and questions abound, some highlighted in table . these questions, to a large extent, remain either not answered or only partially answered, probably because learning, itself, is an elusive conceptit is framed, defined, understood and used differently from one person or organisation to another [ ] . this article is not intended to provide a specific answer to each of these questions but to enrich our knowledge and understanding of what 'learning for uhc' could entail. it is worth mentioning that, if the attention to learning is relatively new in health policy, the concept has a long tradition in academia and has been extensively studied in other disciplines such as psychology, education, international relations, sociology, organisational studies and political science [ ] . learning can be approached through different theoretical and pragmatic perspectives, the most prominent ones including cognitivism, behaviourism and constructivism [ ] , or even social constructionism if we add a social dimension [ ] . from the cognitive stance, learning is related to the acquisition of new insights, assumptions, understandings and awareness resulting in new mental models or belief systems [ ] . the behavioural stance, meanwhile, insists on the need that such cognitive changes be followed, simultaneously or after, by 'shifts in actions or behaviours'the so-called 'cognitive-behavioural perspective' [ ] . changes in actions or behaviours in turn influence the cognitive aspects of learning in a kind of iterative loop [ ] , as observed in the 'action learning', 'after action review', 'action research' and 'learning-by-doing' approaches. as for the social constructionism stance, learning emerges from social interactions and realities through formal and informal networks such as communities of practice defined as "groups of people who share a concern, set of problems, or a passion about a topic, and who deepen their knowledge and expertise in this area by interacting on an ongoing basis" ( [ ] , p. ); for instance, when young practitioners learn by interacting with experienced medical staff in a hospital [ ] . this paper adopts and adapts the definition of learning put forward by two political scientists, dunlop and radaelli [ ] learning is the updating of knowledge, beliefs and actions based on lived or witnessed experiences, analysis or social interaction. beyond its synthetic nature, this definition meets our special interest for public policies, specifically uhc-related policy processes. the political science literature provides us with the concept of 'policy learning', which is learning applied to policy-making processes. it "occurs through the very practice of policy-making" ( [ ] , p. ). moyson and scholten define it as "the cognitive and social dynamic leading policy actors to revise or strengthen their policy beliefs and preferences over time" ([ ] , p. ). policy learning can manifest itself in a variety of ways, notably "as updates to our understanding of instrumental or technical aspects of a policy problem, as changes to our underlying policy beliefs or values about societal priorities in responding to problems, and as fundamental alterations to the institutions that target these problems" [ ] and also as adoption of new and innovative ideas. in the next sections of this paper, we first give a (nonexhaustive) overview of the literature on learning and how we came up to adopt the analytical framework by dunlop and radaelli [ ] . thereafter, we critically reflect on how this framework could help lmics widen the learning prospects they need to advance their uhc agenda. actually, without claiming to be exhaustive, we find this framework relevant to account for and capture a multitude of learning situations encountered empirically during uhc processes. these learning situations (or learning modes) could serve as reference points for national and international actors engaged in promoting learning for uhc to gain more insights on what they are doing and to help them make deep analyses and critical reflections on their actions in order to improve them. navigating the literature on policy learning is a daunting task since the latter is 'characterised by concept stretching' [ , , ] and resembles a maze where the risk of straying is ever present. this is exemplified by a recent bibliometric study conducted by goyal and howlett [ ] , which identified publications on the topic from to , and other literature reviews performed by leading scientists in the field [ , , ] . actually, the taxonomy of learning is rich, depending for instance on the content, direction and framing of learning [ ] or the methods and tools used. hence, learning types are diverse and not necessarily mutually exclusive, including, among table examples of relevant questions related to 'learning for uhc' • how does 'learning for uhc' occur at country level? • what type(s) of learning predominate or are favoured at country level and why? • what is the role of learning in policy-making processes? • what dynamics (actors and factors) facilitate or hinder learning processes at country level? specifically, how does context, including organisations' features and dynamics, shape learning and affect learning outcomes? • how and by whom are countries' learning needs identified? are they properly identified? • what actions are being taken to address these needs? are they successful? others, instrumental learning, social learning, political learning (may [ ] , hall [ ] ), policy-oriented learning (sabatier [ ] ), government learning (etheredge and short [ ] ) and organisational learning (argyris and schön [ ] ). besides, other concepts are closely linked to learning such as those of policy transfer (dolowitz and marsh [ ] ), policy diffusion (shipan and volden [ ] , marsh and sharman [ ] ), policy convergence (bennett [ ] , holzinger and knill [ ] ) and lesson drawing (rose [ ] ). in general, policy learning is studied in relation to policy change and fits best into the large group of cognitive approaches to public policy analysis, a school of thought that emphasises the role of ideas, beliefs, values and norms in public policy [ ] . actually, before heclo ( ) [ ] , the hitherto dominant paradigm was that only conflicts and power relations convincingly explain changes in public policy. heclo [ ] and followers of his school of thought challenge such prospect and emphasise the crucial role of ideas and learning. indeed, heclo argues that "politics finds its sources not only in power, but also in uncertaintymen collectively wondering what to do" ( [ ] , p. ); learning is thus seen as an answer to "the problem of managing and reducing radical uncertainty" ( [ ] , p. ) in policy-making. then, policy learning somehow opens perspectives in the analysis and understanding of complex interactions between knowledge, policy and power [ ] . moreover, it has been postulated that learning does not only generate positive effects and could have its setbacks. indeed, learning is not risk-free if one does not rely on the right actors, if its content is poorly understood and/or if its goals are diverted. for instance, it may happen that one is "persevering in listening to the wrong teachers", "implementing the wrong lesson" or "applying the right lesson to the wrong institutional context" ( [ ] , p. ), especially if there are no self-critical processes and/or iterative learning loops. furthermore, if learning purposes are ill-defined or poorly specified, it can be manipulated and used to legitimise choices already made and/or serve private or hidden interests [ ] . finally, as usual in any policy process [ ] , learning and its effects on subsequent policies can have political, economic or social implications, with vested interests of major players at stake. it is therefore important to analyse and consider the political economy surrounding learning endeavours [ , ] . by delving into the political science literature on learning, a book chapter has particularly attracted our interest since it was helpful in navigating the vast literature on 'policy learning'. this chapter concerns the allegorical description by dunlop et al. [ ] in the form of a family tree, of the evolution of the concept from the founding fathers (notably john dewey, harold lasswell, karl deutsch, charles lindblom, herbert simon and hugh heclo) to the most recent developments. dunlop et al. [ ] distinguish three main periods: the late s to the s (corresponding to the roots of 'policy learning'), the s to the s (assimilated to the trunk of the tree) and s to the present (representing the branches of the tree). they assert that recent work is "less concerned with the type of learning per se (instrumental, political, social …) and more focused on the characteristics of the policy process that determine varieties or modes of learning" ( [ ] , p. ). for example, the policy process can hold epistemic, hierarchical, bargaining-oriented or reflexive trait [ ] . this strong connection between learning features and policy process features resonated with recent work that dunlop and radaelli have pioneered, sparking our interest in the analytical framework they proposed [ ] . dunlop and radaelli [ ] use the 'concept formation' approach proposed by sartori [ ] and the 'exploratory typologies' technique described by elman [ ] to make the concept of policy learning more tangible. for that, they identify, from the literature, two main dimensions that matter in the social and learning mechanisms of policy processes. the first one is 'problem tractability', which relates to the level of uncertainty regarding the policy issue under discussion, the degree of solvency of the problems subject to learning [ ] -"a repertoire of solutions, algorithms, or ways of doing things" exists ( [ ] , p. ). low tractability is equivalent to high uncertainty and vice versa. when tractability is high, the transferability and diffusion of lessons learned and solutions from one setting to another is easier, and vice versa. the second one is 'actors' certification', that refers to "the authority and legitimacy of some key actors or venues" ( [ ] , p. )certified actors have a privileged position to influence decision/policy-making and the higher their level of certification, the higher this privilege. drawing on adult education science, dunlop and radaelli [ ] metaphorically assimilate 'learners' to decision/policy-makers or policy implementers and 'teachers' to knowledge holders or producers (e.g. experts, scientists, interest groups, think tanks) striving to influence decision/policy-making or institutional rules. in this perspective, low actors' certification equates to a low divide between the learner and the teacherthere is no knowledge hierarchy. by crossing these two dimensions, 'problem tractability' and 'actors' certification', dunlop and radaelli [ ] end up with a four-quadrants matrix and subsequently classify the vast literature on policy learning according to these four quadrants. in doing so, they identify four learning modesepistemic, reflexive, bargaining and hierarchical learningsdepending on the level of uncertainty or actors' certification vis-à-vis the policy issue ( fig. ) . we postulate that these four learning modes could help better understand the scope and variety of configurations that 'learning for uhc' can take. epistemic learning and learning in the shadow of hierarchy, typically, are vertical and prescriptive ways of learning. in epistemic learning, you have ( ) someone who 'knows' and someone who is likely to learn, ( ) intractable policy issues looking for technocratic answers. 'expert power' [ ] is actually used to look for solutions to well-identified problems. experts and scientists are at the heart of the policy process and enlighten policymaking through their authoritative knowledge. as for learning in the shadow of hierarchy, it piggybacks on the exercise of authority, such as a principal who creates some pressure on an agent to learn [ ] , for example, because of frequent supervisions. such learning may be used to achieve specific or predefined goals or results. if epistemic learning and learning in the shadow of hierarchy are two vertical learning modes, reflexive learning and learning through bargaining are rather horizontalthere is no pecking order in knowledge. reflexive learning entails open, deep, inclusive and critical discussions without (self) censorship between policy actors to gain mutual meaningful insights on issues at stake. learning through bargaining, meanwhile, implies repeated social interactions and "is often the unintended product of dense systems of interaction between politicians and bureaucrats" ( [ ] , p. ). dunlop and radaelli's approach to policy learning modes enriches the field of public policy analysis by highlighting the role of learning in policy-making and decision-making spaces, both conceptually and empirically. this is relevant from the uhc perspective regarding the critical role that learning could play in uhc processes, especially with the complexity of health systems [ , ] . our hypothesis is that dunlop and radaelli's work offers an opportunity to pursue a reflection in this direction, starting with the learning modes they propose. in the next sections, we offer some personal reflections on how these learning modes already contribute and could probably be even more applied to uhc in lmics. due to our professional history, we are probably privier or more acquainted to epistemic forms of learning through our own engagement in epistemic communities. however, where appropriate, we strived to ignore this posture and took the critical distance needed to explore/illustrate the other forms or modes of learning occurring in uhc processes. when relevant, we also highlight how learning intertwines with power relationships. epistemic learning is probably the most visible, analysed and rationalised mode of learning today in global health [ ] . this is probably also true for the uhc agenda, something which might be explained by its strong technical dimension and health financing lineage [ , ] . when we are facing a question, we look for an expert or an actor able to implement a rigorous approach to remove the uncertainty. it is so prevailing that it is actually our main understanding or expectation of how learning should take placethis seems particularly true within a scientific community so committed to research and the prospect of evidence-informed policy. epistemic learning takes several configurations in our 'collective action for uhc' in lmics. epistemic learning encompasses situations such as ( ) reading a policy-brief or even a scientific article, particularly a systematic review or a metaanalysis; ( ) attending national, regional or international meetings or training workshops; ( ) the release of conceptual or analytical frameworks to better understand the concept of uhc or its linkages with health system pillarsexamples include the health financing functions [ , ] or the 'uhc cube' [ ] ; or ( ) specialist agencies or researchers sharing lessons learned in other countries [ , ] or developing policy guidance notes on how to move quickly towards uhc [ ] [ ] [ ] . epistemic learning can also take a more active form, for instance, as technical assistance to countries in various possible arrangements -'fly-in/fly-out' or longterm technical assistance [ ] , with local and/or international experts who are embedded or not in government institutions, and acting as individuals or as part of national, bi-multilateral or international bodies. in any case, their mandate would be to assist countries implementing complex reforms or still struggling to find the 'right' policies tailored to their context and/or the proper way to design and implement them, including institutional arrangements and policy instruments [ ] . examples include how to improve healthcare services utilisation and quality, how to improve public financial management or how to make health care services purchasing more strategic. decision/policy-makers are thus expected to rely on the knowledge of scientists and experts, sometimes in the form of a coaching or mentoring approach [ ] to find solutions to these intractable issues. ideally, these scientists and experts should be people familiar with the technical and non-technical (e.g. political, social, cultural, economic) intricacies of the context a condition not always fulfilled [ , ] . they would then have both legitimate, expert and informational power [ ] to advise countries or technical departments of ministries in charge of uhc on how to successfully implement specific policies or processes, taking into account path-dependency and other local specificities [ ] . however, sometimes, even deep contextual knowledge, mobilised for instance through reliance on national experts, is not a guarantee of success. uhc policy processes are complex with many unknowns. for instance, we still do not know much on how to sequence steps towards uhc [ ] . it may happen that, because of haste or oversimplification, experts do not see the limits of their toolbox, including analytical frameworks or generic political guidance developed by international agencies. this is particularly problematic if critical thinking is poorly developed among decision/policy-makers. scientists and experts can also be seen just as useful contributors to policy processes. this situation is encountered in some middle-income countries [ ] ; an issue then is that experts may be used instrumentally to justify certain choices. scientists and experts may also be facing governments that know very well where they want to go but are in great need of advice on which path to take and are looking for experts willing to support them. in these situations, scientists and experts could be used as 'facilitators' since processes are country led. examples include rwanda or ethiopia, which show strong leadership in their uhc policy choices and bring external partners to follow the path set by the government [ , ] . the challenge for scientists and experts here is not to lose their independence vis-à-vis the government or the politicians and, sometimes, to push for more reflexivity. lastly, one can imagine a ministry or an actor that has some resources and capacities but appreciates external guidance on what to do and achieve. scientists and experts could thus play the role of 'producers of standards', with the big challenge to produce high quality standards tailored to country needsthis is not obvious if the scientists or experts lack in-depth contextual knowledge. however, this could also include the use of normative frameworks produced by individual scientists or experts, or international agencies [ ] [ ] [ ] . it seems to us that the international uhc community has so far paid little attention to this second mode of learning. in reality, it is taking place but it is not highlighted in the literature nor made explicit. in the context of uhc, a typical example of reflective learning could be the learning that emerges from what is coined "démocratie sanitaire" [health democracy] in the francophone systemthat is, a process promoting citizen participation in health policies development and implementation through consultation, public debates and dialogue [ ] . actually, community actors are directly involved in policy processes and learning is collective, arising through the co-production of ideas and discussions. another example of reflexive learning is deliberative processes bringing together various stakeholders to collectively reflect on complex issues to get better insights and suggest possible solutions [ , ] . there are flat power relations between policy actors and no knowledge hierarchyall types of knowledge are equally esteemed. here, we can draw a parallel with the facilitation techniques using the rules of brainstormingall the participants are equal, no idea is stupid and everyone participates. in the face of uncertainty, in a context of reforms, or in a situation where certain values and social norms must be questioned and new perspectives adopted, these open approaches based on dialogue, discussion, exchange of information and ideas are welcome rather than being an issue [ ] . indeed, they allow to gain mutual meaningful insights on issues at stake and there is room for serendipity as well as bold and innovative ideas. concretely, this learning mode seems little used in countries where decision-making is highly centralised. indeed, reflexive learning in some way would constitute a kind of 'endangerment' as it involves losing some control over the policy process. the national health assemblies in thailand, originating from the concept of the 'triangle that moves the mountain' [ ] (described below), which started in the early s, and the societal dialogue for health system reform, launched in tunisia in [ ] , are typical examples of situations where reflexive learning could occur. the societal dialogue in tunisia aims to develop a health system more responsive to citizens' expectations with a new mode of governance based on decentralisation and 'health democracy' [ ] . however, as in any process where decisions have to be taken by many at the same time, this dialogue turned out to be quite complex [ ] . learning through bargaining is probably the most overlooked mode of learning in the health policy literature. yet, we think that it happens daily, as policymakers constantly learn from their interaction with stakeholders. such learning arises when there are exogenous or endogenous attempts to shift policy objectives or instruments. learning will emerge from efforts done to reach an agreement. examples include ( ) the adoption (or not) of output-based financing mechanisms [ ] ; ( ) the degree of autonomy to be granted to health facilities in terms of organisation, service delivery and use of resources [ ] ; ( ) how health insurance funds should be collected [ ] , pooled, allocated and the benefit package designed [ ] ; ( ) changes in the market structure of healthcare provision, including the promotion (or not) of the private sectorthe so-called public-private partnerships [ ] ; and ( ) more generally, the adoption of some reforms, laws and regulations in the health sector [ ] . learning through bargaining is also a distinctive feature of certain permanent mechanisms such as priority-setting and budgetary negotiations [ ] , discussions between donors and their countries counterpart to set up health policies [ ] or, as part of the global fund, proposal developments for funding applications or principal recipients nominations by the country coordinating mechanisms [ ] . another example of learning through bargaining is the 'triangle that moves the mountain', a nice metaphor showing how sound interactions between key stakeholders in thailand, namely researchers producing policy-relevant knowledge, civil society organisations and communities leading a social movement, and politicians providing required resources, have been able to promote social learning and yield major changes in a difficult context [ ] . learning through bargaining focuses on the preferences of stakeholders [ ] and stems from a dialectical process. government officials negotiating with each other (e.g. ministry of health with other ministries such as social welfare or finance) and with external partners, civil society or unions to find out how to develop a coherent uhc policy are learning a lot. for instance, in morocco, such learning occurred when several ministries with divergent views gathered around the same table to discuss ramed (régime d'assistance médicale; a health coverage scheme for the poor) options, each bringing their own knowledge and experience [ ] . bargaining is essential as uhc policies may not be consensual and require trade-offs or choices that are eminently political, often involving resources redistribution and disruption of power relations. there seems to be little guidance today on how to institutionalise this learning mode; knowledge mainly remains tacit, as 'experience' and can 'evaporate' quite quickly [ , ] . in the context of uhc, learning in the shadow of hierarchy emerges from the very exercise of public authority. it is therefore practiced by all health authorities, although in varying ways and quality. hierarchical learning is particularly cherished by disease programmes and international agencies with an operational mandate such as unicef. indeed, like epistemic learning, hierarchical learning is directed and prescriptive. it corresponds to the situation where an actor uses his/her/its 'legitimate', 'coercive' or 'reward power' [ ] to purposively orient policy actions in a desired direction in order to enforce a policy or achieve specific goals or results. let us mention that some people in a high hierarchical position can also be scientists or experts (e.g. scientists or experts being decision-makers or politicians)we propose to consider these situations as learning in hierarchy instead of learning in epistemic contexts. in any case, the quality of learning will depend on the compliance of the governed, the clarity on the roles of stakeholders and the effectiveness of instructions. such learning, for example, is supported by field supervision visits, good monitoring and evaluation systems with adequate metrics to analyse policy actors' performance, or annual policy reviews. it thus values deliverables and measurable results. generally, knowledge is acquired both by the person holding authority who provides supervision or performs the monitoring and by the 'street-level bureaucrats' who make the effort to understand the instructions. learning can be enhanced if the supervisor is able to take advantage of the lay knowledge of the grassroots actors and not necessarily believe that his/her own hierarchical position or seniority means superior knowledge. in fact, hierarchical learning can be supported through the proper use of internal routine data. this is probably one of the great learning opportunities that remains minimally exploited for uhc [ ] . furthermore, like learning through bargaining, knowledge gained during the monitoring remains very tacit (embodied knowledge) and can get lost if, for example, a group of people is not stabilised at the head of uhc policy processes or if health workers are regularly deployed to other positions. several important points emerge from our research. it has shown that there are many ways to learn, materialised by the learning modes proposed by dunlop and radaelli. in-depth analyses of what mode(s) of learning is occurring, with whom, when, where, why, how, at what level and with what results, in relation to specific uhc processes in lmics, deserve being empirically investigated and, we trust, will be the subject of future research. further research exploring their triggers, constraints and pathologies [ ] would also be relevant. for instance, as hindrances, tacit knowledge gained during learning can get lost if people are not stabilised at their positions or if the turnover is too high. consequently, health authorities would lose learnings accumulated. learning for uhc naturally occurs. however, learning can also be organised or directed. among 'uhc promoters', there seems to have been so far an operational bias towards epistemic learning, often under a teacherlearner model. it is undeniable that this learning mode demonstrates some effectiveness to tackle technical knowledge and capacity gaps in many lmics, but this bias possibly stems also from power structures or unchallenged assumptions (e.g. donors knowing more than governments; academia knowing more than practitioners). in any case, there are probably missed opportunitiescountries do not leverage the large array of learning situations that have great potential to spur their progress toward uhc. today, too few ministries or technical departments are purposely investing in their own systemic learning capacities [ ] [ ] [ ] . beyond the illustrations we provided in this paper, applied work is needed to know more about what learning modes occur, when, where, how, at what level and under what circumstances. for instance, akhnif et al. [ ] already observed, in their case study on ramed, that "learning changes in nature across the different stages of the policy process"our study allows to deepen this subject matter by highlighting a grid to better categorise and analyse these different moments of learning. it would also be compelling to investigate what learning modes are mobilised or emerge at each stage of the strategic planning process, as proposed by who [ ] . furthermore, digitisation has created great potential for learning, both at the decision-making level and at the operational level, but this remains largely untapped [ ] and further research is needed to unravel ways to better exploit this potential. other studies could also explore the contribution of different hybrid models, that is, varying degrees of mixtures of different learning modes. indeed, learning modes are not mutually exclusive; they co-exist, occurring sometimes at the same time. a good example of a hybrid model is the 'coaching and mentoring' support provided by the strategic purchasing africa resource centre (sparc) to an expert panel of kenya's national hospital insurance fund to comfort it as a strategic purchaser of health services [ ] . this experience was rich in reflexive (through the engagement of various stakeholders), bargaining (to accommodate divergent opinions and reach consensus through formal and informal discussion channels) and epistemic (the mentor giving expert advice only when requested) learnings. learning generated through pilot schemes, as was the case for performance-based financing with rwanda [ ] , health equity funds in cambodia [ ] , the ramed in morocco [ ] , or user fees removal policies in burkina faso [ ] , is also an interesting case. policy actors and experts knew what they were looking for but they also acknowledged that there were many unknowns. by combining their assets (public authority, ideas and experimental methods), they together constituted an original body of knowledge that could be used to inform decision-making and scale-up processes [ ] . in the cases reported above, policy actors' learning seemed to have combined at least the epistemic and reflexive modes, both enhanced by experimental action, as promoted by garvin [ ] . similar hybrid learning is probably in application with the practice of study tours: there is an epistemic component (learning from another country with a more 'advanced' experience) and a reflexive component (since visitors, and possibly guests, informed by their own observations collectively reflect), before any experimentation or application back home. this paper aimed at illustrating the possibility and relevance of using the concept of 'policy learning' to analyse learning in uhc processes in lmics. dunlop and radaelli's framework allowed us to throw a new light on existing processes but also to widen the learning prospects that countries could tap into to advance their uhc agenda. the new perspectives highlighted in this article also 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the case of a ugandan hospital development cooperation as learning in progress: dealing with the urge for the fast and easy the global fund: managing great expectations triangle that moves the mountain and health systems reform movement in thailand the place of learning in a universal health coverage health policy process: the case of the ramed policy in morocco routine health facility and community information systems: creating an information use culture pathologies of policy learning: what are they and how do they contribute to policy failure? world health organization. strategizing national health in the st century: a handbook barriers and facilitators to health information exchange in low-and middle-income country settings: a systematic review advice from a mentor: legitimacy, flexibility & credibility from scheme to system (part ): findings from ten countries on the policy evolution of results-based financing in health systems translating knowledge into policy and action to promote health equity: the health equity fund policy process in cambodia how burkina faso used evidence in deciding to launch its policy of free healthcare for children under five and women in ownership of health financing policies in lowincome countries: a journey with more than one pathway learning in action: a guide to putting the learning organization to work publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors would like to thank wim van damme and maxime k. drabo for inputs they provided in this study. they also thank four anonymous peer reviewers who provided insightful comments that helped improve the paper. authors' contributions jak and bm performed study conceptualisation. jak made an extensive literature review and wrote the first draft of the study. bm and mda revised it thoroughly and mda provided further inputs into the study conceptualisation. jak drafted the final version that was revised by bm and mda. all authors read and approved the final manuscript. this article is part of jak phd thesis work. jak benefits from a grant for this thesis, funded by the belgian development cooperation.availability of data and materials not applicable.ethics approval and consent to participate not applicable. not applicable. the authors declare that they have no competing interests. key: cord- -hpbh o authors: humboldt-dachroeden, sarah; rubin, olivier; frid-nielsen, snorre sylvester title: the state of one health research across disciplines and sectors – a bibliometric analysis date: - - journal: one health doi: . /j.onehlt. . sha: doc_id: cord_uid: hpbh o there is a growing interest in one health, reflected by the rising number of publications relating to one health literature, but also through zoonotic disease outbreaks becoming more frequent, such as ebola, zika virus and covid- . this paper uses bibliometric analysis to explore the state of one health in academic literature, to visualise the characteristics and trends within the field through a network analysis of citation patterns and bibliographic links. the analysis focuses on publication trends, co-citation network of scientific journals, co-citation network of authors, and co-occurrence of keywords. the bibliometric analysis showed an increasing interest for one health in academic research. however, it revealed some thematic and disciplinary shortcomings, in particular with respect to the inclusion of environmental themes and social science insights pertaining to the implementation of one health policies. the analysis indicated that there is a need for more applicable approaches to strengthen intersectoral collaboration and knowledge sharing. silos between the disciplines of human medicine, veterinary medicine and environment still persist. engaging researchers with different expertise and disciplinary backgrounds will facilitate a more comprehensive perspective where the human-animal-environment interface is not researched as separate entities but as a coherent whole. further, journals dedicated to one health or interdisciplinary research provide scholars the possibility to publish multifaceted research. these journals are uniquely positioned to bridge between fields, strengthen interdisciplinary research and create room for social science approaches alongside of medical and natural sciences. one health joins the three interdependent sectors -animal health, human health, and ecosystems -with the goal to holistically address health issues such as zoonotic diseases or antimicrobial resistance ( ) . in , the food and agriculture organization (fao), the world organisation for animal health (oie) and the world health organization (who) engaged in a tripartite collaboration to ensure a multisectoral perspective to effectively manage and coordinate a one health approach. one health is defined as "an approach to address a health threat at the human-animal-environment interface based on collaboration, communication, and coordination across all relevant sectors and disciplines, with the ultimate goal of achieving optimal health outcomes for both people and animals; a one health approach is applicable at the subnational, national, regional, and global level" ( ). this paper uses bibliometric analysis to explore the state of one health in academic literature, to visualise between the disciplines of human medicine, veterinary medicine and environment still persist -even in the face of the one health approach. the data for the bibliometric analysis is drawn from the web of science (wos). the wos is arguably one of the largest academic multidisciplinary databases, and it contains more than , million contributions from the natural sciences (science citation index expanded), social sciences (social sciences citation index) and humanities (arts & humanities citation index) ( ). the broad scope of the database aligns well with the one health concept's cross-disciplinary approach. the analytical period is demarcated by the first one health publication included in the wos in and it ends in december . the search term "one health" was applied to compile the first crude sample of articles that mention the concept of one health in their title, keywords or abstract. the basic assumption is that articles conducting one health research ( whether conceptually, methodologically and/or empirically) would as a minimum have mentioned "one health" in the abstract, title or keywords. the literature search resulted in . english articles, see flow chart in figure . however, this sample also included a sizable group of articles that just made use of "one health" in a sentence such as "one health district" or "one health professional". to restrict the sample to contributions only pertaining to the concept of one health, two subsequent screening measures were taken. first, contributions which used one health as a keyword were automatically included in the the bibliometric analysis was conducted with the bibliometrix package for the r programming language. the analysis focuses on: ) publication trends, ) co-citation network of scientific journals, ) co-citation network of authors, and ) co-occurrence of keywords. the publication trend is outlined using both absolute and relative number of one health publications. the co-citation networks of scientific journals provide information on the disciplinary structure of the field of one health while the co-citation network of authors disaggregates further to the citation patterns of individual authors. the co-citation network of journals shows the relation between the publications within the outlets. for example, when a publication within journal a cites publications within journals b and c, it indicates that journals b and c share similar characteristics. the more journals citing both b and c, the stronger their similarity. to minimise popularity bias among frequently cited journals, co-citation patterns are normalised through the jaccard index. the jaccard index measures the similarity between journals b and c as the intersection of journals citing both b and c, divided by the total number of journals that cited b and c individually ( , ) . like the co-citation network of journals, the co-citation network for authors measures the similarity of authors in terms of how often they are cited by other authors , also normalised through the jaccard index. when author a cites both authors b and c, it signifies that b and c share similar characteristics. the study also investigates the co-occurrence of keywords to identify the content of one health publications. here, co-occurrence measures the similarity of keywords based on the number of times they occur together in different articles. it provides information on the main other topical keywords linked to one health and can thus be used to gauge the knowledge structure of the field. here, the articles keywords plus are the unit of analysis. wos automatically generates keywords plus based on the words or phrases appearing most frequently in an articles bibliography. keywords plus are more fruitful for bibliometric analyses than author keywords, as they convey more general themes, methods and research techniques ( ) . disciplinary clusters within the networks, illustrated by the colours in figures to , are identified empirically applying the louvain clustering algorithm. louvain is a hierarchical clustering algorithm that attempts to maximise modularity, measured by the density of edges between nodes within communities and sparsity between nodes across communities. the nodes represent the aggregated citations of the academic journals and the edges, the line between two nodes, display the relation between the journals. the shorter the path between the nodes the stronger their relation. node size indicates "betweenness centrality" in the network, which is a measure of the number of shortest paths passing through each node ( ) . betweenness centrality estimates the importance of a node on the flow of information through the network, based on the assumption that information generally flows through the most direct communicative pathways. for example, the one health publications in our sample relating to ebola have more than tripled after . one might, therefore, expect to observe a similar spike in one health publications that study the covid- outbreak in . while the use of the one health concept has increased, the co-citation network shows that the increase is mostly driven by the sectors of human and veterinary medicine, evidenced by their centrality in terms of information flows within the network. relations to other clusters. the area of parasitology is also mostly co-cited in its own area. here, most aggregated citations are rooted in the journal plos neglected tropical diseases. in these last two clusters, microbiology and parasitology, the journals cover topics mainly exclusively pertaining to medical or biological sciences. the most active one health scholars, publishing more than ten articles over the last years, are from the field of veterinary research. of the top six researchers, five have a veterinary background (jakob zinsstag, jonathan rushton, esther schelling, barbara häsler and bassirou bonfoh). while degeling is the only researcher of the top six with an education in the social sciences, the remaining five veterinarian scholars do touch upon social science themes within their publications, relating to systemic or conceptual approaches, sociopolitical dimensions and knowledge integration (e.g. zinsstag and schelling ( ) ; häsler ( ) ; rushton ( ) . five of the six most productive researchers work in europe and three of them are associated with the same institute, namely the swiss tropical and public health institute (zinsstag, schelling and bonfoh) ( ) .there has been some cooperation across institutes and department as evidence by the coauthorships of zinsstag and häsler, häsler and rushton, rushton and zinsstag (e.g. ( ) ( ) ( ) ). figure illustrates the co-citation network of authors. four clusters of authors emerged in the network (green: zoonoses and epidemiology; blue: biodiversity and ecohealth; purple: animal health, public health; red: policy-related disciplines). academic scholars are mainly found in the green, blue and purple clusters, whereas the authors of the red clusters are mainly represented by organisations such as the who, cdc, perspectives from the environmental and ecological sector have been neglected within one health research ( , ) . further, the co-occurrence network of keywords illustrated that research into one health is mainly undertaken in the medical science cluster with the most connections to the other clusters. this indicates that a majority of articles is constructed around medical themes, and that there is most interdisciplinary research across areas in the medical science cluster. however, few keywords indicate research into administrative or anthropological approaches to examine the management of one health. making these thematic perspectives more central to the network could strengthen the one health approach regarding implementation and institutionalisation. one health initiatives and projects that specifically promote mixed methods studies and engage researchers with various expertise could facilitate implementing comprehensive initiatives. here, a gap in the one health research could be addressed, facilitating not only quantitative but a qualitative research to comprehensively approach the multifaceted issues implied in one health topics ( ) . there is no shortage of existing outlets, frameworks and approaches that promote interdisciplinary research. already in , a strategic framework was developed by the tripartite collaborators, as well as the un system influenza coordination, unicef and the world bank, outlining approaches for collaboration, to prevent crises, to govern disease control and surveillance programmes ( ) . rüegg et al. developed a handbook to adapt, improve and optimise one health activities could also provide some guidance on how to strengthen future one health activities and evaluate already ongoing one health initiatives ( ) . coker et al. produced a conceptual framework for one health, which can be used to develop a strong research the fao-oie-who collaboration -sharing responsibilities and coordinating global activities to address health risks at the animal-human-ecosystems interfaces -a tripartite concept note applied informetrics for digital libraries: an overview of foundations, problems and current approaches transdisciplinary and social-ecological health frameworks-novel approaches to emerging parasitic and vector-borne diseases posthumanist critique and human health: how nonhumans (could) figure in public health research citation index is not critically important to veterinary pathology on the normalization and visualization of author co-citation data: salton's cosine versus the jaccard index similarity measures in scientometric research: the jaccard index versus salton's cosine formula. information processing & management comparing keywords plus of wos and author keywords: a case study of patient adherence research fast unfolding of communities in large networks ebola outbreak distribution in west africa ebola virus disease) reporting and surveillance -zika virus from "one medicine" to "one health" and systemic approaches to health and well-being knowledge integration in one health policy formulation, implementation and evaluation towards a conceptual framework to support one-health research for policy on emerging zoonoses swiss tph -swiss tropical and public health institute integrated approaches to health: a handbook for the evaluation of one health a review of the metrics for one health benefits a blueprint to evaluate one health. front public health implementing a one health approach to emerging infectious disease: reflections on the socio-political, ethical and legal dimensions overcoming challenges for designing and a framework for one health research. one health the growth and strategic functioning of one health networks: a systematic analysis. the lancet planetary health qualitative research for one health: from methodological principles to impactful applications. front vet sci contributing to one world, one health* -a strategic framework for reducing risks of infectious diseases at the animal -human-ecosystems interface birds of a feather: homophily in social networks homophily in co-autorship networks key: cord- -tmlatghe authors: ojha, rashi; syed, saba title: challenges faced by mental health providers and patients during the coronavirus pandemic due to technological barriers date: - - journal: internet interv doi: . /j.invent. . sha: doc_id: cord_uid: tmlatghe background: the novel coronavirus, sars-cov- , has been responsible for the devastation of hundreds of thousands of lives directly and has caused disruptions globally. vulnerable populations, specifically those suffering from serious mental illness and homelessness, are at higher risk of contracting covid- infection resulting in medical complications and psychiatric destabilization. in addition, mental health has become increasingly relevant throughout the country given the psychological distress people have been facing due to the spread of covid- and the toll of a more restricted way of living. although the healthcare industry has quickly integrated novel ways of treating patients with mental illness with technological advances, these technologies are not applicable to different populations equally. there is a clear disparity that is represented within the public county health systems, which leads to a widening gap between those who receive adequate treatment for mental illness and those who do not. aims: the aims of this paper were to provide a commentary on the benefits of technology-based psychiatric and psychological interventions based off experience in a public health system and based off a relevant, thorough literature review. in addition, we aim to highlight the importance of accessibility of these interventions for vulnerable populations and provide recommendations for integrating these services expeditiously. methods: literature review was conducted using medline, pubmed and google scholar. conclusions: based off data collected from experience in a public health system and literature review, we conclude that although the covid- pandemic has initiated significant innovation to integrate technology for psychiatric care, this innovation is not equally accessible for vulnerable populations suffering from mental health disorders. within a public county health system, there are barriers with providing mental healthcare to vulnerable populations. these barriers, which are applicable throughout the united states, serve as a rationale for the need of innovative solutions for the integration of these services in not only emergency situations such as the covid- pandemic, but also in daily non-emergent operations to sufficiently address the needs for those needing mental healthcare. j o u r n a l p r e -p r o o f based off data collected from experience in a public health system and literature review, we conclude that although the covid- pandemic has initiated significant innovation to integrate technology for psychiatric care, this innovation is not equally accessible for vulnerable populations suffering from mental health disorders. within a public county health system, there are barriers with providing mental healthcare to vulnerable populations. these barriers, which are applicable throughout the united states, serve as a rationale for the need of innovative solutions for the integration of these services in not only emergency situations such as the covid- pandemic, but also in daily non-emergent operations to sufficiently address the needs for those needing mental healthcare. the unprecedented outbreak of the covid- pandemic has been a catalyst for an overnight transition to telehealth services across heath care systems. while people across demographics have needed increased health services, most health systems, particularly those dealing with underserved populations, are technologically ill-equipped. patients with severe mental illness die earlier, have more medical illnesses, and receive worse medical care than those in the general population ( ). this healthcare disparity is accentuated in the area of mental health services, where the clinical systems lack technological sophistication to meet the challenges of the pandemic. social isolation and psychological stress related to the pandemic can lead to anxiety, fear and depression. in addition, mentally ill patients, particularly the homeless, socially disadvantaged, drug addicted or communication-based technologies, which includes telephone communication, interactive audio and video interfaces, text messages and remote monitoring of patient data comprise of the wide range of telemedicine or telehealth ( ) . telepsychiatry, or telemedicine interventions for psychiatry, can include psychiatric evaluations, therapy, patient education and medication management. telepsychiatry is highly efficient and clinically acceptable, with % of clinically stable patients, particularly with a known psychiatric disorder, able to be managed with teleconsultation alone ( ) . some of these interventions can include direct, real-time interaction between a psychiatrist and patient (eg. videoconferencing). other types of digital or tele-based mental health interventions, which can complement telepsychiatry, include online mental health surveys, telephonebased hotlines, online mental health educational materials and psychological counseling services ( ). these complementary interventions, particularly those involving smartphone applications, have shown to have a moderate positive effect on some mental health disorders, such as depression. ( ) in the united states, the repertoire of tools used within telemedicine were primarily reserved for physician-patient interactions where distance was the major barrier. while these tools have been used for decades, there are multiple legal and policy-related reasons why they have not been integrated widely ( ) . telehealth has been implemented in a j o u r n a l p r e -p r o o f painstaking fashion, and though substantial effort has gone into scaling telehealth services, less than % of individuals living in rural areas (where telehealth services are primarily catered towards) have experienced such services ( ) . the covid- pandemic has increased the expeditious adoption of telemedicine, telepsychiatry and digital health interventions, but there are existing barriers to continue the utilization of these services. telepsychiatry can be implemented in a cost-effective way but increasing awareness and creating "how-to" guides catered towards different populations is essential. for example, in the los angeles county, . % of the population is hispanic and/or latino and . % is asian, and creating "how-to" guides in english, spanish and different asian languages would be helpful in ensuring each of these populations were able to understand how to access online mental health services. incomes below $ , do not own a smartphone, % don't have home broadband services and % do not own a computer. comparing these results to households with an annual income of $ , or more, these technologies, including tablets, are nearly ubiquitous. ( ) this disparity is particularly relevant to the lac health system, as a significant portion of the population includes those from a low socioeconomic status, including minority populations and the homeless. temporary funding sources may be adequate to address emergencies such as this pandemic. ( ) this would provide funding for specific services or target vulnerable patient populations to mitigate high-risk, high-demand situations. ( ) the incorporation of telehealth services in a sustainable fashion requires a multi-level, interdisciplinary strategy. in order for telehealth services to be embedded in daily operations for healthcare in conclusion, the covid- pandemic has been challenging globally and has forced many to consider different ways to approach their jobs. this is extremely relevant to healthcare professionals, many of whom are on the frontlines and selflessly treating patients. mental health has risen to the forefront of many people's lives, and they are forced to confront the ephemeral predictions of shelter-in-place predictions and change their routines. unfortunately, despite the increased awareness mental health has received, many patients with severe mental illness have fallen through the cracks. in order to best serve our patients today and prevent these problems from happening to future patients, those who desperately require appropriate treatment and planning and those who often lack sufficient support systems, we utilize the los angeles county health system as a model to be a stimulus for enduring, positive change. j o u r n a l p r e -p r o o f the impact of serious mental illness on health and healthcare covid- is catalyzing the adoption of teleneurology response to: rethinking online mental health services in china during the covid- epidemic online mental health services in china during the covid- outbreak the efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials telehealth for global emergencies: implications for coronavirus disease (covid- ) medicare telemedicine health care provider fact sheet the outbreak of covid- coronavirus and its impact on global mental health -ncov epidemic: address mental health care to empower society inevitable isolation and the change of stress markers the psychological effect of severe acute respiratory syndrome on emergency department staff rethinking online mental health services in china during the covid- epidemic remote consultations in the era of covid- pandemic: preliminary experience in a regional australian public acute mental health care setting patients with mental health disorders in the covid- epidemic older adults perceptions of technology and barriers to interacting with tablet computers: a focus group study digital divide persists even as lower-income americans make gains in tech adoption % of seniors are now online and using technology cms expands covid- telehealth reimbursement to therapists technology use and attitudes among mid-life and older americans progression of mental health services during the covid- outbreak in china mental health problems of prison and jail inmates notification of enforcement discretion for telehealth key: cord- -sfhwaqfr authors: henssler, jonathan; stock, friederike; van bohemen, joris; walter, henrik; heinz, andreas; brandt, lasse title: mental health effects of infection containment strategies: quarantine and isolation—a systematic review and meta-analysis date: - - journal: eur arch psychiatry clin neurosci doi: . /s - - -x sha: doc_id: cord_uid: sfhwaqfr due to the ongoing covid- pandemic, an unprecedented number of people worldwide is currently affected by quarantine or isolation. these measures have been suggested to negatively impact on mental health. we conducted the first systematic literature review and meta-analysis assessing the psychological effects in both quarantined and isolated persons compared to non-quarantined and non-isolated persons. pubmed, psycinfo, and embase databases were searched for studies until april , (prospero registration-no.: crd ). we followed prisma and moose guidelines for data extraction and synthesis and the newcastle–ottawa scale for assessing risk of bias of included studies. a random-effects model was implemented to pool effect sizes of included studies. the primary outcomes were depression, anxiety, and stress-related disorders. all other psychological parameters, such as anger, were reported as secondary outcomes. out of screened articles, studies were included in our analyses. compared to controls, individuals experiencing isolation or quarantine were at increased risk for adverse mental health outcomes, particularly after containment duration of week or longer. effect sizes were summarized for depressive disorders (odds ratio . ; % ci . – . ), anxiety disorders (odds ratio . ; % ci . – . ), and stress-related disorders (odds ratio . ; % ci . – . ). among secondary outcomes, elevated levels of anger were reported most consistently. there is compelling evidence for adverse mental health effects of isolation and quarantine, in particular depression, anxiety, stress-related disorders, and anger. reported determinants can help identify populations at risk and our findings may serve as an evidence-base for prevention and management strategies. electronic supplementary material: the online version of this article ( . /s - - -x) contains supplementary material, which is available to authorized users. quarantine and isolation are main containment strategies intended to help protect the public by preventing the spread of contagious diseases. both strategies primarily refer to a restriction of movement and limitation of personal contacts [ ] . quarantine, per definition, is used for persons that may have been exposed to the disease, while isolation is used for contagious persons that require separation from persons who are not infected. findings from previous research pointed towards an increased risk for negative psychological outcomes, such as depression and anxiety, through isolation [ ] [ ] [ ] . quarantined persons may equally be at heightened risk for adverse mental health outcomes. a rapid review by brooks et al. reported increased negative psychological outcomes including post-traumatic stress symptoms, confusion, and anger in persons under quarantine [ ] . the authors concluded that important stressors were longer quarantine electronic supplementary material the online version of this article (https ://doi.org/ . /s - - -x) contains supplementary material, which is available to authorized users. duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma [ ] . findings suggest that both containment strategies, quarantine and isolation, have negative impacts on psychological outcomes related to a broad spectrum of psychosocial stressors [ ] [ ] [ ] [ ] . the need for investigation of mental health problems associated with containment strategies is further highlighted by the rising implementation of quarantine and isolation worldwide due to the currently ongoing covid- pandemic. an unprecedented number of people worldwide is affected by quarantine or isolation [ ] . the identification of individuals at elevated risk for adverse mental health effects seems mandatory. it has been suggested that vulnerable populations at risk for negative psychological outcomes before implementation of containment strategies, e.g. persons with mental illness, low income, or lack of social network, may be at particular greater risk during and after quarantine or isolation [ ] . the world health organization (who) has included covid- in the list of diseases and pathogens prioritized for research and development (r&d) in public health emergency contexts, which pose the greatest public health risk due to their epidemic potential, as insufficient countermeasures have been established [ ] . containment strategies are among the main countermeasures in this context [ ] and systematic investigation of evidence concerning their psychological effects is urgently in need. single studies and reviews [ , ] suggest an increased risk of negative psychological outcomes in persons under quarantine or isolation, but others presented partially contradicting results [ , ] . furthermore, prevalence estimates point towards elevated levels of adverse outcomes in quarantined or isolated populations [ ] , however, validity of these findings is often limited by the underlying uncontrolled study design. we, therefore, conducted a systematic literature review and meta-analysis of the mental health effects of quarantine and isolation, based on controlled primary study data. to the best of our knowledge, no meta-analysis including both quarantine and isolation exists to date. this is a systematic literature review and meta-analysis. the protocol of the project has been published on prospero (prospero registration-no.: crd ). methods followed guidelines by the cochrane collaboration for the conduction of systematic reviews [ ] . we searched pubmed, psycinfo, and embase databases for studies with no restrictions, from the beginning of the searched time period and until april , , assessing the rate of psychological effects in quarantined/isolated persons compared to non-quarantined/non-isolated persons. search entry is described in an online supplement (supplement . database search entry). broad and specific search terms were combined to increase the likelihood of detecting eligible studies for our research aim. among the specific search terms, we included a list of diseases and pathogens prioritized for research and development (r&d) in public health emergency contexts by the world health organization (who), such as covid- [ ] . additional records were identified through manual searches of references of the included studies. we included no language restrictions and translations by a native speaker were acquired to test eligibility criteria of articles in languages other than english. study authors were contacted in case of missing data. the search was carried out using endnote x . (clarivate analytics, philadelphia, usa). trials were considered appropriate to test the hypothesis and included when they met the following criteria. first, observation of persons in quarantine or isolation was described. second, quantitative assessment of psychological outcome parameters was performed. third, comparators were persons not in quarantine or isolation. fourth, data for the calculation of effect sizes and corresponding measures of dispersion were provided. studies observing psychological outcome parameters by qualitative assessment only were excluded. studies were excluded if they focused on specific subpopulations without primary infection control-association, such as isolated persons in prisons. studies assessing correlations of mental health outcomes with varying durations of quarantine or isolation only were excluded from quantitative synthesis and reported in our qualitative synthesis of determinants. the entire literature search and study screening were carried out independently by two reviewers (fs, jvb). consensus in unclear cases was reached via discussion with additional members of the reviewing team (lb, jh). testing of eligibility criteria, study selection, and classification and coding of data into a predefined excel spreadsheet (microsoft excel for mac, version . , microsoft corporation, usa) followed recommendations by the cochrane collaboration handbook [ ] and were performed independently by two reviewers (lb, jh). two reviewers (jh, lb) independently extracted data regarding characteristics of the study and study samples, as well as quantitative data on severity (mean scores) or frequency (incidence or prevalence) of mental health outcomes for each group or for the comparison between groups (e.g. relative risk, odds ratio), and the results of any determinant testing reported to reach statistical significance in the original studies. when multiple measures for the same outcome were reported, we extracted data in the following hierarchy: ( ) continuous measures (mean scores), ( ) categorical measures using the highest cut-offs defined by the authors of the original studies (i.e. the most severe manifestation of the disorder). risk of bias of studies was classified independently by two reviewers (lb, jh) according to the newcastle-ottawa scale (nos) [ ] as recommended by the cochrane handbook [ ] (table ) . by summary assessment, all studies were classified as holding low or unknown/high risk of bias by taking into account bias from the three main domains selection, comparability, and exposure/outcome. disagreements were resolved by consensus with additional review authors. we calculated standardized mean differences (smd) and % confidence intervals (cis) from outcome measures of the primary studies. if respective measures of dispersion were not available, we calculated cis from p values as recommended in the cochrane handbook [ ] . stratified by our pre-defined mental health outcomes, effect sizes for comparisons between quarantined/isolated and non-quarantined/isolated groups were summarized using forest plots and tables. a quantitative synthesis of all these results was not possible due to the heterogeneity of the included studies in methodology, populations, and outcomes. we, therefore, restricted quantitative syntheses to our pre-defined outcomes and to primary studies that provided data on categorical outcomes based on validated diagnostic criteria for mental disorders. from these, we calculated summary estimates (odds ratio and % ci) using randomeffects models (dersimonian and laird method), as the studies differed in several methodological aspects. effect sizes from different, non-overlapping subgroups of populations within a study were pooled using a fixed-effect model, as recommended in the cochrane handbook [ ] (three-level meta-analytic approach). heterogeneity among studies was quantified with the i statistic. analyses were conducted according to the cochrane collaboration handbook [ ] and using comprehensive meta-analysis v (biostat, engelwood, new jersey). descriptive text was used to summarize the results of any determinant testing reported to reach statistical significance in the original studies. after screening of titles and abstracts of articles, full-texts were assessed for eligibility. of these, studies, published between and , were eligible for quantitative synthesis (fig. ). studies observed isolation procedures, studies observed quarantine procedures and one study observed quarantine and isolation procedures. mean length of containment measures ranged from to . days (table ) . three additional studies provided data on determinants only and were not included in quantitative synthesis [ ] [ ] [ ] . pre-defined primary outcomes were depression, anxiety, and stress-related disorders. figure presents effect sizes from all studies providing data for these outcomes. secondary outcomes were all other mental health outcomes, as presented in fig. . quantitative synthesis of our pre-defined outcomes took into account primary study data on categorical outcomes based on validated diagnostic criteria for mental disorders (fig. ) . compared to non-quarantined/-isolated controls, individuals experiencing isolation or quarantine were at higher risk of depressive disorders (or . ; % ci . - . ; i : . %), anxiety disorders (or . ; % ci . - . ; i : . %), and stress-related disorders (or . ; % ci . - . ; i : . %). final ratings after assessment of methodological quality of included studies are summarized in table . out of studies were considered to be of low risk of bias. sensitivity analyses, restricted to studies of higher methodological rigor (i.e. low risk of bias), supported our main findings, i.e. an increase in all primary outcomes was observed in both quarantine and isolation. both containment measures determined adverse mental health outcomes. driven by the unequal number of available studies per group (i.e. quarantine or isolation), evidence-base is particularly strong for elevated levels of stress-related disorders in quarantined individuals and for depression and anxiety in isolated individuals (fig. ). determinants of psychological outcomes, reported to reach statistical significance in the primary studies, were: (results are from study, if not otherwise specified). younger age was associated with higher risk for stressrelated disorders/ptsd ( studies [ ] [ ] [ ] ), whereas persons > years were at higher risk for depression [ ] . women were at higher risk for depression [ ] , ptsd [ ] , and general mental health impairments [ ] ( study each), while men were found to be at higher risk for (non-psychotic) psychological disorder of any kind [ ] and at higher risk for alcohol use disorder [ ] ( study each). lower levels of education were associated with more severe symptoms of stress-related disorders/ptsd [ ] and higher risk of depression [ ] ( study each). lower household income and financial loss or economic impact in pandemics was correlated with a higher risks for negative psychological effects, i.e. depression ( studies [ , ] ), anxiety [ ] , anger [ ] , symptoms of stress-related [ ] , and unspecified psychological disorders [ ] ( study each). lower income was also associated with higher persistence of symptoms of ptsd over years [ ] . interestingly, higher household income was associated with higher risk of alcohol use disorder [ ] . low levels of social capital, lower perceived social support, and lower neighborhood relationships were associated with higher levels of depression ( studies [ , ] ) as well as anxiety, stress, and poor sleep quality ( study [ ] ). being single also determined higher levels of depression [ ] and higher persistence of ptsd symptoms over years [ ] ( study each). health care workers (hcw) experienced higher levels of stigmatization [ ] . one study reported higher levels of anger and anxiety with use of mail/texting and internet but not with telephone use in isolated, non-infected individuals [ ] . previous mental illness and psychiatric inpatient admission was associated with greater anxiety ( studies [ , ] ) and anger [ ] levels. a history of trauma determined higher risk of depression [ ] . depression and ptsd symptoms and a history of alcohol use as a coping strategy were associated with a higher risk of consecutive alcohol use disorder [ ] . lower perceived current health status was associated with higher levels of depression [ ] . exposure to infected individuals (e.g., friends/relatives or patients for hcw) and higher perceived risk of infection were associated with higher rates of adverse mental health outcomes: risk of adverse mental health effects was highest with having been infected oneself [ , ] . health care workers (hcw) were at higher risk compared with administrative personnel and hcw were at higher risk the more intense they worked with infected patients. this association was reported for anxiety and anger [ ] , depression ( studies [ , ] ), stress-related disorders/ptsd ( studies [ , , ] ), emotional exhaustion ( studies [ , ] ), insomnia [ ] , alcohol use disorder (aud) [ ] , and any psychological disorders [ ] . hcw with infection-related tasks were also reported to be at higher risk for persisting symptoms of ptsd one month after the end of infection containment measures [ ] . perception of the risk of health hazards due to infection was associated with a higher risk of symptoms of stress-related disorders/ptsd [ ] . for isolated/quarantined individuals, dissatisfaction with containment measures, supply, or the relationship to healthcare-personnel was associated with higher levels of anxiety and anger [ ] , stress-related disorders/ptsd ( studies [ , ] ) and lower general mental health [ ] . for hcw, lower trust in equipment and infection control initiatives determined higher levels of anger and emotional exhaustion, whereas higher organizational support was associated with lower anger and lower avoidance behavior [ ] . increased length of quarantine or isolation positively correlated with higher levels of anger ( studies [ , ] ), anxiety [ ] , avoidance behavior [ ] and stress-related disorders/ ptsd [ ] . independent of infection status, isolation was found to have negative psychological effects after and particularly after weeks [ ] . some studies [ , ] did not find negative mental health effects in isolation of - days duration, whereas others [ , , ] did. altruistic acceptance of infection-risk was reported to be protective against depression [ ] and stress-related disorders/ptsd [ ] . increased perceived stress was associated with higher levels of depression and anxiety [ ] . selfesteem and sense of control were inversely correlated with anxiety and depression [ ] . children of parents with symptoms of ptsd had themselves an elevated risk for ptsd [ ] . this systematic review and meta-analysis yielded the following main results: individuals experiencing quarantine or isolation are at heightened risk of depression, anxiety, stressrelated disorders and anger compared to non-quarantined or non-isolated persons. data for other mental health outcomes mainly resulted from single trials, but likewise strongly and coherently indicated increased adverse mental health effects in quarantined and isolated individuals. the included studies were heterogeneous in methodology, definition of containment strategies, and outcome parameters. determination of exact risk estimates is, therefore, limited and pooled effect size estimates should only serve as guiding values. in spite of this cautionary remark, our results provide compelling evidence for increased adverse mental health outcomes in isolated or quarantined individuals. sensitivity analyses, restricted to studies of higher methodological rigor, supported the main findings. thus, even in light of the methodological diversity of the included studies, findings appear to be sufficiently robust to impact on and inform clinical decision-making. since only studies were considered "low" risk of bias, more studies of high methodological rigor are needed to determine precise risk estimates. our general findings are in line with previous research: brooks et al. performed a rapid review of the literature including qualitative data and concluded that post-traumatic stress symptoms, confusion, and anger appear to be increased in persons under quarantine [ ] . in the same vein, cases of suicide associated with quarantine were reported during an outbreak with severe acute respiratory syndrome (sars) outbreak - [ ]. purssell et al. previously reported increased rates of anxiety and depression in hospital-isolated patients [ ] . these findings confirm an increased risk of mental health problems for persons under quarantine or isolation. to some extent, heterogeneity in observed effects from included studies may be attributable to different durations of quarantine or isolation. some studies [ , ] did not find negative mental health effects in isolation of - days duration, but others [ , , ] did. after periods of and particularly of weeks, however, evidence for adverse mental health effects of isolation and quarantine becomes increasingly solid [ , , ] . our analyses of determinants overall indicated that persons with higher levels of psychosocial vulnerabilities and stressors appear to be at particular risk for negative psychological outcomes associated with quarantine and isolation. this is in agreement with previous findings, indicating that the association between stress and mental health problems is determined by a variety of psychological, behavioral, and biological determinants including psychosocial resources, patterns of coping, and comorbidities [ ] . our review suggests that lower levels of education [ , ] , low income and financial loss [ , , , , ] , and lack of social networks are important determinants of negative psychological outcomes including depression, anxiety, and stress-related disorders, partly persisting over years [ ] . histories of mental illnesses or previous traumas likewise were factors associated with an increased risk of adverse mental health outcomes, highlighting the importance of particular awareness towards the vulnerability of these individuals during quarantine or isolation. importantly, studies that corrected for levels of psychological outcomes at baseline still detected increasing levels of negative psychological outcomes following with containment strategies [ , ] . even beyond that, however, persons with mental health disorders may experience increased difficulties in accessing mental health services, as well as day care centers and psychosocial networks, which are important for mental health outcomes. in line with previous studies [ ] emphasizing the negative impact of social isolation and exclusion stress on mental disorders, containment procedures may, therefore, represent an independent risk factor for adverse mental health effects and are likely to affect larger parts of the general population. this independent risk factor, however, may particularly add up to pre-existing vulnerability. we found cumulated evidence for elevated levels of anger in populations under quarantine or isolation, even increasing with ongoing duration of containment [ , ] . this is of particular relevance during the current worldwide covid- pandemic, as could be shown by concerns of increasing domestic violence and child abuse based on initial reports in populations affected by covid- quarantine in asia and europe [ , ] . a major important finding is the elevated risk of negative psychological effects for healthcare workers, particularly those with exposure to infected patients [ , , , , , , , , , ] . awareness has to be drawn to the finding [ ] that their risk of negative psychological effects was determined by the perception of personal health hazards, organizational support, and trust in equipment, outlining the path for crucial prevention and management strategies to minimize adverse mental health effects for healthcare workers. this review has several strengths and limitations. strengths include the extensive database search and the duplication of screening, data extraction, and the thorough evaluation of the methodology and risk of bias of the studies. also, by restricting eligibility of primary studies to those that used non-quarantined/-isolated populations as a comparator, we were able to calculate relative effect estimates with higher explanatory power. however, this review also has several limitations. studies reporting psychological outcomes only as secondary outcomes may not have been identified in the searches of electronic publication databases if these psychological outcomes were not reported in the title, abstract, keywords, or indexing terms. the use of the three large and relevant databases in this field and supplementary manual searches of all reference lists of included studies and related articles, however, should have minimized the risk of missing relevant studies. our meta-analysis confirmed the initial assumption that persons under quarantine or isolation are at risk for mental health problems. the representativeness and validity of our findings are, however, limited by the following aspects: limitations of the currently available evidence include ( ) partial use of cross-sectional study designs, thus making temporality of events difficult to assess, ( ) lack of power, and ( ) frequent lack of consideration for important confounders, such as baseline mental health status. the majority of included studies investigated singleperson isolation measures. the scarcity of studies focusing specifically on quarantine in general population settings is a limitation of the current evidence and has to be accounted for when generalizing the findings of our meta-analysis. additionally, during times of a pandemic, such as the current covid- pandemic, populations may experience various degrees of restricted movement or limited personal contacts that do not necessarily coincide with systematically implemented quarantine or isolation. clearly, conduction of adequately controlled studies is particularly challenging with regards to population-based quarantine measures. our findings, however, are in accordance with and strengthened by results from additional uncontrolled studies [ , , ] , indicating that these differential containment strategies share indeed common adverse mental health effects. more research is needed to assess the differential effects of various degrees of movement restrictions and contact limitations on psychological outcomes in single person as well as population-based settings. moreover, the studies in this meta-analysis are heterogenous with regard to study designs including definitions of the containment strategy, populations, and outcome parameters. drawing conclusions from this meta-analysis to different subpopulations, such as children and geriatric subpopulations, and different procedures for implementing quarantine or isolation is, therefore, limited and should consider characteristics of the specific population and its specific reaction to a clearly defined containment strategy. psychosocial factors relevant for the reaction to containment strategies and resulting mental health problems may significantly differ between subpopulations. to date, however, there is very limited specific evidence for each of the subpopulations only. more controlled studies for specific subpopulations categorized according to mental and physical health, social support, and economic status are needed to further assess the generalizability of the findings. generalizability would be further increased by implementation of standard diagnostic criteria of mental health problems, such as the diagnostic and statistical manual of mental disorders (dsm) [ ] or the international statistical classification of diseases and related health problems (icd) [ ] . persons under quarantine or isolation appear to be especially vulnerable for mental health problems associated with psychosocial adversities, such as social isolation, financial loss, inadequate supplies and information, stigma, and fear of infection [ ] . this systematic review of the evidence identified a full range of adverse psychological effects in persons under quarantine or isolation. further investigation should focus on the identification of moderating and protective factors and the development of effective prevention and management strategies aligned to populations of particular vulnerability. psychosocial challenges associated with containment strategies are of exceptional relevance due to the ongoing covid- pandemic and the resulting frequent implementation of quarantine and isolation. implementation of containment strategies should, thus, include consideration of increasing negative psychological outcomes associated with especially long durations of quarantine and isolation. large groups of the general population may be affected, but individuals who are already facing psychosocial adversities before quarantine or isolation (including persons with low income, lack of social networks, or mental health problems) appear to be among those vulnerable groups at greatest risk for negative psychological outcomes. health care workers showed a strong increase in negative psychological outcomes and stigma [ ] . these effects might even be stronger in the ongoing covd- pandemic taking into account that current measures of quarantine and in particular isolation are longer and affect large populations worldwide. based on these findings, potential negative effects on mental health outcomes from infection containment strategies may possibly be reduced by several measures. our findings highlight the need for organizational structures that can adapt to crisis management, sufficient equipment, and support for health care workers. evidence strongly supports the inverse relationship between trust in equipment or organizational support and adverse mental health effects in this population at particular high risk for negative psychological outcomes. for persons with mental health disorders, maintenance of access to mental health care services should be of high priority. targeted mental health prevention and intervention strategies for these populations at risk are urgently needed [ ] . moreover, the findings of this meta-analysis support the implementation of recently recommended measures to mitigate the potential negative psychological effects of quarantine, such as keeping the duration of the containment as short as possible, but as long as needed, providing adequate supplies for basic needs for quarantined households, providing persons with as much information as possible regarding the reason for the quarantine, and effective and rapid communication [ ] . persons under quarantine or isolation are at heightened risk of mental health problems, in particular depression, anxiety, stress-related disorders and anger. experiencing quarantine or isolation was found to represent an independent risk factor for adverse mental health outcomes. these findings highlight the need for mental health prevention strategies for populations at risk, particularly health care workers exposed to infection and individuals who already were facing psychosocial adversities before quarantine or isolation including those with low income, lack of social networks, or mental health problems. author contributions jh and lb had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. concept and design: jh, ah, and lb. acquisition, analysis, or interpretation of data: jh, fs, jvb, hw, ah, and lb. drafting of the manuscript: jh, ah, and lb. critical revision of the manuscript for important intellectual content: jh, fs, jvb, hw, ah, and lb. statistical analysis: jh and lb. obtained funding: none. supervision: ah. funding open access funding enabled and organized by projekt deal. this study was supported in part by the collaborative research centre trr (crc-trr ). henrik walter has received funding from the european union's horizon research and innovation programme under grant agreement no . this publication reflects only the authors' view and the european commission is not responsible for any use that may be made of the information it contains. conflict of interest the author(s) declare that they have no competing interests. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/ . /. learning from sars: preparing for the next disease outbreak-workshop summary impact of isolation on hospitalised patients who are infectious: systematic review with meta-analysis adverse effects of isolation in hospitalised patients: a systematic review mental health outcomes of quarantine and isolation for infection prevention: a systematic umbrella review of the global evidence the psychological impact of quarantine and how to reduce it: rapid review of the evidence covid- -the law and limits of quarantine world health organization 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factors influencing compliance with quarantine in toronto during the sars outbreak diagnostic and statistical manual of mental disorders world health organization ( ) international statistical classification of diseases and related health problems, th edn do contact precautions cause depression? a two-year study at a tertiary care medical centre association between contact precautions and delirium at a tertiary care center psychological impact of the management of methicillin-resistant staphylococcus aureus (mrsa) in patients with spinal cord injury effects of isolation on patients and staff methicillin-resistant staphylococcus aureus: psychological impact of hospitalization and isolation in an older adult population key: cord- - o bpedp authors: hanage, william p.; testa, christian; chen, jarvis t.; davis, letitia; pechter, elise; seminario, peg; santillana, mauricio; krieger, nancy title: covid- : us federal accountability for entry, spread, and inequities—lessons for the future date: - - journal: eur j epidemiol doi: . /s - - - sha: doc_id: cord_uid: o bpedp the united states (us) has been among those nations most severely affected by the first—and subsequent—phases of the pandemic of covid- , the disease caused by sars-cov- . with only % of the worldwide population, the us has seen about % of covid- deaths. despite formidable advantages in resources and expertise, presently the per capita mortality rate is over /million, respectively . and times higher compared to canada and germany. as we enter fall , the us is enduring ongoing outbreaks across large regions of the country. moreover, within the us, an early and persistent feature of the pandemic has been the disproportionate impact on populations already made vulnerable by racism and dangerous jobs, inadequate wages, and unaffordable housing, and this is true for both the headline public health threat and the additional disastrous economic impacts. in this article we assess the impact of missteps by the federal government in three specific areas: the introduction of the virus to the us and the establishment of community transmission; the lack of national covid- workplace standards and enforcement, and lack of personal protective equipment (ppe) for workplaces as represented by complaints to the occupational safety and health administration (osha) which we find are correlated with deaths days later (ρ = . ); and the total excess deaths in to date already total more than , , while covid- mortality rates exhibit severe—and rising—inequities in race/ethnicity, including among working age adults. the united states (us) has been among those nations most severely affected by the first-and subsequent-phases of the pandemic of covid- , the disease caused by sars-cov- . with only % of the worldwide population, the us has seen about % of covid- deaths. despite formidable advantages in resources and expertise, presently the per capita mortality rate is over /million, respectively . and times higher compared to canada and germany [ , ] . as we enter fall , the us is enduring ongoing outbreaks across large regions of the country. moreover, within the us, an early and persistent feature of the pandemic has been the disproportionate impact on populations already made vulnerable by racism and dangerous jobs, inadequate wages, and unaffordable housing, and this is true for both the headline public health threat and the additional disastrous economic impacts [ ] [ ] [ ] [ ] [ ] [ ] . the newly issued federal healthy people framework (released on august , ) [ ] , sets the nation's objectives for the next decade, with the first two overarching goals being: ( ) "attain healthy, thriving lives and well-being free of preventable disease, injury, and premature death" and ( ) "eliminate health disparities, achieve health equity, and attain health literacy to improve the health and well-being of all." the third is: "create social, physical and economic environments that promote attaining the full potential for health and well-being for all" [ ] . in the case of covid- , the us has missed the mark on all three goals. in the following we document critical federal missteps in protecting the nation, with an eye towards guiding a better response. we start with how community transmission in the us became established in the spring. we then document complaints submitted to the us occupational safety and health administration by us workers regarding their risk of exposure to covid- at work, a key site of transmission, and compare the temporal relationship of these complaints to covid- cases and deaths. we conclude with an empirical analysis of excess mortality and age-specific racial/ethnic inequities in covid- mortality. living graffiti at jamaica pond (boston, ma): early may, while covid- lockdown underway --"we cannot direct the wind, but we can adjust the sail" (photograph taken by n. krieger) to prevent or delay establishment of the virus, many countries have implemented symptom screening at ports of entry, sometimes together with quarantine of travelers. such measures have enabled singapore, hong kong, and taiwan to avoid large early outbreaks, despite having been at high risk of introductions due to the volume of travelers from wuhan (hubei province, china), the initial epicenter of the pandemic. in the us, control of borders, including in relation to public health, rests with the federal government, an authority assumed since the founding of the country [ ] [ ] [ ] [ ] [ ] . the administration implemented a travel ban affecting only non-us travelers from china on january , , without any mandatory symptom screening at entry or quarantine of travelers, despite the virus at this time already known to be present in italy, iran, spain, germany, finland, and the united kingdom. similarly, selective restrictions on travel from europe were only instituted a full weeks later, on march , , at which point deaths had been reported in italy alone (by contrast, on january , china had reported deaths). none of these restrictions applied to returning us citizens or permanent residents, despite their potential exposure to sars-cov- [ ] . hence there were ongoing opportunities for introductions of the virus to the us from europe. consistent with this, phylogenetic studies have found repeatedly that the great majority of sars-cov- introductions to the us were viral lineages circulating in europe [ ] . a study of the genomic epidemiology of the early pandemic in the boston area estimated a total of independent importations from europe, of which occurred prior to march [ ] [ ] [ ] . imports included a superspreading event at a conference on february - leading to more than known infections among attendees or their contacts. the index cases were two international business travelers. this introduction is estimated to be the direct ancestor of % of sampled genomes not associated with the conference, including samples from outbreaks in homeless shelters, so it is reasonable to suggest that this introduction alone hastened the establishment of the virus in the region and the scale of the subsequent surge of infections. as has been previously shown, by early march the most likely source of introduction to a region was from elsewhere in the united states [ ] . this shows that any action to delay or prevent introductions would need to be at the national level, and while the window for effective action was brief, it was missed. symptom screening alone is unlikely to provide a significant barrier to a virus like sars-cov- that is capable of presymptomatic transmission [ ] , but may be an effective component of mitigation if supplemented by a coherent central strategy to delay case importation. while like-for-like comparisons of government responses to covid- should be interpreted with caution, the benefits of such an approach are well-illustrated by australia: like the us, australia is a large and well-developed economy with major metropolitan cities, substantial international travel, and wide variations in population density. also similar to the us, important elements of pandemic response were devolved to individual states, but border control is the responsibility of the central federal government. australia had reported confirmed cases on march when it imposed a closure of its borders to non-australian citizens, which was augmented by a mandatory -day, supervised quarantine in a hotel for all international arrivals (including australian citizens), aggressive testing and contact tracing, and population-wide adherence to social distancing guidelines [ ] . following these local containment measures australia saw no explosive covid- case surges through the southern hemisphere winter. despite a recent burst of domestic transmission in the state of victoria that resulted in the immediate re-imposition of a statewide lockdown and interstate movement restrictions [ ] , at present (early september ) australia reports . deaths/million persons, in comparison with the us report of deaths/million persons [ ] . this is the difference between establishing effective national border policies and failing to do so. the pandemic has presented different risks and rates of exposure to different sectors of us society, at different times and in different places. health care and other essential workers who continued to work while much of the country was shut down, who work in close quarters or have contact with the public as part of their job-e.g., in transportation, critical manufacturing, food and agriculture, grocery stores, and pharmacies-have faced a greater risk of exposure and infection from covid- . [ ] [ ] [ ] [ ] [ ] . despite the designation of these workers as "essential," an important federal failure has been the lack of standards requiring systematic collection of data on covid- cases or deaths by industry and occupation. nevertheless, information available from case reports, state health departments, media reports, and other sources show: large numbers of cases among health care workers and first responders; major outbreaks in meatpacking, and poultry plants [ ] ; outbreaks among prison staff (above and beyond inmates); and numerous cases in transportation, warehousing, and other essential industries, as well as in public-facing occupations (e.g., grocery stores and retail) [ ] . people infected at work expose their household members-and if they are low-wage workers, they are more likely to live in crowded housing with inadequate ventilation, which increases the risk of transmission and decreases the options for people who are ill to self-isolate [ , , [ ] [ ] [ ] . the federal government could have limited transmission of sars-cov- at the workplace in multiple ways. one is through its unparalleled purchasing power and ability to invoke the defense production act and ensure equitable supply and distribution of ppe. however supplying ppe was delegated to a variety of actors: state and city governments, large hospital chains, and in some cases small networks of clinics [ ] . second, the federal government could have established mandatory universal paid sick leave for those unable to work due to covid- , but it did not. the congressional mandate for h of paid covid-related leave covered only some groups of workers. third, the federal government could have mandated standards for occupational exposures, but it failed to act, even as some us states have done so. to date, the federal occupational safety and health administration (osha) has not issued any emergency or permanent standard specific to covid- exposure at the workplace; additionally, as of august , , federal osha, which oversees enforcement of osha standards in states, had issued only four citations related to covid- [ ] . moreover, the total number of federal osha inspections (of any kind) during has been reduced by twothirds, compared to the same period in prior years [ ] . several of the states with approved state osha plans have taken stronger regulatory and enforcement action than federal osha to protect workers from exposure to sars-cov- . for example, virginia issued a comprehensive emergency temporary standard on sars-cov- on july , , and the state of michigan has issued multiple executive orders on worker protection from covid- enforced through the michigan state osha plan [ , ] . the california, nevada, and minnesota state osha plans have all issued numerous citations under other existing standards to protect workers from covid- [ ] . however, in most states little regulatory or enforcement action has been taken by either the federal government or the state to address workplace exposures to the virus [ , ] . while there have been few federal osha citations, worker complaints to osha that raise concerns about workplace conditions and exposure to covid- can serve to estimate hazards of exposures and risks of infection as reported by workers themselves. to our knowledge, these data have not been analyzed in relation to the population burdens of covid- [ ] . figure shows the volume of osha complaints (federal and state combined), broken down by four industries (manufacturing, retail, healthcare and social assistance, and other up to september th ). the total number of national complaints is shown, as are the numbers of complaints for the four main geographical regions of the country. covid- mortality data from confirmed cases is also shown. figure in turn presents results of the time-series analysis using osha complaints volume, as a function of time, as a predictor and confirmed covid- cases and covid- deaths as the response variables. specifically, we identified the best time lag that predicts each response variable-using osha complaints as a predictor-by calculating the pearson correlation between multiple lags for each response variable and osha complaints. two findings stand out: ( ) the curve of the osha complaint data resembles an epidemic curve (fig. ) , and ( ) the complaints predate covid- deaths (fig. ) . at the national level, the osha complaints were best correlated with (a) covid- deaths days later ( = . ), and (b) covid- new confirmed cases days later ( = . ). across all four subregions-northeast, south, midwest, west-of the country, osha complaints foreshadowed covid- deaths by . - weeks, with moderate to high correlations ( . to . ). correlations with cases, however, are notably weaker in regions other than the north-east, which may be unsurprising given the volume of cases there in the spring. in general the variation in rates by geographic region and industry is substantial and mirrors the course of the pandemic-notably when considering individual industries the strongest correlation observed was between complaints in the health care and social assistance sector and deaths days later ( = . ) . regional correlations between complaints and reported covid- cases and covid- deaths (fig. ) suggest complaints reflect local responses to awareness of pandemic activity. these patterns point to a lack of learning from experiences across states, and the lack of enforced federal standards. according to osha covid- enforcement data, as of september , , federal osha had opened inspections for only out of worker complaints ( . %) received related to covid- [ , ] . during this same time period, the state osha plans had opened inspections in response to , covid- complaints received- . % of worker complaints for covid- [ , ] . these results further suggest that osha complaints have the potential to be used, in a prospective manner, to predict changes of covid- activity as an additional data source in early warning systems such as those as described in [ ] . we cannot determine the extent to which patterns of osha complaints reflect growing awareness of the pandemic and the need for adequate protection, or whether they are more direct indicators of failures that causally contributed to workplace, family, and community spread. but findings do suggest that expressed worker concerns may be an indicator of real risks, and failure to respond is a missed opportunity to intervene to mitigate disease transmission in the workplace and, in turn, the community at large. while there is not a consistent definition of "essential workers," data suggest that people in this category disproportionately are low-income, are people of color, rely on public transportation, and live in crowded housing [ , , [ ] [ ] [ ] . they also have more underlying disabilities and less access to care, which underscores the importance of mitigating exposures to sars-cov- in the workplace. work is a key exposure risk, and to date, federal policies regarding covid- and workplaces have chiefly aimed to limit the liability of employers, rather than to protect employees through, for example, mandating that employers develop an infection control plan [ ] . in the following section we consider the consequences in terms of excess all-cause mortality and racial/ethnic inequities in covid- mortality. beyond the number of confirmed covid- deaths in the us (more than , as of / / , estimates of excess deaths (comparing the same calendar period for to the average annual deaths for - and controlling for population growth) provide a powerful way to gauge the excess mortality due to covid- . excess mortality may be due directly to the infection or be due to delays in seeking care for non-covid illnesses or injuries; this measure also takes into account potential reductions in mortality (e.g., due to lower air pollution during the economic lockdown) as well as the seasonality of death rates [ ] [ ] [ ] . in table , we show the results of four different approaches, ranging from more to less conservative, that have been used to estimate the excess number of deaths and the excess death rate (per , person-years (p-y)), in relation to us mortality data as of september , [ ] [ ] [ ] [ ] . no matter which method is used, the estimated excess number of deaths, ranging from , to , , is already greater than the outer margin of what the federal government stated, on april , , would be the upper limit of the expected death toll, i.e., , [ ] [ ] [ ] . we additionally estimated an annual excess age-standardized death rate of . per , p-y ( % ci . - . ) based on the difference in age-standardized mortality rates for vs - , (as opposed to scaling the estimated excess death count by the population as in table ). this estimate is almost double that of the third leading cause of death in the us, i.e., unintentional injuries, for which the annual age-standardized death rate was / , p-y in (the most recent year available) [ ] . the number of excess deaths in ( , ) is already well over half the number of cancer deaths for all of ( , ) [ ] . it should be obvious that given that the pandemic is not over, and transmission continues in much of the country, these numbers can only increase. australia is again instructive, as it exhibits very little excess mortality. the most recent report from the australian bureau of statistics states, " , doctor certified deaths occurred between january and may and were registered by june. this compares to a baseline average of , over the past years" [ ] . this translates to an excess of only deaths in australia. in contrast, the us, with a population times greater, has times more excess deaths. if the us has struggled with national pandemic response, it is instructive to compare with europe. like the us, european nations are advanced economies with substantial resources. unlike the us, they are themselves independent nation states, with no overarching federal coordination, and the continent is far more densely populated than the us and has an older population. some european nations have suffered even higher per-capita mortality from the pandemic so far than the us, among them italy and spain (hit hard early in the spring) and the united kingdom. in contrast others such as germany (like the us a federal nation with extensive porous land borders) have far less covid- related mortality, and relatively little excess mortality overall including in the most at-risk age groups [ , ] . in contrast with the us, european nations have seen few subsequent surges over the summer after initial introductions were controlled, even if cases are increasing once more in many countries. however, the overall all-cause mortality for the continent as a whole through the end of july, when outbreaks were still ongoing across the south of the us, is estimated to be % lower than the us [ ] . we must also consider outcomes other than death. while sars-cov- is a virus that spreads via the respiratory route, it causes a systemic infection with commensurate potential for diverse long term sequelae, including important outcomes such as stroke in young, otherwise healthy adults [ ] , and multisystem inflammatory syndrome in children (mis-c), a condition similar to kawasaki syndrome that is associated with pediatric sars-cov- infection [ ] . if an extremely large number of infections are permitted, even rare chronic outcomes will leave a large burden on healthcare after the pandemic. as of august , , the number of confirmed cases in the us equaled . million-almost on par with the population of massachusetts ( . million) [ ] . [ ] . if % of the million cases were so afflicted, the number of persons ( , ) would exceed the national estimate for the number of us women diagnosed with breast cancer ( , ) [ ] . the proportion of long-term effects of one kind or another is unknown, but it is increasingly recognized as a source of serious concern [ , ] . finally, despite the initial federal failure to report covid- data by race/ethnicity [ ] , a combination of specific studies, state reporting, investigative journalism, and data trackers has revealed that a persistent feature of the pandemic has been the existence of racial/ethnic inequities in cases, hospitalizations, and mortality, especially with regard to increased risk among us black, latinx, and american indian/alaska native populations compared to the us white non-hispanic population [ - , , , , ] . what is less appreciated is that racial/ethnic inequities in covid- mortality rates, especially among younger working-age adults, are increasing over time, especially among the latinx and american indian/alaska native populations. these table estimation of excess deaths during the us covid- pandemic, comparing weekly death counts to the corresponding average annual - deaths, using different methods a as of september , (source: centers for disease control and prevention) a method : sum up over weeks and then age-standardize using the direct method method : count only age strata and weeks where the excess is greater than zero, and set weeks where the excess in the age stratum is less than zero to zero method : we compare to the upper bound on the average deaths for - , but once again ignore weeks where the excess in the age stratum is less than zero b age-standardized excess rate per , person-years is computed based on dividing the age-specific excess count of deaths under the four methods by the age-specific population person-time (taking into account the age-specific population counts and the elapsed time since january , ), weighting by the year standard million, and summing over age categories c age-standardized cumulative incidence proportion per , population (i.e. a risk per capita) is computed based on dividing the age-specific excess count of deaths under the four methods by the age-specific population count in , weighting by the year standard million, and summing over age categories trends are evident in fig. , which we generated using cdc data for february through september th, (with . % of deaths assigned a race/ethnicity) [ , ] . specifically, the racial/ethnic inequity in age-standardized mortality rate ratios, compared to white non-hispanics, increased over time for the five calendar periods displayed (february -may , may -june , june -july , july -august , august -september , and september -september ) among working age adults (ages - ) who were categorized as black non-hispanic (p value for trend < . ), hispanic (p < . ), and american indian/alaska native (p < . ).the estimates we report, moreover, are likely to be conservative because classification of covid- deaths in part depends on testing, and inequities in access to testing, especially affecting low-income communities of color, would deflate their reported covid- mortality rates [ , ] . moreover, the elevated mortality risk on the order of -to tenfold among persons under age shown in fig. is unlikely to be explained by pre-existing co-morbidities, because the documented racial/ethnic mortality rate ratios for major chronic conditions (including cardiovascular disease, diabetes, and cancer) among adults under age are around twofold or less [ , , ] . in closing, we have documented key points at which the us federal government has failed to take the actions and collect the data needed to protect the us population from covid- and the attendant toll on population health and health inequities. despite the understandable dismay at the state of the pandemic in the united states, it is not too late to make a difference, and that difference starts with the implementation of apt policies. those policies are too numerous to list here but have been amply documented in publications from organizations such as the center for global development, which identified many of the relevant challenges early in the pandemic, stating in february: "there is an urgent but closing window to prepare for large-scale spread of the disease in the us and elsewhere. this paper recommends actions to address pressing gaps in us and global preparedness in the event that covid- cannot be contained and sustained human-to-human transmission occurs beyond china" [ ] . the national association of county and city health officials has made the urgency of maintaining health equity in an emergency preparedness plan, as have local health officials [ , ] . perhaps most poignantly, a "pandemic playbook" produced by the national security council in "repeatedly (advises) officials to question the numbers on viral spread, ensure appropriate diagnostic capacity and check on the us stockpile of emergency resources" [ ] . what we have seen is the consequence of not heeding that advice. all cases and deaths cannot be prevented-that clearly is not possible with a novel pandemic-but the evidence suggests that ineffective national policies and responses [ ] , especially as compared to those of other wealthy nations or compared to the intricate preparation and planning by previous administrations of both parties, have been driving the terrible toll of covid- and its inequities in the us. this country-and its political leaders, who bear responsibility-can and must do better. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or 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inequity of coronavirus variation in racial/ethnic disparities in covid- mortality by age in the united states: a cross-sectional study covid- ) by race and hispanic origin group and age huge hole' in covid- testing data makes it harder to study racial disparities disparities in covid- testing and positivity in new york city trends in premature deaths among adults in the united states and latin america vital signs: racial disparities in age-specific mortality among blacks or african-americans-united states expert recommendations for us and global preparedness for covid- developing emergency preparedness plans with a health equity focus. naccho voice (national association of county and city health officials) health equity, social justice and emergency preparedness and response. presentation by nyc health trump team failed to follow nsc's pandemic playbook publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we would like to thank ziba cranmer and gowtham asokan, with bu spark! (boston university, massachusetts), for their advice, early on, regarding accessing and exploring the osha complaint data. we would also like to thank lawson ung (hsph) for advice on the nature of the australian pandemic response. we would like to thank and acknowledge dr. mary t. bassett (director, françois-xavier bagnoud (fxb) center for health and human rights at harvard university and fxb professor of the practice of health and human rights, harvard t.h. chan school of public health) for her intellectual leadership for prior work, in which she involved nk and jtc, on the importance of analyzing age-specific racial/ethnic inequities in covid- mortality, and which has influenced the approach taken for this paper. we would also like to thank pamela waterman (hsph) for her influence on the paper's analytic orientation and also for her role in facilitating team meetings and communication. we have written permission to acknowledge all of the individuals listed. authors' contributions w.p. hanage co-conceptualized the paper, led its writing, and helped frame the analyses and interpret results. c. testa co-conceptualized the analyses, helped obtain the data and conducted the data analyses for the occupational health and health inequities sections, and contributed to manuscript preparation. j. chen co-conceptualized the analyses, helped obtain the data and helped oversee the data analyses and interpretation for the occupational and health inequities sections, and contributed to manuscript preparation. p. seminario, e. pechter, and l. davis led acquisition and interpretation of the osha complaint data, and contributed to manuscript preparation. m. santillana co-conceptualized and assisted with implementing the analyses and interpreting them and contributed to manuscript preparation. n. krieger initiated the paper, led assembling the team, contributed to framing the paper and drafting each section, and guided the data acquisition, data analyses, and data interpretation for the sections pertaining to occupational health and health inequities. all co-authors contributed to the final manuscript and approved its content before submission. key: cord- - sidqomd authors: fu, minghui; liu, chuanjiang; yang, mian title: effects of public health policies on the health status and medical service utilization of chinese internal migrants date: - - journal: nan doi: . /j.chieco. . sha: doc_id: cord_uid: sidqomd abstract this paper examines the effects of the “equalization program of basic public health and family planning services for migrants” (ehfpsm), a novel internal migrant-targeted public health policy, of china implemented in . by combining the individual-level data from the “china migrants dynamic survey” and city-level statistical data, we find that ehfpsm contributes to a . % statistically significant increase in the probability of electronic health records coverage and a . % increase in the probability of reimbursement in the last inpatient visit, as well as a . % decrease in the probability of one-year prevalence. the mechanism test shows that this program promotes the migrants' understanding of the policies and social insurance coverage to enhance their health status. ehfpsm brings about more significant decreases in disease prevalence for male and less-educated migrants, and higher reimbursement probability for urban hukou migrants. our paper facilitates better understanding of the role of public health policies in promoting the internal migrants' health from the perspective of china. health, which is a crucial part of human capital, may largely represent wealth especially for low socioeconomic status individuals (grossman, ) . public health policies may enhance the benefits from this human capital (li et al., ) . much of the economic literature about health polices has been focused on the impact of health policies on international migrants or rural residents, while the impact of public health policies on internal migrants in developing countries has been less understood, which in fact is extremely important for policy-makers in coping with decreasing population dividend and public health emergency, such as the covid- epidemic. this paper intends to evaluate the effects of a novel public health policy of china on the basic public health service coverage, health status and medical service utilizations of internal migrants in the destination cities. we evaluate how public health policies affect internal migrants from the perspective of a unique policy of china: the "equalization program of basic public health and family planning services for migrants" (ehfpsm), which was issued in the end of . forty prefecture-level cities are assigned as the pilot cities, and a series of free basic public health and family planning j o u r n a l p r e -p r o o f services are provided to the internal migrants. there are some advantages of using this program in our study. first, the program provides a unique quasi-natural experiment for this study to clearly identify the effect of ehfpsm. secondly, much of the previous research assesses the effect of medical insurances to reduce the burden of illness (qin, pan, & liu, ) , while we investigate the effect of public health services to promote and maintain the health status of migrants. besides, the combination of the individual-level "china migrants dynamic survey" (cmds) data and city-level statistical data facilitates a better understanding of the effects of public health policies on the health welfare of internal migrants, who have enormous difficulties in accessing to those services before the implementation of this program (gao, yang, & li, ; kinnan et al., ; meng, ) . extensive economic studies have been conducted about the impacts of public policies on the health of migrants in developed countries (hardy et al., ; hatzenbuehler et al., ; rhodes et al., ) . for example, perreira & pedroza ( ) summarized the literature concerning the influence of public policies on american immigrants' health and found that inclusive policies promote their health service coverage and adaptation to the united states, whereas exclusive policies have the opposite impacts. in contrast to many developed countries, where migrants have access to essential services such as basic healthcare and schooling with the same conditions as legal residents (pinotti, ) , china's internal migrants have a high transaction cost in access to basic public health services (di napoli, petrelli, rossi, mirisola, & rosano, ; hu, cook, & salazar, ; the lancet, ) . besides, because of the late implementation of migrant-targeted public health policies in china, little research attention has been paid to the impact of those policies on migrants, except for only one study of wang, cheng, & ni ( ) . they found a positive association between ehfpsm and medical service utilization but failed to tackle the endogeneity problem of migrants' selection of the destination cities. to sum up, there is still a lack of comprehensive studies of how public health policies influence the health status and health welfare of internal migrants, and the present study aims to fill this gap. in this study, based on the individual-level data from cmds and the city-level statistical data, we comprehensively evaluate the effects of ehfpsm implementation on the internal migrants' basic public health service coverage and health status, as well as the spillover effect on their medical service utilization during - by combining the methods of psm and did. the results show that ehfpsm significantly increases the basic public health service coverage and improves health status, as well promotes the medical service utilization of the migrants. we then investigate the underlying mechanisms and find that ehfpsm imposes its positive effect on migrants through strengthening their awareness of "electronic health records" (ehrs), "urban employee basic medical insurance" (uebmi) coverage and "work injury insurance" (wii) coverage. we further compare the equalization effect of ehfpsm between different subgroups and find that ehfpsm brings about more significant positive impacts on less-educated or male migrants in health status, and on the urban hukou migrants in medical service utilization. finally, several robustness checks are carried out. specifically, we conduct an additional control of "new rural cooperative medical insurance" (nrcmi) and city-level labor market conditions based on the sampling survey data from % china census in . the results strongly support a positive association between ehfpsm implementation and migrants' health status and health welfare. this study contributes to the literature in several aspects. first, to our knowledge, this is the first study to comprehensively examine the impact of a novel migrant-targeted public health policy on migrants' basic public health service coverage, health status, and medical service utilization in china, providing a valuable reference for future research on the welfares of china's internal migrants. second, this study improves the understanding of the role of public health policies, which protect and improve the health of people and their communities, in promoting the migrants' health welfare, while the existing research is mostly focused on medical policies. third, this study provides new evidence from the case study of china that policy cognition and social insurance coverage are the primary channels through which pub lic health policies impose their impacts on the migrants' health status and medical service utilization. we did not study the effect of ehfpsm on the utilization of basic public family planning services of migrants due to the limitation of data. the rural hukou migrants refer to those who hold a rural hukou and have flowed from agricultural to non-agricultural sectors. the urban hukou migrants are those who hold an urban hukou in towns or cities that they do not reside in. the rest of the paper is structured as follows: section introduces the institutional background of ehfpsm implementation; section describes the data and outlines the identification strategy utilized; section reports the empirical results and discussion; section shows the robustness test, and section offers the concluding remarks. china's primary health service system was initiated in the early s, which had substantially reduced the occurrence of communicable, maternal, and neonatal diseases throughout the s and s. moreover, it helped to advance the global primary health-care movement in enshrined in the declaration of alma-ata (li et al., ) . in the late s, china started its economic reform with obvious urban-biased policies. the rationing system guaranteed permanent jobs for urban hukou labors and provided urban residents with access to primary food, housing, and education, as well as healthcare, at quite low prices. in contrast to the large government expenditure for urban residents, expenditure for rural residents was much lower. for example, the number of hospital beds and medical staff for every , people in cities was . and . in the s, while it was merely . and . in rural areas (zhang & kanbur, ) . as a result, the medical and health welfare enjoyed by rural residents largely lagged behind those enjoyed by urban residents in the planned economy era. in the mid-to-late s, market-oriented reforms on medical and health service system were successfully introduced but the access to this system was weakened at the same time. the market-oriented reforms resulted in even larger differences between urban and rural areas in access to medical and health services. during the reform period, a large number of people lost their medical insurance with the collapse of both state-owned enterprises and the people's communes. for instance, medical insurance coverage in rural areas decreased from % in to % in (ramesh, wu, & he, ; yang et al., ) . in the following decades, china began to launch a series of insurance schemes, such as the uebmi, nrcmi, and "urban resident basic medical insurance" (urbmi) (zhou, chen, & chen, ) . these schemes, however, still paid little attention to the equalization of the access to medical and health care between rural and urban j o u r n a l p r e -p r o o f journal pre-proof residents (yang et al., ) . a new round of reform on medical and health service system emerged after the sars epidemic, and one of the key goals is the equalization of access to basic public health services between urban and rural residents. the "national basic public health service program" (nbphs) was issued by the "ministry of health" (moh) in to mainly provide free basic public health services for urban and rural residents through primary medical and health institutions. the government increased the subsidies for these institutions from billion yuan (us $ . billion) in to billion yuan ($ . billion) in (li et al., ) , making basic public health services more accessible to urban and rural residents. the migrants, however, have little access to these services neither in the destination cities under the restriction of the hukou system nor in their hometown due to long-term absence (liang, ) . worse still, allied health services, such as occupational disease prevention and control, were not integrated into the basic health service system, resulting in poor utilization of these services by the migrants (li et al., ) . according to the data from cmds , the proportions of migrants with pension insurance coverage, wii coverage, and unemployment insurance coverage in beijing are about half of those of the native residents of the same age. specifically, unified and standardized ehrs (i.e. essential information, major health problems and health service records) are established for the migrants who have lived in the pilot cities for no less the key projects of nbphs are as follows: ( ) establishment of ehrs; ( ) health education; ( ) p reventive vaccination; ( ) prevention and control of infectious diseases; ( ) child health care; ( ) maternal health care; ( ) elderly health care; ( ) chronic disease management; and ( ) severe mental illness management. ehfpsm is an important development of nbphs to improve the access of migrant groups to public health and family planning services that are not fully covered by the previous programs. besides, based on the features and specific needs of the migrants, ehfpsm attaches great importance to the measures such as establishment of ehrs, health education, care for pregnant/lying-in women and children, planned immunization, family planning, prevention and control of infectious diseases. table demonstrates a comprehensive comparison o f nrcmi, nbphs and ehfpsm. comparison among nrcmi, nbphs and ehfpsm. methodology and data . the impacts of ehfpsm implementation on the migrants' basic public health service coverage, health status and medical service utilization can be evaluated according to the differences in health outcomes between the migrants in the pilot cities (treated group) and those who are supposed to be not in these pilot cities (counterfactual control group). since the health outcomes of the latter samples could not be directly observed, we obtain them from the non-pilot cities under a random assignment. although ehfpsm implementation is considered as exogenous, it can be expected that there may be systematic differences between migrants in pilot and non-pilot cities because of the non-random destination selection of the sample. besides, the sample grouping methods of psm can better mitigate this self-selection bias (perreira & pedroza, ) . first, the psm technique is utilized to obtain the matched control group with obse rvable j o u r n a l p r e -p r o o f characteristics. in the empirical analysis, we employ a logit regression to estimate the selection model of flow destinations as eq. ( ). the dependent variable is a dummy variable for whether migrant has flowed into the pilot city. the covariates include individual-level pre-determined variables and the city-level indicators measured at the pre-treatment period. prob(treated = ) = g(city economic vars ( − ) ,individual vars ) ( ) subsequently, the did method was employed to identify the impact of the ehfpsm. after obtaining a matched control group with the technique of psm, the impact of ehfpsm on migrants could be empirically studied by the following model shown as eq. ( ): in the equation, the outcome variables (outcome ) include dummies for basic public health service coverage, health status, and medical service utilization of migrant in city of province at year . the term denotes the dummy for whether city c into which migrant flows is one of the pilot cities of ehfpsm. the covariates include individual-level, household-level and city-level controls discussed below, province fixed effects and year fixed effects. the coefficient captures the short-term effects of ehfpsm implementation on internal migrants, and the estimation is based on the differences in before-after changes of outcomes between the treated group and the matched control group simultaneously. all the standard errors are clustered at the city level. the data of cmds in and provide substantial items for this research. the dependent variables include three types of indicators: ( ) the basic public health service coverage, which is measured as ehrs coverage, is a dummy for whether ehrs in the destination cities are established ( = yes, = no); ( ) health status, which is represented by the one-year prevalence, is a dummy for whether the migrants have suffered from prevalence (injury) or physical discomfort in the last year ( = yes, = no), which is a negative indicator of health; and ( ) medical service utilization, which is measured as the reimbursement in last inpatient visit, is a dummy for whether the medical expense for the last inpatient visit has been reimbursed ( = yes, = no). we propose the following three hypotheses for the impacts of ehfpsm implementation on internal migrants. ( ) ehfpsm has a positive effect on the probability of ehrs coverage ( = yes) for migrants because it is the major goal. ( ) ehfpsm has a negative impact on the probability of the migrants' prevalence in last year ( = yes), because it is also one major goal of the program. ( ) ehfpsm has a positive effect on the reimbursement of the last inpatient visit ( = yes), which is a spillover effect because ehfpsm enhances the migrants better utilize the medical service when they have an inpatient visit, instead of directly providing reimbursement for them. the potential channels are as follows: ( ) policy cognition channel, which is measured as the awareness of ehrs, a dummy for whether the migrants have heard of the ehrs in the destination cities ( = yes, = no); ( ) medical insurance channel, which is represented by uebmi coverage, a dummy for whether the migrants have an uebmi ( = yes, = no); and ( ) wii channel, which is measured as wii coverage, a dummy for whether the migrants have a wii ( = yes, = no). we control a variety of variables to mitigate the possib le spurious correlation as follows. the individual-level variables include age, the square of age, and dummies for gender, han nationality, education, and married. the household-level variables comprise household scale and household income per capita in the cities. the logarithm form of household income per capita is taken. the city-level variables include gdp per capita and population density, all of which are taken with logarithm form; besides, the location fixed effects of residing province are included. the we combine the statistical data of prefecture-level cities with migrants' individuallevel data. to be more precise, we limit the living time of the migrants in the destination cities to no less than six months. then, to reduce the possible influence of unobservable factors arising from the difference between cities, only the cities appeared in both and survey are chosen as the sample cities. besides, abnormal samples are excluded by discarding the individual samples with income lower than the st percentile or higher than the th percentile. ultimately, the sample size in this study is approximately , migrants, covering prefecture-level cities (more than % of china's prefecture-level cities). overall, the treated samples tend to have an urban hukou, to be male, to be younger, to be married, and to have a relatively higher level of education compared with the control groups. besides, the basic public health service coverage, health status, and medical service utilization (represented by ehrs coverage, one-year prevalence and reimbursement in the last inpatient visit) of the control groups and treated groups have been improved substantially, particularly those of the treated group. for example, the ratio of reimbursement in the last inpatient visit of the treated group increases from . % in to . % in , and that of the control group rises from . % to % as well. another example is the ehrs coverage. the ratio of ehrs coverage of the treated group increases from . % to . %, while that of the control group shows a decreasing trend. contrarily to the latter, the awareness ratio of ehrs of the control group increases from . % to . %. considering the difference in sample scale between and , the endogeneity of self-selection should be tackled before estimation. empirical results and discussion . in this part, referring to dai & wang ( ) and ma & nolan ( ) , we employ the psm technique to obtain the matched control group by observable characteristics. we first estimate the propensity score, that is, the probability of the flow of the migrants to the pilot cities, with a logit model shown as eq. ( ). the dependent variable of "treated" is a dummy for whether a migrant has been in the pilot city. the observable pre-determined characteristics include individual characteristics, as well as the city-level population density measured at the pre-treatment period and the fixed effects of the home province and residing province. then, we obtain the matched control group by matching the treated group and control groups based on the propensity score. a one-to-one matching technique without replacement is employed for the nearest-neighbor psm and mdm algorithm. to satisfy the common support condition (csc), we exclude the treated samples whose propensity scores are higher than the maximum or lower than the minimum propensity score of the potential control group. to assess the matching quality, we compare the treated group and the control group before and after the matching. table a shows the balance test of the covariates before and after psm. the standardized biases are largely reduced, and all of the selection bias is lower than %, suggesting that the selection biases are effectively eliminated by the matching (dai & wang, ) . besides, fig. shows that the matching removes the significant differences in the kernel density of the propensity scores between the treated group and unmatched control group. overall, the matching procedure is valid and covariates of the treated group and the matched control group balance. table presents the effects of ehfpsm on migrants' basic public health service coverage, health status and medical service utilization, and is the estimation results of eq. ( ) by the logit model with psm and did method. columns ( ), ( ) and ( ) control the province fixed effect, and columns ( ), ( ) and ( ) control the individual characteristics, household characteristics, city characteristics, and province fixed effect. we first investigate the associations of ehfpsm with the migrants' basic public health service coverage as well as their health status. the dependent variable (ehrs coverage) of columns ( ) - ( ) in table is a dummy for whether ehrs has been established for a migrant. the results show that the ehfpsm has significantly increased the probability of ehrs coverage, and significantly improved the migrants' access to basic public health service. besides, dependent variable (one-year prevalence) of columns ( ) -( ) is a negative indicator of health status. the results show that the policy has significantly decreased the probability of migrants' one-year prevalence. we further examine the spillover effect of ehfpsm on medical service utilization of migrants in columns ( )-( ). as mentioned in the hypotheses in section . , ehfpsm does not directly provide any reimbursement for migrants. in facts, it promotes the migrants to take better advantages of medical service policies for reimbursement when they have an inpatient visit. the policy has significantly increased the probability of reimbursement in the last inpatient visit, as well as improved the medical service utilization of the migrants. effects of ehfpsm on the basic public health service coverage, health status and medical service utilization of internal migrants. one ( ) ***, **, * denote the %, % and % significance levels, respectively. since the coefficients in table cannot directly reveal the magnitude of the effect of ehfpsm on migrants, we then report their marginal effects in table . all the empirical specifications in table are consistent with those in table . column ( ) shows that when the values of the control variables are kept unchanged, ehfpsm significantly increases the probability of ehrs coverage by . %. column ( ) reports that ehfpsm contributes to a . % reduction in the probability of the one-year prevalence. column ( ) demonstrates that ehfpsm contributes to a . % increase in the probability of reimbursement in the last inpatient visit of internal migrants. note: ( ) the dependent variables of "ehrs coverage", "one-year prevalence", and "reimbursement in last inpatient vis it" are dummies ( = yes, = no). ( ) the table reports the marginal effects of logit regressions. ( ) standard errors are corrected for clustering at the city level and displayed in parentheses below all coefficients. ( ) ***, **, * denote the %, % and % significance levels, respectively. in this subsection, we examine three important underlying channels through which ehfpsm affects internal migrants' basic public health service coverage, health status and medical service utilization. we assume that ehfpsm strengthens the migrants' awareness of ehrs, as well as increases their uebmi coverage and wii coverage. we employ the psm-did method to test the underlying mechanisms. definitions and measurements of the three channel indicators are shown in section . . ( ) ( ) ehfpsm promotes the migrants to contact with the providers, which in turn increases the medical service utilization of migrants. underlying channels for the effects of ehfpsm on internal migrants: marginal effect. note: ( ) the dependent variables of "awareness of ehrs", "uebmi coverage", and "wii coverage" are dummies ( = yes, = no). ( ) the table reports the marginal effects of logit regressions. ( ) standard errors are corrected for clustering at the city level and displayed in parentheses below all coefficients. ( ) ***, **, * denote the %, % and % significance levels, respectively. columns ( )-( ) in table show that both uebmi coverage and wii coverage are the social insurance channels for ehfpsm to affect the migrants' welfare. the coefficient of the interaction term in column ( ) is positive and statistically significant, suggesting that ehfpsm has increased the uebmi coverage by . %. column ( ) shows that ehfpsm has increased the migrants' wii coverage by %. these mechanisms bring about positive effects in two aspects: ( ) ehfpsm prompts the migrants to participate in normal labor markets and further facilit ates their better utilization of medical service; ( ) ehfpsm promotes the social integration of the migrants into the destination cities and then improves their health status. we have previously provided the estimation results of the impact of ehfpsm on basic public health service coverage, health status and medical service utilization of migrants. however, it remains unclear whether there are any differences in the impact of ehfpsm on different subgroups. answering this question may help to understand the equalization effect of ehfpsm. we further explored the heterogeneous effect of ehfpsm implementation on different subgroups, and the results are shown as marginal effects. table reports the heterogeneous effects of ehfpsm in terms of individual hukou, education level, and gender. compared with their counterparts, migrants who are less-educated or male suffer less from one-year prevalence, and urban hukou migrants receive a higher probability of reimbursement. in column ( ), the coefficient of our interested interaction term is ne gative. the result reveals that the effect of ehfpsm on the ehrs coverage of urban hukou migrants is not more significant in magnitude than that of rural hukou migrants. one possibility is that neither the urban hukou migrants nor the rural hukou migrants can take the medical insurance with them to the destination cities (cheng, nielsen, & smyth, ) . besides, in column ( )-( ), the coefficients of our interested interaction terms are insignificant. columns ( )-( ) show the heterogeneous effects of ehfpsm on one-year prevalence of subgroups. the coefficient of the interaction term in column ( ) is insignificant, while that in column ( ) is positive and statistically significant, revealing that ehfpsm has significantly reduced the probability of one-year prevalence for less-education migrants by %, and decreased that for j o u r n a l p r e -p r o o f high-education migrants by . % (= - . + . ). the coefficient of the interaction term in column ( ) is negative and statistically significant, suggesting that ehfpsm has a more significant reduction effect on the probability of one-year prevalence for male migrants than that for female migrants. columns ( )- ( ) show the heterogeneous effects of ehfpsm on medical service utilization of different subgroups. in column ( ), the coefficient of the interaction term is positive and statistically significant. the result suggests that ehfpsm has increased the probability of reimbursement in the last inpatient visit for rural hukou migrants by . %, and more significantly enhanced that for urban hukou migrants by . % (= . + . ). besides, in column ( )-( ), the coefficients of our interested interaction terms are insignificant. note: ( ) the dependent variables are dummies ( = yes, = no). ( ) the table reports the marginal effects of logit regressions. ( ) "edu" is measured as a dummy ( = high-education , = low-education), where "low-education" migrants represent those with a junior high school education or below, and "high-education" migrants represent those with a senior high school education or above. ( ) standard errors are corrected for j o u r n a l p r e -p r o o f journal pre-proof clustering at the city level and displayed in parentheses. ( ) ***, **, * denote the %, % and % signific ance levels, respectively. to clarify whether the improvement of migrants' health status and medical service utilization is associated with other social security programs (such as nrcmi) or city-level labor market conditions, we control the effects of these social security programs and then check the robustness. following the previous research (du, xu, & wu, ) , we employ the sampling survey data from % china census in to construct the indicators of labor market conditions in the pre-treatment period: "city-level pension insurance ratio" and "citylevel medical insurance ratio". in general, higher values of these indicators represent higher standardization degrees of the labor market. first, we control the potential confounders of nrcmi in columns ( )-( ) of table . column second, we control the confounders of city-level labor market conditions, and the results are shown in columns ( )-( ) of table . column ( ) shows that ehfpsm increases the odds of ehrs coverage by . % (= ( . ) − ). besides, the coefficient of "city-level medical insurance ratio" is positive and statistically significant, suggesting that higher labor market standardization means a higher average ratio of ehrs coverage for migrants. column ( ) demonstrates that ehfpsm reduces the odds of one-year prevalence, while the coefficients of city-level labor market conditions are insignificant. column ( ) demonstrates that ehfpsm enhances the probability of reimbursement in the last inpatient visit. to sum up, when controlling the nrcmi and city-level labor market conditions, the results in table are consistent with those in table . to address the concerns about measurement errors of variables, some robustness checks are carried out by replacing the dependent variables with broad definition of ehrs coverage, broad definition of awareness of ehrs, and whether having a child born in the destination city (only for married samples). table shows the robustness test results of replacement of dependent variables. columns ( )-( ) show that the coefficients of key interests are similar in magnitude to those in j o u r n a l p r e -p r o o f we examine the robustness of psm by employing different matching techniques. first, propensity score is estimated according to eq. ( ), and both matching methods of radius and kernel are utilized to obtain the treated group and the matched control group, respectively. then, we estimate the effects of ehfpsm on the migrants' basic public health service coverage, health status, and medical service utilization by did regressions. overall, table shows that the coefficients are still significant and robust by combining different psm techniques and did. ( ) ***, **, * denote the %, % and % significance levels, respectively. ehfpsm is a novel public health policy to improve access to basic public health and family planning services of internal migrants in china. however, research on the effects of the program and the potential mechanism is rather limited. with growing global connections and increasing concerns about public health emergencies, the health of migrants have received great attention. hence, a comprehensive evaluation of the effect of ehfpsm provides important implications for policy designers to improve the health status and social integration of the migrants in developing countries. this study provides a comprehensive evaluation of the effects of the ehfpsm on internal migrants' basic public health service coverage, health status and medical service utilization based on cmds data and city-level statistic indicators. by combining the psm-did method and controlling for a variety of individual, household and city characteristics, we provide robust evidence that ehfpsm significantly increases the probability of electronic resident health records (ehrs) coverage by . %, and decreases the probability of one-year prevalence by . %. the spillover effect demonstrates that ehfpsm is associated with a . % increase in the probability of reimbursement in the last inpatient visit. furthermore, ehfpsm imposes its positive impacts on the health status and welfare of migrants through strengthening the awareness of ehrs, uebmi coverage and wii coverage. finally, ehfpsm brings about more significant decreases in disease prevalence for male and less-educated migrants, and higher reimbursement probability for urban hukou migrants. overall, three policy implications may be proposed from this study. ( ) the policy design j o u r n a l p r e -p r o o f should focus not only on soft goals such as improving the basic public health service coverage of the migrants, but also on more critical goals such as promoting health equity for them. ( ) health education should be strengthened to improve the migrants' health literacy, such as how to make proper utilization of social security policies to protect themselves. ( ) more importance should be attached to the welfare improvement of vulnerable groups, such as rural and female migrants, to promote their equal access to basic public health service. note: the dependent variable is "treated" (dummy for whether the migrant is in one of the pilot cities). the results of home and resident provinces dummies are not reported in the table, and the information is available on request. direct and spillover effects of middle school vaccination requirements access to social insurance in urban china: a comparative study of rural-urban and urban-urban migrants in beijing does the high-and new-technology enterprise program promote innovative performance ? evidence from chinese firms access to medical examination for primary prevention among migrants labor protection and welfare improvement for rural migrant workers: the new labor contract law perspective labor contracts and social insurance participation among migrant workers in china a call for further research on the impact of state-level immigration policies on public health immigration policies and mental health morbidity among latinos: a state-level analysis internal migration and health in china the effects of social ties on rural-urban migrants' intention to settle in cities in china access to migration for rural households the primary health-care system in china china's great migration and the prospects of a more integrated society language barriers and health status of elderly migrants: micro-evidence from china public healthcare entitlements and healthcare utilisation among the older population in ireland labor market outcomes and reforms in china the demand for health: a theoretical and empirical investigation policies of exclusion: implications for the health of immigrants and their children clicking on heaven's door: the effect of immigrant legalization on crime does participating in health insurance benefit the migrant workers in china? an empirical investigation health governance and healthcare reforms in china the impact of local immigration enforcement policies on the health of immigrant hispanics/latinos in the united states caring for migrant health-care workers can the policy of equalization of basic public services for health and family planning improve the utilization of medical services by migrant population the tsinghua-lancet commission on healthy cities in china: unlocking the power of cities for a healthy china spatial inequality in education and health care in china equity in health-care financing in china during the progression toward j o u r n a l p r e -p r o o f journal pre-proof universal health coverage population density(t- ) (log) (city level) • evaluating the effects of ehfpsm, a novel migrant-targeted public health policy in china, on the health welfare and health status of internal migrants.• psm and did are combined to tackle the problems of sample self-selection and endogeneity.• ehfpsm has significantly improved the health basic public service coverage and health status of internal migrants.• ehfpsm has a spillover effect on the medical service utilization of internal migrants.• ehfpsm imposes its positive impacts on the health status and welfare of migrants through strengthening the awareness of ehrs, uebmi coverage and wii coverage.j o u r n a l p r e -p r o o f key: cord- -ikepr p authors: tulchinsky, theodore h.; varavikova, elena a. title: expanding the concept of public health date: - - journal: the new public health doi: . /b - - - - . - sha: doc_id: cord_uid: ikepr p ancient societies recognized the needs of sanitation, food safety, workers’ health, and medical care to protect against disease and to promote well-being and civic prosperity. new energies and knowledge since the eighteenth century produced landmark discoveries such as prevention of scurvy and vaccination against smallpox. the biological germ theory and competing miasma theory each proved effective in sanitation, and immunization in control of infectious diseases. non-communicable diseases as the leading causes of mortality have responded to innovative preventive care of health risk factors, smoking, hypertension, obesity, physical inactivity, unhealthful diets, and diabetes mellitus. health promotion proved effective to modern public health in tackling disease origins, individual behavior, and social and economic conditions. the global burden of infectious and non-communicable diseases, aging and chronic illness faces rising costs and still inadequate prevention. the evolution of concepts of public health will have to address these new challenges of population health. the development of public health from its ancient and recent roots, especially in the past several centuries, is a continuing process, with evolutionary and sometimes dramatic leaps forward, and important continuing and new challenges for personal and population health and well-being. everything in the new public health is about preventing avoidable disease, injuries, disabilities, and death while promoting and maximizing a healthy environment and optimal conditions for current and future generations. thus, the new public health addresses overall health policy, resource allocation, as well as the organization, management, and provision of medical care and of health systems in general within a framework of overall social policy and in a community, state, national, transnational, and global context. the study of history (see chapter ) helps us to understand the process of change, to define where we came from and where we are going. it is vital to recognize and understand change in order to deal with radical transformations in direction that occur as a result of changing demography and epidemiology, new science, evolving best practices in public health and clinical medicine, and above all inequalities in health resulting from societal system failures and social and economic factors. health needs will continue to develop in the context of environmental, demographic and societal adjustments, with knowledge gained from social and physical sciences, practice, and economics. for the coming generations, this is about not only the quality of life, but the survival of society itself. over the past century there have been many definitions of public health and health for all. mostly they represent visions and ideals of societal and global aspirations. this chapter examines the very base of the new public health, which encompasses the classic issues of public health with recognition of the advances made in health promotion and the management of health care systems as integral components of societal efforts to improve the health of populations and of individuals. what follows in succeeding chapters will address the major concepts leading to modern and comprehensive elements of public health. inevitably, concepts of public health continue to evolve and to develop both as a philosophy and as a structured discipline. as a professional field, public health requires specialists trained with knowledge and appreciation of its evolution, scientific advances, concepts, and best practices, old and modern. it demands sophisticated professional and managerial skills, the ability to address a problem, reasoning to define the issues, and to advocate, initiate, develop, and implement new and revised programs. it calls for profoundly humanistic values and a sense of responsibility towards protecting and improving the health of communities and every individual. in the twenty-first century, this set of values was well expressed in the human development index agreed to by nations (box . ). public health is a multidimensional field and therefore multidisciplinary in its workforce and organizational needs. it is based on scientific advances and application of best practices as they evolve, and includes many concepts, including holistic health, first established in ancient times. the discussion will return to the diversity of public health throughout this chapter and book many times. in previous centuries, public health was seen primarily as a discipline which studies and implements measures for control of communicable diseases, primarily by sanitation and vaccination. the sanitary revolution, which preceded the development of modern bacteriology, made an enormous contribution to improved health, but many other societal factors including improved nutrition, education, and housing were no less important for population health. maternal and child health, occupational health, and many other aspects of a growing public health network of activities played important roles, as have the physical and social environment and personal habits of living in determining health status. in recent decades recognition of the importance of women's health and health inequalities associated with many high-risk groups in the population have seen both successes and failures in addressing their challenges. male health issues have received less attention, apart from issues associated with specific diseases, or those of healthy military personnel. the scope of public health has changed along with growth of the medical, social, and public health sciences, public expectations, and practical experience. taken together, these have all contributed to changes in the concepts and causes of disease. health systems that fail to adjust to changes in fundamental concepts of public health suffer from immense inequity and burdens of preventable disease, disability, and death. this chapter examines expanding concepts of public health, leading to the development of a new public health. public health has evolved as a multidisciplinary field that includes the use of basic and applied science, education, social sciences, economics, management, and communication skills to promote the welfare of the individual and the community. it is greater than the sum of its component elements and includes the art and politics of the funding and coordination of the wide diversity of community and individual health services. the concept of the interdependence of health in body and in mind has ancient origins. they continue to be fundamental to individuals and societies, and part of the fundamental rights of all humans to have knowledge of healthful lifestyles and to have access to those measures of good health that society alone is able to provide, such as immunization programs, food and drug safety and quality standards, environmental and occupational health, and universal access to high-quality primary and specialty medical and other vital health services. this holistic view of balance and equilibrium may be a renaissance of classical greek and biblical traditions, applied with the broad new knowledge and experience of public health and medical care of the nineteenth, twentieth, and the early years of the twenty-first centuries as change continues to challenge our capacity to adapt. the competing nineteenth-century germ and miasma theories of biological and environmental causation of illness each contributed to the development of sanitation, hygiene, immunization, and understanding of the biological and social determinants of disease and health. they come together in the twenty-first century encompassed in a holistic new public health addressing individual and population health needs. medicine and public health professionals both engage in organization and in direct care services. these all necessitate an understanding of the issues that are included in the new public health, how they evolved, interact, are put together in organizations, and are financed and operated in various parts of the world in order to understand changes going on before our eyes. great success has been achieved in reducing the burden of disease with tools and concepts currently at our disposal. the idea that this is an entitlement for everyone was articulated in the health for all concept of alma-ata in . the health promotion movement emerged in the s and showed dramatically effective results in managing the new human immunodeficiency virus (hiv) pandemic and in tackling smoking and other risk factors for non-communicable diseases (ncds). a health in all policy concept emerged in promoting the concept that health should be a basic component of all public and private policies to achieve the full potential of public health and eliminate inequalities associated with social and economic conditions. profound changes are taking place in the world population, and public health is crucial to respond accordingly: mass migration to the cities, fewer children, extended life expectancy, and the increase in the population of older people who are subject to more chronic diseases and disabilities in a changing physical, social, and economic climate. health systems are challenged with continuing development of new medical technologies and related reforms in clinical practice, while experiencing strong influences of pharmaceuticals and the medicalization of health, with prevention and health promotion less central in priorities and resource allocation. globalization of health has many meanings: international trade, improving global communications, and economic changes with increasing flows of goods, services, and people. ecological and climate change bring droughts, hurricanes, arctic meltdown, and rising sea levels. globalization also has political effects, with water and food shortages, terrorism, and economic distress affecting billions of people. in terms of health, disease can spread from one part of the world to others, as in pandemics or in a quiet spread such as that of west nile fever moving from its original middle eastern natural habitat to the americas and europe, or severe acute respiratory syndrome (sars), which spread with lightning speed from chinese villages to metropolitan cities such as toronto, canada. it can also mean that the ncds characteristic of the industrialized countries are now recognized as the leading causes of death in low-and middle-income countries, associated with diet, activity levels, and smoking, which are themselves pandemic risk factors. the potential for global action in health can also be dramatic. the eradication of smallpox was a stunning victory for public health. the campaign to eradicate poliomyelitis is succeeding even though the end-stage is fraught with setbacks, and measles elimination has turned out to be more of a challenge than was anticipated a decade ago, with resurgence in countries thought to have it under control. global health policies have also made the achievements of public-private partnerships of great importance, particularly in vaccination and acquired immunodeficiency syndrome (aids) control programs. there have been failures as well, with very limited progress in human resources development of the public health workforce in low-income countries. the new public health is necessarily comprehensive in scope and it will continue to evolve as new technologies and scientific discoveries -biological, genetic, and sociological -reveal more methods of disease control and health promotion. it relates to or encompasses all community and individual activities directed towards improving the environment for health, reducing factors that contribute to the burden of disease, and fostering those factors that relate directly to improved health. its programs range broadly from immunization, health promotion, and child care, to food labeling and fortification, as well as to the assurance of well-managed, accessible health care services. a strong public health system should have adequate preparedness for natural and human-made disasters, as seen in the recent tsunamis, hurricanes, biological or other attacks by terrorists, wars, conflicts, and genocidal terrorism (box . ) . the concepts of health promotion and disease prevention are essential and fundamental elements of the new public health. parallel scientific advances in molecular biology, genetics and pharmacogenomics, imaging, information technology, computerization, biotechnology, and nanotechnology hold great promise for improving the productivity of the health care system. advances in technology with more effective and less expensive drug and vaccine development, with improved safety and effectiveness, and fewer adverse reactions, will over time greatly increase efficiency in prevention and treatment modalities. the new public health is important as a conceptual base for training and practice of public health. it links classical topics of public health with adaptation in the organization and financing of personal health services. it involves a changed paradigm of public health to incorporate new advances in political, economic, and social sciences. failure at the political level to appreciate the role of public health in disease control holds back many societies in economic and social development. at the same time, organized public health systems need to work to reduce inequities between and inside countries to ensure equal access to care. it also demands special attention through health promotion activities of all kinds at national and local societal levels to provide access for groups with special risks and needs to medical and community health care with the currently available and newly developing knowledge and technologies. the great gap between available capabilities to prevent and treat disease and actually reaching all in need is still the the mission of the nph is to maximize human health and well-being for individuals and communities, nationally and globally. the methods with which the nph works to achieve this are in keeping with recognized international best practices and scientific advances: . societal commitment and sustained efforts to maximize quality of life and health, economic growth with equity for all (health for all and health in all). collaboration between international, national, state, and local health authorities working with public and private sectors to promote health awareness and activities essential for population health. . health promotion of knowledge, attitudes, and practices, including legislation and regulation to protect, maintain, and advance individual and community health. . universal access to services for prevention and treatment of illness and disability, and promotion of maximum rehabilitation. . environmental, biological, occupational, social, and economic factors that endanger health and human life, addressing: (a) physical and mental illness, diseases and infirmity, trauma and injuries (b) local and global sanitation and environmental ecology (c) healthful nutrition and food security including availability, quality, safety, access, and affordability of food products (d) disasters, natural and human-made, including war, terrorism, and genocide (e) population groups at special risk and with specific health needs. . promoting links between health protection and personal health services through health policies and health systems management, recognizing economic and quality standards of medical, hospital, and other professional care in health of individuals and populations. . training of professional public health workforces and education of all health workers in the principles of ethical best practices of public health and health systems. . research and promotion of current best practices: wide application of current international best practices and standards. . mobilizing the best available evidence from local and international scientific and epidemiological studies and best practices recognized as contributing to the overall goal. . maintaining and promoting equity for individual and community rights to health with high professional and ethical standards. source of great international and internal national inequities. these inequities exist not only between developed and developing countries, but also within transition countries, mid-level developing countries, and those newly emerging with rapid economic development. the historical experience of public health will help to develop the applications of existing and new knowledge and societal commitment to social solidarity in implementation of the new discoveries for every member of the society, despite socioeconomic, ethnic, or other differences. political will and leadership in health, adequate financing, and organization systems in the health setting are crucial to furthering health as an objective with defined targets, supported by well-trained staff for planning, management, and monitoring the population health and functioning of health systems. political leadership and professional support are both indispensable in a world of limited resources, with high public expectations and the growing possibilities of effectiveness of public health programs. well-developed information and knowledge management systems are required to provide the feedback and information needed for good management. it includes responsibilities and coordination at all levels of government. non-governmental organizations (ngos) and participation of a well-informed media and strong professional and consumer organizations also have significant roles in furthering population health. no less important are clear designations of responsibilities of the individual for his or her own health, and of the provider of care for humane, high-quality professional care. the complexities and interacting factors are suggested in figure . , with the classic host-agent-environment triad. many changes have signaled a need for transformation towards the new public health. religion, although still a major political and policy-making force in many countries, is no longer the central organizing power in most societies. organized societies have evolved from large extended families and tribes to rural societies, cities, regions, and national governments. with the growth of industrialized urban communities, rapid transport, and extensive trade and commerce in multinational economic systems, the health of individuals and communities has become more than just a personal, family, and/or local problem. an individual is not only a citizen of the village, city, or country in which he or she lives, but a citizen of a "global village". the agricultural revolutions and international explorations of the fifteenth to seventeenth centuries that increased food supply and diversity were followed only much later by knowledge of nutrition as a public health issue. the scientific revolution of the seventeenth to nineteenth centuries provided the basics to describe and analyze the spread of disease and the poisonous effects of the industrial revolution, including crowded living conditions and pollution of the environment with serious ecological damage. in the latter part of the twentieth century, a new agricultural "green revolution" had a great impact in reducing human deprivation internationally, yet the full benefits of healthier societies are yet to be realized in the large populations living in abject poverty in sub-saharan africa, south-east asia, and other parts of the world. global water shortages can be addressed with new methods of irrigation, water conservation and the application of genetic sciences to food production, and issues of economics and food security are of great importance to a still growing world population with limited supplies. further, food production capacity can and must be enlarged to meet current food insecurity, rising expectations of developing nations, and population growth. the sciences of agriculture-related fields, including genetic sciences and practical technology, will be vital to human progress in the coming decades. these and other societal changes discussed in chapter have enabled public health to expand its potential and horizons, while developing its pragmatic and scientific base. organized public health in the twentieth century proved effective in reducing the burden of infectious diseases and has contributed to improved quality of life and longevity by many years. in the last half-century, chronic diseases have become the primary causes of morbidity and mortality in the developed countries and increasingly in developing countries. growing scientific and epidemiological knowledge increases the capacity to deal with these diseases. many aspects of public health can only be influenced by the behavior of and risks to the health of individuals. these require interventions that are more complex and relate to societal, environmental, and community standards and expectations as much as to personal lifestyle. the dividing line between communicable and non-communicable diseases changes over time. scientific advances have shown the causation of chronic conditions by infectious agents and their prevention by curing the infection, as in helicobacter pylori and peptic ulcers, and in prevention of cancer of the liver and cervix by immunization for hepatitis b and human papillomavirus (hpv), respectively. chronic diseases have come to the center stage in the "epidemiological transition", as infectious diseases came under increasing control. this, in part, has created a need for reform in the funding and management of health systems due to rapidly rising costs, aging of the population, the rise of obesity and diabetes and other chronic conditions, mushrooming therapeutic technology, and expanding capacity to deal with public health emergencies. reform is also needed in international assistance to help less developed nations build the essential infrastructure to sustain public health in the struggle to combat aids, malaria, tuberculosis (tb), and the major causes of preventable infant, childhood, and motherhood-related deaths. the nearly universal recognition of the rights of people to have access to health care of acceptable quality by international standards is a challenge of political will and leadership backed up by adequate staffing with public health-trained staff and organizations. the challenges of the current global economic crisis are impacting social and health systems around the world. the interconnectedness of managing health systems is part of the new public health. setting the priorities and allocating resources to address these challenges requires public health training and orientation of the professionals and institutions participating in the policy, management, and economics of health systems. conversely, those who manage such institutions are recognizing the need for a wide background in public health training in order to fulfill their responsibilities effectively. concepts such as objectives, targets, priorities, cost-effectiveness, and evaluation have become part of the new public health agenda. an understanding of how these concepts evolved will help the future health provider or manager to cope with the complexities of mixing science, humanity, and effective management of resources to achieve higher standards of health, and to cope with new issues as they develop in the broad scope of the new public health for the twenty-first century, in what breslow called the "third public health era" of long and healthy quality of life (box . ). health can be defined from many perspectives, ranging from statistics on mortality, life expectancy, and morbidity rates to idealized versions of human and societal perfection, as in the world health organization's (who's) founding charter. the first public health era -the control of communicable diseases. second public health era -the rise and fall of chronic diseases. third public health era -the development of long and high-quality life. preamble to the constitution of the who, as adopted by the international health conference in new york in and signed by the representatives of states, entered into force on april , with the widely cited definition: "health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". this definition is still important conceptually as an ideal accepted as fundamental to public policy over the years. a more operational definition of health is a state of equilibrium of the person with the biological, physical, and social environment, with the object of maximum functional capability. health is thus seen as a state characterized by anatomical, physiological, and psychological integrity, and an optimal functional capability in the family, work, and societal roles (including coping with associated stresses), a feeling of well-being, and freedom from risk of disease and premature death. deviances in health are referred to as unhealthy and constitute a disease nomenclature. there are many interrelated factors in disease and in their management through what is now called risk reduction. in , claude bernard described the phenomenon of adaptation and adjustment of the internal milieu of the living organism to physiological processes. this concept is fundamental to medicine. it is also central to public health because understanding the spectrum of events and factors between health and disease is basic to the identification of contributory factors affecting the balance towards health, and to seeking the points of potential intervention to reverse the imbalance. as described in chapter , from the time of hippocrates and galen, diseases were thought to be due to humors and miasma or emanations from the environment. this was termed the miasma theory, and while without a direct scientific explanation, it was acted upon in the early to mid-nineteenth century and promoted by leading public health theorists including florence nightingale, with practical and successful measures to improve sanitation, housing, and social conditions, and having important results in improving health conditions. the competing germ theory developed by pioneering nineteenthcentury epidemiologists (panum, snow, and budd), scientists (pasteur, cohn, and koch), and practitioners (lister and semmelweiss) led to the science of bacteriology and a revolution in practical public health measures. the combined application of the germ (agent-host-environment) and miasma theories (social and sanitary environment) has been the basis of classic public health, with enormous benefits in the control of infectious and other diseases or harmful conditions. the revolutionary changes occurring since the s have brought about a decline in cardiovascular and cancer mortality, and conceptual changes such as health for all and health in all to bring health issues to all policies at both governmental and individual levels. the concepts of public health advanced with the marc lalonde health field concept (new perspectives on the health of canadians, ) , stating that health was the result of the physical and social environment, lifestyle and personal habits, genetics, as well as organization and provision of medical care. the lalonde report was a key concept leading to ideas advanced at the alma-ata conference on primary care held in and more explicitly in the development of the basis for health promotion as articulated in the ottawa charter of on health promotion. this marked the beginning of a whole new aspect of public health, which proved itself in addressing with considerable success the epidemic of hiv and cardiovascular diseases. in the usa, the surgeon general's reports of on smoking and health, and of defining health targets as national policy promoted the incorporation of "management by objectives" from the business world applied to the health sector (see chapter ). this led to healthy people usa and later versions, and the united nations (un) millennium development goals (mdgs), aimed primarily at the middle-and low-income countries (box . ). the identification of infectious causes of cancers of the liver and cervix established a new paradigm in epidemiology, and genetic epidemiology has important potential for public health and clinical medicine. in the basic host-agent-environment paradigm, a harmful agent comes through a sympathetic environment into contact with a susceptible host, causing a specific disease. this idea dominated public health thinking until the midtwentieth century. the host is the person who has or is at risk for a specific disease. the agent is the organism or direct cause of the disease. the environment includes the external factors which influence the host, his or her susceptibility to the agent, and the vector which transmits or carries the agent to the host from the environment. this explains the causation and transmission of many diseases. this paradigm (figure . ), in effect, joins together the contagion and miasma theories of disease causation. a specific agent, a method of transmission, and a susceptible host are involved in an interaction, which are central to the infectivity or severity of the disease. the environment can provide the carrier or vector of an infective (or toxic) agent, and it also contributes factors to host susceptibility; for example, unemployment, poverty, or low education level. the expanded host-agent-environment paradigm widens the definition of each of the three components ( figure . ), in relation to both acute infectious and chronic noninfectious disease epidemiology. in the latter half of the twentieth century, this expanded host-agent-environment paradigm took on added importance in dealing with the complex of factors related to chronic diseases, now the leading causes of disease and premature mortality in the developed world, and increasingly in developing countries. interventions to change host, environmental, or agent factors are the essence of public health. in infectious disease control, the biological agent may be removed by pasteurization of food products or filtration and disinfection (chlorination) of water supplies to prevent transmission of waterborne disease. the host may be altered by immunization to provide immunity to a specific infective organism. the environment may be changed to prevent transmission by destroying the vector or its reservoir of the disease. a combination of these interventions can be used against a specific risk factor, toxic or nutritional deficiency, infectious organism, or disease process. vaccine-preventable diseases may require both routine and special activities to boost herd immunity to protect the individual and the community. for other infectious diseases for which there is no vaccine (e.g., malaria), control involves a broad range of activities including case finding and treatment to improve the individual's health and to reduce the reservoir of the disease in the population, and other measures such as bed nets to reduce exposure of the host to vector mosquitoes, as well as vector control to reduce the mosquito population. tb control requires not only case finding and treatment, but understanding the contributory factors of social conditions, diseases with tb as a secondary condition (substance abuse and aids), agent resistance to treatment, and the inability of patients or carriers to complete treatment without supervision. sexually transmitted infections (stis) which are not controllable by vaccines require a combination of personal behavior change, health education, medical care, and skilled epidemiology. with non-infectious diseases, intervention is even more complex, involving human behavior factors and a wide range of legal, administrative, and educational issues. there may be multiple risk factors, which have a compounding effect in disease causation, and they may be harder to alter than infectious diseases factors. for example, smoking in and of itself is a risk factor for lung cancer, but exposure to asbestos fibers has a compounding effect. preventing exposure to the compounding variables may be easier than smoking cessation. reducing trauma morbidity and mortality is equally problematic. the identification of a single specific cause of a disease is of great scientific and practical value in modern public health, enabling such direct interventions as the use of vaccines or antibiotics to protect or treat individuals from infection by a causative organism, toxin, deficiency condition, or social factor. the cumulative effects of several contributing or risk factors in disease causation are also of great significance in many disease processes, in relation to infectious diseases such as nutritional status as for chronic diseases such as the cardiovascular group. the health of an individual is affected by risk factors intrinsic to that person as well as by external factors. intrinsic factors include the biological ones that the individual inherits and those life habits he or she acquires, such as smoking, overeating, or engaging in other high-risk behaviors. external factors affecting individual health include the environment, the socioeconomic and psychological state of the person, the family, and the society in which he or she lives. education, culture, and religion are also contributory factors to individual and community health. there are factors that relate to health of the individual in which the society or the community can play a direct role. one of these is provision of medical care. another is to ensure that the environment and community services include safety factors that reduce the chance of injury and disease, or include protective measures; for example, fluoridation of a community water supply to improve dental health, and seat-belt or helmet laws to reduce motor vehicle injury and death. these modifying factors may affect the response of the individual or the spread of an epidemic (see chapter ). an epidemic may also include chronic disease, because common risk factors may cause an excess of cases in a susceptible population group, in comparison to the situation before the risk factor appeared, or in comparison to a group not exposed to the risk factor. these include rapid changes or "epidemics" in such conditions as type diabetes, asthma, cardiovascular diseases, trauma, and other non-infectious disorders. disease is a dynamic process, not only of causation, but also of incubation or gradual development, severity, and the effects of interventions intended to modify outcome. knowledge of the natural history of disease is fundamental to understanding where and with what means intervention can have the greatest chance for successful interruption or change in the disease process for the patient, family, or community. the natural history of a disease is the course of that disease from beginning to end. this includes the factors that relate to its initiation; its clinical course leading up to resolution, cure, continuation, or long-term sequelae (further stages or complications of a disease); and environmental or intrinsic (genetic or lifestyle) factors and their effects at all stages of the disease. the effects of intervention at any stage of the disease are part of the disease process (figure . ). as discussed above, disease occurs in an individual when agent, host, and environment interact to create adverse conditions of health. the agent may be an infectious organism, a chemical exposure, a genetic defect, or a deficiency condition. a form of individual or social behavior, such as reckless driving or risky sexual behavior, may lead to injury or disease. the host may be immune or susceptible as a result of many contributing social and environmental factors. the environment includes the vector, which may be a malaria-bearing mosquito, a contaminated needle shared by drug users, lead-contaminated paint, or an abusive family situation. assuming a natural state of "wellness" -i.e., optimal health or a sense of well-being, function, and absence of disease -a disease process may begin with the onset of a disease, infectious or non-infectious, following a somewhat characteristic pattern of "incubation" described by clinicians and epidemiologists. preclinical or predisposing events may be detected by a clinical history, with determination of risk including possible exposure or presence of other risk factors. interventions, before and during the process, are intended to affect the later course of the disease. the clinical course of a disease, or its laboratory or radiological findings, may be altered by medical or public health intervention, leading to the resolution or continuation of the disease with fewer or less severe secondary sequelae. thus, the intervention becomes part of the natural history of the disease. the natural history of an infectious disease in a population will be affected by the extent of prior vaccination or previous exposure in the community. diseases particular to children are often so because the adult population is immune from previous exposure or vaccinations. measles and diphtheria, primarily childhood diseases, now affect adults to a large extent because they are less protected by naturally acquired immunity or are vulnerable when their immunity wanes naturally or as a result of inadequate vaccination in childhood. in chronic disease management, high costs to the patient and the health system accrue where preventive services or management are inadequate, not yet available, or inaccessible or where there is a failure to apply the necessary interventions. the progress of diabetes to severe complications such as cardiovascular, renal, and ocular disease is delayed or reduced by good management of the condition, with a combination of smoking cessation, diet, exercise, and medications with good medical supervision. the patient with advanced chronic obstructive pulmonary disease or congestive heart failure may be managed well and remain stable with smoking avoidance, careful management of medications, immunizations against influenza and pneumonia, and other prevention-oriented care needs. where these are not applied or if they fail, the patient may require long and expensive medical and hospital care. failure to provide adequate supportive care will show up in ways that are more costly to the health system and will prove more life-threatening to the patient. the goal is to avoid where possible the necessity for tertiary care, substituting tertiary prevention, i.e., supportive rehabilitation to maximum personal function and maintaining a stable functional status. as in an individual, the phenomenon of a disease in a population may follow a course in which many factors interplay, and where interventions affect the natural course of the disease. the epidemiological patterns of an infectious disease can be assessed in their occurrence in the population or their mortality rates, just as they can for individual cases. the classic mid-nineteenth-century description of measles in the faroe islands by panum showed the transmission and the epidemic nature of the disease as well as the protective effect of acquired immunity (see chapter ). similar, more recent breakthroughs in medical, epidemiological, biological, and social sciences have produced enormous benefit for humankind as discussed throughout this text, with some examples. these include the eradication of smallpox and in the coming years, poliomyelitis, measles, leprosy, and other dreaded diseases known for millennia; the near-elimination of rheumatic heart disease and peptic ulcers in the industrialized countries; vast reduction in mortality from stroke and coronary heart disease (chd); and vaccines (against hepatitis b and hpv) for the prevention of cancers. these and other great achievements of the twentieth and early part of the twenty-first centuries hold great promise for humankind in the coming decades, but great challenges lie ahead as well. the biggest challenge is to bring the benefits of known public health capacity to the poorest population of each country and the poorest populations globally. in developed countries a major challenge is to renew efforts of public health capacity to bear on prevention of chronic conditions such as diabetes and obesity, considered to be at pandemic proportions; and the individual and societal effects of mental diseases. in public health today, fears of a pandemic of avian influenza are based on transmission of avian or other animal-borne (zoonotic) prions or viruses to humans and then their adaptation permitting human-to-human spread. with large numbers of people living in close contact with many animals (wild and domestic fowl), such as in china and south-east asia, and rapid transportation around the world, the potential for global spread of disease is almost without historical precedent. indeed, many human infectious diseases are zoonotic in origin and transferred from natural wildlife reservoirs to humans either directly or via domestic or other wild animals, such as from birds to chickens to humans in avian influenza. monitoring or immunization of domestic animals requires a combination of multidisciplinary zoonotic disease management strategies, public education and awareness, and veterinary public health monitoring and control. rift valley fever, equine encephalitis, and more recently sars and avian influenza associated with bird-borne viral disease which can affect humans, each show the terrible dangers of pandemic diseases. ebola virus is probably sustained between outbreaks among fruit bats, or as recently suggested wild or domestic pigs, and may become a major threat to public health as human case fatality rates decline, meaning that patients and carriers, or genetic drift of the virus with possible airborne transmission, may spread this deadly disease more widely than in the past (see chapter ). the health of populations, like the health of individuals, depends on societal factors no less than on genetics, personal risk factors, and medical services. social inequalities in health have been understood and documented in public health over the centuries. the chadwick and shattuck reports of - documented the relationship of poverty and bad sanitation, housing, and working conditions with high mortality, and ushered in the idea of social epidemiology. political and social ideologies thought that the welfare state, including universal health care systems of one type or another, would eliminate social and geographic differences in health status and this is in large part true. from the introduction of compulsory health insurance in germany in the s to the failed attempt in the usa at national health insurance in (see chapters , and ) and the more recent achievements of us president obama in - , social reforms to deal with inequalities in health have focused on improving access to medical and hospital care. almost all industrialized countries have developed such systems, and the contribution of these programs to improve health status has been an important part of social progress, especially since world war ii. but even in societies with universal access to health care, people of lower socioeconomic status (ses) suffer higher rates of morbidity and mortality from a wide variety of diseases. the black report (douglas black) in the uk in the early s pointed out that the class v population (unskilled laborers) had twice the total and specific mortality rates of the class i population (professional and business) for virtually all disease categories, ranging from infant mortality to death from cancer. the report was shocking because all britons have had access to the comprehensive national health service (nhs) since its inception in , with access to a complete range of services at no cost at time of service, close relations to their general practitioners, and good access to specialty services. these findings initiated reappraisals of the social factors that had previously been regarded as the academic interests of medical sociologists and anthropologists and marginal to medical care. more recent studies and reviews of regional, ethnic, and socioeconomic differentials in patterns of health care access, morbidity, and mortality indicate that health inequities are present in all societies including the uk, the usa, and others, even with universal health insurance or services. the ottawa charter on health promotion in placed a new paradigm before the world health community that recognized social and political factors as no less important ion health that traditional medical and sanitary public health measures. these concepts helped the world health community to cope with new problems such as hiv/aidsfor which there was neither a medical cure nor a vaccine to prevent the disease. its control came to depend in the initial decades almost entirely on education and change in lifestyles, until the advent of the antiretroviral drugs in the s. there is still no viable vaccine. although the epidemiology of cardiovascular disease shows the direct relationship of the now classic risk factors of stress, smoking, poor diet, and physical inactivity, differences in mortality from cardiovascular disease between different classes among british civil servants are not entirely explainable by these factors. the differences are also affected by social and economic issues that may relate to the psychological needs of the individual, such as the degree of control people have over their own lives. blue-collar workers have less control over their lives, their working life in particular, than their white-collar counterparts, and have higher rates of chd mortality than higher social classes. other work shows the effects of migration, unemployment, drastic social and political change, and binge drinking, along with protective effects of healthy lifestyle, religiosity, and family support systems in cardiovascular diseases. social conditions affect disease distribution in all societies. in the usa and western europe, tb has re-emerged as a significant public health problem in urban areas partly because of high-risk population groups, owing to poverty and alienation from society, as in the cases of homelessness, drug abuse, and hiv infection. in countries of eastern europe and the former soviet union, the recent rise in tb incidence has resulted from various social and economic factors in the early s, including the large-scale release of prisoners. in both cases, diagnosis and prescription of medication are inadequate, and the community at large becomes at risk because of the development of antibioticresistant strains of tubercle bacillus readily spread by inadequately treated carriers, acting as human vectors. studies of ses and health are applicable and valuable in many settings. in alameda county, california, differences in mortality between black and white population groups in terms of survival from cancer became insignificant when controlled for social class. a -year follow-up study of the county population reported that low-income families in california are more likely than those on a higher income to have physical and mental problems that interfere with daily life, contributing to further impoverishment. studies of the association between indicators of ses and recent screening in the usa, australia, finland, and elsewhere showed that lower ses women use less preventive care such as papanicolaou (pap) smears for cervical cancer than women of higher ses, despite having greater risk for cervical cancer. many factors in ses inequalities are involved, including transportation and access to primary care, differences in health insurance coverage, educational levels, poverty, high-risk behaviors, social and emotional distress, feeling a lack of control over one's own life, employment, occupation, and inadequate family or community social support systems. many barriers exist owing to difficulties in access and the lack of availability of free or low-cost medical care, and the absence or limitations of health insurance is a further factor in the socioeconomic gradient. the recognition that health and disease are influenced by many factors, including social inequalities, plays a fundamental role in the new public health paradigm. health care systems need to take into account economic, social, physical, and psychological factors that otherwise will limit the effectiveness of even the best medical care. the health system includes access to competent and responsible primary care as well as by the wider health system, including health promotion, specific prevention and population-based health protection. the paradigm of the host-agent-environment triad (figures . and . ) is profoundly affected by the wider context. the sociopolitical environment and organized efforts at intervention affect the epidemiological and clinical course of disease of the individual. medical care is essential, as is public health, but the persistent health inequities seen in most regions and countries require societal attention. success or failure in improving the conditions of life for the poor, and other vulnerable "risk groups", affect national or regional health status and health system performance. the health system is meant to reduce the occurrence or bad outcome of disease, either directly by primary prevention or treatment as secondary prevention or by maximum rehabilitation as tertiary prevention, or equally important indirectly by reducing community or individual risk factors. the the effects of social conditions on health can be partly offset by interventions intended to promote healthful conditions; for example, improved sanitation, or through good-quality primary and secondary health services, used efficiently and effectively made available to all. the approaches to preventing disease or its complications may require physical changes in the environment, such as removal of the broad street pump handle to stop the cholera epidemic in london, or altering diets as in goldberger's work on pellagra. some of the great successes of public health have been and continue to be low technology. examples, among many others, include insecticide-impregnated bednets and other vector control measures, oral rehydration solutions, treatment and cure of peptic ulcers, exercise and diet to reduce obesity, hand washing in hospitals (and other health facilities), community health workers, and condoms and circumcision for the prevention of stis, including hiv and cancer of the cervix. the societal context in terms of employment, social security, female education, recreation, family income, cost of living, housing, and homelessness is relevant to the health status of a population. income distribution in a wealthy country may leave a wide gap between the upper and lower socioeconomic groups, which affects health status. the media have great power to sway public perception of health issues by choosing what to publish and the context in which to present information to society. modern media may influence an individual's tendency to overestimate the risk of some health issues while underestimating the risk of others, ultimately influencing health choices, such as occurred with public concern regarding false claims of an association between the measles-mumps-rubella (mmr) vaccine and autism in the uk (see the wakefield effect, chapter ). the new public health has an intrinsic responsibility for advocacy of improved societal conditions in its mission to promote optimal community health. an ultimate goal of public health is to improve health and to prevent widespread disease occurrence in the population and in an individual. the methods of achieving this are wide and varied. when an objective has been defined in "social justice is a matter of life and death. it affects the way people live, their consequent chance of illness, and their risk of premature death. we watch in wonder as life expectancy and good health continue to increase in parts of the world and in alarm as they fail to improve in others. a girl born today can expect to live for more than years if she is born in some countries -but less than years if she is born in others. within countries there are dramatic differences in health that are closely linked with degrees of social disadvantage. differences of this magnitude, within and between countries, simply should never happen. these inequities in health, avoidable health inequalities arise because of the circumstances in which people grow, live, work, and age, and the systems put in place to deal with illness. the conditions in which people live and die are, in turn, shaped by political, social, and economic forces. social and economic policies have a determining impact on whether a child can grow and develop to its full potential and live a flourishing life, or whether its life will be blighted. increasingly the nature of the health problems rich and poor countries have to solve are converging. the development of a society, rich or poor, can be judged by the quality of its population's health, how fairly health is distributed across the social spectrum, and the degree of protection provided from disadvantage as a result of ill-health." preventing disease, the next step is to identify suitable and feasible methods of achieving it, or a strategy with tactical objectives. this determines the method of operation, course of action, and resources needed to carry it out. the methods of public health are categorized as health promotion, and primary, secondary, and tertiary prevention (box . ). health promotion is the process of enabling people and communities to increase control over factors that influence their health, and thereby to improve their health (adapted from the ottawa charter of health promotion, ; box . ). health promotion is a guiding concept involving activities intended to enhance individual and community health and well-being (box . ). it seeks to increase involvement and control by the individual and the community in their own health. it acts to improve health and social welfare, and to reduce specific determinants of diseases and risk factors that adversely affect the health, well-being, and productive capacities of an individual or society, setting targets based on the size of the problem but also the feasibility of successful intervention, in a cost-effective way. this can be through direct contact with the patient or risk group, or act indirectly through changes in the environment, legislation, or public policy. control of aids relies on an array of interventions that promote change in sexual behavior and other contributory risks such as sharing of needles among drug users, screening of blood supply, safe hygienic practices in health care settings, and education of groups at risk such as teenagers, sex workers, migrant workers, and many others. control of aids is also a clinical problem in that patients need antiretroviral therapy (art), but this becomes a management and policy issue for making these drugs available and at an affordable price for the poor countries most affected. this is an example of the challenge and effectiveness of health promotion and the new public health. health promotion is a key element of the new public health and is applicable in the community, the clinic or hospital, and in all other service settings. some health promotion activities are government legislative and box . modes of prevention l health promotion -fostering national, community, and individual knowledge, attitudes, practices, policies, and standards conducive to good health; promoting legislative, social, or environmental conditions; promoting knowledge and practices for self-care that reduce individual and community risk; and creating a healthful environment. it is directed toward action on the determinants of health. l health protection -activities of official health departments or other agencies empowered to supervise and regulate food hygiene, community and recreational water safety, environmental sanitation, occupational health, drug safety, road safety, emergency preparedness, and many other activities to eliminate or reduce as much as possible risks of adverse consequences to health. l primary prevention -preventing a disease from occurring, e.g., vaccination to prevent infectious diseases, advice to stop smoking to prevent lung cancer. l secondary prevention -making an early diagnosis and giving prompt and effective treatment to stop progress or shorten the duration and prevent complications from an already existing disease process, e.g., screening for hypertension or cancer of cervix and colorectal cancer for early case finding, early care and better outcomes. l tertiary prevention -stopping progress of an already occurring disease, and preventing complications, e.g., in managing diabetes and hypertension to prevent complications; restoring and maintaining optimal function once the disease process has stabilized, e.g., promoting functional rehabilitation after stroke and myocardial infarction with long-term follow-up care. health promotion (hp) is the process of enabling people to increase control over, and to improve their health. hp represents a comprehensive social and political process, and not only embraces actions directed at strengthening the skills and capabilities of individuals. hp also undertakes action directed towards changing social, environmental, and economic conditions so as to alleviate their impact on public and individual health. health promotion is the process of enabling people to increase control over the determinants of health and thereby improve their health. participation is essential to sustain health promotion action. the ottawa charter identifies three basic strategies for health promotion. these are advocacy for health to create the essential conditions for health indicated above; enabling all people to achieve their full health potential; and mediating between the different interests in society in the pursuit of health. these strategies are supported by five priority action areas as outlined in the ottawa charter for health promotion: regulatory interventions such as mandating the use of seat belts in cars, requiring that children be immunized to attend school, declaring that certain basic foods must have essential minerals and vitamins added to prevent nutritional deficiency disorders in vulnerable population groups, and mandating that all newborns should be given prophylactic vitamin k to prevent hemorrhagic disease of the newborn. setting food and drug standards and raising taxes on cigarettes and alcohol to reduce their consumption are also part of health promotion. promoting a healthy lifestyle is a major known obesity-preventive activity. health promotion is provided by organizations and people with varied professional backgrounds working towards common goals of improvement in the health and quality of individual and community life. initiatives may come from government with dedicated allocation of funds to address specific health issues, from donors, or from advocacy or community groups or individuals to promote a specific or general cause in health. raising awareness to inform and motivate people about their own health and lifestyle factors that might put them at risk requires teaching young people about the dangers of sexually transmitted diseases, smoking, and alcohol abuse to reduce risks associated with their social behavior. it might include disseminating information on healthy nutrition; for example, the need for folic acid supplements for women of childbearing age and multiple vitamins for elderly, as well as the elements of a healthy diet, compliance with immunization recommendations, compliance with screening programs, and many others. community and peer group attitudes and standards affect individual behavior. health promotion endeavors to create a climate of knowledge, attitudes, beliefs, and practices that are associated with better health outcomes. international conferences following on from the ottawa charter were held in adelaide in , sundsvall in , jakarta in , mexico in , bangkok in , and nairobi in . the principles of health promotion have been reiterated and have influenced public policy regarding public health as well as the private sector. health promotion has a track record of proven success in numerous public health issues where a biomedical solution was not available. the hiv/aids pandemic from the s until the late s had no medical treatment and control measures relied on screening, education, lifestyle changes, and supportive care. health promotion brought forward multiple interventions, from condom use and distribution, to needle exchanges for intravenous drug users, to male circumcision in high-prevalence african countries. medical treatment was severely limited until art was developed. the success of art also depends on a strong element of health promotion in widening the access to treatment and the success of medications to reduce transmission, most remarkably in reducing maternal-fetal transmission (see chapter ). similarly, in the battle against cardiovascular diseases, health promotion was an instrumental factor in raising public awareness of the importance of management of hypertension and smoking reduction, dietary restraint, and physical exercise. the success of massive reductions in stroke and chd mortality is as much the result of health promotion as of improved medical care (see chapter ). the character of public health carries with it a "good cop, bad cop" dichotomy. the "good cop" is persuasive and educational trying to convince people to do the right thing in looking after their own health: diet, exercise, smoking cessation, and others. on the other side, the "bad cop" role is regulatory and punitive. public health has a serious responsibility and role in the enforcement of laws and regulation to protect the public health. some of these are restrictive box . elements of health promotion . address the population as a whole in health-related issues, in everyday life as well as people at risk for specific diseases. . direct action to risk factors or causes of illness or death. . undertake activist approach to seek out and remedy risk factors in the community that adversely affect health. . promote factors that contribute to a better condition of health of the population. . initiate actions against health hazards, including communication, education, legislation, fiscal measures, organizational change, community development, and spontaneous local activities. . involve public participation in defining problems and deciding on action. . advocate relevant environmental, health, and social policy. . encourage health professional participation in health education and health advocacy. . advocate for health based on human rights and solidarity. . invest in sustainable policies, actions, and infrastructure to address the determinants of health. . build capacity for policy development, leadership, health promotion practice, knowledge transfer and research, and health literacy. . regulate and legislate to ensure a high level of protection from harm and enable equal opportunity for health and well-being for all people. . partner and build alliances with public, private, nongovernmental, and international organizations and civil society to create sustainable actions. . make the promotion of health central to the global development agenda. of individual rights that may damage other people or are requirements based on strong evidence of benefits to population health. readily accepted are food and drug standards, such as pasteurization of milk, and iodization of salt; requirements to drive on the right-hand side of the road (except in some countries such as the uk), to wear seat belts and for motorcyclists to wear safety helmets; and not smoking in public places. enforcement of these and similar statutory or regulatory requirements is vital in a civil society to protect the public from health hazards and to protect people from harm and exploitation by unscrupulous manufacturers and marketing. cigarette advertising and sponsorship of sports events by tobacco companies are banned in most upper income countries. the use of transfats in food manufacturing and baking is now banned and salt reduction is being promoted and even mandated in many us local authorities to reduce cardiovascular disease. advertising of unhealthy snack foods on children's television programs and during child-watching hours is commonly restricted. banning high-sugar soda drink distribution in schools is a successful intervention to reduce the current child obesity epidemic. melamine use in milk powders and baby formulas, which caused widespread illness and death of infants in china, is now banned and a punishable offence for manufacture or distribution in china and worldwide. examples of this aspect of public health are mentioned throughout this text, especially in chapters and on nutrition, and environmental and occupational health, respectively. the regulatory enforcement function of public health is sometimes controversial and portrayed as interference with individual liberty. fluoridation of community water supplies is an example where aggressive lobby groups opposing this safe and effective public health measure are still common. this is discussed in chapter . equally important is the public health policy issue of resource allocation and taxation for health purposes. taxation is an unpopular measure that governments must employ and enforce in order to do the public's business. the debate over the patient protection and affordable care act (ppaca or "obamacare"), discussed elsewhere in this and other chapters, shows how bitter the arguments can become, yet the goal of equality of access to health care cannot be denied as a public good, demonstrably contributing to the health of the nation. primary prevention refers to those activities that are undertaken to prevent disease or injury from occurring at all. primary prevention works with both the individual and the community. it may be directed at the host to increase resistance to the agent (such as in immunization or cessation of smoking), or at environmental activities to reduce conditions favorable to the vector for a biological agent, such as mosquito vectors of malaria or dengue fever. landmark examples include the treatment and prevention of scurvy among sailors based on james lind's findings in a classic clinical epidemiological study in , and john snow's removal of the handle from the broad street pump to stop a cholera epidemic in london in (see chapter ). primary prevention includes elements of health protection such as ensuring water, food and drug, and workplace safety; chlorination of drinking water to prevent transmission of waterborne enteric diseases; pasteurization of milk to prevent gastrointestinal diseases; mandating wearing seat belts in motor vehicles to prevent serious injury and death in road crashes; and reducing the availability of firearms to reduce injury and death from intentional, accidental, or random violence. it also includes direct measures to prevent diseases, such as immunization to prevent polio, tetanus, pertussis, and diphtheria. health promotion and health protection blend together as a group of activities that reduce risk factors and diseases through many forms of intervention such as changing smoking legislation or preventing birth defects by fortification of flour with folic acid. prevention of hiv transmission by needle exchange for intravenous drug users, promoting condom usage, and promoting male circumcision in africa, and the distribution of condoms and clean needles for hivpositive drug users are recent examples of primary prevention associated with health promotion programs. primary prevention also includes activities within the health system that can lead to better health. this may mean, for example, setting standards and to reduce hospital infections, and ensuring that doctors not only are informed of appropriate immunization practices and modern prenatal care or screening programs for cancer of the cervix, colon, and breast, but also are aware of their vital role in preventing cardiovascular and other non-communicable diseases. in this role, the health care provider serves as a teacher and guide, as well as a diagnostician and therapist. like health promotion, primary prevention does not depend on health care providers alone; health promotion works to increase individual and community consciousness of self-care, mainly by raising awareness and information levels and empowering the individual and the community to improve self-care, to reduce risk factors, and to live healthier lifestyles. secondary prevention is early diagnosis and management to prevent complications from a disease. public health interventions to prevent the spread of disease include the identification of sources of the disease and the implementation of steps to stop it, as shown in snow's closure of the broad street pump. secondary prevention includes steps to isolate cases and treat or immunize contacts so as to prevent further cases of meningitis or measles, for example, in outbreaks. for current epidemics such as hiv/aids, primary prevention is largely based on education, abstinence from any and certainly risky sexual behavior, circumcision, and treatment of patients in order to improve their health and to reduce the risk of spread of hiv. for high-risk groups such as intravenous drug users, needleexchange programs reduce the risk of spread of hiv, and hepatitis b and c. distribution of condoms to teenagers, military personnel, truck drivers, and commercial sex workers helps to prevent the spread of stis and aids in schools and colleges, as well as among the military. the promotion of circumcision is shown to be effective in reducing the transmission of hiv and of hpv (the causative organism for cancer of the cervix). all health care providers have a role in secondary prevention; for example, in preventing strokes by early identification and adequate care of hypertension. the child who has an untreated streptococcal infection of the throat may develop complications which are serious and potentially life-threatening, including rheumatic fever, rheumatic valvular heart disease, and glomerulonephritis. a patient found to have elevated blood pressure should be advised about continuing management by appropriate diet and weight loss if obese, regular physical exercise, and long-term medication with regular follow-up by a health provider in order to reduce the risk of stroke and other complications. in the case of injury, competent emergency care, safe transportation, and good trauma care may reduce the chance of death and/or permanent handicap. screening and high-quality care in the community prevent complications of diabetes, including heart, kidney, eye, and peripheral vascular disease. they can also prevent hospitalizations, amputations, and strokes, thus lengthening and improving the quality of life. health care systems need to be actively engaged in secondary prevention, not only as individual doctors' services, but also as organized systems of care. public health also has a strong interest in promoting highquality care in secondary and tertiary care hospital centers in such areas of treatment as acute myocardial infarction, stroke, and injury in order to prevent irreversible damage. measures include quality of care reviews to promote adequate longterm postmyocardial infarction care with aspirin and betablockers or other medication to prevent or delay recurrence and second or third myocardial infarctions. the role of highquality transportation and care in emergency facilities of hospitals in public health is vital to prevent long-term damage and disability; thus, cardiac care systems including publicly available defibrillators, catheterization, the use of stents, and bypass procedures are important elements of health care policy and resource allocation, which should be accessible not only in capital cities but also to regional populations. tertiary prevention involves activities directed at the host or patient, but also at the social and physical environment in order to promote rehabilitation, restoration, and maintenance of maximum function after the disease and its complications have stabilized. the person who has undergone a cerebrovascular accident or trauma will reach a stage where active rehabilitation can help to restore lost functions and prevent recurrence or further complications. the public health system has a direct role in the promotion of disability-friendly legislation and standards of building, housing, and support services for chronically ill, handicapped, and elderly people. this role also involves working with many governmental social and educational departments, but also with advocacy groups, ngos, and families. it may also include the promotion of disability-friendly workplaces and social service centers. treatment for conditions such as myocardial infarction or a fractured hip now includes early rehabilitation in order to promote early and maximum recovery with restoration to optimal function. the provision of a wheelchair, walkers, modifications to the home such as special toilet facilities, doors, and ramps, along with transportation services for paraplegics are often the most vital factors in rehabilitation. public health agencies work with groups in the community concerned with promoting help for specific categories of risk group, disease, or disability to reduce discrimination. community action is often needed to eliminate financial, physical, or social barriers, promote community awareness, and finance special equipment or other needs of these groups. close follow-up and management of chronic disease, physical and mental, require home care and ensuring an appropriate medical regimen including drugs, diet, exercise, and support services. the follow-up of chronically ill people to supervise the taking of medications, monitor changes, and support them in maximizing their independent capacity in activities of daily living is an essential element of the new public health. public health uses a population approach to achieve many of its objectives. this requires defining the population, including trends of change in the age and gender distribution of the population, fertility and birth rates, spread of disease and disability, mortality, marriage and migration, and socioeconomic factors. the reduction of infectious disease as the major cause of mortality, increased longevity coupled with declining fertility rates, resulted in changes in the age composition, or a demographic transition. demographic changes, such as fertility and mortality patterns, are important factors in changing the age distribution of the population, resulting in a greater proportion of people surviving to older ages. declining infant mortality, increasing educational levels of women, the availability of birth control, and other social and economic factors lead to changes in fertility patterns and the demographic transition -an aging of the population -with important effects on health service needs. the age and gender distribution of a population affects and is affected by patterns of disease. change in epidemiological patterns, or an epidemiological shift, is a change in predominant patterns of morbidity and mortality. the transition of infectious diseases becoming less prominent as causes of morbidity and mortality and being replaced by chronic and non-infectious diseases has occurred in both developed and developing countries. the decline in mortality from chronic diseases, such as cardiovascular disease, represents a new stage of epidemiological transition, creating an aging population with higher standards of health but also long-term community support and care needs. monitoring and responding to these changes are fundamental responsibilities of public health, and a readiness to react to new, local, or generalized changes in epidemiological patterns is vital to the new public health. societies are not totally homogeneous in ethnic composition, levels of affluence, or other social markers. on one hand, a society classified as developing may have substantial numbers of people with incomes that promote overnutrition and obesity, so that disease patterns may include increasing prevalence of diseases of excesses, such as diabetes. on the other hand, affluent societies include population groups with disease patterns of poverty, including poor nutrition and low birth-weight babies. a further stage of epidemiological transition has been occurring in the industrialized countries since the s, with dramatic reductions in mortality from chd, stroke and, to a lesser extent, trauma. the interpretation of this epidemiological transition is still not perfectly clear. how it occurred in the industrialized western countries but not in those of the former soviet union is a question whose answer is vital to the future of health in russia and some countries of eastern europe. developing countries must also prepare to cope with increasing epidemics of non-infectious diseases, and all countries face renewed challenges from infectious diseases with antibiotic resistance or newly appearing infectious agents posing major public health threats. demographic change in a country may reflect social and political decisions and health system priorities from decades before. russia's rapid population decline since the s, china's gender imbalance with a shortage of millions of young women, egypt's rapid population growth outstripping economic capacity, and many other examples indicate the severity and societal importance of capacity to analyze and formulate public health and social policies to address such fundamental sociopolitical issues. aging of the population is now the norm in most developed countries as a result of low birth and declining mortality rates. this change in the age distribution of a population has many associated social and economic issues as to the future of social welfare with a declining age cohort to provide the workforce. the aging population requires pension and health care support which make demands of social security systems that will depend on economic growth with a declining workforce. in times of economic stress, as in europe, this situation is made more difficult by longstanding short working weeks, early pension ages, and high social benefits. however, this results in unemployment among young people in particular and social conflict. the interaction of increasing life expectancy and a declining workforce is a fundamental problem in the high-income countries. this imbalance may be resolved in part through productivity gains and switching of primary production to countries with large still underutilized workforces, while employment in the developed countries will depend on service industries including health and the economic growth generated by higher technology and intellectual property and service industries. the challenge of keeping populations and individuals healthy is reflected in modern health services. each component of a health service may have developed with different historical emphases, operating independently as a separate service under different administrative auspices and funding systems, competing for limited health care resources. in this situation, preventive community care receives less attention and resources than more costly treatment services. figure . suggests a set of health services in an interactive relationship to serve a community or defined population, but the emphasis should be on the interdependence of these services with one other and with the comprehensive network in order to achieve effective use of resources and a balanced set of services for the patient, the client or patient population, and the community. clinical medicine and public health each play major roles in primary, secondary, and tertiary prevention. each may function separately in their roles in the community, but optimal success lies in their integrated efforts. allocation of resources should promote management and planning practices to assist this integration. there is a functional interdependence of all elements of health care serving a definable population. the patient should be the central figure in the continuum or complex of services available. effectiveness in use of resources means that providing the service most appropriate for meeting the individual's or group's needs at a point in time are those that should be applied. this is the central concept in currently developing innovations in health care delivery in the usa with organizations using terms such as patient centered medical home, accountable care organizations (acos), and population health management systems, which are being promoted in the obamacare health reforms now in process (see chapter ) (shortell et al., ) . separate organization and financing of services place barriers to appropriate provision of services for both the community and the individual patient. the interdependence of services is a challenge in health care organizations for the future. where there is competition for limited resources, pressures for tertiary services often receive priority over programs to prevent children from dying of preventable diseases. public health must be seen in the context of all health care and must play an influential role in promoting prevention at all levels. clinical services need public health in order to provide prevention and community health services that reduce the burden of disease, disability, and dependence on the institutional setting. health was traditionally thought of as a state of absence of disease, pain, or disability, but has gradually been expanded to include physical, mental, and societal well-being. in , c. e. a. winslow, professor of public health at yale university, defined public health as follows: "public health is the science and art of ( ) preventing disease, ( ) prolonging life, and ( ) winslow's far-reaching definition remains a valid framework but is unfulfilled when clinical medicine and public health have financing and management barriers between them. in many countries, isolation from the financing and provision of medical and nursing care services left public health with the task of meeting the health needs of the indigent and underserved population groups with inadequate resources and recognition. health insurance organizations for medical and hospital care have in recent years been more open to incorporating evidence-based preventive care, but the organization of public health has lacked the same level of attention. in some countries, the limitations have been conceptual in that public health was defined primarily in terms of control of infectious, environmental, and occupational diseases. a more recent and widely used definition is: "public health is the science and art of preventing disease, prolonging life, and promoting health through the organized efforts of society." this definition, coined in in the public health in england report by sir donald acheson, reflects the broad focus of modern public health. terms such as social hygiene, preventive medicine, community medicine, and social medicine have been used to denote public health practice over the past century. preventive medicine is the application of preventive measures by clinical practitioners combining some elements of public health with clinical practice relating to individual patients. preventive medicine defines medical or clinical personal preventive care, with stress on risk groups in the community and national efforts for health promotion. the focus is on the health of defined populations to promote health and well-being using evidence-based guidelines for cost-effective preventive measures. measures emphasized include screening and follow-up of chronic illnesses, and immunization programs; for example, influenza and pneumococcal pneumonia vaccines are used by people who are vulnerable because of their age, chronic diseases, or risk of exposure, such as medical and nursing personnel and those providing other personal clinical services. clinical medicine also deals in the area of prevention in the management of patients with hypertension or diabetes, and in doing so prevents the serious complications of these diseases. social medicine is also primarily a medical specialty which looks at illness in an individual in the family and social context, but lacks the environmental and regulatory and organized health promotion functions of public health. community health implies a local form of health intervention, whereas public health more clearly implies a global approach, which includes action at the international, national, state, and local levels. some issues in health can be dealt with at the individual, family, or community level; others require global strategies and intervention programs with regional, national, or international collaboration and leadership. the social medicine movement originated to address the harsh conditions of the working population during the industrial revolution in mid-nineteenth-century europe. an eminent pioneer in cellular pathology, rudolph virchow provided leadership in social medicine powered by the revolutionary movements of , and subsequent social democrat political movements. their concern focused on harsh living and health conditions among the urban poor working class and neglectful political norms of the time. social medicine also developed as an academic discipline and advocacy orientation by providing statistical evidence showing, as in various governmental reports in the mid-nineteenth century, that poverty among the working class was associated with short life expectancy and that social conditions were key factors in the health of populations and individuals. this movement provided the basis for departments in medical faculties and public health education throughout the world stressing the close relationship between political priorities and health status. this continued in the twentieth century and in the usa found expression in pioneering work since the s at montefiore hospital in new york and with victor sidel, founding leader of the community health center movement the usa from the s. in the twenty-first century this movement continues to emphasize relationships between politics, society, disease, and medicine, and forms of medical practice derived from it, as enunciated by prominent advocates such as harvardbased paul farmer in haiti, russia and rwanda, and in the uk by martin mckee and others (nolte and mckee, ) . similar concepts are current in the usa under headings such as family medicine, preventive medicine, and social medicine. this movement has also influenced sir michael marmot and others in the world health commission of health inequalities of , with a strong influence on the un initiative to promote mdgs, whose first objective is poverty reduction (commission on inequalities report ). application of the idea of poverty reduction as a method of reducing health inequalities has been successful recently in a large field trial in brazil showing greater reduction in child mortality where cash bonuses were awarded by municipalities for the poor families than that observed in other similar communities (rasella, ). in the usa, this movement is supported by increased health insurance coverage for the working poor, with funding for preventive care and incentives for community health centers in the obamacare plan of for implementation in the coming years to provide care for uninsured and underserved populations, particularly in urban and rural poverty areas. the political aspect of social medicine is the formulation of and support for national initiatives to widen health care coverage to the percent of the us population who are still uninsured, and to protect those who are arbitrarily excluded owing to previous illnesses, caps on coverage allowed, and other exploitative measures taken by private insurance that frequently deny americans access to the high levels of health care available in the country. the ethical base of public health in europe evolved in the context of its successes in the nineteenth and early twentieth centuries along with ideas of social progress. but the twentieth century was also replete with extremism and wide-scale abuse of human rights, with mass executions, deportations, and starvation as official policy in fascist and stalinist regimes. eugenics, a pseudoscience popularized in the early decades of the twentieth century, promoted social policies meant to improve the hereditary qualities of a race by methods such as sterilization of mentally handicapped people. the "social and racial hygiene" of the eugenics movements led to the medicalization of sterilization in the usa and other countries. this was adopted and extended in nazi germany to a policy of murder, first of the mentally and physically handicapped and then of "racial inferiors". these eugenics theories were widely accepted in the medical community in germany, then used by the nazi regime to justify medically supervised killing of hundreds of thousands of helpless, incapacitated individuals. this practice was linked to wider genocide and the holocaust, with the brutalization and industrialized murder of over million jews and million other people, and corrupt medical experimentation on prisoners. following world war ii, the ethics of medical experimentation (and public health) were codified in the nuremberg code and universal declaration of human rights based on lessons learned from these and other atrocities inflicted on civilian populations (see chapter ). threats of genocide, ethnic cleansing, and terrorism are still present on the world stage, often justified by current warped versions of racial hygienic theories. genocidal incitement and actual genocide and terrorism have recurred in the last decades of the twentieth century and into the twenty-first century in the former yugoslav republics, africa (rwanda and darfur), south asia, and elsewhere. terrorism against civilians has become a worldwide phenomenon with threats of biological and chemical agents, and potentially with nuclear capacity. asymmetrical warfare of insurgencies which use innocent civilians for cover, as with other forms of warfare, carries with it grave dangers to public health, human rights, and international stability, as seen in the twenty-first century in south sudan, darfur, dr congo, chechnya, iraq, afghanistan, and pakistan. in , kerr white and colleagues defined medical ecology as population-based research providing the foundation for management of health care quality. this concept stresses a population approach, including those not attending and those using health services. this concept was based on previous work on quality of care, randomized clinical trials, medical audit, and structure-process-outcome research. it also addressed health care quality and management. these themes influenced medical research by stressing the population from which clinical cases emerge as well as public health research with clinical outcome measures, themes that recur in the development of health services research and, later, evidence-based medicine. this led to the development of the agency for health care policy and research and development in the us department of health and human services and evidence-based practice centers to synthesize fundamental knowledge for the development of information for decision-making tools such as clinical guidelines, algorithms, or pathways. clinical guidelines and recommended best practices have become part of the new public health to promote quality of patient care and public health programming. these can include recommended standards; for example, follow-up care of the postmyocardial infarction patient, an internationally recommended immunization schedule, recommended dietary intake or food fortification standards, and mandatory vitamin k and eye care for all newborns and many others (see chapter ). community-oriented primary care (copc) is an approach to primary health care that links community epidemiology and appropriate primary care, using proactive responses to the priority needs identified. copc, originally pioneered in south africa and israel by sidney and emily kark and colleagues in the s and s, stresses medical services in the community which need to be adapted to the needs of the population as defined by epidemiological analysis. copc involves community outreach and education, as well as clinical preventive and treatment services. copc focuses on community epidemiology and an active problem-solving approach. this differs from national or larger scale planning that sometimes loses sight of the local nature of health problems or risk factors. copc combines clinical and epidemiological skills, defines needed interventions, and promotes community involvement and access to health care. it is based on linkages between the different elements of a comprehensive basket of services along with attention to the social and physical environment. a multidisciplinary team and outreach services are important for the program, and community development is part of the process. in the usa, the copc concept has influenced health care planning for poor areas, especially provision of federally funded community health centers in attempts to provide health care for the underserved since the s. in more recent years, copc has gained wider acceptance in the usa, where it is associated with family physician training and community health planning based on the risk approach and "managed care" systems. indeed, the three approaches are mutually complementary (box . ). as the emphasis on health care reform in the late s moved towards managed care, the principles of copc were and will continue to be important in promoting health and primary prevention in all its modalities, as well as tertiary prevention with followup and maintenance of the health of the chronically ill. copc stresses that all aspects of health care have moved towards prevention based on measurable health issues in the community. through either formal or informal linkages between health services, the elements of copc are part of the daily work of health care providers and community services systems. the us institute of medicine issued the report on primary care in , defining primary care as "the provision of integrated, accessible health care services by clinicians who are accountable for addressing the majority of personal health care needs, developing a sustained partnership with patients and practicing in the context of the family and the community". this formulation was criticized by the american public health association (apha) as lacking a public health perspective and failing to take into account both the individual and the community health approaches. copc tries to bridge this gap between the perspectives of primary care and public health. the community, whether local, regional, or national, is the site of action for many public health interventions. moreover, understanding the characteristics of the community is vital to a successful community-oriented approach. by the s, new patterns of public health began to emerge, including all measures used to improve the health of the community, and at the same time working to protect and promote the health of the individual. the range of activities to achieve these general goals is very wide, including individual patient care systems and the community-wide activities that affect the health and well-being of the individual. these include the financing and management of health systems, evaluation of the health status of the population, and measures to improve the quality of health care. they place reliance on health promotion activities to change environmental risk factors for disease and death. they promote integrative and multisectoral approaches and the international health teamwork required for global progress in health. the definition of health in the charter of the who as a complete state of physical, mental, and social well-being had a ring of utopianism and irrelevance to states struggling to provide even minimal care in severely adverse political, economic, social, and environmental conditions (box . ). in , a more modest goal was set for attainment of a level of health compatible with maximum feasible social and economic productivity. one needs to recognize that health and disease are on a dynamic continuum that affects everyone. the mission for public health is to use a wide range of methods to prevent disease and premature death, and improve quality of life for the benefit of individuals and the community. the world health organization defines health as "a state of complete physical, mental and social well-being, not merely the absence of disease or infirmity" (who constitution, ) . in at the alma-ata conference on primary health care, the who related health to "social and economic productivity in setting as a target the attainment by all the people of the world of a level of health that will permit them to lead a socially and economically productive life". three general programs of work for the periods - , - , and - were formulated as the basis of national and international activity to promote health. in , the who, recognizing changing world conditions of demography, epidemiology, environment, and political and economic status, addressed the unmet needs of developing countries and health management needs in the industrialized countries, calling for international commitment to "attain targets that will make significant progress towards improving equity and ensuring sustainable health development". the object of the who is restated as "the attainment by all peoples of the highest possible level of health" as defined in the who constitution, by a wide range of functions in promoting technical cooperation, assisting governments, and providing technical assistance, international cooperation, and standards. in the s, most industrialized countries were concentrating energies and financing in health care on providing access to medical and hospital services through national insurance schemes. developing countries were often spending scarce resources trying to emulate this trend. the who was concentrating on categorical programs, such as eradication of smallpox and malaria, as well as the expanded program of immunization and similar specific efforts. at the same time, there was a growing concern that developing countries were placing too much emphasis and expenditure on curative services and not enough on prevention and primary care. the world health assembly (wha) in endorsed the primary care approach under the banner of "health for all by the year " (hfa ) . this was a landmark decision and has had important practical results. the who and the united nations children's fund (unicef) sponsored a seminal conference held in alma-ata, in the ussr ( kazakhstan), in , which was convened to refocus health policy on primary care. the alma-ata declaration stated that health is a basic human right, and that governments are responsible to assure that right for their citizens and to develop appropriate strategies to fulfill this promise. this proposition has come to be increasingly accepted in the international community. the conference stressed the right and duty of people to participate in the planning and implementation of their health care. it advocated the use of scientifically, socially, and economically sound technology. joint action through intersectoral cooperation was also emphasized. the alma-ata declaration focused on primary health care as the appropriate method of assuming adequate access to health care for all (box . ). many countries have gradually come to accept the notion of placing priority on primary care, resisting the temptation to spend high percentages of health care resources on high-tech and costly medicine. spreading these same resources into highly costeffective primary care, such as immunization and nutrition programs, provides greater benefit to individuals and to society as a whole. alma-ata provided a new sense of direction for health policy, applicable to developing countries and in a different way than the approaches of the developed countries. during the s, the health for all concept influenced national health policies in the developing countries with signs of progress in immunization coverage, for example, but the initiative was diluted as an unintended consequence by more categorical programs such as eradication of poliomyelitis. for example, developing countries have accepted immunization and diarrheal disease control as high-priority issues and achieved remarkable success in raising immunization coverage from some percent to over percent in just a decade. developed countries addressed these principles in different ways. in these countries, the concept of primary health care led directly to important conceptual developments in health. national health targets and guidelines are now common in many countries and are integral parts of box . declaration of alma-ata, : a summary of primary health care (phc) . reaffirms that health is a state of complete physical, mental, and social well-being, and not merely the absence of disease or infirmity, and is a fundamental human right. existing gross inequalities in the health status of the people, particularly between developed and developing countries as well as within countries, are of common concern to all countries. . governments have a responsibility for the health of their people. the people have the right and duty to participate in planning and implementation of their health care. . a main social target is the attainment, by all peoples of the world by the year , of a level of health that will permit them to lead a socially and economically productive life. . phc is essential health care based on practical, scientifically sound, and socially acceptable methods and technology. . it is the first level of contact of individuals, the family, and the national health system bringing health care as close as possible to where people live and work, as the first element of a continuing health care process. . phc evolves from the conditions and characteristics of the country and its communities, based on the application of social, biomedical, and health services research and public health experience. . phc addresses the main health problems in the community, providing promotive, preventive, curative, and rehabilitative services accordingly. . phc includes the following: (a) education concerning prevailing health problems and methods of preventing and controlling them (b) promotion of food supply and proper nutrition (c) adequate supply of safe water and basic sanitation (d) maternal and child health care, including family planning (e) immunization against the major infectious diseases (f) prevention of locally endemic diseases (g) appropriate treatment of common diseases and injuries (h) the provision of essential drugs (i) relies on all health workers … to work as a health team. . all governments should formulate national health policies, strategies and plans, mobilize political will and resources, used rationally, to ensure phc for all people. national health planning. reforms of the nhs -for example, as discussed in chapter , remuneration increases for family physicians and encouraging group practice with public health nursing support -have become widespread in the uk. leading health maintenance organizations, such as kaiser permanente in the usa and district health systems in canada, have emphasized integrated approaches to health care for registered or geographically defined populations (see chapters - ). this approach is becoming common in the usa in acos, which will be fostered by the obamacare legislation (ppaca). this systematic approach to individual and community health is an integral part of the new public health. the interactions among community public health, personal health services, and health-related behavior, including their management, are the essence of the new public health. how the health system is organized and managed affects the health of the individual and the population, as does the quality of providers. health information systems with epidemiological, economic, and sociodemographic analysis are vital to monitor health status and allow for changing priorities and management. well-qualified personnel are essential to provide services, manage the system, and carry out relevant research and health policy analysis. diffusion of data, health information, and responsibility helps to provide a responsive and comprehensive approach to meet the health needs of the individual and community. the physical, social, economic, and political environments are all important determinants of the health status of the population and the individual. joint action (intersectoral cooperation) between public and non-governmental or community-based organizations is needed to achieve the well-being of the individual in a healthy society. in the s and s, these ideas contributed to an evolving new public health, spurred on by epidemiological changes, health economics, the development of managed care linking health systems, and prepayment. knowledge and self-care skills, as well as community action to reduce health risks, are no less important in this than the roles of medical practitioners and institutional care. all are parts of a coherent holistic approach to health. the concept of selective primary care, articulated in by walsh and warren, addresses the needs of developing countries to select those interventions on a broad scale that would have the greatest positive impact on health, taking into account limited resources such as money, facilities, and human resources. the term selective primary care is meant to define national priorities that are based not on the greatest causes of morbidity or mortality, but on common conditions of epidemiological importance for which there are effective and simple preventive measures. throughout health planning, there is an implicit or explicit selection of priorities for allocation of resources. even in primary care, selection of targets is a part of the process of resource allocation. in modern public health, this process is more explicit. a country with limited resources and a high birth rate will emphasize maternal and child health before investing in geriatric care. this concept has become part of the microeconomics of health care and technology assessment, discussed in chapters and , respectively, and is used widely in setting priorities and resource allocation. in developing countries, cost-effective primary care interventions have been articulated by many international organizations, including iodization of salt, use of oral rehydration therapy (ort) for diarrheal diseases, vitamin a supplementation for all children, expanded programs of immunization, and others that have the potential for saving hundreds of thousands of lives yearly at low cost. in developed countries, health promotions targeted to reduce accidents and risk factors such as smoking, high-fat diets, and lack of exercise for cardiovascular diseases are low-cost public health interventions that save lives and reduce the use of hospital care. targeting specific diseases is essential for efforts to control tb or eradicate polio, but at the same time, development of a comprehensive primary care infrastructure is equally or even more important than the single-disease approach. some disease entities such as hiv/aids attract donor funding more readily than basic infrastructure services such as immunization, and this can sometimes be detrimental to addressing the overall health needs of the population and other neglected but also important diseases. the risk approach selects population groups on the basis of risk and helps to determine interventional priorities to reduce morbidity and mortality. the measure of health risk is taken as a proxy for need, so that the risk approach provides something for all, but more for those in need, in proportion to that need. in epidemiological terms, these are people with higher relative risk or attributed risk. some groups in the general population are at higher risk than others for specific conditions. the expanded programme on immunization (epi), control of diarrhoeal diseases (cdd), and acute respiratory disease (ard) programs of the who are risk approaches to tackling fundamental public health problems of children in developing countries. public health places considerable emphasis on maternal and child health because these are vulnerable periods in life for specific health problems. pregnancy care is based on a basic level of care for all, with continuous assessment of risk factors that require a higher intensity of follow-up. prenatal care helps to identify factors that increase the risk for the pregnant woman or her fetus/newborn. efforts directed towards these special risk groups have the potential to reduce morbidity and mortality. high-risk case identification, assessment, and management are vital to a successful maternal care program. similarly, routine infant care is designed not only to promote the health of infants, but also to find the earliest possible indications of deviation and the need for further assessment and intervention to prevent a worsening of the condition. low birth-weight babies are at greater risk for many short-and long-term hazards and should be given special treatment. all babies are routinely screened for birth defects or congenital conditions such as hypothyroidism, phenylketonuria, and other metabolic and hematological diseases. screening must be followed by investigating and treating those found to have a clinical deficiency. this is an important element of infant care because infancy itself is a risk factor. as will be discussed in chapters and and others, epidemiology has come to focus on the risk approach with screening based on known genetic, social, nutritional, environmental, occupational, behavioral, or other factors contributing to the risk for disease. the risk approach has the advantage of specificity and is often used to initiate new programs directed at special categories of need. this approach can lead to narrow and somewhat rigid programs that may be difficult to integrate into a more general or comprehensive approach, but until universal programs can be achieved, selective targeted approaches are justifiable. indeed, even with universal health coverage, it is still important to address the health needs or issues of groups at special risk. working to achieve defined targets means making difficult choices. the supply and utilization of some services will limit availability for other services. there is an interaction, sometimes positive, sometimes negative, between competing needs and the health status of a population. public health identifies needs by measuring and comparing the incidence or prevalence of the condition in a defined population with that in other comparable population groups and defines targets to reduce or eliminate the risk of disease. it determines ways of intervening in the natural epidemiology of the disease, and develops a program to reduce or even eliminate the disease. it also assesses the outcomes in terms of reduced morbidity and mortality, as well as the economic justification in cost-effectiveness analysis to establish its value in health priorities. because of the interdependence of health services, as well as the total financial burden of health care, it is essential to look at the costs of providing health care, and how resources should be allocated to achieve the best results possible. health economics has become a fundamental methodology in policy determination. the costs of health care, the supply of services, the needs for health care or other health-promoting interventions, and effective means of using resources to meet goals are fundamental in the new public health. it is possible to err widely in health planning if one set of factors is overemphasized or underemphasized. excessive supply of one service diminishes the availability of resources for other needed investments in health. if diseases are not prevented or their sequelae not well managed, patients must use costly health care services and are unable to perform their normal social functions such as learning at school or performing at work. lack of investment in health promotion and primary prevention creates a larger reliance on institutional care, driving health costs upwards, and restricting flexibility in meeting patients' needs. the interaction of supply and demand for health services is an important determinant of the political economy of health care. health and its place in national priorities are determined by the social-political philosophy and resource allocation of a government. the case for action, or the justification for a public health intervention, is a complex of epidemiological, economic, and public policy factors (table . ). each disease or group of diseases requires its own case for action. the justification for public health intervention requires sufficient evidence of the incidence and prevalence of the disease (see chapter ). evidence-based public health takes into account the effectiveness and safety of an intervention; risk factors; safe means at hand to intervene; the human, social, and economic cost of the disease; political factors; and a policy decision as to the priority of the problem. this often depends on subjective factors, such as the guiding philosophy of the health system and the way it allocates resources. some interventions are so well established that no new justification is required to make the case, and the only question is how to do it most effectively. for example, infant vaccination is a cost-effective and cost-beneficial program for the protection of the individual child and the population as a whole. whether provided as a public service or as a clinical preventive measure by a private medical practitioner, it is in the interest of public health that all children be immunized. an outbreak of diarrheal disease in a kindergarten presents an obvious case for action, and a public health system must respond on an emergency basis, with selection of the most suitable mode of intervention. the considerations in developing a case for action are outlined above. need is based on clinical and epidemiological evidence, but also on the importance of an intervention in the eyes of the public. the technology available, its effectiveness and safety, and accumulated experience are important in the equation, as are the acceptability and affordability of appropriate interventions. the precedents for use of an intervention are also important. on epidemiological evidence, if the preventive practice has been seen to provide reduction in risk for the individual and for the population, then there is good reason to implement it. the costs, risks and benefits must be examined as part of the justification to help in the selection of health priorities. health systems research examines the efficiency of health care and promotes improved efficiency and effective use of resources. this is a vital function in determining how best to use resources and meet current health needs. past emphasis on hospital care at the expense of less development of primary care and prevention is still a common issue, particularly in former soviet and developing countries, where a high percentage of total health expenditure goes to acute hospital care with long length of stay, with smaller allocation to preventive and community health care. the result of this imbalance is high mortality from preventable diseases. new drugs, vaccines, and medical equipment are continually becoming available, and each new addition needs to be examined among the national health priorities. sometimes, owing to cost, a country cannot afford to add a new vaccine to the routine. however, when there is good evidence for efficacy and safety of new vaccines, drugs, diagnostic methods or other innovations, it could be applied for those at greatest risk. although there are ethical issues involved, it may be necessary to advise parents or family members to purchase the vaccine independently. clearly, recommending individual purchase of a vaccine is counter to the principle of equity and solidarity, benefiting middleclass families, and providing a poor basis of data for evaluation of the vaccine and its target disease. on the other hand, failure to advise parents of potential benefits to their children creates other ethical problems, but may increase public pressure and insurance system acceptance of new methods, e.g., varicella and hpv vaccines. mass screening programs involving complete physical examinations have not been found to be cost-effective or to significantly reduce disease. in the s and s, routine general health examinations were promoted as an effective method of finding disease early. since the late s, a selective and specific approach to screening has become widely accepted. this involves defining risk categories for specific diseases and bearing in mind the potential for remedial action. early case finding of colon cancer by routine fecal blood testing and colonoscopy has been found to be effective, and pap smear testing to discover cancer of the cervix is timed according to risk category. screening for colorectal cancer is essential for modern health programs and has been adopted by most industrialized countries. outreach programs by visits, telephones, emails or other modern methods of communication are important to contact non-attenders to promote utilization, and have been shown to increase compliance with proven effective measures. these programs are important for screening, follow-up, and maintenance of treatment for hypertension, diabetes, and other conditions requiring long-term management. screening technology is changing and often the subject of intense debate as such programs are costly and their cost-effectiveness is an important matter for policy making: screening for lung cancer is becoming a feasible and effective matter for high-risk groups, whereas breast cancer screening frequency is now in dispute; while nanotechnology and bioengineering promises new methods for cancer screening. the factor of contribution to quality of life should be considered. a vaccine for varicella is justified partly for the prevention of deaths or illness from chickenpox. a stronger the right to health public expectation and social norms argument is often based on the fact that this is a disease that causes moderate illness in children for up to weeks and may require parents to stay home with the child, resulting in economic loss to the parent and society. the fact that this vaccination prevents the occurrence of herpes zoster or shingles later in life may also be a justification. widespread adoption of hepatitis b vaccine is justified on the grounds that it prevents cancer of the liver, liver cirrhosis, and hepatic failure in a high percentage of the population affected. how many cases of a disease are enough to justify an intervention? one or several cases of some diseases, such as poliomyelitis, may be considered an epidemic in that each case constitutes or is an indicator of a wider threat. a single case of polio suggests that another persons are infected but have not developed a recognized clinical condition. such a case constitutes a public health emergency, and forceful organization to meet a crisis is needed. current standards are such that even one case of measles imported into a population free of the disease may cause a large outbreak, as occurred in the uk, france, and israel during through , by contacts on an aircraft, at family gatherings, or even in medical settings. a measles epidemic indicates a failure of public health policy and practice. screening for some cancers, such as cervix and colon, is cost effective. screening of all newborns for congenital disorders is important because each case discovered early and treated effectively saves a lifetime of care for serious disability. assessing a public health intervention to prevent the disease or reduce its impact requires measurement of the disease in the population and its economic impact. there is no simple formula to justify a particular intervention, but the cost-benefit approach is now commonly required to make such a case for action. sometimes public opinion and political leadership may oppose the views of the professional community, or may impose limitations of policy or funds that prevent its implementation. conversely, professional groups may press for additional resources that compete for limited resources available to provide other needed health activities. both the professionals of the health system and the general public need full access to health-related information to take part in such debates in a constructive way. to maintain progress, a system must examine new technologies and justify their adoption or rejection (see chapter ). the association between health and political issues was emphasized by european innovators such as rudolf virchow (and in great britain by edwin chadwick; see chapter ) in the mid-nineteenth century, when the conditions of the working population were such that epidemic diseases were rife and mortality was high, especially in the crowded slums of the industrial revolution. the same observations led bismarck in germany to introduce early forms of social insurance for the health of workers and their families in the s, and to britain's national health insurance, also for workers and families. the role of government in providing universal access to health care was a struggle in individual countries during the twentieth century and lasting into the second decade of the twenty-first century (e.g. president obama's affordable health care act of ). as the concept of public health has evolved, and the cost effectiveness of medical care has improved through scientific and technological advances, societies have identified health as a legitimate area of activity for collective bargaining and government. with this process, the need to manage health care resources has become more clearly defined as a public responsibility. in industrialized countries, each with very different political make-up, national responsibility for universal access to health has become part of the social ethos. with that, the financing and managing of health services have developed into part of a broad concept of public health, and economics, planning, and management have come to be part of the new public health (discussed in chapters - ). social, ethical, and political philosophies have profound effects on policy decisions including allocation of public monies and resources. investment in public health is now recognized as an integral part of socioeconomic development. governments are major suppliers of funds and leadership in health infrastructure development, provision of health services, and health payment systems. they also play a central role in the development of health promotion and regulation of the environment, food, and drugs essential for community health. in liberal social democracies, the individual is deemed to have a right to health care. the state accepts responsibility to ensure availability, accessibility, and quality of care. in many developed countries, government has also taken responsibility to arrange funding and services that are equitably accessible and of high quality. health care financing may involve taxation, allocation, or special mandatory requirements on employers to pay for health insurance. services may be provided by a state-financed and -regulated service or through ngos and/or private service mechanisms. these systems allocate between percent and percent of gross national product (gnp) to health services, with some governments funding over percent of health expenditure; for example, canada and the uk. in communist states, the state organizes all aspects of health care with the philosophy that every citizen is entitled to equity in access to health services. the state health system manages research, staff training, and service delivery, even if operational aspects are decentralized to local health authorities. this model applied primarily to the soviet model of health services. these systems, except for cuba, placed financing of health low on the national priority, with funding less than percent of gnp. in the shift to market economies in the s, some former socialist countries, such as russia, are struggling with poor health status and a difficult shift from a strongly centralized health system to a decentralized system with diffusion of powers and responsibilities. promotion of market concepts in former soviet countries has reduced access to care and created a serious dilemma for their governments. former colonial countries, independent since the s and s, largely carried on the governmental health structures established in the colonial times. most developing countries have given health a relatively low place in budgetary allotment, with expenditures under percent of gnp. since the s, there has been a trend in developing countries towards decentralization of health services and greater roles for ngos, and the development of health insurance. some countries, influenced by medical concepts of their former colonial master countries, fostered the development of specialty medicine in the major centers with little emphasis on the rural majority population. soviet influence in many ex-colonial countries promoted state-operated systems. the who promoted primary care, but the allocations favored city-based specialty care. israel, as an ex-colony, adapted british ideas of public health together with central european sick funds and maternal and child health as major streams of development until the mid- s. a growing new conservatism in the s and s in the industrialized countries is a restatement of old values in which market economics and individualistic social values are placed above concepts of the "common good" of liberalism and socialism in its various forms. in the more extreme forms of this concept, the individual is responsible for his or her own health, including payment, and has a choice of health care providers that will respond with high-quality personalized care. market forces, meaning competition in financing and provision of health services with rationing of services, based on fees or private insurance and willingness and ability to pay, have become part of the ideology of the new conservatism. it is assumed that the patient (i.e., the consumer) will select the best service for his or her need, while the provider best able to meet consumer expectations will thrive. in its purest form, the state has no role in providing or financing of health services except those directly related to community protection and promotion of a healthful environment without interfering with individual choices. the state ensures that there are sufficient health care providers and allows market forces to determine the prices and distribution of services with minimal regulation. the usa retains this orientation in a highly modified form, with percent of the population covered by some form of private or public insurance systems (see chapters and ). modified market forces in health care are part of health reforms in many countries as they seek not only to ensure quality health care for all but also to constrain costs. a free market in health care is costly and ultimately inefficient because it encourages inflation of provider incomes or budgets and increasing utilization of highly technical services. further, even in the most free market societies, the economy of health care is highly influenced by many factors outside the control of the consumer and provider. the total national health expenditure in the usa rose rapidly until reaching over . percent of gross domestic product (gdp) in , the highest of any country, despite serious deficiencies for those without any or with very inadequate health insurance (in total more than percent of the population). this figure compares to some . percent of gdp in canada, which has universal health insurance under public administration. following the defeat of president clinton's national health program, the conservative congress and the business community took steps to expand managed care in order to control costs, resulting in a revolution in health care in the usa (see chapters and ). in the - decade health expenditure in the usa is expected to rise to . percent of gdp, partly owing to increased population coverage with implementation of the ppaca (obamacare). reforms are being implemented in many "socialized" health systems. these may be through incentives to promote achievement of performance indicators, such as full immunization coverage. others are using control of supply, such as hospital beds or licensed physicians, as methods of reducing overutilization of services that generates increasing costs. market mechanisms in health are aimed not only at the individual but also at the provider. incentive payment systems must work to protect the patient's legitimate needs, and conversely incentives that might reduce quality of care should be avoided. fee-for-service promotes high rates of services such as surgery. increasing private practice and user fees can adversely affect middle-and low-income groups, as well as employers, by raising the costs of health insurance. managed care systems, with restraints on fee-for-service medical practice, have emerged as a positive response to the market approach. incentive systems in payments for services may be altered by government or insurance agencies in order to promote rational use of services, such as reduction of hospital stays. the free market approach is affecting planning of health insurance systems in previously highly centralized health systems in developing countries as well as the redevelopment of health systems in former soviet countries. despite political differences, reform of health systems has become a common factor in virtually all health systems since the s, as each government searches for costeffectiveness, quality of care, and universality of coverage. the new paradigm of health care reform sees the convergence of different systems to common principles. national responsibility for health goals and health promotion leads to national financing of health care with regional and managed care systems. most developed countries have long since adopted national health insurance or service systems. some governments may, as in the usa, insure only the highest risk groups such as the elderly and the poor, leaving the working and middle classes to seek private insurers. the nature and direction of health care reform affecting coverage of the population are of central importance in the new public health because of its effects on allocation of resources and on the health of the population. the effects of the economic crisis in the usa are being felt worldwide. while the downturn has largely occurred in wealthier nations, the poor in low-income countries will be among those affected. past economic downturns have been followed by substantial drops in foreign aid to developing countries. as public health gained from sanitary and other control measures for infectious diseases, along with mother and child care, nutrition, and environmental and occupational health, it also gained strength and applicability from advances in the social and behavioral sciences. social darwinism, a political philosophy that assumed "survival of the fittest" and no intervention of the sate to alleviate this assumption, was popular in the early nineteenth century but became unacceptable in industrialized countries, which adopted social policies to alleviate the worst conditions of poverty, unemployment, poor education, and other societal ills. the political approach to focusing on health and poverty is associated with jeremy bentham in britain in the late eighteenth century, who promoted social and political reform and "the greatest good for the greatest number", or utilitarianism. rudolf virchow, an eminent pathologist and a leader in recognizing ill-health and poverty as cause and effect, called for political action to create better conditions for the poor and working-class population. the struggle for a social contract was promoted by pioneer reformists such as edwin chadwick (general report on the sanitary condition of the labouring population of great britain, ), who later became the first head of the board of health in britain, and lemuel shattuck (report of a general plan for the promotion of public and personal health, ) . shattuck was the organizer and first president of the american statistical association. the social sciences have become fundamental to public health, with a range of disciplines including vital statistics and demography (seventeenth century), economics and politics (nineteenth century), sociology (twentieth century), history, anthropology, and others, which provide collectively important elements of epidemiology of crucial significance for survey methods and qualitative research (see chapter ). these advances contributed greatly to the development of methods of studying diseases and risk factors in a population and are still highly relevant to addressing inequalities in health. individuals in good health are better able to study and learn, and be more productive in their work. improvements in the standard of living have long been known to contribute to improved public health; however, the converse has not always been recognized. investment in health care was not considered a high priority in many countries where economic considerations directed investment to the "productive" sectors such as manufacturing and large-scale infrastructure projects, such as hydroelectric dams. whether health is a contributor to economic development or a drain on societies' resources has been a fundamental debate between socially and market-oriented advocates. classic economic theory, both free enterprise and communist, has tended to regard health as a drain on economies, distracting investment needed for economic growth. as a result, in many countries health has been given low priority in budgetary allocation, even when the major source of financing is governmental. this belief among economists and banking institutions prevented loans for health development on the grounds that such funds should focus on creating jobs and better incomes, before investing in health infrastructure. consequently, the development of health care has been hampered. a socially oriented approach sees investment in health as necessary for the protection and development of "human capital", just as investment in education is needed for the long-term benefit of the economy of a country. in , the world bank's world development report: investing in health articulated a new approach to economics in which health, along with education and social development, is seen as an essential precondition for and contributor to economic development. while many in the health field have long recognized the importance of health for social and economic improvement, its adoption by leading international development banking may mark a turning point for investment in developing nations, so that health may be a contender for increased development loans. the concept of an essential package of services discussed in that report establishes priorities in low-and middle-income countries for efficient use of resources based on the burden of disease and cost-effectiveness analysis of services. it includes both preventive and curative services targeted to specific health problems. it also recommends support for comprehensive primary care, such as for children, and infrastructure development including maternity and hospital care, medical and nursing outreach services, and community action to improve sanitation and safe water supplies. reorientation of government spending on health is increasingly being adopted, as in the uk, to improve equity in access for the poor and other neglected sectors or regions of society with added funding for relatively deprived areas to improve primary care services. differential capitation funding as a form of affirmative action to provide for highneeds populations is a useful concept in public health terms to address the inequities still prevalent in many countries. as medical care has gradually become more involved in prevention, and as it has moved into the era of managed care, the gap between public health and clinical medicine has narrowed. as noted above, many countries are engaged in reforms in their health care systems. the motivation is largely derived from the need for cost containment, but also to extend health care coverage to underserved parts of the population. countries without universal health care still have serious inequities in distribution of or access to services, and may seek reform to reduce those inequities, perhaps under political pressures to improve the provision of services. incentives for reform are needed to address regional inequities, and preserving or developing universal access and quality of care, but also on inequities in health between the rich and the poor countries and within even the wealthy countries. in some settings, a health system may fail to keep pace with developments in prevention and in clinical medicine. some countries have overdeveloped medical and hospital care, neglecting important initiatives to reduce the risk of disease. the process of reform requires setting standards to measure health status and the balance of services to optimize health. a health service can set a target of immunizing percent of infants with a national immunization schedule, but requires a system to monitor performance and incentives for changes. a health system may also have failed to adapt to changing needs of the population through lack, or misuse, of health information and monitoring systems. as a result, the system may err seriously in its allocation of resources, with excessive emphasis on hospital care and insufficient attention to primary and preventive care. all health services should have mechanisms for correctly gathering and analyzing needed data for monitoring the incidence of disease and other health indicators, such as hospital utilization, ambulatory care, and preventive care patterns. for example, the uk's nhs periodically undertakes a restructuring process of parts of the system to improve the efficiency of service. this involves organizational changes and decentralization with regional allocation of resources (see chapter ). health systems are under pressures of changing demographic and epidemiological patterns as well as public expectations, rising costs of new technology, financing, and organizational change. new problems must be continually addressed with selection of priority issues and the most effective methods chosen. reforms may create unanticipated problems, such as professional or public dissatisfaction, which must be evaluated, monitored, and addressed as part of the evolution of public health. literacy, freedom of the press, and increasing public concern for social and health issues have contributed to the development of public health. the british medical community lobbied for restrictions on the sale of gin in the s in order to reduce the damage that it caused to the working class. in the late eighteenth and the nineteenth centuries, reforms in society and sanitation were largely the result of strongly organized advocacy groups influencing public opinion through the press. such pressure stimulated governments to act in regulating the working conditions of mines and factories. abolition of the slave trade and its suppression by the british navy in the early nineteenth century resulted from successful advocacy groups and their effects on public opinion through the press. vaccination against smallpox was promoted by privately organized citizen groups, until later taken up by local and national government authorities. advocacy consists of activities of individuals or groups publicly pleading for, supporting, espousing, or recommending a cause or course of action. the advocacy role of reform movements in the nineteenth century was the basis of the development of modern organized public health. campaigns ranged from the reform of mental hospitals, nutrition for sailors to prevent scurvy and beriberi, and labor laws to improve working conditions for women and children in particular, to the promotion of universal education and improved living conditions for the working population. reforms on these and other issues resulted from the stirring of the public consciousness by advocacy groups and the public media, all of which generated political decisions in parliaments (box . ). such reforms were in large part motivated by fear of revolution throughout europe in the mid-nineteenth century and the early part of the twentieth century. trade unions, and before them medieval guilds, fought to improve hours, safety, and conditions of work, as well as social and health benefits for their members. in the usa, collective bargaining through trade unions achieved wage increases and widespread coverage of the working population under voluntary health insurance. unions and some industries pioneered prepaid group practice, the predecessor of health maintenance organizations and managed care or the more recent acos (see chapters and ). through raising public consciousness on many issues, advocacy groups pressure governments to enact legislation to restrict smoking in public places, prohibit tobacco advertising, and mandate the use of bicycle helmets. advocacy groups play an important role in advancing health based on disease groups, such as cancer, multiple sclerosis, and thalassemia, or advancing health issues, such as the organizations promoting breastfeeding, environmental improvement, or smoking reduction. some organizations finance services or facilities not usually provided within insured health programs. such organizations, which can number in the hundreds in a country, advocate the importance of their special concern and play an important role in innovation and meeting community health needs. advocacy groups, including trade unions, professional groups, women's groups, self-help groups, and many others, focus on specific issues and have made major contributions to advancing the new public health. the history of public health is replete with pioneers whose discoveries led to strong opposition and sometimes violent rejection by conservative elements and vested interests in medical, public, or political circles. opposition to jennerian vaccination, the rejection of semmelweiss by colleagues in vienna, and the contemporary opposition to the work of great pioneers in public health such as pasteur, florence nightingale, and many others may deter or delay implementation of other innovators and new breakthroughs in preventing disease. although opposition to jenner's vaccination lasted well into the late nineteenth century in some areas, its supporters gradually gained ascendancy, ultimately leading to the global eradication of smallpox. these and other pioneers led the way to improved health, often after bitter controversy on topics later accepted and which, in retrospect, seem to be obvious. advocacy has sometimes had the support of the medical profession but elicited a slow response from public authorities. david marine of the cleveland clinic and david cowie, professor of pediatrics at the university of michigan, proposed the prevention of goiter by iodization of salt. marine carried out a series of studies in fish, and then in a controlled clinical trial among schoolgirls in - , with startlingly positive results in reducing the prevalence of goiter. cowie campaigned for the iodization of salt, with support from the medical profession. in , he convinced a private manufacturer to produce morton's iodized salt, which rapidly became popular throughout north america. similarly, iodized salt came to be used in many parts of europe, mostly without governmental support or legislation. iodine-deficiency disorders (idds) remain a widespread condition, estimated to have affected billion people worldwide in . the target of international eradication of idds by was set at the world summit for children in , and the who called for universal iodization of salt in . by , nearly percent of households in developing countries consumed adequately iodized salt. china and nigeria, have had great success in recent years with mandatory salt fortification in increasing iodization rates, in china from percent to percent in years. but the problem is not yet gone and even in europe there is inadequate standardization of iodine levels and population follow-up despite decades of work on the problem. professional organizations have contributed to promoting causes such as children's and women's health, and environmental and occupational health. the american academy of pediatrics has contributed to establishing and promoting high standards of care for infants and children in the usa, and to child health internationally. hospital accreditation has been used for decades in the usa, canada, and more recently in australia and the uk. it has helped to raise standards of health facilities and care by carrying out systematic peer review of hospitals, nursing homes, primary care facilities, and mental hospitals, as well as ambulatory care centers and public health agencies (see chapter ). public health needs to be aware of negative advocacy, sometimes based on professional conservatism or economic self-interest. professional organizations can also serve as advocates of the status quo in the face of change. opposition by the american medical association (ama) and the health insurance industry to national health insurance in the usa has been strong and successful for many decades. the passage of the ppaca has been achieved despite widespread political and public opposition, yet was sustained in the us supreme court and is gaining widening popular support as the added value to millions of formerly uninsured americans becomes clear. in some cases, the vested interest of one profession may block the legitimate development of others, such as when ophthalmologists lobbied successfully against the development of optometry, now widely accepted as a legitimate profession. political activism for reform in nineteenth-century britain led to banning and suppressing the slave trade, improvements in working conditions for miners and factory workers, and other major political reforms. in keeping with this tradition, samuel plimsoll ( - ), british member of parliament elected for derby in , conducted a solo campaign for the safety of seamen. his book, our seamen, described ships sent to sea so heavily laden with coal and iron that their decks were awash. seriously overloaded ships, deliberately sent to sea by unscrupulous owners, frequently capsized, drowning many crew members, with the owners collecting inflated insurance fees. overloading was the major cause of wrecks and thousands of deaths in the british shipping industry. plimsoll pleaded for mandatory load-line certificate markers to be issued to each ship to prevent any ships putting to sea when the marker was not clearly visible. powerful shipping interests fought him every inch of the way, but he succeeded in having a royal commission established, leading to an act of parliament mandating the "plimsoll line", the safe carrying capacity of cargo ships. this regulation was adopted by the us bureau of shipping as the load line act in and is now standard practice worldwide. jenner's discovery of vaccination with cowpox to prevent smallpox was adopted rapidly and widely. however, intense opposition by organized groups of antivaccinationists, often led by those opposed to government intervention in health issues and supported by doctors with lucrative variolation practices, delayed the implementation of smallpox vaccination for many decades. ultimately, smallpox was eradicated in , owing to a global campaign initiated by the who. opposition to legislated restrictions on private ownership of assault weapons and handguns is intense in the usa, led by well-organized, well-funded, and politically powerful lobby groups, despite the amount of morbidity and mortality due to gun-associated violent acts (see chapter ). fluoridation of drinking water is the most effective public health measure for preventing dental caries, but it is still widely opposed, and in some places the legislation has been rescinded even after implementation, by wellorganized antifluoridation campaigns. opposition to fluoridation of community water supplies is widespread, and effective lobbying internationally has slowed but has not stopped progress (see chapter ). despite the life-saving value of immunization, opposition still exists in and harms public health protection. opposition has slowed progress in poliomyelitis eradication; for example, radical islamists killed polio workers in northern nigeria in , one of the last three countries with endemic poliomyelitis. resistance to immunization in the s has resulted in the recurrence of pertussis and diphtheria and a very large epidemic of measles across western europe, including the uk, with further spread to the western hemisphere in - (see chapter ). progress may be blocked where all decisions are made in closed discussions, not subject to open scrutiny and debate. public health personnel working in the civil service of organized systems of government may not be at liberty to promote public health causes. however, professional organizations may then serve as forums for the essential professional and public debate needed for progress in the field. professional organizations such as the apha provide effective lobbying for the interests of public health programs and can have an important impact on public policy. in mid- , efforts by the secretary of health and human services in the usa brought together leaders of public health with representatives of the ama and academic medical centers to try to find areas of common interest and willingness to promote the health of the population. in europe too, increasing cooperation between public health organizations is stimulating debate on issues of transnational importance across the region, which, for example, has a wide diversity of standards on immunization practices and food policies. public advocacy has played an especially important role in focusing attention on ecological issues (box . ). in , greenpeace, an international environmental activist group, fought to prevent the dumping of an oil rig in the north sea and forced a major oil company to find another solution that would be less damaging to the environment. an explosion on an oil rig in the gulf of mexico in led to enormous ecological and economic damage as well as loss of life. damages levied on the responsible company (british petroleum) amount to some $ . billion dollars and several criminal negligence charges are pending. greenpeace also continued its efforts to stop the renewal of testing of atomic bombs by france in the south pacific. international protests led to the cessation of almost all testing of nuclear weapons. international concern over global warming has led to growing efforts to stem the tide of air pollution from fossil fuels, coal-burning electrical production, and other manifestations of carbon dioxide and toxic contamination of the environment. progress is far from certain as newly enriched countries such as china and india follow the rising consumption patterns of western countries. public advocacy and rejection of wanton destruction of the global ecology may be the only way to prod consumers, governments, and corporate entities such as the energy and transportation industries to change direction. the pace of change from fossil fuels is slow but has captured public attention, and private companies are seeking more fuel efficiency in vehicles and electrical power production, mainly though the use of natural gas instead of fuel oil and coal for electricity production or better still by wind and solar energy. the search for "green solutions" to the global warming crisis has become increasingly dynamic, with governments, the private sector, and the general public keenly aware of the importance of the effort and the dangers of failure. in the latter part of the twentieth century and the early twenty-first century, prominent international personalities and entertainers have taken up causes such as the removal of land mines in war-torn countries, illiteracy in disadvantaged advocacy is a function in public health that has been important in promoting advances in the field, and one that sometimes places the advocate in conflict with established patterns and organizations. one of the classic descriptions of this function is in henrik ibsen's play an enemy of the people, in which the hero, a young doctor, thomas stockmann, discovers that the water in his community is contaminated. this knowledge is suppressed by the town's leadership, led by his brother the mayor, because it would adversely affect plans to develop a tourist industry of baths in their small norwegian town in the late nineteenth century. the young doctor is taunted and abused by the townspeople and driven from the town, having been declared an "enemy of the people" and a potential risk. the allegory is a tribute to the man of principle who stands against the hysteria of the crowd. the term also took on a far more sinister and dangerous meaning in george orwell's novel and in totalitarian regimes of the s to the present time. populations, and funding for antiretroviral drugs for african countries to reduce maternal-fetal transmission of hiv and to provide care for the large numbers of cases of aids devastating many countries of sub-saharan africa. rotary international has played a key role in polio eradication efforts globally. the public-private consortium global alliance for vaccines and immunization (gavi) has been instrumental in promoting immunization in recent years, with participation by the who, unicef, the world bank, the gates foundation, vaccine manufacturers, and others. this has had an important impact on extending immunization to protect and save the lives of millions of children in deprived countries not yet able to provide fundamental prevention programs such as immunization at adequate levels. gavi has brought vaccines to low-income countries around the world, such as rotavirus vaccine, pentavalent vaccine in myanmar, and pneumococcal vaccine for children in countries in sub-saharan africa, including dr congo. the bill & melinda gates foundation pledged us $ million in to establish gavi, with us $ million per year and us $ billion in to promote the decade of vaccines. international conferences help to create a worldwide climate of advocacy for health issues. international sanitary conferences in the nineteenth century were convened in response to the cholera epidemics. international conferences continue in the twenty-first century to serve as venues for advocacy on a global scale, bringing forward issues in public health that are beyond the scope of individual nations. the who, unicef, and other international organizations perform this role on a continuing basis (see chapter ). criticisms of this approach have focused on the lack of similar effort or donors to address ncds, weak public health infrastructure, and that this frees national governments from responsibility to care for their own children. no one can question, however, that this kind of endeavor has saved countless lives and needs the backing of other aid donors and national government participation. consumerism is a movement that promotes the interests of the purchaser of goods or services. in the s, a new form of consumer advocacy emerged from the civil rights and antiwar movement in the usa. concern was focused on the environment, occupational health, and the rights of the consumer. rachel carson stimulated concern by dramatizing the effects of ddt on wildlife and the environment but inadvertently jeopardized anti-malarial efforts in many countries. this period gave rise to environmental advocacy efforts worldwide, and a political movement, the greens, in western europe. ralph nader showed the power of the advocate or "whistle-blower" who publicizes health hazards to stimulate active public debate on a host of issues related to the public well-being. nader, a consumer advocate lawyer, developed a strategy for fighting against business and government activities and products which endangered public health and safety. his book unsafe at any speed took issue with the us automobile industry for emphasizing profit and style over safety, and led to the enactment of the national traffic and motor safety act of , establishing safety standards for new cars. this was followed by a series of enactments including design and emission standards and seat-belt regulations. nader's work continues to promote consumer interests in a wide variety of fields, including the meat and poultry industries, and coal mining, and promotes greater government regulatory powers regarding pesticide usage, food additives, consumer protection laws, rights to knowledge of contents, and safety standards. consumerism has become an integral part of free market economies, and the educated consumer does influence the quality, content, and price of products. greater awareness of nutrition in health has influenced food manufacturers to improve packaging, content labeling, enrichment with vitamins and minerals, and advertisement to promote those values. low-fat dietary products are available because of an increasingly sophisticated public concerned over dietary factors in cardiovascular diseases. the same process occurred in safe toys and clothing for children, automobile safety features such as mandatory use of car seats for infants, and other innovations that quickly became industry standards in the industrialized world. dangerous practices such as the use of lead paint in toys and melamine contamination of milk products from china capture the public attention quickly and remind public health authorities of the importance of continuous alertness to potential hazards. consumerism can also be exploited by pharmaceutical companies with negative impacts on the health system, especially in the advertising of health products which leads to unnecessary visits to health providers and pressure for approval to obtain the product. the internet has provided people with access to a vast array of information and opinion, and to current literature otherwise unavailable because of the often inadequate library resources of medical and other health professionals. the very freedom of information the internet allows, however, also provides a vehicle for extremist and fringe groups to promote disinformation such as "vaccination causes autism, fluoridation causes cancer", which can cause considerable difficulties for basic public health programs or lead to self-diagnosis of conditions, with often disastrous consequences. advocacy and voluntarism go hand in hand. voluntarism takes many forms, including raising funds for the development of services or operating services needed in the community. it may take the form of fund-raising to build clinics or hospitals in the community, or to provide medical equipment for elderly or handicapped people; or retirees and teenagers working as hospital volunteers to provide services that are not available through paid staff, and to provide a sense of community caring for the sick in the best traditions of religious or municipal concerns. this can also be extended to prevention, as in support for immunization programs, assistance for the handicapped and elderly in transportation, meals-on-wheels, and many other services that may not be included in the "basket of services" provided by the state, health insurance, or public health services. community involvement can take many forms, and so can voluntarism. the pioneering role of women's organizations in promoting literacy, health services, and nutrition in north america during the latter part of the nineteenth and the early twentieth centuries profoundly affected the health of the population. the advocacy function is enhanced when an organization mobilizes voluntary activity and funds to promote changes or needed services, sometimes forcing official health agencies or insurance systems to revise their attitudes and programs to meet these needs. by the early s, canada's system of federally supported provincial health insurance plans covered all of the country. the federal minister of health, marc lalonde, initiated a review of the national health situation, in view of concern over the rapidly increasing costs of health care. this led to articulation of the "health field concept" in , which defined health as a result of four major factors: human biology, environment, behavior, and health care organization (box . ). lifestyle and environmental factors were seen as important contributors to the morbidity and mortality in modern societies. this concept gained wide acceptance, promoting new initiatives that emphasized health promotion in response to environmental and lifestyle factors. conversely, reliance primarily on medical care to solve all health problems could be counterproductive. this concept was a fundamental contributor to the idea of health promotion later articulated in the ottawa declaration, discussed below. the health field concept came at a time when many epidemiological studies were identifying risk factors for cardiovascular diseases and cancers that related to personal habits, such as diet, exercise, and smoking. the concept advocated that public policy needed to address individual lifestyle as part of the overall effort to improve health status. as a result, the canadian federal government established health promotion as a new activity. this quickly spread to many other jurisdictions and gained wide acceptance in many industrialized countries. concern was expressed that this concept could become a justification for a "blame the victim" approach, in which those ill with a disease related to personal lifestyles, such as smokers or aids patients, are seen as having chosen to contract the disease. such a patient might then be considered not to be entitled to all benefits of insurance or care that others may receive. the result may be a restrictive approach to care and treatment that would be unethical in the public health tradition and probably illegal in western jurisprudence. this concept was also used to justify withdrawal from federal commitments in cost sharing and escape from facing controversial health reform in the national health insurance program. during the s and s, outspoken critics of health care systems, such as ivan illytch, questioned the value of medical care for the health of the public. this became a widely discussed, somewhat nihilistic, view towards medical care, and was influential in promoting skepticism regarding the value of the biomedical mode of health care, and antagonism towards the medical profession. in , thomas mckeown presented a historicalepidemiological analysis showing that up to the s, medical care had only a limited impact on mortality rates, although improvements in surgery and obstetrics were notable. he showed that crude death rates in england averaged about per population from to , declining steeply to per in , per in , and per in , when medical care became truly effective. mckeown concluded that much of the improvement in health status over the past several centuries was due to reduced mortality from infectious diseases. this he related to limitation of family size, increased food supplies, improved nutrition and sanitation, specific preventive and therapeutic measures, and overall gains in quality of life for growing elements of the population. he cautioned against placing excessive reliance for health on medical care, much of which was of unproved effectiveness. this skepticism of the biomedical model of health care was part of wider antiestablishment feelings of the s and s in north america. in , milton roemer pointed out that the advent of vaccines, antibiotics, antihypertensives, and other medications contributed to great improvements in infant and child care, and in the management of infectious diseases, hypertension, diabetes, and other conditions. therapeutic gains continue to arrive from teaching centers around the world. vaccine, pharmaceutical, and diagnostic equipment manufacturers continue to provide important innovations that have major benefits, but also raise the cost of health care. the latter issue is one which has stimulated the search for reforms, and search for lower cost technologies such as in treatment of hepatitis c patients, a huge international public health issue. the value of medical care to public health and vice versa has not always been clear, either to public health personnel or to clinicians. the achievements of modern public health in controlling infectious diseases, and even more so in reducing the mortality and morbidity associated with chronic diseases such as stroke and chd, were in reality a shared achievement between clinical medicine and public health (see chapter ). preventive medicine has become part of all medical practice, with disease prevention through early diagnosis and health promotion through individual and community-focused activities. risk factor evaluation determines appropriate screening and individual and community-based interventions. medical care is crucial in controlling hypertension and in reducing the complications and mortality from chd. new modalities of treatment are reducing death rates from first time acute myocardial infarctions. better management of diabetes prevents the early onset of complications. at the same time, the contribution of public health to improving outcomes of medical care is equally important. control of the vaccine-preventable diseases, improved nutrition, and preparation for motherhood contribute to improved maternal and infant outcomes. promotions of reduced exposure to risk factors for chronic disease are a task shared by public health and clinical medical services. both clinical medicine and public health contribute to improved health status. they are interdependent and rely on funding systems for recognition as part of the new public health. during the s, many new management concepts emerged in the business community, such as "management by objective", a concept developed by peter drucker at general motors, with variants such as "zero-based budgeting" developed in the us department of defense (see chapter ). they focused the activities of an organization and its budget on targets, rather than on previous allocation of resources. these concepts were applied in other spheres, but they influenced thinking in health, whose professionals were seeking new ways to approach health planning. the logical application was to define health targets and to promote the efficient use of resources to achieve those targets. this occurred in the usa and soon afterwards in the who european region. in both cases, a wide-scale process of discussion and consensus building was used before reaching definitive targets. this process contributed to the adoption of the targets by many countries in europe as well as by states and many professional and consumer organizations. the usa developed national health objectives in for the year and subsequently for the year , with monitoring of progress in their achievement and development of further targets for and now for . beginning in , state health profiles are prepared by the epidemiology program office of the centers for disease control and prevention based on health indicators recommended by a consensus panel representing public health associations and organizations. the eight mdgs adopted by the un in include halving extreme poverty, reducing child mortality by twothirds, improving maternal health, halting the spread of hiv/aids, malaria, and other diseases, and providing universal primary education, all by the target date of . the mdgs form a common blueprint agreed to by all countries and the world's leading development institutions. the process has galvanized unprecedented efforts to meet the needs of the world's poorest, yet reviews of progress indicate that most developing nations will not meet the targets at current rates of progress. the united nations development programme (undp) global partnership for development report on the mdgs states that if the national development strategies and initiatives are supported by international development partners, the goals can be achieved by . the mdgs were adopted by over nations and provided guidance for national policies and for international aid agencies. the focus was on middle-and low-income countries and their achievements have been considerable but variable (see box . and chapter ) . as of july , extreme poverty was falling in every region, the poverty reduction target had been met, the world had met the target of halving the proportion of people without access to improved sources of water, and the world had achieved parity in primary education between girls and boys. further progress will require sustained political commitment to develop the primary care infrastructure: improved reporting and epidemiological monitoring, consultative mechanisms, and consensus by international agencies, national governments, and non-governmental agencies. the achievement of the targets will also require sustained international support and national commitment with all the difficulties of a time of economic recession. nevertheless, defining a target is crucial to the process. there are encouraging signs that national governments are influenced by the general movement to place greater emphasis on resource allocation and planning on primary care to achieve internationally recognized goals and targets. the successful elimination of smallpox, rising immunization coverage in the developing countries, and increasing implementation of salt iodization have shown that such goals are achievable. while the usa has not succeeded in developing universal health care access, it has a strong tradition of public health and health advocacy. federal, state, and local health authorities have worked out cooperative arrangements for financing and supervising public health and other services. with growing recognition in the s that medical services alone would not achieve better health results, health policy leadership in the federal government formulated a new approach, in the form of developing specific health targets for the nation. in , the surgeon general of the usa published the report on health promotion and disease prevention (healthy people). this document set five overall health goals for each of the major age groups for the year , accompanied by specific health objectives. new targets for the year were developed in three broad areas: to increase healthy lifespans, to reduce health disparities, and to achieve access to preventive health care for all americans. these broad goals are supported by specific targets in health priority areas, each one divided into four major categories: health promotion, health protection, preventive services, and surveillance systems. this set the public health agenda on the basis of measurable indicators that can be assessed year by year. reduce child mortality -progress on child mortality is gaining momentum. the target is to reduce by two-thirds, between and , the under- -year-old mortality rate, from children of every dying to of every . child deaths are falling, but much more needs to be done in order to reach the development goal. revitalizing efforts against pneumonia and diarrhea, while bolstering nutrition, could save millions of children. l mdg . improve maternal health -maternal mortality has nearly halved since , but levels are far removed from the target. the targets for improving maternal health include reducing by three-quarters the maternal mortality ratio and achieve universal access to reproductive health. poverty and lack of education perpetuate high adolescent birth rates. inadequate funding for family planning is a major failure in fulfilling commitments to improving women's reproductive health. l mdg . combat hiv/aids, malaria, tuberculosis, and other diseases -more people than ever are living with hiv owing to fewer aids-related deaths and the continued large number of new infections. in , an estimated . million were living with hiv, up percent from . this persistent increase reflects the continued large number of new infections along with a significant expansion of access to lifesaving antiretroviral therapy, especially in more recent years. l mdg . ensure environmental sustainability -the unparalleled success of the montreal protocol shows that action on climate change is within grasp. the th anniversary of the montreal protocol on substances that deplete the ozone layer, in , had many achievements to celebrate. most notably, there has been a reduction of over percent in the consumption of ozone-depleting substances. further, because most of these substances are also potent greenhouse gases, the montreal protocol has contributed significantly to the protection of the global climate system. the reductions achieved to date leave hydrochlorofluorocarbons (hcfcs) as the largest group of substances remaining to be phased out. l mdg . a global partnership for development -core development aid fell in real terms for the first time in more than a decade, as donor countries faced fiscal constraints. in , net aid disbursements amounted to $ . billion, representing . percent of developed countries' combined national income. while constituting an increase in absolute dollars, this was a . percent drop in real terms over . if debt relief and humanitarian aid are excluded, bilateral aid for development programmes and projects fell by . percent in real terms. equitable and sustainable funding of health services. . developing human resources (educational programs for providers and managers based on the principles of the health for all policy). . research and knowledge: health programs based on scientific evidence. . mobilizing partners for health (engaging the media/ television/internet). . policies and strategies for health for all -national, targeted policies based on health for all. a - review has been commissioned by the european office of the who to assess inequalities in the social determinants of health. while health has improved there are still significant inequalities. factors include variance in local, regional, national, and global economic forces. the european union and the european region of who are both working on health targets for the year . there are competing demands in society for expenditure by the government, and therefore making the best use of resources -money and people -is an important objective. the uk has devolved many of the responsibilities to the constituent countries (england, wales, scotland, and northern ireland) within an overall national framework (box . ). of the health consequences of their decisions and to accept responsibility for health. health promotion policy combines diverse but complementary approaches, including legislation, fiscal measures, taxation, and organizational change. it is a coordinated action that leads to health, income, and social policies that foster greater equity. joint action contributes to ensuring safer and healthier goods and services, healthier public services, and cleaner, more enjoyable environments. health promotion policies require the identification of obstacles to the adoption of healthy public policies in non-health sectors, and ways of removing them. built on progress made from the declaration on primary health care at alma-ata, the aim was to make the healthier choice the easier choice for policy makers as well. the logo of the ottawa charter has been maintained by the who as the symbol and logo of health promotion. health promotion represents activities to enhance and embed the concept of building healthy public policy through: l building healthy public policy in all sectors and levels of government and society l enhancing both self help and social support l developing personal skills through information and education for health l enabling, mediating, and advocating healthy public policy in all spheres l creating supportive environments of mutual help and conservation of the natural environment l reorienting health services beyond providing clinical curative services with linkage to broader social, political, economic, and physical environmental components. (adapted from ottawa charter; health and welfare canada and world health organization, ) an effective approach to health promotion was developed in australia where, in the state of victoria, revenue from a cigarette tax has been set aside for health promotion purposes. this has the effect of discouraging smoking, and at the same time finances health promotion activities and provides a focus for health advocacy in terms of promoting cessation of cigarette advertising at sports events or on television. it also allows for assistance to community groups and local authorities to develop health promotion activities at the workplace, in schools, and at places of recreation. health activity in the workplace involves reduction of work hazards as well as promotion of a healthy diet and physical fitness, and avoidance of risk factors such as smoking and alcohol abuse. in the australian model, health promotion is not only the persuasion of people to change their life habits; it also involves legislation and enforcement towards environmental changes that promote health. for example, this involves mandatory filtration, chlorination, and fluoridation for community water supplies, vitamin and mineral enrichment of basic foods. primary care alliances of service providers are organized including hospitals, community health services serving a sub-district population for more efficient and comprehensive care. these are at the level of national or state policy, and are vital to a health promotion program and local community action. community-based programs to reduce chronic disease using the concept of community-wide health promotion have developed in a wide variety of settings. such a program to reduce risk factors for cardiovascular disease was pioneered in the north karelia project in finland. this project was initiated as a result of pressures from the affected population of the province, which was aware of the high incidence of mortality from heart disease. finland had the highest rates of chd in the world and in the rural area of north karelia the rate was even higher than the national average. the project was a regional effort involving all levels of society, including official and voluntary organizations, to try to reduce risk factors for chd. after years of follow-up, there was a substantial decline in mortality with a similar decline in a neighboring province taken for comparison, although the decline began earlier in north karelia. in many areas where health promotion has been attempted as a strategy, community-wide activity has developed with participation of ngos or any valid community group as initiators or participants. healthy heart programs have developed widely with health fairs, sponsored by charitable or fraternal societies, schools, or church groups, to provide a focus for leadership in program development. a wider approach to addressing health problems in the community has developed into an international movement of "healthy cities". following deliberations of the health of towns commission chaired by edwin chadwick, the health of towns association was founded in by southwood smith, a prominent reform leader of the sanitary movement, to advocate change to reduce the terrible living conditions of much of the population of cities in the uk. the association established branches in many cities and promoted sanitary legislation and public awareness of the "sanitary idea" that overcrowding, inadequate sanitation, and absence of safe water and food created the conditions under which epidemic disease could thrive. in the s, iona kickbush, trevor hancock, and others promoted renewal of the idea that local authorities have a responsibility to build health issues into their planning and development processes. this "healthy cities" approach promotes urban community action on a broad front of health promotion issues (table . ). activities include environmental projects (such as recycling of waste products), improved recreational facilities for young people to reduce violence and drug abuse, health fairs to promote health awareness, and screening programs for hypertension, breast cancer, and other diseases. it combines health promotion with consumerism and returns to the tradition of local public health action and advocacy. the municipality, in conjunction with many ngos, develops a consultative process and program development approach to improving the physical and social life of the urban environment and the health of the population. in , the healthy cities movement involved countries with cities in europe, canada, the usa, the uk, south america, israel, and australia, an increase from cities in . the model now extends to small municipalities, often with populations of fewer than , . networks of healthy cities are the backbone of the movement, with more than member towns and cities across europe. the choice of core themes offers the opportunity to work on priority urban health issues that are relevant to all european cities. topics that are of particular concern to individual cities and/or are challenging and cutting edge for innovative public health action are especially emphasized. healthy cities encourages and supports experimentation with new ideas by developing concepts and implementing them in diverse organizational contexts. a healthy city is a city for all its citizens: inclusive, supportive, sensitive and responsive to their diverse needs and expectations. a healthy city provides conditions and opportunities that encourage, enable and support healthy lifestyles for people of all social groups and ages. a healthy city offers a physical and built environment that encourages, enables and supports health, recreation and well-being, safety, social interaction, accessibility and mobility, a sense of pride and cultural identity and is responsive to the needs of all its citizens. the apha's formulation of the public health role in , entitled the future of public health in america, was presented at the annual meeting in . the apha periodically revises standards and guidelines for organized public health services provided by federal, state, and local governments ( table . ). these reflect the profession of public health as envisioned in the usa where access to medical care is limited for large numbers of the population because of a lack of universal health insurance. public health in the usa has been very innovative in determining risk groups in need of special care and finding direct and indirect methods of meeting those needs. european countries such as finland have called for setting public health into all public policy, which reflects the vital role that local and county governments can play in developing health-oriented policies. these include policies in housing, recreation, regulation of industrial pollution, road safety, promotion of smoke-free environments, bicycle paths, health impact assessment, and many other applications of health principles in public policy. public health involves both direct and indirect approaches. direct measures in public health include immunization of children, modern birth control, and chronic disease case finding -hypertension, diabetes, and cancer. indirect methods used in public health protect the individual by community-wide means, such as raising standards of environmental safety, ensuring a safe water supply, sewage disposal, and improved nutrition (box . ). in public health practice, the direct and indirect pproaches are both relevant. to reduce morbidity and mortality from diarrheal diseases requires an adequate supply of safe water and waste disposal, and also education of the individual in hygiene and the mother in use of ort, and rotavirus vaccination of all children. the targets of public health action therefore include the individual, family, community, region, or nation, as well as a functioning and health system adopting current best practices for health care and health protection. the targets for protection in infectious disease control are both the individual and the total group at risk. for vaccine-preventable diseases, immunization protects the individual but also has an indirect effect by reducing the risk even for non-immunized persons. in control of some diseases, individual case finding and management reduce risk of the disease in others and the community. for example, tb requires case finding and adequate care among high-risk groups as a key to community control. in malaria control, case finding and treatment are essential together with environmental action to reduce the vector population, to prevent transmission of the organism by the mosquito to a new host. control of ncds, where there is no vaccine for mass application, depends on the knowledge, attitudes, beliefs, and practices of individuals at risk. in this case, the social context is of importance, as is the quality of care to which the individual has access. control and prevention of noninfectious diseases involve strategies using individual and population-based methods. individual or clinical measures include professional advice on how best to reduce the risk of the disease by early diagnosis and implementation of appropriate therapy. population-based measures involve indirect measures with government action banning cigarette advertising, or direct taxation on cigarettes. mandating food quality standards, such as limiting the fat content of meat, and requiring food labeling laws are part of the control of cardiovascular diseases. the way individuals act is central to the objective of reducing disease, because many non-infectious diseases are dependent on behavioral risk factors of the individual's choosing. changing the behavior of the individual means addressing the way a person sees his or her own needs. this can be influenced by the provision of information, but how someone sees his or her own needs is more complex than that. an individual may define needs differently from the society or the health system. reducing smoking among women may be difficult to achieve if smoking is thought to reduce appetite and food intake, given the social message that "slim is beautiful". reducing smoking among young people is similarly difficult if smoking is seen as fashionable and diseases such as lung cancer seem very remote. recognizing how individuals define needs helps the health system to design programs that influence behavior that is associated with disease. public health has become linked to wider issues as health care systems are reformed to take on both individual and population-based approaches. public health and mainstream medicine have found increasingly common ground in addressing the issues of chronic disease, growing attention to health promotion, and economics-driven health care reform. at the same time, the social ecology approaches have shown success in slowing major causes of disease, including heart disease and aids, and the biomedical sciences have provided major new technology for preventing major health problems, including cancer, heart disease, genetic disorders, and infectious diseases. technological innovations unheard of just a few years ago are now commonplace, in some cases driving up costs of care and in others replacing older and less effective care. at the same time, resistance of important pathogenic microorganisms to antibiotics and pesticides is producing new challenges from diseases once thought to be under control, and newly emerging infectious diseases challenge the entire health community. new generations of antibiotics, antidepressants, antihypertensive medications, and other treatment methods are changing the way many conditions are treated. research and development in the biomedical to improve the quality of public health practice and performance of public health systems sciences are providing means of prevention and treatment that profoundly affect disease patterns where they are effectively applied. the technological and organizational revolutions in health care are accompanied by many ethical, economic, and legal dilemmas. the choices in health care include heart transplantation, an expensive life-saving procedure, which may compete with provision of funds and labor resources for immunizations for poor children or for health promotion to reduce smoking and other risk factors for chronic disease. new means of detecting and treating acute conditions such as myocardial infarction and peptic ulcers are reducing hospital stays, and improving long-term survival and quality of life. imaging technology has been an important development in medicine since the advent of x-rays in the early twentieth century. technology has forged ahead with high-technology instruments and procedures, new medication, genetic engineering, and important low-technology gains such as impregnated bed nets, simplified tests for hiv and tb, and many other "game changers". new technologies that can enable lower cost diagnostic devices, electronic transmission, and distant reading of transmitted imaging all open up possibilities for advanced diagnostic capacities in rural and less developed countries and communities. molecular biology has provided methods of identifying and tracking movement of viruses such as polio and measles from place to place, greatly expanding the potential for appropriate intervention. the choices in resource allocation can be difficult. in part, these add political commitment to improve health, competent professionally trained public health personnel, the public's level of health information, and legal protection, whether through individuals, advocacy, or regulatory approaches for patients' rights. these are factors in a widening methodology of public health. the centers for disease control and prevention (morbidity and mortality weekly report) in summarized great achievements of public health in the usa, with an extension of the lifespan by over years and improvements in many measures of quality of life. they were updated in a similar summary report in , showing continuous progress, and a global version which was also encouraging in its scope of progress (table . ). these achievements were also seen in all developed countries over the past century and are beginning to be seen in developing countries as well. they reflect a successful application of a broad approach to prevention and health promotion along with improved medical care and growing access to its benefits. in the past several decades alone, major new innovations are leading to greater control of cardiovascular disease, cancer prevention, and many other improvements to health affecting hundreds of millions of people. a similar report by the cdc shows global progress in the first decade of the twenty-first century, while mdg reports show progress on all eight target topics, although not at uniformly satisfactory rates. these achievements are discussed throughout this text. this successful track record is very much at the center of a new public health involving a wide range of programs and activities, shown to be feasible and benefiting from continuing advances in science and understanding of social and management issues affecting health care systems worldwide. public health issues have received new recognition in recent years because of a number of factors, including a growing understanding among the populace at different levels in different countries that health behavior is a factor in health status and that public health is vital for protection against natural or human-made disasters. the challenges are also increasingly understood: preparation for bioterrorism, avian influenza, rising rates of diabetes and obesity, high mortality rates from cancer, and a wish for prevention to be effective. health systems offer general population benefits that go beyond preventing and treating illness. appropriately designed and managed, they: l provide a vehicle to improve people's lives, protecting them from the vulnerability of sickness, generating a sense of life security, and building common purpose within society l ensure that all population groups are included in the processes and benefits of socioeconomic development l generate the political support needed to sustain them over time. health systems promote health equity when their design and management specifically consider the circumstances and needs of socially disadvantaged and marginalized populations, including women, the poor, and groups who experience stigma and discrimination, enabling social action by these groups and the civil society organizations supporting them. health systems can, when appropriately designed and managed, contribute to achieving the millennium development goals. the mdgs selected by the un in have eight global targets for the year , including four directly related to public health (discussed above, box . ). these are a recognition and a challenge to the international community and public health as a profession and as organized systems. formal education in newly developing schools of public health is increasing in europe, including many countries of eastern europe, and beginning to develop in india and sub-saharan africa. but there is delay in establishing centers of postgraduate education and research in many developing countries which are concentrating their educational resources on training physicians. many physicians from developing nations are moving to the developed countries, which have become dependent on these countries for a significant part of their supply of medical doctors. progress in implementation of the mdgs is mixed in sub-saharan africa, making some progress in immunization, but falling back on other goals. proposals to renew global health targets following the end-stage of the mdg health goals will need to add a focus on ncds, which account for percent of global deaths, including . million premature deaths below the age of (undp). economic growth has been hampered by the global recession since , which will affect continued progress with many other factors of changing population dynamics, the economics of prevention versus expensive treatment costs, and the high costs of health care. environmental degradation with high levels of carbon dioxide contamination is a growing concern, with disastrous global warming and consequent effects of drought, flooding, hurricane, and elevated particulate matter-induced asthma and effects on cardiovascular disease. the potential for the development of basic and medical sciences in genetics, nanotechnology, and molecular biology shows enormous promise for health benefits as yet unimagined. at the same time, the effectiveness of health promotion has shown dramatic successes in reducing the toll of aids, reducing smoking, and increasing consciousness of nutrition and physical fitness in the population, and of the tragic effects of poverty and poor education on health status. the ethics of public health issues are complex and changing with awareness that failure to act on strong evidence-based policies is itself ethically problematic. the future of public health is not as a solo professional sector; it is at the heart of health systems, without which societies are open to chronic and infectious diseases that are preventable, affecting the society as a whole in economic and development matters. there is an expanding role of private donors in global health efforts, such as the rotary club and the polio eradication program, gavi with immunization and bed-nets in sub-saharan africa, and bilateral donor countries' help in reducing the toll of aids in sub-saharan africa. the new public health has emerged as a concept to meet a whole new set of conditions, associated with increasing longevity and aging of the population, with the post-world war ii baby-boom generation reaching the over- age group facing the growing importance of chronic diseases. inequalities in health exist in and between affluent and developing societies, as well as within countries, even those having advanced health care systems. regional inequalities are seen across the european region in an east-west gradient and globally a north-south divide of extremes of inequality. the global environmental and ecological degradation and pollution of air and water present grave challenges for developed and developing countries worldwide. yet optimism can be derived from proven track records of success in public health measures that have already been implemented. many of the underlying factors are amenable to prevention through social, environmental, or behavioral change and effective use of medical care. the new public health idea has evolved since alma-ata, which articulated the concept of health for all, followed by a trend in the late s to health in all policies and establishing health targets as a basis for health planning. during the late s and early s, the debate on the future of public health in the americas intensified as health professionals looked for new models and approaches to public health research, training, and practice. this debate helped to redefine traditional approaches of social, community, and preventive medicine. the search for the "new" in public health continued with a return to the health for all concept of alma-ata (renewed in ) and a growing realization that the health of both the individual and the society involves the management of personal care services and community prevention, with a comprehensive approach taking advantage of advancing technology and experience of best practices globally. the new public health is an extension of the traditional public health. it describes organized efforts of society to develop healthy public policies: to promote health, to prevent disease, and to foster social equity within a framework of sustainable development. a new, revitalized public health must continue to fulfill the traditional functions of sanitation, protection, and related regulatory activities, but in addition to its expanded functions. it is a widened philosophy and practical application of many different methods of addressing health, and preventing disease and avoidable death. it necessarily addresses inequities so that programs need to meet special needs of different groups in the population according to best standards, limited resources, and population needs. it is proactive and advocates interventions within legal and ethical limits to promote health as a value in and of itself and as an economic gain for society as well for its individual members. the new public health is a comprehensive approach to protecting and promoting the health status of the individual and the society, based on a balance of sanitary, environmental, health promotion, personal, and community-oriented preventive services, coordinated with a wide range of curative, rehabilitative, and long-term care services. it evolves with new science, technology, and knowledge of human and systems behavior to maximize health gains for the individual and the population. the new public health requires an organized context of national, regional, and local governmental and non-governmental programs with the object of creating healthful social, nutritional, and physical environmental conditions. the content, quality, organization, and management of component services and programs are all vital to its successful implementation. whether managed in a diffused or centralized structure, the new public health requires a systems approach acting towards achievement of defined objectives and specified targets. the new public health works through many channels to promote better health. these include all levels of government and parallel ministries; groups promoting advocacy, academic, professional, and consumer interests; private and public enterprises; insurance, pharmaceutical, and medical products industries; the farming and food industries; media, entertainment, and sports industries; legislative and law enforcement agencies; and others. the new public health is based on responsibility and accountability for defined populations in which financial systems promote achievement of these targets through effective and efficient management, and cost-effective use of financial, human, and other resources. it requires continuous monitoring of epidemiological, economic, and social aspects of health status as an integral part of the process of management, evaluation, and planning for improved health. the new public health provides a framework for industrialized and developing countries, as well as countries in political-economic transition such as those of the former soviet system. they are at different stages of economic, epidemiological, and sociopolitical development, each attempting to ensure adequate health for its population with limited resources. the challenges are many, and affect all countries with differing balances, but there is a common need to seek better survival and quality of life for their citizens (table . ). the object of public health, like that of clinical medicine, is better health for the individual and for society. public health works to achieve this through indirect methods, such as by improving the environment, or through direct means such as preventive care for mothers and infants or other atrisk groups. clinical care focuses directly on the individual patient, mostly at the time of illness. but the health of the individual depends on the health promotion and social programs of the society, just as the well-being of a society depends on the health of its citizens. the new public health consists of a wide range of programs and activities that link individual and societal health. the "old" public health was concerned largely with the consequences of unhealthy settlements and with safety of food, air, and water. it also targeted the infectious, toxic, and traumatic causes of death, which predominated among young people and were associated with poverty. a summary of the great achievements of public health in the twentieth and in the early twenty-first century in the industrialized world is included in chapter and throughout this text. these achievements are reflective of public health gains throughout the industrialized world and are encourage and leverage national, state, and local partnerships to build a stronger foundation for public health preparedness and investigate health problems and health hazards in the community . inform, educate, and empower people about health issues . mobilize community partnerships to identify and solve health problems . develop policies and plans that support individual and community health efforts . enforce laws and regulations that protect health and ensure safety evaluate effectiveness, accessibility, and quality of personal and population-based health services vision, mission and goals guidelines on food fortification with micronutrients. who, geneva. alliance for health policy and systems research essential public health services healthy communities, . model standards for community attainment of the year national health objectives determinants of adult mortality in russia: estimates from sibling data commission on social determinants and health. closing the gap in a generation: health equity through action on the social determinants of health compression of morbidity in the elderly institute of medicine. who will keep the public healthy? educating public health professionals for the st century global alliance for vaccine and immunization (gavi) chronic disease prevention and the new public health the evolution, impact and significance of healthy cities/healthy communities world health organization. ottawa charter for health promotion: an international conference on health promotion behavioral and social sciences and public health at cdc. mmwr health in all policies: seizing opportunities, implementing policies. ministry of social affairs and health new perspectives on the health of canadians: a working document new perspective on the health of canadians: years later the us healthy people initiative: its genesis and its sustainability mortality from cardiovascular and cerebrovascular diseases in europe and other areas of the world: an update strategic review of health inequalities in england post. department of health primary care (extended version): ten key actions could globally ensure a basic human right at almost unnoticeable cost public health in europe: power, politics, and where next health: a vital investment for economic development in eastern europe and central asia. european observatory on health systems and policies. who, european regional office it is not just the broad street pump addressing the epidemiologic transition in the former soviet union: strategies for health systems and public health reform in russia what is the "new public health"? millenium development goals: progress chart united nations development programme, millennium development goals. eight goals for healthy people healthy people. the surgeon general's report on health promotion and disease prevention the millennium development goals: a cross-sectoral analysis and principles for goal-setting after selective primary health care: an interim strategy for disease control in developing countries declaration of alma-ata. international conference on primary health care healthy cities networks across the who, european region preamble to the constitution of the world health organization as adopted by the international health conference regional office for europe. health -health for all in the st century. who regional office for europe, copenhagen. world health organization, . regional office for europe. who european healthy cities network. available at:. who regional office for europe leading health indicators selected for incorporate the original objectives in healthy people , which served as a basis for planning public health activities for many state and community health initiatives. for each of the leading health indicators, specific objectives and subobjectives derived from healthy people are used to monitor progress. the specific objectives set for healthy people are listed in box . . thirteen new topic areas are listed for , such as older adults, genomics, dementias, and social determinants of health. these provide guidelines for national, state, and local public health agencies as well as insurance providers, primary care services, and health promotion advocates. a key issue will be in reducing regional, ethnic, and socioeconomic health disparities.the process of working towards health targets in the usa has moved down from the federal level of government to the state and local levels. professional organizations, ngos, as well as community and fraternal organizations are also involved. the states are encouraged to prepare their own targets and implementation plans as a condition for federal grants, and many states require county health departments to prepare local profiles and targets.diffusion of this approach encourages state and local initiatives to meet measurable program targets. it also sets a different agenda for local prestige in competitive terms, with less emphasis on the size of the local hospital or other agencies than on having the lowest infant mortality or the least infectious disease among neighboring local authorities. the who european region document "health -health for all in the st century" addresses health in the twentyfirst century, with principles and objectives for improving the health of europeans, within and between countries of europe. the health targets include: . closing the health gap between countries. . closing the health gap within countries. . a healthy start in life (supportive family policies). . health of young people (policies to reduce child abuse, accidents, drug use, and unwanted pregnancies). . healthy aging (policies to improve health, self-esteem, and independence before dependence emerges). . improving mental health. . reducing communicable diseases. . reducing non-communicable diseases. . reducing injury from violence and accidents. . a healthy and safe physical environment. . healthier living (fiscal, agricultural, and retail policies that increase the availability of and access to and consumption of vegetables and fruits). . reducing harm from alcohol, drugs, and tobacco. . a settings approach to health action (homes should be designed and built in a manner conducive to sustainable health and the environment). . multisectoral responsibility for health. . an integrated health sector and much stronger emphasis on primary care. . managing for quality of care using the european health for all indicators to focus on outcomes and compare the effectiveness of different inputs. the uk national health service (nhs) has semi-autonomous units in england, scotland, wales, and northern ireland. they are funded from the central uk nhs but with autonomy within national guidelines. the nhs has defined national health outcomes for improvements grouped around five domains, each comprised of key indicators aimed at improving health with reducing inequalities. l preventing people from dying prematurely from causes amenable to health care for all ages: l the target diseases include cardiovascular, respiratory, and liver diseases, and cancer (with focus on cancer of breast, lung, and colorectal cancer) l reducing premature death in people with serious mental illnesses l reducing infant mortality, neonatal mortality, still births, and deaths in young children l increasing -year survival for children with cancer. health improvement; help people to live healthy lifestyles, healthy choices, reduce health inequalities, protection from major incidents and other threats, while reducing health inequalities. l health care, public health and preventing premature mortality; reduce the numbers of people living with preventable ill-health and people dying prematurely, while reducing the gap between communities.source: uk department of health. available at: https://www.gov.uk/government/organisations/department-of-health/about#our-priorities, https:// www.gov.uk/government/uploads/system/uploads/attachment_data/ file/ /improving-outcomes-and -supporting-transparency-part- a.pdf. pdf, and https://www.gov.uk/government/uploads/system/uploads/attach-ment_data/file/ / -nhs-outcomes-framework- - .pdf. pdf [accessed june ] . national policy in health ultimately relates to health of the individual. the various concepts outlined in the health field concept, community-oriented primary health care, health targets, and effective management of health systems, can only be effective if the individual and his or her community are knowledgeable participants in seeking solutions. involving the individual in his or her own health status requires raising levels of awareness, knowledge, and action. the methods used to achieve these goals include health counseling, health education, and health promotion (figure . ).health counseling has always been a part of health care between the doctor or nurse and the patient. it raises levels of awareness of health issues of the individual patient. health education has long been part of public health, dealing with promoting consciousness of health issues in selected target population groups. health promotion incorporates the work of health education but takes health issues to the policy level of government and involves all levels of government and ngos in a more comprehensive approach to a healthier environment and personal lifestyles.health counseling, health education, and health promotion are among the most cost-effective interventions for improving the health of the public. while costs of health care are rising rapidly, demands to control cost increases should lead to greater emphasis on prevention, and adoption of health education and promotion as an integral part of modern life. this should be carried out in schools, the workplace, the community, commercial locations (e.g., shopping centers), and recreation centers, and in the political agenda.psychologist abraham maslow described a hierarchy of needs of human beings. every human has basic requirements including physiological needs of safety, water, food, warmth, and shelter. higher levels of needs include recognition, community, and self-fulfillment. these insights supported observations of efficiency studies such as those of elton mayo in the famous hawthorne effect in the s, showing that workers increased productivity when acknowledged by management in the objectives of the organization (see chapter ). in health terms, these translate into factors that motivate people to positive health activities when all barriers to health care are reduced.modern public health faces the problem of motivating people to change behavior; sometimes this requires legislation, enforcement, and penalties for failure to comply, such as in mandating car seat-belt use. in other circumstances it requires sustained performance by the individual, such as the use of condoms to reduce the risk of sti and/or hiv transmission. over time, this has been developed into a concept known as knowledge, attitudes, beliefs, and practices (kabp), a measurable complex that cumulatively affects health behavior (see chapter ). there is often a divergence between knowledge and practice; for example, the knowledge of the importance of safe driving, yet not putting this into practice. this concept is sometimes referred to as the "kabp gap". the health belief model has been a basis for health education programs, whereby a person's readiness to take action for health stems from a perceived threat of disease, a recognition of susceptibility to disease and its potential severity, and the value of health. action by an individual may be triggered by concern and by knowledge. barriers to appropriate action may be psychological, financial, or physical, including fear, time loss, and inconvenience. spurring action to avoid risk to health is one of the fundamental goals in modern health care. the health belief model is important in defining any health intervention in that it addresses the emotional, intellectual, and other barriers to taking steps to prevent or treat disease.health awareness at the community and individual levels depends on basic education levels. mothers in developing countries with primary or secondary school education are more successful in infant and child care than less educated women. agricultural and health extension services reaching out to poor and uneducated farm families in north america in the s were able to raise consciousness of safe self-health practices and good nutrition, and when this was supplemented by basic health education in schools, generational differences could be seen in levels of awareness of the importance of balanced nutrition. secondary prevention with diabetics and patients with chd hinges on education and awareness of nutritional and physical activity patterns needed to prevent or delay a subsequent myocardial infarction. the who sponsored the first international conference on health promotion held in ottawa, canada, in ( figure . ) . the resulting ottawa charter defined health promotion and set out five key areas of action: building healthy public policy, creating supportive environments, strengthening community action, developing personal skills, and reorienting health services. the ottawa charter called on all countries to put health on the agenda of policy makers in all sectors and at all levels, directing them to be aware a typical healthy city has a population in the multiple thousands, often multilingual, with an average middleclass income. a healthy cities project builds a coalition of municipal and voluntary groups working together in a continuing effort to improve quality of service, facilities, and living environment. the city is divided into neighborhoods, engaged in a wide range of activities fostered by the project. municipalities have traditionally had a leading role in sanitation, safe water supply, building and zoning laws and regulation, and many other responsibilities in public health (see chapter ). the healthy cities or communities movement has elevated this to a higher level with policies to promote health in all actions. some examples are listed of municipal, advocacy group, and higher governmental activities for healthier city environments: working with senior levels of government, other departments in the municipalities, religious organizations, private donors, and the ngo sector to innovate and especially to improve conditions in poverty-afflicted areas of cities is a vital role for health-oriented local political leadership. human ecology, a term introduced in the s and revived in the s, attempted to apply theory from plant and animal life to human communities. it evolved as a branch of demography, sociology, and anthropology, addressing the social and cultural contexts of disease, health risks, and human behavior. human ecology addresses the interaction of humans with and adaptation to their social and physical environment.parallel subdisciplines of social, community, and environmental psychology, medical sociology, anthropology, and other social sciences contributed to the development of this academic field with wide applications in health-related issues. this led to the incorporation of qualitative research methods alongside the quantitative research methods traditionally emphasized in public health, providing crucial insights into many public health issues where human behavior is a key risk factor.health education developed as a discipline and function within public health systems in school health, rural nutrition, military medicine, occupational health, and many other aspects of preventive-oriented health care, and is discussed in later chapters of this text. directed at behavior modification through information and raising awareness of consequences of risk behavior, this has become a longstanding and major element of public health practice in recent times, being almost the only effective tool to fight the epidemic of hiv and the rising epidemic of obesity and diabetes.health promotion as an idea evolved, in part, from marc lalonde's health field concepts and from growing realization in the s that access to medical care was necessary but not sufficient to improve the health of a population. the integration of the health behavior model, social ecological approach, environmental enhancement, or social engineering formed the basis of the social ecology approach to defining and addressing health issues (table . ).individual behavior depends on many surrounding factors, while community health also relies on the individual; the two cannot be isolated from one another. the ecological perspective in health promotion works towards changing people's behavior to enhance health. it takes into account factors not related to individual behavior, which are determined by the political, social, and economic environment. it applies broad community, regional, or national approaches that are needed to address severe public health problems, such as controlling hiv infection, tb, malnutrition, stis, cardiovascular disorders, violence and trauma, and cancer. beginning to affect the health situation in countries in transition from the socialist period. countries emerging from developing status are also showing signs of mixed progress in the dual burden of infectious and maternal/child health issues, along with growing exposure to the chronic diseases of developed nations such as cardiovascular diseases, obesity, and diabetes. the new public health synthesizes traditional pub lic health with management of personal services and community action for a holistic approach. evaluation of costeffective public health and medical interventions to reduce the burden of disease also contributes to the need to seek and apply new approaches to health. the new public health will continue to evolve as a framework drawing on new ideas, science, technology, and experiences in public health throughout the world. it must address the growing recognition of social inequality in health, even in developed countries with universal health programs with improved education and social support systems. for a complete bibliography and guidance for student reviews and expected competencies please see companion web site at http://booksite.elsevier.com/ bibliography key: cord- - v f yz authors: sobers-grannum, natasha; springer, karen; ferdinand, elizabeth; john, joy st title: response to the challenges of pandemic h n in a small island state: the barbadian experience date: - - journal: bmc public health doi: . / - - -s -s sha: doc_id: cord_uid: v f yz background: having been overwhelmed by the complexity of the response needed for the severe acute respiratory syndrome (sars) epidemic, public health professionals in the small island state of barbados put various measures in place to improve its response in the event of a pandemic methods: data for this study was collected using barbados’ national influenza surveillance system, which was revitalized in . it is comprised of ten sentinel sites which send weekly notifications of acute respiratory illness (ari) and severe acute respiratory illness (sari) to the office of the national epidemiologist. during the h n pandemic, meetings of the national pandemic planning committee and the technical command committee were convened. the pharmaceutical and non-pharmaceutical interventions (npis) implemented as a result of these meetings form the basis of the results presented in this paper. results: on june , , barbados reported its first case of h n . from june until october , there were laboratory confirmed cases of h n , with one additional case occurring in january . for the outbreak period (june-october ), the surveillance team received reports of , ari cases, compared to cases for the same period in . the total hospitalization rate due to saris for the year was . per , people, as compared to . per , people for . barbados’ pandemic response was characterized by a strong surveillance system combining active and passive surveillance, good risk communication strategy, a strengthened public and private sector partnership, and effective regional and international collaborations. community restriction strategies such as school and workplace closures and cancellation of group events were not utilized as public health measures to delay the spread of the virus. some health care facilities struggled with providing adequate isolation facilities. conclusions: the number of confirmed cases was small but the significant surge in ari and sari cases indicate that the impact of the virus on the island was moderate. as a result of h n , virological surveillance has improved significantly and local, regional and international partnerships have been strengthened. its response in the event of a pandemic. in accordance with the resolution at the th world health assembly (wha) entitled strengthening pandemic infl uenza prepared ness and response [ ] , barbados developed a national infl uenza pandemic preparedness plan (nipps) in august [ ] . in september , a pandemic fl u outbreak training workshop was held and a pandemic manual was subsequently developed. th is manual was later revised by a team of managers of the public community health centres, and a two day seminar was held in april for private and public sector health care professionals to launch this protocol and to educate participants regarding the appropriate response to dangerous infectious diseases. th ese measures were accomplished through technical cooperation with the pan american health organization (paho) and the caribbean epidemiological centre (carec). in , the national infl uenza surveillance system was revitalized beginning with surveillance of cases of acute respiratory illness (ari) at the countries eight community health centres which served as sentinel sites. th ese sentinel sites (polyclinics) are located at strategic points across the island (figure ). th is was expanded in january , to include the island's lone tertiary public hospital where cases of severe acute respiratory illness (sari) are detected routinely through active surveillance. barbados' nipps plan follows international guidelines with recommendations for both pharmaceutical and non-pharmaceutical interventions to be implemented at various stages of a pandemic. in april , when the world health organization (who) announced that the world was experiencing an infl uenza pandemic, barbadian public health offi cials responded to the threat. in this paper, we examine the response of public health professionals in implementing plans regarded as best practice for developed nations and consider the peculiarities of implementation in a small island state. data for this study was collected using barbados' national infl uenza surveillance system which is comprised of ten sentinel sites, responsible for sending weekly notifi cations to the ministry of health of ari and sari. using guidelines provided carec [ ] , a case was reported as an ari if it met the following case defi nition: acute (sudden) febrile illness (> . ºc or . ºf) in a previously healthy person, presenting with cough or sore throat with or without respiratory distress. cases were reported as sari if they presented a sudden onset of fever over ºc, cough or sore throat, shortness of breath or diffi culty breathing, and required hospital admission. during the pre-pandemic period, as part of routine surveillance, nasopharyngeal swabs were taken from all cases of sari detected at the hospital sentinel site and a sample of six swabs from patients meeting the criteria of ari from two of the most centrally located ambulatory sites. in april , after the announcement by the who that the world had entered pandemic phase fi ve, an enhanced testing strategy was introduced and all primary health care facilities, both private and public, were asked to take nasopharyngeal swabs from all persons who presented with fever (> ºc) with respiratory symptoms and a travel history to an aff ected area. when sustained community transmission of h n was established, this testing strategy was returned to the pre-pandemic level. nasopharyngeal samples taken from suspected cases were sent fi rst to the barbados public health laboratory (local) where they underwent preliminary screening using immunofl uorescence testing. using this method, it is possible to detect infl uenza a virus, adenovirus, respiratory syncitial virus, parainfl uenza types , and and infl uenza b. all samples which met the criteria for testing, irrespective of result, were sent to carec. at the peak of the epidemic in the caribbean, barbadian health offi cials began sending some samples to the u.s. centers for disease control and prevention (cdc) in atlanta, georgia in an attempt to reduce the burden being placed on carec. th e cdc and carec collaborated during the outbreak to provide critical guidance and technical capacity to the region. during the pandemic, the ministry of health's public health offi cials convened meetings of the national pandemic planning committee which met at least weekly for the fi rst two months of the declaration of a pandemic and then monthly for the duration of the outbreak in barbados. a smaller technical command committee was also convened to manage the response to the pandemic and met weekly. at the end of the outbreak period in barbados, a formal evaluation was conducted by many of the major stakeholders within the health sector. th e pharmaceutical and non-pharmaceutical interventions (npis) implemented as a result of these meetings form the basis of the results presented in this paper. the evidence surrounding the use of some npis to delay spread of infection in a pandemic has been found to be weak [ , , ] . aledort et al. published a systematic review which examined the literature and also made recommendations based on expert opinion in cases where there were no or very low quality articles available as a study. here we consider the pharma ceutical and non-pharmaceutical interventions carried out by the government of barbados through the ministry of health, and compare these interventions to the recommendations of the article by aledort et al [ ] . queen elizabeth hospital polyclinic district hospital sobers-grannum et al. bmc public health , (suppl ):s http://www.biomedcentral.com/ - / /s /s . th e cases range in age from -days-old to -years-old, with a mean age of -years-old; the greatest proportion of our cases occurred in the - age group and the second highest in the - age group. a little more than half ( . %) of all confi rmed h n viral infections occurred in females. th e most common presenting symptoms were fever - . % ( cases); and cough or sore throat - . % ( cases). only . % ( ) of cases presented with gastrointestinal symptoms. of the confi rmed cases, there were three fatalities, which occurred in persons with underlying chronic conditions, all of whom were morbidly obese. for the outbreak period (june to october ), the surveillance team received reports of , cases, compared to cases for the same period in . th ere were sari cases from june to october , % ( ) of which required ventilation and care in the intensive care unit. during this time there were seven sari deaths. of these, four received nasopharyngeal swabs that were tested for h n and three tested positive. th e total hospitalization rate due to saris for the year was . per , people, compared to . per , people for . th e highest hospitalization rate occurred in children less than one year ( per , ) followed by those to years old ( per , ). during the initial phases of the pandemic while knowledge of the virus' characteristics was limited, all suspected cases in the island were reported to the offi ce of the national epidemiologist and nasopharyngeal swabs taken. all cases suspected of having h n were investigated and close contacts monitored until the results of the swab were obtained. as the outbreak advanced, only laboratory-confi rmed cases and suspected hospitalized cases were reported. immuno fl ourescent testing was done on the swabs in country to test for infl uenza a virus, but this test was incapable of subtyping and thus swabs had to be sent to a regional centre for real-time polymerase chain reaction testing to be done. th is resulted in wait times for results that averaged one week but were occasionally as long as six weeks. rapid testing was not utilized in barbados. th e ministry of health placed great emphasis on hand hygiene and respiratory etiquette in its communication messages to the public. th e who outbreak communication guidelines [ ] were used as the risk communication guide in responding to the emergence of h n in our community. th ese guidelines use trust, early announcements, transparency, listening and planning as key components of risk communication [ ] . several protocols were distributed on hand hygiene to schools, day care centres, workplaces and the general public. an infectious waste protocol was developed to guide health facilities in the disposal of infectious waste. circulated. th e central storage facility has been improved upon during this time but remains challenged by lack of security to prevent theft and insuffi cient human resources for effi cient stock-taking. as part of their eff orts towards pandemic preparedness, the ministry of health in barbados held a seminar in april , at which they disseminated a manual on management of dangerous infectious diseases to middle-and senior-level managers of at least % of health care facilities in the country. th is manual provided detailed instructions to health care leaders on the structure and type of isolation facilities that ought to be available at their facility. during the outbreak, health care facilities attempted to follow these evidence-based guidelines but were challenged in some regards by their existing structures and layout, and restricted by the high costs that would have been necessary to change these facilities. th e island's lone public hospital is the only major health centre with designated isolation facilities but its capacity was signifi cantly overwhelmed during the outbreak. th e community health centres created temporary isolation areas by reorganizing, and in some cases, curtailing routine services. administrators and health care providers remained committed to the principles of patient isolation for dangerous infectious diseases and have stated their intention to revise their protocols so that there are evidence-based and yet feasible and practical for each facility. ministry of health offi cials took the decision early in the pandemic that there was insuffi cient evidence to support quarantining of asymptomatic persons who had been in contact with a probable or confi rmed case or had travelled to an aff ected area internationally. th e protocol adopted for contact tracing varied according to whether persons were regarded as probable or confi rmed cases. a probable case is an individual with an infl uenza test that is positive for infl uenza a, but is unsubtypable by reagents used to detect seasonal infl uenza virus infection, or an individual with a clinically compatible illness or who died of an unexplained acute respiratory illness, and who is considered to be epidemiologically linked to a probable or confi rmed case. a close contact is an individual who has cared for, lived with or had direct contact with respiratory secretions or body fl uids of a probable or confi rmed case of infl uenza a/h n . for probable cases, close contacts were followed at home and work. contact tracing was coordinated by the medical offi cer of health (community-based public health leader) and a team operating within the community. close contacts with symptoms were isolated at home or in hospital depending on the severity of symptoms. contacts were given a short sensitization session and fact sheets on hand hygiene, respiratory etiquette and proper cleaning methods of laundry and other household items. at the peak of the epidemic in barbados, many primary (ages - ) and secondary schools (ages - ) reported absenteeism rates from schools ranged from as low as % to as high as %. based on the latest available evidence, the ministry of health, in collaboration with ministry of education, decided not to close schools in hope of preventing further spread because the benefi t of doing so was not suffi cient enough to justify the social and economic consequences of such an action. th ere was still, however, some disruption within schools. at the start of the pandemic each school that was aff ected through infection by either students or teachers, was visited by public health offi cials to educate and allay fears of mass morbidity and mortality. th is meant that classes were cancelled for approximately - hours in each case as fears were addressed. public health offi cials also visited the workplaces of the fi rst reported cases to conduct similar educational seminars, so some productivity would have been lost during that time. one school, however, reported high ( %) absenteeism among staff , which resulted in education offi cials making the decision to close the school to prevent issues of discipline and security from arising. th e 'crop over festival' is barbados' major cultural extra vaganza for the calendar year and is a signifi cant source of revenue for the island. th e festival is held from july to august each year and is characterized by social gatherings throughout the season, which may range from to , persons. given the available evidence, the decision was taken not to cancel any of the events associated with the festival, but ill persons were asked not to attend the gatherings. patrons were asked to refrain from their usual custom of waving rags and using shared drink containers. th e festival activities were used to educate the populace in the use of appropriate hand hygiene and respiratory etiquette. th is education was done using calypso jingles that represent the signature musical genre of the festival, as well as through distribution of fl yers along the highways as persons engaged in the festivities. th e barbados drug service was able to procure , courses of oseltamivir (tamifl u) as part of pre-pandemic preparedness. a protocol was developed by the ministry of health to manage the distribution of tamifl u in both the private and public sector. th is protocol was fi rst circulated in may , and use was restricted to those with moderate to severe respiratory illness who met the case defi nition of a suspected case, which at that time included fever, cough and/or sore throat and a travel history to an aff ected area. as the disease became more widespread in barbados, the case defi nition for a suspected case of h n was modifi ed to exclude the travel requirement, and tamifl u usage was thus increased. as more information became available about the virus, the protocol was revised; in july those with mild respiratory illness who had certain specifi ed chronic diseases and those with moderate to severe illness were eligible to receive tamifl u. th e drug was widely used throughout the outbreak and no cases of resistance were reported. plans for procurement of h n vaccine were made through the revolving fund of the pan american health organization. a conference of the sub-regional workshop for the planning of pandemic vaccine introduc tion was attended by ministry of health offi cials to develop a plan for the deployment of the vaccine within two to four weeks after its arrival on the island. th e plan, which was based on a paho vaccination guide [ ] , identifi ed health care workers, pregnant women, and persons over six months with underlying diseases as the main target groups for vaccination. th e initial target was , doses based on estimations of prevalence of the diseases in the barbadian population. due to economic constraints and estimates of anticipated vaccine uptake, the actual number of doses acquired by the government was , doses at a cost of approximately usd , . th is cost includes only that of the actual vaccine and excludes the extra supplies and human resources that would be needed to administer the vaccine. th e vaccination campaign began in february . after four weeks, % of the estimated target group had been reached- % of health care workers, % of pregnant women and % of persons who had been targeted with chronic disease. th e vaccine campaign was extended for a further months; , ( %) doses of the vaccine have been utilized. generally, public health leaders in barbados responded quickly and decisively to the threat of pandemic h n . protocols were developed, disseminated and adhered to in the majority of the private and public sector. th e response was characterized by technical cooperation between public and private sector within the country as well as regional (paho and carec) and extra-regional (cdc) alliances. th e risk communication techniques employed served to construct and reaffi rm partnerships and reassure the barbadian public. one local newspaper produced a headline at the start of the outbreak remarking on the public's "calm response to h n " [ ] . most of the non-pharmaceutical interventions employed (table ) closely followed recommendations made by international organizations such as the who and cdc [ , , ] . for example, hand hygiene and respiratory etiquette which received the strongest evidence in the scientifi c literature [ , , , ] formed the foundation of barbados' pandemic response. for interventions with less conclusive scientifi c evidence, social and economic factors weighed heavily in deciding whether or not to include them. th e use of rapid tests in the pre-pandemic and early pandemic phases was recommended aledort et al [ ] . however, the recommen dation was made with the reservation that these tests often have suboptimal sensitivity [ , ] . several other sources advised against the use of these tests [ ] . in barbados, having weighed the benefi ts of rapid diagnosis against the high costs and wide margins of error, the use of rapid tests was decided against. aledort et al. recommended against the use of surgical and n masks for the general public at all pandemic phases with the exception of the advanced stage where it is stated that the evidence was inconclusive [ ] . however, jeff erson et al. have shown that in health care settings, the use of masks could reduce the transmission of infl uenza [ ] . in barbados' response, persons entering health care facilities such as the polyclinics were asked to wear surgical masks. it is diffi cult to determine the true impact of h n as compared to regular seasonal infl uenza in the island since the national surveillance system is still relatively new. in fact, virological surveillance was practically non-existent prior to the announcement of pandemic phase fi ve. th is component of surveillance was present in the protocol but lacked suffi cient physician motivation and thus ministry of health offi cials used the opportunity of the emerging virus to encourage the taking of nasopharyngeal swabs. th e number of confi rmed cases was small, but the signifi cant surge in ari and sari cases noted at the sentinel sites indicate that the impact of the virus on the island was moderate. barbados enjoyed excellent political commitment to the executing of its pandemic plan but was challenged by limited fi nancial resources. as a result of h n , virological surveillance has improved signi fi cantly and local, regional and international partnerships have been forged and in some cases strengthened. pan american health organization: public health in the americas world health organization: strengthening pandemic-infl uenza preparedness and response, including application of the international health regulations edited by ministry of economic aff airs statistics/ human development/united nations development program world health organization: strengthening pandemic infl uenza preparedness and response caribbean epidemiological centre: regional communicable disease surveillance systems for carec member countries -policy guidelines. port of spain non-pharmaceutical public health interventions for pandemic infl uenza: an evaluation of the evidence base non-pharmaceutical interventions for pandemic infl uenza, national and community measures aiello ae ea: findings, gaps, and future direction for research in nonpharmaceutical interventions for pandemic infl uenza world health organization: who outbreak communication guidelines pan american health organization: tag fi nal recommendations on pandemic infl uenza calm response to h n h n flu: infection control interim guidance for the detection of novel infl uenza a virus using rapid infl uenza diagnostic tests world health organization: who recommendations on the use of rapid testing for infl uenza diagnosis guideline for hand hygiene in health-care settings. recommendations of the healthcare infection control practices advisory committee and the hipac/shea/apic/idsa hand hygiene task force mask use, hand hygiene, and seasonal infl uenzalike illness among young adults: a randomized intervention trial centers for disease control and prevention: respiratory hygiene/cough etiquette in healthcare settings eff ect of hand hygiene on infectious disease risk in the community setting: a meta-analysis comparison of the directigen fl u a+b membrane enzyme immunoassay with viral culture for rapid detection of infl uenza a and b viruses in respiratory specimens physical interventions to interrupt or reduce the spread of respiratory viruses: systematic review response to the challenges of pandemic h n in a small island state: the barbadian experience the authors acknowledge the contribution of the following persons to the pandemic response: the barbados drug service, the medical offi cers of health and senior health sisters of all community health centres (polyclinics) in barbados, and senior managers within the ministry of health including the chief public health nurse, chief environmental health offi cer, chief nursing offi cer as well as the health promotion team. we also wish to acknowledge the authors would like to state that they have no competing interests.authors' contributions nsg made substantial contributions to the acquisition of, analysis and interpretation of data and was responsible for drafting the manuscript. ef, ks and jsj contributed to the conception and design of the study. all authors were involved in revising it critically for important intellectual content and have approved the fi nal version of this publication. key: cord- -vb hygtv authors: elder, laurent; clarke, michael title: past, present and future: experiences and lessons from telehealth projects date: - - journal: open med doi: nan sha: doc_id: cord_uid: vb hygtv information communications technology has been a focus of the work of the international development research centre (idrc) since , when this organization was formed in canada with the goal of helping to improve the health of people in developing countries (http://www.idrc.ca). in this article, we focus on the field of telemedicine in developing countries and its role in improving health, using examples from the experience of the idrc. been a focus of the work of the international development research centre (idrc) since , when this organization was formed in canada with the goal of helping to improve the health of people in developing countries (www.idrc.ca). in this article, we focus on the field of telemedicine in developing countries and its role in improving health, using examples from the experience of the idrc. one of the authors of this article (le) was involved in a pioneering project on telemedicine in uganda in . the aim of this project was to enhance access to health services using telemedicine, such that consultations with doctors who worked in larger hospitals in mulago and butabika could be obtained for patients who did not live near a hospital. the project focused on cholera, malaria and hiv/aids. further goals were to disseminate health information and build a continuing medical education program. finally, the project was meant to document lessons on these different activities. these efforts were quite typical of activities that focused on health and on information and communica-tions technology (ict) at the time: overly ambitious, lacking in adequate capacity and planning, but spurred by the drive and determination of project proponents, who went on to use their experiences to become champions of telehealth in their countries. what actually happened? as was typical of early telehealth projects in africa, the project was faced with challenges related to procuring appropriate equipment and setting up infrastructure, as well as difficulties in achieving connectivity. disappointingly, the project never actually made an online consultation between kampala and the rural health centres, and it would be remiss to say that it resulted in any direct beneficial health outcomes for the rural population. nevertheless, the project did offer some valuable lessons for future e-health projects. it was in many respects ahead of its time, and set the stage for more successful e-health projects in uganda, such as the uganda health information network and a subsequent telehealth project in mengo. indeed, with the support of memorial university in st. john's, nl, the project helped train and mentor numerous staff in telehealth activities; it further helped focus the attention of the government on rural health problems and potential solutions; and it developed educational materials that are in use today. the project provided significant insights and learning. first, it helped the organization better understand the challenges of supporting telehealth projects in africa and helped define some of the key questions it would try to answer. key among these was a better understanding of how appropriate local capacities, both technical and institutional, should be built, second was the need to focus on the "e-readiness" of the country, particularly with regard to the availability of equipment, cost of access and an enabling regulatory environment. (e-readiness refers to the state of a country's ict infrastructure and the ability of consumers, businesses and governments to use ict to their benefit.) finally, this experience prompted greater consideration about the key underlying question: is telehealth a viable means of solving health problems in developing countries? in this case, cost-benefit analyses had not been done and health outcomes had not been measured, in large part because these efforts had been lost in the challenges to implement the pilot project. all these lessons helped shape future thinking about supporting i the development of effective health applications. however, it is also of interest to examine some of the lessons from programming in asia on telehealth to demonstrate how lessons coalesced from one region to the other, despite having been implemented through separate programs. the objectives of the impact of remote telemedicine in improving rural health project in india, part of the pan asia networking (pan) project, were to study the impact of remote telemedicine in selected villages in india. the activity specifically aims to conduct, with the help of n-logue, an internet service company in india (www.n-logue.com), a low-cost medical kit called remedi, which the manufacturer describes as a "medical data acquisition unit that captures multiple parameters," i.e., temperature, ecg readings, blood pressure, pulse rate, heart and lung sounds and oxygen saturation (www.neurosynaptic.com/telemedicine.htm). the telemedicine program can work in conjunction with a rural kiosk and transmit medical information remotely to a doctor in an urban centre. once the service was launched, there was a spike in the number of visitors to the kiosk. after the initial interest, however, the number of visitors dropped precipitously to a few regular, repeat visitors. the drop was explained by the following factors: "kiosk operator's ability to administer the kit properly, acceptability by the villagers, identification of the kiosk in a place where medical care is already dispensed, lack of awareness of the service, distance of the doctor from the village, and availability of competing services such as registered indian medical practitioners primary health centres, local doctors, etc." although the project faced challenges with respect to sustainability, it was, contrary to the ugandan experience, able to function as a working telemedicine project. however, despite the activity's stated objective of understanding telemedicine's "impact," no findings were documented with regard to health outcomes. in indonesia, the development of ict-based telemedicine system for primary community health care in indonesia project used existing internet technology to enhance pc-based medical stations and pilot-tested a telemedicine application. the pilot network consists of six medical stations within community health centres and a station for each referral hospital, health office and test laboratory. the pilot found that human resource capacity-building -in particular, training to facilitate the adoption of computer and telemedicine technology -required significantly more time than expected. the project therefore demonstrated the important role that human resource development plays in the sustainable implementation of ict-based telemedicine systems. however, as before, no findings were documented on the actual effect the pilots had on people's health or on health systems. what parameters were to be used for evaluating programs? textbox lists those factors that were felt to be relevant and important according to a report, commissioned by idrc, that unfortunately ranked all projects "low" with respect to demonstrated health benefits. common deficiencies included a lack of planning and health needs assessment, a need for sustainability planning, difficulty in the management of change, and a need for better evaluation, dissemination of findings, and knowledge transfer to influence policy-making. a comparison of respondents from the two countries showed, as expected, that most received information on antiretroviral treatment (art) from traditional media. however, increased access to information technology in south africa resulted in % of respondents receiving information from cellphones (versus % of respondents in tanzania). hence the assumption is that, as access to mobile telephony and the internet rises in africa, so will the number of people accessing health information through these technologies. moreover, according to the survey, illiteracy was the most important barrier to the use of icts in both south africa and tanzania. the results echo previous research that showed that illiteracy and localization issues are among the most important factors challenging the more widespread use of ict solutions. according to the survey on the effectiveness of icts, it was perceived that radio, print and television, as well as face-to-face meetings, were "extremely effective" media. the majority of respondents "didn't know" whether computers, email and the internet could be effective. strangely, almost % saw the internet as "harmful" (the highest percentage in that category). although one can question the methodology of a perception questionnaire as well as the terms used -what do "harmful" or "extremely effective" actually mean? -one cannot deny that conventional communication methods are still perceived as the most widely used modes of information transmission. the authors of the afriafya (african network for health knowledge management and communication) study conclude that the best practices for using icts in the fight against hiv/aids were ( ) use of mobile phones and sms; ( ) icts for up-to-date hiv management information; ( ) icts for mobilization; ( ) combination of different icts; and ( ) telephone counselling. they also pointed out that the use of "modern" icts is still very limited, but that there is huge potential; that because institutions and health workers remain reliant on "conventional" icts there is a need to integrate both "modern" and "conventional" to get the best results; and, perhaps most important, that changing perceptions and behaviours requires careful planning and patience. similarly, acacia's - prospectus (www.idrc .ca/en/ev- - - -do_topic.html) finds that the impact of icts has been constrained by the fact that access to them at the front lines of health care in rural areas has been generally non-existent. however, the rapid expansion of mobile telephony into urban and rural areas in africa is seen as having brought about new opportunities for access and innovation in the use of icts to facilitate the delivery of health care. although most mobile infrastructure in africa is too slow and expensive for connecting computers to the internet, low bandwidth communication applications have emerged that use mobile phones or personal digital assistants (pdas) such as palm pilots to connect via mobile networks. indeed, "while information designed and formatted for the world wide web is generally too bandwidth intensive to be transmitted over mobile networks, the information itself, properly formatted for small devices, takes up very little bandwidth." pdas and smart phones are also seen as more advantageous because of their robustness (no moving parts), their relative affordability, and their ability to be maintained "in areas with little or no electricity infrastructure through the use of solar power rechargers" (www.idrc.ca/en/ev- - - -do_topic.html ). of particular interest, therefore, is the fact that the acacia program, given that mobile telephony and pdas are increasingly pervasive in africa and have the potential to play an important role there, has focused much of its current project support on that theme (www.itu.int/itu-d/ict/statistics/at_glance/af_ictindicators_ .html). examples of mobile-enabled health applications supported by acacia are listed in textbox . according to the pan asia networking prospectus, health is the area where icts are likely to have the most direct positive impact in improving the well-being of asian communities (www.idrc.ca/uploads/user-s/ prospectus_final.pdf). however, the prospectus also affirms that the first generation of largely donor-driven "telemedicine" projects has generally had only a marginal impact on people's health. indeed, many of the technologies previously developed and tested were too expensive to be widely adopted in resource-poor settings. much like acacia, pan sees the advent of more pervasive technologies, such as mobile phones and pdas, as a new generation of health applications that have actually made a demonstrable difference. as mobile telephony use in asia is more widespread than in africa, it is clear that the potential for these types of applications is significant in asia. pan's strategic document also emphasizes that more research is needed to gauge which applications and projects in the area of health have made a difference, to understand why they have or have not been successful and, when warranted, to scale them up. however, the fast pace of innovation in both icts and health research means that there is also a need to develop, implement and evaluate new applications, particularly in the area of demographic surveillance of disease incidence and medical compliance, using new technologies such as mobile phones. according to the prospectus, another area that has recently come to the forefront in asia is the issue of pandemics. first severe acute respiratory syndrome (sars) and now the potential for an avian flu pandemic are perceived as serious threats to the health of asian populations as well as the rest of the world. a key to mitigating the spread of these infectious diseases is to ensure that data on outbreaks are captured and communicated to the relevant experts in real time. icts can play a critical role in helping to prevent or control pandemics, although more research and experimentation need to be done to identify the most appropriate and cost-effective effective means of developing health communications processes in rural and remote areas, where many of these outbreaks start. as a means of meeting most of its prospectus objectives as well as the challenge of developing evidencebased research on e-health, pan has recently been developing its flagship project, panacea (pan asian collaborative evidence-based ehealth adoption and applications). this program will support collaborative research that promotes the evidence-based adoption and application of technologically and socioeconomically appropriate e-health solutions in asia. it includes projects, involving countries (bangladesh, india, indonesia, mongolia, pakistan, philippines, sri lanka and thailand), and is coordinated by the aga kahn university in pakistan with support from the university of calgary, primacare malaysia, the molave foundation and angeles university foundation in the philippines. the health sector in latin america and the caribbean (lac) faces a number of key challenges, such as equitable access to health care services, the reduction of costs, and the necessary increase of disease prevention measures among low-income and vulnerable populations, among others. as with acacia and pan, the lac prospectus affirms that digital technologies and ictbased solutions provide a powerful tool to change the ways in which health services are managed and delivered to the population at large, and to low-income and marginalized communities in particular. icts and the internet, for example, can bring to these communities (at low cost) contacts with larger health centres located in urban areas, opening access to health prevention measures, consultations, updated valuable medical information, coordination in the treatment of patients, adequate and timely distribution of medicines, collection and effective distribution of valuable data on profiles and patterns of threatening epidemics, contagious diseases and other ailments, among others. attention will also be paid to the relationship between environmental degradation and its impact on the health of the lac population (see www.crdi.ca/uploads/user-s/ public_ict d_americas-programdescription.pdf). we believe that telehealth and e-health solutions can have real, short-term benefits at many levels, including a direct benefit to patients. reductions in medical error, the realization of costs savings, real-time monitoring of public health incidents and the provision of validated data and information for health systems decision-and policy-making are just some of these benefits. however, there is an ongoing need to support research that demonstrates these benefits within the framework of a cost-benefit analysis in order to justify the often significant up-front costs associated with the implementation of comprehensive, system-wide telemedicine solutions. this, of course, is particularly significant in the context of developing countries with limited financial resources and telecommunications infrastructure. although these constraints are limiting in many ways, there are significant opportunities to develop innovative approaches to telemedicine that often do not have to contend with legacy systems and bloated bureaucracies in these environments. telemedicine and e-health solutions that are shown to be appropriate, affordable and effective in one region can be adopted in other regions provided they are localized and contextualized. because significant threats to human health -such as infectious pandemics and geophysical disasters -do not respect political boundaries, these global initiatives carry a sense of urgency. it should be noted that the failure rate for ict projects as an industry average is around % (www.itcortex.com/stat_failure_rate.htm). the fundamental issue that seems to pervade the case histories of failed health ict projects -a lack of focus on the patient -must be addressed. by putting the patient at the centre and continually verifying that the link between the targeted intervention and the well-being of patients is clear, the likelihood of success will be sub-stantially improved. we believe that what is now required is the development of a rigorous research methodology that is relevant and applicable to the context of developing nations. such a methodology must be based on an applied research modality in which the fundamentals of the work address real and significant issues of human health as they influence the development process. the needs of people living in developing countries are profound. their pursuit of equity and full participation in global society faces enormous hurdles but, ultimately, is firmly dependent on a healthy society with full access to effective health care. we are committed to finding a way that ict can achieve this. exploring new modalities: experiences with information and communications technology interventions in the asia-pacific region. a review and analysis of the pan-asia ict r&d grants programme project planning for regional health and ict research network pan-asia past, present and future: experiences and lessons from telehealth projects copyright: this article is licenced under the creative commons attibution-sharealike . canada license, which means that anyone is able to freely copy, download, reprint, reuse, distribute, display or perform this work and that the authors retain copyright of their work. any derivative use of this work must be distributed only under a license identical to this one and must be attributed to the authors. any of these conditions can be waived with permission from the copyright holder. these conditions do not negate or supersede fair use laws in any country. for further information see http://creativecommons.org/licenses/by-sa/ . /ca/. key: cord- -rrwy osd authors: neiderud, carl-johan title: how urbanization affects the epidemiology of emerging infectious diseases date: - - journal: infect ecol epidemiol doi: . /iee.v . sha: doc_id: cord_uid: rrwy osd the world is becoming more urban every day, and the process has been ongoing since the industrial revolution in the th century. the united nations now estimates that . billion people live in urban centres. the rapid influx of residents is however not universal and the developed countries are already urban, but the big rise in urban population in the next years is expected to be in asia and africa. urbanization leads to many challenges for global health and the epidemiology of infectious diseases. new megacities can be incubators for new epidemics, and zoonotic diseases can spread in a more rapid manner and become worldwide threats. adequate city planning and surveillance can be powerful tools to improve the global health and decrease the burden of communicable diseases. t he industrial revolution in the th century led to larger cities with greater potential for growth and development both for the individual and the community. living in a city can provide you with several advantages, such as the possibility for higher education, a new job with higher income, the security of better health care, and the safety of social services. in , the united nations estimated that % of the world's population, . billion, lived in urban centres ( ) . economic growth for countries has been linked to urbanization and countries with high per capita income are among the most urbanized, whereas countries with low per capita income are the least urbanized ( ) . the financial and political power is often concentrated in the cities, which leads to unique possibilities for action and quick response if needed. the process of urbanization refers to increased movement and settling of people in urban surroundings ( ) . however, the meaning of the word 'urban' does not have a universal definition. a wide variety of different interpretations can be found in various countries, and often they do not share the same understanding. different versions could be: living in the capital, economic activities in the region, population size, or even density. the lack of a universal definition makes it hard to compare different countries and cities in regard to public health and the burden and impact of infectious diseases ( ) . many of the studies conducted address the differences between urban and rural areas, and do not compare different urban settings. it can thus be difficult to get a global overview and get a better understanding of the burden of infectious diseases in these specific environments. cities from around the world can also be very heterogeneous and the local diseases and health challenges can greatly differ. the challenges for one city can be completely different for another location ( ) . about a century ago, only % of the world's population lived in cities, and in the least developed countries the percentage was only % ( ) . approximately half of the world's population now live in these urban centres. the two inhabited continents, which currently are the least urbanized, are asia and africa, with respectively and % of the population living in cities. these percentages are expected to rise dramatically by the year to and % respectively ( ) . in the last decade, the growth in the urban population has been the highest in asia, adding . million urban migrants per week. africa was the second highest contributor with . million. the total figure of new urban residents per week during the last decade was on average . million. it is in africa and asia where the current rapid growth is taking place. years are that almost all of the population growth will be in urban areas, but the growth in developed countries is expected to remain largely unchanged ( ) . chronic illnesses have been increasing in importance for the developing world. worldwide the leading causes of death in were ischaemic heart disease followed by stroke, lower respiratory infections, chronic obstructive lung disease, and diarrhoeal diseases. however, if you look at the list for low-income countries, infectious diseases still have a profound impact. the top three causes of death in these settings are all infectious diseases: lower respiratory infections, hiv/aids, and diarrhoeal diseases ( ) . many of the lower income countries are expected to have a major growth among the urban population, which leads to considerable challenges for the governments and health care to keep up to pace and develop their social services and health care as these regions grow. the rise of the new modern cities also creates potential risks and challenges in the aspect of emerging infectious diseases. different risk factors in the urban environment can, for example, be poor housing which can lead to proliferation of insect and rodent vector diseases and geohelminthiases. this is connected to inadequate water supplies as well as sanitation and waste management. all contribute to a favourable setting for both different rodents and insects which carry pathogens and soil-transmitted helminth infections. if buildings lack effective fuel and ventilation systems, respiratory tract infections can also be acquired. contaminated water can spread disease, as can poor food storage and preparation, due to microbial toxins and zoonoses ( ) . the density of inhabitants and the close contact between people in urban areas are potential hot spots for rapid spread of merging infectious diseases such as severe acute respiratory syndrome (sars) and the avian flu. criteria for a worldwide pandemic could be met in urban centres, which could develop into a worldwide health crisis ( ) . adequate city planning can be a key factor for better overall health, and such considerations must be in the mind of the governing bodies. today's megacities are very heterogeneous with large slum settlements, which lead to challenges for overall health and health care in the community. within one large urban setting, there can be huge differences in health conditions depending on where you live. in general, the urban health is better, but in some areas, it can actually be worse compared to certain rural environments ( ) . of the estimated billion people living in urban centres, about one-third live in slum areas ( ) . the ever-changing environment of cities has made certain infectious diseases both emerge and re-emerge. pathogens which adapt to urban environments from rural settings can spread in a more rapid manner, and be a greater burden to the health care services ( ) . this review article examines the urban world and how the current rapid urbanization around the world is affecting the epidemiology of emerging infectious diseases. currently the most rapid growth in urban population is taking place in the developing countries, and poses many different challenges compared to traditional highincome countries. this review focuses on these growing regions and their implications and how emerging infectious diseases affect the community. urban population Á a heterogeneous group with different living conditions cities around the world can look very different if you compare the living conditions for the residents. however, it is not only different cities that can have completely diverse standards of infrastructure and social security. the same city can provide very varying conditions for their residents. living in the slums compared to more wealthy neighbourhoods, will expose the inhabitants to different risks. traditionally cities can offer many advantages compared to rural settings, but under certain circumstances they can rather be a health hazard. the rapid migrations of people to cities can lead to overcrowding, which can generate slums or shanty towns. these slums are characterized by poor housing, lack of fresh water, and bad sanitation facilities ( ) . all of these shortages can be a threat to the residents' health and be a possible breeding ground for infectious diseases. the location of slums are often outside of the city centres, in more hazardous locations and the population feels a lack of social and economic opportunities compared with other residents. in sub-saharan africa, % of the urban population in lived in shanty towns ( ) . for example, in , % of the urban population in central african republic lived in these slums ( ) . in kenya's capital nairobi, % of the population lives in slums, and child mortality there is . times greater than other parts of the city ( ). the community and health care services have great challenges to provide the entire population with equal and adequate service. the collected parties need to be aware of the differences in threats with respect to infectious diseases, both at the local and governmental levels. certain infectious diseases have been shown to be more widespread in the slums. an example of this is the diarrhoeal disease cholera. infections have been linked to slums in dar es salaam, tanzania, with high population density and low income ( ) . in several other countries, cholera incidence is the highest in urban regions with high population density ( , ) . differences in prevalence of asymptomatic carriers of antimicrobial drug-resistant diarrhoeagenic escherichia coli have also been found in brazil between slum settlements and more wealthy parts of the community ). the poor infrastructure in the slum can be a barrier for improvement, but at the same time targeted interventions for safer water and better sanitation carl-johan neiderud facilities could potentially have a profound effect of the overall health. overcrowded housing in high-density populations in the slums can be a breeding ground for infectious diseases such as tuberculosis. the rate of tuberculosis has traditionally been higher in urban centres compared to rural ( , ) . studies in slum settlements in dhaka city, bangladesh, indicate a high prevalence of tuberculosis, which was almost twice as high compared to the overall national average and four times higher than the overall urban levels ( ) . however, different patterns can be seen in different countries; for example, in poland the rates of tuberculosis have shown only slightly lower incidence in rural population compared to urban, . per , versus . per , respectively ( ) . tuberculosis in the united states has declined in the twentieth century, and several factors such as improved nutrition status, socioeconomic status, overall public health, and new drug regimens have been thought to play a major role. however, in the mid- s a resurgence occurred which reached its peak in , especially in urban areas among the homeless and incarcerated population ( ) . the knowledge regarding symptoms, transmission, and prevention has been shown to be greater among the urban population in pakistan's punjab province compared to the rural population. health-seeking behaviour was also better among the urban population, in the aspect of when to seek medical advice for early diagnosis and potential treatment ( ) . information about infectious diseases and how they spread in the community can help the individuals to protect themselves, but knowledge about the slums and the infectious diseases panorama is also crucial for local physicians. they need to know how to look for the correct diagnosis, even if their diagnostic tools might be limited. the right hypothesis from the start in these cases is even more important. the rapid urbanization around the world leads to great challenges in city planning. the rapid influx of migrants can lead to overcrowding and local governments might not be able to provide safe housing, drinking water, and adequate sewage facilities, all of which are potential health hazards and must be taken into account for safe city planning. today more than half of the world's population, almost billion people, have access to piped water connected to their homes. since , well over billion people have gained improved drinking water facilities, and almost billion people have access to improved sanitation. however, more than million people still lack access to improved sources of safe drinking water, and in sub-saharan africa half of the population lack such facilities. globally the decline of open defecation between and went from to %. however, billion people in the world still practice open defecation. in this group, % live in rural areas, but the actual amount of residents from urban settings is gradually increasing. between and , the group in urban settings which lacked sanitation actually significantly increased from million to million, which could be explained by population growth ( ). much of the hard work to improve sanitation facilities has benefited large population groups, but the rapid influx of new urban residents shows that there is still much hard work to be done. residents who are subject to overcrowding and who lack access to safe drinking water or proper sanitation can be more susceptible to soil-transmitted helminths ( ) . these infections are among the most important causes of physical and intellectual growth retardation in the world and have a major impact on public health ( ) . good hygiene practices and good sanitary conditions have lowered the prevalent levels of contamination. in the brazilian city of salvador, with a population of . million, an improvement of sewerage coverage from to % of the households led to an estimated overall reduction of diarrhoeal diseases of % ( ) . neglected tropical diseases can cause substantial health problems in developing countries, and some of these diseases have a faecal-oral transmission pathway. examples of such diseases could be schistosomiasis, trachoma, and soiltransmitted helminthiases. improved sanitation could contribute to a significant improvement for the public health. in many countries, however, the focus is on treatment by medication and not improved sanitation. the reason could be that it would be much more expensive to carry out the necessary infrastructural improvements ( ) . safe drinking water and proper sanitary facilities must be taken into account in city planning. factors like this can potentially have a profound positive effect in lowering infectious diseases with a faecalÁoral route. however, the real challenge lies in the uncontrolled growth of slum settlements. poor housing and overcrowding can also contribute to vector proliferation. one example of this is for chagas disease, which is a parasitic infection caused by the protozoan trypanosoma cruzi. an important mode of transmission is vectorial infected bites of triatomine bugs. living in close contact to domestic animals and poor hygienic habits have also been identified as risk factors ( ) . chagas disease affects an estimated million people every year, and is an important health challenge in latin america. in recent decades, progress has been made to reduce the burden of disease, by vector control, screening blood donors, improved housing, and epidemiological surveillance. chagas disease is a growing health problem in non-endemic areas because of population movements ( ) . it is estimated that , individuals in the united states are infected ( ) and the most affected country in europe, spain, is thought to have , Á , cases ( ) . the example of chagas disease shows that physicians who practice in countries where the disease is not present must be aware of the travel history of the patient to connect the potential symptoms to the correct diagnosis. the environment in urban cities has proven to be favourable for the rat population (rattus spp.) and close encounters between rats and humans can lead to transmission of zoonotic infectious diseases. they can carry pathogens such as yersinia pestis, leptospira spp., rickettsia typhi, streptobacillus moniliformis, bartonella spp., seoul hantavirus, and angiostrogylus cantonensis ( ) . new york city has one of the largest populations of rats in the united states. it has been shown that encounters between rats and humans have been linked to proximity to open public spaces and subway lines, the presence of vacant housing units, and low education of the population ( ) . information like this can be useful for health officials when they launch specific control initiatives. the changes in human population with increased urbanization and urban poverty has also altered our perception of some zoonoses linked to the rat population. leptospirosis has traditionally been perceived as a primarily rural disease, but the incidence in urban centres is increasing ( , ) . in chinese cities, the incidence of seoul hantavirus haemorrhagic fever with renal syndrome has been linked to urban growth, growing rat population, and increase ratÁhuman contact ( ) . large megacities all over the world have large rat populations, but the surveillance and local knowledge seem to be inadequate. a better understanding of how to prevent uncontrolled growth in rat population can potentially lead to a decline of these zoonotic diseases. the growing trend of urbanization around the world has shifted some infectious diseases, which have traditionally been perceived as rural, to urban settings. the world health organization (who) has published a list of neglected tropical diseases. several of them have now become a reality in the urban environment, these diseases are something the practicing physicians in these areas have to be aware of ( ) . many of the diseases on the list are present in the developing world, which sometimes lack the opportunity to solve these problems by themselves. these countries need help from the global community. one of the neglected infectious diseases is lymphatic filariasis (lf) with billion people at risk, and . million in urban areas. one of the main reasons is the lack of proper sanitation facilities ( ) . lf still has its major impact in rural settings, but the increasing urbanization in the developing world has made lf an infectious disease that also has to be considered elsewhere. one of the parasite species wuchereria bancrofti has been located in many urban areas and has the potential for transmission in this environment. moreover, one of the vectors for the parasite is the mosquito culex quinquefasciatus, which thrives in these surroundings, especially in overcrowded areas with poor sanitary and draining facilities. however, within one city the transmission can vary substantially depending on the standard of the sanitary conditions. the mosquito vector culex spp. can be found in large parts of central and south america, east africa, and asia ( ) . another vector which has adapted to urban surroundings is the mosquito aedes aegypti, which is a key component for dengue transmission. dengue is on who's list of neglected tropical diseases, and is on the rise worldwide. the number of infections has drastically increased in the tropical regions of the world in the last years. recent studies have estimated million cases each year, and the burden is the highest in india with onethird of all the new infections ( ) . several factors have played a big role in the escalation, such as urbanization, globalization, and lack of mosquito control. aedes aegypti lay their eggs in artificial water containers made by humans, which is a key component in the urban transmission cycle. the adaption of dengue through its vector has made dengue an infectious disease on the clear rise ( ) . thailand is a country with all four serotypes of dengue virus, and the epidemics of dengue haemorrhagic fever have shown a possible correlation to originate from the urban capital of bangkok and then spread geographically in an outward manner to more rural settlements and provinces. a model to understand this mechanism could lead to more effective use of the health systems in the affected areas ( ) . dengue has become a global problem and is no longer restricted to the developing world. despite better knowledge, it seems tough to control the vector, which has adapted to the urban environment and living close to people. an efficient vaccine is not yet commercially available, but could be a powerful factor in the fight against the global dengue epidemic. often several different factors need to be favourable for a vector-borne disease to adapt to the conditions in an urban environment. for example, west nile virus (wnv) infection is an infectious disease which has become a reality in the urban environment. the primary vector is the mosquito culex pipens, which lay their eggs in water resources which are often man-made. however, for a successful transmission cycle wnv also need the american robin (turdus migratorius), which has several broods per season and hatchlings are more susceptible to wnv infection than adult birds ( ) . the county of dallas, texas, experienced an epidemic of wnv infections in . surveillance reports revealed % of the cases in the united states were found in dallas county ( ) . it shows for a vector-borne disease to have a successful transmission cycle several different factors need to be in place to affect the human population. leishmaniasis is a disease caused by the protozoa leishmania, which affects million and threatens million people in different countries. there can be different clinical presentations such as cutaneous and visceral ( ) . leishmaniasis is transmitted by the vector phebotomine sandflies. when rural migrants bring their domesticated animals to urban settings, often slums, they create favourable conditions for an urban transmission ( ) . it has been shown that it is a growing health problem and the ongoing urbanization has contributed to the increase ( ) . if the different vectors can adapt to the urban environment and man-made resources, the potential health implications can be of major concern. control programs and adequate surveillance is of importance, but in rapidly growing cities and slums it can be tough to implement such measures. emerging infectious diseases can also make the jump to stable transmission in the urban surroundings and surveillance of these can potentially prevent major health concerns and high cost for the health care services. who can play a major role in the fight for better control and knowledge. many of the countries in the developing world do not have the proper resources and the problem is not concentrated to one region, but is a global concern. numerous of the neglected tropical diseases play a major role in the developing world, which is currently experiencing a much faster pace of urbanization compared to the developed world. the who's call for help is important and, for example, dengue is now turning into a global crisis. safe and targeted assistance can be a huge factor for overall health; such assistance could be an effective vaccine or safe and easy vector control programs. urban centres can be catalysts for rapid spread of infectious diseases. the basis of large population groups in a restricted area can provide the perfect conditions for different epidemics. international travel has connected the world in the last century, and this mobility creates a potential threat of many emerging diseases. international tourist arrivals have shown an exceptional growth from million in to , million in . according to the latest forecast from the world tourism organization, international tourism arrivals will continue to increase, and in the figure is expected to be . billion ( ) . with the pace of modern travel, highly contagious infectious diseases can be a potential threat in a completely different setting compared to the original outbreak. urban population and the density of residents can meet the criteria for a new epidemic and create a public health disaster, if not taken seriously. international trade and travel can potentially also contribute to the occurrence of a worldwide pandemic. sars emerged as a global threat in . sars is thought to originate from the sars-like coronavirus (scov) of bats and reached the human host in china due to hunting and trading of bats for food ( ) . the disease was first recognized in wildlife markets in guandong, china. investigations have found this scov from the himalayan palm civets in live-animal markets in the region. the first cases of sars reportedly occurred in individuals who handled these animals to prepare exotic food, and the virus is thought to have crossed over to their human host ( ) . sars could then spread throughout the world by, for example, international travel. it spread in urban dwellings in large cities and in wellequipped city hospitals. public fear of travelling led to considerable economic losses that affected entire countries ( ) . the example of sars shows that food markets in southern china can be the origin of a worldwide health crisis. travel routes around the world have connected the urban world and large megacities like never before. accordingly it is important to take necessary preventive measures before the epidemic gets out of control, and here big organizations like who, but also governments, play an important role. early action is of utmost importance, and functional surveillance programs needs to be in place. the zoonotic disease dengue is endemic in most tropical and subtropical regions, which often are also popular tourist destinations. travellers to endemic countries can contribute to the spread of the disease. the burden of disease is on the rise, and estimations are that in returning travellers from southeast asia, dengue is now a more frequent cause of febrile illness compared to malaria ( ) . dengue is now an urban health problem, which is one of the major reasons why the rise is exceptional. the global rising problem of antibiotic resistance has also been linked to international travel. the worldwide spread of certain antibiotic resistant staphylococcus aureus has been linked to tourism, which shows the potential impact on international health ( , ) . faecal colonization with esbl-producing enterobacteriaceae has also been linked to international travellers in several studies ( Á ). the physician needs to take into account the recent travel activities of the patient to better evaluate the current condition and need for potential treatment and care. global travel shows no signs of decline and the interconnected megacities around the world make global surveillance even more important when it comes to contagious infectious diseases. measurements to stop the spread need to be taken at the original location, but knowledge about the specific disease needs to be passed on to the global community and local health workers in other parts of the world. this global surveillance and alert system needs to be fast and efficient to, if possible, reduce the impact. the expected rise of travel makes it critical for the future global health and the possibility to react in time for possible threats. zoonotic disease a challenge for the future rapid and sometimes uncontrolled urbanization can, in certain circumstances, lead to closer encounters with wildlife. human influence on the ecosystems creates meeting points for new and potential zoonotic diseases, which could have a profound impact for both local and global health. the global trends of urbanization push people to previously untouched ecosystems. new housing in the outskirts of big cities can potentially be meeting points for new and already known zoonotic diseases. of emerging infectious diseases, which have been recognized between and , more than % have been zoonotic diseases ( ) . living in close contact to domesticated animals and hunt for 'bush-meat' can also be risk factors for an infectious disease to make the jump from the animal host to humans. major deforestation creates closer contact between humans and bats and even primates, who can potentially be host for 'new' viruses. a better understanding, surveillance, and prevention of zoonotic diseases would be of great value, to both prevent and manage this upcoming threat for global health. hot spots for this transmission have been found and they often correlate where the process of urbanization is on the clear rise ( ) . even if it is not always the urban population who is at the front of new encounters with wildlife, it can still have an effect on urban health. the trend of people moving to cities are at the highest, where many of these new encounters with ecosystems take place, and infectious diseases can be introduced to these growing urban environments. the sometimes uncontrolled growth of cities pushes residents to untouched ecosystems when new housing expands. ebola virus disease (evd) has had a profound impact on the world in . since the spring of , the world has witnessed an unprecedented epidemic of this zoonotic disease. the hub of the epidemic has been the three countries in western africa: sierra leone, liberia, and guinea. it all began in december in guinea, in the providence of guéckédou, in the eastern rainforest region. the disease transmission in the capital of conakry is thought to be the first major urban setting for evd ( ) . who was first notified of the evd outbreak in march , and on august , the who declared the current situation as 'public health emergency of international concern' ( ). before, evd outbreaks in central africa had been limited in size and geographical spread to a few hundred persons, mostly in remote areas and not large urban settings ( ) . the centre of the epidemic (guinea, liberia, and sierra leone) has, as many of their neighbouring countries, a large population living in rural settings; only , , and % of their population live in urban centres ( Á ). the population is, however, highly interconnected in these countries with travel and crossborder traffic, with good road access between rural and urban settings. these communications have made the magnitude of the evd epidemic possible. despite cases of evd in nigeria and lagos, a megacity with million inhabitants, the transmission has been limited, which proves that implementation of control measures can limit the transmission ( ) . the mortality rate has been high in previous outbreaks, up to % ( ) . the fatality rate in the west africa epidemic has been estimated to around % for guinea, liberia, and sierra leone when data for patients with recorded definitive clinical outcomes ( ) . this unprecedented epidemic points out the importance of better surveillance, understanding, and preventions measures for this potentially deadly virus. ebola virus (ebov) is thought to be a zoonotic disease, and fruit bats are under investigation to be the natural reservoir. ebov sequences have been found in these animals near the human outbreaks which implies where the virus might originate from ( , ) . closer contact with humans and fruit bats are thus risks for a new global health crisis and the severity of an ebola epidemic has already been witnessed. the high costs, both from an economic and overall health perspective, have affected entire countries and have even cost lives on the other side of the earth. urban centres offer their residents greater possibility for health and social services. different factors, such as education, direct primary care services, and the governments' capacity for rapid response to upcoming health threats, can contribute to the opportunities in a city. however, in many cities the poor can find it difficult to access proper health care, due to the cost of such services. in more rural areas, the problem can instead be the distance to the nearest clinic, which in reality makes it impossible for prompt and efficient treatment ( ) . malaria has historically been and is still a major health concern in large parts of the world. who estimates million cases ( Á million) of malaria and , deaths ( , Á , ) in . the highest mortality rates have been shown to be closely linked to poor countries with a low gross national income (gni) per capita ( ) . estimations have been made that nearly % of the total african population, million, currently live in urban settings where malaria transmission is a reality. the annual incidence is estimated at . Á . million cases of clinical malaria among the urban population in africa ( ) . the relationship between the malaria mosquito vector and the human host determines the burden of morbidity and mortality. this interface is dependent on many different factors and the degree of urbanization is an important one. a significant reduction in malaria transmission has been observed over the last century. increased urbanization and decreased transmission have correlated in several different studies ( ) . however, whether it was the increased urbanization that led to a reduction in transmission or the malaria reduction that led to development that promoted urbanization of societies is a challenge to determine ( ) . a clear connection has been shown between reduced transmission of plasmodium falciparum and urbanization; however, for plasmodium vivax it is less obvious. for p. vivax, a connection has been found globally and in asia and africa; inconsistent results, however, were found in the americas. several possibilities could explain these incoherent results, such as more widespread transmission of p. vivax, lower transmission intensity, the wide distribution in asia, and high prevalence of duffy negativity in africa, which protects against p. vivax ( ). the overall decrease of the burden of malaria has been a positive effect of urbanization, but the exact mechanisms are not yet known. however, it seems that urbanization can have a favourable influence. immunization status between residents in urban centres and rural areas can differ. coverage of measles vaccination in indonesia have shown to be . % in rural areas, compared with . % in urban regions ( ) . studies in nigeria have shown that sometimes the coverage can actually be better in more rural areas, and it might be explained by better mobilization and participation in the delivery of immunization services ( ) . in a study in uganda, % of the urban group compared to % in the rural areas were fully immunized, but polio vaccine was given to % in the urban group and % in the rural group ( ) . immunization coverage can also vary considerably among different settings, not only between rural and urban surroundings, but also between urban, rural, and slum settlements. in changdigarh, a union territory of india, full immunization of children at the age of was % in slums, % in urban, and . % in rural settings ( ) . it shows that there can be a wide variety of reasons for immunization status among the population in different regions and countries of the world. effective immunization can be a cost-effective measure in poorer countries. high coverage can prevent epidemics in large cities and save many lives; however, immunization needs to be available both for the rural and urban population to achieve the greatest benefit. a study in tanzania has compared the knowledge about certain zoonotic diseases among general practitioners in urban and rural areas. the rural practitioners had poor knowledge of how sleeping sickness is transmitted and clinical features of anthrax and rabies. laboratories in rural areas are often poorly equipped and cannot always diagnose certain zoonotic diseases, which could limit the doctors' capability for correct diagnosis and treatment ( ) . public knowledge about certain infectious diseases can also vary depending on many different factors. the knowledge about sexually transmitted diseases (stis) among bangladeshi adolescents was higher among people in urban areas compared to rural, both in general and hiv and aids ( ) . the same results about hiv and aids have been found among a canadian population ( ) . studies in chengdu and shanghai, china, have shown risk perception about stis and hiv and aids is profoundly changed in rural-to-urban migrants ( , ) . the same result has been shown in a study among rural-to-urban migrants in ethiopia ). the rapid influx of migrants moving to cities makes it hard to get adequate information to all the different groups in the society. to educate the public is one of the many challenges for local governments and health officials. campaigns to improve the public knowledge are useful to fight the threat of infectious diseases. residents need to be aware of symptoms of infectious diseases to gain knowledge about when to seek health care and when it is safe to treat yourself. knowledge about food storage, waste management, vector control, and sanitary facilities are all aspects that can lower the burden of communicable diseases. these campaigns can sometimes be easier in the urban environment because of the density of the population. urbanization is an ongoing process in the world at the moment, but the pace of the process is not universal. the developed countries, which have traditionally been thought of as high-income countries, are already urbanized, and it is in the developing world that the rapid rise is taking place. infectious diseases still have a big impact on the global health, and urbanization is now altering the characteristics of these diseases. living conditions in cities are overall better in urban environments compared to rural settings; better housing, sanitation, ventilation, and social services all play an important role in this improvement. certain pathogens can, however, adapt to the different conditions and thus create a new challenge for both local governments and the global community. the capacity for surveillance, control programs, prevention, and public knowledge programs is far better in cities. it is here where the resources and political and financial power are gathered. but some countries do not have the resources and because these diseases can be of global concern, it is also the international community's responsibility to help and support with knowledge and resources. the rapid urbanization has also interfered in previously untouched ecosystems. these new settlements create new and closer encounters with wildlife, which can be a potential source of zoonotic diseases. these can be both previously known or new pathogens, which make the shift from their animal host to generate infections in humans. surveillance is of primary importance to monitor the burden of disease and will give both local authorities and the global community a chance for a quick response to public health threats. world urbanization prospects: revision highlights hidden cities: unmasking and overcoming health inequities in urban settings urbanization and human health urbanisation and infectious diseases in a globalised world the transition to a predominantly urban world and its underpinnings united nations human settlements programme (un-habitet) the top causes of death our cities, our health, our future Á acting on social determinants for health equity in urban settings facts: urban settings as a social determinant of health informal urban settlements and cholera risk in dar es salaam spatial and demographic patterns of cholera in ashanti region-ghana outbreak of cholera in ibadan, nigeria high prevalence of antimicrobial drug-resistant diarrheagenic escherichia coli in asymptomatic children living in an urban slum from exposure to disease: the role of environmental factors in susceptibility to and development of tuberculosis epidemiology and control of tuberculosis in western european cities epidemiology of tuberculosis in an urban slum of dhaka city tuberculosis in poland in the epidemiology of tuberculosis in the united states urban-rural inequities in knowledge, attitudes and practices regarding tuberculosis in two districts of pakistan's punjab province soil-transmitted helminth infections: updating the global picture soil-transmitted helminth infections: ascariasis, trichuriasis, and hookworm effect of city-wide sanitation programme on reduction in rate of childhood diarrhoea in northeast brazil: assessment by two cohort studies sanitation and health socio-cultural aspects of chagas disease: a systematic review of qualitative research an estimate of the burden of chagas disease in the united states chagas disease in spain, the united states and other non-endemic countries rats, cities, people and pathogens: a systemic review and narrative synthesis of literature regarding the ecology of rat-associated zoonoses in urban centers rat sightings in new york city are associated with neighborhood sociodemographics, housing characteristics, and proximity to open public spaces urban epidemic of severe leptospirosis in brazil. salvador leptospirosis study group leptospira as an emerging pathogen: a review of its biology, pathogenesis and host immune responses investigating the effects of climatic variables and reservoir on the incidence of hemorrhagic fever with renal syndrome in huludao city, china: a -year data analysis based on structure equation model sustaining the drive to overcome the global impact of neglected tropical diseases Á second who report on neglected diseases effect of water resource development and management on lymphatic filariasis, and estimates of population at risk urban lymphatic filariasis the global distribution and burden of dengue urbanization and globalization: the unholy trinity of the (st) century travelling waves in the occurrence of dengue haemorrhagic fever in thailand host-seeking heights, host-seeking activity patterns, and west nile virus infection rates for members of the culex pipiens complex at different habitat types within t he hybrid zone controlling urban epidemics of west nile virus infection the increase risk factors for leishmaniasis worldwide the leishmaniases as emerging and reemerging zoonoses tourism highlights . world tourism organization bats are natural reservoirs of sars-like coronaviruses isolation and characterization of viruses related to the sars coronavirus from animals in southern china. isolation and characterization of viruses related to the sars coronavirus from animals in southern china the world health report Á a safer future: global public health security in the st century dengue infections in travellers major west indies mrsa clones in human beings: do they travel with their hosts? global distribution of panton-valentine leucocidin Á positive methicillin-resistant staphylococcus aureus travel-associated faecal colonization with esbl-producing enterobacteriaceae: incidence and risk factors foreign travel is a major risk factor for colonization with escherichia coli producing ctx-m-type extended-spectrum beta-lactamases: a prospective study with swedish volunteers colonisation with escherichia coli resistant to ''critically important'' antibiotics: a high risk for international travellers global trends in emerging infectious diseases prediction and prevention of the next pandemic zoonosis ebola virus disease outbreak in west africa who statement on the meeting of the international health regulations emergency committee regarding the ebola outbreak in west africa ebola outbreaks who ebola response team. ebola virus disease in west africa Á the first months of the epidemic and forward projections ebola haemorrhagic fever fruit bats as reservoirs of ebola virus recent common ancestry of ebola zaire virus found in a bat reservoir world malaria report urbanization in sub-saharan africa and implication for malaria control urbanization, malaria transmission and disease burden in africa urbanization and the global malaria recession the effects of urbanization on global plasmodium vivax malaria transmission determinants of apparent rural-urban differentials in measles vaccination uptake in indonesia community participation and childhood immunization coverage: a comparative study of rural and urban communities of bayelsa state, south-south nigeria factors influencing childhood immunization in uganda reproductive and child health inequities in chandigarh union territory of india knowledge of causes, clinical features and diagnosis of common zoonoses among medical practitioners in tanzania nyströ m l. urban-rural and socioeconomic variations in the knowledge of stis and aids among bangladeshi adolescents talking about, knowing about hiv/aids in canada: a rural-urban comparison vulnerable but feeling safe: hiv risk among male rural-to-urban migrant workers in chengdu sexual behavior among employed male rural migrants in hiv-related sexual behaviors among migrants and non-migrants in rural ethiopia: role of rural to urban migration in hiv transmission i would like to thank the two anonymous reviewers for their insightful opinions. the author have not received any funding or benefits from industry or elsewhere to conduct this study. key: cord- -a srympy authors: haines, andy; de barros, enrique falceto; berlin, anita; heymann, david l; harris, matthew j title: national uk programme of community health workers for covid- response date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: a srympy nan an observation that could not be readily explained by the authors. benefits of esett are its doubleblind design and the inclusion of valproate. however, the study did not include infants younger than years, which probably reflects concerns of the potential hepatotoxicity of the drug in this age group. esett has a few limitations. the first limitation is the subjective nature of assessing seizure cessation in the absence of electroencephalography, a feature shared by eclipse and consept. this measure reflects real life and also clinical practice and acumen in an emergency situation. another potential limitation is the conjoint nature of the primary outcome, clinically apparent seizure and improving consciousness. such an endpoint might have influenced the primary efficacy outcome, which has been acknowledged by the authors. additionally, unlike in eclipse and consept, a seizure is assumed to be a convulsive seizure, which was not made explicit in their results. the esett team concluded that levetiracetam, fosphenytoin, or valproate could be used as the first choice, secondline treatment, which mirrors the conclusions of eclipse and consept (levetiracetam or phenytoin). the consept team have taken a further leap of faith, and largely into the unknown, suggesting that clinicians should consider the sequential use of levetiracetam and phenytoin (in any order) before progressing to thirdline management of rapid sequence induction with anaesthesia. the inclusion of valproate in a threedrug sequence would inevitably extend the duration of status epilepticus and risk irreversible neurological sequelae. a more rational first step would be a metaanalysis of these and other relevant randomised controlled trials. , such an analysis would subsequently inform a multidisciplinary debate between, and output from, general paediatricians and paediatric specialists in emergency medicine, neurology, anaesthetics, and intensive care. esett has substantially improved the evidence base in the secondline management of paediatric convulsive status epilepticus. the collective results of these three trials now demand careful interpretation and application of the evidence. i declare no competing interests. the roald dahl neurophysiology department, alder hey children's health park, liverpool, l ap, uk the coronavirus disease (covid ) pandemic threatens to kill large numbers of people in the uk and to place unprecedented demands on the national health service (nhs). the case fatality rate is increased in older people and those with preexisting disease and is reported to be about % in people with covid who are older than years, although this does not take into account the underreporting of mildly affected cases. there are about · million people aged years or older in the uk and many others with health conditions that increase their vulnerability to covid . in the face of the rapid spread of severe acute respiratory syndrome coronavirus , older people and other vulnerable groups are being asked to selfisolate for a considerable time to reduce the risks of infection, with potential adverse effects on physical and mental health. we propose a largescale emergency programme to train community health workers (chws) to support people in their homes, initially the most vulnerable but with potential to provide a longterm model of care in the uk. experience from brazil, pakistan, ethiopia, and other nations shows how a coordinated community workforce can provide effective health and social care support at scale. [ ] [ ] [ ] to respond to the covid pandemic, we suggest that chws would be young people, aged - years, in whom the likelihood of serious consequences from covid is currently deemed low. this demographic is increasingly likely to have been exposed to covid and therefore have acquired immunity. largescale unemploy ment as a consequence of the economic impact of this pandemic makes this a group potentially in need of employment opportunities. despite the uk government's enormous package of benefits designed to retain people in employment, substantial job losses are likely. furthermore, up to medical and physician associate students could be involved who cannot participate in usual clinical placements, possibly until september, , because clinical attachments are being suspended. in brazil, chws are trained over - weeks to deliver a wide range of health promotion activities. this model suggests that a - week basic training programme on covid and on public health surveillance could provide core skills and knowledge, particularly when combined with ongoing training and supervision. online courses are available from some academic institutions on covid and emergency measures to accredit and certificate these courses to agreed standards could be implemented. recruitment and training could be overseen by health education england, commissioned from a higher edu cation provider or devolved to an organisation such as public health england. chws could undertake regular review of vulnerable people at home in person or virtually, depending on need, and when patients become ill chws could undertake simple assessment of the need for more advanced care, reporting to other members of the primary care team, including to the covid health management team that is being commissioned. chws would need to be provided with personal protective and other equipment and trained to follow protocols to assess temperature, blood pressure, and, with the provision of portable pulse oximeters, early detection of severe illness, thus collecting data for clinical and epidemiological purposes. similar protocols are already in place and used by chws in diverse settingseg, as part of the integrated management of newborn and childhood illness. additionally, home visits for vulnerable people would allow chws to assess whether individuals have adequate supplies of food and medicines for long term conditions, are aware of basic hygiene precautions, and whether they have mental health problems. in future, chws might be involved in covid community testing and possibly supporting vaccine trials. over time, chws might also contribute to the management of longterm conditions through monitoring physical and mental health, and reviewing availability and use of medicines. entry criteria could include occupations that provide basic training in first aid or assessing medical emergencies, such as flight attendants, or registration on a health professional training programme. although final year medical students might shortly be deployed in acute hospital settings, other senior medical students could be trained to provide supervision of chws. they could be overseen by public health trainees and ultimately by qualified public health professionals in a pyramidal structure, in collaboration with general practitioners and practice pharmacists. virtual chat rooms could be used for working out solutions to common problems and virtual mentorship. the clinical students could work as volunteers in return for accreditation of valuable experiential learning in community health. this approach would meet a gap in uk undergraduate experience and might become a longterm feature of medical education. for a future scaled workforce, there will be financial implications, but the costs should be affordable. on the basis of the brazilian chw model, estimates of the cost of a scaled chw workforce in england suggest this could amount to about £ · billion per annum for chws. such an amount is a small proportion of the existing nhs budget that is projected to increase in the coming years. some would argue that it is too risky to put chws with only limited training in contact with vulnerable members of society. however, there are risks associated with prolonged wellbeing, and economic stability of women, girls, and vulnerable populations. people whose human rights are least protected are likely to experience unique difficulties from covid . women, girls, and marginalised centring sexual and reproductive health and justice in the global covid- response unmonitored isolation, from the effects of covid , as well as loneliness and mental health deterioration. the risks of using chws in this way could be reduced by supervision, with independent monitoring and evaluative research to identify problems early and correct them. the chws could visit in pairs to reduce the risks. people might resist or be reluctant to be visited by chws, and they could opt out of home visits at any time, but experience with chws in brazil in the past years suggests this would happen rarely. in brazil, chws provide a much needed and relied upon service. chws in brazil have been established for many years, are well integrated into their communities, and provide a wide range of health and social care support activities to each of the - households that they are responsible for. therefore, in brazil, additional roles for preventing the spread of and supporting those infected with covid or in selfisolation could be integrated into the work of chws. much can be learned from countries with successful experiences of radical, largescale workforce interventions. it could be argued that this is an unrealistic proposal and that adapting the existing system or training so many people is too challenging. however, current health and social care systems in the uk are under extreme pressure and could become overwhelmed. in a time of fear, isolation, and growing health inequalities, use of chws for the covid response would boost social coherence and fill gaps that have begun to emerge between health and social care and inperson and virtual access to health care. our proposal for chws would produce a large cadre of people with an understanding of basic epidemiological and public health concepts who could challenge scientific misinformation and explain the rationale for specific health policies and interventions to the public. this approach would also help build a new generation of leaders who can help tackle the complex challenges of our age. efdb is chair of the working party on the environment of the world organization of family doctors. mjh is a nonexecutive director of primary care international. mjh is supported in part by the nw london national institute for health research (nihr) applied research collaboration. imperial college london is grateful for support from the nw london nihr applied research collaboration and the imperial nihr biomedical research centre. the views expressed in this comment are those of the authors and not necessarily those of the nihr or the department of health and social care. we declare no other competing interests. incidence, cause, and shortterm outcome of convulsive status epilepticus in childhood: prospective populationbased study drug management for acute tonic clonic convulsions including convulsive status epilepticus in children advanced paediatric life support: a practical approach to emergencies, th edn epilepsies: diagnosis and management. clinical guideline evidencebased guideline: treatment of convulsive status epilepticus in children and adults: report of the guideline committee of the randomized trial of three anticonvulsant medications for status epilepticus efficacy of levetiracetam, fosphenytoin, and valproate for established status epilepticus by age group (esett): a doubleblind, responsiveadaptive, randomised controlled trial levetiracetam versus phenytoin for secondline treatment of paediatric convulsive status epilepticus (eclipse): a multicentre, openlabel, randomised trial levetiracetam versus phenytoin for secondline treatment of convulsive status epilepticus in children (consept): an openlabel, multicentre, randomised controlled trial randomized controlled trial of levetiracetam versus fosphenytoin for convulsive status epilepticus in children iv levetiracetam versus iv phenytoin in childhood seizures: a randomized controlled trial who. report of the whochina joint mission on coronavirus disease (covid ) the potential contribution of community health workers to improving health outcomes in uk primary care one million community health workers: technical taskforce report brazil's family health strategy: delivering community based primary care in a universal system dalglish sl on behalf of the strategic review study team. towards a grand convergence for child survival and health: a strategic review of options for the future building on lessons learnt from imnci. geneva: world health organization public health education in uk medical schools-towards consensus integrating community health workers in primary care: a solution to the workforce crisis budget : what you need to know delivering cost effective healthcare through reverse innovation health equity in england: the marmot review years on. london: institute of health equity epidemiology-a science for the people key: cord- -wqqfpr g authors: yilmaz, ozge; gochicoa‐rangel, laura; blau, hannah; epaud, ralph; lands, larry c.; lombardi, enrico; moore, paul e.; stein, renato t.; wong, gary w. k.; zar, heather j. title: brief report: international perspectives on the pediatric covid‐ experience date: - - journal: pediatr pulmonol doi: . /ppul. sha: doc_id: cord_uid: wqqfpr g the novel coronavirus (sars‐cov‐ ) is endangering human health worldwide; scarcity of published pediatric cases and current literature and the absence of evidence‐based guidelines necessitate international sharing of experience and personal communication. on march the international committee of the american thoracic society pediatrics assembly recorded an online podcast, during which pediatric pulmonologists worldwide shared their experience on the novel coronavirus disease (covid‐ ) in children. the aim was to share personal experience in organizing pediatric care in different health care settings globally, protecting health care workers, and isolation practices. this manuscript summarizes the common themes of the podcast which centered around three main topics: more benign clinical disease and progression in pediatric cases compared to adults, a strong need for strategies to protect health care workers, and social or economic disparities as a barrier to successful pandemic control. the common themes of the podcast centered around three main topics: more benign clinical disease and progression in pediatric cases compared with adults, a strong need for strategies to protect health care workers, and social or economic disparities as a barrier to successful pandemic control. as depicted in recent articles from china and korea, pediatric cases constitute a small percentage of the total covid- hospitalized cases worldwide with low mortality being reported in children. [ ] [ ] [ ] evaluation of the symptomatic and asymptomatic children younger than years of age in wuhan with known contact with covid- cases found that . % of those tested were confirmed to have sars-cov- infection; pneumonia was the most common diagnosis amongst symptomatic children. similarly, the center for disease control and prevention in china reported that only % of hospitalized cases were younger than years of age; in korea under % of cases were under years of age. the chronic respiratory disease did not appear to be emerging as a risk factor for severe covid- disease; however, long term follow-up is needed to confirm this observation. lack of information on long term prognosis of asymptomatic children and those with pneumonia should be a research priority. availability of surgical and n masks is an issue, and these should be reserved for use in health care facilities given the global shortages. homemade cloth masks are appropriate for use by the public. anxiety, stress, and exhaustion among health care workers are also key concerns. a flexible action plan is important component management. action plan on quarantine measures, separating health care workers who have contact, and who do not have contact with patients is important. the flexibility of the action plan to move adequate health care workers to the required areas in the hospital will be required during the pandemic. as the epidemic moves from high-income countries to africa and latin america, key concerns about access to ppe for hcws, the ability of health systems to address the burden, the inability to undertake social distancing and frequent hand washing in poor communities, and potential impact on the severity of disease by highly prevalent diseases like tb or hiv are pressing. further the impact of the epidemic and on lockdowns on economies and on poverty remain critical issues for child health. this report was based on the podcast recorded by the american thoracic society. all authors contributed equally so all needs to get credit as first authors. unique epidemiological and clinical features of the emerging novel coronavirus pneumonia (covid- ) implicate special control measures covid- : towards controlling of a pandemic korean society for antimicrobial therapy, korean society for healthcare-associated infection control and prevention sars-cov- infection in children characteristics of and important lessons from the coronavirus disease (covid- ) outbreak in china summary of a report of cases from the chinese center for disease control and prevention world health organization. infection prevention and control during health care when novel coronavirus (ncov) infection is suspected infection-prevention-andcontrol-during-health-care-when-novel-coronavirus-(ncov)-infection-issuspected- interim infection prevention and control recommendations for patients with suspected or confirmed coronavirus disease (covid- ) in healthcare settings universal masking in hospitals in the covid- era brief report: international perspectives on the pediatric covid- experience the authors declare that there are no conflict of interests. all authors have contributed equally to the content and preparation of the manuscript, therefore, would like to receive credit as first authors. http://orcid.org/ - - - ralph epaud http://orcid.org/ - - - paul e. moore http://orcid.org/ - - - x key: cord- -u mlee u authors: nyasulu, juliet; pandya, himani title: the effects of coronavirus disease pandemic on the south african health system: a call to maintain essential health services date: - - journal: afr j prim health care fam med doi: . /phcfm.v i . sha: doc_id: cord_uid: u mlee u south africa had its first coronavirus disease (covid- ) case on march in an individual who travelled overseas. since then, cases have constantly increased and the pandemic has taken a toll on the health system. this requires extra mobilisation of resources to curb the disease and overcome financial loses whilst providing social protection to the poor. assessing the effects of covid- on south african health system is critical to identify challenges and act timely to strike a balance between managing the emergency and maintaining essential health services. we applied the world health organization (who) health systems framework to assess the effects of covid- on south african health system, and proposed solutions to address the gaps, with a focus on human immunodeficiency virus (hiv) and expanded programme on immunisation (epi) programmes. the emergence of covid- pandemic has direct impact on the health system, negatively affecting its functionality, as depletion of resources to curb the emergency is eminent. diversion of health workforce, suspension of services, reduced health-seeking behaviour, unavailability of supplies, deterioration in data monitoring and funding crunches are some of the noted challenges. in such emergencies, the ability to deliver essential services is dependent on baseline capacity of health system. our approach advocates for close collaboration between essential services and covid- teams to identify priorities, restructure essential services to accommodate physical distancing, promote task shifting at primary level, optimise the use of mobile/web-based technologies for service delivery/training/monitoring and involve private sector and non-health departments to increase management capacity. strategic responses thus planned can assist in mitigating the adverse effects of the pandemic whilst preventing morbidity and mortality from preventable diseases in the population. in south africa, since march , when the first coronavirus disease (covid- ) case was reported, cases have increased to over at the time of writing this article. this pandemic has called for extra mobilisation of resources to curb the disease and overcome financial loses whilst providing social protection to the poor. for decades, the south african health system has shouldered a quadruple burden of diseases (much of which is preventable), with mother and child health indicators far from accepatable targets. , the south african primary healthcare provides both curative and preventive health services. these include under-five child health services, such as growth monitoring and expanded programme on immunisation (epi); reproductive health services such as family planning, cervical and breast cancer screening, antenatal, labour and postnatal care services; chronic disease care for both communicable and non-communicable diseases including human immunodeficiency virus (hiv) services; and many other health promotion, preventative and curative services. it is concerning that out of . million hiv-positive people living in south africa, about . million people are on antiretroviral treatment (art), with one-third ( . million) not virally suppressed. the current evidence indicates that those virally suppressed are not at higher risk. however, in addition to . million, we do not know about the other million not on art, who probably will be at higher risk of severe covid- infection. , south africa has existing antiretroviral (arv) and vaccine stock-out challenges because of supply chain constraints. , , , in addition, gaps have been identified around low routine immunisation coverage resulting in outbreaks of vaccine south africa had its first coronavirus disease (covid- ) case on march in an individual who travelled overseas. since then, cases have constantly increased and the pandemic has taken a toll on the health system. this requires extra mobilisation of resources to curb the disease and overcome financial loses whilst providing social protection to the poor. assessing the effects of covid- on south african health system is critical to identify challenges and act timely to strike a balance between managing the emergency and maintaining essential health services. we applied the world health organization (who) health systems framework to assess the effects of covid- on south african health system, and proposed solutions to address the gaps, with a focus on human immunodeficiency virus (hiv) and expanded programme on immunisation (epi) programmes. the emergence of covid- pandemic has direct impact on the health system, negatively affecting its functionality, as depletion of resources to curb the emergency is eminent. diversion of health workforce, suspension of services, reduced health-seeking behaviour, unavailability of supplies, deterioration in data monitoring and funding crunches are some of the noted challenges. in such emergencies, the ability to deliver essential services is dependent on baseline capacity of health system. our approach advocates for close collaboration between essential services and covid- teams to identify priorities, restructure essential services to accommodate physical distancing, promote task shifting at primary level, optimise the use of mobile/web-based technologies for service delivery/training/monitoring and involve private sector and nonhealth departments to increase management capacity. strategic responses thus planned can assist in mitigating the adverse effects of the pandemic whilst preventing morbidity and mortality from preventable diseases in the population. preventable diseases, such as measles, in south africa. anecdotal reports show that there is a decline in access to art from march by those already initiated on art. for example, some districts supported by right to care (rtc), a president's emergency plan for aids relief (pepfar) partner for gauteng province, show increasing numbers of missed appointments to collect art. similarly, epi and other essential services are also likely to be affected. fear of contracting covid- , the physical distancing policy and a shift in focus of service providers from basic essential services to covid- pandemic demands may be the reasons for the decline in access to essential services. emergence of the covid- pandemic risks the worsening of existing gaps and increasing deaths as shown in the previous ebola outbreaks. , the resilience of health system to timely adapt and strike a balance between maintaining routine services and coping with the pandemic is crucial to mitigate the damage. currently, there is a rapid and overwhelming increase in strain on the health system because of covid- , overstretching the capacity of healthcare workers to operate effectively. , this article looks at the possible effects of covid- pandemic on the south african health system and proposes possible solutions to maintain the delivery of essential health services whilst fighting the pandemic, with a specific focus on hiv and epi. we believe that maternity care, child care (e.g. immunisation) and hiv services stand out as the most critical markers and a proxy for the strength of a health system, particularly in the context of south africa. , , resilience of a health system is indicated by its ability to offer basic healthcare services to pregnant women, children and people with hiv. these groups are comparatively more vulnerable and contribute to a high burden of morbidity and mortality at a population level. lessons from previous epidemics such as ebola have shown that when there is a threat to a health system, these groups are affected first and to a higher extent. moreover, because of our experience and expertise in working with hiv and immunisation, we selected them as priority services and focus of this article. we applied the world health organisation (who) health systems framework and its six building blocks to assess how covid- pandemic has affected the south african health system ( figure ). using the documented existing service delivery gaps, we analysed epi and hiv programmes as examples of priority essential health services to be maintained by south africa during this emergency period. , , in addition, solutions to strike a balance between responding to covid- pandemic and maintenance of these essential services are proposed. this article followed all ethical standards for a research without direct contact with human or animal subjects. pandemic and essenƟal health service delivery how can emergency and essenƟal health services teams collaborate? which essenƟal services need to be prioriƟzed, postponed and suspended? how do we tap from resources outside the health systems and ensure mulƟsectoral collaboraƟon? how do we maximize the potenƟal of web and mobile based technologies for service delivery? how do we maintain quality monitoring of exisƟng essenƟal services during emergency? how do we Ɵmely integrate emergency responses with priority essenƟal services? what are the exisƟng gaps and strengths in essenƟal services (within each who building block)? what is the current capacity of the health system to mobilize resources? currently, which are the worst performing provinces, districts and faciliƟes needing more aƩenƟon? which populaƟon group will be most affected? (e.g. infants, migrants) what emergency responses will be needed for covid- ? how will covid- responses affect health system's delivery of essenƟal services? a. essential services not prioritised because of competing interests, e.g., immunisation campaigns paused world health organization proposes outreach mechanisms to ensure delivery of essential services, including immunisations and hiv services. for example, auxiliary nurses can do field-based immunisations (at rural health posts closer to community) rather than children crowding at clinics. human immunodeficiency virus experts advise that male circumcision can be paused whilst harm reduction and condom distribution and hiv treatment services need to be maintained with modifications that will reduce contact with service providers. currently, south africa is implementing central chronic medicines dispensing and distribution (ccmdd) programme whereby stable patients collect their chronic medications at different pick-up points near them outside the health facility. we recommend that ccmdd must be maximised to reduce physical contacts with service providers. immunisation campaigns can be modified to reduce huge numbers at once. consider integrated community-based outreach platforms offering immunisation services. b. covid- physical distancing policy compels population to defer healthcare seeking for essential routine services like hiv and epi integrate essential services with covid- services at facility and community levels. for example, involve nurses delivering epi and hiv services in screening for covid- and reporting cases. identify and prioritise vulnerable communities including infants, poor and the elderly for essential services. for example, maximise the use of social protection grants available during the emergency to promote access by the vulnerable groups. generate a country-specific list of essential services for sa (based on context and supported by who guidance and tools). prioritise current worse-performing provinces, districts and facilities, which need more attention and resources for delivery of essential services. shift focus from conducting face-to-face, manual and paper-based routine operations and monitoring to utilising information technology and web-based platforms for maintaining services, for example, health promotion and prevention messages through mobile technology. ensure positive health-seeking behaviour and adherence to care by maintaining population's trust in the capacity of the health system, to safely meet essential needs and to control infection risk in health facilities. the communities should be sensitised and reassured through media, text messages and platforms like religious and other existing community structures. (who operational guidelines) intensive covid- screening for health service providers. prioritise and ensure adequate supply of personal protective equipment (ppe) for health workers. explore ways to support those needing self-isolation and quarantine whilst protecting their family/household. consider short, web-based training for health workers in covid- screening, first-line treatment, referral guidelines, quarantine/ isolation policies and personal protection through smart phones (based on videos/apps). they also need to be trained on how to assure/motivate/counsel the clients because they are the frontline contacts. c. shortage of staff from essential services because of redeployment towards covid- response consider task shifting and scope expansion where possible to improve access to care ( ) -for example, enrolled nurses and enrolled assistant nurses could take up health prevention/promotion as well as curative tasks from professional nurses, for example, immunisation. use of qualified health workforce resident in south africa but not working, to be recruited. part time health workforce to be asked to work full time. utilise the senior health workforce students from training institutions to alleviate staff shortage pressures. maximise health workforce from the non-governmental partners like provincial and district pepfar collaborations, defence, red cross, etc. clinical associates, senior students from nursing colleges and interns can be deployed on a short-term basis and, if possible, accelerate early certification without compromising quality. redistribute and redeploy staff from non-affected areas, or high-performing districts to low-performing districts. reassurance from department of health, small incentives for those health workers who contribute to both phc and covid- response. explore ways of acknowledging and appreciating the health workforce. a worsening of the quality of existing data in public health system minimise paper-based reporting and data collection considering physical distancing strengthen online, web-based information systems for monitoring and progress of hiv and epi programmes, which can be directly used by health workers and data can be submitted through smart phones to a centralised server, which is accessible to all project managers and decision-makers. b. competing interests leading to a shift in focus to monitor the covid- data currently in greatest demand during the emergency, ensure monitoring of ongoing delivery of essential health services to identify gaps and provide timely response. prioritise, in this case, epi, hiv and other critical indicators in the dhis that need to be essentially monitored and leave out those indicators the monitoring of which can be delayed, such as male circumcision. c. lack of time for quarterly reviews to monitor progress on essential services to identify and address gaps, for example, health facility assessments, imci health worker supervision, etc. decentralise quarterly reviews at facility level -promote internal reviews of routine essential services (designate a team of nurses led by facility managers) if supervisors cannot visit the clinics and provide online feedback to managers. web-based data reviews through zoom/ms team/skype/google meet, etc., and other platforms will save time without disturbing physical distancing. d. surveillance and reporting of afp and vaccine preventable diseases might not be ensured maximise online tools for monitoring and reporting of cases of acute flaccid paralysis (afp) for polio, measles, etc. (e.g. apps, web-based software) involve private clinics and gps in reporting and surveillance. a. south africa has existing arv and vaccine stock-out challenges because of supply chain constraints. , , , prioritise the worst-performing provinces on arvs, vaccines and other essential medicines stock-outs. collaborate with private health sector, pharmaceutical companies to maximise contribution and utilise their platforms. use of advances in technology to improve supply chain management could be linked with current initiatives such as momconnect. stock-outs for medicines and vaccines can be reported by facilities or districts online through web-based platforms which are monitored by the district supply chain managers and supplies could be procured accordingly. for example, blood information and management application (bima) in bangladesh takes online demand for blood and manages procurement. b. shortage of covid- essential protective wear for healthcare workers has already been reported as manufacturers fail to meet demands enhance and promote local manufacturing of ppes. capitalise on buffer system. economy shrinking coupled with high financial constraints to cope with the pandemic may lead to fiscal constraints on essential health services spending for hiv and epi presidency and department of finance need to coordinate with department of health and decide on diverting any funds available in contingency or from other non-essential departments, for example, tourism, and create extra budget heads for maintaining essential health services such as procuring arvs or vaccines. divert surplus funds under hiv and epi heads towards poor performing districts and provinces for extra support (e.g. run a mobile unit for vaccination or conduct a community-based catch-up campaign). strengthen private and public health sector partnership to ensure that the public health system taps from the available resources in the private sector. initiate and promote covid- fundraising activities at local, regional and national levels. for example, sa has introduced solidarity fund where individuals and firms are donating resources to meet the needs of the poor, and at the time of writing this article, r . billion had been raised with a target of r bn. table continues on the next page → we applied the who health systems framework to highlight strengths and gaps in the epi and hiv service delivery system and explain how these are affected with the emergence of the covid- pandemic. we have also proposed possible solutions on how to deal with these challenges. the questions raised in the above conceptual framework do not specifically direct our analysis; rather, they serve as a generic guideline for consideration by health managers and stakeholders in order to maintain primary health services during a pandemic. table summarises these gaps and possible solutions to maintain essential service delivery, with a focus on hiv and epi. the emergence of the covid- pandemic has put great burden on the health system, negatively affecting its functionality. we propose the who health systems framework as an approach for assessing and prioritising services by health systems to strike a balance between the responses to covid- pandemic and delivery of quality essential healthcare services, with a focus on epi and hiv programmes. firstly, representation and close collaboration between the covid- and the essential services teams at all levels are recommended. these teams together will need to identify priority essential services within the two programmes and decide which services are to be continued, postponed or suspended. at this time, identification of how the emergency is affecting the health system and which geographic areas and vulnerable groups should be prioritised are critical. , application of the who health systems building blocks will provide a systematic and comprehensive approach to the identification of these gaps. the next step is to identify and implement solutions to address the gaps worsened or caused by the covid- emergency response. for instance, the redeployment of health workforce, coupled with others being infected with covid- , depleted the already existing shortage. therefore, considering task shifting, integration of services, utilisation of senior students, tapping from ngo partners and government workforce outside the department of health would alleviate the health workforce shortage. , , , , , , the most important task is to provide support to the available health workforce in different aspects needed. admittedly, the covid- physical distancing currently advocated for puts hiv-positive individuals and parents in a dilemma to defer routine appointments, worsening the current gaps in hiv/epi programme. therefore, in order to ensure positive health-seeking behaviour and adherence to care, there is a need to maintain population's trust in the capacity of the health system to safely meet essential needs and to control infection risk in health facilities. this requires training of health service providers in providing essential services with extra safety to control the spread of covid- , accompanied by communication with the users and reassurance of access and safety of health services. in times of such pandemics, it is important to ensure that the vulnerable communities including the poor and the elderly have the ability to access these essential services. , furthermore, existing gaps in immunisation and hiv services including stock-outs have been established, which can worsen when dealing with the covid- pandemic. , we therefore propose service delivery approaches that do not attract crowds like ccmdd and outreach services. , , we also suggest the need to minimise relying on manual operations and paper-based service delivery and monitoring, and utilise information technology and web-based platforms to monitor and conduct its routine operations. , end-user monitoring of the supply chain by patients and civil society has the potential to increase transparency and complement public sector monitoring systems. in conclusion, the resilience of the health system is a critical determinant of how a country responds to a pandemic. in emergencies like covid- , the ability of a health system to organization health systems framework). proposed solutions to maintain essential health services whilst responding to the pandemic a. depleted leadership capacity for essential services as programme managers had been redeployed to covid- . inter-sectoral collaboration -human resources from other non-health departments need to be involved to provide the required leadership and coordinate with health department. these could include department of finance, department of agriculture, department of education, ngo and multi-national partner institutions, for example, unicef and who. the use of other ministerial departments to complement the containment of the pandemic. for example, the ministry of water and sanitation to ensure that population including the hardest to reach ones have access to clean water and soap for handwashing. this can be accomplished in collaboration with the ministry of defence that can help in distribution. in addition, the ministry of information and education can support free online education, the ministry of telecommunications can generate awareness by media campaigns and telkom companies can be involved to provide mobile data free of cost to support information exchange and online management of health information, etc. department of health can also utilize senior students from medical, nursing and public health universities, clinical associates, interns and paediatrics registrars to assist with programme management and operations. they are better trained and equipped and can work in coordination with existing programme managers and leaders on a short-term voluntary basis to get a hands-on experience in public health and emergency response. b. decisions to navigate and strike a balance between the emergency covid- and essential services close collaboration between the covid- and essential services teams at all levels of management (national, provincial, district, sub-district and below) to identify and agree on the priority essential services that must maintain continuity during emergency period. national coordinators for hiv and epi need to adapt and implement who essential services guidelines to south african context and communicate with provincial and district-level programme managers on how to operationalise the modified guidelines in their respective areas. deliver essential services is dependent on the existing burden and baseline capacity of the health system. the existing high disease burden would put the south african health system in a fragile state to cope with the pandemic if timely adaptation actions are not taken. the approach proposed in this article, about using who building blocks to identify existing gaps, challenges and possible solutions, can be adopted by other low-and middle-income settings to identify priority actions in order to strike a balance between attending to a pandemic and simultaneously maintaining essential services. the authors envisage that applying these principles during such pandemics will lead to informed health systems decisions in striking a balance between emergency response and essential health service delivery, and maintaining of curative and preventive essential health services, which in turn will reduce morbidity and mortality from preventable and treatable diseases. national institute of communicable diseases (nicd); c escalation of measures to combat coronavirus covid- pandemic [press release]. government of south africa mortality trends and differentials in south africa from to : second national burden of disease study initial burden of disease estimates for south africa evaluating the performance of south african primary care: a cross-sectional descriptive survey setting the scene: some data on the hiv epidemic. th sa aids conference systematic review of the efficacy and safety of antiretroviral drugs against sars, mers, or covid- : initial assessment stock-outs of antiretroviral and tuberculosis medicines in south africa: a national cross-sectional survey nationwide shortage of vital vaccines causes concern the status of vaccine availability and associated factors in tshwane government clinics impact of vaccine stock-outs on infant vaccination coverage: a hospital-based survey from south africa annual measles and rubella surveillance review, south africa. natl inst commun dis public health surveillance bull right to care: coronavirus in sa: hiv-positives are skipping treatment and drastic drop in testing. africa's medical media digest life-saving vaccinations must not 'fall victim' to covid- pandemic -unicef chief no increased coronavirus risk for people with well-controlled hiv says who, but how will health systems cope? the health impact of the - ebola outbreak public health emergency preparedness: a framework to promote resilience covid- : operational guidance for maintaining essential health services during an outbreak: interim guidance geneva: who; c effects of brain drain on the south african health sector: analysis of the dynamics of its push factors everybody's business, strengthening health systems to improve health outcomes. who's framework for action latest who updates and guidance on covid- and hiv ongoing initiatives to improve the quality and efficiency of medicine use within the public healthcare system in south africa: a preliminary study integrated delivery of health services during outreach visits: a literature review of program experience through a routine immunization lens nurses art initiations (nimart) a tool to promoting art access and reducing the art service burden at referral hospitals improving health information systems for decision making across five sub-saharan african countries: implementation strategies from the african health initiative can mhealth improve access to safe blood for transfusion during obstetric emergency? coronavirus personal protective equipment shortage. maverick: styli charalambous health spending at a time of low economic growth and fiscal constraint. south afr health rev solidarity fund: unity in action ensuring access to quality health care in vulnerable communities supporting the health care workforce during the covid- global epidemic mobile devices and apps for health care professionals: uses and benefits what makes health systems resilient against infectious disease outbreaks and natural hazards? results from a scoping review the authors would like to thank prof. susan goldstein for her input in conceptualising the health systems gaps. this research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. data sharing is not applicable to this article as no new data were created or analysed in this study. the views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of any affiliated agency of the authors. the authors have declared that no competing interests exist. j.n. conceptualised the study and wrote the first draft. j.n. and h.p. were both involved in the writing of the manuscript and approval of the final version. key: cord- -kvxa lq authors: byock, ira title: heroism and hypocrisy: seeing our reflection with vision date: - - journal: j palliat med doi: . /jpm. . sha: doc_id: cord_uid: kvxa lq nan p eople who work in the field of hospice and palliative care are accustomed to being misunderstood. at parties or on planes, when people ask and we tell them what we do, their emotions range from ''bless your heart'' to ''i don't know how you do that.'' most of the time, the conversation mercifully moves on to other subjects. in practicing hospitalbased palliative care, ''the h word'' is something referring colleagues ask us to avoid when we introduce ourselves to a patient and family. ''they're not ready for hospice,'' they explain, and do not want us to be stained by that brush. indeed, based on marketing research it commissioned, the center to advance palliative care has advised palliative care providers to eschew the word ''hospice'' in describing what we do. but you can sense a shift in the cultural landscape. amid the covid- pandemic, hospice's new h word is hero! stripped of the illusion of security, the public sees the immediate and enduring value of palliative care, home health care, nursing home care, and hospice. i hope we own it. let us refrain from reflexively deflecting the compliments. it is culturally important for our field to be recognized as heroes. i have often thought our work was analogous to the vocation of firemen. in circumstances of serious illness, dying, and grief-from which reasonable people are running away-we rush in. we willingly walk close to the fire. we feel the heat and accept the risk of being personally singed. in calling our work heroic, the public gives voice to the values and personal attributes that human beings hold highest. you can hear it in the nightly boisterous celebrations for health care workers, the singing and horns and applause and, here in missoula, mont., the pm howls. these are healthy expressions of gratitude. own them. of course, nothing in tumultuous is simple. for all the plaudits coming our way, the searing honesty of this most terrible year also reveals our blind spots, flaws, and failures. the pandemic has demonstrated glaring health disparities suffered by people of color, people who are poor, and those who live or work in crowded conditions. they have always been there, well studied and documented, but somehow tolerated. in the wake of videotaped police killings of black people, we have been forced to reckon with endemic racism. every industry and profession, including our own, are being called to examine structural and cultural biases and the inequities we impose on black, latinx, and immigrant communities, as well as transgender people. we have been warned that such examinations will be uncomfortableindeed must be uncomfortable-if they are real. health care organizations are earnestly stepping up. by last spring, every organization's board and senior management were developing substantive position papers and diversity, equity, and inclusion plans. a steady stream of health care webinars, panel discussions, and podcasts are calling attention to assumptions and patterns of clinical practice that reflect implicit biases. these efforts are long overdue and entirely worthwhile. they are also insufficient. we have yet to witness an unblinking assessment of ubiquitous prejudicial business practices that are rooted in race, ethnicity, or gender. health care's sustaining contribution to the social disease of our time lies in the ways we treat and compensate direct care workers. about . million home health aides, personal care aides, and nursing assistants in the united states form the backbone of our health care system. many work for home care, nursing homes, and hospice companies. there are countless heroes among them who richly deserve to be held up as examples. however, at least until the pandemic, they were largely unseen. that needs to change. direct care workers are among the most poorly paid of any occupations in america, despite doing some of the hardest jobs in health care. in , wages for those providing intimate care for cleansing, toileting, dressing, and feeding frail elders and people with disabilities ranged from a median of $ . hourly ($ , annual) for personal care aides to $ . hourly ($ , annual) for certified nursing assistants. , corporate executives and legislators debate the complexities of determining a living wage. but this is not particle physics and reasonable estimations will suffice. there is even an app for that. m.i.t. researchers have developed a living wage calculator. nearly a fifth of direct care workers are officially poor, living below the federal poverty threshold for a family. fiftythree percent of these working adults require public assistance, including % who rely on medicaid and % who receive supplemental nutrition assistance. even before covid- , direct care workers had among the highest rates of on-the-job injuries of any occupation. in this pandemic, these heroes have often had to enter the homes and congregate living facilities of infected patients without sufficient masks, gowns, and gloves, thereby putting themselves and their own families at high risk. few have been accorded hazard pay. few have sick leave benefits. this is no way to treat heroes. because of the circumstances in which they live and work, direct care workers are sometimes unwitting vectors of the virus. their homes tend to be crowded. many can only find part-time positions-a feature that helps companies to limit benefits-and must, therefore, work at two or more locations to provide for their families. as a result, they are prone to transmit the virus to the multiple workplaces in which they give intimate care. is this tragedy the result of racism and sexism in health care? the short answer is yes. it is no coincidence that > % of direct care workers are women, nearly % are people of color and more than a quarter are immigrants. that does not mean that the corporate executives and bureaucratic managers who determine wages, hiring, and employment practices are overtly racist. accepting this distinction requires understanding the omnipresent influence on well-meaning individuals' attitudes and actions of the unending need to turn a profit from caring for frail, disabled, and dying americans. in the ''no margin, no mission'' mindset of america's health care culture, leaders believe they cannot afford to pay a living wage to all employees, that doing so would decrease their company's ebitda (earnings before interest, taxes, depreciation, and amortization), damage stock prices and risk lowering their bond ratings. within c-suites, any disagreement with this assumption is perceived as naive. leaders are not intentionally making decisions that harm women or people of color. the structural nature of racism and sexism renders the intentions of individual company executives irrelevant. the social upheavals of the pandemic, black lives matter, and pervasive racism and sexism represent opportunities to challenge long-held assumptions and reset expectations. the truest indicator of any organization's moral compass is not found in its mission or vision, but in its budget, particularly the line items devoted to personnel salary and benefits. boards of directors of health care companies, including both for-profit and not-for-profit entities, must require that all workers are paid a living wage and treated fairly, regardless of the opinion of the market or bond rating agencies. each company's diversity, equity, and inclusion policy should mandate transparent public reporting of direct care workers' median wages, benefits, and annual turnover rates, along with the proportion of part-time to full-time employees. in addition to days cash on hand, boards should require leadership to report days protective equipment on hand. sick leave, family leave, and hazard pay for working in hazardous conditions should be required benefits of employment. unless and until we stop making excuses for our mistreatment of the least powerful among us, the health care industry will be unable to own its ignominious contributions to endemic racism and sexism that have been part of sustaining this pandemic. this statement is at once an indictment and confession. no individual of seniority and years in health care can credibly deny complicity, if only in acquiescence to the status quo. if we are to authentically address issues of diversity, equity and inclusion, we must cut the chains of margin-driven care and model the values we espouse. only then will we be able to chart a course to a more healthy and equitable future. there is an h word for health care company leaders who call their frontline caregivers heroes, while neglecting to protect their health or pay them a living wage: hypocrites. more on messaging: getting the care to the patients. webinar presented at the: center to advance palliative care i see you. i hear you. and i ache for you washington/-i-see-you-i-hear-you-and-i-ache-for-you- - .aspx (last accessed bureau of labor statistics: home health aides and personal care aides. occupational outlook handbook bureau of labor statistics: nursing assistants and orderlies. occupational outlook handbook massachusetts institute of technology: living wage calculator the invisible covid workforce: direct care workers for those with disabilities. the commonwealth fund immigrants and the direct care workforce: paraprofessional healthcare institute key: cord- - t mu s authors: wynne, keona jeane; petrova, mila; coghlan, rachel title: dying individuals and suffering populations: applying a population-level bioethics lens to palliative care in humanitarian contexts: before, during and after the covid- pandemic date: - - journal: j med ethics doi: . /medethics- - sha: doc_id: cord_uid: t mu s background: humanitarian crises and emergencies, events often marked by high mortality, have until recently excluded palliative care—a specialty focusing on supporting people with serious or terminal illness or those nearing death. in the covid- pandemic, palliative care has received unprecedented levels of societal attention. unfortunately, this has not been enough to prevent patients dying alone, relatives not being able to say goodbye and palliative care being used instead of intensive care due to resource limitations. yet global guidance was available. in , the who released a guide on ‘integrating palliative care and symptom relief into the response to humanitarian emergencies and crises’—the first guidance on the topic by an international body. aims: this paper argues that while a landmark document, the who guide took a narrowly clinical bioethics perspective and missed crucial moral dilemmas. we argue for adding a population-level bioethics lens, which draws forth complex moral dilemmas arising from the fact that groups having differential innate and acquired resources in the context of social and historical determinants of health. we discuss dilemmas concerning: limitations of material and human resources; patient prioritisation; euthanasia; and legacy inequalities, discrimination and power imbalances. implications: in parts of the world where opportunity for preparation still exists, and as countries emerge from covid- , planners must consider care for the dying. immediate steps to support better resolutions to ethical dilemmas of the provision of palliative care in humanitarian and emergency contexts will require honest debate; concerted research effort; and international, national and local ethical guidance. abstract background humanitarian crises and emergencies, events often marked by high mortality, have until recently excluded palliative care-a specialty focusing on supporting people with serious or terminal illness or those nearing death. in the covid- pandemic, palliative care has received unprecedented levels of societal attention. unfortunately, this has not been enough to prevent patients dying alone, relatives not being able to say goodbye and palliative care being used instead of intensive care due to resource limitations. yet global guidance was available. in , the who released a guide on 'integrating palliative care and symptom relief into the response to humanitarian emergencies and crises'-the first guidance on the topic by an international body. aims this paper argues that while a landmark document, the who guide took a narrowly clinical bioethics perspective and missed crucial moral dilemmas. we argue for adding a population-level bioethics lens, which draws forth complex moral dilemmas arising from the fact that groups having differential innate and acquired resources in the context of social and historical determinants of health. we discuss dilemmas concerning: limitations of material and human resources; patient prioritisation; euthanasia; and legacy inequalities, discrimination and power imbalances. implications in parts of the world where opportunity for preparation still exists, and as countries emerge from covid- , planners must consider care for the dying. immediate steps to support better resolutions to ethical dilemmas of the provision of palliative care in humanitarian and emergency contexts will require honest debate; concerted research effort; and international, national and local ethical guidance. background humanitarian crises and emergencies, events that are often marked by high mortality, have until recently excluded palliative care-a specialty focusing precisely on supporting people with serious or terminal illness or those nearing the end of life. awareness of this paradox has recently been rising and a growing body of literature has been calling for the inclusion of palliative care into humanitarian and emergency responses. [ ] [ ] [ ] [ ] [ ] [ ] [ ] a seismic shift of attention is also happening now across all parts of the world-not only in pre-existing humanitarian crises-in the context of the covid- pandemic. as of may , the international association for hospice and palliative care (iahpc) lists over 'resources relevant to palliative care and covid- '. often unknowingly, this growing attention to palliative care revives the history of modern (western) humanitarianism in emergency and crisis response. in one of the humanitarian sector's formative documents, henry dunant depicts the harrowing suffering he encountered in stumbling across the battle of solferino in . dunant suggested that compassionate care shown in accompanying and soothing the dying should be the foundation of humanitarian action. in the + years since dunant's experience, the capacity of both modern medicine and the broader humanitarian response to save lives has increased dramatically and continues to do so. saving lives has become the paramount goal for both. since the middle of the th century however, medicine has also evolved a branch specifically aimed at alleviating the suffering of those who cannot be cured and/or are dying. this is palliative care, which aims to prevent and relieve physical, emotional, social or spiritual suffering associated with any chronic or life-threatening illness and to promote dignity in suffering, death and dying. humanitarianism and palliative care share both fundamental goals around easing suffering and upholding dignity, and a moral root in the recognition of our common suffering, fragility and humanity. powell et al suggest four types of humanitarian scenarios for which the provision of palliative care is especially relevant: ( ) protracted conflicts where people endure life-limiting illnesses; ( ) acute mass-casualty events where individuals are triaged based on likelihood to survive; ( ) communicable disease outbreaks with limited therapeutic intervention options; and ( ) within refugee and displaced persons camps. the ubiquity of such scenarios and benefits of palliative care to these populations demand the inclusion of palliative care within the humanitarian response. at the time of editing this article, we are in the midst of the covid- pandemic, an infectious disease caused by a newly discovered virus in the coronavirus family, for which there is currently no vaccine and no specific antiviral medicines. as of today ( may ) , the data from the who are for confirmed cases; confirmed deaths; and countries, areas or territories with cases. from a palliative care perspective, this means that over , covid- deaths, each of the critical care cases, and many more unrecorded patients who are dying or have died with or without covid- in the time of the pandemic, should have been considered for and typically offered palliative and end-of-life care. this is unlikely to be happening on such a large scale. yet health systems across the world have had, for about a year and a half, clear guidance on the crucial importance of palliative care in humanitarian emergencies and the need to include palliative care in emergency preparedness. in september , who released a guide on 'integrating palliative care and symptom relief into the response to humanitarian emergencies and crises' -the very first guidance document on the topic by a pre-eminent international body. the publication of the guide was a landmark moment for the field of palliative care in humanitarian settings. if governments, healthcare providers and humanitarian organisations have been swift to begin integrating its philosophy and practical recommendations in their planning, their efforts are likely to be rewarded in the current pandemic context. yet a little over a year is almost as brief as the blink of an eye for the system transformation required, without the dramatic force of events as the ones we see unfolding. we are not aware of evidence of the guide's uptake in the aftermath of its publication, including in responses to covid- . indeed, any reference to the guide or to palliative care are omitted from recent covid- emergency and humanitarian response plans (eg, who's 'covid- operational guidance for maintaining essential health services during an outbreak' and the un office for the coordination of humanitarian affairs' 'global humanitarian response plan covid- '). we hope the guide's application has been far more widespread than the lack of references and formal evaluations may suggest, but this remains, for now, an open research question. and while no first major document of its kind could have withstood the challenge of covid- , we still need to scruitinise the guide for shortcomings and opportunities to improve on them and not only criticise the (likely) limitations of its uptake. some of the guide's most important shortcomings concern, from our perspective, issues of ethics. this is the focus of our paper. we argue that the who guide has employed, predominately, an ethical lens shaped by clinical bioethics, with its concern for the rights and well-being of individual patients and their interactions with healthcare providers. we propose that a future version of the guide will be dramatically enhanced in its ethical discussion by the incorporation of a population-level bioethics lens, among others. in a manner that is both contrasting and complementary to clinical bioethics, population-level bioethics focuses on the obligations of society to its members as individuals and groups. one of the fundamental contentions of population-level bioethics is that different segments or subgroups within a society will require varying 'right actions' due to differential access, availability and opportunity to use resources. we suggest that palliative care has limited chances of becoming a recognised and integrated component of the humanitarian and emergency response unless we explore such obligations and the dilemmas associated with them. we are also forced to explore those issues now. many healthcare professionals, emergency services staff and humanitarian workers, as well as organisational leaders and policy-makers are shaken by powerlessness, guilt and fear from witnessing covid- deaths which could have been avoided with better preparation; from being aware of the suffering and loneliness of those who are dying, while all available staff are needed to fight for the lives of those with higher chances of survival; or, with a growing likelihood, from contemplating decisions about withholding or withdrawing critical treatment because of severe resource limitations. they are grappling with what slim calls 'hellish choices'. doctors and ethicists across countries such as italy, the usa, the uk and australia have, expectedly, quickly seen the need to develop ethical guidance and decision-making frameworks to guide tough resource allocation and triage choices. [ ] [ ] [ ] [ ] [ ] [ ] we are living and witnessing harrowing experiences and tradeoffs relevant to palliative care on a daily basis, yet these dilemmas did not receive a mention in the who guide. overall, the guide lacked a basic recognition of their existence, acuity and, potentially, ultimate irresolvability. and while we could not have imagined them easily on a global scale, they were painfully familiar to anyone who has worked in a humanitarian crisis or emergency. it is as if the issues we wanted to avoid by not thinking of the worst came back to haunt us. our analysis begins with a summary of the ethical discussion in the who guide. we then present briefly the distinct visual fields revealed by a clinical bioethics lens and a population-level bioethics lens. we describe in greater detail the population-level bioethics perspective, as it is relatively unfamiliar in the broader ethics community and often misperceived as a form of utilitarianism in a healthcare context. (to some degree, this may be an issue of nomenclature-the name of 'population-level bioethics' does not do justice to the key considerations underpinning the approach.) we argue that the pattern of representation of ethical issues in the who guide is consistent with over-reliance on a clinical bioethics lens. the core of the paper then outlines four sets of ethical concerns and dilemmas around the provision of palliative care in humanitarian emergencies and crises which become more visible once we expand our lens to think about who comprises the entirety of a population. these sets of concerns and dilemmas arise in relation to ( ) rationing, ( ) patient prioritisation, ( ) euthanasia in the context of resource limitations and ( ) legacy inequalities, discrimination and power imbalances. we conclude with suggestions on how to broaden the debate. we offer neither in-depth articulation, nor resolutions to these concerns. rather, we highlight the value of considering health as a social, cultural and historical phenomenon in addition to a biological one. the complexity of the issues deepens further when we consider the multiple social identities that intersect in the same members and groups within a population. we are confronted with ruefully complex, disturbing, even heartbreaking challenges. yet until the covid- pandemic, these challenges were not openly discussed in the context of palliative care-including in the who guide which is our main focuseven if they were a way of life for many humanitarian and emergency workers and intuitively sensed by individuals external to the sectors. and while satisfactory solutions may not be forthcoming for a long while, we can still debate more openly, think more critically and creatively, and take more of the little steps that allow us to act more compassionately and fairly. we may also acquire greater wisdom and humility, which tend to come with clearer awareness of our limitations in situations where normal life has crossed into chaos. though multifaceted and beyond the focus of our paper, it is important also to have some clarity on what defines or constitutes a humanitarian emergency or crisis. a situation is generally labelled a humanitarian emergency or crisis if international aid is required from donor governments or philanthropic organisations (the alternative is a local or national emergency); and where the humanitarian response comprises the formal system of local, national and international non-governmental organisations, united nations bodies, the international red cross and red crescent societies, military units and international disaster response teams. the types of emergencies and crises the formal and modern humanitarian sector is designed to respond to include conflicts, natural or man-made disasters, disease epidemics and the casualities and mass displacement that may be caused by any of these. crises may be acute or chronic/protracted, and they may be sudden (such as an earthquake) or slow onset (such as a drought). a 'complex' humanitarian emergency is a more recent term to define those emergencies with multiple causes, and which destroy the integrity of whole societies and systems, requiring a system-wide response. poorer countries constitute the majority of humanitarian crises, with their reduced capacity to prepare, respond and recover, although covid- has necessitated an international response in some richer countries, for example, medecins sans frontieres' (msf)'s interventions in italy, spain and belgium. it is our understanding that the who guide intends to speak to humanitarian health workers operating within this formal humanitarian system. bioethics has always engaged with dilemmas at the level of both the individual clinical encounter and the health/illness experiences of populations and groups. some topics, and palliative care is a case in point, reside simultaneously in both subfields. clinical bioethics concerns itself with individual and patients' rights, whereas population-level bioethics includes consideration of the obligations of society to its members as individuals and groups. this shifts the focus from 'the relationship and interactions of individual patients and their physicians' to the social determinants of health, including but not limited to, socioeconomic status, environmental and working conditions, and social exclusion. clinical bioethics stipulates that a just outcome is obtained if an individual's needs are met, while population-level bioethics requires that the needs of the whole population are met. the broader scope of population-level bioethics allows for ethical analyses to consider the extent, direction and distribution of health resources, with special emphasis given to the least healthy populations. the rise of population-level bioethics parallels the rise of population health sciences. the two are underpinned by shared theoretical assumptions about how the world works and how the world should work and the impact this has and will have on the health of populations, groups and individuals. it is thus helpful to consider the defining features of population health sciences in order to contextualise population-level bioethics. the scholarly and practical field of 'population health' has its roots in traditional public health, but is, in many ways, a critical response to the latter's philosophical leanings. valles traces its origin to a reaction against public health, with its heavily biomedical and, by extension, individual-centred approach. population health has developed as a distinct alternative that 'is fundamentally concerned with the social structural nature of health influences, and, although it is embodied in the health outcomes experienced by specific individuals, the domains of influence that shape health experiences transcend the characteristics or circumstances of any one individual'. the biomedical model situates disease and its causes solely within biological, chemical and physical phenomena. it is characterised by a philosophical and methodological reductionism that espouses that the sum is best explained by the parts. such a perspective leads to public health interventions aimed at 'prioritising the development and distribution of drugs and devices that can 'fix' any broken tissue'. intellectual and material resources are disproportionately allocated towards medical interventions as opposed to policies and health interventions that would address the social determinants of health. philosophically, the practice of biomedicine, which relies heavily on the biomedical model, finds its primary underpinnings in deontology; that is, the duty one person has in relation to another in a specific situation. ideally, this does not mean that there is little regard for the good of the population. in practice, however, the good of society is often secondary to the care and advocacy for a specific patient. this narrow conceptualisation of deontology translates well in the context of individual clinical encounters but fails in areas of work focused on the entire population. a broader application of the deontological model, one that assumes that populations should operate based on rules and intent, still falls short of the needs of ethical decisionmaking about population health. rules are stringent and inflexible. alone, deontology does not allow sufficient room for the tradeoffs that must be considered to maintain population health. the biomedical model is also compatible with a utilitarian framework. within the latter, the goal of public health is to achieve the 'good' for the majority of the individuals within a population. indeed, bioethicists have argued that it is utilitarian justifications that underlie public health interventions, more specifically, paternalistic interventions aimed at altering behaviour to maximise the overall good. utilitarian principles are frequently considered the most rational and intuitively 'right' at the level of population health, even if acknowledged as hard, potentially excruciatingly so, to apply vis-à-vis the specific individuals whose well-being or lives are sacrificed in their application. less conspicuously, utilitarianism operates under the assumption that the health of the population is simply the sum of the health of its individuals, with no consideration for the impact of, for instance, cultural and societal history, power dynamics or social status. if health is socially patterned, and there is overwhelming evidence that it is, we should expect unjust differences in health among subgroups based on social identity (eg, race, gender, nationality, etc) and work to eliminate these differences. a utilitarian framework that prioritises the 'utility' or 'health of the majority' may do very little to eliminate health disparities. the goal of population health is to reduce and eliminate health-related gaps between groups. as a result, the discipline does not concern itself with either individual 'duties' or overall utility but with equity. the inclusion of equity mandates that particular attention is paid to the importance of individual, familial, cultural and societal history, as each of them separately and all of them together can result in different 'starting points'. the focus is on health and on social, environmental and biological factors that influence health as opposed to healthcare (care for the ill). additionally, as 'individual health and population health dynamically and mutually affect each other over a gradual passage of time', the shifts of focus from individuals to populations and vice versa are a key analytical pattern. unlike traditional paternalistic public health, population health also advocates for unprecedented multidisciplinary and cross-sector collaboration. importantly, the weight it gives to the lived experiences and resources of citizens and communities is on a par with that given to scholars or organisations. respect for persons ► all patients' dignity and human rights must be respected. ► health professionals should provide patients with all health-related information, respect their decision-making and provide appropriate recommendations. ► patient's health-related information should remain confidential. non-maleficence ► health professionals should only pursue interventions that provide more good than harm. ► all patients should have access to palliative care to minimise suffering. expectant patients should only receive palliation. ► never discriminate on the basis of ethnicity, religion, gender, age or political affiliation. ► avoid complicity with torture (political ethics?) beneficence ► work to provide the patient with the most good by meeting their physical, psychological, social and/or spiritual needs. ► anticipate and prevent future suffering. ► protect from violence and coercion (political ethics?) ► show great judiciousness when the good of the patient or family may be in conflict with the public good (eg, infectious diseases). justice ► similar patients should be treated similarly regardless of ethnicity, religion, gender, age or political affiliation. ► vulnerable patients may require more intensive services. ► health providers and aid workers may require increased health services due to added risks and burdens (principle of reciprocity). ► patient's autonomy should never be restricted unless for the greater good. solidarity ► a community, including the global community, should stand together to face common threats and overcome pathogenic inequalities. (political ethics?) non-abandonment ► medical care should be provided to all needy patients. ► expectant patients must be provided with palliative care. double effect ► an action intended to bring about a good outcome (alleviation of pain) is permissible despite the possibility of a harmful outcome (hastening death). the reason for undertaking such high-risk action must be grave (misuses of science?). statements in bold and italics refer to those that show an implicit concern for the health of populations and groups. statements in bold refer to those that are fully consistent with a perspective concerned with groups and populations. population health arguments typically revolve around a complex tension between two groups, for instance, high-risk versus low-risk, oppressed versus privileged, high-income versus lowincome groups. population health also acknowledges that, within a population, subgroups may require different resources for equity to be achieved, as subgroups too may be starting from vastly unequal innate and acquired resources. in light of the above, the goal of population-level bioethics can be construed as to investigate tensions between and within populations which result in inequitable health outcomes, and to uncover ethical solutions to health-related challenges which are equitable to all members of the population. unlike deontology or utilitarianism, population-level bioethics is not a moral framework, which prescribes the right type of action to be carried out. rather, it is a set of guiding questions and considerations that support actors in engaging critically with the health tradeoffs inherent in any society. these questions and considerations only become apparent when we take a perspective which allows us to identify previously unseen tensions between groups. once such a tension is pinpointed, a deontological or consequentialist (utilitarian) approach can be used to explain or rectify disparities between the groups that comprise the population. the 'right action' can then be, for instance, the implementation of structures and processes that eliminatein the short, medium and long terms-as many unjust health disparities between groups as possible. a distinguishing feature of population-level bioethics is that it does not stipulate that all persons within a population are subject to the constraints of a specific moral framework. rather, within a population, multiple moral frameworks may need to be applied simultaneously to achieve fairness. an additional requirement of population-level bioethics is thus to recognise and at times harmonise conflicting moral frameworks so that they may work together for the good of population health. table represents schematically the standing of population-level bioethics relative to deontology and utilitarianism. in the who guide, ethical issues are approached in a principlist fashion, consistent with a clinical bioethics framework. the seven principles addressed in it and the particular ways in which they are conceptualised are summarised in table . the guide also devotes a brief section to issues around 'ethics and culture', namely matters of unconscious biases, cultural values, stereotyping and human rights. to address clashes of prima facie duties or 'when there are two or more conflicting moral imperatives, neither of which takes clear precedence, and when obeying one imperative would result in transgressing another', the guide recommends ( ) inclusiveness ( ) communication ( ) transparency ( ) accountability ( ) consistency and ( ) ensuring comfort. finally, although the word 'euthanasia' is never explicitly mentioned, brief references in chapters and are made to 'hastening death' as unintentional, be it potentially foreseeable, outcome of attempts to ensure comfort in cases of 'severe, refractory symptoms in a patient with a terminal illness or mortal injury'. table summarises the ethical principles advanced by the who guide. bullet points in bold and italics represent principles underpinned by an implicit concern for groups and populations. 'normal' sentences represent principles that are solely clinical in nature (concerning the care for individual patients). principles in bold are consistent with a population-level bioethics lens. principles which seem to fall outside of both these frameworks are annotated with a question mark and a conjecture of the most proximate ethical debate, not least in view of the political context in which the guide was prepared (eg, political ethics?). four of the seven principles advanced by the guide-respect for persons, non-maleficence, beneficence and non-abandonmentare conceptualised partly with a clear focus on individual patients and individual clinical encounters, partly with a reference to a generic 'all'. the latter inclusion of the entirety of a population, however, remains at this minimalist level, as if the complexity created by that 'all' can be fully resolved through the rules pertaining to the 'one'. no attention is given, for instance, to potential tensions between the needs of individual patients, as arising from resource limitations and/or other socioeconomic and historical determinants of health. two of the remaining principles, justice and solidarity, are likely to require attention to population-level issues, as the presence of 'others' is an implicit or explicit element of their definitions (and those others will often belong to groups or subgroups, as per the concerns of population-level bioethics). yet the principle of solidarity is only couched in terms of a community, including the global community, facing threats together and taking a stance against inequalities. the principle of justice is specified mostly in terms of non-discrimination and priority treatment based on need, with no recognition for the sometimes insurmountable challenges their practice may encounter, as arising from systemic socioeconomic issues or resource constraints. finally, while the principle of double effect is framed in a generic way, it is specified through examples which focus on palliative care for individual patients. the limitations of the ethical debate in the who guide were, perhaps, a direct consequence of the limitations of the broader literature it could draw on at the time of its writing. while texts on palliative care in humanitarian contexts which also raise ethical issues and tensions are, in the current covid- context, multiplying daily (for a collection, see, for instance, ref. ), this was a severely underexplored topic before the current pandemic. previously, the state of the ethical debate on palliative care in humanitarian contexts was most prominently covered in a section of a broader systematic review by nouvet et al. the articles examined in the review raised issues around care for terminal patients, vulnerable populations, moral distress among providers, euthanasia and the tension between allocating resources for salvageable and nonsalvageable patients. a number of stakeholders had been stepping in to fill this void even before the covid- pandemic. for instance, elrha ( elrha. org), a global charity 'that funds solutions to complex humanitarian problems through research and innovation' funded a project by the humanitarian health ethics team-a multidisciplinary research team led by researchers at mcmaster and mcgill universities-to 'develop evidence clarifying ethical and practical possibilities, challenges, and consequences' faced by humanitarian organisations in the provision of palliative care and then create relevant guidance on the basis of it. palliative care in humanitarian aid situations and emergencies (palchase), a network serving as the current focal point for advocacy and debate about palliative care in humanitarian contexts, has also been committed to elucidating associated ethical issues. yet many of the above initiatives were only just underway, with their evidence and guidance still forthcoming. the covid- pandemic has triggered new levels of critical thinking and associated solutions around ethical issues and the place of palliative care, as least in rich country contexts. yet the specifics of pre-existing humanitarian contexts have hardly been addressed. much of the ethical debate which at some stage involves palliative care is focused on rationing and allocation of critical treatments such as ventilators and intensive care bedsunlikely considerations in many parts of the world where such high-cost treatments are not available. in what follows, we aim to contribute to this scarce but rapidly evolving debate by taking a population-level bioethics perspective and addressing issues of rationing; patient prioritisation; euthanasia in the context of resource limitations; and legacy inequalities, discrimination and power imbalances. when considering the equitable access to palliative care across the many different subgroups which comprise a population, we need to take into account the pre-existing resources available within a society as a whole. on the one hand, this defines what is equitable, while being achievable enough, within a particular society. on the other hand, it brings to the fore inequalities and injustice across societies that need to be addressed at a higher level. a framework of 'stuff ' (medication, equipment), 'staff ', 'space' and 'systems' [ ] [ ] [ ] has gained popularity in describing resource needs for palliative care during an emergency. here, we focus on resource limitations concerning stuff and staff. we first consider them at a broad societal/population level (against the background of expectations in the who guide), before looking into the implications such resource limitations have for tradeoffs between groups and subgroups within a population. the who guide recommends that palliative care services, with a specific emphasis on the provision of medication for pain relief and symptom control, be made available to everyone who may need them in humanitarian emergencies and crises, regardless of triage status. since who declared the covid- outbreak a global pandemic ( march ), even some high-income countries have experienced or are experiencing drug shortages. palliative care drugs are also used in intensive care units (icu). competition for these drugs has been reported as one of the reasons for a change of palliative care plans in a swiss hospital near northern italy. shortages of sedatives and drugs for the management of breathlessness have been commonly reported in the usa. the search for creative solutions, not devoid of other agendas, has even led to appeals to us death penalty states to release medications stockpiled in correctional facilities. even when no country-level drug shortages have been apparent (eg, in germany), national authorities have issued guidance against stockpiling to avoid the risk of shortages arising in some parts of the system from overpreparation in other parts of it. in a global supply chain, loss of drug production capacity in certain countries (as in china or italy in the current crisis), trade wars and national bans aimed at ensuring supply for one's own citizens can further limit the availability of drugs-for palliative care as for any other type of need-at critical timepoints. in the previous infectious disease crisis parts of the world where citizens have endured (and continue to endure), the ebola epidemic, the lack of morphine for pain relief has been well documented. the lesson seems to be currently repeated though, arguably, in part because ebola has not wreaked havoc on the developed world. the covid- pandemic may imprint such drug shortages in new and powerful ways on a global scale. the ambition of providing medication for pain relief and symptom control to everyone who may need them in humanitarian emergencies and crises is, however, up against vast inequalities in palliative care globally, as argued for persuasively in a lancet commission report. the need for improvement is particularly acute in low-income countries. between the years - , only . % ( . out of . metric tons) of morphine-equivalent opioids were distributed in lowincome settings. some of the key factors contributing to such gross global inequalities and unmet need are deep seated and/ or emotionally charged, such as unwarranted attitudes towards medically indicated opioid use; inequity in the global pricing of opioids; and advocacy limitations, since terminal patients can hardly engage in relevant activity. the covid- crisis may facilitate future efforts towards removing such roadblocks and improving palliative care services in parts of the world where these are hardly available. but it may also push palliative care further down the list of priorities. for instance, is providing short-term to long-term pain management and comfort care the best way to spend limited funds in humanitarian contexts, where even the basics of survival may be under threat? pain management drugs are inexpensive, as also emphasised by the who guide, yet in a resource-scarce environment, where critical priorities are pitched against one another, more money for drugs may still mean less money for housing, food, clean water and sanitation facilities. moreover, the health professionals who can appropriately prescribe and administer those drugs are not an inexpensive resource. a utilitarian standpoint would support this challenge against palliative care advocates, given that providing adequate nutrition to sustain life, sanitation facilities and clean water to prevent the transmission of communicable disease, and housing to protect individuals from the natural environment will increase population health. this tension is not at all theoretical: unmet needs for food, water, sanitation and hygiene in humanitarian contexts are well documented. even practitioners and staunch supporters of palliative care (as we, in fact, are) may find it hard to argue for pain relief versus bread/rice or water. asserting that we must do our best to meet all those needs does not make the current real-life decisions of funding allocation any less acute. a further question around the (non-specialist) staff who may be expected to deliver palliative care also arises. the physicians and various healthcare professionals of modern medicine believe that, above all, the purpose of their work is to cure. in a medical context, death is typically viewed as a failure. modern biomedicine also seems to be driven by a hubris that it is exclusively dedicated to survival, making the alleviation of suffering 'someone else's problem'. while the unquestioned supremacy of such beliefs needs to be challenged in medical education and healthcare as a whole, we need to work from the fact that most health professionals who are in active practice now, including those working in humanitarian crises or hospital emergency and critical care settings, are trained within similar sets of beliefs. the requirement for the provision of palliative care may then exacerbate the moral distress already prevalent in non-palliative healthcare workers, by imposing a responsibility that conflicts with their reason for being in the field. indeed, some of the most heart-breaking personal stories emerging from the covid- pandemic are those of emergency care clinicians who have chosen their field of work 'to save lives' and are now losing 'battle after battle' like never before. - there is also broader evidence that health providers may feel useless if unable to cure patients. moreover, the boundaries between medical specialties in humanitarian settings and emergencies are far less enforceable. healthcare workers may be reallocated from their specialities and expected to provide palliative care without prior experience and appropriate training. there will be numerous situations where the palliative care team cannot be 'just called in'-and especially so in pre-existing humanitarian crises. the authors of the guide recognise that healthcare workers may experience 'helplessness and distress' due to an inability to alleviate suffering. they also cite 'overworking, overwhelming emotional exposure, hardship in the field, lack of self-care and poor personal management' as reasons for humanitarian workers' burnout. however, they do not consider the possibility that the two might reinforce each other when palliative care services begin to be incorporated in the humanitarian and public health emergency response. the who guide recognises that essential palliative care drugs such as morphine are scarce in humanitarian situations. it too includes the lack of morphine during the ebola outbreak of - as an example of that scarcity. yet the authors seem to consider this a state of affairs that can easily be changed, since the legal basis is there-namely, the exceptions in international drug laws that govern the import and export of narcotics during emergencies. historically, the baseline amount of global narcotics is quite low. as the above examples of drug shortages and some of their explanations (such as competition with icu needs or loss of drug production capacity in key country producers) have begun to demonstrate, even high-income countries may struggle to achieve adequate supply. even if improvements in baseline availability and preparedness happen with phenomenal efficiency, there will be transition periods and contexts where pain medications are, indeed, a scarce resource. how should pain medications be prioritised then and to whom ? in the who guide, palliative care is all encompassing. it is provided to patients regardless of triage status. however, when resources are scarce, it is inevitable to categorise patients and limit care to only some categories of these. when it comes to any form of life and death situation handled with limited resources, the primary dimension of categorisation is uncompromisingly clear: those who will survive and those who will not. using the principles provided by the guide, there is no clear answer whom to prioritise for palliative care. victims of emergencies with non-survivable diseases and injuries may take days to weeks to expire. is it right to continuously provide such patients with pain medication and comfort care while depriving of these patients who may survive? or, should we allocate all pain medications and personnel towards those who are likely to survive in order to increase their current and subsequent quality extended essay of life? the authors of the guide are adamant that palliative care is second only to life-sustaining measures. based on this logic, if human and material resources are scarce, those patients triaged as expectant will not be allocated palliative care resources in order to maximise the quality life years or utility for individuals for whom curative interventions are an option. this conclusion is contrary to the ethical and human imperative to provide care to all patients and practically leads us, full circle, to the point which spurred the movement for palliative care in humanitarian settings in the first place. the authors of the guide do, indeed, state often that society is morally obligated to provide palliative services to expectant patients. in chapter , they remark on the 'false dichotomy' between patients capable and not capable of being saved, insisting that both can receive active healthcare even in situations where resources are overwhelmed. this dichotomy only becomes false if one works under the assumption that resources, even when overwhelmed, are not scarce. such an assumption is not supported by historical and emerging covid-related evidence. we agree that there is a moral duty to provide palliative care to all patients, especially those for whom life-saving interventions are withheld due to scare resources. but the who guide lacks practical guidance on how to distribute this care, and what constitutes a minimum level of care where severe resource constraints exist. finally, the provision of palliative care in humanitarian crises adds a new dimension to the potential conflict between health worker safety and duty of care (non-abandonment). the case of memorial medical center in new orleans, louisiana, provides an example of how quickly and unexpectedly dilemmas around health worker safety and patient abandonment may arise. during hurricane katrina, memorial medical center encountered extreme difficulties in evacuating patients. there were too many people (patients and healthcare workers) and not enough helicopters to transport them. a decision on prioritisation had to be made. it was that the sickest patients and those with do not resuscitate orders were to be evacuated last. regardless of whether we agree with this particular decision or not, we must acknowledge that there are crisis situations when decisions about whom to save and whom to abandon need to be made in minutes, even split seconds, without opportunities for careful deliberation or consulting an ethics committee. in the current covid- pandemic, the dilemma around balancing healthcare worker safety against the duty of care in a palliative care context has reappeared in the care homes of several countries (eg, italy, spain, france, uk). staff in many care homes have not had sufficient personal protective equipment to allow them to care safely for patients dying with covid- . the challenge has been further exacerbated by understaffing due to carers becoming infected and going into quarantine, overlaid onto chronic staff shortages in the sector. [ ] [ ] [ ] as the current pandemic has grown, international aid workers operating in existing humanitarian crises too have been forced to make the impossible decision to stay and deliver much needed assistance to communities; or to leave their positions-and the communities they serve-to avoid confinement, the possibility of facing health risks away from their own families, or not being able to reach family members who may fall ill amidst a world in lockdown. either choice has led to distress for many humanitarian workers. even staying to fulfil the humanitarian imperative brings with it risks of 'doing harm' to communities by spreading the virus. how much should healthcare workers risk their own safety so as to leave no-one behind and/or accompany the dying? should they risk dying themselves in order to relocate to a safer place patients who are already dying or accompany infectious disease patients in their final hours? if some of those who are dying will be left behind or left alone, what is the right thing to do for them? how do the ethos and practice of palliative care interact with these questions? this brings us to the highly controversial topic of euthanasia, assisted suicide and assisted dying; and the standing, in humanitarian emergencies and crises, of the individuals and groups who may be contemplating such an end to their lives, whether legal or illegal in a particular jurisdiction. euthanasia translates, from greek, as 'good death'. euthanasia and the closely associated phenomena of assisted suicide and assisted dying have an ambiguous relationship to palliative care. in lay understandings, they are not only closely associated, but not infrequently misperceived as aspects of palliative care. at the same time, particularly in countries where euthanasia is illegal, they can be seen as antithetical. a study of declarations on euthanasia/assisted dying by inbadas et al found all declarations of palliative care organisations to take a position 'against' (with emphasis on clarifications that a patient's refusal or stopping of treatment, the withdrawal of futile treatment and palliative sedation are not forms of euthanasia). briefly, the argument is that people would not seek euthanasia if they are provided with good palliative care. most recently ( ), the iahpc has stated that no country should consider the legalisation of euthanasia or physician-assisted suicide until it ensures universal access to palliative care services and to appropriate medications, including opioids for pain and dyspnoea. conversations surrounding euthanasia can easily become convoluted. for the purposes of our discussion, we will only focus on how euthanasia interacts with the moral predicaments around resource limitations and patient prioritisation we have addressed so far. we will consider both voluntary and non-voluntary euthanasia, one of the most widespread typologies of euthanasia. voluntary euthanasia is 'where a person makes a conscious decision to die and asks for help to do so', while in non-voluntary euthanasia 'a person is unable to give their consent to treatment (eg, because they are in a coma) and another person takes the decision on their behalf, often because the ill person previously expressed a wish for their life to be ended in such circumstances'. we will also circumscribe the debate by highlighting that euthanasia is not permissible under international humanitarian law. this makes the debate legally theoretical, yet no less acute. in resource-scarce environments, is the right thing to do only to relieve pain? is there a role in such contexts for voluntary or non-voluntary euthanasia and/or assisted suicide to alleviate intractable pain, conserve pain medications and reduce the emotional burden on care providers and loved ones, while also respecting patient wishes? the who guide never explicitly uses the word euthanasia but does endorse providing medication to relieve severe, intractable pain, even if a side and unintentional effect of this may be to 'hasten death'. the intention behind such acts may be the only-and hidden-component which distinguishes them from some forms of euthanasia. the conversation about euthanasia thus hovers above the guide and seems to have deserved direct mention in it. one of the most controversial aspects of that conversation is that, in humanitarian contexts, arguments around the mercy in euthanasia are (perceived to be) entangled with considerations around resource limitations. as discussed, expectant patients may take weeks to days to expire. providing patients with a single, larger dose of barbiturates to enact a decision about euthanasia as opposed to administering small doses to achieve pain relief, over an extended period of time, can conserve medication. this medication can then be made available to others in need, who may not have been prioritised up to that point. while such dilemmas may be prime examples of 'hellish choices', it seems a given that some health professionals and some victims of disasters, no matter how few, have had to face such choices in all their brutality. yet even if a health professional has grappled with such dilemmas in their humanitarian work, as a rule, they would not have ever spoken about them. there are only a few countries (belgium, canada, luxembourg, the netherlands and switzerland, colombia) and a handful of us states and more recently australian states (california, colorado, montana, oregon, vermont and washington, new jersey, and hawaii in the usa; and victoria and western australia in australia) that have legalised euthanasia or assisted dying. as mentioned, euthanasia is not permissible under international humanitarian law. it could be argued that there are conversations to be had of whether the reference points relative to which societies decide on the acceptability and morality of euthanasia still hold fast in extreme humanitarian emergencies and crises, where suffering can take unimaginable proportions. these might also be contexts which demand of palliative care practitioners who are firmly opposed to euthanasia under normal life circumstances to further, or even reconsider, their argumentation. we do not argue for or against euthanasia. we argue that profound unintended negative consequences may follow if we downplay the likelihood that euthanasia-related concerns and dilemmas may arise in new ways for both humanitarians and palliative care practitioners once we begin to integrate consistently palliative care into the response to humanitarian emergencies and crises. these are likely to be further exacerbated for some expatriate humanitarian workers who, on one hand, may be influenced by vastly different beliefs about autonomy and choice in decisions about death and dying than those of local populations and, on the other, will often have no shared language to discuss or decline to discuss such topics. this brings us to our final critique. palliative care is not provided in a vacuum absent of social, economic, geographical, historical, political, cultural and similar interrelated forces, associated with gross inequalities and sources of conflict. if anything, the interplay of these forces is often the very cause of complex humanitarian crises. an article subsection only permits sketchy examples of how such factors may interact with the provision of palliative care in humanitarian emergencies and crises. but we hope that the ones we offer can illustrate how, if initiated incorrectly, palliative care services can inflame deep wounds, aggravating already perilous and precarious situations. to begin with issues of discrimination, there are at least two lines of argument suggesting that we need thoughtful plans to limit discrimination in palliative care in humanitarian contexts, as opposed to broad assertions that we are committed to it not happening. the first stems from discrimination in pre-existing humanitarian contexts; the second from discrimination in palliative care in 'normal life' and in the developed world. in turn, discrimination can take the form of both lack of provision of palliative care for traditionally discriminated groups or provision of palliative care instead of curative care when the latter is available but limited. some discrimination may even be (tacitly) endorsed, both in palliative care and humanitarian settings. such is the case of age. the impulse is often encapsulated in the 'fair innings' argument: older people have already lived enough on this planet; the younger ones have not had the chance. a -member us-based steering committee named the pediatric emergency mass critical care task force remarks (and endorses) that 'if several children can be saved with the resources used to treat one then it is ethically appropriate to favor several over one'. the omission of who the resources are to be taken from creates significant ambiguity, but it is unclear why, if the implied 'one' were not an adult, the statement would be worth making: prioritising the lives of several children over that of a single child would be a standard utilitarian choice, where no matter how excruciatingly difficult the sacrifice is and how many different solutions we attempt before resorting to it, the right thing to do would be hardly debatable, at least in the absence of further considerations. furthermore, the task force remarks on the 'unique attributes' of children, citing increased body surface area-tomass ratio, decreased subcutaneous tissue, decreased herd immunity and decreased cognitive development as reasons children may be categorised as a vulnerable population and, therefore, deserving of special priority. what these authors do not say is that the inclusion of such factors in a triage system will result in children always being prioritised for curative interventions over many adults in humanitarian crises. we have seen the operationalisation of the fair innings argument play out in practice in the current pandemic. the health system in italy, overwhelmed beyond capacity, 'invoked' the argument to justify prioritising younger adults for intensive care services over older, sicker adults. while we may promote cultures of non-discrimination-and we generally accept that we would not discriminate based on gender, age, ethnicity or disability-pandemic triage decisions are, by their nature, broadly discriminatory. even ethical decision-making frameworks currently being developed or used which invoke characteristics other than age, such as quality of life or maximising quantity of life years saved, frequently converge around the exclusion of older people. the empirical evidence on the deprioritisation of older people in humanitarian crises is compelling. during hurricane katrina in new orleans, louisiana, % of the deaths were of individuals over the age of , despite the latter accounting for only % of the overall population. in japan during the tsunami, % of the deaths were of individuals aged and above, despite their accounting for only % of the local population. the disproportionate deaths among older people need not be due to explicit discrimination in triage mechanisms. most humanitarian policies pay lip service to, or do not account at all for, the unique needs of this vulnerable population, for example, through policies addressing transportation to care facilities, nutrition and family separation. with racial discrimination, there is clear evidence of it occurring both in normal times within the developed world, and during times of humanitarian crisis. the mechanisms may be circuitous. during hurricane katrina, residents of new orleans were urged to evacuate by car before the hurricane made landfall. however, black americans, who, at the time, made up % of the population of the city, were over three times more likely not to have access to a vehicle, leaving them vulnerable to disproportionate morbidity and mortality. in the usa, people of african and latin descent are routinely undertreated extended essay for pain [ ] [ ] [ ] and their end-of-life wishes are assumed based on cultural generalisations. in the uk, a study revealed that black caribbeans were less likely to be aware of palliative care as a specialty than their white british counterparts -an example of how structural discrimination can impede equity even before a disaster strikes. there are pre-existing barriers when minority and vulnerable populations attempt to access either humanitarian support or palliative care as well as inequalities in their provision. at the intersection of the two, challenges are at best likely to be replicated and, potentially, significantly augmented. again, covid- has exemplified how a humanitarian crisis can expose pre-existing discrimination and structural racism. in the usa (as of april), black americans accounted for % of covid- hospitalisations and % of deaths (in / reporting states). in the uk, a report of the institute for fiscal studies (may ; the pandemic still ongoing) estimated that 'bangladeshi hospital fatalities are twice those of the white british group, pakistani deaths are . times as high and black african deaths . times as high'. such stark inequities have even prompted us ethicists, to ask if white americans should be deprioritised for critical care services to prevent the structural racism which grants them these life-saving privileges while depriving others. ethnic minority populations are disproportionately marginalised to low-income jobs where exposure to infectious diseases is more likely; and to poorer diets and poorly constructed built environments that are often risk factors for chronic illnesses such as diabetes, obesity and hypertension. in turn, emergent covid- triage and ethical guidelines for critical care services in scarce resource environments deprioritise on the basis of pre-existing conditions, [ ] [ ] [ ] thus further increasing the likelihood that racial and ethnic minorities suffer a higher death toll than the dominant group. if some of the above guidelines are also followed in their otherwise commendable emphasis on providing symptom control and palliative care to patients who have been deprioritised for critical care, then minorities may become overexposed to palliative care as a direct consequence of resource limitations. this would not be any 'fault' of palliative care and its practitioners. the deprioritisation decision too may be genuinely clinical, with no relationship to ethnicity at the point of patient presentation. but the legacy inequality and discrimination based on race and ethnicity will be underpinning the outcomes, and palliative care will be implicated in them. challenges such as the above are also likely to be amplified in middle-income and low-income countries. poor infrastructure, greater disease burden and fewer resources, reflecting the inequitable global distribution of wealth, contribute to higher mortality after an emergency. these also have an impact on the timeliness with which people can access services, which, in turn, has implications for the availability of treatments. if curative interventions are dispersed on a first-come, first-serve basis, once depleted, palliative care services may be the only intervention available. members of populations who faced barriers to arriving first for care may be relegated to palliative services not because of medical indication but, rather, because of social identity. palliative care may thus become a tool for masking and perpetuating inequity. how can we ensure that implicit biases or structural forces such as socioeconomic status do not impede appropriate care, whether curative or palliative, for minority or vulnerable populations in humanitarian contexts? we should also recognise that many middle-income and lowincome countries were once colonised by many of the same countries which provide aid today. in light of global colonialism, what does it look like for respondents from predominantly high-income countries to provide palliative care to persons from middle-income and low-income countries? we cannot assume we have earned the trust of these countries and communities and that all stakeholders will believe that endeavours of palliative care are pure hearted and not, indeed, extermination. during the ebola epidemic in sierra leone, for instance, local people were hiding corpses because they believed that the aid workers were selling the organs of their loved ones. there again, there were rumours that water, sanitation and hygiene teams were poisoning the water when they were chlorinating it; that drug companies were bringing in a disease for which they would then offer an expensive cure; that it was the nongovernmental organization (ngo) workers who were infected with and spreading ebola; and that, overall, 'the white man only turns up when people die, so there must be a link' (personal communication from i jacklin, ). more currently, public health experts speculate that the ebola outbreak in the democratic republic of congo, which is reported as the world's second-worst outbreak, is being fuelled by mistrust and 'community scepticism'. it has been reported that ebola treatment centres were attacked due to such mistrust and beliefs that the continued ebola outbreaks are profit driven (eg, white countries profiting from the illness and death of black bodies). in the current pandemic, un aid workers have been blamed for bringing covid- to south sudan after four of its staff tested positive, triggering xenophobia and the suspension of aid activities, and fuelling existing political suspicion over the presence of the un in the country as interfering with sovereignty. should we be developing policies and programmes to bolster trust in the context of palliative care or, even more generally, in crises with a high death toll from 'invisible' causes? closely intertwined with the above issues are the wide cultural differences in understandings of illness, death and dying which, in turn, shape local practices in caring for and comforting the sick or deceased person. how can we ensure that we learn our lessons, again from the ebola outbreak of - , when western values and practices of safety and public health clashed with local values and rituals around death and bereavement, each of them not only natural, but non-debatable, in the minds of those who held them? in many west african communities, local burials included a washing ceremony -a procedure that readily transmits ebola. who reported that % of the ebola cases in guinea during the outbreak were related to burial practices. precisely to minimise the risk of transmission, aid teams performed rapid burial ceremonies without familial notification. this bred contempt and mistrust. we are already witnessing the transformation of grieving and funeral practices across the world where covid- social distancing rules are being enforced. it is critical that we acknowledge local rituals around death and bereavement as covid- spreads and seek to build support among communities, religious leaders and funeral homes for adaptations to such rituals which are both compassionate and adhere to necessary infection control. finally (though only within an initial set of contextual considerations as opposed to a systematic list of these), a populationlevel view also begins to identify the contribution of local actors, such as health workers or family members, who are usually the first responders in a humanitarian emergency. local actors provide crucial care in the form of immediate and long-term practical and emotional support and simply sharing space with those who are suffering. it is nothing but a prejudice not to account for their extraordinary contributions to comforting the ill and dying and alleviating suffering. it is vital to consider how to integrate the resources of international humanitarian actors into existing care for the seriously ill and dying provided by local communities. as the globalisation of our world increases, we will be witnessing, experiencing and shaping more and more of its opportunities and abundance, of its challenges and tragedies together. this includes our humane and humanitarian response to alleviating the pain and suffering of the dying and terminally ill. who guidance on the integration of palliative care and symptom relief in humanitarian response is and will continue to be key to enabling what is a moral imperative, even if the covid- pandemic has been a too ferocious testing ground for its recent manual on the topic. it is of little value, apart from unpalatably righteous, to belabour the critical aspect of our argument. we hope that our paper will serve primarily as a source of ideas on improving successive documents on palliative care in humanitarian emergencies and crises. the core argument we have advanced is that applying a population-level ethics lens to the provision of palliative care in humanitarian settings brings up a whole host of ethical challenges that have been missed by an over-reliance on a predominantly clinical bioethics lens. we also suggest a range of considerations not captured by the utilitarian perspective-our default moral framework for when the good of the community needs to take priority over the good of the individual. the addition of a population-level ethics lens is in no way sufficient for illuminating all ethical dilemmas falling outside the visual field of clinical bioethics. population-level ethics is only one of many perspectives we need to incorporate in a robust and relevant ethical analysis of palliative care in humanitarian emergencies and crises. another type of analysis which should receive urgent priority is that informed by humanitarian ethics. the latter can offer unique insights about, for instance, the intersections between the personal and the political and between the intimate, the operational and the strategic. as slim asserts, 'it is in the realm of politics that humanitarian ethics finds its natural habitat and not simply the realm of medicine, nutrition, sanitation, economics or social work that make up the various fields of its practice. doing humanitarian work at scale is doing politics'. humanitarian ethics is, crucially, multilevel ethics: the intimate, where humanitarian workers such as doctors, engineers or social workers support individuals, and families and communities, acting in an individuals' best interests to alleviate suffering; the operational, where humanitarian managers need to make ethical decisions about areas of operation to support populations within camps, districts and regions (this level is likely to involve questions about resource allocation and political questions concerning cooperation with governments, other ngos and sometimes armed groups); and the strategic, where leaders of humanitarian organisations must make global choices around funding, geographical and sectoral priorities and political partnerships, concerned with institutional interests and goals. it is easy to see how neither clinical bioethics, nor population-level ethics can offer sufficient insights into the operational and strategic levels of humanitarian ethics, both for the humanitarian health response in general and for strands of it addressing the needs of the seriously ill and the dying in particular. the perspectives of disciplines such as anthropology, crosscultural psychology, legal studies, sociology, history, social geography, colonial and postcolonial studies, and political science can further advance the relevant ethical debate. for instance, ethical issues around opioid dependency, and the legal regimes associated with them, are a widely debated problem but one which we deprioritised so as to bring out more acute blind spots. additional ethical issues can be identified, of course, by practising humanitarians and the recipients of their support. there must also be oft-forgotten perspectives which too can be exceptionally illuminating, such as those of interpreters and drivers, the often invisible intermediaries in humanitarian settings. beyond upholding the importance of a much richer ethical debate, we have also been arguing, be it largely indirectly, for a greater honesty and humility in it. it is important to have documents which outline and promote a positive vision. but when that vision is too distant from current and contextually diverse realities, such documents become irrelevant, even deserving of cynicism. it is particularly incomprehensible when this happens with regard to palliative and end-of-life care-a field defined by its ability to face some of the darkest and most frightening aspects of life and still preserve our hope and humanity. we hope this paper can stir a debate among a broad variety of stakeholders, for the benefit of all whom we cannot save during humanitarian crises and who are experiencing grave suffering, whether physical, emotional, social or spiritual. and while only a small proportion of us will work firsthand to alleviate such suffering, most of us are its (distant) observers and, without exception, its potential victims. we cannot be looking away. twitter keona jeane wynne @keonawynne contributors all authors contributed equally to this work. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. disclaimer the views expressed in this paper are rc's and mp's views as an academic researchers and not a formal position of palchase. competing interests mp reports that she is a steering group member of palliative care in humanitarian aid situations and emergencies network. rc reports that she is a member of the palliative care in humanitarian aid situations and emergencies network. patient consent for publication not required. provenance and peer review not commissioned; externally peer reviewed. this 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program directors covid- -ethical issues. a guidance note palliative care considerations in mass casualty events with scarce resources the elephant in the room: collaboration and competition among relief organizations during high-profile disasters families in liberia are paying bribes for false certificates over ebola deaths how the fight against ebola tested a culture's traditions tackling congo's ebola outbreak "more than a public health response. new humanit the new humanitarian | what's behind south sudan's coronavirus inspired unbacklash the impact of traditional and religious practices on the spread of ebola in west africa: time for a strategic shift a good death" during the covid- pandemic in the uk: a report on key findings and recommendations coronavirus is changing how american muslims hold funerals | middle east eye humanitarian ethics : a guide to the morality of aid in war and disaster key: cord- -hjzlj k authors: mick, paul; murphy, russell title: aerosol-generating otolaryngology procedures and the need for enhanced ppe during the covid- pandemic: a literature review date: - - journal: j otolaryngol head neck surg doi: . /s - - - sha: doc_id: cord_uid: hjzlj k background: adequate personal protective equipment is needed to reduce the rate of transmission of covid- to health care workers. otolaryngology groups are recommending a higher level of personal protective equipment for aerosol-generating procedures than public health agencies. the objective of the review was to provide evidence that a.) demonstrates which otolaryngology procedures are aerosol-generating, and that b.) clarifies whether the higher level of ppe advocated by otolaryngology groups is justified. main body: health care workers in china who performed tracheotomy during the sars-cov- epidemic had . times greater odds of contracting the virus than controls who did not perform tracheotomy ( % ci . – . ). no other studies provide direct epidemiological evidence of increased aerosolized transmission of viruses during otolaryngology procedures. experimental evidence has shown that electrocautery, advanced energy devices, open suctioning, and drilling can create aerosolized biological particles. the viral load of covid- is highest in the upper aerodigestive tract, increasing the likelihood that aerosols generated during procedures of the upper aerodigestive tract of infected patients would carry viral material. cough and normal breathing create aerosols which may increase the risk of transmission during outpatient procedures. a significant proportion of individuals infected with covid- may not have symptoms, raising the likelihood of transmission of the disease to inadequately protected health care workers from patients who do not have probable or confirmed infection. powered air purifying respirators, if used properly, provide a greater level of filtration than n masks and thus may reduce the risk of transmission. conclusion: direct and indirect evidence suggests that a large number of otolaryngology-head and neck surgery procedures are aerosol generating. otolaryngologists are likely at high risk of contracting covid- during aerosol generating procedures because they are likely exposed to high viral loads in patients infected with the virus. based on the precautionary principle, even though the evidence is not definitive, adopting enhanced personal protective equipment protocols is reasonable based on the evidence. further research is needed to clarify the risk associated with performing various procedures during the covid- pandemic, and the degree to which various personal protective equipment reduces the risk. during the coronavirus disease (covid- ) pandemic, personal protective equipment (ppe) worn by health care workers is critical for reducing transmission of the infection in health care settings, particularly when aerosol-generating medical procedures (agmp) are being performed. an aerosol is a suspension of fine solid particles or liquid droplets in air or another gas. within an aerosol, viral droplet nuclei can travel long distances and remain in the air for long periods of time. aerosols are not as effectively filtered by surgical masks, and can be breathed directly into the lungs. for transmission to occur, it is not enough for viral material to exist in droplet nuclei; the virus must remain viable. whether or not covid- remains viable in aerosols (and for how long) is still being investigated, but the balance of evidence indicates that betacoronaviradae such as the sars coronavirus (sars-cov- ) are viable in aerosols [ ] . many otolaryngology procedures are thought to be aerosolgenerating [ ] . when healthcare workers are at risk of transmission of infection from aerosols, "airborne" (rather than droplet) precautions are required [ ] . otolaryngologists who are susceptible to being infected with covid- and who are working in close proximity to infected tissues for lengthy periods may be exposed to large infectious doses. covid- infects the upper aerodigestive tract with the highest viral loads occurring in the nasal cavities [ ] . the surgeon's nose, throat, and conjunctiva (all potential routes of transmission) [ , ] are typically within - cm of the patient's upper respiratory mucosa. during agmp, as a surgeon gets closer to the source of the aerosol, particle density increases exponentially according to principles of diffusion [ ] . the association between infectious dose and disease severity has not yet been determined. analogous novel viral respiratory viruses, however, may provide a degree of evidence. the basic reproductive numbers (the expected number of cases directly generated by one individual in a population where all individuals are susceptible) for sars-cov- and covid- appear to be similar and thus comparisons are reasonable [ , ] . in animal studies, increasing the initial exposure to sars-cov- increased the risk that mice developed the infection [ ] . greater initial exposures to sars-cov- [ ] , mers coronavirus [ ] and influenza [ ] resulted in more severe disease. in at least one recent study, a higher concentration of covid- in the nasal passages (i.e., higher viral load) was associated with increased risk of more severe disease and death [ ] . viral load, however, is measured after the onset of infection and thus is not a proxy for infective dose. during the pandemic, health care agencies such as the world health organization, u.s. centers for disease control and the public health agency of canada [ , , ] are responsible for defining agmp and rationing ppe when demand is greater than supply. the lists of agmp often do not specifically include otolaryngology procedures. national otolaryngology organizations and other ent groups [ ] have published otolaryngology-specific agmp lists and ppe guidelines that call for a greater levels of protection than the public health agencies. for example, givi et al and the canadian society of otolaryngology-head and neck surgery [ ] call for airborne precautions when performing agmp on patients for whom the index of suspicion for covid- infection is not high, whereas the world health organization, the u.s. centers for disease control, and the public health agency of canada do not [ , , ] . givi et al also suggest that health care workers use powered air purifying respirators (paprs) when available for agmp performed on patients with probable or confirmed covid- , in contrast to public health agencies that are either silent on the issue or suggest paprs are not needed [ ] . we are members of the division of otolaryngology in saskatoon, saskatchewan. we were invited by the local health authority to provide evidence that a.) demonstrates which otolaryngology procedures are aerosolgenerating, and that b.) clarifies whether the higher level of ppe advocated by otolaryngology groups is justified. the following serves as a summary of our submission. part : aerosol-generating otolaryngology procedures is covid- transmitted via aerosols? respiratory aerosols typically consist of droplet nuclei less than μm in size [ ] . droplets fall to the ground at rates inversely proportional to their size. a μm diameter particle settles in . min, compared to . h for a μm diameter particle, and h for a μm particle [ ] . thus, unless rooms are well ventilated, aerosolized droplets can become more concentrated over time. for an infection to be transmitted via aerosol, the organism must be able to survive within the droplet nuclei until it is deposited onto the mucous membrane of a susceptible individual either via inhalation or direct contact. the world health organization has cautioned that more studies are needed to confirm if covid- is transmitted via aerosols [ ] , however an april , report from the u.s. national academies of science, engineering and medicine suggests it is likely [ ] . the letter cites studies in which covid- rna was detected in air samples in hospital rooms of patients with covid- [ ] . a widely cited experimental study indicates that covid- can remain viable in aerosols for hours [ ] , but has been criticized since the methods used to aerosol the virus in the experiment are not reflective of agmp or natural cough [ ] . a case report of a trans-nasal pituitary adenoma excision performed in china before widespread introduction of strict ppe provides anecdotal evidence of aerosolized transmission of covid- . during the case, fourteen chinese health care workers were reportedly infected by the patient (who was mildly symptomatic pre-operatively), who was later confirmed to have covid- . transmission occurred to workers who were both inside and outside the operating room [ ] . during the sars-cov- epidemic, the largest nosocomial outbreak in hong kong occurred with a clear spatial pattern of infection that matched ventilatory patterns of the hospital floor, suggesting aerosolized transmission was likely [ ] . a similar study showed that the pattern of spread of a large community outbreak of sars-cov- matched the ventilatory pathways from the apartment of the index case [ ] . research about agmp has arisen from and been motivated by the need to protect health care workers during previous pandemics. cohort and case-control studies comparing the rates of transmission from patients to health care workers who perform certain procedures versus health care workers who do not provide direct evidence of the risk conferred by the procedures. experiments demonstrating that various procedures generate aerosols provide more limited evidence since they do not prove that transmission occurs via the airborne route. after the aids epidemic of the s there was concern regarding the transmission of blood-borne viral illnesses during surgery. experiments showed that electrocautery, bone drilling, ultrasonically activated (harmonic) devices, and suction irrigation create aerosolized blood droplets and tissue particles [ ] [ ] [ ] [ ] . there is no epidemiological evidence, however, that the human immunodeficiency virus can be transmitted via aerosolized blood droplet nuclei [ ] . experiments have also shown that intranasal and temporal bone drilling aerosolizes bone, blood and mucosa [ , , ] . workman et al applied fluorescein inside the nasal cavity of cadaveric specimens, performed various surgical procedures, and measured aerosol spread outside of the nostrils using a blue-light filter and digital image processing. intranasal drilling but not cold instrumentation or microdebriding produced fluorescein aerosols that could be detected up to cm from the nostrils [ ] . during temporal bone drilling the spread of particles might be greater since the walls of the nasal cavity likely prevent the spread of some material. it is not known if the respiratory mucosa lining the middle ear and mastoid air cell system is involved in covid- , but because the rest of the airway is involved, it appears likely that the lining of the eustachian tube, middle ear, and mastoid air cell system are also contaminated [ , ] . .for these reasons, the use of use of high speed drills during mastoidectomy should be considered an agmp during covid- . during the sars-cov- epidemic, it was initially thought that transmission occurred primarily via contact or large respiratory droplets. it was observed, however, that transmission to health care workers occurred despite the use of contact and droplet precautions, particularly during procedures suspected to be aerosolgenerating such as endotracheal intubation [ , ] . a meta-analysis of observational studies evaluating the risk of transmission of sars-cov- during the epidemic showed that health care workers performing endotracheal intubation, non-invasive ventilation, tracheotomy and manual ventilation before intubation were significantly more likely than health care workers not involved in these procedures to contract the disease [ ] . only one case-control study of front-line health care workers caring for sars-cov- patients in china contributed to the "meta-analysis" of tracheotomy [ ] . in the univariate analysis, / cases (who had igg against sars-cov- ) versus / controls (who did not have igg against sars-cov- ) had performed tracheotomies during the epidemic (odds ratio . , % ci . , . ). the odds ratio for bronchoscopy, on the other hand, did not reach significance (pooled or . , % ci . , . ). many public health agencies and professional organizations [ ] , however, list bronchoscopy as an aerosol generating procedure. the world health organization appears to classify bronchoscopy [ ] as an agmp based on a study comparing the rate of tuberculin skin test conversion among pulmonology and infectious diseases fellows graduating in during a resurgence of tuberculosis in the united states. seven of ( %) pulmonology fellows versus one of ( . %) infectious diseases fellows reported having converted tuberculin skin tests during their fellowships [ ] . it was not clear that the pulmonology fellows were infected as a result of performing bronchoscopies. a study during the h n influenza outbreak measured the amount of viral rna in the air in the vicinity of h n positive patients undergoing bronchoscopy and other procedures, compared to controls. the concentration of viral rna was not significantly increased during bronchoscopy or any other procedure studied. the authors wrote that their study may have been underpowered to detect small differences in aerosol concentrations [ ] . if bronchoscopy is aerosol-generating, it may be due to the suctioning usually involved with the procedure. air currents moving across the surface of a film of liquid generate droplets at the air-liquid interface, with the size of the droplets inversely proportional to the velocity of the air [ ] . it is for this reason that any procedure that involve open suctioning of the airway is usually classified as aerosol-generating. there do not appear to be any studies that directly assess whether diagnostic nasopharyngoscopy produces aerosols in patients infected with respiratory viruses, and/or if it is associated with increased risk of airborne transmission of respiratory viruses to healthcare workers. workman et al performed an experiment in which they pushed an atomizer device from the cranium of a cadaver through the cribriform plate and into the nasal cavity, plunged the syringe "at maximal pressure" to inject aerosolized fluorescein into the nasal cavity, then performed intra-nasal endoscopy and measured the spread of fluorescein out the nostrils. various masks that were modified to allow passage of the endoscope were placed on the cadaver head in front of the nostrils. it is not known whether their methods accurately mimic the situation in patients with covid- . they did find, however, that the masks reduced the spread of fluorescein outside the nostris [ ] . despite the lack of evidence, in the covid- era diagnostic endoscopy of the upper airways is often listed as an agmp by health care agencies, likely because of its perceived similarities to bronchoscopy and because the endoscope travels through tissues with high covid- viral loads [ , ] . in contrast to bronchoscopy, however, many endoscopic procedures of the upper aerodigestive tract do not require suctioning. further evidence is needed to understand the degree to which endoscopy of the upper aerodigestive tract generates aerosols. generation of aerosols during cough, pursed lip breathing and normal breathing: implications for outpatient procedures most ent outpatient procedures induce coughing due to deep instrumentation and/or excessive mucous or blood that triggers the cough reflex. the jet of droplets and aerosols expelled by a cough can hit nearby health care workers at high volume and velocity, and at close range. the frequency of cough is higher in a patient infected with covid- , since it is a symptom of the infection [ ] . the world health organization considers cough to be aerosol-generating [ ] , a position that is supported by a number of studies [ ] [ ] [ ] [ ] [ ] [ ] . the average distribution of droplet sizes expelled during cough ranges on average between . - . μm, with multimodal peaks at , and μm. larger droplets may partially evaporate during the jet expulsion from the mouth to produce smaller droplet nuclei [ ] . aerosols are also generated by "pursed lip" breathing methods, often adopted by patients who have epistaxis to avoid aspirating blood trickling posteriorly and into the throat [ ] . aerosols can be produced by normal breathing as air passes over respiratory mucosa [ ] [ ] [ ] , through the reopening of closed small airways to form small airborne droplets [ ] , and/or through fluid film rupture in the bronchioles [ ] . during normal breathing, the lungs filter out most larger droplets from being exhaled [ ] . as might be expected, coughing produces more aerosolized droplets than normal breathing or talking [ ] . breathing rate and age are both positively correlated with breath aerosol concentration, but do not completely explain the variability observed between individuals [ ] . head and neck physical examinations and the collection of nasopharyngeal swab samples are not typically classified as agmp [ ] . the fact that aerosols are produced during normal breathing combined with the close proximity required to perform these procedures do, however, provide support for recommendations from otolaryngology groups that airborne precautions should be taken by health care workers performing head and neck examinations in patients who have suspected or known covid- [ ] . part : evidence clarifying if enhanced ppe are needed for otolaryngology agmp givi et al and the canadian society of otolaryngology-head and neck surgery suggest adhering to airborne precautions when performing agmp on patients whose covid- status is unknown or who have low risk of infection during the pandemic [ , ] . they also recommend paprs (if available) to perform agmp on patients with probable or confirmed covid- [ , ] . the world health organization [ ] , cdc [ ] and public health agency of canada [ ] do not make these recommendations. occupational health professionals are often tasked with determining the type of ppe needed in novel circumstances arising in various industries. the cdc through the national institute for occupational safety and health (niosh) [ ] and the canadian center for occupational safety and health [ ] recommend "control banding" as a qualitative or semi-qualitative technique used to guide the implementation of workplace control measures. in control banding assessments, the potential for harm is determined by .) the consequences of exposure; .) the concentration of toxin; and .) the risk of exposure. operations that expose workers to a greater potential for harm demand more stringent control measures. the consequences of covid- infection to individuals are well described elsewhere [ ] but range from mild illness to death. if health care workers become sick they can pass the infection to others, propagating the pandemic, and are no longer available to assist on the front lines. the increased risk of exposure to high concentrations of aerosols during otolaryngology agmp has already been discussed. thus, the following section focuses on the third element, the risk of exposure to covid- , and the likelihood that the different ppe recommended by the different groups alters the risk. the risk of exposure to covid- when a patient's covid- status is unknown a significant proportion of individuals infected with covid- are either pre-symptomatic (they have not developed symptoms yet) or asymptomatic (they never develop symptoms). the mean incubation of covid- period is - days, with a range of - days [ ] . a well-known study of passengers on the quarantined diamond princess cruise ship showed that % of persons who tested positive for covid- had no symptoms at the time of testing [ ] . on march , , the director of the u.s. centers for disease control (cdc) stated that the percentage of people in the general population who have covid- but do not have symptoms is % [ ] . this estimate ranges from . % in china [ ] to % in iceland, where a very high proportion of the population ( %) has been tested for covid- and thus the results may be more reflective of reality [ ] . pre-symptomatic carriers can transmit disease. on april , the cdc reported the results of an investigation of all cases of covid- reported in singapore between january and march . seven clusters of cases were identified in which pre-symptomatic transmission was the most likely cause of secondary cases [ ] . it is estimated that % of transmission could occur before the first symptoms [ ] . the true number of cases of covid- in the population is unknown but is assuredly much higher than the number of cases confirmed by testing and reported to government agencies due to limitations in population sampling and test sensitivity [ ] . it is therefore likely that a significant proportion of patients presenting to the health care system for various reasons but who do not complain of symptoms of covid- will be infected with the virus and can transmit it to health care workers for many months to come. the sensitivity and specificity of commonly performed covid- diagnostic tests has not been definitively determined in part because a safe "gold standard" comparator has yet to be developed. variability in sampling due to technical difficulties swabbing the nasopharynx or because of changes in the viral load throughout the course of illness may affect the sensitivity of the test. a negative result thus does not necessarily rule out infection. if the test is positive, it is likely correct, although it is possible that though cross-contamination from other patients or lab workers could result in false positive results [ ] . the positive-and negative-predictive values of the test depend in part on the local true prevalence of covid- . for the reasons stated above, recommendations for airborne precautions for agmp performed on patients whose covid- status is unknown during the pandemic appear to be reasonable according to the precautionary principle [ ] . it is not clear when such precautions should be rescinded. published epidemiological projections suggest that similar to previous pandemics, even after the current wave of new cases subsides, outbreaks will recur throughout the world over at least the next year until herd immunity and/or an effective vaccination program is established [ ] . the risk of exposure of covid- using powered airpurifying respirators, reusable elastomeric respirators and filtering facepiece respirators (n masks) powered air-purifying respirators (paprs), reusable elastomeric respirators and filtering facepiece respirators (e.g., n masks) represent different methods of filtering out aerosols in the air. a papr, which costs about usd , contains a battery-powered high-efficiency particulate air filter that delivers clean air into a hood or a full face mask, and blows off exhaled air. the hood is either hard and tight-fitting or loose. the risk of leakage with paprs is negligible and, unlike reusable elastomeric respirators and n masks, there is no need for a fit test or additional eye protection since the head is completely enclosed within the system [ ] . this feature of the papr benefits individuals who fail fit tests and those whose religious beliefs prevent them from shaving. decontamination protocols for paprs must be in place and adhered to meticulously before they are re-used [ ] . resuable elastomeric respirators, which typically cost <usd , are used more commonly in heavy industry than health care. such devices are made to meet national institute for occupational safety and health (niosh) standards, and are defined by the ability of the device to filter out oil or non-oil particulate. they may either cover the lower half of the face (and require additional eye protection) or cover the entire face. respirators are classified according to their particulate filtration efficiency; both reusable elastomeric respirators and filtering facepiece respirators come in p ( . % filtration efficiency) and n ( % filtration efficiency) varieties [ ] . the familiar n mask costs usd . and can thus be more widely distributed during a pandemic. no studies exist that directly compare the different respirators' abilities to prevent transmission of viral illness in the health care setting. such studies would need to incorporate doffing and reprocessing procedures in the experimental design, since there is high risk of transmission if doffing is performed incorrectly, and the risk may be modified by the type of ppe used [ ] . .experimental studies in the occupational health literature have been performed that compare how well different respirators filter aerosols (typically sodium chloride aerosols) in simulated industrial environments. the protection factor is a measure of the ratio of airborne contaminant inside and outside the respirator. the u.s. occupational health and safety administration reports that the assigned protection factor (i.e., the workplace level of respiratory protection that a respirator is expected to provide to employees in the context of a "continuing, effective respiratory protection program") for paprs ranges between and , , versus for filtering facepiece respirators, for half mask elastomeric respirators, and for full facepiece elastomeric respirators [ ] . other reports similarly demonstrate the superior performance of paprs or elastomeric respirators in simulated workplace environments compared to n filtering facepiece respirators [ , ] . a major risk with filtering facepiece respirators and reusable elastomeric respirators is that the air tight seal can leak during a procedure, compromising their performance. in a study of subjects each tested on six different n masks, thermal imaging showed that leakage (mainly in the nasal and malar region) occurred in all failed leak tests [ ] and the majority ( of ) passed fit tests [ ] . the risk of leakage would be expected to increase with the length of time the n mask is worn, for example during long otolaryngology cases. there is concern that the unfiltered exhaust from paprs may increase the risk of transmission of virus particles to patients from users who are unknowingly infected with covid- , but this risk would likely be diminished if papr users wore surgical masks [ ] . paprs may be cumbersome to use, may fog up, and prevent the use of headlights, but these concerns are also true of masks, face shields and goggles. the balance of evidence suggests that paprs and full facepiece elastomeric respirators, when properly used, doffed and reprocessed, would be expected to reduce the risk of transmission of infection and/or severity of illness by reducing exposure to covid- during high risk otolaryngology cases, compared to n masks. costeffectiveness studies comparing different respirator types have not been performed but it may be feasible for hospitals to acquire a limited number of suits for use during high risk procedures. a - survey across six american states that included hospitals indicated that % of the hospitals had paprs available [ ] . the prevalence of paprs in canadian hospitals is unknown. as initial outbreaks of covid- diminish there is an opportunity for hospitals to acquire paprs and develop protocols for their use in preparation for future covid- cases and outbreaks. given the shortages of disposable n filtering facepiece respirators worldwide, there has been emphasis on their reuse. for example, givi et al state that it may be appropriate to reuse n masks after agmps performed on patients at low risk of having covid- [ ] . experimental models show that virus survival on n masks depends on time elapsed and relative humidity [ ] . sars-cov- can survive for up to days on medical equipment in low temperature and low humidity environments [ ] . there has been no published research on experiments involving covid- . a variety of decontamination methods have been proposed, from using heat and steam, hydrogen peroxide vapor, uv light, and letting the mask sit for days before repeat usage [ ] [ ] [ ] . the use of ultraviolet light (uv-c) has been proposed owing to its ability to penetrate the materials found in n masks [ ] . using a surrogate virus, fisher and shaffer described that a minimum dose of j m − of uv-c is required to cause a log reduction in a surrogate virus [ ] . vaporized hydrogen peroxide has also been suggested as method useful for decontaminating materials, and has been demonstrated to reduce infectious titers of mammalian viruses to less than ten % tissue culture infective doses (tcid ) [ ] . the cdc has provided statement that decontamination with either uvc, vaporized hydrogen peroxide, or moist heat could be considered by health care institutions in an emergency [ ] . of the myriad of different procedures performed by otolaryngologists, only tracheotomy has specifically been found to pose an increased risk of airborne viral transmission to health care workers, in a study examining exposure to agmp performed on patients with sars-cov- [ ] . a large amount of indirect evidence, however, demonstrates that most surgical procedures of the upper aerodigestive tract create aerosolized biological particles through the use of suction, cautery, and other powered instrumentation. in patients infected with covid- , aerosolized particles would likely contain viral material because of high viral loads in the upper aerodigestive tract. cough, pursed lip-and natural breathing also produce aerosols. the close proximity of a physician performing outpatient ent procedures to an infected patient's mouth and nose adds further hazard. emerging evidence suggests that covid- is viable in aerosolized droplet nuclei and that a larger infective dose (which may result from prolonged exposures during long procedures) may increase the severity of disease. at any given time, a significant proportion of patients infected with covid- will not have symptoms. negative covid- test results may not be accurate. travel history will no longer be an important predictor of disease as border restrictions severely reduce the frequency of travel. it is thus reasonable, based on the precautionary principle, for health care workers performing agmp during the pandemic to observe airborne precautions regardless of whether a patient is known to have covid- or not. otolaryngology groups have advocated for the use of respirators with greater filtration capabilities than n masks, when available. experimental studies conclude that paprs and reusable elastomeric respirators have greater filtration capabilities when used, doffed and reprocessed properly. studies have not been performed that compare rates of transmission and costeffectiveness between different types of respirators in the real-world circumstance of a pandemic. paprs are significantly more expensive than other types of respirators but the investment appears to be reasonable for lengthy high risk procedures. local institutional recommendations and regionspecific epidemic characteristics must be taken into account when determining ppe use. otolaryngology-head and neck surgery is a relatively small specialty and institutional pandemic planning committees may be unaware of the level of ppe required for otolaryngology procedures. otolaryngologists should participate in or communicate with ppe planning committees so that their viewpoints are reflected in institutional protocols. regional epidemic characteristics (e.g., the prevalence of cases and trend of the epidemic curve) should also be considered when determining the level of ppe required, especially when a patient's covid- status is unknown. patients who do not have a diagnosis of covid- are obviously more likely to be asymptomatic or pre-symptomatic carriers if they live in regions where the prevalence is high. the reported prevalence, however, may underestimate the true value especially in jurisdictions where the rate of screening testing is low. furthermore, even if the epidemic curve shows signs of flattening or diminishing, recurrent outbreaks may occur suddenly and without warning, especially if physical distancing and/or other public health measures are not being effectively followed [ ] . the most cautious approach, if possible, would therefore be to adhere to a higher standard of ppe until the pandemic is over. there is an opportunity to perform research to quantify the risk of covid- transmission from patients to health care workers performing aerosol-generating otolaryngology procedures during the covid- pandemic. the most important studies would be cohort studies that aim to estimate the risk of developing covid- from performing otolaryngology agmps, and 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nanoparticles under simulated workplace activities infrared imaging for leak detection of n filtering facepiece respirators: a pilot study practical recommendations for critical care and anesthesiology teams caring for novel coronavirus ( -ncov) patients tt -directives concrètes à l'intention des équipes de soins intensifs et d'anesthésiologie prenant soin de patients atteints du corona hospital respiratory protection practices in u.s. states: a public health evaluation study survival of a surrogate virus on n respirator material coronavirus survival on healthcare personal protective equipment hydrogen peroxide vapor sterilization of n respirators for reuse. medrxiv rapid evidence summary on sars-cov- survivorship and disinfection, and a reusable ppe protocol using a double-hit process. medrxiv n respiratory masks for covid- : a review of the literature to inform local responses to global shortages comparison of uv c light and chemicals for disinfection of surfaces in hospital isolation units a method to determine the available uv-c dose for the decontamination of filtering facepiece respirators efficacy of vaporized hydrogen peroxide against exotic animal viruses decontamination and reuse of filtering facepiece respirators covid- : where we are. considerations for next steps springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations not applicable. authors' contributions pm conceived the review, conducted a literature review, wrote and edited the manuscript. rm conceived the review, conducted a literature review, wrote and edited the manuscript. the author(s) read and approved the final manuscript. none.availability of data and materials not applicable.ethics approval and consent to participate not applicable. not applicable. the authors declare that they have no competing interests. received: april accepted: april key: cord- - fmd e authors: burkle, frederick m. title: political intrusions into the international health regulations treaty and its impact on management of rapidly emerging zoonotic pandemics: what history tells us date: - - journal: prehospital and disaster medicine doi: . /s x sha: doc_id: cord_uid: fmd e for a large number of health care providers world-wide, the coronavirus disease (covid- ) pandemic is their first experience in population-based care. in past decades, lower population densities, infectious disease outbreaks, epidemics, and pandemics were rare and driven almost exclusively by natural disasters, predatory animals, and war. in the early s, sir william osler first advanced the knowledge of zoonotic diseases that are spread from reservoir animals to human animals. once rare, they now make up % or more of new diseases. globally, zoonotic spread occurs for many reasons. because the human population has grown in numbers and density, the spread of these diseases accelerated though rapid unsustainable urbanization, biodiversity loss, and climate change. furthermore, they are exacerbated by an increasing number of vulnerable populations suffering from chronic deficiencies in food, water, and energy. the world health organization (who) and its international health regulation (ihr) treaty, organized to manage population-based diseases such as influenza, severe acute respiratory syndrome (sars), h n , middle east respiratory syndrome (mers), hiv, and ebola, have failed to meet population-based expectations. in part, this is due to influence from powerful political donors, which has become most evident in the current covid- pandemic. the global community can no longer tolerate an ineffectual and passive international response system, nor tolerate the self-serving political interference that authoritarian regimes and others have exercised over the who. in a highly integrated globalized world, both the who with its ihr treaty have the potential to become one of the most effective mechanisms for crisis response and risk reduction world-wide. practitioners and health decision-makers must break their silence and advocate for a stronger treaty, a return of the who’s singular global authority, and support highly coordinated population-based management. as osler recognized, his concept of “one medicine, one health” defines what global public health is today. whereas the ihrs provide a vital governing framework to limit the spread of disease, serious deficiencies, omissions, gaps, and political resistance began to occur. gostin and katz described wide-spread noncompliance to the ihr detailing multiple needed textual and operational reforms, emphasizing that who and the ihr "erred at multiple levels during the ebola epidemic" and who failed "to mobilize adequate fiscal and human resources until the epidemic was spinning out of control." in , after the ebola epidemic, i wrote "the intent of the legally binding treaty to improve the capacity of all countries to detect, assess, notify, and respond to public health threats has shamefully lapsed," and that global health security demanded both a stronger who and a stronger ihr treaty. the who, sponsored by the un, currently has two primary sources of revenue: assessed contributions expected to be paid by member-state governments, income, and population; and voluntary contributions provided by member-states and contributions from private organizations and individuals, the latter of which opens the who up to being influenced by the highest bidder. the who must exist solely as a treaty-based organization sanctioned by the un and all its members, not dependent on outside financial assistance to do its work. health care experts, as sir william osler described, must be in charge of all health decisions, monitoring, response, and operational research. they neither abdicate any responsibilities to individual nation-states nor be beholden to them for support. the bottom line is that the global community can no longer tolerate an ineffectual and passive international response system, nor tolerate the self-serving political interference that authoritarian regimes, nationalism, and populism demand. this remains a highly integrated globalized world when it comes to public health protections. the current coronavirus disease (covid- ) pandemic experience leads to only one solution: the who must be restructured from top to bottom to remove individual countries from health and public health assessment, decisions, and management. without political pressure, who and the ihr treaty have the potential to become the most effective partners in crisis response and risk reduction. practitioners and health decisionmakers world-wide must break their silence and advocate for a stronger treaty and a return of who's singular authority. the majority of health care providers world-wide practice oneon-one care with their patients. population-based care has not been emphasized in their training. a major deficiency in global health and the entire ihr process has been the failure to recognize the importance of zoonotic diseases-those diseases that can be passed from animals to humans. world-wide, zoonotic diseases represent % of all diseases and an alarming % of new diseases. second only to war, zoonotic epidemics have killed more humans than any other disease. today, it is known that climate change, overuse of antibiotics, and more intensified farming are thought to also be increasing the rate of zoonotic diseases globally. my first experience in zoonotic disease was in during the vietnam war. that year, south vietnam witnessed the largest bubonic plague epidemic of the th century. indeed, that outbreak temporarily paused the war on both sides of the conflict and emptied small villages and larger city streets. it prompted me to educate myself on the massive influence zoonotic diseases have on the environment and public health. for many of my generation of physicians, sir william osler remains a crucial role model, famous for his writings and for taking the teaching of medicine out of the classroom to the bedside. few know that he taught at both medical and veterinarian colleges, advancing the basic knowledge of veterinary pathology and zoonotic diseases, or those that commonly spread from non-human animals to humans. osler's work advanced the understanding of today's infectious disease outbreaks, epidemics, and pandemics. it was a veterinarian, calvin schwabe, schooled under osler's teachings and now recognized as the father of veterinary epidemiology, who first coined the term "one medicine" as the science of health and disease in which "differences between humans and animals are not considered." schwabe pointed out that most infectious diseases of humans have an animal origin that incorporated the "inclusion of environmental health, as opposed to simply medical treatment" into the crucial management of major infectious diseases such as sars, h n , and today's covid- . in his book aequanimitus, osler emphasized that medicine is the "only world-wide profession following the same methods, actuating the same ambitions, and pursuing the same ends." he emphasized that this "homogeneity" or "solidarity" which physicians world-wide are witnessing today with the covid- pandemic is a quality "not shared by law" or politics, that "allows physicians to practice the same art amid the same surroundings in every country on earth." this unity of effort is not seen in other professions, and is witnessed today with the wide support given by medical colleagues from other countries, all cooperating on essential clinical and public health research. sadly, osler died in at age the of from spanish influenza while teaching at oxford (england). the spanish influenza was also called "swine flu" because it allegedly jumped from live pigs to humans, killing one-quarter of the world's population. the capacity for swine flu to survive and to initiate a second pandemic in was possible because it thrived and spread as a new mix of genes from swine, birds, and human flu viruses. we now live in an age of epidemics and pandemics. predictably, and in its own time, the swine flu will reemerge once again. modern day scholars have taken the "one medicine" concept and advanced it into the "one health initiative," a movement that seeks to "forge greater collaboration between the health disciplines," advocating for multidisciplinary efforts to improve global health in general. it became a globally shared concept and world-wide strategy for expanding interdisciplinary collaborations and communications in all aspects of health care for humans, animals, and the environment. the synergism accelerated "biomedical research discoveries, enhancing public health efficacy, expeditiously expanding the scientific knowledge base, and improving medical education and clinical care." when properly implemented, the "one medicine" concept would help protect and save untold millions of lives in present and future generations. this concept eventually incorporated specific expertise in biohazard events, food and water safety, vector-borne diseases, established and emerging zoonotic diseases, herd health, foreign animal risks, and public health issues such as antimicrobial drug resistance. this would come to define one health advocates and practitioners of the future, and today defines what we now refer to as the operational elements of "global public health." beginning in the s, major economic and political changes occurred when economically leading western countries developed businesses in third world countries, a process referred to as "globalization." with it came the realization that the economy was a major force behind the setting of public policies, including health policies. increasingly, the process revealed that the power of governments to shape national policy was, in many cases, being considerably limited and diminished by an increasingly competitive international economy where some countries impacted by globalization either thrived or collapsed. global health experts, and those focusing on humanitarian and crisis management, who were excluded from any cross-cultural economic debates, closely watched from afar how and where public health infrastructure and protections in water, shelter, food, and availability of health services would either benefit or suffer from globalization. too often, local public health and the global health priorities they impacted took a backseat to economic demands resulting in "weakening of life-supporting systems," specifically "altered composition of the atmosphere, land degradation, depletion of terrestrial aquifers and ocean fisheries, and loss of biodiversity." these are elements known today that can lead to acquiring and spreading of epidemic infections such as sars, h n , and influenza. health and public health were never at the same globalization negotiating table, but were more often silently relegated to a catchup role that tried to mitigate the impact on health caused by increasing globalization. with increasing globalization and speed of transportation, infections rapidly began migrating across borders. yet who, now equipped with improved telecommunications, developed an increased capacity to readily detect emerging epidemics, a major improvement never before available with previous epidemics and pandemics. an encouraging aspect of globalization was the increasing number of the millennial generation who studied abroad and worked on various humanitarian missions. as a result, they began seeing themselves less as nationalists and more as global citizens. , however, with the recent rise and dominance of authoritarian regimes and populism, globalization has essentially noticeably faded and is rapidly becoming a non-entity. both the word "globalization" and its concept have disappeared under a coordinated false narrative campaign promoted by autocrats and rising nationalist state movements. , ghitia contends that "modern-day would-be dictators don't overthrow another government. what they do is take over the system of government." she emphasized that their methods are more gradual, "manipulating the democratic norms, wearing them down to a thin shell that contains only the wrecked remains of democracy." by the time most people realize what happened, it is too late to push back. i talked to an investor once active in the globalization movement, asking what was going to happen with the large number of desperately needed public health infrastructure projects. his response was, "only if they can show us a profit." in past decades, human population densities were much too low for viral illnesses to widely occur and outbreaks were, more often than not, driven almost exclusively by natural disasters, predatory animals, and prolonged wars. globally, zoonotic spread occurred simply because the human population has grown in numbers and become more dense. the spread was enhanced and accelerated by rapid unsustainable urbanization, biodiversity loss, climate change, and its extremes. this has resulted in producing further viral engagement with an increasing number of a new vulnerable populations suffering from chronic deficiencies in food, water, and energy. the current sars covid- transmission that flourished in wet market animals, whether it be a bat or civet, spread easily to the human-animal, a perfect host. the chaos created by the rapid spread of covid- has created an unprecedented opportunity for state-sponsored disinformation. probably the most infamous infectious disease disinformation incident was the kgb's "operation infektion" in the s, which blamed the united states for the creation and spread of hiv. although the union of soviet socialist republics (ussr) conceded in that the kgb had instigated and perpetuated the myth, considerable damage was done, most importantly global distrust of the "official narrative" which fed into claims that hiv does not cause aids and distrust that the anti-retroviral used to treat hiv was useless, resulting in more than , preventable deaths. what continues today is a russian autocratic regime that still places greater emphasis on false epidemic narratives than solving its own fastgrowing global rates of hiv/aids and tuberculosis (tb). russia and china are exploiting both real-life mistakes and weaknesses in the information space to control and modify the narrative with impacts on geopolitics and national security. spreading conspiracy theories from china, russia, and the united states is rampant, all systems designed to deflect responsibility for their bureaucratic failures. china is now seeking to blame the united states for covid- claiming, "further evidence that the virus originated in the us" and was planted in china by the us army. russia is sowing divisions between and within western countries to undermine public confidence in government competence and integrity. the who, despite having in-hand evidence to the contrary, failed to properly contain the covid- pandemic. china's gross denial and failure to investigate and alert other nations is inexcusable. moreover, its malignant behavior toward clinicians and researchers who warned the government of the outbreak, when the virus was first known as far back as october of , is equally inexcusable. yet the february - , "report of the who-china joint mission on coronavirus disease " singularly praised china's response as the best source of medical technology to deal with the pandemic. china then declared that their singular success in controlling the pandemic should qualify them to take over the who. while the european union and the united states struggle to control the covid- pandemic, who fully supports china's "one belt, one road" initiative across africa to improve the economy of the continent. however, the lessons from globalization prove that economic prosperity alone cannot be achieved when huge knowledge and capacity gaps exist in health systems, especially public health and health information systems. there is a need for public health initiatives aimed at strengthening the health systems beyond sovereign borders to influence global geo-economics. whereas who has fully supported this initiative with claims that china is investing in "people's health outside its border," the deplorable cover-up, response, and management of covid- for many months before it was known to the world questions whether china is up to the public health challenges it claims in africa, or fully understands the vital connections economic development has with public health. china claims that ruling africa's economy is a necessary prelude to the "next phase of globalization." ever since who first announced the presence of clusters of unknown pneumonia on december , , an alarming concern has surfaced that who has become beholden to influential countries for funding support, giving wealthy un members, especially china, support and influence both before and during the coronavirus outbreak. for example, who's position regarding china has renewed a longstanding debate about whether who, founded years ago, is sufficiently independent to allow it to fulfill its purpose. critics raised questions concerning who's response over how "china's sway over the who is its success in blocking taiwan's access to the body, a position that could have very real consequences for the taiwanese people if the virus takes hold there." others cite that who "downplayed the harsh control of medical whistleblowers," and the critical delay in revealing covid's presence, and further argue that who is "overly bureaucratic, bizarrely structured, too dependent on a handful of major donors, and often hamstrung by political concerns." with the covid- crisis, "the state of politics and geopolitics has exacerbated, not stabilized, the crisis." this applies to many countries, especially china, the united states, japan, cambodia, iran, and south korea. authors cite former who consultant charles clift who observed, as have many former insiders, that who "is too politicized, too bureaucratic, too dominated by medical staff seeking medical solutions to what are often social and economic problems, and too timid in approaching controversial issues, too overstretched, and too slow to adapt to change." he added that who, being "both a technical agency and a policymaking body, that excessive intrusion of political considerations in its technical work can damage its authority and credibility as a standard-bearer for health." , united states' president trump has not done better in what must be a coordinated world response. his idea of "america first and national populism" is against everything that we believe in global health. in january , china made available the "genome" of this mysterious new virus in hopes of producing the first diagnostic test for the disease, but the united states declined to use the who test even temporarily as a bridge until the us centers for disease control and prevention (cdc; atlanta, georgia usa) could produce its test. this action remains a perplexing question and the key to the trump administration's failure to provide enough tests to identify the coronavirus infection, needlessly slowing the critical domestic testing process and surveillance. additionally, president trump's reliance on the validity of his "hunches," claimed who's mortality rate was "false," irresponsibly valuing his "best guesses over scientific analysis." this has led to a "false sense of security that endangers public health." both china and the united states have public health infrastructure and service deficiencies that have gone unattended for decades. public health infrastructure in the united states makes up only three percent of health care spending focused on prevention and public health, while % of health care costs are related to preventable conditions. china chronically suffers low public health standards in toilets, restaurants, hospitals, and meat markets; and the united states has states and very different health department ratings. as an example, during the covid- pandemic, mississippi, which rates last in public health infrastructure, has created confusion with many of its mayors claiming the need for curfews and closing of businesses, only to be over-ridden by the state's governor. the only solution the who must exist solely as a treaty-based organization sanctioned by the un and all its members. it cannot be dependent on outside financial assistance to do its work. the unique characteristics of propagating zoonotic diseases must be better known by both the medical profession and governmental decision makers. health care experts, as osler described, must be in charge of all health decisions, monitoring, response, and operational research. they cannot abdicate any responsibilities to individual nationstates nor be beholden to them or well-financed donors for support. current disaster taxonomy describes diversity, distinguishing characteristics, and common relations in disaster event classifications. the impact of compromised public health infrastructure and systems on health consequences defines and greatly influences how disasters are observed, planned for, and managed, especially those that are geographically wide-spread, population-dense, and prolonged. the one health concept helps to set the path forward for a solution based on local grassroots coordination, and a bottomup capability driven by medical, veterinary, and public health practitioners. this must include rapid, networked information sharing and the use of multiple expert disciplines to mitigate an outbreak. lastly, public health and public health infrastructure and systems in developing countries must be seen as strategic and security issues that deserve international public health resource monitoring. this must cover the entire disaster cycle from prevention, preparedness, response, recovery, and rehabilitation. all six who regional offices must have similar multidisciplinary professional assets in support of zoonotic sciences. as osler might declare today, "there is so much more we need to know!" world health organization. managing epidemics: key facts about major deadly diseases do we still need international health regulations? the international health regulations: the governing framework for global health security global health security demands a strong international health regulations treaty and leadership from a highly resourced world health organization types of zoonotic diseases from "one medicine" to "one health" and systemic approaches to health and well-being animals at your doctor's office? one health, one solution. lifeapps aequanimitas: with other addresses to medical students, nurses, and practitioners of medicine osler centenary papers: management of pleural infection: osler's final illness and recent advances investigating interdisciplinary collaboration: theory and practice across disciplines the growth and strategic functioning of one health networks: a systematic analysis the global one health paradigm: challenges and opportunities for tackling infectious diseases at the human, animal, and environment interface in low-resource settings comment: whose globalization? public health policy forum the changing global context of public health the hyogo framework for action: cautious optimism hyogo declaration and the cultural map of the world character disorders among autocratic world leaders and the impact on health security, human rights, and humanitarian care globalization is dead, but the idea is not dictatorship, st-century style. cnn: opinion notes & theories: aids and hiv. the guardian the us-china coronavirus blame game and conspiracies are getting dangerous. the washington post covid- ) china's belt and road initiative: incorporating public health measures toward global economic growth and shared prosperity discussion paper: china's role in the next phase of globalization. mckinsey global institute the coronavirus crisis is raising questions over china's relationship with the world health organization. us & world the coronavirus is exposing the limits of populism the coronavirus crisis is raising questions over china's relationship with the world health organization. cnn the coronavirus panic exposes the pathology of nationalism. common dreams how testing failures allowed coronavirus to sweep the us coronavirus death rate is . %, world health organization says, trump says 'hunch' tells him that's wrong. usa today strengthen public health infrastructure and capacity f % f % fis-china-ready-this-major-global-health-challenge% f& closing businesses amid virus could do harm. fox impact of public health emergencies on modern disaster taxonomy, planning, and response challenges of global public health emergencies: development of a health-crisis management framework key: cord- -j vylbhy authors: martin, r. title: the role of law in pandemic influenza preparedness in europe date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: j vylbhy the european union (eu) is composed of states with widely varying histories, economies, cultures, legal systems, medical systems and approaches to the balance between public good and private right. the individual nation states within europe are signatories to the international health regulations , but the capacity of states to undertake measures to control communicable disease is constrained by their obligations to comply with eu law. some but not all states are signatories to the schengen agreement that provides further constraints on disease control measures. the porous nature of borders between eu states, and of their borders with other non-eu states, limits the extent to which states are able to protect their populations in a disease pandemic. this paper considers the role that public health laws can play in the control of pandemic disease in europe. the states of the european union (eu) form a political and economic community with supranational and intergovernmental responsibilities, and constitute a single market that seeks to guarantee the freedom of movement of people, goods, services and capital between member states. the emergence or re-emergence of diseases such as severe acute respiratory syndrome (sars) and tuberculosis highlighted the need for eu-level health policy, and led to the community action programme - in the field of public health. this programme is now the cornerstone of community public health strategy, focusing on health information and on the community's capacity to react to health threats. in the context of disease control, the executive arm of the eu, the european commission (ec), has responsibility for the co-ordination of epidemiological surveillance of disease between member states and for regulating matters such as case definitions, disease notification and development of disease networks across europe. the ec is assisted by the european centre for disease control (ecdc), which issues protocols on matters of disease reporting and communication of disease information between states and to the ec. the ec and ecdc can only recommend appropriate disease control measures to states. neither is responsible for the management of disease protection and control in individual states. public health powers in relation to disease lie with national governments. it is member states, not the eu, which are signatories to the revised international health regulations (ihr) , although the ihr recognize the role of 'regional economic integration organizations' such as the eu. a thus, if the world health organization (who) were to recommend under the ihr measures falling within eu legislation, such as restrictions on the movement of goods or the processing of personal data, b the eu would need to act collectively, at the initiative of the ec, as member states would be unable to take unilateral action. otherwise, ihr responsibilities lie with individual states. in , a report on pandemic influenza preparedness in the eu noted that substantial progress had been made in preparing for a possible pandemic influenza, but it remained the case that disease control operated at national level. despite encouragement from the eu towards harmonization of approaches, european national plans vary widely in the strategies they have adopted and the public health powers they propose for implementation of those strategies. harmonization of legislative responses to infectious diseases, based upon sound evidence, will be necessary if collaborative efforts in support of infectious disease control are to be effective. to assist in drawing together national responses to pandemic disease, the phlawflu project c was funded to develop public health law expertise across europe, and to examine the legal underpinning of pandemic disease preparedness across the eu and five further european states. d this paper examines obstacles to european commonality of legal responses to communicable disease. there is no doubt that law is an important tool in containment of communicable and non-communicable disease. in the context of pandemic influenza, it is considered that social measures authorized by law will be at least as important as medical interventions. evidence from the influenza pandemic suggests that compulsory home isolation and quarantine were not particularly effective disease control measures because of the difficulty in diagnosing mild cases. nor were such measures likely to be feasible beyond the initial cases. however, compulsory interventions such as school closures, closure of public places and restriction of mass gatherings, along with disease surveillance and hygiene improvement, have proved effective both in influenza outbreaks and in the sars epidemic. international and eu instruments require states to undertake such measures, many of which will require a legal underpinning. the requirement of compliance with the revised ihr and the globalization of disease information and exchange have prompted many states to revise their public health laws. other states, which had no public health legislation, have now enshrined public health laws in legislative form. these initiatives were long overdue. across europe, as elsewhere, national public health laws tended to be old, based on flawed science, and to predate contemporary understandings and protection of human rights. , the allocation of responsibility for public health practice and the role of the state in regulating private behaviours have very different histories across europe. not surprisingly, states have adopted very different positions on the issue of the extent to which constraints can be placed upon individuals for the public benefit. earlier research on european national public health laws in relation to tuberculosis enabled the identification of four different 'families' of public health legislative models in europe. these were: authoritarian (the enforcement of a high number of compulsory control measures); moderate (the enforcement of predominantly compulsory control measures without recourse to prevention powers such as compulsory vaccination or population screening); preventive (where compulsory provisions were oriented towards preventive measures, including screening, medical examination and/or vaccination, rather than compulsory treatment or detention); and the laissez faire model, where few or no compulsory measures existed. a further complication to a comparison of national legal approaches to disease control is the range of different legal systems in europe. while the majority of european states have a civil law legal system based on the french or german systems, some states operate common law systems, e the former soviet states have vestiges of soviet law, and the legal systems of the scandinavian states recognize civil law overlain with some common law. whereas the definitive public health law of some states can be found in statutory form, other states also include the binding decisions of courts. some national legal systems recognize customary law, local edicts or administrative orders as having legal authority. it cannot be assumed that because a particular power does not lie within public health legislation, that power does not exist. determination of the full range of public health legal powers across european states is a technical and difficult task. following the eu working paper on community influenza pandemic preparedness and response planning in , european states have published national preparedness plans. as with the range of approaches to law, there is a wide range of approaches to pandemic preparedness planning across europe. coker and mounier-jack examined european national plans against a who checklist and found considerable gaps and inconsistencies among preparedness plans, with implications for health in both individual states and for europe as a whole. the authors noted that 'the eu has a critical function in protecting its citizens from public health threats. the role of the eu will be essential to ensure improved sharing of knowledge on pandemic response among eu members, to support the effective provision of services, and to coordinate the response at a community level'. few plans address the extent to which proposed interventions are authorized by their national laws. indeed, few state plans acknowledge the need for legal authorization for their proposed measures, and there is often a lack of clarity about the legality of measures. f while there is some commonality across european states in the measures considered appropriate in an epidemic, the formulation of those measures differs from state to state, reflecting the culture and social priorities of individual states. across europe, states have proposed disease reporting networks, social distancing powers, restriction on travel and trade, closure of premises and facilities, and measures regulating the provision of goods and services. however, the extent and scope of these powers vary widely. while most states contemplate powers of isolation and quarantine, some states also propose quarantining flight crews, and authorize compulsory vaccination, compulsory administration of prophylaxis, and compulsory medical treatment. most states authorize the closure of schools and leisure facilities in a pandemic, but some states would also close diplomatic and consular representation, restrict trade union activity or prohibit visitors to inpatients in hospitals. there is variation in the extent to which states will be prepared to requisition persons and property. many states have passed, or are in the process of passing, new legislation to support their preparedness planning. in england and wales, for example, the health and social care act has introduced into the public health act new powers of isolation outside a hospital, powers of quarantine, powers to require the wearing of protective equipment, powers to require people to attend counselling or disease risk training, and the power to require individuals to provide health information. it also provides for the application of compulsory power orders to groups of persons as well as to individuals, provides new border control measures and imposes new obligations to monitor health risk. states that had taken a liberal approach to intrusion on individual liberties for the benefit of the public health have, in the face of the threat of a pandemic, passed laws providing considerable public health powers. french public health law had previously c the phlawflu project has received funding from the eu in the framework of the public health programme. d croatia, turkey, iceland, liechtenstein and norway. e including the countries of the uk, ireland, malta and cyprus. f the spanish preparedness plan, for example, expresses concern regarding the legality of proposals for isolation, restriction of movement and the proposal to make compulsory the administration of antivirals to staff in contact with patients, noting that 'the legal services of the ministry of health will need to study the legal aspects relative to compulsory vaccination and isolation and the restriction of movement according to the constitutional act / of april of special public health measures in public health, articles and '. focused on preventive measures and provided few compulsory powers for disease control. the new french public health code now authorizes isolation and quarantine, obliges individuals to submit to temperature checks, and provides powers to close facilities such as schools, restrict use of public transport, requisition health personnel including students and retired persons, and regulate distribution of medicines. school buildings will be used as centres for vaccination and for accommodation of vulnerable persons. the new code withdraws employment rights such as the right not to work in a situation of danger. employees and public servants in france currently have the right to withdraw from their workplace if they reasonably believe that their work situation presents a grave and imminent danger to life and health, provided that they have alerted their employer to the danger and provided that their leaving does not create a new risk for others. under the new code, which only applies in the particular case of pandemic influenza, this right of withdrawal will not apply in circumstances where the employer has taken all foreseeable measures to reduce the risk of exposure to disease. the formulation of public health measures across europe reflects cultural values and priorities. french law, for example, proposes the possible closure of schools in an epidemic, but the new french public health code, recognizing the importance of education in france, provides very specific measures to protect the right to education of its children. the code acknowledges the need for school closures because children are more susceptible to the influenza virus than adults. however, the code requires that during a school closure, every effort must be made to continue educational provision via the internet, radio and television, and sets out detailed provisions on ways in which education might be continued throughout the pandemic. the difficulty of predicting what legal powers will be needed to exercise effective disease control has led some states to include in their public health legislation a power to make emergency regulations to provide powers that were not foreseen or which would not be appropriate outside an emergency. the health and social care act for england and wales, for example, proposes that where there is sufficient urgency, a legal instrument may be made without following normal parliamentary procedures. the regulation will then cease to have effect after days, unless it has been ratified by a resolution of each of the houses of parliament. the new french code allows that in the case of a grave threat calling for urgent measures, particularly in the case of an epidemic, the minister responsible for health can, by means of an arête, dictate in the interest of public health measures that are proportionate to the risk and appropriate to the time and place, in order to prevent or to limit the consequences of possible threats to the health of the population. in addition to emergency powers specifically addressed to pandemic disease, many european g and other h states have also introduced or updated separate emergency powers legislation to address unexpected threats, to authorize measures that would not normally be acceptable, or to provide powers as a last resort in the face of emergencies where existing legislation is insufficient. other states have constitutional provisions authorizing emergency powers. i it has until now been the case that for the purpose of legislation, emergencies have been conceptualized as aberrations, normally involving an aspect of violence such as war, rebellion or a violent natural disaster. european emergency powers have generally been limited to a 'state of siege' (france), armed rebellion (hungary), or industrial and natural disasters such as earthquakes or the forest fires in greece. they have not been considered a tool for disease control. in the uk, the civil contingencies act has replaced the emergency powers act j in relation to temporary special legislation to respond to serious emergencies. the emergency powers act had provided power to make emergency regulations, following a royal proclamation of a state of emergency, in case of an interference with the supply or distribution of food, water, fuel, light or the means of locomotion that deprived the community, or part of it, of the 'essentials of life'. the civil contingencies act expands the domain of emergency powers so that an emergency is widely defined to include 'an event or situation which threatens serious damage to human welfare', which could potentially include a public health threat such as a serious disease outbreak. while no regulations have been passed to date, there is clearly scope for a heavy-handed response in the event of a public health threat. the civil contingencies bill in its original form underwent prelegislative scrutiny by a joint committee which noted that the bill: ' in the wrong hands, [the bill] could be used to undermine or even remove legislation underpinning the british constitution and infringe human rights. our democracy and civil liberties could be in danger if the government does not take account of our recommended improvements'. the bill was revised and the government agreed to remove a clause that would have prevented emergency regulations from being subject to judicial review with the consequence that the regulations could not be suspended or struck down by a court if they were challenged on human rights grounds. the committee recommended that certain acts of parliament of major constitutional significance should be exempted from a power to modify or disapply legislation, but this remains in the final legislation. the committee also proposed that those powers set out in part of the bill should be subject to a 'sunset clause' and expire every years from royal assent unless renewed by parliament. this was rejected by the government as inappropriate, because the bill contained enabling powers that were intended to deal with a problem that was 'not short-term'. this suggests that a new approach is being taken to the meaning of 'emergency'. under earlier emergency powers legislation, an emergency was determined by a royal proclamation, but under the civil contingencies act, a state of emergency is to be announced, without initial reference to parliament, by the secretary of state or a senior minister. public health emergency planning in the uk appears to acknowledge that the civil contingencies act will have a more general role in the control of disease, although how these plans relate to new powers under the public health act remains to be seen. a senior spokesperson from the english department of health told the author that the department does not intend to use emergency powers contained in the civil contingencies act for pandemic influenza. powers, contained in the health and social care act should provide all the necessary legal powers to contain and control disease. however, it is clear from government documents on pandemic planning that there is every expectation that civil contingencies act powers will be used should the need arise. , the finnish national preparedness plan for pandemic influenza recommended amending finland's emergency powers act so that a major epidemic can be classified as a state of emergency as defined in the act. previously, an emergency was defined to include an armed attack against finland, a serious violation of the territorial integrity of finland, a threat of war, a serious threat to the livelihood of the population or the economy by interrupted import of indispensable fuels and other energy, or a catastrophe. finland's communicable disease act of already contains quite intrusive powers including the power to administer compulsory mass vaccination by the defence forces, compulsory medical treatment, isolation from the workplace, and disease reporting that discloses personal information. the concern with use of emergency powers for disease control is that disease control ceases to be a matter of health protection, and becomes an issue of foreign and national security, with the risk of being hijacked by the agendas of security policy and politics. ,l this has become even more pronounced with the merging of responses to naturally occurring infectious disease and bioterrorism within emergency powers legislation. the who and european commission have both established committees with responsibility for public health as a security issue. m it is questionable whether the suspension of separation of powers and potentially of civil rights and liberties is justified in the name of public health, and arguable that recognition of human rights is essential for dealing effectively with an epidemic. draconian quarantine measures can be counterproductive, and may even encourage people to avoid seeking medical treatment. emergency powers exercised for public health reasons treat citizens as the enemy, and reinforce the philosophy of original public health legislation which classified diseased persons as a public health nuisance to be removed and excluded from society for the benefit of the well. hong kong, which has had recent experience of epidemic disease, considered but rejected expanding its emergency regulations ordinance to cover pandemic influenza, concluding that public health powers were sufficient and appropriate to disease control even during a pandemic. n hong kong has instead amended its quarantine and prevention of disease ordinance in the light of its sars experience. emergency powers and human rights all council of europe member states are party to the european convention for the protection of human rights and fundamental freedoms, and any person whose convention rights have been violated by a state party can take a case to the european court of human rights. in the uk, the human rights act brings provisions of the convention into uk domestic law and enables human rights actions to be brought in a domestic court. rights with particular relevance to public health powers include article (right to life), article (an absolute right to freedom from torture and inhumane and degrading treatment), article (a qualified right to liberty) and article (a qualified right to private and family life). in enhorn v sweden, a human immunodeficiency virus (hiv)-positive man detained by swedish public health authorities on public health grounds successfully challenged his detention on the grounds that it breached articles and of the convention. the european court of human rights held that any detention must comply with the principle of proportionality, there must be an absence of arbitrariness, detention must be a last resort measure, and any detention must have as its objective not only protection of the healthy but also care of the ill. there has been little judicial challenge in british courts of the exercise of emergency powers. in relation to the english emergency powers act and the emergency powers (defence) act, the courts have played a minimal role, striking down only a handful of emergency measures as ultra vires, usually well after the emergency. more recently, in a case where the british parliament had sanctioned the indefinite detention of any person not a british citizen and certified as a 'suspected terrorist', and where the government had derogated from both the european convention and the international covenant on civil and political rights (iccpr) on the grounds that there was a 'public emergency', the house of lords rejected the government's assertion that the derogation was consistent with the european convention. although the majority of judges declined to question whether there was a public emergency on the grounds that the existence of such an emergency was largely a matter for the government to determine, they concluded that imprisonment of non-citizens alone was neither proportional, given the equal threat from citizens, nor necessary, and questioned the irrationality of singling out a minority (non-citizens) for special burdens, when members of the majority could present an equal risk. lord hoffmann was prepared to consider the notion of an emergency and he found it to be a threat to the 'organised life of the community', which would include not merely a threat to the physical safety of the nation, but also to its fundamental values: 'the real threat to the life of the nation, in the sense of a people living in accordance with its traditional laws and political values, comes not from terrorism but from laws such as these.' the decision suggests a judicial role in overseeing government powers in emergencies. the concept of a 'public emergency' is considered under article of the european convention for the protection of human rights and fundamental freedoms as 'a situation of exceptional and imminent danger or crisis affecting the general public, as distinct from particular groups, and constituting a threat to the organised life of the community which composes the state in question.' o article allows that states might derogate from some of their obligations under the convention 'in time of war or other public emergency threatening the life of the nation', but not from article (right to life) or article (prohibition of torture and inhuman or degrading treatment). the former european commission of human rights, which in defined a public emergency to consist of a 'threat to the organised life of the community', was called upon to determine the criteria of a public emergency threatening the life of the nation in a case in which the greek government sought to justify derogation of rights on grounds of a public emergency. the commission held that the emergency must be actual or imminent; it must affect the whole nation; the continuance of the organised life of the community must be threatened; and the crisis or danger must be exceptional, in that the normal exceptions permitted by the convention for the maintenance of public safety, health and order are inadequate. derogations may only last for as long as, and only be exercised to the extent required by, the demands of the circumstances. they must not limit the subject's rights of access to court protected in article of the convention, nor the right of a remedy protected in article . in circumstances where a state wishes to exercise emergency powers which might contravene human rights, the state is required to make a formal derogation under article of the european convention indicating the rights and the territory to which the derogation applies, and to keep the secretary general of the council of europe informed of the measures taken, the justifications, and the cessation of operation of emergency powers. similar requirements can be found in the iccpr. if european states are to abide by their commitments under the convention, it seems that use of emergency powers will be subject to human rights examination. states will not then be able to exercise their powers in an arbitrary way, and will not be able to respond in a manner that is not proportional to the risk. despite these safeguards, the use of emergency powers legislation for serious ongoing disease outbreaks is questionable. an influenza epidemic could, on a worst case scenario, last for years, which would potentially allow the operation of emergency powers that derogate from human rights protections for a considerable period of time. there is a danger that laws made in the form of emergency regulations might, if in force for long enough, become embedded in the legal system and so constitute a permanent assault on liberties which had previously been achieved, as might be suggested of terrorism legislation in the uk. emergency powers in the context of disease, based as they are on responses to war and catastrophes, tend to operate in such a way that persons affected with disease are characterized as the enemy. they propose that in public health emergencies, there must be a trade-off between the protection of civil rights and effective public health interventions. however, the ideals of democracy, individual rights, legitimacy, accountability and the rule of law suggest that even in times of acute danger, government should be limited in the activities that it can pursue and the powers that it can exercise. as gostin points out in the context of the us model state emergency health powers act, this is not to say that individual rights should always trump public health, but that individual rights should never be infringed 'unnecessarily, arbitrarily or brutally'. nevertheless, there has been significant criticism of the us legislation, and concern that measures proposed in the act are sufficiently dangerous as to 'undermine.constitutional values'. while emergency powers might provide short-term solutions to serious threats, they could also do long-term harm to public trust in public health services, and encourage health behaviours which are counterproductive to the public health. in many countries, including the usa, there are signs that public health and national security are increasingly conflated. the ihr are framed around the assumption that disease is a security issue. however, the danger of subsuming disease control within foreign and national security is that the focus is on security rather than on health. wider national and international interests may not always coincide with public health. global public health may not always coincide with the security concerns of individual states, particularly more powerful states. mcinnes and lee note that policy responses to the sars epidemic elicited a 'garrison mentality' whereby strict border controls and control of movement of persons became central to disease containment, with consequences for the movement of persons, goods and services. it has been widely argued that the promotion and protection of human rights is inextricably linked to the promotion and protection of public health, and that lack of respect for the rights and dignity of persons or groups of persons can increase their vulnerability to disease contagion. , the importance of human rights to health has been acknowledged in the revised ihr article , which requires that the ihr be implemented with full respect for the dignity, human rights and fundamental freedoms of persons. as mann argues, '.the human rights framework is indispensable both for analyzing the central societal issues which must be confronted and for guiding the direction of societal transformation needed to promote and protect health.' states have a significant number of non-medical tools at their disposal in a disease pandemic, and public health law reform has been undertaken with pandemic influenza in mind. public health legislation around the world now authorizes a wide range of social distancing powers and compulsory screening, examination and treatment measures. in addition, much public health legislation provides for the possibility of some limited emergency measures. nevertheless, some european states have proposed the use of emergency powers legislation to provide exceptional powers in the case of a pandemic; powers which will inevitably constrain the rights of individuals. the evidence base for the need for such exceptional powers has yet to be established, and in the absence of such evidence, there is concern that too heavy a hand will result in long-term harm to public trust in the exercise of population-based disease prevention strategies. early responses to public health threats as reflected in th century public health legislation were premised on building fortresses to protect the healthy (and generally wealthy) from those suffering from disease, rather than on care and protection of the population. public health legal powers tend to focus on containment and exclusion, representing 'the community response to social and economic pressures and the wide spread fear of death and disease' rather than on positive public health outcomes. immigrant populations have long been targeted as carriers of disease, and in relation to diseases such as drug-resistant tuberculosis, increasing incidence in the western world is often attributed to persons entering from states with high tuberculosis rates. much contemporary public health policy has rejected the 'fortress' approach to disease control in favour of seeing the public health mandate as imposing duties upon all members of a society or population, or indeed duties of global health protection. the evidence base for border control as a public health, as distinct from a security, measure is limited, especially in a pandemic. in relation to other diseases such as hiv and tuberculosis, border screening has proved to be unreliable and has shown little benefit for the health of the population. compulsory border screening and refusal of entry to affected persons are contemplated by many states in their pandemic influenza preparedness plans, p and the revised ihr contemplate that who might recommend refusal of entry of suspect and affected persons and refusal of entry of unaffected persons to affected areas, subject to the ethical consideration of respect, to the extent possible, for the individual right to freedom of movement. article of the ihr requires all signatory states to establish points of entry with surveillance and border control capacities. a consequence of having no internal eu borders is that the eu needs a strong common external border. under the eu free p for example, bulgaria, denmark, greece and latvia. movement directive, member states may deny entry of eu citizens and their family members if they are considered to be a threat to public health, but only if this is proportionate and meets strict material and procedural safeguards. most eu member states q have signed the schengen convention, eliminating border controls between participating countries and creating an external frontier. the convention called for a common visa policy, harmonization of policies to deter illegal migration, and an automated schengen information system to coordinate actions in relation to individuals who had been denied entry. the amsterdam treaty incorporated the schengen convention into eu treaties, and set out a plan to integrate policies on visas, asylum, immigration and external border controls into community procedures and into the community legal framework. this has resulted in what is for all intents and purposes an eu external border, with much social and economic activity operating at regional rather than national level. however opt-out r and opt-in s possibilities make it difficult to define an administrative space that falls within the frontier, and there is no overarching political control. rather, decisions are made by means of a complexity of intergovernmental and supranational institutions, and there remains considerable sovereign power in relation to many issues of border and public health relevance. the schengen agreement includes consent to share information about people, via the schengen information system. this means that a person cannot 'disappear' simply by moving from one participant country to another. a country is permitted by article . of the schengen agreement to reinstate border controls for a short period if it is deemed to be in the interest of national security. any schengen country can impose temporary or permanent border controls if it believes itself to be unprotected by other members. under this provision, portugal restricted border entry during the european football championship, as did france for the ceremonies marking the th anniversary of d-day, and again shortly after the london terrorism bombings of july . with foot-and-mouth disease having been confirmed in france, the netherlands and britain, norway, in particular, put its border officers on high alert to prevent spread of the disease into the country. other nordic countries have also increased spot checks on entries into the region, irrespective of their new borderless status, in an attempt to contain foot-and-mouth disease. under the schengen borders code, third-country nationals may be refused entry if considered a threat to public health. one issue that arises from the lack of border controls within europe is the disparity in levels of disease preparedness across europe. in , new member states joined the eu, eight of which are former communist countries in central and eastern europe (slovenia, hungary, czech republic, poland, lithuania, latvia and estonia). these states are characterized by a history of underfunding of health and surveillance systems, unreliability of access to drugs, continuing increase in diseases such as drug-resistant tuberculosis and hiv/acquired immunodeficiency syndrome, and inadequate public health responses to disease. since these states have entered into the eu, citizens can cross borders into other, better-resourced states. in the context of a pandemic, this could mean an influx of persons who are possible disease carriers from poor states with a frail public health system and with insufficient medicines, to other eu states, putting citizens at risk and draining health resources in those states. this creates difficult choices for host countries in terms of the assistance they offer. should they fail to offer healthcare services to mobile populations, these populations will put state population health at risk. should they offer healthcare services to mobile populations, this will strain resources and drain services from home populations. in their comparative study of european national preparedness plans, mounier-jack and coker found that eu states intended to take at least one measure to restrict travel to and from the state during a pandemic, and of these states recommended border restrictions on entry and departure. one state proposed drafting new laws to give stronger border control powers. other states, however, conceded that by phase of a pandemic, while there might be political grounds for restrictions on travel, there would be little public health benefit. the possibility of border closure was an issue examined in exercise common ground, a pandemic influenza exercise for the european union, conducted by the uk's health protection agency over a -day period in november . this was the second of two eu exercises commissioned by the ec to evaluate the ability and capabilities of member states to respond to a health-related crisis, in this case an influenza pandemic. concern was expressed when switzerland indicated that it might consider the closure of its borders, given the location of drug manufacturers in switzerland. france's border closure proposals contained exceptions for pharmaceutical and vaccine materials and workers. the feasibility of instituting border controls within europe in a pandemic was then examined at an eu pandemic influenza workshop in august . it was concluded that while border closure might be a useful early containment strategy, at a pandemic stage, it would be impractical to enforce border controls within europe because of the porous nature of european borders and because of the need for cross-border traffic of goods. any prolonged border control would disrupt critical supply chains, and there was a risk that the consequent disruption of border controls within europe would result in greater harm than benefit. screening at borders for diseases such as tuberculosis and hiv is common practice in many states, but has been much criticized on grounds of evidence and ethics. a systematic review looking at the effectiveness of physical interventions such as screening in relation to respiratory viruses concluded that '(g)lobal and highly resource intensive measures such as screening at entry ports.lacked proper evaluation'. there is also limited evidence regarding the efficacy of screening international passengers on departure or arrival in a flu pandemic, except possibly in the early phase. while control and screening measures may have worked in the days of slow travel, it is now the case that travel times are likely to be shorter than incubation periods, such that port screening will be ineffective in disease identification. nevertheless, the mounier-jack and coker study found that eight eu states proposed entry screening in their pandemic preparedness plans. some european states indicated in exercise common ground that they intend to undertake border screening regardless of the evidence base, on the grounds that such measures provide reassurance to the public, and because the surveillance information might prove useful. the ihr authorize states to require information from travellers about their travels, and to undertake a non-invasive medical examination which is the least intrusive to achieve the public health objective. entry may be refused where the traveller refuses to co-operate. article of the ihr provides that invasive medical examination, t vaccination or other prophylaxis shall not be required as a condition of entry except in limited circumstances, such as to determine whether a public health risk exists, or in relation to persons seeking temporary or permanent residence. in these circumstances, if a traveller refuses to comply, entry may be refused or be made subject to the least invasive procedure to achieve the public health objective. article stipulates that such measures be undertaken within the confines of express informed consent and national and international safety guidelines, and article requires that in implementing measures, travellers are to be treated with dignity and respect, and with recognition of gender, sociocultural, ethnic or religious concerns. within the eu, border measures are a matter of community competence that require state co-ordination. where eu member states intend to adopt border measures for the control of communicable diseases, they must inform and, where possible, consult other member states and the commission in advance. the exercise common ground report and the eu pandemic influenza workshop concluded that there was variability in the extent to which member states, european economic area states (including all eu countries plus iceland, norway and liechtenstein) and switzerland have included an international dimension in their pandemic influenza plans. rather, they have focused on national, domestic issues. it is necessary to consider an international dimension because: 'in a community like the eu, free of internal borders and with many common activities and free movement of people and goods, any countermeasures taken in one member state will be bound to affect at least some if not all, other member states'. the reports noted that states also needed to address issues surrounding expatriates, travel restrictions, restriction of emigration, issues of contact persons and the potential for social disorder. there was a lack of clarity around community law on implementation of travel restrictions, and some confusion regarding the extent to which issues of freedom of mobility needed to be handled differently according to an individual's nationality. to be practical and costeffective, border measures would require policy coordination between countries of arrival and departure, and consensus between neighbouring states to avoid disruption. however, as mounier-jack and coker note, few countries address the issue of collaboration with neighbouring states on matters of travel restrictions in their plans: ' there is clearly a need for countries within a european region to be informed and to inform others of their respective strategies in order to ensure that policies are consistent where necessary, or pose as few challenges as possible to public health protection where differences or inconsistencies exist. there may also be a need to ensure that european response mechanisms work together in harmony if public health interventions are to be similar in different countries'. national generic plans in europe have addressed issues of border control rather inadequately. questions have been raised about mobile populations and their implications for healthcare resources, but the issues remain unresolved. there appears to be political reluctance in the context of a united europe to invoke exemptions from internal market rules of free movement of goods and persons on grounds that neighbouring states are failing to address public health threats, and while there is concern about the consequent risk to populations, most states have taken the pragmatic view that any border control should take place at europe's external borders and not within europe. the variation in public health resources and in public health legal powers across eu states, in a context of free borders, is a concern for europe-wide pandemic disease strategies. it is not impossible that states with the strongest national public health powers, which permit, for example, compulsory vaccination or detention, will find some citizens moving states to avoid imposition of these powers. ideally, states within the eu will work together to achieve some commonality of pandemic disease policy and some commonality in their public health legal frameworks. much has been done to develop common policy approaches to preparation for an influenza pandemic across europe. however, article of the european treaty, which states the eu objective of a high level of health protection and requires the european community to work with nation states to deal with health threats, does not allow for a policy of harmonization of state laws. the most that can be hoped for is some convergence of legal powers resulting from discussion and negotiation between states. the differing histories, politics, culture and legal systems of this group of highly divergent states does not bode well for agreement across europe on the appropriate legal response to disease threats. in an attempt to identify the extent to which there is variation in public health legal powers and the consequences of such variation for public health in europe, the phlawflu project is examining the role of national laws in the control of and protection against pandemic human influenza across europe. the objective of the project is to provide an evolving critical study of national laws supporting and constraining defined issues of communicable disease control across europe, and to provide a resource to support public health law reform and public health policy making in europe. the project methodology includes workshops bringing together public health policy makers from european states to examine legal responses to disease scenarios. it is to be hoped that some common legal responses emerge from these exercises, and given the absence of attention paid to public health laws in europe in recent years, that much can be learned by all states on ways in which to use law as a tool in pandemic disease control. meanwhile, europe is in a complex place in relation to its public health approach to pandemic disease. in times of economic strength and freedom from threats of war and disease, the commonality of eu states comes to the fore, and states are ready and willing to engage in joint enterprise. where states are at threat, however, they tend to turn inward on themselves, and political and cultural differences emerge. in times of threat, states which have traditionally been strong on public intervention in private rights are unwilling to accede to the approaches of more liberal states. traditionally, liberal states are reluctant to impose draconian measures, but at the same time may be unwilling to carry the public health burden of citizens from poorer states. the revised ihr have done much to focus public health law reform measures and to ensure some minimum commonality of content, but it is clear that some states, in accordance with their legal culture, are prepared to undertake more intrusive interventions than others. for all these concerns, it is clear that public health laws will be a mainstay of pandemic disease strategies, both in relation to the eu and in relation to nation states within europe. public health laws will be essential in providing powers to enable actions to be taken to control disease spread, but also to constrain states from taking actions that might reassure short-term security concerns but that have potentially harmful long-term public health consequences. of course, such issues are not unique to europe, but the nature of europe as a continent and as a legal entity creates particular complications for the ways in which law might best be used to create a coordinated european pandemic disease strategy. one unexpected benefit of the pandemic threat has been the renewed interest in exploring the role of law as a communicable disease tool, and in the examination of the range of public health legal approaches across europe. globally, a greater understanding of the role of public health law as a tool for managing and minimizing the spread of communicable disease will be a lasting and invaluable legacy of governance efforts in relation to pandemic influenza. none sought. none declared. european centre for disease prevention and control. technical report: pandemic influenza preparedness in the eu. status report as of autumn european public health law network website. available at: www.ephln.org social measures may control pandemic flu better than drugs and vaccine report on the influenza epidemic in nsw in world health organization writing group. nonpharmaceutical interventions for pandemic influenza, national and community measures the exercise of public health powers in an era of human rights: the particular problem of tuberculosis introduction. the importance of law for public health policy and practice public health powers in relation to tuberculosis in england and france: a comparison of approaches public health law and tuberculosis control in europe how prepared is europe for pandemic influenza? an analysis of national plans cabinet office and department of health. pandemic flu, a national framework for responding to an influenza pandemic. london: department of health pandemic flu, influenza pandemic contingency planning: operational guidance for health service planners. london: department of health ministry of social affairs and health. finnish national preparedness plan for pandemic influenza; proposal of the working group on national pandemic preparedness. helsinki: ministry of social affairs and health uk international priorities: a strategy for the fco. cmnd . london: hmso the limits of law in the protection of public health and the role of public health ethics quarantine and prevention of disease ordinance the exercise of public health powers in cases of infectious disease: human rights implications a v secretary of state for the home department a v secretary of state for the home department greek case, yb , opinion of the commission russian federation. ecthr judgment of european commission for democracy through law (venice commission) the interface between public emergency powers and international law the law of exception: a typology of emergency powers drafted by the centre for law and the public's health at georgetown and johns hopkins universities the model state emergency health powers act bioterrorism, public health and civil liberties public-private health law: multiple directions in public health global public health security health, security and foreign policy public health strategies for pandemic influenza: ethics and the law health and human rights: a reader human rights and the new public health human mobility and population health increasing drug resistant tuberculosis in the uk compulsory screening of immigrants for tuberculosis and hiv world health organization. ethical considerations in developing a public health response to pandemic influenza directive / /ec of the european parliament and of the council of mapping schengenland: denaturalizing the border health-care system frailties and public health control of communicable disease on the european union's new eastern border world health organization pandemic phases exercise common ground: a pandemic influenza exercise of the european union department of health and cabinet office. pandemic influenza -sharing of evidence and response policies across the eu. london: department of health workshops and facilitated by dr miguel betancourt cravioto and dr daniel reynders physical interventions to interrupt or reduce the spread of respiratory diseases: a systematic review specifications attached to the invitation to tender document, sanco/c / / , quoted in health protection agency, exercise common ground, a pandemic influenza exercise for the european union, final report. london: health protection agency none declared. key: cord- -d wt dqp authors: seng, j. j. b.; yeam, c. t.; huang, w. c.; tan, n. c.; low, l. l. title: pandemic related health literacy - a systematic review of literature in covid- , sars and mers pandemics date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: d wt dqp background: health literacy plays an essential role in ones ability to acquire and understand critical medical information in the covid- infodemic and other pandemics. purpose: to summarize the assessment, levels and determinants of pandemic related health literacy and its associated clinical outcomes. data sources: medline, embase, psychinfo, cinahl, arxiv, biorxiv, medrxiv, and social science research network. the start date was unrestricted and current as of april . study selection studies which evaluated health literacy related to novel coronavirus disease (covid- ), severe acute respiratory syndrome (sars) or middle east respiratory syndrome (mers) data extraction data on the characteristics of study designs, instruments, participants and level of health literacy were collected. items used in instruments were grouped under the themes of knowledge, attitudes and practices. determinants of health literacy were grouped into five domains (socio-demographic, medical, psychological/psychiatric, health systems related and others). data synthesis: of , articles screened, articles were included. , and studies evaluated health literacy related to covid- , sars and mers, respectively. the rates of low pandemic health literacy ranged from . to . % among medical-related populations and . % to . % among non-medical populations. knowledge about symptoms and transmission of infection; worry about infection and, practices related to mask usage and hand hygiene was most frequently evaluated. socio-demographic determinants of health literacy were most studied, where higher education level, older age and female gender were associated with better health literacy. no studies evaluated outcomes associated with health literacy. limitations non-english articles were excluded. conclusion: the level of pandemic related health literacy is sub-optimal. healthcare administrators need to be aware of health literacy determinants when formulating policies in pandemics. with the rapid progression of the novel coronavirus disease (covid- ) into a pandemic infecting over . million patients worldwide, the need to gather and synthesize health-related information to make timely behaviour changes among people has become quintessential. ( , ) this comes in the wake of an "infodemic" with evolving scientific knowledge about infections being generated daily, which has led to reversals in infection prevention recommendations made within a short span of time. ( ) ( ) ( ) for example, the use of cloth masks during the early stages of the covid- pandemic was discouraged by the world health organisation due to uncertainty about its efficacy. ( ) however, its potential use in slowing the spread of covid- has led to subsequent recommendations by the us centers for disease control and prevention for it to be worn by healthy individuals. ( ) the ease of access to information via social and online media platforms has also become a double-edged sword in this pandemic where there has been substantial propagation of misinformation. ( ) faced with the continuous influx of information related to this pandemic, an individual's level of health literacy exerts a vital role in one's ability to acquire, discern and understand accurate medical information. health literacy is broadly defined as the "level of capacity one has to obtain, process and understand basic health information and services needed to make appropriate health decisions." europe where % of the population were shown to have limited health literacy. ( ) in the setting of non-communicable diseases, the association between health literacy with increased healthcare costs, morbidity and mortality is well-established. ( ) the equal importance of health literacy in communicable diseases was highlighted in the recent covid- crisis and previous coronavirus pandemics such as the severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers). ( , ) in contrast to general health literacy required for the prevention or management of chronic diseases, these pandemics require an individual's readiness and adaptive ability in developing their pandemic related and critical health literacy quickly. this is critical as the rapid and successful implementation of infectious diseases control measures requires the collective compliance of all individuals. ( , ) network (ssrn) were extracted for evaluation. keywords employed in the search strategy included terms related to health literacy as well as the viruses and syndromes implicated in the three coronavirus pandemics which were namely covid- , mers and sars. terms related to health literacy were adapted from reviews which evaluated health literacy in other patient populations. ( , ) the full search strategy was detailed in supplementary file . the start date of the search was unrestricted and current as of april . full-text articles, both peer-reviewed and non-peer reviewed in the english language were retrieved from the eight databases. studies which evaluated health literacy related to covid- , sars or mers among adult participants aged ≥ years old from the general population, healthcare sectors and infected patients were included. for the study designs, both interventional and observational studies such as cohort, cross sectional and case control studies were included. case series, case reports, other irrelevant meta-analyses and systematic reviews were excluded. we also excluded studies which evaluated paediatric populations and non-human subjects. two independent reviewers (jjb seng and ct yeam) performed the screening and inclusion of articles. all disagreements encountered during the review process were discussed. in situations where the disagreements could not be resolved, a third independent reviewer (cwh huang) arbitrated to achieve consensus. data extracted included the socio-demographic and clinical characteristics of the study participants such as their age, race/ethnicity, education levels, income levels, study designs, instruments used for assessment of health literacy, the definition of health literacy used in studies, level of health literacy, factors associated with health literacy and clinical outcomes associated with health literacy. for the risk of bias assessment, the quality assessment tool for studies by national health, lung and blood institute was adopted to evaluate the methodological quality of included articles.( ) each study is rated as low, moderate and high risk of bias by the two independent reviewers (jjb seng and ct yeam) based on the responses obtained from the ten items. in situations where insufficient information was available to score an item, the authors of the study were contacted for clarification. if the authors could not be contacted, the item was rated as high risk of bias. all disagreements were resolved via discussion between the two reviewers. only studies which were rated as low and moderate risk of bias were included in this review. descriptive statistics were used to summarize the characteristics of included studies. with regards to the level of health literacy, we reported the average percentage of correct answers or the percentage of participants with low health literacy as defined by cut-offs described in each study, where available. as there are no gold-standard health literacy instruments developed for covid- , sars or mers( ), significant heterogeneity is expected in the types of tools used for assessment of health literacy across participants. consequently, meta-analysis could not be performed. questions from instruments used across included studies were classified into three main themes, which were ) knowledge, ) attitudes and ) practices, to help guide future development of standardised covid- and pandemic health literacy tools. the analyses were segregated by medical and non-medical populations due to the expected differing levels of health literacy in the two populations. for studies where the questionnaires were not available, study authors were contacted for the questionnaire. if there were no replies from the authors, the themes were extracted from the description of the questionnaires in the main text. a framework for core items to be included in pandemic health literacy tools was also proposed based on common themes assessed across studies. for factors associated with better health literacy, they were categorized into five domains which encompassed socio-demographic, medical, psychological/psychiatric, health systems related and others. a narrative review was provided for the factors evaluated among included studies. clinical outcomes associated with poor health literacy among patients infected with covid- , mers and sars included time from illness onset to seeking medical treatment, hospitalisation and duration of hospitalisation, admission to intensive care units and length of icu stay, need for ventilator support, recovery from infection and re-infection. this study was not funded by any organisation. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint figure shows the flowchart for the inclusion of articles. a total of , published articles and pre-prints were retrieved. after removal of duplicates, exclusion of irrelevant articles and inclusion of articles identified from hand-searching, a total of articles were included in this review. the percentage of concordance during the initial article screening was %. details pertaining to the study designs and characteristics of participants among included studies were reported in supplementary file . for the risk of bias, ( . %) and ( . %) studies were rated as low and moderate risk of bias. no studies were rated as high risk of bias (supplementary file ). table shows a summary of the characteristics of the included studies. majority of included studies were cross-sectional in design (n= , . %) and were conducted during the pandemics (n= , . %). ( %) studies recruited more than participants. a total of ( . %) studies examined health literacy related to covid- ( table ) . majority of the studies were conducted in asia ( . %) and north america ( . %). most studies were conducted among the general population (n= , . %). the primary mode of health literacy assessment across studies was via online questionnaires (n= , . %). aspects of health literacy that were assessed in the instruments included knowledge (n= , . %), attitudes (n= , %) and practices (n= , . %), of which only ( . %) studies performed validation of their questionnaire. most questionnaires (n= , . %) contained - items. pertaining to health literacy, the average percentage of correct answers among medical personnel ranged from . to . %, and low health literacy was reported among . table ) . majority of studies were mostly performed in asia ( . %), europe ( . %) and north america ( . %). the most common groups of study participants included the general population (n= , . %) and healthcare professionals (n= , . %). for the assessment of health literacy, these were conducted primarily via . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , among the pandemics, the most number of studies examined health literacy related to mers (n= , . %) ( table ). the studies were mostly conducted in asia (n= , . %) and europe (n= , . %) where the majority of them were conducted in saudi arabia (n= , . %). the most common group of participants recruited comprised of healthcare professionals (n= , . %) and medical students among the three themes, pandemic related knowledge was most studied, followed by practices and attitudes (tables - ). in the knowledge domain, symptoms ( , , , , transmission ( , , , , - , - , - , , , - , - ) and incubation period of the virus ( , , - , , , , , , - , - , - , - , ) ; management and treatment options ( , , - , , , , , - , , - , , , , , , , - , , ) ; and clinical outcomes associated with infection ( , , - , , , , , , , - , , , , , - , , - , - ) ; high risk populations for infection ( , , , , , , - , , , - . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . , , , , , , , ) ; availability of vaccine ( , , , , , - , , , , , , - , , , , - , ); role of hand hygiene ( , , , , , , , , , , , , , - , , , , - , , ) was most studied for medical and non-medical staff. (table ) for medical related populations specifically, knowledge about epidemiology ( , , , , , , , , - , , , , ) and diagnosis of infection ( , , , , , , - , , ) were also frequently evaluated. for attitudes about pandemics, worry/fear/helplessness about pandemic ( , , , , , , , , , , , , , , , - , , , ) , confidence in governments' ability to manage pandemic ( , , , , , , , , , , , , , ) and perceived severity of infection as a public health problem ( , , , , , , , , , ) was most commonly assessed. (table ) for practices in pandemics, behaviours related to mask utilization ( , , , , , , , , , , , , , , , , , , , , ( ) ( ) ( ) , hand hygiene ( , , , , , , , , , , - , , , , , , , ) , personal hygiene ( , , , , , , , , , , , , , , , , ( ) ( ) ( ) and information seeking ( , , - , , , , , , - , - , , , , , , , , , , , , , ) were most commonly studied. (table ) figure shows the proposed framework (pandemic-hl) for items to be included in generic pandemic health literacy tools. across the five domains for health literacy related factors, factors were identified. (table ) among these, socio-demographic-economic and health systems-based domains were the most studied. sociodemographic factors which were commonly associated with better health literacy included higher educational level ( , , , , , , , , , , , , - , - , , ) , increased age ( , , , , , , , , , , , , , , , ) and female gender ( , , , , , , , , , , , , , , , , , , , , ) . for health systems-based factors, increased experience in the healthcare system ( , , , , , ) and attendance in health education programs ( , , , , , ) were associated with better health literacy. for medical and psychiatric/psychological factors, increased general health literacy ( , ) and increased anxiety about the spread of infection ( , , , ) were associated with better health literacy. lastly, other factors associated with better health literacy included the use of traditional sources of information such as newspaper or television ( , , ) . among the included studies, no studies evaluated clinical outcomes related to covid- , sars or mers. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint for populations at increased risk of poor clinical outcomes of infections such as the elderly, immunocompromised patients, human-immunodeficiency virus or with multiple comorbidities, they form high priority populations where the levels of pandemic health literacy should be assessed. ( , ) in the context of the current covid- pandemic, our review only found study which specifically evaluated the health literacy related to covid- among these high-risk populations. ( ) it is imperative that future research is undertaken to evaluate the health literacy among these patient populations for targeted interventions to be designed for patients if required. significant heterogeneity in the instruments used for the assessment of pandemic related health literacy was noted in our review. currently, there is no gold-standard instrument which evaluates pandemicrelated health literacy. given the need for validated and standardised tools to be created to facilitate the evaluation of pandemic related health literacy, the pandemic-hl framework was proposed to guide the selection of topics to be addressed in instruments. it was modelled after psychosocial models of health behaviours and encompassed key topics which were frequently evaluated in instruments across the three pandemics. ( ) it is hoped that the framework will serve as a foundation for facilitating the development of health literacy tools for future pandemics. is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint this may limit the generalizability of the study results. ( ) additionally, the validity of these study results may be affected as these surveys commonly suffer from poor response rates. ( ) with regards to the determinants of pandemic related health-literacy, higher education levels, older age, female gender, and being employed were the most studied factors associated with higher pandemic . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . the main strength of this review was that health literacy in previous coronaviruses related pandemics such as sars and mers were evaluated to provide a more comprehensive overview of pandemic related health literacy. however, the findings from this review should also be interpreted with the following limitations. firstly, while we adopted a reasonably comprehensive search strategy, potentially relevant articles may have been missed. finger searching within the references of included articles was performed to minimize this omission of potentially relevant articles. secondly, we were only able to include articles in the english language due to the language limitations of the authors. thirdly, we were not able to perform meta-analyses for the overall level of pandemic related health literacy and their determinants due to the heterogeneity in instruments. with the development of a standardised instrument for the assessment of health literacy related to pandemics, future studies should consider using meta-analyses to compare the level of health literacy across different populations. lastly, the full questionnaires could not be accessed for studies. while themes described in the main text of these articles were carefully extracted, we could not rule out the omission of themes which were not described. future health literacy studies should append their questionnaires to allow meaningful evaluation of the study results. overall, the level of pandemic related health literacy remains sub-optimal among both the medical and non-medical population. this is worrisome given the critical role health literacy serves in reducing the spread of contagion and mitigating the effects of pandemics. there is an urgent need to develop up-todate, validated and standardised questionnaires for the rapid assessment of pandemic-related health literacy. important determinants associated with better levels of health literacy such as older age, female gender, employment status and education level were highlighted in this review. healthcare administrators and policymakers need to be mindful of these determinants when formulating dissemination of critical pandemic related information and interventions to improve the health literacy of the population. more studies are required to evaluate the clinical outcomes associated with pandemic related health literacy. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . jjb seng was the study's principal investigator and was responsible for the conception, initial literature review and design of the study. ct yeam, cw huang, nc tan and ll low were the co-investigators. jjb seng, ct yeam and cw huang were responsible for the screening and inclusion of articles and data extraction. all authors contributed to the data analyses and interpretation of data. jjb seng prepared the initial draft of the manuscript. all authors revised the draft critically for important intellectual content and agreed to the final submission. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . . it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . definitions of terms used in precautionary measures e.g. "safe distance", "close contacts", " transient contacts" is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . control measures implemented by government e.g. restriction of travel to china repercussions associated with non-compliance with measures implemented by government or authorise control measures implemented by healthcare institutions it is made available under a 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study and takes responsibility for the integrity of the data and the accuracy of the data analysis. key: cord- -nhnhst f authors: morgan, randall c.; reid, tiffany n. title: on answering the call to action for covid- : continuing a bold legacy of health advocacy date: - - journal: j natl med assoc doi: . /j.jnma. . . sha: doc_id: cord_uid: nhnhst f the indelible impacts on our nation from the coronavirus pandemic along with high fatality rates that disproportionately burden racial and ethnic minorities necessitate long-term coordinated federal, state and local action to improve critical determinants of population health, specifically important health and public health infrastructures as well as emergency and disaster preparedness systems. while our purview as the new pandemic epicenter should be a sufficient driver, coordinated health professionals bringing thoughtful attention to our historical context may be warranted. prompting our advocacy should be the reality that our collective ability to rebound from such crises may ultimately hinge on protecting and equipping our most vulnerable racial-ethnic minority groups and any susceptible individuals within those populations. recent historic firsts on behalf of racial and ethnic minorities taken by u.s. department of health and human services, through the health resources and services administration, the office of minority health and the centers for disease control and prevention in response to covid- , if proven effective, should be considered for permanency within policy, practice and funding. in addition, given the complex history of black americans in this country and persistent and substantial black-white disparities on health and economic measures across the board, the ultimate solution for improving the health and status black americans may look slightly different. influenced by the th year anniversary of the first documented arrival of unfree africans in north america in , as well as the introduction of bills s. and h.r. into congress (the commission to study and develop reparation proposals for african-americans act), some kind of reparations for black americans might serve as the logical starting point for further advocacy. nevertheless, we remain supportive allies of all organizations concerned with communities who suffer the weight of this pandemic and any future world health disasters. what is additionally needed is a thoughtful unification of efforts and a commitment to sustained progress with measurable results for as long as the need exists and certainly for the foreseeable future. let us as humane clinicians and public health professionals capture this moment of challenge and follow through on this urgent call to action. a ll leading professional medical organizations and associations in the united states and especially those related to public health should feel secure taking bold action to measurably advance health equity within our country amid the current pandemic due to the virus that causes covid- . prompting our efforts should be the reality that our collective ability as a nation to rebound from the coronavirus' devastation may ultimately hinge on protecting and equipping our most vulnerable racial-ethnic minority groups and any susceptible individuals within those populations. azar ii, j.d., have acknowledged as "unacceptable" the conditions underlying longstanding health disparities that remain unaddressed while they place some communities at disproportionate risk for death and disability from the coronavirus. , however, only thoughtful attention to our historical context as we develop tailored, group-specific measures and interventions will help us effect larger improvements in critical determinants of population health. federal coordination of response strategies and recovery from this pandemic that can be tailored and implemented locally may also be necessary. an added benefit will be the overall strengthening of health and public health infrastructures as well as the advancement of our emergency and disaster preparedness systems. we are seeing conclusive evidence that a powerful collective advocacy bringinh that kind of thoughtful and deliberate intent can effectively sway action of the federal government as it relates to health crises like the current pandemic, which is deeply encouraging. in early april , a washington post analysis of nine counties showed that majority-black have three times the rate of infections and almost six times the rate of deaths as counties where white residents are in the majority, noting that only a few jurisdictions publicly report coronavirus cases and deaths by race. additionally, a letter from the lawyers' committee for civil rights under law as well as an appeal from several national physician organizations formally called upon hhs secretary azar to direct federal agencies to collect and release information including statistics by race and ethnicity when reporting on impact and case fatality due to coronavirus. , by the end of that same month the centers for disease control and prevention (cdc) published a morbidity and mortality weekly report (mmwr) containing some of that information as available from hospitalization records. influenced by the th year anniversary in of the first documented arrival of unfree africans in north america in , [ ] [ ] [ ] [ ] as well as the introduction of the bill s. -hr into congress (the commission to study and develop reparation proposals for african-americans act), , we strongly urge that some kind of reparations for black americans serve as the logical starting point for further advocacy. informing our assertion of an approach that could be perceived radical by some is the national medical association's (nma's) long history of advocacy within health and medicine as well as throughout the nation whenever the cause was about fairness and equity for all, even when seemingly at odds with mainstream culture at the time. we are further emboldened by the knowledge that former nma president and naacp president, dr. william montague cobb, for whom the w. montague cobb/nma health institute (cobb institute) is named, helped orchestrate the national hospital desegregation movement as well as championed passage of the civil rights act in and medicare in . the current coronavirus pandemic has been uniquely devastating and without recent precedent as a whole for the u.s, the new epicenter for the outbreak. while other similar global occurrences created action abroad, they usually created little panic at home given their smaller scale and relatively limited geographical spread. (the occurrences of ebola hemorrhagic disease, severe acute respiratory syndrome (sars), h n (also called swine flu) and zika virus disease are examples). reports show that as of end of may, the virus has been detected in nearly countries, resulting in the infection of . million persons and more than , deaths, the most of which have occurred in the u.s. now approaching , coronavirus infections in the u.s., just over four months after the first known case was confirmed, the number of coronavirus-related deaths in the u.s. has reached more than , . unfortunately, identification of a vaccine against coronavirus is predicted to take over one year at the least. some noted potential challenges for vaccine development are as follows : antigen design for optimal immune response ; potential exacerbation of lung disease, either directly or as a result of antibody-dependent enhancement; and duration of immunity from single-dose vaccines. furthermore, the virus' aggressive, highly transmittable behavior, lethality and distribution in the population is not fully understood by scientists and clinicians. inconveniently timed for all of our communities for a variety of reasons, the coronavirus outbreak occurred swiftly and pervasively across the country with unexpected impact and with high fatality rates. the observed lack of coordinated testing capability and emergency preparedness and response systems were predicted, given insufficient integration of our healthcare and public health infrastructures coupled with the social determinants of health yet to be at the forefront of our governmental decisionmaking process. great geopolitical divides and broad distrust with the u.s. also continue to delay and hamper a coordinated emergency response at the federal, state and local levels. the immense burdens placed on the most vulnerable racial and ethnic groups complicate this picture to a greater extent, as revealed by relevant epidemiologic data. growing evidence indicates excessively high rates of death and disability due to coronavirus for black american communities and other racial-ethnic minorities, and at alarmingly disproportionate levels given similar transmission rates across populations and our significantly smaller representation in the general population as a whole. along with older age and underlying health conditions such as cardiovascular disease or pulmonary conditions, certain environmental exposures and other factors such as nutritional status may heighten that risk. [ ] [ ] [ ] [ ] in fact, the impact and fatality rate from this virus may likely correlate most closely with vulnerable groups and even more so with biologically susceptible individuals within those populations. collection of additional data on the demographics of covid- infected individuals as well as wider availability of testing for viral infection are needed to mitigate this disparate impact. the full extent of the economic and other tolls from the coronavirus are still uncertain but may likely mirror the distribution of the human tragedy once better documented. in addition, even though pandemic-related preparation and planning have regularly occurred in u.s. public health circles since the influenza pandemic, interventions accepted as public health standards historically lack scope and vision when applied to vulnerable racial-ethnic minorities. plans to address public health emergencies like an epidemic may be drafted and possibly rehearsed for the public are seldomly written with attention to the complexity of the needs and barriers for specific populations. nor do comprehensive plans, preparations, or budgetary set asides when implemented transfer well between government administrations, whether they be congressional, presidential, state-level, county-level or local governmental transitions even in the presence of admirable leadership in this area. now that we are beginning to observe federal agencies more readily heeding the plight of vulnerable groups and populations under the current crisis, we hope that these historic interventions, if proven effective, can be made permanent within policy, practice and funding as they relate to racial and ethnic minorities. in early april, the u.s. department of health and human services (hhs), through the human resources and services administration (hrsa) awarded $ . billion to federally qualified health centers (fqhcs) to support their ability to detect, prevent, diagnose, and treat covid- as well as maintain or increase health center capacity and staff. "health centers deliver care to the nation's most vulnerable individuals and families, including people experiencing homelessness, agricultural workers, residents of public housing, and our nation's veterans. led by patient-majority boards, these health centers provide affordable, accessible, and quality primary health care to over million people a year, regardless of their ability to pay." also notable is that hhs' office of minority health (omh) in early may released a competitive funding opportunity to support linkages to services, information and education around covid- for minority, rural and socially vulnerable communities called the national infrastructure for mitigating the impact of covid- within racial and ethnic minority communities initiative. the -year initiative seeks to develop and coordinate a strategic and structured information network of national, state/territorial/tribal and local public and community-based organizations who will mitigate the impacts by : improving the reach of covid- -related public health messaging ; increasing connection to healthcare and social services ; decreasing disparities in covid- testing and vaccination rates; and enhancing capacity and infrastructure to support response, recovery, and resilience. omh plans to fund one awardee for a period of up to years at $ million total. these efforts to stimulate solutions on the community level need to be multiplied to have the desired impact. the cdc is also undertaking laudable measures in response to covid- that speak to the needs of racial and ethnic minorities. noting that health differences between racial and ethnic groups are often due to economic and social conditions that differ from whites, they acknowledge in new recommendations and guidelines that living conditions, work circumstances, underlying health conditions and lower access to care, can affect their preparation and response to public health emergencies such as an influenza outbreak. [ ] [ ] [ ] thus, in response to the many challenges presented by the current coronavirus pandemic, the cdc is: collecting data to monitor and track disparities that will be used to improve the clinical management of patients, allocation of resources, and targeted public health information. supporting partnerships between scientific researchers, professional organizations, community organizations, and community members. providing clinical guidance and guidance to schools, workplaces and community settings. providing on its website, guidance documents to navigate the impact of covid- for individuals, families, healthcare systems and providers as well as public health professional. however, we hope that with input from hhs as well as the work of cdc and its grantees, regulations are issued to implement laws and develop policies and guidance for state and local governments, industry, and other organizations with attention to vulnerable communities. prior to these recent efforts, highly concerning to us was that even through , the hhs national pandemic influenza plans developed to prevent, control and mitigate the effects of influenza viruses fails to provide strategies for limiting or eliminating racial and ethnic disparities in vaccination, treatment access or contact tracing, although it does call for attention to vulnerable and at-risk individuals. if not already done so by the time of this article, that plan may need to be revisited and updated with the language of concern and guidance around reaching vulnerable racialethnic minority groups that is reflected in current funding hhs efforts. the language and intention of the guidance documents of the cdc under covid- should also be enshrined to inform actions for the long-term and not just under the current pandemic. as clinicians and public health practitioners we understand that best public health practice entails continuously targeting the most vulnerable groups and communities for chronic and infectious disease prevention, intervention, distribution of resources and financial support when there is economic disruption. doing so will only help assure preparedness for subsequent public health emergencies the gross disruptions that we are currently observing for vulnerable groups and communities. in addition to these generic and typical public health strategies, for black americans we strongly suggest that reparations may be the ultimate answer. note that whereas this particular solution centers on the history of black americans given our expertise on black-white disparities and informed by the work of the nma since its founding in , the cobb institute remains supportive allies for all concerned health professional organizations to focus upon all communities who suffer the weight of this pandemic and any future world health disasters. with this fact in mind, two logical questions appear worth asking u.s. society at large: how can dedicated government funds be allocated in the long term toward initiatives for populations in the u.s. whether rural or urban who because of structural and social determinants of health bear the greatest burden of death and disease from public health emergencies such as the covid- pandemic? given this pandemic's magnification of longstanding racial inequities in heath and healthcare in the u.s. that date back to slavery, would reparations of some kind to black americans be appropriate for correcting the foundational black-white racial inequalities in housing, working conditions, climate challenges and the lack of access to quality education that have created specific health-vulnerabilities to covid- ? we believe that significant, well-documented scholarship on black reparations warrants serious consideration. [ ] [ ] [ ] [ ] [ ] the long historical underpinnings exacerbating this crisis for black americans adds a strong moral imperative as well as a valid social justice claim. black americans, consisting of populations acknowledged as being present in the country since its founding, have made immeasurable contribution to the early, rapid development and subsequent central global economic positioning of the u.s. [ ] [ ] [ ] yet this group has also been marginalized historically and left economically and socially disadvantaged intergenerationally and with high, disproportionate health burdens overall. in fact, as we reflect on several solutions worthy of implementation offered by physicians and other colleagues serving on the frontline in vulnerable communities, [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] we submit that each proposal could be easily funded as part of a reparations package. already numerous calls by these health professionals for widespread, no-cost diagnostic testing and collection of demographic data on who is being affected are being appreciated. even hints of measures to address the broader inequities that drive current social and environmental conditions for health inequality are present in the latest efforts by hhs as well as its omh and the cdc. such efforts should be funded in the long term and with attention to a variety of conditions and illnesses. direct monetary compensation specifically designated for black americans given the economic consequences of racism and discrimination has also been mentioned and should be respected. every one of our allied professional organizations with a part of its mission and agenda to improve the health status of racial and ethnic minorities, including the national medical association (nma) and its many affiliates, the american medical association (ama), the national hispanic medical association (nhma) and the american public health association (apha) have all demanded action to address persistent inequities laid bare by the impact of covid- . the present, promising unity of purpose is deeply felt. what is additionally needed is a thoughtful unification of efforts of these and other like-minded organizations and a commitment to sustained progress with measurable results for as long as the need exists and certainly for the foreseeable future. however, we must be urged to use this tragic opportunity to set the stage for long-term disaster planning for socially vulnerable communities that are group-specific, which inevitably involves coordinated federal, state and local policies and efforts to tackle the existing structural and social determinants of health. ultimately, the benefits of this unified effort will influence the rest of our united states society to seek improvement of the health status and wellbeing of all. we are of the belief that now is not too late to save lives and halt the progression of this virus throughout the communities, both urban and rural, of our great nation. let us as humane physicians and public health professionals capture this moment of challenge and follow through on this critical call to action. covid- : black people and other minorities are hardest hit in us health issues that affect minority groups are making the pandemic worse, azar says we need one response d not d to fight covid- the coronavirus is infecting and killing black americans at an alarmingly high rate covid- : continuing a bold legacy of health advocacy committee for civil rights under law national medical association, national hispanic medical association, association of american indian physicians, and national council of asian pacific islander physicians hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease dcovid-net, states years of inequality since jamestown of years of african-american history commission act (hr ) the project years of inequality the power to heal: civil rights, medicare, and the struggle to transform america's health care system new york times the coronavirus outbreak live coverage developing covid- vaccines at pandemic speed covid- pm . , a national study on long-term exposure to air pollution and covid- mortality in the united-states air pollution and the novel covid- disease: a putative disease risk factor. sn comprehensive clinical medicine does air pollution influence covid- outbreaks? atmosphere nutrition support in the time of sars-cov- (covid- ) covid- funding available to minority, rural and socially vulnerable communities for linkages to services, information and education coronavirus disease (covid- ) racial & ethnic minority groups covid- ) guidance documents communication/guidance-list.html?sort=date% a% adesc cdc. coronavirus disease (covid- ) communities, schools & workplaces influenza (flu) national pandemic influenza plans the case for black reparations redress for historical injustices in the united states: on reparations for slavery, jim crow, and their legacies from here to equality: reparations for black americans in the twenty-first century. the university of the debt: what america owes to blacks the case for reparations slavery's capitalism: a new history of american economic development american slavery, american freedom the business of slavery and the rise of american capitalism how covid- is the perfect storm for black americans commentary: why so many black americans are dying from covid- and how to make health care equitable address african-american residents' heightened risks of the coronavirus will we be able to say the same about the racism it has illuminated must avoid building racial bias into covid- emergency guidance black medical leaders: coronavirus magnifies racial inequities, with deadly consequences as a doctor, how do i tell a black family of five, struck by the virus, to 'social distance' in a two-bedroom apartment more minority physicians are key to eliminating health disparities the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. key: cord- -el rembl authors: dantés, héctor gómez; manrique-saide, pablo; vazquez-prokopec, gonzalo; morales, fabian correa; siqueira, joão bosco; pimenta, fabiano; coelho, giovanini; bezerra, haroldo title: prevention and control of aedes transmitted infections in the post-pandemic scenario of covid- : challenges and opportunities for the region of the americas date: - - journal: mem inst oswaldo cruz doi: . / - sha: doc_id: cord_uid: el rembl the coronavirus disease of (covid- ) pandemic challenges public health systems around the world. tropical countries will face complex epidemiological scenarios involving the simultaneous transmission of severe acute respiratory syndrome coronavirus (sars-cov- ) with viruses transmitted by aedes aegypti. the occurrence of arboviral diseases with covid- in the latin america and the caribbean (lac) region presents challenges and opportunities for strengthening health services, surveillance and control programs. financing of training, equipment and reconversion of hospital spaces will have a negative effect on already the limited resource directed to the health sector. the strengthening of the diagnostic infrastructure reappears as an opportunity for the national reference laboratories. sharing of epidemiological information for the modeling of epidemiological scenarios allows collaboration between health, academic and scientific institutions. the fear of contagion by covid- is constraining people with arboviral diseases to search for care which can lead to an increase in serious cases and could disrupt the operation of vector-control programs due to the reluctance of residents to open their doors to health personnel. promoting intense community participation along with the incorporation of long lasting innovations in vector control offers new opportunities for control. the covid- pandemic offers challenges and opportunities that must provoke positive behavioral changes and encourage more permanent self-care actions. since the identification of the new coronavirus (severe acute respiratory syndrome coronavirus -sars-cov- ) and associated disease (coronavirus disease of -covid- ) in january in china, the virus has spread to all continents and the world health organization (who) has reported more than . million infections and . thousand deaths (as of may ). ( , ) unprecedented measures to contain the pandemic and the response of the health systems are being implemented by the countries with a primary focus at the national level. at the local level, hand washing, respiratory hygiene recommendations, and physical distancing are key practices for disease containment, mitigation and suppression. the closing of the borders and social events in urban spaces have also contributed to mitigate the transmission, ( ) although its implementation has been very heterogeneous in each of the affected countries. there is discrepancy between predictive models of covid- behavior; some estimate a significant decrease in transmission between june and september, and on the contrary, additional transmission waves are also forecasted for the second semester of . ( , ) the high occurrence of covid- in tropical cities of latin america ( ) reflects the heterogeneous response of political leaders and the national capacity of public health systems in those countries. the transitions will thus vary accordingly from country to country. ( ) the unexpected expenditures disbursed to implement the prevention and control measures of covid- has put countries in a crisis that will affect not only economic activities but also the regular financing of routine preventive and control programs. we identify that this will be an additional challenge for the health systems and the economy of the countries of latin america and the caribbean (lac). contrary to what will happen in temperate countries, a large population contingent from tropical countries will experience complex epidemiological scenarios that will involve the simultaneous or intercalated transmission of sars-cov- with viruses of dengue, zika and chikungunya transmitted by aedes aegypti (atds). ( , ) another notable aspect is the potential exhaustion of the surveillance systems to investigate and report arboviral cases in a timely manner. in march , the pan american health organization (paho) issued an alert calling attention to the trend of increasing dengue cases in at least countries of the region compared to . ( ) dengue data obtained from health information platform for the americas (plisa) show that weekly dengue cases during were reported on a higher rate than the weekly average of dengue cases reported during the - period, and a sharp decrease in notification of confirmed dengue cases started along with the report of covid- cases in the lac region ( ) (figure) . the decrease in notification was particularly remarkable for south and central america. despite having limited information on the direct impact on human health of the interaction of arboviral diseases with covid- , ( ) it is essential that all efforts be made to protect populations at risk ( ) since aedes-transmitted diseases (atds) mainly affect vulnerable populations living in poor urban or rural areas and in houses with limited access to sewerage and drinking water services. ( , ) the indirect impact of covid- on arboviral diseases may be even greater than the direct one. health seeking behavior has been dramatically modified by covid- , driven by fear of contagion in the population, but also by messages from the health care authorities who recommend staying at home until severe symptoms (breathing problems) develop. in contrast, dengue cases are encouraged to present to health care units for close and early clinical monitoring (i.e., daily hematocrit). clinical management and rapid diagnosis of both diseases in the context of appropriate health facility triage and case management must be developed. for example, maintaining separate care facilities when possible for co-vid- and arboviral diseases is highly recommended. on the other hand, the fear of covid- contagion could also disrupt the operation of vector-control programs. residents may be reluctant to open their doors to health personnel and health brigades may not want to visit sars-cov- high risk areas because of lack of personal protection equipment and potential exposure to the virus. the evaluation of peridomestic settings arises as an alternative by vector control managers but avoiding the interaction with the community. challenges and opportunities -the simultaneous occurrence of aedes-transmitted diseases and covid- in the lac region presents us with very important challenges but also offers opportunities for strengthening health services, surveillance and control of epidemics (table) . the main challenge or obstacle, without a doubt, will be the economic crisis of the countries along with the reorganization of health services disrupted by the health emergency that diverted attention to the diagnosis and care of patients with severe respiratory manifestations. the reorganization of health services and the conversion of hospital spaces to contain the burden of disease caused by covid- has been detrimental to the care of other problems that are equally relevant and demanding in terms of the daily demand for specialized medical services. a similar experience occurred with reproductive, maternal, and child health services during the recent zika epidemic in the americas, and it may well happen again in the future with the resurgence of covid- or any other epidemic of global proportions. lessons learned from these experiences should help us prepare for future health contingencies. particular attention should be put in sustainability of interventions along with gender issues regarding risk of transmission, health care options and control responsibilities in the domestic and urban settings. ( ) financing of training, equipment and reconversion of hospital spaces will have a negative effect on already the limited resources directed to the health sector at the continental level. the indirect impact on health in general will be a collateral cost that will have to be evaluated in due course. there will be countries in the americas that can face this challenge better than others but the countries of the region have been hit by other epidemics without managing to recover financially from recurring health crises: cholera, h n influenza, zika, chikungunya or dengue. for the epidemiological surveillance systems there are challenges and opportunities given the possible seasonal coincidence of transmission, since the triggering signs and symptoms of seeking medical attention in the covid- charts, are fever, general malaise and respiratory discomfort also frequent in arboviruses. the high occurrence of covid- in tropical cities (e.g., iquitos, peru) indicates that temperature may not be as limiting for transmission as some hypothesize, however, the differential diagnosis of dengue, zika and chikungunya will need to incorporate covid- as a diagnostic possibility, although its confirmation triggers very different control actions. the strengthening of the diagnostic infrastructure reappears as an opportunity to prepare the capacity of the regional, nation and state reference laboratories to diagnose a very wide spectrum of infections agents for which the technical inputs, equipment or trained personnel are not available. thus, interaction between academic and public health institutions is mandatory as the pandemic has demonstrated. similarly, proliferation and real-time virtual epidemiological information platforms developed to monitor the pandemic must be available to monitor arboviral diseases and other infectious diseases with the same intensity and frequency with which they have been occurring in mapping the progress of the covid- pandemic. the effort to share and integrate epidemiological information sources for the construction and modeling of epidemiological scenarios becomes an imperative for regional health that allows collaboration between health entities with academic and scientific institutions. examples of such synergy include timely situational analysis, the generation of adequate risk scenarios for the design and selection of more effective control interventions as well as the use of information for education and communication campaigns with the population. an area of opportunity would be the incorporation of communication technologies (tics) in the test and tracing of contacts as well as mobility surveys in support of the early warning surveillance systems. traditionally, the countries of the american region based their control activities with the involvement of the community for the removal and control of domestic larval habitats the development of protective kits or tools so family members can perform the application of insecticide by themselves (spatial repellents, spray bombs) and the free distribution or purchase by the family of appropriate consumer products like spatial repellents, insecticide treated materials, or screens on doors and windows are interventions that should be encouraged and tested on a wider scale. given the new circumstances, home visits could be interrupted by physical distancing and it is essential to start incorporating new control strategies that do not depend so much on home visits by health personnel and are better supported by the promotion of domiciliary interventions that may be developed inside the house by the family nucleus. an additional opportunity is the more efficient use of resources that is based on risk stratification targeting areas in urban settings that are responsible for more than % of historical cases. ( ) in the case of aedes aegypti surveillance and control, the possibility is opened for promoting the incorporation of innovations that do not require and/or can reduce the constant presence of health personnel. ( ) for vector surveillance, the use of rapid larval/pupal surveys or the use of ovitraps in the peridomestic environment with the support of the community could be implemented to improve monitoring of vector densities while the proactive use of targeted indoor residual spraying (tirs) ( ) and contact tracing, ( ) for example, would favor a more extensive and long-lasting control. this paradigm shift becomes imperative and countries in the region have already drawn up action plans for the concurrence of co-vid- and atds. ( , ) of course, the nature of atds will also require action in response to outbreaks. the responsive actions are well-known in each country and must be carried out in a timely manner and have the human, consumables, and financial resources for it. recommendations established in the operational guides must be followed. chemical control (larvicides and adulticides) should be properly applied and selected based on evidence of susceptibility of the local vector populations to guarantee its effectiveness. in the field of risk communication, the covid- pandemic leaves us with lessons, challenges and opportunities that must lead to better information campaigns. risk communication strategies that increase positive behavioral changes that combat disinformation and encourage people to incorporate permanent self-care actions and not only in crisis situations. at the same time, the risks of transmission of covid- and its dispersion throughout the territory limit the full development of the activities that require the action of health agents, but it also creates a great opportunity to promote effective participation of population with the incorporation of protective habits of prevention and maintenance of the domestic environment free of risk factors for the presence of vectors. vector control personnel must be considered essential, and their activities must continue to support the actions required for the effective prevention and control of vtds, even within the contingency imposed by covid- . given the possible scenario of simultaneous transmission of the atds and covid- agents, it is important that the planning of the actions be integrated, combined with the effective multisectoral and population participation where the public and private sectors, schools, the media, tune into the common strategy to deal with health problems. recently, the countries of the region of the americas, with the support of the pan american health organization (paho), unanimously approved the plan of action on entomology and vector control - , ( ) whose objective is to strengthen regional and national capacity for prevention and control of key vectors, and reduce the spread of vector borne diseases (vbd). this plan of action is based on solid technical foundations that seek to strengthen inter-programmatic action, mobilize governments and communities, the improvement of entomological surveillance, the incorporation of new technologies, and the training, creation, and expansion the workforce. given the emergence of covid- , it is essential that countries commit to supporting this plan of action and strengthen their surveillance and control programs in an integrated way where new epidemiological circumstances are seen as challenges and opportunities and much less as disbeliefs or limitations. opportunities to improve control of atds will depend on how well we respond to the covid- crisis and even though the pandemic is still in progress, the challenges ahead demand resources and new capabilities not only to cope with covid- but to strengthen the overall capacity of the health system to respond to any new sanitary crisis. novel coronavirus ( -ncov) situation report - ; coronavirus disease (covid- ) situation report - impact of international travel and border control measures on the global spread of the novel coronavirus outbreak estimation of the probability of reinfection with covid- by the susceptible-exposed-infectious-removedundetectable-susceptible model projecting the transmission dynamics of sars-cov- through the postpandemic period situación de covid- en la región de las américas covid in latin america covid- and dengue fever: a dangerous combination for the health system in brazil covid- and dengue, co-epidemics in ecuador and other countries in latin america: pushing strained health care systems over the edge paho/who -pan american health organization/world health organization. epidemiological update: dengue american health organization. health information platform for the americas (plisa, paho/who), accessed on to alert coinfection of covid- and dengue virus in developing countries in the dengue-endemic area covid- and dengue, co-epidemics in ecuador and other countries in latin america: pushing strained health care systems over the edge the neglected tropical diseases of latin america and the caribbean: a review of disease burden and distribution and a roadmap for control and elimination economic impact of dengue illness in the americas gender mainstreaming as a pathway for sustainable arbovirus control in latin america technical document for the implementation of interventions based on generic operational scenarios for aedes aegypti control evaluación de las estrategias innovadoras para el control de aedes aegypti: desafíos para su introducción y evaluación del impacto manual para aplicar rociado residual intradomiciliario en zonas urbanas para el control de aedes aegypti combining contact tracing with targeted indoor residual spraying significantly reduces dengue transmission efficacy of novel indoor residual spraying methods targeting pyrethroid-resistant aedes aegypti within experimental houses estrategia de control de vectores en el escenario de transmisión simultánea dengue y covid- en méxico plan de acción sobre entomologia y control de vectores - [internet]. in: .º consejo directivo de la ops, .ª sesión del comité regional de la oms para las américas. del al de septiembre del key: cord- -iu dijsl authors: rosenstock, linda; helsing, karen; rimer, barbara k. title: public health education in the united states: then and now date: - - journal: public health rev doi: . /bf sha: doc_id: cord_uid: iu dijsl it was against a background of no formal career path for public health officers that, in , the seminal welch-rose report( ) outlined a system of public health education for the united states. the first schools of public health soon followed, but growth was slow, with only schools by . with organization and growing numbers, accreditation became an expectation. as the mission of public health has grown and achieved new urgency, schools have grown in number, depth and breadth. by mid- , there were accredited schools of public health, with more in the pipeline. while each has a unique character, they also must possess certain core characteristics to be accredited. over time, as schools developed, and concepts of public health expanded, so too did curricula and missions as well as types of people who were trained. in this review, we provide a brief summary of us public health education, with primary emphasis on professional public health schools. we also examine public health workforce needs and evaluate how education is evolving in the context of a growing maturity of the public health profession. we have not focused on programs (not schools) that offer public health degrees or on preventive medicine programs in schools of medicine, since schools of public health confer the majority of master’s and doctoral degrees. in the future, there likely will be even more inter-professional education, new disciplinary perspectives and changes in teaching and learning to meet the needs of millennial students. decades, tensions between the evolving fields of medicine and public health continued to be reflected in discussions about the future of public health. by the 's, growth in the number of sph had stalled (there were only by ), and economic challenges of schools were large, dominated by inadequate funding to pay faculty salaries, obtain necessary facilities and purchase needed equipment. schools increasingly turned to the national institutes of health (nih) for research funding. there was growing interest in building departments of preventive and community medicine within medical schools-many of these would prove forerunners of subsequent independent sph, but that future was uncertain and unplanned at the time. the first major government investment in public health education came in with the hill-rhodes bill which provided funds for training and project grants for public health. this was the beginning of a period of renewed interest in public health as applications to sph increased. schools began to thrive, with growth from sph in sph in to in . concomitant with the growth in independent public health schools were important changes in the numbers and composition of formally trained public health professionals. during the 's teaching methods changed, with greater attention to problem-based learning, especially in medical schools. support for public health professional education has been inconsistent over the decades, with a marked erosion of federal funding, beginning in the 's. this trend only reversed in the last few years but is again at risk in the wake of a serious recession. state government support also has been variable but significant; of the current schools are public institutions, with different levels of state assistance. most schools with state funding have seen that support eroded over the last few years, some very significantly. a recent article in the chronicle of higher education provided data about declines in state support for public universities. the average state cut was . percent, with at least four state cuts exceeding percent. today, sph train public health professionals at multiple levels, provide services to their local communities and beyond, and conduct research to prevent disease, disability and avoidable mortality at the individual, community and societal levels. schools also translate research into evidence-based policies and practices in communities, clinical care settings and governments, non-governmental organizations (ngos) and private organizations. research in sph ranges from basic laboratory research (e.g., to explain molecular signatures for particular viruses, cancers and other diseases) to applied research in communities as well as policy research. in fact, it is this continuum from basic research to translation of research into practice and policies that makes sph especially relevant and skilled in solving problems. public health researchers often collaborate with faculty in schools of medicine, pharmacy, dentistry, nursing, and others. they conduct bench and clinical research as well as communication research, comparative effectiveness studies, clinical effectiveness research and translational research, frequently with community-based research components. these varied roles reflect, in part, the fact that public health is not just a profession, but also a professional culture and commitment. sph educate undergraduate, master's, doctoral, postdoctoral, and certificate students. schools also provide continuing education to public health professionals within and beyond their geographic reach. the us centers for disease control and prevention (cdc) funds training centers within sph charged with developing leadership skills among certain groups of health professionals (e.g., those from underserved groups). similarly, the cdc has funded preparedness centers that focus on training particular kinds of professionals within assigned geographic regions. , this training and related concepts enabled schools to provide direct responses to training needs of first responders and health department personnel, in response to the events following september , and outbreaks such as severe acute respiratory syndrome (sars) and influenza a (h n ). since september , , public health students and many practitioners are trained to understand concepts and language of biosurveillance, health risk communication, and the critical roles government agencies and nongovernment partners play in responding to public health emergencies. the landmark institute of medicine (iom) report, the future of public health, criticized sph for being overly research intensive and disconnected from practice. in response, many schools made administrative and policy changes that institutionalized the means by which practice communities can access academic public health expertise and also increased opportunities for academicians to connect with communities. despite some successes in addressing acknowledged deficiencies in practice, there still are many challenges to create permeable boundaries between academic public health and practice. for example, the need to demonstrate publication productivity may cause many younger faculty members to choose professional focus areas that have quicker timelines to publication than those required to build relationships and consensus with practice communities. some schools have modified their appointments and promotion guidelines to reflect the importance of practice, but this varies from school to school. within sph, students pursue their education with an extraordinarily interdisciplinary range of faculty, including biomedical scientists, medical care professionals, behavioral and social scientists (e.g., economics, sociology, politics), epidemiologists, biostatisticians, information scientists, lawyers, health service researchers and health educators, among others. as a result, sph are well-positioned to be university leaders in collaborations with other schools, organizations and within the communities they serve. increasingly, there are collaborations with schools of journalism, social work, and regional and city planning. this reflects, in part, recognition of the complexity of health and healthcare and the forces that influence them. the association of schools of public health (asph) was founded in by a group of seven sph concerned about the growth of public health education programs. asph worked closely with apha to develop standards and definitions for sph. from to , apha conducted accreditation of graduate professional education in public health, at first centered almost exclusively in sph, but later including other college and university settings. in , the independent council on education for public health (ceph) was established by apha and asph. responsibility for evaluation of sph was transferred to ceph, which initially limited its focus to school accreditation. in the late s, ceph responded to requests from practitioners and educators to undertake accreditation of community health/ preventive medicine programs and to a request from apha to assume additional responsibility for community health education programs. in , these separate programmatic categories were combined into a single category of public health programs. ceph is the accrediting body for sph, but other organizations accredit particular programs within sph. these include the commission on accreditation for dietetics education (cade) and the commission on accreditation of health management education (cahme). asph started as an association "representing university faculties concerned with graduate education of professional personnel for service in public health; to promote and improve education and training of such personnel, and to do such other things as may improve the supply of trained personnel for all phases of public health activity." over time, asph became the national organization whose members are ceph-accredited sph, not just in the us but internationally with inclusion of an accredited school in mexico and an associate member school in france, which is in the process of accreditation. asph membership includes all cephaccredited member schools, in ( figure ), , which together, graduate over , students each year. growth of schools and students in the most recent period has been dramatic ( figure ). additionally, six associate member schools are scheduled to become fully accredited sph within the next two years, and others have indicated intent to become fully accredited. , growth of schools is expected to continue as states and private institutions recognize their value, and student interest grows. ceph accredits about public health programs in a variety of kinds of institutions, e.g., mph programs in medical schools. some programs are not ceph-accredited. estimates gathered from (association for prevention teaching and research; unpublished survey) indicate that less than , graduates/year come from ceph-accredited programs. the number of graduates from unaccredited schools and programs is unknown. several large, for-profit, online universities also offer public health programs and degrees. there is considerable concern about the growth and quality of these programs. in an effort to establish public health as a recognized, certified profession, asph, apha, the association for prevention teaching and research, the association of state and territorial health officials and the national association of county and city health officials established the national board of public health examiners (nbphe) in september . nbphe's purpose is to "ensure that students and graduates from schools and programs of public health accredited by ceph have mastered the knowledge and skills relevant to contemporary public health." nbphe is an active, independent organization that develops, administers and evaluates a voluntary certification exam once every year. graduates of cephaccredited schools and programs are eligible to take the exam. as of this writing, the number of examinees each year is small (about , ) but growing. it is not known what the ultimate effect of the exam will be on job availability, selection, salaries or on the quality of the public health workforce. ceph's focus is improvement of health through assurance of professional personnel who can identify, prevent and solve community health problems. the council has several objectives, including to: promote quality in public health education through a continuing process of self-evaluation by schools and programs that seek accreditation. assure the public that institutions offering graduate instruction in public health have been evaluated and judged to meet standards essential for the conduct of such educational programs. encourage-through periodic review, consultation, research, publications, and other means-improvements in the quality of education for public health. to achieve this mission, ceph reviews sph resources, structure and programs through its established criteria, which are updated periodically. accredited sph must offer coursework in at least the five core areas of knowledge basic to public health: biostatistics; epidemiology; environmental health sciences; health services administration; and social and behavioral sciences. the core, broad knowledge areas form the basis of how schools structure curricula. however, schools are not limited to these disciplinary areas. some schools have added departments of genetics, maternal and child health, nutrition and other areas. nothing precludes expansion of the five core areas, but all students must get sufficient exposure to core public health disciplines (table ) . over the last several years, asph has developed competencies in a number of areas, such as undergraduate education and master of public health programs, and identified cross-cutting areas, such as cultural competence, public health biology and health informatics which augment the disciplinary focus of the core areas. review of competencies shows the richness of subject matter area included under disciplinary areas, such as epidemiology. across schools, it is expected that students gain skills in a variety of areas and also emerge with understanding about the multiple determinants of health, using the kind of social ecologic model identified in the iom report, who will keep the public healthy? the accreditation process is based on peer review, in which a site visit team visits each school and evaluates their self-study and the processes behind it. according to the ceph website , site visitors must: be a senior academician (e.g., dean, associate dean, department chair or senior faculty member); or a senior public health practitioner (i.e., primarily employed by a public health department, non-profit organization, healthcare organization, etc. with preferably at least years of experience in public health); and have at least a master's degree (practitioners) or a doctoral degree (academicians); and possess strong writing, communication and analytical skills. ceph is responsible for selecting site visit teams, chairs and assuring that guidelines are followed throughout the accreditation process for each school (table ) . in , ceph amended and strengthened accreditation criteria for schools. sph now are required to have at least five full-time faculty members for each of the five core areas of study (minimum of faculty members) and must offer at least three doctoral degrees in three distinct programmatic areas. again, they are not restricted to this minimum, and most mature schools have many more programs. some also offer joint degrees with schools of social work, medicine, dentistry, nursing, city and regional planning, law, business, information and library sciences and other areas. accreditation requirements are a floor and not a ceiling. • environmental factors including biological, physical and chemical factors that affect the health of a community. • planning, organization, administration, management, evaluation and policy analysis of health and public health programs. • concepts and methods of social and behavioral sciences relevant to the identification and solution of public health problems. schools must be independent, with status similar to other professional schools at their universities. that aside, the perceived value of sph undoubtedly varies across universities and is likely to be affected by a school's rankings, success in obtaining grants and contracts and other issues. criteria for programs are similar to those for schools, with some differences. each degree program and area of specialization must have clearly stated competencies that guide development of educational programs. these define what a successful learner should know and be able to do upon completion of a particular program or course of study. asph developed master's degree core competencies in to serve as a resource and guide and continues to develop competencies in several other priority areas, such as preparedness. accreditation has both advantages and disadvantages. from the perspective of students and the field, accreditation assures a minimum level of quality in relation to established criteria. specifying core disciplines that must be represented and taught, identifying core competencies and clearly specifying relationships between goals, learning objectives and student outcomes is a strength of the process. but such a process also carries threats to innovation if criteria are interpreted too narrowly and do not permit new developments in format, methods and content of training programs. there also is more emphasis on teaching and service aspects of schools and less on research which, for research universities, is an important part of the mission. in addition, costs of accreditation, both direct and indirect, have grown as the complexity of the process has grown. lengthening the time period between reviews might be appropriate in view of this. fifty years ago, the profile of a public health student was a white physician or nurse who pursued an mph in order to practice at a health department or other similar setting. today, about eight percent of public health students have medical degrees. current public health students are younger, with less work experience, and more varied in the academic disciplines and the perspectives they bring to the profession. they also are more diverse in terms of ethnicity, race, age, socioeconomic backgrounds and culture and related characteristics. , students' and trainees' characteristics vary as much as diversity of the schools themselves. in , over , students were enrolled in accredited sph (table ) ; about one third of students were part-time, and many were trained in online programs with limited in-person classroom contact hours (distance education offered at schools). in , females represented percent of graduates. minorities (including asians) received percent of graduate degrees awarded to us students. sixty percent of graduates received mph degrees. doctoral degree recipients were dominated by phds, about -fold more often than doctor of public health graduates. international students, despite small dips in enrollment in recent years, continue to grow and now constitute percent of graduates. in , across all accredited sph, there were over , faculty members. overall, program areas with highest concentrations of graduates are health services administration ( %), epidemiology ( %) and health education/behavioral sciences ( %). "other" program areas included percent of graduates, despite efforts to categorize degree classifications into one of the ten categories in asph's annual survey. this may reflect diversity of offerings, as well as efforts to adapt to new priority areas and other emerging areas of focus, such as health equity, health systems modeling, public health preparedness, health implications of climate change, and chronic disease prevention. graduates from public health accredited schools and programs conduct research and teach in universities, international bodies and nonprofit organizations, manage healthcare and health insurance systems, work in the private sector and for foundations, are public health leaders in state, local and federal health agencies, and work globally and locally in many different roles. in the us, academic public health continues to grow in size and stature. the scope of public health education is expanding to new collaborations among health professions and other professional degree programs and includes college and even high school students. broadening public health education as a core body of knowledge for students, not just in other health professional schools but well beyond, was augured by the iom's report, who will keep the public healthy? specifically, the report called for a dramatic upsurge in master's level training in public health for medical professionals, citing the need to train as many as half of all medical school students at this level. inter-professional education extends far beyond more traditional medicine and public health training. for public health, it is seen when multiple professions' disciplines collaborate to advance the knowledge and skills of professionals and students. public health schools have a long history of collaboration with other schools and colleges within their own universities. these include formal dual degree opportunities. some of the most common joint degrees include mph/md degrees, but also degrees joint with law (mph/jd), dentistry (mph/dds), social work (mph/msw), nursing (mph/msn), business (mph/mba) and veterinary medicine (mph/dvm). several schools offer dual degree training with schools of communications, journalism, information and library science, public policy, city and regional planning, education and international affairs. these combinations allow students to integrate curricula towards their particular interests. there is no conceptual limit to potential joint and dual degree programs; they are likely to increase in the coming years. for many years, a small number of schools offered undergraduate study of public health including public health majors. recently, public health has emerged in a broad spectrum of undergraduate programs amidst growing interest in public health. in , the american association of colleges and universities surveyed their membership and found that institutions offered undergraduate majors, minors or concentrations in public health. universities with sph clearly dominate the playing field, with schools offering public health as a major area of concentration, and offering a minor concentration, accounting for nearly , under graduate students in . a recent front page washington post story captured this interest, in an article entitled "for a global generation, public health is a hot field." public health as a field has an increasingly wide appeal for students concerned with what the st century holds for the world's population, and some potential applicants would like to be able to enter the field with less time in school. additionally, there is also increased attention to opportunities at the community college level for public health education. applicants' interest in sph is growing at a remarkable rate, eclipsing other health professional fields, such as medicine. there was a percent growth in the number of applicants between and , from about , to , / year. despite annual healthcare costs in the neighborhood of $ trillion usd/ year, the us ranks th in life expectancy and nd in infant mortality among the world's nations. the us invests less than two percent of each heathcare dollar on prevention while spending percent of that dollar treating preventable diseases. such an imbalance defies peer-reviewed findings that show prevention activities in most instances are far more costeffective in improving health than medical treatment. , unlike medical schools, sph do not receive core federal funding for education [beyond a small pool of students], such as is received through medicare funding for medical residents or core federal funding for research and service/care available through the veterans administration for faculty effort. while the nih bench science model drives much of the highly valued research at sph, progress has been made in garnering nih and foundation support for applied research in epidemiology, behavioral sciences, health policy, and environmental health. limited fiscal resources, however, often make it difficult to mobilize and sustain research articulated by the practice sector and communities of need. funding for sph comes from a variety of sources, which include: tuition and federal sources: health resources and services administration (hrsa), cdc and nih funding of students; research supported by federal, state, city and not-for-profit organizations (~$ million in ), and foundation, corporate and philanthropic support. state and city universities and colleges often receive support from the relevant governmental level. the amount of this support varies, and has in general been significantly declining in recent years. for example at uc berkeley and ucla, core support has eroded to about percent. funding at sph ebbs and flows depending on current governmental priorities. as mcginnis and foege observed, "one of the most difficult challenges is that the urgent does not crowd out the important. in health, this challenge is especially difficult, because urgent matters can be so riveting…" examples of interventions with known major impacts on individual health include tobacco control and injury prevention activities. however, as colgrove et al. stated, "the current funding system for sph is piecemeal and largely reactive and constrains the ability of sph to meet essential societal needs. we argue that the federal government should invest significant and sustained financial support for this work through a dedicated funding stream." this would be a milestone for a field that lacks support to carry out its essential functions. several programs at sph contribute to the nation's health through provision of effective, up-to-date public health training to public health workers via a network of regional centers. to successfully carry out their charge, these centers have formed formal partnerships, particularly with local and state health agencies. in late , hrsa funded public health training centers (phtc), of which are located at sph, nearly doubling the previous network of training centers. phtcs aim to develop the existing public health workforce as a foundation for improving the infrastructure of the public health system. phtcs are based on collaborations with health departments and foster close advisory roles for academia and practice partners in their geographic areas. cdc-supported centers for public health preparedness (cphp) which began in and funded schools to prepare frontline public health workers to respond to bioterrorism and infectious disease outbreaks. in , these centers were redesigned, and new preparedness and emergency response learning centers (perlc) were funded at schools. these centers support workforce development needs by offering assistance to their state, local and tribal public health partners and are developing consistent curricula using public health workforce competencies. in , cdc funded nine schools to establish preparedness and emergency response research centers (perrcs). centers connect public health researchers with scientists involved in business, engineering, legal, and social sciences and conduct research that will evaluate the structure, capabilities, and performance of public health systems for preparedness and emergency response activities. the cdc prevention research centers (prc) program funds prevention centers, the majority of which are housed in sph. the prc program is an effective model for applied population-based prevention research. community and research partners collaborate to develop programming and identify successful aspects of research projects that can be disseminated to other communities. prcs play a leading role in translating bench and clinical research findings into practice in complex and diverse community settings. this kind of research, which adapts, refines, and demonstrates the effectiveness of community interventions, is contributing to understanding mechanisms for improving the health of populations. prcs are integrally related to public health education, not just through interactions with community public health professionals but also through opportunities for involvement of students. examples of other research and training centers in sph include: education and research centers (niosh), which conduct research and training and make recommendations for the prevention of work-related illnesses and injuries; centers of excellence in health statistics (nchs), which improve data collection systems to help develop and evaluate prevention programs; injury prevention centers (ncipc), which fund and monitor research in three phases of injury control: prevention, acute care, and rehabilitation; centers for genomics and public health (nceh), which study all elements of our human genome and how they relate to human health and disease; public health research and education centers (phrecs) within the veteran's administration, which conduct research, education and outreach on health promotion and disease prevention activities for veterans; and, centers of excellence in environmental health (nceh), which partner with state and local health departments, to develop state-of-the-art environmental health programs based on the essential public health services. in addition to these examples, there are many other centers and institutes within sph. public health professionals have been forced over an extended period of time to do more with fewer people, a problem greatly exacerbated by the recent global recession. "given the increasing complexity of public health science, meeting these challenges means training many more specialists in the many sub-disciplines of public health. as well, the availability and capacity of a global public health workforce needs to be significantly expanded." although for some time, there has been widespread recognition that the us has a shortage of well-trained public health professionals, no quantitative estimates of projected needs had been taken prior to . at that time, a taskforce of the asph set about quantifying public health workforce needs projected for . , , we summarize below the findings and implications of the workforce report and related subsequent efforts. as shown in table , "in , there were , fewer public health employees than in . , the workforce ratio in - public health workers for every , us residents-although a likely underestimate of need, was used as a benchmark. given population increases, a total of , (vs. the , available) would have been necessary in to maintain the workforce ratio that existed two decades earlier. in , a public health workforce of more than , would be needed to achieve the : , ratio. that creates a need for some , more workers than are available today." table public health workforce to us population ratios even that number is undoubtedly conservative, since public health departments across the us absorbed substantial personnel cuts during the recession of - . extrapolation of these data to projected shortages by state is demonstrated in figure . these estimates also do not take into account the large potential retirement effects of an aging worker cohort. although some retirements may be postponed due to the economic recession, by , more than , us public health workers in government- percent of an estimated , -person workforce-will be eligible to retire. in addition, the estimates are supply-based and do not attempt to quantify need or demand or the serious issue of geographic distribution and discipline-specific projects (e.g., laboratory workers vs. epidemiologists). several other organizations (e.g., apha , trust for america's health, association of academic health centers (aahc) ) and efforts have addressed specific disciplines. for example, the american association of medical colleges (aamc) has reported a shortage of , public health physicians, recommending a doubling of public health physicians currently in practice. moreover, there are demonstrated racial and ethnic disparities and significant geographic gaps in the public health workforce as the sullivan commission on diversity in the healthcare workforce concluded. "today's physicians, nurses, and dentists have too little resemblance to the diverse populations they serve, leaving many americans feeling excluded by a system that seems distant and uncaring. the fact that the nation's health professions have not kept pace with changing demographics may be an even greater cause of disparities in health access and outcomes than the persistent lack of health insurance for tens of millions of americans." sullivan commission on diversity in the healthcare workforce. public health workforce shortages are even more critical in much of the developing world. for example, sub-saharan africa has percent of the world's population and percent of the global burden of disease-yet it commands less than one percent of the world's health expenditures. the world health organization has said there is a "major mismatch" between population needs and the available public health workforce in terms of overall numbers, relevant training, practical competencies and sufficient diversity to serve all individuals and communities. , events and population health changes of the last few decades, have shown that countries do not exist in isolation and are increasingly interdependent. , , health professionals move from one country to another in a permeable manner. similarly, health conditions know no borders. , an epidemic that starts in the us, africa or thailand may become worldwide for non-communicable conditions as well as communicable diseases. tobacco companies found global markets after they became stymied in the us. a similar phenomenon is occurring with regard to availability of processed foods and obesity. the internet has made global communication instantaneous and accessible to more and more individuals regardless of country. burgeoning funding for aids through the us president's emergency fund for aids relief (pepfar) provided support for many public health researchers to conduct global research. older us sph have undertaken global activities for many years, although in the past, the area was referred to as international health. in dreaming of a time, korstad described the global travels and sanitation consultation of faculty in environmental sciences and engineering at the university of north carolina in the 's and 's. in other departments, faculty members and students traveled around the world as they worked on health projects. participation of americans in leading roles in international health, such as outlined in the preface to this edition by donald henderson, was not uncommon. however, except in a few schools with organized departments of international health (such as harvard and johns hopkins), systematic attention to international/global health was inconsistent. asph is leading an effort to develop global health competencies, and individual schools have been engaged in this effort as well. to many, global health and public health are indistinguishable. both global health and public health share many characteristics, including an emphasis on population-level policies, as well as individual approaches to health promotion. the commission on education of health professionals for the st century said that "maintaining a comparative global perspective can enrich existing curricula, thereby reducing the demand for extra time and space." the current focus on global health, separate from international health, is broader and not solely about developing countries. the us is approaching years of formalized public health professional education. some features present at the outset remain today, notably, recognition of a distinct field that is science-based across a broad spectrum of activities, from the laboratory to bedside to communities, both domestically and globally. there continues to be some tension about the relationship between medicine and public health, with some holding to distinct boundaries, and others claiming the need for better integration. however, with broad research collaborations across schools and growing numbers of medical students receiving public health training, old dichotomies between medicine and public health are breaking down. even the term has come under review, with an increasing number of cited references referring to population health as a better descriptor of the field conventionally known as public health. much has changed; with change has come evolution in the structure and functions of public health education. globalization has spared little, and certainly not the health arena. as recognition of the importance of global health has grown, and with it, attendant economic resources, the area of global health -which an increasing number would define as synonymous with global public health -has caught on with great interest, capturing the increasing attention of the medical education and care communities as well. , public health schools and training programs have responded to the growing interest of students and have flourished as they couple this interest with longstanding activities of their own faculties. perhaps most dramatic over the past years is growth in numbers of students and their diversity. this trend promises to continue despite economic challenges created by recession. our field is exciting and better understood than it has been throughout most of its history. the importance of public health education should continue to grow, not only as its own distinct field but in the context of increasing interprofessional education, team-based learning and increasing opportunities to link research and education to didactic learning and practice, in the us and globally. over the last few decades, there has been greater attention paid to building the evidence base for public health, adapting a model that originally was built for medicine and operationalized in the us preventive services task force (uspstf). the cdc's task force on community preventive services is the us body charged with assessing evidence for public health interventions. , focus on building the evidence base for public health is an important trend. this review has not focused on changes in healthcare delivery and payment that accompany the patient protection and affordable care act. expansion of health insurance coverage for millions of americans is accompanied by a number of central issues relevant to public health education, including a central emphasis on the importance of prevention and public health, with recognition of the importance of workforce development and funding. moreover, there is a large role for sph in conducting comparative effectiveness research to answer important questions about which public health and healthcare interventions are most effective in practice. we look forward to major opportunities to improve and innovate in public health education as a result of the passage of this historic legislation. as we enter a new decade, well-trained public health graduates are needed more than ever before. we face huge global threats, such as lack of safe water, emerging infections, wars, global income inequality, climate change, global obesity epidemic and changing demographic patterns associated with global aging. new technologies have potential to ameliorate some of the divide between rich and poor, developed and developing countries by providing access to information and tools to use information for improving the health of individuals and societies. as globalization makes the world smaller, public health graduates from the us and other countries are needed to strengthen health systems around the world. the complexity of these problems requires that students be trained, not in disciplinary silos but in interdisciplinary environments where they learn how to discover, find, synthesize and use information for health improvement. the commission on health professionals for a new century, an ambitious agenda for health professional training in the new century concluded, "the next generation of learners needs the capacity to discriminate vast amounts of information and extract and synthesize knowledge that is necessary for clinical and population-based decision making." new skills, like data mining and visualization, will become increasingly important as we face terabytes of data that require sense making. research synthesis and health informatics also are likely to be increasingly important. some schools have begun to integrate teaching of the core disciplines, on the assumption that most students will work in interdisciplinary settings, and that the silo approach to disciplines is no longer appropriate. over time, it is likely that there will be more integrated teaching and learning across disciplines, because the amount of content is growing at an enormous rate, beyond what can be absorbed into courses conducted in isolation. inter-professional training should become more frequent, as well. we look forward with great interest and enthusiasm to changes that are likely to come in sph as our students increasingly demonstrate that they learn and communicate very differently than their predecessors. the millennial generation of students and teachers is expanding conventional teaching with their use of new media and their skills for information search and synthesis. , we anticipate that, coupled with additional technological advances, these factors will drive significant changes in the way we educate future generations of public health professionals. for example, future classrooms are likely to offer global connections to facilitate hybrid learning, with students from different countries participating in discussions. students increasingly view themselves as global citizens, and that bodes well for the future of public health. need for stable core funding for schools of public health. changing patterns of teaching and learning for new generations of students. integrating global and domestic missions of public health. integrating academic and practice missions. accommodating the tremendous knowledge explosion within the context of accreditation expectations. dealing with new problems, (e.g., climate change), and new disciplinary areas, (e.g., neuroscience). need for more inter-professional education among health sciences schools. accredited schools of public health have grown and continue to grow in number, depth and breadth. despite growth of programs, there is widespread recognition that the us has a shortage of well-trained public health professionals. accredited sph train professionals at multiple levels, provide service to local and global communities, and conduct and translate research at the individual, community and societal levels. despite many successes in addressing public health practice contributions in academia, there remain many challenges (e.g., most schools lack consistent funding mechanisms that are not research-oriented). with globalization and increased complexity involved in strengthening health systems around the world, today's students must be trained, not in disciplinary silos but in interdisciplinary environments. institute of hygiene: a report to the general education board of rockefeller foundation professional education for public health in the united states evolution of public health and preventive medicine in the united states the future of public health. institute of medicine of the national academies the future of the public's health in the st century who will keep the public healthy? educating public health professionals for the st century. institute of medicine of the national academy of sciences disease and discovery: a history of the johns hopkins school of hygiene and public health medical education in the united states and canada: a report to the carnegie foundation for the advancement of teaching health professionals for a new century: transforming education to strengthen health systems in an interdependent world federal support of schools of public health state support for higher education continues to fall are schools of public health needed to address public health workforce development in canada for the st century? public health preparedness centers for public health preparedness program: from vision to reality asph: association of schools of public health asph: association of schools of public health. member schools map nbphe: national board of public health examiners changing demographics of public health graduates: potential implications for the public health work force association of schools of public health. asph annual data report asph policy brief -confronting the public health workforce crisis: executive summary liberal education and public health: surveying the landscape for a global generation, public health is a hot field. the washington post a call to action: public health and community college partnerships to educate the workforce and promote health equity association of schools of public health. asph policy brief -creating a culture of wellness: building health care reform on prevention and public health greater use of preventive services in the us health care could save lives at little or no cost the immediate vs. the important schools of public health: essential infrastructure of a responsible society and a st-century health system ga: the centers for disease control and prevention the public health workforce : new challenges for the health-care workforce, a critical prognosis. the chronicle of higher education public health personnel in the united states : second report to congress bureau of health professions. the public health workforce enumeration issue brief -the public health workforce shortage: left unchecked, will we be protected public health workforce shortages out of order, out of time: the state of the nation's public health workforce: a report by the association of academic health centers physician shortages to worsen without increases in residency training sullivan commission on diversity in the healthcare workforce. missing persons: minorities in the health professions taking stock: health worker shortages and the response to aids working together for health: world health report global health is public health towards a common definition of global health dreaming of a time: the school of public health: the university of north carolina at chapel hill, - . chapel hill: the university of north carolina at chapel hill on the eradication of smallpox and the beginning of a public health career developing competencies for a graduate school curriculum in international health patient protection and affordable care act committee on comparative effectiveness research prioritization board on health care services. initial national priorities for comparative effectiveness research the future of learning institutions in the digital age teaching digital natives key: cord- - a u tm authors: masic, izet; naser, nabil; zildzic, muharem title: public health aspects of covid- infection with focus on cardiovascular diseases date: - - journal: mater sociomed doi: . /msm. . . - sha: doc_id: cord_uid: a u tm introduction: covid- is the disease caused by an infection of the sars-cov- virus, first identified in the city of wuhan, in china’s hubei province in december . covid- was previously known as novel coronavirus ( -ncov) respiratory disease before the world health organization (who) declared the official name as covid- in february . aim: the aim of this study is to search scientific literature in the biomedicine and analyzed current results of investigations regarding morbidity and mortality rates as consequences of covid- infection of cardiovascular diseases (cvd), and other most common chronic diseases which are on the top mortality and morbidity rates in almost all countries in the world. also, to propose most useful measures how to prevent patients to keep themselves against covid- infection. methods: we used method of descriptive analysis of the published papers with described studies about corona virus connected with cvd, and, also, guidelines proposed by world health organization (who) and european society of cardiology (esc), and some other international associations which are included in global fighting against covid- infection. results: after searching current scientific literature we have acknowledged that not any evidence based medicine (ebm) study in the world during last months from the time when first cases of covid- infection was detected. also, there is no unique proposed ways of treatments and drugs to protect patients, especially people over years old, who are very risk group to be affected with covid- . expectations that vaccine against covid- will be produced optimal during at least months to years, and in all current guidelines most important proposed preventive measures are the same like which one described in strategic documents of who, in statements of declaration of primary health care in alma ata in . conclusion: who proposed preventive measures can be helpful to everybody. physicians who work at every level of health care systems, but especially at primary health care level, must follow those recommendations and teach their patients about it. but, the fact is that current focus of covid- epidemic has targeted on protection of physical health of population in global, however, the influence on mental health which will be one of the important consequences of covid- pandemic in the future, and which could be declared as «post-coronavirus stress syndrome„ (pcss) could be bigger challenge for global public health. viruses have hit the world several times, causing significant mortality, economic loss, and global panic. the sars outbreak in triggered deaths among more than patients in countries, followed by the emergence of mers in , which resulted in at least deaths among patients in countries ( ) . besides coronaviruses, avian and swine influenza remain a concern for global public health in the h n pandemic alone, there were laboratory-confirmed deaths and more than . deaths from respiratory disease worldwide ( ) . in late , a cohort of patients presenting with pneumonia of varying acuity and unknown aetiology in wuhan, china, heralded the outset of covid- . as of . . , total of , confirmed cases (including , deaths in geographical territories) have been reported to the who, and this number is still increasing. although covid- appears to have greater infectivity and lower mortality than sars and mers, many uncertainties (including route of infection, viral evolution, epidemic dynamics, appropriate anti-viral treatment, and strategies for disease control) remain. on march , , the who declared covid- a pandemic ( ) . since there is no cure for this viral disease and a long wait is needed to find a vaccine, a rigorous epidemiological measure was first taken. the largest quarantine in history was made, between and million people in several chinese cities were quarantined; which included necessary hygiene measures, group meetings were canceled, schools closed, and travel banned. some believe that a later evaluation of all the more modern epidemiological measures will show whether all of them are justified, as experts point to procedures that curb a severe acute respiratory syndrome (sars) caused by another type of virus corona. cardiovascular complications of influenza infection, including myocarditis, acute myocardial infarction, and exacerbation of heart failure have been well-recognized during previous historical epidemics and make a significant contribution to mortality ( ) . likewise, previous coronavirus outbreaks have been associated with a significant burden of cardiovascular comorbidities and complications. furthermore, the severity of the primary respiratory syndrome and risk of adverse outcomes is increased in patients with pre-existing cardiovascular diseases ( , ) . hypotension, tachycardia, bradycardia, arrhythmia, or even sudden cardiac death are common in patients with sars. electrocardiographic changes and troponin elevation may signal underlying myocarditis, and echocardiography frequently demonstrates subclinical left ventricular diastolic impairment (with a higher likelihood of the need for mechanical ventilation in those with systolic impairment and reduced ejection fraction) ( , ) . early covid- case reports suggest that patients with underlying conditions are at higher risk for complications or mortality -up to % of hospitalized patients have a chronic medical illness ( % cardiovascular or cerebrovascular disease). in the largest published clinical cohort of covid- to date, acute cardiac injury, shock, and ar-rhythmia were present in . %, . %, and . % of patients, respectively ( ), with higher prevalence amongst patients requiring intensive care. cvds may become unstable in the setting of viral infection as a consequence of imbalance between infection-induced increase in metabolic demand and reduced cardiac reserve. patients with coronary artery disease and heart failure may be at particular risk as a result of coronary plaque rupture secondary to virally induced systemic inflammation, and rigorous use of plaque stabilizing agents (aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors) has been suggested as a possible therapeutic strategy. pro-coagulant effects of systemic inflammation ( ) may increase the likelihood of stent thrombosis and assessment of platelet function and intensified anti-platelet therapy should be considered in those with a history of previous coronary intervention. the clinical effects of pneumonia have been linked to increased risk of cvd up to -year follow-up ( ) and it is likely that cases infected via respiratory virus outbreaks will experience similar adverse outcomes. therapeutic use of corticosteroids further augments the possibility of adverse cardiovascular events. however, long-term follow-up data concerning the survivors of respiratory virus epidemics are scarce. lipid metabolism remained disrupted years after clinical recovery in a metabolomic study amongst sars survivors ( ) , whereas cardiac abnormalities observed during hospitalisation in eight patients with h n influenza returned to normal at -year follow-up ( ) . whilst viral phenotype, baseline clinical characteristics, initial disease severity, and immediate management impact on shortterm survival, long-term prognosis following outbreaks of respiratory virus infection may equally depend upon the extra-pulmonary manifestations. serial follow-up studies amongst the survivors of acute infection are surely needed. autopsy findings of deaths due to infection with the new virus (covid- ) revealed that mortality was lower in pulmonary patients compared to cardiac patients or patients with diabetes, and mortality of hypertensive patients was similar to that in lung patients. doctors quickly looked to see if any of the existing medicines were leading to an improvement in their condition. first, chinese experts have shown that the antimalarial drug (chloroquine) is effective in patients. then, a few days ago, french researchers showed in a very small group of patients that the concomitant administration of hydroxychloroquine and azithromycin (sumamed) had an even better effect in covid- patients. although these studies are insufficient (due to small sample size and poor clinical experimental design), they indicate that, despite the adverse effects of azithromycin (severe diarrhea due to clostridium difficile and prolonged qt interval on ecg), mortality due to infection with a new virus. it should be noted that in , researchers at the pliva drug factory found a macrolide antibiotic, azithromycin, but sold all distribution rights to the european community and the us in to pfizer ( ) . some pharmacologists believe that because certain growth-inhibiting agents, such as cepharanthin, selamectin or mefloquine hydrochloride, affect replication of coronaviruses in vitro, these agents might be used to treat covid- infection in vivo, but it will first be necessary to check their clinical efficacy of cepharanthin (an ingredient in the local plant stephania cephalantha) has been used in japan since almost years ago for a number of acute and chronic diseases because it has various pharmacological effect including anti-inflamatory, anticancer, and antiviral effects ( ) . there is a considerable debate among biomedical scientists and physicians as to whether patients should stop taking ace inhibitors (acei: enalapril, lisinopril, ramipril and others) and angiotensin receptor blocking drugs (arb: losartan, eprosartan, valsartan and others) due to their increase of ace- activity and rise of the ace- receptors ( ) . these drugs help thousands of patients with high blood pressure, chronic heart failure, diabetic kidney damage and other vascular disorders ( ) . discontinuing these medicines could have many serious consequences, although medical opinions remain divided ( ) . on the one hand, there is an indication that these renin-angiotensin blockers could exacerbate coronavirus disease, but on the other hand, some preliminary data show that they are beneficial ( ) . controlled clinical trials will establish whether these drugs should be temporarily discontinued (and in which patients) or whether they should even be given to individuals infected with covid- . for now, no one should omit taking any of these medicines. the european medicines agency (ema) has issued a statement advising that patients continue treatment with angiotensin-converting enzyme (ace) inhibitors and angiotensin ii receptor blockers (arbs), despite widely circulated reports that the agents could worsen coronavirus disease ( ) . "it is important that patients do not interrupt their treatment with ace inhibitors or arbs and there is no need to switch to other medicines", the agency said today. "there is currently no evidence from clinical or epidemiological studies that establishes a link between ace inhibitors or arbs and the worsening of covid- ". the new guidance is in line with that recently issued by the european society of cardiology and three american cardiology societies. the medications are commonly used by patients with hypertension, heart failure, and kidney disease. because the coronavirus infects human cells by binding to ace receptors and because these medicines can increase ace , it has been suggested that they could increase virus activity. however, the interactions of the virus with the renin-angiotensin-aldosterone system in the body are complex and are not completely understood, the agency notes. "the speculation that ace-inhibitors or arbs treatment can make infections worse in the context of covid- is not supported by clinical evidence", the ema reiterated. although not noted in the statement, other reports have suggested that ace inhibitors and arbs may reduce the risk for or severity of viral pneumonia in patients with covid- infection, or may actually have potential as treatments. the ema is collaborating with stakeholders to generate further evidence in epidemiologic studies on the effects of ace inhibitors and arbs in people with . in light of circulating reports questioning whether nonsteroidal antiinflammatory drugs (nsaids), such as ibuprofen, also could worsen covid- , the agency also recently issued guidance on the use of nsaids during the pandemic. the ema highlighted that most ibuprofen-containing medicines in the eu are authorised at national level, as a painkiller and in some countries also as an antipyretic (fever treatment medicine). they are widely available over the counter and on prescription. oral ibuprofen (over the counter or with a prescription) is used, depending on the presentation, in adults, children and infants from the age of three months, for the short-term treatment of fever and/or pain such as headaches, flu, dental pain and dysmenorrhoea (period pain). ibuprofen is also prescribed for the treatment of arthritis and rheumatic conditions. ketoprofen is a similar medicine, mostly prescribed for use in various painful and inflammatory conditions although in some member states it is available over the counter. ibuprofen has also been authorised centrally as pedea to treat 'patent ductus arteriosus' in newborn premature babies ( ) . the ema highlighted the need for future epidemiologic studies and stated: "there is currently no scientific evidence establishing a link between ibuprofen and worsening of co-vid- ". there is currently no scientific evidence establishing a link between ibuprofen and worsening of covid- . ema is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic ( ) . in may , ema's safety committee (prac) started a review of the non-steroidal anti-inflammatory medicines ibuprofen and ketoprofen following a survey by the french national agency for medicines and health products safety (ansm) which suggested that infection due to chickenpox (varicella) and some bacterial infections could be made worse by these medicines. the product information of many nsaids already contains warnings that their antiinflammatory effects may hide the symptoms of a worsening infection. the prac is reviewing all available data to see if any additional measure is required ( ) . when starting treatment for fever or pain in covid- , patients and healthcare professionals should consider all available treatment options including paracetamol and nsaids. each medicine has its own benefits and risks which are reflected in its product information and which should be considered along with eu national treatment guidelines, most of which recommend paracetamol as a first treatment option for fever or pain ( ) . in line with eu national treatment guidelines, patients and healthcare professionals can continue using nsaids (like ibuprofen) as per the approved product information. current advice includes that these medicines are used at the lowest effective dose for the shortest possible period. further to the ongoing prac safety review on ibuprofen and ketoprofen, ema highlights the need for epidemiological studies to be conducted in a timely manner to provide adequate evidence on any effect of nsaids on disease prognosis for covid- . the agency is reaching out to its stakeholders and is ready to actively support such studies, which could be useful in guiding any future treatment recommendations. ema will provide further information as necessary and once the prac review is concluded ( ) . for ) ; however, this information is provisional and likely to changi. more than % of infected patients experience mild symptoms and recover without intensive medical intervention. however, morbidity and mortality increase significantly with age, rising to . % among patients - and . % in patients over in large-scale chinese case reporting. published case reports from the chinese centers for disease control indicate patients with underlying comorbid conditions have a heighted risk for contracting covid- and a worse prognosis; depending on the report, between % and % of covid- patients present with underlying conditions. case fatality rates for comorbid patients are materially higher than the average population: cancer: . %, hypertension: . %, chronic respiratory disease: . %, diabetes: . % and cvd: . % ( ) ( ) ( ) ( ) ( ) . during the sars epidemics in and the mers epidemic in caused by the sars cov- virus, the course of the disease responded to acute respiratory viral infections, but a large number of patients had more severe forms of the disease followed by fatal outcome ( ) . mortality was significantly higher in patients with chronic comorbid conditions. impairment in the immune response to the virus led to severe respiratory failure, which was accompanied by alveo-capillary block due to the diffuse inflammation of the alveolar and vascular structures of the lung, as the body's immune system activates proinflammatory mediators (cytokines and others) that cause block of the alveolar activation and surfactant inactivation. this condition is known as acute respiratory distress syndrome (ards) and requires the respirator application ( ) . death is usually caused by the multiorgan dysfunction. the current covid- pandemic, also, caused by the corona virus sars cov- , has clinical manifestations as in previous outbreaks, and the virus itself has great genetic similarity to the previous sars cov- . the current pandemic, however, has led to dramatic changes in the lives of every inhabitant of this planet, and the greatest challenges for each country public health and health care systems. despite the genetic similarity, the new virus has other modes of transmission, and appears to have a greater ability to block an adequate immune response, leading to more severe forms of ards. after it causes respiratory symptoms, the virus infects all other organ systems (cardiovascular, hematopoietic, digestive, then the kidney, skin, cns) through the blood (viremia) and can lead to multiorgan failure. the ace receptors, which are used by the virus to enter the cells of the respiratory system for reproduction, also have other organs, which can be affected at the very beginning of the disease. such a condition can lead to an overreaction of the immune system with the production of a number of inflammatory mediators such as cytokines, and cause "cytokine storm" ( ) . patients with covid- infection have, in addition to the symptoms of acute respiratory infection, clinical signs of other diseases. cases with clinical presentation of active gastroenterocolitis with predominance of diarrhea and bleeding have been described. initial autopsy and biopsy reports of various tissues indicate pathological changes in almost all organ systems. blood tests of patients with co-vid- almost always show haematological changes that indicate a disorder of coagulation and immunological status. a large percentage of patients have proven high levels of aminotransferases and it can be assumed that the liver is among the first organs attacked by the virus. the question of the future course of the disease remains unanswered, given the possibility of mutation. patients with covid- have short-term immunity, but there is the possibility of reinfection and persistent carriers of the virus (similar to b hepatitis positive) ( ) . the current major challenge for public health is the comprehensive public health protection at the level of community and family medicine units and their well-educated teams on the features, etiopathogenesis and spreading of covid- infection, as well as all public health measures that have previously been applied in medical history during epidemics and pandemics of varying intensity, and there were many. experiences from the past are recorded in various educational publications, but unfortunately long unused in the scope and seriousness of approaches and methods of their application, better said, neglected in this global pandemic infection has just shown how dysplosion of the use of diagnostic and therapeutic technologies is relatively powerful to deal with and cope with the effects of a pandemic of this type or another, and how effectively their use can counteract its effects and make them as small and harmful as possible. Štampar's principles as well as the principles of arab scholars: hunayin ibn ishaq ( - ), ali ibn at-tabari (( - ), abdullah ibn sina (avicenna, - ), ibn butlan (- , philosopher and reformator of public health), alauddin ibn nafis ( - ), and other arab physicians ( days quarantine in case of epidemia has been described in avicenna's famous book "canon of medicine") ( ) , as well as numerous other medical manuscripts during arabic and the ottoman period, which still exist in many libraries in our areas today, has clearly been the method of choice, as effective vaccines are still pending. the lessons learned from these books have been passed on for centuries in bosnia and herzegovina by attars, scholars and qualified persons, most of them priests of all confessions in these areas. the same experiences are recorded in numerous manuscripts preserved in the auxiliary, but also rich libraries of franciscan monasteries, mosques, synagogues, churches, and other dedicated objects. the who's recommendations are largely based on these preventive measures, the experience of which has been around for centuries. unfortunately, the postulates of the stampar's "dispensary method" as screening method of work from the year ( ) and orientation in prevention of epidemic and pandemic type emergence and spread -the effect of which proved to be very effective in wuhan (china), where trained persons went door to door in flats and houses and sought infected, but also recorded the number of people with chronic diseases, potential for infection and possible lethal outcome. in this case the community and family play a key role in preventing the massive spread of covid- infection demonstrated the importance and value of the public health approach just mentioned in addressing this global pandemic that has occupied the entire planet, and whose consequences in all spheres and forms of life and work are likely to make us think that this approach to organizing the health system and its most important segment -the family and its members, must have a better and more serious approach to health care. because the question is how many such epidemics or pandemics will happen to us in the future -to us or our descendants. unfortunately, within the who's recommendations, there is a somewhat sophisticated current focus on cov-id- that has neglected, in practice, the appropriate treatment of a large number of patients with massive chronic non-communicable diseases, adhering to the principle of the many times the stated and declared strategic goals of "health for all". twenty years ago, the first author of this article in an earlier article cited the motto -"technologies will dehumanize medicine in the near future". it seems, as though, this is already happening, but the question is how well those who make decisions in health care systems are aware of this statement. the u.s. centers for disease control and prevention has developed interim guidance for businesses and employers to plan for and respond to . the interim guidance is intended to help prevent workplace exposures to acute respiratory illnesses, including covid- . older adults and those with underlying chronic medical conditions seem to be at higher risk, according to the cdc. as the illness is thought to spread from person to person, experts advise: wear a mask if you are sick or caring for someone. frequent hand washing, avoiding crowds and contact with sick people, and cleaning and disinfecting frequently touched surfaces can help prevent coronavirus infections are the main proposal of who experts. those preventive measures at least can help to everybody, including also to patients who have evidenced cvds in their histories of illness ( it is likely that sars-cov- will be identified in more communities, including areas where cases have not yet been reported. as such, phisycians who work at primary health care level should assume it could already be in their community and move to restrict all visitors form their home/ flats or from the other facilities; cancel group activities and communal dining; and implement active screening of residents for fever and respiratory symptoms, especially older adults often with underlying chronic medical conditions, including patients with cvd, who are at the highest risk of being affected by covid- . covid- spreads by contact with respiratory droplets that spread when an infected person coughs or sneezes. frequent hand washing, avoiding crowds and contact with sick people, and cleaning and disinfecting frequently touched surfaces can help prevent coronavirus infections ( - ). the general strategies cdc recommends to prevent the spread of covid- in ltcf are the same strategies these facilities use every day to detect and prevent the spread of other respiratory viruses like influenza ( ). covid- is being increasingly reported in communities across the world. if they are infected with sars-cov- , the virus that causes covid- , highest risk population are at increased risk of serious illness. ill visitors and healthcare personnel (epidemilogists, family phisycians, patronage nurses, health care staff for testing risk population, emergency health care medical professionals, red cross staff, etc) are the most likely sources of introduction of covid- into a facility. who recommends aggressive visitor restrictions and enforcing sick leave policies for ill hcp, even before covid- is identified in a community or facility. these recommendations are specific for nursing homes, including skilled nursing facilities. much of this information could also be applied in assisted living facilities. this information complements, but does not replace, the general infection prevention and control recommendations for covid- ( ). current guidance available on web sites (attached up in the text) are based on the currently available information about covid- . probably it will be refined and updated as more information becomes available and as response needs change regarding experiences from almost all countries world wide, covered by who rules and recommendations ot the experts in this field. experts of cdc in us concluded: "it is important to understand transmission dynamics in your community to inform strategies to prevent introduction or spread of covid- in your facility. consultation with public health authorities can help you better understand if transmission of covid- is occurring in your community." ( ). unfortunately, publich health sector in our country is still limited to be effective like it was in previously organized health care system in former yugoslavia with centralized "red and green" lines of making decissions for every prevention tasks and measures from local communities to higest (national) level. decision makers in healthcare sector of bosnia and herzegovina are "separated" and very much influenced on the same way as political system, which has not definitely useful for common people -potenital patents or murderes of covid- consequences in the future. probaly we will stay on main goals for everybody: "stay at home and keep yourself" and follow instructions how to use proposed and recommended preventive measures from public health experts, besides main act till now -testing of risk people and stay at home and improve your immunity system. especially patients registered with cvd, diabetes mellitus, cancers, and respiratory diseases. but, the fact is that current focus of covid- epidemic has targeted on protection of physical health of population in global, however, the influence on mental health which will be one of the important consequences of covid- pandemic in the future, and which could be declared as «post-coronavirus stress syndrome" (pcss) could be bigger challenge for global public health. • author's contribution: all authors contributed in the preparation of the manuscript and they were overseeing this contents of the article, had full access and responsibility of the data. final proof reading was made by the first author. • conflict of interest: none declared. • financial support and sponsorship: nil. from sars to mers, thrusting coronaviruses into the spotlight estimated global mor-tality associated with the first months of pandemic influenza a h n virus circulation: a modelling study coronaviruses and the cardiovascular system: acute and long-term implications seasonal influenza infections and cardiovascular disease mortality the novel coronavirus outbreak-a global threat prevalence of comorbidities in the middle east respiratory syndrome coronavirus (mers-cov): a systematic review and meta-analysis left ventricular perform-ance in patients with severe acute respiratory syndrome: a -day echocardio-graphic follow-up study frequency of troponin elevations in patients with influenza infection during the - influenza season clinical characteristics of hospitalized patients with novel coronavirus-infected pneumonia in wuhan, china inflammation and thrombosis: the clot thickens association between hospitalization for pneumonia and subsequent risk of cardiovascular disease altered lipid metabolism in recov-ered sars patients twelve years after infection cardiac com-plications associated with the influenza viruses a subtype h n or pandemic h n in critically ill patients under intensive care pharmacologist's view of the new corona virus cepharanthine: an update of its mode of action, pharmacological properties and medical applications sars-cov- cell entry depends on ace and tmprss and is blocked by a clinically proven protease inhibitor pharmacology of the renin-angiotensin system where are we now with covid- ? covid- and angiotensin-con-verting enzyme inhibitors and angiotensin receptor blockers: what is the evidence? jama ema says stay on angiotensin drugs during covid- pandemic -medscape clinical guidance for the cv care team. the american college of cardiology acute respiratory distress syndrome (ards) from endemic influenza a/h n : prehospital management the nrf activator (dmf) and covid- : is there a possible role? med arch golden ages of arabic-islamic medicine: the first arabic hospitals and the public health the most influential scientists in the development of public health ( ): andrija stampar ( - ) key: cord- -kueqo y authors: ma, yarong; rosenheck, robert; he, hongbo title: psychological stress among health care professionals during the novel coronavirus disease outbreak: cases from online consulting customers date: - - journal: intensive crit care nurs doi: . /j.iccn. . sha: doc_id: cord_uid: kueqo y background: during the novel coronavirus disease (covid- ) outbreak, online consulting has been widely used to address mental health problems, including health care professionals (hcps) caring for covid- patients who experienced substantial psychological distress. aim: to explore the severity of perceived stress and potential correlates among the hcps seeking online mental health services during the covid- outbreak. methods: a descriptive study was conducted among hcps to assess levels of psychological distress using the perceived stress scale (pss- ), patient health questionnaire (phq- ), and generalized anxiety disorder (gad- ) questionnaire. the hcps working in different departments were compared using χ( )-test for categorized variables and t-test for continuous ones, followed by the analysis of covariate (ancova) to compare the perceived stress. linear regression for the pss- score was performed to identify potential correlates of stress. results: the sample overall (n= ) showed a relatively moderate level of perceived stress (pss mean= . ± . ) with % identified as depressed (phq- ≥ ) and % as suffering from anxiety (gad- ≥ ). those working at intensive care units (icus) or in departments of respiratory medicine (rm) demonstrated significantly higher perceived stress than those at other departments (adjusted mean: . ±. vs. . ± . , p=. , partial η( )=. ). high perceived stress was most strongly associated with being depressed (beta=. , p=. ) and working at icus/rm (beta=. , p=. ). conclusions: the psychological health status of frontline health care professionals during the novel coronavirus outbreak warrants clinical attention. online mental health services has played a major role although its effectiveness and barriers to its utilization require further evaluation. an outbreak of novel coronavirus disease in wuhan, china spread quickly across the entire nation (yanping zhang, ) . the covid- had a clustered onset and resulted in severe and even fatal respiratory diseases including acute respiratory distress syndrome , leading to an urgent response from respiratory medicine departments and intensive care units (icus) (phua et al., ) . on february , the china cdc weekly reported that a total of , chinese health workers had been infected with the novel coronavirus, of which, six had died (w. . workplace stress on mental health experienced by critical care professionals (arrogante & aparicio-zaldivar, ) has been reported to have been adversely affected among those health care professionals (hcps) caring for patients with covid- . hcps have been reported to be highly vulnerable to experiencing physical exhaustion, sleep problems (w. , stress/fear of being infected and distributing the virus among relatives (jansson, liao, & rello, ) , and problems during counseling as care for family was hampered by strict precaution measures (pattison, ) . mental health assessment, support, and treatment are an important part of the response to the covid- outbreak , and both national and local policies addressed these mental health problems. meanwhile, online mental health services related to the stresses incurred by the epidemic have been widely provided by local and national mental health institutions(w. , to provide support for the general public, including the health care professionals. recently, several reports have noted the substantial psychological stresses (chew et al., ; lai et al., ; as well as physical symptoms (chew et al., ) experienced by hcps dealing with the covid- outbreak. however, these participants ( . %) were either from hubei province, itself, (lai et al., ) or were recruited from those working in other healthcare institutions (chew et al., ; . while online mental health services widely emerged and quickly increased during the pandemic, no studies have focused on the hcps who sought online consultations. this study reports on hcps who sought online psychological support from the staff of the affiliated brain hospital of guangzhou medical university, and examines the severity of perceived stress and potential psychiatric correlates among hcps seeking online mental health services during the covid- outbreak. a cross-sectional online survey was conducted among health care professionals who sought online psychological support provided by the staff of the affiliated brain hospital of guangzhou medical university (a large psychiatric hospital in southern china). from to february , we distributed questionnaires to a total of health care professionals ( physicians, nurses) from shandong (n= ), guangdong (n= ), yunnan (n= ), and guangxi (n= ) provinces. the participants were invited to finish complete self-reported questionnaires prior to the psychological intervention, which included a minutes discussion of stressful experiences, reactions, and coping mechanisms, with an additional minutes for questions and answers. verbal informed consent was provided by all participants prior to their enrollment in the survey. the study protocol was approved by the affiliated brain hospital of guangzhou medical university ethics committee. demographic characteristics documented included age, sex, marital status, education, occupation, and potentially direct contact with covid- patients. clinical departments were classified as ) the intensive care units (icus, n= ) and department of respiratory medicine (rm, n= ), where most suspected or confirmed covid- patients were treated, and as a comparison group of the other departments (n= ) which saw few covid- infected patients. the perceived stress scale (pss- ) (liu et al., ) , patient health questionnaire (phq- ) (kroenke, spitzer, & williams, ) , and generalized anxiety disorder (gad- ) (löwe et al., ) were used to document the level of stress, depression, and anxiety. the pss- scores range from - (low), - (moderate), and - (severe perceived stress. the total score of the phq- ranges from to , and scores of - , - , - , and - indicate mild, moderate, moderately severe, and severe depression, respectively. scores of less than five on the gad- represents no anxiety, while scores of , , and are taken as the cut-offs for mild, moderate, and severe anxiety, respectively. for this study, a cut-off greater than or equal to five on the phq- and gad- were used to classify participants as having any depressive or anxiety symptoms or not. the analysis proceeded in stages. first, hcps working in icus, rm departments or elsewhere were compared using chi-square tests for categorical variables and t-tests for continuous variables. based on analysis of covariance (ancova) least-square means adjusted for demographic differences were computed and effect size differences were calculated using η² (richardson, ) . eta squared is the proportion of the total variance that is attributed to an effect. given the exploratory nature of our study, the significant differences for each test were established at p<. , -tailed. second, stepwise linear regression was used to evaluate predictors of high perceived stress by pss- . independent variables in the model included demographics, phq- ≥ , gad- ≥ . statistical analyses were performed using ibm spss statistics for windows (version . . armonk, ny: ibm corp.) among the health care professionals, most were female ( %), with a % ranging from to years old. most were physicians ( %), and most were potentially in direct contact with covid- patients ( %). the comparison between health care professionals working at icus or rm departments and those at other departments showed the icus/rm group had less education (χ = . , p=. ); were more often nurses than physicians (χ = . , p<. ); and a significantly greater percentage had direct contact with covid- patients ( % vs. %, χ = . , p=. ). (table ) about one-third ( % vs. %) of hcps in both groups had significant anxiety (gad- ≥ ) and one-fourth ( % vs. %) had depression (phq- ≥ ). in contrast, analysis of covariance (ancova) showed significantly higher stress in the icus/rm group (adjusted mean, . ± . vs. . ± . , p=. , partial η =. ). (table ) additionally, the linear regression model indicated that higher perceived stress was significantly associated with being depressed (beta=. , p=. ) and being in the icus/rm group (beta=. , p=. ). (table ) to our knowledge, this is the first study to focus on the psychological stress of health professionals who seek online mental health services during the covid- outbreak. our investigation of the psychological stress of these hcps showed that those who cared for people with confirmed or suspected covid- , is especially stressful and that stress was worse among those with concomitant depression. compared to a multicenter sample of , chinese physicians and nurses, prior to the pandemic, of whom . % reported anxiety symptoms and . % depression symptoms in the past week (l. shi et al., ) , the current sample demonstrated a higher proportion meeting the cutoff for anxiety ( %) but similar proportions with depression ( %) in both groups. thus anxiety was common even in a well-trained team that coped well with depression during the pandemic outbreak. the frontline health care professionals, e.g., working at icus and in respiratory departments, were at high risk for infection (w. , and have been documented to have experienced fear of contagion and, additionally, of spreading the virus to their families, friends, or colleagues . compounding the stress the protective equipment and protective procedures make medical tasks more difficult to performs (lehmann et al., ) . inconsistent with our findings, higher proportions of hcps met criteria for depression (phq- ≥ , . %) and anxiety (gad- ≥ , . %) were reported among health care workers in hospitals, in china, (lai et al., ) . the substantially lower proportions among online consulting hcps may indicate less use of online counseling among this group (j. shi et al., ) . yao and colleagues (yao, chen, & xu, ) expressed concern about online mental health services and mental health service utilization in china during the covid- epidemic, based a survey of participants with high acute stress during the epidemic, among whom only . % had ever used mental health services since the outbreak. in the current study, many participants ( %) reported subjective benefit and a desire for additional online mental health services after the interventions. nevertheless online mental health services are being used increasingly during the covid- epidemic and are facilitating the development of mental health services across china more generally (kang et al., ) , despite the lack of experimental evidence of their effectiveness (yao et al., ) . this study has several limitations. first, it used a cross-sectional observational design with a small sample size and thus could not address the long-term psychological outcomes of treatment provided to this population. second, the questionnaires were self-administered and information provided on symptoms was not verified by trained professional raters. finally, the lack of comparison from a non-online consulting group limits the generalizability of the findings. despite the above limitations, this study found that health care professionals working in the icus or respiratory department experienced more psychological distress than the others during the covid- outbreak. psychological interventions to promote mental well-being in health care professionals exposed to covid- are necessary and urgent needed. online mental health services may only catch the less severe cases. the psychological health status of frontline health care professionals during the covid- outbreak deserves attention and maybe well-served by online mental health services. while online mental health services were widely provided during the pandemic the effectiveness and barriers to utilization of this service need further evaluation. burnout and health among critical care professionals: the mediational role of resilience epidemiological and clinical characteristics of cases of novel coronavirus pneumonia in wuhan, china: a descriptive study a multinational, multicentre study on the psychological outcomes and associated physical symptoms amongst healthcare workers during covid- outbreak strengthening icu health security for a coronavirus epidemic impact on mental health and perceptions of psychological care among medical and nursing staff in wuhan during the novel coronavirus disease outbreak: a cross-sectional study the phq- factors associated with mental health outcomes among health care workers exposed to coronavirus disease ebola and psychological stress of health care professionals progression of mental health services during the covid- outbreak in china study ofthe mental state ofmedical staff and its risk factors during covid- pandemic psychometric properties of the chinese version of the perceived stress scale in policewomen validation and standardization of the generalized anxiety disorder screener (gad- ) in the general population end-of-life decisions and care in the midst of a global coronavirus (covid- ) pandemic. intensive crit care nurs intensive care management of coronavirus disease (covid- ): challenges and recommendations eta squared and partial eta squared as measures of effect size in educational research disparities in mental health care utilization among inpatients in various types of health institutions: a cross-sectional study based on ehr psychological depletion in physicians and nurses exposed to workplace violence: a cross-sectional study using propensity score analysis timely mental health care for the novel coronavirus outbreak is urgently needed. the lancet the epidemiological characteristics of an outbreak of novel coronavirus diseases (covid- ) in china rethinking online mental health services in china during the covid- epidemic table . demographic characteristics, and self-reported symptoms of health care professionals from icus/ respiratory medicine vs none. key: cord- -jpy ph authors: huang, zhifeng; zhuang, donglin; xiong, bing; deng, david xingfei; li, hanhua; lai, wen title: occupational exposure to sars-cov- in burns treatment during the covid- epidemic: specific diagnosis and treatment protocol date: - - journal: biomed pharmacother doi: . /j.biopha. . sha: doc_id: cord_uid: jpy ph epidemic prevention and control measures for the new coronavirus disease (covid- ) has achieved significant results. as of april , , infection cases of covid- among healthcare workers from countries had been reported to who. covid- has strong infectivity, high transmission speeds, and causes serious infection among healthcare worker. burns are an acute-care condition, and burn treatment needs to be initiated before covid- infection status can be excluded. the key step to infection prevention is to identify risk points of infection exposure, strengthen the protection against those risk points, and formulate an appropriate diagnosis and treatment protocol. following an in-depth study of the latest literature on covid- diagnosis and treatment, we reviewed the protocols surrounding hospitalization of patients with extensive burns (area≥ %) in our hospital from february to february and, in accordance with the epidemiological characteristics of covid- , developed an algorithm for protection during diagnosis and treatment of burns. therefore, the aspects of medical protection and the diagnosis and treatment of burns appear to be particularly important during the prevention and control of the covid- . this algorithm was followed for patients who received emergency treatment in february and were hospitalized. all healthcare worker were protected according to the three-tiered protective measures, and there was no nosocomial infection. during the covid- epidemic, the early stages of emergency treatment for patients with extensive burns requiring the establishment of venous access for rehydration, endotracheal intubation or tracheostomy, wound treatment, and surgery are the risk points for exposure to infection. the implementation of effective, appropriate-grade protection and formulation of practical treatment protocols can increase protection of healthcare worke and reduce the risk of covid- infection exposure. since december , a new type of coronavirus has continued to spread throughout the country [ ] [ ] . globally, nearly . million confirmed cases of covid- have now been reported to the world health organization (who) , and more than , deaths [ ] .after initial virus-typing tests, the who officially named the new coronavirus causing the wuhan pneumonia epidemic the " new coronavirus (sars-cov- )" on january . and the international committee on taxonomy of viruses (ictv) announced an official nomenclature of the new coronavirus (sars-cov- ) as the severe acute respiratory syndrome coronavirus (severe acute respiratory syndrome coronavirus , sars-cov- ). on the same day, the who announced that the official name of the disease caused by the virus is coronavirus disease (covid- ) [ ] . on january , china's "national infectious diseases law" was amended to make covid- a class b notifiable disease and the management of a class a infectious diseases has been adopted [ ] . a who-china joint mission shared findings and recommendations on february , j o u r n a l p r e -p r o o f wherein , cases of covid- was reported from among medical staff in medical institutions in china, of whom died [ ] . as of april , , infection cases of covid- among healthcare workers from countries had been reported to who [ ] . these data show that covid- has strong infectivity, high transmission speed, and can cause serious infections among healthcare worker. burns are an acute-care condition, and the treatment of patients with extensive burns poses a race against the time. therefore, burn treatments need to be initiated before covid- infection status can be excluded. the key step is to identify the risk points of infection exposure, strengthen the protection against those risk points, and formulate an appropriate diagnosis and treatment process. improper protection can easily lead to the occurrence of medical infections. therefore, the aspects of medical protection and the diagnosis and treatment of burns appear to be particularly important during the prevention and control of the covid- . to found the identify risk points of infection exposure, strengthen the protection against those risk points, and formulate an appropriate diagnosis and treatment protocol. following an in-depth study of the latest literature on covid- diagnosis and treatment, we reviewed the protocols surrounding hospitalization of patients with extensive burns in our hospital and, in accordance with the epidemiological characteristics of covid- , developed an algorithm for protection during diagnosis and treatment of burn patients. from to february , we reviewed and analyzed the treatment conditions and protocols followed in patients with (area≥ %) burns patients guangdong provincial people's hospital. to risk points of infection exposure during burn treatment according to the epidemiological characteristics of covid- , we obtained patient data, including the sex, age, diagnosis, admission time, operation time, endotracheal intubation or tracheotomy operation, central vein puncture operation, anesthesia mode, etc., from the medical records department of the hospital. laboratory confirmation of the sars-cov- was achieved through the concerted efforts of the guangdong center for disease prevention and control (cdc)，guangzhou ardent clinical laboratory. the rt-pcr assay was conducted in accordance with the protocol established by the world health organization [ ] . quantitative variables were expressed as mean±sd whereas qualitative variables were presented as frequencies. the chi-square or fisher's exact test was carried out for data analysis. a p-value < . was considered statistically significant. . . . source of infection: the source of infection seen so far is mainly patients with new type of coronavirus infection. asymptomatic infection can also be a source of infection [ ] . . . . route of transmission: respiratory droplets and close contact transmission are the main transmission routes. it is possible to propagate through aerosols when exposed to high concentration aerosols for a long time in a relatively closed environment. because novel coronavirus can be isolated from feces and urine, attention should be paid to the spread of aerosols or contacts caused by environmental pollution [ ] . the incubation period is - days, and is frequently - days. the main symptoms are fever, fatigue, and dry cough. a few patients have symptoms such as nasal congestion, runny nose, sore throat, and diarrhea. severe patients often develop dyspnea and/or hypoxemia week after disease onset and progress rapidly to acute respiratory distress syndrome (ards), septic shock, refractory metabolic acidosis, and coagulopathy. notably, the course of severe and critically ill patients can be marked by moderate to low fever, or they may even be afebrile. mildly affected patients show only low fever and mild fatigue without symptoms of pneumonia. judging from the current cases, most patients have a good prognosis, and a few patients do become critically ill. the prognosis for the elderly and patients with chronic underlying disease is poor. fortunately, symptoms in children are relatively mild. the peripheral white blood cell count in patients with early onset was normal or decreased, the lymphocyte count was normal or decreased, and some patients had elevated liver enzymes, muscle enzymes, and myoglobin; some critically ill patients showed increased troponin levels. in most patients, c-reactive protein and erythrocyte sedimentation rate (esr) increased, and procalcitonin level was normal. in some patients, d-dimer increased and peripheral blood lymphocyte decreased progressively. most severe and critically ill patients present showed elevated levels of inflammatory factors. sars-cov- was detected by reverse transcription polymerase chain reaction (rt-pcr) and/or next-generation sequencing (ngs) in nasopharyngeal swabs, sputum and other lower respiratory secretions, blood, and feces. the virus was more accurately detected in lower respiratory tract samples (sputum or airway extracts). samples were sent for examination as soon as possible after j o u r n a l p r e -p r o o f collection. most of the specific immunoglobulin m (igm) antibodies of sars-cov- began to test positive - days after disease onset. the titer of igg antibody in the recovery period was times higher than that in the acute period. in the early stages, there were multiple, small, patchy shadows and interstitial changes on imaging, especially in the lateral zone of the lung. later on, patients developed multiple ground-glass shadows and infiltrates in both lungs. in severe cases, lung consolidation may occur, although pleural effusion is rare. any one of the epidemiological histories with any two of the clinical manifestations, or three of the clinical manifestations without epidemiological history are suspected cases. details of the epidemiological history and clinical manifestations in patients with suspect covid- are presented in table . suspected cases were diagnosed as confirmed cases based on one of the following evidences: a. laboratories" [ ] , and developed an algorithm for the protection of healthcare worker during burn treatment. the above protective measures and treatment processes were carried out for patients who required emergency treatment in february and were hospitalized ( table ) . during the covid- epidemic, requirements for medical staff protection and a diagnosis and treatment flowchart for burn treatment were formulated ( table ) . as of february , the abovementioned protective measures and procedures were implemented for patients suspected of covid- infection in the emergency department. one patient was diagnosed as an asymptomatic carrier of the covid- virus and was treated in the negative-pressure ward of the infectious diseases department. two patients were suspected cases of covid- and needed to be isolated for days. ct examination of lung and tests for sars-cov- nucleic acid examination were negative when tested at two different timepoints. after the covid- infection was ruled out, two patients were j o u r n a l p r e -p r o o f transferred back to the burn ward. one patient was considered free of covid- infection and received treatment in the burn ward ( table ) . during the diagnosis and treatment of all four patients, all the healthcare worker carried out protective measures according to the three-level protection requirements, without contracting nosocomial infection. sars-cov- is highly infectious and pathogenic. covid- is a new and sudden acute infectious disease that can be spread through person-to-person transmission. at present, covid- has no significant known curative treatment. after the virus invades the human body, it mainly destroys the respiratory tract and causes pneumonia, which may lead to respiratory failure and endanger life [ ] [ ] [ ] . in wang's paper, as of january , of the patients with covid- in a general hospital at wuhan, ( . %) were presumed to have been infected in the hospital, including patients ( . %) who were already hospitalized for other reasons and healthcare workers ( %). of the infected healthcare workers, ( . %) worked in the general wards, ( . %) in the emergency department, and ( %) in the icu [ ] . more than healthcare workers in the surgical department were presumed to have been infected by the first covid- patient. patient-to-patient and healthcare-worker-to-healthcare-worker transmission was presumed to have occurred. therefore, the general department, especially the surgical department, is a department with high incidence of infection among healthcare worker in medical institutions in china were reported, of which died [ ] . as of april , , infection cases of covid- among healthcare workers from countries had been reported to who [ ] .these data show that covid- has strong infectivity, high transmission speed, and can cause serious infection among healthcare worker. the lack of covid- research in the early stages of the disease is one reason for healthcare worker to have neglected protection. in the middle stage of the disease, it was confirmed that covid- is transmitted through respiratory droplets, close contact, and aerosol transmission. however, due to a large number of patients beyond wuhan's urban medical allocation, the supply of medical protective materials is seriously insufficient, which leads to the continuous occurrence of nosocomial infections [ ] . in fact, a large number of healthcare worker infected in a short period easily increase the work pressure and psychological pressures on other healthcare worker. therefore, it is very important to identify the risk points of infection exposure, strengthen the protection of healthcare worker, and develop a standard protocol for the diagnosis and treatment. patients with extensive burns need to receive a large amount of fluid resuscitation after being the function of the skin barrier is destroyed in patients with extensive burns, which leads to wound exposure and wound exudation. early treatment requires topical drugs and wound dressings. this fever is common in patients with extensive burns. combined with respiratory tract burns, the patient can progress to have lung and bronchial injury. because of systemic inflammatory response syndrome and large amount of rehydration treatment, burn patients are prone to pulmonary edema. x-ray examination of both lungs in burn patients showed multiple, small, spots and interstitial j o u r n a l p r e -p r o o f changes. this is very similar to the early chest-imaging findings of covid- . therefore, it is not easy to differentiate and diagnose the two conditions clinically. in our study, cases of large area burns were treated in emergency, cases were febrile, and case had multiple, small, spots on chest imaging. quickly complete lung ct and blood routine examinations for new patients who are admitted to the emergency ward and screening, based on a new covid- -infected pneumonia diagnosis and treatment plan (trial version ) , should be combined with clinical symptoms and epidemiological history. healthcare worker should establish secondary protective measures. as all new patients are routinely admitted to the emergency ward or the emergency icu for regional isolation, the departmental healthcare worker should take primary protections. if it is necessary to perform invasive procedures in these patients, healthcare worker should undertake secondary protection. for the suspected or confirmed ncp patients, healthcare worker should strictly follow the emergency treatment plan, and promptly seek a consultation with an infectious diseases specialist, modify the treatment plan, and transfer the patient to the infectious diseases specialized ward. in cases where patients need to be treated with close contact, healthcare worker need to establish tertiary protection (figure ). patients with extensive burns are prone to anasarca or neck edema leading to tracheal compression stenosis. when combined with respiratory burns, damage to airway mucosa, and tracheal edema, there is an increased possibility of asphyxia. intubation or tracheostomy is often needed during early treatment in these patients. in this study, burn patient needed endotracheal intubation and ventilator-assisted ventilation. related literature suggests that medical procedures, such as endotracheal intubation, tracheotomy, mechanical ventilation, and fiberoptic bronchoscopy, can increase the risk of sars-cov and mers-cov transmission [ ] . therefore, according to the requirements of the who "infection prevention and control during health care when novel coronavirus (ncov) infection is suspected" interim guidance and the opinions of the clinical expert committee, healthcare worker need to undertake tertiary protection (including hand hygiene, use of personal protective equipment, respiratory hygiene, needlestick prevention, cleaning of medical supplies, and treatment of medical waste, etc.) for suspected/confirmed patients of covid- , droplet isolation and contact isolation are required, and air-isolation measures need to be undertaken for medical procedures that can generate aerosols [ ] . for patients who have not been confirmed free of covid- infection, medical procedures can be carried out in the negative-pressure ward; alternatively, these procedures can be conducted in a well-ventilated ward to avoid operations in the positive-pressure ward. the authors declare that there are no conflicts of interest. age and operation. in each area group of large burns, the number of men was more than that of women as jobs that men undertake may be more likely to cause burns than the jobs that women carry out. "+"required; "-"not required (except for exceptional circumstances); "±"use as needed; "/"insufficient protection; "+ *"protective products for selective use / simultaneous use according to the actual conditions of medical institutions. "general diagnosis and treatment": this refers to non-aerosol-generating operations(aerosol-generating operations include sputum suction, respiratory tract, and endotracheal intubation). c. patients with fever or respiratory symptoms from wuhan and surrounding areas, or from communities with reported cases within days preceding illness onset. d. aggregation onset (two or more cases of fever and/or respiratory symptoms within the preceding weeks in small areas, such as family, office, school class) a. fever and/or respiratory symptoms b. with the above imaging characteristics of pneumonia c. total number of white blood cells normal or decreased, or normal or decreased lymphocyte count in early-stage disease. any one of the epidemiological histories with any two of the clinical manifestations, or three of the clinical manifestations without epidemiological history are suspected cases j o u r n a l p r e -p r o o f china novel coronavirus investigating and research team, a novel coronavirus from patients with pneumonia in china another decade, another coronavirus world health organization. who director-general's opening remarks at the media briefing on covid- - severe acute respiratory syndrome-related coronavirus -the species and its viruses, a statement of the coronavirus study group national health commission of the people's republic of china, announcement of the national health committee of the people's republic of china world health organization. who-china joint mission shares findings and recommendations world health organization world health organization. coronavirus disease (covid- )situation report - world health organization. laboratory diagnostics for novel coronavirus national health commission of the people's republic of china, interpretation of clinical data on hospital environmental hygiene monitoring and medical staffs protection during the coronavirus disease outbreak, biorxiv regulation for prevention and control of healthcare associated infection of airborne transmission disease in healthcare facilities a familial cluster of pneumonia associated with the novel coronavirus indicating person-to-person transmission: a study of a family cluster clinical features of patients infected with novel coronavirus in epidemiological and clinical characteristics of cases of novel coronavirus pneumonia in wuhan, china: a descriptive study clinical characteristics of hospitalized patients with novel coronavirus-infected pneumonia in the novel coronavirus pneumonia emergency response epidemiology team, the epidemiological characteristics of an outbreak of novel coronavirus diseases (covid- characteristics of and important lessons from the coronavirus disease for disease control and prevention isolation of a novel coronavirus from a man with pneumonia in saudi arabia world health organization. infection prevention and control during health care when novel coronavirus (ncov) infection is suspected (interim guidance) key: cord- -h ccksm authors: bar-lev, shirly; beimel, dizza title: numbers, graphs and words – do we really understand the lab test results accessible via the patient portals? date: - - journal: isr j health policy res doi: . /s - - -z sha: doc_id: cord_uid: h ccksm background: the heavy reliance on remote patient care (rpc) during the covid- health crisis may have expedited the emergence of digital health tools that can contribute to safely and effectively moving the locus of care from the hospital to the community. understanding how laypersons interpret the personal health information accessible to them via electronic patient records (eprs) is crucial to healthcare planning and the design of services. yet we still know little about how the format in which personal medical information is presented in the epr (numerically, verbally, or graphically) affects individuals’ understanding of the information, their assessment of its gravity, and the course of action they choose in response. methods: we employed an online questionnaire to assess respondents’ reactions to medical decision-making scenarios, where the same information was presented using different formats. in each scenario, respondents were presented with real (anonymized) patient lab results using either numeric expressions, graphs, or verbal expressions. participants were asked to assess the gravity of the hypothetical patient’s condition and the course of action they would follow if they were that patient. the questionnaire was distributed to more than participants, of whom submitted usable responses. results: laypersons were more likely to overestimate the gravity of the information when it was presented either numerically or graphically compared to the narrative format. high perceived gravity was most likely to produce an inclination to actively seek medical attention, even when unwarranted. “don’t know” responses were most likely to produce an inclination to either search the internet or wait for the doctor to call. policy recommendations: we discuss the study’s implications for the effective design of lab results in the patient portals. we suggest ( ) that graphs, tables, and charts would be easier to interpret if coupled with a brief verbal explanation; ( ) that highlighting an overall level of urgency may be more helpful than indicating a diversion from the norm; and ( ) that statements of results should include the type of follow-up required. the heavy reliance on remote patient care (rpc) during the covid- health crisis may have expedited the use of digital health tools to safely and effectively move the locus of care from the hospital to the community, and even the home [ , ] . enthusiasts see this as a longoverdue opportunity to reengineer care processes so as to reap the full benefits of health information technologies [ ] . health information technologies (hit) are broadly defined as "the electronic systems that health care providers and increasingly, patients, use to store, share and analyze information" [ ] . direct patient use of test data is consistent with trends toward patientcentered care and the medical home concept, which aims to achieve greater patient involvement in both medical decision making and health self-management [ ] . these care approaches expect the "digitally engaged patient" to self-monitor and self-care for themselves and their families through the skillful use of enhanced digital technologies [ ] (see also [ ] [ ] [ ] [ ] [ ] ). yet managing their own health has been shown to place heavy demands on laypersons, who are now expected to correctly interpret their test results, evaluate the pros and cons of different treatments, and decide on a preferred course of action [ , ] . correspondingly, clinicians have expressed concern that patients often experience great difficulty in comprehending, interpreting, and correctly responding to personalized health information, partly due to inappropriate presentation of the information in patient portals [ , ] . in particular, misunderstanding test results leads to confusion, frustration, and disruptions in healthcare processes, including delays in seeking care, overutilization of services, medication errors, and inappropriate healthcare decision-making [ , , ] . a stream of evidence shows that laypersons differ from experts in how they assess the meaning of healthcare information and evaluate its trustworthiness [ ] [ ] [ ] [ ] . for instance, in the case of antenatal screening tests, practitioners tend to frame risk information numerically, as the probability of a genetic condition, even though laypersons display a better understanding of the information when a verbal or narrative format is used [ ] . yet patients are more likely to take up genetic testing when presented with numeric risk information [ , , ] . compared with medical professionals, laypersons are more readily influenced by the attractiveness of a site's design and have even been found to reject highquality content because of poor visual design, confusing displays, and a low density of relevant information [ , ] . since laypersons can and often do view the results of their check-ups and medical tests prior to interacting with their healthcare providers, the meaning they attach to these results can significantly affect their decisionmaking and subsequent follow-up care. recent definitions of e-health literacy consider the set of individual capacities that allow the person to acquire and use new information, as well as the cognitive competencies required to make judgments and decisions in everyday life concerning health [ , ] . e-health literacy has been shown to combine knowledge and skills from a wide variety of domains, and is inherently contingent upon the social contexts wherein it is developed and expected to be put into use. as a result, it can be affected by a variety of personal and socio-demographic factors, including age, gender, education, acute and chronic health concerns, general health literacy, and technological proficiency [ , ] . however, it is still difficult to assess whether people's interpretation of information such as test results is more affected by these socio-demographic variables, or by how the information is displayed. thus, the first aim of the present study is to help address this gap by examining respondents' interpretation of medical information while controlling for various demographic characteristics (age, education level, socio-demographic status, health status, attitudes towards self-care, and responsiveness to medical or health recommendations). the present research is also motivated by the fact that despite growing interest in laypersons' comprehension and use of medical knowledge to reach appropriate medical decisions, little is still known of the extent to which different visual displays help people discriminate between test results that do or do not require urgent action [ , , , ] . zikmund-fisher et al. [ ] asked their participants to imagine that they were viewing the results of a set of blood tests on an online patient portal. they varied the format in which participants viewed these test resultsas a number line graph, a table, or raw numbersand tested the relationship between the display format and respondents' perceptions of urgency and inclination to contact health care providers. they found that when test results were abnormal (indicated extreme values), perceived urgency was universally high, regardless of which display format was shown. however, perceptions regarding near-normal values varied substantially across formats. the pattern they found was consistent: participants who saw their near-normal values in a tabular display rated those results as most urgent, while those who saw a gradient line display perceived the results as least urgent. the authors attributed these differences in interpretation to both the amount of information conveyed by each format, and to the cognitive skills each format requires to deduce the bottom-line implications of the information. thus, the second aim of the present study is to test whether the findings of zikmund-fisher et al. [ ] are conceptually replicated in a different sample and study design. following zikmund-fisher et al. [ ] , we examine three aspects of knowing related to the interpretation of lab test results in patient health portals: knowing, uncertainty, and accuracy. knowing is defined here according to the standard dictionary definition, as a perception of clear and certain mental apprehension. uncertainty is defined as a cognitive claim of insufficient knowledge, or a lack of understanding regarding the meaning of the information presented [ , ] . accuracy is defined as a condition or quality of being correct or exact with relation to a standard, again based on the standard dictionary definition. more concretely, we examine how different displays of information were related to different interpretations of severity, "do not know" answers and inaccuracies in judgment. we propose three hypotheses: h : the three information formats (verbal, numeric, and graphic) will differ in the accuracy of participants' assessments. h : the three information formats (verbal, numeric, and graphic) will yield different levels of uncertainty with regard to the condition's level of gravity. h : the higher the perceived gravity of the health condition, the more proactive people are likely to be in seeking help or information. the conceptual model which forms the basis for the hypotheses is displayed in fig. . we employed a survey to assess respondents' reactions to medical decision-making scenarios, where the same information was presented using different formats. in each scenario, respondents were presented with real (anonymized) patient lab results using either numeric expressions, graphs, or verbal expressions. participants were asked to assess the gravity of the hypothetical patient's condition and the course of action they would follow if they were that patient. participants were recruited through convenience sampling, mainly via the authors' networks. this sampling method is commonly employed in healthcare-related surveys [ ] [ ] [ ] . each respondent was asked to virally distribute the link to others in their network (snowball sampling). the link was operative for a period of weeks, and we monitored the response rate daily. by the end of the data collection period the link had been distributed to over individuals. we used all valid responses obtained. that is, rather than trimming or imputing, we worked with different sample sizes for each analysis, calculating the means for each respondent where necessary. in total, participants returned questionnaires suitable for analysis, meaning they responded to at least some of the scenarios, and returned fully complete questionnaires. approximately % of those who began the survey (i.e., who completed the demographic questions) submitted usable answersa satisfactory percentage, given that the questionnaire was relatively long and contained different scenarios. figure describes our missing values policy in detail. missing data analysis revealed that missing values were random for most variables a pearson chi-square test showed that those who did not complete the questionnaire differed from those who did in three demographic variables: income (x ( , n = ) = . value, p = . ), and family status (x ( , n = ) = . value, p < . ). an independent t-test revealed that those who did not complete the questionnaire were significantly older (m = . ; std. = . ) than those who did (m = . , std. = . ) f = . , p = . ). these differences are consistent, meaning that those who did not provide usable responses were significantly older, had slightly higher incomes, and were married. no differences were found in health status. finally, we applied a binomial test of equal proportions or two-proportion z-test to determine the minimum required sample size. in this study, a random sample of pairs (where the mean difference is . and the standard deviation of the difference is . ) would allow us to declare with % power that the mean of the paired differences is significantly different from zero (i.e., a two sided p-value is less than . ). the sample size of this study is , for version a and for version bcomfortably above pairs (see table ). participants were randomly assigned to receive one of two versions of the questionnaire. both versions contained the same scenarios and questions, differing only in the presentation of the test results. of the surveys which contained usable responses, represented the first version of the survey, and the second. for each scenario, two of the three formats were contrasted between the two versions (i.e., sometimes verbal vs. graphic, sometimes graphic vs. numeric, etc.; see under "procedure and materials" below). an independentsamples t-test showed no differences in demographic measures between respondents who received the two versions of the questionnaire (see table ). using qualtrics software we produced anonymized links to the two versions of the survey, each containing medical decision-making scenarios. the order of the scenarios was the same in both versions. in each scenario, respondents were presented with lab results relating to important but non-life-threatening health conditions using either numeric expressions, graphs, or verbal expressions. participants were asked to assess the gravity of the hypothetical patient's condition and the course of action they would follow if they were that patient. the lab tests (blood work or cultures) were extracted from authentic patient portals, and had been ordered to investigate or test for one of the following: erratic menstrual cycles; low hemoglobin; hepatitis b; streptococcus (a throat infection); or a routine cholesterol check. these conditions and tests were chosen because they are relatively common, likely to be only moderately serious, and in most cases potentially applicable to both men and women. each scenario contained a short description of the patient's symptoms and the possible consequences of poor treatment. two physicians, both of them general practitioners working both in the community and hospitals, independently reviewed the scenarios and confirmed the accuracy and reliability of the information provided. an example of one scenario is shown in fig. . after reading the scenarios and viewing the results, participants were asked to assess the gravity of the condition, and what course of action they would recommend for the patient. our aim was not to test our participants' medical proficiency or knowledge, but solely their interpretation of the lab results presented to knowing. after reading each scenario, participants were asked to assess the gravity of the hypothetical health condition, based on the results of the lab tests provided. perceived gravity ranged from = very low to = very high, with = don't know. knowing was operationalized as any response from to (as opposed to , meaning "don't know"). uncertainty was operationalized as a choice of the sixth option in the gravity scale, namely "don't know." a choice of the "don't know" response indicated that the participant had difficulty interpreting the lab results. accuracy, the quality of being correct with respect to a standard, was also measured in relation to responses on the gravity scale, and was operationalized by comparing all responses of to against the physicians' assessment of the gravity of the health condition. we were thus able to assess who underestimated the gravity of the condition, who correctly assessed the gravity of the condition, and who overestimated the gravity of the condition. this variable ranged from − . to . . we then turned this into a categorical variable named level of accuracy (> = ; = ; < = ). for each scenario, we asked participants to indicate how likely they would be, if they were the patient, to do each of the following upon seeing the presented lab results: . immediately contact their doctor; . search out more information on the internet; . wait for their physician to contact them; and . wait until their next visit to the doctor to verify the meaning of the results. for each course of action, respondents were asked their likelihood of taking that path on a -point scale, where = very unlikely and = very likely. demographic measures collected were age, gender, hmo membership, income, education, religiosity, family status, and country of birth (see table ). to offset differential response rates by age, we divided the descriptive statisticsdemographics, health status, health behaviors, and epr use [ ] . our sample underrepresents haredi and religious participants, as well as other minority groups. the limitations of the chosen sampling method will be discussed later in the paper. based on the full sample, % of our respondents claimed to be in poor health, while % reported being in good, very good or excellent health. fifty-five respondents ( %) reported suffering from a chronic illness, and respondents ( %) reported suffering from some type of physical limitation. being in good or very good health was negatively correlated with age (r [ ] = − . , p < . ). age was positively correlated with feeling responsible for one's health (r [ ] = . , p < . ), and negatively correlated with postponing regular checkups (r [ ] = − . , p < . ). most indicated that they felt responsible for keeping healthy (m = . , std. = . , on a -point scale where = strongly disagree, = strongly agree) and that maintaining a healthy lifestyle was important to them (m = . , std. = . ; = strongly disagree, = strongly agree). they also reported generally complying with their doctor's recommended regime (m = . , std. = . ). when asked how they respond when they feel sick, % of the respondents who answered this question (n = ) said they turn to their doctor for a consultation, while % (n = ) turn to a family member, . % (n = ) consult medical websites for information, and only . % (n = ) consult online health forums. with respect to epr use, % of our participants (n = ) reported that they frequently access their lab results via the epr. ten percent (n = ) claimed to have never viewed their lab results via the epr, and an additional . % (n = ) of our participants were not aware of being able to view their lab results via the epr. in general, women tend to use the epr significantly more than men (t [ ] = − . , p < . ). however, these differences disappear when focusing on use of the epr to view lab results and health recommendations (i.e., women more than men use the epr for administrative purposes such as scheduling doctors' appointments and filing requests for prescription drugs for themselves and other family members). there was a significant main effect of age on epr use, f ( , ) = . , p < . . participants aged - were significantly less inclined to consult the epr than those aged - and those aged + (p < . ). h : the three information formats (verbal, numeric, and graphic) will differ in the accuracy of participants' assessments. in general, both the participants and the physicians interpreted the conditions as mildly serious or not very serious. a wilcoxon signed-rank test showed that physicians' assessments of gravity were significantly lower than those of the laypersons (z = − - . , p = . ). a follow-up pearson chi-square test confirmed these differences (chi-square, . , df = , p < . ). the results suggest that the participants were fairly accurate in the general trend, but tended to overestimate the conditions' gravity in all three formats (see fig. -participants' and experts' assessments of gravity, for each information format). looking dipper, a paired sample t-test revealed that accuracy is higher when results are explained verbally, rather than having a number stand on its own (see table ). accuracy is greater when a numeric value appears in tabular form, as opposed to only a value. and overall, accuracy is greater when results are presented in a tabular form, rather than in a line graph, even though both represent deviations from the norm. finally, we examined whether accuracy can be explained by demographic variables or participants' general health status and familiarity with epr use. results of a multiple linear regression to predict level of accuracy point to a collective significant effect of gender, age, education, health status, income, epr use, and uncertainty (f ( , ) = . , p < . , r = . ). however, only age (beta = . ; t = − . , p = . ), and uncertainty (beta = −. ; t = − . , p < . ) were significant predictors in the model. a one-way anova revealed differences between the three age groups with regard to accuracy (f ( , ) = . , p = . ). a tukey post-hoc test revealed that accuracy was significantly lower among those aged - (m = . ; std. = . ; p = . ) than among those aged - (m = . , std. = . , p = . ) and those aged + (m = . , std. = . , p = . ). no significant differences were found between those aged - and those years old and older. these findings suggest that age-related familiarity with different health conditions could be related to accuracy. h : the three information formats (verbal, numeric, and graphic) will yield different levels of uncertainty with regards to being able to assess the condition's level of severity. we measured the proportion of respondents who chose the "don't know" response for any of the scenarios. slightly more than half ( . %) chose the "don't know" option at least once. of those, only % chose the "don't know" response in more than eight scenarios. these findings indicate that the "don't know" option was generally not chosen automatically, and without reflection. figure shows the percentage of respondents who chose the "don't know" response in each of the scenarios. figure demonstrates the proportion of "don't know" responses for each scenario, and level of accuracy. the graph reveals no discernable association between either "don't know" responses or accuracy and health condition, leading us to believe that the display of information plays an important role in both. the only visible exception relates to levels of progesterone (scenarios and ). in both scenarios the rate of "don't know" responses is relatively high, and the level of accuracy is relatively low, compared to all other scenarios. we hypothesized that gender and age could explain these findings, and conducted two separate two-way anovas to examine the effect of gender and age on accuracy and on "don't know" responses in those two scenarios. however, no statistically significant main effects nor interaction were found. more generally, we performed a hierarchical linear regression to predict the level of "don't know" responses based on various demographic variables (age, gender, education, family status, and income), along with epr use and health status. variables were entered into the equation using the stepwise method. these variables explained a relatively small proportion of variance in uncertainty scores ("don't know" responses). in the first model, r = . , f ( , ) = . , p < . . in the second model, r = . , f ( , ) = . , p < . . in the first model, income alone significantly predicted uncertainty scores, b = . , t ( ) = . , p < . . in the second model, both income, b = . , t ( ) = . , p < . , and gender, b = . , t ( ) = . , p < . , significantly predicted uncertainty scores. we then conducted a hierarchical linear regression to predict the level of accuracy based on demographic variables (age, gender, education, and income), along with epr use and health status. variables were entered into the equation using the stepwise method. in the first model, income significantly predicted accuracy, b = . , t ( ) = . , . these findings suggest that women more than men, and those of higher versus lower income, indicated that they could not assess the conditions' gravity based on the information displayed. however, those who did were more accurate than those who were younger and of lesser means. gender had no effect on accuracy, suggesting that women were more comfortable indicating that they were unsure of the answer than the men participating in the study. we then performed a one-way between-subjects anova to compare the effect of information format on "don't know" responses. we found a significant effect of format type on "don't know" responses, f ( , ) = . , p = . . post hoc comparisons using the tukey hsd test show that the mean score for the graph condition (m = . , std. = . ) is significantly lower than that for the numeric condition (m = . , std. = . ), and also lower than the mean score for the verbal condition (m = . , std. = . ). on average, the numeric format produced the highest number of "don't know" responses and the graphic format the least, indicating that respondents found the numeric format most difficult to understand and the graphic format the easiest. these findings confirmed our hypothesis that the three information formats differ in the ease with which they were understood. yet as reported earlier, those participants who assessed the gravity of the health conditions were slightly but significantly more accurate when results appeared in a table, than in the line graph format, even though in both appeared a scale showing normal and abnormal results (see fig. ). h : the higher the perceived gravity of the health condition, the more proactive people are likely to be in seeking help or information. first, we performed a linear regression to predict the level of proactivity based on various demographic variables (age, sex, education, family status, having children under the age of , and income), and perceived gravity of the health condition. variables were entered into the equation using the stepwise method, starting with perceived gravity and then adding the control variables one by one. two models were found significant. in the first model, the only independent variable to predict level of proactivity was perceived gravity of the health condition, f ( , ) = . , p < , r = . . in the second model, income was found significant in addition to gravity, f ( , ) = . , p < , r = . . we conducted a one-way between-subjects anova to compare the effect of information format on prefered course of action. interestingly, we found that information format had a significant effect only on respondents' tendency to choose "search the internet" as a preferred course of action, f ( , ) = . , p < . . . in post hoc comparisons using the lsd test, the mean score for the numeric condition (m = . , std. = . ) was significantly higher than for the verbal condition (m = . , std. = . ). no significant difference was found between the numeric condition and the graph condition (m = . , std. = . ). this finding is congruent with our earlier finding that the numeric format produced the highest number of "don't know" responses and the graphic format the least, suggesting that respondents found the numeric format hardest to understand and the graphic format the easiest. we assume that our respondents expected that searching the internet would clarify the situation. interestingly, however, the graphic presentation, which supposedly offers the greatest amount of contextualized information, also precipitated relatively high scores for internet search, perhaps because of its complexity. finally, we expected that those who did not understand the information ("don't know" responses) would favor more proactive measures, defined as immediately contacting their doctor or searching for information on the internet. a pearson correlation revealed an inverse relationship between "don't know" responses and participants' tendency to call a doctor (r = − . , p < ), and a positive relationship between "don't know" and the other three courses of action: searching the internet (r = . , p < ), waiting for the doctor to call them (r = . , p < . ), or waiting for their next visit to the doctor (r = . , p < . ). thus, the less understandable the information presented, the less likely the participants were to immediately call their family doctors. rather, they were more likely to search the internet for information, wait for their next doctor's appointment, or wait for their doctor to contact them. consulting the internet for information was positively correlated with waiting for the doctor to call and waiting for one's next visit to the doctor (r [ ] = . , p < . ; r [ ] = . , p < . , respectively). thus, our hypothesis was not supported (see table ). it has been shown that engaged patientsthose who actively seek to know more about and manage their own healthare more likely than others to participate in preventive and healthy practices, self-manage their conditions, and achieve better outcomes [ ] . studies also show that engaged patients are better able to understand whether or not a result is worrisome, and what actions, if any, should be followed [ ] . in our study, respondents found the numeric format hardest to understand and the graphic format the easiest. yet they displayed a slightly higher level of inaccuracy in the graphic format, less so in the numeric, and the least in the verbal. in other words, for those respondents who hazarded a gravity assessment (as opposed to those who chose the "don't know" option), information was most difficult to interpret correctly when presented in a line graph, and easiest to interpret correctly when presented numerically (in a tabular form). however, these differences should be explored further. our findings concur with previous studies which suggest that graphs may appear as an appealing alternative to numbers because visualization allows for quick and intuitive assessment. however, some aspects of graph interpretation may require effortful cognitive skills that must be learned [ ] . formats that leave respondents less able to understand the resultsnamely, the verbal and graphic formatsproduced lower inclination to actively seek professional help. low levels of understanding (operationalized through respondents' choice of "don't know" when asked to assess the gravity of the information) were negatively correlated with an expectation of immediately calling the doctor, and positively correlated with searching the internet, waiting for the doctor to contact the patient, and waiting for one's next visit to the doctor. thus, uncertainty regarding the meaning of the lab results drove participants to shift the burden of responsibility to their doctors, as well as to delay actively seeking medical services [ , ] . as zikmund-fisher and his colleagues found in their study [ ] , high perceived gravity of the health condition was the only predictor of immediately calling the doctor. our findings suggest that age is an important predictor of both accuracy and uncertainty, indicating that familiarity with a wide range of health conditions and with the healthcare system may enhance accurate interpretation of the results. this finding is in line with the literature indicating that a broad acceptance of personal health record (phr) technology may not be related to education or income, but to the patient's health literacy [ , ] . however, the participants in this study were not required to operate the epr to elicit the test results. it is possible that low proficiency in navigating patient portals can affect older people's effective use of these technologies. a semantic approach to knowledge transfer posits that even if a common syntax or language is present, differences of interpretation can impede communication between experts and laypersons [ ] [ ] [ ] [ ] . as suggested by witteman and zikmund-fisher [ ] , patients viewing laboratory results may not care about the number itself. instead, they wish to know: "is this good or bad?" or, more personally, "am i ok?" or "do i need to do anything?" ( [ ] , p. ). moreover, simply understanding the plain meaning of medical information may not be enough to interpret the information's significance. for instance, it is rarely enough to understand the meaning of each isolated result, to truly assess the gravity of a health condition, patients need to grasp the comprehensive meaning of the results. to move patients from adherence to engagement, personalized information must be presented in a way that ensures precision of interpretation, not only informing patients, but allowing them to act on the information [ ] . and so, to engage individuals in their health, it is critical that the numbers, values, terms, and units have meaning for the person receiving them, and can easily become actionable. a well-designed results sheet can and should encourage patients to take an active role in interpreting their test results in ways that will allow them to follow up on their health. we suggest that graphs, tables, and charts could be made easier to interpret if coupled with a brief and concise verbal explanation, using language that is familiar to readers. moreover, instead of indicating a diversion from the norm, it might be more helpful to indicate an overall level of urgency, and include a recommendation for the type of follow-up required (i.e., a consultation with a doctor, more tests, or certain types of monitoring). our findings should be considered in light of the study's limitations. first, though the information presented was drawn from authentic records, our respondents encountered it in the context of hypothetical scenarios. this method has been documented in the literature on epr design (e.g., [ ] ). nonetheless, addressing hypothetical scenarios meant that the participants lacked the personal relevance that such test results have for patients attempting to manage these conditions. relatedly, we did not measure respondents' familiarity with the specific tests presented. we assumed that many of our respondents were familiar with at least some of the conditions in the scenarios, and had perhaps even managed them in the past. we also assumed that there are many scenarios in which patients with no prior knowledge of a given laboratory test might view laboratory results in a patient portal. we therefore believe that our study design successfully simulated realistic circumstances. however, it is possible that our results may not accurately reflect how people respond to their own personalized health information. future inquiries should consider further how people might interpret their own health information, using a combination of quantitative and qualitative methods. second, the sample size, and level of attrition in studies such as this need be addressed in further studies. it is possible that the length of the questionnaire and its complexity contributed to both. furthermore, despite our sample's diversity in terms of demographics, experience with the epr system and health beliefs, our research design prevented us from reaching minority groups within the israeli population, such as arabs, ultraorthodox jews, and immigrants from the former soviet union or of ethiopian or french descent. their omission from the study was partly due to methodological complications. in particular, the language used in the epr is hebrew, but for many israeli minorities hebrew is a second language. asking minority respondents to fill in the questionnaire in hebrew would have required a control for language proficiency that was beyond the scope of this study; while the alternative, translating the scenarios into russian, amharic, arabic or french, might have reduced the authenticity of the information. in the present case, we can assume that if native israelis, highly proficient in hebrew, demonstrated significant deficiencies in their comprehension of personalized medical information, members of these populations would do so as well. however, we encourage scholars to study the role of cultural and educational diversity in the interpretation of personalized health information. to further our understanding on how information presentation affects laypersons' understanding, perceptions and actions, future studies should design methodologies that can survey larger and more diversified populations. to conclude, this study makes three unique contributions. first, it is concerned not only with assessments of urgency, but with the accuracy of patients' assessments. second, it uncovers how people react when they are unsure what the results encountered in electronic records mean. third, it examines which follow-up actions laypersons are likely to take in response to their interpretation of the results. as such, the paper deals with the core problem of digitation namely, how to make medical information understandable so that it can be translated into appropriate and timely action. addressing these concerns is key to designing health information technologies that can improve laypersons' engagement and self-care, as well as reduce both under-and over-utilization of health services. authors' contributions the first author, shirly bar-lev, has made substantial contributions to the conception, design of the work; the acquisition, analysis, interpretation of data; and has drafted the work. the second author, dizza beimel, has made substantial contributions to the conception, design of the work; and the acquisition of data. the author(s) read and approved the final manuscript. digital healthcare: the only solution for better healthcare during covid- pandemic? virtually perfect? telemedicine for covid- what it will take to achieve the as-yet-unfulfilled promises of health information technology office of the national coordinator for health information technology. health it: advancing america's health care (fact sheet numeracy and literacy independently predic patients' ability to identify out-of-range test results quantifying the body: monitoring and measuring health in the age of mhealth technologies a multidisciplinary approach to designing and evaluating electronic medical record portal messages that support patient self-care despite substantial progress in ehr adoption, health information exchange and patient engagement remain low in office settings exploring factors associated with the uneven utilization of telemedicine in norway: a mixed methods study everyday and unavoidable coproduction: exploring patient participation in the delivery of healthcare services capitalizing on health information technology to enable digital advantage in us hospitals tables or bar graphs? presenting test results in electronic medical records graphics help patients distinguish between urgent and nonurgent deviations in laboratory test results presenting self-monitoring test results for consumers: the effects of graphical formats and age empirical research in on-line trust: a review and critical assessment how do patients evaluate and make use of online health information? how numeracy influences risk comprehension and medical decision making it's just a likelihood": uncertainty as topic and resource in conveying "positive" results in an antenatal screening clinic communicating risk information in genetic counseling: an observational study genetic testing likelihood: the impact of abortion views and quality of life information on women's decisions visual representation of statistical information improves diagnostic inferences in doctors and their patients health literacy and public health: a systematic review and integration of definitions and models health literacy in an israeli elderly population factors affecting compliance with use of online healthcare services among adults in israel media health literacy, ehealth literacy, and the role of the social environment in context design features of graphs in health risk communication: a systematic review varieties of uncertainty in health care: a conceptual taxonomy discourse-pragmatic variation across situations, varieties, ages: i don't know in sociolinguistic and medical interviews users' preferred interactive e-health tools on hospital web sites the e-health literacy framework: a conceptual framework for characterizing e-health users and their interaction with e-health systems patient portals as a tool for health care engagement: a mixed-method study of older adults with varying levels of health literacy and prior patient portal use council for higher education, a decade of academic excellence - , council for higher education a national action plan to support consumer engagement via e-health communicating laboratory results to patients and families the digital divide: examining sociodemographic factors associated with health literacy, access and use of internet to seek health information the impact of health literacy on a patient's decision to adopt a personal health record lost in translation? "evidence" and the articulation of institutional logics in integrated care pathways: from positive to negative boundary object? sociol health illn a pragmatic view of knowledge and boundaries: boundary objects in new product development this is not a boundary object: reflections on the origin of a concept the social life of health information the decision tree: taking control of your health in the new era of personalized medicine publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the datasets generated during and/or analysed during the current study are not publicly available due to the originality of the survey questions, but are available from the corresponding author on reasonable request. the study was approved by our institution's research authority. the following steps to ensure an ethical collection of data were taken: . all data collection was anonymized . participants were not asked to disclose any personal information pertaining to their health. rather they were asked to respond on hypothetical scenarios, as explained in the paper's method section. . the first page of the questionnaire included an instruction page, stating that participation in the survey is free willed. all participants were made to understand that they are free not to answer any question they do not wish to answer. all participants were made to understand that, at any point in the survey, they can stop participating all together, with no consequences. . we made it clear that proceeding to answering the questions, means consenting to participate in the study. the researchers made available their personal details for any questions. our publication does not contain any individual person's data in any form. the study was not funded by any funding organizations. to the best of our knowledge, there are no competing interests.author details dror (imri) aloni center for health informatics, tel aviv, israel. department of industrial engineering and management, ruppin academic center, emek hefer, israel. department of computer and information sciences, ruppin academic center, emek hefer, israel.received: july accepted: october key: cord- -z n ys authors: murray, jillian; cohen, adam l. title: infectious disease surveillance date: - - journal: international encyclopedia of public health doi: . /b - - - - . - sha: doc_id: cord_uid: z n ys world health organization retains copyright in the manuscript and provides elsevier the permission to publish the manuscript as a chapter in this book. infectious disease surveillance is an important epidemiological tool to monitor the health of a population. the goals of infectious disease surveillance are threefold: ( ) to describe the current burden and epidemiology of disease, ( ) to monitor trends, and ( ) to identify outbreaks and new pathogens. first, describing the burden and epidemiology (including seasonality, age distribution, age groups, etc.) of disease is critical for demonstrating the need and advocating for interventions, such as vaccination and mass drug administration. surveillance is also used to detect antimicrobial resistance in certain pathogens (for example, fluoroquinolone resistance in gonorrhea) and the circulating strains of disease, which helps target vaccine interventions (for example, annual influenza vaccine composition). second, infectious disease surveillance is used to monitor disease trends, such as the impact of interventions like vaccination. disease trends do not only mean the number of cases, but also the etiology of cases. for example, after pneumococcal conjugate vaccine introduction, the distribution of serotypes causing disease should be surveyed for serotype replacement, when the incidence of disease caused by serotypes not covered in the vaccine may increase following the decline in disease due to vaccine serotypes from vaccination. information garnered from vaccine effectiveness studies can be coupled with burden and cost information to describe the cost-effectiveness of interventions. surveillance also monitors the control, elimination, and eradication of diseases. disease control refers to reducing the incidence of disease to a desired level (which will vary depending on the disease) and includes diseases such as malaria (dowdle, ) . disease elimination is defined as zero disease in a defined geographic area as a result of control measures. progress toward disease elimination requires control measures to stay in effect. disease eradication is defined as zero disease globally as a result of control measures, which are no longer required. smallpox is the only human disease and rinderpest is the only animal disease that have been eradicated from the world, but efforts are underway to eradicate polio and dracunculiasis. finally, a key aspect of infectious disease surveillance is the cycle of detecting, responding to, and preventing outbreaks. ongoing surveillance for an outbreak-and epidemic-prone disease can facilitate early detection of an outbreak, allowing a more rapid response and therefore mitigation of the outbreak. epidemic meningococcal disease in the meningitis belt in africa requires ongoing surveillance to identify outbreaks in the region. cholera surveillance is maintained globally to detect outbreaks and requires mandatory reporting to the world health organization (who). emerging and reemerging diseases also pose a big risk to public health. these diseases include both unknown pathogens that appear for the first time in a population as well as known pathogens that increase in geographic spread or severity or are reintroduced into the population. the zika outbreak in south america in - demonstrates how rapidly a known pathogen in a naïve population can spread. infectious disease surveillance can have different approaches based on the epidemiology and clinical presentation of the disease and the goals of surveillance. we will discuss some distinctions between infectious disease surveillance methods and give examples below. in passive surveillance systems, medical professionals in the community and at health facilities report cases to the public health agency, which conducts data management and analysis once the data are received. public health staff do not engage in identifying cases but rather assess data completeness and reliability of the reported cases. in contrast, active surveillance requires public health staff to engage actively in the system and take action in order to receive reports of disease cases. this may involve calling or visiting health facilities to encourage follow-up or having staff review medical records to identify cases meeting prescribed case definitions. active surveillance aims to detect every case, and passive surveillance likely misses cases due to the reporting structure. although active surveillance is more comprehensive, it requires significant human and financial resources, so passive surveillance is often implemented. notifiable disease surveillance is an example of passive surveillance. notifiable diseases are classified as such because they are of public health importance: they can be a severe risk to human health, outbreak prone, considered to be an emerging or reemerging disease, or have a timely intervention available for control of the disease. countries mandate which diseases are notifiable, many of which are infectious diseases. globally, the who, as described in the international health regulations, defines what is notifiable by every country to who, such as mers-cov (middle east respiratory syndrome coronavirus) and ebola. nationally notifiable diseases depend on the country. in the united states, the centers for disease control and prevention (cdc) and the council of state and territorial epidemiologists compile a list of diseases that have mandated reporting to the cdc. these include foodborne and sexually transmitted infections, other infectious diseases such as dengue, malaria, and hiv, and noncommunicable diseases such as cancer. the list is updated every year. on january , the list was amended to include zika virus disease after an outbreak in south america resulted in cases being imported into the united states. although not commonly used for surveillance purposes, administrative data or vital statistics are another example of routinely gathered data that can be used as passive surveillance. the international classification of diseases (icd- ) is used globally for the standard naming of diseases in hospitalized patients. administrative data such as hospital billing data using icd codes can be used for syndromic surveillance, such as for pneumonia, if it is available for ongoing monitoring of disease. these data may provide information on the clinical characteristics of patients across different regions and hospitals. active surveillance can have many approaches, including country-wide (e.g., for polio, measles, and rubella) or restricted to sentinel sites that capture cases within a demined catchment population. for example, as of , the whocoordinated global invasive bacterial vaccine-preventable disease (ibvpd) sentinel site surveillance network is a system of more than hospitals in more than countries that conducts active surveillance for meningitis, pneumonia, and sepsis ( figure ). within this network, staff are engaged to work specifically on finding all cases meeting the case definition at the sites. cases are enrolled into surveillance after they have been admitted to the medical facility. a case report form, filled out by the dedicated staff member, details their clinical symptoms. laboratory testing is done at the hospital for initial diagnosis or at a national or regional reference laboratory to monitor for trends in culture positivity and serotype/serogroup incidence. these data are reported to the ministry of health and who. data are analyzed to look at trends of disease, including pre-and postintroduction of vaccine. other diseases that have globally coordinated sentinel surveillance networks include rotavirus, influenza, and congenital rubella syndrome. surveillance for some diseases can be a mixture of passive and active surveillance wherein passive surveillance is complemented by active surveillance to investigate outbreak signals detected through passive surveillance. for example, surveillance for ebola virus disease is ongoing throughout the year as it is a notifiable disease for many countries and globally. during an outbreak, active case finding in the community is enacted to find symptomatic patients as well as contact tracing to find those at risk for developing the disease. choosing where to conduct surveillance is based on a number of considerations: how severe is the disease and how does it present? how important is it to find every single case? how outbreak prone is the disease? cases of infectious disease can be identified at medical facilities (hospitals and outpatient clinics) or in the community. the location of individuals enrolled into surveillance can vary based on clinical presentation of disease and access to health care. more severe cases of disease can often be identified at hospitals. hospitalized cases are those that are severe enough to be admitted to the hospital for treatment and have the resources to seek care. hospitalized cases can be enrolled prospectively or retrospectively when a case report form is filled out based on their medical chart. identifying cases in hospitals can be easier than identifying cases in the community, but the cases may only represent a small proportion of cases and miss cases that do not seek health care. an example of hospital-based surveillance is severe acute respiratory illness (sari) surveillance for influenza. for diseases like ebola, where fear in the community might prevent cases from going to seek health care, hospital surveillance would be insufficient alone. individuals with milder cases of disease may also seek medical care, such as at outpatient clinics, so surveillance may be conducted at medical facilities outside of hospitals, such as with influenza-like illness (ili) surveillance. some cases of disease are so mild or the patient's situation is such that they will not be able to seek care at medical facilities. in that case, community-based surveillance can monitor disease outside of health facilities, such as at schools, homes, traditional medicine practitioners, and other community facilities. this type of surveillance aims to capture cases beyond those that are admitted to a health facility, therefore enrolling a wide range of disease severity and access to medical care. community-based surveillance is useful for surveying diseases targeted for eradication because all cases must be traced and is not limited to those severe enough to be admitted to a hospital or those that have access to a health-care facility. acute flaccid paralysis (afp) surveillance is an active surveillance network that aims to identify every case of polio, which is currently targeted for eradication. suspect cases are sought in the community and at health facilities to identify any unreported cases. this type of surveillance was also a method used in the ebola virus disease epidemic of - . community members and volunteers would report individuals with symptoms meeting the case definition for ebola, who would then be visited by health personnel for testing. community-based surveillance was supplemented by contact tracing, where individuals who had been in contact with confirmed ebola patients were sought out in the community and monitored for symptoms. a sentinel surveillance site is a single or small number of health facilities that are responsible for collecting data on cases enrolled with the case definition under surveillance including global networks surveying for diarrhea or pneumonia. most sentinel sites do not have a predefined catchment population (or denominator to calculate incidence), and therefore data at these sites are simply numbers of cases (numerators). sentinel site surveillance provides useful epidemiological information on proportions caused by different pathogens, age distribution, and risk factors and could also be used for monitoring trends of hospitalized cases within a health facility if health-care patterns and population have been stable. furthermore, these data may be used in case-control studies to assess effectiveness of a vaccine or other preventive measures. surveillance focused on one or a small number of surveillance sites often allows for gathering more data of higher quality. in contrast, with population-based surveillance, every appropriate health facility reports on the predefined diseases with the goal of identifying all cases in a specific geographic area. population-based surveillance can either represent the whole country (national) or a defined subnational population area. since the population is defined, these surveillance sites can produce rates of disease (for example, incidence and mortality rates), which allows for comparison of rates of disease between other population-based surveillance sites. population-based surveillance is more costly than sentinel site surveillance, but produces more generalizable data on incidence of disease. aggregate surveillance data can exist in a variety of forms, but the main feature is that it lacks detailed information on specific cases. aggregate data typically include the number of cases (for example, number of suspect and confirmed neonatal tetanus cases, or by age group) for a specific region and time period. this information can monitor the number of cases but lacks the individual-level data required for specific analyses. an example of this is the integrated disease surveillance and response (idsr) system which asks clinicians to report the number of cases of specific diseases. case-based surveillance refers to surveillance systems that collect information about each case at the individual level. this type of surveillance system has a case investigation form where information can be gathered from the patient or their family members, their medical records, and their laboratory records. at a minimum, more detailed information on person (who is infected), place (where they live, where they might have been infected), and time (when they became ill) is collected. a line list from this investigation form is created and reported up their normal reporting channels. in some scenarios, a case-based surveillance system might transition to aggregate as the number of cases becomes large as it overwhelms the system, like what happened during the h n outbreak. in contrast, an aggregate surveillance system might become case-based temporarily in an outbreak to understand more of the epidemiology of the disease. certain diseases, such as polio and measles, are recommended to be case-based. measles surveillance has seen a movement away from aggregate and toward case-based surveillance (who, ) . initially, when the united nations (un) development goals were established in , measles was endemic in many countries, and mortality reduction was the primary goal. given this, aggregate data were the most feasible approach and were conducted in most countries. by , all six who regions have measles elimination goals. as measles has moved away from control and toward elimination, case-based surveillance is needed to ensure every case is reported and investigated. when disease was endemic, case-based surveillance would quickly be overwhelmed given the time and resources, but as countries have fewer and fewer cases, it is relatively easier to conduct an investigation on every single case. who recommends the type of data to be collected in an investigation. one key advantage of case-based surveillance is that it allows one to analyze which age cohorts are being infected and their individual vaccination status to help to target vaccination efforts and close existing immunity gaps. surveillance networks identify and enroll cases that meet a specific case definition. case definitions have three essential components: person, place, and time. case definitions vary in sensitivity and specificity. sensitive case definitions are more inclusive, are less likely to miss cases, but will include patients that do not have the disease. specific case definitions have stricter criteria and exclude more patients that do not have the disease but can also miss patients with milder or atypical disease presentations. both sensitive and specific case definitions can be used in infectious disease surveillance depending on the goals of surveillance. for example, sensitive case definitions may be preferred if it is important not to miss cases. in general, case definitions should be as sensitive and specific as possible. however, since a highly sensitive and specific case definition is not always possible, it is important that the case definition is at least applied systematically and consistently over the surveillance period. syndromic surveillance involves monitoring cases that meet a clinical case definition for the disease under surveillance, typically without laboratory confirmation (henning, ) . this allows for rapid identification of a cluster of cases that might warrant further investigation. an example of syndromic surveillance includes acute fever/rash surveillance in many countries, which is used to monitor measles and rubella. the fever and rash could be due to a multitude of causes, and if there is an increase in the number of fever/rash cases reported, this could indicate an outbreak. as field investigations are ongoing, laboratory testing can be performed on some or all of the cases identified by syndromic surveillance to determine the etiology. in the acute fever/rash surveillance system, laboratory specimens might be collected to undergo testing for measles and rubella. a wellestablished global who-coordinated measles laboratory network provides support to monitoring measles cases and provide genotype information globally. syndromic surveillance case definitions can be used in emergency or outbreak situations as an alert system to identify suspect cases that meet a broad case definition to then be further investigated. during the ebola outbreak in - , airport security was increased to identify people with a fever and a history of travel to an ebola-affected country in order to stop the disease from traveling between countries. in contrast, some surveillance case definitions are based on confirmed cases in a laboratory where the etiologic agent can be identified through a variety of laboratory tests (e.g., serology testing, bacterial culture, or molecular diagnostics) or at the bedside with well-validated commercial rapid diagnostic tests (e.g., malaria and streptococcus pneumoniae). as an example, virologic influenza surveillance networks use laboratoryconfirmed influenza to determine the circulating strains to provide information for vaccine composition. a critical objective of laboratory-based surveillance is to monitor for emerging drug resistance in pathogens or shifts in serotype distribution. cases meeting a suspect case definition (a sensitive case definition) may undergo laboratory testing leading to a more specific case definition. for example, the case definition for suspect meningitis as part of the who invasive bacterial vaccine-preventable disease network is very sensitive: a hospitalized patient at a surveillance hospital with sudden onset of fever and at least one meningeal sign during the surveillance period. after being enrolled into surveillance, additional clinical and laboratory information can reclassify a patient as having probable bacterial meningitis (namely having abnormal white cell count, protein or glucose levels in cerebrospinal fluid). this definition has a greater specificity but lower sensitivity. the most specific meningitis definition is confirmed meningitis by polymerase chain reaction assay or other laboratory test. this definition may lose some sensitivity because confirmatory tests can have false negatives, especially in areas with high antibiotic usage. zoonotic diseases cause disease in humans and can be challenging to control since both animals and humans can be hosts. many zoonotic diseases of public health importance are covered in other articles of this encyclopedia, including west nile virus, avian influenza, ebola (and other hemorrhagic fevers), lyme disease, sars, nipah virus, and rabies. historically, zoonotic and human disease surveillance existed separately, but there is a push to harmonize these systems to improve surveillance for diseases affecting both populations. illness in one species might be a harbinger of illness in humans, and an integrated comprehensive surveillance system can help identify potential disease transmission that might be ongoing. for example, surveillance for borrelia burgdorferi, the causative agent of lyme disease, in the tick population can help public health authorities determine proper interventions to decrease the transmission from ticks to humans. one health emphasizes the link of human health to the surrounding environment and animals. one of the mission statements of one health is to improve the lives of all species by harmonizing both animal and human disease surveillance and control efforts. international organizations participating in one health include who, the un food and agricultural organization, and the world organization for animal health. serosurveillance involves the use of blood specimens to determine the burden of disease or immunity gaps in a population. serosurveillance is frequently done as a periodic survey for multiple diseases of interest simultaneously. however, serosurveillance cannot provide information in a timely manner; thus an outbreak might have occurred that is discovered by serosurveillance, but it might be potentially too late for an intervention to decrease disease transmission. serosurveillance is sometimes the only type of surveillance conducted for an infectious disease. for example, hepatitis b is frequently asymptomatic in children, making evaluating the impact of vaccination efforts extremely challenging (who, ) . the standard has become to perform serosurveillance among cohorts of vaccinated children to identify the burden of disease and determine the impact of vaccination efforts. in some countries, national health surveys, such as the national health and nutrition examination survey (nhanes) and malaria indicator surveys, are conducted periodically and include a serologic component, allowing one to monitor trends in diseases and immunity over time. for example, nhanes includes data on hepatitis b, c, and d antibodies. adverse events following immunization (aefi) surveillance is a critical component of ensuring vaccine safety in the populations where the vaccines are being used. surveillance often begins at the health facility level, where health workers are trained to recognize adverse events from immunizations, and is reported to national regulatory agencies and who. this surveillance is critical for investigating problems that could occur with bad lots of vaccines and mishandling of vaccines in the cold chain (improper storage) which can contribute to the public perception of the vaccine program. technology is increasing the availability of data on health that can be used for infectious disease surveillance, including sources that go beyond that of traditional passive or active surveillance systems. new sources of data include mobile data, electronic health records, and social media. these aggregate sources and the speed at which they can be compiled are referred to as 'big data' (wyber et al., ) . these sources of data can provide more real-time information to help mitigate outbreaks or improve the health of a population. in , google started a venture called 'google flu' which was an algorithm tracking global search habits (such as search engine queries for 'influenza') with the hope that it could act as a real-time syndromic surveillance system. it was one of the first 'nowcasting' surveillance technologies and was able to predict influenza disease with some accuracy, close to the us cdc influenza reports based on laboratory-confirmed influenza surveillance. however, after a couple of years, it was found to overpredict the number of influenza cases given the generic case definition used. the system is no longer active, but is used to help groups develop newer public health analytics. the use of mobile technology to improve systems is an important area for public health (also referred to as mhealth) and has a growing use for surveillance. mobile data can monitor the movement of people during an outbreak, and this information can allow health officials to better predict where a given disease will spread. the un pulse project supports infectious disease mapping in kampala, uganda, using m-health (un global pulse, ) . in , there was a typhoid outbreak in uganda. the pulse lab in kampala provided mobile data to complement data which the ministry of health collected on cases. these data sources combined allowed better visualization of the outbreak and where clusters of infections were happening and therefore permitted improved mobilization of resources to respond to the outbreak. flowminder is another organization developing the use of mobile technology in outbreak situations. it currently has projects supporting monitoring the spatial patterns of individuals during outbreaks using data from mobile phones. during a cholera outbreak in haiti in , researchers from flowminder mapped the movement of people using anonymous data from mobile usage from the affected areas (bengtsson et al., ) . following the outbreak, the data were analyzed, and it was shown that this was an effective way of mapping the spread of the outbreak. many partnerships between academic, programmatic, and global organizations exist to facilitate ongoing infectious disease surveillance and promote global health security. partnerships can take different forms and often include providing technical and operational support and resources to facilitate ongoing surveillance. some examples are as follows. in , the idsr strategy was first drafted by the who regional office for africa in order to harmonize existing surveillance networks (including afp and neonatal tetanus) in the african region (who, ) . the strategy aims to integrate surveillance being done at the community, health facility, district, and national level to improve the data collected and to conserve resources. idsr includes standard case definitions and protocols and involves collecting only data necessary for disease control, often aggregated data. this helps to decrease the work burden at all levels on health staff, is more efficient, and costs less than nonintegrated surveillance. however, the challenge of integrated disease surveillance is that sometimes more information is needed than is readily available to target intervention activities. the global outbreak and response network (goarn) is a who-coordinated network comprised of over partners worldwide, including government, technical, and academic institutions involved in epidemic surveillance. the purpose of goarn is to coordinate a rapid response to international disease emergencies through deployment of resources to the affected countries. goarn coordinates a multidisciplinary team comprising clinicians, epidemiologists, social mobilization, and communications experts. the increase in international travel is an important risk factor in the spread of infectious diseases. travelers can contract many infectious diseases, from common travelers' diarrhea to more serious conditions such as ebola. this can pose a serious public health risk if conditions are right for an outbreak or when novel pathogens are introduced into a naïve (not vaccinated or without protective antibodies) community. geosentinel is a global network of clinics assessing travelers' and migrants' health for illnesses acquired while abroad (leder et al., ) . this network of clinics confirms and registers cases of infectious diseases acquired while traveling. this surveillance information is critical for tracking the movement of diseases and informing guidelines for travel medicine. surveillance is an action-oriented public health tool. time lags in surveillance can affect outcomes if there is not a rapid response with interventions. surveillance information can be used at the global, regional, national, local, and individual levels. new technologies are being developed to assist with more real-time data dissemination. surveillance bulletins and reports are a frequently used method for disseminating surveillance information. many surveillance networks use them to send information to stakeholders and partners involved with the surveillance. these can be frequent (weekly or monthly reports) or more infrequent such as annual or biannual surveillance bulletins. these normally include case counts for the disease under surveillance or detection of new outbreaks. the scientific literature (peer-and non-peer-reviewed publications) and scientific conferences are also important venues for disseminating surveillance data. the audience for publications can be much wider than bulletins since they are accessible by a wide range of individuals. there can be a long lag-time between data generation and publication. these modes of communication are critical for improving the wealth of available knowledge and advancing research, but are not timely enough to mobilize a response to an outbreak. the morbidity and mortality weekly report (mmwr) from cdc and the weekly epidemiological record (wer) from who are two examples of periodic, non-peer-reviewed dissemination tools. the mmwr publishes an annual list of notifiable diseases using weekly data on the cdc surveillance systems. the mmwr publishes weekly reports for outbreaks and case reports for diseases under the international health regulations. with the advance of social media and the internet, there have been innovative strategies for more quickly disseminating surveillance information for rapid public health intervention. for example, the program for monitoring emerging diseases (promed) is a popular tool run by the international society for infectious diseases. it consolidates and verifies reports from media, observers, and news and disseminates via email and their website. they have a large audience since their information is free and easily available on the internet. they act as an important early warning of outbreaks to facilitate public health preparedness. online platforms are creating innovative ways of displaying the surveillance data that are collected. an online platform called healthmap run by boston children's hospital is one example (figure ) . reports of disease cases come from a series of vetted online sources (including promed, who, and online news outlets) and are mapped on an interactive interface allowing users to view the geographic distribution of multiple diseases. physicians and individuals can use healthmap to identify diseases occurring close to them or their travel destination. other tools include the health alert network (han) at cdc, which is used for quickly disseminating confirmed disease reports and information to medical and public health professionals at a national level. han disseminates four types of information: ( ) health alerts (where an action required); ( ) health advisories (information on health events where no action required), ( ) health updates (information on given events); and ( ) general public health information. in february , han released an official cdc health advisory on preventing sexual transmission of zika virus after a confirmed sexually transmitted case in texas. event-based surveillance entails monitoring cases and outbreaks of disease through formal and informal news and online reporting platforms. traditional surveillance can miss many outbreaks or delay the opportunity to intervene. eventbased surveillance includes reports from the community, health facilities, universities as well as media and online sources in order to develop alerts of health situations that are developing. the data and reporting methods are much less structured than other surveillance, but allow for quick detection of events that need to be investigated. surveillance is in and of itself a critical tool for public health. using an existing surveillance network as a platform for surveillance of additional diseases allows streamlining resources and can be a cost-effective measure to improve public health. for example, influenza surveillance is being leveraged to conduct surveillance for other respiratory viral diseases, such as respiratory syncytial virus. additionally, the laboratory, clinical, and epidemiological capacity built to run a surveillance network can be utilized for other public health studies. surveillance sites can be used as platforms for research and special studies. since infectious disease surveillance sites often conduct surveillance for vaccine-preventable diseases, studies on vaccine effectiveness and vaccine impact can be built on the platform of surveillance. vaccine impact studies can use surveillance to demonstrate reduction of disease after introducing an intervention such as a vaccine. these impact studies require baseline data before the vaccine was introduced in order to compare the postvaccine era to the prevaccine introduction disease incidence. special studies that gather additional information may complement surveillance disease trends. vaccine effectiveness studies evaluate the ability of a vaccine to control the disease in a real-world setting, which differs from vaccine efficacy studies where the vaccine impact is estimated in a controlled clinical situation. a good example of this is rotavirus diarrheal sentinel site surveillance, which has been used both to show the decline in rotavirus disease among age groups vaccinated as part of routine immunization and has also been used as a platform to conduct vaccine effectiveness studies. estimating the burden of disease at the country or global level with epidemiological models can be a critical part of using surveillance data and advocacy for disease interventions. in many countries, surveillance data alone may not be sufficient to provide informative data for a specific disease for a number of reasons: surveillance data may not be available, there might not be laboratory confirmation, or the data necessary to answer a certain question may not have been collected. in these situations, models using local and nonlocal data can be very useful. in addition to data from one region being extrapolated to inform on the disease within that region, data from similar regions can also be used to fill in gaps where surveillance is missing. there are many global burden estimation projects updated regularly to give global prevalence and mortality estimates by different government, research, and academic groups for a number of diseases (for example, influenza, s. pneumoniae, and rotavirus). burden estimation modeling can also be done on the national level using surveillance data collected locally. surveillance data have been used in a model to extrapolate the burden of influenza-associated hospitalizations in south africa, guatemala, and kenya using local surveillance data from the country (murray et al., ) . using mobile phone data to predict spatial spread of cholera the principles of disease elimination and eradication overview of syndromic surveillance: what is syndromic surveillance? geosentinel surveillance of illness in returned travelers figure healthmap displaying reported measles cases for the past month determining the provincial and national burden of influenza-associated severe acute respiratory illness in south africa using a rapid assessment methodology data visualisation and interactive mapping to support response to disease outbreak who-recommended standards for surveillance of selected vaccine-preventable diseases [online]. who document production services technical guidelines for integrated disease surveillance and response in the african region documenting the impact of hepatitis b immunization: best practices for conducting a serosurvey big data in global health: improving health in low-and middle-income countries united nations global pulse the views expressed in this article are those of the authors and do not necessarily reflect the views of who.see also: childhood infectious diseases: overview; ebola and other viral hemorrhagic fevers; geographic information systems (gis) in public health; health-care delivery systems; influenza; measles; poliomyelitis; surveillance of disease: overview. key: cord- - fghudac authors: qoronfleh, m. walid title: health is a political choice: why conduct healthcare research? value, importance and outcomes to policy makers date: - - journal: life sci soc policy doi: . /s - - - sha: doc_id: cord_uid: fghudac this paper offers the eastern mediterranean region (emr) viewpoint with qatar as a case for lasting transformation of health systems. the qatar case study illustrates the importance of research in the development of health policy. it provides description of a series of projects that have been undertaken in relevant national areas such as autism, dementia, genomics, palliative care and patient safety. the paper discourse draws attention to investment requirement in health research systems to respond to country national health priorities and to strengthen public health policies for improving health and social outcomes by narrowing the gap between research and politics. in short, the discussion highlights the following: i) health is a human right marching towards universal health care, with research underpinning every advance in health care and quality medical services; ii) evidence-based research is emerging as a critical tool to aid policy- and decision-makers; iii) investment necessity in healthcare research/systems to enable responding to a country’s national health priorities and to strengthen public health policies; and iv) need for multi-sectoral involvement of stakeholders to bridge the gap between research and politics. finally, atypical stakeholders’ engagement and bond to politics is a prerequisite to achieve healthcare objectives and policy success so as to reap the benefits of public health results. historically between the th - th century, the eastern mediterranean region (emr, as defined by the who) had a remarkable influence on health care research and systems for a string of many firsts in diagnosis, treatment and patient management including many scientific discoveries (majeed ; pallejà de bustinza ) . today, in the emr non-communicable diseases account for % of disease burden having the highest traits of risk factors as well such as obesity, smoking and sedentary lifestyle, thusly, increasing mortality amongst the population. indeed, the world health organization (who) statistics speaks vividly of this challenge (fouad et al. ) . definitely, there are major health and development challenges facing the emr. amongst these chief challenges are resource constraints, regional conflicts, and inadequate health systems research that compound and exacerbate many issues confronting emr, all of which make for uncertain future for the region. it is about time to re-envisage health systems. it is critical to breakdown silos and boundaries, re-orientate health systems to address public health and the broader ecosystem influencing health. this treatise presents an emr perspective with qatar as an example for long-term transformation of health systems. the discourse highlights investment in health research systems (hrs), how hrs respond to country healthcare priorities and discussing the broader influence on emr. equally important, how essential and imperative is research/gained knowledge in the development of health policy. health research is very important and has high value to both individuals as well as society. overall, healthcare research can contribute to information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and health care costs and use. different healthcare research types provide complementary insights. for instance, clinical trials can provide critical evidence about the efficacy and adverse effects of therapeutic treatment; also, crucial post-market surveillance data for comparing and improving the use of drugs, vaccines, medical devices, and diagnostics. therefore, clinical experience at a population level is imperative for identifying relatively rare adverse effects and for determining the effectiveness in different subpopulation groups (stratification) leading to precision medicine and individualized therapy. ultimately, this allows the actual development of clinical guidelines for best practices and to ensure high-quality patient care. clinical healthcare research have led to significant discoveries, the development of novel therapies, and a remarkable improvement in health care and public health. economists have found that medical research can have an enormous impact on human health, wellbeing and longevity, and that the resulting increased productivity of the population contributes greatly to the national economy (hatfield et al. ; murphy and topel ) besides the obvious individual benefits of improved health. if the research enterprise is impeded, or if it is less robust, vital societal interests are affected. clinical research and clinical trials registry are yet to be fully established in most of the emr countries or have formulated laws governing the conduct of clinical trials. moreover, system maturity vary between emr countries. the middle east north africa (mena) region is predicted to be one of the leading regions for clinical research outsourcing due to the availability of essential infrastructure for the conduct of clinical trials, access to required patients and financial benefits. public healthcare research with a particular focus on health services research is another approach to provide information and practical knowledge to improve health outcomes and return on investment. for example, the development of herceptin, a breast cancer treatment, is a prime illustration of the benefits of healthcare research using biological specimens and patients' medical records (slamon et al. ) . other examples of findings from healthcare research have changed the practice of medicine as well. a case in point, research underlying estimated patient's death from medical errors in hospitals, which has provided valuable proof for reducing these medical errors by implementing health information technology like e-prescribing (bates et al. ) . furthermore, medical records research has demonstrated that preventive screening services (e.g., mammography) substantially reduce mortality and morbidity at very reasonable cost (mandelblatt et al. ) . similar kinds of investigation has also established a correlation between nursing shortage and patient health outcomes by documenting that patients in hospitals with fewer registered nurses stay in hospital longer, thus, are more likely to suffer complications the likes of urinary tract infections, upper gastrointestinal bleeding and nosocomial infections (needleman et al. ) resulting in increased hospitalization cost. these findings have all informed and influenced policy decisions at the national level with effective change to medical practice, cost containment and improved outcomes. as the use of electronic medical records increases, the pace of this form of research is accelerating, and the opportunities to generate new knowledge about what works in health care are expanding (coalition for health services research (chsr) ). poor health information system has been identified as a major challenge in the emr healthcare system. even though, emr countries have embraced healthcare technology advances in the last decade along with tremendous investment in healthcare it products and services in order to drive higher adoption of electronic and digital healthcare systems. however, computer and english literacy remain an issue. the available evidence indicate that the region still lags behind and that there were many factors that hindered the widespread adoption such as cost, procurement and maintenance. health is a human right, with research underpinning every advance in health care. the goal is to attain universal healthcare coverage. undeniably, better research, i.e., evidence-based yields better health. evidence-based research is emerging as a critical tool to policy makers. increasingly, quality research that is backed up by caliber data/information and superior analytics is being utilized by policy and decision makers to formulate, enact and improve government policies thus influencing a country's health status and population health. a case in point, europe leads in many areas of research and has developed powerful models of cross-border, cross-sectoral research cooperation. the scientific panel for health (sph) is a science-led stakeholder platform, which elaborates scientific input concerning this societal challenge. it assists the eu commission in the preparation of legislative proposals and policy initiatives. this expert led group has proposed the creation of european council for health research to provide a comprehensive policy for health research in europe and facilitate crossborder collaboration (the lancet ). it is anticipated that these actions would lead to improved overall health outcomes and health economics, in other words better outcomes related to efficiency, effectiveness, value and behavior in the production and consumption of health and healthcare. since the inception of the first global symposium on health systems research and the era of sustainable development goals (sdg) the goal of 'leaving no one behind' is falling behind. the intertwined complexities and issues facing emr require an evolution from primary focus on health to a broader focus on sdgs' and multi-sectoral involvement. therefore, strengthening science, research, policies and societal engagement for the emr countries is critical to ensure dialogue continuity and experience healthcare improvements at all levels. continued investment in hrs not only is essential but also is an enabler to equip countries to deliver on promises and resolve increasingly complex and interconnected health and development challenges of the twenty-first century. devoting time and resources to integrated knowledge translation and engaging atypical stakeholders is a fundamental paradigm shift in the way we think about health systems. this demands being self-critical of the systems, to engaging with the social determinants of health to appealing to health systems influencers such as political and financial intuitions. emr mandatory achievement pillars are strengthening public health policy and improving health outcomes by narrowing the gap between research and politics. finally, wish, its research team and the qatari health research community at large are working to communicate and educate the public about why healthcare research is important and how healthcare research is done. equally important, healthcare researchers must convey the value of health care improvements derived from public health research, quality of medical records, availability of biological samples and to stress the negative impact of incomplete datasets/analysis on research findings vis-à-vis public health. in this vein, the qatar ministry of public health (moph) organized its first biennial qatar public health conference (qphc) from to november at the ritz carlton hotel | doha, qatar. the moph public health department has organized qphc to convene every years to discuss distinct public health themes with insights from national, regional and international experts. in preparation for the fifa world cup , which will be held in qatar, qatar health a first of its kind healthcare conference aimed at improving healthcare professionals' understanding of mass gathering events and informing policies. the conference -a collaborative effort between hamad medical corporation (hmc) and moph -took place from to january at the sheraton grand doha resort and convention hotel | doha, qatar. the covid- pandemic incidence is a stark reminder of the risk threat posed by communicable disease outbreaks including spread at major sporting events. the world innovation summit for health (wish) and the research team are committed to positively influencing public health research and policies in qatar. these areas include autism, mental health, dementia, patient safety, non-communicable diseases (cancer, diabetes & obesity), precision medicine and bioethics. wish endeavors to address qatar's national healthcare priorities. the environmental context is described below. additionally, it elaborates on the importance of multi-sectoral engagement to galvanize the community to work around silos and boundaries demonstrating appreciation to the influence and proper understanding of the qatari culture and business norms. similar to other countries in the region, qatar has witnessed a rapid change in many aspects of life over the past four decades. primarily because of rapid urbanization and socioeconomic development following the region's "oil boom" that took place between and , qatar's population today enjoys a very different standard and way of life compared to earlier generations. qatar has recently emerged as one of the wealthiest countries in the world when measured in terms of gross domestic product (gdp) per capita (the heritage foundation ). among other indicators, great progress is being observed when it comes to the country's health data, which reveals an increasing life expectancy and a significant drop in infant mortality. qatar has achieved overall better health outcomes over the past several decades due to making significant investments in the healthcare infrastructure. the state boasts the highest life expectancy rate in the world health organization's eastern mediterranean region (emro), and globally ranks in the top th percentile for healthcare access and quality. qatar's healthcare expenditure and investment is also among the highest in the middle east, with qr . billion (usd $ . billion) invested in . these achievements have led some organizations to rank qatar fifth ( th) in the world for healthcare (legatum institute ). certainly, qatar has the financial prowess with a budding health care system. the healthcare system, healthcare infrastructure and public health policies continue to be on a developing trajectory towards an ambitious personalized healthcare goal. in , the moph-qatar launched its second national health strategy (nhs, - aka nhs . ), which signified an important step in the state's health system development. the second national health strategy was developed taking into account the united nations (un) agenda for development, the who's recommendations and objectives, and the regional context. the nhs . has established three main objectives: better health, better care, and better value. priority areas include the development of an integrated model of high-quality care and service delivery for the state of qatar; enhanced health promotion and disease prevention; enhanced health protection; health integrated across the country in all policies; and establishing effective systems of health governance and leadership. the legendary management consultant and writer peter drucker is famously quoted "culture eats strategy for breakfast". these developments and achievements would not have been possible without convening key opinion and thought leaders, developing a global health viewpoint, and committing to encourage on evidence-based research. a multisectoral approach that is culturally sensitive is powerful and empowering. it is a surer route to success. the qatar case study series illustrates the significance of research in the development of health policy. research is at the core of everything wish does. wish is continuing its contribution to improve qatar's healthcare system. research undertaken by wish has made a significant influence to national policies in qatar. few examples are highlighted below that address qatar's national priorities and are in alignment with moph national health strategies. the specific projects case studies show the importance of application of knowledge coming from research. further, they elucidate and emphasize the link between health, society and policy to improve both health and social outcomes. the diverse stakeholders' participation ensures alignment, endorsement and drives action. this is exemplified in the underneath narrative. the social and economic burden of dementia is clear and enormous even today. the staggering increase in the prevalence of autism spectrum disorder ( have provided the foundation of evidence based knowledge to frame the national dementia strategy and the national autism strategy, which were launched in and , respectively. in addition, the policy report on dementia has provided a vehicle for the country's involvement in the who global dementia observatory that continues to this day. wish has also implemented the report findings through pioneering community outreach and awareness programs such as providing more social and recreational services to qatar's autism community . estimates show that in high-income countries as many as in patients is harmed while receiving hospital care. patient death occurring due to a preventable medical accident, while receiving health care, is estimated to be in . approximately two-thirds of all adverse events occur in low and middle-income countries (sources who august ). one of the key policy recommendations from the wish report on patient safety [transforming patient safety: a sector-wide approach, ] was focused around the need and urgency of including patient safety in the curriculum of medical/clinical majors. following that, wish collaborated with medstar health, usa and moph to bring the academy for emerging leaders in patient safety to qatar on an annual basis and to conduct a capacity building program, an inter-professional intensive training for both faculty members and students on reducing medical errors in the hospital setting. since its inception in , over participants from all health science colleges around qatar have graduated from the program. wish patient safety framework and qatari experience were also on display at two international conferences. at the th international patient safety conference - september , novotel hicc, hyderabad, india and at the th international conference on patient safety november - december, organized by riphah institute of healthcare improvement & safety and hosted by rawalpindi medical university (rmu), rawalpindi, pakistan. hence, stressing the worth and benefit of this work beyond the local public to influencing the global healthcare community especially for recognized countries with resource constraints. health systems around the world are facing rising health expenditures due to aging populations with complex conditions, new medical technologies, and challenges in providing universal access to care. consequently, policymakers are developing more person-centered care models, and "value-based" payment reforms to support and sustain them. many health systems are implementing accountable caredefined as a group of providers who are held jointly accountable for achieving a set of outcomes for a defined population over a period of time and for an agreed costto adopt the necessary organizational competencies and health policies needed to implement innovations in care that support better population health while avoiding unnecessary costs. in , wish led the efforts in establishing a multidisciplinary task force to implement an integrated care model between primary health care corporation (phcc) and hmc, which was published in its forum report [implementing accountable care to achieve better health at a lower cost, ]. the pilot phase of the project resulted in the smart clinic project, a national diabetes screening and prevention program. the pilot demonstrated how a health system could begin implementing accountable care by reorganizing care delivery before addressing payment reform. this model has now been expanded and adapted by phcc and hmc to tackle screening and prevention of other chronic diseases evolving into the "the better together program" besides being incorporated into the nhs . strategy. qatar's national health strategy, - , highlights the need for creating quality, care delivery infrastructureso-called "high-value health systems"to enable such improvements in patient access, affordability, and outcomes. the latest policy and outcome developments facilitated by wish were discussed in a roundtable on the th of november at qncc in doha with duke university center for health policy and phcc leadership. given the foreseeable scientific leap in genomics in the gulf region, the need for a solid knowledge base pairing scientific research with cutting-edge research in islamic ethics is more urgent than ever. managing the promising, pioneering genomics outcome coupled with the potential ethical challenges is a conundrum, one that requires acknowledging and understanding the religio-cultural fabric of this region and the wider muslim world to which it belongs (al-dewik and qoronfleh ). religion and socio-cultural ethical conduct not only influence research but also shapes political/policy perspectives. in , the qatar national research ethics committee published the country's very first "genomic policy" that aims at assisting investigators in the design and conduct of genomic research, oversees genomic research activity and addresses the different associated risks. this was based on the policy recommendations that stemmed from the report that was published in by wish entitled genomics in the gulf region and islamic ethics, . palliative care (pc) is a relatively new medical specialization that embodies a number of universally shared values. its principal aims are to relieve pain and other distressing symptoms, improve quality of life for individuals living with serious illness, and provide patients with good end-of-life care. pc physicians face various ethical dilemmas. experts predict a rise in the demand for pc. there are various reasons for this, such as the increase of geriatric populations and prevalence of chronic and life-limiting diseases, which affect a population regardless of age. to provide culturally sensitive pc, patients' (religious) beliefs and moral worlds must be integral parts of the care package. pc is an integral part of healthcare, and many countries in the arab/islamic world are increasingly offering this care. this is an area of particular sensitivity and interest within the region including the state of qatar, and represents a growing need for both clinicians and family members to have access to culturally acceptable guidance, which would alleviate suffering and facilitate compassion. through the wish policy report [palliative care and islamic ethics: exploring key issues and best practice, ], the proposed guidelines are under consideration, and should stimulate and galvanize efforts at the national as well as the regional levels. wish has recently launched an awareness campaign around palliative care practice both regionally and nationally. wish and the pontifical academy for life (vatican city) jointly organized a two-day symposium on religion and medical ethics - december . this special symposium examined the role that religion plays in providing holistic care in the context of medical ethics. by focusing on the intersection of belief-based and evidence-based approaches to care, speakers and participants had the opportunity to highlight and explore the benefits of interdisciplinary and interfaith approaches to treating the body, mind and soul. the two main topic areas of healthcare were palliative care and the mental health of the elderly. the aim was to harness intellectual input, deliberations, and to produce a special report with a framework and/or action plan with policy recommendation to facilitate national policy composition or guidelines to healthcare facilities that are integral to holistic care including workshops development and training sessions for healthcare workers. a vivid example of robust cross-cultural interaction and interfaith dialogue. effective and high-quality health systems rely on multidisciplinary teams. nurses and midwives play a central role in all health systems. the who has declared that is the "year of the nurse". in , wish published a report on nursing and midwifery [nursing and midwifery the key to the rapid and cost-effective expansion of high quality universal health coverage, ]. this report is about the contribution of both nurses and midwives to universal health coverage (uhc). additionally, in partnership with the moph, wish has been instrumental in the establishment of nursing now qatar. indeed, nursing now qatar was one of the very first to be launched in the mena region and has firmly put qatar at the vanguard of this global campaign. while still in its relative infancy, this program will address significant workforce issues and capacity building including promoting the profession and encouraging retention, both now and in the future, around nursing and midwifery in qatar. wish also welcomed representatives from countries across asia, africa, and the middle east and conducted a two-day symposium for nursing leaders on health workforce data on april at qncc, doha, qatar. the workshop was in consultation with hmc and who. afterwards, wish has partnered with the global nursing now campaign and the international council of nurses (icn) offering a nursing symposium to train young nursing leaders from around the world to amplify their voices and positively influence healthcare policy, and underscore their role in uhc ahead of attending the annual world health assembly in geneva, switzerland. health is a human right, with research underpinning every advance in health care. undoubtedly, better research that is evidence-based yields better health. the emr is facing considerable challenges. a game changer approach is the broad, multi-sectoral involvement of stakeholders to bridge the gap between research and politics. this leads to strengthening public health policy and improving health/social outcomes. evidencebased research is emerging as a critical tool to policy makers. this type of research should be more accessible to policymakers. for instance, the sixth global symposium on health systems research (hsr ) served as a catalytic platform for sharing knowledge and experiences, raising awareness and advocating for change, building capacity, and developing strategic partnerships to address the challenges facing health and development today. wish, its research team, and the qatari health research community at large are working to educate the public about why healthcare research is important and how healthcare research is done. equally important, healthcare researchers must convey the value of health care improvements derived from public health research, ensuring a high quality of medical record keepings, and through the availability of biological samples, and to stress the negative impact of incomplete datasets/analysis on research findings vis-à-vis public health, and use of evidence-based research in policy formulation as well as intervention. wish is addressing qatar's national priorities that are in alignment with moph national health strategies. in sum, lessons learned to implement policy recommendations or enact successfully policies include: i) recognize that health is a human right to achieve universal health care, with research underpinning every advance in health care, ii) execute evidence-based research, it is a critical tool to policy-and decision makers, iii) invest in health research systems to respond to country national health priorities, strengthen public health policies including their outcomes and deliver quality medical services, and iv) involve multi-sectoral stakeholders to bridge the gap between research and politics. finally, it is our firm belief that atypical stakeholders' engagement and bond to politics is fundamental to achieve healthcare objectives and policy success so as to reap the benefits of public health results. genomics and precision medicine: molecular diagnostics innovations shaping the future of healthcare in qatar. advances in public health effect of computerized physician order entry and a team intervention on prevention of serious medication errors framework for health services research policy for scaling up prevention and control of noncommunicable diseases in the who eastern mediterranean region exceptional returns: the economic value of america's investment in medical research the legatum prosperity index: qatar how islam changed medicine: arab physicians and scholars laid the basis for medical practice in europe the cost-effectiveness of screening mammography beyond age : a systematic review for the u.s. preventive services task force the economic value of medical research nurse-staffing levels and the quality of care in hospitals how early islamic science advanced medicine. national geographic history magazine response to the burden and impact of dementia through policy and innovation autism in the gulf states: a regional overview human breast cancer: correlation of relapse and survival with amplification of the her- /neu oncogene index of economic freedom: qatar the lancet the author wants to thank his institution for their continued support.author's contributions mwq conceived, designed and implemented conceptual work, framework, writing and critical editing. author read and approved the final manuscript. availability of data and materials all data generated or analyzed during this study are included in this published article. none. the author declares that there are no conflicts of / or competing interests.ethics approval and consent to participate none applicable. received: may accepted: june publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -c mzcu authors: shukla, nagesh; pradhan, biswajeet; dikshit, abhirup; chakraborty, subrata; alamri, abdullah m. title: a review of models used for investigating barriers to healthcare access in australia date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: c mzcu understanding barriers to healthcare access is a multifaceted challenge, which is often highly diverse depending on location and the prevalent surroundings. the barriers can range from transport accessibility to socio-economic conditions, ethnicity and various patient characteristics. australia has one of the best healthcare systems in the world; however, there are several concerns surrounding its accessibility, primarily due to the vast geographical area it encompasses. this review study is an attempt to understand the various modeling approaches used by researchers to analyze diverse barriers related to specific disease types and the various areal distributions in the country. in terms of barriers, the most affected people are those living in rural and remote parts, and the situation is even worse for indigenous people. these models have mostly focused on the use of statistical models and spatial modeling. the review reveals that most of the focus has been on cancer-related studies and understanding accessibility among the rural and urban population. future work should focus on further categorizing the population based on indigeneity, migration status and the use of advanced computational models. this article should not be considered an exhaustive review of every aspect as each section deserves a separate review of its own. however, it highlights all the key points, covered under several facets which can be used by researchers and policymakers to understand the current limitations and the steps that need to be taken to improve health accessibility. appropriate and timely access to healthcare is of the utmost importance; if not provided, it can lead to several concerns like missed scheduled appointments, delayed medication, and potential fatality. the barriers to accessibility are varied and are dependent on location, affected disease and patient characteristics. australia is a vast country with a very diverse population where settlement is spread thinly over vast areas [ ] . the country also has an aging population which will require healthcare support in the future. therefore, understanding the models used to analyze barriers to healthcare access across various diseases is crucial. in terms of geographic patterns, % of the population live in rural and remote areas; they have lower usage rates due to the distance-decay relationship. the distance-decay association suggests that people who live farther from healthcare facilities have lower rates of usage, after the adjustment of other factors for need, than those who we also analyzed the states where the studies were conducted. the results reveal that % of the studies were conducted on a national level. the studies conducted in specific states are illustrated in figure . the analysis was performed based on the state where the study was conducted irrespective of covering a small part of the state. we also analyzed the states where the studies were conducted. the results reveal that % of the studies were conducted on a national level. the studies conducted in specific states are illustrated in figure . the analysis was performed based on the state where the study was conducted irrespective of covering a small part of the state. we also analyzed the states where the studies were conducted. the results reveal that % of the studies were conducted on a national level. the studies conducted in specific states are illustrated in figure . the analysis was performed based on the state where the study was conducted irrespective of covering a small part of the state. healthcare access was classified into categories in [ ] , which are: (a) availability, (b) accessibility/proximity, (c) affordability, (d) acceptability and (e) accommodation. the first two (availability, accessibility) can be considered spatial whereas the remaining factors are non-spatial [ ] . geographic information systems (gis) is considered a powerful tool to integrate both spatial and non-spatial factors [ ] . however, most studies analyzed hindrance to access in the spatial context irrespective of disease type. the studies focusing on spatial accessibility were analyzed using three different techniques: (i) distance/time to nearby services, (ii) gravity models and (iii) population versus provider services: doctor-population ratio (dpr) or bed-population ratio (bpr) [ , ] . the first approach is a simple technique wherein the distance between population residence and service provider (proximity) is determined without considering the availability aspect of spatial accessibility. the determination of accessibility was usually carried out by determining travel time. however, some studies used the line-of-sight measure, in which distances were used as a measure of access [ ] [ ] [ ] [ ] . this concept can be used in some scenarios as access to cars is one of the highest in the world for people residing in urban areas of australia, due to a highly developed road network [ ] . the second approach considers both aspects (availability and proximity); however, the limitation of using gravity models is a challenge for the determination of the distance-decay function [ , ] . the population versus provider services approach uses a classification of the population and health services within a defined region instead of the spatial movement as used in the other two approaches. the determination of the ratios is easy to compute, as the data for both the population and the health centers are usually available. the use of such an approach involves two assumptions: (a) that the population is expected to use health services within the defined region, and (b) that the proximity aspect is negligible within the region [ ] . the significant difference lies in the selection of defined regions. as the name suggests, the floating catchment area (fca) method uses floating areas or "windows" instead of defined regions, the size of which is determined by the availability of the required services within a region. the use of fca leads to the major challenge of not considering the demand aspect with respect to supply-demand concerns. this challenge was addressed by [ ] , which introduced the spatial decomposition method, and this approach was then used by [ ] , which introduced the two-step fca or sfca method. the sfca method is performed in two steps, first calculating the size of the population within the catchment area, and then determining the available services in the catchment area. evaluation of the accessibility of healthcare is usually conducted using gis techniques, which measure the travel distance and time required for using public or private transportation systems. the studies can be categorized as revealed accessibility or potential accessibility [ ] . revealed accessibility is the actual time taken to reach health centers, whereas potential accessibility analyses the potential to access healthcare determined using either gravity models or specialized gravity models like the sfca method. after collecting and determining the relevant health barriers, statistical models were applied to analyze the association of the factors with survivability along with the interrelationship of the barriers. the present review looks at the models used to understand the barriers to healthcare access for various diseases in australia. the aim is also to analyze survivability or outcomes in relation to the barriers. the review was conducted based on several categories including disease, study area, models used, number of patients, rural vs. urban, consideration for indigenous people, and the dataset (source and time period) used. the australian healthcare system is considered a hybrid model where people can purchase private insurance coverage along with the public insurance they already receive, making both public and private hospitals available [ ] . the vast geographical area of the country, varied residential locations and their uneven distribution of population, network of roads and traffic conditions and the allocation of hospital resources lead to an imbalance of health service access for the people [ ] . in terms of practicing physicians, australia has . per people, which is one of the highest in the world [ ] . it also spends the most on healthcare among the organization of economic cooperation and development (oecd) countries, which are a consortium of countries dedicated towards developing policies for various social and economic challenges [ ] . a detailed understanding of the australian healthcare system can be found in [ ] . it has been well established that following illness, health outcomes can get worse upon traveling a greater distance to health centers. similar bias is often visible among residents living in rural areas as compared to urban areas. the variation between survivability among rural and urban residents for various health cases has been analyzed by several studies [ ] [ ] [ ] . the rural population suffers from higher fertility and perinatal mortality rates compared to the urban population. the chance of health cases (e.g., diabetes, high cholesterol, cancer, heart disease) is higher than in the urban population, which lowers their life expectancy by years. the national rural health alliance found that the barriers dividing remote areas from major cities are enormous: for example, in the case of remote/very remote areas, over % of people reported not having a specialist nearby as compared to only % in the case of major cities. such startling differences are also present across different disease types and health visits. the geographical classification of the country is based on the australian statistical geography classification (asgc) framework provided by the australian bureau of statistics (abs) (figure ). this classification was initiated in ; prior to it the australian statistical geography standard (asgs) classification was used. the studies conducted determined the geographical location of their respective study region based on census classification, which has been modified over the years. the population can be based on either place of enumeration (based on the location on census night) or place of usual residence (based on the location where they usually live). the studies relating to healthcare access were conducted based on place of usual residence. before , the census was based on statistical local area (sla), which was changed to collection district (cd) level in the next census. for the census, the australian statistical geography standard (asgs) was used, in which the data were available at statistical area (sa ) level, which could be aggregated to higher spatial scales of geography. the remoteness of a place can be categorized into one of five classifications: major cities, inner regional, outer regional, remote and very remote [ ] . remoteness has been defined based on the asgc-ra (remoteness area) classification ( figure ). this classification determines the physical distance of a location and allows the quantitative comparison between metropolitan and rural regions. to compute asgc-ra, the accessibility/remoteness index of australia (aria+) score is determined. this is an index of remoteness with values ranging from zero (high accessibility) to (high remoteness) based upon the physical distance of a location from the nearest urban center according to census data on population size [ ] . the remoteness of a place can be categorized into one of five classifications: major cities, inner regional, outer regional, remote and very remote [ ] . remoteness has been defined based on the asgc-ra (remoteness area) classification ( figure ). this classification determines the physical distance of a location and allows the quantitative comparison between metropolitan and rural regions. to compute asgc-ra, the accessibility/remoteness index of australia (aria+) score is determined. this is an index of remoteness with values ranging from zero (high accessibility) to (high remoteness) based upon the physical distance of a location from the nearest urban center according to census data on population size [ ] . . the other critical factor while determining accessibility is socio-economic status (ses), which is based on the socio-economic index for areas (seifa) developed by the australian bureau of statistics (abs) and is a set of four indexes: the index of relative socio-economic disadvantage (irsd); the index of relative socio-economic advantage and disadvantage (irsad); the index of education and occupation (ieo); and the index of economic resources (ier). the seifa comprises five categories, which are: most disadvantage; above average disadvantage; average disadvantage; below average disadvantage; and least disadvantage [ ] . generally, a socio-economic index is assigned using area-based measurement, which tends to be biased and often inaccurate. this was highlighted by [ ] which used individual-based demographic data and compared survival disparity when considering local government area (lga) and cd classification in the new south wales region. the results highlight the underestimation of survival disparity with little variation when relative excess risk (rer) is calculated. factors like patient characteristics including smoking, employment, ethnicity, disability, indigeneity, stigma and discrimination have also been explored by researchers under various circumstances [ , ] . the covid pandemic has revealed new barriers and challenges for healthcare workers and patients affected by it. this has caused patients with several necessary and critical health conditions to prematurely die in several oecd countries. among the oecd countries, australia has conducted a commendable job in addressing the barriers for healthcare professionals. although the situation is still unfolding, a few research articles and news reports are attempting to understand the gravity of the situation. some have reflected on the emotional state of healthcare professionals [ ] , while others have suggested the importance of linguistic and communication barriers. in the australian context, lakhani [ ] a conducted spatial analysis to understand the most vulnerable populations in the melbourne region depending on their characteristics. finally, the survivability of patients is determined by utilizing either the overall survival or relative survival measures. overall survival is defined as an estimate of survival from the initiation of either the diagnosis or medication, whereas relative survival is defined as an estimate of net survival which measures the deaths specifically associated with cancer diagnoses [ ] . such risks are also dependent on ses. therefore, relative excess risk (rer) has been defined; this is the ratio of excess risk of death in a particular ses quintile compared to that of the reference (least disadvantaged) ses group, controlling the other factors. the other critical factor while determining accessibility is socio-economic status (ses), which is based on the socio-economic index for areas (seifa) developed by the australian bureau of statistics (abs) and is a set of four indexes: the index of relative socio-economic disadvantage (irsd); the index of relative socio-economic advantage and disadvantage (irsad); the index of education and occupation (ieo); and the index of economic resources (ier). the seifa comprises five categories, which are: most disadvantage; above average disadvantage; average disadvantage; below average disadvantage; and least disadvantage [ ] . generally, a socio-economic index is assigned using area-based measurement, which tends to be biased and often inaccurate. this was highlighted by [ ] which used individual-based demographic data and compared survival disparity when considering local government area (lga) and cd classification in the new south wales region. the results highlight the underestimation of survival disparity with little variation when relative excess risk (rer) is calculated. factors like patient characteristics including smoking, employment, ethnicity, disability, indigeneity, stigma and discrimination have also been explored by researchers under various circumstances [ , ] . the covid pandemic has revealed new barriers and challenges for healthcare workers and patients affected by it. this has caused patients with several necessary and critical health conditions to prematurely die in several oecd countries. among the oecd countries, australia has conducted a commendable job in addressing the barriers for healthcare professionals. although the situation is still unfolding, a few research articles and news reports are attempting to understand the gravity of the situation. some have reflected on the emotional state of healthcare professionals [ ] , while others have suggested the importance of linguistic and communication barriers. in the australian context, lakhani [ ] a conducted spatial analysis to understand the most vulnerable populations in the melbourne region depending on their characteristics. finally, the survivability of patients is determined by utilizing either the overall survival or relative survival measures. overall survival is defined as an estimate of survival from the initiation of either the diagnosis or medication, whereas relative survival is defined as an estimate of net survival which measures the deaths specifically associated with cancer diagnoses [ ] . such risks are also dependent on ses. therefore, relative excess risk (rer) has been defined; this is the ratio of excess risk of death in a particular ses quintile compared to that of the reference (least disadvantaged) ses group, controlling the other factors. in terms of diseases, numerous studies have been conducted for various types, of which the greatest number have been performed for cancer ( %), followed by primary health care ( %), dental care ( ) and cardiovascular conditions ( %). figure depicts the studies conducted for various diseases. in terms of diseases, numerous studies have been conducted for various types, of which the greatest number have been performed for cancer ( %), followed by primary health care ( %), dental care ( ) and cardiovascular conditions ( %). figure depicts the studies conducted for various diseases. studies focused on understanding the inequalities in healthcare access based on various traits like location (rural, urban), origin (indigenous, nonindigenous), and access to health services. among the various regions, most studies were performed in queensland ( %), followed by new south wales ( %), victoria ( %) and the entire country ( %). cancer is the most significant global public health problem and a leading cause of death and illness in the world in the st century, including australia [ ] . breast cancer is estimated to have been the most commonly diagnosed cancer in , followed by prostate cancer. the distribution of the studies related to cancer types has also been varied with most studies being conducted on colorectal cancer followed by breast, prostate and lung cancer. generally, the studies conducted form a framework in which barriers were analyzed independently as well as in terms of their interrelationship and their relationship with health outcomes. general accessibility factors like age, sex, patient characteristics and disease stage (incidence, various cancer stages) were collected from the respective state's cancer registry. the distance to the health facility was determined by geocoding the distance of all the facilities to the centroid of each sla or to the address of the patient if available. there seems to be a set framework when studying barriers to cancer care that considers various geographic and demographic parameters, thereby determining the survival rate. studies focused on understanding the inequalities in healthcare access based on various traits like location (rural, urban), origin (indigenous, nonindigenous), and access to health services. among the various regions, most studies were performed in queensland ( %), followed by new south wales ( %), victoria ( %) and the entire country ( %). cancer is the most significant global public health problem and a leading cause of death and illness in the world in the st century, including australia [ ] . breast cancer is estimated to have been the most commonly diagnosed cancer in , followed by prostate cancer. the distribution of the studies related to cancer types has also been varied with most studies being conducted on colorectal cancer followed by breast, prostate and lung cancer. generally, the studies conducted form a framework in which barriers were analyzed independently as well as in terms of their interrelationship and their relationship with health outcomes. general accessibility factors like age, sex, patient characteristics and disease stage (incidence, various cancer stages) were collected from the respective state's cancer registry. the distance to the health facility was determined by geocoding the distance of all the facilities to the centroid of each sla or to the address of the patient if available. there seems to be a set framework when studying barriers to cancer care that considers various geographic and demographic parameters, thereby determining the survival rate. the remoteness index (aria+) and socio-economic index are considered when determining the effects on patient survival. the models used to determine survivability included the poisson regression model [ ] and the cox proportional hazards model [ ] . survivability can be expressed in either a spatial [ ] or a temporal context [ ] . yu et al. [ ] used the poisson regression model to determine survivability by analyzing residential location in diagnoses of colorectal cancer. however, frowen et al. [ ] investigated the impact of pre-treatment factors including demographic parameters. baade et al. [ ] determined the survival rate among colorectal cancer patients residing in queensland. the study introduced a multilevel approach to assess area-level variation in colorectal cancer survival due to causative factors (disease stage, comorbidity, patient characteristics and healthcare access) and analyze their individual contribution to survival. baade et al. [ ] analyzed the relation between distances to radiotherapy facilities and survival outcomes for rectal cancer patients in queensland using the cox proportional hazards regression model. the results revealed that survival rate is low in areas of socio-economic disadvantage, remoteness and greater distance to radiotherapy facilities. hsieh et al. [ ] quantified the additional barriers that impacted treatment among women in queensland diagnosed with breast cancer. a bayesian spatial modeling approach was used to analyze the spatial inequalities of utilizing adjuvant therapy and found that socio-economic aspects did not play a significant role. however, the choice of therapy (radiotherapy, chemotherapy, hormonal therapy) was dependent on the age of the patient. coory et al. [ ] studied the disparity in cancer-related deaths among people residing in regional and remote areas for a period of years ( - ). they used an arithmetic methodology wherein the number of deaths precluded in australia and excess cancer deaths in regional areas were computed. the results revealed a slight improvement in curtailing the disadvantage of such areas, with a death rate lower than metropolitan areas. an interesting study was conducted in [ ] , which introduced a new parameter, "country of birth", along with socio-economic status, remoteness and ethnicity among patients diagnosed with cancer in the new south wales region. a logistic regression model was used to analyze the relation between variables and the distant summary stage. the results revealed that people born outside of australia were more likely to be diagnosed, with socio-economic status also playing a significant role. mahmud et al. [ ] used multivariate analysis to analyze the trends associated with cancer incidence, hospitalization, and fatality for several barriers. the study was conducted for the period - and the results revealed that socio-economic and geographical access play a significant role in patient outcome. even though there was improvement over the time period, significant improvements need to be made to improve the lifespan of people residing in regional areas. access to primary health care (phc) via general practitioners (gp) is critical as a key to improving health outcomes, with more than % of people visiting at least once every year [ , ] . access is quite varied among people residing in rural and urban areas and therefore the focus has been more on understanding access to phc in rural areas. it has been proven and accepted that with an increase in distance to health centers the utilization of such centers becomes less [ , ] . studies have primarily focused more on the spatial context. the sfca method has been heavily used to analyze barriers to primary health care services in australia for both small and large catchment areas. there have been several improvements in the use of the sfca approach studied in [ ] . these improvements include the addition of the distance-decay function and the variable distance-decay function. the distance-decay function included the consideration of distance/time when calculating barriers within a catchment area, whereas the inclusion of the variable distance-decay function considers situations in which travel distance is greater according to the health service required. such a situation is quite evident in rural areas where a patient may need to travel farther for a specific health service requirement as the services are sparsely distributed. this variation was explored in [ ] for the victoria region where the number of health services was limited to with a travel time of up to min. mcgrail et al. [ ] developed a national index of access which contributed towards an improved understanding of spatial accessibility, which helped locate areas with access disadvantages and could be used for proper health planning. similar studies were conducted [ , ] for five communities in the victoria and new south wales regions and the metropolitan adelaide region, respectively. the results revealed that travel behavior needs to be considered when analyzing accessibility. however, the variation was understood only by categorizing the population into rural and urban, which may not provide accurate results when analyzing a large study area. this was overcome by the same authors [ ] when they defined rules for selection of the catchment area with respect to travel time and the number of health services and performed the study for the entire country. the fundamental challenge of using the sfca method is the definition of catchment areas, and researchers have attempted to define new ways with the ability to accurately assess the disparity in access to gps in rural and urban regions [ ] . however, these studies failed to consider the socio-economic status of the population studied. this aspect was explored in [ ] , which was performed in the inner regional area of new south wales. the study applied a bivariate analysis to understand the relationship between remoteness and socio-economic status, leading to the construction of a composite score of deprivation. thereafter, a pairwise correlation matrix between the number of physicians, remoteness and socio-economic status was performed and validated with the health outcomes. the results revealed that socio-economic status plays a significant role compared to remoteness and physician numbers for determining risk per persons. schofield et al. [ ] utilized six different variables (sex, age, income, remoteness, health status, employment status) to understand gp access, focusing on people with low socio-economic status residing in rural areas. the results indicated that gp services do not depend on the per capita utilization of the services, irrespective of whether they are based in rural or non-rural areas. however, this relation may not be accurate when considering indigenous people. the inclusion of indigenous people in understanding barriers to accessing phc services was studied in [ ] , which highlighted the need for also considering indigenous staff as social and cultural biases may exist. gibson et al. [ ] conducted an in-depth study by reviewing articles related to the barriers faced by indigenous people when assessing phc. it is evident that primary health care is probably the most basic and frequently visited health service by the population regardless of region, ethnicity, and socio-economic status. therefore, it is imperative to understand the various barriers faced by every section of society. the focus has primarily been on understanding the association between remoteness and health outcomes. several other regions are yet to be explored with the focus shifting towards local areas and considering the social and cultural aspects of the population, which would provide an accurate understanding of these access barriers. the studies involving dental care were more focused on the spatial understanding of access barriers [ ] [ ] [ ] [ ] ] . the focus also seemed to be on analyzing the difference between public and private dental clinics, where roughly % of the population visit private clinics [ ] . most of the studies used the line-of-sight method to measure distances to dental care instead of determining travel time as they focused on metropolitan regions with a focus on using geospatial tools to identify accessibility [ , ] . the study in [ ] focused on private dental clinics in the western australia region and found that rural areas were more disadvantaged compared to the metropolitan areas. mcguire et al. [ ] conducted a study in victoria and found that almost three-quarters of the population resided within km of a dental clinic. almado et al. [ ] analyzed dental clinic accessibility for eight metropolitan cities of australia. the analysis revealed that only - % of people were able to avail of dental services depending on various capital city locations. however, an interesting study was conducted in [ ] analyzing the barriers faced by people with disabilities residing in adelaide. the study was analyzed using bivariate and multivariate models and the results revealed that access was poor for people with disabilities living in rural areas compared to people in community settings. the study also found that a significant barrier to accessing dental care is the unwillingness of dentists to treat disabled people. a similar study was conducted in [ , ] for homeless people in brisbane and identified fear as a barrier among the homeless population. mental health is essential but can be considered as the poorest service in terms of access, especially in rural and remote areas of the country [ ] . taylor et al. [ ] studied the state of patients experiencing mental health issues who needed to be transferred to metropolitan health centers. qualitative analysis was performed through interviews conducted among six patients and medical staff in the southern australia region to understand the barriers faced while transferring patients. fennell et al. [ ] conducted a similar study for adults living in rural parts of south australia and suggested that health professionals needed to be educated about these barriers. they also used evidence-based approaches to understand the concerns faced by patients. saurman et al. [ ] analyzed the mental health emergency care (mhec) rural access project implemented in new south wales ensuring h access to specialists over video conferencing using a concurrent mixed-methods approach. wohler and dantas [ ] conducted a review of the barriers faced by immigrant and refugee women when accessing mental health services in australia. the study highlighted that the barriers include factors like religion, self-reliance and resilience, suggesting that measures need to be undertaken to address these concerns. maas et al. [ ] conducted a spatial analysis using autocorrelation indexes and spatial regression to determine patterns of referral for a mental health program in the western sydney region. the results revealed that the distribution formed a pattern covering the areas with low socio-economic status. the factors affecting easy access to mental healthcare programs are varied and efforts need to be made to analyze the barriers at a local scale and implement steps to overcome them. however, the work surveyed clearly shows that indigenous people, remote areas and low-income people are the most affected. cardiovascular disease (cvd) contributes to almost % of deaths in the country and is the second most prevalent disease after cancer [ ] . this section discusses studies related to cardiovascular diseases and cardiac rehabilitation services. studies relied on gis to determine remoteness and accessibility. bamford et al. [ ] developed cardiac aria to quantify the accessibility of cardiac services via the available road networks. the significant difference between aria and cardiac aria lies in the selection of a location for accessibility modeling: aria uses population location whereas cardiac aria uses the location of the health service. cardiac aria measures travel time to relevant health centers in two categories: (a) acute cardiac aria, which determines the travel time by ambulance in the event of an acute cardiac arrest, and (b) aftercare cardia aria, which evaluates the travel time by private transport after hospital discharge. coffee et al. [ ] calculated the cardiac aria index for the entire country based on both categories and concluded that the current system provides timely access for the majority of the population. cardiac rehabilitation serves as a primary step for preventing cvd and access to it has been a major concern, especially in remote areas [ ] . higgins et al. [ ] reported that the percentage of people attending rehabilitation programs after coronary artery bypass graft surgery varied from - % and identified the lack of effective referral protocols as a major factor. they based their study on patients admitted to the royal melbourne hospital, victoria, and used a logistic regression model to determine patient characteristics as well as visiting the rehabilitation programs. the uneven distribution of cardiovascular services in the country was highlighted in [ ] , which argued that barriers are not only confined to distance and transport reliability but are multidimensional, involving other socio-economic parameters. van gaans et al. [ ] developed the spatial model of accessibility, involving both the geographic and the socio-economic factors. the model determined ratings based on the patients who enrolled in the program versus completion rate of the program. the other diseases where the relation between barriers and the health outcome was studied included obesity, kidney transplants, diabetes, strokes, and services such as clinical trials and maternity. the number of people who are obese has increased drastically over the last three decades [ ] . remoteness and socio-economic disadvantage have been found to be the most critical factors affecting obesity [ , ] . the relationship between these factors and body mass index among australian immigrants was studied using statistical analysis in [ ] . in terms of wait listing for kidney transplantation, [ ] studied the various barriers faced by patients. the study was conducted using univariate and multivariate models and found that access to the waitlist is based on numerous factors like sex, ethnicity and remoteness. the disparity between indigenous people and nonindigenous people in kidney transplant accessibility was studied by [ ] . statistical analysis including the cox proportional hazards model was used to understand this disparity. scott et al. [ ] used regression models to analyze the demographic relationship with healthcare service coverage for the hepatitis c virus. the results revealed that despite the cost of the drug being low, more than % of the geographical area treated less than % of people suffering with the virus. gilbert et al. [ ] conducted a qualitative study to understand the barriers faced by patients when accessing cataract surgery. they found five significant parameters, i.e., travel time, reputation of the health center, surgeon experience, cost and the wait time for surgery. sabesan et al. [ ] analyzed the willingness for clinical trials among rural and regional patients in north queensland. using data from patients and statistical analysis, they found that rural patients are more willing compared to the urban patients. zdenkowski et al. [ ] analyzed the barriers faced by patients when enrolling in a clinical trial for cancer medication. the study was performed by conducting interviews among people under various scenarios ranging from variation in travel time, change in oncologist, trial type and increase in cost. logistic regression was used, and the results revealed that if the cost and the oncologist remained same, the willingness of participants were greater. however, an increase in travel time led to a decrease in participation, whereas there was no difference concerning trial type. the outcome of this review could be useful for researchers for understanding the various modeling approaches used for understanding barriers to healthcare access in australia and could also be used in other countries with similar diversity. it provides a broad understanding of the techniques being used, which could serve as a starting point for researchers looking to work in this domain for the first time. the analysis can be useful for identifying some existing shortcomings and the important research questions to be addressed in the future. the findings from the study are illustrated in figure , which depicts three different domains on which the present article has focused, with the various barrier types, the models used to understand the barriers and the diseases for which the study has been conducted. after analyzing all the components of the different domains, we conclude by summarizing the current focus of the research study and providing future directions on which research should focus. the first gap is the need to focus on other diseases than cancer. primarily, more research has been conducted towards cancer, which is understandable due to the high number of patients suffering and the rate of fatality. however, more efforts need to be put towards focusing on other major health issues. the second issue is the lack of studies on a finer scale, as most of the studies conducted were either of an entire state or of the whole country. certain barriers for a specific disease type are pertinent at a local level and their effect on accessibility is also critical. therefore, emphasis should be on moving towards understanding barriers at a local scale. the covid pandemic has shown the gaps present in the healthcare system in dealing with infectious diseases and our lack of research towards handling barriers for both patients and healthcare workers. although the australian health system has considerably performed well compared to other economically developed countries, our understanding of the relevant barriers needs to be comprehensively studied ahead of future infectious disease outbreaks. in general, the main barriers are providing sufficient testing capacities, emotional and physical stress among the health workers and the dispersion of accurate information among the general public. in understanding various healthcare barriers, accessibility, specifically spatial accessibility, is one specific area where a lot of improvements can be made. the spatial mobility aspect can be considered as the most significant barrier to healthcare access. while the topic has been very well studied in the fields of traffic monitoring and congestion, its application to healthcare studies in australia has been limited. in terms of the spatial accessibility of health facilities, it can be broadly categorized into two sections: (i) navigation to health centers, which could be proximity to the health center as well as distance or travel time between a certain location and the health center, which would be critical in cases of medical emergencies, (ii) setup of new health facilities, which can be achieved by considering the population demand according to the diseases being suffered from along with the first gap is the need to focus on other diseases than cancer. primarily, more research has been conducted towards cancer, which is understandable due to the high number of patients suffering and the rate of fatality. however, more efforts need to be put towards focusing on other major health issues. the second issue is the lack of studies on a finer scale, as most of the studies conducted were either of an entire state or of the whole country. certain barriers for a specific disease type are pertinent at a local level and their effect on accessibility is also critical. therefore, emphasis should be on moving towards understanding barriers at a local scale. the covid pandemic has shown the gaps present in the healthcare system in dealing with infectious diseases and our lack of research towards handling barriers for both patients and healthcare workers. although the australian health system has considerably performed well compared to other economically developed countries, our understanding of the relevant barriers needs to be comprehensively studied ahead of future infectious disease outbreaks. in general, the main barriers are providing sufficient testing capacities, emotional and physical stress among the health workers and the dispersion of accurate information among the general public. in understanding various healthcare barriers, accessibility, specifically spatial accessibility, is one specific area where a lot of improvements can be made. the spatial mobility aspect can be considered as the most significant barrier to healthcare access. while the topic has been very well studied in the fields of traffic monitoring and congestion, its application to healthcare studies in australia has been limited. in terms of the spatial accessibility of health facilities, it can be broadly categorized into two sections: (i) navigation to health centers, which could be proximity to the health center as well as distance or travel time between a certain location and the health center, which would be critical in cases of medical emergencies, (ii) setup of new health facilities, which can be achieved by considering the population demand according to the diseases being suffered from along with considering other factors like affordability, and indigenous status. for both these aspects, the use of gis integrating with the transport model and the concept of spatio-temporal paths should be encouraged [ ] . the effects of spatial accessibility during the pandemic outbreak have revealed some serious gaping holes in the system and its decisionmakers. while the studies in the australian context focused more on the use of the sfca and other statistical models to calculate distance to health centers, focus should shift towards considering different techniques, e.g., the three-step floating catchment area ( sfca), which uses distance, proximity and population demand. it could also help in identifying disparities in healthcare access in a regional-level study. apparicio et al. [ ] analyzed the accessibility of health services using various distance and aggregation methods. such analysis needs to be performed at various spatial scales (national, regional and local) to standardize the basic methodology to be used, which can then be improved in the future. in addition, the input data used for conducting similar studies rely heavily on google earth/maps or openstreetmap. efforts need to be made to use a high spatial dataset [ ] which would improve the spatial mobility significant in health scenarios. such use of a high spatio-temporal dataset would help in identifying the nearest health center along with the shortest route to reach it considering population density [ ] . this would immensely support decisionmakers and stakeholders in gaining better access to health centers. the recent work in [ ] on determining distance and travel time for helsinki, finland using several transportation modes provides a model for deciding the travel mode to be used in cases of medical emergency, clinical check-up and rehabilitation. such development of a disease-specific travel time dataset, e.g., check-ups for breast and prostate cancer, dental care and gps, could better aid people in deciding which health facility to go to. it has been well acknowledged that remote areas suffer from an inadequate number of health centers, but the type of health centers for a specific disease type is also quite erratic even in urban areas. although the specialized field of analyzing the setup of new health centers is a separate entity, we attempted to look at it solely from the different barrier point of view. the lack of facilities can be overcome by setting up new facilities, but the challenges could range from accessibility to cultural difficulties and affordability. the accessibility component can be solved by utilizing the measures mentioned above; however, the other challenges would be detrimental which could be understood by conducting interviews and understanding specific requirements at a community level. the challenge lies in setting up new health centers specific to community-based barriers with the consideration of socio-economic status as well as cultural and regional biases. the steps to set up a new health center could begin with the understanding of broader aspects like accessibility and affordability, and thereafter fill in the gaps of cultural differences with the capacity to upgrade in the future. another important aspect found while conducting this review was the comparison between rural and urban healthcare accessibility, with a few studies comparing different metropolitan regions. however, comparison between accessibility and health outcomes among the rural regions in a state or across several states was not heavily researched. such analysis would be interesting to understand which states struggle to provide rural healthcare services and thereafter necessary steps can be taken by the respective state health departments to improve these services. care must be taken when analyzing the rural regions as patient characteristics like indigeneity, cultural and linguistic barriers would be critical when addressing rural health issues. this review paper is an attempt to analyze the models used in understanding barriers to healthcare access and the survivability of the patient across various disease types. current research practice is lacking in various domains ranging from spatial accessibility techniques to the consideration of patient characteristics and the analysis of different disease types as well as studies concerning only rural/remote areas. additionally, our understanding of the barriers for infectious disease outbreak is still in infancy and the covid situation would help in determining the various concerns among patients and health workers that should be considered in the future. the study highlighted the key areas on which research has focused: cancer and primary health care-related studies, the sfca method and rural vs. urban health outcomes. the conclusions from the study are as follows: • it is important to note that the barriers are multifaceted, of which the major ones are geography, ethnicity and socio-economic status. the most deprived section for healthcare access is indigenous people, and this could be even worse if their economic status is poor. the focus needs to shift towards addressing cultural and linguistic barriers, especially for indigenous people. there are also several other barriers which are specific to the disease the patient is suffering from. as most studies have focused on a large geographical area, the distance/time determination using the smallest administrative boundary for better accuracy has been missed. the emphasis should be on analyzing at the smallest administrative boundary. the focus has also primarily been on a few diseases only, such as cancer and primary health care, and the location of the study has focused primarily on a few states only. both aspects need to be improved, the type of disease and the study area. the distance/time calculation to health centers is determined spatially using gis and various geospatial tools. it is encouraging that the available models, such as the sfca method, have been tested very extensively for different regions and have been proved to be performing well. however, new models and techniques like sfca and machine learning need to be attempted for better accuracy. the increase in the availability of data would help in developing machine learning-based tools aimed at identifying key shortcomings and the steps needed to be taken for better healthcare access at both local and regional scales. geographical access to health care. in access health care are differences in travel time or distance to healthcare for adults in global north countries associated with an impact on health outcomes? a systematic review understanding shortages of sufficient health care in rural areas the distribution of 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in helsinki region this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license key: cord- -h ok authors: olea-popelka, francisco; fujiwara, paula i. title: building a multi-institutional and interdisciplinary team to develop a zoonotic tuberculosis roadmap date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: h ok tuberculosis (tb), as the major infectious disease in the world, has devastating consequences for not only humans, but also cattle and several wildlife species. this disease presents additional challenges to human and veterinary health authorities given the zoonotic nature of the pathogens responsible for the disease across species. one of the main public health challenges regarding zoonotic tb (ztb) caused by mycobacterium bovis is that the true incidence of this type of tb in humans is not known and is likely to be underestimated. to effectively address challenges posed by ztb, an integrated one health approach is needed. in this manuscript, we describe the rationale, major steps, timeline, stakeholders, and important events that led to the assembling of a true integrated multi-institutional and interdisciplinary team that accomplished the ambitious goal of developing a ztb roadmap, published in october, . it outlines key activities to address the global challenges regarding the prevention, surveillance, diagnosis, and treatment of ztb. we discuss and emphasize the importance of integrated approaches to be able to accomplish the short (year ) and medium term (year ) goals outlined in the ztb roadmap. worldwide, there is consensus that solutions to complex issues need the participation and involvement of different stakeholders. recent outbreaks of emerging and re-emerging zoonoses [i.e., zika, ebola, middle east respiratory syndrome (mers), avian and swine influenza] ( ) have heightened the public's awareness about the close and complex interrelationship between the health of humans, wildlife species, and domestic animals. tuberculosis (tb), is one such disease that continues to have devastating consequences for not only humans, but also cattle and several wildlife species ( ) ( ) ( ) ( ) . caused by bacteria belonging to the mycobacterium tuberculosis complex (mtbc), tb presents additional challenges to human and veterinary health authorities given the zoonotic nature of the pathogens responsible for the disease and the ability of mtbc agents to be shared across species ( , ) . tb in humans is caused primarily by mycobacterium tuberculosis (m. tb); worldwide, it is the leading cause of death in humans by an infectious disease ( ) . bovine tb caused by mycobacterium bovis (m. bovis) is widely distributed around the world ( , ) and continues to cause considerable economic losses to farmers and countries due to the reduced production of affected animals, culling of animals from herds (or entire herd depopulation in some cases), and the elimination of affected (or all) parts of animal carcasses at slaughter ( ) . m. bovis can also infect and cause tb in humans (zoonotic tuberculosis (ztb) ( ) ( ) ( ) ( ) . the world health organization (who) estimated that "in there were , new cases of ztb and , deaths due to this type of tb" ( ) . furthermore, m. bovis has the ability to cause tb and cause death in several wildlife species ( , ) . one of the main public health challenges regarding ztb is that its true incidence in humans is not known and is likely to be underestimated due to the lack of systematic surveillance for m. bovis as a causal agent of tb in people in all low-income, high tb burden countries where bovine tb is endemic, and the inability of laboratory procedures most commonly used to diagnose human tb to identify and differentiate m. bovis from m. tb ( ) . to effectively address challenges posed by ztb (and other diseases at the "animal-human" interface), a crosssectorial and multidisciplinary one health approach linking animal, human, and environmental health is required. in this manuscript, we describe the rationale, major steps, timeline, stakeholders, and important events that lead to the assembling of a true integrated multi-institutional and interdisciplinary team that worked toward and accomplished the ambitious goal of developing a ztb roadmap that was published in english, spanish, and french ( ) ( ) ( ) to address the global challenges regarding the prevention, surveillance, diagnosis, and treatment of zoonotic tb (ztb), globally. we discuss and emphasize the importance of integrated approaches to be able to accomplish the short (year ) and medium term (year ) goals outlined in the ztb roadmap. the international union against tuberculosis and lung disease (the union) is an international scientific organization that works with partners, including governments, academia, and civil society, to fight tb, tobacco use and other lung diseases in low-and middle-income countries, through technical assistance, training, and research. through its volunteer members, it houses scientific sections that promote areas of specific interest. the union's ztb sub-section is a global network of physicians, veterinarians, researchers, economists and social anthropologists that works to understand the dynamics of ztb, create global awareness, and facilitate multi-institutional collaboration to address the challenges posed by it. efforts conducted by the ztb sub-section has led to a continuous and stable increase in the number of activities, attention, and attendees to ztb-related activities at the annual union world conference on lung health. for example, at the conference in berlin, germany, there was only one ztb session (symposium) attended by less than people. over the last seven years, the ztb activities at the annual conference have increased to two scientific symposia, one poster session, one meet the expert session, press releases, and a keynote talk on ztb at the plenary session in south africa during the conference. during the last conference in guadalajara, mexico in october , an audience of approximately professionals from different disciplines attended each of the two ztb scientific symposia. prior to the union's initial activities to create global awareness of ztb, in , the who, oie and fao pioneered one health approaches under a tripartite partnership, which shares responsibilities and jointly develop and implement integrated strategies for addressing health risks at the human animal-ecosystem interface ( ) . the combined involvement and commitment of these three institutions has been crucial to successfully develop a ztb roadmap since these institutions jointly: ( ) provide global leadership for tb prevention, care and control (who); ( ) is responsible for improving animal health and welfare (oie); and ( ) work toward improving food security, nutrition and agricultural productivity and reduce rural poverty (fao). in march , the ztb sub-section created a working group to raise awareness of the public health risk posed by ztb. this working group included participants from key parties including the: one of the accomplishments of this working group was the publication of a manuscript ( ) calling for a call to action in the lancet infectious disease journal. a constellation of events has occurred to bring ztb to the awareness of scientists, policymakers, government officials and the general public. in may , the world health assembly, who's yearly gathering of the world's ministers of health, approved the new post- global tb strategy. the strategy aims to end, rather than merely control, the global tb epidemic, with targets to reduce tb deaths by % and to reduce new cases by % between and , and to ensure that no family is burdened with catastrophic expenses due to tb. it set interim milestones for , , and ( ) . thus, finding and treating every case of tb, whether caused by m. tb or m. bovis, will count toward the achievement of this ambitious goal. for this reason, as countries move toward detecting the million tb cases estimated to be missed annually, and in light of the endorsed who "end tb" strategy, the tripartite, the union and the key organizations concerned with human and animal health, agriculture and tb joined forces to develop a zoonotic tb road map outlining medium-and long-term milestones to globally address the prevention, surveillance, diagnostic, and treatment challenges faced by persons with ztb. in september , the united nations declared the end of the millennium development goals and used them as the foundation for the sustainable development goals (sdgs) ( ) for - , encompassing broad and comprehensive topic areas, ranging from elimination of poverty and hunger, improved education and gender equality, to clean water and energy, action on climate and improvement of life under water and on land. the third sdg addresses global health, with tb highlighted as one of the priorities, thus presenting a key opportunity to improve the health of communities affected by ztb. the stop tb partnership, the global advocacy organization for tb, published the th edition of its global plan to end tb, - entitled "the paradigm shift" ( ) . this is a costed plan that includes actions needed to decrease tb, and is in full support of who's end tb strategy. the global plan has set its -( )- targets, which are to: identify % of all tb cases; concentrate on identifying % of those in key populations; and ensure % obtain appropriate treatment until cure. for the first time in this document, communities and people at risk of contracting ztb were included as a key population. a meeting co-organized by who and the union, with contributions from leading international organizations for human and animal health, academic institutions, and nongovernmental organizations took place at who in geneva. there, the first steps toward formally conceptualizing a roadmap for ztb began, in which ten priorities were identified to be presented to who's global tb programme's strategic technical advisory group (stag) for tb in june . in addition to the institutions initially working on increasing global awareness of ztb, the following institutions joined the efforts at this specific meeting: -swiss tropical and public health institute, switzerland -animal and plant health agency (apha), united kingdom -university of ibadan, nigeria -the global research alliance for bovine tuberculosis (grabtb) the involvement and participation of grabtb was an important addition and played a strategic role in partnering with colleagues focusing in improve the understanding and control of bovine tb and developing novel and improved tools to control the disease at its bovine source ( ) . grabtb was established in and as part of its strategic goals, the alliance seeks not only to enhance collaboration within its members and institutions, but also with the broader human and animal tb research community. the priorities proposed for the ztb roadmap were endorsed by the stag, and a working group was created and tasked to produce and publish a ztb road map during . at the stag meeting, a former ztb survivor, from the masaai community in kenya shared with the scientific community the challenges she faced while suffering from this disease, which included: initial misdiagnosis, development of extrapulmonary (abdominal) tb, antimicrobial resistance to anti-tb drugs additional to the inherent resistance m. bovis has against pyrazinamide, and the need for longer ( months) antimicrobial treatment, compared to the standard of months. during the th union world conference on lung health in liverpool, england, a british veterinarian and former ztb patient/survivor also shared his experience and challenges of initial misdiagnosis, extrapulmonary (pleural) tb, drug resistance to isoniazid in addition to pyrazinamide, and the longer treatment required while battling ztb in the year . these patients' testimonies further emphasized that ztb is not a disease from the past, and highlighted the challenges faced by certain communities at higher risk of contracting ztb. both patients emphasized the need of more awareness among the medical community to better diagnose and treat ztb patients, and thus prevent the additional complications they had to endure. the heads of state comprising the g forum declared that "shaping an interconnected world, calls for a one health approach to tackling the spread of antimicrobial resistance and highlighted the need to foster research and development for tb" ( ) . the roadmap for ztb was published and launched at the union world conference for lung health in guadalajara, mexico. the roadmap is the product of efforts of the tripartite partnership on zoonotic diseases comprising who, oie, and fao and the union, and is available in english, french, and spanish ( ) . the role of media over the past years, all efforts, activities, and events related to ztb were highlighted by a considerable number of local, regional, national, and global media sources including central news network (cnn), the british broadcasting corporation (bbc), and le monde newspaper in france, to name a few. the zoonotic tb roadmap ( ) outlines priorities to address the existing challenges posed by ztb, divided into three major core themes: ( ) improve the scientific evidence, ( ) reduce transmission at the animal-human interface, and ( ) strengthen intersectoral and collaborative approaches. "identify opportunities for community-tailored interventions that jointly address human and animal health interventions that jointly address human and animal health can increase health and economic benefits for communities. sharing of human resources, equipment and transport across sectors can reduce operational costs. this increased cost-effectiveness is especially relevant given the public funding constraints that often exist in settings where people are most at risk of zoonotic tb. for example, outreach childhood immunization campaigns or other existing livestock vaccination or testing programmes conducted in rural communities could be used to concurrently deliver educational and behavior change messages about food safety, to test livestock for bovine tb or, potentially in the future, to implement livestock vaccination campaigns against bovine tb. interventions must be tailored to the cultural and socioeconomic characteristics of each setting. community-driven participatory initiatives are key to achieving sustainability." table | timeline for action and milestones to be achieved in the short ( ) and medium term ( ) outlines in the ztb roadmap ( ) . reduce transmission at the animal-human interface although the publication of the ztb roadmap represents an unprecedented and historical accomplishment in the fight against global tb ( ) , there is still much work to be conducted in order to implement the actions needed to improve the prevention, diagnosis, control and treatment of ztb. table is an excerpt from the ztb roadmap in which the short (year ) and medium term (year ) milestones to be accomplished are outlined under the three core themes of the roadmap. one of the key elements toward accomplishing these goals is that the unique cultural and socioeconomic factors that shape the relationship between people, livestock, and wildlife species in different ecosystems must be taken into account, while including the at-risk communities in future efforts to reduce the risk of zoonotic transmission of m. bovis across species. these efforts not only need to focus on preventing transmission from livestock (mostly cattle) to humans, but also, and in parallel, to reduce the prevalence of the disease in both domestic and wildlife species. the availability of improved diagnostic tools for ztb in different species, as well as the implementation of disease monitoring, surveillance, and prevention strategies in livestock and wildlife species will be a crucial and much needed component to be able to implement comprehensive programs that will account for the complexities ztb poses due to its zoonotic nature. finally, including vaccination of wildlife (where feasible), not only has the potential for reducing the burden of disease, but also could play an important role in conservation efforts, especially among endangered and protected species. implementing an integrated approach to develop the ztb road map did not come without the inherent challenges of multidisciplinary and multi-institutional projects. that said, the accomplishment of this milestone in the fight against tb was the vision of a world free of tb, no matter what its source, the strong support of who and the stop tb partnership, a motivated core group that drove the process by providing clear goals and timelines, being inclusive by inviting all interested parties, and fostering a strong commitment to work together from colleagues and institutions both from the human and animal sectors that previously were working in isolation. this collaboration has opened new doors and opportunities as the world fights to end tb. all authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication. the national institute for occupational safety and health (niosh): emerging infectious diseases world health organization report of the meeting of the oie ad hoc group on tuberculosis, annex of the oie scientific commission for animal diseases report -september one health in the shrinking world: experiences with tuberculosis at the human-livestock-wildlife interface evidence of increasing intra and inter-species transmission of mycobacterium bovis in south africa: are we losing the battle? available online at mycobacterium bovis infection and control in domestic livestock zoonotic tuberculosis due to mycobacterium bovis in developing countries zoonotic mycobacterium bovis-induced tuberculosis in humans current knowledge and pending challenges in zoonosis caused by mycobacterium bovis: a review zoonotic tuberculosis in human beings caused by mycobacterium bovis -a call for action why has zoonotic tuberculosis not received much attention? world health organization, world organisation for animal health, food and agricultural organization of the united nations world health organization, world organisation for animal health, food and agricultural organization of the united nations, the international union against tb and lung disease. hoja de ruta contra la tuberculosis zoonotica world health organization, world organisation for animal health, food and agricultural organization of the united nations, the international union against tb and lung disease available online at united national sustainable development goals (sdgs) global plan to end tb: the paradigm shift g leaders declaration: shaping an interconnected world a roadmap for zoonotic tuberculosis: a one health approach to ending tuberculosis in addition to the institutions listed on the manuscript the authors wish to acknowledge the work of additional institutions that contributed to the development of the ztb roadmap: servicio key: cord- -o biwypo authors: asai, atsushi; okita, taketoshi; ohnishi, motoki; bito, seiji title: should we aim to create a perfect healthy utopia? discussions of ethical issues surrounding the world of project itoh’s harmony date: - - journal: sci eng ethics doi: . /s - - - sha: doc_id: cord_uid: o biwypo to consider whether or not we should aim to create a perfect healthy utopia on earth, we focus on the sf novel harmony ( ), written by japanese writer project ito, and analyze various issues in the world established in the novel from a bioethical standpoint. in the world depicted in harmony, preserving health and life is a top priority. super-medicine is realized through highly advanced medical technologies. citizens in harmony are required to strictly control themselves to achieve perfect health and must always disclose their health information to the public and continuously prove their health. from a bioethical standpoint, the world in harmony is governed by a “healthy longevity supremacy” principle, with being healthy equated to being good and right. privacy no longer exists, as it is perceived ethical for citizens to openly communicate health-related information to establish one’s credibility. moreover, there is no room for self-determination concerning healthcare because medical interventions and care are completely routinized, automated, centralized, and instantly provided. this is a situation where the community exhibits extremely powerful and effective paternalism. one can argue that healthy longevity is highly preferred. but is it right to aim for a perfectly healthy society at all costs? should we sacrifice freedom, privacy, vivid feelings, and personal dignity to achieve such a world? in our view, the answer is no, as this would require the loss of many essential values. we conclude by proposing an alternative governing principle for future healthcare, and refer to it as the “do-everything-in-moderation” principle. tuan kirie, a -year-old woman, is the main character of harmony. this work is told in the first person of tuan. it is the year , and tuan is a world health organization (who) monitoring officer who protects people's right to life. her job is to ensure that society guarantees healthy and humane lives for its members and to intervene when necessary. tuan describes her mission as follows: we are basically a flag-waving troop of diplomats-cum-peacekeepers charged with the protection of life everywhere… [t] o check whether they were ensuring their populace a lifestyle that was sufficiently healthy and human. (p. ). she was ordered to temporarily return to japan by her boss after a certain incident. shortly afterwards, more than people around the world attempted suicide simultaneously, and people, including one of tuan's best friends from high school, were successful in the attempt. an unidentified criminal declares to all citizens in the world: within the next week, i want you each to kill at least one other person… those who are unable or unwilling to perform this small task will die. (p. ). the main story in harmony concerns tuan kirie's investigation into the cause of the multiple suicides and identification of the person who issued the one-man-one-kill order. harmony's world is governed by an ideology referred to as lifeism (project itoh's coinage). lifeism is explained as being a politically enacted policy or tendency to view the preservation of health as the community's highest responsibility (p. ). harmony's world consists of communities which include people who have reached a consensus on a particular medical system and these medical conclaves are referred to as administrations (project itoh's coinage) (p. ). the medical conclaves (or administrations) have successfully realized super-medicine that uses advanced medical technologies including ai, ict, and nanotechnology. based on the welfare societies of the twenty-first century, this means the inclusion at adulthood of a constant internal monitoring network through a device called watchme, the establishment of a high-volume medical consumer system with affordable medicine and medical activities, and the provision of proper nutrition and lifestyle advice designed to mitigate predicted lifestyle-related illnesses. these activities are seen as the basic minimum conditions for human dignity (p. ). community groups cover % of the world (p. ), but some areas do not belong to a medical consensus community. for these %, super-medicine has nothing to do with citizens' lives. those who live outside medical conclaves are just like usthey catch colds, get headaches, get cancer, and die around the age of sixty or seventy (p. ). on the other hand, in medical conclaves, all people install watchme by injection into their bodies when the body finishes growing, i.e., when they become adults. watchme constantly monitors the level of rna transcription errors and immunological consistency in human blood at the molecular level. based on data sent from watchme, a little pharmaceutical factory in every household called medicare (personal medical drug purification system) synthesizes substances called medicule (project itoh's coinage) needed to eliminate pathogenic substances in the blood, and sends medicule, in a matter of milliseconds, to the area where the abnormality occurred at pinpoint and eliminates substances harmful to the human body. medicule can also issue a warning via measuring homeostasis in the body (p. ). as a result, swarms of medicines have essentially eliminated most diseases off the face of the planet (p. ). medicare performs autonomous, automatic, and instant medical interventions. medical treatments are nearly perfect and citizens' health management is almost completely realized. interestingly, healthcare professionals do not appear in the novel at all. a healthy longevity world has been established where no one is ill, the elderly are extremely active and healthy, and no one dies except in accidents or due to senility. in addition, each person's life is designed together with a health consultant. it is the extreme health-conscious society (p. ). in harmony's world, there are no interventions based on scientific technologies such as nanotechnology, let alone devices for monitoring the brains of community members. watchme is not designed to directly monitor mental activities, nor is medicule able to pass through the blood-brain barrier. behavior modification is attempted by request for self-restraint via traditional educational methods and social pressure. promotion of healthy behavior, and improvement of the environment by eliminating factors that could adversely affect mental and physical health, also lead people to live a healthy life. good health and health efforts are awarded high social assessment points, further motivating people to make efforts toward self-restraint. watchme warns people when a disturbance in the autonomic nervous system is detected and blocks harmful information, which also helps maintain peace of mind. children and young adults who cannot tolerate health education or the demand to live a public life attempt suicide or self-harm, as discussed later in sect. , unrelated to the aforementioned incident by the unidentified criminal. suicide that occurs frequently in this society is interpreted as a rebellion against controlled mental health by individuals who suffer from feelings of disillusionment and despair toward society, as well as hopeless, disconsolate feelings and a sense of entrapment. the above-mentioned medical conclaves were born after reflecting on a frightening history. in , a riot in the united states led to ethnic slaughter, and nuclear warheads spread around the world during the ensuing turmoil. this led to frequent nuclear terrorism, and radiation led to the development of cancer in many people. in addition, an unknown virus was generated due to the radiation, and many people succumbed to it and fell ill. this event is referred to as "maelstrom," meaning "the great disaster." the world in the face of an imminent health crisis established medical conclaves overnight. now, most parts of the world are free from chaos, savage, and slaughter, and a utopian world of peace, healthy longevity, and love has been realized (p. ). as it becomes apparent during the course of the story, harmony's world adopts an oligarchy political system; % of humans are basically under the watchful eye of a select group of people (p. ). this group refers to itself as the next-generation human behavior monitoring group. group members (i.e., leading senior citizens of medical conclaves, highest authorities of the medical industrial complex, and some scholars and scientists) have no intention of exploiting members of medical conclaves and created the healthy longevity society purely based on good intentions. they are solely dedicated to preventing the return of "maelstrom," and have the noble intentions of ensuring healthy longevity and world peace. no malice exits and the rulers remain concerned that all it would take is one mishap for cancers and viruses to return (p. ). we present here a brief overview of the history of medicine and medical development which are relevant to harmony's world. progress in medicine has provided solutions to various diseases including infectious diseases, genetic disorders, malignant tumors, and cerebrovascular disorders, and brought about mental stability to many people. all of these medical advances are cornerstones of the medical technologies used in harmony's world. in fact, a comparison between modern-day medical care that has evolved over the past years to that of harmony's world reveals a number of similarities. for example, wearable wireless devices that measure and display vital signs, steps, calorie consumption, and other variables have been in widespread use, with smartphones providing health guidance. continuous blood glucose monitoring devices have also been put into practical use. the use of "digital pills" started, in which a patient's medication status and physical condition are monitored by a sensor patch and ingestible sensor and sent to a central server and physicians, and improvement in medication adherence is attempted via guidance feedback. digital medicine includes a wide range of devices, such as temperature-monitoring foot mats capable of automatically detecting diabetic foot ulcers or clinically validated smartphone apps for smoking cessation combined with video tutorials and nicotine replacement therapy (ohta ; martani et al. ; biesen et al. ) . behaviors of members of the public are monitored, recorded, and aggregated for the purpose of preventing the spread of infectious diseases using smartphone location information and surveillance cameras. anti-cancer therapy with a drug delivery system using nanomolecules created by nanotechnology, micro-sample diagnosis, medical treatment by nano-robots, diagnosis/drug selection/prediction of disease onset based on genome analysis, gene manipulation by crispr/cas genome editing in fertilized eggs, and organ regeneration by regenerative medicine technology have also begun (sekai-cyoukan ; kanaya and ichikawa ; kobayashi ; johnston et al. ; sunshine and paller ; king and bishop ; itai ); medicule and genetic-level repairs of abnormalities described in harmony' world are beginning to be realized. the development of diagnostic systems using ai deep learning which had made a substantial breakthrough in the past decade is another active area of research. medical ai is used to carry out pathological diagnosis, diagnostic imaging, endoscopic diagnosis, diagnosis of and critical care for rare and intractable diseases, prediction of patient prognosis, and big data management. ai robots also provide nursing care. direct-to-consumer medicine using a digital healthcare application has also been put into motion (susskind and susskind ; kirinuki-sokuho ) . many countries guarantee affordable healthcare and good access to medical care through universal health care systems. in japan, the health promotion act ( ) states that citizens are responsible for health promotion, as well as local governments and the state, thereby setting the stage to support healthy lifestyles and promote behavior modifications. simultaneously, the act prescribes environmental maintenance to prevent passive smoking in society ). thus, we would argue that harmony's world is an sf story depicting a "brave healthy world" and can also be regarded as a speculative fiction about a health promoting society. as mentioned above, medical conclaves in harmony's world covers % of the world population and exclusively aim to promote healthy longevity and life retention. harmony's world devotes itself to realizing the health-supremacy principle and healthism, and this leads to various problematic issues, which are discussed in detail below (table ) . we can gain insight into important lessons about ethical, social, and psychological issues of our future world with strong health orientation by analyzing harmony's world in detail. first, the extreme healthoriented and health-conscious society has given rise to health worship. in this world, healthy longevity is considered more important than anything else. health the value we call health is trampling us over everything else. it means that the flood is coming. we are about to drown. (p. ). another one of tuan's colleagues, who is critical of the excessive health-oriented society, mentions: since we are both here on business, we don't have to worry about oil or cholesterol or any moral concerns. let's eat! (p. ). here, we note that cholesterol and ethical concerns are referred to in the same dimension. taking cholesterol would be considered unethical in the context of a non-work situation. also, a goody-goody woman in the community who claims that coffee addiction is a serious problem and should be banned mentions: i was just wondering if there isn't a moral problem with the taking of caffeine. (p. ). tuan describes harmony's world as follows: plague, booze, and smokes -loot too good to pass up. you could not find any of these things in japan, a nation obsessed with health, or anywhere else under admedistration rule, for that matter. all these vices, things which had gone more or less ignored in the past, had been carved in a list of sins by the all-powerful hand of medicine, and one by one, they had been purged form a society. (p. ). she also mentions: the invention of medicines had put the human body and moral precept side by side on the same lab table… the program took care of the signal sent form the body and transmitted morals in return. the moral code over percent of the people in the world had taken for their own. (p. ). substance intake that leads to poor health is a sin in harmony's world. issues surrounding alcohol, smoking, and coffee suggest that health-related perfectionism is an endless slippery slope. in harmony's world, medicine is the subject of people's faith. in this regard, tuan states: our gods, asklepios and hippocrates, watched closely over us, the 'medicine people' and in their name we built temples to clinical medicine and shock down nearly every disease ever known. our faith was such that we would continue striking them down, and so the medicine people who would never be abandoned by their gods. (p. ). the propensity to avoid caffeine and animal fats, and taking only healthy food, can be considered orthorexia nervosa, an obsession with eating only healthily or an obsessional adherence to a clean, pure, and healthy diet (mccartney ). one commentator argues that individuals with orthorexia consider their eating styles to be virtuous and wholesome, citing ethical reasons for their eating practices, and they may even proudly discuss their dietary practices because they believe their eating behaviors symbolize moral superiority (donini et al. ) . the healthy life is the good life and striving for health is one of the most important goals in life. therefore, a healthy life equates to a good life (komduur et al. ). medical conclaves do their best to help members eliminate health risks. for example, life pattern designers instill in people the notion that they should do as the medical doctor says, i.e., a type of health counseling. life pattern designers determine a lifestyle pattern to optimize both their client's health and their social assessment score by looking at information supplied by watchme (pp. - ). interestingly, emergency rooms in harmony's world are referred to as emergency morality centers (pp. - ). we argue that all aspects of life protection, medical care, and ethics are inseparable, and that healthy longevity equates to goodness in this world. beyond maintaining complete health and extending life to the extent possible, there exists a desire for immortality. in harmony's world, citizens are required to live as resources to the community. tuan explains this as follows: resource awareness. that was how people defined their obligation to society. that and the concept of a communal body. always be aware that you are an irreplaceable resource, they would tell us. (p. ). with the population so dramatically reduced, our bodies are considered public property, valuable resources to society, and as such they were something to be protected, or so went the publicly correct thinking. (p. ). medical conclaves obligate their members to live healthily as long as possible in order to maintain the community. this may be an inevitable consequence of the major disaster which happened half a century ago. but to live for society rather than oneself renders people merely a means to an end-they are objectified. nonetheless, the majority of citizens are willing to fulfill their duty of being healthy and live as long as possible for the sake of their medical conclaves. in harmony's world, one's body no longer belongs to oneself. some people, especially children and adolescents, disagree with this awareness. for example, miach as a high school student wanted a world where one's body was one's own. tuan recalled that this was what miach wanted. miach wanted a body that was hers, not beholden to a society or its rules (p. ). given that citizens are a public existence in harmony's world, individual privacy no longer exists. members of medical conclaves are required not only to keep themselves healthy at all costs, but also to continuously prove their own health to other members of the community. private information such as name, age, occupation, and social assessment score, as well as current health status, must be discussed with other members of society (p. ). in this lifeist society, where it was considered a moral obligation to reveal personal information, especially that concerning one's health, the very word "private" had the illicit stench of secrecy to it. the regional ethics committee ("administration moral consortium") tracks members' assessment scores and discloses them to the public. citizens are constantly evaluated and ranked based on their health. according to tuan: the augmented reality (ar) in my contacts kicks in. ar public metadata: everything in our world had a user review attached to it. even people had little social assessment stars stuck on them. (p. ). it can be argued that a healthy person is a person that you can trust and those who are not healthy seem to be the person who cannot be trusted. however, miach suggests her friends that people are getting tired of this telling-everyone-whothey-are-all-the-time business. what a drag it is to have you to show you are healthy and you are taking care of yourself all the time (p. ). finally, by fully pursuing health and longevity, as well as a medically optimal body, physical diversity is lost in society and the delusion of a "standardized" human body has become reality. the myth of a normalized human body was elevated to a high public standard (p. ). under the constant monitoring of watchme and advice from health consultants, obesity and emaciation were both driven out of the human experience (p. ). all citizens live within the prescribed margins of a healthy adult. regarding this, tuan states: they were all the same. everyone. i realized how bizarre a sight the medically standardized japanese populace presented. (p. ). deviations from standard physique really stood out when everyone was listening so attentively to their health consultant's advice and following their perfectly designed lifestyle plans to the letter. the range of acceptable body types grew narrower every year. (p. ). the atmosphere of conformity that the society generated was too hard to break free of. (p. ). it is clear to us that harmony's world would be intolerant of those who deviate from social standards in any respect. in addition, because of the similarity of harmony's world we would like to refer to, one of the famous english utopian novels, samuel butler's erewhon or over the range. this novel presents a society that values health above all else and punishes citizens who fall sick, blaming them for a moral failing. it seems that erewhon's society is much more unsparing against unhealthy people than harmony world (butler ) . in erewhon, sick people are treated like criminals and they are stigmatized, fined, and imprisoned for a condition they could not help, whereas criminals are treated like sick people and they are helped, attended, and given decent treatments (butler ; osborn ; jenkins ) . in other words, the law of erewhon outlaws physical rather than moral deviations, punishing disease and physical disability while treating acts of dishonesty and theft in the way that we would treat illnesses (parrinder ) . for an example a man in the last stage of tuberculosis being sentenced to life imprisonment. the rationale is that if harsh measures were not taken against disease, a time of universal dephysicalisation would ensue (parrinder ; bulter ). the judge who assumes that the sick are responsible for their acts said to the patient in chronic respiratory failure with severe tuberculosis, "you may say that it is not your fault…if you tell me that you had no hand in your parentage and education and that it is therefore unjust to lay these things to your charge. you may say that it is your misfortune to be criminal; i answer that it is your crime to be unfortunate… infliction of pain upon the weak and sicky was the only means of preventing weakness and sickness from spreading… you are a terrible and perilous character, and stand branded in the eyes of your fellow-countrymen with one of the maximum heinous recognized offences." the underlying rationale for self-responsibility for sickness seems to be based on the erewhonians strange belief that an unborn child in erewhon voluntarily choose to be born according to self-determination, even knowing very bad things could happen in their life. therefore, individuals in the society are completely responsible for their health regardless of its causes or circumstances. many ill individuals attempt to hide their disease in the society (bulter ). in the previous sections, we introduced harmony's world and brought to light various issues pertaining to health worship and the healthy longevity supreme principle, including the strong faith in medicine and healthcare, moralization of health issues, identification of health and good, people's obligation to be healthy, objectification of citizens, loss of privacy and diversity, and one's life designed by others ( table ) . all of these would be problematic from an ethical standpoint. this is because individual freedom would be deprived on many fronts. moreover, harmony's world is value-monistic, perfectionistic, and intolerant of lifestyles that are not perfectly healthy and diverse ways of thinking about healthcare. there are also other issues in this world. below we discuss some of the ethically dubious means and policies that are used in harmony's world to achieve health and longevity. the first means by which harmony's world achieves a perfect healthy utopia is the routinization and automation of healthcare delivery. the combination of watchme, medicare, and medicule have enabled the provision of instant, matter-ofmilliseconds, diagnosis and therapy, as well as prevention. naturally there exists no room for self-determination and the concept of treatment refusal or informed refusal has disappeared completely. every medical intervention has become a matter of course. all medical care procedures are quick and completely routinized. regarding issues with routinization, japanese philosopher kenji hattori rightfully noted that routine examinations are often conducted implicitly without a sufficient explanation or with little expectation that they will be refused, and everyday medical care is being provided with such routine examinations as a matter of course. he also argued that the word "routine" or routinized healthcare system would deprive patients of their initiative in medical decision making by suggesting that all other people or patients would usually do the same thing. he concluded his criticism against routinization by noting that, whenever an action or intervention is intended to be routinized, we should ethically scrutinize potential problems caused by the routinization (hattori ) . in harmony's world, which effortlessly provides citizens with adequate and affordable medical care, the pressure to use it is stronger because no financial barrier exists. in our opinion, there likely is no option not to install watchme, not to set medicare in one's house, or not to receive a diagnosis, prevention, and interventions through medicule in medical conclaves. harmony tells us that the medical conclaves are a gathering of people who have reached a consensus on a particular medical system (p. ), but it is unclear to us the extent to which the consensus is voluntary or what members have actually consented to. the second means by which harmony's world achieves a perfect healthy utopia is through cryptic and clever techniques and covert interventions, including educating individuals to voluntarily internalize social norms, incentives tied to social assessment scores, domination by the atmosphere of society, and kind watching supported by affirmative paternalism. in this world, there is no unilateral and forced order to become healthy-no enforcement exists. rather, people are skillfully driven toward the direction of health promotion. from childhood, they are repeatedly instructed and guided to suppress human instincts and impulsive desires which could result in an unhealthy state through polite education. the world has made them think that they themselves should voluntarily try to be and stay healthy. society requires citizens to voluntarily internalize morality consistent with social norms (p. ). such a framework creates a contradiction within the individual; since it is not simple or high-pressure coercion, face-to-face rebellion and rejection are psychologically difficult. miach notes: i knew how barbaric people could be. and i knew how broken they could become when they tried to repress that nature. i thought that this society, admedistrative society, this lifeist system was all wrong. a society that wanted me to regulate myself internally, even while people were killing themselves all around me. it was just bizarre. (p. ). in our view, if you failed to internalize social norms which are long taught to be self-evidently good and right, you may feel guilty or have reduced self-esteem. you may also feel alienated from others who have naturally accepted these social norms. freedom inside would be lost because you are expected to monitor yourself on your own initiative. to this, miach further notes: a society where rigid self-monitoring was the only path to peace and harmony. (p. ). one commentator states: the everyday practices involved in improving or maintaining our own health -eating, exercising, feeling emotions, managing time, sleep, and so on -do not merely constitute our health; they also constitute our identities. the combination of obligations to internalize and act in accordance with shared moral norms and a focus on individual achievement seems likely to limit human freedoms. (carter et al. ). not only educating people about social norms, but social assessment would also be an incentive to become healthy in harmony's world. careers and medical records are used to award social assessment points. in a world where you must always keep others informed of your health efforts and health condition, the majority of people may want to get as high a score as possible. families and supervisors would also pressure people to do so. there is also psychological control by "the air" or atmosphere, rather than written laws or rules. the atmosphere of harmony's world decides almost everything. invisible rules that reflect common sense and "the air" are conceptually very japanese. regarding impressions about buildings in japanese cities, tuan mentions: there weren't any laws against painting a building something more exciting, and yet here they were, an endless line of houses, all cast in bland, nondescript shades. none of them stood out against others. (p. ). in fact, there are no laws that prohibit drinking in most medical conclaves. one of tian's who colleagues noted: funny thing is, it turns out that out of all the thousands of admedistrations in the world, only twenty-six have laws on the books actually prohibiting alcohol. just twenty-six that forbid their members to imbibe. in all the rest, it's just not done. i am sure that that social assessment analysis has something to do with that. that is how the social assessment points work. as long as enough people agree about something, it starts being reflected in your points, and before you know it, you had better behave or else. and enforcement is built in. (pp. - ). good intentions and kindness make it difficult for people to counter or refute the world's health interventions. harmony's world is not malicious. it is not a cold and cruel surveillance society, but rather a warm and kind watching society. it attempts to connect all people to its server from good will and kindness. importantly, some citizens, like miach's adoptive mother, are thankful. she mentions the following to tuan: my watchme (the public correctness monitoring module in it) just warned me my emotional state was beyond acceptance parameters for interfacing with others. it is a real lifesaver, having another pair of eyes inside me to help me through these things. (p. ). but tuan felt that mankind was trapped in an endless hospital. (p. ). informational regulation as an additional kindness is also notable. it serves as a paternalistic block on harmful information. tuan notes that parts of their history have been censored, images in particular, such as horribly disfigured corpses, and that people need special clearance to see those. even what had probably been considered tame content by the standards of yesteryear was teeming with violence by the peaceful, elegant standards of society (p. ). novels are no exception. tuan indicates that any novel or essay people are about to read would be scanned in advance and cross-referenced with their therapy records (p. ). in the middle of the story, the perpetrator of a massive simultaneous suicide attempt sent a tv station a one-man-one-kill order. the newscaster who read the statement was killed on the air by the mysterious perpetrator. this killing scene was instantly censored by the ai censor. the image cut out and was replaced by other thing (p. ). but how is the ai programmed? perhaps information other than that which protects the individual is also censored, for example, the problems of medical conclaves. information can be fabricated and falsified. delivered contents could be biased in favor of the community. information critical against authorities will probably be cut off. totalitarian control of information is a substantial barrier to autonomous thought and independent decision-making. the third means by which harmony's world achieves a perfect healthy utopia is through inappropriate responses to issues. in harmony's world, there are many suicide attempts and acts of self-harm, particularly among children and young people. yuki keita, an -year-old university professor who does brain research, told tuan that the statistical rise in suicides is troubling and that pharmaceuticals and novel therapeutic treatments, as well as legal support for such treatments, would likely eventually bring these under control. he also noted that those who would want to destroy the safe and stable cycle of life are anathema to the rest of us (pp. - ) . tuan also pointed out that even without the mass simultaneous suicides, administration reports showed an increasing trend in suicide rates among youngsters. more kids were cutting their wrists, hanging themselves, and jumping off buildings (p. ). however, the cause of suicides among youngsters resides exactly in the very system of medical conclaves. in harmony's world, many cannot bear to fit into the molds society stamps for them and, according to tuan, the breakpoint of an over-considerate society is nearing (pp. - ). souls in danger of being crushed by society were, in turn, gnawing away at its underbelly. there are souls that just did not fit, soul of children yearning for disease, for damage, for pain are predominant (p. ). with wickedness in their hearts, they tried to ruin their own precious lives, and they knew what they were doing. tuan thought that something had to be wrong with this picture and even in her brainwashed society people had begun to realize it (pp. - ). a boy who committed suicide said he hated this world and did not belong to the world (p. ). we argue that the high suicide rate in harmony's world is clearly a serious side effect brought about by its social institutions, healthism, super-medicine, and lack of freedom and diversity. one could argue that it is in fact medical conclaves that require emergent intervention and correction, rather than the young wouldbe-suicidal. nevertheless, the leaders of the next-generation human behavior monitoring group carried out the "harmony project" without resolving the true causes. tuan's father, who is a brain scientist, explains the "harmony project" as follows (p. ): in controlling the feedback web in the midbrain with medicules, we found we were able to influence human decisions, emotions, and thoughts. the control of human will was a hot topic with upper leader at who and some of the admedistrations. (p. ). in those days, we picked up a lot of kids like her (miach) and put them into treatment. we gathered the ones that wanted to kill themselves, especially the ones who overate or refuses to eat, the ones who wanted to watch themselves grow weak and die. our goal was to create a harmonized will inside the human brain. we call it the "harmony program." there were plenty of kids back then who had attempted suicide more than once, just as there were plenty of them now. (p. ). because their system of values is fashioned to be in perfect harmony with society, there are far fewer suicides, and the kinds of stress we find in our admedistrative society disappear completely. (p. ). to tuan, it appeared as though her father and his colleagues of the next-generation human behavior monitoring group were trying to create a self-evident person, perfectly adapted to the stresses of the administrative society (p. ). because the correctness of society is self-evident to the leaders, they attempted to alter the values of young people by manipulating their brains. in our view, this is unilateral brainwashing and cannot be ethically justified-the "harmony project" is a typical example of an unethical human experiment. as mentioned above, harmony's world makes it self-evident that health longevity has the highest value and that all members have an ethical obligation to maintain healthy longevity and world peace. the rightness of the object of strong faith would of course be self-evident and an absolute right to believers. those who believe there is self-evident truth would rarely reflect on the justification of the very truth. there is no room for doubt or reflection on the truth. for the sake of respecting self-evident truth, self-evident persons may consider it justified to physically manipulate the brain and alter the consciousness and thoughts of young individuals who cannot accept social norms. we argue that the "harmony program" is a future-world lobotomy. instead of dealing with the real cause that is disturbing and confusing the mind, lobotomy destroys the brains of the mentally ill. before concluding our paper, we present four sf works that are deeply relevant to our discussion of harmony's world, and touch on their contemporary significance in comparison with that of harmony's world. since it is beyond the scope of this paper to introduce in detail the contents of these works, we will mainly focus on backgrounds and events described in each work. these include mental therapy by means of nanotechnology, environmental manipulation, and ultimate harm to japanese society. the first two of the four is a duology, queen of angels ( ) and slant ( ) , written by american sf writer greg bear (bear (bear , . in the world of queen of angels and slant, nanotechnology has been perfected, and humans are given the ability to change their environment and themselves at a cellular level, as well as to achieve perfect mental health. in los angels, the setting of queen of angels, % of people are receiving psychiatric treatment by 'nano therapy,' a literal brain reconstruction in which tiny surgical prochines are used to alter neural pathways. nano therapy is performed to repair genetic defects and improve work, sociality, and human relationships, and to correct the behavior of criminals. in other words, the society has reached a point where effective therapy is a necessity. people are even subjected to permanent mood adjustment. the world depicted in these books is fundamentally different from harmony's world, in that no direct interventions to the mind or brain are generally performed in the latter. nanotechnology is used not only in psychotherapy but also to transform, heal, and strengthen the body. with this technology, police officers can regenerate their severely damaged bodies many times. at the same time, their wounds and diseases are instantly fixed from inside the body using medical monitors and stabilizer infusions. indeed, nanotechnology has realized an 'in-body hospital,' and in this aspect, similarities can be found with harmony's world. murderers are given 'enforced deep therapy,' a therapy that fixes and changes them. personality correction is mandatory for all criminals, resulting in a sharp decline in crime with almost zero murder cases. this therapy is similar to the harmony project in harmony's world. the latter, however, is only used as a last resort for social survival due to its side effects (i.e., deprivation of consciousness). in the world of queen of angels and slant, discrimination and economic disparities emerge between those who receive nano therapy and those who do not. contrarily, harmony's world is free of conflict and disparities. in slant, it becomes apparent that mental therapy based on nanotechnology is ineffective, and difficult-to-treat cases in which individuals repeat anti-social behaviors ("core therapy reject," often with a long criminal history) or experience relapse and worsening of conditions ("fall-out") start to appear. the harmony project in harmony's world would have been implemented to treat suicidal people as planned, had it been successful, and perhaps, its use would have been extended to people with mild mental ailments and mood disorders. if no one followed the one-man-one-kill order in harmony's world, and had the harmony project been successful as mental therapy with no side effects, a peaceful, equal 'slant' might have been realized. as described above, nanotechnology depicted in the duology has been used in the real world for treating various physical illnesses. in the near future, it may be applied to the brain, leading to the establishment of nextgeneration psychiatric surgery. the third story we introduce, from the perspective of quasi-forced environmental manipulation for the purpose of health promotion, is "ai no seikatsu (life of love) (hayashi ) ." it is a part of a collection of short stories on the theme of "creating the future," published by the japanese society for artificial intelligence with the cooperation of science fiction and fantasy writers of japan. the main character is an obese, diabetic male writer. his cohabitating girlfriend left him, as she ran out of patience due to his sloppy and irregular lifestyle. he ended up renting a furnished apartment with home appliances in a brand-new building. however, strange things start to happen in this apartment: in the morning, the curtains open automatically and coffee is made; at pm, room lights automatically turn off. when he tries to have a bowl of rice with curry and pork cutlet for breakfast at a restaurant, his smartphone all of a sudden sends a message, "stop!" he can only buy healthy food with his smartphone payment app. the writer loses weight without even knowing it, and his physical condition improves. he begins to lead a regular life. the story ends with his illness getting better, and his work being a success. as it turns out, a woman had built a self-learning system that combines ai, iot, and ict in order to improve her former roommate's lifestyle habits. this system was manipulating the furniture and household electronics, as well as the writer's smartphone. the main character of this story loses weight and becomes successful and happy. the theme here is how ai embedded in our living environment can change our lives and values without us knowing. it is a world in which people are manipulated into selecting a healthy choice unknowingly. people are constantly monitored, warned if their health condition is poor, and are restricted in terms of access to unhealthy food and products. it is a miniature version of harmony's world, in which the healthier people are, the higher their social assessment score. all is well and good, but we are left with a complex feeling about the clever manipulation, as in the case of harmony's world. the manipulation toward a healthy lifestyle depicted in this story has already begun around the world, as with the above-mentioned japanese health promotion act ( ) (okita, enzo, asai ) . lastly, "ai houkai (ai collapse)" by rintaro hamaguchi depicts the collapse of japanese society, i.e., a crisis of ultimate harm, caused by the malfunctioning of medical ai (hamaguchi ). in , japanese society is completely reliant on a medical ai called nozomi ('hope' in japanese), which has deep learning and self-learning abilities, to carry out medical examination, vital sign monitoring, data management, and physical condition management. roughly % of all japanese medical institutions have introduced nozomi in inpatient practice. patients who visit these institutions send their physical data to nozomi from their wearable devices on a regular basis, and nozomi administers insulin, provides instructions on medication, or controls cardiac pacemakers. moreover, infrastructures related to everyday life such as finance, security, and transportation are also single-handedly managed by this ai. one day, a terrorist hacks nozomi, and nozomi suddenly starts killing patients. the medical ai with the power to decide life and death, now running out of control, brings about a crisis of collapse in japanese society. the terrorist attempts to kill all incompetent people, those who cannot work, and those with low productivity-i.e., the sick, disabled, and elderly-with the aim of rejuvenating japan's super-aged society and creating a society with high economic power and no poverty via the selection of life. this story portrays the horror of ai malfunctioning, and the crisis of ultimate harm brought about by one individual. it would not be strange for something similar to happen in the future. whatever the cause, if watchme's sensor, its network, or medicare which synthesizes medicule falls out of order, a similar crisis would easily fall upon harmony's world. harmony's world aimed to establish a perfect healthy utopia and nearly completely realized this goal. we believe the creation of the world depicted in harmony to be a great work when considered solely from the standpoints of medical science and healthcare. intuitively, the healthier we are and the longer we live, the better. however, from an ethical standpoint, it is clear that there are serious issues with the medical conclave system and unacceptable measures taken to maintain it (table ) . we argue that the existence of harmony's world cannot be accepted as is. we oppose the basic idea of creating a super-healthy society at the expense of all other worthy things, in particular, our freedom, diversity, and privacy. we need to remain a free and diverse existence with the ability to make decisions about one's own life without interference. we do not want to be monitored by a watchful society, even if the intentions are good and ultimately would make us healthier. in harmony's world, even decisions about lifestyle are outsourced. any decision must always be made together with others, and thus it is no longer possible to live according to one's idiosyncratic ways. tuan says, we are expected to always keep personal information on display, to participate in admedistration discussions on morality sessions, and to make decisions only after receiving advice from the appropriate expert. (p. ). she feels that people in administrations prefer that other people decide things for them (p. ). however, in the real world, there are things which we cannot help but decide by ourselves. in harmony, a perfect example of this is the response to the one-man-one-kill declaration. regarding this order, tuan was disgusted with the society that calls for people to gather and talk about the situation. most admedistrations had called immediate sessions to discuss the declaration, but hardly anyone had shown up. what was there to discuss? this was not something you could discuss in public. this was a decision everyone had to make on their own. (p. ). thinking alone and deciding alone is sometimes important, and we should not lose the ability and will to make decisions on our own without support from others, even if it is difficult to do so. we need not be perfect. there is no end to the pursuit of perfection concerning health and longevity in our life because there is no such thing as an objectively "long enough" life-span, and because the occurrence of diseases and disorders is best kept as close to zero as possible. the higher the quality of life, the better. the lower the individual out-of-pocket payments, the better. healthcare is the subject of infinite craving. health needs and desires are virtually limitless beauchamp and childress ) . thus, the pursuit of medical perfection will inevitably end in vain and ruin our satisfaction, acceptance, and peace of mind. social solidarity is important and good, but we argue it is not something we should aim for from the beginning. on the contrary, it is something we achieve naturally and unintentionally as a result of our activities and relations with others. medicine and ethics are different, and health and good are not identical. there is no self-evident truth in our lives. although being healthy is obviously good, health should not be regarded as the only good in our lives. the monistic claim that health has the sole highest value is unacceptable to us pluralists. we consider the infinite craving for health and healthcare problematic, but survival is a more powerful craving by human nature. naturally, some people think they are better off staying alive even in poor health rather than having to face ultimate harm, i.e., the extinction of mankind. however, the validity of this claim depends on the context of poor health. for example, persson & savulescu argued the following in their discussion of ultimate harm: "something could be ultimately harmful by forever extinguishing sentient life, or by damaging its conditions so drastically that, in general, life will not henceforth be worth living (persson and savulescu ) ." therefore, we need to consider what an acceptable condition would be in which we would want to keep living. would people want to live even if in a vegetative state, or as perhaps even a robot or zombie? the answer will be different for each individual. some may not want to keep living if their condition is such that it meets the requirements for euthanasia (e.g., unbearable pain with no prospect to recover), which is practiced in the netherlands and elsewhere. however, others might not feel the same way. with the presence of a loving family, a purpose in life, and valuable memories, some people may wish to live under any physical condition. yet, for those of us who live outside the religious culture of a monotheistic personal god, it is somewhat unrealistic to think that life in any condition is a gift of god and should thus be better lived than lost. we do not understand, frankly, the meaning of "reason for being" in a state of the eternal absence of "self," self-consciousness, and free will, which is realized in the ending of harmony. it can be argued that quality of life studies, by shifting away from ends-oriented criteria such as survival rate and life expectancy and towards subjective psychometrics including our purpose and meaning of life, they propose that a patient's quality of life must be determined in relation to his or her affective preferences and would agree with our position. they translate both the medical condition affecting survival and the affective response to that condition into a common register of temporal progression: qalys. however, the body's physical well-being, i.e. survival or length of life, is taken into account only to the extent that it impacts the patient's affective experience of the time period under consideration (eatough ) . we would argue that our perception concerning our life strongly rely on the purpose and meaning of our lives to provide us with a sense of self-worth and that our sense of self-worth would naturally have a tremendous impact on our subjective estimation of quality of life, which is sometime more important than the length of life. we do not deny the great value of a healthy longevity society. naturally, we do not want to live in a world ridden with disease, disability, pain, premature death, and separation. what is needed is a world where people are adequately healthy, while avoiding harmful health worship and healthism. how can we achieve this? in our view, the answer is provided early on in harmony. the answer is "do everything in moderation." a warrior of the tuareg, one of the characters in the tribe that does not belong to any medical conclave, suggests this. he referred to tuan and her colleagues as "medicine people." below is a conversation between the warrior and tuan. you think we bow too deeply to our gods, then? warrior in a word, yes. 'all things in moderation' you say, but you do not practice it. you are so filled with your faith that you must push it upon us as well. tuan we moderates are in the minority. (pp. - ). finally, in harmony, the top leaders of the next-gen human behavior monitoring group faced a chaotic situation in which murders and suicides among citizens became frequent after the perpetrator's declaration. they were frightened of chaos, frightened of people losing their rational minds, and frightened of riots that would lead to genocide and nukes going off all over the world again. (p. ) as a consequence, they destroyed the consciousness of all members of medical conclaves, including themselves and tuan, in order to conserve the medical conclaves. in a nutshell, harmony tells us a story in which individual consciousness was deprived forever for the sake of preserving the healthy longevity society. to us, the ending suggests that we human beings should not have individual consciousness, self-consciousness, or "i" if we hope to maintain a healthy and peaceful society. we are ambivalent about the story's ending. certainly, if unhealthy foods have disappeared and a medically ideal life plan is presented and exactly followed, then we would be healthier as a group and live longer. those who are self-aware and think freely with different interests and value systems are likely to have conflicts with others and disobey medically appropriate health advice. we are also willing to admit that there are many unhealthy people who are "prematurely dead" from inappropriate lifestyles and addictions to smoking or alcohol. if this is the case, we should not simply dismiss harmony's message as completely nonsensical or fictional. nonetheless, we cannot accept harmony's ending, because a free and autonomous agent must not be used solely for any purpose. harmony's world wrongly defines good, or being ethical, as being healthy in a very monistic way. we argue that it is ethically sufficient for us to live moderately healthily and happily, so long as we remain self-aware, self-conscious, and unique. even if society needs to preserve its values, it is wrong to destroy individual consciousness. a commentator who discusses aldous huxley's two novels argued the danger of forgetting that, in our world, complete control is impossible and that it is even more dangerous to forget why we should be happy that this is so. he added that our world is pluralistic and people hold vastly different views on what a good life entails and that a peaceful pluralism is impossible (schermer ) . in conclusion, we argue that we can lead a reasonably healthy and long life in a peaceful world, so long as everything is done in moderation, we pay some attention to our health, and we are considerate to others in accordance with the no harm principle. however, our self-awareness and consciousness could lead to an unhealthy life and premature death, which otherwise could be preventable. we would rather accept the consequences than lose our free will and self-aware consciousness. another point to note is that the extent to which social control over individuals is considered acceptable changes depending on whether or not the actions of individuals have the potential to harm others. naturally, enhanced social interventions are justified if an act causes direct harm to others, or relates to murder or terrorism. but as argued above, if people have compassion for others and act in accordance with the no harm principle, the potential for ultimate harm could be reduced. our argument is not directed at nuclear weapons or bioterrorism; it is primarily a criticism of excessive health management. just because a certain number of people are unhealthy, it does not mean the whole world would collapse (although healthcare costs would be high). those who follow their own life philosophy and avoid strict health management would have to take responsibility for the consequences of their behavior. healthcare systems could be modified in such a way that, if those individuals get sick due to their own carelessness, they can get treated at their own expense. however, it should be noted that to take a stance that all diseases are to be considered an individual's responsibility overlooks one's upbringing, peer pressure, genetic predisposition, and luck as significant influencing factors. on the other hand, people with highly pathogenic infectious diseases, such as covid- , have the potential to harm others. thus, their isolation is warranted, and the restriction and monitoring of their behaviors as long as they remain infectious cannot be avoided. yet, such requirements must be kept to the necessary minimum, and human rights and social defense must always be balanced. that said, we are not advocating that each person is free to do anythig in any way they desire. we maintain that everything should be done in moderation, and that we should pay attention to our health and be considerate to others in accordance with the no harm principle. we value 'moderation,' which we consider a moral virtue. if many people embodied this virtue, our world would be a better place. we anticipate also that the likelihood of ultimate harm would decrease. according to the analects of confucius, a classic of eastern philosophy, "there is little to choose between overshooting the mark and falling short," and "supreme indeed is the mean as a moral virtue. it has been rare among the common people for quite a long time." these ideas are the basis of the 'everything-in-moderation' principle we advocate (confucius ) . some argue that human beings lack sufficient altruism, empathy for the suffering of others, and a sense of justice, and that it is difficult to cultivate those with conventional methods of education (persson and savulescu ) . unfortunately, we cannot completely deny that assertion. perhaps humans are morally imperfect and our brains cannot stop us from harming others. that said, is it permissible to perform a lobotomy on a person's brain or perform medical interventions aimed at improving morals? or, as in the case of harmony's world, to take away self-consciousness permanently from people? at this time, we cannot agree with these. furthermore, we think that the rights and wrongs of permanently depriving consciousness from people should be determined at least by democratic means, and not by a handful of people. hope for the best and prepare for the worst: ethical concerns related to the introduction of healthcare 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possibilities of ai, health and safety what is genome editing? kodan-sha tokyo the good life: living for health and life without risks? on a prominent script of nutrigenomics harrison's principles of internal medicine th digital pills: a scoping review of the empirical literature and analysis of the ethical aspects clean eating and the cult of healthism a disease as art, heal as a game-reading harmony a decade later reexamination of the concept of 'health promotion' through a critique of the japanese health promotion policy samuel butler's erewhon as social psychology entering dystopia, entering "erewhon unfit for the future: the need for moral enhancement brave new world versus island -utopian and dystopian views on psychopharmacology. medicine, health care and philosophy the economist what nanobasics should be taught in medical school? the future of the professions: how technology will transform the work of human experts publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgements our paper has been writing under the support of human information technology ecosystem (hite). hite is a research and development (r&d) focus area delivered by the research institute of science and technology for society (ristex), japan science and technology agency (jst). conflict of interest the authors declare that they have no conflict of interest. key: cord- - bo s hz authors: lezotre, pierre-louis title: part i state of play and review of major cooperation initiatives date: - - journal: international cooperation, convergence and harmonization of pharmaceutical regulations doi: . /b - - - - . - sha: doc_id: cord_uid: bo s hz abstract the basic principle of international cooperation is to establish bilateral and multilateral efforts to leverage the human, scientific and financial resources and the knowledge and experience of other key regulatory authorities to avoid duplication of efforts, to make activities more efficient and to allow the focussing of limited resources on higher-risk areas of concern. this increased cooperation between worldwide regulators has necessitated proactive deliberate efforts towards convergence/harmonisation of regulation, practices and requirements to eliminate or reduce differences. cooperation and harmonisation of standards in the pharmaceutical domain are already a reality and have become increasingly important during recent decades, with a high level of commitment to these activities by all stakeholders. the worldwide drug regulatory authorities (dras) have been working to end an isolationist attitude that cannot resolve current worldwide issues and challenges caused by an ever increasing globalisation. as a result, many cooperation and harmonisation initiatives have been established at the bilateral, regional and global levels as a response to the changing geo-economic-political situation. the spectrum of collaboration varies from simple informal technical cooperation to full integration of systems and regulations. indeed, all these initiatives can be very different in scope (some are part of a broader harmonisation initiative), level of harmonisation (depending on the political support/commitment), organisation (well-structured versus simple discussion) or advancement (established process vs. pilot projects), but they all work towards convergence of requirements and/or practices. all these multiple worldwide cooperation and harmonisation programmes have evolved rapidly over the past decades. this book section provides the current status of this complex and broad phenomenon of cooperation, convergence and harmonisation in the pharmaceutical sector. it reviews all major global, regional and bilateral cooperation initiatives. many aspects of increased globalization also have profound implications on pharmaceutical regulation worldwide. in general, globalization of the economy (with increased travel of people and exchange of goods, finance, and information), and also globalization of the pharmaceutical market (including development, manufacture, and distribution activities), requires increased cooperation and harmonization of pharmaceutical standards and regulation. pharmaceutical industries have asked for better harmonization of requirements for the development and manufacture of pharmaceutical products to avoid duplication of work that ultimately creates delays in drug availability [ ] . in this context, harmonization of pharmaceutical regulations has naturally become an important topic of discussion among worldwide drug regulatory authorities (dras). over the past several decades, they have been working to end an isolationist attitude that cannot resolve current worldwide issues and challenges. as a result, many cooperative initiatives (bilateral, regional, and global) were established, and harmonization efforts have been enhanced. all these initiatives can be very different in scope (some are part of a broader harmonization initiative), level of harmonization (depending on the political support/commitment), organization (well structured versus simple discussion), or advancement (established process versus pilot projects), but they all work towards harmonization of requirements and/or practices. increased exchange of information on a regular basis (e.g., more than countries and international organizations from australia to vietnam now have agreements to share information with the united states food and drug administration [us fda]) [ ] also contributes to the natural convergence of requirements and practices. harmonization models can be distinguished by their scope and objectives. indeed, the spectrum of collaborations varies from simple technical cooperation to full integration of systems and regulations: ▸ integration model: in this type of agreement, most of the time driven by political decision, deeper harmonization of regulation is achieved with the creation of supranational central authorities in order to support integration and/or creation of a single market (e.g., eu, the association of southeast asian nations [asean] ). in this case, harmonization of standards and regulations is critical in reducing trade barriers. in this model, countries give up some of their autonomy on certain matters by transferring the power to make decisions to the common supranational authority or by automatically recognizing decisions from the other party (via mutual agreement mechanisms). the african medicines registration harmonization (amrh) initiative has defined five identifiable levels of harmonization ( figure ). to facilitate cooperation, a mutual recognition agreement (or arrangement) (mra) can be signed by one or more parties to mutually recognize or accept some or all aspects of one another's requirements. they can be concluded at the technical level (e.g., the status and future plans," november . confidentiality arrangements between the us fda and european medicines agency [ema] , or the mra between eu and australia) or at the government level (e.g., european treaty). these multilateral initiatives are major projects as they involve multiple organizations and countries and represent the highest degree of harmonization. the objective of this technical and scientific intergovernmental cooperation is to globally discuss scientific issues that support the decisions made by individual governments and international regulatory bodies in order to achieve global scientific consensus. the goal is to facilitate the development of new medicines and to make them available to the maximum number of people worldwide. there is no intent of full integration of systems and regulations. the main difficulty faced by these initiatives is the complexity and management of the structure due to the important number of participants (e.g., the world health organization [who] has member states) and the diversity of needs, challenges, and level of development of its members. the world health organization (who) was established in as a specialized agency of the united nations (un) [ ] . it is accountable to its member states and works closely with other entities of the un system. this agency has a very broad scope of responsibilities as it is the directing and coordinating authority for international health matters and public health within the un system. who is well known for some of its work (e.g., the coordination of influenza surveillance and monitoring activities, emergency assistance to people affected by disasters, mass immunization campaigns or actions against human immunodeficiency virus/acquired immunodeficiency syndrome [hiv/aids], tuberculosis, and malaria). however, who undertakes many more activities because it is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. most of these core functions, as further defined in its " th general programme of work," [ ] rely on cooperation and harmonization of standards. this focus on regional and global collaboration, and especially aid from developed countries to developing countries, is aligned with the un millennium development goals (mdgs). a a the united nations millennium development goals (mdgs) are eight international goals that un member states (and international organizations) have agreed to achieve by the year . they are derived from the united nations millennium declaration, signed in september , which endorsed a framework for development and commits world leaders to combat poverty, hunger, disease, illiteracy, environmental degradation, and discrimination against women. these mdgs are interdependent and several relate either directly or indirectly to health. who is therefore very involved in this process and works with countries to achieve the health-related mdgs. indeed, the objective of these mdgs is that countries and development partners work together to improve the global situation and resolve major issues. a number of specific targets and indicators have been identified to monitor progress towards the goals. goal ("develop a global partnership for development") specifically recognizes the role of developed nations and addresses global cooperation and partnerships. who has worked in the area of pharmaceuticals since its creation approximately years ago. during this time, many products and services have been created that are widely recognized as core functions of who. the role of who in pharmaceutical regulations is based on its constitutional mandate and various world health assembly (wha) resolutions. this support is twofold. one aspect relates to the development of internationally recognized norms, standards, and guidelines. the second relates to providing guidance, technical assistance, and training in order to enable countries to implement global guidelines to meet their specific medicines regulatory environment and needs [ ] . all countries that are members of the un may become members of who by accepting its constitution. other countries may be admitted as members when their application has been approved by a simple majority vote of the world health assembly (wha). territories that are not responsible for the conduct of their international relations may be admitted as associate members upon application made on their behalf by the member or other authority responsible for their international relations. members of who are grouped according to regional distribution. who's strength lies in its neutral status and nearly universal membership. today, it represents countries and two associate members (puerto rico and tokelau). one country is an observer (vatican) [ , ] . the organization is headed by the director-general, b but the wha is the supreme decisionmaking body for who. it generally meets in geneva, switzerland in may of each year, and is attended by delegations from all member states. its main function is to determine the policies of the organization. the health assembly also appoints the director-general (on the nomination of the executive board), supervises the financial policies of the organization, and reviews and approves the proposed budget. the work of the assembly is supported by the executive board, which it elects. this executive arm of the assembly is composed of members technically qualified in the health field. members are elected for three-year terms. the main board meeting, at which the agenda for the forthcoming health assembly is agreed upon and resolutions for forwarding to the health assembly are adopted, is held in january. a second shorter meeting in may, immediately after the health assembly, is held to address more administrative matters. the primary functions of the board are to give effect to the decisions and policies of the health assembly, to advise it, and generally to facilitate its work. under the leadership of the director-general, c more than , people from more than countries work for who. this who staff includes health professionals (including medical doctors, public health specialists, epidemiologists, and scientists) as well as managers, economists, administrators, and other professionals. they are located in country offices, six regional offices, and at the headquarters in geneva, switzerland [ ] . one of the unique aspects of who is its decentralized structure. who's work is a great combination of actions at the country, regional, and global levels. these efforts to decentralize its structure are aimed at getting closer to the ground (field) where decisions made can be more responsive to actual needs. indeed, this decentralized and regionalized structure provides who with multiple opportunities for engaging with countries. who's global headquarters is located in geneva, switzerland. the team based at the global headquarters supports and builds on all of the regional and local efforts. it sets global policies and standards, facilitates technical support to regions and countries, monitors and publicizes progress, and helps mobilize political and financial support. at the who headquarters, medicine activities are conducted within the cluster of health systems and services (hss) and are coordinated by the department of essential medicines and health products (emp). this department (which employs about staff members [ ] ) is involved in the harmonization of pharmaceutical regulations because it coordinates various activities in the areas of quality assurance (e.g., the international pharmacopoeia, international nonproprietary names [inn] , prequalification of medicines, counterfeit medicines), regulation and legislation (e.g., international conference of drug regulatory authorities [icdras]), and safety and efficacy (e.g., drug alerts). these activities comprise guideline development, workshops, and training courses, coordination and promotion of pharmacovigilance for global medicine safety, regulatory and other information exchange, and review of narcotic and psychotropic substances. who member states are grouped into six regions, each of them having a regional office: ▸ who regional office for africa in brazzaville, republic of congo. ▸ who regional office for europe in copenhagen, denmark. ▸ who regional office for southeast asia in new delhi, india. ▸ who regional office for the americas/pan american health organization (paho) in washington dc, united states. ▸ who regional office for the eastern mediterranean in cairo, egypt. ▸ who regional office for the western pacific in manila, the philippines. each of who's regional offices are the first point of contact for country offices that need extra technical or financial help. these regional offices also give special attention to adapting global policies to fit specific needs in their regions. indeed, the regional level is important in the who organization as it links the global strategy and plan with the country's reality and needs. they play a key role in the implementation of who norms and standards by ensuring that: ▸ country and regional needs are taken into consideration when who norms and standards are developed ▸ global guidelines and internationally recognized norms and standards are appropriately implemented in their regions (in the context of their own specific regulatory environment and challenges) by providing guidance, technical assistance, and training in addition to global activities coordinated from who headquarters, who regional and country offices can also carry out a variety of medicine-related activities specific to their regions. in addition to the regional and headquarters offices, who has country offices that cover member states. d there are also two field offices (the who humanitarian assistance office in pristina, kosovo and the west bank and gaza office) and offices covering two different areas, the us-mexican border field office in el paso, texas (us), and the office of caribbean program coordination in barbados. who has also established "who liaison offices" in key locations (e.g., at the european union in brussels, belgium, at the african union and the economic commission for africa in addis ababa, ethiopia, in washington dc, us, and at the un in new york city) and more than "technical offices" (e.g., the european observatory on health systems and policies in berlin, germany) [ ] . d some countries that do not have a physical who country office are served by the who representative of another country (for instance, the who representative to malaysia covers not just malaysia, but also brunei, darussalam, and singapore) . approximately % of who country offices are either owned or supported by the government and ministries of health. some of these who country offices are located in independent premises either rented or owned by who, while others are located within ministries of health or un common premises. these country offices are led by the head of who office (hwo), who are designated by the director-general and by the respective regional directors. the hwo manages who core functions at the country level and provides leadership in the following key functional areas: ▸ advocacy, partnership, and representation ▸ support for policy development and technical cooperation ▸ administration and management it is important to note that who is focused on needs of countries and emphasizes in particular the decentralization process that is aimed at increasing who's impact on health and development at the country level. this country focus tailors who's technical collaboration to the needs and capacities of each member state, with a special emphasis on the poorest countries and most fragile contexts. the key principles guiding who cooperation in countries are [ ] : ▸ ownership of the development process and projects by the country ▸ alignment with national priorities and strengthening national systems ▸ harmonization with the work of sister un agencies and other partners in the country towards better aid effectiveness ▸ collaboration as a two-way process that fosters member states' contributions to the global health agenda who's country presence is the platform for effective cooperation with countries for advancing the global agenda, contributing to national health strategies and planning, and bringing country realities and perspectives into global policies and priorities. according to the above principles and its structure, who is indeed able to focus on countries' needs and better define its priorities to actively support the development, implementation, monitoring, and assessment of national health policies, strategies, and plans. but it also allows for better monitoring implementation of global agreements such as the millennium development goals (mdgs) and the international health regulations (ihr [ ] ). these activities in countries are governed by the country cooperation strategy (ccs), which is who's key instrument to guide its work in countries. it is a medium-term vision (generally covering four to six years) for its technical cooperation with a given member state, in support of the country's national health policy, strategy, or plan. it is an organization-wide reference that guides partnership, planning, budgeting, and resource allocation. who also established the department of country focus (cco) to support and advocate for who country offices, develop the capacity of who country teams for effective engagement in partnership platforms, and facilitate and monitor who's engagement in the aid effectiveness agenda at the country level. for example, cco provides support for the development, dissemination, and use of the country cooperation strategy. ▸ expert committees: expert committees have an important role in who activities. they are defined in the who constitution. e in addition to the constitution, regulations for expert advisory panels and committees are also included in the who document entitled "regulations for expert advisory panels and committees." f an expert committee is the highest official advisory body to the director-general of who as well as to all the organization's member states. it is established by the wha or by an executive board decision. there are various types of who expert committees. for example, the who expert committee on specifications for pharmaceutical preparations (ecspp) has been providing, for more than years, recommendations and tools to assure the quality of medicines from their development phase to their final distribution to patients. there is also the expert committee on biological standardization (ecbs), which is as old as the ecspp. in addition to its structured organization, the who has been supported since its creation by its "collaborating centers." these are institutions such as research institutes and parts of universities or academies that are designated by the director-general to carry out activities in support of who programs. currently there are over who collaborating centers in over member states working with who in several areas (one of them being "pharmaceuticals"). several collaborating centers may exist for the same topic (e.g., international classifications or traditional medicines) and form a specific network to help who regarding this specific topic. of causes of death. who also started to publish its bulletin, which is today an international peer-reviewed monthly journal of public health with a special focus on developing countries. j in its early years, who's priority was the prevention and control of specific diseases (e.g., malaria, tuberculosis, smallpox, yaws, onchocerciasis, and venereal disease), some of which are still a problem today. they also focused on women's and children's health and nutrition, and environmental sanitation. who's work has since grown to cover other (sometimes new) health problems (including polio, hiv/aids, and severe acute respiratory syndrome [sars] ), but it also works to control tobacco and alcohol use and to promote diet and physical activity to prevent the four main noncommunicable diseases (cardiovascular disease, cancer, chronic lung diseases, and diabetes) [ ] . who has also been increasingly involved in the global regulation and control of medicines. in , the first essential medicines list was released two years after the wha introduced the concepts of "essential drugs" and "national drug policy." one hundred and fifty-six countries today have a national list of essential medicines. who has also funded many projects over the years to facilitate global cooperation and harmonization of standards. the purpose of all these activities in the pharmaceutical domain is aimed at increasing global and equitable access to safe, effective medicines of assured quality. this specific goal is derived from the overall objective of who to improve and maintain global public health. this objective has been regularly reiterated in several wha resolutions and during other events such as the icdras. in , the international conference on primary health care (alma-ata, kazakhstan) set the historic goal of "health for all," to which who continues to aspire. more recently, the un mdgs have further clarified the objectives and priorities of global cooperation derived from the un millennium declaration signed in september . one of who's mandates is "to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products" [ ] . who member states (especially developing countries) rely on who for expertise and guidance in regulation, safety, and quality assurance of medicines through development and promotion of international norms, standards, guidelines, and nomenclature. to achieve this goal, who relies on cooperation and uses its decentralized organization to facilitate implementation of projects and agreed-upon standards. the harmonization activities are initiated according to the who's medicines strategy. trigger actions to initiate a new project or development of a standard are given at different levels and bodies (i.e., the wha, executive board resolutions, icdras, or who programs and j since it was first published in , the bulletin has become one of the world's leading public health journals. as the flagship periodical of who, the bulletin draws on both who experts (as editorial advisors, reviewers, and authors) and external collaborators. clusters). these projects and standards are then developed through a vast global consultation process involving who member states, national and regional authorities, international agencies, and with specialists from industry, national institutions, nongovernmental organizations, etc. project updates and approved standards become publically available through the extensive list of who publications to support national, regional, and global health strategies. k because the global dissemination and exchange of information is important, who secures the broad international distribution of its publications and encourages their translation. l this ensures the widest possible availability of authoritative information and guidance on health matters. the department of emp, based at the who global headquarters in geneva, works closely with expert committees, other regulators, and relevant who collaborating centers to develop and implement these harmonization activities. this department coordinates these activities globally with the support of who's regional advisors and country project staff in each of the regional offices and many country offices. each of the regional offices has two to five professionals coordinating the medicines strategy, and who country offices have full-time pharmaceutical policy experts [ ] . it is worth mentioning that in addition to its normative activities and harmonization projects, who also assists countries in capacity building by assessing regulatory systems. it does this by facilitating cooperation and information exchange between countries and by providing technical support. it is very important to involve all countries (whatever their development level), and to facilitate the implementation of norms and standards. finally, who has developed relationships with a lot of nongovernmental and civil society organizations on a global basis via the civil society initiative (csi) , and also at regional and national levels. the objectives of who's relations with nongovernmental organizations (ngos) are to promote the policies, strategies, and activities of who to facilitate their implementation. who has a large repertoire of global normative work relevant for all levels of development. in the area of medicines, a lot of standards, norms, and classifications have been developed, and forums/networks have been created to enhance global cooperation. important initiatives are presented below. k who publishes practical manuals, handbooks, and training material; internationally applicable guidelines and standards; reviews and analyses of health policies, programs, and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision makers. also, the who technical report series makes available the findings of various international groups of experts that provide who with the latest scientific and technical advice on a broad range of medical and public health subjects. l in , the world health assembly turned multilingualism into a who policy by establishing six official languages (arabic, chinese, english, french, russian, and spanish) . since the adoption of a resolution, all governing bodies' documents and corporate materials have been made available online in all official languages. the international conference of drug regulatory authorities (icdras) provides drug regulatory authorities of who member states with a forum to meet and discuss ways to strengthen collaboration and harmonization of pharmaceutical regulations. this is a key accomplishment of who that has been instrumental in guiding dras, who, and interested stakeholders to develop national, regional, and international medicines regulation, and it continues to be a cornerstone of international harmonization of medicines regulation. these conferences have been held since , and they have involved both developed and developing countries. the th icdras, held in singapore from november to december , , involved participants from over agencies. the th icdras, which took place in tallinn, estonia from october to , , was attended by over participants from countries. the aim of these conferences is to promote the exchange of information and collaborative approaches to issues of common concern. topics discussed include quality issues, herbal medicines, homeopathy, regulatory reform, medicine safety, counterfeiting, regulation of clinical trials, harmonization, new technologies, and e-commerce. recommendations are proposed for actions to take among agencies, who, and related institutions. it is worth mentioning that the idea to create ich began to formulate after background discussions between the us, the european union (eu), and japan during the th icdras conference in paris, france in [ ] . as a platform was established to develop international consensus, the icdras continues to be an important tool for who and dras in their efforts to harmonize regulation and improve the safety, efficacy, and quality of medicines on a worldwide basis. the who constitution mandates the production of international classifications on health. these internationally endorsed classifications, developed through the who network m are very important as they facilitate the storage, retrieval, analysis, interpretation, and comparison of data. they support global cooperation and harmonization by providing a consensual framework that governments, healthcare providers, and consumers can use as a common language. they also permit the comparison of data not only within populations over time, but also between populations. who reference classifications are the international classification of diseases (icd), the international classification of functioning, disability and health (icf), and the international classification of health interventions (ichi). in addition, related and derived classifications (based on the reference classifications) have also been developed (e.g., the anatomical therapeutic chemical classification with defined daily doses (atc/ddd) that classifies m who has designated a number of collaborating centers to work with it in the development, dissemination, maintenance, and use of the who international classifications. therapeutic drugs according to the organ/system on which they act, and their chemical, pharmacological, and therapeutic properties). the who international clinical trials registry platform (ictrp) is a global initiative that aims to make information about all worldwide clinical trials involving humans publicly available. this activity was launched during the th wha in n following discussions and recommendations from a ministerial summit on health research in mexico city, mexico in november . the ictrp is not itself a clinical trials registry, but a central repository that can be searched using the who search portal (http://apps.who.int/trialsearch/). all items in the trials registration data set are copied from individual registries onto the who central repository, and data is updated regularly. indeed, details on clinical trials come directly from one of the primary registries o in the who registry network (e.g., the european clinical trials register that became a member of the network in september p ). by consolidating clinical trials information from several worldwide sources using standardized data set format/criteria, and by implementing unambiguous identification (i.e., a universal trial number [utn] ), the ictrp not only facilitates the exchange of information, but also promotes harmonization of this information. harmonization is also further achieved because who proactively supports countries/regions in establishing who-compliant clinical trials registries or policies on trial registration. quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. this is a major public health challenge, particularly in light of growing cross-border health issues and the growing international dimensions of trade. the quality of pharmaceuticals has been a concern of who since its inception. the development of norms, standards, and guidelines to promote quality assurance is an integral part of who's constitution, and has been endorsed and supported through numerous wha resolutions. more recently, the who medium-term strategic plan for - requested that the organization develop international standards, recommendations, and instruments to assure the quality of medicines, whether produced and traded nationally or internationally. n resolution wha . called on the global scientific community, international partners, the private sector, civil society, and other relevant stakeholders to "establish a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others." o a primary registry in the who registry network is a clinical trial registry with at least a national remit that meets who registry criteria for content, quality and validity, accessibility, unique identification, technical capacity, and governance and administration. p the european clinical trials register provides public access to information extracted from the eu clinical trial database ("eudract"). the who medicines quality assurance program, which is part of the emp department, produces norms, standards, and guidelines on the quality assurance of pharmaceuticals. these regulatory tools are prepared through a vast global consultative process, and are ultimately approved by the who ecspp, q which meets annually. the report of each meeting (technical report series) includes newly adopted guidelines in its annexes. when adopted, the norms, standards, and guidelines become international harmonized standards intended for use by national dras, manufacturers, and other interested parties. many important international standards and projects have been developed in this area: ▸ good manufacturing practice (gmp) ▸ guidelines for regulatory approval (e.g., the guidelines on stability testing or on registration requirements to establish the interchangeability of multisource generic pharmaceutical products and the proposal to waive in vivo bioequivalence requirements) ▸ prequalification of medicines, laboratories, and supply agencies ▸ model certificates for quality assurance-related activities ▸ quality control testing ▸ new specifications for inclusion in the basic tests series and the international pharmacopoeia ▸ international chemical reference substances (icrs) r ▸ the inn program some of these international guidelines and projects are further developed below. ▸ good manufacturing practice: good manufacturing practice (gmp) is the part of quality assurance that ensures products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. gmp is aimed primarily at diminishing the risks involved in any pharmaceutical production that cannot be eliminated through testing of the final product. s gmp covers all aspects of production: from the starting materials, premises, and equipment, to the training and personal hygiene of staff. detailed, written procedures are essential for each process that could affect the quality of the finished product. panel on the international pharmacopoeia and pharmaceutical preparations. r icrs are used by laboratories to test pharmaceuticals for the purpose of quality control. these substances are mainly used for validating the results from specific tests, and as primary standards for calibrating secondary standards. who's collection of icrs is now maintained by the council of europe's european directorate for quality of medicines and healthcare (edqm) , which also distributes the substances worldwide. edqm is responsible for obtaining candidate material, testing it to ensure its purity and suitability, and reporting results with recommendations to who. s the main risks are the following: unexpected contamination of products causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; and insufficient or too much active ingredient resulting in ineffective treatment or adverse effects. recognizing the importance of gmp in international commerce of pharmaceutical products, who developed requirements early on. the first who draft text on gmp was prepared in by a group of consultants at the request of the th wha [ ] . it was subsequently submitted to the st wha under the title "draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialties" and was accepted. in , the revised text was discussed by the who ecspp and published as an annex to its nd report. the text was then reproduced, with some revisions, in in the supplement to the nd edition of the international pharmacopoeia (ph. int.). since then, who has further defined its general principles and requirements regarding gmp [ ] , and it has also established several detailed guidelines covering specific needs for gmp of active pharmaceutical ingredients [ ] , pharmaceutical excipients [ ] , sterile pharmaceutical products [ ] , biological products [ ] , blood establishments [ ] , pharmaceutical products containing hazardous substances [ ] , investigational pharmaceutical products for clinical trials in humans [ ] , herbal medicinal products [ ] , radiopharmaceutical products [ ] , and water for pharmaceutical use [ ] . finally, it also developed guidelines of a more general scope such as validation [ ] , risk analysis [ ] , technology transfer [ ] , and inspection [ ] , and has created appropriate training materials for countries. many countries have formulated their own requirements for gmp based on the who gmp. the international pharmacopoeia (ph. int.) comprises a collection of quality specifications for pharmaceutical substances (i.e., active ingredients and excipients) and dosage forms together with supporting general methods of analysis. it is intended to serve as source material for reference or adaptation by any who member state. clearly defined steps are followed in the development of new monographs. the ph. int. is published by who with the goal of achieving a wide global harmonization of quality specifications for selected pharmaceutical products, excipients, and dosage forms. the ph. int., or any part of it, has legal status whenever a national or regional authority expressly introduces it into appropriate legislation. the history of the ph. int. dates back to when the need to standardize terminology and to specify dosages and composition of drugs led to attempts to produce an international pharmacopoeia compendium. the first conference, called by the belgian government and held in brussels in , resulted in an agreement for the unification of the formulae of potent drugs, which was ratified in by countries. the outcome considerably influenced the subsequent publication of national pharmacopoeias. in , the interim commission of the who took over the work on pharmacopoeias previously undertaken by the health organization of the league of nations. the rd wha, held in may , formally approved the publication of the "pharmacopoea internationalis" and recommended, in accordance with article of the who constitution, "the eventual inclusion of its provisions by the authorities responsible for the pharmacopoeias." it was thus recommended that the "pharmacopoea internationalis" not be used as a legal pharmacopoeia in any country unless adopted by the pharmacopoeial authority of that country. this first edition, published with the aim of creating a worldwide, unified pharmacopoeia, relied on collaboration with national pharmacopoeia commissions for its preparation. in , the purpose of the ph. int. was reconsidered. it was decided that the publication should focus more on the needs of developing countries (because developed countries had established their own pharmacopoeias), and recommended only simple, classical chemical techniques that had been shown to be sound. since , the drugs appearing in the ph. int. have therefore been selected from the list of essential drugs based on the first report of the who expert committee on the selection of essential drugs. also, whenever possible, classical procedures are used in the analytical methods so that the use of expensive equipment is minimized in the application of the ph. int. to facilitate its implementation by developing countries. the work on the ph. int. is carried out by the who ecspp in collaboration with members of the who expert advisory panel on the international pharmacopoeia and pharmaceutical preparations and other specialists [ ] . the process involves consultation with, and input from, who member states and dras, who collaborating centers and national drug quality control laboratories in all six who regions, standard-setting organizations and parties including regional and national pharmacopoeias, and manufacturers around the world. in , the wha adopted a resolution [ ] to create the international nonproprietary names (inn) program in order to identify pharmaceutical substances unambiguously on a worldwide basis, and to provide a universal, unique, nonproprietary name to be used in pharmacopoeia monographs. it began operating in when the first list of inns for pharmaceutical substances was published. today, this program is coordinated by the who emp department. the selection of a new inn relies on a strict procedure [ , ] . this process is supported by the expert advisory panel on the international pharmacopoeia and pharmaceutical preparations, which provides advice on proposed names following an application made by the manufacturer or inventor. the procedure also involves the who secretariat, which examines the suggested names for conformity with the general rules, similarities with published inns, and potential conflicts with existing names. after a time period for objections has lapsed, the name will obtain the status of a recommended inn and will be published as such in "who drug information" if no objection has been raised. to make inns universally available, they are formally placed by who in the public domain, hence their designation as "nonproprietary" names (also known as "generic names"). the existence of this international nomenclature for pharmaceutical substances is important for the clear identification, safe prescription, and dispensing of medicines to patients, but also for communication and exchange of information among health professionals and scientists and regulators worldwide. it provides them with a unique and universally available designated name to identify each pharmaceutical substance. today, inn names are widely used and globally recognized. at present, more than , inns have been published, and this number is growing every year. the majority of pharmaceutical substances used in medical practice are designated by an inn, and their use is already common in research and clinical documentation. nonproprietary names are intended for use in pharmacopoeias, labeling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names (e.g., for generics). also inn collaborates closely with numerous national drug nomenclature bodies. the use of inn names is normally required by national authorities and also by the european community. as a result of ongoing collaboration, national names such as british approved names (ban), dénominations communes françaises (dcf), japanese adopted names (jan), and united states adopted names (usan) are nowadays, with rare exceptions, identical to the inn. in addition to the quality standards, who also developed norms and standards for pharmacovigilance, and promotes information exchange on medicine safety. the aim is to assure the safety of medicines by ensuring reliable and timely exchange of information on drug safety issues, promoting pharmacovigilance activities on an international basis, and encouraging participation in the who program for international drug monitoring [ ]. in , who established its program for international drug monitoring in response to the thalidomide disaster in . at the end of , countries were part of the who pharmacovigilance program. an international system for monitoring adverse drug reactions (adrs) using information derived from member states was established in . this allows who to issue a rapid drug alert whenever a serious problem in the safety of any medicinal product arises. who headquarters in geneva is responsible for policy issues, while the operational responsibility for the program rests with the who collaborating centre for international drug monitoring, uppsala monitoring centre in sweden. a common reporting form was developed, agreedupon guidelines for entering information were formulated, common terminologies and classifications were prepared, and compatible systems for transmitting, storing and retrieving, and disseminating data were created. the adrs database in uppsala currently contains over three million reports of suspected adrs. in , a who advisory committee on safety of medicinal products (acsomp) was established to guide who on general and specific issues related to pharmacovigilance. additionally, a network of "information officers" was established in to allow a direct relationship between who and all national dras in member states. each national information officer is charged with providing information to who on the safety and efficacy of pharmaceutical preparations, and with securing prompt transmission to national health authorities regarding new information on serious adverse effects. this certification scheme was initially adopted by the nd wha in [ ], but since then it has been amended. it is an administrative instrument that requires each participating member state, upon application by a commercially interested party, to attest to the competent authority of another participating member state whereby: ▸ a specific product is authorized for placement on the market within its jurisdiction, or if it is not authorized, the reason why that authorization has not been accorded. ▸ the manufacturing plant in which it is produced is subject to inspections at suitable intervals to establish that the manufacturer conforms to gmp as recommended by who. ▸ all submitted product information, including labeling, is currently authorized in the certifying country. the primary document delivered under this scheme is the certificate of pharmaceutical product (cpp), but two other documents can be requested within the scope of the scheme. the first is a statement of licensing status of pharmaceutical product(s), and the second is a batch certificate of a pharmaceutical product (this document is rarely applied other than to vaccines, sera, and biologicals). these documents are used by dras of importing countries in their decision to approve, renew, extend, or vary a license. who created models for these confidential documents and listed the information that such certificates need to include. obligations that certifying authorities need to fulfill in order to be able to deliver a certificate have also been defined [ ]: ▸ possess an effective national licensing system, not only for pharmaceutical products, but also for responsible manufacturers and distributors. ▸ have gmp requirements, in agreement with those recommended by who, to which all manufacturers of finished pharmaceutical products are required to conform. ▸ effective controls must be in place to monitor the quality of pharmaceutical products registered or manufactured within its country, including access to an independent quality control laboratory. ▸ have a national pharmaceuticals inspectorate, operating as an arm of the national dra, and having the technical competence, experience, and resources to assess whether gmp and other controls are being effectively implemented, and the legal power to conduct appropriate investigations to ensure that manufacturers conform to these requirements by, for example, examining premises and records and taking samples. ▸ support administrative capacity to issue the required certificates, to institute inquiries in the case of complaint, and to notify expeditiously both who and the competent authority in any member state known to have imported a specific product that is subsequently associated with a potentially serious quality defect or other hazard. gmp standards provide the basis for the who certification scheme that relies on the capacity, experience, and expertise of the certifying authority of the exporting country. this scheme is a great example of cooperation between countries and is an important tool to support a regulatory system in developing countries that do not have enough capacity, resources, or expertise. biological medicinal products, such as vaccines, blood and blood products, diagnostics, gene therapy, biotechnology products, cytokines and growth factors, and cell and tissue products, rely heavily on international standardization to ensure their quality and their equivalence across manufacturers. this is especially true due to the increasing globalization in the production and distribution of these biological medicines. over the past years, who has worked to standardize these biological materials by establishing international biological reference materials t as well as developing international guidelines and recommendations on the production and control of biological products and technologies. guidelines provide more general information on a range of topics of interest to national dras and manufacturers (e.g., "guidelines on evaluation of similar biotherapeutic products, sbps"), whereas recommendations establish the technical specifications for manufacturing and quality control of specific products (e.g., "recommendations to assure the quality, safety and efficacy of bcg vaccines"). who has also released many other documents on general topics (such as "regulation and licensing of biological products in countries with newly developing regulatory authorities" [ ] and "good manufacturing practices for biological products" [ ]) or on a specific type of product (e.g., blood products and related biologicals, cells and tissues, cytokines, or vaccines) to facilitate control of these biological products on a worldwide basis. these norms and standards have been developed to assist who member states in ensuring the quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide. by adopting these guidance documents in their pharmacopoeias or equivalent legislation, each country ensures that the products produced and used in their country conform to current international standards. by advising national dras and manufacturers on the control of biological products, regulatory guidance documents also establish a harmonized regulatory framework for products in international markets. who accomplishes its biological program through the who collaborating centers and the who ecbs. members of the ecbs are scientists from national control agencies, academia, research institutes, public health bodies, and the pharmaceutical industry acting as individual experts and not as representatives of their respective organizations or employers. its work is based on scientific consensus achieved through this international consultation and collaboration. this committee, which directly reports to the executive board, has met on an annual additionally, who has been particularly active in the specific field of blood products and related biologicals. it has provided technical guidance and quality assurance tools to dras, national control laboratories, and manufacturers to support implementation of quality and safety systems for the production and control of blood products and related in vitro diagnostic devices worldwide. indeed, many countries have significant difficulties in fulfilling their responsibilities in this field because processing blood (with inherent variability due to the nature of the source materials) is a highly specialized process that requires a high degree of expertise. this development of who international reference materials and guidelines supports the technical capacity of national dras and assures the compliance of manufacturers to quality and safety measures globally in order to prevent transmission of diseases via blood products. it also contributes to technology transfer, global cooperation, and harmonization of regulations via the blood regulators network (brn). finally, the who has been very involved in the development of standards and guidelines regarding vaccines due to the importance of these products in public health. v moreover, who established the "prequalification of vaccines" (regarding the acceptability, in principle, of vaccines from different sources for supply) to help the united nations children's fund (unicef) and other un agencies that purchase vaccines. finally, through its regulatory pathways initiative it also helps to address the challenges faced by developing countries that are targets for clinical trials or introduction of new vaccines not registered in the country of manufacture. the objective is to support the establishment of regulatory mechanisms for the licensing of products in those countries that have not yet fully developed the expertise for the review of technical applications. this is achieved via workshops and technical assistance in collaboration with the european medicines agency (ema) through its article scientific opinion procedure, w the us fda, and other national dras in developed countries. a developing countries' vaccine regulators network (dcvrn) was created in september , and regional initiatives were also established. in many countries (developed and undeveloped), there is recognition of the significant need for research and development of medicines specifically for pediatric use (or data from pediatric studies using medicines that have been developed for adults). this lack of pediatric data became an important problem despite many initiatives from different regions or countries. the lack of suitable pediatric medicines, paired with inconsistent regulatory frameworks, poses significant risks to a particularly vulnerable patient population. the overall aim of the pmrn x is to promote availability of quality medicines (including biological medicines and vaccines) for children by facilitating communication, collaboration, and regulatory harmonization across manufacturing, licensing, and research [ ] . more specifically, among several objectives, this network tries to: ▸ provide a forum for discussion between worldwide dras to build awareness of pediatric medicines regulatory considerations ▸ facilitate the collaboration, discussion, and work towards consensus on regulatory standards for pediatric medicines (i.e., the development of international recommendations and common standards for clinical trials and registration of medicines for children based on the existing ich, ema, and us fda guidelines) ▸ strengthen licensing (approval) systems for pediatric medicines by increasing regulatory cooperation, information sharing, and training traditional medicines y have been used in many countries throughout the world over many centuries. today, these medicines still represent an important part of healthcare in some countries. z for example, more than countries have regulations for herbal medicines, but practices of traditional medicine vary greatly from country to country and from region to region, as they are influenced by factors such as culture, history, personal attitudes, and philosophy. however, while it is often necessary to tailor legislation and delivery to reflect the needs and traditions of the individual countries, a number of themes and issues are common, such as the importance of practitioner training, the issues related to safety, the need to enhance research into both products and practices, and the importance of labeling. also, the use of traditional medicines has expanded globally and has gained popularity in the last few decades. specifically, these practices have not only continued to be used for primary healthcare of the poor in developing countries, but have also been used in other countries where conventional medicines are predominant in the national healthcare system. aa with this tremendous expansion in the use of traditional medicines worldwide, safety and efficacy as well as quality control of herbal medicines and traditional procedure-based therapies have become important concerns for many of these countries. for this reason, who has been increasingly involved in developing international standards and technical guidelines for these types of medicines, and also in increasing communication and cooperation between countries [ ] . the challenge now is to ensure that traditional medicines are used properly, and to determine how research and the evaluation of traditional medicines should be carried out. supported by several wha and executive board resolutions, who has developed and issued a series of technical guidelines (e.g., guidelines for the assessment of herbal medicines, research guidelines for evaluating the safety and efficacy of herbal medicines, and guidelines for clinical acupuncture research). in , who developed draft guidelines for "methodology on research and evaluation of traditional medicine" that was finally approved in april [ ] . the purpose of this document is to promote the proper development, registration, and use of traditional medicines and to harmonize the use of certain terms in traditional medicine. moreover, in , who established a global network (called the international regulatory cooperation for herbal medicines [irch]) to allow communication and exchange between worldwide regulatory authorities responsible for the regulation of herbal medicines. the mission of this program is "to make quality priority medicines available for the benefit of those in need." this is achieved through evaluation and inspection activities, and in cooperation with national dras and partner organizations. the list of prequalified medicinal products (updated regularly) is used principally by un agencies (including unicef and the joint united nations programme on hiv/aids [unaids]) to guide their procurement decisions. but, the list has also become a vital tool for any agency or organization involved in bulk purchasing of medicines, as demonstrated by the global fund to fight aids, tuberculosis and malaria. the strategy is to apply unified standards of acceptable quality, safety, and efficacy and to build the capacity of staff from national dras, quality control laboratories, and from manufacturers or other private companies, to ensure quality medicines. technical assistance, training, and capacity building are an important part of the program [ ] . when a product is included on the who list, the relevant product dossier has been evaluated and the manufacturing sites inspected by who-appointed assessors and inspectors and found to comply with who standards. who also recognizes the evaluation of products by some major dras that apply stringent standards for quality, including, but not limited to, the us fda, ema, and health canada. bb however, it is important to note that the inclusion of a product (or a laboratory) on this list does not imply any approval by who because it is the sole prerogative of national authorities. who inspections are done by a team of inspectors, including: ▸ an inspector/expert from one of the pharmaceutical inspection co-operation scheme (pic/s) countries ▸ a who representative (inspector/expert) ▸ an inspector (or inspectors) as an observer from the national dra of the country in which the laboratory is located at the end of , the who list of prequalified medicines included products (manufactured in countries); a total of quality control laboratories had been prequalified (covering all who regions). the program had also prequalified its first active pharmaceutical ingredients (apis) [ ]. the above projects are specifically related to the harmonization of pharmaceutical regulations and regulatory standards related to medicinal products. however, it is important to note that several other who projects not directly related to the harmonization of pharmaceutical bb when a product is listed with a reference to us fda or ema, the alternative listing procedure was used, and the products have been added to the list relying on the assessment and inspections conducted by the us fda or ema. regulations cc have been or are also very important because they facilitate implementation of common systems, agreements on terminology, and the establishment of a forum for exchange of not only information, but also expertise and experience. these other who projects ultimately facilitate overall dialogue, cooperation, convergence, and harmonization between countries and regions. moreover, other more general projects can also promote regional and subregional collaboration and harmonization of the regulation. for example, one of the principles of the general ec-acp-who partnership established in dd was to "strengthen existing collaborative arrangements (e.g. pooled procurement in the caribbean) and catalyse the creation of new ones, which can work together to achieve pooled procurement, common policies and harmonization of legislation." in addition, who publishes many documents regarding pharmaceuticals and regulations (i.e., newsletters, periodicals, reports status, or special publications such as the who blue book [ ] ) that allow the diffusion and exchange of information and data everywhere in the world. for example, "who drug information" is a quarterly journal, launched in , which provides an overview of topics relating to medicine development and regulation that is targeted to a wide audience of health professionals and policymakers. it communicates the latest international news and trends. finally, some other specific who projects are also very important in facilitating the implementation of the international standards. these following projects need to be reviewed even though they are not directly related to the harmonization of pharmaceutical regulations because they demonstrate the key role of who in the global regulatory system, and therefore show how this organization has the legitimacy to further coordinate global harmonization. ▸ who review of drug regulatory systems: to ensure that public health is appropriately supported, national regulatory capacity needs to be regularly assessed, areas of weakness need to be identified, and necessary measures need to be taken. the objectives of this review are to strengthen national regulatory and control capacity through the identification of specific needs and the provision of appropriate technical support and training. this is done via the evaluation of existing legal framework, regulations, and control activities in order to assess the national regulatory capacity against a set of predefined parameters. who can then provide technical input if gaps are identified. this activity is very important, especially in developing countries, to ensure that international standards can be appropriately implemented at the national level. it is also an important tool to have a clear status of national regulatory systems to evaluate appropriate needs from developing countries and therefore necessary support from regional and international organizations. the who multicountry study (involving only countries) also showed that such assessments represent significant opportunities to learn more about the strengths and weaknesses of dras and the different strategies used to improve drug regulation performance [ ] . the international health regulations (ihr), first adopted by the health assembly in and then significantly revised in in consideration of the growth in international travel and trade and the emergence or reemergence of international disease threats and other public health risks [ ] , were finally adopted by the th wha on may , and entered into force on june , . the ihr is an international legal instrument that is binding on all the who member states. these global rules were developed and implemented to enhance national, regional, and global public health security. its aim is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide. the stated purpose and scope of the ihr are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." the ihr has been used for the h n pandemic crisis [ ] . the revised ihr requires countries to strengthen their core surveillance and response capacities so that they can report certain disease outbreaks and public health events to who. building on the unique experience of who in global disease surveillance, alert, and response, the ihr defines the rights and obligations of countries to report public health events, and establishes a number of procedures that who must follow in its work to uphold global public health security. as mentioned above, this document was not specifically developed for pharmaceutical products, but is an important global tool that enhances cooperation between all countries in the world. indeed, even if this agreement does not specifically relate to the harmonization of pharmaceutical regulations, it is very interesting for many reasons. first, this project helps strengthen worldwide capacities for public health and global cooperation in general, which is important for the implementation of harmonized global standards. more importantly, this is one of the first agreements that manages public health as a truly global issue and proposes further action using an integrated international approach and network. it shows that further integrated global cooperation in the area of health (with who being at the center of this cooperation to coordinate this effort) is possible and beneficial [ ]. the mission of who's program on medicines and pharmaceutical policies is to support the achievement of the health-related mdgs by assisting governments and organizations to ensure global and equitable access to safe, effective medicines of assured quality. goal ee and target e ff are particularly applicable to who harmonization activities in the pharmaceutical domain. many of who's activities in the pharmaceutical domain support the achievement of these mdgs because they globalize the resolution of major public health issues (that cannot be resolved at the national/local level), they promote collaboration between countries and regions, and they provide tools and standards to allow such international collaboration. since its creation, who has indeed played a significant role in the global harmonization of pharmaceutical regulations. as per its mandate and the responsibilities defined in its constitution, it has developed and maintained numerous international standards, norms, guidelines, classifications, and nomenclatures through a rigorous, international, and independent scientific consultative process. in addition to this normative role, who has also established important networks to facilitate global cooperation. for example, icdras has been an important player in global regulatory harmonization. it launched many projects that have facilitated and promoted harmonization and cooperation between countries [ ]. cooperation projects have also been pioneered over the years with a specific interest in essential medicines. gg the who prequalification program has been an important step since it demonstrated that cooperation in the domain of medicine evaluation is possible and beneficial. indeed, this program has been very positive and its scope has continually been extended since its creation in . it has clearly accelerated the access of essential medicines worldwide (especially in low and middle income countries) [ ] . this model should be used to further develop regional and global collaboration for medicine evaluation. the example of the / pilot who/east african community (eac) collaborative procedure initiated to facilitate registration of prequalified medicines in the eac [ ] was positive. the overall aim was to identify a framework for who/eac, for joint evaluation and approval of dossiers and inspections of medicine manufacturing sites, and to ensure that these assessments are integrated into national regulatory decision making. two assessors each from three eac countries (kenya, tanzania, and uganda) and six who assessors jointly assessed two product dossiers submitted by a single manufacturer. the dossiers were submitted in parallel, and with identical content, to each participating eac country and to who. the products were both prequalified. the principal benefit of this joint assessment was that once the products had been jointly assessed and approved by who/eac, they were granted immediate access to the markets of each of the countries that had participated in the joint assessment. also, such joint assessment contributes to harmonization of regulatory requirements at the regional level. this pilot who/eac project also exemplifies the role of who in providing technical assistance to countries and supporting local capacity building. indeed, by acknowledging the important role of adequate systems to implement sound and effective pharmaceutical regulation, who has supported developing countries in addressing their deficiencies or capacity problems through various types of training, assessment of regulatory capacity, and the recommendation of institutional development plans. these activities have been very beneficial in the past, but work needs to continue and grow in this domain, as problems still exist. indeed, the extent of implementation of standards varies from one region to another. there are a number of factors that explain observed weaknesses of medicine regulation, and these differ from country to country and depend also on the individual health systems. countries may vary regarding their registration system, and not all of them can implement a comprehensive medicine evaluation and registration system. also, who encourages regional and international collaboration among national dras in order to promote the harmonization of requirements and practices, and to strengthen professional competence [ ] . however, as recognized in its medicine strategy plan, cooperation with regional harmonization initiatives and organizations should be further enhanced [ ] . closer cooperation and coordination should also be sought with other global initiatives such as ich. further assistance to countries and cooperation with other regional and global initiatives are indeed possible and can be facilitated by who's regionalized structure. this specific threelevel organization provides multiple opportunities for engaging with countries. the headquarters focus on initiation, development, and global coordination of harmonization projects, while regional offices focus on technical support and building national capacities to support implementation. who's presence in countries also allows a close relationship with ministries of health and its partners inside and outside of government. this work at the regional and country levels is critical in ensuring that local and regional needs and challenges are taken into consideration when international standards and projects are developed. to conclude, although some improvements may address current challenges, who has been very successful and beneficial for all member states (developing and also developed countries). it has promoted evidence-based debate, analysis, and recommendations for health through its own work and that of the numerous formal and informal networks and collaborating centers around the world. these networks facilitate lively cooperation between scientists across nations and allow governments to jointly tackle global health problems. development and promotion of global norms and standards in medicine is one of who's efforts that is widely perceived as being in an area in which who has a comparative advantage. this advantage is due to the recognition of who as the global leader and coordinating authority on global public health. the achievement of the mdgs and the renewal of primary healthcare are indeed unthinkable without who's norms and standards, policy guidelines, and technical cooperation. this is why the development and promotion of global norms and standards are an area of continued focus for who [ ] . it is indeed critical that who continue its work towards better harmonization and cooperation in the pharmaceutical domain. acknowledging the unique neutral and independent role of who, its numerous successes in the past, and its nearly universal membership, it would be appropriate to further extend the leadership of who in this domain. this increased responsibility in the coordination of medicines would also further fulfill its mandate "to act as the directing and co-ordinating authority on international health work." [ ] the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ich) is a -year-old program. this unique initiative was established with the objective to bring together the dras of europe, japan, and the united states and experts from the pharmaceutical industry in these three regions to discuss scientific and technical aspects of pharmaceutical product registration. the drug regulatory systems in all three regions share the same fundamental concerns for the safety, efficacy, and quality of medicines. however, many time-consuming and expensive experiments have been repeated in all three regions to meet specific regional requirements. the goal of ich has been to increase harmonization of technical requirements to ensure that safe, effective, and high-quality medicines are developed and registered in the most efficient and cost-effective manner in order to be delivered to the maximum number of patients in the world without delay. these activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness. by making recommendations on ways to achieve greater harmonization of technical requirements for product registration, the objective is indeed to reduce or obviate the need to duplicate the testing carried out during the research and development of a new product. since its inception in , ich has evolved, through its global cooperation group (gcg), to respond to the increasingly global face of drug development, so that the benefits of international harmonization for better global health can be realized worldwide. this ich mission is embodied in its current terms of reference: ▸ to maintain a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the eu, us, and japan in order to ensure a more timely introduction of new medicinal products, and their availability to patients; ▸ to contribute to the protection of public health from an international perspective (added upon revision in ); ▸ to monitor and update harmonized technical requirements leading to a greater mutual acceptance of research and development data; ▸ to avoid divergent future requirements through harmonization of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products; ▸ to facilitate the adoption of new or improved technical research and development approaches which update or replace current practices, where these permit a more economical use of human, animal, and material resources, without compromising safety; ▸ to facilitate the dissemination and communication of information on harmonized guidelines and their use such as to encourage the implementation and integration of common standards. ich is comprised of representatives from six parties (the founding members of ich) that represent the regulatory bodies and research-based industry in the eu, japan, and the us: since , when ich was initiated, members have been added: ▸ the international federation of pharmaceutical manufacturers & associations (ifpma), the global nonprofit, nongovernmental organization, founded in to represent the research-based pharmaceutical, biotech, and vaccine sectors. its members are comprised of over leading international companies and over national and regional industry associations covering both developed and developing countries. ifpma is very involved in all subjects related to the improvement of global health. it has been closely associated with ich since its inception to ensure contact with the research-based industry (especially outside the ich regions). ifpma provides the ich secretariat. this important group of nonvoting members was established as a link between ich and non-ich countries and regions. the ich organization consists of the ich steering committee, ich coordinators, ich secretariat, and ich working groups. the ich global cooperation group (gcg) and the ich medical dictionary for regulatory activities (meddra) management board are subcommittees of the ich steering committee. the steering committee is the body that governs the ich, determines the policies and procedures, selects topics for harmonization, and monitors the progress of harmonization initiatives. this committee, established at the first ich meeting in april , has met at least twice a year since, with the location rotating between three regions (eu, japan, and us). during these committee meetings, new topics are considered for adoption, reports are received on the progress of existing topics, and maintenance and implementation of the guidelines are discussed. each of the six ich parties has two seats on the ich steering committee. each of the observers nominates nonvoting participants to attend the ich steering committee meetings. ifpma also participates as a nonvoting member. meetings of the ich meddra management board, ich gcg, and the regulators forum also occur during the same week as the steering committee meeting. ich working groups are the key players of the ich harmonization process. they are responsible for the development, implementation, or maintenance of ich guidelines. each of the six ich parties is represented in every working group. the official membership of an expert working group/implementation working group (ewg/iwg) is usually limited to two officials per party (one topic leader and one deputy topic leader). one of these topic leaders is nominated rapporteur (and sometimes a second is nominated co-rapporteur) by the steering committee. ich observers and interested parties hh can also nominate one representative. the pharmacopoeial authorities and representatives from the self-medication industry and the generic industry were invited to participate in the various working groups. finally, the three regulatory parties of the steering committee officially designate a regulatory chair when a new ich topic is formally adopted. the regulatory chair, designated among the three regulatory parties, regularly presents reports to the steering committee and ensures, in close collaboration with the rapporteur, timely execution of the ich process and adherence to the concept paper and business plan, including scope and timelines. depending on the type of harmonization activity required, the steering committee will endorse the establishment of one of three types of working groups: ▸ expert working group (ewg): these working groups are appointed by the steering committee when new topics are accepted for harmonization. the objective of each ewg is to review the differences in requirements between the three regions and develop scientific consensus required to reconcile those differences. it is charged with developing a harmonized guideline that meets the objectives defined in the concept paper and business plan. ▸ implementation working group (iwg): an iwg's task is to develop questions and answers (q&a) to facilitate implementation of existing guidelines. ▸ informal ewg/iwg: these working groups are formed prior to any official ich harmonization activity. their objective is to develop a concept paper and business plan. working groups meet in the same week as the steering committee and report on their progress to the committee. these one-week meetings are key for the ich organization as they allow for a regular review of efforts and achievements and adjust them if necessary. ich discussion groups are established to discuss specific scientific considerations or views (e.g., gene therapy discussion group) to facilitate the exchange of information on a specific topic, and ultimately the harmonization of the requirements. the coordinators are fundamental to the smooth running of the ich and are nominated by each of the six parties. an ich coordinator acts as the main contact with the ich secretariat and ensures that ich documents are distributed to the appropriate persons within the area of their responsibility. each party has also established a contact network of experts within their own organization or region in order to ensure that, in the discussions, they reflect the views and policies of the cosponsor they represent. the way this network operates differs according to the administrative structure of the party concerned. due to structural differences within the eu and mhlw, ich technical coordinators are also designated from the ema and pmda, respectively. they support the ich coordinator and facilitate every action of the steering committee members in the region, mainly by applying their scientific knowledge. their roles include acting as a contact point between the experts within the ema and pmda and the ich coordinator at the main regulatory body, and as a contact point with the ich secretariat. the ich secretariat operates from the ifpma offices in geneva (switzerland), and provides support to the ich steering committee. the secretariat is primarily concerned with preparations for, and documentation of, meetings of the steering committee, as well as coordination of preparations for working group (ewg, iwg, and informal wg) and discussion group meetings. the secretariat also provides administrative support for the gcg and the meddra management board, and maintains the ich website. the meddra management board, appointed by the ich steering committee, has overall responsibility for direction of meddra, an ich standardized dictionary of medical terminology. the board oversees the activities of the meddra maintenance and support services organization (msso), which serves as the repository, maintainer, developer, and distributor of med-dra. the management board is composed of the six ich parties, the medicines and healthcare products regulatory agency (mhra) of the uk, health canada, and who (as observer). the ifpma acts as a nonvoting observer on the management board and also chairs the board. as stated in its mission statement adopted by all parties in may , this group "promotes a mutual understanding of regional harmonization initiatives in order to facilitate the harmonization process related to ich guidelines regionally and globally, and to facilitate the capacity of drug regulatory authorities and industry to utilize them." this group ensures that the benefits of ich harmonization extend beyond the three ich regions (japan, eu, and us). the role of the gcg has changed over time as the focus on collaboration with the non-ich regions increased. from its creation to today, three phases can be differentiated: ▸ first phase ( to : information sharing outside ich: during these first three years, the gcg mandate was to share information outside ich (via preparation of brochures, presentations at international meetings, etc.). the objectives were to make available to any country or pharmaceutical company that requested it information on ich, ich activities, and ich guidelines. to this end, the group created a series of brochures intended to guide its activities as it answers requests for information and responds to non-ich regulators and industry: • ▸ second phase ( phase ( to : integration and collaboration with rhis: on november , , the ich gcg released their terms of reference in which they extended their action to act as the primary representative of the ich steering committee outside the ich regions, and equally as such as a conduit for non-ich parties to the ich steering committee. to do so, the group developed a privileged relationship with other non-ich harmonization initiatives. this key activity of the gcg had three advantages: • to share ich discussions and actions with the non-ich regions (allowing, when possible, harmonization and implementation of ich activities on a worldwide basis) • to promote and organize the involvement of the non-ich regions experts in ich discussions (via expert meetings, comments on step guidelines, and training on guidelines) • to facilitate interregional collaboration in order to promote transparency, better understanding of challenges and potential solutions to harmonization issues, leverage collective experience and knowledge (allowing easier standardization and development of good harmonization practice) when, in , the gcg decided to include representatives from the non-ich regions, the relationship with the non-ich regions became more collaborative and proactive, and the focus shifted from information sharing to a two-way dialogue to set up training and work on implementation. the results of these collaborations allowed the organization of workshops in the regions (e.g., apec workshops on clinical research inspections in and in thailand, the sadc quality guideline workshop in in zambia, and the apec quality guideline workshop in in china). as an example, the gcg also endorsed the apec life sciences innovation forum (lsif) sponsored workshop on ich quality guidelines (q , q and q ), held in september in seoul, south korea. this workshop was a great success for the spread of ich concepts and recommendations in this region as it was attended by more than participants (i.e., regulators, policymakers, academia, and industry) from countries. this type of workshop allows for practical explanation of ich guidelines, but also opens up discussion and exchange on the anticipated challenges and opportunities associated with the implementation of ich guidelines in order to better prepare implementation. the participation of these individual countries is distinct and complementary to the participation of official rhi representatives. in june , the inaugural meeting of the expanded gcg occurred. today, the key focus of the gcg continues to be the implementation of ich guidelines via the organization of training that began in . this training is indeed an important means for the promotion of better understanding of ich and ich guidelines beyond the ich regions. it developed a framework and mechanism for policy [ - ], a procedure for selection and prioritization, a template for training requests, definitions of roles and responsibilities for the organization and coordination of training activities, and a clearinghouse of training events for public access. these training activities (most of the time coordinated with the respective rhis) involve ich experts. during the meeting in october in yokohama, japan, the ich steering committee also decided to complement the gcg with the regulators forum. the ich regulators forum is the latest idea implemented by ich to increase communications and sow relationships between worldwide dras in order to ensure adoption and implementation of ich guidelines. following a proposal from the us fda in , the first meeting occurred in portland, oregon, us in june . this is a good complement to the gcg activities and includes authorities from the three ich regions, the observers, the rhis, and individual dras such as australia, brazil, china, chinese taipei, india, korea, russia, and singapore. this ich regulators forum allows frank discussion and the sharing of expertise among dras regarding best practices and challenges related to the implementation of ich guidelines and their impact on regulatory systems. this discussion assists in identifying training and capacity needs for action by the gcg. more importantly, it also builds mutual understanding, relationships, and trust. in the s, many varied efforts of harmonization of pharmaceutical regulatory requirements were conducted. first, the european community, who was developing a single market for pharmaceuticals, had shown that harmonization among different countries (with different medical cultures/practices and regulatory systems) was possible. at the same time, bilateral discussions between europe, japan, and the us on the possibility for harmonization were ongoing. the concretization of these ad hoc discussions happened during the world health organization (who) international conference of drug regulatory authorities (icdras) in paris in , where specific plans were agreed to. following this meeting, the three authorities approached ifpma to discuss a joint regulatory-industry initiative on international harmonization. the spirit and concept of ich was then agreed on between the different parties. in april , ich was officially created at its inaugural steering committee meeting, hosted by the efpia in brussels, belgium. representatives of the regulatory agencies and industry associations of europe, japan, and the us met primarily to plan an international conference, but at the meeting the wider implications and terms of reference of ich were also discussed. during this first meeting, the structure (including a steering committee and expert working groups) and the focus of ich activities (harmonization of safety, efficacy, and quality guidelines for human drugs and biological products) were agreed on. eleven topics were selected for discussion at the first conference. finally, it was agreed to expand the membership of the steering committee to include representatives from who, efta, and canada as observers because the harmonized guidelines could be useful to other non-ich regions. additionally, agreement was reached on the full name of ich. this name was chosen because one of the objectives of this group was to organize international conferences on harmonization. today, this name is associated with the overall initiative. the ich members officially confirmed their commitment to ich in a statement following the nd steering committee meeting: the parties cosponsoring this conference, represented at the nd steering committee meeting in tokyo, - october re-affirmed their commitment to increased international harmonization, aimed at ensuring that good quality, safe, and effective medicines are developed and registered in the most efficient and cost-effective manner. these activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimise the use of animal testing without compromising the regulatory obligations of safety and effectiveness. this conference will provide a unique opportunity for regulators and industry to reach consensus on the steps needed to achieve this objective through greater harmonization of technical requirements and to set out practical and realistic targets for harmonising requirements where significant obstacles to drug development and the regulatory process have been identified. recognising the substantial progress which has already been made in achieving harmonization within europe and through bilateral contacts between europe, japan, us, and other regions, the conference will seek to make further progress through a trilateral approach, with clearly defined priorities, methods of work and recommendations to both industry and regulatory authorities. whilst the conference will be an important step forward, it is not seen as an end in itself, but as a stage in a developing process, at a high level, between regulators and industry. the conference, its preparations, and follow-up activities will be conducted in an open and transparent manner and the presence of observers from other regulatory authorities and who is welcomed as a means of ensuring that the benefits of progress towards harmonization can be utilized world-wide. the conference will not only look at existing issues but will, based on past experience, seek to minimise future divergence of new registration requirements, as a consequence of technical progress. this initial ich statement is important because it provides the spirit of ich that has been followed and implemented in all subsequent ich activities since. from its creation in to , the initial focus of ich was to promote technical and scientific exchanges and discussions in order to find consensus on divergent technical requirements for registration of medicinal products in the ich regions. the goal was indeed to remove redundancy and duplication in the development and review process, such that a single data set could be generated to demonstrate the quality, safety, and efficacy of new products. during this first phase of its activities, the ich structure and process were defined, a lot of harmonization activities started, and several guidelines/standards developed. these first harmonization discussions were directed to both technical scientific content (related to quality, safety, or efficacy topics) and to format and communication tools (development of e and the start of meddra, electronic standards for transmission of regulatory information (estri) and common technical document (ctd) projects). during these first years, there was a growing interest in ich products beyond ich countries, and ich recognized early that harmonization within the ich regions would not suffice. however, during these first years, discussions and activities focused mainly on harmonization among ich parties (even though ich agreed to include observers as a link to the non-ich regions) because it was important to start the process with a limited number of committed parties. in november , the th international conference on harmonization (ich ) in san diego, california, us marked the end of the first years of ich activity. this conference provided an opportunity to evaluate results and to identify future needs in the area of international harmonization. at the conference, results were presented of a survey on utilization of ich guidelines confirming the positive contribution of ich in improving the international drug regulatory approval process, thus speeding the availability of new medicines to the public. in its statement titled "the future of ich" released at ich , the steering committee emphasized its intentions to focus the second phase of ich on implementing and maintaining existing guidelines, preventing disharmony, encouraging scientific dialogue and harmonization in new areas, and undertaking efforts towards global cooperation with non-ich regions and countries. during its second phase, ich continues to develop and implement tripartite guidance on specific technical requirements, and also increase its effort on the implementation of harmonized regulatory communication tools (i.e. meddra, ctd, estri, etc.) between authorities and industry. indeed, one of the areas of focus of this second phase is to ensure adequate implementation and maintenance of all the guidelines developed since . today, new guidelines continue to be developed, but less frequently. these new guidelines cover important technical subjects related to pharmacovigilance (i.e., guidelines e d, e e, and e f) or improvement of quality systems (i.e., guidelines q , q , and q ). new emerging topics (such as gene therapy) have also been discussed. however, the main challenge of ich is now to maintain and update the collection of guidelines already developed (i.e., follow the evolution of science, the experience gained, etc.). the second focus and priority of this ich phase has been, and continues to be, the extension of relationships with non-ich regions. it began with the creation of the gcg as a subcommittee of the ich steering committee in . since this time, ich has developed its relationship with non-ich regions and tried to facilitate the implementation of its standards and guidelines on a broader territory via collaboration and training. even if some relationships existed before, the gcg has been key for this geographical extension, and its role increased over time by moving from information sharing (via preparation of brochures, presentations at international meetings, etc.) to a collaborative and proactive dialogue (via the incorporation of non-ich regions and countries in the group). further evolution of the ich structure and the gcg's terms of reference are expected to continue to promote greater involvement of global regulators [ - , - ]. the first activity of ich was to organize the ich conference in , one year after its creation, in order to exchange points of view and discuss divergences among different parties involved. since ich , five additional conferences have been organized (table ) . these regular, well-attended conferences helped communicate the results of the harmonization activities to the largest possible audience. they were designed as an open forum (in breakout sessions) to gather additional public comments and provide updates on ich's scientific activities. these six conferences were well attended (e.g., , participants representing industry and authorities of over countries for ich and , participants representing industry and authorities of over countries for ich ). the early ich conferences were very important in increasing visibility on the process of harmonization and for ensuring that the process was carried out in a transparent manner. ich focused primarily on the finalization and completion of the ctd guideline. the last ich conference organized, ich , focused on areas such as new technologies and global cooperation with regulatory harmonization initiatives outside the ich regions. the three satellite sessions (related to "partnerships in harmonization," "gene therapy," and "meddra users' group") also confirmed the priorities of the meeting. during this conference, opportunities and new challenges for regulatory harmonization were discussed. the practical implementation of the ctd was also reviewed. after ich , no additional international conferences were scheduled. ich was planned to have taken place in europe in , but it was then canceled. instead, in may , the ich steering committee decided to replace these large international ich conferences with smaller and more frequent regional public meetings at the time of the ich steering committee meetings in the region (in order to benefit from the presence of steering committee members and ich experts). now that the ich process is well recognized, these smaller regional meetings allow for a better focus on regional issues and challenges. it also provides everyone the opportunity to meet with regulators and industry experts involved in ich activities, to be regularly informed on recent developments, and to exchange information on different hot topics. following this decision, regional meetings have been organized: ▸ in europe, the first eu regional public meeting took place in brussels, belgium in november . ▸ in north america, the first regional public meeting took place in washington, dc, us in october . ▸ in asia, the first regional public meeting took place in tokyo, japan in november . the ich process was first drawn up at the steering committee meeting in washington, dc in march , and amended in tokyo, japan in september . since then, the ich procedures have been revised several times . moreover, the new principles of governance, agreed to at the ich steering committee meeting in june , have revised the role of regulator and suggestions for new harmonization initiatives may arise in a number of forums (ich regional guideline workshops; regional and international conferences, workshops, and symposia dealing with research and development (r&d) and regulatory affairs; recognized associations; testing and registration of medicines, etc.). from the suggestion of a new harmonization action to the development of a new guideline (or modification of an existing guideline), there are three sequential steps: • submission of a concept paper to the ich steering committee by an ich party or an observer • endorsement by the steering committee • establishment of a working group the concept paper is the start of all ich harmonization activities. this document provides a short summary of the proposal (maximum two pages) and provides the information indicated below: • type of harmonization action proposed: for example, a new harmonized tripartite guideline and recommendation, or a revision of an existing guideline (indicating the category of procedure). • statement of the perceived problem: brief description with an indication of the magnitude of the problem currently caused by a lack of harmonization, or anticipated if harmonization action is not taken. • issues to be resolved: a summary of the main technical and scientific issues that require harmonization. • background to the proposal: further relevant information (e.g., the origin of the proposal, references to publications, and discussions in other forums). • type of expert working group: recommendation on whether the ewg should be a six-party group (for topics related to the r&d of a new drug substance and product) or an extended ewg (e.g., gmp). if necessary, further documentation and reports may be added to the concept paper. depending on the category of harmonization activity, a business plan may also be required. the business plan outlines the costs and benefits of harmonizing the topic proposed by the concept paper. only when the ich steering committee endorses a concept paper, and where appropriate a business plan, can the harmonization activity be initiated. a preliminary determination will be made on whether the topic is of sufficient interest to all parties and can be accommodated within the ich work schedule. the steering committee takes the following points into account when discussing a concept paper: • objectives and expected outcome of the harmonization action • categories of the ich process • composition of the ewg or iwg appointed to discuss the technical issues • setting a timetable and action plan for the ewg/iwg the concept paper may need to be revised and updated to reflect the steering committee discussions and conclusions. if the steering committee agrees that a topic may warrant further consideration and a business plan needs to be developed, an informal ewg/iwg will be formed and the group will work through e-mail, teleconference, and rarely, face-to-face meetings. the first tasks of the informal ewg/iwg will be to finalize a concept paper and develop a business plan. the revised concept paper and business plan will be sent prior to, and presented at, the next steering committee meeting. at its meeting in yokohama, japan (in june ), the ich steering committee agreed to have the final versions of the concept papers and business plans available on the ich website, for public information. depending on the type of harmonization activity proposed, the ich steering committee will endorse the establishment of either an ewg or an iwg. ich harmonization activities fall into four categories. as presented in table , these four categories cover the creation and development (stepwise progression), implementation, revision, and maintenance of guidelines. no procedure is in place for the withdrawal of existing ich guidelines because it happens very rarely. when guideline q f (stability data package for registration applications in climatic zones iii and iv) was withdrawn, an explanatory note was released following the endorsement of the withdrawal by the ich steering committee at its meeting in yokohama, japan in june . withdrawal notifications were also released by the ema, mhlw, and us fda. ▸ the formal ich procedure: the formal ich procedure follows a stepwise approach consisting of five steps with "decision points" at step and step that enable the steering committee to monitor the progress of the harmonization topics. this procedure is followed for the harmonization of all new ich topics. a streamlined procedure is also available when necessary. the procedure is initiated with the endorsement, by the steering committee, of a concept paper and business plan. an ewg with membership as specified by the concept paper is subsequently established. the ewg works to develop a draft guideline and bring it through the various steps of the procedure that culminate in step and the implementation in the ich regions of a harmonized tripartite guideline. • step : consensus building when the steering committee adopts a concept paper as a new topic, then the process of consensus building begins. the ewg prepares an initial consensus technical document, based on the objectives set out in the concept paper and in consultation with experts designated to the ewg. the initial draft and successive revisions are circulated for comments within the ewg, providing fixed deadlines for receipt of those comments. work is conducted via e-mail, teleconferences, and web conferences. if endorsed by the steering committee, the ewg will also meet face-to-face at the biannual steering committee meetings. interim reports on the progress of the draft are made to the committee on a regular basis. when consensus is reached among all ewg members, the ewg signs the step experts signoff sheet. the experts document with ewg signatures is submitted to the steering committee to request adoption under step a of the ich process. step a is reached when the steering committee agrees, based on the report of the ewg, that there is sufficient scientific consensus on the technical issues for the technical document or recommendation to proceed to the next stage of regulatory consultation.this technical document is made public on the ich website. on the basis of the technical document, the three ich regulatory parties take the actions they deem necessary to develop the "draft guideline." the consensus text approved by the three regulatory ich parties is signed off by the three regulatory ich parties as the step b draft guideline. • step : regulatory consultation and discussion regional regulatory consultation: at this stage, the guideline embodying the scientific consensus leaves the ich process and becomes the subject of normal wide-ranging regulatory consultation in the three regions. in the eu it is published as a draft chmp guideline, in japan it is translated and issued by the mhlw for internal and external consultation, and in the us it is published as draft guidance in the federal register. step guidelines released for consultation are also available on the ich website. dras and industry associations in non-ich regions may also comment on the draft consultation documents by providing their comments to the ich secretariat. after obtaining all regulatory consultation results, the ewg that organized the discussion for consensus building will be resumed. the same procedure described in step is used to address the consultation results into the step final document. the draft document to be generated as a result of step is called the step draft guideline. the step document with regulatory ewg signatures is submitted to the steering committee to request adoption as step of the ich process. step is reached when the steering committee agrees, on the basis of the report from the regulatory chair and the regulatory rapporteur of the ewg, that there is sufficient scientific consensus on the draft guideline. this endorsement is based on the signatures from the three regulatory parties to ich affirming that the guideline is recommended for adoption by the regulatory bodies of the three regions. in the event that one or more parties representing industry have strong objections to the adoption of the guideline on the grounds that the revised draft departs substantially from the original consensus, or introduces new issues, the regulatory parties may agree that a revised document should be submitted for further consultation. in this case, the ewg discussion may be resumed. the step final document is signed off on by the steering committee signatories for the regulatory parties of ich as an ich harmonized tripartite guideline at step of the ich process. • step : implementation having reached step , the harmonized tripartite guideline moves immediately to regulatory implementation, the final step of the process. this step is carried out according to the same national or regional procedures that apply to other regional regulatory guidelines and requirements in the eu, japan, and the us. information on the regulatory action taken and implementation dates are reported back to the steering committee and published by the ich secretariat on the ich website. in the eu, ich guidelines are submitted to the chmp for endorsement and the timeframe for implementation is established (usually six months). ich guidelines are available on the ema website. in japan, ich texts are translated into japanese and subsequent pharmaceutical and medical safety bureau notification for the promulgation of guidelines written in japanese is issued with an implementation date. the notifications on guidelines in japanese and also english attachments (ich texts) are available on the pmda website. in the us, the us fda publishes a notice with the full text of the guidance in the federal register. step guidance is available for use on the date it is published in the federal register. they are available on the us fda website. ▸ the q&a procedure: the q&a procedure is followed when additional guidance is considered necessary to aid in the interpretation of certain ich harmonized tripartite guidelines and ensure a smooth and consistent implementation in the ich regions and beyond. the q&a procedure is initiated with the endorsement of the steering committee of a concept paper. in the case of major implementation activities, the steering committee may also consider the need for a business plan. an iwg with membership as specified by the concept paper is subsequently established. the development and adoption of the q&a follow an established process. questions received from stakeholders are collected, analyzed, reformulated, and ultimately used as model questions for which standard answers are developed and posted on the ich website. the incoming questions are not answered individually, rather they serve to highlight areas that need additional clarification and are then used to develop a model question that will be answered in the q&a document. based on the level of guidance given by the answers, the iwg will assess whether the q&a document should be a step b document and published for comments or a step document and published as final. the document should be step b if, based on the answers provided, it sets forth substantial new interpretations of the guideline(s). the document should be a step if, based on the answers provided, it sets forth existing practices or minor changes in the interpretation or policy of the guideline(s). the document then follows the normal path of a step b/step document as per the formal ich procedure. the revision procedure applies when an existing adopted guideline needs to be revised or modified. it is almost identical to the formal ich procedure (i.e., five ich steps). the only difference is that the final outcome is a revised version of an existing guideline rather than a new guideline. the revision of a guideline is designated by the letter r after the usual denomination of the guideline. when a guideline is revised more than once, the document will be named r , r , r , and so on with each new revision. the maintenance procedure is used to add standards to exist ing guidelines and/or recommendations or to provide an update based on new information. this procedure has been used to amend the addendum of guideline s (r ), "detection of toxicity to reproduction for medicinal products & toxicity to male fertility," and guideline m (r ), "maintenance of the ich guideline on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals," on november , . it is currently applicable for changes to the q c guideline on residual solvents, the q b annexes, and m recommendations. in each case, the procedure is used when there is new information to be added or when the scientific/technical content is out-of-date or no longer valid. for the q c guideline, this maintenance procedure is used to revise the permitted daily exposure (pde) as new toxicological data for solvents become available. since its creation, and pursuant to its main goal, ich has released a number of guidances, each harmonizing technical requirements for registration of medicinal products. for each technical topic, the relevant ewg discussed the important question of whether there is scientific justification for the different regional requirements, and whether it would be possible to develop a mutually acceptable guidance. the objective of this scientific discussion is to reach a scientific consensus whatever the time and effort it requires [ ] (and not a "compromise" that would be an unacceptable decrease of certain regional requirements without scientific justification/ basis). ich has also worked on broader projects (e.g., meddra and ctd), which have been critical for the international exchange of information. the ultimate goal of ich activities is to remove redundancy and duplication in the development and review process such that a single set of data could be generated to demonstrate the quality, safety, and efficacy of a new medicinal product. the steering committee has given priority to harmonizing the technical content of the sections of the reporting data. the first ich guideline to deal with harmonizing the format of reporting data was e , "content and format of clinical study reports." this guideline describes a single format for reporting the core clinical studies that make up the clinical section of a registration dossier. the goal of developing a harmonized format has led to the creation of the ich guideline m , "the common technical document" (ctd), further described below. at the first ich steering committee meeting it was decided that the topics selected for harmonization would be divided into safety, quality, and efficacy in order to reflect the three criteria that are the basis for approving and authorizing new medicinal products. since then, ich has created a fourth category called multidisciplinary, which covers crosscutting topics that do not fit uniquely into one category or another. therefore, today ich topics are divided into four categories (quality, safety, efficacy, and multidisciplinary) and ich topic codes are assigned according to these categories. a summary of harmonized topics is provided below. an updated list of these guidances (including their status) can also be downloaded from the ich website (and also from the us fda, pmda, and ema websites). the guidelines under this category provide harmonization of information related to the development, manufacturing, and testing of medicines. they specifically cover stability testing (q ), validation of analytical procedures (q ), impurities testing (q ), pharmacopoeial text harmonization and interchangeability (q ), quality information on biotechnological products (q ), specifications (test procedures and acceptance criteria) (q ), gmp (q ), pharmaceutical development (q ), quality risk management (q ), and pharmaceutical quality systems (q ). in addition, the ich steering committee endorsed on april , the development of a new q guidance related to the development and manufacture of drug substances (chemical entities and biotechnological/biological entities). the guidelines under this category provide harmonization of information related to in vitro and in vivo preclinical studies. they cover all preclinical studies performed during the development of new pharmaceutical products, such as carcinogenicity studies (s ), genotoxicity studies (s ), toxicokinetics and pharmacokinetics studies (s ), toxicity studies (s ), reproductive toxicology studies (s ), pharmacology studies (s ), and immunotoxicology studies (s ). guideline s specifically addresses preclinical safety evaluation for the biotechnological products. the ich steering committee also endorsed on may , the development of a new s guideline that provides preclinical guidelines on oncology therapeutic development. finally, the photosafety evaluation of pharmaceuticals was endorsed as a new topic (s ) by the ich steering committee in june . the guidelines under this category provide harmonization of information pertaining to the clinical evaluation of pharmaceutical products. most of these guidelines relate to the assessment and management of safety data (e and e guidelines). these guidelines cover: • all the above efficacy guidelines can be applied to all therapeutic classes of drugs. until now, ich has focused the discussion on general (i.e., nontherapeutic class-specific) guidances. however, there are, in some therapeutic classes, individual drug evaluation guidelines among the three regions. differences between guidelines can result in obstacles to the mutual use and acceptance of clinical data. at the steering committee meeting in september , it was agreed that this should be adopted as a new area of work for ich, with the first such guideline being undertaken as a "pilot study" to assess the feasibility of extending work in this area. it was agreed to develop the first therapeutic class-specific guideline for antihypertensive drugs. no other guideline for clinical evaluation of a specific therapeutic category has been developed since this guideline (e ). this category was created to include guidelines covering topics that do not fit uniquely into one of the above three categories. in addition to the technical guidelines described in previous sections, ich set up ewgs to harmonize medical terminology (m : meddra), drug dictionaries (m ), and the format and organization of data in regulatory applications (m : ctd) in order to ease the exchange of information. the creation of electronic standards (m : estri) was also critical for the quick exchange of common, agreed-upon data. in november , the ich steering committee endorsed the establishment of an ewg for the electronic common technical document (ectd) and assigned the topic code "m " (even though work in relation to the ectd had previously been undertaken by the m ewg). all these harmonization initiatives are critical achievements that required a lot of effort from their respective working groups. they are important activities that greatly contributed to the international harmonization of pharmaceutical regulations because they harmonized and facilitated the exchange of information between regulators and pharmaceutical companies. due to the importance of these initiatives, each of them is detailed in the specific subsections below. guideline m covers a specific topic relating to both safety and efficacy issues. for this reason, it has been classified as a "multidisciplinary topic." this joint safety and efficacy guideline provides principles for nonclinical strategies (i.e., scope, timing, and duration of nonclinical safety studies) in relation to the conduct of clinical trials. it helps to reduce the differences between the ich regions and it also provides recommendations to reduce animal use during research and development (e.g., inclusion of any in vivo evaluations as additions to general toxicity studies instead of performing separate studies). this guideline is definitively aligned with the overall ich objectives, as its purpose is to facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the rs (reduce/refine/replace) principles, and reduce the use of other drug development resources. it clearly promotes the safe and ethical development and availability of a new pharmaceutical as quickly as possible. finally, the ich steering committee endorsed (in june ) the "assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk" as a new topic (m ). meddra was developed by an ich ewg in the early s. it was designed to support the classification, retrieval, presentation, and communication of medical information internationally and throughout the product regulatory cycle. prior to meddra, different medical dictionaries (and also different versions of these dictionaries) were used, such as the world health organization adverse reaction terminology (who-art), the coding symbols for a thesaurus of adverse reaction terms (costart) from the us fda, and the japanese adverse reaction terminology (j-art) from the mhlw. at that time, several worldwide authorities were looking for a more cost-and time-efficient way of processing suspected adverse reaction reports (e.g., the united kingdom medicines control agency [uk mca] were developing a new system of coding called adroit). it became obvious that this activity should fall under the auspices of ich. the goal of ich in developing meddra was to have an internationally recognized standard, and medically rigorous and well-maintained terminology to facilitate communication. it is indeed one of the most important ich projects for ensuring the global exchange of clinical information. this international medical terminology is particularly important in the electronic transmission of adverse event reporting (both in the pre-and post-marketing areas), as well as in the coding of clinical trials data. the meddra dictionary is a multi-axial terminology that provides a set of terms that consistently categorizes medical information. it includes terminology for symptoms, signs, diseases and diagnoses, and therapeutic indications. it is organized by system organ class (soc), divided into high-level group terms (hlgt), high-level terms (hlt), preferred terms (pt), and finally into lower-level terms (llt). the meddra dictionary has been translated into many languages. as the terminology itself does not contain specific guidelines for its use, an ich working group has been charged to develop two guides: ▸ "meddra term selection: points to consider": this document was created to achieve consistency in the way users assign particular terms to particular symptoms, signs, diseases, etc. ▸ "meddra data retrieval and presentation: points to consider": this document provides guidance on retrieval and on sorting and presenting data in the most understandable and reproducible way for the benefit of drug development, pharmacovigilance, and risk management. these two documents provide a best practice approach for the use of meddra. they are revised for each new meddra version release. in addition, the meddra dictionary includes standardized meddra queries (smqs) that were developed (in collaboration with cioms) to facilitate the retrieval of meddra-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development. smqs are groupings of terms from one or more meddra system organ classes (socs) that relate to a defined medical condition or area of interest. they are intended to aid in case identification. because the terminology requires constant updating and maintenance, it was agreed that a maintenance and support services organization (msso) would be needed to carry out this task and to distribute the terminology, on license, to users in industry and regulatory agencies. the msso, contracted by ich with technical and financial oversight by the meddra management board, is tasked to maintain, develop, and distribute med-dra. since the release of version . in , meddra has become the accepted international standard for all worldwide regulatory activities (meddra is not yet mandatory in the us). as a single global, standardized medical terminology, meddra speeds the exchange of clinical information, facilitating research and safety monitoring, and making the regulatory approval process more efficient and responsive. different translations of meddra have been released. in march/april , meddra was also implemented in the who vigibase, providing a global repository of meddra-coded safety data that can be used as a substantial tool for pharmacovigilance. during a meeting on october - , in yokohama, japan, the meddra management board announced fee reductions for lower revenue subscribers. these reductions are in keeping with the meddra management board's goal of facilitating the use of med-dra for all users. since january , access to meddra has been free for academic organizations, hospitals, healthcare providers, and other users involved in noncommercial activities. the objective of the electronic standards for transmission of regulatory information (estri) project was to facilitate international electronic communication. to this end, an ich multidisciplinary expert working group (called m ewg) was established during the ich meeting of in brussels, belgium. the m ewg was to evaluate and recommend estri that meet the requirements of the pharmaceutical companies and dras from the three ich regions. since , the m ewg has developed the technological framework and recommended solutions for international information exchange. this was obtained by gathering requirements, assigning specific tasks, evaluating international standards and products, and recommending a functional architecture. this project included the verification of procedures for consistent, accurate information transfer, and the evaluation of encryption technologies and key certification procedures for the transfer of regulatory information. the working group has undertaken test projects to define logical electronic communication standards in order to ensure the integrity of information and data exchange between pharmaceutical companies and authorities. to allow flexible change, some of the activities of the ewg result in recommendations that do not follow the formal ich step process. they are agreed upon in the ewg, signed by all parties of the ewg, and are endorsed by the ich steering committee at its different meetings. these recommendations, which have been modified and improved over time, provide various open international standards that allow for the international transmission of information regardless of the technical infrastructure. to facilitate the use of these recommendations, the m ewg has also developed a glossary for the technical terms. today, six m recommendations are available. they cover and standardize general aspects, but also the choice of file format and information transfer as described in table . recommendations were also prepared for the choice of physical media (i.e., floppy disks, cd-r, and dvd-ram). because these physical media are not relevant anymore, these recommendations were retired in june . in addition to the recommendations, the m ewg also developed several specifications with regard to the electronic exchange of information: ▸ the first specification developed by the m ewg was related to the electronic transfer of the individual case safety report (icsr) presented in ich guideline e b (data elements for transmission of individual case safety reports). following the development of the e b guideline, it became necessary to work on an electronic specification to guide the pharmaceutical companies on how to provide the information required by the e b guideline. indeed, successful electronic transmission of icsr relies on the definition of common data elements (provided in the e b guideline), but also a standard electronic transmission procedure. the first version of this specification was approved by the steering committee under step in . since then this specification has been modified because its implementation and use had to be aligned with the evolution of the ich e b and m (meddra) guidelines. as a result of this activity, adverse event (ae) data can be extracted, populated, and electronically transmitted in the manner specified by the ich icsr message from safety and surveillance databases. even if it has required a lot of work, the implementation of electronic reporting of icsrs based on the ich e b, m , and m standards progressed very rapidly across the ich regions. thanks to these standards, pharmaceutical companies can now exchange case reports electronically via gateway with some dras (such as the us fda or ema). ▸ the second specification developed by the m ewg was the electronic common technical document (ectd) created as the electronic message for the common technical document (ctd) detailed in ich guideline m . this specification has since been maintained by the ectd iwg. the ectd specification, based on xml (extensible markup language) technology, allows for the electronic submission of the ctd from applicant to regulator, taking into consideration the facilitation of the creation, review, lifecycle management, and archiving of electronic submissions. while the table of contents is consistent with the harmonized ctd, the ectd also provides a harmonized technical solution to implementing the ctd electronically. this ectd specification is applicable to all modules of initial registration applications and for other submissions of information throughout the lifecycle of the product, such as variations and amendments. the backbone has been developed to handle both the regional and common parts of submissions. implementation of ectd has begun across the ich partner and observer regions. for example, since january , , all electronic submissions to the us fda are required to be in ectd format. ▸ in , the m ewg published the first version of the study tagging file (stf) specification, which is supplemental to the ectd. this specification has since been modified several times. for each study included in modules and of an ectd submission, the stf includes information allowing for the identification of all the files associated with this specific study. this is additional information to the ectd backbone files that already include many items, but do not contain enough information on the subject matter of several documents (e.g., study report documents) to support efficient processing and review of applications. the common technical document (ctd) is one of the major and most well-known achievements of ich, and like all other big harmonization projects of ich, required much effort. it provides a harmonized structure and format for regulatory applications. the objective is to reduce the time and resources needed to compile applications for registration of medicines in the different ich regions. additionally, this new common format allows dras to have more consistent reviews, helping them to perform analysis across applications and to exchange information among them. before the development of the ctd, each region had its own requirements for the organization of technical reports in the submission and for the preparation of the summaries and tables. in japan, applicants had to prepare the gaiyo, which organized and presented a summary of the technical information. in europe, expert reports and tabulated summaries were required, and written summaries were recommended. the us fda had specific guidelines regarding the format and content of the new drug application (nda). in , the ich industry representatives proposed assembling the information generated during the development of a product in the same order. this proposal followed an industry survey in may that assessed the time and resources needed to convert an eu marketing authorization application (maa) into a us nda (and the reverse). this survey showed that an average of three to four months and to people were required for the conversion from one format to the other. with the acceptance in all three regions, the ctd now avoids the need to generate and compile different regional versions of most of the registration dossier sections. the ctd was adopted as an ich topic at the steering committee meeting that took place just before the ich meeting (july ). the ctd specifications reached step of the ich process at the steering committee meeting in july . after public consultation, step was achieved at the ich conference in san diego, california in november . on september , (at the washington, dc meeting), numbering and section headers were then edited for consistency and use in the ectd. the ctd consists of five modules (module is region specific, and modules , , , and are intended to be common for all regions): ▸ module includes administrative information (i.e., application form) and proposed prescribing information. ▸ module summarizes data included in modules , , and and is organized in seven subsections: • ctd the ctd is defined by a general ich guideline (m ) and three specific technical guidelines (m q, m s, and m e, which cover the quality, safety, and efficacy parts of the ctd, respectively). a q&a document is associated with each of these four guidelines to facilitate implementation of the ctd. the ich parties agreed to implement this harmonized format in the three regions by july . it is indeed used today in the three ich regions: it is mandatory in the eu and japan, and "highly recommended" in the us (the current legislation does not allow the us fda to make it mandatory). moreover, this format is also used in other countries (e.g., australia, canada, turkey, etc.), and derivatives of the ctd have been developed in other regions (e.g., the actd developed by the asean countries). this harmonized format is indeed one of the great successes of the ich process. while the realization of the ctd took many years, there is now a common format for the regulatory submissions across the three ich regions (europe, japan, and the us) and beyond. this facilitates pharmaceutical companies in making simultaneous filings in the ich regions as it eliminates the extensive work previously required to convert from one format to another. however, the ctd is not a "global dossier." it remains only a harmonization of format instead of a harmonization of content. this initial misunderstanding, certainly created by the desire of many people to accelerate the harmonization of technical requirements, led to a lot of criticism against this new format. however, the ctd cannot be a truly global identical dossier (including the same information/data/level of detail) if all technical requirements are not fully harmonized. moreover, the submission's content may also be different for several reasons, such as different individual regulations, legal status, or requirements, and different manufacturing situations for the three regions. indeed, although the ctd provides a common format for regulatory applications, the actual content must still meet local regulations, laws, and statutes. as a result, despite being presented in the same order, the required content of modules to may vary by region. for example, the integrated summary of efficacy/integrated summary of safety (ise/ iss) that were requested by the us fda before the implementation of the ctd are still needed. because these integrated summaries are unique to the us, the table of contents of the ctd does not specifically include them. a specific us fda guidance was released in june to help pharmaceutical companies decide where to place these us-specific ise/iss documents within the structure of the ctd. to conclude, even if the ctd is "only" an agreed-upon common format for the modular presentation of summaries, reports, and data, it provides obvious advantages. the ctd allows companies and dras to harmonize the terms and way of communication [ ] . having the same "language" will certainly help the harmonization of content, and ultimately the harmonization of technical requirements. indeed, regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. in addition, exchange of regulatory information between dras will be simplified. this increase of communication between authorities and between authorities and pharmaceutical companies will obviously facilitate expertise and opinion sharing (related to the safety, efficacy, and quality of the development product) in a timely manner that will ultimately provide benefits to patients by providing quality medicines more quickly on the market. like meddra, the objective of this project was indeed to support all aspects of pre-and post-approval pharmacovigilance activities as well as communication of regulatory information. for example, meddra and the harmonization of drug dictionaries are critical in the transmission of the icsr presented in ich guideline e b (data elements for transmission of individual case safety reports). the transmission of structured data (especially electronically) does imply the use of controlled vocabularies. before the ich initiative, there was no harmonized standard to document information and data on medicinal products. regulators in the different regions had established their own standards, which differed in data format, content, language, and applied standard terminology (e.g., terminology used for substances, routes of administration, pharmaceutical forms, etc.). the who drug dictionary, or a modified version of this product, was sometimes used. this lack of internationally harmonized standards related to core sets of medicinal product information and medicinal product terminology made the scientific evaluation, comparison, and exchange of drug data (especially in the area of pharmacovigilance) very difficult. the activity on the m guideline only began in . following the example and success of meddra, the ich steering committee at its meeting in november agreed to launch this new harmonization initiative and to develop a new tripartite guideline that defines the data elements and standards for drug dictionaries. during the ich meeting in tokyo, japan in february , who presented a white paper regarding the concepts of a global drug-coding dictionary. during this meeting, the steering committee agreed to convene an informal discussion group in brussels, belgium during the ich meeting in july to allow for a discussion of this proposal. an informal working group was then established to develop a concept paper and prepare a business plan. the m guideline was released for consultation at step of the ich process on may , , along with controlled vocabulary lists for routes of administration and units of measurement. this guideline was subsequently submitted to the iso for development under this process. step guideline was updated based upon feedback received during consultation in , as well as additional considerations following its submission to iso for development as an international standard. key parts of this updated guideline will be incorporated into the ich "implementation guide for identification of medicinal products message specification," which is currently undergoing development as an iso standard. ▸ achievements so far: for two decades, the ich process has achieved much success and benefited both dras [ - ] and pharmaceutical industries . more importantly, this harmonization has been pursued in the interest of patients and public health to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness. to achieve this objective, the goal of ich has been to promote international harmonization by bringing together representatives from the eu, japan, and us to discuss and establish common guidelines and standards. through the ich process, considerable harmonization has been achieved in the technical requirements for the registration of pharmaceuticals for human use. this is now a mature harmonization initiative. since its creation, over harmonized guidelines have been developed in the areas of quality, safety, and efficacy in order to eliminate duplication in the development and registration process. moreover, common harmonized tools for regulatory communication (meddra, ctd, estri) have also been made available. this represents an extraordinary contribution to the global harmonization of pharmaceutical regulations. these guidelines already form a solid basis for harmonized application of technical requirements during the registration process. while the technical output of the ich process has been very positive, the importance of the unique way in which ich operates should also be noted. indeed, in addition to the practical harmonization of specific technical items, one of the major outcomes of ich has been to create a forum that allows experts from different countries and with different backgrounds to communicate, exchange, discuss, and share their experience and information in a structured manner. this is of course an essential first step to any harmonization. finally, another important achievement of ich is to be well recognized on a worldwide basis. ich guidelines have been adopted and are now followed outside the ich regions (e.g., switzerland, canada, and australia, and also many rhis). although ich's initial focus was the development of guidelines for use in the ich regions, increased globalization drastically modified the international cooperation environment. in response to a growing interest from beyond the ich regions in the use of ich guidelines, the ich steering committee took the first step in march of establishing the ich gcg. in november , new terms of reference and rules were endorsed for the gcg with the aim of establishing partnerships beyond the ich regions to promote a better understanding of ich guidelines globally. since then, rhis from across the globe, but also representatives from dras and departments of health (doh) that are either a major source of api or clinical trials data have been invited to participate in the gcg meetings and listen to technical topics at the level of the steering committee (at the biannual ich meetings). in addition, as per a decision of the ich steering committee in november , invited rhis and dras/doh may now also nominate technical experts as active members of ich ewgs. the implementation of ich recommendations and standards outside the three ich regions is indeed very important as it allows industry to better develop medicinal products for the global market. as a consequence of this expansion to non-ich regions, training and capacity building have become a key focus of the ich gcg. in , the gcg implemented a strategy for addressing training and capacity needs to help ensure the most effective use of resources, opportunities, and the realization of desired outcomes. over the past few years, the gcg has responded to numerous requests for training, providing ich expertise both for the development of training programs and for the delivery of the training itself. today, the gcg and the ich steering committee continue to implement new tools to promote a better understanding and use of ich guidelines and recommendations ] . one of the drivers of this success is in the fact that this harmonization process is based on scientific consensus developed between industry and dra experts. before ich, the industry and regulators never sat at the same table in an international forum to discuss the science of drug development in order to develop best practices across different regions. this joint effort allows not only for the involvement of the best experts (from both the authorities and pharmaceutical industries) in specific technical discussions, but also for ensuring that discussions take into account both the regional legislations and the practical impact on the development of pharmaceutical products. this inclusion of both industry and regulators increases commitments to the common goal (i.e., implementation of the ich tripartite, harmonized guidelines, and recommendations) that has obviously been a key factor in the success of ich. the results of a survey on the impact of ich, presented during the ich conference in osaka, japan, showed a high degree of satisfaction by both dras and industry with the completed ich guidelines, and continuous support from both sides for ich activities. the second driver of ich's success is linked to its well-defined structure and process. in the beginning years of ich, the steering committee organized its structure around the working groups, which included world-recognized experts. this decision was critical because it allowed ich to have very robust scientific and technical recommendations, most of the time accepted and implemented without fundamental criticism. the steering committee has of course also been key as the governing body that gives direction, selects the topics for harmonization, and ensures completion of projects in a timely manner (not always easy when one's goal is consensus). in addition to the structure, the steering committee has also been able to define a process that supported this incredible harmonization task in a structured and organized way, supported by different players such as the ich secretariat and coordinators. indeed, the stepwise approach that has been put in place for the development of guidelines (the defined five-step process with decision points at step and step ) has been very important. this approach allowed for the creation of comprehensive drafts by a small number of experts (the best environment for facilitating focused discussion and development of consensus) and public review before implementation (which promotes transparency, and avoids surprises and post-approval issues). the creation of concept papers and business plans that the steering committee put in place at a later stage are also fundamental to ( ) define clear goals, and ( ) help to monitor progress towards the predefined goals. finally, the review of progress during regular meetings also ensures commitment, follow-up, and therefore the seriousness of this initiative. finally, the extension of ich beyond the ich regions was possible because the steering committee understood early on that its activity could not be restricted to the ich regions with the increasing globalization of drug development and manufacture. indeed, research and manufacture of new products is not confined to the three ich regions any longer. clinical trials are carried out throughout the world and many non-ich countries are involved in the development and manufacture of pharmaceutical products. to increase transparency and promote collaboration outside ich regions, the steering committee accepted observers (e.g., canada), worked with other international organizations (efta and who), and involved other regions/countries in this process via the ich gcg, which evolved over time. all these actions allowed the ich work to be expanded to most of the regions/countries in the world, and its harmonization benefits to be available worldwide. the collaboration with non-ich regions is today one of the priorities of ich in order to increase commitment of these regions and facilitate worldwide implementation of ich recommendations. ▸ limitations and challenges for the future: as mentioned above, ich has been an incredible contributor to the international harmonization of pharmaceutical regulations. ich has been successful in achieving harmonization (initially of technical guidelines and then on the format and content of registration applications), and has positively impacted the global development of new drugs. all parties agree that there is a need to maintain this harmonization in the interest of the patient and public health. now that the process and networks are in place, it seems indeed obvious that ich needs to continue its activities as one of the major players in the international harmonization of pharmaceutical regulations. further harmonization activities should be continued in a focused manner. however, in an evolving international environment, some aspects of this initiative need to be reviewed as new approaches may be needed. indeed, some aspects of this initiative may be optimized in order to better handle new and future challenges. the first challenge of ich, which the steering committee has already acknowledged, is the implementation and maintenance of already developed guidelines. the current magnitude of successful harmonization actions and the need for these to remain current in a rapidly changing environment calls for focusing more effort on the implementation and monitoring of ich commitments. development of iwgs or task forces to manage this challenge will be key to its success. this focus on implementation and maintenance should not, however, impact the work on new harmonization topics that still need to be discussed. these new topics for harmonization need to be rigorously assessed for need (i.e., scientific merit/emerging science) and feasibility (i.e., expected outcome, timeline, and resource requirements). another major challenge for ich is to confirm its worldwide expansion and to continue to develop and strengthen its collaboration and partnership outside the ich regions in order to better integrate these regions into the ich process. at the time of ich establishment, it was agreed that its scope would be confined to registration of new drugs and medicines in western europe, japan, and the us because the vast majority of the new drugs were developed and manufactured in these three regions. however, since then, there has been strong involvement of other parts of the world. canada and australia are key markets for pharmaceuticals, and are often involved in global clinical studies. more recently, the emergence of other countries has been recognized in all areas, including the pharmaceutical industry. as already recognized by the ich steering committee, the success of ich in the ich regions only will not be relevant any longer. the modification of the landscape obliges ich to review and broaden its objectives. the current organization (with the gcg) that initially responded to this increased globalization may not be the most appropriate solution for future stages of development. the ich organization and systems need to be reviewed and revised to better serve these broader objectives. in (during ich ), the ich steering committee reviewed its structure and concluded that this structure continues to be appropriate. however, in order to increase transparency, they welcomed appropriate participation of other interested parties in a flexible and ad hoc manner on topics that also affected them. a decade later, the new evolving environment requires a bigger revision of its structure and process. the ich steering committee understands this urgent need and has declared that a new ich organizational structure will be adopted. the steering committee will set the framework for new rules on governance, decision making, and membership [ - ]. finally, ich has to become more proactive in new emerging topics to prevent future disharmony. the gene therapy topic is an interesting example that demonstrates the previous lack of commitment of ich to "proactive harmonization." in september , the ich steering committee established a gene therapy discussion group (gtdg) in recognition of the rapidly evolving area of gene therapy medicines. the gtdg developed several ich consideration documents in this area. despite this first positive step/outcome, the development of these consideration papers and the activities towards the development of a new multidisciplinary guideline (guideline m ) was discontinued in september because "currently the ich regions do not have the resources to support the development of further ich consideration documents" in this domain . recently, the ich steering committee started to define a new proactive approach to identify and creatively pursue advancements in science . if ich succeeds in these challenges, it will certainly become a real international organization/forum (vs. a multiregional initiative) where proactive discussion on all past and new technical requirements for registration of pharmaceuticals for human use will be discussed. however, some of these challenges are not new. ich acknowledged these challenges years ago and has already tried to resolve them without succeeding (e.g., proactivity), confirming the difficulties of this task. to face these challenges, ich needs to revise its structure and engage a new phase in order to address the evolution of regulations and the globalization of drug development and manufacturing, and to promote better proactivity in harmonization. the ongoing ich reform is obviously an important milestone toward resolution of current limitations. europe was the first major regional bloc established after world war ii. following this, there have been many regional harmonization activities throughout the world, especially over the past years. countries in different regions of the globe have organized themselves into closer economic and political entities. these movements have transformed the world, both economically and politically, as they create new opportunities and also new challenges (e.g., the management of regulations and standards disharmony). these regional harmonization initiatives include members with closer interests and needs, compared to global initiatives, allowing further harmonization and cooperation. this level of harmonization is also essential for developing countries that may not have access to all global harmonization discussions due to sparse resources or lack of expertise. regional cooperation can represent their interests and challenges and allow them to be heard at the global level. ii this level of cooperation is also essential for establishing region-wide pooled procurement systems. very diverse initiatives (each with a different scope, objective, structure, and working model) were established due to different cultural, historical, and political contexts. they range from a simple technical and scientific intergovernmental cooperation model to an advanced integration model. ii although all countries are part of who, many countries are not represented at ich where global standards are developed. however, most of the major regional harmonization initiatives are today represented via the ich gcg group. the political and economic development of each region, and sometimes subregions, has indeed shaped the level of harmonization in the pharmaceutical area: ▸ scenario -pharmaceutical harmonization in the context of an economical and political integration: in certain regions, economic integration among countries implies integration of pharmaceutical regulations and the harmonization of technical standards. this degree of integration varies from one region to another (and sometimes from one subregion/country to another), but the harmonization of regulations and policies and standards are very important to create a consistent regional legislative framework and a common certification system for products across regions. europe is the best example in terms of advanced harmonization and integration with the development of a centralized system, institutions, and procedures for the registration of medicines to be marketed in the single market. jj ▸ scenario -pharmaceutical harmonization in the context of a general political agreement: other initiatives follow a general political agreement, mostly signed to avoid conflicts or wars in certain areas in the world or to facilitate economic growth and trade within a region (e.g., asia-pacific economic cooperation [apec]), without an integration goal. the output of this harmonization initiative is variable, but most of the time does not produce a deep harmonization of pharmaceutical regulations because it is not the primary objective of the agreement and therefore the resources and efforts from the countries for this pharmaceutical regulation harmonization are variable. ▸ scenario -pharmaceutical harmonization based on a specific intergovernmental agreement: in other regions, a simple technical and scientific intergovernmental cooperation has been established, focusing solely on the harmonization of pharmaceutical regulations. this is the case of the pandhr initiative in the americas where regional integration has not been the objective because countries continue to present very different systems and degrees of development, and there are no political commitments to create a single market. countries only cooperate to promote harmonization without creating common legislation and procedure. this is a scenario that produces good harmonization of pharmaceutical regulations because this is the focus of the initiative, compared to scenario above, which is a derivative of a broader political agreement. however, the risk and difficulty of this scenario is its implementation. because there is not an ultimate economic and political goal (e.g., developing a single market as in scenario ), implementation of the agreed-upon recommendations in the national law is somewhat difficult. its success clearly depends on the commitment of each country. it is important to understand that the scenarios discussed above can also be considered as steps. harmonization is a moving process and harmonization initiatives evolve over time. for example: jj this central system is supported by the national dras that also continue to operate their own registration systems for products limited to national markets. • the european model was initiated to stop war between its countries (scenario ), but has in the time since evolved to an integration model to create further economic and political bonds ( scenario ). • asean is another evolving initiative that may follow the european model. today, it is between scenario and . this evolution to a more integrated model is obviously easier when the members are somewhat limited in number and share common geographical, historical, and cultural roots. it is indeed very difficult to imagine that apec or pandrh will evolve towards integration models such as europe or asean. the european community was created after world war ii in order to develop a more peaceful europe by promoting cooperative projects. since then, it has rapidly evolved to become a unique partnership between european countries. the main goal of the community is the progressive integration of member states' economic and political systems, and the establishment of a single european market based on the free movement of goods, people, money, and services. the european union (eu) is not a federation like the united states of america (us), nor is it simply an organization for cooperation between governments like the united nations. it is, in fact, unique in that the countries that make up the eu (its "member states") remain independent sovereign nations, but pool their sovereignty in order to gain a strength and world influence that none could have on their own. kk with approximately million people (representing % of the world's population), the eu is today the world's third largest population after china and india, representing a huge single market. the eu's gross domestic product (gdp) is now bigger than that of the us, and it is the world's biggest exporter and importer [ ] . diversity is an important characteristic of the eu as symbolized by its motto, "united in diversity," with many differences existing among its member states. this diversity is a positive attribute of the union. however, considering the official languages and the major historic, social, cultural, and economic differences between member states, its development has not been easy. its diversity has also influenced its organization and the way the harmonization process has been structured. it is therefore very important to understand the history and organization of the eu in order to understand how the european pharmaceutical regulation has been structured over time. effectively alone and where cooperative action at the community level is indispensable. these include major health threats and issues with a cross border or international impact, such as pandemics and bioterrorism, as well as issues relating to free movement of goods, services, and people. acknowledging that all countries share common values (i.e., ensure high standards of public health and equity in access to quality healthcare), it is therefore logical that the eu has developed common standards for medicines. moreover, the implementation of a single market requires harmonization of the pharmaceutical market. the ability to travel freely, or to live and work anywhere in the eu, only makes sense if eu citizens can be sure to obtain the same level of healthcare wherever they go. therefore, a number of european community rules have been adopted to ensure the highest possible degree of protection of public health while promoting the free movement of medicines in an internal market without barriers. the european commission (ec)'s role is not to mirror or duplicate national activities, but to coordinate them. work on healthcare at the community level adds value to member states' actions, particularly in the area of illness prevention, including activity on the safety and efficacy of medicines [ ] . today, the european pharmaceutical system is well developed and the vast majority of requirements have been harmonized. this successful european cooperation in pharmaceuticals is also recognized on a worldwide basis due to its major contribution to the global harmonization of pharmaceutical regulations (via its active involvement in international initiatives such as ich and who). today the eu is composed of member states, but the size of the eu has changed over time as it has continually expanded since european integration first began in with only six countries ( table ). the final three enlargements (in , , and ) expanded the eu member states from to , and were rooted in the collapse of communism. it was a historic advancement that offered an unexpected and unprecedented opportunity to extend the union into central and eastern europe. today, the landmass of the eu covers million km ll and can rightly claim to represent a continent (plate ). stretching from the atlantic ocean to the black sea, it reunites western and eastern europe for the first time since they were separated by the cold war. in the future, the eu will continue to grow as an increasing number of countries express interest in membership. the treaty on european union sets out the conditions for such accession (articles and ): any european country which respects the principles of liberty, democracy, respect for human rights and fundamental freedoms, and the rule of law may apply to become a member of the union. the applicant country must meet a core of criteria (e.g., having stable institutions and a functioning market economy) in order to ensure that eu principles will be respected and that eu rules and procedures will be effectively implemented. this is a long and rigorous process that starts when the country submits an application to the council. today, iceland, the former yugoslav republic of macedonia, montenegro, turkey, albania, bosnia and herzegovina, kosovo, and serbia are candidates to join the eu, some of these countries being in more advanced stages of negotiation with the eu than others. membership is only granted when the necessary requirements are met and when candidate countries have demonstrated that they will be able to fulfill their part as members. in the eu regulatory network. for example, the ipa program supported the participation of nominated representatives of the concerned countries in selected meetings and training courses as observers. the program also supported the organization of conferences to prepare the countries for integration into the european regulatory network for medicines. these activities helped identify areas where additional action might be needed to ensure the smooth transposition of the eu "acquis communautaire" mm into the national legislation of these future eu member states. ▸ the specific case of iceland, liechtenstein, and norway: in july , iceland submitted its application for eu membership and the accession negotiations have now been opened. norway, despite two failed attempts by referendum to enter the european community in and the eu in , remains undecided whether or not it will apply once again for eu membership. presently, however, neither norway nor liechtenstein are candidates for eu membership. however, even if these three countries are currently not part of the eu, it is important to note that they have a specific strong relationship with the union through the european economic area (eea) agreement that entered into force on january , . this agreement allows these three eea european free trade association (efta) states nn to participate in the eu internal market on the basis of their application of internal market relevant acquis. oo all new relevant community legislation is dynamically incorporated into the agreement and thus applies throughout the eea, ensuring the homogeneity of the eu internal market. also, the eea agreement allows for eea-efta states to participate in the internal market's relevant community programs and agencies, albeit with no right to vote. in the pharmaceutical sector, norway, iceland, and liechtenstein have adopted the complete community acquis on medicines, and are consequently parties to the european procedures. in the case of the centralized procedure, the representatives from these three countries do not vote, but their position is stated separately in the opinion, where relevant, in the minutes of the committee and in the case of divergent opinions appended to the committee's opinion. their position is not counted in reaching the committee's opinion [ ] . according to decision no. / of the eea joint committee (which entered into force on january , ), when decisions on approval of medicinal products are accepted by the community, these three countries will accept corresponding decisions on the basis of the relevant acts. the liechtenstein authorities have transposed into their national legislation a provision that makes commission decisions automatically applicable on their territory. however, legally mm "acquis communautaire" is a french term referring to the cumulative body of eu laws, comprising the ec's objectives, substantive rules, policies, and in particular, the primary and secondary legislation and case law -all of which form part of the legal order of the eu. nn the european free trade association (efta) is an intergovernmental organization set up for the promotion of free trade and economic integration to the benefit of its four member states: iceland, liechtenstein, norway, and switzerland. although switzerland has many agreements with the eu, it is today not part of the eea agreement due to the rejection of accession by the swiss people. oo the eea agreement is concerned principally with the four fundamental pillars of the internal market, "the four freedoms" (i.e., freedom of movement of goods, persons, services, and capital). binding acts from the community (e.g., commission decisions) do not directly confer rights and obligations in norway and iceland, but first have to be transposed into legally binding acts in these states [ ] . since the end of world war ii, the eu has steadily become more established and organized. the unique european model (not a federation but a more integrated than simple cooperation between governments) requires a complex organization that not only protects the independent sovereignty of the member states, but also allows for the delegation of some of decision-making powers to shared supranational institutions. today, the structure in place was specifically designed to represent the interests of the community, the member states, and the european citizens. within this overall european structure and context, many special domains have been harmonized and organized to support the functioning of the single market. a number of institutions, committees, and technical bodies ( table ) play a significant role in the european pharmaceutical system. the roles and characteristics of these are briefly described in the following sections. ▸ the european parliament is the directly elected eu institution that represents the interests of the eu's citizens. its members are elected once every five years. its origins go back to the s and the founding treaties, but the lisbon treaty significantly increased its role in the decision-making process and budget approval. its legislative powers were reinforced by the extension of the co-decision procedure. today the european parliament is firmly established as a co-legislator, has budgetary powers, and exercises democratic control over all the european institutions. its work is organized through a system of specialized committees that review and prepare legislative proposals and reports to be presented at the plenary assembly. the committee on the environment, public health and food safety is responsible for the legislation covering pharmaceutical products and the ema. the european parliament has three working locations: brussels (belgium), luxembourg, and strasbourg (france). luxembourg is home to the administrative offices of the general secretariat. meetings of the entire parliament, known as "plenary sessions," take place in strasbourg and sometimes in brussels. committee meetings are also held in brussels. ▸ the council of the european union represents the individual member states. it meets in different configurations and is attended by one minister from each of the eu's national governments (depending on the agenda). health-related discussions are handled by the employment, social policy, health and consumer affairs council (epsco). as with the european parliament, the council was set up by the founding treaties in the s. it is a key decision-making body that, among other responsibilities (e.g., coordination of the eu's economic policies and foreign and security policy) shares lawmaking and budgetary powers with the european parliament. its work is facilitated by the committee of permanent representatives (coreper), which is responsible for preparing the work of the council of the european union (all issues must pass through coreper before they can be included in the agenda for an eu council meeting). this committee consists of the member states' ambassadors to the eu. these permanent national representatives and their team are located in brussels, belgium, and protect national interests at the eu level. ▸ the european commission (ec) is independent of national governments as it represents and upholds the interests of the eu as a whole. it acts as the "guardian of the treaties" but remains politically accountable to the parliament. like the parliament and council, the ec was set up in the s under the eu's founding treaties. a new commission, which is formed by a president (designated by the member states and approved by the parliament) and the "commissioners" (each of them responsible for a specific policy area), is appointed every five years. its role is to draft proposals for new european laws (which are presented to the european parliament and the council for adoption). it is also the eu's executive arm because it is responsible for implementing the decisions of the parliament and the council. this means managing the day-to-day business of the eu: implementing its policies, running its programs, allocating its funds, and representing the eu in international negotiations. the day-to-day running of the commission is done by its administrative officials, technical experts (via its various committees and groups), translators, interpreters, and secretarial staff (which represent more than , people). this staff is organized in departments, known as directorates-general (dg), and "services" (such as the legal service). the overall coordination is provided by the secretariat-general. each dg is responsible for a particular policy area and is headed by a director-general who is answerable to one of the commissioners. the regulation of medicinal products was previously under the dg enterprise and industry, but this policy area has been transferred to the dg health and consumers (sanco) as of march , . the commission is based in brussels (belgium), but it also has offices in luxembourg, representation in all eu countries, and delegations in many capital cities around the world. this "institutional triangle" produces the policies and laws (such as european pharmaceutical legislation) that apply throughout the eu. the court of justice upholds the rule of these european laws and makes sure that this eu legislation is interpreted and applied in the same way in all eu countries. the other institutions of the eu (the european council and the court of auditors) are critical for the functioning of the eu, but are not directly involved with the development and harmonization of pharmaceutical legislation. the eu institutions are supported by a number of other bodies (e.g., the european central bank, the european ombudsman, etc.). specialized agencies (e.g., the ema, the european centre for disease prevention and control, and the executive agency for health and consumers) have also been established to handle certain technical, scientific, or management tasks. this agency is headed by an executive director (who is its legal representative responsible for all operational and staffing matters) and has a staff of about full-time members [ ] . the management board is the supervisory body responsible for setting the agency's budget, approving the annual work program, and ensuring that the agency works effectively and cooperates successfully with partner organizations across the eu and beyond. in addition to its staff, the ema is composed of seven committees that conduct the main scientific work of the agency. these committees and their characteristics are reviewed below: • human use. the chmp plays a vital role in the eu marketing procedures as it is responsible for: -conducting the initial scientific assessment and issuing opinions on an maa for medicines registered via the centralized procedure (these opinions are used by the ec as a basis for its legally binding decisions) -coordinating post-marketing activities for medicines registered via the centralized procedure -arbitrating disagreements between member states during mutual recognition and decentralized procedures (arbitration procedure) -acting in referral cases, initiated when there are concerns relating to the protection of public health or where other community interests are at stake (community referral procedure) this committee (and its working parties) also provides assistance to companies during development, prepares scientific and regulatory guidelines, and cooperates with international partners on the harmonization of regulatory requirements for medicines. • the committee for orphan medicinal products (comp), established by regulation (ec) no / , is charged with reviewing applications from companies seeking "orphan medicinal product designation" for products they intend to develop for the diagnosis, prevention, or treatment of rare diseases (so-called "orphan drugs"). this committee is also responsible for advising the european commission on the establishment and development of a policy on orphan medicinal products in the eu, and assists the commission in drawing up detailed guidelines and liaising internationally on matters relating to orphan medicinal products. • submitted by pharmaceutical companies, and to adopt opinions on these plans. this includes assessing applications for full or partial waivers and assessing applications for deferrals of pediatric studies. this committee also assesses data generated in accordance with the agreed-upon pips, provides opinions on the quality, safety, or efficacy of a medicine for use in the pediatric population (at the request of the chmp or a member state), and supports the development of the european network of pediatric research at the european medicines agency (enpr-ema). ss • the committee for advanced therapies (cat) is a multidisciplinary committee established in accordance with regulation (ec) no / . it is responsible for providing scientific opinions on advanced-therapy medicinal products (atmps) and any scientific questions related to this field. for example, it prepares a draft opinion on each atmp application before the chmp adopts a final opinion on the granting, variation, suspension, or revocation of a marketing authorization for the medicine concerned. • the committee for medicinal products for veterinary use (cvmp) is responsible for preparing the agency's opinions on all questions concerning veterinary medicinal products. • the pharmacovigilance risk assessment committee (prac) is the last committee established by the ema to implement the new eu pharmacovigilance legislation. it is responsible for assessing and monitoring safety issues for human medicines. this includes the detection, assessment, minimization, and communication relating to the risk of adverse reactions, while taking the therapeutic effect of the medicine into account. it also has responsibility for the design and evaluation of post-authorization safety studies and pharmacovigilance audits. its recommendations are considered by the chmp when it adopts opinions for centrally authorized medicines and referral procedures, and by the cmdh when it provides a recommendation on the use of a medicine in member states. these ema scientific committees are comprised of members of all eu and eea-efta states (iceland, liechtenstein, and norway); some committees include patients' and doctors' representatives. they are supported by a number of working parties and related groups that have expertise in a particular scientific field. the committees consult with them on scientific issues relating to their particular field of expertise and delegate to them certain tasks associated with the scientific evaluation of an maa or drafting and revision of scientific guidance documents. in particular, the chmp is supported by an important number of groups (i.e., the biologics working party, the scientific advice working party, or the numerous scientific advisory groups specialized by therapeutic area); some are standing parties and some temporary groups. all these groups are made up of members selected from the european expert list maintained by the ema. indeed it is worth noting that the ema evaluation system works through a network of european experts made available to the agency by the national dras of all eu member states and of the three eea-efta states (iceland, liechtenstein, and norway). this system brings together the scientific resources and expertise of all these countries in a network of over , european experts who serve as members of the agency's scientific committees, working parties, or scientific assessment teams. the ema is today considered as the model of fruitful cooperation between national dras, working together within a community body to serve community purposes. also, to ensure that the european system is accessible to everyone, in the ema launched a dedicated office to provide special assistance to small-and medium-sized enterprises ( -for the collection, preparation, storage, distribution, and appropriate use of blood components in blood transfusions -for the transplantation of organs, tissues, and cells the role of the edqm is essential in europe in facilitating mutual recognition of quality control tests carried out on medicines and ensuring that patients receive the same quality of pharmaceutical products throughout europe. there is a substantial amount of interaction between the ema and the edqm. for example, the edqm representatives participate as observers of the ema's quality working party (qwp) and biologics working party (bwp) meetings, the gmp inspection services group meetings, as well as hmpc meetings at the ema. it is important to note that the european member state plays a significant role in the european pharmaceutical system. the ema works closely with the eu member states as well as the eea-efta countries (norway, iceland, and liechtenstein). member state representatives are members of the agency's management board while the agency's scientific committees and its network of , scientific experts are nominated by the member states. without their support and expertise, the ema would be unable to deliver on its responsibilities and mandate as laid down in european legislation. it is also important to realize that many medicines available in europe are not authorized by the ec on the recommendation of the ema. many products are still approved and supervised by the national dras via the mutual recognition procedure, the decentralized procedure, or national procedure. to coordinate their efforts, the member states established the heads of medicines agencies (hma) group, which is a network of the heads of the national dras. this hma is comprised of more than national agencies, some also having responsibility for veterinary products, medical devices, and cosmetics, and also pricing and reimbursement of products. the ema is also a member of the hma. the first meeting of the hma took place in amsterdam (the netherlands) at schiphol airport, on february , . the hma is focused on eu coordination and harmonization, decision making, and consensus on strategic issues of the european medicines regulatory network. its aim is to foster an effective and efficient european medicines regulatory system. more specifically, it works towards the following key objectives [ ]: ▸ addressing key strategic issues for the european medicines regulatory network, such as the exchange of information and sharing of best practices ▸ collectively being responsible for all areas of medicines regulation, including the mutual recognition and decentralized procedures ▸ focusing on the development, coordination, and consistency of the network ▸ supporting the network by providing high-quality professional and scientific resources ▸ providing a focus for making the most effective use of scarce resources across the network, such as developing and overseeing arrangements for work sharing to fulfill these objectives, the hma has been working on both general issues (i.e., strategy for telematics, and regulatory and scientific training) and technical and scientific topics (i.e., harmonization of clinical trials, coordination of products testing, and european risk management strategy) is support of the european medicines regulatory network. the hma's website contains the mri product index database, which includes all medicines approved in the member states according to the mutual recognition procedure. one interesting program that has been developed is the benchmarking of european medicines agencies (bema). the bema program assesses the systems and processes in individual agencies against a set of agreed-upon indicators. this is a good opportunity to exchange best practices and ensure harmonization of practices (i.e., assessment, inspection, etc.) between regulators within the network. coordination among the national competent authorities is not a simple task due to the heterogeneity of these national organizations. indeed, these authorities differ in size, historic origins, roles, resources, expertise, and funding. acknowledging these differences and also the legal, scientific, social, political, and financial challenges facing the network, the hma adopted a strategic paper that provides a plan of action for - [ ] . this second plan (the first one covered - ), highlights a number of key themes and areas of focus (i.e., pharmacovigilance, clinical trials, and communication) and also the need for international cooperation. the hma is supported by the heads of medicines agencies management group, the permanent secretariat, and working groups covering specific areas of responsibility. iceland, and liechtenstein) appointed for a renewal period of three years. observers from the european commission and accession countries also participate in the meetings. it also has many interactions with the ema to facilitate harmonization in several areas (i.e., pediatric regulation, variation regulation, and pharmacovigilance). it holds monthly meetings at the ema (which also provides the secretariat of the cmdh). in practice, approximately half of the time of the cmdh meeting is dedicated to discussions on procedural and regulatory issues, development of guidance documents, and oversight of the activities of the various cmdh subgroups and working groups, while the other half is devoted to trying to reach agreement for applications referred to the cmdh in the case of disagreement between member states. the gradual harmonization of pharmaceutical regulation in the eu has been dictated by the development and expansion of the community. it represents a good example of successful harmonization and also demonstrates the influence of the political and economical decisions on the harmonization process and its outcomes. ▸ the birth of the european union: the historical roots of the eu lie in world war ii. following this bloody, horrific war, several leaders in europe wanted to ensure that war could never happen again. their goal was to develop a peaceful europe and to stop the frequent wars via the promotion of cooperative projects. this initiative has been critical but not easily accomplished due to the post-war geopolitical situation and the beginning of the -year-long cold war that split europe into east and west. on september , , winston churchill called for a "kind of united states of europe" in a speech given at the zurich university. many attempts at cooperation were made in the following years (e.g., the customs convention between belgium, luxembourg, and the netherlands, and the organization for european economic cooperation). in , west european nations created the council of europe. uu it was a first step towards cooperation between them, but some countries wanted to go ever further. on may , , france's foreign minister robert schuman presented a plan for deeper cooperation and for the creation of an organized europe, which would prove indispensable to the maintenance of long-term peaceful relations. this proposal (known as the "schuman declaration") is considered to be the beginning of the creation of what is now the eu. may has since been designated as "europe day" to celebrate this event. the idea of this plan (inspired by jean monnet, top advisor of the french government) was to promote european peace by ( ) eliminating the age-old opposition of france and germany, and ( ) creating a framework and organization open to the participation of the other countries in europe. it proposed that the franco-german production of coal and steel be placed under a common high authority and that this new productive unit be open to all european countries willing to participate. the double objectives of this proposal were ( ) to set up common foundations for economic development as a first step in the federation of europe, and ( ) to make war materially impossible [ ] . based on the schuman plan, six countries (germany, france, italy, the netherlands, belgium, and luxembourg) signed the treaty of paris on april , to establish the european coal and steel community (ecsc) in order to run their coal and steel industries under a common management. it is important to note that the independence and the powers of the high authority have been critical, and differentiated the eu from other traditional intergovernmental organizations. indeed, the establishment of the ecsc was the first step towards a supranational europe. for the first time the six member states of this organization relinquished part of their sovereignty, albeit in a limited domain, in favor of the european community. building on the success of their first treaty, the six countries decided to expand cooperation to other economic sectors. on march , , under belgian minister for foreign affairs, paul-henry spaak, they signed the treaty of rome, establishing the european economic community (eec) (or "common market") allowing persons, goods, services, and capital to move freely across borders. the same day, they also signed a second treaty to create the european atomic energy community (euratom). despite the construction of the berlin wall in august , which increased the division between the east and the west, the cooperation between european countries continued to increase in different areas (e.g., food and agriculture, aerial navigation, the environment, etc.). on july , , the six countries created the world's largest trading group by removing customs duties on goods imported from each of the six countries to the others, allowing free cross-border trade for the first time. they also applied the same duties on their imports from outside countries. this eu internal market was reinforced in with the adoption of the "single european act" (which entered into force on july , ) to remove the final obstacles. in , the single market and its four freedoms (movement of goods, services, people, and money) had finally been fully established. additional agreements, such as the schengen agreement in , have since been signed to further facilitate movement within europe. today, this single market represents the core of the eu. in , following the collapse of communism across central and eastern europe and the dissolution of the pacte de varsovie, a decade began that would be critical for the future of europe. on december , , eu leaders agreed to start the process of membership negotiations with countries of central and eastern europe (bulgaria, the czech republic, estonia, hungary, latvia, lithuania, poland, romania, slovakia, and slovenia). the mediterranean islands of cyprus and malta were also included. in december , treaty changes agreed to in nice (france) and finally signed on february , were entered into force on february , and opened the way for enlargement of the eu by reforming its institutions and voting rules. this enlargement to the eastern european countries became effective on may , and january , . six years later, on july , , the accession of croatia brought the number of member states to countries. a single currency (euro [€]) was introduced on january , in countries (joined by greece in ) for commercial and financial transactions only. notes and coins were introduced in january . this introduction of the single currency followed a long stepwise process that started in the s with the creation of the "exchange rate mechanism" to maintain monetary stability. the next important step of integration (i.e., development of a political union with fully functioning institutions) took time and faced many challenges. the debate on the "constitutionalization" of europe started in when the european parliament adopted altiero spinelli's report proposing, in a "draft treaty on european union," a fundamental reform of the european community. in the s, two important treaties transformed the community: ▸ the treaty on european union (signed in maastricht [the netherlands] on february , , entered into force on november , ) represented a new stage in european integration as it opened the way to political integration. it was a major eu milestone, introducing the concept of european citizenship and setting clear rules for the future single currency and for foreign and security policy. under the treaty, the name "european union" officially replaced "european community." ▸ the treaty of amsterdam (signed on october , , entered into force on may , ), built on the achievements of the treaty from maastricht, laid down plans to reform eu institutions, gave europe a stronger voice in the world, and concentrated more resources on employment and the rights of eu citizens. building on this transformation of the community, the adoption of a european constitution and major institutional reform became an important topic of discussion for two reasons: ▸ succeeding treaties have spurred progress in the building and reforming of europe and its institutions. this long process marked by ever-closer integration progressively transformed europe from an economic community to a political union. ▸ the combination of the various treaties and protocols signed over years has made the european structure and legislation more and more complex. although the eu will certainly continue to grow, it is difficult to predict the next steps of integration due to the current geopolitical situation and the instability caused by the financial crisis. the evolution of pharmaceutical regulation harmonization and cooperation in europe represents an excellent example and model that needs to be analyzed in detail as it shows the different important steps necessary for harmonization success. a large body of legislation has been developed, with progressive harmonization requirements since the s. the first european directive related to pharmaceutical products (directive / /eec [ ]) was signed on january , . this text provides the european definitions of a "medicinal product" and a "substance" and set up some fundamental principles for the creation of the european pharmaceutical system such as: ▸ no medicine may be placed on the market of a member state unless a marketing authorization has been issued by the competent authorities following the review of an application submitted by the person responsible for placing that product on the market. ▸ quality, safety, and efficacy are the basis for the evaluation of an application by the competent authorities. ▸ the information included in the application should be updated on a regular basis. following this first directive, many texts followed over the years to further detail the european principles and requirements led by directive / /eec, to organize and structure the european system, and to add new requirements related to specific types of products or emerging problems. major texts and important steps in the development of the european pharmaceutical system are discussed below. however, it is important to note that many other legislative texts, guidelines, and other recommendations (including harmonized quality, and nonclinical and clinical requirements) have been prepared and released over the years to support the major legislatives texts listed in this section. directive / /eec was complemented by two additional directives (directives / /eec and / /eec) in may to provide further details on the analytical, nonclinical, and clinical standards and protocols to be applied during the development of medicines, and how the results of such studies should be presented in the maa. directive / /eec also established the idea of expert reports (that would later influence the structure of the ctd), the cpmp (that would later be part of the ema), and the first multi-state licensing procedure, which would then evolve progressively to become the current mutual recognition procedure (mrp). further clarification of requirements was provided by directive / /eec (which also modified the multi-state licensing procedure to facilitate its use), and directive / / eec (which established the notion of combination products and created a route for abridged applications in case of generics and literature-based applications). in , directive / /eec established the concertation procedure, which provided a simple community-wide licensing opinion (via a mandatory referral to the cpmp) for all new biotechnology products and optionally for high technology medicinal products [ ] . it was an important new step in building the european pharmaceutical system as this new procedure (the forerunner of the current centralized procedure) required further cooperation between national dras compared to the multi-state licensing procedure previously established. however, both procedures were still based on voluntary cooperation between the relevant national authorities, and each member state remained solely responsible for granting the marketing authorization. in , legislators extended the scope of the previous directives to specific types of products: vaccines, toxins or serums, and allergens (directive / /eec); radiopharmaceuticals (directive / /eec); and products derived from human blood or human plasma (directive / /eec). additionally, on april , , directive / /eec laid down the first common measures related to genetically modified organisms (gmos); several additional texts have since then been released on this topic over the years. finally, extension of the scope of the harmonization of homeopathic products was only made in via the adoption of directive / /eec. in , directive / /eec, which laid down the principles and guidelines of gmp, was adopted. in , four new directives covering the distribution of medicines were adopted to further establish the eu internal market and facilitate the free movement of products. they especially harmonized wholesale distribution (directive / /eec), the classification of products as subject to medical prescription or not (directive / /eec), the labeling of products (directive / /eec), and advertising principles (directive / /eec). despite all these texts adopted since , the resulting progress of completing the single market in pharmaceuticals was not satisfactory. it was therefore decided to fundamentally improve the authorization procedures. a new european pharmaceutical system was then created in (but only implemented in january ). this new system, still in place today, is based on two major texts that established, for the first time, "european decisions" binding to the member states: ▸ following the adoption of these european procedures, it was necessary to harmonize the system to vary the terms of marketing authorization. this was done via the adoption of two regulations in : regulation / (for the mrp) and regulation / (for the centralized procedure). additionally, acknowledging the increased complexity of the european pharmaceutical legislation, it was agreed to assemble all previous directives in one single text. this codifying directive, directive / /ec adopted on november , , was necessary because all the directives adopted since had been frequently and substantially amended. therefore, this directive regroups all legal requirements agreed-upon since (except requirements and legal provisions provided by regulation / ). this new directive has already been amended several times since its adoption, some of these amendments being the result of a major general review of the legislation and system discussed below. in , as directed by regulation / (article ), the commission conducted a major review of the operation of the new system implemented in . the goal of this audit, contracted out to independent auditors, was to review the extent to which the results achieved over the first five years have met the objectives (namely to enhance the creation of a single market in medicinal products, while ensuring the protection of public health and the development of the pharmaceutical industry). the audit report [ ] , known as the "cameron mckenna andersen report," includes the results of the extensive consultation carried out involving individual companies, all dras responsible for the authorization of medicines and the emea, patient and professional associations, trade associations, and relevant ministries. this audit highlighted the overall satisfaction with this new system, as both procedures had been perceived as contributors in both a qualitative and quantitative way to create a harmonized european community pharmaceutical market. ninety-two percent ( %) of companies and % of dras in the eu were satisfied or very satisfied with the centralized procedure. there was also general recognition of the very considerable contribution made by the emea and the eu telematics strategy to the successful operation of the system. however, this report also identified several issues and listed several possible improvements to the system. these criticisms were primarily directed towards the mpr for which it was agreed that the lack of real supervisory, management support, and liaison between member states had altered the application of the central principle of mutual recognition. concerned member states were continuing to assess applications. regarding the centralized procedure, it was felt that it should be opened up to a broader range of products and that the "decision-making process" of the commission (post-cpmp opinion) should be reduced and improved. finally, it was also interesting to note that the european procedures had not yet produced any real dividends in terms of cost efficiencies through economy of scale. there was also a need to reduce the administrative burden where there were no public health implications (e.g., in relation to minor variations to existing approvals). this evaluation of the regulatory processes was not only very timely with the emerging technical challenges (e.g., gene therapies, etc.), but also with the political challenges in preparation for eu expansion [ ] . indeed, there was little doubt that the upcoming major enlargement of the eu (in , and involving additional countries) would accentuate the weaknesses of the system if both the structural and process issues were not resolved by then. based on this review of the eu pharmaceutical legislation and various public hearings, the ec concluded that on the whole the system had proven appropriate and suitable for its purpose and therefore it was recommended that it keep its main principles and structures. however, the ec also proposed several adaptations of the system and legislation in order to better achieve four major objectives [ ]: ▸ assure a high level of public health protection, notably by increased supervision of the market through the strengthening of inspection procedures and of pharmacovigilance. ▸ complete the single market for pharmaceutical products, taking into account the stakes of globalization, and establish a regulatory and legislative framework that favors the competitiveness of european industry. ▸ respond to the challenges of the future enlargement of the eu. ▸ rationalize and simplify the system and improve its overall coherence and visibility and the transparency of its procedures. these proposals, such as opening up the centralized procedure to a broader range of products, establishment of a fast track procedure and conditional authorization, improvement of the transparency of the system, strengthening pharmacovigilance and supervision requirements, abolition of the renewal, control of the effective use of marketing authorization with the "sunset clause," improvement of the decision-making process after cpmp opinion, re-organization and increase of the role of the emea and its committees, major modifications to the mrp and creation of the decentralized procedure, and harmonization of data protection periods [ , ], have been further debated with the parliament and the council over subsequent years. most of them have finally been implemented via the adoption of new or revised legislation and/or guidelines. one of the major legislative impacts has been the adoption of regulation ( finally, in addition to these critical texts that created the european system and general requirements, it is worth mentioning the following additional legislative texts adopted over the past years on important specific subjects (see part i- . the current european pharmaceutical system has progressively developed over the years via the adoption of agreed-upon policies. since many texts have been adopted with the aim of achieving a single market for pharmaceutical products. as noted above, several european institutions and technical bodies, together with the eu member states, are involved in the harmonization of european pharmaceutical regulation. the european harmonization process lies in the adoption of eu laws [ ] that can be categorized as follows: ▸ the "primary" legislation: the treaties are binding agreements between eu member countries. they state eu objectives, rules for eu institutions, how decisions are made, and the relationship between the eu and its member states. they also form the basis or ground rules for all eu actions. this means that every action taken by the eu is founded on treaties that have been approved voluntarily and democratically by all eu member countries. for example, if a policy area is not cited in a treaty, a law cannot be proposed in that area. ▸ the "secondary" legislation: this is derived from the principles and objectives set out in the treaties. it includes the following texts: • regulations are the most direct form of eu law. as soon as they are passed, they have binding legal force throughout every member state and must be applied in its entirety across the eu. national governments do not have to take action themselves to implement eu regulations (i.e., regulations do not require any transposition by the national authorities). • directives are legislative acts that set out a goal that all eu countries must achieve. national authorities have to adapt their laws to meet these goals, but are free to decide how to do so. vv directives are used to bring different national laws in line with each other, and are particularly common in matters affecting the operation of the single market (e.g., product safety standards). they may concern one or more member states, or all of them. • decisions are individual acts relating to specific cases and are addressed to specific parties. they are binding only on those to whom they are addressed (e.g., an eu country or an individual company), and are directly applicable (no need for implementation into national law). decisions can come from the eu council (sometimes jointly with the european parliament) or the ec. vv each directive specifies the date by which the national laws must be adapted (giving national authorities room to maneuver within the deadlines necessary to take account of differing national situations). • recommendations are not binding, but allow the institutions to make their views known and to suggest a line of action (without imposing any legal obligation on those to whom it is addressed). • opinions are not binding. they are an instrument that allows the institutions to make a statement in a nonbinding fashion; in other words, without imposing any legal obligation on those to whom it is addressed. they can be issued by the main eu institutions (commission, council, parliament), the committee of the regions, and the european economic and social committee. the european parliament and the council of the eu share legislative power, which means they are empowered to adopt european laws (directives and regulations). in principle, it is the commission that proposes new "legislative texts," ww but it is the parliament and council that adopt them. the commission and the member states then implement them, and the commission ensures that the laws are correctly applied. the vast majority of european laws are adopted jointly by the european parliament and the council using a procedure known as "co-decision." xx this means that the directly elected european parliament has to approve eu legislation together with the council (the governments of the eu countries). in addition to this "ordinary legislative procedure," there are also other special legislative procedures (which apply only in specific cases) where the parliament has only a consultative role. the requirements and procedures for the marketing authorization of medicinal products, as well as the rules for variations to the terms of marketing authorizations and for the constant supervision of products after they have been authorized, are primarily laid down in directive / /ec and regulation (ec) no / (and their subsequent amendments). these texts additionally lay down harmonized provisions in related areas such as the manufacturing, wholesaling, or advertising of medicinal products for human use. in addition, various laws have been adopted to address the particularities of certain types of medicinal products and promote research in specific areas. in addition to the legal texts, many additional community or international documents and recommendations have been developed and support the harmonization and cooperation in the eu. the "introduction and general principles" of annex of directive / /ec, as ww the european commission is the only institution empowered to initiate legislation. before proposing a new text, it assesses the potential economic, social, and environmental consequences that they may have by preparing "impact assessments" (which set out the advantages and disadvantages of possible policy options) and by consulting interested parties. the commission will propose action at the eu level only if it considers that a problem cannot be solved more efficiently by national, regional, or local action. this principle of dealing with things at the lowest possible level is called the "subsidiarity principle," and has been reaffirmed in the lisbon treaty. xx the co-decision procedure was introduced by the maastricht treaty on european union ( ) , and strengthened and made more effective by the amsterdam treaty ( ) . with the lisbon treaty that took effect on december , , this procedure has been renamed "ordinary legislative procedure" and has become the main legislative procedure of the eu's decision-making system. amended, acknowledged these scientific and technical recommendations (i.e., "the rules governing medicinal products in the european community," ich guidelines, and monographs of the european pharmacopoeia). all community rules in the area of medicinal products for human (and veterinary) use are compiled in "the rules governing medicinal products in the european union" (eudralex), published by the ec. volume of this publication contains the body of the eu pharmaceutical legislation (i.e., regulations, directives, decisions, etc.). the subsequent volumes include guidelines yy developed to support this basic legislation: zz ▸ volume (also known as "notice to applicants"), first published in , contains all regulatory guidelines related to procedural and regulatory requirements (i.e., the presentation and content of the dossiers), and also the application forms. it was prepared and is regularly updated by the european commission in consultation with competent authorities of the member states and the ema. this notice has no legal power. in case of doubt, therefore, reference should be made to the appropriate community directives and regulations. also, in july , the information contained in chapter of volume a (concerning general information on procedures for marketing authorization) was transferred to ema and cmdh websites. ▸ volume consists of all the scientific guidelines for medicinal products for human use prepared by the committee for medicinal products for human use (chmp) in consultation with the competent authorities of the eu member states. the guidelines are intended to provide a basis for practical harmonization in the manner in which the eu member states and the ema interpret and apply the detailed requirements for the demonstration of quality, safety, and efficacy contained in the community directives. an updated list of scientific guidelines is accessible on the ema website. ▸ volume contains guidance for the interpretation of the principles of gmps for medicinal products for human and veterinary use. ▸ volume contained pharmacovigilance guidelines for medicinal products for both human use (volume a) and veterinary use (volume b). volume a was replaced by the ema "guidelines on good pharmacovigilance practice (gvp)" in [ ] . ▸ volume contains guidance documents applying to clinical trials. finally, in addition to the published rules listed above, a lot of other documents that do not have the status of a law or guideline (i.e., questions and answers [q&a], recommendations, public statements, position papers, reflection papers, etc.) are released by the ema to provide additional guidance. moreover, templates (e.g., assessment templates and guidance), internal standard operating procedures (sops), work instructions (wins), and policy covering both general and specific topics (e.g., pharmacovigilance, inspection, etc.) have been developed by the ema to improve consistency in activities and evaluations and to help ease the exchange of information. many technical requirements have been harmonized and published in europe to ensure that medicinal products throughout europe are of equal quality, safe, and efficacious. these are the three basic criteria that are always evaluated and taken into consideration when establishing the risk and benefit ratio. these criteria are evaluated through the quality, nonclinical, and clinical information included in all applications. of course, the level of quality/nonclinical/clinical documentation varies depending upon the type of products and the level of development, but they are always the basis of approval for the registration of a clinical trial or a new product. legal provisions related to these technical requirements are included in annex of directive / /ec and other relevant regulations or directives. in addition, scientific and technical guidelines are also prepared by the ema's committees (i.e. chmp, comp, pdco, etc.) and its working parties (in consultation with the competent authorities of the eu member states). guidelines developed by other technical bodies (e.g., the european pharmacopoeia) or international bodies are also used in europe. for example, europe is a founder and member of ich, and therefore all ich guidelines are also applicable in europe. ▸ quality: many european requirements are in place regarding the quality of the products (active substance, excipients, and finished products). detailed scientific guidelines have been developed to adequately cover pharmaceutical development, manufacture, packaging, control (i.e., specifications, analytical procedures and validation, and impurities), stability evaluation, and post-approval changes. moreover, guidelines for certain types of products (i.e., biologics, radiopharmaceuticals, medicinal gases, or herbal medicinal products) have been specifically released to take into account their specific challenges. these technical and scientific guidelines, together with the q&a document, provide a common interpretation of the european legislation and ensure harmonization of quality requirements. also, in addition to these guidelines, it is worth mentioning two other publications that have been critical in the harmonization of the quality aspect of medicinal products available on the european market: • good manufacturing practice (gmp) is one of the most important harmonized requirements that have been issued. as per directive / /ec and directive / /ec, all products (including investigational medicinal products) have to comply with the principles and guidelines of gmp. these gmp principles are laid down in directive / /ec. in addition, the ec has published detailed gmp guidelines in line with those principles in eudralex (volume ). this volume covers both the basic requirements for medicinal products (part i) and for active substances used as starting materials (part ii). particular considerations and conditions for specific products (biological products, radiopharmaceuticals, medicinal gases, products derived from human blood or plasma, herbal medicinal products, excipients, etc.) are also in place or under discussion. under this eu system, manufacturers and importers of medicines located in the eea are subject to a manufacturing authorization and come under the supervision of the competent authorities of the member states (the supervisory authorities), who are responsible for issuing the authorizations for those activities taking place in their territories. • the european pharmacopoeia (ep), established on july , by eight countries, aaa is a collection of standardized specifications, so-called monographs, which define the quality reference standard for medicines. today, the convention has been ratified by more than european countries and the eu. european directive / /ec refers to the mandatory character of ep monographs in the preparation of dossiers for maa in the eu. the ep is also applicable in all the signatory states of the convention for the elaboration of an ep, and is used as a reference by many other countries (there are more than observers). the ep is published by the edqm and covers active substances, excipients, substances or preparations for pharmaceutical use of chemical, animal, human or herbal origin, homoeopathic preparations and stocks, antibiotics, as well as dosage forms and containers. the texts of the european pharmacopoeia also apply to biologicals, blood and plasma derivatives, vaccines, and radiopharmaceutical preparations. ▸ nonclinical: all aspects of nonclinical testing and programs are covered under general guidelines (e.g., glp) bbb or discussions on nonclinical strategies to identify and mitigate risks for first-in-human clinical trials or guidelines specific to a type of testing (i.e., pharmacology, aaa belgium, france, germany, italy, luxembourg, the netherlands, switzerland, and the united kingdom. bbb the principles of good laboratory practice define a set of rules and criteria for a quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived. pharmacokinetics, single and repeat dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and local tolerance). most of these guidelines have in fact been developed under the auspices of ich. as for the quality requirements, specific nonclinical guidelines have also been developed for certain types of products. numerous clinical guidelines are available, which cover all phases of clinical development, from early on (i.e., clinical pharmacology and pharmacokinetics studies) to the design of phase studies (disease and patient characteristics, advice on selection of endpoint, duration, control groups, and choice of comparator, etc.). due to the specificities of each group of products, guidelines have been organized by therapeutic area, and some focus on certain types of products (herbal medicinal products or radiopharmaceuticals and diagnostic agents). additionally, general guidelines have also been released to provide advice on general considerations and topics during drug development that are not disease-specific (e.g., "guideline on missing data in confirmatory clinical trials," "extrapolation of results from clinical studies conducted outside europe to the eu population," "clinical trials in small populations," "data monitoring committee," "choice of a non-inferiority margin," and "excipients in the label and package leaflet of medicinal products for human use"). in addition to these numerous scientific guidelines, it is worth mentioning the development and implementation of gcp in europe for investigational medicinal products. this harmonization of gcp has been critical for the recognition of data between european countries, and therefore cooperation on clinical aspects of drug development. directive / /ec is the framework legislation that provides for additional directives, accompanying guidelines, and detailed guidance documents. these guidelines and guidance documents are published in eudralex (volume ). finally, it is important to note that there has been a lot of effort put forth in past years regarding harmonization of the european pharmacovigilance system. this system is coordinated by the ema, but also involves national competent authorities ccc and the european commission. it includes a broad range of activities such as the review of risk management plans (rmps) and psurs, the development and maintenance of the eu reporting and data warehouse system for case reports (eudravigilance), signal-identification activities in the eu, and the coordination of eu rapid alert and incident management systems for timely and adequate responses to new safety data. the eu legal framework of pharmacovigilance was provided in regulation (ec) / and directive / /ec. additionally, relevant ich guidelines have been implemented, and volume of eudralex has been dedicated to this key public health function. it included a number of detailed guidelines, definitions, standards, and information regarding the precise execution of pharmacovigilance-related procedures. ccc in some member states, regional centers are in place under the coordination of the national competent authority. in december , following a public consultation, the ec decided to further harmonize the system (to ensure it is optimally effective, robust, and transparent) via the adoption of two additional texts [ , ] . the final new legislation [ ] was finally published on december , in the official journal of the european union. on june , , the commission implementing regulation (eu) / was adopted, complementing the pharmacovigilance legislation that started to apply in july . finally, some pharmacovigilance incidents in the union have shown the need for further improvements of the legislation. these issues have been addressed by directive / /eu and regulation no / /eu, which started to apply in . due to the number and importance of improvements that need to be implemented [ , ] , many observers consider this new pharmacovigilance legislation as the biggest change to the eu legal framework since the creation of the ema in . the implementation of this new pharmacovigilance legislation required a lot of effort from the ema [ ]. this was a major activity because several processes needed to be established or amended (e.g., the establishment of a new pharmacovigilance risk assessment committee [prac] replacing the chmp pharmacovigilance working party). also, an important change of the new legislation is the increased direct involvement of the ema in the pharmacovigilance of nationally authorized products, in addition to the centrally authorized products. for example, the ema has released the "guidelines on good pharmacovigilance practice (gvp)", which replace volume of eudralex [ ] . this new set of guidelines applies to all medicines authorized in the eu, whether centrally or nationally authorized. the ema is also working with other groups to continuously improve the safety monitoring of medicines. this includes its central coordinating role in protect, ddd its support of the european network of centres for pharmacoepidemiology and pharmacovigilance (encepp), eee its work with the us fda on ae signal detection activities, and its notifications to the who of any measures taken in the eu on medicines that may have a bearing on public health protection in third-world countries. finally, the heads of medicines agencies have also put in place a multi-annual program (called the european risk management strategy [erms] ) which aims to strengthen european pharmacovigilance systems by putting in place efficient measures allowing for the early detection, assessment, minimization, and communication of a medicine's risk throughout its lifecycle. these guidelines apply to more than one specific area and have been prepared through the collaboration of several working parties. they provide advice and guidance on specific ddd protect is a project of the innovative medicines initiative (imi), which is aimed at strengthening the monitoring of the benefits and risks of medicines in europe by developing innovative tools and methods that will enhance the early detection and assessment of adverse reactions. eee encepp is a network that supports independent, post-authorization studies on the safety and benefit/risk aspects of specific medicines. important topics (i.e., pediatrics, cell therapy and tissue engineering, vaccines, biosimilars, gene therapy, and pharmacogenomics). the eu harmonization activities related to certain of these topics are further discussed in the following sections. it is also important to note that cooperation in the areas of inspection (e.g., gmp, glp, gcp, or phv) is critical. although the responsibility for carrying out inspections rests with the national competent authorities of member states, the coordination of these inspections by the ema (and the agreement of common standards) has been an important step that allows for: • increased cooperation between member states • reduced duplication of work (due to the recognition of inspections performed by other member states) • ensuring the same level of quality of medicinal products, and the data generated during their development, wherever the location of the manufacturing site or studies a european system for the authorization of medicinal products has been created with the objective of ensuring that safe, effective, and high-quality medicines can quickly be made available to all citizens across the eu. today, the european system offers several routes for the authorization of medicinal products: ▸ the centralized procedure (laid down in regulation (ec) no / ) is compulsory for certain types of products: products derived from biotechnology processes, advanced therapy medicines, orphan medicines, or products intended for the treatment of certain specific diseases. for medicines that do not fall within these categories (the "mandatory scope"), companies can also submit an application if the medicinal product constitutes a significant therapeutic, scientific, or technical innovation, or if it is in any other respect in the interest of public health. applications for the centralized procedure are made directly to the ema and lead to european marketing authorization. this authorization, binding in all member states, is granted by the ec (based on the opinion of the relevant ema committee). it is valid for the entire community market, which means the medicines may be put on the market in all member states. this is the ultimate integration model in this domain because there is a single application, a single evaluation, and a single authorization allowing direct access to the single market of the community. ▸ the mutual recognition procedure (mrp) (laid down in directive / /ec), applicable to the majority of conventional medicinal products, is based on the principle of recognition of an already existing national marketing authorization by one or more member states. should any member state refuse to recognize the original national authorization on the grounds of potential serious risk to public health, the issue is referred to the cmdh to find a consensus. in that case, the cmdh uses its best efforts to reach an agreement on the action to be taken (within the -day time period foreseen in the legislation). when this fails, the matter is then referred to the ema/chmp for arbitration (see below for details). at the end of the mrp and decentralized procedure, national marketing authorizations are granted in the member states involved, whereas the centralized procedure results in a single marketing authorization (called a "community marketing authorization") that is valid across the eu, as well as in the eea-efta states (iceland, liechtenstein, and norway). purely national authorizations are still available, but are limited to medicinal products to be marketed in one member state only. in addition to the above registration procedures, another european procedure called "referral" has been established. this community referral procedure is used to resolve disagreements (e.g. between member states during an mrp or a decentralized procedure), address specific concerns relating to the safety or efficacy of a medicine or a class of medicines, or when there is a need to harmonize national decisions across the eu. in a referral procedure, the ema is requested to conduct, on behalf of the european community, a scientific assessment of a particular medicine or class of medicines. the problem is "referred" to the chmp so that the committee can make a recommendation for a harmonized position across the eu. referral procedures can be started by the ec, any member state, or by the pharmaceutical company. at the end of the referral, the committee makes a recommendation, and the european commission issues a decision to all member states reflecting the measures to take to implement the chmp recommendation. finally, it is important to note that, in addition to the harmonization of procedures for the authorization of medicines, the system also ensures harmonization and coordination of the pre-and post-authorization activities: ▸ pre-authorization activities: companies can request scientific advice (or protocol assistance in the case of medicines for "orphan" or rare diseases) from the ema at any stage of medicine development, whether the medicine is eligible for the centralized procedure or not. this european procedure helps the company to make sure that it performs the appropriate tests and studies so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing authorization application. ▸ post-authorization regulatory activities (i.e., variations or extensions and transfers of marketing authorizations, renewals, psurs, and notifications) have also been harmonized and are coordinated via the centralized, mrp, or decentralized procedures. this ensures that the same quality, safety, and efficacy of products are maintained during the entire lifecycle management of the products throughout europe (e.g., availability of new formulations, extension of indications, etc.). after years of extensive discussions involving ethical aspects [ ] , the european commission adopted a proposal on september , [ ] . this proposal led to new legislation (regulation (ec) no / ) that entered into force in the eu on january , . today, this amended text (and its several associated guidelines and other published information) [ ] sets up a system of requirements, rewards, and incentives together with lateral measures to ensure that medicines are researched, developed, and authorized to meet the therapeutic needs of children (representing over % of the total european population [ ]). in practice, this new regulation established an expert pediatric committee (pdco) within the ema, which is responsible for providing opinions on the development of medicines for pediatric use. the key objectives of the regulation are: • to ensure high-quality research in the development of medicines for children aged to years of age • to ensure, over time, that the majority of medicines used by children are specifically authorized for such use • to ensure the availability of high-quality information about medicines used by children in , a communication from the ec (communication /c / ) provided guidelines on the format and content of applications for agreement or modification of a pediatric investigational plan. many additional procedural and scientific guidance documents have also been released by the ema to facilitate the implementation of this new regulation. the eu introduced a new orphan medicinal product legislation in in order to provide incentives for the development of medicinal products for rare disorders. harmonization of requirements for these types of products is critical to allow for multinational clinical studies and to limit the development challenges due to the small number of patients. prior to this european legislation, a number of member states had adopted specific measures to increase knowledge on rare diseases and improve their detection, diagnosis, prevention, and treatment. however, these initiatives were few and did not lead to any significant progress in research on rare diseases. procedure for the designation of orphan medicines with the technical committee for orphan medicinal products (comp), which is responsible for the scientific examination of applications. designated orphan medicines are assessed centrally on a european level by the chmp, rather than in each member state separately. this regulation also put in place incentives for the research, marketing, and development of such products (e.g., fee waivers, a -year market exclusivity period postauthorization, and scientific assistance for marketing authorizations). following its entry into force and its associated rules and guidelines, the number of orphan medicines authorized has increased significantly [ ] . this directive's aim is to protect public health while securing the free movement of herbal medicines within the community. while most individual herbal medicines will continue to be licensed nationally by member states, the process for licensing and information on herbal substances and preparations will be increasingly harmonized across the eu. for example, in order to further integrate these special medicines in the european regulatory framework, a committee for herbal medicinal products (hmpc) was established at the ema in september (replacing the cpmp working party on herbal medicinal products). the major tasks of this scientific committee are to establish community monographs for traditional herbal medicines, and to prepare and maintain a list of herbal substances that have been in medicinal use for a sufficient period of time, and so are not considered to be harmful under normal conditions of use [ ] . the procedures for clinical trials in europe used to vary from one country to another. there were different national approaches regarding the approval and notification systems, documentation requirements, and timelines [ ] . in october , in order to coordinate the implementation of the new harmonized requirements across the member states, the hma established the clinical trials facilitation group (ctfg). the ctfg (attended by representatives from the national dras, ec, and the ema) acts as a forum for discussion on the agreement of common principles and processes to be applied throughout europe. it also promotes harmonization of clinical trial assessment decisions and administrative processes across the national dras. this group established a voluntary harmonization procedure (vhp) for the assessment of multinational ctas [ ] . during this three-phase procedure, dras from all member states involved assess the application, though each member state remains ultimately responsible for the approval of the cta in its own country. however, there is a coordinated validation phase (phase ) and voluntary cooperation of the member state during the assessment phase (phase ) before the usual formal national process (phase ). phases and of the procedure are coordinated by a vhp coordinator. the "acceptability statement" obtained through this vhp procedure is then included in the subsequent national cta applications. from march to april , applications were evaluated through the pilot vhp procedure; of these applications received a positive opinion [ ] . the average procedural time was days (which is significantly less than the average time of standard national procedures). the overall feedback from sponsors was positive, except that: directive / /ec and its associated texts and guidelines are a very important step in the harmonization of procedure for the registration and conduct of clinical trials in europe. implementation of this clinical trials directive into national legislation of all eu member states was completed in . principles like clinical trial authorization by the national dras within defined maximum timelines led to significant harmonization of the clinical trial approval process. however, it has been agreed that this new system needs further harmonization in order to achieve the ultimate objective [ ] . indeed, the actual assessment of a request for authorization of a clinical trial is done independently by the member states concerned. the legislation does not provide for a mechanism whereby the member states are obliged to reach a common conclusion regarding a clinical trial involving different member states. this lack of obligation and detailed direction implied different interpretation from member states and therefore created implementation issues. as a consequence, sponsors have to respond to the various required changes and adapt their protocol in view of diverging assessments by the dras. this situation requires additional time and effort by the pharmaceutical industry (without added value for the patients). in , following a public consultation and a long and thorough impact assessment ( the proposal has been submitted to the european parliament and the council who engage in ordinary legislative procedure. this proposal, once adopted by the eu-legislator, is going to replace the clinical trials directive. it is expected to come into effect in and to provide major revisions to the current system (e.g., single assessment outcome, simplified reporting procedures, etc.). finally, it must be noted that other important topics related to the regulation of medicines are also coordinated at the community level (by the ec and the ema) in order to have harmonized regulatory actions and enforcements, and to complete the single pharmaceutical market. these harmonization initiatives are at different stages of development: • to support cooperation and harmonization activities, the eu needed systems and knowledge management support. the implementation of this telematics (the integrated use of telecommunications and informatics) strategy, coordinated by the ema, is critical to increase efficiency and transparency across the european medicines regulatory network. in addition to the standards for electronic submissions (esubmissions) that were developed and published, a central set of pan european systems and databases was created. these systems and databases exchange information with systems of external stakeholders and dras, while staying separate from them. they also help provide high-quality information on medicinal products to the general public and support the monitoring of the post-authorization risk and benefit balance of medicines in the eu. the following critical projects and tools have been developed under this program (some of them are still under development): ▸ eudract: the community's electronic database for clinical trials containing information submitted by sponsors. it informs dras of ongoing clinical trials in all member states and eea countries, enabling an overview of multi-state trials. the system also alerts dras in the case of early interruption or termination. ▸ eudragmp: community database on manufacturing and import authorizations and gmp certificates. the ema launched the first release in april . this system is used by eu gmp inspectors to share information (i.e., gmp authorization, noncompliance with gmp information resulting from inspection activity, planned inspection activity, and "rapid alerts" arising out of faulty manufacture). ▸ eudranet: private electronic network linking the members of the european medicines regulatory network and ema. it ensures that both electronic mail between members of the network and their access to the eu telematics systems is secure. ▸ eudralink: the european medicines regulatory network's secure file transfer system used for exchanging information for regulatory purposes. it operates independently of eudranet, so that it can be used by applicants and marketing authorization holders, as well as the regulatory organizations within the network to transfer files. ▸ eudrapharm: the community's database of authorized medicinal products. some functionalities of this database are still under development. ▸ eudravigilance: system monitoring the post-authorization safety of medicines through safety reports (i.e., suspected adverse reaction reports). it is designed to receive, process, store, and make available information. one of the objectives of this system is the early detection of possible safety signals to facilitate the regulatory decision-making process (based on a broader knowledge of the adverse reaction profile of medicines). the ema to receive, validate, store, and make available information for review marketing authorization applications. the system's key benefit is its ability to take advantage of the lifecycle management functionality built into the ectd by easily allowing the full extent of the current valid documentation as well as its submission history. ▸ eu telematics controlled terms (eutct): central repository and publication system for a controlled term list used in the european medicines regulatory network. the establishment of the eu has not been easy, but it has represented the desire to end conflicts in europe. since its creation, the eu has been successful in delivering peace between member states and has reunited a fractured continent via the promotion of cooperative projects (i.e., economic and social). this cooperative initiative went beyond the initial objectives of its founders. ever deeper integration has been pursued while embracing new members. the membership of the eu has grown from to nations, bringing the eu's population to half a billion people. it has created stable institutions, a single market, and a single currency. despite numerous challenges, ggg the eu has survived, and is today a major economic and commercial power. although improvements are still needed in certain areas, the eu represents a unique model of successful cooperation, harmonization, and integration between countries of different languages, cultures, history, and levels of development. in the pharmaceutical sector, much has been achieved towards the consolidation of the european system of evaluation and supervision of medicines. several challenges have already been overcome, but outstanding issues still need to be resolved to further support and improve public health in europe, free movement and access to medicines in the community, and the competitiveness of the union. taking into consideration its successes and challenges, this section provides a balanced evaluation of the current situation. it demonstrates that harmonization of pharmaceutical regulation in europe can be considered a real and quick success in general (considering the major changes it required), but acknowledges some specific areas where work is still needed. for all these reasons, the development of the eu and its european pharmaceutical "regulation/ system" is a great example that needs to be further evaluated and discussed. although this model of harmonization and integration may not be fully applicable to other cases, this experience can certainly help other regional or global harmonization initiatives. since the adoption of the first pharmaceutical directive in , many topics have been harmonized. the past years have seen a gradual convergence of pharmaceutical legislation in europe. today, a considerable package of harmonized legislation (in the form of the pharmaceutical "acquis communautaire") is in place to support two objectives: the protection of public health and the free movement of products. these provisions/texts applicable to medicinal products are included in eudralex. they include binding legislation (i.e., regulations and directives), but also numerous technical guidelines and recommendations to facilitate the implementation of these common principles. a well-structured european pharmaceutical system has also been established. in addition to the european institutions necessary to harmonize and create the european pharmaceutical legislation, technical european bodies have also been established. today, the evaluation and supervision of medicines in europe is shared between european and national bodies that form a complex but well-organized network of approximately , technical and regulatory experts. words like "networking," "work sharing," and "harmonization" became common and remain crucial for the future. the establishment of the ema as a key coordinator of this system was an important decision for the integration and harmonization of practices and standards to support and promote the single european pharmaceutical market. the primary aim of this centralized system was to create conditions in which a single scientific evaluation of the highest possible standard would lead to rapid access to an integrated market of innovative and good cost-effective treatments. this objective, in large measure, has been achieved. the ema, which is comprised of experts provided by national dras, has today established itself as a leading world agency for the evaluation of medicines. its contribution to the effectiveness and efficiency of the eu system, and therefore to the protection of public health and to the achievement of an operational internal market, is well recognized by all stakeholders. the effectiveness of the system has been maintained despite its growing complexity. indeed, the increase in the number of centralized applications hhh and other procedures, eu enlargement, and new regulations have led to an increased workload and an enlarged scope of responsibility for the ema over the past years. these changes have led to the creation of new committees (comp, pdco, cat, hmpc, prac) that require the implementation of additional procedures and new tools. these structural changes and increased responsibilities should be monitored closely in the future to avoid risks of inconsistencies, overlapping, bureaucracy, and rigidity. also, it is critical to continue to monitor financial compensation of national dras and to regularly assess the involvement of each member state in the eu pharmaceutical system to ensure availability of appropriate resources and expertise [ , ] . within this legal framework and european pharmaceutical system, community authorization procedures (centralized, mrp, or decentralized) have been in place since the mid- s. the centrally coordinated tasks include assessments led by rapporteurs and co-rapporteurs, inspections, and pharmacovigilance through the medicine's lifecycle. although the national dras have prime responsibility for the efficient operation of mrps and decentralized procedures, national marketing authorizations, and clinical trial authorizations for human medicines, the ema has an important role in supporting these noncentralized functions. for example, the ema maintains the eudravigilance database and the eudract database, and supports a range of scientific committees and the coordination group for mrps and decentralized procedures [ ] . the criteria for the approval of medicines and other technical topics have been extensively harmonized within the eu. many technical and regulatory guidelines have been released in all areas (quality, nonclinical, and clinical). there has been a specific focus in recent years to improve the european pharmacovigilance system, to simplify the variation system, to harmonize the requirements for clinical trials, and to implement an advanced therapies regulation. the establishment of the european pharmacopoeia has also been very important to ensure standardization of specifications and quality of medicines in the eu. all these measures and actions described above have led to improved marketing authorization procedures, the harmonization of data protection in the eu, better access to medicines for children, orphan drug development, clinical trials, and a new regulatory framework for advanced therapies. lifecycle management of products has also been improved (i.e., the revised legislation on variations to reduce the administrative burden by streamlining the circumstances obliging industry to file applications). the next review of the european system will be noteworthy because it will evaluate if new measures (developed following the last review in ) improved the system and produced real dividends in terms of cost efficiencies through economy of scale (via the reduction of the administrative burden where this did not have public health implications). it is also worth mentioning that this european system is solid enough to stand the challenges of new therapeutics. the current structure, forum, and processes allow "proactive" harmonization. indeed, most of the harmonization initiatives are created to discuss existing disharmonies on specific topics. at the beginning, the european harmonization effort, related to pharmaceutical regulation, was focused on disharmonies between countries. today, even if disharmonies do still exist on some specific subjects, many topics have been successfully harmonized. the processes and structures that have formed over the years now allow the system to cover new subjects for which no national regulations and requirements have been developed yet. developing this new regulation at the eu level automatically creates harmonized requirements (this can be called "proactive harmonization"). . this group, which included ema staff and members of the chmp and its working parties, generated recommendations on how the ema should tackle these new emerging topics not covered by the existing national, regional, or global regulations and standards. ▸ ema innovation task force (itf): in order to provide support for medicine innovation in the eu, the ema established an internal horizontal cross-sectorial group to focus on emerging therapies and technologies. the itf brings together competences from the areas of quality, safety, efficacy, pharmacovigilance, scientific advice, orphan drugs, and good practices compliance, as well as legal and regulatory affairs. one of the objectives of the itf is to address the impact of emerging therapies and technologies on current scientific and regulatory requirements. its scope also encompasses areas for which there are no established scientific, legal, and regulatory experience. one of their tasks is to identify areas for legal, regulatory, and technical guidance preparation and proposals for consideration by the ema committees and working parties, and to contribute to relevant ec initiatives and legislation [ ] . the eu today is recognized as a major player in the international harmonization of pharmaceutical regulations. it has developed privileged relationships and initiated cooperation projects with other countries outside the european community (major developed countries and emerging markets). for example, the ema cooperates with many of the world's largest regulatory bodies outside the eu iii in areas such as inspections, safety of medicines, and exchange of information on issues of mutual concern. the establishment of the international and european cooperation sector, formed in february and responsible for the development, coordination, and implementation of the agency's international strategy and activities (including confidentiality arrangements with countries outside the eu), demonstrates the ema commitment to international cooperation [ ] . also, collaboration has been initiated with china, india, and russia on pharmaceuticals, and it is partnering with international organizations (i.e., ich, who, and pic/s). this work should continue and also be extended. it is indeed important to support the development of globally harmonized standards and requirements in order to ensure fair competition with other parts of the world for the development of medicines and to avoid delay in the availability of essential medicines for european patients. ensuring against falsified medicines, resolution of pandemic issues, product development in emerging markets, and reliability of clinical data produced outside europe are good examples where international cooperation is necessary to ensure adequate protection of public health in europe. in spite of all the above-mentioned major progress and regular improvement of legislation by the european commission, there is still room to improve the eu pharmaceutical system. on the regulatory side, issues dealing with the implementation and interpretation of community legislation by member states continue to create obstacles to the free movement of medicines. stakeholders continue to raise concerns regarding market fragmentation linked to disparities in national pricing and reimbursement schemes (despite the adoption of directive / /eec in the early days of the european pharmaceutical system), unnecessary regulatory burdens caused by divergences in the implementation of community legislation (e.g., clinical trials requirements), and a lack of commercial interest in national markets that are economically less attractive. european patients still suffer from inequalities in the availability and affordability of medicines. this situation could worsen and create significant inequalities between patients in accessing medicines if it is not resolved. additionally, europe has been losing ground when it comes to innovation and competitiveness in the pharmaceutical market. in its communication of december , [ ] , the ec recognized that further harmonization is necessary to resolve shortcomings in the eu pharmaceutical market in furthering increased globalization of this sector. to improve this issue, the ec confirmed its objective to continue to progress towards a single and sustainable pharmaceuticals market [ ] . to further support and improve the public health in europe and free movement of medicines within the community, and to maintain its competitiveness, the eu needs further harmonization in several areas, such as: novel medicines by patients, mainly due to increased pressure to cut healthcare budgets. in certain countries, medicines are not made available due to administrative requirements and poor economic rewards. a lack of transparency and harmonization with regard to pricing, reimbursement, and relative effectiveness remains a challenge [ ] . in contrast to the benefit-risk assessment carried out by regulators, national hta bodies compare the "relative effectiveness" of medicines and take their financial cost into account. this post-marketing national hta evaluation can lead to national differences due to different country needs. the addition of different requests (i.e., different type of studies) from regulators and hta bodies can also delay availability of new products. to resolve this major issue, the european network for health technology assessment (eunethta) was established to support effective collaboration between national htas. also, the ec gave the political mandate to the ema to begin interacting with hta bodies when it published the conclusions of the pharmaceutical forum in october . kkk since then, the ema has begun to collaborate with national hta bodies and with eunethta [ ] . this interaction focuses on centralized approved products and aims to facilitate communication between ema and hta bodies early in a medicine's development and throughout the medicine's lifecycle. as mentioned above, the harmonization of price and reimbursement evaluation is critical in supporting a european pharmaceutical market. however, it will be a very difficult and long process to implement due to political and budgetary aspects and differences in pharmaceutical markets and healthcare budgets existing between member states. the european clinical trials directive (directive / /ec) has been an important and necessary step in the harmonization of european pharmaceutical regulation. the principles defined in the declaration of helsinki (in ) and the ich gcp e guideline (in ) allowed some harmonization of clinical practices and protection of clinical patients. but, before this directive came into force, the rules for performing clinical trials (i.e., regulatory procedures and requirements) varied significantly in the european community as they were based on differing regulatory approaches in the member states. this new legislation promoted harmonization of clinical trial practices allowing important improvements related to the protection of patients (i.e., safety and ethical concerns) and reliability of data, and facilitated the exchange of information between dras. however, despite this progress, important negative effects of this new legislation have been reported (e.g., the increase in bureaucracy and administrative costs). the number of clinical trials carried out in the eu has fallen by % in recent years, while administrative kkk the pharmaceutical forum was set up in by the european commission as a three-year process in order to find relevant solutions to public health considerations regarding pharmaceuticals, while ensuring the competitiveness of the industry and the sustainability of national health care systems. more specifically, this forum analyzed three key themes: information to patients on pharmaceuticals, pricing and reimbursement policy, and relative effectiveness. costs and delays have doubled [ ] . it is still labor intensive and costly to duplicate largely identical administrative procedures for multinational clinical trials. additionally, sponsors spend a great deal of time retrieving the relevant national information and requirements and preparing customized applications without added value for the patient and the regulators (the core scientific information is the same, but the format and administrative information and forms differ). it is indeed a problem for a large pharmaceutical company, as it usually requires additional dedicated departments with the necessary resources to track differences in national requirements and follow the many parallel procedures. but it is even more problematic for smes or academic sponsors for whom these costs can reach prohibitive levels. this multiplication of parallel procedures also has an important impact on the dras. indeed, available resources are used in multiple assessments of the same core information in different member states, which clearly delays the start of clinical studies. it is important to note that this duplication of assessments does not necessarily increase the quality of the assessment, as the necessary specific expertise might not always be readily available in all the member states concerned. this is a nonefficient use of national resources without added value for the patients or science. this implementation problem is partly due to the legal framework that has been chosen for harmonization in this area. as with all directives, the clinical trials directive had to be transposed in national laws. unfortunately, in this case, the objectives of the directive were transposed into divergent national legislations, somewhat missing the harmonization goal and making multinational trials difficult to perform. in its consultation paper [ ], the ec proposed options to improve the situation. one of the best options is to continue with the harmonization process. this would mean creating a real european system of authorization for clinical trials to avoid duplication of assessment. it would avoid the inconsistent assessment conclusions and requests, encourage appropriate use of resources and expertise (for both the sponsors and dras), and ensure common implementation of the principles laid down in the clinical trials directive. the vhp initiative seems to be a good first step. it allows for a better implementation of the eu clinical trials directive principles and further harmonizes the conduct of clinical trials in europe. however, this procedure cannot be considered as the ultimate solution because it does not resolve all issues [ ] . more specifically: • there are still parallel cta assessments by multiple dras. • there are still major differences between countries regarding the time it takes to issue approval. • this is a voluntary cooperation and there are differences in the level of interest and responsiveness between countries. • the current procedure does not remove specific national requirements or differences between national assessments (this is a cooperation effort, not a harmonization of requirements). • this process does not accelerate the first patient enrolled (fpe) in europe. to resolve these outstanding issues, the current vhp procedure should be revised to become a real mrp where the assessment will be conducted by only one reference member state. the content of the dossier should also be fully harmonized between countries. the establishment of a centralized procedure through a new regulation (which will deliver a pan-eu approval) would also be very helpful for certain types of products that require specific expertise not available in all eu countries (e.g., advanced therapies), for orphan drugs, and/or for pediatric medicines. this centralized process for cta would be a good bridge between the ema scientific advice process and the centralized registration procedure. the system for registration of clinical trials would then mimic the system already in place for the registration of medicinal products with a combination of three types of procedures: • centralized procedure for specific products such as biotechnology and advanced therapies • mutual recognition procedure for other multinational clinical trials • national procedure for a clinical trial involving only one member state this reorganization of the system and procedures, supported by the ec [ ] and most of the shareholders involved in clinical trials [ ] , would utilize the current structures and expertise in europe, would build on the experience acquired with the registration process, and would facilitate patient access to clinical trials and to new technology within the community. it would allow the necessary flexibility and different levels of review for interventional trials (e.g., a small national study with a well-known entity does not need the same type of evaluation, organization, and bureaucracy as a phase study with a new fusion protein or a large multinational phase study). measures should be put in place to ensure that such reorganization would allow this flexibility and avoid any further increase of delay and administrative costs and burdens. for example, "recognition" of other assessments should be the focus, and "nonrecognition" should be limited to major issues (that should be clearly defined). these "nonrecognitions" of assessment by another country should be rare to avoid regular arbitration or appeals that would further delay the start of the clinical studies. selection of reference member states (rms) should also be defined because many parameters are involved in such selection (i.e., expertise, resources, balanced workload between countries, etc.). finally, this new cooperative system should not result in the simple addition of national requirements, but a harmonized scientific assessment that would be implemented equally in all member states. this next step in the harmonization of a clinical trial in europe would certainly be beneficial for patients, sponsors of clinical trials (pharmaceutical companies, but also small entities or academic centers), and dras. some of the above proposals have already been recommended by the european commission [ ] . the recent adoption of a "proposal for a regulation of the european parliament and of the council on clinical trials on medicinal products for human use, and repealing directive / /ec" [ ] by the commission represents an important step in the improvement of the current system. however, this process will take time to implement, and national interests will need to be overcome. finally, the assessments of ethics committees also need to be reviewed and improved. the clinical trials directive is based on the concept of one ethics committee opinion per member state concerned. however, several member states maintain a decentralized system where the single ethics committee opinion is based on the opinion of several local committees. as a consequence, in the eu there are approximately , ethics committees involved in the assessment of clinical trials [ ] . also, better harmonization of responsibilities between dras and ethics committees must happen across europe [ ] . it is agreed that ethical issues fall within the responsibility of member states. however, current practices need to be reviewed in order to smoothly integrate an improved harmonized system and to protect european clinical trials subjects. these programs are important to make new therapies available to patients as soon as possible. they should be handled on a european basis in order to ensure that every european person, wherever their location, has the equal right to access these new medicines at the same time. today, this difference in access within europe is clearly contrary to the overall european objective to ensure that all patients within the community have the same access to the same quality products throughout europe. of course, the harmonization of these requirements and procedures should be carefully implemented to avoid the creation of delays compared to the current situation. ▸ pharmacovigilance: the eu pharmacovigilance system demonstrates that cooperation and harmonization of regulations and practices in europe is beneficial to patients. indeed, merging the eu national pharmacovigilance systems into one network increases the quantity of data/reports/ information, which facilitates the early detection of possible safety signals, and therefore the monitoring of product safety. unfortunately, the mediator issue in france has shown that the eu pharmacovigilance system needs to be improved to be fully functional. this topic has been one priority of the european network. the ongoing implementation of the new legislation by the ema and the member states will be critical. although the mutual recognition and decentralized procedures have improved over time, challenges still exist, and the principle of these procedures (i.e., recognition of another country's assessment) is not always respected. in both these procedures, member states can only refuse to recognize other countries' assessments if they feel that this recognition could have a "potential serious risk to public health." unfortunately, this reason for disagreement is vague enough to allow flexibility for member states. in , a guideline was released [ ] to further clarify how this risk should be defined. however, some national dras continue to have a broad interpretation of "potential serious risk to public health," and trigger ema arbitrations for grounds that do not fall under this specific category [ , ] . in addition to the specific issues discussed above, more general challenges can also impact the harmonization of european pharmaceutical regulation. although these general considerations are not specific to the pharmaceutical sector, they can influence the establishment and implementation of pharmaceutical regulation. therefore, they need to be understood and integrated when developing implementation plans and timelines: • . this major difference in workload between countries demonstrates a big gap in work sharing and certainly highlights differences in national dras' expertise and resources and pharmaceutical companies' interests for each national market. • one of the complexities and difficulties of the eu system is the division of activities undertaken at the national level (e.g., clinical trial responsibility, scientific advice handling, etc.) and at the eu level (e.g., equal scientific advice handling, assessment of pediatric investigational plans, etc.). this requires many communications and infrastructures between the eu and national players. • external economic or political factors could also influence the harmonization of european pharmaceutical regulation. for example, the modification of european borders via new enlargement of the eu (even if the eu leaders have agreed to mark a pause for now, discussion on the accession of countries such as turkey, iceland, and serbia are still ongoing). additionally, the possible creation of a "mediterranean union" desired by past french president sarkozy could also impact the scope and timelines of the next steps of harmonization and integration. finally, it will be important to see if and how the two new functions created by the treaty of lisbon (president of the eu council and high representative of the union for foreign affairs and security policy) will benefit the eu. the first important dossiers after the creation of these two functions (global financial crisis, global security, and support to greece) have indeed still been handled by the political leaders of major member states (i.e., france and germany). it is clear that the european system is integrally linked to its own history. this model cannot fully fit every harmonization initiative in the world because every situation and need is different. however, it is worth reviewing the lessons learned from this plus years old initiative. this first regional harmonization initiative (rhi) overcame a lot of challenges, and has since developed into a strong regional harmonized pharmaceutical regulation and system. this success demonstrates that an organized cooperation and harmonization can facilitate the development of high standards and practices. more specifically, the european initiative clearly demonstrates that a structured stepwise approach is necessary: ▸ first, it is necessary to set up major principles (directive / /eec). ▸ second, it is critical to provide specific detailed requirements and to further detail the agreed principles (directives / /eec, / /eec, etc.). ▸ third, a structured and organized system is needed to implement the principles and requirements. technical bodies need to be established to control medicines and manage the establishment of common procedures (especially centralized types). in europe, it was key that the national dras provide expertise and resources to european bodies not only to ensure appropriate availability of resources, but also to ensure full adhesion of the countries into the system and adequate communication between all players of the system (national and european). ▸ when all the basic principles and a system are in place, additional more specific requirements can be discussed so that the system can take into account particular needs (i.e., specific requirements for specific products, population, etc.) in order to have a more coherent system. ▸ finally, it very important to monitor the system and regularly review the extent to which this system and measures support the harmonization goals and meet the predefined objectives. evolution of the environmental impact (i.e., globalization, change of membership, change of political commitment, and need for new requirements due to emerging problems, etc.) also has to be taken into consideration, and the regulation and system needs to be carefully adjusted to ensure its longevity. another lesson learned from europe is the importance of cooperation. to be successful and ensure effective functioning of this system, cooperation between the different entities of the system (ema, hma, national dras, ec) has been, and remains, critical. even if the european pharmaceutical system is complex, it is well organized. the provision by the member states of high-quality scientific resources for the evaluation and supervision of medicines is a critical factor for the success of the eu system. indeed, scientific excellence (as a result of eu-wide pooling of expertise and data) has been a key strength. in this respect, it should be stressed once again that such excellent progress has been highly dependent on close collaboration between the ema and the national dras within the context of the eu regulatory network, and in particular on the valuable input of high-quality specialist expertise provided by the member states. this provision of national resources, coordinated by the ema, is one of the features of the eu regulatory network. this success also relies on political support for this european harmonization initiative in order to support the creation of the single market. without this political commitment (and therefore associated funds and resources), it would have certainly been much more difficult and taken more time to create this system. it is recognized that other harmonization initiatives in the world are certainly suffering from the lack of such political commitment, especially when such harmonization is not driven by the willingness to create a single market (i.e., integration model). finally, the eu has also clearly demonstrated that better organization at the regional level is extremely critical to ensuring the success of global harmonization and cooperation. even if all regions are not working towards integration like europe, this example of better coordination and representation should be followed and discussed in other regions of the world. indeed, this example demonstrates that a well-organized and coordinated regional structure is beneficial to all stakeholders [ ]: ▸ individual countries via better representation and better access to international activities/agreements/decisions through regional structure (this is especially true for small countries with less expertise and resources). individual countries also benefit from the infrastructure (i.e., databases or training programs) and good practices developed at the regional level. ▸ regions because they allow better representation of interests (europe has more power than a combination of small countries' voices, and has an impressive network of experts). ▸ international cooperation and harmonization initiatives because they facilitate communication by reducing the number of contacts and seats at the international level (but provide a structure for dissemination of information). for example, having all eu countries represented at ich would not be possible. this regional coordination is very important for the future of global initiatives (such as ich or who projects), but it is even more important in the management of a worldwide health crisis (e.g., pandemic influenza). this european coordination system should be implemented in other regions of the world because the coordination of rapid and efficient communication of information and actions during such a crisis helps the overall coordination of the situation. for example, in the recent case of pandemic influenza, it was critical to have central coordination (not only global, but regional). the ema (using its "crisis management plan") allowed europe to respond rapidly and efficiently to the challenges of an outbreak of pandemic influenza by: ▸ the fast-track review of vaccines (using its best experts) ▸ monitoring the safety of centrally authorized pandemic-influenza vaccines and antiviral medicines ▸ liaising and coordinating activities with critical partners, including the ec, eu member states, other european agencies (such as the european centre for disease prevention and control), and international partners (such as who and regulatory bodies of non-eu countries) to ensure timely exchange of information and coordination of activities relating to the pandemic ▸ coordinating the communication of relevant information to the public, healthcare professionals, and the media all of these activities would be less efficient if performed by each individual country. political and economic development in the pan-american region has resulted in interest in regional economic integration. several subregional integration groups have emerged in this area since the s. harmonization of pharmaceutical regulations and technical standards is a component of this economic integration, but the degree of progress in this area varies a lot from one subregion to another (and even from one country to another). in light of these various economic integration initiatives, the need became evident for an entity in which the different countries of the region could share experiences and expertise. the pan-american network for drug regulatory harmonization (pandrh) was created in november . this is a regional initiative established to promote drug regulatory harmonization throughout the pan-american region within the framework of national and subregional health policies. this continental forum is not a supranational entity, and its decisions represent recommendations to be assimilated into the subregional integration initiatives. the mission of this network is "to promote the harmonization of pharmaceutical regulation covering aspects of quality, safety, efficacy and rational use of pharmaceutical products, the strengthening of national regulatory authorities (nra) capacity within the region of the americas based on the right of the population to access quality medicines, recognizing advances in science and technology and within the context of national and sub-regional realities" [ ] . the objective of this initiative is to facilitate regional harmonization of medicinal drug requirements and guidelines for specific regulatory issues. this objective is achieved by adopting recommendations for implementation at national and regional levels, and also by supporting the development of training on specific important topics. however, this initiative also has broader objectives such as: ▸ promoting and maintaining a constructive dialogue among dras, the pharmaceutical industry, and other sectors ▸ strengthening the dras of the region ▸ encouraging convergence of drug regulatory systems in the pan-american region ▸ facilitating technical cooperation among countries in collaboration with subregional integration groups. since , pandrh has been a member of the ich global cooperation group (gcg). this membership broadens pandrh's role because this regional harmonization initiative is now also involved in global harmonization. pandrh provides a way to disseminate recommendations on drug regulatory harmonization of global initiatives. it also ensures that regional specificities and challenges will be considered when new global recommendations are discussed. ▸ dras of all pan american health organization (paho) member states ▸ regional pharmaceutical industry associations: latin american association of pharmaceutical industry (alifar) and latin american federation of the pharmaceutical industry (fifarma). ▸ academia ▸ consumer groups and professional associations it also includes representatives from the five subregional trade integration groups within the americas (plate ) that are themselves multinational cooperation initiatives but are working on a broader integration with emphasis on political and/or financial interest: ▸ the andean community is a community established in (by the cartagena agreement) that currently regroups four countries (bolivia, colombia, ecuador, and peru). chile and venezuela have also been part of this initiative in the past and some others countries are observers. these countries decided voluntarily to join together for the purpose of achieving more rapid, better-balanced, and more autonomous development through andean, south american, and latin american integration. they also created a free trade area (including the four current members plus venezuela). this integration initiative is broad and regroups several areas, one of them being health. the integration of health is governed by the andean health body, which coordinates the actions aimed at improving the healthcare of member countries. it gives priority to cooperative mechanisms that promote the development of subregional supranational systems and methodologies. these actions are also coordinated with the other subregional, regional, and international organizations. discussions include many topics such as the development of a pharmaceutical policy model, the evaluation of medicinal products, and a surveillance network. ▸ sica (the central american integration system) is the institutional framework of subregional integration in central america. this is the latest step of a long integration process in the region. it was created in december (by the signing of the tegucigalpa protocol) by the states of belize, costa rica, el salvador, guatemala, honduras, nicaragua, and panama. this initiative also involves the dominican republic as an associated state and some regional and extra-regional observers (mexico, chile, brazil, china, spain, and germany). the headquarters of the general secretariat is located in el salvador. the first objective of this integration process in central america was to transform the area into a region of peace, liberty, democracy, and development, based firmly on the respect, tutelage, and promotion of human rights (following a history of political crisis, conflict, and dictatorial rule in the region). health topics are covered by the executive secretariat of the council of ministers of health in central america (se-comisca). several projects are under discussion in this subregion, such as the basis for quality assurance of drugs and a pharmacovigilance system. ▸ mercosur (the "common market of the south") was created in (by the signature of the treaty of asuncion) and encompasses five latin american countries (argentina, brazil, paraguay [which is currently suspended], uruguay, and venezuela). the purpose of this agreement was to set up a common market and eliminate trade barriers among the signatory parties. mercosur has been involved in several health projects (such as implementation of gmps with training and joint inspections and development of programs on vaccine regulation and control) to promote cooperation between its members and harmonization of specific pharmaceutical regulations in this subregion. to date, there is no mutual recognition system. ▸ nafta (north american free trade agreement) was implemented in january to remove most barriers to trade and investment among the us, canada, and mexico. the objective of this agreement was to establish procedures to facilitate trade and investment on the north american continent. this trade liberalization had some positive impact and created one of the largest trade blocs in the world, but some downsides have also been reported by economists (who have shown that nafta has not been able to produce an economic convergence). nafta has had a minor impact on the harmonization of pharmaceutical regulations in the region and has not been able to resolve the problem of parallel import of pharmaceutical products between canada and the us. one of the major components of this initiative is the pan-american conferences on drug regulatory harmonization held every two to three years. these conferences are the highest instance of the pandrh network. they serve to define priority areas for harmonization and to endorse standards, guidelines, and other recommendations, including norms and procedures and steering committee membership. they also provide a forum for discussing issues of common interest in drug regulation. participants include all interested parties such as the dras of all paho member states, representatives of the regional pharmaceutical industry associations, academia, consumer groups, professional associations, and representatives from the five subregional trade integration groups within the americas. the st pandrh conference took place in november (in washington, dc, us). pan-drh was then officially created during the nd pandrh conference in november (also in washington, dc). following these first two conferences, subsequent conferences took place to review ongoing activities of the working groups. pandrh mimics the ich structure. it is organized around three major bodies: ▸ the steering committee (sc), which ensures operational management of this initiative between conferences, is composed of: • seven members from five national dras (one from each of the subregional economic groups) and two industry representatives (fifarma and alifar) • seven alternate members from five different national dras (one from each of the subregional economic groups) and two industry representatives (fifarma and lifar) • regulators from other countries (not represented on the sc), representatives from nongovernmental organizations (ngos) recognized by paho/who, and other stakeholders invited by the sc who may also participate in sc meetings as observers members of the committee serve for a period of four years, with staggered rotation to maintain continuity. the sc meets at least twice every year. its primary role is ( ) to establish the agenda for the biennial pan-american conferences, and ( ) to follow up on conference recommendations by establishing and monitoring the progress of working groups. the responsibility of this group is to promote progress between conferences through the coordination, promotion, facilitation, and monitoring of the harmonization activities. ▸ the technical working groups are specifically formed to work on topics and areas identified for harmonization. the members are experts in their specific subject matter. a working group may include the following categories of members: • main members that represent the national dra of a country in each of the five subregional blocs, the regional industry associations alifar and fifarma, and those designated by the secretariat • alternate members designated to attend the meetings instead of the principal members • observers from any country generally nominated by a participating national dra (the observers do not retain voting rights) • expert resources (as needed) to support a specific activity of the group (expert resources do not have voting rights) the national dras of countries not represented in the working group can designate focal points to follow the activity of the group. each working group has a coordinator (and an alternate) who chairs and coordinates the meetings, leads the development of documents, and reports periodically to the sc on the progress of the group. in general, the first task of a new working group is to conduct a survey to identify the differences in regulatory requirements among countries in order to prepare a work plan. then, the group reviews international and regional and/or national recommendations and guidelines and prepares a harmonized proposal. when the harmonized standard is developed, the working group is in charge of designing training and helping in implementation of this standard by assisting countries in the dissemination and education concerning this new rule. technical working groups meet in conjunction with sc meetings or separately (determined by a work plan and resources). ▸ a secretariat, provided by paho, supports the initiative technically and administratively. it monitors the pandrh website, serves as a focal point for the coordination and dissemination of information, coordinates activities arising from recommendations of the conferences and sc, and acts as liaison and a representative of the network in global and interregional harmonization organizations (icdras, ich, etc.) as in other regions of the world, there is a need to promote harmonization of pharmaceutical regulations to facilitate the availability of safe, effective, and good-quality products and thereby protect public health. paho initiated communication among the different members of the pharmaceutical sector in the americas in order to facilitate communication among the different subregional blocs (and also the countries not already covered by these blocs) and organize regional harmonization. the first pan-american conference took place in november (in washington, dc, us). this conference was considered the first step towards the establishment of pandrh. during this first conference, the scope and the term "harmonization" were defined (as the search for common ground within the framework of recognized standards, taking into account the existence of different political, health, and legislative realities among the countries of the region). the structure and financial support of pandrh were also discussed at this first conference. however, pandrh was officially created during the nd conference (november in washington, dc) following a consultation in caracas, venezuela in january , and also several ad hoc discussions and meetings (meeting of americas' regulators in washington, dc in november , regional working group on bioequivalence in caracas in january , and regional working group on gcp in buenos aires in may ). during this second conference, the mission statement and objectives of the sc were agreed upon. this initiative was then officially recognized by the nd directing council of the paho in september . resolution cd .r , which was approved during this council, provided strong support from ministers of health of the member states in the region to pandrh and to the process of drug regulatory harmonization. during pandrh conference v (in buenos aires in november ), the regulations governing pandrh (mission, structures, and procedures) that were originally created during the nd conference were slightly modified to incorporate lessons learned during its first few years of establishment [ ]. harmonization proposals are developed by the technical working groups. these groups primarily use who documents as the basis for developing regional guidelines. other international guidelines including ich and selected regional (e.g., eu, american subregional) or national technical documents are also used as the basis for harmonization proposals and as reference materials. after a working group has agreed on a draft harmonized document, it is posted on the website for external comment. comments are reviewed by the working group to prepare the final version of the document that will be presented for adoption by the conferences through the sc. conclusions and recommendations of the conferences are to be adopted by consensus (if consensus cannot be reached, the different points of view have to be recorded). during its seventh meeting (in june in washington, dc, us), the sc established a system of phases and stages for its harmonization process. this system, which mimics the ich process, is composed of five phases, with each having substages: final technical documents are intended for use at the national level (through the subregional integration groups), but this implementation is at the discretion of each country. members of the sc are responsible for monitoring implementation in their subregion. pandrh is also discussing strategies to follow up the implementation of its recommendations at the national and subregional levels. in addition to the biennial pan american conferences on drug regulatory harmonization that allow for communication and exchange, pandrh is also committed to training all interested parties (including regulators and industry). such training covers major topics such as gmp inspection, gcp, glp, bioequivalence, etc. the initial priorities that the pandrh defined during the first conference were gmp (to facilitate the implementation of gmp in the region and ultimately to develop mechanisms for mutual recognition of inspection), bioequivalence, and gcp. additional topics were then added, each of these considered critical in the development of the network and in the protection of public health in all concerned countries. currently, there are areas of priority that have been selected by pandrh (for which working groups have been established): several recommendations developed so far are based on who recommendations. for example, who report was the basis for the discussion on gmps, and the who and ich guidelines were used to build consensus on gcps. most of the selected topics are technical and have been chosen in order to ensure the quality, safety, and efficacy of the products approved, and that these products are adequately promoted and maintained. the work on drug classification is also key to ensuring a common language and facilitating subsequent harmonization discussions. combat against drug counterfeiting has also been selected, as this is a major issue in this region directly affecting public health in all countries and requiring a multidisciplinary, multi-sectorial, and crossborder perspective. finally, the activity on drug registration is a broader project, and is very important for ensuring implementation of pandrh recommendations and for reaching full harmonization of pharmaceutical regulations. this is critical in ultimately developing a collaborative regional or subregional registration process and system and sharing of expertise and resources between countries. this group drafted a proposed list of harmonized requirements for drug registration in the americas [ ] . the current list of selected topics above will certainly be amended in the future if new emerging topics (creating potential health public issues in several countries of the region) need to be discussed and resolved at a regional level. for example, the working group on biotechnological products has been established following a roundtable session of the th pandrh conference. this roundtable session was organized to discuss biotechnological products (and also the specific issue of biosimilars). biosimilars present a clear risk for the patient (if they are not well controlled), but also a major opportunity for increased access to cheaper essential medicines (if they are well regulated). these biotechnological/biologic products have unique technical challenges that require technical and specific expertise. pandrh will have to work on this topic collaboratively with who, which has already released recommendations on this topic. pandrh's scope of harmonization and cooperation includes technical guidelines, regulatory processes, and the strengthening of national dras through harmonization of processes and standards to improve and assure drug quality. by adopting its recommendations and standards, countries in this region can clearly improve the quality of their regulatory system and provide access to quality, safe, and effective drugs. moreover, pandrh plays an important role in the global harmonization of pharmaceutical regulations. it is an important link between global organizations/forums and the regions. through its involvement in the ich gcg, it increases: ▸ the integration of the regional challenges/priorities/vision in the development of international standards ▸ the implementation of such international standards in the region this regional initiative is one of the most difficult to operate because it includes very different regulatory systems and structures (from the most developed system such as the us fda to the most undeveloped countries in the world). this initiative also has to take into account the existence of very different political, health, and legislative realities among the countries that correspond to very different priorities, interests, and resources. this reality creates difficulties in the management of projects and the establishment of consensus [ ] . however, this disadvantage also provides opportunities and benefits as the most developed dras can help to mentor the less developed ones. recognizing preexisting asymmetries in the region, pandrh has become a forum to discuss common issues on drug regulation and share knowledge and expertise. not all the countries are involved in actually developing the proposals, but all of them participate in the decision of adopting them via the conferences. by promoting the collaboration of experts from different countries/subregions, and also from both the public sector (authorities and academia) and private sector (industry), pandrh has developed quality recommendations (frequently based on who or other international reports and recommendations). it must be noted that pandrh is clearly dependent on paho/who. without this support and investment, pandrh would certainly not be viable. indeed, this financial, technical, and administrative support from paho/who, which represents an important recognition (both in and outside the region), is critical for the following reasons: ▸ as for all such multinational initiatives, one of the challenges of pandrh is funding. pandrh's budget is primarily supported by paho, but additional funds also come from governments, the pharmaceutical industry, international organizations, and registration fees from training courses. ▸ resources from involved countries are limited. paho, by providing a secretariat, has structured this initiative and allows the practical development of the harmonization projects. ▸ who provides critical technical help for the preparation of pandrh recommendations. most pandrh guidelines and documents are indeed based on who reports. the th conference of pandrh, held in july (which included over participants from countries), focused its discussions on the theme "strengthening national health regulatory authorities." several working groups presented the conclusions of their work and their recommendations and actions. the topics also addressed during this conference included the role of pandrh as coordinator of international cooperation, paho's recognition of national regulatory reference authorities (anmat-argentina, anvisa-brazil, invima-colombia, and cecmed-cuba), implementation of the pandrh guidelines in the subregions, and innovative activities of the national dras in surveillance or in treatment compliance. this conference concluded with the approval of a strategic orientations document. the main recommendations were aimed at developing more effective cooperation among countries to guarantee, inter alia, the adoption and implementation of the different technical documents produced. the major challenges for the future (what pandrh will be assessed on) is the implementation of both its own and ich's recommendations. this will determine if this initiative delivers on its promises and if the countries that form this initiative are committed to this harmonization. because dras of all countries in the region participate in the conferences, it is expected that recommendations and guidelines will be adopted and implemented by the individual countries and incorporated in the discussion at subregional economic groups. however, it may not always be so straightforward/automatic, and the implementation of its recommendations may become one of the major challenges of this regional initiative because its members have no obligation to implement harmonized standards. the decision to develop a - pandrh strategic plan to guide future development of the network, and ensure flexibility, scientific rigor, and representation of all stakeholders in the network [ ], will certainly strengthen this initiative. the gulf cooperation council (gcc), also known as the cooperation council for the arab states of the gulf (ccasg) is a political and economic union. established in , this trade bloc comprises six arab states of the arab gulf. it represents one of the wealthiest country groupings in the world due to its extensive oil and gas reserves. its population is approximately million and its gross domestic product (gdp) is estimated at approximately us $ billion [ ] . the gcc has been active in political affairs outside its territory. due to the instability of the middle east region, the gcc has been heavily involved in diplomatic discussions to solve the different conflicts and problems of the region (i.e., iraq/iran war, iraqi invasion of kuwait, iraqi situation after the breakdown of the former regime, israeli/palestinian war, etc.). the objectives are to avoid the expansion of war and eliminate violence and terrorism in the region in order to support regional development and modernization. in order to achieve unity, the gcc promotes the coordination, integration, and interconnection between its member states in various fields. one of the first objectives of the gcc is to formulate similar regulations in different areas, including health. cooperation and coordination in health are under the responsibility of the council of the gcc health ministers (chm). under its oversight, the gulf central committee for drug registration (gcc-dr) was established to provide gulf states with safe and effective medicines at a reasonable cost. this committee works towards this objective by promoting cooperation and harmonization among member states. this initiative covers prescription, nonprescription, generics, and biologics. on the international side, the gcc represents the region at the ich global cooperation group (gcg). the current gcc members are six arab states of the arab gulf (plate ): bahrain, kuwait, oman, qatar, saudi arabia, and the united arab emirates (uae). iran and iraq are currently excluded although both nations have a coastline on the persian gulf. yemen is currently not part of the union. this country is, however, involved in some gcc initiatives (i.e., activities related to the health sector) in view of a future accession. for example, yemen is a member of the council of the gcc health ministers (chm). the supreme council is the highest authority of the gcc and is formed by the heads of the member states. presidency of the gcc supreme council rotates, and it convenes annually in a regular session, though additional extraordinary sessions may also be scheduled. this supreme council is supported by the ministerial council, composed of the ministers of foreign affairs of member states or other ministers acting on their behalf. the ministerial council proposes policies, lays out recommendations, and coordinates existing activities in all fields. resolutions adopted by other ministerial committees are referred to the ministerial council, which in turn refers relevant matters to the supreme council for approval. the chm is the highest regional level of authority in the area of health. it consists of health ministers from each of the gcc member states (plus yemen, though presently not a member). it meets for two to three days twice a year, and these meetings are open to all regulators from the gcc member states and yemen. who (via its regional office for the eastern mediterranean, emro) also attends as an observer. the chm is supported by an executive board to whom an executive office general director reports. the executive office is located in riyadh, saudi arabia. at the working level, a gcc-dr was established to oversee the different activities in the pharmaceutical sector. the steering committee of the gcc-dr is composed of two members from each of the member states (including yemen), and meets at least four times per year. the membership is limited to government agencies or dras. the executive office also appoints two of its affiliates as advisors (nonvoting members) to the steering committee. this committee is responsible for the registration of the pharmaceutical companies and their products as well as for the preparation of technical regulations and guidelines. to develop a new guideline, the gcc-dr steering committee uses the resources of the member states by assigning the drafting of the specific guideline to either a single member state or several member states. technical working groups can also be set up to help in developing the guideline. within the executive office, a permanent gcc-dr secretariat was also created to support the organization. the role of this secretariat is to facilitate the harmonization activities through administration, coordination, and communication. it is also responsible for receiving and reviewing registration files for completeness and for preparing steering committee meeting agendas. the gcc was created on may , , and its unified economic agreement was signed by its member states on november , in riyadh, saudi arabia. the primary objective was to achieve "coordination, integration and interconnection between member states in all fields in order to achieve unity between them" [ ] . this integration plan was developed in detail during the first years following the establishment of the gcc. on december , , the gcc supreme council adopted, during its nd session in muscat, oman, a revised economic agreement that accelerated this integration. this revised agreement enhanced and strengthened economic ties and increased harmonization among member states. in chapter ii, the agreement defined specific areas that needed to be harmonized in order to support the gcc common market, health being one of these areas. article also promotes joint projects and adoption of integrated policies between member states. having finally completed all requirements, the gcc common market was declared in december and came into force as of january . this launch of the common market removed barriers to cross-country investment and service trade. gcc cooperation in the health sector began in the mid- s when the gcc health ministers held informal meetings such as the one held in geneva (may , ) during the general assembly of who. such cooperation was then formalized with the establishment of the conference of the health ministers of the arab countries in the gulf, which held its first meeting in february . since , it has been called chm. as mentioned previously, under the chm, the gcc-dr was established in to provide the gulf states with safe and effective medicines. the scope of the gcc-dr's harmonization and cooperation efforts in the pharmaceutical sector covers technical guidelines and regulatory processes. this includes the registration of pharmaceutical companies and products as well as good manufacturing practice (gmp) inspection. under the oversight of the chm, the gcc-dr steering committee is responsible for the selection and prioritization of topics, the assignment of the development of guidelines and policies, and the subsequent review and approval of the resulting recommendations. when a new topic is selected for harmonization, the gcc-dr steering committee assigns the development of the guideline/policy to either a single member state or several member states, and a technical working group is then established. the membership of this working group is at the discretion of the assigned member state(s). it may include regulatory, industry, and academic experts. technical working groups meet regularly (independently of the steering committee meetings). an annual meeting is also held with both the steering committee and relevant invited experts to discuss policy and regulations. ich guidelines are often used as reference material when developing gcc-dr guidelines. other international guidelines (including who recommendations), available national technical documents, and guidelines from other regions (e.g., eu) are also used. once developed by a working group, the draft guideline is posted on the gcc and the saudi food & drug authority (sfda) websites (http://www.sgh.org.sa and http://www.sfda.gov.sa/ en/pages/default.aspx). they are also circulated to all member states for comment. at the end of the consultation period, the working group reviews all comments received, finalizes the document, and proposes its adoption by the gcc-dr steering committee. following its adoption, the general director of the executive office submits the guideline to the chm for final approval. gcc-dr steering committee members are responsible for monitoring the implementation of the adopted guidelines in their countries. each country reports whether it encounters any problems in implementing the guidelines during an annual meeting where the gcc-dr activities are evaluated. standard practices and operating procedures have been developed to govern all steps of the harmonization process (i.e., selection and prioritization of topics, solicitation of comments, approval/ implementation of guidelines and responsibilities of the different bodies, as well as funding). additional procedures also cover the process in place for the registration of products and companies. the gcc-dr is financed by member states (using established quotas of contributions) and by registration fees. the status of its activities is communicated through its website, and also through presentations at national and international meetings, workshops, and conferences. although the executive office organizes gmp training, there is currently no official structured training program within this initiative. each member state is responsible for providing training to their regulators. the gcc-dr has initiated work on several general topics related to the development and registration of all medicinal products (gmp and gmp inspection, bioequivalence studies, stability, good laboratory practice [glp] , and clinical trials). the group also decided to harmonize practices on post-marketing activities via the development of guidelines on post-marketing surveillance (covering the counterfeiting problem) and pharmacovigilance. finally, recommendations on specific types of products (biosimilars, sera and anti-venom, vaccines, and blood products) are also under discussion. the guidelines listed above are at different stages of development (under discussion, drafting in progress, approved, or implemented). they are all based on ich, who, us fda, and/or ema recommendations. in addition to these guidelines, the gcc-dr also established a common central procedure for the registration of both the pharmaceutical companies and the pharmaceutical products. the establishment of a common system of registration and control of medicines was discussed at the first meeting of the chm in . this subject was a recurrent topic of discussion until actual implementation of this procedure in . since its implementation, the registration of both medicines and pharmaceutical companies has slowly transitioned from the national to the gcc registration procedure as shown in the table . under this procedure, dossiers (including fees) are submitted to the gcc-dr secretariat. each country reviews the dossiers and forwards its recommendations to the gcc-dr steering committee. the committee's resolutions are adopted by the majority of the attendant members' votes (four countries is the minimum that must be represented). gmp inspection and analysis of samples by the accredited laboratories are also part of this central procedure. after the central approval, each country must adopt this central approval nationally. as mentioned above, the gcc-dr is responsible for gmp inspections, but also for the approval of quality control laboratories and for the review of technical and post-marketing surveillance reports. all these central activities increase the harmonization and integration of the pharmaceutical sector. since its creation and the signing of its initial unified economic agreement in , the gcc has cooperated in many different fields (i.e., political, military, security, legal, economic, environment, and health) and developed common policies in support of achieving full integration. this integration goal was reemphasized in when the gcc supreme council adopted a revised economic agreement. in january , the launch of the gcc common market marked an important step in the gcc's integration. in the health sector, cooperation began earlier. before the signature of the unified economic agreement in , the health ministers had decided to cooperate in the area of health. since the initial discussions by the health ministers, many objectives have been fulfilled. the development of common guidelines, cooperation in the domain of gmps, and the establishment of a central registration procedure for companies and products are certainly the major achievements from this group. the unified purchase of drugs (i.e., common tenders concept) is also one of the most important achievements of the chm. it has ensured the purchasing of high-quality registered products from registered companies (national or international) for a more affordable price as it increased the amount of products purchased. but it has also ensured the use of the same products by all member states, which is indeed an important step in the integration process and the creation of the common market. this cooperation allows the member countries to implement common drug policies and adopt an efficient drug quality surveillance reporting system to monitor the efficacy and safety of the registered drugs [ ] . recognizing all the above achievements, and despite clear increases in cooperation, the gcc has, however, not yet fully achieved its goal of unity in the pharmaceutical sector. indeed, this group has selected an integration model that will require stronger ties between countries. for example, the central registration procedure still involves national reviews and is longer than the national registration [ ] . moreover, approvals delivered via this central procedure still have to be adopted by each member country. this integration process is not as advanced as in europe, where there is a rapporteur that conducts the review of the application on behalf of the group and where the ec approves drugs on behalf of all european countries. harmonization of the regulation (via both regional integration and international cooperation) is critical for this region for the following two reasons: ▸ first, this region is highly dependent on medicines developed and manufactured in other countries and regions. even if pharmaceutical companies (both international and regional) are increasing their investment in the middle east region, this region is still primarily an import-oriented market. all gcc countries share the same characteristic of being high importers of pharmaceutical products. more than % and % of pharmaceuticals consumed in oman and saudi arabia, respectively, are imported [ ] . it is critical for the region to ensure that products from other countries have been developed and manufactured following acceptable standards and requirements. ▸ second, we have seen that most of the gcc-dr recommendations and guidelines are based on other international work (i.e., ich, who, etc.). the gcc is therefore dependent on the resources and expertise of these international organizations to develop its own state-of-the-art requirements and standards. the next step in the integration process of the gcc region will certainly be a better and bigger sharing of resources and expertise. the challenges of this next step will be the development of an organization and infrastructure to support such evolution. today, the regulatory expertise in the different countries is varied, with saudi arabia being the leader in the region. this country represents the biggest pharmaceutical market of the region, with approximately % of the pharmaceutical sales of the gcc [ ], and its regulatory system is recognized as the most developed of the region. in , the regulatory agency in saudi arabia, the sfda, employed people in its drug sector with approximately reviewers, compared to less than in most of the other gcc countries. the ongoing development of a common and central system needs to ensure that the less developed countries of the regions will benefit from this cooperation without impacting the more developed countries in this sector. another challenge for this group, like for all other harmonization initiatives, is the implementation of the agreed-upon standards. the gcc needs to work on measures, including the development of a structured training program, to facilitate the implementation and follow-up of recommendations. today, the southern african development community (sadc) is comprised of southern africa states, and its headquarters are located in gaborone, botswana. each of the sadc member states is at varied stages of socio-economic development, but are predominantly underdeveloped. its aggregated gross domestic product (gdp) is approximately us $ billion, with south africa representing a significant portion of this amount. its estimated total population is approximately million [ ] , with an average population growth rate of . % and an average fertility rate of . births per woman of childbearing age. approximately % of this population lacks sustainable access to affordable and quality essential medicines. the average life expectancy is . years (the lowest in the world) [ ] . the sadc objectives (listed in article of the sadc treaty) support regional integration and increased economic, social, and political cooperation in order to promote peace and security, economic growth, well being of the population, and protection of the environment and natural resources of the region. to achieve this major and broad objective, the sadc has launched projects and defined specific actions (e.g., harmonization of policies and creation of appropriate institutions and mechanisms). additionally, the sadc has had major milestones, such as the formation of the sadc free trade area (fta) in , and set future goals, including the establishment of the common market by and the creation of a single currency by . the first achievement related to the formation of the sadc fta took place on august , at sandton, south africa during the th summit of sadc heads of state and government. acknowledging that regional cooperation was critical to addressing the health problems of the region, the sadc decided to include health in its program of action. the need for harmonization of registration and control of medicines was further justified in when the disparities of legal systems and levels of development affected the implementation of a regional bulk purchasing initiative (involving five medicines used to treat tuberculosis) [ ] . the sadc health program was developed taking into account global and regional health declarations and targets. to enhance this regional health integration within a legally enforceable framework, a protocol on health matters was developed. sadc also has access to the international network because it is part of the ich global cooperation group (gcg). the the summit, comprising all the heads and/or governments of sadc member states, is the highest regional authority and therefore the supreme policymaking institution of sadc. it is responsible for the overall direction and control of the community. its structure and functions are enumerated in article of the sadc treaty. the summit usually meets in the member state holding the deputy chairpersonship of sadc at the time (additional meetings can also be held if necessary). the main objective of the organ on politics, defense and security, under the oversight of the summit, is to promote peace and security in the region. the structure, operations, and functions of the organ are regulated by the protocol on politics, defense, and security cooperation, which was approved and signed by the summit at its meeting in august in blantyre, malawi. since , the sadc leadership has been based on the troika system, which includes the chair, incoming chair, and the outgoing chair of sadc (other member states may be co-opted into the troika if necessary). the troika represents the summit between annual meetings and makes quick decisions on behalf of sadc that are ordinarily made during the summit meetings. this system allows the organization to execute tasks and implement decisions expeditiously. it also allows the provision of policy direction to sadc programs and operations between regular sadc meetings. this troika system is applied at the summit level, but is also applicable for the organ on politics, defense and security, the council, the integrated committee of ministers, and the standing committee of officials. to support the sadc activities, a central secretariat was formed. this body is defined as the principal executive institution of sadc responsible for the coordination of the harmonization of policies and strategies to accelerate regional integration. it is responsible for the management of sadc meetings, and financial and general administration. it is also involved in strategic planning, management of sadc programs, and the implementation of decisions of sadc policy organs and institutions. one of the characteristics of the sadc is its emphasis on a decentralized institutional arrangement ( figure ) . following previous negative experiences and failures in regional discussions, the founder states agreed that member states should be the principal players in the formulation and implementation of policy decisions. therefore in addition to the central sadc institutions, sadc national committees were established by the sadc treaty. these sadc institutions at the national level are present in each member state and include key stakeholders from government, the private sector, and civil society. their functions are ( ) to provide national feedback and input in regional strategy and planning, and ( ) to ensure the proper implementation of these agreed-upon regional strategies, protocols, and programs at the national level. this southern african union was created in by nine founding member states (angola, botswana, lesotho, malawi, mozambique, swaziland, united republic of tanzania, zambia, and zimbabwe) with the adoption of the lusaka declaration on april , in lusaka, zambia. at that time, this alliance was called the southern african development coordination conference, and its main objective was to coordinate development projects in order to lessen economic dependence on south africa, then under apartheid. the formation of this alliance was the culmination of a long process of consultations begun in the s when it became clear to the leaders of the founder countries that the improvement of living standards would require regional cooperation. this cooperation was directed initially towards the political liberation of the region. following the decolonization and the political independence of southern african countries, and acknowledging the poverty and economic problems of the region, the leaders of these countries saw the promotion of economic and social development through cooperation/integration as the next logical step. on august , (in windhoek, namibia) , a new declaration and treaty was signed during the summit of heads of state and government. article of the treaty gave a legal basis to the organization and promoted it from a coordinating conference into a development community. the sadc was then established to spearhead economic integration of southern africa. this strengthening of the integration process in southern africa was aligned with the overall african continental efforts to promote closer economic relations (as defined in the treaty signed in to establish the african economic community). in march , sadc country heads of state and governments met in windhoek, namibia. during this extraordinary summit, many important decisions were made that triggered an amendment to the sadc treaty. first, the summit decided to restructure sadc institutions and to establish sadc national committees in order to facilitate the implementation of a more coherent and better-coordinated strategy. the extraordinary summit also approved the preparation of the risdp by the secretariat. the purpose of this -year plan (which was adopted in august and launched in march ) was clearly to deepen regional integration by providing sadc member states with a consistent and comprehensive program of long-term economic and social policies. this plan reemphasizes the major objectives of the organization, reviews the socio-economic indicators and challenges of the region, and analyzes all the important domains for the integration process (including health). it also provides objectives and specific targets for priority intervention areas, and specifies plans and timeframes for implementation and monitoring of its important measures. for example, in the health domain, the plan proposes to coordinate, harmonize, and monitor the implementation of regional policies and to standardize the qualification and accreditation systems. the cooperation in the health domain started in with the development of the sadc health program. three key policy documents were important in the implementation of this sadc health program: as defined in article of the sadc treaty, protocols were established in each area of cooperation. these protocols spell out the objectives and scope of, and institutional mechanisms for, cooperation and integration. each protocol (which is approved by the summit and is registered with the secretariat of the united nations organization and the commission of the african union) is binding for the member states that are party to the protocol. more than protocols have been developed in all domains of integration. the protocol on health [ ] covers all aspects related to health (from the control of major communicable and noncommunicable diseases to the health laboratory service and institutional mechanisms). article states that member states should cooperate in the harmonization of procedures for pharmaceuticals, quality assurance, and registration, and also in the production, procurement, and distribution of affordable essential drugs. the implementation plan of this protocol (which further defines and prioritizes the actions to facilitate implementation of the protocol) fixes the integration of regional regulatory processes and the establishment of a mutual recognition as a - past, present, and future milestone [ ] . in line with the sadc health protocol, a pharmaceutical program was developed to address issues related to the access to quality medicines in all member states. this program was approved in june . this sadc pharmaceutical harmonization initiative and cooperative activities include the development of technical guidelines and policies relating to the registration and control of medicines across the sadc member states. the initiative aims to improve the quality, safety, and efficacy of medicines circulating within the region, and to establish and maintain a regional shared network system for dras. the ich and who guidelines, as well as other guidelines, form the basis as reference materials for the development of regional guidelines, with agreement on the adoption of international guidelines whenever possible. potential topics for harmonization are identified at the level of the subcommittee of ministers of health, often with the input of senior ministerial health officials and mra forum experts. the process of harmonization is initiated through the sadc secretariat, which prepares and submits for decision an agenda to the ministers of health. within this context, the sadc pharmaceutical business plan was released in june . this - plan identified priority areas, objectives, and major activities that needed to be implemented both at regional and national levels to improve access to quality and affordable essential medicines (including african traditional medicines). for example, strengthening regulatory capacity (and ensuring that fully functional dras are in place with an adequate enforcement infrastructure) and facilitation of the trade in pharmaceuticals within the regions were key strategies developed in the plan. the monitoring and ongoing evaluation of this plan (its implementation was estimated at us $ million) was also described (see figure , which explains the relationship between the different players of the plan). under the oversight of the ministers of health, a group of designated senior officials monitored the implementation of the plan via the establishment of technical subcommittees or task teams. this group of senior officials (from the health departments of each member state) was also supported by the secretariat. the sector of the secretariat responsible for supporting the operations of the pharmaceutical harmonization initiative takes place under the directorate of the shd&sp. national health ministries also play a significant role (by coordinating and leading the implementation of programs at the national level), and report on progress through their sadc national committees. finally, other stakeholders (e.g., professional associations, research institutions, dras, etc.) are also involved and requested to provide expertise and feedback on specific actions of the plan. in , the medicines regulatory forum was created as a technical subcommittee to promote the harmonization and enhancement of the pharmaceutical regulations in the region. this standalone committee is made of the heads of the national regulatory bodies. the sadc has released guidelines on several topics. these guidelines regulate the following general areas: ▸ the conduct of clinical trials: these guidelines provide a framework (information to be submitted, review process, etc.) and refer to the entire ich gcp (this is not a replacement or subimplementation of the ich gcp). ▸ registration of medicines: "guidelines for submitting applications for registration of a medicine" were released in . an application form is also available. ▸ good manufacturing practices. ▸ pharmacovigilance (only basic rules are provided). ▸ advertising. ▸ recalls. ▸ registration of nutritional supplements, vaccines, and traditional medicines. ▸ bioavailability and bioequivalence. ▸ stability studies. ▸ import/export (with an emphasize on gmp). most of the above guidelines are based on, or cross-reference, ich and who guidelines and recommendations. these international bodies provide much of the technical assistance to sadc initiatives. when they exist, national rules and requirements are also used (e.g., the gcp requirements from south africa). guidelines have also been developed to cover the following topics that are of specific interest for the region: ▸ pharmaceutical wholesale ▸ hiv vaccine clinical trials ▸ donations of pharmaceutical products it should be noted that the sadc efforts in the pharmaceutical area include african traditional medicines. these products are an important part of the healthcare environment of these countries. one of the cooperation projects is to establish a regional databank of traditional medicines and medicinal plants, and to develop regional policies and legal frameworks for the practice of these traditional medicines. finally, sadc is trying to establish a joint procurement system and to harmonize standard treatment guidelines/lists among countries. these two actions will facilitate the use of the same medicines within the region and therefore allow further harmonization of the pharmaceutical environment. since its inception in april , sadc has demonstrated that regional cooperation and integration is possible and useful for southern africa. one of the foremost achievements of sadc has been to put in place a regional program (the sadc programme of action) with numerous projects covering cooperation in various economic sectors. the formation of the sadc fta on august , was an important first step in this ongoing integration process. the overall and ultimate goal of sadc is integration by ; this is a very ambitious plan. presently, the level of cooperation varies for each area. in some areas, this cooperation only aims to coordinate national activities and policies. in others, the cooperation goes towards real integration. for example, on foreign policy, the main objective is coordination and cooperation, but in terms of trade and economic policy, a tighter coordination is in progress with a view to one day establishing a common market with common regulatory institutions. in the health and pharmaceutical domain, many harmonization projects have been established despite challenges. indeed, as recognized in the sadc pharmaceutical business plan, the region has many weaknesses, such as weak regulatory systems (leading to many unregistered products), lack of adequate capacity and trained personnel, outdated medicine and intellectual property laws, and noncompliance to gmp (leading to inadequate availability of medicines and poor and inconsistent quality of these medicines in some member states). even if there is a political will, it is very difficult for the authorities of this region to resolve this situation as they are confronted by two major problems: ▸ the management of major diseases (such as hiv/aids, tuberculosis, malaria, etc.) ▸ the lack of adequate resources and finances to support all health initiatives the combination of the two above problems, common to all developing countries, slows down the development of other health activities. all the efforts and resources in the domain of health are rightfully dedicated to the prevention and treatment of the major public health concerns. activities such as the development of adequate regulatory function and framework or the development and harmonization of pharmaceutical requirements are therefore negatively impacted. even if all sadc member states have national medicine policies, legislation, and regulation in place, some of these policies have been draft documents for many years (up to years). a number of the laws date back from the s (some even to the s). it is clear that such policies and legislation need revisions to include recent developments and meet current standards in public health and medicines. such revisions and updates would help the implementation of the sadc harmonized recommendations and guidelines. however, despite the numerous weaknesses and problems that the region faces, the sadc was able to promote cooperation between member states in order to improve access to quality medicines. there have been several major accomplishments in the development and harmonization of pharmaceutical requirements, such as the development of pharmaceutical guidelines for the registration and control of medicines, the establishment of the pharmaceutical business plan, and the establishment of the "medicines regulatory forum." moreover, the sadc has now analyzed (with its pharmaceutical business plan) the weaknesses, opportunities, and overall priorities in the pharmaceutical domain (i.e., regulation and control of medicines). the road map includes the assessment and strengthening of dras (work performed in collaboration with the who), combat against the spread of counterfeit medicines, the development of regional training programs, and the establishment of accredited quality control (qc) laboratories. to support this road map and other areas of harmonization, the structure of the sadc institution will certainly have to be modified (as done in the past). in order to be successful, sadc will also need to continue to work with external organizations. support and technical assistance from ich and who will continue to be critical. but, communication and cooperation with other groups and regions (e.g., the new partnership for africa's development [nepad]) will also be necessary to coordinate the efforts on the entire continent and share the available resources, financial support, and expertise. this is especially important because some sadc members are also part of other african subregional initiatives. finally, the next important phase for sadc is the implementation of the agreed-upon standards, recommendations, and plans (e.g., how will the proposed actions to "strengthen national dra capacity to implement harmonized sadc guidelines" be managed?). implementation is a challenge for all harmonization initiatives. this is especially true for this region due to all the weaknesses carried by these countries and the lack of resources and finances. however, the lack of appropriate regulations in some countries may paradoxically become an opportunity; the coordination of the development of the regulation (based on the who and ich recommendations) can be viewed as an a priori harmonization. moreover, it is interesting to note that the sadc structure presents a specificity not found in other harmonization initiatives. in addition to the standard centralized bodies (i.e., summit, council of ministers, committee of senior officials, central secretariat, etc.), the sadc has established national committees. these national sadc contact points could become critical for this implementation phase. this unusual model may also be useful for other worldwide initiatives. the association of southeast asian nations (asean), established in , has very broad objectives. the aims and purposes of the association, stated in its declaration, include: ▸ the acceleration of economic growth, social progress, and cultural development in the region through joint endeavors in the spirit of equality and partnership in order to strengthen the foundation for a prosperous and peaceful community of southeast asian nations ▸ to promote regional peace and stability through abiding respect for justice and the rule of law in the relationship among countries in the region ▸ to promote active collaboration and mutual assistance on matters of common interest in the economic, social, cultural, technical, scientific, and administrative fields ▸ to provide assistance to each other in the form of training and research facilities in the educational, professional, technical, and administrative spheres ▸ to maintain close and beneficial cooperation with existing international and regional organizations with similar aims and purposes, and explore all avenues for even closer cooperation among them the asean region has a population of approximately million, a total area of . million square kilometers, a combined gross domestic product (gdp) of us $ , billion, and a total trade of about us $ , billion [ ] . its estimated annual pharmaceutical imports and exports is us $ . billion [ ] . among the three pillars of the asean community (political-security, economic, and socio-cultural) agreed upon by the asean leaders in the declaration of asean concord ii (signed on october , in bali, indonesia), the establishment of a single market by is an important goal. its objective is to allow the creation of a stable and prosperous asean economic region in which there is a free flow of goods, services, and investments in order to reduce poverty and socio-economic disparities. at the th asean summit in january , the leaders affirmed their strong commitment to accelerate the establishment of an asean economic community (aec) by and signed the cebu declaration on the acceleration of the establishment of an asean community by . in , in moving towards this ultimate goal, asean launched the asean free trade area (afta) and defined priorities (e.g., healthcare) where regional integration should be accelerated. one of the basic criteria to support afta, and ultimately a single market, is the harmonization of standards and regulations. therefore, recognizing the importance of the harmonization of standards to facilitate and liberalize trade and investment in the region, asean has established the asean consultative committee on standards and quality (accsq) to harmonize national standards with international standards and implement mutual recognition arrangements on conformity assessment to achieve its end goal of "one standard, one test, accepted everywhere." the accsq monitors the harmonization of standards and regulations in many different areas (i.e., pharmaceutical products, but also cosmetics, medical devices, food, electrical and electronic equipment, automotive products, wood-based products, etc.). harmonization in the pharmaceutical area is coordinated by the pharmaceutical product working group (ppwg). the objective of this group is to harmonize the technical procedures and requirements applicable to the asean pharmaceutical industry in the region, taking into account other regional and international developments on pharmaceuticals. since , asean has been a member of the ich global cooperation group (gcg). this membership helps asean to become an important component in the global harmonization process, as it constitutes a way to disseminate the ich recommendations on drug regulatory harmonization. it also ensures that asean specificities and challenges will be considered when new global recommendations are discussed. the the highest decision-making body of asean is the meeting of the asean heads of state and government (the asean summit) that is convened annually. additional ministerial meetings are also held regularly. committees of senior officials, technical working groups, and task forces have been created to support the asean summit and ministerial meetings and conduct the agreed asean activities. the accsq was established to coordinate the harmonization of national standards with international standards. this committee reports to the asean senior economic official meeting (seom) that is under the supervision of the asean economic ministers (aem). the ppwg, under the supervision of the accsq, was created to coordinate the harmonization activities related to the pharmaceutical area. the scope of activities of the ppwg includes the following: ▸ exchange information on the existing pharmaceutical requirements and regulations implemented by each asean member country. ▸ review and prepare comparative studies of the requirements and regulations. ▸ review the harmonized procedures and regulatory systems currently implemented in others regions in order to develop harmonized standards, regulations, and procedures for the region. for each specific topic selected for harmonization, the ppwg sets up ad hoc committees and assigns one of the member states as the project leader. membership of the ad hoc committee is on a voluntary basis. the core members of the ppwg are the chair and co-chair, representatives from the dras from each asean member state, a representative from the asean secretariat, as well as representatives from pharmaceutical industry associations. delegates from additional member states can also participate in ppwg meetings as observers. in addition, accsq members and invited experts may attend the annual ppwg meeting. the ad hoc committee meets prior to the ppwg meetings. additionally, the ppwg operates through self-sponsorship (i.e., each member state is responsible for its own funding for traveling or hosting meetings). who has also contributed to the process in the past. ppwg activities are supported by the asean secretariat, which was established on feburary , to coordinate the asean branches and to implement asean projects and activities. in , the mandate of the asean secretary-general was enlarged to initiate, advise, coordinate, and implement the agreed-upon asean activities. finally, it should be noted that another working group, the asean working group on pharmaceuticals development (awgpd) (under the supervision of the asean health ministers meetings), also participates in the regional harmonization of pharmaceutical regulations through its activities on traditional medicines, good manufacturing practices (gmps), good clinical practices (gcps), counterfeiting drugs, and pharmacovigilance [ ] . asean was officially established with the signature of its declaration (the bangkok declaration) on august , in bangkok, thailand by the five original member countries (i.e., indonesia, malaysia, philippines, singapore, and thailand). brunei darussalam joined on january , , vietnam on july , , laos and myanmar on july , , and cambodia on april , . the accsq was formed in to facilitate and complement the afta. efforts towards specific harmonization of pharmaceutical regulations have been initiated by the accsq since . the pharmaceutical product working group was then established in september in kuala lumpur, malaysia following a decision by the accsq during its th meeting (march in manila) . during its inaugural meeting during september - , , the ppwg formulated its terms of reference and set up a work plan (i.e., goals, strategy, activities, expected output, and status). subsequent meetings focused on the status review of ongoing harmonization activities, and discussion and adoptions of final recommendations. the asean also decided to develop relationships with other countries. they developed "bilateral agreements" with a number of countries (canada, india, the us, the russian federation, pakistan, etc.), other regions (europe, gcc, sadc, andean group, mercosur), and international organizations (united nations, unesco). but one of the most important developments was the creation of the "asean plus three" cooperation to promote the east asia region. this cooperation began in december with the convening of an informal summit among asean leaders and their counterparts from east asia, namely china, japan, and the republic of korea. it was then formalized in with the issuance of a joint statement on east asia cooperation at the rd asean plus three summit in manila, philippines. the asean plus three leaders expressed confidence in further strengthening and deepening east asia cooperation at various levels and areas, particularly in economic, social, political, and other fields. public health and harmonization of standards are topics under discussion among others. several bilateral economic arrangements have already been signed, and may be the basis for the possible establishment of an east asia free trade area in the future [ ] . in november , two important documents were ratified: ▸ first, the asean charter which spells out the principles to which all member states adhere to was signed. this legal framework, which entered into force on december , , serves as a firm foundation in formulating the asean community by providing legal status and an institutional framework for asean. it also codifies asean norms, rules, and values, sets clear targets for asean, and presents accountability and compliance. ▸ second, the asean leaders also signed the declaration on the asean economic community (aec) blueprint that provides the elimination of forms of nontariff measures and market access limitations in order to transform asean into a single market. the draft guidelines developed by the ad hoc committees are reviewed, discussed, and then adopted, by consensus, during the ppwg meeting. these standards are then endorsed by the accsq. the ppwg harmonization process includes the following steps: ▸ exchange and review of information on existing pharmaceutical requirements and regulations of the member states. ▸ compare the requirements and regulations to identify key areas for harmonization. ▸ create an ad hoc committee (and assignment of a lead country) to prepare the draft "harmonized product," which most of the time is based on guidelines or recommendations already available (in one of the asean countries, internationally, or in another regions). ▸ circulate the draft to all member states for comments. ▸ consolidate comments into the revised draft. ▸ discuss and adopt (by consensus agreement) the draft by the ppwg. ▸ endorsement of the document and recommendation by the accsq. ▸ dissemination of the adopted documents (via the asean website or seminars/ meetings). ▸ compulsory implementation of the recommendation by the member states. in order to organize, coordinate, and monitor the implementation of the agreed-upon recommendations and guidelines, the ppwg set up a specific task force and working group to focus on a mutual recognition arrangement (mra) and implementation. they developed a standard operating procedure (sop) and plan of action. they also assessed the status of the implementation of requirements (i.e., adoption into the national systems) in order to develop appropriate training (to government and industry) to increase understanding of the asean guidelines and fill the gaps among the member states. the first project of the asean ppwg was to compare the existing product registration requirements for pharmaceuticals of asean member countries in order to help define key areas for harmonization. this report was finalized in . following this assessment, the group developed the asean common technical requirements (actrs) for pharmaceutical product registration in the asean region. these requirements are sometimes based on the existing national requirements, who guidelines and recommendations from other regions (e.g. the asean guidelines for "the conduct of bioavailability and bioequivalence studies" were created from the ema/cpmp note for guidance). but most of the asean actrs have been developed via the adoption or modification of the ich guidelines. they cover all the quality, nonclinical, and clinical aspects already developed by ich. labeling requirements, administrative data (i.e., certificate of pharmaceutical product (cpp), letter of authorization, application forms, etc.), and the glossary have also been discussed. the final actrs were endorsed by the accsq at its st meeting (in march ) . guidelines to actr (e.g., process validation and stability) have also been developed. the group also developed an asean common technical dossier (actd) for pharmaceutical product registration. like the ich ctd, this initiative reduces the time and resources needed to compile applications for registration in different countries. regulatory reviews and communication with the applicant is also facilitated by a standard document of common elements. this actd is based on the ich ctd, but is organized into four parts only (the overview and summaries are included at the beginning of the relevant parts i, ii, and iii instead of being grouped under a separate section as in module of the ich ctd): ▸ part i: activities have also been conducted in the area of gmps. on april , , the asean economic ministers (at the th asean summit and related summits in pattaya, thailand) signed the asean mra for gmp inspection of manufacturers of medicines. this arrangement establishes the mutual recognition of gmp certifications and/or inspection reports (issued by inspection bodies) that will be used as the basis for regulatory actions such as granting of licenses and supporting post-marketing assessment of conformity of these products. the ppwg also worked on a bioavailability/bioequivalence study reporting format and a post-market alert system. the objective of the asean post-marketing alert system is to share information relating to defective or unsafe medicines, and also cosmetics, health supplements, and traditional medicines. this pilot project was launched in april and then adopted by the ppwg in february . the two major accomplishments of the ppwg are the actd and the atcrs. the actd is the common format for marketing authorization application dossiers, while the atcrs are the set of written materials intended to guide applicants to prepare application dossiers in a manner that is consistent with the expectations of all asean dras. a series of guidelines for the implementation of the atcrs is being finalized. most of the asean recommendations strictly follow the ich guidelines and recommendations. indeed, asean is a good example of the influence of the ich outside the ich regions and of the integration and implementation of ich standards outside ich frontiers. beyond these harmonized technical aspects of the pharmaceutical product registration that need to continue, the ultimate goal of the asean ppwg is clearly to implement a system where countries fully cooperate in enhancing mutual regulatory capacities and resources. with the ongoing challenges posed by the globalized economy, and in particular the huge economic growth of china and india, which may have specific impacts on the region, this association of countries is clearly committed to full integration (with the goal to establish an asean economic community by ) and moving towards the european community model. the ultimate steps in the pharmaceutical harmonization process will certainly be the development of asean pharmaceutical directives, the development of a pan-asean registration process (with a centralized procedure), and the establishment of an asean regulatory agency. but the full implementation of this supranational system will take time. it will only be possible when the asean has developed common legislation and structure (i.e., commission, parliament, etc.), as in europe. the harmonization of pharmaceutical regulations can, however, continue before such an organization is in place. the next logical step is the creation of an mra procedure. indeed, this type of procedure is not binding for the countries (and therefore does not require common legislation) and requests only a "facilitator body" and not a supranational evaluation agency. this procedure would be similar to the old "multi-state" procedure that europe established in as a first step towards the creation of the system that we know today. asean is also committed to increased relations with external partners. the creation of the asean plus three cooperation may indeed promote the harmonization of pharmaceutical regulations in the much broader asia region. outside the region, asean and its ppwg clearly want to increase relationships and cooperation with other regional organizations, and also international bodies (i.e., un, who, ich). this development, which is outside its current framework, could indeed strengthen this initiative by increasing its exposure on an international basis, therefore allowing this organization to play a pivotal role in the international community. the asia-pacific economic cooperation (apec) is a forum, established in , to facilitate economic growth, cooperation, trade, and investment in the asia-pacific region. this region accounts for approximately % of the world's population, approximately % of world gross domestic product (gdp), and about % of world trade [ ] . since its creation, this intergovernmental grouping has worked to reduce tariffs and other trade barriers across the asia-pacific region in order to liberalize trade and investment and facilitate business within the region. apec also works to create an environment for the safe and efficient movement of goods, services, and people across borders in the region through policy alignment and economic and technical cooperation. to support its "three pillars" (i.e., trade and investment liberalization, business facilitation, and economic and technical cooperation), apec has been active in a broad range of more than topics (from fisheries, agriculture, and tourism to terrorism, finance, and intellectual property). this broad range of topics, under which hundreds of specific projects have been developed, reflects the complex factors and issues related to economic development, growth, and the pursuit of open trade and investment for a region. several of these topics can influence the health and pharmaceutical sector (such as intellectual property or science and technology), but two specifically focus on this area: ▸ the health topic, managed by the "health working group," focuses mainly on the prevention and management of infectious diseases (naturally occurring or due to bioterrorism) in the region. this working group is not involved in the discussion related to pharmaceutical regulation. ▸ the life sciences topic, managed by the life sciences innovation forum (lsif), addresses key challenges in the health and pharmaceutical sector in order to create the right policy environment for life sciences innovation. the harmonization of standards and the regional and international cooperation are two of the tools used to achieve the objectives. as a member of the ich global cooperation group (gcg) since , apec lsif promotes the implementation of the ich guidelines through its workshops. it also keeps ich informed on the status of the different ongoing initiatives in the region. apec has member economies from the broad asia-pacific region, which spans four continents (plate the members of apec recognize that strong economies and harmonization initiatives are not built by governments alone, but by partnerships between government and its key stakeholders, including industry, academia, research institutions, and interest groups within the community. therefore, apec actively involves these key stakeholders in the work of the forum. at the working level, representatives from the private sector are invited to join many apec working and expert groups. this process provides an important opportunity for industry to provide direct input into apec's ongoing work. apec has official observers, the association of southeast asian nations (asean) secretariat being one of them. these observers participate in apec meetings and have full access to documents and information. apec operates as a cooperative, multilateral economic, and trade forum. apec policy direction is provided by apec leaders from the member economies. the life sciences innovation forum (lsif), under the committee on trade and investment, is a tripartite forum involving representatives from government and academia, and also from industry. it brings together scientific, health, trade, economic, and financial considerations to create the right policy environment for life sciences innovation. all the apec activities are supported by the apec secretariat, which is based in singapore and operates as the core support mechanism for the apec process. it provides coordination, technical, and advisory support, as well as information management, communication, and public outreach services. the idea of apec as a cooperative to enhance economic growth and prosperity, and to strengthen the asia-pacific community, was first publicly mentioned by the former prime minister of australia (bob hawke) during a speech in seoul, south korea in january . later that year, asia-pacific economies met in canberra, australia to establish apec. in november , apec's vision was reiterated by apec economic leaders during their meeting in bogor, indonesia. during this meeting, the economic leaders adopted what are referred to as the "bogor goals." these goals of "free and open trade and investment in asia-pacific no later than " were based on a recognition of the growing interdependence of the economically diverse region, which comprises developed, newly industrializing, and developing economies. due to the heterogeneity of the region, it was agreed that the pace of implementation would take into account differing levels of economic development among apec economies. in , a framework for meeting the bogor goals (referred to as "the osaka action agenda") was adopted. this action plan focused on three key areas: ▸ trade and investment liberalization ▸ business facilitation ▸ economic and technical cooperation following this first action plan, several other plans have been adopted over the years to support the implementation of the bogor goals. specific topics (such as climate change and severe acute respiratory syndrome [sars]) were also discussed. recognizing the global financial crisis as one of the most serious economic challenges ever faced, the leaders highlighted the importance of reducing the gap between developed and developing members. this meeting included discussions related to regional economic challenges (implementing a structural reform and food supply and price), the social dimension of globalization, the enhancement of human security in the region, and the problem of climate change. the lsif and the health working group held their first joint meeting in march in washington, dc, us to explore possible areas of cooperation. this meeting followed the recommendations of the apec senior official endorsing a new terms of reference for the steering committee on economic and technical cooperation. it was then agreed that the role and operations of the health working group would be reviewed with a view to merge, disband, or reorient this body. the lsif leads the activities related to the regulatory convergence in the pharmaceutical area within the asia-pacific region. both apec and the lsif have recognized the benefits of convergence related to the pharmaceutical standards within the region. to achieve this goal, these two groups rely on other regional and global harmonization initiatives. indeed, the lsif is working towards the adoption and implementation of existing harmonized international guidance and regulatory best practices. it also provides the ability to access funds to advance projects. unlike asean, the objective is not to proactively develop specific regional harmonized guidance. this practice is in line with the overall apec goals to facilitate cooperation and trade in the region, and to operate on the basis of nonbinding commitments and open dialogue. as already mentioned, apec has no treaty obligations required of its participants, and there is no plan for integration (unlike asean, which follows an integration model like europe). recognizing this specific context, the objective of lsif is "regulatory convergence" with gradual alignment over time between member economies. the distinction with "regulatory harmonization" is that "regulatory convergence" does not typically involve or require active harmonization of regulations that would be unrealistic within the apec environment. the objectives and priorities of the lsif, listed in its strategic plan approved by the apec ministers in , are very broad. this plan includes recommendations on four different sectors: research, development, manufacturing and marketing, and health services. the goal was to develop recommendations that would contribute to a more efficient, effective, and coordinated policy approach to support innovation and health in the region. these recommendations have applications in many different areas (legal, finance, scientific, regulatory, infrastructures, etc.). one of the recommendations from this strategic plan follows: "harmonization of standards for life sciences products and services and mechanisms for collaboration and exchange of information among economies were recognized as critical elements" [ ] . the principle was to review policies, standards, and regulatory mechanisms against international best practices in order to move towards regional convergence. the objective was also to achieve close collaboration and to facilitate the use of international standards and global best practices through collaboration with outside bodies such as the ich gcg. the lsif has been very active in sponsoring a series of workshops on anti-counterfeiting, ich quality guidance, clinical trials, and good clinical practice (gcp) inspection. however, it has been recognized that the lsif has not been used to its full potential to promote regulatory convergence and cooperation compared to some other rhis [ ] . what was missing was the engagement of regulators and the appropriate industry people in this equation, together with the lack of a more focused strategic framework and multiyear plan for medical products. in / , acknowledging the lack of strategic and effective approaches, the lsif decided to react and strengthen its organization: ▸ in june , the lsif took an important step towards harmonization by establishing, in seoul, south korea, the apec harmonization center (ahc). this followed a proposal from south korea in august (at the apec lsif vi in lima, peru) that was endorsed by the apec leaders in november in a joint ministerial statement. as an lsif organization, this center has its own structure (including a director, a secretariat, and an advisory board of lsif experts), and also its own website (www.apec-ahc.org). this organization includes representatives from government, industry, and academia. its mandate is to provide a platform to address and solve priority concerns of apec members on regulatory convergence. following the establishment of the ahc, several workshops took place. in general, they focused on the regional regulatory convergence, but also discussed specific problems such as multiregional clinical trials and the biosimilar concept. the purpose of these workshops is to allow government, regulators, academics, and the pharmaceutical companies to discuss and exchange information and views on the harmonization of standards. funding and support from the ahc has allowed for the delivery of more than a dozen workshops since june . ▸ in addition to the ahc, apec also decided to establish a regulatory harmonization steering committee (rhsc) within the lsif structure to strategically coordinate regulatory convergence in the region. the rhsc brought together senior officials from regulatory authorities and representatives from industry coalitions. this committee provides leadership and direction on regulatory priorities. during its inaugural meeting in seoul, south korea in june , the rhsc discussed and finalized its terms of reference and started to identify priority projects. since then, the rhsc has initiated several projects and developed a strategic framework on regulatory convergence of medical products by to coordinate activities [ ] . since the creation of the apec ahc and rhsc, considerable progress has been made with the design, development, and implementation of a more strategic, coordinated, and sustainable approach. this includes the strategic framework and the creation of priority work areas (pwas), each of which is associated with a roadmap that defines an overall strategy to achieve the ultimate goal of greater regulatory convergence by in the area of medical products. each project or activity undertaken must now support the roadmap and in turn move apec closer to the goal. this is a better-structured organization that moves away from individual, uncoordinated activities and workshops to a more directed, coordinated approach with parties and individuals that are in a position to effect change and commit resources. the workshops, organized and funded by the ahc and led by the rhsc membership, are now tied to a directed roadmap and strategic framework representing the collective efforts and commitment of many economies. these workshops served as a diagnostic of issues, challenges, and opportunities associated with a particular area of focus, with recommendations coming back to the rhsc for consideration. all workshops are championed by the regulators of various apec economies (for example, the us for medical product quality and supply chain integrity, korea for biotechnological products and pharmacovigilance, singapore for cellular-and tissue-based therapies, chinese taipei for good review practices and combination products, and thailand for gcp inspections). finally, this organization is partnering with other regional and international players in an effort to promote synergy and more effective use of resources. a good example here is the supply chain roadmap. this is a global issue and requires a global, coordinated approach. the rhsc roadmap is being implemented through the direction of an oversight committee that includes the who, ema, edqm, and the dra of nigeria. in doing so, apec takes account of and complements like initiatives, and can serve as a catalyst to global action. up to now, the apec did not proactively develop guidance or harmonized standards and requirements. the objective is to promote convergence via the dissemination of international harmonized information and recommendations (i.e., ich guidelines). to achieve these goals, the group has developed and funded several projects. in , the lsif released an "enablers of investment checklist," a voluntary guidance tool for member economies to assess and improve their innovative life sciences sector investment opportunities. one of the six principles covered by the checklist is "efficient and internationally harmonized regulatory systems." under this principle, the lsif promoted the development and implementation of focused efforts on harmonization towards international standards through recognized international organizations (i.e., ich). moreover, to support this objective, the lsif also proposed development of the following: ▸ a regulatory framework (transparent, predictable, and science-based) that allows for the quick introduction of new innovative products ▸ an efficient clinical trial regulatory system focused on safety, efficacy, and ethical standards ▸ an adequate number and level of training programs for regulatory personnel ▸ the publication of proposed regulations for stakeholder comments (which should be taken into account) ▸ laws providing for stakeholder consultation throughout the regulatory drafting and review process ▸ participation in international joint clinical trials performance metrics have also been defined to assess the implementation of the recommendations. finally, some of the other principles on this checklist also support cooperation and convergence as they assess the resources, exchange programs, intellectual property rights, and interagency coordination of life science policy and regulation. in addition to the "enablers of investment checklist," lsif has also developed projects focusing on specific topics of interest, such as: ▸ clinical trials: the area of clinical trials was selected as one of the lsif priorities in its strategic plan. assessment and improvement of the clinical trial system and regulation in each country has also been recommended in the lsif "enablers of investment checklist." the goal was to put in place an effective regulation infrastructure (by harmonizing regulatory practices and policies according to international best practices and standards). this activity includes work on regulatory process and framework (incorporating interagency review of new policies, guidances, and regulations), implementation and promotion of good clinical practices (gcps)/good manufacturing practices (gmps), protection and enforcement of intellectual property, establishment of clinical trials registries, and implementation of ich recommendations. to implement this goal and strengthen the dras' capacity to harmonize practices, a first workshop on "review of drug development in clinical trials" was held in march . several additional workshops concerning clinical trials and gcp (including clinical research inspection) have since been set up on this subject. the first workshop organized by the ahc in focused on the opportunities and challenges of multiregional clinical trials. each of the workshops serves to refine recommendations and showcase the china-japan-korea tripartite research initiative that is exploring possible ethnic differences between the three countries. as a result of workshops, two roadmaps have been developed: one for gcp inspection (under the leadership of thailand), and one for multiregional clinical trials (under the leadership of japan) [ ] . the focus will address gaps and needs not addressed by any other institution or regulatory authority to date. ▸ counterfeit medicines: another area of interest for lsif has been the increase in counterfeit medicines in the region. a series of seminars and workshops have been organized since january to examine ways to combat this problem. the lsif has also developed an anti-counterfeit medical product action plan. the objective of this plan is to share best practices in the detection and prevention of counterfeits to both dras and industry professionals, and organize systems to reduce the threat and occurrence of counterfeit medicines. finally, it is important to note that apec also promotes capacity building for its members. this objective is met through the organization of workshops, training courses, and seminars that enable people, businesses, and government departments to improve their skills and knowledge [ ] . the primary focus of apec is clearly the economy, and its objectives center on the facilitation of trade and business between member economies (with no integration plan). the asia-pacific region has consistently been one of the most economically dynamic regions in the world. since the establishment of apec in , the total amount of trade has grown significantly [ ] . apec's work under its three main pillars of activity has helped drive this economic growth. in , apec conducted an assessment to determine what progress has been made against the bogor goals of free and open trade and investment. the results were positive, showing that member economies have taken concerted action and progressed in a wide array of economic, trade, investment, and social areas. average tariffs in the region have been reduced from about % in to approximately . % in . nontariff barriers have also been reduced thanks to apec's work on trade facilitation. this progress by apec towards the bogor goals contributed to a more than five-fold increase in members' total trade (goods and services) between and (from us $ . trillion to us $ . trillion). finally, these activities contributed to real benefits for people across the entire asia-pacific region. over the span of years, from to , poverty was reduced by % (poverty levels are measured by calculating the population living on less than us $ a day) [ ] . apec represents a large region and approximately % of the world's population. this is obviously an advantage in facing the challenge of globalization. however, this size and magnitude can also be a disadvantage in terms of management. indeed, this region is very heterogeneous with countries at the two extremes of the development spectrum (i.e., very developed and very undeveloped countries). due to this disadvantage and the heterogeneity of this large region, it is difficult to adopt a treaty and to impose obligations on these members. for this reason, apec operates on the basis of nonbinding commitments where each country has the choice to implement the decisions. the implementation of economic measures (i.e., reduction of taxes and trade barriers to increase trade between members) is possible since it can quickly benefit all members. however, the lack of a treaty or obligations on members can sometimes be more challenging for more drastic long-term reforms (i.e., the harmonization of standards), as member economies have different priorities. the diversity of the apec region means that member economies will gradually move closer together in requirements and approaches, but not everyone will implement the measures at the same time. capacity and local realities must be taken into account. though technical cooperation is part of apec's objectives (i.e., apec is very involved on specific topics such as climate change), it is the second priority behind economic development. the health topic, managed by the health working group and the life science innovation forum, has clearly been funded because this topic has an impact on the economy. as stated on the apec website, "life sciences innovation is critical to growth and socio-economic development as healthy people produce healthy economies. efficient and effective delivery of patient focused products and services can improve a population's longevity, wellness, productivity and economic potential" [ ] . however, even if the above challenges are important, very positive outcomes have to be noted in terms of regulatory convergence in the pharmaceutical area. indeed, this organization supports convergence via the funding of projects and workshops. lsif was able to focus its effort on projects that impact all member economies (developed or developing), such as the coordination of multicountry clinical trials, the implementation of gcps, the quality of medicines, the counterfeit medicines problem, and the emergence of biosimilars. lsif also creates a forum that allows exchange of information between very different countries and between all the players (regulators, industry, and academia). this communication and dissemination of harmonized standards is very important, and is as essential as the development of the standards itself. in / , acknowledging a lack of strategic coordination, apec and lsif decided to better organize the activities. first, they established the ahc to facilitate the exchange of information and the creation of a network. second, they created the rhsc to strategically coordinate regional convergence. since this revision of lsif's structure and the creation of these two supporting bodies, significant progress has been made and apec has since declared that further harmonization to "achieve convergence on regulatory approval procedures" is targeted for [ ] . to support this goal, many important projects have been initiated on critical topics, such as product quality and supply chain integrity [ ] , good review practices [ ], gcp inspection [ ], pharmacovigilance [ ] , biotechnology products [ ], etc. all these changes and projects today represent great promise for this region, and the tools to be developed could also support global cooperation and convergence. the challenge is now to implement the plan and to continue to coordinate the projects in order to achieve the desired objectives. the recent establishment of the rhsc regulatory network (including dras not currently part of the rhsc) will certainly support the implementation of agreed-upon measures. many different types of bilateral cooperation have been established over the years. lll it would be difficult to list and discuss them all as several dozen exist. however, all these types of bilateral cooperation and agreements can be grouped into three categories based on their scope and objectives: ▸ cooperation between two developed countries: the objective of such cooperation is to exchange good practices and harmonize standards to avoid duplication of efforts (e.g., for orphan drugs). for example, the eu and the us developed a privileged relationship and the exchange of officials and staff between us fda and eu authorities allow for a closer collaboration, exchange, and therefore better understanding of each other. ▸ cooperation between one developed country and one developing country: this type of cooperation focuses on training, mentoring, and support from the developed country to the developing country. the objective is indeed to build expertise and capacity in the developing country based on the experience of the developed country. for example, the us fda has established several agreements with developing countries (e.g., brazil, mexico, south africa, taiwan, etc.) ▸ cooperation between two developing countries: by pooling experience and resources, two countries can better tackle issues of common interest. this type of cooperation allows for better allocation of sparse resources, and also increases interest for pharmaceutical companies (two small markets with different requirements would be less attractive to industry). for example, brazil has cooperation projects with cuba, dominican republic, mozambique, and several other countries [ , ] . one of the most advanced bilateral collaborations is between australia and new zealand. it represents a good example of a bilateral cooperation and harmonization model working towards a full integration of systems. indeed, after several years of convergence and harmonization, australia and new zealand agreed to establish a joint australia new zealand lll bilateral cooperation can involve two countries, but it can also mean the collaboration of a regional entity with another party. for example, the european union has been collaborating with australia, canada, the us, and japan, but also with the gcc group. therapeutic products agency (anztpa). this new agency will ultimately replace australia's therapeutic goods administration (tga) and the new zealand medicines and medical devices safety authority (medsafe). during the first meeting of the anztpa implementation ministerial council (melbourne, january , ), ministers from both countries agreed on key elements to establish the joint trans-tasman agency, and also how the joint regulatory scheme will be organized over a five-year period [ - ]. since then, the framework of the anztpa is under discussion . this cooperation/harmonization initiative was begun with the objective of sharing expertise and resources in order to provide health benefits for consumers by creating a world-class scheme. it is also expected that this single approval process for both countries will increase efficiency, improve the standards of medicines produced in the two countries, reduce regulatory costs for industry, and facilitate further economic integration [ ] . this initiative is a great example of successful bilateral harmonization and cooperation, and emphasizes the importance of a staged approach for this type of project. it also shows that such ultimate integration of systems is challenging. indeed, the agreement for a joint regulatory scheme was first reached in , but this project was not able to proceed because new zealand was unable to pass enabling legislation. negotiations between the countries were also suspended in july [ ] . the increased collaboration between europe and the us in the pharmaceutical domain is another interesting example of bilateral cooperation. though this cooperation does not follow an integration model, it is a well-developed bilateral initiative. it is a stepwise and structured program that is interesting as it provides a clear example of what such bilateral collaboration can achieve in a nonintegration process, and also outlines its limitations. it also provides examples of the measures and organization necessary to support such bilateral work. the european union (eu) and the united states of america (us), in addition to their collaboration within the scope of multilateral frameworks such as the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ich), have also established strong regulatory and scientific bilateral cooperation in the pharmaceutical sector. this bilateral cooperation promotes public health, safer trade of products, and harmonization of regulations. over the years, the scope of this transatlantic collaboration has increased, and today represents a good example of what bilateral cooperation can achieve. this collaboration mainly involves the european commission (ec), the european medicines agency (ema) and the united states food and drug administration (us fda). however, it is important to note that the us fda also maintains an active relationship with national dras throughout europe. confidentiality arrangements with the us have been signed at the european level (ec and ema) and also at the national level with austria, belgium, denmark, france, germany, ireland, italy, the netherlands, sweden, and the united kingdom. this is particularly important for collaboration in the area of inspections. it also allows the us fda to exchange information on products not approved via the centralized procedure (this exchange is done through the relevant reference member states [rmss]). the leaders of the eu and the us agreed on a framework for advancing transatlantic economic integration and established the transatlantic economic council (tec) to oversee the efforts outlined in the framework, with the goal of accelerating progress and guiding work between eu-us summits. moreover, confidentiality agreements have been established to create a framework allowing the exchange of confidential information between the eu and the us fda as part of their regulatory and scientific processes. they include information on advanced drafts of legislation and regulatory guidance documents, as well as nonpublic information related to ensuring the quality, safety, and efficacy of medicinal products for human (and veterinary) use. an implementation plan has also been agreed upon between all parties to allow for a successful exchange of information and documents between the eu and the us fda in accordance with the terms of the confidentiality agreements. the objective of this implementation plan was to describe the processes by which each party will undertake information and document exchange as envisioned by the confidentiality agreements. also, to facilitate this transatlantic pharmaceutical cooperation, the us fda and the ema have established "liaison officials." these liaison officials remain employed by their home organizations, but their physical location in the partner agency is designed to facilitate collaboration. their role is to facilitate regulatory and scientific cooperation between the us fda and the ema, and to coordinate information exchange. they also increase awareness of interaction opportunities with the ema and the us fda, and potential new areas of common interest [ , ]. in , the scope of this bilateral cooperation intensified with the establishment of confidentiality arrangements between the parties. these agreements signed on september , were then extended on september , . in september , these confidentiality agreements were extended again, and are now in effect for an indefinite period without the need for further renewal. these two official statements of authority and confidentiality commitment [ , ] restate the agreement to pursue in-depth collaboration and exchange of confidential nonpublic information between the us fda and the ema. it is interesting to note that these statements reiterate that the shared information includes confidential commercial or trade secret information (the us fda is required by current legislation to ask pharmaceutical companies before sharing trade secret information with counterpart dras). at the eu-us summit on april , , further momentum was given to regulatory collaboration with the signature of the framework for advancing transatlantic economic integration between the european union and the united states of america by ec president josé manuel barroso, german chancellor angela merkel, and us president george w. bush. this document called for more effective, systematic, and transparent regulatory cooperation, and the removal of unnecessary differences between regulations. it also specifically requested the promotion of "administrative simplification in the application of regulation of medicinal products." the objective of this bilateral process is more towards cooperation than harmonization per se. exchange of information between the parties allows for a better understanding of each other's systems and requirements, and therefore builds confidence and recognition facilitating convergence. this eu-us cooperation also tries to avoid future disharmony by upstream regulatory cooperation on new medicines legislation [ ] . the exchange of information and practices are well structured and occur on a regular basis, but the exchange can also be done on an ad hoc basis if necessary. ▸ regular exchange: the ema and us fda exchange a list of specific information on applications (both pre-authorization of new molecules and post-authorization of marketing products), including decisions made for such applications on a quarterly basis. they also exchange other information such as a list of good clinical practice (gcp) inspections or pharmacovigilance topics (either product-or nonproduct-related issues). ▸ ad hoc exchange: in addition to the exchange of new drafts of final legislation or guidelines (prior to publication), the eu and us fda also exchange information relating to scientific advice, difficulties in relation to the evaluation of applications, and urgent drug safety issues and other issues impacting public health. these types of information are exchanged prior to their release into the public domain. meetings or workshops on regulatory issues of mutual concern are also organized on an ad hoc basis. finally, the ema and the us fda publish an annual report summarizing their interactions under the confidentiality arrangements. these arrangements also provide for annual meetings between the us fda, the ema, and the ec to monitor the operation of activities within the scope of the agreed-upon implementation plans. however, it should be noted that the sharing of product-related information is limited to medicinal products evaluated or authorized in accordance with the eu centralized procedure, as well as medicinal products authorized at the national level by the eu member states, which are subject to arbitration or referral in accordance with european community procedures [ ]. initiatives related to general topics are reported below. in addition to these initiatives, cooperation has also been established in certain specific scientific areas or for a specific type of product (i.e., oncology, pharmacogenomics, nanotechnology, advanced therapy medicinal products [atmp], blood products, and vaccines). under the auspices of the transatlantic economic council, on november , the ec hosted the "transatlantic administrative simplification workshop" in brussels, belgium, which was co-chaired by the ec and the us fda and organized in collaboration with the ema and the heads of the eu national medicines agencies (hma). the key objective was to identify opportunities for administrative simplification through transatlantic cooperation in the removal of unnecessary burdens of administrative practices and guidelines. this would allow more human and fiscal resources to be focused on greater innovation and efficiency in the development of quality products. it was agreed that this project should not require change to legislation, and of course, the simplifications should maintain or increase current levels of public health protection. as a follow up to the transatlantic administrative simplification workshop, a "medicines regulation transatlantic administrative simplification action plan" was published in june , outlining administrative simplification projects to be taken forward. this document promoted further cooperation and pilot collaboration programs in major areas such as inspections, biomarkers, counterfeit medicines, risk management (content and format), scientific advices, biosimilars, pediatrics, and advanced therapies. during the annual ec/ema-us fda bilateral meeting in september , it was agreed that the majority of projects in the original plan had been successfully completed and that most of the pilot projects had been extended and became "standard" cooperation [ ] . ongoing developments and new initiatives in transatlantic administrative simplification are now included in the annual reports on interactions between the us fda and the ema. several projects have been initiated to increase collaboration on gmp and gcp inspections. ad hoc exchanges on specific products, quality defects, product shortages, and on draft guidelines also took place. ▸ gmp inspections: several pilot projects were first initiated in the context of the transatlantic administrative simplification workshop deliverables. an initial project (established in cooperation with the european directorate for the quality of medicine and the australian therapeutic goods agency) was conducted between december and december and related to gmp inspections of active pharmaceutical ingredients (api) manufacturers [ ] . the project's objective was to determine whether greater international collaboration and information sharing could help to better distribute inspection capacity, thus allowing more sites to be monitored and reducing unnecessary duplication. the second project, related to finished products, allowed eu-us fda joint inspections and was aimed at developing ways of working together on joint inspections of routinely scheduled sites in the territory of the us or eu, to reduce duplicate inspections and the resulting burden on both the pharmaceutical industry and the dras. this pilot phase, conducted under confidentiality agreements, allowed the development of new tools for work sharing and the exchange of information in order to share inspection reports and to organize joint inspections. increased transparency and visibility of inspections performed by participating authorities allowed a successful collaboration between authorities on manufacturing sites of common interest. it also increased the number of inspections performed that were of value to more than one authority. this pilot phase confirmed that such collaboration in the area of gmp inspections led to a reduction in duplicate inspections, more efficient use of combined inspectional resources, and wider global inspectional coverage. following the successful conclusion of the pilot, it was agreed to maintain the cooperation established [ ] . in december , the us fda and the ema decided to further enhance their gmp inspection cooperation by moving from confidence building to reliance upon [ ] . this initiative, launched in january , allows the ema and the us fda to share inspections of manufacturing sites in each other's territories. this important step follows the positive experience acquired through the pilot joint inspection programs and other information sharing projects that have occurred over several years. this strategy allows some inspections on each other's territories to be deferred or waived completely based on a number of considerations and on a risk-based approach [ ] . this strategy is applicable to gmp inspections related to manufacturing sites located in the us and the european economic area (eea), mainly focusing on routine post-authorization and surveillance inspections as a first step [ ] . the result of this arrangement could free up inspection resources that would then become available for inspections to other regions. ongoing ema-us fda joint inspection pilot projects will continue according to the agreedupon procedures [ , ] as it remains important to maintain mutual confidence and build further mutual understanding of gmp inspection approaches. some successful pilot programs will also be expanded to new partners such as the ongoing collaboration on gmp inspections of active substance manufacturers [ ] . due to the increased globalization of pharmaceutical product clinical development, and based on previous positive experiences in the gmp field, the ema and us fda agreed to launch a pilot ema-us fda gcp initiative. the objective of this gcp initiative, conducted between september and march , was to reinforce and systematize periodic information exchanges on gcp-related activities between the us fda and ema. these included the exchange of gcp inspection plans to improve inspection coverage, the exchange of information on applications to help identify candidates for collaborative inspections, and the exchange of inspection outcomes and reports (both negative and positive) and their potential impact. conduct of collaborative gcp inspections and the sharing of information on interpretation of gcp (such as draft guidelines or policies) were also part of this project. the pilot initiative has been very productive. a considerable amount of information has been exchanged on many products [ ] , and this communication (which included teleconferences and four face-to-face meetings) has facilitated improvements in the inspection coverage and decision-making processes of the agencies. the collaborative inspections conducted under the initiative have contributed greatly to each agency's understanding of the other's inspection procedures. they have also led to the identification of potential improvements to these procedures. both agencies have learned several general lessons during the process [ ]. in addition, exchanges of views on interpretation of gcp documents have also been organized. during the pilot initiative, the ema and the us fda have shared different pieces of gcp-related guidance documents, position papers, and policies in order to harmonize the agencies' understanding of gcp and to standardize the requirements for industry wherever convergence would be beneficial for the clinical research process. at the end of the program, both parties considered this pilot initiative very successful and agreed to continue this collaboration, incorporating lessons learned with the broader aim of moving from "confidence building" to the mutual acceptance of inspectional findings. the agencies will also expand the scope of the initiative to sites outside the us and eu [ ]. although not defined as a cluster, interactions in the area of safety continue to play an important part in the ongoing collaboration between the us fda and the ema. ▸ videoconferences take place on a bimonthly basis and include product-related issues and issues related to risk management. usually five to six products are discussed at these teleconferences. ▸ regular informal teleconferences in order to exchange information on emerging safety and strategic issues. ▸ ema shares the early notification system on a monthly basis and the us fda sends advance notice of publication of its quarterly update reports on potential safety signals. ▸ joint projects have also been established, such as the collaborative project on the progressive multifocal leukoencephalopathy research agenda to stimulate research into this important safety issue that affects some biological agents. the objective of this program is to allow interaction between the ema and the us fda assessors and sponsors during product development. this dialogue between the two agencies' assessors and sponsors on scientific issues [ ] aims to optimize product development and avoid both unnecessary testing replication and unnecessary diverse testing methodologies. such a procedure can be valuable for products developed for indications for which development guidelines do not exist, or if guidelines do exist, the ema's and the us fda's recommendations differ significantly. experts from the ema and the us fda exchange views and discuss draft responses to questions from the applicants on their clinical development programs or on new biomarkers. general principles for this voluntary parallel scientific advice were published in by the ema and the us fda [ ] . it is important to understand that this is a parallel procedure, and unfortunately, not joint advice. the goals of the ema and us fda are primarily to share information and perspectives, rather than specific harmonization of study or regulatory requirements (although they recognize that harmonization is a beneficial outcome). after this procedure, the two agencies conduct their individual regulatory decision-making process regarding drug development issues and marketing applications. each agency provides independent advice to the sponsor regarding questions posed according to their own usual procedures and timelines. the advice of each agency may therefore still differ after the joint discussion. however, in many cases, these discussions between regulators achieved a high degree of alignment and helped industry move closer to a global development plan [ ] . in , following a rather slow acceptance in previous years (due to hesitation from industries to use this procedure that does not commit the two agencies to issue common advice), the ema and the us fda discussed seven new parallel scientific advice procedures. who experts were involved in two of these procedures, due to the therapeutic area covered by the request. in addition to the formal parallel scientific advice exchanges between the us fda and the ema, ad hoc informal scientific advice teleconferences between the agencies took place for five products in [ ]. "clusters" or specific areas of mutual interest have been identified, and a more structured working relationship has been established. these clusters (i.e., oncology, pediatrics, orphan medicines, pharmacogenomics, blood products, biosimilars, and vaccines) facilitate the exchange of information through teleconferences relating to applications for marketing authorization and extensions of indications, including risk management plans [ ] . the latest cluster established, with a focus on biosimilars [ ], significantly increased cooperation between the agencies. the recent announcement from the ema stating that the agency will now accept data from reference product batches sourced outside the eu for biosimilar product applications [ ] will certainly boost the eu-us cooperation in this domain and the global development of biosimilar products. this decision follows the us fda proposal to also accept comparative data referencing a product that is not approved in the us [ ]. the eu-us fda collaboration on orphan drug development has been important. discussions between the ema and the us fda usually include sharing of information on applications submitted in order to approach and discuss criteria for designation. a common application form has been designed and agreed to so that sponsors can apply for orphan designation (of the same medicinal product for the same use) in both jurisdictions using this common form, facilitating the exchange of information. since , discussions have also included analysis of different opinions. on february , , the us fda and the ema announced that they had agreed to accept the submission of a single annual report mmm from sponsors of orphan products designated for both the us and the eu [ ] . each regulatory body continues to conduct their own review of the annual report to assure the information meets their own requirements. the use of one single report benefits both the sponsor and the two regulatory agencies. the sponsors benefit from the elimination of duplication of efforts to develop two separate reports, and the regulators can better identify and share information throughout the development process of an orphan product. collaboration in pediatrics is governed by the principles agreed to in [ ] . this framework includes information exchange (product-specific and general issues) and invitation of the other party to relevant pediatrics meetings. the two main objectives are ( ) to avoid exposing mmm these reports provide information on the status of the development of orphan medical products, including a review and status of ongoing clinical studies, a description of the investigation plan for the coming year, any anticipated or current problems in the process, difficulties in testing, and any potential changes that may impact the product's designation as an orphan product. children to unnecessary trials, and ( ) to facilitate the development of global pediatric development plans that are based on scientific grounds and that are compatible for both agencies. in practice, the cluster on pediatrics organizes monthly teleconferences between the ema's pediatric team and the us fda during which pediatric investigational plans (pips) are discussed in detail and information between the two agencies is exchanged. in addition, more general questions have also been addressed, such as extrapolation, choice of endpoints, and patient/parent reported outcomes. from september until september , products and four general topics were discussed [ ] . since the end of , us fda representatives have been able to participate in certain ema pdco discussions and vice versa. the ema has also provided the us fda access to its internal database that includes scientific details on all pips. several guidelines have been developed at the ich level (ich q , q , q ) in order to facilitate the implementation of "quality by design." taking into account the global perspective of pharmaceutical manufacturing, the ema and us fda agreed that it would be beneficial if at this early stage of implementation assessors from the us and eu could exchange their views on the implementation of ich concepts and relevant regulatory requirements using actual applications. a three-year pilot program, operating under the us-eu confidentiality arrangements, started in april . this program allowed parallel evaluation of "quality by design" aspects of applications submitted to the ema and the us fda at the same time [ - ]. on august , , the ema and us fda published the lessons learned and q&a resulting from the first parallel assessment. both agencies found the pilot program extremely useful to share knowledge, facilitate a consistent implementation of the ich guidelines, and harmonize regulatory decisions to the greatest extent possible [ - ]. the bilateral collaboration between the eu and the us has been extremely productive, and today it is recognized as a very successful initiative. its scope has increased over the years, from the basic exchange of information and harmonization of format to close collaboration and discussion of divergent positions. the liaison placement in each organization has also been an important decision to facilitate such cooperation. this increase in interaction, in a relatively short period of time, has been driven in part by reaction to crises and in part by proactive measures to enhance ema-us fda communication and collaboration [ ] . the establishment of the transatlantic administrative simplification project in has also been beneficial as it initiated several pilot projects that further demonstrated the need for, and benefits of, such collaboration. in general, activities in all the clusters have increased over time, and there has been an overall increase in the number of ad hoc requests for teleconferences on specific products and topics. following a significant increase between and , the total number of monthly us fda and ema interactions (i.e., teleconferences, document exchanges, etc.) now averages about per month, excluding document exchanges relating to cluster and pilot activities. significant achievements have also been made in several critical areas for public health such as orphan medicinal products (with the agreement on a single annual report), drug development (with the establishment of the parallel scientific advice procedure and collaboration on pediatric development), gcp and gmp inspections (with several successful pilot projects that increased collaboration), and safety of products (with close collaboration and regular exchange of safety information, risk management, and safety alerts). exchange of draft regulation (before release in the public domain) has also facilitated harmonization of practices and exchange of opinions. finally, tools for more effective tracking have also been developed. all these achievements confirm that collaborations between countries have a positive impact on public health. it is particularly evident in certain areas such as orphan drug development (for diseases affecting a small population) or the exchange of information relating to urgent drug safety issues (to better assess and understand risks). it is also important to note that this successful collaboration allows not only for the convergence of practices, but more importantly, this exchange of information and communication builds confidence in each other's systems, practices, and evaluations, allowing for a sharing of activities in certain areas. this is already the case in the area of inspection. in december , ema spokesperson monika benstetter stated that "each agency is now relying on its partner for drug manufacturing facility inspection data." [ ] the success of this transatlantic cooperation is partly due to the fact that it has been well structured and organized over the years. the establishment of clusters and then the creation of the liaison officials' positions nnn strengthen regulatory cooperation between the agencies. these decisions have been extremely beneficial from the perspective of education and timely communication. a large number of staff visits and exchanges also took place, and there is now more routine involvement in the scientific work of both agencies. the us fda representatives take part as observers in committee for medicinal products for human use (chmp) discussions, and the ema representatives are provided with access to webcasts of us fda advisory committees. however, other parameters such as those listed below have also been critical for this success, and clearly demonstrate their importance of this type of cooperation and harmonization initiative: ▸ first, it is clear that the political commitment to increased cooperation has been important. indeed, closer collaboration was evident after the signing of the "framework for advancing transatlantic economic integration between the european union and the united states of america" in by ec president josé manuel barroso, german chancellor angela merkel, and us president george w. bush. ▸ second, the establishment of confidentiality agreements, which since are effective for an indefinite period, allow both parties to exchange inspection reports or other nonpublic product-related information. this was critical in the establishment of collaboration as this communication on specific practical cases allowed the parties to nnn since , the fda has seconded a permanent representative to the ema's office in london. since early , the ema has seconded a representative to the fda's offices. discuss the similarities and differences of opinion when assessing product applications and documentation. although necessary, sharing only public information (i.e., new regulations and guidelines) does not provide this opportunity. ▸ third, this bilateral collaboration benefited from the fact that both parties had the same level of maturity and development of their systems and regulations, and similar public health needs and challenges (even if they were not always identical). ▸ lastly, the step-by-step approach established has been helpful because it provided clear priorities (with the clusters), allowed progressive exchange of information (from ad hoc requests to regular teleconference and nonpublic product information exchange), and time for each party to evaluate the partner agency's system and practices (with several specific pilot projects and visits/exchange of staff). although it took some time and a lot of effort, these different steps were beneficial as they facilitated transparency and confidence building. this clear understanding of similarities and differences of practices is a prerequisite to foster a culture of convergence of each agency's assessments and evaluations. to conclude, this bilateral collaboration is now very developed and has moved from confidence building and exchange of information, to recognition of each other's information and data for decision making. its success so far supports the continuation of this collaboration and even its extension, as confidence in each other's system continues to increase. although it is recognized that each party will remain ultimately responsible for public health in their territories, closer cooperation and convergence are obviously possible in many domains. finally, it would be beneficial to continue to expand successful projects to additional partners (as has been the case for gmp inspections of active substance manufacturers [ ] ) in order to foster greater international collaboration and information sharing. in addition to the bilateral, regional, and global regulatory initiatives described in previous sections, other technical and scientific harmonization projects have also been initiated. although these projects do not enter in the scope of this research (as they do not specifically relate to regulatory harmonization), it is important to mention them, as the standards they develop are often used by the regulatory harmonization initiatives. the following organizations and projects ooo have indeed supported the harmonization of standards in the pharmaceutical domain: ▸ the pharmacopoeial discussion group (pdg) involves (since ) the european pharmacopoeia (ep), the japanese pharmacopoeia (jp), and the us pharmacopeia (usp) to harmonize pharmacopoeial standards (i.e., excipient monographs and selected general chapters). it works in collaboration with ich, and who became an observer in may . ooo this list of organizations/projects below is provided as an example and does not represent an exhaustive list. ▸ the international organization for standardization (iso) is the world's largest developer and publisher of international standards (with a network of the national standards institutes of countries and a central secretariat in geneva, switzerland). this is a nongovernmental organization that today has more than , international standards and other types of normative documents covering many technical areas. ▸ the pharmaceutical inspection co-operation scheme (pic/s) facilitates (since ) ppp cooperation and networking in the field of good manufacturing practice (gmp) in order to lead the international development, implementation, and maintenance of harmonized gmp standards and quality systems of inspectorates in the field of medicinal products. the pic/s activities include the development and promotion of harmonized gmp standards and guidance documents, the training of inspectors, and the assessment of inspectorates. this initiative currently includes more than worldwide pharmaceutical inspection authorities. ▸ the council for international organizations of medical sciences (cioms) is an international, nongovernmental, nonprofit organization that was established jointly by who and the united nations educational, scientific and cultural organization (unesco) in . it includes over international, national, and associate member organizations representing many of the biomedical disciplines, national academies of sciences, and medical research councils. one of the objectives of cioms is to facilitate and promote international activities in the field of biomedical sciences, and its activities include programs on drug development and international nomenclature of diseases. ▸ the world medical association (wma) is an international organization founded in to represent physicians. today, it includes national medical associations, and its goal is to achieve consensus on the highest international standards of medical ethics and professional competence. the declaration of helsinki (developed in ) is the wma's best-known policy statement. finally, other groups of experts have also worked and released recommendations on specific topics related to the harmonization of pharmaceutical regulations (e.g., the phrma's [pharmaceutical research and manufacturers of america] simultaneous global development project [ ] or the nonprofit transcelerate biopharma project [ ] ). all these projects contribute to the global convergence and harmonization of pharmaceutical regulations. many harmonization initiatives have been established over the past several decades because regulators understand that cooperation can help in resolving the new challenges brought on by globalization. understanding the importance and advantages of cooperation and ppp the pharmaceutical inspection convention (pic) had been operating since . harmonization in supporting their mandate to promote and protect public health, many countries and regions have strongly enhanced their collaboration with other countries bilaterally and multilaterally at the regional and global levels. the globalization of the pharmaceutical market has highlighted several problems that have been associated with data generated from foreign countries and with imported products. for example, in , deaths associated with heparin imported from china into the us was due to contamination of its pharmaceutical ingredients at a chinese plant, and in panama, the diethylene glycol found in cold and fever medicine killed many people [ ] [ ] [ ] . these problems have been a wake-up call, and they further increased the recognition of benefits to be derived from leveraging the activities and resources of foreign counterpart dras [ ] . for example, the us has strongly increased their international collaboration in the pharmaceutical domain. us legislators decided that such international cooperation and harmonization activities are an integral part of the us fda's mission. indeed, the food and drug administration modernization act of stated that one of the missions of the fda is to "participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements" [ ] . since then, the us fda's international work has grown exponentially, especially over the past decade, to respond and adapt to the new global society [ ] . it has increased communication qqq and developed regulatory cooperation with other countries (bilaterally and multilaterally). the us fda's role in harmonization and multilateral relations is to coordinate and collaborate on activities with various international organizations (i.e., who, ich, pandrh, and apec) and individual countries on international standards and harmonization of regulatory requirements. in pursuit of appropriate international collaboration, the us fda utilizes a wide variety of international arrangements, including "confidentiality commitments" rrr and "memoranda of understanding and other cooperative arrangements." sss the ema is one of the us fda's closest regulatory partners. with china, uuu the us fda must increase its capacity for inspecting and analyzing chinese products before they are shipped to the us. in order to accomplish this, the us fda established an office in beijing, china in november and employed people (with additional employee hiring planned in the following years [ ] ). it has allowed for solid relationships with chinese regulators and exporters, and has trained more than , manufacturers and regulators on us safety standards in two years [ ] . finally, there has been increasing recognition within the us fda of the need to strengthen regulatory capacity and provide technical and scientific expertise to developing countries to ensure that products exported to the us meet us fda standards and adequate levels of patient protection. many cooperative initiatives have been established to meet this goal [ ] . other countries and regions, including the us, eu, australia, canada, singapore, and china. these bilateral collaborations are based on confidential agreements vvv and include information sharing. proactive exchange of staff has also been agreed upon with some dras ( ). japan's pmda has also developed privileged relationships with china and south korea following the pandemic influenza crisis [ , ] . since , this tripartite initiative has specifically cooperated on clinical research and promoted regional clinical trials [ , ] . in february , the advisory council approved the pmda international strategic plan as a framework for its international activities [ ] . this plan outlined the strategies for bilateral, regional, and global cooperation, and established an internal office in charge of international affairs. in line with this international strategic plan, further goals (to be attained by ) were published in november . finally, a roadmap for the pmda international vision was released in april . in this roadmap, the pmda defines more specific actions to support its international vision . the primary objective of this increase in international collaboration was to urgently resolve the "drug lag" www that has impacted the japanese pharmaceutical market in the past ( . years in ). many measures have been taken to improve the clinical testing environment (including the promotion of global clinical trials) and expedite drug approval decisions (via, among other measures, the increase of collaboration with the other worldwide dras). a global, simultaneous drug development approach has also been strongly recommended. many actions, including release of guidelines, have been taken to facilitate such global development [ ] . in addition to the us and japan, other major dras of developed countries (such as health canada and the australian tga) also recognized the important added value of global cooperation and therefore increased their involvement in international activities. the eu, based on its prior experience of harmonization and cooperation from the establishment of its own system, has also developed external bilateral and multilateral collaborations and is today an important international partner. although these diverse, coexisting, bilateral, regional, and global initiatives create complexity, it is important to note that they are complementary. global harmonization does not preclude having regional harmonization and regional harmonization does not preclude bilateral agreements. in fact these three levels of harmonization and cooperation bring about different added value: ▸ bilateral agreements allow for a bigger exchange of information, including productspecific data, through confidential agreements and the development of privileged relationships (and trust) between regulators as they allow for assessment of one another's vvv in the case of china, a cooperative agreement has been established. www drug lag is defined as the difference of availability of new medicines between the us and japan. systems and practices. xxx these assessments are indeed critical for confidence building and can ultimately support the signing of agreements, allowing for recognition of inspection or the exchange of nonpublic information (e.g., eu/us collaboration and confidentiality agreements). bilateral collaboration also helps strengthen relationships, which would be more difficult in the context of a multilateral initiative, and facilitates training and mentoring activities between developed and developing countries. ▸ regional harmonization allows for the harmonization of policies between countries that are usually closer in term of systems, cultures, and levels of development. it is indeed easier to harmonize closed systems and policies between countries of similar culture and environment (for example, it is more difficult to harmonize systems and policies between asia and north america because they have very different medical practices and cultures). this level is essential for global harmonization because it provides a structure. achieving global harmonization without a supporting regional organization structure is impossible. this regional level allows for inclusion of regional realities and difficulties in global discussions, and eases the diffusion and implementation of the global recommendations. ▸ global harmonization is the highest level of harmonization. compared to regional harmonization, the global harmonization initiative is not driven by economic objectives; the goal is not to create a free trade area or a single market, but to develop global consensus and standards in order to allow the world's population to have access to medicine and innovative therapies. to conclude, these bilateral, regional, and global cooperative activities have been beneficial as they supported the harmonization of requirements globally and therefore facilitated the availability of safe and efficacious medicines, critical in promoting global public health, on a worldwide basis. many topics and standards have already been partly or fully harmonized at a bilateral, regional, or global level. for example, most of the requirements regarding the conduct of nonclinical studies, and also the gmp and good clinical practice (gcp) principles, have been agreed on, allowing for joint inspection projects. a common format of application has been developed, and many technical aspects have been harmonized through the ich's work. collaboration has also been increasing in resolving major topics requiring global interaction, such as orphan drug evaluation yyy and development of medicines for the pediatric population. zzz confidence and trust have been built between developed countries through pilot projects, but xxx for example, bilateral collaboration allows two countries to assess their respective inspection systems or systems to control critical information (such as trade secrets). such assessments of each other systems could be possible in the case of multilateral collaboration, but would be more complex. yyy because only a small number of the population is affected by these life-threatening diseases or serious conditions, it is critical to have global requirements in order to facilitate global clinical studies. moreover, the pharmaceutical industry has been reluctant to invest in the research and development of medicinal products to treat these conditions. the development of global requirements allows quick access to the global market and therefore allows a better return on investment. zzz it is critical that countries cooperate in this area to avoid exposing children to unnecessary trials. also through the location of official liaisons in other dras to facilitate collaboration. this has been positive, and this new type of interaction is very promising as it increases relationships and allows for the better exchange of experiences and information. aaaa the establishment of liaisons in other countries also allows more proactive measures and risk analysis in the area of quality systems and inspections [ ] . exchanges of information between dras have also dramatically increased. this regular communication between regulators facilitates evaluation of risk (e.g., via exchange of safety alerts) and assessment of new medicines. finally, systems have been put in place to help developing countries (e.g., cpp scheme, prequalification of medicines, article of european regulation (ec) no / , etc.). however, without underestimating all these important positive outcomes, it is clear that differences still exist and that further efforts will be required to support this ongoing harmonization process. there are still differences between countries in terms of standards and strategies to assess compliance against standards. the conduct of global clinical studies continues to present many challenges (i.e., related to registration, conduct of the studies, and also the use of data), and there are still several clinical trial registries and databases in use. the safety of medicines has been one of the main focuses of dras in the past due to major problems and events, but there has not been a real effort toward worldwide harmonization regarding risk-mitigation strategies. additionally, new standards continue to be developed by different bodies (i.e., ich vs. regional organizations) in parallel that not only duplicate efforts, but also create disharmony (e.g., biosimilars requirements had first been developed by individual countries and also by who). there is also a significant difference in the level of implementation of harmonized standards (i.e., the ich recommendations/guidelines) between countries, and the ctd format has still not been implemented in all countries. it has also been reported that differences between developed and developing countries has in fact continued to increase in the past several years due to the increased complexity of technologies associated with the development of new therapies. even between two close partners like the us and eu, which have developed a privileged partnership and strong cooperation, there are still important differences in standards. for example, the us is still requiring two placebo-controlled studies to determine efficacy of a new medicine, while the eu is more interested in comparative studies using an active comparator. this difference is due to different legal requirements and scientific opinions regarding the value of such comparative data [ ] . this situation may change in the future with the growing interest in the us for "comparative effectiveness" promoted by the obama administration. finally, this complex worldwide harmonization context (with increased communication and exchange of experience, information, and good practices) requires good communication and coordination between all these ongoing initiatives. even if such communication was initiated by who and ich (with the gcg group), further improvement would still be needed. this enhanced coordination of international cooperation would indeed be beneficial, as it would provide the necessary transparency regarding the focus and responsibility of each initiative (i.e., development of standards, coordination of implementation of recommendations, etc.). aaaa exchange of information and best practices has been one of the most important outcomes of the eu/us bilateral collaboration. it would also facilitate the appropriate use of resources and expertise, and therefore avoid duplication of efforts or conflicting recommendations and actions. overlapping membership between the initiatives bbbb may not be fully efficient, and can create confusion and duplication of work. although the increased coordination of these diverse initiatives would be beneficial, it will certainly be challenging. it will need to be thoroughly structured and implemented, and it will also be critical that the coordinated body is a recognized and experienced entity, with appropriate mandate and power. under this directorate, the us fda's office of international programs serves as the agency's focal point for all international matters and is responsible for maximizing the impact of the us fda's global interactions. additional us fda reorganizations were also announced in to further respond to drug industry globalization [ ]. also, in addition to china, the us fda now has staff stationed permanently in india the total number of shipments of us fda-regulated products from china increased from approximately . million to . million. of the . million entry lines arriving in , % were drugs and devices, and % were human food products key: cord- -gwhb e q authors: khan, ali s; lurie, nicole title: health security in : building on preparedness knowledge for emerging health threats date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: gwhb e q nan ideas, information, and microbes are shared worldwide more easily than ever before. new infections, such as the novel infl uenza a h n or middle east respiratory syndrome coronavirus, pay little heed to political boundaries as they spread; nature pays little heed to destruction wrought by increasingly frequent natural disasters. hospital-acquired infections are hard to prevent and contain, because the bacteria are developing resistance to the therapeutic advances of the th century. indeed, threats come in ever-complicated combinations: a combined earthquake, tsunami, and radiation disaster; black outs in skyscrapers that require new thinking about evacuations and medically fragile populations; or bombings that require as much psychological profi ling as chemical profi ling. response requires up-to-date laboratories with genetic sequencing capabilities for infectious agents and rapid detection methods for chemical and radiological threats, nimble medical and epi demiological response units, and an alert and prepared workforce. these complex and interconnected problems have spurred innovation across government to create interconnected solutions. increasingly, the usa is building national capabilities to improve health security, which is defi ned as a state in which the nation and its people are prepared for, protected from, and resilient in the face of health threats. to ensure a nation's health security entails preventing, protecting, mitigating, responding to, and recovering from all hazards that adversely aff ect health, requiring strengthening health and response systems at the local, state, and national levels. these capabilities are being built to address a wide range of hazards so that a strong base of readiness for any threat is developed. public health advances that have resulted in a more resilient and prepared nation and that have led to such system strengthening at all levels of government have been described, and include improvement and coordination of public health infrastructure through the national incident management system (nims), expansion of the strategic national stockpile (sns), upgrading of medical care and countermeasures capabilities, and improvement of laboratory expertise and capacity. we describe continued progress in the ongoing commitment to keep people in the usa healthy and safe (panel ). in an emergency, capabilities from all sectors are used to mitigate the acute event. however, the public health consequences of an event are not always visible, and health expertise has historically been conspicuously absent from emergency management. over the past decade, awareness has grown that health is part of almost every event; much progress has been made in emergency management to use public health expertise in planning, response, and recovery. this integration is core to national activities to promote health security. nims was established in as a comprehensive, systematic, principle-driven approach to management of emergencies of all causes and sizes. the department of health and human services (hhs) uses, supports, and promotes nims with local and state health departments through both the centers for disease control and prevention's (cdc) public health emergency preparedness programme and the offi ce of the assistant secretary of preparedness and response's hospital preparedness program to be used whether responding to daily incidents or natural disasters. as seen in the boston marathon bomb attack on april , , these investments and use of nims are very worthwhile. in boston, the city's public health commission oversees citywide emergency response, requiring close integration of emergency response and public health. immediately after the bombings, medical and health department personnel began treating more than injured people, and coordinated hospital transportation for people-all within min. boston's health authorities credited their quick response to robust exercise and planning, the city's strong interagency partnerships, and support from the state and federal government. this support included use of a capabilities-based approach to preparedness, with concrete measures of performance (panel ). part of the city's training also included a seminar in with doctors from india, spain, israel, the uk, and pakistan-countries that had managed blast injury terror attacks. on the day of the boston marathon bomb attack, local hospitals were able to draw from lessons learned in those and other exercises to respond with great speed and success. additionally, hhs used a new mental and behavioural health concept of operations to deploy federal mental health responders. this mental health framework is an integral part of eff orts throughout hhs to identify, study, and facilitate activities that promote resilience and recovery in communities across the nation. public health information sharing has improved rapidly. so-called digital epidemiology has enabled practitioners and researchers to use electronic databases and information to enhance traditional surveillance methods. in , hhs launched its now trending developer challenge to create programmes for health departments to monitor social media during an outbreak. the challenge resulted in mappyhealth, a twitter monitoring programme now being piloted for digital health surveillance around the country, helping offi cials examine real-time events. digital surveillance was used by public health workers during the infl uenza a h n outbreak to monitor chinese social media for events, myths, and concerns. improvements in digital surveillance have also improved public communication. local health departments that can monitor twitter can give immediate feedback to correct dangerous mistruths that are contagious on social media. cdc's @cdcemergency twitter feed, fi rst established during the infl uenza a h n response, now reaches more than · million people with emergency health information. during the japan nuclear disaster response, twitter was used to correct the dangerous myth that healthy people in the usa should take potassium iodide to prevent harm from radiation. these technological advances have been developed in parallel with diplomatic information sharing advances. who's international health regulations and multilateral collaborations, such as the global health security initiative, have provided a framework for international cooperation during public health disasters. improved capacity and the high priority placed on rapid information sharing led to china's timely reporting in of clinical and genetic information about infl uenza a h n and early sharing of isolates, by contrast with the response to sudden acute respiratory syndrome (sars) a decade earlier, when information was slower to emerge. , cloud computing allowed for distribution of validated epidemiological and analytical programmes to the global community, while allowing china to share genomic sequences, providing the opportunity for immediate actions to analyse the viral genome and develop vaccine candidates. the public health emergency medical countermeasure enterprise was established by hhs to coordinate federal eff orts and build new ways to respond to st century health threats-from discovery to deployment. the programme generated a government-wide strategic plan to build all-hazards capabilities and countermeasures throughout federal public health agencies. one cornerstone of the programme is the development of new medical countermeasures. since july, , seven products for anthrax, botulism, and infl uenza have received approval from the food and drug administration. the sns contains substantial formulary to provide prophylaxis or treatment to address the deliberate dissemination of anthrax, plague, botulism, or tularaemia, and enough smallpox vaccine to immunise every person in the usa. botulism antitoxin, anthrax immune globulin, and vaccinia immune globulin are also routinely made available for distribution for routine public health indications as needed. sns materials can be delivered anywhere within the usa within h. furthermore, the hhs medical care and countermeasures strategy-which includes a focus on development of the next generation of infl uenza vaccines, diagnostics, and novel antivirals-has also led to advances in vaccines for seasonal infl uenza, and better prepared the nation for the next pan demic. for example, the us government now has licensed cell-based and recombinant seasonal infl uenza vaccines and have stockpiled pre-pandemic cell-based vaccine. network and can test for biological agents. regional chemical laboratories are also able to measure human exposure to toxic chemicals through tests of clinical specimens. • the select agent regulations, updated in , came into full eff ect in april, . the regulations prioritised selected agents and toxins on the basis of risk to the public, established suitability standards for people with access to the most threatening (tier ) agents and toxins, and established personal reliability measures to improve biosafety and biosecurity. • the national disaster medical system has improved how it organises and deploys more than of its nationally distributed disaster medical assistance teams, mortuary response teams, and veterinary response teams, in addition to other specialised units that provide medical response surge during disasters and emergencies through on-scene medical care, patient transport, and the delivery of defi nitive care through its participating hospitals. • the biomedical advanced research and development authority (barda) is mandated to support the advanced development of medical countermeasures, and has built a pipeline of more than novel drugs or diagnostics for chemical, biological, radiological, and nuclear threats and pandemic infl uenza. seven of these products have received approval from the food and drug administration. barda has provided new products under project bioshield that can be distributed in a public health emergency. • the strategic national stockpile was authorised and expanded, ensuring the availability of key medical supplies. all states have plans to receive, distribute, and dispense these assets. increasingly, the usa seeks to develop products that can address countermeasure requirements and also day-to-day needs. as a result, these government investments in products such as next-generation antimicrobials for biological threats can be supported by the market to address routine public health problems, such as antimicrobial resistance. in addition to storing these medical countermeasures, the sns has established a nationwide readiness programme with metropolitan areas in its cities readiness initiative. cities receive technical assistance in developing plans to receive, distribute, and dispense medical assets, and must plan to respond to a large-scale bioterrorist event within h. this initiative refl ects the value of having all the components of the system work together: research scientists work alongside logistics experts to ensure that as they build new life-saving products, others are making sure that they can get them to the right place, under the right conditions, in the right amount of time. the ndms is made up of more than citizen responders, including physicians, mid-level providers, nurses, emergency medical service personnel, and leadership staff ; and civilian hospitals across the country that can support the defi nitive care for patients who are evacuated from an aff ected area of all kinds of hazards. federal medical stations, components of which are also stored in the sns, can be deployed and staff ed by the us public health service and ndms medical personnel. after hurricane sandy, these stations were deployed along with more than mobile fi eld care sites to provide both human and animal care. these resources provided relief for overworked local medical responders and facilities, and helped community members maintain access to critical services. multidisciplinary medical teams were able to assess and treat both acute and chronic medical needs, and either discharge or transfer patients for further care as necessary, helping to relieve the medical surge that the local hospitals were experiencing. the teams also assisted responders who got sick or injured in going back to work quickly, strengthening community resilience. cdc and hhs have supported public health laboratories around the country since the mid- s, through epidemiology and laboratory capacity-building cooperative agreements and the laboratory response network (lrn). the -member lrn, founded in , assures standardised equipment, reagents, and protocols for testing, quality assurance and quality control, and result messaging. funding has gone towards renovation of old state and local public health laboratory facilities, purchasing of state-of-the-art testing equipment, and paying for more than laboratory worker positions each year. nowadays, lrn laboratories can undertake rapid tests for high-priority biological agents such as those that cause anthrax, smallpox, and plague. receipt of test results within hours, not days, is crucial in the event of a biological or chemical attack. state laboratories showed their response capacity and the benefi ts of these investments during the multistate fungal meningitis outbreak, during which around people were infected and more than killed by contaminated spinal and paraspinal steroid injections. the tennessee department of health identifi ed and raised the alarm on the initial cluster of cases. the virginia department of health and state public health laboratory identifi ed a rare fungal pathogen, exserohilum rostratum, which contaminated the steroid injections-a critical discovery. the michigan department of community health identifi ed the fi rst case of a joint infection from the injections. these fi ndings aided the response in several ways. tennessee's actions to identify the cluster led to a nationwide patient notifi cation eff ort so that cases were quickly discovered and treated. by identifi cation of the fungus involved, time was saved in developing specifi c diagnostic, patient management, and treatment guidelines. the michigan discovery of the joint infection led to instructions for doctors to look for medical complications that were related to the injections. the department of health and human services (hhs) identifi ed the following public health and health-care preparedness capabilities (shown in their corresponding domains) as the basis for state and local public health and health-care preparedness. health-care coalitions supported by hhs helped states to assist hospitals in managing the surge of patients. these enhancements in our national public health laboratory system capabilities have helped to support the development of laboratories worldwide. in this interconnected world, fostering this and the other public health preparedness capabilities overseas is crucial to us health security. hhs has worked to build infrastructure and provide technical assistance with partner countries in asia, africa, and latin america. as a result, us partners are building the scientifi c capacity to detect, contain, and respond to novel threats before they become global threats. bioterrorism, pandemics, and other global threats to the nation's health security remain major concerns. we must ensure that lessons learned locally, such as those of the boston marathon bombing or response to hurricane sandy, are shared and implemented widely in us states and cities with adequate funding and support. much work remains to make the eff orts and improvements of the past few years integral components of routine health systems, addressing existing gaps in preparedness, and to duplicate these eff orts globally as part of the new international global health security agenda in support of the international health regulations. all this work has to be accomplished in the midst of substantial decreases in federal and state funding for public health and health-care preparedness. in view of the challenging fi scal environment, additional progress will need increased emphasis on a risk-based approach and focus on a very limited number of priorities. one of the most pressing priorities is meeting the needs of vulnerable populations who tend to have poor health outcomes during and after disasters. although some innovative eff orts have been launched at hhs to increase access to federal data to address the needs of vulnerable populations, this population is often not included in emergency planning processes despite their disproportionate vulnerability and numbers. they include a large part of society, not limited to children; elderly, poor, and disabled people; and those not fl uent in english. although the public health community is aware of this need and many important eff orts are being made across the country, [ ] [ ] [ ] we need more strategies to locate, engage, and communicate with vulnerable populations and make them the focus of our preparedness planningnot the annex. addressing the needs of these populations and other related eff orts to foster better personal and community preparedness are concrete measures to create resilient communities. this shared responsibility for resiliency is implicit in the all-community approach to ensure us health security. previous major disasters and mass casualty events drew attention to continued stress points for health-care services including insuffi cient back-up emergency power and decision points for evacuating patients versus sheltering in place; shortages of emergency medical services and medical supplies and insuffi ciently trained staff ; and the inability to refi ll prescription medications. the cornerstone of eff orts to improve the health-care delivery system's ability to surge and be resilient has been to establish and sustain health-care coalitions. establishment of broad-based health-care coalitions are a solid beginning, but this approach will be successful only if we learn from and not just record lessons from previous disasters. eff orts should incorporate changes on the basis of these lessons, and include robust integrated planning and exercising of the health-care and public health systems that are coordinated with emergency management. we need to foster improved and expanded stakeholder engagement in health-care coalitions with increased inclusion of emergency medical services, public safety offi cials, and other crucial infrastructure partners such as the power and water sectors. information systems will be critical in helping these coalitions to work together, share information and resources, and coordinate a system-wide response. additionally, alternative models are needed for fi nancing both preparedness and response activities. other priorities include embracing new technology for disease monitoring and real-time information sharing; improving the evidence base; expanding preparedness principles to include climate disruption; and encouraging even more cross-sector integration between public health, health care, emergency management, and, especially, the private sector. these are just a few necessary eff orts across public health agencies that seek to make americans more resilient and prepared. building on this integrated and systematic approach to health security will strengthen us health security for decades to come. us department of health and human services. national health security strategy public health preparedness and response in the usa since / : a national health security imperative public healthspecifi c national incident management system trainings: building a system for preparedness public health workers at center of boston bombing response: preparedness pays off during crisis digital epidemiology infl uenza a (h n ) and the importance of digital epidemiology the dynamics of health behavior sentiments on a large online social network the h n infl uenza virus in china-changes since sars arms race: getting ahead of killer microbes us centers for disease control and prevention. multistate fungal meningitis outbreak investigation the critical role of state health departments in the us fungal meningitis outbreak: key eff orts asph/cdc vulnerable populations collaboration group preparedness resource kit applying community engagement to disaster planning: developing the vision and design for the los angeles county community disaster resilience initiative responding to the deaf in disasters: establishing the need for systematic. training for state-level emergency management agencies and community organizations both authors contributed equally to the writing and editing of this viewpoint, and approved the fi nal draft. we declare no competing interests. we thank vivi abrams siegel for research, drafting the initial outline, and editorial assistance, and kacey wulff for editorial assistance. key: cord- -ddgoc yk authors: gavin, blánaid; hayden, john c.; quigley, etain; adamis, dimitrios; mcnicholas, fiona title: opportunities for international collaboration in covid- mental health research date: - - journal: eur child adolesc psychiatry doi: . /s - - - sha: doc_id: cord_uid: ddgoc yk nan the covid- pandemic has occurred at a moment in history when socio-political factors are promoting a turn towards national insularity and increased borders, parallel to a devaluation and politicisation of expertise. from a mental health perspective, this global crisis starkly illustrates the inherent dangers in such trends. this is surely an opportune moment for mental health scientists, practitioners, stakeholders and experts by experience to lead by example and to develop an international collaboration in pandemic mental health science with the ultimate aim of making evidencebased guidance and resources rapidly and universally available to optimise outcomes for all [ ] . data from previous pandemics suggest that psychological morbidity will inevitability rise, endure longer and peak later than the pandemic itself [ ] . however, the impact of a pandemic on mental health-care systems had not been widely considered by multidisciplinary mental health practitioners prior to covid- . moreover, the dearth of translational research relating to pandemic mental health science has resulted in extremely limited practical, real-world supports being quickly available to guide frontline staff. these deficiencies represent an opportunity for international collaboration to strategically advance care without duplication of effort and for the benefit of all. the implications for the current pandemic on mental health are numerous and complex. research from previous outbreaks of sars-cov and mers-cov and from the current covid- has shown a direct effect of virus in causing delirium in a significant proportion of patients in the acute stage or even before other symptoms appears. similarly high proportions of depression, anxiety, fatigue, post-traumatic stress disorder, and sleep disorders have been reported during the acute illness but also in post-illness [ ] . in addition, several treatment options including steroids or chloroquine can also cause psychiatric side effects such as mania and psychosis. the direct effect of covid- in the brain and the consequent psychiatric disorders of it is still unknown, although preliminary results have shown that covid- can affect the central nervous system at least in adults [ ] . the effects of covid- in children seems less severe and often infected children remain asymptomatic for the most part. but at the moment, we do not know if the presence of virus in the brain of infected children or in other organs can have long-term effects in their health and especially in brain development. earlier indications show that the covid- is neurotropic and thus can have long-term neuropsychological effects [ ] . now is the time to start longitudinal studies of infected and unaffected children to examine and compare their developmental trajectories. furthermore, children and adolescents with pre-existing mental health problems and neurodevelopmental disorders are particularly vulnerable to relapses and worsening of symptoms during the time of those sudden changes in their routine. school closure, social distancing, quarantine and uncertainty also are expected to have psychological impact in youth without pre-existing psychopathologies. [ , ] . in addition, in some countries the reopening of schools and the stopping of restrictions of movements have been replaced by the using of masks in schools and in public places. part of the emotional development and the emotional intelligence is the recognition of the emotions of others which lead to social awareness. the emotion of others is developed through face recognition. the use of masks can prevent especially the youngsters to develop those abilities. the logistical and financial barriers to addressing these unknown research questions are significant. the feasibility and generalizability of such studies would be greatly improved by international partnership. frontline mental health-care clinicians have had to respond without an evidence base and adequate resources to inform management plans. in the authors' own country, ireland, while there has been an impressive response by mental health systems rapidly adapting models of service provision in an effort to ensure continuity of care, patient care has undoubtedly been negatively and perhaps unnecessarily impacted by delays in access to basic pandemic care algorithms to guide routine decisions such as medication titration and physical monitoring at home in addition to delays in access to tele-mental health. in addition to the clinical duties during the pandemic, consultant psychiatrists in ireland have extra duties as they are also the clinical leaders of their teams. thus, among their duties are to re-organise the teams to a safer response in their clinical work, to support them, to prevent demoralisation, to motivate them and to resolve potential conflicts. resources are scarce, and likely to remain so as health systems manage the health overspends arising from the pandemic. holmes and colleagues' [ ] recent position paper outlining multidisciplinary research priorities for this pandemic is characterised as a call for action for mental health science. if these ambitious and important research priorities are to be realised, maximal efficiency and co-operation must also be in place. as mental health-care providers and academics in ireland, trying, with difficulty, to urgently highlight psychological and psychiatric issues of relevance in the pandemic while attempting to provide the much needed evidence-based guidance within extremely limited resources [ ] , we urge collaborative, international action forthwith. author contributions all authors contributed to the discussion and design of the correspondence. all authors reviewed the final correspondence before submission. funding no funding was received in relation to this correspondence. ethical approval ethics approval was not sought as this correspondence does not involve the study of human or animal data. the lancet psychiatry commission on psychological treatments research in tomorrow's science suicide risk and prevention during the covid- pandemic psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the covid- pandemic nervous system involvement after infection with covid- and other coronaviruses neurotropic mechanisms in covid- and their potential influence on neuropsychological outcomes in children editorial perspective: perils and promise for child and adolescent sleep and associated psychopathology during the covid- pandemic coronavirus disease (covid- ) and mental health for children and adolescents multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science psychological interventions for people affected by the covid- epidemic key: cord- - mzs dl authors: barnett, daniel j.; balicer, ran d.; blodgett, david; fews, ayanna l.; parker, cindy l.; links, jonathan m. title: the application of the haddon matrix to public health readiness and response planning date: - - journal: environ health perspect doi: . /ehp. sha: doc_id: cord_uid: mzs dl state and local health departments continue to face unprecedented challenges in preparing for, recognizing, and responding to threats to the public’s health. the attacks of september and the ensuing anthrax mailings of highlighted the public health readiness and response hurdles posed by intentionally caused injury and illness. at the same time, recent natural disasters have highlighted the need for comparable public health readiness and response capabilities. public health readiness and response activities can be conceptualized similarly for intentional attacks, natural disasters, and human-caused accidents. consistent with this view, the federal government has adopted the all-hazards response model as its fundamental paradigm. adoption of this paradigm provides powerful improvements in efficiency and efficacy, because it reduces the need to create a complex family of situation-specific preparedness and response activities. however, in practice, public health preparedness requires additional models and tools to provide a framework to better understand and prioritize emergency readiness and response needs, as well as to facilitate solutions; this is particularly true at the local health department level. here, we propose to extend the use of the haddon matrix—a conceptual model used for more than two decades in injury prevention and response strategies—for this purpose. sudden fever and dry cough, along with chills and muscle aches. despite these symptoms, after the flight he still managed to drive from dulles airport to anytown, maryland. within hr of arriving at his apartment to his wife and two children in anytown, mr. smith's condition rapidly deteriorated, and he began to have difficulty breathing. his wife drove him to general hospital emergency department in anytown. mr. smith was admitted to the intensive care unit at general hospital on march, with a suspected clinical diagnosis of severe acute respiratory syndrome (sars). three days later ( march), doctors at one hospital in washington, dc, one hospital in baltimore, and general hospital in anytown admitted three patients each (total = patients) with histories of acute onset of high fever (> °c) and dry cough followed by shortness of breath. upon taking a detailed travel history of these patients, physicians determined that seven of these nine patients (including the three new patients presenting to general hospital in anytown) had taken orioles airways flight on march . two others had recently traveled to the united states from guangdong province, china. these developments were reported on a -hr cable media outlet before local, state, and federal public health officials had a chance to generate a formal press release. meanwhile, at general hospital in anytown, the condition of mr. smith steadily worsened despite aggressive treatment efforts, and he died of respiratory failure on the afternoon of march. by hr on march, local, national, and international media outlets had converged upon anytown, with a sea of television trucks and satellite equipment gathered outside general hospital. the system became flooded with calls from anxious citizens throughout anywhere county, and cell phone networks were quickly overwhelmed by call volume. the mayor of anytown, maryland, and the local county health commissioner prepared to deliver a joint press conference with the state health commissioner at hr, followed by an address by the president to the nation on these developments at hr. by march , a total of cases of sars were confirmed in maryland, pennsylvania, northern virginia, and the district of columbia. twenty of these patients had died thus far from respiratory failure. the news of these deaths brought added fear to the region and the nation. schools had been closed and unnecessary gatherings canceled in anytown and the rest of the affected region for the past days. epidemiologic workup by the centers for disease control and prevention (cdc) in conjunction with state and local health departments revealed that most cases in this sars outbreak were traceable to mr. smith, the anytown businessman who had been exposed to sars while on business in taipei and who subsequently exposed fellow passengers on orioles airways flight because of a faulty on-plane ventilation system. the remaining cases were traced to the two travelers to baltimore who came from guangdong province in china. questions. what are the hospital infection control issues associated with a sars outbreak, and what are the most effective approaches to address these issues? what type state and local health departments continue to face unprecedented challenges in preparing for, recognizing, and responding to threats to the public's health. the attacks of september and the ensuing anthrax mailings of highlighted the public health readiness and response hurdles posed by intentionally caused injury and illness. at the same time, recent natural disasters have highlighted the need for comparable public health readiness and response capabilities. public health readiness and response activities can be conceptualized similarly for intentional attacks, natural disasters, and human-caused accidents. consistent with this view, the federal government has adopted the all-hazards response model as its fundamental paradigm. adoption of this paradigm provides powerful improvements in efficiency and efficacy, because it reduces the need to create a complex family of situation-specific preparedness and response activities. however, in practice, public health preparedness requires additional models and tools to provide a framework to better understand and prioritize emergency readiness and response needs, as well as to facilitate solutions; this is particularly true at the local health department level. here, we propose to extend the use of the haddon matrix-a conceptual model used for more than two decades in injury prevention and response strategies-for this purpose. of advance planning strategy could a local public health department use to identify the contributing factors to this public health emergency? what approaches could a local public health department use to deliver comprehensive public health prevention, intervention, and risk communication measures before, during, and after such an outbreak? it was late in the afternoon on a typically warm, humid, sunny july afternoon in anytown, maryland. thousands were gathered at the anywhere county fairgrounds in anytown in preparation for that evening's upcoming parade and celebration, and the crowds were currently enjoying an outdoor concert and other festivities. police estimated the afternoon's crowd at the fairgrounds at approximately , . there was a breeze blowing westward at miles/hr, cooling the fairground crowd slightly and making them a little more comfortable. tens of thousands more were en route to anytown for the evening's celebration via the major highways, including i- , i- , and i- . there was heavy freeway congestion at this hour outside downtown anytown. warnings from the department of homeland security had been issued for vigilance during the july holiday weekend, but the nature of this terrorist threat had been nonspecific, and the nation had been at a u.s. terror alert level of code yellow on this july holiday. it was estimated that , of the , people at the fairgrounds this afternoon were attending the concert. about min into the show, a man driving a white van on any parkway suddenly stopped at the main entrance to the fairgrounds, about yd from the concert venue. ten seconds later the van exploded in a massive fireball, the blast hurling fiery shrapnel into the crowd. the explosion killed people instantly and injured , more in the adjacent crowd, and the blast could be heard over a -mile radius. smoke emanating from the resulting fire was visible to motorists on the congested freeways and roads leading to the fairgrounds. within moments of the blast, thousands of people began fleeing from the fairgrounds. motorists hearing the blast and seeing the smoke from area freeways and roads began to use their cell phones simultaneously by the thousands. cellular phone systems rapidly became flooded. on monday, july, an associated press wire bulletin surfaced that three moisture density gauges-each containing mci cesium- -were first reported missing that morning from a construction site on maryland's eastern shore. the site manager said the gauges were last seen on july, the day before the construction crew left the site for the extended holiday weekend. given this new information, public safety authorities had a high index of suspicion that this terrorist blast may have been caused by a "dirty bomb" containing the cesium- from the eastern shore construction site. environmental sampling revealed elevated radiation levels at the site of the explosion, consistent with this hypothesis. in the several weeks after the attacks, emergency rooms noted a surge in patients coming in for anxiety-related symptoms. area pharmacies were flooded with prescriptions for anxiolytic and antidepressant medications. community mental health services were being strained as anytown citizens attempted to come to grips with the horror of this terrorist attack. many residents of anytown stated they would never return to the city again because they believed the area would never be adequately decontaminated. questions. what are the potential environmental impacts of a dirty bomb? what can be done to prepare for and respond to such impacts? how would local, state, and federal public health and partner emergency response agencies work together in this scenario? what steps would be taken to distinguish a dirty bomb vs. from another type of explosion? what steps would be taken to evacuate, contain, and decontaminate the affected area? would evacuation involve all of anywhere county? who would take the lead in communicating timely, accurate information to the public on radiation terror before, during, and after this event? what would the crisis-and consequence-phase mental health service responses be to an attack on anytown by a "dirty bomb"? what steps, if any, could have prevented this attack from occurring or could have reduced the number of deaths and injuries? the haddon matrix. the field of injury prevention has long provided solution-oriented models for understanding threats to the public's health. industry and public health officials alike have applied these models to reduce morbidity and mortality from a variety of injury types. the haddon matrix, developed by william haddon, has been used for more than two decades in injury prevention research and intervention. the haddon matrix is a grid with four columns and three rows. the rows represent different phases of an injury (preevent, event, and postevent), and the columns represent different influencing factors (host, agent/vehicle, physical environment, social family and social support in aftermath of event environment). table illustrates a basic application of the haddon matrix to pedestrian traffic safety. the host column represents the person or persons at risk of injury. the agent of injury impacts the host through a vehicle (inanimate object) or vector (person or other animal/organism). physical environment refers to the actual setting where the injury occurs. sociocultural and legal norms of a community constitute the social environment. the phases of an event are depicted on the matrix as a continuum beginning before the event (preevent), the event itself (event phase), and sequelae of the event (postevent phase). the terminology used for the factors of the matrix can be adapted for different contexts; for example, "agent" may be more appropriate than "vector" in certain cases, and "organizational culture" might be used in addition to or instead of "social environment" (tables - ) when focusing on an institutional context. through its phase-factor approach, the haddon matrix meshes concepts of primary, secondary, and tertiary prevention with the concept of the host/agent/environmental interface as a target for delivering public health interventions (runyan ) . each cell of the matrix represents a distinct locus for identifying strategies to prevent, respond to, or mitigate injuries or other public health challenges (runyan ) . by dissecting a problem into its dimensions of time and contributing factors, the haddon matrix can be applied as a practical, user-friendly interdisciplinary brainstorming and planning tool to help understand, prepare for, and respond to a broad range of public health emergencies (runyan ) . the haddon matrix and new readiness challenges for public health. as an integral component of homeland security in the post- september environment, the public health infrastructure faces new and significant challenges of recognizing and responding to article | haddon matrix and public health response planning environmental health perspectives • volume | number | may a broad range of intentional and naturally occurring large-scale threats. furthermore, since the anthrax attacks of , the concept of public health emergency preparedness in the united states has evolved and expanded from a bioterrorism focus to an all-hazards readiness and response model. the all-hazards approach means that the infrastructure and skill sets used to prepare for and respond to a bioterrorism event can also be applied to a wide spectrum of current and emerging natural and intentional threats to the public's health, ranging from an infectious disease outbreak to a weather-related disaster. effective public health emergency preparedness and response requires appropriate preevent, event (crisis phase), and postevent (consequence phase) activities. in the context of emergency readiness, preevent activities include risk assessment, risk communication, and primary prevention efforts (e.g., preevent vaccination). event-phase public health activities involve crisis risk communication and community-based medical interventions such as postexposure prophylaxis and treatment, crisis mental health counseling, and isolation/ quarantine measures. postevent activities involve consequence-phase disaster mitigation and treatment of longer-term physical and mental health sequelae, along with ongoing risk communication and recovery efforts. table presents a conceptual overview of public health emergency preparedness and response activities and competencies and how they might be illustrated using the haddon matrix. items with asterisks on table are cdc-adopted emergency preparedness competencies for all public health workers developed by the columbia university school of nursing center for health policy ( ) . this highlevel view of the issues faced by those preparing for emergencies demonstrates the multidimensional flexibility of the haddon matrix. each phase of a public health emergency presents a unique set of demands on health departments in their readiness and response efforts. allocating resources for these phases is a significant challenge in the face of competing public health priorities and resource demands. these preevent/event/postevent phase challenges and the organizational flexibility requirements of an all-hazards response model can quickly become overwhelming for public health departments. by breaking a larger problem into smaller, more manageable components, the haddon matrix provides a practical, efficient decisionmaking and planning tool that health department leaders can use to better understand current and emerging threats, perform vulnerability assessments, prioritize and allocate readiness and response resources, and maintain institutional agility in responding to an array of public health emergencies. health department leaders can use the haddon matrix as a planning instrument to dissect the required preparedness and response requirements for any public health emergency scenario, and then strategize to meet these requirements using a "divide and conquer" approach. once the haddon matrix has been filled in for a given type of emergency, the cells of the completed matrix comprise specific preevent, event, and postevent task-oriented items that leaders can assign to appropriate staff to optimize their agency's readiness and response. some of these items within the completed haddon matrix may be more responsive than others to public health prevention and intervention, or may represent more pressing needs for a given community; this allows health department leaders to prioritize these assigned tasks based on the health department's unique demands and resources. the haddon matrix can also serve as a helpful after-action evaluation tool to assess a health department's performance in achieving the goals of a preparedness exercise, or in responding effectively to a real-life event. in this context, the tasks within each cell become items for performance evaluation that can contribute to an effective, comprehensive after-action report. a view of readiness challenges through the lens of the haddon matrix also promotes efficient use of public health resources, because the matrix can reveal strategies that allow multiple issues to be addressed by one solution. for example, the logistics of trying to anticipate every possible source of attack or emergency are staggering and impractical. the establishment of an effective incident command system and flexible emergency operations plan within a health department facilitates a more effective response regardless of the emergency. through the use of the haddon matrix, it becomes much more likely that public health departments will be able to maximize their readiness efforts, because policies and procedures that are identified as clearly beneficial in multiple scenarios can be developed ahead of less generalizable efforts. the haddon matrix also promotes efficient resource allocation by focusing on appropriate phase responses. because the matrix requires the user to follow issues across all of the phases of an event, problems that seem insurmountable during one phase might have ready solutions in a different phase. for example, the logistics of adequately sheltering a population upon the release of an infectious disease become much more manageable with a "preevent" educated population that understands the concepts of sheltering in place, emergency supply kits, and resources for additional trustworthy information. the model shows considerable flexibility as a tool to address threats-both intentional and unintentional-that face public health departments in their efforts to enhance public health readiness and response. from sars to dirty bombs, the haddon matrix reveals itself as a useful public health readiness tool for tackling difficult public health emergencies. of a naturally occurring public health epidemic that can be better understood and addressed via the haddon matrix. from diagnosis, to treatment, to infection control, to risk communication, sars is an infectious disease that exacts significant stress on multiple facets of the public health infrastructure (affonso et al. ; gostin et al. ) . a myriad of public health response issues surround a sars outbreak. table shows an example of the haddon matrix as applied to one such issue: sars hospital infection control. this sars model of the haddon matrix views infectious disease as a form of injury affecting the population on a broad scale. the model allows its users to better understand the multidimensional nature of the epidemic and to identify targets for prevention, mitigation, and intervention. by identifying targeted points of intervention (noted with asterisks in table ), we can discover potential measures to successfully mitigate the public health threat before, during, and after a sars event. considered in the event of an emerging infectious disease outbreak such as sars (loutfy et al. ; svoboda et al. ) . lessons on public health readiness are often learned painfully after large crises, as was the case during the sars outbreak of (campbell ; hearne et al. ). using the haddon matrix before an event occurs allows us to consider the interplay of variables that might otherwise have been missed (and were missed during the actual events associated with the sars outbreak). for example, in the preevent phase under physical environment, the haddon matrix reveals the importance of addressing the need for adequate personal protective equipment; this may seem obvious enough in hindsight, but this issue received insufficient attention before the sars outbreaks in (campbell ; reznikovich and balicer ) . equally important, the model is flexible enough to allow for big picture analysis of a situation, or a more focused analysis of the smallest units of study, including individuals. as a tool to understand, prepare for, and respond to sars, the haddon matrix thus reveals itself as a highly adaptable model. "dirty bomb" preparedness and response: a haddon matrix analysis. from a public health emergency readiness standpoint, the haddon matrix's adaptability also extends to environmental impacts of nonbiologic origin. radiation terror preparedness, for example, is a significant challenge in the emerging allhazards public health readiness framework, because the physical and mental health impacts of radiation terror on an affected area can be profound and long lasting. radiologic dispersal devices ("dirty bombs") are examples of radiation terror that present a challenge for homeland security because of their simplicity and relative ease of acquisition. dirty bombs are conventional explosives bundled with ionized radioactive sources, and remain a front-line terrorism preparedness concern in the post- september era (zimmerman and loeb ) . applying the haddon matrix to the threat of a dirty bomb illustrates the value of this injury prevention model as a public health readiness and response tool, even when focusing exclusively on environmental issues. table shows how the haddon matrix can be applied to address environmental health issues related to dirty bombs. although the human, agent, physical, and social factors are numerous, a closer look reveals a more specific set of points for targeting environmental assessment and intervention (table ) . like the haddon matrix for sars in table , the haddon matrix for dirty bombs in table reveals the host, social environmental/ organizational culture, and selected physical environmental dimensions as major points of impact for public health assessment and intervention (noted with asterisks). hazardous materials (hazmat) and other first-responder agency personnel would comprise the front lines at the scene of a dirty bomb event, rather than health department workers. nonetheless, a comparison between the dirty bomb and sars haddon matrix examples shows marked similarities in the importance of risk communication, mental health support, resource use, surge capacity, and effective surveillance as points of public health impact, consistent with an all-hazards readiness and response framework. table reveals that from an environmental perspective, modifiable public health "impact" opportunities for dirty bomb preparedness and response involve mainly organizational culture/ social environment factors, as well as a few host and physical environment factors. the legal and regulatory aspects of environmental remediation after a dirty bomb are critical public health issues with significant economic implications (elcock et al. ) ; these are also reflected in table as "impact" opportunities on the haddon matrix. collectively, these modifiable host, physical environment, and social environment/ organizational culture factors represent targets for streamlining readiness and response activities; addressing the safety, risk perception, and mental health needs of first responders and hazmat personnel; and managing the financial resource and response issues of a dirty bomball of which are critical pieces in dealing with the environmental impacts of a dirty bomb. the applied examples of sars and dirty bombs illustrate the utility and flexibility of the haddon matrix as a tool for understanding, preparing for, and reacting to a spectrum of intentional and naturally occurring public health threats. following the principle that "all disasters are local," the haddon matrix can provide a tool for public health agencies to address specific gaps and requirements that must be filled to meet their communities' unique readiness needs. additionally, the haddon matrix can serve as a helpful model for disaster preparedness and response in a variety of contexts, from public health readiness policy development to local public health practice emergency response planning. as an effective creative brainstorming and planning tool, it is ideally suited to facilitate tabletop preparedness exercises at health departments in cooperation with partner firstresponse agencies. it can assist in needs assessment efforts for public health agencies and their stakeholders. it also can serve as a valuable classroom aid in teaching public health readiness concepts at the secondary and graduate school levels, helping future public health leaders to develop critical problem-solving skills needed to tackle difficult readiness challenges. these examples and their potential applications highlight five essential features of the haddon matrix as a tool for public health emergency readiness and response. first, the haddon matrix provides a framework for understanding a terrorism incident in a temporal context, including its preevent, event (crisis), and postevent (consequence) phases. second, it can effectively dissect these temporal phases of a public health event into their contributing factors. third, it can aid in a public health agency's vulnerability assessment of its preparedness and response capacities. fourth, it can provide health departments with a useful framework for developing these capacities to deliver a prioritized, targeted approach to the public health dimensions of terrorism prevention and response. fifth, it is a sufficiently flexible analytic tool to aid health departments in addressing virtually any type of intentional or naturally occurring public health emergency. the dissection of sars and dirty bombs by the haddon matrix reveals how widely disparate public health challenges can be tackled by a user-friendly and efficient injury prevention conceptual model. a renewed look at the haddon matrix thus shows this tool to be a vital link between public health preparedness and injury prevention science. the urban geography of sars: paradoxes and dilemmas in toronto's health care the sars commission interim report: sars and public health in ontario bioterrorism and emergency readiness: competencies for all public health workers establishing remediation levels in response to a radiological dispersal event (or "dirty bomb") ethical and legal challenges posed by severe acute respiratory syndrome: implications for the control of severe infectious disease threats sars and its implications for u.s. public health policy: "we've been lucky the canadian experience with the sars outbreak-israeli lessons to be learned using the haddon matrix: introducing the third dimension introduction: back to the future-revisiting haddon's conceptualization of injury epidemiology and prevention public health measures to control the spread of the severe acute respiratory syndrome during the outbreak in toronto dirty bombs: the threat revisited. defense horizons the development of this manuscript by johns hopkins center for public health preparedness was supported in part through a cooperative agreement u /ccu - with the centers for disease control and prevention.the authors declare they have no competing financial interests. key: cord- -wbp ykwu authors: warren, adam; bell, morag; budd, lucy title: model of health? distributed preparedness and multi-agency interventions surrounding uk regional airports date: - - journal: soc sci med doi: . /j.socscimed. . . sha: doc_id: cord_uid: wbp ykwu the liberalisation of the european aviation sector has multiplied paths of entry into the united kingdom (uk) for the international traveller. these changing mobilities necessitate a reconceptualisation of the border as a series of potentially vulnerable nodes occurring within, and extending beyond, national boundaries. in this paper, we consider the border through the lens of port health, the collective term for various sanitary operations enacted at international transport terminals. in the uk, a critical player in the oversight of port health is the health protection agency (hpa), which became a non-departmental public body in . a major part of port health is preparedness, a set of techniques aimed at managing, and responding to, emergencies of public health concern. more recently, certain jurisdictions have embarked on public health preparedness work across a number of different geographical scales. using methods pioneered by the military, this form of ‘distributed preparedness’ is of increased interest to social science and medical scholars. with reference to case studies conducted in localities surrounding two uk regional airports following the – h n influenza pandemic, we consider the extent to which distributed preparedness as a concept and a set of practices can inform current debates - in the uk, and beyond - concerning interventions at the border ‘within’. at a time when global outbreaks of severe acute respiratory syndrome (sars) and h n pandemic influenza have coincided with regulatory and structural changes within the united kingdom (uk) aviation industry, the challenges of safeguarding public health have been exacerbated. scholars have long considered international air, rail and sea ports as potential sites of entry for threats to human health (gushulak & macpherson, ; katz, staiti, & mckenzie, ; meyers, ) . however, recent transformations of individual mobility brought about by more diffuse air travel have highlighted the existence of multiple 'borders within' states through which an infectious disease may enter or leave a country (budd, bell, & warren, ). an emerging literature considers the concept of 'preparedness' (collier & lakoff, ; ingram, ) , which e unlike other anticipatory actions such as pre-emption and precaution e aims to stop the effects of an event from 'disrupting the circulations and interdependencies that make up a valued life' (anderson, : ) . in the united states (us), collier and lakoff have drawn attention to the development of 'distributed preparedness', an 'organizational framework and set of techniques for approaching security threats' across a number of geographical scales ( : ). the practices associated with it include: the coordination of planning and response interventions across a number of public and private actors; mapping the vulnerability of vital systems to a potentially catastrophic event; and the use of scenarios to test joint working amongst local, regional and national agencies. this paper argues that there is scope to explore the meaning of distributed preparedness both in the uk and in relation to managing the global threat of infectious disease. we focus on the airport as a key node for entry and exit, and examine the concept of distributed preparedness as a series of measures put in place to enable the management of changing patterns of infectious disease spread. the paper builds on international research from the social sciences and epidemiology, and makes reference to official, 'grey', literature, to conduct an empirical examination of distributed preparedness interventions in geographical locations surrounding selected international airports in the uk. we draw on in-depth interviews conducted with emergency planners, environmental health officers and healthcare practitioners employed by airports, local authorities, primary care trusts (pcts) and health protection units (hpus) in order to analyse the multi-agency interactions that were in play during the e h n pandemic influenza outbreak. in conclusion, we highlight three ways in which our empirical research develops conceptions of distributed preparedness to inform the management of an emerging infectious disease outbreak at the 'borders within' the uk. progressive liberalisation of the european air transport sector during the last two decades has resulted in a dramatic increase in international air traffic in the uk, particularly at smaller regional airports that historically handled few (if any) international flights (budd et al., ) . in europe, a series of measures, beginning in the early s, allowed new airlines to enter the marketplace and airport operators to engage in more effective competition. the reforms dissolved traditional bilateral and multilateral air service agreements that specified which airlines could fly individual routes, the frequency with which the services could operate, the airports that could be served, and the airfares that could be charged (goetz & graham, ) . one, arguably unintended, consequence of the sudden 'opening up' of regional airports in europe (maertens, ) to regular long-haul services has been the dramatic increase in the number of sites through which potentially infected travellers and unwanted pathogens can enter or leave a country. in , fewer than scheduled international destinations were served from uk regional airports, but by the figure had increased to over , with particularly significant growth occurring at liverpool, bristol and east midlands (caa, ) . while the majority of international flights at uk regional airports are short-haul european services, many of these airports e crucially, from a public health perspective -also now support a significant number of longhaul 'spoke', or feeder, services to airports in the eastern united states, the middle east, and the indian subcontinent (budd et al., ) . these services, combined with the growing number of transfer passengers they carry, have significant implications for public health provision and border control in the uk by both compounding and also obfuscating the geographical complexities of individual journeys. we argue that this has fundamentally altered the spatiality of port health provision in the uk and exacerbated the challenges of discharging effective health security safeguards at every new point of entry in the uk. practices of sanitary pre-emption and preparations at uk airports are, of course, not new. indeed, there has been a dedicated health control unit at london heathrow since to handle the health risks posed by international aeromobility. moreover, considerable scholarly work evaluates the role of air travel in the spread of infectious disease (ali & keil, ; gerard, ; warren, bell, & budd, ) . the threat posed to a nation's health by global infectious disease has been widely theorised as 'biosecurity', a concept given to various technical and political efforts that aim to safeguard human, animal and plant health (for example, hinchcliffe & bingham, ). yet, although such academic work has sought to understand the various forms of expertise and practices through which particular disease threats are identified, articulated, and managed, there has arguably been less focus on the preparations undertaken to manage the spread of human pathogens in the localities surrounding airports and the social relationships that result from this process. we contend that contemporary disease preparedness, which increasingly involves the study of individual airline passengers' mobility, is creating new geographies of containment and control which often begin before a passenger enters an airport and continue long after their arrival at their final destination (warren et al., ) . the significance of these geographical divides in determining health interventions, and the practices of control that occur within these settings, have been increasingly researched over the last decade, resulting in a burgeoning literature on 'border health' (barnes, ; monk, manning, denman, & cornejo, ) . whilst the study of sanitary control at geopolitical borders is important, we wish to consider preparedness practices resulting from significant spatial realignments within the uk following the liberalisation of the european aviation industry, and the implications for the social and professional relationships within and between the affected organisations. borders are increasingly being extended to nodes within national territories beyond the major international airports and, of particular significance to this paper, they are entering the localities within which these airports are situated. accordingly, we aim for a more nuanced understanding of the border 'within', recognising that borders are not just 'abstract lines on maps, but a set of practices on the ground' (bashford, : ) . building on this statement, we focus on 'new' international airports 'within', as sites exposed to infectious disease threats. increasingly, theoretical and empirical literature has identified the airport as a site in which mobile bodies can be mapped and through which infectious diseases may enter a country (adey, ; st michael's hospital, ; warren et al., ) . for example, the bio.-diaspora project, undertaken by a team of canadian researchers and medical practitioners, examined the airport as a point of vulnerability and as one which exposed the nation to infectious disease threats (st michael's hospital, ). yet, although that study considered the extent to which public health preparedness may be strengthened to manage these threats, it gave little detail on the types of intervention to be enacted at these sites. gaber, goetsch, diel, doerr, and gottschalk ( ) have developed detailed guidelines for entry and exit screening at international airports, arguing that infectious disease transmission is more likely to occur at the airport before or after, rather than during, the flight. therefore, a flexible approach is required in relation to community mitigation measures, corresponding to 'specific characteristics of individual biological agents' (gaber et al., : ) . according to dickmann et al. ( ) , risk communication forms an integral part of these interventions. in particular, attention should be paid to the provision of information to inbound and outbound passengers and to airport staff, taking account of their different needs (dickmann et al., ) . these contributions, whilst important, focus on major points of entry as opposed to expanding regional airports. in this paper, we seek to place the theoretical debate on border health in the context of recent and ongoing changes in the uk aviation sector and developments in pandemic preparedness planning at the local scale. the growth of international services at uk regional airportsand the resultant re-siting (or localisation) of the national border within uk territory -has resulted in a dispersal of public health protection interventions. regional airports are particularly vulnerable as, following liberalisation of the uk aviation industry during the s, they handle increasing volumes of international air travel, and hence become part of the re-situated border. at uk airports, a framework of preparedness has been established in which the response to potential, health-related, emergencies is one of port health. port health is the collective term for the management of health activities at international transport terminals under various public health regulations. it aims to manage health risks associated with the movement of people and goods through air, sea and rail ports (hpa, : ) . the resultant practices are overseen by the uk health protection agency (hpa) across national, regional and local scales, and enacted in localities by various public, private and voluntary sector agencies. significantly, the appointment of port medical officers (pmos)medically-qualified staff responsible for communicable disease control at ports e is the responsibility of local authorities (hpa, ) . other partners include local police, general practitioners, airline and airport staff, pcts, and national security and immigration services (for example, private security contractors and the uk border agency (ukba)) (hpa, ) . internationally, the hpa's interventions at these sites are informed by the regulatory framework set out by the world health organization's (who's) international health regulations (ihr) (who, ) . moreover, guidelines for managing communicable disease spread at airports have been developed by industry bodies such as the international civil aviation organization (icao) (icao, ) and airports council international (aci) (aci, ). in england, health controls on aircraft and at airports are contained within three statutes: public health (aircraft) regulations , the public health (control of disease) act and the public health (aircraft) (amendment) (england) regulations . the regulations define the measures that should be taken at airports with respect to arriving and departing passengers, crew, and aircraft to limit any potential risks to public health and reduce the spread of infection. these interventions include the medical examination of potential entrants to the uk, the grounding of aircraft and, if required, the detention of passengers, crew, cargo, and equipment until local health authorities are satisfied that no disease threat exists (hpa, ) . at this juncture, there is a need to analyse critically the extent to which this existing framework of preparedness -potentially under threat -works in practice. to achieve this, we draw on the concept of distributed preparedness, examining recent uk initiatives aimed at improving local interventions during a particular event -the e h n influenza pandemic. distributed preparedness considers preparedness interventions enacted across a number of geographical scales within a state's territory. the majority of work in this field has been conducted in the us, where distributed preparedness has been described as 'the development of an organizational framework and set of techniques for approaching security threats' (collier & lakoff, : ) . its antecedents are located in the broader post world war two civil defence planning, where it was developed to counter the possibility of nuclear attack. in this context, it 'presented a new model of coordinated planning for catastrophic threats', with a spatial focus on interventions utilising resources and infrastructure situated in the locality, as well as nationally (collier & lakoff, : , ) . in recent decades, distributed preparedness work has broadened to consider domains such as floods, earthquakes, hurricanes, financial regulation and pandemic influenza (collier & lakoff, ; thompson, ) . although the system of governance in the uk clearly differs from that of the us, we argue that the distributed preparedness concept is instructive in the context of recent epidemiological and political developments. the former comprise not only the h n pandemic, but also outbreaks of sars and h n avian influenza earlier in the decade. these disease occurrences focused attention on measures enacted in specific localities against pathogens that could enter the country at multiple sites and the extent to which communities could prepare for 'biological 'unknown unknowns'' which may appear from anywhere and could have potentially catastrophic effects (braun, : ) . political developments include contentious reforms of uk healthcare provision by the conservative-liberal democrat administration which took office in may . although the scale, and pace, of implementation of these measures has been reduced following a public consultation during aprilejune , the changes will result in the abolition of the hpa in april and the transfer of its functions to the department of health (dh). moreover, from april , primary healthcare provision will be devolved to gp-led clusters, with current pcts ceasing to exist (dh, ) . this raises key questions over the location and nature of responsibility for the assessment and preparation of emergency response. in the uk, there has been a dearth of scholarly research into distributed preparedness measures enacted by civil authorities including airports, hpus, local authorities and pcts. this matters as their work came under considerable scrutiny in national and regional news outlets, and epidemiological journals, during the early weeks of the e h n pandemic (warren et al., ) . in this paper, we contend that the distributed preparedness practices of these organisations have affected conceptions of the border 'within', defining it as a geographically contested area. our evidence is based on analysis of the relations between these organisations at multiple sites across national, regional and local scales. networks of port health preparedness developed in localities surrounding uk regional airports during the second half of the last decade. these are represented diagrammatically in fig. . (see also table for an explanation of the acronyms for different agencies.) at a national level, in , the hpa, in conjunction with the dh and the home office, undertook a review of port health operations across england (hereafter 'review'). the review acknowledged the 'massive expansion in air travel' and sought to clarify local agency responsibilities in this domain, giving new authority to ports, especially in the regions, as part of the uk border (hpa, ) . the final report outlined various recommendations, including the need for closer working with las and pcts to ensure a port response to potential or actual public health threat and devise 'emergency plans for public health emergencies' (hpa, : ) . the review complemented other legal and policy measures. the civil contingencies act gave emergency planning a higher profile by establishing a framework requiring local responders (for example, emergency services, local authorities, nhs bodies, the hpa, the health and safety executive, transport and utility companies) to collaborate through one of 'local resilience forums' (lrfs) within england and wales (cabinet office, www, ). by may , every lrf in england and wales had developed a multi-agency pandemic influenza plan (cabinet office, www, ) . moreover, the cabinet office and dh, in november , produced a national framework for responding to an influenza pandemic (hereafter national framework), outlining central government's proposed response to an influenza pandemic, and seeking to 'inform the development of community and organisational arrangements' appropriate to local circumstances (cabinet office and dh, : ) . its actions included plans for a national pandemic flu service to enable symptomatic people to be treated at home, clear policies on maintaining open borders, and the need to keep under review the case for health screening at major travel nodes (cabinet office and dh, ; hine, : ) . our empirical work focused on the immediate localities surrounding two, expanding, regional airports, situated within different regions of england. the airports hosted direct flights to 'international' (i.e. non-european economic area (eea)) destinations and provided low cost scheduled and charter services within the eea. both airports supported a significant number of long-haul 'spoke', or feeder, services to airports in the eastern us, the middle east, and the indian subcontinent. the two airports were owned by separate organisations and, for reasons of confidentiality, the airports (and their surrounding localities) will be hereafter referred to as 'a' and 'b'. the empirical data presented in this paper was obtained from participants. they were selected on the basis of their job role, in particular, the extent to which it incorporated port health and/or emergency preparedness duties. on occasion, this presented difficulties, as individuals' responsibilities were not always clear from their job title. as a result, we communicated with identified persons prior to interview to ascertain the nature of their duties. we also acted on recommendations from previous contacts. the fieldwork was conducted over a four month period, from late april to mid-august . ethical approval for this study was received from loughborough university, and the research was undertaken in accordance with the university's code of practice relating to investigations on human participants (lu, www, ). the exact number of pcts and local authorities in each locality has been masked to avoid identifying the two case study areas. the interviewees comprised managers, researchers and practitioners based at the two airports and within the surrounding local authorities, pcts and hpus, as well as at an hpu serving a third regional airport and a regional public health observatory (refer table ). data were collected through semi-structured interviews. where it was not possible to interview participants, we compiled detailed questionnaires, which were sent electronically to the relevant individual. the questions, in the interview schedules and questionnaires, covered four general areas. data from both the interviews and the questionnaires are presented in this paper. first, the context to the existing port health and/or emergency preparedness work at the interviewee's organisation was established. in particular, we wished to understand more fully: participant role; whether the participant worked alone, or with colleagues within the organisation; and the history of the role, strategic responsibility for health protection at an english regional airport other than airports a and b. . administrator. responsible for collating statistical data to ensure the hpu fulfils its remit. regional public health observatory senior analyst. remit includes statistical and epidemiological analysis of public health data including any changes in remit affected during the term being served by the existing postholder. second, we considered collaborative working with external organisations across local, regional and national scales. potential partners included local authorities, pcts, hpus, strategic health authorities (shas), the department for health and the ukba. in this section of the interview schedule/ questionnaire, we asked questions about the history of any collaborative working and sought clarity on professional boundaries and organisational responsibilities. third, we investigated organisational port health and pandemic preparedness enactments in greater detail by asking questions relating to: (i) policies in these areas; (ii) steps taken to safeguard the local population against pandemic risk during the - h n influenza outbreak. fourth, we asked the participants to consider lessons learnt from the h n pandemic outbreak, and any other port health incidents. in addition, we sought their views on future challenges in relation to port health/pandemic preparedness. data analysis was conducted on interview transcripts and completed questionnaires. each text was independently assessed by two of this paper's authors to identify areas of significance for participants. key words and themes (for example, 'h n ', 'airport', 'preparedness', 'collaborative working') were highlighted. due to the relatively small size of the sample, this work was undertaken within microsoft word. the findings from our empirical research are discussed in the next section. case studies: distributed preparedness and the management of h n surrounding two regional airports both case study areas were considered representative of the new border 'within' and agencies located at these sites had, to varying degrees, worked on pandemic planning. with reference to the e h n outbreak, we briefly consider the international connectivity of the airports within each case study area, before discussing preparedness work undertaken by various local agencies and the extent to which it resulted in actions within their communities. airport a worked directly with one local authority (la), one pct and one hpu. however, the geographical areas for which these organisations were responsible varied enormously, with the hpu having both rural and urban pcts and over local authorities within its border. in the localities, interviewees in the organisations surrounding airport a were particularly conscious of their port health duties and were keen to detail the efforts they had made to develop a coordinated approach within their locality. for instance, the hpu port health lead in this case study area had established 'two or three years ago' a port health meeting, held every weeks. attendants at this forum discussed 'normal' (i.e. non-emergency) port health functions, for example, '.assessing the structures and partnerships in place, the funding available, how they had operated in the past, how they were going to operate in the future' (hpu, port health lead) this meeting replaced an informal network where people 'spoke to each other' but there had been, significantly, 'no formally appointed medical officers in place'. they had progressed to a situation where airport a had continuous pmo cover. the revised system had been tested by three incidents, two involving children with rashes ('suspected chickenpox') and the third concerning an adult passenger who appeared to be 'quite drowsy' and 'unresponsive'. in these cases, standard procedure involved the airline pilot radioing in to the airport terminal duty manager, who in turn telephoned the hpu, using a specific contact number. this system of a single point of contact at each port -a recommendation of the review -had been in place in case study a for 'two, maybe three' years. only one of the three incidents (the first suspected chickenpox call) resulted in a direct intervention at the airport, a 'high level' response which the interviewee implied was unnecessary and, ostensibly, due to the 'inexperience' of the hpu practitioner who took the call. this view on the general robustness of port health procedures in the particular locality was shared, to varying degrees, by the partner organisations interviewed. airport a and the neighbouring la were trenchant in their support for the port health measures. at the same time, a deputy director based at the pct in direct contact with airport a stated that, whilst his organisation 'did not have formal responsibility for port health', it would be 'as helpful as it can' during port health incidents, providing 'surge capacity when necessary' in the form of additional staff, including district nurses. the provision of relief staffing was perceived by the interviewee to be one of the significant port health challenges faced by the pct. with respect to airport b, the organisational geographies were more fragmented than those surrounding airport a. like airport a, airport b also worked directly with one la, one pct and one hpu. yet, the hpu incorporated a higher number of pcts, and a similar number of local authorities, within its geographical border. it was perhaps as a consequence of this that there appeared to be less understanding amongst interviewees of the port health procedural set-up in this locality. whilst interviewees at one pct within the locality were clear that port health was the hpu's role, they openly admitted that as an organisation they were 'not fully aware of where [their] responsibilities lie' in this area. although clear measures were in place for emergencies such as crashes, fires, and hijacks, the pct was: .not aware of any formal arrangement to provide for a health response if a disease entered the country, or aware of any documentation outlining a pct response or what the lines of communication were with [airport b] and the hpu (pct manager, airport b) in addition, anxiety about risk communication was expressed by the airport, with a manager stating that they were 'not as sharp on health as we could be'. nevertheless, the airport's designated port contact, an experienced environmental health officer employed at an la, demonstrated full awareness of port health procedures whilst expressing unhappiness at his organisation's reduced port health role. indeed, port health did not appear to be as high a priority in this locality as in case study a. the hpu port health lead for case study area b reported that there was 'very little' going on in the locality in terms of port health, cautioning, somewhat surprisingly, that their organisation only served one 'small' airport. these divergences in opinion over the effectiveness of (and even the need for) localised port health interventions -with some organisations even questioning their own capabilities in this domain -is indicative of some of the nuances that exist in recent distributed preparedness initiatives. we now examine the distinctions that existed within these spatial networks with respect to the e h n influenza pandemic. the presence of the h n influenza virus was confirmed in both case study regions by the second week of may . by this stage, human-to-human transmission was occurring in many parts of the uk. the geographical spread of the virus was later described by dame hine in her officially sanctioned, but independent, review of the uk response to the h n pandemic as 'unexpected' and 'far from uniform' (hine, : ) . some localities within the uk were disease 'hot-spots' whilst others were 'largely unaffected' (hine, : ) . as the pandemic was believed to have entered the uk via birmingham international airport, considerable media attention was focused in the early weeks of the outbreak at regional airports (warren et al., ) . interviewees at both airports reported that the multi-agency meetings -with local authorities, hpus, ambulance services, uk border agency, pcts and acute trusts -during this critical period were, in words of one senior manager, 'very useful'. within case study a, the relationship between airport and hpu appeared to be particularly close, with the same senior manager stating 'the liaison was very good, we've got contacts if we need them'. the hpu's role with regard to this airport was education (for example, delivering a presentation on the pandemic 'in layman's terms, and answering airport queries') and informative (providing leaflets to be given to passengers). yet, by july this activity had, according to a senior manager at airport a, 'faded a lot': 'the concentration wasn't on the airports anymore, it was on a much more national scale. so, we stepped back a bit from it.' (emergency planning manager, airport a) the initial work at the scale of the locality was led by the hpu, in collaboration with pcts and, to a lesser extent, local authorities. within case study a, the port health lead for the hpu had stressed their role in developing local networks of collaboration. nevertheless, it was stated that the 'burden' of the initial response 'fell on the resources of the hpu', who were involved in making up swabbing packs (to take samples from patients), advising on and following up treatments and 'doing databases and surveillance'. in the port health lead's view, the pct and the sha (responsible for regional oversight of pcts), in particular, 'weren't ready' during the early phase of the pandemic: 'basically, if we hadn't done it [led the initial response], the nhs would have fell on its face'. therefore, although the hpu did 'borrow' staff from the pct for routine work such as 'swabbing', the interviewee was clear about the hpu and, more widely, the hpa's leading role: 'the hpa [.] were working all hours for six to eight weeks until the primary care trust and everyone else got their systems sorted out.' (port health lead, hpu, case study a) the hpu response encapsulated the multiple geographical scales at play e a true indicator of distributed preparedness e that extended far beyond the locality. this is evidenced by this hpu's involvement in supplying data to the 'flight control hub' established by the hpa at a national scale as means of monitoring the uk's porous border with its many sites of intervention, by coordinating flights, giving advice and coordinating any follow-up of incoming travellers. this input was supported by the hpu port health lead negotiating with the hpa at a national level to ensure that 'small ports' are represented in their revised national pandemic plan. preparedness for the pandemic had been based on one scenario ('big bang, high mortality') which did not happen. this caused the hpa (nationally) and hpu (locally) to: '.work, from an operational delivery point of view, off plan, right from the very beginning. it was different to what people had envisaged.' (port health lead, hpu, case study a) this view was supported by the pcts and local authorities contacted. a senior manager (pct , case study a) stated that the main lesson from the e outbreak was that 'the plans had to be flexible'. a risk coordinator based at la in the same geographical area made a similar point, stating that a pandemic 'won't necessarily result in mass deaths' and that the one of the biggest issues was surrounding human resources and potential staff absences during the outbreak. our fieldwork suggests that the pcts, possibly due their management structure and accountability to the dh, believed they were given little autonomy in reacting to the unexpected nature of the pandemic and its consequences for the populations within their localities. pcts in both case study areas complained about the dh's 'interference' in their work. an interviewee in case study b stated: '.we have had a pandemic preparedness plan which we spent two years developing and then the dh binned it out in one day [.] instead of allowing the pct to manage it locally, they took complete control of the management of the pandemic.' (risk manager, pct, case study b) the interviewee believed this was the experience of pcts throughout the country. indeed this point was made by a senior manager at pct in case study area a, who drew attention to the dh 'changing the rules', for example, by announcing that responsibility for managing cases to go to general practice (something that was not in any plans) and for the 'shambolic' lead-up to the national pandemic flu service, the national telephone and online influenza service. moreover, at the start of the outbreak, the dh purportedly redefined the stages of the pandemic: 'they [the dh] straight away brought in these two phases, the containment phase and then the treatment phase, which had not been included in any of the guidance, or anything like that, that had been sent out over the two years that all pcts and health trusts had followed religiously in drawing up their plans.' (risk manager, pct, case study b) viewed from this perspective, distributed preparedness, whilst informing planning within localities, was barely enacted when the pandemic became a reality. it appeared to have been replaced by more prescriptive interventions from central government. this style of management was criticised by a senior public health official: 'the central leadership could be quite damaging locally because it was so detailed [.] it was 'you need to do this, you need to do it like this' and it meant that there was an awful lot of time spent trying to clarify exactly what it was they wanted.' (senior manager, pct, case study b) in addition, confusion was caused by the algorithms issued by the dh and intended to be applied when, for example, issuing antiviral drugs. the resultant requests for clarification -from the pct and gps -took up considerable time, diverting resources away from serving the community at large. at the same time, pcts in both case studies acknowledged intrinsic weaknesses in their preparedness planning. one key lesson, according the senior manager at pct , case study a, was that plans had to be 'flexible'. the pct interviewees in case study b concurred, stating that existing plans contained a lot of detail, such as 'how to set up a mortuary', that has not proved to be as useful. with hindsight, it would have been better: '.keeping things fairly generic, so that you can develop something more detailed if you need it but keeping it as flexible as possible [.] . the plans were not hugely useful, certainly not the original ones.' (senior manager, pct, case study b) moreover, preparedness interventions were, to a lesser degree, hampered by tensions between organisations within the locality. whilst it should be stressed that participants did, generally, view their working relationships with other agencies positively, some disputes did exist. for example, the hpu in case study b, apparently stretched by having to act in a reactive capacity across a large geographical area comprising several pcts, asked the pct participating in this study to free up its gps to assist in swabbing of patients. the senior manager interviewed stated that whilst the pct was happy to assist the hpu during the containment phase, which aimed to restrict the spread of the virus, it was less prepared to continue to do so during the treatment phase, where laboratory confirmation of the virus was no longer required in order for patients to receive any necessary nhs treatment. this resulted in 'a bit of conflict' with the hpu, with the senior pct manager adamant that, in such circumstances, swabbing would have been 'a waste of [the pct's] time'. finally, the changing roles of the organisations interviewed and, in particular, the healthcare reforms announced by the incoming conservative-liberal democrat coalition government, informed the views of some participants on preparedness planning for future pandemics or other emergency planning processes. a senior manager (pct , case study a) was concerned that healthcare provisions currently enacted by pcts may be devolved to organisations such as social enterprises and nhs mental health trusts not subject to provisions set out under the existing civil contingencies act. the diffusion of primary health care provision suggested in the white paper could, therefore, result in a more 'fragmented' response to future public emergencies. the port health lead at the hpu in the same case study area expressed concerns that the reforms were 'really going to change the organisational landscape': 'how do we reconfigure what we've developed over the last three years locally to make sure that we can provide this port health service to the port? [.] and that's going to be a major challenge. because we've only just got to where we've got within the existing organisations.' (port health lead, hpu, case study a) these concerns reflected, to some degree, the contested geographical landscape in which the various agencies operate, working to different remits across multiple scales, and the social relationships within those organisations. moreover, they reflected uncertainty about their future existence. the above interviewee, contacted prior to the announcement of the abolition of the hpa, was 'waiting to see where [their employer] was going to go'. another participant, a senior manager of an hpu outside of the two case study areas but also serving a regional airport, suggested the perceived independence of the hpa had helped it gain the trust of other agencies, making it easier to 'forge the right links with partners': '.there are some concerns that if we go into the dh that that element of independence might be compromised in some way and i think there is anecdotal evidence that a number of bodies have found it helpful to have the hpa as an arm's length body and giving independent advice.' (senior manager, hpu) in this paper, we have employed the concept of distributed preparedness to examine port health interventions enacted at the uk border. we built on previous work that reconceptualises this border as a series of potentially vulnerable nodes located inside the uk's state boundary. we refer to this reconceptualisation as the border 'within'. these nodes have emerged following air travel liberalisation, as regional airports -across the globe -increasingly host international flights (maertens, ) . we argue that these transformations in international passenger air travel have significant implications for the geographies of public health preparedness. moreover, these changing patterns of aeromobility have been complicated by uk government reforms, including the proposed devolution of many of the pct functions to multiple gpled consortia and the absorption of the work of the hpa into the dh. we draw attention to three ways in which our empirical research has clarified the complex notion of the border 'within'. first, our analysis uncovered tensions between organisational conceptualisations, and practices, of preparedness within localities. these tensions found expression in a degree of territoriality between agencies over their preparedness remits, where good practice required greater joint working and regular interactions between key players during 'normal' times. among some agencies, there was uncertainty over port health responsibilities, whilst specific actors were unwilling to compromise on what they interpreted as their professional roles. for example, the pct in case study b appeared unsure about the actions it should take in the event of an infectious disease entering its locality via the airport. during the h n pandemic, this perceived lack of effective formalised organisational port health procedures resulted in localised disputes over the extent to which the pct should provide nursing assistance to allow the hpu to conduct patient swabbing. in case study a, the tensions were less overt. nevertheless, the hpu port health lead for this locality, stated that their organisation felt the need to shoulder the burden during the early weeks of the h n outbreak: 'when this hit, [the pct] weren't ready to mobilise their resources, and we stepped in.'. second, the border 'within' was the focal point of preparedness planning, and interventions, across a number of geographical scales. there was evidence, nevertheless, of territorial competition between central and local control. preparedness plans made at the local scale, for example by a pct, frequently fed into multi-agency plans covering a larger geographical area, often a county or group of counties. this work directly linked to central government guidance, for example, the dh's national framework. conceptually, these proposed interventions, involving a number of agencies, were 'distributed' across various scales, from the town hall to government department. however, when the h n influenza pandemic occurred, this approach was not put into practice. instead, there appeared to be a lack of coordinated risk communication across agencies. in spite of the local and regional plans, central government e most notably the dh e took charge at a very early stage. agencies operating at a local level variously described the 'tearing up' of local plans and the 'changing [of] rules' (risk manager, pct, case study b). it was an approach that appeared to be antithetical to the changing nature of the uk border and the uneven geographical spread of the virus across the uk, identified in the hine report (hine, ) . whilst tensions between health policy formulations across geographical scales has been discussed elsewhere (mclafferty, ) , our empirical study captured the temporal changes, as a national government sought to exercise control from the 'centre' during a period of 'crisis' (anderson, ) . moreover, central government plans to administer directly the hpa's health protection role suggested that much work is required if distributed preparedness interventions are to be enacted during the next pandemic. third, we found that representations of the regional airport as a significant international border through which tens of thousands of non-eea travellers enter the uk each year (caa, ) did not register with the majority of participants operating within the communities surrounding this bounded geographical area. the director of the hpu in case study b referred to the airport within its boundaries, which handled in excess of , non-eea passengers a year, as 'small' ('it's not heathrow'). participants from other organisations also appeared to downplay the significance of the airport as a point of entry for disease, referring to the low number of port health cases identified each year and the general ineffectiveness of mass, pre-emptive screening processes. whilst reaction to the latter is understandable, in view of contentious screening interventions aimed at identifying diseases in the uk (tuberculosis) and in canada and parts of asia (sars) (ali & keil, ; hpa, ) , it is nevertheless surprising, given the means by which h n influenza was deemed to have entered the uk. following our investigation, and building on international studies on this topic (st michael's hospital, ), therefore, we call for a renewed focus on the regional airport (and on the origin of journey of international passengers), with a view to improving port health provision, both at the airport and within the surrounding community. this would help inform debates in other countries where international airports located outside of global cities have proved to be nodes for virus transfer. it was notable, for example, that the global spread of h n during e was facilitated as much through 'resort' and regional airports (cancun, mexico and birmingham, uk, respectively) as via major international sites (chang et al., ) . in order to be effective, any future preparedness interventions need to, in our view, pay greater attention to the bounded, and contested, geographies in which agencies serving these localities operate. moreover, they need to take greater account of the specific requirements of aviation and note the industry relevant guidance from international agencies such as the who, icao and aci. a more nuanced understanding of the tensions between local and national policy formulations in practice may result in more coordinated national e and transnational -approaches to 'distributed preparedness'. airport preparedness guidelines for outbreaks of communicable disease facing airport security: affect, biopolitics, and the preemptive securitisation of the mobile body global cities and the spread of infectious disease: the case of severe acute respiratory syndrome (sars) in toronto how well is the uk managing the influenza a/h n pandemic? preemption, precaution, preparedness: anticipatory action and future geographies paradoxes and asymmetries of 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diminishing impact of classical infectious diseases and new approaches for the st century securing life: the emerging practices of biosecurity the influenza pandemic: an independent review of the uk response. london: cabinet office port health and medical inspection review guidelines for states concerning the management of communicable disease posing a serious public health risk biosecurity and the international response to hiv/aids: governmentality, globalisation and security preparing for the unknown, responding to the known: communities and public health preparedness drivers of long haul flight supply at secondary airports in europe placing pandemics: geographical dimensions of vulnerability and spread famine relief and imperial policy in early modern morocco: the political functions of public health place, positionality, and priorities: experts' views on women's health at the mexicoeus border saint michael's hospital financial globalisation' and the 'crisis': a critical assessment and 'what is to be done airports, localities and disease: representations of global travel during the h n pandemic we are grateful for the very helpful suggestions we received from the social science and medicine senior editor (medical geography) and two anonymous reviewers. key: cord- - dfyjpid authors: sato, akiko; honda, kaori; ono, kyoko; kanda, reiko; hayashi, takehiko i.; takeda, yoshihito; takebayashi, yoshitake; kobayashi, tomoyuki; murakami, michio title: reviews on common objectives and evaluation indicators for risk communication activities from to date: - - journal: peerj doi: . /peerj. sha: doc_id: cord_uid: dfyjpid background: risk communication is widely accepted as a significant factor for policy makers, academic researchers, and practitioners in diverse fields. however, there remains a lack of comprehensive knowledge about how risk communication is currently conducted across fields and about the way risk communication is evaluated. methodology: this study systematically searched for materials from three scholarly search engines and one journal with a single search term of “risk communication.” the eligibility assessment selected peer-reviewed articles published in english that evaluated risk communication activities. emphasis was placed on articles published in recent years accounting for about half of the pre-selected ones. data on field of study, intervention timing, target audience, communication type, and objectives/evaluation indicators was extracted from the articles. patterns of objectives/evaluation indicators used in risk communication activities were compared with those of the definitions and purposes of risk communication stated by relevant organizations. association analysis was conducted based on study fields and objectives/evaluation indicators. results: the screening process yielded articles that were published between and in various fields, such as medicine, food safety, chemical substances, and disasters/emergencies. the review process showed that many activities were performed in the medical field, during non-/pre-crisis periods. recent activities primarily targeted citizens/non-profit organizations (npos), and was disseminated in the form of large group or mass communication. while “knowledge increase,” “change in risk perception and concern alleviation,” and “decision making and behavior change” were commonly addressed in practice, “trust-building” and “reduction in psychological distress” were rarely focused. the analysis also indicated that the medical field tends to perform risk communication at the individual or small group level, in contrast to the food safety field. further, risk communications in the non-/pre-crisis period are more likely to aim at “changes in risk perception and concern alleviation” than those in the crisis period. risk communications that aim at “changes in risk perception and concern alleviation” are likely to be presented in a large group or mass communication, whereas those that aim at “decision making and behavior change” are likely to be conducted at the individual or small group level. conclusion: an overview of recent activities may provide those who engage in risk communication with an opportunity to learn from practices in different fields or those conducted in different intervention timings. devoting greater attention to trust building and reduction in psychological distress and exploring non-citizen/npo stakeholders’ needs would be beneficial across academic and professional disciplines. the covid- pandemic made the world-from politicians, scholars and practitioners to individual citizens-desperate for accurate, timely information. as of june , there is no single day during which one does not hear updates or stories related to covid- . not only reliable information, but myths and false messages have also spread rapidly, causing great confusion. such incorrect information sometimes results in unnecessary fear or unrealistic hope among people (world health organization, a; shiloh vidon, ) . in response to the upsurge in demand from affected nations, the international federation of red cross and red crescent societies (ifrc), the united nations children's fund (unicef), and the world health organization (who) jointly issued the strategy (international federation of red cross and red crescent societies, united nations children's fund & world health organization, ) . the world is now keen on effective risk communication. although risk communication is now gaining tremendous attention, it is not new. in , the united states national research council published improving risk communication (national research council, ) and introduced an influential concept of risk communication by calling it: an interactive process of exchange of information and opinion among individuals, groups, and institutions. it involves multiple messages about the nature of risk and other messages, not strictly about risk, that express concerns, opinions, or reactions to risk messages or to legal and institutional arrangements for risk management (national research council, ) . the concept has been ardently applied to avert the occurrence of different risks in life and reduce their impacts on human health, property and the environment (fischhoff, ; covello & sandman, ; international risk governance center, ) . apart from public health emergencies such as covid- , risk communication can take place in other areas, involving health care, food safety, and chemical substances (glik, ; lopez-gonzalez the inclusion criteria used to select empirical studies were ( ) that the study evaluates risk communication activities in any field, and ( ) that the study is written in english. this study also included previous research that did not directly evaluate risk communication but did ask implementers, such as medical professionals, about the objectives and effects of their activities relevant to risk communication. these studies were included because they chemical substances organization for economic co-operation and development (renn & kastenholz, ) (cited covello, von winterfeldt & slovic ( ) ) the act of conveying or transmitting information between interested parties about (a) levels of health or environmental risks; (b) the significance or meaning of health or environmental risks; or (c) decisions, actions, or policies aimed at managing or controlling health or environmental risks. helping to build trust among organizations that risks are being adequately assessed and managed; assisting with making better decisions on how to address risks; helping to ensure smoother implementation of risk management policies; helping to empower and reassure the general public; helping to bridge the gap between real risks and perceived risks ; and helping to prevent crises from developing and managing them when they do occur. the process of informing people about potential hazards to their person, property, or community. to help residents of affected communities understand the processes of risk assessment and management, to form scientifically valid perceptions of the likely hazards, and to participate in making decisions about how risk should be managed. the exchange of information and opinions concerning risk and risk-related factors among risk assessors, risk managers, consumers and other interested parties. to enable people to protect their health from food safety risks by providing information that enables them to make informed food safety decisions , to facilitate dialogue and understanding among all interested stakeholders, and to improve the overall effectiveness of the risk analysis process. the interactive exchange of information and opinions throughout the risk analysis process concerning risk, riskrelated factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions. risk communication should: (i) promote awareness and understanding of the specific issues under consideration during the risk analysis; (ii) promote consistency and transparency in formulating risk management options/recommendations; (iii) provide a sound basis for understanding the risk management decisions proposed; (iv) improve the overall effectiveness and efficiency of the risk analysis; (v) strengthen the working relationships among participants; (vi) foster public understanding of the process, so as to enhance trust and confidence in the safety of the food supply; (vii) promote the appropriate involvement of all interested parties ; and (viii) exchange information in relation to the concerns of interested parties about the risks associated with food. european food safety authority (european food safety authority, ) to assist stakeholders, consumers and the general public to understand the rationale behind risk-based decisions and, to help them make balanced judgements about the risks that they face in their own lives. (continued on next page) effective risk communication can contribute to the success of a risk management program by: ( ) ensuring that consumers are aware of the risks associated with a product and thereby use or consume it safely; ( ) building public confidence in risk assessment and management decisions and the associated risk/benefit considerations; ( ) contributing to the public's understanding of the nature of a risk or risks; and ( ) providing fair, accurate, and appropriate information , so that consumers are able to choose among a variety of options that can meet their own ''risk acceptance'' criteria. ( ) improved understanding of the risks and benefits of regulated products by the multiple audiences with whom fda communicates, including relevant international audiences; ( ) increased public awareness of crisis events and the increased likelihood that affected individuals or groups will take recommended actions; ( ) increased public satisfaction with fda as an expert and credible source of information about regulated products; and ( ) increased confidence that target audiences are getting useful, timely information as it becomes available, to help them make informed choices. world health organization (gamhewage, ; world health organization, ) the two-way and multi-directional communications and engagement with affected populations. to share information vital for saving life, protecting health and minimizing harm to self and others; to change beliefs ; and/or to change behavior . (continued on next page) the exchange of real-time information, advice and opinions between experts and people facing threats to their health, economic or social well-being. to enable people at risk to take informed decisions to protect themselves and their loved ones. united states nuclear regulatory commission (persensky et al., ) an interactive process used in talking or writing about topics that cause concern about health, safety, security, or the environment. (examples listed:) ( ) providing information to the public about numerous issues, including inspection findings and their significance, changes to regulatory requirements, security and safeguards issues, or how the decisionmaking process works; ( ) to learn about stakeholder concerns, perceptions about risks, expectations about involvement in risk management decisions, or local information that will assist in risk analysis; ( ) building/restoring trust and relationships ; ( ) to ask stakeholders for input in a decision-making process ; and ( ) influencing people's behavior and perceptions about risk. risk communication provides the community with information about the specific type (good or bad) and magnitude (strong or weak) of an outcome from an exposure or behavior. typically, risk communication is a discussion of a negative outcome and the probability that the outcomes will occur. risk communication can be employed to help an individual make a choice about a behavior such as smoking, getting vaccinated, or undergoing a medical treatment. underlined parts correspond to indicators identified in this study. a = knowledge increase, = communication satisfaction, = change in risk perception and concern alleviation, = reduction in psychological distress, = trust building, = decision making and behavior change, = self-efficacy improvement. b translated by an author of this article (as). this study conducted two rounds of eligibility assessment. as it is briefly stated above, the first round was a review of only titles and abstracts of articles that were identified through the search engines and the journal of risk research. this initial assessment was to pre-select materials from which to derive the eligibility criteria for this study and to obtain a broad picture of recent risk communication activities in order to finalize a plan for subsequent analysis. the second round involved a review of full texts of pre-selected articles to confirm their eligibility. for the first round of eligibility assessment, the team established groups consisting of two researchers. each researcher independently assessed assigned articles and determined whether the study ( ) evaluated risk communication activities quantitatively, ( ) assessed the objectives and/or effects of risk communication activities qualitatively, and ( ) discussed the objectives and/or effects of risk communication activities based on prior experiences and/or existing scientific knowledge. for the second round, researchers were re-grouped, and a pair of researchers independently read assigned articles that they had not checked during the first round to confirm the eligibility of the articles and finalize the material selection. the principal investigator of the research project (mm) coordinated this evaluation and selection process. mm checked all articles and developed a basic protocol for the eligibility assessment. in general, if both reviewers who checked a particular article agreed in their evaluation of its eligibility, the decision was accepted. when there was a disagreement, mm facilitated discussions between the researchers to achieve consensus. when necessary, mm reflected the points of agreement in the protocols to ensure consistency in evaluation. after completion of the first round of eligibility assessment, the research team discussed what data should be extracted and how the information should be labeled and coded. the team made decisions based on characteristics of risk communication activities learned from the first round of eligibility assessment, the international and national organizations' statements on risk communication (table ) and other relevant literature, as well as individual researchers' experience and expertise. researchers remained in the same group formed for the second round of eligibility assessment, and separately extracted data from each assigned article and coded it as follows: • evaluation approach: ( ) quantitative, ( ) qualitative, and ( ) based on prior experience and/or existing scientific knowledge (see the criteria in ''eligibility assessment''). • study field: ( ) medicine, such as health and pharmaceutical realms, ( ) food safety, ( ) chemical substances (other than food safety matters), ( ) nuclear and radiological disasters/emergencies, ( ) other disasters/emergencies, ( ) climate change, and ( ) other. • timing when a risk communication intervention was implemented in line with the phases in the disaster management cycle: ( ) non-crisis or pre-crisis, including nonspecified, ( ) crisis, and ( ) post-crisis, including recovery phase. • target audience: ( ) citizens (e.g., individual citizens, residents, unspecified persons, and citizen groups) or non-profit organizations (npos), and ( ) other (e.g., government, professionals, and companies). • objective/indicator: ( ) knowledge increase, ( ) communication satisfaction, ( ) change in risk perception and concern alleviation, ( ) reduction in psychological distress, ( ) trust building, ( ) decision making and behavior change (e.g., risk acceptance, risk avoidance, and risk management, such as avoidance of unhealthy foods, seeking healthcare, disaster mitigation and preparedness, and community partnerships; attitude toward behavior and behavioral intention were also included in this category), ( ) self-efficacy improvement, and ( ) other. with regard to ''intervention timing'', this study employed the three-stage approach proposed by coombs ( ). the term ''crisis'' in this study refers to the definition proposed by the same scholar (coombs, ) as, ''a significant threat to operations that can have negative consequences if not handled properly.'' the pre-crisis period involves the detection of warning signs relating to such crisis and prevention and/or preparedness. the crisis period concentrates on identifying the onset of a crisis, controlling the situation, and minimizing negative impacts. the post-crisis period concerns rehabilitation and full recovery from the crisis, evaluation of crisis management, and better preparation for future crisis (coombs, ) . with regard to ''objective/evaluation indicator'', the researchers jointly determined how indicators should be classified by referring to the definitions and purposes of risk communication stated by the selected international and national organizations (table ) . where applicable, multiple response categories were selected. if both reviewers who checked a particular article classified it the same way, the decision was accepted. when the two researchers differed, discrepancies were evaluated by a third researcher. when needed, the issues were discussed with mm until all concerned researchers reached an agreement on the article's classification. examples of evaluation indicators were drawn for this paper. specifically, one example for each indicator was taken from the field of medicine, and another was from other fields due to the generally large number of relevant medicine-related articles. examples were chosen based on the frequency of citation assessed on may , through google scholar and the clarity of applied methods. even if some frequently cited studies targeted multiple indicators, they were referred to for only one indicator among all the applicable indicators. data was entered into a microsoft office excel spreadsheet. excel was used to compute descriptive information on the collected data. additionally, sets of pearson's chi-squared test with yates's continuity correction and fisher's exact test were conducted to examine the associations by study field and by objective/evaluation indicator. the statistical analyses were performed with studies that belonged to a single category of all the variables except for the variable of ''objective/evaluation indicator''. ''nuclear and radiological disasters/emergencies,'' ''climate change,'' and ''other'' from the study field variable were excluded because of their small size. for the same reason, the ''crisis'' group and ''post-crisis'' group were combined in the analysis on the associations by study field, and the ''crisis'' group was excluded in the analysis on the associations by objectives/evaluation indicators. for analyses involving study field, post hoc test (aoki, ) was conducted to determine where differences occurred if an initial analysis identified a significant difference between study field and other variables. r (r development core team, ) was used for the statistical analyses. test results were considered significant at p < . . p-value adjustment by holm's method was applied for multiple comparisons. the data generated for this study is provided in table s . the table contains basic information from all articles. figure shows a descriptive summary of the data. more than % of the studies quantitatively evaluated own risk communication practices. over % were related to medicine. studies classified as ''other'' included those addressing human-wildlife conflicts (lu et al., ) and traffic safety (feenstra, ruiter & kok, ; wu & weseley, ), as well as studies that used a risk scenario or involved multiple risk domains to investigate effective means or to assess intrapersonal and other factors of risk communication (dawson, johnson & luke, ; poortvliet & lokhorst, ) . five studies ( %) fell in multiple study fields. the vast majority of activities were implemented during a non-/pre-crisis phase ( %), and one study involved multiple phases. over % of the studies targeted citizens/npos. of those, studies or % also approached other target groups, such as medical professionals and farmers. as for communication type, more than % were communications to a large group audience or the public. of those, seven studies or % were also conducted in the form of individual/small group communication. frequently-used objectives/evaluation indicators were ''decision making and behavior change,'' ''change in risk perception and concern alleviation,'' and ''knowledge increase'' ( %, %, and %, respectively). examples of objectives/evaluation indicators are shown in table . the authors of this study identified ''knowledge increase,'' ''change in risk perception and concern alleviation,'' and ''decision making and behavior change'' as areas of focus in all fields; these objectives are also discussed in the definitions and purposes of most organizations and agencies (fig. , table ). here, ''knowledge'' is about the risks of concern and related risk management policies and actions. ''change in risk perception'' primarily focused on guiding individuals' subjective judgment of risk to align with available scientific evidence. this study assessed the relationships between health literacy, numeracy, and the ability to interpret graphs. participants were asked to interpret different types of graphs in the context of breast cancer risk and make hypothetical treatment decisions. interpreting the risk of a new breast cancer occurring in the other breast following preventive surgical options based on the hypothetical information from the provided graphs, making a surgical option, and describing differences in remaining risk between surgical options. chemical substances this study analyzed social transmission of risk information by examining how messages on the risk of a controversial antibacterial agent changed when being passed from one person to another in a chain of up to persons. information diversions and defects occurred while being transferred from one person to the next. this study evaluated the effectiveness of gain-and lossframed messages and visual aids about sexually transmitted diseases (stds) on participants' reactions to intervention material and their std-related risk perception, attitude, behavioral intention, and behaviors. participants' evaluation on how interesting, involving, and informative the intervention material was. food safety this study evaluated the effectiveness of a campaign on salmonellosis on public risk awareness and knowledge on risk and prevention behavior. participants' evaluation of the usefulness of the campaign material. nan et al. ( ) medicine this study investigated the impact of evidence-oriented messages and narrative-type messages about human papillomavirus (hpv) on recipients' risk perception and vaccination intentions. participants' perceived susceptibility to hpv. other disasters/ emergencies this study analyzed the influence of interpersonal discussions on residents' perceptions about the risks and benefits of the planned us national bio-and agro-defense facility. residents' perceived risk of negative impacts associated with the facility on their safety, health, and the environment. henneman et al. this study assessed the effects of the provision of graphs in addition to frequency information about breast cancer on at-risk women's risk understanding, psychological wellbeing, and intention to have breast screening. psychological wellbeing measured by an adapted version of the lerman cancer worry scale (cws) and the dutch version of the six-item version of the state scale of the spielberger state-trait anxiety inventory. macdonald gibson et al. ( ) chemical substances this study explored how probabilistic information influences risk understanding, opinions regarding risk/site management, risk perception, and concerns of residents who live nearby a closed site contaminated with unexploded ordnance. negative emotional reactions to the provided information: ''how (worried, afraid, anxious) would you be about (getting hurt if you worked at the site, letting children play near the site, living near the site)?'' trust building besser, anderson & weinman ( ) medicine this study conducted interviews with patients with osteoporosis and collected their drawings to assess their views on the illness and treatment, as well as their conditions. doctor-patient relationship was reported as one motivation to adhere to medication regimen. other (genetic engineering) this study introduced ''issues mapping'' to facilitate dialogues between different stakeholders, clarify different perspectives, and promote mutual understanding. it applied the techniques to social conflicts relating to genetic engineering issues. perceptions of genetic engineering including participants' trust in other stakeholders and their views on current debate in society. (continued on next page) medicine this was an intervention study to see if communicating to people about cardiovascular diseases (cvds) by using risk assessment tools (framingham regicor and heart age) would lead to improvement in their cvd risk factors. changes in physical activity (number of sessions of physical activity per week), smoking behavior, and other modifiable risk factors, involving anthropometrical and blood pressure data. climate change this study assessed the effect of people's beliefs about nature and science on their perspective about uncertainty in relation to climate change. participants' willingness to carry out positive environmental behaviors (e.g., reducing water use) and agree on a household carbon budget. self-efficacy improvement harris, sutherl & hutchinson ( ) medicine this study analyzed the influence of parents' marital status, and parent-child sexual communication and relationship on male adolescents' knowledge regarding hiv and stds, and their intentions and their implementation of preventive behaviors. six-item condom use self-efficacy scale (e.g., ''i am confident that i know how to use a condom.'') feenstra, ruiter & kok ( ) other (traffic safety) this study assessed the impacts of a school-based road safety program on risk perception, attitude, intention, and behaviors in relation to risky cycling among th- th-grade students. perceived self-efficacy for safe cycling (e.g., controlling the bicycle and applying traffic rules) in comparison with peers. in contrast, ''trust building'' is frequently included among the proposed purposes of risk communication, whereas it was rarely addressed in the studies assessed in this research ( %). further, while the organizations extended the target of risk communication in their statements to non-citizen parties, such as industries and media, those groups were rarely targeted in risk communication activities in the studies assessed in this research. consequently, relevant indicators were not discussed in the study articles. table shows the frequency data, which is cross-tabulated with study field and other variables. in most fields of study, risk communication activities were conducted in a non-/pre-crisis phase, whereas nearly half of the risk communications in the field of nuclear and radiological disasters/emergencies were conducted in a non-/pre-crisis phase, and the remaining were in a post-crisis phase. the table shows that the majority of risk communication targets citizens/npos. at the same time, % in the field of chemical substances targeted other groups. in the medical field, half of the risk communications were conducted at an individual level or in a small group, whereas risk communication in other fields was conducted mainly in a larger group or to an entire population of interest. table s shows the results of the analyses between study field and other variables. the series of analyses found significant associations between study field and communication type (p < . ). multiple comparisons suggested a significant difference pertaining to communication type between risk communications in the field of medicine from those in food safety (p < . ). table highlights the diversity in objectives and indicators of risk communication activities. for instance, the fields of food safety and other (i.e., non-nuclear/radiological) disasters and emergencies had a higher percentage in terms of risk communications aiming or addressing ''trust building'' ( % and %, respectively) than other fields, especially compared to the field of medicine ( %). the chemical substance field had a higher percentage ( %), and the field of nuclear and radiological disasters/emergencies had a lower percentage ( %) compared with other fields with regard to risk communications focusing on ''decision making and behavior change.'' table also suggests some percentage differences in intervention timing, target audience, and communication type by objective/evaluation indicator. the main objectives and indicators of risk communications conducted in a non-/pre-crisis period were ''knowledge increase,'' ''change in risk perception and concern alleviation,'' and ''decision making and behavior change'' ( %, %, and %, respectively). ''decision making and behavior change'' was a main indicator for risk communications conducted in a crisis period ( %). ''knowledge increase,'' and ''change in risk perception and concern alleviation'' were the main indicators for risk communications conducted in a post-crisis period ( %, %, respectively). there was over % difference in ''change in risk perception and concern alleviation'' between risk communications targeting citizens/npos compared to although the total number of studies included in the analysis was , the total number of each variable varies owing to the allowance of multiple responses. the percentages were based on the total number of each study field. ( ) ( ) ( ) ( ) food safety (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) chemical substances (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) nuclear and radiological disasters/emergencies (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) other disasters/emergencies (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) climate change (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) crisis (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) post-crisis (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) target audience citizens/npos (n = ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) other ( the total number of each variable varies because of the allowance of multiple responses. percentages were based on the total number of each value. while risk communication has been implemented in a variety of ways for diverse objectives, this study revealed some overall trends in the objectives, approaches and evaluation indicators applied for recent risk communication activities. at the same time, the results of analysis also suggest that there are some patterns in implementation; associations exist between the study field and the communication type, and between the objectives/evaluation indicators and the intervention timing and communication type. these facts may provide useful insights to those who are involved in risk communication in designing and evaluating their activities. this study also identified the limited attention in current practices to cultivating trust building and reduction in psychological distress, as well as targeting noncitizen/npo groups. addressing these gaps is an important way forward for a sustainable path toward effective risk management and better resilience. hiritsu no sa how do osteoporosis patients perceive their illness and treatment? implications for clinical practice interpersonal amplification of risk? citizen discussions and their impact on perceptions of evaluating traffic informers: testing the behavioral and social-cognitive effects of an adolescent bicycle safety education program food and agriculture organization of the united nation, world health organization. . the application of risk communication to food standards and safety matters. fao food and nutrition paper risk communication applied to food safety handbook. rome: food and agriculture organization of the united nations and world health organization an introduction to risk communication effective communication of risks to young adults: using message framing and visual aids to increase condom use and std screening effect of health belief model based intervention on promoting nutritional behaviors about osteoporosis prevention among students of female middle schools in isfahan risk communication for public health emergencies parental influences of sexual risk among urban african american adolescent males the effectiveness of a graphical presentation in addition to a frequency format in the context of familial breast cancer risk communication: a multicenter controlled trial international federation of red cross and red crescent societies, united nations children's fund, world health organization. . covid- global response: risk communication and community engagement (rcce) strategy. geneva: international federation of red cross and red crescent societies effectiveness of the heart age tool for improving modifiable cardiovascular risk factors in a southern european population: a randomized trial exploring the role of gain versus loss framing and point of reference in messages to reduce human-bear conflicts risk communication: a handbook for communicating environmental, safety, and health risks jichitai no tame no kagaku-busshitsu ni kansuru risukukomyunikẽshon manyuaru (manual for risk communication concerning chemical substances in municipalities) (partial revisions in the amplification of risk in experimental diffusion chains influence of evidence type and narrative type on hpv risk perception and intention to obtain the hpv vaccine effective risk communication: the nuclear regulatory commission's guidelines for external risk communication a macro analysis of productivity differences across fields: challenges in the measurement of scientific publishing the key role of experiential uncertainty when dealing with risks: its relationships with demand for regulation and institutional trust r: a language and environment for statistical computing. vienna: r foundation for statistical computing unquestioned answers or unanswered questions: beliefs about science guide responses to uncertainty in climate change risk communication annex i: ''state of the art'' report on risk communication bundesinstitut für gesundheitlichen verbraucherschutz und veterinärmedizin public participation in hazard management: the use of citizen panels in the psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the covid- pandemic historical origins of the health belief model the health belief model and preventive health behavior the effectiveness of nutritional education on the knowledge of diabetic patients using the health belief model conspiracy theories and fake news: fighting the covid- 'infodemic effective physician-patient communication and health outcomes: a review development and evaluation of a risk-communication campaign on salmonellosis psychological and educational intervention to improve tuberculosis treatment adherence in ethiopia based on health belief model: a cluster randomized control trial united states environmental protection agency united states environmental protection agency available at crisis and emergency risk communication (cerc) ( update). atlanta: united states department of health and human services united states department of health and human services united states department of health and human services this article was prepared after the authors added analyses, results, and discussion to a report for the research on the health effects of radiation organized by the ministry of the environment, japan (http://www.env.go.jp/chemi/chemi/rhm/r e_ .pdf). we thank our colleagues who are in charge of other parts of the larger research project that encompasses this study. they provided valuable input during the preparation and implementation of this study. the views discussed in this paper are those of the authors and do not necessarily reflect the positions of those colleagues, the affiliated institutions, or the funding agency. the following grant information was disclosed by the authors: the research project on health effects of radiation organized by the ministry of the environment, japan. the authors declare there are no competing interests. • akiko sato performed the experiments, analyzed the data, prepared figures and/or tables, authored or reviewed drafts of the paper, and approved the final draft.• kaori honda, kyoko ono, reiko kanda, takehiko i. hayashi, yoshihito takeda, yoshitake takebayashi and tomoyuki kobayashi performed the experiments, analyzed the data, authored or reviewed drafts of the paper, and approved the final draft.• michio murakami conceived and designed the experiments, performed the experiments, analyzed the data, prepared figures and/or tables, authored or reviewed drafts of the paper, and approved the final draft. the following information was supplied regarding data availability:the raw data are available as a supplemental file. supplemental information for this article can be found online at http://dx.doi.org/ . / peerj. #supplemental-information. key: cord- -stc pbj authors: cardona, carol; travis, dominic a.; berger, kavita; coat, gwenaële; kennedy, shaun; steer, clifford j.; murtaugh, michael p.; sriramarao, p. title: advancing one health policy and implementation through the concept of one medicine one science date: - - journal: glob adv health med doi: . /gahmj. . sha: doc_id: cord_uid: stc pbj numerous interspecies disease transmission events, ebola virus being a recent and cogent example, highlight the complex interactions between human, animal, and environmental health and the importance of addressing medicine and health in a comprehensive scientific manner. the diversity of information gained from the natural, social, behavioral, and systems sciences is critical to developing and sustainably promoting integrated health approaches that can be implemented at the local, national, and international levels to meet grand challenges. the concept of one medicine one science (comos) as outlined herein describes the interplay between scientific knowledge that underpins health and medicine and efforts toward stabilizing local systems using linked case studies: the food system and emerging infectious disease. forums such as the international conference of one medicine one science (icomos), where science and policy can be debated together, missing pieces identified, and science-based collaborations formed among industry, governmental, and nongovernmental policy makers and funders, is an essential step in addressing global health. the expertise of multiple disciplines and research foci to support policy development is critical to the implementation of one health and the successful achievement of global health security goals. numerous interspecies disease transmission events, ebola virus being a recent and cogent example, highlight the complex interactions between human, animal, and environmental health and the importance of addressing medicine and health in a comprehensive scientific manner. the diversity of information gained from the natural, social, behavioral, and systems sciences is critical to developing and sustainably promoting integrated health approaches that can be implemented at the local, national, and international levels to meet grand challenges. the concept of one medicine one science (comos) as outlined herein describes the interplay between scientific knowledge that underpins health and medicine and efforts toward stabilizing local systems using linked case studies: the food system and emerging infectious disease. forums such as the international conference of one medicine one science (ico-mos), where science and policy can be debated together, missing pieces identified, and science-based collaborations formed among industry, governmental, and nongovernmental policy makers and funders, is an essential step in addressing global health. the expertise of multiple disciplines and research foci to support policy development is critical to the implementation of one health and the successful achievement of global health security goals. los numerosos acontecimientos de transmisión de enfermedades entre especies, de los cuales el virus del Ébola es un ejemplo claro y reciente, ponen de manifiesto las complejas interacciones que existen entre la salud humana, animal y medioambiental, así como la importancia de abordar la medicina y la salud de una manera científica e integral. la diversidad de la información obtenida de las ciencias naturales, sociales, conductuales y de los sistemas es fundamental para el desarrollo y fomento sostenibles de enfoques integrados de salud que puedan implementarse a nivel local, nacional e internacional para atender los grandes retos. el concepto de una medicina una ciencia (concept of one medicine one science, comos) esbozado aquí describe la interrelación entre el conocimiento científico que sustenta la salud y la medicina, y los esfuerzos hacia la estabilización de los sistemas locales por medio de dos estudios de casos relacionados: el sistema alimentario y las enfermedades infecciosas emergentes. los foros como la conferencia internacional de una medicina una ciencia (international conference of one medicine one science, icomos), donde se hace posible el debate conjunto de la ciencia y la política, la identificación de eslabones perdidos, y la formación de colaboraciones basadas en la ciencia entre los formuladores y fundadores de políticas industriales, gubernamentales y no gubernamentales, representan un paso decisivo para abordar el tema de la salud mundial. la experiencia de múltiples disciplinas y enfoques de investigación para apoyar el desarrollo de políticas es fundamental para la implementación de una salud y el logro de los objetivos relativos a la seguridad de la salud mundial. human, animal, and environmental health are inextricably linked in our modern, highly globalized society. we expect better health, secure food, clean water, and more comfort from limited natural resources. balancing competing demands of human health, animal health, and sustainable environmental health is a grand challenge of our time. as the distance between human, domestic animal, and wildlife populations narrows and global trade and travel amplify our connectivity, pathogens shared by humans and animals have concurrently emerged. since , among many examples, humans experienced outbreaks of west nile virus in the united states and europe, severe acute respiratory syndrome (sars) virus in china, middle east respiratory syndrome coronavirus (mers-cov) in the middle east, and the emergence of the ebola virus in west africa. shared pathogen exchange is perhaps best illustrated in the case of influenza, where humans serve as the source of influenza a virus (iav) infection of pigs, and, after further evolution of the virus, it returns from pigs to humans, causing new outbreaks. the influenza outbreak was the most recent example of this cycle of human and animal infection. the failure to address interspecies transmission and ensuing pandemics as a one health issue has created the opportunity for continued emergence of novel iav like h n v that emerged as a human pathogen during the agricultural fair season. these events highlight the complex interactions between human, animal, and environmental health and the importance of addressing medicine and health in a scientific manner that considers all contributing factors. advancement of health at this level of complexity requires integration of medical disciplines spanning individual care to public health, with basic and applied sciences from atomic structure to sociology providing the knowledge base as shown in the figure. the concept of one medicine one science (comos) builds on the idea that the basic biological processes underlying health and disease share common features such that medical knowledge and expertise in one species is relevant and applicable to other species. the scientific approach that expands our understanding of biological processes and the rational basis for medical practice is the same for all species. thus, comos provides common ground to assist the organization of interdisciplinary groups to seek solutions to health challenges at local and global scales. another aspect of comos is development of forums that, in addition to medical and scientific participants, includes industry, governmental and nongovernmental policy makers, and funders to assist in communicating the interconnectedness of human, animal and environmental health to a broad audience so that development of public policies that guide health priorities and investments at the national and international level are informed by the best scientific knowledge. the concept of one health emphasizes the interconnectedness of animal, environmental and human health, and has become a part of the health security and international development lexicon. the revised international health regulations and global health security agenda (ghsa) are of many instruments that cement this connection/relationship/interdependence. at the international launch of the ghsa, the united states and other countries, the world health organization (who), food and agriculture organization (fao), and world organisation for animal health (oie) agreed to work to prevent, detect, and respond to global infectious disease threats from the perspective of one health. years before the release of the ghsa, the us agency for international development established the emerging pandemic threats program to "prevent, detect, and control" animal and human pathogens. these activities, which promote one health approaches in the united states and globally, are an important beginning but fall short of providing the robust scientific and culturally informed approach that is needed to address real world challenges. much dialogue on one health has focused on emerging disease surveillance, public health preparedness, and policy issues without connecting these issues to the scientific foundations that underlie pathogen emergence, global health threats, food security, environmental health, social organization, communication, and implementation of health, security, and safety measures. this limitation has resulted in a perceived and apparent separation of science and policy, sometimes diluting the utility of the one health movement. this article builds on the discussions and dialogue about the science of one health and its connection to policy that were held at the international conference on one medicine one science (icomos; www.icomos.umn.edu) in and to be held again in . in particular, it was concluded that the key roles of food and medicine in addressing health needs of a changing world require the support of rigorous science that empowers informed decision-making and development of useful policies. the goal of icomos is to examine the connections between science and one health policy implementation by ( ) focusing on case studies and research that demonstrate the successful integration of human, animal, plant, and environmental health and social and behavioral sciences; ( ) examining the science-policy connection by convening panels that include scientists, policy makers, and representatives from private industry; and ( ) conducting forward-looking workshops in areas of research, collaboration, and policy formulation. icomos- was focused on of the most important grand challenges of our time-food safety/security and emerging infectious diseases. , good policy must be based on objective scientific studies that integrate epidemiology, ecology, microbi- original article ology, social science, and economics to balance the expectation of safe and nutritious food with the need for efficient and profitable production, and sustained environmental health. given that an estimated million people are currently suffering from malnutrition and that the combination of human population growth and consumer preference shifts associated with a rising global middle class are expected to exacerbate this problem, global production and delivery of food for protein, energy, and micronutrients must not just be maintained, it must be increased. in addition, existing land and water resources are already strained and their availability for agriculture will likely decrease, especially as the impacts of climate change shift traditional production regions. the obvious solution is to produce more efficiently, yet the very strategies that promote efficient production of food, such as concentrated farming systems, monoculture cropping, and chemical inputs of fertilizer, pesticides, and herbicides, have unintended consequences that threaten human, ani-mal, and environmental health. we are faced with a paradox in which the demand for increased food production to improve human health today sows the seeds of resource depletion that limit health advances tomorrow. thus, new research on the direct and indirect impacts of food production on human, animal, and environmental health as well as social, organizational, and behavioral sustainability should be a priority. ensuring that sufficient food is not only safely and efficiently delivered to consumers but that it is produced in ways according to local preferences presents another paradox. consumer demand for local and organic production systems actually increases the greenhouse gas footprint of most developed and many developing country food systems, depending on the crop or animal product [ ] [ ] [ ] and also can increase food safety risks relative to today's widely used production systems. those producers that remain local are often small in size, thus limiting benefits of scale, and many use organic methods, which can limit their ability to prevent disease through approaches such as constructing barriers and facilities for containment. the result is increased contact with wildlife, which increases opportunities for the transmission of infectious diseases to crops, livestock, and humans. for instance, interaction between domestic poultry and wild waterfowl reservoirs has resulted in the introduction of new iav, and the movement of h hpai from domestic poultry to free-flying bird populations demonstrates that the exchange can be bidirectional, which changes paradigms of transboundary disease spread. the interface between wildlife and agriculture will only increase as more land is converted for agricultural use to meet consumer demands, thus forcing wildlife into shrinking habitats or to adapt to increased contact with humans and livestock. housing food animals inside helps to protect animal health, prevent cross-species disease transmission, and improve production efficiency, but it does not always meet consumer preference for local needs and resources. nontherapeutic (nonclinical) antibiotic use in food animals is a tool that promotes production efficiency, but it has been associated with a rise in antibiotic resistance of human pathogens. however, epidemiological and ecological studies fail to support a causal link; instead, these studies indicate the spread of antibiotic resistance from humans to pigs and chickens. in the future, the world food summit global food strategy of "providing access for all people at all times to sufficient, safe, and nutritious food to maintain a healthy and active life" must be expanded to include considerations for environmental sustainability, animal welfare and non-nutritional aspects of public health. progress toward these goals requires strong linkage of scientific knowledge and discovery that helps both to advance medical practice and health improvement as well as inform health policy development. human population expansion and exploration has increased as never before, and thus attention to the risk of disease emergence at the interface between humans, domesticated animals, and wildlife is increasingly important. while many human pathogens have wildlife reservoirs, the converse is also an issue. humans and their companion animals have triggered epidemic plagues of canine distemper in serengeti lions and morbillivirus in pacific seals while spreading influenza a to food animal species. other dramatic changes include the explosive growth in global travel and trade patterns and legal and illegal trade in live animals, animal products, and wildlife as well as effects of climate change on all of the above. retrospective and emerging analyses may provide insights into these systems. however, focusing on the processes and mechanisms that facilitate pathogen evolution and emergence will help us prepare for unpredictable new outbreaks, thus raising awareness of prevention and control policies that could reduce both the likelihood and magnitude of disease emergence and its resulting effects on animals and humans. single approaches to comprehend and anticipate disease emergence, especially using simplified disease models, are unlikely to produce informative insights involving environmental factors, multiple reservoirs, and complex human-animal-environment interactions. concepts of wildlife reservoirs and spill-over/ cross-species transmission into food animal and human populations followed by expansion and outbreak potential have been developed into mathematical models. although not a predictor in itself, models of zoonotic transmission dynamics have made valuable contributions to inform public health recommendations for control of novel h n influenza and sars and are crucial for understanding pathogen transmission patterns and changes in disease epidemiology. human orthopoxvirus infection is a highly relevant example in which modeling based on rigorously collected data provides prevention strategies for a highly plausible emergent disease. the global human population is increasingly susceptible to smallpox due to the cessation of vaccination programs following eradication. loss of crossreactive immunity has opened an ecological niche that can and has been replaced by related orthopoxviruses, including monkeypox in the congo and novel orthopoxvirus in the country of georgia. emergence of new orthopoxvirus outbreaks with pandemic potential is possible as human-infectious poxviruses circulate in natural reservoirs. the recent discovery of viable smallpox in a us food and drug administration refrigerator on the national institutes of health (nih) campus recently reinvigorated the discussion of both susceptibility and/or risks from infections to smallpox. the specter of a new pandemic, fueled by relatively recent experience with the emergence of aids and new influenza viruses, has driven the us centers for disease control and prevention, the nih-national institute of allergy and infectious diseases, the us department of agriculture, the us agency for international development, and others to develop programs focused on predictive modeling of and early detection and response to novel pathogens that have evolved under a complex set of pressures such as environmental pollution, land use changes, new trade patterns, climatic change, and other anthropogenic factors. the role of medicine in addressing individual and public health needs to be supported by rigorous science that empowers informed decision-making and development of useful policies in the face of unexpected disease threats. the rapid growth and persistence of the ongoing outbreak of ebola virus in west africa presents an unfortunate but perfect opportunity for implementing science-based policy at the crossroads of emerging infectious disease ecology and sustainable food security. experts hypothesize that ebola virus entered the west african population through consumption of original article infected fruit bats, a plausible scenario given local food needs and practices. , the ongoing outbreak has stressed social organization and an already thin public health infrastructure to the breaking point in the affected countries. it threatens to exacerbate baseline food insecurity as disease control measures and fear shut down food and agriculture systems, further stressing local food security. this situation makes for the "perfect storm" of grand challenges in the one health arena. frighteningly, while more than cases and deaths have been recorded as of july , , a new ecological niche risk model predicts that million people in central and west african countries are at potential risk for ebola. , while the world seems to be stepping up with much-needed scientific, medical, and infrastructure support to this tragedy, broader policies and preparedness are needed for prevention, containment, and response if we are to avoid more extreme human suffering from the virus itself as well as malnutrition, community instability, and other social consequences. addressing the grand challenges of our timesuch as novel disease emergence and food security-is difficult from any perspective. but the universal scientific discovery and exploration approaches that have been applied so effectively to resolve focused problems offer promise in addressing the complex health issues of modern life. a linear refocusing of health research away from disease surveillance and investigation resulting primarily in treatment toward environmental surveillance resulting in prediction and prevention is not enough to inform societal debates on these complex health issues. reducing challenges to simple scenarios allows us to find solutions that do not address the complex problems we face but instead bring on a myriad of unintended and undesirable consequences. grand challenges do not have simple solutions. rather, they represent "wicked problems" that are complex and difficult-to-balance dilemmas with fluid dynamics whose competing components change over time. the creation of forums for convergence on grand challenges where science and policy can be debated together, missing pieces identified, and science-based collaborations stimulated in the presence of industry, governmental and nongovernmental policy makers, and funders is an essential step. the underpinnings of comos-ie, promoting team science that builds on the expertise of different disciplines, stakeholders, and research foci to support policy development-is all the more relevant to the implementation of one health and the successful achievement of global health security goals (figure) . universal scientific discovery and exploration approaches that have been applied so effectively to advance human society will need to be applied to complex health issues of modern life so that the resulting knowledge can inform public policy and decision-making at every level. global trends in emerging infectious diseases swine-to-human transmission of influenza a(h n ) virus at agricultural fairs one health: scientific and technical review one medicine one science: a framework for exploring challenges at the intersection of animals, humans and the environment one medicine one science and policy households across all income quintiles, especially the poorest, increased animal source food expenditures substantially during recent peruvian economic growth solutions for a cultivated planet the effect of feed demand on greenhouse gas emissions and farm profitability for organic and conventional dairy farms the environmental impact of recombinant bovine somatotropin (rbst) use in dairy production the impact of organic farming on food security in a regional and global perspective food safety and organic meats epizootiology of avian influenza-simultaneous monitoring of sentinel ducks and turkeys in minnesota avian flu: h n virus outbreak in migratory waterfowl sources of antimicrobial resistance world health organization viruses of the serengeti: patterns of infection and mortality in african lions mass die-off of caspian seals caused by canine distemper virus global transmission of influenza viruses from humans to swine nine challenges in modelling the emergence of novel pathogens epidemic dynamics at the human-animal interface vacated niches, competitive release and the community ecology of pathogen eradication safety lapses in us government labs spark debate fruit bats as reservoirs of ebola virus ebola virus disease: from epidemiology to prophylaxis impact of the west african ebola virus outbreak on food security who ebola data and statistics. situation summary mapping the zoonotic niche of ebola virus disease in africa. elife dilemmas in a general theory of planning key: cord- -un ztqf authors: bakken, suzanne title: informatics is a critical strategy in combating the covid- pandemic date: - - journal: j am med inform assoc doi: . /jamia/ocaa sha: doc_id: cord_uid: un ztqf nan this issue of journal of the american medical informatics association issue includes articles - and a correspondence that address the coronavirus disease (covid- ) pandemic. we published the articles through advanced access immediately after acceptance to disseminate innovative informatics strategies and thoughtprovoking perspectives to inform clinical practice as well as policy decision making. this open access content is also available at jamia.org and on our publisher's covid- hub (https://academic. oup.com/journals/pages/coronavirus). the role of biomedical and health informatics has been critical in the system response to the covid- pandemic. thus, it is fitting that this issue starts off with an american medical informatics association position paper that describes a health informatics practice analysis that complements the previously published american medical informatics association clinical informatics subspecialty practice analysis. as compared with the latter, which focused on physicians, the focus of gadd et al is on health informatics professionals comprising practitioners with clinical (eg, dentistry, nursing, pharmacy), public health, health informatics, or computer science training. the authors applied methods to meet the practice analysis objective of developing a comprehensive and current description of what health informatics professionals do and what they need to know. first, independent subject matter expert panels contributed to the development of a draft health informatics delineation of practice. second, an online survey was distributed to health informatics professionals to validate the draft delineation of practice by rating the draft items related to domain, tasks, knowledge, and skills; qualitative feedback was also provided on the completeness of the delineation of practice. informed by a sample of > survey participants, this resulted in domains, tasks, and knowledge and skill statements. study findings will inform health informatics certification, accreditation, and education activities. the covid- articles highlighted in this editorial reflect the domains identified in the health informatics practice analysis: foundational knowledge; enhancing health decision making, processes, and outcomes; health information systems; data governance, management, and analytics; and leadership, professionalism, strategy, and transformation, as well as similar domains in the physician clinical informatics subspecialty practice analysis. the clinical articles illustrate the important relationships among technical knowledge and skills domains and those focused on decision making, processes, and outcomes, and leadership. moreover, articles highlight the important linkage between rapidly evolving federal policy and informatics practice during the pandemic. , reeves et al, from university of california, san diego, describe the rapid implementation of technological support for optimizing clinical management of the covid- pandemic from the perspective of an academic medical center. critical to these efforts was the establishment of an incident command center on february , , for -hour monitoring and adaptation to rapidly evolving conditions and recommendations on a local, state, federal, and global scale. a second significant component informing the response was an assessment of the current state with regard to this context, which revealed institutional needs requiring technology support. this included the design and implementation of electronic health record (ehr)-based rapid screening processes, as well as expansion of system-level ehr documentation templates (eg, urgent care/emergency department screening or testing), clinical decision support (eg, isolation, who should be tested), reporting tools (eg, operational dashboard and tracking system for persons under investigation), and patient-facing technology (eg, video visits for outpatient encounters) related to covid- . the inclusion of information services representation in the incident command center enabled real-time identification of failures and successes and a focus on evolving needs, which was foundational to building cohesive systems as an institutional response to the covid- pandemic. judson et al, from university of california, san francisco, rapidly deployed a patient-facing self-triage and self-scheduling tool on their patient portal using a toolkit provided by their ehr vendor. they made the tool available to primary care patients with active portal accounts (about two-thirds of their patients). through the ucsf coronavirus symptom checker module, basic demographic information is populated from the ehr, and asymptomatic patients are asked about exposure history and then provided relevant information. in contrast, symptomatic patients are triaged into of categories (emergent, urgent, nonurgent, or self-care) and subsequently connected to care via telephone hotline or self-scheduling. all responses and interactions are stored in the ehr. during the first days of use, the tool was accessed times by unique patients. the triage dispositions of the % of symptomatic patients were emergent ( %), urgent ( %), nonurgent ( %), and selfcare ( %). the primary benefit of the tool beyond its efficiency for patients is prevention of unnecessary in-person encounters, which diminishes patient exposure, decreases personal protective equipment (ppe) use, and enables clinicians to focus on more acutely ill patients. in a perspective, turer et al, from vanderbilt university medical center, describe an approach they call electronic ppe (eppe) within the context of emergent policy changes related to telemedicine and the emergency medical treatment and labor act during the covid- pandemic. as distinct from telemedicine, they define eppe as the use of telemedicine tools by on-site medical providers to perform electronic medical screening exams while limiting physical proximity. the authors discuss the safety, legal, and technical factors necessary for implementing such a pathway. in terms of safety, they recommend performing medical screening exams using eppe only on "low-risk patients (ie, [less urgent] to [nonurgent]) with reassuring vital signs, few comorbidities, and chief complaints suggesting lower respiratory infection (fever, cough, shortness of breath)." legally, eppe is supported by a march , , centers for medicare and medicaid services update to emergency medical treatment and labor act enforcement that allows for on-site and off-site medical screening exams by qualified medical personnel using telemedicine equipment. from a technical perspective, they recommend using consumer devices such as facetime, skype, and zoom instead of dedicated telemedicine platforms because of their familiarity to providers. the approach of eppe has the potential to facilitate more frequent patient-provider interactions in other settings while reducing exposure and conserving ppe. in a perspective focused on balancing health privacy, health information exchange (hie), and research in the context of the covid- pandemic, lenert and mcswain argue that "our current regulations on the flows of information for clinical care and research are antiquated and often conflict at the state and federal levels" and call for proposed changes to privacy regulations. they recommend consideration of possible actions to enable the rapid communication of required health data necessary for a pandemic response by waiving the current legal barriers to hie while ensuring the privacy of individual health information: . the enactment of the health insurance portability and accountability act's complete federal preemption of all other data sharing and consent laws. the authors conclude that use of emergency federal powers to create a unified framework for data exchange is an essential step toward effective response to the clinical, public health, and research challenges of the covid- epidemic. in my first editorial as editor-in-chief, i called for a consequentialist informatics approach in which we focus our informatics research and its translation in practice on important health issues. the articles in this issue that focus on covid- exemplify this approach and highlight the centrality of informatics in combating this devastating pandemic by doing what matters most. rapid response to covid- : health informatics support for outbreak management in an academic health system rapid design and implementation of an integrated patient self-triage and self-scheduling tool for covid- electronic personal protective equipment: a strategy to protect emergency department providers in the age of covid- balancing health privacy, health information exchange, and research in the context of the covid- pandemic construction of g all-wireless network and information system for cabin hospitals telehealth transformation: covid- and the rise of virtual care use of self-administered surveys through qr code and same center telemedicine in a walk-in clinic in the era of covid- domains, tasks, and knowledge for health informatics practice: results of a practice analysis domains, tasks, and knowledge for clinical informatics subspecialty practice: results of a practice analysis doing what matters most none declared. key: cord- -ebh adi authors: flett, gordon l.; heisel, marnin j. title: aging and feeling valued versus expendable during the covid- pandemic and beyond: a review and commentary of why mattering is fundamental to the health and well-being of older adults date: - - journal: int j ment health addict doi: . /s - - - sha: doc_id: cord_uid: ebh adi the current commentary and review examines the potentially protective role of feelings of mattering among elderly people during typical times and the current atypical times associated with the covid- global pandemic. mattering is the feeling of being important to others in ways that give people the sense that they are valued and other people care about them. we contrast this feeling with messages of not mattering and being expendable and disposable due to ageism, gaps in the provision of care, and apparently economically focused positions taken during the pandemic that disrespect the value, worth, and merits of older persons. we provide a comprehensive review of past research on individual differences in mattering among older adults and illustrate the unique role of mattering in potentially protecting older adults from mental health problems. mattering is also discussed in terms of its links with loneliness and physical health. this article concludes with a discussion of initiatives and interventions that can be modified and enhanced to instill a sense of mattering among older adults. key directions for future research are also highlighted along with ways to expand the mattering concept to more fully understand and appreciate the relevance of mattering among older adults. this article is about the need to matter among older people. the quote above from nancy schlossberg from her seminal work on mattering versus marginalization reflects the fact that even though people can and do differ enormously, they share a need to feel valued and significant to other people who care about them. they also share a basic need to feel connected to other people and feel a sense of fit rather than feeling like a misfit. these common needs to matter to others and to belong fit well the general belief that people of all backgrounds are more similar than they are different, and that we should focus to a greater degree on commonalities and what brings us together than on apparent differences which can serve to divide us. the need to matter applies to people of all ages and of vastly different backgrounds and cultures. it is a feeling that is relevant from the cradle to the grave and it is a global and universal need. there is still room for individual differences, however; some people will always have a stronger need to matter than will others, just as some may be more sensitive to perceived social connections and support. moreover, at present, billions of people feel like they actually do matter, while billions of other people feel like they do not matter or they do not matter as much as they should. this sense of not mattering enough is especially common among people who feel marginalized and left behind for social, political, economic, or other reasons, rather than feeling cherished and valued as human beings. the current article is both a review and a commentary focused on mattering in older people. it is based on a thorough and systematic search using multiple search engines, including google scholar, to identify any relevant research conducted on mattering among older people. most of the review focuses on articles in refereed journals, but detailed empirical results found in two key chapters are also provided (see fazio ; pearlin and leblanc ) . our overarching goal was to be as contemporary and as up-to-date with both our review and our commentary as possible. in this regard, we also refer to national and international events pertaining to the treatment and care of older people that have quite recently occurred during the pandemic. so why our current focus on the need to matter among older adults? and why focus on this need now at this point in time? there are three interrelated reasons. first, in their work that introduced the mattering concept, rosenberg and mccullough ( ) observed astutely that mattering is particular relevant for two groups of people-young people and elderly people. specifically, they suggested that, "mattering may be relatively high among children and adults, among adolescents and old people. the young child feels that he matters because the world revolves around him, because he is the center of the universe. the adult matters because he runs the world" (p. ). regarding the relevance of mattering to older people, rosenberg and mccullough ( ) went on to note that mattering is tied closely with the transition to retirement. here they addressed the core fear that haunts many retirees by noting that, "it has been suggested that one problem of retirement is that one no longer matters; others no longer depend upon us" (p. ). second, the need for older people to feel like they matter and to wonder how much they actually do matter is a very salient theme right now as the covid- global pandemic continues. the messages from many political leaders are centered appropriately on urging people to engage in physical distancing, while awaiting development of vaccines and antibodies because this practice will help stop the spread of the virus and this is especially required to protect older and immunocompromised people who are more susceptible to the ravages of the coronavirus. this message is often wrapped around the theme that older people are cherished and we need to do whatever it takes to protect their health and well-being during this high-risk period. this focus includes the recognition that self-isolation practices implemented to counter covid- , albeit well-intentioned, disproportionately impact older adults and urgent action is needed to limit the mental health and physical health impacts among isolated older people (see armitage and nellums ) . finally, it is generally accepted that there are many challenges that have been brought about by the covid- global health crisis and the requirement that people engage in physical isolation. anxiety is heightened due to concerns about personal safety and the uncertainty of how and when the pandemic will be resolved. moreover, as noted above, physical distancing has led to the experience of social isolation among some people, especially those who are living alone and those who may lack web-enabled smartphones or other electronic devices that could help them remain in contact with friends and loved ones. loneliness is already a profound public health concern, especially among older people, and physical isolation is adding exponentially to the social isolation that is typified by loneliness. it was a grave concern in the usa before the pandemic; this was illustrated by the us senate special committee on aging chaired in by susan collins, united states senator from maine. this committee held hearings on the topic "aging without community: the consequences of isolation and loneliness." the disruption to daily routines and restriction of usually pleasurable activities as a result of the pandemic, including visiting with friends, children, and grandchildren, is also having a strong impact on people. given these changes, flett and zangeneh ( ) outlined how and why mattering is an essential resource for coping with and adapting to the pandemic. it was argued that everyone needs a sense of significance and being important to others in the best of times, but this is especially the case in challenging times and in anxiety-provoking crisis situations that entail being separated from others. this argument is particularly germane to the life experiences of older people coping with this global health crisis. older members of society have many reasons to be fearful and many have already been grappling with loneliness and mental health problems. unfortunately, expressions of concern about the health and welfare of older people and apparent steps taken to ensure their well-being are at variance with current realities. global statistics are mounting in ways that confirm that concerns about older people and their mortality are not overstated. there is growing evidence from various parts of the world of the disproportionate death and dying among older people (see onder et al. ; promislow ) . over % of deaths related to covid- were of individuals years or older, and more than % were over -an age group with a mortality rate times that of the global average. residential care homes, including long-term care (ltc) and assisted living (al) homes, have been hit especially hard and account for more than half of pandemic-related deaths worldwide (see comas-herrera et al. ) , posing a realistic source of existential anxiety and distress for older residents and their families. close-quarters living and limited access to personal protective equipment increase the risk of transmission, which, together with healthcare challenges associated with staffing shortages, results in multiple fatalities. the numbers of deaths are troubling but even more disconcerting are seemingly endless stories of neglect and mismanagement that have appear to be costing people their lives. key needs, both tangible and emotional, have been neglected and this is relevant to our premise because neglect is regarded as a primary precipitant of feelings of not mattering (see flett et al. a) . some of the more heinous incidents and situations involving apparent neglect of older adults in the context of the covid- pandemic are listed in table . this table contains a chronology of select occurrences. comparable events have already resulted in a litany of class action lawsuits by family members and urgent calls for public health inquiries to not only increase accountability but lead to necessary systemic change and better practices and procedures going forward. in addition to the incidents and situations in table , an exposé in the montreal gazette revealed one nursing home that apparently concealed the deaths of residents and many of these people died after most staff members abandoned the facility (see feith ) . some seniors did not have dignified deaths; indeed, the report indicated that they had gone for days without water, food, or a diaper change (derfel ) . more generally, actual occurrences include refusals of hospitals to provide treatment, improper treatment of deceased elders, and sending patients confirmed to have the virus to nursing homes, thereby increasing the risk for elderly residents. physical distancing requirements are having additional impacts on the ability of long-term care homes and assisted living residences to care for their older residents; prohibitions against large group meetings mean that residents cannot eat in cafeterias and common rooms, further limiting social connection, and overwhelming staff members who now must deliver food individually, limiting the amount of time and attention that they can pay to residents. these subtler impacts of the pandemic on the health and well-being of older adults are likely not being evaluated. a more recent exposé by the globe and mail of the situation in ontario, canada, also paints an exceptionally unfavorable picture. this article about this investigation is titled "systematic failings fuelled care-home outbreak" (see howlett ) . it is based on an extensive series of interviews and a review of documents filed with the ontario supreme court, as well as ontario ministry of labour inspection reports, and internal corporate records. key shortcomings included having home inspections conducted by telephone and the chief table chronology of select pandemic-related incidents and situations in connoting that older people do not matter or do not matter enough march , -spanish military finds corpses and seniors abandoned in care homes (benavides ) april , -italy's lombardy region wracked by exceptionally high number of deaths, totally about half of deaths in italy. deaths including thousands of elderly people described by one who official as a "massacre"; regional government makes decision on march th to place patients with covid- virus in nursing homes and staff in some homes instructed to not wear protective masks because masks will scare the residents (winfield ) may , -horrific deaths in an australian nursing home reported after an infected nurse works six shifts despite having mild virus symptoms. family members of residents express upset about inconsistent communication (zishuo ) may , -sweden's herd immunity strategy and failure to enact lockdown leads to mass deaths in swedish elder care homes; "terrible numbers" dramatically underestimated due to decision to only count deaths of persons who had covid- test (shilton ) may , -decision of new york to send recovering covid- virus patients to nursing homes characterized as "a fatal error" (mathews ) may , -elderly patients characterized as "sacrificial lambs" detected with coronavirus are released back to care homes in april; elderly people at st. nicholas care home in liverpool, england, die after hospital discharge (kelly and coen ) may , -hospitals in lima, peru, stop admitting elderly patients with coronavirus in part due to lower recuperation rates relative to younger patients (torres ) may , -nurses in care homes in sweden allege that people ill with the virus and or older are refused access to hospital and life-saving equipment despite potentially having many years to live (savage ) may , -report surfaces that older people in hamilton, ontario nursing home were transferred to st. joseph's healthcare but one male patient was forgotten and left entirely by himself in the evacuated nursing home (frketich ) medical officer of health waiting until april st to issue the decree that everyone in longterm care homes is to be tested for covid- . the deplorable conditions at sites in ontario were confirmed by a canadian military report that detailed conditions of severe neglect deemed to reflect "borderline abuse" or actual abuse in ontario care homes along with "blatant disregard" for basic infection control measures (see stephenson and bell ) . deplorable situations came to light in five residences once military personnel were deployed to assist in long-term care homes. ontario premier doug ford described these accounts as horrific and prime minister justin trudeau expressed his strong feelings, concluding that, "it is the elderly who are suffering the most in this pandemic." the stories that have emerged thus far underscore the lack of resources and planning that have left too many older people and staff members in vulnerable and potentially lifethreatening situations. for instance, in canada, the deaths continue to escalate across most provinces and this dovetails with years of concerned frontline people and academic scholars calling for improvements and more resources for the care system. these calls have been renewed and extended (see béland and marier ) . collectively, it has been estimated that four out of five covid- -related deaths in canada have been linked with senior homes (see brean ) . given these emerging realities in canada and elsewhere, it would be reasonable for older people in many countries to feel that professed concerns about their well-being either represent "lip service" or implemented safeguards simply add up to "too little" and "too late" given strong evidence of widespread system failure. the circumstances listed in table demonstrate some horrific situations in nursing homes and long-term care facilities in various parts of the world. second, some very troubling views about older people in general have been expressed during the pandemic. some views have come from political leaders, while others have come from members of the media and social media influencers. these views have led some authors to consider whether the pandemic will worsen the narrative about aging in terms of the proliferation of stereotypes. these are often signified by referring to the pandemic with harsh social media hashtags such as "#boomerremover" and "#grandmakiller" (see eisenberg ) . ironically, as many younger people are commenting that their grandparents' generation saved the world by fighting fascism and oppression, they are saving it by sitting around at home, and there is a lack of recognition that those same grandparents are now being sacrificed in panicked efforts to forestall an anticipated financial collapse. what is also being missed is the opportunity to learn and benefit from the survival resources and resiliency factors cultivated by older adults who have lived through times of war, oppression, discrimination, and financial collapse. as the statistics accumulate, it is natural for older people who are aware of these developments to become increasingly alarmed and demoralized not only about their health status prospects but also by the overarching question of whether they matter at all to other people. indeed, some older people have wondered openly about exactly when they became disposable (see socken ) . maria branyas, a -year old survivor of the spanish flu epidemic, stated that "the elderly are the forgotten ones of society" (the guardian ). this serves as a poignant counter-point to the quote attributed to gandhi that "the true measure of any society can be found in how it treats its most vulnerable members." older adults who have already felt marginalized and who have been subject to prejudice due to racism or classism may be particularly susceptible at present to feelings of not mattering to other people. unfortunately, some politicians have gone so far as to suggest that economic considerations must become the priority, even if it means the loss of lives. the argument here is that balance is needed and perhaps physical isolation and the shutdowns have gone too far or are now doing more harm than good from an economic perspective focused on costs versus benefits. it has been openly and crassly suggested by too many politicians that people who survive the pandemic will just have to live with the loss of other people, especially elderly people, because it is time to end social distancing in order to restart the economic engine as it is too dire to let it idle any longer. public calls to restart the economy, even if so doing confers health risks in vulnerable groups, can increase perceptions of lack of social worth among older adults, and this is especially among older adults who are sensitized to cues suggesting that they do not matter. another factor that has been identified as a factor during the pandemic that promotes the image of older people as being less important and contributes to ageism is that under certain circumstances, chronological age is listed as a deciding factor for determining which of two people in equal need are given a ventilator (for a discussion, see fraser et al. ) . they are also several instances of people being denied access to hospital treatment because of their age (see table ). it has been observed that older people are made to feel less significant as individuals by policies that characterize all older people as the same and fail to reflect the heterogeneity and varying levels of functioning and vitality among them. this too is regarded as a contributor to ageism (see fraser et al. ) . bob seger reminded us in one of his classic songs that it is easy for some people to "feel like a number." it is not difficult to take it personally when someone contends that it is just too bad, but some people may need to be sacrificed and needed medical equipment and supplies should be deployed to protect younger people. but how does it feel? one woman responded on twitter in early may by expressing her emotions in a clear and undeniable way in response to a televised segment she had watched. anne reminded us how it feels by saying, "that man you just had on said my life doesn't matter, that i am expendable, that i don't matter. i am a mother, wife, grandmother, community activist, community volunteer, i knit, i matter! i matter! i can't be sacrificed so he can go to walmart!" when it comes to lived experiences during the pandemic, this feeling of being expendable is, of course, not limited to older adults, but extends to others who are socially disadvantaged. findings are accumulating of the heightened risk of covid-related morbidity and mortality among hispanic and african americans. there have additionally been numerous reports from people of varying ages who are either refusing to go to work or who have quit their jobs given worry about their personal safety; however, it should be evident to any observer that the feeling of not being valued by the employer is also very salient and very strong among these workers. acts of defiance and disengagement should not be surprising; there is growing research evidence of how being made to feel unimportant and insignificant in the work setting is tied to turnover, work disengagement, and various negative emotions (jung ; jung and heppner ; richards et al. ) . the importance of mattering versus not mattering extends to healthcare workers. although some retired healthcare workers experience a sense of mattering when called back into service, one recent study found that nurses with lower levels of work mattering reported more burnout and less engagement (haizlip et al. ) . in contrast, workers thrive and flourish when they are valued and they know they matter. even small gestures and individualized inquiries about the personal life of the employee can have a huge positive impact. these are important themes for further consideration, but the current review article focuses on the need to matter among older adults. our analysis examines relational mattering (i.e., mattering to other people) as described by rosenberg and mccullough ( ) . statements about what should or should not happen at a broader level in institutions are more a reflection of the type of mattering known as societal mattering, which was a theme introduced by fromm ( ). people can be evaluated in terms of how much they feel they matter to others and to society. societal mattering is also quite important; indeed, many older people could feel like they are experiencing "double jeopardy." the person who does not feel significant to specific others and who does not feel significant to the broader community or society is someone who is at considerable risk in terms of both one's mental health status and physical health status. there is a third type of mattering known as "existential mattering" that is also distinct and involves assessments of whether one's life matters (see george and park ) ; this issue is also of relevance to many older adults and will be addressed in our discussion of meaningcentered research with older people. as suggested above, people know how it feels to them when they have been treated like they do not matter, so it should be easy to understand how many older people are feeling right now. our interest in the health and well-being of older people and their concerns are longstanding; we have conducted research over the past two decades on the risk and resilience factors associated with suicide and suicide ideation among older adults (heisel and flett , ; . this work has also resulted in the creation of the first measure of suicide ideation tailored specifically to the needs and lives of older people, the geriatric suicide ideation scale (heisel and flett ) , which assesses sociocultural and existential factors (i.e., its "loss of personal and social worth" and "perceived meaning in life" subscales) in addition to thoughts and wishes to die and for suicide. recently, concerns have been expressed about an anticipated spike in suicide behavior and deaths among older adults as a result of the pandemic (see wand et al. ) . the royal college of psychiatrists has just estimated that there could be a six-fold increase in suicide attempts among older adults (see hymas ) . suicide prevention researchers and public health experts have warned the public of a substantial increase in suicide rates among older adults, given covid-related increased fear and despair, restriction of physical access to social supports and mental healthcare programs, and financial anxiety due to the impact of stock market volatility on retirement savings. the spanish flu was associated with increased rates of suicide, and elevated suicide risk was reported for older adults in hong kong in the aftermath of the sars epidemic, due in part to the negative impact of physical distancing and isolation (see chan et al. ) . it is our contention that any increase will be fuelled not only by anxiety, stress, uncertainty, and isolation, but also the broader messages that convey to older people that perhaps they simply do not matter. one theme that has emerged from our research and from that of other investigators is that given the risks that face vulnerable older people, it is vitally important to promote positive protective factors and competencies that heighten their resilience and engagement and involvement. we agree with rosenberg and mccullough's ( ) contention that mattering is vital for everyone, but it may be especially vital for older people. however, mattering deserves much more focus among psychologists than it has received thus far; knowledge of whether an older person feels like she or he matters to others is fundamental to understanding this person and how life is going and how it is likely to go in the future. it is our hope that the current review and analysis will serve as a catalyst for a much greater emphasis on the role of mattering and its many potential benefits among scholars who conduct research with older adults and professionals who are in positions to implement practices and procedures to enhance their health and mental health. relevant research on mattering among older adults is summarized below. as is typically the case, these research investigations are mostly variable-centered studies that investigate levels of mattering and associations between mattering and other variables in large samples with participants who are either rapidly approaching or who have already reached the ages associated with being an older person. it is important to reiterate before launching into an overview about this research that mattering is about the individual person. that is, it is about the significance of the older person's individual story and life narrative. it is about whether the individual feels seen and heard and valued versus invisible and unheard and someone who does not count to the people in their lives and perhaps society as a whole. if mattering is as relevant as we claim it is, then it should be possible to identify themes related to feelings of not mattering or of feeling unimportant and expendable when the focus shifts to qualitative accounts of the experiences of individual people. this is clearly the case. for instance, a study of perceptions of preventive home visits yielded four categories including a mattering-based category centered around the theme "it made me visible and proved my human value" (see behm et al. ). berglund and narum ( ) interviewed women ranging in age from to years old. six categories emerged including a relationships category with content reflecting both belonging and mattering. specifically, one participant observed, "being in the company of my dear ones gives me a sense of belonging. it's nice to know that someone cares and they in turn can count on me when they need help or someone to talk to" (p. ). another analysis of long-term care environments by pope et al. ( ) resulted in residents identifying several things that made them feel significant (i.e., they mattered) versus insignificant (i.e., they did not matter). feelings of insignificance were trigged by events or treatment that evoked feelings of loss of control. feelings of insignificance are also rooted in insensitive treatment. an examination of factors contributing to loneliness included input from one longterm resident who said he was being shunned by his adult children (see roos and malan ) . his social pain is reflected in his statement that, "they don't want me anymore. i feel like i don't exist to them." other analyses point to feeling insignificant because of not being consulted about decisions that pertain directly to personal care and well-being (fetherstonhaugh et al. ) . a phenomenological analysis of suicidal tendencies among older adults by our colleague sharon moore identified themes of not mattering such as "no one cares" and "i am no longer needed" and the sorrow in the realization of "not being depended on anymore by other people" (see moore ) . these are commonly expressed themes among people who feeling insignificant and perhaps expendable. comments from participants in our study of meaning-centered men's groups (mcmg; see heisel and the meaning-centered men's group project team ) for men over the age of who were concerned about or struggling with the transition to retirement further underscore the central role of mattering in the mental health and well-being of middle-aged and older adults moving into their later years. qualitative findings from study exit interviews highlighted general themes relevant to mattering in enhancing participant satisfaction with the group experience, including being valued and respected, mutual camaraderie, fellowship, and belonging. a looming sense of missing each other was at the heart of requests to extend the sessions and find ways for group members to remain in contact. finally, the need to feel a sense of mattering was clearly evident in the responses that older people with mental health problems generated as part of a concept mapping exercise. this study by wilberforce et al. ( ) was conducted to inform the development of a new measure of quality of mental health services for older people. one category that emerged to characterize excellent services was labeled "personal qualities and relationships." this category included several references to the mattering construct such as care providers who are really interested and listen to and understand the older person (i.e., my care worker really listens to me). one elderly person made explicit reference to a worker who showed compassion and that they mattered. the essence of this concept category was a sense of humanity stemming from being treated as a real person by someone who is joining with the older person and is truly interested in spending time with her or him, and is not just passing through. collectively, these accounts underscore how mattering can be linked with joy and flourishing, but the feeling of not mattering can be associated with deep psychological pain. moreover, mattering needs to be embedded in therapy and counseling services. in general, the insights yielded from these accounts attest to the merits of future qualitative research that extensively examines the lived experience of feelings of mattering versus not mattering to others and perhaps to society. below, we describe the mattering construct in more detail and some elements that need to be added in order to more fully capture the relevance of mattering versus not mattering to older people. this description is then followed by a comprehensive overview of research conducted thus far that illustrates the benefits of mattering among older people. what is mattering? rosenberg and mccullough ( ) introduced mattering and the components that comprise this construct. mattering reflects our need to feel like we are significant and important to other people. rosenberg and mccullough ( ) focused on three components: ( ) the sense that other people depend on us; ( ) the perception that other people consider us to be important to them; and ( ) the understanding that other people are actively paying attention to us. rosenberg ( ) added a fourth component reflecting the sense that other people have expressed that they would miss us if we were no longer around. subsequently, schlossberg ( ) identified a fifth element-feeling appreciated by someone. this component emerged following interviews with adult caregivers who indicated what made them feel like they mattered to those people receiving their care. prilleltensky ( ) sees mattering as involving both the sense of having value to other people and giving value to other people; thus, mattering reflects both giving and receiving in ways that provide feelings of personal significance and importance. the notion of enhancing the self by becoming someone who matters to others was shown in a case excerpt described by karp ( ) in his book about people struggling with the sadness of chronic depression. marco struggled for years with profound depression but nevertheless had to assume the caregiver role when his mother suffered a prolonged illness and it became clear that she would never get better. when asked whether there was anything in it for him, marco replied, "it made me feel important" (p. ) and it forced him to put his own "stuff" aside for the time being. whereas a commonplace clinical response is to seek to alleviate stress from individuals struggling with depression, this example demonstrates the value in challenging clients to focus meaningfully on the needs of others rather than attending exclusively to their own emotional difficulty. most recently, killen and macaskill ( ) illustrated the relevance of giving value to others in a qualitative study of the positive life events reported by older adults. they conducted a revealing analysis of the diary entries of elderly people in order to arrive at a revised model of positive aging. one category that emerged from their analysis was being of value to others. this category involved doing something to help friends or family members or the broader community and receiving notes of appreciation from others. some entries reflected expressions of mattering. for instance, one woman noted in her diary that, "husband coming downstairs after going to bed specifically to give me a hug and kiss goodnight, what could be better to confirm that one matters!' (f ) (p. ). collectively, diary entries reflected the positive affect stemming from having value to other people. the components of mattering outlined above likely vary in their relevance according to an individual's current life stage, albeit with the caveat that all components are important to some degree. the need to feel that others depend on them is critical for older people. this observation accords with conclusions from sage scholars who point to the benefits that accrue when older people feel needed and wanted because other people are relying on them. findings of great longevity among older adults in japan who continue working into their th or th decades of life further demonstrate the very real health benefits that can accrue from feeling valued and that one has a purpose (see jenkins and germaine ). erik erikson proposed in his developmental theory that a key stage for middle-aged and older people is generativity versus stagnation. the positive resolution of this stage is care. although they did not discuss mattering per se, erikson et al. ( ) emphasized in their analysis of vital involvement that older people who show caring and engage in nurturing of younger people, especially younger family members (e.g., grandchildren), will spread feelings that clearly resemble feelings of mattering. similarly, george vaillant's ( ) classic analysis of the lives of older people who took part in the longitudinal harvard study of adult development also emphasized giving to others in ways that foster positive and mutually caring relationships in ways that benefit the self. these acts of caring can be focused on young family members but of course, in many instances, also involve caring for disabled relatives and friends. vaillant ( ) warned that it is possible for dedicated younger adults to become so engaged in providing care to aging parents that it can amount to too much sacrifice if such caregiving activities become all-consuming; he suggested that this can result in depleting the self by "giving the self away" to others. vaillant ( ) suggested that the benefits of giving to others are better and more evident when a person is older because caring for others is more self-determined and does not feel like an overwhelming obligation. similarly, erikson et al. ( ) suggested that generative acts from elderly people directed at younger family members are more beneficial when other people are shouldering the daily responsibility for younger people and older people can focus on being generative. how protective can it be to feel a sense of mattering to younger people who have come to depend on an older person? erikson et al. ( ) described an elderly woman who acknowledged during her interview that she actually refrained from taking her own life because she knew how much she was loved and admired by her grandchildren (i.e., she mattered). the feeling of mattering provides a sense of connection and comfort and a source of resilience that is a strong buffer of life problems and feelings of stress and distress (for discussions, see flett a; flett et al. ) , especially during the pandemic (see flett and zangeneh ) . we discuss this protective role in reducing suicide risk in more detail in a subsequent section of this article. we now turn to a discussion of ways to extend the mattering construct to more fully capture the relevance of mattering versus not mattering to older people. these additional ways of capturing individual differences in mattering are important from a conceptual perspective, but they also extend the potential focus of preventive interventions and open up additional directions for future research. the original conceptualization of mattering from rosenberg and mccullough ( ) focused on it as a feeling state and as a psychological need that is central to how people define themselves. a strong case can be made for the argument that the need to matter is just as important to people as are other key needs such as the need for autonomy, the need for competence, and the need for connection with others. rosenberg and mccullough ( ) discussed at length and demonstrated with their extensive data that mattering should not be equated with self-esteem. several researchers have confirmed that mattering goes beyond selfesteem when predicting key outcomes (e.g., flett and nepon ; flett et al. a flett et al. , b matera et al. ) . accordingly, any framework built around the notion that people need selfesteem should be modified to reflect that people need self-esteem but they also need to matter to other people. here it should be underscored that while the conceptual focus for the construct is on the need to matter, most existing measures of mattering such as the general mattering scale assess perceived levels of mattering to others and not the actual need to matter (for a discussion, see flett b). accordingly, research must focus jointly on the need to matter to other people and perceptions of achieved levels of mattering to other people. we contend that some other elements of the mattering construct are missing from the literature and clearly must be added in order to more fully capture what mattering and not mattering means to everyone, but especially older people. additional elements of the mattering construct are identified below. some of these elements have been discussed elsewhere, but they have not received much emphasis from a conceptual perspective until now. flett ( b) suggested originally that there is a key element of the mattering construct that has not been considered or measured thus far-the fear of not mattering to other people. flett ( b) proposed that people with a strong need to matter to others and who are also characterized by an insecure attachment style could become preoccupied with the fear of losing connections with the people whom they matter to and who matter to them. research on this facet of the mattering construct is in an early phase. casale and flett ( ) discussed at length how this fear of not mattering is especially relevant during the pandemic and how it is seemingly more germane at present than other fears such as the fear of missing out or the fear of negative evaluation. this element seems especially relevant to older people who have become isolated or socially disconnected or fearful of being forgotten as this global health crisis unfolds. elderly people who are cognizant of public statements about the expendability of whole segments of the population or the use of age as a key criterion to determine the allocation of scarce medical resources could have their general worries and levels of anxiety exacerbated by this particular fear. people who fear being alone may have also developed this fear of not mattering, and it could add to feelings of helplessness and hopelessness and perhaps resentment. this particular aspect of mattering may be especially relevant among some people who are in the process of dying. it is common to hear of people who just wanted to know that they have mattered to someone who cared about them and they have worries that this was not the case. it is not uncommon, among end-of-life care providers, to witness older adults at the end of life provide reassurance and comfort to family members who are struggling emotionally with the thought of the older person's impending death. a need for reassurance of having some significance to others should be especially salient among people who fear that they have not really mattered to anyone. a reasonable question to ask is, "what is worse-never having the sense of mattering to others or feeling a sense of mattering to others but then losing it?" a key element of the mattering construct that has received almost no attention thus far is the loss of mattering to others. elderly people who live long enough to outlive others and, as a result, experience loss of mattering via their losses can become very dejected if they have not found ways to maintain a sense of mattering or to still feel good about having mattering to the departed. there are many ways for older people to experience a loss of mattering to others. this may take the form of becoming a caregiver to young grandchildren who have parents employed full-time outside the home and then feeling no longer needed when these grandchildren are old enough to take care of themselves. complex family situations involving divorce and conflict may also result in a reduction in opportunities to matter for those older people who are no longer included in family activities. alternatively, a loss of mattering could take the form of losing physical mobility and no longer being able to fulfill an active volunteer role. and, of course, it could involve the loss of perceived mattering that results when an older person transitions to retirement and no longer feels important and significant to others, perhaps along with a loss of a sense of purpose. these transitions can be felt acutely by the older people who still very much need the sense of validation that is derived through mattering to other people. the loss of mattering can contribute to depressions that are due not only to loss of mattering but also a perceived loss of self. this observation fits with the many case examples of extremely depressed people who acknowledge that they no longer feel like their old selves and their first goal is to feel like themselves again. although they may not realize it, this translates into again having a feeling of mattering to others. as noted earlier, our geriatric suicide ideation scale contains a component subscale that assesses the perceived loss of personal and social worth. this factor is highly associated with a host of negative psychological factors, including depression, hopelessness, loneliness, and suicide ideation (e.g., heisel and flett . pearlin and leblanc ( ) stand alone as the only researchers thus far to focus extensively on the loss of mattering. their focus was on bereaved caregivers. their research showed that the death of a dependent relative (a spouse or parent with dementia) among caregivers resulted in a loss of mattering and contributed to depression, and the greater the loss of mattering among caregivers, the greater their level of depression year later (pearlin and leblanc ) . what is especially important about this finding is that it suggests that it is not simply a loss of activity or change in routine or sadness about having lost a loved one that is associated with depression, but rather the loss of connection, of feeling needed, and of mattering to others. we will conclude this segment by newly proposing another aspect of the mattering construct that applies universally but seems essential among older people. a fifth element of the mattering construct that is worth considering involves personal assessments of whether an individual who needs to matter sees herself or himself as someone who perhaps does not currently have a sense of mattering, but still feels that they are capable of engaging in behavior that will generate feelings of mattering to other people. this aspect of mattering can be regarded as a specific type of self-efficacy reflecting the perceived capacity to generate feelings of mattering by engaging with other people or contributing to the community in meaningful ways. this emphasis of a specific type of self-efficacy is suggested in general by research attesting to the protective role of other specific ways of framing self-efficacy among older adults (e.g., paggi and jopp ; stephan et al. ) . the concept of the capability to matter to others follows from a line of investigation in the personality field that began when wallace ( ) observed astutely that certain personality characteristics could be measured as abilities or capabilities. capabilities focus on what is possible or feasible versus what is typical, which is what personality traits tend to reflect. there has not been extensive research on personality capabilities despite their clear relevance to understanding people and the individual differences among them. one key exception is the work by martin ( , ) , who illustrated the usefulness of assessing personality capabilities in the interpersonal domain. they showed that capability and trait ratings of interpersonal characteristics are relatively orthogonal, and both capability and trait ratings are associated with low self-esteem and anxiety. the implications of these findings are clear: individual differences in trait ratings and capability ratings are quite different in their nature. similarly, just as it is possible to distinguish such things as a person's usual level of agreeableness and their capability of being agreeable, both subjectively and objectively, it should also be possible to distinguish a person's degree of mattering to others and their capability of being someone who could matter to others. it is likely that the perceived capability to matter to others overlaps to a substantial degree with feelings of loss of mattering. conceptually, it stands to reason that believing that one can still matter to others should moderate the negative impact of diminished feelings of mattering on depression and other negative psychological outcomes. some people will feel both a loss of mattering and a diminishment in their perceived capability to matter to others, perhaps as a consequence of having physical or cognitive declines that impact their ability to interact with other people. fazio ( ) has discussed how mattering to others can be impacted by personal circumstances and limitations that can also limit the frequency of positive social interactions. hopefully, such individuals will have people in their lives to whom they matter, and these people will be able to continue to demonstrate that they care about them and will take care of them. the next segment of this article consists of a review of existing research with an emphasis on mattering among older people. there are now enough articles on mattering among older people to get a clear sense of how mattering protects older people who have it and disadvantages those older people who do not feel like they matter to others. we then conclude with an analysis of applications in the form of preventive interventions and a discussion of directions for future research. our research review focuses on four topics. first, we examine the role of mattering in protecting against loneliness and social disconnection. next, we summarize research confirming that there is a negative association between mattering and depression. third, in keeping with a positive psychology orientation, we consider research illustrating the positive association between mattering and psychological well-being. finally, mattering is examined in terms of its role in positive physical health outcomes. results linking mattering with greater life satisfaction are also highlighted. most of the research investigations conducted on mattering in the elderly fit into these themes with the exception of some work examining the role of religiosity and mattering among older people (see lewis and taylor ; schieman et al. ) . loneliness is a serious problem facing many elderly people, and there are indications from extensive research that loneliness exacts both a devastating mental toll and a physical toll on older people. empirical research has supported the position that loneliness not only contributes to health problems, it may actually be a causal factor in early mortality (see holt-lunstad et al. ; luo et al. ) . fromm ( ) first discussed the association between being and feeling isolated and feelings of not mattering in his book escape from freedom. he proposed that individuals who achieve a sense of freedom from others also pay a price in terms of feeling both isolated and insignificant (see fromm ) . combined feelings of loneliness and of not mattering can be dangerous; this should especially be the case for exceptionally lonely older people who feel like they do not matter. this is just one of the many reasons why the situations brought about or exacerbated by the global health crisis may prove lethal for many older people. research on mattering and loneliness is quite limited. the most extensive study was conducted by flett et al. ( a, b) . this research with a sample of university students showed that lower scores on the general mattering scale (gms) were associated with loneliness and this association was quite robust (r = − . ). moreover, feelings of not mattering and loneliness were both associated with reports of various forms of childhood maltreatment. other analyses of this cross-sectional data yielded support for mattering as a mediator of the link between childhood maltreatment and loneliness. work is continuing in our lab on the link between feelings of not mattering and loneliness and the initial evidence continues to suggest a strong link between these interpersonally-based psychological factors. how are these factors associated among the elderly? initial evidence of a strong negative association between feelings of mattering and loneliness came from an investigation by kadylak ( ) of adult internet users years or older with a mean age of . years. the main focus of this work was to examine reactions to "phubbing" which is the tendency to focus on technology in a way that also involves ignoring someone else. low mattering would exist if an elderly person (or anyone) was being ignored by someone absorbed in technology. mattering was assessed by the -item mattering index by elliott et al. ( ) . the measures also included an eight-item loneliness scale and measures of self-reported health, depression, and the five-item satisfaction with life scale (diener et al. ) . the depression results from this study are reported in the next section. analyses established that mattering was linked robustly with lower levels of loneliness and higher levels of life satisfaction. interestingly, although it was not associated significantly with self-reported health status, levels of mattering were significantly lower among participants with lower levels of socioeconomic status and among those who were widows or widowers. lower mattering was also linked with more frequent family phubbing expectancy violations (i.e., attention of others was expected but not obtained). finally, mattering mediated the link between intergenerational family phubbing expectancy violations and loneliness. evidence of a link between low mattering with less social connection was provided in a study by francis et al. ( ) . they examined how the frequent use of informational communication technology (ict) can enhance the functioning of older adults in retirement communities. this was an extensive project that was part of a randomized control treatment study with five waves of data collection. the participants were older adults with a mean age of . years. mattering was assessed with the five-item gms (marcus and rosenberg ) . a negative link was found between mattering and assisted living, suggesting perhaps that mattering becomes diminished as a function of age-related declines in functioning. this interpretation seems consistent with the experience of older adults in residential care who are allowed to soil themselves before being assisted in toileting by on-site support workers; it is hard to conceive of a clearer message that one does not matter than to be subjected to this sort of indignity. the main analyses showed that higher levels of mattering were associated with more extensive ict use. it was also linked positively with a self-report measure of social network connectedness known as the lubben social network scale (see lubben and gironda ) . mediational analyses established further that social network connectedness mediated the association between ict use and mattering in this sample of elderly people. collectively, initial research with older people suggests that any links proposed between feelings of not mattering and feelings of isolation and social disconnection are well-founded. research with a lifespan perspective is now needed to examine mattering and loneliness from a longitudinal perspective. some complex associations likely exist, especially if mattering is studied with an extended scope that includes the fear of not mattering and the perceived loss of mattering. the predominant clinical research focus thus far in the mattering field has been on the negative association between mattering and depression. flett ( b) summarized numerous reasons why lower mattering to others should be associated with higher levels of depressive symptoms. an association would be expected given the negative self-worth judgments that are common to both. also, people with low levels of perceived mattering should have less perceived and actual social support which could have provided a buffer from depression. dixon ( ) conducted the initial study of mattering and depression in the elderly. a sample of older adults ( men, women) completed a -item measure of mattering developed by the author. the participants had a mean age of . years. dixon ( ) only reported the results for the overall score on this mattering measure even though it was comprehensive and assessed global mattering, but also mattering to significant others and friends and other family members, including any grandchildren. dixon ( ) found that mattering was linked robustly with less depression (r = − . ). other results from this study are reported in a subsequent segment of this article. chippendale ( ) also evaluated the link between mattering and depression on a smaller scale in a sample of older adults from four senior's residences in new york city. mattering was assessed with a single but highly face valid item (i.e., i feel valued and important). this item was taken from the duke social support index (koenig et al. ) . participants also completed a brief one-item measure of self-reported health status and the full version of the geriatric depression scale (gds: yesavage et al. ). the one-item measure of mattering (i.e., feeling valued and important) was associated negatively with depression (r = − . ). secondary analyses indicated that among those people who were severely depressed according to the gds cutoffs, it was the case that none of these people indicated any level or degree of agreement with the mattering item (i.e., no person with depression felt a sense of mattering). another study by wight et al. ( ) of gay identified men from the usa further illustrated the role of mattering in reduced levels of depression. the authors noted that their focus on mattering stemmed in part from reports found commonly among aging gay men of feeling invisible to other people. their participants had been part of a longitudinal study conducted over three decades, but wight et al. ( ) focused on data collected in and . the average age of participants was . years with an age range of to years. overall, % of the participants were hiv-negative. mattering was assessed with the gms (marcus and rosenberg ) . other measures in the study included a measure of internalized gay ageism with items such as "aging is especially hard for me because i am a gay man." depression was assessed with the ces-d depression scale (radloff ) . the ces-d was administered many times over three decades and this enabled the researchers to identify five depression trajectories. these trajectories were controlled for in subsequent statistical analyses. the results of a regression analysis predicting the most recent ced-d score found that elevated depression scores were uniquely and significantly associated with lower levels of mattering and higher levels of internalized gay ageism. other analyses pointed to mattering as a mediator of the link between internalized gay ageism and depression; that is, higher levels of gay ageism were associated with lower mattering which, in turn, was associated with higher levels of depression. no support was found for mattering as a moderator variable. another study of functional limitations by redmond and barrett ( ) included data on mattering and depression. this longitudinal study of over adults from miami-dade county in florida found that lower scores on an extended version of the general mattering scale were associated with depression and increases in depression over time. this study is relevant because it had a broad representative sample with participants from three age groups ( - years, - years, and - years) who had a mean overall age of . years. finally, the study by kadylak ( ) described above on reactions to phubbing among internet users also included a two-item depression scale. it was found once again that mattering was associated robustly with lower depression. as noted earlier, the study by dixon ( ) of elderly adults also included indices of wellness and purpose in life. wellness was examined only as a total score. the correlational analyses conducted by dixon ( ) found that mattering was linked with purpose in life (r = . ) and with overall wellness (r = . ). it is especially noteworthy that a regression analysis predicting overall wellness showed that mattering, purpose in life, and depression all were significant, unique predictors, suggesting that mattering is neither simply a synonym for purpose in life or wellness, nor the opposite of depression, but is an unique variable in its own right. myers and degges-white ( ) examined mattering and levels of wellness among older adults in a retirement community. the participants were residents ( men, women) who ranged in age from to years old and who had a mean age of years old. perceived stress was also assessed. mattering was assessed with the five-item gms (marcus and rosenberg ) . wellness was assessed with the five-factor wellness scale (myers and sweeney ) which taps domains of wellness and provides measures in total. correlational analyses found that mattering was not associated with perceived stress, but it was associated significantly with overall levels of wellness (p < . ). overall, mattering had significant positive links with of the individual measures of wellness. a third study by piliavin and siegl ( ) reported findings from the wisconsin longitudinal study. this long-term study began decades earlier. the report from piliavin and siegl ( ) examined a large sample of participants who were assessed in when they were approximately years old. the main focus of this work was to evaluate the potential benefits over time of volunteering. mattering was assessed with six items from the mattering index by elliott et al. ( ) . well-being was assessed with five-item or six-item subscale measure of ryff's ( ) well-being scale. it was a composite well-being measure comprised of four subscales tapping self-reported environmental mastery, purpose in life, personal growth, and self-acceptance. the results showed that even when controlling for levels of well-being when assessed in , it was the case that greater subsequent psychological well-being was predicted by mattering and a host of other factors, including social integration, years of education, and being female. other analyses suggested that social integration mediated the link between volunteering and well-being, and mattering mediated the link between volunteering and well-being. it was concluded that when someone does not have a high level of social connection, direct engagement in volunteering can boost well-being and this is underscored, at least in part, by an enhanced feeling of mattering to others. mattering should be protective in terms of physical health because it should act as a stress buffer, especially following interpersonal stressors that involve negative social exchanges (for a discussion, see fazio ). similarly, mattering should be associated with positive health behaviors and self-care to the extent that people who perceive that they matter to others have internalized this perception and so feel that they matter to themselves. the study by chippendale ( ) described above that was conducted with participants included a one-item assessment of self-reported health status. the one-item measure of mattering had a positive association with health status (r = . ), but this association did not achieve statistical significance. this could reflect the small sample size and the reliance on single-item measures. kadylak ( ) also did not find a link between mattering and a brief measure of health status. however, the study of ict frequency by francis et al. ( ) described earlier also included a one-item measure of self-reported health status; mattering was associated significantly with higher health status among these participants. fazio ( ) described the results of the first assessment point from the aging, stress, and health study (ash) in a published chapter on mattering. the initial assessment was based on adults who were years or older from washington and two counties in maryland. participants were categorized as young-old ( - ), old ( - ), and old-old ( or older). four items were used to measure mattering in terms of importance to other people and another four items assessed other people depending on and counting on the person. it was found that levels of mattering decreased significantly with age; both mattering components were significantly lower in the old-old group versus the young-old group. most noteworthy for our purposes was the finding that better self-reported physical health status was linked positively with the two facets of mattering. also, engagement in volunteer roles was also associated with higher levels of mattering. hence, remaining engaged in physical activities and in doing for others overcome the negative impact of aging on perceptions of mattering. the most relevant research conducted thus far suggests that mattering may help reduce the impact of "the wear and tear" on the body at a precise time when people are increasingly susceptible to the onset of disease and major illnesses. a key investigation by taylor et al. ( ) examined adults from tennessee. they ranged in age from to year olds. the sample included people between the ages of and years old and another people who were years old or older. they were evaluated on levels of allostatic load across physiological indicators. these indicators contained various objective measures (e.g., blood pressure, cholesterol, high-density lipids, etc.). participants also reported chronic health conditions. the mean level of chronic health conditions for the sample was . . the analyses found that age is associated with increased allostatic load, and this association is substantially greater among adults with low or moderate levels of mattering. these data suggest that a sense of not mattering plays an increasing role in poor physical health outcomes among older adults. ironically, with worsening health, the interpersonal others with whom older adults increasingly spend their time are healthcare providers; clinicians who work with older adults are thus strongly encouraged to be sensitive to, and seek to enhance, their older clients' feelings of mattering. analyses of chronic health conditions found that age was associated with more chronic health conditions, as would be expected, but mattering was associated with fewer reported chronic health conditions. however, levels of mattering did not interact with age to predict the number of chronic health conditions. while these findings need to be evaluated in future research to determine their replicability, employing multi-item measures and larger sample sizes, it does seem that mattering plays a protective role in health functioning, especially among older adults. taylor et al. ( ) went on to conclude that, "there is reason to believe that mattering may be a better predictor of health and well-being relative to other conceptualizations of social relationships" (p. ). in particular, they posited that mattering should outperform social support in terms of health and well-being. collectively, the results summarized above paint a positive image of the older person with a sense of mattering to others but a bleak image of the older person who feels insignificant, unimportant, or worthless to self and others. much more research is needed, but mattering is clearly protective in terms of being associated with less depression and greater well-being, and there are strong indications that mattering provides a platform for better health. also, initial data suggest that older people with a sense of mattering have lower loneliness and greater social connection. these findings combine to suggest that the older person who is able to maintain and extend a sense of mattering to others is someone who should cope reasonably well with the pandemic. once again, however, the situation is qualitatively different and untenable for elderly people who feel like they do not matter to others. these tendencies should be exacerbated if this is accompanied by the feeling of not mattering to the community or the broader society. flett et al. ( ) maintained that one of the key distinguishing features of mattering relative to other psychological constructs is that mattering translates well into actions and themes that can be incorporated into practical applications with a prevention and promotion focus. the potential relevance of mattering is considered below as part of a brief overview of some existing preventive interventions for older adults designed to enhance the sense of connection and relatedness to others and decrease social isolation and psychological distress. there now has been extensive research on the social isolation of older adults and the impact of loneliness and disconnection. the extent of this focus is reflected by there being at least two separate scoping reviews of research on isolation and social disconnection (see courtin and knapp ; o'rourke et al. ) . there is little doubt that anyone stands to gain from having more positive social interactions and a greater sense of interconnectedness with other people, but this is especially the case for older people who find themselves quite isolated. below we will provide a brief description of two interventions designed jointly to enhance social connections and improve mental health. mattering could be added as a key element in each instance. van orden et al. ( ) implemented a program in rochester, new york called the senior connection as a potential way of preventing suicide among elderly people. the essence of this program is that seniors who have expressed an interest in volunteering have that interest directed toward becoming a peer companion of another senior who is vulnerable and isolated, perhaps to the extent of becoming suicidal. the conceptual premise of this work is provided by the interpersonal theory of suicide by joiner and colleagues. this is a key element because ideally prevention attempts are guided by theory and conceptualization. two main themes are at the core of this interpersonal theory. people are suicidal because they feel like: ( ) they do not belong with others; and ( ) they have become a burden to other people. a program such as the senior connection will certainly address the sense of not belonging. moreover, the senior companion can openly discuss and refute the notion that their vulnerable partner is a burden to others. where could mattering enter this picture? there is a tendency to equate belongingness with mattering, but these two interpersonal constructs are distinct. someone can feel like they belong in a group yet still feel not valued or recognized within the group. flett ( b) has also described empirical findings showing that belonging and mattering are distinct concepts in various research investigations. these results suggest that the senior connection could be reframed to place a specific emphasis on how the actions and verbal interactions that take place between companions can emphasize that both are valued. one premise guiding work on mentors and mentees is that the mentor gives value to the mentee, but the mentor also receives value as a result of having a role that makes a difference in the life of someone else. mattering is also relevant to another program being led by the second author. this intervention has received the support of the movember foundation and it is geared toward lowering suicide risk and enhancing the psychological resilience of men transitioning to retirement. it is rooted in the work conducted by the authors on the role of meaning in life in promoting psychological well-being and reducing risk for suicide among older adults (see heisel and flett ) . this program and its initial effectiveness are summarized in heisel et al. ( ) . this new paper outlines the preliminary results for the mcmg (also see heisel and the meaning-centered men's group project team ). the mcmg is a -session existentially oriented, community-based, psychological group intervention. delivery of the mcmg sessions is in community settings. recruitment is based on promoting this opportunity as a "men's group dealing with adjustment to retirement" rather than as a "psychotherapy group" in an attempt to normalize any concerns about retirement. two male facilitators lead the groups. the groups are comprised typically of men who share the fact that are all facing the transition to retirement. a full description of positive initial findings is beyond the scope of this review article. it is worth noting, however, that heisel et al. ( ) made explicit reference to the potential role of mattering, and that the theme that each participant matters is implicit in the philosophy of this humanistic-existential group. our evaluation of the topics covered throughout the program identified many points where a more extensive focus on mattering could be implemented. for instance, of course, it is a simple matter when describing the purpose of the group in the initial meeting to emphasize the theme "you matter" as a reason for the existence of the program. mattering promotion can also be nonspecific in terms of providing opportunities to be seen and heard within a context where "everyone counts." some specific session themes fit naturally with the nature of the mattering construct and how to instill a feeling of mattering in a person facing retirement. for instance, one segment examines the benefits of volunteering and becoming a mentor for someone else; mattering through mentoring is quite viable. the role of mattering can also be highlighted in sessions seven and eight that collectively address meaning in relationships, friendships, business relations, and camaraderie, and meaning in love experiences with significant others, children, extended family, and even pets. one of the final sessions is focused on meaning in life and generativity. this session also represents a platform for the theme of giving a sense of mattering to the self by giving to others. the facilitators lead participants through the "clarence challenge"-named after the angel in the frank capra movie "it's a wonderful life"-asking them to imagine that an angel has materialized in front of them and shows them a movie reel of their life, specifically focusing on all of the contributions that they have made in life and the positive impact that they have had on others. after reflecting on these contributions, and listing them explicitly on paper, they are then asked to project themselves one decade into the future and imagine that clarence the angel reappears in years' time and reveals to them all of the good that they can still do. they are specifically invited to "focus on the lives you will have touched, the value you will have contributed to the lives of those around you, whether your family, friends, neighbors, community, or even strangers. then mark down (below) the impact that you can still make on the world around you over the coming decade." this highlights the facet of mattering that involves the perceived capability or capacity to matter to others, both now and in the future. it goes without saying that positive group experiences should foster the development of bonds among group members who come to matter to each other. this appears to be the case, as some former group members have continued socializing with one another following the end of the group, including one group that has been meeting on a monthly basis for nearly years following the end of their group; ironically, their most recent scheduled breakfast meeting was canceled due to covid-related prohibitions against group get-togethers. although it is beyond the scope of this review, the most recent mcmg group was temporarily halted due to covid; however, following receipt of research ethics approval, this group was reconvened online to positive effect. as suggested above, regardless of the specific content that comprises an intervention, we feel that there is much to be gained by highlighting the mattering theme prior to implementing an intervention so that participants understand that they are valued and their involvement is truly appreciated. it goes without saying that this value needs to be shown and lived rather than merely mentioned. this sense of being significant will resonate with those older people who have been feeling ignored or discounted. it should certainly be "music to the ears" of any older people who is troubled by messages and events during the pandemic that make them feel expendable and disposable rather than valued and cherished. numerous topics for future research have already been outlined in earlier segments of this article, so we will focus on only a few key themes that merit much more investigation. some of the work outlined below would benefit from a general approach that pits mattering versus other related constructs (e.g., belongingness, social support) in order to further establish the uniqueness and predictive utility of mattering. first, and foremost, the literature on the role of feelings of not mattering in suicide risk is beginning to build but, to our knowledge, there has not been research thus far focused on the potentially protective role of mattering among older people. research is imperative given growing concerns about suicidal tendencies among older people, especially during the pandemic. some studies have provided indirect evidence of the proposed association between mattering and lower suicidality, but programmatic research from a longitudinal perspective is urgently needed. regarding this indirect evidence, one study linked family connectedness with reduced suicide ideation among older adults (purcell et al. ) . measures of connectedness often include item content that assesses mattering (see flett b) . in this instance, family connectedness was assessed with a four-itembased measure of family-based reasons for living. our anlysis indicated that one of these items is directly relevant to mattering (e.g., my family depends on me and needs me), while two of three remaining items constitute indirect indicators of mattering (i.e., would be missed by others). another investigation established links between measures of belongingness and reduced suicide ideation among older adults (mclaren et al. ). once again, however, the two belongingness measures each had a small subset of items reflecting mattering to others (e.g., have felt valued in the past). thus, the results actually signify that lower suicide ideation is linked with both mattering and belongingness. the study above on family connectedness was based on a four-item measure comprised of items designed to tap reasons for living. this is noteworthy because one way to frame mattering is to consider it as a core reason for living, and research findings support reasons for living in promoting optimism and reducing risk for suicide among older adults (e.g., britton et al. ; edelstein et al. ; hirsch et al. ). accordingly, one possibility for future research is to incorporate mattering as a key theme in existing measures of reasons for living. this fits with the results of a qualitative analysis indicating that the feeling of not mattering was identified as an overarching theme among elderly people with a desire for a hastened death (see van wijngaarden et al. ) . finally, rosenberg and mccullough ( ) observed that mattering is especially important when people are facing a transition, and as such, it seems evident that more research is needed on the role played by mattering as people continue to age and they undergo a variety of impactful transitions. the focus thus far has been on mattering and retirement and there is a clear need for programmatic research on mattering and retirement; additional important moments of transition can include downsizing one's home or moving into a residential care home; experiencing health-related changes, widowhood, or other significant interpersonal losses; and anticipation of one's own mortality. schlossberg ( ) also proposed "the mattering recipe." it has four ingredients: ( ) getting involved and staying engaged, ( ) harnessing the power of invitations, ( ) taking initiative, and ( ) doing your best to make others feel like they matter. initial evidence attests to the benefits of mattering for retired workers. froidevaux et al. ( ) described a longitudinal investigation with retirees. gms scores were associated with positive affect, life satisfaction, and social support, and mattering was a mediator of the link between social support and positive affect. froidevaux et al. ( ) concluded that preventive efforts to enhance retirement adjustment should feature the mattering theme. in summary, the current article examined mattering and the need to feeling valued and significant and contrasted it with feelings of expendability among older people in usual times and in times of crisis such as the current global health pandemic. it has been mentioned often that the arrival of covid- has brought existing gaps and systemic problems into the light; we suggest that it has also illuminated a mattering gap. there is a clear need for older adults to be treated in ways that enhance their sense of mattering and enjoy the benefits of feeling significant and important rather than feeling expendable and disposable. this extends to the need to substantially increase the resources available to our older people, including training more mental health professionals to address the needs of older people who do not feel like they are priorities. humanistic approaches may be particularly consonant with such an approach, and we have outlined elsewhere the potential value of humanistically oriented interventions in enhancing well-being and reducing risk for suicide among older adults (heisel and duberstein ) . the facets of the mattering construct were described in this article and elements of the construct relevant to older people requiring much more attention were identified (e.g., the fear of not mattering and the loss of mattering). research was summarized which shows consistently the ways in which mattering is protective in terms of its links with higher levels of wellbeing and lower levels of depression and loneliness. mattering was also considered in terms of its link with physical health and its adaptive role as a buffer of the link between stress and physical health. the findings are generally in keeping with the premise advanced by rosenberg and mccullough ( ) that mattering is especially relevant among older people. it is vital for individuals, professionals, and communities to promote experiences of mattering among older adults so that our seniors can benefit fully from an enduring feeling of mattering to others and to society in general. it is our hope that this review and analysis will serve as a catalyst for a much greater emphasis on mattering as a way of promoting resilience among the elderly. we also hope it will serve as impetus for further research and applications that document how older people benefit enormously from chronic exposure to settings and situations that reinforce how much they matter and in which they know they are cherished. funding information gordon flett was supported by the canada research chairs program. this work was supported, in part, by funding from the movember foundation to the authors. covid- and the consequences of isolating the elderly. the lancet public health preventive home visits and health -experiences among very old people covid- and long-term care policy for older people in canada 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memory self-efficacy as mediators in the relation between subjective age and life satisfaction among older adults military teams raise concerns about conditions at ontario care homes -year-old coronavirus survivor: the elderly are the forgotten ones of society hospitals in peru's capital won't admit elderly patients sickened with covid- into overcrowded icu wards due to their "risk of morbidity aging well: surprising guideposts to a happier life from the hallmark harvard study of adult development the senior connection: design and rationale of a randomized trial of peer companionship to reduce suicide risk in later life ready to give up on life: the lived experience of elderly people who feel life is completed and no longer worth living covid- : the implications for suicide in older adults internalized gay ageism, mattering, and depressive symptoms among midlife and older gay-identified men the patient experience in community mental health services for older people: a concept mapping approach to support the development of a new quality measure many failures combined to unleash death on italy's lombardy development and validation of a geriatric depression screening scale: a preliminary report calls for inquiry into "horrific" covid- deaths at australian nursing home key: cord- -qnkqckvm authors: yang, li; sun, li; wen, liankui; zhang, huyang; li, chenyang; hanson, kara; fang, hai title: financing strategies to improve essential public health equalization and its effects in china date: - - journal: int j equity health doi: . /s - - -x sha: doc_id: cord_uid: qnkqckvm background: in , china launched a health reform to promote the equalization of national essential public health services package (nephsp). the present study aimed to describe the financing strategies and mechanisms to improve access to public health for all, identify the strengths and weaknesses of the different approaches, and showed evidence on equity improvement among different regions. methods: we reviewed the relevant literatures and identified articles after screening and quality assessment and conducted six key informants’ interviews. secondary data on national and local government health expenditures, nephsp coverage and health indicators in – were collected, descriptive and equity analyses were used. results: before , the government subsidy to primary care institutions (pcis) were mainly used for basic construction and a small part of personnel expenses. since , the new funds for nephsp have significantly expanded service coverage and population coverage. these funds have been allocated by central, provincial, municipal and county governments at different proportions in china’s tax distribution system. due to the fiscal transfer payment, the central government allocated more subsides to less-developed western regions and all the funds were managed in a specific account. several types of payment methods have been adopted including capitation, pay for performance (p p), pay for service items, global budget and public health voucher, to address issues from both the supply and demand sides. the equalization of nephsp did well through the establishment of health records, systematic care of children and maternal women, etc. our data showed that the gap between the eastern, central and western regions narrowed. however the coverage for migrants was still low and performance was needed improving in effectiveness of managing patients with chronic diseases. conclusions: the delivery of essential public health services was highly influenced by public fiscal policy, and the implementation of health reform since has led the public health development towards the right direction. however china still needs to increase the fiscal investments to expand service coverage as well as promote the quality of public health services and equality among regions. independent scientific monitoring and evaluation are also needed. over the past years, the public health system in china has made significant progress to enhance health for the entire population. after the founding of the people's republic of china in , the chinese government made various innovations for better delivery of public health services. for example, at the beginning of s, china launched a village doctor training program to create a front-line workforce, providing public health services and essential medical services including clinical treatment and drugs [ , ] . in addition, disease prevention and primary care were the two most important tools at that time and people were able to receive some basic vaccines to prevent infectious diseases. all of these interventions lead to great health outcomes in china [ ] . however, the public health system was ignored due to the transition from the planning economy to the market economy in the s and s. the government funds in the public health sector declined, which led public health institutions to generate their own revenues (i.e. selling vaccines, providing more profitable services) [ ] . some infectious diseases such as tuberculosis (tb), re-emerged as a result of poverty and health inequities [ ] [ ] [ ] . fortunately, the chinese government eventually realized that issues in the health care system must be addressed (particularly public health) and made various corrections. after the severe acute respiratory syndrome (sars) pandemic, the chinese government paid more attention to public health and allocated more funds to public health sectors. in the health care reform policy, an essential public health package, including nine types of basic services and six types of catastrophic services, was launched. the pcis including community health care centers, township hospitals and village clinics provided basic services and the specialized public health institutions like centers for disease control (cdcs) provided catastrophic services. the government regulated the guideline for basic services and provided training for public health workers. the financial supports were shared by the central and the local governments. until , the package included types of basic services and seven types of catastrophic services. the budget per capita for basic services increased from renminbi (rmb) in to rmb in . almost every chinese citizen has equal access to this essential public health package. by summarizing china's experiences and lessons learned during development of both public health service systems and financing strategies, especially with regard to improving universal access, the present study will provide significant policy implications for public health development and health systems strengthening in other developing countries. health equity analysis was often used to assess the improvement of healthcare or public health equalization, which is concerned with four focal variables: health outcome, health care utilization, subsidies received through the use of services and payments people make for health care [ ] [ ] [ ] . the equity analysis methods include lorenz curves and gini coefficients, thiel index, the index of dissimilarity(id), the slope indices of inequality(sii), relative index of inequality(rii) and concentration index(ci) [ ] . since the policy has been implemented for only years, the process indicators instead of health outcomes will be mainly considered for effects measurement. because of data availability, we just measure the financing equity of essential public health services and summarize the experiences and lessons by using mixed methods. based on the theory of change, we formed a theoretical framework of public health financing. policy contents, including financing strategies for fund collection, management, and allocation, which could provide incentives for both the supply side and demand side and finally influence the outcomes and impacts. contextual factors will indirectly contribute to outcomes by affecting the policy contents (fig. ). the review included studies concerning china' public health equalization in either chinese or english on databases of pubmed, medline, china national knowledge infrastructure(cnki), and wan-fang data. in addition, the review is confined to studies concerning financing strategies which improve access to public health and health outcome from to in china. the keywords are:" public health equalization" or "public health" or "primary healthcare", and "revenue collect", or"fund collect" or "revenue manage" or"fund manage" or "revenue allocate" or "fund allocate" or "financing mechanism" or "health finance", and "population coverage" or "coverage rate" or "service content" or "service package" or "service items" or "access" or "availability" or "cost sharing" or "out of pocket" or "financial risk protection" or "catastrophic spending". policy articles or other documents and reports on public health revenue collection, management, allocation, or financing strategies for improving access to public health for all were included. two reviewers identified titles and abstracts of all articles from the search, and retrieved the full text articles. finally, we obtained a total of literatures studies after data screening. the following literature information has been collected from relevant studies including background, content, mechanism and effect of the policy interventions. the main results and conclusions in the reviewed studies have been extracted. we used mixed-method syntheses to summarize successful financing strategies to improve access to public health for all in the past years especially since nephsp policy in china [ , ] . we interviewed six experts in the public health field with semi-structured questionnaire, including two officials from china national health and family planning commission, two experts from national health account department at china national health development research center, one director from china community health association and one director from expand preventive immunization(epi) department in china cdc. . - h were spent for each interview. the questions for interview include: ( ) how long has you worked there? what was your duty at that department? ( ) why did china implement the public health equalization policy? ( ) what are the changes in public health? ( ) how was fund collected, managed and allocated? ( ) what were the provide side and the demand side's responsiveness on this policy? ( ) what are experiences or lessons for the policy implementation, which aspects still need improvement? we recorded it, coded it and conducted qualitative content analyses. we collected data from china health statistics yearbook, years of new china yearbook, national health service survey report, national health financial report, national health account report and global burden of disease (gbd) database by institute for health metrics and evaluation (ihme) at washington university in st. louis, united states. in addition, we searched secondary data on some non-governmental organizations (ngo) and government websites [ ] . by collecting data from above statistic reports and websites, we could show evidences on equalization process for essential public health financing and health indicators improvement since . we used gini coefficients through the slab method to assess the total financing equity for public health in china [ , ] . and calculated the thiel index to assess the financing equity among different regions [ ] . the results include three parts: ) reviewing the three phrases of public health financing evolution from to , ) summarizing the experiences and lessons of financing strategies learned during development of essential public health equalization and ) assessing effects on government public health expenditure, fig. conceptual framework expanded services coverage and narrowed the gap of health indicators between the urban and rural area. we generated the first part mainly by literature review, the second part based on literature review and key informants interview, and the third part based on literature review and second data analysis. equal access to basic services is one principle in the public health system of china. one of core policies is the free provision of basic public health services to all residents. with the development of the policy over the past years, china has achieved almost universal basic public health services coverage for its population of . billion with increased funding levels, expanded services, and enhanced financial equity. the experience from china can provide policy lessons for other developing countries. foundation for basic public health services: sustainable public funds as part of public health, public health financing should be responsibilities of various levels' governments. lacks of sustainable financing for public health will affect the access and equity of public health service. china has some lessons as well as experience in the past years. from to the present, china's public health financing has undergone three phases. planned economy period after the founding of the people's republic of china ( china ( - the central government collected funds to address major public health issues and launch the "patriotic health campaign", which effectively decreased mortality from infectious diseases and significantly improve health status for the entire population. the life expectancy at birth of the chinese people has been extended from years in , to years in , the world bank and the world health organization called it the "china model", characterizing this strategy as maximizing health benefits with limited costs, which could be applied across many developing countries [ ] [ ] [ ] . after national government budget reforms favoring decentralization and tax redistribution, chinese local governments failed to take full responsibility for funding the public health system. the government contribution to total public health expenditures decreased sharply. this weakened the role of pcis for the provision of public health services. in addition, the emphasis of public health institutions shifted to clinical treatment instead of prevention. without consistent financial supports from central budgets, the pcis were incentivized to become self-financing entities. because of the stagnation or even decline of basic public health service provision, some infectious diseases such as tb re-emerged [ , , ] . based on an idea of the "harmonious society", and people-centered political and social policies, the government plays more active roles in the public health system and attaches great importance to this sector again. expenditures for public health institutions and pcis are again funded by the national budget. in addition, the government has increased the overall investments in public health, enhanced the primary health care system, trained health workers, and promoted health development in rural areas [ , ] . equalization of essential public health services means every chinese citizen, regardless of their gender, age, race, occupation, place of residence, and income level, can receive the same essential public health services, as mandated and supported by the government. in view of the differences in people's needs for public health services, vulnerable groups such as low income people are given more attention [ ] . essential public health services are mainly provided by pcis including urban community health service centers (stations), township hospitals and village clinics free of charge [ ] . the current public health system in china includes a network of disease surveillance centers, professional public health institutions (such as tuberculosis dispensaries), , hospitals and , primary care facilities [ ] . in specialized public health institutions, government budgets fully cover staff salaries, construction and capital development, pooled general funds, and major public health campaigns such as control of acquired immune deficiency syndrome (aids), tb and endemic diseases. public hospitals undertake particularly required public health services that are publicly subsidized. as for pcis, the government allocates funds for human resources as well as construction and capital development by government budget. the government allocates operating funds by government purchasing service. before , the construction funds for pcis were mainly from subsidies of the central government, and the operational costs and personnel expenses were mainly from local governments' usual appropriation and medical services revenue generated by pcis themselves. the usual fiscal appropriation was not enough to pay for personnel expenses. in sichuan province, for example, the annual fund in rural areas was only . rmb per capita [ ] . the pcis lost money due to high services costs and these losses seriously affected their initiatives to provide more public health services [ ] . in , the new special funds for nephsp were added into the public health sector. the funds are managed by special transfer payments through china ministry of finance. cross uses between funds are not allowed any more by "earmarked" funding management system from top to bottom. the national, provincial, municipal and county governments allocate the funding to local fiscal sectors directly according to a per capita fund standard based on the total number of the resident population [ ] and the local fiscal sectors pay the pcis for providing public health services based on mixed payment of fix salary, pay for performance(p p) and capitation (fig. ) . details of the financing strategies for basic public health services in fund collection, management and allocation are discussed below. in , china launched the nephsp with nine items, including health records establishment, health education, immunization, child health, maternal health, geriatric health, hypertension and type diabetes management, severe mental illness management, and the surveillance and control of infectious diseases and public health emergencies. the service package has been continually expanded. in , health supervision and management was added. in , a regulation of traditional chinese medicine and tb management was added into the public health service package, which currently included a total of items (table ) [ ] [ ] [ ] . by service comparison we can see that not only the service items but also the coverage of essential public health services was expanded from to . for example, the target services group for children's systematic care extended from - years to - years. national clarification about the minimum service coverage has promoted the targeted provision of public health services and facilitated the process of assessment. in addition, local governments can add other public health services into this basic national package according to their local financial capacity and public health conditions. a national funding level was set by a standardized cost formula of each service item. the minimum funding [ , ] . the central government requires that every locality meets this minimum level, in order to guarantee implementation. province and municipality level governments can further supplement the funding level according to the content of their local basic public health service packages, cost of services and local financial capacity, which has helped to expand services in the package for many areas. for example, a study suggested that the cost of the package in beijing was rmb ( . usd) per capita in based on survey in sample centers and model estimation [ ] . national, provincial, municipal and county governments in china share responsibility for funding basic public health services, and the national government allocates more money to less-developed middle and western regions by transfer payments. the proportions contributed by governments at different levels vary among regions, partially based on local socio-economic status. funds allocated from the central government via general or special transfer payments account for % of total basic public health expenditures in western regions, % in central regions, and only - % in the more prosperous eastern regions. this helps to alleviate funding disparities and gaps in western and central regions [ ] (table ) . similarly, the provincial governments can cross-subsidize counties by transferring funds from richer to poorer areas by transfer payments. taking the minimum public health funding level of rmb per capita as an example, contributions to western regions from the national, provincial and local levels of government were rmb, rmb and rmb respectively. by comparison, only rmb was from the national government in central regions. in eastern areas, the majority of the rmb minimum came from local governments [ ] (table ) . public health funds in china are managed as 'special financial funds' , which means they are managed as ringfenced budgets with unified accounting and strict allocation by capitation. this strong transparency in allocations can effectively reduce issues of payment delay or fund misappropriation. moreover, it can help improve direct supervision of public financial departments, ensuring that disbursements are not impeded and flow smoothly and securely in the health system. there are mainly two ways in the disbursement of funds for essential public health services. the first is that central and provincial project funds are directly appropriated by the provincial finance departments to municipal and county finance departments. the county finance departments allocated funds to pcis in accordance with the results of the performance evaluation. the second is the establishment of municipal finance centralized payment accounts. municipal finance departments directly allocated funds to pcis. take tianjin city as an example, municipal and district governments match funds that are then turned in to the municipal finance centralized payment accounts and allocated directly to community health service centers. municipal finance department keep accounts alone and do not adjust the use of funds. municipal and district health boards take the responsibility of supervision [ ] . this can ensure funding allocation in place and in time. in order to avoid problems from the delay of disbursements and ensure the effectiveness of funding for basic public health services. a large proportion ( %) of public health funds are allocated by capitation at the beginning of each fiscal year. according to the performance assessment system, subsequent funds are linked to the facility's actual delivery of services, which includes organization and management, responsible use of funds, productivity in completed tasks, quality, timeliness, socio-economic benefits, sustainable impact, social satisfaction, and other metrics. these payments can therefore increase the incentives to provide basic public health services in primary health care facilities and ensure funds are spent as intended by policymakers. the special fund for essential public health services were allocated by government procurement. government procurement of public health services refers to the following two ways, government proposes specific tasks, objectives, requirements and assessment criteria, and pcis provide free essential public health services to people. the government allocated the public health fund in terms of seven kinds of financial payment methods [ ] : capitation, line budget, salary, pay for performance [ , ] , global budget [ , ] , fee for service [ , ] and public health voucher [ , , ] . actually mixed payment methods were often used in practice. the government also purchase the public health services by signing a contract with the private sector such as village doctors and the latter receive a modest subsidy for providing public health services associated with the package. the willingness of village doctors to provide public health services has been improved since the introduction of the package and a minimum subsidy, although village doctors do not find the subsidy to be sufficient remuneration for their efforts [ ] [ ] [ ] . government procurement of services and publicprivate partnerships (ppp) can improve incentives in the private sector and alleviate shortages of health workers in public facilities. before the current policy of essential public health service equalization, public funds were only available for staff salaries but not institutional management. as a result, strategic performance of the public health services suffered. after adoption of the policy, pooled government procurement of services has led to greater purchasing efficiency for public health services. health workers in pcis are additionally more motivated, because their compensations are linked to performance assessment. furthermore, the government can purchase services provided by private sector actors such as village doctors, in order to effectively alleviate public health workforce shortages. the evaluation system of nephsp policy can effectively evaluate, interpret and improve basic public health services. hu shanlian initially established the evaluation indicators for this policy by consulting with experts, relying on the conceptual framework of the health system financing [ ] . yu yong combined the evaluation indicators with "national essential public health service standards" ( edition) to effectively evaluated current policies [ ] . both process indicators and outcome indicators are used to evaluate nephsp policy. process indicators are mostly service utilization indicators, used to measure the process effects of resources allocation. outcome indicators are used to reflect the final outcomes of the resource allocation. since only years for this policy implementation, process indicators are often used in current empirical studies [ ] [ ] [ ] [ ] [ ] [ ] . the improvement of government public health expenditure equity [ ] . measured by the gini coefficient, we found that inequality in ghe fell from . ( ) to . ( ), and inequality in gphe fell from . ( ) to . ( ) . measured by the theil index, the gap of ghe between eastern, central and western areas has narrowed sharply since (fig. ) . in , adoption of standard electronic health records has reached to more than %. systematic coverage rates of public health care for children under years old and maternal women are above % (fig. ) . the coverage rate for people over years old remains at % while the immunisation rate among school-age children is above %. standard management of hypertension and diabetes has reached . million and . million patients respectively, in an equivalent to management rates of % and %. meanwhile, the standard management rate of registered patients with severe mental disorders has reached to % and % of patients covered by traditional chinese medicine health care. nine million tb patients, or % of total tb patients in china, are successfully managed. the hospitalized delivery rate among rural pregnant women has reached to % [ ] . the narrowed gap of health outcomes between urban and rural area as to outcome indicators for systematic care for children under and maternal women, the mortality for children under and maternal women decreased sharply in - , especially in rural area, after . the gaps between urban and rural areas have significantly narrowed since , as shown in fig. . as to outcome indicators for systematic care of patients with hypertension and diabetes, the mortality of ischemic stroke and ischemic heart diseases increased in - , except the mortality of haemorrhagic stroke has decreased since , and mortality of diabetes increased slightly since (fig. ) . as we know, the hypertension is the leading risk factor of haemorrhagic stroke (rr = . ) [ ] . total cholesterol (rr = . ) and triglycerides(male: rr = . , female: rr = . ) are more contributed to ischemic stroke compared with blood pressure (rr = . ) [ , ] . considering the control of dyslipidaemia is not included in the nephsp, it's easy to understand that the mortality of haemorrhagic stroke this public funding is nevertheless not enough in pcis. current workforce shortages and weakness in capacity will affect the quantity and quality of services that can be offered [ , , ] . in addition, local governments may lack the capacity to effectively assess performance in terms of productivity and/or quality. service coverage and financing mechanisms for china's migrant population (approximately million in ) also need to be improved. although many studies proved that the causal association between the public health expenditure and infant or child mortality [ , ] , some studies well summarized china's experience on public health in - [ , ] and lessons in - [ , ] , some studies assessed the effects of nephsp on service coverage and equity [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , very few studies described china's financing strategies and mechanisms for the nephsp [ , , , ] . this study could be an important contribution to the exiting literature on evaluation of public health equalization in china. china's experience of different financing strategies for public health shows that the public health sector can develop stably and sustainably only if the responsibility of governmentespecially at the national levelfor financing is emphasised. in fact, the policy of basic public health services equalization was not a novelty, but rather the re-establishment of public financing responsibility and governance in china, in order to set a mechanism for equity in financial and service provision. developing countries that rely on the national budget and/or international aid to mobilise resources for health expenditures can learn from china's experiences [ , , ] . however, it is worth noting that public health financing in china is influenced strongly by its unique national governance and public financial management. strengthening the government's leading role in public health financing the chinese national government has introduced a clear and basic service package and clarified the service content, standards, and minimum financing levels, which has led to better health sector accountability [ ] . the national government plays the main role in public health financing, and local governments should continue to be clear about their financing responsibilities. financial equity across citizens and regions can be guaranteed by transfer payments facilitated by national or provincial governments [ , ] . the national government sets policies for subsidy management, allocates central funds, and implements the management hierarchy across levels. integrated payment management to ensure full and timely funding is in place earmarked funding and allocation by capitation can increase transparency of funding levels, which can safeguard against the delay or diversion of funds [ ] . top up disbursement for actual services according to recurrent expenditure management can improve incentives in pcis [ ] . with this combination of preappropriation and later payments based on performance assessment, the process of disbursements can be accelerated to meet operational needs. moreover, government procurement of services can promote ppp, to improve incentives for private sector actors to provide public health services as a supplement to public institutions [ , , ] . according to local conditions, in terms of funding criteria as well as implementation schedule and goals, it is essential to continuously improve the health system [ ] . in a large country with significant regional diversity, the key point is to increase local governments' incentives to promote equity of basic public health services [ ] . it has been only years since the carry out of nephsp equalization policy in , it is difficult to use the data to measure the improvement of health outcomes and health equity in the public health sector. we need to use longitudinal data to capture its effectiveness in future. however based on existing evidences we could find that many process indicators has improved since which may finally result in improvement of health outcomes based on many experimental studies [ , , ] . financing strategies are essential parts in the public health equalization policy. public fiscal policies have a major effect on the delivery of essential public health service. in many middle or low income countries, people couldn't acquire or have equal access to basic public health services due to the lack of sustainable public financing, which result in major infectious diseases and endemic diseases spreading, high maternal mortality and mortality of children, finally preventing the realization of mdg. the chinese public health financing evolution proved that equalization of health outcomes depends on fiscal equalization, health financing equalization and equal access to public health services. and chinese experiences for nephsp could provide lessons for other developing countries. abbreviations aids: acquired immune deficiency syndrome; cdcs: centers for disease control; gbd: global burden of disease study; ghe: government health expenditure; ihme: institute for health metrics and evaluation; nephsp: national essential public health services package; ngo: non-governmental organizations; p p: pay for performance; pcis: primary health care institutions; ppp: public-private partnerships; rmb: renminbi; rr: risk ratio; sars: severe acute respiratory syndrome; tb: tuberculosis transformation of china's rural health care financing state council of the people's republic of china. regulation on the practicing of village doctors good health at low cost' years on: what makes a successful health system? london: lshtm china's public health-care system: facing the challenges health sector reform: lessons from china regulating health care markets in china and india expanding health insurance coverage in vulnerable groups: a systematic review of options analyzing health equity using household survey data a guide to techniques and their implementation the effect of private and public health expenditure on infant mortality rates: does the level of development matters? child mortality and public spending on health: how much does money matter? world bank policy research working paper protocol: a realist review of user fee exemption policies for health services in africa proposal: a mixed methods appraisal tool for systematic mixed studies reviews institute for health metrics and evaluations. global burden of diseases compare empirical study on the equality of public health service in china: analysis and evaluation of public health voucher in chongqing municipality thinking about years of public health in new china public health in china-is the experience relevant to other less developed nations? socsci med financing reforms of public health services in china: lessons for other nations historical evolution and current situation analysis of the construction of rural public health system in china historic evolution and 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community public health service in hunan province factors influencing the provision of public health services by village doctors in hubei and jiangxi provinces china evaluation and mechanism for outcomes exploration of providing public health care in contract service in rural china: a multiple-case study with complex adaptive systems design health providers' perspectives on delivering public health services under the contract service policy in rural china: evidence from xinjian county indices of the equality of essential public health services in china construction of evaluation index system for equalization of basic public health services china's rural public health system performance: a cross-sectional study differences and determinants in access to essential public health services in china: a case study with hypertension people and under-sixes as target population public health in china: the shanghai cdc perspective essential public health services' accessibility and its determinants among adults with chronic diseases in china determinants of basic public health services provision by village doctors in china: using non-communicable diseases management as an example evaluation of health care system reform in hubei province, china national health and family planning commission progress report of the state council on deepening the reform of health system subtypes of hypertension and risk of stroke in rural chinese adults guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the challenges of basic public health services provided by village doctors in guizhou, china revisiting current "barefoot doctors" in border areas of china: system of services, financial issue and clinical practice prior to introducing integrated management of childhood illness (imci) research on the fiscal policies of equalization of basic public health services in hebei province dr. meng qingyue is the pi of this study and provides guidance and supervision to the study design, analysis and manuscript writing. the dataset supporting the conclusions of this article is included within the article. all authors read and approved the final manuscript.ethics approval and consent to participate not applicable. all authors jointly contributed to the design, analysis, and interpretations of results. all authors read and approved the final manuscript. the authors declare that they have no competing interest.• we accept pre-submission inquiries • our selector tool helps you to find the most relevant journal submit your next manuscript to biomed central and we will help you at every step: key: cord- - qoo a i authors: balanzá–martínez, v.; atienza–carbonell, b.; kapczinski, f.; de boni, r. b. title: lifestyle behaviours during the covid‐ – time to connect date: - - journal: acta psychiatr scand doi: . /acps. sha: doc_id: cord_uid: qoo a i loneliness and social isolation are associated with poor mental and physical health and may increase the likelihood of common mental disorders (depressive and anxiety disorders), substance use, and cognitive decline , . at this moment, people around the globe have been urged to self-isolate and refrain from social interaction due to the covid- pandemic. from public health and preventative care perspectives, there is a pressing need to provide individuals, communities and health agencies with information and interventions to maintain the healthiest possible lifestyle while in isolation. physical-distancing policies. lifestyle behaviours including dietary changes, restricted physical activity and the effect of increased indoor and screen time remain an under-researched area ( ) . of note, towards the end of the sars epidemic, social support, mental health awareness and other lifestyles changes (exercise, more time for relaxation and restorative sleep) were all associated with decreased perceived stress and incidence of ptsd ( ) . the ongoing covid- outbreak has led to an unprecedented public health crisis worldwide. from our perspective, several actions are required to minimize the transition to a social crisis with long-lasting consequences. it is time that such interventions start to include lifestyle guidelines with the aim to translate evidence into public health policies. this is crucial for the vulnerable groups, such as low-income families and children ( , ) , the elderly, socially isolated individuals and people with severe mental disorders (smd). regarding patients with smd requiring admission, the field is recommending home hospitalizations to keep patients safe while avoiding formal hospital admissions ( ) . regarding lifestyle guidelines, recent reviews have emphasized the role of maintaining a healthy nutritional status ( ) and engaging in physical exercise at home ( ) in the management of covid- outbreak. similar recommendations were made at the time of the influenza pandemic in , when public health nurses adhered to precepts of good hygiene, nutrition, fresh air and rest ( ) . however, such lifestyle guidelines are not entirely evidence based. indeed, they are basically the same guidance used during non-pandemic times. observational data on how the general public and patients with psychiatric disorders actually deal with self-care, nutrition, physical activity or restorative sleep during confinement are lacking and represent a research gap. to address such gap, observational studies of lifestyle behaviours during the compulsory isolation are timely and clearly a necessary step for the design of rational and effective public policies. such studies would provide the much-needed evidence to design interventions to prevent a new pandemic of psychiatric disorders and cardiometabolic comorbidities as proposed by the covid- snapshot monitoring (cosmo) initiative ( ) . furthermore, data collection must be fast and provide useful and reliable information in real time to health authorities, media and citizens. psychiatry and behavioural medicine may be particularly benefited from surveys and interventions carried out remotely to reach a large number of individuals in need. large-scale surveys will require international networking to address changes in lifestyle behaviours and the expected consequences after the covid- ( ) . we urge the field to embrace and extend ehealth and mobile health interventions, online monitoring surveys and big data technologies. remote data collection using social networks, georeferencing and the available tools provided by data science is available, feasible and necessary in the context of this pandemic. such tools provide the means of groups across the globe to connect and generate the realtime necessary data to inform policymakers. the authors received no financial support for the research, authorship and/or publication of this editorial. dr. balanz a-mart ınez acknowledges the support from instituto de salud carlos iii (pi / , probilife study). dr. de boni acknowledges long-term funding from cnpq and faperj. dr. balanz a-mart ınez has been a consultant, advisor or continuing medical education (cme) speaker over the last years for the following companies: angelini, ferrer, lundbeck, nutrici on m edica and otsuka. the other authors declare no conflict of interest. v. balanz a-mart ınez , , b. atienza-carbonell , f. kapczinski , r. b. de boni social isolation, loneliness and health in old age: a scoping review an overview of systematic reviews on the public health consequences of social isolation and loneliness combined impact of healthy lifestyle factors on lifespan: two prospective cohorts global, regional, and national comparative risk assessment of behavioural, environmental and occupational, and metabolic risks or clusters of risks for countries and territories, - : a systematic analysis for the global burden of disease study the lancet psychiatry commission: a blueprint for protecting physical health in people with mental illness international society for nutritional psychiatry research. nutritional medicine as mainstream in psychiatry the psychological impact of quarantine and how to reduce it: rapid review of the evidence factors associated with mental health outcomes among health care workers exposed to coronavirus disease joint international collaboration to combat mental health challenges during the coronavirus disease pandemic balanz a-mart ınez v. natural environments, ancestral diets, and microbial ecology: is there a modern "paleo-deficit disorder"? part ii physical inactivity and cardiovascular disease at the time of coronavirus disease (covid- ). eur j prevent cardiol . epub ahead of print wuhan coronavirus ( -ncov): the need to maintain regular physical activity while taking precautions positive mental health-related impacts of the sars epidemic on the general public in hong kong and their associations with other negative impacts covid- , school closures, and child poverty: a social crisis in the making. lancet public health . epub ahead of print covid- related school closings and risk of weight gain among children. obesity . epub ahead of print the role of mental health home hospitalization care during the covid- pandemic potential interventions for novel coronavirus in china: a systemic review everything old is new again: covid- and public health monitoring behavioural insights related to covid- key: cord- -d ll ka authors: alotaibi, badriah m.; yezli, saber; bin saeed, abdul-aziz a.; turkestani, abdulhafeez; alawam, amnah h.; bieh, kingsley l. title: strengthening health security at the hajj mass gatherings: characteristics of the infectious diseases surveillance systems operational during the hajj date: - - journal: j travel med doi: . /jtm/taw sha: doc_id: cord_uid: d ll ka background: hajj is one of the largest and the most ethnically and culturally diverse mass gatherings worldwide. the use of appropriate surveillance systems ensures timely information management for effective planning and response to infectious diseases threats during the pilgrimage. the literature describes infectious diseases prevention and control strategies for hajj but with limited information on the operations and characteristics of the existing hajj infectious diseases surveillance systems. method: we reviewed documents, including guidelines and reports from the saudi ministry of health’s database, to describe the characteristics of the infectious diseases surveillance systems that were operational during the hajj, highlighting best practices and gaps and proposing strategies for strengthening and improvement. using pubmed and embase online search engines and a combination of search terms including, ‘mass gatherings’ ‘olympics’ ‘surveillance’ ‘hajj’ ‘health security’, we explored the existing literature and highlighted some lessons learnt from other international mass gatherings. results: a regular indicator-based infectious disease surveillance system generates routine reports from health facilities within the kingdom to the regional and central public health directorates all year round. during hajj, enhanced indicator-based notifiable diseases surveillance systems complement the existing surveillance tool to ensure timely reporting of event information for appropriate action by public health officials. conclusion: there is need to integrate the existing hajj surveillance data management systems and to implement syndromic surveillance as an early warning system for infectious disease control during hajj. international engagement is important to strengthen hajj infectious diseases surveillance and to prevent disease transmission and globalization of infectious agents which could undermine global health security. the number of pilgrims participating in the hajj religious mass gathering has increased significantly over the years, with million pilgrims attending annually in the last years compared with in . , unhygienic practices and close contacts between pilgrims in overcrowded situations during the hajj rituals, as well as international travel, increase the risks of outbreaks and the spread of infectious diseases among pilgrims. the risk of infectious diseases transmission may extend to the local saudi population and to the home population of returning pilgrims after hajj. , this could strain the public health services in saudi arabia and may threaten global health security. historically, several outbreaks of infectious diseases have been reported at the hajj. these include an outbreak of cholera during the hajj that caused an estimated deaths among pilgrims and a number of international hajj-related outbreaks of meningococcal diseases in , and . the introduction of a number of pragmatic public health preparedness strategies for hajj, including vaccination and chemoprophylaxis and improved food safety and waste management, ensured that no outbreaks of cholera and meningococcal meningitis occurred during the event in recent years. however, both diseases remain a priority for public health control as do other infectious disease with global significance such as tuberculosis and zika virus disease. , in addition, new and emerging corona and influenza viruses, such as influenza h n virus, severe acute respiratory syndrome coronavirus and the middle east respiratory syndrome coronavirus (mers-cov) remain an ever present threat to mass gatherings such as hajj. as yet, no confirmed cases of mers-cov were reported during hajj. however, given the current outbreak of the disease in the kingdom, mers-cov continues to be a major risk during the event. effective health information management and dissemination allow the formulation of appropriate strategies to prevent and/ or control outbreaks and the international spread of diseases. the use of appropriate surveillance systems during mass gatherings ensures the timely collection, analysis and interpretation of health data for effective planning and response to infectious diseases threats. additionally, public health surveillance systems play a substantial role in providing reassurance of the absence of a deleterious public health event to mass gathering organizers and political office holders during an international mass gathering. in the context of hajj and saudi arabia, mers-cov is a case in point. thus, an effective infectious diseases surveillance system (idss) during hajj should be highly sensitive to detect infectious diseases events in a timely manner and to minimize the threats to the safety and well-being of pilgrims and their contacts after the mass gathering. in practice, several idsss are operational during hajj. a regular idss is applicable kingdom-wide and generates routine reports from the health facilities to the regional and central public health directorates of the ministry of health (moh) all year round. during hajj, this system is complemented by enhanced idsss to ensure timely reporting of event information for appropriate action by public health officials. however, there is little documentation of the components and operations of each system, their advantages and disadvantages as well as their efficiency in terms of timeliness of alerts and channels of reporting. here, we describe the characteristics of the idsss that were operational during the hajj, highlighting best practices and gaps and propose strategies for strengthening and improvement. the main hajj rituals take place on day - th of dhu-al hijjah (hajj month in the islamic calendar). the saudi moh collaborates with other organizations, such as the municipality and the ministry of hajj to ensure food and water safety, vector control, waste management and to provide other public health services during hajj. to that end, the moh conducted various risks assessments in preparation for the hajj, including an international health regulations (ihrs) public health core capacity assessment at the points of entry and disseminated the updated pre-travel advice and health requirements for pilgrims and workers involved in the hajj. the latter includes details of the vaccination requirement for meningococcal meningitis, yellow fever, seasonal influenza and polio. in line with ihr , pilgrims arriving from certain countries in africa and south and central america were required to present a valid yellow fever vaccination certificate on arrival. all pilgrims were required to present valid certificate of vaccination with quadrivalent (acyw ) meningococcal vaccine, and those arriving from countries in the african meningitis belt, were given mg of oral ciprofloxacin as chemoprophylaxis to lower meningococcal carriage rate among these pilgrims. oral ingestion of ciprofloxacin was directly observed by healthcare workers to ensure adherence. all pilgrims travelling from polio risk countries received dose of oral polio vaccine at borders points on arrival in saudi arabia regardless of age and vaccination status. the moh also recommended the administration of seasonal influenza vaccine to all pilgrims before arrival for hajj, particularly pilgrims at risk of developing severe complications of seasonal influenza, including pregnant women, elderly individuals, children aged months to years, pilgrims with coexisting medical conditions and healthcare workers. the command and control centre (ccc) is a special moh unit created in the aftermath of the mers-cov outbreak in to coordinate an appropriate response to infectious diseases outbreaks in saudi arabia. as the crisis management arm of the moh, the ccc coordinated the outbreak response plans of the moh during the hajj, establishing clearly defined interfaces between various moh departments and international organizations to ensure appropriate and timely response to outbreaks of infectious diseases. the ccc created three situation rooms at key locations in hajj sites; the health directorate of makkah region, almahbat mina and the mina emergency hospital. these sites were selected because pilgrims spend most of their time in makkah and mina, performing hajj rituals which potentially impacts on their safety and well-being. overall, pilgrims, including saudis and non-saudis from countries participated in the hajj. within makkah city and the holy areas, the saudi government provided free healthcare services through primary healthcare centres and hospitals including, seasonal health facilities only operational during hajj. the hospitals had a combined bed capacity of beds. this indicator-based idss is implemented country-wide in saudi arabia for routine facility-based notification of infectious diseases events all year round, including during hajj. each regional public health directorate is made up of - administrative sub-units known as 'health sectors'. these sub-units receive and review infectious disease surveillance data from the health facilities within specified geographical areas in the region for reporting to the regional public health directorates. the surveillance teams at the regional-level collate data pooled from the health sectors on disease-specific excel sheets for monthly reporting to the central directorate of public health at the moh headquarters. despite limited data management capabilities, this surveillance system was proven effective in detecting and triggering timely responses to outbreaks of measles and scabies in the kingdom in / and , respectively. enhanced idsss are activated during the hajj season to ensure early detection and prompt response to infectious diseases outbreaks. for the hajj, the enhanced surveillance became operational from the first dhul-qa'dah (islamic calendar month preceding hajj) with the arrival of the first batch of pilgrims, and continued until the end of moharam (first month of the islamic year following hajj) after the departure of the last group of pilgrims. this system is active at three main points: key points of entry to the kingdom, healthcare facilities in the hajj areas and medical office for pilgrims (formerly known as medical missions). each of these is described later. effective surveillance at the points of entry is required to prevent and control the international spread of diseases during mass gatherings, including the importation of infectious agents to the host country. during the hajj, public health surveillance teams trained to detect and report public health threats and to monitor the compliance of arriving pilgrims with the health requirements for the hajj were deployed at the kingdom's hajj entry points. these teams consisted of personnel at jeddah airport, at jeddah seaport and at medina airport. approximately % of international pilgrims arrive through these three points of entry. at each point of entry, the surveillance teams reviewed the vaccination status of arriving pilgrims by checking their vaccination cards, reported any cases of unvaccinated pilgrims or those with unverifiable vaccination status and recommended appropriate actions for these cases. the surveillance teams were also responsible for identifying and managing ill pilgrims, as well as the notification and transfer of suspected cases of infectious diseases. hospital-based surveillance teams were operating in each hospital within the hajj areas in . these were hospital staff trained to rapidly detect and report manually and electronically cases of infectious diseases presenting to the hospitals. suspected cases of infectious diseases identified at primary health centres were referred to pre-specified hospitals for confirmation of diagnosis, further management and notification to the ccc. the hospital teams were reinforced by fixed and mobile surveillance teams from the regional directorates to ensure -h active surveillance during the hajj. whereas each fixed team consisted of medical doctor and health inspector, each mobile team was made up of medical doctors (a male and a female), health inspector and driver. these personnel were drawn from different regional health directorates, across the country and mobilized for a -day refresher course, accredited by the saudi commission for health specialties. among other relevant topics, the refresher course was focused on discussing the current trends in the management and control of infectious diseases as well as the reporting formats and tools for infectious diseases surveillance during hajj. the fixed surveillance teams were assigned to each hospital operating in the hajj areas and reviewed admission logbooks for cases with clinical features of infectious diseases and followed up on cases admitted into the wards to identify and report suspected cases of notifiable diseases to ensure no cases were missed by the hospital surveillance teams. the mobile surveillance teams were tasked to conduct field investigations for reported cases of infectious diseases. these included active case finding and safe transfer of suspected cases to designated facilities, contact tracing, risk communication and liaison with medical office for pilgrims (see later) to facilitate case reporting and effective follow-up of contacts of cases. additionally, supervisory units composed of epidemiologists and infectious diseases specialists were established by the regional directorates to monitor the activities of the mobile and fixed surveillance teams and to serve as an intermediary between these surveillance teams and the regional directorates ( figure ). the supervisory units were also responsible for the isolation of suspected cases, follow-up of laboratory investigations and clinical status of hospitalized cases, as well as monitoring to ensure the implementation of the appropriate infection prevention and control procedures for patients, healthcare personnel and visitors. although the surveillance teams investigated all suspected infectious diseases cases, the following diseases were listed as high priority during hajj, and clear guidelines were provided for reporting suspected cases of these disease: mers-cov, ebola virus disease (evd), cholera, meningococcal meningitis, yellow fever, polio, rift valley fever, crimean fever, dengue fever, malaria, influenza and food poisoning. of all suspected cases detected by the idsss in the hajj, cases of malaria, cases of influenza h n , cases of food poisoning, cases of dengue and cases of non-meningococcal meningitis were confirmed after investigations. there were no confirmed cases of mers-cov illness, evd or cholera during the hajj season. hajj medical office for pilgrims refers to the healthcare representatives of some countries which send pilgrims for the hajj and accompany pilgrims during the event. they may set up clinics or hospitals within the hajj areas and provide healthcare services for their own pilgrims in compliance with the saudi moh rules and regulations. the composition of the medical office for pilgrims varies from country to country; however, it is recommended that a minimum of % of their staff should have a public health background. a memorandum of understanding is established between the saudi authorities and the medical office for pilgrims for effective coordination and communication of the standard public health requirements for the hajj. the medical offices are required to comply with the standard sanitary requirements for food preparation and handling, to educate pilgrims on personal hygiene and proper waste disposal and to submit a valid contract with an accredited firm for medical waste management to the regional directorates. additionally, they are required to provide daily reports on notifiable diseases, to establish isolation areas for suspected cases and to coordinate with the public health supervisory teams for the safe transfer of these cases when necessary. of the country medical offices operational during the hajj only ( %) were found to be compliant with the standard requirements of the saudi moh. the inconsistency of some medical representatives, with regards to compliance with the requirements of the moh and the frequent change of medical teams by countries sending pilgrims, often soon after the hajj limits sustainable partnership between the moh and the medical offices for pilgrims. locations. , overall, two electronic surveillance systems were operational during the hajj: the health electronic surveillance network (hesn) and the electronic statistical system for hajj referred to as citrex. hesn is a web-based electronic solution, introduced by the saudi moh to improve communication among public health professionals involved in outbreak management as well as to provide quality health data for planning and effective allocation of resources. hesn was initially implemented as a pilot in makkah region of saudi arabia in . by january , a country-wide implementation was initiated to control the outbreak of mers-cov in the kingdom. during the hajj, in addition to the traditional data capture and reporting tools, the hospital surveillance teams also collated and entered infectious diseases data directly into hesn once a notification was received from the laboratory, emergency rooms, isolation wards and other departments in hospitals. the uploaded data were immediately displayed on electronic dash boards in the ccc's situation rooms. data were analysed and reports generated in real-time that could be immediately accessed by public health officials and decision makers or disseminated through phone messages to responsible persons for immediate action. citrex is a web-based electronic solution that predates hesn and was used in the preceding hajj seasons. in hajj, this system was operational alongside hesn. unlike hesn which is implemented country-wide, citrex is used only during hajj to manage infectious diseases data captured inreal time from the health facilities in the holy areas (makkah, medina, arafat and mina). although the hospital surveillance teams handled data entry into hesn, the fixed surveillance teams captured the same health data into citrex for analysis and notification on distinct electronic dashboards at the ccc. over the years, the saudi government has allocated substantial resources to protecting public health during the hajj. this contributed to the development of modern surveillance systems for the hajj, evolving from the paper-based reporting tools to a more efficient web-based electronic surveillance systems. enhanced idsss were introduced to complement the conventional surveillance system in addressing the increased risks of infectious diseases transmission and outbreaks during the hajj. existing electronic surveillance systems (hesn and citrex) automatically generates reports and have the advantage of timeliness, as public health personnel at different locations can access and synchronize information management once data is captured at the reporting sites. however, the implication of having parallel systems capturing and interpreting the same health data has some potential implications, including duplication of work, depletion of already limited resources during hajj and uncertainty of the accuracy of the data. therefore, there is a need to conduct operational studies to assess the feasibility of integrating the diverse surveillance systems utilized during hajj into one efficient tool. prioritizing systems that remain operational for routine surveillance after hajj may promote the most efficient use of resources. furthermore, there is need to sustain the enhanced surveillance system and other public health interventions at key locations in the kingdom, including the points of entry, after the hajj, as a prevention and control strategy for the international spread of diseases during other mass gatherings with international dimensions, principally the umrah pilgrimage. it is estimated that over million pilgrims arrive to the kingdom yearly to participate in the umrah, which occurs nearly all-year round. syndromic surveillance could complement the existing notifiable disease surveillance systems, as an early warning system for public health threats during the hajj and umra mass gatherings. various risk assessments have shown that case-based notification systems do not meet the surveillance requirements for international mass gatherings, in terms of timeliness and coverage of possible risks groups. , quite often, time-consuming laboratory processes required for making diagnosis may stall the disease notification process, and hence prolong the time for initiating an intervention to a potential threat. symptomatic pilgrims who prefer 'quick-to-access' pharmacies may not present to the health facilities, eluding the current notifiable disease surveillance systems operational during hajj. syndromic surveillance uses aggregated data of symptom groups from a wide range of sources that precedes clinical diagnosis to set thresholds for responding to a threat. this kind of surveillance is also useful for dispelling or confirming rumours of outbreaks, based on changes in the reported number of aggregated cases in an area. the potential benefits of syndromic surveillance during mass gatherings were reported during previous olympic games. for example, the syndromic surveillance system implemented during the beijing olympic games improved the detection and response time to potential outbreaks during the games. additionally, the daily syndromic surveillance data captured during the london olympics and paralympic games reassured public health officials and political office holders of the absence of outbreaks, which substantially impacted on planning, and boosted the legacy of the event. thus, the moh through the global centre for mass gatherings medicine (gcmgm) and the saudi field epidemiology training programme is setting up a syndromic surveillance system for the hajj and umra mass gatherings to complement the enhanced idss, as an early warning system for public health threats. this system may become operational during the hajj. ensuring the health and safety, security and well-being of pilgrims are top priorities for the kingdom. achieving this is a collective responsibility that needs to be shared by saudi arabia and each country that sends pilgrims to the hajj. this is because the hajj experience is not limited to the few days pilgrims spend performing the hajj rituals. rather, it starts well before they arrive to the kingdom and lasts long after they have returned to their home countries. prevention of importation and exportation of infectious agents in hajj is key for global health security and effective infectious disease surveillance both in the kingdom during hajj, as well as in the countries of origin of pilgrims, is crucial in achieving this. therefore, it is apparent that there is a great need for the development of a well-structured, harmonized and effective collaboration, data collection and information sharing network involving the saudi health authorities and representatives from all countries sending pilgrims to the hajj. such a network would be crucial in strengthening infectious disease surveillance, preventing illnesses and responding to outbreaks during hajj, minimizing disease transmission as well as strengthening global health security through adherence to the ihrs, including notifiable diseases reporting to the who. for these reasons, the gcmgm in collaboration with the who intends to create this global network by the appointment of a hajj and umra focal point in each country which sends pilgrims to saudi arabia for these mass gatherings. considering the potential diplomatic and practical hurdles that may stall the implementation of such an international system, both organizations aim to prioritize countries sending the largest number of pilgrims to the hajj, and to retrain existing who ihr country focal point or who country office staff to function as focal point and to coordinate the activities of the network in each country. these focal points shall engage in public health preparedness activities such as dissemination of health education messages, monitoring pilgrims' health status and compliance with the hajj and umra health requirements, as well as routine surveillance for public health emergencies of international concern. additionally, they shall develop and maintain a database on pilgrims' demographics and health information as well as on public health threats including disease outbreaks in pilgrims' home countries. this database will allow the focal point to generate periodic and on-request reports on infectious disease to the who, the gcmgm or the local health authorities as required, facilitating the monitoring of disease patterns and trends globally and strengthening the kingdom's public health hajj preparedness and response capabilities. during the recently concluded hajj, the ministry of hajj introduced an electronic wrist bracelet, which pilgrims were urged to wear at all times during the pilgrimage. the bracelet captured salient demographic information for each pilgrim, including age and nationality, and was global positioning system (gps) enabled to track pilgrims' location and inform crowd control and risk communication priorities during the hajj. the moh is already exploring ways of incorporating vital health information, such as comorbidity, blood type and known allergies, in the electronic device to provide relevant data for health planning and improved health services delivery during future hajj. the saudi authorities have invested significant resources in developing model idsss for the hajj to ensure the safety and wellbeing of pilgrims, the saudi population and the population of countries sending pilgrims for the hajj. existing surveillance systems operating during hajj would be complemented by syndromic surveillance systems to ensure timely response to potential public health threats. since the hajj experience is not limited to the short time pilgrims spend performing the hajj in saudi arabia, there is a need for sustainable international collaborations between the saudi authorities, countries which sends pilgrims for the hajj and international organizations to strengthen infectious diseases surveillance and to prevent disease transmission and globalization of infectious agents which could undermine global health security. conflict of interest: none declared. the pilgrimage and its implications in a regional malaria eradication programme. who/emro inter-regional conference on malaria for the eastern mediterranean and european regions world health organization report who/mal/ hajj: infectious disease surveillance and control health risks at the hajj outbreak of serogroup w meningococcal disease after the hajj pilgrimage mass gathering and globalization of respiratory pathogens during the hajj a treatise on asiatic cholera meningococcal disease during the hajj and umrah mass gatherings tuberculosis and mass gatherings-opportunities for defining burden, transmission risk, and the optimal surveillance, prevention, and control measures at the annual hajj pilgrimage rapid spread of zika virus in the americas-implications for public health preparedness for mass gatherings at the brazil olympic games what is epidemic intelligence, and how is it being improved in europe olympic and paralympic games: public health surveillance and epidemiology health conditions for travellers to saudi arabia for the pilgrimage to mecca (hajj) manual of notification of infectious diseases world health organization. public health for mass gatherings: key considerations. geneva; who ministry of health. documentation of the hajj infectious diseases surveillance capacity meeting of heads of medical missions on public health preparedness for hajj enhanced surveillance of infectious diseases: the fifa world cup experience ministry of health. all-hazard health risk assessment for ministry of health world health organization. the health legacy of the beijing olympic games: success and recommendations. manila: who regional office for the western pacific key: cord- - ly d authors: clemens, vera; deschamps, peter; fegert, jörg m.; anagnostopoulos, dimitris; bailey, sue; doyle, maeve; eliez, stephan; hansen, anna sofie; hebebrand, johannes; hillegers, manon; jacobs, brian; karwautz, andreas; kiss, eniko; kotsis, konstantinos; kumperscak, hojka gregoric; pejovic-milovancevic, milica; christensen, anne marie råberg; raynaud, jean-philippe; westerinen, hannu; visnapuu-bernadt, piret title: potential effects of “social” distancing measures and school lockdown on child and adolescent mental health date: - - journal: eur child adolesc psychiatry doi: . /s - - -w sha: doc_id: cord_uid: ly d age-related metabolic and renal changes predispose older people to an increased risk of diabetes mellitus and diabetic kidney disease, respectively. as the prevalence of the ageing population is increasing, because of increased life expectancy, the prevalence of older people with diabetic kidney disease is likely to increase. diabetic kidney disease is associated with an increased risk of adverse outcomes and increased costs to healthcare systems. the management includes promotion of a healthy lifestyle and control of cardiovascular risk factors such as hyperglycaemia, hypertension and dyslipidaemia. older people are a heterogeneous group of people from a community-living fit and independent person to a fully dependent individual residing in a care home. therefore, management in this age group should be based on a patient’s functional level adopting tight metabolic control in the fit individual and relaxed targets in the frail person. however, despite the maximum available therapy, a significant number of patients with diabetic kidney disease still progress to renal failure and experience adverse cardiac outcomes. therefore, future research is required to explore methods of early detection of diabetic kidney disease and to investigate novel therapeutic interventions to further improve the outcomes.age-related metabolic and renal changes predispose older people to an increased risk of diabetes mellitus and diabetic kidney disease, respectively. as the prevalence of the ageing population is increasing, because of increased life expectancy, the prevalence of older people with diabetic kidney disease is likely to increase. diabetic kidney disease is associated with an increased risk of adverse outcomes and increased costs to healthcare systems. the management includes promotion of a healthy lifestyle and control of cardiovascular risk factors such as hyperglycaemia, hypertension and dyslipidaemia. older people are a heterogeneous group of people from a community-living fit and independent person to a fully dependent individual residing in a care home. therefore, management in this age group should be based on a patient’s functional level adopting tight metabolic control in the fit individual and relaxed targets in the frail person. however, despite the maximum available therapy, a significant number of patients with diabetic kidney disease still progress to renal failure and experience adverse cardiac outcomes. therefore, future research is required to explore methods of early detection of diabetic kidney disease and to investigate novel therapeutic interventions to further improve the outcomes.age-related metabolic and renal changes predispose older people to an increased risk of diabetes mellitus and diabetic kidney disease, respectively. as the prevalence of the ageing population is increasing, because of increased life expectancy, the prevalence of older people with diabetic kidney disease is likely to increase. diabetic kidney disease is associated with an increased risk of adverse outcomes and increased costs to healthcare systems. the management includes promotion of a healthy lifestyle and control of cardiovascular risk factors such as hyperglycaemia, hypertension and dyslipidaemia. older people are a heterogeneous group of people from a community-living fit and independent person to a fully dependent individual residing in a care home. therefore, management in this age group should be based on a patient’s functional level adopting tight metabolic control in the fit individual and relaxed targets in the frail person. however, despite the maximum available therapy, a significant number of patients with diabetic kidney disease still progress to renal failure and experience adverse cardiac outcomes. therefore, future research is required to explore methods of early detection of diabetic kidney disease and to investigate novel therapeutic interventions to further improve the outcomes. so-called "social distancing" and measures of hygiene have proven to be effective reactions to the threat of increasing numbers of covid- cases and fatalities. however, there is no such thing as a free lunch. as medical doctors, we know very well that the majority of our most effective treatment methods unfortunately have chance of provoking severe side effects. in every day practice, we are used to balanced and shared decision-making based on national or international guidelines on an individual level together with our patients and their families and caregivers. in the battle we are all fighting against covid , at the moment there is no balancing or shared decision-making at an individual level. rather, at the population level, within their national borders, countries all over the world aim to reduce contact among humans to prevent infection with covid- . this has a positive effect on protecting health, especially for the elderly and ill people. children, adolescents and their parents are usually at a much lower risk for severe illness, even if there have been rare deaths in this age range as well. political measures that aim to achieve social distancing hit their age groups particularly although the efficacy of school closures is of equivocal evidence [ ] . this calls for further reflection on the effects on their mental health. over the past few weeks, an estimated % [ ] or more of children and adolescents have faced the effects of school closures. in addition, most other social and out-of-home activities for children and adolescents have been canceled. they no longer enjoy positive interactions with their sport coaches, music teachers, friends and peers. children and their families have to share a restricted space at home with limited resources and have to change their daily life and routines to cope with numerous new challenges. children are supposed to get home schooling, supervised by parents. however, some parents are expected to work as much as possible at home office or, due to the nature of their job, are confronted with daycare problems. support and the help of grandparents and other family members fall away, as they should avoid contact. all family members struggle with their own anxieties in this situation and for many families, economic pressure further increases stress. when a family member dies, the child has to deal with their grief. quite often, a combination of challenges clusters in families with limited space, job loss, and other known risk factors such as mental illness/disabilities of family members or single parenting. together, all of this can erupt in interpersonal violence and there is a series of reports on increased domestic violence and increased child abuse during this first phase of the pandemic (an overview is given by fegert et al. [ ] ). in brief, children and adolescents are at home with their families, experience an increase in stress and a reduction in support and coping resources. as a result, on the spectrum from healthy-coping-struggling to unwell, many children can expect to suffer, though some will do better. as with most other stressors, resilience and coping are bound to play their role for most individuals. special attention is needed for those who were already struggling or unwell before home quarantine. anecdotally, in clinical practice, we see three emerging patterns. a first group of children seem to prosper. they are at home in a quieter environment; they thrive with the structure and support their parents provide; they enjoy online learning and they are not exposed to bullying nor find themselves socially excluded. a second group seems to be mildly adversely affected. their developmental opportunities are paused as they may have too few resources available for online education, are unable to interact with others to practice social skills and no longer have access to practice what they were learning in social/ emotional-treatment. the third group includes children and young people who find themselves in families with increasing negative interactions and who are deprived of the safe haven offered by their schools. to make matters worse, services and help may be temporarily less available. for those who are in need of professional help, the outreach of mental health services has been reduced. families avoid consultations due to fear of covid- . the activity of child protection services and currently existing programs of support or supervision by youth welfare agencies is reduced or interrupted. this is a result of re-organization of services, with provisional care (including re-assigning doctors and nurses not usually involved in critical care), (partial) closures of facilities to avoid the risk of infection and in some services illness among personnel. the lack of access to the support services can be particularly harmful for vulnerable children and/or families who experience increased stress. thus, school closures exacerbate inequities, disproportionately affecting already disadvantaged children [ ] . a small group of youth and children who were previously in residential centers are in a mental health crisis after they went back to their dysfunctional families. in inpatient treatment, infections among staff and/or patients can lead to isolation and separation of patients and sub-groups developing a cohort immunity. a first screening of patients via helplines may help to avoid infections; while in some places, strict rules to avoid infections with distancing and quarantine are abandoned to maintain the functioning of the clinical units. if inpatients have reduced access to their families due to hygiene restrictions, this makes it difficult to adhere to the un convention of children's rights. units should maintain their child patient's contact with their family as much as possible. how are we, as european child and adolescent psychiatrists (cap), supposed to deal with this situation? first, in our clinical practices, we need to continue to provide services for children and adolescents with mental health disorders. cap institutions should keep contact with patients who have special needs and those patients who are missing out on specialized education systems both to avoid disrupting current treatment programs and to offer support to caregivers. parents and patients should be informed not to stay away from private practices and hospitals when mental health care is needed. to avoid a concentration of the most severe cases in hospitals on wards with reduced staff and difficult or unsuitable care conditions, outpatient and inpatient facilities must be kept open as much as possible; they need to follow all the necessary protocols to prevent transmission of the virus. crisis interventions must be accessible at all times. for patients with new onset of child psychiatric disorders, appointments should be arranged and they should be directed to adequate care. digital communication with the patient's family should be used wherever possible to support parents on how to deal with the current challenges. europeans generally have smart phones but those in very poor families may not. they may have no opportunity for a safe, confidential space at home. support regarding how to address anxiety and stress in children is important (for information on these issues see, e.g., recommendations of escap [ ] ). in many places, there are adverse consequences for training and for the workforce. recruitment is not possible because of home working and the difficulty of ensuring equity of opportunity. this is compounded by staff being redeployed to care for covid- patients. cap is an understaffed discipline already. on the positive side, we see an acceleration in switching to online training and supervision, development of e-learning. there are newly emerging networks of international information exchange about the effects of corona on mental health and to share lessons learned. the further development of an international network of cap trainers as well as the development of courses on an international level and moocs may prove to be crucial to maintain training [ ] . after the crisis, it will be important to avoid delays in training caused by the crisis. there should be regulations that acknowledge training experiences in child and adolescent psychiatry and psychotherapy even though the normal functioning of training courses, personal supervision, etc., have been interrupted. in a broader scope, in many hospitals, we are sharing what we have learned about mental health advice with other health care professionals. this may well prove to have an additional long-term effect on the awareness of the importance of (child) mental health and on recruitment for future mental health care professionals. last but not least, mental health professionals should take precautions to safe-guard their own mental health; minded has recently provided front line staff in the nhs and care services with recommendations for management of mental health, whilst looking after others during the covid- crisis (https ://covid .minde d.org.uk); child and adolescent mental health care professionals, too, may well profit from such recommendations. turning to the role of cap in research, it is not an empty plea that more research is urgently needed on both the shortterm and the long-term effects on child mental health to better inform policy makers. even though numerous reviews on mental health effects of covid- are being published (just to name some examples: [ ] [ ] [ ] [ ] ), they are based on the existing literature that only partly mirrors the current situation. prospective assessment of the effect of covid- -related mental health effects in children and adolescents is needed. international collaborations in the eu seem key to both detect general as well as specific mechanisms at play in each culture and country. in addition, it is important to analyze the tele-psychiatric interventions to determine measures of quality control and ask patients, parents and therapists through questionnaires about the usefulness of online therapy to help maintain such services in the future. the question of data-protection and the use of user friendly, easy to handle systems are challenges that are not fully solved yet. however, based on the old medical ethical position that the health of the patients is the primary issue (aegroti salus suprema lex), many child and adolescent psychiatrists and psychologists and social workers have managed to stay in contact with their patients by new technical means. taken together, cap faces numerous challenges. however, to maintain emergency and regular treatments, training and research wherever possible must be a priority for all cap professionals. in the long term, child mental health is the basis for future adult mental health which is closely associated with general health and is, thus, related to productivity and well-being in our society. although measures that aim for "social distancing" are important to protect the health of our society, political decision makers have to keep in mind that it does not come without side effects and that children, adolescents and their families bear a major burden of these measures. in medicine, treatment decisions are never made on the potential benefit alone-the risk of side effects always has to be taken into account. likewise, in the current situation, risk-benefit analyses are urgently needed based on the effects of "social distancing" including importantly for children and adolescents school closures. although current knowledge about the risks is based on studies with limited comparability or on just emerging novel results, this information has to be taken into account. instead of "social distancing", measures that enable "physical distancing" with maintained "social connectedness" should be aimed. effective alternatives for school closures may be "physical distancing" measures such as to keep students in classrooms and to decrease the number of students per class and to increase space between students [ , ] . as a result of governments taking their own national measures, the return of border controls and the financial risks inherent to the covid- pandemic, this crisis carries the risk of reduced solidarity across europe. as is the case for all other international families, we, too, as the european cap-family, find ourselves physically separated. this should not stop us from trying to remain emotionally close. advocacy of european cap to policy makers from a mental health perspective should be based on the principle: first, do no harm (primum non nocere). school closure and management practices during coronavirus outbreaks including covid- : a rapid systematic review covid- educational disruption and response covid- pandemie: kinderschutz list systemrelevant considering inequalities in the school closure response to covid- dealing with children and adolescent mental health during the coronavirus pandemic training for child and adolescent psychiatry in the twenty-first century the psychological impact of quarantine and how to reduce it: rapid review of the evidence the outbreak of covid- coronavirus and its impact on global mental health mental health effects of school closures during covid- coronavirus disease (covid- ) and mental health for children and adolescents school practices to promote social distancing in k- schools: review of influenza pandemic policies and practices acknowledgements the authors of this editorial come from europe; the contents should be interpreted accordingly. authors include representatives/board members from the union of european medical specialists, section of child and adolescent psychiatry (uems-cap) and the european society of child and adolescent psychiatry (escap). the core author group consists of the first three authors (vc, pd and jf). vera clemens , · peter deschamps , · jörg m. fegert , · dimitris anagnostopoulos , · sue bailey , · maeve doyle , · stephan eliez , · anna sofie hansen , · johannes hebebrand , · manon hillegers , · brian jacobs , · andreas karwautz , · eniko kiss , · konstantinos kotsis , · hojka gregoric kumperscak , · milica pejovic-milovancevic , , · anne marie råberg christensen , · jean-philippe raynaud , · hannu westerinen , · piret visnapuu-bernadt , key: cord- - oc lisi authors: abbott, patricia a.; coenen, amy title: globalization and advances in information and communication technologies: the impact on nursing and health date: - - journal: nursing outlook doi: . /j.outlook. . . sha: doc_id: cord_uid: oc lisi globalization and information and communication technology (ict) continue to change us and the world we live in. nursing stands at an opportunity intersection where challenging global health issues, an international workforce shortage, and massive growth of ict combine to create a very unique space for nursing leadership and nursing intervention. learning from prior successes in the field can assist nurse leaders in planning and advancing strategies for global health using ict. attention to lessons learned will assist in combating the technological apartheid that is already present in many areas of the globe and will highlight opportunities for innovative applications in health. ict has opened new channels of communication, creating the beginnings of a global information society that will facilitate access to isolated areas where health needs are extreme and where nursing can contribute significantly to the achievement of “health for all.” the purpose of this article is to discuss the relationships between globalization, health, and ict, and to illuminate opportunities for nursing in this flattening and increasingly interconnected world. lenges, human rights, and consideration of local and cultural context. nursing leadership, creativity, advocacy, and experience are needed to provide stewardship for health ict growth and application in the face of a complex, interconnected, and increasingly globalized world. the term globalization describes the increased mobility of goods, services, labor, technology and capital throughout the world. most would agree that globalization has a much broader impact than just an economic impact; its impact is also political, technological, and cultural-strongly influenced by information and communication technology. globalization, whether we recognize it or not, touches all parts of our lives-both personal and professional; it changes the way our nations and communities work. globalization and health have been discussed by many experts who have noted influences on wellness that are both promising and potentially devastating. [ ] [ ] [ ] [ ] globalization in a positive sense has resulted in trade expansion, with an increase in living standards and improved social and economic status, particularly for women. sachs, a global economist known for his work in developing nations, repeatedly makes the important point that the health of a nation is directly tied to the wealth of a nation. wealth is enhanced by heightened competition, comparative advantage, economies of scale, and access to a greater range of products and services in globalized markets, all enabled by access to knowledge. asymmetries of information have been reduced in an era of globalized knowledge exchange, contributing to a reduction of isolation, an increase in life spans, and improved health. conversely, advances in globalization are blamed for some health problems, including an increased adoption of unhealthy western habits and lifestyle, resulting in increases in obesity and the increased prevalence of chronic disease. open borders and open access, hallmarks of globalization, have also resulted in faster transmission of infectious agents, the so-called "microbial hitchhikers." many societies find globalization and open information exchange threatening to current ideologies and social structure. others view the concept of globalization, particularly via ict, as a new age form of electronic colonialism, where existent cultures are bulldozed and assimilated. how does ict fit in this discussion of health and globalization? the world health organization (who) believes that ict holds great promise for improving health and health care around the world and is critical to achievement of the millennium development goals. the core beliefs that ict will contribute significantly to the reduction of poverty, improve the delivery of education and health care, and make government services more accessible are prominent in the world health report. the report, towards a safer future, continues to emphasize the importance of ict in relation to health: "today, the public health security of all countries depends on the capacity of each to act effectively and contribute to the security of all. the world is rapidly changing and nothing today moves faster than information. this makes the sharing of essential health information one of the most feasible routes to global public health security." a widely held view, both within the who and elsewhere, is that ict in health enables rapid and global access to new therapies, techniques, and knowledge resources, with the potential to forever change the health of nations. the role of ict in the severe acute respiratory syndrome (sars) crisis of is a prime example. during the first cases of sars in china in , the who initiated a digital virtual environment consisting of laboratories in countries connected via ict. using e-mail and a secure website, these collaborators shared outcomes, post-mortem tissue analysis, electron-microscope pictures of viruses, genetic sequences and other related materials in real-time to collaboratively identify and intervene in a markedly dangerous public health risk. other examples exist that point to the impact that ict has had on global health efforts, such as the academic model for the prevention and treatment of hiv/aids medical record system for africa (ampath-mrs), the partners in health electronic medical record in peru, the hiv electronic medical record system in haiti. efforts such as those mentioned above and scores of others, too extensive to enumerate, have made significant impacts in the health of large regions of the globe. however, it is important to realize that ict can never be viewed as a panacea or singular solution to the very multifaceted problem of worldwide health. the contributors to global health are very complex, rooted in societal structures, political agendas, and the presence of marked global poverty. solving one issue without addressing the others will result in the same outcome experienced by sisyphus; the summit is reached, only to have the boulder roll back down to the base. in particular, efforts to improve health without addressing the pressing problem of poverty will be unsustainable. poverty reduction as a precursor to improvements in health is reflected in the world health report: "hungry children easily acquire diseases, and easily die from the diseases they do acquire. dwellings without sanitation provide fertile environments for transmission of intestinal infections. hopeless life circumstances thrust young girls into prostitution with its attendant risks of violence and sexually transmitted diseases." productivity drops when the human capacity that fuels economic growth declines due to morbidity and mortality, and the high financial burden of disease in developing nations precludes economic advancement and health improvement efforts. the paradox is, of course, that declining health impedes the climb out of poverty while poverty contributes to declining health. could further enhancement of global ict for health care be a potential strategy for escaping this paradox? what are the realities and reasoned approaches for application of ict to impact the health of nations? what roles and opportunities for nursing leadership exist in regards to ict regardless of geographic location? in many instances, the idealism of ict potential and the reality of ict application are discordant. therefore, while there is acknowledged need for ict in the coordination and monitoring of treatment, surveillance, response, education, and communication in health care, in reality there are significant barriers in the application of ict that slow progress. these barriers are in no way restricted to the developing world. the united states and other more technologically advanced nations have their own sets of challenges. cost, misalignment of incentives, resistance, an unskilled workforce, concerns about impact on productivity, lack of standards and interoperability, and other issues contribute to a poor level of healthcare ict adoption in the industrialized world. the digital divide has resulted in large segments of low income and/or other underserved groups being excluded from online health resources. economic hardships and difficult tradeoff decisions in the us healthcare industry have further inhibited healthcare information technology growth. in developing nations, the problem of ict uptake is even further compounded. a lack of local expertise and decades of well-meaning but non-sustainable ict projects in the developing world have left a legacy of skepticism in their wake. systems built for westernized health care delivery often do not match the local context, resulting in a misalignment between need and technology. poverty and illiteracy in developing nations stand as major barriers to the adoption and sustainability of information technologies, and many believe it is difficult to make the case for ict when basic needs for survival are barely being met. the "e-health paradox," a term coined by liaw and humphries, refers to this seeming conundrum; populations that may have the most to gain from ict in health are those who are thwarted in their use due to barriers of untrained personnel, poor infrastructure, and lack of resources. issues such as these have fueled technological apartheid and continue to subvert the delivery of knowledge to areas of the globe that most desperately need it. are the current realities in global health ict all bad? actually, they are not. from adversity often come new ideas. new opportunities and avenues for access and innovation in the use of ict are emerging to improve health and facilitate the delivery of health care. the use of ict in health care in more industrialized nations such as the united states, the united kingdom, and australia continues to grow, albeit at modest rates, reaching a tipping point. as discussed earlier, there are many successful implementations of ict-enabled health communications and electronic health record systems in developing nations such as kenya, malawi, peru, rwanda, haiti, tanzania, and others as part of efforts like the open medical record system (open mrs). creative thinkers are already capitalizing upon widely available forms of ict (such as cellular telephony) to affect health. muhammad yunus, whose work in microloans in bangladesh was honored in with a nobel prize, is an excellent example of how the creative introduction of ict via simple cellular telephony into a low resource area could institute profound change. dr. yunus and the telecom company he founded were convinced that economic and social development should begin at the grassroots level. yunus believed that attacking poverty is essential to peace, that private enterprise is essential to reversing poverty, and that peace and poverty reduction are essential to health. yunus' microloans enabled destitute village women in bangladesh to purchase cell phones and become village phone operators (vpos). the women then sold telecommunication services on a per-call basis to neighbors. this has resulted in considerable wealth generation not only for the vpos, but for the farmers and village dwellers who are using this technology to access the outside world and improve their businesses. the vpos provide affordable rates to their neighbors, preventing residents from making (historically, in many locales) a -hour roundtrip to reach a telephone, which consequently impacted community productivity and increased community wealth. the vpos earned enough to invest in their children's health, nutrition, and education, and fund other business growth. the improvement in community wealth translated into improved community health, as funds became available for the drilling of wells for clean water and preventive health services. the vpo model has been rolled out through much of africa and is viewed by governments and development agencies such as the united nations, usaid (united states agency for international development), and the world bank as a sustainable development tool. wealth has impacted health, which is a welcomed consequence. the swell of cellular telephony has also expanded directly into the realm of health and health care in other ways, particularly as the use of short messaging service (sms)-otherwise known as text messaging-has grown in popularity as a form of communication. for example, "sexinfo," a sms-based health information service offered by the san francisco department of public health, is being used to educate and assist teens who have questions about sexual health. the centers for disease control and stanford university teamed up recently to hold a conference called "texting for health" where public health initiatives using sms were presented. south africa is using sms features in cellular telephony to issue reminders to patients and caregivers in hopes of increasing adherence with antiretroviral therapies. phones for health, a presidents emergency fund for aids relief (pepfar)-funded project, is also using mobile telephony to combat hiv/aids in sub-saharan africa. this project allows nurses and other health workers in the field to use a standard mobile phone handset to enter health data. the system uses cellular methods to relay the data to a central database, where it is immediately available to health authorities via the internet. the system also supports the delivery of health alerts and reminder messages to caregivers. each of these examples illustrates a movement using ict to enhance information distribution that empowers financial growth, health, and social betterment, in both developed and developing nations. the success of such initiatives opens the door to innovative global ict methods for enhancing education, public health monitoring and surveillance, and delivery and management of health. it also speaks to opportunities for those who stand at the frontline of global health efforts to consider new ways to reach and teach. where is the opportunity for nurses to make a difference in regards to health care in a digital world? when one considers that - % of all health care provided "in country" is delivered by non-physician providers and the accessibility of ict is accelerating, the opportunities for nurses and midwives are vast. as those who most often stand at the interface of the patient and the healthcare system, there is a growing awareness of the need for nursing leadership, nursing innovation, and the nursing voice in global health ict. a number of areas of development demonstrate how nursing has already embraced ict to harness its global potential and should illustrate potential areas for growth and further investigation. examples of success stories from a global perspective include: ( ) advances in education and collaborative learning, ( ) telenursing/ telehealth, ( ) movement toward electronic health records (ehrs), ( ) nursing knowledge management and knowledge generation. in consideration of the challenges and opportunities cited earlier, these examples may stimulate critical and creative thinking about how these established examples and methods may be extended and applied by the nursing community to address the e-health paradox. information and communication technology has influenced both traditional and non-traditional approaches to education and the development of the next generation of nursing leaders. distance education programs in nursing are exploding across the globe and are enabling outreach to geographically distributed individuals. the use of ict to elevate the educational level of nurses worldwide is a crucial area for expansion, investigation, and application, particularly as the nursing workforce crisis grows, global health declines, and medically underserved areas increase. considering the issues of nurse migration and nursing brain drain, ict may be an effective strategy to reduce some of the contributors to out-migration, such as isolation and lack of educational opportunity. methods such as ict for education to train rural providers in place can prove to be more cost effective and less disruptive to families, communities, and nations than out-migration to more developed countries. moreover, collaborative learning opportunities are enabled via ict, where geography becomes irrelevant. the opportunity for students and faculty to interact, share knowledge, discuss global health issues, and share cultural perspectives across nations affords students and faculty exposure to the world beyond them. such experiences can increase cultural competency, raising awareness of and appreciation for global health issues. although the promise in using ict to reach and teach is great, there is also a need for caution and careful consideration. as discussed earlier, the notion of western solutions as being universally appropriate is erroneous. understanding how information and knowledge is relevant to context and culture is essential, so as not to impose approaches or solutions that do not fit the learners' reality. approaches that seem appropriate for delivery in one environment may be offensive or totally unrealistic and unvalued in another, highlighting the need for local involvement, flexibility, and creativity. this is particularly apropos when considering the vast differences between industrialized and non-industrialized nations or in nations that are in conflict. nursing has taken the lead in several successful international collaborations involving education and collaborative learning. two examples of the use of distributed e-learning in industrialized and non-industrialized nations are provided as a stimulus for further study and application: international virtual nursing school (ivinurs) a central activity of ivinurs is the building of its digital repository and the development of associated e-learning support products, with the aim of providing quality, learning resources that can be shared on a global level by its partners, and used to enhance both e-learning and traditional instruction in their respective settings. this not-for-profit entity, registered in the united kingdom as a limited company with charitable status, is still in formative stages, and expects to make available studies of its impact in the near future. uganda is an example of using ict in the developing world for nursing education and scale-up. this public-private partnership plans to increase the basic education level of kenyan nurses up to the level of "registered" (diploma) from the current level of "enrolled" (certificate) within years. at present, % of the nursing workforce in kenya is comprised of "enrolled" nurses, whose level of education leaves them ill-prepared to handle the complex health needs of the kenyan population. the amref's "virtual nursing college" currently has nurses enrolled at computer-equipped training centers in provinces, including several refugee camps. the curriculum is delivered via ict and, in october of , the first class of icttrained kenyan nurses completed the program. while too early to discuss program outcomes, the fact that % of all nurses enrolled in this program are from rural areas speaks to a great potential for communities outside of urban centers. this model is planned to be extended to other african nations who are experiencing similar nursing crises. the amref program is also important because of an important but less publicized goal-that all nurses will be computer literate. this very unique and vital component leaves kenya ready to lead in the movement towards e-health in the developing world. this could accelerate the achievement of the who resolution wha . , an e-health strategy adopted by the fifty-eighth world health assembly in may that articulates the preparation of an ict-competent global health workforce. these brief examples, while using different methods and addressing different audiences of nurses, demonstrate the potential of ict within the nursing education realm. it also demonstrates the reach of it-enabled methods in rapidly digitizing developing nations-further illustrating an area of opportunity for expansion. considering the global workforce crises in nursing, these models are worth further consideration. telenursing is the use of technology to deliver nursing care and conduct nursing practice. telenursing is often used interchangeably with the term telemedicine or telehealth with the distinction implied that a nurse provides telenursing and a physician provides telemedicine. the use of the term telehealth may be more appropriate, as the success of this modality requires multiple partners, including the professionals delivering services, technical support personnel, and the client or patients themselves whose participation is essential to successful outcomes. telehealth, in all of its definitions and permutations, has made large strides in expanding healthcare services to underserved areas around the globe. in a recent study, nurses representing countries responded to a survey querying their telenursing competencies and skills. patients with chronic illnesses were those most often cared for using telenursing services. although most telenurses worked in hospitals, the settings varied widely, including traditional work places such as clinics to community-based settings such as schools and prisons. several countries have well-developed telenurse programs, including canada and new zealand. the trend towards expansion of this nursing specialty is expected to continue, particularly as ict continues to reach all areas of the globe and as the medically underserved areas of the world are illuminated. telehealth/telenursing in the traditional sense may conjure up visions of expensive computer workstations, call-centers, or a nurse in a chat room. while these visions are perfectly realistic in the developed world, they are quite unrealistic in many parts of the globe. however, with the growth of cellular telephony, particularly in africa, tremendous opportunities exist for nurses to creatively apply telehealth modalities to long-standing patient care issues. for example, elder and clarke cite the following examples for the potential use of cellular telephones and personal digital assistants (pdas) for telehealth in africa and asia: • automation of demographic surveillance activities such as those at the core of pioneering health care initiatives (e.g., the tanzanian essential health interventions project) • testing of the use of sms (short message service) reminders in the treatment of tuberculosis in cape town, south africa • delivery of continuing medical education and professional development via pda • delivery of time-sensitive alerts to patients and health care workers • maintenance of patient records for hiv-positive patients' lifelong drug treatments • management of specific health care initiatives such as the roll-out of antiretroviral therapy and tuberculosis treatment initiatives again, realizing the numbers of nurses who are in the frontline of primary care around the globe and in light of the massive growth of ict for health, tremendous opportunity awaits those who are primed to capitalize upon these factors. making the application of telehealth/telenursing successful in developing countries will require strong nursing partnerships and leadership, however. nurses are in a position to drive the development of science in this area, since many aspects of nursing care are naturally amenable to virtual delivery, especially in areas of assessment, patient teaching, decision support, and early identification of problems. globalization is driving the need to communicate and share healthcare data and information across national borders. many countries are focusing on interoperable electronic health record systems (ehrs) as a solution for sharing data and information among various sources (e.g., clinical information systems, personal health records, public health surveillance systems, and knowledge repositories). for ehrs to reach full potential, however, interoperability and connectivity to distributed data repositories is fundamental, particularly in light of distributed healthcare services, geographical challenges, and migrating populations. in a global sense however, there are vastly different levels of ehrs readiness and capacity for ehrs interoperability. in many places, ehrs are unknown yet the need for health data (in any fashion) is great. even the most remote of locales often have reporting requirements, either from ministries of health or donor agencies. accountability for receipt and utilization of goods and services, demonstration of outcome achievement, and measurement of milestones are resulting in increasing pressures on nurses, other providers, and administrators for improved information management and tracking. quick fixes or one-off solutions, characteristic of many health data tracking efforts, often result in unusable, non-interoperable, and unsustainable systems that are soon abandoned, threatening clinic viability and leaving service providers frustrated. efforts such as open mrs are gaining in popularity, due to its open source (free) and interoperable nature, and its well-established success in many clinical settings across the global south. open mrs is an example of an ehrs system, built to agreed-upon standards that enable interoperability, data exchange, and the ability to use it in many different settings in many different locales. while this is an open source and freely available system, there are no documented examples of nursing use-which is puzzling when one considers the number of nurses who are responsible for clinic operations around the globe. it is important to note that, even in developed nations, nursing involvement in ehrs specification and development is disappointingly low. such lack of ehrs involvement by nursing in both developed and developing nations makes it that much easier for nursing data to remain invisible and inconsequential to determination of health outcomes. healthcare, both nationally and internationally, is a product of teams (including the patients), and such teams are reliant upon the sharing of information and knowledge. standards facilitate sharing of data, information and knowledge and are a foundational underpinning for system interoperability. those who do not participate in standards development, implementation, and use face the prospect of exclusion in ehrs. as is, the contributions that nurses make to patient outcomes and the achievement of larger health care goals are frequently invisible in ehrs because the standards that exist to represent nursing practice in automated systems are either underused or excluded. nurse-sensitive measures are frequently omitted from ehrs for a multitude of reasons, and they will continue to be, unless the case is made for inclusion. as nurses accelerate their utilization of and leadership in ict-based efforts such as the ehrs, the chance to share perspectives, experiences, and best practices via standardized and exchangeable data must not be missed. nursing experience, leadership, and the nursing voice are needed. interoperability from a global perspective requires international standards in many dimensions such as messaging, security, language, ethical information use, ict management, and other areas-all of which impact nursing and ehrs. again, nursing involvement is critical. one challenge is that there are multiple standardssetting agencies and, most likely, always will be due to the complexity of stakeholders, which increases the difficulty of nursing participation, particularly in consideration of the dearth of qualified standards-literate nurses. while there are many standards organizations around the globe, the international standards organization (iso) and health level (hl ) are of the major standards-setting organizations where nursing is represented (albeit in small numbers), and it must continue to be so. an example of successful nursing involvement and leadership in global standards work is the icnp®. initiated in by the international council of nurses (icn), icnp® is defined as a unified nursing language system to represent nursing diagnoses, interventions, and outcomes. the vision of icnp® is to be an integral part of the global information infrastructure informing health care practice and policy to improve patient care worldwide. through standardizing the clinical terminology nurses use to describe their practice, icnp® can improve nursing practice and contribute to the advancement of nursing science. the icn also recently partnered with the international medical informatics association-nursing informatics and the international nursing informatics community to establish an international standard through iso. this standard, integration of a reference terminology model for nursing, provides a framework which can be used to map concepts across different terminologies, thereby increasing communication and comparability of data across languages and countries. this iso standard is currently under routine review and is expected to contribute to ongoing harmonization across multiple international standards, giving structure to nursing data in global ehrs efforts. this work is critical to understanding the full processes of and contributors to health care. analysis of data that does not include nursesensitive measures, nursing interventions, and nursing contributions to outcomes is deficient, incomplete, and prone to spuriousness. the international telecommunication union (itu) is another organization involved in standards development that has direct bearing on nursing practice, particularly as related to communications protocols used in disaster relief and community-based services in the aftermath. as the leading united nations agency for information and communication technologies, itu plays a prominent role in the development and deployment of global ict standards. for example, in the aftermath of the indian ocean tsunami in , itu played a major role in pushing for standards for public warnings (called cap or common alerting protocol), disaster management, prevention, and relief. there is a great need for the nursing perspective in these concerns, particularly since a great deal of the care in disaster relief efforts is provided by teams heavily infused with nursing personnel. nurses, as first responders and those often managing the ongoing health needs of a community after disaster teams have left, have a vested interest in ict that supports information and workflow needs. unfortunately, nursing is often absent from the development and deployment of such standards and are frequently left to deal with suboptimal systems. nursing leadership is critical to break the chicken and the egg cycle that comes from unstructured, nonstandardized, and invisible nursing data in the rapidly digitizing world. without comprehensive, rigorous and accessible digital nursing data from large healthcare datasets, nursing practice remains largely invisible, and invisible nursing contributions lead to false assumptions of low nursing contribution to health and health outcomes. in reality, much has not changed since florence nightingale wrote in her book notes on a hospital, "in attempting to arrive at the truth, i have applied everywhere for information, but in scarcely an instance have i been able to obtain hospital records fit for any purposes of comparison. if they could be obtained . . . they would show subscribers how their money was being spent, what amount of good was really being done with it, or whether the money was not doing mischief rather than good . . ." in , years later, we are still struggling to determine the amount of good that is being provided, largely because the nursing data that is foundational to a full understanding of nursing contributions to outcomes, both good and bad, is still unfit and unavailable for comparison. the opportunities and critical need for nursing leadership are growing exponentially. information itself is becoming a major commodity in health; there are multiple stakeholders interested in access to and sharing of data and information. access to reservoirs of experiential knowledge and collections of explicit information allows for the development of new knowledge based on identified needs, to refine knowledge that already exists, to avoid duplication of effort, to increase alignment with local circumstances, and enhance the creation of actionable knowledge. the value to nursing of such collections of knowledge and experience becomes quite obvious, particularly when considered in the global context and in the face of asymmetries of information. effken and abbott have identified ict solutions for knowledge management in nursing, including the creation and participation in communities of practice (cops). cops trace their roots back to constructivism where the control of learning shifts from the instructor to the learner. wenger discusses ict supported cops specifically, stating "every group that shares interest on a website is called a community today, but communities of practice are a specific kind of community. they are focused on a domain of knowledge and over time accumulate expertise in this domain. they develop their shared practice by interacting around problems, solutions, and insights, and building a common store of knowledge." from a global nursing perspective, especially in light of the scarcity of nursing resources, reusable and accessible nursing knowledge empowered by ict is a powerful tool for the profession. one such ict-supported cop is the global alliance for nursing & midwifery, different countries. the alliance has served as a learning platform, a library, and a knowledge exchange forum for global nurses to exchange best practices, participate in open continuing education, and manage knowledge. the global alliance is unique in that it runs over very low-bandwidth, standard telephone service to allow participation by those in areas without full internet connectivity. participation from low-resource areas is surprisingly robust. other cops exist for nursing, and growth in this area is expected. for example, hara and hew in studying an online cop for critical care nurses in the pacific rim found that an e-cop helped not only to reinforce the identity of the practice of critical care nursing among participants, but that it also served as an important avenue for information and knowledge exchange within the context of everyday work. these authors believe that: "communities of practice can be described as groups of people who are informally bound together by shared expertise and a passion for joint enterprise. they can be viewed as informal networks that support professional practitioners to develop a shared meaning and engage in knowledge building among members. the theoretical construct of communities of practice is grounded in an anthropological perspective that studies how adults learn through everyday social practices rather than focusing on environments that are intentionally designed to support learning." information and communication technology has also stimulated the growth of other approaches to knowledge generation and nursing research. for example, icn recently initiated an electronic international nursing partnership database project. the goal of this project is to document and share ongoing and new international partnerships, as a tool to encourage similar initiatives and aid in planning new ventures. rather than relying on the traditional literature sources for networking and proposal development, this database can provide researchers and others with pre-publication information about existing projects in process. similar to the cop concept, the icn shared database allows the sharing of partnership experiences and results to maximize efficiency and effectiveness. the icn has also developed a portal called the international nursing network to facilitate the exchange of ideas, experience, and expertise for the nursing profession crossing a variety of areas from advanced practice nursing to disaster preparedness. this open access portal serves as a mechanism to encourage global nursing interaction. the management and generation of new nursing and healthcare knowledge is deepened and advanced as new evidence, new perspectives, and new discoveries are shared among global nurses and midwives. information and communication technology provides an opportunity to facilitate participation and to establish partnerships using technology that connects those otherwise not connected. enabling these connections will promote approaches not yet realized to managing, sharing, and generating nursing knowledge. the ultimate benefactors include not only the patients and communities that we serve, but the profession of nursing itself. some scholars suggest that there is a leadership void in nursing, particularly in the global south, where the needs are the greatest. leadership for strategic use of ict and informatics in nursing, and strategic partnerships to support mutual enhancement of ict is an important strategy for the promotion of global health. entrepreneurial opportunities exist for those proactive and creative thinkers who stand ready to capitalize upon them. nurses cannot wait for ict to bring answers to the problems faced in today's world; rather, they need to be engaged in problem-solving activities, testing and evaluating solutions to global health issues using ict. the pace at which ict seeps into health care is only expected to increase, and reasoned action by the nursing community is imperative. the nursing informatics arena has provided avenues for nurses to serve as leaders, including multiple roles in nursing and through participation in professional organizations. however, nursing informatics, like nursing in general, stands at the edge of a workforce crisis that threatens nursing participation in the rapidly progressing world of ict. nursing as a profession cannot leave the progress needed in the face of accelerated global ict solely in the hands of nurse informaticians. informatics practice is quickly becoming part of the expected competency of every nurse and, therefore, is becoming not only a responsibility of every nurse, but as an opportunity for every nurse. the absence of the nursing voice and nursing leadership as global e-health explodes is foreboding. in addition to leadership, strong partnerships are essential to advancing health globally. these partnerships should not only include corporate and philanthropic organizations, but partnerships within the healthcare team as well. interdisciplinary work is critically important and the major contributions that nurses make to global health must be acknowledged and supported at levels much higher than they currently are. similar to the efforts undertaken by the robert wood johnson foundation's commitment to nursing, it would seem appropriate that major foundations and funding agencies would support the investigation and growth of ict as a strategy to support frontline nursing care, since nurses are such a vital source for the delivery of health services worldwide. it is also important to emphasize that the agenda for using ict to advance global health is in no way limited to experts in informatics. nursing expertise in practice, education, administration, research, and policy are all required to advance this agenda. the nursing profession, as partners in improving global health care, has much to contribute, particularly in this new interconnected and flattened world. entrepreneurial opportunities for nurses who are interested in global health and who understand and are intrigued by digital innovation abound. the authors have highlighted examples of first steps that the nursing community has already taken in applying ict to health and healthcare. following the example of amref in uganda and the online training of nursescould this model not be built upon and expanded to the global nursing workforce? could nurses, long known for their crucial role in patient education, develop ict-supported solutions to reach patients, their families and caregivers-regardless of geographic location? can we use ict to provide lifelines to isolated nurses, midwives and others who are serving their communities? can we deploy simple ict solutions to combat the problems of collecting critical individual and population health data in remote locations? considering that there are more mobile telephones in use in china today than there are people in the united states, what innovative mobile methods could be developed to deliver health messages, answer questions, or collect data? what role might social networking (e.g., wikis, blogs, virtual communities) play in nursing of the future? what shall be the legacy of the current generation of nursing leaders in this rapidly digitizing world? to answer these questions, we need nurses who have what henry ford classified as those with an "infinite capacity to not know what can't be done." nursing has a long-standing history of advocacy, innovation, and education. the growth of ict in the health and healthcare sector should be looked at as an opportunity for nursing to use a new medium to meet the mission of our profession, not as something to be approached with trepidation and fear. as globalization expands, nursing has the opportunity to step forward and harness the power of ict to serve the greater good. while it is often difficult to make the case for ict in areas where running water and electricity are considered a luxury, access to information must be viewed as a basic tenet of a developing nation, with efforts to increase ict and decrease poverty as complementary, not competitive activities. as nurses, we have the opportunity to renovate and innovate, as we shepherd developments in a way that promotes health for all. at the nursing outlook website: www.nursingoutlook.org. references . friedman t. the world is flat: a brief history of the twenty-first century health in an age of globalization globalization definition nursing leadership: international council of nursing globalisation and public health is globalization dangerous to our health? globalization and health: targets met, new needs the globalization of public health. i. threats and opportunities the end of poverty: economic possibilities for our time globalization and its discontents globalization, information and communication technologies, and the prospect of a 'global village': promises of inclusion or electronic colonization? working together for health. world health organization towards a safer future. world health organization implementing electronic medical record systems in developing countries health, wealth, and the chinese oedipus free internet access, the digital divide, and health information slowing the growth of u.s. health care expenditures: what are the options? the commonwealth fund report rural ehealth paradox: it's not just geography! grameen foundation microloan pioneer and his bank win nobel peace prize texting for health distance education: the solution for nursing and midwifery in africa? geneva: international council of nurses pageidϭ & searchstrϭe% dlearning. accessed on kenya graduates first nurse definitions of telenursing, telepresence report of the - international telenursing survey national initiative for telehealth framework of guidelines. nifte website, national initiative for telehealth professional standards for telenursing practice past, present and future: experiences and lessons from telehealth projects international competencies for telenursing. published by: international council of nurses international classification of nursing practice version . , geneva: published by: international council of nurses iso: integration of a reference terminology model for nursing nursing language-terminology models for nurses available at: http://my.ibpinitiative. org/displayknowledge.aspx?cϭ c - b - e- e- a &fϭf f - c- d - adc-ac d b f& iϭ b e a-c - f-a -ccf cf acc the nursing role in health it-enabled care management in rural, frontier, and other underserved populations agency for health care quality and research a study of technologies for communities of practice available at: my.ibpinitiative.org/public/ganm/. accessed on a case study of a longstanding online community of practice involving critical care and advanced practice nurses available at poverty and development: pulling forces and the challenges for nursing in africa the robert wood johnson foundation anthology: to improve health and health care volume viii key: cord- - y z qso authors: henry, caitlin title: palliative space-time: expanding and contracting geographies of us health care date: - - journal: soc sci med doi: . /j.socscimed. . sha: doc_id: cord_uid: y z qso two important changes are happening in health care in the us. as hospitals close in high numbers, the geographies of health care services are changing. also, the ageing of the population brings about new and complex care needs. these are not discrete trends, as ageing impacts the who, what, and where of care needs, and hospital closures remakes the geographies of where people overall access care. developed out of research on the impacts of hospital restructuring on workers, patients, and communities, this paper aims to understand how health care financing, care needs for the ageing, and new geographies of health services are intertwined. to do so, i look back to s policy changes to medicare, the federal health insurance program for the elderly and disabled. in , congress made two important changes to medicare. the program began covering hospice services, constituting an expansion of care, and the government drastically changed the way it reimburses providers, effectively a contraction of the program. i trace the impacts of these changes over the next decades through analysis of media coverage and secondary research on hospital budgets. drawing on the concept of palliative space-time, i identify a contradictory logic of death at the center of this expansion and contraction of the health care system. this death logic works to destabilize an already uneven geography of health service. yet, this crisis has the potential for more just geographies of health and care. like many global north countries, the us population over is growing, as baby boomers age and americans live longer lives, forcing attention to how societies can support thriving in old age. individuals, governments, families, and institutions are considering new ways of meeting the care needs of elderly people throughout the last decades of their lives, including age-friendly cities, new collective living arrangements, new institutional forms of care, and an increased focus on home care especially (poo ) . as activist ai-jen poo ( , ) explains, 'people getting older is not a crisis; it's a blessing. we're living longer; the question is how we should live.' the demographic shift comes with a cultural shift around the end-of-life. this is visible through the growing popularity of the death positive movement and caitlin doughty's 'as a mortician' series (the order of the good death n.d.), as well as countless books and podcasts exploring the meanings and practicalities of dying. furthermore, covid- 's disproportionate impact on elderly and people vulnerable due to health conditions, or the strains of systemic oppression, has heightened this conversation. people are asking what a 'good death' could be in a socio-economic system that is threatening to many lives and devalues entire demographics (beech ; fraser et al. ). simultaneously, the health care service landscape has changed dramatically since . hospitals have closed across the country, transforming health care labour markets, how and where people access health care services, and the role of health facilities in communities and the built environment (buchmueller, jacobson, and wold ; colliver ; henry ; alexander ) . overall, hospitals are concentrating within and to wealthier urban and suburban centers, meaning both rural and some urban populations are quite far from a hospital. an excellent collaboration on the impacts of facility closures between the milwaukee journal sentinel and pittsburgh post-gazette on the impacts of facility closures found that 'nearly two-thirds of the roughly hospitals opened since are in wealthier, mostly suburban areas' while the number of urban hospitals has been nearly halved since (thomas ) . rural and disadvantaged communities are greatly impacted and left uncertain what health services will replace the shuttered facility (tribble ) . hospitals are closing for multiple reasons. their role in the health system is changing, with more care shifting away from hospitals and towards outpatient and home care (landers batra, betts, and davis ) . more importantly, hospitals are increasingly financially unstable and unsustainable institutions (goldsmith and bajner ; lovelace jr ) . just as aging populations are not exclusive to the us, hospitals are unstable across the west. canada and the uk are also downsizing hospital systems, even while wait times for care are high or increasing and aging populations are requiring more chronic care (howlett and morrow ; ewbank, thompson, and mckenna ) . every country's health system is unique, but trends in financial stress, care deficits, and inequalities are strikingly consistent across the west. closures raise questions about the built environment when the health care landscape changes because of the large size of hospital properties, the myriad services they house, and their historic role in urban development (henry ; day ) . this is not to be romantic regarding hospitals but to highlight the importance of hospitals in the social reproduction of individuals, communities, and the health care system (stevens ) . it means thinking beyond the impacts of a hospital closure on mortality rates (e.g., joynt et al. ) to consider health and health spaces more holistically. this article posits that these two changes are not discrete, as health care is undergoing dramatic spatial and financial changes in the us. thus, the driving question of this article is: what does the convergence of these two simultaneous trends in health care -the remaking of the health service landscape through hospital closures and the growing number of older people needing chronic and eventually end of life care -mean for the wellbeing of the entire health care system? how relational are these two trends? for answers, i turned to medicare and medicaid, the government-provided health insurance for, respectively, people over and low-income people. specifically, i examined the legislative history of medicare to j o u r n a l p r e -p r o o f better understand the role of these programs in hospital financing. in the early s, both programs underwent their biggest changes since implementation, as congress passed the tax equity and fiscal responsibility act of (tefra) and the social security amendments of (ssa). this legislation made hospice care a covered service for the first time, and altered the fee structure for reimbursing health care providers. these two moments help explain the current transformations in us health care delivery. the closing of hospitals -the backbone of the health care system -and the ageing of the population are two intertwined trends, tied together through medicare's financial structure. these policies of the s are contradictory. while the hospice benefit expanded coverage, the new payment scheme reduced financial stability. the and changes to medicare constituted an expansion and a contraction of medicare and, arguably, the health care system. together, they enacted a contradictory logic that is pervading the current health crises. more specifically, two different approaches to death -a care-full death for individuals accessed through hospice and an abandonment (or the dying) of the health care system via financial destabilization. in turn, these legislative changes, while not the only factor, have helped facilitate the transformation in the health care landscape that is unfolding today. to make sense of these legislative moves, i turn to feminist care ethics and eric cazdyn's ( ) concept of 'palliative time' -a state of existence that foregoes cure and marches towards, but does not always reach, death. i argue that with these structural changes to medicare, death permeates the entire health care system but in different ways. the dying of a health system has radical potential to destroy the system and create something new. in sum, this article contributes to historicizing understandings of the current j o u r n a l p r e -p r o o f transformations in us health care needs and services, adding nuance to understandings of the shape and impacts of hospital closures, care needs, and demographic shifts. this article draws on research from a broader project on the process and impacts of remaking of the hospital landscape in the us. i situate hospital closures and changing needs of an aging population in the historical context of health care funding. i use a textual analysis of media coverage in the s from four major newspapers -wall street journal, new york times, washington post, and the los angeles times -to trace debates about and impacts of these legislative changes. i chose these newspapers because of their wide readership, differing perspectives, and depth of coverage. through lexisnexis, i searched for articles discussing medicare and either hospice or prospective payment from to , generating over articles. i analyzed the articles in two ways. first, i used them to assemble a timeline of events. second, i analyzed them for how different writers and actors characterized the needs -both financial and care -of medicare and its relationship to the health system more broadly. i paired this news analysis with a review of secondary literature (primarily from health economics and public health) focusing on studies done since on the impacts of the prospective payment system on hospital financing and the use and cost effectiveness of hospice. in the next section, i turn to feminist care ethics and eric cazdyn's concept of palliative time, which i will later use to understand the implications of these legislative changes. building on these literatures, i propose the concept of palliative space-time (pst) as a useful tool for understanding the contemporary state of health systems. then, after outlining the two changes made in and , i trace legacies of these changes in the decades since. finally, i apply the idea of palliative space-time to these contradictory j o u r n a l p r e -p r o o f changes, to reveal a death-focused logic at work in us health care today and consider what alternative possibilities exist. i focus primarily on changes made to medicare, the federal program providing health insurance to the elderly, as well as some people with disabilities. when relevant, i mention medicaid, the joint state and federal program providing health insurance to the poor. while these are different programs, they are hardly discrete. policy decisions around one often affect the other, and for patients, these programs sometimes work in tandem to ensure access to care (e.g., medicaid, rather than medicare, covers stays in nursing homes). in the already dead, eric cazdyn ( ) draws on his experiences managing chronic leukaemia to analyse medicine's increasing focus on maintenance over cure. this approach prioritizes important life-maintaining care, cazdyn argues, over lifesaving cures. he describes patients as stuck in palliative time: a time of persistent sickness, hanging on near death. he invokes palliative care, which is comfort care most often delivered when one is near death, to argue that people become trapped in the end-of-life care phase. importantly, this new temporality also describes a political economic condition: the maintenance of a sick and sickening system. cazdyn pairs his critique of medicine with reflections on the impacts of globalization, arguing that globalized capitalism is a broken system, working well for the few and harming the many, that keeps a world lurching along, always near but never reaching death. he draws an analogy between economics and medicine that forces consideration of medicine's approach to chronic care in the political j o u r n a l p r e -p r o o f economic context of the health care system, as palliative time is a descriptor for patients as well as a global economic system. palliative time is not simply a temporal label. it is also an analytical tool that highlights the paradox at the center of the health care system: a near-death sphere of possibility, as cazdyn calls it, referring to the possibility of something new and more just coming out of deadly and also frail system. on the one hand, being stuck in the palliative means forgoing cure. no longer searching for cures, the focus shifts to maintenance. people are expected to live with chronic illnesses both social and medical rather than searching for the end of those illnesses, be they though cure or death. medicine resists death, viewing it as a failure rather than a part of life. for cazdyn, living with sickness means living, but always near death. on the other hand, palliative and hospice care is an ideal practice of care. it is attentive to needs of both individuals and communities, treating death with respect, reverence, and care. it foregrounds the nuances that nursing brings to health care, rather than the colder, more clinical approach of medicine. hospice faces death directly, without losing complexity of human experiences and approaches to death. in death, hospice patients and their loved ones often access the best care they have ever received. thus, palliative time captures a paradox in health care related to care and death, simultaneously holding two different, contradictory philosophies towards the end of life. the paradox describes a deadly system that also promotes, at times and in certain places, very care-full experiences of dying. these contradictory approaches to death offer different ways forward -one that maintains the deadly status quo and another, more progressive way that embraces death and dying as a meaningful part of life that deserves more attention. caring is more about a transformative ethos than an ethical application". care is an ethicopolitical approach to living committed to transforming unjust social organizations of life. it presents a different epistemology of death, life, and care. importantly, the act of care is an inherently spatial matter. as mitchell, marston, and katz ( , ) explain, subjects are constituted both 'through time and in space'. this constitution is a care-full and social reproductive process, as 'how we live in space' is how we maintain and reproduce ourselves and communities ( , ) . massey's ( , - ) explanation of space is helpful, arguing that space is a 'sphere of possibility' always in process. taken together, space is a sphere of making, caring, reproducing, and creating new. thus, a palliative temporality is also spatial; it can be called palliative space-time (pst). as an ethic of care is both an indictment of present inequalities and a call for a future in which people thrive and are cared for through the entire life course, pst similarly has this dual temporality. by centering possibility, palliative space-time is a tool for evaluating unequal access to the conditions for thriving, as well as offering a different way forward. it focuses attention on ways to better value care and body work, new intergenerational living arrangements, more accessible designs in the built environment, and different forms of institutional care. it also requires attention and correctives to oppressions that foster premature death and means some people are not allowed to thrive or even reach old age. each of these changes center an ethic of care in approaching space-making and design. pst is, therefore, an analytic tool that foregrounds care, death, and futurity in analyses of health systems. it is a descriptor of the workings and implications of actions, systems, policies, and relations. it holds care and death at the centre of the analysis, in relation, tandem, and opposite to each other. thus, pst could be used to understand the implications and workings of a health care system in financial dire straits, as i will show here. or, one could use the concept to consider other aspects of globalised capitalism; after all, ahmed ( , no page) reminds us that 'racial capitalism is a health system'. as a description of a state of existence, pst is a tool for shedding light on the unevenness of experiences and access to care, and the contradictions that have been built into the health system as it exists now. with the care-full principles of the palliative at its heart, pst centers a commitment to j o u r n a l p r e -p r o o f doing things differently in recognition of the failings of the status quo. this article explores legislation that has helped create those contradictions and fostered the increased unevenness. i employ pst as a descriptor of the impacts of this legislation, and a way to think through the near-death sphere of possibility of accessing health care under these conditions throughout the life course. applying a lens of pst reveals a complex relationship between care and death and decline at work at multiple scales. the qualities of pst are apparent at the national scale, shaping health care systems and access to care for the entire population through changes to the literal spaces that house provisions. death and care operate in contradictory ways at the scale of the community, as hospitals -community anchors -close or shift meaning and role in regions, cities, and rural areas. finally, pst describes the differential access to care individuals experience in life and in death. pst is useful for understanding the implications of those two legislative changes of the early s: the callous palliative state of the health care system, with the care-full service of hospice. while more money is invested in death care, the simultaneous restructuring of medicare financing destabilizes an entire health care system. as a solution, cazdyn ( , ) explains that "reclaiming our own deaths, not in a suicidal way, but in terms of our emotional and political consciousness regarding death and dying, therefore is tied to the reclaiming of utopia". facing death as an important part of life that needs care-full attention, systemically, can pave the way for a more just health system. in sum, the health care system has shifted its orientation towards space and time, and this shift is rooted in a new approach to the life course and death. in tracing the impacts of these two changes in the rest of this article, i will show how these possible futures are j o u r n a l p r e -p r o o f animated by a dual logic of death. the legacies of and reveal the health care system, both in its care-full and carelessness, working in palliative space-time. expanding medicare: the two legislative changes i examine here are contradictory. one expanded the services medicare recipients had a right to receive, while the other was a change aimed at reigning in an out of control entitlement. the first change, in , involved hospice care. hospice provides comfort care to the terminally ill, generally wherever the person calls home, be that a house, a nursing home, or a hospital bed (nhpco n.d.) . modern hospice began in the uk in the late s, through the work of physician dame cicely saunders, a nurse-turned-doctor who opened the first modern hospice, st christopher's, in london in (clark ). in the s, american nurse florence wald trained with saunders, and established the first hospice in the us in branford, ct in , providing both home hospice and inpatient care (adams ) . over this same time, other hospice programs, largely volunteer-driven, began to appear across the country (buck ; freudenheim ) . hospice is a philosophy of care that foregrounds the patient's goals and values. saunders and other hospice pioneers' goal was for medicine and health care to approach death differently, as a part of life, not as a failure of a body or the medical profession, and to understanding it holistically, involving mind, body, community, and family, and attending to a patient's 'total pain' (clark ; livne ) . in hospice, the patient is more than themselves, because 'although death [is] a solidary event, hospice advocates insisted it must not be lonely' (abel , ) . (buck ; rich c; a) . in , congress made coverage permanent and expanded hospice funding. the inclusion of hospice allowed medicare patients to access expanded services and benefits, such as prescription drugs not usually covered under the program. though most major insurance companies had some sort of hospice provision by (torrens ) , the inclusion of hospice in medicare was a significant step in standardizing and legitimizing it as a way of care for those at the end of life (quinn ). this enacted a new ethic of care by establishing hospice as an insurable service. contracting medicare: j o u r n a l p r e -p r o o f the second legislative change of the early s constituted a contraction of the services, justified by the reagan administration claiming that medicare could be bankrupt by . when created in , medicare needed buy-in from physicians and hospitals in order to succeed. partly to win support from a hostile medical establishment, the program's fee structure paid well. as starr explained, the medical profession quickly learned ' [medicare] was a bonanza' ( , ) . the federal government also 'agreed to rules for calculating [reimbursement] costs that were extremely favorable to the hospital industry ' ( , ) . for its first years, medicare reimbursed providers retrospectively for the actual cost of care according to a test of 'reasonable cost', meaning medicare and medicaid paid hospitals very well (guterman and dobson ; stevens and stevens , ) . welfare programs have always first served the worthy poor, a population seen by state and society as worthy of assistance, compared to other populations deemed lazy or otherwise unsympathetic, generally according to racialized and gendered norms (garland ; piven and cloward ) . central to this categorizing, piven and cloward explain, is welfare's role in encouraging people into the workforce as the market demands through denials or granting of benefits, plus the role of employer-provided health insurance (thomasson ) . medicare and medicaid are major parts of the welfare state apparatus. they provide patients with vital access to care and funnel financial support to providers through reimbursements. they also operate like other welfare programs: providing (selective) support while disciplining recipients. developed out of decades-long struggles over national health coverage, legislators designed these programs for uneven access (starr ; stevens and stevens ; quadagno ) . by the s, 'the aged could be presumed both needy and deserving, and the contributory nature of social security gave the entire program legitimacy' (starr , ) . for medicare and medicaid, this includes certain poor j o u r n a l p r e -p r o o f people, people who qualify as disabled, and retired people who already made their societal contributions through a lifetime of work or raising children/future workers. therefore, while many welfare programs regulate people into the workforce, medicare is a benefit for after the workforce. it is a universal program, granted after a lifetime of labor, with age as the only condition for qualifying, and no conditions for kicking one off the rolls. medicare and medicaid in the early s. over this first years of the programs, health care costs grew not only from inflation, but at a rate beyond inflation (pear b; schwartz ; waldholz ; merry and schorr ) . some of this expense came from improvements in health care which includes more expensive procedures and equipment. some of this increased expense, claimed health care economists and legislators, also came from a fee structure that did not encourage cost controls (for example, see coverage by rich ) . as stevens and stevens ( , ) argue, while medicare grew into a widely accepted program, medicaid remained unable 'to escape the debilitating effect of its welfare parentage'. the introduction of prospective payments for medicare came after reagan's administration had already cut billions from america's suite of welfare programs. while medicare was and remains wildly popular (norton, dijulio, and brodie ) , the financial strain on the program made it into a potentially untenable luxury and justified it as a problem that needed solving. as part of tefra, congress implemented some 'interim changes to the medicare reimbursement system' (guterman and dobson ) (pear a ). this was a decidedly different purpose for medicare payments. the new payment scheme created set amounts to reimburse providers for every health care product (services, inpatient stays, and physical products). rather than billing for the cost incurred, the pps set per-patient and per-day billing rates as well as a scheme for the reimbursement price for each service or product. rates are set through calculations based on a standardized payment, the area's wage index, and a diagnosis-related group (drg) classification system, plus variations for urban and rural contexts and regional differences. guterman and dobson ( , ) identify an important characteristic of pps: "each hospital keeps, or loses, the difference between the payment rate and its cost for that unit of care." in other words, the program expected providers to pick up any slack. this is the same payment structure medicare uses today. from the beginning, these legislative programs contradicted each other, constituting an expansion and contraction in care. the months the federal government spent working out the details of the hospice benefits implementation reveal the challenges of expanding care access in an era overall hostile to public services. the hospice benefit proved contentious immediately after its passage. in the preparations for the hospice benefit, a dispute ensued j o u r n a l p r e -p r o o f between the members of congress who sponsored the bill and congressional budget office (cbo) over the rates at which providers were to be reimbursed. when passing the bill, the house ways and means committee set a payment ceiling of $ per patient (rich c stockman, head of the omb, argued that claims that hospice would save money were misleading, as the program would actually cost the government hundreds of millions of dollars in its pilot phase (rich a) , something that would be deeply unpopular given the panic around health care costs (pear b) . lawmakers argued that lowering the rate was a violation of the agreement reached in the initial legislation and would cripple the program (rich c; b) . ultimately, while hhs did set a lower rate than what lawmakers initially wanted, the final payout cap was much closer to the original figure through a series of compromises and amendments. these early months of the program demonstrate not only that the s laws were contradictory, but also reveal the complex financial role of hospice and the trouble with the dominant ways of valuing health care. when health care is seen first and foremost as (too) expensive, the necessity of it takes a back seat. from these rocky early days emerged a landmark program as 'tefra has remained the most central piece of us hospice legislation' (livne , ) , fueling the expansion and standardization of hospice services. after congress made the hospice benefit permanent in j o u r n a l p r e -p r o o f , funding was expanded in (nhpco n.d.) . by the mid s when clinton was attempting to reform health care, hospice was taken as an integral part of health care (nhpco n.d.) . since tefra, hospice has become a more standardized set of services with clear criteria for when patients can or should access the care (buck ; livne ) . for example, carney et al ( ) found that, with the implementation of the medicare hospice benefit, patients received more care from registered nurses, less care from volunteers, and patients accessed care when they were sicker, which they credited to the six-month provision. the standardization-via-medicare took time. uptake of certification was slow in the early years of the program, with only % of eligible hospices becoming certified (buck , s ) . at tefra's passage, hundreds of hospices were operating in the us but few received medicare benefits; for facilities to qualify, 'major reorganization will be necessary to conform with the centralized administration required by the congressional act' (los angeles times ). as the washington post reported, interviewing john j. mahoney, president of the national hospice organization, "some hospices say medicare rates are too low to justify going through the difficult certification process. others, he said are too small to justify the costs and trouble of certification," and others were waiting to see if the program would exist after (rich ; see also buck ) . over the s, and especially after the program became permanent part of medicare in , more programs opted to become medicare certified and funding increased (davis ; gilinsky ) . the numbers of hospices both in general and medicare-certified have grown at a rate of - % each year since tefra (livne , - ) . in , hospice became reimbursable under medicaid as well, and now, all states j o u r n a l p r e -p r o o f include the benefit (kaiser family foundation ). by the mid s, most commercial health insurance plans included coverage for hospice care (buck , s ) . annually, government spending on the medicare hospice benefit has grown - % annually (medpac , ) . as of , medicare has become the largest payer in the country, paying for % of hospice patient care days. hospice was attractive to lawmakers in for its potential to save medicare money (bayer ; greenberg ) . cost effectiveness was based on patients staying at home, in (powers et al. ; zuckerman, stearns, and sheingold ; medpac ) . the fact of savings may be less important than the belief that hospice care is cost effective. as livne's ( ) study of hospice in california shows, the belief in thrifty hospice agencies providing low-cost care is a powerful force shaping how providers care for patients and families. regardless of cost savings, hospice is of growing importance as the population ages. the blunt truth is that a lot of people will die in old age over the next few decades. this is, therefore, an important social and cultural moment in both ageing and the end stages of the j o u r n a l p r e -p r o o f life course. as a significant portion of the population ages and encounters the end stages of life, new questions emerge with urgency: what care is needed at the end of life? how can the system ensure access to such care? as hospice has grown over the past years, more spaces have become palliative. homes take on new caring roles, and new spaces specifically designated for palliative care open (brown ; turner et al. ) . legislative and financial support for hospice care opened up new possibilities spatially, temporally, politically and economically for relationships to death that foreground care and attention to death. the prospective payment system reflects the other side of the palliative space-time paradox. following , the system expanded over the next two decades to cover physician fees as well as skilled nursing and long-term care facilities (the washington post ; wodchis, fries, and hirth ) . nearly every state uses a prospective payment system for medicaid reimbursements. recall that financial instability is the major driver behind hospital closures. early on, pps impacted hospital finances (phillips ) . in , the first full year of the program, % of all hospitals saw a loss of revenue, while % of for-profit hospitals saw revenues increase (guterman and dobson ) . this means that public and non-profit hospitals, which generally serve deprived communities, felt the impacts of pps more. facilities serving vulnerable populations became more vulnerable. additionally, with pps hospitals found it challenging 'to pass along the costs of free care to the medically indigent' (mclafferty (mclafferty , . by its own accounting, the federal government states that pps was partially responsible for many rural hospital closures in the mid- s (cbo ). as well, facilities serving a high proportion of medicare patients were more vulnerable to closure over the j o u r n a l p r e -p r o o f s (williams, hadley, and pettengill ) . pps is not the sole cause of closures, but it is an essential structural factor in their instability. most hospitals operate on break even budgets. approximately one third operate on negative profit margins (aha ). hospitals are dependent on a fee structure that does not ensure financial stability. a hospital's revenue comes predominantly from insurance reimbursements. but hospitals serve patients with a mix of insurance -private plans, government-provided insurance, and no coverage. hospitals depend on having a payer mix that earns enough revenue to stay open and provide care to everyone. privately insured patients are key to this, as their plans pay well. a closer look at the breakdown of payments is instructive. over % of all care hospitals provide is covered by medicare and medicaid association (aha ). while private insurers generally overpay at a rate of %, medicare and medicaid generally underpay by %, sometimes more (cunningham et al. ) . medicare patients are both desirable (they have reliable insurance) and undesirable (medicare does not reimburse well enough). medicare is thus integral to a facility's survival but also risky. then there are the patients who are uninsured and cannot pay for the care they receive. though hospitals try (aggressively) to recoup those costs, they are left to eat the expenses. it is commonly assumed that hospitals cost shift shortfalls from other patients on to private insurers (frakt ) . facilities facing financial shortfalls actually do not rely on cost shifting, but instead cut staffing and operating costs per patient (hadley et al. ; white and wu ) . as white and wu ( , ) explain, "over the long run, medicare price cuts do not result in hospitals shifting costs to other payers or more profitable services; they instead constrain overall operations and resource use". without enough insurance reimbursements, and especially from private j o u r n a l p r e -p r o o f insurance, hospitals may not stay open. in addition, not only is a hospital's very existence at risk, but also, quality of care and labor conditions directly bear the brunt of the payment scheme's impacts of a facility's struggle to balance the budget. spaces of care thus change or disappear. pps has implications for access to care that extend beyond hospitals, shaping access to care in multiple ways. for example, long-term care facilities often limit the number of medicare and medicaid patients they will accept, reserving more beds for people who can pay better through private and supplemental insurance (mor et al. ; smith et al. ). medicaid, which uses a pps, is the largest funder of long-term care, creating another fragility in the system providing care for older people and those with chronic health needs. echoing cazdyn, the health care system is stuck in palliative space-time. applying the lens of pst shows a geography of pps impacts as deadly to systems and spaces of care. in the wake of the legislative changes, the health care system is permeated by death and possibility. hospice care is expanding, increasing access to comfort care for dying people and their families. the role of hospitals in the health care system is shifting, from improvements in care, pressures from insurance companies, and increased financial precarity. rather than stabilize medicare, the pps structure maintains the status quo of uneven and precarious access to services and an increasingly uneven geography of services. this continued with the affordable care act, implemented in : importantly, the program j o u r n a l p r e -p r o o f slowed the rise of health care costs and gave people greater access to health care through insurance regulations and expansions to medicaid. yet while hospitals saw net gains, especially in states that expanded medicaid access, the kaiser family foundation (cunningham et al. ) has reported that hospitals expect changes to medicaid policy and the high volume of medicaid payments to actually offset some of those gains. increased reliance on a system that reimburses poorly is not a prescription for good financial health. instead, applying a pst lens, the system itself is dying but never allowed to die and not healthy enough to ensure sufficient care for all. this deterioration takes on additional meaning as demographics change. with more people aging, more people will both qualify for medicare and need more care. this means a growing number of medicare patients accessing chronic and hospice care. the demographic and political economic contexts together bring connections between generations, spaces of care, and health care provisions into sharp relief. while hospice is not causing the closure of hospitals, these systems are far from separate, tied together through medicare. this interconnection is apparent when considering intergenerationality in the health care system. the s have afterlives, creating a special relationship between the care of a select population and the care needs of the entire population. a logic of death and dying connect these two concerns. because of the importance of medicare to the financial wellbeing of hospitals, an entire system becomes dependent on a health care system for a single age group. there is an intergenerational dependence (society, health care facilities that everyone uses) on one group of people (seniors) because of their access to a specific program (medicare). a program for some supports an entire system for all; medicare has become the program keeping spaces of health care open and precarious. as the us j o u r n a l p r e -p r o o f population ages, the number of people over -and beneficiaries of medicare -is expected to reach million by (kaiser family foundation ). the financial implications of pps and any changes to it will become even more important. while access to health care in the us has never been universally guaranteed, the death that pervades the health care system destabilizes the entire system. pst helps name the important expansion of care but also the structures that destabilize care for all, holding them together in the same frame. importantly, while the remaking of health care spaces threatens everyone's accesseven those with private insurance -it is most acutely felt by those on the margins: people unable to drive great distances to the next nearest hospital, people without cars whose neighborhoods lack transit, people who suffer heart attacks and wait an hour for the ambulance to take them to the hospital an hour away, people already suffering in an antifeminist, racist, and anti-poor system. the precarity of the system means premature death and logics of pst permeate the health care system. pps makes life precarious until a person reaches , when they might have better access to good care at the end of life. the life course, though, unfolds in myriad ways, and people access and need chronic and death care at all ages. depending on a single demographic's program to support an entire system has significant implications beyond that demographic, especially when the general population that more care everywhere in an often-brutal socio-political economic system. the reach of pps is far, with the legislative changes of and working in tandem. as livne ( , ) hospitals are incentivized to send people home as soon as possible, but also face steep penalties from medicare for quick readmissions (henry ) . in contrast, hospices are also paid prospectively, but done so per diem, meaning a longer stay earns more money (increasing self-sufficiency). in other words, "the hospice ethic therefore converges with [hospice's] financial interests, hospital's financial interests, and the overall effort to reduce spending on end-of-life care" ( , ), as the last year is typically the most expensive of a person's life. death care is rewarded, while care at other times in life is rolled back and made precarious or harder to access. pps, as understood through pst, is a program that no longer cures ills in the health system, but maintains a fragile and sick system, with communities losing hospitals -anchors of services, economic activity, and built environment. dying is, therefore, at the center of this remaking of health system, spatially, over the life course, and through death itself. instability in the system through financial precarity leads to instability of health care spaces and geographies; this in turn leads to greater instability in the health care system and loss of access to care, as what replaces hospitals is not always clear. importantly, the palliative is political, and placing death at the center of these politics is a contradictory move towards something new. the system is failing people, and as cazdyn argues, addressing the manifestations of palliative space-time head on in a radical way means forcing a change; this might be risky, but the system is already deadly. the care needs and changing approaches to those specific needs are a twin transformation occurring in the health care system. hospice and its increasing importance over the past years, represents the emancipatory and utopian side of palliative space-time -a reclaiming of death and life in a health system that centers death. alternatives and the potential for action are abundant. medicare recipients will grow to become a significant voting block in coming decades, as will the very politically engaged generation z. the sandwich generation of adults taking care of aging parents and children of their own have a stake building a robust and stable health system to support their own care pressures. increasing discontent and attention is turning to hospital closures, with communities protesting such closures, for example, the outrage over the closure of a hospital in brooklyn that culminated in its closure, but also legislation mandating better consideration of community and public health needs before allowing hospitals to shut (frost ) . as well, increased media coverage of the impacts of closures is increasing, for example, with kaiser health news's series on the a small kansas town coping with the loss of their hospital (tribble ) . furthermore, fed up with the growing care deficit and expense of the health system, public opinion towards universal health care has shifted dramatically in the past ten years. each of these trends have great potential to create more just health systems, making it all the more important to understand the implications of a health program's financial structure. in many ways, these changes to the health care arm of the welfare state do not represent a new process. the hospital system has undergone a series of downsizings since hitting its peak after the passage of the hill-burton act in , the federal funding program that poured money into building more hospitals across the country in the post-war era. geographer sara mclafferty ( ) demonstrated that the wave of hospital closures from the late s to the mid s most impacted smaller facilities serving communities of lower socio-economic status. uneven access is always filtered through difference. this is apparent in the impacts deindustrialization had on public long-term care (winant ) . as well, closures of the s- s must be understood in the context of integration, or the period when nearly all black hospitals closed (sanford iii ) . legacies and patterns of uneven access to care and good health persist. given this history, what is special about the changes in the early s? the changes of and signify a movement towards a systematic death drive, towards operating in palliative space-time for the health care system. it is a systemic shift in the system towards a form of care with necropolitical goals -focused on not just making live, letting die, and making die at the level of individual and population, but also at the health care system. palliative space-time names not only a withdrawal of services or an increase of stress on caregivers. it describes a shaking of the entire system through closures of physical locations of care, but with the potential to remake the system out of the ruins of closed facilities. for what replaces a hospital could be something wholly different and just. systems and practices of care change, evolve, improve. this article ultimately is arguing for critically centering the impacts of such changes. what happens in a hospital's wake? where do people receive care? where do workers work? what does the loss of tax dollars, a space of care, and an anchor of community mean for workers, communities, economies, politics, health care systems and provisioning? and how does a payment structure reveal what people actually value? centering these questions might open up a way towards 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expanding and contracting geographies of us health care key: cord- - uk y authors: fischer, benedikt title: some notes on the use, concept and socio-political framing of ‘stigma’ focusing on an opioid-related public health crisis date: - - journal: subst abuse treat prev policy doi: . /s - - - sha: doc_id: cord_uid: uk y canada has been home to a longstanding public health crisis related to opioids, including an extensive mortality and morbidity toll in the face of substantive intervention gaps. recently ( ), two extensive reports from preeminent federal authorities – the chief public health officer and the mental health commission of canada – have been tabled with detailed, core focus on the phenomenon of ‘stigma’ and its impacts on substance/opioid use and harms. the reports present extensive descriptions of the nature and effects, as well as a multitude of prescriptions for remedial measures and actions to “stop the cycle of stigma”. closer reading of the documents, however, suggests substantial conceptual and empirical limitations in the characterization of the – multi-faceted and challenging – nature and workings of ‘stigma’ as a socio-political, structural or individual process or force, specifically as it applies to and negatively affects substance use and related outcomes, primarily the wellbeing of substance users. concretely, it is unclear how the remedial actions proposed will materially alleviate stigma process and impacts, especially given apparent gaps in the issues examined, including essential strategies – for example, reform of drug user criminalization as a fundamental element and driver of structural stigma - for action that directly relate to the jurisdictions and privileged mandates of the report sources themselves as health and policy leaders. the commentary provides some concrete while subjective notes and observations on the dynamics of stigma as applies to and framed for substance/opioid use, as well as strategies and measures necessary to both tangibly address the material health and wellbeing of substance users, and related forces of stigma, in the distinct context of the opioid crisis in canada. in at a recent peak-point of opioid mortalitytwo prominent, federal-level reports, ) the chief public health officer's (cpho) report on the 'state of public health in canada' [ ] , ) the mental health commission of canada's (mhcc) report on 'stigma and the opioid crisis' [ ] were tabled and widely disseminated. both these elaborate reports centrally focus on the role of 'stigma' for chronic disease and public health, and specifically 'substance use' and the 'opioid crisis' (the mhcc report with such exclusive focus, the cpho report within a broader focus on stigma and public health). 'stigma', at its foundations, is a sociological concept, crucially furthered by the canadianborn sociologist erving goffman [ , ] . essentially, it indicates the ascription of negative attributes or assumptions (or 'stereotypes' or 'mark of disgrace') on a person because of certain properties or behaviours outside their control, and consequential loss in social status, opportunity, and care or support (including possible 'discrimination') [ ] . luoma provides some essential conceptual and practical characteristics of stigma. stigma is produced and reproduced in many ways, including common 'cultural practices' of everyday life, and highly resistant to change. it can be helpful to distinguish between 'organizational' or structural level, and individual-level processes of stigma, both of which include (structural or individual, respectively) 'prejudice' and 'discrimination' as ways of enactment of stigma. for example, organizational/structural stigma, through related power processes, involves (intentional or un-intentional) policies or organizational rules, restrictions or opportunity barriers towards stigmatized group; whereas individual-level stigma can be divided into public (e.g., the individual reactions or judgments) about a stigmatized group (e.g., 'addicts') as well as 'self-stigma' (e.g., the internalization of negative selfvalue and status, and consequential self-preclusion from key opportunities (e.g., treatment) or negative outcomes experienced by the stigmatized individual themselves. a large variety of different strategies and approaches to reduce stigma have been identified and tried, with however limited demonstrated effects on reducing stigma [ ] . 'stigma' has been given distinct (while limited, e.g., when compared to mental health) attention in the psychoactive substance use realm, in part also related to the conflicting underlying social concepts or explanations (e.g., crime versus moral failure versus disease models) of 'addiction', and consequential implications for the social identities, status and interventions geared at the user [ ] . luomo notes that research on stigma in the addiction realm is in its "infancy", and that even less is known on "how to reduce stigma in this area." [ ] two pre-eminent 'anti-stigma' manifests both above-mentioned reports ascribe fundamental and sweeping cause-effect agency, as well as necessary remedial prescriptions to the phenomenon of 'stigma' as applied to the current public health crisis of substance/ opioid use in canada. for example, the cpho's report lays out in elaborate detail [ ] ; pp. how 'stigma' creates a fundamental "us versus them" between substance users and society, resulting not only in "significant economic costs, barriers to housing, employment, health care, productivity loss", functions as the root of "discrimination", wrongfully blames substance users for "poor willpower", and projects them to be "dangerous and reckless" and implies them to be not suffering from "real illness". beyond, stigma is listed as a driving factor of decreased service use, concealment of substance use, and health-harming coping behaviours (e.g., isolation, needle sharing), poorer health and quality-of-life (qol), limited treatment uptake and poorer outcomes for substance users. based on remedies prescribed for the stigma "cycle [to be] effectively stopped" and for "resisting the impacts of stigma" it is emphasized that required action need to occur on many (e.g., individual, institutional, population) levels, yet concretely by changing "biased and outdated language", "strengthening resilience" (e.g., through education), and devising "cultural competence" interventions for health care providers towards the development of "awareness, knowledge and attitudes". all the while it is then categorically acknowledged in the report that "it is difficult to know 'what works', in what context, to address stigma and discrimination" (p. ). similarly, the mhcc's report [ ] including a related review paper from one of the authors as integrated elementary content material [ ] -purports "broad agreement […that…] stigma surrounding opioid use is both significant and consequential" and has acted "as a barrier to reframe the opioid crisis as a public health issue", concretely as it "affects how we conceptualize, frame and prioritize [the opioid] crisis." stigma is furthermore stated to lead to "hiding and creates barriers to helpseeking, [… and that it] contributes to ongoing system mistrust and avoidance of services […and…] results in poorer quality care and response". for principal remedies, these campaign documents thenspecifically also as actions geared towards "health leaders" -prescribe "comprehensive stigma reduction and intervention strategies for frontline providers", "address[ing] the ethical dilemmas experienced by … front-line providers regarding high-recidivism clients and the emergency-relief measures (e.g., narcan) that may increase riskbehaviors"; and "increas[ing] the use of non-stigmatising language and establish[ing] best practice guidelines for opioid-related terminology and language"; ensuring "stigma-informed … prevention and policies efforts"; and removal of "organizational and policy-related barriers … to a full range of care interventions and services". yet here also, it is then acknowledged that "the evidence base supporting anti-stigma interventions in this [opioid] area is thin, and first requires a "more robust body of evidence". in related media release-statements, the cpho publicly called on "health leaders to tackle stigma [and] that we are all responsible for stopping it" [ ] , and the mhcc's ceo declares that "naming stigma as a public health crisis is brave, bold and necessary." [ ] one could be left with the distinct impressions, based on the above documents and statements, that the opioid crisis and its grave health and social toll in canada are primarily a product of forces of 'stigma', and that implementing the suggested remedies will reliably guide and bring about much awaited, tangible improvement and solutions. while 'stigma' is a certainly present phenomenon and social dynamic in the substance use realm, and adversely affects substance users' lives, behaviors and care in a multitude of ways, the above observations and remedies appear to be problematically narrow if not simplistic at key ends, while selective and featuring essential gaps in key elements and elaborationsespecially also when considering their originating sources. these impressions sit uneasily, and warrant some basic while subjective consideration and comments as per the following brief summaries of main illustrative examples: ) an (if not the) essential root driver and determinant of 'stigmatization', or the enactment of a fundamentally divisive 'us versus them' disposition for psychoactive substance usersfor example, opioid users in the specific context of the opioid crisis, but beyond involving other illicit substances in other contexts --is the fact that such use is categorically defined as a (criminally) illegal. this is so the case in canada specifically per definition of the controlled drugs and substance act (cdsa). arguably, there is no more powerful and impactful social tool to create, and project stigma on a structural level, and its direct and indirect adverse consequences, than through criminalizing a specific behavior and the people such criminalization identifies and targets [ ] . the criminal law, by definition, non-negotiably defines and enshrines most fundamental and shared social norms and values, and identifies actions and behaviors that violate and harm the social body of common rules which are then prescribed punishment as the state's most powerful form of power [ ] . the criminal law, therefore constitutes the authoritative, statesanctioned basis and seal of stigma in the context of a law-based society: for primary examples 'murder', 'treason' or 'assault' carry irrevocable, heavy, official 'stigma' for the law-breaking act, and those who commit it. moreover, the criminal law, or the process of crminalization, defines socially harmful and shunned actions, both by official and formal definition and its every-day enactment (e.g., enforcement); additionally, criminalization serves as the ultimately legitimate reference or justification for certain behaviorsor their 'actors'to be differentiated, excluded, or penalized from many realms of life. beyond, there is extensive scientific evidence on how 'criminalization' adversely affects substance use-related risks, harms and help seeking or service access [ ] [ ] [ ] . yet, nowhere do either report centrally name this quintessential link, or provide explicit recommendations that the 'criminalization' of drug use as a root driver of 'stigma' consequences ought to be materially corrected for the "cycle of stigma" to be slowed or stopped. this is particularly surprising since both reports come from leading federal government (cpho) or arms' length (mhcc) entities located at the very jurisdictional level of the cdsa as federal law in canada. both entities would be in a preeminent position to recognize, and emphasize for the explicit criminalization of substance (opioid) use as a primary, fundamental foundation of stigma that requires revision in order for the desired 'stigma reduction' to occur. ) similarly, there are other concrete, major intervention and policy actionsor gaps, rathertowards opioid-related public health measures along the lines of barriers and obstacles mentioned in theory that, for long, have been resisted by the very anti-stigma campaign protagonists. tangibly, federal government authorities, for considerable time, have refused to formally call a 'public health emergency' (under the emergencies act in canada) in response to the opioid crisis that would have allowed considerably more flexible and substantive measures to address and reduce related health risks and adverse outcomes, including the massive overdose mortality toll [ , ] . related, federal authorities have long resisted the implementation of broadbased, systematic provisions and measures for comprehensive 'safer opioid' distribution programming towards better protecting the numerous 'at-risk' opioid users from increasing exposure to highly toxic/ potent, illicit opioid supply and elevated risk for overdose and death [ ] [ ] [ ] . both types of measures reflect and mimic standard interventions applied and enacted elsewhere (e.g., for vaccinations for influenza, or acutely extensive transmission control measures covid- etc. [ ] ). on this basis, seemingly, preeminent health leaders emphasizing the exceptional burden from and need to "end the stigma cycle" themselves appear to be hindered or hesitant in their own efforts by 'stigma-related policy barriers' with substantial room for change towards more determined, concrete action. to present a questionably one-directional or simplistic perspective on the mechanics and nature of 'stigma'. while the reports' analyses suggest multiple 'pathways' or 'layers' of stigma, they essentially appear to suggest that 'stigma' is an exclusively negative force in functioning and outcomes, and brings on extensive harm in whatever it touches or affects; therefore, any available measures ought to be deployed for it to be 'purged' for its major, consequential harms to be reduced in desirable ways for general benefit. but the dynamics and workings of 'stigma', if considered more fulsomely, are much more complex, or multidimensional. for example, while surely there should not be genuine intent to negatively label, or categorically stereotype, drug users as 'bad persons', there are many behaviorsin the social realities of daily life, health, or substance usethat are widely recognized and agreed as factually unhealthy and undesirable, and therefore feature legitimate reason (e.g., for the benefit of interventions) to be negatively labelled. for example, 'drinking and driving', smoking in front of children, sharing injection paraphernalia, or stealing are generally agreed-upon risky or harmful behaviors which are for education or prevention messaging or deterrence purposesnegatively labelled and so conveyed for arguably good reason [ , ] . it cannot be in anyone's (and especially not prominent health leaders') real interest to suggest correction of these behaviors to positive, or even neutral status or messaging in the interest of all-encomassing 'stigma reduction'. rather, the real, while presumably more complex challenge for a meaningful addressing of stigma appears to be, as far as possible, to disassociate concrete, while undesirable or shunned behaviors and their negative labels from the general identity of those individuals or human beings who engage in or are associated with them, or least better consider and contextualize their real-life contexts, but not have their social or health or other existential opportunities categorically labelled or negatively burdened by them [ , ] . this separation of value attributions is not an easy task, also given that negative behaviors do not exist without people associated with them, and one that will likely never be perfectly possible; however, to imply or invoke a functioning social world in which everything and anything will be free of negative labelsi.e., without any negative association or labelsis neither meaningfully possible nor workable. ) specifically in the realm of the opioid crisis and its distinct evolution, there have been other, powerful forces of social 'labelling' or associations at work that may be (perhaps somewhat clumsily) referred to as 'false' or 'reverse stigma' (i.e., suggesting misguided positive signals or properties on behaviors where the opposite, or at least active prudence or caution would have been warranted); these can be assumed to have led to at least as much, but likely far more, opioid-harms in the population as the genuine (adverse) 'stigma' drivers and effects laid out in the reports. as a key example, an essential causal driver of the opioid crisis, specifically as it unfolded in north america, has included the widespread, excessive medical availability, prescription and usage of potent opioid medications starting in the early s. the vast increases in general population-wide opioid use, initially under the premise of improved population-wide pain care and featuring new -supposedly effective and side effect-free -opioid medications (e.g., oxycodone) aggressively promoted by pharmaceutical companies and facilitated by skewed prescription guidelines, insufficient regulation and prescriber practices alike, pushed large sub-populations into hazardous trajectories of opioid use, with many resulting in misuse, dependence or overdose deaths [ ] [ ] [ ] . later opioid formulationsincorrectlywere claimed to be 'abuse-deterrent' or 'tamper-resistant', and therefore safe from harm [ , ] . all this related to government-licensed and -approved drugs, and occurred under the knowing eye of government monitoring and regulatory control. for (too) long, key government and regulatory authorities provided no relevant policy responses, and then did 'too little too late', to stop the detrimental dynamics of the opioid crisis and its massive population health harms unfolding in slow-motion [ ] . as much as negative 'stigma' may push some opioid users into riskier behaviors or contribute to help or service access barriers and inferior care quality, as much did misleadingly, or simply false systemic positive social messages, images and pervasive assumptions about opioid medications and their alleged benefits, and related harmful (e.g., over-prescribing) practices endorsed or tolerated by key authorities contribute to the present opioid public health crisis. (notably, one of the reports considered points out that users of 'prescription opioids' "also" experienced negative stigmatization, making users feel "addicted … as much as a heroin addict"implying a needed differentiation in stigma attribution between users of 'medical' and 'non-medical' drugs) ( [ ] , p. ). these above factors ought to be taken into account especially when examining 'stigma' as one form of a social process influencing behaviors and adverse outcomes, whereas these are complemented by other social processes leading to and contributing to the same problem's formation and consequences. ) there is a sizeable, recent body of scientific literature e.g., specifically including systematic reviews from the past decadedevoted to stigma, substance use and related interventions. surprisingly, little of these evidence-based insights appear to be considered in comprehensive depth in either of the two documents. for example, while respective reviews find ample evidence for a common presence of negative attitudes and beliefs towards substance users among health professionals or policy representatives, and correspondingly ample accounts of such experiences and consequences among substance users themselves, other key elements of empirical knowledge on or understanding of 'stigma', and especially effective counter-actions appear to be much more restricted [ ] [ ] [ ] . concretely, there is a lack of essential construct, measurement and definitional clarity and consistency, and a dearth of rigorous (e.g., longitudinal) studies and other research on stigma [ , ] ; there overall are few consistent findings on the relationship between stigma and substance use, and few studies have evaluated actual consequences of subjective 'stigma' impressions [ ] ; and evidence on effective stigma-reducing interventions is considered limited [ ] . crapanzano et al. ( ) report the notable finding in their (medical student) study sample that these believed that stigma beliefs among health care professionals were indeed common, but that their own beliefs and care practices would not be influenced by these [ ] . there appears to be good reason for some sensible reflection or restraint to be applied on the above stigmafighting campaign and action front, specifically as generously projected on the 'opioid crisis' in canada. there is little doubt that ample stigmatizing forces and experiences exist and crucially work against the health and wellbeing of substance users in many ways, and should be tackled and alleviated. to which extent this can be most effectively achieved mostly by 'language adjustments', 'resilience strengthening' or similar efforts suggested, everyone may consider and guess for themselves also since current scientific knowledge does not provide much conceptual clarity or substantive evidence what such efforts tangible mean or can accomplish in material reality. the dynamics and effects of stigma for substance use, and both meaningful and realistic ways towards addressing and working to resolve these, however, can be assumed to be much more complex and challenging than what the above-cited two documents and their -rather narrow, if not simplistic -accounts suggest. they may be so described, since they present only limited insights on the (e.g., structural, social and individual) causes or drivers of stigma for substance use, and possible promising and effective remedies for material and sustained change in the lives of those concerned (i.e., substance users). these factors require, and deserve, deeper and better examination and analysis for realistic contributions and improvements for the important stigma-related causes and issues at handespecially from the leading and privileged authorities from which have put forward these reports. first and foremost, the quintessential causal role of the criminalization of illicit substance use (and thereby its users) for the pervasive production of structural stigma needs to feature prominent recognition, and related calls for change in such a campaign if sincerely committed to effective and material stigma reduction. there appear, however, a couple of other latent risks or adverse effects associated with this kind of 'en passant'kind of 'anti-stigma' presentation and campaigning that avoids to name core causes and elements. one is that it can be dangerously seductive as a self-righteous, or serving platform on which now 'stigma' is staged as a convenient, general or principal 'scapegoat' for the opioid crisis, and its ongoing massive and persistent harms. calling out, rejecting and fighting 'stigma' as a socially shared villainous forceakin, for example, to n. christie's 'suitable enemy' concept for illicit drugs [ ]is somewhat similar to promoting 'motherhood and apple-pie' (or supporting justice, equality, and peace for all), while rather limited in applied value or impact if mainly remaining at rhetorical or symbolic levels, and not realistically translated into necessary material action or change at the causal foundations. the other is that such social campaigns may (too easily) serve as a distraction from those tangible or structural actions or measures urgently required to improve and protect the existential real-life conditions, and elementary health and wellbeing (including basic, daily survival through effective, comprehensive overdose prevention services) of the many at-risk opioid (or all substance) users. the current, long-lasting fight against the opioid public health crisis will not be won by campaigns against stigma in itself. rather, fundamental drug law and policy reform, i.e. purging the intent criminalization (and related material stigmatization) of drug use/possession as a 'criminal act', and consequentially defining 'the user' as a criminal being with all adverse consequencesincluding fundamentally negative stigmathat entails is a (the) foremost action priority for this end [ ] . much of this, if materially enacted, will provide and bring fundamentally 'de-stigmatizing' effects for substance users in many crucial (direct and indirect) ways. no such measures, however, are clearly laid out in the report documents mentioned, and thus form quintessential gaps towards substantive and effective anti-stigma efforts in this realm. concretely, after > , opioid-related deaths in merely a decade, canada yet in lacks essential elements of a comprehensive, consistent and committed 'public health emergency' strategy, and essential public health interventions, including reliable, national 'safer opioid distribution' provisions, for at-risk opioid users. it is when these urgent, material remedy needs and action gaps are effectively addressed by the health and policy leaders in charge, we should devote resources to an improved, in-depth understanding and effective addressing of what may be the remaining 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international phenomenon the stigmatization of problem drug users: a narrative literature review substance use related stigma: what we know and the way forward stigma among health professionals towards patients with substance use disorders and its consequences for healthcare delivery: systematic review the effectiveness of interventions for reducing stigma related to substance use disorders: a systematic review reducing stigma towards substance users through an educational intervention: harder than it looks a quiet revolution: drug decriminalisation policies in practice across the globe. united kingdom: release -drugs, the law & human rights publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations not applicable.author's contributions bf was the sole contributor for conceptualizing, developing and drafting the submitted manuscript. the author read and approved the final manuscript. dr. fischer acknowledges research support from the endowed hugh green foundation chair in addiction research, faculty of medical and health sciences, university of auckland; he furthermore reports topic-related research grants and contract funding from public only (e.g., public funding, government agencies) sources.availability of data and materials not applicable. ethics approval and consent to participate not applicable. not applicable. the author declares no competing interests. key: cord- -ea au c authors: gostin, lawrence o; debartolo, mary c; friedman, eric a title: the international health regulations years on: the governing framework for global health security date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: ea au c nan report, who seeks verifi cation from states parties in whose territory the event occurs. the declaration of a public health emergency of international concern is the crucial governance activity of the international health regulations. the director-general has sole power to declare and to terminate a public health emergency of international concern but must consider information provided by a state party; the decision instrument; emergency committee advice; scientifi c principles and evidence; and a risk assessment of human health, international spread, and interference with international traffi c. if the director-general declares a public health emergency of international concern, she must issue temporary, non-binding recommendations describing health measures that states parties should take. since , the director-general has declared three public health emergencies of international concern. during the h n infl uenza pandemic, who declared the fi rst ever public health emergency of international concern but was criticised for fuelling public fear. state parties widely disregarded who's temporary recommendations; , however, in , the review committee on international health regulations functioning during the h n infl uence pandemic cautioned, "the world is ill-prepared to respond to a severe infl uenza pandemic." in , the director-general declared two further public health emergencies of international concern, for polio and for ebola. the designation of polio seemed counterintuitive because only a handful of cases had been diagnosed compared with previous years. yet, small pockets of polio in afghanistan, pakistan, and nigeria were putting global eradication at risk. in the case of ebola, the director-general waited months after médecins sans frontières announced an "unprecedented outbreak" to declare a public health emergency of international concern on aug , . who's ebola interim assessment panel in july, , said urgent warnings "either did not reach senior leaders or senior leaders did not recognise their signifi cance." several health emergency events have not resulted in a declaration of a public health emergency of international concern. currently, the world is watching outbreaks of middle east respiratory syndrome, which has not triggered a public health emergency of international concern declaration despite reaching more than countries and causing deaths by november, . , the emergency committee advised that, without sustained community transmission, the conditions for a public health emergency of international concern have not been met. the director-general did not even convene an emergency committee for major events such as cholera in haiti, the fukushima nuclear disaster in japan, and the use of chemical weapons in syria. despite shortcomings, the international health regulations is an important governing framework. yet, a crisis of confi dence in the regulations exists, with the review committee on international health regulations functioning during ebola currently deliberating. we propose a series of operational and legal reforms. operational reforms are often preferable. amendments to the text of the international health regulations require world health assembly approval, do not enter into force immediately, and must be operationalised to be successful. furthermore, reopening the full text could entail a multiyear negotiating process, which risks weakening the international health regulations' norms and protection of human rights. even for our proposed legal reforms, we suggest ways to achieve them by textual interpretation and annex amendments in an attempt to avoid renegotiating the main text of the international health regulations. as shown in the fi gure, although none of the following proposed reforms is a solution on its own, collectively they could help to build a well functioning global detection and response system. some proposals will be easier to achieve than others, although all are needed reforms. achievement of core capacities by all states parties remains an indisputable baseline for preparedness. the initial deadline to meet the international health regulations' core capacities was , but who extended the deadline to for states parties. only states parties have affi rmed meeting core capacities. a well funded, prioritised, and comprehensive global plan is now past due. the november, , international health regulations review committee off ered a sound roadmap: strengthen self-assessment; test capacities through simulations; promote regional and crossregional learning; and measure performance through peer review and external assessments. such capacity building must go hand-in-hand with universal health coverage, a major target in the sustainable development goals. the following three recommendations could ( ) help with unofficial event reporting of potential public health emergencies of international concern develop publicly accessible online training platforms to assist in use of annex decision instrument develop a gradient for public health emergency of international concern declaration require states to automatically notify who of additional diseases that could become a public health emergency of international concern further increase transparency of emergency committee deliberations and findings the increasing assessed dues, although important to who's future, is politically fraught. alternative fi nancing mechanisms could include the global health security agenda, the world bank's proposed pandemic emergency financing facility, or a donors' conference. , , irrespective of the funding mechanism, ensuring sustainable resources would strengthen security for all. second, who should establish an independent peer-review core capacity evaluation system, with a feedback loop for continuous quality improvement. more rigorous evaluation of core capacities need to be undertaken. who allows states parties to self-assess their capacities, with many not reporting whether they have met their obligation to develop core capacities. states often resist external assessment because of sovereignty concerns, but the new system would aim to foster cooperation. domestic and external experts would work constructively with governments to identify capacity gaps, develop a jointly funded roadmap, and identify measurable benchmarks for success. if evaluations consistently led to technical and fi nancial assistance, states parties would be more likely to cooperate. third, civil society participation in reviewing core capacities should be enhanced. states parties' reports and who evaluations should be open to public scrutiny to increase transparency. as with other spheres of international law, such as human rights and climate change, civil society could off er "shadow" reports to states parties' reports and who evaluations and advocate for full funding of national capacities and fulfi lling international obligations. after facing criticism for disclosing the names of emergency committee members only after the h n public health emergency of international concern was terminated, who improved public trust by releasing member names for all subsequent emergency and review committees. who also pledged transparency about confl icts of interest. concerns persist, however, that emergency committees are infl uenced by politics rather than strictly reviewing scientifi c evidence. to increase transparency, who could publish full meeting minutes, provide web access to documents, and off er live updates through social media platforms. transparent emergency committee deliberations showing independence would build public trust, but reforms are of little value if the director-general does not convene an emergency committee. outside who's governing structure and drawing on civil society, an expert independent committee could convene to review data for disease outbreaks and recommend actions to the director-general. the world health assembly could amend the decision instrument to reduce states parties' reporting discretion, avoiding delayed notifi cation or verifi cation. presently, four diseases automatically require notifi cation. annex of the international health regulations could be modifi ed to require that additional listed diseases become automatically reportable. limiting states parties' discretion could simplify decision making and reinforce the norm of early notifi cation. routine notifi cations, moreover, would reduce the risk of under-reporting. guinean offi cials, for example, initially downplayed the risk, reporting only confi rmed ebola cases. procedurally, the world health assembly could update annex of the international health regulations as it did with annex regarding yellow fever vaccination. the ebola interim assessment panel said there was unawareness or incomplete understanding of international health regulations requirements at many levels. who could assist states parties in using the decision instrument by making international health regulations training publicly accessible through online platforms. the health security learning platform is a promising start, but is hard to fi nd on who's website; tutorials should be accessible without needing registration. furthermore, who should publicly acknowledge information received from non-governmental sources, and help with unoffi cial reporting. for example, to help gather real-time intelligence, who could develop web, phone, and tablet applications to report to who's strategic health operations centre. even if a state party does not corroborate an unoffi cial source, who should undertake its own analysis, sharing information transparently to the fullest extent possible in accordance with article of the international health regulations. the new web portal that who is developing for information sharing and transparency may assist in implementing this recommendation. a public health emergency of international concern declaration is the public face of who's outbreak response, but who has several instruments supporting earlier action. in view of the public symbolism of a public health emergency of international concern declaration, we believe that these emergency response frameworks must be integrated with international health regulations' processes. for example, who uses the emergency respons e frame work to inform the international community of an outbreak's severity in a graduated manner. a public health emergency of international concern declaration, however, would still be needed to raise the global alert, stiff en political resolve, and mobilise further resources. state and private industry disregard for who temporary recommendations-particularly travel and trade restrictions and injudicious quarantines-undermine the international health regulations. temporary recom mendations for ebola did not succeed on two fronts: the ebola-aff ected countries' health systems did not have the resources to implement who temporary recommendations; and states parties, because of domestic political pressure, disregarded temporary recommendations and did not discourage private disruptions of travel and trade, such as airlines cancelling fl ights. governments imposed additional measures, impeding deployment of health workers and medical supplies to the aff ected region. to enhance compliance, who should publicly request states parties to justify additional measures and urge businesses to reconsider restrictions. who should publicly acknowledge states parties and businesses that comply with temporary recommendations, while publicly naming those that impose unnecessary travel and trade restrictions. states parties should consider pursuing dispute mediation through the director-general or compulsory arbitration (article of the international health regulations). successful cases by states parties harmed by travel or trade restrictions or human rights violations would be a powerful precedent to enhance compliance. lastly, the world health assembly could amend the international health regulations to increase temporary recommendations to a binding status. even if temporary recommendations remain non-binding, trade restrictions could be challenged through the world trade organization, as mexico did during the h n pandemic. the inter national health regulations (article ) requires who to cooperate and coordinate its activities with intergovernmental bodies, including entering into formal agreements. these agreements could focus on one-health strategies, approaches based in the connections between human, animal, and environmental health. cooperative arrangements can help one-health strategies, such as reducing antibiotic use in animals and misuse in humans; monitoring and preventing zoological infections; ensuring secure handling of hazardous materials; and facilitating vaccine research. furthermore, equitable sharing of the benefi ts and burdens of scientifi c technology is crucial. the world health assembly should expand the pandemic infl uenza preparedness framework during its upcoming review of the framework and integrate it with the international health regulations. years after its adoption, the time has come to realise the international health regulations' promise. the unconscionable ebola epidemic opened a window of opportunity for fundamental reform-both for the international health regulations and the organisation that oversees the treaty. that political window, however, is rapidly closing. donor fatigue, fading memories, and competing priorities are diverting political attention. empowering who and realising the international health regulations' potential would shore up global health security-an important investment in human and animal health, while reducing the vast economic consequences of the next global health emergency. who. report of the ebola interim assessment panel ebola virus disease outbreak and follow-up to the special session of the executive board on ebola us departments of agriculture, state, and defense, and usaid. global health security agenda: toward a world safe and secure from infectious disease threats g . g- leaders' declaration who. states parties to the international health regulations swine infl uenza: statement by who director-general, dr. margaret chan responding to public health emergencies: report by the director-general who. implementation of the international health regulations ( ): report of the review committee on the functioning of the international health regulations ( ) in relation to pandemic (h n ) , doc. a / ebola toll rises in "unprecedented" epidemic ebola interim assessment panel. report of the ebola interim assessment panel mers in korea: why this outbreak can be stopped soon middle east respiratory syndrome (mers): frequently asked questions and answers who. who statement on the eighth meeting of the ihr emergency committee regarding mers-cov who. report of the fi rst meeting of the review committee on the role of the international health regulations report of the review committee on second extensions for establishing national public health capacities and on ihr implementation: report by the director-general pandemic emergency facility: frequently asked questions ebola: what lessons for the international health regulations report of the review committee on the functioning of the international health regulations ( ) in relation to the pandemic (h n ) , doc. a / who. frequently asked questions on ihr emergency committee emails: un health agency resisted declaring ebola emergency international health regulations: strategic health operation centres director-general addresses g health ministers on ebola emergency response framework who. current who phases of pandemic alert for pandemic (h n ) all authors contributed equally to the report. key: cord- -ovp qrqt authors: tokuç, burcu title: which threats to global health pose a problem for turkey’s health? date: - - journal: balkan med j doi: . /balkanmedj.galenos. . . . sha: doc_id: cord_uid: ovp qrqt nan according to the limits set by the who, out of provinces of turkey are exposed to polluted air; furthermore, based on the national air quality limits, % of the cities have poor air quality ( ) . an estimated , premature deaths occur every year due to air pollution ( ) . another glaring indication of the magnitude of this problem is the who data that reveals the incidence of premature deaths due to air pollution in turkey ( . deaths per , individuals) to be . times the who european region average ( ) . climate change, which affects public health in many different ways, is estimated to lead to , additional deaths annually from malnutrition, malaria, diarrhea, and heat stress ( ). the national action plan on climate change revealed that the average annual temperature is estimated to rise by . °c- °c in the next few years in turkey ( ). despite such foreboding data, turkey is yet to establish effective environmental protection policies and/or take adequate environmental protection measures. non-communicable diseases, such as diabetes, cancer, and heart disease, are collectively responsible for over % of deaths worldwide, an estimated million people. this covers million premature deaths in people aged - years. five major risk factors contribute to the increase in the incidence of these diseases: tobacco use; physical inactivity; excessive intake of alcohol; unhealthy diets; and air pollution. according to the latest data released by the ministry of health ( ), the greatest increase in disease burden in years was observed in alzheimer's disease ( . % increase) and in stroke ( . % increase), while the most significant reduction was observed in lower respiratory tract infections ( . % decrease). noncommunicable diseases contribute to . % of deaths in turkey ( ) . the probability of premature death due to four non-communicable diseases is likely one sixth ( . %) for an individual in turkey ( ) . a study of the prevalence of risk factors for non-communicable diseases in turkey reported tobacco use in . % of individuals. additionally, . % of individuals in the study group were overweight [body mass index (bmi) ≥ kg/m ], . % were obese (bmi ≥ kg/m ), and . % had insufficient physical activity with median time of min per day spent performing physical activity ( ) . most early deaths from non-communicable diseases can be largely prevented by making health systems more equitable and responsive to the healthcare needs of these patients, and by collaborating with non-health sectors. to carry out these commitments, the world health assembly (that turkey is a member of) approved the - action plan for global non-communicable disease prevention and control in may . the goal "to reduce and surveillance of the incidence of noncommunicable diseases and their risk factors" has received wide coverage in the republic of turkey ministry of health strategic plan and action plan - , and some strategies have been identified ( ) . the strategies for this goal are as follows: to raise awareness of noncommunicable diseases and risk factors; to establish a surveillance system for monitoring and management of non-communicable diseases; and to strengthen the prevention and control programs for non-communicable diseases. however, as of , these strategies have not achieved the desired success in reducing noncommunicable diseases in turkey. antimicrobial resistance is one of the most fundamental issues of the global agenda in recent years due to its public health impact and economic cost. in terms of antibiotic use, turkey ranks first among the organization for economic co-operation and development countries and second in antimicrobial resistance ( ) . the misuse of antibiotics, lack of regulation of livestock, lack of information among health workers, and insufficient political arrangements are the problems faced by turkey that need effective solutions. one of the priorities in this context is to increase data collection and monitoring mechanisms for all agricultural and health practices. programs for the reduction of antibiotic institutions and organizations in turkey in recent years, and new policies are put into practice. significant progress and increased awareness has been created such that antibiotics are no longer sold without prescription in turkey. moreover, surveillance studies on the use of antibiotics in both humans and animal husbandry are on the agenda ( ). unfortunately, since , anti-vaccine groups that confuse people by spreading incorrect information are rapidly increasing in turkey. parents are coming together through a platform called "i don't have to vaccine my child". ensuring high immunization coverage and expanding vaccine access to those who are being missed are crucial parts of universal health coverage. in turkey, the number of families who refused to have their children vaccinated increased from , in to , in . if vaccination is interrupted, up to , children may lose their lives each year due to vaccine-preventable diseases leading to an economic loss of billion euros ( ) . vaccination services are a public responsibility. therefore, in the light of scientific data, the public should be informed about vaccine-preventable diseases, legal arrangements should be made for the protection of the people at risk, and educational tools to disprove anti-vaccine theses should be developed. turkey is yet to take effective steps in this regard. it should be noted that the government's inability to enact laws on this subject can be considered as a criminal offense against the positive duty obligation. the authorities should follow a clear and consistent approach. a large fraction ( %) of the world's population lives in countries with prolonged humanitarian crises, grappling with the challenges of drought, famine, conflict, and population displacement. turkey has a significant refugee problem because of these conditions at the country's borders. the refugee population that escaped the war in syria exceeds . million, of which , are babies born in turkey ( ) . for preventing the problems faced by more than million syrians in the places where they currently live and to ensure that health services are easily accessible to them, migrant health units have been established wherein primary health care services are provided. currently, migrant health centers are in service in turkey ( ) . although a large number of migrant health centers have been set up, they merely strengthen health systems to combat war and hunger and constitute a temporary solution without fixing the main problem. unfortunately, the main problem can only be solved by the initiatives of the international community. the primary health care (phc) system meets a majority of an individual's health care needs throughout their life. a healthcare system with a strong phc always provides better and more efficient healthcare and quality care. health systems need strong phc at their core if they are to achieve universal health coverage and health-related sustainable development goals ( ) . innovations in health care, arrangements in primary care and family medicine system, and effective and accountable health management are the key steps toward our goal for strengthening phc services. according to the turkish ministry of health statistics, since the first human immunodeficiency virus/aids case in in turkey , people have been diagnosed as human immunodeficiency virus positive and the number of human immunodeficiency virus positive patients has increased by % over the past years ( ) . therefore, turkey has experienced the most increase in the number of human immunodeficiency virus positive patients in the world. with the support of the who, turkey introduced self-testing to provide information to maximum human immunodeficiency virus positive patients about their status for treatment or preventive measures. more influenza pandemic is expected; however, experts do not know where, when, and how severe will it be. in case of a global outbreak, the health system should be strengthened and prepared for emergencies. ebola and several other hemorrhagic fevers, including zika, nipah, middle east respiratory syndrome coronavirus, severe acute respiratory syndrome, disease x, and dengue, that could cause serious epidemics have not yet been health threats for turkey. the above-mentioned list is an indication of changing health challenges, and that non-communicable diseases and environmental threats pose just as great a risk for the future. while talking about threats to health, there is a need to focus on systemic problems that threaten our healthy living conditions, while emphasizing health services. the underlying causes of non-communicable diseases are systemic and environmental problems that cannot be solved by health services alone. therefore, emphasizing the effects of environmental pollution in our country (where the environmental struggle is becoming increasingly difficult), advocating for the health of the public and not the interests of the market, and sustaining this struggle in an organized manner within local, national, and international organizations is very crucial. the who published a list of ten health threats that will require more attention in . to address these issues, the who is beginning a clean air platform. air pollution in turkey: black report turkish ministry of health. turkey statistics yearbook- türkiye hanehalkı sağlık araştırması: bulaşıcı olmayan hastalıkların risk faktörleri prevalansı (steps). dünya sağlık Örgütü türkiye ofisi republic of turkey ministry of health strategic plan and action plan antimicrobial resistance the horrific trend of the anti-vaccine movement in turkey de suriyeli sığınmacılara yönelik sağlık politikaları primary health care number of hiv patients in turkey up fourfold in last years which threats to global health pose a problem for turkey's health? key: cord- -v ff jd authors: long, nathaniel; wolpaw, daniel r.; boothe, david; caldwell, catherine; dillon, peter; gottshall, lauren; koetter, paige; pooshpas, pardis; wolpaw, terry; gonzalo, jed d. title: contributions of health professions students to health system needs during the covid- pandemic: potential strategies and process for u.s. medical schools date: - - journal: acad med doi: . /acm. sha: doc_id: cord_uid: v ff jd the covid- pandemic poses an unprecedented challenge to u.s. health systems, particularly academic health centers (ahcs) that lead in providing advanced clinical care and medical education. no phase of ahc efforts is untouched by the crisis, and medical schools, prioritizing learner welfare, are in the throes of adjusting to suspended clinical activities and virtual classrooms. while health professions students are currently limited in their contributions to direct clinical care, they remain the same smart, innovative, and motivated individuals who chose a career in health care and who are passionate about contributing to the needs of people in troubled times. the groundwork for operationalizing their commitment has already been established through the identification of value-added, participatory roles that support learning and professional development in health systems science (hss) and clinical skills. this pandemic, with rapidly expanding workforce and patient care needs, has prompted a new look at how students can contribute. at the penn state college of medicine, staff and student leaders formed the covid- response team to prioritize and align student work with health system needs. starting in mid-march , the authors used qualitative methods and content analysis of data collated from several sources to identify categories for student contributions: the community, the health care delivery system, the workforce, and the medical school. the authors describe a nimble coproduction process that brings together all stakeholders to facilitate work. the learning agenda for these roles maps to hss competencies, an evolving requirement for all students. the covid- pandemic has provided a unique opportunity to harness the capability of students to improve health. other ahcs may find this operational framework useful both during the covid- pandemic and as a blueprint for responding to future challenges that disrupt systems of education and health care in the united states. is a global pandemic, threatening individuals and disrupting communities and economies. the impact on all u.s. health systems continues to escalate, and health systems are undergoing rapid operational change to meet the demands. as leaders in complex care, research, and medical education, u.s. academic health centers (ahcs) are in many ways at the epicenter of this storm, which means that our medical students are fellow travelers, and their professional pathways are profoundly affected. [ ] [ ] [ ] no aspect of the tripartite mission of ahcs-clinical care, education, and research-has been untouched by the crisis. clinical operations are pivoting to covid- preparation; research labs are closing as part of mitigation efforts; and medical schools, prioritizing learner welfare, are in the throes of adjusting to suspended clinical activities and remote learning. the overall impact on medical education programs is unprecedented and rapidly evolving. but while normal learning activities are disrupted and schools are scrambling to adjust, the passion of our students to contribute to the needs of people and health systems in this crisis remains very much alive and well. [ ] [ ] [ ] although many faculty find teaching to be rewarding and validating, traditional curricular designs have not used medical students' potential to cocreate and offer value to the health system. as a result, faculty often consider teaching medical students in the first few years of their curriculum as extra work, added time, and decreased efficiency. substantive learner contributions are often viewed as coming in year or during residency. recent advances in medical education, however, have focused on developing the concept of value-added medical education. , this is defined as "experiential roles that have the potential to positively impact individuals and population health outcomes, cost of care, or other processes within the healthcare system, while also enhancing student knowledge, attitudes, and skills in the clinical or health systems sciences." examples of value-added roles include student patient navigators, clinical care extenders, advocates, and resource managers. [ ] [ ] [ ] [ ] [ ] necessity is the mother of invention, and currently, u.s. ahcs have the unique opportunity to operationalize the concept of value-added medical education in this escalating crisis, exploring how medical and other health professions students can contribute to the acute and overwhelming needs of health systems and the populations they serve. in the face of the evolving covid- pandemic, our team used qualitative methods and a content analysis of data collated from several sources-a literature review, a modified crowdsourcing method used to gather student perspectives, discussions with health system leaders, and the covid- pandemic poses an unprecedented challenge to u.s. health systems, particularly academic health centers (ahcs) that lead in providing advanced clinical care and medical education. no phase of ahc efforts is untouched by the crisis, and medical schools, prioritizing learner welfare, are in the throes of adjusting to suspended clinical activities and virtual classrooms. while health professions students are currently limited in their contributions to direct clinical care, they remain the same smart, innovative, and motivated individuals who chose a career in health care and who are passionate about contributing to the needs of people in troubled times. the groundwork for operationalizing their commitment has already been established through the identification of value-added, participatory roles that support learning and professional development in health systems science (hss) and clinical skills. this pandemic, with rapidly expanding workforce and patient care needs, has prompted a new look at how students can contribute. at the penn state college of medicine, staff and student leaders formed the covid- response team to prioritize and align student work with health system needs. starting in mid-march , the authors used qualitative methods and content analysis of data collated from several sources to identify categories for student contributions: the community, the health care delivery system, the workforce, and the medical school. the authors describe a nimble coproduction process that brings together all stakeholders to facilitate work. the learning agenda for these roles maps to hss competencies, an evolving requirement for all students. the covid- pandemic has provided a unique opportunity to harness the capability of students to improve health. other ahcs may find this operational framework useful both during the covid- pandemic and as a blueprint for responding to future challenges that disrupt systems of education and health care in the united states. health system needs during the covid- pandemic: potential strategies and process for u.s. medical schools communication with frontline physician educators-to develop strategies for leveraging student capabilities and contributions. in this article, we ( ) articulate categories in which medical students can contribute to the work of u.s. ahcs and the wellness of their communities; ( ) describe the educational benefits for learners and the alignment with health systems science (hss) competencies; and ( ) highlight a process for coproduction between students, medical schools, and the health system. our goal is to develop an operational framework that other ahcs can use in this crisis and to provide a blueprint for responding to future challenges that disrupt our systems of education and health care. in mid-march , anticipating the arrival of the covid- pandemic in south central pennsylvania, education and student leaders from the penn state college of medicine (pscom) collaborated with penn state health system leaders on a process for strategically identifying avenues for meaningful student contributions to meeting workforce needs. primed by a well-established curriculum in patient navigation and hss and encouraged by an invested faculty, over students (primarily medical students with contributions from students in public health [mph and drph], nurse practitioner, and physician assistant programs) made commitments to contribute to the pandemic within the first weeks. the initial planning phase, which was rapid and nimble, was guided by the goal of safely integrating students into supervised interprofessional work projects that would contribute directly to the needs of penn state health and the community, while also providing educational benefits. a covid- response team was quickly established with student codirectors. to capture the energy of the moment, several early projects were piloted while a concurrent intentional analysis of needs was performed. we sought to collect a broad and diverse range of ideas from multiple stakeholders, including students, educators, and system leaders. we then performed a focused literature review, inclusive of our prior works related to value-added medical education. [ ] [ ] [ ] [ ] [ ] our team employed a modified crowdsourcing method, which included soliciting open-ended suggestions for activities from all pscom medical students in google docs, on social media platforms, and via personal email communications. simultaneously, we asked both administrative leaders and clinical faculty within our health system to identify vital system needs. a lead author (j.d.g.) also personally contacted physician educators at several u.s. ahcs to explore their perspectives on possible needs. lastly, we reviewed information on social media platforms to gather ideas from other medical schools. using this dataset, we performed a content analysis, collapsed ideas into similar roles, and grouped all tasks into overarching categories. , our underlying assumptions were that students bring maturity and commitment, medical and health care delivery awareness, technological competency, creativity in problem solving, and community understanding to the current challenge, making them uniquely positioned to provide valuable contributions. on the basis of our analysis, we identified categories of projects for our health professions students. below we describe each of these categories, and table lists potential and active tasks (n = ) with descriptions for each. we identified various roles in which students could contribute to increasing the understanding of the pandemic in the neighborhoods and communities in the region surrounding pscom. these roles leverage students' knowledge of the communities' strengths and weaknesses to promote large-scale awareness and strategies to remain safe and flatten the curve of the pandemic (e.g., social distancing, handwashing, etc.). several projects and tasks focus on expanding the workforce for emerging pandemic-specific needs (e.g., telehealth encounters, follow-up check-ins, patient rescheduling, etc.) as well as the ongoing work of caring for non-covid- patients (discharge navigation, etc.). in addition, health system leadership identified the need for an evidencebased medicine team to assist them in answering questions. this team creates daily succinct summaries of emerging information regarding covid- from a breadth of perspectives to facilitate strategic and clinical decision making within the ahc. we identified several projects and tasks that allow students to support the needs of caregivers and staff-the workforce of the health system. ensuring frontline clinicians and staff can remain in their jobs requires assisting them in their life responsibilities outside of work, including childcare, maintaining a food supply, running errands, and attending to personal well-being. the modification of clerkships and in-person educational experiences has forced medical schools into uncharted territory. the curriculum has transitioned exclusively to an online format. some traditional activities can be replicated or approximated, but many will require creative and innovative changes that necessitate active student engagement. the students are key stakeholders and contributors, offering technological expertise and piloting innovative ideas for curriculum development and implementation. after identifying a comprehensive list of projects and tasks, we developed a process for prioritizing activities by working with students and medical school and health system leadership. our first action was to collaborate with the legal department to ensure appropriate safety and regulatory steps, based on principles that the medical school and health system leadership had created and agreed upon, were in place. most notably, it was evident that activities students engaged in would need to be accomplished remotely, without direct patient or team contact, and under adequate supervision of penn state faculty or staff. in addition, an important distinction emerged between efforts that students developed independently and operated outside of our health system, such as regional blood banking programs, and efforts that the health system solicited from students and cocreated with them by using their ongoing feedback and input (e.g., covid- follow-up calls, contact tracing, etc.). while participation in all activities is completely voluntary, projects officially approved by the health system and medical school require a standard of recognition that adheres to the guiding principles and includes either curricular credit or monetary compensation. regardless of training year, each student participating in a task force is enrolled for a time-variable elective credit (e.g., credit for each hours, maximum credits), which can fulfill elective requirement for postclerkship students; the associate dean for health systems education (j.d.g.) provides formal oversight for all electives. see table for a description of projects and designation of key features. we quickly learned the importance of a formal organizational structure featuring coproduction, well-defined roles, clear workflow, and regular communication. figure depicts our covid- response team, the relationship of students to pscom and penn state health leadership, and a workflow designed to consider student and faculty ideas while ensuring collaboration and prioritized task force assignments. with a rapidly evolving landscape of system and patient needs, student efforts must be channeled thoughtfully to maximize value and safety. this structure was established to ensure that new tasks and ideas continue to meet legal requirements and are free a since the creation of the task forces at the penn state college of medicine in mid-march , the number of students involved in task forces has been dynamic. six weeks into the program (mid-to late april), the total number of students on task forces or awaiting placement = ; students onboarded to functioning task forces = (medical students = , public health students = , nurse practitioner students = , physician assistant students = ). at that date, the breakdown by category was as follows: category = (contact tracing = ), category = (patient navigator discharge = ), category = , category = (medical school and logistics planning = ). priorities were assigned to the task forces on the basis of how many of the key features ( right-hand columns) they have. b educational value relates to learning in systems-based practice/health systems science (e.g., identification of health system gaps and improvement processes, application of core systems principles to the pandemic, contribution to system needs), interpersonal and communication skills, interprofessional collaboration, knowledge for practice, and professionalism. of ethical or coercive conflicts, formally approved by pscom, and systematically address the most pressing needs of the health system. a developmental cascade starting with principles and workflow allowed for further clarification and prioritization of potential opportunities (see table ). many of these tasks were variations of roles that had already existed in our curriculum (e.g., students as patient navigators), and others emerged from system needs (e.g., evidence-based medicine consultants, telehealth extenders, etc.). [ ] [ ] [ ] [ ] [ ] several tasks were proposed by faculty members who were shifting their research and clinical work to meet the needs of the pandemic and sought collaboration to extend the workforce to perform these tasks (e.g., an internal medicine physician leading contact tracing, a geriatrician leading long-term care facility outreach). the willingness of leaders and faculty to invest time and energy in this system highlights the value-added nature of the task forces. in mid-to late april , within month of discussion and planning, we launched task forces, and the work has substantially benefitted our health system and community. for example, by the end of april, the contact tracing task force has onboarded + students who have called over patients with covid- and their contacts to inform and educate them on infection control measures. we fully anticipate the work of these task forces will change, blend figure depiction of the covid- response team workflow in identifying, prioritizing, and establishing task forces for student contributions during the pandemic. ideas from the health system, medical school, and students are reviewed and prioritized by the covid- response team, composed of health system leadership (executive vice president/chief clinical officer and/or his or her designee) and medical school leadership (vice dean for educational affairs, associate dean), and student leaders. the covid- response team chooses ideas for task forces that meet legal guidelines, are deemed of high need to the health system, and are of educational value (see table ). the covid- response team establishes each task force by designating a student and a faculty leader, who work together to create goals, collaborate with entities needed for specific tasks (e.g., department of health), and oversee the recruitment/preparedness of students. faculty leaders include a diverse group of physicians (e.g., surgery, internal medicine, family and community medicine), nurse practitioners, and social workers. once a process has been developed and the number of students needed has been determined, students are onboarded via voluntary sign-ups and formally enrolled in the elective. the faculty member and student lead ensure appropriate training for each task and assist with assessing student progress, logging of hours, compliance, and contributions to the task force. huddle groups between various levels of the covid- response team allow for collaboration and feedback to ensure the dynamic needs of the task forces, health system, and medical school are met. with other groups, or phase out as the pandemic continues to evolve and affect our communities as well as our personal and professional lives. however, this coproduction process can provide the longitudinal and sustainable methods for work through the pandemic, even as health systems face unprecedented adaptations. this model for the development and implementation of task forces with interprofessional stakeholders provides an efficient and effective process to adapt and respond to changing health care needs, even if legal parameters and hospital policies change. such changes may include the most extreme hypotheticals, such as having students rejoin the workforce on the frontlines. we learned the following lessons, which other medical schools may want to consider. hss, with roots in george engel's biopsychosocial model and the systembased practice competency domain of the accreditation council for graduate medical education, has emerged as a major focus in medical education and includes competencies in health care delivery, social determinants of health, high-value care, change management, and systems thinking. [ ] [ ] [ ] [ ] [ ] [ ] this growth has mirrored an increased recognition of the importance of hss in the care of patients and populations and reflects the needs of health systems that are undergoing transformation. educators and students increasingly understand how the contexts of our patients and care environments are critical to learning and health. at the same time, health system leaders are increasingly looking for the hss perspective and skill set in their workforce. seven years ago, pscom began a comprehensive curricular program of classroom and experiential learning in hss. those students who developed an evolved skill set-serving as patient navigators for individuals in need, obtaining white and yellow belt certifications in operational excellence, and honing a nascent systems-based perspective toward health care practice-are the same students who have been organizing themselves to perform similar and additional roles during the covid- pandemic. their formal studies have been interrupted, but their professional path, the way they see themselves as collaborators and contributors in health care, is thriving. at the same time that education and experience in hss have primed our students to contribute in this pandemic, the crisis is setting up a unique opportunity for students to deepen and extend their learning in hss, as well as interpersonal communication, knowledge for practice, and professionalism. recognizing this, our medical school has been able to accelerate the approval of a health systems and covid- response elective for students across all phases of the curriculum. in line with an outcomesbased educational model, task force activities and reflection assignments map to our hss competencies, and continual feedback ensures a growth mindset for all parties involved (formal course proposal available upon request). we believe the covid- pandemic is an ideal opportunity for students to contribute to the needs of the health system while also helping them develop systems-based competencies and the mindset necessary for forming an evolved professional identity. [ ] [ ] [ ] [ ] "systems citizens" are physicians who not only care for individual patients but also know how to perform in developing systems of care, embodying the motivation to grow and contribute to the evolution of the health care system itself. continually improving our systems of care-in response to pandemics and beyond-will require all physicians to have this skill set and professional identity. [ ] [ ] [ ] [ ] coproduction between students, medical school, and health system the convergence of education and system needs around hss described above has created a unique opportunity to realize coproduction between key stakeholders. while the potential for this collaboration has been present for some time, there has been no urgent motivation to make it happen. there have been important initiatives, but there has also been a tendency for stakeholders on all sides to function independently. the covid- pandemic has upended many businessas-usual perspectives and activities and has vividly and tragically brought the potential for coproduction into high relief. the table has been set by health systems and education programs, and now we have passionate, skilled students sitting at the table with a wide range of stakeholders and leaders to think and plan together. coproduction is no longer just a possibility or an idea; it is playing out in our programs and likely in medical centers all over the country. the covid- pandemic is challenging our ahcs and our local, national, and global communities in tragic and unprecedented ways. confronting this crisis is prompting widespread reexamination of what we thought we knew, how we act, and how we respond to adversity. as we are distracted by events and responses, we are also opening to new opportunities. it has been easy to talk about students as our junior colleagues and the future of our profession, but those words do not always translate into what we do and how we do it. it is comfortable to envision a steady progression of professional development through incremental biomedical coursework, clinical training, and responsibility. but the reality is that for several years, hss and associated added-value roles have been opening up a distinct, equally important thread within students' professional development. the feasibility, validity, and impact of these approaches have been well documented and widely disseminated. [ ] [ ] [ ] [ ] [ ] and we know that health systems value and very much need an hss professional development pathway for their future workforce. many educators and system leaders have recognized this need, but work toward achieving the goals of authentic codevelopment of roles and the invitation to contribute has been slow. in this tragic time of covid- , nothing is slow. many things, too many bad but some good, have been brought into stark relief. one that stands out clearly on the positive side is how we can come together-the health system and education leaders, faculty and staff, and students-to make a difference. our hope is that the program of aligning missions and employing coproduction to create value-added participatory roles for students can serve as a blueprint for other medical schools as we continue to navigate these uncharted waters. world health organization american hospital association. updates and resources on novel coronavirus (covid- ) the evolving academic health 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responsibility to improve the quality of care the fifth discipline: the art and practice of the learning organization. rev and updated ed systems citizenship: the leadership mandate for this millennium educating patient-centered, systems-aware physicians: a qualitative analysis of medical student perceptions of value-added clinical systems learning roles curricular transformation in health systems science: the need for global change coproduction of healthcare service acknowledgments: the authors would like to express their deepest gratitude to all the health professions students at penn state college of medicine who have dedicated time to these initiatives to improve patient health and strengthen our community. key: cord- -t g dj authors: brian, zachary; weintraub, jane a. title: oral health and covid- : increasing the need for prevention and access date: - - journal: prev chronic dis doi: . /pcd . sha: doc_id: cord_uid: t g dj populations disproportionately affected by coronavirus disease (covid- ) are also at higher risk for oral diseases and experience oral health and oral health care disparities at higher rates. covid- has led to closure and reduced hours of dental practices except for emergency and urgent services, limiting routine care and prevention. dental care includes aerosol-generating procedures that can increase viral transmission. the pandemic offers an opportunity for the dental profession to shift more toward nonaerosolizing, prevention-centric approaches to care and away from surgical interventions. regulatory barrier changes to oral health care access during the pandemic could have a favorable impact if sustained into the future. on march , , the world health organization declared the global spread of coronavirus disease (covid- ) a pandemic ( ) . severe acute respiratory syndrome coronavirus (sars-cov- ) is a new virus with no vaccine or treatment, and the population currently has no immunity. the virus is primarily transmitted by direct or indirect personal contact through airborne respiratory droplets from an infected person ( ) . on march , , the american dental association (ada), the nation's largest dental association, recommended that dental practices postpone elective dental procedures until april , , and provide emergency-only dental services to help keep patients from burdening hospital emergency departments ( ) . because of the rise of infections, this recommendation was updated on april , , when the ada advised offices to remain closed to all but urgent and emergency procedures until april at the earliest. as a result, access to dental care substantially decreased. during the week of march , , an ada health policy institute survey indicated that % of dental offices surveyed were closed but seeing emergency patients only, % were completely closed, and % were open but seeing a lower volume of patients ( ) . in addition to the lack of widespread covid- testing, point-ofcare testing in dental offices also was not available. because of the inability to test all patients and the fact that asymptomatic or presymptomatic patients could be infectious, ada guidance shifted in mid-april as state and local government policies varied regarding criteria for reopening different types of services, including dental services ( ) . questions remain about how soon patients will prioritize and resume nonemergency dental care amid other delayed health care services. the full extent of pandemicrelated financial strain and loss of dental insurance is not yet clear and will dramatically affect dental care utilization. in this commentary, we explain why oral health care should be a public health priority in the response to the pandemic and discuss the aspects of dental care that make it challenging to accomplish this. we will also provide opportunities for improvement, such as focusing more on prevention and nonaerosolizing dental proced-ures and the means by which to increase access to affordable, more equitable care for vulnerable populations. in , the first and only surgeon general's report on oral health (the second is in progress) made clear that oral health is part of overall health and well-being ( ) . the mouth is indispensable to eating, speaking, smiling, and quality of life. the most prevalent oral conditions are dental caries and periodontal diseases, and they are largely preventable ( ) . dental caries is the most common chronic childhood disease and continues into adulthood. among us adults, - national data indicate that . % had untreated dental caries ( ) . furthermore, according to weighted averages from through , % of adults aged or older had periodontitis ( ) . oral disease is unevenly distributed in the population by race and ethnicity ( table ). the progression of oral disease can cause pain, infection, and sepsis, and treatment is expensive. in addition to primary prevention, in early stages the progression can be reversed or arrested with appropriate oral hygiene, fluoride exposure, dental sealants, changes in diet, and other measures. populations with oral health and chronic disease disparities: covid- puts both at increased risk populations at higher risk for many chronic diseases are similar to those at higher risk for developing oral diseases. common risk factors include stress, poor diet, alcohol and tobacco use, substance misuse, behavioral health issues, domestic violence, and poverty. many of these factors have been heightened during the pandemic. these and other social determinants of health lead to both exacerbation of chronic disease and poor oral health outcomes ( ) . populations vulnerable to covid- , including those in low socioeconomic groups, minority groups, older adults, low-literacy individuals, those in rural areas, and the uninsured are also at increased risk for oral disease and associated systemic health problems ( ) . minority populations are especially at risk during the covid- pandemic. the centers for disease control and prevention (cdc) notes that "non-hispanic blacks, hispanics, and american indians and alaska natives generally have the poorest oral health of any racial and ethnic groups in the united states," ( ) and these same populations have disproportionately higher incidence of covid- -related infection and death ( ) . among those hospitalized with covid- , diabetes and cardiovascular disease are of the most prevalent underlying comor-bidities, according to the cdc ( ) . periodontal disease is associated with diabetes and cardiovascular disease, although causality is difficult to ascertain because of confounding evidence, and few randomized trials or longitudinal studies have been conducted on the effects of treatment ( , ) . researchers note, "the covid- pandemic has alarming implications for individual and collective health and emotional and social functioning" and that "health care providers have an important role in monitoring psychosocial needs and delivering psychosocial support to their patients" ( ). research suggests a strong association between oral health conditions like erosion, caries, and periodontal disease and mood conditions like stress, anxiety, depression, and loneliness ( ) . there are other potential connections downstream between covid- and oral health. with the covid- pandemic's impact on mental health, pandemic-related increases in oral health risk factors, and anticipated declines in per capita dental visits, increasing integrated practice and referrals between dental providers and behavioral health providers will be prudent. similarly, increased efforts to more effectively integrate dental programs focused on prevention, screening, and risk assessment within primary care, obstetrics and gynecology, and pediatric offices should be pursued to expand access to oral health services for vulnerable populations ( ) . access to oral health care is especially limited for populations at high risk for covid- . patients with symptoms of covid- are advised "to avoid nonemergent dental care" ( ) . providers are advised, "if possible, [to] delay dental care until the patient has recovered" ( ) . more than million us residents live in areas designated by the health resources and services administration as dental health professional shortage areas ( ) . this shortage has been compounded by the covid- pandemic, which has resulted in limited preventive dental services in the interest of public health safety. emergency departments, a less-than-ideal but common treatment destination for those facing oral health care access disparities, have also seen a significant drop in visits for health problems unrelated to covid- ( ) . school-based oral health programs, such as effective dental sealant programs to prevent dental caries -the only source of preventive oral health care for many children in vulnerable populations -have similarly been suspended because of government-mandated school closures ( ) . nationally, children in low-income families and at higher risk of caries are less likely to receive sealants than children in higherincome families, at % and %, respectively ( ) . access disparities are particularly acute for poor and minority populations. researchers note that "poor and minority children are substantially less likely to have access to oral health care than their nonpoor and nonminority peers" ( ) . these populations are also more likely to lack dental insurance. a report notes, "the oral health care safety net is expected to cover . . . one-third of the us population, notably those who are low-income, uninsured, and/ or members of racial/ethnic minority, immigrant, rural, and other underserved groups" ( ) . many of these populations, which often rely on medicaid dental benefits, have seen their access restricted or eliminated by reductions in this vital coverage. in it was reported that "in response to fiscal challenges, many states have reduced or eliminated medicaid dental coverage over the past decade, with a concurrent % decline in oral health care utilization among low-income adults" ( ) . among those in at-risk populations who do have dental benefits under medicaid, the same report notes there is often "difficulty finding medicaid-contracted dental providers, because only % of dentists nationwide accept medicaid" ( ) . we can reasonably anticipate a worsening of these trends as the covid- pandemic takes a large proportion of state budgets. dental professionals have been practicing increased infection control and taking universal precautions since the s hiv epidemic ( ) . nevertheless, oral health professionals are among those occupations at the highest risk for covid- , as reported by the new york times ( ) . dental care personnel face challenges because of their proximity to infected patients. these patients' mouths are open and unmasked during treatment, significantly increasing the potential for direct and indirect exposure to infectious materials. the occupational safety and health administration designates the performance of aerosol-generating procedures on known or suspected covid- patients as "very high risk" ( ) . shortages of personal protective equipment (ppe) and the use of instruments and equipment that generate aerosols containing oral and respiratory fluids only compound the risk ( ) . two of the highest aerosol-creating procedures involve inventions that have been considered major advances in dental practice, because they are faster and less painful for the patient: the high-speed handpiece with its water spray coolant and the ultrasonic scaler used by hygienists to remove hard deposits on teeth ( ) . these dental procedures have become problematic during the pandemic, providing an opportunity to shift to nonaerosolizing procedures and a greater focus on prevention ( , ) . focus on prevention and promote nonaerosolgenerating dental procedures prevention is a cornerstone of public health. the covid- pandemic presents an opportunity for the dental profession to shift from an approach focused on surgical intervention to one emphasizing prevention. embracing nonsurgical, nonaerosolizing caries prevention and management will be critical in this endeavor. the profession has always supported community water fluoridation, and dental hygienists are considered prevention experts ( , ) . however, the dental compensation model is based on providing expensive, restorative procedures that are financially out of reach for many people. guidelines have been developed to shift the dental care paradigm to a more preventive focus ( ) ( ) ( ) ( ) ( ) . strategies include reduction in common risk factors such as tobacco and alcohol use, promotion of a healthy diet low in sugars, community water fluoridation, topical fluorides, and promotion of oral health in community settings. these oral health messages and interventions should be integrated into medical sites such as primary care and pediatric offices. prevention and nonsurgical caries management include many options. evidence-based materials include dental resin sealants, glass ionomers as sealants or as part of atraumatic restorative treatment performed with hand instruments, silver diamine fluoride, sodium fluoride varnish, and other self-applied and professionally applied topical fluorides ( ) ( ) ( ) . these materials can be applied without generating aerosols, reducing the risk of viral transmission. these methods present a major opportunity to expand access to preventive and restorative care for vulnerable populations, particularly when combined with policy changes increasing hygienists' scope of practice, sustainable payment reform, and changes in the education of oral health professionals. providers and payers together have a responsibility to shift toward preventive care, particularly as covid- threatens to increase disparities in oral health care access for the united states' most vulnerable populations. before the pandemic, birch et al noted that a review of provider and payer practices made clear that "further work was required on both the provider and payer side to ensure that evidence-based prevention was both implemented properly but also reimbursed sufficiently" ( ) . as health care compensation moves toward value-based care and a focus on health outcomes, prevention and maintaining oral health and sound tooth structure will shift reimbursement away from the current expensive model of reimbursement for restoration of tooth structure and preventing chronic disease www.cdc.gov/pcd/issues/ / _ .htm • centers for disease control and prevention function ( ) . in particular, reimbursement policies, which traditionally have incentivized surgical, high-end restorative procedures like crowns and multisurface fillings, must be revisited to prioritize preventive and nonsurgical, nonaerosolizing treatments and make them more financially sustainable. communications concerning patient and provider safety are critical ( ) . surveillance and monitoring are needed to confirm whether transmission of covid- occurs in the dental office. according to cdc ( ) , "there are currently no data available to assess the risk of sars-cov- transmission during dental practice." the availability of ppe for dental care should be monitored, and the effectiveness of various types of ppe should be determined. many oral health care providers are anxious about returning to work, and many patients may be hesitant to enter a dental office. communication and clarity are critical, especially with low-literacy populations. messaging should include the importance of maintaining good oral health and its role in overall health. dental coverage under medicaid is mandated for children, but state medicaid programs' approaches to oral health services for adults vary significantly, especially in terms of the comprehensive nature of such services (figure) . only states have "extensive" medicaid dental benefits for adults ( ). among us adults aged to , only . % have medicaid dental benefits and, alarmingly, . % have no dental insurance benefits ( ) . the fiscal solvency of dental safety-net clinics will thus remain critical to serving at-risk populations during and after the pandemic. these sites will be needed more than ever, as delayed and postponed treatment increases need for more extensive and urgent care. it is widely documented that during economic downturns, medicaid enrollment increases ( ) . with unemployment increasing at an unprecedented rate, we can reasonably anticipate the same effect in this pandemic. during times of state budget cuts, dental medicaid coverage is often at risk ( ) . in the immediate aftermath of the great recession during state fiscal years through , states reported restrictions in medicaid adult dental benefits ( ) . amidst the pandemic, many states have modified public payment policies to meet the demand of their most vulnerable residents, and it will be important that advocacy efforts secure continuity of these provisional changes. however, given current circumstances, it is imperative that policy makers consider expanding adult dental benefits under medicaid rather than reducing them. access disparities will likely increase without expansion of dental benefits under medicaid. guidance for dental practice during covid- continues to evolve, and regulations vary by state ( ) . as dental care resumes, it is critical that workforce policies and licensure scope are evaluated to address workforce utilization bottlenecks to respond to communities' needs more effectively and efficiently. as of , states did not allow for some form of direct access to preventive oral health services by a dental team member outside of the dentist's supervision ( ) . in these states, a dentist must perform an examination before delivery of preventive care by a hygienist. easing scope of practice and workforce restrictions would increase access to care. increasing opportunities for dental preventing chronic disease team members like dental therapists, community dental health coordinators, and expanded function dental assistants -all currently in limited supply and restricted by dental practice acts in many states -would help bring needed, more affordable services to underserved communities. the covid- pandemic has thrust alternative modalities such as teledentistry to the forefront of policy considerations ( ) . teledentistry supports the delivery of oral health services through electronic communication means, connecting providers and patients without usual time and space constraints. teledentistry's unique ability to connect disadvantaged, primarily rural communities and the homebound with dental providers ( ) makes this method particularly well-suited to address lack of access during and after the pandemic. teledentistry can be used for education, consultation, and triage, allowing providers to advise patients whether their dental concerns constitute a need for urgent or emergency care, whether a condition could be temporarily alleviated at home, or whether treatment could be postponed. when many dental offices are closed and people are largely staying at home, communication and information via teledentistry can help lessen the burden of people seeking dental care at overwhelmed emergency departments and urgent dental care settings. in more usual circumstances, teledentistry can also be used to facilitate access to preventive services and oral health education when members of the dental team can provide such services in community settings, such as schools, without onsite dentist supervision. before covid- , many states inhibited use of teledentistry through legislative barriers and limited public and private insurance reimbursement. compared with dentistry, many medical and behavioral health providers have less restrictive regulations and insurance reimbursement policies concerning telehealth. a washington post report ( ) was clear: "telemedicine was largely ready for the influx." teledentistry, on the other hand, was forced to play catch-up ( ) . emergency reimbursement changes prompted by covid- have brought relief, but post-pandemic, we recommend that legislators, regulatory authorities, and third-party payers consider making permanent the temporary modifications to teledentistry policies to support increased access. health inequities are avoidable and unjust. although sars-cov- has infected people worldwide, it has disproportionately affected those who are most disadvantaged. in the united states, people without good access to health care, healthy food, and a safe environment; with underlying health conditions; who live in crowded conditions; or who have become unemployed and homeless are especially vulnerable and at increased exposure to the virus. it is time to recognize the social determinants of health and rectify unjust conditions, systemic inequality, and racism. oral health disparities and inequities are part of the larger, cultural picture. there has been a tendency to blame the victim. mary otto, health journalist and author of the groundbreaking book teeth ( ), stated, "we see tooth decay through a moral lens, almost. we judge people who have oral disease as moral failures, rather than people who are suffering from a disease" ( ). it is perhaps not hyperbole to describe pandemic-related circumstances as creating a "perfect storm" in oral health care in the united states. risk factors are elevated, access for the most vulnerable is limited, safety concerns are heightened, and the economy presents substantial challenges for patients and providers alike. the effects of covid- are particularly acute for vulnerable populations, and the crisis has made evident the challenges and opportunities for oral health care in the united states. in such a time, oral health care providers and advocates must clearly communicate the importance of oral health to overall health, indicate the steps being taken to ensure patient and provider safety, and promote prevention and nonaerosolizing procedures ( table ) . oral health should be included in policy considerations, continued research, monitoring, surveillance, and other aspects of health. advocacy is crucial to make permanent the temporary regulatory changes being implemented to address the immediate crisis, ensure access to oral health care, address disparities and inequities, and improve population health. world health organization. coronavirus disease (covid- ) pandemic airborne or droplet precautions for health workers treating covid- ? american dental association. ada recommending dentists postpone elective procedures american dental association. hpi poll examines impact of covid- on dental practices as some states consider reopening, ada offers ppe guidance to dentists oral health in america: a report of the surgeon general prevention and control of dental caries and periodontal diseases at individual and population level: consensus report of group of joint efp/orca workshop on the boundaries between caries and periodontal diseases the healthy eating index and coronal dental caries in us adults: national health and nutrition examination survey - periodontitis in us adults: national health and nutrition examination survey - covidview: a weekly surveillance summary of us covid- activity table : percentage of dentate adults aged - with untreated tooth decay in permanent teeth spotlight: racial and ethnic disparities in heart disease integrating the common risk factor approach into a social determinants framework committee on oral health access to services. improving access to oral health care for vulnerable and underserved populations centers for disease control and prevention. covid- in racial and ethnic minority groups need-extra-precautions/people-withmedical-conditions.html?cdc_aa_ refval=https% a% f% fwww.cdc.gov% fcoronavirus% f -ncov% fneed-extra-precautions% fgroups-at-higherrisk.html periodontitis and systemic disease: association or causality? curr oral health rep periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis no mental health without oral health integration of oral health and primary care: communication, coordination, and referral. discussion paper guidance for dental settings access to oral health care: a national crisis and call to reform where are all the patients? addressing covid- fear to encourage sick patients to seek emergency care school dentalsealant programs could prevent most cavities, lower treatment costs in vulnerable children vital signs: dental sealant use and untreated tooth decay among u.s. school-aged children disparities in access to oral health care guidelines for infection control in dental health-care settings - the workers who face the greatest coronavirus risk. the new york times occupational safety and health administration. dentistry workers and employers aerosols and splatter in dentistry: a brief review of the literature and infection control implications possible aerosol transmission of covid- and special precautions in dentistry american dental association. ada fluoridation policy american dental hygienists' association. standards for clinical dental hygiene practice white paper on dental caries prevention and management. a summary of the current evidence and key issues in controlling this preventable disease delivering better oral health: an evidence-based toolkit for prevention evidence-based clinical practice guideline on nonrestorative treatments for carious lesions: a report from the american dental association nonrestorative treatments for caries: systematic review and network meta-analysis assessment of paediatric dental guidelines and caries management alternatives in the post covid- period. a critical review and clinical recommendations model for taking care of patients with early childhood caries during the sars-cov- pandemic prevention in practice-a summary dental caries risk communication and community engagement readiness and response to coronavirus disease (covid- ): interim guidance medicaid adult dental benefits: an overview medicaid access during economic distress: lessons learned from the great recession do medicaid benefit expansions have teeth? the effect of medicaid adult dental coverage on the use of dental services and oral health trends in state medicaid programs: looking back and looking ahead covid- state mandates and recommendations variation in dental hygiene scope of practice by state covid- puts teledentistry in the spotlight applications of teledentistry: a literature review and update telemedicine keeps doctors and patients connected at a safe remove. the washington post teledentistry beyond covid- : applications for private practice teeth: the story of beauty, inequality, and the struggle for oral health in america why dentistry is separate from medicine: the divide sometimes has devastating consequences.the atlantic the authors received no financial support for this work. the findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the centers for disease control and prevention. no borrowed material, copyrighted surveys, instruments, or tools were used for this article. key: cord- - m xkbok authors: testa, alexander; santos, mateus rennó; weiss, douglas b. title: incarceration rates and hospital beds per capita: a cross-national study of countries, - date: - - journal: soc sci med doi: . /j.socscimed. . sha: doc_id: cord_uid: m xkbok rationale. incarceration carries several negative ramifications for population health, while diverting scarce resources from other public goods. at a time when health care systems around the world are strained, the current study investigates the long-term relationship between incarceration and health care infrastructure. objective. we investigated the longitudinal association between incarceration rates and hospital beds per capita for countries between - . method. fixed effects regression analyses were employed to examine the effect of within-country changes in incarceration rates on hospital beds per capita. results. findings demonstrated that increases in national incarceration rates over time were associated with declines in hospital beds per capita, net of controls for socio-demographic and economic factors. conclusions. increased incarceration negatively impacts hospital bed availability at the cross-national level. a growing body of research documents that incarceration carries negative ramifications for population health (blankenship et al., ; jahn et al., ; stuckler et al., ; testa et al., ; weidner & schultz, ; wildeman, ; wildeman & wang, ) and shows increased incarceration has spillover effects that negatively impact other institutions including labor markets (western & beckett, ) and political institutions (uggen & manza, ) . while the influence of incarceration on population health and other social institutions has received considerable attention, less research has focused on how incarceration effects the wider functioning of health care systems (schnittker et al., ) . even so, previous research has drawn attention to this issue, noting, "consideration of the [impact on the] health care system is essential to evaluating the total social costs of incarceration" (schnittker et al., : p. ). this consideration is particularly relevant in light of the covid- pandemic, which has increased awareness of the spread of infectious diseases within correctional institutions (rubin, ) , and the capacity of hospital and health care infrastructure worldwide (cavalo et al., ) . thus far, existing research has focused on the relationship between incarceration and a single measure of health care infrastructure: psychiatric hospitalization (kim, ) . this line of research stems from penrose's ( ) hypothesis and subsequent observation of an inverse relationship between prison populations and psychiatric bed capacity in european countries. this hypothesis received increased attention during the latter half of the th century as many countries began undergoing a period of psychiatric deinstitutionalization (mundt, ) . while this relationship has been observed in other parts of the world including south america (mundt et al., ) and the united states (harcourt, ) , there are a variety of issues surrounding data and methodology that prevent any firm conclusions from being made in regard to the penrose hypothesis (kalapos, ; kim, ; mundt, ) . the focus on psychiatric hospitalization leaves open the question of whether the inverse relationship between incarceration and health care infrastructure extends beyond that of mental health care capacity alone. the exclusive focus on the tradeoff in the relationship between incarceration and psychiatric hospitalization neglects the possibility that investment in social control via incarceration may be offset by broader reductions in health care infrastructure across public, private, general, and specialized hospitals (schnittker et al., ) . indeed, one plausible hypothesis is that the inverse relationship between incarceration and psychiatric hospitalization is that it is just one reflection of the broader extent to which a society emphasizes social support relative to social control (cullen, ) . that is, increased emphasis on social control through incarceration will be associated with broader reductions in social support that extend beyond just psychiatric hospitalization and negatively impact other forms of social support including general health care infrastructure. according to prior research, countries that emphasize greater social support expenditures are likely to be characterized by a stronger emphasis on investing in public health (papanicolas et al., ) and less investment in institutions of social control such as incarceration (sutton, ) . at the same time, greater investment in social control via incarceration may be offset by reduced investment in the broader health care infrastructure. as one example, schnittker and colleagues ( ) found that u.s. states with a higher percentage of former prisoners have a weaker health care infrastructure characterized by a higher percentage of uninsured residents and higher rates of emergency room visitations. however, extant research has only begun to consider the general relationship between incarceration and health care infrastructure. existing research that has examined this relationship has largely been conducted at sub-national levels within the united states. wildeman ( : p. ) notes that "virtually all existing research on the macro-level consequences of incarceration has to date focused solely on the united states … which is problematic because there are several reasons to expect changes in the incarceration rate in the united states and in other developed democracies to yield qualitatively different results." indeed, incarceration rates vary substantially across countries, with the united states being particularly unique in this regard having an especially steep rise incarceration rate between the s and s relative to other countries (travis et al., ) . in this study, we use longitudinal data for a sample of countries from - to assess the longitudinal relationship between incarceration and health care infrastructure. specifically, we address the following research question: data for this study were compiled from a variety of international organizations including the world health organization (who), united nations (un), and world bank. the study was restricted to countries with available data beginning during the s and s -a key phase in the buildup of incarceration in many countries (walmsley, ) . because several variables used in the analysis were not collected every year, we used a five-year average of variables which is a common practice in cross-national incarceration research (weiss et al., ) . the final analytic sample is comprised of nine (t) -year waves ( - , - , - , - , - , - , - , - , - ) for (n) countries resulting in a sample size of country-waves (n x t). appendix a details the sample selection process and appendix b provides the countries and years included in the sample. hospital bed rate measures the number of inpatient beds available in public, private, general, and specialized hospitals and rehabilitation centers, including both acute and chronic care per , population. hospital bed data are compiled by the who and are supplemented by the world bank. hospital beds are a key measure of health care infrastructure as they indicate the availability of inpatient services in each country. the hospital bed rate is transformed using the natural logarithm to account for the positive skew. incarceration rate measures the average number of incarcerated persons in prison and jail per , population. incarceration rates are collected from the world prison brief, which is hosted by the institute for crime & justice policy research (walmsley, ) . incarceration rates are based on national government statistics, as well as other official sources. the incarceration rate is log transformed to adjust for positive skew. several control variables are included to account for relevant socio-demographic characteristics of a country. percent male represents the percentage of a country's population that is male and is obtained from the from the un world population prospects. the gini index is used to control for economic inequality and ranges from a hypothetical value of (completely equal) to (completely unequal) and is obtained from the standardized world income inequality database (swiid) (solt, ) . for analyses, we rescaled the gini index to - . to account for cross-national differences in crime, we include the homicide rate per , obtained from who mortality database. homicide rate is log transformed to account for the positive skew. to adjust for differences in the age structure of a population, we include an ordinal variable for the percentage of the population in each of five age groupings ( - [reference], - , - , - , and and older). data on age-structure were obtained from the un world population prospects. we measure the system of governance in a country using data from the polity database, which produces a -point scale (- to + ) (marshall & jaggers, ) . following prior research, we collapse the scale into three categories: full democracy ( points on the polity scale), transitional democracy ( - points), and autocracy (− to points) (lafree & tseloni, ) . finally, to adjust for socio-economic development, we generate a development index using four highly correlated items from the world bank: gross domestic product per capita, infant mortality rate, life expectancy, and percentage of a country's population that lives in urban areas. the development index is created using principal components analysis and is set to a standardized scale ranging from - , where higher scores equate to more socio-economic development (cronbach's α = . ; eigenvalue = . ). the longitudinal association between incarceration and hospital bed rates is assessed using fixed-effects linear regression. fixed-effects modeling assesses within-country changes in incarceration and hospital beds, while controlling for the influence of any unobserved timeinvariant measures that may confound this association. also, the observed controls account for the influence of several time-varying variables. the coefficients from fixed-effects models provide an estimate of how contemporaneous changes in incarceration rates over time correspond with changes in hospital beds per capita over time (kropko & kubinec, ) . a hausman test revealed that the fixed-effects model is a preferred estimation method compared to random-effects (χ = . , p < . ). standard errors are clustered by country to account for dependence of observations within countries (wooldridge, ) . a statistical power analysis performed using g*power . (faul, erdfelder, buchner, & lang, ) indicates adequate sample size to detect a small effect size and a . significance level for a multivariable fixedeffects regression (two-tailed test). table provides the summary statistics for the analytic sample. the mean incarceration rate is per , population and ranges from a low of . (greece; - ) to a high of . (united states; - . the average hospital bed rate is . per , population, and ranges from a low of . (venezuela; - to a high of . (finland; - . [ table here] [ figure here] table presents the results of the fixed effects regression of hospital beds per capita regressed on incarceration rates. model demonstrates that incarceration rates yield a strong negative bivariate association with hospital beds per capita (β = -. , % ci = -. , -. ). after adding the controls in model , we find that the inverse association between incarceration and hospital bed rates remains similar (β = -. , % ci = -. , -. ). substantively, the results indicate that each % increase in the incarceration rate is associated with a . % decline in hospital beds per capita. appendix c displays this inverse association: thus, a country with an incarceration rate of persons per , is predicted to have . hospital beds per , persons. however, this predicted rate falls to . hospital beds per capita for countries with an incarceration rate of per , . a robustness analysis that removed the united states from the analytic sample produced substantively similar findings (results available as an online appendix). [ table here] the global spread of covid- has drawn attention to the importance of population health, the vulnerability of prison systems across the world to the spread of infectious disease, and how under-resourced health care systems are in many countries. drawing from a growing body of research that suggests incarceration is a key social institution that impacts population health (wildeman & wang, ) , as well as a smaller body of research suggesting that incarceration may have spillover effects on healthcare (schnittker et al., ) , the current study investigated whether increases in incarceration rates within countries over time are associated with changes in the number of hospital beds per capita. results suggest that there is an inverse association between incarceration and hospital beds per capita at the country level. while this is the first study to examine the relationship between incarceration and hospital bed availability, this result is consistent with the penrose ( ) hypothesis which is specific to psychiatric hospitalization, as well as prior research on incarceration and health care infrastructure at the sub-national level in the united states (schnittker et al., ) . these findings also expand upon efforts to understand how incarceration is related to population health by suggesting that incarceration may increase the strain placed on national health care systems by contributing to adverse health outcomes while simultaneously reducing the capacity of the systems that treat these health problems. in this sense, the findings highlight broader societal consequences that result from increased incarceration. sampson ( ) previously proposed that research should evaluate the full ramifications of the benefits of incarceration (i.e. crime reduction) against any unintended and hidden costs. on this point, recent work has suggested the one fruitful avenue is "to more fully assess the incarceration ledger and the potential offsetting consequences of the prison boom for health inequalities." (light & marshall, : p. ). our study highlights the degree to which prison booms may contribute to a weakening of health care infrastructure, which in turn may generate greater vulnerabilities for population health. several limitations in the current study may be expanded upon in future research. first, the study was limited to mostly developed countries due to limitations in the availability of longitudinal data. as more longitudinal data emerge, future research can investigate the relationship between incarceration and health care infrastructure in a broader sample of both developed and developing countries. second, the current study used five-year averages and could not assess annual changes in incarceration and hospital beds per capita because data on key variables are not collected annually. third, this study focused on the impact of incarceration on hospital beds per capita only. future research can investigate the link between incarceration and other metrics of health care infrastructure such as the number of doctors per capita, the percentage of uninsured citizens, and the frequency of emergency room visitations. fourth, because detailed measures on crime rates are not available cross-nationally, we used national homicide rates to control for differences in crime. while homicide rates are considered the most reliable and available indicator of crime in a cross-national context, incarceration rates may be influenced by rates of property and violent crime beyond that of homicide. fifth, the measure of hospital beds per capita combines a variety of inpatient beds including public, private, general, and specialized hospitals. thus, we cannot disentangle the specific hospital bed types in each country. sixth, while the focus of this study was on incarceration, future research could explore other measures of punitiveness, such as the number of police, the use of alternative punishments aside from incarceration, and the prevalence of capital punishment. finally, the current study offers insufficient evidence of a trade-off between investment in incarceration and health care infrastructure as countries have numerous budgetary considerations in any given year, which were not fully accounted for, including national infrastructure investment, social welfare programs, and national security. the covid- pandemic highlights challenges in the tradeoff between investment in public goods including public health and public safety. as the effects of the virus strain the existing resources of national health care systems by requiring high levels of hospitalization, large populations in jails and prisons can contribute to the further spread of contagions while placing an even greater strain on existing resources. countries should take a holistic approach to public welfare by considering the potential negative ramifications of prioritizing one public good at the expense of others. year group hospital bed rate mass incarceration, race inequality, and 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incarceration as a unique social stressor during pregnancy: implications for maternal and newborn health the growth of incarceration in the united states: exploring causes and consequences global incarceration and prison trends world prison population list. london, uk: international centre for prison studies institutional anomie and cross-national differences in incarceration examining the relationship between us incarceration rates and population health at the county level. ssm-population health incarceration and population health in wealthy democracies mass incarceration, public health, and widening inequality in the usa econometric analysis of cross section and panel data key: cord- -dkm y authors: tam, theresa w. s. title: preparing for uncertainty during public health emergencies: what canadian health leaders can do now to optimize future emergency response date: - - journal: healthc manage forum doi: . / sha: doc_id: cord_uid: dkm y it is clear that the risk for epidemics with high health and socio-economic impacts remains but there will be many unknowns at the start of future responses to these events. this article highlights principles and practices to assist health leaders in preparing for uncertainty, including integrating scalability to ensure response activities can be more easily adapted to suit evolving needs; assessing risk and capabilities to inform planning for appropriate response measures; and considering overall flexibility and adaptability of plans, systems, and resources. ultimately, being prepared for “disease x” is about applying the approaches that we have learned from previous events, using evidence-based practices to develop and strengthen foundational capacities, so that we are able to respond to the unanticipated in proportionate and appropriate ways. lessons from emerging health events, past and present, remind us that threats to human health are always present and will continue to be influenced by factors such as climate change, the human-animal interface, and international travel. however, emerging diseases come with many unknowns and even known diseases can behave in unexpected ways. during the initial preparation of this article, a novel coronavirus causing disease in humans was emerging at the humananimal interface in china. the covid- is a harsh reminder that uncertainty is part of the emergence equation and we will always be challenged to rapidly confirm the knowns and to respond as best we can, despite the unknowns. it helps to prepare with this in mind. severe acute respiratory syndrome (sars) was our first "disease x" of the st century. the world health organization recently coined this term to represent uncertainty as a critical planning element in preparedness for a serious international epidemic and specifically to encourage preparedness activities that account for uncertainty. there are many sources of uncertainty that are essentially the "who, what, when, where, why, and how" characteristics of a public health emergency. the "who" might be unexpected at-risk groups, such as persons with obesity who developed severe illness during the h n influenza pandemic. the "what" could be unexpected outcomes such as microcephaly in infants born to mothers with zika virus infection during pregnancy. the "where" could be an unexpected location for disease emergence, such as the h n pandemic influenza that began in north america, rather than asia, as had been anticipated and planned for. finally, in the event of an unknown pathogen such as sars in and now with covid- , the outbreak response must run parallel with a rapid gathering of international evidence (clinical, laboratory, epidemiological, etc), meaning that the level of uncertainty is dynamic and the response will need to be adjusted as and when we know more. the purpose of this article is to identify some basic principles for dealing with uncertainty in the context of a public health emergency, to provide some examples of how these principles in combination with past experience have advanced preparedness within the health sector in canada, and to stimulate thinking regarding what health leaders can do to further improve preparedness across the health sector in the immediate as the covid- situation unfolds and going forward in the longer term. in terms of preparedness planning, assumptions help establish a "starting point"-a direction to quickly proceed (eg, using specific established/routine practices) until a need to adjust the course is identified. they give responders an indication of what real-time data to collect, or what to watch for, to either validate the planning assumptions or signal that a change in approach is needed. for example, an assumption used in influenza pandemic planning posits that the novel influenza virus will be transmitted from person to person in the same way seasonal influenza is transmitted. healthcare providers will thus know what infection prevention and control (ipc) precautions to utilize, which builds confidence in responders when dealing with unknowns. this starting point also helps to inform how ipc measures can be scaled up or down if reality proves to be different from the planning assumption. therefore, assumptions are a foundational component for the development of preparedness and response plans and essential for incorporating flexibility. in the emergency preparedness and response context, scalability is used to convey the need for response activities to be dynamic. to manage demands and risks by scaling up (eg, adding more resources, enhancing active surveillance activities) or scaling down when there is evidence to indicate that specific response actions are no longer needed to achieve response objectives. a key lesson learned from past responses is that uncertainty and/or risk aversion can lead to overcompensation during a response (eg, inappropriate use of limited resources, responder burnout, or angst when trying to de-escalate). overcompensation can be avoided by ensuring there is sufficient content in guidance, plans, and emergency exercises to demonstrate how and when the response will be scaled up or down based on risk assessments and specific data analyses that build confidence and reduce risk aversion. another key principle involves taking a risk management approach to preparedness and response by conducting risk and capability assessments, to inform planning and response measures, and to identify gaps or enhancements that need to be addressed. specifically, this involves making an assessment of current resources available to mitigate and respond to the risk. assumptions can be used as a starting point to create scenarios against which risks and capabilities can be identified and assessed. for example, a planning scenario might include a person who presents to the emergency department complaining of nausea, weakness, and fever. to prepare for uncertainty, planners must consider variables in the scenario. for example, if this person had recently returned from a country with an ongoing ebola outbreak, would the existing triage system be sufficient to identify, assess, and rapidly contain a possible ebola case? this type of assessment helps identify specific risks, such as not including ebola in the intake differential diagnosis for ill travellers returning from an affected area. likewise, scenarios can facilitate a discussion regarding what capabilities are currently in place to mitigate this risk. however, it is also important to identify what might change the risk profile in the scenario. for example, the toronto sars case that triggered the first hospital-based outbreak was initially missed because they had no travel history. it was only learned later that the patient had been exposed to the true index case, who did have a significant travel history but was not seen in a healthcare setting. , this flagged a gap in our risk mitigation-that the capability to rapidly identify, and therefore contain, a sars case that had no travel history was lacking. to close this gap, triage questions also needed to include questions about close contact with an ill traveller. unfortunately, not all risks can be accounted for so it is important to consider what unknowns might significantly impact a risk and what planning can be done to account for them. emergency planners with expertise in risk and capability assessment need to work with healthcare leaders to determine how changes to risk levels will be addressed in real time, when to change course, and whether the capabilities are in place to deal with the requirements of the "new course." public health preparedness efforts have been largely based on previous infectious disease outbreaks, models, and scenarios. it is important to consider the flexibility and adaptability of current plans, systems, and resources when preparing for any health emergency; this is a key principle in "all-hazard" emergency preparedness. the preparedness efforts and response resources that have been developed and used for infectious disease outbreaks are now being utilized for other public health threats. borne out of the sars and h n experience, new federal/provincial/territorial governance structures were established to oversee the overall public health response. these governance structures have in turn been leveraged to respond to non-infectious disease national response, including most recently for the national epidemic of opioid-related deaths in canada. adaptable response systems are agile enough to incorporate learnings in real time and make adjustments to response activities through feedback loops. such systems can quickly establish new inter-sectoral connections to meet immediate specific response needs while increasing general response capabilities. specifically, the urgency of the opioid crisis led to the mobilization of new and pooled resources that ultimately established a timely surveillance and reporting network with coroners and medical examiners. built on an infectious disease outbreak response model, this network can potentially be leveraged for rapid mortality surveillance for emerging health events beyond opioids. there are also international efforts underway to invest in platform technologies for vaccines and therapeutics that can be adapted to target new pathogens once they are identified. utilizing sustainable, flexible governance structures and resources ensures the response system is well exercised and able to adapt to uncertainties, while supporting readiness for other health threats and emergencies. the idea of identifying "lessons learned" after the conclusion of an emergency response is also a key principle of preparedness for future events. the challenge for health leaders is to ensure that the lessons identified actually translate to better understanding and ultimately an improved ability to respond. importantly, this process has to ensure that learnings are not forgotten during peacetime or lost over time with staff turnover. the importance of risk communication, building and maintaining public trust and confidence, and cross health sector engagement are just a few of the key lessons that have been identified from past emergency responses. the covid- response is now showing us in real time the growing role of the internet and social media in risk communication. early, frequent communication of uncertainties is vital to building and maintaining public trust and confidence. we have learned that perception is reality and that being transparent in risk communication is essential. this means it is vital for health leaders to be forthcoming from the outset, clearly stating what we know and what we do not know, while reassuring the public that we will provide new information as and when we know it. despite the relatively limited spread of sars in canada, it served to highlight the importance of supporting and maintaining cross health sector preparedness for a seamless and comprehensive health response. this starts with increasing the number of astute frontline practitioners who are sensitized and equipped to practice "think, tell, test." this means the first line of defence is primed to think about the possibility of an emerging pathogen, promptly tell local public health authorities, and efficiently work with clinical colleagues, hospital administrators, public health, and laboratory partners to ensure early detection and rapid containment through appropriate and timely testing. continuing to build and maintain a skilled and engaged workforce is essential to a robust and flexible response system. health leaders can ensure that the lessons learned from past experiences are passed on through regular training and exercises to those entering or taking on new roles within the workforce. engaging across the health sector on a regular basis, in order to re-confirm roles and responsibilities, conduct joint risk and capability assessments, foster research, and provide updates on the status of preparedness activities, is also key to ensuring health sector preparedness and maintaining an ongoing state of readiness. there are operational (eg, medical evacuation and domestic transportation) and logistical (eg, supply chain and stockpiling issues) aspects of a response that require crosssectoral engagement to address, ideally in advance of an emergency. we have seen the benefit of having contracts in place, for example, for influenza pandemic vaccine supply during the h n pandemic and more recently for international medical evacuation capacity during the ebola outbreak in west africa. we have also witnessed the need for advanced preparedness to engage in real-time research to ensure the response is as evidence based as possible. this has translated into advanced planning by organizations such as the canadian institutes of health research, for example, to foster rapid ethics reviews during an emergency response and supporting the canadian immunization research network to conduct vaccine clinical trials in real time. extending the health sector preparedness to include other sectors/disciplines (eg, social services, critical infrastructure, regulatory authorities, public safety, justice) is critical to a seamless response. engaging communities and considering their contexts, culture, and perspectives in the preparedness for public health events is essential to the building of trust and public cooperation with health authorities during a response. post-sars, emergency management practices have been adopted more widely by the health system in canada. there is also a greater recognition of the significant social and economic impacts of public health emergencies and the importance of mitigating these impacts through mechanisms that enhance capabilities. health leaders would be wise to ensure that emergency management, multi-sectoral coordination, and mutual aid capabilities are well integrated and exercised within their institutional response planning. health facilities must also develop and practice their business continuity plan as a complement to their pandemic plan, given that the health of the workforce may be significantly impacted while workload demand is high. the public health agency of canada, established following sars as the national coordinating body for health emergencies, has made significant investments in order to increase emergency preparedness and response capacity in canada, build on the lessons learned from past experiences, and facilitate cross-sector preparedness and resiliency. this work has been multi-focal, ranging from the production and updating of plans, protocols, and technical guidance to conducting training, stockpiling vaccines, and therapeutics, to running exercises to test current knowledge and capabilities. many of these efforts are intended to increase the level of preparedness across the breadth of the healthcare sector, not just public health, and not just for emergencies originating in canada. examples include enhancing public health laboratory and border screening capacity; establishing mutual aid and information sharing agreements ; and clarifying roles, responsibilities, and procedures (eg, how to request and receive aid and emergency provisions) during emergencies. canada has met the international health regulations core capacity requirements and was ranked th in the world in the global health security index, assessing global health security and capabilities. although there is a strong existing system in place, ongoing work is still needed to achieve a state of flexible and scalable readiness for the next public health emergency. as we begin a new decade, we must maintain constant vigilance as epidemics are predicted to become more frequent, more complex, and harder to prevent and contain. health leaders need to prepare for uncertainty during an emergency response by developing, enhancing, and exercising resources-whether it be plans, people, or other resources-that can be flexible, scalable, and that are built on lessons learned and evidence-based practices. health leaders are well poised to see gaps and reflect on persistent challenges and recurring themes, while looking beyond their scope of influence to find creative solutions. working from the ground up, health leaders should train staff in emergency management principles, share corporate memory, incorporate lessons learned, and build confidence through regular exercises. exercises and training should consider the response to complex health emergencies, including pandemics, which are rapidly evolving and may last many months. health leaders should also consider engaging with health professional regulatory bodies to explore whether and how regulatory requirements might be adapted, streamlined, or otherwise expedited during an emergency. finally, staff must be encouraged to contribute to contingency planning by identifying concerns and repositioning them as uncertainties to be addressed. although it can be difficult to convince decision-makers to invest upstream in non-specific emergency preparedness resources, it is important to present the downstream benefits including risk reduction, medium-to long-term cost savings, and operational resilience. one means of fostering support is to build the understanding that investment of time, energy, and resources can pay off during normal operations, not just during large-scale health emergencies. emergency planning can help ensure business continuity whenever there is an unexpected surge in resource demands against the backdrop of everlimited, finite supplies. finally, recognize that the opportunity to address critical gaps is never more urgent than during an emergency. every event is an opportunity, given heightened political attention and investment in health capacity during a crisis. we need to build on these gains to both improve routine practice and better prepare us for future response. throughout this call to action to strengthen health security, i would urge health leaders to integrate a health equity lens and seek meaningful engagement from the communities they serve in order to build trust and enable a collaborative and effective response during times of uncertainty. the covid- is the latest "disease x" but it will not be the last. health leaders, now more than ever, need to gather new knowledge, adapt response activities, and meaningfully engage with all partners across government, research, and the public at large to respond, as flexibly and effectively as possible, to this new health threat in canada and around the world. available at: https:// www.who.int/activities/prioritizing-diseases-for-research-anddevelopment-in-emergency-contexts risk factors for severe outcomes following influenza a (h n ) infection: a global pooled analysis world health organization. zika epidemiology update lessons learned review: public health agency of canada and health canada response to the h n pandemic sars: lessons learned from toronto severe acute respiratory syndrome (sars): a year in review canadian pandemic influenza preparedness: planning guidance for the health sector fifteen years post-sars: key milestones in canada's public health emergency response covid public health emergency of international concern (pheic) global research and innovation forum: towards a research roadmap multi-lateral information sharing agreement (mlisa) joint external evaluation of ihr core capacities of canada mission report global health security index: building collective action and accountability the author would like to thank jill sciberras, jeannette macey, and teresa leung for their assistance in preparing this manuscript. theresa w. s. tam, bmbs (uk), frcpc https://orcid.org/ - - - key: cord- - h qxcg authors: kennelly, brendan; o'callaghan, mike; coughlan, diarmuid; cullinan, john; doherty, edel; glynn, liam; moloney, eoin; queally, michelle title: the covid- pandemic in ireland: an overview of the health service and economic policy response date: - - journal: health policy technol doi: . /j.hlpt. . . sha: doc_id: cord_uid: h qxcg objectives: to outline the situation in ireland with regard to the covid- pandemic methods: analyse the evolution of the covid- pandemic in ireland. review the key public health and health system responses. results: over , people have died with covid- by july (th) while almost , people had been admitted to hospital with covid- . a high proportion of the deaths occurred in nursing homes and other residential centres who did not receive sufficient attention during the early phase of the pandemic. conclusions: ireland's response to the covid- crisis has been comprehensive and timely. transparency, a commitment to a relatively open data policy, the use of traditional and social media to inform the population, and the frequency of updates from the department of health and the health services executive are all commendable and have led to a high level of compliance among the general public with the various non-medical measures introduced by the government. this paper outlines the situation in ireland with regard to the covid- pandemic. we begin by outlining some key indicators of population health in ireland and a brief description of the health system. we then discuss the key health policy and health technology aspects of the pandemic in ireland. we analyse the available data on cases, hospitalisations and deaths, and outline the key public health initiatives undertaken by the government in ireland. our data analysis covers the period from february when the first case was reported up to july . the response of the health system is explored in detail. we also discuss the economic impact of the virus to date and outline the very substantial financial measures that have been implemented by the government to ameliorate some of the effects of the pandemic, and the related lockdown, on individuals and businesses. the final section contains suggestions for how the country may cope with the continuing presence of the virus. according to the most recent census there were , , people classified as usually resident in ireland in . the central statistics office (cso) estimates that the population increased by . % since then . the breakdown of the estimates by region and age group is contained in table . there is a heavy concentration of the population in dublin and the mid-east region that surrounds dublin, with over % of the population living in that area. overall, the population density is people per square kilometre. the proportion of the population aged or older is a little over % while the proportion aged over is just over . %. almost , people ( . % of the total population) lived alone in and, of these, % were aged or older. just over % of the population aged + were single while . % of this age group were married. there were almost , one-parent families in , % of which were headed by a female . there were , people with at least one disability living in a communal establishment in . almost % of these were aged or older. there were approximately , homeless people in ireland at the beginning of , most of whom were living in temporary accommodation. around , people seeking asylum in ireland were living in direct provision centres at the end of , with a further , living in emergency accommodation centres. there were almost , members of the traveller community in ireland in . . % of the population in were born outside of ireland, mainly elsewhere in europe . health policy in ireland is determined by the department of health, headed by a minister of health, and publicly funded healthcare is delivered by the health services executive (hse). there is also substantial private sector involvement in the delivery of healthcare, ranging from gps to allied healthcare professionals to private hospitals. the irish health system incorporates public, voluntary and private elements in the production, delivery and financing of healthcare. people in category i (which includes % of the population) are eligible for free healthcare in the public system (with significant copayments for medicines). most people who qualify for category i entitlements do so on the basis of a means test while others do so depending on a diagnosis of a specified chronic illness. a further % of the population have a limited form of eligibility in category which entitles them to free gp visits . the remainder of the population are in category ii, which entitles them to care in the public hospital system subject to a co-payment. they pay a full fee for visits to a gp. many people in category ii as well as a minority of people in category i buy private health insurance which gives them access to privately supplied care, some of which is provided in private hospitals but much of it is provided in public hospitals. approximately % of healthcare expenditure is funded by taxation, % by private health insurance and the remaining % of expenditure by out-of-pocket payments. further details about the irish health system and proposals to reform it can be found in connolly and wren , cullinan et al and burke et al . the cso recommends that modified gross national income be used as a measure of overall economic activity rather than gross domestic product (gdp) because of the disproportionate effect of globalisation on irish gdp. the proportion of modified gross national income that is spent on healthcare in ireland was % in . per capita expenditure on health (adjusted for purchasing power parities) was estimated to be $ , in . the number of practicing doctors in ireland is . per , , a relatively low figure by international standards. the number of nurses, . per , , is higher than the average in the oecd. there were a total of just over , hospital doctors in ireland in september , % of whom were consultants. there were . hospital beds per , inhabitants in ireland in . a particular concern at the beginning of the pandemic was the low number of icu beds in ireland. the total number of icu beds in the public health system was estimated to be in february or . icu beds per , people. long-term residential care in ireland is provided by publicly-owned, privately-owned and voluntary (not-for-profit) care homes. there are approximately , people living in nursing homes run by private and voluntary organisations and a further , people living in public nursing homes. pearce et al estimated that a significant proportion (between one half and two thirds) of nursing home residents have dementia. the national public health emergency team (nphet), a body of approximately medical, science and health service professionals, was activated in january to deal with the covid- . its chairman is the state's chief medical officer, dr. tony holohan. nphet is supported by an expert advisory group as well as sub-groups, including an expert modelling group. nphet works closely with the hse national crisis management team which manages the hse's response. questions have been raised in dáil Éireann (the irish parliament) about the membership of nphet and the delay in minutes of meetings being released. the department of the taoiseach (prime minster) has given regular press briefings since march th . these typically include details of financial supports for individuals and businesses. in may, a special parliamentary committee was established to consider the state's response to the pandemic. the committee has been meeting weekly and its proceedings are streamed live. there are four publicly available official online data sources relating to ireland . these bulletins contain data not previously available, such as a breakdown of deaths by county. since april th , the hse has released daily updates describing the acute hospital activity related to covid- . these updates offer a succinct summary of the situation in each of ireland's public hospitals and critical care units in relation to covid- . current covid- admissions, occupancy due to covid- and non-covid disease, and available bed capacity in terms of regular beds and critical care beds are all included in these updates. individual hospitals are listed by name and this offers some additional visibility on where in the country covid- is most active. our data analysis covers the period from february , when the first case was reported, up to july . from the outset, cases were defined as people who had tested positive for covid- . despite initial ambitious plans by the hse to test widely, it became clear quite quickly that laboratory capacity could not meet the demand created by the broad definition of criteria for testing. gps quickly identified thousands of patients with respiratory symptoms as part of the first wave of the covid- pandemic. these patients were referred for testing before the capacity existed to either conduct or to analyse this level of testing in a timely fashion, which meant there were considerable delays in the system. testing criteria were changed on march th . the new criteria stated that individuals must be suffering from two symptoms, have a respiratory disease, and be a contact of a confirmed or suspected case, and also be in a priority group to be eligible for testing. some testing was outsourced to german laboratories to clear the backlog. these outsourced test results were delayed coming back into the system which created a -day period in mid-april where these test results were returned in bulk and reported in the daily hpsc and doh updates. this led to a spike in apparent virus activity which was, in fact, an artefact of the delays. initially, for a death to be classified as a covid- death, it was contingent on the patient having a laboratory-confirmed diagnosis of covid- before their death. since april th , the hpsc have included 'probable' deaths (i.e. deaths where the cause was likely covid- but where the patient was not tested before death) in the total deaths tally. deaths include people who died in either private homes or long term residential institutions in the community as well as people who died in hospital. this complete tally of hospital patients, community patients and probable cases has remained the standard reporting format since april th . the majority of cases in ireland have been in the east of the country, with % of cases occurring in dublin. more broadly, a block of ten counties in the east, north-east and midlands, account for almost % of the total number of cases (see figure ). initially, most cases had a history of foreign travel, most notably to northern italy, but by the end of april community transmission accounted for almost two-thirds of total cases. figure shows the number of new cases each day. the peak of new cases occurred in mid-april. however, positive covid- results returning in bulk from foreign laboratories around this time complicates this somewhat, as date of reporting lagged significantly behind date of sampling. while the large majority of cases recovered without needing to be hospitalised, . % of cases did require hospitalisation while . % of cases were admitted to icu . reporting of cumulative covid- deaths also rose sharply on april nd (see figure ). this is due to the fact that at this point the hpsc and doh began reporting the initial focus in ireland was on how the virus was spreading in the general community, but by the end of march it was clear that the virus has spread widely in a substantial number of long-term residential settings. there have been clusters (defined as or more cases) in nursing homes and clusters in other residential settings. nursing homes and residential settings in the east and north-east have been especially vulnerable, with % of the clusters in long-term residential settings occurring in these areas. healthcare workers in ireland have also been disproportionately affected by covid- , with % of cases being detected in healthcare staff . the hse daily operations update offers the most granular breakdown of hospital activity related to covid- , particularly critical care activity. it includes the measure "total critical care beds open & staffed", which is arguably a more important measure than ventilator availability. no figures are available as to the number of people isolating at home. this may become a more relevant measure as society-wide restrictions are relaxed and more focused efforts are employed to control covid- activity. initially, the number of new cases grew rapidly and increases exceeded % on some days. the public health restrictions imposed by the government and the high level of compliance with these restrictions and general public health advice slowed the spread of the virus very significantly. on april th , the daily increase in cases fell below %, and dropped sharply thereafter, falling below % growth consistently since mid-may. similar trends can be seen of people who died were aged or older even though this group only accounted for . % of cases. males make up % of cases while they account for % of deaths. figure shows the distribution of deaths by county as of july rd . the distribution of deaths closely matches the distribution of cases with a large proportion of deaths occurring in the northeast and east of the country. information on the presence of co-morbidities is available for about % of cases and % of deaths. as of june th , % of patients who have died from covid- had chronic heart disease, % suffered from a chronic neurological condition and % had a chronic respiratory disease. the cso has analysed the spatial distribution of standard mortality rates according to the deprivation level of the area that the person who died was normally resident in . the analysis was carried out using deprivation indexes for small areas. nationally, standard mortality rates have been highest in the least deprived quintile and second highest in the most deprived quintile. so far, no individual-level analysis of the socio-economic background of people who have died has been possible as the data has not been released. , of the , ( %) cases relate to healthcare workers. of the , healthcare workers infected up to may th , % got the virus in a healthcare setting, % got the virus from contact with a confirmed case, % got the virus from travel, % got the virus from community transmission and % got the virus from a healthcare setting as a patient. seven healthcare workers have died from the virus. over a third of the healthcare workers infected by the end of april were nurses while almost a quarter were healthcare assistants . ireland has followed a multi-faceted approach to the covid- crisis involving measures to: ) limit the spread of the virus in the community and specific institutional settings, ) test and trace suspected contacts, ) ensure that there were adequate healthcare services and equipment available for people who became seriously ill with the virus, and ) limit the financial burden on individuals and businesses due to the response to the virus. extensive use of a large number of health and non-health technologies have been employed including diagnostic testing and the use of medical devices. in the period immediately after the first cases were reported in ireland, the government and the public health authorities tried to delay as much as possible the disease (this period is known as the 'delay phase'). approximately one month after the first case, the government and the public health authorities moved to the 'mitigation phase' where the main goal was to contain as much as possible the health and economic impact of the pandemic. from the outset, public health advice from the government and the hse to the community at large has emphasised frequent hand-washing, appropriate respiratory etiquette (recommending that people cover their mouth and nose with a tissue or sleeve when coughing or sneezing), the importance of maintaining a two metre distance between people, and the need to avoid touching one's eyes, nose and mouth . more recently, the importance of wearing face coverings on public transport and in indoor settings has been emphasised. traditional and social media have been extensively used to convey basic public health messages. table on march th the government introduced a second raft of mandatory measures. these included the closure of non-essential businesses such as retail outlets, gyms, hairdressers, outdoor markets and libraries while hotels were limited to cater for essential non-social and non-tourist guests. cafés and restaurants were only permitted to supply take-away food and delivery. all indoor and outdoor sporting activities were cancelled. all playgrounds were closed and places of worship were required to restrict numbers and adhere to physical distancing. essential services (such as supermarkets) were required to implement physical distancing. individuals were not permitted to take unnecessary travel either within ireland or overseas. physical distancing was required when outside and social gatherings of more than four individuals were prohibited (except for members of the same household). individuals were required to work from home unless they worked in essential services. on march th ireland moved to the mitigation phase and introduced a third range of additional measures . people were asked to stay at home unless to undertake essential work or access essential services. exercise and travel were restricted to kilometres of an individual's home and individuals were not permitted to arrange gatherings with anyone outside their households. the government issued cocooning guidelines for anyone over or medically vulnerable, asking them not to leave their houses. to ease the burden of cocooning, a community call initiative was introduced on april nd to mobilise volunteers to help cocooning citizens. to enhance compliance with the measures, an garda síochána (the irish police service) was given additional powers including arrest without warrant. non-compliance with a direction of a garda without a lawful excuse is considered a criminal offence and is punishable by a fine of up to € , , up to six months imprisonment, or a combination of both. the government also had the power to detain a person who refuses to remain in a specific place (such as a home or a hospital) if they are deemed by a medical professional to be a potential source of infection and/or a risk to public health, and detention is necessary to slow the spread of covid- . as of july st , people had been arrested for breaching the restrictions . on may st the taoiseach announced a roadmap to reopen the economy and society . initially, the roadmap contained a five phase reopening process with the first phase beginning on may th and the final phase on th august with three week periods between phases. on june th , the government announced an accelerated re-opening with a four phase process rather than five phases and with the final phase scheduled to begin on july th . an additional acceleration of the re-opening was announced on june th which meant that most commercial activity was able to resume in some form or other from june th . however, on july th , the government announced that the final (fourth) phase of re-opening would not in fact begin until august th . details of what are included in the phases of the roadmap are included in table . technology has played a major role in ireland's response to the pandemic. in the health sector, diagnostic testing, clinical trials, use of medical devices and ehealth systems have all been employed to combat the effects of the pandemic. as the pandemic progressed, the use of technology has evolved. a number of irish organisations have provided rapid evidence reviews of health technology assessment and health queries about the coronavirus and covid- disease including the national health library and knowledge service , the health information and quality authority (hiqa) , ihealthfacts and cochrane ireland . during the first month of the crisis, around , public service workers received training in contact tracing. many of these have been deployed along with existing hse staff in a series of contact tracing centres that have been set up countrywide. a special mobile phone app to track and trace covid- infections was developed by a collaboration between the private sector and health authorities and was launched on july th . over % of the population downloaded the app in the week after it was launched . a recurring concern in ireland has been the availability of personal protective equipment (ppe), which is a particular issue in long-term residential care homes. the health research board have funded local projects that avail of technology such as ai-enabled analysis and participation in international consortium clinical trials treating covid- in icu . as noted earlier, the low number of icu beds in the public health system ( in total or . per , ) was a particularly pressing issue in ireland at the beginning of the pandemic. on march th , the government announced that private hospitals had in effect been incorporated into the public hospital system for the duration of the crisis. in addition, many of the public hospitals increased the number of icu beds in their own hospitals or identified additional beds that could be used as icu beds if there was a surge in admissions. in the second week of april and has steadily declined since then. the increase in the number of icu beds meant that there were always at least icu beds available on any particular day . as far as we know, no hospital ever exceeded its icu capacity. the irish government took a number of steps to try to maintain and enhance the workforce capacity to deal with the covid- pandemic. on march th , the health service executive launched an international recruitment campaign, "be on call for ireland" to encourage healthcare professionals at home and abroad to come and work in the public health service . the number of applicants for the be on call for ireland initiative was approximately , . however, the vast majority of these were not healthcare professionals. according to the irish medical council, doctors registered with the council under this initiative. about one third of these were retired doctors returning to work. in addition to the be on call initiative, a number of other recruitment initiatives took place to maximise the current work force and increase capacity across both the public and private healthcare providers. these included increasing the hours of part time staff, maximising agency usage, rehiring of retired clinicians, redeployment of staff and encouraging those on career break to return early. the government reached an agreement in march with the private hospitals association to use its facilities for the treatment of both covid- and non covid- patients. under the deal, private hospitals essentially operated as public hospitals for a three month period. the arrangements between the state and private hospitals however did not cover consultants who work exclusively in the private sector. by april rd about one quarter of these consultants had signed up to a contract offered to them. there have been ongoing discussions around the problem of how to ensure that formerly private consultants are able to continue their care relationship with their patients with many consultants strongly criticizing the arrangement between the state and the private hospitals. the deal has been criticised over its costs (€ million cost per month) and the relatively few patients treated in these facilities . the agreement lapsed at the end of june . other actions pertaining to changing requisites in ireland include: -bringing forward exams for final year medical students to enable them to join the workforce. -all student nurses were hired as healthcare assistants. -reassignment of healthcare workers from private sector, and other external staffing supports on a needs basis. -cross training of healthcare workers where needed, for example where retraining has occurred e.g. theatre nurses to be icu nurses. individuals who suspect that they have the virus are strongly encouraged to contact their gp as the first point of contact. since mid-march, gps have been providing the majority of their consultations over the phone or via video link. a number of community hubs were established around the country. in these hubs, patients can be seen by a gp who can refer them to an acute hospital. there has been ongoing concern over people delaying seeking medical help because of fear of contracting covid- if they attended a hospital or other medical clinic . ireland has experienced considerable economic disruption from the covid- pandemic, with significant challenges for households, businesses, and policymakers. a report published on april st by the department of finance set out a macroeconomic and fiscal scenario for the period - , incorporating the potential impact of covid- . a significant contraction in modified domestic demand of . % was projected for (see table ), resulting from domestic and international efforts to combat the virus. notably, this 'baseline' projection assumed a transient shock to the irish economy, whereby activity bottoms out in the second quarter of and is followed by recovery, both domestically and internationally, later in the year. based on such a scenario, the department forecasts economic growth of % in gdp in and a restoration of overall economic activity to pre-pandemic levels in . however, it warns this is based on successful containment of the virus. in may, the economic and social research institute's forecast that real gdp would decline by over % in under a baseline scenario that reflects continued physical distancing and containment measures to the end of . from a position of full-employment at the start of , unemployment hit a record high of . % in april and is set to average . % for , with young adults disproportionately affected . at a sectoral level, non-food retail, entertainment and hospitality are among those sectors that have been hardest hit, both in terms of economic activity and employment. in terms of economic policy responses, there have been a number of measures introduced to reduce the impact on households, businesses, and the economy. broadly speaking, the government's response to the crisis at an economic level has involved attempting to reduce the impact of covid- -related restrictions on household incomes, and on helping businesses and firms survive until restrictions are relaxed . this has included, for example, income supports in the form of a flat-rate pandemic unemployment payment of € per week for individuals who lose their jobs due to the pandemic, as well as a temporary wage subsidy scheme, which enables employees, whose employers are affected by the pandemic, to receive significant supports directly from their employer through the payroll system. other measures undertaken include payment breaks on mortgage, personal, and business loans, liquidity funding for businesses, guaranteed loan schemes and deferred tax payments, as well as moratoriums on evictions and rent increases. beirne et al found that the measures announced by the government, and in particular the pandemic unemployment payment, reduced the numbers exposed to extreme income losses by about a third. nonetheless, more than , households lost between % and % of their incomes, with smaller numbers suffering even heavier losses. the department of finance announced increased expenditure of € billion to account for measures taken in response to covid- , including income supports. it estimates that the general government deficit could increase to . % of gdp this year (see table ), or possibly as much as % if the easing of restrictions is delayed and large parts of the economy remain closed. this large deficit is driven by both the expenditure measures implemented by the government and decreases in taxation revenue arising from reduced economic activity, and will lead to an increase in the debt-to-gdp ratio to an estimated %. overall, the consensus amongst economic commentators, including the irish fiscal advisory council (ifac) , , appears to be that ireland, given its recent strong economic performance and relatively healthy public finances, is reasonably well positioned to meet the economic challenges of covid- and that it should be possible to avoid a return to severe fiscal adjustments. nonetheless, this is predicated on the containment of the virus and a return to normal patterns of economic activity in the second half of . a striking feature of how the health system has prepared for and responded to the covid situation is that essentially it has been identical to what a tax-financed public health system would involve. people have not been charged for any aspect of care associated with the virus. the hse took over the operation of private hospitals early in the crisis to increase capacity. while the universal, free-to-the-user nature of care for covid- patients may bolster the case for a one-tier health system financed primarily by taxation, the difficulties of moving to such a system can be seen in the anomalous position that many patients in the private health system found themselves in. ireland's land border with northern ireland is another area which deserves close attention during this health emergency. counties along the border with northern ireland are among those with the highest rate of cases and deaths per capita (see figures and ) . free movement across this border is an obvious cause for concern, particularly when two different public health and testing strategies are being pursued in the jurisdictions. northern ireland has thus far carried out less community testing. as of july rd , northern ireland had completed , tests ( tests per , inhabitants) while the equivalent figure for the republic was , tests ( tests per , inhabitants). there are also significant differences in death rates between ireland and northern ireland and between ireland and the uk mainland . much of the response by healthcare decision-makers in ireland, particularly in the first month of the pandemic, focused on hospital-related issues. this was certainly understandable given the unfolding situation in some other countries. nursing homes and other residential centres did not receive sufficient attention during that phase of the pandemic. the focus of attention on the hospital system can at times obscure the fact that the real battle needs to take place upstream in our communities, including long-term residencies. further study of the individual components of public health advice that has clearly worked is required so we can be more focused in our response to further outbreaks of covid- . improved information on symptoms reporting by the general public or likely diagnoses observed by gps and other healthcare workers in our communities, along with better and more regular updates on testing and contact tracing will all contribute to better understanding of what is happening in our communities, the breeding ground for covid- . a further area of promise is the introduction of a contact tracing app which was downloaded by over a quarter of the population within a week of being launched. all of this additional data and research will be of utmost importance if we wish to be able to employ more focused yet effective measures rather than relying on a national lockdown. to conclude, we offer some brief thoughts on what lessons we have learned that might help ireland respond to a potential second or third wave of the pandemic. these observations, speculative as they might be, may also be useful to readers and policy makers in other countries. . the hospital and long-term care system in ireland has suffered from significant under-investment for many years. a second wave during the winter when the public hospital system has historically operated near or beyond capacity is likely to prove a much more serious challenge than that posed by the first wave. the pandemic may have strengthened the case for a universal health system but it has also underlined how difficult bringing that about will be given the current hybrid model of health care provision and financing. short-term interventions, such as the raid development of respiratory hubs in the community, need to be prioritised and adequately resourced. . the public health system itself is another area that has suffered from many years of significant under-investment. one area of particular concern that the pandemic has highlighted is the lack of a comprehensive electronic health record system. the absence of such a system will make dealing with a second wave much more challenging. organization for economic cooperation and development. health at a glance: oecd indicators. paris. organization for economic cooperation and development universal health care in ireland-what are the prospects for reform? the sustainability of the irish health care system sláintecare -a ten year plan to achieve universal healthcare in ireland dublin: department of health the impact of covid- on people who use and provide long-term care in ireland and mitigating measures ireland. epidemiology of covid- in ireland -daily reports covid- deaths and cases series . cork. central statistics office performance management and improvement unit-daily operations update-covid- covid- (coronavirus: stay safe guidelines. dublin: department of health department of the taoiseach [prime minister], ireland. government agrees next phase of ireland's covid- response no arrests for covid- breaches in last week of june roadmap for reopening society and business covid- summaries of evidence covid- health claims -tact checked living mapping and living systematic review of covid- studies ireland's contact-tracing app success. the guardian private hospitals takeover agreed without 'luxury' of due diligence. the irish times survey suggests one third postponed medical treatment during pandemic. rte (the internet some cancers missed due to pause in screenings, covid- committee told. the irish times helplines during covid- : 'there is an awful lot more drinking going on at home'. the irish times central statistics office social impact of covid- survey. cork. central statistics office ireland facing a 'tsunami' of mental health problems. the irish times department of finance, ireland. draft stability programme update , economics division, department of finance cso statistical release, monthly unemployment ) fiscal policy through the crisis: support for individuals. ireland's covid- crisis response: perspectives from social science the potential costs and distributional effect of covid- related unemployment return to austerity can be avoided. the irish times dublin: irish fiscal advisory council coronavirus (covid- ) statistics coronavirus (covid- ) statistics key: cord- -p j kt authors: wiley, lindsay f title: public health law and science in the community mitigation strategy for covid- date: - - journal: j law biosci doi: . /jlb/lsaa sha: doc_id: cord_uid: p j kt in a crisis like the covid- pandemic, the role of judges is first and foremost to adjudicate urgent requests for temporary restraining orders and preliminary injunctions. this means that judges hearing challenges to bans on gatherings, orders to close gun shops, orders to halt abortion care, and detention of civil immigration detainees in crowded and unsanitary conditions are issuing orders based on the parties’ pleadings alone. there is no time—yet—for the discovery, expert testimony, or amicus briefs from professional groups that typically inform assessments of science by judges. this essay examines the role public health science is likely to play in the coming months as judges field challenges to mandatory orders adopted as part of the community mitigation the covid- pandemic. it identifies voluntary guidelines from international and federal health agencies as a resource judges rely on heavily in reviewing emergency communicable disease control orders and argues that transparency of and accountability for guidelines should therefore be held to a higher bar than their voluntary status might otherwise suggest. u n c o r r e c t e d m a n u s c r i p t the bay area orders, which broke the floodgates on mandatory sheltering-in-place as a strategy for mitigating the spread of covid- in the united states, originated in post- / public health preparedness plans and long-standing relationships between public health scientists and lawyers. the powerful combination of public health science and law has prompted more than its fair share of legal and ethical controversy. from compulsory vaccination orders to sanitary cordons, from "big gulp bans" to prohibitions on the sale of tobacco products at pharmacies, public health laws have often put judges in the position of assessing the reasonableness of restrictions on individual and economic liberty. the standards of review judges have developed to guide this task require political leaders to articulate not only the purpose of their actions but also the fit between their ends and the means they have adopted. assessing the means-ends fit usually boils down to a discussion of scientific evidence and guidelines. although the law governing public health emergency orders is surprisingly unsettled, public health law experts widely agree that an assessment of the "necessity, effectiveness, and scientific rationale" for intrusive measures is a key feature of judicial review. in a crisis like the covid- pandemic, the role of judges is first and foremost to adjudicate urgent requests for temporary restraining orders and preliminary injunctions. this means that judges hearing challenges to bans on gatherings, orders to stay at home except for essential work and needs, orders to close gun shops, orders to halt abortion care, and detention of civil immigration detainees in crowded and unsanitary conditions are issuing orders based largely on the parties" pleadings alone. there is little time-yet-for the discovery, expert testimony, or amicus briefs from professional groups that typically inform assessments of science by judges. this essay examines the role of public health scientific guidelines in the adjudication of legal challenges to mandatory orders adopted as part of the community mitigation strategy for the covid- pandemic. this examination of judicial precedents arising out of emergency communicable disease control measures-prior to and during the covid- pandemic-reveals that judges rely heavily on guidelines from the world health organization (who) and the u.s. centers for disease control (cdc). this may be cause for concern, given that federal guidelines for covid- have been slow to respond to the reality of covid- "s rapid spread and rising death toll in the us. the white house has issued guidelines independently of cdc and both sets of guidelines have fallen short of endorsing the orders mandating all residents to stay at home that the majority of states and many local governments have imposed. the essay concludes by arguing that because guidelines issued by international and federal agencies play an important role in adjudication of conflicts between emergency communicable disease control orders and civil liberties, they should be held to a higher standard of transparency and accountability than their voluntary nature might otherwise suggest. to mitigate the spread of covid- , federal, state, and local officials have exercised broad powers available to them under public health statutes and emergency declarations to close businesses and restrict the movement of individuals outside their homes. a widely cited report assumes that multi-layered non-pharmaceutical interventions, also known as community mitigation measures, will be necessary for at least three months to reduce peak impacts on health systems. while we wait for a safe and effective vaccine, some degree of community mitigation may be needed on an intermittent basis-in some places at some times-for the year or longer it takes to develop and widely distribute a safe and effective vaccine. past experience shows that community mitigation-through a combination of government supports, protections, and restrictions-is an important strategy to slow the spread of viral epidemics in addition to efforts to increase access to and the capacity of the health care system and the development and deployment of effective medical countermeasures such as vaccines and antivirals (see figure ). early evidence suggests that spread of the virus by people whose infections are not detected may play a particularly important role in covid- , potentially making more targeted containment strategies-measures to test and isolate individuals known to be infected and trace and quarantine their known contacts-insufficient in the absence of broader community mitigation measures to reduce out-of-household contacts among the general population. due to the unprecedented nature of the covid- crisis, the intrusive measures currently in force across many us jurisdictions are largely untested. benefits are anticipated based on modeling and planning exercises developed in preparation for a novel influenza pandemic, and limited studies of measures implemented in mainland china, hong kong, and parts of europe in ongoing research and surveillance are needed to assess these measures in real time. legal authority to impose restrictions on businesses, individuals, and travel may be inferred from the broad public health powers available to state governments and specific delegations of emergency powers to governors and mayors, but these measures are subject to individual rights constraints. by the end of march , lawsuits challenging gathering bans and stay at home orders were pending in the new hampshire state court system and the eastern district of new york. suits requesting injunctive relief for people in criminal custody and immigrant civil detention were pending in at least three federal jurisdictions. several suits on behalf of legal practices, firearms retailers, abortion service providers were also pending in multiple jurisdictions. more court challenges are likely to come as restrictions remain in place for weeks and months. modeling studies and cdc guidelines for pandemic influenza suggest that closing schools and other places where people gather, as every state has done to some extent in response to covid- , impedes the spread of epidemics. school closures have been deployed on a limited basis by individual districts in the us to control the spread of novel influenza viruses, with encouraging results. particularly when schools and workplaces close, it may be necessary to close other places where people would otherwise congregate. state and local restrictions on business operations under penalty of citations, fines, and loss of licenses have been ordered in nearly every us jurisdiction in response to nearly all states and many local governments have ordered bars, restaurants, theaters, gyms, shopping malls, and other settings where people tend to gather to close or limit on-site occupancy. in a majority of jurisdictions, officials have gone further, closing all non-essential businesses to the public, with specified exceptions for health-care, food and agriculture, home repair, first responders, and a few other sectors deemed essential. many have also prohibited elective medical procedures that are not time-sensitive, with a goal of promoting social distancing and preserving health care capacity. at the furthest end of the spectrum, several kylie e c ainslie, et in late april , several jurisdictions indicated that they would begin to ease restrictions on businesses, but warned that limits may need to be re-tightened in response to disease trends. even in times of low community transmission, officials indicated that restrictions on density (e.g., capping occupancy at % of what is permitted under fire safety codes) and interactions among employees and customers (e.g., limiting nonessential retail to curbside pickup) may be in place for long durations. public health authority to regulate businesses under the banner of public health is vast, but constitutional requirements of due process and equal protection of the law bar these powers from being wielded in an arbitrary or capricious manner. in addition, heightened standards of review may apply to restrictions that implicate fundamental rights, such as the right to bear arms or access family planning services. businesses affected by closures could argue that mandated closure of uncrowded, but non-essential shops where customers and employees may maintain physical distance are arbitrary and not reasonably grounded in evidence about how novel coronavirus is transmitted. though authorities could defend these bans on the ground that enforcing physical distancing requirements within each facility would be too cumbersome. the economic impacts of restrictions on businesses have already been devastating. if maintained for a long duration, the effects could be catastrophic, particularly for low-income families and small businesses. congress, federal agencies, and state and local governments have begun to implement programs to provide financial assistance, direct delivery of food and other necessities, and legal protections from eviction and utility shut-offs. yet more supportive measures will undoubtedly be needed as the crisis continues to unfold. bans on large gatherings are a cornerstone of social distancing plans developed in pandemic preparedness exercises. in the us, these restrictions have been tightened as evidence of novel coronavirus community transmission mounted, from bans on groups of , to , to , to , to groups of any size. at times when community transmission is low in any given area, bans could be eased, raising the limit on attendance while requiring physical distancing to be practiced by attendees. physical distancing, particularly for long durations, can severely disrupt access to social and emotional supports. in another early court challenge to state social distancing measures, the plaintiff argued that new hampshire"s ban on large gatherings violates their first amendment rights to assembly and freedom of expression as well as fourteenth amendment right to due process. a suit filed in the eastern district of new york raised a similar challenge to new york"s gathering ban and stay at home order. by the end of march , more than half of states had gone further than banning gatherings by issuing mandates ordering residents to stay at home, with relatively broad exceptions for meeting essential needs and exercising outdoors, enforceable through criminal fines and jail time. while restrictions on gatherings are supported by public health emergency response guidelines, orders confining individuals to their homes are more controversial and have not been assessed as thoroughly in pandemic influenza planning. due to logistical constraints, even mandatory orders to stay at home are dependent on widespread voluntary compliance to be successful. compliance requires public acceptability and trust in government, which may be eroded if restrictions are harshly enforced or maintained for long durations. restrictions on assembly and involuntary confinement of individuals to their homes are typically subjected to the heightened judicial scrutiny, but may be justified by balancing the curtailment of individual liberty against compelling government needs. in the us, limitedduration curfews ordering individuals to stay indoors have occasionally been used by state and local officials to protect the public"s health and safety and prevent civil unrest in the event of natural disasters and other emergencies. courts reviewing challenges to covid- orders might also look to decisions upholding emergency orders restricting access to and movement within specified areas during limited periods of civil unrest. in , for example, a federal appellate court upheld an emergency restricted zone to protect public safety during a meeting of the world trade organization in downtown seattle. but long-term restrictions on activity outside the home by all residents without clear criteria or planning for when mandates might be eased or lifted are deeply problematic and require stronger justification that limited curfews or restricted zones. wholesale restrictions on personal movement do not allow for the individualized risk assessments courts have typically required to quarantine specific individuals infected or exposed to a communicable disease, as discussed below. though some restrictions, such as requirements to maintain a distance of at least six feet from non-household members, might be permissible in theory in light of the best available scientific evidence regarding the spread of novel coronavirus, enforcement on the ground could be highly problematic. even in the absence of prohibited discrimination based on race, ethnicity, or religion, a plaintiff could claim that spotty police enforcement was arbitrary and capricious. given that some local police departments have indicated they will be pursuing more proactive enforcement, threatening large fines and the possibility of jail time, the limits of public health authority to confine individuals could be tested in the courts as the pandemic continues to impact our lives in the months and years to come. some forms of travel restrictions and quarantine of individual travelers may be justified if they are truly necessary to protect people in areas with low community transmission from exposure to people who have recently traveled from areas with high transmission. guarded boundaries between or within us states and territories would raise difficult constitutional questions. bans on interstate travel imposed by state governments would have to navigate constitutional doctrines that constrain states from discriminating against non-residents and interfering with interstate commerce. the federal government has authority to close state borders pursuant to its authority to regulate interstate commerce, subject to individual rights constraints. limited geographic quarantines were established by local governments in some parts of the us more than a century ago to control bubonic plague. at least one lower federal court struck down a quarantine around a portion of san francisco, partly on the grounds that it discriminated against chinese americans and partly on the grounds that it confined the infected and the uninfected together without preventing the spread of disease within the cordon. reverse cordons with mandatory quarantine for all individuals permitted to enter from outside were established in some (mostly geographically isolated) local areas with low or no community transmission during the flu pandemic, and ad-hoc "shotgun quarantines" were adopted by some localities during yellow fever outbreaks in the south beginning in the s, but these measures do not appear to have been challenged in court. completely barring people from exiting an area severely affected by a disease outbreak, absent an assessment of the risks posed by individual travelers, would violate constitutional prohibitions against the deprivation of life and liberty without due process of law under almost every conceivable scenario. barring entry into an area where community transmission is low would implicate individual rights to travel. imposing a travelers" quarantine, as more than a dozen states have ordered for covid- , requiring individuals entering the area to be separated from others for a reasonable incubation period, would provide a less restrictive alternative to completely closed borders. mandatory restrictions in the absence of social supports to minimize secondary harms are deeply unjust. moreover, social supports maximize compliance with guidance and help maintain the public"s trust, bolstering the effectiveness of public health measures. upon initiation of school and workplace closures and guidance or orders to stay at home, governments should act immediately to ensure safe, sanitary, and accessible housing conditions for all. governmental responsibility should be exercised immediately to secure the health and safety of people in custody, detention, and foster care. wherever possible, people in custody should be released from crowded conditions and provided with supports for housing and other essential needs. people experiencing homelessness should be exempted from enforcement of mandatory orders to shelter in place (as most, but not all orders currently in effect have provided). moreover, safe, sanitary, and uncrowded shelter that is physically accessible for people with disabilities should be offered to people who are unhoused, experiencing homelessness, or living in communal settings. people who are experiencing domestic abuse should be proactively protected at a time when they may be cut off from outside contact and supports. safe and sanitary housing regulations should be proactively enforced to mitigate increased exposure to lead, mold, pest infestations, and other hazards, particularly for people living in low-income, federally-financed, or rental housing. federal, state, and local governments are acting to provide legal protections to preserve employment, income, housing, and utilities and financial assistance and direct delivery of essential goods and services for those in need. many of these measures are short-term, however. long-term measures may be required as the pandemic and our response to it unfolds in the coming months. over time, as community transmission is assessed to be minimal in some areas at some times, protective measures and accommodations will be particularly crucial for people who are at the highest risk of severe complications and death from covid- , who may need to stay at home even as others are able to return to work. though a relatively small number of vocal protesters have garnered media attention, the reality is that compliance with covid- community mitigation measures has been widespread and willing for the most part so far. due to logistical, legal, and ethical constraints, restrictions that are mandatory in theory rely on widespread voluntary compliance in practice. as levels of community transmission are assessed to be minimal in some places at some times, mandatory restrictions should be lifted and replaced with voluntary guidelines, but restrictions may need to be re-tightened periodically to keep the curve of the epidemic within health care capacity. throughout this crisis, sustained social supports to justify and enable safe compliance with restrictions and recommendations will be absolutely crucial to the success of the public health response to covid- . long-term, state-wide orders to close nearly all business operations and shelter in place were untested in us courts prior to the covid- pandemic. a small number of court precedents reviewing emergency communicable disease control measures and quarantines of individuals suspected of being exposed provide some guidance to courts reviewing challenges to covid- orders. in these pre-covid cases, judges evince a strong desire to defer to the scientific judgments of elected officials. in jew ho v. williamson, for example, judge william morrow assured authorities that he would "give the widest discretion" to actions taken "in the presence of a great calamity." but he also affirmed his grave constitutional responsibility to review government intrusions upon civil liberties. "is the regulation in this case a reasonable one?" he asked. "is it a proper regulation, directed to accomplish the purpose that appears to have been in view? that is a question for this court to determine." quarantines imposed on individuals, homes, and geographic districts were not an uncommon occurrence in the eighteenth and nineteenth centuries. cases adjudicating legal issues arising from quarantine orders were almost exclusively handled by the state courts, however, and federal rights were not widely understood to be implicated. at the turn of the twentieth century, federal courts began to hear challenges based on individual rights protected under the fourteenth amendment"s guarantees of due process and equal protection. in pre-civil rights era communicable disease control cases, judges applied standards of review that were considerably more deferential than the strict scrutiny standard that civil rights era precedents would later adopt for review of infringements upon fundamental rights and suspect classifications (such as those based on race, ethnicity, or religious affiliation). person to person and place to place and public health methods for combatting it. dr. stephen, who appears to have been invoked as an expert by the plaintiffs, averred that no proper or scientific precautions have been taken by [the san francisco board of health] to prevent the spread of … disease. [they] have proceeded from erroneous theories to still more erroneous and unscientific practices and methods of dealing with the same; for, instead of quarantining the supposedly infected rooms or houses in which … deceased persons lived and died, and the persons who had been brought in contact with and been directly exposed to said disease, [the] defendants have quarantined, and are now maintaining a quarantine over, a large area of territory, and indiscriminately confining therein between ten and twenty thousand people, thereby exposing, and they are now exposing, to the infection of the said disease said large number of persons. informed by dr. stephen"s affidavit, judge morrow demonstrated a remarkably nuanced understanding of the distinction between individual quarantines confining individuals "afflicted" with a highly communicable disease "to their own domiciles until they have so far recovered as not to be liable to communicate the disease to others" with "the object … to confine the disease to the smallest possible number of people" and geographic quarantine (also known as cordon sanitaire), whereby officials "place , persons in one territory, and confine them there," at which point "the danger of such spread of disease is increased, sometimes in an alarming degree, because it is the constant communication of people that are so restrained or imprisoned that causes the spread of the disease." morrow also decried the discriminatory character of the sanitary cordon, which operated almost exclusively against people of chinese descent. his order took a measured approach, lifting the general quarantine "thrown around the entire district" while affirming the authority of city officials "to maintain a quarantine around such places as it may have reason to believe are infected by contagious or infectious diseases." jacobson v. massachusetts, the case which the us supreme court upheld a compulsory vaccination mandate adopted during a smallpox outbreak, adopted a far more deferential posture toward the judgement of the massachusetts legislature and cambridge board of health as to matters of science. jacobson was also an emergency powers case, though it has been widely applied in non-emergency contexts, such as challenges to school vaccination mandates. the cambridge board of health adopted an adult smallpox vaccination mandate following its declaration of a local smallpox outbreak. thus, the court framed the case in terms of "authority to determine for all what ought to be done in an emergency." id. at . dr. stephen described himself as having "held various official positions, such as surgeon to the police, medical officer of health, parish medical officer, and public vaccinator," and having, "for the past thirteen years in the state of california," "given much time and study to the literature of the bubonic plague." he also noted that he was "the regularly appointed physician of the chines [sic] empire reform association, which numbers several thousand chinese residents in the state of california." id. at . id. id. at . u.s. ( ). id. at . the jacobson court grappled mightily with how to judge elected officials" adoption of compulsory public health measures in the absence of perfect information about risks and benefits. justice harlan"s opinion quoted a lengthy passage from a new york state court decision upholding a school vaccination mandate to prevent smallpox outbreaks: the appellant claims that vaccination does not tend to prevent smallpox, but tends to bring about other diseases, and that it does much harm, with no good….the common belief, however, is that it has a decided tendency to prevent the spread of this fearful disease, and to render it less dangerous to those who contract it…. the possibility that the belief may be wrong, and that science may yet show it to be wrong, is not conclusive; for the legislature has the right to pass laws which, according to the common belief of the people, are adapted to prevent the spread of contagious diseases…. while we do not decide, and cannot decide, that vaccination is a preventive of smallpox, we take judicial notice of the fact that this is the common belief of the people of the state, and, with this fact as a foundation, we hold that the statute in question is a health law, enacted in a reasonable and proper exercise of the police power. jacobson upheld the compulsory vaccination mandate as consistent "with the liberty which the constitution the united states secures to every person against deprivation by the state." justice harlan recognized that individual liberty is not "an absolute right in each person to be, in all times and in all circumstances, wholly free from restraint." rather, "every wellordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand." harlan upheld the emergency vaccination mandate on the grounds that the board of health reasonably believed "it was necessary for the public health or the public safety." in closing, however, harlan "observe[d]… that the police power of a state … may be exerted in such circumstances, or by regulations so arbitrary and oppressive in particular cases, as to justify the interference of the courts to prevent wrong and oppression." the court declined to "usurp the functions of another branch of government," by "adjudg[ing], as matter of law, that the mode adopted under the sanction of the state, to protect the people at large was arbitrary, and not justified by the necessities of the case." but its decision also recognized that the "acknowledged power of a local community to protect itself against an epidemic threatening the safety of all might be exercised in particular circumstances and in reference to particular persons in such an arbitrary, unreasonable manner, or might go so far beyond what was reasonably required for the safety of the public, as to authorize or compel the courts to interfere for the protection of such persons." surprisingly many courts have continued to employ jacobson"s pre-civil rights era standard of "non-arbitrary and justified by public health necessity" (with "necessity" not being used in the strict sense of the word) to judge routine compulsory public health measures (especially school vaccination mandates) while declining to decide whether strict scrutiny applies. lower federal court decisions on challenges to individual quarantine orders for smallpox and ebola virus disease are also instructive for judges fielding covid- constitutional challenges. although these cases have been decided during and after the civil rights era, in which courts recognized the importance of more searching judicial review to protect fundamental rights to liberty, their approach to scrutinizing emergency communicable disease control orders has been non-strict in ways that mirror jacobson and jew ho (though without necessarily citing them). in , the federal district court for the eastern district of new york declined to release ellen siegel from a federal quarantine facility where she was being held after visiting stockholm, sweden at a time when it was designated a "small pox infected local area" by swedish health authorities. in us ex rel. siegel v. shinnick, judge john francis dooling, jr. carefully reviewed the international sanitary regulations adopted by the world health organization (who), which deferred to the declarations of local health officials as to when a local area is "free of local infection." he also noted who guidelines indicating that declaration of local infection could be safely terminated "twenty-eight days after the last reported case of small pox dies, recovers or is isolated." siegel argued that the designation of stockholm as affected by smallpox at the time of her visit was in error because (as both parties agreed) the most recently reported case had later been determined to be a false positive. dooling could have done the math himself and determined that, following who guidelines, stockholm could have ( - ) . but these orders do not trigger the same degree of deference from courts that emergency orders adopted under conditions that limit the feasibility of rigorous scientific risk assessments and so i do not address them here, given limits on space. been designated safe from smallpox prior to siegel"s arrival. but instead he deferred to swedish health authorities: it does not appear that others are legally competent to (as they would be hopelessly handicapped in seeking to) make a determination on such a question as whether or not stockholm can now be regarded as not an infected local area on the basis that the last reported case went into isolation [more than days prior to siegel"s arrival]; responsibility for applying that standard rests with the territorial health administration and depends on whether, also, all measures of prophylaxis have been taken and maintained to prevent recurrence of the disease. it is idle and dangerous to suggest that private judgment or judicial ipse dixit can, acting on the one datum of the date june as the last identified and reported case, undertake to supercede [sic] the continuing declaration of the interested territorial health administration that stockholm is still a small pox infected local area. although he deferred to swedish health authorities" designation of stockholm as an affected area, judge dooling carefully reviewed the actions of the federal public health service, which ordered siegel"s quarantine upon her return to the us. in upholding the quarantine order, dooling pointed to the importance of an individualized risk assessment, "taking into account previous vaccinations and the possibilities of her exposure to infection." siegel was initially asked to present a certificate of vaccination against smallpox, but she had failed to produce detectable antibodies following a series of vaccination attempts and could not be certified as successfully vaccinated. dooling noted that federal health officials had not detailed siegel"s husband, who apparently had been successfully vaccinated prior to the trip to stockholm. the judge also emphasized the need to adopt less restrictive alternatives, where available. he urged "caution[] against light use of isolation," which "is not to be substituted for surveillance unless the health authority considers the risk of transmission of the infection by the suspect to be exceptionally serious." the order in siegel was, however, highly deferential to federal health officials" scientific risk assessment based on the best available evidence and relying on the precautionary principle. dooling noted that "the judgment required is that of a public health officer and not of a lawyer used to insist[ing] on positive evidence to support action; their task is to measure risk to the public and to seek for what can reassure and, not finding it, to proceed reasonably to make the public health secure. they deal in a terrible context and the consequences of mistaken indulgence can be irretrievably tragic. to supercede [sic] their judgment there must be a reliable showing of error." men" who testified on behalf of the federal defendants as "shar[ing] a concern that was evident and real and reasoned." in a footnote, dooling noted that the procedure followed by health officials was not directly constrained by federal or international regulations, but "remains a function of the gravity of the situation as measured by their expert judgments dispassionately formed." his description of the defendant"s "expert" and "dispassionate[]} determinations as not only reasoned but "evident and real" appears to be consistent with the "non-arbitrary and justified by the necessities of the case" standard applied by the jacobson court. more recently, state and federal courts fielded two lawsuits involving kaci hickox, a nurse who, upon her return from treating ebola patients in sierra leone, was briefly detained by federal health authorities for a health screening at newark international airport, then handed over to new jersey officials who held her under a state quarantine order, then released to her partner"s home state of maine where the governor ordered state troopers to guard her home and follow her movements while health officers from the state"s center for disease control monitored her temperature and symptoms daily. first, a state trial judge in maine was asked to impose a court-ordered home quarantine, which hickox resisted on the grounds that it was not based on a reasonable assessment of the risk she posed to others. hickox later filed a suit for damages in the federal district court in new jersey. in hickox v. mayhew, maine state trial court judge charles laverdiere, followed his predecessors in looking to guidelines from health agencies. in the press, hickox argued that because that she did not have any symptoms and the best available evidence demonstrated that transmission by asymptomatic individuals was not a concern, an involuntary quarantine was inappropriate. judge laverdiere ultimately determined that hickox could properly be subjected to an order mandating direct active monitoring (with direct observation by state health authorities at least once per day to review symptoms and monitor temperature with a second daily follow-up by phone), a less restrictive limitation on her liberty than the home quarantine restrictions the state had requested. in reaching this result, the judge noted that "the only information that the court has before it regarding the dangers of infection posed by" hickox, was from the affidavit of "shiela pinette, d.o., director of the maine center for disease control and prevention, together with the attachments from the u.s. centers for disease control." in particular, both parties agreed that hickox was "asymptomatic (no fever or other symptoms consistent with ebola), as of the last check pursuant to her direct active monitoring." judge laverdiere followed dr. pinette"s conclusion that the imposition of direct active monitoring was functionally dictated by cdc"s (voluntary) guidelines: "therefore the guidance issued by u.s. cdc states that she is subject to direct active monitoring. health care workers in the "some risk" category require direct active monitoring for the -day incubation period." in his concluding "observations," laverdiere noted that he was "fully aware of the misconceptions, misinformation, bad science and bad information being spread from shore to shore … with respect to ebola" and "that people are acting out of fear and that this fear is not entirely rational. however, whether that fear is rational or not, it is present and it is real." the judge chided hickox to ensure that her "actions at this point, as a health care professional, need to demonstrate her full understanding of human nature and the real fear that exists" and "guide herself accordingly." in a subsequent suit arising out of her initial quarantine in new jersey, hickox"s constitutional arguments were rejected, but she eventually reached a settlement on state law grounds that included new protections for people quarantined in new jersey. in hickox v. christie, federal district court judge kevin mcnulty had the benefits of time and hindsight. he fielded the suit for damages several months after the quarantine on hickox had been lifted, when it was clear that she never contracted ebola virus and ebola panic among americans had passed. still, judge mcnulty relied on cdc guidance to justify the state"s quarantine. noting that he did "not need to make any finding as to its accuracy," he "simply note[d] that the authorities could reasonably have relied on it" at the time they detained hickox. unlike laverdiere, mcnulty took a somewhat more skeptical stance toward cdc guidance, which adopted a less cautious approach toward exposed but asymptomatic individuals than new jersey officials applied. mcnulty pointed out that cdc guidance did not automatically dictate how hickox should have been handled, because the guidance "contain[ed] recommendations, and it note[d] the importance of public health officials" exercise of their judgment." mcnulty declined to formally endorse requirements of individualized risk assessments and the least restrictive means, which public health law experts have urged are constitutionally required for mandatory quarantines of individuals believed to pose a risk of transmitting communicable disease. he "assume[d] without deciding that the… "individualized assessment" of the individual"s illness and ability or willingness to abide by treatment can, mutatis mutandis, be adapted to the situation of a temporary detention for observation based on a risk of infection." ultimately, he concluded that "an erroneous application of cdc guidelines does not correspond to a constitutional cause of action." federal guidelines have struggled to keep pace with the restrictions imposed by governments in response to the spread of sars-cov- . with respect to community mitigation and non-pharmaceutical interventions, on march , cdc quietly posted a document titled "implementation of mitigation strategies for communities with local covid- transmission." described as "a framework for actions which local and state health departments can recommend in their community to both prepare for and mitigate community transmission of covid- ," this document recommended that "these actions should be guided by the local characteristics of disease transmission, demographics, and public health and healthcare system capacity." in places with "substantial" community transmission, defined as occurring when there is "[l]arge scale community transmission," with "healthcare staffing significantly impacted, multiple cases within communal settings like healthcare facilities, schools, mass gatherings etc.," the framework recommended that "[a]ll individuals should limit community movement and adapt to disruptions in routine activities (e.g., school and/or work closures) according to guidance from local officials." the framework additionally recommended that in periods of substantial community transmission, organizations should "cancel community and faith-based gatherings of any size." separately, cdc issued guidelines for large community events and mass gatherings recommending cancellation of "gatherings of more than people for organizations that serve higher-risk populations." notably, even as nearly every state issued mandatory orders restricting the operation of commercial businesses, cdc"s only guidance for "keeping commercial establishments safe" recommended disinfection of surfaces, steps to stagger customer flow and frequent hand washing, while the cdc website suggested businesses "[c]onsider establishing policies and practices for social distancing … if recommended by state and local health authorities." in mid-march, cdc also issued a series of specific guidance documents for specific localities and states, including the cities of santa clara, seattle, and new rochelle, and the states of florida and massachusetts. notably the cdc guidance for santa clara recommended "laser focused" and less restrictive interventions that were inconsistent with the county-wide shelter-in- place order the santa clara health officer issued a day earlier. cdc guidance for other locations similarly recommended less stringent measures than state and local authorities had already adopted. the white house issued competing guidance on march . the " days to stop the spread" guidelines, later amended to " days," recommended that certain groups-people who feel ill, people who test positive for coronavirus and their family members, and people who are older or who have serious underlying health conditions that put them at increased risk-should stay at home. it also recommended that everyone should "avoid social gatherings in groups of more than people," "eating or drinking at bars, restaurants, and food courts," and "discretionary travel, shopping trips, and social visits." with respect to closures, the guidelines noted that "[g]overnors in states with evidence of community transmission should close schools in affected and surrounding areas" and "[i]n states with evidence of community transmission, bars, restaurants, food courts, gyms, and other indoor and outdoor venues where groups of people congregate should be closed." this guidance adopted a far less cautious stance toward mitigating the spread of novel coronavirus than the mandatory stay-at-home and non-essential business closure orders in effect in the majority of states at the time the white house guidelines were released. subsequently, on april , the white house released new "guidelines for opening up america again," which set forth a phased approach to resuming social gatherings, resuming elective medical procedures, and reopening schools and the types of businesses that the previous white house guidelines had recommended for closure (including bars, restaurants, gyms, and venues where groups of people gather).. the guidelines established "gating" criteria for reopening "large venues" and gyms after a sustained downward trajectory in the number of syndromic and reported cases for days and at a point when hospitals are able to treat patients without resorting to crisis standards of care and to test health care workers exposed to novel coronavirus. if the same gating criteria are met following the reopening of gathering places in phase one, states were advised to proceed to phase two, in which schools, bars, and other higherrisk settings are reopened. the few courts that have reviewed early covid- civil liberties challenges to date have followed pre-covid precedents in relying on voluntary guidelines from international and federal authorities, but that may prove more challenging as restrictions imposed by state and local governments exceed what cdc has endorsed, particularly given that the white house is offering guidelines that conflict with cdc"s. in binford v. sununu, a new hampshire state trial court upheld the state"s ban on gatherings of or more people (new hampshire later lowered the limit for groups) and prohibition of dine-in service at bars and restaurants, rejecting the plaintiffs" argument that these restrictions impermissibly infringed upon his rights under the first and fourteenth amendments. in an opinion issued on march , nine days after the white house"s " days to stop the spread" guidance went into effect, judge john c. kissinger noted that these restrictions were "clearly supported by the recommendations put forth by the white house and cdc" without specifying which recommendations were applicable. judge kissinger undoubtedly reached the right result in upholding the ban on gatherings of or more people, but he based his holding on troubling reasoning. adopting the position that the governor has "authority to suspend civil liberties" in an emergency, the court applied a "good faith/some factual basis" test to uphold the restrictions. this test, which comes from an th circuit case upholding a nightly curfew in miami-dade county in the aftermath of hurricane andrew, eschews the courts" constitutional responsibility to determine whether the state has adopted "a proper regulation, directed to accomplish the purpose that appears to have been in view?" in the words of judge morrow in jew ho. the lack of clear guidelines from cdc supporting the state"s reasonable measure may have played a role in judge kissinger"s decision to resort to the extreme of adopting a suspension rule. in its objection to the plaintiff"s complaint, the state did not argue for suspension. it cited the th circuit hurricane case, but without specifically referring to or endorsing the suspension rule. the state also cited specific cdc and white house guidelines, which it described as recommending cancellation of planned gatherings of or more people, but (as noted above) the cdc"s guidance was limited to organizations "that serve higher risk populations" and neither guideline specifically endorsed mandatory limits on bar and restaurant service. in a situation where conflicting guidelines have been issued, a court applying a rational basis test or jacobson"s standard should defer to the choice of a political branch to follow the more cautious guidelines. in challenges based on civil liberties, this will typically result in upholding restrictions. but at the time binford was decided, no federal guidelines recommended bans on gatherings for the general population, leaving the state with little cover to defend its ban. in a higher profile case, the fifth circuit upheld application of the texas emergency order prohibiting elective medical care to all abortions, partially on the grounds that cdc had recommended preserving face masks and the centers for medicare and medicaid services had binford v. sununu, supra note . recommended limiting unnecessary medical procedures to reduce opportunities for disease transmission. in re abbott relied on a warped characterization of jacobson as establishing "the controlling standards, established by the supreme court over a century ago, for adjudging the validity of emergency measures." the majority set aside the heightened review typically applied to restrictions on abortion in favor of a rule that "the scope of judicial authority to review rights-claims" during "a public health crisis" is limited to cases where "a statute purporting to have been enacted to protect the public health, the public morals, or the public safety, has no real or substantial relation to those objects, or is, beyond all question, a plain, palpable invasion of rights secured by the fundamental law." moreover, the fifth circuit suggested that in a crisis, this minimal level of scrutiny applies equally to "one"s right to peaceably assemble, to publicly worship, to travel, and even to leave one"s home." although not explicitly endorsing a suspension principle, in re abbott"s manipulation of jacobson achieves essentially the same result: applying an exceedingly low standard of review in times of crisis. as robert gatter argued in his critique of ebola quarantine cases, judges" "responsibility to assure [relevant scientific] facts are discovered and accounted for … is inherent in even the most deferential standard of judicial review. a court asked to address whether a public health agency has acted reasonably and without abusing its discretion need not simply defer to the expertise of the agency without requiring that the agency to identify and explain the logic the agency deployed to reach its conclusion that quarantine was appropriate." the same is true of officials charged with developing emergency communicable disease control guidelines that, while technically voluntary, are likely to be relied on to enforce involuntary-and highly intrusive-measures by state and local governments. clear guidelines developed by cdc through transparent processes that include publication of peer reviewed analyses and literature reviews give states important cover for defending emergency orders in the face of civil liberties challenges. in the absence of an "easy" route to defending state and local restrictions as consistent with evidence-based guidelines, judges who wish to uphold emergency orders may resort to less searching forms of review. though the result-upholding the restrictions-may be the right one in most cases, a knee-jerk approach that endorses a governor"s authority to suspend the civil liberties protected by the federal constitution will not be helpful to developing a sustainable long-term strategy for mitigating the current pandemic or for future public health law preparedness efforts. as the fifth circuit"s coronavirus abortion decisions demonstrate, when courts abandon the ordinary levels of even if conflicting guidelines are released-as has been the case with separate sets of covid- guidelines coming from the white house and the cdc-courts following jacobson"s standard of review should defer to elected officials" choice as to which guidelines they adopt. a cautious set of guidelines may provide adequate cover to states to enforce some forms of community mitigation even if alternative, less cautious guidelines are available. and if a higher standard of review applies, as is the case for abortion restrictions, then the availability of a less restrictive alternative can and should lead courts to question the necessity of harsh limits. governments must earn the public"s trust by acting transparently, fairly, and effectively and communicating their plans and guidance clearly. the way we respond to the covid- crisis-how state and local governments wield authoritarian powers necessary to combat the spread of disease and how we protect the people who are most vulnerable to the disease itself and the secondary harms that will arise out of our efforts to combat it-will shape public health law and the society we live in for generations to come. ) (dismissing suit for damages by class of individuals quarantined under state orders in connecticut nurse says she won't have officials violate 'my civil rights new jersey accepts rights for people in quarantine to end ebola suit for a critical assessment of cdc"s ebola guidance and its effect on related court decisions, see robert gatter, ebola, quarantine, and flawed cdc policy, u. miami bus. l. rev. ( ); see also robert gatter, three lost ebola facts and public health legal preparedness cdc, implementation of mitigation strategies for communities cdc, resources for large community events & mass gatherings what every american and community can do now to decrease the spread of the coronavirus interim guidance for businesses and employers to plan and respond to coronavirus disease s recommendations for day mitigation strategies for days to slow the spread was later revised and replaced with days to slow the spread, the president's coronavirus guidelines for america trump announces guidelines for opening up america again guidelines: opening up american again citing centers for disease control and prevention three lost ebola facts, supra note key: cord- - jdf nt authors: poole, nigel; donovan, jason; erenstein, olaf title: agri-nutrition research: revisiting the contribution of maize and wheat to human nutrition and health date: - - journal: food policy doi: . /j.foodpol. . sha: doc_id: cord_uid: jdf nt research linking agriculture and nutrition has evolved since the mid- th century. the current focus is on child-stunting, dietary diversity and ‘nutrient-rich’ foods in recognition of the growing burdens of malnutrition and non-communicable diseases. this article concerns the global dietary and health contribution of major cereals, specifically maize and wheat, which are often considered not to be ‘nutrient-rich’ foods. nevertheless, these cereals are major sources of dietary energy, of essential proteins and micronutrients, and diverse non-nutrient bioactive food components. research on bioactives, and dietary fibre in particular, is somewhat ‘siloed’, with little attention paid by the agri-nutrition research community to the role of cereal bioactives in healthy diets, and the adverse health effects often arising through processing and manufacturing of cereals-based food products. we argue that the research agenda should embrace the whole nutritional contribution of the multiple dietary components of cereals towards addressing the triple burden of undernutrition, micronutrient malnutrition, overweight/obesity and non-communicable diseases. agri-nutrition and development communities need to adopt a multidisciplinary and food systems research approach from farm to metabolism. agriculture researchers should collaborate with other food systems stakeholders on nutrition-related challenges in cereal production, processing and manufacturing, and food waste and losses. cereal and food scientists should also collaborate with social scientists to better understand the impacts on diets of the political economy of the food industry, and the diverse factors which influence local and global dietary transitions, consumer behavioural choices, dietary change, and the assessment and acceptance of novel and nutritious cereal-based products. the sustainable development goals (sdgs) define the international development agenda to (united nations general assembly ). designing effective policies, strategies and programmes for achieving the sdgs is a complex and multidisciplinary process, requiring specialists to escape the substantive sectoral silos which characterise global development (waage et al. ) . because of multiple entry points to the agenda, agriculture should recover its place as the central driver for food and nutrition security, for achieving inclusive and sustainable economic growth, reversing environmental damage, and boosting the resilience and welfare of the most disadvantaged populations (omilola and robele ) . however, there has yet to emerge a cross-sectoral vision on the form that engagement between agriculture and nutrition should take. for the second half of the last century, the agriculture-nutrition interface was concerned, in broad terms, with the availability of and access to calories and protein. now, many countries are increasingly facing the 'triple burden' of malnutrition: i) undernutrition (hunger) and ii) micronutrient deficiencies on the one hand, and iii) overnutrition (overweight and obesity) on the other. the sdgs include the ambitious sdg 'zero hunger' by -which appears unachievable. in the state of food security and nutrition in the world ) fao et al. estimate that almost million people were still hungry in . the data confirm that the trend in the number of people affected by hunger globally has been rising since . preliminary assessments suggest that the current covid- health pandemic may add - million hungry people in . these trends imply that the number of hungry people will likely exceed million by , almost percent of the global population. the prevalence of child stunting has been declining and in was . percent, or million children, but will still fail to meet the sdg target. while we continue to combat undernutrition and micronutrient deficiencies, overnutrition is increasing globally. 'if the prevalence continues to increase by . percent per year, adult obesity will increase by percent by , compared to the level' (fao et al. : ) . obesity is an important element of the triple burden per se, with great significance as a contributory factor to a range of noncommunicable diseases (ncds), which are targeted not in sdg but in sdg 'health and wellbeing'. it is unfortunate that diet-related interlinkages with ill-health are not explicit in sdg , and that ncd targets are separated from sdg , given conclusive evidence from global burden of diseases studies of the interconnections between undernutrition and overnutrition. policies should simultaneously address both dimensions to be effective (the lancet ). traditionally the agricultural sector has responded to food insecurity by increasing the production of cheap, high calorie staple foods. recently, some have argued against 'staple grain fundamentalism' and advocated for more research, inter alia, on 'micronutrientrich' foods such as fruits and vegetables to achieve food and nutrition security (pingali ; krishna bahadur et al. ; pingali and abraham ; sanchez ) . sanchez ( ) recommended a major shift in research priorities 'from non-nutrient-rich' foods, including cereals, to 'nutrient-rich foods ' (p. ) . considering the global extent of micronutrient malnutrition, renewed efforts to combat micronutrient deficiency diseases is necessary. however, such efforts should be in addition and not instead of a continued focus on cereal foods. so far, only some have argued for a balance in research to meet increasing demand for both staple crops and for nutrient-rich foods (zhou and staatz ) . this viewpoint signals the need to nudge the agri-food and nutrition policy paradigm. it aims to add missing dimensions to the efforts of the agri-nutrition community of national and international researchers, funders and implementing organizations who are working towards and beyond the sdgs to tackle the 'triple burden' of malnutrition and also the pandemic of diet-related ncds. we reflect on the shifting nature of concepts and priorities for agriculture and nutrition research and development programming. we suggest that faster progress towards nutrition, food security and diet-related health targets hinges, in part, on embracing a set of challenges beyond micronutrient malnutrition and sdg 'zero hunger' (byerlee and fanzo ; fanzo ) . in particular, there are unexploited opportunities through increasing availability of, and access to, healthy foods derived from cereals, specifically maize and wheat, and through enhanced crop qualities. benefits would include reductions in diet-related ncds such as cardiovascular diseases, cancers, diabetes and chronic respiratory diseases, through assuring intakes of bioactive food components (section . ), in particular dietary fibre (section . ), of which cereals are a rich source. other cereals are important in global diets, including rice and so-called 'minor' grains and 'speciality' grains, but are beyond the scope of this viewpoint. we also suggest further analysis of the interrelationships between public and private food policies and strategies, food processing, and consumer behaviour and preferences that will lead to better manufactured products, and more precise public interventions and health outcomes. these are proper concerns of the national and international agri-nutrition communities. research in agriculture and nutrition has changed over the decades. reviews of agricultural development, food security and nutrition reveal several shifts since the middle of the th century (levinson and mclachlan ; the world bank ; nomura et al. ; gillespie and harris ; harris ) . since the s, agricultural development has maintained a strong orientation towards increasing the supply of staple food crops, reflecting concerns over global population increase and the ability of food production to keep pace (byerlee and fanzo ) . the aim was to expand and secure production of cheap, energydense foods which were acceptable to consumers-as an input for food-and farmers-in terms of their willingness to produce. food research interests and commercial investments have diversified over the years to include sustainable development and climate change adaptation, but the overall public policy orientation has continued to focus on agricultural production as a supply of food to urban areas and a generator of income and export revenues. while investments in staple crop production are generally considered to have been a success, only recently has research addressed nutrition, health and the transformation of food systems. reviewing experience from the s, a report for the world bank ( : ) commented that 'both the fields of agriculture and nutrition have lacked unified zeal for addressing nutrition problems explicitly through food over the past several decades' (p. ). on the disciplinary disjuncture between agriculture and nutrition, hitherto, '… ownership of nutrition issues has been limited in agriculture, and emphasis on food has been low among nutritionists' (the world bank : ). fan et al. ( ) have suggested that in the development of agrinutrition thinking, 'the early s seemed to signal a turning point' (p. ). micronutrient deficiencies are now widely recognised to be as important, if not more important than undernutrition. jonsson ( ) , who traced the 'paradigm shifts' in public health nutrition from , noted that the 'micronutrient paradigm' prevailing at the time of writing began in . ridgway et al. ( ) have referred to the nutrition science, guidance and policy changes since the early th century as 'paradigm shifts' in public health. similarly, rifkin ( ) has critiqued the thinking about primary health care, and highlighted the undue attention given to 'microcosms' (meaning 'a narrow and siloed focus' on health) 'that block the critical importance of viewing improvements in health in the much wider environment of social, political and economic contexts' (p. ). both ridgway et al. and rifkin frame their paradigmatic arguments within kuhn's 'the nature of scientific revolutions' ( ) . over the last two decades, discussions at the intersection of agriculture and human nutrition and health have gathered momentum. in , harvestplus was established within the cgiar to advance research and deployment of biofortification, and work intensified on staple food crops to address common forms of micronutrient malnutrition (nestel et al. ) . the more recent shift towards sustainable food systems acknowledges changing patterns of consumption, variously towards animal-source foods, and towards vegetarianism and veganism, waste reduction, a circular food economy and reducing the environmental footprint. these factors and others are implicated in the search for 'sustainable and healthy diets' (fanzo ; fao and who ) . the 'food systems' paradigm recognises that food and health are fundamental in all ecosystems (a nh ). the definition of desired food system outcomes has been broadened and sharpened: 'nutritional security has now emerged as the central issue in world food production as well as the key link between food security and human health. nutrition security occurs when availability, access and stability not only refer to calories, but also to proteins, fats, fibers and micronutrients' (sanchez : ). the high level panel of experts on food security and nutrition of the committee on world food security (hlpe ) advocates adding two additional elements to the four pillars of food security (availability, access, utilization and stability), being 'agency' (individual and group), and 'sustainability' (economic, social and environmental) . researchers have also advocated incorporating 'nutrition-sensitive' elements-specific nutrition goals and targeted interventions-into agricultural development programming (jaenicke and virchow ) , into agrifood policies (gillespie et al. ) and into value chain development (allen and de brauw ; gelli et al. ). these discussions have downplayed the contribution of cereals in alleviating food and nutrition insecurity among the most vulnerable population groups. the causes of malnutrition are complex, involving multiple disease conditions, inadequate water, sanitation, hygiene, and care practices, and a range of basic causes at the societal level (unicef ) . agrinutrition research on improving diets targets adequate intakes of vitamins and minerals (gillespie and harris ) , and the 'triple burden' of hunger, micronutrient malnutrition and overweight/obesity. according to the global nutrition report (development initiatives ), 'among children under years of age, . million are stunted, . million are wasted and . million are overweight. there are . million obese adults' (p. ). obesity is a global problem, a 'ticking time bomb' with major current and future adverse health and economic impacts, coexisting with hunger/undernutrition and hidden hunger/micronutrient deficiency (popkin et al. ) . based on data in shekar and popkin ( ) , at the time of writing it can be said that probably half the world's adults are overweight or obese, threequarters of whom live in low-and middle-income countries. shekar and popkin outline the range of public health interventions that, based on diverse country experiences, have significant potential for addressing obesity: fiscal and regulatory controls of industry conduct; food systemwide interventions through agricultural research and food production and manufacturing, subsidies, infrastructure and logistics; and education and early child-hood interventions. the global nutrition report also referred to diet-related ncds, but the siloed nature of some agri-nutrition thinking exhibits limited interest beyond energy provision and fortification programmes in the dietary and health contribution of the cereals. nevertheless, cereals form the major part of the actual diets of the urban and rural poor. this implies an incomplete agenda for steadfast advancement towards development goals. the 'triple burden' itself has come under scrutiny by scrinis ( ) who argues that the concept abstracts from a complex phenomenon that has social as well as biological dimensions. it is a fragmented framing of the problems, and results in fragmented research and policy proposals. arguably, the triple burden focuses attention on proximal indicators or objectives (underweight, stunting, wasting, and overweight/obesity). the ultimate objective of good nutrition should be healthy lives and wellbeing, including freedom from physical and mental disease-of which there are multiple and complex causes-and specifically from diet-related ncds-which also have non-diet-related causes. child stunting is a principal indicator of nutrition insecurity and micronutrient malnutrition, attributable to deficient maternal and infant diets, and affecting the poor disproportionately (arimond and ruel ; unicef ; smith and haddad ) . since black et al. ( ) it has been clear that maternal and child malnutrition, evidenced in childhood stunting, contribute significantly to the global disease burden. stunting incurs huge intergenerational health, economic and social costs. many international organisations recognize stunting as the major challenge: the world bank highlights stunting ( ); prominent indicators for the child nutrition programme of usaid are stunting and wasting of under-fives (usaid ); the gates foundation strategy on nutrition acknowledges the importance of 'hidden hunger', or micronutrient malnutrition (bmgf ); the european union action plan on nutrition directly targets stunting (european commission ); the uk global challenges research fund (gcrf) addresses global issues faced by developing countries, among which stunting is a major theme (ukri ). interventions now commonly advocated are micronutrient focused, malnutrition-preventative food-based approaches rather than clinical, curative 'therapeutic' interventions still favoured by some ministries of health (thompson and amoroso ; fao and fcrn ; poole et al. ; gelli et al. ) . the dependence in nutrition metrics on stunting as an indicator is indisputably important, but it is one measure of overall food and nutrition security. for children suffering severe acute malnutrition, other childhood conditions often attributable to (maternal) malnutrition, such as low birthweight, also have long-term consequences for the chronic disease burden (briend and berkley ; lelijveld et al. ). leroy and frongillo ( ) have acknowledged that stunting-or 'linear growth retardation'-has become a widely-used and useful tool. they argued that stunting is associated with, but does not cause, the health correlates of linear growth retardation, except for a causal relationship with difficult births and poor birth outcomes. brown et al. ( ) reviewed empirical studies which examined factors associated with child malnutrition, focusing on the three major indicators of malnutrition, being wasting, stunting and underweight. they noted that stunting was the common indicator, and that wasting was relatively understudied. a danger of emphasising a single indicator such as stunting, and associated targets, is the tendency to reduce the multiple dimensions of complex or 'wicked' problems, like poor nutrition and health, to simple solutions, like more micronutrients. just as the conditions for food security and good health cannot be reduced to good nutrition, good nutrition in turn cannot be reduced to an adequate micronutrient intake. fao et al. (fao et al. ) take a comprehensive view of the nutrition challenges, noting that 'diets of poor quality are a principal contributor to the multiple burdens of malnutrition-stunting, wasting, micronutrient deficiencies, overweight and obesity and both undernutrition early in life and overweight and obesity are significant risk factors for ncds. unhealthy diets are also the leading risk factor for deaths from ncds. in addition, increasing healthcare costs linked to increasing obesity rates are a trend across the world' (fao et al. :xxiii) . however, this misses a potential benefit from clear communication to a concerned wider audience, by referring to sdg only in terms of health costs, and not the critical targeted reductions in ncds. there is an abundant literature which links diverse diets to provision of the vitamins and minerals that prevent 'hidden hunger' and micronutrient deficiency diseases (jones et al. ; pellegrini and tasciotti ; baudron et al. ; dulal et al. ; nithya and bhavani ; komatsu et al. ; rosenberg et al. ) . dietary diversity is a proxy for nutrient adequacy (fao ) and is inferred from estimates of the nutrient content and frequency of consumption of foods from different food groups, elicited through individual and household surveys (zezza et al., ; ruel, a; wfp, ) . we are learning more of the gaps in rural and urban populations in terms of access to more diverse diets, i.e., those richer in fruits and vegetables, and about less-nutritious patterns of consumption of processed foods and beverages (penny et al. ; law et al. ; bren d'amour et al. ) , and the differential distributional impacts of temporal, spatial and socioeconomic dimensions of local food environments (duran et for vulnerable populations, increasing consumption of 'nutrient-rich foods' can be achieved through multiple strategies, including ownfood production among the rural poor, better incomes, and enhanced market availability and access for all consumers. nevertheless, we are also learning more about specific barriers to adoption of better diets, for example, the complexity of linkages between agroecological, economic and social systems and education, and cultural barriers including food taboos on maternal behaviour patterns and infant and young child feeding practices (klassen et al. ; chegere and stage ) . the outcome of dietary diversity assessments is often the food consumption score (fcs) (wiesmann et al. ; arimond et al. ; kennedy et al. ). the fcs is constructed by using weightings based on estimated nutrient content at the food category level. the weightings are crude estimates of the nutritional value of different food groups. revision of the food consumption score nutritional quality analysis guidelines (fcs-n) (wfp ) has introduced a more disaggregated food list which discriminates nutrient-rich foods from other less nutrient-rich items belonging to the same food group. dietary diversity scores have been found to be sensitive, robust, valid and cheap-tomeasure indicators of micronutrient intake adequacy in many contexts (headey and ecker, ; nithya and bhavani, ; ruel, ; zhao et al., ; wiesmann et al., ) loose application of protocols may be partly responsible for varying results of studies investigating the association between indicators of dietary diversity and nutritional status. a systematic review of the use and interpretation of dietary diversity association in studies between and by verger et al. ( ) found wide variation among the study characteristics in respect of the unit of analysis, the location, study design, sample size, choice of indicators and analysis of the dietary diversity data. the results showed inconsistent use of protocols and misleading data interpretation within the sample. they also criticised the lack of comprehensiveness of the food items included in food groups across datasets. overall, we need to revise the conceptualisation of food types in dietary diversity studies for various reasons. two areas are raised here for wider discussion: mis-categorisation and missing nutrients. an aggregation problem is that heterogeneous foods are included within a single category. for example, different meats and other foods based on animal-source products have varying nutritional qualities; vegetables and fruits differ considerably in the micronutrient content; fortified (orange) sweet potatoes are categorised with orange vegetables rich in vitamin a, whereas fortified (yellow rice) is not so distinguished; nor are other bio-or industrially-fortified products so distinguished . in particular the single 'staples' category of cereals and tubers includes numerous diverse foods. they are derived from a wide range of crops which exhibit inherent between-species differences. they also often exhibit different within-varietal nutritional qualities attributable to plant breeding and varying production systems and conditions. from these staples many foods are derived through processing and manufacturing that alter nutritional quality for better-by improving acceptability and digestibility-and for worse-by stripping out valuable nutrients and adding noxious components. through ultra-processing into other forms-such as products high in saturated fats, sugar and salt-they can be nutritionally harmful, obesogenic and contribute to ncds (who, b). another issue with measures of dietary diversity is the categorisation of the macronutrients (fats, carbohydrates and proteins) and micronutrients. the measures do not differentiate among, or include all, essential vitamins and minerals which are epidemiologically significant; nor essential fats-or more precisely, fatty acids; nor essential amino acid content and hence protein types. the fcs-n ignores some nutritional deficiencies including those that are context-specific to national, regional (within country) and even local levels (who, a). zinc, iodine, folic acid and vitamin d deficiencies would be examples. moreover, there is a significant omission of the many components of foods that are 'bioactive substances' and contribute to health (weaver ; perez-gregorio and simal-gandara ; sanchez ). the health-promoting bioactive food components ('biofocs') are not included in the dietary diversity discourse and are largely absent from the agri-nutrition literature, but their significance is recognised in biomedical research, food sciences and within the food industry (section . ). dietary diversity as conceived is an essential but partial approach to combatting food insecurity. there is a particular dilemma when overt hunger due to insufficient food calories is an immediate population and policy concern, and where energy needs are paramount (harris ) . more comprehensive dimensions of food insecurity such as the integrated food security phase classification (ipc) are used in humanitarian contexts. in their deconstruction of the meaning of 'famine', maxwell et al. ( ) critique the ipc which assesses famine in five phases, the indicators for which use data on food consumption (or hunger), changes in livelihoods, prevalence of acute malnutrition, and mortality. they argue, inter alia, that the ipc gives a 'mono-dimensional view' of a phenomenon that is multifactorial. even so, the set of ipc indicators captures a wider range of health drivers and outcomes than does the focus on dietary diversity and stunting. it also links to sdg and targets for reductions in infant and child mortality and ncds (united nations, b). the argument thus far is for agri-nutrition research to open up to a broader perspective on the nexus of agriculture, food, nutrition and health. at the heart of this complexity is acknowledgement that foods contain more than the conventional macro-and micronutrients, and that agri-nutrition research should address the nutrition and health requirements for all the essential biofocs. only relative to other 'nutrient-rich' foodstuffs are cereals 'nutrientpoor'. this terminology reflects the emphasis on micronutrient malnutrition. most cereals provide varying amounts of proteins, fats, minerals and vitamins, in addition to being important sources of dietary energy. wheat contributes some % of the total dietary calories and proteins globally (shiferaw et al. ) , rice contributes % of global calories and contains important minerals, vitamins and bioactive phytochemicals with other essential food components found in rice bran (fukagawa and ziska ) ; maize is a staple of over billion people for whom the grain energy contribution to the diet can exceed %. whole maize grain is rich in anthocyanins with many nutritive properties which can be enhanced by the traditional process of 'nixtamalization' ( qualities of cereals are amenable to improvement through traditional plant breeding, genomic selection, bio-and industrial fortification (mattei et al., ; palacios-rojas et al., ; shewry and hey, ; velu et al., ; yu and tian, ; zhao et al., ) . however, the micronutrient content of cereals-based foods is also often reduced through processing methods (suri and tanumihardjo ) . cereals are the dominant source of carbohydrates in the global diet, providing essential food energy. energy matters universally, but has particular importance when minimal energy needs are not being met. persistent humanitarian situations come to mind due to natural disasters such as famines and floods, and anthropogenic disasters such as conflict. across the rural south and under seasonal conditions of hardship and hunger, cereals provide necessary bulk and energy for the poor and those involved in physical work. carbohydrates are a complex and contested nutrient. several classification systems are used currently (ludwig et al. ) . some adverse health reactions to carbohydrates in cereals are well-documented: for example, specific components of wheat affect people with coeliac disease and wheat allergy (brouns et al. ) . regarding starch, a high glycaemic response is known to have adverse effects on diabetes and obesity. however, a higher amylose content compared with amylopectin decreases digestibility, postprandial glycaemia and insulinaemia, and hence can reduce the glycaemic index of carbohydrate foods. a series of systematic reviews and meta-analyses of prospective studies conducted on carbohydrate quality and human health by reynolds et al. ( ) concluded that higher intakes of df or whole grains were likely causally associated with reductions in the risk of mortality and in the incidence of a wide range of ncds and risk factors. in light of the popular concerns about starchy food intakes, they found less evidence for the potential benefit of a low glycaemic index or low glycaemic load diets. nevertheless, processed 'whole grain foods' may not have the same health benefits as unprocessed whole grains, and some 'whole grain foods' which contain added 'free' sugars probably have adverse implications for health (ludwig et al. ). in addition, there is a popular and simplistic misconception that avoidance of cereals, particularly wheat, reflects a healthy lifestyle (igbinedion et al. ) . it is often difficult to disentangle food science and policy from food populism and marketing, whose concerns 'have generally not been substantiated by detailed scientific review' (shewry : ) . according to the uk sacn ( : ), 'total carbohydrate intake appears to be neither detrimental nor beneficial to cardio-metabolic health, colorectal health and oral health… there are specific components or sources of carbohydrates which are associated with other beneficial or detrimental health effects'. thus, it may be the balance of carbohydrate qualities as well as overall energy intake that determines effects on chronic disease and health outcomes (ludwig et al. ; reynolds et al. ) , although this view is contested. there are other components of foods that, puzzlingly, are not invariably considered to be 'true' nutrients but yet are essential for healthy diets: 'other components of food that are not technically "nutrients" also contribute to nutrition and health, such as fiber, probiotic bacteria, and phytonutrients' (the world bank : ). these collectively are 'bioactive food components' (biofocs): dietary fibre and other biofocs that are not energy, protein, fats, minerals, vitamins and water are handled in many different ways by different authors and authorities: 'non-nutritional, but biologically-active substances [include] toxins and contaminants, such as alkaloids and aflatoxins, which are detrimental to health, as well as constituents, such as phytochemicals, that may be health-promoting' (webster-gandy, ). in , the us offices of disease prevention and health promotion, public health and science, and health and human services solicited comments on a proposed definition of biofocs because: 'foods provide numerous chemical constituents that may influence health and disease prevention, in addition to those usually characterized as essential nutrients. the physiological implications of these food components have been the subject of recent scientific inquiries and publications. widespread scientific, governmental, and consumer attention to these components, referred to here as ''bioactive food components,'' has sparked an interest about how they should be defined and how best to evaluate their significance in promoting health and disease prevention. bioactive food components exist not only in commonly consumed foods but also as ingredients in fortified foods and dietary supplements' (federal register : ) . examples of bioactive compounds include carotenoids, flavonoids, phytosterols, glucosinolates, and polyphenols. since vitamins and minerals elicit pharmacological effects, according to gökmen ( ) they also can be categorized as bioactive compounds. bioactive compounds are found naturally in various foods, and have beneficial antioxidant, anticarcinogenic, anti-inflammatory, and antimicrobial properties. some naturally occurring substances and others introduced during food manufacturing, such as acrylamide in bakery products, may also have adverse effects (gökmen ) . most of the beneficial effects of the consumption of wholegrain cereals on ncds are currently attributed to the bioactive components of dietary fibre and a wide variety of phytochemicals (bach knudsen et al. ). there is much research into the bioavailability and bioaccessibility of such active compounds and nutrients, as well as macronutrients such as carbohydrates, by the food processing industry as well as academic researchers, not least the use of nanoemulsions as vehicles for bioactive compounds to improve the sensory, nutritional and health properties of processed foods (mahfoudhi et al. ; leong et al. ; santos et al. ) . our interest here concerns the mainly naturally-occurring substances in foods that are beneficial or essential to nutrition and health. these biofocs are known to prevent and combat health conditions comprehended by sdg , target . 'to reduce premature mortality from non-communicable diseases' (united nations, b). because biofocs such as fibre and phytochemicals, like proteins, minerals and vitamins, are also found in cereal foods, it is a mistake to classify cereals automatically and universally as 'nutrient-poor'. research on biofocs seems to be largely siloed in biomedical and food science disciplines and discussions of functional foods, in the same way that, it is argued, nutrition is siloed from agri-food sustainability (el bilali ). bio-focs are, however, present in popular health media (brouns et al. ; duyff ) . the literature on biofocs is abundant, the science is complex, and this viewpoint can only summarise the field. here we acknowledge cereal carbohydrates not only as important source of energy, but also as a source of diverse biofocs and in particular, of dietary fibre (df). the dietary and health impacts of carbohydrates are summarised in fig. . simply put, carbohydrates provide energy through digestion of sugars, starch and oligosaccharides in the small intestine. some carbohydrates also create a glycaemic response with adverse effects on, for we thereby differ from the us office of dietary supplements' view which defined bioactive compounds as 'constituents in foods or dietary supplements, other than those needed to meet basic human nutritional needs, which are responsible for changes in health status ' weaver, c.m. ( ) . bioactive foods and ingredients for health. there is now a good understanding of the physiology, biochemistry, and metabolism of most carbohydrates (reynolds et al. ) , and of the importance of df in disease prevention (cummings and engineer ) . stephen et al. ( : ) give an account of df intake, types and dietary sources, and the relationships with numerous ncd risks. these include improvements in all-cause mortality, cardiometabolic health and risk factors including hypertension, hyperlipidaemias, type diabetes, obesity in terms of both energy intake and appetite effects, gastrointestinal health including faecal weight and constipation, diverticular disease, oesophageal disease and a range of cancers. broad guidelines for df intakes exist in national and international nutrition policies but dietary guidance still focuses on topics other than fibre (stephen et al. ) , with the level of detail lagging that for vitamins and minerals (see section . below). in fact there is little in the who fact sheet on the role of df: only '… many people do not eat enough fruit, vegetables and other dietary fibre such as whole grains… eating at least g, or five portions, of fruit and vegetables per day reduces the risk of ncds and helps to ensure an adequate daily intake of dietary fibre' (who ). in a review of european countries, we learn about diversity in df sources, consumption and recommendations: 'grain products provide the largest proportion of fibre in the diet for all countries studied, with bread by far the largest grain source, with smaller contributions from breakfast cereals, pasta and biscuits and pastries. vegetables, potatoes and fruits also contribute substantially, but these vary more widely from country to country, depending on climate and cultural norms. recommendations about types of fibre to consume are therefore difficult as "not one size fits all"' (stephen et al. : ) . processing also affects the nutritional quality of grains, and differences have been identified between the quality of processed grains and of fibre added to manufactured foods compared to naturally occurring df within whole grain foods (slavin ; reynolds et al. ). dietary guidelines are political tools for promoting healthy consumption patterns 'and can also serve as the basis for developing food and agriculture policies' (muka et al. ; fao and fcrn :v) . new research reported by herforth and masters ( ) reviews methodologies, approaches and metrics for estimating the affordability of nutritious diets around the world. a proposal to harmonise nutrient reference values could introduce new rigour to dietary guidelines , and new analytical tools for estimating human nutrient requirements are becoming available (e.g., schneider and herforth ( ) ). dietary advice about the consumption foods such as of whole grains rich in df is not uncommon, but quantitative guidelines are unavailable for many countries, and details are often incomplete (herforth et al. ). in particular, gaps persist on the quality of df essential to meet dietary recommendations (stephen et al. ) . the relative inattention given to df and other biofocs is significant for agricultural sciences research. weaver ( ) has commented that because bioactives are of increasing interest, more research is needed to understand the complex relationships between individual food components, foods, and the biological effects, thus providing better evidence to inform dietary guidelines. a balanced, comprehensive and more thorough understanding of the contribution of carbohydrate-rich cereals to diets in respect of under-nutrition, overnutrition and ncds will likely alter dietary research and guidelines. all evidence hitherto points towards consumption of more fibre and more whole foods, including cereal grains. springmann et al. ( ) found that in all fao-defined geographical regions, with the exception of north america, current intakes of whole grain foods should at least double compared with national dietary guidelines, and in the cases of who and eat-lancet guidelines, increase by % and % n. poole, et al. food policy xxx (xxxx) xxxx respectively. adoption of dietary guidelines would lead to major reductions in the global burden of diet-related ncds through increasing consumption both of cereals rich in df, and necessarily of fruits, vegetables, pulses, nuts and seeds rich in both micronutrients and df. new knowledge is needed specifically of df: '[the uk scientific advisory committee on nutrition] sacn would welcome research to improve the functional categorisation of specific dietary fibres and relevant extracts: building structure-function understanding to link and predict from defined, measurable physical and chemical properties to specific physiological effects. this should include defining physiologically meaningful effect ranges for colonic and faecal ph, short chain fatty acids, and bacterial populations' (sacn : ) . concern about the sustainability of agriculture and diets is not new (reynolds et al. ; tilman and clark ) , and has received new impetus. the eat-lancet commission reference diet was 'based on the best evidence available for healthy diets and sustainable food production' (willett et al. : ) , using food groups plus added fats, sugar, salt, and other dietary constituents. grains were recognised therein as the principal source of energy in global diets, with whole grains and fibre from grains associated with reduced risk of coronary heart disease, type diabetes, and overall mortality. the formulation of model sustainable diets that are affordable by the global poor in different food cultures is still pending (hirvonen et al. ; willett et al. ; drewnowski ) . using data, a leastcost eat-lancet commission healthy diet formulated according to local food preferences and availability has been found to be unaffordable by billion people globally . for india, sharma et al. ( a) have illustrated how diets across local and national geographical dimensions and socio-economic levels deviate significantly from the eat-lancet reference diet. economic modelling suggests that increasing the supply of fruit and vegetables to meet the who's dietary recommendation of g/person per day is for many countries unlikely by the year (mason-d'croz et al. ). therefore, assuring diverse diets incorporating nutrientrich foods is not a trivial matter. this suggests the need for more research into how, in diverse food cultures and seasons, intakes of cereals and other fibre-rich foods such as pulses, can complement 'nutrientrich' foods to meet revised dietary recommendations. fao and who ( ) and the hlpe ( ) have recommended moving towards context-specific 'territorial diets' based on locally available, economically accessible, and culturally acceptable foods, delivered through sustainable systems. cereals, for energy and much more, will be the foundation of such diets. understanding the nutritional requirements for df and other bioactives adds a new dimension to the continuing agenda for optimising plant breeding and production conditions for best nutritional outcomes in uncertain and changing climates. increases in crop productivity are necessary in many countries and challenging contexts. bloom et al. ( ) offer various explanations for their estimation that research productivity generally has fallen during the past years. for agricultural research, they have calculated a negative annual growth rate in agricultural productivity both for the united states and globally. but in summary, the finding is robust that 'ideas are getting harder and harder to find' (p. ) and that considerable increases in research investment are needed to maintain gdp growth rates. a major task is to redress the significant yield gaps in crop productivity between many african countries and other regions. investment by the international community in local capacities to address local conditions is essential. a recent report critical of the agra programme shows that there is no consensus on the merits of a "green revolution" approach to agricultural intensification, and that the evidence of poor impact impels exploration of alternative models of sustainable crop production for food and nutrition security among the poor in africa (bassermann and urhahn ) . moreover, greater collaboration among international and national cereals researchers is necessary, in order for wheat and maize scientists to share lessons learned with the other major cereal sector, rice, and with 'minor' cereals which are also very important regional food crops, with many advantages of local adaptation, resilience and nutritional quality. soil characteristics and production systems affect crop macro-and micronutritional qualities for human consumption (herencia et al., ; kihara et al., ; lovegrove et al., ; shewry, ; shewry and hey, ) . more local knowledge is needed. there is also considerable potential for plant breeding strategies to improve grain composition through exploiting natural variation, genomic selection, mutagenesis and transgenesis, improving cereal cell wall polysaccharides, and specifically improving the starch composition and structure through natural and induced mutations: 'in recent years the manipulation of the amylose-amylopectin ratio in cereals [maize, rice, wheat and barley] has been identified as a major target for the production of starches with novel functional properties and improved health benefits' (lafiandra et al. : ) . programmes of biofortification of seed varieties and industrial fortification of processed products are proven and should be continued, accompanied by efforts to integrate biofortification into public and private policies, programmes, and investments, and to evaluate and enhance consumer uptake (bouis and saltzman ; bouis ) . similarly, programmes of industrial fortification of cereal products should be expanded, considering how to overcome the obstacles to fortification programmes where flour is derived from local milling rather than industrial-scale processing (ansari et al. ; poole et al. ) . the loss of nutritional quality through processing is a major challenge. public sector food policy still allows the food industry to mill away much of the nutritional content of cereals and to create ultraprocessed foods (upfs). these often contain noxious qualities and components, and contribute directly to the huge and increasing global health and economic costs of ncds (monteiro et al. ; vandevijvere et al. ) . agricultural scientists and socioeconomists should collaborate with food scientists in order to enhance the nutritional quality of inputs to the food industry and to assess health claims and assure consumer acceptance of novel or reformulated products. collaboration between cereal scientists and industry food scientists are also needed to improve processing and develop innovative technical approaches to overcome the spoilage of fats in whole grain foods, and achieve the effective substitution of 'free' or added sugars that have adverse health effects. overall, we need a reorientation of food manufacturing towards processes and products that enhance the nutritional contribution of cereal foods rather than over-processing which strips out the nutritional content, adding instead the noxious components. in plant breeding and metabolic studies together, as well as cereal processing and manufacturing, further research is needed to elucidate the relationship between dietary components of cereals and cereal foods, and glycaemia/insulinaemia that underlies some of the critical increase in ncds. new metrics have been proposed to assess the dietary quality of carbohydrate-rich foods in respect of calories and other macro-and micronutrients which should generate enhanced dietary guidelines, promote novel and healthy foods, increase the accuracy of product labelling, and reduce consumer confusion about nutritional qualities (liu et al. ). food safety is one dimension that spans the whole food system and n. poole, et al. food policy xxx (xxxx) xxxx demands diverse but coherent technical, commercial and policy responses. as an example of the food safety challenges to nutrition and health from cereals, mycotoxins are an important agent. for cereal systems, aflatoxicosis is a common health hazard in africa, first identified in the s. aflatoxins in maize can develop in the field, causing ear-rot, and in the absence of field contamination, during post-harvest grain processing and storage (council for agricultural science and technology ). a systems approach to food safety in the maize sector was recently designed and implemented in kenya, funded by the cgiar research program on agriculture for nutrition and health (an h) (paca, no date). results suggested that testing procedures throughout the maize value chain could enhance food safety from aflatoxin poisoning for million kenyans (hoffmann ). recommendations included 'the adoption of coregulation that is a governance option that uses government-backed standards adopted by industry, leading to shared responsibility to manage aflatoxin risk in kenya and elsewhere in the region' (herrman et al. : ) . hence the importance of collaboration with farmers and with private sector firms such as maize millers (fisher et al. ; pretari et al. ) . post-harvest losses are known to account for a major part of global food production. food waste is a serious threat to narrowing the gap between supply and demand (mason-d'croz et al. ). the causes of losses persist throughout the food system and in low-income countries are mainly connected to financial, managerial and technical limitations in harvesting techniques, storage and cooling facilities in difficult climatic conditions, infrastructure, packaging and marketing systems. given that many smallholder farmers in developing countries live on the margins of food insecurity, a reduction in food losses could have an immediate and significant impact on their livelihoods. food systems improvements may not necessarily be costly or technologically advanced. recent research on combatting losses in tanzania, mainly for maize, found that the use of inexpensive kg hermetic storage bags could reduce infestation by, and losses through, insects and other pests and mitigate food insecurity by % in the lean season for smallholder farmers (brander et al. ) . in this case, disentangling the effects of the technology itself from the effects of training on adoption of new storage technology needs further work, and illustrates the multisectorality of the food systems challenges which constrain good nutrition and health. progress in addressing the nutritional drivers of ncds is largely held up by the twin obstacles of commercial interests and lack of political will (horton ) . current nutritional challenges have much to do with the political economy of food through lobbying of the food industry, with advocacy of civil society, and the need for public regulation of and policies for research and investment, sectoral taxation, prices, subsidies and incentives, and food trade and security policies. the cereal industry is centre-stage in food trade, manufacturing and processing as well as consumption. balarajan and reich ( ) have identified six themes in the political economy of nutrition that highlight current challenges: leadership, intersectoral coordination, accountability, issue framing, hierarchy and demonstrating effectiveness of nutrition actions. agri-nutrition scientists and socioeconomists should participate in this agenda and adopt multidisciplinary approaches, particularly through joint ownership of issues, shared prioritisation, industry engagement, and above all by deploying food systems thinking (gillespie and van den bold ; gillespie et al. ) . the global alliance for improved nutrition (gain) is one collaborative vehicle which aims to increase the availability, affordability and consumption of nutritious and safe foods, and change market incentives, rules and regulations to promote nutritious diets. based on experience in south asia, and the growing literature on public-private sector food, nutrition and health linkages, poole et al. ( ) have identified various ways for researchers to engage in enhancing the delivery of nutrient-rich foods, and limiting the consumption of harmful foods. the prevalence of adult obesity has superseded underweight, both globally and in all regions except parts of sub-saharan africa and asia (development initiatives ). two recent research examples among many illustrate the importance of understanding consumer behaviour in the varying contexts of economic and nutrition transition. in india, like many other countries, the nutrition transition towards obesity is marked by increased sales of processed and packaged foods (law et al. ) . analysing data from a representative sample of take-home purchases of packaged food and beverages by urban indian households between and , they found that purchased quantities per capita lagged those in western economies which have advanced further along the transition except for high levels of consumption of foods such as packaged milk, processed wheat or edible oils. income was not a simple determinant of purchasing patterns. similar health and research challenges have been reported by smart et al. ( ) in sub-saharan africa, where undernutrition and increasing overnutrition are prevalent. investigating the changes in food demand in mozambique, they found that urbanization impels consumption of more nutritious foods and more processed foods at the same time, with both positive and negative impacts on diet quality and implications for health. urbanization and increased consumption of processed foods were significantly and strongly associated with deterioration in diet quality. they conclude that 'as urbanization continues and incomes rise, african cities need to consider what mix of policies and programs might counteract the negative effects we see from both these factors on diet quality' (p. ). such findings imply more social science analysis of consumer education and behaviour change, not least in favour of whole grain foods, and more political economy analysis which might reduce the production, distribution and consumption of upfs of which cereals, as noted, are often an ingredient (mattei et al. ) . such analysis should cast a light on why knowledge and dietary guidelines have often had limited influence on public nutrition policy and less on actual public health and consumer education and behaviour change . cereal grains such as maize and wheat are used as an input to livestock feed as well as food, offering an indirect route to better (human) nutrition outcomes. maize grain is an important feed source for monogastric livestock, and poultry in particular-and may imply different feed quality needs as compared to food (krishna et al. ) . cereal crops are also grown for forage and crop residues and are an important by-product widely used as feed in the global south (blümmel et al. ; valbuena et al. ) . as sanchez ( ) notes in response to the eat lancet commission, animal-source foods (specifically red meat, poultry and eggs) are a nutritional necessity for hundreds of millions, '…if not billions, of fertile women and children in low-and middle-income countries who in all likelihood need more that the g/ day indicated in the eat-lancet diet' (p. ). here we avoid contention concerning the sustainability of livestock production in general (adesogan et al. ) , and limit ourselves to reiterating the ongoing importance of cereals as an input to livestock production, in order to meet the nutritional needs of vulnerable populations. it has been argued that agricultural research, by concentrating on staple cereals, has not responded adequately to persistent micronutrient malnutrition and child stunting, and increasing overweight and obesity (pingali ; pingali and abraham ). sanchez ( ) supports n. poole, et al. food policy xxx (xxxx) xxxx work on nutrition-sensitive food systems and nutrition security in terms of availability, access and stability of calories, proteins, fats, fibre and micronutrients. now is also the time to reiterate the contribution of cereals beyond energy, particularly whole grains, to nutrition and health. the challenges enumerated in the previous (section . ) are by no means exhaustive and will require comprehensive and collaborative approaches to maximise the dietary contributions of cereal foods. admittedly, a comprehensive approach and multidisciplinarity exacerbate the operational challenges for many policy and research organisations, national and international, which have struggled hitherto to integrate thinking about nutrition security, rather than just food energy security, into agricultural research. this suggests new research partnerships between agricultural scientists, nutritionists, biomedical and food science researchers and socio-economists, and more support from the international community directed towards under-resourced national agricultural and nutrition research communities. understanding of carbohydrate components of foods from field to plate, and on to digestion, fermentation and metabolism is needed. ludwig et al. ( ) identify a number of 'carbohydrate controversies' that need further research, including those related to the contribution of whole grains and df to diets, health and wellbeing. a focus on stunting and the 'micronutrient malnutrition paradigm' is unduly narrow and siloed. micronutrient malnutrition is, to use rifkin's term, a 'microcosm' ( ), rooted in a constrained definition of 'nutrient' that does not take into account the many other essential food components. it blocks 'the critical importance of viewing improvements in health in the much wider environment of social, political and economic contexts' (p. ). wells et al. ( ) embrace a wider biological approach to nutrition: ''the concept of malnutrition should also incorporate the gut microbiome, representing millions of genes from microorganisms. the microbiome generates a collective metabolic activity that affects and responds to the human host' (p. ). moreover, the 'triple burden' concept implies addressing not just sdg but also the ncds cited in sdg , and it is important to communicate this concern to a wider readership. use of the term 'non-nutrient components of foods' (the world bank ) is a misnomer: should not df be classed as a nutrient? just as there is a case for modernising the definition of protein quality (katz et al. ) , so may there be also a case for redefining nutrients in terms of df and other naturally-occurring food components that takes into account the nuanced and net effects on health of a wide range of bioactive compounds. meanwhile, 'biofocs' will serve the purpose for those substances that are essential to nutrition and health. and that implies new research on cereal foods, carbohydrates and df. we need to build knowledge about production factors affecting df, phytochemicals and other biofocs in major and minor cereals (gołębiewska et al. ) . distinction should be made among naturally-occurring substances and contaminants, industrial supplements and additives, and those which are beneficial or harmful (yasmeen et al. ( ) . to do so is beyond the scope of this viewpoint. agri-food systems thinking provides a robust platform for reshaping the agri-nutrition research agenda and to incorporate multi-disciplinary partnerships. there are ongoing wheat and maize systems research needs, which are to: i) accelerate plant breeding for nutritional quality and biofortified crop varieties, and scale up industrial fortification, both being proven strategies for enhancing the nutrient-intensity of major cereals among other crops (harvestplus ); ii) persist in crop productivity and sustainability research in diverse soil and production conditions and in the context of climate change, especially under the resource-constrained conditions of smallholder farmers (ritzema et al. ; kihara et al. ); iii) enhance practices for processing, manufacturing, storage and distribution of natural, bio-and industrially enriched cereal foods to reduce losses and nutritional harm in terms of both quality and quantity (sharma et al., b) ; iv) understand consumer behaviour at a disaggregated level: livelihood patterns and access to different foods among vulnerable groups, in different cultures, and in different production and marketing systems (haddad ) ; v) identify the inherent contradictions and resolve the trade-offs within cereal food systems concerning environmental sustainability, poverty reduction, profitability for actors and firms throughout the value chain, and improved nutrition and health of vulnerable populations. agri-nutrition and development communities need to embrace a multidisciplinary research agenda that integrates disciplines, goes beyond the nutrition 'microcosm', redefines nutrients and rethinks agrifood cereal systems. this calls for collaboration with other food systems stakeholders to broaden understanding of the nutritional and healthpromoting value of cereals, including preserving and enhancing the nutritional qualities of processed foods, and with consumers, assessing and assuring acceptance of novel and nutritious cereal-based products. research funds are increasingly with foundations and industry rather than traditional publicly-funded bilateral and multilateral donors and development organisations. it is not only because the problems are multidisciplinary and multisectoral that researchers must look for new collaborations: the required level of resources is held by the private sector. hence sdg . it would be pretentious to claim to have identified a kuhnian paradigm shift in agri-food systems for food security, nutrition and health, but we do need a broader and more nuanced understanding of the nutritional and health-promoting value of diverse foods, including cereals. we do not want to question here the merit of researchers and organizations engaged with cereals versus 'nutrient-rich foods'. micronutrients matter but so also do many other food components that contribute to health and wellbeing. we do want future research reprioritization, and the community of researchers, research funders and implementing organizations in agriculture, nutrition and international development to rethink strategies that go beyond vitamins and minerals, specifically to integrate the contribution of dietary carbohydrates and other macronutrients to health and wellbeing. cereals and 'nutrient-rich foods' are complementary in agri-nutrition and require additional research and resources, and increased attention for one should not replace the other. while concentrating on maize and wheat, we acknowledge that many of these considerations apply to rice, the other major cereal crop, and also to so-called 'minor' grains and 'speciality' grains-but detailed discussion is beyond the scope of this viewpoint. in rifkin's words, 'paradigm change depends on people accepting a new interpretation of events and putting in place policies to accommodate this new interpretation' ( : ). as long as the sdgs remain, and beyond, and while food systems drivers are evolving and acute, food security and nutrition research cannot be 'either/or' any of the elements of a comprehensive agri-nutrition agenda. in the covid- pandemic exposes the fragility of global food systems and adds urgency to reshaping the agri-nutrition agenda (development development initiatives, ; global panel ; united nations, a) . among the likely outcomes of the pandemic will be increases in poverty, hunger and malnutrition among the world's most vulnerable populations through reductions in dietary quality, incomes and healthcare provision. the lancet global health considers increasing food insecurity as a result of covid- to be 'an impending natural disaster' (editorial : e ) . with the likelihood that reduced national and international resources will imperil the work of national governments and organisations and the development community, the chances of achieving at least some of the sdgs are retreating beyond . the commitment to food security expressed in the g ministerial statement on covid- highlights the importance of cooperation, efficiency, appropriate support mechanisms and functioning markets 'to help ensure that sufficient, safe, affordable, and nutritious food continues to be available and accessible to all people, including the poorest, the most vulnerable, and displaced people in a timely, safe, and organised manner, consistent with national requirements' (g extraordinary agriculture ministers meeting : no page numbers). the views expressed in this paper are those of the authors and do not necessarily reflect those of any institution. the usual disclaimer applies. nigel poole is currently a visiting fellow, socio-economics program, international maize and wheat improvement center (cimmyt), mexico. jason donovan is senior economist, socio-economics program, cimmyt, mexico. olaf erenstein is director, socio-economics program, cimmyt, mexico. inclusive food system transformations for healthy diets: national experiences with a global challenge animal source foods: 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nutrition sensitivity buy or make? agricultural production diversity, markets and dietary diversity in afghanistan food counts. measuring food consumption and expenditures in household consumption and expenditure surveys (hces). introduction to the special issue improving nutritional quality of rice for human health dietary diversity scores: an indicator of micronutrient inadequacy instead of obesity for chinese children projected demand and supply for various foods in west africa: implications for investments and food policy authors wish to acknowledge the critique and suggestions of reviewers which have helped to shape the final version. we also extend thanks to colleagues who responded to queries about dietary and health effects of carbohydrates and to those who commented on fig. . simplifications, errors and omissions are the responsibility of authors. key: cord- -fzgxuak authors: penman, sophie l.; kiy, robyn t.; jensen, rebecca l.; beoku‐betts, christopher; alfirevic, ana; back, david; khoo, saye h.; owen, andrew; pirmohamed, munir; park, b. kevin; meng, xiaoli; goldring, christopher e.; chadwick, amy e. title: safety perspectives on presently considered drugs for the treatment of covid‐ date: - - journal: br j pharmacol doi: . /bph. sha: doc_id: cord_uid: fzgxuak intense effort is underway to evaluate potential therapeutic agents for the treatment of covid‐ . in order to respond quickly to the crisis, the repurposing of existing drugs is the primary pharmacological strategy. despite the urgent clinical need for these therapies, it is imperative to consider potential safety issues. this is important due to the harm‐benefit ratios that may be encountered when treating covid‐ , which can depend on the stage of the disease, when therapy is administered and underlying clinical factors in individual patients. treatments are currently being trialled for a range of scenarios from prophylaxis (where benefit must greatly exceed risk) to severe life‐threatening disease (where a degree of potential risk may be tolerated if it is exceeded by the potential benefit). in this perspective, we have reviewed some of the most widely‐researched repurposed agents in order to identify potential safety considerations using existing information in the context of covid‐ . taleb-gassabi, & dayer, ) . a standard dose of lopinavir-ritonavir is mg/ mg twice a day for hiv- treatment, and this has also been used for sars-cov- treatment . the most frequent reported aes for lopinavir-ritonavir treatment are gastrointestinal disturbances including diarrhoea, nausea and vomiting (chandwani & shuter, ) . dose-related diarrhoea have been reported in up to % of patients and are thought to occur through a number of mechanisms including decreased proliferation of intestinal epithelial cells, disruption of intestinal barrier function, inducing endoplasmic reticulum stress and activating the unfolded protein response (x. wu, li, peng, & zhou, ) . diarrhoea is also a symptom in some covid- patients and so lopinavir-ritonavir has the potential to exacerbate this. pancreatitis has been reported in a small number of patients following lopinavir-ritonavir treatment although this was more frequent in those with a pre-existing history of pancreatitis (chandwani & shuter, ; oldfield & plosker, ) . additionally, patients with underlying liver diseases should have regular monitoring of hepatic function (palacios et al., ) . caution should be exerted for those patients taking concomitant medication as lopinavir-ritonavir inhibits p-glycoprotein (p-gp) and cytochrome p (cyp) - a , which therefore may alter the pk of other compounds (l. zhang, zhang, & huang, ) . a covid- drug interaction website has been developed by the liverpool drug interaction group which details ddis with lopinavir-ritonavir and a number of drugs, which in some cases can lead to potentially serious and/or life-threatening reactions (group, ; abbvie inc., ) . since the sars-cov- outbreak, clinical trials have been registered (up to th july ) to test lopinavir-ritonavir as a potential treatment for sars-cov- with variable outcomes in terms of efficacy. in one trial of patients with confirmed sars-cov- , patients on the lopinavir-ritonavir arm were withdrawn due to aes . in a different trial, patients who were administered lopinavir-ritonavir ( mg/ mg) also experienced gastrointestinal aes (y. li et al., ) . chloroquine and its derivative, hydroxychloroquine, are widely used as inexpensive and safe antimalarial drugs. in particular, the established good tolerability of chloroquine/hydroxychloroquine has made them safe to use even in pregnancy (villegas et al., ) . in addition to anti-malarial activity, both drugs have immunomodulating effects and are used for the treatment of autoimmune diseases including systemic and discoid lupus erythematosus, psoriatic arthritis, and rheumatoid arthritis. chloroquine/hydroxychloroquine concentrate extensively in acidic vesicles including the endosomes, golgi vesicles, and the lysosomes (ohkuma & poole, ) . this leads to lysosomal membrane permeabilisation or dysfunction of several enzymes including acid hydrolases and palmitoyl-protein thioesterase (rebecca et al., ; savarino, boelaert, cassone, majori, & cauda, ; schrezenmeier & dorner, ) . although the precise mechanisms of the anti-viral effects are not fully understood, it has been proposed that chloroquine/hydroxychloroquine can prevent virus infection (pre-infection) by interfering with the glycosylation of cellular receptors and impair viral replication by increasing endosomal ph (post-infection) (savarino et al., ; savarino et al., ; vincent et al., ) . owing to their efficacy against viruses (mostly demonstrated in vitro) including influenza, hiv, coronavirus oc , and sars-cov, a large number of clinical trials (> ) have been registered worldwide using chloroquine/hydroxychloroquine alone, or in combination with other drugs (e.g. azithromycin) for the treatment of covid- . despite promising in vitro antiviral results for hydroxychloroquine/chloroquine, there is no convincing evidence of efficacy at present (gao, tian, & yang, ; gautret, lagier, parola, hoang, meddeb, mailhe, et al., ; gautret, lagier, parola, hoang, meddeb, sevestre, et al., ; magagnoli, ; mathian et al., ; million et al., ; tang, ; yao et al., ) . a post-exposure prophylaxis randomised controlled trial of participants failed to show any benefit of hydroxychloroquine (n= ) compared with placebo (n= ) (boulware et al., ) . at the time of writing, the recovery trial (clinical trial identifier nct ) which is the largest randomised control trial so far conducted for the treatment of covid, has stopped recruiting to the hydroxychloroquine arm ( patients compared with on standard care) because of no beneficial effect either in terms of mortality or hospital stay (p. . there are still many other trials on-going testing the efficacy of hydroxychloroquine for either prophylaxis or treatment. both chloroquine and hydroxychloroquine have been in clinical use for many years for rheumatoid diseases, and thus their safety profile is well established. dose-dependent retinal toxicity has long been recognized as the major ae with long-term use of chloroquine/hydroxychloroquine (marmor et al., ) . besides retinal toxicity, gastrointestinal, liver and renal toxicity have also been reported (giner galvan, oltra, rueda, esteban, & redon, ; michaelides, stover, francis, & weleber, ; mittal, zhang, feng, & werth, ) . as both drugs are mainly metabolised in the liver and excreted by renal clearance, their use in patients with liver or renal impairment may worsen the function of these organs. for chloroquine treatment, prescribing information recommends the full dose at all degrees of renal impairment but suggests that monitoring of renal function may be useful . for hydroxychloroquine, reductions in dosage are advised for patients with impaired renal function, as well as those taking concomitant medications with known risks of kidney damage (concordia pharmaceuticals inc, ) . this article is protected by copyright. all rights reserved. a serious ae associated with chloroquine/hydroxychloroquine is cardiotoxicity, which can take many forms including cardiomyopathy in rare instances. prolonged treatment or high dosage of chloroquine/hydroxychloroquine has been shown to increase of the risk of qt interval prolongation, polymorphic ventricular tachycardia, and sudden cardiac death (chatre, roubille, vernhet, jorgensen, & pers, ) . a large epidemiological analysis in patients with rheumatoid arthritis has recently shown that -day cardiovascular mortality was increased by more than -fold when hydroxychloroquine was combined with azithromycin. the lethal ventricular arrhythmias are primarily due to inhibition of a potassium channel (the inward rectifier kir . channel) and may occur at low µm concentrations (ic = . m) (rodriguez-menchaca et al., ) . while therapeutic doses of chloroquine typically result in plasma concentrations of - µm, much higher concentrations in the heart are expected based on a -fold increase observed in rat pk studies (mcchesney, banks, & fabian, ; walker, dawodu, adeyokunnu, salako, & alvan, ) . both drugs act on various potassium channels including the inward rectifier currents (kir . and kir . ) and rapid delayed rectifier currents (kv . /herg) (ponce-balbuena et al., ; rodriguez-menchaca et al., ; sánchez-chapula, navarro-polanco, culberson, chen, & sanguinetti, ) . the binding of chloroquine to the inward rectifier kir . channel can be stabilized by negatively charged and aromatic amino acids (rodriguez-menchaca et al., ) . to a lesser extent, chloroquine also blocks the rapid delayed rectifier ikr, possibly through cation-π and π-stacking interactions with tyrosine and phenylalanine in the s domain of herg (sánchez-chapula et al., ) . the effect of inhibition of these potassium channels on the heart rate appears to be complex. however, blocking the herg channel has proven to be the most common mechanisms by which drugs cause qt interval prolongation (traebert & dumotier, ) . the binding of chloroquine/hydroxychloroquine to proteins is also stereoselective, but whether one of the chloroquine/hydroxychloroquine enantiomers has a stronger interaction with the kir . channel is not known. caution is needed when hydroxychloroquine is used in combination with other drugs (including azithromycin), which increase the qt interval because of a pharmacodynamic synergistic interaction. given the comorbidities in many patients with covid- , especially those with underlying cardiovascular disease, and the fact that covid- itself is associated with cardiac manifestations, this may increase the risk of cardiotoxicity associated with the use of chloroquine/hydroxychloroquine. indeed, excessive qtc prolongation was observed in % of patients as reported by bessiere at al. and greater qtc prolongation was also seen in patients taking the combination of hydroxychloroquine and azithromycin than those taking hydroxychloroquine alone, highlighting the importance of pharmacodynamic interactions (bessiere et al., ; mercuro et al., ) . furthermore, a phase iib trial in brazil showed that a higher dose of chloroquine ( mg twice daily) in patients hospitalised with covid- had a higher fatality rate ( %) compared with % in the lower dose ( mg twice daily) group (borba et al., ) . qtc interval prolongation > msec was observed in % of the high dose group compared with % of the low dose group. the us prophylaxis randomised control trial however did not show any increase in cardiovascular aes (boulware et al., ) . we await the publication of the recovery trial to determine whether there was an excess of cardiovascular events. however, it is important to note that despite the size of the recovery trial (n = patients), it may still be under-powered to identify an excess number of cardiovascular events when compared with standard of care. remdesivir is an investigational compound that was developed for the treatment of ebola (mullard, ; tchesnokov, feng, porter, & gotte, ) . remdesivir is a monophosphoramidate prodrug and acts as a broad-spectrum antiviral that can be incorporated into viral rna (agostini et al., ; sheahan et al., ; warren et al., ) . many anti-virals are proving to be ineffective against covid- due to the presence of a proofreading exoribonuclease (exon) specific to coronaviruses, encoded in non-structural protein (nsp ) (agostini et al., ) . remdesivir is able to evade this viral proofreading, meaning its incorporation into viral rna results in the inhibition of rna-dependent rna polymerases (rdrps), thereby preventing subsequent viral replication (warren et al., ) . furthermore, arshad et al. suggest that the maximum serum concentration (cmax) of remdesivir is sufficient to inhibit % of sars-cov- replication, a parameter which is suspected to be of vital importance in the treatment of covid- (arshad et al., ) . remdesivir is administered intravenously, with single doses ranging between to mg being well patients receiving remdesivir via the uk early access to medicines scheme (eams) is similar to that which was evaluated for ebola treatment: a loading dose of mg on day , followed by mg daily for - days depending on symptom severity (medicines and healthcare products regulatory agency, b). as such, it is likely that many of the aes observed in the ebola study will translate to covid- patients treated with remdesivir. this article is protected by copyright. all rights reserved. mild to moderate alt and aspartate transaminase (ast) elevations were observed in several ebola patients during the multiple-dose study, thus reflecting observations made in human hepatocytes in vitro (clinical trials.gov, ; world health organisation, ) . this is likely to be due to the high cell permeability of hepatocytes, in combination with the effective intracellular metabolism of remdesivir to its active form within the liver (world health organisation, ) . emerging data has suggested that sars-cov- may target ace on hepatocytes leading to liver injury as evidenced by a significant increase in alt and bilirubin in severe cases of covid- (guan et al., ) . therefore, it is likely that differentiating between covid- -induced transaminase elevations and those induced by remdesivir presents challenges (bangash, patel, & parekh, ; c. zhang, shi, & wang, ) . however, a recent study found that only . % of covid- patients receiving remdesivir treatment suffered serious (grade or ) transaminase elevations, with there being no significant difference between the remdesivir-and placebo-treated groups (beigel et al., ) . this data implies that remdesivir is relatively well-tolerated in sars-cov- -positive patients. regardless, as advised by the drug manufacturer, daily liver function tests are essential in any patients receiving remdesivir, with suggested discontinuation of the drug in patients whose alt levels reach ≥ times the upper limit of normal (uln) (gilead, ) . adhering to these guidelines is of particular importance in patients with pre-existing liver disease, or in those taking other medications which can also induce transient alt and ast elevation (world health organisation, ) . the reported differences between preclinical and clinical data regarding the safety of remdesivir highlight the inadequacies of preclinical models in some contexts. for example, with regards to covid- , a concerning element of theoretical toxicity is that which affects the respiratory system. a study using mice models of middle east respiratory syndrome coronavirus (mers-cov) found remdesivir improved pulmonary pathology in infected mice and rhesus monkeys, and no respiratory toxicity was observed (gilead, ; sheahan et al., ) . in contrast, a respiratory safety study in rats showed that remdesivir had no impact on tidal volume or minute volume, but did increase respiratory rate, which returned to baseline by hours post-dose (world health organisation, ). clearly, increased respiratory rate is a manifestation of covid- , and there would be problems in assessing causality if remdesivir was also likely to cause of respiratory problems in a clinical setting. fortunately, a recent double-blind, randomized, placebo-controlled trial showed there to be no significant differences in adverse respiratory events between the remdesivir-treated and control arms (beigel et al., ) . in addition to this, preclinical safety studies performed in rats and cynomolgus monkeys suggested that the kidney was the target organ for remdesivir-induced toxicity (gilead, ) . this was a significant concern before the initial covid- clinical trials, as it is known that sars-cov- can cause acute kidney failure in severe cases (ronco, reis, & husain-syed, ) . however, this has not this article is protected by copyright. all rights reserved. been reflected in covid- clinical trials, where the presence of biomarkers indicative of renal injury have not differed in patients treated with remdesivir compared to those on placebo (beigel et al., ; gilead, ) . however, due to the inclusion of the solubility enhancer sulfobutylether βcyclodextrin sodium (sbecd) within remdesivir formulations, remdesivir is contraindicated in patients with severe renal impairment (egfr < ml/min) (european medicines agency, ). finally, remdesivir is not exempt from ddis. co-administration of remdesivir with several antibiotics including rifampicin is contraindicated, which could cause problems for any patients being treated concomitantly for tuberculosis (group, ) . this occurs because of enzyme induction which reduces systemic exposure to remdesivir. a similar interaction has also been seen with enzyme-inducing anticonvulsants, including carbamazepine, phenytoin, and phenobarbital (group, ) , where reduction in remdesivir exposure may lead to inadequate treatment of covid- . favipiravir is another broad-spectrum anti-viral prodrug which undergoes intracellular phosphoribosylation to produce its active form, favipiravir-ribofuranosyl- ′-triphosphate (favipiravir-rtp) (yousuke furuta, komeno, & nakamura, ) . it is thought that this anti-viral primarily acts by inducing lethal mutagenesis of rna viruses, although it also selectively and potently inhibits viral rdrp by acting as a pseudo purine nucleotide (dawes et al., ; sangawa et al., ) . favipiravir is currently licensed in japan for the treatment of novel and re-emerging influenza (yousuke y. furuta et al., ) . its extensive spectrum of activity against various rna virus polymerases led to favipiravir being cited as a potentially 'crucial pandemic tool', even before the outbreak of the novel coronavirus, covid- (adalja & inglesby, ) . the pk of favipiravir was initially characterised in healthy japanese volunteers (madelain et al., ) . a cmax of . µg/ml was found to occur hours post-administration, but plasma concentrations decreased rapidly due to the relatively short half-life of favipiravir (between and . hours) (madelain et al., ) . however, both cmax and half-life increase slightly after multiple doses and it has been suggested that favipiravir is capable of reaching a cmax in humans sufficient to inhibit % of sars-cov- replication, thus establishing it as an important compound in the ongoing search for covid- therapies (arshad et al., ) . marked differences in cmax have been observed between japanese and american patients with cmax values in japanese subjects being on average . µg/ml greater than those in american subjects (pmda, ) . this highlights the need for relevant covid- clinical trials to include a diverse range of subjects so that factors such as weight and ethnicity can be considered to optimise dose. the bioavailability of favipiravir is high at . % and only % of the drug is plasma protein-bound, suggesting high tissue penetration would be likely (madelain et al., ; pmda, ) . in vivo work in mice showed that the half-life of favipiravir in the lungs is double that of favipiravir in plasma, indicating slower elimination from the lungs (pmda, ) . this is thought to be of high importance in covid- , where viral load is particularly high in the lungs. for influenza treatment in adults, mg favipiravir is given twice on day of treatment, followed by mg twice daily from days to (pmda, ). however, the dosing period has been extended in ongoing covid- clinical trials: up to days in chictr and days in chictr (guan et al., ) . it is therefore essential that all pk parameters are monitored in these trials as differences, including increased cmax and decreased clearance, are expected during this prolonged dosing regimen which may impact upon safety. favipiravir has been linked to teratogenicity and embryotoxicity, and is therefore contraindicated in pregnancy (yousuke furuta et al., ) . overall, favipiravir is generally thought to have a good safety profile (asrani, devarbhavi, eaton, & kamath, ; group, ; nhs, ) . this is likely to be due to the fact that unlike other antiviral drugs such as ribavirin, favipiravir does not appear to disrupt non-viral rna or dna synthesis. however, very little is known about the long-term safety of favipiravir, as in previous clinical trials patient follow-up has been as little as days . this is perhaps less of a concern in covid- as treatment is time-limited. drug-drug interactions have been reported with favipiravir. for example, coadministration with favipiravir can increase exposure to paracetamol by around %, which may be a concern for patients with pre-existing liver disease as paracetamol is the leading cause of acute drug-induced liver injury (dili) in the uk and usa (asrani et al., ; group, ) . favipiravir can also increase patient exposure to many contraceptives, including progesterone-only pills, combined pills, and several contraceptive implants, which may cause discomfort, prolonged vaginal bleeding, and nausea (group, ; nhs, ) . whether the increased exposure to oestrogens caused by concomitant treatment with favipiravir can enhance the risk of thrombosis is not known but should be monitored, given the overwhelming evidence that covid- increases the risk of blood clots (atallah, mallah, & almahmeed, ; di micco et al., ; spiezia et al.) . interestingly , large clots are most common in patients under the age of ; almost % of women aged between - in the usa currently use either oral or long-acting contraceptives, and thus represent a particular risk group (hurley, ; prevention, ). sars-cov- virus is capable of eliciting an immune reaction in the infected individual. laboratory examinations have revealed that inflammatory factors such as interleukin (il)- , il- , il- and tumour necrosis factor-α (tnfα) are upregulated during infection and can instigate an inflammatory response in the lower airways leading to lung injury in some instances guo et al., ) . additionally, in patients with severe symptoms of covid- , there may be activation of a cytokine storm, which can cause significant tissue damage (mehta, mcauley, et al., ; shi et al., ) . a smaller proportion of patients can progress to a hyper-inflammatory state which in covid- has been suggested to resemble secondary haemophagocytic lymphohistiocytosis (shlh), a rare syndrome characterised by uncontrollable fever, cytopenia, raised ferritin levels and acute respiratory distress (seguin, galicier, boutboul, lemiale, & azoulay, ) . interleukin and tnf-α levels show the greatest increase in those who require admission to the intensive care unit (icu), suggesting that the cytokine storm is instrumental in severe covid- cases (huang et al., ) . therefore, there has been a logical progression towards the use of immunosuppressive agents as potential therapies to alleviate inflammation and hyperinflammation associated with covid- (mehta, mcauley, et al., ) . dexamethasone is a glucocorticoid that can be administered both orally and intravenously. it acts as a glucocorticoid receptor agonist and is over times more potent than endogenous cortisol, thus resulting in dose-dependent suppression of pro-inflammatory genes through a number of pathways in common with other steroids (papich, ; whelan & apfel, ; yasir & sonthalia, ) . low doses of glucocorticoids have an anti-inflammatory effect while higher doses are immunosuppressive (buttgereit et al., ) . dexamethasone can be used for inflammatory diseases such as rheumatoid arthritis (crohn's & colitis foundation, ; freeman, ) , but is recommended for short-term treatment (spanning from one to days) because of the major adverse effects which can occur with long-term treatment. one of the commonest uses of dexamethasone is for reducing cerebral oedema. as of th july , dexamethasone was undergoing evaluation in clinical trials. on th june, the results of the dexamethasone arm of the recovery trial were announced. the trial results, which are available in preprint form, showed that patients had received either oral or intravenous lowdose ( mg) dexamethasone daily for ten days (peter horby et al., ) . when compared to control patients receiving usual care only, it was shown that dexamethasone reduced deaths by one third in sars-cov- positive patients requiring ventilation, and by one fifth in patients receiving this article is protected by copyright. all rights reserved. oxygen. no benefit was observed for patients with milder covid- symptoms who did not require respiratory support (peter horby et al., ) . recent work has found that tissue inflammation and organ dysfunction seen in fatal cases of covid- are not consistent with sars-cov- distribution in tissues and cells (dorward et al., ) . tissuespecific tolerance to the virus may therefore important, and suggests that fatalities arising from covid- may be mainly due to host-mediated immune response rather than pathogen-mediated end-organ inflammation. this is consistent with the dexamethasone result in the recovery trial. dexamethasone has a bioavailability of - % and is % protein bound in plasma (spoorenberg et al., ) . it is -hydroxylated by hepatic cyp a to α-and β-hydroxy-dexamethasone, and can also be reversibly metabolised to -dehydroxymethasone and back to dexamethasone by renal corticosteroid -beta-hydrogenase isozyme (diederich et al., ; diederich, hanke, oelkers, & bähr, ; tomlinson, maggs, park, & back, ) . unlike many glucocorticoids which are predominantly excreted in urine, only about % of dexamethasone is excreted in urine (dexcel pharma technologies ltd.). glucocorticoids are generally safe drugs when given at low doses and for short periods of time (< weeks), with the risk of adverse events increasing with dose and therapy duration (yasir & sonthalia, ). short-term use of dexamethasone can result in increased appetite, mood changes, and insomnia, but most of the adverse reactions are self-limiting (nhs, ). dexamethasone can lead to b and t cell depletion, and hence lymphopenia (marinella, ) , which interestingly is also found in up to % of patients with covid- (liu, blet, smyth, & li, ) . however, despite this, the recovery trial was able to show a mortality benefit in the most severely affected covid- patients. a critical issue may be the dose that is administered -in recovery, mg/day was administered over days, which is a relatively low dose. a recent systematic review and meta-analysis of corticosteroid treatment in patients with coronavirus infection suggested that corticosteroids were associated with higher rates of bacterial infections, longer time spent in hospital and higher rates of mortality (z. yang et al., ) . however, most of the studies analysed in this meta-analysis were retrospective observational studies, generally of poor quality and did not analyse the effects according to steroid dose. other studies which have used low-to-moderate-dose corticosteroids as treatment for diseases such as viral and bacterial pneumonia reflect the results of the recovery trial, with low dose corticosteroids resulting in decreased mortality and morbidity in patients with severe pneumonia (h. li et al., ; stern et al., ) . in these studies, low-to-moderate dose corticosteroids ( - mg prednisolone, which equates to - . mg dexamethasone) were given to patients for between and days (stern et al., ) (national institute for health and care excellence, b). in keeping with the known adverse effects of corticosteroids, the systematic review showed that hyperglycaemia was significantly more frequent in the corticosteroid-treated group (stern et al., ) . dexamethasone can be involved in both pharmacokinetic and pharmacodynamic interactions. combining it with other immunosuppressants may increase the risk of serious infection (national institute for health and care excellence, c). co-treatment with ibuprofen or other nsaids increases the risk of gastrointestinal bleeding (national institute for health and care excellence, c), while its gluconeogenic effects can lead to hyperglycaemia, which in diabetic patients can lead to increased insulin doses being required (consilient health ltd., ). dexamethasone is a cyp a inducer, and may therefore interact with remdesivir, a cyp a substrate, potentially reducing its plasma exposure. although clinicians should be aware of this interaction, the risk is small given that both drugs are indicated for days or less. both tocilizumab and sarilumab are humanised anti-il- receptor monoclonal antibodies used for the treatment of moderate -severe rheumatoid arthritis, whereas siltuximab is a chimeric, human-mouse anti-il- receptor monoclonal antibody used for treatment of multicentric castleman's disease (mcd) (deisseroth et al., ; national institute for health and care excellence, e). due to their long half-life, il- inhibitors do not need to be taken daily; however, given that they are currently indicated for chronic diseases, patients receive il- inhibitor treatments for life or until treatment failure (janssen biotech inc; roche pharma; sanofi-aventis). clinical trials to assess the efficacy and safety of tocilizumab, sarilumab and siltuximab for the treatment of the inflammatory phase of covid- are ongoing. whilst the exact dosing regimens vary between trials, covid- patients will be receiving a single or short course intravenous infusion or subcutaneous injection of the il- inhibitor (clinical trial identifiers nct , nct , nct , nct , nct ). due to their similarity, it is not surprising that tocilizumab, sarilumab and siltuximab have comparable safety profiles. thus far, evidence from clinical trials in patients with rheumatoid arthritis and mcd or post-marketing have revealed that il- inhibitors are generally well-tolerated. participants were enrolled on these trials for a minimum of months and in some cases up to months. individuals with diabetes, a history of recurrent infection, age ≥ and corticosteroid use have been shown to be at an increased risk of developing a more serious infection following il- inhibitor use (jones et al., this article is protected by copyright. all rights reserved. ). whilst adverse reactions were typically seen following chronic il- inhibitor treatment, the potential for covid- patients to develop an adverse drug reaction (adr) following a single or small number of doses should not be ignored. the most common infections reported in patients receiving anti-il therapy include skin infections, respiratory infections, urinary tract infections and in some cases, opportunistic infections ranging from tuberculosis to herpes (emery et al., ; smolen et al., ) . liver injury has also been reported with a liver biopsy from a female patient who had taken tocilizumab for a month revealing focal this article is protected by copyright. all rights reserved. necrosis of hepatocytes with steatosis and early fibrosis (mahamid et al., ) . covid- also has effects on the liver, and again causality assessment may be difficult (guan et al., ) . the prescribing instructions for tocilizumab and sarilumab indicate that liver function tests are required every - weeks following treatment commencement and then every months thereafter (roche pharma; sanofi-aventis). if liver enzymes are - x uln, the dose of tocilizumab and sarilumab can be reduced until alt or ast have normalised and then treatment resumed at the therapeutic dose. where laboratory findings are > - x uln, treatment with il- inhibitors must be paused and then recommendations for - x uln followed. if elevations persist or are > x uln, tocilizumab and sarilumab treatment must be discontinued immediately (roche pharma; sanofi-aventis). whilst sarilumab and siltuximab are associated with abnormalities in liver function tests, they are typically short-lived and asymptomatic (livertox, (livertox, , b . pre-existing liver disease can worsen symptoms of dili, and in some cases increase susceptibility (david & hamilton, ) . tocilizumab, sarilumab and siltuximab are expected to undergo metabolism via catabolic pathways and not cyp processes (mccarty & robinson, ) . therefore, due to the lack of hepatic metabolism, it is assumed that the pk of the il- inhibitors will not be altered in patients with preexisting liver disease (abou-auda & sakr, ). however, tocilizumab, sarilumab and siltuximab have been shown to restore and improve cyp levels (janssen biotech inc, ; roche pharma, ; sanofi-aventis, ). this is of particular importance as cyp levels may remain elevated following treatment discontinuation due to the long half-life of the compounds. therefore, this may be a consideration for further evaluation for any dosing adjustment requirements if patients are taking medication that are metabolised by cyp enzymes. anakinra is a kd, recombinant human il- receptor antagonist that blocks the activity of proinflammatory cytokines il- α and il- β (cawthorne et al., ; dinarello, simon, & van der meer, ) . anakinra is primarily used in combination with methotrexate for reducing the symptoms and slowing the progression of joint damage in rheumatoid arthritis (national institute for health and care excellence, a). it is also used for rare inflammatory conditions such as cryopyrin-associated periodic syndromes and still's disease (national institute for health and care excellence, a). it is administered via subcutaneous injection and is supplied as a single-use, pre-filled syringe containing mg/ . ml (swedish orphan biovitrum ltd, ) . rheumatoid arthritis patients and those with still's disease and a body weight > kg must be administered mg anakinra, while patients with still's disease with a body weight < kg should have weight-based dosing starting at - mg/kg this article is protected by copyright. all rights reserved. (swedish orphan biovitrum ltd, ). the recommended starting dose for patients with cryopyrinassociated periodic syndromes is - mg/kg. if tolerated, the dose can be increased to - mg/kg to a maximum of mg/kg (swedish orphan biovitrum ltd, ) . anakinra has a short terminal half-life of approximately - hours and so must be administered daily, preferably at the same time each day (amgen inc., ) . anakinra is currently not licensed for intravenous administration or treatment of shlh but its use is endorsed by clinicians, where intravenous infusion, as opposed to subcutaneous injection, can achieve quicker and greater maximal plasma concentrations (carter, tattersall, & ramanan, ; la rosée et al., ; mehta, cron, hartwell, manson, & tattersall, ) . thus far, clinical trials have been registered to assess the use of anakinra in patients with severe covid- . additionally, two recent studies have reported positive outcomes with anakinra in covid- induced acute respiratory distress syndrome (cavalli et al., ; clinical trials.gov, c; huet et al., ) . participants were dosed mg twice daily subcutaneously for hours followed by mg daily for days in addition to standard of care (huet et al., ) . this retrospective study found that anakinra reduced rates of mortality and the need for mechanical ventilation in icu patients (huet et al., ) . anakinra was administered either subcutaneously or intravenously in the covid- biobank study (huet et al., ) . participants received subcutaneous injections at a dose of mg twice daily or via slow intravenous infusion at mg/kg per day until there was a % reduction in serum c-reactive protein levels and sustained respiratory improvements (cavalli et al., ) . whilst no safety concerns emerged with anakinra administered subcutaneously, it was discontinued due to a lack of clinical improvement and limited reduction in c-reactive protein (cavalli et al., ) . by contrast, intravenous anakinra was well-tolerated and improved clinical outcomes. notably, % of patients had improved respiratory function in comparison to % within the standard treatment group (cavalli et al., ) . in both studies, cases of alt ≥ x uln were observed in both the anakinra and the standard treatment arms. four cases of bacteraemia following intravenous anakinra were reported in the covid- biobank study, but there were no cases of bacterial infection in the ana-covid study (cavalli et al., ; huet et al., ) . whilst both studies are encouraging, they should be considered proof-of-concept trials and larger randomised trials are still needed (cavalli et al., ; huet et al., ) . subcutaneous administration of anakinra is associated with injection site reactions (kaiser et al., ) . in a review of five rheumatoid arthritis clinical trials, % of participants receiving anakinra therapy reported injection site reactions in comparison to % of participants on placebo (mertens & singh, ) . injection site reactions can range from immediate to delayed. in immediate cases, the reaction manifests as a burning sensation whereas delayed reactions present as a rash, pruritus or swelling (kaiser et al., ) . anakinra has also been reported to lead to infection, neutropenia, this article is protected by copyright. all rights reserved. thrombocytopenia, headache, and blood cholesterol increase when administered subcutaneously (swedish orphan biovitrum ltd, ) . injection site reactions that arise immediately can be eased by placing an ice pack on the injection site before and after anakinra administration and delayed reactions can be treated with topical corticosteroids or anti-histamines (kaiser et al., ) . increases in serious infection rate are common following anakinra use and frequently include upper respiratory infections, sinusitis, urinary tract infection and bronchitis (bresnihan et al., ; cohen et al., ; r. m. fleischmann et al., ) . whilst rare, cases of opportunistic infection have been reported in anakinra monotherapy or in those receiving anakinra in combination with immunosuppressive agents (salvana & salata, ; swedish orphan biovitrum ltd, ) . neutrophil counts must be monitored during the first six months of anakinra treatment and quarterly henceforth (swedish orphan biovitrum ltd, ) . in patients where the anc is < . x /l, treatment must be discontinued immediately (swedish orphan biovitrum ltd, ) . the higher doses being used in covid- trials and the potential for a greater cmax due to intravenous administration potentially raise additional safety concerns. however, earlier detection of aes should be possible since the duration of treatment will be shorter than that used in rheumatoid arthritis, coupled with the fact that patients will already be hospitalised. anakinra is catabolised and eliminated via glomerular filtration (swedish orphan biovitrum ltd, ; b.-b. yang, baughman, & sullivan, ) . caution should be exercised and dose-adjustments may be required in moderate to severe renal impairment (swedish orphan biovitrum ltd, ; b.-b. yang et al., ) . during general infections and inflammatory diseases, cyp enzymes are primarily downregulated (mallick, taneja, moorthy, & ghose, ) . similar to il- inhibitors, it may be possible that anakinra treatment restores cyp levels in infected patients (swedish orphan biovitrum ltd, ) . therefore, caution should be exerted in covid- patients receiving concomitant medications with a narrow therapeutic window drug. mild interactions can occur between anakinra and warfarin, clopidogrel, clozapine and phenytoin (group, ) . baricitinib is an oral disease-modifying anti-rheumatic drug (dmard), traditionally used in the treatment of moderate to severe active rheumatoid arthritis (al-salama & scott, ). by acting as an atp-competitive kinase inhibitor, baricitinib can selectively and potently inhibit janus kinases (jaks) - and - in a reversible manner. jaks are essential in the transduction of intracellular signals for various cytokines involved in the inflammatory and immune responses, and so by inhibiting these kinases, baricitinib is able to relieve symptoms of rheumatoid arthritis for many patients (fridman et al., ) . as described previously, a common characteristic of covid- , much like another beta-coronavirus disease sars, is a profuse inflammatory response (huang et al., ; stebbing et al., ) . increased levels of pro-inflammatory cytokines, such as interferon (ifn) -γ and il- β, have been observed in confirmed covid- cases (huang et al., ; mehta, mcauley, et al., ; russell et al., ) . furthermore, the levels of some specific cytokines appear to be related to disease severity; patients requiring admission to intensive care units show increased levels of tnfα and monocyte chemoattractant protein (mcp ). the rationale behind repurposing baricitinib as a treatment for covid- is centred on this potential for severely ill patients to present with a cytokine storm (mehta, mcauley, et al., ; russell et al., ) . by dampening the inflammatory response, it is postulated that baricitinib will be able to relieve covid- symptoms. data modelled using artificial intelligence techniques suggests baricitinib may work by inhibiting virus entry into cells via an endocytic regulator known to be involved in coronavirus internalisation, ap -associated protein kinase (aak ) (burkard et al., ; richardson et al., ) . baricitinib, as well as being capable of jak and jak inhibition, is a high-affinity inhibitor of aak . patients tend to tolerate baricitinib well, and it has a relatively good safety profile (keystone et al., ) . however, as with tocilizumab and sarilumab treatment, a very common (≥ / ) ae observed in patients taking baricitinib, but not in the placebo arm, is upper respiratory tract infection, which may be related to its ability to suppress the immune system (eli lilly, ) . patients taking baricitinib have the potential to develop respiratory tract infections which may make it difficult to distinguish whether any deterioration is due to covid- or a secondary infection. other opportunistic infections including herpes zoster and urinary tract infections were also more common in the treated arm compared to placebo, and dose reduction is recommended for patients with a history of chronic infections (eli lilly, ; josef s. smolen et al., ) . secondary infections are not uncommon in severe covid- patients and so the use of a drug that may make patients increasingly prone to infections will depend on the harm-benefit ratio for severe cases of covid- (world health organisation, a). baricitinib is currently still being trialled in patients with covid- with a therapeutic dose of - mg once daily which is the same as the recommended dosage for the treatment of rheumatoid arthritis (cantini et al., ; richardson et al., ) . there have been a small number of reports from patients taking this recommended dosage for the treatment of rheumatoid arthritis presenting with deep vein thrombosis (dvt), which was severe in some of these cases (taylor et al., ) . this is a cause for this article is protected by copyright. all rights reserved. concern as there are increasing reports of covid- patients, especially those who are critically ill and in the icu, with thrombotic complications including pulmonary embolism and other venous and arterial thrombotic events (klok et al., ; middeldorp et al.) . as baricitinib has been reported to cause dvt, there is the potential for disease-drug interactions with covid- patients taking baricitinib potentially more likely to develop thrombotic complications. in order to mitigate this risk, alternative jak inhibitors, which have a lower risk of thrombotic events, such as ruxolitinib, may be considered in the context of covid- (alvarez-larran et al., ) . however, unlike baricitinib, ruxolitinib is primarily metabolised by cyp a (l. p. h. yang & keating, ) . this means that prescribing ruxolitinib instead of baricitinib may increase the risk of cyp a -related ddis (ogu & maxa, ) . baricitinib is not predicted to be involved in any problematic ddis. coadministration with both cyp a inhibitors (fluconazole) and inducers (rifampicin) failed to result in any clinically relevant changes to baricitinib exposure (eli lilly, ). emerging reports have revealed that patients with covid- experience renal impairment, which could be attributed ace receptor expression on kidney endothelial cells (varga et al., ) . baricitinib should not be given to patients with renal impairment as the majority of the drug is cleared through the kidneys, and monitoring of renal function will be important to prevent aes related to over-exposure to baricitinib in those with deteriorating renal function (eli lilly, ) . type ifns are a group of cytokines produced during viral infection. notably, ifn-β- a has a leading role in activating genes involved in immunomodulation, suppressing the inflammatory response and anti-viral effects (sallard, lescure, yazdanpanah, mentre, & peiffer-smadja, ) . whilst a variety of type ifns exist, in vitro evidence has shown that ifn-β- a and ifn-β- b are the most potent in the inhibition of sars-cov and mers-cov (chan et al., ; hensley et al., ) . within the lungs, ifnβ- has been shown to upregulate levels of the enzyme cluster of differentiation (cd ), which inhibits vascular leakage, increases the secretion of anti-inflammatory adenosine and preserves pulmonary endothelial barrier function (kiss et al., ; sallard et al., ) . however, in vivo research has revealed that timing of administration of ifn-β- is imperative for positive effects. when administered shortly after mers-cov infection, ifn-β- protected mice from lethal infection, whereas delayed administration failed to effectively inhibit viral replication or pro-inflammatory cytokines, leading to fatal pneumonia (channappanavar et al., ) . interestingly, in vitro evidence has revealed this article is protected by copyright. all rights reserved. that sars-cov- is more sensitive to ifn-β- treatment than mers-cov and sars-cov, and thus supports the tenet that treatment with ifn-β- may be beneficial for covid- patients (lokugamage, schindewolf, & menachery, ; sheahan et al., ; thiel & weber, ) . it is assumed that treatment of covid- patients with ifn-β- will strengthen the host immune response and prevent the worsening of severe respiratory tract manifestations. ifn-β- therapy has been used for the long-term management of multiple sclerosis (ms) and has been associated with a number of aes. when administered subcutaneously in ms patients, the most common aes were flu-like symptoms, injection site reactions, worsening of ms symptoms, menstrual disorders, mood alterations and laboratory abnormalities (walther & hohlfeld, ) . the most common laboratory abnormalities were neutropenia, leukopenia, lymphopenia and raised aminotransferases (walther & hohlfeld, ) . a genome-wide association study of patients with ifnβ induced liver injury showed that rs which has been linked to differential expression of interferon regulatory factor (irf)- is a predisposing factor (kowalec et al., ) . this may be related to the fact that irf leads to apoptosis in the presence of ifn-β. depression is a common ae reported in patients receiving subcutaneous ifn-β- therapy, and thus caution is needed when administering to those with a previous or current history of depressive disorder (biogen) . whilst rare, careful monitoring of clinical manifestations such as new onset hypertension, thrombocytopenia, impaired renal function and fever are required in order to identify cases of thrombotic microangiopathy (tma) (biogen) . tma is rare and has been reported at different time points of ifn-β- therapy (biogen; nishio et al., ; yam, fok, mclean, butler, & kempster, ) . laboratory findings of a decreased platelet count, increased serum lactate dehydrogenase (ldh) and red blood cell fragmentation are suggestive of tma (biogen) . if diagnosed, patients must discontinue ifn-β- therapy and will require plasma exchange (biogen) . sng is an inhaled form of ifn-β- a produced by synairgen. the company have tested the efficacy and safety of the drug for the prevention and treatment of symptoms associated with respiratory viral infection in asthma and chronic obstructive pulmonary disease (copd) (synairgen plc, ). a randomised, placebo-controlled phase trial is currently ongoing to assess the safety and efficacy of inhaled sng for the treatment of patients with covid- (nct ). data from the asthma trials have revealed that when administered via inhalation, high levels of ifn-β- a are achieved within the lungs with lower levels within the circulation leading to improvements in lung function, antiviral responses and better asthma control (djukanović et al., ) . inhaled sng seems to have a good safety profile; patients within the sng arm reported cardiac palpitations whereas no cases were reported in the placebo arm, but symptoms were mild and not considered clinically significant (djukanović et al., ) . this article is protected by copyright. all rights reserved. a clinical trial has been undertaken in hospitalised covid- patients where the triple combination of ifn-β, lopinavir-ritonavir and ribavirin was compared to lopinavir-ritonavir and ribavirin (hung et al., ; shalhoub, ) . patients in the triple combination therapy arm achieved negative tests results faster than those in the control arm, with improved patient symptoms, decreased viral shedding and decreased overall length of stay in the hospital compared to those in the control group (hung et al., ) . aes reported in both groups included nausea and diarrhoea. however, due to polypharmacy in this trial, it was difficult to determine the effect of ifn-β on sars-cov- alone. ifn-β has reported ddis with other covid- therapies including chloroquine and hyrdroxychloroquine, and with anakinra, sarilumab and tocilizumab (group, ) . ddis have also been reported with metamizole (analgesic), linezolid (antibacterial), clozapine (antipsychotic), zidovudine (hiv antiretroviral therapy) and some immunosuppressants (adalimumab, azathioprine and pirfenidone) (group, ) . reviewing the safety of potential covid- treatments (table ) is complex due to the fast-moving pace of research in this field. for example, chloroquine and hydroxychloroquine with or without an accompanying macrolide antibiotic, have consistently been at the forefront of covid- research efforts since the outbreak began. however, the astonishing developments over a week or so have led to retraction of a highly publicised paper, and results from a post-exposure prophylaxis trial and a treatment trial (recovery), both of which have shown no beneficial effect of hydroxychloroquine (boulware et al., ; mehra, ruschitzka, & patel, ) . this highlights that the rapid rate of discoveries surrounding covid- therapies generates the need to update this perspective frequently, in order to ensure that the safety of any newly repositioned therapies, novel developmental compounds, or new therapeutic combinations are investigated. for example, the potential use of heparin in novel forms, including nebulised therapy (clinical trial identifier nct ), as an antiviral agent is currently the subject of several investigational trials. in addition, the potential utility of nitazoxanide is currently the subject of several clinical trials (clinical trials.gov, a; pepperrell, pilkington, owen, wang, & hill, ; rajoli et al., ) . it is clearly essential that the harm:benefit ratio of any pharmaceuticals being considered for use in the treatment of covid- are thoroughly considered. this ratio changes dependent upon the disease stage and is correlated to potential mortality. for example, a higher risk may be accepted for patients in the later stage of severe disease than the same therapeutic agent administered in mild disease. this difference in harm-benefit analysis becomes even more striking when considering the use of such agents to prevent infection. as is the case for many highly contagious viruses, prevention by prophylaxis would be incredibly valuable. some of the agents described in this review, including chloroquine and ritonavir have been suggested as potential prophylactic agents, but to date, data on efficacy have been disappointing (rathi, ish, kalantri, & kalantri, ; spinelli, ceccarelli, di franco, & conti, ) . clearly, treatment duration for prophylaxis is expected to be longer than for treatment of covid- , and this may further alter the harm-benefit ratio, reinforcing the need for safety considerations at the outset of any clinical trials. similarly, the evaluation of therapy risk also applies to long-term recovery. as the current pandemic progresses, it is becoming apparent that being discharged from hospital does not necessarily mean that patients are free from covid- symptoms. large numbers of patients who have survived severe sars-cov- infection may have incurred long-term health problems, including some permanent loss of lung and kidney function (foundation, ; su et al., ; summers, ) . consequently, it is probable that long-term therapies will be required for many patients to maintain, or ideally restore, normal physiological organ function. it is vital that therapies which will be used to treat patients during their long-term recovery are also undergoing evaluation for their safety, particularly as many of these agents may need to be administered over much longer periods of time than initial covid- treatments. the identification and characterisation of biomarkers of disease and safety will be invaluable in the further development and deployment of therapies for covid- . disease biomarkers, for example of lung injury or the hyperinflammatory reponse, may allow the stratification of therapy in order to select the agent best suited to the stage of disease. moreover, biomarkers should be considered to monitor patient safety in cases of known aes. for example, the manufacturer's guidelines for remdesivir recommend daily liver function tests due to the risk of transaminase elevations (gilead, ) . these tests are essential, particularly with regards to covid- where increased alt levels are reported to be common amongst hospitalised patients (bangash et al., ; l. zhang et al., ). looking to the future, improvements in the specificity, predictivity and reliability of drug-induced organ damage, through academic-industry partnerships such as the biomarker qualification program in the critical path institute in the us, and the european innovative medicines initiative consortium transbioline, will help improve clinical assessment of covid- drug safety issues. continued enhancements in the speed, predictivity, and human translation of safety assessment for toxicity of anti-viral compounds is clearly warranted, and this may include animal models of sars-cov- as well as in vitro models, in order to assess efficacy alongside safety. such a full understanding for individual therapies will indicate the combinations that can have the potential to provide the best this article is protected by copyright. all rights reserved. synergy for benefit, while forewarning of the potential for increased risk/harm through pharmacokinetic or toxicodynamic interaction. although outside the scope of this review, a vaccine for covid- remains the greatest hope to end the pandemic and protect the population. as of th july , according to who there are vaccines in clinical trial stages and in preclinical stages of evaluation (world health organisation, b). currently, potential vaccines are only just beginning to be tested for efficacy in humans in early phase studies, and therefore safety data will begin to emerge as larger numbers of individuals are administered the vaccine. safety data regarding preliminary vaccinations against sars and mers are limited, but the available information may be useful during the development of covid- vaccines due to the similarities between the coronavirus strains (padron-regalado, ). one safety concern relevant to coronaviruses is the potential for the induction of antibody-dependent enhancement (ade), a phenomenon which was observed in cats vaccinated against feline infectious peritonitis coronavirus, and has also been seen in patients vaccinated against zika virus and dengue virus (khandia et al., ; padron-regalado, ; vennema et al., ) . ade can occur when nonneutralising antibodies bind to virus particles and increase their uptake into host cells, instead of rendering them non-infectious (padron-regalado, ; tirado & yoon, ) . this caused concern in initial sars vaccine development, but can reportedly be avoided by using truncated versions of the viral s glycoproteins (he et al., ) . acknowledging safety concerns such as this, as well as the ways they can be attenuated, may be paramount in the timely development of a vaccine against covid- . in conclusion, although expanding extremely rapidly, the field of therapies to treat covid- remains in its infancy. safety will continue to play a major role in therapeutic success, as apparent with recent reports of increased cardiac toxicity associated with the use of chloroquine/hydroxychloroquine in the treatment of covid- , despite its long history of use as an antimalarial. above all, this perspective has exemplified the need to view safety concerns in the context of the individual and specific phase of disease in order to formulate a comprehensive harm-benefit balance. importantly, an awareness of potential safety concerns will support the development of the next stage of therapy targeting prophylaxis and recovery post-covid infection. it is imperative that safety scientists look to rise to the challenge of covid- by utilising their expertise in mechanistic understanding, biomarker development and toxicokinetic modelling in order to support the development of covid- therapies that can be used effectively and safely. aa, bkp, cbb, ceg, rlj, rtk, shk, slp and xm declare that that they have no conflicts of interest. ao declares no direct conflict of interest but is director and cso for tandem nano ltd and a co-inventor of patents relating to drug delivery of infectious disease medicines. aec reports no direct conflict of interest but receives research funding for the support of sp and rlj from servier pharmaceuticals and astrazeneca, these are unrelated to the published work. aec receives additional unrelated research funding from janssen pharmaceuticals. ao has received consultancy and /or research funding from viiv healthcare, merck, astrazeneca, gilead, and janssen unrelated to the current paper. db received educational grants and/or consultancy from abbvie, novartis, merck, gilead and viiv healthcare outside the submitted work. mp receives research funding from various organisations including the mrc, nihr, eu commission and health education england. he has also received partnership funding for the following: mrc clinical pharmacology training scheme (co-funded by mrc and roche, ucb, eli lilly and novartis); and a phd studentship jointly funded by epsrc and astra zeneca. he has also unrestricted educational grant support for the uk pharmacogenetics and stratified medicine network from bristol-myers squibb and ucb. none of the funding received is related to the current paper. figure : overview of the mechanisms of action of the repurposed drugs undergoing clinical trials for the treatment of covid- that will be reviewed in this perspective. compounds in red represent those that are viral entry inhibitors, compounds in green represent disruptors of cellular viral processing, compounds in blue are modulators of the hyperinflammatory phase of infection and compounds in yellow stimulate host immunomodulatory and anti-viral activity. abbreviations: ace , angiotensin converting enzyme ; il- , interleukin- ; il- , interleukin- ; jak, janus kinase; rdrp, rna-dependent rna polymerases; 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barriers to achieving health and high-quality health care. disparities may be observed by "any characteristic historically linked to discrimination or exclusion," including but not limited to race/ethnicity, socioeconomic status, religion, sexual orientation, gender identity, age, geographic location, or disability. in this first issue, authors describe the myriad of ways in which disparities adversely affect individuals with chronic rheumatic diseases. two frameworks: critical race theory and social determinants of health, are presented to guide the way disparities are studied, described, and ultimately how they may be addressed. critical race theory asserts that race is a social construct and highlights the pervasive role racism continues to play in our society and in health care. social determinants of health refer to the "features of and pathways by which societal conditions affect health and that potentially can be altered by informed action." studies demonstrating the role of socioeconomic status both at the individual and at the area levels are clear applications of the way in which social determinants directly influence health outcomes. within the health care setting, the use of quality metrics is described as another potential strategy to guide both the way in which disparities are documented and how they may be addressed. this issue also explores disease-specific disparities by factors including race/ethnicity, gender, and region in rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, and gout. authors also describe population-specific disparities in childhood-onset lupus, and among the american indian/alaska native populations. in this issue, we present the striking prevalence of health disparities in the field of rheumatology. the covid- pandemic has further revealed and deepened existing disparities by race/ethnicity and socioeconomic status that require urgent multifaceted, multilevel interventions by our rheumatology community. we offer frameworks to consider these disparities and the impetus to address them through further research, high-quality patient care, and advocacy. the secretary's advisory committee on national health promotion and disease prevention objectives for critical race theory, race equity, and public health: toward antiracism praxis a glossary for social epidemiology key: cord- -ykqnbsqe authors: amore bonapasta, stefano; santoni, simone; cisano, claudio title: emergency laparoscopic surgery during covid- : what can we do and how to do it safely date: - - journal: j trauma acute care surg doi: . /ta. sha: doc_id: cord_uid: ykqnbsqe nan conversely, other authors consider that laparoscopy remains the preferred surgical approach. such an assumption is based on the lack of data to support that covid- is transmitted by surgical smoke or pneumoperitoneum, the well-known health benefits for patients and the opportunity for containment and filtration of the surgical gas with smoke evacuation systems, which are widely recommended. so, although we disagree with the gross but reasonable change of policy, according to which copyright © wolters kluwer health, inc. all rights reserved. appendectomy. the appendix-mesoappendix complex can be freed from its adjacent, often inflamed, tissue with blunt dissection. then the appendix can be removed through either an antegrade (the mesoappendix is ligated first) or a retrograde technique (the appendiceal base is exposed, dissected and transected first). many different techniques can be used for both mesoappendix dissection and appendicular stump closure, without using energy devices. they can be stapled or safely managed with simple ligation, endoscopic clip, endoloop or hem-o-lok. copyright © wolters kluwer health, inc. all rights reserved. in our opinion, in order to avoid the electrosurgical use, the retrograde approach could be easier, especially when the appendix is very inflamed or it's surrounded by inflammatory tissue. our preference is to close the appendicular stump performing a simple intracorporeal ligation, tying off the base. another cost-effective and safe option is to use hem-o-lok. once the appendix is divided, mesoappendix can be ligated with ties, endoloop or endoscopic clips. in stable patients, perforated peptic ulcers smaller than cm can be treated with a laparoscopic primary suture, which does not require any energy. laparoscopy allows for complete abdominal exploration and peritoneal lavage, if needed. single adhesion causing small bowel obstruction. in case of small bowel obstruction, the laparoscopic approach can be beneficial for selected copyright © wolters kluwer health, inc. all rights reserved. cases, without very distended loops of bowel and multiple complex adhesions. one cause of small bowel obstruction is a single fibrous band which produces an overhanging or a rotation of an intestinal loop. in such a case, the fibrous band is usually coagulated and cut. we simply suggest to place endoscopic clips and cut between the clips. we congratulate dr di saverio and coauthors on their study, although we wish to emphasize that we should not stop to perform emergency laparoscopy tout-court, because it allows optimizing patient care and outcomes. on the other hand, when clinically appropriate, we have to determine if it is safely feasible. unfortunately, in the current climate, patients are reticent to access to hospital care even for emergency conditions, because of fear of exposure to covid ( ). delayed access can lead to more complex local inflammation, for which electric devices (as bipolar energy) are often required, or to conditions of abdominal distension or hemodynamic instability that contraindicates minimally invasive surgery. patients should be made aware of the risks of delayed access to the emergency department. copyright © wolters kluwer health, inc. all rights reserved. laparoscopy at all costs? not now during covid- and not for acute care surgery and emergency colorectal surgery: a practical algorithm from a hub tertiary teaching hospital in emergency surgery in suspected covid- patients with acute abdomen: case series and perspectives what is the appropriate use of laparoscopy over open procedures in the current covid- climate? kickboxing kick: laparoscopic management of jejunal perforation after blunt abdominal trauma-video vignette key: cord- - nc d v authors: aylward, r bruce; acharya, arnab; england, sarah; agocs, mary; linkins, jennifer title: global health goals: lessons from the worldwide effort to eradicate poliomyelitis date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: nc d v the global polio eradication initiative was launched in . assessment of the politics, production, financing, and economics of this international effort has suggested six lessons that might be pertinent to the pursuit of other global health goals. first, such goals should be based on technically sound strategies with proven operational feasibility in a large geographical area. second, before launching an initiative, an informed collective decision must be negotiated and agreed in an appropriate international forum to keep to a minimum long-term risks in financing and implementation. third, if substantial community engagement is envisaged, efficient deployment of sufficient resources at that level necessitates a defined, time-limited input by the community within a properly managed partnership. fourth, although the so-called fair-share concept is arguably the best way to finance such goals, its limitations must be recognised early and alternative strategies developed for settings where it does not work. fifth, international health goals must be designed and pursued within existing health systems if they are to secure and sustain broad support. finally, countries, regions, or populations most likely to delay the achievement of a global health goal should be identified at the outset to ensure provision of sufficient resources and attention. the greatest threats to poliomyelitis eradication are a financing gap of us$ million and difficulties in strategy implementation in at most five countries. increasing travel and globalisation of commerce has farreaching implications for health. , substantial attention has been given to the threats that globalisation poses to the management of infectious diseases, but less to its opportunities. , heightened international awareness of the burden and threat of many infectious diseases has spawned partnerships and alliances to coordinate additional resources for their control. though the most cited example of international collaboration is the global fund to fight aids, tuberculosis and malaria, it is only the most recent. perhaps the best example of such collaboration was the successful international effort to eradicate smallpox in the s and s. more recently, coordinated efforts to combat global health threats have included the global partnership to stop tb, the roll back malaria initiative, and the global alliance for vaccines and immunization (gavi). innovative strategies have also been established to tackle non-communicable diseases, most notably through the framework convention on tobacco control. common to these initiatives has been the conviction that coordinated international action is in the interest of all countries. it has even been argued that these initiatives are "global public goods for health". the effort to eradicate poliomyelitis is one such initiative, since once eradication has been achieved, everyone will be protected from the virus and one person's protection will not reduce that available to others. , in this paper, we assess the politics, production, financing, and economics of poliomyelitis eradication to identify lessons that might be relevant to the pursuit of other global health goals. the decision to pursue eradication the successful conclusion of the international smallpox eradication campaign in created substantial interest in further eradication efforts. however, enthusiasm was countered by concerns that targeted objectives could compromise efforts to develop strong primary health-care systems and by doubts about the technical feasibility of eradicating any organism after smallpox. , the most important factor in overcoming scientific concerns was the interruption of poliovirus transmission in large areas of the americas by use of a four-pronged strategy. the leadership for launching a global poliomyelitis eradication initiative was secured at a meeting in march, , at which the who director-general was convinced of the merit of such an effort. , months later, the world health assembly, consisting of the ministers of health of all member states, unanimously adopted a poliomyelitis eradication resolution. the eradication goal was subsequently reviewed and endorsed by the world summit for children-the largest ever gathering of heads of state. leaders from lowincome, middle-income, and high-income countries have continued to reaffirm their commitment to poliomyelitis eradication through resolutions adopted in forums such as the organization of african unity, the south asian association for regional cooperation, and g summits. [ ] [ ] [ ] implementation of strategies by the end of , every country had introduced the who-recommended poliomyelitis eradication strategies or a variant thereof, but the effort required to do so was correlated inversely with countries' incomes. in the few high-income countries in which poliomyelitis cases were reported in (eg, france and spain) elimination of the virus was relatively straightforward because of temperate climate, higher vaccine effectiveness in such settings, high levels of sanitation, and strong health systems. by contrast, eliminating endemic poliomyelitis from low-income countries has required massive efforts sustained for - years. implementation of national immunisation days (nids) has been a huge challenge; in china and india, for example, about million and million children, respectively, were immunised in a few days-the achievement was repeated month later, and then annually global health goals: lessons from the worldwide effort to eradicate poliomyelitis the global polio eradication initiative was launched in . assessment of the politics, production, financing, and economics of this international effort has suggested six lessons that might be pertinent to the pursuit of other global health goals. first, such goals should be based on technically sound strategies with proven operational feasibility in a large geographical area. second, before launching an initiative, an informed collective decision must be negotiated and agreed in an appropriate international forum to keep to a minimum long-term risks in financing and implementation. third, if substantial community engagement is envisaged, efficient deployment of sufficient resources at that level necessitates a defined, time-limited input by the community within a properly managed partnership. fourth, although the so-called fair-share concept is arguably the best way to finance such goals, its limitations must be recognised early and alternative strategies developed for settings where it does not work. fifth, international health goals must be designed and pursued within existing health systems if they are to secure and sustain broad support. finally, countries, regions, or populations most likely to delay the achievement of a global health goal should be identified at the outset to ensure provision of sufficient resources and attention. the greatest threats to poliomyelitis eradication are a financing gap of us$ million and difficulties in strategy implementation in at most five countries. for more than years. , because of the huge numbers of people and vehicles required to implement nids, governments of many countries have drawn heavily on the private sector, as well as on ministries of information, transport, and defence, among others, to help reach all children. people crossing borders can transmit poliomyelitis during the interval between nids being held in one country and in its neighbour. recognising this factor, many countries have synchronised their nids (figure ). in operation mecacar for example, asian, european, and middle eastern countries immunised million children in april and may, , and repeated the activity each year for years. similar coordination followed in south asia, west africa, , and then central africa, where the conflict-affected countries of the democratic republic of the congo, angola, congo, and gabon synchronised three rounds of nids in july-september, , to immunise million children. , by the year , all poliomyelitis-affected countries were reporting standardised data for acutely paralysed children and surveillance performance to who either weekly or monthly. central to this surveillance capacity has been a worldwide laboratory network for enterovirus diagnosis that now comprises facilities. even in conflict-affected areas such as afghanistan, the democratic republic of the congo, and somalia, surveillance in was nearing the international standard that will be required for poliomyelitis-free certification. coordination though poliomyelitis eradication activities have been led, coordinated, and implemented by the governments of poliomyelitis-affected countries, the support of a publicprivate partnership has been essential. this partnership, spearheaded by who, rotary international, the us centers for disease control and prevention (cdc), and unicef has facilitated the inputs of donor governments and a vast array of other organisations. the most remarkable of these partners is rotary international, a private-sector service organisation, which will have contributed nearly us$ million of its own resources by the end of in addition to mobilising much of the money contributed by governments. to coordinate this partnership, mechanisms were established at global, regional, and country levels for strategic planning, policy development and priority setting, resource mobilisation, and financing. additional mechanisms were established to manage the laboratory network and govern the process for eventually certifying the world as free from poliomyelitis. direct costs a conservative estimate of the financial and in-kind expenditures in poliomyelits-endemic countries was generated on the basis of the number of hours worked per country to implement nids, the most expensive and labour-intensive eradication strategy. without wishing to diminish the broader significance of this largely volunteer effort to the success of the initiative, for the purposes of economic evaluation it has been valued by use of labour market rates from the statistical database for the year world development indicators. on the basis of these calculations, poliomyelitis-endemic countries will have contributed at least $ · billion in wages alone between and . this figure does not include substantial government and private-sector resources to pay for petrol, social mobilisation, training, and other costs. many of these people were government employees who were temporarily released from regular duties. between and , external sources will have provided at least $ billion to poliomyelitis-endemic countries. of more than external donors to date, have already contributed more than $ million and at least $ million (table ) ; some, such as rotary international, are not traditional sources of overseas development assistance. central tracking of resource requirements and funding flows, and multilateral and bilateral funding mechanisms, have enabled efficient accommodation of the needs of donors and recipient countries. the total cost of poliomyelitis eradication during - will be more than $ billion. a cost-benefit analysis of the paho regional programme noted ". . . polio eradication appeared economically justified solely in terms of reduced treatment costs, irrespective of reduced pain, suffering and incapacitation", calculating that the net present value of discounted savings during a -year period from the start of the campaign was $ · million. a similar analysis for worldwide eradication throughout - showed that even when including only the savings in direct costs for treatment and rehabilitation, " . . . the 'break-even' point at which benefits exceeded costs was the year , with a saving of us$ million by the year ". the cost-effectiveness of global poliomyelitis eradication was reassessed for - to analyse the potential effects of poliomyelitis immunisation policies that might be adopted after worldwide certification of eradication. from an economic perspective, the best-case scenario was assumed to be cessation of routine immunisation with the oral poliomyelitis vaccine as soon as possible after interruption of wild poliovirus. the worst-case scenario was assumed to be replacement of this vaccine by universal childhood immunisation with the more expensive inactivated poliovirus vaccine to reduce the risk of vaccine-associated paralytic poliomyelitis or poliomyelitis outbreaks due to a circulating vaccine-derived poliovirus. [ ] [ ] [ ] in this analysis, even in the worst-case scenario, poliomyelitis eradication would save money in all countries, apart from low-income countries where the cost per discounted disabilityadjusted life-year (daly) saved would still be low, at about $ (table ) . the world health assembly resolution that launched the global polio eradication initiative stated that eradication should be pursued in ways that strengthened the delivery of primary health-care services in general and immunisation programmes in particular. what has been the effect of poliomyelitis eradication activities on the delivery of specific health services or the development of health systems? three irrefutable benefits have included widespread vitamin a distribution, enhanced global surveillance capacity, and improved worldwide cooperation between enterovirus laboratories. , by distributing vitamin a supplements during poliomyelitis nids, an estimated childhood deaths were averted during - alone, and the value of using immunisation contacts to deliver micronutrient supplements was widely reinforced. , the surveillance capacity developed for poliomyelitis eradication has also been used to detect and respond to outbreaks of diseases such as measles, meningitis, cholera, and yellow fever. the poliomyelitis-eradication infrastructure and capacity was also used to assist in the international effort to control severe acute respiratory syndrome (sars). however, effects on routine immunisation services have been controversial. [ ] [ ] [ ] the poliomyelitis initiative has invested heavily in physical and human resources for routine immunisation. the cold chain, communications, and transport capacity have been replaced or refurbished in many low-income countries, especially in sub-saharan africa, and tens of thousands of people have been trained or retrained worldwide in giving vaccinations. questions have been asked, however, as to whether short-term disruptions by nids in the delivery of routine immunisation and other services will have long-term consequences. evaluation of the effect on health systems has been hampered by a lack of credible baseline data, the absence of control groups, and the concurrent implementation of major health-system reforms, such as decentralisation and sector-wide approaches. , most commentators agree that there are positive synergies between poliomyelitis eradication and development of health systems, but opportunities have yet to be fully exploited. , status of eradication and risks to completion when the world health assembly voted to eradicate poliomyelitis in , more than countries (defined by year geographic borders) on five continents were known or suspected to have indigenous transmission of wild poliovirus (figure ). though only cases were reported worldwide that year it is estimated that more than children were actually paralysed. , more than % of the reported cases in were in low or lower-middle income countries and half were in the asian subcontinent-mostly in india. outside the americas, few areas were free of poliomyelitis-mainly industrialised countries and small island nations. by the end of , poliomyelitis was on the brink of eradication, with only ten countries in which it was endemic and virologically confirmed cases that year. by the end of , only seven countries-the lowest number ever-were known to have endemic poliomyelitis (figure ). the total number of cases exceeded that of , however, because of marked increases in india and nigeria ( figure ). in india, the increase was due to an epidemic that originated in the northern state of uttar pradesh and spread rapidly to adjoining and distant states, many of which had been free from poliomyelitis for some years. by contrast, the increase in nigeria was largely due to improved reporting in the north of the country. complete eradication of poliovirus transmission will require overcoming challenges at national and international levels. at the national level, it will be essential to close gaps in the quality of supplementary immunisation activities in the six states or provinces of india, nigeria, and pakistan that accounted for % of poliomyelitis cases in . northern india in particular poses challenges, since the combination of a weak health infrastructure, fragile political alliances and, to a lesser degree, suspicion of government services by minority communities, has hampered efforts to mobilise all sectors of society and reach every child. in parts of afghanistan, eastern angola, and the mogadishu area of somalia, continued improvement in access to children is needed to break the few remaining chains of virus transmission in these areas. internationally, the main challenge will be closing the $ million funding gap for activities planned for - , while maintaining political visibility of, and commitment to, the eradication of a disappearing disease. increasingly, international discussion and debate has focussed on future poliomyelitis immunisation policy. from the outset of the eradication initiative, much of the attraction of this international health goal has been the argument that its achievement would reap economic as well as humanitarian benefits. these economic benefits would accrue mainly if and when poliomyelitis immunisation could stop. that these economic benefits could accumulate in perpetuity underpinned the arguments of the champions of poliomyelitis eradication, engaged political leadership, and mobilised stakeholders, in particular those from the private sector. however, several factors have complicated the development of, and consensus on, future immunisation policy. these factors range from increasing evidence that vaccine-derived polioviruses can, albeit rarely, regain the capacity to circulate and cause outbreaks, to increasing concerns about the use of biological agents. [ ] [ ] [ ] [ ] although cessation of immunisation with the oral poliovirus vaccine remains a major objective of the eradication initiative, much work is required to establish the scientific soundness, operational feasibility, and economic rationale for the strategies that have been proposed to achieve this end. in this review of the poliomyelitis eradication initiative, we have derived six lessons that could assist the planning and pursuit of worldwide health goals, whether global public goods for health or other health efforts in which international collective action might be warranted. first, and perhaps foremost, is the need for proven tools and technically sound strategies. additionally, their operational feasibility should be demonstrated conclusively on a large geographical scale, under as many conditions as possible, before attempting to launch a worldwide effort. international consensus on poliomyelitis eradication was achieved only after it had been shown in the americas during the s that strategies could be massively scaled i n d i a n i g e r i a p a k i s t a n a f g h a n i s t a n up and implemented in regions with extremely weak health systems, or that were affected by conflict, or both. such proof is essential for obtaining and sustaining the political and financial support required for the - years needed to pursue most international health goals. the second lesson is that any international health goal should be strongly endorsed at the highest possible level, arguably the world health assembly. such endorsement will be essential for dealing with the debate and concerns that will arise as the programme is scaled up and opportunity and other costs are increasingly evident and better understood. although prominent champions had a major role in promoting global eradication of poliomyelitis, the decision to launch the initiative followed debate at the world health assembly. despite consensus at that forum, an often heated debate has flared as to whether the opportunity costs of eradication outweigh benefits. of especial concern has been whether the deployment of resources has compromised the strengthening of health systems in resource-poor countries, or limited their capacity to control other diseases. it has also been noted that some delegates to the assembly in might not have made a truly informed decision on the launching of the initiative, since there had been no clear statement on resource requirements or strategies. these debates have contributed to the programme's chronic funding gap, and to the late introduction of key strategies in some countries. the cost-effectiveness analyses summarised in this paper suggest that all countries stand to benefit from this investment irrespective of income level, but this assessment is not universally accepted. a third lesson is that efficient management is needed to achieve the necessary scale of collective action. two major factors facilitated participation in the eradication initiative: a well defined, time-limited ( - days) demand on the community, and sufficient resources to enable the community to implement activities. ensuring sufficient resources required moving beyond building an international health partnership to managing one efficiently. critical to achieving efficiency was the use of common strategic plans, clear roles and responsibilities, and national and international forums to coordinate financing, human resources, and institutional arrangements. fourth, given the amount of external financing required to achieve international health goals, strategies will usually necessitate targeting political decision-makers, by means such as professional lobbying firms and international forums to establish the commitment of heads of state. because all countries will benefit economically from poliomyelitis eradication, rotary international, as part of its advocacy strategy, calculated so-called fair shares of the total budget to be financed by each major donor country, based on their contributions to who's regular budget. however, only of the who member states that traditionally give overseas development assistance had contributed to the eradication initiative by mid- . of these, seven contributed the equivalent or more than their estimated fair share and nine substantially less. the six countries that did not contribute are free riders in economic terms, since they will share in the benefits. while the fairshare concept is of great value for setting resource mobilisation targets and negotiating appropriate contributions with interested donors, it has substantial limitations. most importantly, it will not mobilise funds from donors who did not fully endorse the goal in the first place. pursuing the fair-share argument can also unveil basic, irreconcilable disagreements on their calculation. such limitations must be recognised early and alternate strategies developed for settings where this argument alone is not sufficient. fifth, worldwide health goals should be designed so that they can be pursued within existing health systems and, ideally, contribute to the strengthening of these systems. although proponents have stated that poliomyelitis eradication strengthens other health services, they and their detractors have used anecdotal information to argue their cases because of a lack of objective criteria and indicators. of note, some of the largest donors to poliomyelitis eradication are those who are institutionally committed to the strengthening of health systems, but who joined the initiative after reconciliation of concerns about the effect on the delivery of other services. however, proponents of future worldwide health goals should recognise the challenge of measuring such indirect benefits, be modest in arguing their worth, and ensure there are agreed indicators and the capacity and mechanisms for their monitoring. the final lesson is the need to identify countries, regions, or populations where strategy implementation will be particularly challenging, and to establish appropriate contingency plans. failure in just one country could be catastrophic for an eradication effort. however, other international health goals might be similarly compromised. for example, the emergence of multidrug-resistant strains of tuberculosis in one country could hamper worldwide efforts to combat that disease. similarly, uncontrolled use of antibiotics in a few countries could seriously affect international work to contain antimicrobial resistance. as the poliomyelitis eradication programme began to be implemented on a truly worldwide scale in the mid- s, substantial attention was given to the ten countries that had been identified as at particularly high risk for delaying global eradication. as a result of focusing additional human, financial, and political resources in these areas, five of those countries (bangladesh, the democratic republic of the congo, sudan, ethiopia, angola) now seem to have eradicated poliomyelitis, and only three (india, nigeria, pakistan) continue to have high-intensity transmission. although it is tempting to suggest that even greater attention earlier in the programme might have accelerated progress in these areas, the reality is that scant resources necessitated a more pragmatic approach. other international health goals will require a similar, pragmatic approach to achieve and secure gains where possible, while developing the necessary political, financial, and human resources to address the most challenging areas. contributors r b aylward wrote the introductory, status, and lessons sections, and edited the manuscript. s england developed the concept and original structure and wrote the first draft of the manuscript. m agocs did research, in particular on the background, history, and indirect benefits of poliomyelitis eradication, and wrote those sections. a acharya did the cost-effectiveness analysis. j linkins did the analysis of the direct national and international costs of poliomyelitis eradication and wrote the section in which they are detailed. none declared. macroeconomics and health: investing in health for economic development: report of the commission on macroeconomics and health. geneva: world health organization the globalization of public health, i: threats and opportunities the global fund to fight aids the intensified public health the lancet • geneva: world health organization donor responsibilities in rolling back malaria a paradigm for international cooperation: the global alliance for vaccines and immunization (gavi) and the vaccine fund who framework convention on tobacco control: a global "good" for public health health is wealth communicable disease control: a global public good perspectiveworking paper. geneva: world health organization global public goods: international cooperation in the st century global eradication of poliovirus: history and rationale report on the international conference on 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kotara, sussann; jones, barbara; shanor, donna; nemeroff, charles b. title: a health care workers mental health crisis line in the age of covid‐ date: - - journal: depress anxiety doi: . /da. sha: doc_id: cord_uid: dcxp lb introduction: the covid‐ pandemic has brought a health care crisis of unparalleled devastation. a mental health crisis as a second wave has begun to emerge in our front‐line health care workers. objective: to address these needs, the healthcare worker mental health covid‐ hotline, based on crisis intervention principles, was developed and launched in weeks. methods: upon reflection of why this worked, we decided it might be useful to describe what we now recognize as ‐steps which led to our success. the process included the following: ( ) anticipate mental health needs; ( ) use leadership capable of mobilizing the systems and resources; ( ) convene a multidisciplinary team; ( ) delegate tasks and set timelines; ( ) choose a clinical service model; ( ) motivate staff as a workforce of volunteers; ( ) develop training and educational materials; ( ) develop personal, local, and national resources; ( ) develop marketing plans; ( ) deliver the training; ( ) launch a hr/ days per week healthcare worker mental health covid‐ hotline, and launch follow‐up sessions for staff; ( ) structure data collection to determine effectiveness and outcomes; and ( ) obtain funding (not required). discussion: we believe the process we used is specifically useful for others who may want to develop a covid‐ hotline services for health care workers and generally useful for the development of other mental health services. conclusion: we hope that this process may serve as a guide for other heath care systems. recognized by the steve hicks school of social work, university of texas, the local chapter of nami, and community therapists. some of our covid- hcws are psychologically crashing; all are frightened, yet many do not ask for help. they are exhausted, not sleeping, some crying, all traumatized by dying and death, and vicariously traumatized by suffering families unable to visit with their terminal loved ones. some work in a dissociated state, many drink, or use drugs, while others may contemplate or commit suicide. the healthcare worker mental health covid- hotline was developed to provide crisis counseling by utilizing the expertise of psychiatrists, clinical social workers, psychiatric residents, and volunteer mental health professionals. we envisioned that the hotline could alleviate some hcws stress, and enable our frontline staff to continue working. this paper was written in the hope that our experiences setting up this hotline may be useful to others wanting to offer similar services. we focused on the perceived needs of hcws within dell medical school community and ascension/seton hospitals and affiliates. the near future goal was to serve the entire community. for us, this service developed organically with capable leadership, a cadre of interested and talented innovators and administrators. we spoke and e-mailed frequently, worked both independently and jointly in unstructured cycles. we set urgent timelines, developed what we needed, used existing resources, contracted with one external vendor for hotline technology, and launched. upon reflection of our process and lessons learned, we decided it might be useful to describe what we now recognize as elements of our success. we thought describing the process of setting up this service might be specifically useful for others who may, wanted to develop covid- hotline services and perhaps generally useful for the development of other mental health services. watching the covid- assault on our hcws, while also feeling our limited ability to help medically, we wanted and needed to take action. based on our collective awareness of mental health needs post september (rosoff, ) , mental health needs post other epidemics (kisely, warren, mcmahon, dalais, & henry, ) , local information (meadows mental health institute white paper, ), and the united nations policy brief: covid- and the need for action on mental health ( ), we anticipated there would be a similar local need. it was also immediately clear, by contact with our colleagues, that the needs were both acute and long-term because the pandemic was going to be a marathon event. . | use leadership capable of mobilizing the systems and needed resources quickly informal discussion led to our agenda, tasks, and assignments. leadership obtained medical school approvals to launch the service. an administrator was given the monetary resources and tasked to find and contract with an outside vendor to supply the hotline technology. clinician educators volunteered to research a clinical model and develop, offer, and disseminate the training. psychiatric residency training and social work mobilized the voluntary workforce and arranged the / on call-schedule. social work organized the resource guide, lists of national hotlines, and web-based community resources. educators reviewed clinical models for the service and developed a list of evidence-based phone applications that might be useful to callers. lessons learned from the new york / experience (rosoff, ) taught us that a second wave of mental health crises would occur after an initial onslaught. the severe acute respiratory syndrome outbreak produced anxiety, social dysfunction, acute trauma, and posttraumatic stress disorder in hcws (klitzman & freudenberg, ; williams & gonzalez-medina, hcws were at greatest risk as were junior clinicians, parents with young children, hcws who lacked support or who had an infected family member, needed quarantine, or suffered from virus-related stigma. hcws with access to personal protective equipment, rest, regular information, and those who had psychological support had reduced morbidity. we reviewed trauma-focus, problem-oriented, brief counseling interventions geared toward building the hcws support systems and the use of community resources. inasmuch as there was no established evidence-based treatment model that covers all of these domains, we relied on clinical wisdom and experience using the crisis intervention and counseling approach (caplan, (caplan, , feinstein & collins, ; lindemann, ; salmon, ) . the public media about the pandemic motivated our workforce for us. providing our mental health professionals with a new clinical service, access to participate in a service that was practical, accessible, and meaningful was all the additional motivation needed. it was apparent that we could easily mobilize our psychiatric residents, fellows, faculty, and volunteer/mental health professionals. we developed our workforce by word-of-mouth and by e-mailing our grand round lists to gather interested professionals. our training focused on the basics of crisis intervention. we did not include suicide and violence prevention or addiction screening/assessment, as our mental health professionals were already experienced with these interventions. the crisis didactic training (feinstein & collins, ; feinstein & snavely, ) . see figure s , for a review of crisis intervention theory and outcomes. the clinical approach taught to our mental health professionals was complemented with a brief "tip sheet for crisis counseling" and a book chapter (feinstein & collins, ) . this approach included: (a) listening to the caller's feelings, emphasizing the caller's strengths (hootz, mykota, & fauchoux, ) and focusing on the "why now?" of the call. the social readjustment rating scale (holmes & rahe, ) is a useful list of common precipitants of a crisis; (b) understanding the meanings of the stressors, in the context of the caller's life. (c) uncovering the -week timeline of events that led up to the call, see figure s , a -week timeline. (d) developing an ecological map (greene, ) . this is a representation (feinstein & snavely, ) which includes the caller's complete family genogram, network of other helpers (e.g., physicians, faith-based support, neighbors, friends), and community and national resources, see figure s . the ecological map is used to help view and determine what people or resources are available, interested and competent to help a caller. (e) it is essential to focus on one major problem, progress to a list of contributing problems, prioritized these in order of urgency, and link each problem to a specific solution. a wheel and spoke diagram depicts this process (feinstein & collins, ; see figure s ). (f) in addition, using problem-solving therapy (haley, ) integrated with crisis intervention is important to discover maladaptive coping styles and encourage adaptive problem-solving (feinstein & collins, ; see table s ). (g) we also utilized a -step crisis resolution strategy as a guide for crisis counselors which can also be used as a self-help strategy by callers' after the initial hotline contact (see table s ). the crisis counselor and the caller jointly determine which personal resources may help and other assistance that may be provided by local community or national resources. this begins by choosing resources from the caller's ecological map. we used existing resource guides, developed by social work and population health. our educators local and national websites served as additional resources for our callers. we also developed a list of evidence-based phone applications (bakker, kazantzis, rickwood, & rickard, ; marshall, dunstan, & bartik, ) that might be useful to callers (see table s ). we used local medical school publications, our own website, and social media to get the word out. media outlets will be used in the future. the training was delivered online to participants via zoom. the didactic/theoretical material was presented in min; min feinstein et al. | was left for questions and answers. as noted above, a brief tips sheet and one book chapter (feinstein & collins, ) was also distributed via e-mail to all volunteers. the zoom presentation was recorded and also distributed for asynchronous viewing for volunteers who could not attend the initial training. the service was launched in weeks. we circulated different frequently asked questions (faqs) about the service available to our hcws and crisis callers. we continue to develop and update these growing lists of faqs. we also scheduled regular weekly online zoom drop in sessions for mental health crisis counselors who needed additional support or had other questions. shortly after the launch, we developed a data collection process to be used to determine our ultimate effectiveness and outcomes. this data will be presented in a follow-up publication. our leadership was also able to obtain some funding from a local foundation with which we were already working with and was able to obtain some private donations as well. these are welcomed but were not required to launch the hotline. we used a coherent, useful, and successful approach to developing a covid- mental health hotline in our efforts to prevent an emerging mental health crisis in our front-line hcws. we describe the -step process which we believe led to our success. we described the process of setting up this service with the hope that it might be specifically useful to others who may want to develop covid- hotline services, and perhaps as a generally useful process for the development of other mental health services. mental health smartphone apps: review and evidence-based recommendations for future developments an approach to community mental health principles of preventative psychiatry crisis intervention & trauma & disasters crisis intervention, trauma, and intimate partner violence ecological perspective: an eclectic theoretical framework for social work practice problem-solving therapy the social readjustment rating scale strength-based crisis programming: evaluating the process of care occurrence, prevention, and management of the psychological effects of emerging virus outbreaks on healthcare workers: rapid review and meta-analysis implications of the world trade center attack for the public health and health care infrastructures symptomatology and management of acute grief the digital psychiatrist: in search of evidence-based apps for anxiety and depression mental health services required after disasters: learning from the lasting effects of disasters the ethics of care: social workers in an influenza pandemic. social work in health care war neurosis (shell shock). military surgery covid- and the need for action on mental health infectious diseases and social stigma a health care workers mental health crisis line in the age of covid- we wish to acknowledge james baker, md and catherine stacy, the authors declare that there are no conflict of interests. http://orcid.org/ - - - charles b. nemeroff http://orcid.org/ - - - key: cord- -bc q swu authors: nicholls, stephen j.; nelson, mark; astley, carolyn; briffa, tom; brown, alex; clark, robyn; colquhoun, david; gallagher, robyn; hare, david l.; inglis, sally; jelinek, michael; o’neil, adrienne; tirimacco, rosy; vale, margarite; redfern, julie title: optimising secondary prevention and cardiac rehabilitation for atherosclerotic cardiovascular disease during the covid- pandemic: a position statement from the cardiac society of australia and new zealand (csanz) # date: - - journal: heart lung circ doi: . /j.hlc. . . sha: doc_id: cord_uid: bc q swu abstract background the coronavirus disease (covid- ) pandemic has introduced a major disruption to the delivery of routine health care across the world. this provides challenges for the use of secondary prevention measures in patients with established atherosclerotic cardiovascular disease (cvd). the aim of this position statement is to review the implications for effective delivery of secondary prevention strategies during the covid- pandemic. challenges the covid- pandemic has introduced limitations for many patients to access standard health services such as visits to health care professionals, medications, imaging and blood tests as well as attendance at cardiac rehabilitation. in addition, the pandemic is having an impact on lifestyle habits and mental health. taken together, this has the potential to adversely impact the ability of practitioners and patients to adhere to treatment guidelines for the prevention of recurrent cardiovascular events. recommendations every effort should be made to deliver safe ongoing access to health care professionals and the use of evidenced based therapies in individuals with cvd. an increase in use of a range of electronic health platforms has the potential to transform secondary prevention. integrating research programs that evaluate the utility of these approaches may provide important insights into how to develop more optimal approaches to secondary prevention beyond the pandemic. human transmission of infection with the novel coronavirus, known as covid- , appeared in wuhan in december and has rapidly spread to become a global pandemic. the consequent acute respiratory syndrome has placed a considerable strain on healthcare systems, resulting in significant morbidity and mortality [ ] . even in countries which have been able to limit the number of individuals infected with covid- there has been a seismic shift in traditional platforms for health care delivery in an effort to reduce community transmission [ ] . although the major attention of coronavirus infection from a clinical perspective has focussed on the respiratory complications, there are likely to be considerable cardiovascular implications for those with cvd, and sequelae from the pandemic [ ] . early-stage case fatality rates for those with underlying health conditions in china were highest for cvd ( . %) and more than ten times that of those without cvd [ ] . it is also recognised that up to % of patients hospitalised with acute respiratory illness with coronavirus develop either myocarditis, myocardial injury, arrhythmia or venous thromboembolism [ ] . however, the potential cardiovascular complications of the pandemic will almost certainly be wide-reaching beyond these direct cardiac effects. efforts to reduce social contact and community concerns regarding potential transmission have led to reduction in emergency department presentations for acute coronary syndromes by more than % [ ] . these patients miss the opportunity to receive evidence-based interventions with demonstrated protective effects on future cardiovascular events and death. furthermore, in the patient with established atherosclerotic cvd, changes in access to the health care system has potential implications for high risk patients to receive secondary prevention strategies. this is important given that patients with coronary heart disease have between - % absolute risk over years of experiencing a new heart attack, stroke or cardiovascular death [ , ] , with the greatest risk occurring during the first year following hospitalisation for acute coronary syndrome [ ] . given the concern regarding the long-term cardiovascular sequelae of the coronavirus pandemic, the cardiac society of australia and new zealand (csanz) thought it appropriate to define the potential impact on the effective use of secondary prevention and cardiac rehabilitation and to make recommendations for patients and health care workers. this 'living document' reflects the current state of knowledge and recommendations and should be read in conjunction with up-to-date advice from state and federal health departments. randomised controlled trials of pharmacological strategies have repeatedly demonstrated reduction in the risk of recurrent cardiovascular events in patients with established cvd. consequently the use of antiplatelet, blood pressure, lipid and blood glucose lowering agents, which complement lifestyle modification and attention to psychosocial risk factors are recommended in national and international guidelines [ ] . for patients discharged with a recent acute coronary syndrome, referral to cardiac rehabilitation has also been demonstrated to promote medication adherence and more optimal risk factor control. in the covid- setting, optimal uptake and availability of secondary prevention measures is likely to be impaired as patients avoid or are unable to attend in-person medical clinics and rehabilitation programs. therefore, it is critical to emphasise to both patients and health care professionals that evidence-based routine care works and should continue to be promoted. this has implications for continuing use of secondary prevention therapies and attainment of guideline-advocated treatment goals. accordingly, every effort should be made to lower and manage cholesterol and blood pressure, and use anti-platelet agents, in these high-risk patients, which will require ongoing efforts to maintain adherence with therapy and monitoring of risk factor control. furthermore, increasing evidence for the benefits of (sglt ) inhibitors and (glp- ) receptor agonists in patients with diabetes and established vascular disease supports the need to maximise their use [ ] . this guidance to maintain use of evidence-based therapies is particularly important with respect to the use of agents that target the renin angiotensin aldosterone system (raas). while the established interaction between the covid- virus and ace- has raised speculation with regard to the impact of the use of raas blockers in the setting of covid- viral infection, there is currently no evidence to support the need to stop these agents [ ] . australians are worried about the risk of covid- infection at medical clinics [ ] . similarly, patients appear to be avoiding attending pathology collection centres for tests and pharmacies for their medications. although telehealth services are now more widely available, many patients may not know how to access health care workers via this service. patients with chronic diseases such as cvd and diabetes can now have medicare-funded medical consultations by telephone or videoconferencing. this enables doctors to arrange prescriptions to be faxed, and subsequently posted, directly to the patient's chosen pharmacy. pharmacies in turn can then deliver patient's medicines directly to their home. similarly, pathology and radiology request forms can be sent directly to pathology collection and radiology centres so patients can have essential tests and monitoring. however, although patients have access to medical advice, testing and medicines, the covid- pandemic is likely to worsen the treatment gap. despite the evidence base supporting the benefits of intensive lipid lowering, many patients needing secondary prevention are treated with either no or low doses of statin therapy. maximally tolerated statin doses should be used regardless of the need for lipid testing. patients may be reluctant to attend either their pharmacy or medical clinic to have their blood pressure measured. efforts should be made to encourage patients with elevated blood pressure to access a validated blood pressure monitor for home use. clinics may also be able to lend out such devices or individuals can purchase them independently online or from pharmacies (health care insurance may cover the cost). for disadvantaged patients, additional government payments to social security, veteran and other income support recipients and eligible concession card holders could cover the cost of a monitor. similar arrangements can be made to support the use of home glucometer for patients with established type diabetes. international guidelines for the care of cvd patients during the covid- pandemic includes advice to address cvd risk factors and promote recovery [ ] , and cardiac rehabilitation programs have well-established efficacy for supporting patients with lifestyle change [ ] . current social distancing restrictions substantially limit conventional methods of support for lifestyle change such as attending gyms and participating in group exercise programs. on the flip side, social distancing may also provide an opportunity to focus on positive lifestyle changes. the heart foundation provides guidance for health professionals [ ] , and patient-focussed resources suitable for different levels of health literacy [ ] . smoking presents a significant risk for the cvd patient during the covid- pandemic. in addition to promoting a greater risk of future cardiovascular events [ ] , smoking also increases the risk of infection via hand-to-mouth contact[ ], provides a potential adhesion site for the covid- virus through upregulation of angiotensin-converting enzyme- receptors [ ] , and associates with more severe pulmonary complications [ ] . it is also possible that social distancing strategies may increase loneliness and reduce opportunities for positive coping strategies, which may result in greater rates of smoking and relapse in those who have previously quit [ ] . it is therefore strongly recommended that all smokers with cvd should be informed of these risks and offered evidence-based assistance to quit, including nicotine replacement therapy and other pharmacological interventions. guidelines for exercise and physical activity are unchanged during the context of covid- , with general recommendations of minutes per week of at least moderate intensity exercise, including at least two sessions of resistance or strength exercise, with appropriate modifications in the setting of comorbidities [ ] . current social distancing restrictions have afforded increasing opportunities for walking and other forms of exercise within close proximity to home. for those who need to self-isolate at home, efforts should be made to exercise within or outside their residence, making a priority of keeping active through household tasks and avoiding long periods of sitting. advice and activity plans are available online [ , , ] , with additional support provided through telehealth [ ] and use of activity trackers [ ] . engaging household family members can provide additional support for development and maintenance of exercise regimens. covid- also presents no new dietary recommendations for the cvd patient but is associated with a number of challenges. social distancing requirements may result in change to healthy eating routines, including shopping, meal preparation and food choices. given that poor nutrition and obesity have been identified to associate with poor outcomes in the setting of covid- [ ] , efforts to maintain a healthy diet are worthwhile. older or isolated individuals may have limited or no access to grocery stores and may rely on family, neighbours and home delivery services. those who are particularly vulnerable to poor access to food and need assistance with meal preparation should be referred to relevant local social support organisations for meal delivery, so that nutrition is maintained during the period of isolation. exposure to extreme mental and emotional stress are established cardiovascular risk factors [ , ] . early evidence of the direct and indirect psychological consequences of covid- , both from the infectious disease and associated public policy is emerging [ ] . the current pandemic and social distancing requirements are associated with considerable fear in the community largely due to the evolving nature and uncertainties, particularly where risk of illness and death are substantial [ ] . such anxieties can motivate suboptimal behavioural changes that can shape population cardiovascular health in ways that may have unintended consequences, including disengagement with the health care system or treatment non-adherence. the excess risk of covid- in patients with cvd may exacerbate emotions such as fear, anxiety, vulnerability, helplessness, hopelessness, trepidation or thoughts of mortality experienced by many following an acute coronary syndrome [ ] . perceived or actual loss commonly results in depression and is more prevalent in cvd patients [ ] . potential financial uncertainty combined with isolation for an unknown or indefinite period, especially the elderly, can induce rumination and maladaptive thought processes and contribute to feelings of loneliness. in china, life satisfaction declined over the covid- outbreak period [ ] . periods of extreme stress including natural disasters or economic hardship present vulnerabilities that can also exacerbate family violence including alcohol, drug taking and financial stressors [ ] . both family violence perpetration and victimisation and maladaptive or dysfunctional relationships directly impact one's cardiovascular system and likely elevate long term cvd risk [ ] . maladaptive behavioural responses such as neuroticism or extreme hypervigilance during infectious disease outbreaks may exaggerate or induce compulsive behaviour. this may include obsessive monitoring of media, social media, hand washing or other compulsive behaviours. case reports have emerged documenting brief psychotic episodes during the covid- outbreak [ ] . understanding the mental health implications of this pandemic moving into the post-covid era will also be critical in the context of cvd management. covid- related anxieties or unwillingness to 'burden' the health care system may persist, resulting in continued health service avoidance, disengagement and non-compliance with selfmanagement regimes. this could result in missed cardiovascular or psychiatric medication scripts, referrals to psychologists, specialists or other allied health professionals that promote cvd self-management. increasing caregiver burden and life events characterised by extreme distress or grief, including relationship breakdown, can increase risk of takotsubo cardiomyopathy [ ] . for those with existing cvd who also develop covid- , recovery will need to occur in parallel with ongoing secondary prevention. this has enormous implications for the psychosocial sequelae and rehabilitation of these patients. it has been known that cardiac rehabilitation results in improved psychosocial outcomes [ ] . the inclusion of psychosocial interventions as part of routine heart health checks, cardiac rehabilitation, and the promotion of established mental health services is warranted. early evidence from china suggests that establishment of external emergency mental health expert teams and provision of online public education, psychological counselling and hotline services may have helped to buffer some of the negative mental health outcomes associated with covid- [ ] . the need to expand upon and support these services in the post-covid era, especially in rural and remote settings, will play a critical part of longer-term cvd management. secondary prevention and ongoing care of patients with cvd must continue during the covid- pandemic. the core elements include assessment, information, individualised care and ongoing support, and these can be delivered via a variety of formats including expansion of telehealth options [ ] . most face-to-face health services and groupprograms, including cardiac rehabilitation, have been closed. however, many services have adapted to enable ongoing care and the australian government has expanded telehealth can make care more accessible and affordable and has the potential to reduce disparities in access to care for rural, regional and remote areas [ ] , and for vulnerable populations (people with disabilities, aboriginal and torres strait islanders, the elderly, non-english speaking backgrounds and low socioeconomic groups) [ ] . benefits include: convenience for people in the workforce; reducing transport costs; improved safety through continuous, remote monitoring; increased patient decision-making and self-care increased access to care; improved medication adherence; and, increased cross-provider communication and potential for integrated care [ ] . a recent systematic review found that telehealth secondary prevention can be used instead of, or in combination with, cardiac rehabilitation, and is associated with better risk factor control and less clinical events [ ] . a range of formats of telehealth delivery, including use of telephone communication, internet websites, smartphone applications [ ] , and text messaging, have been developed. examples of these approaches include the telephone-based programs used nationally (the coach program [ , ] ), and those directed to patients living in regional and remote areas (catch [ ] ), the textme program [ ] , and consumer apps for medication adherence and cardiac rehabilitation (e.g. medapp-chd [ ] and cardihab [ ] ). wearable devices, such as activity trackers and smart watches, have demonstrated potential for patients to monitor behaviours such as physical activity and heart rate [ ] , and are being evaluated with regard to their potential integration into clinical practice. the national heart foundation of australia also has established programs that enable patients to receive personalised support for heart-healthy lifestyle strategies by telephone or email [ ] . this has been complemented by a current media campaign highlighting the need for ongoing attention to prevention measures in those deemed to be at high risk of a cardiovascular event. in parallel, social media has provided an important platform for a range of professional societies to reinforce the need for patients with cvd to continue with secondary prevention. • the most important message is that patients with existing cvd must continue to receive management and support. • all recommendations should be applied in conjunction with contemporary advice from commonwealth and state public health officials. • patients with established cvd are at the greatest risk of future cardiovascular events. in the setting of chest pain, recommendations of seeking emergency medical attention remain important. • all efforts should be made to take advantage of a range of telehealth formats to ensure as many patients as possible have access to health care professionals. consideration should be made on how best to interact with patients, depending on their access and familiarity with these different technologies. • similar e-health strategies should be used to continue to deliver evidenced based therapies to patients in secondary prevention. • the emergency e-health responses are welcomed, and a strong argument should be to retain these initiatives in practice after the pandemic. • all preventive therapies should be continued by patients with every effort made to monitor risk factor control. consideration should be made regarding potential barriers for patients to access prescriptions, imaging, blood tests, blood pressure measurement and referral to cardiac rehabilitation. it has never been more important to avoid under-treatment of patients. • the inclusion of psychosocial interventions as part of routine heart health checks, cardiac rehabilitation, and the promotion of established mental health services is warranted. • consensus statements should support the initiation and use of ace inhibitors and angiotensin receptor blockers in cvd patients in the setting of the covid- pandemic unless contrary evidence emerges. • all patients should receive the influenza vaccine unless they have a specific contraindication to its use. • in an era of integrating new processes into routine clinical care, there is an important opportunity to evaluate their efficacy and cost effectiveness. this will have implications for their longer-term use beyond the pandemic. cardiovascular considerations for patients, health care workers, and health systems during the coronavirus 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for universal health coverage (uhc) have led many countries to implement health sector reforms, however, since the global recession, economic growth has slowed in many lower-income and middle-income countries. in a renewed interest in public financial management (pfm), international organisations have emphasised the importance of giving spending control to those responsible for healthcare. however, centralisation is a common response when there is a need to cut expenditure due to a reduced budget; yet failure to decentralise often hampers the achievement of important goals. this paper examines the effect of centralising financial decision-making on the functioning of the south african health system. methods: we used a case study design with an ethnographic approach. primary data collection was conducted through participant-observation and semistructured interviews, over year. member checking was conducted. results: new management implemented centralisation due to a reduced budget, a history of financial mismanagement, the punitive regulatory environment financial managers face, and their fear of poor audit outcomes. the reform, together with an authoritarian management style to ensure compliance, created a large power distance between financial and clinical managers. district managers felt that there was poor communication about the reform and that decision-making was opaque. this lowered commitment to the reform, even for those who thought it was necessary. it also reduced communal action, creating an individualistic environment. the authoritarian management style, and the impact of centralisation on service delivery, negatively affected planning and decision making, impairing organisational functioning. conclusion: as public health systems become even more financially constrained, recognising how pfm reforms can influence organisational culture, and how the negative effects can be mitigated, is of international importance. we highlight the importance of a participatory culture that encourages shared decision making and coproduction, particularly as countries grapple with how to achieve uhc with limited funds. in the last decade, international calls for universal health coverage (uhc), coupled with the sustainable development goals' inclusion of uhc, has led many countries to implement health sector reforms. however, fiscal space for public services has narrowed during this period given the recession, leading to a renewed interest in public what is already known? ► health systems are facing demands for improved access to care in the context of constrained fiscal space. ► decentralisation of financial control to managers responsible for service delivery should, in theory, improve the use of funds. what are the new findings? ► a fear of poor audit outcomes can lead finance managers to hold onto financial control; this fear is exacerbated in austerity climates and in systems with a history of financial mismanagement. ► finance and clinical managers often do not have a shared vision of the goal of the health system, and this drives tension and impacts negatively on relationships. ► this leads to an organisational culture that is competitive and dismissive of the needs of the collective. ► this further weakens the health system. ► austerity can lead to radical public financial management reforms to attempt to control expenditure. ► finance and clinical managers need to find more opportunities to coproduce the shared goals of the department to ensure policy reform is aligned to systems goals-this can be done through multidisciplinary committees. ► relational accountability, which is fostered by working more closely together, can increase acceptability of decentralised control, which would improve participation and ultimately health systems functioning. financial management (pfm), given its intention to support service delivery, while controlling expenditure. the world bank and world health organization (who) have re-emphasised the importance of giving spending control and flexibility to those responsible for healthcare such as facility managers and district health offices (dhos). the aim of this decentralisation is to achieve more efficient use of funds. the reasons why this shift in control has not been widely implemented vary from a lack of capacity at the lower levels of the health system, to poor accountability mechanisms. centralisation of financial decision making is in fact a more common response when there is a need to cut expenditure in line with a reduced budget. it is also likely to be a widespread response to the austerity that will follow the covid- pandemic. however, failure to decentralise decision-making is likely to hamper the functioning of health systems, constraining their ability to maximise value from limited resources. since the global recession, south africa (sa), like many other lower-income and middle-income countries (lmics) has been experiencing low, or no, economic growth. the government has instituted widespread austerity measures, particularly to reduce the public sector wage bill. in , the south african national department of health (ndoh) announced its intentions to implement uhc, through a national health insurance (nhi) scheme. as a result, the health system is grappling with how to responsibly manage public funds while responding to the new uhc policy goals, a problem that has come to the fore in many lmics. in this paper, we examine the effect of centralising financial decision making on the functioning of a south african provincial department of health (pdoh), in an environment of health system reform. country context sa is a middle-income country with a federal system of government. until financial year / , sa had been able to largely protect its social services sectors (eg, health, education) from the effects of slower economic growth and a decline in tax revenue. however, since , this has no longer been possible and the social sector has been negatively affected by declining budgets in real terms, despite an increasing burden of disease. the austerity climate in the country has substantially worsened since , due to attempts to recover from a period of widespread corruption. sa has a quadruple burden of disease which increases the need for health services. however, quality of care remains poor due to insufficient budgets and ineffective use of funds. sa has an ndoh, nine pdohs and dhos. figure illustrates the levels and responsibilities of the health system and shows that it is the responsibility of the pdoh to delegate financial decision-making to districts and facilities. sa's health sector has a long history of trying to decentralise governance to the dhos, with the national treasury and the ndoh encouraging pdohs to deconcentrate power. most of the pdohs have experimented with 'delegations', which legally allows a lower level official to be responsible for a task that has been assigned to a more bmj global health senior manager. however, the use of delegations remains limited. with nhi, the ndoh plans to shift financial accountability away from provinces to districts, essentially forcing decentralisation onto the health system. since the s, the field of organisational management has studied how people influence their organisation's performance. 'organisational culture' (oc), a theoretical construct within organisational management science, is generated as an organisation performs its functions, creating a pattern of shared assumptions. this culture governs the way people perceive, experience and, in turn, influence how the organisation functions. oc can answer questions about how decisions are made and offer possible reasons for why implementation is difficult despite an organisation having all the requisite infrastructure and resources ('hardware'). oc is often seen as the connector between individual and collective behaviours and therefore is a useful paradigm when trying to analyse systemic policy failure. within health systems and policy research, it is widely accepted that the functioning of a health system is influenced by the people working within it, and their relationships ('software'). however, framing this phenomenon using oc is relatively new in the field. therefore, a recent synthesis of evidence by mbau and gilson ( ) has been valuable in determining an analytical framework through which to analyse oc in lmic health systems. their framework illustrates the ways in which oc influences organisational functioning in lmics (figure ). the framework contains two layers: 'dimensions of culture' and 'organisational practices'. table describes the dimensions of culture (we have renamed three of the dimensions for clarity), and table the organisational practices. the dimensions and practices are interrelated. for example, managers, afraid of poor outcomes, may adopt an authoritarian management style to avoid uncertainty and control outcomes, resulting in a large power distance between managers and employees. a participatory management style, on the other hand, increases managers familiarity with the lower levels of the organisation, and so can reduce their fear of uncertain outcomes by improving their understanding of the challenges at lower levels. the resulting collective uncertainty avoidance degree to which the members of an organisation avoid unknown outcomes by depending on accepted practices, rules, or procedures. power distance the difference in (decision-making) power between higher and lower levels of an organisation, and whether that power difference is found to be acceptable and appropriate. institutional collectivism extent to which the organisation encourages and rewards communal action (working together). in-group collectivism level of pride, satisfaction and loyalty shown by members towards their organisation. process facilitates better communication and feedback, increasing participation in decision making. it also fosters communal action across, and commitment to, the organisation. we used a case study design, with ethnographic methods. these methods are appropriate when looking to explain 'how' or 'why' events happened, and health systems actors' perspectives on them. case studies are particularly valuable for research looking to understand oc within a particular setting, like a pdoh. case studies allow for holistic research within the real context of the participants. it therefore pairs well with ethnography, which aims to understand the reality of participants from inside their context. study setting and negotiating access the pdoh studied is situated within a poor, predominantly rural province in sa. it has a long history of financial mismanagement and is one of the poorer performers in the country in terms of service delivery. the province has experimented with widespread delegations to the dhos in the past but revoked them due to mismanagement. the austerity measures and pfm centralisation have been in place since . jw had previously worked with the province in her capacity as a health financing specialist and was known to many of the senior and middle managers. she met with one of the senior finance managers to ask whether the pdoh would be willing to participate in the study. from there, the research protocol was shared with the executive management of the province and the pdoh agreed to be involved. informed consent was obtained for all observations, interviews and audio recordings. participant selection jw received informed consent from individuals to be observed and was a participant observer in meetings, which varied from routine financial management meetings to meetings with hospital chief executive officers (ceos) at their facilities. in these meetings, she was allowed to ask questions and provided technical advice when invited to do so. jw used purposive sampling for her interviews, contacting employees responsible for financial and clinical management at the pdoh head office, dhos and public hospitals. she then used snowball sampling either through the introductions made at meetings or through a referral by an interviewee. no one explicitly refused to participate in the study, however, some never responded to several requests for an interview. she conducted interviews (table ) . data collection ran from july to june . at the start of data collection, jw attended two -day meetings to introduce the research to key stakeholders. jw collected all the data for the research. data collection was conducted using participant observations and semistructured interviews. data were collected by visiting the province for several days at a time. during these visits, jw attended meetings and conducted in-person interviews. the majority of the observations and interviews took place either within the head office, dho or a public hospital. for the observations, jw used an observation guide to make detailed meeting notes. a semistructured interview guide was used for data collection. jw used a 'grand tour' approach. grand tour is useful when you want to elicit a thick description within case study research. the grand tour questions were adapted for interviews at the different levels of the communication and feedback the extent to which, and how, staff are informed about policy reform processes. authoritarian (most negative), consultative or participatory (best practice) management. to what extent employees across the system are involved in decision making. commitment the extent to which employees support the reform. bmj global health health system. the questions were designed to prompt participants to share their experiences in their own words. some of the questions included: 'describe your average workday' and 'tell me about a time you interacted with the pdoh and how that impacted you'. interviews ranged from min to over an hour. no one else was present at the interviews. only one participant refused to be audio recorded; he felt this was necessary to be able to participate fully. while repeat interviews were not conducted, the researchers did amend the interview questions during data collection to take into account knowledge already gained from previous interviews and observations. the authors discussed when no new information was emerging and determined data saturation had been reached. data analysis jw wrote up her observation notes after each interaction. the audio files were deidentified and transcribed by an external company, and then checked for accuracy. the authors read the data, with jw coding the data according to common themes, following which the authors discussed the emergent codes. jw then analysed the codes and grouped them into high-level themes. the authors interrogated these themes, discussing the strength of the evidence for each. we selected mbau and gilson's ( ) framework as a useful way to frame the data. we used dedoose to deductively recode the data, using themes from the framework, with a total of eight codes (four dimensions of culture and four organisational practice codes). identifiers are used to anonymise the quotations. we used 'i' for data gathered via an interview, followed by either a 'p' for pdoh, 'd' for dho or 'h' for hospital. observation notes were used to inform the analysis, but we do not use verbatim quotes from these. member checking was done through a participatory workshop to discuss the research findings. the invitation was extended to everyone within the head office, the two dhos studied and the four public hospitals. the workshop was held over day, with all attendees in the same workshop. the workshop was interactive, splitting attendees into groups to consider the research findings. these groups were heterogeneous, with at least one member from the different levels of the health system, as far as possible. attendees gave input on whether the key themes were appropriate and engaged with the findings. the discussions at the workshop contributed to the proposed recommendations in this paper. this, along with the rigorous data analysis methods, have ensured the credibility and confirmability of the findings. reflexivity jw asked participants to clarify the background behind a statement, even though she was familiar with the history. this approach, combined with reflexive note taking and jg's interrogation of the data, enabled jw to separate her perceptions from the respondents' interpretations of events. jw also wrote down her thoughts on the quality of the interview and any insights that emerged. no patients or members of the public were involved in the research design, analysis nor dissemination of the findings; however, provincial managers contributed to the research focus in the planning stages, and provincial, district and hospital managers were involved in the interpretation of the findings. . this has forced managers to purchase services that they do not have the funds for (resulting in accruals), to maintain service delivery: "when you do not have any money left, you just borrow! so, we owe our suppliers from way back!" [ih ]. as accruals from the previous year must be settled first; the impact of austerity is cumulative from one year to the next. a hospital manager highlighted the impact of this narrowing fiscal envelope for service delivery: "at the beginning of the year, we had a r million gap between the authorised budget and expected expenditure, but we were only left with a r million budget shortfall at the end of the year. that means we cut expenditure by r million somewhere, either by reducing services, or compromising the quality of care." [ih ] . over the last decade, the province has been attempting to rationalise the service delivery platform (reduce the number of facilities), to bring down the running costs, but these attempts have been unsuccessful largely due to resistance from surrounding communities who did not want to lose their facility. in addition, the pdoh has experienced a proliferation of 'unfunded mandates' in the pursuit of uhc: "a decision was made that we are [ given their proximity to service delivery: "it's very stressful, […] we are trying to deliver [services] to communities, but one of the major challenges is resource constraints." [ip ]. the province has a history of financial mismanagement and poor audit outcomes: "the district managers were given financial delegations, but they would go out for meetings on consecutive days and they would leave the order books signed, and then anybody who wanted to buy anything would just fill in the particulars!" [ip ]. the national and provincial treasury have had to intervene several times: "if the department can't manage their salary payments, then provincial treasury takes that function away." [ip ] . emulating the treasury's approach, the pdoh tends to revoke financial control from the lower levels when there is evidence of mismanagement. this is implemented across the board, not just for the offending manager: "something small happens, and then they just pull the delegations away! so, it's like a knee-jerk reaction!" [ip ]. since , under new leadership, the pdoh has endeavoured to improve the financial audit outcomes by instituting a radical pfm centralisation reform. they established a 'centralisation committee', which is comprised of financial, clinical and support service managers who meet once a week to review expenditure and payment requests for the whole province. the committee is chaired by the chief financial officer (cfo), and its establishment revoked all delegations from the districts and facilities. members of the committee are senior managers within the head office, with none from the dhos or hospitals. a hospital manager empathised with the rationale for the reform: "i understand why [they instituted this reform], and maybe, i would feel inclined to do the same. health is an underfunded mandate, so, on paper, we try and prevent unauthorised expenditure because the cfo and financial managers will lose their jobs." [ih ] . several finance managers echoed the sentiment that the finance environment was very punitive: "so, if we want to see some bloodshed, one needs to look within the finance department, where i think the greatest amount of correspondence is sent out in terms of financial misconduct and i think that's because treasury has quite vigilant consequence management." [ip ]. power distance, commitment to the reform and effect on relationships clinical managers within the head office reflected on the centralisation of power: "sometimes, when i engage fellow middle managers, i feel that they are not sure of certain decisions […], decision-making power is very much controlled at the executive management level." [ip ]. it was not only clinical managers who felt aggrieved by the centralisation, finance managers in the districts also felt shackled: "i feel like head office are not giving you space. even the district managers, the senior managers, are not given a space to cooperate and prove their worth or their capabilities." [id ]. hospital managers were also dissatisfied: "to be a ceo in the department of health is a nightmare because we are given the responsibility, but you're not given the necessary authority; you don't have the financial delegations to do your job." [ih ]. many managers lamented the inefficiency of the new committee: "it can take a month for the committee to approve an order of a simple item, then there is the procurement, and then we still need the committee to approve the payment! it's a nightmare from the facility's point of view." [ip ] . managers were reluctant to support the reform, even those who felt centralisation was acceptable: "i feel the centralisation committee is necessary, but the committee does delay us. if communication were free flowing with actual turnaround times that are within reason, we wouldn't mind." [id ]. most managers felt centralisation was not the right solution and found it both inefficient and unfair to those who had not transgressed: "[they said] everything had to be centralised. i am saying, 'that is not fair, why are we getting impacted in a negative way, it is not right." [ih ] . clinical managers described the strained relationship between the finance teams and them: "there is a huge discrepancy in understanding our individual roles and our team roles. we feel very strongly, from the clinical branch, that we should give direction, and then they should say how that can be supported. this is now not me alone [that holds this view], that i am sure of! we feel very strongly they are not a support to us. they are dictators." [ip ] . in turn, finance managers bemoaned clinical managers' lack of concern for the constrained fiscal environment: "why are all clinical needs given a much higher priority than staying within the budget, when services cannot operate if we have run out of money?" [ip ]. to try and repair the relationship, the finance team at the head office assured managers that this reform was a short-term necessity to prevent continued financial disrepute. however, there has been no change to the reform in several years: "there has been this verbal commitment to differentiate the delegations, but there has been no follow through. i am told that it is going to happen now, but i have been told it is going to happen for the last year and a bit." [ih ] . once the audit outcomes begun to improve, finance managers cited fear of regression as the reason to maintain the reform: "the delegations have not been cascaded in order to manage the risk of [ however, many clinical managers suggested that agile accountability mechanisms that are able to identify and correct mistakes quickly could help reduce financial mismanagement: "if we are being wasteful or have done it incorrectly, then charge us! we will quickly do the right things!" [ih ]. district finance managers also pushed for delegated control: "they are saying we will mess up the budget, it won't balance, but i don't think that's true, [if there is a mistake] they know where to take that complaint to." [id ]. many managers reported feeling loyal to the organisation: "i love what i do so, maybe that's why, even though it is stressful, there are things that cause you to wake up and come to work. being a provider of a public service is not always easy, but i think passion drives us." [id ]. this was not limited to clinical managers, finance managers felt similarly: "if i look at my job, it's a job that i love, that i'm absolutely motivated and inspired to be doing." [ip ] . this loyalty to the organisation appeared to be a major consideration for managers remaining in the organisation during exceptionally difficult circumstances. however, the lack of a participatory management style affected organisational functioning: "i find the misalignment comes [ in this paper, we have described how centralisation was implemented in response to austerity and financial mismanagement, the punitive regulatory environment financial managers face and their fear of poor audit outcomes. the reform, together with an authoritarian management style to ensure compliance, created a large power distance. managers felt that the committee gave insufficient feedback and that decision-making was opaque. this lowered commitment to the reform, even for those who thought, given the pdohs financial history, the reform was necessary. it also reduced communal action, creating a more 'territorial'/individualistic environment. while many managers expressed their loyalty to the organisation and how this had kept them motivated, the authoritarian management style, and the impact of centralisation on service delivery, had negatively affected organisational planning and decision-making. problems with implementation are often attributed to misalignment and misunderstanding between actors in health systems. many managers in our study reported that the head office was disconnected from the rest of the health system, making them ill suited for centralised control. however, given the fear of uncertainty, finance managers remained wary of financial decentralisation, as is common during fiscally constrained periods, and therefore, the reform has remained in place. different parts of an organisation often have their own subcultures that may be in conflict with one another. however, as long as the subcultures are aligned to the overarching organisational goals, this may not be a problem. studies of hospital wards have explored how a punitive pfm regulatory environment exacerbates the harmful effect of austerity on service delivery, and can lead to irrational purchasing decisions. we have reported on the punitive subculture within the finance teams and the disagreement between finance and clinical teams on the organisation's goals. where spaces for shared decision making were created, clinical managers bmj global health often refused to participate as their contributions were not truly considered, reducing communal action, and impacting negatively on departmental performance. organisations with an authoritarian management style often rely on 'bureaucratic' and punitive accountability mechanisms to ensure adherence to policies. in contrast, 'relational' accountability theory points to the importance of positive supervisory relationships to exist alongside accountability measures for the latter to be effective. if the supervisor has a greater understanding of the challenges the supervisee is facing, a realistic compromise is possible. relational accountability requires a participatory management style and coproduction. changing to a participatory environment can, however, be difficult when an organisation's culture favours 'command and control' and top-down decision making, as seen in the province studied. our recommendations below centre on bringing diverse managers together more often, and in different settings, as a start toward building the relationships (and culture) needed for a functional organisation. sa, like many other lmics, envisions using capitation and similar methods for reimbursement under its nhi, with predetermined limits on what can be spent, and financial accountability shifting to the district health offices. in preparation for nhi reform, managers could use a similar approach, even if just for a discrete list of items, to facilitate the shift to decentralisation. for example, a cost per capita for primary healthcare (phc) services is fairly easy to determine given available data, and the province could decentralise sufficient funds to cover phc visits, to the dhos. this shifts spending power to the lower levels while still maintaining control over the spending ceiling, a core goal for successful pfm. we suggest recommendations (box ) that facilitate engagement and communication across finance and clinical managers, a key challenge especially for lmics who are under the dual pressure of austerity and uhc implementation. in following these recommendations, pfm reforms can be developed collaboratively, which can ensure both reform success and safeguarding of oc and so, an organisation's functioning. as we grapple with the covid- pandemic, the austerity climate is bound to worsen. we need to be mindful of the ways in which austerity and the pfm policies it brings, can impact on oc, and so affect organisational functioning. the world bank group has already started publishing guidance for treasuries on how to be able to respond agilely to the needs of social sectors, for example, by making it easier for facilities to access funds to procure needed goods and by allowing for more real time reporting of available cash. our paper showcases the deleterious effects of a health system that is unresponsive and authoritarian and feeds into this new body of recommendations that call for greater collaboration across finance and clinical managers. the pandemic could further tip the scales of power toward finance managers, as they attempt to control the shrinking public purse. we caution against this and highlight the system benefits of a participatory culture, especially for effective pfm. jws access to managers was linked to her existing relationships and these were mostly with senior managers. this was a possible reason for only four junior managers agreeing to be interviewed. the distance between her home province and the study province restricted how often she could conduct data collection. this was mitigated through longer data collection periods. lastly, the findings are limited to one province; while they cannot be generalised, the experiences documented are similar in other south african provincial departments of health and lmics. the pdohs centralisation reform influenced its oc, reducing opportunities for participatory decision making and polarising finance and clinical managers. this not only hindered reform implementation, but also impacted negatively on the overall functioning of the health system. the pressure placed on the department by the socio-political context of austerity and financial mismanagement, had a direct bearing on reform choice and design. as public health systems become even more financially constrained, alongside the pressure to rollout massive system restructuring to support uhc, recognising the ways in which pfm reform can influence oc, and how the negative effects can be mitigated, is of international importance. for the study setting ► include district managers and hospital chief executive officers in the provincial executive team. ► rotate provincial finance managers through district health offices (dhos) and hospitals to facilitate greater understanding of the challenges on the ground; this will allow for relational accountability. ► rotate the chair of the centralisation committee on a weekly basis. ► invite key stakeholders from the districts and facilities to sit on the centralisation committee, including members of the district centralisation committees, even if on an ad hoc/as possible basis, to build capacity at lower levels, and foster trust between the levels of the health system, in preparation for decentralisation and national health insurance. ► in time, the centralisation committee could determine a list of decisions that could be delegated to district-level committees. the time spent together should provide a foundation for relational accountability, which should improve public financial management. ► finance managers should spend time in facilities and dhos to better understand the reality on the ground. ► the time spent together on the ground would support relational accountability between clinical and finance managers. ► once the relationship between clinical and finance managers begins to strengthen, finance teams should determine an initial list of decisions that can be delegated to the lower levels of the system to support a transition to decentralisation. twitter jodi wishnia @jodi_wishnia aligning pfm and health financing: sustaining progress toward universal health coverage. health financing working paper let managers manage: a health service provider's perspective on public financial management the impacts of decentralization on health system equity, efficiency and resilience: a realist synthesis of the evidence the global financial crisis: experiences of and implications for community-based organizations providing health and social services in south africa health spending at a time of low economic growth and fiscal constraint fiscal space for health: a 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qualitative analysis of health professionals' perceptions in the region of valencia it makes me want to run away to saudi arabia': management and implementation challenges for public financing reforms from a maternity ward perspective accountability mechanisms and the value of relationships: experiences of front-line managers at subnational level in kenya and south africa an assessment of organisational values, culture and performance in cape town's primary healthcare services agile treasury operations during covid- the world bank acknowledgements we would like to acknowledge the pdoh and all participants for their contribution.contributors both authors conceived of and planned the paper. jw is the principal researcher and conducted data collection and primary data analysis. jg reviewed the data analysis results and provided expert guidance. jw was the primary manuscript writer, with jg providing detailed input. both authors approved the final version of the manuscript.funding jw's research is funded by the south african research chair initiative.competing interests none declared.patient and public involvement patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.patient consent for publication not required.ethics approval ethical approval was granted by the university of witwatersrand's human research ethics committee (medical) (m ) and the pdohs research committee.provenance and peer review not commissioned; externally peer reviewed.data availability statement all data relevant to the study are included in the article or uploaded as online supplemental information. all relevant data are included in the paper.open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. jodi wishnia http:// orcid. org/ - - - jane goudge http:// orcid. org/ - - - key: cord- - eh yt authors: stolldorf, deonni; germack, hayley d.; harrison, jordan; riman, kathryn; brom, heather; cary, michael; gilmartin, heather; jones, tammie; norful, allison; squires, allison title: health equity research in nursing and midwifery: time to expand our work date: - - journal: j nurs regul doi: . /s - ( ) - sha: doc_id: cord_uid: eh yt nan t he world health organization (n.d.) named the "year of the nurse and midwife" to both celebrate the contributions of nurses around the globe, recognize the challenges they face, and invest in and increase the nursing workforce. indeed, the first half of the year has brought profound changes and challenges to nursing and midwifery. the covid- pandemic has laid bare the structural inequities inherent in the us healthcare system. the collective "enough!" expressed by the public with regard to racism and discrimination toward black and minority communities further raises the motivation to move our research toward addressing social justice issues. for nursing and midwifery, the time has come to address health equity in all its forms. the interdisciplinary research group on nursing issues (irgni) of academyhealth has agreed to target its efforts in the coming years to address health equity. the irgni looks forward to using its platform to help share the unique perspectives of nurses and midwives in this important field of research. health equity is achieved by eliminating health disparities and inequalities (braveman, ) . many of our fellow researchers use the terms "minority health," "disparities," "inequities," and "inequalities" interchangeably, yet they are conceptually distinct. with that, the irgni has reviewed and will adopt the revised definitions of minority health and health disparities published by the national institute for minority health and health disparities (nimhd). alvidrez et al. ( ) published the revised definitions in a special issue of the american journal of public health. the revised definitions read: nimhd defines minority health as all aspects of health and disease in one or more racial/ethnic minority populations as defined by the office of management and budget, including blacks/african americans, hispanics/latinos, asians, american indians/alaska natives, and native hawaiians/other pacific islanders. nimhd defines a health disparity as a health difference, on the basis of one or more health outcomes, that adversely affects disadvantaged populations. according to the legislation that created nimhd, a health disparity population is characterized by a pattern of poorer health outcomes, indicated by the overall rate of disease incidence, prevalence, morbidity, mortality, or survival in the population as compared with the general population. current nimhddesignated health disparity populations include office of management and budget-defined racial/ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities (which include lesbian, gay, bisexual, transgender, and gender-nonbinary or gender-nonconforming individuals). (p. s ) also important is the concept of healthcare disparities with issues of access and implementation of services that often disproportionately affect minority populations. achieving healthcare equity means equitable access and patient experiences for all. the social determinants of health have also received increasing attention as important factors that can affect anyone at the individual, familial, community, and system levels (carey & crammond, ) . during the year of the nurse and midwife, the irgni advisory committee is looking forward to open discussions regarding health equity and the revised nimhd definitions. we are proud to present this year's collection of irgni research abstracts. this work highlights how nurses and midwives can systematically move toward addressing health inequities, health inequalities, health disparities, and the social determinants of health. these abstracts cross the lifespan and focus on communities of color, understudied populations, and the places where we seek healthcare services. we hope readers will find new insights into the health of populations and their health-seeking behaviors. these findings will inform new directions for research, policy, and regulation and will strengthen the evidence base to dismantle sources of structural discrimination in the u.s. healthcare system. many of the nursing and organizational factors identified in this study that are associated with mnc are actionable. we recommend that nursing administration, nursing leaders, and policy makers consider regularly monitoring mnc as a quality measure and modifying elements of the nursing work environment to decrease the frequency of mnc. to develop machine learning models designed to predict -day and -year mortality for medicare beneficiaries aged years or older treated in inpatient rehabilitation facilities (irfs) following hospitalization for hip fracture. study design: a retrospective design/cohort analysis of the centers for medicare and medicaid services inpatient rehabilitation facility-patient assessment instrument first-admission data were used for , persons admitted to medicare-certified irfs in following hospitalization for hip fracture. independent variables included patient characteristics such as sociodemographic (i.e., age, gender, race, and social support) and clinical factors (i.e., functional status at admission, chronic conditions) as well as utilization (i.e., length of stay). the dependent variables were -day and -year mortality. we trained and evaluated two types of classification models-logistic regression and a multilayer perceptron (mlp)-that used multivariable combinations of patient data described above to predict the probability of -day and -year mortality. four measures were used to determine model performance: (a) accuracy (acc), (b) area under the receiver operating characteristic (auroc), (c) average precision (avg prec), and (d) calibration slope. population: the analytic sample included , hip fracture patients who received postacute care services in , irfs. results: the best predictive model for -day mortality was mlp (acc = . , auroc = . , avg prec = . , slope = . ) versus logistic regression (acc = . , auroc = . , avg prec = . , slope = . ), and for -year mortality was logistic regression (acc = . , auroc = . , avg prec = . , slope = . ) versus mlp (acc = . , auroc = . , avg prec = . , slope = . ). both models showed fair predictive power and performed similarly across all four measures. conclusions: this study presented analysis of prognostic factors of hip fracture mortality using two different machine learning models. although model evaluation suggested that mlp may yield slightly better (although not statistically significant) accuracy when compared to logistic regression, both models have high aurocs and good calibration and can serve as valuable tools for accurately identifying patients with hip fracture at high risk for -day and -year mortality. implications for clinical practice and regulation: logistic regression and mlp models have similar predictive power and may be implemented to reduce cognitive burden. these models can be trained on local data to enhance clinical specificity in mortality prediction so that palliative care resources may be allocated more effectively. author: rachel breman, phd, mph, rn objective: in the united states, approximately one third of births are cesarean. furthermore, cesarean delivery is the most frequent surgical procedure. reducing the rate of cesarean delivery in a generally healthy population of patients is a key focus of efforts to decrease cesarean birth nationwide. previous research suggests that hospital admission in active labor among healthy women can reduce the use of medical interventions and cesarean birth. the purpose of this study was to examine the influence of hospital admission management and maternal sociodemographic factors on labor and birth outcomes among groups of women who were triaged for hospital admission by a rotating staff of midwife versus physician providers. study design: retrospective cohort study. population: low-risk pregnant women with a term gestation fetus in a vertex position (n = ) admitted to a community hospital for labor in by a nurse-midwife (n = ) or physician provider (n = ). results: forty-three percent ( / ) of patients admitted by midwives and % ( / ) of patients admitted by physicians went on to deliver with the same type of provider. patients admitted by midwives had more advanced cervical dilatation ( . cm vs. . cm; p < . ) and effacement ( . % vs. . %; p < . ) at admission and were less likely to receive labor augmentation or epidural ( . % vs. . % and . % vs. . %, respectively) compared with patients admitted by physicians. in multivariate analysis controlling for influence of patient sociodemographic factors, women admitted by physicians were times as likely to have a cesarean birth as those admitted by a midwife. among patients who gave birth in the first hours after triage, the median length of labor in those admitted by midwives was nearly hours shorter ( . hours, iqr = . - . ) than those admitted by physicians ( . hours, iqr = . - . ). in a subanalysis of patients having a vaginal birth, there was no difference in labor length by provider type, but public insurance compared to private insurance was associated with shorter labor duration (median, . hours for public insurance and . hours for private insurance) after accounting for triage provider type, sociodemographic, and labor factors. conclusions: patients triaged by midwives were less likely to experience labor augmentation, epidural, and a cesarean birth compared to similar women triaged by physicians. publicly insured women spent less time in the hospital in labor preceding vaginal birth. implications for clinical practice and regulation: use of midwives in labor triage units may potentially decrease cesarean rates and associated costs. future studies are needed to explore reasons why publicly insured patients who have vaginal birth may spend less time laboring in the hospital and the possible cost implications. % and can cost a hospital up to $ . million annually. other negative consequences of nurse turnover are well documented and include adverse patient outcomes, such as increased falls and mortality rates and decreased satisfaction with healthcare, and adverse nurse outcomes, including increased burnout and decreased job satisfaction. the inability to retain experienced, knowledgeable nursing personnel has detrimental effects on overall healthcare delivery system performance, not only in the civilian community but within the military healthcare system (mhs) as well. the purpose of this study was to conceptually define potentially preventable losses (ppl) and examine the associations between the nursing work environment, job satisfaction, unit characteristics (i.e., medical-surgical vs intensive care units), nursing roles (i.e., registered nurse [rn] and licensed practical nurse [lpn]), and ppl. study design: this descriptive and correlational secondary data analysis uses annual nursing workforce survey data extracted for a multifocus, longitudinal, descriptive, and correlational parent study of the impact of nursing on patient outcomes. the sample for this analysis contains observations from and from from civilian and military rns and lpns employed in u.s. army hospitals. descriptive statistics, correlations, and data mining predictive modeling techniques were used to evaluate the relationships between the outcome variable and the predictor variables. results: ppl further categorizes intent to leave reasons as a result of organizational structure, compensation, or working environment that could have potentially been prevented given timely identification of issues and appropriate intervention. more than % of respondents indicated that they intended to leave their u.s. army hospitals in and . of those that intended to leave, ppl reasons accounted for % of all reasons in both years. dissatisfaction with management, work environment, and personal reasons were the top three ppl reasons why respondents intended to leave, accounting for % of all ppl reasons in and . in , job satisfaction, nurse participation in hospital affairs, nurse foundations of quality care, nurse manager leadership support, staff and resource adequacy, and subscale composite scores were significantly lower for respondents who indicated they were leaving for ppl reasons. results were similar in , with nurse physician relations instead of staff and resource adequacy scores being significantly lower. the random forests model indicated job satisfaction and nurse manager leadership support were the most important predictor variables for ppl in and , respectively. implications for clinical practice and regulation: these findings add to our understanding a conceptual definition of ppl and potentially preventable reasons why nurses in the mhs intend to leave. these findings may also assist in the development of actionable nurse retention strategies and intervention studies to ultimately reduce nurse turnover. authors: jessica g. rainbow, phd, rn; katherine m. dudding, phd, rn; claire bethel, msn, rn-bc objective: the aims of this study were to examine the prevalence, locations, and severity of nurse pain; explore the impact of nurse pain on performance at work; and describe nurse strategies for coping with physical and psychological pain. the overall prevalence of nurses working in pain is unknown because pain prevalence is site specific; however, back pain, a commonly cited source of pain, occurs in % to % of nurses. study design: a cross-sectional survey of nurses recruited via social media was conducted in . survey items included participant demographics, locations and severity of pain, impact of pain on performance at work, and coping strategies. descriptive analysis was completed. population: our convenience sample consisted of direct-patient care nurses (n = , ) in the united states. our sample was predominantly female, represented by all states, and ranged in age from to years (m = years). more than half the nurses surveyed (n = , ) had to years of nursing experience. the education level of the nurses varied, but the majority had a baccalaureate degree (n = , ; . %). the majority worked in the hospital setting (n = , ; . %). results: the majority (n = , ; %) of survey participants responded that they were currently experiencing or had experienced pain in the past week. the most frequently reported locations of their pain were back, neck, shoulders, knees, and feet. the average pain level was four out of . approximately % of nurses reported more than one location of pain. participants reported managing their pain by over-the-counter medications (n = , ; . %), nonpharmacological pain management (n = , ; . %), and prescription medications (n = ; . %). additionally, over one third of nurses (n = ; %) reported using prescription drugs, marijuana, or alcohol as a strategy to cope with their pain. on average, % of nurses stated their pain impacted their work performance and % stated their pain impacted direct-patient care. conclusions: the prevalence, severity, and impact of nurse pain on performance at work highlights the importance of addressing and investigating nurse pain. workplace interventions to address nurse pain have mostly focused on back pain through lifting devices; however, nurses continue to have high levels of back pain and pain in other locations. the propensity of unhealthy coping strategies by nurses is concerning and warrants further investigation. implications for clinical practice and regulation: in the wake of the opioid epidemic, future interventions should investigate additional pain sites and encourage healthy coping strategies for nurse pain. the legalization of marijuana in many states also presents a potential new area of research and policy as many practice environments are considering how to handle healthcare provider marijuana use. state boards of nursing have long sought to minimize and address substance use disorders given nurses' access to controlled substances. unrelieved pain among nurses combined with their work demands, as well as access and knowledge of pharmaceuticals, may contribute to the higher suicide rate of nurses by gender than their u.s. population counterparts, which is more often carried out by pharmaceutical overdose. as the nursing workforce ages, interventions to reduce nurse pain are key to sustaining the workforce. authors: peter griffiths, phd, rn, and safer nursing care tool study group: jane ball, phd; rosemary chable, msc, rn; andrew dimech, msc, rn; yvonne jeffrey; rn; jeremy jones, phd; natalie pattison, phd, rn; alejandra recio saucedo, phd; christina saville, phd; nicola sinden, msc, rn; thomas monks, phd objective: the objective of this study was to model the consequences and costs of using a recommended staffing tool (the safer nursing care tool) to guide hiring, scheduling, and deployment decisions in english acute hospitals, specifically exploring how different baseline staffing levels affect costs, the likelihood of critical staffing shortfalls, and mortality risk. study design: we compared flexible baseline staff schedules (set to meet % of the mean demand) with staffing schedules set to meet mean demand (the standard approach) and schedules set to match peaks in demand ( th percentile). in all cases, floating from units with low demand to units with high demand and temporary hires were used to provide a flexible response when demand exceeded scheduled supply on any unit on any shift. data from a multicenter observational study of staffing and patient acuity/ dependency ( , unit × days of observations over year) to provide parameters, including probability distributions for varying demands for nursing care, were used. a computer simulation was developed to model the effects of different baseline schedules and approaches to floating and use of temporary hires and over-time. the model was used to simulate daily staffing costs and the occurrence of critical (> %) understaffing. it included realistic assumptions about the possibility of scheduled staff failing to show for work at short notice due to sickness and for constraints on the availability of temporary hires and overtime. the effects of any consequent short staffing, in terms of mortality risk and length of stay, were estimated using parameters from a recent longitudinal observational study in one of the participating hospitals. an economic model estimated the cost per life saved. population: general medical surgical wards in four public hospitals in england. results: in simulation experiments, "flexible (low)" schedules led to high rates of understaffing and adverse outcomes, even when temporary staff were readily available. "high" staffing baseline schedules were associated with reductions in understaffing and improved outcomes but higher costs. under most assumptions, the cost per life saved from moving from a lower to a higher baseline schedule was below £ , (approximately $ , usd). if unlimited availability of temporary staff is assumed, the harm associated with low staff schedules was minimized, but net cost per life saved for higher staffing levels was also low: £ ($ , usd) for standard vs low and £ ($ , usd) for high versus standard. conclusions: cost savings from a policy of flexible staffing with low baseline schedules are largely achieved by below-adequate staffing. cost savings are eroded with the high temporary staff availability required to make such policies function safely. higher baseline schedules are cost-effective. implications for clinical practice and regulation: in the face of nursing shortages, which are endemic in england and many other jurisdictions, these findings illustrate the possible consequences of short staffing and illustrate that higher nursing staff levels remain a desirable goal even if staff redeployment and use of temporary staff can be used to fill gaps in rosters. the common basis of staffing tools, where mean averages are used to guide staffing decisions, is questioned. objective: home-visiting prevention programs must coordinate with other community providers to be most effective. however, the associations between collaboration and program outcomes are not well understood. nurse-family partnership (nfp) is an evidence-based prenatal and early infancy home-visitation program delivered by nurses to low-income, first-time mothers. nfp is implemented by more than agencies across the united states by public health departments, community-based organizations, and healthcare systems. this study aimed to examine the associations between cross-sector collaboration nfp and client-level outcomes. study design: we used survey data with nfp supervisors that assessed agency-level collaboration, as measured by relational coordination and structural integration with nine community provider types (including obstetrics care, substance use treatment, and child welfare). we paired the collaboration survey data with nfp program implementation data from to (n = , ) to examine outcomes including client retention, client smoking cessation, and childhood injury. we used random-intercept models with nurse-level random effects, controlling for client-level demographics and health, nurse-level demographics, and agency-level administrative and geographic factors. population: sample nfp clients were on average years old and predominately single. of sample clients, . % were white, % were african american, % identified as hispanic, . % reported another race, and % declined reporting. results: consistent with past research, we found unmarried women, african-american women, and those visited by nurses who ceased employment with nfp prior to the client's child's birth were more likely to drop out of the nfp program, whereas older women and high school graduates were more likely to remain in nfp. greater relational coordination with substance use treatment providers (or = . ; p < . ) and stronger structural integration with child protective services (cps) (or = . , p < . ) were associated with improved client retention at birth, even after adjusting for multilevel factors. structural integration with cps remains significantly associated with client retention at -months postpartum. stronger nurse coordination with the special supplemental nutrition program for women, infants, and children (wic) (or = . , p < . ) as well as with substance use treatment providers (or = . , p < . ) were associated with increased self-reported prenatal smoking cessation. stronger nurse coordination with wic (or = . , p < . ) and greater integration with mental health providers (or = . , p < . ) were associated with decreased probability of self-reported emergency department use for childhood injury. conclusions: improving healthcare through relationships with other care providers is necessary to enhance the experience and outcomes of patients, particularly among high-need complex populations. this study provides early results suggesting cross-sector collaboration in a home-visiting setting that bridges healthcare and addresses social determinants of health has potential to improve the retention of clients. more research is needed to understand how collaboration may improve maternal-reported behaviors like smoking cessation and emergency department use for childhood injury. implications for clinical practice and regulation: our findings inform efforts to increase efficient delivery of prevention programs like nfp through intentional collaboration with cross-sectors, as well as for future agency development for nfp expansion, especially as the program moves toward integration with healthcare delivery systems. authors: allison norful, phd, rn, anp-bc; yun he, bm; adam rosenfeld, ba; cilgy abraham, bs, rn objective: primary care providers (pcps) are increasingly reporting burnout when trying to meet demands for patient care. previous evidence suggests that individual pcps require hours per day to complete all care responsibilities. policymakers are calling for novel delivery models to help meet the care demand. one emerging model, provider co-management, has been shown to yield optimal clinical outcomes. co-management is structured with two pcps, often interdisciplinary dyads (e.g., physicians and nurse practitioners), who share care responsibilities for the same patient. theoretically, co-management is comprised of dimensions: effective communication, mutual respect/trust, and shared philosophy of care. it remains unclear, however, whether co-management alleviates pcp burnout. thus, the purpose of this study was to determine the impact of co-management on pcp burnout and job satisfaction. study design: we conducted a cross-sectional survey of pcps in new york state using dillman methodology. paper surveys were mailed to a listserv of randomly selected pcps obtained from iqvia, the largest provider reference database in the united states. postcard reminders were sent after weeks and then a second survey was sent to nonrespondents. the provider co-management index (pcmi) (r = . ) was used to measure comanagement with higher scores, indicating more effective co-management. the maslach burnout inventory (r = . ) was used to scale self-reported burnout. we calculated descriptive statistics and crude odds ratios from bivariate logistic regression models. next, adjusted odds ratios were calculated from multivariable logistic models controlling for provider and practice characteristics. population: our sample included pcps across new york state, made up of physicians (n = ), nurse practitioners (n = ), and physician assistants (n = ). half of participants worked in provider-owned practices ( %) and had more than years of experience ( %). results: almost % of pcps reported job dissatisfaction and burnout. there were no significant differences in responses between workforce types. pcps who reported burnout had % less odds of job satisfaction (or = . , % ci = . , . ). similarly, participants who reported burnout had more than three times the odds of planning to leave their position in the next year compared to those who did not report burnout (or = . , % ci = . , . ). with each unit increase in total pcmi score, there was . times the odds of job satisfaction (or = . , % ci = . , . ). the magnitude of effect became larger when looking at pcmi subscales representing each co-management dimension. each unit increase in one pcmi subscale was associated with % less odds of burnout and % less odds of intention to leave a position within year. estimates in adjusted models holding controls constant remained similar to those in the unadjusted models. conclusions: the more effective that co-management is between pcps, the less significantly associated are provider burnout, job dissatisfaction, and intent to leave current position. provider comanagement may be a promising approach to help alleviate pcp burnout. implications for clinical practice and regulation: attention to interdisciplinary team compositions and policies that enable comanagement care delivery dimensions are recommended to help alleviate burnout. further research, including comparative and cost-effectiveness studies, are warranted to determine financial sustainability of organizations that implement co-management models. the increasing volume of registered nurses (rns) employed in primary care settings may offer solutions to overcoming care delivery complexities facing international healthcare systems, including canada. there is growing evidence that rns in primary care improve access, reduce costs, and promote higher quality care; however, there is a lack of clarity surrounding the effective deployment of the rn role, specifically in primary care settings. the purpose of this study was to develop and validate a set of national primary care rn competencies in canada. the competencies aim to better support the integration and optimization of the role of rns in primary care. study design: this study employed a delphi survey process. an initial draft of competencies consisting of statements was created and guided by international literature, a panel of key informants (i.e., researchers, stakeholders, project partners), and competencies of related practice areas, such as public health nursing and home care. using an online survey platform, participants rated the importance of each competency statement using a -point likert scale ( = not important; = extremely important) and offered written feedback/suggestions. statements that did not reach consensus (≥ % agreement or mean ≥ . ) were modified and sent to participants for a second (final) delphi round. population: canadian nurses with knowledge and expertise in primary care were identified through snowball sampling, online searches, and professional organizations (e.g., canadian family practice nurses association) and invited to participate in the survey through email correspondence (n = ). individuals represented all domains of nursing (i.e., clinical, research, education, policy, administrators) and all canadian provinces and territories. the survey was available in both english and french. results: the first survey was completed by % ( / ) of invited participants (april and may ), and % ( / ) of these firstround participants completed the second follow-up survey (june through august ). most competencies (n = ) achieved agreement after the first survey (m = . , sd = . ); one statement was dropped and two were combined following the second round. the finalized competency list consisted of distinct statements organized across domains (professionalism; clinical practice; communication; collaboration and partnership; quality assurance, evaluation, and research; leadership). conclusions: a concise and preliminarily validated set of primary care rn competencies was developed. these competencies may be used to guide nursing curricula, increase understanding of the primary care rn role, improve interprofessional team functioning, and are foundational to strengthening the rn workforce in primary care. implications for clinical practice and regulation: primary care rn competencies have tremendous value to relevant stakeholders, including international policymakers, to use as a framework to inform administrators, clinicians, and researchers for targeted integration and optimization of rns within primary care. in addition, the competencies can help inform local, provincial, and national policies, including funding models. currently, the canadian nurses association plans to incorporate these competencies into the community health nursing certification examination. next steps involve conducting two cross-sectional surveys with academic deans/directors and front-line primary care rns to assess the integration of competencies within canadian nursing curricula and the performance/learning needs of rns in primary care relative to these competencies. future research will validate such competencies in other countries. americans with the goal of modifying behavior, one must be particularly sensitive to building trust and to the preferences and choices of the clients. community-based participatory research (cbpr) builds a foundation of trust between investigators and participants by eliciting contributions from community members into the research process. the purpose of this study was to apply the cbpr framework to engage the african american faith-based community in the development of a health education program to address hypertension using both group learning and activities based in virtual reality (vr). study design: applying a cbpr framework, an expert panel consisting of members of a faith-based community along with the council of black nurses (los angeles chapter) was assembled and co-led by the community pastor and the research team from a medical center that serves this community. two modified delphi exercises elicited input regarding food preferences for the vr, and a -minute focus group gathered input on health, exercise, and stress management. the focus group transcript was analyzed using content analysis methodology and the results were used to develop the course content. population: fifty-eight participants aged to years were recruited from a predominately african american church in los angeles, california, where all research activities were held. results: with participant input, the vr intervention included education on adverse impacts of high sodium diets on blood pressure (bp) and body organs, culturally common low-sodium food alternatives, and stress management meditation and mindfulness exercises (recorded by the pastor). group preference identified content for a -session course that included (a) diet and sodium intake, (b) bp monitoring, (c) healthy lifestyle, (d) exercise, (e) diabetes, (f) sleep and stress management, (g) genetics and health, (h) a cooking class, and (i) tai chi. initial interest and participation were so high that study recruitment targets were expanded. participant feedback was collected during classes. feedback on the course was positive. despite having technical support, participants found the vr component to be challenging; thus, vr use was suboptimal. conclusions: although there were several challenges associated with implementation of the vr component of the intervention with this cohort, lessons learned provide insight on how to incorporate community input into the development of technologies meant to support hypertension control in vulnerable populations. the cbpr approach was used to successfully partner with a faithbased community to develop interventions aimed at health promotion and disease prevention. implications for clinical practice and regulation: churches are excellent venues for delivery of community-based lifestyle interventions because of their pre-existing social networks, consistent attendance, and a faith-based focus in enhancing the connection between mind, body, and spirit. ideally, the impetus for changing behavior should come from within the targeted community itself, and the intervention should be built around the preferences and choices of that community. cbpr involving community stakeholders provides the foundation for collaborations that are responsive to the specific needs of a community and can improve understanding of the underlying contributors of persistent health disparities. authors: jane bolin, jodie gary, cynthia weston, nancy downing, allison pittman, cherrie pullium objective: the goal of this mixed methods study was to conduct both quantitative and qualitative research with dissemination to community partners toward forming a united regional consortium focused on increasing access to opioid use disorder (oud) prevention, treatment, and recovery, ultimately improving the health and wellbeing of children and families. an overarching goal is to address challenges of delivering care in underserved and rural communities. design: we employed mixed methods to examine longitudinal trends of opioid-related admissions in the rural gulf bend region over a -year period. we then conducted several weeks' worth of focus groups and structured interviews in each of the counties. we utilized a semi-structured interview guide to engage the community in identifying the scope of oud and its impact on children, including neonates. focus groups explored gaps in available treatment and recovery services and in critical resources and workforce. the project was designated non-human subjects research by the texas a&m institutional review board. population/sample: our study was conducted in seven counties in the rural gulf bend region of texas that are impacted by rising rates of opioid misuse and exacerbated by co-occurring use of other narcotic, controlled substances, as well as alcohol. children and their safety were a focus of our study. findings: fifteen focus group interviews with over stakeholders included physicians, nurses, hospital administrators, advocacy groups, treatment centers, child protective services, first responders, law enforcement, social workers, faith-based groups, and elected officials. the outcome was an oud community assessment of existing prevention, treatment, and recovery resources and access to resources; assets and opportunities; and gaps and constraints. strategies identified included targeted oud education and training, access to medication-assisted treatment and peer-topeer recovery support, and access to mental health resources. use of innovative telehealth programs are planned to address gaps in services. conclusion: oud is a significant health and safety issue for children and their families. neonates are born addicted and families are impacted, as are hospitals, schools, and law enforcement. implications include collaborative partnership development and gathering a community voice to address gaps in prevention, treatment, recovery, and workforce. community-driven solutions were identified to build capacity through existing community strengths and shared knowledge and communication of resources. innovative strategies include the use of peer-to-peer parent recovery support and nurse-led telehealth programs. implications: our research demonstrated that community stakeholders believe that oud is contributing to child neglect and abuse and contributes to economic insecurity, which severely impacts children. infants born to mothers with oud are at risk for neonatal abstinence syndrome. parental oud can also lead to separation from children due to incarceration, treatment, hospitalization, or child removal. child removal is traumatic, and foster care placement may contribute to adverse mental and physical health outcomes for children. adverse childhood experiences related to parental substance abuse or separation are associated with developmental disruption, risk behaviors, adverse physical and mental health conditions, and increased healthcare utilization. funding: health resources and services administration rural community opioid response planning grant; awarded june to jane bolin, primary investigator. authors: jane bolin, nancy fahrenwald, cindy weston, and debra matthews objective: this study addresses two national problems. first, in the united states, especially in texas, healthcare suffers from a severe shortage of nurses. second, there are more than , nurses, including advanced practice nurses, nationally who have run afoul of the law and thereby lost their license and privilege to practice their professions. the central goals and aims of this research were to examine the oig's fraud and abuse list of sanctioned healthcare providers (publicly available) and to analyze the characteristics of nurses who have lost their license or have been barred from participating in medicare and medicaid. design: we employed mixed methods to explore what interventions may be effective for rehabilitating sanctioned nurses and learn from these individuals what factors influenced them to choose crime or deviant behavior after investing so much time, energy, and financial resources in their professional training. in future studies, we will explore what measures, requirements, and restraints should be put in place for rehabilitation of those who were once licensed healthcare providers in good standing, including surveying state licensing boards. population/sample: nurses, including nurse practitioners and doctors of nursing practice, who have been convicted of behavior leading to their exclusion from practice in the united states. as of january , more than , nurses are listed in the office of the inspector general's (oig's) list of sanctioned and excluded providers. findings: currently, more than , nurses have been convicted or sanctioned for prohibited conduct leading to their exclusion from practicing in programs that are eligible for medicare and medicaid payment. twenty-seven nps have been excluded/ convicted, nursing firms, and , individuals designed as nurses. california and texas lead the nation in excluded nurses at , and , , respectively. tragically, , nurses have been convicted of patient abuse, have been convicted of healthcare fraud, and , have had their licenses revoked by their state boards. conclusion: shortages of nurses are especially severe in rural and underserved parts of texas and the united states. rural citizens are often to hours from the closest healthcare provider. as a profession, we need to explore whether it is possible to address the nation's severe health care provider shortage by redeeming nurses who lost their license through financial fraud or other unlawful behavior. programs for rehabilitating nurses and subject to appropriate oversight and restriction may address the current severe provider shortage in medically underserved areas. implications: the potential of such a program is enormous and paradigm changing. however, we must first identify those who can be successfully rehabilitated. researchers in this multi-phase study will next explore what interventions may be effective for rehabilitating sanctioned providers to determine what factors influenced them to choose crime or deviant behavior. it is imperative that we explore what measures should be put in place for rehabilitation of those who were once licensed in good standing. we will also survey experts from state licensing boards to determine what approaches might be employed to rehabilitate even a fraction of the more than , + sanctioned nurses sitting idle on the sidelines. funding: the president's excellence fund, triad- initiative, , provided support for this research. author: jacqueline nikpour objective: in a healthcare system rapidly shifting from rewarding volume to incentivizing value, policymakers, payers, and health systems are increasingly focused on addressing patients' "upstream" social determinants of health (sdoh). typically, medicaid funds cannot be used for nonmedical interventions, but north carolina has received permission from the centers for medicare and medicaid services, through an waiver, to use medicaid funds for "healthy opportunity pilots" that address the sdoh. due to nurses' education, broad scope of practice, and focus on holistic, whole-person care, the workforce is uniquely positioned to address housing instability, food insecurity, and other population health issues. yet little evidence exists describing the supply, distribution, education, and practice characteristics of the nursing workforce available to address these challenges. this information is critical to identify where nursing workforce gaps exist that may jeopardize an effective rollout of north carolina's healthy opportunity pilots. design: this study used north carolina licensure data to describe the demographic, education, and geographic characteristics of the nursing workforce in the following sdoh settings: ambulatory care, public/community health, occupational health, long-term care, home health, correctional facilities, and schoolbased health. we compared these "population health" nurses to those employed in hospital settings using chi-square and t tests. north carolina's counties and medicaid regions were used as the units of analyses for measures of supply and population health need. we categorized medicaid regions as high income, moderate income, and low income based on their th percentile income level and performed one-way anova tests to determine differences in nurse supply. we then merged licensure data, at the county level, with the county health rankings to compare the distribution of population health nurses with population health needs using spearman correlation analyses. population/sample: , rns in active practice in north carolina in . findings: in , nearly % of nurses were practicing in a population health setting, compared with % employed in hospitals. compared to hospital nurses, population health nurses were more likely to be female ( . % vs. . %, p < . ) and less likely to have a bachelor's degree or higher ( . % vs. . %, p < . ). there was no difference in nurse race between hospitals and population health settings (p = . ). one-way anova tests revealed that population health nurses were significantly more likely to work in high-income regions when compared with moderateincome and low-income regions (f = . , p = . ), potentially due to the fact that . % of the state population is located in these two counties. at the county level, a lower supply of population health nurses was associated with higher rates of uninsured people (p = . ), unemployment (p < . ), child poverty (p < . ), low income (p < . ), poor or fair health (p = . ), physically unhealthy days (p = . ), mentally unhealthy days (p = . ), air pollution (p < . ), and preventable hospitalizations (p = . ). conclusion: north carolina's population health nurse workforce is not well distributed relative to the state's population with higher sdoh needs. implications: as north carolina prepares to implement its health pilots, workforce planning initiatives are needed to more equitably distribute the supply of population health nurses across the state. authors: shirley girouard, phd, rn, faan; michele solloway, phd, mpa objective: a state government and an urban university collaborative project seeks to understand and promote knowledge about food insecurity (fi) among older adults. we sought to develop tools to assess and increase fi screening and referrals as well as increase access to nutrition education and food resources with the ultimate goal of reducing fi-related health disparities. population/sample: adults aged or older in a large, diverse urban community with high health disparities. findings: a total of surveys were collected from participants at health fairs and community presentations. the mean age of respondents was . years. the majority were women ( %). more than half were black ( %), % were caribbean, and % were mixed or "other." approximately % were at high fi risk and % at moderate fi risk. approximately % of respondents received food stamps. among respondents with health conditions (n = ), more than half had high blood pressure ( %) or high cholesterol ( %); %, diabetes; %, heart disease; and %, stroke. three-quarters ( %) had or more conditions; %, or more; and %, or more. notably, % of respondents had all conditions listed. almost in respondents indicated that obtaining healthy and sufficient food was hampered by health conditions ( %) or mobility ( %). conclusion: fi was documented as a significant problem and compounded in complexity for individuals with multiple medical conditions. fi is also interwoven with culture and literacy. discerning levels of fi risk for triage and policy purposes appears viable. phase i of the project was well received by all key stakeholders; therefore, phase ii was initiated. additional support is sought to continue phase i activities and develop a primary care assessment, referral, and follow-up model. implications: developing a screening tool to differentiate levels of fi risk is necessary to develop tailored community-based interventions for specific communities. data generated by the survey facilitates health professions student education as well as ongoing education for providers. cultural, literacy, mobility, access, and health disparity issues associated with fi risk become addressed more consistently as a result. identifying high fi patients in practice can also lead to improved triage and referral by differentiating patients who require more intensive individual counseling from those who could benefit from community resources and classes. such policies, programs, and practices can improve healthy eating and thus improve health outcomes for older adults. the national institute on minority health and health disparities research framework health disparities and health equity: concepts and measurement systems change for the social determinants of health year of the nurse and objective: nurses are instrumental in preventing adverse events through the delivery of high quality, safe patient care in an efficient and effective healthcare system. however, workplace bullying may undermine safety culture in the workplace, subsequently affecting nursing care and patient outcomes. the objective of this study was to explore the association between the nursing work environment and nurse-reported workplace bullying and the association between nurse-reported workplace bullying and patient outcomes, including nurse-reported quality of care and nursereported patient safety grade. design: we conducted a cross-sectional analysis using data obtained from the alabama hospital staff nurse study. the nursing work environment was measured using the original practice environment scale of the nursing work index (pes-nwi) with five domains represented as subscales and a composite score. nurse-reported workplace bullying status was identified as "yes" or "no" using the short negative acts questionnaire (snaq) through a latent class analysis. nurse-reported quality of care and patient safety grade were measured using single-item measures. the responses were dichotomized into either "excellent/good" or "fair/poor" for quality of care, and either "favorable" or "unfavorable" for patient safety grade. random effects logistic regressions were used to determine associations controlling for individual and employment characteristics. odds ratios (ors) and % confidence intervals (cis) were obtained to examine the strength of associations. all statistical analyses were conducted using r version . . . population/sample: inpatient staff nurses working throughout alabama (n = ). findings: nurses in this study were predominately white ( . %) and female ( . %). the median age was years. most nurses held a bachelor's degree ( . %), had primarily worked as a nurse for a median of years, and were full-time ( %), permanent ( . %) employees working -hour ( . %) day shifts ( . %) with minimal overtime ( hours per week). a total of ( %) nurses reported experiencing workplace bullying. nurses primarily reported excellent/good quality of care ( . %) and a favorable patient safety grade ( . %). after controlling for individual and employment characteristics, a higher pes-nwi composite score was significantly associated with a lower risk of nurse-reported workplace bullying (or = . , % ci = . , . , p < . ). nurses experiencing workplace bullying were less likely to report good/excellent quality of care (or = . , % ci = . , . , p < . ) or a favorable patient safety grade (or = . , % ci = . , . , p < . ). however, these patient outcome associations were mediated by the pes-nwi composite score (or = . , % ci = . , . , and or = . , % ci = . , . , p = . , respectively). conclusion: these findings suggest that improving the nursing work environment can potentially decrease nurse-reported workplace bullying and perhaps subsequently improve patient outcomes. implications: the nursing work environment consists of modifiable, organizational factors that either support or detract from a nurse's ability to provide safe, high-quality patient care. further exploring specific aspects of nursing work environments using the pes-nwi can inform the development of targeted organizationallevel anti-bullying interventions. such interventions, however, must include the improvement of the nursing work environment. key: cord- -o xsmg z authors: kuznetsova, lidia title: covid- : the world community expects the world health organization to play a stronger leadership and coordination role in pandemics control date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: o xsmg z the coronavirus disease (covid- ) pandemic has been accompanied by the return of the concept of national state and exhibited signs of crisis of globalism and liberalism. the pandemic affected most aspects of society and human activity, including socioeconomic impact. economic problems, shortages of medical supplies and personnel, xenophobic sentiments, and misinformation led to the use of unethical practices and human rights violations. to navigate through this crisis, many countries resorted to traditional diplomacy in the absence of effective international instruments. thus, the world faced the urgent need in functioning global governance. the pandemic also manifested the increasing importance of international organizations as sources of technical expertise, providing scientific basis for politicians to legitimize their decisions and actions. the article addresses the topic of implications of the pandemic for governance and forecasting a post-pandemic future. the research focus of this paper, therefore, is the assessment of the role of the world health organization (who) in prevention and response to pandemics. the work is aimed at identifying the functions of the who and assessing its activities in prevention and control of pandemics and response to the covid- pandemic in particular. furthermore, the objective of this article is to identify gaps in the who pandemic control efforts and formulate recommendations on addressing them. the coronavirus disease (covid- ) pandemic and other recent and ongoing infectious disease outbreaks, emerging, re-emerging, and neglected infectious diseases, as well as bioterrorism, posing a threat to health security, suggest the necessity and significance of pandemics-related research. the control of pandemics is impossible without international cooperation, due to their transboundary nature, and intergovernmental organizations are to play an important role in pandemic preparedness and response. the world health organization (who) is the only source of legally binding international regulations for pandemic response, the importance of which is growing, and a provider of technical assistance and standard guidelines to the states ( ) . strong national health systems are the foundation for effective pandemics prevention and control, and their strengthening is crucial, especially in low-income countries. the international system of mechanisms of response to pandemics is currently in the process of formation, and it is a dynamic process. the challenge for such system is to ensure the existence of supranational legal authority and make it function. the authority and the capacity of the who to lead the international response have been questioned during the ebola outbreak and the covid- pandemic. the crises also revealed the lack of resources of the who to effectively prevent and respond to pandemics ( ) . at the same time, the role of emerging influential and resourceful actors in pandemic control has been growing, including the world bank group, the bill and melinda gates foundation, médecins sans frontières, and other organizations. one of the central issues in international efforts to prevent and control pandemics is the aid to the poorest countries to develop health systems and ensure availability and accessibility to the basic health services by their population ( ). the role of international mechanisms advanced significantly from adopting the who international health regulations (ihr) in , focusing on just three diseases (cholera, plague, and yellow fever), to approving the current version of the ihr in and to creating the who contingency fund for emergencies (cfe) in ( , ) . during the sars outbreak in , the problem of coordinating response actions in different countries already became obvious. the existing response mechanisms were rather slow and disorganized. the outbreak revealed the necessity to modify the ihr. the revision of the ihr in allowed the who to declare public health emergency of international concern (pheic) and required the member states to strengthen national emergency response capacity. the revised version of the ihr was tested by h n influenza outbreak in , when weaknesses in the global response to influenza pandemic were revealed again. the who issued recommendations to the member states to create more extensive reserve global health workforce and establish $ million contingency fund for future pandemics. however, these recommendations were not implemented until ( ) . the ebola crisis revealed the importance of legal instruments and raised legal and ethical issues, due to, for example, introduction by some governments of trade and travel restrictions. this outbreak questioned the who credibility and the effectiveness of the ihr ( ). the who plays a key role among all intergovernmental organizations involved in tackling pandemics, and it is the only source of legal authority. the core functions of the who related to pandemics prevention and control include the following: support member states in developing national capacity to respond to pandemics, support training programs, coordinate member states for pandemic and seasonal influenza preparedness and response, develop guidelines, and strengthen biosafety and biosecurity ( ) . the main instruments used by the who for pandemic prevention and control include the ihr, the global outbreak alert and response network (goarn), the public health emergency operations centre network (eoc-net), the contingency fund for emergencies, and the pandemic influenza preparedness (pip) framework. at the strategic level in pandemic control, the who focuses on reinforcing national public health systems, one health approach, and strengthening global partnership. the ihr is a legally binding regime for protection and management of disease threats. it is a framework for collective response to the threats, involving one or more countries, or to public health events of global significance. the current version of the ihr entered into force on june , and they are binding on countries across the globe, including all who member states ( ). to date, the progress has been achieved in some areas of the ihr implementation, for example, introduction of national focal points to connect with different government sectors, stakeholders, and the who; increased transparency in reporting; improved use of early warning systems; and enhanced cooperation between organizations dealing with human and animal health. nevertheless, there are still significant gaps related to the ihr. by the original deadline of june , only onefifth of the who member states had met the core capacity requirements, and by , one-third ( ) . the problems related to the ihr implementation are lack of resources and difficulties in developing effective public health services. the ihr are not flexible enough to be adapted to local conditions. the criteria and mechanisms for declaring public health emergencies and for complying with the ihr need to be improved. the procedures should be simplified for the countries with scarce resources ( , ) . in order to provide rapid access to resources and expertise for effective response to public health emergencies, in , the who and partners established goarn. the network provides a global operational framework encompassing a wide range of capacities and expertise, and it is aimed at coordinating support to countries and effectively deploying response teams. goarn links over institutions and networks and includes over partners around the world ( ) . since its establishing, the network has been involved in field missions in countries, deploying over professionals to the field ( ) . goarn is considered to be effective, and it has gained trust and respect. the who stresses the importance of training and maintaining a reserve global health emergency personnel ( ) . goarn focuses on the technical support roles and improving surveillance. despite its efficiency, during ebola outbreak, it became clear that goarn needs to strengthen its leadership, respond faster, and broaden its capacity ( ) . in , the who established eoc-net to identify and disseminate best practices and standards for eocs and support eocs' capacity building in member states. the who works with eoc-net partners to develop evidence-based guidance for establishing, operating, and improving eocs ( ) . considering the criticism of the who in terms of lack of resources and slow response to emergency situations, cfe was established by the world health assembly in , with the target funding of us$ million for the / biennium. this target has been achieved. since the establishment of cfe, the member states have contributed over us$ million to it ( ) . the distinctive feature of this fund is that it can be mobilized within h, while the other financing mechanisms have different funding criteria and slower disbursement cycles. for this fund to be effective, it needs to attract greater levels of multi-year flexible financing ( ) . pip framework for the sharing of influenza viruses and access to vaccines and other benefits is an international agreement adopted by the world health assembly in to improve global pandemic influenza preparedness and response. the framework includes a pip benefit sharing system that foresees an annual partnership contribution to the who from influenza vaccine, diagnostic, and pharmaceutical manufacturers through the who global influenza surveillance and response system ( ) . through this mechanism, the who will ensure the immediate availability of necessary products in case of influenza pandemic. furthermore, who partners have contributed us$ million to improve pandemic influenza preparedness and response. according to gostin et al. ( ) , even though pip framework is not a treaty, it has features of international law, such as collective accountabilities, partners collaboration, and compliance procedures. global partnership is one of the main areas of work to guide the ihr implementation. key partners to support the who implementation include the food and agriculture organization, the world organization for animal health, the un children's fund, the international labour organization, the european union (eu), international aid agencies, who collaborating centers, and non-governmental organizations and foundations ( ) . according to the provisions of the ihr, on january , the who declared the outbreak a pheic and assessed the risk as very high for china, and high at the global level. on march, the who said that the outbreak can be characterized as a pandemic ( ) . the who did not recommend limiting trade and movement, in line with ihrs. many countries, however, have not followed these recommendations ( ) . shortly after announcing the pandemic, the who launched the covid- solidarity response fund. this initiative allows individuals and organizations around the world to directly support the work of who and partners to help countries with greatest needs prevent, detect, and respond to the covid- pandemic. the disbursement mechanism for money raised through the fund is quick and flexible. as of july , the solidarity response fund collected more than million usd from more than , individuals and organizations ( ) . furthermore, the who has also been involved in other fundraising efforts, such as establishing the who foundation and organizing charity concerts. another key initiative to respond to drastic medical supply shortages and potential food crisis in a number of countries, the who in collaboration with the world food program established the un covid- supply task force in april , within the framework of covid- supply chain system. this mechanism has been created to coordinate the procurement of medical supplies to countries with overwhelmed health systems. this initiative will be run by the who and the world food program, together with a number of un partners. the supply chain hubs will be located in belgium, china, ethiopia, ghana, malaysia, panama, south africa, and the united arab emirates. according to the who, the supply chain may need to cover more than % of the world's needs in the acute phase of the pandemic ( , ) . prior to launching this mechanism, the who has already shipped personal protective equipment and diagnostic tests to over countries. the who has also launched a "solidarity trial" initiative, an international clinical trial, with the participation of countries, aimed at finding effective treatment through rapidly discovering whether any existing drugs can slow the progression of the disease, or improve survival ( ) . in collaboration with partners, the who launched a global collaboration to accelerate the development, production, and equitable access to new covid- diagnostics, therapeutics, and vaccines ( ) . the who has been extensively involved in providing training and technical assistance thought its openwho platform and goarn knowledge hub and in deploying experts via goarn network ( ) . the who tackles misinformation through carrying out various online campaigns and being active on all social media channels. it releases daily situation reports and holds press conferences for updating the media about the pandemic. in march , the who has started allocating the funds from cfe by releasing $ million to the most vulnerable countries ( ) . the response initiatives by the who have come under criticism, mainly by the us president donald trump, who accused the who for failure to control the pandemic and for promoting the interests of china. in april , d. trump announced the suspension of the us financing of the who and later on the withdrawal of the us membership in the who. however, other members such as china, france, and germany pledged extra funding to the who to compensate for the lack of resources ( , ) . thus, the who has been engaged in political confrontation, which has led to changes in balance and redistribution of influence among the member states. covid- and previous pandemics have tested the leadership of the who and revealed a number of problems in its activities. the who response to both the influenza pandemic and the covid- pandemic has been extensively criticized. the main points related to the who pandemic prevention and control activities that have come under criticism are as follows: . over/underestimation of threat. . conflict of interest and political bias. . problems related to the ihr implementation. . slow response. . lack of financial resources. . the who is seen as a more political and less technical organization ( ). . the who pandemic preparedness plans are ill-equipped to foresee and solve unique ethical challenges that may arise during different infectious disease outbreaks ( ) . apparently, the allegations of overestimation of threat and accusations of conflict of interest following the influenza pandemic have led the who to be more cautious in its statements and in declaring pheic and pandemic. the who followed experts' advice to mobilize the wider national, regional, and international community at earlier stages of an outbreak prior to a declaration of a pheic ( ). the majority of countries do not meet the core capacity requirements for the implementation of the ihr ( ). a number of provisions the ihr have been violated by countries during the covid- pandemic, as it had already happened during the ebola pandemic ( ) . there is no multilateral strategy or funding to address the problem of pandemic preparedness and developing capacities for implementation of the ihr in lowincome countries ( ) . at the same time, progress has been achieved in such areas as surveillance and communication among stakeholders involved in pandemics control and organizations dealing with human and animal health. some experts argue that the ihr do not create international law that is binding on the participant countries, due to the implementation and compliance problems. in practice, the international community applies "soft law" that implies nonbinding duty to collaborate with other countries and with the who with regard to infectious disease surveillance and control of outbreaks. although such "soft law" is neither mandatory nor enforceable, it is powerful politically. the reasons for why this "law" is functioning are that contributing to and enhancing international collaboration in infectious disease response is in a country's self-interest and that the who managed to create a framework for international cooperation on infectious diseases that is able to withstand the increasing global threats posed by pathogens ( ) . suthar et al. ( ) consider sanctions and embargoes a viable alternative to the functioning ihr. while using such measures can be inevitable in certain situations, as practice shows, these instruments can be based on the principle of double standard and be used for political manipulation purposes. the who has been working on adjusting its policies and activities according to identified gaps, for example, by establishing the cfe. experts point out evident progress in the who response to the ebola outbreak in congo in , compared to its response to the outbreak ( ) . during the covid- pandemic, the role of the who as a source of information and knowledge dissemination organization turned out to be critical, due to uncertain rapidly evolving situation and a lack of data and scientific knowledge about the virus and the disease. given the significant impact of misinformation on countries' pandemic control efforts, this function of the who is especially important in the countries with low trust in government. the who pays special attention to developing collaboration with other organizations involved in pandemics preparedness, focusing on one health approach. during the covid- pandemic, the who has been collaborating and coordinating response with a wide range of international organizations, including the world bank group, various un agencies, gavi, the global fund, the eu, etc. ( ) . the recommendations to improve the who capacity to prevent and control pandemics are as follows: . continue the ongoing reform of the who. . member states should ensure stable financing for the organization. . the who should work on increasing its credibility, paying special attention to ensuring the organization's transparency, political and business neutrality, and adapting evidence-based decisions and policies. . the member states should develop political trust, and the organization should be unbiased, distance itself from politics, and focus on its technical functions. . focus the international efforts to tackle pandemics on longterm development aid programs and projects. . concentrate efforts on developing basic health infrastructure and strengthen health systems in countries most vulnerable to pandemics. . further consider the options for the ihr enforcement mechanism and the ihr revision. . create a coordinated, adequately funded global health initiative to deliver assistance to the vulnerable countries to build their capacities to implement the ihr. . the who should further collaborate with partners to resolve the issues, indirectly related to the who functions, that impede effective prevention and control of pandemics. the most vulnerable countries to pandemics are conflict-affected countries ( ) . therefore, a powerful instrument to prevent pandemics is the prevention of conflict escalation. the aid efforts, including the efforts to strengthen health systems, will be ineffective and inefficient as long as the governments are involved in conflicts in the pursuit of taking over natural resources and boosting the profits of military corporations. furthermore, the countries-beneficiaries of development aid can critically perceive the contradiction between the negative effects of economic policies dictated by the donors and development aid initiatives aimed at mitigating various effects of such policies on society and health of the population ( ) . such issues, however, do not fall under the direct responsibility of the who, and the who cannot be held accountable for these shortcomings. in response to the covid- pandemic, the who has been working in line with its core functions related to pandemic control. it has used some of the existing mechanisms for pandemic prevention and control and created new ones to respond to covid- . overall, given the situation of uncertainty and lack of knowledge about covid- , the who has taken timely appropriate steps in the initial response to the pandemic. the measures adopted by the who lie within the scope of the organization and have been limited by its mandate and available resources. lessons learned from covid- pandemic response should be further analyzed, and the organization's emergency response mechanisms and capacity should be improved, as discussed above. many experts agree on the necessity to provide the who with more resources and stable financing and extend its mandate ( , , ) . the world community expects the who to play a stronger leadership and coordination role. the original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s. world health organization. strengthening health security by implementing the international health regulations independent oversight and advisory committee for the who health emergencies programme. interim report on who's response to covid- global preparedness monitoring board. a world at risk: annual report on global preparedness for health emergencies available online at between combat boots and birkenstocks' -lessons from hiv/aids, sars, h n and ebola global health security: the wider lessons from the west african ebola virus disease epidemic strengthening national emergency preparedness thematic paper on the status of country preparedness capacities promoting public health legal preparedness for emergencies: review of current trends and their relevance in light of the ebola crisis world health organization. global outbreak alert and response network available online at strengthening response to pandemics and other public-health emergencies: report of the review committee on the functioning of the international health regulations. and on pandemic influenza (h n ) world health organization. public health emergency operations centre network world health organization. contingency fund for emergencies world health organization. enabling quick action to save lives: contingency fund for emergencies world health organization the global health law trilogy: towards a safer, healthier, and fairer world world health organization. international health regulations , areas of work for implementation. world health organization available online at world health organization. who director-general's statement on ihr emergency committee on novel coronavirus ( -ncov) world health organization. covid- solidarity response fund for who united nations. un leads bid to help countries get vital amid severe global shortages available online at: https://www. who.int/dg/speeches/detail/who-director-general-s-opening-remarks-atthe-media-briefing-on-covid world health organization access to covid- tools (act) accelerator. ( ) goarn partners deploy experts to fight the covid- pandemic world health organization. contingency fund for emergencies pledge hundreds of millions of extra funding to world health organization china to give who an extra $ m to fight coronavirus ethics for pandemics beyond influenza: ebola, drug-resistant tuberculosis, and anticipat-ing future ethical challenges in pandemic preparedness and response do not violate the international health regulations during the covid- outbreak global health security demands a strong international health regulations treaty and leadership from a highly resourced world health organization lessons learnt from implementation of the international health regulations: a systematic review timeline of who's response to covid- identifying future disease hot spots: infectious disease vulnerability index medicina preventiva y salud pública covid- reveals urgent need to strengthen the world health organization the author confirms being the sole contributor of this work and has approved it for publication. the author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.copyright © kuznetsova. this is an open-access article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- -ef i bo authors: sciberras, justine; camilleri, lara maria; cuschieri, sarah title: the burden of type diabetes pre-and during the covid- pandemic – a review date: - - journal: j diabetes metab disord doi: . /s - - - sha: doc_id: cord_uid: ef i bo introduction: diabetes mellitus is a chronic disease and a global epidemic. it is a known fact that co-morbidities, including diabetes mellitus, pose a higher risk of infection by covid- . additionally, the outcomes following infection are far worse than in people without such co-morbities. factors contributing to the development of type diabetes mellitus (t dm) have long been established, yet this disease still bestows a substantial global burden. the aim was to provide a comprehensive review of the burden of diabetes pre-covid- and the additional impact sustained by the diabetes population and healthcare systems during the covid- pandemic, while providing recommendations of how this burden can be subsided. methodology: literature searches were carried out on ‘google scholar’ and ‘pubmed’ to identify relevant articles for the scope of this review. information was also collected from reliable sources such as the world health organisation and the international diabetes federation. results: t dm presented with economic, social and health burdens prior to covid- with an significant ‘disability adjusted life years’ impact. whilst people with diabetes are more susceptible to covid- , enforcing lockdown regulations set by the public health department to reduce risk of infection brought about its own challenges to t dm management. through recommendations and adapting to new methods of management such as telehealth, these challenges and potential consequences of mismanagement are kept to a minimum whilst safeguarding the healthcare system. conclusion: by understanding the challenges and burdens faced by this population both evident pre-covid and during, targeted healthcare can be provided during the covid- pandemic. furthermore, implementation of targeted action plans and recommendations ensures the care provided is done in a safe and effective environment. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. diabetes mellitus is a chronic disease resulting from the reduction in the body's response to insulin production by the pancreas either due to an increase in insulin resistance or due to decreased insulin production [ ] . in the past three decades, incidence of diabetes has quadrupled worldwide [ ] . diabetes has also classified as the th leading cause of death globally in [ ] . according to the recent data published by the international diabetes federation, million adults ( - years) suffered from diabetes in . if not adequately controlled, the global diabetes prevalence is expected to increase by approximately % in [ ] . the contributing factors for the development of type diabetes (t dm) can be broadly divided into genetic and environmental factors. electronic supplementary material the online version of this article (https://doi.org/ . /s - - - ) contains supplementary material, which is available to authorized users. some specific risk factors include, obesity, smoking, leading a sedentary lifestyle, age and also the presence of metabolic syndrome [ , ] . the pathophysiology and the underlying risk factors have long been established, yet the incidence of diabetes is still on a progressive incline [ ] the coronavirus sars-cov pandemic has further increased the burden on the diabetes population, those at risk of dyglcyaemic changes as well as the healthcare services [ ] . the aim of this article was to provide a comprehensive review of the burden of diabetes pre-covid- and the additional impact sustained by the diabetes population and healthcare systems during the covid- pandemic, while providing recommendations of how this burden can be subsided. a literature search was carried out in july through 'pubmed' and 'google scholar' using the keywords 't dm', 'covid- ' and 'public health'. articles were then filtered using several inclusion criteria including; english language, human studies and literature type. the latter mainly included systematic reviews, meta-analysis and literature reviews. the authors then filtered the resulting articles by title and abstract and the remaining articles which fitted the aim of this review were thus considered. additionally, information was also collected from reliable reports such as those of the world health organization (who) and international diabetes federation (idf). having an understanding of the impact of t dm at an individual, community and population level is paramount for public health authorities and policymakers alike. the burden of a disease can be quantified in terms of the quality of life, morbidity, premature mortality, economic and healthcare impact [ ] . public health policies and plans for provision of services all depend on the general population's state of health and comorbid diseases which change over time. developed in the s, the dalys metric is used to gauge the total burden of a disease by considering the number of years lost to a disease, premature mortality, or disability. it is also used to compare health and life expectancy globally. such a calculation gives policy makers a better understanding of the overall duration of life in comparison to duration spent in poor or good health [ ] . a global observation of the incline in dalys across years comparing individuals at different age categories ( - years, - years vs + years) adapted from the global burden of disease website can be seen in figs. , and respectively. [ ] . as seen in the graphs, the higher incidence of t dm at a younger age range is contributing to the increase in dalys. this will place a strain on healthcare costs and economic healthcare services as well as [ ] decreased work productivity and increased likelihood of early retirement or mortality. this will ultimately be a burden on the country's economy. the universal rise in life expectancy has left policy makers questioning whether individuals maintain a good quality of life during these additional years, as reported by the global burden of disease (gbd) study and illustrated in figs. , and . such evaluations are extremely relevant to decisions involving extension of retirement ages and health care stipulations. namely to increase efforts for risk prevention of non-communicable diseases such as t dm from early stage of the disease. great inequalities between the burden of a disease and healthy life expectancy are present globally irrespective of a country's quintile on the socio-demographic index or between sexes [ ] . this implies that quantity is more prevalent than quality of life worldwide. the disabling outcomes of a disease such as t dm has considerable implications for the health care system plans and disbursements [ ] . economic status and healthcare t dm presents with economic, social and health burdens not only for the individual but also for families and careers as well as the healthcare system. additionally, employment is another social factor which is often impacted, leading to further strain on the country's economy [ ] . a country's ability to prevent t dm lies in the presence of an identification and targeting strategy aimed at high risk individuals. this is dependent on the infrastructure and human resources available with a consequential effect on the management plan of the diagnosed individuals [ ] . furthermore, statistical data regarding epidemiology would be essential for health care providers in the identification of the risk factors contributing to t dm at a country level. this would aid in surveilling, diagnosing, monitoring as well as treating t dm. in previous studies diabetes was reported to be more common with individuals with high socio-economic status [ ] [ ] [ ] . in contrast, a recent study reported that a higher t dm prevalence was associated with individuals having a lower socioeconomic status due to limited access to health care and [ ] . moreover, this factor was also observed in low and middle income asian countries experiencing fast economic advancement [ ] . coronaviruses are enveloped viruses known to cause respiratory infections in humans. whilst most of these viruses are harmless and cause mild symptoms, a novel virus known as sars (severe acute respiratory syndrome) -cov as well as covid- emerged in december of , which proved to be more harmful than the previously known coronaviruses [ ] . it is now a known fact that co-morbidities such as obesity, diabetes mellitus (dm), hypertension as well as advanced age all increase the chances of being infected with covid- [ ] . additionally, reports from the centres for disease control and prevention stated that patients with diabetes and metabolic syndrome might be times more likely to die due to covid- [ ] . there are several possible mechanisms which can make diabetic patients more susceptible to covid- . some of these mechanisms include; impaired macrophage activity; impaired neutrophil recruitment and cytokine storm. however, the one mechanism which seems to be considered most is the increased viral load due to the virus entering the cells efficiently. in fact, the receptor which this virus uses is the angiotensin-converting enzyme (ace ) receptor which can be found expressed by various tissues including lungs, kidneys, pancreas and the heart [ , ] . firstly, the sars cov- spike protein bind to the ace cell surface where the s protein is then primed by the cellular proteases such as tmprss and furin. priming involves cleaving the s protein at the s /s domains, allowing the virus to fuse to the cell surface [ ] . virions are then taken up into endosomes where the sars cov is cleaved and possibly activated by cathepsin l [ ] . inside the cell sars cov replicates itself whilst ace catalyzes the conversion of angiotensin i to angiotensin ii and ace converts angiotensin ii to ang - [ ] . since ace receptors are also found in the pancreas, the entry of coronavirus in the pancreatic cells may result in acute beta cell dysfunction [ ] . finally this may lead to a state of acute hyperglycaemia which if left uncontrolled predisposes the diabetic individual to a greater risk of infection and also a higher chance of mortality [ , ] . certain medications prescribed to diabetic patients such as glp- agonists, angiotensin receptor blockers (arb's) and angiotensin converting enzyme inhibitors (acei's) are thought to upregulate ace expression [ ] . acei initially inhibits the angiotensin converting enzyme (ace) leading to decreased angiotensin i levels. this possibly causes a negative feedback loop that ultimately upregulates more ace receptor which can now interact with the decreased angiotensin i substrate available [ , ] . additionally, evidence of a -fold increase in ace levels with lisinopril and a -fold increase in ace levels with losartan was also published [ , ] . therefore, due to the ace receptor being expressed in various tissues as well as due to the upregulation of ace receptor there is thus an increase in potential binding sites for sars-cov- . this mechanism takes place in patients with diabetes and/or hypertension since they usually take acei or arb's. hence, infection by covid- may be more severe in these patients [ , ] . whilst the above mentioned mechanism seems to confirm that arb's and acei's upregulate ace expression, other studies which contradict this have been published. these studies claim that the administration of these medicines is actually beneficial to patients infected with covid [ ] [ ] [ ] [ ] . lack of exercise one of the many mitigation legislations put forward by governments along with public health authorities to contain the spread of covid- was to institute social-distancing restrictions along with the closure of gyms and parks [ ] . furthermore, the population was advised to limit going out of their homes unnecessarily [ , ] . exercise has long been established to be an important requisite as part of the diabetes management and prevention plans [ ] . several studies carried out over the years found that lifestyle interventions including min/week of physical activity and diet-induced weight loss of - % reduced the risk of progression from impaired glucose tolerance (igt) to type diabetes by % [ ] [ ] [ ] . a systematic review and meta-analysis carried out on structured exercise interventions also concluded that structured exercise programs had a statistically and clinically significant beneficial effect on glycaemic control [ , ] . consequently, the world health organization (who) released a guideline called 'stay physically active during quarantine' which contains possible ways to stay active during covid- . the use of online classes and videos were encouraged as were frequent walking breaks around the house [ ] . the mandated lockdowns resulted in the limited access to fresh fruit and vegetables. individuals including those with diabetes might have resorted to the consumption of long shelf-life canned or packaged foods that are typically high in calories and/or fats, with a potential increase in the consumption of carbohydrates [ ] [ ] [ ] . such food consumption increases the risk of weight gain and impose a higher cardiovascular, thrombotic and respiratory complications [ , ] . the concurrent presence of obesity within the diabetes population poses additional detrimental effects on the functioning capabilities of the lungs lead to a decrease forced expiratory volume (fev) and forced vital capacity (fvc) [ ] . additionally, it has been hypothesized that pulmonary lipofibroblasts together with normal adipocytes play a role in the pathogenic response of covid- . this is believed to be brought about by the increased expression of the ace- receptors which turns the adipocytes into reservoirs for the virus. moreover, the adipocytes aid in the transdifferentiation of lipofibroblasts into myofibroblasts leading to pulmonary fibrosis. consequently, the presence of fibrosis leads to severe outcomes of the covid- infection among the diabetesobese population [ ] . a recurrent issue during lockdown appeared to be an increased 'mental stress' and changes in sleeping habits [ ] . anxiety mainly stemmed from contracting the virus, being restricted to the place of residence for a long period of time and also not being able to meet with loved ones [ ] . the increased levels of anxiety were reported by more than % of the participants from north india who stated that they were worried about covid- , out of which . % reported difficulties in sleeping [ ] . another study carried out in china reported that . % of participants sustained a moderate to severe impact on their mental health due to covid- pandemic [ ] . fig. in the supplement material is a guideline released by the national diabetes service scheme (australia) intended in helping with management of worries and anxiety related to covid- and diabetes [ ] . similarly, the european country of malta also released a set of recommendations to help the local diabetic population in managing their condition as well as to reduce anxiety related to covid- [ ] the national health service (nhs) also published 'guidance for: supporting people with diabetes during the covid- pandemic' which compiles informative websites that the diabetic population might need to access during these difficult times [ ] .apart from these guidelines, a number of countries including the european country of malta, set up designated helpline to provide aid to all those experiencing mental health issues including the diabetes population [ , [ ] [ ] [ ] . whilst covid- and the subsequent stress can be a source of sleep disturbance, one has to also take into account diet; lifestyle and diseases [ ] . in fact, shorter sleep duration and unstable sleeping patterns have been linked to obesity and cardiovascular problems [ , ] . an association was also found between sleep disorders and patients with t dm, where increased rates of insomnia, excessive sleeping during the day and a more frequent use of sleep medications were reported [ ] . these changes in sleeping patterns may be due to the t dm itself as well as due to complications which come with it such as polyuria and peripheral nephropathy [ ] . lockdown restrictions challenged individuals including those with diabetes with inadequate vitamin d levels due to low sunlight exposure during this pandemic [ ] . vitamin d deficiency can lead to an increased mortality and morbidity due to covid- [ ] vitamin d supplementation is not only thought to decrease the risk of infection but it is also being suggested as a cure for infection patients [ ] vitamin d has numerous mechanisms through which it decreases the risks of microbial infections and death. these mechanisms can be grouped into three main categories; physical barrier, cellular natural immunity and adaptive immunity [ ] . it was observed that infected elderly with diabetes had an elevated fasting blood glucose as opposed to their hba c which remained stable [ ] . however, during the acute phase of the covid- infection it is essential that strict glucose control is maintained to prevent the occurrence of complications [ , ] . a number of healthcare recommendations and guidelines have been issued during these unprecedent times by different stakeholders including the institute for healthcare excellence on managing the diabetic population pre-covid- [ ] . examples of these recommendations can be found as part of the supplement material (supplement tables , change in healthcare services due to covid- individuals with diabetes are not always able to self-cafe and modify drug doses, especially those in marginalised and disadvantaged populations as well as elderly deprived of social support. these populations are dependent on health professionals [ ] . in such cases, where no designated point of reference is available, managing their own condition can place further psychological stress on the patients, which might have been the case during the covid- lockdown periods. complications arising from poorly managed blood glucose such as diabetic ketoacidosis raises the risk for morbidity and mortality. this will not only put a strain on an individual and the family unit but also on the health care system [ ] . most outpatient services were temporary halted during the pandemic whilst those that continued their services were challenged due to staff reduction as these were deployment to frontline duties or illnesses [ ] . hence, ensuring that delivery of care does not cease during this pandemic was a great feat. virtual care was a tool employed by many countries in an attempt to continue provision of service whilst also preventing nosocomial exposure to covid- . telehealth was consequently beneficial for countries, such as usa,uk and india, when providing a service in distant locations with shortage of staff [ ] [ ] [ ] . using such technologies enabled imparted education to individuals with diabetes about changes in insulin dosing as well as general self-care. the ongoing communication empower individuals and allow them to independently manage their condition. studies carried out prior to the pandemic indicated that virtual communication can successfully lower hb a c [ ] . practitioners through telemedicine can further emphasize the importance of controlling glucose levels as well as relate the potentially improved outcomes of covid- if encountered [ ] . however, such a tool is not always viable due to limited accessibility, acceptance and knowledge on the use of technology. in fact, some individuals still requested to be seen in the traditional face-to-face setting [ ] . moreover, practitioners in developing countries should always consider financial implications of therapies on an individual. simple treatment regimens and low-cost therapy should ideally be prescribed especially to underprivileged populations [ ] . the guidelines observed in supplement fig. have formulated by the british national health system (nhs) to assess the risk of covid- susceptibility before setting up an outpatient assessment or follow up [ ] . healthcare professionals can potentially encounter clients who are awaiting result or have been confirmed as covid- positive. hence it is essential to encourage staff to wear ppes whilst also adhering to recommended sanitisation procedures; especially in aerosol generating practices. such procedures should also be enforced in hospital routine activities such as waste, food, utensil and laundry handling. bornstein et al., compiled a list of guidelines for healthcare workers to follow when dealing with diabetic patients in different scenarios. these guidelines can be found in fig. in the supplementary material [ ] . easy and practical recommendations that were compiled by wang et al., ( ) that can be relayed to patients are listed in fig. which can be accessed in the supplement material [ ] . the extensive impacts on health revealed by this pandemic has demonstrated the vulnerability of individuals with noncommunicable diseases (ncds) [ ] . a study carried out in italy showed that % of patients that died in hospitals had previous comorbidities, with t dm being second highest amongst hypertension, malignant tumours, cardiac and respiratory diseases [ ] . the link between ncd and covid- mortality has also been made in usa, china and spain [ , , ] . measures undertaken for ncds included quarantine and physical distancing. this could potentially result in poor management of the condition by both the patient -through behavioural risk factors -and the healthcare professional [ ] . rescheduling of routine medical tests and appointments can further hinder management as well as limited access to primary healthcare centres, pharmacies and transport. all these factors will make it tougher to ensure continuity of care. research from other pandemics indicates that exacerbation of ncds occurs without proper healthcare management [ ] . this is due to stress that is brought about by changes in routine, uncertain economic situations and new regulations which will ultimately raise rates of disability, morbidity and mortality in patients with ncds [ ] . the importance of t dm management to avoid serious repercussions on health and overall economy is not a new concept. hence it is important to equip patients with the right knowledge about the current pandemic and its possible effects on their overall health. it is crucial, now more than ever, to ensure that patients have direct contact with a healthcare practitioner to mitigate any queries or concerns that they may have. this will ultimately empower individuals to adhere to recommendations whilst also avoiding extra stressors which may exacerbate hyperglycaemic effects such as kidney failure, amputation, nerve damage and heart disease [ ] . t dm has been a global burden for decades; however, additional burden has been imposed with the onset of covid- pandemic. consequently, at a global level, healthcare systems as well as the diabetes population were impacted during this pandemic. mitigation restrictions that were aimed to curb the spread may have imposed a higher burden on the diabetes population. having an understanding of the different challenges and subsequent burden faced by this vulnerable population will enable healthcare professional, healthcare provision and policy makers to provide targeted action plans. funding no funding was received to conduct this study. 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non-communicable diseases in emergencies difficulties to treatment adherence according to the perception of people living with type diabetes publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -cts n j authors: tam, john s; barbeschi, maurizio; shapovalova, natasha; briand, sylvie; memish, ziad a; kieny, marie-paule title: research agenda for mass gatherings: a call to action date: - - journal: lancet infect dis doi: . /s - ( ) -x sha: doc_id: cord_uid: cts n j public health research is essential for the development of effective policies and planning to address health security and risks associated with mass gatherings (mgs). crucial research topics related to mgs and their effects on global health security are discussed in this review. the research agenda for mgs consists of a framework of five major public health research directions that address issues related to reducing the risk of public health emergencies during mgs; restricting the occurrence of non-communicable and communicable diseases; minimisation of the effect of public health events associated with mgs; optimisation of the medical services and treatment of diseases during mgs; and development and application of modern public health measures. implementation of the proposed research topics would be expected to provide benefits over the medium to long term in planning for mgs. a mass gathering (mg), as defi ned by who, is "any occasion, either organized or spontaneous, that attracts suffi cient numbers of people to strain the planning and response resources of the community, city or nation hosting the event". mgs can be spontaneous or organised and include sports events, social or cultural functions, gatherings of displaced populations due to natural disasters or war, and political or religious congregations. [ ] [ ] [ ] [ ] major mgs are likely to involve communities from diff erent parts of the world. participants and host and home communities face health risks that are of international concern. therefore, the control of infectious diseases and provision of medical services for non-communicable dis eases and other risks to health are increasingly important in the planning for mgs. risks commonly associated with mgs include health systems having to accom modate a surge in capacity; challenges to existing health interventions; introduction and transmission of non-endemic diseases during and after mgs; diffi culties associated with risk communication to participants from diff erent cultures; and those arising because of the high profi le of some events, such as security risks. international mgs can amplify the transmission of infectious diseases, and infections can spread from the home to the host community during travel to and from the event and from the host to the home community on return. such events can pose substantial risks to global health security and present challenges for surveillance of the spread of such diseases to new ecological settings and vulnerable populations. in addition to risks of infectious diseases during mgs, non-communicable risks include cardiovascular diseases, environment-related heat injury, fi re-related injury, illnesses related to use of drugs and alcohol, occupational injuries, trauma or crush injuries associated with stampedes, exacerbation of respiratory diseases, and crowd safety. large mgs can also provide opportunities for terrorist activities. in planning for mgs, international and local health authorities need to ensure that the strengthened public health systems and rapid responses to health risks are integrated with other important components of the overall event management. eff ective public health policy should be based on evidence. the organisation of international mgs generally requires provision of huge amounts of resources by the host country and the dividend of such high visibility is called legacy. this legacy should be measured not just in terms of absolute improvements (eg, new roads and ambulances) but also in terms of improvements to the public health system and society as a whole. for example, the legacies of strengthened integration of clinical or laboratory services, early warning or syndromic surveillance, and fi eld epidemiology or response adopted for the past summer olympics (sydney, australia, athens, greece, and beijing, china) [ ] [ ] [ ] are used routinely in the health systems. the development of eff ective methods for, and improvement of, planning and handling of the health risks associated with mgs will strengthen global health security, prevent excessive emergency health problems and associated economic loss, and mitigate potential societal disruption in host and home communities. such development requires credible evidence to support activities that can reduce the global eff ect of infectious diseases and address local public health issues related to morbidity and mortality resulting from noncommunicable diseases during mgs. however, there are gaps in knowledge about many public health issues that contribute to eff ective planning. , , therefore, a robust knowledge about illnesses, from basic scientifi c understanding to societal eff ects of infections and noncommunicable diseases, is essential for modern public health practices and policy development related to the planning for mgs. several reports [ ] [ ] [ ] [ ] [ ] and who planning and guidance documents , - have drawn attention to the importance series of research into public health issues associated with mgs and identifi ed those that need immediate attention. despite these eff orts, an overarching research agenda based on public health to address the gaps in knowledge in mg health has not yet been developed. moreover, international coordination to prioritise and enable the funding and implementation of such an agenda has been lacking. the recent recognition and rapid development of mg health can provide focus on such issues. previously identifi ed research priorities for mgs tended to focus on logistical issues relating to site security and emergency management, crowd control, and surge in the need for medical services. , other specialties tend to focus on each of the specifi c public health topics that are associated with mgs. much research into existing and emerging infectious diseases is devoted to the development of rapid diagnostic methods, surveillance and response, and treatment and vaccines. although a research agenda based on public health must be underpinned by basic science, applied science and operational research are areas of particular interest to the organisers of mgs and the decision makers for public health, especially those in poorly resourced countries. the modern day idea of mg health has developed from the notion that "mass gatherings medicine is concerned with the provision of emergency medical care at organized events with > people in attendance" to include several specialties (fi gure). the intricate interactions between the diff erent specialties is essential for the planning and success of mgs. new advances or interventions undertaken in other specialties should be integrated with research into mgs. the proposed research agenda is a broad strategy for research into public health, with a focus on issues related to mgs. it is not intended to be an exhaustive compilation of all possible research questions about the strategic planning for and operation of mgs. instead the agenda is an outline of key research into methods to control public health and policy. the results of this research can provide an evidence-based platform for policy decisions and practices to reduce the risks and eff ects of mg-associated health issues and global security risks to public health. the principal objectives of this research agenda are to identify topics for research and underpin and prioritise their importance in achieving interventions for the control of public health; provide a research framework to gather evidence to address health issues associated with mgs and global security risks to public health; ensure focus on less well addressed issues such as operational and implementation research, particularly for under-resourced regions; provide a platform to enable co ordination, discussion, and interaction among organisers of mgs, public health professionals, and researchers; and encourage a multidisciplinary approach to address gaps in knowledge about health risks associated with mgs and their control. the proposed research agenda is organised as a framework of fi ve major public health research directions. although many public health emergencies associated with mgs are not predictable, much can be done to prevent and minimise their eff ects. continuous monitoring of participants' vulnerability to health risks at mgs and understanding trends in risks that are associated with specifi c events (religious, sports, or concerts) can be used to predict what might happen in the future. they are also essential for successful preparedness and management of risk reduction and strengthening the response capacity of host and home communities. recognition and analysis of the changing risks and vulnerabilities during mgs are starting points for raising awareness and communication of pending risks. building global capacity for health intelligence for noncommunicable and infectious diseases is important for the elucidation of the risks associated with mgs. most of this information is available through networks such as the emerging infectious disease networks , and the who global non communicable disease network. importantly, the information can be used to implement strategies for risk assessment and mitigation in planning for specifi c mgs (panels , ). morbidity and mortality at mgs can be mitigated through the assessment and management of risks associated with pre-existing non-communicable diseases. mitigation methods such as the provision of essential drugs and information about their availability at the mg can be initiated during pretravel medical care and advice. , incidence of trauma and heat-related illness at a site can be reduced with the provision of advice and installations to combat the eff ects of weather, and eff ective crowd control. models for the prediction of the spread of infections and occurrence of other emergency health issues during mgs have yet to be validated. many of the diffi culties in restricting the spread of emerging communicable diseases [ ] [ ] [ ] are not new and have proven diffi cult to resolve. there is also uncertainty global clinical and laboratory surveillance systems for communicable diseases, such as those for seasonal and pandemic infl uenza, are well established. the establishment of country-level surveillance systems for infectious diseases that can be adapted to diff erent epidemiological settings for mass gatherings (mgs) could also provide alerts for the occurrence of non-communicable diseases, such as radiation-related or chemical-related illnesses or those caused by extreme environmental temperatures (eg, program for monitoring emerging diseases). an important component of the alert and response strategy is an integrated event management system that provides a platform for rapid dissemination of devices and procedures required for the management of health risks. research into their development and implementation is needed. syndromic surveillance can potentially provide rapid initial information about the occurrence of both non-communicable and infectious diseases. however, its establishment and assessment of eff ectiveness during mgs might require further assessment. further work is also needed to identify appropriate parameters for assessment of the eff ectiveness of such surveillance systems during mgs. surveillance of non-communicable diseases is a formidable but necessary step for the improvement of the health of the global community. an estimated % of global mortality in was attributable to non-communicable diseases and % of such deaths occurred in low-income and middle-income countries. age-specifi c and sex-specifi c profi les of non-communicable diseases by country allow host countries of mgs to estimate possible risks of non-communicable diseases in participants from specifi c countries and plan for mitigation strategies. although the challenges for the organisers of mgs and the eff ects of infectious diseases at such events have been summarised, , there are many gaps in our understanding of emerging communicable diseases. integration of information from local and international surveillance of infectious diseases is important for strengthening the intelligence about the global threats before, during, and after mgs. the risks of non-communicable and infectious diseases during mgs are proportional to the probability of occurrence of risk factors during the event. the identifi cation of these risks factors for the diff erent types of mgs will provide a scientifi c basis for planning eff ective prevention. although major risk factors associated with non-communicable and communicable diseases are likely to be similar worldwide, factors specifi c to the type of mg might lead to health problems. systematic risk assessment helps identify potential risks of outbreaks and guides the establishment of eff ective risk management solutions. systematic assessment will also identify potential or deliberate health security risks that require assistance from other authorities and government agencies. the leading causes of morbidity and mortality during the hajj are heat-related illnesses and trauma-related injuries. identifi cation of such risks allowed event planners to instigate preventive measures and rapid response strategies. provision of shaded areas can reduce the incidence of heat-related illnesses and eff ective crowd control reduces the risk of a stampede. drug and alcohol use were identifi ed as health risks for other types of mgs; therefore, restriction of their use can mitigate the associated illnesses. the types and magnitude of health risks associated with spontaneous mgs due to natural disasters and confl icts are diff erent from those of organised mgs. objectives for risk management at such events are focused on facility-based health-care provision in addition to prevention. the potential for importation and subsequent global spread of infectious diseases during mgs are well understood. many emerging human infections are recognised as zoonotic diseases (eg, severe acute respiratory syndrome [sars], infl uenza a h n , nipah virus infection). the emergence of novel or rare pathogens in home communities and their subsequent spread to the host community and beyond can be amplifi ed during mgs. planning for the potential risks and hazards that are associated with mgs is essential to ensure success. many reports and manuals are available for planning mgs; , - however, their use should be tempered by the results of the risk assessment. importantly, planning should maximise the legacy of the mg. the conceptual model of a lasting public health legacy as a framework for the relation between planning inputs, implementation, and public health outcomes was put forward by who and the international olympic committee to ensure sustainable, positive health eff ects for the host communities after the olympic games. legacy planning should also include passing the knowledge gained to future hosts of similar mgs. series about how observations pertaining to particular pathogens, population groups, or settings can be used to develop public health policies for planning diff erent types of mgs. the development of evidence-based strategies for non-pharmaceutical inter ventions is urgently needed to address infection control and mitigate spread in the absence of available drugs and vaccines. additionally, such strategies are of particular concern for countries that do not have adequate access to pharmaceutical interventions such as vaccines and antimicrobial drugs. in some instances, available data for planning mgs might not have been assimilated in the best way for policy. a balance between basic scientifi c research and operational research is essential to inform the implementation of prevention strategies, best practices, and public health decision making (panel ). research into how to contain the spread of infectious diseases should have the broadest possible applicability in diff erent settings and at diff erent resource levels. however, some results might not be generalisable to the planning for mgs, such as those from studies of pathogen transmission in health-care settings. eff ective management of health risks for noncommunicable and infectious diseases during mgs requires planning in advance. it is an integral part of planning that consists of risk identifi cation, communication, analysis, assessment, prevention, and monitoring. , , many of the processes for risk management of non-communicable and infectious diseases during mgs are common. however, each can be specifi c to the type of mg and needs to be addressed accordingly. , high visibility of mgs complicates risk management and can lead to political and media pressure and thereby aff ect the decision-making process. prevention of the occurrence of non-communicable and infectious disease at mgs requires coordinated risk assessment and management before, during, and after the event as shown in the planning for the hajj. [ ] [ ] [ ] [ ] [ ] ideally, the primary prevention of human infections with emerging communicable diseases is the eff ective control of pathogens at their source. since at-source elimination of all emerging pathogens is not possible, secondary interventions (eg, pharmaceutical or nonpharmaceutical) are needed to mitigate the spread of infection during mgs. however, the eff ectiveness of such interventions has not been established. , in addition to reduction of the rates of morbidity and mortality associated with human infections during mgs, reduction of both the circulation of pathogens and human exposure might lessen the global health security risks. the eff ect of emergencies and crises on health can be substantially reduced if home and host communities are well prepared and are able to reduce their risks. the main challenge during mgs is the existence of systematic operative capacities such as risk assessment plans, coordinating mechanisms and standard procedures, institutional capacities, legislation and budgets, skilled vaccination is highly eff ective in the prevention of infectious diseases. however, many countries, particularly those with insuffi cient resources, have not developed strategies for vaccinating their populations at risk and people travelling to mgs. the reason is partly related to the lack of information about the transmission of infectious diseases (eg, infl uenza) and the social, economic, and health eff ects to the host and home communities. public health authorities need to decide how to eff ectively prioritise vaccine use on the basis of available information about disease burden and severity, epidemiology, and vaccine eff ectiveness and safety for vaccine-preventable infections associated with mgs. a failure to promote and implement the polio vaccination programme caused the re-emergence of poliovirus in nigeria and subsequent international spread, , emphasising the risks associated with insuffi cient vaccine coverage for participants at mgs. an outbreak of neisseria meningitides serogroup a (originating from africa) during the hajj in was later successfully controlled with the introduction of mandatory pretravel vaccination and use of fl uoroquinolones among african pilgrims. however, there are infectious diseases, including some of the most important and most dangerous, for which there are no vaccines. risk assessment and management during the planning for mgs can enable the development of eff ective health policies. strategic risk assessments are used to gather, coordinate, and analyse data that are necessary to identify existing risks, anticipate potential diffi culties, establish • enhance applications of existing vaccines against possible infectious diseases that are associated with mgs • assess the global vaccine supply and production to improve the processes of rapid response, surge in capacity, and rapid deployment and tracking of vaccine use for planning mgs • develop innovative clinical trial methods to study the eff ectiveness and safety of novel vaccines before and after licensing • develop new vaccines, platforms, and formulations that are safe with enhanced immunogenicity, especially in children and elderly people series priorities, and provide the basis for enacting targeted policies and implementation of corrective interventions. a system is needed for the measurement of the eff ect of public health policy and estimation of the probability of success. these interlinking processes are well described for regularly organised events such as the hajj and olympic games. , , an example of the eff ective development of health policy is the organisation of the hajj-such as a smoke-free environment for the prevention of fi re, structural changes to prevent crowding, and recommendations for vaccination of pilgrims to prevent transmission of infectious diseases (eg, infl uenza, meningitis, poliomyelitis). however, such eff ective policies are not possible for spontaneous mgs such as population displacement as a result of natural disasters or confl icts. development of vaccines for emerging infectious diseases presents substantial challenges and can take many years for diseases that are caused by novel pathogens such as severe acute respiratory syndrome (sars; panel ). even if a vaccine exists, it might need to be regularly updated, clinically assessed for safety and effi cacy, and promptly produced for immediate use (eg, infl uenza vaccines). the effi cacy and eff ectiveness of a vaccine are dependent on the immune responses that are determined by the age of the recipient and composition of the vaccine (eg, conjugated or adjuvanted). improvements to vaccines and formulations that can provide longer-lasting and broader activity aff ord better protection, increase the applicability of vaccines, and reduce the frequency of vaccination. during an outbreak, the important factors are the rapid production and equitable distribution of vaccines to countries in need. ensuring rapid and eff ective management of patients and prevention of diseases requires robust health services at mgs. providers of emergency services play an important part in ensuring public safety during such events. knowledge and monitoring of medical service provision during mgs has been rapidly increasing in the past decade. , , however, a lack of consolidated data for diff erent types of mgs means that organisers are not able to plan accordingly for the emergency medical services that might be needed. improved and targeted clinical management and infection control can substantially reduce the incidence and transmission of infectious diseases during mgs. optimum clinical management must be based on an improved under standing of the pathogenesis of these infections, advances in laboratory diagnosis, development and application of eff ective antimicrobial drugs, and other treatment modalities (panel ). there are many gaps in our basic understanding of how many of the pathogens that are associated with mgs cause disease in people and what factors aff ect severity of illness. host immune responses, underlying comorbidity, age, and the properties of the infecting pathogen can all contribute to severity. the clinical presentation of many infections, such as infl uenza, is not specifi c, which makes diff erential diagnosis and early treatment to reduce further transmission and severe outcomes diffi cult. for example, antibiotics can help control severity and further spread of travellers' diarrhoea caused by bacteria. rapid and reliable diagnostic testing can expedite the initiation of timely and appropriate treatment and infection control. increase in and optimisation of the repertoire of antimicrobial drugs immunomodulator drugs, immunoglobulins, and natural products) that are applicable in low-resource areas and in fi eld conditions (such as availability, whether licensed or not, acceptance, and effi cacy in diff erent ethnic, sex, and age groups) and are easy to administer in paediatric-care and emergency-care settings • optimise management of people who are at risk of severe disease and complications, including emergency-care practices that are applicable across a range of resource settings health-care capacity and response • assess the eff ectiveness of global, national, and local responses to outbreaks of communicable diseases and develop new methods for assessment • undertake operational studies to investigate the surge capacity needs, particularly in host countries for mgs, including development of triage schemes in diff erent health-care and resource settings, and surge planning to maintain adequate resources • undertake studies to identify evidence-driven clinical-care pathways and principles that optimise health-care delivery in a range of resource settings • undertake studies to develop principles and practices for rapid assessment and introduction of new interventions during health emergencies, including systems for collation, sharing, and assessment in real time of clinical data series and development of clinical research to assess effi cacy of putative adjuvant treatments such as immunomodulator drugs, passive immuno therapy, and traditional medicine that are suitable for use in under-resourced areas would be most benefi cial in the preparation for mgs (panel ). the availability and quality of health services contributes to the eff ect of infectious diseases in the source and home countries (panel ). the same pathogen that might have a small eff ect on the rates of morbidity and mortality in countries with well organised health-care systems can be devastating in countries where health-care systems are suboptimum. new public health methods need to be harnessed to help reduce the eff ect of health problems during mgs. use of innovative communication channels, such as the internet and mobile phone networks, have the potential to aid surveillance, rapid risk assessment, and dissemination of accurate information. , , mathematical modelling and risk communication have potential applicability in all aspects of research into health risks associated with mgs. some countries and mg organisers use state-of-the-art approaches for early detection and monitoring of diseases such as syndromic surveillance. , in some countries computerised health-care and laboratory-based infor mation systems are used for planning mgs and these systems can be adapted for monitoring large-scale outbreaks. other innovative technologies such as mobile phones can be used in remote areas or countries that lack the resources to gather and transmit health-related data in real time, provide rapid feedback, and train health-care workers. , applicability and use of these modern methods of monitoring in diff erent settings and contexts require further investigation, with special attention to issues related to integration and interoperability of initiatives for infection control during mgs (panel ). evidence-based public health decision making in planning and mitigating health risks requires rapid access to information. however, such information is often incomplete, evolving, and derived from an increasingly complex array of sources such as basic science researchers, epidemiologists, social and political scientists, and economists. modelling is useful in that it can incorporate diverse data to inform public health policy and decision making. , advances in mathematical modelling for public health are expected to include computational structural biology; integration of epidem iological and geographical data into phylogenetic models; within-host and population-level susceptibility models; behavioural modelling; and assessment of the eff ects of climate change on disease transmission and the use of novel datasets on contact patterns and population mobility. [ ] [ ] [ ] [ ] [ ] communication is a key strategy in risk management in planning for mgs. the sars outbreak in reinforced the idea that a timely and transparent public information policy could help reduce excessive and inappropriate public health responses and minimise the social disruption and economic consequences of a fast-moving global epidemic. , increased investment in identifying eff ective approaches and developing and assessing new communication methods will benefi t risk prevention and control eff orts. the specifi c challenge is to provide clear, credible, and appropriate communication to meet the needs of diverse communities and retain public trust in a dynamic yet unknown process. , some of the main research topics in this specialty include the link between communication and behaviour change models; development and assessment of methods that can be quickly accessed and used in mgs; and assessment of best practices, challenges, and barriers in risk research in early detection and monitoring of disease • identify, develop, and adapt modern technologies for early detection of outbreaks of communicable diseases and their application in disease surveillance during mgs • integrate and continuously assess innovative approaches and channels for disease surveillance and monitoring • develop effi cient mechanisms to address the global challenges to sharing information, data, and details about pathogens identifi ed during outbreaks at mgs in terms of local, ethical, legal, and research perspectives • defi ne the timeliness and quality of data required for early detection of disease from local to district, regional, national, and global levels • assess the application of modelling to understand and estimate key parameters for risk management • investigate the role of modelling to assess eff ect of public health policies for diff erent mgs • assess modelling in public health policy planning and strategic decision making in mg planning research into health issues related to mgs is at an early stage. research directions outlined here should contribute to the evidence that can be used to formulate risk management guidelines and assist event planning and health-care policy makers. the research agenda presented here is not intended to be restricted to specifi c aspects of health research but rather to encourage a multidisciplinary approach focused on mg health and to help gain more knowledge. in the future, the focus should be on strategies directed towards developing common research frameworks and defi nitions. additionally, the knowledge generated by use of the multidisciplinary approach to research ought to be assessed for direct relevance to mgs in terms of their capacity for integration in legacy building and systemic sharing of information. jst wrote the text. mb planned the outline for the review, and provided and consolidated who policies and guidelines about mgs. zam provided the concept for the review and planned the content with the team. ns provided the outline and wrote the section about risk communication. sb provided information about outbreak control and research agenda for infl uenza. m-pk contributed information about health research directions and vaccine development. all authors reviewed and provided advice on drafting the review. we declare that we have no confl icts of interests. we identifi ed references for this review by searching pubmed, medline, and the internet for articles published in english from january, , to june, , by using the search terms "mass gatherings", "research", "infectious diseases", "communicable diseases", "non-communicable diseases", "public health", "alert and response", "mass gatherings planning", "legacy", "outbreak", "surveillance", "prevention", "treatment", "olympic games", and "hajj". we reviewed the articles and information found during these searches. additional references cited in the articles were also reviewed. communicable disease alert and response for mass gatherings the hajj: communicable and non-communicable health hazards and current guidance for pilgrims public health surveillance for mass gatherings a literature review of the health and safety risks associated with major sporting events: learning lessons for the london olympic and paralympic games health risks at the hajj global perspectives for prevention of infectious diseases associated with mass gatherings crowd and environmental management during mass gatherings non-communicable health risks during mass gatherings public health legacy: experiences from vancouver and sydney olympic and paralympic games mass gatherings and public health: the experience of the athens olympic games who western pacifi c region. the health legacy of the beijing olympic games: successes and recommendations mass gathering medicine: a review of the evidence and future directions for research the development of conceptual models for mass gathering health preparing for infectious disease threats at mass gatherings: the case of the vancouver olympic winter games the quest for public health security at hajj: the who guidelines on communicable disease alert and response during mass gatherings asia pacifi c strategy for emerging diseases: technical papers mass-gathering medical care: a review of the literature global capacity for emerging infectious disease detection networks and the epidemiology of infectious disease global noncommunicable disease network (ncdnet): report of the first global forum convened by the world health organization who global technical consultation: global standards and tools for infl uenza surveillance infectious disease surveillance and modelling across geographic frontiers and scientifi c specialties who. global status report on noncommunicable diseases who. noncommunicable diseases country profi les emergence of medicine for mass gatherings: lessons from the hajj safe and healthy mass gatherings: a health, medical and safety planning manual for public events who. global forum on mass gatherings communicable disease alert and response for mass gatherings: key considerations who. interim planning considerations for mass gatherings in the context of pandemic (h n ) infl uenza federal emergency management agency, usa. special events contingency planning manual federal emergency management agency, usa. special events contingency planning: job aids manual world health organization writing group. non-pharmaceutical interventions for pandemic infl uenza, international measures non-pharmaceutical public health interventions for pandemic infl uenza: an evaluation of the evidence base nigerian states again boycott polio-vaccination drive global poliomyelitis eradication: status and implications epidemic group a meningococcal disease in haj pilgrims meningococcal disease and travel measuring emergency services workloads at mass gathering events automated vocabulary discovery for geo-parsing online epidemic intelligence use of unstructured event-based reports for global infectious disease surveillance mass gathering medicine: a predictive model for patient presentation and transport rates the impact of mass gatherings and holiday traveling on the course of an infl uenza pandemic: a computational model modeling the impact of global warming on vector-borne infections computational procedures for optimal experimental design in biological systems deterministic epidemic models on contact networks: correlations and unbiological terms how to make predictions about future infectious disease risks modeling and public health emergency responses: lessons from sars sars revisited: managing "outbreaks" with "communications responding to global infectious disease outbreaks: lessons from sars on the role of risk perception, communication and management perceived risk and effi cacy beliefs as motivators of change: use of the risk perception attitude (rpa) framework to understand health behaviors eff ective media communication during public health emergencies. a who handbook communicating uncertainty-how australian television reported h n risk in : a content analysis key: cord- -iof k r authors: ortolani, claudio; pastorello, elide a. title: hydroxychloroquine and dexamethasone in covid- : who won and who lost? date: - - journal: clin mol allergy doi: . /s - - - sha: doc_id: cord_uid: iof k r background: on june , , the who reported over millions of covid- cases worldwide with over half a million deaths. in severe cases the disease progresses into an acute respiratory distress syndrome (ards), which in turn depends on an overproduction of cytokines (il- , tnfα, il- , il- , ccl- and il ) that causes alveolar and vascular lung damage. clearly, it is essential to find an immunological treatment that controls the “cytokine storm”. in the meantime, however, it is essential to have effective antiviral and anti-inflammatory drugs available immediately. pharmacologic therapy for covid- : hydroxychloroquine or chloroquine have been widely adopted worldwide for the treatment of sars-cov- pneumonia. however, the choice of this treatment was based on low quality of evidence, i.e. retrospective, non-randomized controlled studies. recently, four large randomized controlled trials (rcts) have been performed in record time delivering reliable data: ( ) the national institutes of health (nih) rct included hospitals participating all over the world and showed the efficacy of remdesivir in reducing the recovery time in hospitalized adults with covid- pneumonia; ( ) three large rcts already completed, for hydroxychloroquine, dexamethasone and lopinavir and ritonavir respectively. these trials were done under the umbrella of the 'recovery' project, headed by the university of oxford. the project includes participating hospitals in the uk and was set up to verify the efficacy of some of the treatments used for covid- . these three ‘recovery’ rcts concluded definitely: (a) that treatment with hydroxychloroquine provides no benefits in patients hospitalized with covid- ; (b) that treatment with dexamethasone reduced deaths by one-third in covid- patients that were mechanically ventilated, and by one-fifth in patients receiving oxygen only; (c) that the combination of lopinavir and ritonavir is not effective in reducing mortality in covid- hospitalized patients. conclusions: the results of these four large rcts have provided sound indications to doctors for the treatment of patients with covid- and prompted the correction of many institutional provisions and guidelines on covid- treatments (i.e. fda, nih, uk health service, etc.). even though a definitive treatment for covid- has not yet been found, large rcts stand as the gold standards for covid- therapy and offer a solid scientific base on which to base treatment decisions. in many countries, the covid- pandemic flared up rapidly bringing excellent hospitals and efficient national health systems to their knees. the biggest challenges were: dealing with a previously unknown disease, without effective drugs, and a global mortality of %. current data (june , ) from the world health organization clinical and molecular allergy *correspondence: elideanna.pastorello@ospedaleniguarda.it unit of allergy and immunology, università degli studi di milano, asst grande ospedale metropolitano niguarda, milano, italy full list of author information is available at the end of the article (who) leave no doubt about the severity of this pandemic: the number of covid- cases totaled over millions, worldwide, with over half a million deaths [ ] . in severe cases, the disease progresses into interstitial pneumonia with ards [ ] [ ] [ ] , which in turn is largely due to a cytokine (il- , tnfα, il- , il- , ccl- and il- ) overproduction which causes alveolar and vascular lung damage [ ] [ ] [ ] [ ] . presently, we do not have any specific antiviral, chemotherapeutic or vaccine measures, nor do we have an anti-inflammatory drug capable of fighting the 'cytokine storm' . oxygen supplementation and assisted mechanical ventilation are the only two stages of care for respiratory failure during ards; both help keep the patient alive, but neither promotes healing. in , at the beginning of the sars-cov- pandemic, at least anti-inflammatory and antiviral drugs were available and in use, with possible efficacy for covid- : hydroxychloroquine, corticosteroids, remdesivir and lopinavir / ritonavir. the rationale for the use of chloroquine as a drug for covid- was based on the demonstration of its strong antiviral effect on sars-cov in primate cell cultures [ ] . the antiviral effect in vitro was related, first, to the known increase in the ph of endosomes that the virus uses for cell entry and, second, to an impairment of terminal glycosilation of the cellular receptor of sars-cov- , angiotensin converting enzyme , which is the binding site for the drb (determinant receptor binding) of the spike glycoprotein of coronaviruses. furthermore, it has been recently confirmed that chloroquine and, even more markedly, hydroxychloroquine have anti-sars-cov- activity in vitro cell cultures [ ] . in severe cases, covid- is complicated by pneumonia, anatomically characterized by inflammatory alveolar infiltrates and vascular microthrombi. an exaggerated host immune response seems to be an important factor leading to clinical aggravation. these patients have very high inflammatory markers, such as c reactive protein, ferritin, il- and il- . therefore, in these cases, it is rational to try the efficacy of corticosteroids. at the beginning of , however, the use of corticosteroids in covid- was a controversial topic. the situation is well represented on the one hand by the contrary opinion of russel et al. ( ) expressed in their comment published on lancet [ ] . the authors stated that there is no clinical data that indicates a net benefit from corticosteroids in the treatment of respiratory infections due to rsv, influenza, sars-cov, or mers-cov. conversely, they stated that the available observational data suggested an increased mortality and secondary infection rates in influenza, an impaired clearance of sars-cov and mers-cov, and complications of corticosteroid therapy in survivors. on the other hand, in another comment published on lancet, shang et al. [ ] expressed a completely opposite opinion. this was based both on the results of a retrospective study on patients with severe sars pneumonia, which demonstrated a reduction in mortality and hospitalization after treatment with moderate doses of corticosteroids, and, on the results of a study of over patients with severe h n influenza pneumonia, in which a reduction in mortality was observed in patients with an oxygen index lower than mm hg [ ] . given the importance of resolving this disparity of opinion, it was essential to carry out randomized and controlled studies on a large sample of covid- patients evaluating the results in relation to the severity of the disease. among the available antiviral drugs, remdesivir was the most promising to be effective against sars-cov- . this is a small-molecule, monophosphoramidate prodrug of a nucleotide analogue, that is intracellularly metabolized to an analogue of adenosine triphosphate that inhibits viral rna dependent rna polymerases (rdrp), which had demonstrated in vivo antiviral efficacy against ebola virus in non-human primates [ ] . because its mechanism of action on viral rdrp and previous observations of its activity against filoviruses (e.g. ebola) and coronaviruses (e.g. sars-cov and mers-cov) both in vitro and in various models of animal infection [ , ] , it was justified to evaluate its efficacy in covid- in a polycentric rct with a large case series. lopinavir is a protease inhibitor used to treat hiv infections. it is commercially associated with a subtherapeutic dose of ritonavir, which is a pharmacokinetic enhancer and inhibitor of the cytochrome p isoenzyme a resulting in inhibition of the metabolism of lopinavir and an increase in its pharmacological exposure. protease is a key enzyme in coronavirus polyprotein processing and lopinavir and/or ritonavir (lpv / r) showed an antiviral effect against sars-cov- in vitro [ ] . previous observational studies of the efficacy of lpv / r treatment in covid- have obtained conflicting results (positive or uncertain or negative) [ ] . the only rct on covid- patients found no difference between usual treatments and that with the addition of lpv / r [ ] . therefore it was justified to verify the efficacy of this drug through an rct on a large sample of covid- patients. one of the first european studies on covid- treatments was conducted in marseille, france. prof. didier raoult and his team adopted an early drug treatment with hydroxychloroquine and azithromycin in covid- patients with confirmed pneumonia. the same team of researchers had previously shown that the combination of these two drugs was effective against the sars-cov- virus both in vitro [ ] and in vivo [ ] . more than , covid- patients were treated in marseille with a protocol that included: early diagnosis, early isolation and early treatment, with mg of oral hydroxychloroquine, three times daily for ten days and mg of oral azithromicin on day followed by mg daily for the next four days respectively, for at least three days.the results of this treatment were described in a final, overall retrospective study [ ] , and consisted in reduced risks of death, transfer to the icu or hospitalization, and a shorter viral shedding period, against modest side effects. unfortunately, since patients underwent a complete protocol, which included first of all the promptness of each intervention, it is not possible to know if the positive results obtained in covid- patients were attributable only to the drugs, or to the entire protocol used. so far, very few randomized and controlled trials (rcts) have been planned and performed for covid- , despite the great availability of patients and the urgency to demonstrate the effectiveness of the medications that could be used. on the other hand, several open, nonrandomized, studies have been carried out on a limited number of patients, but they have been irrelevant for the purpose of deciding which therapy to use in covid- patients. recently, however, four large rcts, performed in record time and aimed at demonstrating the effectiveness of some drugs in covid- , have finally brought some reliable results. the nih study on remdesivir is an excellent example of what can be done even in emergency conditions [ ] . the study was completed in about a month, with the participation of hospitals, including in the usa, in denmark, in great britain, in greece, in germany, in korea, in mexico and one each in spain and singapore. the study enrolled , covid- pneumonia patients, of whom were assigned to the treatment with remdesivir and to placebo. the results of this study showed the effectiveness of remdesivir in treating covid- patients: the drug was superior to placebo in reducing the recovery time in hospitalized adults with covid- pneumonia (p < . ). mortality was also reduced in patients treated with remdesivir however, this result did not differ significantly from the controls. even though the effects of the drug on sars-cov- are modest, since remdesivir is non-specific for this virus, the study results are reliable and the use of remdesivir's in covid- patients is justifed. however, the most important consequence of the nih rct's results is that it has shown that an analog antiviral inhibitor nucleotide, such as remdesivir, is effective against sars-cov- . this opened the way for researching and testing other drugs in this category to find an effective cure for covid- . in order to correctly establish the effectiveness of some treatments in covid- , the 'recovery' project was created with the intent of performing a series of randomized studies based on a very large sample size. the project involves hospitals of the national health service of england, scotland, wales and northern ireland. the first study completed, on june , , concerned the effectiveness of hydroxychloroquine in covid- [ , ] . during the course of the study, an independent data monitoring committee reviewed every two weeks the results achieved, so that the study could be stopped when the latter were statistically significant and no longer modifiable by a further increase in the number of cases. the committee discontinued the study when it was clear that there was no benefit from the hydroxychloroquine treatment in hospitalized covid- patients. on june , , prof. peter horby and prof. martin landray, chief investigators of the recovery trial, announced that the data was considered conclusive. the rct included a total of , hospitalized patients who had been treated with hydroxychloroquine and , control patients who had received normal treatment (without hydroxychloroquine). patients were eligible for the study if they had clinically suspected or laboratory confirmed sars-cov- infection, and no significant risk for participating in the hydroxychloroquine arm. patients with known prolonged electrocardiograph qtc interval were ineligible for the trial. patients allocated to hydroxychloroquine sulfate received a loading dose of mg at zero and h, followed by mg starting at h after the initial dose and then every h for the next days or until discharge. participants and local study staff were not blinded to the allocated treatment. at randomization, % were receiving invasive mechanical ventilation or extracorporeal membrane oxygenation, % were receiving oxygen only (with or without non-invasive ventilation), and % were receiving neither. no significant difference was found between the two treatment arms in relation to the -day mortality rate (p = . ), and no beneficial effects on the duration of the hospital stay or other outcomes were also reported. similar results were seen across all five prespecified subgroups: i.e. -age, -sex, -days since symptoms' onset, -respiratory support at randomization (e.g. no oxygen received, oxygen only and, invasive mechanical ventilation), -baseline risks. horby and landray concluded that these data convincingly exclude any significant mortality advantage of hydroxychloroquine in hospitalized covid- patients. eleven days after announcing the negative results of the rct on the effectiveness of hydroxychloroquine in covid- , landray and horby, announced the positive results of the "rct recovery" on the effectiveness of dexamethasone in covid- [ , ] . the study protocol involved the enrollment of , patients from over hospitals within the uk national health service. patients were eligible for the trial if they had clinically suspected or laboratory confirmed sars-cov- infection and no medical history of being at substantial risk to participate in the trial. pregnant or breast-feeding women were eligible. of the , patients who underwent randomization from march to june , , underwent randomization to receive either oral or intravenous dexamethasone ( patients) -at a dose of mg once daily for up to days-or to receive usual care alone ( patients). the mean (± sd) age of the patients in this study was . (± . ) years, and % of the patients were female. at randomization, % were receiving invasive mechanical ventilation or extracorporeal membrane oxygenation, % were receiving oxygen only (with or without non-invasive ventilation), and % were receiving neither. in the dexamethasone group, % of the patients received at least one dose of the drug and the median duration of treatment was days. the primary outcome of the study was to evaluate the difference in mortality rate, calculated at days from the start of treatment, between subjects treated with dexamethasone + usual therapy and those treated with usual therapy alone. dexamethasone treatment reduced deaths by one-third in mechanically ventilated patients (p = . ) and by one-fifth in patients receiving oxygen only (p = . ). however, in patients who did not need any breathing support, there was no difference in mortality in the subjects treated with dexamethasone compared to controls (p = . ). finally, on june , , landray and horby announced the completion of a third recovery trial on the effectiveness of the lopinavir-ritonavir combination in covid- patients. this study foresaw the enrollment of , patients in nhs hospitals in the uk but, as in the rcts "recovery", patient enrollment was terminated when the results reached statistical significance [ ] . in this study, , patients were randomized to lopinar-ritonivar and , to usual care alone. no significant differences were found in the primary endpoint of -day mortality (p = . ), and there was also no evidence of any beneficial effects on reduction of the risk of progression to mechanical ventilation or length of hospital stay. among these patients, % required oxygen alone, and % did not require any respiratory intervention, while only % of enrolled patients required mechanical ventilation. this is due to the difficulty of administering a drug by mouth in patients under mechanical ventilation. therefore, in the most severe patients the results still require confirmation. the results of the two "recovery" rcts on hydroxychloroquine and dexamethasone have rapidly changed the panorama of covid- treatments, as well as previous therapeutic provisions. in fact, on june , , the food & drugs administration (fda) revoked the authorization to use hydroxychloroquine and chloroquine, as an emergency treatment for covid- [ ] , while the united kingdom national health service has already announced that the standard of care for covid- patients will now include dexamethasone [ ] . after six months of a generalized and devastating pandemic, a correct scientific experimentation has provided us with two important results on the anti-inflammatory treatment of covid- : ) a lack of evidence of the efficacy of hydroxychloroquine, and, ) evidence that dexamethasone reduces mortality by one third in the most serious form of the disease, i.e. ards. these results are good for improving the perspectives of the treatment for the sars-cov- viral inflammation, but they are more than excellent for providing solid references in order to amend previous errors. they reaffirm the irreplaceable value of evidence-based medicine (ebm), which-as we know-is the only pathway to rely on in diagnostics and therapy, and which was neglected during the panicstricken emergency. this non-compliance has been maintained by many clinical doctors and officials from public health agencies, who authorized the use of a drug for covid- , which was then administered in almost all patients, despite the absence of any sound scientific evidence, and who, at the same time, recommended not to use corticosteroids in covid- pneumonia. the guidelines, published by who and the u.s. national institutes of health, also recommended not to use corticosteroids in covid- , because of a generally accepted concern that, by reducing the immune response, their use could facilitate the worsening of the sars-cov- infection or the occurrence of secondary infections. it may be useful, for the purpose of a broader understanding, to analyze the chapter on corticosteroids in the who document of march "clinical management of severe acute respiratory infection (sari) when covid- disease is suspected. interim guidance. world health organization" [ ] . the statement: "do not routinely administer systemic corticosteroids for the treatment of viral pneumonia outside of clinical trials" was supported by some remarks. remark cited a number of systematic reviews, which however had selected only observational clinical studies that addressed the efficacy and side effects of the corticosteroid treatment of viral pneumonia from sars, h n influenza virus and mers virus, but not from sars-cov- virus [ ] [ ] [ ] [ ] . remark made a conditional recommendation for corticosteroids for all patients with sepsis (including septic shock) [ ] . in the revised who document of may [ ] , in addition to the aforementioned citations, in remark a systematic review was added on the effectiveness of corticosteroids in viral pneumonia [ ] . in this review, observational studies were selected ( for sars, for covid- and one for mers) and one rct (for sars [ ] ). there was no evidence of efficacy of the corticosteroid treatment in these cases of viral pneumonia, but an increase in side effects was reported. the authors of the systematic review, however, concluded that "because of a preponderance of observational studies in the dataset and selection and publication biases our conclusions, especially regarding sars-cov- , need confirmation in a randomized clinical trial". moreover, the latest who document also cites a recent study by villar et al. [ ] : "in addition, a recent trial reported that corticosteroids may reduce mortality in moderate-severe ards". unfortunately, it was not stressed that, at that time, the study by villar et the study concluded that the early administration of dexamethasone reduced the duration of mechanical ventilation and overall mortality in patients with moderate / severe ards (p < . ), while the percentage of adverse events did not significantly differ between the dexamethasone group and the control arms. on june , , the nih updated the pharmacologic intervention section of their covid- treatment guidelines by including panel recommendations to use remdesivir in patients who are on mechanical ventilation or extracorporeal membrane oxygenation, and to use dexamethasone in patients who are mechanically ventilated and in those who require supplemental oxygen but are not mechanically ventilated [ ] . after these four large rcts, it is legitimate to ask ourselves: "who won and who lost?". ebm -which in turn must be based essentially on rct clinical trials-won. all recommendations not based on ebm lost. because they are not exempt from personal opinions, even if expressed in "bona fides" given the situation. regarding the efficacy of glucocorticoids in covid- , an ebm evaluation might have simply stated that there is no evidence for or against treatment with these drugs in general, and that, since february , there is a high quality evidence that dexamethasone reduces the number of days of mechanical ventilation and the mortality in ards, i.e. by villar et al. [ ] . those who made exceptional efforts to organize in a very short time the execution of controlled and randomized trials, with a high participation of patients, aimed at verifying the efficiency of the treatments currently available for covid- -namely nih and "recovery"won. all those who described clinical observations on small numbers of patients without control cases, not only lost, but also confused everybody. in particular, all those who too quickly accepted the widespread opinion that hydroxychloroquine was effective in covid- , without first thoroughly researching if any sound scientific evidence supported this claim, lost. also, many researchers who, having planned excellent rcts in one location only or in few centers, were forced to terminate them early due to the lack of patients, with the consequence that the data obtained were insufficient, unfortunately lost. a new phase of clinical trials to evaluate the efficacy of drugs for covid- is currently opening up. indeed, a wide variety of drug screening assays, to explore the potential effectiveness on sars-cov- of old and new molecules, are currently underway. for example, in nonhuman primates and in cell cultures in vitro, there are at least drugs, selected from a chemical library that contains nearly , drugs, that have a good chance of being effective against sars-cov- [ ] . our experience with the recent pandemic taught us that the most efficient and fastest way to verify the clinical efficacy of new antiviral drugs is: first, the realization of rcts with wide participation of patients hospitalized for covid- , and second (and above all), the mandatory involvement of both international and national governmental health agencies, to organize, manage and control these necessary large trials. these institutions in turn will have to make extensive use of the structural and organizational resources of the national health services present in their countries, as the recovery collaborative group in the uk taught us. although many mistakes were made during choices of treatments for covid- patients during this pandemic, the lesson that derives provides us with a reassuring message for the future: rigorous scientific research will find anti-sars-cov- treatments and ebm will be able to confirm which of these treatments is effective and safe. world health organisation clinical features of patients infected with novel coronavirus in wuhan china clinical characteristics of coronavirus disease in china baseline characteristics and outcomes of patients infected with sars-cov- admitted to icus of the lombardy region italy pathogenic t cells and inflammatory monocytes incite inflammatory storm in severe covid- patients pathological findings of covid- associated with acute respiratory distress syndrome the definition and risks of cytokine release syndrome in covid- -affected critically ill patients with pneumonia: analysis of disease characteristics adjunct immunotherapies for the management of severely ill covid- patients chloroquine is a potent inhibitor of sars coronavirus infection and spread in vitro antiviral activity and projection of optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory syndrome coronavirus (sars-cov- ) clinical evidence does not support corticosteroid treatment for -ncov lung injury cao b on the use of corticosteroids for -ncov pneumonia therapeutic efficacy of the small molecule gs- against ebola virus in rhesus monkeys broad-spectrum antiviral gs- inhibits both epidemic and zoonotic coronaviruses prophylactic and therapeutic remdesivir (gs- ) treatment in the rhesus macaque model of mers-cov infection remdesivir, lopinavir, emetine, and homoharringtonine inhibit sars-cov- replication in vitro antiviral treatment of covid- a trial of lopinavir-ritonavir in adults hospitalized with severe covid- in vitro testing of combined hydroxychloroquine and azithromycin on sarscov- shows synergistic effect convenient online submission • thorough peer review by experienced researchers in your field • rapid publication on acceptance • support for research data, including large and complex data types • gold open access which fosters wider collaboration and increased citations maximum visibility for your research: over m website views per year ready to submit your research ? choose bmc and benefit from hydroxychloroquine and azithromycin as a treatment of covid- : results of an open-label non-randomized clinical trial outcomes of , covid- patients treated with hydroxychloroquine/azithromycin and other regimens in marseille, france: a retrospective analysis. travel medicine and infectious disease remdesivir for the treatment of covid- -preliminary report statement from the chief investigators of the randomised evaluation of covid- therapy (recovery) trial on hydroxychloroquine effect of hydroxychloroquine in hospitalized patients with covid- : preliminary results from a multi-centre, randomized, controlled trial dexamethasone in hospitalized patients with covid- -preliminary report world health organization (world health organization sars: systematic review of treatment effects corticosteroids as adjunctive therapy in the treatment of influenza the influence of corticosteroid treatment on the outcome of influenza a (h n pdm )-related critical illness corticosteroid therapy for critically ill patients with middle east respiratory syndrome corticosteroid therapy for sepsis: a clinical practice guideline clinical management of covid- : interim guidance impact of corticosteroid therapy on outcomes of persons with sars-cov- , sars-cov, or mers-cov infection: a systematic review and meta-analysis effects of early corticosteroid treatment on plasma sars associated coronavirus rna concentrations in adult patients dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial national institutes of health. covid- treatment guidelines. coronavirus disease (covid- ) treatment guidelines discovery of sars-cov- antiviral drugs through large-scale compound repurposing springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors would like to acknowledge novartis farma for the native english check of the manuscript and for the payment of the publication fees and alessia ortolani, phd for editing the manuscript.. the two authors named contributed equally to the manuscript. eap is the corresponding author. writing -original draft co and eap review & editing: eap and alessia ortolani (non author); conceptualization: co & eap; bibliography investigation: co. all authors read and approved the final manuscript. claudio ortolani, md, is emeritus director of the department of internal medicine of the niguarda ca ' granda hospital in milan; he is currently director of the istituto allergologico lombardo at the casa di cura ambrosiana in cesano boscone (milan) with a freelance contract; he is a member of the american association for the advancement of sciences (aaas), he declares that he has no potential conflicts of interest; elide anna pastorello, md, is associated professor of allergology and clinical immunology at the università degli studi di milano; director of the unit of allergy and immunology and responsible for the regional referral unit for the prevention, diagnosis and treatment of allergic conditions at asst gom niguarda of milano, italy, she declares that she has no potential conflicts of interest. no funding was received for the preparation of the article. we received a contribute by novartis farma for the publication fees. not applicable. not applicable. not applicable. the authors declare that they have no competing interests. key: cord- -zemaygnt authors: johnson, stephanie b. title: advancing global health equity in the covid- response: beyond solidarity date: - - journal: j bioeth inq doi: . /s - - - sha: doc_id: cord_uid: zemaygnt in the coming weeks and months sars-cov- may ravage countries with weak health systems and populations disproportionately affected by hiv, tuberculosis (tb), and other infectious diseases. without safeguards and proper attention to global health equity and justice, the effects of this pandemic are likely to exacerbate existing health and socio-economic inequalities. this paper argues that achieving global health equity in the context of covid- will require that notions of reciprocity and relational equity are introduced to the response. while much of the world's attention is currently focused on europe and the united states, experts worry that in the coming weeks and months sars-cov- may ravage countries with weak health systems and populations disproportionately affected by hiv, tuberculosis (tb), and other infectious diseases (nordling ) . at the same time, the trump administration has been accused of offering a german medical company "large sums of money" for exclusive access to a coronavirus disease vaccine (oltermann ) . according to an anonymous source, trump was aiming to secure a vaccine against the coronavirus for the united states, "but for the us only." it was also reported that the german government was offering its own financial incentives for the vaccine to stay in the country. this stark example reveals the unfairness and inequities of the global political and health systems. unfortunately, inequitable distribution of vaccines is not the only way in which global inequities can be reproduced. without safeguards and proper attention to global health equity and justice, the effects of this pandemic are likely to exacerbate existing health and socio-economic inequalities. global coordinated efforts in response to covid- led by international organizations such as unicef and the world health organization (who) have attempted to integrate notions of global "solidarity" into practice and policy. in this paper we explore how solidarity is used in this context and how it can be manifest. we argue that achieving global health equity in the context of covid- will also require that other equityorientated perspectives, namely reciprocity and relational equity, must be introduced to the response. in april , the un general assembly unanimously adopted a resolution calling for increased global solidarity and international cooperation against the novel coronavirus outbreak. similarly, in april the who and unicef initiated the covid- solidarity response fund. unicef ( ) reports that "money collected through the fund will be used, among others, to train and equip communities and health-care workers to prevent, detect and treat covid- . it will help countries expand their health-care capacity and mitigate its social impact." similarly, the who publication addressing human rights as key to the covid- response sets out that [u] nder international human rights law, the obligations undertaken by state parties beyond their borders, i.e. to international assistance and cooperation are akin to their domestic obligations, not subsidiary or secondary in any way. covid- is a reminder, not only of the global connectedness of the pandemic, but also of its solutions. providing lmics with international assistance and cooperation, both fiscal and technical, is crucial not only to individual nations' efforts to address this pandemic but also to global efforts. (world health organization , ) while "solidarity" is presented as the conceptual umbrella under which these moral and practical commitments fall, several reasons are offered for the importance of global solidarity: ) it is legally required, ) it will help lmics address the outbreak in their own countries, and ) global cooperation will also be instrumental in avoiding a second wave of infection in high-income countries. in this regard, solidarity is used instrumentally to avert crisis in highincome countries and also as a moral basis for a commitment to countries elsewhere. the bioethical literature offers differing views on conceptual understanding of solidarity and the practical work that "global solidarity" might be able to do. in the context of global health, solidarity is often invoked normatively in connection with providing assistance to poor countries (prainsack and buyx ) . some, however, including gostin et al. ( ) , reject the notion of solidarity as "aid" and endorse an understanding of mutual assistance between countries motivated by a sense of shared duty, as distinct from charity (prainsack and buyx ) : framing global health funding as "aid" is fundamentally flawed because it presupposes an inherently unequal benefactor-dependent relationship. rather, global collaboration requires a collective response to shared risks and fundamental rights, where all states have mutual responsibilities. charitable giving usually means that the donor decides how much to give, for what and to whom. consequently, aid is not predictable, scalable or sustainable. it undermines the host country's ownership of-and responsibility for-health programmes. (gostin et al. , ¶ ) prainsack and buyx offer that of authors writing about solidarity and global health, most agree that solidarity should help to materialize a better distribution of resources and more equal access to healthcare across the globe. they also argue that "in its most bare-bones form, solidarity signifies shared practices reflecting a collective commitment to carry 'costs' (financial, social, emotional, or otherwise) to assist others" (prainsack and buyx , ) . solidarity is understood as a practice and not as an inner sentiment or an abstract value, one that can be reflected across three tiers: the individual, the institutional, and the legal and contractual (prainsack and buyx ) . dawson and jennings deny that "costs" are a necessary requirement for solidarity. they "hold solidarity to be a deep and enmeshed concept, a value that supports and structures the way we in fact do and ought to see other kinds of moral considerations" (dawson and jennings , ) and suggest that "the foundational aspect of solidarity can be captured by the fundamental idea of 'standing up beside'" ( ). this is taken to have several key elements: solidarity requires a public action; the purpose of the action is orientated towards improving or correcting past or present disadvantage or injustice; and what is important is that action does not derive out of expectation of benefit from the other but out of moral concern for that other (dawson and jennings ) . what all this demonstrates is that it is "impossible to give an uncontroversial definition of solidarity" (dawson and jennings , ) . solidarity is conceptually contested; the concept often poorly defined in practice and by most accounts does not imply direct obligations. solidarity can therefore fail to manifest in a meaningful way when aiming to advance global health equity. further, solidarity does not incorporate important ethical and moral dimensions of global equity. that is to say "solidarity," by most accounts, fails to account for the contributions that lmics make to global health security and what they may be owed in return. theories of justice from political philosophy most often establish obligations for parties from highincome countries owed to parties from low-and middle-income countries (pratt and loff ). yet, in recent decades, global collaborative efforts have formed a key part of addressing emerging infectious disease threats. the global health security agenda (ghsa), for example, is a group of countries, international organizations, ngos, and private sector companies that have come together to advance a world safe and secure from infectious disease threats (ghsa ). thirty-one countries around the world are partnering to reach the goals of the ghsa, under which nations make new, concrete commitments to elevate global health security as a national leaders-level priority (ghsa ). in the research domain, important work to develop globally compatible surveillance systems has been ongoing (gardy and loman ) . indeed, ongoing surveillance is a core part of covid- global strategy. recognition of the required collaborative nature of disease detection means research practices have evolved within the scientific community, emphasizing openness, transparency, networks, and free exchange (laird et al. ). the covid- pandemic has seen unprecedented levels of collaboration and openness. nextstrain, for example, is an open repository that pulls in data from labs around the world that are sequencing sars-cov- 's genome and centralizes it in a phylogenetic tree (berditchevskaia and peach ) . researchers have also been sharing new findings about the virus's genomic profile through open source publications and preprint sites such as biorxiv and chinaxiv (berditchevskaia and peach ) . what all this demonstrates is that lmics are not merely the recipients of knowledge and resources. as others have noted "northern researchers are not selfsufficient benefactors providing capacity-building and strengthening resources. they need the data, samples, skills, experience and expertise contributed by their southern partners" (parker and kingori ) . "reciprocity is generally understood to be based on the notion of mutual regard and fair play. reciprocity demands an appropriate balancing of the benefits and burdens of the social cooperation necessary to obtain the good of public health" (viens et al., , ) . global pathogen threat detection systems create both burdens and benefits. benefits may include creation of technologies and vaccines and increased healthcare and surveillance capacity in lmics. similarly, burdens may include use of resources, risks to privacy (through data-donation), and undesirable political or trade consequences. countries that have participated in global surveillance and have borne the costs and burdens are owed something in return. this is true whether the downstream benefits of that participation have yet been realized or can be measured. so far, we have taken a distributive view of justice. relational egalitarians have proposed a different way of conceptualizing equity which focuses not on distributions as inherently important but instead on the quality of social relations among citizens and/or the ways in which social institutions "treat" citizens (voigt and wester ) . in this context, other ways in which equity might be reflected in current and future pandemic responses is in the processes through which policies are designed and decided upon. participation in decisions about public health policy in particular should increase the involvement of marginalized groups as "agents" of policy rather than merely recipients (weinstock ) . this could play out on many levels; here we focus on geopolitical issues and international science. progress is required in this regard so that existing and historical injustices are not perpetuated or exacerbated. recent polling of the international advisory board of the lancet global health on questions of authorship and recognition illustrate some of the challenges that continue to arise in ensuring fair involvement and recognition of researchers in lmics. the greatest challenge being the greater power and resources of their partners and a lack of consensus on what is "fair" (the lancet global health ). in january , the nuffield council of bioethics report research in global health emergencies: ethical issues (nuffield council of bioethics ) highlighted the research fairness initiative guide to high-quality reporting on measures and conditions that promote fair research partnerships (research fairness initiative ). recommendations include, amongst others, early engagement of all partners; data ownership, storage, access, and use during and after research for lmic partners; and specific measures to share intellectual property rights in collaborative research (research fairness initiative ). of the more than three hundred clinical trials that have been launched to find a treatment for covid- , most are in china and south korea, with more developing in the united states and europe (roussi and maxmen ) . very few are taking place in africa, latin america, and south and southeast asia (roussi and maxmen ) . early trial entrants for the who's solidarity clinical trial, which seeks to compare the effectiveness of four drugs and drug combinations in treating covid- , are from europe, where countries have some of the highest covid- cases. but so far the only country in africa to have formally joined the trial is south africa (roussi and maxmen ) . this has significant implications for the applicability of trial results to different populations. if the benefits of research are to be achieved and a just global response to covid- realized, this will be dependent upon both distributive and relational concerns. a successful global research effort will require attention to the ways in which all partners are treated and the ways in which priorities, interventions, and policies are decided upon. in their qualitative study examining the ethics of global research collaborations, parker and kingori ( ) found that addressing ethical concerns in global research collaborations is not only morally desirable, but is required for collaborative global health research to be both successful and sustainable. the successful functioning of global health research networks and hence the successful production of scientific knowledge was seen by scientists in the global south to include an interweaving of scientific, practical, and moral practices. these include the building and maintaining of trust, paying careful attention to fairness in the recognition of efforts, ensuring that scientists in low-income settings are able to meet their obligations to local communities, and the promotion of mutual respect (parker and kingori ) . addressing the covid- pandemic will require global efforts in surveillance and public health, bringing together scientists, practitioners, policymakers, governments, and many other global health actors. a substantial bioethics literature exists around global health equity and in particular on the ethical distribution of vaccines and the conceptualization and requirements of global solidarity. in this paper we have argued that global health equity in the context of the covid- response can be further advanced by acknowledging the role that lmics play in global science, as well as through attention to the ethical aspects of collaborative working and the processes by which scientific knowledge is produced and policies decided (parker and kingori ) . funding information the author is supported by a wellcome centre grant ( /z/ /z) and a wellcome strategic award ( ). open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creativecommons.org/licenses/by/ . /. coronavirus: seven ways collective intelligence is tackling the pandemic. the conversation the place of solidarity in public health ethics towards a genomics-informed, real-time, global pathogen surveillance system ghsa (global health security agenda). . global health security agenda national and global responsibilities for health rethink the expansion of access and benefit sharing closing the door on parachutes and parasites a ticking time bomb": scientists worry about coronavirus spread in africa research in global health emergencies: ethical issues trump "offers large sums" for exclusive access to coronavirus vaccine. the guardian good and bad research collaborations: researchers' views on science and ethics in global health research solidarity in contemporary bioethics-towards a new approach a framework to link international clinical research to the promotion of justice in global health research fairness initiative african nations missing from coronavirus trials unicef. . who and unicef to partner on pandemic response through covid- solidarity response fund, p r e s s r e l e a s e your liberty or your life: reciprocity in the use of restrictive measures in contexts of contagion relational equality and health world health organization. . addressing human rights as key to the covid- response publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -xpzqd wk authors: kabamba nzaji, michel; ngoie mwamba, guillaume; mbidi miema, judith; kilolo ngoy umba, elie; kangulu, ignace bwana; banza ndala, deca blood; ciamala mukendi, paul; kabila mutombo, denis; balela kabasu, marie claire; kanyki katala, moise; kabunda mbala, john; luboya numbi, oscar title: predictors of non-adherence to public health instructions during the covid- pandemic in the democratic republic of the congo date: - - journal: j multidiscip healthc doi: . /jmdh.s sha: doc_id: cord_uid: xpzqd wk background: adherence to public health instructions for the covid- is important for controlling the transmission and the pandemic’s health and economic impacts. the aim of this study was to determine the associated factors of non-adherence to public health and social measures instructions. methods: this was a cross-sectional study conducted with participants in two provinces of drc, mbuji-mayi, and kamina. predictors of non-adherence to covid- preventive measures were identified using binary logistic regression analysis. p-value< . was considered as a significant predictor. results: among participants ( [ . %] male, age . [ . ] years), . % were defined as non-adherents. non-adherence was associated with never studied and primary education level [adjusted odds ratio (aor)= . , ci= . – . ], unemployed status [aor= . , ci= . – . ], living in kamina (haut-lomami province) [aor= . , ci= . – . ], female gender of head of household [aor= . , ci= . – . ], no attending lectures/discussions about covid- [aor= . , ci= . – . ], not being satisfied with the measures taken by the ministry of health [aor= . , ci= . – . ], not been regularly informed about the pandemic [aor= . , ci= . – . ], and bad knowledge about covid- [aor= . , ci= . – . ]. conclusion: the rate of non-observance of preventive measures for the covid- pandemic is high, and different factors contributed. the government has to counsel the permanent updating of messages taking into account the context and the progress of the pandemic by using several communication channels. coronaviruses (cov) are zoonotic pathogens that can be transmitted via animal-tohuman and human-to-human interactions. they are known to cause diseases including the common cold and severe acute respiratory syndrome (sars). originating from the city of wuhan, hubei province, china, the novel coronavirus ( -ncov) is rapidly spreading to the rest of the world. the circumstantial evidence that links the first case of covid- to the huanan south seafood market that sells various exotic live animals suggests that the zoonotic coronavirus crossed the barrier from animal to human at this wet market. it has since become a global public health emergency. the world health organization (who) designated covid- a pandemic on march , . the african region remains the least affected continent, with , cases and deaths, but the numbers are increasing. covid- is majorly affecting many countries all over the world, whereas africa is the last continent to be hit by the pandemic. many countries around the world are majorly affected by covid- , but africa is the last continent to be hit by the pandemic. the first case of covid- in africa was confirmed in egypt on february , , and nigeria reported the first confirmed case in sub-saharan africa, in an italian patient who flew to nigeria from italy on february , . the government response to the pandemic on the continent has not been without challenges. airport screening has been implemented and mitigation efforts such as hand washing, social distancing, and stay-at-home lockdown measures have also been adopted. however, in the longterm these measures are unsustainable due to the socioeconomic dynamics in most african states. in the democratic republic of the congo (drc), the first covid- case was reported on march , . according to the latest report from the drc covid- taskforce and ministry of health, the numbers of infected people in drc reached on may , including deaths. since the first case of -ncov was registered in the drc, no cases have been reported in mbuji-mayi and kamina. vaccine may not be available in the early stages of a pandemic. so, non-medical measures such as the promotion of individual protection (hand hygiene and face masks), imposing travel restrictions, and social distancing of possibly infected cases are essential to reduce the possibility for new infections. the willingness of the general public plays an important and decisive role in achieving such measures recommended by public health authorities. it remains the health issues to lead the population to observe unconditionally these recommended preventive actions. however, it remains difficult to motivate people to adopt preventive behavior. risk perception is identified as one of the factors contributing to an increase in public participation in adopting preventive measures. , a high level of people's risk perception can influence the intention to adopt protective measures. effective risk communication is an essential element of outbreak management. receiving information through different origins such as the ministry of health, frontline workers, and social media can affect the public's knowledge about the risk perception and community engagement, thereby influencing their decision to adopt protective measures. , it is therefore important to understand how the populations risk perception and their engagement. the best way to limit the spread of the covid- depends on public adherence to the public health instructions. the aim of this study is to identify predictors of non-adherence to public health instructions. an analytical cross-sectional survey was conducted in the towns of mbuji-mayi (kasai oriental province) and kamina (haut-lomami province) in drc, in may . the target was the female or male population, aged at least years living in both cities for at least months. we included all participants who gave consent to participate in the study and were found at home at the moment of the survey. we excluded those who did not give consent for participation in the study and were not found at home at the moment of the survey. the sample size was calculated using the following formula: n≥(zα .p.q)/d , where the p represents the proportion of non-adherence to public health measures during the covid- pandemic (we assumed that p= % because this proportion in the drc is unknown), q( −p), z-value of the standard normal distribution corresponding to a significance level of alpha of . ( . ) and d the precision degree that we assumed to be % too. the minimal size computed was participants. a total of participants present in the health facilities were selected. data were collected with the use of a semi structured tablet-based questionnaire, which consisted of two parts: demographics and kap. demographic variables included age, gender of interviewee, gender of head of household, marital status, religion, current employment status, town, and the source information of covid- related knowledge. the second part included questions regarding submit your manuscript | www.dovepress.com journal of multidisciplinary healthcare : covid- related knowledge, and the last seven questions probing for observance to each of the instructions released to the public by the ministry of health. participants were assured that the information collected would remain anonymous. a correct answer was assigned point, whereas an incorrect/unknown one was assigned points. the total knowledge score ranged from - , and a cut-off point for covid- related knowledge level was : individuals with a score < were considered as having poor knowledge, whereas a score of or higher indicated good knowledge. the dependent variable, non-adherence to the instructions, was measured by seven questions probing for observance to each of the instructions released to the public by the ministry of health. the mean score on the non-adherence for each participant to the instructions scale was ≤ . ethical approval was obtained from the ethics committee of the school of public health (approval letter no unilu/ cem/ / ), university of lubumbashi, and drc in accordance with the declaration of helsinki. participants were informed that participation was on a voluntary basis. informed, verbal consent was obtained from each study participant, which was approved by the ethics committee, and that this study was conducted in accordance with the declaration of helsinki. data were analyzed using spss . software. the continuous and categorical variables age, gender, marital status, level of education, religiousness, gender of head of household, city of residence, current employment status, exposure to media, heard about novel coronavirus, attended lectures/discussions about covid- , satisfied with the measures taken by the ministry of health, are presented as frequencies and proportions. binary logistic regression analysis was used to identify the predicting factors of non-adherence to the instructions for the covid- pandemic. variables that appeared to be associated (p< . ) in the unadjusted analyses were further adjusted for demographic factors (ie, age, gender, education) using stepwise logistic regressions. associations with a p-value< . in the adjusted analyses were considered to be statistically significant. the overall data are described in table . in summary, of the respondents, . % were - years old and . % were years or older, . % were men and . % of head of household were women, . % were married, . % had a secondary education level, . % identified as religious, . % lived in mbuji-mayi, . % were unemployed, and . % were exposed to media. the majority of the participants ( . %) had heard about novel coronavirus and only . % had attended lectures/ discussions about covid- . more than a third of the participants ( . %) were consequently defined as nonadherents to the instructions of the ministry of health for the covid- pandemic. table presents the analysis results for non-respect of the measures for the covid- pandemic by people. the following background variables predicted non-adherence: female gender, age lower than years, never studied, and primary education level, unemployed status, living in kamina (haut-lomami province), female gender of head of household, non-media expose, not heard about novel coronavirus, no attending of lectures/discussions about covid- , not been satisfied with the measures taken by the ministry of health, not been regularly informed about the pandemic, and bad knowledge about covid- . table presents the multivariate logistic regression analysis, the following variables predicted non-respect of the instructions for the covid- pandemic: never studied and primary education level, unemployed status, living in kamina (haut-lomami province), female gender of head of household, not attending lectures/discussions about covid- , not been satisfied with the measures taken by the ministry of health, not been regularly informed about the pandemic, and bad knowledge about covid- . the discriminant analysis shows that the values of the area under the curve (auc) indicate a predictive capacity on non-respect of the measures for the covid- pandemic of . or % (auc between . and . ) (figure ). understanding characteristics of people who do not comply with covid- -related public health measures is essential for developing effective public health campaigns in the current and future pandemics. to reduce the covid- transmission and impact, in the context of absence of vaccines or curative medical treatment, high adherence to public health measures is crucial. the success of this approach is best measured by the public's willingness to comply. a number of public opinion polls suggest that the public generally abides by these measures. the study shows that non-respect of public health measures for covid- can be predicted by never studied and primary education level, unemployed status, living in kamina (haut-lomami province), female gender of head of households, no attending lectures/discussions about covid- , not been satisfied with the measures taken by the ministry of health, not been regularly informed about the pandemic, and bad knowledge about covid- . people's engagement to an effective public response to an emergency requires clear communication and trust. [ ] [ ] [ ] in the epidemic context, there is no sufficient time for dialog or feedback because immediate actions are required. in such conditions, the communication for development is no more a required approach than the risk communication and the community engagement. in democratic and non-democratic societies, risk reduction measures such as social distancing and lockdown cannot be coercive. people must understand what is required and be persuaded of the need to comply with it. risk perception, behavioral changes, and trust in government information sources change when pandemics are progressing. , gender, income, geography, or social interactions are important determinants of recommended public health behavior. [ ] [ ] [ ] it should be noted that the population of kamina did not non-adhere to public health instructions. our study shows that not been regularly informed about the pandemic and bad knowledge about covid- are factors of non-adherence to public health instructions. while more information is available, the ministry of health has to update the messages to achieve effective risk communication in the outbreak context. this is essential not only to instruct and motivate the community to adopt preventive measures, but also to build trust in public health authorities and prevent misconceptions. emotional aspects like anxiety play a role in decision-making. health authorities have to recognize these emotional aspects and take them into account in their risk communication. concerning educational level, a person whom never studied and primary education level had non-respect of public health measures for covid- . no link is established between the education level and the behavior to be avoided. in the uk, during the swine flu pandemic, research showed that people without a diploma were more likely to adopt diagonal segments are produced by ties. dovepress protective attitudes (for example, avoiding crowds or public transport), while in hong kong, higher educated people have been shown to be more likely to avoid public places during the sars outbreak. in australia, it was found that people with higher education were more likely to report expected compliance. on the whole, the instruction allows the adoption of protective and avoidant behaviors, while some results have remained inconclusive. a strength of our study was represented by the fact that the survey was conducted quickly in the most critical period when health authorities recommended the compliance to various barrier measures anywhere and anytime. this study has also limitations. first, despite using probabilistic sampling so that personal characteristics of the sample broadly reflected those in the general population, we cannot be sure that survey respondents are representative of the general population in both provinces. second, the data presented in this study are self-reported and partly dependent on the participants' honesty and recall ability; thus, they may be subject to recall bias. in conclusion, the present study indicates factors related to non-adherence on public health measures during the covid- pandemic in the drc. the non-adherence to these public health instructions can increase risk for the transmission of the pandemic. effective risk communication and community engagement are important to protect the public during the covid- pandemic. based on the results, we recommend the permanent updating of messages taking into account the context and the progress of the pandemic by using several communication channels (radio, newspapers, tv, social networks, etc). during these times, we believe that frontline workers, community health workers, and students in medical sciences can be useful as effective and trustworthy human resources against this pandemic. the change in declared willingness to comply with public health measures in the pandemic concern is necessary for the successful response and containment of the disease. the authors report no conflicts of interest for this work. novel coronavirus (covid- ) knowledge and perceptions: a survey of healthcare workers (preprint) epidemiology of coronavirus covid- : forecasting the future incidence in different countries public responses to the novel coronavirus ( -ncov) in japan: mental health consequences and target populations critical supply shortages -the need for ventilators and personal protective equipment during the covid- pandemic covid- pandemic -an african perspective covid - : a perspective on africa ' s capacity and response leveraging africa's preparedness towards the next phase of the covid- pandemic comment limiting the spread of covid- in africa -: one size mitigation strategies do not fit all countries covid- epidemiological status in democratic republic of congo lay perceptions of the pandemic influenza threat lay perceptions of the pandemic influenza threat perceived threat, risk perception, and efficacy beliefs related to sars and other (emerging) infectious diseases: results of an international survey responding to global infectious disease outbreaks: lessons from sars on the role of risk perception, communication and management perceived risk of covid- pandemic: the role of public worry and trust precautionary behavior in response to perceived threat of pandemic influenza sources of information and health beliefs related to sars and avian influenza among chinese communities in the united kingdom and the netherlands, compared to the general population in these countries non-compliance with covid- -related public health measures among young adults: insights from a longitudinal cohort study communicating about emerging infectious disease: the importance of research public health measures during an anticipated in fl uenza pandemic: factors in fl uencing willingness to comply monitoring the level of government trust, risk perception and intention of the general public to adopt protective measures during the influenza a (h n ) pandemic in the netherlands the dynamics of risk perceptions and precautionary behavior in response to (h n ) pandemic influenza perceived risk, anxiety, and behavioural responses of the general public during the early phase of the influenza a (h n ) pandemic in the netherlands: results of three consecutive online surveys demographic and attitudinal determinants of protective behaviours during a pandemic: a review social capital and health-protective behavior intentions in an influenza pandemic contextual and psychosocial factors predicting ebola prevention behaviours using the ranas approach to behaviour change in guinea-bissau public perceptions, anxiety, and behaviour change in relation to the swine flu outbreak: cross sectional telephone survey a tale of two cities: community psychobehavioral surveillance and related impact on outbreak control in hong kong and singapore during the severe acute respiratory syndrome epidemic pandemic influenza in australia: using telephone surveys to measure perceptions of threat and willingness to comply the journal of multidisciplinary healthcare is an international, peerreviewed open-access journal that aims to represent and publish research in healthcare areas delivered by practitioners of different disciplines. this includes studies and reviews conducted by multidisciplinary teams as well as research which evaluates the results or conduct of such teams or healthcare processes in general. the journal covers a very wide range of areas and welcomes submissions from practitioners at all levels, from all over the world. the manuscript management system is completely online and includes a very quick and fair peer-review system. visit http://www.dovepress.com/testimonials. php to read real quotes from published authors. key: cord- -mydyc y authors: mcdiarmid, melissa a. title: hazards of the health care sector: looking beyond infectious disease date: - - journal: ann glob health doi: . /j.aogh. . . sha: doc_id: cord_uid: mydyc y background: possessing every hazard class, the health care sector poses significant health threats to its workforce in both high-resource settings and low- and middle-income countries (lmics). objectives: the aim of this paper was to examine the applicability of the classical hierarchy of hazard control technologies in resource-constrained health care settings. methods: using a biologic and chemical hazard example, the hazard control hierarchy was applied for risk mitigation. findings: even when resource constraints force a reordered selection of hazard control elements, risk reduction can be achieved across a variety of hazard classes. conclusion: for lmics with limited resources, the hazard control hierarchy can be effectively employed, although the selection of methods may be reordered, to achieve significant hazard control. such prevention strategies can thereby strengthen and sustain a critical pillar of the health system, its workforce. it is counter-intuitive that the health care industry, whose mission is the care of the sick, is itself a "high-hazard" industry for the workers it employs. this industry sector consistently demonstrates poor workforce injury and illness statistics, among the highest in the united states and in the european union (eu), about % higher than the average work-related accident rate. in both the united states and the eu, about % of all workers are employed in the health care sector. this workforce is overwhelmingly female, even in some low-and middle-income countries (lmics), with about % of the total being women workers. with such a large portion of the global workforce being employed in this high-hazard sector and with forecasts for the increasing need for health workers in the future, the magnitude of the health threat is considerable and demands address. a significant array of hazards is posed by the sector, with biologic agents and infectious diseases the most widely recognized. indeed, such "health careeacquired" infections in patients, other unintended errors, such as medication overdoses, and the known side effects of hazardous treatments have recently spawned the highly visible "patient safety movement." less apparent, however, has been the risk to health that those same hazards and this same environment impose on the men and women who work there. although preventing exposure to infectious agents and musculoskeletal injuries resulting from patient lifting have been the primary focus of employee safety programs, the chemical hazards in health care have been more slowly recognized. these include novel agents, some of which are unique to health care such as sterilants, germicidal agents, and pharmaceuticals including the highly toxic anticancer drugs. many of these drugs are themselves cancer-causing or toxic to human reproduction and have been the subject of environmental monitoring campaigns in recent years, showing widespread work-area contamination. in the context of this highly complex and hazardous work environment, particular challenges arise in pursuing protections for health care workers in this unique employment sector. biases within the health care industry and the safety and health community itself collude to limit both the awareness of hazards that do exist and the successful application of classical approaches used to assure safe jobs. this occurs for several reasons. because health care is a nontraditional employment setting, imagined by the public to be clean and safe, hazard awareness often is lacking. also, due to its unique mission of caring for the sick, self-preservation behaviors, which normally aid in protecting workers, are suspended in a culture of self-less commitment to patient care. there is an erroneous "either/or" mentality historically present that sometimes forces a false choice to be made by a worker between providing good care or protecting oneself. importantly, these threats to caregiver health have been named as critical factors in the us nursing shortage according to the american nurses association (ana), which published in a recent study that health and safety of the work environment impacts nurses' decision to stay in the profession. internationally as well, conditions of work and health threats have been found to contribute to the current global shortage of health workers. in a recent document from the world health organization (who), "monitoring the building blocks of health systems," the health workforce is described as one of the essential pillars of a strong and sustainable health system. although enlarging capacity through skills building and training is emphasized to bolster the health workforce, also discussed in the prevention of workforce shortages is mitigation of "losses caused by death, retirement, career change or out-migration." clearly, failing to address health threats in the work environment will be a barrier to retaining and sustaining caregiver ranks, which in turn, threaten the delivery of health care globally. workers in the health care sector, which possesses every hazard class, may encounter health threats both common to other workers, such as those related to large facility operations and maintenance, including asbestos, heavy metals, and solvents, and those hazards unique to the provision of care to ill patients. a number of excellent reviews of hazard management in the healthcare sector have been published , - and the reader is directed to these resources. however, several overarching hazards require specific address, due both to their strategic threat to the global health workforce and because they are eminently preventable. biologic hazards, airborne, and bloodborne pathogen exposure biologic hazards are encountered in all health care settings and include airborne and bloodborne pathogens. certainly the best-known airborne hazard is tuberculosis (tb), but other agents are also acquired by the airborne route, such as measles and severe acute respiratory syndrome and most recently, middle east respiratory syndrome. critical elements of an airborne hazard prevention plan are the early identification and isolation of patients as well as administrative and work practice controls to minimize exposure and disease transmission. in the long arc of the unfolding of the hiv pandemic, one little-known development has been the unintended effect experienced by health care workers in some settings in southern africa. due to the endemicity of hiv infection in these regions, including among health care workers, and the often fatal collusion of tb infection in the already hiv infected, there have been alarmingly high tb infection rates and losses of life among nurses and other health workers. often, the typical tb prevention and treatment services afforded hiv patients may not be sought by hiv-infected health workers, due to the stigma they would experience with public knowledge of their hiv condition, which can occur when they line up for tb preventive treatment at the same clinics where they worked, for example. because of this, the morbidity and mortality among workers was substantial, even as many of the countries in the region were already hobbled by a health worker shortage. against this backdrop, in , a new initiative was launched jointly by the who, international labor organization (ilo), and unaids to protect health workers. joint who-ilo-unaids policy guidelines were issued for improving health worker access to hiv and tb prevention, treatment, care, and support to curb this alarming, preventable loss of life among health workers. this initiative promotes worker education regarding tb exposure risk and urges that prevention and treatment services be provided at points of care, while maintaining the privacy of health workers. such occupational health services currently are not widely available in these affected areas, but could be provided by building upon some existing clinical and infection control resources. as well, awareness must be brought to local and regional health ministers that threats to the health care workforce also threaten the viability of health systems with the loss of caregivers to preventable disease and death. indeed, the who identifies the health care workforce as of essential pillars of its health system strengthening initiative. bloodborne pathogens, which include viruses capable of causing hepatitis or hiv infections continue to threaten health workers in both high-resource areas and in lmics. in developing countries, % to % of hepatitis b (hbv) and c virus (hcv) infections in health care workers were attributed to percutaneous occupational exposure. in industrialized countries, such infections rates are lower, with % to % of infections for hcv attributable to occupation and around % for hbv. these lower rates are due to immunization and post-exposure prophylaxis (pep). the range of hiv infections related to occupational exposure is estimated at . % to %. the likelihood of infection occurring after a percutaneous exposure has been observed to occur in a specific order with hbv infections ( %- %) > hcv ( . %) > hiv infections ( . %) displaying generally a -fold difference in infection likelihood between each of these agents. [ ] [ ] [ ] [ ] health workers are at risk for exposure to bloodborne pathogens while performing routine duties involving the use of "sharps" such as injection needles and from unsafe sharps disposal. the who has many resource guides to protect health workers from exposure to bloodborne viruses, the elements of which include: ) the use of "universal or standard" precautions-a system of work practices and behaviors that minimizes exposure such as prohibition of manual needle recapping after use and safe sharps disposal; ) availability of hepatitis b immunization for health workers; ) use of personal protective equipment (ppe) and apparel such as use of gloves; and ) post-exposure management (including prophylaxis, where appropriate) counseling, and support. although health threat interventions in lmics have largely targeted infectious disease risks, the who recently has enlarged its focus to include chronic disease prevention. this is in acknowledgment that nearly % of noncommunicable disease deaths- million annually-occur in lmics. chronic disease includes heart and respiratory disease, cancer, and diabetes. therefore, widening the focus of attention given to occupational health threats related to the treatment of chronic disease must become a part of a comprehensive safety and health plan for the sector. "exposure to potentially hazardous chemicals is a fact of life for health care workers," according to stellman in her overview article on chemical hazards in health care. examples include laboratory reagents and chemicals required in diagnostic or therapeutic procedures. pharmaceuticals are of increasing concerning, especially the hazardous anticancer chemotherapy drugs, which are highly toxic and require vigilance in their use and handling. the term hazardous drug was first applied to most anticancer and some other limited classes of drugs by the american society of health-system pharmacists and was adopted by the occupational safety and health administration and the national institute for occupational safety and health in their publications promoting safe handling practices. drugs are classified as hazardous if studies indicate that exposures to them have the potential for causing cancer in animals or humans, or if they cause developmental or reproductive toxicity, or other organ-system damage. most hazardous drugs are those used to treat cancer but also include hiv therapies and other antiviral agents. occupational exposures to hazardous drugs can lead to acute effects such as skin disorders, allergic reactions, and hair loss; and chronic effects, including adverse reproductive events and possibly cancer. in the pan american health organization (paho) monograph, "safe handling of hazardous chemotherapy drugs in low resource settings," a safer approach to handling these highly toxic, but lifesaving drugs is described when resource limitations might mitigate against "state-of-the-art" practices, but the hazard, nonetheless, requires address. because these drugs require extensive manual manipulation during formulation (compounding) of the patient dose, there is opportunity for worker exposure. a heavy reliance on worker training, ppe use, and scrupulous work practices must be applied to minimize worker exposure. the paho document provides a detailed approach to safe handling of hazardous drugs in resource-constrained settings. in its document "recommendations for protecting healthcare workers' health," international commission on occupational health called for a "systematic occupational risk prevention program" for health care workers to include training regarding work risks and the provision of protective measures, as an integral part of an administrative process addressing health care quality. the basic occupational health approach to minimizing exposure to any workplace hazard uses a combination of protective industrial hygiene control methods that are applied in a specified order or hierarchy. this approach has achieved success across many industrial settings. in most cases, the elements of this hierarchy can be applied to the health care setting (fig. ) . the hierarchy of hazard control technologies relies on engineering controls, such as a biological safety cabinet, a glove box, or other type of hazard barrier or containment, as the first technology applied. however, engineering solutions often are the most costly type of hazard control. in resource-limited settings where engineering controls are unaffordable or otherwise not feasible, scrupulous use of work practices that minimize aerosol and dust generation along with administrative controls that limit personnel access to areas where hazards are encountered can minimize exposure. figure displays this upside-down hierarchy approach. importantly, the lack of resources for the more costly elements of a hazard control approach does not relieve the facility from responsibility from applying some of the control measures that are available to make the work setting the most safe it can be, even in the setting of resource constraints. the hierarchy of hazard control technologies relies first on engineering controls, as just described. for the airborne hazard example of tb, early identification and isolation of potentially infectious patients, in a negative pressure room, is the ideal "engineering" intervention to minimize exposure to airborne mycobacterium. however, in settings where such negative pressure isolation rooms are not available, other administrative and work practice controls of the airborne hazard can be applied, such as placing the infectious patient in a single room away from others. in some locations, a cough-inducing procedure, such as obtaining a sputum specimen, may occur outside, away from other patients. in situations where "engineered" sharps with safety features are not available, careful work practice controls, such as refraining from manual recapping of needles, can mitigate needle-stick injuries. for preparation of hazardous, anticancer drugs when the engineering control containment of a biologic safety cabinet is not available, applying a work practice of preparing drugs in low-traffic and clean preparation areas, and controlling personnel access to this area can minimize the number of workers potentially exposed to fugitive drug aerosol, as described in the paho document. although only hazard types (biologic and chemical) are discussed in detail here, the "hierarchy of hazard control" approach can effectively be employed to limit exposure to other hazard classes and sources of risk to health workers including musculoskeletal risks of patient lifting , and workplace violence. in both well-resource settings and in lmics, the health care workforce is threatened daily with harm from exposure to agents encountered in this unique and complex workplace. even here, however, the classical hierarchy of hazard control technologies can still be effectively applied to mitigate risk. importantly, the selection of hazard control methods may be reordered in low-resource settings to provide some, albeit not ideal, hazard control. as lmics enlarge their prevention services beyond infectious disease control, other health care hazards related to chronic disease care, such as cancer will require programmatic address by occupational health staff to protect and retain the vital health workforce, which is a fundamental pillar of all health systems. healthcare illness and injury statistics gender in health workforce to err is human, building a safer health system niosh (national institute for occupational safety and health/cdc) a nora report: state of the sector: healthcare and social assistance preventing occupational exposures to antineoplastic drugs in health care settings chemical hazards in health care: high hazard, high risk, but low protection american nurses associations (ana) working together for health. the world health report monitoring the building blocks of health systems: a handbook of indicators and their measurement strategies healthwise work improvement in health services trainers' guide health and safety of workers in the health sector: a manual for managers and administrators health workers. health worker occupational health guidelines for preventing the transmission of mycobacterium tuberculosis in health care settings tb in health care workers in the joint who-ilo-unaids policy guidelines on improving health worker's access to hiv and tb prevention, treatment, care and support services: a guidance note preventing needlestick injuries among healthcare workers: a who-icn collaboration sharps injuries: global burden of disease from sharps injuries to health-care workers. geneva: world health organization update on the subject of epidemiology of blood-transmitted occupational infections a caseecontrol study of hiv seroconversion in health care workers after percutaneous exposure joint who/ilo guidelines on post exposure prophylaxis (pep) to prevent hiv infection aide mémoire for a strategy to protect health workers from infection with bloodborne viruses preventing chronic disease: a vital investment chemcial in the health care environment. geneva: international labor organization ashp technical assistance bulletin on handling cytotoxic and hazardous drugs osha instruction ted (training and education directive), . directorate of technical support: controlling occupational exposure to hazardous drugs niosh alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings international commission on occupational health (icoh) and the international social security association (ssa). recommendations for protection health care workers' health patty's industrial hygiene and toxicology safe lifting programs at long-term care facilities and their impact on workers' compensation costs sit-stand powered mechanical lifts in long-term care and resident quality indicators national institute for occupational safety and health (niosh). violence occupational hazards in hospitals key: cord- - jtd ytz authors: zhang, wen-rui; wang, kun; yin, lu; zhao, wen-feng; xue, qing; peng, mao; min, bao-quan; tian, qing; leng, hai-xia; du, jia-lin; chang, hong; yang, yuan; li, wei; shangguan, fang-fang; yan, tian-yi; dong, hui-qing; han, ying; wang, yu-ping; cosci, fiammetta; wang, hong-xing title: mental health and psychosocial problems of medical health workers during the covid- epidemic in china date: - - journal: psychother psychosom doi: . / sha: doc_id: cord_uid: jtd ytz objective: we explored whether medical health workers had more psychosocial problems than nonmedical health workers during the covid- outbreak. methods: an online survey was run from february to march , ; a total of , chinese subjects participated. mental health variables were assessed via the insomnia severity index (isi), the symptom check list-revised (scl- -r), and the patient health questionnaire- (phq- ), which included a -item anxiety scale and a -item depression scale (phq- ). results: compared with nonmedical health workers (n = , ), medical health workers (n = ) had a higher prevalence of insomnia ( . vs. . %, p < . ), anxiety ( . vs. . %, p < . ), depression ( . vs. . %; p< . ), somatization ( . vs. . %; p < . ), and obsessive-compulsive symptoms ( . vs. . %; p < . ). they also had higher total scores of isi, gad- , phq- , and scl- -r obsessive-compulsive symptoms (p ≤ . ). among medical health workers, having organic disease was an independent factor for insomnia, anxiety, depression, somatization, and obsessive-compulsive symptoms (p < . or . ). living in rural areas, being female, and being at risk of contact with covid- patients were the most common risk factors for insomnia, anxiety, obsessive-compulsive symptoms, and depression (p < . or . ). among nonmedical health workers, having organic disease was a risk factor for insomnia, depression, and obsessive-compulsive symptoms (p < . or . ). conclusions: during the covid- outbreak, medical health workers had psychosocial problems and risk factors for developing them. they were in need of attention and recovery programs. the coronavirus disease (covid- ) outbreak is a pandemic [ ] in which a coronavirus has been identified as the cause of an outbreak of respiratory illness. it was first detected in wuhan, china [ ] , but covid- is becoming an increasing public event being a rapid epidemic [ , ] . according to the official website of the world health organization [ ] , as of march , , more than , people have been confirmed to have a covid- infection globally. many accomplishments on covid- , including virus information, clinical features, and diagnosis have been achieved, but no effective treatment is available yet [ , [ ] [ ] [ ] . medical health workers are first-line fighters treating patients with covid- . every day, they face a high risk of being infected and are exposed to long and distressing work shifts to meet health requirements. in brief, they are exposed to a protracted source of distress which may exceed their individual coping skills, being, according to a clinimetric definition [ ] , in allostatic load, which is likely to result in overload with protracted time [ ] . despite messages mentioning that medical health workers' mental health should be emphasized during the campaign against covid- [ ] [ ] [ ] , no research on mental health problems in medical health workers after the maximum point of the covid- epidemic in china has been reported. since chinese medical health workers have been exposed to a persistent source of distress, the aim of the present research was to outline its psychological manifestations. for this purpose, the prevalence and potential factors contributing to insomnia, anxiety, depression, obsessive-compulsive symptoms, somatization symptoms, and phobic anxiety were detected. design, participants, and procedure this is a cross-sectional study performed via an online survey run from february to march , . the study was performed weeks after the covid- epidemic outbreak in wuhan [ ] . this survey period corresponded to the reducing stage after the maximum point of the covid- epidemic outbreak in china [ ] , i.e., the highest vulnerability period after the great distress. persons in the nation with at least years of age were welcome to join in the online survey via the wenjuanxing platform (https:// www.wjx.cn/m/ .aspx). the online survey included questions on sociodemographic and clinical variables. a simple math question (i.e., - = ?) was added at the end for ensuring the quality and completeness of the questionnaire. thus, participants who had not completed the survey received from the online platform a warning on unanswered questions when they did the math question. the online platform did not give warnings to those who gave up. as a result, participants were those who completed all questions of the online survey. demographic data, i.e., sex, age, occupation (medical health workers, i.e., medical doctors and nurses, and nonmedical health workers, excluding nonmedical personnel working in hospitals/ medical institutions), marital status (i.e., married, unmarried, divorced, and widowed), living area (i.e., urban and rural), living with families (yes or no), education status (≤ years, i.e. junior high school and lower, > years, i.e. senior high school and higher) were collected via ad hoc questions as well as the information of a risk of contact with covid- patients in hospitals. participants were also asked whether they have had insomnia or psychiatric disorders prior to covid- (those who replied positively were automatically excluded by the platform) and whether they were having organic diseases (the question was "do you currently have any organic disease? [diagnosed by medical examination in the hospital]"). in addition, insomnia, anxiety, depression, somatization, obsessive-compulsive symptoms, and phobic anxiety were assessed. insomnia was assessed via the insomnia severity index (isi), a -item self-report index assessing the severity of initial, middle, and late insomnia [ ] . an isi total score > indicates that insomnia is present [ ] . the item "since the outbreak, how long (in minutes) did you usually take to fall asleep each night?" was added to assess the degree of sleep onset latency in medical health workers. this item was rated as , , , and (i.e., ≤ , - , - , and > min, respectively). anxious and depressive symptoms were assessed via the patient health questionnaire- (phq- ) [ ] , which is an ultra-brief self-report questionnaire with a -item anxiety scale, named generalized anxiety disorder -item (gad- ), and a -item depression scale, named patient health questionnaire -item (phq- ). in screening of depression and anxiety, a cutoff ≥ in gad- and phq- is recommended [ ] . somatic symptoms, obsessive-compulsive symptoms, and phobic anxiety were measured via the symptom check list- revised (scl- -r) [ , ] , a -item self-report scale with items rated on a -point likert scale (from "not at all" to "extremely"). subscale scores ≥ indicate potential psychological issues [ ] . the chinese versions of isi [ ] , phq- [ ] , gad- [ ] , and scl- -r [ ] were used; they were validated and showed excellent psychometric properties. statistical analyses χ tests were used to compare group differences of categorical variables. mann-whitney tests were used to compare independent groups on continuous variables nonnormally distributed. psychother psychosom doi: . / multivariate logistic regression analyses were performed using stepwise variable selection, and all variables were entered into the model to explore independent influence for different risk dimensions, such as insomnia, anxiety, depression, somatization, obsessive-compulsive symptoms, and phobic anxiety. subgroup analyses were performed for medical and nonmedical health workers. all hypotheses were tested at a significance level of . . data analyses were run via sas statistical software, version . (sas institute inc.). nationwide, a total of , participants from china (see online supplement ; for all online suppl. material, see www.karger.com/doi/ . / ) completed the survey. table presents sociodemographic features of the whole sample and compared medical health workers ( medical doctors and nurses) to , nonmedical health workers. medical health workers showed higher prevalence rates of insomnia ( . vs. . %, p < . ), anxiety ( . vs. . %, p < . ), depression ( . vs. . %; p = . ), somatization ( . vs. . %; p < . ), and obsessive-compulsive symptoms ( . vs. . %; p < . ) than nonmedical health workers. medical health workers also had higher total scores of isi (p < . ), gad- (p < . ), phq- (p = . ), and on the scl- -r obsessive-compulsive symptom scale (p < . ) than nonmedical health workers. each item of isi (p < . or p < . ), gad- (p < . ), and phq- (p = . ) was significantly elevated in medical health workers compared with nonmedical health workers. on the scl- -r obsessive-compulsive symptom scale, of the items had higher scores in medical health workers than in nonmedical health workers. in the scl- -r somatization symptoms scale, of items, including questions (headaches) (p = . ), (faintness or dizziness) (p < . ), and (trouble getting your breath) (p < . ), had higher scores in medical health workers than in nonmedical health workers. no difference on phobic anxiety between both groups was found ( table ) . the multivariate logistic regression analyses ( medical health workers during the covid- epidemic had high prevalence rates of severe insomnia, anxiety, depression, somatization, and obsessive-compulsive symptoms. they also had risk factors for developing insomnia, anxiety, depression, obsessive-compulsive symptoms, and somatization. thus, the presence of these symptoms in addition to the life status of daily fighting against covid- suggests that they must cope with psychological distress and are at risk of allostatic overload [ ] . indeed, according to clinimetric criteria, allostatic overload can be diagnosed in the presence of a current identifiable source of distress in the form of recent life events and/or chronic stress; the stressor is judged to tax or exceed the individual coping skills when its full nature and full circumstances are evaluated. in addition, the stressor is associated with difficulty in falling asleep, restless sleep, early morning awakening, lack of energy, dizziness, generalized anxiety, irritability, sadness, demoralization; significant impairment in psychother psychosom doi: . / social or occupational functioning; and feeling overwhelmed by the demands of everyday life [ ] . the reasons for the psychological distress to which medical health workers were exposed might be related to the many difficulties of being safe at work, such as the initially insufficient understanding of the virus, the lack of prevention and control knowledge, the long-term workload, the high risk of exposure to patients with covid- , the shortage of medical protective equipment [ , ] , the lack of getting rest [ ] , and the exposure to critical life events [ ] , such as death. exemplifications of such a distress are: ( ) of the nurses at the pohang medical center in north gyeongsang province resigned due to overwork among the covid- epidemic [ ] ; ( ) > , medical health workers in (wuhan) hubei province were infected with covid- at a very early stage (before and in january of ). later, with continuously updated guidelines on how to handle the patients with covid- [ ] , with rest in shifts for medical staff, with rapid supply of medical protective items (including masks, glasses, and suits), and with training on the novel coronavirus infection pneumonia diagnosis and treatment plan for all medical staff [ ] , no doctors have been infected with covid- among about , medical personnel from the nation supporting hubei medical services [ ] ; and ( ) as of the th march, medical health workers in one hospital of wuhan died due to being infected with covid- [ ] . our report found potential risk factors for medical health workers to develop insomnia, anxiety, depression, obsessive-compulsive symptoms, and somatization. undoubtedly, these risk factors might endure allostatic overload and favor the development of psychopathology, including chronic insomnia [ ] . independent factors (i.e., currently having organic disease, living in rural areas, being at risk of contact with covid- patients in hospitals, or being female) were common risk factors for insomnia, anxiety, depression, and obsessive-compulsive symptoms among medical health workers. when faced with the same covid- during the fight against the epidemic, medical health workers in rural areas might worry about being infected due to a different working place involving different medical skills and medical conditions. in contrast, the medical conditions in urban areas were often much better. thus, different directions on caring for the medical health workers might be possible. adequate working conditions and recovery programs, i.e., programs favoring activities required to ensure the best physical, mental, and social conditions so that medical workers may progress towards an optimal state of health [ ] , seem necessary. this may support medical staff in adapting to the working environment quickly and maintain a better mental and health balance to be able to work. lowering job demands and workload [ ] , while increasing job control and reward might help to protect medical health workers. individual interventions adequate for medical staff in the current situation, where they wear medical protective equipment which cannot be removed during work time, are still unknown. story sharing [ ] would be important as well as reinforcing the positive assets of persons [ ] . simple, easy, practical methods are needed. electronic devices, such as mobile phones and computers, may help. the present study has limitations. first, a cross-sectional design was applied although a longitudinal approach might help verifying whether allostatic overload develops (exhaustion may ensue after some time) and whether psychiatric disorders, especially posttraumatic stress disorder, might occur with the covid- progression. second, psychological assessment was based on an online survey and on self-report tools. the use of clinical interviews is encouraged in future studies to draw a more comprehensive assessment of the problem. third, it is not possible to assess the participation rate since it is unclear how many subjects received the link for the survey. in conclusion, a higher prevalence of psychological symptoms was found among medical health workers during covid- as well as risk factors for them. medical health workers are in need of health protection and adequate working conditions, e.g., provision of necessary and sufficient medical protective equipment, arrangement of adequate rest, as well as recovery programs aimed at empowering resilience and psychological well-being [ ] . world health organization who characterizes covid- as a pandemic early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia covid- : too little, too late? lancet covid- : surge in cases in italy and south korea makes pandemic look more likely world health organization who statement on cases of covid- surpassing china medical treatment expert group for covid- . clinical characteristics of coronavirus disease in china a pneumonia outbreak associated with a new coronavirus of probable bat origin remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus ( -ncov) in vitro clinical characterization of allostatic overload. psychoneuroendocrinology -ncov epidemic: address mental health care to empower society the mental health of medical workers in wuhan, china dealing with the novel coronavirus online mental health services in china during the covid- outbreak beijing: central steering group: over , medical staff in hubei were infected in the early stage of the epidemic, currently no infection reports among medical aid staff the insomnia severity index: psychometric indicators to detect insomnia cases and evaluate treatment response. sleep (basel) comparing the effects of mindfulness-based cognitive therapy and sleep psycho-education with exercise on chronic insomnia: a randomised controlled trial a -item measure of depression and anxiety: validation and standardization of the patient health questionnaire- (phq- ) in the general population symptom check list (scl- ) re-testing reliability, validity, and norm applicability of scl- psychological results of patients with persisting gastroesophageal reflux disease symptoms by symptom checklist -revised questionnaire the effect of e-aid cognitive behavioral therapy in treating chronic insomnia disorder: an open-label randomized controlled trial. zhonghua jing shen ke za zhi value of patient health questionnaires (phq)- and phq- for screening depression disorders in cardiovascular outpatients reliability and validity of gad- and gad- for anxiety screening in cardiovascular disease clinic world health organization shortage of personal protective equipment endangering health workers worldwide hubei had more than , medical infections, and the wuhan health and medical committee reported "none" for half a month evaluating life events and chronic stressors in relation to health: stressors and health in clinical work london: coronavirus: doctors collapse from exhaustion as virus spreads through south korea beijing: two departments issue the novel coronavirus infection pneumonia diagnosis and treatment plan wuhan central hospital, infected with covid- , died, totally five died in the hospital effect of transcranial alternating current stimulation for the treatment of chronic insomnia: a randomized, doubleblind, parallel-group, placebo-controlled clinical trial rehabilitation in endocrine patients: a novel psychosomatic approach a systematic review including meta-analysis of work environment and burnout symptoms sharing a traumatic event: the experience of the listener and the storyteller within the dyad well-being therapy: treatment manual and clinical appliatios current psychosomatic practice the authors would like to thank all participants for their time and excellent cooperation. the authors declare that they have no conflicts of interests. all participants provided their online informed consent. the study was approved by the local ethics committee on human research. key: cord- -biur xn authors: zickfeld, janis h.; schubert, thomas w.; herting, anders kuvaas; grahe, jon; faasse, kate title: correlates of health-protective behavior during the initial days of the covid- outbreak in norway date: - - journal: front psychol doi: . /fpsyg. . sha: doc_id: cord_uid: biur xn the coronavirus outbreak manifested in norway in march . it was met with a combination of mandatory changes (closing of public institutions) and recommended changes (hygiene behavior, physical distancing). it has been emphasized that health-protective behavior such as increased hygiene or physical distancing are able to slow the spread of infections and flatten the curve. drawing on previous health-psychological studies during the outbreak of various pandemics, we investigated psychological and demographic factors predicting the adoption and engagement in health-protective behavior and changes in such behavior, attitudes, and emotions over time. we recruited a non-representative sample of norwegians (n = ) during a -day period (march – ) at the beginning of the covid- outbreak in norway. employing both traditional methods and exploratory machine learning, we replicated earlier findings that engagement in health-protective behavior is associated with specific demographic characteristics. further, we observed that increased media exposure, perceiving measures as effective, and perceiving the outbreak as serious was positively related to engagement in health-protective behavior. we also found indications that hygiene and physical distancing behaviors were related to somewhat different psychological and demographic factors. over the sampling period, reported engagement in physical distancing increased, while experienced concern or fear declined. contrary to previous studies, we found no or only small positive predictions by confidence in authorities, knowledge about the outbreak, and perceived individual risk, while all of those variables were rather high. these findings provide guidance for health communications or interventions targeting the adoption of health-protective behaviors in order to diminish the spread of covid- . on the th of january , the world health organization (who) declared the outbreak of a new coronavirus type (sars-cov- ) a public health emergency of international concern. while first cases of covid- , caused by this virus, were reported in the chinese city of wuhan at the end of december , by the end of march the virus had spread to all populated continents, resulting in exponential growth and more than . recorded infections and . fatalities worldwide. at that time, covid- had already significantly impacted physical and psychological health in many countries, with consequences for many individuals' daily lives and economic situations. increasing evidence about covid- suggests that adopting widespread public behavior change can have strong influences on controlling the virus' spread and limiting its harmful consequences on physical health and healthcare systems (ferguson et al., ; li et al., ) . some of these changes may be enforced by states (e.g., closure of schools), while others may be advised but not strictly enforced (e.g., reduction of group size in public), and others may be advised but outside of a state's control (e.g., hand washing in private). experiences from previous disease outbreaks such as ebola, sars, and the swine flu suggests that psychological factors including attitudes and affective reactions have a significant impact on whether individuals adopt health protective behavior or not (e.g., tang and wong, ; bish and michie, ; bults et al., ) . facilitating such behavior change during an outbreak is an important task of applied psychology during the covid- outbreak (lunn et al., ; van bavel et al., ) . in the current study, we explore what demographic and psychological variables predicted the adoption and engagement in health-protective behavior and how attitudes and self-reported behaviors changed over the course of a period of days during the covid- outbreak in norway. norway represents an interesting case as it featured the second highest rate of confirmed cases per capita (after italy) at the beginning of data collection ( th march), while having europe's third lowest population density. four weeks after the closing of schools and beginning of our data collection, norway had managed to reverse the growth of hospitalizations due to covid- . our data are collected during this period. while our data are cross-sectional rather than longitudinal, they allow the description of a social change process, in addition to exploring correlates of individual behavior. protective behavior in a pandemic can be categorized broadly into three types: preventive, avoidant, and management behavior. preventive behavior includes mainly increase in hygiene (e.g., handwashing), avoidant behavior refers mainly to physical distancing , and management includes taking medication and seeking help from health professionals and use of help lines. an important question to curb infections is, what individual factors predict this kind of behavior. bish and michie ( ) reviewed the literature on this following the sars crisis. they particularly focused on reported associations between demographic factors, attitudes, and behavioral measures (reported, intended, or actual behavior) . most reviewed studies were carried out in the middle of actual outbreaks, mostly of influenza and the sars coronavirus (sars-cov). the review found that preventive and avoidant behavior was predicted by a few demographic factors. these behaviors were more common among women, older people, and people indicating a higher education level (cf. ibuka et al., ; agüero et al., ; tooher et al., ; moran and del valle, ; zettler et al., ) . more recent evidence has also identified household size as a crucial variable. people living in larger households seem more likely to take precautions (ibuka et al., ) , presumably out of increased fear of getting infected or out of increased sense of responsibility for others, or both. the driving factor may be the presence of school-aged children (agüero et al., ; for contradicting findings, see bults et al., ) . preventive and avoidant behavior were also related to psychological factors. in particular, they were found to increase with perceived susceptibility to the disease (i.e., perceived likelihood of contracting the virus) and perceived severity of symptoms increase (tang and wong, ; agüero et al., ; tooher et al., ; gershon et al., ; webster et al., ) . in a spanish sample, the adoption of preventive measures during an influenza outbreak was increased by perceived effectiveness of these behaviors in reducing the risk of infection (agüero et al., ; see also tang and wong, ) . these observations are in line with classic and modern versions of expectancy-value theories, where expectancy equals susceptibility and severity equals value. for instance, the theory of planned behavior explains behavior as deriving from intentions that are influenced by attitudes, perceived social norms, and perceived behavioral control or effectiveness of the behavior (ajzen, ) . risk and severity may mediate effects of demographic variables, especially for gender. pandemics highlight the interdependence among individuals, and citizens' relations to their government. bish and michie ( , p. ) conclude from their review "that having a high level of trust in authorities and satisfaction with the communications received about the disease is associated with compliance with preventive, avoidant, and management behaviors." evidence from actual outbreaks confirms this bults et al., ) . it seems that little is known on how crucial psychological variables develop during the course of an epidemic. information on behavioral change over time is important for modeling a pandemic's course, and providing appropriate health messaging over time (poletti et al., ; collinson et al., ) . over the course of the first wave of the influenza (h n ) epidemic in hong kong, knowledge on modes of transmission did not improve, the adoption of avoidant behavior did not change, and, surprisingly, physical distancing declined, suggesting that changes might sometimes be counterintuitive . this may be due to the ongoing nature of the threat, the requirement to consistently engage in sometimes complex and unpleasant behaviors over a long period of time, and information or media fatigue resulting in reduced behavioral engagement. during the h n outbreak in the netherlands, perceived severity and anxiety decreased over time in line with better estimates of fatality, but also in line with claims that citizens can be fatigued by media reports (collinson et al., ) . it thus seems important to observe the time course of the involved psychological variables. wise et al. ( ) surveyed us-american participants between / / and / / , focusing on perceived risk from the virus and propensity to engage in protective behaviors. their sample (recruited through prolific.co) had roughly equal numbers of women and men and a median age of , skewing young. participants saw a medium risk of getting infected themselves ( %), which rose during the time of the sampling. participants reported that they washed their hands more and stayed at home more than usual, and this also increased during the sampling period. notably, they were able to reassess a subsample of participants, once at the beginning and once at the end of the sampling period, and confirmed that these changes also occurred within participants. self-reported increased hand-washing and physical distancing were predicted by perceived likelihood of becoming infected, but not severity of illness. to a lesser extent, perceived impact from global consequences also predicted both behaviors. wise et al. ( ) used multiple regressions with different risk perceptions as simultaneous predictors for these analyses and controlled for age. the other predictors (e.g., likelihood of infecting somebody else) did not predict behavior above risk to self, and neither did age. wise et al. ( ) also identified a subgroup in their sample that perceived low risk and disengaged from information seeking. in a non-representative sample of respondents from cities in china during the initial phase of the pandemic, about one third reported moderate to severe anxiety. interestingly, precautionary measures (e.g., hand hygiene, wearing a mask) were associated with lower levels of stress and anxiety, suggesting successful coping and belief in the behavior's effectiveness (wang et al., ) . in a small, mostly british, community sample (n = ) collected between march th and th, experiencing fear was the only positive and stable predictor of health-protective behavior (harper et al., ) . sampling us adolescents from the th to the nd of march, health-protective behavior including physical distancing and hand washing was positively predicted by perceived severity of the outbreak and social responsibility, as well as negatively predicted by self-interest (oosterhoff, ) . finally, a nearly identical version of the questionnaire employed in the current project was distributed among australian adults (n = ) between the nd and th of march (faasse and newby, ) . as the number of cases was considerably low in australia at that time (< ), the authors observed low prevalence of physical distancing behavior but rather high engagement with hygiene behavior. further, in the study engagement in health-protective behavior was positively predicted by the amount of media exposure, concern or worry about the outbreak, perceived severity of the outbreak, confidence in scientists and health professionals, and accurate knowledge about covid- . perceived likelihood of being infected was not a significant predictor of engagement with health behaviors. the first infected case in norway became known on february . the number of known infections grew at a relatively slow pace to until march , without much action by authorities or concern in the population. the total population of norway is . million. because authorities had been blindsided by an influx of infected people coming back from winter holidays in italian and austrian skiing locations, infections then suddenly increased to until march , and community spread was assumed. that day, on which we started data collection, was tumultuous: the first death was registered. because norway lacked testing capacity, a change in testing criteria was announced, prioritizing severely sick people and health personnel rather than travelers. mildly and moderately ill people did not have access to testing throughout the sampling period. also on march , the norwegian institute of public health (folkehelseinstitutet, fhi) published a report predicting that between and % of the norwegian population would be infected in the first wave, which was expected to take up to year (folkehelseinstiuttet, ). that report was widely publicized. finally, on the same day the government announced comprehensive measures to fight the virus, most notably shutting down schools and kindergartens, training facilities, and all cultural events. increased stocking up on food and supplies lead to empty shelves in some grocery shops, which was documented on social media. on march , it was reported that many norwegians left cities toward holiday homes in remote locations, which led to a rebuke by the authorities due to risk of spreading the virus. travel by foreigners without residence permits to norway via plane or boat was shut down march . the same day, in an extraordinary announcement, the norwegian king asked people to stand together and follow the authorities' advice. on march , fhi published a general call for increased physical distancing, and rules about quarantine, assemblies, and visiting cabins started being enforced with fines and short prison sentences. on the th, the national tv channel nrk aired a debate in which a medical doctor argued that norway should go into total isolation and that fhi was too lax. this was seen as controversial, praised by some, but criticized by many others. the number of hospitalizations passed on march , with people dead. three representative data sets are available with norwegian samples that help to anchor our data. saetrevik ( ) reported data from a representative sample of more than norwegians between march and march . respondents thought the average norwegian was likely to be infected by the coronavirus ( % of the panel said "somewhat high" or "very high"), while fewer thought that this would happen to themselves. quite few ( %) believed that they were at risk of becoming seriously ill themselves. kantar.no (gallup) conducted web interviews with representative samples n = and n = , on march - and march - , respectively, thus at the beginning and end of our first week of data collection (kantar, a,b) . on march / , the vast majority (> %) said that they had high or very high confidence that the health authorities would take the necessary measures to handle the situation in the best possible way, and that they provided accurate information on the situation. both numbers had increased compared to the week before. less than half, % (up from a week earlier), expected that they would likely or very likely be infected (up by % during the last week), while % said that was unlikely or very unlikely. a large group, %, was unsure, saying it was neither likely nor unlikely. answers judging infection as likely or very likely were more frequent than average among inhabitants of oslo and people younger than , but less frequent among people older than (only %). the same age effect was reported by saetrevik ( ) . when asked about behavioral changes in the last days, more than half and up to % reported increased hygiene behavior, reduced social contact, and increased purchasing of goods. from march - to march - , the number of people who were worried or very worried about the consequences for themselves or their families (the question did not specify what kind of consequences) increased by - %. opinion.no conducted a daily poll of norwegians from march to march (opinion, ) . n varied between and (gaute aas askheim, , march , , personal communication). on every day of that period, more than % of polled individuals expressed confidence in the measures taken by the authorities and trust in the information given by them to the public; confidence actually increased from % on march - % on march , and then fell again slightly. in the current project we investigated the influence of psychological and demographic variables in predicting healthprotective behavior in a norwegian sample. simultaneously, we focused on exploring the trajectories and developments of reported behavior, attitudes, and affective reactions during a -day period during the outbreak of covid- . we focused mainly on two aspects of protective behavior: preventive and avoidance behavior (bish and michie, ) . we did not focus on management behaviors, such as taking medicine or seeing healthprofessional, as no medication was available at the time of data collection and the main focus was on minimizing transmission and rapid dissemination by flattening the curve through hygiene practices and physical distancing (ferguson et al., ) . note that our sampling strategy primarily reached participants who were already engaged in discussing topics related to covid- , and are presumably more concerned than average. we were thus less likely to sample a lot of participants who viewed the risk as low and were disengaged from seeking information on covid- . our data are thus by no means representative. absolute means should be interpreted as being at the upper end of the real distribution. our analyses focus on relations between variables, which we assume to be generalizable to the larger population. also note that our data are not longitudinal, and we cannot draw causal conclusions. we nevertheless use the term prediction to describe the results of regression analyses for ease of phrasing. our analysis strategy in identifying important variables predicting engagement in health-protective behavior was twofold. first, we focused on a theory-driven strategy based on reviews and previous studies relating to health epidemics. second, we employed an exploratory data-driven machine learning approach in order to classify important variables. based on reviews concerning factors predicting behavior during pandemics and recent research (e.g., wise et al., ) , we derived the following hypotheses for the first strategy: (i) engagement in health-protective behavior was expected to be predicted by gender, education level, age, and household size. women, individuals with higher education level, older individuals, as well as those from larger households were expected to have more engagement in health-protective behavior. (ii) we expected that effects in i were mediated by own perceived risk (likelihood and severity; for gender, education level, and age) or by perceived risk of close others (likelihood and severity; for household size). females, individuals with higher education or older age should show increased perceived risk, which in turn should be associated with higher reports in healthprotective behavior. similarly, larger household size should be associated with higher perceived risk for close others, which in turn should positively predict healthprotective behavior. (iii) increased confidence and trust in authorities should positively predict engagement in health-protective behavior. note that these hypotheses were generated while performing data collection and not completely a priori. this was mostly due to time constraints as we wanted to ensure data collection during early periods of covid- outbreak in norway. the current project was ethically approved by the internal review board of the university of oslo. all materials, raw data, and syntaxes are available at our project page: https://osf. io/crs n/. we recruited a total of participants residing in norway through social media (e.g., facebook, twitter) and email lists. data collection took place for days from the th of march to the th of march . between march and march , we ran a paid ad on facebook, selecting norwegian users older than as the target group. the ad reached . viewers ( % female according to facebook), of which clicked through to the survey. the post was shared times and reached over . facebook users. the researchers did not themselves share the study in their own networks. after the ad campaign on facebook ended, the survey was shared on the website of the department of psychology (psi) of the university of oslo (uio) and in the facebook feeds of both psi and uio. after excluding participants who failed an attention check or spent less than min taking the questionnaire, we arrived at a final sample size of ( females, males, non-binary or different identity, preferred not to say, missing). the majority of participants were between and years of age. median age for both male and female participants was between and . the majority of participants reported residing in oslo county (n = , . %), while the fewest participants were from nordland (n = , . %). similarly, the majority indicated residing in a large city (n = , . %), while the lowest amount came from a rural area (n = , . %). the majority of the sample indicated a high degree of school education, having earned a college degree ( . %), whereas a smaller proportion indicated their highest education as less than high school or high school graduate ( . %). an participants were able to take part in a raffle getting the chance of winning one out of vouchers at a value of nok. this served mainly to jumpstart the participation; we did not anticipate the large sample ultimately achieved. to participate in the voucher draw, participants were invited to enter their email in a separate follow-up survey that was not linked to the main dataset. https://osf.io/crs n/ the main procedure was based on a similar survey conducted in australia and the us (faasse and newby, ). after providing informed consent, we checked whether potential respondents were residing in norway. those who did not were thanked and the survey was terminated. we then collected information on participants' postcodes and the county they resided in. based on the postcode data, we identified the municipality participants resided in. using these data, we added the amount of covid- cases for that given municipality on the day the respondent completed the survey based on numbers provided by the norwegian institute of health [folkehelseinstitutt (fhi)] and made accessible by the newspaper vg . similarly, we added information on population density per municipality level based on data from the statistisk sentralbyrå. in order to assess the variety and amount of media exposure, we asked participants how much they had seen, read, or heard about covid- [from nothing at all ( ) to a lot ( )], how much they think they know about covid- [nothing at all ( ) to a lot ( )], and how closely they had been following news about the recent outbreak [from not at all ( ) to very closely ( )]. these three items were combined into a mean media exposure score (α = . ). afterward, we instructed respondents to check all possible sources through which they had been getting information about the covid- outbreak [including news media, social media, official government websites, family member(s), colleague(s) or friend(s), none of the above, and other]. similarly, we asked participants which out of several sources they trusted the most concerning the outbreak [my doctor, my local hospital, folkehelseinstitutt, (norwegian) media, who, norwegian government, state department of health, none of the above, other]. to further investigate respondent's confidence, we asked how much confidence they had in different sources: the norwegian government providing full and accurate information, the chinese government providing full and accurate information, and scientists and medical experts understanding the outbreak. all items were completed on a -point scale (not at all confident to very confident, and don't understand at all to understand very clearly). respondents were also asked about how confident they thought health authorities, and hospitals and medical services were able to manage the covid- outbreak [from not at all confident ( ) to very confident ( )]. the four items (excluding the item on the chinese government) were averaged into a confidence score (α = . ). the item focusing on the chinese government was excluded as we mainly intended to focus on confidence in norwegian health authorities. additional analyses including the item are presented in the supplementary materials. respondents were asked how concerned or worried they were about the covid- outbreak [not at all concerned ( ) to extremely concerned ( )]. participants indicated how likely they thought it would be that they themselves would get infected by covid- and also how likely they thought it would be that close others (family/friends) would get infected [not at all likely ( ) to extremely likely ( )]. similarly, we asked how much participants thought they could do to protect themselves [effectiveness of behavior, i can't do anything to protect myself ( ) to i can do a lot to protect myself ( )]. asking about perceived severity, participants reported how serious they thought their symptoms would be if they got infected, and what the worst possible outcome could be for a family member or close friend that got the virus [no symptoms ( ) to severe symptoms leading to death ( )]. then, we asked whether participants had already wondered at some point whether they were infected [not at all ( ) to very much so ( )]. finally, we asked respondents whether they thought that too much fuss was being made about the risks of covid- [strongly disagree ( ) to strongly agree ( )]. this item was used previously to tap skepticism about warnings in public health crises (rubin et al., ) . affective reactions were captured with several items. participants reported whether they felt fearful, frightened, anxious, optimistic, encouraged, hopeful, relaxed, furious, outraged, depressed, and sad [strongly disagree ( ) to strongly agree ( )] . we averaged the first three items to create a fear score (α = . ), items four to six to create a hope score (α = . ), items eight and nine to create an anger score (α = . ), and the last two items to create a sadness score (α = . ). we included items on specific basic negative emotions (ekman, ; ahorsu et al., ) and futureoriented positive emotions (fredrickson, ) that we expected to occur commonly in response to health epidemics (kleinberg et al., ; though see fiske, for a critique of this approach). in order to test participant's knowledge about the covid- outbreak, we first asked them to judge whether statements about the virus and disease were true (answer alternatives true, false, and unsure). we then asked participants to indicate what the most common symptoms of covid- were from a list of seven possible symptoms (fever, cough, sore throat, shortness of breath, nausea, vomiting, diarrhea) . afterward, respondents were prompted to indicate how covid- could spread, according to their knowledge (by air, by water, by mosquitoes, droplets spread through coughing or sneezing, touching surfaces that have been recently touched by someone who is sick, and touching or shaking hands with a person who is sick). the symptoms and transmission items used the same scale (yes, no, unsure) . because the employment of face masks has been a popular debate, we asked who should be wearing a face mask to minimize transmission (healthy people -to prevent infection, sick people -to stop them spreading the virus, everyone, and no one) . finally, we asked participants to estimate what percentage of people who had been infected with covid- had died from the in a first version of the questionnaire the scale went from "strongly agree ( )" to "strongly agree ( )" due to a clerical error. this was corrected immediately after the first approximately responses. at the time the survey was started, symptoms like nausea or diarrhea were not regarded as typical symptoms of covid- . however, as the outbreak proceeded the who added these to the list of possible symptoms (https://www.who.int/health-topics/coronavirus#tab=tab_ ). thus, these responses were not part of the final knowledge score. during the time the study was conducted there was a general recommendation that face masks should only be worn by infected people. this recommendation changed after the project was terminated, highlighting the usefulness of face masks also for healthy people. virus. respondents were able to provide an answer between and %. out of all correct answers we constructed a knowledge sum score (ranging from to ). for the last item, we took the range between and % as a correct answer, as official indications had been varying somewhat during the period the study was conducted. we then asked respondents to indicate whether they performed different health-protective behaviors in response to the covid- outbreak during the past weeks. these behaviors consisted of physical distancing behavior ( items, e.g., reduced or avoided going to work or university), hygiene behavior ( items, e.g., used sanitizing hand gel to clean your hands more often than usual), prosocial behavior ( items, e.g., helped buying groceries and supplies for people who are in quarantine), and two additional items (e.g., worn a face mask when going out in public) . responses could be made using four alternatives (yes, no, unsure, not applicable). for each type of behavior, we computed a sum score based on whether the behavior was performed or not. in addition, we computed an overall health/communal-protective behavior sum score based on the physical distancing, hygiene, and prosocial items (summing up all items). finally, respondents were able to write down whether they did anything else in response to the covid- outbreak. we collected several items on demographic information and health-related behavior and characteristics. first, participants were asked how likely they would be to get vaccinated in case an effective vaccine for covid- had been developed [would definitely get the vaccine ( ) to would definitely not get the vaccine ( )]. we then asked to what age groups respondents belonged to (e.g., - , - , - , - , . . ., +) and with what gender they identified (male, female, non-binary, different identity, prefer not to say). participants then indicated how many children they had (none, , , more than ) and the level of their highest education (less than high school, high school graduate, some college, ba degree, ma degree, professional degree, doctorate). we then asked what type of community they lived in (large city, suburb, small city/town, rural area) and how many people (including them) lived in their household (from to or more). participants then completed some items about their health status, including how they would rate their health in general [poor ( ) to excellent ( )], whether they had a flu vaccine within the last year (yes, no, unsure), whether they had been in an affected area with high transmission within the past weeks, whether they had been in close contact with people who are suspected to be infected, whether they had experienced any covid- symptoms, whether close others experienced any symptoms (on all yes, no, unsure), whether they had any chronic health problems that increased their risk, and whether close others had any chronic health problems (both items yes, no, unsure, prefer not to say). finally, participants were thanked and provided with several links to websites from official sources (who, ecdc, fhi) that provided information about the covid- outbreak. when analyzing data using null hypothesis significance testing (nhst), we set our alpha level at p < . . this decision was based on the fact that we employed a considerably large dataset and our findings might have important healthpsychological implications (see lakens et al., ) . as even small effects will reach statistical significance given large samples, we primarily focus on interpreting effect sizes and their direction and magnitude. as said above, our analytic strategy was twofold: first a theorydriven step and second an exploratory data-driven machine learning step. for the theory-driven step, we used regular linear regression. the mediation models also tested in this first step employed a bootstrapping method (n = ) to calculate confidence intervals around the indirect effect. for the data-driven step, the goal was to classify what variables predicted health-protective behavior out of all predictors we had available in a bottom-up fashion. to do so, we combined supervised machine learning with a partially confirmatory approach (split-half validation) as employed in previous research dealing with large numbers of predictors (e.g., ijzerman et al., ). as a supervised machine learning technique, we used conditional random forests, a bootstrap-like algorithm that assesses the relative contribution of each variable on the dependent variable (the signal), therefore being considered a supervised approach (breiman, ) . as the name suggests, the algorithm "plants a forest consisting of several trees" that represent the importance of a predictor randomly sampled from the dataset. this procedure is based on out of bag estimates, also called bagging, that features repeated sampling from the original data. in essence, the technique bootstraps several nonparametric regression models and summarizes the importance of each predictor by aggregating and weighting the predictors into a parsimonious set (see breiman, ; ijzerman et al., ; yarkoni and westfall, ) . as summarized by ijzerman et al. ( ) , employing a supervised machine learning algorithm has several advantages in comparison to classical regression models, and especially using them for exploratory analyses. the algorithm is naive to non-linear relationships, does not assume the direction of a relationship, has less problems with multicollinearity, and has the advantage of assessing each predictors individual role, but also its multivariate interactions with other variables (strobl et al., ) . for our analyses we employed r (version . . ) and several packages including: dplyr (wickham and françois, ) , car (fox et al., ) , sjmisc (lüdecke et al., ) , tidyr (wickham and henry, ) , and stringr (wickham, ) for data recode and wrangling routines, ggpubr (kassambara, ) , sp (pebesma et al., ) , viridis (garnier et al., ) , cowplot (wilke, ) , fhidata (white, ) for plotting, apatables (stanley, ) for tables, lavaan (rosseel et al., ) for mediation analyses, and randomforest (breiman et al., ) , party (hothorn et al., ) , tree (ripley, ) , lattice (sarkar, ) for the machine learning analyses. considering respondents' information sources, the majority indicated that they received their information about the covid- outbreak from several different sources -on average, participants indicated m = . different sources (sd = . ). a total of % reported news media as an information source, with a smaller number using official government websites ( %) or social media ( %). less than half of all participants indicated that they used colleagues ( %) or family members ( %) as an information source. no participant reported relying on no source at all. the majority of participants expressed trust in advice and information from the norwegian health institute (fhi; %). this trust was much smaller for the norwegian department of health ( %), the norwegian government in general ( %), and the european centre for disease prevention and control (ecdc; %). a total of % of respondents reported trusting (norwegian) media, and the overall lowest trust was indicated for one's doctor or general practitioner ( %), and one's local hospital ( %). respondents rated their own perceived likelihood of catching covid- on average somewhat over the midpoint of the point scale (m = . , sd = . ). assuming they would get infected, the majority predicted to have mild or moderate symptoms ( . %), while a small proportion reported to expect no ( . %) or more severe symptoms ( . %). participants saw it as even more likely that someone from their family or a close friend would get infected (m = . , sd = . ). when imagining the worst possible outcome for a family member or friend who would get infected, the majority ( . %) also foresaw potentially worse outcomes including severe symptoms or severe symptoms leading to hospitalization or death. participants reported that they had already wondered whether they were infected somewhat lower than the midpoint of the scale (m = . , sd = . ). finally, on average respondents tended to disagree that too much fuss was being made about the risks of the covid- outbreak (m = . , sd = . on a - scale), with only around . % tending to agree or strongly agree. on average, participants indicated that they were moderately concerned or worried about the outbreak (m = . , sd = . ), with . % being very or extremely concerned. similarly, on average respondents reported to show the highest levels of fear (m = . , sd = . ), followed by sadness (m = . , sd = . ), hope (m = . , sd = . ), and anger (m = . , sd = . ). considering behavior responses, the majority of respondents reported that they had reduced or avoided going to public events ( %), taking public transport ( %) or going to shops ( %). similarly, a high percentage of participants disclosed that they had washed their hands more often ( %) and more thoroughly ( %), tried to stay away more than m from others coughing or sneezing ( %), as well as tried to sneeze into the crook of their arm ( %). for prosocial behavior, a majority of respondents indicated that they talked to others and tried reminding them of protective behavior ( %). a rather low occurrence of participants reported that they had avoided chinese restaurants or neighborhoods specifically ( %) or donated money to charity focusing on combating the covid- outbreak ( %). an overview of all behaviors is provided in figure . in order to classify important variables predicting engagement in health-protective behavior we employed two different strategies: a highly confirmatory theory-driven strategy based on reviews and previous studies on the covid- outbreak, and a highly exploratory data-driven approach using a supervised machine learning procedure combined with split-half validation. in order to test hypothesis i, we conducted a linear regression using the health-protective behavior sum score as the outcome and gender, education, age, and household size as predictors (see table and figure for results). as predicted, reporting one's gender as female, indicating a higher education level, as well as a bigger household was associated with significantly more engagement in health-protective behavior. contrary to our prediction, age showed a negative association with healthprotective behavior. however, when inspecting the relationship between age and engagement in health-protective behavior, we observed a non-linear relationship showing first an increase in behavior with increasing age that leveled off at around - years of age ( figure b) . notably, our sample included few individuals over the age of , suggesting that these findings should be interpreted with caution. similarly, when repeating the model with time as a covariate the age effect was not significant, while the other predictors still showed positive effects (see supplementary material). to test hypothesis iii, we regressed the confidence score (mean score based on ratings of confidence in norwegian government, scientists, health authorities, and medical services) on engagement in health-protective behavior (table and figure d ). contrary to our prediction, we observed a small negative association. the more confidence respondents expressed in authorities, the less health-protective behavior they reported. we tested four mediation models. the tests are documented in detail in the supplementary material (supplementary figure s ) . in all models, health-protective behavior was the dependent variable. the first three models tested separately whether the effects of gender, age, and education level, respectively, were mediated by two mediators, likelihood and severity of perceived risk. the fourth model tested whether the effect of household size on health-protective behavior was mediated by likelihood and severity of risk to close others. in short, we found some evidence for mediation of the demographic variables gender, age and education level through likelihood and severity of risk, confirming classic notions of expectancy × value theories. this was especially true for age and education, and the mediation through likelihood. however, all observed mediations were small and partial, and the patterns varied between the different models. this suggests that the demographic variables impact behavior through other channels that were not captured by our measured constructs. we thus do not go into further detail on these here; see the supplementary material for further information. following the strategy laid out above, we employed a data driven approach to identify the strongest predictors that parsimoniously predict health-protective behavior from all predictors we had available. for this purpose, we first split the dataset randomly in half and performed conditional random forests on one half, the training dataset (n = ). for reproducibility, we actually performed the algorithm using two different seeds and two versions of the amount of variables sampled at each tree (mtry, the square root of the number of variables, or ). the spearman rank correlation among the replications was between . and gender was dummy coded ( = male; = female). a significant b-weight indicates the beta-weight and semi-partial correlation are also significant. b represents unstandardized regression weights. beta indicates the standardized regression weights. r represents the zero-order correlation. ll and ul indicate the lower and upper limits of a confidence interval, respectively. *indicates p < . . . and therefore considered as stable. according to this analysis of the training dataset, health-protective behavior was best predicted by (in order; see also supplementary figure s ): concern/worry, fear, household size, thinking that too much fuss is made, number of children, perceived effectiveness of behavior, media exposure, sadness, anger, age, relaxation, symptoms (close others), symptoms, perceived risk (likelihood), being to an area with a high number of cases, gender, contact to other individuals showing symptoms, community type, education level, perceived health, knowledge, perceived risk (severity), population density at municipality level. we observed no evidence that perceived risk (severity) of close others, feeling hope, perceived risk (likelihood) of close others, amount of media sources consumed, actual number of cases per municipality, confidence in authorities and scientists, or taking a flu vaccine within the last year predicted better than random noise. we then continued to run a regression analysis on healthprotective behavior using the second half of the data, the test dataset (n = ) with the predictors found in training dataset. this was done to reduce random noise from the first step. an overview of the results is provided in table . healthprotective behavior was positively and significantly (at the . level) predicted by household size, number of children, perceived effectiveness of the behavior, and media exposure, when controlling for all other variables. similarly, we observed that thinking that people made a fuss about the outbreak and reported age showed significant negative predictions when controlling for the other predictors. as mentioned earlier, the negative finding concerning age should be interpreted with caution since we sampled a small number of older adults exceeding years of age and considering the relationship between age and health-protective behavior showed a non-linear association, resembling a reverse u-shaped curve. while other variables such as concern or fear showed the strongest variable importance in the first step, they did not emerge as significant predictors from the second step. however, they still showed a similar positive effect as for example media exposure and medium zero-order correlations. the same was true for symptoms and relaxation, with the latter showing a negative prediction. we repeated the procedure of training machine learning and test using linear regression for hygiene and physical distancing behavior separately. results differed only minimally and can be found in the supplementary materials. for physical distancing, perceived effectiveness of the behavior and respondent's symptoms had a stronger variable importance. for hygiene behavior, the amount of media sources they were exposed to and whether respondents received a flu vaccine within the last year were more important. physical distancing was positively and significantly predicted by household size, number of children, whether the respondent experienced symptoms, and perceived effectiveness of one's own behavior. on the other hand, thinking that people made a fuss and age predicted physical distancing negatively. for hygiene behavior, concern/worry, fear, and media exposure showed a significant positive association when controlling for the other variables. thinking that 'too much fuss' was being made about the risk of covid- predicted hygiene behavior negatively. in general, it seemed that being surrounded with more people, and regarding staying away from others as effective, predicted physical distancing, whereas emotional reactions and media exposure were more important for in engaging in hygiene behavior. finally, we explored the development of behaviors, attitudes, and affective reactions over time. we focused specifically on physical distancing and hygiene behavior (behavior), confidence in authorities, perceived risk likelihood, perceived risk severity (attitudes), and concern/worry, fear, and hope (affective reactions). we regressed each variable on day and day squared. we excluded dates that included less than participants, which was true for the beginning (march , n = ) and end of data collection (march , n = ) . the first day of the time series was thus coded as . thus, we focused on data points per variable (n = ). notably, we did not employ a repeated measurement design. we can thus only model changes between participants, but not within, and changes observed over time could be due partially to changes in the sample composition. in order to control for changes in demographics per day we computed four logistic regression models regressing age, gender, education level, and household size on day and day squared. we only observed statistically significant effects for age showing a negative linear effect (b = − . , se = . ) and a positive quadratic effect (b = . , se = . ), suggesting that the sample in general became younger over time, but then increased in age at the end of the sampling period. as previous analyses suggested that age predicted health-protective behavior and other variables, we added age as a covariate to all models in order to control for it. results are provided in table and time series can be found in figure . for behavior, we observed that physical distancing showed a significant positive linear trend. overall, engagement in physical distancing behavior increased during the days of data collection. on the other hand, hygiene behavior showed no significant linear or quadratic effect. instead, it showed a small decrease during the first days, but remained rather stable. a significant b-weight indicates the beta-weight are also significant. b represents unstandardized regression weights. beta indicates the standardized regression weights. r represents the zero-order correlation. ll and ul indicate the lower and upper limits of a confidence interval, respectively. *indicates p < . . considering attitudes, we observed that confidence in authorities slightly increased during the testing period, though this effect was not statistically significant. perceived likelihood of catching covid- showed both a significant positive linear trend and a significant negative quadratic trend, first increasing, but later showing a small decrease. severity of the disease combined a significant negative linear and a positive quadratic trend, first decreasing and then increasing. taken together, it seems that the more likely catching covid- was reported to be, the less severe respondents estimated it to be over time. finally, experiencing concern or worry showed a significant negative linear effect decreasing over time. at the same time, we also observed a significant positive quadratic trend, suggesting that concern increased at the end of the testing period. experiencing fear showed a small decrease over time. for experiencing hope, we did not find any significant linear or quadratic trends. we sampled over . norwegian participants in the first weeks after schools were closed and many employees were sent to work from home, at the beginning of the covid- outbreak in norway. we observed self-reported health-protective behavior and emotions in real time, while numbers of registered infections rose from to , the number of hospitalized patients rose from to , and the number of deceased patients rose from to . although policy setting may be the main determinant of behavior, psychological factors play an important role in responses to health crises as they modulate how people adopt the guidelines. in the present project we focused on what factors are correlated to engagement in two variants of protective behavior: preventive, such as hygiene behavior, and avoidance, including physical distancing. we employed both a theory-and a data-driven approach, and we explored how attitudes, behavior, and affective reactions changed over the course of the -day sampling period. to protect us from overinterpreting spurious effects, which would be costly in the current situation, we set our significance level to p < . . in our sample, main news sources were news media, government websites, and social media in that order, more than colleagues and family members. when indicating whom they trusted most, participants mainly pointed to the norwegian institute of health (fhi), more so than other norwegian government sources or european sources. one's own doctor and hospital was rarely reported as the most trusted source. confidence was high that authorities, including the norwegian government, scientists, health professionals, and medical services, were able to manage the outbreak. despite the increase in infected cases, we observed that confidence stayed stable and even slightly (but not significantly) increased over the time of days. respondents expected that they too would likely get infected, with an average above the midpoint on our likelihood rating scale ( %). this average was at the upper end of fhi's prediction for the general population from / , and higher than the number in wise et al.'s ( ) sample (m = ) and the representative sample analyzed by saetrevik ( ) , suggesting that due to our sampling strategy our participants might be more concerned and engaged with the topic than the norwegian population on average. at the same time, perceived severity was predominantly rated with mild or moderate symptoms. ratings were higher for the perceived likelihood of close others catching the disease ( %) and similarly, a high proportion of respondents ( %) could imagine that someone from their family would show severe symptoms or even die when imagining the worst case. this was also in line with the observations made in parallel by saetrevik ( ) . self-reported behavior was very much in line with policies asking for (but not mandating by law) physical distancing and protective hygienic behavior. even behavior that is sometimes difficult to avoid like taking public transport and going to shops was reported as being reduced or avoided by more than % of the sample. more than % reported other-protective behavior in the form of reminding other individuals of proper behavior or not visiting older individuals. fewer people actively helped others by for instance buying groceries or even giving money to charities combating covid- . only a small minority reported irrational avoidant behavior (e.g., avoiding chinese restaurantsgiven that the main group bringing infections into norway were norwegians coming from winter holidays in the alps rather than travelers associated with china). in line with previous findings during other pandemics and also covid- (bish and michie, ; harper et al., ; wise et al., ) , the elevated level of appropriate protective and avoidant behavior was predicted by demographic variables: female participants, higher education levels, and larger household sizes. to some extent, these effects were mediated by elevated perceptions of likelihood and severity of the disease for self and others, but these mediations did not explain much variance and indirect effects were considerably small. these models may underestimate the true effect, however, because expectations and behavior changed over the course of the sampling period. there might be other factors that explain this pattern of results. for instance, recent findings show that compassion and empathy play an important role for the engagement in physical distancing during the covid- outbreak (pfattheicher et al., ) and such reactions have been observed to a higher degree in women (christov-moore et al., ) . previous studies also reported that older age predicted more engagement in health-protective behavior. we failed to find a clear replication in the current sample. in fact, our regression analyses point in the direction that older age is associated with less adoption of health-protective behavior. when exploring this association in more detail, we observed four important boundaries. first, we observed a non-linear relationship between age and protective behavior, suggesting that engagement in health-protective behavior increased with age as predicted by previous literature, but then leveled off at around the age of - and decreased with older age. second, our sample included only a few participants above the age of . their estimates are therefore highly imprecise compared to younger respondents (that we sampled around times more often) and when excluding age groups with less than participants the relationship between age and protective behavior was reduced to near zero. third, the effect was reduced when controlling for time. fourth, when constructing the main outcome variable in a different way in order to account for the possibility that some behaviors from our list were not applicable for older adults (e.g., avoiding work) we observed a weaker effect (see supplementary material) . thus, given the composition of our sample we can be more certain that respondents at the age of engage in more protective behavior than respondents at the age of . however, whether engagement in health-protective behavior again decreases for individuals at the age of should be interpreted with caution. if this is indeed the case, this would represent an important finding as risk factors and susceptibility increase with age. we recommend testing this question with a representative sample. in a second step, we tested the influence of more than variables on health-protective behavior employing a supervised machine learning algorithm. we observed that higher engagement in health-protective behavior was associated with ( ) larger household size, ( ) more children, ( ) higher perceived effectiveness of the protective behavior, ( ) more media exposure, and ( ) reduced belief that 'too much fuss' was made about the outbreak (i.e., discrediting the severity and credibility of the crisis, rubin et al., ) above and beyond other factors such as knowledge, perceived risk, living in a municipality with a high amount of recorded cases or one's own perceived health. the simultaneous presence of demographic and psychological predictors indicates that the psychological mediators of the remaining demographic factors remain unclear. when considering preventive and avoidance behaviors separately, we observed that household size (i.e., being surrounded by more people) and regarding staying away from others as effective predicted physical distancing, whereas emotional reactions such as concern, worry, or fear and media exposure had a stronger importance in engaging in hygiene behavior. our findings replicate previous studies suggesting that high perceived effectiveness is important as a predictor of engaging in health-protective, and specifically avoidance behavior (ajzen and timko, ; agüero et al., ) . the importance of household size and the number of children, especially for the adoption of avoidance behavior, points to the possibility that individuals might feel more personally responsible for their co-habitants. literature on the effectiveness of health communications suggests that personal relevance represents an important factor for engaging in protective behavior, which is likely higher if more people within one's social proximity could be affected (ruiter et al., ) . similarly, household size is typically conflated with age showing an inverse u-shaped curve, which fits our observations concerning the association between age and protective behavior. in addition, individuals that need to care for others might show more empathy or compassion, thereby increasing engagement of avoidance behavior as a means of prosociality (pfattheicher et al., ) . on the other hand, engagement in preventive behavior such as hand washing or using hand sanitizing gel was associated less with social-contextual variables, but to a higher degree with felt concern, fear, or worry, as well as increased engagement with the topics. for both types of behaviors, we found that believing there is too much fuss made about the outbreak reduced it. this relation could have several reasons. wise et al. ( ) identified a subgroup that was disengaged from the news, unaware of risks, and not practicing recommended behavioral change. participants who indicated that "too much fuss was made" may have belonged to a similar subgroup. on the other hand, there might be a group of people who for some reason cannot change their behavior, and consequently adapt their attitudes to be consistent. in any case, if that group is large enough, it could counteract quarantine measures in communities. it thus seems important to follow up on this effect, again ideally with representative samples. contrary to our predictions, we observed that increased confidence in authorities reduced the adoption of healthprotective behaviors. similar findings were observed in the sister study of the current project with an australian sample (faasse and newby, ) . while confidence in governments, health professionals, and medical services has been reported as crucial for individuals to adopt behavioral change (bish and michie, ) , it is possible that overconfidence results in reckless behavior, as it is assumed that everything will be under control no matter what individual actions are performed. this finding points at a dilemma, as confidence in authorities is needed to establish protective behavior in the first place and reduce panicking or intense fear of the outbreak (asmundson and taylor, ) . health communications therefore need to highlight the importance of individuals actions as part of greater societal outcomes, and simultaneously communicate conviction in recommended measures and risk. during the -day sampling period, we observed a significant increase in avoidance behaviors. these changes could be explained by individual psychological factors such as increased personal relevance or concern, group behavior and attitudes (such as injunctive norms), or contextual factors. for instance, throughout norway schools and universities were closed on the th of march, creating a uniform behavior change. similarly, most public events such as sports or concerts were canceled. it is not possible for the present data to show whether changes in avoidance behavior were based on psychological factors or situational constraints. interestingly, we observed little change in hygiene behavior during the sampling period. it could be possible that hygiene behavior was already quite high at the beginning of data collection: over % indicated engaging in more thorough hand washing behavior. on the other hand, increased self-isolation through avoidance behavior could have resulted in neglecting additional preventive behavior. in contrast to previous studies on responses to pandemics or specifically covid- , we failed to find strong associations between perceived risk or knowledge and engagement in protective behavior. while perceived likelihood and severity showed positive relations with health-protective behavior, these effects were considerably small and smaller than factors such as the number of children or experienced concern. similarly, knowledge showed no or even a negative relationship with engagement in protective behavior. as knowledge and media exposure were on average quite high, it could be that we simply did not have enough variation in the sample to detect a larger effect. nevertheless, the implication seems to be that motivating people to practice protective behavior works best by emphasizing that it is effective, rather than by exaggerating risks of not engaging in it. the present findings mostly replicate an earlier study using nearly identical methods in an australian sample in an earlier stage of the pandemic (faasse and newby, ) . similar to this study, we found positive relations to media exposure, concern and worry, as well as effectiveness of behavior. in addition, we also replicated the finding that confidence in authorities and believing that too much fuss was made resulted in less healthprotective behavior. our observed effect sizes ranged from zero-order correlations (r) of . between concern/worry and health-protective behavior to standardized regression coefficients (beta) of . for the prediction by media exposure when controlling for the other variables, or less. the estimated effect sizes are in line with published literature focusing on attitude-behavior relationships (bosco et al., ) and can be considered as small to medium effects. similarly, our effects are comparable to previous research exploring predictors of health-protective behavior during the covid- outbreak (faasse and newby, ; harper et al., ; wise et al., ) . it would have been helpful to define a smallest effect size of interest in order to be able to conclude when an effect is absent by for example applying equivalence testing (lakens, ) . however, given the exponential nature of the growth of infections it is difficult to decide on a cut-off regarding which effects might not be of practical importance anymore. while standardized regression or correlation coefficients of . might be typically considered as too small to be of practical importance, they could still be informative in the current context. answers to that can only come from models that integrate behavior and epidemiological effects (e.g., poletti et al., ) . in general, we note that our effects were on average comparable small. our study has several limitations that should be considered when interpreting the findings. first, although large, our sample was not collected in a way that makes it representative. women, younger people, and individuals with a higher education level are overrepresented; this should be taken into account when interpreting the presented findings. nevertheless, our total sample size was large enough that we trust our estimates for male participants. notably, percentage of people expecting to become infected, confidence in the government to handle the crisis, and percentage of those worried about family members are similar to numbers found in two representative survey studies among the norwegian population (kantar, a,b) , suggesting that our sample might be quite similar to the norwegian population at large. nevertheless, our study provides a snapshot of a -day period, focusing on a non-representative sample representing a specific culture with all its societal and normative implications, as well as certain healthcare systems and authorities that are hardly generalizable to different countries, healthcare systems, or timepoints in a pandemic. second, although time is a meaningful variable in the days window that we observed, our sample is cross-sectional, not longitudinal. changes over time can thus be caused by various confounding variables and simply be due to sampling variation, despite our efforts to control for that. strong inferences about intra-individual change need repeated measures in a longitudinal design, which we do not have (borsboom et al., ; fisher et al., ) . third, we did not pre-register our research methods and analysis plan. indeed, we largely adopted an existing instrument and developed the literature review and hypothesis in parallel to data collection. the main research scope of the present project was exploratory in nature and we did our best to increase the reliability of our findings by conducting a split-half validation method (ijzerman et al., ) . due to the exploratory approach, we included several variables that have been found to predict protective behavior in past literature or were deemed important. of course, it is possible that we failed to include important variables associated with health-protective outcomes, such as compassion or empathy (pfattheicher et al., ) . fourth, the measurement of some of the included variables, especially our outcome variable, could be improved. in the current project we assessed protective behavior using a dichotomous format (answer alternatives yes/no, we also added unsure, and not applicable). a likert-scale type measurement might be superior in capturing the whole breadth of responses in the outcome variable. at the moment a respondent will answer yes if she avoided specific situations once or several times within the last weeks. using more response options would allow us to differentiate among such responses. similarly, we focused on self-report of behavior, not actual behavior and there might be a gap between reported and actual health-protective behavior. however, recent research focusing on gps movement data in the us during the covid- outbreak suggests that self-report data might be used as a proxy for actual behavior (gollwitzer et al., ) . our measures of protective and avoidant behavior were much more comprehensive than our measure of other-supporting behavior. as the crisis proceeds, various behaviors that support the community through donating food, equipment, and money, making masks, supporting each other through buying food, and taking care of children become important, and it is known that such communal behavior emerges in crises and can be stifled by authorities reacting the wrong way (solnit, ; drury et al., ) . future studies should place more emphasis on such measures. finally, we believe that our understanding of the motives behind protective and avoidant behavior is not ideal. unless one knows for sure whether oneself or another person is infected, most behavior serves both to protect oneself and others. for instance, the discussion about wearing non-clinical facial masks has moved from initial arguments that they are not providing total protection for the wearer to the insight that they do protect others if the wearer is infected -and if everybody protects everybody else, then everybody is protected. in our data, we are not able to tease apart motivation to protect the self and otherprotection motivation, either for close others or the community. again, this remains a crucial topic for future work. the present project provides a snapshot of individuals' attitudes, behavioral actions, and affective reactions during weeks following the covid- outbreak in norway. while our findings do not generalize to the whole norwegian population, nor to other countries with different courses of action responding to the outbreak or different healthcare systems, they provide important information on the nature of what psychological and demographic variables might influence health-protective behavior and how such variables change over time. the findings can provide insights and indications in order to improve healthcare communications: ( ) perceptions of effectiveness of protective behavior are important; they emerge as crucial especially when trying to predict physical distancing. they could be increased by tailoring communication strategies to various groups, emphasizing how different people can engage in effective preventive (hygienic) or avoidance (distancing) behavior. ( ) people differ, and these differences matter for the adoption of protective behavior: being female, household size, and number of children all seem to play a role. on one hand, these factors point to how early on in a crisis first changes can be reached quickly by targeting such response groups. on the other hand, this again shows that tailored messaging and targeted behavior change campaigns are indicated. ( ) physical distancing and hygiene seem to be driven by somewhat different factors: the former more by social variables and beliefs of effectiveness, the second more by emotional processes. again, campaigns targeting these complementary protections should be aware of that. ( ) in line with previous literature, there is a subset of the population that discredits severity and credibility of the crisis, indexed in our study as the belief that "too much fuss is being made" about this, which is in turn associated with less engagement in health-protective actions (cf. rubin et al., ) . it may be fruitful to model and investigate the potential impact such individuals can have on the spread of the disease, the reasons for their beliefs, and targeted ways to change their beliefs. finally, the present project highlights that although similar factors can be found across different countries or medical systems that seem to influence protective outcomes (e.g., harper et al., ; wise et al., ) , it is important to take the specific trajectories and developments in each country or healthcare systems into account to be able to successfully model and identify important variables predicting health-protective behavior (see maekelae et al., ) . the datasets presented in this study can be found in online repositories. the names of the repository/repositories and accession number(s) can be found in the article/ supplementary material. the studies involving human participants were reviewed and approved by internal review board, institute of psychology, university of oslo. the patients/participants provided their written informed consent to participate in this study. adoption of preventive measures during and after the influenza a (h n ) virus pandemic peak in spain the fear of covid- scale: development and initial validation the theory of planned behavior correspondence between health attitudes and behavior coronaphobia: fear and the -ncov outbreak demographic and attitudinal determinants of protective behaviours during a pandemic: a review the theoretical status of latent variables correlational effect size benchmarks random forests randomforest: breiman and cutler's random forests for classification and regression perceived risk, anxiety, and behavioural responses of the general public during the early phase of the influenza a (h n ) pandemic in the netherlands: results of three consecutive online surveys empathy: gender effects in brain and behavior the effects of media reports on disease spread and important public health measurements community psychological and behavioral responses through the first wave of the influenza a(h n ) pandemic in hong kong facilitating collective psychosocial resilience in the public in emergencies: twelve recommendations based on the social identity approach an argument for basic emotions public perceptions of covid- in australia: perceived risk, knowledge, health-protective behaviours, and vaccine intentions. medrxiv [preprint impact of non-pharmaceutical interventions (npis) to reduce covid- mortality and healthcare demand lack of group-toindividual generalizability is a threat to human subjects research the lexical fallacy in emotion research: mistaking vernacular words for psychological entities risikovurdering og respons i norge versjon . folkehelseinstiuttet. available online at car: companion to applied regression the role of positive emotions in positive psychology: the broaden-and-build theory of positive emotions viridis: default color maps from "matplotlib re: koronamonitor adherence to emergency public health measures for bioevents: review of us studies connecting self-reported social distancing to real-world behavior at the individual and us state level functional fear predicts public health compliance in the covid- pandemic party: a laboratory for recursive partytioning the dynamics of risk perceptions and precautionary behavior in response to (h n ) pandemic influenza the human penguin project: climate, social integration, and core body temperature what predicts stroop performance? a conditional random forest approach befolkningens holdninger til situasjonen med korona-smitte kantar koronabarometer befolkningens holdninger til situasjonen med koronasmitte ggpubr: "ggplot " based publication ready plots measuring emotions in the covid- real world worry dataset equivalence tests: a practical primer for t tests, correlations, and meta-analyses justify your alpha substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (sars-cov ) situational awareness and health protective responses to pandemic influenza a (h n hong kong: a cross-sectional study sjmisc: data and variable transformation functions using behavioral science to help fight the coronavirus a meta-analysis of the association between gender and protective behaviors in response to respiratory epidemics and pandemics perceived efficacy of actions during the early phase of the covid- outbreak psychological correlates of news monitoring, social distancing, disinfecting, and hoarding behaviors among us adolescents during the covid- pandemic slik er tilliten til myndighetene dag for dag sp: classes and methods for spatial data. r package version . - the emotional path to action: empathy promotes physical distancing during the covid- pandemic risk perception and effectiveness of uncoordinated behavioral responses in an emerging epidemic tree: classification and regression trees. r package version . - lavaan: latent variable analysis. r package version . - who is sceptical about emerging public health threats? results from national surveys in the united kingdom scary warnings and rational precautions: a review of the psychology of fear appeals lattice: multivariate data visualization with r a paradise built in hell: the extraordinary communities that arise in disaster apatables: create american psychological association (apa) style tables conditional variable importance for random forests realistic expectations and pro-social behavioral intentions to the early phase of the covid- pandemic in the norwegian population an outbreak of the severe acute respiratory syndrome: predictors of health behaviors and effect of community prevention measures in hong kong, china community knowledge, behaviours and attitudes about the h n influenza pandemic: a systematic review using social and behavioural science to support covid- pandemic response immediate psychological responses and associated factors during the initial stage of the coronavirus cisease (covid- ) epidemic among the general population in china how to improve adherence with quarantine: rapid review of the evidence. medrxiv fhidata: structural data for norway. r package version . . stringr: simple, consistent wrappers for common string operations dplyr: a grammar of data manipulation tidyr: tidy messy data cowplot: streamlined plot theme and plot annotations for "ggplot changes in risk perception and protective behavior during the first week of the covid- pandemic in the united states choosing prediction over explanation in psychology: lessons from machine learning individual differences in accepting personal restrictions to fight the covid- pandemic: results from a danish adult sample jg and kf devised the original method. jz, ts, and ah adapted the original instrument for norway, and ah translated it into norwegian. jz analyzed the data and wrote the first draft. all authors contributed to revisions. we thank bjørn saetrevik, alf børre kanten, gerit pfuhl, torleif halkjelsvik, Øyvind ihlen, and beate seibt for helpful comments on earlier drafts and svein harald milde for help with promoting the survey. the supplementary material for this article can be found online at: https://www.frontiersin.org/articles/ . /fpsyg. . /full#supplementary-material the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.copyright © zickfeld, schubert, herting, grahe and faasse. this is an openaccess article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- - d yloxp authors: tambo, ernest; ugwu, chidiebere e.; guan, yayi; wei, ding; xiao-ning,; xiao-nong, zhou title: china-africa health development initiatives: benefits and implications for shaping innovative and evidence-informed national health policies and programs in sub-saharan african countries date: journal: int j mch aids doi: nan sha: doc_id: cord_uid: d yloxp background and introduction: this review paper examines the growing implications of china’s engagement in shaping innovative national initiatives against infectious diseases and poverty control and elimination in african countries. it seeks to understand the factors and enhancers that can promote mutual and innovative health development initiatives, and those that are necessary in generating reliable and quality data for evidence-based contextual policy, priorities and programs. methods: we examined the china-africa health cooperation in supporting global health agenda on infectious diseases such as malaria, schistosomiasis, ebola, tb, hiv/aids, neglected tropical diseases (ntds) prevention, control and elimination spanning a period of years. we reviewed referenced publications, global support data, and extensive sources related to and other emerging epidemics and infectious diseases of poverty, programs and interventions, health systems development issues, challenges, opportunities and investments. published literature in pubmed, scopus, google scholar, books and web-based peer-reviewed journal articles, government annual reports were assessed from the first forum on china-africa cooperation (focac) in november to december third ministerial conferences. results: our findings highlight current shared public health challenges and emphasize the need to nurture, develop and establish effective, functional and sustainable health systems capacity to detect and respond to all public health threats and epidemic burdens, evidence-based programs and quality care outcomes. china’s significant health diplomacy emphasizes the importance of health financing in establishing health development commitment and investment in improving the gains and opportunities, importantly efficiency and value health priorities and planning. conclusions and global health implications: strengthening china-africa health development agenda towards collective commitment and investment in quality care delivery, effective programs coverage and efficiency, preparedness and emergency response is needed in transforming african health information systems, and local health governance structures and management in emerging epidemics. furthermore, innovative evidence of operational joint solutions and strategies are critical in advancing healthcare delivery, and further enhancing universal health care, and sustainable development goals to attain global health improvements and economic prosperity. in a rapidly globalizing world with increasing health and epidemiologic transitions, the international community and multilateralism have become highly active, coordinated and robust. the effectiveness of these initiatives depends on the effectiveness of regional and international cooperation on health challenges and issues. [ ] there are, however, little substantive information and knowledge gaps on how international cooperation and activities can best be used as tools for the management of global health and attainment of sustainable development goals (sdgs). [ , ] china-africa heath development initiatives is timely to address public health and health research gaps, south-south health development platforms and cooperation in shaping innovative national health evidence policies, priorities, programs and benefits in developing countries. international bilateral or multilateral cooperation on health development has been evolving rapidly since the late twentieth century to meet the increasing needs of vulnerable populations, moving forward effective universal health coverage (uhc) and sdgs. [ , ] in addition, to face the challenges of health and epidemiologic transitions, ageing and globalization challenges, collaborative diplomacy on health security have become more vital than ever in not only saving lives and improving public health but also in improving and providing long lasting benefits to both world's poorest and developed countries. at the same time, however, the rising concern on response and funding from international health actors (who, world bank, un/undp, etc.) remains challenging and requires more efforts and collaboration in harmonizing multilateral efforts and timely actions in emergencies situations. [ , ] while the news have often reported on the growth of chinese involvement in africa, there has been very little literature on its effects on public health. there is a need for deeper analysis on china's cooperation and efforts at improving public health large-scale development in africa. there are no statistics showing declines in mortality or disease burden. furthermore, it's still unclear exactly how the chinese approach differs from the western approach, as the difference between the "horizontal" and "vertical" approaches are never described practically or operationally. [ , , ] moreover, there is an urgent need to understand factors that can promote mutual and beneficial health development initiatives. [ , ] the growing trend and quest for chinese multilateral cooperation is increasingly paramount and imperative in tackling the persistent global financial crisis, reducing mass unemployment, and revamping the public burden of infectious diseases of poverty. [ , ] strategic and timely china-africa health development cooperation is much needed in training and capacity development, exchanges, technical assistance and technology transfer. also, strengthening health systems in scaling up health and medical skills transfer to achieve universal coverage, health equity and overall long-term benefits of improved quality healthcare delivery towards sustainable national development and growth. [ , , ] reciprocally, to support china in meeting up with the growing demand on natural resources and citizenry needs, international laws and declarations are critical areas for international cooperation. the current political environment and commitment to address health problems has created unprecedented opportunities for bilateral health cooperation. [ , ] furthermore, as china has become an increasingly important part of global health over the past decades, interest in china's international health cooperation has increased among public health professionals internationally and in china. [ , , ] thus, this systematic analysis of china-africa cooperation is timely in leveraging on infectious diseases and poverty alleviation health experiences and lessons learned in reshaping strategic health diplomacy formulation and enhancing successful approaches in health programs and networks in africa. [ , ] the importance of international, multilateral cooperation for health and disease prevention and control has been recognized as a vital approach and instrument in global health agenda. however, there is a dearth of literature on the potential impact of china strategic diplomacy and policy approaches on the global health inter-dependence, focusing mainly on aspects of existing and emerging threats from disease prevention and control to elimination programs and strategies. [ , ] few scholarly publications have paid attention to the behavior and politics of global actors. primarily, how china-africa health development will shape the global health priorities cooperation and collaboration requires further investigation. [ ] [ ] [ ] [ ] in china, there exists a few articles regarding international cooperation on health concerns aspects of social science. [ , , ] to address the operational and translation research to health policy and practice gaps, challenges and opportunities, more systematic analyses might be required in further understanding the importance of strategic and comprehensive engagement. [ , , ] jointly and mutually beneficial africa-china heath development initiatives could be the turning point for collaborative support and research projects, resource sharing and analysis for new public health policy dimensions and strategic impact. programmatic and robust partnerships are paramount in fostering context health and sustainable public health innovations for health information for all generations. it will, in turn, impact on communities and populations, fostering efficient and effective global health initiatives towards enhanced economic trade, growth and stability, promoting the course of human rights and equity, reinforcement of environmental and wildlife protection and regulations, access and use of health services and medical commodities in achieving uhc and mainstreaming of the sdgs. [ , ] this review paper examines the implications of china engagement in global health initiatives in africa particularly as it relates to the benefits in health systems strengthening and innovations, emerging epidemics and infectious diseases of poverty initiatives prevention, control and elimination. it seeks an understanding of the drivers and operational enhancers that can promote innovative health development initiatives necessary for reliable and quality data for evidencebased contextual policy, priorities and programs of global health impact. a systematic literature review examined chinese international health cooperation and global health agenda on infectious diseases prevention, control and elimination. in particular, challenges and opportunities related to ebola and other emerging epidemics as well as health systems development issues, global health investment and support were reviewed. referenced publications and extensive sources of data include books, pubmed, scopus, and google scholar and webbased peers reviewed journal articles, government annual reports and conference proceedings, policy reports and conference papers. the books reviewed were related to health, public policy and international cooperation. the journal articles concern all of this paper's research areas since the first forum on china-africa cooperation (focac) and the third ministerial conference from november, to december, . government documents came from the china-africa partnership members, related countries' government agencies (e.g. ministry of health) and other international agencies and organizations, such as global fund, world health organization (who), the world bank and the united nations (un). [ , ] all review materials were published, and experts 'reports were assessed. published papers on chinese foreign diplomacy and policy reports and previous chinese literature in relation to infectious diseases prevention and control and elimination programs, research and funding were reviewed to trace international health cooperation actions, information communication and strategies including forum on china-africa cooperation (focac) declarations on health development in and in beijing and cape town respectively. [ , ] furthermore, screened abstracts of the citations were identified for potentially relevant studies and full text documents were obtained for relevant publications. the articles were scrutinized to ensure that multiple publications from the same study related to trade and commerce, socio-economic, science and technology transfer were excluded. this systematic literature search which identified unique records were reviewed and records were excluded based on review of the title and abstract. overall, full publications and reports met the inclusion criteria and were analyzed ( figure ). www.mchandaids.org | © global health and education projects, inc. china-africa engagement represents a comprehensive view of the relationship at maintaining the momentum of high-level exchanges, mutual trust and practical cooperation in acknowledging the efforts and contributions made by china to support africa's peaceful and stable development. the year undoubtedly marked a milestone in sino-african relations, maintaining china's tradition in diplomacy by promoting special consultation in support of the south-south cooperation, sino-african trade and commerce bloc and intergovernmental authority on development (igad). the paradigm shift in the chinese global health is one of the most important geopolitical cooperation of our time. china's initiative at promoting peace and social justice enhanced the pace of chinese participation in helping african countries resolve conflicts. hence, the chinese government continues to work and support the international partnership and collaboration with african union in safeguarding peace and stability in africa, promoting the development of africa, and advancing the integration process of africa. the forum on china-africa cooperation (focac), continues to deepen the new type of china-africa strategic partnership by advancing economic and trade cooperation, and actively exploring a common path that reflects both china's and africa's realities in reducing the major causes of emerging threats and diseases in these countries. our findings showed that in the last two decades ( - ), the focac has been targeted at promoting win-win mutual aid under the multilateral framework, thus strengthening cooperation in health, agriculture and food security. focac has also improved the level of investment and finance cooperation, by supporting africa's infrastructure construction needs and capacity building in attaining uhc, from millennium development goals (mdgs) to attaining sdgs through china-africa "one health" strategy. for example, the west africa's ebola outbreak that affected sierra leone, liberia and guinea witnessed the importance of china partnership in fighting ebola, and the needs for economic and social reconstruction in the post-ebola period. the chinese government worked with international community, humanitarian agencies and frontline non-governmental organizations including african countries to contain and control ebola epidemics in west africa. compared to other developed countries, china provided a robust technical and non-technical assistance to countries in and around the affected west africa sub-region valued at about $ million (usd), and pledged an extra $ million (usd) to the un response multi-partner trust fund to support recovery and rehabilitation process of the affected countries. in addition, china also provided logistics in major affected provinces, including the supply and free distribution of ebola protection kits, mobile laboratory testing vehicles and building new national ebola research laboratories. also skills development of over , health workers and health professional were improved through training and capacity development. there was also post-ebola recovery and reconstruction plans and assistance in social and economic development projects in the most affected countries namely guinea, liberia and sierra leone. the china-africa relations has grown into a new development era with major pillars such as political equality and mutual trust, promoting win-win collaboration, mutually enriching cultural exchanges, mutual joint health projects, public safety and security, coordinated china-africa wider range solidarity for economic partnership, cooperative and interestingly, the second ministerial forum of china-africa health development was held in cape town, south africa in october . its theme was promoting the availability of healthcare service in africa in improving china-africa's cooperation in public health in post-ebola era. there were more than participants, including the health ministers of china and over african countries, as well as representatives from the au and international organizations such as the world health organization and unaids. the meeting adopted the cape town declaration and its implementation framework to promote china-africa collaboration in public health. it developed a roadmap for china and african countries to work together to address the key health problems affecting the african continent. the latter johannesburg summit was the second summit since the inception of focac years ago and the first held in africa. the timely conference resulted in upgrading new type of china-africa relationship into a comprehensive strategic and cooperative partnership. as a marked indication of this collaboration, china pledged to provide $ billion (usd) funding support for major china-africa cooperation plans to be implemented in health-related challenges and issues. these ranged from addressing poor access and availability of quality and essential medicines and medical devices, weak health systems and capacity development, lack of entrepreneurship and technology transfer, unreliable and inexistent monitoring and evaluation (m&e) programs/projects. noteworthy, weak regional approach and national sustained health policy reforms, inadequacies in skills and knowledge capabilities to tackle emerging epidemics and infectious diseases with limited resources were documented and should be addressed. the new plans also cover industrialization, agricultural modernization, infrastructure, financial cooperation, green development, trade and investment facilitation, poverty reduction, public health, cultural and people-to-people exchanges, upholding regional peace and security. ten ( ) cooperation plans were based on the blueprints to guide the african union (au) agenda on africa's development in the coming years towards meeting africa's needs and citizenry benefits. their aim will be to address the three bottlenecks holding back africa's development that is: inadequate infrastructure, lack of professional and skilled personnel, and funding shortage. each plan will have chinese financial, technical or material support and will provide a strong development impetus to future china-africa cooperation including africa-china young leaders' forum. strengthening china-africa cooperation in agricultural modernization, agricultural technology transfer and management requires investment in capacity building development at improving complete africa's agricultural production, to food auto-sufficiency value chain and productivity. building up capability is an important way to contribute to food security in africa, and should be given priority in the context of china-africa cooperation projects. the cooperation will enhance agricultural transformation upgrading, increase agricultural production and processing and safeguard food security in africa bearing in mind the prevailing malnutrition and food shortages that directly impact population health. strengthening weak capacity development and health systems is a major priority to tackle the bottlenecks hindering independent and sustainable development of africa. proactive china-africa concrete priorities and measures should be encouraged for chinese and african entrepreneurs, businesses and financial institutions to expand investment through various means, such as public-private partnership (ppp) and build-operate-transfer (bot), to support african flagship projects in african countries. these include, the programme for infrastructure development and the chinese presidential infrastructure championing initiatives in africa, in addition to building railroad, highway, regional aviation, ports, electricity, water supply, information and communication and other infrastructure projects. supporting african countries in establishing transportation facilitating infrastructure connectivity and economic integration in africa. furthermore, china plans to build transnational and trans-regional infrastructure www.mchandaids.org | © global health and education projects, inc. projects to achieve sub-regional connectivity and integration. both parties can combine the national development needs and demand in fostering economically-beneficial projects and drive africa's infrastructure construction in a balanced and orderly manner. adequate planning and coordination of health development initiatives, construction and renovation, and research collaborative networks in particular promoting construction of transnational highway networks has commenced. there is an urgent need to establish joint china-africa bureau for health development initiatives that will enhance coordination and evaluation of projects. likewise, establishing comprehensive human and infrastructure capacity building and transfer of technology is core. furthermore, china-africa businesses investment, construction and operation in africa should be explored. expansion in vaccine production and medical devices, agriculture and water resources, solar, wind and renewable energy, biomass power generation in power transmission and transformation and maintenance should be nurtured. while advancing its own development, china tries to offer what assistance it can to africa without setting any political conditions, and to benefit african people through developmental advances. in recent years, china has implemented measures adopted at the focac ministerial conferences. china has actively developed cooperation with africa in areas relating to public amenities, medical and health care, climate change and environmental protection, humanitarian aid, and other fields. china has also strengthened cultural and educational exchanges and scientific and technological cooperation in an effort to improve africa's ability to develop independently. china has offered assistance to africa in digging wells for water supplies, and in building affordable housing, broadcasting and telecommunications facilities, and cultural and educational sites in an effort to improve the productive and living conditions of local people. since , china has carried out dozens of welldigging projects in the sudan, malawi, zimbabwe, djibouti, guinea and togo, playing a positive role in easing water problems for local people. it has also provided support for the building of portable dwellings in south sudan, schools in benin, and rural schools in malawi, and in doing so, improved local living conditions and educational facilities. china's largest aid project in the central african republic is the construction of the boali no. hydropower station, which, after it was completed , greatly relieved electricity shortages in bangui and surrounding areas with potential usefulness in improving data access and information sharing for public health benefits. supporting cultural and educational exchanges make up an important part of the new type of strategic partnership between china and africa. by supporting young africans studying in china, sending young chinese volunteers to africa and developing joint research initiatives, china tries to promote mutual understanding between china and african countries and strengthening the social foundation of their friendship. holding human resource training programs and courses are important components of capacity building. from to , china held various training courses for countries and regions in africa; the courses involved a total of , officials and technicians, and covered topics relating to economics, foreign affairs, energy, industry, agriculture, forestry, animal husbandry and fishing, medicine and health care, inspection and quarantine, climate change, security, and some other fields. in addition, chinese medical teams, agricultural experts and enterprises located in africa have also trained local people in an effort to enhance local technological capabilities and upgrading china-africa cooperation in science and technology. from to , in advancing cooperation in medical and health care, china helped build hospitals in ghana, zimbabwe and other african countries. china has also sent medical teams to african countries and regions, treating over . million patients. in recent years, in addition to building hospitals, donating drugs and organizing medical training programs, china has also launched an initiative called "brightness or "evidence" action," to treat cataract patients and provided mobile hospitals. china also built bilaterally-run eye centers, and helped build demonstration and training centers for diagnosis and treatment technologies, thereby effectively advancing sino-african cooperation in medical and health care. china also gave african researchers the chance to do post-doctoral research in china and donated , yuan ($ , ) worth of research equipment to each of the researchers who had returned to their home countries to work upon completing their joint research projects in china. chinese aid and investment in africa health development have made substantial contributions to the continent's development over the last years. china-africa health development builds on the existing focac platform to coordinate health research program that aims to advance capacity and technology transfer to cutting-edge research. in advancing access, uptake and utilization of health commodities in tackling china and africa health needs and issues. filling these important gaps and challenges requires collection and production of real-time evidence care development trajectory. investing in priorities health needs, economic and political, scientific and technological development and empowerment inequalities should be addressed through this win-win mutual partnership with institutions and other international stakeholders in line with global health engagement in infectious and emerging diseases and epidemics especially in africa and china. further, this is necessary in strengthening international health commitment and investment towards new model of health bilateral development that is based on equality, accountability, mutual respect that is more balanced, stable, human rights, inclusive and harmonious society. industrialization, diversification of trade, infrastructure development, and regional economic integration are all the right ingredients for africa's sound economic future. however, in the near term, in light of china's own economic slowdown, questions do exist about the implications of china's economic ties with africa and the sustainability. china has implemented "african talents program" to train , african personnel in various sectors, offered , government scholarships, and build cultural and vocational skills training facilities in african countries. china and africa will deepen their cooperation in the health sector, step up high-level exchanges in health-related fields and hold a china-africa high-level health development programs and activities. china will continue to send medical workers to africa, while continuing to run the "brightness action" campaign in africa to provide free treatment for cataract patients. it will also help african countries enhance their capacity building in meteorological infrastructure and forest protection and management of potential threats and disasters. the research capacity of local partners in china-africa relations has reached a new historic level. africa, a continent full of hope and thirst for development, has become one of the world's fastest growing regions, while china, the world's largest developing country, and has maintained forward momentum in its development. with increasing common interests and mutual needs, the two sides have great opportunities to accelerate their economic and trade cooperation. currently, the chinese people are working hard to realize the chinese dream of national revival, while african people are committed to the african dream of gaining strength through unity and achieving development and renewal. with a spirit of mutual respect and win-win cooperation, china will continue to take concrete measures to build a sino-african community of shared destinies featuring all-round, diversified and deep cooperation. it will work to advance china-africa economic and www.mchandaids.org | © global health and education projects, inc. trade cooperation to help both sides make their respective dreams come true. china is also willing to enhance its cooperation with the rest of the world to promote africa's prosperity and development. china and africa should work together to promote the development of the "china-africa joint research centre" project and cooperate in biodiversity protection, prevention and treatment of desertification, sustainable forest management and modern agriculture demonstration. the chinese side will support africa in implementing clean energy and wild life protection projects, environment friendly agricultural projects and smart city construction projects. strengthening china-africa "one health" strategy cooperation through wildlife and environment protection will help african countries to improve their protection and conservation capabilities. there should be more efforts in building environmental capacities in african countries with training opportunities on environmental and ecological conservation. the possibility of cooperating on joint wildlife protection projects against the illegal trade of fauna and flora products, especially by addressing endangered species poaching, deforestation and environment, degradation and climate change impact on the african continent, should be explored. in its first -years of china-africa partnership implementation plans, china and africa share the view that the current development strategies of china-africa partnerships are highly compatible in fostering china centenary goals and africa union (au) agenda. the two sides shall make full use of their comparative advantages to transform and upgrade mutually beneficial cooperation focusing on better quality and higher efficiency to ensure the common prosperity of their peoples. [ , ] joint health research establishment is needed for a comprehensive strategic and cooperative partnership for china-africa mutual trust, win-win results and sustained economic growth. [ , , , [ ] [ ] [ ] health and medical technology capacity building and transfer, exchanges and mutual learning is needed in enhancing chinese and african citizenry, mutual assistance in public health security and safety. promoting healthcare solidarity and cooperation can be very supportive in enhancing national health planning and interventions implementation between china and african countries in international affairs. [ , , , ] moreover, improving and encouraging care delivery strategic mechanisms such as bilateral joint and strategic dialogues, foreign ministries' political consultations, and joint/mixed commissions on economic and trade cooperation is imperative; through exchanges and cooperation between the national people's congress of china and african national parliaments, regional parliaments, the pan-african parliament and the african parliamentary union, to consolidate the traditional medicines integration in china-africa friendship and promoting mutually beneficial cooperation. [ , , , , , ] our findings documented that china's commitment to continuously support africa in many areas include agriculture and health sector, trade and commerce, science and technology projects implementation. these included construction of regional and community hospitals and treatment centers, infrastructures and facilities to fight infectious diseases, support by chinese medical care delivery teams and improve capacities to respond to public health and sanitary crises throughout africa including dr congo, cameroon, togo, ivory coast, angola, namibia, mozambique, sudan, algeria, south africa, zambia, egypt, nigeria, ghana, liberia, guinea and sierra leone. these equipped ultramodern infrastructure and facilities investment include emergency, resuscitation, pediatrics, surgery, obstetric and gynecology, medical imaging, and related technical units worth billions of us dollars (figure ). these joint efforts are positive milestones to strengthen intercontinental cooperation in view of attaining a sustainable impact in achieving universal health coverage and access to basic medicine. in particular, accelerating the fight against hiv/aids, tb, malaria, schistosomiasis, maternal-child health, reproductive health and improving universal immunization coverage against vaccine preventable diseases across africa. [ ] [ ] [ ] [ ] chinese comprehensive and pragmatic efforts was once again documented when the chinese government immediately offered emergency relief to the three west african countries most affected by ebola and to their neighboring countries of ghana, mali, togo, benin, drc, the republic of congo, nigeria, cote d'ivoire, senegal and guinea-bissau. with the situation turning more serious and based on the needs of epidemic regions, china later announced three consecutive rounds of assistance. china has also promised that in so far as ebola persists in africa, her assistance will not stop. [ , , , , ] china stood shoulder-to-shoulder with the african people in fighting ebola to the final victory of global disease free generations. west africa ebola epidemics - led to net losses of $ . billion us dollars in the three most affected countries (liberia, sierra leone, guinea) in terms of gross domestic products (gdp). as these countries embark on recovery and reconstruction, china has promised assistance in health systems strengthening, capacity building, health infrastructures and equipment support, amongst others. [ , , , ] the urgent need for data and information sharing, material and technical transfer cannot be over emphasized in improving public health and medical resources access through mutual commitments and support. promoting health data and information sharing, educational exchanges and capacity development to support the establishment of robust infectious diseases surveillance-response systems in african countries and all remote provinces/cities is imperative in institutionalization of china-africa forum on cooperation between provinces or local governments. [ , , , , ] the china-africa development fund "cad-fund" is one of new methods for china-african new strategic partnership, which was fully controlled by the chinese government. cad fund is one of the eight measures which was announced by chinese government at the beijing summit of the focac in november th , aimed to support chinese companies to develop the cooperation with africa and enter the african market. [ , , ] distinctive characteristics in the capital nature, the business area, and operation mode is continually following the investment philosophy: to build up "bridge linking" and "connection" of the economic and trade cooperation between china and africa; to enhance self-develop capability of africa; to strictly fulfill the investment environment and social responsibility; to promote mutually beneficial and win-win between china and africa by market-oriented operation. [ , , ] cad-fund is a pioneering move in the process of mutual and beneficial china-africa cooperation. it remedied the gap under the traditional model of free aid and loans. with the increasing african countries double public health burden (chronic illnesses and infectious diseases), new investment models and market-oriented economic development and operation should be examined in achieving sustained and healthy dual or self-development. [ , , ] the direct investment is essential. improving people's livelihood for african regions by additional large scale (e.g.: network project) investment to african countries could be beneficial in long terms. [ , ] for instance, the chinese government officially approved the establishment of the cad-fund, with first-phase funding, usd billion, provided by china development bank. cad-fund operated independently based on market economy principles under a standardized corporate governance structure. china development bank (cdb), the shareholder, has a great wealth of experience in project review and management and is backed up with sound expert resources. having invested in five funds and three specialized fund management companies, the bank has developed sophisticated fund management and risk control systems. cdb has accumulated profound experience vis-à-vis investing in africa through its "going global" initiative. [ ] [ ] [ ] cdb, by virtue of its overall resources and advantages, will provide a high level of professional support. again, on the investment side, the ministry of commerce revealed that china's direct investment in africa stood at $ . billion (usd) in the first half of , falling over percent year on year. the downturn is attributed to the sluggish global economic recovery, international commodity fluctuations, and the ebola outbreaks. [ , , ] globalization and global health initiatives on infectious diseases of poverty associated consequences have shown the world is closely linked as emerging threats and epidemics of infectious diseases can strike anywhere at any time irrespective of race, religion and financial capacity of the country. these have precipitated growing opportunities in internationalization of south-south and south-north health cooperation in changing outcomes. [ , ] the advances in technological development and increases in global interconnections are increasingly being utilized inexpensive and prompt health information communication diffusion broadly and interdependence between different people, regions and continent benefits. [ , ] improvements in communication and information technologies has enabled international responses to health threats and disaster crisis more rapidly and in a coordinated fashion, [ ] bringing about greater sharing of information and increasing international interactions and collaboration. [ ] globalization requires increasing cooperation among countries to ensure the stability and security of the global system, a reason why implementation of international agreements and joint declarations has become important. [ , ] for instance, industrial demand and globalization coupled with intense urbanization have been generating new ecological, climate and environmental threats and associated consequences beyond local, regional boundaries and worldwide. these consequences and issues have raised the need for international cooperation and foreign assistance agreements either as direct delivery of services, capacity transfer or implementation of health interventions such as the global fund to fight aids, tuberculosis and malaria. [ , , , ] in today's more interdependent world, international cooperation, which involves the interaction of countries, international organizations and non-government actors, shapes values, policies and rules. as globalization continues to widen the gaps, development and implementation of comprehensive health models between developing and developed nations, the interest in global health partnership and foreign assistance effectiveness has grown in importance at improving funding on health systems priorities including scaling up access to essential medicines and service delivery, universal health coverage and building new primary healthcare facilities. [ , , , ] international mutual cooperation and aid is one of the most effective weapons in reshaping and transforming regional and national health capabilities which benefits through provision of global public goods, infectious disease control and alleviation of poverty. [ , ] the widespread influence of globalization has increased the need for international cooperation to address emerging opportunities for and threats to global health in improving the health status of populations in developing nations. [ , ] as of november , the majority of african exports to china remains in natural resources. according to the statistics by chinese customs, crude oil, iron ore, diamonds, and agricultural products together accounted for . percent of chinese imports from africa during the first three quarters of . and this number is on the low end because china's demand for raw materials has been suppressed by its economic slowdown this year. in this sense, china's intention of downplaying the importance of natural resources in sino-africa trade in its policy manifestation is clear, given the mutually understandable winwin image associated with sino-africa economic relations aspirations. china's international health development cooperation initiatives since the s, health privatization and reforms expectations and outcomes from international coalitions were formed to address the heavy global challenges, including national burden of infectious diseases, poverty and inequality. with the global funds support from early , the vertical approach to funding and aid has been gradually shifting to a horizontal approach and from mere bilateral efforts to multilateral organizations, local and international ngos, aimed at reshaping major funding, cooperation, new alliances and networks. [ , ] furthermore, boosting provision of aid or humanitarian assistance paradigm shift from a small-scale task plan to large multiple programs financial support projects and programs. multifaceted nature and complexity of health and the multi-sectorial interactions that influence it have induced an increasing number of organizations to become active in the health field. [ , ] broad-ranging partnerships are increasingly being set up to target specific health problems. [ , ] for example, to achieve roll back malaria or polio eradication a global partnership was formed with, among others, ministries of health in polio-endemic countries, rotary international, united nations children's fund (unicef), the governments of australia, canada, denmark, japan, the united kingdom and the united states. reciprocally, from to , the eu contributed € . million to hiv/aids prevention in china, setting up six provincial level regional training centers to provide technical assistance to medical personnel in hiv/aids prevention. [ , ] this collaborative support is advantageous for capacity building, educational exchanges between institutions of all levels and dual technology transfer. such efforts have been reported between china and the united kingdom (uk), the us, and australia in research and development and helpful in solving health issues and developmental challenges including climate changes and globalization of trade and travel. [ , , ] previously, the establishment of cooperation between china and other countries has been done through the signing of agreements and regular corporate communication. contemporary advances in implementation mechanisms are performed by joint engagement and participation in mutual win-win partnership and joint health programs funding or investment seeking based on local and national priorities and real time field interventions. [ , ] furthermore, china has dispatched more than medical teams and more than , medical personnel to african countries. chinese governments highly valued and appraised local people and the team's devotion, willingly and generosity in providing medical services, training and technical assistance, in strengthening health systems development through focac partnership. [ , , ] in contrast to previous international vertical health approach, chinese horizontal approach and process (people-people approach and relations) has been appraised in responding to the need of the populations. there is an urgent need for reliable and effective evidence in strengthening health systems development including constructing health care facilities, providing medicines and medical equipment, improving more targeted care access and utilization require contextual and scalable community-based programs and activities beneficial to both chinese and african citizenry. [ , , , , ] china's importance in sustainable development and global health goals, is aimed not only in fighting poverty and health inequality among the world's people, but in enhancing opportunities to live a free, healthy and fulfilled life. [ , , ] achieving health for all remains an important component of sdg targets and requires reducing national public health burden of infectious diseases of poverty. addressing knowledge gaps between the developing and developed countries require innovative international and multilateral cooperation with priorities on significant infectious diseases, emerging epidemics, the rise of obesity related cardiometabolic and other www.mchandaids.org | © global health and education projects, inc. chronic diseases. the mdgs, adopted and supported after the millennium summit of the united nations in september , provided a substantial progress in the reduction of poverty and marked improvements in infectious diseases and some neglected tropical diseases in most endemic countries through the global funds. it also offered other bilateral aid to the poorest and vulnerable populations worldwide by improving maternal health, reducing child mortality, while combating hiv/aids, malaria and other diseases. [ , , , [ ] [ ] [ ] attaining the sdgs and health for all by depends primarily on national efforts supported by domestic and regional public-private partnerships and global strategy of increasing access of the world's poor to essential health services. it also depends on support from international multilateral cooperation and collaboration within countries. [ , , ] further efforts should be devoted at reducing inequality and poverty in health aimed at accelerating progress towards the sdgs and should be a pubic priority. it is worth mentioning that there is still disproportionate health disparity between developing and developed countries. [ , ] for example children life expectancy chances are dramatically different depending on where they are born. in china life expectancy is longer than in african countries due to premature mortality ratio associated with malaria, tuberculosis and hiv/aids as well as chronic infections, mainly maternal-child and elderly healthcare delivery. [ , , , ] china's global solidarity and partnership support from national income and resources could be a role model on how to assist and work a win-win bilateral collaborative network, technical assistance during threats and epidemics disaster crisis for the safe of humanity, environment and ecosystem. china health expenditure increased more than fold and accounted for . % of the gross domestic product (gdp) in . [ , , ] who supported by other governments continues to provide necessary technical and financial support to china through renewed strategic cooperation agenda on transfer of know-how and skills to africa in tackling infectious diseases control towards elimination. [ , , , ] chinese cooperation is aimed at achieving global health responsibility, which entails strengthening health systems, improving universal health coverage and reducing morbidity and mortality from major infectious diseases of poverty. such recent efforts in the field of public health include multiple partnerships between the national institute for parasitic diseases (nipd), shanghai with several african institutions and universities in the areas of capacity development and training, technology transfer and exchanges coordination and leadership. [ , , ] most importantly, is the implementation of malaria and schistosomiasis elimination networks across africa (e.g., tanzania, zanzibar, sudan). [ , ] lessons learned and technical assistance from chinese researchers, ongoing consultation on strategic partnership could be very important in strengthening joint malaria and schistosomiasis projects network with sudan, cameroon, zimbabwe, south africa and mali are substantial opportunities. in addition, provision of technical support and colossal solidarity supply of personal protective equipment (ppe) in sierra leone, liberia and guinea were of tremendous assistance both to humanitarian frontline organizations as well as chinese teams and local community health benefits in west africa ebola containments and community rehabilitation. for example, china provides funding and technology, while who guides technical support and coordination. [ , , ] furthermore, in , the chinese government assisted in , to develop and implement strategic plans on snail control and elimination of schistosomiasis. it should be recalled that chinese experts have provide technical assistance to pakistan, nepal, lao, myanmar, vietnam, nigeria, tanzania, angola and namibia to assist in global polio eradication and global fund for malaria and hiv/aids and tuberculosis (gfmat) efforts. [ , , ] china is also reducing inequalities in health and contributing to strengthening global health through supporting collaboration in the global health arena. china is strengthening national and regional priorities in line with international health regulations (ihr) ( ), strengthening the asia pacific strategy for emerging diseases (apsed) network, global schistosomiasis alliance (gsa) to arboviralnet. [ , [ ] [ ] [ ] [ ] this will enhance capacity in health security and diplomatic power to create maneuver space for international multi-polar geopolitics and financial systems. china has become a giant economic power and vital component of the international commodity chain, allowing for more effective broad-based consultation and participation on global health issues and international finance via different channels by active support of multilateral diplomacy and politics. [ , , , ] the first world bank trust fund to end poverty was established in promoting growing china's interest and role in global health development, and china's health reforms leadership in reducing poverty and strengthening both health systems resource and infrastructure investment. [ ] this is essential in embracing and upholding performance-based to outcome-based financing in partners countries. some good examples of chinese initiatives in global health need further assessment including the use the new partnership in optimizing institutional governance, organizational structure, social and environmental benefits towards social cohesion, healthy life and living, wellbeing of all citizens and sustainable development at all levels. [ , , , , , , ] integration of china multilateral policies in projects and programs will be a tremendous boost with the increasingly geographic expansion and spread of emerging epidemics and climate changes impacts on global health concern. proactive china-africa leadership commitment and investment is needed in addressing in tie-bound manner evolving local or global threats and emergency situations in endangering collective health initiatives in upholding international health regulations (ihr). [ ] [ ] [ ] the sudden emergence in of severe acute respiratory syndrome (sars) in china was a vivid example of how international health cooperation in the future depends on a better appreciation of the meaning of modernization, as interpreted by each country, and recognition that modernization itself is a complexity of many factors. [ , ] future multilateral cooperation will be influenced by strategic innovative multi-sectoral partnerships, health programming and resource mobilization, bilateral to multilateral governance systems, creation of enabling institutional space, effectiveness and outcomes impact. new and advanced health diplomacy, and foreign health policy in public health systems is an important point of entry and worth pursuing by the joint china and africa interests and values. [ , , , ] health as an instrument of foreign diplomacy and policy presents several mutual gains both for community and its populations' protection. safety and security are health priorities that can be improved through further public health development cooperation. international multilateralism in health development under china-africa partnership holds great promise in increasing opportunities and businesses and diminishing traditional unilateralism over time. [ ] [ ] [ ] nurturing sustainable joint institutional projects that promote community-based programs could be vital for active engagement in policy discourse, participation and community empowerment. the un's sustainable development policy functions and goals coordination will be overtaken by global partnerships or other agencies to develop new international health norms and standards. [ , , , , , ] ultimately, the quality and effectiveness of china-africa health development initiatives and programs, when channeled through government and institutions partnerships, have the potential strengths in improving good governance and accountability in global health security. [ , [ ] [ ] [ ] [ ] china's economic importance in improving china-africa health development initiatives in strengthening contextual health priorities and programs is imperative. fostering china-africa innovative evidence-based national health policies and health operational joint solutions and strategies is critical in advancing healthcare delivery access to, availability and effective implementation. moreover, in shaping programs and interventions benefits in further improving uhc, sdgs in attaining global health and economic prosperity in africa. ethical considerations: this paper was based on the review of existing and publicly-available information. conflict of interest: the authors advances in addressing technical challenges of point-of-care diagnostics in resourcelimited settings. expert review of molecular diagnostics china's engagement in global health governance: a critical analysis of china's assistance to the health sector of africa the dragons' gift: the real story of china in africa china and foreign investors. the end of a beautiful friendship china's approach in the blooming south-south health cooperation: chances, challenges and the way forward china-africa health cooperation for years: achievements, challenges and future. china-africa health collaboration in the era of global health diplomacy global aspirations, local realities: the role of social science research in controlling neglected tropical diseases taiwan after the elections europe and china; a cooperation with complex legal dimensions state council of the people's republic of china. china's foreign aid. beijing: state council information office china's "new" diplomacy china's strategic environment: implications for diplomacy china's role as a global health donor in africa: what can we learn from studying under reported resource flows? harmonious society" and "harmonious world": china"s policy discourse under hu jintao ) fighting malaria ebola wreaks havoc in sierra leone. infectious diseases of poverty surveillanceresponse systems: the key to elimination of tropical diseases scaling up impact of malaria control programmes: a tale of events in sub-saharan africa and people's republic of china technology innovation for infectious diseases in the developing world global health diplomacy: a global health sciences working paper brazil"s ascendance: the soft power role of global health diplomacy strengthening health systems: "new continent" in china-africa health collaborations. paper presented at the china health forum china"s soft power in africa: from the "beijing consensus" to health diplomacy key players in global health: how brazil, russia, india, china and south africa are influencing the game china-africa development cooperation: identity transformation and system reconstruction global health governance and mechanism for china and africa's participation. paper presented at the china health forum global health : a world converging within a generation historical evolution and chinese definition of global health considerations when disseminating american-developed, evidence-based health promotion programs in china china engages global health governance: processes and dilemmas an appeal to the global health community for a tripartite innovation: an «essential diagnostics list china's engagement in global health governance: a critical analysis of china's assistance to the health sector of africa the political origins of health inequity: the perspective of the youth commission on global governance for health china's distinctive engagement in global health ground-truthing" chinese development finance in africa china's provincial diplomacy to africa: applications to health cooperation key: cord- -hurpcc e authors: yadava, om prakash title: covid- : are there lessons? date: - - journal: indian j thorac cardiovasc surg doi: . /s - - -w sha: doc_id: cord_uid: hurpcc e nan health is a state subject, and there was a glaring lack of communication and camaraderie between the federal and state structures. even fiscal-federalism was conspicuous in its absence or partisanship. the centre's support to states was lacking or delayed. contradictory orders were flying fast and furious, more inclined to the political ideologies of the incumbent administration, rather than a response to an apolitical disease. morning orders were rescinded by the evening, thereby not only confusing, but demoralizing, the entire workforce, who as such were dealing with the uncertainties of an, yet not well-known, enemy. lesson: too many cooks spoil the broth. there should be well-defined line of leadership, and demarcation of domains of each stakeholder, to avoid chaos and confusion of response, as also for an optimum utilization of scarce resources. 'no' knowledge better than 'some' knowledge as much, if not more, damage from covid- has come from fear psychosis, rather than the virus itself. the root cause of this was the lack of an authentic, transparent, and verifiable single source of information. half-baked knowledge, and at times even gumption, was dished out in the electronic and print media by self-styled 'godmen of medicine' as the 'gospel truth'. in fact, the entire official response to the pandemic was governed by all and sundry including paediatricians, gastroenterologists, dental surgeons and the likes, rather than the public health experts, who were nowhere to be seen, even in the horizon. it is with a view to addressing this gap in knowledge that the indian association of thoracic and cardiovascular surgeons (iacts) has tried to assimilate the scant, and at times confusing and contradictory, knowledge and has issued its guidelines (published later in this issue) to assist our cardiovascular and thoracic surgical fraternity in framing their responses to the challenges of practice in covid times. lesson: let the domain experts lead, take the centre stage and call shots. rest, irrespective of their clout, must for once, take a back stage, sans a mumble. it did not take long for our basic health structure, specially in the government sector, to be exposed and laid bare. professionals have been bemoaning, ever since the independence that our spending on health sector is woefully short and that the intangible benefits of health should not be compared with the tangibles from the manufacturing industry, but should be monetised in terms of disability adjusted life years (daly) saved. we are still lucky that even though the disease is ravaging in the urban areas, it has largely spared the rural hinterland, but i fear it may not be for long, and at which stage, the deficiencies of the primary healthcare infrastructure in terms of primary health centres, community health centres and district hospitals will be exposed further. already, there are signs that the government is waking up to this realisation and the sooner it does, the better it shall be for the future of the country. lesson: government must increase its allocation to health sector to at least % of gdp and focus on strengthening the primary care. as a corollary of the foregoing, the out of pocket spending on health in india is an overwhelming - % and two-thirds to three-fourths of all healthcare is in the private sector. instead of realising this fact and embracing the private sector with an all-encompassing hug, the government has always treated the latter with suspicion, disdain and a 'carrot-stick' policy. successive governments have tried to reign and subjugate it through oppressive legislations and archaic regulations. this attitude needs to be changed and profit, albeit reasonable, should be accepted as ethical, moral and in fact a necessity for a vibrant and effective private healthcare system, to meet the health needs of the society. crushing private sector at the altar of the socio-political agenda of the incumbent political dispensation is going to be to the disadvantage of all stakeholders, and last but not the least the government itself. lesson: create a policy environment for ppp to thrive and flourish regulation is a necessity and that is given. however, it must address the aspirations of the society it serves. therefore, it must factor the ground realities and the resources available, and incorporate the social, economic and cultural confounders to be effective. unfortunately, we seem to be caught in a warp, where we are copying regulations from the developed world and issuing regulatory guidelines as 'one size fits all' solution to the needs of the entire country-a country, as vast and diverse in all dimensions, as india. the recent urgency seen in regulatory bodies in clearing trials and fast tracking of approvals for new drugs is worth appreciating, but even in routine matters, regulatory jigsaw should be simplified and made user-friendly. lesson: we should focus more on standardisation with a view to enabling deregulation. india has neither the ecosystem nor the finances, for basic, molecular level core research. it therefore needs to look at the low-hanging fruits of translational research. we already have enough lab knowledge; we just need to transform it into bed-side knowledge. india is lucky to have an amazing pool of young talent, just suited for this kind of research. this can even subsequently be commercialised and monetised and may help address the economic woes of the country. the information technology (it) and biotechnology companies can team up for developing rapid testing kits for not only coronavirus, but for other diseases rampant in the country, and concentrate on developing point-of-care tests. a start-up culture should be developed with the government providing the handhold by provisioning for the initial seed money, the physical infrastructure, patenting and subsequent commercialisation and marketing of technologies. 'aatam nirbhar bharat' and 'vocal for local' are good initiatives, but need to be transformed from jargon to reality, something which has not happened in the past--'make in india' and 'india shining' initiatives having flustered badly. lesson: 'bench to bedside' innovation is the 'mantra' but we need to 'walk the talk'. healthcare is heading to a new normal. necessity is the mother of invention and a lot of bright minds, either by design or by default, developed new processes and technologies during the covid- outbreak. sure enough some of them will fall by the wayside, but at least some and more meaningful ones will continue to survive even after the covid- pandemic is over, either because of the value they have demonstrated, or maybe even because of necessity. connectivity in india has improved following the global system for mobile communication (gsm) roll-out and indian space research organisation's (isro) support through provisioning of free satellite time for public health initiatives. technologies can now be leveraged, not only for diagnostics but also for healthcare delivery with successful models in south indian states delivering intensive care through tele intensive care units (icus) and ophthalmology services, specially for diabetic retinopathy, being delivered in rural areas through mobile care units. thus, tele-medicine and tele-consultations would, in all likelihood, become a norm in the future. remote sensing and monitoring and point-of-care testing would decongest the bursting at the seams tertiary care hospitals. for a lot of diseases and illnesses, for which we always believed that patient care in a secondary or tertiary care hospital was mandatory, domiciliary care and conservative management have dawned as an effective alternative. the flattening of curve in delhi, and available infrastructure not stretching itself, was achieved entirely with the realisation that 'domiciliary quarantine' was as effective as 'institutional quarantine'. even 'analytics' to change 'big data' into action and value-driven partnership of industry with physicians is the need of the day. lesson: leverage bio technologies and it to deliver healthcare at the door step of the masses. covid- has been a big epidemiological experiment, albeit carried by nature. the universal outcry on a sudden drop in non-covid hospitalisations in all specialities, not only of elective cases but also emergencies, without a proportionate and countervailing increase in non-covid mortalities should sensitise us all-the medical fraternity, public and the government, to the overarching benefits of holistic living and good lifestyle. whether these realisations will stay or be as ephemeral as the virus, only time shall tell. lesson: a stitch in time saves nine. just as we concentrate on our covid- responses, we must not forget that the main health burden of india lies in non-covid illnesses. a recent modelling study in lancet global health showed that the mortality from malaria was expected to increase by % over years as against the pre-covid levels, of tuberculosis by % and hiv by % [ ] . all the routine vaccination programmes have taken a back seat. schools are closed and the midday meal programmes are suspended. this, along with the attendant economic woes of the covid- , compounded further by the natural disasters of floods and typhoons like 'amphan', will have a snowball effect on additional problems of nutritional deficiencies in children and infectious illnesses, besides psychological and mental disorders creeping in. a thought should also be spared both for the physical and mental health of the health task force and the corona warriors in general. let this calamity not go waste and let us treat this as an opportunity, a new dawn in the healthcare landscape of our country. potential impact of the covid- pandemic on hiv, tuberculosis, and malaria in low-income and middle-income countries: a modelling study publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -f sq gy authors: wong, chi-yan; tang, catherine so-kum title: practice of habitual and volitional health behaviors to prevent severe acute respiratory syndrome among chinese adolescents in hong kong date: - - journal: journal of adolescent health doi: . /j.jadohealth. . . sha: doc_id: cord_uid: f sq gy abstract purpose to explore factors relating to the practice of habitual and volitional health behaviors against the severe acute respiratory syndrome (sars) among chinese adolescents in hong kong. methods a community telephone survey was conducted with chinese adolescents. random-digit dialing of the local residential telephone directory was used to select respondents, who were asked to provide information on their practice of sars preventive health behaviors and associated factors as specified by the health belief model. these factors included perceived threat of sars, perceived benefits and barriers in practicing sars preventive health behaviors, cues to action, knowledge of sars, and self-efficacy. hierarchical regression analyses were conducted to determine salient correlates of habitual and volitional health behaviors against sars. results about . % of respondents reported practicing all three recommended habitual health behaviors. another . % indicated consistent practice of volitional health behavior of facemask-wearing to prevent sars. results of hierarchical regression analyses showed that habitual health behaviors against sars were related to perceived health threat and environmental cues. for facemask-wearing, salient correlates were environmental cues, rates of sars habitual health behaviors, younger age, and perceived health threat. conclusions the health belief model is useful in understanding chinese adolescents’ practice of health behaviors, especially volitional health behaviors. current global outbreak of severe acute respiratory syndrome (sars) poses a great threat to international public health. with the gradual containment of the disease in various countries, there is an increasing concern to prevent it from becoming another endemic infectious disease in human populations [ , ] . among reported cases of sars infection, about % to % were aged to years [ , ] , with clinical presentations and courses of the disease being as severe as those of adult infected patients [ ] . this study aimed to examine factors relating to the practice of sars preventive health behaviors among chinese adolescents in hong kong. adolescence is often viewed as a time of optimum health, relative immortality and invincibility to illnesses. however, research has indicated that adolescents tend to have low adherence to health advice and often engage in risky behaviors that may put them at risk for life-endangering conditions or make them vulnerable to illnesses later in life [ - ] . there is an increasing belief that adolescents should be targeted for health promotion activities [ , ] . various psychosocial models have been used to understand factors relating to adolescents' practice of health behaviors to facilitate the design and planning of health pro-motion strategies. models that include perceived threat as a core component are most useful in understanding the practice of a variety of adolescent preventive health behaviors [ ] . among these models, the present study focuses on the health belief model (hbm). according to the hbm [ ] , perceived threat refers to beliefs about the seriousness of a particular disease and one's susceptibility to this disease. the basic hbm also has three other core components, namely perceived benefits, perceived barriers, and cues to action. perceived benefits refer to the degree to which an individual perceives particular health behaviors as beneficial or effective, whereas perceived barriers are perceived costs of undertaking specific health behaviors. cues to action are prompts that remind or facilitate an individual to practice certain health behaviors. two other components, knowledge and self-efficacy, have been added in the more recent modification of the hbm [ ] [ ] [ ] . self-efficacy refers to beliefs in an individual's own ability to perform the desired health behaviors. the hbm has been used to study various health behaviors among western adolescent samples, including condom use for acquired immunodeficiency syndrome (aids)/human immunodeficiency virus (hiv) prevention [ ] , hiv testing [ ] , prevention of teenage pregnancy [ ] , and diabetes self-management [ ] . similarly, the hbm is also useful in understanding chinese adolescent health behaviors such as influenza vaccination [ ] and hiv preventive behaviors [ ] . across these studies, perceived threat is consistently found to be the most powerful correlate of various health behaviors. the significance of other components varies with different target health behaviors and samples. furthermore, the hbm is found to be more predictive of volitional health behaviors that are novel and new to the behavioral repertoire of an individual than habitual health behaviors that are usually well established and over-learned [ ] [ ] [ ] . in hong kong, adolescents' practice of preventive health behaviors against sars can also be understood in light of the hbm. their perceived threat of sars may have been increased by daily reports of sars infection figures [ ] , different media programs on sars, documentation about patients infected with or having died of sars, and class suspension during the outbreak of sars [ ] . they may also perceive preventive health behaviors against sars as having more benefits than costs, as local health authorities often emphasize their effectiveness and ease to perform [ ] . there are abundant environmental cues to remind adolescents to adhere to health advice, and these include posters and notices about sars preventive behaviors in noticeable areas in schools/public areas as well as disinfection stations with free alcohol towels and liquid soap in major shopping malls. furthermore, updated information about sars and effective ways to perform relevant preventive health behaviors are also disseminated through the media, seminars, and public education activities. as guided by the hbm, it was hypothesized that per-ceived threat, perceived benefits, cues to action, knowledge, and self-efficacy would have positive associations; whereas perceived barriers would have negative correlations with sars preventive health behaviors. furthermore, it was also hypothesized that components of the hbm would be more predictive of volitional than habitual health behaviors. this study was part of a larger study on sars preventive behaviors of the general public in hong kong, which was conducted from march to april , . at the time of this study, sars was spreading quickly in the local community with to new infections daily. causative agents, transmission route, diagnostic tests, and specific treatments of the disease were still not yet fully known. local health authorities had since implemented enhanced infection-control procedures in all hospitals, cohorting of sars patients, suspension of classes for schools and universities, and ordering of infected individuals and their close contacts to quarantine themselves at home for at least days. in the community, health advice was disseminated and vigorous community-wide public education and prevention programs in relationship to sars were also launched. the larger study was conducted using a telephone interview method. telephone numbers were randomly selected from the local residential telephone directory for , which covered all listed telephone numbers in all regions of hong kong. the last two digits of telephone numbers were deleted and replaced by two random numbers generated by the computer to capture unlisted telephone numbers. when telephones were busy or there was no answer, three follow-up calls on different dates and times were attempted before substituting a new telephone number. individuals who first answered the phone, who were aged years or above, and who were of chinese ethnicity were invited to a -minute telephone interview on their demographic data, responses to local sars outbreak, and practice of various sars preventive health behaviors. the decision was made a priori to recruit until interviews were completed. out of valid household contacts, households refused to participate in the study, were incomplete interviews with more than half of the required information missing, and successful telephone interviews were conducted with households. the success rate, calculated as percentages of completes to complete plus refusals/incompletes, was . %. the sampling error was . percentage points. among successful telephone interviews in the larger study, % (n ϭ ) of the respondents were aged to years. the proportion of adolescents to adults in the larger study was comparable to . % in the general population as reported in the hong kong population census. for the purpose of the present study, the adolescent subsample of the larger study was used for subsequent data analyses. among these adolescents (n ϭ ), . % were male and . % were female. their mean age was . years (sd ϭ . ), with the age distribution being % for - years, . % for - years, and . % for - years. almost all respondents ( . %) were in school, with only . % working and . % awaiting employment. sars preventive health behaviors. local health authorities had recommended various sars preventive health behaviors, which were grouped into habitual or volitional health behaviors. for habitual health behaviors, respondents were asked whether or not they had engaged in each of the three recommended sars preventive health behaviors in the past week: building up good body immunity (taking a proper diet, having regular exercise), maintaining good personal hygiene (washing hands properly, covering nose and mouth when sneezing and coughing), and ensuring home environment clean and with good ventilation ("yes" or "no" answers). a habitual health behavior index was computed for each respondent by summing up affirmative responses of these three items. for volitional health behavior, respondents were asked to indicate with a -point scale how often they wore facemasks to prevent contracting and spreading of sars in the past week. the scale was scored from as "never," as "occasionally," and as "almost all the time," with high scores representing more frequent or consistent wearing of facemasks. perceived threat of sars. six items were used to measure the degree to which respondents perceived sars as a health threat: whether or not respondents felt vulnerable to contracting sars, were fearful of sars, worried about its spread to the community, concerned hong kong was becoming a quarantine city, knew or had previous contact with individuals infected with sars, and had respiratory infection symptoms such as sore throat, dry cough, fever, muscle ache, and shortness of breath. respondents answered "yes" or "no" to each item. the perceived threat score was then computed by summing affirmative responses to these six items. a high score indicates the perception of sars as being a great health threat. the internal consistency alpha of the perceived threat scale was . . perceived benefits of sars preventive health behaviors. respondents were asked to indicate on a -point scale the degree to which they believed health behaviors as suggested by local health authorities could prevent the contracting and spreading of sars. the item was scored from as "very ineffective" to as "very effective," with high scores indicating the perception of having great benefits in practicing sars preventive health behaviors. perceived barriers. respondents were asked to respond "yes" or "no" regarding whether they had difficulty and felt inconvenienced in practicing recommended sars preventive health behaviors. the perceived barriers score was formed by summing affirmative responses to these two items. a high score indicates the perception of great barriers in practicing these behaviors. cues to action. respondents were asked to indicate whether or not they perceived their family members and local government had prompted them to practice the suggested sars preventive health behaviors ("yes" or "no" answers). a summary score was computed by summing affirmative responses. high scores indicate the perception of environmental cues to practice these behaviors. respondents were asked to indicate whether or not they perceived they had adequate knowledge about sars and whether local health authorities had provided adequate information on sars. these two items were scored on -point likert scales ranging from as "very inadequate" to as "very adequate." high scores indicate respondents perceiving themselves as being knowledgeable about the disease and its prevention. respondents were asked to indicate the degree to which they believed they were able to practice the suggested sars preventive health behaviors. responses were coded on a -point scale ranging from as "totally incapable" to as "totally capable." high scores indicate high levels of self-efficacy in practicing these behaviors. respondents were asked about their age, gender, educational attainment, working status, and personal monthly income. statistical analyses in this study were conducted using spss . software (spss inc., chicago, illinois). descriptive statistics on the practice of sars habitual and volitional health behaviors were examined. pearson correlation analyses were conducted to examine associations among sars preventive health behaviors, demographic characteristics, and six components of the hbm (i.e., perceived threat, perceived benefits, perceived barriers, environmental cues, knowledge, and self-efficacy). hierarchical regression analyses were then performed to test the hbm and to identify salient predictors of the habitual and volitional health behaviors, respectively. for habitual health behaviors, slightly more than half of respondents ( . %) reported practicing all three health behaviors as suggested by local health authorities (i.e., building up good body immunity, maintaining good personal hygiene, and keeping home environment clean with good indoor ventilation). another % of respondents practiced two of the three suggested habitual health behaviors, another % practiced only one, and the remaining . % practiced none of these behaviors. for volitional health behavior of facemask-wearing, about . % of respondents indicated consistent practice, . % reported occasional practice, and . % did not wear facemasks at all. results of chi-square tests found no significant gender difference on both habitual and volitional health behaviors against sars (p Ͼ . ). respondents were then divided into two groups according to their volitional health behaviors to determine the presence of any group differences in their demographics, psychological variables, and habitual health behaviors. respondents who reported consistent and occasional use of facemasks were grouped as "users" (n ϭ ), whereas those who never wore facemasks for sars prevention were classified as "nonusers" (n ϭ ). results of student's t-tests showed that compared with users, nonusers of facemasks were older (mean ϭ . vs. . , t ϭ Ϫ . , p Ͻ . ), perceived less personal threat of sars infection (mean ϭ . vs . , t ϭ . , p Ͻ . ), detected fewer environmental cues to practice sars preventive behaviors (mean ϭ . , . , t ϭ . , p Ͻ . ), and practiced fewer sars habitual health behaviors (mean ϭ . , . , t ϭ . , p Ͻ . ). pearson correlation analyses were conducted to examine associations among sars preventive health behaviors, demographic characteristics, and six components of the hbm (i.e., perceived threat, perceived benefits, perceived barriers, environmental cues, knowledge, and self-efficacy) ( table ) . for habitual health behaviors against sars, significant correlates were perceived threat, environmental cues, and perceived benefits (r ϭ . , . , and . , respectively; p Ͻ . ). for volitional health behaviors of facemask-wearing to prevent sars, environmental cues, practice of habitual health behaviors, and perceived threat were positive correlates (r ϭ . , . , and . , respectively; p Ͻ . ). age was negatively related to facemask-wearing (r ϭ Ϫ. , p Ͻ . ). as a number of variables were related to sars preventive health behaviors, hierarchical regression analyses were conducted to determine the respective contribution of these variables when their common variances were also considered. separate hierarchical regression analysis was conducted for habitual and volitional health behaviors. for both types of health behaviors, demographic variables of age and gender were entered as block . four core components of the hbm, including perceived threat, perceived benefits and barriers, and cues to action, were entered as block . more recent hbm components of knowledge and self-efficacy were entered as block . for volitional health behavior of facemask-wearing, rates of the practice of habitual health behaviors against sars was added as block . final models of these two regression analyses were presented in table . for habitual health behaviors against sars, results of the regression analysis showed that three blocks of variables together accounted for . % of the variance. demographic variables in block were insignificant, whereas core hbm components in block contributed an additional . % of the variance (⌬r ϭ . , f change ϭ . , p Ͻ . ). more recent components of the hbm in block were not related to habitual health behaviors (p Ͼ . ). beta values of the final model of this regression analysis indicated that habitual health behaviors against sars were related to perceived threat and environmental cues (␤ ϭ . and . , respectively, p Ͻ . ). for volitional health behavior of facemask-wearing, results showed that four blocks of variables together accounted for . % of the variance. demographic variables in block accounted for % of the variance (⌬r ϭ . , f change ϭ . , p Ͻ . ), whereas core components of the hbm contributed an additional . % of the variance (⌬r ϭ . , f change ϭ . , p Ͻ . ). more recent components of the hbm in block were not significant (p Ͼ . ). the practice of habitual health behaviors in block was significant and contributed another % of the variance (⌬r ϭ . , f change ϭ . , p Ͻ . ), even after effects of demographics and hbm components were considered. beta values of the final model of this regression analysis indicated that facemask-wearing was related to environmental cues, practice of habitual health behaviors against sars, younger age, and perceived threat (␤ ϭ . , . , Ϫ. , and . , respectively, p Ͻ . ). this study showed that chinese adolescents' rates of sars preventive health behaviors were relatively high when compared with other health behaviors practiced by western [ - ] and chinese youths [ ] . results showed that slightly more than half of the present adolescent sample practiced all three suggested habitual health behaviors. among all adolescent respondents, . % also reported consistent practice of volitional health behavior of facemask-wearing to prevent the contracting and spreading of sars. in comparison, only one-third of surveyed youths reported sun protection measures in australia [ ] , regular fruit or vegetable consumption in the united states [ ] , and consistent condom use for hiv/aids prevention in hong kong [ ] . high rates of sars preventive health behaviors as reported by the present adolescent sample might have been related to the perceived threat of the disease and vigorous public education efforts of the local government [ ] . this study suggested that contrary to the common conception that adolescents are generally irresponsible and noncompliant [ ] , some adolescents would practice recommended health behaviors given adequate public education and mobilization. it should also be noted that in the larger study in which the present adolescent sample was selected, about . % of adult respondents reported the wearing of facemasks to prevent sars [ ] . in other words, adolescents' rates of sars preventive behaviors were substantially lower than rates of adult respondents. thus, adolescents should remain one of the target groups for sars prevention activities. an understanding of underlying motivational factors specific to adolescents would greatly facilitate the design and implementation of related prevention programs for adolescents. this study showed that among six components of the hbm, perceived threat and cues to action were more salient correlates of sars preventive health behaviors among chinese adolescents. these findings were consistent with existing literature on the hbm. perceived threat has been consistently found to be the most important correlate of a variety of health behaviors among western [ ] [ ] [ ] [ ] and chinese youths [ , ] . cues to action are not always included in studies on the hbm. when included, this component is also related to health behaviors in both general [ ] and adolescent samples [ ] . for adolescents, cues to action are the most effective when they are also built into their social networks such as peers, family, and school systems [ ] . indeed, at the time of this study, there were environmental cues not only to adolescents, but also cues to remind parents and school personnel to ensure that their children or students adhere to health advice on sars prevention [ ] . this study also found that more recent components of the hbm, knowledge and self-efficacy, were insignificant correlates of sars preventive health behaviors. in fact, past studies on both western [ ] and chinese samples [ , ] have also found that knowledge of the disease alone is inadequate to motivate adolescents to practice the desired health behaviors. instead, knowledge is found to play a significant role in increasing perceived threat and vulnerability about the disease [ , ] . it should also be noted that at the time of this study, very little was known about sars regarding its causative agents, transmission route, and specific treatments. thus, it is understandable that the meager knowledge about this disease did not emerge as a salient correlate. it is plausible that as more information about the disease is available, such knowledge may become a salient factor in influencing adolescents' health behaviors. previous studies have documented that self-efficacy is a salient correlate of adolescent health behaviors [ , , ] . however, present results showed that selfefficacy did not have significant contribution to the understanding of sars preventive health behaviors when other components of the hbm were also considered. it may be that sars preventive health behaviors are relatively easy to perform. most adolescents can easily manage habitual behaviors of washing hands, covering nose and mouth with tissue when coughing and sneezing, and maintaining good indoor ventilation. even for the novel behavior of facemask-wearing, it is easily learned and requires little skill. results of the present study support the hypothesis that psychosocial models such as the hbm were more predictive of volitional than habitual health behaviors [ ] [ ] [ ] . specifically, core hbm components of perceived threat, perceived benefits and barriers, and environmental cues contributed an additional . % of the variance in volitional health behavior of facemask-wearing; whereas these components accounted for only . % of the variance in habitual health behaviors. these findings may be explained by individuals' deliberate evaluation process. most psychosocial models, including the hbm, suggest that deliberate evaluation of the threat related to the disease as well as benefits, barriers, and cues surrounding specific health behaviors are crucial in predicting whether or not an individual practices a certain health behavior [ , , ] . in this study, consistent facemask-wearing was novel to most chinese adolescents in hong kong and required active evaluation of these psychosocial factors before they decided to practice such behavior. as mentioned, cues to wear facemasks were not only targeted at individual adolescents but were also available in adolescents' social network through their parents and teachers [ ] . thus, core components of the hbm emerged as more salient correlates of facemask-wearing than of habitual health behaviors. present findings also revealed that habitual and volitional health behaviors were moderately related to each other. in other words, chinese adolescents who practiced habitual health behaviors such as washing hands, taking proper diet with regular exercise, and keeping good indoor ventilation were also more likely to practice the specific volitional health behavior of facemask-wearing. as pointed out by some researchers [ ] , different health behaviors may be interrelated to influence health. for example, smoking may reduce the desire to exercise, and intense exercise may affect food intake; whereas eating nutritious food does not necessarily preclude an individual from eating "junk" food. similarly, increases in the practice of one type of health behavior may facilitate adherence to other health behaviors. further research on the clustering of different health behaviors may facilitate clearer understanding of adolescent health behaviors. this study had several limitations. first, it was part of a larger study in which data were collected through residential telephone interviews. consent had to first be obtained from persons who answered the telephone before the conduct of the interview. there was no information about demographic characteristics or reasons for refusal for those who declined the interview. thus, it remained uncertain whether adolescents' response rate was at the same level as adults. second, retrospective self-reports of adolescents were collected without external verification, and results might be subject to recall and social desirability bias. there might also be doubts about the validity of responses by telephone interviews. however, previous studies have documented the similarity of responses between telephone and face-to-face interviews [ ] , and telephone interviews have become an increasingly acceptable methodology in collecting estimates of health behaviors [ ] . third, the measurement of the target sars preventive behaviors was crude and without any contextual information. it was possible that adolescents' practice of sars preventive behaviors might differ at home, in school, or in public places. lastly, this study focused on core components of the hbm in understanding the practice of sars preventive health behaviors. components of other psychosocial models that are of particular relevance to adolescent samples, such as subjective normative beliefs of the theory of planned behavior [ ] , were not examined. despite these limitations, results of this study have significant implications not only for the prevention of sars, but also for general health promotion activities for chinese adolescents. it should be noted that these health education programs are the most effective if they are also made available to adolescents' parents, family members, and school personnel [ ] . in this study, perceived threat and cues to action were found to be powerful motivating factors in adolescents' practice of preventive health behaviors. thus, health education and prevention programs for chinese adolescents need to attend to these two core components. this study demonstrated that chinese adolescents' practice of health behaviors could be fostered when given adequate public education and mobilization. in particular, the health belief model was useful in understanding both habitual and 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and individual health behaviors long-term reliability and validity alcoholism diagnosis and symptoms in a large national telephone interview survey the feasibility of using a telephone-administered survey for determining nutritional service needs of noninstitutionalized older adults in rural areas: time and costs key: cord- - vtqte z authors: gopichandran, vijayaprasad; subramaniam, sudharshini; kalsingh, maria jusler title: covid- pandemic: a litmus test of trust in the health system date: - - journal: asian bioeth rev doi: . /s - - - sha: doc_id: cord_uid: vtqte z the pandemic caused by the sars-cov novel coronavirus is creating a global crisis. there is a global ambience of uncertainty and anxiety. in addition, nations have imposed strict and restrictive public health measures including lockdowns. in this heightened time of vulnerability, public cooperation to preventive measures depends on trust and confidence in the health system. trust is the optimistic acceptance of the vulnerability in the belief that the health system has best intentions. on the other hand, confidence is assessed based on previous experiences with the health system. trust and confidence in the health system motivate people to accept the public health interventions and cooperate with them. building trust and confidence therefore becomes an ethical imperative. this article analyses the covid- pandemic in the south indian state of tamil nadu and the state’s response to this pandemic. further, it applies the trust-confidence-cooperation framework of risk management to analyse the influence of public trust and confidence on the tamil nadu health system in the context of the preventive strategies adopted by the state. finally, the article proposes a six-pronged strategy to build trust and confidence in health system functions to improve cooperation to pandemic containment measures. the sars-cov virus is spreading fast and has created a pandemic of far reaching consequences. as of april , there are . million confirmed cases globally with . million deaths due to covid- . in india, there are , confirmed cases with deaths (world health organization ). several countries have instated strict restrictive measures to contain the spread of the respiratory virus. india has instilled one of the strictest lockdowns in history, of . billion people, currently counting more than days ( un news ) . this has led to a tremendous burden on people of all sections of the society, especially among the poor (human rights watch ). the combination of fear due to the illness and restrictive public health measures putting people into difficulties has led to a heightened state of vulnerability. in such situations of vulnerability, the relationship between the people and the health system is strongly dependent on trust. trust is the optimistic feeling of acceptance of one's vulnerability in the hope that the party who is trusted will act in one's best interest (hall et al. ) . o'neill describes demonstration of trustworthiness as the basis of trusting community-health system relationships. she argues that trust cannot be built by intention and effort (o'neill ) . a global pandemic is one of the greatest litmus tests of trust in a health system. trust has both intrinsic and instrumental values during pandemic times. having trust in the health system reassures people that the health system will take care of them and help them carry on with their lives. a high level of trust in the health system also fosters a sense of cooperation with the system in adopting all public health measures that are recommended by the system (kehoe and ponting ) . mistrust in the health system can be counterproductive in effective control of the infection (van der weerd et al. ) . this is particularly important when the public health measures are highly restrictive. therefore, public trust in the health system during pandemic times becomes an ethical imperative. this article will analyse the covid- pandemic in the south indian state of tamil nadu with a brief description of the measures adopted by the state, the role of trust and confidence in motivating the community to cooperate with the health system and potential strategies for building trust and confidence of people. health system response to covid- in tamil nadu, india tamil nadu saw its first case of covid- on march (josephine m. ). the state has implemented several important pandemic control measures. firstly, a large number of international travellers who arrived in tamil nadu were placed on home quarantine and were followed up daily through telephone calls (chandna ) . active contact tracing of all confirmed cases of covid- was performed by the health care providers including all those who attended a religious conference in new delhi and contracted the illness from the meeting (trivedi ) . aggressive cluster containment activities are being implemented in which the containment zone and its perimeter are well described and health care workers go door to door conducting active surveillance of covid- like symptoms (ministry of health and family welfare ). for the contact tracing and cluster containment, the state adopted the policy of 'collective action of the entire government machinery' meaning the health, revenue, police and other departments also engaged in these activities at the district level (chandna ) . the state has also initiated steps and is working hard to prepare isolation beds, intensive care unit beds and ventilators. in addition, the department of health and family welfare is active on social media and disseminates information, education and communication actively (directorate of public health and preventive medicine ). in order to enable physical distancing between people, the state announced a stringent lockdown of all commercial, business, education and nonessential activities (the hindu ). the trust-confidence-cooperation model was developed by earle, siegrist and gutscher to describe risk management in organizations (earle et al. ) . this model is based on the premise that the community must have trust and confidence in the state for it to cooperate with the public health control measures to contain covid- . the belief is that if the community perceives that the health system has their best interests in mind and its intentions are to protect the community, it develops trust. the past experiences with the health system during previous outbreaks and emergencies and overall experience of the people with the system builds confidence. it is the presence of this combination of value and intention-based trust and performance-based confidence that motivates people to cooperate with the various risk reduction and mitigation strategies, especially the restrictive ones (earle ) . this model is shown in fig. . the model in fig. is used in the analysis that follows. the trust in the public health system is initially described. this is followed by an analysis of the public confidence in the health system during outbreaks based on past experiences and overall health system functioning. it is argued that trust and confidence in the health system are likely to influence the cooperation with public health interventions listed in the figure. trust in the health system in tamil nadu has been nourished over the years. the state has a robust public health cadre and an efficient public health system, which ensures that the state has some of the best health indicators in the country (gaitonde et al. ) . it is one of the states which has achieved several of the sustainable development goals and is close to achieving several others (vijayakumar ) . the exemplary maternal and child health care system of the state is a model for the country. the logistics and supply chain management of medicines, medicinal products and devices, the tamil nadu medical services corporation, is highly efficient in maintaining an uninterrupted supply chain throughout the state (joy and scaria ) . the chief minister's comprehensive health insurance scheme is one of the earliest insurancebased universal health coverage models in the country (sundari and vidhyapriya ) . the public health and primary care infrastructure in the state is one of the best developed in the country and enjoys a high level of trust in the community for various services (baidya et al. ) . a previous exploration of trust in the public health system in tamil nadu revealed a high level of trust in the primary care system for maternal and child health services as well as for common minor ailments especially in the rural areas and among the poor (gopichandran and chetlapalli ) . however, the public health system has equally faced a few instances of trust deficit with respect to management of outbreaks and infectious disease control operations. during the annual dengue outbreaks, the public health system has been blamed of lack of transparency of reporting cases with dengue (lopez et al. ) . during the dengue epidemic of , the state imposed severe restrictive measures such as random unannounced inspection of households for mosquito breeding, forced entry into houses for inspection and imposing of monetary penalties on households with mosquito breeding, all of which were perceived as highly restrictive and forceful (express news service ). there is some evidence that the system is not trusted for being sensitive to the needs and experiences of the community. thus, there is a fine balance between trust and mistrust in the public health system in tamil nadu. tamil nadu was criticized for not testing enough persons in the early days of the pandemic (bhat ) . but, it gradually increased its testing capacity and by april, it had reached a testing capacity of about tests per day at a rate of . tests per million population, which is higher than the other big states in india like gujrat, maharashtra and andhra pradesh (the hindu data team ). another major criticism was the implementation of non-scientific interventions for infection control. in some districts, the state installed 'disinfection tunnels' which sprayed disinfection solution on people who walked through it, much like a drive through car wash. but this was heavily criticized as the harms of this procedure are more than the benefits, and the state issued a recommendation to close such walk-through disinfection tunnels (ians ). the government was also criticized as suppressing information on the number of cases and number of deaths due to covid- , which the officials have denied (kumar ) . the state was performing well in its covid- control strategies, when the biggest setback came in early april with a spike of cases, all associated with attendance at a conference in new delhi (subramanian b) . the state was criticized initially for identifying a religious minority group as being responsible for this spike. this perpetuated a severe bout of stigmatization of the religious group in the community. but subsequently, the officials took efforts to mitigate the discrimination against the religious group by talking about it and spreading awareness that the illness is not associated with any religion (ramakrishnan ) . the chief minister of the state went on record during a press meet that the state will achieve zero cases of covid- as the lockdown was successful, which was heavily criticized for being unrealistic and uninformed by data (subramanian a ). all of these criticisms have contributed to erosion of confidence in the ability of the health system to control the spread of the infection. this delicate balance between trust-mistrust and eroding confidence in the health system is likely to influence the cooperation of the people with the system in the measures to control the pandemic. therefore, during this crisis period, it is important for the health system to function in a manner that fosters trust and confidence, thus encouraging cooperation with the state's interventions. simple strategies if adopted by the tamil nadu health system can foster trust and confidence, which is very much needed during this crisis. a robust risk communication strategy that strikes a balance between transparency and avoiding unnecessary panic among the people must be evolved to promote trust and confidence building (vijaykumar and raamkumar ) . such a transparent communication provides credible information to the people. this helps people perceive the seriousness of the situation and cooperate with the public health interventions. the tamil nadu health system brings out a daily news bulletin and shares it with the media. ensuring that this line of open and transparent communication is continued is particularly important. close attention to the words used in reporting, the flow of provision of information, avoiding unnecessary sensationalism and providing accurate facts are strategies that can attempt to strike this delicate balance. in the background of a past history of lack of transparency described in the previous section, demonstration of the openness of information is very important to nourish trust. the interventions that the state is adopting to control the pandemic must be backed by sound evidence and must be scientifically valid. if not, it will lead to harm to the people and cause gross trust erosion. use of evidence-based interventions generates a feeling among people that whatever interventions that are being provided are well intentioned. there is significant social stigma associated with being identified as a patient with covid- (ramakrishnan ) . the health workers visit the home of the patient, paste stickers on their door indicating that it is a quarantined house, mark an indelible seal on the hand of the quarantined person and carry out disinfection activities in and around the house of the patient. these interventions invade the privacy of individuals and breaches confidentiality of the health information of the people. it subjects people to shame and stigmatization. this is likely to prevent more and more people from reporting their symptoms and not coming forward for testing in order to escape the stigma associated with the disease. on one hand, these interventions are important to contain the rapid spread of the infection; they also force people to hide from the system out of fear of shame and stigma. this can heavily impact on the success of the containment strategies. preventing public display of the details of infected persons, protecting the privacy of the infected to the maximum extent possible, treating the infected person with respect and dignity and ensuring equal treatment of all people who are infected can promote trust. community engagement can be carried out for most public health interventions (schoch-spana et al. ). community-based active surveillance in the containment areas by volunteers, community-based quarantine and isolation facilities with active community participation, community policing of lockdown measures and distribution of lockdown relief materials through local leaders are all potential community engagement strategies, all of which can encourage trust and promote cooperation. community engagement helps to ensure a sense of ownership of the intervention by the community. it also ensures that the interventions are appropriate and acceptable to them. community engagement gives voice to the affected community and therefore helps to adopt the public health interventions to the values and preferences of the people. primary care services are fundamental rights as they address social determinants of health and are basis to the health and well-being of the people. therefore, there is an ethical imperative to build a resilient health system that can continue to offer routine primary care services such as maternal and child health services, immunization and non-communicable disease services (martineau ) . the state has taken several measures to ensure the uninterrupted maternal and child health services and services for non-communicable diseases such as diabetes and hypertension. women who are due for delivery have been enumerated and the system sends ambulances to the homes of these women to pick them up and drop them back after safe delivery in a hospital. similarly, patients on haemodialysis as well as cancer chemotherapy are picked up and dropped in their homes to ensure uninterrupted services (chandna ) . these interventions help foster confidence and trust. however, these services do not reach everyone in the state, and those who do not receive these services develop a sense of being let down by the system and experience an erosion of confidence. building a resilient health system that withstands the stress of such pandemics and continues to offer regular services is an important measure to build trustworthiness. pandemics are very unsettling times for people. there is an ambient environment of uncertainty and anxiety. it is in such situations that having a trustworthy health system goes a long way in ensuring safety and well-being of people. in tamil nadu though trust in the health system is strong, there are some experiences in the past and some interventions during the covid- control measures which have eroded people's confidence in the system. the health system must now work towards ensuring that the response fosters trust in the people and encourages cooperation to the heavily restrictive public health measures, which are likely to continue for protracted timelines. patient-physician trust among adults of rural tamil nadu: a community-based survey are states like tn testing enough people for covid- ? public health experts say no. the news minute tamil nadu is containing covid- well, and it is not following bhilwara model. the print daily report on public health measures taken for covid- . media bulletin . . . state control room, directorate of public health and preventive asian bioethics review medicine, health and family welfare department trust in risk management: a model-based review of empirical research trust, risk perception and the tcc model of cooperation legal notices issued in dengue drive in tamil nadu: director of public health dissonances and disconnects: the life and times of community-based accountability in the national rural health mission in tamil nadu dimensions and determinants of trust in health care in resource poor settings-a qualitative exploration trust in physicians and medical institutions: what is it, can it be measured, and does it matter? human rights watch. . india: covid- lockdown puts poor at risk. human rights watch no more covid- disinfectant tunnels in tamil nadu. times of india covid- : here's what tamil nadu has been doing since health expenditure and access disparities in india: should not the tnmsc model be adopted nationwide? value importance and value congruence as determinants of trust in health policy actors we are not suppressing figures regarding covid- , says tn health minister. the hindu state view: the case of dengue management and its can of worms people-centred health systems: building more resilient health systems in the wake of the ebola crisis autonomy and trust in bioethics tamil nadu: after battling deadly coronavirus, they are fighting stigma. times of india community engagement: leadership tool for catastrophic health events experts question tn cm's statement that covid- cases will come down in days. the week was tamil nadu govt late to realise coronavirus risk among jamaat delegates? the week changing face of indian health insurance industry (with special reference with chief minister comprehensive health insurance scheme (cmchis)) the hindu. . coronavirus: restrictions in tamil nadu from the hindu data team. . covid- : state-wise tracker for coronavirus cases, deaths and testing rates. the hindu coronavirus: the story of india's largest covid- cluster. the hindu monitoring the level of government trust, risk perception and intention of the general public to adopt protective measures during the influenza a (h n ) pandemic in the netherlands retains third spot in sdg index. the hindu zika reveals india's risk communication challenges and needs coronavirus disease (covid- ): situation report - . world health organization publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgements the authors sincerely acknowledge the contributions of dr priyadarshini key: cord- - ibo gn authors: Ćosić, krešimir; popović, siniša; Šarlija, marko; kesedžić, ivan; jovanovic, tanja title: artificial intelligence in prediction of mental health disorders induced by the covid- pandemic among health care workers date: - - journal: croat med j doi: . /cmj. . . sha: doc_id: cord_uid: ibo gn the coronavirus disease (covid- ) pandemic and its immediate aftermath present a serious threat to the mental health of health care workers (hcws), who may develop elevated rates of anxiety, depression, posttraumatic stress disorder, or even suicidal behaviors. therefore, the aim of this article is to address the problem of prevention of hcws’ mental health disorders by early prediction of individuals at a higher risk of later chronic mental health disorders due to high distress during the covid- pandemic. the article proposes a methodology for prediction of mental health disorders induced by the pandemic, which includes: phase ) objective assessment of the intensity of hcws’ stressor exposure, based on information retrieved from hospital archives and clinical records; phase ) subjective self-report assessment of stress during the covid- pandemic experienced by hcws and their relevant psychological traits; phase ) design and development of appropriate multimodal stimulation paradigms to optimally elicit specific neuro-physiological reactions; phase ) objective measurement and computation of relevant neuro-physiological predictor features based on hcws’ reactions; and phase ) statistical and machine learning analysis of highly heterogeneous data sets obtained in previous phases. the proposed methodology aims to expand traditionally used subjective self-report predictors of mental health disorders with more objective metrics, which is aligned with the recent literature related to predictive modeling based on artificial intelligence. this approach is generally applicable to all those exposed to high levels of stress during the covid- pandemic and might assist mental health practitioners to make diagnoses more quickly and accurately. the coronavirus disease (covid- ) pandemic and its immediate aftermath present a serious threat to the mental health of health care workers (hcws), who may develop elevated rates of anxiety, depression, posttraumatic stress disorder, or even suicidal behaviors. therefore, the aim of this article is to address the problem of prevention of hcws' mental health disorders by early prediction of individuals at a higher risk of later chronic mental health disorders due to high distress during the covid- pandemic. the article proposes a methodology for prediction of mental health disorders induced by the pandemic, which includes: phase ) objective assessment of the intensity of hcws' stressor exposure, based on information retrieved from hospital archives and clinical records; phase ) subjective self-report assessment of stress during the covid- pandemic experienced by hcws and their relevant psychological traits; phase ) design and development of appropriate multimodal stimulation paradigms to optimally elicit specific neuro-physiological reactions; phase ) objective measurement and computation of relevant neuro-physiological predictor features based on hcws' reactions; and phase ) statistical and machine learning analysis of highly heterogeneous data sets obtained in previous phases. the proposed methodology aims to expand traditionally used subjective self-report predictors of mental health disorders with more objective metrics, which is aligned with the recent literature related to predictive modeling based on artificial intelligence. this approach is generally applicable to all those exposed to high levels of stress during the covid- pandemic and might assist mental health practitioners to make diagnoses more quickly and accurately. the coronavirus disease (covid- ) pandemic and its immediate aftermath present a serious threat to the men-tal health of health care workers (hcws), who may develop elevated rates of anxiety, depression, posttraumatic stress disorder (ptsd), or even suicidal behaviors ( ). recent research related to the covid- pandemic ( , ) and middle east respiratory syndrome (mers) outbreak ( ) recognizes that hcws are at high risk for mental illness. therefore, urgent monitoring of their mental health is needed, particularly early prediction and proper treatments of nurses and physicians who were exposed to a high level of distress by working directly with ill or quarantined persons ( ). mental health risks of highly distressed individuals are further increased when they exhibit low overall stress resilience and have other vulnerability factors, such as the general propensity to psychological distress ( ) and low self-control ( ). recognition and identification of such individuals in early stages of acute stress is extremely important in order to prevent the development of more serious long-term mental health disorders, such as ptsd, depression, and suicidal behavior. however, mental disorders are difficult to diagnose, and even more difficult to predict due to the current lack of biomarkers ( ) and humans' subjectivity, as well as unique personalized characteristics of illness that may not be observable by mental health practitioners. currently, the diagnosis of mental health disorders is mainly based on the symptoms categorized according to the diagnostic and statistical manual of mental disorders (dsm- ) ( ). in such circumstances, one of the greatest impacts of digital psychiatry, particularly applied artificial intelligence (ai) and machine learning (ml) ( - ) during the ongoing covid- pandemic, is their ability of early detection and prediction of hcws' mental health deterioration, which can lead to chronic mental health disorders. further-more, ai-based psychiatry may help mental health practitioners redefine mental illnesses more objectively than is currently done by dsm- ( ) . regardless of the specific application, ie, prediction, prevention, or diagnosis, ai-based technologies in psychiatry rely on the identification of specific patterns within highly heterogeneous multimodal sets of data ( ). these big data sets may include various psychometric scales or mood rating scales, brain imaging data, genomics, blood biomarkers, data based on novel monitoring systems (eg, smartphones), data scraped from social media platforms ( ) , speech and language data, facial data, dynamics of the oculometric system, attention assessment based on eye-gaze data, as well as various features based on the analysis of peripheral physiological signals ( , ), eg, respiratory sinus arrhythmia, startle reactivity etc. such ai systems based on multimodal neuro-psycho-physiological features can detect mental health disorders early enough to prevent and reduce the emergence of severe mental illnesses and improve the overall mental health. therefore, ai has the transformational power to change a subjective diagnostic system in psychiatry to a more objective medical discipline. also, a new generation of ai in psychiatry might act as a self-explanatory digital assistant to psychiatrists. definitely, psychiatry today could benefit from ai's ability to analyze data and recognize patterns and hidden warning signs that a psychotherapist might miss. such timely information enables making diagnoses more quickly and accurately, and might be lifesaving particularly for all of those hcws who might have suicidal ideation ( , ) due to heavy mental distress during the covid- pandemic. hence, the aim of this article is to address the problem of prevention of hcws' mental health disorders by early prediction of individuals who may have a higher risk of later chronic mental health disorders due to high distress during the covid- pandemic. in order to reach this aim and enhance traditional subjective diagnostics and risk assessment approaches, the methodology proposed in this article is based on our extensive experimental research on the selection of resilient candidates for special forces during survival, evasion, resistance and escape (s.e.r.e.) training in collaboration with emory university school of medicine, atlanta, united states, and hadassah hebrew university hospital, jerusalem, israel ( ) . similar methodology has been applied in our project related to the selection of resilient candidates for air traffic controllers in cooperation with harvard medical school & massachusetts general hospital and croatia air traffic control ( , ) . these multi-year experimental research projects are based on a variety of questionnaires and experimental measurements, which include a set of comprehensive multimodal stimuli, corresponding multimodal neuro-physiological, oculometric and acoustic/speech responses, and complex feature computation. therefore, we do believe that future clinical research based on the proposed multimodal neuro-psycho-physiological features and ai analysis can detect mental health disorders early enough to prevent and reduce the emergence of severe mental illnesses. such reliable predictors of potential mental health disorders among hcws due to covid- stressors will be crucial for the mental health of hcws and maintaining high efficiency and productivity of medical institutions globally. the proposed methodology, described in figure and in the following phases, includes objective assessment of intensity of hcws' stressor exposure during the covid- pandemic described in phase , subjective assessment of stress experienced by hcws during the covid- pandemic based on the specific psychological questionnaire described in phase , distinctive stimulation paradigms designed and developed within phase , computed neuro-physiological features based on stimulation responses in phase , as well as statistical and ml data analysis described in phase . objective assessment of intensity of hcws' stressor exposure during the covid- pandemic is based on acquiring information from official hospital archives and clinical records regarding their daily schedules during the covid- pandemic, overtime work, the level of threat they experienced, sick leave, etc. these objective metrics of exposure to stressors are proposed based on analysis and adaptation of different questionnaires that have been used for assessment of stressors in military combat deployment and operation ( - ), as well as stressors in virus outbreaks ( ) ( ) ( ) ( ) . the key aim of this phase is to objectively stratify individual hcws according to the objective level of stress to which they were exposed during their clinical service, using the information provided by authorized clinical sources rather than by asking individuals to self-report themselves. phase : subjective stress assessment subjective assessment of stress experienced by hcws during their covid- pandemic clinical service is based on the questionnaire that is developed by a selection of the most appropriate items from general-purpose psychological questionnaires used for early recognition of distress, mental health disorder screening, and stress resilience (eg - ), as well as from specific covid- psychological questionnaires ( - , ). self-reported subjective peritraumatic reactions represent a valuable complement to objective dimensions of stressful situations collected in phase when trying to predict chronic mental health disorders, such as ptsd ( ) . accordingly, subjective self-reports of individual covid- stress intensity and relevant personality traits will also be used as one of the indicators of potential chronic mental health disorders in comparison with more objective metrics developed in phase . this phase is related to the design and development of appropriate multimodal stimulation paradigms in order to optimally elicit specific neuro-psycho-physiological individual reactions among hcw participants ( figure ). accordingly, the appropriate input-output multimodal experimental stimulation paradigms that elicit the specific multimodal features reflecting the impact of stress on the patients' neuro-psycho-physiological state ( ) are usually related to baseline neuro-physiological functioning; wellestablished generic stressful emotional stimuli, such as different versions of acoustic startle stimuli and airblasts; startle modulation paradigms, such as fear-potentiated and anxiety-potentiated startle ( ) , and prepulse inhi- ( ) , and are delivered binaurally through headphones. in order to induce laboratory fear, threat, or anxiety by means of predictable and unpredictable aversive events delivery ( ), other aversive stimuli can be used, eg, combinations of airblasts to the neck, aversive images on the screen and sounds ( ), as well as annoying but not painful electric shocks, eg, . - . ma, -ms duration. existing semantically and emotionally annotated stimuli databases can facilitate efficient and accurate search for optimal aversive audio-visual stimuli to include in the multimodal stimulation paradigms ( , ). cognitive tasks are usually administered through specifically designed programs that allow response duration and accuracy measurement. tion paradigms proposed in the previous phase and computation of corresponding features relevant for prediction of mental health disorders. the proposed methodology is based on state-of-the-art sensors for measurements of the individual's multimodal neuro-psycho-physiological reactions: functional near-infrared spectroscopy (fnirs); electroencephalography (eeg); peripheral physiology, ie, electrocardiography (ecg), electromyography (emg), electrodermal activity (eda), respiration; speech/acoustic and linguistic reactions; and facial/gesture and oculomotor reactions ( , ) . such measurements, obtained as a response to relevant stimuli described in phase , have the potential to objectivize traditional diagnostic methodology in psychiatry. in our laboratory, the biopac mp system (biopac systems inc., goleta, ca, usa) is used for the acquisition of the neuro-physiological signals. a gazepoint gp hd eye-tracker (gazepoint, vancouver, canada) is used for detection of spontaneous blinks, tracking of changes in pupil dilation, and gaze tracking. a microphone and a webcam are used for collecting speech and gesture data, while the fnirs biopac model imager together with the cobi studio software (biopac systems inc.) is used for brain activation measurements. after pre-processing of the neuro-physiological signals, ie, obtained inter-beat interval time-series based on the detected qrs complexes in the ecg signal, preprocessed respiratory and eda data, accordingly filtered emg data for eyeblink startle response assessment, an array of relevant multimodal features is computed ( , ) . these features are elicited and computed according to the relevant research findings related to their associations with specific positive or negative mental health disorder predictors or outcomes, such as stress resilience/vulnerability and other personality traits, distress, anxiety, ptsd, or depression. therefore, these features are defined and computed in a theory-driven manner. examples of such features are resting heart rate ( , ) and heart rate variability (hrv) ( , ) , respiratory sinus arrhythmia ( , ) , hrv-based psychophysiological allostasis ( , ) , emg-based and figure . design and development of multimodal stimulation paradigms for optimal elicitation of specific neuro-psycho-physiological individual reactions; adapted from ( ) . hcw -health care workers; fnirs -functional near-infrared spectroscopy; eeg -electroencephalography; ecg -electrocardiography, emg -electromyography; eda -electrodermal activity. the illustration was partially assembled from public domain/free sources: https://publicdomainvectors.org, http://www.stockunlimited.com, https://commons. wikimedia.org. eda-based startle reactivity ( ), various features related to speech prosody ( ), prefrontal cortex activation on various cognitive tasks ( , ) , and alpha band-related parietal eeg asymmetry ( ) . such integrated multimodal neuropsycho-physiological prediction of mental health disorders emphasizes the importance of combining different multimodal features in enhancing predictive power of the proposed approach, since any single feature in the assessment and prediction of mental health deterioration is a relatively weak discriminator. due to potentially large amounts of highly heterogeneous data, phase is accomplished using cloud storage and cloud computing resources, as shown in figure . statistical correlation-based analyses are expected to provide better insight into the neuro-physiological risk markers for the development of chronic stress-related mental health problems affected by the covid- pandemic. feature selection and classification based on ml, as opposed to statistical methods, would explore more complex interactions between various features in a highly nonlinear manner as-sociated with the inference of risk of hcw individuals for the development of chronic mental health problems. individuals exhibiting high risk of chronic stress-related mental health problems may urgently need as prevention effective and efficient treatments, using state-of-the-art tools and means of digital psychiatry, such as computerized cognitive behavioral therapy ( ) and telepsychiatry, which are efficiently applicable in the early stages of illness ( ) . a more detailed description of the proposed tools and means of statistical and ml analyses is given in the following section. a data-driven verification of various multimodal neuropsycho-physiological features extracted in phase can be obtained by the application of statistical analyses and ml techniques in relation to the objective stress intensity assessment from phase , as well as subjective self-report indicators of experienced stress and relevant psychological traits from phase . phase can provide valuable insight into neuro-psycho-physiological risk markers for the development of chronic stress-related mental/physical problems in the context of the covid- pandemic, figure . multimodal data acquisition and feature computation. illustrated is a subset of features: hr mean -mean heart rate; hr recovery -heart rate recovery; rsa -respiratory sinus arrhythmia; rmssd -root mean square of successive differences; eda as -eda-based startle response measure; emg as -emg-based startle response measure; f voice -voice fundamental frequency; rms voice -voice energy -root mean square; f - -voice formants; zcr -voice zero-crossing rate; pd -pupil dilation; spv -saccadic peak velocity; fnirs hbo -oxygenated hemoglobin. and increase the translational potential of such features. a similar data-mining-based approach has been previously used in the analysis of diagnostic data for differentiating ptsd patients from participants with psychiatric diagnoses other than ptsd ( ) . this work has demonstrated the applicability of ml for the analysis of ptsd, but only based on the data obtained from structured psychiatric interviews and psychiatric scales, which is analogous just to phase of the methodology proposed in this article. in terms of statistical analysis, various correlation analysis approaches can be employed. one example of such methodology is the canonical-correlation analysis (cca), a technique suitable for investigating the relationships between variables coming from distinct sets, eg, the relationship between variables obtained in phase and phase , or phase and phase . in doing so, the cca will provide interpretable linear combinations of variables from different sets that have a maximum correlation. in order to maximize the statistical power of conclusions, ie, to avoid the large statistical corrections due to conducting numerous exploratory tests for significance of correlation coefficients, several particularly well-founded hypotheses should be defined a priori, before the computation of the full correlation matrix. these hypotheses should be those with the most overwhelming evidence from the literature regarding expected pairwise associations between specific objective metrics of the stress intensity exposure, subjective self-report metrics of experienced stress and relevant psychological traits, as well as objectively measured/computed neuro-physiological features. a brief overview of neurophysiological features with the highest predictive potential according to the research references is given in the description of phase . additionally, a subset of the obtained data can be used to separate the participants according to specific group memberships, eg, high distress vs low distress. for example, a recent covid- -related research paper ( ) uses data analogous to our proposed phase and phase to define resilience in the face of exposure to a stressor of a given intensity. however, in that work all data were obtained via self-report, while we propose the integration of objectively assessed stressor severity (phase ) and self-report data (phase ) with the relevant neurophysiological features (phase and phase ). accordingly, various regression analyses or even between-group tests can be conducted. regarding the application of ml, both unsupervised and supervised learning approaches should be considered. unsupervised learning approaches, such as principal component analysis, factor analysis, or cluster analysis, do not require labeled data and can help reveal previously undetected patterns in heterogeneous sets of data, and help in the understanding of the relationships between objective stressor severity, self-report assessments, and neuropsycho-physiological characterization of the participant. for example, a non-classical unsupervised learning approach, based on a brain-inspired spiking neural network (snn) model trained using eeg data, has provided novel insights into the brain functioning in depression and the effects of mindfulness training on the brain connectivity ( ) . such novel unsupervised approaches, based on the spike-timing-dependent plasticity learning rules of the snn connectivity emerging from complex spatio-temporal brain data, like eeg and fnirs, which are considered in the proposed methodology, could help reveal and understand early patterns of mental health deterioration in hcws. when considering labeled data, the main aim of supervised ml, as opposed to statistical methods, is the maximization of classification/prediction accuracy, while sacrificing model explainability and rigorous statistical validation. accordingly, recent work highlights the need to establish an ml framework in psychiatry that nurtures trustworthiness, focusing on explainability, transparency, and generalizability of the obtained models ( ). this approach, regardless of the superior classification/prediction performance, is critical in order for the ai methods to be employed in diagnosis, monitoring, evaluation, and prognosis of mental illness. supervised learning in the context of the proposed methodology can be formulated both in terms of regression and classification tasks. neuro-physiological features obtained in phase can be integrated by a model, eg, support vector machine, random forest, artificial neural network, etc, in the accordingly formulated supervised learning task. for example, data from phase can be used to model various labels emerging from phases and , such as estimation of objective stressor severity, available from phase ; or classification of high vs low distress in hcws based on the data obtained in phase . to summarize, technology based on ai and ml can only be as strong as the data the models are trained on, which is particularly important in mental health diagnostics. currently, for most classification or prediction tasks emerging from the area of mental health, labels are most likely still not quantified well enough to successfully train an algorithm. one possible outcome regarding this labeling issue, as briefly stated in the introductory section, is in data-driven ai technologies helping mental health practitioners re-define mental illnesses more objectively than is currently done in the dsm- . ad-ditionally, ai can help personalize treatments based on the patient's unique characteristics. such unique characteristics are often very subtle and hardly observable by human mental health practitioners. for example, subtle shifts in speech tone or pace can be a sign of mania or depression, and such patterns can now be even more precisely detected by an aidriven system in comparison to humans. ai can exploit language and speech, among many other available modalities, as one of the critical pathways to detecting patient mental states, especially through mobile devices ( ) , which should also be regarded as highly important in the context of prediction of mental health disorders induced by the covid- pandemic. the proposed methodology for prediction of mental health disorders among hcws during the ongoing pandemic based on ai-aided data analysis is particularly important since they are a high-risk group for contracting the covid- disease ( ) and developing later stress-related symptoms. however, the methodology proposed in this article might be applied generally for all those who were exposed to higher levels of such risks during the covid- pandemic. the main objective of the proposed methodology is to expand subjective metrics as predictors of potential mental health disorders mainly specific for phase with more objective metrics derived in phases , , and . the use of neuro-physiological features is expected to provide additional information and increase reliability when identifying particularly at-high-risk individuals. such efforts are well aligned with the growing literature regarding the application of ai methods in prediction of chronic mental health disorders, which has been initially focused mainly on self-report predictor variables ( , , ) but has been subsequently extended to speech features ( ) and various biomarkers ( , , ) . these efforts should help mental health practitioners make their diagnostics more objectively than currently done in the dsm- . acquiring more reliable neuro-psycho-physiological predictors based on objective metrics assessment in early identification of the vulnerable individuals is an important step forward in the 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these threats include fear of the potential for infection by the virus itself; social isolation and alterations in health-related behaviors caused by mitigation measures aimed at reducing viral transmission; financial insecurity secondary to the economic consequences of the pandemic; and disruption of the healthcare system. simply put, this is a disaster with consequences beyond the immediate health impact of the virus. while the covid- pandemic is in many ways unique, unfortunately, disasters and large-scale emergency events happen somewhere in the world each day and typically, there is more than one disaster in the united states nearly every week . research from past large-scale traumas can inform our knowledge of mental health effects, risk and resilience factors, and effective services and interventions, enabling us to anticipate the likely mental health impacts of the current pandemic. this prior research also lays bare what we do not know and sets the research agenda for the national institute of mental health's response to covid- . individuals exposed to a disaster experience a wide range of reactions. in a comprehensive literature review encompassing study samples from different events comprising over , individuals, norris et al. ( ) described the worry, fear, distress, somatic complaints, and sleep difficulty that are common for many people early after exposures to traumatic experiences. of the disasters studied, relatively few samples ( %) showed minimal or highly transient impairment; half of the samples showed moderate impairment; and, the rest showed clinically significant distress ( %) or severe symptoms indicative of a diagnosable psychological disorder ( %). for most individuals exposed to disasters, the initial experience of mild and even significant symptoms tend to improve with time, but a significant minority (~ %) may have longer term or chronic experiences with mental illness . individuals may be at higher risk of chronicity if they have few social supports, a history of prior trauma, a history of mental illness, were exposed directly to deaths or injuries, had severe acute reactions to the disaster, or are experiencing ongoing stressors (including occupational or financial strain) . frontline healthcare workers treating the sick and dying may be at higher risk for experiencing psychiatric morbidity, at least acutely . as with routine stressful and traumatic events, there is no single variable that determines individual outcomes; the additive total of risk and resilience factors will determine how each person will respond . meeting immediate needs may help mitigate some long-term impacts of trauma on mental health. practicing healthy coping strategies (noting accomplishments, setting reasonable expectations, talking, exercising) and avoiding substance abuse also tend to help with recovery. not everyone recovers without intervention. for those who experience new or worsening illness, treatment can help . indeed, promoting mental health recovery with evidence-based screening, assessment, treatment, and care coordination, while expensive, is likely to be cost-effective in the long term. of particular concern with the covid- pandemic are the potential effects of mitigation strategies on mental health. we need to understand the risks and benefits of public health policies and guidelines, and support approaches to increase resilience to their adverse mental health effects. again, past results help inform our expectations. the first severe acute respiratory syndrome (sars) outbreak in - was ultimately contained globally through widespread quarantine measures. during these efforts, longer durations of quarantine were associated with increased reports of distress, as well as symptoms of posttraumatic stress and depression . add to these effects the potential negative impact of the economic distress that has accompanied the widespread shutdowns during covid- , and the consequences for at-risk individuals may be particularly severe. here, a modern, data-focused research strategy has the potential to yield insights based on geographic and jurisdictional variance in recommended mitigation approaches and the public's adherence to them. public and commercial health and administrative databases can be combined with ongoing cohort studies to understand how public health directives, compliance with mitigation measures, and economic sequalae interact with risk and protective factors to alter mental health trajectories. such studies will not only inform our response to covid- , they will also improve preparations for and responses to future pandemics. in the united states, the mental health care system is unable to meet the needs of people with mental illnesses in the best of times . delivering adequate care during disasters and other large-scale traumas is especially challenging. consider the example of hurricane katrina: months after the storm, fewer than % of people who developed mood or anxiety disorders received any care; of those who did, % had discontinued treatment. undertreatment was associated with a number of demographic factors, including age, marital status, racial and ethnic minority status, insurance status, and income. this is the crisis we face. the anticipated surge in demand for mental health care could quickly overwhelm capacity, particularly in specialties (such as child psychiatry) or locales (such as rural areas) where an existing shortage of providers is known. gaps in and barriers to care for many vulnerable populations (including those with serious mental illness, in under-resourced communities, in prison, or who are homeless) are known challenges with unknown solutions. research aimed at discovering solutions to these challenges needs to be prioritized. this research should be focused on leveraging the available mental health workforce, enabling practical, scalable, and sustainable mental health screening and triage, and providing interventions at scale. interventions for treatment of acute illness and prevention of chronicity need to be tested across the lifespan and along a continuum of intensity. technological approaches, including digital and telehealth, will likely be crucial, but additional approaches must also be considered to ensure that interventions can reach those with limited access or familiarity. research to understand and improve engagement and continuity of care, including approaches to facilitate (re)connection to care for persons with serious mental disorders who experience disruption in services, is needed. finally, vulnerable populations, including those with serious mental illness or health disparities, are less likely to engage in mental health care, highlighting the need for innovative approaches. this is the research agenda we are pursuing at nimh in response to the covid- pandemic. we seek to understand the unique aspects of the covid- pandemic, particularly with regard to interactions between risk and resilience factors and mitigation efforts. but even more crucially, we seek to understand how to best utilize current treatments, imperfect as they are, in order to optimize a ready armamentarium that has proven helpful; research is now needed to inform the next steps that will make these treatments widely accessible across cultural, racial, economic, and technological divides. in this way, the mental health research community, working in concert with clinicians and policy makers, can reduce the adverse impacts of the covid- pandemic while developing the evidence base necessary to meet the demands of future disasters. disclosure statement: the authors report no biomedical financial interests or potential conflicts of interest. long-term psychological and occupational effects of providing hospital healthcare during sars outbreak. emerging infectious diseases weighing the costs of disaster: consequences, risks, and resilience in individuals, families, and communities postdisaster psychological intervention since / k promoting mental health recovery after hurricanes katrina and rita arch gen psychiatry sars control and psychological effects of quarantine twelve-month use of mental health services in the united states: results from the national comorbidity survey replication rc disruption of existing mental health treatments and failure to initiate new treatment after hurricane katrina key: cord- - ay authors: ali maher, osama; bellizzi, saverio title: who paradoxes in emergency operations: the dilemma of a un specialized agency date: - - journal: disaster medicine and public health preparedness doi: . /dmp. . sha: doc_id: cord_uid: ay the past two decades have witnessed a major shift in humanitarian operations to respond to more internal conflicts instead of the traditional cross-border wars. over the recent years, two major shifts have taken place within the who to orient toward response to emergencies, namely the introduction of the humanitarian reform and the cluster approach in and the introduction of the emergency response framework (erf). the financing of the agency in humanitarian operations is adding emerging elements to the who operations, especially because of the constantly higher contribution from non-state- and state- funding agencies. pending issues include aspects like health strategy, conflict analysis, legal issues of aid delivery, impartiality in delivering services, and other aspects and needs. t he world health organization (who), according to its constitution, is the global guardian of the public health and the un agency responsible for attainment by all people of the highest possible level of health. technical assistance and "aid" provision is entirely bound by and upon request and approval of governments. the past decades witnessed a major shift in humanitarian operations to respond to more internal conflicts instead of the traditional cross-border wars. it became very complicated to fill the approach drawn by the who constitution. internal conflicts are often characterized by what so-called non-state actors and sometimes militias classified as terrorist organizations. in many cases, these non-state actors/militias are controlling most of the country and its health system for long periods of time. as a global guardian of public health, major shifts took place that still trouble the strategic thinking and the implementation of who operations. the first shift was the introduction of the humanitarian reform and the cluster approach in as the working model for coordination of humanitarian response. the who was assigned the role of global health cluster lead at country and higher level. even though the clusters are meant to be a forum for coordination of work implemented by all actors and, in many cases, led by governments and/or non-state actors, there is an obligation of cluster lead agencies to facilitate neutral leadership. health cluster is no exceptionthe neutrality of who leadership vis-à-vis supporting recognized government, despite their role in management of the country health system, can pose a challenge to the organization. the second important shift was the introduction of the emergency response framework, in the wake of the first ebola outbreak in west africa. the document importance is embedded in the fact that it ends the debate within the agency on whether the agency should be a norms and guidance setting to a fully operational agency in emergencies with a specific set of functions which should be fulfilled from establishing coordination to direct implementation of activities when needed. these shifts imply that the agency is now much more involved in health system management and operations in almost all emergencies globally in different forms and capacities. the financing of the agency in humanitarian operations is adding an emerging element to who operations. when the constitution of the who was presented, the main source of funding to the organization activities was done through the assessed contribution (ac) of the member states (ms). nowadays, the ac by ms represent less than % of the agency funding, which places the agency under the pressure of governments and non-state-and state-funding agencies, potentially pushing the agency away from its role of responding uniquely to governments. the establishment of the world health emergency program was a clear endorsement for the agency to be operational on the ground, with a more concrete basic documents, forty-fifth edition, supplement. constitution of the world health organization (who) inter-agency standing committee. iasc guidance note on using the cluster approach to strengthen humanitarian response world health organization coronavirus (covid- ). the u.s. government and the world health organization the authors have no conflicts of interest to declare. oam and sb contributed equally to conceive the idea and draft the manuscript. key: cord- -ccb coz authors: subiakto, yuli title: aviation medicine capacity on facing biological threat in indonesia airports date: - - journal: infect dis rep doi: . /idr. . sha: doc_id: cord_uid: ccb coz airports need high security procedures, especially for preventing outbreaks of infectious diseases spread by passenger and carried goods. outbreaks of disease form real threat to national defense that can endanger national sovereignty, territorial integrity and national security. biological agents that are dangerous sources of outbreaks infectious diseases can be spread by criminal and terrorists for biological warfare. based on data, the spread of diseases in indonesia came from abroad, such as sars from china, mers-cov from the middle east, avian influenza from china, hiv from africa etc. indonesia has a population of more than million peoples, , islands, and climate conditions that allow microorganisms to grow well. in domestic flights transported , , persons and international flights , , persons, we need to prevent the spread of diseases in indonesia entering through the airports. efforts to prevent the entry of dangerous biological agents in indonesia were carried out by quarantine officers and port health officers. the development of threat outbreak disease in air transportation is real in the future, so all indonesia airports must have action plans to prevent the spread of infectious diseases. the air force must act as guardian of sovereignty by having medical personnel on the spot for role interoperability with the personnel port health office for prevent the entry of dangerous biological agents. capacity building need for be enhanced for prevention, detection, identification and response through a training of the personnel, procurement facilities for readiness prevent, detect and respond when facing biological threat. the threat of an infectious disease outbreak is real threat to indonesia's national defense, because this is considered to endanger national sovereignty, territorial integrity and national security. the inci-dence of diseases outbreaks will increase with conditions of malnutrition, poor sanitation, poor health services, especially during natural and non-natural disasters. conditions that support disease outbreaks make indonesia vulnerable to outbreaks in certain areas, because there are still groups of people who are experiencing malnutrition, low sanitation behavior, and health services that have not been fully covered. in this regard, a comprehensive step is needed to prevent the entry and spread of potential biological agents, and need for steps to prevent, detect and identify, respond, handle the victims and overcome the infectious diseases among humans. as is known, indonesia is hit by all kind of disasters starting from earthquakes, tsunamis, floods, landslides, eruptions, technology failure etc. where such disasters often cause public health problems in form of infectious diseases, especially if the victim does not get good health services, sanitation is not repaired, or environmental damage is not immediately repaired. spread of infectious disease is also helped by indonesia's climate conditions that allow microbes grow and develop easily, so that infectious diseases can spread quickly, with impacts ranging from mild, moderate and severe. in the current global era, air transportation is choice for people for moving fast or transport goods from one place to another quickly, and between regions and countries there are no limits. in addition to providing benefits community, these conditions also have an impact on spread of infectious diseases with both passenger and goods. airports, as a place where people gather, can act as center of spread of disease and can be used as a target of terrorism by using biological agents. so that if not comprehensively anticipated it will pose a threat that if not handled well will lead to consequences that can be detrimental in terms of economy, politics and defense and state security. deliberate and accidental biological threat is using of biological weapons presents a significant challenge to our national security, our population, our agriculture, and the environment. airport is strategic place and potential target for biological threat, because is place where population will meet and travel. that are areas on land and/or flying with certain limits that are used as a place for aircraft landing and taking off, boarding passengers, loading and unloading goods, and intra-and inter-mode transportation, which are equipped with flight safety, security facilities, basic facilities and other supporting facilities. in this regard, it can be stated that airports are a gathering point for people and goods that are vulnerable to spread of diseases which can reduce public health risks. indonesia has a population of around , , persons, it spreads over , islands, and has climatic conditions that make microorganisms grow well. , seeing these conditions in context of moving people and goods more quickly make aircraft needed from city to another city, besides as a country of muslims, umrah and pilgrimage activities continue. airport is strategic installation, where both domestic and international passengers gather, goods, aircraft, ground crew, air crew and other flight equipment that require high security both physical and non-physical. the aviation industry was among the first major industries to define organizational safety, and to embrace risk management systems as an essential component to reduce the frequency and impact of aviation accidents. as showed in table , movement of people through airports domestic flight departure in indonesia in last five years ( - ) increased by . % per year, loading cargo grew by . % on average per year, and loading baggage grew . %. as showed in table , passenger from international flight on average had grown by . % per year, followed by growth of unloading cargo and baggage of . % and . %. in indonesia established a port health office that had inspected . . passenger aircraft, . . persons, of which . pilgrims, and umrah persons per day. the increase in the number of flights carrying humans and goods both domestically and internationally, in addition to providing benefits to the indonesian economy also has the potential for disease transfer, whether carried by passengers or with goods, through cargo or baggage. the number of infection transmissions that occurred across the entire aircraft cabin was strikingly large. infectious diseases and pandemics are primarily spread through aviation as a mode of travel. so we need to take action before creating impacts that can threaten human health in indonesia as a result of the spread of diseases that are not controlled: it is necessary to prevent the spread of diseases through air transportation. base on decree mohroi no. /menkes/per/iv/ , port health office in airport has the task of carrying out prevention of entry and exit of diseases, potential disease outbreaks, epidemiological surveillance, quarantine, control of environmental health impacts, health services, supervision and security of new diseases and re-emerging diseases, bioterrorism, biological elements, chemicals and radiation security in airport areas. port health office was implemented by the international health regulation (ihr- ) for prevention occurrence public health of international concern (pheic) in point of entry. port health office has capacity to reduce public health impacts, especially the spread of infectious diseases. it has carried out vector control guidance, supervised sanitation of transport equipment, improved clean and healthy living behavior and general health and improved occupational safety and health. many biological agents that cause potential outbreaks come from outside of indonesia with newly emerging, reemerging/resurging and delicately emerging species, so that to reach indonesia they require a series of trips that are quite far like sars from china, mers cov, from the middle east, avian influenza from china, hiv from africa etc. based on these incidents, it can be said that airports act as one of the entry points for spread of diseases in indonesia that are spread by passengers and goods contaminated with dangerous biological materials, or deliberately distributed by certain groups to cause fear or threaten state security. the spread of diseases in a country can occur not only from its own agents but also there are several factors that influence it, namely bad sanitation, bad nutrition, presence of diseases, irrational use antibiotic, antibotic uncontrolled distribution, uncovered vaccination and rejected vaccination, bad environmental situations, dis-eases coming from wildlife, terrorism, fast moving personnel from the area to another area, lack of biosafety in livestock. main important properties for biological agent intentional deliberate are route of entry, environmental stability, disease severity, stability against disinfection, ease of large scale production and infectivity. the spread of biological agents in airports that occurs deliberately for the purpose of criminal acts by using a biological agent known as biocrime. biocrimes is activating by using biological agents, for murder, for profit, distribution of fake vaccines or antibiotics. some biocrime activities are attacks on specific ethnic population groups within a country, who are perceived to be opposition to terrorist goals; sabotage of specific food groups, such as contamination of imported food products with toxins, pathogenic bacteria, or poison and attacks directed at one of the country's institutions, agencies, or military departments, a stock market, or a major communications center. biocrime actions carried out through airports that have occurred have been delivery of antibiotics or substandard vaccines for advantages. bioterrorism is intentional use of microorganism or toxin derived from living organism to cause death or disease in humans or the animal and plans. , , , bioterorrism might include such deliberate acts as salad contamination with salmonella, injection of hiv virus, anthrax spread by mail, spreading a virulent disease among animal production facilities, poisoning water, food and blood supplies. use biological agents for threats is becoming increasingly possible for terrorist groups. developing microorganism with increasing lethality for terrorist attacks and the rise of religious terrorism call for political, theological, tactical and strategic disincentive to using as weapons and perpetrating acts of mass destruction. beside that perception use of weapons undermine their political support; motivation religious terrorist for increase threat of mass destruction. , [ ] [ ] [ ] until now, acts of terrorism through airports in indonesia have never happened, but in the future airport can be target of acts of terrorism cause airport is place, when many people from domestic or international gather together for travel. if terrorism attacks happen it will impact reducing international credibility and influence economy, politics, and security conditions. during war use of biological agents is known as biowarfare, which is an action using microorganisms (bacteria, viruses) or toxins found in weapons for war, with the intention of reducing abilities, causing illness, and killing. [ ] [ ] [ ] [ ] [ ] open biological warfare until now has never happened, it is estimated that air transportation is the most effective means for biological warfare. using biological agent intentionally as weapons has advantages: they often are low cost of producing many biological agent, small quantities may have dramatic effects, deadly or incapacitating effect on a susceptible, they are easily disseminated, difficulty in diagnosing index cases, can result in fear, panic and social disruption and symptoms can mimic endemic, naturally occurring disease. [ ] [ ] [ ] [ ] [ ] [ ] some of key factors for pathogenic biological agents being deliberately distributed rise from several considerations: availability of production in sufficient quantity, ability to cause either lethal or incapacitating effects are achievable and deliverable, appropriate particle size in aerosol, ease of dissemination, stability (while maintaining virulence) after production in storage, weapons and environment, victims of nonconsensual performance of friendly forces. countermeasures of spread biological agent are based on characteristic of pathogenicity of the organism, mode of transmission and host range, availability of effective preventive measures and availability of effective treatment. according on global health security countermeasure bio-logical agent spread are prevent, detect, respond and ihr related hazards and point of entry. where prevent and reducing the likelihood of outbreak and other public health hazards and event defined by ihr is essential, detecting the threat early can save lives, while rapid and effective response requires multisectoral, national and international coordination and communication, ihr capacities are required at points of entry and during chemical events and radiation emergencies. indonesia has law to regulate the impact of advances in transportation technology and the era of free trade that could risk causing health problems and new emerging diseases or re-emerging diseases that reappear with faster spread and the potential to cause public health emergency. at present momenti, prevention of infectious diseases in the airport is carried out by the ministry of agriculture or by the quarantine service, passengers who experience illness suspected of contracting an infectious disease are carried out by the port health office, but not all airports have quarantine officers and port health offices. at present based on data from the ministry of health, the international port health office amounts to international airports, so still many airport aren't have port health office. the current condition between health airport and aviation medicine at the tni base is not well established, so that if there is a threat of disease outbreaks coming through the airport and at the airport there is no port health office, there will be a delay in the initial handling of victims. in this regard, role of aviation health, both doctors qualified as flight surgeons and flight nurses in air force bases need to be empowered, so that there is no spread of infectious diseases in the environment. aviation medicine have authority to examine, determine diagnoses, and evaluate the results of pilots' health checks, where the legal product is in the form of aviation health certificate. part of the duties and functions of aviation medicine in air force is providing health support and health services in flight. flights surgeons at air bases have role of carrying out preventive, curative activities on flight crews the role of aviation health in airports in an effort to prevent spread of infectious diseases originating from passengers and goods is to take preventive actions by conducting detection and identification, handling victims and carrying out referral actions. besides that, it cooperates with the occupational health and safety department and conducts checks and prevention. the collective effort is aimed at improving defenses against biological attacks. within these efforts are programs and agencies working towards increasing data collection, analysis, and intelligence gathering. the intelligence is applied to mitigating the effects of bioweapons by developing vaccines, therapeutics, and detection methods to increase the defensive posture, ultimately, biodefense initiatives protect the military forces and citizens from the effects of biological attacks. some steps that must be considered in increasing capacity of aviation medicine in air force, such as institutionalize & build regional and sub-regional mechanisms. the ramp up implementation of international frameworks make timely and relevant policies shifts to the address of disease risk drivers, regular capacity building initiatives with focus on preventing, strengthen surveillance and response, laboratory strengthening and networking, strength risk communication, invest in public health research, and map success stories from the region. aviation medicine in air force is expected to have ability in preventive activities, detection and identification and handling of victims of infectious diseases in the context of overcoming the spread of infectious diseases at airports. preventive epidemics include natural outbreaks and intentional outbrakes or leakage accidents (releases). types of preventive measures include ( ) preventing emergence and spread of antimicrobial drug resistant and emerging zoonotic diseases and governing international regulatory frameworks for food safety. ( ) promoting national biosafety and biosecurity systems and ( ) reducing number and magnitude of infectious disease outbreaks. the strategy for prevention of biological incidents includes strength of biological and toxin weapons convention, control of dual use equipment, improve control of pathogens and genetic material, improve international cooperation, improve scientific research and improve backups, check experts working in class ¾ labs. detection and identification activities carried out by laboratory, military institutions, moh by implementing detect threat early. conduct early detection of threats which include: ( ) launching, strengthening and linking global networks for realtime biosurveillance ( ) emergencies of international concern ( ) developing and deploying novel diagnostics and strengthening laboratory systems ( ) training and deploying workforce effectively for biosurveillance. , response activities were carried out by military hospitals, public hospitals, hospital moh which included decontamination of personnel, equipment (thermos scanner), facilities and infrastructure, health care for victims, responding rapidly and effectively in dealing with biological threats as international attention. ( ) developing an interconnected global network of emergency operations centers and multisectoral responses to biological incidents. encourage the strengthening of emergency operations centers: multisector emergency response teams that are trained, know how to function, have access to real time information systems and capacity to strengthen information on occurrence of outbreaks. ( ) improving global access to medical and non-medical countermeasures during health emergencies. enhancing capacity of aviation medicine in the face of the threat of the spread of dangerous biological agents is by measures on prevention, detection, and response can be done by increasing capacity of personnel and equipment. enhance capacity building ( ) personnel by carrying out procurement, force structure and unit design, ( ) equipment by making systems and equipment (thermos scanner, decontamination), facilities. ( ) readiness by implementing training education, training table top exercise (ttx), field top exercise (ftx) simulation, socialization of code of conduct and operational, equipment maintenance, supply stocks. interoperability beside stage holder national, regional and international to detect and respond biological threat on laboratory collaborating center, quarantine and observation personnel, treatment of the victim. some capacity-building activities that must be increased in stages and are sustainably are training to improve military medicine capacity in dealing with infectious diseases carried out by the ministry of defense and the tni, ministry of health, and ministry of agriculture, ministry of transportation, ministry of law and human right in form exercise are ttx and ftx activities nationally. training in order to increase the ability to overcome infectious disease outbreaks at the asean level and international. the prevailing who recommendations for the contact tracing of air travelers should be modified to include all possible sources of infection. the who should intensify its existing successful collaboration with organizations such as icao, iata, and aci in order to promote procedures for the effective management of highly contagious and life-threatening diseases. airports need high security procedures, especially preventing outbreaks of infectious diseases spread by passenger and carried goods. outbreaks of diseases form real threat to national defense that can endanger national sovereignty, territorial integrity and national security. biological agents are dangerous sources of outbreaks infectious diseases that can be spread by criminal and terrorists with biological warfare intentions. aviation medicine has a strategic role in preventing, mitigating and rehabilitating the threat of dangerous biological agents. increasing role of field health under the air force medicine has an important role in overcoming the threat of hazardous biological agents, role of the hospital as a support to victims in the field, and the role of the air force pharmaceutical institutions in the identification of biological agents. interoperability is needed between air force medicine, port health office, quarantine office, immigration, authority airport to prevent, detect and respond outbreak of disease in airport. increased flight health capacity in the face of threat of spread of biological agents by increasing the number of personnel who have the ability with multilevel and continuous training, fulfillment of facilities and infrastructure which include means of decontamination, prevention, detection and identification and handling of victims, training and operational, equipment maintenance, stock operating costs. peraturan menteri pertahanan ri nomor tahun tentang buku putih pertahanan indonesia undang-undang ri nomor tahun tentang penanggulangan bencana peraturan menteri kesehatan ri nomor: tahun tentang penyelenggaraan pelabuhan dan bandar udara sehat badan pusat statistik-statistic indonesia. statistical yearbook of indonesia air transportation statistics laporan kegiatan kantor kesehatan pelabuhan indonesia tahun pada pertemuan audiensi menteri kesehatan dengan kepala kkp seluruh indonesia screening for infectious disease at international airport : the frankfurt model peraturan menteri kesehatan nomor: /menkes/per/iv/ tentang organisasi dan tata keja kantor kesehatan pelabuhan responding to infectious disease outbreaks. nih cbrn protection: managing of threat of chemical, biological, radiological and nuclear weapons containing and preventing bilogical threats the changing face of terorrism: how real is the threat from biological, chemical and nuclear weapons biological weapons: recognizing, understanding and responding to the threat biological, chemical, and radiological terrorism, emergency preparedness and response for the primary care physician an overview on biological weapons and bioterorrism joint external evaluation tool: international health regulation undang undang ri nomor tahun tentang kekarantinaan kesehatan peran dokter penerbangan dalam pelaksanaan kewajiban pemeriksaan kesehatan bagi penerbang untuk keselamatan penerbangan, soepra biological incident operation: a guide for law enforcement laboratory biorisk management: biosafety and biosecurity key: cord- -jw ye authors: méndez, claudio a.; greer, scott l.; mckee, martin title: the crisis in chile: fundamental change needed, not just technical fixes to the health system date: - - journal: j public health policy doi: . /s - - - sha: doc_id: cord_uid: jw ye chile has been viewed as an exemplar of social and economic progress in latin america, with its health system attracting considerable attention. eruption of widespread civil disorder marred this image in . we trace the evolution of chilean health policy and place it in context with developments in other sectors, pensions and education. we argue that much has been achieved, but further progress will necessitate politicians tackling the enduring power of elites that has prevented reform of a two-tier system enshrined in policies of the dictatorship. subsequent analysis showed no improved educational standards but an increase in social stratification [ ] . the pinochet regime did not change the health system initially, though it progressively cut funding. then in it replaced the servicio nacional de salud with the sistema nacional de servicios de salud, and replaced a health fund, the servicio médico nacional de empleados (sermena) with a new one, the fondo nacional de salud (fonasa). employees contributed % of their gross income. the fund also covered unemployed persons and certain pensioners. but, as with schools, chileans could, and the regime encouraged them to, opt out and obtain coverage from a highly subsidized network of private insurers, the instituciones de salud previsional (isapre). isapre provided access to private facilities, thereby creating a two-tier health system. these were much more expensive and were seen as of higher quality than those affiliated to the fonasa system [ ] . next came a transition to democracy with a succession of governments from the center-right, initially (patricio aylwin, - and eduardo frei, son of the previous president, - ) and later the center-left (ricardo lagos, - and michel bachelet, . they implemented reforms, including of taxation and social welfare. president bachelet reformed pensions in the late s to help the poorest % of the population. the reformed pensions did not depend on contribution history, but left core elements of the privatized scheme in place [ ] . education policies from the dictatorship also persisted despite a "penguin revolution", when high school students revolted against the segregation of public and private schools and a revolt by university students demanding an end to the free-market approach to education [ ] . in the health sector, president lagos seemed to make substantive reforms in plan auge, enacted in . this required timely access to high-quality health care by public and private providers, along with financial protection, for a list of health conditions [ ] [ ] [ ] . the initial list of health conditions expanded incrementally to the current . president sebastián piñera announced inclusion of another at the onset of the crisis of . but he also left in place the inherited structures. he did not tackle widespread co-payments required of all except some groups (such as the unemployed, fonasa groups a and b). all others [isapres and fonasa (groups c and d)] pay from to % of the total price of services [ ] . the continued strength of conservative forces and, especially the military in the early years of democratic governments, represented a political consensus favoring minimal reforms without dismantling fundamental power structures [ ] . protests, which by of july were no longer on the streets but had merged into popular criticism of the government's pandemic response, began on october when students jumped turnstiles in the santiago subway system to protest against a chilean peso (approximately us cents) fare increase during peak hours [ ] . the increase was small but imposed during growing discontent with overcrowded carriages and already high fares [ ] . protests soon escalated. large crowds gathered in peaceful rallies to demand major changes to social protection policies including pensions, education, and health. then violence erupted; the police were unable to control the situation, despite deploying considerable violence themselves. the government declared a state of emergency on october , giving the armed forces responsibility to restore order in the capital [ ] . the use of troops evoked the history of brutality by the chilean dictatorship. deploying the military did not restore calm. on saturday, october , the general in command declared a curfew from pm to am, the first during democratic rule in chile [ ] . violence, including human rights violations, mushroomed [ ] . on october, president sebastián piñera responded to growing demands with an "agenda social" (social agenda), measures to alleviate concerns about the health system including a ceiling on out-of-pocket spending, an insurance plan to cover drugs, and an agreement between the central nacional de abastecimiento (national centre for supply) and the most important private drugstore companies to reduce the price of medicines for those who obtained health care from public providers [ ] . despite this "agenda social", peaceful rallies and violent protests continued, now nationwide. on november representatives of almost all chile's political parties represented in the bicameral congress signed the agreement for peace and a new political constitution. it includes provisions for referenda, a first scheduled for april -then postponed to october because of the covid- pandemic. it will ask chileans if they agree to creation of a new constitution; and if so, who should prepare it? a new constitution would replace the one left by the pinochet regime, which prioritized a market economy over social protection [ ] . piñera's government simultaneously escalated repressive measures. on and november , amnesty international and human rights watch published reports on human rights violations in chile since the start of civil disorder. both reports included evidence of excessive force by police during protests-including use of shotguns loaded with rubber pellets blamed for more than eyes injuries [ , ] . the inter-american commission for human rights and united nations human rights office recommended changes to police practices [ , ] . chile had been making progress economically and socially despite the lack of fundamental reforms. that is why the eruption of widespread public discontent surprised many. chile boasts the highest per capita global domestic product (gdp) in south america, and, in , was the first country from that continent to join the organization for economic cooperation and development (oecd). social progress was especially apparent in the health sector. in , the world health report described chile as an "in the right way country", highlighting its progress to universal health coverage (uhc) [ ] . early analyses of implementation of the plan auge, intended to improve access to facilities near peoples' homes, reduced waiting times, improved quality, and caps on co-payments (maximum % of the price and no more than one month's family income for the family in a year), reported a % an increase in use of health services for conditions such as type diabetes and hypertension [ ] and improved survival after acute myocardial infarctions [ ] . president michelle bachelet extended health coverage further during her second term, enacting the ley ricarte soto. it established financial protection system for high-cost diagnostics and treatments, not previously covered, and diagnostic investigations and treatments for oncological, immunological, and rare diseases [ ] . the law also established a commission to set priorities. it was made up of two members of patient organizations and twelve renowned specialists in public health, medicine, bioethics, economy, health law, and drugs named by the ministry of health [ ] . while attribution of changes in health outcomes to a particular policy is always difficult, there are signs that these policies have improved access to health care facilities. the health access and quality index, part of the global burden of disease program, measures deaths that should not occur with timely and effective care, adjusted for the risk profile of the population [ ] . despite starting at similar levels, chile pulled ahead of argentina and uruguay after . use of health services for conditions covered by auge increased, in some cases dramatically [ ] . health reform has been a high priority for chile's leaders in since pinochet's rule. wide inequalities remain and benefits from reform have flowed unevenly to groups in the population [ ] [ ] [ ] . vásquez and colleagues showed that service utilization increased for all groups and inequalities narrowed, but by a pro-rich pattern of consultations with dentists, specialists, and other physicians persisted [ ] , findings that are supported by research on measures such as specialty visits, laboratory tests, and hospitalization. all demonstrate concentration of utilization by the most affluent households, and of emergency visits by those with fewest resources [ , ] . patients report continuing barriers to care, especially co-payments. out-ofpocket spending is high by oecd standards [ ] and many households experience catastrophic costs [ ] . in chile´s health expenditure per capita was us$ , one of the lowest among oecd countries; it has grown rapidly, at a rate among the highest of oecd countries [ ] . as a percentage of gdp, spending increased from . in to . in [ ] . polling reveals persisting disaffection with health care [ , ] . wide inequalities persist in availability, affordability, and utilization of health services [ ] [ ] [ ] . death rates among those waiting for treatment of conditions not covered by auge have increased [ ] . chile's economic system has made it one of the most economically unequal countries in the world, with a gini coefficient of . [ ] . wealth inequality is harder to measure [ ] but seems to be even higher, with the share of gdp owned by billionaires the highest in the world (excluding tax havens) [ ] . the commitment of successive chilean governments to implement change is not in doubt but they have been unable to make major changes to the two-tier system created by the dictatorship [ ] . in the health sector, powerful private insurers remain unscathed [ ] . silva argued that a coalition of business leaders and landowners influenced policies of the pinochet regime and their power persisted after the democratic transition. the legacy amounts to an implicit agreement between them and subsequent governments to permit democracy, but without challenging much of the status quo [ ] . chile is not unique in this; elsewhere fundamental political and economic reforms have left existing power relationships largely intact. notable examples include the transition from communism in europe, where many of the previous leaders transformed overnight into "democrats" [ ] and the rapid recovery of slave owning families in the confederate states after the american civil war [ ] . acemoglu and robinson developed an equilibrium model to explain this, in which they distinguish the "elite" from the "citizens". the former hold de facto power even though the latter have de jure power [ ] . they show that changes in de jure power, such as those brought about by a transition to democracy, can be offset by changes in de facto power, especially where the stakes are high for elites. the italian writer giuseppe tomasi di lampedusa, in his novel the leopard, described an aristocratic sicilian family finding ways to retain influence during the italian risorgimento, delivering the famous quotation: "everything must change so that everything can stay the same" [ ] . on the surface, everything has changed in chile. but as to the distribution of power, everything has stayed the same. the recent crisis drew attention to weaknesses in the health system but, if our analysis is correct, to be effective the response will not just be a technical fix but a fundamental reassessment. recently, crispi and colleagues wrote: "chile must decide if the time has come for a profound structural change, based on a different set of political and ethical principles" [ ] . we agree. the end of transition? chile the chilean left in power national health systems of the world: volume the countries the political realities of health in a developing nation salvador allende: physician, socialist, populist, and president changes in health financing: the chilean experience the shock doctrine from chicago to santiago: neoliberalism and social security privatization in chile the chilean pension system at years: the evolution of a revolution chile's, "neoliberal" retirement system? concentration, competition, and economic predation in "private" pensions chile's private pension system at : impact and lessons the effects of generalized school choice on achievement and stratification: evidence from chile's voucher program neoliberal reforms in health systems and the construction of long-lasting inequalities in health care: a case study from chile. health policy you win some, you lose some: pension reform in bachelet's first and second administrations neoliberal education and student movements in chile: inequalities and malaise innovation and change in the chilean health system health care privatization in latin america: comparing divergent privatization approaches in chile, colombia, and mexico rights and duties policy implementation in chile: health-care professionals' perceptions health benefits guarantees in latin america: equity and quasimarket restructuring at the beginning of the millennium mexico: cepal public education and student movements: the chilean rebellion under a neoliberal experiment chile's riots: frustration at the gate of the promised land americas quarterly why chile's massive protests started with the metro chile, a deadly weekend of arson, riots and armed forces as discontent rises. nbc news chile army declares curfew, president reverses fare hikes after unrest. reuters hundreds shot and beaten as chile takes to the streets. the guardian violent protests in chile linked to health-care inequities the constitution of the dictatorship has died': chile agrees deal on reform vote the guardian chile: deliberate policy to injure protesters points to responsibility of those in command chile: police reforms needed in the wake of protests commission on human rights. iachr condemns the excessive use of force during social protests in chile, expresses its grave concern at the high number of reported human rights violations, and rejects all forms of violence united nations human rights. un human rights office report on chile crisis describes multiple police violations and calls for reforms: united nations world health organization. the world health report. health systems financing: the path to universal health coverage. geneva: world health organization after chile's health reform: increase in coverage and access, decline in hospitalization and death rates effective universal health coverage and improved -year survival after acute myocardial infarction: the chilean experience challenges in priority setting from a legal perspective in brazil measuring performance on the healthcare access and quality index for countries and territories and selected subnational locations: a systematic analysis from the global burden of disease study health equity in an unequal country: the use of medical services in chile income-related inequality in health and health care utilization in chile health in chile: is the government doing everything it can to achieve social justice? med law equity in health care utilization in chile health outcomes, utilization, and equity in chile: an evolution from to and the effects of the last health reform inequality and inequity in the use of medical services in chile, by age group out-of-pocket health expenditure differences in chile: insurance performance or selection? out-of-pocket expenditure and financial protection in the chilean health care system: a systematic review health expenditure and financing what is driving people's dissatisfaction with their own health care in latin american countries? health expect democratic survival and weakness achieving effective universal health coverage with equity: evidence from chile health equity in an unequal country: the use of medical services in chile inequalities in access to health care for people with disabilities in chile: the limits of universal health coverage prolonged wait time is associated with increased mortality for chilean waiting list patients with non-prioritized conditions linking economic complexity, institutions, and income inequality wealth iniequality and democracy top incomes in chile: a historical perspective on income inequality health policy in the concertacion era ( - ): reforms the chilean way the state and capital in chile: business elites, technocrats, and market economics. london: routledge the persistence of postcommunist elites the intergenerational effects of a large wealth shock: white southerners after the civil war persistence of power, elites, and institutions the leopard. london: pantheon rebuilding the broken health contract in chile key: cord- - lu z authors: ennals, richard title: a strategic health initiative: context for coronavirus date: - - journal: ai soc doi: . /s - - - sha: doc_id: cord_uid: lu z nan the current coronavirus pandemic is a disruptive event, a global "kodak moment" (johnsen et al ). life will not be the same again. this does not mean that there had been no previous warnings. we now need to think about ways forward after the pandemic. back in september , at a conference in brighton hosted by the ai&society editor, karamjit gill, on "artificial intelligence for society", we discussed ways forward in our field. i was working at imperial college and in the uk alvey directorate, designing and managing research and development in advanced it. i outlined a suggested "strategic health initiative", which was published in ai for society (ennals b) , and in star wars: a question of initiative (ennals a) . over the last years, there have of course been many major technological advances. however, i suggest that the principles set out in the paper remain valid for the new context in march . the strategic health initiative in argued for drawing on progress in medical science, advanced computing and social administration. it was then held that success would have enormous potential benefits, not only for the health of the nation, but also for the economy. improved health and medical services would provide considerable financial benefits, as would the development of a better trained workforce. it would have direct effects on the whole population, bringing them into contact with computer technology in a benevolent context, reducing the division into two nations of "haves" and "have nots" with respect to health and computer literacy. the health of individuals is seen as integral to the health of the nation. illness is not a crime to be punished by financial penalties, and information concerning the restoration of health should be freely available in accessible terms. reflecting back on the intiative, one significant area for the application of advanced technology was identified as the health service. at the time of its establishment in , the national health service (nhs) was a model for international health care provision, and a central part of the policy of a government which was concerned to strengthen its people after suffering and war, seeing such provision as an essential investment. the nhs has since suffered from government neglect, with funding failing to match needs, and hospitals not being equipped with the same level of technology that should be standard in other advanced countries. it has become regarded all too often as an optional expense, increasingly to be devolved to the individual or the "community", where the financial resources required for work with advanced technology are not available. even now in , this health care deficit sounds familiar. i argued then that prevention may be better than cure, but that the system of financial incentives is biased towards cure. in these dire times of the coronavirus, i wonder what has changed. in , i noted that where known enemy diseases threaten, our detection equipment is out of order. straightforward tests were available for many forms of cancer, yet general scanning was not carried out on grounds of cost, and where intelligence of invasive disease had been acquired, all too often it was not transmitted to the individuals concerned. the computer systems capable of managing the information existed, but the funds were not provided to pay for them. we had the necessary technology for much of this work, but we lacked the political will to apply it. to quote ian lloyd mp, "we have found the enemy, and he is us". our front line medical troops were pitifully resourced, and were made to work inordinate hours in the medical trenches with substandard weapons. patients had to be turned away from hightechnology treatment in the cause of economy. intensive care facilities were kept in mothballs. with changes in cleaning and catering arrangements, hospitals might not be healthy places to be if you were ill. patients would rather not be ill, and, if ill, would rather not trouble the doctor. civil defence advice is needed for patients in their homes, and in diagnosing the source of attacks of headache or nausea, preventive measures to enable them to take evasive action, getting out of the line of fire of heart disease, cancer or cirrhosis of the liver. "protect and survive" should be the watchword for the citizen in the blasted wasteland of community medicine. often we have the resources available to repel an attack from outside, but they are not sufficiently organised. doctors need decision support as they seek to define a strategy with a particular patient and crisis management tools as numerous complaints emerge, or as competing demands are made for scarce resources. increasingly they need a mastery of the official rules and regulations (on, e.g. the prescription of certain drugs and their generic substitutes) and an encyclopaedic knowledge of drugs and their interactions. they need to be able to explain their diagnoses and treatment in appropriate language, based on a model of the level of knowledge of patients and their families, and to draw on the experience of others. in the community medicine field, whether of barefoot doctors or a team of mobile professionals, information needs to be assembled, available and explicable. advanced medical teamwork requires advanced information technology if the varied knowledge of the interdisciplinary team is to be brought to bear on shared problems. even in those early days of , it was clear to me that with the advent of artificial intelligence techniques, further advances are made possible. artificial intelligence is concerned with the study of human thinking, and its modelling in computer programs. we can learn about particular problems by attempting to model them, and the consequent programs can be of use in helping people to solve such problems themselves. early work has been done in psychiatry and psychotherapy, and in problems of vision and speech, which shows the potential for further work. military funding has gone into systems for voice and speech recognition, and for message understanding. an application focus in the field of intensive medical care or care of the multiply handicapped could be extremely beneficial, using, for example, speech-driven workstations as were developed on an alvey large demonstrator project. the strategic health initiative of argued that if such a programme was successful, the strategic results for the country could be spectacular. we could expect an improvement in the health of the population, with a cost-effective change of emphasis to prevention rather than cure, and a fall in the number of working days lost each year through illness. the research community could benefit from the motivation of work in "advanced technology with a human face". intelligent computer technology places a new burden on us to determine the kind of society in which we choose to live. it assumes the form laid down by its masters. as in , i still believe that researchers prefer to work on projects they believe in. their brains cannot simply be hired for whatever purpose. although in the age of machine learning and deep learning, ai scientists may be able to command astronomical salaries for being transferred between research centres like football stars, we still find skilled researchers who are dedicated to the development of socially responsive ai systems and tools for health and welfare of people. their choice of where to work need not be determined by money: after years of neglect they are suddenly in a new position of power where they can refuse work which they find ethically unacceptable. they can choose instead to focus on fundamental research effort on attempting to solve human problems. in this spirit, we again suggest an initiative to tap this supply of idealism. we need a strategic focus for the next stage of development of an infant generation of technology, to the benefit of society in general: a strategic health initiative. if we abdicate from participation in the decisions as to how the technology is to be used, we must accept responsibility for what follows. i close with the words of lord beveridge, whose work laid the foundations of the british welfare state, including the national health service. "the object of the government in peace and in war is not the glory of rulers or of races, but the happiness of the common man. " beveridge report curmudgeon corner curmudgeon corner is a short opinionated column on trends in technology, arts, science and society, commenting on issues of concern to the research community and wider society. whilst the drive for super-human intelligence promotes potential benefits to wider society, it also raises deep concerns of existential risk, thereby highlighting the need for an ongoing conversation between technology and society. at the core of curmudgeon concern is the question: what is it to be human in the age of the ai machine? -editor. beveridge report: social insurance and allied services a way forward for advanced information technology: shi-a strategic health initiative a way forward for advanced information technology: shi-a strategic health initiative coping with the future: rethinking assumptions for society, business and work key: cord- - fe aeb authors: mann, robert h; clift, bryan c; boykoff, jules; bekker, sheree title: athletes as community; athletes in community: covid- , sporting mega-events and athlete health protection date: - - journal: br j sports med doi: . /bjsports- - sha: doc_id: cord_uid: fe aeb nan robert h mann , bryan c clift, jules boykoff, sheree bekker 'this is far bigger than our dreams right now. now more than ever is a time to think bigger than yourself. protect yourself, your families and your communities'. melissa bishop-nriagu (canadian m record holder). the current coronavirus (covid- ) pandemic presents an extraordinary public health challenge. the who defines a pandemic as the global spread of a new disease for which there is little or no preexisting immunity in the human population. worldwide, we have seen ambitious public health measures implemented by governments, non-governmental organisations and individuals alike. yet, there is still more to be done to 'flatten the curve' and mitigate the impact of this pandemic. sporting 'mega-events' are international, out of the ordinary and generally large in composition. these include the olympic games, which provide massspectacle for the public while producing significant health and socioeconomic impacts for host nation(s), including an increased risk for transmission of infectious diseases. therefore, pandemics like covid- bring added urgency to examine the impacts of hosting sporting mega-events. as sporting mega-events have been cancelled and postponed in response to covid- , the rhetoric emerging from international sporting organisations, such as the international olympic committee (ioc), has emphasised the importance of protecting athlete health. while this messaging around the decision to postpone tokyo aligns with the olympic charter, and complements the ioc's investment in athlete health protection, it is necessary to interrogate what the unintended impacts are for athletes and others in relation to the cancellation, postponement or continuation of staging sporting mega-events in the moment, and aftermath, of a communicable pandemic. the current covid- crisis spotlights the need to create and codify a rigorous system of checks and balances that ensures greater accountability on the part of megaevent organisers, while ensuring that the athletes' voice is heard. in observing early decision-making processes during the current pandemic that proposed that mega-sporting events continue as planned, a tension emerged between maintaining 'athlete as commodity' within a lucrative commercial industry, while recognising and promoting 'athlete as community' in a world that requires social cooperation to mitigate the impact of covid- . in the case of the tokyo olympics, an upsurge in athletes speaking out, such as melissa bishop-nriagu, and action taken by athlete associations and national olympic committees, instigated by canada, clearly prompted the ioc's decision to postpone. complex social systems: recognising athletes as community the cancellation or postponement of sporting mega-events comprise a clear effort to safeguard athlete health. given the current situation, any other course of action would be contrary to public health measures. yet, the disproportionate focus on the health protection of individual athletes has sidelined a larger and more pressing conversation: that of athletes as being situated in wider communities. in sports injury prevention it has become common to reference biopsychosocial models and complex systems in athlete health protection work, yet the underpinning frame of reference still seems to be on individuals, rather than communities. given the current moment-a worldwide pandemic-it has never been more important to recognise, hold space for and negotiate the complex social systems of which athletes are a part. this lens is particularly important to consider. public health centres on the recognition that individual athletes are situated in-and are integral parts of-wider communities that include other athletes, their multidisciplinary support teams, families and local/national/international societies. flattening the curve of a pandemic depends on recognising that a single athlete can be a vector for this communicable disease (and preventing that), but also that their role within their own complex social systems matters. prevention here is bigger than individual athletes alone. recognising, holding space for and negotiating athletes as community-as human beings who are part of this world rather than simply being commodities-has never been more important. by its very nature, elite sport is not equitable. every athlete has a career trajectory that requires navigating several barriers to and facilitators of performance, with only one athlete (or team) standing on top of the olympic podium at the end of each quadrennial cycle. however, in the aftermath of a communicable pandemic, these inequalities will become more apparent and dependent on different public health responses-representative of an international postcode lottery. given that elite athletes will periodise their training programmes towards sporting megaevents, which thus requires access to specialist facilities and multidisciplinary support teams, how can these different approaches be taken into consideration for postponed events? simply moving the timeline may not be enough. indeed, a recent editorial advocated that 'maximal caution' should be taken in resuming sporting activity. these considerations matter, and returning to sport will thus be about more than the resumption of training schedules and a revamped sports calendar. sporting mega-events can provide hope and unity. amid an extraordinary public health challenge, optimism and solidarity matter more than ever. we don't know what a return to sport will look like after this pandemic; however, we do already editorial know that the community matters more than ever. athletes are demonstrating that 'social distancing' is a misnomer: in their insistence to physically distance, and encourage others to do so, they show remarkable social interconnection. taking this physically isolating moment to reflect on athletes as whole human beings, situated in communities that they care about, enables us to adopt more of an athlete-centred approach to athlete health protection when we return to sporting mega-events in the future. the fierce urgency of this task has never been clearer. twitter robert h mann @robert_mann_, bryan c clift @@bryancclift, jules boykoff @@julesboykoff and sheree bekker @@shereebekker contributors rm, sb and bc were responsible for the initial concept. rm wrote the first draft of the manuscript, with sb and bc making initial revisions. all other revisions by rm were circulated and commented on by sb, bc and jb. all authors read and approved the final manuscript. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. mega-event cities: urban legacies of global sports events national identity and global sports events: culture, politics and spectacle in the olympics and football world cup the health and socioeconomic impacts of major multisport events: systematic review olympic and paralympic games: public health surveillance and epidemiology the ioc centres of excellence bring prevention to sports medicine the olympics teeter on the brink how will country-based mitigation measures influence the course of the covid- epidemic? football cannot restart soon during the covid- emergency! a critical perspective from the italian experience and a call for action competing interests none declared. patient consent for publication not required.provenance and peer review not commissioned; internally peer reviewed.this article is made freely available for use in accordance with bmj's website terms and conditions for the duration of the covid- pandemic or until otherwise determined by bmj. you may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. key: cord- -tnde jp authors: jewell, jennifer s; farewell, charlotte v; welton-mitchell, courtney; lee-winn, angela; walls, jessica; leiferman, jenn a title: mental health during the covid- pandemic in the united states: online survey date: - - journal: jmir form res doi: . / sha: doc_id: cord_uid: tnde jp background: the covid- pandemic has had numerous worldwide effects. in the united states, there have been . million cases and nearly , deaths as of october , . based on previous studies of mental health during outbreaks, the mental health of the population will be negatively affected in the aftermath of this pandemic. the long-term nature of this pandemic may lead to unforeseen mental health outcomes and/or unexpected relationships between demographic factors and mental health outcomes. objective: this research focused on assessing the mental health status of adults in the united states during the early weeks of an unfolding pandemic. methods: data was collected from english-speaking adults from early april to early june using an online survey. the final convenience sample included us residents. the -item survey consisted of demographic questions, mental health and well-being measures, a coping mechanisms checklist, and questions about covid- –specific concerns. hierarchical multivariable logistic regression was used to explore associations among demographic variables and mental health outcomes. hierarchical linear regression was conducted to examine associations among demographic variables, covid- –specific concerns, and mental health and well-being outcomes. results: approximately % ( / ) of the us sample was aged ≥ years. most of the sample was white ( / , %), non-hispanic ( / , %), and female ( / , %). participants reported high rates of depression ( / , %), anxiety ( / , %), and stress ( / , %). older individuals were less likely to report depressive symptomology (or . , p<. ) and anxiety symptomology (or . , p<. ); in addition, they had lower stress scores (– . points, se . , p<. ) and increased well-being scores ( . points, se . , p<. ). individuals who were no longer working due to covid- were . times more likely to report symptoms of depression (p=. ), had a . -point increase in stress (se . , p=. ), and a . -point decrease in well-being scores (se . , p=. ) compared to individuals who were working remotely before and after covid- . individuals who had partial or no insurance coverage were - times more likely to report depressive symptomology compared to individuals with full coverage (p=. and p=. , respectively). individuals who were on medicare/medicaid and individuals with no coverage were . and . times more likely to report moderate or severe anxiety, respectively (p=. and p=. , respectively). financial and food access concerns were significantly and positively related to depression, anxiety, and stress (all p<. ), and significantly negatively related to well-being (both p<. ). economy, illness, and death concerns were significantly positively related to overall stress scores (all p<. ). conclusions: our findings suggest that many us residents are experiencing high stress, depressive, and anxiety symptomatology, especially those who are underinsured, uninsured, or unemployed. longitudinal investigation of these variables is recommended. health practitioners may provide opportunities to allay concerns or offer coping techniques to individuals in need of mental health care. these messages should be shared in person and through practice websites and social media. the covid- pandemic has produced over million confirmed cases and over . million confirmed deaths worldwide as of october , [ ] . of these, nearly . million cases are in the united states, with nearly , deaths [ ] . in addition to health impacts, many have raised the alarm about the potential for a widespread global mental health crisis as a result of the pandemic [ ] [ ] [ ] [ ] . specific groups may be at increased risk for adverse mental health outcomes, such as frontline health care workers [ ] and those that have experienced illness or death of family, friends, or coworkers. many more are likely to experience distress as a result of economic hardship, disruption to social networks, and work-and school-related changes due to the protracted crisis. elevated rates of depression and anxiety have been documented following stressors such as disease outbreaks, including the - ebola crisis in west africa, among caretakers, survivors, their immediate contacts, and others [ , ] . in addition, epidemics such as sars and hiv have been associated with depression and other mental health concerns among various groups [ ] [ ] [ ] [ ] [ ] [ ] . the current pandemic is likely to be associated with similar mental health outcomes, as a result of potential exposure to stressors including loss of loved ones, economic hardship, social isolation, and childcare responsibilities following school and day care closures. countless businesses across the united states closed in an attempt to protect workers, limit transmission of the coronavirus, and allow health care systems to keep pace with the needs of those requiring hospital care. with the exception of essential services, much of the economy has come to a virtual standstill, resulting in unprecedented rates of unemployment [ ] . financial struggles, including job loss and food insecurity, are known risk factors for mental illness, particularly anxiety, depression, and suicide [ , ] . in most us states, nonessential workers have been required to stay at home for several weeks. many states have had stay-at-home orders in place for longer periods of time. although there is an easing of movement restrictions in some areas within the united states, many people are still concerned about the potential safety risks of resuming prepandemic levels and types of activities. as a result, so-called "social distancing" continues for many in the united states. physical distancing requirements (eg, social distancing) have the potential to limit physical and social contact, disrupt prepandemic social networks, and undermine the potential for social support at a time when it may be needed most. this may result in an increase in loneliness and social isolation. across numerous studies, social isolation has been associated with increased morbidity and mortality, with an increase in coronary heart disease, stroke, and poor mental health outcomes such as depression and anxiety [ ] [ ] [ ] [ ] [ ] . the increase in financial and familial struggles for some families may have exacerbated the negative effects of strict social distancing measures and overall trauma. although studies examining the mental health impacts of covid- are limited, findings from a few recent studies indicate that many in the united states are experiencing significant and worsening mental health difficulties during the pandemic [ ] . a review of the emerging literature regarding the effects of the pandemic suggests that symptoms of anxiety and depression are common [ ] . in one study [ ] , which used a representative sample and compared recent mental health concerns to those in , large increases in mental health distress were noted. younger people, those with children in the household, married individuals, and asians appeared to be faring worse than others [ ] . authors suggested these findings may reflect economic hardship, but more research is needed to understand factors contributing to greater difficulties in some groups than others. the current study examines demographic differences in mental health and well-being outcomes and specific sources of concern that impact these outcomes among a us sample of adults surveyed between april and june , , immediately following business closures and movement restrictions. this study may bring to light additional factors related to mental health during the pandemic and fill gaps in the current literature. specifically, several covid- -specific concern-related items that have not been previously assessed were included in the current analyses. these findings have the potential to inform current intervention efforts as well as new initiatives, with the potential to mitigate suffering and bolster resilience during the ongoing pandemic. the mental health and wellbeing survey during covid- pandemic received ethical approval from the colorado multiple institutional review board (comirb protocol # - ). survey data was collected between april and june , . a snowball sampling technique was used. this survey was advertised on facebook and instagram via paid targeted advertising. in addition, it was sent out via listservs and other media including centers for disease control and prevention (cdc) prevention research centers, american public health association mental health section, colorado public radio, university of colorado research announcements, and the university of south florida. study data were collected and managed using redcap electronic data capture tools hosted at the university of colorado [ ] . redcap (research electronic data capture) is a secure, web-based application designed to support data capture for research studies, providing the following features: ( ) an intuitive interface for validated data entry, ( ) audit trails for tracking data manipulation and export procedures, ( ) automated export procedures for seamless data downloads to common statistical packages, and ( ) procedures for importing data from external sources. participants consented digitally before beginning the survey. additionally, participants in the initial survey were given the opportunity to opt in to future surveys to collect longitudinal data. a participation incentive in the form of a drawing for one of two $ gift cards was offered. adults aged ≥ years were eligible to take the english-language survey, regardless of country of residence. there were no exclusion criteria beyond ability to provide consent. although data was collected from an international sample initially, most of the participants were residing in the united states. as a result, only data from the us subsample is included in the present analyses. the final us sample consisted of individuals. the -item survey consisted of demographic questions, mental health and well-being measures, coping mechanisms, and questions gauging covid- -specific concerns. demographic questions included age, race/ethnicity, gender, work status, household size, and insurance coverage. the survey also included four mental health and well-being scales measuring well-being, depression, anxiety, and stress. the short warwick-edinburgh mental wellbeing scale (swemwbs) was used as a continuous measure of well-being. it has high internal consistency and convergent validity with other measures of life satisfaction and physical and mental health (α=. in this sample). the swemwbs has a range of - , with higher scores indicating higher well-being [ ] . the patient health questionnaire- (phq- ) was used as a brief measure of depression (α=. in this sample). the phq- has a sensitivity of % and a specificity of % for major depression. the phq- has a range of - and was dichotomized for analyses using a cutoff score of ≥ [ , ] . generalized anxiety disorder (gad) was assessed using the gad- , which has a sensitivity of % and a specificity of % (α=. in this sample). the gad- has a range of - , and moderate or severe anxiety was based on a cut-off of ≥ [ ] . lastly, stress was assessed using a validated -item continuous measure with response options ranging from "not at all" to "very much" stress "these days" (elo stress-symptoms item). this stress item has demonstrated construct, content, and criterion validity for group-level analysis [ ] . the survey included a coping checklist, comprised of behavioral items with an additional "other" option, to ascertain which types of coping were most common (eg, exercise, engaging with media, engaging remotely with family/friends). the survey items examining covid- -specific concerns included questions about personal financial impact, food security, economic impact, and risk of serious illness or death (in participants or others known to participants) related to covid- . questions were phrased in the following manner: "how concerned are you about... [the financial impact current events may have on your family]?" data were exported from redcap into spss (version ; ibm corp) for analyses. data cleaning included testing of assumptions, exploration of outliers, and missingness for all key variables. as all key variables had less than % missing data and data were missing completely at random (χ = . , p=. ), listwise deletion was used in all analyses. univariate and bivariate analyses were conducted. two proportion z tests were also used to calculate differences between responses (%) to the phq- and gad- and national prevalence data. an independent sample t test was run to compare the sample average for the warwick wellbeing score with a nationally representative sample. two hierarchical multivariable logistic regression models were run (logistic regression models and ) to explore associations among demographic variables, depression (not depressed versus depressed), and anxiety (no or mild anxiety versus moderate or severe anxiety) outcomes. hierarchical regression was used to investigate if specific sources of concern (eg, financial concern, illness-related concern) were related to the outcome measures after controlling for demographic characteristics of the analytical sample. for categorical variables, well-established cutoffs based on representative us samples were used. all demographic variables were added simultaneously to each model, after which unique sources of concern were entered into models (logistic regression models and ) to see which sources of concern predicted depression and anxiety outcomes after controlling for demographics. r values, odds ratios, and p values for logistic regression models are presented. next, two hierarchical linear regression models were run (linear regression models and ) to explore associations between demographic variables and stress and well-being outcomes. in total, unique sources of concern were entered into models (linear regression models and ) to see which sources of concern predicted stress and well-being outcomes after controlling for demographics. unstandardized coefficients, p values, and adjusted r values are reported for all linear regression models. alpha (α) was set at . . linear regression models for the well-being and stress outcomes are presented in table . an increase in age decade was associated with a . -point decrease in stress score (se . , p<. ) and a . -point increase in well-being score (se . , p<. ). on average, individuals who did not have insurance reported a . -point higher stress score (se . , p=. ) and a . -point lower well-being score (se . , p<. ). no longer working due to covid- was associated with a . -point increase in stress score and . -point decrease in well-being score compared to individuals who were working remotely before and after covid ("no change" group; se . , p=. ; se . , p=. ). males also reported significantly lower stress scores compared to females (b= . , se . , p<. ). financial concerns and food access concerns were significantly and positively related to depression, anxiety, and stress (all p<. ) and significantly negatively related to well-being (both p<. ). economy-, illness-, and death-related concerns were significantly and positively related to overall stress score after controlling for all demographic variables (all p<. ). additional analyses were considered, including investigating the effects of race/ethnicity and parenthood status. the cell sizes for these variables were too small to conduct analyses. table . logistic regression models showing associations between depression (models and ), anxiety (models and ), demographic variables, and sources of concern (n= ). the imposed social distancing experienced by many throughout the united states undoubtedly contributed to numerous shortand long-term negative effects within the population. this survey aimed to identify the impact of the covid- pandemic and imposed social distancing on mental health among us residents within a small window of time during which many businesses were closed and many individuals were out of work. based on the findings associated with this convenience sample, when compared to prepandemic representative population-level data in the united states, it appears that mental health declined overall during the late spring of . prevalence rates of both depressive symptoms and anxiety symptoms were notably higher than national prepandemic averages. in addition, mental well-being significantly decreased, and stress levels were elevated in this sample. these findings support early evidence that the effects of the pandemic on mental health are significant [ ] . the findings from the regression analyses suggest that age may be an important factor in considering mental health impacts of the pandemic. as age increased, anxiety symptoms, depression symptoms, and stress decreased, and well-being increased. this effect may be explained by stress on younger individuals due to inconsistent income or parenting-related obligations; however, these relationships could not be analyzed due to small cell sizes. based on a review of the limited literature specifically related to the covid- pandemic, rajkumar [ ] found that older adults were at greater risk for mental health concerns [ ] . no other studies we reviewed found a relationship with age. further research should be conducted to determine mental health risks relative to age and associated factors during the covid- pandemic. findings from this study suggest loss of work due to pandemic-related closures greatly increased the odds of depression symptoms when compared to individuals who did not experience a change in their employment (were working remotely both before and after closures began). loss of employment was also related to increased stress levels and decreased mental well-being. this could indicate a segment of the population that may require additional support to overcome mental health challenges during the pandemic. economic crises have been tied to poor mental health outcomes in numerous studies [ , ] . employment, in contrast to unemployment, has been linked to decreased mental illness, including depression and anxiety, and increased mental well-being [ ] . job instability, including moving from a permanent position to a temporary position, has been linked to increased mental illness [ ] . public health officials should make targeted efforts to reach out to the segment of the population that completely lost the ability to work during social distancing regulations. these individuals may need aid that extends beyond financial support. partial and no insurance coverage was associated with increased odds of depression symptoms when compared to fully insured individuals. this finding supports previous evidence that increased health care coverage reduces the prevalence of undiagnosed and untreated depression [ ] . individuals with limited health coverage also had higher stress scores and lower well-being scores. a similar effect was seen with moderate to severe anxiety. this finding was particularly pronounced in the uninsured population. the effects of partial or no insurance coverage on mental health may be exacerbated by the circumstances of the pandemic. those with no insurance demonstrated extremely high odds of anxiety symptoms. this is likely related to concern about what would happen to them if they contracted covid- . practitioners working with uninsured and partially insured individuals should take note of potentially decreased mental health in this population. although these practitioners may not have the ability to affect their patients' insurance status or concerns about the potential financial burden of contracting covid- , they do have the opportunity to encourage low-or no-cost coping methods that may decrease depressive and anxiety symptomatology. several other factors demonstrated relationships with mental health. males reported significantly lower stress levels than females. this is consistent with findings on gender and stress [ ] . this difference in stress levels may be due to gender differences in coping with stressful situations and differences in hormonal responses to stressful events [ ] . increased family financial concern and family food access concern were positively related with depression symptoms, anxiety symptoms, and stress, and negatively related to well-being. in addition, concern about the economy, illness-related concern, and death-related concern were positively related to stress scores. the financial concern and food security findings are consistent with previous work investigating this relationship [ , ] . each of the relationships between the concern items and mental health variables is consistent with expected outcomes from the covid- pandemic [ ] . practitioners may wish to ask their patients about specific concerns that they may be experiencing during this time. using a sliding scale for medical fees and having referrals and information about different types of aid available (eg, food banks and local, state, and federal funds) may reduce the mental burden on some individuals. practitioners are also in the best position to convey accurate information about covid- risk status and effective protective measures. information of this type can be conveyed in person or online through practice websites and social media. this reliable information may counteract the concern of illness and death and reduce poor mental health outcomes. there are noteworthy limitations to this study. the convenience sample was primarily insured, non-hispanic, white, and female, which may have led to results that are not generalizable to the broader population of us adults. minority populations tend to experience the effects of trauma to a greater degree than others. given the results seen in this study in a non-hispanic white population that is primarily insured, it is reasonable to assume that minority populations may be impacted to an even greater degree than what was demonstrated in this study. particular care should be taken to measure and address these concerns in future studies. in addition, due to the small number of african americans in this sample, we were not able to explore the relationship between race and mental health, a limitation that should be prioritized for exploration in follow-up research. in addition, the sample did not include a representative percentage of young people or individuals with children. given the age effects in this study, further investigation is encouraged to determine the effect of age on mental health outcomes during the pandemic. the results of this study are based on a comparison with prepandemic norms, which may not be representative of the morbidity of these mental health conditions in peripandemic or postpandemic times. functional impairment was not measured. therefore, assumptions about the impact of negative mental health symptomatology in the peripandemic period cannot be made. furthermore, the survey was conducted online, which likely inadvertently excluded individuals that do not have access to or are uncomfortable with the internet. the strengths of this study include the large sample, which consisted of respondents from of states in the united states. this survey was also developed and launched early in the pandemic's course through the united states. therefore, it likely captured early mental health responses that later surveys may not have captured. these responses included both mental health struggles and positive mental health indicators. this study was designed with a follow-up in mind. respondents to this survey were asked if they would be willing to participate in a follow-up survey at a later date. this will allow for longitudinal data collection at multiple time points as social distancing restrictions change throughout the united states. our findings suggest that many us citizens, particularly non-hispanic, white, insured individuals, are experiencing high stress, depressive, and anxiety symptomatology. practitioners, including health care workers and mental health specialists, can be a resource for those struggling with mental health concerns during the pandemic. these messages should not only be made in person, but also through practice websites and social media accounts. the overwhelming amount of information available to the public regarding covid- makes it difficult to delineate accurate information from inaccurate information [ ] . practitioners have a preexisting rapport with their patients that they should use to shift the balance toward accurate information. this patient-provider relationship may engender trust that does not exist with larger health or government entities. practitioners should capitalize on this rapport to convey accurate, timely information regarding risk factors, protective measures, coping techniques, financial relief, and food banks. policy makers should encourage growth in areas of mental health support that are most feasible during this time. telemental health, for example, has been shown to be highly effective, cost-efficient, and accessible, especially in isolated communities [ ] . online mental health assessments and self-directed mental health interventions have also been widely introduced in china, with their effectiveness remaining to be seen [ ] . future research should continue to track the mental health effects of the pandemic as it progresses. there may be future waves of illness that impact social distancing recommendations and requirements. these, in turn, may impact mental health. longitudinal investigation of these effects is recommended. future studies should make concerted efforts to obtain a representative sample. representative state-specific samples are available through various entities for a fee. in addition, specific outreach to underrepresented populations is recommended. knowledge of these fluctuations in 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mental well-being scale (wemwbs) in northern ireland mental health services for older adults in china during the covid- outbreak. the lancet psychiatry the mental health benefits of employment: results of a systematic meta-review the impact of precarious employment on mental health: the case of italy the effect of medicaid on management of depression: evidence from the oregon health insurance experiment. milbank q stress#:~:text=women% are% more% likely% than% men% ( % percent% vs. , % ( % percent)% men stress: physiology, biochemistry, and pathology financial concern predicts deteriorations in mental and physical health among university students food insecurity and mental health status: a global analysis of countries mental health and the covid- pandemic distinguishing between factual and opinion statements in the news telemental health care, an effective alternative to conventional mental care: a systematic review online mental health services in china during the covid- outbreak. the lancet psychiatry this study was supported by nih/ncrr colorado ctsi grant number ul rr . its contents are the authors' sole responsibility and do not necessarily represent official national institutes of health (nih) views. research, is properly cited. the complete bibliographic information, a link to the original publication on http://formative.jmir.org, as well as this copyright and license information must be included. key: cord- -ixol k k authors: richards, edward p.; rathbun, katharine c. title: making state public health laws work for sars outbreaks date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: ixol k k nan the case of quarantine due to disease, a judge would determine whether the state has shown that the detained person deserves quarantine. the judge must defer to public health authorities on their choice of public health strategies ( ) . public health orders get the most permissive judicial review, the rational relationship test, because they are based on objective criteria, are usually of limited duration, and are necessary to prevent imminent harm ( ) . with the advent of aids in the s, some civil libertarians argued that the old public health laws were outdated and no longer enforceable. there was no judicial support for this argument then ( ) , and today's courts are even more supportive of state powers to protect the public. nonetheless, many states rewrote their isolation and quarantine laws to provide varying levels of mandatory judicial review, in some cases requiring that a person be provided counsel and an opportunity for a trial before detention. such proceedings take so much time and money that they make it almost impossible to impose quarantine ( ) . even public health laws rewritten in the wake of the / events often include judicial review provisions that would be unworkable in a large outbreak; persons would either be detained illegally or be released because of legal technicalities. improperly detained persons can sue, and these lawsuits will probably not be barred by the immunity provisions in emergency public health laws. improperly released persons will nullify the disease control plan. the best way to balance public protection with private rights is to use administrative hearings rather than judicial hearings to review quarantine and other public health orders. administrative review is used routinely in state and federal agency proceedings, including for mental health commitments in maryland ( ). courts have required more due process for mental health commitments than for quarantines; this difference is strong evidence that administrative review would be an acceptable alternative for public health orders. such reviews can be appealed to the courts, but having the agency do the first review makes a factual record that allows quick and efficient judicial review. a petitioner can be required to go through an agency appeal before a habeas corpus review by the courts ( ) . persons who want to contest their isolation orders could be required to petition the decision maker doing the reviews. this petition could be to a health agency staff member or an appointed board. the health agency would present the basic information, and the petitioner could supply additional information in writing. telephone interviews could be used to allow personal statements without the danger of in-person testimony. the decision maker would make a brief, written ruling based on predefined classifications. this ruling could be reviewed by an agency appeals board and would greatly simplify any subsequent appeal to the courts ( ) . if such a process is adopted, the statutory language to implement these reviews should be kept general to allow flexibility in the face of different epidemic conditions. such a review should also be part of the quality assurance for isolation and quarantine orders. a key part of any isolation and quarantine process for sars would be thorough recordkeeping of all orders, whom such orders apply to, their duration, and the disease outcome in each case. there should be administrative oversight to ensure that the orders are proper and that other necessary actions are carried out, such as providing food and medical services to restricted persons. a major sars outbreak would stretch many state and local public health laws to the breaking point. these laws should be reviewed and rewritten as necessary. fair process can be based on sound administrative law principles that dramatically reduce the role of judicial review in isolation and quarantine orders. dr. richards is professor of law at the louisiana state university law center, where he directs the program in law, science, and public health. professor richards has a background in medical and public health science and has researched and published extensively on health and public health law. his special expertise is the administrative law basis for state and federal public health practice. dr. rathbun practices medicine at the ochsner clinic hhs/cdc legal response to sars outbreak bring out your dead: the great plague of yellow fever in philadelphia in compagnie francaise de navigation a vapeur v. board of health of state of louisiana the commonwealth fund inc. v. natural resources defense council mark's baths, misc the role of the police power in st century public health the jurisprudence of prevention: society's right of selfdefense against dangerous individuals outbreak of multidrugresistant tuberculosis-texas, california, and pennsylvania state ex rel. mcbride v. superior court for king county, wash. , p foundation in baton rouge, louisiana. a fellow in the american academy of family physicians, she publishes and lectures on public health and bioterrorism-related issues. key: cord- -r k ob authors: raina macintyre, c.; engells, thomas edward; scotch, matthew; heslop, david james; gumel, abba b.; poste, george; chen, xin; herche, wesley; steinhöfel, kathleen; lim, samsung; broom, alex title: converging and emerging threats to health security date: - - journal: environ syst decis doi: . /s - - - sha: doc_id: cord_uid: r k ob advances in biological sciences have outpaced regulatory and legal frameworks for biosecurity. simultaneously, there has been a convergence of scientific disciplines such as synthetic biology, data science, advanced computing and many other technologies, which all have applications in health. for example, advances in cybercrime methods have created ransomware attacks on hospitals, which can cripple health systems and threaten human life. new kinds of biological weapons which fall outside of traditional cold war era thinking can be created synthetically using genetic code. these convergent trajectories are dramatically expanding the repertoire of methods which can be used for benefit or harm. we describe a new risk landscape for which there are few precedents, and where regulation and mitigation are a challenge. rapidly evolving patterns of technology convergence and proliferation of dual-use risks expose inadequate societal preparedness. we outline examples in the areas of biological weapons, antimicrobial resistance, laboratory security and cybersecurity in health care. new challenges in health security such as precision harm in medicine can no longer be addressed within the isolated vertical silo of health, but require cross-disciplinary solutions from other fields. nor can they cannot be managed effectively by individual countries. we outline the case for new cross-disciplinary approaches in risk analysis to an altered risk landscape. few precedents or analytical tools. these technologies are increasingly available to hostile states and non-state terrorist groups. the rapidly evolving landscape of dual-use risks illustrates how societal preparedness for new challenges in health security can no longer be addressed within isolated vertical siloes. nor can they cannot be managed effectively by individual countries. well-recognised threats in the areas of biological weapons, surveillance for bioterrorism, laboratory security and antimicrobial resistance are discussed. we also highlight emerging new areas of threat in the intersection of health security and cybersecurity and enabling of precision harm through big data in medicine. against this backdrop, we outline below the need for new governance and risk analysis approaches that are global and cross-disciplinary. it has been possible since to create synthetic viruses in a laboratory, when researchers at the state university of new york at stony brook published the synthesis of the poliovirus in science (cello et al. ). there are now over private companies in synthetic biology (global engage ), which are self-regulated with voluntary codes of conduct (samuel et al. ). whilst prior biosecurity efforts focused on the biological materials themselves and the inherent challenges of securing and accounting for these materials within laboratories, genetic code can now be transmitted rapidly and used to create new or modified infectious pathogens (kelle ). in the specific case of synthetic infectious agents, the unique characteristic of transmissibility from person-to-person raises special concerns about health security. a virus manufactured in one location may spread worldwide and has a major population impact, thus requiring a global risk mitigation approach. the global regulation of synthetic biology pertaining to communicable diseases is challenging, with many models proposed . the tapic (transparency, accountability, participation, integrity and policy capacity) framework provides a guide to good governance (trump ) , but there is no enforceable global governance system in place as yet. the many private synthetic biology companies worldwide remain self-regulated, with voluntary guidelines about reporting of suspicious orders. a case in point is smallpox, for which the genome is fully sequenced and publicly available. in a report, the who (world health organization d) concluded that destroying existing stocks of smallpox in the usa and russia would serve no purpose because the virus can be created using synthetic biology. whilst it is theoretically possible for smallpox to be synthesised in a laboratory, experts have believed this to be a complex task. however, in , canadian scientists synthetically created an extinct poxvirus, closely related to smallpox, for $ , in a laboratory using mail-ordered genetic sequences (koblentz ) , illustrating the very real risk of synthetic smallpox emerging as the cause of a pandemic. in addition to synthetic biology, viruses and bacteria can be engineered for enhanced pathogenicity. a revolutionary new precision tool for gene editing, clustered regularly interspaced short palindromic repeats (crispr cas ) associated nuclease cas , raises concerns about dual-use potential (ran et al. ) . whilst crispr cas offers the prospect of cures to major diseases, it also enables the precision design and construction of engineered microorganisms as potential weapons of mass destruction. in , the us director of national intelligence rated crispr cas as a leading weapon of mass destruction threat (mit technology review ). yet global planning for bioterrorism preparedness is still largely framed by cold war concepts and is largely limited to scenarios involving agents such as smallpox and anthrax in a twentieth-century context. however, contemporary biology presents an expanded threat spectrum with an unlimited array of possible engineered agents that transcend the scope of traditional concepts of biosecurity surveillance, preparedness and counter-measures. the convergence of security threats is illustrated by the use enabling technologies such as the dark web for trade in biological weapons and planning of bioterrorist attacks (macintyre ). a natural epidemic is one which arises in nature, without intervention by humans. unnatural epidemics are those which are caused by human intervention and may be deliberate or accidental release of either naturally occurring or altered pathogens. bioterrorism is the deliberate release of such pathogens to cause harm (venkatesh and memish ) . bioterrorism differs from other forms of terrorism in that a bioweapon is microscopic and invisible, and release of a bioweapon is not always recognisable as a deliberate attack (macintyre and engells ). all category a bioterrorism agents except smallpox also occur in nature. for example, anthrax occurs more frequently in nature (such as through humans handling infected animal carcasses) than as a bioterrorism attack (fong and alibek ) . planning for bioterrorism is underpinned by the assumption that attacks will be recognised as unnatural, but no public health systems exist to differentiate the aetiology of epidemics. tools such as the grunow and finke ( ) criteria are not well known in public health and have low sensitivity for detecting unnatural epidemics when tested against historical events (chen et al. ; macintyre and engells ) . public health agencies do not routinely use such tools and default to the assumption that they all epidemics are natural (macintyre ). there has been an unprecedented increase in the frequency of serious global epidemic risks such as ebola, avian influenza, mers coronavirus and zika virus in recent years (sands et al. ). this cannot be explained solely by environmental and ecological factors, which have changed at a slower rate than the increase in emerging infections. in a recent analysis , we documented that the rate of emergence of new strains of influenza virus infecting humans is escalating at an unprecedented rate, thereby increasing the probability of a pandemic. changes in climate, urbanisation and agricultural practices as well as improved global surveillance may have some role in this phenomenon, but have not changed at the same rapid rate as virus evolution. whether some of these new outbreaks involve engineered agents is unknown and has not been publicly analysed. historically, unnatural epidemics have not always been recognised at the time. for example, the rajneesh salmonella attack in oregon in was not only undetected as a bioterrorist attack, but when a local politician suggested bioterrorism, he was ridiculed by public health officials (mac-intyre ; török et al. ) . operation seaspray, which caused a serratia marcescens outbreak in san francisco in , was not recognised at the time as an open-air test by the us military, which was later disclosed in (wheat et al. ) . the accidental anthrax release in sverdlovsk, soviet union, , was investigated by us experts, who initially incorrectly believed the soviet explanation that it was a natural outbreak (the atlantic ). there are many other examples of failure to correctly identify unnatural epidemics (tucker and zilinskas ) . at a time when genetic engineering and synthetic biology contribute to increased risk of biological attacks, there is a need for new tools and risk analysis methods to rapidly identify unnatural epidemics. yet the grunow-finke criteria despite low sensitivity (macintyre and engells ) remain the best available tool. other tools have been developed but are even less known and used than the grunow-finke criteria (chen et al. ). in addition to risk analysis tools, rapid surveillance methods are required to detect unnatural epidemic signals. new methods for data mining of opensource unstructured data such as social media show promise for rapid epidemic intelligence (the conversation ) but have not yet been utilised for biosecurity (yan et al. ). laboratory safety has been highlighted as a key area of concern, with multiple breaches involving security sensitive pathogens in leading laboratories occurring in recent years (science ). research staff have the unique privilege of working with biological select agents and toxins and possibly the broader group of valuable biological materials (world health organization ), yet insider threat and laboratory accidents are known risks. a related issue is practical impacts of the emerging field of biorisk management in which the previously separate disciplines of biosafety and biosecurity are merged into a singular approach of laboratory biorisk management (cook-deegan et al. ; salerno and gaudioso ) so as to achieve the mutual goal of keeping these materials safe and secure within those areas designated for use and storage. several entities are proposing this combined approach to enhance the risk management process and produce safer laboratories and more secure practices for these materials (association of public health laboratories ). a far too common situation at advanced biomedical research laboratories is a problematic relationship between the researchers and security staff. those relationships must change to reflect a new reality-one in which the research scientist and the law enforcement official are considered members of the same team striving for a mutual goal. those working in laboratories should monitor each other to create a rigorous form of professional self-governance (garrett ) . the implementation of that change will be strategic, for it changes the focus from the substances (biological materials), which because these are alive can be freely found outside the laboratory and continue to defy accurate longterm measurement, to a focus on the behaviours of those who work with these substances-biomedical research scientists, public health officials, clinical laboratorians and others (aquino ) . another threat is a new facet to the insider threat-the potential for radicalisation of health care workers and researchers, for violent extremists continue to defy precise categorisation or predictable profiles and to infiltrate research institutions (macintyre and engells ). in the current age, we must move past our previous solutions dominated by guns, gates and guards and move to a new age in which enhanced personnel security practices through innovative uses of psychology and organisational dynamics will enhance individual and small group accountability and produce a safer laboratory and community at large. doit-yourself biology and biohacker labs fall outside of such systems of governance and are presently self-regulated, but the technology is easily accessible for terrorist groups to establish clandestine labs. no systems exist to detect such laboratories. the risk of emerging infections is increasing, whilst our ability to treat infections with antibiotics is decreasing. antibiotics represent one of the major public health achievements of the twentieth century, which together with vaccines are responsible for the dramatic reduction in morbidity and mortality caused by infections. whilst antimicrobial resistance is not new, its cascading global impact and threat to national and global security are considerable. within a decade, antimicrobial resistance, driven by prolific misuse in animals, humans and food production, and limited development of new antimicrobial options, will present a significant threat to humanity in the twenty-first century. a key solution is to judiciously use our remaining antibiotic options, yet even in relatively well-off organisation for economic cooperation and development (oecd) nations, antibiotic misuse continues virtually unabated in both the human and veterinary sectors (world health organization b). the world health organization ( b) and other key stakeholders have indicated the critical need for immediate global antimicrobial optimisation, reduction in unnecessary usage, and the roll-out of stewardship across health and agriculture sectors. for example, there has been a % global increase in use of last resort antimicrobials (carbapenems) over the last years, and both low-income countries and high-income countries are using substantially more antibiotics per capita than in previous decades (review on antimicrobial resistance ). as with other infectious diseases threats, a global response to this threat is urgently required, with human movement across national borders, threatening antimicrobial viability, even in countries with active surveillance and control programmes. the vertical management of antibiotic use in the human and animal sectors as well as in agriculture and food production must also be addressed in an integrated way, as the volume of use is much higher in these other sectors. a key strategy, in terms of policy, will be the adoption of the one health model for amr supported by who ( a), the eu, and the usa (centers for disease control and prevention ). whilst policy and regulation have progressed considerably in health care environments, a parallel set of strategies will need to be implemented in farming, agriculture and veterinary medicine, which account for around % of antibiotic use (food and drug administration ). thus far, strategies utilised across contexts have largely failed to set national targets to reduce antibiotic use in animal agriculture and nor mandate the collection of antibiotic usage data (martin et al. ) . consumer-led strategies-for example, the marketing of antibiotic free products-are one such strategy that may be used to promote sustainable use of antibiotics in the non-health sector (doyle et al. ) . increasing public awareness of the connections between animal and human health-a cornerstone of the one health approach-will be central to this strategy. there is growing recognition of the costs and significance of amr. multi-resistant organisms are emerging at much higher rates than seen previously, with urgent attention needed to mitigate a risk which is predicted in one report to be the greatest global burden of disease (review on antimicrobial resistance ). one recent estimate indicates that by , infections from resistant bacteria may overtake cancer as the leading cause of death in the world and cost us$ trillion. this estimate has been questioned and likely an overestimate, but amr nonetheless causes a significant burden of disease (de kraker et al. ). the world is in urgent need of new strategies in the human, animal, agricultural and food industries. this includes reviewing how we price/value antimicrobials, incentives for new antimicrobial development and judicious use, and restrictions around use across sectors. in addition, serious amr could be engineered and released as an act of bioterrorism, given the availability of technology such as crisp cas (macintyre and bui ). a longer-term model of population risk (versus immediate individual risk of often minor infection) is required to guide everyday use and mitigate this global threat. whether a bioterrorist attack, pandemic or infections complicated by amr, the risk is increasing as outlined above. infectious diseases do not respect international borders and can spread rapidly around the world. the continued growth in large urban areas, and megacities in particular, in which high population densities represent optimum conditions for spread of infection merits significant attention in biosecurity. this risk is heightened for megacities in developing countries in which serious gaps exist in public health surveillance for early detection of epidemic threats, together with inadequate critical infrastructure and other preparedness resources. prevention, mitigation and control of these threats, therefore, require efforts at local, national and global levels. despite the call for a one health approach (rabinowitz et al. ) , there is no suitable system for governing use of antimicrobials across human health, animal health and food production, and often no coordination of efforts across these sectors. in considering new technologies such as crispr cas (bulletin of the atomic scientists ). the cartagena protocol was developed to address regulation of movements of living modified organisms (lmos) resulting from biotechnology from one country to another, but has focused on ecology and biodiversity and has not been utilised for human biosecurity. the tapic framework (trump ) is a good starting point for considering how existing regulations can be improved and enforced and how new ones could be developed globally. the key needs in risk analysis for biosecurity are timely surveillance and identification of biosecurity threats, risk analysis of impacts and differentiation of natural versus unnatural outbreaks. traditional disease surveillance lacks the timeliness required for rapid detection of emerging and re-emerging pathogens. current public health systems rely on validated data from sources health systems, such as hospital and laboratory data, which are important for analysing trends over time, but do not meet rapid epidemic intelligence needs for early detection of epidemics (yan et al. ). epidemics, defined by a reproductive number greater than one (macintyre and bui ), grow exponentially, so every day of delay in detection could substantially increase the morbidity and mortality burden. mathematical models, typically of the form of deterministic systems of nonlinear differential equations, are often used to gain insight into the transmission dynamics and impact of natural and unnatural emerging and re-emerging infectious diseases that threaten health security, such as disease pandemics (nuno et al. ; nuño et al. ; sharomi et al. ) and the deliberate release of agents of bioterrorism, such as anthrax (brookmeyer and blades ; mushayabasa ; pantha et al. ) and smallpox (banks and castillo-chavez ; del valle et al. ; kaplan et al. ; meltzer et al. ). these models, combined with robust health data analytics, computational and data visualisation techniques and numerical simulations provide a realistic, rapid real-time assessment of threats to public health security. furthermore, informing these models with data generated from modern diagnostic tools that are capable of detecting asymptomatic cases with high degree of sensitivity and specificity (such as peptide-based immune-signaturing or low-cost paper-based rna sequencing) (legutki et al. ; navalkar et al. ; pardee et al. ; stafford et al. ) , and using knowledge of prior bioterrorism attacks and natural disease outbreaks allow for a realistic proactive prediction of future threats before they are detected by the public health system. these approaches allow for a more proactive disease surveillance for human diseases as well as veterinary surveillance for zoonotic pathogens that can mutate and cause major burden in human populations. other modelling paradigms, such as agents-based and other datadriven statistical and stochastic modelling approaches (halloran et al. ; hu et al. ; kaplan et al. ; nuño et al. ) , are also being used for this purpose. a stochastic approach to risk analysis allows model inputs to exhibit a degree of uncertainty. in contrast to deterministic models, the inputs follow various forms of probability distributions. risk is computed by sampling these input distributions many times. therefore, the outcome of a stochastic risk model is a distribution of risk-rather than a single value. the key advantage is that in addition to analysing outcomes, it allows for an analysis of the probability of these outcomes. it also allows for easy scenario analysis and sensitivity analysis. these can all assist decision-makers in taking intervention measures and allocating resources. one such example is a stochastic risk model (hill et al. ) of zoonotic and pandemic influenzas, with a focus on human infection with avian influenza. however, there are few real-time models with applicability in operational public health, with most modelling occurring in academia without real-time applicability for disease control . end-users in the public health system do not have much knowledge or nor trust in modelling, and do not use it widely for disease control (muscatello et al. ) . availability of simple, transparent tools that can assist with pressing questions such as surge capacity planning during the influenza season is what stakeholders value (muscatello et al. ) . although mathematical modelling has enjoyed widespread popularity within the academic public health community in terms of using it to predict epidemics as well as to assess and propose effective containment strategies (newall et al. ) , the use of genetic data (despite its huge potential to provide much deeper insight) for predictive purposes has not yet become a mainstream tool in public health practice (dudas et al. ) . virus phylogeography and phylodynamics are methods developed to utilize viral dna sequences to explore the evolution of pathogens by estimating their ancestry. these methods also show promise for public health surveillance, but are not as well developed or used in public health practice. it has only been somewhat recent that more focus has been on combining descriptive phylogenetic approaches with other modelling methods that attempt to predict epidemics. phylogenetic and phylogeographic analyses can be combined with methods for epidemic modelling to analyse risk factors and predictors of risk in a geospatial and genetic context. geographic information systems (gis) provide a further platform for public health researchers to take a map of an area and add layers of information regarding demographics, disease prevalence and socio-economic status (mondini and chiaravalloti-neto ; rushton ) . when overlaying multiple types of information, relationships and correlations can be discovered, adding analytical value beyond traditional descriptive approaches (doku and lim ) . patient data distributions and timestamps are significant factors in determining the specifics of an epidemic disease. hence, gis techniques such as emerging hot spot analysis and grouping analysis (van steenwinkel et al. ) allow for risk analysis of healthrelated concerns as correlated to location. for example, emerging hot spot analysis (wang et al. ) can help monitor changes and trends of an epidemic disease, such as identifying locations representing new or intensifying hot spots. new risk analysis methods are required to flag epidemics for urgent intervention, as illustrated by the catastrophic consequences of inaction with the ebola epidemic in west africa (world health organization ). we have shown that a simple risk prediction tool can be developed which identifies regions at high risk of severe outcomes of epidemics (argisiri et al. ) . such a tool, which considers disease specific, geographic, political, social, situational and contextual factors, could be used to prioritise epidemic response in situations of limited resources and reduce the impact of serious events. finally, the vast quantities of publicly available, unstructured data such as news feeds, social media and other public information offer potential for rapid epidemic intelligence and early detection, but are not yet accepted in public health (yan et al. ) . google, twitter and other sources have shown early promise for rapid disease detection by using algorithms and natural language processing to detect signals for epidemics, but are still eschewed by traditional public health systems (schmidt ) . rapid epidemic intelligence tools based on social media and news feeds could supplement traditional health system based, validated surveillance systems by providing more timely signals for epidemics of concern (yan et al. ) . we have shown that the ebola epidemic of could have been detected months earlier than it was using a novel twitter-based tool (yan et al. ). in addition, risk analysis frameworks play an important role in biosecurity decision-making and policy. using the approach of multiple criteria based upon emerging biotechnologies such as synthetic biology, traditional risk assessment such as health and environmental data, and other characteristics such as the uncertainty, reversibility, manageability of risk and levels of public concern (cummings and kuzma ; trump et al. ) , can be integrated to provide evidence-based information to government, academia and non-governmental organisations. such risk analysis methods could assist decision-makers to rank policy priorities and to improve the governance of biosecurity. whilst new risk analysis methods and tools are continually developed, many of the established methods for risk analysis of emerging infections are used separately and in different contexts. with increasing biothreats in society, these methods could be better integrated to add value improve the capacity to predict and mitigate risk. biosecurity is affected by cybersecurity concerns, but planning for biosecurity often fails to consider critical dependencies with information technology and computing. for example, mitigation and prevention of bioterrorism require surveillance for trade in bioweapons. the dark web offers terrorists a platform for trade in weapons, including bioweapons. numerous dark web marketplaces such as silk road and alphabay have been shut down by us law enforcement in recent years, but new ones continue to emerge (business insider australia ). whilst such market places are better known for trading in drugs and weapons, in a new york university student was arrested for attempting to purchase a category b bioterrorism agent, ricin, on the dark web (new york post ) . this highlights the need for integration of cybertechnology as a tool in prevention and surveillance for bioterrorism. surveillance for planned bioterrorism is not as well advanced in this realm as it is for traditional forms of terrorism. law enforcement agencies employ surveillance of the dark web and social media to detect chatter about planned terrorism, but the focus has been far less on bioterrorism. for example, surveillance for purchase of genetic code to create dangerous viruses failed to pick up the canadian scientists who created an extinct poxvirus in the laboratory using mail-order dna (science ). the world first knew about this experiment only when the scientists announced it. whilst this group was legitimate and not engaged in bioterrorism, the same methods for procurement which they used could well be used by terrorist groups. therefore, surveillance is required to detect such activity and prevent bioterror attacks. it was reported in that the unique health records of all australians are available for sale on the dark web, a fact uncovered by a reporter, not by law enforcement or government, exposing authorities as completely unprepared (bickers et al. ) . cyberattacks and cybertheft affect all facets of society, from banking and health to critical infrastructure (the age ). in many cases, the outcome of a cyberattack is loss of money or assets. however, if critical infrastructure or health systems are attacked, human lives may be lost. for example, if the power grid of a city is compromised, this has many flow-on effects on health systems, such as loss of functioning of critical equipment in intensive care units or operating theatres, or even for home interventions that rely on power such as nebulisers or oxygen (lee et al. ) . hospitals rely on generators as backup, but these can fail in the event of a disaster (parson ; sifferlin ) . the escalation of ransomware attacks on hospitals, which are poorly prepared and easy targets, can bring whole health systems to standstill, as seen within the uk nhs and us hospitals (deane-mckenna ; gillett ; landi ) . the goal of most health systems is to achieve paperless operations, to which the electronic patient medical record is central. yet the zeal for electronic health (e-health) has progressed with very little consideration of cybersecurity, leaving hospitals vulnerable to ransomware attacks (cbsnews ). the aspiration of health systems towards the e-health record is driven by the desire to improve care, protect patient safety and reduce medical errors (australian digital health agency ). the e-health record (ehr) has also been embraced by researchers as a means to efficient health research through data linkage of large administrative databases (powell and buchan ) . for example, data linkage was used to show that ct scans are associated with childhood cancer (mathews et al. ) . whilst big data allows new ways of conducting medical research, the risk of hacking of the ehr has not been adequately mitigated in health care. education and training in hospital and health management does not routinely offer courses in cybersecurity, leaving health planners and hospital managers unaware of the risk and underprepared. participants in the us federal medicare ehr incentive program have to attest that they have a fundamental cyber security programme and have adopted certified ehr technology (the office of the national coordinator for health information technology ). hospitals attesting meaningful use are legally bound to meet specific standards, including protection of the her, and can be audited. however, even this system has not protected us hospitals from cyberattacks (cbsnews ), and many countries do not have any such safeguards. precision medicine has revolutionized medicine, with the ability to tailor treatments for individuals by combining detailed medical, genetic and other patient information. this, however, also leads to the possibility of the same information being used to tailor "precision harm". it is well recognised that individuals can be targeted by biological weapons (macintyre and engells ), but convergence of technology opens new avenues for precision harm of individuals. the catastrophic hacking of the us office of personnel management (opm) in (mukherjee ) exposed data on over million us federal employees. at the same time, anthem health, the largest provider of health insurance to these employees, was also hacked (tuttle ) . data linkage would allow the perpetrators to access the sensitive personal medical information of employees, identify their medical vulnerabilities and plan targeted attacks, such as medication tampering or hacking of digital medical devices. the risks posed by hacking digital medical devices such as pacemakers and insulin pumps are also cause for concern (francies ) . this includes more extreme scenarios in which individuals with high political profiles or other strategic value could be assassinated by manipulation of their medical devices, tampering with their medication regimen or the design of microbial agents matched to their individual genetic profile. former us vice president dick cheney had his pacemaker wireless function disabled to mitigate such risk (peterson ) . if hostile states, organised crime groups or terrorist gain digital medical information on defence or security professionals, government officials or judges, it may become a more attractive option to more obvious methods for causing harm. figure illustrates the potential for precision harm targeting high profile individuals, enabled by convergence of technologies. in the example provided, a federal judge could be targeted in several different ways, including biological weapons, hacking of digital medical devices, medication tampering, interference with scheduled medical procedures or use of toxins or immune modulators, once a roadmap for precision harm is created. this example could apply to linkage of data from the opm and anthem health hacks to create personalised medical profile for federal employees. these examples illustrate the convergence of cybersecurity and health security and the need for more integrated approaches to prevention and mitigation of emerging risks in health care. in summary, we face rapid advances in science and technology, a corresponding escalation of risk to biosecurity, and convergence of multiple security threats which have traditionally been addressed separately. the changing landscape in biothreats and convergence with other areas of security can no longer be addressed in the traditional narrow, healthcentric way. the solution requires a multidisciplinary, global approach to security, whilst meeting local government regulatory requirements. we need new methods to prevent, identify and mitigate threats to biosecurity, which require cooperative thinking across national and professional boundaries. globally, health, law enforcement, defence and intelligence agencies will need to collaborate and pool their information and expertise. new risk analysis methods and surveillance tools need to be developed, and old methods may need to be used in new ways. this must be addressed in a coordinated global way to ensure risk is minimised. radicalized health care workers and the risk of ebola as a bioterror weapon a risk analysis approach to prioritising epidemics-ebola virus disease in west africa as a case study biorisk management for clinical and public health laboratories benefits of having a my health record hackers are offering to sell the medicare 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novel avian influenzas early detection of bioterrorism: monitoring disease using an agent-based model analyzing bioterror response logistics: the case of smallpox synthetic biology and biosecurity. from low levels of awareness to a comprehensive strategy the de novo synthesis of horsepox virus: implications for biosecurity and recommendations for preventing the reemergence of smallpox hhs notice: wannacry malware continues to impact u.s. healthcare orgs analysis of the cyber attack on the ukrainian power grid scalable high-density peptide arrays for comprehensive health monitoring biopreparedness in the age of genetically engineered pathogens and open access science: an urgent need for a paradigm shift pandemics, public health emergencies and antimicrobial resistance-putting the threat in an epidemiologic and risk analysis context current biological threats to frontline law enforcement: from the insider threat to diy bio law enforcement executive antibiotics overuse in animal agriculture: a call to action for health care providers cancer risk in , people exposed to computed tomography scans in childhood or adolescence: data linkage study of million modeling potential responses to smallpox as a bioterrorist weapon top u.s. intelligence official calls gene editing a wmd threat spatial correlation of incidence of dengue with socioeconomic, demographic and environmental variables in a brazilian city anthem's historic health records breach was likely ordered by a foreign government translation of real-time infectious disease modeling into routine public health practice dynamics of an anthrax model with distributed delay acta applicandae mathematicae: an international survey application of immunosignatures for diagnosis of valley fever ex-nyu student gets years in jail for trying to buy ricin cost-effectiveness analyses of human papillomavirus vaccination assessing the role of basic control measures, antivirals and vaccine in curtailing pandemic influenza: scenarios for the us, uk and the netherlands protecting residential care facilities from pandemic influenza optimal control applied in an anthrax epizootic model rapid, low-cost detection of zika virus using programmable biomolecular components -year flood paralyzes texas medical center yes, terrorists could have hacked dick cheney's heart the plus alliance mobilises to solve problems of global security electronic health records should support clinical research toward proof of concept of a one health approach to disease prediction and control genome engineering using the crispr-cas system review on antimicrobial resistance ( ) tackling drug-resistant infections globally: final report and recommendations. review on antimicrobial resistance public health, gis, and spatial analytic tools laboratory biorisk management: biosafety and biosecurity the neglected dimension of global security-a framework for countering infectious-disease crises trending now: using social media to predict and track disease outbreaks lab incidents lead to safety crackdown at cdc how canadian researchers reconstituted an extinct poxvirus for $ , using mail-order dna modelling the transmission dynamics and control of the novel swine influenza (h n ) pandemic lessons from storm sandy: when hospital generators fail immunosignature system for diagnosis of cancer victoria police cancel hundreds of speeding fines after wannacry virus attack how dna evidence confirmed a soviet coverup of an anthrax accident social media for tracking disease outbreaks-fad or way of the future? https://theconversation.com/ social-media-for-tracking-disease-outbreaks-fad-or-way-of-thefuture- the office of the national coordinator for health information technology ( ) guide to privacy and security of electronic health information a large community outbreak of salmonellosis caused by intentional contamination of restaurant salad bars synthetic biology regulation and governance: lessons from tapic for the united states a decision analytic model to guide early-stage government regulatory action: applications for synthetic biology the smallpox epidemic in aralsk, kazakhstan, and the soviet biological warfare program cyberdisaster: how the government compromised our security assessing biosecurity practices, movements and densities of poultry sites across belgium, resulting in different farm riskgroups for infectious disease introduction and spread bioterrorism-a new challenge for public health measuring the deconcentration of housing choice voucher program recipients in eight us metropolitan areas using hot spot analysis infection due to chromobacteria; report of cases who, geneva world health organization ( ) report of the ebola interim assessment panel antimicrobial resistance world health organization ( b) global action plan on antimicrobial resistance world health organization ( c) international health regulations (ihr) world health organization ( d) who advisory committee on variola virus research: report of the eighteenth meeting utility and potential of rapid epidemic intelligence from internet-based sources the authors are affiliated with global security key: cord- -f j fsc authors: chamboredon, p.; roman, c.; colson, s. title: covid‐ pandemic in france: health emergency experiences from the field date: - - journal: int nurs rev doi: . /inr. sha: doc_id: cord_uid: f j fsc aim: this paper describes the situation regarding covid‐ emergency in france as of early may , the main policies to fight this virus, and the roles and responsibilities of nurses regarding their work at this time, as well as the challenges facing the profession. background: europe continues to be affected by the covid‐ pandemic. at the time of writing france was the fourth country with the highest number of detected cases and cumulative deaths. sources of evidence: websites of the world health organization, french government, french agency of public health, french national council of nurses and clinicaltrials.gov database, as well as the experiences of the authors. discussion: the history of the development of the pandemic in france helps explain the establishment of the state of health emergency and containment of the population. many decisions made had undesirable repercussions, particularly in terms of intra‐family violence, mental health disorders and the renunciation of care. hospitals and primary care services, with significant investment by nurses, played a key role in the care of persons with and without covid‐ . conclusion: france has suffered a very high toll in terms of covid‐ morbidity and mortality, and effects on its people, health systems and health professionals, including nurses. implications for nursing practice: nurses are recognized for their social usefulness in france. however, it is important to consider the collateral effects of this crisis on nurses and nursing and to integrate the health emergency nursing skills established during the pandemic into the standard field of nursing competence. implications for nursing policy: the nursing profession has expectations of a reflection on and revision of nursing skills as well as of its valorization in the french healthcare system, notably carried out by the french national council order of nurses. • present a brief history of the development of the pandemic in the country, including the political decisions that have been taken to combat it; • explain the repercussions of containment measures on the health of the population; • describe the roles and responsibilities of nurses regarding their work during the pandemic, as well as the challenges facing the profession; and • summarize the current french research studies in progress about covid- . the covid- pandemic is undoubtedly the most serious global health crisis in decades, causing more than deaths worldwide as of may (world health organization [who] a). this is a devastating new virus. first reported in wuhan, china, on december , the virus gradually spread to europe and the rest of the world (who b). the emergency situation was declared by who on january . within days of the outbreak of the virus, the director-general of who found that more than . million people were confirmed as infected, of whom nearly died (who c) . at the time of writing on may , the situation in europe remains catastrophic: more than reported cases and more than cumulative deaths (who d) . the most affected countries are spain ( detected cases, cumulative deaths), the united kingdom ( detected cases, cumulative deaths), italy ( detected cases, cumulative deaths), germany ( detected cases, cumulative deaths) and france ( detected cases, cumulative deaths). the situation has necessitated the reorganization of healthcare systems and changes in population lifestyles and has led to particularly difficult economic consequences. to date, the primary strategy has been to utilize cross-contamination measures to prevent the spread of the virus such as good hand hygiene, avoiding close contact with others or social distancing and respecting respiratory hygiene rules. population containment measures have been implemented in many countries, and particularly in france, from march . france is the fourth most affected country in europe. the number of deaths is important, but just as important are the more than people who underwent hospitalization for covid- (french public health ) . the data are updated daily. the most reliable indicator to date remains the incidence of covid- cases entering resuscitation/critical care every day, which is beginning to plateau. france must manage the first wave of the pandemic while deploying all means to avoid a second wave. health policies must then adapt to a virus whose spread is not fully known and whose treatments are currently being evaluated. these many unknowns in the equation lead to the need to adjust policy measures in france on an almost daily basis. in preparing this report from the field, relevant information was taken from the websites of who, french government, french agency of public health and french national council of nurses. the clinicaltrials.gov database was also examined. we have also drawn on our experiences as french nurses. the identification of the first three cases of covid- positive patients was announced by the ministry of solidarity & health ( a) on january . the virus began to circulate in france, considered to have been transmitted by people who had stayed in china or singapore and had been in contact with infected people. the first death in france was announced on february (ministry of solidarity & health b). despite the isolation of the cases identified and the reminder to the public to practice barrier actions, covid- spread. subsequently, the minister of solidarity and health, olivier v eran, initiated the plan d'organisation de la r eponse du syst eme de sant e en situations sanitaires exceptionnelles (orsan) (organizational plan for health system response in exceptional health situations) under the epidemic and biological risk section on february , enacting the various protocols to be implemented in the context of a health crisis (ministry of social affairs, health and women's rights ). stage of this plan consisted of isolating the identified cases and the people they had been in contact with, at the time numbering about people, to slow down the spread of the virus in the country. a few days later, on february , france moved to stage , which consisted of slowing down the viral spread, following the identification of several epidemic outbreaks and the first deaths linked to covid- . barrier measures were widely disseminated to the population, and containment measures were implemented locally in areas with identified infectious outbreaks. on march , when who declared the status of a pandemic concerning the novel coronavirus (who e), crisis measures were taken by the president of the french republic ( a) and his government, to control the epidemic and manage the health situation, namely, the closure of the nurseries, schools and universities for users as of march ; the introduction of short-time work hours for employees whose companies cannot carry out their activities and of teleworking for all employees who have this possibility of adjusting the exercise of their profession (ministry of solidarity & health c). however, a few days later, the number of cases and deaths increased. stage was declared to reduce the circulation of the virus in the population and mitigate its effects. all nonessential public places were closed, and several measures put in place by the french government to manage what was becoming the country's biggest health crisis in several decades. on march , the president of the french republic spoke live on television, declaring that 'we are at war' against covid- ( b) . the white plan corresponded to the provisions of orsan to organize health facilities in response to a major health crisis (ministry of social affairs, health and women's rights ). it consisted of four points: mobilizing health establishments to respond to a crisis situation, mobilizing health professionals, mobilizing the material and logistical resources of establishments and adapting their medical activity. initiated in health establishments close to identified epidemic outbreaks, the white plan was generalized throughout france when the epidemic reached stage . a new gradation of care began to be implemented: university and public hospitals as the first line to receive patients with covid- , private hospitals with at least an emergency department and critical care service as the second line and private hospitals with critical care service as the third line. all other care facilities were placed in the fourth line. covid- units were set up in more than public hospitals, and new resuscitation places were being created, increasing the capacity from to beds (prime minister of the french government ). healthcare professionals were mobilized as well as health students on internships or volunteers, and retired people were also called upon to strengthen healthcare teams. the french system of mobilization by the state of volunteer health professionals in exceptional health circumstances, known as the health reserve, was activated to provide support in the areas most affected by the epidemic (ministry of solidarity & health d). non-urgent medical activities were deprogrammed, and the monitoring of chronic pathologies was reorganized. primary care teams, especially home care nurses, were also referred to as backup, to manage not only the usual care of the population but also the aftercare of covid- patients discharged from hospital or those who did not require hospitalization, only simple monitoring at home. however, as the existing legislative and regulatory measures were not sufficient to deal with the crisis, the french state introduced the state of health emergency (president of the french republic c). this new state of health emergency covered parts or all of the territory (including overseas territories) in the event of a health disaster that, by its nature and severity, endangered the health of the population. within this framework, the prime minister, as head of the french government, could decree measures listed by the law: order home confinement, requisition personnel and equipment, and prohibit gatherings. the prime minister could also take temporary measures to control the prices of certain products, allow patients to have access to medicines and decide on any regulatory limits to entrepreneurial freedom. the minister responsible for health could, by ministerial order, determine other general and individual measures. the military operation 'resilience' was launched on march (ministry of the army ). the french army served as a reinforcement to provide assistance and support to the population and public services in terms of health, logistics and protection of the entire territory. mistral and dixmude helicopter carriers were deployed in the southern indian ocean (reunion, mayotte) and in the antilles-guyana regions. implementation of containment throughout france up to may to decelerate the circulation of the virus, the government implemented a containment of the french population (prime minister of the french government b). travel was severely restricted. a certificate justifying individual movements was required to leave the home, and checks were carried out by the police and the army to ensure that these restrictions were respected by the population. those not respecting the confinement were fined or even sentenced to imprisonment according to the severity of the situation. economic measures were put in place urgently by the french state (president of the french republic c). to safeguard jobs and reduce the risks of job insecurity, a shorttime working scheme was launched for the duration of the confinement, enabling more than million people to receive at least three-quarters of their wages. an adapted sick leave scheme was set up for parents of children under years old who could not telework, pregnant women in the third trimester, and vulnerable or fragile persons. unemployment benefit entitlements were extended for persons reaching the end of their entitlement. several types of aid were likewise offered to companies affected by the crisis, to safeguard them and secure jobs in france. concerning children's schooling, pedagogical continuity was achieved at a distance, in virtual classes, or through homework assignments to be carried out with the help of parents. this system had major limitations, including the absence of computer equipment in low-income families, saturation of the bandwidth of internet connections and saturation of educational platforms, which are not accustomed to such a large number of simultaneous connections. containment measures were applied in medical establishment for dependent older adults for dependent older adults (ehpads), where the circulation of the virus was particularly harmful. older adults were initially confined to their rooms, without visiting rights, and these measures were recently relaxed, with permission for visits without physical contact. the french government conferred a broadening of competences and recognition of the role of home care nurses. the health context made it possible to create the first telecare procedure related to the management of patients with covid- by home nurses during the period of the state of health emergency (high authority of health ; prime minister of the french government c). for the duration of the epidemic, a patient diagnosed with covid- could benefit from telecare on prescription, as long as the patient guarantees their availability and mastery of the tele-monitoring tools (smartphone, computer with wi-fi connection, or, failing that, telephone). telecare would be fully covered by the french health insurance. before any care was provided to the patient with covid- , a nurse collected general information and the care plan prescribed by the doctor for the patient (e.g. points of vigilance, monitoring rhythm). during the first contact, the nurse assessed the patient to confirm the criteria for inclusion in the telecare system, supplemented by measures related to the current situation and, in particular, the implementation of hygiene and prevention measures for the family caregiver. then, as part of the follow-up set-up according to the severity of the patient's condition as indicated by the doctor, the nurse carried out the following: determining the patient's general condition, looking for signs of worsening symptoms, collecting clinical observations at a distance (e.g. temperature, weight), looking for signs of altered consciousness, looking for signs of dehydration, reminding the family and friends of the hygiene and prevention instructions, coordinating with the doctor regarding an alert without delay if the patient's condition required it, or call for emergency medical assistance in case of distress, in parallel with the information from the doctor. if the nurses considered that the conditions would no longer enable them to carry out the follow-up, they would then go to the patient's home to carry out face-to-face monitoring and inform the attending physician, who will adjust the prescription for nursing follow-up as necessary. this new system, requested by the order of nurses, made it possible to monitor patients while drastically reducing exposure to the risk of contamination for caregivers. if telecare was not possible for patient follow-up, and to avoid the risk of spreading the coronavirus within home nursing structures, nurses could opt to follow-up their patients at home, even without specific instruction from the medical prescription. the related procedures were subject to specific coverage and price re-evaluation by the health insurance. prolonged containment can have several implications for the health of the population. the first concern to be feared was the impact on mental health, brought by social isolation, fear of illness and uncertainties in relation to the illness. a survey was conducted by sant e publique france with a sample of internet users to characterize the impact of covid- on the general population and to influence the political measures to be implemented to care for the population (french public health b). because the abovementioned repercussions may be more severe for people with disabilities, particularly psychiatric disorders, specific measures were recommended by the high council of public health ( a) to adapt containment measures to the problems of each person concerned. these containment measures were applied in ehpads, where the circulation of the virus was particularly harmful. the second concern was that a large, difficult-to-measure proportion of the french population seemed to have given upon their usual, acute or chronic care, mainly because of covid- containment measures and the fear of being contaminated. according to a recent survey by a telemedicine platform, the number of consultations with general practitioners decreased by % since the beginning of containment, and by % for specialist physicians (doctolib ) . to date, the effects of this situation remain difficult to assess, especially for people with particular health vulnerabilities. meanwhile, paediatricians alerted the authorities to the decrease in the number of families requesting paediatric consultations, particularly for consultations in connection with the programming of children's vaccinations (french association of outpatient pediatricians ). the risk of a resurgence of infectious diseases in children is becoming significant because it is not possible to identify the proportion of children who are not vaccinated according to the vaccination schedule issued by the high council of public health. third, confinement unfortunately endangers a certain number of women and children who are victims of domestic violence (usher et al. ) . the french government ( ) widely publicized the possibility of contacting a telephone hotline to report situations of violence. recently, these reports have doubled; however, it is difficult to obtain reliable data to date to estimate the number of collateral victims in confinement. for these reasons, the government has wished to introduce deconfinement for children, who seem less sensitive to the virus, so that a certain number of them can return to school, eat at least one balanced meal a day and escape intrafamily contexts that are harmful to them. finally, several french nurses faced threats or were subjected to malicious acts, often anonymous, by neighbours in particular: posters or anonymous letters asking the nurse to move to avoid contaminating an entire residence, vandalism on personal vehicles or in professional premises, theft of equipment and assault. the french national council order of nurses ( a) assisted nurses who were victims of these malicious acts in legal proceedings. gradual deconfinement was being implemented as of may (prime minister of the french government d). the national deconfinement strategy was based on three main principles: protecting the population through barrier gestures and the wearing of masks in certain situations, testing the population on a large scale and isolating sick people and contact cases. departmental (territorial division in france) maps were established to report on situations that may or may not be conducive to deconfinement, according to three main indicators: the rate of new cases in the population over seven days, hospital resuscitation capacity, and organization of the local testing and contact case detection system. the deconfinement plan announced the opening of some public places, including schools, but advised the maintenance of teleworking as much as possible. new rules for social life were also introduced. if the indicators were unfavourable, then a department would not be deconfined. two phases were planned: a first period of deconfinement from may to june , followed by a second period before the summer holidays. despite the exceptional purchasing and requisitioning measures by the french government of personal protective equipment (ppe) and other urgent health supplies, caregivers were left with a real lack of protection, as was the case elsewhere in the world. france was counting on its main supplier, china, without foreseeing that if china itself was exposed to a health crisis such as covid- , stocks of chinese products would then be used primarily by china. to obtain more precise information on the situation, the french national council order of nurses ( b) carried out an online consultation from april to april , in which more than nurses participated (a sample of % of the french nursing population). the main results were as follows: • nearly three-quarters of the nurses consulted stated that they did not have enough ppe. • of the nurses consulted, % said they did not have enough gowns, and % said they did not have enough masks. • of the nurses consulted, more than two-thirds ( %) stated that they did not have enough protective goggles. • more than half ( %) said they did not have enough overshoes. • more than half ( %) stated that they did not have enough mob caps. • nearly half ( %) stated that they did not have a sufficient quantity of hand sanitizers. the french state set up an emergency system for the purchase of ppe. it has been able to count on the solidarity of the french population and companies, which, on a voluntary basis, have developed the production of masks, gowns and hand sanitizers, although this was not their primary function. to date, french studies on covid- have been referenced in clinical trials, of which are in the process of gathering participants. these studies cover the epidemiology of covid- , clinical trials of drug treatments and their side effects, and the effects of containment. different drug strategies are being investigated, and the results of these studies are expected to be published soon. the results of these studies are eagerly awaited by the french government, by the scientific community, as well as the population. france has suffered a very high toll in terms of covid- morbidity and mortality, and adverse effects on its people, economy, health systems and health professionals, including nurses. the context of the health crisis caused by covid- in france is leading to strategic and political changes on a daily basis. health professionals in hospitals and primary care facilities are in the front line of the health management of the crisis. however, the population, through political decisions, has a duty to support healthcare workers to reduce the circulation of the virus. after a confinement of almost two months, france is preparing to live a new life, partly deconfined, but with new habits to implement, and above all, a deep reflection on the aftermath of the pandemic. nurses play a key role in the context of the covid- health crisis, in hospitals, medical and social care institutions and primary care. the public is largely grateful for nurses' involvement and dedication in this context. although public gratitude may bring satisfaction and value to the profession, the collateral effects of this crisis on the nurses themselves need to be studied. the authorities likewise need to ensure that nurses remain in their profession. derogating measures that would extend the scope of nursing activities during crises also need to be considered to develop and establish them on a permanent basis in nursing practice. it would be inappropriate to withdraw recognized skills acquired during the crisis once the crisis is over. the french concerns are completely in line with the global concerns raised by the international council of nurses (icn), which calls for the recognition, respect and protection of nurses (international council of nurses a). the context of this health crisis places the nursing profession in a social mandate recognized by the french population. it is imperative that nursing practice be adapted and evolved so that france can win the fight against this virus. the french national council order of nurses ( c) has asked the french government to deploy several means to help nurses accomplish their daily mission: an intensification of efforts to equip nurses working in residential institutions for dependent older people, medico-social establishments or at home with ppe and systematic screening of health personnel; additional efforts to promote tele-nursing; the introduction of differentiated spaces and rounds of home visits (covid- /non-covid- ); a more efficient system to ensure the quality and continuity of care for all, particularly for at-risk populations and those suffering from chronic pathologies; a strong fight against any malicious act or discrimination towards healthcare workers with regard to their employment and the covid- risk; the possibility for nurses to carry out the entire procedure relating to releasing death certificates instead of a doctor; and the prescription of covid- tests. the french national council order of nurses has also called for an accurate count of nurses infected with and died from covid- , the recognition of occupational disease for infected caregivers, and the granting of the status of ward of the nation for the children of deceased nurses. these latter concerns appear to be global, as the icn also notes that the number of nurses who died from covid- appears to be underestimated (international council of nurses b). these requests were made during the time of the covid- crisis, but the french national council order of nurses asked the french government to rethink completely its vision of the nursing profession. today, the nurse is an essential link in the patient's care journey. the nurse is a clinician, and this must be reflected in a progressive evolution of nursing skills to include skills regarding medical prescription. the international council of nurses has positioned itself to ensure that the critical role of nurses in the management of covid- , as well as in day-to-day operations, is fully recognized by governments around the world (international council of nurses c). the state of the world's nursing report provides a basis for reflection on the evolution of the nursing practice and better recognition of nurses in all countries (who f). covid- : doctolib alerts on drop in practice attendance and commits to allowing patients to return for consultation press release april. available at protecting children, continuing to care for them in the midst of the pandemic (in french) the government fully mobilized against domestic and intra-family violence the order assists nurses who are victims of pressure or aggression in their legal proceedings (in french) covid- : the national order of nurses alerts on the situation of the profession and announces new emergency measures (in french) the national order of nurses makes recommendations for priority measures for deconfinement (in french) covid- france covid- : a survey to monitor behavioural and mental health changes during confinement rapid responses under covid- teleconsultation and telecare epidemic at covid- : support for people with disabilities (in french). notice international nurses day: nurses deserve praise, thanks, protection amid covid- . press release may icn says worldwide death toll from covid- among nurses estimated at may be far higher international council of nurses: nursing the world to health prime minister of the french government . introduction of the emergency law to deal with the covid- epidemic address transcript march assistance in organising the provision of care in exceptional health situations (in french) three cases of coronavirus ( -ncov) infection in france (in french) covid- : a twelfth case confirmed in france (in french) order of march laying down various measures to combat the spread of the covid- (in french). regulatory text march ministry of solidarity and health d. order of march on the mobilization of the health reserve (in french) ministry of the army . operation resilience (in french) address to the french population address to french population as an emergency measure to deal with the covid- epidemic decree no. - of march prescribing the general measures necessary to deal with the covid- epidemic within the framework of the state of health emergency (in french). regulatory text march decree no. - of adopting adapted conditions for the receipt of cash benefits for persons exposed to coronavirus (in french). regulatory text march presentation of the national deconfinement strategy (in french) family violence and covid- : increased vulnerability and reduced options for support who health emergency dashboard who (covid- ) homepage world health organization b. coronavirus disease (covid- ) pandemic who director-general's opening remarks at the mission briefing on covid- rector-general-s-opening-remarks-at-the-mission-briefing-on-covid covid- situation in the who european region who director-general's opening remarks at the media briefing on covid- state of the world's nursing report - firstly, we thank all nurses in france, from all sectors of activity, for their involvement in this covid- crisis. secondly, we thank the french national council order of nurses for the financial support for the linguistic revision of this article. manuscript design: sc data collection: pc, cr, sc manuscript writing: pc, cr, sc critical intellectual revisions of manuscript: pc, cr, sc key: cord- -ftcs fvq authors: o’reilly-shah, vikas n.; gentry, katherine r.; van cleve, wil; kendale, samir m.; jabaley, craig s.; long, dustin r. title: the covid- pandemic highlights shortcomings in us health care informatics infrastructure: a call to action date: - - journal: anesth analg doi: . /ane. sha: doc_id: cord_uid: ftcs fvq nan s evere acute respiratory syndrome coronavirus- (sars-cov- ), the causative agent of coronavirus disease (covid- ) , was designated a pandemic by the world health organization on march , . by that date, hundreds of thousands of people around the globe had been infected, and millions more are expected to suffer physically and economically from the effects of covid- . scientifically, the pace of progress toward understanding the virus has been dramatic and inspiring: the viral genome was rapidly determined, and a . -angstrom-resolution cryoelectron microscopy structure of the viral spike protein in prefusion conformation was published within weeks of its identification. initial small trials examining the impact of potential therapeutic agents have also been rapidly published; to date, more than clinical trials have been registered, including several for candidate vaccines. in contrast, other aspects of the international covid- response have not yet demonstrated similar progress. the need for rapid aggregation of data with respect to the epidemiology, clinical features, morbidity, and treatment of covid- has cast in sharp relief the lack of data interoperability both globally and between different hospital systems within the united states. this global scale event demonstrates the critical public health and research value of data availability and analytic capacity. specifically in the united states, although efforts have been made to secure the interoperability of health care data, countervailing forces have undermined these efforts for myriad reasons. in this study, we describe these forces and offer a call to policy action to ensure that health care informatics is positioned to better respond to future crises as they arise. efforts to develop a standard for health care data exchange have a long history, but the most promising arose from the passage of the health information technology for economic and clinical health act of (hitech). hitech created an economic motivation for the implementation of electronic health records (ehr) across the united states and is, for this purpose at least, widely viewed as successful. by , % of small rural hospitals and % of office-based physician practices possessed certified health information technology. notably, the staged approach to ehr adoption delayed interoperability requirements until the final stage of adoption. in the competitive us ehr vendor market, this delay led to differences in how vendors approached and implemented interoperability. although it appears that there is general consensus on the use of the substitutable medical apps, reusable technologies on fast healthcare interoperability resources (smart on fhir) standard developed by the nonprofit health level seven international (hl ) for the interchange of data, the standard is not specific enough to ensure, and regulators have failed to require, that different vendors implement the specification in compatible ways. this failure has necessitated the development of health care integration engine software products to bridge the gap, yet another source of financial inefficiency in us health care. furthermore, aspects of the smart on fhir specification remain incomplete. for example, there is no implementation guide for intraoperative anesthesia data, although one may be developed by . it is notable that the hl development work in anesthesiology is done entirely by volunteers. the interoperability framework offered by smart on fhir is, by itself, not sufficient for public health and research purposes. smart on fhir is specifically designed for patient-level data sharing. in the absence of regulations that mandate a specific solution, academicians have developed approaches to the organization and dissemination of standards that allow for multicenter data analyses. the observational health data sciences and informatics (ohdsi), a collaborative group of investigators mostly funded by public granting agencies, is presently in the sixth version of its observational medical outcomes partnership (omop) common data model. once an organization transforms its data into the omop model, as many have, it can participate in data analysis with any number of arbitrary partners through a federated mechanism. as with hl , there is no standard in omop for anesthesiology data, and standards for data from critical care environments remain underdeveloped. within anesthesiology, the multicenter perioperative outcomes group offers arguably the most comprehensive candidate common data model, although costs of participation are high, and most participating sites are academic centers. while the lack of standard specification by regulatory agencies has contributed to these challenges, emr vendors themselves have also played a role. exposing standardized data reduces barriers to adoption of competing ehr platforms, which clearly explains the reticence of vendors to do so. this year, the chief executive officer of a dominant us ehr vendor wrote a letter in which it urged its customers to oppose proposed regulations that would simplify the sharing of patient data; perhaps unsurprisingly, vendors with less market share and other companies attempting to enter the space voiced support for those same regulations. [ ] [ ] [ ] amidst the covid- crisis, further delays in regulatory implementation are under consideration at the very time that data sharing is urgently needed. it is worthwhile to note that the widespread penetration of ehrs into hospital systems facilitated by the hitech act did allow individual systems to react and adapt to the covid- pandemic in intelligent, data-driven ways. as an example, uw medicine-one of the first health care systems in the united states to encounter the disease-developed a comprehensive set of information technology solutions in response to the pandemic, including order sets, documentation templates, and dashboards. the value of the ability to rapidly collate and present information at the institutional level should not be underestimated, even as the potential benefits of interinstitutional data sharing during a pandemic remain as yet unrealized. the framework of proportionality is helpful for considering the ethical ramifications of broad data sharing, especially as seen through the lens of a pandemic. it is critical to balance the probable public health benefits of an intervention with the potential infringements on patient privacy or autonomy. the many benefits of real-time data sharing in the context of a global health care emergency have already been outlined. to briefly recap, if hospitals across the country were able to observe and interpret data being gathered at other institutions in real time and to contribute their own data to the shared repository, the health care system could be learning about and improving its care of covid- patients continuously and collaboratively, based on the sum total of available information rather than incrementally in silos. even as biomedical publishing gradually evolves to become more agile and rapid, traditional approaches to medical knowledge creation and dissemination remain unacceptably slow and continue to permit the dissemination of inaccurate information in the midst of a pandemic. indeed, calls have been made to address the ongoing "infodemic" (as it has been dubbed by the world health organization). additionally, the sharing of data across health systems would hold hospitals accountable for providing care that is consistent with agreed-upon ethical principles during public health crises, such as allocating treatments in ways that maximize the number of lives saved and treating patients equitably with regard to race, ethnicity, and insurance status. who would monitor and report back on such issues? the us centers for disease control national healthcare safety network (nhsn), established to gather data on (primarily bacterial) health care-associated infections, provides a model for centralized aggregation and reporting but would require heavy revision for our purposes. because the system relies on manual case review and entry, data captured are delayed and results are aggregated on a quarterly basis, too slow and too error prone in the context of a rapidly evolving pandemic. the centralized approach also introduces concerns related to oversight and performance penalties, as well as barriers to use by academic researchers. unlike the nshn, such a system would need to automate aggregation to real-time or near realtime status, provide mechanisms to allow research use of data, provide systems for deidentification of data and protections against reidentification of patients, and potentially be firewalled from traditional quality and pay-for-performance reporting purposes to maximize public health surveillance and research capabilities. potential harms that must be considered include breaches of patient privacy, premature decisionmaking based on preliminary or inaccurate information, and the potential misuse or misinterpretation of shared data. privacy concerns have been raised by ehr companies and health care providers as a major reason not to enter into data-sharing agreements. while it is true that the risk of data breaches might increase with increased interoperability, they need not necessarily become more probable. effectively implementing safeguards around encryption, authentication, and data use can mitigate these risks (the risk of ehr data exposure is not, eg, uniquely greater than financial data compromise), which must be balanced against the potential benefits to patients and public health. there are few remaining legal barriers to the sharing of health information. however, legal, ethical, and logistical challenges arise when a health care system houses data that are not necessarily from that system's patients. large institutions may serve as reference laboratories for broad geographic areas and therefore house assay data from external clients that may or may not have agreed to this type of data sharing. indeed, without careful handling, inclusion of outside clients' results, when combined with data from other regional systems, may lead to unrecognized data duplication. institutions must also consider how they will manage and protect the data generated from testing their own employees in the context of a pandemic. apart from legal restrictions on handling of employee health information that stand apart from health insurance portability and accountability act (hipaa) restrictions, there are ethical challenges in understanding how these data might best be used to study the risks to health care workers while also respecting health care worker privacy. on balance, the ethical obligation, then, is for the companies facilitating data sharing and/or storage to ensure their systems meet the highest standards for security. by contrast, risks to privacy may actually be increased as long as ehr systems are not interoperable, given that patient data may be scattered across multiple systems. other risks that may accompany the sharing of real-time clinical data should be acknowledged. for example, the information itself may be inaccurate due to charting errors or coding inconsistencies. decisionmakers may jump to premature or biased conclusions based on apparent associations between an infectious disease and groups that have been the object of adverse implicit or explicit association bias (eg, racial and ethnic groups, homeless, prisoners, sex workers), leading to further stigmatization and limited access to care. such risks might be increased in the setting of a global crisis characterized by a rapidly spreading virus, widespread fear, and unreliable media sources. on balance, however, our view is that there are no public health benefits to the status quo. proprietary control over ehr data benefits only ehr vendors themselves-who profit from institutional contracts and inhibitors to marketplace competition-and their customers-who may retain patients by virtue of limited or absent interoperability. the harms of the status quo include increased health care costs, such as duplicate testing when records are not transferable. the failure to implement interoperable health care records may also harm patients by trapping their data in balkanized systems, keeping physicians from accessing needed information in an efficient manner. access to prior documentation of critical conditions (eg, a difficult airway or history of malignant hyperthermia or critical aortic stenosis) would allow anesthesiologists to make safer, more efficient diagnostic and care decisions. frontline providers shouldering the burdens of health care under pandemic conditions are rapidly realizing that competent physicians and other health care workers can only go so far to solve problems that arise from systemic dysfunction. lack of data infrastructure inhibits communication and study of rapidly evolving clinical practice. hospitals within blocks of each other are relying on ad-hoc interpersonal communications rather than working from a coherent multiorganizational playbook. the seamless capability to share ideas, care plans, and experiences based on reliable data would dramatically alter the us health care landscape. on a smaller scale, interoperability challenges also exist within hospital systems or single hospitals themselves. lack of data interoperability at the device level has ensured that hospital systems have to navigate and manage streams of data from diverse legacy devices, creating challenging data acquisition issues in the context of a surging number of covid- cases. www.anesthesia-analgesia.org anesthesia & analgesia covid- and data infrastructure shortcomings when confronted with a novel disease process, small and often poorly conducted studies rapidly proliferate. these studies are disseminated in mass and social media and may drive therapeutic decisions that could be ineffective at best and cause substantial harm at worst. in the context of covid- , a context where millions have contracted the disease and hundreds of thousands will likely die, timely but robust science is needed. the ability to share and combine data across systems serves as the foundation of such efforts. with data standardization and sharing, variability in care approaches could be harnessed to identify best practices and therapeutic avenues in a much more cohesive, data-driven manner. several concrete examples are illustrative. infection control procedures and equipment or medication shortages related to covid- are significantly impacting the timing of surgery, default approach to airway management, maintenance of anesthesia, and the setting in which postoperative monitoring occurs. such rapidly developed policies are intended to protect anesthesia providers and other health care workers and to conserve critical resources, but is there a signal for patient harm associated with such sudden and profound changes in practice? additionally, anesthesia departments are increasingly relying on the results of preoperative sars-cov- testing to guide such policies. the efficacy of these screening systems (particularly when applied to asymptomatic patients or those in whom such a determination is not possible) is unknown but is of critical importance for airway management, for determining personal protective equipment requirements during anesthetic care, and for determining safe postoperative disposition. collectively, surgical patients undergoing preoperative evaluation are poised to become the largest cohort of asymptomatic patients tested for sars-cov- , and yet the power of this potential resource to broadly inform health care policy will likely go unutilized. unexpected but fundamentally important aspects of this emerging disease, such as the large number of patients presenting for endovascular therapy for acute ischemic stroke, may be uncovered through coordinated approaches to discovery. finally, there has been a rapid shift toward the use of anesthesia machines to meet surge demands for mechanical ventilation. reasonable evidence exists to suggest that modern anesthesia machines are virtually indistinguishable from intensive care unit (icu) ventilators; however, icu ventilators are more fault tolerant, handle circuit leaks more optimally, and handle fresh gas in very different ways. anesthesia machines set improperly and operated by health care providers unfamiliar with their use may unnecessarily waste medical gases or (in the worst case) deliver hypoxic gas mixtures in the context of inadequate oxygen flow into the circle system. again, the impact of such a rapid retasking of medical equipment will, under the current infrastructure, remain unknown for much longer than should be necessary. the public has a pressing interest in ensuring that data standards (eg, omop, fhir) are rapidly developed, adopted by appropriate international standards organizations (eg, hl ), and implemented by ehr vendors in a manner that facilitates interoperability for individual patient care, public health, and research purposes. we agree with others that this will require changes to the regulatory environment created by the hipaa. anesthesiologists, along with nurses, respiratory therapists, advanced practice providers, emergency room physicians, intensivists, and other critical care professionals, stand at the front line of the covid- public health crisis. better data are required to delineate every aspect of this pandemic: supporting local operations and quality work; informing research queries, such as investigations into provider risk following airway management and quantifying the efficacy of therapeutic options; and bolstering public health efforts by providing real-time prevalence, tracking disease spread, and facilitating risk stratification. integration of health care data with nonhealthcare source data is currently an impossibility in the united states due to lack of a universal health care identifier. public funding agencies and their grantees have shouldered the burden of creating stopgap solutions that policymakers have failed to require and major ehr vendors have avoided due to risk of competitive disadvantage. policymakers and funders are called upon to prioritize the modernization of health informatics. anesthesiologists and our specialty societies are called upon to advocate policymakers for these changes and to involve themselves in these organizations in the coming months and years and contribute to development or otherwise risk failing again in optimizing a data-driven response to the next pandemic. e a new coronavirus associated with human respiratory disease in china cryo-em structure of the -ncov spike in the prefusion conformation search of: covid- -list results -clinicaltrials the office of the national coordinator for health information technology. health it quick stats g . best healthcare integration engines software in . available at hl international. anesthesia -documents. available at epic's ceo is urging hospital customers to oppose rules that would make it easier to share medical info cerner growing ehr market share with increased hospital consolidation: klas. fiercehealthcare cerner call for interoperability rule release hhs considers rolling back interoperability timeline amid covid- . healthcare dive responding to covid- : the uw medicine information technology services experience teaching seven principles for public health ethics: towards a curriculum for a short course on ethics in public health programmes pseudoscience and covid- -we've had enough already truth in reporting: how data capture methods obfuscate actual surgical site infection rates within a health care network system legal barriers to the growth of health information exchange-boulders or pebbles? anesthetic management of endovascular treatment of acute ischemic stroke during covid- pandemic: consensus statement from society for neuroscience in anesthesiology & critical care (snacc)_endorsed by society of vascular & interventional neurology (svin) perioperative documentation and data standards--anesthesiology owned and operated balancing health privacy, health information exchange and research in the context of the covid- pandemic the us lacks health information technologies to stop covid- epidemic the authors declare no conflicts of interest.reprints will not be available from the authors. key: cord- - knig g authors: thacker, s.b.; sencer, d.j. title: centers for disease control date: - - journal: international encyclopedia of public health doi: . /b - - . - sha: doc_id: cord_uid: knig g emerging from a small, wartime government program with a regional focus on malaria in , the centers for disease control and prevention (cdc) has become a global public health agency that addresses the entire scope of public health, with over employees and contractors in nearly occupations. the cdc's expertise has expanded in direct correlation with the expanding view of public health needs: it is recognized globally for its ability to respond to urgent threat related to disease epidemics and the health consequences of disaster and war. cdc programs have contributed significantly to the eradication and reduction of diseases such as smallpox, polio, and guinea worm, as well as the control of health problems such as human immunodeficiency virus (hiv), childhood lead poisoning, breast and cervical cancer, diabetes, violence, and unintentional injuries. cdc contributions in applied epidemiology, public health surveillance, risk factor reduction, and environmental risk assessment also have been critical to the practice of public health in the united states and around the world. the emerging concerns of the new century – genomics, globalization, the built environment, information technology, global warming, emerging infections, violence, and so forth – will require not only the traditional disciplines but also new expertise and new global partners, both public and private. the history of the centers for disease control and prevention (cdc) began in with the establishment of the malaria control in war areas (mcwa), under the u.s. public health service (phs). the u.s. military had suffered severely from malaria during world war i, and although the reported incidence had dropped during the s, a cyclical -to -year pattern of disease raised concern. because the disease had been endemic in the southern united states, concern was heightened because military bases and more than essential war establishment facilities were located there. mcwa was the actualization of the vision of joseph w. mountin, md ( - , an assistant surgeon general in the phs and director of the bureau of state services, who reported to the surgeon general of the phs. the headquarters was located in atlanta, georgia, with close associations with state health departments, puerto rico, and the virgin islands, as well as laboratory facilities and field stations in multiple states that worked with all the affected states and territories. although the phs provided leadership for the new program, much of the expertise in malaria had been recruited by the military; therefore, substantial training became an essential component of the multifaceted approach taken by mcwa. physicians assessed clinical malaria and parasitologists managed the laboratories; however, mosquito control was the emphasis, and engineers and entomologists dominated mcwa. field staff from the recently terminated works progress administration were recruited to continue their work of draining malaria breeding grounds and larviciding with diesel oil and insecticides (beginning with paris green but adding ddt in , which substantially changed the approach to malaria control). state laboratory staff were trained to diagnose malaria by using the most effective techniques. the program's scope expanded to the civilian population and to other vector-borne diseases such as dengue and typhus. mwca laboratory workers also responded to requests from states for assistance in epidemic investigations, a role previously left to the national institute for health (nih) (now the national institutes of health). the mcwa program was regarded as highly successful, and even before the end of the war, mountin and his staff were considering the future. with the support of surgeon general thomas parran, jr. (surgeon general, - ) , the communicable disease center was established on july , . at the time, cdc had employees and a budget of $ . million ( table ) . the legislation that created the cdc explicitly charged the new agency with responsibility for dealing directly with state health departments in the control of communicable diseases. this role was solidified in when the association of state health officials and the american public health association agreed that cdc take the lead in defining what diseases were of highest priority and should be reportable. the key figure in this expansion of the cdc role was alexander d. langmuir, md ( - ) , who was brought to the cdc in as chief of the epidemiology division. langmuir brought experience as a member of the armed forces epidemiology board, as a practicing epidemiologist at both the local and state health departments in new york, and as a professor teaching at the johns hopkins school of hygiene and public health. he also brought vision and a strong personality that helped bring the role of the epidemiologist to prominence at the cdc and in public health practice throughout the country. the cdc expanded during those first years to include field stations in missouri, colorado, and texas, and to conduct special studies in other states. influential events and decisions in the s, however, truly established the cdc as an agency with national recognition, and mountin and langmuir were forces behind the majority of these changes. in , the cold war set the tone in international affairs, and the korean conflict fueled a concern about the pointed use of biologic weapons there and in the united states. langmuir successfully championed the concept of the epidemic intelligence service (eis), which would respond to disease outbreaks as part of a program of biologic warfare defense. the eis program was established in with the recruitment of men, including physicians and a sanitary engineer. this first class became the disease detectives, the symbol of applied epidemiology practiced at the cdc and the core of epidemiologists who would come to lead the agency in future years. by , more than men and women had graduated from the program, all with different backgrounds and experiences. together they have conducted more than investigations, not only in infectious disease but also in chronic diseases, injury, and the many other health areas that the cdc has engaged in during subsequent years ( table ) . eis alumni have become public health leaders at the cdc, throughout the united states, and around the world. the event that first brought national attention to the cdc came with poliomyelitis, the crippling childhood disease. in , more than cases were reported in the united states, and polio was the leading infectious cause of childhood death in the country. in , the university of michigan conducted a national randomized trial of the killed virus vaccine developed by jonas salk on more than u.s. school children during a year when more than cases had been reported. the positive results were announced on april , , the tenth anniversary of the death of franklin delano roosevelt, and the response was dramatic. within hours, surgeon general leonard a. scheele (surgeon general, - ) announced a national vaccination program. unfortunately, however, on april of that year, a baby was reported to have contracted polio days after vaccination; this proved to be the index case of an epidemic of vaccine-associated polio that led to a decision to shut down the program. four days later, langmuir was directed to establish the national polio surveillance unit he had been advocating, and he immediately directed the eis officers to focus their efforts on this national emergency. within less than a week, daily reports were produced by the epidemiologists in the unit. rapid investigation in the field and in the laboratory clearly implicated one of the five vaccine manufacturers as the source of the epidemic (although a second manufacturer might have had problems as well). weeks later surgeon general scheele was able to announce that the problem had been identified, safety standards had been instituted, and the vaccine was now safe to distribute. the cdc's role had been critical, and the importance of public health surveillance and of the eis was recognized. national surveillance for asian influenza in - , together with the work of cdc epidemiologists and laboratory staff, cemented the national role of the agency in disease control. the second major event of the decade was less obvious to the public -the transfer of the phs venereal disease division (vdd) to the cdc in . at the time the vdd had a larger budget than the cdc and certainly a longer history. however, the effect was more important than the budget. the vdd brought with it a grant program that distributed money to states and a program management function -the public health advisor. the grant program enhanced the agency's connection and collaboration with state health departments, and the public health advisor became the primary nonscientific manager of cdc programs and of the agency itself. another program that came to the cdc with the vdd -unfortunately one that was highly negative -was the tuskegee study of the complications of syphilis, which had begun in table centers for disease control and prevention (cdc) timeline among black men in rural alabama. although the gravity of this study was little recognized in , the matter became public in and led to a formal apology by president william j. clinton in . the cdc moved into new facilities adjacent to the emory university campus in . at the time, the cdc had more than employees and a budget of $ million. the expansion of the agency mission was equally substantial. by the end of the decade, the budget had reached $ million, and the cdc encompassed programs in immunization, hospital infection control, tuberculosis, and environmental health. the journal morbidity and mortality weekly report (mmwr) was brought from the national office of vital statistics to the cdc by langmuir in . the publication rapidly became the agency's premier publication and the avenue for publishing concise, science-based articles of current events of public health interest such as epidemics, as well as current data regarding disease occurrence and death. the cdc increasingly was recognized for its responsiveness to epidemics of infectious diseases, including drug resistance among hospitalized patients, salmonella in commercially produced chicken, polio associated with oral vaccine, and for its international work in smallpox eradication and disaster assistance. the cdc also maintained its lead federal role in disaster assistance, and staff studied the immediate and long-term health effects of such disasters as hurricane camille in . possibly, the most important event for the cdc during that decade, however, occurred in geneva at the world health assembly in when the world health organization (who), under the joint leadership of the united states and the united soviet socialists republic, endorsed the plan to eradicate smallpox. this political will, together with improved technology (e.g., the jet injector gun to deliver vaccine), was the impetus for an extraordinary global program. donald a. henderson, md (eis ) , was transferred to who to help lead the international effort. a global mass-vaccination strategy was undertaken, and active surveillance documented rapid decreases in illness and death. however, the program began to founder and eradication appeared out of reach. william h. foege, md, another eis alumnus ( ) , demonstrated in west africa that an active surveillance and containment strategy was an effective complement to the mass-vaccination strategy. in , these efforts resulted in the first successful eradication of a human disease in history, years after the last case of wild-strain smallpox in somalia. the cdc's global role in disease control was founded on its active role in smallpox eradication. two future cdc directors, foege and jeffrey p. koplan, md, who had served as an eis officer ( ) in the program, and dozens of future public health leaders and hundreds of public health workers domestically and internationally were trained in this effort. the critical role of epidemiology and public health surveillance was now recognized by a much broader audience, and the importance of international, cross-disciplinary, and cross-cultural collaboration was appreciable. the s brought further change to the cdc and initiated its programmatic expansion to broader areas of public health, including environmental health, additional chronic diseases, occupational safety and health, and injury prevention and control. the cdc's expansion in part came from the transfer of programs in these areas, notably the national institute for occupational safety and health, which was transferred in . other expansions resulted from calls for assistance from states or other federal agencies. childhood lead poisoning was being reported as a result of industrial pollution or from parents bringing lead home on their work clothing. vinyl chloride-associated liver cancer was demonstrated in population studies. investigating the short-and long-term effects of exposure to radiation after the incident at the nuclear reactor at three mile island in pennsylvania was initiated at the end of the decade. a collaborative study with the national cancer institute was conducted to investigate the association of cancer with both oral contraception and estrogen therapy. all these changes provided background for major organizational changes that occurred at the end of the decade. meanwhile, the cdc continued to have active engagement in infectious diseases. the identification of salmonella among pet turtles altered that industry, as did discovery of the contamination of commercial intravenous preparations with bacteria and the subsequent documentation of a nationwide epidemic leading to a product recall. the study of the efficacy of nosocomial infection control (senic) confirmed the effectiveness of hospital infection-control practices. internationally, the cdc was involved in documenting the threat of hemorrhagic fever viruses -first the marburg virus in germany, and subsequently the lassa and ebola viruses in sierra leone, zaire, and sudan. two events in , the agency's th year, however, might have had the most enduring impact. in spring , an outbreak of influenza at a military base in new jersey was identified as being caused by a new strain of influenza a, a strain that was quite different than the strain (a/hong kong/h n ) circulating since . the new strain (h sw n ) had demonstrated pathogenicity among humans and its ability to be transmitted person to person, circumstances that were believed to always lead to pandemics. as important, this strain was believed to be closely related to the influenza virus that had led to a pandemic in - , which had killed u.s. residents and an estimated million persons globally, affecting particularly young adults. with the cdc in the lead, scientific experts were engaged during the following months to study the problem. they ultimately recommended the policy that led to the national influenza immunization program, which targeted the entire u.s. population. vigorous efforts by the president, congress, the vaccine manufacturers, and the public health system enabled the program to begin in october . within weeks, the cdc's national surveillance program, in collaboration with the states, uncovered an increased reporting of guillain-barré syndrome among persons who had been vaccinated during the program. subsequently, the program was suspended and no epidemic occurred. an association was confirmed in a national case-control study conducted by the agency; the agency was criticized harshly, and other vaccination programs were called into question. in early august , a report from pennsylvania of possible swine influenza led to an investigation of fatal pneumonias among veterans and their families who had attended a statewide convention of the american legion in philadelphia during the third week of july. the legionnaires' disease epidemic eventually brought eis officers and many other staff to pennsylvania and stayed on the front pages for weeks during this bicentennial year. by the end of august, the field team had identified more than cases -laboratory staff had ruled out all known human pathogens -and together they had investigated multiple leads in an effort to determine a toxin. terrorism was considered, and external experts were called in. however, the strongest association identified was with the hotel that had housed the conventioneers and had hosted major business and social activities. the team returned to atlanta without a definitive answer, and in the context of the mounting criticism around the swine influenza program, continued its work. finally, in december, joseph e. mcdade, phd ( -) , in the cdc's rickettsial diseases laboratory, identified the gram-negative rod that proved to be the bacterium that caused the epidemic. legionella pneumophila became the first new human bacterial pathogen identified in decades, and mcdade and his coworkers linked it to two previously unsolved epidemics in and . the s was dominated by the epidemic caused by hiv, but the cdc was also to undergo another major organizational change that reflected a new direction for the agency. however, the decade opened with two investigations of a more traditional nature that brought national visibility to the agency and brought lawyers into the public health policy arena in a dramatic fashion. in the summer of , a report from arizona in the mmwr linked reye's syndrome with using aspirin. that report was followed by similar data from ohio and michigan, which led the cdc to conclude that the association might be real. the aspirin industry aggressively attacked, but the cdc held firm and recommended that aspirin be avoided for children with chickenpox and during influenza epidemics. surgeon general julius b. richmond ( - ) soon followed with a similar recommendation. the struggle with industry did not stop, but national data demonstrated a noticeable decrease in reye's syndrome during the next few years. meanwhile, the cdc was responding rapidly to the national epidemic of toxic shock syndrome among women. within months, the disease was linked to use of tampons and by the end of , specifically to the use of the rely tampon, made by proctor and gamble. after the manufacturer voluntarily withdrew the product, the epidemic abated dramatically. major change was continuing to happen in public health, and the cdc was involved in measuring the health effects of the radiation release from the nuclear reactor at three mile island in pennsylvania, the toxic effects of dioxin at love canal (new york) and among vietnam war veterans, and the volcanic eruption at mount saint helens (washington state). the chemical release in bhopal, india, and the investigation of toxic oil syndrome in spain reflected the international recognition of the cdc in environmental health. in , the agency announced a reorganization to reflect these new public health concerns and environmental health, chronic diseases, occupational health, unintentional injuries, violence, and maternal and child health, while maintaining excellence in the prevention of infectious diseases. this reorganization enabled the programmatic growth for the next two decades. however, a brief report of an unusual pneumonia among five homosexual men in a june issue of the mmwr changed health practice at the cdc and around the world. the pandemic of acquired immunodeficiency syndrome (aids) caused by hiv crept slowly into public consciousness, but by the end of the decade, no health problem in the world generated more interest and controversy. the cdc was at the center of both. during those years, more than a third of the agency's budget was directed toward researching this illness and the virus that causes it. the agency's budget grew to approximately $ billion by the end of the decade. its constituency grew with the budget, and both domestic and global partnerships expanded considerably. at the cdc, behavioral and social scientists rapidly developed an important niche, and the move of the national center for health statistics in to what was now the centers for disease control brought a wealth of data and enhanced the role of the statistician at the cdc and in public health practice. the last decade of the twentieth century was marked by expansion of programs and budget in the newly defined priority areas at cdc, especially chronic diseases. in , the cdc's name changed to reflect its broadened mission, and it became the centers for disease control and prevention. by , the cdc budget had exceeded $ billion. the chronic disease budget was $ million that year and was dedicated primarily to development of programs for preventing breast and cervical cancer. in addition, routine data collection was being established at the state level through the behavioral risk factor surveillance system, and state-based cancer registries were implemented to provide a data baseline for defining problems and evaluating program effectiveness. emerging infections (e.g., escherichia coli o :h , the hantavirus, and west nile virus) and reemerging infections (e.g., antibiotic and drug resistance for bacteria, tuberculosis, and malaria), together with an increasing number of effective vaccines, underscored the continuing importance of infectious diseases. by the end of the century, ten major programs (then termed centers, institute, and offices) were located at the cdc, the last focusing on unintentional injuries and violence. an th center was created a year later. global health programs related to hiv and other worldwide public health concerns continued to grow. by , a global network of more than field epidemiology training programs modeled on the eis was established. on any give day, the cdc had more than persons stationed internationally on long-term assignments. nationally and globally, the science and services of the cdc were in great demand. the mmwr was available on the internet and in received . million hits. additional notable public health events marked the early years of the twenty-first century -the terrorist attacks on the world trade center and the pentagon (and the downing of a fourth airliner in a field in pennsylvania) and the deliberate anthrax poisonings in . those two major events were followed in by hurricanes katrina and rita occurring in rapid succession. all of these crises had an extraordinary effect on the country and on the cdc. the emergence of a major change in influenza made real the threat of another pandemic, and this also played out markedly at the agency. two important themes emerged from these events. first, the nation and the cdc needed to adapt their approach to public health emergencies. although the traditional approaches worked, improvement was needed. the impact on the public health system was significant and long-lasting. second, the cdc received substantial additional funding, most of which was provided to traditional partners in state and local health departments to strengthen public health system infrastructures and to adapt to new demands. more than staff are now employed at the cdc, and the budget in exceeded $ billion, $ billion of which was shared with state and local governmental partners and with nonprofit organizations. the new era stimulated a major examination of the agency and its future, and in led to a major reorganization that focused both on adaptation and response to crises but also greater collaboration across the major programs. the intent was to focus on major public health goals and not necessarily specific disease or injury programs, except in support of these goals. as with the reorganization two decades earlier, this process will take years to finalize and to assess the impact. beginning with a regional focus on a single parasite, the cdc has become the premier public health agency in the world, and its expertise has expanded in direct correlation with the expanding view of public health needs. the emerging concerns of the new century -genomics, globalization, the built environment, information technology, global warming, emerging infections, violence, and so onwill require not only the traditional disciplines but also new expertise and new global partners, both public and private. what will remain the same at the cdc is the dedication to its mission in global public health and its adherence to the core values of accountability, integrity, and respect. the new century has already proven challenging and exciting, a situation that cdc anticipates eagerly. ohio) and provides epidemiologic assistance to canada during the winnipeg flood -epidemic intelligence service (eis) established -cdc reports first case of bat rabies in united states -cdc establishes polio surveillance unit during national investigation of contaminated vaccine -asian influenza pandemic; venereal disease division (vdd) transferred to cdc -first assistance to southeast asia in response to cholera and smallpox epidemics -permanent facilities open on property adjacent to emory university campus; tuberculosis program transferred to cdc -morbidity and mortality weekly report (mmwr) moves to cdc; cooperative cholesterol standardization program established -foreign quarantine service joins cdc control; smallpox eradicated in west africa -national institute for occupational safety and health moves to cdc -mmwr reports that lead emissions in residential area are a public health threat -first field epidemiology training program established in canada -global smallpox eradication achieved (eradication certified by the world health organization in ) -first outbreak of multidrug-resistant tuberculosis (mississippi) reported -publication of healthy people established measurable public health goals for the united states for -agency for toxic substances and disease registry established; mmwr publishes first report of toxic shock syndrome associated with tampon use -mmwr publishes first report of fatal disease eventually called acquired immunodeficiency syndrome (aids) -cdc reorganized with new centers for infectious diseases cdc established violence epidemiology branch -office on smoking and health moves to cdc -national center for health statistics moves to cdc -national center for chronic disease prevention and health promotion established -phs recommends that all women of childbearing age consume mg of folic acid daily to reduce risk for spina bifida and anencephaly -national center for injury prevention and control established -cdc's prevention mission is recognized, and it becomes the centers for disease control and prevention -polio elimination certified in the americas -cdc reports measurable levels of serum cotinine in blood of % of nonsmokers in united states -cdc participates in presidential apology for the tuskegee study of syphilis treatment among black men -cdc's laboratory response network established -national center for birth defects and developmental disabilities established -director's emergency operations center opened -cdc provides global assistance for surveillance and clinical and laboratory evaluation regarding severe acute respiratory syndrome (sars) cdc's th anniversary: director's perspective cdc's th anniversary: director's perspective cdc's th anniversary: director's perspective cdc's th anniversary: director's perspective cdc's th anniversary: director's perspective-david satcher cdc's th anniversary: director's perspective sentinel for health: a history of the centers for disease control legionnaire's disease: description of an epidemic of pneumonia current cdc efforts to prevent and control human immunodeficiency virus infections and aids in the united states through information and education the cutter incident: poliomyelitis following formaldehyde-inactivated poliovirus vaccination in the united states during the spring of . i: background. ii: relationship of poliomyelitis to cutter vaccine. iii: comparison of the clinical character of vaccinated and contact cases occurring after use of high rate lots of cutter vaccine department of health and human services reflections on the swine flu vaccination program the epidemic intelligence service of the centers for disease control and prevention: years of training and service in applied epidemiology a tribute to alexander d partnerships in international applied epidemiology training and service key: cord- - mv j w authors: zvolensky, michael j.; garey, lorra; rogers, andrew h.; schmidt, norman b.; vujanovic, anka a.; storch, eric a.; buckner, julia d.; paulus, daniel j.; alfano, candice; smits, jasper a.j.; o'cleirigh, conall title: psychological, addictive, and health behavior implications of the covid- pandemic date: - - journal: behav res ther doi: . /j.brat. . sha: doc_id: cord_uid: mv j w • the public health impact of covid- on psychological symptoms and disorders, addiction, and health behavior is substantial and ongoing. • an integrative covid- stress-based model could be used to guide research focused on the stress-related burden of the pandemic. • this work could provide a theoretical and empirical knowledge base for future pandemics. around some of the most clinically important psychological disorders, addictive behaviors, and health behaviors for well-being. in the first section, we describe the covid- implications for mental health focusing on (a) anxiety/stress and mood disturbance, (b) obsessive compulsive symptoms and disorders, and (c) posttraumatic stress. such mental health problems, although certainly not exhaustive of the scope of psychological disorders impacted by covid- , are some of the most common mental health issues in the general population and are frequently comorbid with chronic illness. in the second section, we focus on addictive behaviors, including (d) tobacco (combustible and electronic), (e) alcohol use and misuse, and (e) cannabis. these forms of drug use represent the most prevalent types of substance use and are frequently associated with chronic illness and premature death. in the third section, we spotlight health behavior and chronic illness by discussing the role of (f) sleep health and behavior, (g) chronic illness using the example of hiv/aids as an illustrative model, and (h) physical activity. health behaviors represent vital targets for the mitigation of covid-related disease and may play a key role in psychological adjustment and recovery. in the final section, we highlight sociocultural factors (e.g., race/ethnicity, economic adversity), developmental considerations, and the role of individual difference factors for psychological, addictive, and health behavior and chronic illness. we conclude by offering an integrative covid- stress-based model that could be used to guide research focused on the stress-related burden of the pandemic. fear is an adaptive defense mechanism that is fundamental for survival and involves several psychological and biological processes of preparation for a response to potentially j o u r n a l p r e -p r o o f threatening events. covid- represents a true threat, with many unknowns. if you are infected, there is a chance you could die, regardless of your current age, sex, or health status. as such, fear is a natural and adaptive response to this pandemic. on the other hand, every year tens of thousands die from influenza as well as many other preventable or unexpected causes. this raises the key question regarding the degree to which we should be anxious and fearful of . how much anxiety is reasonable? since even basic knowledge about covid- is undeveloped, it will be difficult to clearly discriminate between normal, adaptive fear responses and less adaptive responses. that said, such an overarching true threat and the concomitant stressors such as social isolation, economic uncertainty and so forth could in fact recalibrate what is considered a normal level of anxiety in the general population. research has demonstrated that trait levels of anxiety have increased in the us in recent decades, though the cause of such increases is unknown (twenge, ) . the covid- pandemic is likely to contribute to these basic levels of trait anxiety, thus creating a "new normal" level of anxiety. if we consider the likely general increase in anxiety and stress in the context of diathesisstress conceptualizations of mental illness, we expect that such a salient and broad reaching stressor to increase the incidence of pathological anxiety. anxiety conditions are already highly prevalent (bandelow & michaelis, ) , and we may see an increased incidence of anxiety psychopathology if the pandemic serves to push vulnerable individuals toward the expression of maladaptive levels of anxiety. moreover, those with preexisting conditions are likely to have their symptoms intensify. one could further speculate that forms of pathological anxiety will increase. first responders and hospital personnel, particularly in affected areas are already showing troubling signs of stress and psychopathology (joob & wiwanitkit, ) . it is highly j o u r n a l p r e -p r o o f likely that we will see increased rates of generalized anxiety and posttraumatic stress related to the pandemic and its sequelae. beyond the somewhat vague notion of covid- acting as a stressor to increase both normal and pathological anxiety, it is interesting to consider the specific mechanisms that play a role in this process. there are several well-established parameters that relate to the genesis and maintenance of anxiety that seem highly relevant to the current situation. these processes include perceptions relating to predictability/certainty and controllability of threat (barlow, ) . coming across a shark while swimming is quite different from viewing the same shark in an aquarium since a potential threat in the wild is far less predictable or controllable than one in an enclosure. historically, epidemics and pandemics were considered divine punishments that were essentially uncontrollable. although medical understanding of pathogens has advanced, globalization now facilitates the spread of pathological agents, which diminishes the degree to which we can control them. similarly, naturally occurring mutations and adaptation of viruses ensure that novel pathogens like covid- will emerge and spread. these conditions leave us in a state of uncertainty, except that we can be certain that covid- and other infectious agents will persist. thus, covid- affects many of the core anxiety generating mechanisms since it leads to a sense of diminished predictability and controllability along with increased uncertainty relating to a true threat. ultimately, the covid- pandemic creates an ideal environment for the onset, maintenance, and exacerbation of anxiety symptoms and syndromes. the dsm- posttraumatic stress disorder (ptsd) criterion a (american psychiatric association [apa] , , p. ) defines trauma as "exposure to actual or threatened death." individuals who are closer to that exposure --providing healthcare to those infected, witnessing j o u r n a l p r e -p r o o f the deleterious and perhaps deadly effects of the virus on patients or loved ones, enduring losses of patients, family, or friends --might experience the crisis as potentially traumatic. people on the frontlines of the pandemic, including healthcare personnel, first responders, grocery store clerks, and other essential workers, encounter the threat of possible exposure to the virus regularly and on an ongoing basis. similarly, incarcerated populations and those who might feel compelled, financially or otherwise, to work in close quarters without adequate personal protective equipment (e.g., factory workers) may be exposed to the covid- virus for extended periods without perceived or actual recourse and suffer negative mental health repercussions as a result. covid- survivors, particularly those who might have struggled through various medical procedures and prolonged hospitalizations, may emerge with unique or shared constellations of mental health reactions from risk to resilience. additional high-risk groups include healthcare professionals or first responders who may have experienced significant moral injuries (jinkerson, ; joannou, besemann, & kriellaars, ; williamson, stevelink, & greenberg, ) as a result of making unfathomable decisions on the job (e.g., providing admission or ventilator access to one patient at the sacrifice of another). yet, in addition to considering direct impacts of the novel covid- virus on our population, it is imperative to understand the secondary potentially traumatic effects of the pandemic on individuals and communities. the combination of prolonged stress, close quarters, and self-isolation guidelines has increased risk of domestic violence, child abuse, and substance use (abramson, ; national institute on drug abuse, ; santhanam, ; taub, ) . indeed, physical and sexual violence may escalate without the regular societal checks provided by employers, schools, and loved ones. furthermore, such violence may stem from and/or intensify more unbridled substance use (carter et al., ) emerging from a context where j o u r n a l p r e -p r o o f uncertainty and unpredictability are high, practical stressors (e.g., unemployment, financial stress, food insecurity) may be difficult to problem-solve, and social supports may be distant. furthermore, in this pandemic, issues of grief and loss are inevitably interwoven with those of potential trauma. spiritual and emotional grief processes to honor and emotionally mourn the losses of loved ones may be interrupted by this pandemic, potentially exacerbating or prolonging grief, traumatic bereavement, or ptsd reactions. to understand the effects of covid- on the mental health of those who experience it as potentially traumatic, we need to recognize first that the impacts of trauma may not be fully determined nor completely recognizable until after the traumatic stressor has concluded. the covid- crisis is going to have a long, yet undetermined course, and thus our ongoing reactions to it are dynamic but indicative of peri-traumatic rather than post-traumatic coping (bell, boden, horwood, & mulder, ; lapid pickman, greene, & gelkopf, ) . based upon decades of research, we can expect the majority of the population, regardless of level of proximity to or interaction with covid- , to demonstrate resilience and to recover psychologically in the aftermath of the pandemic (alisic et al., ; kilpatrick et al., ) . a relative minority, the proportions of which are unknown, may emerge from the crisis with clinical or subclinical ptsd or with exacerbation in pre-existing ptsd symptoms and related mental health conditions (e.g., depression, substance use disorder). women are at heightened risk of ptsd following potentially traumatic events (gaffey et al., ; rattel et al., ) and racial/ethnic minority populations may be especially impacted due to socioeconomic inequities and health-related disparities with regard to financial security and access to healthcare and treatment (asnaani & hall-clark, ; cross et al., ; sibrava et al., ) . the intersections of trauma and the covid- pandemic are complex. many constellations of interweaving risk and protective factors, learning histories, and life circumstances can affect how trauma histories and potentially traumatic experiences during the covid- crisis can affect individual journeys of recovery. for example, more unbalanced, negative individual interpretations of the covid- crisis and related changes in beliefs about oneself, others, or the world may have lasting deleterious effects (e.g., "i am damaged"; "people cannot be trusted"; "the world is dangerous and unsafe"; beierl, böllinghaus, clark, glucksman, & ehlers, ; bernardi & jobson, ; köhler, goebel, & pedersen, ; losavio, dillon, & resick, ; scher, suvak, & resick, ) . similarly, avoidance of thoughts or emotions related to the covid- crisis may increase the risk of developing ptsd symptoms and/or exacerbating or maintaining pre-existing trauma-related symptoms (e.g., orcutt, reffi, & ellis, ) . additional risk factors for the development or exacerbation of ptsd symptoms include a prior history of trauma or mental health disturbances, depressed or anxious mood, significant concurrent life stressors (e.g., financial problems, job loss, relationship stress), low social connectedness or support, sleep disturbance, substance use, and emotional numbing or detachment (colvonen, straus, acheson, & gehrman, ; cusack et al., ; germain, mckeon, & campbell, ; hancock & bryant, ; shalev et al., ; steenkamp et al., ; vujanovic & back, ) . navigating the covid- crisis requires a tolerance of uncertainty that is challenging for all, but especially trauma survivors who may have endured, sometimes over months or years (e.g., combat, childhood abuse), unfathomable circumstances that were, by definition, unpredictable and uncontrollable (e.g., raines, oglesby, walton, true, & franklin, ; vujanovic & zegel, ) . undoubtedly, social connection and a sense of community and collectivism, hope, psychological awareness, and healthy coping will j o u r n a l p r e -p r o o f differentiate risk versus resilience trajectories during and after this crisis (bernardi & jobson, ; long & gallagher, ; thompson, fiorillo, rothbaum, ressler, & michopoulos, ) . learning who suffers long-term negative effects of the covid- pandemic, why, and under what circumstances will help us to understand how to intervene most effectively to psychologically support trauma survivors in the aftermath of this and future societal crises. indeed, reactions of trauma survivors to the covid- crisis are also likely to be as diverse as the traumas and individuals themselves with the possibility of emergent themes. theoretically, individuals with histories of being directly impacted by natural disasters, people recovering from severe medical conditions, and those with histories of imprisonment or captivity may feel especially emotionally reactive to the large community-level impact, the social distancing and quarantining aspects of weathering covid- , and the continual perceived health threat inherent to the pandemic. individuals with interpersonal trauma histories may experience a solidification or exacerbation of maladaptive beliefs relevant to trust, safety, or power. others may feel increased social detachment or engage in increased harmful, self-injurious, or suicidal behaviors, particularly those with mood or substance use disorders. for some trauma survivors, following social distancing and self-quarantine guidelines may lead to less frequent exposure to trauma-related reminders in the outside world and/or a lower perceived interpersonal threat due to social-isolation, but increased trauma-related avoidance during the covid- crisis in turn may exacerbate ptsd symptoms in the long-term. a high-risk subset may emerge who are slow or reluctant to heed public health guidelines due to a reaction against efforts to control, an increased risk-taking propensity, all-or-none thinking, or helplessness resulting from a history punctuated by traumatic, uncontrollable events. this may lead to incessant attempts, by some, to attain perceived control via closely monitoring news, stockpiling food, or supplies, and maintaining constant vigilance. for those affected by trauma prior to and/or during the covid- crisis, the current, chronically stressful global atmosphere where uncertainty reigns may feel especially overwhelming. for others, this crisis may foster growth and resilience as they endure and overcome a crisis of epic and unimaginable proportions. obsessive-compulsive disorder (ocd) is a common ( - % incidence; (nestadt, bienvenu, cai, samuels, & eaton, ; ruscio, stein, chiu, & kessler, ) , disabling mental health condition characterized by presence of obsessions and/or compulsions (american psychiatric association, ; markarian et al., ) . symptoms present in a heterogeneous fashion across a number of dimensions, including contamination/cleaning, taboo obsessions (i.e., sexual, aggressive content), symmetry/repeating/ordering, and checking (mckay et al., ) . childhood onset occurs in over % of cases and symptoms run a chronic course without adequate intervention (pinto, mancebo, eisen, pagano, & rasmussen, ) . clinical presentation is further characterized by frequent comorbidity (stein et al., ) and variable degrees of insight (hamblin, park, wu, & storch, ) . the covid- pandemic is likely to have a number of effects on those with ocd, as well as those at risk. this includes the potential for symptom exacerbation and increased incidence of ocd cases, as well as having implications for assessment and treatment post-covid- . patients with ocd commonly present with contamination obsessions and associated cleaning compulsions (mataix-cols, do rosario-campos, & leckman, ; pinto et al., ) . some individuals with contamination related ocd have reported that their symptoms have worsened in light of public health recommendations for increased cleaning behaviors (e.g., washing, wearing masks) and other safety behaviors (e.g., social distancing, wearing masks), j o u r n a l p r e -p r o o f which may be difficult for some patients to maintain within recommended guidelines. covid- has become a feared outcome for many patients with contamination-related ocd similar to other what has been observed with other infectious diseases (e.g., hiv). outside of contamination-focused symptomology, other obsessive-compulsive symptoms may be affected such as harm obsessions whereby someone fears that they may have unintentionally spread covid- . stress has an established relationship with worsened obsessive-compulsive symptoms (adams et al., ; brander, perez-vigil, larsson, & mataix-cols, ) , and availability of coping strategies is taxed for many; this may further impact ocd symptom presentation as well as comorbidity patterns. although systematic data have not been presented, clinical accounts support symptom worsening for some affected individuals while, on balance, many others have not experienced negative symptomatic change. beyond worsening of symptoms in those with ocd, there is the possibility that there will be increased cases in the near future. this may involve those with subclinical symptoms or other risk factors experiencing onset or worsening of symptoms. the behavioral cycle of ocd/anxiety highlights the role of negative reinforcement in which rituals/avoidance are reinforced by distress reduction and creating a cognitive sense of control (i.e., not getting covid- is due to compulsions; rector, wilde, & richter, ) . in this scenario, a person with or at risk for ocd may engage in rituals/safety behaviors in response to obsessional distress which in turn reduces anxiety and is perceived as reducing the risk. reduction in distress may motivate further safety behaviors which, for some at risk, could begin to exceed recommended guidelines. while ordinary levels of risk have risen requiring increased hygiene, it remains to be seen what happens when risk levels decline. that is, do cleaning behaviors likewise decline or remain at elevated states thereby impacting diagnosis rates? assessment approaches should continue to capture j o u r n a l p r e -p r o o f obsessive-compulsive symptoms that are impairing, distressing and excessive relative to current risk levels and not count symptoms that reflect behaviors consistent with accepted public health standards. there are also treatment implications. the gold standard psychological treatment for adult and childhood ocd is cognitive behavioral therapy with exposure and response prevention (erp; mcguire et al., ; olatunji, davis, powers, & smits, ) . this treatment involves gradual exposure to triggers that evoke obsessive-compulsive symptoms while refraining from completing rituals or other avoidance behaviors. a core element to this treatment is that exposure to triggers involves exposure to 'ordinary' levels of risk. covid- understandably has shaken what is perceived as ordinary; fortunately, adept therapists have shifted their practice to utilize exposures that reflect this new normal such as relying on imaginal exposures or exposures targeting rituals in excess of public health agency recommendations. at the same time, some clinicians have negative attitudes towards exposure (meyer, farrell, kemp, blakey, & deacon, ) which is related to reduced practice of this core therapeutic technique (farrell, deacon, kemp, dixon, & sy, ) . it will be critical to provide guidelines established by expert erp clinicians for how providers integrate realistic covid- concerns into their ongoing practice, as well as that in the future. a concerning possibility is that erp treatment post-covid- is diluted by virtue of therapists not practicing exposures to the actual level of risk. cigarette smoking remains the leading cause of preventable death and disability globally. smoking may confer worse covid- outcomes given extensive evidence for the negative impact of smoking on lung health and respiratory function (tonnesen, marott, nordestgaard, j o u r n a l p r e -p r o o f bojesen, & lange, ). indeed, emerging evidence has identified smoking as a possible risk factor for adverse covid- prognosis and disease progression (patanavanich & glantz, ; vardavas & nikitara, ) . in the largest study of covid- patients, . % of severely affected patience were current smokers relative to . % of non-severe patients (guan et al., ). an inverse pattern emerged with non-smokers such that a greater proportion of nonsevere patients identified as a non-smoker relative to severe patients. moreover, . % of covid- patients who either needed mechanical ventilation, were admitted to an intensive care unit, or died from complications related to the disease were current smokers relative to . % of those not experiencing these outcomes. similar disparities in covid- severity across smoking status have been observed in other samples (w. j. zhang et al., ) . thus, these data, albeit preliminary and limited by sample size, indicate that smoking is a risk factor for covid- progression (w. . taking a biological perspective to understand why smokers are more susceptible to severe covid- symptoms, recent research has proposed that smoking and covid- susceptibility and symptom severity may be related to an upregulation of the angiotensin-converting enzyme- (ace ) receptor (brake et al., ) . ace , a membrane-bound aminopeptidase that plays a vital role in cardiovascular and immune systems, is highly expressed in the heart and the lungs (turner, hiscox, & hooper, ; wang, luo, chen, chen, & li, ) . studies have established that ace is a receptor for the covid- virus (j. , and greater ace gene expression has been observed in smokers compared to non-smokers (brake et al., ; cai, ; emami, javanmardi, pirbonyeh, & akbari, ; tian et al., ; wan, shang, graham, baric, & li, ; zhao et al., ; . the upregulation in ace creates an environment that allows greater potential for covid- to j o u r n a l p r e -p r o o f infect human cells among smokers through more opportunity to bind to this receptor (olds & kabbani, ; zuluaga, montoya-giraldo, & buendia, ) . in part, this biological mechanism may help explain observed sex differences in covid- . specifically, covid- symptom severity and mortality rates in china indicate worse outcomes for men than for women, where . % of men and . % of women are current smokers (parascandola & xiao, ; sun et al., ) . it is possible that the elevated smoking rates among men in china, and therefore greater upregulation in ace , contributed to significant gender difference in covid- incidence and severity (j. . in addition to combustible cigarette smoking, there also is growing concern for the impact of electronic cigarette (e-cigarette) use on covid- infection and disease progression (lewis, ) . although it is believed that the worldwide distribution and adoption of ecigarettes has the potential to increase population-level vulnerability to respiratory infecting diseases (olds & kabbani, ) , such as covid- , no studies have assessed e-cigarette use among covid- patients (farsalinos, barbouni, & niaura, ) . given evidence for the impact of various e-cigarette formulations on lung health and functioning (viswam, trotter, burge, & walters, ) as well as the fact that most e-cigarette users are former or current combustible cigarette users (mirbolouk et al., ) , it is possible that product use will critically impact the course of covid- among users. additionally, similar to combustible cigarette use, it has been theorized that e-cigarette use may engage an upregulation in ace that parallels that of combustible cigarette use and increases the likelihood of covid- infection (brake et al., ) . further research on these products and their influence on covid- outcomes is urgently needed. a final point to consider is the effect that the covid- pandemic itself has on smoking. one of the leading reasons for smoking is stress management (baker, piper, mccarthy, majeskie, & fiore, ; garey et al., in press) . the psychological effect of the current global environment, characterized by feelings of fear, uncertainty, isolation, and stress (mertens, gerritsen, salemink, & engelhard, ) , coupled with limited availability of adaptive coping tools due to regulations and consequences of covid- (i.e., social distancing, financial hardship) likely increases the risk for smoking onset, increased intensity, and relapse (patwardhan, ; stubbs et al., ) . smoking initiation and severity, in turn, increase susceptibility for covid- and worse disease-related outcomes. behavioral scientists must engage in targeted efforts to support current smokers and former smokers in achieving and maintaining cessation during this particularly challenging time. there are promising initial findings from smoking cessation programs implemented in smokers managing other infectious disease that may help guide some of these initiatives . as more is learned about covid- , it is imperative that health care providers assess smoking (and e-cigarette) use status as well as relapse potential among former users and provide appropriate education and intervention to help mitigate the potential risk of this health behavior on disease infection and course. the (mis)use of alcohol is a leading risk factor for global disease burden and preventable death (degenhardt et al., ; organization, ) . alarmingly, alcohol use, high-risk drinking, alcohol use disorder (aud), and alcohol-related deaths were increasing before the covid- pandemic (grant et al., ; white, castle, hingson, & powell, ) . despite the widespread belief that moderate alcohol consumption may confer health benefits (diaz et al., ; j o u r n a l p r e -p r o o f et al., ) , more recent work suggests that any alcohol consumption is associated with health risks (griswold et al., ) . in fact, given the immunosuppressing effects of alcohol both generally and in the respiratory system specifically (molina, happel, zhang, kolls, & nelson, ; szabo & mandrekar, ) , it is germane to consider the role that alcohol consumption, whether chronic or in acute response to the ongoing crisis, may have on contraction of the covid- virus. in addition to the direct physiological impact of alcohol consumption on the body, the disinhibiting properties of alcohol (kumar et al., ; oscar-berman & marinković, ) may put individuals at risk for other risky/poor decisions (george, rogers, & duka, ) . for example, those under the influence of alcohol may be more likely to violate social distance protocols, exhibit poor hand washing procedures, or refuse/forget to wear a face covering in public, leading to potential exposure to and/or spreading of the virus. importantly, impulsivity has reciprocal relationships with alcohol such that consumption increases impulsive behaviors and individuals with greater trait impulsivity (mis)use alcohol to a greater extent (dick et al., ) . moreover, the effects of impulsivity on alcohol (mis)use can be amplified by other factors, such as stress, to confer greater risk for alcohol (mis)use (fox, bergquist, gu, & sinha, ) . it is well-documented that stress, both acute and chronic, is a trigger for alcohol (mis)use (becker, lopez, & doremus-fitzwater, ; blaine & sinha, ) . the covid- pandemic has brought about both acute (e.g., work displacement, limited availability of cleaning supplies) and chronic stress (e.g., financial difficulty, isolation) that likely will contribute to alcohol (mis)use for coping. it also is reasonable to expect that alcohol (mis)use will worsen during the crisis in response to the stress and uncertainty. for example, during the - economic recession, although there was a decrease in prevalence of alcohol use overall (i.e., increase in j o u r n a l p r e -p r o o f abstainers), there was an increase in prevalence of binge drinking (bor, basu, coutts, mckee, & stuckler, ) . this suggests that there may be a realignment/concentration of problematic drinking such that a greater segment of those who do consume alcohol may be doing so in a maladaptive or harmful way. although sales to restaurants and events have reduced markedly during the pandemic, sales of online and to-go alcohol have skyrocketed (nielsen, ) . given shelter in place orders and limits on socializing, it is possible that greater amounts of alcohol are being consumed at home/solitarily relative to social contexts. solitary drinking can, in some circumstances, lead to greater alcohol consumption than social drinking (kuendig & kuntsche, ) and is associated with greater alcohol-related consequences overall (christiansen, vik, & jarchow, ) . for many, the covid- pandemic has led to significant social isolation with in-person socializing virtually eliminated and many working from home (if at all). these conditions may also exacerbate a common reason for alcohol-related relapse: boredom (levy, ) . without other adaptive ways to manage stress, socialize, or simply occupy one's mind, it is possible that craving for alcohol may intensify. finally, there are important treatment implications for alcohol (mis)use during covid- . individuals already report numerous barriers to seeking drug/alcohol treatment (mcgovern, xie, segal, siembab, & drake, ) . in the wake of the pandemic additional barriers may arise such as the perception that one's treatment is not a priority during a 'life or death' pandemic or not worth the risk of leaving one's home. alternatively, for those seeking treatment, there may simply not be local resources available or treatment facilities may have waitlists. although the use of telehealth services are growing in general (dorsey & topol, ) , there is more work to be done, with specific considerations for low-income individuals (e.g. recently unemployed) who j o u r n a l p r e -p r o o f may be reluctant to spend money on treatment, perceive treatment to be a luxury, or not have technological resources or a private location to engage in telehealth. affordable computer-based treatments without the need for a provider that focus on stress and alcohol use (paulus, gallagher, neighbors, & zvolensky, ) could be particularly pertinent during this pandemic. administration center for behavioral health statistics and quality, ) presumably due at least in part to legalization of recreational and/or medical marijuana at the state level (johnston, o'malley, miech, bachman, & schulenberg, ) . notably, cannabis users report using more cannabis during times of heightened distress following national disasters such as the september , terrorist attacks, a pattern that was especially prominent among individuals who experienced post-traumatic stress disorder and depression (vlahov et al., ) . it therefore follows that cannabis use and associated problems may increase during the covid- pandemic. cannabis use increases during times of distress to manage negative affect. in support of this contention, cannabis users report relaxation and tension relief as one of the most common reasons for use (copeland, swift, & rees, ; hathaway, ; reilly, didcott, swift, & hall, j o u r n a l p r e -p r o o f ). data from experimental studies support these self-reports. to illustrate, current cannabis users were randomly assigned to an anxiety-induction or non-anxious control condition and cannabis craving increased from before to during the task among participants in the anxiety condition, but not among those in the control condition (buckner, ecker, & vinci, ) . these data indicate that cannabis users were especially vulnerable to wanting to use cannabis during an anxiety-provoking situation, which has direct implications for the covid- pandemic characterized by heightened stress. notably, this effect was specific to cannabis craving and was not observed for craving for alcohol or cigarettes in this sample of cannabis users. coping motives are the most common reasons cited for wanting to use during laboratory-induced anxiety (buckner, zvolensky, ecker, & jeffries, ) . prospective data collected via ecological momentary assessment also confirm that anxiety is positively, significantly related to cannabis craving at the momentary level, and is related to greater subsequent craving (buckner, crosby, silgado, wonderlich, & schmidt, ) . further, although positive and negative affect were greater immediately prior to cannabis use compared to non-use episode, negative affect increased at a significant rate prior to cannabis use, and decreased at a significant rate following cannabis use; changes in positive affect were not significantly related to use (buckner et al., ) . further, the stress associated with the covid- pandemic may serve as trigger for lapse and/or relapse among individuals undergoing a cannabis quit attempt. in a qualitative interview following cannabis quit attempts, situations involving negative affect and exposure to others smoking cannabis were among the most difficult situations individuals reported in which to abstain (hughes, peters, callas, budney, & livingstone, ) . among cannabis users undoing a self-guided quit attempt, data from ecological momentary analysis indicated that although positive and negative affect were significantly higher during cannabis lapse episodes compared j o u r n a l p r e -p r o o f to non-use episodes, when negative and positive affect were analyzed simultaneously, negative affect, but not positive affect, remained significantly related to lapse (buckner, zvolensky, & ecker, ) . again, the most common reason for use cited during lapse episodes was to cope with negative affect. not only could covid- increase cannabis use, but cannabis use may exacerbate covid- symptoms given that smoking cannabis damages the lungs. respiratory toxins (including carcinogens) in cannabis smoke are similar to that of tobacco smoke but notably the smoking topography for cannabis leads to higher per-puff exposures to inhaled tar and gases (tashkin & roth, ) . further, respiratory symptoms such as chronic cough, sputum, and airway mucosal inflammation are also similar between cannabis smokers and tobacco smokers. the impact on respiratory functioning of cannabis smoke has led for the consideration of cannabis use as a pre-exiting condition that could increase the likelihood of more severe complications should one contract covid- (national institute on drug abuse, ). sleep is a fundamentally restorative process, but it is also highly responsive to stress (irwin, ) . during times of increased stress, sleep, quite paradoxically, serves both as a major line of defense and as a source of heightened vulnerability. these relationships derive from the fact that sleep and immunological functioning are reciprocally related: sleep promotes healthy immune responses and healthy immune responses (e.g., to infectious agents) promote deeper, more restorative sleep (opp, ) . precise mechanisms are of course complex, but several specific links are noteworthy. immune-signaling proteins called cytokines, such as tumor necrosis factor (tnf) and interleukin- (il- ) directly target infection and inflammation but are j o u r n a l p r e -p r o o f also known to promote sleepiness and non-rapid eye movement (nrem) sleep (jewett & krueger, ) . the hormone melatonin, which provides an endogenous marker of circadian phase peaks during the nocturnal sleep period but also has important immunomodulatory effects. conversely, the hypothalamus-pituitary-adrenal (hpa) axis and the sympathetic nervous system (sns), two primary stress response systems, are down-regulated during sleep, decreasing immune-regulating cortisol levels (besedovsky, lange, & born, ) . however, when sleep is inadequate or disrupted, alteration in these systems is readily observable. experimental sleep research provides overwhelming evidence for the detrimental effects of chronic sleep disruption on immune responses including increases in multiple inflammatory markers such as c-reactive protein, diminished immune response to vaccination, and enhanced susceptibility to bacteria and toxins (besedovsky et al., ) . rather than representing enhanced immunity, elevated levels of inflammation are associated with a range of health risks including cardio-pulmonary disease (libby, ) . sleep's inextricable role in human immunological functioning clearly place it at the forefront of critical behaviors during a pandemic. unfortunately, multiple aspects of the covid- pandemic threaten healthy sleep patterns which in turn endanger both physical and mental health. widespread uncertainty, -hour media coverage (including misinformation), fear for one's own health and the health of loved ones, and potential loss of employment/wages are but a few of the significant sources of stress present during these unprecedented times. heighted psychological and physiological arousal elicited by such stress falls in direct odds with a calm, quiescent state necessary for sleep onset and maintenance. further, common behaviors aimed at managing increased stress and anxiety such as smoking, alcohol consumption, and decreased physical activity can give rise to or worsen sleep disruption via known negative effects on sleep j o u r n a l p r e -p r o o f duration and quality (irish, kline, gunn, buysse, & hall, ) . moreover, sleep deprivation can amplify inflammatory responses (bollinger, bollinger, oster, & solbach, ) , increasing the risk for poor outcomes in covid- as unrestrained inflammation is implicated in the pathophysiology of the disease (gamaldo, shaikh, & mcarthur, ) . although predisposing (e.g., genetics) and precipitating (e.g., trauma) factors play a role, stress is considered a primary cause of insomnia (morin, rodrigue, & ivers, ) and among insomniacs, perceived inability to sleep often becomes a major source of stress in its own right. studies that have systematically examined incidence and severity of insomnia symptoms during a global pandemic are unavailable despite ubiquitous anecdotal reports and cautions from health professional regarding the immunosuppressive effects of poor sleep. however, in a recentlypublished study conducted between january and february , , c. zhang et al. ( ) surveyed medical staff responding to the covid- pandemic in china using the insomnia severity index (isi; morin, belleville, bélanger, & ivers, ) . more than a third of workers ( . %) endorsed symptoms indicative of clinical insomnia and those with insomnia reported elevated levels of depression. insomnia is well-known to herald the onset of depression both acutely and years later even among those who have never been depressed (baglioni et al., ) . studies directed at uncovering precise mechanisms of affective risk during the covid- pandemic must therefore consider the presence and severity of insomnia symptoms. the covid- pandemic also has upended daily routines and associated 'cues' that serve to maintain regular sleep schedules. working from home, altered mealtimes, increased sedentary behavior, social distancing, and increased "screen time" are only some of the changes that hold potential to disrupt circadian rhythms that govern sleep-wake patterns. other factors such as social activities also can affect sleep-wake patterns. the human internal circadian clock j o u r n a l p r e -p r o o f runs slightly longer than hours and therefore needs to be 'entrained' to the -hour day via internal and external cues (czeisler et al., ) . sunlight is the most potent exogenous cue that aligns our internal rhythm to the external environment, but quarantine measures and greater time spent indoors means that many individuals are receiving inadequate dosages of light exposure. although public health guidelines center on sufficient sleep duration (watson et al., ) , sleep timing is equally critical for overall health and well-being. misalignment of the sleep period with the body's 'biological night' is routinely linked with a host of serious risks, including anxiety, depression, suicide, cardiac events, and several forms of cancer (baron & reid, ) . healthcare workers who are working long hours and night shifts during the covid- pandemic are therefore a particularly high-risk group for circadian shifts and associated comorbidities. considering sleep's role in immunological function, this represents an area of priority for future research. the intersection of covid- with pre-existing chronic medical illness (e.g., cardiovascular disease, diabetes, hiv) raises additional challenges to the patient for managing multiple treatment cascades. these challenges are exacerbated by the poorer survival and disease course for patients with underlying medical conditions (emami et al., ) which in turn seems to be driving, in part, the alarming covid- racial disparity (laurencin & mcclinton, ) . the overlapping epidemic of covid- with hiv, for example, presents unique challenges for hiv access to care, hiv treatment engagement, and prevention. infection or if it exacerbates the likelihood of poor covid- outcomes. however, people living with hiv may have other comorbidities, such as cardiovascular disease and chronic lung disease, j o u r n a l p r e -p r o o f that increase the risk for a more severe course of covid- illness (guaraldi et al., ; guo et al., ) . there is also a concern that individuals who are immunocompromised, such as those with hiv, may be at greater risk for severe covid- symptoms (cdc, a; duffau et al., ) . in the u.s., most people living with hiv (plwh) are tested, linked to hiv care, well engaged in antiretroviral treatment, and achieve hiv viral suppression thus ensuring their optimal health and protecting the public health by containing onward transmission (cdc, b). however, structural and individual barriers to treatment and prevention create enduring inequalities and significantly increase the risk of infection, reduce access to, and engagement in, hiv care, and compromise participation in hiv biobehavioral prevention among particular risk groups. gay and bisexual men (particularly hispanic and african american men) are most impacted by hiv and account for nearly % of new hiv cases. hiv incidence rates in the u.s. are also significantly higher for those who are homeless or living in poverty (denning & dinenno, ) . with respect to individual barriers to care, plwh are disproportionally affected by traumatic life experiences, anxiety, depression, and substance use (brandt et al., ; nanni, caruso, mitchell, meggiolaro, & grassi, ; c. o'cleirigh, magidson, skeer, mayer, & safren, ) . each of these also have been associated with poorer engagement in hiv care, worse antiretroviral medication adherence, and poorer hiv disease course. their co-occurrence and interaction significantly increases both the risk for hiv infection (mimiaga et al., ) and poorer hiv disease management among those already infected (harkness et al., ; pantalone, valentine, woodward, & o'cleirigh, ) . these mental health barriers to full engagement in hiv care may well be exacerbated by increased levels of covid- specific anxieties and j o u r n a l p r e -p r o o f increases in general health-related anxieties. the requirements of social distancing also may contribute to feelings of isolation and loneliness which may in turn contribute to increased depression or depression-related withdrawal. both anxiety-related avoidance and depressive related withdrawal will likely have negative consequences for self-care generally and for hiv care specifically. these increases in distress will occur at a time when access to behavioral health services is already severely restricted. some plwh who become co-infected with covid- will already be struggling with hiv disease management (e.g., missed medical appointments, sub-optimal medication adherence) and may require additional supports to manage care and treatment at a time when many routine supports may not be available due social distancing and lack of routine medical services. protecting access to care and treatment among those already struggling with the complexities of the hiv care cascade who must now manage the additional burdens of the covid- illness is a robust clinical concern. here, we underline the importance of community (carrico et al., ) and health worker based approaches (operario, king, & gamarel, ) to hiv treatment and protecting access to care through innovative and virtual care models. many of those at risk for being lost to care during this covid- pandemic also may be vulnerable to perceived stigma (krier, bozich, pompa, & friedman, ; logie, ). many will have multiple stigmatized identities with respect to hiv status, covid- status, substance use, sexual or gender minority status, and others. keeping our community members and peers involved in our service delivery will help ensure our treatments are delivered in stigma-free contexts. empirical support for integrated treatment platforms that address mental health (ironson et al., ; safren, o'cleirigh, skeer, elsesser, & mayer, ) and substance use issues (mimiaga et al., ; safren et al., ) to protect engagement in hiv treatment and j o u r n a l p r e -p r o o f prevention (mayer et al., ; conall o'cleirigh et al., ) are available to guide these initiatives. in addition, protecting access and supporting engagement (virtual or otherwise), to mental health and substance use treatment will be critically important. these approaches may be particularly key for protecting access to hiv prevention services (i.e., hiv testing, access to preexposure prophylaxis [prep]) for those at risk for hiv. access to these services may be particularly important for those whose behavioral risk profiles and risk appraisals may be disturbed because of the impact of social distancing on usual patterns of substance use or sexual behavior. although much remains unknown about covid- and the mental health consequences of the pandemic, it is likely that regular physical activity offers protective effects. regular physical activity reduces risk of and helps manage conditions that appear to increase risk of adverse outcomes of covid- (e.g., obesity, cardiovascular disease, diabetes; lee et al., ) , and improves immune function (nieman & wentz, ) which likely positively affects the progression of covid- . it also buffers the effect of stressors and (in part thereby) can prevent the onset of mental health conditions (harvey et al., ; jacquart et al., ) . further, diminished physical activity can disrupt sleep quality (buman & king, ; youngstedt & kline, ) , which increases susceptibility to infection and mental and physical illness (see sleep section). hence, establishing or maintaining a regular physical activity habit has the potential to mitigate the impact of the pandemic both at a personal and societal level. establishing and maintaining a regular physical activity habit has proven to be challenging. indeed, only % of adults meet the guidelines set forth by the department of health and human services (whitfield et al., ) . the covid- pandemic has impacted j o u r n a l p r e -p r o o f several factors, including a change in the daily routine and increased stress and anxiety, that can affect the intent of or ability to engage in behavior change. it is important to acknowledge the relationship between factors such as stress or changes in routine and physical activity participation can vary in strength or direction (i.e., negative or positive) depending on the individual and their context. for example, for some routine changes have created barriers for exercise participation, while for others changes to the daily structure have opened opportunities to engage in regular exercise. similarly, stress and anxiety at the "right" level can be motivating for some make exercise part of their daily routine, but when stress and anxiety become overwhelming, automated emotion action tendencies often cause people to move away from healthy (coping) behaviors such as exercise (otto et al., ) . importantly, such relationships may further vary within and across individuals depending on other individual difference variables (e.g., risk factors, protective factors, [mental] health diagnosis) and contextual factors (e.g., job loss, financial stress, isolation). research aimed at understanding the relationship between covid- and physical activity mostly likely will benefit from considering the importance of individual differences and the influence of contextual factors. comprehensive assessment batteries and statistical models that include the testing of these complex moderation effects are key. this perspective that acknowledges nuance in the relationship between covid- (pandemic) and physical activity also will aid efforts to develop or fine-tune intervention programs for physical activity uptake. the covid- pandemic, although still ongoing and presently under investigated from a behavioral health perspective, is apt to impart acute and potentially chronic exacerbations in psychological symptoms and disorders, addictive behavior, and health behavior and chronic j o u r n a l p r e -p r o o f illness. across various phenotypes overviewed in the current essay, previous scientific work and theoretical models predict covid- , regardless of acquisition of the virus, has and will continue to have a strong negative psychological impact on negative mood states, various forms of substance use, and sleep, chronic illness, and physical activity. although many of these relations would be expected, theoretically, to be negative, select subgroups will certainly adaptively respond to covid- related stress (e.g., improve their physical fitness, improve self-care routines, quit/reduce maladaptive behaviors that place them at risk). in this final section of the paper, we discuss sociocultural considerations, developmental issues, and the role of individual difference factors for covid- -related psychological, addictive, health behavior and chronic illness. we conclude by offering an integrative covid- model that could be used to guide research focused on the stress-related burden of the pandemic. certain subpopulations and contextual factors (e.g., loss of work) are likely to signify a vulnerability gradient for covid- in terms of mental health, addictive behavior, and health behavior. although there are numerous possible sociocultural factors that could be relevant, we highlight first responders and medical professionals, economic adversity, and racial/ethnic factors as three prototypical factors of public health importance. of all the sectors of the population, first responders and front-line healthcare professionals are arguably at the greatest risk for at least acute disruptions in anxiety, stress, and negative mood. first responders and healthcare professionals at the front line of the covid- pandemic have at their core mission to protect and preserve life (prati & pietrantoni, ) . these groups, although engaging in a diverse range of specific occupational activities (e.g., direct medical care, transport, public safety j o u r n a l p r e -p r o o f enforcement), share in common that they are among the first to respond to the covid- crisis and take primary responsibility for attending to covid- related health issues. first responders and healthcare professionals are undoubtedly experiencing emotionally challenging and unpredictable situations that can place their lives in danger. the acute emotional effects of managing covid- cases is likely to be amplified by heavy work schedules and reduced access to and isolation from social support systems (e.g., self-isolation after finishing a shift). it is likely that first responders and healthcare professionals working with covid- cases in hospitals will be exposed to potentially traumatic events, the greater-than-usual experience of life-threatening situations, working with emotional strain related to isolation of patients from their families (e.g., compassion stress in the form of offering emotional support to patients in a manner that family or caregiver of patients would typically offer), and exposure to the struggle to life and death. these experiences are apt to challenge the coping resources of even the most seasoned professionals, which can result in higher degrees of anxiety, stress, and depressed mood (lafauci schutt & marotta, ) . such elevated stress levels are likely to be related to changes in cognition and physical health, including emotional exhaustion, fatigue, sleep dysfunction, and problems with interpersonal relationships (kronenberg et al., ; lane, lating, lowry, & martino, ) . cognitive-based beliefs about personal safety and health can be altered and memories of potentially traumatic events engrained (setti & argentero, ) . collectively, the covid- related stress burden, as discussed in several sections of the current essay, will have a high likelihood of being related to increased risk of anxiety and depression for first responders and medical professionals working at the front line. moreover, consistent with past literature of these populations, the regulation of affect will be associated with addictive and health behavior to modulate such affect (e.g., physical activity, substance j o u r n a l p r e -p r o o f use). although some regulatory behavior will be adaptive (e.g., increasing sleep where possible to aid in recovery, engaging in regular physical exercise), others may be less adaptive (e.g., smoking to reduce stress) and promote the risk for other health problems (e.g., physical illness). economic adversity. economic hardship related to covid- is already evident at numerous levels of analysis, including job loss, reduced earnings, higher debt relative to assets ratio, inability to pay mortgage and bills, meeting governmental guidelines for poverty status, and worry about financials resources going forward due to the turbulent nature of the economy. past work has shown that economic hardship is related to behavioral health problems, including psychological disorders, addictive behavior, physical health problems, and interpersonal dysfunction in adults and children (k. j. conger et al., ; sareen, afifi, mcmillan, & asmundson, ) . for instance, economic adversity has been linked to reduced social competence and elevated physiological markers of stress (k. e. bolger, patterson, thompson, & kupersmidt, ; evans & english, ) . further, economic hardship is related to selfregulation capacity and the corresponding difficulty in dealing with additional responsibilities. for example, past work has found limited socioeconomic resources are related to harsher parenting behavior and greater substance use (r. d. conger & donnellan, ) . the negative effects may be particularly profound when economic hardship is severe or chronic (dearing, mccartney, & taylor, ; magnuson & duncan, ) . the totality of worsening economic conditions for individuals and families in the larger context of an uncertain economic future are apt to be related to elevations in anxiety, stress, and depression as well as other negative emotional states (e.g., anger, frustration, fatigue; newland, crnic, cox, & mills-koonce, ) . such emotional symptoms and problems are likely to be related to elevations in substance use and other maladaptive behavior (e.g., less supportive interpersonal behavior, less affection) and j o u r n a l p r e -p r o o f may exacerbate chronic health conditions. other work has found that these processes also disrupt social interconnections (scaramella, sohr-preston, callahan, & mirabile, ) . primary care givers who have children home from school, are unlikely to be able to work at their full capacity even with added flexibility in schedules. although certain occupations have decreased activity, many have not. therefore, it could be expected that for individuals with added responsibilities of educating their children at home occupational stress may be greater compared to those without such responsibilities. further, it is possible that the accumulation of occupational responsibilities that are not addressed for persons with additional educational responsibilities will accumulate and make it more challenging to recover when going back to 'normal,' resulting in a greater degree of occupational stress. grappling with lower socioeconomic states related to covid- will, for certain segments of the population, offer an additional psychological challenge. indeed, past work has repeatedly documented that lower socioeconomic status is related to adverse health outcomes for chronic illness and mortality rates (adler et al., ; adler, boyce, chesney, folkman, & syme, ) . moreover, harms faced by people who cannot afford not to work in dangerous settings can exacerbate the psychological and health risk associated with coid- . further essential workers are more apt to be persons of color (handerson, mccullough, & treuhaft, ) . certain groups will be more likely to recover than others, which past work indicates is related to poorer health outcomes even at higher socioeconomic levels (kraus, borhani, & franti, ) . moreover, research has found that lower socioeconomic persons experience more chronic stress and negative life events (stansfeld, north, white, & marmot, ) . additionally, lower socioeconomic status is related to cognitive biases for threat (chen & matthews, ) , which engender greater degrees of interpersonal conflict and heightened negative emotional states j o u r n a l p r e -p r o o f (matthews et al., ; stansfeld, head, & marmot, ) . it would be expected that such negative emotional experiences will be related to maintained direct relations with poorer health behavior and health outcomes (mcewen & stellar, ) . in fact, research has consistently found that lower socioeconomic status is related to greater degrees of anxiety, stress, and depression when compared to those higher in socioeconomic status (mcleod & kessler, ) . this heightened stress reactivity may be at least in part attributable to having fewer resources. consequently, those struggling with a lower socioeconomic status due to covd- may be more contexts in which they must utilize their emotional resources and be less likely to be in a sociocultural context wherein such resources can be replenished (holahan, moos, holahan, & cronkite, ) . this perspective is in line with past work that has found that when persons are exposed to chronic stress, emotional resources are challenged, and there is a greater risk for future emotional distress (n. bolger & zuckerman, ; ensel & lin, ) . there is broad band evidence that significant health disparities exist for persons of racial/ethnic minority in the u.s. and beyond prior to covid- for psychological, addictive behavior, and health behavior as well as chronic illness. for example, african american/black individuals experience a disproportionate burden in disease morbidity, mortality, disability, and injury (mechanic, ; mensah, mokdad, ford, greenlund, & croft, ) . indeed, african american/black individuals remain significantly and consistently more at risk for early death than do similar non-latinx white individuals (williams, neighbors, & jackson, ; williams, yu, jackson, & anderson, ) ; overall early death rates of african american/black individuals are comparable to those observed among non-latinx whites in the u.s. decades ago (levine et al., ; williams & jackson, ) . differences in prevalence and rate of growth of chronic illness are not accounted for solely by j o u r n a l p r e -p r o o f exposure to lower income environments (franks, muennig, lubetkin, & jia, ) . indeed, social determinants of health (e.g., racism; krieger & sidney, ) , addictive behavior (e.g., tobacco use; sakuma et al., ) , and stress represent robust and consistent factors related to health inequalities among african american/black individuals and those from other underrepresented racial/ethnic groups. the covid- pandemic has appeared to strike racial and ethnic minority populations (e.g., african american/black) hard and with possible longerterm consequences. for example, less access to health care services for chronic illness, addictive behavior, and mental illness could exacerbate covid- related symptoms or promote a greater degree of stress-related burden associated with the pandemic (e.g., worry that loved ones, if infected, cannot access care). consequently, addictive behaviors (e.g., smoking, alcohol misuse) and health behaviors (e.g., disrupted sleep, emotional eating) may be used in the short-term to cope with such covid- related stress, increasing the longer-term risk for more severe negative emotional symptoms and health complaints (e.g., pain) and chronic health problems (e.g., obesity). additionally, situations characterized by mass fear and confusion, such as the current pandemic, also can elicit a human instinct to resolve the confusion and mitigate the fear by identifying a culprit for the introduction or spread of the disease (bard, verger, & hubert, ; bromet, ) . asian american persons are one group that has been singled out as responsible for the covid- . the misdirection of fear and/or anger related to covid- toward a racial or ethnic group instead of the disease, however, can perpetuate fear and contribute to racism and stigma. several reports have already documented the rise in violent crimes and discrimination experienced by asian american persons related to covid- beliefs (e. liu, ) . covid- specific language, such as referring to covid- as 'the chinese virus,' has created a platform j o u r n a l p r e -p r o o f to propagate stigma and discrimination towards asian americans. it is likely that stigma and discrimination experienced by asian americans in response to covid- will increase emotional distress, coping-oriented addictive behavior, and may alter health behavior or exacerbate chronic illness. it would also be remiss to not call explicit attention to the fact that societies marked by greater economic and social inequality experience far more medical, psychological, and social pathology than do societies where such wealth inequalities are less pronounced (wilkinson & pickett, . further, such adverse effects occur across social classes, not merely among the most disadvantaged. yet, the adverse effects of economic (and thus social) inequality hurt everyone, although the poorest or most marginalized are affected the most (pickett, kelly, brunner, lobstein, & wilkinson, ; wilkinson & pickett, ) . there are far-reaching implications for psychological health, addictive behavior, and health behavior from a developmental perspective. for children, despite covid- appearing to have less severe symptoms and lower mortality rates than other age groups, are among the highest risk groups (sinha et al., ; zimmermann & curtis, ) . estimates suggests that there are over billion children not in school (cluver et al., ) . the economic impact of covid- will likely be related to greater risk for children to be utilized to offset such financial hardship (e.g., selling merchandise on the street, forced begging for food and goods) and be a more likely to be abused (campbell, ) . for example, it is possible that children will be more likely to be used for child labor and be exploited for sexual behavioral and experience corresponding risk for sexual disease and pregnancy as well as serious psychological distress. interpersonal violence and child abuse will affect children at a significant rate, especially under j o u r n a l p r e -p r o o f conditions wherein there is no oversight from educational systems due to quarantine. world health organizations are already predicting an increase in children who will be orphaned and exposed to abuse and neglect (cluver et al., ) . child abuse is less likely to be detected during the covid- pandemic because the reduction or lack of child protection agencies monitoring cases, and teachers less able to detect signs of abuse. further, children who received meals at school through government programs such as the national school lunch program may now no longer have access to nutritious food, which can negatively impact their development. the lack of structure from schooling and missed education will have a lasting impact on well-being and apt to be related to increased anxiety, depression, and stress about educational attainment and progress going forward (van lancker & parolin, ) . although on-line school may help offset some of these challenges, disparities will exist for those who are most vulnerable, including those who lack internet access or cannot afford technology. older children and young adults may be more likely to drop out of school to help offset family needs. children and youth also may be engaging in more on-line behavior in general or due to emotional distress (e.g., loneliness due to social isolation) and be increasing the chance for solicitation from others who prey on their emotional vulnerabilities (peterman et al., ) . lacking access to physical activity due to quarantine protocols may reduce fitness levels and immunological response as well as decrease psychological wellbeing (rundle, park, herbstman, kinsey, & wang, ) . children and youth in juvenile systems, such as orphanages, already were exposed to high density living conditions and often lack access to proper medical or psychological care. the covid- pandemic is likely to place pressure on such systems (e.g., more children) and the physical environments of these settings may be amenable to the spread of infection. likewise, refugee or otherwise displaced children and youth often live-in high-density environments j o u r n a l p r e -p r o o f wherein social distancing is challenging if not impossible. further, lack of access in these settings to cleaning supplies and water can catalyze the spread of covid- or even the basic fear of acquiring the virus. to the extent the covid- challenges the medical system, it is possible other forms of medical care necessary for child welfare (e.g., routine exams, immunizations) will be reduced, as was the case during other pandemics such as ebola (mupere, kaducu, & yoti, ) . collectively, covid- places an enormous stress on children and youth, placing them at an increased risk for psychological disturbances and physical health vulnerability (j. j. liu, bao, huang, shi, & lu, ) . covid- also will affect ranges of the lifespan, including adults and older adults. the well-publicized health risks for older adults place an obvious psychological and health pressure on this group. older adults are among the most likely to have a chronic illness (e.g., diabetes, cancer, cardiovascular disease) and consequently they maintain an increased vulnerability to deteriorating health and death from covid- . however, even in the absence of exposure to the virus, the fear and worry about contracting the disease is apt to be significant for this group, especially when in homecare facilities such as nursing homes or hospitals (armitage & nellums, ) . this group also is at significant risk for lacking transportation for food, which could challenge the quality of nutrition and have a negative effect in immunological function. similarly, older adults are among the least physical active groups, which again, will have the potential for decreasing psychological wellbeing and immunity. although not specific to older adults, the potential for disruption in grief and loss of others also is a significant psychological stressor. during the pandemic, regular methods of grieving such as funerals have been limited if not all together impossible. the inability to grieve with others or as traditionally done may spur escalation in psychological distress (e.g., sadness, j o u r n a l p r e -p r o o f depression) and complicate the grief process (wallace, wladkowski, gibson, & white, ) . to the extent that grief is impaired, individuals may engage in maladaptive addictive behaviors (e.g., alcohol misuse) to cope with the aversive experiences. similar types of emotional reactions may occur when parents are separated from their children due to quarantine protocols and disruptions in travel (e.g., cannot travel to see children located in another region). there are several individual difference factors at a psychological level of analysis that will place people at an increased or decreased risk for psychological problems, addiction, and poor health behavior, and chronic illness during and after the pandemic. research over the past few decades has theorized and found consistent empirical support for emotional symptoms and disorders as well as addictive behavior being explained by individual differences in transdiagnostic processes (sauer-zavala et al., ) . transdiagnostic factors may contribute to onset, maintenance, and exacerbation of emotional symptomatology and addictive and health behavior. a core aspect of transdiagnostic models is that they seek to identify basic processes underlying multiple, usually comorbid, psychopathologies or addictive behavior. one set of transdiagnostic factors relevant to covid- may be those that are "reactive" vulnerabilities; that is, individual differences that reflect a heightened emotional response to stressful stimuli. such vulnerabilities influence emotion experience by enhancing or diminishing the normative response to emotion stimuli and states, resulting in an excess or deficit, respectively, beyond typical emotional functioning; or altering the type of response to emotion stimuli and states (gratz & roemer, ; reiss, ; zvolensky, bernstein, & vujanovic, ) . in both instances, such reactive processes may be maladaptive because they serve to j o u r n a l p r e -p r o o f reinforce the intensity and frequency of future emotional symptoms. for example, when faced with negative emotion states, individuals with an emotional vulnerability factor that limits their capacity to handle distress may be more apt to execute behaviors that preclude habituation to negative emotion states, which could ultimately increase the intensity of future negative affect and solidify beliefs and learned responses that interfere capacity to adaptively respond to distress. to illustrate, a transdiagnostic factor that may be especially relevant to covid- related stress responsivity, substance use, and physical health is anxiety sensitivity (taylor, ) . anxiety sensitivity is a malleable, cognitive-affective factor reflecting the tendency to respond to interoceptive distress with anxiety (mcnally, ) . anxiety sensitivity is related to, yet distinct from, negative affectivity and trait anxiety (keough, riccardi, timpano, mitchell, & schmidt, ) . anxiety sensitivity has demonstrated racial/ethnic, gender, age, and time invariance (ebesutani, mcleish, luberto, young, & maack, ; farris et al., ; jardin et al., ) . given covid- can produce physical sensations and even when not infected, covid-related stress can elicit a range of interoceptive sensations, persons higher in anxiety sensitivity may be more be emotional reactive to such stimuli and engage in behavior to dampen stress symptoms (e.g., using tobacco, alcohol). for example, persons may interpret the onset of aversive bodily sensations (e.g., runny nose, cough, fever) as intolerable or catastrophic, exacerbating the experience of such interoceptive symptoms. further, interoceptive symptoms might be particularly salient to persons with higher anxiety sensitivity who are prone to health inequalities (e.g., racial/ethnic minorities, persons in financial stress), as they may be more apt to perceive these internal sensations as uncontrollable because resources to regulate symptoms (i.e., adaptive cognitive and behavioral skills) are likely diminished due to chronic stress exposure j o u r n a l p r e -p r o o f (e.g., low socioeconomic status, discrimination). in turn, persons higher in anxiety sensitivity may be motivated to use substances to reduce emotional and interoceptive distress, elevating their chance for physical illness and compromised immune system function. although this illustrative example represents only one of many possible transdiagnostic amplifying factors, it draws attention to the fact that individual differences in psychological processes are apt to play a central role in the relation between covid- related stress and mental health, addictive behavior, health behavior, and chronic illness. individual difference factors also may play roles in offering resilience to covid- related stress. that is, individual differences may contribute to the likelihood of a resilient response to covid- in the short and long term. thus, in addition to the many situational and contextual factors, individual difference factors will likely shape the level of resiliency to covid- pandemic. here, it is likely individual difference factors that de-amplify stress responses will play a central role in offsetting relative risk for psychological, addictive, and health behaviors problems and exacerbation of chronic illness (pidgeon & keye, ) . as with affect amplifying factors, such as anxiety sensitivity, there most certainly is a range of factors of potential importance, including flexible coping repertoires, mindfulness, self-efficacy, selfcompassion, and proneness to experience positive affect. to illustrate, individual difference in the capacity to accept difficult covid- related stress may offset the potential escalation of anxiety, stress, and depression and mitigate the need for addictive or unhealthy behaviors (e.g., emotional eating) to delimit aversive internal experiences (ranzijn & luszcz, ) . consequently, the corresponding risk for health complaints or worsening of chronic health conditions can be offset. indeed, there is a large theoretical and empirical literature that suggests the capacity to accept difficult emotions experiences is related to psychological well-being and j o u r n a l p r e -p r o o f adaptation. for example, one of the reasons meditative practice is related to decreased stress is via change emotional acceptance (teasdale et al., ) . this type of work has robust implications in efforts to intervene on covid- related stress in the immediate context and for those that struggle to regain stability and growth in the future in terms of mental health, addictive behavior, and health behavior. despite the present lack of systematic empirical work on covid- in terms of behavioral health problems, there is good theoretical basis from past scientific work to hypothesize that covid- related stress burden, due to a myriad of sources, may play a major vulnerability role in terms of mental health, addictive disorders, and health behaviors as well as chronic illness. for some, the stress-related burden of covid- may elicit fundamental changes in risk potential and serve as a fertile basis for future behavioral health problems. for others, the ability to adapt to covd- will offer a different course; one that is characterized by greater stability, speed of recovery, and growth. further, it is important to recognize that the adaptation process to covid- related stress is apt to be non-linear in many instances. that is, contextual factors (e.g., future life stressors, access to social support) can influence the degree of risk for future problems. research described in this essay provides a basis to develop a theoretical model that could be used to evaluate covid- related stress burden on psychological, addictive, and health behaviour problems. we therefore begin this section by briefly outlining a general model that can be used as a heuristic for understanding the complex issues at hand. see figure for a graphical depiction of the model. in general, we predict individual differences in affect amplifying and de-amplifying factors will predict the course of psychological, addictive behavior j o u r n a l p r e -p r o o f and health behavior and chronic illness even when considering differences in exposure to covid- experiences (e.g., time of quarantine, acquisition of virus). we would predict, based on past work that transdiagnostic affect amplifying factors will influence addictive and health behaviour, which in turn, will increase (or decrease if de-amplifying) the risk of chronic illness and psychological problems and their comorbidity. further, we can expect that this type of perspective will be moderated by daily stress in the future and access to stress-dampening resources (e.g., social support). accordingly, certain subgroups more prone to greater and more chronic stress, such as first responders and racial/ethnic minorities and orphaned children, may be particularly vulnerable. this conceptual model predicts that the associations which exist between are reciprocal and dynamic. although the model offered here is purposively general and is offered only as a heuristic, it is presumed that there is, in fact, specificity between specific affect amplifying and deamplifying factors, moderators, mediators, and various forms of psychological and chronic illness. that is, a specific type of individual difference factor like anxiety sensitivity is linked to a particular type of problem (e.g., anxiety disorder, worsening of a chronic respiratory illness, severity of hazardous drinking) via a specified mediating process (e.g., smoking, sleep disruption) in the context of certain moderating variables (e.g., higher levels of covid- stress burden). the core idea being that the underlying mechanism in this hypothetical example may be quite different from that explaining other problems. the above theoretical model requires empirical testing, and if it is confirmed, one next logical step would be to intervene in it to reduce the burden of mental health, addictive disorders, poor health behaviours, and chronic health conditions related to covid- stress burden. ideally, this type of intervention approach would target the root of the pathway, including affect j o u r n a l p r e -p r o o f amplifying (i.e., decreasing levels) and de-amplifying (i.e., promoting growth). however, intervention efforts sit in the fact that the healthcare system will continue to shift and adapt to treatment delivery, including the uptake of digital health technologies. digital health, including mobile health (mhealth), telemedicine/telehealth, and health information technology (e.g., mobile phones, wearable sensors), can be used to develop scalable interventions to promote adherence public health guidelines for mitigating the spread of covid- . they also can be combined with greater attention to affect amplifying (i.e., decreasing levels) and de-amplifying (i.e., promoting growth) factors that govern many psychological, addictive, and health behaviour processes. here, there is great opportunity for growth of digital health interventions to offer standalone clinical grade therapeutic tactics and as an adjunct to face-to-face interventions. this type of work can close the gap in access to care and offer evidence-based interventions to large segment of society. for example, digital interventions can be used to combat resistance to public health measures at the level of individuals and institutions with a consideration of individual difference factors that affect emotional and behavioral self-regulation. indeed, the public's response to public health measures is itself a potential risk and protective factor for many of the psychological, addictive, and health behavior problems reviewed in this essay. the public health impact of covid- on psychological symptoms and disorders, addiction, and health behavior is substantial and ongoing. there is a need for financial and social investment in research to better understand how covid- affects the onset, maintenance, and relapse potential for some of the most common, costly, and chronic behavioral health conditions in the general population. further, there is a need for the study of the role of psychological processes, addictive behavior, and health behavior in terms of the onset and maintenance of j o u r n a l p r e -p r o o f covid- infection and stress burden. there most certainly will be a demand for preventative and intervention efforts for managing the impact of covid- among individuals with elevated negative mood symptoms and disorders, addictive behavior, and certain health behaviors (e.g., sleep disorders) and chronic illness. this work is important to offset the current and projected burden to personal, system, and societal entities, and for providing a theoretical and empirical knowledge base for future pandemics. we presented a heuristic model, which posits that covid- related stress and mood, addictive, and health behavior may, in fact, exacerbate each other via several distinct mechanisms. future research in this emerging area has the potential to refine both theory and application with respect to covid- and its relation to affect, addiction, and health behavior as well as chronic disease. j o u r n a l p r e 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prevention options in children. the pediatric infectious disease journal are the high smoking rates related to covid- outbreaks? distress tolerance: theory, research, and clinical applications we wish to draw the attention of the editor to the following facts which may be considered as potential conflicts of interest and to significant financial contributions to this work zvolensky receives personal fees from elsevier, guilford press, and is supported by grants from nih he receives research support from nih, texas higher education coordinating board, rebuild texas and greater houston community fund. he receives travel support and honorarium from iocdf for training in ocd treatment schmidt is supported by the military suicide research consortium (msrc), department of defense, and visn mental illness research, education, and clinical center buckner receives funding from the u.s. department of health & human services' graduate psychology education (gpe) program (grant d hp ) smits reports grants from cancer prevention and research institute of texas; personal fees from big health, ltd., personal fees from aptinyx, inc., personal fees from elsevier vujanovic receives book royalties from routledge press and is supported, in part cleirigh is supported by grants from the nih and the centers for disease control and prevention we confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed he/she is responsible for communicating with the other authors about progress, submissions of revisions and final approval of proofs. we confirm that we have provided a current, correct email address which is accessible by the corresponding author and which has been configured to accept email from mjzvolen@central key: cord- -jr x emx authors: de castro, leonardo; lopez, alexander atrio; hamoy, geohari; alba, kriedge chlare; gundayao, joshua cedric title: a fair allocation approach to the ethics of scarce resources in the context of a pandemic: the need to prioritize the worst‐off in the philippines date: - - journal: dev world bioeth doi: . /dewb. sha: doc_id: cord_uid: jr x emx using a fair allocation approach, this paper identifies and examines important concerns arising from the philippines’ covid‐ response while focusing on difficulties encountered by various sectors in gaining fair access to needed societal resources. the effectiveness of different response measures is anchored on addressing inequities that have permeated philippine society for a long time. since most measures that are in place as part of the covid‐ response are meant to be temporary, these are unable to resolve the inequities that have led to the magnitude of morbidity and mortality associated with the pandemic. these cannot improve the country’s readiness to deal with pandemics and other emergencies in the future. transition to a new normal recognizes the possibility that other infectious diseases could come and endanger our health security. our pandemic experiences are proving that having an egalitarian society will serve the interests not only of disadvantaged sectors but also of everybody else, including the privileged. response measures should thus take the opportunity to promote equity by giving importance to the concerns of the underprivileged and vulnerable while giving preference to initiatives that can be sustained beyond the period of the current pandemic. how dire is the situation in this country compared to the rest of the world? as of august , , the philippines was nd in the list of countries with the highest number of covid- cases throughout the world and it had the highest number of cases among members of the association of southeast asian nations, even though its population is less than half that of second placed indonesia. the philippines also had the highest number of covid- cases per million in the region, and the th highest number of active cases as well as the nd highest total number of deaths in the world. additionally, the country had the highest number of deaths per million population among southeast asian countries as of august , . in light of these statistics, it is quite frustrating that the philippines could only manage to be ranked a lowly th in the number of tests done per million population. perhaps this is partly due to the economic reality that the country's gross domestic product at purchasing power parity (ppp) per capita in was only $ , -rated th worldwide and only th among southeast asian countries. the rankings using the above covid- parameters have deteriorated even after the country was placed under the longest quarantine period in the world. the prolonged lockdown is understood to be the reason why filipinos are experiencing a "recession for the first time since the - asian financial crisis". before the pandemic started to show its effects in the country in january , the unemployment rate was recorded at . percent. it quickly rose to . percent in april , meaning that there were . million filipinos in the labor force who were out of a job -a record high for the country. the impact of covid- has been of such magnitude that social, cultural, economic, educational, political, and health institutions have been shaken. the steps taken to address this impact have forced the government to acquire loans since march this year amounting to us$ . billion, a figure that has worried economists because of what it means for the country's debt to gdp ratio. as the government experiments with ways of jumpstarting a process of recovery for the filipino people, we have to be very clear about the nature of the issues that we need to address as we put together initiatives based on a vision of the future that we can widely share. this paper uses a fair allocation approach to identify and analyze ethical concerns arising in the context of the covid- pandemic. fair allocation is taken to refer to "arrangements that allow equal geographic, economic and cultural access to available services for all in equal need of care." the arrangements can be systemic or politically driven; they can be the product of neglect or indifference. the approach shares the view that "all systematic differences in health between different socioeconomic groups within a country can be considered unfair and, therefore, classed as health inequities, [and these]. . . are directly or indirectly generated by social, economic and environmental factors and structurally influenced lifestyles. while highlighting the existing access or lack of access in the context of very closely intertwined social and health indicators, this paper uses equity and equality interchangeably: "in the public health community the phrase social inequalities in health carries the same connotation of health differences that are unfair and unjust. hence, the paper's fair allocation approach examines the covid- related events and response measures on the basis of the principle that the pandemic experiences cannot be seen in isolation as strictly health phenomena: "health equity cannot be concerned only with health, seen in isolation. rather it must come to grips with the larger issue of fairness and justice in social arrangements, including economic allocations . . . . indeed, health equity as a consideration has an enormously wide reach and relevance." this approach considers the impact of how health-related resources have been allocated or distributed and looks at the issues over a period that precedes the onset of the covid- emergency and extends beyond the expected end of the current pandemic. what this avoids is a narrower view that looks at the covid- emergency as a disease-focused phenomenon that started with the transmission of the virus to humans and will end when a medical solution is discovered in the form of a cure for the disease or employment and fair wage, and economic aid. the difficulties often lie in terms of geographic, economic and cultural access. the resources referred to are not readily recognized by non-medical people as having a huge impact on health although they have long been accepted as social determinants of vulnerability to diseases. , it is perhaps for this reason that the lack -or unfair allocation -of pertinent resources has been insufficiently addressed or pushed down the priority order in government decision-making. this paper examines an extensive inventory of reported experiences and explores their consequences and ethical implications as they arise from the inequities. it also investigates the interconnected and overlapping health, educational, and cultural fronts in the development of the pandemic and the impact that these have on existing social and economic inequities. by examining the way that pertinent resources are accessible to different stakeholders, a fair allocation approach highlights how closely the experiences of various socio-economic and political sectors are bound inextricably together. this is very useful because of the nature and character of the pandemic that we are going through. in the context of the covid- pandemic we are forced to accept that the kind of life that each sector of the country's population experiences is a function of the kind of life that every other sector is experiencing. during better times, we manage to live as if we have separate lives whose mutual and interdependent connections we can downplay or entirely overlook. this happens because the interconnection is not easily perceived even when it is comprehensively present. perhaps it is partly because we have been conditioned to accept the inequities as an inescapable part of reality in a resource-challenged country. the pandemic has put the interconnectivity among various sectors under the spotlight through the impact of sars-cov- . by infecting more than million people of various demographics throughout the world, the virus has manifested its ability to penetrate barriers regardless of nationality, age, ethnic origin, or socio-economic circumstances. there is an undeniably real risk of acquiring infection regardless of who we are and what demographic category we belong to. given the ease of transmission of the virus across the global population, no one can be left untouched by the pandemic's consequences. even statistical outliers such as billionaires who can pass the time away in secluded vacation spots have to be dependent on other people who maintain their yachts, produce and prepare their food, look after their psychosocial and medical needs, and provide such other services as they might require during their prolonged period of seclusion. the ability of these people to provide services can easily be affected by the pandemic. this paper proceeds by identifying specific inequities in the philippines and beyond, exploring how these are being experienced in the context of the pandemic, and examining how problems are being addressed through specific measures in the evolving covid- response. each section focuses on an area of inequity and discusses the implications of measures being implemented not only for the short term but also for the post-pandemic period. the paper goes on to anticipate the ethical requirements for the post-pandemic new normal and to make broad recommendations for an ethical framework that ought to govern our transition to the new normal. facilities but also on a more general access to prevention and basic treatment. if we begin to give thought to considerations of ethics and fairness only when we encounter shortages in the filling of prescriptions or the use of hospital facilities then we are likely to be acting merely to limit, or to make up for harm already inflicted on people because of their unmet healthcare needs. our effort to respond justly to people's emergency health care needs may be too late already at that point. but, using timely preventive measures, or simply well-directed dissemination of information, health problems that send people to emergency rooms can be avoided in the first place. these can even be addressed much earlier by attending to social determinants of health. there is nothing new about this observation, but the reiteration is timely because the emergency we are facing makes it easier to focus on basic principles of public healthcare. the effort to promote healthcare fairness, guided by the principle of prioritization of the worst off, has to be planned across various stages leading up to emergencies. steps taken to promote fairness at the time of an emergency can easily be a merely remedial measure that ought to have been preempted by proper allocation initiatives way before the existence of an emergency. this paper discusses the fairness of allocation measures in relation to the dispensing of adequate information, the provision of isolation and quarantine facilities, the availability of healthcare services and providers, and the criteria for triage in the hospital setting. it is important for this paper's approach that healthcare is understood to be a two-way effort that involves people caring and people being cared for. this relationship between the "carer" and the "cared for" involves both parties thinking about the situation and making decisions together. the process stems from the autonomy of human beings or their right to self-determination. patients in healthcare settings, as well as non-patients who are the intended beneficiaries of public health initiatives, simultaneously have the status of being cared for and being "carers." they are carers in the sense of having to be decision-makers insofar as the care that they need and deserve is concerned. by virtue of their being carers, they need to have access to information that may initially be available only to those who are regarded as having the primary role as carers (healthcare professionals and authorities). this means that information understandable to carers also has to be rendered understandable to the cared for. this is important in the context of public health and health promotion where healthcare providers may need reminding that dispensing care and information is an effort that they jointly carry out with the recipients. the pandemic emergency does not necessarily clothe them with authority to perform their tasks with arrogance and disdain for the ignorance and lack of medical sophistication that they may occasionally encounter in the cared for. this also means that the perspective of the cared for has to be understood -and respected -by the carer. in this way, the cared for is afforded an opportunity to exercise self-determination. strictly speaking, the cared for does not shift perspectives. what happens is that the perspective of the cared for is taken into consideration by the healthcare provider because the process of caring, on this account, is being done by the carer on behalf of the cared for. the carer and the cared for are partners in the activity. the relationship between them is not hierarchical but complementary, as healthcare providers or researchers need to be reminded when seeking informed consent from patients or research subjects. in this section of the paper, the neglect of these principles, especially the prioritization of the worst off, in public healthcare decision-making is examined in relation to three problems within the philippines in the context of the covid- pandemic: paternalistic decision-making complicated by false information, failure to be mindful of literacy levels, and failure to account for language and other barriers. the first problem is paternalistic decision-making or deciding without consulting stakeholders. the philippine government has needed to act swiftly to contain the spread of the disease. it has had to enforce quickly crafted rules that could not wait for extended rounds of consultations and confidence building. quite understandably, the existence of a pandemic emergency compels decision-makers and government officials to act unequivocally and resolutely. however, emergencies also tend to trigger a highly paternalistic stance that can have the effect of reducing human beings to mere recipients of information. failing to heed instructions for dealing with the pandemic, people may be shunted aside for being obstacles to the implementation of a necessary emergency response. yet, firm and decisive action is not necessarily incompatible with a compassionate and lawful consideration for the rights of citizens regardless of their level of education and health literacy. emergencies should inspire creativity in finding ways to implement laws and rules decisively without showing disrespect for fellow human beings who may not have the means or opportunity to understand the full import of new laws and rules. the arrogant display of power by authorities under these circumstances reflects a paternalistic stance that can deteriorate into a disregard for the interests of the cared for whom they need to protect in the first place. these paternalistic regulations can pertain to decisions to lock down communities without prior consultation or information dissemination, sending patients home even if they have covid- symptoms without giving prior information about the treatment protocol, etc. for example, persons from an urban poor community in quezon city were arrested for violating rules enforced during the enhanced community quarantine (ecq) that took effect in quezon city in april . those arrested explained that they were given false information about the distribution of goods to people who could not go out because of the lockdown. disappointed that the relief goods did not reach them, they wandered off to an area where distribution of relief goods was supposed to be taking place. the philippine national police rejected their explanation so they were arrested. desperately needing food and cash, and possibly exposed to sars-cov- , they were hauled off to jail and told that they were lawbreakers who could not be set free unless they posted bail. , in the aftermath they must have been more exposed to the infection that authorities should have protected them from. the fact that these people were misled into wandering off because of false information was bad enough. the real situation was made even worse because of the treatment that they got for actions motivated by desperation and ignorance. by acting decisively but with insufficient regard for individual sensitivities, authorities could be missing an important opportunity to process issues of fairness in the allocation of resources in the dispensing of full, accurate, and understandable information about the covid- pandemic. local media have reported situations reflecting a failure to appreciate pertinent information by people who have needed information the most but were probably not engaged in a meaningful conversation that considered their perspectives and vulnerabilities. paternalistic decision-making as illustrated here violates the equality between the carer and the cared for, in the carer (officers) failing to factor into decision-making the specific context of the cared for (those arrested). by not being sensitive to the situation of the economically deprived, the authorities failed to give due consideration to the interests of the worst off. in addition, the authorities may have failed to recognize their own deficiencies in disseminating accurate information in an effective and appropriate manner. com/ / /the-phili ppines-coron avirus-lockd own-is-becom ing-a-crack down/ studies abroad have shown that lower income groups have a harder time comprehending health information. , there is a direct relationship between socioeconomic status and the level of health literacy. this is a reason why a lot of filipinos have failed to grasp the full significance of the existence of the covid- pandemic and the importance of cooperating with measures to control and limit its spread. the failure to account for stakeholders' literacy levels violates the prioritization of the worst off. understanding this specific context should result in the provision of more assistance to those in more need of health and educational services, not in the easy targeting for police apprehension. prioritization of the worst off should also apply to the removal of language barriers, the third decision-making problem addressed in in this section. in the philippines, filipino is the national language, and both filipino and english are the official languages. however, as many as languages are spoken in the country. the oecd mentions in the pisa that: "some % of -year-old students in the philippines speak a language other than the test language (i.e. english) at home most of the time." notable efforts have been made by the university of the philippines (up) to translate english medical terms related to covid- into the filipino language. a up professor, eilene antoinette narvaez, has come up with a compendium of filipino terms regarding covid- , and the university's department of linguistics is connecting community translators with one another across the country. the up college of education has written a dictionary of covid- -related terms in both english and filipino for children, and this dictionary contains links to videos of the filipino sign language of the terms. apart from the language or dialect that is being used, the level and the manner of discourse is also important. viewed as a matter of fair allocation, the dissemination of information has to be seen in these terms. communication that is not carried out at the level of understanding pertinent to its divergent audiences or that is not cognizant of their specific information needs can only serve the interests of a select population and thereby contributes to inequity. this inequity arises especially because these divergent audiences are likely to be among the worst off financially and educationally, and deserve to be prioritized. in this country -as in many others -information infrastructures can be fully developed in affluent areas but not in others; access to interesting and high-quality information can be expensive; and training and equipment for the effective use of pertinent technology may not be equitably available." while the capability of new information and communication technology to level the playing field for all citizens has been much heralded, it may also have the reverse effect of exacerbating existing inequalities if access is not widely distributed and benefits are merely integrated into already existing socioeconomic structures. in addition to translation initiatives, telehealth practice illustrates what can be done to address an otherwise crippling lack of access to vital health-related information. advocates of telehealth have been taking the opportunity to highlight how the practice can help address inequities in access to health information and to healthcare more broadly. even before the onset of the covid- pandemic, they were already promoting the use of digital means to address healthcare issues faced by vulnerable sectors. telehealth has been demonstrated to help close the gaps in healthcare service delivery as a way of ensuring that national health- has certainly accelerated the acceptance of telehealth as a means to improve healthcare. aside from providing healthcare access to remote patients, the practice of telehealth has served to limit physical contact in order to reduce the risk of contracting covid- . physicians who previously disliked the use of technology and preferred face to face consultations are now forced to "see" patients remotely. the tide has started to turn and this appears to have happened also in other countries. multiple studies have shown how telemedicine has enhanced health service delivery. , , even before launching the covid- telemedicine hotline, the doh already launched multiple telehealth initiatives: a non-covid- clinical helpdesk (through hotlines), email, and chat (including a doh internet-based messaging app group that is open to lay people and another group for health care workers). physicians offer free services to decongest hospitals. one news. retrieved july , , from https://www.onene ws.ph/the-doctor-is-online-physi cians-offer-free-servi ces-to-decon gest-hospi tals at pgh. the rxbox is now being developed to have telemetry capability, which means being able to connect with a dashboard at the nurses' station where vital signs can be read. the device therefore allows for remote monitoring that minimizes risks associated with the proximity of healthcare workers to patients with communicable diseases. the installation of rxbox devices at pgh as a response to the covid- pandemic will significantly improve access by people in remote locations to health care and information. , another initiative under the up college of medicine's surgical innovation and biotechnology laboratory (sibol) in cooperation with up diliman's electrical and electronics engineering institute is a "telepresence" device, a computer programmed to automatically answer calls from authorized accounts using available teleconferencing and remote-control applications, minimizing contamination and allowing effortless access even by patients with no technological know-how. like the rxbox, a "telepresence" device allows healthcare workers and patients to communicate with each other without need for face to face contact. this paper notes the use of telehealth devices for healthcare providers to listen to stakeholders and not merely to observe them and implement programs without consultation, as we reiterate the view that caring is a two-way exercise. measures responding to the pandemic have to maintain and enhance the two-way conversation between the carer and the cared for. it has significantly improved the quality of delivery by overcoming geographic barriers, increasing accessibility and efficiency by reducing the need to travel, providing clinical support, offering access through multiple platforms that patients can easily connect with, and ultimately improving patient health outcomes. the current pandemic has hopefully provided an irreversible inertia for the doh and other healthcare authorities and stakeholders to accelerate their preparedness and capability to respond to pandemics and disasters not only in the short term but also in the foreseeable future. this approach can be possible by focusing on removing barriers to inequitable access to healthcare communication and other healthcare resources, an important strategy in support of the prioritization of the worst off. paradoxically, the use of telehealth to address one kind of need highlights a problem of another kind. this has to do with healthcare being essentially an expression of closeness, of solidarity, and of removing physical and emotional barriers to well-being. , , thus, we have seen how family members have bemoaned their inability to be close to their loved ones who are being administered critical (possibly end of life) care. , physical distancing appears to be antithetical to human beings' emotional closeness. , but this is another issue that is beyond the scope of this paper. the physical availability of health care workers is a related concern that the next section deals with. the toll that the covid- pandemic has taken on the country's to keep up with the continuing requirements for hrh, emergency hiring has been going on at a frenetic pace, sometimes to the extent of including interns who still lack the experience that would otherwise have been necessary. as part of covid- measures, the doh issued a call for volunteer doctors and nurses in three state hospitals. in response, almost filipino doctors and nurses volunteered regardless of experience and readiness to address the needs in stations for which they have not been thoroughly prepared. this has also been going on in other countries that are more economically endowed. , , here, we are made to wonder how this could be happening when, for many years, the philippines has, in effect, accepted the responsibility of providing care to patients in other countries by encouraging the migration of its own healthcare professionals. this encouragement can be seen in the country creating bureaucratic institutions and promoting legislation to facilitate labor migration since the s. , the long-standing dilemma was highlighted again recently when public officials themselves debated a proposal to allow filipino healthcare workers to leave for abroad in the midst of the pandemic. , eventually, a decision was reached to allow the departure of those who already had legally binding contractual obligations but to temporarily prevent others from entering into new contracts to work abroad. , more recently, the doh authorized the recruitment of fresh medical graduates to work as deputized physicians without having to pass medical board examinations. clearly, the measures described in this section to address the lack of hrh in the context of the covid- emergency are intended to be in place temporarily. emergency healthcare staff are being recruited to work only during the period of the pandemic under contracts lasting only for months. the ban on deployment of hrh to foreign countries will be lifted as soon as the pandemic subsides. disasters for the next epidemic. we know that we need to allocate societal resources for housing fairly to avoid this. if we do not realize how inequities have aggravated our public healthcare situation in the context of the current pandemic, we will not learn our lesson ever. in order to accommodate the rising number of persons needing isolation and quarantine facilities, the national government has coordinated with local governments and the private sector in converting hotels, sports facilities, school buildings, and churches into temporary quarantine sites. the facilities are meant to accommodate asymptomatic or mildly symptomatic patients who are either homeless or whose dwelling units do not have enough spaces to allow isolation. the temporary facilities may suffice for now, but certainly not for the near future. these facilities will be eventually returned to their original use; a more sustainable and long-term solution must be developed. it is about time we realized that the need for safe and healthy housing for all is a concern not only for the economically challenged but also for every other member of the community. in times of pandemic emergencies, anyone and everyone can be affected by the lack of safe and healthy housing suffered by disadvantaged sectors of society. when people get infected by a highly contagious virus and they have no safe isolation space to which they can withdraw, everybody else can be adversely affected as they radiate beyond their household. in a world of interconnected and interrelated human beings, anyone's virus has the potential to infect everybody else. the need for numerous safe isolation or quarantine facilities brings attention to how easily the sars-cov- virus can spread; one measure for this parameter is the basic reproduction number. the basic reproduction number or basic reproductive number (r ) of a disease indicates the number of people that an initially infected person will transmit the infection to assuming no one yet in the population is immune to the disease. on march , , the who reported a reproductive number of to . . another estimate put covid- 's r at around . based on figures from different regions in china and overseas. to make sense of r , for instance the . figure, one person who has covid- will infect around three people with covid- ; total cases are now four. each of these three newly infected will also infect three more, adding nine new cases to the previous total of four. each of the nine new cases will infect three, and so on. from these numbers, one can make sense of how covid- is said to have exponential growth, seen internationally and in the philippines . with exponential growth, as more people get infected, the faster will be the rate of new infections occurring. this growth rate is opposed to a linear growth rate where the rate of new infections occurring stays the same over time. from this picture, we can understand how quickly an entire population can be infected. as a note of comparison, on march of this year, the who announced covid- 's global mortality rate of . %, more than times higher than that reported for seasonal flu's %. we have seen how quickly seasonal influenza can be passed on from one person to another and these reproductive numbers are up to more than times higher than that for seasonal influenza's . . because if they succumbed to the virus the food chain could break. as such, farmers, fisherfolk, food delivery workers, cashiers, grocery baggers, and customer care staff have been hailed as frontliners and heroes. , , , , indeed, some people who have lived in near complete isolation have become infected even though they have been minimally exposed to such frontliners. as more people get infected, fewer and fewer safe spaces are left. this is a message that we get from the experiences in almost every community, but especially in high-density spaces such as crowded informal settlements, prisons, workplaces, public transport facilities, supermarkets, or even hospitals. hence, we are not merely talking about interconnectivity of humans in an abstract sense that is more closely associated with philosophical discourse on concepts such as human dignity or the sanctity of human life in various contexts. we are referring to the physical interconnectivity that gives rise to concrete disease and deprivation that has affected more people with various kinds of social living conditions. we can easily take this for granted in the absence of a pandemic. but recent events have caused an alarming prevalence of the virus and its effects on society. the interconnectedness of people of varying socio-economic standing as highlighted by the pandemic reinforces the view that inequality needs to be reduced and prioritization of the worst off must be observed in order to achieve the best outcomes. by giving more help to those who are more in need we move in the direction of achieving the best outcomes for more people. the impact of interconnectedness and interdependence has been felt also in relation to the increased demand for hospital facilities. in an archipelagic country composed of regions across more than , islands, healthcare facilities are unevenly distributed. in , around two thirds of hospital beds in the philippines were in one area, the national capital region. the problem of physical as public hospitals become congested, some patients have been forced to consider confinement in private hospitals. but this is a privilege that very few could afford. one patient's bill for a -day stay at a private hospital totaled php million or around usd , , which is about equivalent to a middle-class filipino worker's salary for years. an estimate for a private hospital bill for a moderate covid- case amounts to at least php million or a little under usd , . to address these financial concerns, the philippine health insurance corporation (philhealth) has come out with new policies for at least partial coverage of covid- cases. the problem with philhealth is not everyone is able to use it. in the situation in hospitals is further complicated by issues whose underlying roots are not so easy to explain. a person under investigation for having covid- escaped from a private hospital where he or she was being observed. an overseas filipino worker with covid- symptoms also escaped from a hospital to probably go back to work abroad. another patient who tested positive for the sars-cov- virus escaped by jumping from a hospital window after she was not given permission to go home. expenses or space limitations are possible explanations but the exact reasons why these quarantined patients have tried to escape need to be probed further. of course, the reasons may have to do with things that are not unique to hospitals. for instance, socio-economic conditions characterized by inequity and a lack of safety nets for the worst off may compel patients to ignore their health and avoid long hospitalizations so they can continue to try to make a living for themselves and their families. as earlier noted, the fair allocation of critical care resources is a concern that arises way before the need to prioritize patients arises about these factors helps one decide which treatment alternatives suit one's financial capability. to be able to fully understand these factors, people need to be functionally literate and to have a minimum level of health literacy. as we address these issues during the pandemic, it should be clear to us that these are also long-standing concerns that have been waiting for durable solutions. only durable solutions can help us maintain emergency readiness over the long term. in the meantime, during the covid- pandemic, guaranteeing fair access is necessary. one way for authorities to do this is to uphold fair allocation principles in the various areas taken up so far, as well as in emergency critical care. ethics and covid- distinguishes three levels of scarcity and their corresponding effects on the fair allocation of resources like ventilators: first, with little scarcity, first come, first served may be best for equality; second, with more scarcity, the prioritization of the worst off may be best; and third, "with even greater scarcity, a principle that aims to maximize benefit from the resource may be most justified." of interest in this section is the scarcest level. in extreme situations where there are simply not enough resources to accommodate everyone in need, giving protection to the vulnerable could take a backseat as medical vulnerability, in the sense of having comorbidities, could be seen to indicate futility of critical care that includes ventilatory support. an early study showed that for covid- , the case fatality rate (cfr) was elevated among those with preexisting comorbid conditions such as cardiovascular disease, diabetes, chronic respiratory disease, hypertension, and cancer. another study of laboratory-confirmed cases of covid- showed that "patients with any comorbidity yielded poorer clinical outcomes than those without" and "a greater number of comorbidities also correlated with poorer clinical outcomes." moreover, "persons with underlying chronic illnesses are more likely to contract the virus and become severely ill, . . underlying conditions compared with those without reported underlying conditions ( . % versus . %). research findings such as these resulted in elderly patients being refused ventilatory support in italy. the independent reported that a doctor gave an account of medics being forced to ration care to patients in the wake of the covid- outbreak such that elderly patients were being denied care based on their age and whether they had other conditions or not: "in bologna, we are working with -years-old as our cut off, but between and -years-old we still consider comorbidities." there are similar accounts pertaining to sweden's karolinska institute. , yet, the acceptance of advanced age in itself as an indicator of medical futility has to be conclusively established by evidence. statistical findings of high mortality rates among patients belonging to the highest age groups can merely be reiterative of the high mortality rates among patients with comorbidities --elderly patients have a higher likelihood of having more comorbidities. if we overlook this point, the elderly could be exposed to unfair allocation of resources based simply on their age rather than on their having comorbidities that leave them with poor chances of surviving with the use of critical care devices. as george kuchel asserts, "having multiple chronic diseases and frailty is in many ways as or more important than chronological age" and "an -year-old who is otherwise healthy and not frail might be more resilient in fighting off infection than a -year-old with many chronic conditions." in addition, recent studies have generated optimism about the success of measures to delay or minimize age-related immunological defects. admittedly, age serves as a useful indicator of the presence of comorbidities that the elderly are likely to have. however, the studies about chronological age and immunological developments cited above indicate that statistical correlation should not necessarily be taken to mean causal correlation. for this reason, age by itself should not be regarded as a valid basis for short-term triage decision-making. in the absence of validated empirical proof that a particular age level indicates the medical futility of applying scarce critical care resources, the vulnerability of patients that is associated with advanced age should instead signify a need for them to be given pro- everybody is hoping that solutions will soon emerge that can facilitate quick recovery and help individuals and families resume stable lives. solutions being offered are expected to give rise to a new normal. even when the government decides that the economic consequences are too much to bear for covid- quarantine arrangements to continue, we cannot go back to the state of affairs that had to be suspended because of the emergency. we should now realize that we cannot just revive the suspended state. epidemiologists tell us that the covid- pandemic will be with us far longer than we may have expected. while many studies on possible treatments or vaccines are being rushed, it has been observed that the progression of past influenza pandemics "was not substantially influenced by a vaccination campaign." bill gates has declared a plan to spend billions of dollars to build seven vaccine factories simultaneously while research is still going on in order to hasten the process of development but this extremely expensive initiative is not estimated to bring us closer than months to vaccine implementation. while we are still waiting for a vaccine, we can only count on non-pharmaceutical interventions (npis) to limit sars-cov- transmission. this makes it necessary to continue with physical distancing and isolation measures for at least years. even worse, we are reminded that "our record for developing an entirely new vaccine is at least four years -more time than the public or the economy can tolerate social-distancing orders." we appear to be playing a waiting game where the cards are stacked against us. according to studies, the pandemic is not likely to be under control until to % of the population is immune, which has been estimated to be the threshold for acquiring herd immunity in the case of the current covid- infection. , if so, this outbreak may take to months. but there are even warnings that herd immunity may not work because of uncertainty concerning the duration of individual immunity to sars-cov- and the low seroconversion rates even in huge populations known to be covid- hotspots. for instance, a study of , participants in spain showed that only % developed antibodies. seroconversion rates were all less than % for various subpopulations among , participants in china. these rates mean that a huge percentage of the population remains at risk for infection despite all the damage from the pandemic. relying too much on the emergence of natural herd immunity will possibly just increase this damage. in light of these considerations, there have been many predictions of what we are likely to see in a new normal --wearing a face mask becoming routine, an occasional cough being regarded as a threat, workplaces feeling like hot zones, and public transit being personally dangerous. we can anticipate less travel, disruptions to consumer supply chains, social anxiety, heightened agoraphobia and, overall, greater mistrust in one another. as a corollary to physical distancing, digital interconnection is going to be intensified. we have seen this already in the accelerated shift to phone and internet banking, in the move from dine-in to take-out and delivery modes of restaurant food consumption, in the spike of online shopping activities, and even in the accommodation of online religious worship. in the philippines, religious services have been broadcast through social media while physical attendance in places of worship has been limited to a handful. a similar trend is going to be part of the new normal for many aspects of healthcare. we have seen how telehealth has taken on an increased role in the country. telehealth can play a huge role in the new normal and we should make it happen. realistic estimates of how long it will take before we can have a vaccine, if possible at all, together with real concerns about the possibility that other infectious diseases (or global disasters) could come and endanger global health security, impress upon us that the radical changes in our way of life are going to persist even beyond the development of a covid- vaccine. a new normal has begun to set in. the new normal is a sum total of the things that we can do as a departure from what we could do before the pandemic, the new things that we have to learn to do and the new ways in which we have to do these things, the political and cultural structures that are developing, and in general, the ways in which we will have to live our lives because of the challenges that have confronted us and are likely to continue to confront us. the new normal also refers to the period in which citizens are expected to become accustomed to the emerging state of things. as we transition to the new normal and address the challenges that are coming our way, we have to remember that our ability to overcome the problems confronting us during the pandemic has been premised on the equitable sharing of resources. the efforts being exerted to contain the covid- pandemic in the philippines are being focused on addressing manifestations of underlying inequities -though that is perhaps happening more coincidentally than deliberately, and many efforts have been highly problematic and insufficient as pointed out in this paper. because the insufficient efforts have been triggered by the existence of an emergency, most of the response measures are meant to be temporary. people on the brink of starvation have been receiving emergency food aid, and those with no financial savings have been receiving cash assistance. however, these efforts have neither been fully successful nor sustainable. , , those who could not be isolated or quarantined have been evacuated, but these evacuation facilities are also temporary and the occupants are going to be reinstated in their cramped dwellings that cannot protect them from new transmissions or other communicable diseases in the future. if the inequities continue in the new normal, the normal is not going to be really new. the vulnerable are going to remain vulnerable and philippine society will not be more prepared for the next pandemic. clearly, the lesson is that everyone, especially the most economically disadvantaged, need to have access to the resources that relate to their healthcare, inter alia, -adequate and accurate information so they can be properly advised about their healthcare needs; clean flowing water so they can wash their hands properly; and dwelling units that will give them the capability to be isolated from neighbours or from household members who can be infected. in support of these necessities, they will require employment opportunities that can yield fair wages or other opportunities to generate adequate income, and social and health insurance coverage that they can fall back on in times of need. subject to certain logistical limitations, the philippine government has seen the indispensability of temporarily providing the required resources to disadvantaged sectors. however, a lot more needs to be done. the distribution of resources has to proceed in a way that transcends the long-standing barriers associated with structural social inequities. sustained fair allocation founded on equality, equity, and the prioritization of the worst off is indispensable. sustainability is critical because, as has been pointed out, the problems that need to be addressed are chronic pre-pandemic inequities that are being magnified by the health emergency. there is evidence that the need to improve the plight of the resource challenged has been partially acknowledged by the more economically advantaged sectors of philippine society. small and big business companies in the philippines have made huge contributions to help provide for their emergency needs. the private sector has supported the national government, local government units, and the general population by providing wages to employees who could not work, monetary assistance, relaxed working conditions, emergency transportation, food products, ventilators, test kits, personal protective equipment, and many other goods and services that can help everyone overcome the current crisis. beyond this, these privileged sectors have to realize that what they have helped provide during the emergency is something that needs to be available in the long term and institutionalized for society to survive future pandemics and for their businesses to continue to thrive. institutionalization requires arrangements that would provide realistic opportunities for disadvantaged sectors to acquire the goods and services that they need beyond the period of the current emergency. as we transition to the new normal the most economically deprived should seize the opportunity to establish how important the improvement of their situation is in order for the current widespread problems to be properly addressed. while disadvantaged sectors continue to be dependent on others because of their vulnerability, society should seek to translate the realization that the health and security of the more privileged is dependent on the health and security of everybody else in society into sustainable measures to improve the conditions of the worst off and narrow the gaps between its most endowed and least endowed sectors. in the new normal, there must be institutionalized safety nets that can be accessed when things go wrong. people should not have to beg and fight for places in dignity-sapping queues for the distribution of emergency social amelioration funds --these should be available to them as a matter of right. people should not have to be rushed to temporary isolation and quarantine places -prioritizing the concerns of the worst off is essential for the improvement of everybody's health. to provide them with home spaces that will enable them to care for the sick while still protecting themselves also advances the health interests of everybody else in the country. this reality acquires an unprecedented level of concreteness in the context of a pandemic such as the one that we are currently experiencing. in the new normal, those who require medical attention should be protected by universal healthcare; we ought to realize that "those in the greatest need often have the poorest access to care -a striking example of unfairness." very importantly, people should know all of these, what to do and where to go when they require services because, in the new normal, information will have to be dispensed efficiently and equitably regardless of the people's level of understanding. we see the entirety of the telehealth movement as a paradigm of how response measures ought to be characterized. it uses advanced technology to promote access by the underprivileged to the most important healthcare services. it listens to patients and gives them an opportunity to participate in their own care. what it is trying to do in the course of the current pandemic is something that is only a part of what it should aim to accomplish in the long term. thus, it should be part of a sustained effort that can have a good chance to narrow the gap between the economically privileged and the economically challenged. it exists in sharp contrast with measures meant to address the lack of isolation spaces in many people's dwellings. the isolation and quarantine facilities that have been set up are clearly temporary facilities that cannot be retained beyond the period of the emergency. the people currently using them will be going back to their informal settlements without any prospects of having their living conditions improved. learning from these comparisons, we see the need to observe a number of criteria for evaluating covid- response options consistent with the principles of equality, equity and the prioritization of the worst off: the short-term efforts exerted to contain the pandemic have to be aimed at addressing the inequities. having existed for a long time, these inequities deserve everyone's attention not only during the pandemic but also when we emerge from it. this glaring reality may have been overlooked as authorities focus on the short term and see the measures as a requirement to tide us over until we can go back to normal. thus, addressing the manifestations of the inequities has happened incidentally rather than deliberately, using stop-gap rather than long-term measures. yet, what we are going through now is not merely a fleeting disaster but an instantiation of chronic injustice characterized by inequities on many fronts. the totality of our experiences relating to the pandemic constitutes evidence that the inequitable access to essential goods and services needs to be overcome -not only for the sake of the underprivileged but also for the sake of everybody else regardless of economic, political, or social status. what is being asked of us is not merely to provide for people's needs during an emergency but to manifest our realization that fellow sars-cov- seroprevalence the lancet prevalence of sars-cov- in spain (ene-covid): a nationwide, population-based seroepidemiological study. the lancet seroprevalence of immunoglobulin m and g antibodies against sars-cov- in china three potential futures for covid- : recurring small outbreaks, a monster wave, or a persistent crisis life after covid- : what will change? internet banking trend to continue post-covid. the manila times key: cord- -uy f f o authors: nara, peter l.; nara, deanna; chaudhuri, ray; lin, george; tobin, greg title: perspectives on advancing preventative medicine through vaccinology at the comparative veterinary, human and conservation medicine interface: not missing the opportunities date: - - journal: vaccine doi: . /j.vaccine. . . sha: doc_id: cord_uid: uy f f o abstract vaccination has historically and remains one of the most cost-effective and safest forms of medicine today. along with basic understanding of germ theory and sanitation, vaccination, over the past years, has transformed lives and economies in both rich and poor countries by its direct impact on human and animal life—resulting in the eradication of small pox, huge reductions in the burden of previously common human and animal diseases such as polio, typhoid, measles in human medicine and contagious bovine pleuropneumonia, foot-and-mouth disease, screwworm and hog cholera and the verge of eradicating brucellosis, tuberculosis, and pseudorabies in veterinary medicine. in addition vaccination along with other animal production changes has provided the ability to produce otherwise unaffordable animal protein and animal health worldwide. the landscape however on which vaccinology was discovered and applied over the past years, even in the past years has and is undergoing continuous change. for vaccination as a public health tool to have its greatest impacts in human and veterinary medicine, these great medical sciences will have to come together, policy-relevant science for sustainable conservation in developing and developed countries needs to become the norm and address poverty (including lack of basic health care) in communities affected by conservation, and to consider costs and benefits (perceived or not) affecting the well-being of all stakeholders, from the local to the multinational. the need to return to and/or develop new education-based models for turning the tide from the heavily return-on-investment therapeutic era of the last century into one where the investment into the preventative sciences and medicine lead to sustainable cultural and cost-effective public health and economic changes of the future is never more evident than today. the new complex problems of the new millennium will require new educational models that train para- and professional people for thinking and solving complex inter-related biological, ecological, public-, political/economic problems. the single profession that is best positioned to impact vaccinology is veterinary medicine. it’s melding with human medicine and their role in future comparative and conservation-based programs will be critical to the successful application of vaccines into the st century. vaccination has historically and remains one of the most cost-effective and safest forms of medicine today. along with basic understanding of germ theory and sanitation, vaccination, over the past years, has transformed lives and economies in both rich and poor countries by its direct impact on human and animal life-resulting in the eradication of small pox, huge reductions in the burden of previously common human and animal diseases such as polio, typhoid, measles in human medicine and contagious bovine pleuropneumonia, foot-and-mouth disease, screwworm and hog cholera and the verge of eradicating brucellosis, tuberculosis, and pseudorabies in veterinary medicine. in addition vaccination along with other animal production changes has provided the ability to produce otherwise unaffordable animal protein and animal health worldwide. the landscape however on which vaccinology was discovered and applied over the past years, even in the past years has and is undergoing continuous change. for vaccination as a public health tool to have its greatest impacts in human and veterinary medicine, these great medical sciences will have to come together, policy-relevant science for sustainable conservation in developing and developed countries needs to become the norm and address poverty (including lack of basic health care) in communities affected by conservation, and to consider costs and benefits (perceived or not) affecting the well-being of all stakeholders, from the local to the multinational. the need to return to and/or develop new education-based models for turning the tide from the heavily return-on-investment therapeutic era of the last century into one where the investment into the preventative sciences and medicine lead to sustainable cultural and cost-effective public health and economic changes of the future is never more evident than today. the new complex problems of the new millennium will require new educational models that train para-and professional people for thinking and solving complex inter-related biological, ecological, public-, political/economic problems. the single profession that is best positioned to impact vaccinology is veterinary medicine. it's melding with human medicine and their role in future comparative and conservation-based programs will be critical to the successful application of vaccines into the st century. published by elsevier ltd. the new millennium did not bring the anticipated global internet technology shutdown however, it has brought with and heralded a time of significant change, opportunity and challenges. i and my co-authors goal in this overview are to celebrate, provocate, instigate innovate and activate those in society who are in interested to contributing to the betterment of human and animal health through vaccination. for vaccination to have its greatest chance of working policy-relevant science for sustainable conservation in developing countries needs to address poverty (including lack of basic health care) in communities affected by conservation, and to consider costs and benefits (perceived or not) affecting the wellbeing of all stakeholders, from the local to the multinational. the need to return to and/or develop new education-based models for turning the tide from the heavily return-on-investment therapeutic era of the last century into one where the investment into the pre-ventative sciences and medicine lead to sustainable cultural public health and economic changes of the future is never more evident than today. if the article gets the attention of researchers, educators/teachers, funders, policy makers, economists and the general public in both developed and developing countries to become involved in finding collaborative solutions to the conservation crisis than we will consider it a success. vaccination has and remains one of the most cost-effective and safest forms of medicine toward improving health today. along with basic understanding of germ theory and sanitation, vaccination, over the past years, has transformed lives in both rich and poor countries-resulting in the eradication of smallpox and huge reductions in the burden of previously common diseases such as polio, typhoid and measles. immunization is particularly well suited to all countries including those with weak health systems, because it requires relatively less training and equipment and does not depend on skilled diagnosis, long-term drug regimens or extensive medical care. immunization and sanitation remain as the most important public health modality responsible for improving the gnp of developing countries through additional gains in healthier children who are better educated and grow up to impact on their productivity. like schoolchildren, healthier workers have better attendance rates and are more energetic and mentally robust. workers in healthy communities, moreover, need to take less time off to care for sick relatives. body size, which is greatly influenced by one's health during childhood, has been found to have large impacts on long-term productivity. recent economists [ ] have calculated that a -year increase in life expectancy improves labor productivity by %. despite the weakness of health systems in many developing countries, three-quarters of the world's children now receive a standard package of childhood vaccines through the who/unicef expanded program on immunization to protect them against diphtheria, tetanus, pertussis, polio, measles and neonatal tuberculosis [ ] . these vaccines currently save an estimated million lives a year -almost , lives a day -and protect millions more from illness and permanent disability, thus providing as mentioned above a healthier cohort of people to contribute to the economic development of the nation. the full package of basic vaccines (diphtheria, tetanus, pertussis, polio, measles and neonatal tuberculosis) costs less than $ per year of life saved in poor countries. "life-years" and "year of life" consistently refer to disability-adjusted life-years (dalys). interventions are generally considered extremely costeffective if the cost per year of life is less than $ . by comparison, antiretroviral treatment for hiv/aids-an intervention that donors widely support in the developing world costs up to five times as much at $ to $ per life-year saved; by way of comparison, in the us and the uk medical interventions are considered cost effective at $ , to $ , per life-year saved [ , [ ] [ ] [ ] . the week during the conference in amsterdam it was reported that "vaccine-preventable deaths reach new low in u.s." as reported in a federal report released tuesday, november , people readily associate the role of veterinarians with private veterinary practice focused on pets and farm animals, but the true dimensions and contributions of veterinary medicine are much broader and reflect expanding societal needs and contemporary challenges to animal and human health and to the environment [ ] . veterinary medicine has responsibilities in biomedical research; ecosystem management; public health; food and agricultural systems; and care of companion animals, wildlife, exotic animals, and food animals. the expanding role of veterinarians at cdc reflects an appreciation for this variety of contributions. veterinarians' educational background in basic biomedical and clinical sciences compare with that of physicians. however, unlike their counterparts in human medicine, veterinarians must be familiar with multiple species, and their training emphasizes comparative medicine. veterinarians are competent in preventive medicine, population health, parsitology, zoonoses, and epidemiology, which serve them well for careers in public health. the history and tradition of the profession always have focused on protecting and improving both animal health and human health [ ] . since , a total of diseases have been eliminated from equine, poultry, and livestock populations in the united states [ ] . the elimination of these livestock diseases, along with outstanding research in animal health, is key to the remarkable gains in the efficiency of u.s. animal production [ ] . partly as a consequence, u.s. residents spend only approximately % of their disposable income on food, whereas residents in other countries pay three or four times more [ ] . although this achievement is recognized to have added billions of dollars to other parts of the u.s. economy, its success in allowing the u.s. public access to a nutritious, affordable, and sustainable food supply -also important for the public's health and well-being -is far less appreciated. the success of the national brucellosis and tuberculosis elimination campaigns has benefited not only the u.s. livestock industries but also human health by substantially reducing these zoonotic threats in animals. additional public health contributions can be attributed to the food safety and inspection service of the u.s. department of agriculture (usda), which has substantially reduced the burden of food-borne illnesses, improved food safety, and eliminated other zoonotic threats. over the years, cdc has worked closely with usda and the food and drug administration to improve the safety of u.s. foods and reduce antimicrobial resistance in pathogens that infect both humans and animals. veterinary scientist and veterinarians within the health and human services serve in many critical capacities. veterinary officers in the commissioned corps work throughout the u.s. department of health and human services and in other federal agencies. most veterinary officers are assigned to the cdc, nih, fda, usda, epa, ogha, ndms and state department. other veterinarians and veterinary scientists function as medical research scientists post-doctoral nih/nci fellows, principal investigators, some specializing in lab animal medicine and providing critical lab animal health infrastructure and support, design of animal models for human disease in most of the hhs institutes. some are part of the hhs national disaster medical services and were deployed as the veterinary medical assistant teams (v-mats) and supported the search and rescue in the world trade disaster. additionally, since , the avma and the college of american pathologists have been working together to create a standard nomenclature that would allow veterinarians, physicians, and other medical professionals to create electronic medical records that use a common language. the systematized nomenclature of medicine, snomed, was initially created by the college for human medicine but has sincethrough the partnership with avma -expanded to include veterinary terms. on july , , the department of health and human services announced it would make snomed available nationally at no charge, a step toward instituting a standardized electronic medical records system. the hhs signed a -year, $ . million contract with the college to license snomed and make it available nationally. the national library of medicine is administering the program. prior to the hhs's agreement with the avma, practitioners in areas of practice nationally on the front line of surveillance would have had to pay a $ to $ annual registration fee to access snomed. the cdc has expanded the role, scope, and influence of veterinarians and veterinary scientists and epidemiologists in public health since its inception in [ ] . early in the history of cdc, veterinarians in the u.s. public health service and the cdc veterinary public health division helped reduce zoonotic diseases, especially rabies and food-borne illnesses [ ] . today, veterinarians serve throughout cdc in positions that address not only infectious diseases but also the entire spectrum of public health challenges: environmental health, chronic diseases, human immunodeficiency virus infection and acquired immunodeficiency syndrome, injuries, immunizations, laboratory animal medicine, global health, migration and quarantine, health education, and bioterrorism. veterinarians contribute as epidemiologists, laboratory scientists, policymakers, researchers, and surveillance experts and in environmental and disease prevention and control programs both domestically and globally. at cdc, veterinarians have participated in the epidemic intelligence service since [ ] . forty-one states now have state veterinary public health officials. in , almost students and faculty attended the first veterinary student day at cdc; in april , cdc will co-host an inaugural conference with the association of schools of public health and association of american veterinary medical colleges. in addition, cdc has been recognized as a world association for animal health collaborating center for emerging and re-emerging zoonoses. the cdc publication, emerging infectious diseases, has highlighted zoonotic diseases in nearly every issue to zoonotic diseases and has devoted an annual issue in each of the previous years. the cdc has provided an important scientific forum for zoonotic disease research and programs both domestically and globally and should serve as a template for the nih, as will be discussed later in this paper (section . ), for moving these highly trained and broad-based medical skill set professionals from a more decentralized setting into a central institute at the nih. benjamin franklin's famous quote, "an ounce of prevention is worth a pound of cure" was actually fire-fighting advice-he founded the first fire fighting organization in philadelphia, its obvious application to medicine, although obvious, has not been a mainstay of heavily invested research and development in human health practices. many of the leading causes of death and disability in the united states can be prevented [ ] . primary prevention can prevent or arrest the disease process in its earliest stages by promoting healthier lifestyles or immunizing against infectious disease [ ] . secondary prevention, by detecting and treating asymptomatic risk factors or early asymptomatic disease, can substantially reduce subsequent morbidity or mortality. the human and veterinary clinician plays a pivotal role in both primary and secondary prevention. health professionals deliver vaccinations, screen for modifiable risk factors such as high blood pressure and high cholesterol, counsel patients about smoking and other behavioral risk factors, provide screening tests for early detection of cancer and other chronic conditions, and advise patients about the benefits and risks of preventive therapies such as postmenopausal hormone replacement therapy. the preventative health care landscape has changed in some regards in the years since the u.s. preventive services task force (uspstf/task force) was first established in to provide advice about prevention for health professionals. prevention became more of an integral component of primary health care [ ] . delivery of clinical preventive services such as immunizations, mammograms, and cholesterol screening has risen steadily over the past two decades (national center for health statistics [ ]). roughly % of employers now include well-child visits, childhood immunizations, screening tests, and adult physical examinations among covered health benefits, compared to less than half that did so in [ ] . interest in prevention grew significantly among the public, clinicians, educators, employers, and policymakers [ ] and health plans and individual clinicians were increasingly being held more accountable for the quality of the preventive care they provide to their patients [ ] . at the close of the th century, health care costs in the united states continued to rise steadily, accounting for . % of the gross domestic product in [ ] , and debate on health care funding for the aging american population intensified. no doubt fueled by the incredibly imbalanced historic spending in preventative healthcare of cents for every cents spent for curative treatment [ ] . numbers are harder to come by for recent years, but given the spiraling costs of treatment since it is likely that this ratio has gone down considerably since then-possibly grossly estimated to be closer to : today. in this environment, preventive services often compete with one another and with diagnostic-and treatment-oriented care for increasingly constrained resources [ ] . while preventive services are often believed to save costs, delivery of most preventive services, with few exceptions (e.g. some immunizations), incurs net costs [ ] . evidence that us society clearly favors the cure (or treat) approach to disease over prevention can be shown in the following ways. first, though there is a shortage of preventive medicine specialists (public health, general preventive medicine, occupational medicine, and aerospace medicine physicians), in the us the number of residents in training in was less than . % of all residents, not sufficient for replacement or to fill the expanding demand for the specialty's skills and talents [ , ] . second, preventive medicine residencies and subspecialties in human and veterinary medicine are generally found in only graduate medical education programs not financed by cms or mainstream academic training programs. third, we believe that our preventive acts are only statistical, whereas our curative acts are certain. this mistaken belief perhaps derives from our sense that we have more control over cure outcomes than prevention outcomes-we think that we do cure, whereas we only facilitate prevention. this notion of doing vs. facilitating is an important one, because if we believe that our curative actions are more effective than our preventive ones then we will more likely act toward the more effective. the editor of the british medical journal, fiona godlee, expressed this well when she states, "because it is acted on healthy people, preventive medicine needs even stronger supporting evidence on benefits and harms than therapeutic interventions" [ ] . thus substantial gaps in the delivery of effective preventive care in the united states remained, however, because clinicians continued to face many of the same barriers that originally spurred the formation of the first uspstf. identifying effective interventions were and are difficult in prevention, where prospective controlled trials are often difficult to conduct. these studies come from the field of epidemiology which has changed remarkably during its growth in the past quarter century. one of those changes has been a mixed blessing of ever-increasing specialization among its practitioners at the cost of the generalist. this phenomenon has shaped the field and a partial explanation for this trend is found in the decline in the availability of training funds not focused on specific and general disease areas. without returning to the training of general conservation-medicine based epidemiologists, the needed trend associations and study designs that are needed to show the economic and public health returns related to preventative practices field will not be realized and in addition lose some of its ability to quickly respond to new and expected emerging public health challenges. conflicting recommendations from different organizations, further exacerbated by the advocacy positions of some groups, leave many clinicians uncertain about what to do. clinicians facing increasing time pressures in practice may question the value of some routine preventive interventions, as may employers and other payers struggling with accelerating health care costs. although more prevention information is reaching the public, the messages conveyed are often inconsistent and increasingly colored by commercial self-interest. clinicians may feel compelled to provide unproven or ineffective services because patients demand them or they fear being sued, but patients may find that insurance coverage for individual preventive services, especially new technologies, is inconsistent. the importance of clarifying what we know and do not know about the effectiveness of specific preventive services is as important in as it was in . although the uspstf was disbanded in with the release of the guide, the need to keep pace with the rapid growth in scientific evidence led to convening a second panel in . the second uspstf was smaller, with only members, eight of whom were primary care physicians. it refined the previous group's methods for reviewing evidence and making recommendations, and expanded the scope of topics. it adopted policies for disclosure of conflicts arising from financial interests, funding sources, or other affiliations. the work of the second uspstf was marked by strengthened ties with both federal and nongovernmental partners, including primary care subspecialty societies. the work of the second uspstf culminated in the publication of the second edition of the guide in , which covered over interventions in areas. by the time the second edition of the guide appeared, the environment for preventive medicine and evidence-based medicine had changed dramatically. managed care organizations, which had emerged as a dominant paradigm for delivering and paying for health care, included some preventive care among basic covered services more commonly than had traditional fee-for-service insurance. at the same time, the heightened competition spurred by managed care brought increased attention to costs and value of treatments with less attention given to prevention. the guide was frequently cited by health plans and systems of care in defending their health maintenance programs and benefits packages, and its recommendations informed many of the health plan employer data and information set (hedis) quality measures developed by the national committee on quality assurance for evaluating health plan performance but not integrated into cost saving practices by the insurance companies. the rapid progress towards universal vaccination coverage in the s and s has slowed in recent years. unicef funding for vaccination fell from $ million to $ . million between and [ , ] . global coverage of the diphtheria, tetanus, and pertussis (dtp ) vaccine has been at around % since [ ] . fifty-seven developing countries have yet to eliminate neonatal tetanus, and , babies died of the disease in . ten developing countries reported cases of polio in june , despite the massive (and largely successful) global effort to eradicate the virus [ , , ] . sixty-two percent of countries, meanwhile, had still not achieved full routine immunization coverage in , with gavi estimating that at least . million additional infants need to be reached to achieve full coverage. there are several factors behind this loss of momentum. although dramatic progress has been made in increasing worldwide vaccination coverage from below % to above %, the task has inevitably become harder now that the easiest-to-reach populations have been vaccinated. because these communities are more elusive, the average cost per vaccination has increased, and it may be that other apparently cheaper health interventions have become more attractive. there are many practical problems impeding vaccine delivery. delivering vaccines to patients requires functioning freezers and reliable transport to move the vaccines from port to clinic; clinics refrigerators (which in turn require a constant supply of energy); good roads and with access to people who need to be immunized; parents who know the value of vaccination; trained medical staff to deliver the dose; and sterile syringes. only % of vaccineimporting countries could guarantee vaccine safety and quality [ ] , while a further study of developing countries found that at least half of injections were unsafe [ , [ ] [ ] [ ] [ ] . the third factor behind the lack of progress in recent years is political. political disruptions have affected coverage in some areas. in somalia and congo, for example, where vaccination rates have fallen rapidly in the past decade, war and social breakdown have impeded public health campaigns, despite "vaccination days" in congo that temporarily halted fighting. gauri et al. have found that the quality of institutions and governance are positively correlated with vaccination coverage [ , ] . politics in the developed world have also played a part. according to a report by the us institute of medicine, in the us vaccine industry was forced to stop offering low-price vaccines to develop-ing countries following congressional hearings that "savaged" the industry for "allegedly subsidizing vaccines for the poor children of the world by charging high costs to us families and taxpayers". as the institute of medicine points out, this move was based on a flawed premise, as the us vaccines would have been developed anyway to protect american children and travelers. public perceptions of vaccination change-as coverage spreads through a community and it reaches a point at which those who are unvaccinated are highly unlikely to catch a disease because herd immunity has set in. at this juncture, it may be more rational for an individual to refuse vaccination in order to avoid any risk of side effects. with the oral polio vaccine, for example, there is a one in a million chance of paralysis, and in societies where mass vaccination has eliminated the disease, the risk of paralysis is greater than that of catching polio itself. what had once been a public and private good is now a public good but a private risk. as more and more people choose to avoid this risk, of course, overall coverage rates decline, and the community is once again exposed to the threat of the disease. public perceptions have been influenced by vaccine scares. controversy and the attendant bad publicity about the safety of vaccines have been abetted by incidents such as the withdrawal of half the us supply of flu vaccines in due to contamination at the manufacturer [ ] . in addition, alarms over the safety of vaccines such as that for measles, mumps and rubella (mmr), which some believe to cause autism, have further fanned the anti-vaccine movement's flames [ ] . in the us, disputes continue to rage about the scientific basis of such claims, but the preponderance of the evidence, according to the us centers for disease control (cdc), says that the mmr vaccine is safe [ ] . in response to these types of controversies in the us, the institute of medicine has called for independent oversight of vaccine safety studies to ensure the fairness and openness of the vaccine safety datalink program, which is overseen by the cdc. as one can see there are many complex factors that have to be considered when bringing vaccination programs into existence. the impact of vaccination of animal diseases on agriculture is typically assessed in quantitative terms-lost revenues; costs of eradication, decontamination, and restocking; and the numbers of affected farms, animals and humans. this approach can be applied universally to all outbreaks in all countries because it normally reflects the hard data supplied by large commercial operations and the estimates by relevant governmental agencies of small farmer impact [ ] . when used exclusively, however, it fails as a barometer, because it does not and cannot factor in the multi-dimensional character of major disease events-and the accompanying societal effects that often get lost when it comes to assessing the damage in developing countries. the quantitative approach must also be interpreted, and cannot be used "as is" for comparing impacts in developed and developing countries. further, while export trade losses in a developing country may be small in terms of the dollar amount, the impact upon its pre-epidemic market share is inevitably greater and more persistent. other impacts such as effects on human health and community stability tend to be more visible and last longer in developing countries, particularly at the village level where animal are husbanded primarily for the benefit of the immediate family, and often in impoverished circumstances [ ] . the consequences of animal diseases in domesticated birds and livestock can be complex and generally go well beyond the immediate effects on affected producers. these diseases have numerous impacts, including: • productivity losses for the livestock sector (e.g. production losses, cost of treatment, market disturbances). • loss of income from activities using animal resources (in such sectors as agriculture; energy; transportation; tourism). • loss of well-being of human beings (morbidity and even mortality rates; food safety and quality). • prevention or control costs (production costs; public expenditure). • suboptimal use of production potential (animal species, genetics, livestock practices). the most direct economic impact of animal diseases is loss of production and/or productivity, and ensuing income losses for farmers [ ] . however, if the economy depends on one or some of the vulnerable products, the impacts can be serious, and local food security can be threatened. the economic impact also depends on response strategies adopted by farmers and possible market adjustments. if the farm economy is diversified or if there are other opportunities to generate income, the impacts can be mitigated. the economic impact also depends on response strategies adopted by farmers and possible market adjustments. the loss of the farmer's "well-being" will generally be lower than the value of the lost product, except where the farmer has few alternatives or is wholly dependent on the affected product, which is quite often the case in developing countries. direct losses are the result of the disease itself (they may be very high when mortality rates are between and %), or from animal health measures (stampingout policies) [ , ] . in vietnam, one of the countries most seriously affected by the avian flu, almost million birds - % of the country's poultry population -had to be destroyed at an estimated cost of us $ million ( . % of gnp) [ ] . the smaller scale producers lost the least in absolute terms, but the most in relative terms, as the outbreak resulted in losses equivalent to upwards of times their daily income (from us $ a day or less). in africa, abortions caused by the rift valley fever virus not only affect birth rates, but also push human consumption of milk downward in the year following an outbreak [ ] . in the dairy farming sector in kenya, it is estimated that losses in milk production accounted for % of all losses caused by an outbreak of foot-and-mouth disease in the s. direct costs are generally well below the indirect costs of animal diseases and are directly linked to the rapid containment of outbreaks: case studies have shown that early detection and the implementation of appropriate measures in the event of an outbreak are essential to help minimize direct losses as much as possible. conversely, inappropriate control and eradication measures are at the root of such endemic situations, which are much more difficult, and infinitely more costly, to keep under control or eradicate. the livestock sector plays a significant role in the economic development of many countries and vaccination can serve as one of the most important means of assuring its health. as such the cost of not developing new and important or properly applied vaccines can have tremendous economic consequences. the production of meat and other animal-based food items generates income, jobs, and foreign exchange for all stakeholders in the animal industries. consequently, an epizootic which could have been otherwise mitigated by vaccination can affect the industry's upstream (inputs, genetic resources) and downstream activities (slaughterhouses, butchering operations, processing, marketing) in terms of jobs, income for the stakeholders in the industry, or market access. a survey by the food and agriculture organization of the united nations (fa ) on avian flu revealed that in the most seriously affected regions of indonesia, % of permanent workers at industrial or commercial farms lost their jobs [ ] . similarly, an outbreak of contagious bovine pleuropneumonia in botswana led to the destruction of more than , animals in the most seriously affected province, and the immediate closure of the export slaughterhouse, which employed persons. owing to the catalyst role of livestock raising in the rural economy as a whole, the costs of the indirect effects of these measures were later estimated to be seven times higher than the costs caused by direct losses [ ] . in vietnam, % of the poorest segment of the population, for which poultry farming accounts for - % of household income, is particularly vulnerable to income losses caused by avian flu. the fao and world organization for animal health (oie) estimate that between one-third and one-half of the populations living in the most seriously affected areas of southeast asia depend on poultry farming for at least a part of their income [ , ] . in france, the leading european poultry producer, it is estimated that farmers affected by the crisis lost % of their income in months (between january and march ). the effects of the production losses are also linked to price variations, which are caused by supply and demand (im)balances. depending on the market, prices can rise sharply (consumer product on the domestic market) or plummet (product banned for export but cleared for consumption on the domestic market, product deemed too dangerous for human consumption or perceived as such). in brazil, where % of products are exported, the price of a day-old chick, an early indicator of a possible change in production, reportedly fell by %. and even in cases where the country is not infected, market uncertainties and the fall in prices prompted the largest producers to cut back production by % this year. loss of access to, or the opportunity to access, regional and international markets generally have more significant economic implications than just production losses. in / , the rift valley fever outbreaks in east africa seriously affected pastoral economies in somalia, with a decline of more than % in exports (which generate more than % of foreign exchange in "somali land"), following an embargo declared by saudi arabia on all animal products from the horn of africa [ , ] . conversely, the world bank has reported that eradication of certain major diseases to facilitate access to "high value" export markets can provide considerable benefits. loss of access to, or the opportunity to access, regional and international markets generally have more significant economic implications than just production losses. uruguay is a good example of a country that gained access to a lucrative market after eradicating foot-and-mouth disease. beef exports increased in volume by more than % and in value by % after the oie declared uruguay to be officially foot-and-mouth disease-free without vaccination in . access to the u.s. market (where prices are double those of the domestic market) provides uruguay with additional revenue to the tune of us $ million each year. a medium-term analysis showed that access to "pacific rim" markets would generate additional revenue of us $ million each year, and yet, before the disease was eradicated, uruguay had been spending (only) us$ million to us $ million each year on vaccines to combat foot-and-mouth disease. in this case, control costs would account for less than % of the revenue generated by exports alone [ ] . animal diseases that could be controlled by vaccination can have major effects on food availability and quality for poor communities. it is well known that agriculture plays an important role in the generation of income and jobs in other sectors but the closeness of this interdependence became particularly obvious during recent epizootics. for pastoral societies, animal husbandry contributes directly and indirectly to food security and to nutrition as a source of quality proteins, vitamins and trace elements, traction, and com-mercially tradable products [ , ] . certain diseases could have significant repercussions on food supply and the nutrition of poor communities that do not have readily available substitute products, which could therefore lead to famine (rinderpest for example). poultry meat is the primary animal protein in africa (which has little to begin with) and the indispensable source of discretionary income for the survival of millions of small farmers. the high mortality rates as a result of avian flu, which is extremely pathogenic, and the sanitary slaughter of poultry would therefore have a negative impact on the food available to the entire population, as well as on rural revenue. furthermore, developing or transition countries which generally have poor public health systems are particularly at risk from zoonoses making vaccination against these diseases particularly important to target. in / a major rift valley fever epidemic in egypt resulted in , human cases and fatalities [ , ] . twenty years later, a new epidemic affected over , persons in east africa, and persons succumbed to the hemorrhagic form of the disease. but zoonoses also affected industrialized countries with high health standards as was the case with the bovine spongiform encephalopathy crisis in europe [ ] . food-borne diseases (over have been classified) are a major source of acute gastroenteritis (which costs the netherlands us $ million per year) and the cause of major morbidity with fatalities among children in the third world [ ] . in the specific case of a pandemic, most of the economic loss is caused by the increase in morbidities and fatalities in the human population and its repercussions on the world economy. the most recent estimates suggest that the "spanish" influenza in caused the death of million persons, that is, . % of the population at the time. the most obvious economic losses were the reduction in quantity and productivity of the workforce, and according to the experts, in the case of a pandemic could represent times more than all the other losses combined [ ] . another category of economic impact is linked to individual strategies to avoid contamination-or to survive possible contamination. the example of the severe acute respiratory syndrome (sars) clearly shows the sharp drop in demand in the services sector (tourism, public transport, retail trade, hospitality and food services) resulting from the combined efforts of individuals to avoid any close contact [ ] . based on the experience with severe acute respiratory syndrome in south-east asia, the world bank thinks that an avian flu pandemic could result in a % loss of the world's gross domestic product and cost the world economy us $ billion in the space of year. the losses are difficult to calculate and would undoubtedly be much more significant in light of the extremely high mortality rates in developing countries which do not have good health care systems. the impact of animal diseases on the tourism and leisure sectors could also be quite significant. the negative effect of foot-and-mouth disease in the united kingdom on these two sectors amounted to us $ billion because of restrictions on access to rural areas and represented more than half of the total cost of the disease [ ] . the federation of american scientists' animal health/emerging animal diseases (ahead) project proposed a major program in sub-saharan africa to detect and document the extent of infectious diseases shared by farm and wild animals, and to supply treatment, prevention and control services to remote communities that have previously been neglected by other programs, both national and international. this program, international lookout for infectious animal disease (iliad), was implemented in south africa [ ] . at the core of iliad is the need for a permanent and sustainable regional program of in situ surveillance designed to detect, monitor, treat, prevent and control infectious diseases with the goals of increasing livestock production in remote farming communities, protecting the health of wild species, building indigenous physical and professional resources, and introducing communications and epidemiology information technologies. transmission of infectious diseases is rampant in remote communities in the sub-saharan region, just as they once were in the united states and as they always are wherever poverty and farming co-exist. diseases shared by wild, farmed and captive/bred animals, and by animals and humans, suppress food production, frustrate species preservation efforts and greatly affect public health. detection, prevention and control of these diseases are an essential element in expanding trade, improving nutrition, exploiting ecotourism and ensuring food security. iliad is structured in the investor mode-an international consortium of donor groups providing short-term developmental assistance with program direction and oversight provided by veterinary diagnostic, public policy and epidemiology experts representing the sub-saharan africa partnership members-the renowned onderstepoort veterinary and exotic disease institutes (ovi) and tuskegee university (tu), and fas-ahead. given positive assessments of the benefits of the program after years, national or provincial institutions will integrate some or all of the activities into their official veterinary and agricultural activities. it is difficult to calculate the cost of the public's loss of confidence in animal industries in their countries, or of an importer country towards the veterinary services of the exporter country. animal diseases can have major effects on food availability and quality for poor communities. consumers' obsessive fear of bovine spongiform encephalopathy (mad cow disease), fed by the media and which a good communication strategy could have prevented, would have tremendous social repercussions on a europe still reeling from long term economic repercussions. in italy, the baseless perception of a food risk related to avian flu coupled with low confidence in public health services eventually resulted in a % reduction in the consumption of poultry and eggs. the loss of confidence by an importer country can trigger a lasting embargo and major economic and social repercussions (arabian peninsula embargo on the horn of africa, affected by the rift valley fever virus). loss of access to, or the opportunity to access, regional and international markets generally have more significant economic implications than just production losses. animal diseases might also have indirect long-term impacts, affecting deferred productivity. this is the case for example of the reduction in the fertility rate of long-cycle species, the effects of which span periods of - years [ ] . in short, the long-term costs of a slow response are rarely taken into account. economic analyses focus primarily on the effects of the outbreaks and rarely take into account the long-term effects of an endemic situation (characterized by less virulent outbreaks which recur for several years). this is the case of classic swine fever in haiti where recurrent outbreaks reduced the usage rate by %, which for pig farmers meant a loss of revenue of us $ . million per year [ ] [ ] [ ] . with major crisis, long-term impacts would make themselves felt, since the additional costs of financing prevention and control measures would lead to an equivalent reduction in savings and investments. for example, the analysis of the global impact of the avian flu crisis in europe was complicated by outbreaks of foot-and-mouth disease in brazil, the largest global exporter of beef and poultry. it is therefore easy to imagine what the combination of these two events would mean in terms of the upward push of prices of all meats, similar to what occurred in with north american beef and bovine spongiform encephalopathy. the european union, a net importer of beef, especially from brazil, would see an increase in the price of beef in its internal markets stemming from the embargo imposed on brazilian beef because of the foot-and-mouth disease. it must be pointed out that the crises could have a cumulative impact, particularly since they are amplified by the effects of globalization the following example therefore illustrates the ripple, spillover and remote effects: in the united states, where % of oleaginous and cereal production is geared towards animal production. an epizootic which reduces animal production by % would have the immediate consequence of the loss of , jobs, a surplus of . ton in cereals and oleaginous products, a % reduction in world trade and, crises in other producing countries. in , nearly americans out of every , died each year of infectious disease. laurie garrett, author of "the coming plague: newly emerging diseases in a world out of balance", writes that in the postwar environment, powerful medical weaponry (antibiotics, vaccines, water treatment, anti-malaria drugs) gave scientists confidence that they could significantly control and/or eradicate infectious disease from viral, bacterial or parasitical sources. in the late s, the surgeon general of the usa, william h. stewart, said that ". . .it was time to close the book on infectious diseases and pay more attention to chronic ailments such as cancer and heart disease." a measure of that success came towards the end of the s, when the world realized that smallpox had become the first disease to be eradicated from the human species. such halcyon days from the s to the early s are but a memory. by , the numbers were down to per , . the "health for all" accord, signed in , set a goal of the year for eliminating many international scourges. but amid all this optimism, the numbers started rising. in , people per , died and we know the rest of the story, . . . or do we? the grandiose optimism rested on two false assumptions; that microbes were biologically stationary targets, that for the most part human and other animal diseases were for the most part limited to those species and geographically sequestered. scientists have witnessed an alarming mechanism of microbial adaptation and change, anything but stationary, microbes and the insects, rodents and other animals that transmit them are in a constant state of biological, ecological flux and evolution [ ] . according to the u.k. centre for tropical veterinary medicine, - % of all the known species of infectious organisms that affect human health (causing a quarter of the world's deaths) can be transmitted by animals. approximately of these infectious organisms are linked to diseases that have only recently emerged, or have increased in severity (and geographic distribution) in recent years. who averages outbreak investigations every year, and around will require an international response. more than new and highly infectious diseases have been identified in the last years. furthermore, known strains of diseases such as tuberculosis, many species of gram positive and negative bacteria as well as many parasites, e.g. malaria, food animal coccidia have developed resistance to various classes of antibiotics, while old diseases have reappeared, such as cholera (in angola, with deaths), yellow fever (new cases recently reported in guinea, sudan, mali, and senegal), plague, dengue fever, meningitis, hemorrhagic fever, measles, mumps, rubella and diphtheria. there are emerging diseases just among marine life, reports the book conservation medicine, and these include tuberculosis in fur seals and chlamydiosis in sea turtles. more staggering than these cited numbers in living animals including humans are those coming out of the microbial genetic sequencing and diversity studies involving the oceans. recent data in this field suggest that the oceans of the world contains approximately ( ) phage particles or virions (cf. million metric tons), much of it turning over once per day and most likely be a regular source for current and future zoonotic and human infections. this vast mutation engine, even if one assumes a minimal mutation rate, generates the equivalent of hundreds of new complete human genomes per day. a -l sample of surface seawater was concentrated; ∼ × ( ) viral particles, the dna once randomly sheared and cloned yielded , fragments for sequencing. data analysis showed that most of the sequences were from previously unknown viruses. approximately . % of the total sequence samples overlapped, suggesting that the marine viral community was highly diverse. a unique mathematical analysis further suggested that approximately ( ) different new viral types may be present. it is obvious from this most recent description that complex and confounding zoonotic interactions can be expected to occur as ecosystems become concentrated and/or diluted during the upcoming environmental and ecological change. this will require a new breed of medical scientists that have foregone the days of super-and sub-specialization and are now grounded in both depth and broad general eco-and bio-medical systems training. few people recognize the broad range of clinical and basic veterinary research and its many important contributions to society in the realms of public health and food safety, vaccination, fertility, drug and vaccine development, surgical techniques and biodegradable materials, space medicine, animal health and welfare, and comparative medicine [ ] . opportunities in veterinary research include comparative studies with animals that shed light on human health problems; the development of tools to better detect, prevent, and control zoonotic diseases (that spread from animals to humans); the establishment of scientifically based policies for the humane treatment of animals; and the development of measures to secure and protect the nation's food supply and farm-animal economy from a potential act of bioterrorism [ , ] . the new complex problems of the new millennium will require new educational models that train para-and professional people for thinking and solving complex inter-related biological, ecological, public-economic problems. the single profession that is most centered on the new paradigm is veterinary medicine. the three major disciplines within veterinary medicine and research -public health, comparative clinical and basic medicine, and animal health -are closely intertwined [ , ] . for example, research in comparative medicine contributes to animal health through the development of preventive medicine and treatment. the study of wildlife diseases contributes not only to wildlife health and conservation, but also to public health because many animal diseases can spread to humans. therefore, collaborative and interdisciplinary research is crucial in translating scientific advances from one traditional discipline to another. however, interdisciplinary research is in many cases hampered by administrative, funding, and cultural barriers between institutions. furthermore, agencies that support veterinary research have specific missions. funding to support proposed interdisciplinary research can be difficult to obtain when it is partially related to the mission of several agencies but does not perfectly fit the mission of any one agency. the future requires the veterinary research community to encourage research funders to develop a long-term interagency strategy for veterinary research [ , , ] . in , rudolph virchow, the father of comparative medicine, stated, "between animal and human medicine there are no dividing lines-nor should there be. the object is different but the experience obtained constitutes the basis of all medicine" [ ] . sir william osler ( - ), considered the best-known physician in the english-speaking world at the turn of the century, called the "most influential physician in history" is quoted as saying "veterinary medicine and human medicine complement each other and should be considered as one medicine." dr. calvin schwabe, a retired uc davis professor of veterinary medicine who pioneered the use of human disease tracking techniques in the study of animal illnesses, a global authority on animal diseases that are communicable to human beings and was an early visionary in a field that today is marked by the emergence of pathogens such as avian influenza, mad cow disease and sars. in , dr. schwabe established the department of epidemiology and preventive medicine at the uc davis school of veterinary medicine-the first of its kind in the world at a vet school. the author of more than publications, he promoted the concept of "one medicine," which attempts to bring the fields of human and animal health care together. to this goal in june of the american veterinary medical association (avma) announced that in partnership with the american medical association (ama) there was an adopted resolution calling for collaboration on a one health initiative. the two national, medical organizations will work collaboratively on areas of mutual medical interest, such as pandemic influenza, bioterrorism risks, biomedical research and will be charged with developing strategies to promote collaboration among the various health science associations, colleges, government agencies and industries. a quote from a ama board member, duane m. cady, md "new infections continue to emerge and with threats of cross-species disease transmission and pandemic in our global health environment, the time has come for the human and veterinary medical professions to work closer together for the greater protection of the public health in the st century," the avma policies supporting the concept of "one health" include: furthermore to strengthen this initiative and give it a renewable funding foundation, it would be recommended to move toward, the creation of: ( ) a specific focus at the national institutes of health (nih) on integrated veterinary research via the roadmap initiativemore specifically to create or combine existing potions of institutes into an institute of comparative medicine (icm); ( ) a joint interagency collaborative programs could also be established to enhance interdisciplinary collaborative research and have either re-routed an/or new congressionally supported intra-mural and extra-mural funding program; and ( ) while working out and introducing the legislative changes for the icm the nih should create a veterinary liaison with all the current institutes like the veterinary-medicine and public-health liaison at the centers for disease control and prevention (cdc) in which a veterinarian, dr. lonnie j. king, was selected to head up the agency's national center for zoonotic, vector-borne, and enteric diseases-a relatively recent creation, the center is dedicated to understanding infectious disease ecology and will help to ensure integration of veterinary and human medical research. the american veterinary medical association, with information provided by many other organizations and institutions, conservatively estimates a current deficit of public health veterinarians (e.g. usda food safety and animal disease control, homeland security, research on domestic and foreign animal diseases, wildlife disease control, laboratory animal care and research) and is expected to increase possibly to , by as the human population increases without intervention. comparably the health resources and services administration (hrsa) in the u.s. department of health and human services (dhhs) released a report in , projecting a shortfall of approximately , physicians in [ ] . if current trends continue, the full time equivalent (fte) physician supply is projected to grow to , by , while demand for physicians will increase to , due to the growth and aging of the u.s. population (physician workforce policy guidelines, ). the report projects shortages will be in greatest in non-primary care specialties. it has been over years since the federal government has allocated funds to increase the number of veterinarians and physicians that graduate each year. to begin to alleviate this problem the veterinary workforce expansion act (s. /h.r. ), which is currently being considered by the united states house of representatives and senate would provide an average of $ million per year for the next years in the form of competitive grants to help increase the number of veterinarians entering public practice. if passed and funded, this bill would allow the nation's veterinary schools and other institutions training public health veterinarians to apply for competitive grants to increase capacity in the form of classrooms, teaching laboratories, research facilities, and administrative space. this bill would be vital to the nation's ability to protect human and animal health, as veterinarians are often the first line of defense for both. the text of the bill can be found at: http://thomas.loc.gov by searching by the bill numbers listed above. a list of co-sponsors to the bill can also be found via that site by selecting the link entitled "bill summary & status". over the past century, humanity has had a devastating impact on the earth's wildlife and ecosystems. we are in fact living through the largest mass extinction since the end of the dinosaurs million years ago. unless effective solutions are found, this new century will see the demise of countless more species and pristine ecosystems, particularly in the tropics. the global society, and what surrounds and influences it, are in profound change. these changes will have very significant impacts on future veterinary medicine and veterinary medical education. there are major demographic, political, environmental, disease, technological, and economic influences, all forcing changes onto society. a few examples illustrate the point [ ] . • with immigration into north america accelerating, combined with a declining birth rate, the ethnic diversity in society will continue to increase, with the associated impact on values. • in , for the first time in history, urban people will outnumber rural people. • political destabilization, inflamed by bio-terrorism and religious fanaticism, is expected to increase. • changes in the atmosphere are causing powerful shifts in the environment (melting of the ice caps, rising sea levels) and in the climate (hurricanes, flooding). • global water shortages, especially in heavily populated areas, will soon approach critical levels. to information and service (http://www.jvmeonline.org/cgi/ content/full/ / / #b #b ). • consumer spending power in emerging economies will go from $ trillion to $ trillion by , but the gap between rich and poor is increasing. how will these changes alter the needs of society? how must academic veterinary medicine adapt to prepare veterinarians to respond to these new needs? clearly, humanity has yet to find a way to live on planet earth in a potentially sustaining manner where by stabilizing flora and fauna remain intact to promote healthy ecosystems diversity for all species including our very ownhumans. for example, it is estimated that the equivalent of six earths would be needed to sustain the current world's population if people everywhere consumed natural resources at the rate we do in the united states. it is interesting to think that vaccination directly or indirectly impacts six of the seven united nations millennium goals. understanding and coping effectively with an emerging crisis may sometimes require the birth of action-oriented "crisis disciplines." conservation medicine: ecological health in practice brings together an impressive group of experts from diverse specialties medicine, veterinary science, conservation biology, epidemiology, parasitology, public health, and others) to examine the links among human health, wildlife health, and ecosystem health and begin to address questions like: • how factors such as climate change, endocrine disruptors, and toxic microalgae affect wildlife and human health; • the importance of biodiversity for human health (as medical models, sources of medicines, factors in the ecology of infectious diseases, and indicators of environmental quality), with a review of biodiversity-related biomedical research projects funded by the national institutes of health from to ; • how the health of rainforest-dwelling peoples depends on such diverse factors as forest integrity, floods, seasonality, community organization, education, gender dynamics, national budgets, and global markets; • how wildlife health relates to environmental security; • the health hazards of ecotourism; • the causes and impacts of emerging infectious diseases of humans and wildlife; • how the health of terrestrial and marine animals and ecosystems are monitored, and descriptions of innovations using stool dna and retrovirus evolution as markers of animal population dynamics, stool hormones to indicate species stress, and animal behaviors as proxies for the health of ecosystems; • how habitat fragmentation and reduced biodiversity can increase the risk of lyme disease infection; • how land use changes such as deforestation and water projects influence the ecology of malaria and other vector-borne infections; • how ecological health and wildlife disease are managed in national parks; • the role of zoos in the recovery and conservation of endangered species; • how reducing the burden of infectious disease among park workers in africa could prevent a devastating epidemic among the world's remaining mountain gorillas; • how efforts to control livestock diseases are affecting wildlife health and ecosystems in botswana; • teaching ecosystem health in an undergraduate medical curriculum. more than one billion poor people in asia and africa are closely linked with animals for their livelihoods and they pay a really high tribute to different animal diseases-one can easily demonstrate that improving animal-health mechanisms at the national and local level, and decreasing this weight of animal diseases, will lead very quickly to the alleviation of poverty for this class of people. the world organization of animal health (oie) brings together chief veterinary officers from countries in an effort to create global standards of animal health and animal welfare robust enough to withstand the daunting challenges of worldwide commerce. with an annual budget of around $ million, it is a significantly smaller organization that its human-health counterpart, the world health organization, which has some $ billion a year expenditure on its programs. last year, over billion food animals were produced worldwide to help feed a population of billion people, resulting in trillions of pounds of animal products distributed worldwide and projections for show that demand for animal products will increase by %, especially in developing countries. this poses unprecedented risks for human safety and will require a closer linking of the two agencies. along with those core concerns, oie also addresses farming practices, analyzes import risks, and mediates bilateral trade disputes among its member countries. among its most important achievements in recent years, has been the eradication of rhinderpest, a centuries-old intestinal disease also known as "cattle plague in some countires." in the early s, rhinderpest wiped out upwards of $ million worth of african livestock, contributing to widespread human famine. in general professional students of veterinary and human medicine are exposed more likely to a more scientifically exposed than a politically exposed culture. animal and human health policies must be science-based the rallying cry that is heard from animal and human health professionals around the world. the second verse of this mantra is often 'science, not politics', as if science is unquestionably 'good' and politics 'evil'. antipathy toward politics is worn as a badge of honor. the crowning moment frequently comes with the proclamation, 'i am a scientist, i want nothing to do with politics. ' the phrase 'science-based' infers that the underlying justification of animal/human health policy is derived from knowledge gathered through the systematic observation of, or experimentation with, phenomena. scientific knowledge implies the compilation and analysis of data by individuals with advanced education in specific disciplines. scientists seek facts, the fundamental truths which explain the world around us. at face value, the 'science, not politics' paradigm has a great deal of appeal. however, the very notion of fundamental truth is illusory, as scientific knowledge changes frequently with new observations and experiments. furthermore, conjecture and refutation characterize the scientific method, with disagreement and debate the recognized features of scholarly pursuit. scientists often reach conflicting interpretations of observational and experimental data. consequently, individual scientists may champion different, even diametrically opposed, sets of ideas and principles, so that any number of alternatives may be justified as 'science-based'. finally, animal health professionals typically consider only the biological and physical sciences as 'true sciences', dismissing the social sciences. politics reflect the human need for organization of authority, whether in public or private life. politics exist whenever two or more people come together. the terms 'office politics' and 'family politics' are recognized as clearly as the collective activities surrounding local or national governance. politics exist even in science, affecting scientific organizations, refereed publications and academe. indeed, politics are inescapable. all public courses of animal/human health action adopted by governments emerge from the interplay of science and politics. the policy-making process is governed by rules and regulations, affected by the organizational culture of the government agencies involved, and constrained by legal authorities, political correctness and resource availability. the animal/human health policy-making process involves consideration of current biological and physical scientific knowledge. policy decisions also consider social science factors including ideologies, economics and public opinion. hence the etiology of animal/human health policy is multifactorial. the current older traditional schools of veterinary and human medicine and future schools of "one medicine" will need to include leadership, economics and local, state, national and international governances courses and better training in mechanisms of public policies and rule making. epidemiologists accept the concept of multifactorial etiology as a basic tenet. we discuss disease in terms of agent, host and environment interactions. the practice of applied epidemiology demands a breadth of knowledge and the ability to work in interdisciplinary teams. the more complex the problem, the greater the demand for additional knowledge and insights. veterinary and human epidemiologists study risk factors for disease in animal/human populations and develop strategies for health promotion and disease control [ ] . unfortunately these are done frequently in a vacuum when in fact the two are inter-related and contributing to the observed and at the time undiagnosed disease spectrum however, animal/human health problems cannot be resolved by consideration of biological and physical factors alone. the veterinary and human (someday to become one and the same) epidemiologist working with field problems soon recognizes the critical role played by people in animal/human health issues. applying epidemiological principles to animal/human disease prevention requires consideration of social issues such as attitudes toward animals, cultural and religious mores, and individuals' willingness and capability to implement the prevention strategies. implementing prevention on a national scale brings additional factors into the equation such as availability of resources, adequacy of veterinary services, and animal health infrastructure, among others. therefore, animal health policy development and imple-mentation require attention to macroepidemiology, the study of all of the economic, social and political inputs which affect the distribution and impact of animal or human disease at the national level [ , ] . the low hanging fruit of yesterdays fields of microbiology, zoonotic and emerging infectious diseases, immunology, antibiotic sensitivity, vaccine development, oncology, anti-viral drugs, public health, ecology, environment, human and animal health, to name a few have been picked. today comparative and interdisciplinary research is critical to translating scientific advances from one discipline or species to another and providing new insights into human health problems. scientific fields such as laboratory animal medicine, pathology, immunology, biophysics, mathematics, bioinformatics, genetics, molecular biology and toxicology, when combined with veterinary medicine, have proven especially relevant to success in biomedical research. veterinarians also have contributed to public health through the care of companion animals. fifty-seven percent of all u.s. households own a dog, cat, or both. in addition, millions of exotic animals, birds, and reptiles are kept as pets [ ] . although pets enrich the lives of humans, they also potentially can threaten public health. veterinarians help educate the public about prevention of zoonoses; vaccinate large numbers of pets for zoonotic diseases, such as rabies and leptospirosis; and reduce the level of ecoparasites that can transmit human diseases and intestinal worms, such as roundworms and hookworms, which can cause serious health problems in humans. the , private-practice veterinarians in the united states form a valuable front line for detecting adverse health events, reducing zoonotic diseases, and delivering public health education. because veterinarians work at the interface of human, animal, and environmental health, they are uniquely positioned to view this dynamic through the lens of public health impact. significant changes in land use, expansion of large and intensified animal-production units, and microbial and chemical pollution of land and water sources have created new threats to the health of both animals and humans [ ] . because animals share human environment, food, and water, they are effective sentinels for environmental, human, and public health problems, including bioterrorism. concerns are increasing about antimicrobial resistance of pathogens, waste and nutrient management, and potential runoffs into streams, rivers, and oceans. food animal and wildlife populations are inextricably linked to some environmental problems. together these have led to creation of a new scientific discipline called conservation medicine and ecosystem health, and veterinarians are assuming a leadership role in the field [ ] . several decades ago, special factors came together to create a new epidemiologic era characterized by increases in emerging and reemerging zoonoses [ ] . humans, animals, and animal products now move rapidly around the world, and pathogens are adapting, finding new niches, and jumping across species into new hosts. in , approximately billion food animals were produced to help feed a world population of . billion persons; the united nations' food and agriculture organization estimates that demand for animal protein will increase by % by , especially in developing countries [ ] . the lessons learned from severe acute respiratory syndrome, west nile virus, monkeypox, and avian influenza are reminders of the need to view diseases globally; integrate animal and public health surveillance, epidemiology, and laboratory systems; and create new strategic partnerships among animal, human, and public health professions [ , ] . veterinarians are essential to the detection and diagnosis of and response to these threats and are integral to first-line defense and surveillance for bioterrorism agents. the convergence of human and animal health drove creation of the newly proposed national center for zoonotic, vector-borne, and enteric diseases. plans are being completed to establish several multidisciplinary state-level zoonosis research and development centers. the veterinary profession has recently gained a important foothold on the health and human services government research institutes at the cdc and evolved in prominence as a member of the health professions and has established its importance and usefulness to human and public health. it is hoped and expected that with the developing visions and challenges outlined in this overview we will see the continued melding of veterinary and human medicine to create new educational programs and tools for developing future leaders for solving globally some of the most challenging public and animal health, ecosystem, and conservation problems of the st century. the value of vaccination world health organization. measles deaths drop dramatically as vaccine reaches world's poorest children the value of vaccination: a global perspective intervention cost-effectiveness: overview of main messages the costs and benefits of front-loading and predictability of immunization. cgd working paper veterinarians in population health and public practice: meeting critical national needs cattle, priests and progress in medicine veterinary medicine: an illustrated history committee on assessing the nation's framework for addressing animal diseases. national research council. animal health at the crossroads: preventing, detecting, and diagnosing animal diseases veterinary medicine and public health at cdc the th anniversary of the veterinary medical corps officers of the u.s. public health service veterinarians and public health: the epidemic intelligence service of the centers for disease control and prevention actual causes of death in the united states primary 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veterinary science committee on increasing veterinary involvement in biomedical research. national research council. national need and priorities for veterinarians in biomedical research animal agriculture and the global food supply. task force report . ames, iowa: council for agricultural science and technology council on graduate medical education. physician workforce policy guidelines for the u.s. for towards a better map: science, the public, and the media. economic and social research council the general epidemiologist: is there a place in today's epidemiology? misleading media reporting? the mmr story vaccine delays hit chiron's recovery. la times ten great veterinary public health/preventive medicine achievements in the united states advance market commitments: a policy to stimulate investment in vaccines for neglected diseases historical comparisons of morbidity and mortality for vaccine-preventable diseases in the united states priorities in developing countries surveillance and monitoring systems for animal health programs and disease surveys committee on assessing the nation's framework for addressing animal diseases, national research council. animal health at the crossroads: preventing, detecting, and diagnosing animal diseases. washington sustainable agriculture solutions (sas)-action report the annual report the annual report understanding and improving health and objectives for improving health. vols an agenda for action: veterinary medicine's crucial role in public health and biodefense and the obligation of academic veterinary medicine to respond investing in health immunization at a glance immunization at a glance world development indicators polio eradication website, global case count measuring the national economic benefits of reducing livestock mortality the primary author wishes to acknowledge and dedicate this paper to the late dr.'s jonas salk and maurice hilleman whose lifetime experiences and contributions are unprecedented in medicine and vaccinology and whom personally encouraged and instilled in me during numerous public and private discussions and meetings the importance of working in and helping to advance the field of vaccinology for the betterment of global human and animal health. key: cord- -byophdo authors: zahid, talal; alyafi, rusha; bantan, noor; alzahrani, rana; elfirt, eman title: comparison of effectiveness of mobile app versus conventional educational lectures on oral hygiene knowledge and behavior of high school students in saudi arabia date: - - journal: patient prefer adherence doi: . /ppa.s sha: doc_id: cord_uid: byophdo objective: this study aimed to evaluate the impact of two different oral health education approaches, a mobile application (the brush dj app) and conventional educational lectures, on the oral hygiene knowledge and behavior of high school children. methods: the research was a cross‐sectional study of students from two public schools in jeddah city, saudi arabia. an eighteen-item questionnaire was used for this purpose. those who completed the baseline questionnaire were allocated to one of two groups: ( ) mobile application and ( ) educational lecture. a follow-up survey was later conducted at three months, which repeated eight of the eighteen questions asked in the baseline survey. the change in oral hygiene attitude and behaviors was compared across both groups. results: the brush dj app was found to be equally effective compared to educational lectures in changing oral health knowledge, attitude and behavior. both groups showed significant improvements in almost all aspects of oral health, except for the frequency and duration of tooth brushing in the app group. there was no change in twice daily tooth brushing of app users, and less than % reported brushing their teeth for minutes. a statistically significant change, however, was noted among lecture group participants in these two areas of oral hygiene routine. the app was also found to be more difficult in usability than educational lectures (p = . ). conclusion: the brush dj app may be a valuable tool to improve oral health knowledge, attitude and behavior. however, the app needs some improvements. the content and features of the app need to be structured in a way that it allows for personalization and is more interactive, practical and user-friendly. oral diseases are major public health problems of considerable social and economic burden, owing to their high prevalence. according to the global burden of disease study , about half ( %) of the world's population is affected by oral diseases. two oral conditions have been reported to account for most of the global oral health burdens: tooth decay (dental caries or cavities) and periodontal (gum) disease. other oral conditions that commonly impact the overall well-being and quality of life include dental trauma, oral cancer, tooth wear (dental erosion, attrition and abrasion), edentulism, cleft lip and palate and oral manifestations of hiv. on a global scale, tooth decay of permanent teeth was found to be the most prevalent of all diseases and periodontal disease was the th most prevalent condition. statically, however, the scenario is far worse for underprivileged people living in developed and developing countries. in most industrialized countries, tooth decay has been reported to affect around - % of schoolchildren as well as adults. notable causes for the high prevalence of dental caries and periodontal diseases are poor oral hygiene, inadequate fluoride exposure and tobacco use. the development of dental caries in the oral cavity can be substantially reduced by ensuring a constant low-level exposure to fluoride. this can be achieved by drinking fluoridated water, using a fluoride-containing toothpaste ( to ppm) or applying a topical fluoride gel. , on the other hand, the prevention of periodontal diseases can be largely achieved by maintaining proper oral hygiene such as daily brushing and flossing. hence, most clinicians now suggest twice-daily tooth brushing with an antimicrobial toothpaste containing fluoride to prevent tooth decay and gum diseases. however, there is also a need to educate people concerning the benefits of healthy oral habits to maintain good oral hygiene. proper knowledge and awareness related to oral health are essential for developing healthy oral hygiene behaviors. this has been demonstrated in earlier studies, which reported a direct association between increased oral health knowledge and better dental care. [ ] [ ] [ ] [ ] [ ] consequently, to effectively prevent and control the prevalence of oral health burdens, it is important to develop healthy oral habits at an early stage of life. hence, school children are the ideal target population given the fact that healthy hygiene behaviors that stem from the school-age years usually carry over into adulthood. however, although a larger body of literature has been published in many countries to evaluate the oral health knowledge, attitudes, and behavior among students, to date little attention has been given to develop effective oral disease preventive programs for this key target group. mhealth or mobile health is an emerging sub-segment of ehealth that involves the use of mobile communication and/or wearable devices to improve the practice of medicine and public health. several recent studies including systematic reviews have suggested the use of mobile devices as an invaluable adjunct, which could help improve the oral hygiene compliance in different age groups. [ ] [ ] [ ] [ ] in addition, it has been shown that the use of mhealth with a conventional oral health education program is more effective in improving compliance among adolescent patients than verbal instructions of oral hygiene alone. , to date, however, only a limited number of studies have been conducted to evaluate the quality and effectiveness of numerous mobile applications developed for improving oral hygiene behavior. this study aimed to assess and compare the impact of two different approaches of oral health education, mobile application and educational lecture, on the oral hygiene knowledge and behavior of high school children. the present study was designed as a quasi-experimental study. the baseline survey was done to assess the knowledge and attitude of high school students towards oral hygiene. a follow-up survey was later conducted at three months to determine whether there was any improvement in oral health knowledge, attitude and behavior. the study protocol was reviewed and approved by the research ethics committee at the king abdulaziz university. the survey was conducted from november to march , using a structured questionnaire that was developed after a thorough literature review. a small working group committee independently reviewed and validated it. study participants were recruited from two public schools (a female governmental school and a male high school) in jeddah city, saudi arabia. the principals of the two schools were contacted, and the permission to visit and conduct the survey was obtained. student participation was completely voluntary. all students who were willing to take part in the baseline and follow-up survey and owned a smartphone, tablet or other smart devices were included. the rationale of the study was explained to prospective students beforehand. written informed consent was obtained from parents, guardians or caregivers of each participant before participation. we performed an a-priori sample size (n) calculation of subjects, considering the frequency and duration of toothbrushing as the main outcomes, fixing an absolute error (d) of % and at type i error (z -α/ ) of %, and with an expected proportion (p) of % estimated from a pilot study. we recruited subjects additionally to address loss to follow-up during the study. the questionnaire an eighteen-item questionnaire was used for the baseline survey. questionnaires were distributed manually in randomly selected classes. collected data included demographics as well as information related to oral hygiene knowledge, attitude, and behaviors. participants who completed the initial survey (baseline) were allocated to one of two groups using simple randomization: (a) mobile application group and (b) education lecture group. the improvement in oral hygiene behavior was compared across both groups. eight of the eighteen questions used in initial survey were repeated in the follow-up survey to assess the change in knowledge and attitudes towards oral hygiene. additional questions were included in the followup survey only to assess the efficacy of the method used (application vs lecture). we used two different approaches of oral health education to determine the oral hygiene knowledge and behavior of high school children: ( ) mhealth and ( ) conventional dental education lectures. in this study, the mobile application used was the brush dj app (ios version . . / android version . . , ben underwood). we selected this application for multiple reasons: it is free and user friendly, listed in the apps library of the national health service (nhs) uk, and reported to be a promising tool that motivates an evidence-based oral hygiene routine. participants of the mobile app group were briefed about the various features of the app and how to install and use it. they were also instructed to use the app twice daily for three months. for the conventional education group, a minute lecture session on good oral hygiene practices was delivered using whiteboard, markers, presentation slides, as well as dental teeth models. a dental hygienist carried out the lecture session. participants of both groups were also supplied with additional learning and/or instruction materials in form of handouts. categorical variables were summarized as counts and percentages. mean and standard deviation were used to summarize the distribution of age. bar plots were used to visualize the responses to attitude and knowledge questions. statistical significance was assessed using chisquare test (or chi-square test of independence where appropriate). the % of positive answers for each question was used as an indicator for the knowledge and attitude towards oral hygiene. mcnemar's test was used to test whether the change in the % of positive answers was significantly different between baseline and follow-up survey within each group. hypothesis testing was performed at . level of significance. a total of students completed the baseline survey questionnaire. of these, respondents were planned to be allocated to the mobile application group and were to the educational lecture group for the follow-up survey. the baseline demographics and the oral health attitudes were not significantly different between the two groups [see table ]. overall, the male to female ratio was comparable in the study cohort ( . % and . %, respectively). the mean age of the included participants was . ± . years. figure outlines the baseline knowledge, attitude and behavior towards oral health among study participants. less than half of the study participants reported using mouthwash while only . % used it correctly (ie, once per day every two weeks) and about % flossed their teeth regularly. when asked about the oral hygiene behaviors, > % of the population reported brushing their teeth twice a day, almost one-third reported using a toothpaste with fluoride and < % reported changing it every three months. nearly % reported having knowledge about the best brushing technique while only . % answered the correct duration for teeth brushing. the frequency of dental visits was largely on demand. only . % reported having a routine dental check-up (at every months). around % of the participants had awareness about the negative impact of poor oral hygiene and % were aware of the main causes of tooth staining. of the students recruited in the baseline survey, ( . %) responded to the follow-up questionnaire ( in the app group and in the educational lecture group). eight questions from the baseline questionnaire were repeated in the follow-up survey. patient preference and adherence : submit your manuscript | www.dovepress.com of the four questions added in the follow-up survey, no significant difference between the two groups was found in three responses [ table ]. overall, almost half of the study participants reported benefitting from the lecture/app to schedule their appointments, around % liked the way of teaching, and nearly % noticed a change in their teeth and gums after using the app/lecture. however, of the two interventions, participants in the app group encountered significantly more difficulties with their intervention compared to those who received the lectures (p = . ). less than % of the participants in the app group reported brushing their teeth until the app music ended at minutes, while more than % of those in the lecture group reported brushing their teeth for minutes as instructed. statistical comparison between the groups was not performed due to the different number of choices across each group. more than % in the app group reported learning the right ways to clean their teeth or gum after watching videos in the app [ figure ]. similarly, around % mentioned taking advantage of the reminder icon in the app. only eight questions were repeated in the follow-up survey. analysis of baseline and follow-up data revealed that the knowledge and attitude of participants towards oral health improved significantly in both groups for almost all aspects except for the frequency of tooth brushing in the app group [see table ]. in the follow-up responses, the use of mouthwash, floss and toothpaste with fluoride, the frequency of toothbrush changing at every months, knowledge regarding the best brushing technique and awareness about the routine dental visit (at every months) were increased among participants of both groups. post-test results showed that the percentage of correct answers was comparatively higher in the app group than the dovepress lecture group for question number and . the opposite was observed for question numbers , and where participants from lecture group gave more correct answers than those who used the app. no statistically significant differences were found between the two groups for the remaining questions. statistical analysis showed that there was no statistically significant interaction between gender and time (p > . ) for the frequency of brushing, frequency of changing the toothbrush, frequency of using mouthwash, best brushing technique, type of toothpaste used, and frequency of dental visit (data not shown). however, the frequency of using floss increased to a higher extent in females ( . % to . %) compared to males ( . % to . %) although these differences were statistically significant only at . level. these non-significant results can be explained by the fact that the percentage of changes was similar across males and females. in the current study, the effectiveness of the brush dj app, which is listed in the nhs choices health apps library, was compared with the conventional means of oral hygiene education. the app was found to be equally effective compared to educational lectures in changing oral health knowledge, attitude and behavior. participants from both groups showed significant improvements in almost all aspects of oral health. the only exception was the frequency of tooth brushing in the app group. our results confirm the findings of earlier studies that increased oral health knowledge and awareness has a positive impact on healthy oral hygiene practices. [ ] [ ] [ ] [ ] [ ] however, it is to be noted that health promotion programs such as oral health education alone may not be sufficient to develop healthy oral hygiene behaviors. such programs can temporarily improve oral health behavior and attitude irrespective of the educational approach; , still, other potential confounders (eg, socioeconomic condition, family situations, peer and social influences, local customs, cultural values and availability of resources) may adversely hinder the development of healthy oral practices. hence, there has been a need for well-structured oral health educational interventions that involve psychological and behavior-change strategies and target a broader goal of making an actual change in attitudes, behaviors, intentions, beliefs and lifestyle. the benefits of using technologies as an educational tool have been highlighted in dental literature. [ ] [ ] [ ] [ ] [ ] smartphones and other mobile devices may be a valuable tool for health promotion, as they are more readily accepted among young people than traditional means of dental education. , , in fact, in clinical settings, dental education apps have been found to improve patient-provider communication. besides, while the conventional dental education programs involve workforce utilization and are difficult to organize, the use of dental education apps may provide an effortless means of delivering health information to a wider audience due to the widespread adoption of mobile devices and their powerful technological advances. , , , in addition, these apps may not only increase knowledge and awareness about maintaining good oral health but also motivate their users to follow an evidence-based oral hygiene routine. in this study, a higher trend of correct answers was observed among students who received educational lectures than those who used the app. our findings can somewhat be considered similar to the findings of a recent randomized controlled trial where the effect of the whiteteeth app was examined on oral hygiene behavior in adolescents. the authors reported that although the mobile app incorporated many behavior change techniques, its effects in changing tooth-brushing frequency and duration were similar to that of usual care. however, the effect of mhealth on school children may also depend on age. in a recently published study on children of to years, zotti et al found mobile apps to be more effective, engaging and fun compared to verbal oral hygiene instructions. the higher trend observed in our study may partly be due to the personalized nature of the educational lectures, as students received individual level oral health education and motivation from a dental professional. it is undeniable that individual-level communication with dentists will have more influence on high school students in making healthcare decisions than an app that attempts to replace a direct patient-provider discussion. , on the other hand, oral health education apps appear to be largely less appealing among school students, as children of this age group tend to use mobile apps mostly for entertainment or gaming purposes rather than education. this has been demonstrated in two recent studies where the authors found that most of the currently available oral hygiene apps lack user engagement and need improvement in terms of aesthetics and information accuracy. , strategies that can be implemented to improve user engagement with an app include ease of use, attractive user interface, unique smartphone features (eg, real-time visualized brushing instructions), and tailored design and information. , , , nevertheless, as suggested by several recently published studies, , , incorporating mobile apps with a standard oral hygiene program may be a more plausible approach for oral health promotion among adolescents than educational lectures alone such as via distance motivational tutoring by a dentist or an educator. another possible reason for the lower trend in the app group might be the differences in correct answers between the two groups at baseline. in fact, the app group participants gave significantly higher correct answers than the lecture group for four of the eight questions repeated in the follow-up survey. nevertheless, the actual reason for this needs further investigation, as the findings could help improve the app and allow inclusion of effective behavior change techniques. in our analysis, it appeared that the brush dj app needs some improvements in several aspects. while the app primarily aims to motivate users to brush twice a day and for minutes by playing music, statistical analysis of baseline and follow-up data revealed no change in twice daily tooth brushing of app users. in addition, less than % reported brushing their teeth for minutes. in contrast, a statistically significant change was noted in these two aspects of oral hygiene routine in lecture group participants. moreover, our findings also sharply contrasted with the results of underwood et al where around % of app users reported brushing at least twice a day and % reported being motivated by the app to brush their teeth for longer. these differences could be in part attributed to the non-user-friendly nature of the app, as around % of app users were not fully satisfied with the way of teaching and % reported encountering difficulty in using the app. in this investigation, however, these app users were not asked why. this needs to be investigated in future studies to help improve the app. there are several limitations to this study. firstly, the results of this study cannot be generalized to saudi young population due to the small sample size and recruitment of participants from two specified schools in jeddah city, saudi arabia. secondly, all information collected in this survey is based on self-reported data of participants. this may have introduced bias due to the chances of falsepositive responses from participants. hence, the data presented on oral health knowledge, attitude and behaviors could be an under-or over-estimation. thirdly, due to logistical constraints, no dental assessment was done to assess the actual oral health status of study participants. this could have allowed for an objective assessment of responses by the participants. other limitations of this study include the cross-sectional design, no adjustment for potential confounders such as socioeconomic condition and social factors, and short time period between baseline and follow-up survey. further research is warranted with a randomized control design to obtain more meaningful outcomes. future studies should also adjust for potential variables and include objective assessment of oral health status before and after the intervention. the use of mobile apps in dentistry may become an alternative to the conventional method of dental education; however, they cannot be a substitute for a direct patient-provider communication. these apps may at best act as a pedagogical enhancing tool in dental education. considering this limitation, such educational apps need to be built through an interdisciplinary collaboration among dentists and other professionals (eg, teachers and psychologists). the developers of these applications also need to involve end-users to design and develop the apps in such a manner that they are more practical and user-friendly. alternatively, if these apps include a feature like distance education or counseling by a doctor or an educator, they can more readily be integrated in the routine dental practice, as this would enable patients to get oral health advice directly from dentists during this covid- pandemic. the present study was conducted to evaluate the effectiveness of two different oral disease preventive approaches, a mobile application (brush dj app) and educational lecture (conventional method), in school children. the use of both the mobile app and educational lecture significantly improved oral health knowledge, attitude and practices among study participants. however, the app was found to be less effective than educational lecture to motivate an evidence-based oral hygiene routine. the brush dj app may be a useful tool to improve oral health knowledge, attitude and behavior. however, it needs some improvements. the content and features of the app needs to be more interactive, practical and user-friendly. the authors report no conflicts of interest for this work. global, regional, and national incidence, prevalence, and years lived with disability for diseases and injuries for countries, - : a systematic analysis for the global burden of disease study oral health, health, and health-related quality of life effective use of fluorides for the prevention of dental caries in the st century: the who approach prevention of dental caries through the use of fluoride-the who approach fluoride and oral health oral health knowledge and habits of senior elementary school students community-based population-level interventions for promoting child oral health el metwally a. oral health knowledge, attitude and behavior among students of age - years old attending jenadriyah festival riyadh; a crosssectional study oral health behaviour and social and health factors in university students from low, middle and high income countries oral hygiene facilitators and barriers in greek years old schoolchildren assessing the impact of oral health on the life quality of children: implications for research and practice the emerging field of mobile health whiteteeth") on improving oral hygiene: a randomized controlled trial a systematic review to assess interventions delivered by mobile phones in improving adherence to oral hygiene advice for children and adolescents effectiveness of a digital device providing real-time visualized tooth brushing instructions: a randomized controlled trial effect of mhealth in improving oral hygiene: a systematic review with meta-analysis usefulness of an app in improving oral hygiene compliance in adolescent orthodontic patients implementing post-orthodontic compliance among adolescents wearing removable retainers through whatsapp: a pilot study the use of a mobile app to motivate evidence-based oral hygiene behaviour oral health knowledge, attitudes and practice behaviour among secondary school children in chandigarh effectiveness of oral health education intervention among female primary school children in riyadh, saudi arabia comparative clinical study testing the effectiveness of school based oral health education using experiential learning or traditional lecturing in year-old children effectiveness of oral health education in children-a systematic review of current evidence the smartphone in medicine: a review of current and potential use among physicians and students healthcare in the pocket: mapping the space of mobile-phone health interventions smartphone interventions for long-term health management of chronic diseases: an integrative review preferences related to the use of mobile apps as dental patient educational aids: a pilot study apps for oral hygiene in children to years: fun and effectiveness the impact of patient-centered communication on patients' decision making and evaluations of physicians: a randomized study using video vignettes mobile apps for oral health promotion: content review and heuristic usability analysis patient focused oral hygiene apps: an assessment of quality (using mars) and knowledge content patient preference and adherence is an international, peer-reviewed, open access journal that focusing on the growing importance of patient preference and adherence throughout the therapeutic continuum. patient satisfaction, acceptability, quality of life, compliance, persistence and their role in developing new therapeutic modalities and compounds to optimize clinical outcomes for existing disease states are major areas of interest for the journal. this journal has been accepted for indexing on pubmed central. the manuscript management system is completely online and includes a very quick and fair peer-review system, which is all easy to use. visit http:// www.dovepress.com/testimonials.php to read real quotes from published authors. key: cord- - v rdz authors: northridge, mary e.; littlejohn, tina; mohadjeri-franck, nathalie; gargano, steven; troxel, andrea b.; wu, yinxiang; bowe, robert b.; testa, paul a. title: feasibility and acceptability of an oral pathology asynchronous tele-mentoring intervention: a protocol date: - - journal: j public health res doi: . /jphr. . sha: doc_id: cord_uid: v rdz introduction: oral cancer remains prevalent, despite being largely preventable. the widespread use of technology at chairside, combined with advances in electronic health record (ehr) capabilities, present opportunities to improve oral cancer screening by dentists, especially for disadvantaged patients with severe health needs. design and methods: using a mixed-methods approach, we will evaluate the feasibility and acceptability of integrating a telementoring component into the identification of oral lesions using the following methods: ) administering provider surveys that consist of a checklist of key components of the intervention based on process, and asking the dental provider subjects if each one was covered; ) conducting semi-structured interviews informed by the consolidated framework for implementation research and the implementation outcomes framework with dental resident subjects to assess specific barriers to sustaining the intervention and strategies for addressing these barriers to facilitate integration of the intervention into the routine workflow of the dental clinics; and ) administering brief exit interviews with patient subjects regarding the acceptability of the intervention to assess satisfaction with the use of intra-oral cameras at chairside to screen for and refer patients with oral lesions and identification of these oral lesions via ehr and secure e-mail tele-mentoring with an oral pathology expert. expected impact of the study for public health: if successful, then later clinical trials will maximize the external validity of the intervention and facilitate the widespread implementation and dissemination of the model for the teaching of dentists and residents, with the ultimate goal of improving patient care. in , an estimated , people in the united states will be diagnosed with oral cavity and oropharyngeal cancer, and an estimated , people will die of these cancers. the primary risk factors for oral cavity cancer are tobacco and alcohol use, , whereas the primary risk factor for oropharyngeal cancer is human papillomavirus (hpv) infection, particularly types and . , oral cancer risks are compounded in low-income, racial/ethnic minority, and immigrant communities by difficulties in accessing health care services and multiple linguistic, cultural, economic, and social barriers. immigrants who have lived in the united states for longer periods of time and possess higher degrees of acculturation may have different cancer risks (e.g., consumption of tobacco and/or alcohol, sexual behaviors) than immigrants who report fewer years of us residence or lesser degrees of acculturation. , for all population groups, cultural beliefs influence both health care choices and service use. for instance, among certain asian subgroups, a strong sense of group collectivism exists, and individuality is submerged in the interest of group welfare. friends, neighbors, and family members are often accessed and consulted before turning to formal health care services, which may delay the identification and diagnosis of cancer, including oral cancer, especially in rural and other remote communities where pathology expertise may be absent. , cancer incidence rates for sites within the oral cavity have generally shown a downward trend over recent decades in the united states, while incidence rates for oropharyngeal cancer have this protocol demonstrates how to utilize implementation science methods to conduct a feasibility and acceptability study designed to integrate a tele-mentoring component into the identification of oral lesions at the dental clinics of a federally qualified health center in brooklyn, ny. it provides a model for embedded implementation research in a low-resource setting that may be adapted for diverse community health centers throughout the united states and the caribbean. the study will evaluate whether or not the use of intra-oral cameras and a tele-mentoring component that facilitates consultation with an oral pathology expert aids in the detection and identification of oral lesions during routine dental visits. [page ] [journal of public health research ; : ] increased during this same time period. , one evidence-based strategy for reducing or preventing cancers at oral cavity sites is to attenuate or eliminate exposures to oral cancer risk factors through education, behavior change, and hpv vaccination, while a second evidence-based strategy is the identification of oral lesions suspicious for pre-malignancy or malignancy by dentists as part of preventive dental visits. suspicious lesions ought to undergo biopsy, whereas any other identified lesions ought to be reevaluated within - days and possibly undergo cytologic evaluation. dental provider shortages, remoteness, funding challenges, and decreased costs, coupled with advances in technology and the ongoing coronavirus virus (covid- ) pandemic, have increased interest in the use of tele-medicine applications. , in recent years, the field of dentistry has benefitted from myriad technological innovations, as is the case with medicine and other health care sectors. among the most important of these advances in dentistry are the use of computers, tele-communications technology, digital diagnostic imaging services, and specialized hardware and software for patient screening and follow-up. technological capabilities that were considered implausible only a few decades ago are now possible in dental care, but implementing and evaluating them in diverse, low-resource dental settings requires the active engagement of key organizational stakeholders and clinical, technological, and scientific experts. by leveraging advanced information technologies, the field of dentistry has unprecedented potential to progress far more in the next decade than it has since its professionalization in the united states in the mid-nineteenth century. new information technologies have not only improved the quality of dental patient management, but have also made it possible to achieve partial or complete management remotely, even at distances of thousands of miles from community health center training sites or dental experts. networking, the sharing of digital dentistry information, and distant consultations, workups, and analyses are handled by a specific branch of dentistry-related telemedicine known as tele-dentistry. , use of diagnostic-imaging multiformat cameras for identification of oral lesions routine screening of the entire oral mucosa, together with risk status assessment, should be recorded in the patient's chart at every dental visit (both negative and positive findings). low-cost intra-oral cameras may facilitate the identification of previously hidden and often overlooked defects in teeth and other parts of the oral cavity. previous reports have documented their use in recording carious lesion appearance in the patient record, and they may also be of significant benefit in monitoring early lesions over time following their detection. , this benefit extends not only to dentists but also to patients, for whom it may be a useful educational and motivational tool. to the best of our knowledge, there are no prior findings in the extant literature regarding the use, accuracy, and cost-effectiveness of intra-oral cameras to screen for oral cancer during preventive dental visits. hence, the proposed study and other research involving tele-dentistry applications are needed to assess the feasibility and acceptability of intra-oral cameras in the detection of non-malignant, pre-malignant, and malignant oral lesions during routine screening by dentists at chairside. dental practitioners have been called "the primary vanguards against oral cancer" and are in a unique position to opportunistically examine the oral cavity and, to a lesser extent, the oropharynx during routine dental visits. moreover, their educational background includes knowledge of the normal and pathological presentation of oral subsites, which is further enhanced during dental residency training. nonetheless, the detection and identification of lesions is hampered by difficulties in visualizing lesions intra-orally and lack of expertise among general dentists in oral cancer detection. we hypothesize that the oral pathology asynchronous tele-mentoring intervention will be both feasible to implement in the dental clinic setting and acceptable to dental patients who visit dental clinics for routine visits. clinicaltrials.gov, nct , registered november , available at: https://clinicaltrials.gov/ct /show/nct ?term=nct &draw= &rank= the aim of the proposed study is to evaluate the feasibility and acceptability of integrating a tele-mentoring component into the identification of oral lesions at the dental clinics of family health centers at nyu langone, a federally qualified health center in brooklyn, ny. the primary objective of this study is to assess the feasibility of the oral pathology asynchronous tele-mentoring intervention in the dental clinic setting. the secondary objective of this study is to assess the acceptability of the asynchronous tele-mentoring pilot intervention to adult dental patients in the dental clinic setting. using a mixed-methods approach, we will evaluate the feasibility and acceptability of integrating a tele-mentoring component into the identification of oral lesions at the following dental clinics of family health centers at nyu langone in brooklyn, ny. this will be achieved through the following methods: ) administering provider surveys (n= ) that consist of a checklist of key components of the intervention based on process, and asking the dental provider subjects at each of the family health centers at nyu langone dental sites if each one was covered; ) conducting semi-structured interviews (n= ) with dental resident subjects at each of the family health centers at nyu langone sites to assess specific barriers to sustaining the intervention and strategies for addressing these barriers to facilitate integration of the intervention into the routine workflow of the dental clinics-the interviews will be informed by the consolidated framework for implementation research (cfir) and the implementation outcomes framework (iof); and ) administering brief exit interviews (n= ) with patient subjects at each of the family health centers at nyu langone dental sites regarding the acceptability of the intervention (the survey will assess patient satisfaction with the use of intra-oral cameras at chairside to screen for and refer patients with oral lesions and identification of these oral lesions via tele-mentoring with an oral pathology expert). if this pilot study proves successful, nyu langone health is equipped with both clinical and organizational expertise in faculty development activities, as well as the existing nyu langone dental medicine national network of video-teleconferencing and web-based educational technology, to scale up the proposed oral pathology asynchronous tele-mentoring intervention for the teaching of dental educators and residents, with the ultimate goal of improving patient care. feasibility will be assessed using provider surveys, semi-structured interviews, and ehr data. we developed a checklist of key components of the intervention based on process and will ask the participating dentists and residents at the family health centers at nyu langone dental clinics if each was covered (see appendix ). this will be completed only once at the end of the implementation phase for each consented dental provider subject, and refer to the intervention experience with a specific consented patient subject. endorsement of of the checklist items ( %) by the dental provider subjects will be considered as the feasibility criterion. moreover, we will allow for open-ended collection of feedback on the feasibility of using the intra-oral cameras for identification of oral lesions as part of the tele-mentoring intervention. semi-structured interviews will also be conducted with dental resident subjects (see appendix ) . we anticipate conducting interviews before obtaining data saturation. the questions will be informed by the cfir and iof constructs and will assess specific barriers to implementing and sustaining the intervention and strategies for addressing those barriers to facilitate integration of the intervention into the routine workflow of the family health centers at nyu langone dental clinics. acceptability will be assessed using patient exit interviews (peis) conducted immediately after the dental visit is completed. specifically, research staff will conduct a brief exit interview with patients at each of the family health centers at nyu langone dental clinics with language interpretation services available regarding the acceptability of the intervention. we developed statements on patient satisfaction with the intra-oral cameras and the overall tele-mentoring intervention that will constitute the pei (see appendix ). patients will be asked the extent to which they agree with each statement (e.g., dentists should discuss with me ways to prevent and screen for oral cancer: strongly agree, agree, disagree, or strongly disagree). the acceptability criterion of the intervention will be that % or more of patients rate all administered acceptability questions as "strongly agree" or "agree." below we describe the soprocare ® intra-oral camera to be used in this study (a full description is available from: https://www.acteongroup.com/us/products/imaging/diagnosticcameras/soprocare). the soprocare ® intra-oral camera is available via commercial vendors to health care providers and is intended for the practice of general dentistry to aid in the diagnosis of pit and fissure caries, visualize anatomical details that are invisible to the naked eye or with a mirror, and highlight dental plaque and gingival inflammation. with regard to oral lesions, the magnification capability of soprocare ® helps to improve detection and identification. images can be captured and stored in any imaging software, including the dexis program within the dentrix ehr, providing the necessary technological tools to practice minimally invasive dentistry. the pi will train and supervise the dental providers, who will implement the study. since the training and practice of the attending dentists and the residents they supervise tends to vary across sites and is a key factor in whether educational interventions work, close attention will be paid to implementation fidelity. the pi has extensive experience in training dental providers to deliver inter-ventions with fidelity, and the nyu langone dental medicine postdoctoral residency program emphasizes both quality clinical care and advanced research training. specifically, the tele-mentoring intervention involves training dental faculty members and residents to use intra-oral cameras to take photographs of oral lesions and place them in the dentrix ehr, along with descriptions of the lesions. this information will then be sent via dentrix ehr to the director of oral pathology, and an initial dummy code entry will be placed in the dentrix ehr. for each patient with a detected lesion, the director of oral pathology will then review the dentrix ehr chart and the uploaded photograph(s) of the lesion(s) found and place his observations in the dentrix ehr. next, the director of oral pathology will discuss his findings with the involved dental faculty member / dental resident via secure nyu langone health e-mail. the dental provider will then enter an apt comment in the dentrix ehr, using the following template: "reviewed entry and contacted patient. follow-up appointment needed / not needed (along with the date of patient contact) for an appointment on (date)." a second dummy code entry will then be placed in the patient record in the dentrix ehr. once a week, the director of oral pathology will receive a dentrix ehr report with the affiliated dummy codes for the tele-mentoring pilot study, and assure that entries for both codes are completed, thus closing the loop on the process. the protocol for the tele-mentoring study was designed by the pi and the director of oral pathology, and is summarized in figure . this workflow will be refined based upon the results of the planned feasibility and acceptability testing. all study activities will take place in the family health centers at nyu langone dental clinics and private offices of nyu langone dental medicine in brooklyn, ny. the peis with patient subjects and the feasibility checklists with provider subjects will take - minutes to complete. the semi-structures interviews with dental resident subjects will take - minutes to complete, and will be digitally recorded and transcribed. the transcriptions will be stored in a secure research electronic data capture (redcap) database. the digital files will be deleted once they are transcribed. no identifying information will be recorded. a sample size calculation is not indicated for this feasibility and acceptability study. all quantitative analyses will be conducted by the data analyst under the direction of the biostatistician. provider survey. the feasibility criterion of the intervention will be the endorsement of of the checklist items ( %) by the dental provider subjects. patient exit survey. the acceptability criterion of the intervention will be that % or more of patients rate all administered acceptability questions as "strongly agree" or "agree" on a likert scale. provider semi-structured interview. all interviews will be transcribed by a transcription company and coded by research team members. the research team members will code individually and then meet to discuss and agree upon the final codes. the analysis of the qualitative data will utilize the techniques of narrative analysis and be guided by the constant comparison analytic approach to identify themes. a consent form and a key study information form specific to the category of subject enrolled (dental patient or dental provider) that describe in detail the study device, study procedures, and risks and possible benefits will be given to each subject and written documentation of informed consent will be required prior to beginning the study. the following consent materials were submitted with this protocol and approved by the irb, and are available upon request from the authors: • consent forms (dental patient and dental provider); and • research subject key study information forms (dental patient and dental provider). all data entered into the research database (in redcap) will be protected by confidential entry codes. locked file cabinets will be used to store materials with identifying information (e.g., consent forms). unique identifiers will always replace patient names in all research databases. all computer systems are protected from possible external access. no internet access is possible with the research systems to be used for this study. in addition, computer records will be maintained in such a way that the patient's name or other obvious identifying information is not accessible in the same file or by using the same code. the digitally recorded interviews will be transcribed. the transcriptions will be kept in a password-protected computer. the files will be deleted once they are transcribed. no identifying information will be recorded. tele-dentistry has been reported to be comparable to face-toface examination for oral screening in a systematic review that used the quality assessment of studies of diagnostic accuracy tool to assess the methodologic quality of studies: sensitivity ( - %), specificity ( - %), positive predictive value ( - %), and negative predictive value ( - %). the potential of our oral pathology asynchronous tele-mentoring intervention to aid in the detection of oral lesions holds promise for reaching patients in rural areas and communities with limited access to care, especially given the covid- pandemic. if the results of this feasibility and acceptability study indicate that further testing of the model is indicated, we plan to partner with clinical trial experts at the perlmutter cancer center at nyu langone health to conduct a real-world efficacy trial at training sites that are part of the nyu langone dental medicine network. the study design includes several limitations. first, the dental clinics at family health centers at nyu langone and the dentrix ehr protocol may not be generalizable to dental clinics at geographically diverse community health centers or other ehrs in use at these sites. hence, adaptations to the tele-mentoring intervention, including security safeguards, may be needed in future trials. second, while most general dentists elect to opportunistically screen their patients for oral cancer, false positive findings can manifest as unnecessary patient anxiety, and can also incur monetary costs, discomfort, and possible side-effects of subsequent biopsies. to reduce the potential for false-positive screening results for seemingly innocuous lesions, dentists should follow up with patients in - days to confirm persistence of the lesion after removing any possible cause. conversely, false negative findings can give rise to a false sense of security and result in patients failing to pursue care should symptoms later arise. thus, use of an intra-oral camera may improve the ability of general dentists to detect lesions in the oral cavity that otherwise may have been missed and merit follow-up. notwithstanding these limitations, this feasibility and acceptability study provides an important first step in implementing a tele-mentoring intervention that has the potential to identify and diagnosis non-malignant, pre-malignant, and malignant oral lesions and improve patient care. if successful, then later trials will maximize the external validity of the tele-mentoring model and facilitate the widespread implementation, dissemination, and sustained utilization of evidence-based oral cancer screening, referral, and care coordination guidelines. figure . workflow for the tele-mentoring pilot study to detect and identify oral lesions at chairside by dental faculty and residents. key statistics for oral cavity and oropharyngeal cancers essentials of oral cancer high-risk human papillomavirus in oral cancer: clinical implications oral health disparities across the life span tobacco use among u.s. racial/ethnic minority groups--african americans, american indians and alaska natives, asian americans and pacific islanders, hispanics. a report of the surgeon general. executive summary knowledge and practice: the risk of cardiovascular disease among asian indians. results from focus groups conducted in asian indian communities in northern california health disparities among asian americans and pacific islanders a better lens on disease thought leaders project: e-health, telemedicine, connected health -the next wave of medicine. createspace independent platform national cancer institute oral cavity and oropharyngeal cancer: changing trends in incidence in the united states and oklahoma oral cancer examinations and lesion discovery as reported by u.s. general dentists: findings from the national dental practice-based research network oral cancer the use of teledentistry for remote learning applications coronavirus disease (covid- ): implications for clinical dental care a systematic review on the validity of teledentistry accuracy of teledentistry examinations at predicting actual treatment modality in a pediatric dentistry clinic the first dental college: emergence of dentistry as an autonomous profession accuracy of teledentistry for diagnosing dental pathology using direct examination as a gold standard: results of the tel-e-dent study of older adults living in nursing homes a systematic review of the research evidence for the benefits of teledentistry early detection of oral cancer: how do i ensure i don't miss a tumour? clinical applications of intraoral camera to increase patient compliance -current perspectives detection and monitoring of early caries lesions: a review reliability of intraoral camera using teledentistry in screening of oral diseasespilot study fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges the patient exit interview as an assessment of physician-delivered smoking intervention: a validation study the authors thank the participating site directors, dentists, dental residents, and patients, without whose support this study would not be possible.ethics approval and consent to participate: this research will be performed in accordance with the declaration of helsinki. the nyu grossman school of medicine institutional review board (irb) reviewed and approved all study procedures on october , (protocol s - ). this approval includes all dental clinics where the research will take place. all health insurance portability and accountability act (hipaa) safeguards will be followed. written consent will be obtained from each subject in accordance with the informed consent procedure included in this protocol. de-identified raw data and materials described in the manuscript are freely available from the corresponding author upon reasonable request. ungard) had no role in the study design; collection, management, analysis, and interpretation of data; writing of the report; and decision to submit the report for publication, and will have no ultimate authority over any of these activities. contributions: men designed the research component of the study and drafted the text of the protocol and other study documents. tl led the regulatory compliance process for the study and ensured that all investigators and staff completed the necessary research ethics training and disclosure of potential conflict of interest (coi) documents. nmf devised the clinical protocol for the study and gained the buy-in of all dental clinic directors. sg conceived of the dentris / dentrix electronic health record (ehr) process for the study, advised on the intra-oral cameras to purchase, and installed all of the hardware and software for use in the study in the dental clinic sites. abt drafted the analysis section of the protocol and contributed biostatistical expertise. yw drafted figure and contributed biostatistical expertise. rbb contributed to the conception and design of the study and provided oral cancer expertise. pat contributed to the conception and design of the study and provided security safeguard expertise and assurance. all authors contributed to the writing of this paper and approved it for publication. the authors declare no potential conflict of interest. key: cord- - tb tkis authors: urooj, uzma; ansari, asma; siraj, asifa; khan, sumaira; tariq, humaira title: expectations, fears and perceptions of doctors during covid- pandemic date: - - journal: pak j med sci doi: . /pjms. .covid -s . sha: doc_id: cord_uid: tb tkis objectives: the aim of this study was to explore the expectations and fears faced by doctors during covid- pandemic. methods: this is a mixed method exploratory survey. a questionnaire exploring expectations of doctors from administration and seniors as well as their fears while working during pandemic, was developed on google survey forms. it included eight closed ended questions and four open ended questions. data was collected through online google survey forms during month of march and april . doctors were approached through email and whatsapp group. results: the mean age of participants was . ± . years. female ( . %) and male ( . %) participated. ( . %) associate professor, ( . %) assistant professor, ( . %) senior residents and ( . %) residents, medical officers and house officers responded to the survey. ( . %) doctors were working in hospitals which were not dealing with covid- . fear included, infecting family members ( . %), rapid spread of disease ( %), complications of disease ( . %), becoming a carrier in ( . %) and ( . %) feared missing the diagnosis. more than % expected from seniors and administration, of providing ppe, facilitation, continue chain of supply of essential items, ensuring doctor safety, avoiding exposure of all doctors and keeping reserve workforce, limiting routine checkups, avoid panic and % had no expectations. conclusion: it was concluded that doctors had their fears and perceptions regarding pandemic which need to be addressed while policy making. they fear wellbeing of their families and contacting covid- , if not provided proper ppe. our study provides insight of expectations, fears and perceptions of our frontline which invariably gives insight of the views of healthcare workers. end of brought the global community to be aware of an emerging health crisis which originated in wuhan china. most of the world was not prepared for a situation in which their whole lives will change so in spite of warning messages, the response by global health community and policy makers was slow. in january the world health organization (who) declared the outbreak of a new coronavirus disease, covid- , to be a public health emergency of international concern. who stated that there is a high risk of covid- spreading to other countries around the world. in march , who made the assessment that covid- can be characterized as a pandemic. so, after an initial mundane response suddenly a mass hysteria and panic were created. there was unfiltered non-scientific information bombardment which affected the health care professionals who are directly exposed to a new virus creating havoc. reason being that they are not aware what they are fighting with no foreseeable cure and large number of their peers being affected or dying. some health workers were facing stigmatization and even their families wanted to be disassociated due to a constant stream of negative news. only recently the media has started giving statistics of recovered people too otherwise the news was filled with just people dying everywhere invariably contributing to stress and restlessness amongst doctors. this outbreak is a unique and unprecedented scenario for most of the health workers and their families too. this is a long-term fight and requires sustained response. staff needs to be protected from chronic stress and poor mental health during this response. this means they will have a better capacity to fulfil their roles. they need a regular up-to-date information and communication in order to avoid confusion and further stresses. the administrators are also facing the same stresses so there should be mutual trust, constant reassurance, availability of ppe, standard guidelines and flexible duty hours. doctors are amongst the people most at risk of getting the disease. it is causing undue stress and restlessness when colleagues are sick or on ventilator in icu due to coming in contact with covid- . most of the doctors have no one else to take care of their children or families during times of self-isolation or quarantine. as every time a doctor falls ill the already strained health system gets a blow. the biggest concern is bringing the virus home to their families. there is also a fear that if they fall ill they will be betraying the health system and their patients as they will not be able to contribute. as new information about the disease is upgraded daily the concerns also rise. the doctor realizes that being young will not be protective or the virus is airborne so from today the protection requirement is different. these challenging times are as hard for the patients, communities as well as the health care staff. there is a need to assess the fears, expectations and perceptions of health care workers in our context as it is a topic which is hardly given any attention. doctors are there to treat but their views should be considered and addressed. this study was conducted to assess the perceptions, expectations and fears of doctors during the covid- pandemic and identify the areas which need to be addressed. a cross-sectional web-based survey was carried out by using google forms. a new questionnaire was developed, after validation from five experts, who were working as medical educationist as well as senior consultants with experience of more than years. it was pilot tested. the final survey consisted of total questions; of which were close-ended and were open-ended. participants included the pakistani as well as few uk . % (n= ), usa . % (n= ) clinicians, who were actively involved in clinical practice and duties during covid- pandemic. sample size was calculated by using open epi calculator. these clinicians included anesthetist, surgeons, physicians, radiologists, pathologists, pediatricians, gynecologists, postgraduate trainees, medical officers & house officers working in various healthcare institutes. the diversity of the group allowed for generalization of results to all specialties to assess the clinicians. opinions from all the angles. after ethical approval er-a/ , and informed consent, participants, selected through purposive sampling, were contacted through e-mails and whatsapp group's anonymity and confidentiality was assured. later, reminders were also sent via e-mails and whatsapp. participants filled questionnaire and returned forms. data was saved in excel sheets directly from the google forms. for close-ended questions frequencies and percentages were calculated. for open-ended questions inductive coding was done in excel. after initial coding, line-by-line coding was done for each response by primary researcher (uu) and the similar codes were grouped together to make themes. frequencies were calculated for each theme. the coding process and themes were cross-checked by four reviewers separately (aa, as, sk, ri) for validation. the study included ( . %) female and ( . %) male participants. . % (n= ) were not aware and . % (n= ) responded "may be". donning and doffing awareness was there in . % (n= ), no awareness in . % (n= ) and "may be" was answer of . % (n= ). following themes were generated from the open-ended questions. to the ill, and will i be getting proper ppe today or not" (p ) -"to adhere to sop regarding patient handling" (p ) -"to be safe, responsible and stick to guidelines but there's a hidden fear as well" (p ) -"that i will get the disease somehow" (p expectations from administration, seniors and peers: there were many expectations from administration, seniors and peers. these are shown in table-ii. to quote few statements in which participants had no expectations from administration % (n= ), such as; -"i don't have any expectations as this is a brand-new front, unprecedented, no one alive has fronted an issue of this magnitude....so i don't expect policies to be perfect....and i know everyone has fear in their hearts.... naturally" (p ) -"no expectations from admin our seniors and colleagues very cooperative we all will beat this war" (p ) -"not a lot" (p ) more than % expected full support, provision of protective equipment, cooperation and organization from administration. family: it won't be wrong to say that % of doctors had feelings, thoughts and expectations centered towards their families. uzma urooj et al. and uncertain conditions of pandemic. in this study significant number of participants expressed feelings of concern, anxiety, uncertainty and stress similar to other studies done which showed same psychological responses while working in highrisk situations. in our study age ranged from - years, . % male and . % females. in another study by kang l et al participants, including ( . %) doctors and ( . %) nurses, completed the survey. a total of . % worked in high-risk departments. majority of the participants were female ( . %) similar to our study and age ranged to years ( . %) which is also in agreement to our study. whenever an epidemic hit there is an element of uncertainty and fear even amongst the health care providers which was evident in. this study as . % of the participants had psychological fears. the fact that covid- is human-to-human transmissible, associated with high morbidity, and potentially fatal may intensify the perception of personal danger. same was the case in our study which showed that doctors while on their way to work thought of their personal protection, avoiding being a carrier, keeping spirits up and sense of responsibility. in our study fear of complications of disease in patients was . %, . % feared infecting family members, . % not diagnosing covid- positive patient, % rapid spread of disease and . % becoming a carrier. a survey conducted in china during the initial outbreak of covid- found that . % of respondents rated the psychological impact of the outbreak as moderate or severe, . % reported moderate to severe depressive symptoms, . % reported moderate to severe anxiety symptoms, and . % reported moderate to severe stress levels. health care workers working in emergency departments, intensive care units, and isolation wards had a greater risk of developing adverse psychological outcomes than those of other departments, because they were directly exposed to the infected patients in a highly demanding environment. expectations of most of the doctors from administration were to provide full support, protective equipment provision, planning and logical distribution of resources in order to gare up for future uncertainty. first and foremost, organizational leaders should provide clear messages that clinicians are valued and that managing the pandemic together is the goal. although global health crises share common characteristics across national contexts, each country has its unique political and social systems that affect information behaviors and environments. our health care workers expected seniors and peers to be more empathetic, cooperative, not to panic, show team work, role modelling and support. few studies have showed that challenges included the need to frequently adjust build to meet rapidly evolving requirements, communication and adoption, and coordinating the needs of multiple stakeholders while maintaining high-quality medical care. support from healthcare authorities, regulators, and the government for doctors making difficult clinical decisions is vital, as is the understanding that they will be supported in the event of adverse outcomes. perceptions of doctors in this study were uncertainty and fear . %, sense of duty . %, depressing circumstances %, anxiety %, and worried . %. such stressful conditions can lead to substantial depression in short term and a much more risk of burn out in long term. another cross-sectional, survey-based study collected demographic data and mental health measurements from health care workers in hospitals from january , , to february , , in china. a total of of contacted individuals completed the survey, with a participation rate of . %. a total of ( . %) were aged to years, and ( . %) were women. of all participant ( . %) were nurses, and ( . %) were physicians. ( . %) worked in hospitals in wuhan, and ( . %) were frontline health care workers. a considerable proportion of participants reported symptoms of depression ( . %), anxiety ( . %), insomnia ( . %), and distress ( . %). all doctors showed concern for carrying the disease to their families and expected support from seniors and administration, leaders should aim to monitor clinician wellness and proactively address concerns related to the safety of clinicians and their families. covid- rapidly spread from a single city to the entire country in just days in china. the sheer speed of both the geographical expansion and the sudden increase in numbers of cases surprised and quickly overwhelmed health services all over the world. need of time is to consider as well as plan before hand and to consider views of our doctors as pertinent. this study was conducted during pandemic and lockdown. there is a need to carry out more studies to explore the environment and working conditions of healthcare workers. it will help policy makers and administration to take appropriate decisions and work as team with motivation during this crisis. covid- pandemic has raised numerous challenges all around the world. the health care system is at breaking point in many developed countries. keeping opinion of doctors in view we need to plan as quickly as possible, to identify how we can reconfigure our services. our frontline medical staff need to be protected both mentally and physically, which can be achieved by working together as a team. mental health strategies to combat the psychological impact of covid- beyond paranoia and panic public mental health crisis during covid- pandemic the covid- outbreak and psychiatric hospitals in china: managing challenges through mental health service reform effects of media reporting on mitigating spread of covid- in the early phase of the outbreak mobidoctor malta vs covid -the war is on! mvsc malta-mobidoctor mobile field hospitals, an effective way of dealing with covid- in china: sharing our experience factors associated with mental health outcomes among health care workers exposed to coronavirus disease unintended consequences of covid- a novel coronavirus emerging in chinakey questions for impact assessment covid- is an emerging, rapidly evolving situation impact on mental health and perceptions of psychological care among medical and nursing staff in wuhan during the novel coronavirus disease outbreak: a cross-sectional study influence of community and culture in the ethical allocation of scarce medical resources in a pandemic situation: deliberative democracy study immediate psychological responses and associated factors during the initial stage of the coronavirus disease (covid- ) epidemic among the general population in china a systematic review of the impact of disaster on the mental health of medical responders covid- : what is next for public health? rapid response to covid- : health informatics support for outbreak management in an academic health system maximizing the calm before the storm: tiered surgical response plan for novel coronavirus supporting clinicians during the covid- pandemic psychological impact and coping strategies of frontline medical staff in hunan between world health organization declares global emergency: a review of the novel coronavirus (covid- ) assistant professor, department of gynae/obs, nums, . asma ansari, mbbs, fcps. associate professor, department of gynae/obs department of gynae/obs, . sumaira khan assistant professor, department of gynae/obs, . humaira tariq assistant professor, department of gynae/obs army medical none. uu: conceived, designed, data analysis and editing of manuscript aa: data analysis and editing of manuscript as and sk: data collection/analysis. ht: data collection. uu: takes the responsibility and is accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.uzma urooj et al. key: cord- -uecdbanf authors: hughes, david; saw, richard; perera, nirmala kanthi panagodage; mooney, mathew; wallett, alice; cooke, jennifer; coatsworth, nick; broderick, carolyn title: the australian institute of sport framework for rebooting sport in a covid- environment date: - - journal: j sci med sport doi: . /j.jsams. . . sha: doc_id: cord_uid: uecdbanf abstract sport makes an important contribution to the physical, psychological and emotional well-being of australians. the economic contribution of sport is equivalent to – % of gross domestic product (gdp). the covid- pandemic has had devastating effects on communities globally, leading to significant restrictions on all sectors of society, including sport. resumption of sport can significantly contribute to the re-establishment of normality in australian society. the australian institute of sport (ais), in consultation with sport partners (national institute network (nin) directors, nin chief medical officers (cmos), national sporting organisation (nso) presidents, nso performance directors and nso cmos), has developed a framework to inform the resumption of sport. national principles for resumption of sport were used as a guide in the development of ‘the ais framework for rebooting sport in a covid- environment’ (the ais framework); and based on current best evidence, and guidelines from the australian federal government, extrapolated into the sporting context by specialists in sport and exercise medicine, infectious diseases and public health. the principles outlined in this document apply to high performance/professional, community and individual passive (non-contact) sport. the ais framework is a timely tool of minimum baseline of standards, for ‘how’ reintroduction of sport activity will occur in a cautious and methodical manner, based on the best available evidence to optimise athlete and community safety. decisions regarding the timing of resumption (the ‘when’ ) of sporting activity must be made in close consultation with federal, state/territory and local public health authorities. the priority at all times must be to preserve public health, minimising the risk of community transmission. on january , the world health organisation (who) reported a cluster of confirmed cases of viral severe acute respiratory syndrome in wuhan, hubei province, people's republic of china, following a novel coronavirus outbreak in december . [ ] coronaviruses, enveloped ribonucleic acid (rna) viruses with surface spikes, are a group of viruses that affect both animals and humans, (loss of smell) and ageusia (loss of taste). [ , ] less commonly reported symptoms include headache, abdominal pain, nausea, vomiting and diarrhoea. [ , , ] in a review of clinical presentations from china, % of infected people have mild symptoms (no respiratory distress), % have severe illness (dyspnoea, tachypnoea and hypoxia) and % have critical illness (respiratory and other organ failure, septic shock). [ ] the observed timeline of symptoms and pathological changes in symptomatic individuals is an influenza like illness (fever, cough and myalgia) in the first few days followed by respiratory symptoms (dyspnoea +/-hypoxia) in the second week of the illness. the characteristic features on chest ct are bilateral, peripheral, multifocal ground glass opacities. [ ] these imaging findings can also be seen in asymptomatic and pre-symptomatic individuals. the median time from onset of symptoms to intensive care unit (icu) admission in the critically ill is days. [ ] in most instances the cause of death is respiratory failure, septic shock or myocardial injury and cardiac failure. [ ] hospitalisation and mortality rates increase with age. case fatality rates (cfr) vary from country to country and are likely to reflect the extent of testing (if only severe cases who present to hospital are tested cfr will appear higher), demographics (regions with a higher proportion of elderly will have higher cfrs) and stress on the health systems (the size of the outbreak versus the capacity to provide ventilatory support). while people of all ages can be affected by covid- , children tend to have a milder illness, lower rates of hospitalisation and asymptomatic carriage is not uncommon. [ ] the proportion of infected individuals who remain asymptomatic is not known as widespread population screening has not been undertaken but reports vary from % to %. [ , ] the proportion of asymptomatic carriage is likely to be higher in a younger population. unlike sars-cov which was most infectious approximately one week after symptom onset, [ ] the most infectious period for sars-cov- is the hours prior to onset of symptoms and the day of symptom onset. [ ] it is estimated that % of infections are transmitted prior to the onset of symptoms in the index case. [ ] this has significant implications for community transmission. several risk factors, other than advanced age, have been found to be associated with severe disease and death. these include; male sex and co-morbidities including diabetes, cardiovascular disease, hypertension, respiratory disease and immunosuppression. [ , , ] the laboratory findings associated with an increased risk of severe disease and death were; leucocytosis, lymphopenia, elevated liver enzymes, elevated inflammatory markers, elevated d-dimer, elevated troponin, eosinophilia and abnormal renal function. [ ] it has been postulated that more severe cases of covid - may be associated with hyperinflammatory syndrome characterised by a fulminant and fatal hypercytokinaemia (cytokine storm) causing multi-organ pathology. [ , ] reports of non-respiratory manifestations of covid- are increasingly being described. while pneumonia is still the most frequent serious manifestation, cardiomyopathy has been reported in one third of critically ill patients in the united states of america. [ ] approximately one third of hospitalised patients display neurological symptoms including headache, dizziness, agitation, delirium, ataxia and corticospinal tract signs. [ ] neurological symptoms are more common in those with severe respiratory disease. [ ] coagulopathies with thrombotic events and elevated phospholipid antibodies have also been described. [ ] to date, there are no clinical data on possible long-term complications of covid- . whether individuals who have been infected and "recovered" have residual organ damage, in particular respiratory or cardiac complications, is unknown at this time. the other current unknown is whether infection confers immunity to future infection and if so, how long that immunity lasts. prevention pre-emptive low-cost interventions such as enhanced hygiene and social distancing measures reduce numbers of cases through several mechanisms. social distancing decreases the risk of transmission by reducing incidence of contact while enhanced hygiene reduces disease transmission, if a contact occurs. [ ] education of the public and enhanced medical resources have also been shown to reduce transmission. [ , , ] the australian governor-general declared a 'human biosecurity emergency period' on march in response to the risks posed by this empowered the australian government to make a series of decisions including prohibition of cruise ships, travel bans (domestic and international), limiting gatherings to two persons (with exceptions for people of the same household and other select groups), and closing a range of indoor and outdoor public facilities. [ ] after peaking in australia in mid to late march , the number of daily new cases of covid- began to drop in response to in australia, indications for conducting testing for covid- have changed over the course of the pandemic, as case definitions have evolved, and testing kits have become more available. [ , ] testing availability was initially limited to patients with relevant symptoms who were returned overseas travellers or known contacts of a covid- case. testing criteria have now broadened gradually, and doctors should refer to current local health guidelines. [ ] there are currently two main types of tests available for sars-cov- :  nucleic acid detection tests: commonly referred to as polymerase chain reaction (pcr) tests detects sars-cov- genetic material. the preferred test to confirm the diagnosis of covid- is pcr testing of nasopharyngeal and/or throat swabs, combined with relevant clinical findings. despite the potential for faecal-oral transmission [ , ] , the role of faecal pcr testing remains unclear. the absence of sars-cov- on a pcr test on a single occasion is insufficient to definitively rule out covid- infection. public health authorities in australia have recommended using multiple samples over multiple days in those whose symptoms are strongly suggestive of ] in general, pcr tests for other respiratory viral infections tend to have a high sensitivity and specificity, although there is limited data specific to covid- . see appendix a for more detailed information regarding testing for sars-cov- . serology tests are available, including point of care (poc) serology tests that can provide results from venous or finger prick samples in - minutes. [ , ] it is likely that antibodies take - days to become detectable after infection, and around % of patients may not produce detectable levels at all. [ ] at present the sensitivity and specificity for serology testing is not well known. in addition to false negatives, false positives may arise from exposure to other coronavirus strains. as serology is testing for antibodies and not the presence of the virus, it does not provide clinically useful information as to whether a patient could be infectious. [ champions (individuals and teams). [ ] the sport sector employs > , individuals and engages > . million volunteers. the economic contribution is equivalent to - % of gross domestic product (gdp). [ ] regular community-based sport participation in australia generates an estimated $ . b value per annum in social capital including direct economic benefits. [ ] australia has enjoyed many benefits as a result of a rich sporting culture. preventative measures taken in australia and other countries, while required to limit the spread of covid- , have impacted upon a range of work and social pursuits including sport activities. the olympic games and the international community". [ , ] there is contested uncertainty about the likely course of the pandemic and the resulting timelines for safe return to training and competition. in professional sport, loss of revenue from sponsorship, gate- takings and broadcast deals has resulted in job losses and reappraisal of operational imperatives. [ ] it is unclear what long-term effects there will be on other factors such as fan engagement, sport participation, employment in the sport industry and athlete/staff welfare. global and national economic conditions will also have repercussions for sport. the covid- pandemic has impacted people in varying ways with many experiencing deteriorations in mental health. [ , ] resumption of sport can significantly contribute to the re- establishment of normality in society, in a covid- environment. some established norms associated with sport from sharing drink bottles, hugging and shaking hands to arenas packed with spectators are the antithesis of social distancing. sport organisations and participants will be faced with complex decisions regarding resumption of training and competition in the current circumstances. the ais, in consultation with sport partners (nin directors, nin chief medical officers (cmos), national sporting organisation (nso) presidents, nso performance directors and nso cmos), has developed a framework to inform the resumption of sport. national principles for resumption of sport formed the foundation of 'the ais framework for rebooting sport in a covid- environment' (the ais framework). given the recency of covid- there is a paucity of research, particularly in athletic populations. the ais framework is based on current best evidence, and guidelines from the australian federal government extrapolated into the sporting context by specialists in sport and exercise medicine, infectious diseases and public health. the ais framework will be regularly updated to reflect the evolving scientific evidence about covid- . the ais framework is a timely tool of minimum baseline of standards, for 'how' reintroduction of sport activity will occur in a cautious and methodical manner, based on the best available evidence to optimise athlete and community safety. the principles outlined in the ais framework apply to high performance/professional, community and individual passive (non-contact) sport. decisions regarding the timing of resumption (the 'when') of sporting activity must be made in close consultation with federal, state/territory and local public health authorities. the priority at all times must be to preserve public health, minimising the risk of community transmission. resumption of sport and recreation activities can contribute many health, economic, social and cultural benefits to australian society emerging from the covid- environment. . resumption of sport and recreation activities should not compromise the health of individuals or the community. . resumption of sport and recreation activities will be based on objective health information to ensure they are conducted safely and do not risk increased covid- local transmission rates. . all decisions about resumption of sport and recreation activities must take place with careful reference to these national principles following close consultation with federal, state/territory and/or local public health authorities, as relevant. . the ais 'framework for rebooting sport in a covid- environment' provides a guide for the reintroduction of sport and recreation in australia, including high performance sport. the ais framework incorporates consideration of the differences between contact and non-contact sport and indoor and outdoor activity. whilst the three phases a, b and c of the ais framework provide a general guide, individual jurisdictions may provide guidance on the timing of introduction of various levels of sport participation with regard to local epidemiology, risk mitigation strategies and public health capacity. . international evidence to date is suggestive that outdoor activities are a lower risk setting for covid- transmission. there are no good data on risks of indoor sporting activity but, at this time, the risk is assumed to be greater than for outdoor sporting activity, even with similar mitigation steps taken. . all individuals who participate in, and contribute to, sport and recreation will be considered in resumption plans, including those at the high performance/professional level, those at the community competitive level, and those who wish to enjoy passive (non-contact) individual sports and recreation. . resumption of community sport and recreation activity should take place in a staged fashion with an initial phase of small group (< ) activities in a non-contact fashion, prior to moving on to a subsequent phase of large group (> ) activities including full contact training/competition in sport. individual jurisdictions will determine progression through these phases, taking account of local epidemiology, risk mitigation strategies and public health capability. a. this includes the resumption of children's outdoor sport with strict physical distancing measures for non-sporting attendees such as parents. b. this includes the resumption of outdoor recreational activities including (but not limited to) outdoor-based personal training and boot camps, golf, fishing, bush-walking, swimming, etc. . significantly enhanced risk mitigation (including avoidance and physical distancing) must be applied to all indoor activities associated with outdoor sporting codes (e.g. club rooms, training facilities, gymnasia and the like). . for high performance and professional sporting organisations, the regime underpinned in the ais framework is considered a minimum baseline standard required to be met before the resumption of training and match play, noting most sports and participants are currently operating at level a of the ais framework. . if sporting organisations are seeking specific exemptions in order to recommence activity, particularly with regard to competitions, they are required to engage with, and where necessary seek approvals from, the respective state/territory and/or local public health authorities regarding additional measures to reduce the risk of covid- spread. . at all times sport and recreation organisations must respond to the directives of public health authorities. localised outbreaks may require sporting organisations to again restrict activity and those organisations must be ready to respond accordingly. the detection of a positive covid- case in a sporting or recreation club or organisation will result in a standard public health response, which could include quarantine of a whole team or large group, and close contacts, for the required period. . the risks associated with large gatherings are such that, for the foreseeable future, elite sports, if recommenced, should do so in a spectator-free environment with the minimum support staff available to support the competition. community sport and recreation activities should limit those present to the minimum required to support the participants (e.g. one parent or carer per child if necessary). . the sporting environment (training and competition venues) should be assessed to ensure precautions are taken to minimise risk to those participating in sport and those attending sporting events as spectators (where and when permissible). . the safety and well-being of the australian community will be the priority in any further and specific decisions about the resumption of sport, which will be considered by the covid- sports and health committee. all community and individual sport participants, parents/guardians of participants, coaches, spectators, officials and volunteers (collectively termed community sport members) and sport organisations must play a role help slow the spread of covid- . the safe reintroduction of community and individual sport requires thorough planning and safe implementation. prior to the resumption of community sport, it is important for sports clubs/groups to safely prepare the sporting environment. a thorough risk assessment must be carried out and preparation will be specific to the sporting environment. a resumption of sport activity should not occur until appropriate measures are implemented to ensure safety of community sport members. education of community sport members about covid- risk mitigation strategies is crucial. education will help to promote and set expectations for the required behaviours prior to recommencing activities. improved health literacy including awareness of self-monitoring of respiratory symptoms (even if mild). community sports may benefit from consulting with local government and public health authorities on education materials and options available. possible education measures include:  provide education material for community sport members to promote required behaviours (e.g. -what is the strategy to ensure that social distancing of at least . m is maintained by community sport members attending training or competition? -what strategies can be used to communicate/inform community sport members of preventive -what is the strategy to reduce in-person contact between athletes and other personnel? -what is the strategy to manage increased levels of staff/volunteer absences? -what is the strategy to reduce risk to vulnerable groups? proposed criteria for resumption of sporting activity initial resumption of community and individual sport will be governed by public health policy and relaxing/increasing restrictions may be required in response to fluctuating numbers of covid- an initial resumption of sporting activity is dependent on several factors:  a sustained decrease in covid- transmission  healthcare system capacity  community sport clubs/groups and individuals making their own risk assessment guided by their local public health authorities (i.e. community sports clubs and individuals cannot restart sport before permitted by local public health authorities but may decide to delay a restart due to their own circumstances / risk assessment). three levels (levels a, b, c) of sporting activities are recommended in the context of a covid- environment (table ) . for each level, permitted activities, general hygiene measures, and spectators, additional personnel considerations are provided as recommendations before the resumption of community or individual sport. a more detailed description of the sport-specific activities has been developed in conjunction with medical staff working within sport (table ) . <insert there should be no unnecessary body contact (e.g. hand shaking, high fives). community sport organisations should minimise unnecessary huddles of spectators. spectators should be encouraged or directed to spread out and maintain social distance. consideration should be given as to whether it is appropriate to serve food and drink at community events, as this will likely encourage spectators to come into close proximity with each other. hand hygiene stations should be placed in high traffic areas and entry/exit points. progression from level a to level b sporting activities will be considered when the local effective reproduction number (r t ) has remained < for two incubation periods (i.e. four weeks) as determined by public health authorities. [ , ] when sport activity has been at level b for a further two incubation cycles without an increase in r t , progression to level c sporting activities can be considered, as determined by with public health authorities. the timing of the progression from level b to level c may be influenced by any evidence of transmission issues within the sporting cohort. community sport members and individuals should not return to sport if in the last days they have been unwell or had close contact with a known or suspected case of covid- . in an environment of community transmission of covid- , any individual with respiratory symptoms (cough, sore throat, fever or shortness of breath), even if mild, should be considered a possible case of covid- . all community sport members must be made aware not to attend sport environments if they are unwell and should use a cautious approach. anyone who is unwell should be referred to a doctor in accordance with local public health authority guidelines. an athlete with a possible case of covid- should refrain from training (even at home) until they have been cleared to do so by a doctor, given the potential for worsening illness. it should also be considered that anyone returning to sport and exercise after a period of social isolation and not exercising regularly may be at an increased risk of injury. clubs and individuals should apply a graded return to mitigate injury risk, understanding that a sudden increase in training load will predispose to injury. [ ] vulnerable groups vulnerable groups such as para-athletes and others with medical conditions may be at increased risk. those with concomitant medical conditions need individualised management in consultation with their regular treating doctor(s) prior to return to training environments. considerations include increased susceptibility to respiratory infections, unique equipment (e.g. wheelchairs) that requires cleaning, accessibility of medical resources, risk of medical sequalae from covid- , and access to alternate training options. athletes/other personnel with concurrent medical conditions including; respiratory or cardiac disease, hypertension, diabetes [ , ] , obesity [ ] and immunosuppression due to disease or medication may be at increased risk. other groups that require special consideration include; individuals over years of age, carers for or a household contact of a vulnerable person, athletes with suboptimal access to medical care (e.g. remote) and aboriginal and torres strait islander communities. there are two separate points to consider for athletes and other personnel who have been infected with covid- , prior to returning to sport:  ensure they no longer pose any infection risk to their community and  ensure they have sufficiently recovered to safely participate in exercise (specifically for athletes and other personnel undertaking physical roles). in both instances, clearance from their doctor is required. athletes and other personnel who have recovered from covid- must satisfy the communicable disease network of australia (cdna) criteria to ensure they are no longer infectious. [ ] while there is increasing research on the multi-organ nature of covid- in the acute phase, there is currently limited research on medium to long-term complications. long-term decreased exercise capacity has been noted following previous coronavirus infections (sars and mers). [ ] athletes and volunteers/officials with physical roles may be at increased risk of health complications after covid- and warrant multidisciplinary specialist medical assessment before resuming high exertion activities. [ , ] they should be instructed to see their local doctor for a full medical review. an outline of the recommended assessment process following a covid- case is illustrated in table . <insert high performance/professional athletes are 'returning to work' and safe resumption of sport in a covid- environment will be a complex process. for high performance/professional sporting organisations, the 'ais framework' is considered a minimum baseline of standards required to be met before the resumption of training and match play. the ais framework provide minimum baseline of standards for 'how' high performance/professional sport activities can be reintroduced based on the best available evidence to ensure the safety of athletes/other personnel and the wider community ( figure ). if sporting organisations are seeking special exemption to recommence activity, they are required to demonstrate to the respective state/territory and/or local public health authorities that they meet the 'ais framework' requirements and are also taking additional measures to prevent the spread of covid- . federal, state/territory and local public health authorities must be closely consulted in decisions regarding the resumption of ('when') high performance/professional sport activities. all individuals and sport organisations must follow directions of the local public health authorities. (table ) . for each level, permitted activities, general hygiene measures, and medical servicing considerations are provided as minimum baseline of standards required to be met by high performance/professional sport before the resumption of training and competition. a more detailed description of the sport-specific activities has been developed in conjunction with medical staff working within sport (table ) . progression from level a to level b sporting activities will be permitted when the local effective reproduction number (rt) has remained < for two incubation periods (i.e. four weeks) as determined by public health authorities. [ , ] when sport activity has been at level b for a further two incubation cycles without an increase in r t , progression to level c sporting activities can be considered, in consultation with public health authorities. the timing of the progression from level b to level c may be influenced by any evidence of transmission issues within the sporting cohort. the assessment process will depend on multiple factors including medical resources, athlete risk factors and sport-specific risk factors. it may be appropriate for an initial screening to be conducted vulnerable groups such as para-athletes and others with medical conditions may be at increased risk. those with concomitant medical conditions need individualised management in consultation with their regular treating doctor(s) prior to return to training environments. considerations include increased susceptibility to respiratory infections, unique equipment (e.g. wheelchairs) that requires cleaning, accessibility of medical resources, risk of medical sequalae from covid- , and access to alternate training options. athletes/other personnel with concurrent medical conditions including; respiratory or cardiac disease, hypertension, diabetes [ , ] , obesity [ ] and immunosuppression due to disease or medication may be there will be athletes/other personnel who have been infected with covid- wanting to return to the sport environment. some individuals may have been infected and not be aware (asymptomatic or minimally symptomatic cases that did not meet testing criteria at the time of illness). athletes/other personnel who have recovered from covid- must satisfy the communicable disease network of while there is growing research on the organ systems affected by covid- in the acute phase, there is currently limited research on medium to long-term complications. long-term decreased exercise capacity has been noted following previous coronavirus infections (sars and mers). [ ] athletes and other personnel with physical roles may be at increased risk of health complications after covid- and warrant multidisciplinary specialist medical assessment before resuming high exertion activities. [ , ] medical clearance of staff may be conducted by the sport, or by external doctors, depending on the individual sport organisation resources and policies. an outline of the recommended assessment process following a covid- case is illustrated in table in australia, currently most respiratory tract infections will be tested for covid- . if an individual is being tested for covid- :  they must immediately self-isolate and discontinue training until covid- has been excluded and they have been medically cleared by a doctor to return to the training environment  isolation of close contacts will be a decision for medical staff, based on case specific details definition of close contacts:  "face-to-face contact in any setting with a confirmed or probable case, for greater than minutes cumulative over the course of a week, in the period extending from hours before onset of symptoms in the confirmed or probable case, or  sharing of a closed space with a confirmed or probable case for a prolonged period (e.g. more than hours) in the period extending from hours before onset of symptoms in the confirmed or probable case  contact is considered to have occurred within the period extending hours before onset of symptoms in the patient, until the patient is classified as no longer infectious by the treating team (usually hours after the resolution of symptoms)". [ ] and key surfaces before/after every patient.  for manual therapy treatment or massage, it is recommended that the athlete and therapist wear a face mask. the therapist must wash their hands before and after treatment, and the athlete should shower before and after treatment. symptoms/illness must be tested for covid- and cleared by a doctor.  unwell athletes should be instructed to see a doctor and must not receive any other type of medical servicing such as assessment for injury (unless urgent) or manual therapy until cleared to do so. detailed description of medical service considerations pertaining to level a, b, c sporting activity is illustrated in table all sectors of society, including sport. in a covid- environment, sport has an important role to play in restoring normality. sport organisations and athletes will be faced with complex decisions regarding resumption of training activities in the current circumstances. 'the ais framework for rebooting sport in a covid- environment' is based on current available evidence, extrapolated into the sporting context by specialists in sport and exercise medicine, infectious diseases and public health. the ais framework provides a timely tool for sport organisations to guide the cautious and methodical resumption of sport activity (the 'how') . decisions regarding resumption of sporting activity must be based on objective medical information regarding the transmission of federal, state/territory and local public health authorities must be closely consulted in decisions regarding the timing of resumption of sport (the 'when'). the ais framework will be updated to reflect the evolving evidence regarding covid- . while navigating the return to sport, organisations must ensure that the health and wellbeing of athletes and other personnel informs decision making. the overriding priority for sport, however, must ensure that any return to activity does not endanger public health.  the overriding priority for sport, however, is to ensure that any return to activity does not endanger public health. activity that can be conducted by a solo athlete or by pairs where at least . m can always be maintained between participants. no contact between athletes and/or other personnel. examples for all sports -general fitness aerobic and anaerobic (e.g. running, cycling sprints, hills) . strength and sport-specific training permitted if no equipment required, or have access to own equipment (e.g. ergometer, weights) . online coaching and resources (e.g. videos, play books). as per level a plus: indoor/outdoor activity that can be conducted in small groups (not more than athletes and/or other personnel in total) and with adequate spacing (not more than person per m ). spitting and clearing of nasal/respiratory secretions on ovals or other sport settings must be strongly discouraged. communal facilities can be used after a sport-specific structured risk assessment and mitigation process is undertaken. 'get in, train and get out' -be prepared for training prior to arrival at venue (minimise need to use/gather in change rooms, bathrooms). minimise use of communal facilities (e.g. gym, court) with limited numbers (not more than athletes/staff in total). have cleaning protocols in place for equipment and facilities. hand hygiene (hand sanitisers) on entry and exit to venues, as well as pre, post and during training. thorough full body shower with soap before and after training (preferably at home). where possible maintain distance of at least . m while training. no socialising or group meals. no spectators unless required (e.g. parent or carer). separate spectators from athletes. spectators should maintain social distancing of at least . m. running, resistance training (solo), skills training (solo). passing, kicking, catching drills. no tackling or grappling. small groups (not more than athletes/staff in total). outdoor range and solo only. full training indoor or outdoor range, with limited numbers / appropriate distancing between athletes. solo training drills only-land based, in own pool or openwater. general fitness, strength work. swimming (own lane). in pool solo technical drills or group technical drills without physical contact. no lifting, holding. outdoor training sessions on own, with coach, or with training partner (no sharing of equipment e.g. javelin, discus, high-jump mats, pole vault, shot put, hammer, starting blocks). full training. avoid running in slipstream of others. running/aerobic/agility training (solo), resistance training (solo), skills training (solo) including kicking, handballing, ball handling skills (e.g. handball against wall, bouncing, ball recovery work). controlled kicking, marking and handball drills. no tackling/wresting, contact, body on body drills. small groups (not more than athletes/staff in total) for both education and training. running/aerobic/agility training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed). full training on court, singles or doubles. running/aerobic training (solo), resistance training (solo), skills training (solo). full training with small numbers (not more than athletes/staff in total). laser run practice in small groups, respecting distance on shooting bench. running/aerobic training (solo), resistance training (solo), simulation work at home if available. full training. running/aerobic/agility training (solo), resistance training (solo), skills training (solo), including shooting (outdoor or own ring only) or ball skills e.g. against a wall to self. skills using netball passing, shooting, defending. small group training (not more than athletes/staff in total) based on skills with set drill, but no close contact/defending/attacking/match play drills. para-athletes require individualised consideration and assessment through all levels (a, b, c) of a return to sport. some para detailed planning and consultation with their regular treating medical team prior to a return to formal training, or progression throu (e.g. wheelchairs, prostheses) will require regular cleaning (for all levels). for more information, refer to the 'ais framework for rebooting sport in a covid- environment' document. for more sport specific guidelines for levels a, b, c, refer to the relevant sport heading in this document. ergometer if access to own at home. cycling (solo), running (solo), resistance training (solo). on-water single. skill drills using a ball, kicking and passing. no rucks, mauls, lineouts or scrums, no tackling/wresting. small group (not more than athletes/staff in total) sessions. solo or double handlers (if allowed by state regulations) only. full training. aerobic/resistance training (solo), technical skills (solo)e.g. standing/holding and dry firing. mental skills traininge.g. concentration/reaction time, visualisation, arousal control). live fire on home ranges only (no club range access). continuation of athlete-led preparation at home. coach-led training including live fire in small groups at authorised venues (i.e. clubs/ranges). outdoor and solo only, or indoor only if have own facilities. full training with appropriate distancing between athletes. running/aerobic training (solo), resistance training (solo), skills training (solo). small group (not more than athletes/staff in total) skills training. aerobic and resistance training (solo), climbing solo/pairs on own wall or outdoors (if allowed by local government). solo hang board training. full training. cleaning of indoor walls required between athletes/groups. solo or with training partner only. full training. in-water training (solo) in own pool or open-water. use of communal pool with limited numbers, athlete per lane. table tennis running/aerobic/agility training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed). full training on court, singles or doubles. running/aerobic/agility training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed). small group (not more than athletes/staff in total) skill sessions only. no matches. in-water training (solo) if access to own pool only, or openwater. use of communal pool with limited numbers and distance maintained. swimming, throwing (passing/shooting) drills. no full contact/defending drills, wrestling. resistance training, technical work at home (no indoor sporting facility / gym access allowed). full training with limited numbers to avoid congestion. aerobic training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed). non-contact shooting, dribbling drills. other non-contact technical /skill drills. small groups (not more than athletes/staff in total). aerobic training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed). non-contact passing drills on court. other non-contact technical /skill drills. small groups (not more than athletes/staff in total). reduced aerobic capacity and increased respiratory distress. potential persisting restrictive lung patterns and reduced diffusion capacity. these respiratory long-term complications been reported follow previous coronavirus epidemics (sars, mers) in non-athlete populations. [ ] clinical assessment graded exercise testing, vo max testing fbe, crp, spirometry, lung ultrasound, chest x-ray, ct chest respiratory review cardiovascular cardiomyopathy [ ] myocarditis [ ] pericardial effusion [ ] arrythmias [ , ] autoimmune mimicry of vasculitis and thrombosis [ , ] a return to exercise with underlying cardiac complications could be contraindicated for some. [ ] return to contact sports / trauma could be contraindicated for some. persisting inflammatory states. clinical assessment -lead ecg, troponins, coagulation profile, crp, echocardiogram, cardiac mri d-dimer, ferritin, c-reactive protein, erythrocyte sedimentary rate cardiology review neurological multiple symptoms and signs have been described. [ ] guillain-barré syndrome [ ] elevated d-dimer [ , ] stroke [ ] encephalopathy [ ] currently unclear as the neurological sequalae from mild to moderate cases is yet to be elucidated. post-viral fatigue is known to occur following other viral infections [ ] and may occur with covid- . monitoring of self-report measures, fatigue symptoms and training loads. mental health symptoms of depression [ ] potential increased risk of post-traumatic clinical assessment and anxiety [ ] both were more common in patients with less social support [ ] stress disorder (ptsd), depression, anxiety. [ ] persistent depression and anxiety have been reported following previous coronavirus epidemics in non-athletic populations. screening questionnaires psychology review and psychiatrist review activity that can be conducted by a solo athlete or by pairs where at least . m can always be maintained between participants. no contact between athletes and/or other personnel. examples for all sports -general fitness aerobic and anaerobic (e.g. running, cycling sprints, hills). strength and sport-specific training permitted if no equipment required, or have access to own equipment (e.g. ergometer, weights). online coaching and resources (e.g. videos, play books). as per level a plus: indoor/outdoor activity that can be conducted in small groups (not more than athletes and/or other personnel in total) and with adequate spacing (not more than person per m ). some sharing of sporting equipment permitted such as kicking a football, hitting a tennis ball, use of a skipping rope, weights, mats. non-contact skills training. accidental contact may occur but no deliberate body-contact drills. no wrestling, holding, tackling or binding. as per lev full sporti size matches). rugby scru for larger separation for some operation no sharing of exercise equipment or communal facilities. apply personal hygiene measures even when training away from group facilities -hand hygiene regularly during training (hand sanitisers) plus strictly pre and post training. do not share drink bottles or towels. do not attend training if unwell (contact doctor). spitting and clearing of nasal/respiratory secretions on ovals or other sport settings must be strongly discouraged. communal facilities can be used after a sport-specific structured risk assessment and mitigation process is undertaken. 'get in, train and get out' -be prepared for training prior to arrival at venue (minimise need to use/gather in change rooms, bathrooms). minimise use of communal facilities (e.g. gym, court) with limited numbers (not more than athletes and other personnel in total). have cleaning protocols in place for equipment and facilities. hand hygiene (hand sanitisers) on entry and exit to venues, as well as pre, post and during training. thorough full body shower with soap before and after training (preferably at home). where possible maintain distance of at least . m while training. no socialising or group meals. return to cleaning m limit unne all consultations undertaken via telehealth unless face to face is considered urgent avoid all routine and non-essential manual therapy. five moments for hand hygiene must be used to minimise the risk of transmission between health professionals and patients. hygiene practises to include no bed linen except single use towels, cleaning treatment beds and key surfaces after each athlete. minimum contact of non-essential surfaces to occur and hands on treatment should be kept to essential only. history taking, or full consultations should be conducted via telehealth if practical. face to face consults should be conducted from at least . m apart when possible, and hands on treatment should be for essential conditions only. a single source therapist is recommended. during any essential manual therapy, it is recommended that the athlete and practitioner wear a face mask. all nonessential athletes and other personnel should avoid the treatment area, and the number of people in treatment areas should be kept to a minimum, following social distancing guidelines. world health organisation. novel coronavirus -china travellers give wings to novel coronavirus ( -ncov). j travel med international travel health: sars (severe acute respiratory syndrome) european centre for disease prevention and control. mers-cov worldwide overview an outbreak of covid caused by a new coronavirus: what we know so far world health organisation herd immunity -estimating the level required to halt the covid- epidemics in affected countries clinical characteristics of hospitalized patients with novel coronavirus-infected pneumonia in wuhan, china detection of sars-cov- in different types of clinical specimens characteristics and outcomes of critically ill patients with covid- in washington state neurologic manifestations of hospitalized patients with coronavirus disease coagulopathy and antiphospholipid antibodies in patients with covid- clinical, laboratory and imaging features of covid- : a systematic review and meta-analysis. travel medicine and infectious disease self-reported olfactory and taste disorders in sars-cov- patients: a cross-sectional study olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (covid- ): a multicenter european study characteristics of and important lessons from the coronavirus disease (covid- ) outbreak in china: summary of a report of cases from the chinese center for disease control and prevention radiological findings from patients with covid- pneumonia in china: a descriptive study. the lancet infectious diseases clinical course and outcomes of critically ill patients with sars-cov- pneumonia in wuhan, china: a single-centered, retrospective, observational study. the lancet respiratory medicine sars-cov- infection in children estimating the asymptomatic proportion of coronavirus disease (covid- ) cases on board the diamond princess cruise ship universal screening for sars-cov- in women admitted for delivery clinical progression and viral load in a community outbreak of coronavirus-associated sars pneumonia: a prospective study baseline characteristics and outcomes of patients infected with sars-cov- admitted to icus of the lombardy region clinical characteristics of patients who died of coronavirus disease in china covid- : consider cytokine storm syndromes and immunosuppression neurologic features in severe sars-cov- infection association of public health interventions with the epidemiology of the covid- outbreak in wuhan, china. jama, . . parliment of australia. covid- human biosecurity emergency declaration explainer world health organisation, laboratory testing for coronavirus disease (covid- ) in suspected human cases neutralizing antibody responses to sars-cov- in a covid- recovered patient cohort and their implications. medrxiv, . . world health organisation presumed asymptomatic carrier transmission of covid- national covid- clinical evidence taskforce. caring for people with world health organisation, clinical management of severe acute respiratory infection (sari) when covid- disease is suspected. . international olympic committee. joint statement from the international olympic committee and the tokyo organising committee game zero?' soccer game attended by , fans likely made this italian city a coronavirus epicenter canberra capitals move one step closer toward wnbl title with thrilling game win over southside flyers official release: nba to suspend season following wednesday's games premier league and british football shuts down until april due to coronavirus -as it happened abc news. new zealand cricket team to return home, postponing odi series with australia super rugby suspended due to coronavirus, jaguares-highlanders cancelled update on covid- : hyundai a-league to play matches behind closed doors a-league to end quickly behind closed doors football: euros and copa america moved to due to coronavirus chao fff media. ffa to postpone remaining matches in the hyundai a-league season due to covid- -organising-committee-and-tokyo-metropolitan-government-announce-new-dates-for- the-olympic-and-paralympic-games-tokyo- . . battett, d. update: pay cut deal ensures 'certainty' in afl industry: aflpa abc news. nrl players lose five months' pay as part of new deal during coronavirus pandemic ca announces staff cutbacks due to coronavirus article: a wake up call: the effects of coronavirus on the sports industry the differential psychological distress of populations affected by the covid- pandemic prevalence and factors associated with depression and anxiety of hospitalized patients with covid- . medrxiv the reproductive number of covid- is higher compared to sars coronavirus are patients with hypertension and diabetes mellitus at increased risk for covid- infection? the lancet respiratory medicine long-term clinical outcomes in survivors of coronavirus outbreaks after hospitalisation or icu admission: a systematic review and meta-analysis of follow-up studies respiratory health in athletes: facing the covid- challenge. the lancet infectious diseases the resurgence of sport in the wake of covid- : cardiac considerations in competitive athletes clinical characteristics of asymptomatic infections with covid- screened among close contacts in nanjing findings of lung ultrasonography of novel corona virus pneumonia during the - epidemic long-term clinical outcomes in survivors of coronavirus outbreaks after hospitalisation or icu admission: a systematic review and meta-analysis of follow-up studies. medrxiv cardiovascular considerations for patients, health care workers, and health systems during the coronavirus disease (covid- ) pandemic covid- ) ct findings: a systematic review and meta-analysis the use of anti-inflammatory drugs in the treatment of people with severe coronavirus disease (covid- ): the perspectives of clinical immunologists from china guillain-barré syndrome associated with sars-cov- unique epidemiological and clinical features of the emerging novel coronavirus pneumonia (covid- ) implicate special control measures large-vessel stroke as a presenting feature of covid- in the young impact of covid : perspectives from gastroenterology kidney disease is associated with in-hospital death of patients with covid- management of chronic (post-viral) fatigue syndrome. the journal of the royal college of general practitioners moments for hand hygiene figure : history of coronavirus epidemics over the past two decades a series of pneumonia cases of unknown cause with clinical presentations resembling viral pneumonia emerged in wuhan, hubeiin province, people's republic of china cluster of respiratory infections in wuhan reported to world health organisation (who) china country office first death of covid- in people's republic of china who first reported a cluster of cases in wuhan, hubeiin province, people's republic of china[ ] people's republic of china shared the genetic sequence of first case of covid- outside of china australian federal government list 'human coronavirus with pandemic potential' in the listed human disease under the biosecurity act , enabling the use of enhanced border measures lock down in hubei province, people's republic of china[ ] confirmed covid- cases people's republic of china and deaths australian federal government increased level of travel advice for wuhan and hubei province in people's republic of china to 'level -do not travel first case of covid- in australia australian federal government advice return travellers who have been in the hubei province, people's republic of china must self-isolated at home for days who declared covid- as a global health emergency australian federal government closed borders for non-citizens and non-residents arrivals from people's republic of china global covid- cases > , and > deaths (in people's republic of china first death of covid- outside people's republic of china covid- cases in the diamond princess cruise ship docked yokohama first cases of community transmission of covid- in australia global covid- cases > , and > french government bans gatherings of > people new zealand government impose mandatory -day self-isolation for all returning travellers australian federal government impose mandatory -day self-isolation for all returning travellers australian government banned international cruise ship arrivals for days who launches solidarity trial (international clinical trial to help find an effective treatment for covid- australian federal government impose a limit of < people for non-essential indoor gatherings and < people for outdoor gatherings, and call to limit non-essential domestic travel australian federal government border closure to all non-citizens and non-residents[ ] march most australian state and territory governments advised against non-essential interstate travel australian federal government impose a ban on all overseas travel 'level -do not travel global covid- cases > , and > , deaths australian federal government impose mandatory day supervised self-isolation at designated facilities (e.g. a hotel) for all returning international travellers the united states is the new epicentre of the covid- global covid- cases > , , and > figure : new and cumulative confirmed covid- cases by notification date in australia groups of single sculls. rugby league running/aerobic/agility training (solo), resistance training (solo), skills training (solo) including kicking, passing, ball skills (e.g. against wall) to self. skill drills using a ball, kicking and passing. no tackling/wresting. small group (not more than athletes/staff in total) sessions. rugby sevens running/aerobic/agility training (solo), resistance training (solo), skills training (solo) including kicking, passing non-contact skill drills using a ball, kicking and passing, small groups (not more than athletes/staff in total) only. no rucks, mauls, lineouts or scrums, no tackling/wresting. rugby union running/aerobic/agility training (solo), resistance training (solo), skills training (solo) including kicking, passing wheelchairs, prostheses) will require regular cleaning (for all levels) on-water single. group resistance training sessions and outdoor group ergometer training placed at least . m apart (not more than athletes/staff in total). groups of single sculls. full trainin rugby sevens running/aerobic/agility training (solo), resistance training (solo), skills training (solo) including kicking, passing non-contact skill drills using a ball, kicking and passing, small groups (not more than athletes/staff in total) only. no rucks, mauls, lineouts or scrums, no tackling/wresting. full trainin sailing solo or double handlers (if allowed by state regulations) only. full training. full trainin shooting aerobic/resistance training (solo), technical skills (solo)-e.g. standing/holding and dry firing continuation of athlete-led preparation at home. coach-led training including live fire in small groups at authorised venues (i.e. clubs/ranges) full trainin skateboarding outdoor and solo only, or indoor only if have own facilities. full training with appropriate distancing between athletes. ful softball running/aerobic training (solo), resistance training (solo), skills training (solo) running/aerobic/agility training (solo), resistance training (solo), skills training and shooting drills (solo) at home or outdoor (no indoor sporting facility access allowed). no ball handling drills with others.non-contact skills using basketball -passing, shooting, defending, screens and team structure (offence and defence). small groups (not more than athletes/staff in total). running/aerobic/agility training (solo), resistance training (solo), technical training (solo). bag work if access to own equipment, without anyone else present.shadow sparring allowed. non-contact technical work with coach, including using bag, speedball, pads, paddles, shields. no contact or sparring. running/aerobic training (solo), resistance training (solo), on-water training (solo).full training. running/aerobic training (solo), resistance training (solo), skills training (solo).nets -batters facing bowlers. limit bowlers per net. fielding sessions-unrestricted.no warm up drills involving unnecessary person-person contact.no shining cricket ball with sweat/saliva during training. solo outdoor cycling or trainer, resistance training (solo). avoid cycling in slipstream of others-maintain m from cyclist in front. avoid packs of greater than two (including motorcycle derny). on-land training only (solo non-contact skills training drills in small groups (not more than athletes/staff in total). running/aerobic/agility training (solo), resistance training (solo), skills training (solo).non-contact skill training drills -passing, shooting, headers. small groups (not more than athletes/staff in total). solo or pairs only (if permitted by local government). full training. resistance training, skills training solo and outside of gym only.rhythmic -skills at home. trampoline -off apparatus skills, drills at home only.small groups only - gymnast per apparatus (including rhythmic and trampoline). disinfecting high touch surfaces as per the manufacturer's guidelines. running/aerobic/agility training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed).skill drills -passing, shooting, defending. no contact drills. small groups (not more than athletes/staff in total). running/aerobic/agility training (solo), resistance training (solo), technical training (solo)-e.g. mirror work.no contact / bouts. non-contact shadow training. non-contact technical work with coach. running/aerobic/agility training (solo), resistance training (solo), technical training (solo)-e.g. mirror work.no contact / bouts. shadow sparring. non-contact technical work with coach, including using pads, paddles. a maximum of people are allowed per green at any one time.all players are to use separate mats and jacks (or ensure that the same player on each rink places mats or places/rolls jacks).other bowls equipment cannot be shared between players (e.g. bowls, cloths, measures) . coaching should be limited to no more than a coach and one other person at the time and all practicing physical distancing of . m during the coaching session.no barefoot bowls activity.a maximum of persons is allowed per green at any one time. bowling clubs may need to have a booking system in place to facilitate (levels a and b). bowling clubs with more than one green need to ensure that compliance is achieved in respect to social gathering restrictions. running/aerobic training (solo), resistance training (solo), skills training (solo).swimming -use of communal pool with limited numbers, athlete per lane. running/aerobic/agility training (solo), resistance training (solo), skills training and shooting drills (solo) at home or outdoor (no indoor sporting facility access allowed). no ball handling drills with others.non-contact skills using basketball -passing, shooting, defending, screens and team structure (offence and defence). small groups (not more than athletes/staff in total). non-contact skills training drills in small groups (not more than athletes/staff in total). running/aerobic/agility training (solo), resistance training (solo), skills training (solo).non-contact skill training drills -passing, shooting, headers. small groups (not more than athletes/staff in total). solo or pairs only (if permitted by local government). full training. full trainin resistance training, skills training solo and outside of gym only.rhythmic -skills at home. trampoline -off apparatus skills, drills at home only.small groups only - gymnast per apparatus (including rhythmic and trampoline). disinfecting high touch surfaces as per the manufacturer's guidelines. running/aerobic/agility training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed).skill drills -passing, shooting, defending. no contact drills. small groups (not more than athletes/staff in total). running/aerobic/agility training (solo), resistance training (solo), technical training (solo)-e.g. mirror work.no contact / bouts. non-contact shadow training. non-contact technical work with coach. running/aerobic/agility training (solo), resistance training (solo), technical training (solo)-e.g. mirror work.no contact / bouts. shadow sparring. non-contact technical work with coach, including using pads, paddles. a maximum of people are allowed per green at any one time.all players are to use separate mats and jacks (or ensure that the same player on each rink places mats or places/rolls jacks). other bowls equipment cannot be shared between players (e.g. bowls, cloths, measures). coaching should be limited to no more than a coach and one other person at the time and all practicing physical distancing of . m during the coaching session. no barefoot bowls activity.a maximum of persons is allowed per green at any one time.bowling clubs may need to have a booking system in place to facilitate (levels a and b). bowling clubs with more than one green need to ensure that compliance is achieved in respect to social gathering restrictions. para-athletes require individualised consideration and assessment through all levels (a, b, c) of a return to sport. some para-athletes wil detailed planning and consultation with their regular treating medical team prior to a return to formal training, or progression through le small group (not more than athletes/staff in total) skills training. aerobic and resistance training (solo), climbing solo/pairs on own wall or outdoors (if allowed by local government). solo hang board training.full training.cleaning of indoor walls required between athletes/groups. in pool water training if access to own pool (consider using swim tether) or open-water only. consider use of wind trainer and treadmill for those in quarantine (who are medically well). avoid cycling in slipstream of others-maintain m from cyclist in front avoid packs of greater than two. avoid packs of greater than running. maintain social distancing while running. use of communal pool with limited numbers, athlete per lane, consider one lane between athletes. running/aerobic/agility training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed).small group (not more than athletes/staff in total) skill sessions only. no matches. in-water training (solo) if access to own pool only, or openwater.use of communal pool with limited numbers and distance maintained. swimming, throwing (passing/shooting) drills. no full contact/defending drills, wrestling. resistance training, technical work at home (no indoor sporting facility / gym access allowed).full training with limited numbers to avoid congestion. full trainin aerobic training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed).non-contact shooting, dribbling drills. other non-contact technical /skill drills. small groups (not more than athletes/staff in total). aerobic training (solo), resistance training (solo), skills training (solo) at home or outdoor (no indoor sporting facility access allowed).non-contact passing drills on court. other non-contact technical /skill drills. small groups (not more than athletes/staff in total). running/aerobic/agility training (solo), resistance training (solo), balance training (solo).use of institute gym facilities and indoor ice surfaces in small groups (< total athletes/support staff). use of acrobatic facilities such as trampoline, bungee and water ramp in small groups with athlete at a time and at least . m distancing to support staff. limited on snow training dependent on travel restrictions. small groups widely spaced, no communal living. full training with small numbers (not more than athletes/staff in total). running/aerobic training (solo), resistance training (solo), skills training (solo).nets -batters facing bowlers. limit bowlers per net. fielding sessions-unrestricted.no warm up drills involving unnecessary person-person contact.no shining cricket ball with sweat/saliva during training. running/aerobic training (solo), resistance training (solo), simulation work at home if available.full training. full trainin running/aerobic/agility training (solo), resistance training (solo), skills training (solo), including shooting (outdoor or own ring only) or ball skills e.g. against a wall to self.skills using netball passing, shooting, defending. small group training (not more than athletes/staff in total) based on skills with set drill, but no close contact/defending/attacking/match play drills. running/aerobic/agility training (solo), resistance training (solo), skills training (solo) including kicking, passing, ball skills (e.g. against wall) to self.skill drills using a ball, kicking and passing. no tackling/wresting. small group (not more than athletes/staff in total) sessions.full trainin key: cord- -dgkfxkfh authors: whaibeh, emile; mahmoud, hossam; naal, hady title: telemental health in the context of a pandemic: the covid- experience date: - - journal: curr treat options psychiatry doi: . /s - - - sha: doc_id: cord_uid: dgkfxkfh nan on march , , the world health organization declared coronavirus disease (covid- ) as a pandemic [ ] . the rapidly spreading and deadly virus has infected over nations, including the usa, where it has been declared a public health emergency [ ] . as part of their mitigation strategies, the centers for disease control and prevention recommend limiting community movement and practicing social distancing [ ] , and the federal government recommends avoiding gathering of groups of more than people [ ] . coping with the illness of self, family, or loved ones while managing hospital-or home-based isolation may be stress-provoking, and with the crisis projected to last weeks to months, it is expected that mental health conditions will only worsen over time. infected people experience elevated stress levels due to fear, uncertainty, financial stress, and limited inperson interactions [ , ] . as a result, and paired with confinement in limited spaces, generally, in singlepatient rooms with restricted movement and contact precautions from the health personnel [ ] , people are more likely to experience anger, confusion, hopelessness as well as present symptoms of anxiety, depression, and post-traumatic stress disorder [ , ] . similarly, asymptomatic people with potential exposure, generally in self-imposed home quarantine, may also report distress, frustration and fear as a result of long quarantine duration, risk perception, and inadequate information [ , ] . moreover, people with pre-existing mental health conditions are disproportionately affected since they are more susceptible to stress than the general population [ ] . not only is the treatment of people with mental health comorbidities more challenging and possibly less effective [ ] , but also those who need ongoing evaluations and treatment might not be able to access mental health services for logistic reasons such as travel restrictions and risk of infection [ ] . disruption in care is concerning as it increases the risk of symptom exacerbation and relapse. despite the aforementioned adverse repercussions, contact precautions and public health recommendations have to be implemented. accordingly, alternative methods to deliver mental health care are necessary to bridge the significant health gap, and telemental health has a unique potential in addressing the psychological side effects of social distancing. telemental health refers to the use of information and communications technologies, including videoconferencing, to deliver mental health care remotely, including evaluations, medication management, and psychotherapy [ ] . telemental health has been successfully implemented with multiple populations, across a wide range of mental health conditions, and multiple clinical settings [ , ] . among its many proven advantages, its most pertinent utility to the current situation is to expand access to care for hard-to-reach and underserved populations with restricted mobility due to mental, medical, or geographical challenges. telemental health reduces or eliminates the need for travel for both patients and clinicians and delivers remote services costeffectively while maintaining the quality of care [ ] . as a result, in times of public health crises and national and international emergencies, the value of telemental health cannot be overstated. the covid- is highly contagious and may be deadly for at-risk and elderly individuals [ ] . however, these risks should not prohibit individuals from receiving mental health care. therefore, telemental health may be an ideal solution to reduce the risk of clinicians or patients being infected while still providing care, especially in settings with shortages of mental health professionals. the value proposition of telemental health is that it can effectively respond to the mental health needs of people in isolation, quarantine, or restricted mobility while reducing patient and clinician infection risk. thus, telemental health adheres to social distancing, avoids care interruptions, and maximizes public health outcomes. significant steps have been taken at multiple levels. on the reimbursement front, under the section waiver, the centers for medicare and medicaid services (cms) waived restrictions on originating sites for telehealth, including telemental health, during the crisis [ ] . prior to the implementation of this waiver, medicare reimbursement had significant geographic and originating site restrictions for telehealth services [ ] . this waiver means that reimbursement would occur regardless of whether the patient is seen while at home or a healthcare facility. at the regulatory level, the ability of healthcare professionals to prescribe remotely has been expanded to cover controlled substances [ ] . the ryan haight online pharmacy consumer protection act restricts the prescribing of controlled substances via telehealth, with certain exceptions [ ] . the drug enforcement administration (dea) leveraged the public health emergency exception to the ryan haight act, thus lifting the restriction on prescribing controlled substances through telehealth [ ] . the exception remains applicable as long as the public health emergency, declared by the secretary of the department of health and human services, is in effect [ ]. these steps will enhance the healthcare system's ability to continue to provide telemental health services during this public health emergency. further action by policymakers and public health decision-makers is needed to build on these initiatives and supports the provision of telemental health services, throughout this crisis and beyond. we urge related personnel to consider the following recommendations: & from a public health perspective, it is important to prioritize the allocation of public and private funding and resources to expand the implementation of telemental health and its integration across multiple clinical settings, including primary care. funneling funding in this direction may contribute to enhanced preparedness and management of current and future similar public health crises. the funding should also be complemented by training clinicians and familiarizing patients with the use of telemental health to overcome travel restrictions, to maintain access to treatment when mobility is compromised. additionally, it may be essential to facilitate setting the infrastructural landscape for telemental health in terms of hardware and software in preparation, which includes enhancing connectivity and expanding access to broadband high-speed internet across the country. & from a reimbursement perspective, the lifting of cms reimbursement restrictions, including those based on originating site and geographical locations of patients, should be made permanent. expanding access to mental health services across the country contributes to supporting the continuity of care, particularly since the repercussions of this public health crisis are likely to be long term. furthermore, efforts should be made to urge private payers and managed care organizations to expand telemental health coverage, with the goal of achieving full parity for mental health services regardless of whether delivered in person or remotely. & from a regulatory perspective, the temporary lifting of the ryan haight online pharmacy consumer protection act restriction on prescribing controlled substances via telemental health should be made permanent in order to ensure expanded access to care continues after the public health crisis is declared to be over. lobbying for policy reforms by professional societies, such as the american telemedicine association and american psychiatric association, is needed to achieve this goal, particularly that the act was passed in [ ] , and the landscape of telemental health has rapidly evolved since. & given that state licensure has been a documented barrier to the expansion of telemental health [ ] , it is crucial to temporarily suspend restrictions on licensure requirements to practice telemental health across state lines, to regions of the country that are most impacted by the pandemic [ ] . in the long term, it is important to expand processes that facilitate interstate licensure for better preparedness for future crises. & finally, in the context of a public health crisis of this magnitude, and with the rapidly changing landscape of regulations and reimbursement for telemental health, consistent access to reliable information and updates on regulatory and reimbursement changes is crucial. while we urge healthcare professionals to remain vigilant and up to date, we also urge cms, dea, and other health authorities to continue to provide regular and clear guidance to healthcare professionals as we work diligently to overcome the covid- public health crisis. the rapid spread and high economic cost of covid- have exposed the shortcomings of the healthcare system writ large and have highlighted the urgency of rethinking how services are delivered in the usa. social distancing measures paired with the realization of politicians, policymakers, and citizens of the importance of telehealth in the context of the pandemic are likely to lead to a significant shift in attitudes and behavior and result in a larger-scale adoption of telehealth in the long term. while we welcome the temporary changes made to improve access to care and address the psychological side effects of quarantine and isolation, we believe that some of these changes should be made permanent. moving forward, the integration of telehealth, particularly telemental health, should not be seen as a temporary fix in times of emergency; rather, it is a safe, effective, convenient, scalable, and sustainable method of healthcare delivery that is as crucial as it is inevitable. world health organization. who director-general's opening remarks at the media briefing on covid- - azar declares public health emergency for united states for implementation of mitigation strategies for communities with local covid- transmission white house issues new guidelines for stopping the spread of coronavirus a mental health response to infection outbreak on sars type economic effects during infectious disease outbreaks the psychological impact of quarantine and how to reduce it: rapid review of the evidence sars control and psychological effects of quarantine patients with mental health disorders in the covid- epidemic telepsychiatry: benefits and costs in a changing health-care environment telepsychiatry: videoconferencing in the delivery of psychiatric care report details national shortage of psyciatrists and possible solutions overcoming barriers to larger-scale adoption of telepsychiatry cms approves first state request for medicaid waiver in florida dea okays telehealth to prescribe opioids amid covid- emergency [internet]. mhealth intelligence prescribing controlled substances without an in-person exam: the practice of telemedicine under the ryan haight act. becker's healthcare covid- information page ( th): ryan haight online pharmacy consumer protection act of trump declares covid- emergency, asks hospitals to activate emergency plans conflict of interest emile whaibeh declares that he has no conflict of interest. hossam mahmoud declares that he has no conflict of interest. hady naal declares that he has no conflict of interest. this article does not contain any studies with human or animal subjects performed by any of the authors. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -wyzmziiy authors: narla, nirmala p.; surmeli, aral; kivlehan, sean m. title: agile application of digital health interventions during the covid- refugee response date: - - journal: annals of global health doi: . /aogh. sha: doc_id: cord_uid: wyzmziiy the intersection of digital health platforms and refugee health in the context of the novel coronavirus disease (covid- ) has not yet been explored. we discuss the ability of a novel mobile health (mhealth) platform to be effectively adapted to improve health access for vulnerable displaced populations. in a preliminary analysis of syrian refugee women, we found positive user feedback and uptake of an mhealth application to increase access to preventive maternal and child health services for syrian refugees under temporary protection in turkey. rapid adaptation of this application was successfully implemented during a global pandemic state to perform symptomatic assessment, disseminate health education, and bolster national prevention efforts. we propose that mhealth interventions can provide an innovative, cost-effective, and user-friendly approach to access the dynamic needs of refugees and other displaced populations, particularly during an emerging infectious disease outbreak. in turkey, even prior to the current covid- crisis, syrian refugees faced many challenges in accessing healthcare. although turkey does offer free healthcare to registered refugees in the city within which they are registered through national insurance, mass migration and overstretched health services have complicated efforts to deliver effective care [ ] . multiple barriers to care access exist, including language differences, navigational challenges, lack of medical records, fear of deportation, and xenophobia [ ] . further, refugees experience many conditions that are characteristic of poor social determinants of health: low socioeconomic status, social exclusion, baseline poor nutrition, and unsafe living conditions [ ] . refugee women are considered to be doubly vulnerable, as members of a group that experiences more than one factor diminishing their autonomy. as the study of doubly vulnerable groups presents unique challenges, healthcare needs and concerns of this population are less frequently addressed in the scientific literature [ ] . such vulnerabilities and disparities in access to care and social determinants of health are amplified by covid- . for example, rapid information dissemination is particularly challenging for refugee populations that may not speak the majority language of the country they are in. in some settings, the widespread panic was reported to quickly spread through refugee camps due to the lack of information and misinformation among residents who are already "primed for anxiety" [ ] . the lack of refugeespecific modalities of care and strategies for information dissemination puts these refugees at risk for poor health outcomes, similar to other vulnerable populations [ ] . team-based care with end-user directed approaches to identify, closely follow up, and support refugee patients has been shown to be an effective model for improving health care in refugee camps [ ] . currently, most the intersection of digital health platforms and refugee health in the context of the novel coronavirus disease (covid- ) has not yet been explored. we discuss the ability of a novel mobile health (mhealth) platform to be effectively adapted to improve health access for vulnerable displaced populations. in a preliminary analysis of syrian refugee women, we found positive user feedback and uptake of an mhealth application to increase access to preventive maternal and child health services for syrian refugees under temporary protection in turkey. rapid adaptation of this application was successfully implemented during a global pandemic state to perform symptomatic assessment, disseminate health education, and bolster national prevention efforts. we propose that mhealth interventions can provide an innovative, cost-effective, and user-friendly approach to access the dynamic needs of refugees and other displaced populations, particularly during an emerging infectious disease outbreak. healthcare efforts for refugees focus on strengthening the supply side without specifically targeting the demandside, or individual patient, barriers to access. for example, despite large scale public health efforts and awareness campaigns by the united nation high commissioner for refugees (unhcr), the turkish ministry of health (moh), and the world health organization (who) [ ] , uptake remains low for preventive healthcare services such as childhood immunizations and antenatal care. many refugees do not take advantage of these disease prevention interventions [ ] . it has been estimated that up to date immunization levels are under % and prenatal checkup appointments remain below % among the syrian refugee population in turkey [ , ] . timely response strategies remain an urgent priority [ ] . the unhcr continues to strengthen its response to covid- in refugee settlements by establishing isolation and treatment centers (itcs), scaling hygiene promotion, and reforming water and sanitation delivery. however, as the number of covid- cases among refugee populations continues to grow, collective action and cooperation are required to ensure prompt recognition, treatment, and communication among communities to limit further spread [ ] . in this report, we explore the potential for a novel digital health platform to complement these large scale supply-side efforts to improve healthcare access for doubly vulnerable displaced populations. certain precautionary measures have been recommended to limit the spread of covid- : hand hygiene, facemasks, social distancing, self-isolation, and adequate nutrition. however, these measures are often not possible for the . million syrian refugees in neighboring countries, or displaced persons living under difficult conditions globally. it is important to understand and consider these unique needs in both the planning and execution of a comprehensive covid- response, with particular attention to preparedness, surveillance, and communication plans. preventing infection is the best way to protect both refugee and host communities; however, there is little evidence on how to best do this for those affected by a humanitarian crisis, during a global pandemic from an emerging disease. directed research on agile interventions is crucial to better understand target areas for scale during rapidly evolving crises. unlike in prior epidemics, the overwhelming majority of reported deaths from covid- have been in higher income countries (hics) [ ] . while these countries appear to have been affected by covid- earlier due to social mobility, the virus quickly spread worldwide to include outbreaks in low-and middle-income countries (lmics). while hics have struggled to manage the pandemic, lmics face potentially devastating morbidity and mortality, given their relative lack of resources and context-specific interventions [ ] . demographic differences across these contexts can be significant enough to affect population-level behavior and epidemiology. for example, the population of syrian refugees in and around istanbul alone is estimated to be one million, with % under , and % female; this is younger than the local population in the same regions [ ]. thus, a mobile health application targeted towards a younger and female demographic could provide an important modality for public health interventions. information and communication technology infrastructure has grown substantially over the past two decades worldwide, and particularly in lmics over recent years [ ] . communicating and collecting data with innovative and user-friendly mobile technologies could serve as an important tool for accessing displaced and other highly mobile populations. such a tool could also serve to empower this population by increasing control over their own health. evidence on the sustainability of mhealth implementation in traditionally resource-constrained environments is limited but continues to grow [ , , , , ] . positive long-term impact of mhealth in lmics has been demonstrated with chronic disease management [ ] , including behavior change [ ] , and medication adherence [ ] . in particular, mobile technology has been an effective tool to reduce the burden of disease through more efficient prevention, treatment, education, data collection, and management support in hiv/aids and tuberculosis care [ ] . in complex humanitarian emergencies, improved surveillance and monitoring with mhealth applications has been shown, with examples including the west african ebola outbreak, the haitian earthquake, and the cholera outbreak [ , , ] . while successful mhealth innovations exist in humanitarian contexts globally, quality evidence is overall limited and requires ongoing contextualization of local needs. the hera app is an open-source mobile application specifically designed for the syrian refugee population in turkey [ ] . it was created in to harness the high levels of smartphone usage among the syrian refugee community in turkey to improve access to healthcare. the mobile application enables users to safely and privately receive healthcare appointment reminders, access healthrelated communication, store medical records, contact emergency services, and navigate the turkish healthcare system in the three most commonly spoken local languages: arabic, turkish, and english [ ] . a feasibility pilot study of syrian refugee women in istanbul who were either pregnant or had at least one child under the age of two was conducted in with the hera app. it found that automated reminders for antenatal visits and childhood immunizations were effective in improving compliance, were positively received, and can be a low-cost, high-value alternative to other reminder methods [ , ] . importantly, the study confirmed that these women had access to smartphones and that they use them as a method of accessing health information. in response to the evolving covid- pandemic, the hera app was modified to include a covid- response component in march of . hera app was chosen as it was already in use and shown to be a feasible method of mobile communication by the target population. the education content was adapted to include general information about covid- , including basic protective measures, a virus tracking map, government restrictions, and testing site referrals. users were notified about these updates on their mobile devices. this intervention was performed in a primarily urban setting with syrian refugees who live in and around istanbul, turkey, focusing on women, under a previously obtained ethics review board approval from acibadem university. following the initial incorporation of these educational features to the hera app, % (n = ) of the user-base was successfully contacted for symptomatic assessment at two-week intervals. novel mhealth applications can enable broad use of innovative end-user centered interventions for highly mobile populations during a pandemic response. within this context, they can be used to: ) widely disseminate health information for refugees, ) identify and educate highrisk mobile populations to ensure proactive screening and early case identification, ) support data collection of mobile populations during infectious outbreaks, and ) decompress hospital-based triage by improving access to health information and safety planning. mhealth tools can be a low-cost and agile method to rapidly adapt and scale both individual and populationlevel health interventions. in our example, uptake of the hera app in turkey was rapid, and users received education on preventing the spread of covid- while completing regular covid- symptomatic self-assessments. this approach can be broadened to include additional health interventions, including increased education, contact-tracing, and triage support for overstretched public services. as infectious disease outbreaks exacerbate pre-existing health disparities, particularly among maternal, child, and refugee health, mhealth can be used to increase access to education and outreach for these doubly vulnerable populations [ ] . in lower-resourced regions with poor access to health care, where access to a cell phone is often easier than soap, mhealth can play an important role in beginning to close the disparity gap [ ] . mobile health platforms can serve as a key policy innovation for future outbreaks and other urgent global needs for diverse and moving populations in humanitarian crises. this mhealth intervention is uniquely designed to provide focused behavioral influence to increase the uptake of available public health services. the platform utilized an agile methodology framework with an iterative improvement process, allowing for meaningful incorporation of user-identified feedback on application features. importantly, it was initially designed not only as a medical tool but also to facilitate female empowerment and to encourage independent learning. this targeted education promotes the involvement of syrian women in the decision-making process about the family's health. building capacity for health literacy within a population historically susceptible to poverty and gender inequality is a stepping-stone in achieving health as a human right [ ] . mhealth interventions propose a unique, value-based opportunity to communicate with moving populations, as users do not need to carry anything other than a phone, and may provide affordable alternatives for information dissemination and health behavior change. when scaled, interventions such as this may allow for accurate symptomatic tracking, health education outreach, and triage offloading with minimal personnel and financial resource input, in order to reduce exposure risks within the health system. the data collection capacity allows for timely policy responses and subsequent cost-effective interventions for mobile populations. this was an exploratory evaluation of a modification to an mhealth platform, and the findings are limited by small sample size and lack of a control group. baseline data for population size, clinic appointment compliance, and vaccination status is difficult to assess, given the high mobility of the population. only self-assessment of the presence or absence of covid- symptoms was performed, and covid- infection incidence by laboratory testing among participants was not assessed. disparities in access to health care and health information by refugees are heightened during infectious disease outbreaks. mobile technology can play an important role in accessing and communicating with otherwise difficult to reach highly mobile populations, such as syrian refugees in turkey. the hera app is an example of an mhealth platform that can be rapidly distributed at low cost to improve access to care and information dissemination. additionally, similar mhealth applications can be rapidly adapted to emerging challenges, including the covid- pandemic. future research should evaluate the feasibility of mhealth platforms such as this in similar high-risk and difficult to reach populations, as well as evaluate their impact on targeted health behavior change and patientcentered outcomes. environmental refugees: an emergent security issue agile application of digital health interventions during the covid- refugee response art. , page of . situation syria regional refugee response. data . unhcr.org including forced displacement in the sdgs: a new refugee indicator -unhcr blog health care services in İstanbul for distancing is impossible': refugee camps race to avert coronavirus catastrophe treatment gap and mental health service use among syrian refugees in sultanbeyli, istanbul: a cross-sectional survey health needs and access to health care: the case of syrian refugees in turkey initiating research with doubly vulnerable populations unprepared for the worst: world's most vulnerable brace for virus global patterns of mortality in international migrants: a systematic review and meta-analysis treating syrian refugees with diabetes and hypertension in shatila refugee camp, lebanon: médecins sans frontières model of care and treatment outcomes who supports turkey to ensure full immunization of refugee children migration and health: experience of turkey clinical characteristics and pregnancy outcomes of syrian refugees: a case-control study in a tertiary care hospital in istanbul, turkey public health response in rohingya refugee settlements on alert as first coronavirus case confirmed has covid- subverted global health short message service (sms) applications for disease prevention in developing countries mobile health use in low-and high-income countries: an overview of the peer-reviewed literature telemental health in low-and middle-income countries: a systematic review the impact of mhealth interventions: systematic review of systematic reviews health worker mhealth utilization: a systematic review effectiveness of mhealth interventions for maternal, newborn and child health in low-and middle-income countries: systematic review and meta-analysis an updated systematic review with a focus on hiv/ aids and tuberculosis long term management using mobile phones effectiveness of mhealth behavior change communication interventions in developing countries: a systematic review of the literature text message intervention designs to promote adherence to antiretroviral therapy (art): a meta-analysis of agile application of digital health interventions during the covid- refugee response art agile application of digital health interventions during the covid- annals of global health this is an open-access article distributed under the terms of the creative commons attribution . international license (cc-by . ), which permits unrestricted use, distribution, and reproduction in any medium improved response to disasters and outbreaks by tracking population movements with mobile phone network data: a post-earthquake geospatial study in haiti tracking health seeking behavior during an ebola outbreak via mobile phones and sms. npj digital medicine evaluating the use of cell phone messaging for community ebola syndromic surveillance in high risked settings in southern sierra leone. african health sciences hera health recording app. hera project -medak lecture presented at: th annual state of global health symposium: global health and technology hera: a mobile health platform to improve syrian refugee maternal and child health in turkey -lessons learned. th annual consortium of universities for global health conference health inequalities and infectious disease epidemics: a challenge for global health security world health organization. mhealth: new horizons for health through mobile technologies gender equality and poverty are intrinsically linked: a contribution to the continued monitoring of selected sustainable development goals. united nations entity for gender equality and the empowerment of women (un women) we would like to thank rıfat atun (harvard school of public health) and nitika pai (mcgill university) for their role in conceptual contributions to hera, and berktuğ kubuk and pınar ercelik for their important contributions in field implementation. the authors have no monetary conflicts of interest relevant to this article to disclose. a.s. and n.n. are founders of hera inc., a non-profit that created the hera app, the described open source mhealth intervention. neither receives funding or compensation for this role. this paper underwent peer review using the cross-publisher covid- rapid review initiative. key: cord- - at qx authors: bielicki, julia a; duval, xavier; gobat, nina; goossens, herman; koopmans, marion; tacconelli, evelina; van der werf, sylvie title: monitoring approaches for health-care workers during the covid- pandemic date: - - journal: lancet infect dis doi: . /s - ( ) - sha: doc_id: cord_uid: at qx health-care workers are crucial to any health-care system. during the ongoing covid- pandemic, health-care workers are at a substantially increased risk of becoming infected with severe acute respiratory syndrome coronavirus (sars-cov- ) and could come to considerable harm as a result. depending on the phase of the pandemic, patients with covid- might not be the main source of sars-cov- infection and health-care workers could be exposed to atypical patients, infected family members, contacts, and colleagues, or live in communities of active transmission. clear strategies to support and appropriately manage exposed and infected health-care workers are essential to ensure effective staff management and to engender trust in the workplace. these management strategies should focus on risk stratification, suitable clinical monitoring, low-threshold access to diagnostics, and decision making about removal from and return to work. policy makers need to support health-care facilities in interpreting guidance during a pandemic that will probably be characterised by fluctuating local incidence of sars-cov- to mitigate the impact of this pandemic on their workforce. an adequate level of staffing is crucial to maintain patient care during the ongoing covid- pandemic. frontline health-care staff assess and manage patients with covid- , patients presenting with emergencies not related to covid- , and patients with essential routine care needs. one of the greatest risks to the health-care system is a high rate of severe acute respiratory syndrome coronavirus (sars-cov- ) infection among health-care workers and the consequent lack of skilled staff to ensure a functioning local or regional response to the pandemic. this risk has been increased by the need for rapid scaling up of intensive care unit (icu) capacity in affected regions, the redeployment of clinical staff to frontline positions (eg, icus or covid- wards), and the recruitment of less experienced staff (eg, newly qualified students or health-care staff moving from their specialism) to the workforce in response to the pandemic. , health-care workers could acquire sars-cov- at work through direct or indirect contact with infected patients or other health-care workers, or as a result of ongoing community transmission. community transmission of sars-cov- is targeted by public health measures, whereas infection by patient or health-care worker contact is primarily addressed by facility-based infection prevention and control (ipc) measures. however, sources of infection might not be clear and this uncertainty can have negative effects on the clinical workforce. ipc measures are extensive in hospitals managing patients infected with sars-cov- and, broadly speaking, include rigorous cleaning and dis infection to reduce environmental contamination and the use of personal protective equipment (ppe), isolation, and cohorting. national and international recommendations for risk assessment and management of hospital health-care staff working with patients infected with sars-cov- are detailed and publicly available. [ ] [ ] [ ] [ ] however, recommendations might not be easily transferrable because health-care systems are highly variable in terms of their structure and workforce composition. available guidance can become rapidly unsuitable when the situation at the frontline of health-care delivery is continuously changing. therefore broad recommendations need to be translated into locally applicable and pragmatic solutions. in this personal view, we outline and discuss possible approaches to inform develop ment of local policy related to health-care worker exposure and management during the covid- pandemic. several emerging viral diseases are known to have had a major effect on health-care workers, which is currently being observed also with sars-cov- . , in an early case series from wuhan, china, % of patients with sars-cov- were health-care workers and were assumed to have acquired the infection in hospital. deaths among health-care workers infected with sars-cov- are rare and have mostly affected those older than years. , tragically, health-care workers rehired from retirement to help at the frontline have commonly experienced the highest mortality when compared with their working-age counterparts. , with an increasing understanding of the disease, the proportion of healthcare workers contracting covid- in hospital has decreased, but stringent ipc measures and continued vigilance are needed. the risk profile for sars-cov- exposure and infection among health-care workers differs substantially from other groups. in designated covid- wards or hospitals, health-care workers are at high risk of infection. potential exposure to sars-cov- is inherent to their work and is prevented only by excellent adherence to all ipc measures, including the use of appropriate ppe. there is uncertainty about what is optimal ppe, but it is clear that standardised and rigorous application of ppe and other ipc measures can dramatically reduce nosocomial transmissions. , personal view health-care workers are likely to be in contact with patients and colleagues who have atypical, few, or no symptoms while still being highly contagious. [ ] [ ] [ ] a high proportion of such individuals will be present in the hospital, including in areas with insufficient awareness or identified need of ipc measures, as the virus spreads (figure). particular attention is needed for health-care workers looking after patients who are highly dependent and live in long-term care facilities, which may be built to resemble home-like environments, compro mising the ability to apply stringent ppe and other ipc measures. similarly, the presence of oligosymptomatic health-care workers infected with sars-cov- in situations during which ppe is not usually applied, such as scheduled meetings, grand rounds, educational events, and break times, will become more likely as the pandemic progresses. finally, with increasing community transmission, the highest risk of sars-cov- exposure for health-care workers could be outside of the hospital. many health-care workers will contract sars-cov- through interactions with infected family members or other close contacts, or from the community in areas with active, unmitigated transmission. , improper ppe use, suboptimal adherence to ipc measures, and having a family member with covid- can double or triple the risk of subsequent health-care worker sars-cov- infection. a detailed study of the prevalence of sars-cov- among mildly symptomatic health-care workers in dutch hospitals shows that many infections were most likely acquired in the community. , defining the risk of a health-care worker being infected with sars-cov- can be the first step towards selecting the most appropriate monitoring and evaluation approach. , , , , risk categories for in-hospital exposures are frequently based on the type of contact that has taken place and whether ppe was used consistently and appropriately. additional specifications are sometimes included in risk assessment algorithms-eg, presence during aerosol-generating procedures or exact distancing from patients with covid- (usually closer or further than m). , focusing on adherence to ppe implies that the optimal ppe for all potential contact situations is known and available. however, the effect of optimal ppe and other ipc measures is being debated because robust evidence to match ppe and ipc interventions to the risk profile of a given exposure is scarce. [ ] [ ] [ ] exposures to sars-cov- via community cases and infected colleagues can be frequent depending on the phase of the outbreak. risk assessment of health-care worker exposure, in our opinion, is going to be most useful in epidemic phases with low rates of community transmission. in all other situations, all health-care workers should be considered at moderate to high risk of contracting sars-cov- , especially when extended ipc measures, including some use of ppe, cannot be implemented for all patient contacts and staff interactions. data showing that viral shedding and potential sars-cov- trans mission could occur - days before symptom onset highlight the importance of wearing adequate ppe in hospitals during phases of high sars-cov- incidence. therefore, risk-appropriate ppe and optimal adherence to ipc measures will reduce the risk of health-care worker infection to that encountered in the community. guidance provided by peking union medical college hospital (beijing, china) suggests that all health-care workers in close contact with patients with covid- , regardless of ppe use, should undergo nasopharyngeal and oropharyngeal pcr testing and a full blood count after an unspecified block period of work in the designated area. further management decisions are determined by the results of these tests but, if negative, health-care workers are monitored for week and could resume work after this time if asymptomatic. calls have been made by health-care workers to improve availability of testing for asymptomatic healthcare staff and allow screening. in our opinion, this approach has the distinct disadvantage of requiring very frequent evaluation, given that intermittent testing might not capture asymptomatic sars-cov- positive individuals. for example, in a case series of patients with asymptomatic sars-cov- infection, eight were rt-pcr negative up to days after first identification of sars-cov- and could well have been missed by fortnightly screening. we therefore do not favour regular general sars-cov- testing of health-care workers by pcr as an effective monitoring approach. an alternative to intermittent pcr testing is to adopt a responsive approach to moni toring health-care workers. most national monitoring systems incorporate some form of daily (self)screening for fever and assessment of respiratory symptoms. , , , , stringent documentation and reporting requirements are an additional burden on health-care workers who are already stretched by the demands of patient care. active symptom monitoring by public health authorities or their delegates of healthcare workers deemed at risk of sars-cov- infection in occupational health is not feasible once an epidemic is in the exponential phase. self-monitoring and reporting are more feasible but must be combined with excellent communication from occupational health officers to ensure that health-care workers feel adequately supported and have a point of contact to discuss any concerns or questions. very low threshold access to occupational health to report any feelings of illness is crucial. health-care workers might be concerned about whether such symptoms could indicate sars-cov- infection and might be reluctant to report mild symptoms because they feel that they are burdening the system. furthermore, even mild symptoms can be indicative of sars-cov- infection, as shown when enhanced access (whereby all people with any respiratory symptoms or generalised symptoms suggestive of an infection are invited for testing) to testing was made available at a group of hospitals in the netherlands. direct access to occupational health has the additional advantage of enabling some psychosocial screening of the effect of working during the covid- pandemic. testing should be made available widely to symptomatic health-care workers and auxiliary acute health-care staff. the importance of supporting health-care worker access to sars-cov- testing in the case of symptoms cannot be overemphasised, particularly when the source of infection shifts from individual patients who are clearly identifiable to widespread viral transmission. interactions with colleagues who are also at increased risk of exposure and infection could become classed as high-risk pro cedures. during the period of unmitigated community transmission in the uk, access to testing for health-care workers, including those with symptoms, could not be guaranteed at a time when the medical workforce was under severe pressure from soaring sars-cov- cases. after roll-out in a single uk national health service trust, % of symptomatic staff tested positive for sars-cov- in the first weeks of the test being available, showing that there is potentially a large pool of infected individuals working in hospitals in a setting with sustained commu nity transmission. many countries prioritise health-care workers for sars-cov- testing, often on the basis of reported sympt oms and regardless of a confirmed exposure. for example, switzerland and the netherlands recommend rapid access to sars-cov- pcr testing and results for health-care workers because this information is used for decision making about deployment of medical staff. , personal view decision making on health-care worker removal from and return to work the most suitable approach towards managing removal from and return to work of health-care workers depends on the pursued public health strategy (ie, containment or mitigation) and the current pressures on the health-care system. during containment, standard quarantine and isolation should also be applied to health-care workers given that a special provision for health-care workers is unlikely to be necessary or helpful. premature redeployment of quarantined or isolated health-care workers will probably be needed only in exceptional cases-eg, for highly specialised staff. when testing of all symptomatic individuals cannot be guaranteed, as is often the case in a mitigation phase, pcr testing of symptomatic health-care workers should be prioritised and can be used to reduce workforce depletion caused by quarantine and isolation of sympto matic health-care workers. the pressures on a given health-care system are considerable; however, it is difficult to justify a special status for health-care workers from a public health perspective because of the bidirectional nature of sars-cov- infections among this group. although health-care workers can acquire sars-cov- at work, introducing transmission into the community, they may also bring sars-cov- into the hospital following community exposures. pcr testing of asymptomatic quarantined health-care workers will provide false reassurance for exposed indi viduals with early negative results who go on to develop disease later on in the defined quarantine period. the role of pcr testing is different for symptomatic individuals. home isolation periods range from a minimum of days (under certain conditions) in france and the uk, to days in germany and italy, and isolation is often recommended independently of whether sars-cov- has been identified by testing. in most cases, an additional requirement of at least h without symptoms before ending isolation is also specified. in the netherlands, infected health-care workers who are considered crucial for the care of patients with covid- can return to work after h without symptoms, so shorter isolation periods are concei vable. , , , , , pcr testing of health-care workers should be used to ensure that isolation of symptomatic staff is limited to individuals who have been confirmed as sars-cov- positive. , in some cases, pcr testing is recommended to support rapid return to work of infected health-care workers if they become negative on pcr before the isolation period has elapsed. for example, german guidance recommends that health-care workers who required hospital treatment can return to work immediately if two pcr tests at least h apart are negative. , in switzerland, re-testing of health-care workers infected with sars-cov- at the end of the isolation period is proposed for those working in high-risk areas (haemato-oncology, icus, transplant units) and those with prolonged disease. there is considerable uncertainty about the relevance of prolonged detection of sars-cov- on pcr testing for transmissibility; therefore, the role of repeat testing to determine redeployment of health-care workers after sars-cov- infection is unclear. for health-care workers with confirmed sars-cov- infection, testing at the end of the isolation period is sometimes used to confirm suitability for return to work, often with two pcr tests at least h apart. , however, in practice, these recommendations are problematic. a study comparing rt-pcr testing and virus culture found that patients with mild symptoms were positive by rt-pcr for up to days, whereas no infectious virus could be recovered after day post illness onset. therefore, a symptom-based algorithm that informs when isolated health-care workers should return to work appears to be best when exposed or infected health-care workers are considered crucial to service maintenance and extended periods of quarantine or isolation are not feasible. studies are ongoing to assess the possible role of serology as a marker for viral clearance in people with mild illness. the exact algorithm for managing exposed and infected health-care workers should aim to safeguard staff wellbeing and reduce onwards transmissions to colleagues and patients without undermining the ability to maintain an adequate service, which is often a difficult balance. the exact configuration of the health-care setting and ipc strategies will affect the success of the management strategy and might require different approaches during different phases of the pandemic, especially when the use of ppe and sources of health-care worker infection are shifting (table) . with proper use of ppe and good adherence to ipc measures, the risk of sars-cov- infection of health-care workers caring for patients with covid- is considered to be very low. physical distancing should be encouraged for contact with colleagues, such as during meetings, joint meals, and in office spaces. monitoring and identifying health-care workers with symptoms compatible with or suggestive of sars-cov- infection is essential to ensure appropriate triaging of staff for duty, further evaluation, and follow-up. there are considerable psychological and social strains on health-care workers because they work in a highly stressful and demanding environment and could have negative psychological effects caused by concerns over ppe availability; therefore, monitoring policies should con sider how to incorporate the rapid assessment of psychosocial needs of health-care workers. rapid and low-threshold access to sars-cov- testing and results for health-care workers are key to maintaining personal view an adequate workforce. regular screening of health-care workers by pcr is unlikely to be an effective means of workforce management until evidence-based algorithms to define target staff and frequency of testing are developed, and even then negative tests might offer a false sense of reassurance. clear algorithms must exist can identify hcws at considerable risk of acquiring sars-cov- in the health-care setting and focus resources on active monitoring or proactive laboratory testing; can support implementation of quarantine measures for a specific group of hcws, minimising the effect on the workforce and maximising containment of sars-cov- within the health-care environment can reduce awareness that interactions with any patients with covid- (known or unknown) carry some risk of nosocomial transmission to hcws; can be confusing when understanding of the optimal ppe remains unclear; can undermine hcw engagement with key ipc measures other than ppe (eg, hand hygiene and physical distancing) in the erroneous belief that these are ineffective; might not be relevant in settings where some level of ppe is universally recommended (eg, wearing of surgical masks for all patient contacts) and there is high adherence to other ipc measures use of (self)quarantine after contact can maximise containment of sars-cov- within the health-care environment, especially in hcws who may have no, few, or atypical symptoms; can reduce hcw anxiety about contracting sars-cov- in the workplace from colleagues with known exposure can rapidly deplete the workforce, particularly in cases of hcws infected with sars-cov- exposing many colleagues or when there is uncontrolled community transmission, with hcws exposed outside of the hospital; might not be relevant in settings where some level of ppe is universally recommended (eg, wearing surgical mask for all patient contacts) and there is high adherence to other ipc measures active (eg, at the start of shifts or through regular telephone or email reporting) can support the reliable reporting of signs and symptoms compatible with sars-cov- infection; can lead to earlier identification of symptomatic hcws, and therefore support targeted timely testing to reduce exposure of colleagues and patients; can be an opportunity to interact with hcws about their general psychological and physical wellbeing to provide wider support can present a considerable administrative and resource challenge, depending on the exact method of active monitoring and selection of hcws who undergo active monitoring; can lead to a rapid depletion of staff if minor symptoms lead to (self)isolation without sars-cov- testing; might be a drain on resources, especially in cases of clusters involving multiple hcws and in settings where large sections of a hospital are dedicated to the care of patients with covid- self-monitoring can reduce the barrier to hcw sars-cov- testing, if a simple algorithm is combined with clear advice on how to access testing; can involve the majority of hcws in one facility, thereby detecting sars-cov- cases among personnel resulting from known and unknown exposures within and outside of the health-care setting; can be supported using digital tools, such as symptom monitoring apps can support rapid identification of hcws infected by sars-cov- to provide adequate clinical support and inform self-isolation; can provide a sense of security to staff working in close proximity with colleagues (eg, icus, operating theatres, emergency departments); can represent an efficient use of resources, especially if the threshold for accessing testing is low, sampling is carried out rapidly after onset of symptoms, and results are available in a timely fashion can lead to delays in identification of symptomatic sars-cov- positive hcws by relying on (self-) identification of symptoms if pathways to accessing testing are unclear or cumbersome, or if hcws feel uncomfortable with accessing testing because of fear or stigma; might not identify asymptomatic or oligosymptomatic sars-cov- positive hcws who could theoretically represent a source of infection for other staff or patients can prevent a difficult to justify disconnect between public health measures and special provisions for hcws; could ensure that the risk of introduction of sars-cov- from the health-care setting to the community is minimised for handling the possible scenarios from testing of sympto matic health-care workers, in principle those who are sars-cov- negative and those who are sars-cov- positive with or without clinical illness. these algorithms need to detail the exact pathway to inform return to work and include advice and support for household contacts of health-care workers who are sars-cov- positive. one logical consequence of offering testing to symptomatic health-care workers is to support rapid return to work of those who are sars-cov- negative and clinically able to work. when adequate staffing cannot be maintained and rapid redeployment of sars-cov- infected health-care workers is necessary, re-testing could identify health-care workers no longer shedding the virus, but the relevance of ongoing shedding is unclear. the roles of serological testing and prophylaxis (responsive or long term) for health-care workers remain to be defined. it is hoped that evidence of previous infection will correlate with the presence of neutralising antibodies and could identify health-care workers at a low risk of reinfection for voluntary supported deployment in covid- wards. trials of (chemo)prophylaxis for health-care workers have started recruitment in various countries-eg, covidaxis in france (nct ) and bcg-corona in the netherlands (nct )but are not expected to report for some time. specific recommendations for monitoring health-care workers for potential sars-cov- infection should be available for all staff who are expecting to see or currently managing patients with covid- . we feel that in a strict containment phase with low levels of community circulation, management strategies should closely align with those defined for exposed and infected members of the general public, meaning that quarantine and isolation will be stringently applied. given that out breaks put excess pressure on the health-care system, special provisions for health-care workers are unlikely to be needed or justifiable. however, beyond this stage, algorithms for accelerated redeployment of mildly symptomatic health-care workers might be necessary to safeguard adequate staffing levels for patient care, and a very low threshold for access to testing should be instituted to support this. clearly, health-care workers returning to work must prioritise their clinical and psychological wellbeing and consequent ability to reenter the workspace. on the whole, health-care staff have been observed to be extremely dedicated to ensure that their patients are adequately cared for under very difficult circumstances. supporting health-care workers in selfmonitoring and self-care, providing them with easy access to diagnostics and medical and psychosocial support, and offering clear guidance for safe and timely transitioning back to work will strengthen patient care as a whole and could ultimately improve outcomes for many patients and health-care workers. all authors contributed to the concept of the manuscript and identified relevant data. jab wrote the first draft of the manuscript, which was critically revised and approved by all authors. we declare no competing interests. covid- and italy: what next? the art of war" in the era of coronavirus disease (covid- ) intensive care during the coronavirus epidemic intensive care management of coronavirus disease (covid- ): challenges and recommendations escalating infection control response to the rapidly evolving epidemiology of the coronavirus disease (covid- ) due to sars-cov- in hong kong contact tracing: public health management of persons, including healthcare workers, having had contact with covid- 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switzerland uitgangspunten inzetten en testen zorgmedewerkers optionen zum management von kontaktpersonen unter medizinischem personal (auch bei personalmangel) in arztpraxen und krankenhäusern) covid- : kriterien zur entlassung aus dem krankenhaus bzw aus der häuslichen isolierung virological assessment of hospitalized patients with covid- this manuscript is part of the output from recover (rapid european covid- emergency research response), which has received funding from the eu horizon research and innovation programme (grant agreement number ). the funder had no role in the writing of the manuscript or the decision to submit for publication. the views and opinions expressed in this personal view are those of the authors. key: cord- - a djjm authors: benke, christoph; autenrieth, lara k.; asselmann, eva; pané-farré, christiane a. title: lockdown, quarantine measures, and social distancing: associations with depression, anxiety and distress at the beginning of the covid- pandemic among adults from germany date: - - journal: psychiatry res doi: . /j.psychres. . sha: doc_id: cord_uid: a djjm the covid- pandemic is suggested to have a negative impact on mental health. to prevent the spread of sars-cov- , governments worldwide have implemented different forms of public health measures ranging from physical distancing recommendations to stay-at-home orders, which have disrupted individuals’ everyday life tremendously. however, evidence on the associations of the covid- pandemic and public health measures with mental health are limited so far. in this study, we investigated the role of sociodemographic and covid- related factors for immediate mental health consequences in a nationwide community sample of adults from germany (n = ). specifically, we examined the effects of different forms and levels of restriction resulting from public health measures (e.g. quarantine, stay-at-home order) on anxiety and depression symptomatology, health anxiety, loneliness, the occurrence of fearful spells, psychosocial distress and life-satisfaction. we found that higher restrictions due to lockdown measures, a greater reduction of social contacts and greater perceived changes in life were associated with higher mental health impairments. importantly, a subjectively assumed but not an officially announced stay-at-home order was associated with poorer mental health. our findings underscore the importance of adequate risk communication and targeted mental health recommendations especially for vulnerable groups during these challenging times. the coronavirus disease has recently evolved into a global crisis affecting the physical and mental health of people worldwide. due to the rapid dissemination of the sars-cov- virus and its potential deleterious effects for physical health, governments worldwide have imposed different forms and levels of public health measures ranging from physical distancing recommendations to stay-at-home orders to contain an uncontrolled spreading of the sars-cov- virus. although being effective in preventing a further dissemination of the coronavirus (nussbaumer-streit et al., ) , these measures may have changed peoples" everyday life significantly and may have led to an immediate disruption of self-regulated behavior and a reduction of social connections (e.g. loss of reinforcer and social support, perceived controllability) which may lead to specific mental health problems, especially in vulnerable people (lewinsohn and atwood, ; brooks et al., ; holmes et al., ) . moreover, people are faced with the risk of a potentially life-threatening covid- infection, which may trigger feelings of uncertainty, fear, anxiety and even result into social isolation (asmundson and taylor, ; mertens et al., ) . a few previous studies from different countries worldwide investigated the role of sociodemographic and covid- related factors for mental health (gonzález-sanguino et al., ; losada-baltar et al., ; pierce et al., ; tull et al., ; wang et al., ; see luo et al., ; vindegaard and eriksen benros, for a review). their findings suggest that especially women, younger people, as well as individuals with a mental disorder, chronic somatic disease, and predisposing factors for a potentially severe course of covid- are at risk for mental health problems during these challenging times. however, studies on the effects of different forms and levels of restrictions resulting from public health measures (e.g., stay-at-home orders, being quarantined or reduction of social contacts) on mental health are scarce. studies from previous epidemics and the current covid- pandemic investigated the role of quarantine and related measures for mental health. some of these studies revealed that quarantine was associated with elevated mental health problems (wang et al. b; liu et al. ; wu et al. ; bai et al. ). however, these findings were not entirely conclusive, given that other research did not find such associations (wang et al. ; zhu et al. ; wang et al. a; zhang et al. ) . consequently, to adequately inform the public health care system and enable adequate measures to protect from or mitigate adverse mental health effects, the consequences and relevant factors influencing the psychological response to the pandemic and public health measures need to be characterized. in germany, daily infection rates rapidly increased early in march . at that time, each federal state started to implement public health measures (e.g., closure of schools and kindergartens) to prevent a further spread of covid- . although various measures were implemented all over germany, some measures (e.g. stay-home orders) and the associated degree of restriction for individuals" personal and social life differed between german federal states. the present study was conducted four weeks after all german federal states had implemented public health measures (e.g., minimum distance of . m to other persons, closure of non-essential shops, such as bookstores, warehouses; see steinmetz et al., ) . at the time of the study, the highest rate of covid- related death per day in germany was recorded since the outbreak of covid- in germany. the present study was aimed at identifying potential predictors for immediate mental health consequences to the covid- pandemic and related public health measures in germany. between th april and th may , a cross-sectional study was conducted among adults ( . % women and . % men) from all federal states of germany. participants were aged between and years (m= . years, sd= . years). the study started during the first peak of the corona crisis in germany (highest rate of covid- related deaths per day), four weeks after all german federal states had implemented public health measures. participants were recruited via convenience sampling methods (social media, personal contacts, e-mails, etc.) and completed an online survey (soscisurvey.de). all participants provided informed consent. the study was approved by the local ethics committee of the university of marburg. in addition to sociodemographic and covid- -related variables (see table for an overview), we assessed the following variables related to implemented public health measures: perceived changes in life due to public health measures: participants were asked to rate how much their everyday life had changed due to governmental measures that were taken to contain covid- spreading on a -point likert-scale (ranging from "not at all" to "very strong") and whether they perceived these changes as positive, neutral, or negative. social distancing: participants were asked to indicate how frequently they currently engage in social contacts with reference to january (prior to covid- outbreak in germany; converted scale: much less, less, unchanged) and whether they are distressed ( -point likert-scale ranging from not stressful at all to extremely stressful) by the restriction of social contacts. restrictions due to public health measures: forms of restriction measures that have been suggested to disrupt self-regulated and psychologically relevant behavior of individuals (steinmetz et al., ) were systematically recorded for each of the german federal states on a day by day basis (e.g., prohibition to meeting with others in public places, closure of kindergartens or daycare, prohibition to leave the apartment without reason) by the leibniz institute for psychology information (zpid, germany). each type of restriction was coded as not present (= ), partially (= ) or fully (= ) in place. for each public health measure, we determined the highest level of restriction (i.e., not present, partially or fully in place) within the period prior to the start of the survey. afterwards, the score of each measure was summed up to determine the overall level of personal and social restrictions resulting from public health measures in each federal state. stay-at-home-order: data provided by the zpid were also used to objectively determine which german federal state had announced a prohibition to leave the apartment without reason. perceived stay-at-home order: moreover, participants were asked to indicate whether they assumed that the government of their federal state had imposed a prohibition to leave the apartment without reason. this allowed us to delineate the effect of officially announced and subjectively perceived stay-at-home-orders on psychological outcome measures. the following psychological outcome measures were assessed: depressive symptoms were assessed with the patient health questionnaire- (phq- ; kroenke et al., ) . generalized anxiety was assessed with the -item generalized anxiety disorder scale (gad- ; spitzer et al., ; kroenke et al., ) , health anxiety with the short mental health during the covid- pandemic version of the whitely index (fink et al., ; hiller et al., ) , moreover, using the respective question of the dsm- cidi, participants were asked to indicate whether they had experienced a fearful spell during the last weeks. loneliness was assessed with the -item version of the ucla loneliness scale (russell, ) . psychosocial distress (e.g., due to financial problems or worries, distress at work, distress resulting from childcare, etc.) was assessed with the stress module of the patient health questionnaire. finally, and as in previous research (see lucas and donnellan, ) , general life satisfaction was assessed with a single item ("all things considered, how satisfied are you with your life these days?") and a -point likert-scale ranging from (completely dissatisfied) to (completely satisfied). statistical analyses were conducted with spss (spss for windows, ibm). analyses including data provided by the zpid (restrictions by public health measures and officially announced stay-at-home orders) were limited to those participants who reported their zip codes (n= ). first, linear regressions (adjusted for gender and age) were used to test associations of sociodemographic and covid- -related factors with psychological outcomes. second, all sociodemographic and covid- -related variables being significantly associated with outcomes were used as multiple predictors for outcome measures. the alpha level was set at . . in the present study, . % of the sample exceeded the cutoff score for a potential depression diagnosis (phq- ≥ ), . % exceeded the cutoff score for a potential anxiety disorder diagnosis (gad- ≥ ), . % exceeded the cutoff score for health anxiety (wi- ≥ ), . % reported to be lonely (loneliness ≥ ), . % of the sample reported mild psychosocial distress (phq stress module scores ranging between and ), while . % reported moderate to severe psychosocial distress (phq stress module ≥ ). . % of the sample reported having experienced a fearful spell during the last weeks. the mean score of life-satisfaction was . (sd = . ). associations between sociodemographic factors and psychological outcomes are presented in table . female sex, younger age, a lower educational level, being unemployed, being single, living alone, living without underage children and a current or past psychotherapeutic or psychiatric treatment were associated with higher depressive symptomatology. female sex, younger age, a lower educational level, being unemployed, living alone, as well as current or past psychotherapeutic or psychiatric treatment were associated with higher anxiety symptomatology. being unemployed or not working and current or past psychotherapeutic or psychiatric treatment was associated with higher health anxiety. younger age, lower educational level, being unemployed, living alone and current or past psychotherapeutic or psychiatric treatment were associated with higher loneliness. female sex, younger age, lower educational level, living together in a relationship, living with underage children and a current or past psychotherapeutic or psychiatric treatment were associated with higher psychosocial distress. female sex, older age, a higher educational level, being employed, cohabiting with a partner, cohabiting with children, no current or past psychotherapeutic or psychiatric treatment were associated with higher life-satisfaction. being in self-quarantine was associated with higher health anxiety and with fearful spells. however, being quarantined by a local health authority was not associated with any psychological outcome. belonging to an officially announced covid- risk group was associated with higher anxiety and depressive symptomatology, health anxiety, fearful spells, higher psychosocial distress, and lower life-satisfaction. having contact to loved ones that belong to an officially announced covid- risk group was associated with higher health anxiety and lower loneliness. having a confirmed diagnosis of covid- was associated with higher loneliness, while a confirmed diagnosis of covid- in loved ones was not associated with any outcome measure. a higher level of restriction due to public health measures was associated with higher loneliness, higher psychosocial distress, and lower life-satisfaction. a stronger reduction of social contacts, higher distress due to restrictions of social contacts, stronger perceived changes in life due to the public health measures and a more negative appraisal of these perceived changes were positively associated with higher anxiety and depressive symptomatology, fearful spells, psychosocial distress and lower life-satisfaction. there was no association (expect for social distancing related distress) of theses predictors with health anxiety. . % of the sample correctly reported that there was no officially announced stay-athome order in their federal state, while . % of the current sample correctly reported to live in a federal state in which government had announced a stay-at-home order. however, . % of the sample reported that there was an officially announced stay-at-home order in their federal state, despite the fact that there was no governmental imposed prohibition to leave the apartment without reasons. . % of the sample negated that the government has officially announced a stay-at-home order, while their federal state has officially announced a stay-at-home order. there was no association of officially announced stay-at-home orders with psychological outcome measures (see table ). however, perceived stay-at-home orders were associated with higher anxiety and depressive symptoms, fearful spells, higher psychosocial distress, higher loneliness, and lower life-satisfaction (see table ). perceived stay-at-home orders were unrelated to health anxiety. moreover, to test whether perceived stay-at-home orders interacted with officially announced stay-at-home orders in predicting scores on psychological outcome measures an interaction term was included in the regression analysis. the moderation analysis revealed that an officially announced stay-at-home order did not interact with the perceived stayat-home order in predicting mental health outcomes. that is, participants who believed that government had announced a stay-at-home order reported higher scores on psychological outcome measures whether or not government has officially announced stay-at-home orders in their federal state (officially announced x subjectively perceived stay-at-home order interaction, βs = -. -. , or = . , all ps > . ). moreover, negating a stay-at-home order despite the fact that government has announced a stay-at-home order was unrelated to our mental health outcomes (β = -. -. , or = . , all ps > . ). table summarizes the predictors that remained significantly related to the psychological outcomes in multiple regression models. a current or past psychiatric or psychotherapeutic treatment, belonging to a covid- risk group and perceived distress related to the restriction of social contacts were significant predictors in all models (see table for detailed information on all significant predictors for the respective outcome measure). the overall models significantly explained between . % and . % of variance in psychological outcome measures (see table ), all p-values < . . in early , governments worldwide started to implement different forms of public health measures ranging from physical distancing recommendations to stay-at-home orders to prevent further spreading of covid- . for the first time, this study investigated sociodemographic and covid- related factors and, specifically, the role of such different types of governmentally imposed lockdown measures for depressive and anxiety symptoms as well as other health outcomes across all federal states of germany. in the present sample, . % exceeded the cutoff score for a potential depression, . % exceeded the cutoff score for a potential anxiety disorder diagnosis and . % of the sample reported having had a fearful spell during the past weeks. these data are comparable to the prevalence reported in studies conducted in other countries during the covid- pandemic (luo et al., ) . consistent with previous studies from countries around the world (see luo et al., ; vindegaard and eriksen benros, for a review), we found that belonging to a risk group for a severe course of covid- , a current or past treatment due to mental health problems, being unemployed or nonworking, a lower educational level and younger age were associated with negative mental health consequences of the covid- public containment measures. moreover, we revealed that a stronger reduction of social contact, stronger perceived changes in life, and a perceived stay-athome order were associated with poorer mental health. in multiple regressions, common factors that remained significantly related to all outcome measures included a current or past treatment due to mental health problems, distress related to contact restriction and belonging to a risk group for a severe course of covid- . in the present study, we found that a higher level of restrictions due to lockdown measures was associated with more loneliness, higher psychosocial distress and lower life-satisfaction but was not related to anxiety and depressive symptomatology or fearful spells. although the level of restriction due to lockdown measures was not associated with an immediate increase in psychopathological symptoms, more loneliness and higher psychosocial distress might be relevant factors that facilitate or moderate potential negative consequences for mental health. especially loneliness has been associated with an increased risk for several mental disorders and somatic diseases in general (beutel et al. ; holt-lunstad et al. ; valtorta et al. ; luhmann und hawkley ) and during the current pandemic (palgi et al. ; gonzález-sanguino et al. ; luchetti et al. ) . for example, recent studies found that loneliness strongly predicted depressive and anxiety symptoms during covid- -related lockdown measures (palgi et al. ; gonzález-sanguino et al. ) . thus, reducing loneliness might be an important target for prevention programs in order to mitigate negative mental health consequences during these challenging times (holmes et al. ) . moreover, an officially announced stay-at-home order was not related to mental health outcomes. however, about one in four respondents reported to live in a german federal state in which government has imposed a prohibition to leave the apartment without sound reasons (stayat-home order), while objective data indicated that the respective government had not announced such stay-home-order. although there was a stay-at-home order, % of the sample negated that there was an officially imposed prohibition to leave the apartment in their federal state. in contrast to the officially announced stay-at-home order, a perceived stay-at-home order was associated with poorer mental health outcomes. the present findings extend preliminary results from a small cross-sectional study in the us (tull et al., ) in demonstrating that a perceived stay-at-home order was related to more severe depressive and anxiety symptomatology, greater reported loneliness, more fearful spells, greater psychosocial distress and lower life-satisfaction irrespective of whether a stay-at-home order was officially announced or not. importantly, those persons who were affected by a stay-at-home order but took no notice of this order showed no negative mental health consequences. the present finding indicates that misinformation about official stay-at-home orders might have a negative impact on mental health. for example, recent studies found that insufficient information (gonzález-sanguino et al. ) or misinformation ("fake news") on covid- (wang et al. b ) was associated with poorer mental health and well-being (ko et al. ; chao et al. ; gao et al. ) . in contrast, receiving information from health professionals or other experts was not associated with negative mental health consequences (ko et al. ; chao et al. ) . taken together, this suggests that appropriate risk communication during these challenging times of crisis is particularly crucial. thus, it seems important to announce timely, coordinated, transparent and definite instructions in plain language to all persons via official information channels to mitigate confusion, uncertainties, and misinformation regarding public health measures, to prevent negative mental health consequences. the present results should be considered in the light of the following limitations. in the present study, individuals of all ages ( - years) and from all german federal states were recruited. however, as a result of our recruitment method (i.e., convenience sampling methods) older respondents and men were relatively underrepresented in the current sample which limits the generalization of the present results to the general population of germany and other countries. our study exclusively relied on self-report data which might have been subject to memory and recall-biases. moreover, we only assessed internalizing symptoms like depressive or anxiety symptoms, while externalizing symptoms (e.g., anger, aggression, alcohol abuse) might also be affected by public health measures and restrictions (brooks et al., ) . the present study makes a significant contribution to the identification of potential risk groups and the impact of public health measures for immediate mental health consequences during the covid- pandemic. the current findings suggest that the covid- pandemic cause negative consequence for mental health especially in vulnerable groups (e.g. young adults, individuals with a mental disorder) which may need special attention and support by implementing interventions or prevention programs to mitigate long-term consequences for mental health (holmes et al., ) . moreover, in our study, there was little evidence that public health measures per se were associated with immediate mental health impairments. nonetheless, such measures might have unfavorable long-term effects on mental health. for example, lockdown measures have been associated with increased psychological distress and loneliness (tull et al. ) . in line with vulnerability-stress models, it is plausible to assume that such unfavorable feelings not necessarily relate to immediate mental health impairments, but may increase the risk to develop psychopathological symptoms and mental disorders in the future. most importantly, the present data indicate that people"s subjective perceptions of public health measures (i.e., the appraisal of perceived changes in life resulting from lockdown measures and the reduction of social contacts as negative or stressful) seem to be associated with increased psychopathological symptoms. this data underscores the need for appropriate risk communication to prevent insecurity, fear, and confusion and thus prevent negative mental health consequences. moreover, it might be helpful to develop and implement interventions or prevention programs including positive reappraisal or reframing and recommendations to maintain social contacts (e.g., via social media, video calls) in the face of physical distancing and contact restrictions to mitigate the negative effect of public health measures on mental health. . *** . *** . . ** . ** or: odds rations from logistic regressions; β: standardized beta coefficient; all logistic and linear regressions were adjusted for age and gender; ***p<. , **p<. , *p<. or: odds rations from logistic regressions; β: standardized beta coefficient; a nagelkerks r squared; ***p<. , **p<. , *p<. . coronaphobia: fear and the -ncov outbreak loneliness in the general population: prevalence, determinants and relations to mental health the psychological impact of quarantine and how to reduce it: rapid review of the evidence screening for somatization and hypochondriasis in primary care and neurological in-patients mental health consequences during the initial stage of the coronavirus pandemic (covid- ) in spain dimensional and categorical approaches to hypochondriasis multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science. the lancet psychiatry loneliness and social isolation as risk factors for mortality: a meta-analytic review the phq- : validity of a brief depression severity measure anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection depression: a clinical-research approach we're staying at home". association of selfperceptions of aging, personal and family resources and loneliness with psychological distress during the lock-down period of covid- . the journals of gerontology. series b, psychological sciences and social sciences estimating the reliability of single-item life satisfaction measures: results from four national panel studies the psychological and mental impact of coronavirus disease (covid- ) on medical staff and general public -a systematic review and metaanalysis fear of the coronavirus (covid- ): predictors in an online study quarantine alone or in combination with other public health measures to control covid- : a rapid review. the cochrane database of systematic reviews mental health before and during the covid- pandemic: a longitudinal probability sample survey of the uk population. the lancet psychiatry ucla loneliness scale (version ): reliability, validity, and factor structure a brief measure for assessing generalized anxiety disorder: the gad- the zpid lockdown measures dataset for germany psychological outcomes associated with stay-at-home orders and the perceived impact of covid- on daily life this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. the authors declare no conflict of interest. all authors report no financial relationships with commercial interests. -. * key: cord- -wt lt authors: kataria, ishu; ngongo, carrie; lim, shiang cheng; kocher, erica; kowal, paul; chandran, arunah; kual, aaron; khaw, fu-meng; mustapha, feisul idzwan title: development and evaluation of a digital, community-based intervention to reduce noncommunicable disease risk in a low-resource urban setting in malaysia: a research protocol date: - - journal: implement sci commun doi: . /s - - -y sha: doc_id: cord_uid: wt lt background: noncommunicable disease burden is rising in malaysia, accounting for % of all deaths. urbanization and globalization have contributed to changing patterns of diet and physical activity, creating an obesogenic environment that increases noncommunicable disease risk, especially in low-income populations. community-based and technological interventions can play an important role in addressing structural determinants that influence noncommunicable disease burden. the better health programme malaysia aims to co-create and develop a community-based digital intervention for low-income populations to enable community stakeholders to address obesogenic environments and improve people’s knowledge, attitudes, and practices related to noncommunicable disease risk. methods: this quasi-experimental study will assess community member and community health volunteer knowledge, attitudes, and practices on noncommunicable disease prevention, risk factors, and health-seeking behavior in three geographical areas of kuala lumpur, each representing a different ethnicity (malay, indian, and chinese). assessment will take place before and after a -month intervention period, comparing intervention areas with matched control geographies. we plan to engage community members and community health volunteers across the six geographic areas. a digital health needs assessment will inform modification of digital health tools to support project aims. intervention co-creation will use a discrete choice experiment to identify community preferences among evidence-based intervention options, building from data collected on community knowledge, attitudes, and practices. community health volunteers will work with local businesses and other stakeholders to effect change in obesogenic environments and ncd risk. the study has been approved by the malaysian ministry of health medical research ethical committee. discussion: the better health programme malaysia anticipates a bottom-up approach that relies on community health volunteers collaborating with local businesses to implement activities that address obesogenic environments and improve community knowledge, attitudes, and practices related to ncd risk. the planned co-creation process will determine which interventions will be most locally relevant, feasible, and needed. the effort aims to empower community members and community health volunteers to drive change that improves their own health and wellbeing. the learnings can be useful nationally and sub-nationally in malaysia, as well as across similar settings that are working with community stakeholders to reduce noncommunicable disease risk. trial registration: national medical research register, malaysia; nmrr- - - (iir); july , noncommunicable diseases (ncds) are the leading causes of mortality and morbidity in malaysia, consistent with global patterns of disease burden. in malaysia, ncds account for an estimated . % of deaths and . % of lost disability-adjusted life years (dalys) [ ] . in , . % of malaysian adults had raised blood glucose, . % had raised blood pressure, and . % were overweight or obese [ ] . global changes in patterns of diet and physical activity due to urbanization, increasingly sedentary modes of transportation and employment, and the rise of readily available, calorie-dense, and processed foods all contribute to the increasing burden of obesity and ncds [ , ] . working in parallel to individual health risks, the "obesogenic environment" encompasses the physical, economic, and social aspects of an environment that influence food intake and physical activity [ ] . an obesogenic environment acts as a structural determinant of health through the availability of built or natural space for physical activity and the affordability and accessibility of healthy food options. the shift toward urban population centers, where % of malaysians currently live, has accelerated the burden of ncds [ ] . the rising global burden of obesity is associated with economic development and urbanization, but the impact of these socio-economic factors is not consistent across income levels [ ] . obesity and risk of ncds are associated with low-income, low-education, and lowsocioeconomic status in low-and middle-income countries [ ] . as countries develop economically, the burden of obesity rises most among poorer populations [ ] . people of low socioeconomic status are often disproportionately affected by negative environmental factors, contributing to the changing patterns of disparities in ncd risk factors by income [ ] . poorer populations may have limited access to affordable and healthy foods in their neighborhoods. they may work long hours or multiple jobs, leaving limited time for physical activity. their neighborhoods may not include safe spaces for walking or other activities, a concern that can be particularly challenging in dense urban environments. in malaysia, the poorest % of the population (the b ) have the highest prevalence of inadequate consumption of fruits and vegetables, and the poorest % of the population have the highest level of physical inactivity [ ] . in a study of b women living in urban high-rise dwellings in kuala lumpur, heathy eating index scores were positively associated with income and negatively associated with an individual's frequency of eating outside of the home, suggesting the influence of an unhealthy surrounding food environment [ ] . due in part to these increased risks, diabetes is more prevalent among the b than other income groups in malaysia [ , ] . community-based programs have shown promise in addressing risk profiles and the obesogenic environment [ ] [ ] [ ] . these programs have the advantage of being tailored to specific context and needs, a feature that is essential to efforts to improve the obesogenic environment and alter health behaviors [ ] . malaysia has a strong tradition of community-based health programming. beginning in the s, community health volunteers (chvs) worked with the primary health care system to promote malaria prevention activities. the the better health programme in malaysia will employ a cocreation process with communities to select and prioritizing evidence-based approaches to reduce the obesogenic environment of the urban poor. research will inform the project approach, including a knowledge, attitudes, and practices (kap) survey, a digital needs assessment, and a discrete choice experiment. this work will expand the evidence base around community-driven health promotion by documenting a bottom-up approach in which communities define priorities and community health volunteers work alongside local businesses to address obesogenic environments. ( ) : program expanded its focus to health promotion and preventive activities more broadly [ ] . other programs have successfully relied on a community-based approach to address maternal and child health and communicable diseases [ ] . since the komuniti sihat pembina negara (kospen) program deployed a network of chvs to conduct ncd screening and health education on a range of ncd topics, including healthy eating, active lifestyle, body weight management, smoking, and regular health screening [ , ] . while the program is positively viewed by participating chvs, previous evaluations have identified important limitations in its implementation, including inadequate training for volunteers and low participation and promotion among community members [ , ] . a evaluation of kospen found that chv performance was positively associated with factors such as support and supervision by the community [ ] . these results suggest that it is important to ensure that chvs are integrated into the community to encourage their continued engagement. digital health technologies increasingly offer an opportunity to increase the reach and accessibility of health interventions and could complement face-to-face interactions with chvs. in , . % of malaysians reported using smartphones, including . % of people in urban areas [ ] . while higher-income malaysians are more likely to use smartphones, a majority ( . %) of malaysians in the lowest income group are smartphone users even with monthly income of rm (usd ) or less. digital tools such as mobile applications, messaging services, and e-learning are transforming how healthcare and health promotion activities are delivered. for example, the world health organization's (who) be he@lthy, be mobile initiative is building a toolkit of population-wide digital heath prevention interventions for ncds, including sms messaging, mobile applications for physical activity, and digital health education [ ] . in malaysia, the kospen@activ program uses a mobile application that syncs to wearable fitness trackers to encourage and reward physical activity competitions between users [ ] . digital technologies are providing new tools for the health workforce in facilities and in communities. mobile apps for chvs include platforms for communication with community members, decision support tools, and elearning to digitize chv training [ ] [ ] [ ] . elearning for chvs increases flexibility and reduces costs, allowing chvs to complete training from anywhere at the time they find most convenient. a study of chv training in south africa estimated that a blended elearning approach could reduce training costs by up to % when compared to traditional models [ ] . although digital interventions are promising, available evidence from lowand middle-income countries (lmics) largely consists of small-scale demonstration projects [ , ] . digital tools must continue to be scaled and evaluated in new settings [ ] . prior qualitative research conducted in malaysia found that individuals' responses to web-based health promotion tools are informed by their age, gender, and socioeconomic status, underscoring the importance of designing locally specific digital tools with the target user and context in mind [ ] . given the promise of community-based interventions and value of digital health tools, the better health programme (bhp) malaysia aims to reduce risk factors for ncds among the urban b through a combination of digital and in-person community-based interventions to alter the obesogenic environment. funded by the united kingdom's prosperity fund, bhp is an initiative to reduce morbidity and premature mortality due to ncds in order to cultivate a healthier and more productive workforce in eight countries (brazil, mexico, malaysia, myanmar, south africa, the philippines, thailand, and vietnam) [ ] . in malaysia, bhp is implemented by rti international in partnership with price-waterhousecoopers. bhp malaysia has been co-created with the malaysian ministry of health and aims to address ncds by expanding the evidence base around community-driven health promotion, improving the availability of healthier food options, and increasing b adoption and knowledge of healthy behaviors. during the project's pilot phase, we will co-create packages of interventions with communities, develop appropriate digital tools, and train chvs to partner with community organizations and businesses to implement the selected interventions. working with chvs, we will develop a system of supportive supervision and mechanisms that integrate and recognize chvs within their communities. we will evaluate this pilot phase to quantify the impact of the interventions on chv and community members' knowledge, attitudes, and practices related to ncds and ncd risk factors. we have built a research design into the project approach so that learnings can be consolidated, disseminated, and applied to project scale-up and sustainability. we aim to evaluate a community-based intervention combining in-person and digital support to strengthen chv capacity to interact with community stakeholders to address obesogenic environments and improve knowledge, attitudes, and practices related to ncd risk. we will compare changes in chv and community member knowledge, attitudes, and practices in matched intervention and control communities in kuala lumpur ( : ). simultaneously, we will engage with local businesses (through chvs and digital tools) to address some of the dietary aspects of the obesogenic environment. we seek to answer several questions: what interventions would b community members prefer to enable ncd prevention? how can digital tools and platforms assist chvs with their community engagement (community members and local businesses)? how do chv and community member knowledge, attitudes, and health practices compare before and after the pilot implementation of selected interventions? this quasi-experimental study uses pre-and postsurveys to evaluate the effect of bhp pilot interventions, comparing intervention and control sites. the research will be conducted in the federal territory of kuala lumpur, the national capital and largest city in malaysia. kuala lumpur (kl) is divided into districts for administrative purposes as per the kl city hall-city council which administers the city of kuala lumpur in malaysia (fig. ) . our geographical unit of focus is the kawasan rukun tetangga (krt), or neighborhood watch, which is a program under the department of national unity and integration. krts voluntarily organize community, welfare, and education activities to strengthen community cohesion and enhance racial unity and integration. there are krts in kl, of which offer affordable housing to benefit lower income groups. the ministry of health, malaysia, has classified kl into four main districts-cheras, kepong, titiwangsa, and lembah pantai, for ease of administration of health programs (table ). four ministry of health district health offices oversee health initiatives in subdistricts of kl, including the management of health clinics located across the city. each health clinic serves more than one low-income community, but most lowincome krt residents attend the same clinic. cheras and titiwangsa are in the east while kepong and lembah pantai are in the west (fig. ). cheras and kepong districts have been randomly selected for pilot implementation to ensure adequate geographic representation. pilot krts will be from these two districts. selected krts within the districts of cheras and kepong have been mapped according to a dominant ethnic group to ensure representation of malaysia's three main ethnic groups-malay, chinese, and indian. based on the selection criteria, a total of six krts (three interventions and three control groups) matched on ethnicity will be selected ( table ) . overall, three krts will serve as intervention krts and three will serve as the control. we plan to pilot the bhp interventions for months. we will recruit urban b community members and chvs. a total of community members across six krts ( respondents per krt) will be recruited. to be eligible to respond to the interviewer assisted survey, respondents must be years or older and be able to provide informed consent. during the recruitment, we will ensure an equitable distribution of gender and all eligible age groups. we will recruit chvs ( in intervention and in control krts) who agree to participate for the entire duration of the pilot. recruited chvs must be years or older, have at least completed a primary level of education, be able to read and write in malay or english, and speak at least one of the local languages (malay/ tamil/mandarin/cantonese). knowledge, attitudes, and practices (kap) survey the survey will assess health literacy and knowledge about ncd prevention, such as tobacco use, alcohol consumption, physical activity, diet, and health-seeking behaviors among both the community members and chvs. it will be repeated after the -month pilot intervention program and will be used to evaluate the impact of the program. we will assess the digital needs of chvs across the intervention krts to inform the design and adaptation of health-focused digital health tools during the development and implementation of the interventions. the survey will gauge chv digital literacy, device access, and priorities related to digital health app format and content. we will apply the above findings to design and conduct a discrete choice experiment (dce). this method involves community participation in the intervention development process. through the dce, we will quantify the preferences of participating communities to choose between sets of potential interventions to identify their priority interventions and quantify the relative strength of their preferences for each intervention. the community members across the three intervention krts will be involved in conducting in-person dce. the results will then inform the emphasis of program interventions in each krt, facilitating a responsive program design and community ownership. the kap and digital needs assessment surveys are newly generated based on established evidence and tools that have been previously validated in lmic contexts. we reviewed, for example, the malaysia national health and morbidity surveys and an ncd risk factor surveillance survey for malaysia to aid in the development of the kap survey. the digital health needs assessment survey was informed by best practice guidelines from the who and other organizations [ , ] . following the review of these guidelines, we adapted specific questions from existing digital literacy assessments for community health workers to create a first version of the planned survey [ ] . we carried out content validation of the tools with assistance from the ministry of health ncd experts, who reviewed and offered recommendations to ensure the tools' contextual relevance and acceptability. we sought support from local and international experts in ncds and information and communication technology to help refine the tools and advise on content validity for the malaysian context. we will pilot test the survey with a sample of community members at a different site to ensure that they are appropriately localized and clear to our b audience. for identifying the interventions to be included in the dce, we reviewed established guidelines and databases such as the who best buys, disease control priorities rd edition, and the world cancer research fund nourishing framework [ , ] . from these sources, we assembled an initial list of evidence-based interventions that address obesogenic environments and ncd risk. we then conducted interviews with community leaders in b krts to discuss their community's priorities for health and ncds, their perceptions of how well existing health programming is working for their community, and their preferences and thoughts on the interventions we identified. we also consulted with local academic experts with experience in obesity prevention and nutrition policy in malaysia. we reviewed the interventions with ncd experts at the ministry of health, malaysia, to confirm their relevance, feasibility, and acceptability for b communities in malaysia. taken together, the inputs from literature, community leaders, local experts, and our team's technical experience, we identified a number of proposed interventions to include on the dce survey. we plan to modify these interventions, if needed, considering the results obtained from the kap survey. we will pilot test the dce survey with community members at a different site to ensure that the content and format are relevant, understandable, and appropriate to the b community. local businesses such as food vendors, restaurants, and supermarkets are an important segment of the environment in which a community thrives. their support and involvement in bhp are therefore critical. our strategy of engaging local businesses will be to outline and share the bhp program benefits to the local business owners or president of local business associations by offering them opportunities for involvement, with support and introduction by krt or kospen leaders who are familiar with the local businesses landscape. such presentations will serve as promotion efforts, set the stage for later recruitment efforts, and encourage different business groups to consider the most appropriate form of participation in the program besides building rapport with them. local businesses will be invited to participate in multistakeholder focus group discussions through assistance from chvs. they will work with other key stakeholders from the community to help develop and co-create intervention activities that are of mutual benefit for them and the community members. ongoing, regular communication will inform local businesses of program development and opportunities for participation in order to encourage their long-term support. we will use spss software to analyze the resulting data. all variables in the kap, digital needs assessment survey, and dce will be tested for normality by using skewness and kurtosis values. we will summarize each variable with descriptive statistics, including frequency, mean, range, percentage, and standard deviation. since the kap and digital needs assessment surveys will include a few open-ended questions, we will translate the responses into english, back-translate to check translation quality, and analyze them using a thematic analysis methodology. we will construct a knowledge score for each respondent which will sum up all the responses obtained through the kap. similarly, we will construct a summary score for participants' digital literacy and perceptions of digital technologies. bivariate analyses will be performed on all outcome indicators of the kap survey by age, gender, ethnicity, income level, and other associated individual-and community-level attributes. we will test for statistically significant differences in outcomes across groups using chi-square tests (categorical outcomes) and t tests (continuous outcomes) with significance thresholds of . . we will measure changes in knowledge, attitudes, and practices between baseline and endline. we will then conduct a regression analysis to determine predictors of knowledge, attitudes, and practices among the study population. we do not anticipate having statistical power to conduct sub-group analyses for the digital needs assessment survey given its small sample size. the quality of dce responses will be assessed by evaluating the completeness and internal validity of the data. we will include several questions in the survey that will be used to confirm participant attention and comprehension, but which will be excluded from the dce analysis [ ] . these questions will include repetition of questions to confirm participants select the same option each time, or control questions in which participants are asked to choose between two sets of interventions in which one set is preferable in all of the included attributes. for example, participants may be asked to choose between one set in which all possible interventions are included and one in which no interventions are included. we will perform a conjoint analysis to model community member preferences for individual interventions, with attribute levels modeled as categorical variables. we will use a mixed-logit or random-parameter logit model. where feasible, we will carry out sub-group analyses to identify key characteristics on which individual preferences vary, such as krt, age, gender, ethnicity, income level, and other relevant parameters. to report the findings from the focus group discussions with local businesses, we will use the audio-recordings to finalize the transcripts, which will be translated into english. we will conduct a thematic analysis in which we will systematically analyze the findings from each focus group discussion to identify common themes and similarities and differences amongst the target audience and will use qsr nvivo for these analyses. proper data storage and security are critical to protecting data integrity, optimizing data usability, and safeguarding potentially sensitive or personally identifiable information. data collected using electronic and data management platforms will be securely stored on a cloud-based management system with role-based access controls. if hard copy records are required, all physical copies of documents will be stored in locked file cabinets. all data will only be accessed and managed by the authorized research team. we will de-identify all the data before analysis to protect participant privacy and will only be shared with the program team and other collaborators in aggregate. we will not share any individual-level or personally identifiable data outside of the research team. we will maintain the study data for years following completion. bhp malaysia partner rti international will work closely with a fieldwork company to collect data. the fieldwork firm will complete a mandatory training of days to learn the study protocol, procedures for data collection, and interactions with participants, characteristics of a good interview, scheduling interviews, handling difficult interviews, procedures for storing and sharing data, and special considerations for human subjects research and protections, including safeguards for human subjects data and how to conduct the informed consent process. three days of in-person training will include daily practice and observation sessions. all participating field interviewers will complete the training and display competency in the study procedures, including following all safety procedures with respect to covid- guidelines, prior to beginning data collection or interactions with participants. we will work closely with the fieldwork company throughout the data collection period. as part of regular progress update meetings with the fieldwork company, we will provide notification of any changes to the protocol, consent materials, and/or data collection tools. throughout data collection, we will monitor the quality of data collected by the fieldwork company by conducting random checks of the data being collected. a subsample of the data collected will be screened by the research team for its accuracy and completeness, and any necessary feedback shall be provided to the fieldwork company. a sub-sample of interviews will also be directly observed to ensure that appropriate human subjects protections and informed consent procedures are being practiced. we have registered the protocol for bhp malaysia with the malaysia ministry of health national medical research register. we have obtained ethical approval for the bhp malaysia from the ministry of health medical research ethical committee (mrec) [approval number: nmrr- - - (iir)] and plan to report any modifications to the study protocol to mrec in a timely manner. we will ensure written informed consent from all respondents before we begin data collection. participation in the surveys is entirely voluntary. all individuals in intervention krts will have access to participate in the selected interventions, regardless of whether they are randomly selected to respond to the surveys. all participant responses will be confidential, securely stored, and de-identified prior to analysis. the malaysian ministry of health and bhp malaysia partners propose an innovative program to improve the obesogenic environment of the urban poor. the initiative relies on volunteer chvs to partner with business owners and other community stakeholders to lead changes that community members themselves have prioritized. this community-driven approach complements ongoing, formal primary care services, recognizing that many determinants of ncd risk occur in community environments. it builds from the recognition that change must be owned to be sustained. while most projects determine their interventions at the outset, bhp malaysia looks forward to community members selecting and prioritizing evidence-based approaches. this co-creation process will determine which interventions will be most locally relevant, feasible, and needed. our project recognizes the diversity of challenges that can add up to an obesogenic environment. we hypothesize that collaboration between community stakeholders will result in increased adoption and knowledge of healthy practices that reduce ncd risk and improved the availability of healthier food options for the b population. communities will define and act on their priorities. bhp malaysia has learned from kospen and its predecessor community health efforts and builds on their model of chvs as trusted communicators and agents of change at the krt level. unlike kospen, bhp malaysia does not emphasize referrals to primary health facilities for ncd screening and treatment. its focus is squarely on community-based prevention and reduction of ncd risk. bhp malaysia will address the obesogenic environment facing the diverse and full population of b residents in selected krts. as such, the program has the opportunity to alter diet and physical activity among community members before they might be considered in a stricter sense to be "at risk" for ncds. bhp malaysia is focused on the urban poor in recognition that the poor are disproportionately affected by negative environmental factors that increase ncd risk. b populations have the highest rates of diabetes in malaysia [ ] and are at the greatest risk of impoverishment from the health problems caused by ncds. they also have the lowest access to preventive and curative care. within the b , we will also target additional socially excluded groups, including women, diverse ethnic groups, and people with disabilities, who face further disparities and barriers to ncd prevention and health promotion activities [ , , ] . we anticipate that this emphasis on the poor and socially excluded groups will address the fundamental inequities associated with ncd risk. chvs must be adequately supported to excel. rising coverage of digital technology opens numerous opportunities to increase communication, education, and supportive supervision. the arrival of covid- and social distancing measures has sped and highlighted the need for the flexible, remote support that digital tools can offer. we look forward to exploring how digital technology can equip chvs in their health promotion and local advocacy efforts. bhp malaysia is a project with a research design. we have so much to learn from what works and what does not work in equipping communities to drive positive local change to reduce ncd risk. the kap survey, digital needs assessment, and dce will inform the project approach and reflect the project pilot's effects. regular process evaluations will reveal project challenges and strengths. bhp malaysia anticipates adapting its work in response to lessons learnt along the journey. although ncds are the leading causes of mortality and morbidity around the world, the literature includes scant evidence of effective, scaled initiatives to stem the rising tide. the innovation of bhp malaysia is its focus on a bottom-up approach in which communities define and act on their priorities alongside engagement with local businesses which are elements of an obesogenic environment. by sharing our project approach and learnings along the way, we intend to expand the evidence base around community-driven health promotion. the relevance of this research will add value beyond national and subnational ncd policies and programs in malaysia to similar settings that are working with chvs to reduce ncd risk. institute for health metrics and evaluation. the global burden of disease results tool institute for public health. national health and morbidity survey (nhms) : non-communicable diseases, healthcare demand, and health literacy-key findings. selangor: ministry of health malaysia the nutrition and health transition in malaysia the nutrition transition and obesity in the developing world dissecting obesogenic environments: the development and application of a framework for identifying and prioritizing environmental interventions for obesity population projection for development planning in malaysia. palm garden hotel, ioi resort what is driving global obesity trends? globalization or "modernization"? global health tackling socioeconomic inequalities and non-communicable diseases in low-income and middle-income countries under the sustainable development agenda the overweight and obesity transition from the wealthy to the poor in lowand middle-income countries: a survey of household data from countries patchy progress on obesity prevention: emerging examples, entrenched barriers, and new thinking institute for public health (iph). national health and morbidity survey dietary health behaviors of women living in high rise dwellings: a case study of an urban community in malaysia whole-of-community" obesity prevention: a review of challenges and opportunities in multilevel, multicomponent interventions a systematic review and meta-analysis of whole of community interventions to prevent excessive population weight gain shape up somerville's return on investment: multi-group exposure generates net-benefits in a child obesity intervention the outcomes of health-promoting communities: being active eating well initiative-a community-based obesity prevention intervention in victoria, australia addressing non-communicable diseases in malaysia: an integrative process of systems and community world health day -lessons from malaysia on universal health coverage techinical report evaluation of effectiveness of implementation of "komuniti sihat perkasa negara" (kopsen) programme in malaysia -phase . kuala lumpur: institute of public health, national institues of health, ministry of health evaluation of the implementation of the komuniti sihat pembina (kospen) programme in malaysia role performance of community health volunteers and its associated factors in kuching district sarawak malaysian communications and multimedia commission geneva: world health organization and international telecommunication union digital health tools for community health worker programs: maturity model and toolkit: healthenabled human papilloma and other dna virus infections of the cervix: a population based comparative study among tribal and general population in india cost comparison model: blended elearning versus traditional training of community health workers acceptability and use of mhealth tools by auxiliary midwives in myanmar: a qualitative study challenges and prospects for implementation of community health volunteers' digital health solutions in kenya: a qualitative study digital technologies for health workforce development in low-and middle-income countries: a scoping review web elements for health promotion in malaysia training community healthcare workers on the use of information and communication technologies: a randomised controlled trial of traditional versus blended learning in malawi africa obesity prevention tackling ncds: 'best buys' and other recommended interventions for the prevention and control of noncommunicable diseases. cc by-nc-sa . igo. geneva: world health organization conjoint analysis applications in health-a checklist: a report of the ispor good research practices for conjoint analysis task force publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we thank the uk national health service joint unit of the prosperity fund better health programme for their review of the programme. this work is funded by the uk's prosperity fund better health programme, which is managed by the uk foreign, commonwealth & development office. it is supported by pwc (pricewaterhousecoopers) in south east asia and implemented in malaysia by rti international. authors' contributions ik coordinated the manuscript development. ik developed the manuscript outline in collaboration with cn, scl, pk, ac, and fim. ik, cn, ek, and scl contributed to the draft development. pk, ak, ac, kfm, and fim provided valuable inputs for revising the manuscript. ik and cn finalized the manuscript. the authors read and approved the final manuscript. ethics approval and consent to participate an ethical approval has been obtained from the ministry of health medical research ethical committee (mrec) [approval number: nmrr- - - (iir)]. we will ensure written informed consent from all respondents before we begin data collection. participation in the surveys is entirely voluntary. the authors declare that they have no competing interests key: cord- -ihsr bhp authors: spanemberg, juliana cassol; simões, cinthia coelho; cardoso, juliana andrade title: the impacts of the covid‐ pandemic on the teaching of dentistry in brazil date: - - journal: j dent educ doi: . /jdd. sha: doc_id: cord_uid: ihsr bhp a new disease called coronavirus disease (covid‐ ), caused by the severe acute respiratory syndrome coronavirus‐ (sars‐cov‐ ) virus, was discovered in the city of wuhan in china in december , and has reached, quickly and progressively, several countries on different continents. even before the world health organization recognized the covid‐ epidemic as a pandemic, the brazilian ministry of health had already declared covid‐ a national public health emergency due to the confirmation of cases in brazil. in this scenario, the educational sector was one of the first to suffer the effects of the pandemic soon after the announcement of social distancing as a way to prevent the collapse of the unified health system. the aim of this paper is to report how brazilians dental schools are leading with the new coronavirus pandemic. a new disease called coronavirus disease , caused by the severe acute respiratory syndrome coronavirus- (sars-cov- ) virus, was discovered in the city of wuhan in china in december , and has reached, quickly and progressively, several countries on different continents. in early march, the director general of the world health organization (who) recognized the covid- epidemic as a pandemic because the disease had already caused deaths and infected > , people in countries. in february, the brazilian ministry of health had already declared covid- a national public health emergency due to the confirmation of cases in brazil. in this scenario, the educational sector was one of the first to suffer the effects of the pandemic soon after the announcement of social distancing. the brazilian supreme court of justice decided to grant to states and municipalities the decision on the implementation of necessary measures to fight the pandemic using epidemiological data from each location as a thermometer. however, following the who guidelines, most mayors and governors suspended face-to-face classes at education institutions, among other measures, aiming to prioritize social isolation in an attempt to reduce the spread of the virus and prevent the collapse of the unified health system. then, the ministry of education authorized the replacement of on-going classroom subjects for remote classes in undergraduate courses using information and communication technology platforms. the objective was to maintain the student's study routine and create a virtual teacher-student contact, so that there would be the least possible damage to the subjects' teaching plan and the academic calendar. higher education institutions, on an emergency basis, provided digital platforms for remote classes. however, there was no prior training, which requires a gradual adaptation of the use of such tools. thus, professors sought alternatives and teaching strategies to engage students who had opted for face-to-face classes upon entering undergraduate courses. with such a challenge, undergraduate and graduate courses in dentistry and students who opted for face-toface classes had their theoretical classes delivered live in remote classes. the practice (laboratory, preclinical, and clinical), which is important for the development of specific skills of dentist training, was suspended. there was also a search for alternative methods to apply tests using tools of information and communication technologies (icts) aiming a safe application of virtual tests. however, the adoption of these technologies in brazil is still limited due to low accessibility by the low-income population, which does not always have compatible electronic equipment and access to a quality internet network. new multimedia tools have driven significant social and cultural changes in modern society. these resources have allowed the maintenance of the student-teacher relationship in real time, differentiating it from distance learning. icts potentiated the flow of information in remote educational environments, allowing the student, an interacting individual, to break hierarchical knowledge. a group from italy, a country severely affected by the pandemic, reported in an article that self-learning among students improved their ability to use online resources and somehow encouraged learning independence. however, it is responsibility of dentistry faculties to promote, by structuring pedagogical projects, the development of students' skills in diagnosis, planning, and treatment of orofacial pathologies through the clinical care they offer to the population. adaptation of techniques and refinement of manual dexterity are part of the daily training of dentistry students. however, how can these qualities be developed within a pandemic scenario? could these activities be carried out in a simulated way using specific software or other techniques? one of the challenges of higher education is to create new pedagogical models that promote students' creativity in order to avoid exhausting the traditional model of teaching centered on the figure of the teacher. in view of the reality of the brazilian population in the covid- epidemic, the work of teachers has become challenging. the search for alternatives for the development of students' skills and competences, as provided for in the pedagogical plan of courses, has been incessant, highlighting remote classes. for basic courses, the use of virtual blades and other software allows manual practice through virtual means. the challenge is greater in specific courses. thus, a suggestion is to work on the discussion of interdisciplinary clinical cases in small groups of students aiming to plan, analyze, interpret, and make logical decisions, in addition to working on communication and interpersonal relationships. other possibilities are the adoption of software to perform interactive activities, such as kahoot!, game design by students, quiz etc. health promotion can be worked on by disseminating educational material, such as educational videos and folders, on social networks. another possibility is to make calls and send messages to patients at the school clinic using the institution's database. such contact with the patient aims individual educational guidance by updating signs and symptoms of disease progression, always following guidelines and the legislation of the respective agencies in brazil. for the development of manual skills in different dental specialties, it is possible to propose the acquisition or adaptation of training materials, such as the use of dish-washing sponges, ox tongue, pig jaw, wax/soap sculptures, assembly training in a semi-adjustable articulator, molding, making removable orthodontic appliances, etc. all these activities are carried out with remote supervision by the teacher who assists students, guiding and correcting them whenever necessary. in view of these uncertainties, the organization of commissions of teachers, dental class councils, and the brazilian dental education association (abeno), thought of a safe way for students and professors to return to undergraduate and graduate courses in dentistry. this proposition was based on evidence and scientific publications. the group published manuals on biosafety standards containing guidelines for adapting physical spaces, necessary equipment, and behavior in school clinics to this new reality until the development of a vaccine. the american dental association and the brazilian federal council of dentistry (cfo) have recommended the use of extraoral imaging tests (panoramic radiography and cone beam computed tomography) preferably to intraoral examinations due to the tactile stimulus to salivary flow during execution of these techniques. , in addition, the brazilian association of dental radiology (abro), together with the cfo, carried out a campaign to increase the digital flow of imaging exams performed in dental radiology clinics, eliminating the stage of transport and handling of printed exams aiming to prevent the virus from spreading. however, it is known that there is a need to adapt practice physical spaces of undergraduate courses in dentistry in brazil for the interpretation of these digital images. on the other hand, the low purchasing power of most patients seen in clinical schools, who cannot afford ct scans, is well known. in this context, it is important to emphasize that intraoral radiographs have certain indications and are valuable in providing complementary data essential to the diagnosis of some pathologies. they also help in planning. therefore, they must be performed whenever necessary. , in addition, one of the safest ways to acquire practical clinical skills in healthcare, including dentistry, is simulation exercises without the need for the student's physical presence in the clinical environment and, obviously, without a direct contact with patients. the advance in virtual reality (vr) has allowed simulation technologies to create a series of opportunities for education systems in health centers. such systems provide the tutor and students with continuous and integrated feedback. vr simulators have the capability of tactile feedback, which allows students to touch and feel the dental tissue virtually. studies have shown that the use of vr has improved the acquisition of manual dexterity in dentistry courses in the operative area. however, a high investment from colleges is required to offer this type of teaching methodology. thus, as professionals of dental teaching institutions, we must be aware of new education models and new vr simulation technologies and consider them as a useful and complementary tool for our students, given the current world pandemic situation and future illnesses that may arise. perhaps this modality, already practiced in some developed countries, will become fundamental in universities and a conventional dental training approach. its effective and safe use for both students and patients is possibly one of the many changes that will allow remote learning during the covid- pandemic and in the years that follow this event. finally, a greater attention is needed to the mental health of the student and the teaching staff. despite existing knowledge, the scale of this pandemic is different, as are its effects on the population. a recent study has shown that this pandemic has deleterious effects on the mental health of university students. this fact reinforces the need to continue investigating this issue to understand the mechanisms of psychological reactions underlying such an atypical and challenging period of life. sadness, anxiety, and confusion generated by the information transmitted by the media have been detected and are constantly associated with isolation. the results of a study have shown a significant increase in psychological distress in university students during a pandemic period compared to that of normal periods. thus, it is likely that students may need counseling and psychological support services during and after the covid- pandemic to min-imize the negative impacts on teaching and the development of their skills. there are reports of students taken by the fear of being infected by the virus, the lack of contact with colleagues, and the insecurity of real learning during this period. institutions must have the feeling of knowing how to deal with this situation in the best possible way and with less impacts for the entire community. o r c i d juliana andrade cardoso msc https://orcid.org/ - - - who director-general's opening remarks at the media briefing on covid- - use of dentistry education web resources during pandemic covid- covid- : its impact on dental schools in italy, clinical problems in endodontic therapy and general considerations american dental association. ada interim guidance for minimizing risk of covid- transmission conselho federal de odontologia. manual de boas práticas em biossegurança para ambientes odontológicos computer assisted learning: a new paradigm in dental education use of simulation technology in dental education anxiety, depression and stress in university students: the impact of covid- key: cord- -wacoz t authors: thirumalaikolundusubramanian, ponniah; meenakshisundaram, ramachandran; senthilkumaran, subramanian title: ethics, legality, and education in the practice of cardiology date: - - journal: heart and toxins doi: . /b - - - - . - sha: doc_id: cord_uid: wacoz t advances in diagnostics, drugs, and devices have revolutionized cardiology practice, and improved quality of life of the patients. however, awareness, achievements, and advances in cardiac health care have enhanced the demands and expectations of the community, which lacks awareness about the social, economic, administrative, professional, and technical constraints or limitations of implementation. being unfamiliar with medical ethics and legal aspects of care, and suboptimal virtues among physicians, have led to patients and the public utilizing legal remedies. in addition, sophistication of medical practice, increasing costs of health care, involvement of insurance systems, increased awareness and high expectations from the community and patients, and increased participation of the media have altered the attitude toward claiming compensation and acquisition of health care delivery among the public. in view of the changing trends of consumers and emerging areas in health care, providers must get accustomed to patient empowerment and come up to their expectations. interactive programs on these aspects in medical education will help students understand not only the intricacies of medical ethics and the laws and shortcomings of health professionals and/or health systems, but also strengthen their knowledge of ethics and laws to improve their practice. principles of ethics and legal issues have to be discussed at every stage of medical education. to improve the quality of the physician–patient encounter, we need to develop formal and informal curricula about effective communication skills. this chapter also highlights preventive measures and educational aspects of cardiology practice. cardiology is a branch of medicine characterized by state-of-the-art biomedical technology. evidence-based medicine is incorporated in the practice of cardiology. ethical dilemmas known to the specialty arise from the decisions to be made between what can be done and what should be done for varieties of cardiovascular pathologies. some of the ethical deliberations are resurrection of a patient with acute coronary syndrome or malignant arrhythmias. the practice of cardiology is increasingly constrained by guidelines, regulations, and legal considerations. all doctors, including cardiologists, have a primary duty of care to individual patients, in addition to their responsibilities to society, institutions, and colleagues. among cardiologists, the propensity to test and treat is closely associated with fear of malpractice suits. cardiology practice has gained importance as a result of the introduction of advanced diagnostics, drugs, and devices. early recognition and appropriate intervention minimizes the consequences of cardiac illnesses, which in turn reduces the cardiovascular mortality and morbidity. at the same time, awareness about cardiac care among community members has increased their expectations. when the expectations are not achieved, legal issues creep in. in an analysis of judicial sentences related to cardiology in spain, % of the decisions were made for plaintiffs and the defects were misdiagnosis including gaps in communication and informed consent. , misuse and unethical practices related to state health insurance in india was reported by a weekly magazine, and it urged medical associations to curtail such violations. factors linked to malpractice claims are patient dissatisfaction, noncompliance with patients' demands, incorrect diagnosis, complication(s) related to procedures, medical malpractice, and so forth. even though many physicians recognize impairment and incompetency among coprofessionals, they generally do not bring them to the attention of the respective authorities or report them. medical ethics is a dynamic field that plays an important role in cardiovascular medicine. codes of ethics, advanced directives, informed consent, privacy rules, and disclosure of conflicts of interest have changed the practice of cardiology. ethical issues are concerned with the ideas of right or wrong, duties or obligations, and rights or responsibilities. there are always gray areas in ethics. ethical norms derived from various laws and federal and state constitutions (fundamental laws of nations) are related to citizens' welfare, safety, and security; professional councils and statutory organizations that deal with practitioners, policies of professional organizations, professional standards of care, fiduciary obligations, institutional policies, and judgments delivered; and public health regulations and other laws related to patient care and the hospital environment. the fundamental principles and the expectations for ethical conduct are: codes of ethics provide a wealth of information on a variety of aspects such as virtue-based ethical decision making, professional responsibilities, counseling relationships, consulting, private practice, evaluation and assessment, research and publications, counselor education, training, and supervision. keith-spiegel and tabachnick offer eight general ethical principles: respect for autonomy of others, doing no harm, benefit to others, fairness and equity, fidelity and honesty, dignity, caring, and doing one's best. trust patients and the public trust doctors and health care systems, despite limitations. trust has various dimensions and determinants. developments in sociophysical scenarios, market-based diagnostics, drugs and devices, economic crises, and the needs of providers have had an affect on systems and services. in addition to blind trust, gopichandran described four more types of trust: calculated trust, trust but with verification, skeptical trust, and impersonal trust (with some overlapping features among them). information given to patients and/or caregivers should have certainty, clarity, and eliminate divergent meaning; whereas komesaroff suggested that clinical communication often requires the deliberate preservation of uncertainty. the doctorÀpatient relationship is the cornerstone in health care. this helps with diagnosis, therapy, prevention, and compliance, as well as improvement of psychosocial quality of life and patient satisfaction. medicolegal duties are essential components to maintain a physicianÀpatient relationship. web-based medical tourism facilitators are the connectors between foreign patients and host countries that identify concerns regarding the information displayed. patients or caregivers are attracted by price comparisons, perceived quality of care, additional support services, other social websites, and patient blogs. these sites do not mention patients' rights. e-health is a multidisciplinary field. the facilitators of web-based services have to be educated about the ethical aspects of patient care, be prevented from exploiting patients or clients, and be required to respect privacy and confidentiality. international organizations, such as the world health organization (who) and the united nations educational, scientific and cultural organization (unesco), have formulated standard ethical guidelines for the quality of health information available on the internet. the various organizations need to focus on four basic principles of e-health information: self-regulation, evaluation of information, regulation, and awareness of users. facilitators of medical tourism have to ensure confidentiality; disclose health regulations, ethical guidelines, and laws related to compensation; provide information on potential risks of travel, facility stays, and procedures; and divulge the correct details of hospitals and providers. modern medicine is supported by advanced technologies and devices used for the purposes of diagnosis, prevention, monitoring, alleviation of symptoms, and therapy. each hospital has a plethora of machines. ubiquitous health care is an emerging field of technology. it uses a variety of environmental and patient sensors and actuators to monitor and improve patients' physical and mental conditions. such machine-dependent health care poses challenging ethical questions related to trust, efficacy, and societal issues; longevity gaps related to economic status; and clinical problems related to failure of medical devices have led to mounting concerns in the regulatory processes. À medical, technical, and computer professionals have to collaborate to develop and deploy ubiquitous health care systems. geppert and shelton have described various aspects of consultation. it is a service and the professionals who provide consultation should follow certain principles and norms. dubois et al. identified environmental factors that enable wrongdoing in medical practice and research. to avoid wrongdoing, education and policy of ethics have to be strengthened. health care providers face ethical, moral, psychological, and medicolegal challenges while providing care for end-stage heart failure. although cardiac transplantation may have limitations, left ventricular assist devices are becoming a more prominent therapeutic option for some. while dealing with such cases, physicians find themselves in a peculiar situation of having a professional obligation to perform whatever is the best for the patient, but doing it in the context of shared decision making. at the same time, health care providers must refrain from doing anything that might conflict with the law or raise legal concerns. in some clinical cases, discussion of medical futility reflects an apparent conflict between respect for patient autonomy and the preservation of ethical integrity of the medical profession. the danger of futility-based exception to informed consent includes the emergence of paternalism and physicians' avoidance of difficult discussions with patients about dying and death. hariharan et al. have described indifference toward ethical and legal issues among doctors and nurses, and the need for appropriate training. integrating the use of complementary therapies in medical practice increases the physicians' risk for license suspension or revocation. , it is suggested that physicians should continue to provide conventional medical care. medical errors are bound to happen. even though they may be known, errors often do not come to light or go undocumented because of the inherent threatening attitude of the existing health care system and the possibility of self-harm. moreover, medical errors are not discussed as a part of medical education. in most situations, nurses and paramedical professionals do not have the liberty to write medical errors in their reports and are not trained to document such incidents because they are considered suboptimal. as a result, prevalence cannot be estimated, occurrence cannot be prevented, and root caused cannot be assessed. the complexity of the current health care system contributes to various types of medication errors, leading to legal liability. reducing such errors is an ongoing process of quality improvement, which is an essential component of clinical audits. in some cases, root cause analysis and redesigning faulty systems have reduced medication errors. medical laboratories have responsibilities to three main groups: patients, professional colleagues, and society. they are required to maintain high standards in sample collection, good laboratory practices, reporting, monitoring, maintenance of records, and confidentiality. while making decisions about resuscitation, health care providers should be guided by science; individual patient or surrogate preferences; local policy and legal requirements with reference to respect for autonomy, advanced directives, living wills, patient self-determination, do not attempt resuscitation (dnar) orders, withholding and withdrawing cardiopulmonary resuscitation (cpr), and terminating resuscitation efforts. all these should include providing emotional support to family, limitations of care and withdrawal of life-sustaining therapies, ethics of organ donation, and privacy. deliberations about ethical issues among cardiothoracic surgeons have gained prominence in recent years and is starting to become part of medical schools' curriculum. a recent review described various ethical issues related to cardiac surgery in a detailed manner. wait time for access to a cardiovascular specialist's evaluation and therapy has an impact on a vulnerable population in many ways including lawsuits. shortage of cardiologists and demands from the community have been discussed by professional societies, universities, and health ministries. if a fetus is found to have a cardiac anomaly, the ethical principle of autonomy creates a responsibility for the physician to help the pregnant woman make an informed decision based on her values and aspirations. a decision to terminate is partly a medical matter and partly a personal decision bound by legal, cultural, and religious constraints. "do no harm" is an established mantra of medical ethics and the profession. in the modern era, medical bills are escalating and are the leading cause of financial harm. physicians, while providing patient-centered care, should also consider patients' financial well-being. they should understand financial ramifications, provide appropriate care, and optimize care plans for individual patients considering their socioeconomic status. in order to achieve patient-centered care, family members and/or caregivers need unprecedented education and assistance. this will entail a fundamental shift from individual autonomy to family-and caregiver-centered care. ward rounds provide a benefit to patients that is safe, effective, and efficient. in addition, rounds can lead to staff and patient satisfaction. when various levels of health care providers see and talk to patients, they gain confidence and are more satisfied. in addition, ward rounds involve teamwork, where senior and junior doctors, medical students, nurses, and paramedical professionals share patient information and gain knowledge. standard ethical guidelines need to be practiced while disseminating information about health, disease, institutions, and physicians to the media. the media (i.e., print, television, internet) has become a powerful source for sharing information and knowledge. issues related to ethics and the media, including showing patients in news stories or taking pictures of them, have to be evaluated, and students of health sciences and practitioners/physicians should be aware of these issues. the importance of the media was revealed during the epidemics of severe acute respiratory syndrome (sars) and the h n influenza infection. it has been suggested that the media become a partner in health care delivery to carry messages quickly to the population, to enforce prevention or therapeutic strategies, and to protect communities from hazards. the medical profession is considered a noble profession. ethics is important for the correct conduct of the professionals and practitioners. there are two levels in a teacher's ethics: legal and/or administrative and personal. medical educators have various roles including teacher, manager, administrator, researcher, and physician, and all roles are governed by and require a code of ethics. in clinical teaching, patients are brought to a consultation room or students are taken to the patient for bedside instruction. in developing countries, many times ethical principles are violated or not followed when patients are involved in medical education. principles of ethics have to be discussed at every stage of clinical teaching. like the fact that human beings need oxygen to breathe, science needs research to live and progress. thus, research is an essential component in the science. publications help exchange and share knowledge for the betterment and advancement of medicine. therefore, authors are expected to follow standard ethical guidelines when submitting research for publication. hall et al. have noted that cardiac patients should be assessed by cardiologists as a matter of course. the authors suggested that health care providers listen to patients' various needs; provide access to information technology (it) for audit, clinical governance, and continuous professional development (cpd); and collect valuable outcome data. the authors, while discussing human rights, stated that cardiac cases should not be delayed when starting treatment or denied ethics for want of resources because of an unpredictable response from the illness. defensive medicine is defined as the ordering of tests, procedures, and visits and/or referrals, or avoidance of high-risk patients or procedures, primarily to reduce malpractice liability. a study from israel revealed that defensive medicine is prevalent, especially among surgical specialties, and more so among those exposed to lawsuits. studies have revealed that defensive medicine is a well-known practice in industrialized countries. emergency medicine, general surgery, neurosurgery, obstetrics, gynecology, orthopedic surgery, and radiology specialists were common in defensive medicine and were affected more by liability cases. the influencing factors for defensive medical practice are increasing demands of the patients, lack of resources, work and patient loads, deviation from standard guidelines, and increasing lawsuits and compensation amounts. measures to reduce lawsuits and complaints are improving the quality of care, clinical audits, anonymous disclosure of medical mistakes, resources, practicing standard guidelines, lawsuit immunity, and no-fault compensation. current public reports compare health care providers in terms of quality or cost to help consumers, who in turn decide where and from whom to seek care. in view of the changing trends of consumers, health care providers need to become accustomed to patient empowerment and meet their expectations. the public expects standard guidelines for treatment; however, they too have limitations, and conflict of interest (coi) is prevalent in the ones related to cardiology. sophistication of medical practice, increasing costs of health care, involvement of insurance systems, increased awareness and high expectations from the community, and increased participation of media have enhanced society's attitude toward claiming compensation and acquisition of health care delivery. this section outlines the various ways by which hospitals and health care providers can minimize their exposure to legal liability or consequences. there are numerous sources for obligation in emergencies and health care providers should identify legal issues and adopt a risk management approach, including characterizing the hazards, establishing a community profile, determining vulnerability, analyzing risk, and identifying and evaluating the management plan. an alternative way to avoid legal liability is to use the pprr (prevention, preparedness, response, and recovery) framework. laws include federal and state constitutions, statutes, and administrative and judicial decisions, which may vary from country to country and/or state to state; thus, a legal cause of action may be created by a constitutional right, by a statute, or by a common law. a cause of action consists of several distinct elements; however, the following must exist before there is legal liability: g plaintiff must have an interest that is protected by law g there must be a legal duty g a breach of duty by the defendant must be provable g an injury must be shown as damage to the protected party g it must be proved that the breach of a law caused injury negligence is the most common allegation (cause of action) in medical practice cases. it is legally defined as the omission of something that a reasonable person, guided by ordinary considerations of someone who regulates human affairs, would do; or the doing of something that a reasonable and prudent person would not do. therefore, negligence is a violation of the duty to use care. it arises when injury results from the failure of the wrongdoer ("tortfeasor") to exercise due care. the four elements required to establish a prima facie case for negligence are duty, breach, causation, and compensable injury. malpractice is defined as a tort or civil wrong committed by a professional acting in his or her professional capacity. the term malpractice refers to any misconduct that encompasses an unreasonable lack of skill or unfaithfulness in carrying out professional or fiduciary duties. malpractice law is a part of tort or personal injury law. the three goals of malpractice litigation are to deter unsafe practices, to compensate persons injured through negligence, and to exact corrective justice. plaintiffs' legal theories or causes of action against a physician are ethical negligence, wrongful death, loss of a chance of recovery or survival, battery and assault, lack of informed consent, abandonment, breach of privacy and confidentiality, product liability because of drugs and medical devices, vicarious responsibility for the acts of others, negligent referral, false imprisonment, defamation, failure to warn or control, negligent infliction of emotional distress, outrage, failure to report, fraud or misrepresentation (deceit), and loss of consortium. the issue of determining patient competence for medical decision making is often difficult. no absolute definition exists. competency is essentially the ability of a person to make a decision, and it is where understanding, appreciation, nationality, and religion begin. the prescriber exercises clinical skill in diagnosing a condition and determines which drug is indicated and in what dose. also, the prescriber has to provide sufficient information to the patient so as to make an informed decision whether or not to take the drug in the light of any possible adverse effects or risks that may be associated with the choice. illegible prescriptions have been a source of legal liability for both pharmacists and prescribers. therefore, prescribers should respond to queries from pharmacists to avoid the possiblity of injury to the patient and expensive litigation for all concerned. patients may be motivated to follow the directions on product information (pi). a consumers' movement view is that an off-label prescription indicates it as experimental; under such circumstances, the prescriber has to provide complete information to obtain the patients valid informed consent. prescribers should focus on evidence and drug quality, as opposed to commercial influences. both prescribers and pharmaceutical companies need ethical regulation. the practice of gifts from pharmaceutical companies to doctors alters the physicians' decision in prescribing the drug, which may be expensive and in turn could cause poor patient compliance. such practice should not be encouraged. pharmaceutical companies should disclose payments made to doctors above a certain value in their accounts, as is already practiced in some countries. in the united states, according to federal law, drug companies must disclose payments made over a certain value to physicians for research and other miscellaneous expenses. a health care provider is likely to be charged for civil actions against injuries resulting from lack of informed consent and standard care. medical treatment and malpractice laws are specific to each state and may vary with different countries. ethical and legal standards require a health care provider to obtain informed consent (ic) before delivering care. if the patient cannot provide it, a legally authorized surrogate decision maker may do so. in an emergency, when the patient is not legally competent to give ic and no surrogate decision maker is readily available, the law implies consent on behalf of the patient. information should be conveyed in a language and at a level that the patient can understand, and consent should be obtained for diagnostic tests, treatment's nature and character, anticipated results, and risks and benefits of treatment (or no treatment), along with other alternative options if available. the informed consent must be voluntary. the physician is responsible for obtaining ic and delineating the potential risks, benefits, and alternatives. physicians must be transparent for all potential ethical or financial conflicts concerning therapies and various other matters related to them or the devices employed in patient care. patients' reaction to confidentiality, liability, and the financial aspects of ic in cardiology research have been described by fortune-greeley et al. in a study, informed consent forms for cardiology practice were found to be suboptimal and lacking in clarity. the number of patients coming to the emergency department (ed) for diversities of toxicological emergencies is on the rise. each patient requires immediate care and yet is unable to give consent due to impaired consciousness-that is, prevents the patient from making informed decisions. some of the challenges faced by emergency physicians are acute organic impairment manifested by confusion, irrational thoughts, or dangerous behavior at times. they should familiarize themselves with relevant laws, which vary from state to state and country to country, and carry out immediate management to avoid liability for negligence and abandonment. there has been much discussion about ic and its types. medical ethicists claim that informed consent is valuable because it supports individual autonomy. in addition, it provides an assurance that patients and others are neither deceived nor coerced. in real clinical scenarios, there are variations among patients. since there are many distinct conceptions of individual autonomy, ethical importance varies. consent forms should be designed to give patients and others control over the amount of information they receive and the opportunity to rescind consent given already. limitations of informed consent are getting informed consent from the young, very ill, mentally impaired, or unconscious patients; or patients brought to the ed. other limitations are nonapplicability for public health policies, access to a patient's personal information by third parties, and duress or constraints experienced by patients. a patient has to prove the provider's failure to follow the accepted standard of care. there are various sources for standard of care. many states apply different standards to specialists and practitioners with accommodations for practice limitations such as availability of medical facilities, services, devices, and the like. common ethical issues are related to medical decision making and good patientÀphysician communication. laws and regulations on surrogate decision making are slowly evolving due to societal changes. it is highly recommended that readers become familiar with the various laws and regulations related to decision making according to their country or state. other areas of ethics with regard to treatment are advanced directives, futile resuscitation, withdrawal of treatment, missed diagnosis, medical issues, incorrect procedures or drugs, prescription-related matters, adverse effects to drugs, failure to screen family members, withholding diagnosis and information, organ transplantation or harvesting, and breach of confidentiality. hospital authorities are vicariously liable for the unlawful act of physicians or nurses, and/or others employed by them when such acts occur during the course and scope of individuals' work. doctors are often alarmed by the patient's bill of rights but should remember it is for everyone, including doctors. familiarizing oneself with the patient's bill of rights is especially important in this era of medical tourism. care providers should disclose patients' rights to their clients before entering a contract. benefits of a patient's bill of rights are: physicians have the privilege of making decisions to investigate, treat, or refer cases. decisions are influenced by clinical, psychological, economic, and other issues. during clinical practice, however, doctors may be at risk of abusing this privilege. similarly, in recommending leave on medical grounds, some doctors are likely to overuse their privilege for want of definitive guidelines. granting medical leave has an impact on productivity; thus, there is a need to develop standard guidelines for recommending a medical leave. both doctors and patients should realize that sickness, pain, and death are part of life and medicine, that diagnostics and therapy have limitations, and that predictions of clinical course and outcome may not always be certain. all these may become less or averted once personalized medicine becomes a reality. doctors and patients have to accept the risk of developing a drug reaction (i.e., drug reactions can neither be predicted nor prevented on all occasions) and treatment complications. good communication and understanding of all these aspects is a part of ethics and, if well understood, litigations are less likely to arise. on most occasions, health care professionals are unaware of the importance of ethical practice. it needs to be introduced in education curricula, and training on clinical ethics in health care settings is also beneficial. , medical schools organize clinico-pathological conferences (cpc) where students and faculty interact with each other, but discussions on judgments related to health care or liability cases and ethics are not often presented. interactive programs in medical schools and clinical practices about such issues will help students and physicians understand not only the intricacies of laws related to health care and the shortcomings of health professionals and health systems, but also strengthen their understanding of ethics and laws, improve their practice and standard of care, and minimize litigation issues. medical students are trained and exposed to cpcs regularly during their studies. they are confident about substantiating their statements with evidence. however, most students do not have the confidence to do a clinical audit, to find deficiencies in medical records, to correlate the laws related to patient care, and/or to provide legal support to patients. this is because knowledge about the legal issues is suboptimal among medical teachers, and legal and ethical aspects are not discussed during regular ward rounds or grandrounds, nor are they incorporated into lecture classes. anything that is not learned in medical school is less likely to be remembered and practiced or inculcated. the university of iowa college of medicine is among a relative few to offer separate courses in ethics and law as part of their curriculum. the european society of cardiology (esc) has made recommendations about how to minimize bias in all scientific communications and continuing medical education (cme), and how to ensure proper ethical standards and transparency between the medical profession and industry. , medical education and training do not focus on the intricacies and importance of consultation aspects and, thus, these have to be incorporated into the curriculum. suitable modules have to be prepared for training doctors on the principles of consultation. current medical curricula in india lacks ethics and medical humanities; training programs to acquire such skills were proposed by the medical council of india, but implementing them awaits permission from the indian government. law and ethics support health care professionals and services rendered. the united kingdom's national health service (nhs) has introduced programs to teach and train health care professionals about law, ethics, education, and development (leed) based on surveys. a central thrust of the program was the initiation of an "introduction to health care law and ethics" study day. in this survey, to % of participants rated the educational value as excellent. although the program has now been stopped, there is a need for all to have access to law and ethics. by and large, there is no dispute for dissemination of knowledge on ethics and law to health professionals. some of the subjects that are included in teaching and training for legal medicine and medical ethics are medical humanities, public health policies, the business aspects of medicine, forensic sciences, end-of-life issues, how to care of special patients, the liability of specialties, and medical liability. also such a curriculum should cover hospitals' reputation in medical practice, nursing facilities, managed care organizations, laws, courts and judicial processes, consumer protection acts, human rights, state medical boards, hospital ethics committees, and medical examiners. cardiovascular training should recognize and address ethical issues, the rational use of resources, and conflicts related to end-of-life care. a cardiovascular advance directive should address the deactivation of a pacemaker, use of an implantable cardioverter defibrillator (icd), or a left ventricular assist device (lvad). in addition, cardiovascular clinicians should understand ethical dynamics and equip trainees with the tools of ethical reasoning because the complexity of the specialty continues to increase. À medical students are exposed to the intricacies and interconnections between physiological systems and their influence on living organisms. there are also opportunities available to introduce and discuss ethics and ethical issues and reinforce ethical principles. introduction of ethics in physiology has led to a greater awareness of the importance of ethical issues and are likely to be more widely practiced in clinical practices too. even though doctors make appropriate efforts to treat patients, they have to be trained and retrained about proper documentation from the point of view of litigation; encouraged to record dying declarations and obtain valid consents; and trained on the preservation and confidentiality of medical records, on the avoidance of hiding facts, and on adherence to standard guidelines for therapy. the latter includes selection of the therapeutic agents, methods, and/ or procedures and substantiating written statements if there are any deviations. in addition, guidance is needed for the reporting of illnesses to public health authorities as per the regulations of the county or state and hospitals. a clinical audit is an essential component of clinical governance. it considers procedures adopted to diagnose, methods used to deliver health care and treatment, utilization of resources, and the effect of outcome along with quality of life of the patient. principles for the best practice in clinical audit, published by the national institute for health and clinical excellence (nice), defines it as a quality improvement process that seeks to improve patient care and outcomes through systemic care delivered against explicit criteria and the implementation of change. even though the terms medical audit and clinical audit are used interchangeably, clinical audit has multiple components related to patients, education and training, health care delivery, resources for health, working relationships, and so on. in addition, a clinical audit helps when listening to patients; understanding patients' expectations; deals with evidence-based practice; assists in the development of local guidelines or protocols; minimizes error or harm to patients; and reduces incidents, complaints, and claims. because a clinical audit involves patients and patient-related matters, confidentiality of information has to be adhered to strictly. for the review of case notes during a clinical audit, there is no need for informed consent from patients as long as confidentiality and anonymity are preserved. medical ethics has been incorporated into medical education and training. however, the shortfall in ethics core competencies does not preclude graduation. there is a need for greater integration of ethics in theory and practice. major concerns are how to make a medical faculty impart medical ethics to students of health care sciences. the "cardiology ethics curriculum" at the university of toronto is a useful resource. ethical components are rarely discussed in during ward rounds. teaching ethics should be incorporated into all clinically oriented teaching and training activities. students can also learn ethics through role models and interaction with patients, instead of formal lectures. because medicine and ethics are inseparable, teaching ethics at the bedside becomes essential but is seldom done. there is a need to introduce bioethics as part of the curriculum at all health science education institutions. the complexity of the technology involved in making a diagnosis and therapy requires a careful search for the right answer under some very difficult situations. training on descriptive bioethics using various modern medical education technologies and discussion with fellow doctors, hospital administrators, religious leaders, and social scientists in difficult situations, can help to make policy decisions amicable to the patient, family, and society. achievements in medical practice and health care delivery depend on the status of the medical education system, the nature of medical manpower, economic resources, the health care system, and, importantly, medicolegal law. the quality of medical manpower and medical services are determined by policy, findings, regulatory mechanisms, professional organizations, direction from judiciary, and expectations and participation of the community. a common difficulty in the current medical education system is that it fails to inculcate appropriate skills and competencies to recognize and tackle ethical issues among the learners. although developing an ethics-based medical education system is a challenging task, we have to take initiatives to deal with a variety of issues. a. knowledge in medicine and timely application in a given situation to assess the case at the bedside meticulously with empathy; analysis of clinical issues and challenges, and differentiating one from another with or without the help of laboratory data; application of appropriate specific and nonspecific measures to alleviate the symptoms or to treat cases with currently available guidelines; acceptance of limitations of knowledge and skills, resources, and constraints; arrangement for referral or consultation; provision of follow-up care, rehabilitation services, or welfare program depending on the case; proper documentation, adequate informed consent, continuous monitoring to strengthen physicianÀpatient relationship, patient satisfaction, and quality of life, thereby avoiding any conflicts or liability issues. b. the attitude of health care professionals toward the patients shall be: . receive them with care and concern . respond with empathy . realize the underlying clinical problem(s) and manage with appropriate measures . review the clinical course, therapeutic strategies, and outcome . revise the plan and management with shared decision . seek further help, if needed c. cardiologists should be informed to establish the kind of actions, communication skills, and empathy that are required to build a stronger patientÀhealth care professional relationship, which improves prognosis, treatment efficacy, and therapeutic adhesion. d. cardiac report cards should be developed that incorporate an ethical framework, which can identify points of ethical concern for practitioners, patients, policymakers, and researchers e. the integrity and behavior of an individual physician plays a major role in the prevention of liability cases. professional associations play a major role in the regular monitoring process and for initiating self-regulation of professionals. to provide a written notice of their privacy policy to all those who seek medical care for the first time. patients must be informed of how the institution may use and disclose information. the written notice must describe patient's rights, including the right to access their medical information and their right to provide feedback or complaint, if they believe their rights were violated. the notice shall be in plain language and presented in an understandable manner. an acknowledgment of receipt of the information notice must be obtained from the patient. the institution shall have a close working relationship among medical personnel, legal, and risk management team. the team, through interaction on case by case basis, can acquire a wealth of information, learn, and meet the needs of clinical dilemma, which are evolving constantly. such interactions enhance health care and ensure patient safety, and thereby establish a high standard of care. also, the institution shall ensure quality assurance, organize risk management programs, and conduct routine audits or monitoring as suggested by a specialist's team. laws generally require that therapeutic interventions be done in a reasonable and medically approved manner, preferably based on clinical evidence or standard guidelines. medical staff dealing with cases should remember that the issues raised by any one case are complex and application in a real situation is difficult. hence, staff should review the hospital counsel and the local laws and regulations pertaining to these issues. l. medical records: medical personnel should be trained and motivated for proper documentation, adherence to risk management principles, and entry of every aspect related to the case in the respective medical record. the physician is required to write a medical record that will support the basis for the appropriate medical judgment made. the medical record should reveal supporting clinical data or facts, the patient's history available at that time, hemodynamic status, physical examination, investigation reports, and treatment plans administered. one must remember that hospital records are prima facie evidence. therefore physicians who do not record supporting clinical data and history deprive themselves of a strong "medical judgment defense." moreover, inappropriate entries or markings on the medical record can weaken the defense in a liability case. if any corrections are required in the medical record, the preferable method is to draw a single line over the word or value to be changed; and at the place where such correction is made, initials or signature should be affixed. however, total obliteration of a number or word may indicate that obliteration was done intentionally. quality-assurance reviews of records of eds often reveal inadequate charting by physicians and nurses. a lapse of documentation of patient's clinical condition for hours or more after initial physician and nursing assessment will be utilized by the plaintiffs attorney in a lawsuit to develop the theory that no care was given. the uncooperative acts of the patient and the difficulties encountered in providing care to the patient because of his or her actions should be recorded. poorly written physicians' notes may become an issue in a medical malpractice action and considered a less-than-caring attitude by the doctor. descriptions of a patient's behavior and lifestyles should depict compassion and a professional manner. health care institutions and cardiovascular physicians should realize consumer rights and responsibilities such as information disclosure, choice of providers and plans, access to emergency services, participation in a treatment discussion, respect and nondiscrimination, confidentiality of health information, and complaints and appeals. m. incentives and ethics: incentives, in different forms, have been introduced for various services and are not accessible in health care delivery. incentive mechanisms are based on four types of motives: traditional, selfinterest, affective, and shared purposes. financial incentives have helped to achieve the quality or efficiency of related targets but have potential adverse consequences including conflicts of interest that threaten patientÀphysician trust. the ethical allegations, implications for effectiveness, and mechanisms of different motives were highlighted. incentive schemes based on a robust sense of shared purposes protect and promote physicians' sense of moral responsibilities and ethical standards. these also enable physicians to take ownership of it rather than make them feel it is imposed on them. n. patient-centered specialty practice: as a part of a new phase of health care delivery systems, the national committee for quality assurance (ncqa) launched patient-centered specialty practice (pcsp) in . the objectives of the committee are to reinforce care coordination, improve access to specialty care, reduce the use of unnecessary or duplicate tests, enhance communication, and assess and improve performance. delay in diagnostic investigations, the nonavailability of interventional procedures, recurrent and repeated system failures, and so on, are real aspects of all our daily lives, yet rarely are considered in mitigation. careful documentation of these failures is paramount, if we need to defend ourselves against a system that seeks criminal prosecution or compensation. a legal decision for violation of ethics may lead to loss of status, career, and livelihood. it is worth studying the patterns and prevalence of defensive medicine and the status of lawsuits in different countries to find any economical impacts and adverse effects. patterns of malpractice insurance systems adopted in various countries and the compensation paid to patients should be analyzed and the information shared among health care professionals, community members, and payers, so as to design modalities to reduce expenses. periodic analyses of physician behaviors and attitudes, along with health care utilization and lawsuits, are likely to help professional organizations and health science educators introduce teaching and training modules for reduction in malpractice lawsuits. the consequences of wait time for health care services in terms of quality of life and health care economics should be studied for the effective introduction of remedial measures. the attitude of physicians and their beliefs, preparedness, and experiences related to impaired and incompetent colleagues should be explored, as well as suggestions to overcome them. issues related to devices, drugs, and diagnoses with reference to ethical and legal aspects and alternatives for better treatment of the patient should be analyzed. periodical analyses of judgments related to health care issues, health care professionals, and health services at national and international levels, as well as identification of the causes, to find methods to avert them can be undertaken at educational and industrial levels. the capacity of medical students and practitioners to get informed consent should be evaluated and suitable measures introduced to teach and train them. analyses of curriculum and methods of teaching and training should be undertaken, and medical students should be assessed on their knowledge of ethics and laws. a common curriculum should be introduced so that medical students can be trained uniformly to deliver health care effectively and as expected. moreover, such a curriculum will help patients and practitioners, as patients start moving between countries for medical treatment (medical tourism). the current status of consultation and its impact on the part of referring doctors and their patients have to be studied to find lacunae. suitable modules should be prepared for training doctors on consultation. there are inter-and intracountry variations in one or more components of bioethics, thus the boundaries are disputable. disagreements about the relationship between ethics and law should be addressed. future directions in therapeutics should focus on the role of pluripotent stem cells in cardiotoxicity, the feasibility implications of personalizing health care, and the assessment of myocardial neuronal function. health science research explores basics, epidemiology, risk, prevention, diagnostics and management, financial burdens of disease, and behavioral aspects. each component of health science should focus on ethical aspects before asking for funding. cardiovascular research should produce guidelines on management of end-oflife care, palliative care, and support for patients' decisions to forgo treatment. cardiovascular physicians should prepare and produce modules to facilitate the patient and faculty decision-making process about cardiovascular health. managed care organizations (mco) and cardiovascular physicians should plan and develop guidelines to handle ethical issues or problems related to mco and standard of ethics for hospital administrators and all others involved directly or indirectly with patient care. protocols and algorithms need to be developed to curtail inappropriate prescribing, unnecessary testing, overuse of technologies, diversion of scarce resources, and nonrecognition of complications. the public has realized that "doctors are not always to be trusted, as they have fallen off their pedestal." doctors, therefore, have to remain up to date and demonstrate their continuing competency. currently the duties and responsibilities of doctors have been defined by medical councils belonging to the individual country where they practice. as medical tourism has developed and patients are moving from one country to another for treatment, there is a need to develop an international norm to overcome inter-and intracountry variations. cardiovascular care is increasingly complicated, device-oriented, and expensive, and it requires striking a balance for quality of life and longevity. the modern cardiovascular specialist has to explain these spectra, considering individual patients' wishes and best interests, the maleficence of side effects, and the impact of therapeutic interventions in the larger social context. to achieve these things, physicians should acquire skills in the art of medicine and interact with patients and caregivers with empathy, astute observations, acccurate interpretation of clinical and laboratory data, and application of up-to-date knowledge with evidence and ethics. this can strengthen insight into disease and suffering and provide a means to diagnose, treat, and prevent disease; if followed meticulously and documented sincerely, legal liability is less likely to develop. treatment decisions, in general, should be based on a profound respect for the patient's autonomy, balanced by an appreciation of what may be in the patient's best interest. decision making involves a wide array of personal, professional, institutional, spiritual, and social values. in routine practice, clinical management decisions should be coupled with outcome analyses and guide physicians' approach to best address the needs and expectations of patients. to improve the quality of the physicianÀpatient encounter, we need to develop formal and informal curricula at medical institutions on communication skills and ethics. key learning points g illness remains universal; however, human expectations and experience may vary personally and geographically. cardiopulmonary resuscitation ethics: a response to michael ardagh heart disease, guidelines, regulations, and the law variation in cardiologists' propensity to test and treat: is it associated with regional variation in utilization? professional liability in cardiology analysis of judgments in the practice of cardiology resolved on appeal in spain between and available from: ,www.similima.com/health-insuranceschemes-abused-to-profit-private-providers medical malpractice american college of physicians ethics, professionalism, human rights committee. american college of physicians ethics manual: sixth edition the internal morality of clinical medicine: a paradigm for the ethics of the helping and healing professions clinical ethics revisited: responses the quality of caring patients' perspectives on ideal physician behaviors professionalism, profession and the virtues of the good physician crossing the quality chasm: a new health system for the st century healthcare the ayurvedic way the truth about medical negligence the physician at the movies: seabiscuit. the pharos of alpha omega alpha-honor medical society the physician at the movies: master and commander. the pharos of alpha omega alpha-honor medical society alpha omega alpha physicians' perceptions, preparedness for reporting, and experiences related to impaired and incompetent colleagues medical ethics and the art of cardiovascular medicine what scientists want from their research ethics committee patients' trust in physicians: many theories, few measures, and little data trust in healthcare: an evolving concept uses and misuses of ambiguity: uses of ambiguity the doctorÀpatient relationship: challenges, opportunities, and strategies web-based medical facilitators in medical tourism: the third party in decisionmaking ethical challenges of medicine and health on the internet: a review towards ethical guidelines for dealing with unsolicited patient emails and giving teleadvice in the absence of a pre-existing patient-physician relationship systematic review and expert survey the ethical challenges of ubiquitous healthcare clinical evaluation of cardiovascular devices: principles, problems, and proposals for european regulatory reform deactivation of pacemakers and implantable cardioverter-defibrillators ethical issues and palliative care in the cardiovascular intensive care unit a comparison of general medical and clinical ethics consultations: what can we learn from each other? environmental factors contributing to wrongdoing in medicine: a criterion-based review of studies and cases maximal care considerations when treating patients with end-stage heart failure: ethical and procedural quandaries in management of the very sick futile medical treatment and patient consent knowledge, attitudes and practice of healthcare ethics and law among doctors and nurses in barbados complementary and alternative medicine legal issues in integration of complementary therapies into cardiology practice legal medicine. philadelphia: mosby-elsevier ethical issues in cardiac surgery treating the right patient at the right time: access to specialist consultation and non-invasive testing ethical issues in fetal management: a cardiac perspective how many are underinsured? trends among u.s. adults first, do no (financial) harm the critical role of caregivers in achieving patient-centered care what's wrong with ward rounds health and media: should there be an internal check mechanism in and by media chikungunya epidemic: analysis of reports of a lay press measles vaccination and deaths: analysis of lay press reports ethics for medical educators: an overview and fallacies involving patients in medical education: ethical issues experienced by syrian patients ethical aspects and dilemmas of preparing, writing and publishing of the scientific papers in the biomedical journals fifth report on the provision of services for patients with heart disease defensive medicine in israel-a nationwide survey defensive medicine among high-risk specialist physicians in a volatile malpractice environment public reporting, consumerism, and patient empowerment choosing wisely or beyond the guidelines conflicts of interest in cardiovascular clinical practice guidelines legal issues in emergency management: lessons from the last decade legal medicine. philadelphia: mosby-elsevier competency: what it is, what it is not, and why it matters common law duties of prescribers what consumers want to know about medicines can india stop drug companies giving gifts to doctors? clinical ethics and law interventions expert consensus document on cardiac catheterization laboratory standards update: a report of the american college of cardiology foundation task force on expert consensus documents developed in collaboration with the society of thoracic surgeons and society for vascular medicine patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research low quality and lack of clarity of current informed consent forms in cardiology: how to improve them some limits of informed consent doctors as victims knowledge and practice of clinical ethics among healthcare providers in a government hospital informed consent, privacy and confidentiality practised by doctors of a tertiary care hospital in a developing country it's ethical, but is it legal? teaching ethics and law in the medical school curriculum relations between professional medical associations and the health-care industry, concerning scientific communication and continuing medical education: a policy statement from the european society of cardiology good publishing practice how to teach ethics to those who need to learn putting the humanities back into medicine: some suggestions law and ethics support for health professionals: an alternative model aha consensus conference report on professionalism and ethics ethics and professionalism: can there be consensus? st bethesda conference on ethics in cardiovascular medicine abstract from th bethesda conference on ethics in cardiovascular medicine ethical issues in heart failure: overview of an emerging need ethical dilemmas in device treatment for advanced heart failure management of implantable cardioverter defibrillators in end-of-life care ethics in medical curriculum; ethics by the teachers for students and society the physiologist's ethical dilemmas assessing formal teaching of ethics in physiology: an empirical survey, patterns, and recommendations principles for best practice in clinical audit improving the quality of health care teaching and assessing medical ethics: where are we now cardiology ethics curriculum toronto clinical ethics ward rounds: building on the core curriculum description of an ethics curriculum for a medicine residency program the importance of including bio-medical ethics in the curriculum of health education institutes cardiovascular medicine at face value: a qualitative pilot study on clinical axiology an ethical framework for cardiac report cards: a qualitative study medical assisting: administrative and clinical procedures including anatomy and physiology new regulations on compensation for injury and death in drug trials the clinical establishments (registration and regulations) act. new delhi, india: ministry of law and justice medical negligence liability under the consumer protection act: a review of judicial perspective risk management and legal principles the medical record as a forensic resource ethical physician incentives: from carrots and sticks to shared purpose transforming specialty practice--the patient-centered medical neighborhood the competent prescriber: core competencies for safe prescribing present state and future perspectives of using pluripotent stem cells in toxicology research personalizing health care: feasibility and future implications cardiac neurotransmission imaging principles of ethics and legal aspects have to be incorporated into health science education and discussed at every stage of clinical teaching. g ethics and legal aspects related to emerging areas of health care, such as medical tourism, ubiquitous health care, consumer-driven health care, integration of complementary therapy, and so on, need to be addressed.g curriculum about medical ethics should be included in all aspects of medical education and training, including continuing education. such measures should reduce the possibilities of medical liability cases. key: cord- -xzhoa d authors: zuercher, s. j.; kerksieck, p.; adamus, c.; burr, c.; lehmann, a. i.; huber, f. k.; richter, d. title: prevalence of mental health problems during virus epidemics in the general public, health care workers and survivors: a rapid review of the evidence date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: xzhoa d background: the swift spread of sars-cov- provides a challenge worldwide. as a consequence of restrictive public health measures like isolation, quarantine, and community containment, the provision of mental health services is a major challenge. evidence from past virus epidemics and the current sars-cov- outbreak indicate high prevalence rates of mental health problems (mhp) as short- and long-term consequences. however, a broader picture of mhp among different populations is still lacking. methods: we conducted a rapid review on mhp prevalence rates published since , during and after epidemics, including the general public, health care workers, and survivors. any quantitative articles reporting on mhp rates were included. out of articles screened, a total of were included in this review. results: most original studies on mhp were conducted in china in the context of sars-cov- , and reported on anxiety, depression, post-traumatic stress symptoms/disorder, general psychiatric morbidity, and psychological symptoms. the mhp rates across studies, populations, and epidemics vary substantially. while some studies show high and persistent rates of mhp in populations directly affected by isolation, quarantine, threat of infection, infection, or life-threatening symptoms (e.g. health care workers), other studies report minor effects. furthermore, even less affected populations (e.g. distant to epidemic epicenter, no contact history with suspected or confirmed cases) can show high rates of mhp. discussion: mhp vary largely across countries and risk-groups in reviewed studies. the results call attention to potentially high mhp during epidemics. individuals affected directly by an epidemic might be at a higher risk of short or even long-term mental health impairments. this study delivers insights stemming from a wide range of psychiatric instruments and questionnaires. the results call for the use of validated and standardized instruments, reference norms, and pre-post measurements to better understand the magnitude of the mhp during and after the epidemics. nevertheless, emerging mhp should be considered during epidemics including the provision of access to mental health care to mitigate potential mental impairments. in the past two decades, many countries faced challenges in the realm of major infectious disease epidemics including sars-cov- (peiris et al., ) , swine flu (h n ) (trifonov et al., ) , middle east respiratory syndrome coronavirus (mers-cov) (zaki et al., ) , avian influenza (h n ) (gao et al., ) , ebolavirus (baseler et al., ) , and the recent worldwide sars-cov- outbreak . epidemic outbreaks can result in high case fatality rates and morbidity (van bortel et al., ; meo et al., ) and may require communities to introduce restrictive public health measures like isolation, mass quarantine, and community containment interventions in order to stop transmissions and save lives (wilder-smith and freedman, ) . in consequence, epidemics can cause a high individual and societal burden and can lead to substantial economic loss (smith, ; mak et al., ; van bortel et al., ; dorn et al., ) . while considerable efforts rely on protective and treatment measures such as virus transmission pathways, clinical presentations, and the development of vaccinations, attention is only recently given to short or long-term mental health problems (mhp, hereafter defined as psychiatric/psychological symptoms and mental illness/disorders) (rajkumar, ) that may arise due to the different surrounding consequences of an epidemic in the general public, health care workers (hcw), and survivors of infectious diseases (survivors). epidemics can negatively impact a substantial part of the general public in many different ways such as feelings of a personal threat of being infected (van bortel et al., ; brooks et al., ; chew et al., ) , worries about relatives and family members or losing loved ones (brooks et al., ; chew et al., ; li et al., ) , and protective measures like mass quarantining, the consequences of which leads to individual and social restrictions, and economic loss (brooks et al., ) . as a result, these factors can elicit feelings of anxiety, anger, loneliness, grief, boredom and may lead to serious mhp (brooks et al., ; chew et al., ; fardin, ) . furthermore, the extensive and sometimes controversial mass media coverage during epidemics may amplify uncertainty, loss of control and anxiety (brooks et al., ; fardin, ) . aside from the general public, hcw are prone to different mhp since they usually face an immediate threat of infection through patient contact by working at the epidemic frontline. studies suggest that hcw accounted for up to % of sars-cov- , % of mers-cov, and % of ebola cases in some countries, which frequently resulted in morbidity or even death (chan-yeung, ; suwantarat and apisarnthanarak, ) . in hcw, epidemics often result in difficult working conditions like staff shortage, increased workload (van bortel et al., ) , overwhelming patient numbers (suwantarat and apisarnthanarak, ; van bortel et al., ) , limited safety equipment (van the purpose of this rapid review is to provide an overview of mhp prevalence rates during and after large epidemics of the past two decades. we aim to provide a broad picture of mhp that may arise across a wide range of populations including a) the general public, b) hcw, and c) and virus disease survivors. the rapid and dynamic development of the current situation with sars-cov- requires quick evidence synthesis in order to inform decision-making processes in health care systems. the methodology of this article is based on the practical guide for rapid reviews provided by who (tricco et al., ) . we undertook a review of evidence on prevalence rates during and after epidemic outbreaks on mhp in the general public, hcw, and survivors. the focus was on sars-cov- , h n , mers-cov, h n , ebolavirus, and sars-cov- . pubmed was searched on april , with a broad search strategy (see supplementary table ). any type of quantitative study that provided prevalence rates of mhp in adults (≥ years) during and after epidemic outbreaks, published in english from the year to march , was included. studies that measured mhp rates assessed by psychometrically validated instruments, diagnostic interview, and medical records (chart review), were also included. we excluded studies that used a qualitative design, that did not report on mhp prevalence rates (e.g. providing mean scores only), that did not provide prevalence rates based on previously defined cut-off values for a measurement instrument (e.g. median based sample splitting), and that included mhp measured by single questions/items. studies on common seasonal influenza were also excluded. furthermore, general states like social functioning, quality of life, generic fears (e.g. fear of contracting a virus or worries) or stigma were excluded. based on the titles and abstracts of studies, potential eligible studies of the database search were selected by ca using a co-developed standardized review form to assess study eligibility. the primary reviewer sjz then selected eligible studies after searching the full-text of each potentially eligible publication. doubts and uncertainty in eligibility of a certain study were solved by discussion. an electronic data extraction form was developed to assess the characteristics of the included studies and the reported mhp prevalence rates. data was extracted by sjz, ca, pk, and fh. collected items included: author(s), year of publication, country or region, number of participants, type of epidemic outbreak, time point of assessment, type of mhp assessed, mhp prevalence rate, and assessment method. time point of assessment was coded as: during epidemic/hospital stay, post-epidemic/discharge including one-year follow-up (≤ y), between one and four years follow-up (> - y), or a combination of both if applicable (e.g. for longitudinal studies). mhp were categorized into anxiety, depression, post-traumatic symptoms/disorders (ptsd) or stress, burnout, psychiatric morbidity, and further mhp like hallucinations or insomnia. we used baseline assessment data for intervention studies that provided prevalence rates. data was stratified by the following populations: a) general public including general surveys, b) hcw including all hospital staff, military duty members, and family members as caregivers involved in active treatment or in potential contact with patients, and c) infectious disease . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . https://doi.org/ . survivors (that may include suspected cases in some studies). data quality and strength of evidence was not rated in the current review. all authors who extracted data discussed possible uncertainties with the primary reviewer sjz. included studies varied in assessment of mhp (e.g. questionnaires, diagnostic interviews), mhp instruments with applied cut-off scores, sampling methods and response rates, outbreak-related time points of assessments, and in regional differences in the magnitude/level of affect. due to the approach chosen (rapid review), no metaanalysis was conducted. therefore, a descriptive approach was utilized to synthesize reported mph prevalence rates. if provided, we show mhp rates from a moderate degree of severity as defined by authors within original studies. our pubmed search yielded , articles of which were included in the qualitative synthesis (see figure ). the majority of studies were cross-sectional in design and focused on mhp during sars-cov- (n= ), followed by ebolavirus (n= ), mers-cov and sars-cov- (n= ), h n (n= ), and h n (n= ). about half of the studies in the general public used random sampling, while the majority of articles in hcw and survivors were non-random samples. the vast majority of studies was conducted in china, including taiwan and hong kong (n = ), followed by other countries in asia (n = ), in africa (n = ), and the american continent (mainly canada; n = ), with three studies conducted in europe. we found n= , , and studies that investigated the general public, hcw, and s urvivors, respectively. the vast majority of studies assessed mhp using self-reported questionnaires, while only few used standardized diagnostic interviews. results stratified by general public, hcw, and survivors can be found in tables - . range of prevalence rates across original articles were as follows: anxiety ( . - . %), depression ( . - . %), any anxiety/depression symptoms combined ( . %), ptsd/stress ( . - . %), and psychiatric morbidity ( . - . %). the rates of further mhp included any mental disorder (< . %), alcohol/substance use disorders (< . %), anger ( . - . %), moderate to severe emotional disorder or depression ( . %), intellectual disability ( . %), and psychotic symptoms like hallucinations ( . %). the highest and lowest rates of anxiety were found in mers-cov ( . %), and sars-cov- ( . %), respectively. for depression the highest rates were found in sars-cov- ( . %) and the lowest in ebolavirus ( . %). for ptsd/stress, the highest rates were shown for ebolavirus ( . %), and the lowest in h n ( . %). psychiatric morbidity was highest in sars-cov- ( . %) and lowest in h n ( . %). range of prevalence rates were as follows: anxiety ( . - . %), depression ( . - . %), ptsd/stress ( . - . %), burnout ( . - . %), and psychiatric morbidity ( . - . %). the rates of further mph included any new axis diagnosis ( . %), insomnia ( . - . %), and substance abuse or alcohol related symptoms ( . %- . %). the full range of rates in anxiety were both found in h n ( . - . %). for depression, the highest rates were found in sars-cov- ( . %) and the lowest in ebolavirus ( . %). for ptsd/stress, the highest rates were shown for sars-cov- ( . %) and the lowest for sars-cov- ( . %). highest and lowest rates for psychiatric morbidity were both found for sars-cov- ( . - . %). range of prevalence rates were as follows: anxiety ( . - . %), depression ( . - . %), ptsd/stress ( . psychiatric morbidity was described only in sars-cov- ( . - . %). . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . in this rapid review of original articles we found a wide range of mhp including anxiety, depression, ptsd and stress related symptoms or disorders, psychiatric morbidity, and many further mhp like paranoid ideation, hallucinations, and insomnia that may occur in the general public, hcw or survivors during and after epidemic outbreaks. aside from methodological issues and the large heterogeneity of original studies (e.g. poor validation, different cut-offs for case definition), mhp may be prevalent in all three populations. these problems may be substantial and can persist over time in hcw and survivors more directly affected by the epidemic threat. however, it should be noted that epidemic circumstances can also yield positive impacts on mental health like spending more time on physical activity and taking more care of one's mental health (lau et al., ) . mhp ranged widely both across the general public and in all epidemics, which makes it difficult to estimate the magnitude and associated characteristics that may aggravate mhp. however, many studies investigated risk and protective factors of mhp. although some controversy exists among studies, a higher level of epidemic exposure (e.g. living proximity to epidemic epicenter, contact history to high prevalent virus regions) (lee et al., b; sun et al., ) , hospitalization during epidemic (sim et al., ) , being quarantined (ko et al., ) , or having infected family members (lee et al., a; xu et al., ; cao et al., ) may aggravate mhp. further risk factors include being female wang et al., ; xu et al., ; sun et al., ) , chronic physical illness (cheng et al., b) , poor self-rated health (wang et al., a) , and dissatisfaction with measures controlling the virus . furthermore, many studies reported problems like loneliness, boredom, anger, worries about family members (wang et al., a) , and financial problems or economic loss (chua et al., ; lau et al., ; mishra et al., ; cao et al., ) that negatively interfere with mental health. in contrast, accurate health information (e.g., treatment, local outbreak situation) (wang et al., a) , particular precautionary measures (e.g., hand hygiene, wearing a mask) (wang et al., a) , social support (ko et al., ; lau et al., ; cao et al., ) , and appraisals and coping strategies (cheng et al., b; chew et al., ) may be protective. similarly, hcw and survivors showed a wide range of mental health impacts. however, mhp rates in these populations may be more substantial than in the general public. hcw that were directly involved in patient care (verma et al., ) , working in high risk units and with infected patients (chen et al., ; maunder et al., ; mcalonan et al., ; su et al., ) conscripted workers (chen et al., ) , or that underwent quarantine during outbreak (bai et al., ; liu et al., ) were found to be associated with a higher risk of mhp. furthermore, younger age (verma et al., ; su et al., ) , being single (chan and huak, ; liu et al., ) , fear of adversely affecting relatives (maunder et al., ; mcalonan et al., ) , pre-exposure to traumatic events or history of mhp (su et al., ; lancee et al., ; liu et al., ) were also found to be associated with a higher risk of mhp. in contrast, adequate professional education and training (maunder et al., ; lancee et al., ; tang et al., ) , support from colleagues (chan and huak, ) , appropriate information and communication (directives, precautionary measures, disease information) (chan and huak, . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint ), and altruistic risk acceptance (liu et al., ) were found to be protective. in survivors mhp may be aggravated by a history of mental illness , the fear of permanent damage or death (cheng et al., b; wu et al., b) , longer duration of quarantine (hawryluck et al., ) , having physical late sequelae (pers et al., ) , and impairment of ability to work (lam et al., ) . furthermore, survivors that are hcw were shown to be more susceptible to long term mhp compared to non-hcw survivors (cheng et al., a; lee et al., ) . the methodological characteristics and quality of studies in assessing mhp ranges widely. we found only few studies that did not utilize a cross-sectional design without repetition. further, most cross-sectional studies did not report any comparative data from which the change of prevalence rates due to the epidemic could be estimated. sampling characteristics were also varying. only about half of the studies in the general public were based on representative samples. as many studies were conducted during or shortly after the peak phase of the epidemic, results have to be regarded as acute stress reactions that do not allow for inference of longer-lasting mhp. while some authors used well established and widely used instruments and standardized diagnostic interviews (e.g. ji et al. ( ) or lancee et al. ( ) ), others used instruments with unclear quality (e.g. guetiya wadoum et al. ( )). besides the possibility of biased results, this approach makes it challenging to identify clinically relevant cases. with respect to the application of diagnostic instruments, cut-off values might vary between countries and cultures. therefore, a lack of validated, country-specific, cut-off values of the measurement instruments might be problematic (jalloh et al., ) . as shown by this review, mhp may be prevalent across a broad range of populations. in this vein, clinical monitoring of risk groups that are vulnerable to psychological impairments due to the current sars-cov- epidemic is essential (pfefferbaum and north, ) . pfefferbaum and north ( ) pointed out, that the monitoring of psychosocial needs should assess sars-cov- -related stressors, secondary adversities, psychosocial effects, and indicators of vulnerability. besides others, routine outcome monitoring (carlier et al., ) as a measurement feedback system, apps for (self-)monitoring of mood, sleep-quality, or medication adherence (rubanovich et al., ) , and artificial intelligence predicting relevant psychiatric outcomes (lovejoy et al., ) , are available for public mental health monitoring. in the best case, mental health service providers should be aided by e-monitoring during epidemics. as mentioned above, in research mhp should be assessed by standardized diagnostic interviews or measurement instruments enabling appropriate case detection identifying risk groups in order to inform policy and practice. furthermore, access to mental health services for those in need is paramount during the sars-cov- crisis, especially when social isolation is experienced (wang et al., ) . beside the psychosocial consequences of public health measures such as quarantine (brooks et al., ) , acute viral infection is unknown but likely to be accompanied by substantial neuropsychiatric symptoms (anxiety, depression, and trauma-related symptoms) as a host immunologic response to the infection (troyer et al., ) . mental health care interventions are expected to reduce symptoms such as ptsd (torales et al., ) . however, during epidemic scenarios care needs to be . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . adapted to upcoming circumstances by respective governments in order to prevent or support individuals with mhp (duan and zhu, ) . in epidemic conditions, where consultation in-person is restricted there are important implications for digital health approaches. online psychotherapy and consultation might help to improve access to mental health care, particularly in times of quarantine and isolation (langarizadeh et al., ; tuerk et al., ) . it does need to be highlighted that the effectiveness of online services for the improvement of mental health services requires further assessment (kauer et al., ) . consequently, the outbreak of sars-cov- calls for rapid reports and insights, as well as long-term health service research focusing on both remote and in-person mental health resources during epidemics (starace and ferrara, ; wind et al., ) . working conditions play an important role in mental health. for hcw, protective working conditions such as social support, constructive communication and staff training and education have already been mentioned in some studies (maunder et al., ; lancee et al., ; tang et al., ) . employers should consider strengthening these resources by implementing support systems and coping management strategies. besides such protective factors there might be even health promoting occupational aspects to be considered. for hcw, the intent to help can buffer mental health-impairing consequences (liu et al., ) but might be a rewarding factor in and of itself (de gieter et al., ) . it is also conceivable that enhanced public attention can trigger public appreciation of hcw. furthermore, hcw could move to the political fore promoting improvements in the working conditions. such rewarding aspects should be investigated in future studies. the importance of social support for mental health has been highlighted by several studies (ko et al., ; lau et al., ; cao et al., ) . digital communication with friends, relatives and colleagues might buffer the negative effects of loneliness and separation. although most of the studies have highlighted stressors and protective factors to cope with these stressors, there might even be rewarding aspects in times of an epidemic. some positive mental health-related factors like family support, mental health awareness and lifestyle changes such as time to rest, to relax or to exercise have already been investigated (lau et al., ) . during epidemics, a substantial proportion of individuals might be confronted with altered working conditions like teleworking, which is generally associated with pros and cons for mental health (mann and holdsworth, ) . future studies should examine ways to reduce the negative impact of home-office situations in times of an epidemic crisis. many studies have highlighted the role of timely and adequate information that should be provided (wang et al., a) . epidemics with escalating case numbers and mass quarantine convey the impression of a serious personal threat and increase feelings of anxiety, loss of control and being trapped (rubin and wessely, ) . the extensive mass and social media coverage is associated with public concerns and may contribute to negative psychological effects (rubin et al., ; bo et al., ) . appropriate information and education programs may not only help to decrease anxiety but also benefit in adopting protective measures ). thus, adequate media is essential for the promotion of protective measures (rubin et al., ) . besides the responsibility of (health-) authorities to provide adequate information, it is necessary to understand the development of public attitudes to better target communication strategies, particularly with the rise of fake news and conspiracy theories (atlani-duault et al., ) . furthermore, strengthening health literacy (kickbusch, ) appears to be important in enabling people to evaluate the relevant information. generally, . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint the application of health behavior theories in research of public attitudes and behaviors would enhance the development of public health interventions that address the mental health-impairing processes of an epidemic crisis. addressing the needs of subpopulations in public health policy with regard to the general public, the consideration of subpopulations was mainly neglected. for instance, people with mental illness (holmes et al., ) or children and families that might be victims of domestic violence, particularly in times of quarantine (campbell, ) . also, for the elderly, the effects of social distancing could lead to isolation, loneliness and severe mental health consequences (newman and zainal, ) . it is generally accepted to assume that people lacking resources (such as financial, cultural or social resources) might be more vulnerable within a crisis (hobfoll, ) . given this, future studies should examine mental-health effects for specific subpopulations. this would result in targeted interventions in these populations in addition to general public mental health approaches. an important strength of our study is the inclusion of a broad range of populations that may be affected by mhp during or after an epidemic. this review provides an essential overview of a highly relevant public health topic since the impact of impaired mental health itself on individuals, society and economy can be substantial. are of interest for researchers, practitioners and policy planning (e.g. country specific prevalence rates). limitations may arise from our search strategy since we searched for scientific publication on pubmed and did not screen reference lists of relevant articles. additionally, no quality assessment of the studies was conducted. further limitations arise from the large heterogeneity and methodological issues (see sections of mental health problems and methodological issues in this paper). at the same time, the heterogeneity of integrated studies is an asset, as they offer an extensive perspective on the studied issue. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint in this rapid review of original articles, we found a large range in prevalence rates of mhp such as anxiety, depression, post-traumatic stress symptoms or disorders, during and after epidemics across the general public, hcw, and survivors. mhp might be especially prominent among hcw and survivors that are directly affected by epidemics and face a real threat of infection and difficult circumstances like isolation/quarantine or difficult working conditions. as shown by various original studies, mhp across all populations can be substantially influenced by risk and protective factors, some of which are modifiable like social support and appropriate information by authorities. from a clinical point of view, policy makers and health care providers should be aware of potential short term or even persistent mhp. during epidemics, mental health care needs to be adapted to changing circumstances in order to grant access and treatment to those in need. digital mental health approaches can support access to care for the public. this allows for psychological monitoring and treatment when in-person consultations are not possible. yet, digital health interventions are still in developmental stages and need further assessment. during lockdowns, they seem to be a relevant supplement to the provision of inperson mental health care. furthermore, hcw that often account for a substantial fraction of virus cases need to be supported. however, health authorities and policy makers should keep in mind separating short-term acute stress reactions from long-term mental illness. it is of note that many original studies used different approaches and show methodological diversity in the assessment of mhp, which at least partly explains the broad range of mhp. thus, results should be treated with some caution since a comparison of prevalence rates across studies and assessment of magnitude of mhp is currently not possible. future studies should monitor mhp with standardized methods and apply comparisons with country-specific norms in order to gain a better understanding of mhp, to learn about influential factors, and to better understand how to provide appropriate access to mental health care during epidemics. although, this was out of scope for this review, evidence of mhp in vulnerable populations such as children or people with pre-existing mental illness seems to be scarce and should be covered in future studies. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. dr and sjz contributed to the design of the study, data acquisition, data interpretation, manuscript development and revisions. pk contributed to data acquisition, data interpretation, manuscript development and revisions. ca, fh contributed to data acquisition and manuscript revisions. cb contributed to data interpretation and manuscript revision. al contributed to data interpretation, manuscript development and revisions. all authors approved the final version of the submitted manuscript. no funding no acknowledgements . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . page / is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint bai et al. ( ) taiwan sars-cov- / during ptsd/stress (dsm-iv): % acute stress disorder chan and huak ( ) singapore is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint maunder et al. ( ) canada exposed; non exposed sars-cov- / post > - y ptsd/stress (ies): . % high in exposed; . % high in non-exposed group ptsd/stress (k ): . % high in exposed; . % high in non-exposed burnout (mbi-ee): . % high in exposed; . % high in non-exposed wu et al. ( ) china is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. 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cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) key: cord- -t aqcvu authors: carneiro, vera lúcia alves; andrade, helena; matias, luísa; de sousa, raul alberto ribeiro correia title: pos covid- and the portuguese national eye care system challenge date: - - journal: j optom doi: . /j.optom. . . sha: doc_id: cord_uid: t aqcvu abstract the pandemic of the severe acute respiratory syndrome disease caused by the new coronavirus sars-cov- (covid- ), had profound impact in many countries and their health care systems. regarding portugal, a suppression strategy with social distancing was adopted, attempting to break the transmission chains, bending the epidemy curve and reducing mortality. these measures seek to prevent an eventual national health service over-running, enforcing the suspension of all elective and non-urgent health care. despite the success in so far, there is a consensus on the need to recover the previous level of health care provision and further enhance it. the portuguese national health service, as a public, universal access, health care system funded by the state proved, in this context, its importance and relevance to the portuguese population. however, long standing issues, such as the pre pandemic over long waiting lists for hospital ophthalmology attendance, whose determinants are fully identified but still unmet, emerge amplified from this pandemic. the lack of primary eye care in the national health service is a significant bottleneck, placing a huge stress on hospital-based care. an exclusive ophthalmologist’s centre care was over-runned before pandemic and will be even more so. the optometrist’s exclusion from differentiated, multisectoral and multidisciplinary eye care teams remains the main hurdle to overcome and insure universal eye care in portugal. national health service highlights the consequences of an overcome model. universal eye care more than ever demands an evidence-based, integrated approach with primary eye care, in the community, on time and of proximity. la pandemia del síndrome respiratorio agudo grave causado por el nuevo coronavirus sars-cov- (covid- ) ha tenido amplias repercusiones en muchos países y en sus sistemas sanitarios. en portugal, se ha adoptado una estrategia de contención basada en el distanciamiento social, con la cual se ha intentado cortar las cadenas de transmisión, frenar la curva de la epidemia y reducir la mortalidad. con estas medidas se trataba de evitar un eventual desbordamiento del servicio nacional de salud y se imponía la suspensión de toda la atención médica programada, que no fuera urgente. a pesar del éxito logrado hasta este momento, existe consenso sobre la necesidad de recuperar el nivel anterior de atención médica y fomentar su mejora. el servicio nacional de salud de portugal, como sistema sanitario público y de acceso universal, a cargo del estado, ha demostrado, en este contexto, su importancia y pertinencia para la población portuguesa. sin embargo, los problemas que acarrea desde hace mucho tiempo, como las largas listas de espera, anteriores a la pandemia, en la asistencia oftalmológica hospitalaria, cuyos factores determinantes están completamente identificados, pero que continúan sin solución, se han visto agravados a resultas de esta pandemia. la falta de atención primaria oftalmológica en el servicio nacional de salud es un importante cuello de botella, que ejerce una enorme presión en la atención hospitalaria. la atención de un centro exclusivamente oftalmológico estaba desbordada antes de la pandemia y lo estará aún más después de esta. la exclusión de los optómetras de los equipos de atención oftalmológica diferenciados, multisectoriales y multidisciplinarios continúa siendo el principal obstáculo que debe superar y asegurar la atención oftalmológica universal en portugal. el servicio nacional de salud hace hincapié en las consecuencias de un modelo superado. la atención oftalmológica universal exige, más que nunca, un enfoque integral basado en la evidencia para abordar la atención primaria oftalmológica en la comunidad, puntual y de proximidad. covid- , atención oftalmológica, portugal, acceso universal, optómetras, oftalmólogos early this year it became obvious that the severe acute respiratory syndrome disease caused by the new coronavirus, sars-cov- , (covid- ) would translate into a pandemic, already having almost million infected people identified and more than thousand deaths. in addition to the symptomatology associated with the respiratory and digestive systems, ocular symptomatology such as hyperemia and conjunctival congestion are also identified. however, more evidence is needed to determine the ocular effects presented in covid- or its ability to first suspect covid- . since the expression of the receptor for sars-cov- , an angiotensin-converting enzyme (ace ), , seems to be concentrated in type ii alveolar cells, a rapid and unique transmission by infected individuals through droplets in contact with deep lung tissue was speculated. however, and as the airways where type ii alveolar cells are located are not reachable by respiratory droplets with a diameter greater than micrometers, seems likely that at least the most severe cases of covid- with viral pneumonia result from airborne events. the continuity between the ocular tissues and the upper respiratory tract, as well as the existence of ace receptors on the ocular surface, makes eye protection indispensable in the provision of proximity health care, less than two meters away, through protective goggles or face shield, in addition to the normal personal protective equipment that includes gloves, medical mask and gown. , as measures to prevent the spread and contagion by the sars-cov- in portugal, it was decreed schools' closure on march and the emergency state declaration, with border control and closure, on march . portugal has thus tried to adopt a suppression strategy, that is, an attempt to break the transmission chains, slowing the epidemy propagation and reducing the incidence to the smallest possible. a zero-growth rate in the covid- incidence is compatible with the effectiveness of measures of distancing and social isolation, as well as of the measures of hygiene and respiratory etiquette. still, the growth in the prevalence continues, and although the data supports the claim that the incidence peak has already been reached, it is yet to be reached the prevalence peak in portugal. despite variations in duration, size and phase, the european context is of community spread and virtually all european countries are currently in the community transmission mitigation phase. the identified limitations of the human, material and organizational resources of the portuguese national health service (serviço nacional de saúde) and the alarming expectation of an eventual national health service over-running by a significant number of infected people, implied the suspension of all elective and non-urgent health activity, namely in the primary care level, scheduled hospital interventions and community care, which adds to the decrease of the urgent and emergent activity care due to the fear of contagion felt by the patients. the current strategic objective of the portuguese health general-director is to mitigate the risk to public health, patients, and professionals, and at the same time to avoid the national health service collapse. still, despite how worrying public health situation is, there is a consensus on the need to recover the previous level of health care provision, otherwise the effects of other untreated illness can be even more harmful. nevertheless, a possible second peak is a circumstance to be considered, as a result of the relaxation of the measures to restrict circulation, internal and external, and less social distancing. it is also important not to lose sight of the fact that the different national health services in all countries have been under enormous pressure, not because of the relatively low lethality rate, but above all because of the very high incidence of covid- on the population. italy's experience, for example, supports the idea that in the case of full use of intensive care resources, the lethality rate increases significantly. therefore, prudent and informed planning is essential to contain contagion, safeguard health services and consequently limit the lethality rate. until group immunity is achieved in portugal, either through vaccination or through possible acquired immunity, the recovery of health care provision must be framed in the current epidemic situation with community spread contagion, as well as contagion by foreigner source. this implies adjusting organizational and clinical management procedures, individual therapeutic and diagnostic equipment, physical spaces, and management of the circulation of patients and professionals in the spaces of access to the health care facilities. in the eye care provision, protection measures, procedures, and personal protective equipment, acquire special importance in this new context. similarly, this pandemic situation is further evidence of the direction that health services should follow, focusing on a community and proximity-based care. an approach where primary, timely and preventive care is provided, enhances the first contact between the health provider and the community, in an integrated care provision through all the different health care levels. thus, it would be possible to filter what can be attended and solved in primary eye care, and leaving the necessary curative and reactive approach to highly specialized, secondary and tertiary care, safeguarding physical and human resources. the differentiation and separation of the current health organizational model, in a real primary or community, secondary or hospital and tertiary care, duly established and communicative bottom to top, would also constitute a barrier in the propagation and contagion of conditions such as covid- , without the need to completely suspend the provision of health care. it would allow the sorting patients within the community and in a proximity way, without the typical agglomerations of hospital services and observing the limitations of travel within the system and contact inherent. the significant financial burden borne by the state, inherent to the purely specialized secondary and tertiary services, would also be reduced. by all these arguments, it is important to note that this is a moment of change and to create the formal rationality that the national health service has just suffered a temporal division: the prepandemic era and the post-pandemic era. looking on the positive side, the national health service as a public, universal access, health care system funded by the state proved, to those who still had doubts, its potential and responsiveness when mobilized and provided with the appropriate resources and organization. the essence of the national health service, its mission and its values serve a greater purpose and demonstrate in this context its importance and its relevance to the society, assuming itself as possibly the most important organization at national level. and that is precisely why it is important to highlight the need to provide access to a broad scope of health care services within the national health service, to ensure its functionality, its safety, its effectiveness, and its efficiency. also, national health service should be reformed, reorganized, complemented, and adapted to population needs, which are dynamic and changeable over time. all of this, considering differentiated approaches according to population demographic evolution, epidemiological data, and scientific evidence, focusing care on patients and population needs. the lack of primary eye care in the national health service and inadequate planning of the eye care workforce are the central constrains, highlighted during and pos pandemic crysis. , also, it is pointed that about sixty percent of the portuguese eye conditions could be manage at primary care level, since they are technical simple and would free hospital resources from less differentiate tasks. the portuguese ophthalmologist-only eye care model is known to be ineffective and expensive use of eye care resources, that could be allocated and better used in surgery and pathology management. a comparison with the uk ophthalmologist-optometrist model clearly evidences portuguese shortcomings. as a result of not implementing the recommendations of the world health organization, good practices and scientific evidence, a difficult pre-pandemic situation suddenly escalates to a defiant pandemic and post-pandemic situation. it is enough to consider the elderly on their visits to the hospital to obtain a simple prescription for glasses, knowing that they are in the age group with higher prevalence of refractive errors and also have higher risk of exposure to contagion, and risk of death outcome. the approach to eye care provision must follow the same orientation of the other health care, differentiated by levels, primary and secondary, integrated in the community, protecting, and promoting the eye health. eye care at primary level should be evidence based, preventive and proactive, contrary to the curative and reactive action of secondary and tertiary care. [ ] [ ] [ ] the same recommendations are made by the world health organization and for which there is a global action plan. , the creation of primary care platforms for the eye care, properly integrated in the current primary care network, taking advantage of the existing logistics and material resources and using the highly qualified human resources trained nationally by portuguese universitiesoptometristsis one of the proposed solutions for solving a chronic national health service problem and that the pandemic scenario has accentuated. lourenço and pita-barros study concludes that it will suffice to address in primary eye care only twenty-five percent of all references to secondary hospital specialty of ophthalmology to immediately eliminated waiting lists. this would provide resolution of primary care conditions, as are refractive errors, accommodative, vergence and oculomotor dysfunctions, as well as the screening and follow-up of pathologies such as retinopathies, would allow a screening of primary care users and immediately solving the problem of most patients. providing primary eye care from the perspective of proximity and community would minimize the patient travel and waiting time to access the national health service, making it safer, more effective, and more efficient. a recently published study shows that the delay in the use of primary eye care provided by optometrists is associated with a greater probability of resorting to general practitioners, as an indicator of missed opportunities to detect potentially serious eye conditions. it is emphasized that this study reflects on the pre-pandemic period, so the consequences during and postpandemic are expected to be substantially greater. the impossibility of maintaining current practices regarding eye care provision challenges in the portuguese national health service, imposes a paradigmatic shift that breaks with previous overcome practices and with the permanent insufficiency in the provision of this care. more than implementing a better cost-benefit practices, which is consensually assumed and accepted, a change is required that protects public health, patients and professionals, that provides care where is needed, when is needed, with reduced contagion exposure and effective, simple and direct response to the patient needs. scientific evidence, recommendations of relevant organizations and entities and good practices , [ ] [ ] [ ] , as well as the analysis of socio-economic impact , are clear and point to the same solution: a national health service should be based on a solid primary, differentiated, multisectoral and multidisciplinary care, and with regard to primary eye care, should be provided, by definition, by the optometrist. more important than the reform of the national health service, which has proved to be a matter of significant challenge, this period requires a reform of thought and the disconnecting of obsolete and ineffective practices. with regard to the eye care, who timeline -covid- clinical characteristics of coronavirus disease in china discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin functional assessment of cell entry and receptor usage for lineage b βcoronaviruses, including -ncov single-cell rna expression profiling of ace , the putative receptor of wuhan -ncov. biorxiv transmission of influenza a in human beings seasonality of respiratory viral infections dgs. orientação / : prevenção e controlo de infeção por novo coronavírus dgs. novo coronavírus | covid- utilização de equipamentos de proteção individual decreto n. o -a/ -diário da república n. o / , o suplemento, série i de - - world health organization. declaração de alma-ata estudo para a universalização de cuidados de saúde da visão em portugal estratégia nacional para a saúde da visão ophthalmologists and optometrists -interesting times? a reforma dos cuidados de saúde primários e a reforma do pensamento. rev port clínica geral who. primary health care: now more than ever essential components of primary eye care world health organization. who | universal eye health: a global action plan - . world health organization delayed attendance at routine eye examinations is associated with increased probability of general practitioner referral: a record linkage study in northern ireland world health organization towards a better world -optometry's role" -world council of world health organization. strategies for the prevention of blindness in national programmes:a primary health care approach and anticipating the difficult post-pandemic scenario, only a solution that takes advantage of the human and material resources already existing in the country and that does not submit to the economic and corporate interests is acceptable. key: cord- -su uibmi authors: smith, maxwell j.; upshur, ross e. g. title: ebola and learning lessons from moral failures: who cares about ethics? date: - - journal: public health ethics doi: . /phe/phv sha: doc_id: cord_uid: su uibmi the exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. despite the persistence of the ebola virus disease (evd) outbreak in west africa, it seems that the ebola ‘lessons learned’ exercise is now in full swing. on our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. in this article we argue that, despite not being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. we cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice. the exercise of identifying lessons in the aftermath of a major public health emergency, and then of course actually learning those lessons, is of immense importance for the improvement of global public health emergency preparedness and response. for instance, such exercises were carried out by local, national and global health authorities following the outbreak of severe acute respiratory syndrome in - and the h n influenza pandemic in - (health canada, world health organization, a; campbell, ; chan, a; hine, ; public health agency of canada, ; world health organization, ) . notwithstanding some substantive disagreement on the lessons themselves, there is no doubt that there are lessons to be learned from these crises, and, apart from what the most steadfast cynics might argue, that we are capable of learning at least some of them. despite the persistence of the ebola virus disease (evd) outbreak in west africa, it seems that the ebola 'lessons learned' exercise is now in full swing. a search of the pubmed database conducted on july , using a combination of the terms 'lesson*' or 'learn*' and 'ebola' for literature published after march , retrieved results, with many more expected to be added in coming months. hundreds of additional 'lessons learned' articles and entries in popular media can be returned through a similarly constructed web search. the lessons that have been articulated thus far vary widely in content and scope and permeate numerous domains, from lessons for global outbreak surveillance and governance (kalra et al., ; gostin, ) to lessons for the livestock industry (clarke, ) , the role of outer space (asrar et al., ) and investing in ebola drug and vaccine stocks (ward, ) . many who have weighed in thus far have framed the exercise as 'lessons learned' (e.g., 'what ebola has taught us'), as if the learning has already occurred. in the sense that learning can minimally be understood as the acquisition of knowledge, there is no doubt that learning has commenced; however, the act of identifying failures and areas for improvement, while crucial, does not necessarily constitute a meaningful cultivation of such insights. therefore, we suggest that it is perhaps more accurate to frame this initial exercise as 'lessons identified', which leaves outstanding the task of understanding and embodying those lessons, their implications and how they ought to be translated into actionable guidance and ultimately constructed or incorporated into institutional structures, policies and practices. while the initial exercise of identifying lessons is not insignificant, the tasks required to learn those lessons in a robust and meaningful manner presumably involves disproportionately more effort by the numerous and varied organizations and institutions that participated in the response. learning these lessons such that we are then able to improve upon the prevention of, response to, and recovery from the evd outbreak in future scenarios will ultimately require the interrogation and understanding of not just where and how the prevention, mitigation and response to the evd outbreak was inadequate, but also why these inadequacies existed and what factors created, and may perpetuate, these failures. so, what then is to be made of these emerging 'lessons learned'? are common themes emerging? who is responsible for learning the lessons? do the lessons concern the fundamental factors contributing to our failures or only those factors that can be remediated given current stakeholder interests, power relations and institutional structures? are the lessons novel or at all insightful? if lessons emerging from this crisis resemble those that we were meant to learn in the wake of previous outbreaks (e.g., heymann et al., ; dickmann et al., ) , is there reason to believe that the 'wake-up call' this outbreak purportedly serves will somehow be different in catalyzing change? these are questions that must be answered if the lessons learned exercise is to impart useful knowledge, guide our learning process and ultimately inform the modification of policies and practices in global outbreak prevention, preparedness, response and recovery. on our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. in this article we argue that, despite not being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. as mentioned, there have already been considerable contributions to the ebola 'lessons learned' exercise, and there are sure to be many more. indeed, the most important lessons may only be exposed after the outbreak has finally ended. thus, it would be foolhardy at this point to attempt any sort of summative assessment. for the purposes of the arguments we would like to make in this article, it is not necessary to synthesize and package the lessons that have been proffered thus far in an exhaustive and systematic manner. doing so would be critical to ensure that important lessons for future efforts are not neglected, but this is not our ambition. rather, the purpose of this section is illustrative: to get a sense of the content and scope of emerging 'lessons learned' that have been advanced by key players in the global response to the evd outbreak in order to emphasize the inherently ethical nature of many of these lessons. acknowledging the ethical underpinnings of the lessons from this ebola outbreak should be considered a prerequisite for confronting and envisaging the moral pathways we must take to learn from past deficiencies. to get a sense of the lessons emerging, we looked to key players in the global evd outbreak response and recovery and to the global health community more generally who had published documents or statements containing lessons learned, or lessons to be learned, from the evd outbreak. 'key players' included the world health organization (who), médecins sans frontières (msf), united nations (un), bill and melinda gates foundation and others. table names the organizations and documents reviewed in our analysis, in addition to some of the key lessons identified therein. there are numerous others who have contributed lessons to this expanding corpus, and other important players will surely make valuable future contributions; however, we believe the lessons reviewed here paint a sufficiently representative picture suitable for our purposes. an analysis of these documents resulted in the generation of seven cross-cutting themes representing major trends in the lessons identified. they are briefly presented here. the first theme, which was central to all documents, is that health systems are fragile and must be strengthened if we are to prevent and successfully mitigate future outbreaks of this kind. there was consensus that the evd outbreak was not quickly contained due to the fact that health systems in affected countries were dangerously under-staffed, under-resourced and poorly equipped to carry out fundamental public health activities. this leads into the second theme. the second theme is that surveillance and response capacities must be improved locally, nationally and internationally. the who, its member states and the the needs of patients and communities must be placed at the core of any response. trust must be restored at the community level. the who lacks the capacity and expertise to respond to epidemics. hard questions must be confronted by member states and major donors in order to set who priorities. there was almost no information sharing for tracing ebola contacts between the three most affected countries. samples of human tissue, blood and semen have been taken from patients and dead bodies and shipped around the world. outcomes of r&d should be a global public good. there is a need to support strong r&d efforts and ensure that the fruits of innovation are fit for the affected countries, and are equitably and transparently shared. lack of available treatments for infected staff, coupled with the high mortality rate, created fear among staff. there was a tension between curbing the spread of the disease and providing the best clinical care to each patient. existing institutions, health systems and governance systems were fragile. what was considered 'normal' before the crisis was unsustainable over the long term. there is limited capacity of national and sub-national systems in the face of complex and novel challenges. the poor state of liquidity in the nations' banks limited formal education, illiteracy and inexperience with formal financial services pose challenges. pre-existing low levels of trust in state institutions hampered the response. early recovery interventions should ensure that local economies continue to function, that affected persons have jobs and livelihoods and that health systems rebound. supporting peace-building and social cohesion is a key component of the recovery process. lack of knowledge of the geography, poor access to basic services by the population and population-movement patterns prevented responders from factoring this into response planning at an early stage of the outbreak. a communication gap between governments and communities undermined the efficacy of the emergency response. investment in preparedness is key. the next epidemic-lessons from ebola (new england journal of medicine, april ) (gates, ) health systems must be strengthened. an adaptable international funding system and approval process for diagnostic tests, drugs and vaccine platforms must be developed. global community in general are ill-prepared for a large and sustained disease outbreak. both novel and existing diseases emerging in new contexts must be treated with humility, and response efforts to contain and mitigate their effects must be swift. surveillance systems with strong regional networks, as well as early warning and response systems for outbreaks, must be improved. greater surge capacity in terms of both human workforce and resources at the regional, national and international levels ultimately contributes to a flexible, rapid and effective response. as such, outbreak prevention, preparedness and response must be kept at the top of national and global agendas, and must not slip as it has in recent years. the international health regulations, and in particular the capacity to assess, plan and implement preparedness and surveillance measures, internationally and locally, must also be strengthened. establishing robust health systems and implementing improved surveillance and response systems were identified within these documents as necessary conditions to better protect global health, but it was widely recognized that these steps alone are not sufficient. fear, panic, denial and mistrust/distrust led to the rejection of public health interventions in many instances during this evd outbreak. it should not be surprising, then, that the third theme emerging among the lessons is that community engagement and building trust are essential for successful global public health emergency preparedness and response. it was demonstrated that communities were capable of changing their approach to the disease (e.g., burial practices) when involved in planning. the needs of individuals and communities must be placed at the core of outbreak response, and this can only be accomplished by engaging with affected communities at every turn: in prevention, preparedness, response and recovery. accordingly, the fourth theme is that communications must be improved. both risks and needs must be communicated early, clearly and transparently. consistent, coordinated and transparent messaging will help to build and retain trust, which will facilitate a more effective outbreak response. involving communities and their leaders in communications is also essential. the previous four themes are imperative, and the fifth theme recognizes that achieving these goals is all for naught if they are not achieved universally. the fifth theme is that the global surveillance and response system is only as strong as its weakest link. shared vulnerability to infectious diseases requires shared responsibility, which necessitates collaboration and the sharing of resources and information, including data generated from surveillance, contact tracing and research. in recognition of the immense challenges of successfully coordinating and implementing these lessons, the sixth theme concerns global governance. an effective and rapid response will not take place without leadership at the international, national and local levels. this links back to the importance of involving communities and their leaders in decision-making. organizational and governmental efforts must utilize partnerships and coordination, and must ensure that accountability mechanisms are built in. absence of these mechanisms undermined people's trust in public health services and plans must be developed for effective communication to counter confusion and panic. early warning and response systems for outbreaks must be improved through the improvement of disease-surveillance and laboratorytesting capacity, whose data must be made publicly available. rapid deployment capacity and coordination for response must be improved, and should include a range of stakeholders including community leaders. a the lessons identified in this table are simplified for the sake of clarity and presentation. furthermore, this table does not list all lessons found within these documents, as this would be unwieldy. readers are encouraged to consult the documents/sources listed for a more robust reading and understanding of lessons proffered. ultimately hindered health care utilization during the evd outbreak. the seventh and final theme is comparatively longerterm in its reflection, indicating that market-based systems do not deliver on commodities for neglected diseases. this means that incentives are required to encourage the development-the routine development-of new vaccines and therapies for diseases that disproportionately affect the worst off or are not immediately profitable. this relates to the notion of shared vulnerability and shared responsibility. we must therefore confront difficult questions about how governments and organizations fund and set global health priorities. beyond having the means to develop such medical products, the political will is also crucial to put knowledge into practice. it will be clear to anyone minimally familiar with public health ethics, and infectious disease/pandemic ethics in particular, that the lessons and themes described above are steeped in ethics; they concern values, wade into areas where well-established value-conflicts exist and ultimately involve questions of, and 'insights' into, what is morally right and wrong. indeed, beyond these organizational 'lessons learned' documents there have been several recent contributions to the bioethics literature on ethical issues and learnings from this evd crisis (donovan, ; kass, ; schuklenk ; upshur, ; benatar, ; presidential commission for the study of bioethics, ). yet, explicit attention to the ethical character of the evd lessons and the normative challenges that will invariably exist in correcting our failures in the future is either lacking or altogether absent in the reviewed organizational 'lessons learned' documents. there is no affirmation that many of the failures, as well as the improvements required to redress them, require the embrace and promotion of ethical values that may not yet be embodied by leading actors and organizations operating in global health (benatar, et al., ; benatar, ) . for instance, of its pages, not a single reference is made to 'ethics' in the final report of the world health organization ebola interim assessment panel, nor is there an explicit acknowledgment of the value-laden and rigidly contested nature of global health decision-making and activities (world health organization, a). furthermore, in these documents there is no recognition that many if not all of the themes identified above have been previously identified as important ethical lessons for outbreak preparedness and response. indeed, these lessons reflect ethics knowledge that has been promulgated in various ethics guidance documents for outbreak/pandemic planning and response (even within the organizations sampled) (kass, control and prevention, ; calain et al., ; world health organization, ). the one exception among the documents reviewed was found in the joint un, united nations development programme (undp), world bank, european union (eu), and african development bank ( a) document, recovery from the ebola crisis, which states that '[t]he recovery process is an opportunity to bring issues of governance and ethics to the negotiation table so that recovery efforts are prioritized according to the needs of the most vulnerable and the most affected, including of children, who, by definition, are not organized to lobby for themselves' (p. ). while ethics should be prominently considered in prevention, preparedness and response in addition to the recovery process, we agree that now is an opportune time to bring issues of ethics to the fore. we can begin by emphasizing the ethical nature and parameters of the lessons emerging in these documents. that health systems in resource-poor nations are fragile, and particularly fragile in the face of outbreaks (theme ), is not a terribly insightful lesson-it is one that is routinely taught in global health (travis et al., ; marchal et al., ; world health organization maximizing positive synergies collaborative group, ; balabanova et al., ; jonas, ; world bank, ) . a critical reframing of this lesson is understanding why health systems are fragile in many counties; that is, what factors have led to, and will likely perpetuate, their fragility? the answer to these questions requires careful examination of the social, political and economic determinants of health systems' fragility, which is where remediation should be primarily (but not solely) focused if substantial and sustainable change is to be achieved (un platform on social determinants of health, ; benatar, ) . there is a voluminous literature theorizing and empirically exploring the myriad causes of health system fragility in different states, but it suffices here to reiterate that health systems are political and social institutions (world health organization, b) , and therefore their fragility should arguably be considered a symptom of many separate, but mutually reinforcing, moral failures stemming from global injustice, inequitable global health priorities, inequitable international agreements and institutional structures and a lack of global solidarity (ruger, ; gostin, ) . identifying health systems fragility as an area in need of redress for the purposes of global public health emergency preparedness and response carries the risk of focusing myopically on each systems' fitness for outbreak management. instead, examining and seeking to redress health systems fragility beyond its role as a threat to global security, but rather as an obstacle to well-being and a failure of global health justice, may be what is required to address these failings in a substantial and sustainable manner. however, this requires significant political will and a challenging reorientation for sovereign nations, multinational corporations and international agreements toward addressing the fundamental health needs of those most vulnerable populations in our global community; in short, a new paradigm for global health governance (theme ) (benatar et al., (benatar et al., , ). this will not occur without explicitly acknowledging the moral character of these failures and the values that must motivate and guide future global health activities (ruger, ; benatar, ) . if accomplished, though, this should involve a shifting of global health funding priorities and mechanisms that could in turn address the scope of other lessons, such as the creation of universal accessible primary care systems integrated with public health, which will aid in the development and effective delivery of new vaccines and therapies for diseases that disproportionately affect the worst off (theme ). even when robust health systems infrastructures exist, it is certain that improvements in essential public health functions like outbreak response capacity are still required to address global outbreaks of the magnitude seen in this evd crisis (theme ). as such, any effort to improve global outbreak response capacity is laudable. though, there is a potential for dissonance between theme and theme . if the global community is willing to spend over $ billion usd on the ebola response (save the children, ; united nations development programme, a), we ought to also be willing to commit the equivalent (or more) on health systems improvement, which will act to prevent such large-scale outbreaks from ever occurring in the first place. if plans are now underway to commit a hitherto unknown amount of money to the improvement of early outbreak warning systems, rapid outbreak response capacities and international structures and programs for global outbreak response, will a commitment also be made to spending at least as much on health systems improvement in developing countries? a relevant and prescient ethical learning followed the severe acute respiratory syndrome (sars) outbreak in : the surveillance responsibilities of individual countries may be beyond the capacity of many developing countries. these countries are being pressured to improve their existing surveillance infrastructure. however, doing so may divert resources from areas in which needs are much greater in order to achieve goals that are more in the interest of developed countries. developed countries must be aware of this trade-off and take measures, most suitably in the form of increased investment, to ensure that enhanced surveillance does not occur at the expense of managing the multitude of ongoing public health threats many developing countries face. (university of toronto joint centre for bioethics, : ) renewed commitments to improve global outbreak response capacities must not come at the expense of abdicating our arguably prior moral responsibility to prevent these outbreaks and their tendency to decimate the health of vulnerable populations. while this ebola outbreak and past outbreaks of other infectious diseases have attuned our attention to numerous deficiencies in the technical and operational aspects of outbreak preparedness, response and recovery, the failure to build robust health systems, strengthen resiliency (particularly in the relation between primary care and public health) and establish adequate mechanisms to prevent outbreaks from occurring should represent a moral failure to act (selgelid, ; faden, ) . the lesson, if acknowledged and framed in this way, suggests that our moral outlook must change if we are to position ourselves to prevent and adequately prepare for these crises. this is not to suggest that we can altogether prevent or become immune to outbreaks. rather, it is a claim that our perpetual surprise when deadly outbreaks emerge (often in the worst off corners of the world) reflects our failing of humility and inability to acknowledge history. it suggests that we are happy to recurrently receive the 'wake-up call' provided by global outbreaks but that we are reluctant to answer it. bill gates echoed the thoughts of many others when he stated that '[p]erhaps the only good news from the tragic ebola epidemic. . .is that it may serve as a wake-up call: we must prepare for future epidemics of diseases that may spread more effectively than ebola' (gates, (gates, : . again, following the outbreak of sars a similar sentiment emerged: 'the sars outbreak sounded a dramatic wakeup call about global interdependence and the increasing risk to global human security from the emergence and rapid spread of infectious diseases' (singer et al., (singer et al., : . middle east respiratory syndrome coronavirus, h n and h n influenza, emerging pathogens with antimicrobial resistance and many other threats have sounded similar wake-up calls (world health organization , c . the need to correct our moral failures-to invest in global health such that the emergence of outbreaks is less frequent rather than merely increasing capacity such that we can respond more effectively when they do emergeshould be recognized as an ethical lesson of this outbreak. this is a lesson we repeatedly have the opportunity to learn but have as of yet largely failed to heed. in one of the few examples where lessons learned from this evd crisis referred explicitly to the need for a shift in moral attitude, the world health organization ebola interim assessment panel stated that '[w]e have learned lessons of solidarity. in a disease outbreak, all are at risk. we have learned that the global surveillance and response system is only as strong as its weakest links, and in an increasingly globalized world, a disease threat in one country is a threat to us all. shared vulnerability means shared responsibility and therefore requires sharing of resources, and sharing of information' (theme ) (world health organization, a). those familiar with the public health ethics literature will recognize the centrality of solidarity as a central value in public health and to pandemic preparedness and response in particular (kenny et al., ; prainsack and buyx, ; dawson and jennings, ; national collaborating centre for public health policy, ; thompson et al., ) . after sars (and surely before as well), it was recognized that pandemics can challenge conventional ideas of national sovereignty, and that traditional values of selfinterest must be suppressed in order to protect global health (kotalik, ; the lancet, ; world health organization, a; có rdova-villalobos et al., ; kenny et al., ; buse and martin, ) . indeed, very similar language to that found in the ebola 'lessons learned' documents has been used to advocate for a shift in the global health paradigm in response to the hiv/ aids pandemic ('the movement must continue to innovate and press for a more clearly defined and deeper commitment to shared responsibility and global solidarity among countries and development partners' (buse and martin, : )), the sars crisis ('protecting global health requires governments around the world to show solidarity and to be open and transparent in the way they carry out health protection responsibilities' (university of toronto joint centre for bioethics, : )) and the - h n influenza pandemic ('an influenza pandemic is an extreme expression of the need for solidarity before a shared threat' (chan, b) ). the emphasis on the common and collective good that is at risk in pandemics is in fact at the very center of the relational public health ethics perspective (kenny et al., ) . the importance of solidarity has even been translated into guidance for how to actually realize ethical requirements in outbreak preparedness and response, such as for data and tissue sharing during a global infectious disease outbreak (langat et al., ; crowcroft et al., ). yet, regressions on these ethical lessons appear to have occurred with little controversy during the evd outbreak; travel bans and restrictions, trade restrictions, limited data and resource sharing and other practices geared toward protecting national selfinterest were again adopted rather than accepting shared responsibility (world health organization, a). this calls into question whether lessons of solidarity have been, or will be, learned, simply based upon a revived recognition of our shared vulnerability. rather, the incorporation and realization of solidarity in global public health emergency preparedness and response requires the embodiment of solidarity in the global health paradigm itself. this requires explicit reflection on the ethical parameters and obligations of different global health actors, which must be institutionalized by robust structures and processes for governance and accountability. action on these ethical lessons requires an acknowledgement of our fundamental moral obligations and subsequent reflection on how they ought to translate into policy and practice. other lessons, while still having moral bases, may at first seem considerably more straightforward as they pertain to particular tools considered necessary for effective outbreak management (e.g., community engagement and risk communication). what is important to note, though, is the centrality of trust to these lessons and the effectiveness of these tools. for instance, the who leadership statement on the ebola response and who reforms stated that a 'significant obstacle to an effective response has been the inadequate engagement with affected communities and families. this is not simply about getting the right messages across; we must learn to listen if we want to be heard' (world health organization, c) . similarly, the un, undp, world bank, eu and the african development bank, in its recovery from the ebola crisis, stated that '[t]he low levels of trust in state institutions that existed before the epidemic hampered the response. trust in public institutions could be strengthened through inclusive dialogue, efforts to enhance accountability, and equitable and harmonized service delivery ' (p. ) . the acknowledgement of the importance of community engagement and fostering trust in outbreak management (theme ) should be celebrated. yet, the ethical imperatives to engage communities, build trust and increase accountability have long been recognized as important moral obligations for pandemic planning, and have even been incorporated into pandemic plans as guiding ethical values (kass, ; thompson et al., ; world health organization, a; us centers for disease control and prevention, ; baum et al., ; institute of medicine, ; nigeria integrated national avian ad pandemic influenza response plan, ; thomas et al., ) . for instance, the world health organization's ( a) ethical considerations in developing a public health response to pandemic influenza specifically states that '[p]ublic engagement and involvement of relevant stakeholders should be part of all aspects of planning' (p. ), and goes on to address its application in the context of communication: 'in order for public engagement in preparedness planning to be meaningful, effective modes of communicating with and educating the public about the issues involved are essential ' (p. ) . this relationship between public trust, risk communications and community engagement has also been recognized for some time. following the sars outbreak in toronto, researchers from the university of toronto argued that '[t]rust is an essential component of the relationships among clinicians and patients, staff and their organizations, the public and health care providers or organizations, and among organizations within a health system. decision makers will be confronted with the challenge of maintaining stakeholder trust while simultaneously implementing various control measures during an evolving health crisis' (university of toronto joint centre for bioethics, , p. ). indeed, one of the major obstacles experienced during the sars crisis, which was acknowledged in two major canadian public health reports following the outbreak, was inadequate risk communication (theme ). the sars commission, authored by the honourable mr. justice archie campbell following the outbreak, asserted that '[b]ad communication is a steel thread throughout the story of sars. poor communication exacerbated a confusing and terrible time' (campbell, (campbell, : . in a similar vein, the final report of the who conference on sars concluded that 'information should be communicated in a transparent, accurate, and timely manner. sars has demonstrated the need for better risk communication as a component of outbreak control' (world health organization, b) . trust and transparency are even articulated as guiding principles in the world health organization's outbreak communications planning guide (world health organization, ). yet, years later, the same lessons emerge anew in the context of ebola, as if they have been wiped from our collective memory. failing to heed past lessons of building and fostering trust and neglecting to engage affected communities in outbreak preparedness and response is a moral failing, but this moral failing runs deeper. what many of these lessons fail to acknowledge is that, while community engagement and involvement in planning, decisionmaking and communications are critical to building and preserving trust, trust also has an historical and systemic component (hardin, ) . trust relations are shaped by experiences that extend beyond interactions in the immediate context of a public health emergency. decades of social and personal risk, vulnerability and powerlessness, which are likely to foster distrust, may precede and remain throughout public health crises if not rectified at a systemic level (baier, ) . improving community engagement and community involvement in outbreak preparedness and response will therefore only scratch the surface of building robust relationships of trust. rather, the creation of trustworthy systems should be our goal, where entrusted global health authorities embody a set of ethical values-e.g., solidarity, global justice-that proportionately reflect the trust placed in them. this is not to suggest that the failures identified above must therefore reflect a singular breach of trust by global health authorities, like the who, or that responsibility for these failures lies solely with such an organization. indeed, if no single global health actor possesses the leadership and authority to coordinate and command an effective global outbreak response (as many of the 'lessons learned' documents indicate), it seems there is no single actor to blame. that is, it is not that our trustworthy global health regime has breached our trust, but rather that such a regime does not yet exist. moreover, given that many of these failings can reasonably be seen as stemming from broader social, political and structural global injustices, questions about where responsibility lies with respect to the failures in this evd outbreak become much more complex. these failures ought to be understood as collective failures, where accountabilities lie, to an extent, with us all. as david nabarro, un special envoy on ebola, stated eloquently, '[i]t's not somebody else's problem; it's our collective problem' (beattie, ) . true solidarity entails an acknowledgment of our collective accountabilities. despite ample ethics lessons and guidance documents emphasizing the importance of global solidarity in outbreak prevention and management, community engagement and fostering trust, developing and establishing global governance that is transparent, accountable and inclusive and correcting global inequities in health investment patterns, shortcomings in these areas were present in the evd outbreak. what is troubling is that these shortcomings have been identified as 'lessons learned' from the evd outbreak but their ethical dimensions have largely been neglected. this is perhaps the most conspicuous lesson: our inaction on previous 'lessons learned'. a crucial lesson to learn is why the cumulative ethics knowledge and careful reflection on values and guidance generated following previous outbreaks continues to not adequately inform our efforts in global outbreak management. what is the purpose of ethics guidance documents? is this simply a failure of translating ethics knowledge to policy and practice? if so, what are the obstacles to successful translation of this knowledge? this exercise has highlighted the importance of integrating values and ethics into policy and practice (presidential commission for the study of bioethics ). clearly, there were significant moral failures in the evd outbreak, with some requiring more analytic skill to identify their normative dimension than others. what we have attempted to illustrate in this article is that the examination and integration of values and ethics continues to be neglected among lessons learned, despite the inherently ethical nature of the lessons and the body of literature previously (and concurrently) identifying many of these ethical lessons. there is still much work to be done in order to imbue the approach to global public health emergencies with morally justifiable values and ethical directives. this can only occur, though, if we first acknowledge that our failings in the ebola response were moral failings as a global health community, and that improvements in future outbreaks are predicated on a sea change in the values that undergird our attitude to global public health emergency preparedness and response. perhaps even prior to this we must acknowledge that global health itself is a moral enterprise (benatar, ) . given the increasingly abundant literature pertaining to ethics in pandemic and disaster planning and response, global health ethics and humanitarian health ethics, which includes explicit guidance for pandemic preparedness and response, we must redouble efforts to translate this research into policy and practice. if we are to learn the most important lessons stemming from our experiences with the evd outbreak, a moral reorientation must occur; for if there is no recognition and interrogation of the shortcomings in the values that have thus far informed and guided the current paradigm of global public health emergency preparedness and response, and, indeed, global health more generally-a recognition that the fundamental manner in which we approach such situations is morally deficient-then it is questionable whether future actions will differ substantially. we cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings 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functioning of the international health regulations ( ) in relation to pandemic (h n ) ebola virus disease epidemic in west africa: update and lessons learnt report of the ebola interim assessment panel who statement on the ninth meeting of the ihr emergency committee regarding mers-cov world health organization leadership statement on ebola response and who reforms report of the ebola interim assessment panel an assessment of interactions between global health initiatives and country health systems. the lancet key: cord- - ayjudl authors: liu, shuai; yang, lulu; zhang, chenxi; xiang, yu-tao; liu, zhongchun; hu, shaohua; zhang, bin title: online mental health services in china during the covid- outbreak date: - - journal: lancet psychiatry doi: . /s - ( ) - sha: doc_id: cord_uid: ayjudl nan by mental health professionals in medical institutions, universities, and academic societies throughout all provinces, municipalities, and autonomous regions in mainland china, which provide free -h services on all days of the week. online psychological self-help intervention systems, including online cognitive behavioural therapy for depression, anxiety, and insomnia (eg, on wechat), have also been developed. in addition, several artificial intelligence (ai) programmes have been put in use as interventions for psychological crises during the epidemic. for example, individuals at risk of suicide can be recognised by the ai programme tree holes rescue, by monitoring and analysing messages posted on weibo, and alerting designated volunteers to act accordingly. in general, online mental health services being used for the covid- epidemic are facilitating the development of chinese public emergency interventions, and eventually could improve the quality and effectiveness of emergency interventions. we declare no competing interests. during the severe acute respiratory syndrome epidemic in , internet services and smartphones were not widely available. therefore, few online mental health services were provided for those in need. the popularisation of internet services and smartphones, and the emergence of fifth generation ( g) mobile networks, have enabled mental health professionals and health authorities to provide online mental health services during the covid- outbreak. fast transmission of the virus between people hinders traditional face-to-face psychological interventions. by contrast, provision of online mental health services is safe. to date, several types of online mental health services have been implemented widely for those in need during the outbreak in china. firstly, as of feb , , online mental health surveys associated with the covid- outbreak could be searched for via the wechat-based survey programme questionnaire star, which target different populations, including medical staff ( of the surveys), patients with covid- (one survey), students ( surveys), the general population (nine surveys), and mixed populations ( surveys); in hubei province (five surveys), other provinces ( surveys), all provinces, municipalities, and autonomous regions ( surveys), and unspecified areas of china ( surveys). one such multicentre survey involving medical staff, with our centre at nanfang hospital, southern medical university (guangzhou, china) as one of the study sites, found the prevalence of depression (defined as a total score of ≥ in the patient health questionnaire- ) to be · %, of anxiety (defined as a total score of ≥ in the generalized anxiety disorder- ) to be · %, of insomnia to be · % (defined as a total score of ≥ in the insomnia severity index), and of stressrelated symptoms (defined as a total score of ≥ in the impact of events scale-revised) to be · %. these findings are important in enabling health authorities to allocate health resources and develop appropriate treatments for medical staff who have mental health problems. secondly, online mental health education with communication programmes, such as wechat, weibo, and tiktok, has been widely used during the outbreak for medical staff and the public. in addition, several books on covid- prevention, control, and mental health education have been swiftly published and free electronic copies have been provided for the public. as of february , books associated with covid- have been published, ( · %) of which are on mental health, including the "guidelines for public psychological self-help and counselling of -ncov pneumonia", published by the chinese association for mental health. finally, online psychological counselling services (eg, wechat-based resources) have been widely established the mental health of medical workers in wuhan, china dealing with the novel coronavirus national health commission of china. guidelines for psychological assistance hotlines during -ncov pneumonia epidemic improving older adults' knowledge and practice of preventive measures through a telephone health education during the sars epidemic in hong kong: a pilot study the chinese suicides prevented by ai from afar key: cord- -hnakpl a authors: ruckert, arne; fafard, patrick; hindmarch, suzanne; morris, andrew; packer, corinne; patrick, david; weese, scott; wilson, kumanan; wong, alex; labonté, ronald title: governing antimicrobial resistance: a narrative review of global governance mechanisms date: - - journal: j public health policy doi: . /s - - - sha: doc_id: cord_uid: hnakpl a antimicrobial resistance (amr), a central health challenge of the twenty first century, poses substantial population health risks, with deaths currently estimated to be around , per year globally. the international community has signaled its commitment to exploring and implementing effective policy responses to amr, with a global action plan on amr approved by the world health assembly in . major governance challenges could thwart collective efforts to address amr, along with limited knowledge about how to design effective global governance mechanisms. to identify common ground for more coordinated global actions we conducted a narrative review to map dominant ideas and academic debates about amr governance. we found two categories of global governance mechanisms: binding and non-binding and discuss advantages and drawbacks of each. we suggest that a combination of non-binding and binding governance mechanisms supported by leading antimicrobial use countries and important amr stakeholders, and informed by one health principles, may be best suited to tackle amr. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. antimicrobial resistance (amr) has been widely recognized as one of the central health challenges of the twenty first century [ ] [ ] [ ] . since discovery of antibiotics, they have been a cornerstone of modern medicine [ , ] . amr predates human use of antibiotics and is naturally occurring as the outcome of the evolutionary adaptation process of microbes. but it has become increasingly clear that use of antibiotics, both in human and veterinarian practice and agriculture and animal husbandry, contributes to antimicrobial resistance [ ] . amr poses significant population health risks, with annual deaths estimated to be around , globally [ ] . the international community recently identified it as a major threat to achievement of the sustainable development goals, sdgs [ ] . amr has potential to disrupt the global economy as severely as the global financial crisis of / , with an eventual cost in the trillions of dollars if unaddressed [ ] . the recent covid- outbreak and widespread use of antibiotics with it have raised concerns about the potential of the global pandemic to speed up antimicrobial resistance [ ] . the international community signaled its commitment to exploring effective policy responses, with a global action plan on amr approved by the world health assembly in [ ] . major governance challenges could thwart collective efforts to address amr. we reflect through a narrative review of binding and non-binding governance mechanisms discussed in the academic literature on amr. by mapping these debates, we aim to inform decision-making about the global governance of amr-particularly by identifying potential points of agreement as starting points for strengthening a global amr response. in a growing body of literature about amr governance, many authors begin from a normative preference for a specific governance mechanism, then build a case for that preferred mechanism [ ] . we take a 'step back' to map the preferences and debates, then seek the global governance options that appear most feasible. identifying options for improved global governance of amr is vitally important; despite declaring firm commitment, many countries have not implemented national action plans or taken even sporadic actions to better align the domestic policies with global recommendations [ ] . various sectors involved in amr governance have conflicting interests (such as human and animal health, agriculture, the pharmaceutical industry, and the environment) which could impede collaboration and challenge implementation of solutions-such as enhanced amr surveillance across sectors or addressing excessive use of antimicrobials in agriculture and horticulture [ ] . addressing amr will require global collaboration because no single country can prevent or mitigate amr through its own actions [ ] . as a global common good, safeguarding antimicrobial effectiveness and mitigating the threat of amr in a collaborative fashion are necessarily a responsibility of all countries and multilateral organizations. the global action plan produced by the world health organization, who [ ] , and similar action plans by the food and agricultural organization, fao [ ] and the world organization for animal health, oie [ ] , identify five areas of essential global collective action to address amr: • effective antimicrobial surveillance; • better infection prevention and control (ipc) measures; • global awareness campaigns; • promoting responsible use through stewardship; • innovation for successful containment of amr emergence and spread, including through development of novel antimicrobial drugs. thus, we address the question: which global governance modalities and mechanisms are most likely to produce an effective amr response? we conducted a narrative review to identify global governance mechanisms to address amr currently explored in the academic literature [ ] . because the global amr response is at a relatively early stage and lacks consensus about how best to proceed, this approach allowed us to map out the dominant topics and debates as a first step toward identifying common ground for a basis of more coordinated global action. we used two electronic databases (scopus and pubmed) to identify relevant articles (n = ) and a boolean search strategy (see supplementary materials file). by screening abstracts we identified relevant articles and added more recommended by reviewers during the revision process (for a total of n = ). after removing duplicates, we retained articles using the following inclusion criteria: ( ) identifies governance mechanisms to address amr; ( ) discusses policy framings of amr; ( ) provides policy solutions to effective amr governance; ( ) identifies barriers to, or facilitators of, effective amr governance; and ( ) has been published since . we imported articles into nvivo and conducted a constant comparative analysis based on a deductively developed coding structure, enriched inductively as new ideas and concepts emerged (see supplemental materials file). a limitation is that we included only english language articles. amr governance mechanisms fit in two categories: binding or non-binding. global governance attempts to achieve a purposeful order from institutions, processes, norms, formal agreements, and informal mechanisms that regulate action for a common good, with the question of enforcement of global rules are central to most academic discussions of global governance [ ] . binding governance mechanisms include treaties, covenants, protocols, and accords-the 'gold standard' in global health governance [ ] -because they hold signatories legally responsible and accountable. no such agreement on amr presently exists. the literature considers two approaches-treaties and regulations, each with advantages and disadvantages. some global governance scholars propose developing an international treaty to rectify the current fragmented approach and lack of leadership [ ] [ ] [ ] [ ] [ ] . one notes: "a treaty on managing antimicrobials and containing amr emergence and spread could help coordinate efforts in this area, especially when combined with strong implementation mechanisms and regulatory functions" [ ] . a treaty to promote international compliance would also help to minimize market and competitive disadvantages in particular industries. without such a treaty, a nation's livestock producers who refrained from using antimicrobial growth promoters could be disadvantaged by producers in other countries who did not [ ] . a treaty could promote a global system to facilitate coordination and the legalization of gathering and sharing of surveillance data, and improve transparency and accountability [ ] . a global treaty, if established per article of the who constitution, could also promote wide-scale reductions of infection rates by improving implementation of infection prevention and control (ipc) through development and enforcement of guidelines on sanitation, mapping of microbial spread patterns, and setting standards for infection prevention and control practices [ ] . it could promote stewardship programs, product labelling requirements, better medical waste management policies, and improved sanitation measures by states, for example, by setting desirable benchmarks for antimicrobial use [ ] . a treaty could also impose a global marketing ban on antimicrobials as one element of a larger antimicrobial conservation strategy [ ] . the review revealed considerable challenges and several arguments against pursuing it. reconciling diverse stakeholder interests is one hurdle. states are unlikely to support an international agreement unless it would benefit domestic stakeholders, especially if the corporate sector lobbies against new regulations; all actors must find that benefits outweigh costs and potential harm [ ] . a treaty would likely include an obligation to report regularly on compliance, and few countries have infrastructure or reporting mechanisms for meaningful reporting (observed in partial reporting under the global antimicrobial resistance surveillance system [ ] ). in addition to treaties, regulations can also be legally binding under international law. regulations on antimicrobial use could have binding targets for agricultural use of antibiotics [ , ] . thakur and panda [ ] recommend banning use of all medically important antibiotics in food for animals through global harmonization. the goal is to preserve their effectiveness for necessary medical use. this approach might require global harmonization of categorization and terminology, because what constitutes 'medically important', 'highly important', 'critically important', or 'highest priority critically important antimicrobials' varies across countries. the variations may create confusion-a barrier to effective regulation. regulations could also ban over-the-counter sale of antibiotics and online sale of antimicrobials without prescription globally [ ] . regulation can also encompass quality standards. bloom et al. argue that governments should coordinate their actions globally, set quality standards for drugs and treatment guidelines, and negotiate the contents of advertising material to limit counterfeit and substandard drugs and influence the packaging and marketing of pharmaceutical drugs [ ] . they recommend that this process involve the pharmaceutical sector and leaders of the medical profession to encourage adherence to regulations and quality standards. wernli et al. suggest that emergence and spread of antimicrobial-resistant bacteria, especially those involving new pan-resistant strains for which there are no suitable treatments, may constitute a public health emergency of international concern (pheic). under these circumstances, countries should be required to notify the world health organization under the international health regulations, ihrs [ ] . the ihrs provide a legal framework for international efforts to contain spread of acute health risks, including a surveillance and a global alert system, definitions of core public health capacities for surveillance and response in all countries, and who guidance through standing recommendations. applying the ihrs to amr could "serve as a 'wake-up call' and strengthen global amr surveillance and response, which could in turn contribute to containing the spread of amr" [ ] . another article highlights that, given the prevalence of drug resistant bacteria in traded food commodities, trade agreements should increasingly consider amr, especially in discussions and adjudication of disputes over intellectual property protection [ ] . here the codex alimentarius commission and the world organization for animal health (oie) play important roles because world trade organization members and countries party to other bilateral or regional trade agreements must base regulations on international standards. by establishing stronger regulations these bodies could help tackle amr and contribute to achieving the sustainable development goals [ ] . some raise concerns that existing trade agreements might hamper antimicrobial stewardship initiatives, for example by limiting policy space to restrict food imports from countries that overuse antibiotics [ ] . the european commission raised this issue recently in connection with its ban on antimicrobials to boost growth and yield. some scholars ask whether this new european union (eu) legislation could be challenged at the wto by a country importing food into the eu. the literature discusses non-binding governance mechanisms including political declarations, resolutions, and operational guidelines; public-private partnerships (ppp) based governance mechanisms; and voluntary (consumer and industry driven) governance initiatives. political declarations (resolutions or operational guidelines) cannot compel action, but can foster consensus and cooperation through gradual diffusion of norms [ ] . one article notes: "political declarations offer a nimbler, more adaptive option to the rigidity of legally binding global governance mechanisms such as treaties, and […] allow for more dynamic discourse and better responsiveness to changing global priorities" for amr [ ] . another highlights that non-binding and participatory governance mechanisms could incorporate incentives to private industry to participate in antimicrobial stewardship and surveillance initiatives [ ] . another approach involves a voluntary global antimicrobial conservation fund to provide a transnational resource transfer to boost capacities and program development in the lowest income countries: such a fund would not diminish the responsibility of national governments in the development of their national amr plans nor for delivering meaningful outputs. rather, it would confer support for accelerated action to conserve a rapidly dwindling resource and could be linked to a formal resource conservation agreement [ ] . a pooled fund with contributions tied to gross national income could ensure that assistance supports implementation of the amr global action plan [ ] . not all commentators agree; some warn that normatively based international agreements on amr would lack effective mechanisms for transparency, oversight, and complaint, providing little international pressure or incentives for countries to comply with the unenforceable terms [ ] . the literature also offers financial models to spur the development of new antibiotics, particularly discovery of new drug classes. the use of ppps has a long history in drug innovation, for example with neglected tropical diseases [ ] . given a recent slow-down in commercial development of antimicrobial drugs, analysts have identified ppps as a potential solution to some challenges of developing new antimicrobials. these include high initial development costs; the low price point of most antimicrobials; and the need to limit the use of new drugs once they become available to ensure efficacy over time. one article highlights that, given the economics of the development of new antibiotics, profits from 'drugs of last resort' might not justify investment in this area by private pharmaceutical companies alone. solutions therefore need to include government action in industrialized countries to overcome this 'market failure' by both reducing regulatory barriers to entry and improving the economic incentives for re-engagement by private enterprises [ ] . global governance mechanisms to foster drug innovation should explore and encourage ppps, particularly for treatment of infections in economically disadvantaged parts of the world [ ] . following this logic, government, non-governmental and intergovernmental agencies have called for the development of ppps and innovative funding mechanisms for amr. in its global action plan, the who calls for new partnership models "for providing incentives for innovation and promoting cooperation among policy-makers, academia and the pharmaceutical industry to ensure that new technologies are available globally to prevent, diagnose and treat resistant infections" [ ] . the innovative medicines initiative joint undertaking programme in europe is a prominent example for drug innovation that has invested more than € million. it seeks matching contributions from the european commission and the european federation of pharmaceutical industries and associations. through the new drugs for bad bugs programme, this initiative invests in promising research to fight against amr "at every level from basic science and drug discovery, through clinical development to new business models and responsible use of antibiotics" [ ] . another global partnership, carb-x, accelerates antibacterial research to tackle the global rising threat of drug-resistant bacteria. it boasts the world's largest early development pipeline of new antibiotics, vaccines, rapid diagnostics, and other products to prevent and treat life-threatening bacterial infections. some articles focus on the potential roles for non-state actors, voluntary industry initiatives, and other forms of self-regulation in amr governance [ ] . canada established a deadline of for voluntary phasing out of category i antibiotics, those most important to human health, for the chicken industry. in may , the chicken farmers of canada announced a plan to eliminate preventative use of category ii antibiotics by the end of and a goal to eliminate preventive use of category iii antibiotics by the end of [ ] . growing popular awareness of the risks of the presence of antimicrobials in the food chain and related changes in consumer choices drive these initiatives. the range of binding and non-binding mechanisms proposed indicates a lack of consensus about how best to proceed. it also affirms the complexity of amr as a policy problem. what are the strengths and weaknesses of each approach? and, what are shared principles to undergird an effective governance regime to address amr? currently amr global governance relies entirely on non-binding governance mechanisms. the world health assembly resolution / , the associated global action plan on amr [ ] , and the un general assembly's political declaration on amr (resolution / ) [ ] are the strongest of nonbinding global governance mechanisms implemented. their champions hope these will encourage decisive and lasting global action to curb amr. in theory, such mechanisms could facilitate country driven actions and policy ownership-and increase likelihood that countries implement national-level actions. although voluntary in nature, nonbinding mechanisms may use stronger implementation language than legally binding treaties, and integrate civil society organizations and non-state actors into implementation. this provides political and legal support without the legal consequences of binding governance mechanisms if states fail to meet their commitments [ ] . voluntary contributions and a bottom-up approach to amr would allow low-and middle-income countries to balance safeguarding of antimicrobials with other priorities, such as economic development and food security-and could increase political support among these states. despite the benefits that hierarchical governance might offer through an enforceable treaty, a non-binding network approach could increase shared responsibility to reach goals and more sustainable governance of amr [ ] . failure by many countries to voluntarily adhere to the commitments inscribed in the global action plan, however, is a major concern. the / who report on amr implementation shows that countries developed, or implement national amr action plans reflecting objectives of the global action plan; only countries have directly allocated funding to implement action plans, engaged relevant sectors, and designed a monitoring and evaluation process (as recommended by who) [ ] . aguirre finds that despite needed concerted global effort, only % of countries have implemented a national policy to address antibiotic resistance [ ] . it is not surprising that low-income countries might find it difficult to identify resources to develop and implement an intersectoral amr action plan. but middle-and high-income countries are falling behind as well: only european countries had approved an adequate action plan by [ ] . voluntary governance mechanisms related to climate change and the sustainable development goals (sdgs) have also shown limited impact on state behavior; countries are already falling behind with their voluntary 'nationally determined contributions' (ndcs) to mitigate climate change (agreed upon at the cop paris climate summit) [ ] . concerns that voluntary reporting mechanisms might lack transparency and consistency arise; thus assessing progress might prove difficult. previous experiences of reliance on voluntary governance mechanisms without enforcement instruments indicate limits of norm change as a means to catalyze effective and efficient state action. binding governance mechanisms may be needed. the ad hoc inter-agency coordination group (iacg) for the governance of antimicrobial resistance (made up of who, fao, oie, and various individual experts), acknowledged this recently in laying out a vision for achieving a global treaty within years, either an intergovernmental treaty or a multi-stakeholder amr protocol [ ] . the limits of non-binding governance mechanisms may lend support to the literature advocating a legally binding amr treaty to ensure national compliance with governance principles established at the global level. one recent precedent, the framework convention on tobacco control (fctc), may offer lessons about the impact of international treaties on health governance. a recent review argues: the influence of the who fctc in global governance can be at least partially attributed to its status as an international legal obligation. while tobacco control would have likely been a priority in international public health even in the absence of the who fctc, the importance of tobacco control has been relatively greater as a result of the treaty [ ] . amr, however, poses a very different set of public health problems from tobacco control: it is transboundary, multisectoral, and constantly evolving in a way that tobacco control is not. given these differences, to what extent can lessons from the fctc can be applied to amr governance? also, binding agreements face their own challenges. for example, only industrialized countries committed to legally binding reductions in emissions in the kyoto protocol, one of the most prominent binding global governance efforts. even the committed countries have mixed compliance results [ ] . a binding global agreement is no guarantee of effective domestic actions, especially without political mobilization [ ] . yet, even when expected benefits from binding legal agreements are marginal, such agreements may be useful in supporting implementation of domestic amr policies-albeit incrementally and indirectly: • they might contribute to norm change, and therefore incentivize governments to participate in amr-related activities [ ] . • they could assist domestic non-governmental amr actors in advocating for policy change. lack of consensus, scholarly or political, about how best to structure amr governance indicates major barriers to achieving a binding agreement soon: • to be politically feasible, states and stakeholders must perceive the benefits of any amr treaty or agreement to outweigh current and projected costs and potential health and economic harms [ ] . at a minimum, this would require concerted education campaigns amongst stakeholders, and incentive schemes for industry to partake in stewardship. even then, a widespread perception that a treaty is unlikely if not supported by the most powerful economic countries, especially the united states, china, and japan, could hinder progress. creation of a 'coalition of the willing' might mitigate resistance and entice others to join global amr efforts [ ] . ideally a coalition would include 'initiator countries' (those leading reduction of antibiotic use) and 'pivotal countries', (those with strong influence due to economic and political power). • particularly low-income countries may perceive treaties that impose domestic obligations as coercive and paternalistic; standard setting in international treaties are largely dictated by high-income countries on the basis of policy guidelines/ actions that these countries already meet. ensuring development of governance rules in international fora or by international organizations in which countries have equal standing (the who versus world bank), and ensuring any international treaty includes binding agreements for resource transfer from north-south (hic-lic) might mitigate this barrier. our review did find virtually unanimous agreement on a key principle to undergird effective global governance: all efforts, legally binding or nonbinding, should approach amr through a one health lens to address human, animal, and environmental health and their complex interactions [ ] . one health entails balancing of competing interests across sectors, while privileging human over animal health: "typically, human health interests should predominate, but animal health and welfare are also important considerations,… economic interests are subordinate to health considerations" and "antimicrobial stewardship programs should seek to ensure that antimicrobials are reserved for the treatment of clinical infections in humans" [ ] . apparent consensus about one health may indicate the emergence of a new norm as a promising foundation for coordination. over time, it could generate the shared political will required to support development of more robust binding mechanisms. our review indicates strong interest in and a good rationale for top-down global governance mechanisms to address amr. a lack of consensus persists, however, about which specific mechanisms are most desirable, politically feasible, and likely to be effective. deep and divergent perspectives remain (often implicit rather than explicitly stated) about the causal relation between legal and normative change: • is norm change a necessary antecedent to generating the political will required to produce legal change in the form of a binding agreement? • or does legal change, by compelling changes in actors' behavior and policies, represent the catalyst for a subsequent change in reinforcing norms? clearly, securing an international treaty and enforceable market regulations might not be sufficient to address amr, especially if the biggest user countries of antimicrobials, and the agricultural industries in them, remain opposed to strong amr regulations. currently, this seems to be the case. a reduction of amr consumption might therefore best be achieved by combining a governance system with an enforceable treaty (initially with those countries willing to volunteer), with the development of various non-binding governance and stewardship initiatives with engagement of important stakeholders to raise awareness and shift deeply entrenched human and animal health practices. thus, we advocate combining pressure from below (by civil society and progressive actors promoting grass-roots solutions to amr) with pressure from above (through international legal obligations) that could generate momentum towards implementation of effective policy solutions to this important global health issue. author contributions all authors contributed to the study design. data collection and coding of data was led by ar and rl. all authors equally contributed to drafting the manuscript and approved the final version of the article. the study received funding from the canadian institute of health research through operating grant no. . the study received logistical support from the one health network on the global governance of infectious disease and antimicrobial resistance (global hn). antimicrobial resistance in g countries and beyond: policy brief. organization for economic development and cooperation drug-resistant infections; a threat to our economic future tackling antimicrobial resistance: ensuring-sustainable r&d. world health organization global governance mechanisms to address antimicrobial resistance antimicrobial resistance: action to combat the rising microbial challenges antibiotics overuse in animal agriculture: a call to action for health care providers tackling drug-resistant infections globally: final report and recommendations. london: united kingdom review on antimicrobial resistance antimicrobial resistance-a threat to the world's sustainable development antimicrobial resistance in the age of covid- monitoring global progress on addressing antimicrobial resistance. geneva: who combating antimicrobial resistance demands nation-wide action and global governance global governance of antimicrobial resistance the fao action plan on antimicrobial resistance world organisation for animal health scoping studies: towards a methodological framework oxford: pergamon towards an international treaty on antimicrobial resistance addressing antibiotic resistance requires robust international accountability mechanisms an international legal framework to address antimicrobial resistance assessing proposals for new global health treaties: an analytic framework effective global action on antibiotic resistance requires careful consideration of convening forums global health law clinic: using international instruments to address antimicrobial resistance. global health law clinic publication series developing an approach to assessing the political feasibility of global collective action and an international agreement on antimicrobial resistance a call for action: the application of the international health regulations to the global threat of antimicrobial resistance rational use of antimicrobials in animal production: a prerequisite to stem the tide of antimicrobial resistance antimicrobial resistance and universal health coverage trade is central to achieving the sustainable development goals: a case study of antimicrobial resistance antimicrobial resistance, trade, food safety and security comparison of governance approaches for the control of antimicrobial resistance: analysis of three european countries a global antimicrobial conservation fund for low-and middle-income countries much can be learned about addressing antibiotic resistance from multilateral environmental agreements virtual drug discovery and development for neglected diseases through public-private partnerships tackling antibiotic resistance reflections on the future of pharmaceutical public-private partnerships: from input to impact the innovative medicines initiative's new drugs for bad bugs programme: european public-private partnerships for the development of new strategies to tackle antibiotic resistance what matters to us: antibiotics. chicken farmers of canada an international model for antibiotics regulation beyond headline mitigation numbers: we need more transparent and comparable ndcs to achieve the paris agreement on climate change future global governance for antimicrobial resistance who fctc and global governance: effects and implications for future global public health instruments the glocalization of antimicrobial stewardship. glob health exploring models for an international legal agreement on the global antimicrobial commons: lessons from climate agreements. health care anal antimicrobial resistance: a one health perspective governing antimicrobial resistance: a narrative review of… pdf?expir es= &id=id&accna me=esid &check sum= c b e a bd b c e f e conflict of interest the authors have no competing interests to declare. the study received ethics approval from the university of ottawa ethics review board.governing antimicrobial resistance: a narrative review of… key: cord- -bainw d authors: haque, mainul; sartelli, massimo; mckimm, judy; abu bakar, muhamad title: health care-associated infections – an overview date: - - journal: infect drug resist doi: . /idr.s sha: doc_id: cord_uid: bainw d health care-associated infections (hcais) are infections that occur while receiving health care, developed in a hospital or other health care facility that first appear hours or more after hospital admission, or within days after having received health care. multiple studies indicate that the common types of adverse events affecting hospitalized patients are adverse drug events, hcais, and surgical complications. the us center for disease control and prevention identifies that nearly . million hospitalized patients annually acquire hcais while being treated for other health issues and that more than , patients (one in ) die due to these. several studies suggest that simple infection-control procedures such as cleaning hands with an alcohol-based hand rub can help prevent hcais and save lives, reduce morbidity, and minimize health care costs. routine educational interventions for health care professionals can help change their hand-washing practices to prevent the spread of infection. in support of this, the who has produced guidelines to promote hand-washing practices among member countries. health care-associated infections (hcais) are those infections that patients acquire while receiving health care. the term hcais initially referred to those infections linked with admission to an acute-care hospital (earlier called nosocomial infections), but the term now includes infections developed in various settings where patients obtain health care (eg, long-term care, family medicine clinics, home care, and ambulatory care). hcais are infections that first appear hours or more after hospitalization or within days after having received health care. multiple studies indicate that the most common types of adverse events affecting hospitalized patients are adverse drug events, hcais, and surgical complications. [ ] [ ] [ ] [ ] [ ] the us center for disease control and prevention identifies that nearly . million hospitalized patients annually acquire hcais while being treated for other health issues and that more than , of these patients (one in ) die due to hcais. the agency for health care research and quality reported that hcais are the most common complications of hospital care and one of the top leading causes of death in the usa. out of every hospitalized patients, seven patients in advanced countries and ten patients in emerging countries acquire an hcai. other studies conducted in high-income countries found that %- % of the hospitalized patients acquire hcais which can affect from % to % of those admitted to intensive care units (icus). , multiple research studies report that in europe hospital-wide prevalence rates of hcais range from . % to . %. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] the who reports however that hcais usually receive public attention only when there are epidemics. hcais also have impact on critically ill patients with around . million episodes of hcais being diagnosed every year in icus alone. , , icu patients are often in a very critically ill, immuno-compromised status which increases their susceptibility to hcais. , brief history there has been long-standing awareness that the practice of medicine can do harm as well as good. for example, hippocrates, the father of modern medicine, stated more than , years ago that "i will use treatments for the benefit of the ill in accordance with my ability and my judgment, but from what is to their harm and injustice i will keep them." it was also recognized (eg, by semmelweis discussing puerperal fever) many years ago that coming into hospitals (in particular) can be dangerous. in this century, the idea that medicine could cause harm, including death is described as "unintended physical injury resulting from or contributed to by medical care, including … [its] absence … that requires additional monitoring, treatment or hospitalization, or … results in death." , offering another perspective, an american natural sciences writer noted that hcais are now killing around , people, many more than hiv/aids, cancer, or road traffic accidents. the hungarian obstetrician professor (dr) ignaz phillip semmelweis is largely considered as the medical doctor who realized that health care providers could communicate disease. his work identified the mode of communication and spread of puerperal sepsis while working at the maternity hospital in vienna. in , he observed higher rates of maternal mortality among patients treated by obstetricians and medical students than among those cared for by midwives. at that time, he also found that a pathologist had died of sepsis after wounding himself with a scalpel while carrying out an autopsy on a patient with puerperal sepsis. the pathologist's illness mirrored that of women with puerperal sepsis, and semmelweis wrote that both a scalpel and a physicians' contaminated hands could transmit organisms to mothers during labor. he introduced chlorinated lime hand washing to the obstetric hospital staff, resulting in large improvements in maternal mortality rates. however, semmelweis' theories were dismissed by most of the medical establishment because of a lack of appropriate statistical analysis of the data. nevertheless, after koch's postulates were published in , the germ theory of disease and semmelweis' theory of transmission of disease from doctor to patient were found to be valid. semmelweis was therefore the first to describe an hcai and provide an intervention to avert its spread through hand hygiene. a survey conducted in us hospitals with , patients reported that % of patients had at least one hcai with the most common microorganism being clostridium difficile. most infections were surgical site infections (ssis), pneumonia, and gastrointestinal infections. a study years earlier by the same group found that % ( ) of patients had suffered from hcais with the top . % acquiring ssis, urinary tract infections (utis), pneumonia, and bloodstream infections. staphylococcus aureus was the most frequently detected microorganism. the group conducted a comparative study between and and found a statistically significant (p< . ) reduction of hcais in ssis, utis, and central line infections, probably due to a national initiative. hcais are also problematic elsewhere in the world. for example, a study in singapore reported . % ( ) patients with hcais, primarily undetermined clinical sepsis, and pneumonia caused mainly by s. aureus and pseudomonas aeruginosa. this study also reported that the acinetobacter species and p. aeruginosa were extremely resistant to carbapenem. a recent european study found that , , new patients were identified as having hcais annually in the european union and european economic area. this study revealed that for every patients hospitalized, at least one acquired an hcai which was preventable. klebsiella pneumoniae and the acinetobacter species were exceedingly resistant to multiple antimicrobials, and the lack of new antimicrobials increases the huge burden in europe. in greece, the hcai prevalence rate was . %. the frequent types of hcais were lower respiratory tract infections (lrtis), bloodstream infections, utis, ssis, and systemic infections. one systematic review and meta-analysis regarding hcais in southeast asian countries (brunei, myanmar, cambodia, east timor, indonesia, laos, malaysia, the philippines, singapore, thailand, and vietnam) found an overall prevalence rate of . % with the most common microorganisms being p. aeruginosa, the klebsiella species, and acinetobacter baumannii. a study conducted in eight university hospitals of iran (ranging from to beds) reported an overall hcai frequency of . %, the most common hcais were bloodstream infections, ssis, utis, and pneumonia. - . ) . being admitted to an icu is not in itself a self-determining hcai risk factor. the or for all hcais of acquiring an infection was . ( % ci . - . ) in patients with hospital stays longer than days. seventy-one percentage ( %) of the studied patients received antimicrobials, but . % had at least one evidence of infection. another study revealed that the average number of microbes ranged from on ( . × ), working surfaces ( . × ), door handles ( . × ), and highest in taps ( . × ). the highest number ( ) of pathogens were isolated from door handles, and the peak variance of pathogens were on hospital floors ( ). among those microbes, those that were disease-producing were . %, . % were nonpathogenic, the most common was s. aureus at . % and . % of the total bacterial isolates comprised bacillus subtilis. a study conducted in ghana reported that gentamicin was the most effective antibiotic ( %) on both gram-positive and gram-negative organisms, but of the antibiotics tested (ampicillin, cefuroxime, cotrimoxazole, cefotaxime, tetracycline, amikacin, gentamicin, chloramphenicol, cefixime, cloxacillin, and erythromycin), six were resistant to either gram-positive or gram-negative organisms. most of the hcais in the us are triggered by the eskape group, comprising the antimicrobial-resistant gram-negative microorganisms (k. pneumoniae, a. baumannii, p. aeruginosa, and enterobacter spp.) and the grampositive species, enterococcus faecium and s. aureus. [ ] [ ] [ ] multiple studies report that gram-negative organisms are responsible for %, %- %, of hcais and that antimicrobial resistance places a significant burden on the global health care system, particularly in low resource countries. , this problem is exacerbated as research and development into new antimicrobials targeting gram-negative organisms has rapidly decreased in recent years. among the newer aminoglycosides, plazomicin has been found to be active against the extended-spectrum betalactamase (esbl) generating strains of enterobacter spp., escherichia coli, and k. pneumoniae and more effective in laboratory experiments against a. baumannii than gentamicin, tobramycin, and amikacin. plazomicin has a better safety profile than other drugs, with no report of damage to the cochlea, auditory nerve, vestibular, and renal system in healthy volunteers, even with high and multiple doses. another study found that, in a comparison between hcais due to methicillin-sensitive s. aureus and methicillin-resistant s. aureus (mrsa), isolates were statistically significantly (p< . ) more resistant to ciprofloxacin, clindamycin, trimethoprim/sulfamethoxazole, erythromycin, gentamicin, and tetracycline. hospital waste, especially contaminated surgical waste, often acts as a reservoir for pathogenic virulent microorganisms, and it suggested that %- % of the waste produced by health care outlets is considered to have high potential to cause hcais, it therefore needs appropriate handling and disposal. , some of these gram-negative microorganisms have a much higher rate ( %- %) of resistance than others with the organisms isolated from device-associated hcais having the highest antimicrobial resistance phenotypes. in the latter study, although similar to the percentage resistance for most phenotypes was that in an earlier research study, an upsurge in the scale of the resistance fractions against e. coli pathogens was observed, especially with fluoroquinolones. acinetobacter, burkholderia spp. and pseudomonas spp. isolates were % were % resistant to cephalosporins respectively. burkholderia spp. was again totally resistant to fluoroquinolones and acinetobacter spp. and pseudomonas spp. were . % and . % resistant, respectively. the same study reported that . % acinetobacter spp. and . % pseudomonas spp. showed a high resistance to carbapenems, the preferred drug regime in icus. carbapenems were found more effective against burkholderia spp. with % resistance. in another study, enterobacteriaceae community were found to be completely resistant to third-generation cephalosporins. over % of the klebsiella spp. community were resistant to ciprofloxacin, gentamicin, piperacillin, tazobactam, and imipenem showing . % resistance. e. coli was equally resistant although carbapenems were effective in almost haque et al % cases. although citrobacter spp.-related hcais are a relatively minor proportion, they also show resistance toward cephalosporins, fluoroquinolones, and aminoglycosides. another study reported that although the acinetobacter spp. were . %- . %, resistant to most antimicrobials, only % of acinetobacter spp. isolated were susceptible. it can be seen therefore that the causative pathogenic microorganisms differ from country to country as does patterns of resistance. alongside infections due to cross-contamination between patients and health workers, patients being susceptible to common infections due to diminished immune responses, and infections at surgery sites (ssis), many hcais are due to implants and prostheses. these include central line-associated bloodstream infections (clabsis), catheter-associated utis, and ventilator-associated pneumonia (vap). , , clabsis clabsis substantially increase morbidity, mortality, and health care costs, and great attention has been paid to addressing these. , as a consequence, in , , fewer clabsis occurred in the icus of us hospitals than in , a % reduction, with about , lives saved and estimated financial savings of us$ million in potential excess health care costs, although the costs of reducing such infections is very high. it is estimated that it costs ~$ . billion between and to save an additional , lives. despite this investment, a considerable number of clabsis still occur, especially in outpatient hemodialysis centers and inpatient wards. another study also reported the link between clabsis and considerable morbidity and mortality, although there is a wide variation in reported infection rates (from % to . %) in emerging economies. a study conducted in taiwan reported the occurrence of clabsis as . per , central-catheter days. the most common causative pathogens were gram-negative ( . %), gram-positive ( . %), and candida spp. microorganisms ( . %). in this study, patients developed clabsis days from the time of insertion of the central line catheter. multivariate analysis showed that a higher pitt bacteremia score (or . ; % cl= . - . ) and the prolonged interval between the onset of clabsis and catheter removal (or . ; % ci= . - . ) were associated with higher death rates. another similar study identified prolonged catheter in situ, pediatric icu stay, and intravenous nutrition were significant prognosticators of peripherally inserted central catheter-related clabsis among hospitalized children. ssis ssis (formerly termed "wound infections") are still one of the most common adverse events that occur in hospitalized patients undergoing surgery or in outpatient surgical measures, regardless of the advances in preventive procedures. ssi is the most common complication in postoperative surgical patients, associated with significant morbidity, high death rates, and financial stress on national budgets and individual patients. [ ] [ ] [ ] ssis are defined as infections arising up to - days after surgery in patients receiving an organ, group of cells, or device and affecting both the incisional site and deeper tissues around the surgery location. , the type of surgery determines the proportion of ssis. between % and % of patients may develop ssis, with the highest risk for orthopedic followed by cardiac and intraabdominal surgery. , , , the length of hospital stay for patients with ssis increases from to days as compared with patients with no post-surgical infections. [ ] [ ] [ ] approximately % of patients with ssis develop severe sepsis and shock and are moved to an icu. ssis cause statistically significant morbidity, mortality, and financial burdens for individuals and for communities. [ ] [ ] [ ] hcais are common following cardiac surgery, with a reported incidence rate of between . % and . %, , often accompanied with multiple organ failure and prolonged hospital stays, leading to increased mortality rates. , the three most common locations for hcais after cardiac surgery are lungs, central venous catheters, and surgical sites. ssis followed by cardiac surgery classically present with localized cellulitis (erythema, warmth, and tenderness), purulent discharge, sternal instability, chest pain, and systemic upset with deep infections. [ ] [ ] [ ] ssis are devastating for orthopedic patients as it is very difficult to rid the bones and joints of the infection. one saudi arabian study reported an incidence of ssis in orthopedic patients of . % ( of , patients) with the most common pathogens being staphylococcus species including mrsa ( . %); acinetobacter species ( . %); pseudomonas species ( . %), and enterococcus species ( . %). surgical wound contamination potentials, patients' clinical conditions, type of surgery, and length of surgery were variables statistically significantly associated with ssis and should be viewed as risk factors. the movement and number of staff and the structural features of the operating theater also affect the incidence of ssis. , one study found that . % cases of ssis following orthopedic surgery were culture positive, and a total of bacterial strains were isolated, among which . % were grampositive isolates and . % were gram-negative bacteria. infection and drug resistance : submit your manuscript | www.dovepress.com health care-associated infections and prevention strategy about . % of all bacterial isolates were resistant to cefuroxime used in the management of orthopedic ssis. this study also found that diabetes mellitus, smoking, operations lasting more than hours, the absence of antibiotic prophylaxis, and a history of previous surgery were positive risk factors associated with a significant upsurge in ssis. ssis comprise at least %- . % of all hcais for abdominal surgery [ ] [ ] [ ] and often lead to extended hospitalization and higher antimicrobial costs. the microorganisms generally involved in such ssis include s. aureus, coagulasenegative staphylococci and enterococcus spp., and e. coli. s. aureus has been known to be a major cause of hcais for over years. when first introduced, nearly all strains were susceptible to penicillin, but since its wide and often irrational use, s. aureus started to become resistant by producing β-lactamase enzyme. by , % hospital variants of s. aureus were resistant. , to help combat resistance, several new penicillins were developed to resist staphylococcal β-lactamase, such as methicillin, oxacillin, cloxacillin, and flucloxacillin. however, within year of methicillin being marketed in , the first mrsa strain of s. aureus was reported in england. the mrsa strain represents % of hcais in the us and europe and causes infections that are very difficult to manage because of their potential resistance to multiple antimicrobials. [ ] [ ] [ ] in one study, the incidence of ssis was after gastrectomy in . %, after colorectal surgery in . %, after hepatectomy in . %, and after pancreaticoduodenectomy in . %. while the incidence of ssis was higher in the absorbable stitching material than the silk group for all surgical procedures, the difference was not statistically significant. a japanese study on abdominal surgery reported an overall ssi rate of . %. the ssi rates in the suture-less, vicryl, and silk groups were . %, . %, and . %, respectively, again with no statistically significant differences between the groups. in colorectal surgery, the ssi rate in the polyglactin (absorbable, synthetic, usually braided suture; vicryl tm ) group was . %, which was statistically significantly lower than that of the silk group ( . %; p= . ). the incidence of deeper ssis in the vicryl group, including deep incisional ssis (issis) and organ/space ssis (osis), was statistically significantly lower than that in the silk group (p= . ). the ssi rates did not differ among the suture types overall in gastric surgery or in appendectomy. a us study of pediatric patients found that while this was only . % of the caseload, colorectal surgery contributed to . % of the ssis. the ssi rates of all types of colorectal surgery were . % (issis: . %; osis: . %) with the uppermost being total abdominal colectomy ( . %) trailed by partial colectomy ( . %) and colostomy closure ( . %). inflammatory bowel diseases caused the topmost health problems in a comparison of all colorectal diagnosed diseases ( . %; issis: %; osis: . %). hirschsprung's disease ( . %; issis: . %; osis: . %) and anorectal malformations ( . %; issis: . %; osis: . %) were the next major group in colorectal diseases. finally, a study utilizing univariate analysis defined statistically significantly variables related to ssis. those were patients aged over years, lower functional status, diabetes mellitus, congestive heart failure, immunocompromising disease, anticancer medications, immunosuppressive agents, impaired immune system, open cholecystectomy, laparotomy, an american society of anesthesiologists score above , drain insertion, and dirty wound. using multivariate regression analysis, this study also found that immunosuppressive agents (or = . internationally, utis are the most common hcais and one of the top ranking microbial infections, representing around % of hcais, with significant consequences for morbidity and mortality and substantial financial implications. , , although cautis are typically benign, some patients have potentially pathogenic virulent bacteria but are asymptomatic, and these patients were associated with a three-times higher mortality than in non-bacteriuric patients. , multivariate analysis indicates the risk factors for cautis including prolonging the duration of the catheter, female sex, older age, diabetes mellitus, the absence of systemic antibiotics, catheter insertion outside the operating room, and a breach in the closed system of catheter drainage. , the rate of cau-tis has been estimated to be about % per day, regardless of the duration of the indwelling catheter, with e. coli being the main infecting pathogenic microorganism, although a wide spectrum of other microorganisms were identified, including eukaryotic fungus. , the repetitive inappropriate administration of antimicrobials often leads to greater bacterial resistance. cautis habitually lead to biofilm formation on both the extraluminal and intraluminal portal catheter surface, largely from extraluminal microorganisms. [ ] [ ] [ ] the biofilm defends microbes from both antimicrobials and host defense mechanisms. haque et al inserted and cleaned, in patients with long-term indwelling catheters, fever from cautis is common with a frequency fluctuating from one per to one per , catheter days. patients in institutional care with long-term indwelling catheters have a greater risk for the presence of pathogenic microorganisms and other urinary tract diseases than those without catheters. one meta-analysis found that cautis were linked with statistically significantly higher death rates (or = . ; % ci = . - . ; p< . ; i = %; eight studies; , patients) and days in the icu (weighted mean difference of + days; % ci = - ; p< . ; i = %; seven studies; , patients) and hospital (mean difference + days; % ci = - ; p< . ; i = %; five studies; , patients). an australian health care-associated urinary tract infection (hcauti) non-concurrent cohort study carried out for consecutive years found that patients had an extra days ( % ci = . - . days) of hospitalization. this study further reported that the infection rate was statistically significantly minimized utilizing a cox regression model (hr = . ; % ci = . - . ) when patients were released from the hospital. hcautis very rarely cause death (hr = . ; %ci = . - . ), especially in large hospitals when compared to other health care institutes, even when compared with age and sex (hr = . ; % ci = . - . ), although elderly patients more often died (hr = . ; % ci = . - . ). vap the death risk for patients in the icu is not only because of their original illness but often because of hcais. , , pneumonia is the second commonest hcai in icus, affecting more than one-quarter of patients. , around % of hcais are associated with motorized automatic ventilation and vap. between % and % of patients with assisted ventilation develop this kind of pneumonia, and vap has been identified internationally as a potential major cause of death. the average critical time to develop vap following endotracheal intubation and mechanical ventilation was - days. patients usually develop a fever, altered bronchial sounds, white blood cell counts reduced, changes in sputum, and causative organisms are often identified. [ ] [ ] [ ] [ ] [ ] [ ] a us study found a range of vap of between . and . per , ventilator days although an international group reported a much higher occurrence of vap of . / , ventilator days. in asian countries, a different picture of . - infections/ , ventilator days emerges, with a very high incidence rate in india of . per , ventilator days. the initial days of mechanical ventilation is the most critical time for the development of vap, with a mean duration of . days between intubation and the development of vap. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] another recent indian study reported that non-fermentative gram-negative bacilli were the predominant organisms, followed by pseudomonas and klebsiella genus. in this study, s. aureus reduced in prevalence from % to . % between and , but between and vancomycin-resistant enterococci increased from . % to . %, while methicillin resistance among s. aureus exceeded % in . in addition, an upwavard trend in resistance by pseudomonas genus was observed for piperacillin-tazobactam, amikacin, and imipenem. the incidence of non-fermenters' resistance continued to be very high except for amikacin and imipenem ( . %) and polymyxin-b ( . %). a study at chonnam national university hospital in south korea of the transtracheal aspirates or bronchoalveolar lavage of patients suffering from vap found that s. aureus ( %) was the most frequently detected causative microorganism followed by a. baumannii ( %), p. aeruginosa ( %), stenotrophomonas maltophilia ( %), k. pneumoniae ( %), and serratia marcescens ( %). in addition, s. aureus was found as mrsa and % of acinetobacter baumannii were imipenem-resistant. no statistically significant variance was observed in the imipenem-resistant a. baumannii between the earlier and late vap-related study groups ( % [ / ] vs % [ / ] , p= . ). in this study, % of k. pneumoniae was esbl-positive. vap was frequently linked with substantially increased morbidity, including prolonged icu and hospitalization, and higher ventilator days and health care costs. in the uk and the republic of ireland, a european study of hcais connected with respiratory infection found a prevalence rate of . %. among these hcais, . % were pneumonia, and % were lower respiratory tract infections other than pneumonia (lrtiop). around % of patients in both the groups were having artificial ventilation, which was much higher when compared to the rest of the patients with hcais. mrsa was the principal invading microorganism for both pneumonia and lrtiop. although the patients with lrtiop suffered more from c. difficileinduced diarrhea than pneumonia, this was not statistically significant. a recent chinese study reported that . % ( ) of inpatients acquired a lrti which prolonged their hospital stay and increased the costs per individual case by us$ , . . another study revealed that . % of patients developed hcais, of which respiratory tract infections were the highest at . %. the most frequently identified respiratory pathogen was gram-negative acinetobacter species ( . %), and among these % were mdr. submit your manuscript | www.dovepress.com health care-associated infections and prevention strategy a significant number of patients develop pneumonia after surgery which includes both hospital-acquired pneumonia (pneumonia developing - hours after admission) and (as discussed above) vap (pneumonia developing - hours after endotracheal intubation). postoperative pneumonia has been described as one of the leading consequences of all types of surgery with a high incidence of morbidity and mortality. it increases hospital stays on an average of - days and increases health care costs from us$ , to us$ , . , , hcais hcais are a major safety concern for both health care providers and patients. they continue to escalate at an alarming rate, especially in emerging economies, with infection rates - times higher than in high-income countries. , , hcais increase morbidity, mortality, length of hospital stays, and costs; - therefore, more research and changes in practice are needed to ensure hospital safety and prevent hcais. , [ ] [ ] [ ] the annual costs for hcais alone in the usa are between us$ and us$ billion, but with even this amount of spending, , lives are still lost per year: hcais are among the top five killers in the usa. , [ ] [ ] [ ] [ ] the who advocates that effective hand hygiene is the single most important practice to prevent and control hcais, which form colonies with mdr microbes. , , , several studies report that a simple and straightforward process, taking only a few seconds to clean hands with an alcohol-based hand rub helps prevent hcais and save lives, reduce morbidity, and minimize health care costs. , however, factors such as the availability of alcohol-based hand rubs and up-to-date knowledge of the importance of hand washing hinder good practice in hand hygiene. for example, an australian observational study of community nurses highlighted poor practices of hand hygiene in comparison with a standard protocol. the who promotes and advocates that all health care workers (hcws) must wash their hands before touching a patient, before clean/aseptic procedures, after body fluid exposure/risk, after touching a patient, and after touching patient surroundings. the center for disease control and prevention has developed a comprehensive plan and guidelines for the prevention of hcais which covers basic infection prevention and control (ipc); antibiotic resistance; device-and procedure-associated infections; disease/ organism-specific infections; and guidance for health workers working in specific settings. this guidance, like that of the who and the uk royal college of nursing (rcn) also emphasizes the importance of hand washing. [ ] [ ] [ ] the rcn also promotes and advocates that all health care profes-sionals must receive compulsory "infection control training as part of their induction and on an ongoing annual basis. it is particularly important that knowledge and skills are continually updated." multiple research studies indicate that policy changes and the adoption of novel multifactorial, multimodal, multidisciplinary strategies offer the greatest possibility of success in terms of hand hygiene improvement and the reduction of hcais. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] instigating best practice in health care stems "from a response to factors that are outside a purely scientific understanding of infection and not simply understood as a deficit in knowledge." , good practice for infection prevention among hcws can be ensured through compliance to ipc guidelines. specific individuals acting as "change champions" can act as arbitrators or negotiators, contributing to changing behaviors and implementing best practice to ensure patient safety. [ ] [ ] [ ] [ ] this calls for educational interventions that reflect the philosophies, principles, and community understanding of dirt and infection. an educational intervention involving , health professionals in three public hospitals in the usa successfully improved hand hygiene immensely with the use of alcohol hand rub. nurses, physicians, and allied hcws improved from % to %, . % to %, and % to %, respectively. other studies also highlight how behavior change around hand washing can result from educational interventions. , , health professionals must protect themselves with barriers for example, gloves, gowns, face masks, protective eyewear, and face shields, to decrease the work-related transmission of microorganisms. regular use of personal protective equipment (ppe) devices protects both the professional and the patient from potentially infectious body fluids. nevertheless, the use of ppe does not confirm % protection, for example, needlestick injury can breach ppe, and, in many occasions, issues might go unrecognized which might cause a dangerous health hazard including hepatitis b or hiv. respiratory microorganisms, for example, influenza virus, bordetella pertussis, haemophilus influenzae, neisseria meningitidis, and mycoplasma pneumoniae, severe acute respiratory syndrome-associated coronavirus, group a streptococcus, adenovirus and rhinovirus, and tubercular bacilli are easily dispersed through droplets (particles ≤ µm in size) in closed health care settings and often cause endemics and epidemics. [ ] [ ] [ ] [ ] [ ] meticulous cleaning of hospital surfaces is therefore vital to maintain standards and reduce the risk of hcais. several studies conclude that ultraviolet devices and hydrogen peroxide vapor technologies successfully eradicate potentially dangerous hospital microorganisms adhering to the surfaces in ward or patient rooms. [ ] [ ] [ ] [ ] furthermore, hydrogen peroxide vapor efficiently sterilizes and sanitizes all clinical areas where potentially dangerous microbial mdr microorganisms and spores were suspected to be present. in the early to mid- th centuries in both europe and usa, thousands of young women died from puerperal sepsis and fever, the diseases rampant in the charity maternity clinics of the time and, due to the efforts of (among others) dr ignaz phillip semmelweis and dr oliver wendell holmes, the fight against puerperal fever was won and it was confirmed that hcais were transmitted via the hands of hcws. 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hand hygiene: back to the basics of infection control a short history of midwifery. philadelphia; london: w. b. saunders company the authors are grateful to dr zakirul islam, associate professor and head of the department, pharmacology and therapeutics, eastern medical college, comilla, bangladesh for his cooperation in converting the video abstract from a powerpoint file to video format. the authors report no conflicts of interest in this work. infection and drug resistance is an international, peer-reviewed openaccess journal that focuses on the optimal treatment of infection (bacterial, fungal and viral) and the development and institution of preventive strategies to minimize the development and spread of resistance. the journal is specifically concerned with the epidemiology of antibiotic resistance and the mechanisms of resistance development and diffusion in both hospitals and the community. the manuscript management system is completely online and includes a very quick and fair peerreview system, which is all easy to use. visit http://www.dovepress.com/ testimonials.php to read real quotes from published authors. health care-associated infections and prevention strategy key: cord- -xe lljz authors: overgaauw, paul a.m.; vinke, claudia m.; van hagen, marjan a.e.; lipman, len j.a. title: a one health perspective on the human–companion animal relationship with emphasis on zoonotic aspects date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: xe lljz over time the human–animal bond has been changed. for instance, the role of pets has changed from work animals (protecting houses, catching mice) to animals with a social function, giving companionship. pets can be important for the physical and mental health of their owners but may also transmit zoonotic infections. the one health initiative is a worldwide strategy for expanding collaborations in all aspects of health care for humans, animals, and the environment. however, in one health communications the role of particularly dogs and cats is often underestimated. objective: evaluation of positive and negative one health issues of the human–companion animal relationship with a focus on zoonotic aspects of cats and dogs in industrialized countries. method: literature review. results: pets undoubtedly have a positive effect on human health, while owners are increasing aware of pet’s health and welfare. the changing attitude of humans with regard to pets and their environment can also lead to negative effects such as changes in feeding practices, extreme breeding, and behavioral problems, and anthropozoonoses. for the human, there may be a higher risk of the transmission of zoonotic infections due to trends such as sleeping with pets, allowing pets to lick the face or wounds, bite accidents, keeping exotic animals, the importation of rescue dogs, and soil contact. conclusions: one health issues need frequently re-evaluated as the close human–animal relationship with pet animals can totally differ compared to decennia ago. because of the changed human–companion animal bond, recommendations regarding responsible pet-ownership, including normal hygienic practices, responsible breeding, feeding, housing, and mental and physical challenges conforming the biology of the animal are required. education can be performed by vets and physicians as part of the one health concept. the one health initiative or concept is a worldwide strategy that recognizes that public health is connected with animal health and the environment. it concerns multidisciplinary collaboration between physicians, veterinarians, environmental scientists, public health professionals, wildlife experts, and many others [ , ] . with a multisectoral and transdisciplinary approach, public health threats can be better monitored and controlled. the resulting synergism enhances the knowledge of how diseases, known as zoonotic diseases, can be shared between animals and people with the goal of this article is based on an existing post-graduate course for veterinarians, vet technicians, family doctors, midwifes, and specialists such as pediatricians which explores healthy human-animal relationships. the existing evidence-based knowledge contained in this course has been actualized by performing a literature search to add new relevant publications. a literature search was conducted through march , using the national library of medicine's pubmed for the terms "one health" and "companion animals"; "pet ownership"; "households" and "pets"; "dogs" or "cats" or "pets" and "mental" or "physical health" or "children"; "animal assisted therapy"; "dogs" or "cats" and "nutritional problems" or "overweight" or "obesity" or "homemade" or "raw meat diets"; "dogs" or "cats" and "behavior problems" or "aggression" or "fear" or "anxiety" or "abnormal repetitive behavior"; "dogs" or "cats" and "breeding" or "genetic problems"; "dogs" or "cats" and "zooanthroponoses"; "pets" and "anthropomorphism"; "dogs" or "cats" or "exotic animals" or "rescue dogs" or "soil" and zoonoses. for some topics the internet was accessed and used as reference if additional information was not available as scientific publication. the authors selected articles that described pivotal and novel insights in the different topics. all searches were carried out without filters. the titles of all found articles were screened for relevance to the topic, and appropriate titles were assessed and selected based on their abstracts. if a selected article was a review, it was read and relevant citations were used to find primary literature on the subject. additional studies were found using the bibliographies of selected articles. occasionally, reviews were directly used as sources, mostly to convey background information that is not in the core focus of this article. original articles in english and different national languages (dutch, german, french, spanish, if available) were included. specific searches were made for citations dated after the year to ensure more recent literature on the topic had not been missed. a pet or companion animal is an animal that lives in or around the house and is fed and cared for by humans. until the s, pets were mainly kept as utility animals, for example as draft dogs or watch dogs or for pest control when it comes to cats. due to major changes that have taken place in society since the second world war, such as increased leisure time and prosperity, but also individualization of humans, animals are nowadays kept as pets and are regarded by many owners as valued family members, e.g., over % in the united kingdom [ ] . pet ownership is still increasing in many industrialized countries and these animals are more often considered a member of the family [ ] . even in china, a country where pets were banned in urban areas until , pet ownership has grown quite rapidly in the major cities. the rate of pet ownership of all usa households increased from . % to % in . dogs continue to dominate in popularity among american households. approximately % of households nationwide owned a dog, bringing the population of pet dogs to nearly million, while % of households owned cats, with a total population of million [ ] . in , an estimated million european households owned at least one pet animal; % of households owned dogs and % owned cats [ ] . there are million pet dogs and million pet cats in europe which is a % increase of dogs within years ( million dogs in ) and a % increase of cats ( million in ) [ ] . pet cats in europe thereby are more popular than dogs. an explanation of the higher popularity of cats may be the number of single-person households in the eu that rose on average by . % per annum between and to . %, and the growth of two-family households grew by % to % in this period [ ] . also, dual-earner families are widespread as a result of quite a steep growth in female employment over the past two decades [ ] . when animals live with humans, they too benefit from human interaction. over the past decades, animal welfare has evolved to recognize that animals are sentient beings capable of experiencing positive and negative emotions. the social and ethical dimensions of animal welfare, which are concerned with how human society morally regards and treats non-human animals, are also increasingly being recognized [ ] . in dutch law, the intrinsic value of kept animals is expressly incorporated and used as a guiding ethical principle that forms the basis of any further legislation. the intrinsic value is thereby defined that animals are sentient beings that can feel pain and discomfort. therefore, they should be kept free of stress, pain, disease, hunger, thirst, and should be able to show natural behavior known as the five freedoms of r. brambell [ ] . in industrialized countries animal keepers, their owners, are legally required to provide such circumstances and can be prosecuted if they infringe the law. of course, in the field there is animal abuse, negative animal welfare conditions, and animal diseases. however, in general, caretaking for companion animals is nowadays performed at a high level. new insights into animal behavior has had its influence on the general public. for example, owners are aware or are told by vets and pet shops that rabbits should not be kept alone but at least in pairs due to their need for social contact [ ] . there are various reasons to keep pets, such as love, warmth, and companionship. companion animals have an important emotional value, and promote the socialization of the lonely elderly because they facilitate additional contact with people. pets form a goal in life, reduce stress, and ensure that the owner keeps physically active. around % of dog owners and % of cat owners expressed that owning their pet makes them happy and % of owners selected this as one of the reasons they got their pet in the first place [ ] . however, the function of companion animals consists of more than just providing a socializing being. studies show other benefits of having a pet, such as the positive effect on individuals' mental and physiological health status. most research addressing the health benefits of pet ownership show reductions in distress and anxiety, decreases in loneliness and depression, and increases in physical condition [ ] . the positive benefits to human health from interacting with animals, focusing on the companion animal, have also be described with the term "zooeyia" [ ] . in fact, % of owners agreed that having a pet makes them physically healthier, with dog owners more likely to agree, most probably because dog owners exercise more ( % agreeing, compared to % of cat owners). besides, % of owners agreed that having a pet makes them mentally healthier. expressed reasons are the non-judgmental nature of their pets, their playfulness, or physical contact [ ] . another demonstrated positive influence is the blood pressure and heart rate lowering effects that occurs when stroking a friendly-looking dog or even being in the presence of a friendly animal, while it is not necessary to own a pet to obtain these stress-moderating benefits [ ] . many studies have demonstrated the association between pet ownership and cardiovascular health and dog owners appear to have a significantly greater chance of survival after a heart attack compared to people without pets [ ] [ ] [ ] . pets can therefore play an important role in reducing absenteeism and visits to family doctors or the hospital [ ] . it has been estimated that pet ownership saved australia $ billion in [ ] , while it may reduce the use of the national health service (nhs) in the uk to the value of £ . billion per year [ ] . dogs also play an increasing role as co-therapist or as supporter for people with psychological or physical disabilities. the benefits of these animal-assisted activities are improved mood, decreased physiological distress, depression, dementia, and loneliness [ , ] . examples include resident or visiting dogs in prisons, nursing homes [ ] , mental institutions, and hospitals where they can reduce patient anxiety in a hospital emergency department [ ] , reduce pain perceptions in children after surgery [ ] , or calm young patients at a pediatric dental clinic [ ] . since dogs have extremely sensitive noses, they are used for several purposes such as tracking, bomb detection, and search and rescue. in recent years, canine olfaction has also been more recognized as a diagnostic tool for identifying pre-clinical disease status, such as diabetes (ketones), different forms of cancer, and infections from biological media samples [ ] . animal-assisted therapies can act as co-therapies to facilitate psychotherapy or to provide specific types of therapeutic interventions such as improving motor skills or behavior [ ] . such interventions were effective in improving the state of children or adults with or at risk of developing mental disorders such as attention deficit hyperactivity disorder (adhd), post-traumatic stress disorder (ptsd), or autism spectrum disorder (asd) [ ] [ ] [ ] , and for the treatment of ptsd in military veterans [ , ] . assistance or service animals are trained to perform tasks for the benefit of individuals who have disabilities such as hearing loss, physical disabilities, emotional disabilities, seizure disorders, or diabetes [ ] . finally, a wide range of emotional health benefits from childhood pet ownership has been identified, particularly for those suffering from low self-esteem and loneliness. there is evidence of an association between pet ownership and educational and cognitive benefits, increased social competence, social networks, social interaction, and social play behavior [ , ] . significantly less absenteeism from school through sickness among children who live with pets has also been reported [ ] . having a dog or cat in the house during the first year of life may protect against childhood asthma and allergy [ , ] . it can therefore be concluded that companion animals contribute significantly toward the public health, but also increasingly, the health of individually challenged persons through animal-assisted interventions [ ] . providing companion animals with feed by humans, has been considered an advantage for companion animals in their relationship with humans. however, the feeding practices can also have a negative impact on companion animals [ , ] . obesity in cats and dogs is a disease which is rapidly increasing with significant and lifelong implications for animal welfare. although no universally accepted definition of canine and feline obesity exists, the american veterinary medical association defined obesity being more than % above the ideal weight of an animal. overweight is defined as %- % above the ideal weight. using body condition scores, it has been estimated that in the united states, % of dogs and % of cats are obese or overweight. a study in the united kingdom reported % of adult dogs and % of juvenile dogs as being obese or overweight [ , ] . overweight dogs are more likely to be diagnosed with, e.g., urinary tract diseases. obese and overweight dogs are at risk developing orthopedic disorders and hypothyroidism [ , ] . obese cats are at higher risk for developing urinary tract disease, diabetes mellitus, and neoplasia [ , ] . other diet-related problems in companion animals can be caused by the changed feeding behavior of humans, e.g., by providing companion animals with bone and raw feed (barf) or vegan diets. risks for companion animals associated with barf or vegan diets are the presence of microbial hazards, insufficient nutrition, and in raw meat diets the presence of risk materials like thyroid tissue. through contact with their animals, it is possible that risks could even develop for owners. there could be an increased risk of human salmonellosis because of the presence of salmonella spp. in the diet which can spread to humans through diet leftovers or by contact with animal feces. recently a review was published on the risks of barf feeding [ ] . the authors concluded that the data for the nutritional, medical, and public health risks of raw feeding are fragmentary, but they are increasingly forming a compelling body of formal scientific evidence. publications were found reporting the presence of escherichia coli o , salmonella typhimurium, campylobacter spp., and antibiotic resistant bacteria in the feed. nutritional problems, such as calcium/phosphorous imbalances and specific vitamin deficiencies [ ] are also reported. moreover, homemade diets are inherently susceptible to nutritional imbalances and deficiencies [ ] . awareness about climate change, public health and animal welfare has incited a major change in dietary choices among many individuals. the number of vegans in the world keeps growing, even quadrupling from , to , individuals between and in affluent countries such as the uk [ ] . the popularity of veganism goes beyond the scope of the human diet, as more people are interested in the possibility of feeding their companion animal a vegan diet than ever before. to create animal-free complete cat food requires replacing nutrients in animal-based materials with plant-based materials. different sources are used such as corn, rice, peas, soy, potato, and different oils and seeds. any further nutrients that are missing from plant-based materials, such as taurine and carnitine, are replaced with synthetically produced versions [ , ] . feeding trials using vegan animal food are either not performed due to testing costs or kept private due to the highly competitive vegan pet food market [ ] . additionally, they reported testing vegetarian diets for cats and dogs and found that one was lacking protein and six did not meet all amino acid concentration requirements. vegan animal food may not contain meat, but it does contain grains, soy, and corn. plant-based products, such as grains, can be a source of health problems because of the presence of mycotoxins, for example [ ] . warm, humid storage conditions can lead to the formation of mycotoxins such as aflatoxins, produced by the fungi aspergillus flavus and aspergillus parasiticus. many regular animal feeds also contain plant-based products, therefore the negative impact of feeding vegan diets to companion animals, especially obligate carnivores such as the cat or the ferret, seems therefore more related to diet insufficiency than to microbial health risks. additionally, addressing behavioral problems, the "free" provision of food might fulfil the consumptive part of feeding behavior of our companion animals but does not fulfil the appetitive phase. especially this phase of feeding patterns can have consequences for the companion animals' mental health and may result in behavioral problems if appetitive physical and mental challenges remain chronically absent in the human-animal relationship. in the human-companion animal bond, pets may develop abnormal behavior, including excessive aggression, fear and anxiety, or even abnormal repetitive behavior. abnormal repetitive behavior (arbs) were first noticed in zoo-, shelter-, and laboratory animals: all animals housed under stimulus-poor conditions and with limited space. however, companion animals can develop arbs as well, if the individual's adaptive capacity is exceeded due to, e.g., a lack of social contact, physical exercise, mental challenges, and in uncontrollable and unpredictable environments (e.g., separation, mistreatment, or inadequate application of cages). arbs can either be classified in stereotypies or compulsive disorders [ ] with stereotypies generally defined as unvarying repetitive behavior patterns with no obvious goal or function [ ] . the terminology of compulsive disorders is preferably chosen for repetitive behavior patterns that are goal-directed and show variability in the repetitive (motor) patterns [ , ] . under chronic conditions without possibilities to adapt (cope), companion animals may develop stereotypies or compulsive disorders like, e.g., tail chasing, polyphagia, compulsively self-directed licking and/or biting the coat [ ] , or feather pecking in parrots [ ] . self-directed patterns can result in serious degrees of alopecia, lick granuloma, or even self-inflicted injuries (auto-mutilation) with a risk of infection. two main reasons underlie the development of arbs in our companion animals. first of all, a lot of companion animals are social species eager for social contact. in the human-companion animal bond, the need for social contact with either conspecifics and/or humans [ , ] can remain unfulfilled if owners work from nine to five, five days a week with the pet staying alone at home on a daily basis. on the other hand, a cat which is originally a solitary hunter with a complex dynamic social structure may start overgrooming or house soiling in the presence of another cat in the territory. such situations might occur in multi-cat households, in the presence of neighboring cats, and in in-stable grouped housing conditions in shelters [ , ] . secondly, most companion animals are species that are eager for mental and physical challenges on a daily basis. the lack of foraging opportunities, the appetitive phase of feeding behavior [ ] might be another reason for the possible development of arbs in companion animals. foraging is often regarded as a high priority behavior [ , ] , i.e., an internally motivated behavioral pattern that should be performed, or otherwise may induce a state of chronic stress, which may result in behavioral pathology like arbs as described in many other animal species [ ] [ ] [ ] . foraging patterns may include walking, running, jumping, nose pushing, digging, and overseeing the area, all active patterns that imply the daily need for physical exercise and mental challenges in most of our companion animals. nonetheless, our pets mostly, if not always, get their food for free with minimal foraging challenges, except for going out - times a day. for some individuals (and especially some dog breeds, e.g., malinois, border collies, and pit bull terriers) [ , ] , situations and contexts with limited challenges can make them more vulnerable to the development of arbs. as well as arbs, other problematic behavior may develop in our companion animals, and the prevalence of some of this behavior is even higher than that of arbs, for example excessive interspecific and/or intraspecific aggression, fear, and anxiety. at what moment, and which type of problem behavior may develop, depends on the intermingled factors of, e.g., genetics, early life experiences (maternal-child bonding, weaning, socialization [ ] ), daily environment, and multiple factors in and around the human-companion animal bond. the history of breeding animals goes back to a time when humans and animals shared each other's habitat. dogs originally have been selectively bred to support human needs, such as hunting, herding, obedience, guarding, rescuing, and for companionship. this artificial selection has generated a large number of dog breeds, displaying a large variation of behavior, size, head shape, coat color, and coat texture [ , ] . unfortunately, in the last years, intensive selection for extreme looks and a narrow gene pool of many breeds has interfered in the genetic make-up of dogs, leading to unfavorable anatomy (extreme large, or extreme "teacup" small), and genetic predisposition to numerous health, welfare, and behavioral problems [ ] . over inherited disorders and traits have already been described in the domestic dog [ ] . one type of dog with a distinct dysmorphology is the brachycephalic dog. brachycephalic dogs are characterized by a large head and round face due to a shortened muzzle, a high and protruding forehead, and widely spaced large eyes. these facial features fit the concept of baby schema ("kindchenschema") proposed by konrad lorenz [ ] . infantile (cute) faces are biologically relevant stimuli for rapidly and unconsciously capturing attention and eliciting positive or affectionate behavior, including the willingness to care [ ] . the appeal of brachycephalic animals has led to specimens that are the so-called "over-typed" dogs and cats with a too short nose, excessively protruding eyes, too straight angulations, etc. breeding animals with this type of severe skull and muzzle abnormalities leads to physical and physiological hardship and limits their natural behavior [ , ] . this violates their integrity and is a big risk for their welfare. selectively breeding animals in order to express specific traits does not only alter existing animals, but also creates new ones, turning animals into an instrument for human use [ ] . the bambino sphynx cat is an example of so called "mutant breeding", where breeders deliberately stack in two steps the recessive inheriting mutations, which leads to hairlessness in sphynx cats, on the dominant inheriting (lethal) mutation responsible for the shortened legs of the munchkin cat. the lack of hair in combination with short legs interferes with the normal physiology of the cat with regard to the manner of movement, thermoregulation, and skin health. one may argue that artificial selection in exchange for money, status, or aesthetic reasons violates the animal's dignity and integrity [ ] . conclusively, artificial selection for excessive traits can have direct consequences for individual health and welfare, may obstruct and prevent a pet from fulfilling its behavioral needs, and conflicts with the current moral way of thinking on animal dignity and integrity. pet animals are not only perceived in %- % as family members or partners but are almost treated like humans. in one study, up to % of owners agreed with the statement "my dog is more important to me than any human being" [ ] . this kind of behavior is the result of the attribution of human cognitive processes and emotional states to animals, such as feelings of happiness, love, or guilt. people believe that animals have awareness, thoughts, and feelings. this behavior is called anthropomorphism, personification, or humanization and can also be applied to plants, gods, or objects. anthropomorphism appears to be caused by the perceived similarity between humans and animals and the extent to which people have developed an affectionate bond with their dogs and cats [ ] . human empathy provides the basis for the attribution of empathy to other animals, as well as attributions of the communicative ability of other animals [ ] . anthropomorphistic behavior can be harmless, such as talking to pets, which many owners do and one of the reasons for this may be the unique ability of humans to recognize facial expressions. talking to pets is also found to be linked to social intelligence [ ] . however, it can lead to animal welfare problems when the feelings of owners no longer match the needs and the intrinsic values of their animal. examples of this are designer dog clothes, animal perfumes, and jewelry, thought the use of protective coats in colder climates for small, short-haired breeds, e.g., chihuahuas, is considered useful. the large number of obese pets can also be partly attributed to anthropomorphism. studies from north america, europe, and australia to determine what proportion of animals, mainly dogs, are overweight or obese reported prevalences of between %- % [ ] . in , an estimated % of cats and % of dogs in the usa were overweight or obese [ ] . when the owner takes a treat with coffee, it is believed that the dog should also get it. even chocolate treats are given, when these are potentially fatal for dogs and cats. this also applies to a good meal that is shared with the pet. dog owners who did not consider obesity to be a disease, maybe because the facial features of their pets fit the concept of baby schema [ ] , were more likely to have obese dogs [ ] . an often-unrecognized risk for pets is reverse zoonotic disease transmission, the so-called zooanthroponosis. a review on this subject reported articles dealing with human to animal disease transmission [ ] . most of the articles dealt with bacterial pathogens but also viral, parasitical, and fungal pathogens were studied in these publications. animals reported to have been infected or inoculated with human diseases included wildlife, livestock, companion animals, and other animals or animals not explicitly mentioned. the majority of the studies focused on human to wildlife transmission with an emphasis on mycobacterium spp. for companion animals, mrsa-infection was especially reported but m. tuberculosis, influenza a, and candida albicans were also discussed. for all groups of animals, microsporum spp. and trichophyton spp. were identified as infectious agents originating from humans [ ] . recent publications report a different kind of zooanthroponosis: the transmission of high-risk, multidrug-resistant pathogens from humans to animals [ ] . a major issue mentioned is the transmission of high-risk clones of extended-spectrum beta-lactamase (esbl) producing bacteria including escherichia coli, enterobacter cloacae, and klebsiella pneumonia [ , ] . the transmission of carbapenem-resistant ndm- producing e. coli from previously hospitalized humans to dogs has also been suggested [ ] . transmission of hospital acquired antibiotic resistant bacteria from human patients to their pets has been confirmed, such as the vim- producing pseudomonas aeruginosa st strain in brazil [ ] . this increased transmission of high-risk multidrug-resistant pathogens from humans to animals was related to the closer relationships between humans and companion animals. some authors doubt the generalized pet-effect on human mental and physical health because of conflicting results that are prevalent in this area of science and the lack of publication of negative results [ , [ ] [ ] [ ] . the majority of research evidence was also considered inconclusive due to methodological limitations such as reliance on self-reports, small sample sizes that may not be representative of the general population, homogeneous populations, varying research designs, narrow range of outcome variables that were examined, and the use of cross-sectional designs that do not consider long-term health outcomes [ ] [ ] [ ] . other studies found for example that pet ownership was associated with a higher incidence of heart attacks and readmissions in heart attack patients instead of a lower incidence [ ] or that pet owners had higher diastolic blood pressure than those without pets [ ] . müllersdorf ( ) showed that pet owners had better general health but suffered more from mental problems such as anxiety, insomnia, and depression, than those who did not own pets [ ] . other studies failed to support earlier findings that pet ownership is associated with a reduced use of general practitioner services [ ] or psychological or physical benefits on health for community dwelling older people [ ] . negative effects of pet ownership include dog and cat bites or scratches, the spreading of disease (zoonoses), and fall injuries, caused by falling or tripping over dogs and cats [ ] . allergic reactions may be a consequence of animal contact and affect %- % of individuals (often genetically) predisposed [ ] . allergies relating to more uncommon pets such as fish, birds, and amphibians seem to be increasing in prevalence [ ] . other studies prove that pet ownership in early life did not appear to either increase or reduce the risk of asthma or allergic rhinitis symptoms in children aged - years. therefore, advice to avoid or to specifically acquire pets for primary prevention of asthma or allergic rhinitis in children should not be given [ ] . there are also less-positive effects that pets can have on health. more excessive forms of anthropomorphism became clear in our study for the presence of zoonotic parasites in healthy dogs and cats. fifty percent of owners allow pets to lick their faces. sixty percent of the pets visit the bedroom; - % (dogs-cats) are allowed on the bed, and - % (dogs-cats) sleep with their owner in bed. six percent of pets always sleep in the bedroom. of the cats, % are allowed to jump onto the kitchen sink [ ] . this means that in addition to the detected zoonotic parasites (the hazard), there was a significant potential exposure to these pathogens. in addition to parasites, other pathogens such as bacteria, viruses, and fungi can also be transmitted by animals by direct contact through biting, licking, scratching, sneezing or coughing, handling pets or their body fluids or secretions and by indirect contact through contaminated bedding, food, water, or bites from an arthropod vector [ ] . not every individual will develop symptoms after being infected with a zoonosis. this is the result of various factors such as the causative pet species, housing, the degree of contact and contamination, the ability of a micro-organism to cause disease in humans and animals, but especially due to the degree of immunity of the recipient. in order to assess the risk of disease transmission from pets it is important that the nature and frequency of contacts between pets and their owners or other people are evaluated [ ] . we traditionally know that young children (age < years), the elderly (age ≥ years), patients with an impaired immunity, and pregnant women that carry a fragile fetus are at more than average risk of becoming ill after an infection. moreover, they may have more severe disease, have symptoms for a longer duration, or develop more severe complications compared to other patients. young children (notably those aged - years) and some people with developmental disabilities often have suboptimal hygiene practices or higher risk contact with animals which further increases risk [ ] . in children, hand-to-mouth behavior is part of their natural development and they mouth their fingers and other objects. in a meta-analysis, the average indoor hand-to-mouth frequency ranged from . to . contacts/hour and the average outdoor frequency ranged from . to . contacts/hour. the lowest value was attributed to the -to -year-olds and the highest to the -to < -month-olds [ ] . fifteen percent of dog owners and % of cat owners always wash their hands after contact with the animals [ ] . in addition, due to improved healthcare in recent decades, the group of immunocompromised patients has increased sharply. this includes, for example, patients with diabetes, post-splenectomy, after placement of implants and patients being treated with chemotherapy or immunosuppressants. the risk groups are also referred to as yopis (young, old, pregnant, and immune suppressed). patient surveys and epidemiological studies suggest that the occurrence of pet-associated zoonotic disease is low overall [ ] . many of these pathogens are not reportable and presumably underdiagnosed or not recognized by family doctors due to the general, mostly flu-like, symptoms. therefore, any reported frequency of such infections is likely underestimated. to get a better picture of zoonotic risks, a risk analysis is required where a risk score can be calculated using exposure, contagiousness of the infection, and its consequences in the human. in addition, the disease burden of an infection for the population can be calculated and expressed in disability adjusted life years (dalys). this quantifies the health loss based on two components: the life years lost due to premature death and secondly the proportional loss of quality of life as a result of the disease. there is a trend towards closer physical contact between owners and their pets or their environment which poses an increased risk of transmission of zoonotic pathogens. these trends (a general direction in which something is developing or changing) will be explained. our publication [ ] showed that a high percentage of pets were allowed in the bedroom and in bed, with % always sleeping in bed with their owner. is that a problem? already from a hygienic point of view, it is not advisable to sleep with animals or take them into bed. they do not pay attention to where they are walking outside and do not wipe their feet after arriving home. dogs like to roll in carcasses and both dogs and cats regularly lick the anus and thereafter the fur. in a pilot study with healthy dogs and healthy cats that slept with their owners, we tested % of the dogs ( ) and % of the cats ( ) positive for enterobacteriaceae on the fur or footpads. fleas and flea larvae were found on % of pets [ ] . as a result of our publication, chomel investigated in whether transmission of infections by sleeping with pets and licking the face could be found in literature. he reported that also in the usa, france and the uk, a relatively large number of pets slept in bed with their owner ( %- % of dogs and %- % of cats) [ ] . similar results of sleeping with pets were also reported from canada ( % of pets slept with children), the czech republic ( %), and qatar ( . %) [ ] [ ] [ ] . chomel found bacterial infections such as yersinia pestis (plague), bartonella henselae (cat scratch disease), methicillin-resistant staphylococcus aureus, and sometimes fatal bite wound infections such as capnocytophaga canimorsus and pasteurella multocida. furthermore, parasite infections such as cheyletiella spp. were reported. feline cowpox is a rare viral infection, but it can be transferred to the human after direct contact. both animals and humans reveal local exanthema on arms and legs or on the face. in most cases the disease is self-limiting, but immunosuppressed patients can develop a lethal systemic disease resembling smallpox [ ] . it can be concluded that, although uncommon with healthy pets, the risk of transmission of zoonotic agents by close contact between pets and their owners through bed sharing is real and has even been documented for life threatening infections such as plague [ , ] . although pets do not transmit arthropod-borne diseases to people (e.g., lyme borreliosis, ehrlichiosis, anaplasmosis), they do bring zoonotic disease vectors such as ticks and fleas, in close proximity to people, e.g., when they are sleeping with their animals [ ] . while fleas are considered a vector of bartonella henselae (the causative agent of cat scratch disease) tickborne diseases are reported as increasing as ticks expand their ranges [ , ] . with an estimated , cases a year, lyme borreliosis is responsible for the largest disease burden of any vector-borne disease in the european union [ ] . another increased risk associated with close contact with fur is when it is contaminated with zoonotic parasite eggs. especially with echinococcus multilocularis (fox tapeworm) or e. granulosus (hydatid worm, or dog tapeworm). these eggs are immediately infective and may cause serious health problems in the human, many years post infection [ , ] . despite a low prevalence of infectious (embryonated) eggs of toxocara spp. on dog's fur, the potential zoonotic risk should not be disregarded [ ] . the same risk is applicable for the persistence of sporulated toxoplasma gondii oocysts in dogs' fur [ ] . in relation to this, it is noteworthy that many publications report striking increases of ringworm, a common zoonotic fungal skin infection in mainly children caused by microsporum spp., trichophyton spp. or arthroderma spp., where the presence of pets is always mentioned [ ] . however, nowhere has it been suggested that close contact with infected pets in bed increases the infection risk [ , ] . rodents or rabbits are mainly infected with t. mentagrophytes, while m. canis is primarily found in dogs and cats. infection occurs by direct or indirect contact with infected hair, scales, or materials. infected animals may be asymptomatic carriers without clinical signs. examples are % m. canis carriage in a study of european cats [ ] , % in suspected brazilian cats [ ] , and the isolation of t. mentagrophytes dermatophytes from % of clinically healthy rabbits and % of guinea pigs in dutch pet shops [ ] . licking the face of humans by mainly dogs is an expression of their naturally submissive, positive social behavior. the owner is recognized by the dog as the dominant superior in the ranking. in a pack of dogs, submissive dogs lick their dominant counterparts at the corners of the mouth from a typical submissive attitude [ , ] . owners apparently allow this as a token of affection from their pet. such behavior is more common in young animals and has been considered as attention-seeking or care-soliciting gestures. it indicates to the owner the strength of the social bond between dogs and people [ ] . licking or nudging of veterans by service dogs may help take their mind off any negative thoughts, emotions, or memories that they might be experiencing [ ] . on the internet, many images can be found of mainly dogs, but also cats and even rats licking their owner's face. various studies show that around %- % of owners allow this [ , ] . the question is whether this is harmful due to the potential transmission of infections. the review by chomel ( ) shows in the literature that infections, especially pasteurella spp. and capnocytophaga canimorsus, were reported to have transmitted to humans by dogs, cats, kittens, and rabbits [ ] . pasteurella multocida meningitis has been reported in infants where % had been exposed directly or indirectly to the oropharyngeal secretions of household dogs or cats through licking or sniffing [ ] . zoonotic transmission via this route is also assumed for various other pathogens such as gastric helicobacter spp. [ ] , periodontal pathogens [ ] , and bartonella henselae the etiological agent in cat scratch disease. the b. henselae bacteria may cause ocular complications, including parinaud oculoglandular syndrome, a severe eye infection. the route of infection is unknown, although direct conjunctival inoculation, most likely with infected flea feces, seems to be most plausible [ ] . knowing, however, that b. henselae is present in up to % of cat saliva [ ] , it is more plausible that salivary fluid could be rubbed directly into the eye from the skin after been licked by a cat. there are several anecdotal reports of infections in mainly young children that were transmitted by being licked. one recent example is an -month-old baby that presented with fever and preseptal cellulitis with purulent discharge. the causative agent was surprisingly corynebacterium bovis, a bacterium that is normally found in bovine mastitis. it became clear that the dog was frequently allowed to lick the baby's face and was fed on raw meat [ ] . there is an ineradicable belief among a large part of the public that the licking of human wounds by dogs can disinfect them and that the saliva thereby has healing properties [ ] . in addition, it is regularly reported that a dog's tongue is believed to be sterile. this is of course not the case and the oral flora of a dog comprises hundreds of species (including pathogenic) bacteria, fungi, and viruses [ , ] . various wound healing saliva components have indeed been demonstrated in human and animal studies [ , ] . the bactericidal effects of male and female dog saliva facilitate the hygienic function of maternal licking of the mammary and anogenital areas by protecting newborns from fatal coliform enteritis caused by e. coli and neonatal septicemia caused by streptococcus canis. however, the saliva is only slightly, and non-significantly, bactericidal against wound bacteria such as coagulase positive staphylococci and pseudomonas aeruginosa [ ] . capnocytophaga canimorsus and pasteurella multocida are common commensals in the oral cavity of dogs, cats, and other species [ , ] . transmission has been reported after the licking of mucous membranes or open wounds [ ] [ ] [ ] . in patients at high risk, severe wound infections, sepsis, disseminated intravascular coagulation, or death can occur. patients with immunodeficiency, splenectomy, or alcohol dependence are at a particularly increased risk of infection with c. canimorsus [ ] . even immunocompetent persons who have been licked by a dog can develop fatal sepsis [ ] . a further negative effect of companion animal ownership is, of course, accidents inflicted on humans by these animals. these accidents can involve tripping over a cat or being dragged by an enthusiastic dog, but in literature, most evidence points towards biting and scratching incidents. dog biting and cat scratching incidents can cause physical health problems both at the time of infliction but also afterwards by triggering trauma-related secondary infections. dog biting incident reports are numerous, and numbers vary from country to country. in the uk, . dog bites per population per year were reported [ ] , while a commission in the netherlands reported in , , bite accidents per year in a population of million ( events per inhabitants) [ ] . children are especially vulnerable to dog bites. the majority of dog bites occurred in children years of age or younger ( . %) and almost all ( . %) of the dogs were known to the children [ ] . recently, a systematic review has been published that analyzed more than , bites from the literature of the past years about the risk of bites relative to specific breeds of dogs, combining bite incidence with bite severity [ ] . the analysis by breed revealed that pit bulls were responsible for the highest percentage of reported bites across all studies ( . %), followed by mixed breed ( . %), and german shepherds ( . %). dog bite incidents can result in medical treatment, hospitalization and even death. in the netherlands it was calculated that from the , dog bite victims per year, around , seek medical attention and are hospitalized [ ] . between % and % of dog bites become infected and complications become more severe when infection occurs. more than species of bacteria have been isolated from bacterial infections of dog bites, suggesting that most oral flora of dogs have the potential to be pathogenic [ ] . the top pathogens found are pasteurella, staphylococcus, and streptococcus. in literature, specific attention is given to wound infections caused by capnocytophaga canimorsus, because this bacterium is seen as the relatively deadliest pathogen. it was suggested that only % of dog bite wounds contained capnocytophaga spp. [ ] while others reported infection percentages of . % [ ] . wound infection with this bacterium can lead to severe complications like septicaemia, meningitis, osteomyelitis, peritonitis, endocarditis, pneumonia, purulent arthritis, and disseminated intravascular coagulation. c. canimorsus septicaemia has been associated with % mortality. the true number of c. canimorsus infections is probably largely underestimated due to the fastidious growth of the organism. however, infected dog bites in predisposed persons should be taken seriously especially after splenectomy [ ] . cat bite incidents occur less frequently. in only %- % of reported bite incidents in australia, cats are to blame. the long incisor teeth inflict less severe superficial wounds but because of the penetrating effect, joint and tendon infections more easily occur. in a review it is reported that %- % of cat bites become infected mostly by pasteurella multocida [ ] . the bacterium bartonella henselae can also be transmitted by cats through biting incidents but the transmission of this bacterium is much more related to a cat scratch accident. even less frequently reported animal biting incidents are those inflicted by rodents ( % of cases in australia). these bites have an infection rate of approximately %. this could result in rat bite fever in humans, an infection with streptobacillus monoliformis or spirillum minus, characterized by the triad of fever, rash, and arthritis [ ] . cat scratch disease (csd) was first described in a french boy in and is a common, often self-limited, disease that usually presents as tender lymphadenopathy caused by bartonella henselae [ ] . the cat is considered the primary reservoir for this bacterium, with infected fleas and ticks serving as vectors and humans and dogs as accidental hosts. vector transmission of this bacterium occurs via two primary routes: inoculation of bartonella contaminated arthropod feces via animal scratches, most often cat scratches, or by self-inflicted contamination of wounds induced by the host scratching arthropod bites [ ] . immunocompromised human hosts (kidney transplant patients or patients with hiv) are especially susceptible to infection. in these individuals, the disease may be present as a more disseminated form with hepatosplenomegaly, meningoencephalitis, or angiomatosis [ ] . an increasing number of pocket pets and exotic pets are kept by humans. numbers of ornamental birds in europe are estimated as million, fish tanks . million ( million ornamental fish), small mammals million, and reptiles million [ ] . these animal species can also be a source of many zoonotic diseases, especially in young children and immunocompromised individuals. most cases of these conditions are not serious, and deaths are very rare but some of these diseases can be life threatening, such as rabies, rat bite fever infections, and plague [ ] . however, there is also a trend to keep more unusual exotic animals, legally or illegally. these are "wild" animals that are kept in the home such as bats, foxes, skunks, raccoons, meerkats, prairie dogs, kinkajous, sloths, monkeys, apes, prosimians (mammals), parrots, mynah birds, finches (birds), crocodiles, turtles, tortoises, lizards, snakes (reptiles), frogs, toads, newts, salamanders (amphibians), fish, eels, rays (fish), crabs, crayfish, snails, insects, spiders, and millipedes (invertebrates) [ ] . even fruit bats are kept as pets [ ] and it is known that bats harbor a higher proportion of zoonoses than all other mammalian orders, including rabies-like viruses that are highly pathogenic for people. [ ] . another example of a zoonosis is monkeypox following the importation of prairie dogs in the usa [ ] . most reptiles and amphibians such as turtles, lizards, and frogs carry salmonella bacteria in their gut, in most cases without visible signs of infection. the infection may cause symptoms of sickness, diarrhea and fever in humans [ ] . zoonotic transmission of salmonella infections causes an estimated % of salmonellosis annually in the united states. in cases involving pet turtles, almost half ( %) of infections occurred in children younger than years [ ] . salmonella infections are often transferred by feeder rodents [ ] and outbreaks highlight the importance of improving public awareness and education in countries who receive imported reptiles [ ] . it is advised to exclude reptiles, amphibians, rodents, exotic species, baby poultry, and raw animal-based pet food items from the households of patients at high risk. in lower risk households, an understanding of the risk of salmonellosis and other pet-associated zoonoses and preventive hygiene measures is needed. the pet trade in general, with its high turnover and diversity of available species, creates a reservoir for pathogens originating from all over the globe. reptiles account for approximately % of live animal shipments imported to the united states [ ] . importation of live reptiles and amphibians for commercial purposes is for a great part unregulated at eu level except cites and customs regulations [ ] . in a risk assessment study, the five pathogens with the highest public health risk caused by the import of exotic animals were salmonella spp., crimean-congo hemorrhagic fever virus, west nile virus, yersinia pestis, and arenaviruses. the risk via legally imported animals was considered low, but substantial for illegally imported animals due to the unknown health status of the animals [ ] . avoiding exposure to exotic pet pathogens in the home is difficult and best achieved by not keeping them in the first place. otherwise, it is advised to always wash the hands immediately and thoroughly after contact with exotic pets and after handling raw (including frozen or defrosted) mice, rats and chicks. children should be supervised so that they do not put their mouths close to or kiss exotic animals. reptiles and other animals should be kept out of rooms in which food is prepared and eaten. the number of abandoned and homeless dogs and cats in europe is estimated to be over million. countries with more than million abandoned animals are italy, romania, russia, and ukraine [ ] . there is an increasing trend to rescue and import dogs from countries with stray animal problems, in europe often from southern or eastern europe and in the us from puerto rico, the dominican republic, mexico, the middle east, turkey, china, and korea [ ] . many charities and independent groups are involved to rescue dogs and seek adoption in more animal-friendly countries [ ] . new owners primarily choose to adopt from abroad based on a desire for a particular dog they had seen advertised and on concern for its situation, while some were motivated by previously having been refused dogs from local rescues [ ] . in the usa % of all household dogs were neutered and today there are no longer enough dogs being born in the usa annually to replace the approximately million dogs that die each year. developing countries have hundreds of millions of street dogs available for export, for example egypt has an estimated million, india, million, and afghanistan, million [ ] . in , more than a decade ago, the centers for disease control (cdc) estimated annual dog imports at around , . today the number of imported dogs is estimated to be more than a million a year [ ] . imported dogs are reintroducing diseases and parasites that were previously eliminated in the usa [ ] . in the usa new and lethal strains of distemper and canine influenza as a result of imported rescue dogs were reported as well as canine brucellosis, rabies, and vector-borne diseases like ehrlichiosis, heartworm, babesiosis, and leishmaniasis [ , ] . in many southern european countries, there is also a risk of exposure to diseases not encountered in the northern, importing, countries. animals could be infected with anaplasma phagocytophilum, babesia canis, brucella canis, borrelia burgdorferi, dirofilaria immitis (heartworm), dirofilaria repens (subcutaneous worm), echinococcus multilocularis (fox tapeworm), echinococcus granulosus (hydatid or dog tapeworm), ehrlichia canis, hepatozoon canis, leishmania infantum, linguatula serrata (tongue worm), onchocerca lupi, rabies, rickettsia conorii, strongyloides stercoralis, and thelazia callipeda. except b. canis, e. canis, and h. canis, the infections are zoonotic and regularly reported [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . most of these are transmitted by ticks, sand flies, or mosquitoes that are non-endemic in the receiving countries, but a reservoir of infections has been created and the risk is that vectors will become present as result of climate change. [ ] . animals that are infected with rabies or echinococcus spp. may infect people directly. the importation of dogs from endemic, predominantly mediterranean, regions to northern europe, as well as travelling with dogs to these regions carries a significant risk of acquiring an infection. pet owners are therefore advised not to travel with dogs and to seek the advice of their veterinarian prior to importing a dog from an endemic area or travelling to such areas [ ] . for this reason, esccap developed maps on their website featuring european countries and regions with advice on endemic parasites, diseases and recommended treatments when travelling with dogs [ ] . a three-year european union funded project entitled callisto (companion animal multisectorial interprofessional and interdisciplinary strategic think tank on zoonoses), has investigated zoonotic infectious diseases transmitted between companion animals and humans and food producing animals [ ] . the committee advised that special attention should be given to stray cats and dogs. stray dogs, in particular, may pose serious health and welfare problems for humans and animals [ ] , including the transmission of zoonotic diseases such as rabies. consideration should be given to controlling companion animal movement between areas of the eu endemic for particular zoonoses and areas that are not currently endemic for that disease. reliable figures are not available, probably because of the fact that many voluntary organizations are responsible for saving and transporting these rescue animals. such data are essential in order to be able to quantify the actual risks of zoonotic diseases attributable to companion animals and to develop sustainable interventions to prevent transmission to humans and livestock [ ] . as long as there are no official guidelines, to prevent the spread of (zoonotic) diseases to new countries, the time, expense, disease risk, and the implications of adopting a dog from abroad should all be carefully considered before importation. as an alternative, the conditions for native dogs could be improved by supporting local charities to organize neutering campaigns and rehoming programs, to build local animal shelters and to improve attitudes towards dogs and their living conditions [ ] . cats and dogs harbor the enteric nematodes toxocara canis and toxocara cati, and cats are the final host for the protozoal parasite toxoplasma gondii. these parasites can be transmitted to humans because they have an oral-fecal transmission cycle. humans can be infected by ingestion of infective toxocara spp. eggs or toxoplasma oocysts from contaminated soil (gardens, sandpits, and playgrounds) [ , ] . a recent meta-analysis of data from published records indicates that public places are often heavily contaminated with a pooled global prevalence of toxocara eggs of % [ ] . both parasites are considered by cdc as part of five neglected parasitic infections. these infections are considered neglected because relatively little attention has been devoted to their surveillance, prevention, and/or treatment. the diseases that they cause have been targeted as priorities for public health action based on the number of people infected, the severity of the illnesses and the ability to prevent and treat them [ ] . tens of millions of people worldwide are estimated to be exposed to, or infected with, toxocara spp. and recent findings suggest that the effect of toxocarosis on human health is increasing in some countries. almost one fifth ( %; . billion individuals) of the world's human population is seropositive to toxocara. the highest seroprevalence rates were found in africa (mean: . %) and the lowest in the eastern mediterranean region (mean: . %) [ ] . toxocara larvae migrate into the body of the human to several organ systems with a preference for the central nervous system (brain, eyes). human toxocarosis can manifest itself as syndromes known as visceral larva migrans, ocular larva migrans, neurotoxocarosis, and covert or common toxocarosis [ ] . asthma is one of the most common chronic respiratory diseases worldwide, with a negative impact on the quality of life and socio-economic status of patients. two decades ago, the first evidence was published that suggested that toxocara infection is a neglected risk factor for childhood asthma [ ] . the finding that children infected with toxocara spp. are more likely to have asthma compared to non-infected children was recently confirmed in a systematic review and meta-analysis [ ] . cognitive or developmental delays in children or young adults who become infected is of particular concern. toxocarosis appears to be associated with decreased cognitive function [ , ] . the annual toxoplasma oocyst burden measured in community surveys has been reported as up to oocysts per square foot ( per square meter) and is greater in areas with loose soil, that cats like to use to cover their feces in gardens, children's play areas, and especially sandboxes, also called sandpits and sand piles [ ] . because a single oocyst can possibly cause infection, this oocyst burden represents a major potential public health problem. an estimated one third of the world's population harbor anti-toxoplasma antibodies. due to keeping pigs indoors, more education and awareness, the prevalence of the disease in the usa and europe declined by % over the last decades [ ] . during an acute invasion of toxoplasma parasites there is mild to major tissue damage without clinical symptoms (latent toxoplasmosis). the most important form is congenital toxoplasmosis when a woman receives her first exposure to toxoplasma during pregnancy. in early pregnancy, this can lead to abortion or to malformations that are not compatible with life shortly after birth. congenital infections may also be characterized by mental retardation and ocular defects. acquired infection after birth may result in clinical symptoms such as lymphadenitis, fever, and malaise and probably leads to a clinically symptomatic disease state more frequently than the congenital condition, with an estimated incidence of % of all ocular toxoplasmosis cases [ ] . playing in a sandbox is also found to be a predominant risk factor for s. typhimurium salmonellosis in children aged - years [ ] . this can be the result of fecal contamination of the sand by dogs and cats that have been fed raw meat (see section . . .). young children are especially at risk as they put their hands or other objects in their mouths every - min [ ] . it has also been reported that children ingest a median of mg of soil per day and that one child consumed - g of soil per day on average [ ] . it is therefore advisable not to let children play in public places or on playgrounds with loose sand, but only in sandboxes that can be covered. furthermore, washing hands after playing outside is important and fingernails must be trimmed to prevent sand being left behind. in this context, a strange trend can be observed as young children play in mud baths on june "as a way to connect and celebrate the natural joys of playing in the mud". this international mud day originated in and was initiated by an australian pedagogue who had observed this phenomenon during a visit to nepal [ ] . if the origin of the soil needed for producing the mud is unknown, there is of course an infection risk for the above discussed parasites. to prevent the transmission of zoonotic diseases from pets, risk analysis is of great value. this starts with an assessment of the potential zoonoses in an area, depending on the endemicity (the hazard, h). hazard characterization also includes prevalence in animals (the reservoir), virulence for man, transmission routes, and survival of the agent in the environment. the second step is exposure assessment (e). who is exposed to the potential hazard and for how long or how often? how much of the potential pathogen is needed to become a health risk? this inevitably is directly related to human behavior in relation to their pets. the third step is to assess the impact of getting infected (i). how serious is the disease, what is the chance of complications, and what economic consequences may be expected (e.g., labor hours lost)? each of the parameters can be ranked in classes from negligible to the most serious possibility. ranking is based on literature data, own observations (measuring), or experts' opinions. the final risk assessment can be achieved by multiplying the outcome of hazard characterization, exposure assessment and impact (h × e × i = a number). the outcome can be compared with other zoonotic agents and a ranking of significance can be made [ ] . there is one important parameter to reduce the risk of contracting a zoonotic infection that can directly be influenced, which is exposure. recommendations are particularly targeted to households with very young children, the elderly, pregnant women, or immunocompromised patients. they are based on reducing exposure to hazards and involve four categories of advice (table ) . table . recommendations to prevent the transmission of zoonotic pathogens from pets [ , ] . • washing the hands thoroughly -after animal contact, at least before eating and drinking and before preparing food or drinks -after handling raw pet food -after handling pet habitats or equipment -after cleaning up feces -after removing soiled clothes or shoes reflecting on the changed human-companion animal bond, it can be concluded that pets undoubtedly have a positive effect on human health. conversely, the human-pet bond seen nowadays is facing many challenges, putting pet welfare under more pressure due to issues such as anthropomorphism, which mainly results in obesity, breeding on extreme appearance rather than health, behavioral problems connected to unfulfilled species specific mental and physical needs, and the provision of inadequate food because owners mistakenly think they feed more naturally. with regard to the negative effects of pets this article attempts to give an impression of increasing trends in the human-companion relationship that can be observed in society, which appears to increase the risk of transmission of infection between pets and humans. it is mainly a consequence of the increasing contacts between humans and pets and with pathogens secreted by animals in the shared environment. more than out of every known infectious diseases in people can be spread from animals, and out of every new or emerging infectious diseases in people come from animals [ ] . the recent pandemic of the covid coronavirus (sars-cov- ), that may be originated from bats, is a good example of a recent emerging zoonotic infectious disease. a few cats and dogs have tested positive but are not considered as a source of infection for people. the proportion of zoonotic human disease that is attributable to pets is largely unknown. reports about the frequency of such infections are likely underestimated [ ] ; however, the risk of infection is relatively small for many zoonoses and the severity of the disease is often limited. a person's age and health status may affect their immune system, and thereby increase his or her chances of getting a disease from animals. pregnant women should avoid contact with pet rodents, reptiles, cat feces, and raw meat to prevent infection of the unborn child, abortion, or birth defects. if symptoms occur in immunocompetent, non-pregnant persons between and years of age, these are mainly of a general nature such as diarrhea or flu-like symptoms. physicians do not regularly ask about the presence of pets or pet contact, nor do they discuss the risks of zoonotic diseases with patients, regardless of the patient's immune status, which means that many cases of zoonotic diseases go undiagnosed. the general public and people at high risk of pet-associated disease are not aware of the risks associated with high risk pet practices or recommendations to reduce them. since unfamiliarity with hazards reinforces fear, communication plays an important role in this. veterinarians play a key role in education regarding risk reduction by giving advice about responsible pet ownership and the required preventive hygiene. healthcare providers such as family doctors, school doctors, and pediatricians can also provide information about safe pet ownership. physicians should ask as part of the medical history about eventual contact with pets, particularly with patients at high risk [ ] . the "one health" initiative aims to reduce this professional gap between vets and physicians [ ] . when giving recommendations to prevent zoonotic transmission, one of the often-made remarks is that people nowadays are already too hygienic. it is assumed that there is a protective influence of postnatal infection and that it might be lost in the presence of modern hygiene. this belief is based on the hygiene hypothesis that was formulated in [ ] . it was observed that hay fever in young adults was inversely related to the number of siblings in their family. this hypothesis focused exclusively on allergic conditions as a result of the modern way of life and the assumption that modern hygiene was reducing contact with bacteria. another view is that some chronic inflammatory disorders have increased over the last decades as a result of decreased frequency of infections due to pathogenic organisms [ ] . another related theory is the "old friends" mechanism that is based on the positive influence of gut parasites, non-pathogenic environmental bacteria (saprophytes, pseudocommensals), and gut commensals or microbiota. however, decreased exposure to these microorganisms is not the only reason for the increasing frequency of allergies and chronic inflammatory disorders in industrialized countries. nowadays there is more information about the immunological roles of skin, oral mucosa, and gut microbiota as well as helminths and the influence these have on the immune system [ ] . gut flora may be modified due to diet, obesity, hygiene, antibiotics, but also to psychological stress, vitamin d deficiency, and pollution [ ] [ ] [ ] . pollution also has a significant effect on the development of several respiratory problems and diseases. not only due to outdoor pollution such as fine dust, harmful solids, liquids, or gases [ ] , but also due to indoor molds as result of insufficient ventilation in energy efficient homes [ ] . finally, there is a clear increase in the allergen production of house dust mites and pollen leading to more exposure and sensitization in susceptible individuals [ ] . all together it must be clear that there is much more known about other causes of increasing allergies worldwide than simply excessive cleanliness as suggested in the hygiene hypothesis. regarding field infections with helminths such as trichuris trichiura in early life, these are associated with a reduced prevalence of allergies later in life and infants of helminth-infected mothers have a reduced prevalence of eczema. hookworm infections in developing countries are associated with a reduced prevalence of asthma [ ] . the rate of eczema in such countries was found to be about five times higher in infants whose mothers had never had helminths compared with persistent helminth-infected mothers [ , ] . helminths are nowadays even used under controlled conditions to stimulate immunity. examples are trichuris suis therapy for crohn's disease and necator americanus larvae to treat crohn's disease and other autoimmune disorders [ ] . there are no clinically apparent childhood infections found to be associated with protection from allergic disorders [ ] . it can even result in an opposite effect in the case of toxocara infection by children after soil contact. a recent meta-analysis showed that children infected with toxocara spp. are more likely to have asthma compared to non-infected children [ ] . this parasite and asthma both have elevated immunoglobulin e (ige) levels and eosinophilia in common. that means that precautions should be taken in children to prevent soil contact not only to prevent toxocara infection, but also to prevent acquired ocular toxoplasmosis. there is no need, therefore, to stimulate the contraction of pathogenic bacteria or helminths to achieve a healthy gut microbiota and to reduce allergic conditions. recommendations based on the hygiene hypothesis should preferably be based on results from controlled studies to prevent unintentional negative effects. it is both humans and companion animals who experience negative effects of a changed human-companion animal bond. the education given by vets to their clients should therefore also focus on preventing these negative health and behavioral effects. for instance, by giving science-based advice on feeding practices. in general, regulating authorities should encourage the development of enforcement criteria for breeding dogs and cats to reduce health and welfare risks. pets undoubtedly have a positive effect on human health and well-being, while owners are increasingly aware of pet health, welfare, and well-being. anthropomorphism, also resulting in behavioral problems and breeding on appearance rather than health, and trends such as keeping exotic animals and importing rescue dogs may result in an increased risk of contracting zoonotic infections. recommendations regarding responsible pet ownership, including normal hygienic practices, responsible breeding, feeding, housing, and mental and physical challenges conform the biology of the animal, are key in preventing such negative aspects of the human-animal bond. there is no need to stimulate unhygienic practices following the hygiene hypothesis. education can be performed by vets and physicians as part of the one health concept. the brewing storm one health initiative. available online: www.onehealthinitiative.com 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pollution: a review. front. public health , , abridged version of the awmf guideline for the medical clinical diagnostics of indoor mould exposure house dust mite allergy under changing environments interactions between helminth parasites and allergy the impact of helminths on the response to immunization and on the incidence of infection and disease in childhood in uganda: design of a randomized, double-blind, placebo-controlled, factorial trial of deworming interventions delivered in pregnancy and early childhood immunologic profiles of persons recruited for a randomized, placebo-controlled clinical trial of hookworm infection an update on the use of helminths to treat crohn's and other autoimmune diseases infections presenting for clinical care in early life and later risk of hay fever in two uk birth cohorts this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the authors declare no conflict of interest. key: cord- -i ghp p authors: lindner, sonja; kubitschke, lutz; lionis, christos; anastasaki, marilena; kirchmayer, ursula; giacomini, simona; de luca, vincenzo; iaccarino, guido; illario, maddalena; maddalena, antonio; maritati, antonio; conforti, diego; roba, isabella; musian, daniele; cano, antonio; granell, monica; carriazo, ana m.; lama, carmen m.; rodríguez, susana; guligowska, agnieszka; kostka, tomasz; konijnendijk, annemieke; vitullo, maria; garcía-rudolph, alejandro; sánchez, javier solana; maggio, marcello; liotta, giuseppe; tziraki, chariklia; roller-wirnsberger, regina title: can integrated care help in meeting the challenges posed on our health care systems by covid- ? some preliminary lessons learned from the european vigour project date: - - journal: international journal of integrated care doi: . /ijic. sha: doc_id: cord_uid: i ghp p the covid- pandemic puts health and care systems under pressure globally. this current paper highlights challenges arising in the care for older and vulnerable populations in this context and reflects upon possible perspectives for different systems making use of nested integrated care approaches adapted during the work of the eu-funded project vigour (“evidence based guidance to scale-up integrated care in europe”, funded by the european union’s health programme – under grant agreement number ). from becoming infected while also getting the best care in this exceptional situation, also considering that the attribution of vulnerability may need to be redefined within this pandemic [ ] . in addition, how can care systems be equipped to continue providing complex care management in times of social isolation and containment? prior to the outbreak, care authorities from six european countries have joined forces in the vigour project funded under the rd european health programme in order to systematically review current practices in the health and care sector to see how existing services could be improved [ ] . taking current service delivery processes as point of departure, participating health care authorities had started to systematically analyse how current processes can be scaled-up to deliver better joined-up care. however, the pandemic has gradually reached all vigour countries since the beginning of this year. the aim of this perspective paper is to draw lessons from the vigour partners' covid- experience to date with regard to improving current practices by means of better integrating service delivery across health and social care. integration of health and social care is widely advocated as way to improve the management and outcomes for increasing numbers of older, vulnerable people with varying and/or complex health and social care needs [ , ] with the goal to improve quality of care, quality of life, patient satisfaction and efficiency of care provision [ ] . however, the implementation of structural changes in care delivery has often proved difficult in everyday practice [ , ] . one aspect adding complexity in this respect con-cerns the fact that integrated care represents a "nested" concept rather than a pre-defined organisational model of care delivery [ ] . in practice, integrated care is strongly context bound, can take different forms [ , ] and there is a strong processual element in its implementation, e.g. when it comes to enabling cooperation and coordination processes involving different parties across care settings [ , ] . such processes can take different forms depending on the given care contexts [ ] [ ] [ ] [ ] . against this background, a multi-staged process was developed by the vigour project [ ] to support participating stakeholders in identifying and implementing innovative practices with a view to better joining up hitherto separated care delivery processes (figure ) . each care authority can build on previous efforts to better align care delivery across the care chain, albeit in different ways and to different degrees. the vigour process therefore begins with a targeted consolidation of the integration ambition, which is to be pursued by each care authority throughout the project. this is followed by a systematic assessment of the desired integration approach with respect to its appropriateness and feasibility under given framework conditions. next, an operational implementation plan is developed as basis for piloting and evaluating the newly developed integration approach under day-today conditions with a view to preparing further upscaling. this process is further supported by means of knowledge transfer and mutual learning. the experiences gained during the pandemic so far reinforce the care integration approach of the vigour project and encourage to build more connected health and care systems enabling collaboration across care settings and disciplines [ , ] . effective responses to the covid- pandemic require quick, collaborative and large-scale reactions; however, the current fragmentation in health and care systems inhibits these requirements. maybe the present circumstances allow us to perceive the pandemic as a catalyst to redesign and integrate care pathways, also equipping us for any disruptive changes that may come beyond covid- [ ] . vigour care authorities detected features gaining a higher importance during the pandemic outbreak, evolving into three major requirements to drive innovation in integrated care under emergency situations within health and care systems. first, the increased need for technology related innovation with regard to covid- was recognized. major aspects that gained momentum were triage and (remote) pre-triage, tele-consulting and telemonitoring of covid- positive patients and suspected cases, employment of screening or mobile diagnostic applications, contact tracing and monitoring of hospital and icu beds availabilities. second, vigour pilot sites detected the requirement for quarantine related innovation during the pandemic outbreak. social isolation and quarantine are required to be managed by means of cross-service guidelines for home isolation, by fostering at-home physical activity during quarantine and keeping remote contact with lifestyle coaches. third, dynamics were also facilitated in the field of care pathway related innovation. a stronger involvement of case managers, personalized care planning efforts for covid- patients, the development of dedicated integrated care processes and clinical pathways for patients and suspected cases and an enhancement of advanced care planning in long-term care represent underlying mechanisms anticipated. figure illustrates the project approach and how preliminary experiences with covid- were incorporated into the process. reflecting upon the vigour progress so far, some preliminary lessons learned can be drawn on how envisaged care integration approaches of the pilot sites were shaped within the course of the pandemic. not surprisingly, ehealth and digitalization in their various characteristics represent a valuable tool for facilitating integrated care processes also during the covid- pandemic. the covid- experiences that the vigour partners have been able to make so far have made particularly clear the potential generally provided by digital technologies for the provision of person-centred and coordinated integrated care. however, the availability of practical and safe applications is crucial [ ] . this fact has also been highlighted recently in a report released by the international foundation of integrated care (ific) [ ] . still, it would be a false inverse conclusion to expect that digital technologies automatically lead to better care [ ] . indeed, usability and benefit of digital technologies in integrated care strongly depend on the context and needs of the target populations. social isolation was discovered as hotspot, as on the one hand, it has proven to be a necessity to avoid transmission of the covid- infection and on the other hand, isolation may lead to deeper psychological and mental health issues, especially for older, vulnerable citizens [ , ] . literature highlights that isolation or loneliness has a detrimental effect on health, with depression and cardiovascular health as outcomes most researched [ ] . the introduction of dedicated clinical pathways, integrated care process management for covid- patients and case managers are seen as reasonable healthcare practices by vigour partners helping to maintain healthcare capacities and guarantee integrated care provision in pandemic times. especially the employment of case managers and care coordinators helps to overcome fragmented healthcare organization. this fact is getting even more relevant when considering the still existing underrepresentation of case management and care coordination in integrated care for the management of an ageing population [ ] whereas integrating primary care with hospital care enables the establishment of a care continuum for patients [ ] . additionally, the role of primary health care in regards to the development of an integrated care system has received prompt attention by vigour partners and is on line with the world health organization (who) anniversary meeting in astana [ ] . the pandemic has brought to fragmentation and gaps in our social and health care systems and has accelerated the need for integration and coordination of health and social care. in order to achieve better integration, a realistic perspective is moving forward given the complexity and variety of culture and socio-political dependant variables. the framework within vigour project partners takes into consideration the fact "that one model does not fit all". thus, the insights and various models developed during the project will assist the exploration, development and implementation of different care integration approaches in distinct systems across europe [ ] as well as in times of the pandemic and beyond [ ] . the onset of covid- constitutes a critical issue and forces health care systems not to just provide acute care opportunities for covid- patients, but also to rethink and redesign care pathways. the vigour project approach seems robust to influences evoked by the pandemic and flexible enough to take advantage of integrated care initiatives available on pilot level and adopt them to specific needs emerging in pandemic times. ehealth, quarantine management and integrated clinical management of covid- patients and suspected cases evolved into promising aspects, leading health and social care systems towards a more integrated care approach. further information on this topic may be expected from vigour by fall . reconfiguring health systems vital to tackling covid- world health organization. q&a on coronaviruses (covid- ) redefining vulnerability in the era of covid- . the lancet world report on ageing and health. geneva: world health organization organizing integrated health-care services to meet older people's needs. bulletin of the world health organization clinical and service integration. the route to improved outcomes. london: the king's fund handbook integrated care unterstanding change in complex health systems -a review of the literature on change management in health and social care frameworks of integrated care for the elderly: a systematic review a report to the department of health and the nhs future forum. integrated care for patients and populations: improving outcomes by working together. london: the king's fund & nuffield trust providing integrated care for older people with complex needs. lessons from seven international case studies. london: the king's fund what is integrated care? an overview of integrated care in the nhs. london: nuffield trust framework on integrated, people-centred health services. geneva: world health organization learning from seven leading localities. london: local government association vigour. the vigour scaling-up approach realising the true value of integrated care: beyond covid- out now: second vigour newsletter digital technologies supporting person-centered integrated care -a perspective digital technologies as a catalyst for change towards integrated care delivery: hype or reality? a second pandemic: mental health spillover from the novel coronavirus (covid- ) the outbreak of covid- coronavirus and its impact on global mental health social isolation, loneliness and health in old age: a scoping review world health organization. technical series on primary health care. integrating health services. geneva: world health organization a vision for primary health care in the st century. towards universal health coverage and the sustainable development goals. geneva: world health organization and the united nations children's fund creating a culture of health in planning and implementing innovative strategies addressing non-communicable chronic diseases authors acknowledge the continuous support and contribution of partners of the eu-funded vigour project (grant agreement number ). the authors have no competing interests to declare. key: cord- -yvgvyif authors: french, jeff; deshpande, sameer; evans, william; obregon, rafael title: key guidelines in developing a pre-emptive covid- vaccination uptake promotion strategy date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: yvgvyif this paper makes the case for immediate planning for a covid- vaccination uptake strategy in advance of vaccine availability for two reasons: first, the need to build a consensus about the order in which groups of the population will get access to the vaccine; second, to reduce any fear and concerns that exist in relation to vaccination and to create demand for vaccines. a key part of this strategy is to counter the anti-vaccination movement that is already promoting hesitancy and resistance. since the beginning of the covid- pandemic there has been a tsunami of misinformation and conspiracy theories that have the potential to reduce vaccine uptake. to make matters worse, sections of populations in many countries display low trust in governments and official information about the pandemic and how the officials are tackling it. this paper aims to set out in short form critical guidelines that governments and regional bodies should take to enhance the impact of a covid- vaccination strategy. we base our recommendations on a review of existing best practice guidance. this paper aims to assist those responsible for promoting covid- vaccine uptake to digest the mass of guidance that exists and formulate an effective locally relevant strategy. a summary of key guidelines is presented based on best practice guidance. as we work to develop a range of safe and effective covid- vaccinations, the anti-vaccination movement has already fired the first shots in what will be a global public health battle. research shows that general vaccine hesitancy (i.e., 'the delay in acceptance or refusal of vaccines despite the availability of vaccination services') is rising for several diseases, resulting in serious disease outbreaks. for example, european countries experienced more than cases of measles in [ ] . vaccine hesitancy has also steadily increased in more than % of countries since [ ] . given the potential to undermine vaccination coverage, all states must take steps to understand the extent and nature of hesitancy and to start promoting covid- vaccine uptake. as the who recommends, 'each country should develop a strategy to increase acceptance and demand for vaccination' [ ] . each country must consider the appropriate time to start promoting the uptake of covid- vaccines based on its specific trajectory of covid- infection and its ability to provide access to vaccination. as covid- vaccination uptake develops, governments should continue to promote other protective behaviors such as handwashing and physical distancing. this paper aims to set guidelines that governments and regional bodies across the world should take to enhance the impact of their pro-vaccination strategy. we base our summary on recommended best practice with the aim of assisting professionals to digest the mass of guidance that exists in the hope that the summary contained will inform the guidelines needed to maximize uptake of covid- vaccines. it is imperative that planning for a covid- vaccination uptake strategy begins in advance of vaccine availability for two reasons. first, countries will need to determine population sub-groups and build a consensus about the order in which these will get access to the vaccine. second, we should reduce fear and concern and create demand for vaccines. a key part of this strategy is to counter the anti-vaccination movement that is already promoting hesitancy and resistance. since the beginning of the covid- pandemic, we have witnessed a tsunami of misinformation and conspiracy theories that have the potential to reduce vaccine uptake. to make matters worse, sections of populations in many countries display low trust in governments, official information about the pandemic, and the official approach in tackling the epidemic. the who advocates a pre-emptive pro-vaccination strategy that psychologically inoculates the population and maximizes uptake of vaccines as they become available [ ] . this paper sets out the core elements of such a strategy. the paper explores key issues that relevant organizations must address and summarizes best practices that should be addressed when developing behavioral influence strategies to promote the uptake of covid- vaccines effectively, efficiently, and ethically as they become available. this paper does not set out a full review or commentary on the thousands of scientific papers and national and international guidance documents that already exist with respect to promoting vaccine uptake and reducing vaccine hesitancy. the volume and dispersed nature of this literature is, in some ways, an impediment to action as few people will have a full grasp of the multiple fields of research that inform it. the paper also does not attempt to set out a full planning model or a 'how-to' guide, as numerous well-tested examples already exist [ ] [ ] [ ] [ ] . the paper does not provide a comprehensive set of references; instead, it cites select evidence summaries and guidance documents to aid further reading. finally, we have not included a separate evaluation strategy, as each of the key guidelines will need an integrated monitoring and evaluation strategy to enable continuous improvement. context matters. each government and public health service face its own set of unique challenges. different countries also have differing resources, capacities, capabilities, assets, and constraints. regardless of such settings and challenges, governments and relevant bodies can action a number of key processes identified in the literature that will enhance vaccine uptake. we set out these key action areas in the guidelines below. see table . it is highly likely that in the coming months the who and other public health institutions will issue guidance about how to optimize the uptake of covid- vaccines. we present the guidelines set out in this paper as an ideal model based on the lessons learned from successful intervention programs to inform such guidance. organizations, however, should approach each action area in a locally relevant way. it is also clearly a big ask to address all the recommended guidelines identified, but the more of these actions that can be applied, the more likely it is that a successful uptake strategy will be delivered. it is important that a systematic approach to planning is adopted. there are numerous planning models from the fields of health promotion and social marketing that authorities can use to define objectives, design processes, and conduct monitoring and evaluation of efforts to promote vaccine uptake [ ] . the most crucial action is to set out a transparent (open access) and a logical plan that covers all the essential components contained in the guidelines included in this paper. however, a coordinated and a systematic approach will require strong leadership. behaviour change plans should also be informed by lessons from the fields of management, logistics, and emergency and disaster planning such as the highlight, audience, behaviour, intervention, test (habit) behaviour disaster change planning framework [ , ] . authorities should also consider lessons and tips set out in several detailed planning models and guides developed specifically for vaccine promotion efforts such as: who. guide to tailoring immunization programs (tip) for infant and child vaccination [ ] . the tip principles apply to communicable, non-communicable, and emergency planning where behavioral decisions influence outcomes [ ] https://www.who.int/immunization/programmes_ systems/global_tip_overview_july .pdf?ua= european centre for disease control (ecdc). technical guide to social marketing https://www.ecdc.europa.eu/en/publications-data/social-marketing-guide-public-healthprogramme-managers-and-practitioners who. improving vaccination demand and addressing hesitancy. https://www.who.int/ immunization/programmes_systems/vaccine_hesitancy/en/ ecom: effective communication in outbreak management (ecom) [ ] . the e.u. funded ecom project brings together multiple disciplines to develop an evidence-based behavioral and communication package for health professionals and agencies throughout europe in case of significant outbreaks of infectious diseases. http://ecomeu.info/ tell me. review of population behavior and communication during pandemics: https://www. tellmeproject.eu/ human center design for health. a comprehensive set of tools developed by unicef to apply the human-centered design approach to challenges facing health services, with a particular emphasis on demand for immunization and health services. https://www.hcd health.org/resources social science research for vaccine deployment in epidemic outbreaks. a practical guide to using social science research and insights to better understand social, behavioral, cultural, community and political dynamics as part of efforts to introduce vaccines in epidemic outbreak settings. https://opendocs.ids.ac.uk/opendocs/bitstream/handle/ . . / / pracapproach% .pdf?sequence= &isallowed=y further generic planning guidance can be found at: building better health: a handbook for behavioral change. "the handbook blends proven disease prevention practices and behavioral science principles into a one-of-a-kind, hands-on manual." [ ] (p. xiii). cdcynergy planning tool for social marketing. centers for disease control and prevention planning tool for social marketing, atlanta, ga. also available is cdcynergy "lite", intended for those who have previous social marketing experience and those who are familiar with the full cdcynergy edition. https://www.thecommunityguide.org/resources/cdcynergy applying behavioral insights-simple ways to improve health outcomes. a tool for the application of behavioral insights to improving health outcomes from the world innovation summit for health. https://www.imperial.ac.uk/media/imperial-college/institute-of-global-health-innovation/ behavioral_insights_report-( ).pdf if governments develop vaccine uptake programs based only on expert opinion, they are likely to be suboptimal [ , ] . what is required is an approach that seeks to gather as much understanding as possible about what people say will prevent, encourage, and assist them in taking up vaccines. authorities must understand what people value and what they fear when developing an effective promotional program. a targeted approach that uses a different intervention mix for different subsets of the population will be more effective. people do not respond uniformly to preventive interventions. for example, being older, female, and more educated is associated with a higher likelihood of adopting protective behaviors [ , ] . 'insight' data about citizens' attitudes, beliefs, wants, and behaviors should inform interventions. insights are 'deep truths' and understanding about why people act as they do. such insights can be developed from formative qualitative and quantitative survey research, observational data, demographic data, service use data, problem or issue tracking data, and epidemiological data. the development of deep insights into people's lives, with a focus on what will or will not motivate or enable people to take up vaccination, is a crucial investment that must be made to inform all aspects of vaccination promotion uptake strategy. a key component of behavioral planning is the setting of measurable behavioral objectives that are relevant and timely in relation to maximizing vaccine uptake. setting measurable goals related to uptake, attitudes, intention, understanding and beliefs will help focus behavioral planning and enable meaningful ongoing tracking and evaluation of impact [ ] . segmentation is key to success. segmentation is the identification of groups who share similar beliefs, attitudes and behavioral patterns. segmentation goes beyond demographic, epidemiological, and service uptake-based targeting. segmentation includes data about people's attitudes, values, understanding and observed behaviors. population segmentation models enable public heath planners to tailor interventions to specific audiences [ ] . fournet et al. have identified four unprotected and under-protected population groups that could form the basis for the development of a locally developed strategy [ ] : • 'the hesitant'-those who have concerns about perceived safety issues and are unsure about needs, procedures and timings for immunizing. • 'the unconcerned'-those who consider immunization a low priority and see no real perceived risk of vaccine-preventable diseases. • 'the poorly reached'-those who have limited or difficult access to services, related to social exclusion, poverty and, in the case of more integrated and affluent populations, factors related to convenience. • 'the active resisters'-those for whom personal, cultural, or religious beliefs discourage them from vaccinating. other segments that need dedicated foci are health and social care workers. studies have revealed that certain healthcare workers hesitate to vaccinate themselves or their family members [ , ] . the ecdc provides guides and toolkits for healthcare workers, immunization program managers, and public health experts, to support their efforts in addressing vaccine hesitancy [ ] . frontline workers can be a significant source of trusted advice and information but are often not optimally used in such roles. these workers lack training and support in advocacy roles and may also lack a full awareness of risks and safety issues associated with the disease and vaccination. governments and responsible agencies should facilitate support structures that increase worker awareness and willingness to act as public health advocates. to effectively promote and maintain demand for a covid- vaccine, governments and regional bodies must develop an insight-informed pro-vaccination strategy that includes action to reduce the impact of four kinds of competition: • active competition from the ani-vaccination movement • passive competition in the form of inaccurate media coverage • competition from negative social norms • competition in the form of structural and economic factors effective campaigning against vaccine misinformation should focus on the dangers of the disease as well as on the benefits of the vaccines, which can include highlighting protection. such approaches draw on the powerful motivator of fear of loss along with the possibility of gain of positive health [ ] . intervention designers should involve the target populations in building campaigns, and use data-supported insights about what will and what will not motivate them to take up vaccine programs and about how to frame the promotion of vaccination. a competition strategy that seeks to reduce the impact of those promoting hesitancy that emphasizes fact-checking and myth-busting may do more harm than good. such approaches often repeat misinformation as part of rebuttal strategies. engaging directly with conspiracies often spreads rather than closes down such views. people often exhibit what lord calls confirmation bias; they look and accept information that fits with their existing views and reject information that runs counter to their existing views [ ] . so, when repeating misinformation in order to debunk it, people may just hear the misinformation. a more effective approach is a combination of positive messaging that emphasizes the protective (individual, family, and community) benefits of the vaccine and the loss associated with not being vaccinated (death, poor health, loss of freedom and social solidarity, inability to travel, etc.) [ , ] . anti-vaccination advocates should not be left free to spread misinformation. public health authorities and their coalition partners, including both the traditional and digital media sectors, should proactively work together to reduce and remove at speed false content and misleading information. traditional media providers should be supported and briefed so that they are aware of anti-vaccination propaganda identified by public health authorities and do not repeat it. traditional media and social media sectors should also provide authorities with the information they have detected that anti-vaccination advocates are propagating so that information can be rebutted. public health agencies should seek protocols with media providers about the issue of how journalistic balance will be addressed. agreements should be put in place about how the media will identify and flag false and misleading anti-vaccination information and advocates. in this regard authorities and media channel providers should be alert to 'astroturfing' (anti-vaccination advocates disguising their views as coming from grass roots movements) and act swiftly to expose such tactics. finally, agreements should be developed about how and when misleading information and advocates of such information should be removed and flagged as being problematic on social media. distrust in elites and experts and political populism can also fuel antivaccination sentiment [ ] . social norms and cultural influences can have a significant effect on people's willingness at the population level to take up vaccine programs [ ] . as an initial step, authorities need to understand what informs social norms and beliefs. persuasive efforts should appeal to the values and beliefs that people already hold, such as a desire to protect family members, rather than a focus on factual or probabilistic messaging. validating people's existing motivations and using them to encourage behaviour is more effective than trying to shift people's world view. if, however, people hold incorrect opinions about the social norms prevailing in their community, for example, the erroneous belief that most people oppose vaccination, it can be helpful to inform them that a high percentage of people do in fact, support vaccination. subjective social norms, i.e., those that are informed by what we think key others in our social circles believe, are also crucial in promoting vaccine uptake [ , , ] . opinion leaders in the anti-vaccination community may hold negative attitudes and beliefs, so intervention organizers should also develop interventions with such key informants to address these concerns and seek to turn such informants into advocates for vaccination. previous reviews of vaccine demand campaigns using a systematic process, such as in the area of human papilloma virus (hpv) vaccine, have found that myths and misinformation, often prevalent in communities, can also pose significant barriers to vaccine adoption. evans et al. studied several hpv and cervical cancer awareness studies in low-and middle-income countries (lmics) [ ] . these studies confirm many widely reported barriers to hpv vaccination; these include myths (e.g., the vaccine causes infertility), beliefs that it will increase promiscuity, negative social norms within social groups, and concerns about safety and efficacy. solutions to these barriers include: • increasing knowledge about the risks prevented by the vaccine. promoting understanding that the community of interest is at risk; improving beliefs in vaccine safety, effectiveness, and community benefit. • dispelling unfounded myths. building a social norm that vaccination uptake is widespread and accepted in society (descriptive and injunctive normative beliefs). vaccine uptake strategy must address difficulties in accessing vaccines due to cost, lack of transportation to vaccination sites or clinics, and/ or a lack of a cold-chain network. authorities need to work with partners across government, ngos, communities, and the for-profit sector to reduce these barriers. poor access can reduce confidence in and demand for the vaccine. vaccine uptake promotion should thus facilitate availability and convenience. it is vital that countries review their public health finances early on to allocate funds to vaccinate their populations, as many countries already carry large debts. to inoculate the entire global community will require significant resources. countries with lower incomes will need to develop plans to access support from the international aid programs provided by governments, u.n. bodies and foundations, and other sources to secure adequate supplies of vaccines. promoters of the covid- vaccine should also consider that their efforts do not negatively impact on the availability and the uptake of other vaccine programs, predominantly for children. public health organizations rarely have sufficient resource capacity to develop, deliver, and maintain population-level change-focused programs. building and sustaining coalitions of organizations and individuals who can assist through the provision of resources, expertise, credibility and access is a crucial early action that needs to be addressed. critical asset identification and management falls into three main categories: government capacity coordination, private sector and ngo sector mobilization, and the mobilization of civil society. building alliances within government and across departments is a crucial aspect of asset identification and mobilization [ ] . there is a need to develop plans and structures to coordinate action between government agencies and departments and organizations such as hospitals, clinics and schools [ ] . an alliance or coalition team should also coordinate mechanisms and resources and set out chains of command and responsibilities. the ngo and private sectors can play a pivotal role in promoting the uptake of vaccines. partnerships with the pharmaceutical industry to develop, manufacture, promote, and distribute vaccines are underway across the world. many other for-profit organizations can also be harnessed to provide logistical and promotional support. the ngo sector is also well placed in terms of its reach, high level of understanding about local communities, and high levels of trust to act as a critical advocate and network for vaccine uptake. the third leg of the asset and capability resource base is civil society, represented by community groups and associations such as religious groups, community associations, recreational groups and community charities and volunteers. these groups and communities can play a crucial role in encouraging vaccine uptake and assisting with distribution and access. however, the part that civic society can play in promoting and helping with vaccine uptake is highly country-specific; therefore, local plans will need to reflect the role that such groups can play [ ] [ ] [ ] . developing and maintaining a vaccine promotion coalition of government, the private sector, the ngo sector, and civic society requires resources and staff with expertise in creating and managing stakeholder relationships. authorities need to identify the resources needed to undertake these essential tasks, set objectives, monitor progress, and provide feedback. well planned, evidence-based, and theory-informed health communication and health marketing can significantly impact behavior and vaccine uptake [ , , ] . well-designed campaigns, together with the application of behavioral science techniques, need to be supported by ease of access to vaccines, distribution networks and logistics, and taking notice of broader socio-economic and cultural factors [ , ] . those responsible for creating demand for the vaccine need to work with vaccine suppliers, administrators, and those delivering vaccination to bring together a full mix of demand-side and supply-side interventions. the intervention mix needs to include coordinated action in the fields of prioritization and access policy, supply systems, and promotions strategy. prioritization is especially critical, given insufficient availability, especially after the initial months of vaccine launch. more important than building general demand are building awareness and support for covid- vaccination prioritization plans and fostering high acceptance among people in priority groups. the key to promoting demand is a deep understanding of what will enable and encourage uptake. campaign managers should conduct formative research including secondary research based on published literature and case studies and primary research with interviews and surveys in each population to gain audience-specific insights. governments will need to deliver and communicate what mix of incentives and penalty interventions will be used to promote demand [ ] . demand strategy will also need to be supported by the development of a compelling, insight informed and segmented promotion that speaks to people's needs, values, and wants. health communicators must develop narratives that emphasize the positive personal, family, and community benefits associated with vaccine uptake. the demand strategy will need to include guidelines that reduce the influence of anti-vaccination advocates (see sections below for critical steps to consider when developing a competitor strategy). the demand strategy must also utilize positive narratives in both traditional and social media and apply behavioral influence tactics informed by behavioral sciences [ , ] . the who recommends that every country should include ongoing community engagement and trust-building programs. programs should be focused on confidence-building and active hesitancy prevention, together with regular national assessments of population concern and trust [ , [ ] [ ] [ ] . trust is built and maintained through transparency, constancy, active listening programs, and encouraging dialogue. agencies and governments need to share knowledge about certainty and uncertainty. governments and public health agencies also need to pre-empt and address any safety issues that are expressed or felt by the public or media [ ] . governments should also be transparent about vaccine licensing, manufacture, and prioritization planning. consistency of both messaging and policy directives is also crucial. the absence of these conditions will trigger confusion and reduce trust [ ] . anti-vaccination attitudes do not always relate to factors like level of education [ ] . instead, they are often related to anger and suspicion towards elites and experts and increasing support for anti-establishment political concerns. governments should listen actively and build dialogue, encouraging continuous feedback from citizens, key commentators, and influencers. regular proactive public media and influencer briefings should also form a central plank of trust-building strategy. the application of citizen-focused and human-centered design principles can also enhance program development and implementation [ ] . relevant agencies should realize the need for a coordinated mix of interventions to promote vaccine access, led by a strong leadership team [ ] . promoting uptake through the media and community advocates is a critical element of any pro-vaccination strategy, but it is not a panacea for convincing everyone reluctant to vaccinate. research shows that behavioral change is a complex process that entails more than having adequate knowledge about an issue. uptake and hesitancy are also related to cultural factors, attitudes, motivations and experiences, social norms, and structural barriers. understanding the multiple factors involved in people's decisions is, therefore, key to success. governments and public health authorities can enhance the effectiveness of their efforts by combining multiple strategies [ ] . for example, they could integrate financial and non-financial incentives, call and reminder interventions, along with penalties for non-compliance by imposing restrictions on travel, education, or employment [ ] . vaccine access information, requirements and support will need to reflect each country's vaccination implementation strategy. will it be mandatory? will there be penalties for non-compliance? communicators should deliver implementation and access strategies through a segmented approach that provides specific and relatable information to identified subgroups of the population about how and when they can have access to vaccination. call mechanisms will need to be established and monitored as part of this element of the strategy. with regard to vaccine selection, assuming that the medical fraternity has developed several safe and effective vaccines by , governments and public health authorities will need to explain to the population why they selected a particular vaccine in terms of its efficacy, safety, cost, etc. authorities will also need to explain their reasoning for the prioritization model for the vaccination that they adopt. for example, if a risk-based approach is adopted in which older people and care workers are prioritized over younger people and non-essential workers, this needs to be explained. governments and regional bodies need to explain and justify these decisions in terms of health protection, social and economic imperatives, safety and cost imperatives. schedules and timetables for total population vaccination should also be developed and shared before vaccination roll out begins so that everyone understands when they will get access. ideally authorities should share their plans for vaccine roll out prior to availability so that there is time for ethical and procedural issues to be publicly debated and a consensus reached. a coordinated national approach to communication will be successful among many groups, but not all [ ] . success depends on the nature and degree of immunization hesitancy and the degree of segmentation. tailored messages focusing on known motivators for specific groups are more likely to produce a desired behavioral response than a 'one size fits all' approach [ ] [ ] [ ] . to produce tailored messages, we recommend quantitative and qualitative formative research and ascertaining the efficacy of strategies with pre-test research before launch. as stated previously, there is a need to set out a compelling narrative that avoids 'backfire effects' [ ] , validates people's concerns, and addresses both fear of loss and the positive gain that will accrue from vaccine uptake. as tversky and kahneman have demonstrated, when confronted with choices we are averse to any that might result in perceived loss [ ] . we also do not like being confronted with complex choices. it follows that, if governments want to influence people to take up vaccination, they are more likely to be successful if the strategy emphasizes the positive gains accrued from vaccination, the loss that will occur if vaccination is refused, and that access to vaccines is easy. we know that the perceived attractiveness of options varies when communicators frame the same choice differently. therefore, the language used, the imagery, the messengers, and audio-visual effects are all important considerations that communicators should pilot test. as stated previously, authorities should tailor their promotional strategies by subgroups of the population, as each segment will respond differently to varied messaging and narratives. familiarity and trust in the messenger, as well as the message, is also a crucial success feature in tackling vaccine hesitancy [ , ] . authorities should determine which campaign face and voice should be used based on formative research with the target audience. messages that come from a variety of trusted sources are likely to make a vaccine promotion programs more successful. spokespeople recruited from trusted groups, including healthcare professionals and relatable members of the public, can enhance the effectiveness of campaigns. high-profile personalities can also be effective in communicating messages, as they lend their prestige and trust to the health communication activity. the use of religious leaders (like the cooperation offered by muslim religious leaders in india to communicate the importance of polio vaccination), community influencers and third-party advocates, such as teachers, can also improve support for vaccination uptake [ ] . as part of long-term public health strategy, governments and public health agencies should enhance media and digital literacy in schools and community settings, specifically related to health and vaccine topics [ ] . newly acquired literacy will equip the public to identify reliable sources of information and encourage reporting of misinformation to social media providers and regulating authorities. the news and general media can contribute significantly to address fears and risk perceptions, which can hurt vaccine uptake [ ] . it is, therefore, necessary to develop a proactive strategy for working with traditional media. any media management and engagement strategy that is developed will need to include proactive, rolling media briefings, story generation, editorial feeds, facilitating access to medical and other clinical and public health experts, advisers, and data. the media management and engagement strategy will also need to include / media monitoring and rebuttal/correction systems. communicators should mediate ongoing relationships between media contacts and experts who can provide accurate opinions on all aspects of vaccine promotion and safety. authorities should additionally monitor the strength of this relationship and address rapidly any conflicts that may arise. the responsibility of government agencies and others advocating for covid- vaccination is to communicate better, more visible, and more highly credible messages than the sceptics. successful media engagement is more likely when the public health system has developed a strong collaborative and open relationship with key editors, sub-editors and journalists. public health authorities and governments should continuously nurture trust and positive working relationships with media organizations so that the audience views the former as accessible and trustworthy. this will, however, require government authorities to be transparent, honest, and open regarding vaccine safety and effectiveness data that could be, or is, worrisome. anti-vaccination advocates abound on facebook, twitter, whatsapp, and youtube. social media platforms are already buzzing with misinformation about covid- vaccine safety, development, and planned rollout, months before vaccines are ready to be used at population level. it is encouraging to see such media platform owners starting to act against the anti-vaccination movement. for example, instagram avoids health misinformation in its explore page; youtube has demonetized anti-vaccination videos and gofundme has recently taken down anti-vaccination fundraising appeals. governments and their public health agencies need to develop a dialogue and joint strategy with social media platform providers to review and action against anti-vaccination misinformation and vaccine hesitancy promotion. governments and regional bodies should convince or regulate platform providers to remove misinformation. public health authorities need to build a proactive covid- vaccine trust capacity for active engagement in the social media space as part of their overall promotional strategy [ ] . social media platforms are now the primary information source and communication channel for a large and growing number of citizens. public health agencies need to invest in building teams of specialist staff trained and capable of understanding how to build and maintain social media presence. the key responsibilities of public health staff focused on social media are the development of and support for continuous positive story streams, nurturing multiple supportive voices, and amplification of pro-vaccination grassroots advocates. these dedicated staff need to support pro-vaccine influencers, advocates and social networks. public health staff can also assist in the identification of and responses to false social media posts. the team should address such negative posts instantly to prevent the decline of trust in public health authorities. we know, for example, that parents who are resistant to getting their children vaccinated are more likely to have based their decision on information obtained on the internet [ ] . the strategic and tactical guidance set out above provides a framework for promoting the uptake of covid- vaccines as they become available. this paper also acknowledges the importance of evidence and theory-driven behaviour change tools in addressing vaccine hesitancy. this is consistent with who's recent establishment of the technical advisory group on behavioral insights and sciences for health [ ] . key to the success of promoting vaccine uptake will be a significant and sustained strategic program, including strengthening of local capacities, to build and maintain confidence and trust [ ] . a crucial factor in the delivery of such a trust-building and demand building approach is the need for investment in communication, behavioral influence, and community engagement capacity and capability. communication and behavioral influence are often underfunded or under-resourced in public health organizations and within government ministries. building communication and behavioral influence capacity and expertise should be a priority. it is now often said that everything will be different in the post covid world; hopefully one difference will be a commitment to investment in developing and delivering the key action elements set out in this paper. this investment will need to be sustained over time in line with best practice requirements regarding risk communication and community engagement so that we are better prepared for inevitable future events [ ] . the authors acknowledge that countries, high-, low-and middle-income, have been using many of the guidelines described in this manuscript to foster high vaccination coverage. the challenges are not that they are unaware of the actions described here but rather: ( ) they have very limited resources (e.g., money, people) to implement all the actions at the scale the authors are recommending; and ( ) they are responsible for promoting and achieving compliance with vaccination schedules, not just a single vaccine. governments and relevant bodies should bear these limitations in mind as they consider our guidelines. world health organization. the guide to tailoring immunization programs; world health organisation vaccine hesitancy around the globe: analysis of three years of who/unicef joint reporting form data- - executive agency for health and consumers. project malmanagement in public health in europe a literature review on effective 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office of information. communications and behaviour change when corrections fail: the persistence of political misperceptions rational choice and the framing of decisions methods to overcome vaccine hesitancy social marketing in india health literacy and vaccination: a systematic review making a drama out of a crisis. a multidisciplinary study of news media coverage of a public health crisis and the role of emotion using social media to create engagement: a social marketing review a postmodern pandora's box: anti-vaccination misinformation on the internet technical advisory group on behavioural insights and sciences for health by failing to prepare, you are preparing to fail: lessons from the h n 'swine flu' pandemic this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license acknowledgments: not applicable. the authors declare no conflict of interest. key: cord- -z vhxg authors: gardiner, fergus w.; de graaff, barbara; bishop, lara; campbell, julie a; mealing, susan; coleman, mathew title: mental health crises in rural and remote australia: an assessment of direct medical costs of air medical retrievals and the implications for the societal burden date: - - journal: air med j doi: . /j.amj. . . sha: doc_id: cord_uid: z vhxg objective: adequate mental health service provision in rural and remote australian communities is problematic because of the tyranny of distance. the royal flying doctor service provides air medical retrieval for people in rural and remote areas. the economic impact on both the royal flying doctor service and the public hospital system for mental health–related air medical retrievals is unknown. we aimed to estimate the direct medical costs associated with air medical retrievals and subsequent hospitalizations for mental and behavioral disorders for the calendar year. methods: all patients with a primary working diagnosis of international statistical classification of diseases and related health problems, th version, australian modification f to f (mental and behavioral disorders) who underwent an air medical retrieval were included in this cost analysis. international statistical classification of diseases and related health problems, th edition, australian modification codes were mapped to australian refined diagnosis related group codes, with hospital costs applied from the national hospital cost data collection ( / ). all costs are reported in australian dollars (auds). results: one hundred twenty-two primary evacuations and interhospital transfers occurred with an in-flight diagnosis of f to f , most commonly psychotic disorders, including schizophrenia and schizotypal disorders. the total direct medical costs were estimated to be aud $ , , . costs for primary evacuations accounted for % (aud $ , , ), with the majority of this associated with the subsequent hospital admission (aud $ , , ). similarly, the majority of the costs associated with interhospital transfers (total costs = aud $ , , ) were also related to hospital costs (aud $ , , ). conclusion: direct medical costs associated with air medical retrievals for people experiencing a mental health crisis are substantial. the majority of costs are associated with hospital admission and treatment; however, the indirect (loss of productivity) and intangible (quality of life) costs are likely to be far greater. demonstrated by suicide rates, which increase in line with the degree of remoteness, ranging from . per , persons in major cities to . per , in very remote settings. although the drivers of this unbalanced burden of mental health conditions are many and complex, of the key factors is the supply of mental health services. the majority of mental health professionals, measured as full-time equivalent (fte) per , population, are located in major cities. specifically, . fte psychiatrists per , persons are based in major cities compared with . per , in outer-regional settings, . per , in remote settings, and . per , in very remote areas of australia. similar trends are observed for mental health nurses ( . fte nurses/ , persons in major cities, . / , in remote setting, and . / , in very remote settings) and clinical psychologists ( . / , in major cities, . / , in remote settings, and . / , in very remote settings). in addition to these supply-side issues, demand for mental health services differs from that in major cities and many urban centers. although the overall prevalence of mental health conditions is similar across settings, people in rural and remote settings experience higher rates of substance use and acuity of mental health conditions along with the aforementioned rates of suicide. , furthermore, increased environmental challenges including drought, fires, and climate change, and the recent coronavirus pandemic, are placing greater pressure on the mental health of many rural and remote communities. [ ] [ ] [ ] [ ] in this context, the royal flying doctor service (rfds) provides air medical retrievals for australians living in rural and remote communities experiencing health crises, including acute mental health presentations. patients are typically transferred by aircraft to large metropolitan or inner regional public hospitals for urgent acute care. the economic costs of this approach, including those incurred by the rfds and public hospitals, has not been quantified. the primary aim of this article is to determine the annual air medical retrieval and in-patient hospital-direct medical costs associated with mental and behavioral disorders from a health payer perspective. a secondary aim includes determining the mismatch of the supply and the capacity of rural and remotely located mental health services with the demand of acute presentations, with retrieval signaling as a potential proxy for this unmet need. the rfds provides air medical, road ambulance, and primary health care to rural and remote areas of australia without traditional medical services, such as those associated with the medicare benefits schedule, a listing of the medicare services subsidized by the australian government. the focus of this article is on air medical retrievals for mental health crises from a health care payer perspective. , design and participants a partial economic evaluation was undertaken using routinely collected air medical data for patients diagnosed in flight with a mental and behavioral disorder (international statistical classification of diseases and related health problems, th edition, australian modification [icd- am], chapter v) between january , , and december , . participants included all rfds patients who underwent an air medical retrieval, including a primary evacuation and interhospital transfer, for mental and behavioral disorders within australia in . the majority of the rfds air medical retrievals are conducted in western australia, central australia, queensland, and new south wales, with limited air medical retrievals coming from tasmania and victoria. tasmania and victoria air medical services are mainly conducted by other services; however, the rfds in / conducted substantial road transportation in victoria and tasmania (n = , ). for the primary aim, data were collected and coded on each patient's in-flight working diagnosis using the icd- -am coding method. the in-flight primary working diagnosis was based on referral assessment information and an assessment of the current medical status by the in-flight medical team, which, in this patient group, mainly consisted of a senior medical officer and/or a senior flight nurse. the in-flight primary working diagnosis was then coded by trained administrative staff and cross-checked by of the authors (l.b. and f.g.). data were collected within flight on the patient's sex, age, and indigenous status. both paper-based and electronic methods were used in data collection. detailed patient histories were not routinely collected. all air medical retrieval patients with a primary working diagnosis of icd- -am chapter v codes f -f (mental and behavioral disorders) were included in the analysis. all other diagnoses were excluded from analysis. we defined separate types of air medical retrievals: ) primary evacuations of a patient and ) interhospital transfers that involve an rfds air medical evacuation from, typically, a small regional hospital to an inner regional or major city hospital. to determine the economic costs per primary evacuation, we collected the costs incurred by each rfds section and operation (loosely state based), including the queensland section, western operations, south eastern section, and central operations. this included determining the individual primary evacuation costs by rfds base from each section and operation. to protect patient and rfds base confidentiality (particularly for those bases conducting a small number of retrievals), these costs were then averaged. costs included engine hour and staffing by an rfds registered nurse (present on all flights) and rfds medical officer as required. the costs for interhospital transfers were based on $ , per engine hour, which includes an rfds registered nurse. for transfers in which an rfds medical officer was also required, an additional $ , per hour was added to the cost of each interhospital transfer. this formula is consistent with other published literature. to estimate inpatient admission costs, we mapped the icd- -am codes to australian refined diagnosis related group (ar-drg) codes provided in the national hospital cost data collection ( / ) ( table ) . this mapping was performed by of the authors (b.d.g.) and independently checked by of the authors (f.g. and m.c.). it is important to note that although there are > , icd- -am codes and > , ar-drg codes, the national hospital cost data collection only contains codes. cost data were then extracted from the / national hospital cost data collection for each relevant ar-drg ( table ) . the costs were then applied to each primary evacuation and interhospital transfer, respectively. for interhospital transfers, the costs associated for the first admission (ie, the hospital from which the patient was transferred from) were not included because no icd- -am or ar-drg data are collected for this. the total aggregate costs were estimated for both primary evacuations and interhospital transfers. to further understand where costs are incurred, the disaggregated "cost buckets" reported in the national hospital cost data collection were assessed. these disaggregated costs include ward medical, ward nursing, nonclinical salaries, pathology, imaging, allied pharmacy, critical care, operating room, emergency department, ward supplies, specialist procedure suites, prostheses, oncosts (eg, indirect salary costs such as superannuation), hotel and depreciation (ie, domestic services within the hospital that are not directly related to patient care), and emergency department (ed) to determine the secondary aim, we used the rfds service planning and operational tool (spot) to map service provision throughout australia. spot uses data from the australian bureau of statistics and data from health direct to derive geographic population estimates reflective of mental health services. primary evacuation statistical areas were defined according to the australian bureau of statistics statistical area level code. spot has been designed to help determine the geographic coverage of health care in australia. spot graphically represents population concentrations and health care services and calculates the proportion of the australian population who are covered by specific health care facilities (in this case, general mental health services) within a -minute drive time. to map the location of air medical retrievals for diagnoses associated with mental health, we used tableau mapping software (tableau software, salesforce company, seattle, wa united states of america). this study used descriptive statistics to summarize findings. cost data were extracted from the / national hospital cost data collection for each ar-drg derived from the icd- -am mapping exercise. costs associated with rfds air medical retrievals were applied to each ar-drg. these costs were then summed and multiplied by the number of retrievals per ar-drg. expenditure based on cost buckets was extracted from the / national hospital cost data collection. each item in the cost bucket was multiplied by the number of air medical transfers with the corresponding ar-drg. costs for each cost bucket were summed for all ar-drgs, allowing for the calculation of the proportion of the total expenditure associated with each cost bucket. all costs are reported in australian dollars. analyses were conducted in excel (microsoft, redmond, wa). in addition, cell sizes with or less patients are supressed for confidentiality. this project was deemed a low-risk quality assurance project by the rfds clinical and health services research committee, which provides oversight for rfds research projects, on march , . because this project involved routinely collected data, specific patient consent forms were not required. over the calendar year, the rfds conducted primary evacuations and interhospital transfers for patients with an inflight diagnosis associated with a mental and behavioral disorder (icd- -am chapter v f -f ). all of the primary evacuations and interhospital transfers were from remote and very remote areas to inner regional or metropolitan centers (fig. a) . the primary evacuation statistical areas level included alice springs (northern territory) ( . %, n = ), the far north (northern queensland) ( . %, n = ), gold fields (western australia) ( . %, n = ), and the kimberly ( . %, n = ). figure b provides an illustration of the supply of mental health services derived from spot. when looking at the general mental health service coverage within these areas reflective of population concentrations, the gold fields ( . %, n = , ) had the highest remote and very remote population level without coverage followed by alice springs ( . %, n = , ), kimberly ( . %, n = , ), and the far north ( . %, n = , ). for primary evacuations, the leading diagnoses were for the f to f group of psychotic disorders, including schizophrenia, schizotypal, delusional disorders, and other non−mood-related psychotic disorders ( . %, n = ). schizophrenia ( . %, n = ), acute and transient psychotic disorders ( . %, n = ), and unspecified nonorganic psychosis ( . %, n = ) were the most common diagnoses. one similar to primary evacuations, the majority of interhospital transfers were associated with f to f , schizophrenia, schizotypal, delusional disorders, and other non−mood-related psychotic disorders ( . %, n = ). one fifth of the transfers were for f to f , mood (affective) disorders ( . %, n = ); . % (n = ) were for f to f , mental and behavioral disorders caused by psychoactive substance use; and . % (n = ) for f to f , organic, including symptomatic, mental disorders. small numbers of interhospital transfers were reported for f to f , disorders of adult personality and behavior ( . %, n = ); f to f , neurotic, stress-related, and somatoform disorders ( . %, n = ); f , unspecified mental disorders ( . %, n = ); and f to f , behavioral syndromes associated with physiological disturbances and physical factors ( . %, n = ). five or less evacuations were reported for f to f , behavioral and emotional disorders with onset usually occurring in childhood and adolescence; f to f , disorders of psychological development; and f to f , mental retardation. the total costs for all mental and behavioral disorder air medical retrievals and subsequent hospital admissions in was $ , , . the cost associated with the primary evacuations was estimated to be $ , , . two thirds of this ($ , , , . %) was related to in-patient admissions (ar-drg costs) and the remaining $ , on air retrieval costs. reflecting the numbers of patients, the highest combined air retrieval and in-patient costs were for u a (schizophrenia disorders, major complexity; $ , ), u a (paranoia and acute psychotic disorders, major complexity; $ , ), and u a (major affective disorders, major complexity; $ , ). the average cost per primary evacuation patient was $ , . the total cost related to interhospital transfers was $ , , . similar to primary evacuations, the majority of these costs were related to in-patient admission costs ($ , , ) . reflecting the numbers of interhospital transfers, the greatest total costs were associated with u a (schizophrenia disorders, major complexity; $ , , ), u a (paranoia and acute psychotic disorders, major complexity; $ , , ), and u a (major affective disorders, major complexity; $ , , ). the average cost per interhospital transfer patient was $ , (see table for cost breakdowns for primary evacutations and interhospital transfers). almost one third of all hospital costs (for both primary evacuations and interhospital transfers) were associated with the ward nursing cost bucket ( . %) (fig. ) . these costs are associated with nursing care provided in general wards. the ward medical cost bucket, which includes both salaries and wages for medical officers, accounted for . % of hospital costs. other notable cost buckets were . % for ward supplies (costs for medical and surgical supplies, ward and clinical department overheads, and goods and services), . % for nonclinical salaries (other costs of service provision, predominantly wages for carers such as patient care assistants), . % for oncosts (eg, superannuation, fringe benefits tax, long service leave, worker's compensation, and recruitment), and . % for ed product (ie, the average cost per admitted ed patient). this is the first study to quantify the direct medical costs associated with air medical retrievals of patients experiencing mental health crises in australian rural and remote settings. we estimated that the annual direct medical cost associated with this was $ , , for . most of these costs were attributable to hospital costs, with over % of this expended on ward nursing staff, medical staff, and ward supplies. importantly, this total cost represents a substantial underestimate of both the health payer and the societal impacts of these acute mental health events in the rural and remote areas of australia. more specifically, in regard to the direct medical costs, the costs of the first hospital (or retrieval site) admission for the patients who received an interhospital transfer were not included. furthermore, the substantial indirect costs associated with air medical retrievals have not been assessed. these costs include those associated with the lost productivity of patients, their families, and caregivers. in addition, intangible costs, largely the suffering associated with a condition that can be captured using quality of life instruments, is likely to be substantial from both a physical and, importantly, from a psychosocial perspective and has not been assessed in this study. for patients, particularly for those experiencing a first episode of psychosis, inpatient admission in addition to air medical retrieval and dislocation from usual social supports and networks can be a traumatic experience, with a recent systematic review reporting % of firstepisode psychosis patients experienced symptoms of post-traumatic stress disorder. although the impact of this experience is partially understood with patients, less is known regarding the impact and costs for families and caregivers. further research is required to fully understand the true costs, including indirect (loss of productivity) and intangible costs (quality of life), associated with air medical retrievals for mental health care and the current level of service provision to rural and remote communities in location. ultimately, the implications of these health payer and societal costs need to be understood in the context of considered funding and capacity considerations for rural and remote mental health services and providers. tough longer-term health care policy decisions are required by governments and health planners through the prism of the known economic costs for air medical retrievals, albeit as an underestimate of the likely true costs identified in this study. additional attention and research are required to qualify the grossly under-researched costs to rural and remote communities of retrieving patients with mental and behavioral disorders out of their communities from a societal impact perspective. the severe lack of psychiatrists, mental health nurses, psychologists, and social workers in rural and remote areas requires structural change to the supply of a qualified and competent rural and remote workforce. the recent australian senate inquiry into the burden of mental health conditions on rural and remote communities recommends longer-term and more flexible funding and contract processes, in addition to working with professional colleges to improve support and training of workers in rural and remote communities, with the goal of supporting high-quality workers and services to remain in communities, thereby providing consistency of service provision. importantly, our article suggests that rfds air medical retrievals are a symptom of this unmet demand and also a potential proxy for the services and capacity that currently does not exist in rural and remote communities. to provide high-quality mental health services to rural and remote communities will require adequate resourcing. although the costs to governments will likely be substantial, we suggest that the societal benefits that will be gained from resourcing action to meet the unmet demand are likely to outweigh these costs. in other words, the poor mental health outcomes experienced by people in rural and remote communities deserves and demands action. furthermore, we do not understand the impact of high-acuity mental illnesses, the high rates of suicide and substance use on the indirect (productivity) and intangible (quality of life) costs for rural and remote communities, and the australian society more broadly. it is important to quantify these costs because they are likely to be substantial and offset much of the costs related to the provision of high-quality mental health services for rural and remote communities. a strength of this article is that it has provided annual direct medical costs associated with air medical retrievals in australia. these costs have not been quantified before and are important because they can be used to assess the total costs associated with the current approaches to mental health service provision in rural and remote communities. a limitation of this study is that to apply hospital costs from the national hospital cost data collection, we mapped icd- -am codes (of which there are > , ) to the ar-drg codes costed by the national hospital cost data collection. as such, the costs reported here are an estimate of the costs to governments through the public hospital system. a further limitation was that we were unable to access the icd- -am codes that were listed for the initial hospital admission before interhospital transfers; therefore, we were unable to apply these costs. in conclusion, the direct medical costs of air medical retrievals for mental and behavioral disorders in australia's most remote communities are substantial. the societal implications of these costs to the families and communities of these regions is unknown; nevertheless, the flow-on effects of these societal costs are likely to far exceed the direct medical costs. we challenge policy and decision makers to understand these societal implications for future health policy and planning of mental health services in australia's rural and remote communities. australian institute of health and welfare. rural and remote health. canberra, australia: australian institute of health and welfare time to end the drought in the bush the orange declaration on rural and remote mental health suicide and hospitalised self-harm in australia: trends and analysis australia's future health workforce − psychiatry. department of health australian institute of health and welfare. mental health services in australia: mental health workforce tables time to end the drought in the bush australian institute of health and welfare. national drug strategy household survey : detailed findings royal flying doctor service covid- activity and surge modelling in australia health care access, mental health, and preventive health: health priority survey findings for people in the bush suicide and mental health in rural, remote and metropolitan areas in australia drought-related stress among farmers: findings from the australian rural mental health study department of health. mbs online. australian government methods for the economic evaluation of health care programmes consolidated health economic evaluation reporting standards (cheers) statement international statistical classification of diseases and related health problems, th revision the medical and retrieval costs of road crashes in rural and remote northern queensland independent hospital pricing authority. national hospital cost data collection report, public sector, round (financial year - ). canberra: ihpa who we are volume -main structure and greater capital city statistical areas aeromedical retrievals of people for mental health care and the low level of clinical support in rural and remote australia the traumatic experience of first-episode psychosis: a systematic review and meta-analysis the australian senate: community affairs references committee. accessibility and quality of mental health services in rural and remote australia acknowledgmentin-flight patient data were extracted from the confidential royal flying doctor service data set, and cost data for australian refined diagnosis related groups codes were sourced from the publicly available national hospital cost data collection ( / ) website.*address for correspondence: fergus gardiner, phd medicine, royal flying doctor service, , level , - brisbane avenue, barton, act , e-mail address: fergus.gardiner@rfds.org.au (f.w. gardiner). key: cord- - ynt d authors: glynn, r. w.; boland, m. title: ebola, zika and the international health regulations – implications for port health preparedness date: - - journal: global health doi: . /s - - - sha: doc_id: cord_uid: ynt d background: the outbreak of ebola virus disease in west africa in - was unprecedented in terms of its scale and consequence. this, together with the emergence of zika virus as a public health emergency of international concern in , has again highlighted the potential for disease to spread across international borders and provided an impetus for countries to review their port health preparedness. this report reviews the legislative framework and actions taken under this framework in advancing and improving port health preparedness in ireland, in response to the declaration of the public health emergency of international concern for ebola virus disease in august . findings: infectious disease shipping and aircraft regulations were brought into force in ireland in and , respectively. preparatory actions taken under these and the international health regulations necessitated significant levels of cross disciplinary working with other organisations, both within and beyond traditional healthcare settings. information packs on ebola virus disease were prepared and distributed to airports, airlines, port authorities and shipping agents, and practical exercises were held at relevant sites. agreements were put in place for contact tracing of passenger and crew on affected conveyances and protocols were established for the management of medical declarations of health from ships coming from west africa. conclusions: the outbreak of ebola virus disease in west africa resulted in significant strengthening of ireland’s port health preparedness, while also highlighting the extent to which preparedness requires ongoing and sustained commitment from all stakeholders, both nationally and internationally, in ensuring that countries are ready when the next threat presents at their borders. over the last few decades, a number of emerging infectious diseases have taken the global community by surprise including hiv, sars, h n , mers-cov and ebola virus disease (evd) [ ] . the outbreak of the latter in west africa in - was unprecedented in terms of its scale and consequence, and was responsible for the deaths of more than , people. the emergence of zika virus in latin america and the caribbean in - , meanwhile, has demonstrated that weaknesses in public health preparedness and response capabilities were neither unique to west africa nor to evd, and reiterate the need for renewed focus on these aspects of global health protection [ ] . it was with scenarios like evd and zika in mind that the international health regulations (ihr) were updated and brought into force in . their stated purpose and scope was 'to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade'. although the ihr are aimed at several areas of public health security they can be broadly summarized into two main areas; urgent actions to be taken with respect to acutely arising risks to public health and strengthening of national systems and infrastructure (core capacities) while ireland has no direct flights from the affected countries in west africa, a significant number of travelers who leave that area arrive in ireland as their final destination. at least , people travelled from the region to the uk alone between september and december , for example, and it can be expected that a reasonable number travelled onwards to ireland. in addition, ireland also had to contend with significant numbers of returning humanitarian aid workers from the region; between december and november , of these workers returned to ireland from their posts in west africa. although ireland has no direct airline traffic from west africa, a number of ships do travel directly from there with cargo and hence there was heightened concern that a crew member may arrive with symptoms. rusal aughinish in county limerick, for example, is europe's largest bauxite refinery. bauxite is used to make aluminium and guinea was the sixth largest global producer in [ ] . ireland is a key export market for guinea, with over $ million worth of bauxite imported from there annually. the shipping traffic to ireland from west africa was therefore significant, with at least ships arriving at irish ports between august and may , having previously called at ports in the affected countries. this paper aims to discuss the multisectoral work which was involved in advancing and improving port health preparedness in ireland, in light of the ihr and, in particular, in light of the outbreak of evd in west africa in . with the ihr's requirement to strengthen core capacities in mind, the infectious disease (id) shipping regulations and the infectious disease aircraft regulations were set down in ireland in and . while both sets of regulations outline a schedule of infectious diseases to which they apply, this schedule reflects a key feature of the ihr in that it also provides for the inclusion of unspecified, novel threats of international importance, should they arise ( table ) . the id shipping regulations identify ireland's five designated ports and set out the responsibilities of ships' masters and port health authorities at these ports. the legislation requires ships' masters to complete a maritime declaration of health (mdh) where requested to do so by local port health authorities. it also provides for the inspection and detention of ships and for the removal of arrived ships to a mooring station. furthermore, it mandates the provision of a ship sanitation control exemption certificate or a valid ship sanitation control certificate and outlines the necessary actions where these are not forthcoming. the id aircraft regulations set out the duties of the crew and commander of aircraft and those in charge of airports, and the powers and duties of health officers. in particular, the aircraft regulations set out the powers of the health officer in relation to the detention and inspection of aircraft and the inspection of passengers on board aircraft. in an ihr assessment group report made a number of recommendations in relation to preparedness in ireland. a medical officer of health (moh) port health committee was established as part of the response to this report. the terms of reference of this committee, which consists of specialists in public health medicine, are ) to act as a forum for sharing experience and knowledge regarding preparedness for, and response to, communicable disease incidents at points of entry, and ) to organise training and desktop exercises to test the guidelines that have been produced. in addition, the group also aims to progress multidisciplinary working in relation to port health. in ireland, evd preparedness was coordinated nationally in the health service through the department of health and ireland's designated international focal point, the health protection surveillance centre (hpsc). following the declaration of the evd outbreak as a public health emergency of international concern dengue fever, rift valley fever and meningococcal disease and any other infectious disease in respect of a person on board an aircraft originating in, coming from, or having passed through an area where any of those infectious diseases are of special national or regional concern. any other infectious disease which is of public health concern and of international importance (pheic), the work of the port health committee (hereafter referred to as 'the committee') involved liaison with multiple other groups and organizations, including the hpsc, port and airport management, customs and immigration officials, the office of emergency planning, environmental health and a number of government departments. during this period, the committee also worked in collaboration with the health service's port health group, whose membership comprises public and environmental health, the department of emergency planning and the national ambulance service (nas) (fig. ) . the committee aimed to improve knowledge and awareness for points of entry authorities (ports and airports), to assist in early detection of potentially infected persons, to disseminate health information for travelers, to develop protocols for assessment and case management, to ensure infection prevention and control at points of entry and to assist in implementing world health organisation (who) recommendations related to the management of evd [ ] . the first information pack for airlines and airports was distributed to them on the th august . this contained general advice about ebola and the areas affected, advice for airline and cabin crew regarding necessary actions in the event of a suspected case on board a flight, as well as advice for cleaning and air cargo personnel. some of the airports then sought additional advice for specific staff groups such as baggage handlers and immigration officers and presentations were prepared and given to the relevant stakeholders. in november , information leaflets and posters in english, irish and french were prepared and distributed through to ireland's six airports (fig. ) . in february updated guidance was issued containing additional information for airport and airline staff in view of how the global situation had evolved over the preceding months. work was also done to progress general preparedness and strengthening at our airports. in january , for example, the evidence regarding contact tracing of passengers on board a flight with a suspected case was reviewed in light of how this had been managed internationally. the guidance of international organizations including that of the european centre for disease prevention and control (ecdc) was reviewed and a position statement, in which it was proposed that only passengers who were one seat away from the index case should be traced back, was accepted by ireland's scientific advisory committee. passenger locator forms and on-board announcements for passengers were developed and airports were supplied with a stock of these forms. contact tracing agreements were established with the nas and the committee contributed to the development of an updated management algorithm for members of that service. the period saw the development of relationships with airport and airline authorities, a multidisciplinary desktop meeting was held in november and a practical repatriation exercise was carried out at dublin airport in january . a similar pattern of work was required in relation to ireland's shipping ports. guidance was issued, this time in conjunction with the environmental health service, in september . presentations were given as required to specific groups including harbourmasters, and fig. collaboration between the port health committee and other groups and organizations in ireland information leaflets and posters were distributed to ports for display in terminals and on passenger ferries (fig. ) . a protocol was agreed between environmental health and public health for the management of mdh from ships coming from affected areas, both in and out of hours. a practical exercise was held at rusal aughinish and again the period was used to develop and strengthen working relationships with all of the stakeholders involved. from a public health perspective, globalization means that a health threat in one country puts all at risk. in the case of evd, people with infection crossed borders within africa and to europe and to north america where they unintentionally caused small chains of transmission far from the outbreak's epicentre [ ] . the actions taken globally in relation to evd -and more recently zika -have highlighted many of the inadequacies inherent within the international response mechanisms aimed at dealing with these crises, and health systems therefore need to be strengthened and prepared, not just for evd and zika, but for all new and emerging diseases which hold outbreak potential [ ] . in ireland, preparedness activities undertaken between august and march facilitated the development of cross-disciplinary working within the health service and forged relationships with external stakeholders including those at our ports and airports, and across government departments. progress was also made at the operational level, with clarity brought to case and contact management through the development of agreed protocols. while welcome, this work also highlighted the extent to which preparedness requires ongoing and sustained commitment from all stakeholders, both nationally and internationally, in ensuring that countries are ready when the next threat presents at their borders. government and global emerging infectious disease preparedness and response. henry j. kaiser family foundation beyond the ebola battle -winning the war against future epidemics guinea country mining guide. kpmg international: kpmg global mining institute ebola event management at points of entry. geneva: world health organisation global health security: the wider lessons from the west african ebola virus disease epidemic it takes threat of ebola to see lessons from low income countries. england: global health none. both rg and mb conceived and wrote this paper and have approved the final draft. the authors declare that they have no competing interests. • we accept pre-submission inquiries • our selector tool helps you to find the most relevant journal submit your next manuscript to biomed central and we will help you at every step: key: cord- - ngeaoid authors: komro, kelli a. title: the centrality of law for prevention date: - - journal: prev sci doi: . /s - - -x sha: doc_id: cord_uid: ngeaoid nan the field of prevention science has been instrumental in the development and testing of strategies to promote mental, emotional, and behavioral (meb) health among children and youth. yet, despite an abundance of scientific evidence of effective programs, little progress has been made in scaling up and creating structural change to support healthy development for all children ; national academies ). the national academies of sciences, engineering, and medicine's (the national academies) board on child, youth, and families consensus study report entitled fostering healthy mental, emotional, and behavioral development in children and youth (national academies ) concludes that a national agenda including institutional and policy change is central to achieve improved and lasting outcomes at the population level. the report is the third in a series on meb development published since that have synthesized evidence and provided recommendations for promotion of healthy development and prevention activities (institute of medicine ; national research council and institute of medicine ; national academies ). the report includes a greater emphasis on achieving population-level effects through institutional and policy change. "this emphasis reflects the fact that despite the development of programs that are effective in supporting healthy meb development in individuals and groups of children and youth, successful population-based efforts that can broadly counter adverse environments and experiences that threaten healthy meb development for so many of the nation's young people have not materialized." (p. vii). conclusions of the consensus study highlight broad societal factors, such as poverty, inequality, and discrimination, as key influences on meb health, and recommend a coordinated national agenda to address healthy meb development universally with particular attention to geographic areas of concentrated disadvantage. given its emphasis on achieving population-level effects, the consensus study dedicated a chapter to research on policies (national academies ). in this chapter, guided by conceptual frameworks of policy effects on child health and health equity (komro et al. (komro et al. , solar and irwin ) , i illustrate the multitude of laws and central mechanisms through which laws may influence child health ( fig. ) . below, i briefly summarize research from a few key areas included in the commissioned paper that i wrote for the consensus study, including results from foundational public health law research on the effectiveness of laws designed to protect children from physical harms and emerging research on policies that address social determinants of health. the long-standing fields of injury prevention and alcohol and tobacco control have often pointed the way on use of strong research designs such as controlled time-series to assess effects of laws on health. sophisticated research methods are increasingly being applied evaluating health effects of laws that affect the upstream social determinants of health. there is strong science behind the effectiveness of laws designed to prevent child injury. quasi-experimental studies have found that laws requiring child safety seat use result in substantial increases in correct use of child restraint, reductions in crash injury rates, injury hospital expenditures, and motor vehicle fatalities (eichelberger et al. ; mannix et al., ; pressley et al. ). studies have concluded that bicycle helmet legislation results in an increase in the use of bicycle helmets among youth, and a corresponding decrease in head injuries among children (karkhaneh et al. ; macpherson and spinks ) . graduated driver licensing laws have been found to reduce crash rates and injuries among teen drivers, with stronger laws associated with greater fatality reductions (russell et al. ). there is inconsistent evidence of whether firearm access prevention laws (i.e., safe storage) and juvenile age restrictions prevent firearm injuries, with some evidence that the strength of the law is related to the size of beneficial effects (gius ; hamilton et al. ; parikh et al. ) . research can also indicate when law is ineffective, or poorly implemented. for example, concussion-related policies for youth athletes typically do not address primary prevention, instead dealing with responses to a concussion, such as criteria for removal from play, requirements for evaluation, requirements for return to play, and information dissemination. following implementation of such laws, a study found that emergency department visits and neurologist visits continued to increase at the rate they did before implementation (gibson et al. ) , indicting the laws are ineffective. decades of quasi-experimental studies have provided a solid scientific basis for concluding that effective policies designed to prevent and reduce alcohol-related harms among youth include raising the minimum drinking age to , increasing alcohol excise taxes, and imposing liability on social hosts (us department of health and human services a). in addition, laws that deal specifically with drinking and driving, such as zero tolerance for any alcohol concentration among minors, result in declines in alcohol-related traffic fatalities (us department of health and human services a). similarly, effective youth tobacco prevention policies include restricted access to tobacco products and tax and price increases (us department of health and human services ). use of e-cigarettes is a rapidly emerging public health concern which are now the most commonly used tobacco products among youth (us department of health and human services b). research is needed to study the effects of new legal and regulatory efforts to prevent initiation among youth. research is also needed to study effects of newly enacted medical and recreational marijuana laws. initial studies have found that states with decriminalized or legalized marijuana have higher rates of unintentional overdose among young children, usually through ingestion (onders et al. ; wang et al. ) . initial studies on adolescent marijuana use have been inconsistent (cerda et al. ; kerr et al. ; sarvet et al. ). for decades, laws have addressed air, water, and land pollution, although enforcement of such laws is currently at risk and new laws will likely address threats from global warming. yet, there is limited research that has examined effects on such laws on child health and development. two important examples of this line of research are studies that have documented long-term effects from key federal legislation regulating clear air and exposure to lead. isen et al. analyzed long-term effects of the clean air act of on air quality at birth and subsequent adult labor market outcomes. they found that better air quality at birth was associated with improved educational attainment, earnings, and later-life health. a report from the health impact project of the robert wood johnson foundation ( ) summarized research findings that indicated a % decline in average blood lead levels among children following key federal legislation to reduce lead exposure enacted during the s to s. further research is critically important to study effects of new laws to regulate or deregulate exposures to toxic environmental exposures on child health and develop. there is growing evidence that enhancing family income through such policies as the earned income tax credit (eitc) and minimum wage laws affects family and child well-being. numerous studies indicate that federal and state eitcs positively affect families' economic circumstances; increase participation in the labor force, particularly by single mothers; reduce poverty, including child poverty; improve educational outcomes among children; and improve health outcomes among mothers and children (gassman-pines and hill ; sherman et al. ; spencer and komro ) . studies of state minimum wage laws find that increases in minimum wages are associated with improvements in prenatal care, birth weight, and fetal growth; and decreases in low birth weight, post neonatal mortality, and maternal smoking (komro et al. ; wehby et al. ) . higher minimum wage laws also appear to be associated with lower reports of neglect for children ages to years (raissian and bullinger ) and lower adolescent birth rates (bullinger ), yet higher rates of binge drinking and alcohol-related traffic fatalities (adams et al. ; hoke and cotti ) . research on health and well-being effects of these and other related policies (e.g., child tax credit, paid family leave) designed to support family economic security is important to guide future policy decisions. studies have found that receipt of housing vouchers among families with children results in reduced homelessness, crowding, housing instability, and family poverty (center on budget and policy priorities ). yet recipients of housing vouchers tend to live in only slightly less disadvantaged neighborhoods (ellen et al. ; horn et al. ) . evidence also suggests that rental voucher programs may reduce exposure to crime and neighborhood social disorder, but further research is needed to understand effects on youth outcomes (anderson et al. ). the supplementary nutrition program for women, infants, and children (wic) has been found to improve nutrition and health of low-income families, and importantly improves academic achievement among children. studies also indicate the benefits of the supplemental nutrition assistance program (snap), including reduction of food insecurity among children, family purchases of healthier food, fewer low-birth-weight births, and improved child health (carlson and keith-jennings ) . the national school lunch program is associated with the consumption of more nutritious food and lower rates of family food insecurity (ralston et al. ). as briefly summarized here, the report documents growing evidence of laws that foster healthy development (national academies ). given the importance of broad societal-level influences on healthy meb development, additional research on the breadth of consequential laws, especially those that may alter social determinants of health, is urgently needed. there are important opportunities for the field of prevention science to expand and fill important research gaps in the related and growing field of public health law research. public health law research is defined as the scientific study of the relation of law and legal practices to population health (burris et al. ) . advancing scientific methods, including more sophisticated theory and improved quasi-experimental designs, provide the tools for improving causal inference regarding law's effects on health and well-being (wagenaar and burris ) . the application of theory and methods from prevention science to public health law research provides an important opportunity to move both fields forward, specifically in the following three key areas. first, prevention scientists bring expertise in experimental and quasi-experimental methods that can improve the rigor of law research. the application of experimental research designs to study laws and policies that address social determinants of health is in its infancy. prevention science can contribute by studying effects of specific policy innovations with intensive longitudinal designs, such as interrupted time-series analysis. it is equally important to study policy replications using other quasi-experimental design approaches. scientists do not control when and where policies are enacted and how they are implemented, and thus cannot randomly assign the legal "treatments" to some and not to others. many research design elements that are familiar to prevention scientists, such as comparison jurisdictions and intensive longitudinal data, can be incorporated in evaluations of laws to produce accurate estimates of the size of a law's effect with high levels of confidence that an observed effect is caused by the law (wagenaar and komro ; shadish et al. ) . combining design elements produces the strongest possible evidence on whether a law caused the hypothesized effect and magnitude of that effect. in this way, the application of rigorous quasi-experimental methods will provide strong evidence to support policymaking to improve health and well-being. second, rarely have mechanisms of how policies affect outcomes been studied, especially through formal mediation analyses. the field of prevention science has articulated theoretical and methodological standards for the study of causal mechanisms through mediation analyses (gottfredson et al. ; mackinnon et al. ) ; wiedermann et al. ) . theory, measurement of hypothesized mediators, and mediation analysis would contribute to the existing scientific basis of laws' effects on meb development, health, and well-being. third, studies related to scaling up, diffusion, implementation processes, and cost-effectiveness are limited and would advance the science around optimal approaches for scaling up laws and policies. prevention science methods related to translation research and implementation science of evidence-based interventions (gottfredson et al. ; spoth et al. ) can also be applied to policy research. mixed method studies to incorporate qualitative components can be applied to address questions of how a law was crafted, passed, or implemented (woods ). economic evaluations of laws perform the same function as evaluations of other preventive interventions-whether a law's benefits, as measured by health outcomes or cost savings, exceed its costs (miller and hendrie ) . in conclusion, there is accumulating evidence of societallevel influences on meb development and health (national academies ), including a growing field of research that supports the centrality and importance of law for prevention. the covid- pandemic's health disparities are yet another tragic example of the urgency for scientists to provide evidence of effective laws to protect and promote health equity. for example, research is needed to examine effects of the rapidly changing landscape of laws on paid family leave, universal health care, labor law, unemployment insurance, and minimum wage laws. prevention scientists have much to offer this emerging field with sophisticated theory, experimental and quasi-experimental research designs, advanced statistical methods for outcome and mediation analyses, and dissemination and implementation research methods. prevention scientists can contribute to the empirical study of laws that shape the many systems that affect healthy development, research findings that are critical for evidence-based policymaking. rigorous science using controlled time-series natural experiments and persuading policy makers to take the resulting findings into account is of utmost importance for the protection and promotion of child and family health. minimum wages and alcohol-related traffic fatalities among teens providing affordable family housing and reducing residential segregation by income the effect of minimum wages on adolescent fertility: a nationwide analysis making the case for laws that improve health: a framework for public health law research snap is linked with improved nutritional outcomes and lower health care costs policy basics: federal rental assistance medical marijuana laws and adolescent use of marijuana and other substances: alcohol, cigarettes, prescription drugs, and other illicit drugs effects of booster seat laws on injury risk among children in crashes why don't housing choice voucher recipients live near better schools? insights from big data scaling up evidencebased interventions in us public systems to prevent behavioral health problems: challenges and opportunities how social safety net programs affect family economic well-being, family functioning, and children's development analyzing the effect of state legislation on health care utilization for children with concussion the impact of minimum age and child access prevention laws on firearm-related youth suicides and unintentional deaths standards of evidence for efficacy, effectiveness, and scale-up research in prevention science: next generation variability of child access prevention laws and pediatric firearm injuries minimum wages and youth binge drinking reducing risks for mental disorders: frontiers for preventive intervention research every breath you take-every dollar you'll make: the long-term consequences of the clean air act of effectiveness of bicycle helmet legislation to increase helmet use: a systematic review changes in undergraduates' marijuana, heavy alcohol and cigarette use following legalization of recreational marijuana use in oregon creating nurturing environments: a science-based framework for promoting child health and development within high-poverty neighborhoods social determinants of child health: concepts and measures for future research the effect of an increased minimum wage on infant mortality and birth weight the correspondence between causal and traditional mediation analysis: the link is the mediator by treatment interaction bicycle helmet legislation for the uptake of helmet use and prevention of head injuries booster seat laws and fatalities in children to years of age cost-effectiveness and cost-benefit analysis of public health laws fostering healthy mental, emotional, and behavioral development in children and youth: a national agenda marijuana exposure among children younger than six years in the united states pediatric firearm-related injuries in the united states motor vehicle occupant injury and related hospital expenditures in children aged years to years covered versus uncovered by booster seat legislation money matters: does the minimum wage affect child maltreatment rates? children's food security and usda child nutrition programs, eib- policies to prevent and respond to childhood lead exposure: an assessment of the risks communities face and key federal, state and local solutions graduated driver licensing for reducing motor vehicle crashes among young drivers medical marijuana laws and adolescent marijuana prev sci use in the united states: a systematic review and meta-analysis experimental and quasiexperimental designs for generalized causal inference boosting low-income children's opportunities to succeed through direct income support a conceptual framework for action on the social determinants of health family economic security policies and child and family health addressing core challenges for the next generation of type translation research and systems: the translation science to population impact (tsci impact) framework preventing tobacco use among youth and young adults: a report of the surgeon general facing addiction in america: the surgeon general's report on alcohol, drugs, and health e-cigarette use among youth and young adults: a report of the surgeon general department of health and human services, centers for disease control and prevention, national center for chronic disease prevention and health promotion public health law research: theory and methods natural experiments: research design elements for optimal causal inference without randomization association of unintentional pediatric exposures with decriminalization of marijuana in the united states effects of the minimum wage on infant health testing the causal direction of mediation effects in randomized intervention studies using qualitative research strategies for public health law evaluation publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgments i would like to acknowledge shelby rentmeester, mph, project director, emory university rollins school of public health and shenita r. peterson, mph, public health informationist, emory university woodruff health science center library for their assistance with the literature search. key: cord- -z l dvyd authors: hotopf, matthew; bullmore, ed; o'connor, rory c.; holmes, emily a. title: the scope of mental health research during the covid- pandemic and its aftermath date: - - journal: the british journal of psychiatry : the journal of mental science doi: . /bjp. . sha: doc_id: cord_uid: z l dvyd the effects of the covid- pandemic on population mental health are unknown. we need to understand the scale of any such impact in different sections of the population, who is most affected and how best to mitigate, prevent and treat any excess morbidity. we propose a coordinated and interdisciplinary mental health science response. it is self-evident that the covid- pandemic has profound consequences for individuals and societies. most research has understandably been focused on understanding the dynamics of the pandemic and the biology of the infection in order to develop diagnostics, vaccines and treatments. however, we know that, with time, the current spike of infections will pass. there will be headline mortality figures and infection rates, lessons learned about emergency preparedness, debates about the merits of competing strategies to control the infection, but as the rate of new infections continues to slow, schools will reopen and some semblance of normality will return. however, the impact of the pandemic on human health is likely to be felt for much longer than the first wave of severe illness and death. the long-term effects of sars-cov- , the virus that causes covid- , on those who recover from the acute respiratory phase of covid- are unknown. just over one-third of patients with covid- in wuhan had neurological symptoms noted in their case notes, with anosmia and ageusia recognised as early symptoms unrelated to mucosal congestion. other coronaviruses are neurotropic and capable of infecting neurons trans-synaptically. the immune response to infection could also have adverse effects on brain function. it is possible that infection or inflammation of homeostatic centres of respiration in the brain-stem may contribute to respiratory distress or failure. in the longer term, parkinsonian symptoms were an important late complication of the - influenza pandemic, and neuropsychiatric complications may similarly arise following sars-cov- infection. as yet, virtually nothing is known of the neuropathology of the infection. however, even without direct effects on the brain, long-term mental health consequences might be anticipated. mental disorders and cognitive impairments are common following treatment in intensive care. the systemic effects of infection, including cytokine storms as part of intense inflammatory or autoimmune response, combined with the mortal threat of the illness, constitute major biological and psychological stresses. it is plausible that there may be post-traumatic stress reactions, persistent fatigue, depression or physical symptoms of unclear aetiology as a chronic consequence of this acute combination of infection, health anxiety and heightened stress. however, for all of usnot just those infected or seriously illthe psychosocial impacts of the pandemic are profound. the closure of schools, nurseries, pubs, shops, gyms and workplaces; the effect of self-isolation and loneliness, particularly for older people and those with multiple morbidities; the potential of self-isolation to exacerbate adverse home environments for children as well as adults, including domestic violence and abuse; the loss of employment, particularly for those with the most precarious working lives; the misinformation, confusion and, for some, anger around government policy; and the unprecedented restrictions on liberty resulting from public health measures to stem the pandemic affect every part of society, although those already disadvantaged will be most affected. we have already seen evidence of the pandemic having particularly adverse outcomes for people from black and minority ethnic groupsthese differential effects on mental and physical health need to be better understood. the longer-term impacts of a likely recession may ultimately have a more significant effect on healthparticularly mental healththan the crisis itself. it is unknown whether or how these changes in our lives will affect mental health, and therefore research to monitor self-harm and suicide and the prevalence of mental and substance use disorders in the general population and populations at particular risk is vital. people with mental disorders may be particularly susceptible to these wider societal impacts. the anxieties associated with the pandemic may be more salient to people with pre-existing disorders for example those with obsessive-compulsive disorders may be particularly affected by advice to hand-wash, or those with psychotic disorders may be more prone to subsume covid-related threat preoccupations into delusional systems. there are significant challenges in delivering mental healthcare, particularly to those with the most severe difficulties, with the pandemic affecting already depleted staffing complements. much routine mental healthcare has suddenly been curtailed or is now delivered remotely via video conferencing. what impact this has on the quality of patients' care is unknown. meanwhile for the health and social care workforce, from the front-line staff in acute medicine and intensive care units to those helping frail elderly care-home residents, there are well-publicised challenges in terms of high job demands, lack of personal protective equipment, an atmosphere of heightened threat and potential 'moral injury'the psychological impact of being forced to make hard choices that jar against the individual's ethical norms. a group convened by the mental health research charity mq and the academy of medical sciences has now developed a series of recommendations, published in the lancet psychiatry, to prioritise the research agenda for mental health science in the covid- pandemic. the work of the group was informed by a rapid public consultation and collaboration with experts with lived experience and other research consumers, including senior clinicians. our single most important message is the need for high-quality mental health research as part of the wider research response to the pandemic. nowhere is the case for integrating mental and physical health more pressing than in our response to the pandemic. there is a relatively short window of time in which to act. existing infrastructure, data assets and expertise need to be mobilised, with funding put in place to respond. there are effectively three types of questions to answer, discussed in the paragraphs below, which apply to virtually every group affected by the pandemic. who is most affected? why and how are they affected? and what can be done to prevent, mitigate or treat problems faced by these groups? it is necessary first to understand the impact, if any, of the pandemic on various mental health outcomes across society. for the general population has there been an increase in suicide or self-harm, anxiety or depression? for people with pre-existing mental disorders, has the mortality gap widened as a result of their multiple disadvantages? for children and young people, has the prolonged period of school and university closure and uncertainty about exams affected their mental health? there is a need for epidemiologically robust methodsusing either administrative data from health records (or similar systems) or by constructing new surveys. although there have been many surveys delivered via social media, these are self-selecting and are likely to exaggerate health impacts. for the national health service (nhs), employers have a duty of care to understand the effects of work on their employees, much as the military does during and after deployment. why and how are they affected? we then need to understand mechanisms to explain why some individuals are more affected than others and how. that is, to be able to inform mental health interventions, the types of mechanism we are most interested in are those that are both causal and modifiable. these mechanisms will range from molecular and physiological to psychological and societal. in understanding long-term outcomes for people with severe covid- illness, it will be necessary to resolve whether any effect on mental health arises from the possible neurotropic action of the virus, a more general impact of the 'cytokine storm' that accompanies severe systemic infection, or the alarming experience of being mortally ill, as related to post-traumatic stress reactions. we need to better understand the psychological mechanisms that account for changes such as anxiety, depression, self-harm and suicide more generally in the population. this understanding will inform the development of new mechanistically based psychological treatments that can be delivered under pandemic conditions. next, there is a need to know whatif anythingshould be done to intervene, bearing in mind that the current surge of cases of covid- may be only the first in a series of spikes in incidence, and research conducted now may usefully inform responses to future waves of infection. research can identify not only benefits of treatments, but also the harms of well-meaning interventions, for example debriefing following traumatic incidents. it is important that the pandemic response does not exacerbate existing social and health inequalities. the need to provide interventions at scale and remotely means that various modalities of digital intervention will inevitably dominate. digital tools can operate on a spectrum from providing information to being used as a vehicle for delivering psychotherapies. we urge caution though, because only a few of the thousands of apps already available have a robust evidence base. it is vital that such tools are robustly evaluated before implementation. randomisation and evaluation of competing digital systems could be a condition of any roll out in the nhs. individual-based interventions are not the only approach and in many settings the response may be best conceptualised as a social one. communitylevel interventions and volunteering that focus on altruism are an increasingly prominent response to the pandemic, which may have direct mental health benefits. for front-line healthcare workers structural responses relating to rotas and breaks, getting sufficient sleep, team working and practical support from employers may be more appropriate than individual-level interventions. effective population health messaginggetting people to follow expert advice to reduce risk of covid- infectionis critical not just for minimising anxiety that may otherwise contribute to mental health complications but more generally for boosting adherence to social distancing and other measures intended to slow transmission of the virus. we need to know this urgently to help in face of future waves of the pandemic. if research is to address the diverse challenges to mental health of the covid- pandemic, several conditions need to be met. first, no single discipline will be able to address the problem alone. we call for mental health science, which we see as a multidisciplinary endeavour, combining psychiatry and psychology, neuroscience and neurology, social sciences, epidemiology and public health, and lived experience, to work together in responding to this crisis. second, it is critical that there are open, two-way channels between consumers (patients, public and policy makers) and producers of mental health research, so that scientists are oriented to the questions that matter most to the public, and policy-making is properly informed by the best evidence available. third, cooperation within and between sectorsresearch funders, universities, the nhs, industry and charitiesis critical to the rapid and coherent deployment of existing infrastructure for mental health research. fourth, definitive and impactful research will require national and international coordination, to ensure that protocols and computer code are shared, measures are harmonised, and work is done at scale, with the principles of open science at heart. although we must act urgently, we must also be strategic and joined-up in how we address this challenge from the outset. our success in understanding and mitigating the biological, psychological and social impacts of covid- on mental health will require new investment from research funders and coordinated action from the entire community of mental health scientists. neurologic manifestations of hospitalized patients with coronavirus disease in wuhan, china suicide risk and prevention during the covid- pandemic managing mental health challenges faced by healthcare workers during covid- pandemic multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science the lancet psychiatry commission on psychological treatments research in tomorrow's science the four authors contributed to a mental health prioritisation exercise. m.h. drafted the editorial and all authors edited it and approved the final version. key: cord- -ttjja r authors: kahambing, jan gresil s.; edilo, shienazile r. title: stigma, exclusion, and mental health during covid : cases from the philippines date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: ttjja r nan this is a pdf file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. this version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. amid the coronavirus disease pandemic, the world health organization (who) called for considerations that might include stigma and social exclusion as mental health and psychological concerns. the editor of the journal has thus justly linked the relevance of the crisis to psychiatry as it has effects on mental health (tandon, ) . psychiatry is vital in the crisis since it exposes psychosocial problems that, in the case of mental health, feed on the response of the people and society at large (tandon, ) . mackolil & mackolil ( ) then lists anxiety and stigma and their proliferation as contextual effects of misinformation, uncertainty, hesitation to 'disclose or seek help,' fear, and 'unawareness about [sic] health promoting strategies.' in the philippines, some provinces have a lesser number of covid cases due to quarantine measures and distance from the metropolises with a densely larger population. for the first five months (january to may), the province of southern leytepart of the eastern visayas region of central philippinesenjoyed zero positive cases. as of the th of june, however, there are already with total cases in the region (department of health, region viii, ). but the following cases were before the announcement of those who got positive results. one of the crucial aspects that may stem from this is the fact that stigmatization and exclusion may not necessarily be tied to empirical evidence but only in the criterion of whether or not the cases fit the contextual 'shared belief.' there is informed consent from the case persons for the publication of the study. this is a young priest of the iglesia filipina independiente (philippine independent church) in padre burgos, southern leyte. he was objectively well and healthy and actively serving his church. but he was allegedly discriminated by his parishioners due to misconceptions. exploration of the history revealed that while driving home, he mentioned that he passed by a man he recognized and let him in the car since they were heading to the same destination. the man was said to be in contact with a suspected covid case and was therefore thought to be exposed. the news spread around their church that immediately caused ruckus and fear to their community. the people in their church discriminated him including his altar boys to the point that harsh words were hurled at them. almost everyone deliberately avoided them. the priest was very upset and hurt after learning this. this resulted in anxiety around his parishioners. he felt specially excluded and shied away because these people were no strangers to him. the manner of exclusion derails some of his relationships, even to his close friends. he was very worried that his case was not an ordinary incident of prejudice leading to stigma because he represents the church as its pastor and he provides service to those who need spiritual support. "how can i work efficiently if the people are getting rid of me?" he said. a conference held with his fellow clergy and their bishop days after the incident showed the pandemic's effect on him and their churches. his instance of discrimination became a tool for social exclusion and this sadly includes his fellow churchmen. this is a -year-old institutional worker of a privately owned hospital in sogod, southern leyte. he was discriminated by his workmates after learning that he suffered from flu-like symptoms. he was advised by the attending physician to self-isolate for days at home as per the covid prevention protocol. luckily, it was just ordinary flu and he came back at work after the advised length of time. however, upon returning, his colleagues regarded him indifferently. some of his close friends at the hospital, for instance, advised him to just go home and leave. though in a form of jest, some said they would sign a petition to let him be suspended for several days. these kinds of remarks created psychological inputs for him since the jokes resemble a certain degree of seriousness and truth in them. additionally, the bantering that borders on bullying becomes physical when he was intentionally avoided by some. openness seemed to be blocked especially when he tries to start a conversation with them. due to the degrees of 'hostility' that he claims to have experienced when he got back to work, he developed resentment against his colleagues due to the incident. he was unable to work properly and was therefore unable to finish his job efficiently. this has caused many absences. with the drive to work and social interaction impeded, self-doubt, lowered self-esteem, and feelings of vulnerability from being excluded prevailed in his disposition. the impact of this situation has a certain traumatic element as this was for him the first time that he experienced such treatment. health care workers in the philippines often suffer from the abuse that comes from stigma (reuters, ) and this was shown even among themselves in the second case. in the first case, there is the denial of access to the benefits of the group, as the priest can no longer enjoy the j o u r n a l p r e -p r o o f company of his parishioners. this denial forms part of the negative effect on the health of those socially excluded (samers, ) . without comfort from contemporaries, the situation may not be effectively handled. having a good and empathetic support group and confidence in one's belief are potential factors for recovery. on the other hand, what the second case shows is a kind of disempowerment that is a negative result of stigma and exclusion (kai & crosland, ) . the disempowered perform less in their functions and lose motivation in the workplace, which can jeopardize the outcome of the workforce. emphatic interventions at home or providing safe places for openness with friends can help ease the effects of exclusion. good management support from hospitals must also assure employees that evidence-based results must prevail over false beliefs. moreover, both case persons were young. this has to be taken seriously since "mental health problems early in life can be associated with a trajectory of exclusion and disadvantage" for example through "reduced participation" or "exclusion from civil society" (evans-lacko et.al, ) . one critical problem in the philippines is not xenophobic as in multiracial societies but the misinformation or the hesitance to confer with verified information that provokes discrimination. the authors certify that they have each made a substantial contribution so as to qualify for authorship. none. j o u r n a l p r e -p r o o f the state of the art in european research on reducing social exclusion and stigma related to mental health: a systematic mapping of the literature lockdowns case of mass hysteria perspectives of people with enduring mental ill health from a community-based qualitative study addressing psychosocial problems associated with the covid- lockdown covid- : philippines health care workers suffer abuse, stigma imigration, 'ethnic minorities', and 'social exclusion' in the european union: a critical perspective the covid- pandemic, personal reflections on editorial responsibility world health organization, . world health organisation. mental health and psychosocial considerations during the covid- outbreak the authors would like to thank the case persons for their openness. jan kahambing would like to thank april cabezada and leo omamalin for their constant updates on the cases.j o u r n a l p r e -p r o o f none.. key: cord- -h pcatvx authors: hanson, claudia; waiswa, peter; pembe, andrea; sandall, jane; schellenberg, joanna title: health system redesign for equity in maternal and newborn health must be codesigned, country led, adapted to context and fit for purpose date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: h pcatvx nan in this edition of bmj global health, roder-dewan and colleagues suggest ways in which we might rethink care models to close the equity gap in maternal and newborn health. their analysis article follows from the work of the lancet global health commission on high-quality health systems, proposing design reforms with quality at the centre. the authors suggest that all childbirth care services should be moved to hospitals in all countries, combined with improvements in ( ) the quality of care provided in these facilities; ( ) transportation from home to hospital; and ( ) continuity of care through hub-and-spoke arrangements. we agree in principle with the need to shift childbirth care services towards higher level facilities. the quality of care provided to women and their newborns in low and middle-income countries (lmics) is inadequate. economic development and advances in communication and transportation should redefine the paradigm of proximity to care. also kruk and colleagues estimated that more lives are lost today due to substandard care than due to limited geographical access. so it is important to rethink where and how childbirth care should be made available. however, such health system redesign needs to respond to local needs and bottlenecksthat is, redesign must centre human resources, particularly midwifery providers; respond to the local context; and be fit for purpose. to cite lynn freedman, 'the point is not that global strategies, evidence-based guidelines, or high-level monitoring and accountability initiatives are inherently wrong or unnecessary. but when they consume most of the oxygen in the room, drowning out voices and signals coming from the ground, they distort both understanding and action. ' redesigning maternal and perinatal care needs to be done with a view to strengthening district health systems in a sustainable and crisis-resilient manner-as the ongoing covid- pandemic reminds us. to prompt an open and transparent debate, informed by local insight and strategies based on evidence, we present here our own thoughts and reflections on how to take this agenda forward. first, roder-dewan and colleagues propose that the present strategy of promoting childbirth care in primary health facilities may be the primary reason for improvements in maternal and newborn survival being less than anticipated. numerous studies indicate that primary facilities, which generally have a low case load, provide substandard care. however most-if not all-of the present analysis is based on cross-sectional data; interpretation is inherently complicated by reverse causality and circular loops in thinking, as health planners wisely prioritise investments in equipment and upgrading of services of higher level and high case load facilities. as a result, we do not know the quality of the care that primary facilities could provide if they would be staffed and equipped according to standards. however, we agree that case load must be considered-although we believe there is still no consensus on what the preferred volume of cases in childbirth facilities should be. the discussion on the place of delivery is missing a debate on the skills of the providers. the skilled birth attendant strategy, which stems from the millennium development goals era, was primarily informed by experience of midwifery based on the concept that skills and competences are the most important attributes for high-quality childbirth care. however, skilled birth attendant training bmj global health in the past years has often prioritised quantity over quality by opening fast-track -year or -year training, a strategy which ignored the complexity of pregnancy care and in particular childbirth care. in a study including almost pregnant women, gabrysch and colleagues reported that, to their surprise, there was no evidence of better maternal or newborn survival for those living closest to a facility offering highquality care at birth, although there was evidence of a reduced risk of intrapartum stillbirth. this is a reminder that improving the quality of care means moving beyond the common concepts of facilities providing basic or comprehensive emergency obstetric and newborn care at primary or hospital levels, and requires a shift in focus to the provider instead. human resources are the crucial factor underlying all approaches to care organisation. midwives and nurse-midwives should be at the centre of a country-led, adapted-to-context, resilient and fit-for-purpose redesign. we note that a cochrane review of trials in highincome countries of midwife-led continuity models of care with other models of care involving women suggests that women who received midwife-led continuity models of care compared with other models of care were less likely to have potentially harmful interventions such as episiotomies or instrumental births and more likely to have a spontaneous vaginal birth and increased satisfaction. women were less likely to experience preterm birth and were at a lower risk of losing their babies. the review identified no adverse effects compared with other models. countries such as india and bangladesh are changing from training skilled birth attendants towards scale-up of midwifery training. in addition, there is more to be learnt from the integrated maternity system that exists, for example, in the uk, netherlands, scandinavia, australia and new zealand. here midwives provide cost-effective maternity care in community and hospital settings. childbirth care is offered in a range of settings to healthy women (home, hospital and midwife unit including free-standing or alongside an obstetric unit) with good outcomes. it is important to note that the largest global study of outcomes by planned place of birth found a lower caesarean section rate in midwifery-led care systems compared with other settings an important finding in view of the debate on non-rational use of caesarean section. it is timely that is the year of the nurse and the midwife: nurses and midwives must have the opportunity to be heard and to lead the further agenda on maternal and newborn health. midwifery-led childbirth care services at an intermediate level of a district healthcare system, integrated into midwifery-based continuity of care, should be an alternative approach to shifting all births to a hospital. midwifery-led continuity-based systems with midwifery-led childbirth care for low-risk women should be rigorously tested in lmic settings. second, while we agree that many referral systems do not function, better communication and referral across the tiers of a health system must be central to a country-led, adapted-to-context, resilient and fit-forpurpose redesign. the examples which roder-dewan and colleagues provide to indicate how transport to a hospital may be improved, can also stimulate thinking on how referral between levels of a healthcare system may be improved. but whether transport starts at home or at a facility, past challenges will remain if there is too little emphasis on sustainable operational systems as reports on lack of fuel or driver suggest. roder-dewan and colleagues propose a hub-and-spoke system linking primary to hospital care. this is surprising: to our knowledge such systems already exist in most lmic settings, where district health systems include linked primary care facilities and hospitals, comprising exactly such a hub-and-spoke system. a country-led, adapted-to-context, resilient and fit-forpurpose redesign should strengthen these established systems, for women, children and men; cutting across all diseases and illnesses. many district health systems are based on more than two tiers, and any change in strategy needs to build on these more nuanced systems. this strength should be harnessed. district medical officers and local health planners, with their rich local knowledge and insight, should drive the decisions on how and where high-quality childbirth care may best be delivered in their systems. third, we question the assertion that 'recent expansions in infrastructure and roads have put hospitals within reach of most families'. this claim is based on analysis from six countries (haiti, kenya, malawi, namibia, nepal and tanzania) suggesting that over % of women live within a -hour journey time to a hospital providing emergency obstetric care. the analysis assumes ideal conditions, including that motorised transport would be readily available if needed, ignoring the problems of finding transport at night or longer travel times during the rainy season as the authors admit. a -hour journey time to childbirth care is unrealistic in many settings. moreover, this is not the norm in high-income settings. in germany, it is suggested that a hospital offering childbirth care should be within - min travel time. roder-dewan and colleagues also admit the need to establish more decentralised health centres with comprehensive emergency obstetric care services to reduce the journey time. in view of the population increase, particularly in africa, establishing more hospitals is a forwardlooking strategy for maternal and perinatal health and other health needs. however, hospitals are large longterm investments. in southern tanzania, it took years from laying the first bricks of new operating theatres within health centres to establish functioning services, and even then, not all operating theatres have the staff to provide continuous care. there are examples of non-governmental organisationsupported initiatives where functioning services were developed faster and made more consistently available. however, midwifery-led birthing facilities equipped with functioning ambulance able to make transfers to a hospital with caesarean section services may be a less bmj global health complex and more flexible approach; more responsive to the needs of women and their families. geographical information systems can help find a local balance between quality and accessibility. while expanding hospital services remains a long-term vision, operational and practical medium-term strengthening is needed to fix the present quality of care and operational problems. and women should have a say: midwifery-led continuity models may provide the highest satisfaction among women and their families with lowest maternal and perinatal morbidity and mortality. the covid- pandemic is critically disrupting access to hospital care throughout the world, and this prompts us to share another perspective: hospitals are typically overcrowded and beds in postnatal wards are often shared, making infection prevention and control even more challenging than ever. at present, women and families are avoiding hospitals, in fear of infection. private transport has been severely interrupted. creating resilient health systems means that quality care is also available in crisis. in cambodia, community-based research respondents raised the lack of flexibility of the provision of childbirth care when floods were disrupting normality. women and their families should not only be consulted as research respondents but continuously, so that end users are central to defining strategies. women and their families should have a say indicating how far is too far. in conclusion, although we concur with many of the arguments and conclusions, we believe that more discussion is needed and more options need to be rigorously tried and tested to develop sustainable district health systems which are fit for purpose and respond to needs of women, their babies, their families and centred around midwifery-based continuity of care. health system redesign for maternal and newborn survival: rethinking care models to 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on pregnancies from two cluster-randomised controlled trials midwife-led continuity models versus other models of care for childbearing women world health organization. maternal, newborn, child and adolescent health perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the birthplace in england national prospective cohort study maternal and perinatal outcomes by planned place of birth among women with low-risk pregnancies in high-income countries: a systematic review and meta-analysis we do what we can do to save a woman" health workers' perceptions of health facility readiness for management of postpartum haemorrhage in low-and middle-income countries, is delivery in high-quality obstetric facilities geographically feasible? welche geburtsklinik für welche schwangere? [which maternity hospital for which pregnant women? enhancing maternal and perinatal health in under-served remote areas in sub-saharan africa: a tanzanian model how can childbirth care for the rural poor be improved? a contribution from spatial modelling in rural tanzania staying afloat: community perspectives on health system resilience in the management of pregnancy and childbirth care during floods in cambodia key: cord- -dkk motm authors: ho, jing-mao; li, yao-tai; whitworth, katherine title: unequal discourses: problems of the current model of world health development date: - - journal: world dev doi: . /j.worlddev. . sha: doc_id: cord_uid: dkk motm the covid- pandemic has exposed institutional deficiencies in world health development. this viewpoint paper examines the allegations about the partiality and political bias of the world health organization’s (who) response to world health emergencies. we draw on quantitative and qualitative analysis of the who’s director-general’s speeches pertaining to the covid- and evd outbreaks. we find that the who’s discourse on covid- praised the chinese government’s role in the containment. by contrast, the who’s discourse on the african countries fighting to contain ebola centered on the unpreparedness of these countries. we argue that the who’s unbalanced emphasis on different practices and “traits” of member states paints a partial picture of global health emergencies, thus it fails to uphold its founding principles of egalitarianism and impartiality. finally, we put forward suggestions about a more equal and fairer model of world health development. the world health organization (who) has been regarded as playing an important role in advancing global health development (brown, cueto, & fee, ; magnusson, ; ruger & yach, ) , however it is no stranger to calls for institutional reform. following the who's handling of the outbreak of ebola virus disease (evd) in west africa numerous requests for its overhaul or even dissolution were made (checchi et al., ; kamradt-scott, ; negin & dhillon, ) . institutional deficiencies identified in the who, include amongst others (wenham, ) , that the functioning of the who is subject to international power struggles. the current model of global health development has been criticized for its imperialist tendency (levich, ) and the dominant role of state actors (adams, behague, caduff, löwy, & ortega, ; mcinnes et al., ) . indeed, the governing body of the who is made up of member states, while civil societies, such as professional associations, academic groups, and non-profit organizations, only play a very limited role (checchi et al., ) . this institutional structure opens the door for political manipulation, making the who vulnerable to the power game of international politics (kamradt-scott, ) . consequently, global health development is contingent upon power relations among the who's member states. sovereignty and national interests, for example, can confound attempts at transnational coordination, rulemaking, and adjudication (frenk & moon, ) . certain health programs or initiatives may be underfunded and underdeveloped because the countries affected lack the political or financial clout to mobilize support (adams et al., ; nunes, ) . thus, inequalities in global health development are perpetuated and exacerbated. a variety of proposals to address these deficiencies were unveiled by special commissions and panels. ideas in the proposals included splitting the who, revising its constitution, and establishing a new world organization that engages non-state actors (for a summary, see mackey, ) . after reviewing these suggestions, the who decided not to make major, structural changes (mackey, ) . unfortunately, the covid- pandemic has again exposed the who's institutional deficiencies. in early december , a ''cluster of pneumonia cases" was identified in wuhan, china, but official, public messages about this novel coronavirus were not released until december . despite the absence of independent scientific research, on january , the who announced that china had not found ''clear evidence of human-to-human transmission" of covid- . the director-general of the who, tedros adhanom ghebreyesus, also asserted there was no need to ''unnecessarily interfere with international travel and trade" nor implement travel bans on people from china. even as evidence https://doi.org/ . /j.worlddev. . - x/Ó elsevier ltd. all rights reserved. mounted that covid- was highly contagious, the who delayed declaring a global pandemic until march . ghebreyesus, for example, in late february claimed that covid- is not a pandemic and is not spreading in an uncontained way. to date, covid- has resulted in nearly million confirmed cases across the world, and more than thousand deaths worldwide. the who has been widely criticized for not acting impartially, for failing to coordinate an immediate international response, and for being too slow to sound the alarm. it is again facing demands for reform. we were particularly interested in these allegations of partiality and political bias because the who, as an independent international health agency, is expected to be immune from political pressure or intervention from any country and should present factbased evidence in an impartial way. impartiality (and the perception of it) can be achieved by maintaining consistency in decision making processes and offering balanced factual information regardless of who the stakeholders are. therefore, we decided to analyze the who's director-general's speeches pertaining to covid- ( documents from january to april ) and evd ( documents from august to september ), to test the credibility of the above assertions. we found the who constructed markedly different narratives of the countries identified as the source of these pathogens and appears to have engaged in a selective presentation of information. after quantitatively and qualitatively analyzing the who's official discourses on both covid- and evd, we found the official who narrative disproportionately focused on a single member state (china) (see fig. ) or group of member states (guinea, sierra leone, and liberia) (see fig. ). one may argue that frequent mentions of these states should be expected as ''factual background" considering the first cases of each pathogen originated there. however, examining the who's discourses carefully, we find that mentions of china in connection with covid- often highlighted china's positive contributions to controlling the pandemic. our results show that out of nonneutral references to china, not one was negative. by contrast, mentions of guinea, sierra leone and libera were more varied. out of non-neutral documents, of them contained negative references to the affected african nations highlighting poverty, poor facilities, political instability, and cultural traditions that facilitated the spread of evd. were neutral and described facts such as infection rates and deaths, while only of them were positive commending efforts to conduct contact tracing. turning to our qualitative analysis, similar to salzberger et al's ( ) findings, we find that the who emphasized china's successful containment of covid- . for example, on january , , the director-general claimed in his speech: as you know, i was in china just a few days ago, where i met with president xi jinping. i left in absolutely no doubt about china's commitment to transparency, and to protecting the world's people (emphasis added). the who repeatedly expressed its gratitude toward china's efforts of containing the spread. for example, at the munich security conference, ghebreyesus claimed that ''the steps china has taken to contain the outbreak at its source appear to have bought the world time" (february , ). bruce aylward, who led a who expert mission to china in february, defended who's narra-tives and said that china had ''worked very hard, very early on" to identify and detect early cases (april , ). however, the who's descriptions could be seen as inconsistent with the findings of previous research that suggest the chinese regime tends to withhold information about public health issues and could pose a threat to global health governance (brown & ladwig, ; chan et al., ; goldizen, ) . in contrast to the praise of china's efforts of containing covid- , the who's narrative of the west african nations affected by evd highlighted their poverty, political instability, and cultural traditions. for example, in , the then director-general of the who, margaret chan, in her address to the regional committee for africa, said ''[b]ecause ebola has historically been confined to poor african nations. the r&d incentive is virtually nonexistent. . .ebola, make africa's neglected health systems and impoverished populations highly visible" (emphasis added). in another official speech on august , , chan highlighted the affected african countries' inability to fight ebola by claiming ''guinea, liberia, and sierra leone have only recently returned to political stability following years of civil war and conflict, which left health systems largely destroyed or severely disabled. the outbreak . . . threatens to push these countries backwards (emphasis added). in addition to describing the affected african countries as incapable of dealing with the epidemic, the who claimed that the evd ''virus exploited west africa's deep-seated cultural traditions and some of them were the most dangerous because they proved highly resistant to change" (emphasis added) (march , ). more specifically, chan argued in the same speech: in liberia and sierra leone, where burial rites are reinforced by a number of secret societies, some mourners bathe in or anoint others with rinse water from the washing of corpses. . ..to this day, communities in guinea and sierra leone continue to hide patients in homes, conduct secret unsafe burials at night, and refuse to cooperate with contact tracing teams (emphasis added). the who seemed to attribute the failure of west africa's evd containment to intrinsic problems with those affected countries by arguing that ''[d]eep poverty, a disruptive political history, and centuries-old cultural beliefs and traditions created immense barriers to rapid containment" (november , ). such language may serve to reinforce the impoverished image of the affected african countries amidst ebola (jones, ; kapiriri & ross, ) . here it is not our intention to say that the who's praise of china undermines its impartiality (e.g., gilsinan, ) , nor do we wish to say that the who's acknowledgement of resourcebased and practice-based challenges faced by clinicians in west african nations is unfounded. rather, we wish to highlight that the who's positive narrative of china's role in the current pandemic and the negative narrative of the capacity of west african nations to contain evd created a partial (in both senses of the term) picture of the respective health crises. the praise of china may divert attention away from less favorable facts, including its role as the source of the pandemic and its initial attempts to restrict information about and reporting on the virus. similarly, the who's focus on the vulnerabilities of west african countries may draw attention and agency away from the work health practitioners did on decontamination, giving the dead dignified but safe burials, and contact tracing. these unbalanced accounts of nation states can open the who up to allegations of the selective, or biased presentation of information. these partial narratives may deepen pre-existing misperceptions and prejudices related to unequal global development held by the general public and international community (kapiriri & ross, ; leach et al., ) . we acknowledge that the analysis of media portrayal may produce different results, but this is not the focus of this study. the dramatic differences in the who's discourses on covid- and evd remind us that the world is not only divided by health disparities but also by the power plays of international politics. the who's unbalanced emphasis on different practices and ''traits" of member states allows us to see that it is not immune to taking on the biases found in international politics and as a consequence has failed to uphold the principles of egalitarianism and neutrality in global health governance upon which it is founded. if the who is to guarantee ''the happiness, harmonious relations and security of all peoples," international politics should not be a hinderance to the efforts to succeed in achieving that purpose (benatar, ) . thus it is again clear that institutional reform is needed to bring about a more equal and transparent system of global health development (lee & kamradt-scott, ; ruger, ) . we acknowledge that any international body responsible for health governance must recognize and address the inequalities in financial capacity and health outcomes found between the global north and south. however, it should not perpetuate such a divide ontologically through its narratives (sastry & lovari, ) . as the world's authority of health information sources, the who ought to prioritize the presentation of scientific facts rather than political rhetoric. factual information about a new disease or virus matters not only to public understanding but also to public health and policymaking. one way to avoid the dissemination of partial narratives would be increasing the space for and visibility of other actors and their narratives within and outside the organization. instead of over- whelmingly only focusing on its member state governments, the who can and should pay more attention to both local and international ngos that are usually in the front line dealing with public health emergencies, and their initiatives for and contributions to global health. concrete starting points in this vein might be to revisit the text of the who's framework of engagement with non-state actors and its membership criteria. our suggestions may be easier said than done, but should serve as a steppingstone along the way to a more sustainable and successful model of world health development. the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. re-imagining global health through social medicine counts of the top most frequently mentioned countries in the who's director-general's speeches on evd politics, power, poverty and global health: systems and frames the world health organization and the transition from ''international" to ''global" public health covid- , china, the world health organization, and the limits of international health diplomacy china engages global health governance: processes and dilemmas world health organization and emergency health: if not now governance challenges in global health april ). the atlantic: how china deceived the who from sars to avian influenza: the role of international factors in china's approach to infectious disease control ebola, emerging: the limitations of culturalist discourses in epidemiology who's to blame? the world health organization and the ebola outbreak in west africa the politics of disease epidemics: a comparative analysis of the sars, zika, and ebola outbreaks governing epidemics in an age of complexity: narratives, politics and pathways to sustainability the multiple meanings of global health governance: a call for conceptual clarity the gates foundation, ebola, and global health imperialism the ebola outbreak: catalyzing a ''shift" in global health governance non-communicable diseases and global health governance: enhancing global processes to improve health development the oxford handbook of global health politics outsourcing: how to reform who for the st century ebola and the production of neglect in global health ethics and governance of global health inequalities the global role of the world health organization successful containment of covid- : the who-report on the covid- outbreak in china communicating the ontological narrative of ebola: an emerging disease in the time of what we have learnt about the world health organization from the ebola outbreak key: cord- - a avlro authors: hou, tianya; zhang, taiquan; cai, wenpeng; song, xiangrui; chen, aibin; deng, guanghui; ni, chunyan title: social support and mental health among health care workers during coronavirus disease outbreak: a moderated mediation model date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: a avlro purposes: during the outbreak of coronavirus disease (covid- ) all over the world, the mental health conditions of health care workers are of great importance to ensure the efficiency of rescue operations. the current study examined the effect of social support on mental health of health care workers and its underlying mechanisms regarding the mediating role of resilience and moderating role of age during the epidemic. methods: social support rating scale (ssrs), connor-davidson resilience scale (cd-risc) and symptom checklist (scl- ) were administrated among health care workers from jiangsu province, china during the peak period of covid- outbreak. structural equation modeling (sem) was used to examine the mediation effect of resilience on the relation between social support and mental health, whereas moderated mediation analysis was performed by hayes process macro. results: the findings showed that resilience could partially mediate the effect of social support on mental health among health care workers. age group moderated the indirect relationship between social support and mental health via resilience. specifically, compared with younger health care workers, the association between resilience and mental health would be attenuated in the middle-aged workers. conclusions: the results add knowledge to previous literature by uncovering the underlying mechanisms between social support and mental health. the present study has profound implications for mental health services for health care workers during the peak period of covid- . a a a a a the coronavirus disease (covid- ) as an unprecedented threat has infected more than , , people by april, [ ] , which has attracted international attention as a public health emergency of international concern [ ] . considerable countries are confronting escalating pandemics and tremendous burden. the availability of skilled health care workers is the decisive factor in overcoming a viral epidemic [ ] . in the most affected areas such as hubei province, china where the confirmed cases were first reported, nearly all health care workers work directly with the infectious patients, whereas in the less affected areas, some health care workers directly fight against covid- and others are prepared to fight. however, the bravery of health care workers cannot protect them away from mental health problems during covid- . according to the research during the severe acute respiratory syndrome (sars) outbreak, health care workers have shown mental health problems with % hospital workers reporting higher levels of stress [ , ] . another study during ebola outbreak presented that health care workers of sierra leone had significant psychological symptoms including depression, interpersonal sensitivity and even paranoid ideation [ ] . more importantly, evidence from previous literature showed that the stress levels for high-and low-risk health care workers were equivalent during the outbreak of epidemic [ ] . psychological intervention and mental health services were in need to prevent health care workers from being traumatized as they were emotionally affected during the epidemic [ , ] . mental health is fundamental to an individual's overall well-being and absolutely essential to a productive and efficient life. in workplace, mental health problems are found to be associated with plenty of negative influences, such as reduction of efficiency, loss of productivity, disability and absenteeism [ , ] . given the adverse impacts, it is of great importance to investigate the potential factors and mechanisms that could enlighten the improvement of the mental health and maintenance of productivity of health care workers in the mist of the epidemic. among all the influential factors, social support has been recognized as one of the protective factors for mental health [ , ] . thus, the aim of the present study was to replicate the relationship between social support and mental health based on the health care workers during covid- outbreak, and further extend the previous studies by exploring the potential mechanisms in the relationship. social support is individuals' perception or experience in terms of being involved in a social group where people mutually support each other [ ] . previous research has repeatedly emphasized the role of social support in the promotion of mental health [ ] . not only crosssectional studies [ , ] , but also a large body of longitudinal studies emerging recently [ , ] have confirmed the positive association between social support and mental health outcome robustly. although a substantial number of research found this strong relation can hold across a broad range of samples, such as cancer patients, patients with multiple sclerosis, nurse students and so on [ , , ] , a handful of studies have presented different results. a meta-analysis conducted by ge, zhao, liu, zhou, guo & zhang [ ] has concluded that for the aged people, mental health was weakly or extremely weakly associated with social support. fiori et al. [ ] has claimed that the emotional support was only related to mental health in females only, not in males. therefore, it is vital to note the previous studies have found the relation between social support and mental health based on certain samples, however, whether the conclusion could be duplicated to health care workers during the outbreak of covid- still remains unexplored. moreover, the mediating mechanisms (i.e., how social support correlates with mental health?) and moderating mechanisms (i.e., when this relationship is most potent?) underlying the association between social support and mental health also stay largely unknown. answering these questions could be of vital importance to further understand the mental health of medical workers and advance the more effective interventions to ensure the productivity of health care worker during covid- . thus, the present research employed a sample of chinese health care workers during covid- outbreak to explore a conceptual model in which, on the one hand, resilience mediated the association between social support and mental health; on the other hand, the indirect relationships between social support and mental health via resilience were moderated by age group. social support and resilience. resilience is an individual's capacity to deal with significant adversity and quick recover [ ] . a great many of studies based on various methodologies and samples have provided robust evidence with respect to the association between social support and resilience. numerous cross-sectional studies have revealed a positive association between social support and resilience [ ] [ ] [ ] . in addition, a longitudinal study conducted by liu, he, jiang, & zhou [ ] utilized a sample of adolescents from . earthquake-hit region and confirmed social support as the protective factor of resilience after a one-year followup. furthermore, a meta-analysis including studies also has concluded that social support, particularly the utilization of the support, could enhance children's resilience [ ] . thus, it is possible that social supports could enhance the resilience of health care workers. resilience and mental health. mental health is the critical component of personal development and growth, which is more than the absence of mental illness [ ] . plenty of empirical studies reach the consensus that resilience exerts an positive effect on mental health [ ] [ ] [ ] and the association is presented to be consistent across different samples with diverse background [ ] [ ] [ ] . also, psychological resilience can help protect individuals against mental illness and thrive from the adversity [ ] . in fact, a few researchers have investigated the relation between social support, resilience and wellbeing [ , , , ] . it is worth noting although the previous studies explored the relation, some treated resilience as a covariate or moderator, while others did analyze resilience as a mediator. however, as far as we know, no research has examined whether the relationship between social support and mental health via social support could be applied to the health care workers who are prepared and fight during the epidemic. although social support may have an impact on mental health indirectly via resilience, not all people with lower resilience suffer from lower level of mental health. therefore, it is essential to explore the influential factors that could strengthen or attenuate the link between social support, resilience and mental health. this research examined a hypothesis that the resiliencemental health link in the indirect association between social support and mental health would be moderated by age group. several studies have concluded the possibility of the receipt of depression treatment diminished as getting older [ , ] . robb, haley, becker, polivka & chwa [ ] have compared the similarity and difference between younger and older adults in the attitudes towards mental health service, and found younger adults showed more willing to seek mental health services compared with the elder. in addition, dinapoli, cully, wayde, sansgiry, yu, & kunik [ ] have examined the role of age in the prediction of mental health service use. the results have presented that younger adults with depression or anxiety disorders were more likely to utilize mental health service compared with the middle-aged adults. the mental health services include mediation, yoga and stress management, which are mainly focusing on the enhancement of resilience [ , ] . in sum, younger adults might be more likely to receive resilience training to improve the mental health than middle-aged adults. thus, the mental health of younger adults might rely more on resilience than other factors. furthermore, health care workers during the pandemic are in highly psychological stressing condition when fighting against covid- outbreak [ ] . the middle-aged workers usually have longer length of employment and more working experience than the younger workers. meanwhile, the odds of participation in the fight against other epidemics before might be higher for the middle-aged in comparison to the younger. all these past experiences would make them less stressful, less anxious, less fearful and better mental health state when facing the epidemic [ ] . taken all together, the mental health of the middle-aged workers would be less dependent on resilience, which indicates the link between resilience and mental health would be attenuated in middleaged adults than younger adults. in fact, a meta-analysis including studies has specifically investigated the moderating role of age in the relation between trait resilience and mental health [ ] . however, the study just concluded the relation was stronger for adults than children and adolescence, without the comparison between younger adults and middle-aged adults. unlike the previous research, the current study examined the potential difference between the younger and middle-aged medical workers in the link between resilience and mental health. taken all together, the aims of this research were twofold: (a) to examine whether the mediating role of resilience in social support and mental health could be duplicated to the health care workers from a less affected area during the covid- epidemic, and (b) to test whether the relationship between social support and mental health via resilience is moderated by age group. the current study constructed a conceptual model to address both mediation and moderation effects (see fig ) . based on the literature review, the following hypotheses were proposed: hypothesis : resilience would mediated the relationship between social support and mental health of health care workers during covid- pandemic. hypothesis : age group would moderate the indirect association between social support and mental health via resilience such that the resilience-mental health pathway would be stronger in younger age group in comparison with the middle-age group. given that we suppose age would only moderate the second stage of the mediation path, the present study would call it "a second stage moderation model". the cross-sectional study was conducted from st to th february, , which was the peak period of covid- outbreak in china. the participants were health care workers from local hospitals, community health service centers and government department in jiangsu province who participated in the fight against covid- . the questionnaires were distributed through internet. all subjects were given informed written consent before completing the online survey concerning demographic information, social support, resilience and mental health. all the subjects were free to withdraw from the research at any time. the research was approved by the ethics committees of the second military medical university. a total of health care workers completed the survey in the present study. considering the present study was to compare the indirect effect of social support on mental health via resilience between the young and middle-aged heath care workers, participants aged or over were excluded. finally, subjects were included in the analysis. social support. the social support rating scale (ssrs) developed by xiao was utilized to measure social support [ ] . the -item scale consists of dimensions including objective support, subjective support and availability. a representative item was "how many close friends do you have to get support and help?". higher scores indicate higher levels of social support. the scale has presented impressive validity and reliability in chinese population [ ] . the cronbach's alpha for the present study was . . resilience. the connor-davidson resilience scale (cd-risc) was used to assess resilience [ ] . the -item likert scale consists of five dimensions: (a) personal competence, high standards, and tenacity; (b) trust in one's instincts, tolerance of negative affect, and strengthening effects of stress; (c) positive acceptance of change and secure relationships; (d) control; (e) spiritual influence [ , ] . participants rated each item from (not true at all) to (true all the time). the range of total scores is from to , with higher scores representing higher levels of resilience. the scale has presented good psychometric properties [ ] . in this study, the cronbach's alpha was . . mental health. symptom checklist (scl- ) developed by derogatis and cleary [ ] was administrated to evaluate mental health [ , ] . the -item scale is widely applied to measure clinical psychiatric symptoms and differentiate individuals with mental illness from healthy people [ , ] . each item is rated from (no symptom) to (severe symptom). the higher total scores the participants got, the worse mental health condition they were in. in this research, scl- � was defined as psychological abnormality [ ] . the scale has shown good validity and reliability in chinese population [ ] . in this research, the cronbach's alpha was . . firstly, the present study calculated the descriptive statistics and bivariate correlations among variables of interest by statistical package for social science (spss) . for windows. a twotailed p-value smaller than . indicated the presence of statistical significance. secondly, structural equation modeling (sem) conducted by amos . through maximum likelihood method was performed to examine the mediating role of resilience in the relation between social support and mental health. the model fit index included root mean square error of approximation (rmsea), standardized root mean square residual (srmr), goodness of fit index (gfi) and comparative fit index (cfi). as recommended by previous literature, the values of rmsea and srmr smaller than . and the values of gfi and cfi more than . indicate an acceptable fit [ ] . bias-corrected bootstrap method was used to examine the significance of mediation effect. specifically, we used bootstrap samples and determined the bias-corrected % confidence interval. if the confidence does not contain zero, it means the significance of the effects [ ] . finally, the moderated mediation model was tested by using hayes [ ] process macro (model ). the % bias-corrected confidence interval from resamples was generated by bias-corrected bootstrapping method to examine the significance of moderated mediation effect. the sociodemographic characteristics of the participants and the distribution of scl- scores were presented in table . most health care workers were females ( . %), middle-aged ( . %), married ( . ), and reported - years of schooling ( . ) and less than years of working ( . ). the prevalence of psychological abnormality was % among health care workers. the mean ± sd total score of scl- was . ± . . there were no significant differences in scl- scores associated with gender, age, marital status, years of schooling and years of working. social support was positively correlated with resilience and age group, and negatively correlated with scl- scores (all p < . ). resilience was positively associated with age groups and negatively associated with scl- scores (all p < . ). structural equation model was employed to examine the mediating role of resilience. firstly, the direct path coefficient from social support to scl- scores in the absence of resilience was significant, γ = - . , p < . . secondly, the structural equation model regarding the ) . a bootstrap procedure conducted to examine the mediation effects. bootstrapping samples was generated from the original dataset (n = ) via random sampling. the indirect effect of social support on scl- scores through resilience was - . (se = . , %ci = [- . , - . ], p = . ). the % biased-corrected confidence interval did not contain zero, which verified the indirect relationship between social support and scl- scores via resilience. it has been expected that age group would moderate the second stage of the mediation process. as shown in table , in model , social support positively predicted resilience, β = . , p < . . model revealed that the effects of resilience on scl- scores was moderated by age group, β = . , p < . . for descriptive purpose, the present study plotted the relationship between resilience and scl- scores, separately for younger and middle-aged groups (see fig ) . simple slope test presented that for subjects from younger group, resilience was significantly and negatively associated with scl- scores, β simple = - . , p < . . for subjects from middle-aged group, resilience was still negatively correlated with scl- scores, but much weaker, β simple = - . , p < . . the biased-corrected % confidence interval for index of moderated mediation was from . to . , which did not contain zero. this further presented that the indirect effects of social support on scl- scores via resilience significantly differed between groups. evidence from previous literature has already found health care workers with higher levels of social support are more likely to show higher levels of mental health [ , ] . nevertheless, issues regarding the underlying mediating and moderating mechanisms and whether this could be applied to health care workers who are fighting with the outbreak of covid- stay largely unanswered. to our knowledge, the present study is the first to report the effect of social support on mental health based on health care workers from a less affected area during covid- outbreak. this research built a moderated mediation model to test whether resilience mediated the association between social support and mental health of health care workers and whether this indirect relationship was moderated by age groups. the results showed that ( ) the mediating role of resilience in the association between social support and mental health could be replicated to the health care workers during the epidemic; ( ) age moderated the indirect link between social support and mental health (resilience-mental health path), with younger workers showing stronger than middle-aged workers. the prevalence of psychological abnormality was % among health care workers in our study, lower than that ( . %) of chinese health care workers during the sars epidemic [ ] . a recent study presented the rate of mental abnormality among nurses in guangdong province was . % during the non-epidemic phase [ ] . the difference might be attributed to the fact that jiangsu province was less affected during the covid- pandemic. additionally, different instruments and regional differences might also contribute to the discrepancy. generally speaking, the prevalence of psychological abnormality cannot be neglected and more attention should be paid to address this issue. in line with our hypothesis, resilience mediates the relationship between social support and mental health of health care workers during the epidemic. this is aligned with previous research based on different samples [ , ] . this study is the first to explore the relation with the focus on the population who are facing the emergency events of the public health. this finding can be explained by the "buffer" hypothesis developed by cohen and wills [ ] , which revealed the buffering effect of social support on the impact of stress upon mental health. the previous research has highlighted that finding effective approaches to deal with stress is of great importance in positive health outcomes [ ] . social support could protect individual from stressful conditions and poor health state [ ] . meanwhile, individuals with higher levels of social support might be more inclined to believe that they could get the help needed when facing the stressful event regarding the outbreak of the epidemic. this notion would enhance their beliefs to deal with the adversity and difficulty in the battle with covid- , which further leads to the higher levels of resilience [ ] . in addition, the reports of previous literature have demonstrated that resilience, as one kind of personal resources, also buffered the impact of stress on mental health [ ] [ ] [ ] [ ] . taken all together, resilience plays a mediating role in the association between social support and mental health for the health care workers fighting with the epidemic. the findings also revealed the moderating role of age groups in the association between resilience and mental health of the health care workers. in the past research, a small handful of previous studies have found that age moderated the link between resilience and mental health by the comparison between younger adults and older adults (usually age and over) [ , ] , whereas some other researchers focused on the contrast between the adults and minors [ ] . however, these studies neglected the potential differences between the younger adults and middle-aged adults. unlike the past research, this study took the potential difference between younger and middle-aged health care workers into consideration innovatively. consistent with our hypothesis aforementioned, the increase in age (from young adults to middle-aged adults) attenuated the relationship between resilience and mental health. specifically, the younger health care workers showed stronger association between resilience and mental health compared to the middle-aged ones. this result might be interpreted by erikson's theory of life cycle development [ ] , which postulates eight stages of human life. younger adults belong to stage vi with the emphasis on intimacy, while middle-aged adults are attributed to stage vii focusing on generativity. erikson's generativity stage is similar to self-actualization in maslow's hierarchy of needs [ , ] . hence, compared with younger adults, the mental health of middle-aged adults relies less on resilience but other factors, such as the feeling of self-fulfillment, personal growth and so on. the findings of this research have profound implications since the data were collected during the peak period of covid- in china, which is the stage other countries are currently experiencing. first, the results stress the crucial role of social support in mental health. during the outbreak, the maintenance of mental health of health care workers is crucial for the productivity and work efficiency. therefore, it is of great importance to provide a full range of social support including instrumental support, emotional support and so on. second, the findings also highlight the potential value of resilience-focused intervention in health care workers. the resilience-focused mental health promotion program usually contains coping skills, stress management, positive attitude and so on [ ] . finally, the indirect link between social support and mental health via resilience is stronger in younger adults, which implies we should give priority to younger health care workers with respect to resilience-boosting intervention. meanwhile, we also need to find other influential factors of mental health for middle-aged health care workers. several study limitations must be noted. first, the current study employed a cross-sectional design since health care workers who have consecutively worked for several days would be replaced by others, which made it hard to revisit them after a certain period. however, the cross-sectional design is insufficient to infer the causality in terms of the relationship analyzed. also, as existing literature showed, social support and resilience might influence each other reciprocally [ , ] , the reverse causality cannot be ruled out. future research could conduct longitudinal study to further explore the moderated mediation model. second, the study used convenient sampling and all data were collected through self-report, which undermined the generalization of the results. the participants in our study were all from jiangsu province, china, which was geographically limited for a wider generalization. future research could test the relation based on more typical samples from multiple regions and manage to collect data from multiple sources (e.g., colleagues). finally, mental health is a complex concept, which could be influenced by numerous factors. social support and resilience could just explain a limited part of mental health. sleep quality and fatigue might be two important factors of mental health, but we failed to investigate. during the covid- outbreak, health care workers had to work excessive hours and suffered from disrupted circadian rhythms, which would contribute to fatigue and undermine sleep quality. hence, future study might focus on a more integrated model of mental health with diverse influential factors. in spite of the limitations, the current study contributes to the previous literature theoretically and practically. theoretically, this study adds knowledge to the previous research by exploring the moderated mediation model, which would help further understand the relationship between social support and mental health. practically, the findings are essential for the maintenance of mental health of health care workers during the outbreak of covid- . in conclusion, this study presented the protective role of social support in mental health among health care workers. moreover, resilience could be one of the pathways through which social support contributes to mental health. furthermore, the effect of social support on mental health via resilience is attenuated in middle-aged health care worker compared with the younger ones. supporting information s file. (sav) s data. strobe statement-checklist of items that should be included in reports of cross-sectional studies. 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buffering hypothesis social support and risk for cardiovascular disease and cancer: a qualitative review examining the role of inflammatory processes multiple identities and psychological well-being: a reformulation and test of the social isolation hypothesis the buffering effect of resilience on depression among individuals with spinal cord injury: a structural equation model work related stress, social support, and engagement as predictors of resilience in emergency department nurses the mediating effect of resilience between mental stress and mental health on college students buffering effect of coping style on the stress-depression relationship among taiwanese icu nurses: a multi-group structural equation model with two-factor nurse stress checklist psychological resilience in young and older adults age differences in the association of social support and mental health in male u.s. veterans: results from the national health and resilience in veterans study childhood and society motivation and personality generativity versus stagnation: an elaboration of erikson's adult stage of human development systematic review of resilience-enhancing, universal, primary school-based mental health promotion programs the influence of the resilience on the organizational commitment of kindergarten and childcare teachers: social support as a mediating variable the authors would like to acknowledge all participants and the research assistants from naval medical university. key: cord- - f ksxi authors: smith, david barton title: the pandemic challenge: end separate and unequal healthcare date: - - journal: am j med sci doi: . /j.amjms. . . sha: doc_id: cord_uid: f ksxi nan viruses don't care about income, wealth, insurance status or color lines. universal health care protects everyone by assuring that no one is blocked from getting care because of unaffordable out of pocket costs. as the only developed nation that has failed to provide such protection and where a growing population of . million are uninsured and roughly an equal number have inadequate coverage that still makes essential care unaffordable, we face greater risks. fifty-one percent of the un-insured population are either african american or hispanic. the uninsured are more likely to delay testing and treatment. amid the covid- pandemic, this exposes everyone-insured, uninsured, rich, poor and all racial and ethnic categories to greater risks. proposals to address this vulnerability have been dead on arrival since before the last deadly pandemic swept across this country in . the reason for the deaths of these proposals is so embedded into the structure of our existing health system that it tends to be overlooked. it is a way of thinking about the organization and financing of health care that evolved in the wake of the plessy v. ferguson supreme court "separate but equal" decision in that justified segregating services by race and privilege. , , jim crow laws in the south, residential segregation laws in the north and patterns of medical practice that evolved adapting to these conditions shaped the development of our modern health system. , while the brown v. board of education supreme court decision rejected the "separate but equal" argument, an accumulation of even less plausible euphemisms as strategies for preserving the segregated status quo left the health system largely unchanged. special interests stalled five major universal care initiatives over the past century invoking racially coded messages to gain broader public support. i summarize some of the details related to these efforts in a table and will focus here on how thinly veiled racially in the shadow of plessy, lodges and fraternal orders tried to take care of those who shared common racial and ethnic identities. the american association of labor legislation (aall) during world war i sponsored state legislation to provide health care to industrial workers supported by matching funds from the state, the employers and the employees that had the muted support of organized medicine's national leadership. lodges had already begun providing such protection for their members and objected. they contracted with physicians to provide care for their members for a fixed amount per year. despite the opposition of local medical societies, this approach to assuring access to care grew rapidly and many assumed it was the way most care would be financed in the future. they saw no reason to undermine their influence in recruiting new members by substituting "compulsory governmental paternalism for private voluntary fraternalism." it was also easy to appeal to the broader aversion to racial and ethnic mixing that state legislation implied. "volunteerism," is the th century notion that charity could better be handled by private philanthropic efforts than government. the interests of hospitals and medical societies were protected by producer cooperative "voluntary" pre-payment arrangements (blue cross and blue shield plans). these arrangements also helped end what organized medicine regarded as the "evils" of lodge medicine. while it could never cover those most in need of protection, it still offered as an illusory alternative to what was portrayed as the unpalatable "compulsorygovernment sponsored-socialistic" social security proposals of the roosevelt and truman administration. it also helped perpetuate segregation by delegating the care of those not eligible for employer-based insurance to the local indigent care system. the roosevelt-truman proposals never had a chance. the brown decision and the efforts of the civil rights movement, however, helped propel the passage of the medicare and medicaid legislation in . hospital accommodations were desegregated using the leverage of this new federal funding to overcome the "freedom of choice" defense of the segregationists. if hospitals remained segregated, they argued, it was because people should always have the "freedom of choice." federal officials rejected this argument and insisted on full integration of accommodations. however, that insistence generated a backlash that stalled expansion of this coverage to the rest of the population and partially re-segregated care. attention shifted, partly as an excuse for not expanding coverage to controlling rising costs. payment methods changed to "control" those costs (e.g. drg hospital payments and hmo capitated payments to group practices). while neither succeeded in stemming cost increases, they did succeed in partially re-segregating care. state medicaid programs became dominated by medicaid only hmo plans and drgs shifted much of the care that had been provided in acute hospitals back into more segregated communities. the clinton health security act of , relying heavily on hmo contracting in the face of rising opposition to such arrangements from those with private insurance never had a chance. steps in expanding coverage subsequently followed the lead of conservative think tanks, expanding coverage but privatizing it. this did little to control costs but the more fragmented "free market" approach helped insulate the health system from civil rights challenges. the affordable care act followed the privatization blueprint and succeeded in expanding coverage. however, since the democrats and our first black president served as sponsors of the legislation it was now racially coded as "obama care" and has faced unrelenting political and legal challenges from the right. it did nothing to alter the existing fragmented insurance system and its future survival is uncertain. we are, in the face of the current pandemic, all in it together. no one disputes that the health of any individual depends on the heath of everyone. perhaps this can lead organized medicine, a century long laggard in promoting universal care, to finally question the hollow rhetoric that has supported the status quo of jim crow healthcare. something as simple as just a uniform payment structure would not just cut costs but help end the tiered segregated system of care that persists. perhaps we can finally put an end to jim crow. key facts about the uninsured population kaiser family foundation national health insurance in the united states and canada: race, territory and the roots of difference the color of welfare: how racism undermined the war on poverty dead on arrival: the politics of health in twentieth century america the strange career of jim crow the color of law: a forgotten history of how government segregated america almost persuaded: american physicians and compulsory health insurance from mutual aid to the welfare state: fraternal societies and social services harry truman versus the medical lobby. columbia: university of missouri press the power to heal: civil rights, medicare and the struggle to transform america's health system the affordable care act at years-its coverage and access provisions key: cord- -agzb aac authors: montgomery, joel m.; woolverton, abbey; hedges, sarah; pitts, dana; alexander, jessica; ijaz, kashef; angulo, fred; dowell, scott; katz, rebecca; henao, olga title: ten years of global disease detection and counting: program accomplishments and lessons learned in building global health security date: - - journal: bmc public health doi: . /s - - - sha: doc_id: cord_uid: agzb aac nan worldwide, infectious diseases continue to emerge at an alarming pace, due to numerous factors including microbial adaptation, increasing human population migration, urbanization, conflict and instability, intensified animal-human interface, and habitat perturbation [ ] [ ] [ ] [ ] [ ] [ ] . the litmus test for an effective national public health program is its ability to be ready to initiate an effective response for an unknown emerging or re-emerging infectious disease or public health event. the most impactful global health programs are built with the understanding that they must be able to help countries strengthen core public health capacity so that new threats can be detected and contained before they become international crises that increase morbidity and mortality, adversely impact the health and livelihoods of individuals and populations, disrupt travel, interfere with global trade and economies, or even lead to political destabilization [ , ] . this is the basis for all global health security work and has been the mission of cdc's global disease detection (gdd) program since its inception in . as one of the first steps through which cdc systematically approached global health security, the gdd program was designed to bring resources together to promote a broader approach to preparing countries for any infectious disease threat that could occur [ ] . today, after more than a decade of partnerships in groundbreaking science, disease detection, and response to the world's most urgent public health threats, lessons from the gdd program as a precursor to global health security offer the global health community one model for collective success. this supplement is dedicated to highlighting a sample of successes achieved and lessons learned through the gdd program throughout its + years of implementation. the idea for the gdd program took shape against the backdrop of the - severe acute respiratory syndrome (sars) epidemic, which affected more than people in countries and cost the world more than $ billion us dollars [ , ] . in , the u.s. congress authorized funding for cdc to establish the gdd program [ ] . using existing research infrastructure developed as part of cdc's international emerging infectious diseases program, the gdd program was developed to "promote global health security by building capacity to rapidly detect and contain emerging health threats [ , , ] . since its inception, the gdd program has held a broader more cross -cutting mandate than previous cdc programs. rather than focusing on a single disease or issue, the gdd program helps prepare countries for any emerging or reemerging infectious disease outbreak or significant public health event. to fulfill its mission, the gdd program uniquely established a network of regional centers (gdd rcs) to help countries rapidly and effectively address public health threats. these international centers formed a worldwide base of health security through scientific evidence-based capacity building and creating strong, trusted ties with partner countries (fig. ) . the mandates of the gdd rcs were to help develop a strong workforce of epidemiologists and laboratorians; enhance or promote the one health concept [ ] by encouraging multi-sectoral collaborations between ministries of health and ministries of agriculture; and build and expand state-of-the-art laboratory capacity for detection of newly emerging infectious diseases in addition to strengthening basic laboratory diagnostic capabilities. to date, gdd rcs have provided expert consultations, supported outbreak response, and offered epidemiology and laboratory training in more than countries. ten gdd rcs existed (fig. ) as of january , representing the americas, africa, and asiaincluding the indian subcontinent and southeast asia. selection of countries for placement of gdd rcs was based on a number of factors, including: ) country interest in hosting a gdd rc, including track-record of previous successful collaborations with us government agencies ) high burden or perceived high burden of infectious diseases in the country or region, ) potential for infectious disease emergence, and ) a need to strengthen or improve public health infrastructure to detect and respond to infectious disease outbreaks. an early insight was that the baseline public health infrastructure varied from country to country. at a minimum, all were in need of workforce development (i.e. trained field epidemiologists, public health laboratorians, data analysts and health communicators), improvements in the ability to develop complex laboratory diagnostics, and creation or improvement of disease surveillance, including specimen transport systems and integration of laboratory and surveillance data into an adequate response system [ ] . to meet this variety of needs, cdc placed experienced medical epidemiologists, laboratorians, veterinarians, and public health specialists in a number of the gdd rcs [ ] . the work of the gdd rcs has been guided by two overarching objectives or principles: ) to conduct cutting edge public health science, including original research, and to generate solid data to inform public health policy decisions, and help guide public health capacity building, and ) to have forward-deployed assets or pre-positioned staff, equipment and supplies to map of gdd regional centers (gdd rcs) and outbreak support provided by the gdd rcs from to . color corresponds to the gdd rc that provided support, while size corresponds to the number of outbreaks supported in each country. note: outbreaks responded to in the home country of each gdd rc were not included in this map rapidly support the host country government's ability to respond to outbreaks and prevent further spread of disease within and outside the borders of the country. global health preparedness is a priority worldwide, as evidenced by the adoption of the international health regulations (ihr) in , and the subsequent work of over nations, the u.s. government, cdc, the world health organization (who), to advance the global health security agenda (ghsa) [ ] . ghsa, launched in february , is a commitment between countries to marshal resources, expertise, and technical assistance to build core public health infrastructure around the world and monitor progress using specific metrics and targets. the ultimate goal of the ghsa is to better prepare for epidemics and pandemics and to help countries meet their commitments to the who ihr, [ ] and the world organization of animal health's (oie) performance of veterinary services pathway [ ] . the gdd program's value in helping countries achieve ihr goals was solidified in december , when the programalthough a relatively small program with a modest budget was designated by who as a collaborating center for implementation of ihr national surveillance and response capacity [ ] . the gdd program contributes to global health security efforts in much the same way as ghsa by strengthening the world's core public health capacity, ultimately helping countries achieve ihr compliance. the program serves the countries in which it resides, as well as neighboring countries, with the expertise and support needed to prevent, detect, and respond to any public health threat. a look at the data: gdd program activities and accomplishments the gdd program has collected data for both quantitative and qualitative indicators to monitor and evaluate the progress and effectiveness of its regional centers since , with some additional indicators added in and . these indicators cover multiple topic areas including consultations, outbreak investigations, trainings and workforce development, pathogen discovery, new diagnostic testing capacity, surveillance, networking, and publications. data associated with each gdd rc capture both efforts and outcomes in country and support to other nations. additional cdc datasets with information on human assets deployed during the ebola epidemic and data sharing during the zika epidemic were also included in these analyses. the three datasets (gdd program indicators [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , ebola, and zika) were analyzed using tableau software, version . . . findings were validated with targeted outreach to cdc personnel. from to , gdd rcs responded to outbreaks around the world. each outbreak response corresponded to a specific event regardless of the number of cases identified during the outbreakfor example, a single case of rabies and an outbreak of dengue resulting in cases were both considered single outbreak events. outbreaks also included events in animals, such as h n in poultry, west nile virus in horses, and rabies in dogs, as well as responses related to the environment such as pesticide poisonings and natural disasters. one quarter ( of ) of all outbreaks that gdd rcs responded to between and occurred outside of the gdd rcs' countries of origin (fig. ) . among one of the most important contributions of the gdd rcs have been responses during the recent who-declared public health events of international concern (pheics). shortly after the april declaration of h n as a pheic, gdd rcs in egypt, guatemala, kazakhstan, kenya, and thailand partnered with countries to improve and/or establish diagnostic laboratory capacity to detect h n (fig. ) ; of these ( %) partnerships or interactions occurred from may -june , . during the - ebola outbreak in west africa, all gdd rcs, as well as cdc headquarters in atlanta, deployed gdd program personnel to aid in the response effort (fig. ). in total, individuals associated and stationed within the gdd rcs were among the first responders to be deployed; of these individuals deployed to liberia, guinea, and sierra leone, while others deployed to the republic of congo, guinea-bissau, drc, nigeria, benin, and switzerland. in addition, of the ( %) individuals deployed were host country nationals or locally employed staff. gdd rcs not only directly supported ebola response efforts but also prepared their respective and neighboring countries for possible importation and spread of the virus within their borders. using an assessment tool developed by cdc, gdd guatemala conducted an ebola preparedness assessment for latin american nations, while gdd egypt trained participants from jordan, morocco, lebanon, tunisia, and egypt on ebola preparedness. gdd bangladesh collaborated with a large number of non-governmental private sector groups to develop standard operating procedures for ebola case management and response; similarly, gdd thailand collaborated with health ministers from countries to develop a strategic framework for enhancing partnership on ebola preparedness and response. laboratory testing capacity for ebola was increased by gdd india, and airport screening protocols and border security were improved by gdd kenya. meanwhile, gdd rcs in south africa and china focused on increasing communication platforms for the dissemination of information concerning ebola. furthermore, the chinese field epidemiology training program (fetp) deployed current and former trainees for the first time and u.s. cdc locally engaged country staff were deployed to sierra leone to help transfer laboratory technology to the chinese laboratory in-country. the gdd rcs were well poised to act during the - zika epidemic. using a combination of funding sources, including zika supplemental funding provided through partnership with the us agency for international development and gdd core funding, eight of the gdd rcs (guatemala, kenya, thailand, south africa, india, bangladesh, china, and egypt) were able to use their existing acute febrile illness surveillance systems to implement a global, network-wide surveillance activity to examine the global distribution of zika virus. the timely introduction of zika testing into existing gdd supported surveillance platforms allowed for the rapid identification and characterization of some of the first zika cases in guatemala and india [ ] . the guatemala, kenya, and thailand rcs were also able to quickly design and implement studies to examine the effect of zika virus infection in pregnant women and their babies, and the guatemala rc was able to initiate activities to examine potential long-term outcomes of infection. leveraging existing platforms allowed for faster implementation of activities. it also generated important lessons for future responses, such as the need to map showing the deployment of regional center staff to countries in west africa and geneva, switzerland from cdc's regional centers around the world and from cdc's headquarters in atlanta, ga in response to the ebola epidemic. note: map does not include multiple deployments consider how differences among protocols can affect comparability of results across countries, and highlighted the potential benefits of centralized coordination of surveillance and research. one of the strengths of the gdd rcs has been their ability to increase laboratory capacity for identification of threats, including identifying new pathogens to the world or pathogens new to a region. of the outbreak responses, the gdd rcs provided laboratory support in ( %). of these laboratory-supported outbreak responses, ( %) resulted in a confirmed etiology or cause of the outbreak. in the same -year period, pathogen-specific tests were newly established or updated by gdd rcs in countries through a program of deliberate technology transfer. examples included tests for pathogens of international concern or pandemic potential (e.g. h n , h n , h n , mers coronavirus, chikungunya, and ebola), respiratory pathogens (e.g. adenovirus, rhinovirus, coronavirus, and rsv), acute febrile illness pathogens (e.g. q fever/coxiella burnetii, leptospirosis, brucella, rickettsia, and west nile virus), food and waterborne pathogens (e.g. escherichia coli, salmonella, shigella, listeria, and campylobacter), and others (e.g. bartonella species, botulinum neurotoxins, arboviruses, arenaviruses). in collaboration with local and international partners, gdd rcs conducted groundbreaking work on organisms during - , including detecting organisms new to their respective regions, discovering organisms and pathogens new to the world, and identifying pathogens with a new mode of transmission ( [ , ] , and bacterial and parasitic pathogens (q fever/coxiella burnetii, leishmania species, and legionella longbeacheae) [ ] . in , the gdd program began collecting data on the number and type of surveillance platforms and the number of people enrolled or captured in active or passive disease surveillance systems. gdd rcs' activities currently cover more than , , people through various types of surveillance platforms. gdd rcs have established more than unique surveillance sites monitoring disease syndromes and specific illnesses such as acute febrile illness, respiratory disease, japanese encephalitis, and nipah virus. the syndrome most commonly responded to by gdd rcs from to was gastrointestinal illness (diarrhea, vomiting), followed by influenza-like illness (ili) and acute/undifferentiated febrile illness (a/ufi). increased ili cases in were due to the pandemic of h n and outbreaks of h n , while increased gastrointestinal illnesses in corresponded to cases of cholera in kenya, and increased a/ ufi in correlated with the dengue and chikungunya outbreaks in east africa. the types of disease surveillance platforms implemented via the gdd rcs include event-based, sentinel, facility-based, and population-based surveillance. the ability to conduct population-based surveillance is particularly important because it often provides the most accurate information on the burden of infectious disease syndromes, as it allows for the calculation of their incidence, which is the number of cases among a known population size during a standard period of time. gdd rcs in china, egypt, guatemala, india, kenya and thailand have conducted population-based surveillance over the course of the -year period [ ] [ ] [ ] [ ] [ ] [ ] . the incidence rates generated via these platforms are important measures of disease burden because they can be compared across different locales. examples of uses of data derived from population-based surveillance include the comparison of rates of disease in rural areas with rates in urban areas and the monitoring of impact of interventions or control strategies. the gdd program recognizes that a strong workforce lies at the core of effective emergency response. from to , the gdd rcs trained more than , multi-disciplinary public health professionals through unique training sessions. the subject matter experts from across cdc headquarters, as well as highly trained medical epidemiologists, laboratorians, veterinarians, and public health specialists stationed within the gdd rcs lead formal training programs, such as the field epidemiology training program (fetp), offer informal on-the-job-training and provide mentorship to local counterparts [ ] . in addition to leading training opportunities such as tabletop exercises and data analysis workshops, gdd rcs capitalize on cdc subject matter expertise around the agency to provide disease-specific guidance and training. this development of workforce capacity at the local level is integral to identifying and containing public health threats at their source. the graduates of fetps in gdd rcs from to responded to many of the outbreaks recorded, leading to proper identification of the source for many of the outbreaks, detection of additional cases/determining the full scope of the outbreaks, and classification or discovery of existing or novel risk factors of disease transmission. more often than not, these graduates continue to practice public health in-country after graduating [ ] . gdd rcs served as the platform for subject matter experts and researchers across cdc and through their effort provided a total of public health consultations from to . consultations varied widely in scope, type of collaborators, and length of partnership. for example, gdd kenya regularly provided consultations on health issues affecting refugees in kenya, ethiopia, uganda, and tanzania, while gdd india teamed up with the national institute of mental health and allied sciences (nimhans) to work on an acute encephalitis syndrome network. regional centers such as gdd egypt, gdd kazakhstan, and gdd georgia conducted laboratory assessments at laboratories and hospitals, recommended laboratory equipment for national blood banks, and advised on infection control procedures, respectively, with subject matter expertise support from cdc headquarters. furthermore, the gdd rcs supported the use of technology by collaborating with provincial satellite tv channels to communicate risks such as hand, foot, and mouth disease (hfmd) and h n in vietnamas was the case with gdd chinaand by providing technical support for an electronic surveillance platform in panama, coordinated out of the gdd rc in guatemala. finally, gdd rcs worked with a number of collaborators (i.e., gdd south africa with national park staff, gdd bangladesh with live-bird market workers, and gdd thailand with veterinarians) on a variety of one health projects. the gdd program collaborates with experts across cdc, maximizing the subject matter expertise residing in the agency, and with ministries of health and international partners. from to , gdd rc staff authored or co-authored a total of peer-reviewed articles and other significant documents, such as policy documents, position papers, and training manuals. these publications address disease-specific outbreaks and emergencies, surveillance and laboratory science, and cross-cutting priorities related to disease threats. these publications show the diversity and strong scientific foundations of gdd's work. the original overarching goal and purpose of the gdd program was to improve global capacity within partner nations to prevent emerging infectious disease threats at the site of origin, rapidly detect disease events, and respond to outbreaks to mitigate the consequences to the population. the accomplishments of the gdd rcs highlight examples of many firsts: diseases detected before they became significant threats; additions of new laboratory tests to identify the cause of illness; vital workforce training programs begun and expanded; as well as faster, smarter response to outbreaks because of the capacity the program helped build in-country. as previously noted, the gdd program offered an early strategic approach to global health security efforts as countries worked to meet their obligations under the ihr [ ] . when the ihr [ ] were adopted in , the gdd program was uniquely positioned to help close the critical gap between global public heath capacities defined in the ihr [ ] and the ability of many member states to meet these requirements. over a decade after implementation of the ihr [ ] more than countries have extended their commitment to strengthening global public health capacity through the ghsa [ ] . the gdd program again offered a framework forand experience inimplementing the cross-cutting public health systems needed to meet the targets set forth by both ihr and ghsa. the gdd program exemplifies the work that cdc has done to improve global health outcomes and enhance global health security specifically as part of the core functions of the organization. the gdd program unites the resources of the united states and its international partners to provide technical assistance, logistical support, and funding through regional networks and intergovernmental organizations. through this work, we have increased the capacity of the global public health workforce to identify and contain threats. it is critical to note that the value of the in-country work done by the gdd program extends beyond stopping outbreaks. partnerships and relationships formed through the program have contributed to health diplomacy abroad. these critical ties extend our ability to respond in times of crisis, and play an additional role in strengthening other initiatives and programs that protect public health. public health programs like gdd have served as inroads to connection in fragile areas, such as those facing political instability and conflict, because they remove barriers to collaboration by addressing universally acknowledged health needs. the gdd program's efforts over the last decade to improve global public health capacity have, indeed, moved us forward. measurable progress has been made within a focused, but limited, scope. for progress to continue, however, cdc and the global health community must go beyond our initial efforts and work more broadly to confront challenges and embrace opportunities that arise. the gdd program has given us the following important lessons that can inform our next steps: ) create multiregional connectivity. strong networks can harness a variety of strengths, share resources, and connect across disciplines toward common goals. a major success of the gdd program has been to create regional platforms where subject matter experts can engage with one another and programs can break free of their silos. moving from siloed to shared approaches also enhances collaboration on science and research, thereby strengthening the foundation for public health action. global networks have been created by gdd, and more recently with ghsa, in recognition that shared risk means shared responsibility, and the best way to achieve success is by working together to ensure our collective health, safety, and security. ) adopt consistent goals and measures. from the beginning, the gdd program has applied a consistent set of goals and metrics to track progress over time and across programs. the world's global health security efforts are also seeing the benefits of instituting consistent targets, as well as frameworks for measuring success against those targets. over the past few years, the who joint external evaluations have become a valuable tool to track progress on global health security initiatives, both past-to-present and country-to-country [ ] . evaluation is a key part of recognizing accomplishments and is critical to finding gaps we must still address. only once we know where we stand can we take action to implement successful programs and point them in the right direction to reduce our identified vulnerabilities. ) deploy the power of science and data. cutting-edge scientific research has always been at the core of the gdd program's mission. scientific data are the tool we use to detect, respond, and to halt or prevent outbreaks and to inform policy changes that protect public health globally. scientific research helps partners make evidence-based decisions and implement effective local solutions that eliminate outbreaks at their source. additionally, taking an active role in teaching others how to capture, analyze, and effectively use public health data creates a workforce capable of rapidly recognizing and responding to threats. future scientific progress will require not only improved connection across scientific disciplines, but also sustained and dedicated commitment to a unified scientific strategy. ) build trusted partnerships. the gdd program's success has relied on strong partnerships. the program's longstanding presence in regions across the globe has proven that in-country engagement leads to trust. this trust becomes particularly valuable in outbreak response, as global partners rely on cdc data and expertise as a resource that saves lives. strong partnerships at all levels are critical to global health security, and the process of creating gdd rcs has formed and strengthened partnerships at all levelsgovernment-to-government relationships, collaboration with other organizations and non-governmental organizations (ngos), and local and personal connectionsthat can be leveraged to address critical public health priorities. ) build for flexibility. cross-cutting public health programs give us the ability to respond to any crisis, regardless of cause. strong core systems and connected resources can pivot when needed to address emerging or reemerging threats. as threats change, and as science changes, funding tied to a single disease may prove limiting in its scope. conversely, investment in core public health capacity ensures that a single mission does not dictate the longevity or capacity of a program, and that we can continue to maintain and grow our valuable resources, expertise, and connections. flexible, nimble systems are our best answer to an unpredictable future. while there have been many successes and substantial impacts made by gdd rcs, there have also been significant challenges recognized. some of these have impacted the ability of the gdd program to accomplish one of its primary goals: helping countries achieve ihr compliance. despite the global prominence of infectious diseases, there are few rigorous and precise estimates of the burden and etiology of key infectious disease syndromes in developing countries [ , ] . some of the problems in measuring the burden of these diseases in developing countries have included poor access to the clinical facilities, lack of accurate or available laboratory diagnostics, and absence of population-based surveillance systems needed to accurately assess incidence rates. accurate information on burden of the most important infectious disease syndromes is needed by ministries of health and public health policy decision-makers to set current priorities for optimal use of limited resources for public health programs. efforts to assist our partner countries in building national laboratory and surveillance systems have been significantly hampered by insufficient resource allocationboth financial and staff time. this has led to a greater recognition of the actual time and money required to develop and maintain such systems. another challenge has been the need for better coordination and communication of a unified mission and objective that is supported, fully adopted and implemented in all of the gdd rcs. in some instances, lack of clarity on adopting and implementing a unified mission led to a divergence of operations and a mixture of activities driven, in many cases, by individual investigator interests and expertise in country. the inability to have every kind of public health expertise represented among country-based staff highlights the need for sustained and active scientific engagement across the agency. the public health science conducted through such activities has been commendable; however, the data generated has not always been completely successful in informing policy for ministries of health (i.e., vaccine coverage, educational campaigns targeting high-risk populations, improvement or development of vector-control programs). more needs to be done to ensure that data are applied to their full potential in improving the health of the populations served. finally, although there have been some cross gdd rc projects (e.g., use of a multipathogen taqman array card to identify the etiology of community-acquired pneumonia, c. van beneden pers com), overall, it has been a challenge for the gdd rcs to link across a network of regional offices or platforms to implement unified protocols or projects (i.e. estimating burden of a specific disease, measuring the effect of a specific medical countermeasure, etc.) in multiple countries, throughout multiple populations, in diverse ecologies, and among unique cultural settings. building the capacity to do this could strengthen the overall goals of global health security to prevent, detect and respond to health threats. the gdd program is part of a long and significant history at cdc of protecting health globally, ranging from smallpox eradication, polio elimination, hiv, malaria, and cholera control to emergencies including sars, h n , ebola, and zika. as this history shows us, global health is never static, and the work is not finished. as we look to the future, our biggest challenge remains the unknown. health threats will continue to take us by surprise. the nature of disease means that we cannot always predict what the next outbreak will be, or where and how it will spread. ever-increasing interconnection across the globe means that when the next outbreak does take hold, it will be capable of spreading rapidly. to stop it, we will need systems in place that are sensitive enough to signal a new health threat, specific enough to pinpoint problems and focus resources, and flexible and connected enough to protect the world's economic and social wellbeing. we must recognize that global health security begins locallyif there are gaps anywhere in the system, disease will find it. lessons learned through the lens of the gdd program can offer us a way forward. more than a decade of successes and failures has given us information and evidence-based strategies essential to developing core public health capacities around the world. these strategies include increasing coordinated, multi-center scientific collaboration across nations to strengthen the global network; increasing the number of public health professionals trained; broadening and strengthening global partnerships; and reducing gaps in global preparedness for emerging health threats. as the global health community looks for the best ways to operate in our changing world, lessons from the gdd program will continue to inform our work. we have an obligation to keep our nation and our world safe, healthy, and secure. we must therefore continue our effortsand commit to doing much moreto improve what we can, where we can, on a continual basis. we can afford nothing less. risk factors for human disease emergence ecology of zoonoses: natural and unnatural histories factors in the emergence of infectious diseases urbanization and disease emergence: dynamics at the wildlife-livestock-human interface human-livestock contacts and their relationship to transmission of zoonotic pathogens, a systematic review of literature prediction and prevention of the next pandemic zoonosis the economic case for a pandemic fund us centers for disease control and prevention and its partners' contributions to global health security who issues a global alert about cases of atypical pneumonia the severe acute respiratory syndrome progress and opportunities for strengthening global health security global disease detection-achievements in applied public health research, capacity building, and public health diplomacy one health: building interdisciplinary bridges to health in a globalized world the global health security agenda performance of veterinary services pathway international health regulations--what gets measured gets done first laboratory confirmation on the existence of zika virus disease in india tahyna virus and human infection an outbreak of acute febrile illness caused by sandfly fever sicilian virus in the afar region of ethiopia epidemiology of severe pneumonia caused by legionella longbeachae, mycoplasma pneumoniae, and chlamydia pneumoniae: -year, population-based surveillance for severe pneumonia in thailand surveillance for respiratory infections in low-and middle-income countries: experience from the centers for disease control and prevention's global disease detection international emerging infections program incidence of pneumococcal pneumonia among adults in rural thailand, - : implications for pneumococcal vaccine considerations incidence and clinical features of respiratory syncytial virus infections in a population-based surveillance site in the nile delta region national surveillance of health care-associated infections in egypt: developing a sustainable program in a resource-limited country surveillance for hospitalized acute respiratory infection in guatemala the substantial hospitalization burden of influenza in central china: surveillance for severe, acute respiratory infection, and influenza viruses building global epidemiology and response capacity with field epidemiology training programs monitoring and evaluation framework committee on emerging microbial threats to health in the st century public health surveillance and infectious disease detection we thank alexis adams for leading efforts to compile and review the contents of this supplement; radha friedman for the collection and review of the gdd program indicator data; past and present us government and locally employed staff of the gdd regional centers for their work on the activities described; cdc technical experts that provide assistance for the activities at the gdd regional centers; and the over government, ministries of health, ministries of agriculture, academic institutions, research institutions, and other partners that continue to work with cdc to enhance public health and improve global health security. the findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the centers for disease control and prevention. publication costs are funded by the u.s. centers for disease control and prevention.about this supplement this article has been published as part of bmc public health volume supplement , : th anniversary of the centers for disease control and prevention -global disease detection program. the full contents of the supplement are available online at https:// bmcpublichealth.biomedcentral.com/articles/supplements/volume- supplement- .authors' contributions jmhelped conceptualize manuscript, supervised data analysis and was the primary author of the manuscript. awanalyzed and co-drafted manuscript. shhelped conceptualize manuscript, supervised data analysis and codrafted the manuscript. dphelped conceptualize manuscript and co-drafted the manuscript. ohorganized framing of and co-drafted manuscript. jaco-drafted manuscript. kiprovided early leadership towards the development and implementation of the gdd program and contributed towards the writing, editing, formatting of the manuscript. fareviewed and edited manuscript. sdreviewed and edited manuscript. rkhelped conceptualize manuscript and supervised data analysis. all authors have read and approved the final manuscript. the authors declare that they have no competing interests. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.author details key: cord- -ybgby v authors: burdick, william; dhillon, ibadat title: ensuring quality of health workforce education and practice: strengthening roles of accreditation and regulatory systems date: - - journal: hum resour health doi: . /s - - - sha: doc_id: cord_uid: ybgby v regulation of the health workforce and accreditation of educational institutions are intended to protect the public interest, but evidence of the impact of these policies is scarce and occasionally contradictory. the body of research that does exist primarily focuses on policies in the global north and on the major health professions. stress on accreditation and regulatory systems caused by surges in demand due to the covid- pandemic, privatization of education, rising patient expectations, and emergence of new health worker categories has created urgency for innovation and reform. to understand and evaluate this innovation, we look forward to receiving manuscripts which contribute to the evidence base on the implementation, management, and impact of health worker education and practice regulation, including the intersection of education accreditation and workforce regulation policy. we particularly look forward to manuscripts from underrepresented parts of the globe and underrepresented health workforce sectors that address policy effectiveness, explore different models of regulation, and present innovations that we can all learn from. the health workforce is an important contributor to delivering health and economic prosperity [ ] . quality, accessibility, acceptability, distribution by cadre and geography, and coordination across health cadres and with other aspects of the health system are all critical elements for an effective health workforce. factors that affect the quality and health workforce sustainability include who is chosen to enter the field, what they are taught, how they are taught, how they are determined to be qualified to enter the field, how they maintain and update their skills, and how they are disciplined. health workforce accreditation and regulation systems shape all of the above. health professional regulatory processes have also been used to give effect to broader priorities related to equitable distribution, international cooperation, dual practice, and compulsory service programs. as such, the world health organization's global strategy on human resources for health: workforce [ ] emphasizes the importance of effective health personnel regulation to achieve universal health coverage, with an important role in both optimizing the existing health workforce and in aligning investments with the current and future health workforce needs. these attributes are themselves underpinned by systems that must assure the quality of education institutions to produce the needed health workers and the appropriate level of oversight of health occupations to ensure the public interest. regulatory mechanisms and resources across countries of varying income classification, however, are under stress due to the increasing volume and privatization of health professional education [ ] , rising importance of previously unregulated occupations [ ] , emergence of new occupations, emergencies and humanitarian crises, new modes and cross border service delivery (e.g. use of digital technology), accelerating international mobility of health workers (oecd ), and escalating patient demand and expectation. the covid- pandemic has further highlighted the importance of strong and dynamic health workforcerelated regulatory systems. the pandemic has stressed health workforces in waves across the world as cases and deaths surged in different locations. alongside the supply chains and beds, health workers were in short supply or will be in short supply as surges in the number of cases continue to occur. in response, health professional regulations and associated processes were rapidly modified in many jurisdictions to expand the workforce by temporarily expanding scopes of practice and modification of professional titles, enabling the practice of retired and foreign health workers, and earlier clinical service by students [ ] . in some settings, the curriculum for student health workers was modified to better prepare the workforce for the pandemic [ ] . the covid- pandemic brought into relief both the importance of and existing gaps in health workforce regulatory systems. lessons learned from these efforts are important to share. while jurisdictions attempt to assure education quality through accreditation, the evidence is sparse, difficult to generate, and sometimes contradictory. accreditation systems may hold institutions accountable for various elements of the education system but may also inhibit innovation and can divert resources from other worthy efforts to improve the availability and quality of health services. similarly, regulatory systems intended to protect the public can unduly inhibit prospective individuals from entering the workforce and may impose a burden that may not advance wellness or quality [ , ] . several factors in health workforce accreditation and regulation affect access. one is the local delineation of the "public interest" which these constructs are intended to serve. the interplay between market forces, political interests, and health workforce regulation determines many of these attributes. entry into the field is often controlled by a licensing process that involves documentation of education and individual assessment of knowledge and skill, combined with evidence of good standing in the community. retention of the license in many jurisdictions is contingent on evidence of continued education and re-examination of knowledge or skills. in some fields, passing a certifying examination is sufficient. finally, the public sector or publicly sanctioned entities pass judgment based on standards for the education systems in a process known as accreditation. we would like to encourage development and publication of the evidence examining the impact of these regulations on the expressed "public interest." moreover, the goals for education accreditation and workforce regulation overlap, or should overlap-regulatory thresholds for knowledge and skill should be achieved by students during the education process. that education process is evaluated by a system that is hopefully aligned with that of licensing, ensuring a smooth transition from student to practitioner. we hope to address many of these issues in this thematic series. our aims are to: . identify empirical evidence on the impact of accreditation of education institutions on improving the quality of health worker education . identify empirical evidence on the impact of health professional regulation on patient safety, quality, and broader health system objectives . identify innovations in the professional regulation of health workers and the underlying drivers for reform . explore the link between accreditation of education institutions and the broader regulation of professional practice . provide an opportunity to present low-and middleincome country processes and practices in accreditation and health professional regulation that are currently underrepresented in the literature . fill the gap in regulatory and accreditation data, evaluation, and research about health occupations such as accelerated medically trained clinicians, community health workers, dental assistants, optometric technicians, and other health occupations under-represented in the literature in this thematic series, we are particularly interested to receive manuscripts which contribute to the evidence base on the implementation, management, and impact of health worker education and practice regulation. manuscripts should be nationally or internationally policy-relevant. submissions should address one or more of the following: diversity of national, multi-national, and subnational approaches to accreditation and regulation facilitators and barriers to effective regulation and accreditation societal impact of accreditation and regulation implementation challenges for accreditation and regulation-related laws and policies data sharing on implementation and impact of regulation and accreditation few publications address the overlapping goals of education accreditation and practice regulation [ ] , and we hope this series motivates researchers, analysts, professional bodies, and policymakers to generate this evidence. diversity of approaches to the challenges of accreditation and regulation will be emphasized. the series has the potential to provide much-needed evidence for the efficacy of health workforce education and practice policies. finally, accreditation and regulatory research priorities were developed by a consensus process in a paper by ranson et al. in [ ] . while the priorities may need to be updated with a similar process, the list appears relevant. the priorities included the following: how effective are accreditation interventions in improving performance, how effective is re-licensing in improving health worker performance, what are the relative strengths and weaknesses of different models for regulating the private sector in lmics, how can regulatory bodies be made more effective in regulating practice, and what is the optimal mix of financial, regulatory, and non-financial policies for improving the distribution of health workers? we hope that researchers will consider these questions for inclusion in this series. high-level commission on health employment and economic growth global strategy on human resources for health: workforce the economics of health professional education and careers: insights from a literature review is health practitioner regulation keeping pace with the changing practitioner and health-care landscape? an australian perspective. front public health the role of medical students during the covid- pandemic covid- : medical schools given powers to graduate final year students early to help nhs licensing occupations: ensuring quality or restricting competition? kalamazoo regulation and quality improvement. a review of the evidence. the health foundation. london: the health foundation priorities for research into human resources for health in low-and middle-income countries publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations authors' contributions both authors contributed equally to the conception and writing and have read and approved the final manuscript. availability of data and materials not applicable ethics approval and consent to participate not applicable consent for publication not applicable the authors declare that they have no competing interests. key: cord- -mf b p authors: buckley, ralf; westaway, diane title: mental health rescue effects of women's outdoor tourism: a role in covid- recovery date: - - journal: ann tour res doi: . /j.annals. . sha: doc_id: cord_uid: mf b p mental and social health outcomes from a portfolio of women's outdoor tourism products, with ~ , clients, are analysed using a catalysed netnography of > social media posts. entirely novel outcomes include: psychological rescue; recognition of a previously missing life component, and flow-on effects to family members. outcomes reported previously for extreme sports, but not previously for hiking in nature, include psychological transformation. outcomes also identified previously include: happiness, gratitude, relaxation, clarity and insights, nature appreciation, challenge and capability, and companionship and community effects. commercial outdoor tourism enterprises can contribute powerfully to the wellbeing of women and families. this will be especially valuable for mental health recovery, following deterioration during covid- coronavirus lockdowns worldwide. leisure tourism is a discretionary activity to improve individual wellbeing. worldwide, poor mental health and wellbeing impose large social and economic costs on human civilisations (mcdaid, park, & wahlbeck, ; patel et al., ) . these costs amounted to ~ % of global gnp prior to the / covid- coronavirus pandemic. they are increasing currently through covid- lockdown, isolation and quarantine measures (brooks et al., ) . by improving wellbeing, tourism can reduce these costs. this generates an economic value within the healthcare sector, additional to that within the tourism sector. in particular, exposure to nature generates a substantial and diverse set of mental health benefits (bratman et al., ; frumkin et al., ) . these confer an additional economic value on national parks, estimated at > us$ trillion p.a. worldwide . this health services value is generated via outdoor nature and adventure tourism and recreation (buckley, (buckley, , . it is at least ten times larger than the direct economic value of tourism in parks (balmford et al., ) . the health services value of nature and adventure tourism and recreation is already embedded in the structure of modern human societies and economies. if people did not engage in these activities as discretionary self-funded leisure, the costs of poor mental health would increase, by an estimated additional . % . these additional costs are indeed now being incurred, as one component of the social and economic costs of covid- lockdowns. costs include treatments, carers, lost workplace productivity, and increased antisocial behaviour, both public and domestic. domestic violence, one of the key cost components, has already increased as one result of covid- family confinement (brooks et al., ) . irrespective of the current covid- pandemic, women worldwide are disproportionately susceptible to many of the causes of poor mental health (halliday, kern, & turnbull, ; hodes & epperson, ) . this occurs through: domestic violence and table disciplinary paradigms relevant to tourism as therapy. practice paradigm research paradigm wellbeing tourism, eg spas, yoga individuals travel to buy spa, yoga or other wellness experiences. tourism: providers capitalise on individual discretionary expenditures to improve self-perceived wellbeing medical tourism individuals travel for mainstream or cosmetic medicine, to get better price, quality, equipment, safety, legality. tourism business: medical facilities as attraction. individual discretionary choices, funding, outcomes. nature and adventure tourism individuals travel to watch wildlife, see scenery, experience emotions, achieve adventure goals. tourism: interactions between commercial tour operators and their clients, including geography, motivations, satisfaction, etc. leisure, stress reduction some discretionary leisure activities can reduce stress, eg from the workplace. r. buckley and d. westaway annals of tourism research ( ) tourism and wellbeing; medical tourism; leisure and wellbeing; outdoor recreation; outdoor education; nature and mental health; therapeutic landscapes; healthcare policy; the economics of nature conservation; and women's outdoor recreation and mental health specifically. in tourism, the most relevant theoretical framework has been that of wellbeing, quantified through descriptive quality-of-life measures (lengieza et al., ; uysal, sirgy, woo, & kim, ) . this is a heavily studied field, with several recent reviews (pyke, hartwell, blake, & hemingway, ; smith & diekmann, ; uysal et al., ) . there is also a parallel but more prescriptive field known as positive psychology (coghlan, ; filep & laing, ; nawijn & filep, ; vada et al., ) . all this research has focussed on healthy individuals, not medical patients. there are distinct sets of research on spa, retreat, yoga and wellness tourism (bowers & cheer, ; chen & li, ; gabor & oltean, ; pyke et al., ) ; and on medical tourism (hoz-correa, munoz-leiva, & bakucz, ; mathijsen, ) . those, however, do not address the social and mental health outcomes of tourism generally. leisure research argues that non-work discretionary activities reduce stress (denovan & macaskill, ) , and improve quality of life (iwasaki, ; wensley & slade, ) , through preventive and therapeutic pathways (fenton et al., ; l. fenton, white, gallant, hutchinson, & hamilton-hinch, ; l. fenton, white, hamilton-hinch, & gilbert, ; y. iwasaki et al., ; y. iwasaki, coyle, & shank, ) . non-commercialised outdoor recreation, including exposure to nature, can yield a wide range of health benefits, both physiological and psychological (biedenweg, scott, & scott, ; bratman et al., ; davies, ; kondo, jacoby, & south, ; twohig-bennett & jones, ) . those benefits include reduced incidence of medically diagnosed syndromes, such as clinical depression and alzheimer's and parkinson's diseases (hansson et al., ; svensson et al., ; tomas, martina, ulf, stefan, & tomas, ) . critically, they include marginal gains beyond those of exercise alone (araújo, brymer, brito, withagen, & davids, ; bélanger et al., ; blondell, hammersley-mather, & veerman, ; chekroud et al., ; clough, mackenzie, mallabon, & brymer, ; elbe, lyhne, madsen, & krustrup, ; frühauf et al., ; horowitz et al., ; niedermeier, einwanger, hartl, & kopp, ; pasanen, white, wheeler, garrett, & elliott, ; white et al., ) . mental health benefits have been shown for many different types of adventurous outdoor recreation (araújo et al., ; buckley, a; collins & brymer, ; frühauf et al., ; hansson et al., ; hetland, kjelstrup, mittner, & vitterso, ; holland, powell, thomsen, & monz, ; holmbom, brymer, & schweitzer, ; morris & scott, ; niedermeier et al., ; roberts, jones, & brooks, ; white et al., ) . benefits have also been demonstrated for contemplative outdoor activities, such as forest walks (chen, yu, & lee, ; hansen, jones, & tocchini, ; kobayashi et al., ; lyu et al., ; morita et al., ; oh et al., ) . there is a parallel field of geographical research on therapeutic landscapes (bell, foley, houghton, maddrell, & williams, ) . research in outdoor recreation has focussed on healthy individuals, rather than clinically diagnosed patients, though a few studies have compared healthy and unhealthy subjects (ower et al., ) . mental health benefits from activities in outdoor nature have been summarised in several recent reviews and meta-analyses (bratman et al., ; buckley & brough, a; frumkin et al., ; kondo et al., ; oh et al., ; seymour, ; shanahan et al., ) . benefits can occur across a wide range of mental health parameters, environments (biedenweg et al., ; wyles et al., ) , and personality types . they may have considerable economic value . in the health sector, the fundamental paradigm is the diagnosis and treatment of patients who present with illnesses. only the public health subsector includes preventive measures for individuals currently in good health, as well as therapies for those who are not. poor health, mental as well as physical, is considered to incur substantial social and financial costs, at all scales from individual to national economy (mcdaid et al., ; patel et al., ) . considerable effort is devoted to measuring and minimising each component of these costs. implementation of nature-based therapies in mental healthcare lags research (buckley & brough, b; buckley, brough, & westaway, ; van den berg, ) . prescriptible therapies need design, dose, and duration of individual treatments and entire courses of therapy, in relation to symptoms, severity, and patient personality. quantitative data on design-dose-duration-response relationships are not yet available (bratman et al., ; buckley, brough, b; frumkin et al., ; shanahan et al., ) , though research has begun . prescriptible therapies need institutional systems for diagnosis, prescription, certified providers, and funding (buckley et al., ) . commercial outdoor tourism can capitalise on this by repackaging tourism products as therapies (buckley, ) . maintaining and improving mental health is valuable both socially and economically. many people are mentally languishing rather than flourishing (keyes, of the population each year experience common mental health disorders (australia institute of health and welfare, ) . treatment by prescribing opioid antidepressants has created very large secondary social costs through addiction (johnson, eriator, & rodenmeyer, ; kolodny et al., ; kolodny & frieden, ; murthy, ) . this opioid epidemic has triggered trillion-dollar litigation worldwide, and is one factor driving recent interest in outdoor therapies as alternatives. in urbanised developed nations, the total economic costs of poor mental health were estimated, prior to the covid- pandemic, at ~ % of gdp (buckley, brough, a , b australia, productivity commission, ) . costs include treatments, carers, lost workplace productivity, and antisocial behaviours (buckley et al., ) . in the longer term, costs are growing, because of increasing individual longevity, workplace stress, and childhood videophilia (cooper, ; pergams & zaradic, ; soga & gaston, ; zhang, goodale, & chen, ) . as children spend less time outdoors, this creates health costs that persist throughout adulthood (engemann et al., ; lee et al., ; stafford et al., ) . as individuals live longer in poor mental health, this imposes additional health costs through the need for mental health care and treatment over an extended period of years. currently, covid- lockdowns are increasing these costs worldwide (liu, bao, huang, shi, & lu, ; mazza et al., ; pierce et al., ; vizard, davis, white, & beynon, ; wang et al., ) . women have historically been under-represented in outdoor tourism research and practice, though there is now a growing recognition of gender differences (evenson et al., ; pohl, borrie, & patterson, ) , across the entire life course (carmichael, duberley, & szmigin, ; cosgriff, little, & wilson, ; wharton, ) . women may have different motivations and learning styles than men (kiewa, ; whittington, ) ; face different barriers and encouragements to take part in various outdoor activities (doran, schofield, & low, ; little, ; loeffler, ; mcniel, harris, & fondren, ; morris, van riper, kyle, wallen, & absher, ) ; and attach importance to different aspects and achievements (kiewa, ; nolan & priest, ) . there is also a small and recent research literature on family adventure tourism, where parents and children take part jointly (pomfret, ; g. pomfret & varley, ) . regular walking groups and programs as a form of low-key therapy, especially for women, have received particular attention recently (davies, ; duncan, gordon, & scott, ; hanson & jones, ; kelly et al., ; legrand & mille, ; marselle, warber, & irvine, ; robertson, robertson, jepson, & maxwell, ) . simply encouraging people to walk regularly, however, is ineffective (hillsdon, thorogood, white, & foster, ; ogilvie, foster, & rothnie, ) . a suite of social levers is required to achieve high take-up and repeat activity (buckley et al., ) . women may also experience different patterns in mental health than men, at all life stages. these may depend on social and cultural context as well as individual physiological factors. across all life stages, higher proportions of women than men experience depression, in a wide range of countries and societies (bale & epperson, ; halliday et al., ; hodes & epperson, ; kessler, ; lemoult & gotlib, ; salk, hyde, & abramson, ) . any measures, including outdoor tourism, that can counteract poor mental health in women specifically, thus gain particular social and economic value. all of these considerations point towards a new social importance of outdoor tourism, and a new and potentially very large market for outdoor tourism products. this has only recently been identified. buckley ( ) reanalysed previously published ethnographic datasets from a range of nature and adventure tourism products, picking out components related to mental health. outcomes included positive emotions, recovery from stress, and changed worldview. levi, dolev, collins-kreiner, and zilcha-mano ( ) conducted repeated clinical interviews, using a psychiatric rating scale, with patients diagnosed with major depressive disorders, who were voluntarily taking part in self-purchased tourism products, of various types. they found that mental health condition improved for some patients, but worsened for others. their sample was too small, and non-randomised, to identify causes of these differences. buckley ( ) conducted brief interviews with tourists visiting forest and beach parks in australia, and found that % perceived park visits as contributing to health and happiness, rather than the reverse. overall, there has been quite limited research to date on the role of tourism as a prescriptible therapy. the approach taken here differs from any of these previous studies. we analyse a portfolio of closely related and cross-marketed tourism products, offered repeatedly by the same company in multiple years and locations. we focus specifically on mental and social health outcomes perceived by participants. this appears to be the first analysis to adopt this approach. in addition, the tourism products in this portfolio are marketed principally or exclusively to women. this analysis examines effects not only on participants, but also on their families. this appears to be a novel dimension in this research field. the authors are experienced in outdoor tourism and recreation, but are not psychologists or mental health practitioners. our participants are drawn from the clientele of an australian tourism enterprise that offers three relevant products. the first consists of one-day hiking tours, now a widespread tourism product (davies, ; ower et al., ) . the second consists of multiweek wilderness hiking and trekking tours worldwide, part of the global adventure tourism sector. the third consists of three-month commercial charity challenge events (coghlan & filo, ) , run in various australian states (buckley et al., ; westaway, ) . the company has ~ , clients to date, about % of the adult female population of australia. this portfolio was selected since: (a) it is offered and repeated regularly; (b) it encompasses a wide range of durations, to maximise the opportunity to generate mental and social health changes; (c) at least for the introductory products, it is inexpensive, so that individuals can take part across a wide range of socioeconomic circumstances; and (d) the products each have entirely or largely female clientele. the methodology adopted is internet-based ethnography, known as netnography (kozinets, (kozinets, , . this is a minimallyintrusive, open-ended, qualitative methodology, analysing internet-accessible electronic text written directly by the participants themselves. such approaches are now widespread throughout the social sciences, including leisure and tourism (canavan, ; mkono & markwell, ; tavakoli & mura, ; veal, ) . they are non-invasive, and can capture a large volume of material rapidly. their main disadvantage is that the researcher does not interview the participants directly, and hence cannot use the cues of spoken or body language in interpretation, nor ask follow-up questions or probe for inconsistencies. in addition, the researcher may not share the participants' experience. the analysis used both a standard passive netnography based on social media postings, and an actively catalysed variant. for the former, the first author trawled through publicly accessible facebook® posts by clients of the company concerned. these were identified by starting with the social-media "friends" of the founder's professional page, and expanding to "friends of friends" where permitted by privacy settings. this was continued until well over individual posts had been examined, posted by several hundred different individuals, all female. many posts were responses to a video presentation (westaway, ) . we excluded posts referring only to physical fitness, and very brief posts with limited conceptual content. for the catalysed netnography, we used a -member private facebook® group, all female, maintained by tour company clients. an administrator posted an enquiry, and relayed the response posts to the first author, anonymously. the question was neutral, asking how participants' mental health, and their families', was affected by these tourism products. the enquiry outlined the research, and included consent for use of responses. this is netnography, since materials were posted on social media, visible to other group members, and analysed without interviews, exchanges, or identification. it is catalysed, since the enquiry posted by the administrator led members to post complex comments specifically in response. all text was analysed jointly using constant-comparison grounded-theory paradigms (glaser & strauss, ; stern & porr, ) . concepts were extracted, coded, and classified iteratively, to build a coding tree (buckley, b; glaser & strauss, ; stern & porr, ) . coding was checked by two independent analysts. iterations were repeated until theoretical saturation and efficient coding were achieved (aldiabat & navenec, ; buckley, b; denovan & macaskill, ; nelson, ; saunders et al., ) . netnography reveals the range of outcomes perceived by participants, but not their distribution. outcomes are not clinical assessments, but most participants' mental health concerns were sub-clinical, where their own perceptions are sufficient. therefore, this approach is a reliable first step in assessing mental and social health benefits achieved through participation in nature-based outdoor tourism. as in all netnographies, the demographic and socioeconomic characteristics of individuals posting each item are unknown unless revealed within individual posts. for this analysis, items were posted under real names, verified by the tour company. all participants were female. most are urban women with families, with a few younger members. from a tourism perspective, they are domestic rather than international clients. in the analysis, saturation was achieved rapidly. the coding tree is summarised in table . major constructs are expanded below, with illustrative quotes. posts focussed heavily on the experience and its outcomes for themselves and their friends and families, matching the aims of this study. participants referred to their overall state of health, saying that participation "definitely improved my state of mind, physical and emotional health", producing a "healthy mind, body and spirit". some added that they "gain mental strength", "feel so good", "so happy", or even an "overabundance of joy and happiness". one said: "when i have been out walking, i feel … amazing, happy, fulfilled, rich, in love, energetic, inspired, unbeatable, exhilarated, motivated, strong, clever, fit". they felt "lucky", "fortunate" and "blessed", and that they had received "a gift" or even "the greatest gift ever". they said that they took the opportunity to "immerse myself in nature" and "appreciate the beautiful surroundings". they referred to "amazing places", "beauty", "magic" and "positive energy." participants mentioned that: "i instantly feel relaxed the moment i'm out in nature", "it allows me to unwind or switch off when i need to", and that it provides "a big stress release" allowing them to "find peace" and "sleep better". some referred to the high stresses of daily life, and the need for escape: "pretty hectic .. small kids .. working .. demanding job .. getting out is my only real 'me time'"; "busy city ... stresses & strains … rat race … craving time outside". as a result, participants found that "nature gives me the answers" to "clear [my] head" so as to "find myself, redefine myself", through "'thinking' me-time", which "fills my mind with balance". participants said that taking part in these outdoor hiking tours "gives me challenges" or even "challenged me to push myself more than i would ever have thought possible". they found "strength and stamina you never knew existed in you", and that ultimately "every step ... is possible", and that "however difficult, [it is] so worth it". transformation was mentioned frequently: "life changer", "changed my life", "huge impact on my life", "it can change your life for a minute, a day, a lifetime", "that mountain called life becomes so climbable". the theme of new opportunity, or a previously missing life component, was reflected in phrases such as "missing link", "the piece of me that had been missing", "whole new world", and "you don't know how much you need nature until you take that step outside". the most powerful mental health theme was that hiking in natural surroundings with like-minded female companions had rescued them psychologically from dark and difficult times. they said that it "got me through some of my darkest times" or "brought me back from dark times", providing "a way forward when i was lost". they referred specifically to mental state, saying that it "improved my state of mind when i hit an all-time low" or "helped me regain the state of mind i felt i had lost forever". some went even further: "i don't know how i would have coped without it", "it saved my mind many times over". participants referred repeatedly to companionship, community, and support: an "amazing community of women", "powerful and nurturing", with a "big vision". they argued that "women need other women to flourish", and spoke of the "camaraderie of so many likeminded women." at a smaller and shorter scale, they mentioned "walking in nature with friends", using terms such as "friendship", "connecting", "group", "safe group" and "team". one said that she was "inspired to create my own weekly women's walking group". participants acknowledged staff of the tour company, saying "thank you for everything you do for us", and also companions: "my fellow hikers .. have taken me into their hearts". participants referred to a general improvement in their own attitudes towards their families after taking part in these products, saying that they "come home to my family from my walks feeling rested and invigorated", with "renewed positivity and resilience" and "a lot more energy and patience to give to my husband and two small kids". one said "i'm a nicer person, mother and wife when i get out in nature", and another, that her husband "definitely sees a positive effect in me". in summary, "happy mum usually equals happy family." some table coding: concepts, constructs, & key terms. mentioned that their children had followed their example: "they know i do it … they ask to go too"; "it inspires my kids to go out bushwalking"; and "my five-year-old decided to go for a run". for some, the effect flowed in the opposite direction: "my daughter inspired me", or both at once: "my daughter and i [took part] together". many of these women reported that it took some time for their husbands or partners to accept and respect it: "my husband was not happy at all at first", but now "he has got used to it". for some, this "inspired my husband to enjoy his own pursuits 'guilt-free'". for others, their husband now "encourages and supports me to get out there", and "fully supports my involvement". the overall outcome was improved family cohesion. participants said that "my family …. thinks it's amazing" and that "a family that walks together lives happily". they said their children "love it when we go on bush walks together", that "we really enjoy going for long hikes together", and that they treat "walks with our kids as special family bonding time that we treasure". the end result is a "happier more cohesive household". we identified basic themes, classified into psychological constructs and social constructs (table ) . we presented the psychological constructs in groups: happiness and gratitude; relaxation, release, and clarity; capability, transformation, and missing life components; and psychological rescue. we presented the social constructs in groups: companionship and community; family attitudes and children; and spousal support and family cohesion. this is a novel set of results, not reflecting any previous analysis. it is a different set of constructs from that identified previously for a much broader range of outdoor adventure tourism participants (buckley, ) . that previous analysis indicated that mental health outcomes of outdoor tourism could be classified into short-term emotional responses, medium term stress-recovery effects, and longer-term worldview changes (buckley, ) . below, therefore, we discuss in more detail, which of our findings are comparable to those from previous research, and which appear to be entirely new. the covid- pandemic during has created major social, economic and environmental changes, the "anthropause" (rutz et al., ) , with unknown future scale and duration. there is widespread deterioration in mental health, due to concerns over family health, loss of livelihood, and lockdowns (brooks et al., ; liu et al., ; mazza et al., ; mucci, mucci, & diolaiuti, ; pierce et al., ; vizard et al., ; wang et al., ) . international tourism is interrupted, and domestic tourism reemphasised, with surges in national park visitation. there are thus new opportunities for outdoor tourism enterprises demonstrating psychotherapeutic outcomes (buckley, ) . here, we showed that relatively low-key, localized outdoor tourism products can indeed improve the mental health of their clients. our data were compiled prior to the pandemic, but their importance has increased as a consequence of the pandemic. our approach adopts the recently proposed tourism-nature-health theoretical paradigm (buckley, (buckley, , buckley, zhong, & martin, ) . this paradigm argues that for the us$ billion p.a. parks and nature tourism sector (balmford et al., ) , mental health is an integral consideration across the entire sector. our findings here, from a commercial outdoor tourism clientele now representing % of the adult female population of australia, show that tourism can generate substantial and widespread psychotherapeutic benefits. these are novel findings, with considerably greater scale, scope, and generality than any previous analyses (buckley, ) . they provide large-scale empirical support for the tourism-nature-health paradigm. maintaining or improving mental health is a major motivation to visit parks and nature, and tourism provides the mechanism. this paradigm is broader than previous theoretical approaches to tourism and health, which framed wellness tourism as purchasable products or luxury goods (lengieza et al., ; smith & diekmann, ; vada et al., ) . it will influence how we analyse the motivations, expectations, experiences, satisfaction, and intentions of nature tourists; and the design, pricing and marketing of nature tourism products and destinations. its theoretical ramifications are thus widespread. our findings here confirm emotional, restorative, and worldview psychological outcomes (buckley, ; xie & fan, ) . they also demonstrate, for the first time, that commercial nature tourism can create therapeutic effects such as psychological rescue, recognition of previously missing life components, and flow-on to family members, which are key aims of clinical mental health treatments such as chemotherapies and counselling (bourdon, el-baalbaki, girard, lapointe-blackburn, & guay, ; lee, bullock, & hoy, ; mueser et al., ; swan, keen, reynolds, & onwumere, ) . the concept of emotional rescue is well established within popular culture (richards & jagger, ) , but using tourism to achieve it is a new addition to social practices (buckley et al., ) . the concept of a missing life component, revealed through outdoor tourism products based on walking in nature, is also novel. there is extensive research on what constitutes a full or meaningful life, in different cultures (hooker, masters, & park, ; steptoe & fancourt, ) . the perspective put forward here by individual participants, however, that their lives were unknowingly incomplete until nature was included, is novel. previous research on tourism and wellbeing has treated holidays as adding quantitatively to quality of life, but here we show that it can also add a qualitatively new life component, a more powerful finding. flow-on effects of improved mental health to other family members are also a novel finding. it has been well established that poor mental health in parents, both female and male, has flow-on consequences for children (bowlby, ; flouri & buchanan, ; lavenda & kestler-peleg, ; luebbe & bell, ; repetti, taylor, & seeman, ) , and that these may persist lifelong (fingerman, huo, graham, kim, & birditt, ; lee et al., ; mallers, charles, neupert, & almeida, ; stafford et al., ) . here we show that women's walking-in-nature tourism also yields benefits for partners and children. future research could therefore include interviews with all the family members concerned. outdoor tourism may also yield direct benefits for men's mental and social health, and for singles, grandparents and retirees, not included in the current study. results reported here reveal a much wider variety of mental health outcomes than previous analyses of outdoor recreation. some of the outcomes identified, such as transformation, gratitude, and clarity, whilst not reported previously for hiking, have been identified for highly active outdoor pursuits, including extreme sports (booth, ; buckley, a; collins & brymer, ; holmbom et al., ; houge mackenzie & brymer, ; morris & scott, ; roberts et al., ; zanon, curtis, lockstone-binney, & hall, ) . other outcomes identified here, such as happiness, relaxation and destressing, challenge, and companionship, have been reported in previous qualitative studies of hiking (davies, ; kelly et al., ; lyu et al., ; richardson & mcewan, ; wensley & slade, ) . results reported here are derived directly from real-life tour clients, not experimental subjects. except for recovery from stress, outcomes identified here are very different from those reported in previous experimental psychology research on nature exposure. parameters such as improved attention and cognition, and reduced use of antidepressants, were not mentioned at all by participants in the current study, in contrast to previous experimental approaches (biedenweg et al., ; bratman et al., ; buckley, brough, a , b clough et al., ; frühauf et al., ; frumkin et al., ; niedermeier et al., ; oh et al., ; seymour, ; shanahan et al., ; wang et al., ; white et al., white et al., , wyles et al., ) . qualitative methods, such as the netnography used here, routinely provide opportunities to extend the range of parameters considered. from an economic or health-services perspective, at least some of our participants had experienced severe mental and social health obstacles, which they overcame by taking part in outdoor tours, at no public cost, with no side effects, and with benefits lasting months, years or longer. worldwide, poor mental health is increasingly prevalent and costly (mcdaid et al., ; patel et al., ) . chemotherapies and counselling are focussed on clinical cases. therapeutic opportunities from outdoor tourism are thus globally significant for individual wellbeing and quality of life, and for the economics of national healthcare systems. participants in this study were drawn from one particular demographic and socioeconomic group, namely urban and suburban women with families, in a developed country. this group experiences differentially high levels of depression, and social and family barriers to outdoor adventure (buckley et al., ) . the tourism products analysed here provide them with accessible and affordable outdoor experiences, and a social atmosphere and sense of community amongst the regular clients. these yield mental health benefits that range from happiness and relaxation, to psychological transformation and rescue; and social health benefits derived from carryover to other family members, whether or not those other members took part themselves. these are significant and valuable outcomes. mental health is always important for everyone, and everyone's mental health is suffering during the covid- pandemic (liu et al., ; mazza et al., ; mucci et al., ; pierce et al., ; vizard et al., ; wang et al., ) ; but women's mental health is under particular threat from disproportionate loss of income and employment, family stresses, and domestic violence, with reduced options for escape (brooks et al., ; graham-harrison, giuffrida, smith, & ford, ). 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recreation activities and barriers relative to societal trends how contact with nature affects children's biophilia, biophobia and conservation attitude in china ralf buckley is retired emeritus chair and president's international fellow, with a particular research interest in the psychological and conservation aspects of outdoor tourism founding director of wild women on top (www.wildwomenontop.com), and author of world class treks and natural exhilaration trek training®, wild women on top®, coastrek®. ethics protocol # / . key: cord- -hnvqvajx authors: speerin, robyn; needs, christopher; chua, jason; woodhouse, linda j.; nordin, margareta; mcglasson, rhona; briggs, andrew m. title: implementing models of care for musculoskeletal conditions in health systems to support value-based care date: - - journal: best pract res clin rheumatol doi: . /j.berh. . sha: doc_id: cord_uid: hnvqvajx models of care (mocs), and their local models of service delivery, for people with musculoskeletal conditions are becoming an acceptable way of supporting effective implementation of value-based care. mocs can support the quadruple aim of value-based care through providing people with musculoskeletal disease improved access to health services, better health outcomes and satisfactory experience of their healthcare; ensure the health professionals involved are experiencing satisfaction in delivering such care and health system resources are better utilised. implementation of mocs is relevant at the levels of clinical practice (micro), service delivery organisations (meso) and health system (macro) levels. the development, implementation and evaluation of mocs has evolved over the last decade to more purposively engage people with lived experience of their condition, to operationalise the chronic care model and to employ innovative solutions. this paper explores how mocs have evolved and are supporting the delivery of value-based care in health systems. models of care (mocs), and their local models of service delivery, for people with musculoskeletal conditions are becoming an acceptable way of supporting effective implementation of valuebased care. mocs can support the quadruple aim of value-based care through providing people with musculoskeletal disease improved access to health services, better health outcomes and satisfactory experience of their healthcare; ensure the health professionals involved are experiencing satisfaction in delivering such care and health system resources are better utilised. implementation of mocs is relevant at the levels of clinical practice (micro), service delivery organisations (meso) and health system (macro) levels. the development, implementation and evaluation of mocs has evolved over the last decade to more purposively value-based care was first discussed by berwick in as a triple aim of measuring health outcomes, improved patient experience and better use of health resources [ ] . porter added to the concept by including health professionals' experiences, seen as an important factor in achieving valuebased care. value-based care can be viewed as a continuum from high to low. 'high-value' care refers to care for which evidence suggests it confers benefit on patients, or probability of benefit exceeds possible harm, or, more broadly, the added costs of the intervention provides proportional added benefits relative to alternatives [ ] . are mocs supporting the shift to value-based care across the quadruple aim? does the evolution of mocs for people living with musculoskeletal conditions support the achievement of the quadruple aim? the paper will reflect on the changing attitudes towards healthcare by all stakeholders in the health system. consideration of some of the workforce requirements to deliver the health outcomes will be discussed, along with progress of consumer and clinical experiences. are better health outcomes being achieved? evolution of contemporary models of care for musculoskeletal conditions mocs were borne from frustration that traditional clinical pathways developed from evidence-informed healthcare were not being implemented for individuals, let alone across health settings and systems, resulting in unacceptable care variation and inequity in access to care [ e ] . evolving population health states, changing health requirements and expectations of the patient and their families, and changing approaches to care, mandated that a different approach to care planning, delivery and participation be taken. mocs were conceived to combine best practice healthcare and other services that are important to the person, population group or patient cohort across the continuum of a condition, injury or health event. mocs aim to ensure people get the right care, at the right time, by the right team, in the right place, with the right resources [ e ]. mocs for long-term conditions represent a shift from episodic provision of care to meet crisis situations, to care delivery across the disease continuum and life course [ , ] . the chronic care approach and the biopsychosocial model while the chronic care model proposed by wagner et al. in the s [ ] and the biopsychosocial model proposed by engel in [ ] are not new, the acceptance and integration of these personcentred and multidimensional approaches into care planning and delivery continues to evolve beyond the historic reductionist biomedical model. for the majority of long-term musculoskeletal conditions, application of the reductionist biomedical model has not been effective in improving outcomes [ e ] . thus, the chronic care approach and the biopsychosocial model are now central foci for mocs for long-term conditions. they are particularly relevant to musculoskeletal mocs, where target conditions are typically life-long and associated with persistent pain and functional impairment, and require interaction with a range of health services over decades from primary care to specialist medical and surgical services, even if intermittent. in chronic care, self-management support remains a fundamental component of effective care. operationalising these approaches within mocs requires consideration of the person's lived experience (incorporating biological, psychological and social sequelae), person-centred health outcomes and their experiences of care. recent debate in chronic pain care, for example, suggests that the biopsychosocial model of pain care is inadequately fit for purpose and needs to evolve further towards a sociopsychobiological moc [ ] . the inclusion of the person's lived experience of a condition(s), including the psychosocial sequelae, is now accepted as fundamental to designing, implementing and evaluating mocs. in order to understand and listen to those who know the condition best e the person living with the condition and their family/carer e several elements have been added to the development, delivery and evaluation of mocs in recent years [ ] . this a clear shift from mocs developed prior to the past decade or so. this shift has seen health teams, organisations and systems working to incorporate these concepts within musculoskeletal mocs through the use of multi-stakeholder networks, such as those in western australia and new south wales, australia (see https://ww .health.wa.gov.au/articles/j_m/ musculoskeletal-health-network and https://www.aci.health.nsw.gov.au/networks/musculoskeletal). while efforts were made in the past to include the lived experience, recent thinking and evidence has revealed that an even higher level of partnership between stakeholders is required to develop health services that meet the needs of those who access them as recipients of care [ ] . therefore, methodologies, such as clinical redesign [ ] , shared decision-making [ ] and co-design [ ] , have been used in recent years to facilitate this in-depth level of partnership. incorporating advice borne from experience can richly inform 'what' and 'how' care should be delivered in a local system. with the voice of the lived experience augmenting clinical experience and healthcare evidence concerning a particular condition, the resulting care is more likely to be acceptable to all involved and better reflect care that is high value [ e ]. critically, satisfaction of receivers of care is more likely to be associated with effective and active participation in their healthcare requirements [ , ] . measuring what matters to people: patient-reported measures patient-reported measures (prms) have evolved as a mechanism to report on and incorporate the patient voice in mocs. prms enable evaluation of healthcare, and can inform higher value-oriented changes to health services and health systems [ , ] . prms are commonly classified as two separate outcome measures: patient-reported outcome measures (proms) and patient-reported experience measures (prems). studies have shown that inclusion of proms enhances treatment decisions, patient satisfaction and subsequent adherence to agreed treatments [ , ] . systematic review evidence points to the likely benefit of using proms in healthcare [ ] . prems indicate the patient's perspective on issues, such as access to care, how they were approached and included in their treatment decisions [ e ]. while satisfaction surveys have long been a part of mocs, prems are relatively new with few tools to support their inclusion in clinical practice with local teams often developing their own. proms have the ability to identify issues that may not be elucidated during clinical assessments. there is appreciation now that background psychological issues, such as depression, anxiety and an individual's health beliefs and expectations, may impact upon recovery and their participation in care. this has led to specific proms, such as those that assess important person-centred impacts of living with a condition (e.g. in the management of people with back pain [ ] ) and others that focus more on generic issues that occur across healthcare needs, inclusive of social requirements [ ] . as such, proms have the dual capability of informing clinicians as to the whole of health impact of disease while at the same time providing a conduit via which previously unstated patient concerns may be addressed. proms and prems are important components to the quadruple aim of value-based care. innovation in development and implementation of models of care and service delivery as our understanding of the requisite components and practices for developing mocs and mosds evolve, innovation in development practices similarly evolves. like many other countries, early and appropriate conservative care for osteoarthritis (oa) remains underutilised in new zealand (nz). currently, nz has an outcomes framework for service development and commissioning for long-term conditions [ ] , including specific strategies for diabetes [ ] and healthy ageing [ ] . however, no frameworks or policies specifically exist for musculoskeletal healthcare. in response to this gap, in , the nz government allocated nzd million over years to trial and evaluate local healthcare programmes that aimed to improve access to early community-based interventions that provided contemporary clinical interventions and self-management support of people with musculoskeletal conditions e the mobility action programme' [ ] . an additional $ million (new zealand $) was allocated to address access issues to joint replacement surgery [ ] . the aim of the mobility action programme is to trial, evaluate and commission effective and sustainable programmes for broader dissemination across nz in the future. why a co-design approach was needed in new zealand for an oa model of service delivery despite these investments, a national framework to align the health system with best practice recommendations for musculoskeletal conditions does not exist prompting a call to action for an oa moc for nz [ ] . furthermore, there is currently no guidance for health service delivery for decision-makers, such as planners, coordinators or funders, about which interventions for oa offer the greatest perceived value in the nz health system. for oa, this decision can be particularly challenging given that there are many interventions to choose or recommend in a national-level service model, and because implementing recommended oa care is typically complex and influenced by many interdependent barriers and facilitators across the health system [ , ] . for these reasons, adopting the principle of co-design with stakeholders from across the sector in reform efforts is essential, including the perspectives of people with a lived experience of the condition and vulnerable groups, to ensure appropriate consideration of context' and fit' [ , ] . strong evidence points towards incorporating context, that is, the environmental conditions which influence the barriers and enablers of implementation [ ] ) into the decision to adopt or commission an intervention for implementation [ , ] . in particular, establishing the fit' of established or emerging interventions within the nz context could help to enhance implementation of oa care by more closely aligning intervention performance with what stakeholders want. alignment of recommendations for oa care will potentially reduce healthcare waste [ ] . for example, interventions that align closely with decision-makers' decisionmaking criteria, such as intervention cost, accessibility and effectiveness, and evidence about interventions' performances on these criteria could enhance implementation efforts and better align with system policy priorities. developing national recommendations for oa care is a complex endeavour and should ideally represent the views and opinions of the people most relevant to oa care in a particular context. in nz, this context includes not only people across the community living with oa, but also specifically m aori healthcare advocates. they need to work in tandem with healthcare providers, policy-makers and oa research and clinical experts working in the various care settings. however, these eclectic stakeholders typically make complex decisions involving many considerations, or criteria, which often compete. weighing up these different criteria to reach a decision should ideally occur through a transparent, trustworthy and fair process. approaches for reaching consensus include, for example, verbal agreement, delphi surveys, nominal group technique and consensus development panels (e.g. deliberative dialogues) [ ] . some limitations of these methods include: ( ) decision-making criteria may not be explicit and decisions may be made without appropriate time for reflection; ( ) decision-makers' preferences or values are typically implicit; ( ) new evidence, ideas or alternative choices may invalidate previously reached consensus and ( ) engagement can be limited, particularly among those with a lived experience of a health condition. multi-criteria decision analysis (mcda) is a systematic, transparent and fair approach to decision-making that can address these important considerations [ ] . mcda structures decision-making by incorporating subjective and objective data in a systematic and transparent process that identifies and weighs multiple evaluation criteria in order to prioritise different healthcare interventions, policy options or alternatives [ ] . this structured, systematic approach is a defining characteristic of mcda and helps to overcome mental shortcuts (often employed in complex decisions, e.g. gut feeling') which can lead to systematic mistakes, poor decisions, and ultimately, poor decision-making credibility [ ] . the advantages of mcda include: i) explicit evaluation criteria enforces transparency, accountability and fairness; ii) scalability e the ability to prioritise new or emerging interventions without capturing stakeholders' preferences for these interventions each time and iii) efficiencies in design and deployment streamline decision-making allow for broader and more meaningful engagement with a diverse range of stakeholders. in recent years, mcda has become widespread in healthcare research [ , ] . for example, it has been used to explore the preferences of people with oa concerning physical activity [ ] , patients' preferences for the use of medicines [ ] , healthcare providers' treatment choices for people with oa [ ] and policy-makers' and clinical decision-makers' preferences for intervention choice [ ] . it has not been applied previously to inform a cross-sector, consensusbased mosd for people with oa. how has mcda been applied in the nz context for oa care? through a qualitative study in e , multidisciplinary and cross-sectoral stakeholders in nz (people with the lived experience of oa, healthcare providers, policymakers and oa clinical and research experts) identified nine criteria for selecting or recommending oa interventions in the nz public health system: accessibility, active versus passive interventions, appropriateness, cost, duration, effectiveness, quality of evidence, recommendation and risk of harm [ ] . criteria were organised according to the guidance for mcda [ ] , for example, selecting nonredundant and non-overlapping criteria. the criteria were then categorised into levels' describing their performance. for example, the criterion effectiveness' was categorised into high, moderate and low levels of performance using the standardised mean difference. choicebased surveys were used to quantify people's preferences for the criteria, that is, their relative weights. interventions were then rated on the performance levels of the criteria, sourced from clinical guidelines [ ] , local data and a nationally representative panel of experts in oa management in nz. the final step involved combining the preference weights and intervention ratings together to calculate a total performance score for each intervention. digital and electronic health solutions digital health systems now offer unprecedented capabilities to health systems and consumers in data collection, delivery of information and access to health services. access is enhanced through realtime access to care (e.g. through telehealth) and digitally based tailored care (e.g. through adaptive mhealth platforms). the healthcare opportunities offered by digital systems and the ubiquitous use of digital platforms globally, such as mobile phones, rationalise digital health systems as a key strategy for health system strengthening [ ] . these technologies have appeal, particularly for younger people [ ] , and also provide opportunities to close care disparity gaps that exist due to geography and socioeconomic circumstance, and allow for electronic recording of care access and delivery over time. while there has been an uptake in telehealth and mhealth solutions for some chronic conditions in the past decade, including opportunities for musculoskeletal and pain care [ ] , system-wide adoption in musculoskeletal care outside hospitals has been slow, despite promising opportunities. many reasons can be attributable to the slow uptake, in particular the major gap between innovation and testing and appropriate scale-up into systems [ ] . there is an opportunity to close innovation-adoption gaps by better integrating digital solutions into the design of mocs. in the case of telehealth, one reason is the belief that physical clinical assessment is paramount to diagnosing and monitoring a musculoskeletal condition. perhaps this will change following the covid- pandemic, which forced clinicians to adopt these tools as part of routine care. in the case of electronic medical recording, the required allocation of significant resources in settings (out of hospital acute care) that have traditionally not been seen as important is limiting uptake. however, these systems can add value to better utilisation of clinical time, ease of recording of prms and greatly assist in evaluation efforts [ ] . how well are models of care accepted in health systems and their services? it has long been accepted and expected that a health system uses structures and processes to create an integrated care environment that is appropriate for the population it serves [ , ] . mocs, when developed as described in this paper, have been a fundamental means of enabling this to happen in some jurisdictions and care settings [ , ] . for example, national health policies for non- findings from this activity could be used to inform recommendations in a national mosd for oa, which outlines those interventions that offer the greatest perceived value to nz stakeholders. the mcda process enabled the views and perspectives of all stakeholder groups, particularly people living with oa and m aori advocates, to be respected and equally considered. the development, implementation and evaluation of mocs for musculoskeletal conditions requires equal partnerships between those with lived experience of the disease/condition and their carers, health professionals across all disciplines, service resource personnel, researchers and policy-makers in jurisdictions. enhanced decision-making methods, such as multi-criteria decision analysis, can be used to inform more robust and trustworthy health policy decision-making through broader and more inclusive engagement of people with lived experience; this could help policy-makers identify better value-based care options. there is an urgent need for further uptake of digital technologies to support implementation of mocs. communicable diseases refer to the need to develop and implement mocs to drive health system strengthening [ ] . the national health service in the united kingdom is a good example where mocs have been the main drivers of change including in the development of strategy to turn attention to value-based healthcare [ , ] . acceptability of mocs by stakeholders from across the health system in australia was validated in a large qualitative study [ ] . informants identified the value of mocs in translating evidence to policy and practice and supporting system-wide health transformation. implementing models of care to support value-based care when mocs are developed as described in this paper and a quality improvement cycle is used, such as an established framework for evaluation [ ] , they can provide clear evidence for health systems and policy-makers when making decisions regarding equitable use of resources that will optimise health system outcomes across the quadruple aim for value-based care. low back pain, identified as the single greatest contributor to the global burden of disability since [ ] represents an important focus for health systems to realign to deliver value-based care. currently, health systems deliver too much low-value care and too little high-value care for low back pain. recent reviews have identified key challenges for health systems in delivery of high-value care for low back pain and pain care in general [ , , , ] . these include the financial interests of pharmaceutical and other companies; inflexible payment systems that favour medical care over patients' self-management; and deep-rooted biomedical traditions and beliefs about pain among physicians and the community at large. authors have argued for system-level reform strategies, such as the implementation of mocs, to shift resources from unnecessary, low-to high-value care and that such endeavours could be cost-neutral and have widespread impact. evidence is building concerning whether mocs can support value-based care. health systems are now using mocs to inform strategy concerning value-based care [ , ] . for example, musculoskeletal mocs for people living with osteoarthritis and those experiencing fragility fractures are included in the suite of services for value-based care initiatives in australia [ ] , while in canada, a national approach to hip fracture care has been developed [ ] . the new south wales health system in australia is now into the fourth year of formally implementing value-based care, with mocs remaining at the forefront of decision-making on each tranche of implementation [ , ] . multidisciplinary team-based care as an enabler to implementing musculoskeletal models of care healthcare transformation, designed to improve access and quality of care while containing cost, is a worldwide priority [ e ], aligned with value-based care and enabled through mocs. many countries have responded by enabling existing healthcare professionals to work to their maximum scope (advanced scope of practice [ e ], which has also been articulated as an enabler to implementing mocs [ ] . historically, this approach has worked to address shortages in available healthcare practitioners in remote and rural areas and on the front line to triage injured soldiers during wartime. more recently, advanced practice roles have been implemented as part of new interprofessional models of team-based musculoskeletal care. these innovative mocs require close collaboration and communication among healthcare providers, integration across care sectors (private/ public, hospital/primary/community based) and funding models that enable and promote evidencebased care across the full continuum of care [ ] . while people with musculoskeletal conditions access a variety of medical and surgical specialties, there is a need for other non-medical health professionals to be involved in order to access high-value care; for example, supporting the person's understanding of and addressing issues, such as psychological needs, co-morbidities, weight loss and physical activity in osteoarthritis care. nurses and allied health professionals, such as physiotherapists, dieticians and others, are key members of a true multidisciplinary musculoskeletal care team. not surprisingly, the high cost and volume of people, who require improved access to musculoskeletal care in the primary care sector, has resulted in the emergence of the new inter-professional service models inclusive of health professionals with advanced scope of practice skills such as nurse practitioners and physiotherapists who have had advanced training in musculoskeletal healthcare [ , , e ] . as demand for musculoskeletal health services increase, mocs will increasingly recommend alternate and innovative workforce models to ensure timely access to care and high-value service delivery. in high-income settings, these examples of new cadres who are educated and authorised to function autonomously and collaboratively in advanced and extended clinical roles may help to achieve some of the quadruple aims of value-based care. these may include reducing wait times in emergency departments, triaging to surgical consult for total knee or hip joint replacement, re-fracture prevention assessments and investigation, and performing as the lead health professional in supporting people presenting with acute low back pain [ e ]. ongoing evaluation of clinical, economic and patient experience outcomes will be important to maintain momentum in optimising workforce configurations. in lower resourced settings, building capacity among appropriately skilled and trained community health workers will be important to implementing mocs and avoiding catastrophic out of pocket expenditure for citizens, such as integrated care services for older people [ ] and communitybased spine care [ ] . an important aspect of value-based care and involvement of multidisciplinary teams is health professional experience. to understand their experience, there is a real need to develop a standardised way of measuring elements that are meaningful to health professionals in the delivery of care. an example is the national health service in the uk that could be developed for use across jurisdictional borders. see at: https://www.nhsstaffsurveys.com/caches/files/st _core% questionnaire_final_ .pdf. as the acceptance of mocs as levers for system reform becomes more widespread, there will be an increasing need for implementation support within health systems and sharing of experiences. implementation support can occur at different levels: from local support for an mosd, to sub-national, to national support for system wide implementation efforts, through to global-level support for multinational implementation. along this continuum, the level and focus of support may vary from comprehensive local support (e.g. organisational site visits) through to principles or guiding actions for countries to work towards and self-evaluate. local and sub-national implementation support initiatives typically involve assisting organisations across a health system to implement an moc through an operational-level mosd, usually adapted to the local context. for example, in new south wales, australia since , there has been increasing support for implementation of several mocs for the healthcare needs of people with musculoskeletal conditions, including osteoarthritis, secondary fragility fracture prevention, hip fracture care, acute low back pain, and children and adolescents living with rheumatologic conditions. this has been achieved initially through a clinical network working with government in supporting local organisations to develop business cases for implementing the mocs and the provision of seed funds to enable pilot implementation initiatives with common evaluation frameworks. implementation scale-up across the there is an urgent need to develop a tool that measures health professional experience across the domains of job satisfaction, burnout, how adverse events are handled, how engagement up and down the hierarchy occurs, their ability to provide care that incorporates all the impacting issues that a person presents for care is experiencing across biopsychosocial areas, and their capacity to influence change within the health service. funding and implementation of team-based mocs that allow for local adaptation in rural and remote as well as urban areas that can be scaled and spread are essential. ongoing evaluation of advanced practice nursing and allied health professional mocs will be important to maintain and optimise workforce configurations. system was achieved through integration of the mocs for osteoarthritis and secondary fragility fracture prevention within a larger whole-of-system reform initiative e the 'leading better value care' programme: https://www.health.nsw.gov.au/value/lbvc/pages/default.aspx [ ] . the south west england mocs support network is an example of an online community of practice formed to support implementation of mocs across primary care in the south west of england and beyond (https://modelsofcare.co.uk/). multiple other sub-national implementation support programmes also likely exist, although currently no repository exists to share implementation experiences. international efforts to support the implementation of mocs and mosds across countries focus on specific service models or offer guidance that is transferable across conditions. examples of specific service models include: the global fragility fracture network (https://www.fragilityfracturenetwork.org/) supports implementation of best practice and localised mocs for people with fragility fractures across the continuum of care through formal education opportunities and peer mentoring. this includes efforts for health professionals working with the patient cohort at presentation with fracture to peri-operative care, to rehabilitation and to secondary fracture prevention. the good life with osteoarthritis in denmark (gla:d®) (https://www.glaid.dk/english.html), now implemented in denmark, canada, china and australia, with further countries joining (switzerland, new zealand and austria) [ ] . the mosd provides specific implementation guidance for physiotherapist-led exercise and education for people with hip and/or knee osteoarthritis. the international osteoporosis foundation capture the fracture® programme (https://www. capturethefracture.org/) [ ] facilitates the implementation of coordinated, multi-disciplinary service models for secondary fragility fracture prevention. the programme offers multiple implementation resources to support countries implement the programme and evaluate the scale of implementation achieved (https://www.capturethefracture.org/resources). the global spine care initiative (https://www.globalspinecareinitiative.org/) [ ] supports the implementation of local spine care services in low-and middle-income countries. it is based on eight principles that consider implementation from the micro to macro contexts. the clinical and health economic outcomes of the model are yet to be established. a framework (the 'framework'; fig. ) to support implementation of any musculoskeletal moc was developed in , empirically derived with input from stakeholders across countries [ ] . the framework guides those tasked with implementation in a health system to consider and evaluate the following domains: -implementation readiness -best practice approaches to support implementation -evaluation. the framework is now endorsed by peak international organisations and has been used internationally to support development, implementation and evaluation of mocs (see fig. ). the majority of public-facing mocs for musculoskeletal conditions have been developed and supported for implementation in high-income countries. while there are some initiatives occurring in low-and middle-income countries [ , ] , there remains a need to support development and implementation of musculoskeletal mocs in low-and middle-income countries that supports, rather than threatens, fragile health systems [ , ] . recent research, for example, has confirmed the suitability of the chronic care model for low-and middle-income settings, but identified that some adaptation and expansion is required for low-resource settings [ ] . the who integrated care for older people (icope) model supports countries at all stages of maturity to consider actions required to realign health systems towards the needs of older people, including their mobility and musculoskeletal health [ ] . implementation tools are now available to support the implementation of icope internationally in health services and health systems [ ] . systematic reviews have reported a range of factors that have been identified as barriers and enablers to implementation of mocs in health services and health systems [ , e ] . as outlined in the framework (fig. ) , consideration of these factors and others that are relevant to the local context are essential in approaching any implementation effort. system-level mocs and their operational-level mosds are one of many tools that support the translation of evidence into system (macro)-level (e.g. policy), service (meso)-level (e.g. programme implementation) and clinical (micro)-level (e.g. practice) changes [ ] . however, all too often evidence translation initiatives end with short-term and non-recurrent resourcing, resulting in multiple shortterm trial reforms, programmes or pilots. these then often lead to reform fatigue among those tasked with implementation and monitoring [ ] . on this background, appropriate evaluation of mocs is an essential component of supporting long-term implementation and sustained reform and quality improvements efforts in health systems. local system evaluation is critical [ ] , recognising that outcomes between settings may not necessarily be comparable; for example, between high-and lowincome economies, or even at the sub-national level between jurisdictions with geographic differences that can impede access to services and/or expert services. evaluation of mocs must be pragmatic, flexible to a dynamic health system, respectful of local contextual issues and meaningful to intended end users. the parameters of evaluation should be codesigned with decision-makers and end users to ensure the outcomes are meaningful, useable and contemporary [ ] . the perspectives of people with lived experience of a health condition are also critical to ensure meaningful concepts are measured [ ] . evaluation approaches need to consider design and methods, target levels of the health system and outcomes. while 'effectiveness' evaluation (research) remains essential to advancing health innovation, identifying high-value care and minimising health waste, this mode of evaluation may be less relevant and feasible at the stage of implementing mocs in health systems. by definition, the components of an moc should be evidence based [ ] ; suggesting that evaluation of effectiveness is less of a priority for the downstream evidence translation phase of implementation. the necessary structured and rigid design of gold standard effectiveness research designs, such as the randomised controlled trial (rct), may collide with the dynamic nature of health systems and health services and inadequately reflect outcomes of the broader population health state. in particular, rcts may often exclude people with multi-morbid health states, which now reflect the norm rather than a subgroup [ ] . researchers are it is timely to now consider multi-morbidity in models of care (mocs), given the prevalence of multi-morbidity of non-communicable diseases with musculoskeletal conditions commonly being prevalent. evolution of future mocs needs to more explicitly consider multi-morbidity and how condition-specific or multi-morbidity mocs can support delivery of high-value care. while there are some examples in recent years to support the development and implementation of some musculoskeletal mocs in low-and middle-income countries, for example, fragility fracture and spine care, there is a dire need to adapt and support implementation of moc in a manner that is suitable for fragile health systems. more research is required concerning health and economic outcomes achievable through implementation of mocs in order to drive further health system improvements globally. the approach proposed by jessup and colleagues is a good starting point [ ] . starting to apply more innovative trial designs to deal with this challenge and focus specifically on implementation trial designs [ ] , although more experience and work is required to apply such methods across services or across a system. the incompatibility between rcts and health systems research is particularly relevant in the context of mocs with a strong ehealth component [ ] , where evaluation approaches other than effectiveness designs are recommended and supported by guiding frameworks [ , e ] . these evolving frameworks could feasibly be applied beyond ehealth, with many of the guiding principles already reflected in a framework developed to specifically guide evaluation of musculoskeletal mocs [ ] . collectively, the framework advocates for continuous cycles of mixed-methods evaluation (or formative evaluations), aligned with a process evaluation approach to iteratively understand how implementation could be optimised in a given context and be responsive to changing circumstances [ ] , before initiating a summative (impact) evaluation. the framework also suggests that evaluation should not be based on single outcomes, but consider a multidimensional approach to defining 'success', 'performance' or 'benefit', achieved through mixed-methods approaches that consider outcomes relevant to the consumer (e.g. proms and prems) and the health system [ , ] . the importance of emphasising qualitative research exploring stakeholders' perceptions and attitudes towards implementation feasibility, acceptability and sustainability is widely proposed [ , ] . evaluation of mocs or downstream mosds can be targeted at different levels of the health system. an evaluation hierarchy, or pyramid, has been proposed, which suggests evaluation can be targeted at one or more of three levels (see fig. ) [ ] : ) specific components of an moc or mosd (e.g. a specific clinical behaviour, work cadre or self-management strategy); ) at the programme level (e.g. where a specific health improvement programme is implemented, such as the gla:d® programme [ ] or capture the fracture® initiative [ ] ) or ) at the whole-of-system level (e.g. the system wide impact of implementing an moc or multiple service models across a whole system such as the who icope approach [ ] ). most implementation and evaluation efforts occur at the base of the pyramid, while the least occurs at the system level [ , ] , likely reflecting the challenges associated with whole-of-system evaluation endeavours. evaluation at the system level, however, remains of critical importance and underscores the need for appropriate health surveillance infrastructure and systems [ , , , ] , particularly in low-and middle-income countries [ ] . as implementation of mocs evolve and evaluation systems become more sophisticated, the need for a pyramid inversion will become greater. indeed, many jurisdictions are now emphasising the need to reorient evaluation towards a whole-ofsystem lens in order to build a better picture of overall system functioning and performance against reform targets, inclusive of an approach that integrates patient, clinician and system performance outcomes [ , ] . while system-and service-level integration of proms and prems is challenging, as identified in a recent systematic review of barriers to implementation [ ] , recent data from new south wales, australia, point to the feasibility of measuring proms across a system though electronic platforms [ ] . in order to achieve integrated measurement of patient and clinical outcomes (micro level), service-level (meso) outcomes and system-level (macro) outcomes, co-design with end users of the evaluation (typically policy-makers, health administrators/mangers and funders) is needed on a background of a lens to healthcare planning and delivery that prioritises 'value' over 'volume' [ , ] . infrastructure and governance to enable consistent and systematic measurement is essential and enabled through registries to capture proms and prems, agreed performance indicators for health services [ , ] and linked data systems [ ] . in the context of mocs specifically, the recent evaluation framework guides measurement of 'success' of a musculoskeletal moc in a health system and recommends a range of outcome domains should be considered (fig. ) [ ] . this paper has revealed that in the past decade, many positive influences have supported the concept of utilising mocs to support value-based musculoskeletal care. the evidence is clear that the development, implementation and evaluation of mocs must rely more on the involvement of those with the lived experience. their involvement must be in collaboration with those who provide care, their managers and funders. collectively, the advice from those intimately involved whether through personal experience of musculoskeletal diseases or conditions, or clinical practice, or research of the conditions, or through management and funding leads to all elements of the quadruple aim being achieved, as described by porter in [ ] . however, challenges remain that hinder widespread implementation in many areas of the globe, with many being directly attributable to some specific embedded practices [ , e ] . fig. summarises challenges commonly experienced at the various levels of the health system. for mocs to be even more successful in guiding clinical practice global strategies such as choosing wisely need to be encouraged and supported by governments internationally [ e ]. in low-to middle-income countries, there is a policy swing that now acknowledges the contribution from non-communicable diseases to the burden on population health [ ] . for example, osteoporotic fractures in asia are predicted to be higher than seen elsewhere in the next decade [ ] . future mocs for healthcare will need to be incorporated into government policy concerning housing, education and employment. the momentum for such change is evidenced by the recent us document encouraging the addition of social care to all healthcare considerations [ ] . evaluation of mocs is a critical enabler to supporting sustainable implementation and resourcing of mocs. shifting from a reliance on effectiveness' evaluations to evaluation approaches that better align with multiple domains relevant to implementation is important. outcomes should be meaningful and useable to intended end users and decision-makers, informed through purposive co-design. evaluation at the system level, rather than at the programme level, may better support implementation at scale. in summary mocs are 'adopting evidence-based clinical pathways and protocols, aligning incentives, effectively managing resource, continuously monitoring and improving performance, and investing in supporting information technologies' [ ] . their use is to encouraged more and more across the globe. this paper was developed without specific funding for any of the 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date: - - journal: asian j soc psychol doi: . /j. - x. . .x sha: doc_id: cord_uid: xhusfth the present study examines the psychological impact of severe acute respiratory syndrome (sars) by exploring the coping strategies and health behaviors enacted in response to the sars epidemic. hierarchical linear regression indicated that the use of wishful thinking in response to the threat of sars was related to both avoiding public places and avoiding people perceived to be possible carriers of the sars virus, but was not associated with the use of more adaptive health behaviors, such as using disinfectants and hand washing. conversely, those who reported engaging in empathic responding in response to the threat of sars were both less likely to report avoiding people perceived as being at a high risk for sars and more likely to report engaging in effective health behaviors. support seeking was not a significant predictor of the health behaviors examined in the present study. results are discussed in terms of coping with health threats and health promotion. increased understanding of severe acute respiratory syndrome (sars) is necessary for researchers, health-care providers and the general public alike. if we are to prevent the spread of disease and reduce its far-reaching effects, there must be knowledge of not only the virus itself, but also of the social and psychological sequelae of the disease. furthermore, if we are to prevent the spread of disease, study of the impact of sars cannot be limited to those relatively few who have actually contracted sars; it must also include the general public's reactions to the disease. that is, how has the general public reacted psychologically, socially and behaviorally to news of the disease? to what extent does the general public feel threatened by the possibility of the disease spreading, and how do they cope with these fears? do their ways of managing their fear of sars affect their ability to engage in adaptive health behaviors? understanding ways in which the general public's coping with their sars-related fears affects their ability to engage in preventative health behaviors is critical. such knowledge would potentially be applicable, not only in the face of the sars outbreak, but also in general health promotion. one of the most significant effects that sars has had on the general public has been a change in health-related behaviors (bray, ) . these changes were multi-faceted and encompassed everything from frequent hand washing and the use of face masks to complete isolation from the outside world. as evidenced, in part, by the economic fallout of the disease, a common behavior change, particularly in affected areas, was to avoid public venues such as restaurants, marketplaces and airports. although this sort of behavior is undoubtedly associated with decreasing one's risk of exposure to the virus, it was associated with significant economic costs without a correspondingly large reduction in risk (cdc, a; who, a) . another behavioral response to reports of the outbreak was to limit contact with people perceived to be at risk for the virus. this included people who displayed symptoms of the common cold (e.g. coughing or sneezing), workers in the health-care profession, and individuals assumed to have a high likelihood of having sars by virtue of their ethnicity, nationality, or recent travel history. given that the largest outbreak of sars occurred in asian countries, north americans may have grouped those of asian ancestry within this last category. similarly, being canadian (or torontonian in particular) was viewed by some as evidence of being high risk by those outside of canada or north america. avoiding people perceived to be at risk for sars was unlikely to be effective from a health-care perspective, and certainly can be viewed as detrimental from a psychological and social perspective. such behaviors no doubt lead to ostracism of those believed to be at risk. when associated with certain ethnic or racial groups, the obvious result is racism. a third possible behavioral response to the outbreak was to engage in preventative health behaviors as prescribed by the world health organization (who), the center for disease control (cdc) and a variety of other health-care units, hospitals and individual health-care providers (e.g. cdc, a cdc, , b cdc, , c nbc .com, ; who a) . suggestions were widely publicized via television, websites, and lay-oriented news reports indicating that behaviors such as taking more care with cleanliness, using disinfectants, washing hands more regularly, eating well and getting enough sleep were reasonable and useful preventative measures in which to engage. not only were such strategies likely to be helpful in limiting the spread of sars, they also have few negative side effects at both an individual and societal level. although numerous models for the prediction of health behaviors have been put forth (fishbein et al. , ) , few of them consider threats to health as a potentially stressful experience, as is likely to be the case with the sars epidemic. when individuals are exposed to media reports of sars, they may experience an increase in anxiety and threat associated with those reports. how these individuals cope with that threat may either facilitate or inhibit their engagement in the aforementioned health behaviors, which, in turn, may directly alter the risk of disease. examining the role of coping in health behaviors may inform public health efforts to encourage protective health behaviors. models of stress and coping with disease (lazarus & delongis, ; delongis & o'brien, ) provide a useful framework through which to understand the ways in which threats to health, coping and health behaviors are related. these models emphasize the transactional or interactional nature of the stress and coping process and suggest that when people are exposed to stressors, such as news of the sars epidemic, an evaluative thought process is triggered in which they consider whether or not the stressor is a threat to their own well-being. this process in turn prompts an evaluation of options for coping with the perceived stressor. this, then elicits an array of coping behaviors in an attempt to manage various aspects of the stressor. the literature on coping with illness suggests a number of strategies for dealing with illness-related stressors that might meaningfully be applied to the current sars crisis (o'brien & delongis, ) . these include wishful thinking, support seeking and empathic responding. wishful thinking refers to the individual's efforts to cognitively escape from or avoid the situation by wishing, fantasizing or hoping it goes away or is somehow over. wishful thinking has been found to be associated with negative outcomes, such as depression, anxiety, increased stress-related physical symptoms, and poor adjustment to illness (penley et al. , ) . however, we know of no study examining the role of wishful thinking in the implementation of health-related behaviors. support seeking involves efforts to gain emotional, informational or tangible support from others. although there is a strong and consistent association between social relationships and positive health outcomes (coyne & delongis, ; house et al. , ) , there has been little research examining the association of support seeking with engaging in protective health behaviors. finally, empathic responding is a mode of coping that has recently begun to receive attention in the stress literature. individuals engaging in empathic responding try to understand what others are experiencing and offer support and assistance. empathic responding may provide benefit to the recipient of these efforts (o'brien & delongis, ), but, perhaps even more critical, evidence suggests that engaging in empathy and support can provide benefits for the provider as well (brown et al. , ; kramer, ; visitini et al., ) in terms of improved psychological well-being, physical health, and relationship satisfaction. however, we are aware of no research examining the relationship of empathic responding to health behaviors. we sought to examine ways in which the perception of the threat of sars was related to coping and, in turn, how coping was related to health behaviors. understanding the ways in which coping is related to engaging in health behaviors may be critical to encouraging effective health behaviors in the face of health crises such as sars. it was expected that perceived threat of sars would be associated with higher reported frequency of engaging in a variety of coping strategies in an attempt to deal with feelings of threat and fear. specifically, these were expected to include wishful thinking, support seeking and empathic responding. finally, we expected specific coping strategies to be instrumental in facilitating specific health behaviors. that is, given the avoidant nature of wishful thinking as a coping strategy, it seemed reasonable to assume that the use of such a strategy for managing the threat of sars might be associated with avoidance-type health behaviors. here, we expected © blackwell publishing ltd with the asian association of social psychology and the japanese group dynamics association higher levels of wishful thinking to be associated with higher reports of avoiding both public places and individuals perceived to be at risk for sars. finally, empathic responding involves considering the stressful experience not only in terms of one's own feelings and well-being, but also in terms of other's well-being. given the use of empathy, one might be less likely to consider other people as objects to be avoided but rather as people needing and requiring care. without the impulse or need to engage in avoidant behaviors, efforts for engaging in health behaviors may be turned towards more preventative and effective health behaviors such as hand washing. no specific hypotheses were made regarding the relation of social support seeking to health behaviors. although we expected those reporting higher perceived threat of sars to engage in higher levels of support seeking, we had no clear expectations regarding which health behaviors might be facilitated by such a coping strategy given the paucity of previous research. data were collected through an online questionnaire linked to a number of websites, including psychology websites, the laboratory websites of the second and fourth authors and their colleagues, and advertisements on google, a search engine. the google advertisement popped up when individuals searched for information on 'sars'. it asked viewers to complete an online questionnaire about how they were coping with the sars threat. all of the links first took potential participants to an informed consent page. once they indicated they had read the consent form and consented to participate, they were taken to the questionnaire. the questionnaire was written in english. data included here are from questionnaires completed between june and september . sample. seventy-one percent of the sample resided in canada, % of these in toronto. other countries of residence included china, costa rica, germany, hong kong, singapore and the usa. approximately % of the respondents were living in a sars-affected area. fortythree percent reported canada as their country of birth. the majority of the respondents (rs) were under years of age ( %), female ( %) and had over years of education ( %). approximately half the sample was composed of students. other occupations included healthcare workers, engineers, psychologists and office workers. ethnicity was not included due to the difficulties in coming up with a suitable classification system that could be used in a worldwide survey. the sars collaborative research group (including the second and fourth authors) jointly developed the main questionnaire. only those variables related to the current study will be discussed. some of the measures used in the present study were from this original questionnaire (the health behaviors component, demographic information and the support seeking and wishful thinking coping items). other measures (perception of sars threat, empathic coping items, and state anxiety) were added to the questionnaire specifically for use in the study described here. state anxiety. feelings of current anxiety were assessed through an updated version of spielberger et al. 's ( ) measure of state anxiety. respondents were asked to rate their current feelings related to sars on a -point scale ranging from 'not at all' to 'very much so'. the scale consisted of items including such items as 'i feel tense', 'i feel upset', 'i feel nervous'. consistent with previous reports (gaudry et al. , ) internal reliability of the scale in the present study was high (cronbach's alpha = . ). perception of sars threat. participants were asked to rate the extent to which the following statements were true for them at the current moment on a -point scale ranging from 'not at all' to 'a great deal'. the five items were; 'i don't think i could get sars', 'i feel nervous about getting sars', 'sars is threatening my health', 'i don't feel worried about getting sars', 'my daily routine has been disrupted due to thoughts about sars'. internal reliability of the scale was moderate (alpha = . ). ways of coping. items were chosen from the ways of coping questionnaire (folkman et al. , ) that tapped strategies for coping that were applicable to coping with the threat of sars. items from two subscales were included in the present study (wishful thinking and support seeking). in addition, items from the relationship-focused coping scale (empathic responding; o'brien & delongis, ) , which were applicable to the current study, were also included. instructions to respondents for the coping items were 'to what extent have you managed whatever concerns or fears you might have about sars in each of the ways listed below?' wishful thinking. rs were asked the extent to which they had managed their concerns or fears about sars through 'wishing sars would go away or somehow be over with' on a -point scale ranging from 'not at all' to 'a great deal'. support seeking. support seeking was assessed by asking rs to rate the extent to which they had managed whatever concerns or fears they had about sars by 'talking to someone to find out more about sars' and 'talking to someone about how i was feeling about sars' on a -point scale from 'not at all' to 'a great deal'. the reliability of the scale was high (alpha = . ). empathic responding. respondents were asked to report the extent to which they had helped others who might be concerned about getting sars on a -point scale ranging from 'not at all' to 'a great deal'. the four items included: 'tried to understand the other person's concerns about sars', 'tried to understand how the other person felt about sars', 'tried to help the other person(s) by listening to their concerns about sars', and 'tried to help the other person(s) by doing something for them'. consistent with past research (o'brien & delongis, ) , reliability of the scale in the present study was high (alpha = . ). health behaviors. as noted above, items were taken from the web questionnaire on sars developed by members of the sars collaborative research group . instructions to respondents for the health behavior items were 'to avoid getting sars, i have personally…' and specifically for the avoiding people subscale, 'how likely are you to avoid the following people?' avoiding public places. respondents were asked to identify behaviors in which they had engaged to avoid getting sars. the possible behaviors were: avoided travel to sarsinfected areas, avoided eating in restaurants, avoided shaking hands, avoided travel in taxis, avoided travel on subways or commuter trains, avoided eating in food courts/food centers, not gone to work/school, avoided large gatherings of people, avoided particular types of people, and avoided travel by airplane. the number of responses, based on the response alternatives checked, was summed for a final scale. reliability of the scale was moderately high (alpha = . ). avoiding people. respondents were asked to indicate, using a -point scale ranging from 'very unlikely' to 'very likely', the degree to which they avoided people who might be perceived as having a higher risk of having been exposed to the sars virus. the items were: a person you know has just come from an area infected with sars, a person who has a fever, a person who sneezes, a person who looks unwell, a health-care worker, a person who is coughing, a person who you think might possibly be from an area infected with sars, a person who has a family member who has come down with sars, a stranger wearing a surgical/hygiene mask, and a stranger not wearing a surgical/hygiene mask. the final scale consisted of the sum of the checked alternatives. reliability of the scale was high (alpha = . ). taking health precautions. respondents were asked to identify behaviors in which they had engaged to avoid getting sars. these eight health behaviors included: wearing a mask, washing hands more often, taking more care about cleanliness, using disinfectants, eating a balanced diet, exercising regularly, taking an herbal supplement, and making sure they got sufficient sleep. the number of items endorsed was summed into the 'taking precautions' scale. reliability of the scale was moderately high (alpha = . ). table presents descriptive statistics for the study variables. t -tests were conducted examining gender differences in the study variables; the only significant difference to emerge was that women in the study were significantly more likely to report seeking social support than were men ( t ( ) = - . , p < . ). t -tests were also conducted to examine differences between those participants living in sars-affected ( n = ) versus sars-unaffected ( n = ) areas. no significant differences emerged on any of the study variables. the most significant time for the sars outbreak was before mid-july (who, b) . however, given that data collection continued until september, t -tests were conducted examining whether there were significant differences between responses reported before and after mid-july on the study variables. there were no significant differences due to time of data collection (adjusting for the number of tests conducted). table also presents the bivariate correlations among study variables. perception of sars threat was significantly related to reports of both coping (wishful thinking and support seeking) and health behaviors (avoidant behavior, avoiding people perceived to be at risk for sars and taking precautions). as shown in table , rs who reported feeling threatened by sars were also more likely to report wishing sars would go away and to seek support from others to deal with their perceptions of threat. those higher on threat were also more likely to report engaging in avoidant behavior, such as avoiding public places and avoiding people perceived to be at a higher risk of having been exposed to the virus, such as healthcare professionals or people who looked ill. finally, they were more likely to report engaging in such preventative health behaviors as washing their hands and getting sufficient rest. the correlations between coping and health behaviors are presented in table . wishful thinking, support seeking and empathic coping were significantly and moderately intercorrelated ( r 's from . to . ). the intercorrelations among the abbreviated forms of the coping subscales used here are similar in size to those reported in previous studies using the full scales (folkman et al ., ) . as shown in table , rs who tended to wish that sars would go away as a way of dealing with the threat of sars, also tended to report avoiding both public places, such as markets or restaurants and individuals perceived to have a higher likelihood of being exposed to the sars virus. these rs also tended to report engaging in health precautions, such as using disinfectants and taking more care with cleanliness. rs who reported seeking social support in response to the threat of sars were also likely to report avoiding people perceived to be at high risk of sars, such as health-care workers, and engaging in health behaviors, such as eating a balanced diet and exercising regularly. however, these rs were only slightly more likely to report avoiding public places as a response to the sars threat ( r = , p < . ). rs high on empathic responding tended to report avoiding a variety of public places in an effort to avoid exposure to sars. furthermore, those high on empathic responding tended to report engaging in more protective health behaviors, such as hand washing, in their efforts to prevent spread of the disease. however, these bivariate relations are difficult to interpret given the potential confounding of coping and health behaviors with perceptions of the threat of sars and with state anxiety. multivariate analyses were conducted controlling for perception of threat and levels of anxiety, as well as scores on all coping scales, in order to allow a more meaningful picture of the independent associations of each form of coping to each of the three health behaviors examined here. table presents the results of three hierarchical linear regression analyses. these were used to examine the relationship between coping and perceived threat of sars to each of the three types of health behaviors examined in the study, avoiding public places, avoiding people and taking precautions. state anxiety was entered in step of the equation, perception of sars threat in step and the three coping strategies (wishful thinking, support seeking and empathic responding) as a set in step . both wishful thinking ( b = . ), t ( ) = . , p < . and perception of sars threat ( b = . ), t ( ) = . , p < . were significantly positively associated with avoidance of public places even after controlling for state anxiety, support seeking and empathic responding. that is, rs who reported engaging in more wishful thinking to cope with the threat of sars were more likely to report avoiding public places as a way to reduce exposure to the sars virus. sars threat ( b = . ), t ( ) = . , p < . and wishful thinking ( b = . ), t ( ) = . , p < . were significantly associated with a greater likelihood of avoiding people. this held even after controlling for state anxiety, support seeking and empathic responding. empathic responding was associated with significantly lower reports of trying to avoid other people (b = - . ), t( ) = - . , p < . , again controlling for state anxiety, perception of sars threat and the other coping strategies. in other words, rs who reported the use of wishful thinking as a way of coping with the threat of sars were more likely to report avoiding people perceived to be at risk for having sars. however, rs who reported the use of empathic responding were less likely to report engaging in such behavior, once threat of sars and anxiety were controlled. finally, sars threat (b = . ), t( ) = . , p < . and empathic responding (b = . ), t( ) = . , p < . were significantly associated with taking precautions, even after controlling for state anxiety and ways of coping with sars. that is, rs who reported responding to the threat of sars through empathic responding were more likely to report taking health precautions to decrease the risk of getting sars. in sum, multivariate analyses controlling for differences in perceived threat of sars, state anxiety and other ways of coping indicated that both wishful thinking and empathic responding were significantly associated with specific sars-related health behaviors. controlling for differences in perceived threat of sars, state anxiety and other ways of coping, support seeking was not significantly related to the sars-related health behaviors examined in the present study. the current study examined the psychological impact of sars by examining the coping strategies and health behaviors reported in response to the sars outbreak. consistent with the study by tam et al. (this issue) and that by chang and sivam (this issue) , the present findings revealed a link between cognitions and coping responses. our findings suggest that feeling threatened by sars is associated with the use of such coping strategies as wishful thinking and support seeking. it further suggests that patterns of coping with the threat of sars are associated with engaging in specific health-related behaviors intended to reduce the risk of infection. interestingly, this pattern of findings appeared to remain the same regardless of gender, education, and whether the individual was from a sarsaffected area. specifically, those participants who reported engaging in wishful thinking in response to the threat of sars appear more likely to engage in two forms of avoidant health behavior: avoiding public places and avoiding people perceived to be possible carriers of the sars virus. however, those engaging in wishful thinking regarding the virus did not describe themselves as engaging in more of the sort of health behaviors most likely to be viewed as effective by health-care professionals. that is, wishful thinking does not appear to facilitate engaging in critically important health behaviors, such as hand washing and using disinfectants to clean potentially contaminated surfaces. conversely, those who reported the use of empathic responding were not only less likely to report avoiding people who may be perceived as potentially having sars but also more likely to report engaging in precautionary measures and health behaviors likely to be viewed as effective (cdc, a (cdc, , b (cdc, , c who, a) . hence, those who report using empathic responding in response to sars appear to use effective precautionary health behaviors without engaging in avoidant health behaviors that were associated with significant economic and societal costs. consistent with our expectations, it may be that using empathy and perspective-taking to cope with threatening events inhibits a knee jerk reaction to simply avoid anyone who is perceived as being a possible threat. empathic responding may inhibit individuals from viewing the public at large and the places in which they can be found as a primary threat and therefore something to be avoided. as such, health behavior efforts may be geared more toward prevention than avoidance. the present study suggests that those who can respond empathically to others even in the presence of health threats may be better at engaging in productive health behaviors that may contribute to their own and to others' health and well-being. although perception of sars threat was associated with the use of support seeking, this coping strategy was not significantly associated with engaging in the sars-related health behaviors examined in this study, controlling for the other variables examined. there are several possible reasons for this. it may be that we did not have sufficient power to detect an effect given the relatively small sample size. support seeking may also be related to other outcomes not examined in the present study such as mood or feeling comforted, and it may be that any relation between support seeking and health behaviors is indirect via these more direct effects of social support. finally, as is observed in the general literature on social support, the effect of support seeking on outcomes may depend upon the response of others (lehman et al., ) . that is, others may not always respond favorably to requests for support. previous research has indicated that even when support is offered to another, it is not always perceived as helpful. for example, cancer patients report that a sizable proportion of the support that is offered to them fails to provide the comfort or aid that was presumably intended (dakof & taylor, ) . in the context of health behaviors, support may not always be sufficient to promote effective health behaviors. consequently, it may be that we need to examine the interactional patterns between the person eliciting support and the recipient of the support requests if we are to understand the ultimate effects of support seeking. an obvious limitation of the present study is the cross-sectional nature of the data that does not allow the examination of changes over time or processes. the understanding of how individuals cope with sars would be aided by longitudinal data permitting, for example, examination of the endurance of health behavior changes or how fluctuations in perceptions of threat, perhaps related to media reports, are related to changes in health behaviors. furthermore, the sample was collected through the internet using self-report data and thus is subject to the biases and limitations of self-report data and selective sampling due to the use of the internet. benefits of the internet as a collection tool include cost-effectiveness and the enhanced reach of sampling demographics. additionally, there are recommended strategies to avoid such problems as data falsification and data security issues (smith & leigh, ) . however, care must be taken to be aware of the medium's limitations as well. the question of validity is an important one. studies comparing data collected in traditional formats, such as pencil-and-paper (schwarzer et al., ) and telephone survey (chang, ) have found that internet studies have high validity and yield similar results to data collected in more traditional mediums. in fact in some cases (chang, ; murray & fisher, ) , internet surveys have shown higher predictive validity and better psychometric properties than more traditional mediums. however, it is important to note that, as with many mediums, data collected from the internet cannot be assumed to be representative of the general population. according to the american internet user survey, differences include internet users generally being younger, wealthier and more educated than average survey participants (national science foundation, ) . another notable limitation of the present study is that it examined only a few possible coping strategies using brief measures. there may be other coping strategies important to understanding the psychological and behavioral responses to the threat of sars, such as problem-focused coping. additionally, despite examining the role of education, gender and geographic region and failing to find significant differences, our sample is reflective of a well-educated, young, female population mostly residing in canada, which is unlikely to be representative of populations in other countries. given the international nature of sars and its impact, future research should examine a broader sample to see the extent to which the results identified in the present study generalize to other populations. understanding cultural and geographic differences in coping strategies and health behaviors may facilitate designing more effective health promotion campaigns and media messages focusing on those messages with wider applicability across divergent groups. finally, the present study did not examine the impact of coping on close others. for example, network members may both facilitate and hinder health behaviors as well as impact and be impacted by the coping of another. the current study examined the individual in isolation, which does not capture the interpersonal nature of coping in general or of the sars threat in particular. while sars may be transmitted via body fluids person to person, the threat and fear associated with the disease surrounding it travel even faster from person to person. this threat may ultimately be just as damaging to society and individual well-being as the disease itself is to the health of those infected. given the significant relationships that emerged between coping and health behaviors, the present study highlights the importance of considering coping in managing health threats and in encouraging and discouraging various health behaviors (see also chang & sivam, this issue; gan et al., this issue) . the avoidant behaviors reported in the present study (avoiding public places and people perceived to be at a higher risk for having sars) and the study by gan et al. (this issue ) may be associated with significant economic and societal costs to areas affected by sars. for example, the ontario government reported that sars-related costs, including lost revenue related to decreased tourism and commerce, and assistance for individuals, the health-care system and economic recovery totalled $ . billion can © blackwell publishing ltd with the asian association of social psychology and the japanese group dynamics association (ontario government, b) . in communities across canada, community leaders called for awareness programs to address what they saw as a growing aversion towards the asian community (e.g. ontario government, a; rider, ) . understanding that wishful thinking in response to the threat of sars is related to such avoidant behaviors offers the possibility of minimizing the use of this coping strategy and the resultant economic and societal impact this form of coping has had on sars-affected cities around the globe. similarly, the results reported here in relation to avoiding people have significant implications for managing public perceptions of disease threats, particularly when individuals being avoided may belong to a particular ethnic group or groups of health-care professionals. the latter may inadvertently serve to reduce the probability of preventative treatment. having this knowledge can assist public health officials in promoting positive health behaviors while at the same time assisting them in promoting accurate knowledge that will not result in the targeting of particular individuals. notably, our findings suggest methods of coping, such as empathic responding, which might usefully be encouraged via mass media campaigns to both increase effective preventative health behaviors and decrease behaviors that are likely ineffective at best, and potentially damaging to society at worst. it may be important to encourage the use of empathy in coping with health-threatening diseases such as sars in our public health messages given that such coping strategies are not associated with higher feelings of threat and are associated with better health behaviors. given the global impact of sars on health, perceptions of threat, economic functioning, and societal stability, understanding the psychological impact of sars is critical in our attempts to manage the disease and the public reaction to it. knowledge of the psychological reaction to sars may help us create more effective and productive health messages aimed at limiting the detrimental effects such diseases can have on the well-being of society, even among those many who never contract the disease. linda d. cameron (university of auckland), lois c. friedman, mary poon (san francisco general hospital), nicholas difonzo (rochester institute of technology), noelle leonard, prashant bordia (university of queensland), rima styra (university health network), stefano occhipinti (griffith university) and winnie w.s. mak (chinese university of hong kong). . due to the collaborative nature of the questionnaire, there were limitations on the number of items that could be included. given the space restrictions, only one wishful thinking item was included. . while state anxiety may also be viewed as a dependent variable, the current study sought to examine health behaviors as the outcome variable. given this goal, state anxiety was controlled for in the analyses to ensure that the relationships observed between coping and health behaviors were not simply due to their shared variance with general state anxiety. further, in examining the relationship of threat of sars to health behaviors, we wanted to control for the respondent's general level of anxiety, so that we could examine the specific effects of sars-related fears on health behaviors. . we also ran a series of hierarchical linear regression analyses controlling for the effects of education, gender, affected versus non-affected sars region, and the interactions between coping and gender, coping and affected/non-affected areas, and coping and time of responding (e.g. before or after mid-july). the pattern of findings regarding the relationship of coping to health behaviors in these analyses was identical to those reported here. . a regression model was also run with the two items tapping social support (instrumental and emotional) entered separately. the effects of social support on health behaviors remained nonsignificant in these models, regardless of whether the two items were entered together in the same equation or in separate equations. anne marie vartti (finnish national public health institute), arja r aro (erasmus medical center living in the midst of a killer virus providing social support may be more beneficial than receiving it: results from a prospective study of morality hand hygiene in healthcare settings interim guidance on infection control precautions for patients with suspected severe acute respiratory syndrome (sars) and close contacts in households 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life changes following bereavement and their relations to adjustment the internet: a virtually untapped tool for research the application and implications of information technologies in the home: where are the data and what do they say? available at coping with chronic stress: an interpersonal perspective commission urges tolerance and respect during the sars health emergency. news release the association of coping to physical and psychological health outcomes: a meta-analytic review fear of virus fuels racism: ontario must do more to stop return to days of 'yellow peril', asian leaders say assessment of perceived general self-efficacy on the internet: data collection in cyberspace virtual subjects: using the internet as an alternative source of subjects and research environment manual for the state-trait anxiety inventory -form x biases in the perceived prevalence and motives of severe acute respiratory syndrome prevention behaviors among chinese high school students in hong kong psychological stress in nurses' relationships with hiv infected patients: the risk of burnout syndrome frequently asked questions on severe acute respiratory syndrome (sars) this research was supported by a sshrcc grant to the second author and a sshrcc and michael smith doctoral fellowship to the first author. we would like to thank our colleagues in the sars collaborative research group, particularly george bishop, for input regarding the design of this study. key: cord- -opf qwgl authors: hiremath, channabasavaraj shivalingaiah; yadava, om prakash; meharwal, zile singh; iyer, krishna subramony; velayudhan, bashi title: iacts guidelines: practice of cardiovascular and thoracic surgery in the covid- era date: - - journal: indian j thorac cardiovasc surg doi: . /s - - -w sha: doc_id: cord_uid: opf qwgl patients undergoing cardiovascular and thoracic procedures are at an accentuated risk of higher morbidity and mortality, which are a consequence of the proliferative nature of the severe acute respiratory syndrome-corona virus (sars-cov- ) on the lung vasculature, which in turn reflects as a cascading effect on the interdependent physiology of the cardiovascular and pulmonary organ systems. these are secondary to systemic inflammatory response syndrome and immunosuppressive responses to surgery and mechanical ventilation. thus, the need to establish guidelines for the practice of cardiothoracic surgery which is safe for both the patient and the healthcare team presents as a priority, which is the mainstay of this article. the corona virus disease- (covid- ) pandemic has caused a profound global impact. the medical infrastructure across the world continues to be the first response in tackling the challenges. needless to say, the medical workforce has been pressed into action, beyond capabilities to cater to the affected, making it the largest workforce the world over, working beyond its functional capacity. albeit there have been significant restrictions on routine medical practice and cardiothoracic disease, coronavirus by virtue of its behaviour presents without attenuation of intensity and time. with most testing and diagnostics at an all-time high of deferrals, patients with underlying cardiovascular lesions are at an unprecedented risk of adverse complications. deferring care to such patients can aggravate risk and potentially turn fatal. noting the pressure and presentation across subspecialties of medicine, cardiovascular care, if optimized and prioritized based on diagnosis, can help ease the caseload on the infrastructure with appropriate referral and recall. covid- trends have been inconsistent and unpredictable. thus, all stakes boil down to how well our practice can be optimized to unload the burden on our health infrastructure. a number of guidelines have been laid out in the public forum, by counterpart organizations to resume the practice of cardiovascular interventions through the peak of the pandemic. this advisory shall systematize resumption and caution in cardiothoracic surgical practice, as india continues to battle the pandemic at its peak. the indian association of cardiovascular-thoracic surgeons supports this document. as per ministry of health and family welfare, the covid- case definitions are as follows [ ] . a. a patient with acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g. cough, shortness of breath) and a history of travel to or residence in a location reporting community transmission of covid- disease during the days prior to symptom onset or b. a patient with any acute respiratory illness and having been in contact with a confirmed or probable covid- case in the last days prior to symptom onset or c. a patient with severe acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g. cough and shortness of breath, and requiring hospitalization) and in the absence of an alternative diagnosis that fully explains the clinical presentation a. a suspect case for whom testing for the covid- virus is inconclusive or b. a suspect case for whom testing could not be performed for any reason a person with laboratory confirmation of covid- infection, irrespective of clinical signs and symptoms. suspected and probable cases are put together for ease of management as shown in fig. . a -day quarantine mandate for all patients is ideal for optimal detection of covid- symptoms [ ] . however, surgical emergencies may be taken up with universal precautions and level iii personal protective equipment (ppe). in all such cases, a baseline nasopharyngeal swab for reverse transcription polymerase chain reaction (rt pcr) should be sent. all patients who are symptomatic, rt pcr positive or with positive findings on high-resolution computed tomography (hrct) should be referred for covid- treatment. figure outlines the management of a suspected covid- case. an asymptomatic patient with negative rt pcr and hrct can become positive during the course of hospital stay in view of longer incubation periods. hence, repeat of rt pcr tests every days for a period of weeks during the course of hospital stay is recommended. [ ] . however, repeat rt pcr testing can be avoided in patients with a positive baseline rapid antibody test [ ] . hrct is currently not recommended by the centers for disease control and prevention (cdc, usa) or by the american college of radiology guidelines to establish diagnosis of covid- . nevertheless, in situations of equivocality or when there is no facility for rt-pcr testing, the team may use their discretion to perform a hrct chest as an adjunct investigation to add to the positive predictive value of preoperative workup [ , ] . as an exemption to this rule, given the lack of evidence as well as requirements of sedation and radiation exposure, hrct chest may be used sparingly and with caution in children undergoing surgery [ ] . newborns needing cardiac surgery should be isolated from covid- -positive mothers in order to avoid post-natal infection. it is recommended that they be tested at , and days of life [ ] . vertical transmissions are not known to occur, so if the baby has been separated from the mother at birth, then testing may not be necessary [ , ] . the accompanying person/parents entering the hospital or outpatient department (opd) should also be screened for history and symptoms of covid- . microbiological testing of the attenders/parents should be done when the patient is planned for admission. respiratory specimen collection methods [ ] lower respiratory tract • bronchoalveolar lavage, tracheal aspirate and sputum • collect - ml into a sterile, leakproof, screw-cap sputum collection cup or sterile dry container. & oropharyngeal swab (e.g. throat swab): tilt patient's head back °. rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth and gums. use only synthetic fibre swabs with plastic shafts. do not use calcium alginate swabs or swabs with wooden tilt patient's head back °. while gently rotating the swab, insert swab less than one inch into nostril (until resistance is met at turbinates). rotate the swab several times against nasal wall and repeat in other nostril using the same swab. place tip of the swab into sterile viral transport media tube and cut off the applicator stick. for throat swab, take a second dry polyester swab, insert into mouth and swab the posterior pharynx and tonsillar areas (avoid the tongue). place tip of swab into the same tube and cut off the applicator tip. tilt patient's head back °. insert flexible swab through the nares parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient. gently, rub and roll the swab. leave the swab in place for several seconds to absorb secretions before removing. clinicians may also collect lower respiratory tract samples when these are readily available (for example, in mechanically ventilated patients). in hospitalized patients in dedicated covid- hospitals (severe cases with confirmed covid- infection), repeat upper respiratory tract samples should be collected to demonstrate viral clearance. in the setting of substantially limited resources, proper prioritization of patients requiring surgery is of paramount importance. hence, it is important to triage patients into elective and emergency patients (fig. ). all adult cardiac, congenital cardiac [ ] , thoracic [ ] and vascular cases [ , ] may be categorized into 'emergent cases' requiring intervention within to h, 'urgent cases' requiring surgery within weeks and 'high-priority' cases which have to be prioritized over the rest of the cases. all elective/deferred patients should be periodically re-evaluated and re-triaged based on signs and symptoms (table ) . (table ) orthotropic heart transplantation is excluded from table . the decision to accept a donor heart during this pandemic depends on the clinical status of the recipient, the estimated risk of the donor's potential exposure to covid- in their community and hospital, and the prevalence of covid- in the hospital and community of the recipient in light of the immunosuppression the recipient will receive. thoracic surgery (table ) vascular surgery (table ) it is the responsibility of the lead surgeon to explain the risks associated with surgery and postoperative care during these extraordinary circumstances. in addition to regular surgical consent, the following points need to be impressed on the patient/attenders as part of informed consent. not much is known about the pathophysiology and course of covid- , and most treatments available are experimental. there is a proven increased risk in morbidity and mortality in covid- patients undergoing cardiac surgery [ ] . a sample consent form can be downloaded from www. iacts.org. the ppes are to be used based on the risk profile of the health care worker. table describes the level of ppe to be used in different settings [ ] . intra-operative guidelines [ ] [ ] [ ] [ ] operating room management operating rooms should be sanitized after each case or dedicated operating rooms if feasible should be set up for all confirmed or suspected covid- patients. "covid- precautions" signs to be posted on all doors to the operating rooms (or) suite to inform staff of the potential risks and minimize exposure. majority of operation rooms in india are not negatively pressurized; the positive-pressure system and central air conditioning must be turned off. to convert an existing or into a covid- or, it is first necessary to convert the or into a non-recirculatory system ( % oncethrough system) the exhaust air quantity shall be greater than the supply air quantity such that a negative pressure of minimum . pa (preferably > pa) is achieved in the room. the supply air quantity shall be such that it will provide a minimum of air changes per hour. the position of the exhaust in the or should ideally be above the head of the patient [ ] . maintain relative humidity between and % [ ] . there should be dedicated rooms for donning and doffing of ppe with separate entry and exit points. the donning area should have adequate number of presterilized ppe kits and hand scrubbing facility. all or staff to be kept at the minimum with minimum movement in and out of the or complex. or doors should always be kept close. the staffs are required to practise enhanced droplet and contact precautions in the or at all times with ffp- masks, disposable fluid-proof gown, gloves, cap, face shield or goggles and shoe covers. the ministry of health and family welfare (mohfw) recommends the use of various levels of ppe as per risk as given in table . a team meeting albeit with physical distancing should take place before surgery to ensure everyone understands the plan for anaesthesia, perfusion and surgery. this enables seamless teamwork and ensures that all necessary drugs and equipment have been prepared. it also minimizes the need to leave and re-enter the or to bring in missing equipment. extubation requires similar precautions. antitussives and antihistaminics to be considered as premedication. [ ] . induction of anaesthesia and securing of the airway should be performed by the most skilled operator using adjuncts like video-laryngoscopy. in case the patient has increased secretions, layers of wet gauze can be used to cover the patient's nose and mouth. endotracheal tube (ett) cuff to be inflated immediately after intubation to prevent aerosolization. intubating personnel should be double gloved and be distant from the airway. minimize the period of mask ventilation as far as possible as this is considered an agp. induction can be performed using waters or circle systems, with heat and moisture exchange filters (hmef) as close to the patient as possible. once circuit has been secured, vigilance should be exercised as disconnection will cause aerosolization. anti-emetics should be administered to reduce postoperative retching. a rigid suction catheter may be used to reduce the chance of contaminating the surroundings with the soft flexible suction catheter. all lines should be inserted after intubation. staff to be kept at a minimum until intubation is done. equipment around the patient's head should be immediately cleaned with disinfectant to reduce the risk of fomite spread. trans-oesophageal echocardiography (tee) in an intubated patient has not demonstrated aerosol production. after removal, it should be decontaminated using . % alkaline glutaraldehyde solution for min or as per local institutional protocols of tee disinfection. the hightouch surfaces of the machine and probe should be covered by disposable plastic sheets [ ] . technician or helping staff should maintain -m distance or as much as possible at the time of induction. routine antibiotic prophylaxis is to be followed. there is no evidence or recommendation for the use of hydroxychloroquine or azithromycin prior to surgery. however, as per ministry of health and family welfare, all hospital personnel handling covid- cases are advised hydroxychloroquine prophylaxis. the surgical and perfusion teams to enter or min after intubation if haemodynamic status of the patient permits. however, they should be available in close vicinity of the patient for any emergency. this may be avoided if the patient has tested covid- negative. a smoke evacuator may be used when electrocautery is being used [ ] . the mister blower should be used with caution. use of video-assisted thoracoscopic surgery (vats) and minimally invasive cardiac surgery (mics) should be decided on case-to-case basis due to risk of aerosolization from co insufflation systems with inadvertent lung injury. use of a non-sealed endoscopic vessel harvesting (evh) approach during coronary surgery using an endoscopic retractor (bisleri model, karl storz, tuttlingen, germany) to spread the tissue instead of co insufflation [ ] . there are no contraindications for the use of blood and blood products as sars-cov- is not known to produce viraemia. emphasis should be laid on meticulous haemostasis. it is better to wait in or for a while before chest closure than to wheel the patient back to or for re-exploration. extubation/transfer of patient as most cardiac patients being operated on during the pandemic are of a sicker subset, patients should be transferred directly to the designated intensive care unit (icu) for delayed extubation. the total period of mechanical ventilation should be reduced as far as possible with early weaning and extubation. helping staff/technician should assist extubation from head end, instead of coming in line of patient's aerosol direction [ ] . ett cuff to be deflated at the very last, just before removal of ett. post extubation, protective masks to be applied at the earliest on the patient. supplementary oxygen mask can be put over the protective face mask if needed. all the soiled and disposable items should be discarded as per protocol for biomedical waste disposal. staff to doff the gowns into appropriate biohazard bags, keeping ffp mask and hoods on. while leaving the or complex, ffp masks and hoods can be removed. if facilities exist, all staff are advised to shower, preferably before leaving the or complex. the or ventilation system is to be kept at positive pressure during decontamination. after the patient has been wheeled out, the theatre is left empty for at least min before cleaning is commenced. positive-pressure airflow is maintained for more minutes to allow air exchange [ ]. after surgery for emergency cases/unknown covid- status, the anaesthetic breathing circuit and canister of soda lime should be discarded to eliminate the negligible risk of circuit contamination [ ] . all airway equipment should be sealed in double ziplock plastic bags before being sent for decontamination and disinfection [ ] . unused items on the drug tray are assumed to be contaminated and hence discarded. metallic equipment to be kept in % sodium hypochlorite solution for at least min. routine cleaning of all surfaces and ot equipment using a chlorine or chlorine dioxide-based disinfectant should be done. high-touch areas such as that of the anaesthetic and echocardiography machines may be wrapped with plastic sheets to facilitate decontamination [ ] . the cardiopulmonary machines have varying surfaces which must be cleaned with the appropriate agents. the corridor areas outside of the theatre within m should also be cleaned. fumigation of or with sodium hypochlorite ppm and ammonium chloride-based solution or % alcohol wiping of surfaces should suffice. additional protocols with hydrogen peroxide vaporization or ultraviolet (uv)-c irradiation may be deployed if available [ , ] . there is no requirement of a quarantine zone around or [ ]. modifications to be adopted to routine cardiac critical care management during the covid- era [ , ] . & personnel performing endotracheal suctioning should wear level ii ppe [ ] . & intercostal drain care in case of an air leak, there is aerosolization via chest drain circuit. in a patient without covid- symptoms and negative rt pcr, routine intercostal drain (icd) care is to be followed [ ] . in a suspect patient, a subsequent covid- positive patient, the following measures could be taken. -it can be directly connected to the wall suction to minimize exposure. -a viral filter can be attached at the suction port [ ] . -a cut ett attached to a hmef filter can be fixed to the suction port [ ] . & tracheostomy care level ii ppe for personnel performing suctioning and tube change. level iii ppe in covid- -positive cases. closed suction system is to be used and usage be guarded. a double lumen-cuffed tube may be used to avoid frequent tube change due to tube blockage postoperatively. hmef is to be attached to tracheostomy tube when patient is shifted to icu. a suspected covid- patient with a tracheostomy, who has been weaned off mechanical ventilation and oxygen, the tracheostomy tube may be further covered with a ffp- mask to prevent aerosolization [ ] . & anticoagulation and antiplatelet therapy recommendation [ ]. a patients who are on anticoagulation or antiplatelet therapy for other underlying conditions should continue these medications even if they are diagnosed covid- positive. b anticoagulation and antiplatelet therapy to be followed as per routine protocol in hospitalized patients irrespective of covid- all patients and their accompanying persons entering the hospital should be masked at the triage area. a screening and temperature check is to be performed on all patients before sending to designated opds. in the waiting area, a distance of m is to be maintained between the patients. all the health personnel in the opd not indulging in agps should protect themselves with n masks and gloves. this document is an advisory-based position statement based on current practice, literature, resources and expert opinion as on date. it is pertinent to state that new evidence is continuously emerging and guidelines are being issued regularly. this is formulated with a hope to guide surgeons to resume cardiac surgery keeping in view the safety of the patient and hospital personnel. all guidelines for routine surgical practice still hold true, and the above document should not be read in exclusion. these guidelines are not binding and the user may modify them based on local circumstances. it is reemphasized and worth noting that regular handwashing, utility of face masks and maintaining social distancing will help keep the virus as far away as possible and help win this arduous battle of these times. ment and treatment of covid- and asymptomatic healthcare workers working in non-covid hospitals/ non-covid areas of covid hospitals/blocks asymptomatic frontline workers, such as surveillance workers deployed in containment zones and paramilitary/ police personnel involved in covid- -related activities. asymptomatic household contacts of laboratory confirmed cases. the drug is contraindicated in persons with known case of: retinopathy hypersensitivity to hydroxychloroquine (hcq) or aminoquinoline compounds glucose phosphate dehydrogenase (g pd) deficiency. pre-existing cardiomyopathy and cardiac rhythm disorders. the drug is not recommended for prophylaxis in children under years of age, pregnancy and lactation. rarely, the drug causes cardiovascular side effects such as cardiomyopathy and rhythm (heart rate) disorders. in that situation, the drug should be discontinued. it can rarely cause visual disturbance including blurring of vision which is usually self-limiting and improves on discontinuation of the drug. for the above-cited reasons, the drug has to be given under strict medical supervision with an informed consent. kindly refer to the indian council for medical research (icmr) guidelines for further information. directorate general of health services, ministry of health and family welfare, government of india. clinical management protocol covid- (version the incubation period of coronavirus disease (covid- ) from publicly reported confirmed cases: estimation and application testing recommendation for covid- (sars-cov- ) in patients planned for surgery -continuing the service and 'suppressing' the pandemic american college of radiology recommendations for the use of chest radiography and computed tomography (ct) for suspected covid- infection correlation of chest ct and rt-pcr testing in coronavirus disease (covid- ) in china: a report of cases covid- faq's in pediatric cardiac surgery an analysis of pregnant women with covid- , their newborn infants, and maternal-fetal transmission of sars-cov- : maternal coronavirus infections and pregnancy outcomes vertical transmission of coronavirus disease (covid- ) from infected pregnant mothers to neonates: a review covid- : crisis management in congenital heart surgery covid- : elective case triage guidelines for surgical care (thoracic surgery vascular surgery in the covid- pandemic covid- : elective cases triage guidelines for surgical care (vascular surgery mortality and pulmonary complications in patients undergoing surgery with perioperative sars-cov- infection: an international cohort study. the lancet directorate general of health services, ministry of health and family welfare, government of india. novel coronavirus disease (covid- ): guidelines on rational use of personal protective equipment category of personnel and treatment of covid- and asymptomatic healthcare workers working in non-covid hospitals/non-covid areas of covid preparing for a covid- pandemic: a review of operating room outbreak response measures in a large tertiary hospital in singapore cardiac surgery and the covid- outbreak: what does it mean? available from guidance document to uk cardiac and thoracic teams for procedures on patients with covid- adult cardiac surgery and the covid- pandemic: aggressive infection mitigation strategies are necessary in the operating room and surgical recovery covid operation theatre-advisory and position statement of indian society of anaesthesiologists (isa national) specific considerations for the protection of patients and echocardiography service providers when performing perioperative or periprocedural transesophageal echocardiography during the novel coronavirus outbreak: council on perioperative echocardiography supplement to the statement of the american society of echocardiography: endorsed by the society of cardiovascular anesthesiologists covid- : considerations for optimum surgeon protection before, during, and after operation improved safety of endoscopic vessel harvesting during the covid- pandemic intensive care management of coronavirus disease (covid- ): challenges and recommendations ministry of health & family welfare, government. guidelines for safe ent practise in covid pleural services during the covid- pandemic coronavirus disease- : modified underwater seal chest drain system covid- rapid evidence summary: angiotensin-converting enzyme inhibitors (aceis) or angiotensin receptor blockers (arbs) in people with or at risk of covid. available from: www.nice.org.uk/guidance/ es ministry of health & family welfare, government of india. revised advisory on the use of hydroxychloroquine as prophylaxis for sars-cov- infection publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -xl fv qx authors: kahn, r. e.; morozov, i.; feldmann, h.; richt, j. a. title: th international conference on emerging zoonoses date: - - journal: zoonoses public health doi: . /j. - . . .x sha: doc_id: cord_uid: xl fv qx the th international conference on emerging zoonoses, held at cancun, mexico, – february , offered participants from countries, a snapshot of current research in numerous zoonoses caused by viruses, bacteria or prions. co‐chaired by professors heinz feldmann and jürgen richt, the conference explored topics: (i) the ecology of emerging zoonotic diseases; (ii) the role of wildlife in emerging zoonoses; (iii) cross‐species transmission of zoonotic pathogens; (iv) emerging and neglected influenza viruses; (v) haemorrhagic fever viruses; (vi) emerging bacterial diseases; (vii) outbreak responses to zoonotic diseases; (viii) food‐borne zoonotic diseases; (ix) prion diseases; and (x) modelling and prediction of emergence of zoonoses. human medicine, veterinary medicine and environmental challenges are viewed as a unity, which must be considered under the umbrella of ‘one health’. several presentations attempted to integrate the insights gained from field data with mathematical models in the search for effective control measures of specific zoonoses. the overriding objective of the research presentations was to create, improve and use the tools essential to address the risk of contagions in a globalized society. in seeking to fulfil this objective, a three‐step approach has often been applied: (i) use cultured cells, model and natural animal hosts and human clinical models to study infection; (ii) combine traditional histopathological and biochemical approaches with functional genomics, proteomics and computational biology; and (iii) obtain signatures of virulence and insights into mechanisms of host defense response, immune evasion and pathogenesis. this meeting review summarizes of the conference presentations and mentions briefly the articles in this special supplement, most of which were presented at the conference in earlier versions. the full affiliations of all presenters and many colleagues have been included to facilitate further inquiries from readers. addition to the summaries later of six presentations on this topic, this special supplement includes an article, monitoring of west nile virus infections in germany by dr. u. ziegler et al. which identified west nile virus (wnv) antibodies in migratory birds, but not in resident birds, in domestic poultry or in local horse populations throughout germany. the wnv antibody-positive species were found in birds that migrate to tropical africa or southern europe; however, wnv-specific rna could not be found in any of the samples. the conference opened with a presentation from professor m. a. diuk-wasser and her colleagues j. simpson and c. m. fosom-o'keefe (all yale school of public health, new haven, ct, usa) and g. molei, p. m. armstrong, and t. g. andreadis (center for vector biology and zoonotic species at the connecticut agricultural experiment station, new haven, ct, usa), ecology of west nile virus in the north-eastern united states. professor diuk-wasser began by noting that west nile virus (wnv) was introduced into new york city in by unknown means and was now considered endemic throughout the usa, with , human cases and , deaths in the usa since . it had been hypothesized that increased biodiversity leads to a decreased risk of exposure to zoonotic pathogens (keesing et al., ) . at issue is whether this 'dilution effect' or 'zooprophylaxis' for vector-borne pathogens applies only when vectors are generalist feeders, because the link between host diversity and pathogen transmission might break down when vectors exhibit host preferences. in the north-eastern united states, wnv perpetuates in an enzootic transmission cycle involving culex spp. mosquitoes and virus-competent avian hosts. previous studies had detected that a large proportion of c. pipiens and c. restuans bloodmeals were derived from american robins (turdus migratorius), suggesting a key role for this bird species in the wnv transmission cycle (kilpatrick et al., ; molaei et al., ) . the new haven-based research team tested for preferential feeding by conducting equal choice experiments (robins versus other bird species) (simpson et al., ) and by comparing the proportion of culex spp. bloodmeals acquired from robins to the proportion of robins in the local bird community. both methods indicated preferential feeding for robins. they were also able to identify robin communal roosts as amplification foci in greater new haven (diuk-wasser et al., ) . then, through field-informed mathematical modelling, they determined that host preferences were indeed key drivers of wnv transmission and that landscape attributes (such as urbanization) in combination with mosquito abundance and a measure of host community competence were the strongest predictors of pathogen prevalence (simpson et al., ) . thus, it was clear that pathogen prevalence and human risk of infection were best predicted by assessing the relative pathogen competence and attractiveness to vectors of all species in the host community, rather than using simple measures of biodiversity. in the next presentation, interactions among multiple tick-borne pathogens in a natural reservoir host, professor fish and his colleagues j. brown, m. fitzpatrick, s. usmani-brown, p. cislo and p. krause (yale school of public health, new haven, ct, usa) stressed that species interactions within a parasite community drive infection risk in a wildlife population (telfer et al., ) . at least five tick-borne pathogens are known to be transmitted by ixodes scapularis, the principal vector of lyme disease in the united states: (i) borrelia burgdorferi, an agent of lyme disease; (ii) anaplasma phagocytophilum, an agent of human anaplasmosis; (iii) babesia microti, an agent of human babesiosis; (iv) borrelia miyamotoi, an agent of relapsing fever; and (v) the powassan encephalitis virus. two or more of these pathogens can be transmitted either simultaneously by a single tick or sequentially by successive tick-bites, resulting in different permutations of mixed-infection studies. in the context of pathogen prevalence of ixodes scapularis nymphs, borrelia burgdorferi, has been found in . % of samples from the north-east and mid-western united states, while babesia miroti has been found in . % of samples from block island, rhode island. professor fish explained that several types of co-infections have been explored in an experimental system employing laboratory colonies of i. scapularis ticks and peromyscus leucopus white-footed mice, a natural reservoir host for these pathogens. outcomes of mixed infections in mice have been measured by r o , the fitness parameter and basic reproductive rate which indicates the number of secondary tick infections resulting from a primary infection (levin and fish, ) . the observed outcomes of dual mixed infections have been variable with both positive and negative effects on r o , while interactions have been mutual, unidirectional or null. these diverse pathogen interactions play an important role in determining the infection prevalence of host-seeking nymphs in nature, and consequently, in the risk of infection for humans. professor h. henttonen (finnish forest research institute, vantaa, finland) and his team h. leirs, e. r. kallio, k. tersago and l. voutilainen in collaboration with university of antwerp, belgium; university of liverpool, united kingdom; and the universities of helsinki and jyväskylä, finland, studied biome specific rodent dynamics and hanta epidemiologies in europe. their research sought to understand the main biomes and forest coverage in europe, the european hanta viruses and their carriers, and the biome specific dynamics of hanta virus carriers and the biome specific transmission dynamics and epidemiologies. within the bunyaviridae family of viruses, hantaviruses infect rodents (and insectivores) and cause haemorrhagic fever with renal syndrome (hfrs) in humans in the old world and hantavirus cardiopulmonary syndrome (hcps) in the new world. in a large european union project, eden (emerging diseases in a changing european environment, ), rodent-borne (robo) viral infections have been studied, along with tick-borne pathogens, leishmaniasis, west nile virus, malaria and rift valley fever. the most important aim of professor henttonen and his colleagues was to clarify the differences in boreal (northern) and temperate europe in the human epidemiology of nephropathia epidemica, by far the most common hantaviral disease in europe, caused by puumala hantavirus (puuv). the population dynamics of the host species, the bank vole, differ greatly in various parts of europe, driven by predation in the north and masting events in the temperate zone. consequently, the causes of rodent fluctuations are different. in addition, the role of landscape patterns (homogenous taiga vs. fragmented temperate forests) in rodent/virus dispersal is significant, as well as local environmental conditions (e.g. temperature and moisture), which affect virus survival outside the host. for example, in room temperature, puuv remains infectious for at least weeks outside the host, and possibly for much longer in cold temperatures and in moist conditions. these research findings are essential for human risk evaluation with regard to both long-term and seasonal occurrence of puuv in the environment. in spite of chronic infection of bank voles and the excretion of puuv in their faeces, urine and saliva, the shedding period is limited, which has significant implications for seasonal transmission dynamics in rodents. thus, within the same host/virus system, biomespecific puuv epidemiologies occur (kallio et al., ; tersago et al., ) , thereby highlighting the need for geographically comparative studies in europe (metla, ) . professor v. sambri and his team, p. gaibani, f. cavrini, a. m. pierro, m. p. landini and g. rossini (all regional centre for microbiological emergencies [crrem] , unit of clinical microbiology, st orsola-malpighi university hospital, bologna, italy) investigated usutu: a novel human pathogenic mosquito-borne flavivirus. this virus belongs to the japanese encephalitis serogroup within the mosquito-borne cluster of the genus flavivirus in the family flaviviridae. first isolated from mosquitoes of the genus culex in south africa in , the usutu virus (usuv) has since been isolated from mosquitoes, rodents and birds throughout sub-saharan africa and europe. the virus is thought to be maintained in nature in a mosquito-bird transmission cycle in areas with a minimum of at least ten hot days > °c, but no mammalian reservoir has yet been identified. professor sambri pointed out that it was not until september that usuv was found in the liver of a patient who underwent an orthotropic liver transplant (gaibani et al., ) . further study of the plasma and genome sequencing analysis confirmed the presence of usuv viremia. then usuv was detected in the livers of an additional four patients from the same area suffering from acute meningo-encephalitis during / . both serological assay and molecular assay have been used as new tools for the diagnosis of usuv infection. thus, it is now clear that usuv is a new emerging flavivirus pathogenic for humans. further studies are required to discover both the geographical distribution of this virus and the mechanisms by which humans acquire the virus. since this conference presentation, there has been increased awareness of the seriousness of usuv (vázquez et al., ) . according to the world health organisation (who) and unicef, . million children under the age of five die from diarrhoea annually (unicef/who, astroviruses cause infections within the small intestine and are associated with at least % of all sporadic cases and > % of all hospitalized cases. these rapidly evolving, nonenveloped, single-stranded rna viruses can be transmitted directly from infected individuals and animals, and indirectly through contaminated food and water. professor schultz-cherry's laboratory was the first to demonstrate that astroviruses induce diarrhoea by a novel mechanism: they possess an enterotoxin that disrupts intestinal epithelial barrier function independent of cellular damage or an inflammatory response (koci et al., ) . this occurs within h post-infection because of reorganization of the tight junction protein occludin and the actin cytoskeleton (moser et al., ) . in essence, within a complex pathogenic process, astroviruses cause diarrhoea by increasing intestinal barrier permeability. this is the first evidence showing that a viral coat protein is an enterotoxin. of great interest, the toxin can act independently of species barriers. given the increasing isolation of astroviruses from diverse species, there is increasing evidence that toxicogenic astroviruses could be associated with zoonotic disease. professor m. g. katze (department of microbiology and washington national primate research center, university of washington, seattle, wa, usa) set out a unifying approach to molecular biology in his presentation, systems and computational biology: emerging tools for exploring emerging viruses. he emphasized that modern day virologists and immunologists must do better in their search to understand how a virus kills and how effective vaccines can be developed, especially because traditional virology has yielded surprisingly little information about why some virus strains cause severe diseases while others remain innocuous. he pointed out that the case fatality rate for the influenza pandemic was about . % and that particular h n virus may have infected as much as one-third of the world's population. issues arise not only in understanding a virus, but also in understanding how hosts respond. for example, the virus infection resulted in very high expression of inflammatory, antiviral and immune cell genes very early in host infection (kash et al., ) . significant progress in overcoming existing and emerging viruses depends on biologists, mathematicians and computer specialists working together within a systems biology paradigm. such research begins with either in vitro studies of virus replication on cell lines or primary cell cultures, moving to nonhuman primate models of virus infection. then samples from the experiments are investigated at multiple time points and conditions; and high throughput data are then examined by data processing to prepare systematic evaluations of different host responses. data integration involving data analysis and modelling of key genes and pathways is then possible, followed by iterative processing of host perturbations and the use of viral mutants to discover specific applications to translational research. such a systems biology approach requires not only continuing experiments with virusinfected experimental systems but also significant efforts to maintain the hardware and software of an extensive laboratory computational infrastructure. it is this computing infrastructure, which permits the laboratory to go quickly from samples to pathway visualization, as the data analysis workflow moves from microarray images to gene expression data to pathway models. the mission of this virolab is to develop steadily over the years to come a virtual laboratory to confront the viruses involved in infectious diseases -influenza, ebola, marburg, hepatitis c, sars-cov, vaccinia, herpes simplex, west nile, hiv- , siv, measles, lassa, chikungunya and dengue fever. the three key characteristics of this integrated approach to so many infectious diseases are as follows: (i) to use cell culture, primary cells, nonhuman primate and human clinical models to study viral infection; (ii) to combine traditional histopathological, virological and biochemical approaches with functional genomics, proteomics and computational biology (haagmans et al., ); and (iii) to obtain signatures of virulence and insights into mechanisms of host defense response, viral evasion and pathogenesis (casadevaill et al., ) . for example, with the study of all respiratory viral diseases, a unifying hypothesis is that highly pathogenic respiratory viruses use both unique and common strategies to remodel the host cell to enhance virus replication, regulate disease severity and promote virus transmission (chang et al., ) . a highly significant new tool for studying these emerging viruses is next generation sequencing (ngs) which has already 'changed the way we think about scientific approaches in basic, applied and clinical research' to such an extent that 'the potential of ngs is akin to the early days of polymerase chain reaction (pcr), with one's imagination being the primary limitation to its use' (peng et al., ) . already, a good understanding of the 'timing' and extent of immune (innate)-mediated injury after virus infection has been achieved. furthermore, molecular 'disease' signatures associated with different pathogens in multiple animal species have been described at micro-rna, mrna, protein level, metabolite and lipid levels. such successful modelling of molecular events has made possible verifiable prediction about key nodes and bottlenecks, enabling the identification of novel host cell drug targets (diamond et al., ) . the translational impact of this research, in professor katze's view, will be immense, revealing a completely new and expanded host defense repertoire consisting of non-annotated noncoding rnas. despite all of these achievements, four crucial questions remain unanswered: (i) is systems biology too complicated and too expensive to become the pre-eminent approach in virology and immunology? (ii) are mathematicians and computer scientists up to the challenges? (iii) how will new technologies like next generation sequencing impact virus systems biology research, especially in the context of rna sequencing? (iv) how can new principal investigators best be identified and appointed? (virolab, ) . it has long been recognized that the emergence of any zoonoses is a complex process involving 'ecological interactions at the individual, species, community and global scale' (childs et al., , p. ) . this topic began with a presentation from professor a. a. aguirre that focused on the ecological framework in which any zoonotic disease should be considered. the role of bats as an important reservoir host for many dangerous zoonotic pathogens was then considered in some detail (cf. daniels et al., ; field et al., ; gonzalez et al., ; wang and eaton, ) . professor a. a. aguirre (department of environmental science and policy, george mason university and executive director, smithsonian-mason global conservation studies program, front royal, virginia, usa) presented emerging zoonotic diseases of wildlife: developing global capacity for prediction and prevention. he began by explaining that conservation medicine and more recently ecohealth have emphasized the need to bridge disciplines, thereby linking human health, animal health and ecosystem health under the paradigm that 'health connects all species in the planet' (aguirre et al., ) . in his view, the recent convergence of global problems such as climate change, biodiversity loss, habitat fragmentation, globalization, infectious disease emergence and ecological health demands integrative approaches breaching disciplinary boundaries. the international union for conservation of nature (iucn) maintains a red list of threatened species -an important initiative in view of the animal extinctions that have already occurred, of which . % were caused by disease (smith et al., ) . professor aguirre noted that the u.s. agency for international development (usaid) has been a major leader in the global response to the emergence and spread of highly pathogenic avian influenza (hpai). since mid- , it has programmed approximately $ million to build capacities in more than countries for monitoring the spread of hpai among wild bird populations, domestic poultry, and humans, and to mount a rapid and effective containment of the virus when it is found. recent analyses indicate that these efforts have contributed to significant downturns in reported poultry outbreaks and human infections and a dramatic reduction in the number of countries affected. furthermore, the usaid bureau for global health, office of health, infectious disease and nutrition (gh/hidn) recently funded two cooperative agreements, predict and respond, under its avian and pandemic influenza and zoonotic disease program to continue and expand this work. the goal of predict is to establish a global early warning system for zoonotic disease emergence that is capable of detecting, tracking and predicting the emergence of new infectious diseases in high-risk wildlife (e.g. bats, rodents and nonhuman primates) that could pose a major threat to human health. the goal of respond is to improve the capacity of countries in high-risk areas to respond to outbreaks of emergent zoonotic diseases that pose a serious threat to human health. the geographical scope of this expanded effort is directed to zoonotic 'hotspots' of wildlife and domestic animal origins (jones et al., ) . predict includes a program of smart (strategic, measurable, adaptive, responsive and targeted) surveillance that focuses on preventing the 'spilling over' from wildlife to humans or to halt these diseases rapidly after that spillover by understanding what factors induce emergence and rapidly identifying ways of prevention, control, and mitigation. the overall aim of smart is to promote an integrated, global approach to emerging zoonoses. this integration requires commitment from a broad coalition of partners and stakeholders including government agencies, universities and non-governmental organizations, collaborating for specific purposes and to generate in the future new international structures able to respond to these emerging zoonoses. with . billion animals being imported into the united states each year, as well as an extensive international trade in illegal animal exports ) and some % of emerging zoonoses worldwide having wildlife origins, professor aguirre stressed that ecohealth has become a necessity, not an optional policy goal. dr. g. a. marsh and his colleague dr. l.-f. wang (australian animal health laboratory [aahl], geelong, victoria, australia) began their presentation, bats: a mixed bag of new and emerging viruses, by pointing out that the ''old'' bat viruses were represented by many zoonotic pathogens, including rabies virus, yellow fever virus, st louis and japanese encephalitis viruses, and west nile virus. now bats have been identified as natural reservoirs for a number of new and emerging viruses -ebola virus, marburg virus, hendra virus and sars-like coronaviruses. there are some different bat species; and they often roost in high-density colonies of over one million flying mammals, which have, in a very real sense, been travelling for millions of years, exposing themselves to many pathogens; therefore, the resulting complexity is not surprising. key research questions include (i) why do bats seem to be able to co-exist with a great diversity of viruses without showing disease signs? (ii) what triggers the spillover of bat viruses into other animals? (iii) do bats control viral infection differently from other mammals? attempts to isolate viruses from bats have generally been unsuccessful. therefore, in an effort to improve the success rate for virus isolation, dr. marsh and his team have recently developed primary cell culture lines from numerous different species of bats (crameri et al., ) . the use of these bat cell lines, in combination with improved sampling techniques, has lead to recent isolation of hendra virus from a number of bat urine samples collected in several locations across queensland, australia, including those associated with human and horse virus spillover events (smith et al., ) . furthermore, this henipavirus surveillance program has led to the isolation of a number of novel viruses from two different virus families, whose zoonotic potential is not yet known. in an attempt to understand virus/host interactions, as well as to provide insight into the key factors involved in future spillover events, aahl has launched a number of international collaborative projects in south-east asia and ghana, west africa. c. kohl (sonntag et al., ) . the phylogenetic analysis of the genome sequence of bat adv- demonstrated a close relationship to canine adenovirus and (cadv- and cadv- ) (kohl et al., ) . the very similar genome organization supported the hypothesis of a shared ancient ancestor. interestingly, both cadvs are presenting untypical pathological features within the family adenoviridae. these adenoviruses were found to have an unusually broad host range and are causing a rather higher pathogenicity in a variety of carnivore hosts. the untypical pathological features might be understood as signs of a missing adaptation host and could provide a model to study ancient inter-species transmission events. this section of the conference addressed cross-species transmission of selected pathogens. in addition to the summaries below of three presentations on this topic, this special supplement includes an article, epidemiological survey of tryanosoma cruzi infection in domestic owned cats from the tropical southeast of mexico by dr. m. jiménz-coello et al. setting out how a significant public health problem in mexico has been caused by the crossspecies transmission of american trypanosomiasis (at) from triatomine bugs to domestic cats, representing a potential risk to humans. speaking on behalf of an extensive team of collaborators from a number of institutions -c. osborne, p. cryan, t. j. o'shea, l. m. oko, c. ndaluka, c. h. calisher, a. berglund, m. l. klavetter, r. a. bowen and k. v. homes -dr. s. r. dominguez (section on pediatric diseases, the children's hospital, university of colorado school of medicine, aurora, co, usa) began by noting that the first pandemic of the twenty-first century, the deadly sars virus, had its natural reservoir in bats. in his presentation, alphacoronaviruses in new world bats: prevalence, persistence, phylogeny and potential for interaction with humans, he suggested that bat coronaviruses (covs) may well be the ancestors of all group and covs. today bats had become a primary species encountered by humans in terms of potential exposure to significant disease agents. their research was tackling three important unanswered questions: (i) what is the prevalence and diversity of bat covs in new world bats? (ii) do bat covs persist in bat populations and/or individual bats? (iii) what are the potential interactions of infected bats with the human population? a -year study (osborne et al., ) had collected clinical and environmental samples from bats at rural sites and urban sites throughout colorado, as well as bat carcasses obtained from various counties throughout the state from the colorado department of public health and environment. of the , faecal or anal swab samples, , that is, %, were positive for cov rna. the highest prevalence of the virus was in juvenile bats; although rates of prevalence varied from year to year, late spring was the time when the virus peaked. although bat covs persisted within bat populations and their roosts, individually tagged cov-infected bats cleared their infections within weeks without apparent illness. new world bats of the same species in geographically distinct locations and over the course of several years harbour similar covs, and some new world bat covs may be able to infect bats of different genera. strikingly, bats, which had known or potential contact with humans, had a high prevalence of - % of cov infection. it is clear that significant opportunities exist for zoonotic transmission of coronaviruses from bats to humans and vice versa, especially as more than viruses have already been isolated from or detected in bat tissues. noting that many mammalian and avian species in addition to bats are susceptible to coronavirus infection, receptor proteins that include ace , apn and cea-cam . the recent emergence of sars coronaviruses from civets, bats and/or other reservoir species into humans depended upon a few amino acid substitutions in the receptor-binding domain (rbd) of s from the animal viruses that allowed them to recognize human ace instead of, or in addition to, receptors of their natural hosts (li, ) . alphacoronaviruses of pigs, cats, dogs and human coronovirus e use apn receptors of the host species, and all four viruses recognize feline apn (tusell et al., ) . in contrast, for human alphacoronavirus nl , the receptor-binding motif (rbm) with its three loops in the rbd binds specifically to human ace . in the rbds of the cat virus, fipv, professor holmes and her research team predicted three loops structurally similar to the nl rbms, and they constructed chimeric fipv rbds containing one, two or three rbms from nl . receptor-binding assays using enzyme-linked immunoassays (elisa), flow cytometry and co-immunoprecipitation identified three loops (rbms) in fipv rbd that are required for binding to feline apn. furthermore, substitution of only a few key amino acid residues within the rbms of fipv altered apn specificity and viral host range. thus, the emergence of alphacoronaviruses into new host species can occur when spontaneous mutations arise in the rbms that permit binding to variants of the apn receptor protein expressed by different host species. considering the interaction between human and swine h n viruses since , professor h. d. klenk (institute of virology, philipps university, marburg, germany) presented the mechanisms of pathogenicity and host adaptation of influenza viruses in the light of the new h n pandemic. he explained that there was now a clear scientific consensus that wild aquatic birds are the natural hosts for a large variety of influenza a viruses. occasionally these viruses are transmitted from this reservoir to other species, such as chickens, pigs and humans, leading to devastating outbreaks in domestic poultry and the possibility of human influenza pandemics. by the end of february , there had been , deaths, with the world health organization later confirming cases in countries and territories, with deaths in at least countries and territories before the spread of the h n virus diminished. however, professor klenk set out the evidence to support his view that the pathogenic and pandemic potential of this new h n virus is not yet exhausted. the host range and pathogenicity of any virus are polygenic traits depend on the interaction of different viral proteins with specific host factors. it has long been known that proteolytic activation and receptor specificity of the hemagglutinin (ha) are important determinants for pathogenicity and interspecies transmission, respectively. there is now considerable evidence that ha mutations altering receptor specificity and cell tropism of the pandemic influenza a virus (h n v) are linked to the d g amino acid substitution and are associated with a particularly severe outcome of infection (liu et al., ) . it should be remembered that the viral polymerase has to enter the nucleus of the infected cell to promote replication and transcription of the viral genome. adaptive mutations in polymerase subunits of avian viruses improve binding to importin alpha, a component of the nuclear pore complex in mammalian cells. as a result, nuclear transport of these proteins and efficiency of replication are enhanced. thus, the interaction of the viral polymerase with the nuclear import machinery is an important determinant of host range. some of the structural features typical for avian viruses have been preserved in the polymerase of the pandemic influenza a virus (h n v) suggesting that this virus has the potential to further adapt to humans. recent studies have shown that the ns protein, another important determinant of pathogenicity and host range, is sumoylated and that this modification enhances virus growth. interestingly, ns of h n v is not sumoylated (xu et al., ) . taken together, these observations support the view that the pathogenic and pandemic potential of the new virus is not yet exhausted. furthermore, because of the firm evidence of ha polymorphism in position , mutants and other mutations with altered receptor specificity will have to be closely monitored. in the subsequent discussion, it was noted that when a virus becomes highly pathogenic, this might block its spread if additional hosts are not readily available. furthermore, the role of co-infection with bacterial inflection was highly relevant in the - influenza pandemic and might well be relevant in a future pandemic. there have been at least three influenza pandemics every century since , with some evidence of earlier epidemics and pandemics after . in the cambridge world history of human disease, a. w. crosby ( ; p. ) has noted that although the black death and world wars i and ii killed higher percentages of the populations at risk, the - influenza pandemic was possibly 'in terms of absolute numbers, the greatest single demographic shock that the human species has ever received'. the summaries below of seven presentations on this topic highlight the diversity of influenza viruses in north america (cf. nelson et al., ) , while other relevant research has been published with respect to swine influenza viruses (sivs) in europe (kyriakis et al., ) . considerable research has now been carried out into how the highly pathogenic h n avian influenza virus spreads from wild birds and ducks to chickens and other species, including humans (rabinowitz et al., ; ma et al., ) . the studies of how influenza viruses can be genetically altered to become more transmissible have become a matter of much controversy palese and wang, ) . in addition, to the summaries below, this special supplement includes an article, lessons from emergence of a/goose/guangdong/ -like h n highly pathogenic avian influenza viruses and recent influenza surveillance efforts in southern china, in which dr. x.-f. wan has considered the emergence and ecology of influenza a viruses in southern china, especially the highly pathogenic h n virus. backed by an extensive team of collaborators, professor a. d. m. e. osterhaus (head, department of virology, erasmus medical centre, rotterdam, the netherlands) began his presentation, emerging and neglected influenza viruses, by explaining the complex aetiology of the influenza a, b and c viruses. while humans can serve as host species for all three viruses, influenza a can also be present in other mammals and avian species, influenza b in seals and influenza c in pigs. the severity of the disease is relatively high with influenza a, moderate with influenza b and low with influenza c, with the prevalence in humans high with both influenza a and b viruses, but lower with influenza c. furthermore, a clear distinction needs to be made between seasonal influenza, avian influenza and pandemic influenza. there are two different mechanisms of host adaptation -sequential mutations and genome reassortment. most recently, the new h n swine flu pandemic outbreak of drew attention to the speed with which an influenza virus could move around the world. however, the fact that this particular virus was not as virulent as first anticipated proved crucial in confronting the virus, even though it spreads rapidly among humans, unlike the much more virulent h n avian flu virus, from which more than people have died from more than verified cases from to (world health organization (who), ). although clinical evidence of h n avian influenza appears predominantly in diving ducks, a number of dabbling duck species -mallard, teal, wigeon and gadwall -appear to spread h n , generally acquired from wild birds, without showing major signs of disease. the likelihood of a major pandemic linked to h n has not decreased in the last years, even though publicity has certainly decreased. furthermore, professor osterhaus pointed out that the recent h n pandemic influenza outbreak indicated that the scientific community was wrong in its earlier belief that 'a pandemic strain could only arise from a subtype that had not previously been widely disseminated in humans [because] the h n virus has shown that human varieties characterized by different hemagglutinin (ha) molecules may follow separate lines of evolution and may generate potentially pandemic strains within an existing human ha subtype. hence, it is essential to develop methods for estimating how many antigenically different subtypes may reside within each ha type' (cf. rappuoli et al., ) . in the light of the continuing prevalence of many subtypes of influenza, there is a critical need for improved monitoring, especially in asia and africa, as part of a move from a reactive to a proactive approach, with greater research into the possibility of developing a universal vaccine. although there are increasing opportunities for virus infections to emerge and spread rapidly in our global society, new tools are being provided by research in molecular biology, epidemiology, genomics and bioinformatics. already early warning systems based on state of the art virus detection techniques, as well as targeted intervention strategies based on data about the mutual virus-host interaction have been instrumental in dealing with numerous viral threats, including sars and avian influenza. the extensive research of the department of virology at erasmus medical centre in rotterdam was highlighted by a further presentation, influenza pneumonia: the role of the alveolar macrophage, given by dr. d. van riel. highly pathogenic avian influenza (hpai) h n virus causes severe, often fatal, pneumonia in humans. the pathogenesis of hpai h n virus is not completely understood, although the alveolar macrophage (am) is thought to play an important role. the am resides in the pulmonary alveolus, the primary site of hpai h n virus replication in humans. it had been shown previously that hpai h n virus attaches abundantly to these am (van riel et al., ) . the aim of this study was to determine the response of primary human am to hpai h n virus, seasonal h n virus or pandemic h n virus, and to compare these responses with that of macrophages cultured from monocytes. hpaiv h n infection of am compared with that of macrophages cultured from monocytes resulted in a lower percentage of infected cells (up to % versus up to %), lower virus production and lower tnf-alpha induction. infection of am with h n or h n virus resulted in even lower percentages of infected cells (up to %) than with hpai h n virus, while virus production and tnf-alpha induction were comparable. in conclusion, this study revealed that macrophages cultured from monocytes are not a good model to study the interaction between am and influenza viruses. furthermore, the interaction between hpai h n virus and am could contribute to the pathogenicity of this virus in humans, because of the relatively high percentage of infected cells rather than virus production or an excessive tnf-alpha induction (van riel et al., ). one virus of each pair was wild type, while the other carried the h y na mutation conferring resistance to na inhibitor oseltamivir. within each pair, the wild-type and oseltamivir-resistant virus caused disease of equal severity in ferrets and replicated to comparable virus titers in the upper respiratory tract. then, to assess the fitness of drug-resistant h n influenza viruses, the research team considered virus-virus interactions within the host by co-inoculating ferrets with mixtures of the oseltamivirsensitive and oseltamivir-resistant h n viruses in varying ratios (e.g. / ; / ; / ; / ; / ). using this novel approach, they demonstrated that the proportion of a/vietnam/ / -h y clones tended to increase, while the proportion of a/turkey/ / -h y clones tended to decrease. their findings suggest that the h y na mutation can affect the fitness of two h n viruses differently and is dependent on background na sequence. dr. govorkova pointed out that antigenic and genetic diversity, virulence, the degree of na functional loss of h n virus and differences in host immune response can also contribute to such differences. therefore, the risk of emergence of drug-resistant influenza viruses with uncompromised fitness should be monitored closely and considered carefully in pandemic planning. in a collaboration with c. corzo, k. juleen and m. gramer they initiated an active surveillance program in healthy pigs in multiple sites in , during a period coincident with the emergence of the h n pandemic in humans. their study, active surveillance for influenza viruses in north america, presented an analysis from months of data which indicated that similar viruses can be detected in both active and passive surveillance schemes and that there has been an explosion of diversity in swine influenza viruses (siv) in the united states. not only were a number of pandemic h n infections in swine detected, but a number of pandemic/endemic swine virus reassortants were found, albeit from healthy animals (ducatez et al., ) . virologically, the pattern of disease surveillance grounded in the activities of state diagnostic laboratories collecting information from diseased animals is representative; however, epidemiologically this data from diseased animals is not representative. reverse zoonoses have had a huge impact on siv in the united states (vincent et al., ) , and the pandemic virus is now endemic. however, in considering whether any particular reassortment causes alarm, it must be acknowledged that there is not yet a good model of risk, so h , like h , is going to be found in pigs for some time to come, but the consequences of this diversity in siv are not yet clear. the extensive collaboration now taking place in the study of swine influenza was evident in the presentation vessel pendulum began by explaining the three elements of how swine could be considered as a mixing vessel for influenza a viruses as formally proposed by scholtissek et al. ( ) : (i) swine are susceptible to infection with influenza a viruses from avian and human viruses; (ii) the avian viruses can adapt within the pig, producing novel reassortants; and (iii) these reassortants can then be shed and are infectious to man. the goal of this presentation was to test the first part of the mixing vessel hypothesis, concerned with the susceptibility of swine to avian and human influenza viruses, making use of both mixing vessel studies in pigs and genetic markers to investigate adaptation. dr. lager noted that the emergence of the h n highly pathogenic avian influenza virus that can transmit from avian species directly to man, and the presumption that the h n influenza jumped from birds to man has expanded our understanding of the swine mixing vessel hypothesis as a potential, but not exclusive, source of human pandemic viruses (taubenberger et al., ) . moreover, the emergence of the pandemic h n virus has re-emphasised swine as a potential source of pandemic virus. in this study, all of the challenge viruses (avian h , h , h ) induced a similar effect in pigs; challenge viruses did replicate in pigs; the infections were subclinical with mild pneumonias; most infections resulted in seroconversion; and none of them transmitted to contact controls. this series of studies suggests pigs could be easily infected with avian viruses; however, an adaptation step is needed to generate fit viruses that transmit among swine. parallel studies are currently underway testing the susceptibility of pigs to human seasonal influenza viruses. future studies using reverse genetics could investigate potential genetic markers for adaptation of avian viruses to swine which may provide insight into the interspecies transmission of influenza viruses. a in this study, an attempt was made to recreate the pandemic virus by co-infecting cells (in vitro) or a group of pigs (in vivo) with eurasian (sp ) and north american triple reassortant (ks ) sivs (ma et al., a) . infected pigs were co-housed with two groups of sentinel animals to investigate virus maintenance and transmission. the origin of each gene segment of viruses was determined, which were isolated from supernatants collected from co-infected cells or nasal swabs and bronchioalveolar fluid samples collected from infected and sentinel animals. different reassortant viruses were identified from co-infected cell lines; however, no virus with the genotype of ph n was found. less reassortant viruses were found in the lungs of co-infected pigs in contrast to those in co-infected cells. interestingly, only the intact ks was detected from nasal swabs from the second group of sentinel pigs. these results demonstrated that multiple reassortant events can occur within the lower respiratory tract of the pig; however, only a specific gene constellation is able to be shed from the upper respiratory tract. however, in this study, it was not possible to generate the ph n constellation using co-infection with the techniques described above and previously (ma et al., b) . in . she began by reflecting on the ability of swine to act as a reservoir for many influenza viruses, becoming infected with low mortality, regardless of influenza virus strain. the objective of the study was to further understand the porcine response to influenza and to compare this response to other animals infected with the same virus. to accomplish this objective, they used statistical and functional analysis of global gene expression to compare host transcriptional response during acute infection by a contemporary h n pandemic influenza virus (a/california/ / ) in swine, non-human primates and mice. using their data, they compared and contrasted the biological pathways most significantly associated with gene expression changes during acute infection across these species. their goal was to leverage data collected in their previous studies (ma et al., ; safronetz et al., ) to better understand influenza virus pathogenesis through a cross-species analysis that considered three crucial questions: (i) which genes change over the course of acute infection? (ii) what are the top functions altered during infection? (iii) how does functional response compare across the three species? despite challenges to data integration and interpretation, including the differences in transcript representation and annotation on the microarrays for the different species, the researchers found notable differences in response to influenza in the lungs of the three species. although similar functional groups of genes changed with infection in all three species, the nature of that response was species specific. swine exhibited an elevated transcriptional response that tapered by resolution of influenza. mice exhibited a decrease in many acute phase and immune response genes quickly followed by a steady increase in expression. host response in macaques was most pronounced and maintained over time. in considering the transcription of immune-related genes in swine, mice and nonhuman primates, they found that although the number of immune-related genes changing in each species was similar, the precise genes changing were very different, with only immune response genes commonly differentially expressed across all three species. this suggested that the nature of immune response within each species may be quite different. in response to the perennial question after any scientific experiment, ''where do we go from here?'' they offered four ideas: (i) time series analysis could reveal unique response kinetics across species, thereby leading to targeted analysis; (ii) data integration across multiple data types, including transciptomics, proteomics, mirna and ngs could generate a more complex, multidimensional view of response; (iii) as annotation of the different species-specific genomes improves, this information could be integrated into future analyses, making a better understanding of the biological responses to infection possible; and (iv) the gathering of this additional information could empower more precise analysis on what makes each species uniquely susceptible or resistant to influenza. in the firm view of these particular six researchers, studies such as this are necessary for a deeper understanding of influenza pathogenesis and demonstrate the utility of systems biology in the study of emerging viruses. three relevant articles on this topic have been published below, highlighting the global dimensions of both infection and treatment, no matter where the virus first emerges. the need for geographical comparative studies of the emerging hantavirus, puumala hantavirus (puuv), has already been indicated by professor henttonen and his team in their presentation summarized earlier in the opening topic of this meeting review. in a further investigation into the same hantavirus, dr. eckerle and her colleagues have presented an article within this special supplement entitled atypical severe puumala hantavirus infection and virus sequence analysis of the patient and regional reservoir host. in this article, they focus on the difficulties in the diagnosis of and treatment for a single patient and performed virus sequence analysis showing regional clustering in reservoir and host. in their more wide-ranging conference presentation, they investigated cytokine expression in a cohort of patients hospitalized with acute severe hantavirus infection during an epidemic in germany in (cf. faber et al., ) . elevated proinflammatory cytokines during the early phase of disease compared to healthy controls and increase in immunosuppressive tgf-b from early to later phase of disease supported the hypothesis of an immune-mediated pathogenesis of puumala hantavirus (sadeghi et al., ) . this finding indicates that the immune status of the host for old-world hantaviruses plays an important role, not only the virus itself. in a further article published in this special supplement, how ebola virus counters the interferon system, a. kühl and s. pöhlmann have reviewed which components of the innate immune system could be effective against the zoonotic transmission of ebola virus (ebov) to humans, which results in severe haemorrhagic fever and high case-fatality rates. their focus is on how the interferon (ifn) system, as a key innate defense against viral infections, is targeted by distinct ebov proteins, and on how specific effector molecules of the ifn system could form a potent barrier against the spread of ebov in humans. finally, in lassa fever in west africa: evidence for an expanded region of endemicity, dr. n. sogoba and his colleagues h. feldmann and d. safronetz have stressed the importance of increased surveillance for lassa virus across west africa. the seven presentations summarized below cover a number of haemorrhagic fever viruses. for example, an important example of a highly contagious and life-threatening haemorrhagic fever virus is crimean-congo haemorrhagic fever virus (cchfv), caused by a tick-borne virus of the bunyaviridae family (elliott, ) , first recognized in the crimea in , with an identical virus isolated in the congo in ; the incidence and geographical spread of this disease with its high human fatality rate have increased significantly in the past years. however, the causes of this increase are not yet clear (maltezou and papa, ) . in the light of the need to develop new therapies and effective, safe vaccines, the next seven research presentations could prove to be of considerable significance, not only for cchfv, but also for the hendra, nipah, lujo and ebola viruses. although these viruses have certain common features in their causes and consequences, each haemorrhagic fever virus needs to be carefully studied as a distinct entity. dr (peyrefitte et al., ) . moreover, it has already been shown that cchfv causes liver damage in infected patients and in the animal model (bereczky et al., ) . the research objectives were to consider: (i) how does cchfv affect hepatocarcinoma cell lines? (ii) is cchfv able to enter and replicate into these cell lines? (iii) does cchfv modulate the in vitro cellular response? to better understand the cchfv pathogenesis in liver cells, they analysed in vitro the host response induced after cchfv infection in huh (unable to produce ifn-beta) and hep-g (capable of producing ifn-beta) cell lines. they noticed that while in huh , cchfv infection elicited at day a cytopathogenic effect, no visible effect was seen in cchfv-infected hepg . this intriguing feature led them to analyse the viral parameters expecting a differential cellular response. both cell lines were shown to be permissive to cchfv and with a high viral yield as monitored by plaque titration assay, genomic and antigenomic strand quantification. these cchfv-infected hepatocarcinoma cell lines induced only il- secretion. in addition, a pro-apoptotic effect was observed in huh but not in hepg . interestingly, no type-i ifn was detected for hep-g during the kinetic study, suggesting a strong inhibition of ifn secretion. they concluded that cchfv does enter and replicate in hepatocytes and that hepatocytes could be involved in cchf pathogenesis associated with antigen presenting cells for cchfv dissemination. while cchfv did not induce ifn-beta secretion in hepatocyte cell lines, cchfv did induce the secretion of il- in hepatocyte cell lines. furthermore, cchfv induced a higher secretion of il- in the apoptotic huh cell line than in the nonapoptotic hep-g cell line. thus, this research indicated that il- production and apoptosis seemed to be markers of cchfv pathogenesis in hepatocyte cell lines. professor t. w. geisbert (university of texas, medical branch, galveston, tx, usa) presented an evaluation of countermeasures against hendra and nipah viruses in nonhuman primate models. he pointed out that the henipaviruses, hendra virus (hev) and nipah virus (niv) are enigmatic emerging pathogens that can cause severe and often fatal neurologic and/or respiratory disease in both animals and humans. guinea pigs, hamsters, ferrets and cats have been evaluated as animal models of human hev infection. a research team led by professor geisbert recently evaluated african green monkeys as a nonhuman primate model for henipavirus infection and discovered that they are the first consistent and highly susceptible nonhuman primate models of hev and niv infection rockx et al., ) . the severe respiratory pathology, neurological disease and generalized vasculitis manifested in both hev-and nivinfected african green monkeys provides an accurate reflection of what is observed in henipavirus-infected humans. these nonhuman primate models were then employed to evaluate several post-exposure treatments including ribavirin (which did not work) and a human anti-henipavirus monoclonal antibody (which was successful). dr the research was motivated by the awareness that neutralizing antibodies are probably the major effectors against this viral infection. the rationale of using rv vectors for the development of a niv vaccine was fourfold: (i) rv-vectored vaccines are not pathogenic regardless of the route of administration or the immune status of the host; (ii) rv-based vaccines are very efficacious even after a single immunization by the oral route; (iii) rv-based vaccines have the ability to target macrophages and dendritic cells, to induce th t-cell response and are capable of inducing long-lasting immunity; and (iv) postexposure prophylaxis using recombinant rv vaccines is very effective, even when the cns is already infected (faber et al., a,b) . the niv g gene was inserted into the non-pathogenic rv vectors spbaangas or spbaangas-gas, resulting in spbaangas-ng or the double gas variant spbaan-gas-ng-gas, respectively. further research led to four significant conclusions: (i) there are no detectable amounts of niv g present in recombinant nivg-rv particles; (ii) the presence of an niv g gene does not increase, but rather decreases the pathogenicity of the recombinant viruses; (iii) priming with nivg-rv triggers a strong niv g-specific memory response, which correlates inversely with vaccine concentration used for the priming; and (iv) a single immunization with nivg-rv is probably sufficient to protect against a niv challenge infection. arenaviruses are rodent-borne bisegmented ambisense rna viruses, which include lassa fever virus, lymphocytic choriomeningitis (lcm) and tacaribe the index case for this acute febrile illness virus was a travel agent living on a farm during in lusaka, zambia, who infected a local cleaner, as well as a paramedic and a nurse in johannesburg, south africa, all of whom died, with the paramedic infecting a further nurse who was treated with ribavirin and survived . the name of the virus originated from the first two letters of the two key cities, lusaka and johannesburg. four of the five infected persons died of haemorrhagic fever-like symptoms paweska et al., ). viral genome sequencing revealed that this virus differed from other arenaviruses by at least % and is highly pathogenic, with a case fatality rate (cfr) of % paweska et al., ) . in view of the uniqueness and high virulence of lujo virus (ljv), the research team developed a reverse genetics system to study the molecular characteristics of this novel arenavirus. this system will facilitate studies of ljv biology, development of antiviral screening assays and pathogenesis studies in animal models. t. cutts (national microbiology laboratory, public health agency of canada, canadian science centre for human and animal health, winnipeg, manitoba, canada) with his colleagues s. theriault (chief, applied biosafety research program, same centre) and g. kobinger (chief, special pathogens program, same centre) presented cytofixÔ inactivation of veroe cells infected with zaire ebola virus (zebov) both in vitro and in vivo. first, it was pointed out that removing infected tissues from high-containment laboratories requires implementation of a number of different decontamination techniques to render the organism inert and is subject to flexibility according to the laws of the country in which the laboratory is located. according to the canadian biosafety guidelines th edition, an organism may be removed from containment once it has been rendered inert, but no procedure is in place to validate these biosafety guidelines, and it is up to the individuals to implement the relevant guidelines (public health agency of canada, , p. . chap. . . ). methods such as gamma irradiation, formalin fixation, acetone and methanol permeation, plus the use of various other chemical agents, are common practices to preserve cellular tissue or blood components and to inactivate organisms (elliott et al., ; mitchell and mccormick, ; preuss et al., ; villinger et al., ; sanchez et al., ) . such methods still raise questions as to their effectiveness or their redundancy. furthermore, these inactivation steps can lead to the alteration of the target organism possibly affecting the qualitative and quantitative results. the focus of the applied biosafety research program was to evaluate and develop technologies and procedures relevant to biocontainment in the context of the laboratory, as well as to prevent unintentional and intentional release of dangerous organisms into the environment. using the commercial product, cytofix/cytoperm tm from bd biosciences, this research sought to inactivate vero e cells which had been infected with the deadly zaire ebola virus (zebov). the aim of the research was to determine the effectiveness and duration of cytofix/ cytoperm for fixing the cellular material infected with zebov. the veroe cells were infected with the wildtype zebov and a mouse adapted zebov(mazebov) and assayed after a -min and -min exposure to cyto-fixÔ followed by neutralization. samples of blood from a non-human primate infected with zebov were drawn at dpi and assayed for effectiveness in the same manner as the in vitro studies with cytofixÔ. in addition, vero e cells infected with mazebov were treated in the same manner and injected into balb/c mice to compose the in vivo studies. cytoxicity and neutralization assays were used to determine the effect (if any) the treatment had on both the virus and the health of host cells. results of the tissue culture tcid assay showed that a -min exposure to cytofixÔ inactivated a large portion of the cells containing infectious virions, while after a -min exposure, no detectable levels of virus were observed. blood samples from the non-human primates showed similar results to the cell culture assay having no detectable virus from infected cells after min of exposure. in vivo studies with mice showed that both a min and -min exposure time to cytofixÔ had a % survival rate after days post-infection, while the positive controls succumbed after to dpi. because laboratories differ in their preferences of technique, the time of inactivation also varies. what this research demonstrated was the effectiveness of a quick procedure of min for inactivating viruses within cells infected with zebov, thereby rendering organisms safe to remove from containment. has not yet been linked with disease in humans, the presence of antibodies against rebov in people working closely with infected macaques and swine indicates that humans can be infected with this virus (miller et al., ; miranda et al., ; barrette et al., ). however, research has been hampered by the fact that the only available disease model for rebov to date has been cynomolgus macaques. seeking new rebov disease models, the research team assessed various rodent models -the balb/c mouse, hartley guinea pig, syrian hamster and stat )/) mouse that lacked the signal transducer and activator of transcription (durbin et al., ) . although virus replication occurred in guinea pigs and hamsters, progression to disease was only observed upon inoculation of stat )/) mice. despite certain drawbacks set out in the journal article, the stat )/) mouse can be used to investigate the determinants of differences in pathogenicity in various rebov strains, as well as to assess vaccination and antiviral therapies (miller et al., ; miranda et al., ; durbin et al., ; barrette et al., ; de wit et al., ) . the unity of human, animal and ecosystem health outlined by professor aguirre, as well as the interactions among multiple tick-borne pathogens in a natural reservoir host set out by professor fish and his research team, both summarized in topic above, highlight the necessity of cross-disciplinary collaboration in studying zoonotic bacterial diseases (daszak et al., , pp. - ) . such collaboration is especially important in studying tick-borne infectious disease, which emerged so extensively in the united states during the last three decades of the twentieth century (paddock and yabsley, , p. ) . now, in an article published in this special supplement, beyond lyme: etiology of tick-borne human disease with emphasis on the southeastern united states, drs. stomdahl and hickling have explained that tick distributions are in flux, especially in the south-eastern united states, requiring health providers to think 'beyond lyme' to identify the specific tick species that bite humans and the different pathogens these ticks carry. in an international context, drs. wood and artsob have set out the increasing importance of travel-associated rickettsioses in their article, spotted fever group rickettsiae: a brief review and a canadian perspective. in a third article published in this special supplement, drs. verma and stevenson present an article on epidemiology of leptospirosis with its one million cases worldwide. in leptospiral uveitis -there's more to it than meets the eye! they hypothesize in detail about how the eye inflammation uveitis is triggered and stress the impact that 'understanding how this bacterium is able to induce this inflammatory process will be a key to the better management and prevention of the disease'. this continuum of basic research leading to understanding a disease and then to managing that disease and finally to preventing it offers a pattern of scientific discovery that is relevant to many other emerging zoonotic diseases. opening his presentation, the foodborne pathogen campylobacter jejuni exploits mammalian host cell receptors and signaling pathways, professor konkel noted that the per cent of c. jejuni isolates that are resistant to antibiotics is continuing to increase and that c. jejuni infections are frequently associated with serious sequelae, including guillain-barré syndrome. it is well understood that infection with c. jejuni is often a consequence of eating foods contaminated with undercooked poultry. however, c. jejuni pathogenesis is a highly complex process that is dependent on many factors including motility, adherence, cell invasion, protein secretion, intracellular survival and toxin production. acute illness, characterized by the presence of blood and leucocytes in stool samples, is specifically associated with c. jejuni invasion of intestinal epithelial cells. dissecting bacteria-host cell interactions are critical to understanding the infection caused by c. jejuni. previous work has shown that maximal invasion of host cells by c. jejuni is dependent on synthesis of the c. jejuni cadf and flpa fibronectin (fn) binding proteins and requires the secreted campylobacter invasion antigens [cia(s)] (larson et al., ) . to test the hypothesis that maximal cell invasion requires specific signalling events, binding and internalization assays were performed in the presence of numerous inhibitors of cell signaling pathways. the research team found that c. jejuni cell invasion utilizes components of focal complexes (fcs), as invasion is significantly inhibited by wortmannin (an inhibitor of pi- kinase) and pp (a c-src inhibitor). they further demonstrated that a wild-type strain of c. jejuni results in the activation of the rho gtpase rac . these observations are consistent with the proposal that c. jejuni binding to host cell-associated fn and secretion of the cia proteins trigger integrin receptor activation, which in turn promotes intracellular signalling and actin cytoskeletal rearrangement. on the basis of these data, they concluded that c. jejuni utilizes a novel mechanism to promote host cell invasion. the research findings professor konkel presented were recently published in cellular microbiology (eucker and konkel, ) . simple, fast and specific tests for pathogen identification are essential for epidemiological investigation of numerous diseases. within the field of immunodiagnostics, a quantitative determination of either antibody or antigen by antigen-antibody interaction can be made by lateral flow tests (also known as a dipstick or rapid tests). dr. e. baranova and her colleagues p. solov'ev, n. kolosova and s. biketov (all state research center for applied microbiology, obolensk, russia) began the presentation, development of lateral flow tests for the fast identification of zoonotic disease agents, by pointing out that lateral flow (lf) tests can be used in the field, as a diagnostic tool that produces results that can be read visually by the naked eye within min after sample application. the creation of an algorithm for the development of an appropriate lf test to identify biopathogens requires the development of a target antigen, obtaining specific antibodies (biketov et al., ) and then creating a lf-test formulation to be trial tested. the target antigens must have the ability to induce species-specific antibodies, as well as be characterized by surface localization with multiple epitope presentation on the surface. the antibodies need to have a specificity and sensitivity sufficient for application in the lf detection format, as well as the capacity to be preserved after labelling with gold particles and after immobilization on a surface. over a period of months, the research team developed and tested in the field lf tests for the detection of bacillus anthracis, which causes anthrax, yersinia pestis, which causes bubonic plague, and francisella tularensis, which is the causative agent of tularaemia (or rabbit fever). all three of these lf tests have now been made available as commercial products and are being used throughout russia for the rapid identification of these dangerous pathogens. drs. j. d. trujillo and p. l. nara (center for advanced host defences, immunobiotics and translational comparative medicine, iowa state university, ames, iowa, usa) have developed and validated a new approach to the diagnosis of infectious agents. dr. trujillo explained that they are employing novel polymerase chain reaction (pcr)-based methods for the detection and differentiation of current and emergent mycoplasma species relevant to human and animal medicine and biodefense. their presentation, titled novel sybr Ò real-time pcr assay for detection and differentiation of mycoplasma species in biological samples from various hosts, began by explaining the relevance of mycoplasma species, which are endemic, strict or opportunistic pathogens in human and animal medicine. moreover, mycoplasma species are important re-emerging pathogens and foreign animal diseases. importantly, mycoplasma species are difficult to culture or are un-culturable, and thus are difficult to impossible to detect by conventional diagnostic methods. moreover, current pcr methods have limited breath of species detection and differentiation, requiring the use of species-specific assays that are costly and time-consuming. their goal was to develop a pilot mycoplasma genus diagnostic assay to validate the novel application of high-resolution melt (hrm) methodology for rapid, sensitive and cost-effective detection and differentiation of various pathogenic mycoplasma species. dr. trujillo presented the validation and utilization of sybr Ò green dye in real-time pcr (qpcr) mycoplasma detection and differentiation assay (panmyco qpcr). this pcr assay utilizes primers specific for this genus (modified from s. c. baird et al., ) . this pcr assay results in the generation of small dna fragments of various base pair lengths called pcr amplicons. each amplicon has a melt temperature (tm) that is determined following qpcr. sequence of amplicon representative of the mycoplasma species present defines the melt temperature (tm) and allows for the use of amplicons tm in species identification with limited resolution and excellent sensitivity. the panmyco qpcr assay has similar sensitivity to a conventional nested pcr assay for mycoplasma bovis with a linear detection range of one colony forming unit (trujillo et al., ). additional work presented described increasing species resolution of this assay, by defining unique melt profiles for each mycoplasma species amplicon utilizing precision melt software from biorad, ca, usa to perform hrm analysis. greater than different species of mycoplasma found in bovine, caprine, ovine, avian and porcine hosts have been characterized with the panmyco qpcr and hrm analysis. occasionally, this testing has resulted in the detection of multiple species in a single sample or discovery of novel or emergent mycoplasma species. this data analysis method allows for the sensitive detection and rapid differentiation of numerous mycoplasma species in many different hosts. dr. trujillo concluded that this novel real-time pcr assay can detect and potentially differentiate all known mycoplasma species. moreover, this presentation demonstrated the novel use of genus-specific sybr green pcr and hrm analysis for the detection, differentiation and discovery of medically important pathogens. several additional translational research projects have been launched to demonstrate the importance and utility of the pan myco qpcr assay in the context of infectious disease surveillance. one translational research project focuses on validation of this novel molecular methodology for field detection assays. there is increasing awareness of the need for improved laboratory investigation, risk assessment, contingency planning and simulation exercises to respond effectively to zoonotic diseases (lipkin, ; westergaard, a and b; escorcia et al., ) . in view of the need to research into and respond to so many emerging zoonoses, it is relevant to note the fourfold classification of emerging zoonoses proposed earlier by silvio pitlik: type : from wild animals to humans (hanta); type +: from wild animals to humans, with further human-to-human transmission (aids); type : from wild animals to domestic animals to humans (avian flu); and type +: from wild animals to domestic animals to humans, with further human-to-human transmission (sars) (kahn et al., : p. ) . confronting outbreaks of these emerging zoonoses is often possible with an imaginative combination of laboratory investigation and extensive fieldwork (borchert et al., ; robinson, ) . three distinctive articles appear below on outbreak responses to zoonotic diseases, highlighting the importance of linking together basic research, practical action and an integrated one health-oriented approach. in a. grolla and nine co-authors from eight different institutions in five different countries have explained how two mobile laboratories were set up and capable of running within < h of arrival, providing safe, accurate, rapid and reliable diagnostic services as the ebola zaire outbreak began in the democratic republic of the congo. finally, in emerging and exotic zoonotic disease preparedness and response in the united states: coordination of the animal health component, dr. r. l. levings has set out the integrated approach of emergency management and diagnostics, veterinary services, animal and plant health inspection service, united states department of agriculture in the prevention of, the preparedness for, the response to and the recovery from a zoonotic disease outbreak. in all three of these areas -basic research, practical action and an integrated one health-oriented approach -much has been achieved in recent years, but much also remains to be achieved as soon as possible. even when those diseases are not transmitted to humans, there are substantive challenges, as highlighted in the next case study by woods on combating brucellosis in cattle in zimbabwe. in a practical, problem-oriented presentation, dr. p. s. a. woods (veterinary public health section, faculty of veterinary science, university of pretoria, onderstepoort, south africa and university of reading) with r. s. beardsley (pharmaceutical health services research, school of pharmacy, university of maryland, baltimore, maryland, usa) and n. m. taylor (veterinary epidemiology and economics unit, school of agriculture, policy and development, university of reading, reading, united kingdom) asked can we increase farmers' perception of their brucellosis susceptibility to improve adoption of preventive behaviors amongst small-scale dairy farmers in zimbabwe? she explained the background to the problem, presented a model that was used to develop a strategy to confront the disease and then set out the results and recommendations of the research team. brucellosis is an extremely infectious bacterium that causes abortion in cows, different syndromes in other animal species and malaria-like undulant fever, arthritis, depression and epididymitis in people. however, it had been controlled in zimbabwe until when financial constraints forced the government veterinary services to curtail disease surveillance and discontinue free vaccinations. small-scale farmers did not seek vaccination from other sources, partly because they were unaware of the necessity of vaccination, and also at that time brucellosis was absent from small-scale farming areas. however, uncontrolled cattle movements from to linked to invasions of large-scale farms resulted in dispersal of possibly brucella-positive cattle and movement of the disease into small-scale herds. the result was that brucellosis became a potential problem in these herds and now presents a serious zoonotic threat. preventing brucellosis requires movement control to stop brucella-positive cattle entering an area, as well as live vaccine for female calves. although there is no human-to-human spread of the disease, it is essential that people do not handle new-born calves or abortions from brucella-positive cows, nor drink unpasteurized milk from brucella-positive cows (arimi et al., ) . in essence, reducing the risk of brucellosis requires that farmers adopt appropriate preventive behaviours, with these control efforts and changes in behaviour being communitydirected in order to be sustainable. it was this stress upon community direction that formed the basis for funding by the wellcome trust to investigate the hypothesis that the level of a farmer's knowledge about brucellosis would influence subsequent preventive behaviour. the approach, based partly on the 'health belief model' (rosenstock et al., ) was grounded in the expectation that each small-scale farmer would make health behaviour choices according to individual perceptions about the disease and personal beliefs about their abilities and the costs required to change the risks of their cattle and families acquiring the disease. in this project, the independent variable was the level of an individual farmer's knowledge about brucellosis, while the dependent variables were two key preventive behaviours -decreasing cattle disease by calfhood vaccination and preventing zoonotic disease by milk pasteurization. the research was carried out in partnership with a national network of small-scale dairy cooperatives with all activities conducted with existing local personnel. the aim was to tailor the educational program to the initial knowledge or awareness of each community of farmers, recognizing the considerable difference in knowledge levels between-and within communities. local teams, not outsiders, developed appropriate educational materials, targeting those with the lowest levels of knowledge. completed survey questionnaires indicated a significant relationship between the initial level of farmers' knowledge about brucellosis and their calf brucellosis vaccination practices. the range of brucellosis knowledge among some small-scale farmers in southern zimbabwe was considerable, with % of farmers being unaware of the disease, % having limited knowledge and % having good knowledge. however, even amongst those farmers with a relatively high level of knowledge, % of farmers had not vaccinated their calves at the time of the survey. furthermore, there was a disappointingly low uptake of milk boiling despite a significant increase in knowledge about raw milk as a mode of infection for humans. although the information sessions did increase farmers' awareness of the dangers of zoonotic brucellosis, an exaggerated perception of the effectiveness of calf vaccination decreased the likelihood of safe milk practices. this outcome indicated the importance of reaching the women who were responsible for milk and food preparation. ongoing research is investigating whether increasing the role of nurses and environmental health technicians to emphasize human infection and to reach different family members, within a research paradigm which combined veterinary and human medicine, would increase the uptake of milk hygiene practices. there is increasing awareness of the need to balance transparency with carefully designed information disclosure strategies in the face of sudden outbreaks of foodborne diseases (national research council, ; taylor, ) . both consumers and producers must be rapidly informed of any significant dangers with specific food products; however, considerable misinformation can be spread if laboratory results are incomplete or inconclusive (palm et al., ) . recent experience with e. coli-infected sprouts in germany and listeria-infected cantaloupes the united states has highlighted the difficulties in identifying the original source of a disease outbreak, as well as the swiftness with which an unexpected food-borne disease can cause sickness and death (armour, ; blaser, ; buchholz et al., ; frank et al., ) . it should be noted that that there was no easily identified zoonotic link in either of these two food-borne diseases derived from bacteria, which killed people in the united states and throughout europe during ; however, as professor c. kastner points out later, a significant number of these food-borne diseases do have a zoonotic origin (parker et al., ) . two articles linked to this topic are published in this special supplement. first, there is emerging antimicrobial resistance in commensal e. coli with public health relevance by dr. a. käsbohrer and her colleagues. their aim was to assess the prevalence of and trends in antimicrobial resistance through active monitoring programs along the food production chains for poultry, pigs and cattle, as well as to collect isolates for resistance testing and then select certain isolates for further phenotypic and genotypic characterization. the research team found alarming rates of resistance to antimicrobials in zoonotic bacteria and commensals, as set out in their article, which could compromise the effective treatment for human infections. this work provides a basis on which to improve both risk assessment and risk mitigation strategies in the face of the increasing antimicrobial resistance to zoonotic bacteria and parasitic organisms within both humans and animals. second, in american trypanosomiasis infection in fattening pigs from the south-east of mexico, m. jiménz-coello and her colleagues have investigated the extent to which the protozoa trypanosoma cruzi (t. cruzi) is presenting in fattening pigs in yucatan, mexico, threatening parasitic infections in animals destined for human consumption. tackling the question of how to refine national and international strategies to combat food-borne zoonotic diseases, professor c. kastner (food science institute, kansas state university, manhattan, kansas, usa) considered the public health and economic impact of foodborne zoonotic diseases. he began by noting that each year in the united states, according to statistics from the centers for disease control, million people become sick from food-borne diseases, , are hospitalized and , die. a significant portion of these diseases have a zoonotic origin, with extensive product recalls and domestic as well as international trade disruptions (fung et al., ) . therefore, more than years ago, the us department of agriculture established a food safety consortium ( ) which focuses on food-borne zoonotic diseases involving beef in kansas, pork in iowa and poultry in arkansas. the continuing aim of that consortium is to develop long-term control strategies that identify the critical control points and control technologies, as well as short-term strategies to address incidental contamination, whether accidental or intentional. the us livestock industry in general and kansas in particular are vulnerable to food-borne zoonotic diseases. for example, in kansas, sources of contamination include feed, feedlots (which vary in size from , to , head per lot) and packing plants (which vary in size from , to more than , head per day per plant). beef processing points where mixing of different ingredients occurs are the most critical points for both incidental and intentional contamination. in the light of these challenges, a biosafety level research facility, the biosecurity research institute (bri) ( ) has been built on the kansas state university campus, to evaluate strategies to detect and control food-borne zoonotic diseases from production through processing. furthermore, in minneapolis, minnesota, ncfpd (national center for food production defense, ) has been operational since as a department of homeland security center of excellence. ncfpd has adopted a systems approach whose goals include to: (i) ensure significant improvements in supply chain security, preparedness and resiliency; (ii) develop rapid and accurate methods to detect incidents of contamination and to identify the specific agent(s) involved; (iii) apply strategies to reduce the risk of food-borne illness because of intentional contamination in the food supply chain and to develop the tools to facilitate recovery from contamination incidents; (iv) deliver appropriate and credible risk communication messages to the public; and (v) develop and deliver highquality education and training programs to develop a cadre of professionals equipped to deal with future threats to the food system. these research centers are essential to minimize the threat of food-borne zoonotic diseases. t. cutts (national microbiology laboratory, public health agency of canada, canadian science centre for human and animal health, winnipeg, manitoba, canada) presented comparative inactivation studies of listeria monocytogenes at room and refrigeration temperatures on behalf of a research team that included b. carruthers, c.-l. cross, s. theriault (chief, applied biosafety research program, same center) and himself. listeria monocytogenes, a non-sporulating, gram-positive bacillus, is found chiefly in ruminants, but can affect all species and causes listeriosis, an infrequent but serious illness that affects the central nervous system of humans and domestic animals (bortolussi, ; chan and weidmann, ). listeriosis can be acquired from the consumption of contaminated foods and has an incubation period ranging from to days (bortolussi, ; chan and weidmann, ). because of this variable incubation period and the fact that listeriosis leads to a mortality rate of - %, the applied biosafety research program at the national microbiology laboratory of the public health agency of canada considered the significance of proper decontamination of listeria in food processing environments (chan and weidmann, ). the importance of this work is indicated by the fact that somewhere from to % of ready-to-eat foods are thought to be contaminated with listeria (public health agency of canada, and . recently, listeria monocytogenes has gained notoriety because of its ability to grow at the low temperatures, high salt and low ph used in food processing plants (bortolussi, ) . therefore, a study was undertaken to determine the bactericidal efficacy of various liquid disinfectants and the effect that low temperatures have on the ability of these disinfectants to inactivate l. monocytogenes at conditions found in food processing plants. at both room and refrigeration temperature ( °), ethanol, javex, su and peracetic acid (paa) products outperformed all others. surprisingly, there was no significant variation in performance at room temperature compared with refrigeration temperature. however, as some organisms undergo changes during a temperature shift, it is crucial to test each disinfectant at the temperature at which it will be employed. bleach was found to be effective but is toxic, corrosive and residue forming, while the paa and ethanol compounds do not form residues and are not corrosive. as a result of these studies, major canadian food-processing plants have changed their decontamination procedures and are no longer using quaternary ammonium compounds (quats), which were previously used extensively. positive relations have been built up between companies and laboratories, leading to more relevant laboratory studies and industrial applications (public health agency of canada, ). a prion (proteinaceous infectious particle) has been defined as a 'malformed version of a normal cellular protein that apparently ''replicates'' by recruiting normal proteins to adopt its form, [thus becoming] capable of infecting other cells of the same, or a different organism' (prusiner, ; thain and hickman, , p. ) . although two nobel prizes in medicine have been awarded for prion research, to carleton gajusek in and to stanley prusiner in , the precise nature of the infectious agent remains unclear to such an extent that controversy continues about whether a prion is solely protein (brooks, , pp. - ) . whatever the cause, prion diseases are fatal chronic neurological diseases that affect the brains and nervous systems of many mammals, including humans (imran and mahmood, ) . prions can be detected in tissues by a number of research techniques, including infective bioassay, animal inoculation, western blot and immunochemistry. it is clear that prions can cause spongiform encephalopathies within both humans and animals (e.g. creutzfeldt-jakob disease, kuru, scrapie, transmissible mink encephalopathy, feline spongiform encephalopathy and bovine spongiform encephalopathy) (blood et al., (blood et al., , p. . summaries of the three presentations below offer further insights into the nature of prion diseases. in prion diseases, professor j. j. badiola and dr. c. akin (university of zaragoza, zaragoza, spain) focused on the outbreak of bovine spongiform encephalopathy (bse) ('mad cow disease') in the united kingdom, which led to a better understanding of the epidemiology and molecular characteristics of the disease. epidemic bse affected mainly the united kingdom, with a total of , positive animals compared to , in all other member states of the european union (oie, ). control and eradication of transmissible spongiform encephalopathies (tses) became a priority, not only in europe, but throughout the world. in , a reinforcement of the passive surveillance program and the establishment of an active one were established by the european commission for all the european union member states (european commission, ) . passive surveillance, focused on animals with clinical signs of the disease, and active surveillance was carried out in the following target groups: healthy slaughtered, fallen stock, emergency slaughtered and animals culled under bse eradication. apart from these measures, specific risk materials (e.g. tonsils, intestines, spleen, spinal cord and skull, including the brain and eyes) were defined and prohibited from being included in the human food chain. moreover, a banning of all meat and bone meal for animal feed was established (european commission, ) . the result of these powerful eradication measures has been a rapidly decreasing number of new bse cases, with less than cases detected worldwide in , of which were in the european union (oie, ) . the impressive containment of bse in the united kingdom from , reported cases in to in is testimony to the determination with which scientists, politicians, civil servants and farmers have worked together to bring the disease under control. professor c. i. lasmézas (dept of infectology, the scripps research institute, scripps, florida, usa) began her presentation, zoonotic potential of new animal prion diseases: assessment in non-human primates, by noting that the first demonstration of the transmissibility of a prion disease to non-human primates (nhps) was made in by carleton gajdusek when he transmitted kuru to chimpanzees. since then, animal and human prion diseases have been transmitted to a range of nhps. cynomolgus macaques have shown the highest selectivity with regard to the prion strain by which they can be infected and therefore seem to be the species of choice to assess the risk that any given animal prion strain can be pathogenic for humans (lasmézas et al., ) . prions were thought to be very difficult to transmit from one species to another; however, the experience of studying scrapie highlights the difficulties inherent in studying prion diseases in the laboratory. scrapie had been transmitted orally to other ruminants (goats) but only intracerebral inoculations had successfully transmitted scrapie to monkey, mouse or mink. however, the oral transmission of bovine spongiform encephalopathy (bse) to domestic cats in forced a revision of this earlier belief. transmissions of bse have now occurred orally to sheep, goat, monkey, mink, cheetah, puma, cat and mouse. intracerebral transmission of bse has also occurred to pig. furthermore, intraspecies oral transmission of bse has taken place within numerous speciesmonkey, mink, sheep, goat, cow, hamster and mouse. vcjd (variant creutzfeldt-jakob disease) is a new human disease, which was caused by eating ruminant-derived food products contaminated with bse. vcjd poses a public health problem because of the absence of preclinical diagnostic test, the long incubation periods of prion diseases in humans (possibly extending up to years) and the transmissibility of the disease by blood transfusion. the research team at the french commissariat a l' energie atomique (cea) demonstrated that bovine spongiform encephalopathy (bse) was transmissible to macaques within years with a % infection rate and caused a disease indistinguishable from the human variant of creutzfeldt-jakob disease (lasmézas et al., ) . this provided a model to study carefully the peripheral pathogenesis of vcjd, the oral infectious dose of bse and evaluate the risk of human-to-human transmission of vcjd by blood transfusion (herzog et al., ) . further, the research team used the macaque model to assess the zoonotic potential of emerging forms of bse called l-or h-type. the l-type bse presents with higher pathogenicity to macaques than classical bse (comoy et al., ) . therefore, continued precautionary measures remain necessary to protect the human food chain. experiments are ongoing at the national institute of allergy and infectious disease, hamilton, montana, to assess the risk linked to chronic wasting disease that is spreading throughout the usa. the closing acknowledgements of professor lasmézas to other researchers indicated both the complexity and importance of continuing work in prion diseases. furthermore, since the cancun meeting further important research has been published (hamir et al., ) . infectivity distribution studies of animals infected with bse prions animals are a matter of considerable importance in seeking to elucidate the route of infectious prions from the gut to the central nervous system (cns) open questions about this lethal journey from the gut to the brain, including where in the gut the disease begins, the initial steps of the neuronal bse pathogenesis, the ascension of bse prions to the brain, the haematogenous spread and the centrifugal contamination of the periphery (buschmann and groschup, ; hoffmann et al., ) . the scale of the research task was indicated by the fact that , samples were collected per animal autopsy, leading to some , frozen samples collected and archived at the friedrich-loeffler-institut. tissue samples were collected from the gut, the central and autonomous nervous system (ans) of the challenged bovines and then examined for the presence of pathological prion proteins (prp sc ). there was some variation among different animals. however, a distinct accumulation of prp sc was observed in the distal ileum, confined to follicles and/or the enteric nervous system, in almost all animals . bse prions were found in the sympathetic nervous system starting from months post-inoculation (mpi) on as well as in the parasympathetic nervous system from mpi on (kaatz et al., ) . a clear dissociation of prion infectivity and detectable prp sc deposition was obvious in tongue (balkema- . the earliest presence of infectivity in the brainstem was detected at mpi, while prp sc -accumulation was detected first after mpi. in summary, these results deciphered for the first time the centripetal spread of bse prions along the ans to the cns starting already half way during the incubation period. bse prions spread in cattle from the gut to the brain along the sympathetic, parasympathetic and spinal cord routes, possibly in that order of importance. spinal cord involvement may even not be necessary at all, but bse infectivity in the form of prp sc spills over into the periphery already in the pre-clinical phase. the modelling and prediction of emerging zoonoses is a fast-growing field of considerable complexity. of the five papers relevant to this topic, two have been published in full below in this special supplement. dr. g. zanella and her colleagues consider modelling transmission of bovine tuberculosis in red deer and wild boar in normandy, france. their mathematical model of the mycobacterium bovis infection within and between species takes into account the transmission of m. bovis through infected offal -the viscera of animals killed by hunters and left behind. when an animal was hunted in the brotonne forest in normandy prior to , it was eviscerated in situ and only the carcass taken away, with the raw viscera left behind. since , offal disposal has been required in brotonne forest; however, the regulation has not always been observed by hunters (unpublished correspondence with g. zanella, - december, ) an important benefit of mathematical modelling is that it permits consideration of all the elements involved in disease transmission within a population, thereby complementing field data, as well as testing the effects of control measures. thus, the direct transmission of the m. bovis infection within the red deer and wild boar populations can be distinguished from indirect transmission through contaminated offal. the model indicates that offal destruction is the key factor in infection control for both red deer and wild boar. the authors conclude that, in principle, the structure of this model is relevant to the situations where dead animals play an important role in disease transmission between two or more species. in a further article published in this special supplement, constructing ecological networks: a tool to infer risk of transmission and dispersal of leishmaniasis, dr. c. gonzález-salazar and professor c. stephens set out the role of ecological networks as a powerful tool for understanding and visualizing inter-species ecological and evolutionary interactions. taking the example of leishmaniasis in mexico, they show that such networks can be used not only to understand potential ecological interactions between species involved in the transmission of the disease, but also to identify the potential role of the environment in disease transmission and dispersal. strikingly, they show how potential interactions can be inferred from geographical data, rather than by direct observation. their findings have led to the prediction of additional reservoirs in mexico of many new species, including bats and squirrels. the resulting model can be used to understand and map potential transmission risk, as well as construct risk scenarios for the dispersal of leishmaniasis from one geographical region to another. such a risk assessment tool for leishmaniasis will be especially useful in the light of the bill and melinda gates foundation decision in january to join with major pharmaceutical companies and the world health organization in targeting leishmaniasis as one of the neglected tropical diseases to receive improved drugs, diagnostics, vector control strategies and vaccines (bill & melinda gates foundation, ; boseley, ) . however, the possibility of new reservoirs suggests it is hard to imagine that leishmaniasis can be completely eradicated. nevertheless, it is increasingly clear that leishmaniasis has a disturbing capacity to jump from species to species, so efforts to control the disease must be given a high priority (unpublished correspondence with c. stephens, february , ; cf. flanagan et al., ) . it is difficult to model and predict the distribution and impact of a new emerging virus. for example, the emergence in november in europe of a midge-borne virus member of the bunyaviridae family, named schmallenberg virus after the location in germany where it was first detected, has caused serious birth defects in lambs, goats and cattle (ecdc, ) . scientists, farmers, veterinarians, public health officials and consumers are all confronted with the uncertainty inherent in facing a new animal pathogen (farmers weekly, ) . appropriately, at the same time as this new virus has emerged, the animal health and veterinary laboratories agency (ahvla) has set up a new independent advisory group to evaluate veterinary surveillance in england and wales, although their original intent was in part to consider funding reductions (trickett, ) . modelling risk factors for zoonotic influenza infections is challenging because the infections are often rare; the laboratory assays are often difficult and imprecise, and the most definitive studies require intensive resources. this was the view of professor g. c. gray (emerging pathogens institute and college of public health and health professions, university of florida, gainesville, florida, usa) in his presentation, modeling risk factors for zoonotic influenza infections in man: challenges and strategies for success. in particular, serologic detections of these infections in humans may be confounded by crossreacting antibody, waning antibody from the infection of interest, inaccurate matching of the enzootic pathogen and the laboratory strain, laboratory errors and weakly powered statistical comparisons. the underlying question which professor gray and his research team is tackling is: which human, animal and environmental factors predict disease? these three factors can be viewed as a venn diagram with its intricate interactions. like understanding cardiovascular disease, how a person acquires a zoonotic influenza infection is a complex process, and predictive laboratory assays are imprecise. for example, with avian influenza viruses (especially h n , popularly known as 'bird flu'), poultry veterinarians, turkey workers, hunters and people without indoor plumbing may be at increased risk of aiv infection but infections are rare. subclinical or mild infections do occur; and occasionally aiv causes severe disease in persons exposed to sick birds. although aiv transmission from human-to-human seems rare, further cohort studies and more sensitive serological assays are needed. a basic scientist often tests hypotheses by: (i) carefully setting up an experimental setting; (ii) isolating confounding factors; and (iii) looking for statistically significant associations with an outcome. such a process is not possible for a number of emerging disease problems such as human infections with swine influenza virus (siv). experimental studies are not possible. hence, epidemiologists must perform observational studies of people most likely to be infected with siv and by looking at possible risk factor associations, infer causality. one must first determine settings where the prevalence of siv in expected to be high and then study those workers. for example, sivs are often endemic in large-scale modern production facilities. risk factors for sow-herd siv seropositivity involve pig density, whether there is an external source of breeding pigs, the total animals on the site and the closeness of barns. similarly, risks factors for finisherherd siv positivity must be considered -the number of siv-positive sows, size of herd, pig farm density and farrow-to-finish type of farm (poljak et al., ) . however, siv surveillance in pigs is largely passive and voluntary, so recognizing which pig workers to study is a challenge. detection of siv infections in man often requires a sentinel event (e.g. human illness with pig exposure or sick pigs). as pigs do not always have clinical signs of novel virus infection and often there is no compensation system to protect pig farmers, the pork industry is reluctant to permit the study of their workers for siv infection (gray and baker, ) . therefore, these observational studies are currently very difficult. professor gray concluded by pointing out that although there are numerous challenges in conducting epidemiological studies for zoonotic influenza, there are six substantive ways to control confounding variables: (i) design every study carefully; (ii) use non-animal-exposed controls; (iii) employ validated laboratory assay using zoonotic influenza strains; (iv) use multivariate modeling to examine cross-reacting serologic responses due to human viruses and vaccines; (v) consider proportional odds modeling; and (vi) consider employing a second unique serologic test (see gpl, ) . with the support of co-authors from different institutions, dr. k. j. linthicum (united states department of agriculture, agricultural research service, center for medical, agricultural & veterinary entomology, gainesville, fl, usa) presented two case studies about forecasting emerging vector-borne diseases. dr. linthicum began by pointing out that global climate variability, often linked to el niño conditions, can be used to forecast emerging vector-borne disease spread in local areas (linthicum et al., ) . these forecasts are possible because specific pathogens, their vectors and hosts are sensitive to temperature, moisture and other ambient environmental conditions. with consistent and reliable satellite observations, global sea temperatures, climate and vegetation can be observed. first, temperature plays a major role in its impact on aides aegypti mosquitoes transmitting dengue haemorrhagic fever virus in southeast asia (linthicum et al., ) and possibly also on how ae. aegypti transmits chikungunya virus in africa and asia , as well as on how anopheles species mosquitoes transmit p. vivax malaria in the republic of korea. vectorial competence is dependent upon the extrinsic incubation (ei) period in the mosquito vector. the ei represents the time from ingestion of the virus while feeding on a viremic host to the virus arriving in the salivary glands. the shorter the ei period, which occurs during higher ambient temperatures, the greater the vectorial competence (garrett- jones and shidrawi, ) . if data are available for a specific local area on the daily humanbiting rate (ha) of the mosquitoes, the daily rate of blood feeding (a) and the length of the ei cycle (n), it is possible to calculate vectorial capacity (rattanarithikul et al., ) . second, accurate measurements and understanding of how exceptionally heavy rainfall and flooding affects aides and culex mosquitoes and the introduction of virusinfected mosquitoes into susceptible vertebrate hosts enables forecasts to be made about when and where rift valley fever (rvf) will develop in sub-saharan africa and middle east (anyamba et al., ) . outbreaks of rift valley fever are known to follow periods of widespread and heavy rainfall associated with the development of a strong inter-tropical convergence zone over eastern africa (davies et al., ) . during periods of elevated transmission, there is a significantly increased risk of globalization of these and other arboviruses; however, the forecasting methods described provide . - months early warning before an outbreak and provide ample time for disease mitigation before the first cases appear (anyamba et al., ) . furthermore, the emergence and expansion of a number of disease vectors (e.g. mosquitoes, mice, locust) often follow the trajectory of the green flush of vegetation in semiarid lands. the ability to predict periods of elevated risk enables better prevention, containment or exclusion strategies to be drawn up to limit globalization of emerging pathogens. thus, it has been possible for the food & agricultural organization (fao) to create a system of alerts -the emergency prevention system for transboundary animal and plant pests and diseases (empress, ) . subsequent to dr lithicum's presentation, significant further work has been done to provide a genome-scale overview of gene expression in the malaria-transmitting mosquito anopheles gambiae (maccallum et al., ) , as well as to expand the vectorbase website with regularly updated genome information on two other mosquito species, aedes aegypti and culex quinquefasciatus, and numerous other organisms, including the tick species ixodes scapularis (lawson et al., ; niaid, ) . the ultimate aim of this research is to create a database that will facilitate a systems-level view of gene expression for many different organisms. reflecting on the numerous types of statistical analysis that are used to estimate confidence intervals for proportions in scientific studies, dr. s. guillossou and his colleagues professors h. m. scott and j. a. richt (dept. of diagnostic medicine and pathobiology, college of veterinary medicine, kansas state university, manhattan, kansas, usa) utilized the final presentation of the conference, estimates of low prevalences and diagnostic test estimates: what confidence do we really have? to illustrate the differences, limits and sometimes chaotic behaviour of different statistical approaches. dr. guillossou pointed out that there were more than different methods for determining a % confidence interval of a proportion. he stressed that it is always important to report the method of statistical analysis being utilized. in his view, the agresti-coull interval approach presents a satisfactory compromise between computational requirements and coverage probability (newcombe, ; brown et al., ) . ideally, the effects of coverage probability should be estimated and the most appropriate method chosen before reporting the findings or using proportions as inputs in any epidemiological study. what did this th international conference on emerging zoonoses achieve? there was the opportunity to meet old friends and make new friends, to share one's academic work and to reflect on what lies ahead with emerging zoonoses. it is now clear that human medicine, veterinary medicine and environmental challenges are a unity which must be considered under the umbrella of 'one health' (one health initiative, ) . viruses are continuing to jump from animals to people with unexpected consequences, because the evolution of any virus is impossible to predict. even the recent relatively mild swine flu virus infected % of the human population and killed some , people globally -far less than would have been the case if the virus had mutated to a more deadly form, as might easily have happened. the reality is, as professor nathan wolfe, professor in human biology at stanford university, has commented: 'as a species, we're not that focused on the things that have the most potential to be devastating to us as a global population, such as viruses. unless people take these things seriously, we're going to look back and say we had all the tools necessary to try to address these risks, and we basically ignored them because they weren't dramatic like a car accident or a hurricane' (geddes, ; kahn, ; wolfe, ) . this conference, many others and the th international conference on emerging zoonoses to be held in in berlin, are aimed at creating, improving and using the tools essential to address the risks of viral contagions in a global society. none. the organizing committee of the conference wishes to acknowledge the excellent services of the conference organizers, target conferences of tel aviv, israel, and the welcome financial contributions of medimmune, boehringer ingelheim vetmedica gmbh, prionics ag, center of excellence for emerging and zoonotic animal diseases (ceezad) and national center for foreign animal and zoonotic disease defense (fazd), as well as the poster prize donated by wiley-blackwell. we are also grateful to the wiley-blackwell staff who have contributed so significantly to this special supplement, especially rachel robinson and peter tubman, as well as to dr. klaus osterrieder for his helpful comments and to the presenters who have approved or improved every summary in this meeting review. this material is based upon work supported by the u.s. department of homeland security under grant award number -st-ag . the views and conclusions contained in this supplement are those of the authors and should not be interpreted as necessarily representing the official policies, either expressed or implied, of the u.s. department of homeland security. additional funding has been provided by the kansas bioscience authority. conservation medicine: ecological health in practice prediction of a rift valley fever outbreak : prediction, assessment of the rift valley fever activity in east and southern africa - and possible vector control strategies climate teleconnections and recent patterns of human and animal disease outbreaks risk of infection with brucella abortus and escherichia coli o :h associated with marketing of unpasteurized milk in kenya fallout from listeria outbreak hits walmart: retail detection and identification of mycoplasma from bovine mastitis infections using a nested polymerase chain 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clinical aspects of human infection with avian influenza a (h n ) virus modification of non-structural protein of influenza a virus by sum key: cord- -nik xizn authors: aitsi-selmi, amina; murray, virginia; heymann, david; mccloskey, brian; azhar, esam i.; petersen, eskild; zumla, alimuddin; dar, osman title: reducing risks to health and wellbeing at mass gatherings: the role of the sendai framework for disaster risk reduction date: - - journal: int j infect dis doi: . /j.ijid. . . sha: doc_id: cord_uid: nik xizn mass gatherings of people at religious pilgrimages and sporting events are linked to numerous health hazards, including the transmission of infectious diseases, physical injuries, and an impact on local and global health systems and services. as with other forms of disaster, mass gathering-related disasters are the product of the management of different hazards, levels of exposure, and vulnerability of the population and environment, and require comprehensive risk management that looks beyond single hazards and response. incorporating an all-hazard, prevention-driven, evidence-based approach that is multisectoral and multidisciplinary is strongly advocated by the sendai framework for disaster risk reduction – . this paper reviews some of the broader impacts of mass gatherings, the opportunity for concerted action across policy sectors and scientific disciplines offered by the year (including through the sendai framework), and the elements of a (st) century approach to mass gatherings. mass gatherings of people at religious pilgrimages and sporting events are linked to numerous health hazards and accidents. [ ] [ ] [ ] [ ] traditionally, attention from public health authorities has focused on the transmission of infectious diseases, their impact on local health systems and services, and the threat to global health security of those with epidemic potential. [ ] [ ] [ ] the world health organization (who) defines a mass gathering as ''an organized or unplanned event where the number of people attending is sufficient to strain the planning and response resources of the community, state or nation hosting the event''. events at religious pilgrimage sites, sports facilities, air shows, musical festivals, political rallies, and other events that attract crowds vary in their complexity and demand for medical services and can lead to losses in lives, livelihoods, and health in the event of failure to cope with health hazards in emergency situations. one of the largest regular mass gatherings in the world is the hajj. it is the annual mass gathering of over two million muslims from all over the world and presents challenges to the authorities in saudi arabia. , the inevitable overcrowding in a confined area of such large numbers increases the risk of injuries, heat exposure, and a range of infectious diseases. the risk of infection was evident in the outbreaks of meningococcal w strains in and with their associated high mortality and potential for international spread. indeed, the annual hajj has faced several disasters due to fires at camp sites and in crowded tunnels, falling cranes, and stampedes due to failures in crowd movement control. however, as in a number of other health policy areas, reducing the health risks of mass gatherings and seizing the opportunities for health improvement that mass gatherings may offer requires a broader approach to the underlying determinants of risk. a comprehensive risk approach incorporates a wide range of hazards as well as taking into account the role of population vulnerability and exposure levels. , , such an approach is akin to the social determinants of health approach, which looks at the upstream factors behind health outcomes, including socioeconomic inequalities. the positive implication of this more comprehensive approach is that mass gatherings, as with other forms of hazard, can be seen as amenable to prevention, and new avenues of policy and management to reduce the risk to people and their environment open up. there is global agreement that disasters are not natural events and that disaster risk arises as the result of the interaction between hazards (natural hazards such as earthquakes or human-made hazards such as anthropogenic climate change) and predisposing vulnerabilities and exposures. disaster risk reduction (drr) encompasses the scientific, policy, and practice activities that aim to reduce losses in lives, livelihoods, and health by acting on hazard probability, vulnerability, and exposure levels. as alluded to above with the hajj example, the health consequences of mass gathering-related disasters are many and go beyond the transmission of travel-related infectious disease (middle east respiratory syndrome coronavirus (mers-cov), severe acute respiratory syndrome (sars), etc.). they include injuries resulting from crowd density and inadequate infrastructure (e.g., bridge collapse), exposure to extreme weather events, and escalation of violence as a result of crowd behaviour. risks can be compounded, for example, when population displacement and overcrowding in evacuation or re-housing facilities leads to a further increase in the risk of infectious disease outbreaks, or overwhelmed medical services are unable to deliver on elective functions such as chronic disease management, putting those who need life-saving medication such as insulin for diabetes in a particularly vulnerable position. , furthermore, the mental health consequences of traumatic incidents such as disasters, in general, can be prolonged, with stress to people, families, and communities resulting in short-term fear of death, as well as general distress, anxiety, excessive alcohol consumption, and other psychiatric disorders. in other words, mass gatherings, if improperly managed, can result in what has been defined by the united nations international strategy for disaster reduction (unisdr) as ''a serious disruption of the functioning of a community or a society involving widespread human, material, economic or environmental losses and impacts, which exceeds the ability of the affected community or society to cope using its own resources'' -the unisdr's definition of a disaster. the sendai framework for disaster risk reduction - is the first of three united nations landmark agreements agreed in (the other two being the sustainable development goals (https://sustainabledevelopment.un.org/) agreed in september , and the un framework convention on climate change adopted in december (http://unfccc.int/ .php)). the sendai framework is a voluntary agreement adopted on march , by united nations member states after extensive negotiations at the world conference on disaster risk reduction, the successor to the hyogo framework for action . it has a greater emphasis on health and gives a clearer mandate emphasizing the need for more integrated drr that incorporates bottom-up as well as top-down approaches, local scientific and technical knowledge, and draws attention to synergies with other critical policy arenas, including health, climate change, and sustainable development. the sendai framework captures the developments in science and policy thinking of the last - years in moving beyond a single hazard and a response-focused approach to disasters, to an all-hazard, preventive, multisector and multidisciplinary approach that links with sustainable economic development and climate change. the sendai framework outcome for the next years is to achieve ''the substantial reduction of disaster risk and losses in lives, livelihoods and health and in the economic, physical, social, cultural and environmental assets of persons, businesses, communities and countries''. the following actions with a public health focus are agreed in the sendai framework with local, national, regional, and global partners as relevant: ''enhancing the resilience of national health systems through training and capacity development; strengthening the design and implementation of inclusive policies and social safety-net mechanisms, including access to basic health care services towards the eradication of poverty; finding durable solutions in the post-disaster phase to empower and assist people disproportionately affected by disasters, including those with life-threatening and chronic disease; enhancing cooperation between health authorities and other relevant stakeholders to strengthen country capacity for disaster risk management for health; the implementation of the international health regulations ( ) and the building of resilient health systems; improving the resilience of new and existing critical infrastructure, including hospitals, to ensure that they remain safe, effective and operational during and after disasters, to provide live-saving and essential services; establishing a mechanism of case registry and a database of mortality caused by disaster to improve the prevention of morbidity and mortality and enhancing recovery schemes to provide psychosocial support and mental health services for all people in need''. the sendai framework also recognizes the challenges and gaps: ''enhanced work to reduce exposure and vulnerability, thus preventing the creation of new disaster risks, and accountability for disaster risk creation are needed at all levels. more dedicated action needs to be focused on tackling underlying disaster risk drivers, such as the consequences of poverty and inequality, climate change and variability, unplanned and rapid urbanization, poor land management and compounding factors such as demographic change''. the sendai framework has a strong emphasis on the importance of science as a robust foundation for informing decisionmaking and underpinning drr. specific recommendations for the scientific community to improve the understanding of risk and how to achieve its expected outcome of reducing disaster losses in lives, livelihoods, and health include: ''enhanced scientific and technical work on disaster risk reduction and its mobilization through the coordination of existing networks and scientific research institutions at all levels and all regions, with the support of the united nations international strategy for disaster reduction's scientific and technical advisory group, in order to strengthen the evidence base in support of the implementation of this framework; promote scientific research of disaster risk patterns, causes and effects; disseminate risk information with the best use of geospatial information technology; provide guidance on methodologies and standards for risk assessments, disaster risk modelling and the use of data; identify research and technology gaps and set recommendations for research priority areas in disaster risk reduction; promote and support the availability and application of science and technology to decision-making; contribute to the update of the terminology on disaster risk reduction; use post-disaster reviews as opportunities to enhance learning and public policy and disseminate studies''. the sendai framework, when implemented, has the potential to be a truly relevant framework for health, advocating for an allhazards approach. it makes more than explicit references to health, highlighting the importance of outbreaks and epidemics, chronic disease management, psychosocial interventions, rehabilitation as part of disaster recovery, and makes several references to the international health regulations. reducing losses in lives, livelihoods, and health: building on synergies between disaster risk reduction and health to reduce risks from mass gatherings the battle against the spread of travel-related infections and other risks facilitated by globalization that arise from mass gatherings is a shared responsibility between different countries, sectors, and disciplines that can help to reduce risk. the coordination of preventive measures by health services, emergency services, engineers, scientists, the private sector, governments, and civil society requires the adoption of an all-hazard approach that is multidisciplinary and multisectoral. the benefits from such measures go beyond those directly involved in any particular mass gathering to protect health and reduce vulnerability globally. the expansion of drr from a (single) hazard response-focused approach to a risk-based approach addressing vulnerability and exposure alongside hazard probability has been compared to the widening of the scope of health activities beyond clinical interventions on diseases to health system strengthening and prevention. public health is increasingly concerned with the latter and works across policy sectors that have an impact on health and wellbeing, such as economic, agricultural, and educational policy. an important driver is the realization that the costs of reactive health interventions dealing with illness in hospitals are exceeding societal resources, alongside concerns for fairness and equity. given the health imperative for drr over the - period, as promoted in the sendai framework, a much stronger focus on improving the health outcomes for people at risk of emergencies is needed. through participation in the sendai framework policy process, health actors and their partners such as the unisdr have worked to ensure that people's health is considered as an explicit outcome of the sendai framework and that health outcomes are seen as a shared responsibility among all actors in drr and emergency risk management. , member states of the who made high-level policy commitments to drr and adopted a resolution at the world health assembly to strengthen national health emergency and disaster management capacities and the resilience of health systems. looking to the future, member states and the who secretariat have set a course that brings together drr and emergency response. commitments include the provision of greater input and participation by the health sector in drr national, regional, and global fora. the who promotes an all-hazard approach and an integrated multisectoral response to emergencies. the who global pandemic influenza preparedness framework (http://www. who.int/influenza/resources/pip_framework/en/) has already embraced the principles of this integrated all-hazard approach. a conceptual diagram for the integration of the who emergency and disaster risk management for health (edrm-h) framework into broader national drr strategies has been proposed (see figure ), , and could potentially be used to guide the risk management of large mass gathering events. following the adoption of the sendai framework, the who has committed to building on previous efforts and is currently developing guidance (''reducing health consequences of emergencies and disasters: a risk management policy guide'') to help countries to effectively manage emergency risks and reduce their health consequences. mass gatherings can introduce new and challenging risks that need to be managed and need to be understood better. priority of the sendai framework calls for the drr community and its partners: ''[t]o develop and strengthen, as appropriate, coordinated regional approaches and operational mechanisms to prepare for and ensure rapid and effective disaster response in situations that exceed national coping capacities''. the health sector has clearly recognized the link between mass gatherings and preparedness to reduce disaster risk, but the translation of global policy into local and national capacity remains to be achieved. the sendai framework offers an opportunity to galvanize member states and local authorities to achieve common goals by offering a clearer vision and narrative for concerted action and funding reform. the sendai framework offers a unique opportunity to move beyond simply responding to emergencies to a more comprehensive, prevention-based approach to mass gathering management through the use of science and technical capabilities. it puts the protection of people's health, lives, and livelihoods at its centre. of note, the sendai framework promotes the strengthening of the science-policy interface and the development of links to other large global instruments (sustainable development goals, climate change, and the international health regulations). in summary, globalization has created interdependencies that render local disaster impacts in distant locations relevant to communities everywhere, such that risk is shared across national and institutional boundaries. therefore, reducing risk is a shared responsibility particularly where events or mass gatherings are enhanced by the advantages of globalization in terms of travel, interconnectivity of services, and supply chains. for an evidencebased approach to the health impacts (including infectious disease control) of mass gatherings to be effective, it will be important to blend all-hazard risk management strategies across current global initiatives. in practice, for countries, this will mean harmonizing national strategies across intergovernmental agreements, including the sendai framework, the international health regulations, the sustainable development goals, and the un framework convention on climate change, to optimize resource investment. conflict of interest: the authors declare that they have no conflicts of interest. report: science is used for disaster risk reduction hajj: infectious disease surveillance and control olympic and paralympic games: public health surveillance and epidemiology european football championship finals: planning for a health legacy global perspectives for prevention of infectious diseases associated with mass gatherings emerging infectious diseases and pandemic potential: status quo and reducing risk of global spread federal emergency management agency thailand's flooding: its impact 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framework for disaster risk reduction the sendai framework for disaster risk reduction: renewing the global commitment to people's resilience, health, and well-being from knowledge to action: bridging gaps in disaster risk reduction world health organization. statement made at the global platform for disaster risk reduction world health organization. who statement to the th session of the global platform for disaster risk reduction strengthening national health emergency and disaster management capacities and resilience of health systems who's interdepartmental mass gatherings group best practice protecting people's health from the risks of disasters integrating health into disaster risk reduction strategies: key considerations for success world health organization the impacts of natural disasters on global supply chains key: cord- -b mzk p authors: pandit, nitin; vanak, abi t. title: artificial intelligence and one health: knowledge bases for causal modeling date: - - journal: j indian inst sci doi: . /s - - - sha: doc_id: cord_uid: b mzk p scientists all over the world are moving toward building database systems based on the one health concept to prevent and manage outbreaks of zoonotic diseases. an appreciation of the process of discovery with incomplete information and a recognition of the role of observations gathered painstakingly by scientists in the field shows that simple databases will not be sufficient to build causal models of the complex relationships between human health and ecosystems. rather, it is important also to build knowledge bases which complement databases using non-monotonic logic based artificial intelligence techniques, so that causal models can be improved as new, and sometimes contradictory, information is found from field studies. abstract | scientists all over the world are moving toward building database systems based on the one health concept to prevent and manage outbreaks of zoonotic diseases. an appreciation of the process of discovery with incomplete information and a recognition of the role of observations gathered painstakingly by scientists in the field shows that simple databases will not be sufficient to build causal models of the complex relationships between human health and ecosystems. rather, it is important also to build knowledge bases which complement databases using non-monotonic logic based artificial intelligence techniques, so that causal models can be improved as new, and sometimes contradictory, information is found from field studies. been designed to support researchers and interested citizens in collection and collation of biodiversity related data sets. concurrently, many other systems for biodiversity data have been created around the world, such as gbif , with applications ranging from species identification to reintroduction . modern algorithms using big data driven machine learning (ml) and neural networks (nn) , coupled with sensors with new capabilities such as bioacoustics and analytical approaches such as genomics , are used to complement traditional approaches of biodiversity conservation in situ and in vivo. meanwhile, data and models about human health are also becoming increasingly complex, as medical discoveries utilize new computation assisted approaches for health management from prevention to cure for the human body . in fact, biomedical technologies for curing human health ailments are being projected as the next frontier of growth for the global economy toward an ageless generation . looking to quickly tide over this global emergency, the medical community has been spurred on to develop a vaccine to protect the public and reduce individual risk. whereas a vaccine from the best minds in biomedical research will be welcomed by one and all, public health and biodiversity experts are now under pressure to speed up their work on preventive approaches which include early warning systems, delaying and hopefully even preventing such outbreaks, and if it occurs, better management of such outbreaks. the existing surveillance apparatus rightly concentrates on early outbreak detection among people, and includes containment and response. while new standards for interoperability are being adopted in india for clinical health of individuals, standards are silent about including causal information, such as wild and domestic animal surveillance for understanding the dynamics of the pathogen-host cycles between outbreaks. such long-term longitudinal surveillance provides insight into disease burden and helps detect possible predictable patterns in outbreaks at a much lower economic cost than responding after the pathogens emerge . in an attempt to create an integrated mechanism for surveillance, detection and treatment of such zoonoses, a multi-disciplinary engagement in the form of the roadmap to combat zoonoses in india (rczi) initiative was established in . the rczi had identified key thrust areas and provided several strategies for research and action. yet, largescale and long-term integrated surveillance, involving human, veterinary and wildlife monitoring have failed to materialise . as a consequence, we still lag in our understanding of the burden and dynamics of emerging and reemerging infectious diseases (erid). the indian government's integrated disease surveillance project (idsp), launched in , sought to establish a decentralised staterun india-wide surveillance programme. this programme began with the establishment of surveillance units at the district level, led by a district surveillance officer and a rapid response team to respond to outbreaks. the idsp has generated clear information flow on outbreaks of conditions and publishes periodic reports of outbreaks on their website . while the outbreak detection and rapid response functions are taken care of by the idsp, the programme is unable to integrate human and animal (livestock and wildlife) surveillance. this is not surprising given that the idsp is structured within the department of health and thus, there is limited scope for convergence with other departments. independent evaluations of the idsp have pointed out the need for its strengthening and have identified key limitations in achievement of timely outbreak detection and proactive monitoring of erids . an integrated human and animal surveillance system that collects primary data on disease parameters from people, livestock and wildlife is needed as it will improve our understanding of the dynamics of erids and as well as our response (both locally and also policies). globally, there are increasing demands for the establishment of responsive and scientifically sound surveillance systems to better understand the connections between deforestation, wildlife, and pandemic risk and, possibly to predict outbreaks and the spread of erids. recent reviews of surveillance systems have recognized that these need to be strengthened in developing countries. there is also moderate evidence to suggest that most efforts in strengthening response to zoonoses have been focused on "laboratory capacity and technical training, with relatively little attention given to the collection of field data, particularly at the interface between human and livestock populations" . health the biomedical profession is developing advanced algorithms using machine learning and neural networks to derive hypotheses with strong correlations to enable drug discovery for medicines and vaccines to address human health . the health industry has been captivated by cost savings through efficient transactions and better diagnostic outcomes through the use of artificial intelligence (ai) techniques . in fact, current systems of medical informatics focus on human biology only, with most of the research efforts evolving to solve health problems of the individual . even in the developed health care systems in the west, the vision of future medical systems does not include much about zoonotic diseases . some ai techniques are being used to further derive correlations using large data sets for individual human-centric medicine . meanwhile, there is much to be done to develop proactive, in silico models of one health for public health related applications for prevention and management of outbreaks. when causal models of outbreaks are known, j. indian inst. sci. | vol xxx:x | xxx-xxx | journal.iisc.ernet.in e.g., free-ranging dogs causing zoonotic diseases, targeted management approaches can be designed using modern tools such as agentbased modeling . however, the main difficulty with developing in silico causal models of one health are founded on the lack of data which can help us characterize the ecosystem of pathogens in which the human is simply one actor, who we tend to focus on. scientists are calling for the nmbh to create a decentralized, national system of surveillance of zoonotic disease outbreaks which also will collate data about ecosystems and biodiversity, since it is their degradation due to human actions which leads to erids. but is that enough? in fact, modeling such complex ecosystems requires us to understand the myriad behavioral patterns of pathogens and other actors who possess different contextual mechanisms of problem solving intelligence best described in the "ants on a beach" parable in herbert simon's classic book, sciences of the artificial, . it is, therefore, quite understandable that research in one health calls for decades long, painstaking, and heroic efforts to discover causal linkages which can provide sufficient data for deriving correlations with confidence , and which then can be used as predictive causal models. surveillance databases need to be coupled with such causal models in the form of knowledge bases to create useful artifacts, i.e., in silico models of one health. the one health system for data management is a necessary and immediate requirement to enhance our understanding and for rapid response to outbreaks. when such a data management system is available and continually updated, and if we know a well founded causal "law of nature", we can deduce conclusions from observations. for example: causal law: if all < humans with ixodes tick bites in the us > have < lyme disease > . observation: < arundhati > is a < human with ixodes tick bite in the us > . deduction: then < arundhati > has < lyme disease > . deductive rules are represented by the famous syllogism that: causal law: if all < men > are < mortal > . observation: < socrates > is a < man > . deduction: then < socrates > is < mortal > . however, the complexity of ecosystems and zoonotic diseases rarely present such simple situations for the application of rules of deductive logic. definitive causal laws of nature simply are not established or well founded. therefore, the analytical approach will still be reactive in nature and largely dependent on correlations between observations and hypotheses generated by the integration of knowledge from the diverse disciplines such as public health, epidemiology, and biodiversity. the research question is whether knowledge from disparate sources can be captured and utilized to create causal models which, in turn, are capable of generating hypotheses for a proactive response to erids. recent developments in ml and nn have proliferated in the data analytics community to solve many complex problems. similar to traditional time series forecasting methods, ml and nn algorithms work well when there is no dearth of data . some slight variations in the applications of such algorithms also allow for "learning" and deriving models that fit reality to an acceptable degree . in fact, all such more or less statistical methods allow for deriving causal models from large datasets for which virologists created the metaphor in fig. the rules of inductive logic are not as automatically applicable as the rules of deductive logic. however, when one has statistically representative datasets of the population, inductive rules can enable low-risk reasoning with some predictive capabilities. history is replete with stories of poor, inductive reasoning leading to beliefs which were difficult to revise. galileo would have agreed. perhaps the most interesting case of reasoning for problem solving arises when there is paucity of data. in such cases, problem solving requires that we make hypotheses and test them as we obtain more information. the painstaking gathering of information, leading to incrementally improving hypotheses leads scientists to causal models such as the one developed by scientists working on kfd. the causal models, often represented as directed graphs, show the current state of knowledge based on whatever information is available. that is: causal law: if all < migratory birds from russia > have < encephalitis > . observation: < kfd > has same origins as < encephalitis > . abduction: then < kfd > will be in < migratory birds from russia > . but, < kfd > could be indigenous! and, in fact, this was the logic that was used in the quest to find kfd, and found to be an erroneous assumption. abductive rules are represented by the famous syllogism that: causal law: if all < men > are < mortal > . observation: < socrates > is < mortal > . abduction: then < socrates > is a < man > . but < socrates > could be a dog! abductive reasoning carries significant risk, and can lead to dangerous assumptions which can have subsequent knock-on effects. furthermore, such hypothetical models carry the inherent risk of being disproved when additional information conflicts with the information gathered to date. the scientific method essentially incorporates such "abductive" reasoning based on hypothesis testing, and it was in full display in the mystery of the kfd outbreaks which re-emerged after half a century as an erid in india. abductive reasoning was applied to develop hypotheses that small mammals on the forest floor could be the reservoirs for kfd and yet again, was proven wrong. through a process of hypothesis testing, causal chains such as 'small mammal-haemaphysalis-small mammal' chain, the 'small mammal-ixodes-small mammal' chain, and 'small mammal-haemaphysalismonkey' chain were all eliminated. before the development of data intense techniques like ml and nn, the science of ai cultivated sophisticated methods to enable building artifacts, i.e., in silico problem solving knowledge bases to emulate such reasoning and support incremental development of causal models. the current causal model (fig. ) for the reemergence of kfd was traced to human interventions which reduce biodiversity and provide opportunities for the virus to infest species that they otherwise may not have. the important lesson from the kfd story is that for different types of reasoning to be applied, it is important to develop tools which go beyond simple databases to store and retrieve datasets. it will be important to develop statistical approaches to enable the use of large datasets. but more realistically, it will be important to assist the ecologists, field biologists, epidemiologists, and other scientists with systems which can represent the current state of knowledge, that can be changed as more information is obtained to consolidate and revise the best known models of the time. models based on incomplete information can be dangerous. they can set up societal trends that can influence societies in good and bad ways . as the world responds to the covid- crisis with emphasis on health financing , it would behoove us to invest in technologies that actually assist one health scientists in building not only databases, but also their knowledge bases toward prevention and management of zoonotic diseases. investment in developing such comprehensive artifacts for one health is the need of the day. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. received: august accepted: september j. indian inst. sci. | vol xxx:x | xxx-xxx | journal.iisc.ernet.in nitin pandit is the director of the ashoka trust for research in ecology and environment (atree) in bangalore, india. previously, dr. nitin pandit was the director of priority initiatives at the world resources institute (wri) in washington, dc, usa, focusing on restoration and energy efficiency. prior to this assignment, he was the ceo of wri india and led wri's work in india. he was responsible for formulating and implementing wri india's strategy, including a new program in the restoration of degraded lands. before wri, nitin was president of international institute for energy conservation (iiec), with offices and programs in a dozen countries, for implementing novel sustainable energy approaches for developing countries, such as market transformation, energy-efficient buildings, and demand-side management using renewable energy hybrids and energy efficiency improvement. in the s, nitin formed a boutique high-tech consultancy specializing in artificial intelligence (ai) applications in environmental and renewable energy systems. using ai, he developed tools and solutions for integrated "closed-loop" systems of water, energy, and materials, synoptic climatology, air pollution, and nonpoint source pollution. in the s, nitin worked with reputed consulting firms in the areas of pollution prevention and waste management, geohydrology and geotechnical construction, and water resources engineering. nitin has a bachelors and couple of masters' degrees in engineering, and a doctorate in public policy. abi t. vanak is a senior fellow (associate professor), and convener of the centre for biodiversity and conservation with the ashoka trust for research in ecology and the environment (atree). he is also a fellow of the dbt/wellcome trust india alliance clinical and public health program. his research areas include animal movement ecology, disease ecology, one-health, savanna ecosystems, invasive species and wildlife in human-dominated systems. much of his research work focuses on the outcome of interactions between species at the interface of humans, domestic animals and wildlife in semi-arid savannas and agro-ecosystems. under onehealth systems and disease ecology, he studies dynamics of rabies transmission in multi-host systems and the role of small and medium mammals in the transmission dynamics of kyasanur forest disease. abi vanak has a master's in wildlife biology from the wildlife institute of india and a ph. d. in wildlife science from the university of missouri. current causal model for kfd (credit: ita mehrotra -model ling-the-chall enges -of-manag ing-free-rangi ngdog-popul ation s?commi t=bee e adbc a dbd c cf -at-antintel ligen ce-the-wrong -way- #:~:text=in% his % % boo k% c% the ,the% com plexi ty% in% the % ant . accessed date com/ -facts -about -time-serie s-forec astin g-that-surpr ise-exper ience d-machi ne-learn ing-pract ition ers- c ee . accessed date com/a-short -intro ducti onto-model -selec tion-bb bb c . accessed date /press relea sepag e.aspx?prid= . accessed date research options for controlling zoonotic disease in india integrating one health in national health policies of developing countries: india's lost opportunities key: cord- -r n g authors: núñez, ana; madison, maria; schiavo, renata; elk, ronit; prigerson, holly g. title: responding to healthcare disparities and challenges with access to care during covid- date: - - journal: health equity doi: . /heq. . .rtl sha: doc_id: cord_uid: r n g nan viruses know no boundaries, but the impact of pandemics highlight faulty health systems and at-risk individuals. the novel coronavirus of - pandemic has hit certain groups of people within the united states more severely than others. those living in underserved areas, often with financial hardship, and black and brown individuals, are more prone to experience sickness and death from the virus. this roundtable discussion brings together several experts from various fields related to health equity to address these disparities and recommend actions needed to attain equity. dr. ana nÚ Ñ ez: i recognize that identifying one top ranking priority is a challenge, as there are many. that said, what is your top-ranking priority during this current covid pandemic? what item most needs to be realized or addressed? dr. ronit elk: my number one priority is how culture influences and fundamentally shapes how people make meaning out of illness, suffering, dying, and death are, and how culture strongly influences people's response to getting a diagnosis to an illness, as well as treatment preferences. and the problem is that we have a lack of appreciation in the u.s. for the cultural differences that may and in fact do compromise care for seriously ill minority-i call them patients, but people. and that is my number one priority. dr. maria madison: thank you so much, dr. elk, for your comments, because my number one priority is fairness. when i think of fairness, i am thinking of investing in equitable access to prevention, mitigation, and treatment for covid. that includes looking out for the most vulnerable populations and their needs for basic things, including clean water. when we say prevention is easy, that we should wash our hands for seconds, it is easy to forget that a large proportion of the population in the u.s., if not the world, does not have access to clean water, or the internet access to learn about best practices or threats to our food supply, but even more importantly, in order to assure that we try to protect our frontline workers, personal protective equipment (ppe) supply chain, investing in vaccines, or even investing in evidence-based treatments. so for me, the number one answer has to focus on promoting equity for all the reasons dr. elk just described. right now, we are seeing that a disproportionate number of people who are suffering and dying from covid- are black and brown folks. we can dig deeper into why that is when we get to the other questions, but it really draws attention to the inequity in our society that allows us to continue to oppress populations that are already at risk for all aspects of inequity. dr. renata schiavo: my number one priority is to protect marginalized and vulnerable populations from this pandemic and beyond. i feel pandemics have this very strong way of showing us how widespread social and health inequalities are, and how in the day-to-day they prevent people not only from protecting themselves, but also from leading healthy and productive lives. within the realm of vulnerable and marginalized populations, there are three main groups that come to mind as examples. first, there are children who live in poverty who may not be directly affected by the serious health consequences of covid- , but in many cases depend on being in school for their only meals. the pandemic has shown that in addition to school-based nutrition, we need to think of additional systems to deliver child nutrition to the + million children who live in poverty in the united states, especially in communities of color that have been marginalized and discriminated against for centuries, and experience high rates of poverty. the family first coronavirus act has tried to address these issues, but it is just a drop in the bucket compared to the needs we are facing. the second group is the homeless population. we talk about social distancing and washing hands. these are very difficult behaviors for people who live in shelters or in the street. we have seen communities coming together and trying to install temporary sinks. but again, we need more comprehensive interventions. and third, of course, the communities of color who are more significantly impacted. we are already seeing that the highest mortality is within black and brown communities. this has to do with a history of lack of investment in communities of color, poverty, racismplease let's use that word, and a variety of other issues that have determined a higher burden of health and social inequities. i will stop it here, but again, it was very difficult to talk about one priority, so i decided to make an example of populations within the ones that we need to protect. dr. nÚ Ñ ez: thank you. dr. holly prigerson: i direct the center for research on end-of-life care at weill cornell medicine. although my focus is on disparities, i have concentrated my research mostly on psychosocial influences on the poor or inadequate care at the end of life. my focus has been on mental health issues and how patients and families might feel abandoned, as well as how poor communication and lack of resources to attend to psychosocial needs are often overlooked in life-threatening illness, especially for marginalized patient populations and families. i look more at the intersection of how psychosocial influences might be affected and impact access to care, receipt of care, feelings of injustice that some people might have gotten a ventilator whereas other people may have been denied a ventilator. we are trying to leverage the available resources that we know exist to try to remove barriers to better care for everyone, but by targeting a lot of the psychosocial issues that we think really account for who gets what. augmenting much of what you all said, the area that i see and feel that is the priority from my perspective is something that sounds sort of simple: process. there is not a coordinated, integrated, thoughtful process right now. instead, we have this patchwork of competition where every institution and individual has to figure it out independently. the fact that there is not a coordinated and integrated approach that oversees this pandemic speaks to the fact that we only have a public health finance structure. we do not actually have a functional, robust public health infrastructure. this void increases adverse health risk for vulnerable, marginalized populations and stresses these populations and the system. it's very difficult to ignore this impact now because we are seeing the exposure of vulnerabilityrisking mortality rates is just one marker-which really speaks to the pressing issues of need for integration and coordination of public health and prevention. ultimately, it will affect everybody. the question is, is this our opportunity to take this challenge as an opportunity to do things differently, or do we go from here and not make the needed changes that can put us all in a better position? dr. prigerson: by saying ''process,'' that sounds more macro, conceptual, zoomed-out kind of approach. and i think related to zooming out, i would say communication is important as well. by ''communication,'' i am referring to barriers to effective communication to decision-making, to getting care, to receiving care, to working with families at home to connecting families with work and employment. it is communications about medical decisions but also more mundane responsibilities such as going to shop for food and pick up cleaning supplies and all the sort of ways in which this covid- has affected our lives. communication, and in particular, telecommunication appears to have become a normal part in the way of life for many of us. right now, this is how we are all communicating with each other, but it is important to bear in mind that access to telecommunications for certain communities might not be available. maybe health literacy might affect communication and understanding of medical choices before making decisions. i think communication is a key aspect in how this pandemic has adversely affected different communities. dr. madison: yes to ''process'' but it must be fair process. as of the time we are having this discussion, we are seeing states like alabama and washington creating triages that some are calling ruthless utilitarianism, because they are singlehandedly creating hospital practices with a process that may be likely to inhibit treatment and care for certain groups, again, including our most vulnerable populations. that is why we are seeing high rates of morbidity and mortality for black and brown folks. dr. elk: so most of us have defined the problem in terms of what is happening. i would like to discuss, when we get best practices, what happens in the hospital, because this is where the physicians and nurses and ethicists and so on, have to do. i will talk about how to make advance care planning decisions and how to incorporate leaders. my expertise is with african american communities. you must incorporate pastors in your ethics committees. if you do not do that, you could be doing something morally wrong. in the united states, they do not give sufficient respect to the pastors, who are not only leaders in terms of faith and spirituality, but in terms of everything else. dr. schiavo: i want to add something to what dr. prigerson was saying about the importance of communication in this moment. some of the main principles of communication, and especially risk communication, are trust, transparency, and community engagement. a lot of communication has not been meeting these principles because it has been conflicting. it has not included community leaders who actually have the real understanding of the communities for which this communication is intended, who are trusted sources. often these are the individuals who really know best about the needs, preferences, and priorities of specific communities, such as communities of color, children, and other populations. we need really to think of risk communication not as the rem-edy when things go wrong, but something we should be prepared for in advance, during inter-pandemic times. dr. nÚ Ñ ez: currently we are overwhelmed by news and social media activity. an important question for me is, how do vulnerable populations identify trusted sources of communication? dr. prigerson: we are actually trying to develop what we call a ''divine intervention'' that capitalizes on the trust that we have found that healthcare chaplains and hospital chaplains have, particularly among our black patients with advanced-stage cancer. in our studies, what we have found is that for whatever reason -we do not know the mechanisms -but when very sick, dying patients seek a hospital chaplain, they are more likely to sign a do not resuscitate order. they are less likely to die in an icu. they are more likely to enroll earlier in hospice. we have been trying to understand this, but we suspect it has to do with feelings of trust that may lead to an enhanced ability to communicate. leveraging the power and influence that healthcare chaplains have in this crisis might be effective. we think this may be a missed opportunity, because healthcare chaplains have the ability to understand where people in their communities are coming from, as well as talk the talk to physicians. dr. elk: there are two things i think are key and that may be promising aspects. one is in terms of transparency and reaching out to the community. at the university of alabama, birmingham, i have been involved with the school of public health, where we have reached out to the black pastors, housing authority and the dean of the medical school, who himself is black, and have set up a series of webinars. the first webinar was on saturday, april , . there were , people on the webinar. many of the people were from the housing authority, just regular people. many others were black people from the community. the whole point was to discuss all these issues. there were specific goals with this webinar: one was to help people in the community understand how this illness progresses and so on, and our dean did speak about that. a little bit too much jargon, but okay. and then, the other goal of the webinar was to educate participants on how to protect themselves. i am hoping that i can partner with the housing authorities and we can create culture-based messaging, because creating messaging that the white man and the white middle-class has developed for the large audience does not work. we know that. so i wish we would stop doing that. and so we did create culture-based messaging, and we are going to continue to do that. what i am begging hospitals to do is to include leaders who are black, alongside other ethnic groups, on ethics board before making decisions on protocol for care allocation. failing to do that is failing to care about the black population and can lead to lawsuits, which is discussed heavily if bottom dollar is what the institution cares about. i do not care if you have already got a policy. change it. revise it. the other thing is, there is a lot of pressure in the united states for having a written advance care directive. that is not going to work in the black community, particularly in the south. if i sign something saying, ''do not resuscitate my mother, you will do nothing. as it is, you do nothing for our people. why should i sign a piece of paper?'' so do not pressure people. and if i say that culture influences how you make decisions, in the black community in the south, it has been shown that millions of people have held belief in the concept of, ''there could be a miracle. god can make a miracle happen.'' i do not know why people have such difficulty with this, since so many people read the old testament, where the word ''miracle'' is everywhere. but it is very, very difficult for physicians to understand this concept. if a miracle can happen, then you have to do everything that you can for the patient until they decide. another thing is that nobody dies alone in the black community. there will always be a pastor or somebody who will sit with them. in this time of covid- , we have people sitting alone. there are a couple of practices that i have seen that could be used. one thing that can be done is to have someone sit with the patient, remembering that this is somebody's loved one. yes, it may take hours, and yes, there are other patients to care for. but there is always someone who can sit there and be with the person and pray with them and maybe sing a church song with them. that act can be tremendously meaningful. the other thing is funerals. we know what happens at funerals. it is not only blacks. in israel, they have had the ultra-orthodox, who went to funerals where there were thousands of people. the percentage of the virus in that community is very, very high. what can we do? one way is to have the funeral through facebook, where singing and praying can be facilitated through a virtual platform. i also heard from a pastor who was talking about his grandfather who passed away from covid- . his grandfather was a very, very senior, very respected black pastor. thousands would have come to his funeral, but could not because of the virus. instead, they had five people go into the church and record music. five people somewhere else recorded the sermons. then they put it all together and people from the church drove up and were able to see the whole video they created this way. dr. madison: i want to prevent the deaths. i want us to think about why % of covid- deaths in places like chicago are black folks. i want the country to take a public health approach, which starts with prevention. in terms of prevention, the reason why we are seeing these rates of morbidity and mortality is because of rationing. the reason we are seeing rationing is because of the lack of planning on the national level, the lack of taking lessons not just previous pandemics and plagues, but also from other countries that have already determined and discovered. for example, cordon sanitaire does not work, so we need to do physical distancing. we need to promote social connections so we can promote sociobehavioral health and well-being. when we do not put ourselves into a situation where we have to ration, we should see fewer deaths, and we should see much less suffering, particularly in vulnerable populations. i think the fundamental problem is that we have gotten into a situation where we have to ration. so why are black and brown folks dying more? is it because of rationing of ventilators? is it because of rationing and not providing an environment where there is equitable access to treatment, equitable access to screening? we have to look at the entire chain of events that happens. it begins with prevention, and making sure we do not have to get into a situation of rationing. rationing is one of the root causes of why we are seeing this demographic differential in morbidity and mortality. when it comes to states determining who is the most worthy, who should be the first in line to have access to screening, treatment, ventilators, it is not our black and brown folks who are already immunocompromised, who are already in high-risk groups from obesity, diabetes, and hypertension. we need to do whatever we can to reduce this pandemic of rationing. we need to promote case finding in all populations. we need to promote contact tracing. we need to promote screening. we need to learn the lessons, not using cordon sanitaire. it reduces trust. it does not promote communication. we need to increase fact-checking and transparency in reporting on who is most infected versus affected. there is so much we could go into related to the cares act and joblessness and the relationship between joblessness and comorbidities, for example. but i saw this one data point that described how for every % increase in unemployment, it leads to a . % increase in opioid addiction. the pandemic's economic effects alone will exacerbate our drug and mental health problems down the road. we are developing a lot of psychosocial interventions that deal with the opioid epidemic and how people are responding to this pandemic psychologically, especially when they are unemployed and at home and life looks hopeless. alcohol sales have skyrocketed. people are going to self-soothe, and that is going to cascade to a whole bunch of problems down the road. but that is not what i wanted to react to. what i was wondering, in terms of process and in terms of equity and thinking down the road, is what happens when people feel that there was an unfair distribution of who got saved, who got the ventilator? what could be done now to have more transparency in the icu to support decision-making? there was recently an editorial by daniella lamas in the new york times about the decisions and the criteria for deciding which patients would benefit from getting a ventilator and which would not. ironically, or paradoxically, in end-of-life care, there are always recommendations like, ''do not put an advanced cancer patient on a ventilator anyway. it is futile. you are wasting valuable resources, and it is burdensome, and they are not going to survive.'' so that is not a good use of a very scarce resource. how can those rules about who should live and who is going to be put on a ventilator be made more equitable so to address the concern down the road, so there are not lawsuits saying, ''you discriminated against equally needy patients who would benefit from scarce resources but denied care for other reasons.'' a real quick answer goes back to what dr. elk had said before. your triage committees need guidance documents, and those should be written by ethics committees that are representative of the community. so you should have black ministers involved. you should have every demographic and profession included in your ethics committees to collaborate in creating these guideposts so that it is not left up to an individual, implicitly biased practitioner. dr. elk: and having just one black person is not enough. that is insufficient. dr. nÚ Ñ ez: at least from what i am hearing from other physicians, they are desperate for these equitable protocols. in the absence of protocols, clinicians are having to make the decision in the moment with so many things happening in terms of the trauma, lack of ppe, and so on and so forth. healthcare providers are desperate for these equitable protocols. and i will just remind you that we know data that say, if you have a committee, and % of that committee is not representative of the population, you do not have voice. so it is important when we are looking at these committees that it really is that percentage of the committee to bring that voice into the equation. but i will tell you that equitable protocols are desperately sought by healthcare providers who are in the trenches having to make these decisions, and with no time, on top of being under-resourced and potentially unsafe. dr. elk: there is a hashtag on twitter, #pallicovid, used by the palliative care community, linking to all kinds of resources that can help. the reality is, probably only the palliative care physicians or clinicians are looking at it, but others need to as well, because this is the group that has the expertise. now, unfortunately, even though palliative care is the group that has this expertise, they do not and have not been trained in determining cultural aspects of care. that is why a paper on cultural aspects of care, especially at end of life, is so, so key. health equity just published my article and in it we include a table with information about the differences in approach for how to talk to southern black and white patients. and who determined that? the community members, both black and white. everything that is in there is a cultural guide for clinicians. now, this was done in the rural south. i have no idea if it works up north. dr. prigerson and i are going to be collaborating on another study to see to what extent that works up north. but at least, if you respect what the community has asked, then you will go a very long way in showing respect, which, in turn enhances trust. and those additional suggestions of having somebody there with a black person, when they are ill, using facetime so the family can sing and pray with the patient as they are dying. how difficult is that? it is not difficult. it can easily be done. you want to build trust? do that. and by the way, i do not believe that it is a waste of resources, particularly for people whose culture believes god can create a miracle, and if that is what the family wants and believes, then we should respect the patient and/or family's values and act according to their established goals of care. it does not matter if medically it seems like, ''oh, this person will live and this person will die.'' you have to be equitable, as dr. nunez says. the issue of preparedness is of the utmost importance. we definitely need more preparedness for a variety of different issues. for example, i published with co-authors a systematic review, which perhaps is still the only review on communicating risk in epidemics in low-and middle-income countries, and also includes eligible studies on marginalized and at-risk populations here in the united states. some of the things we have been discussing resonate with the findings of the review, which point to the importance of communities and community engagement. as supported by several studies included in the review, when community members and families were involved, communities or patients were also more likely to adopt and embrace mitigation measures. another lesson that we learned from ebola: we cannot go into communities and tell them to suspend traditions for burials and funerals during a time of crisis. we need to think about culturally sensitive rituals to substitute for existing traditions during the preparedness phase. so again, the preparedness process is really key. i'd like to change the topic. in addition to engaging community leaders in finding solutions for issues related to the rationing of scarce resources (for example, the use of ventilators or protective equipment) so that we prioritize vulnerable and underserved populations, especially communities of color, professional associations representing the black and latino communities should also become involved. these associations should consider issuing guidelines that physicians and nurses desperately need to treat and prioritize patients who most need these resources, especially in disparity settings. finally, i had prepared something on paid leave, because among the most promising changes that i see happening-that, again, is not sufficient to meet the actual need-is the family first coronavirus response act, as related to the provision of paid leave for at least some of the workers. i am not an economist, but unfortunately, this provision is really a drop in the sea, because we know that up to million people will be excluded from this provision. on the other hand, people need to stay home as a way of protecting themselves. but we know that a lot of people are excluded from the paid leave provision, and would need to choose between protecting themselves or paying rent and putting food on the table. and this happens primarily within the food service industry and other industries where the people are really on the front line of the epidemic, and/or where workers are from communities of color, or women, or from other vulnerable populations. although the family first coronavirus response act is a step forward, we need to engage communities to make it more of a reality for all americans, because paid sick leave is something that is important not only during this pandemic, but it actually is a human right to be able to take care of one's health and the health of others during times of crisis and beyond. so, it is a step forward, but it is a fraction of what we need. we talked about isolation, opioid use, and issues related to mental health. i think it also bears mentioning that issues of intimate partner violence go hand in hand with alcohol use and gun sales. it is also worth recognizing that both morbidity and mortality, for women, is also likely to explode during this pandemic. many of the places that are being serviced that support victims of intimate partner violence are not-for-profits that receive federal funding, and these are going to be places with incredible need, especially in a time where there is isolation, alcohol, unemployment, et cetera. it bears mention. the most uncertainty in terms of the future of preserved food supply, ways of moving forward to continue living, are all on the backs of populations that are predominantly the ones that have been most discriminated against, or who suffer and bear the burdens in terms of inequities. these are not necessarily the ones who have free access to be able to get on the internet to find information. and even if they do, to other people's points, it is in such a high level of jargon, or written in english language when the individual maybe doesn't speak english. we need much more profound translations of that content to support health literacy as a way to get messages out for everybody, from pastors to communities, because one of the challenges that i see as a physician is that suddenly everybody is interested in science. science is not perceived as being irrelevant anymore. science is not a ridiculous thing. science is not something that people do not need to know about, and suddenly people are wondering, ''what do you mean by immunity?'' i think this is fabulous, but i am not sure that those messages are effectively reaching the communities of need. we need to be able to make those connections and parlay into building trust. currently, there are too many mixed messages. dr. elk: one of the things that you said about community is key. one of the research methods that is very, very appropriate, however extremely difficult to do in a very tight timeline, is community-based participatory research, where you could partner with the community. to reach the communities, we have to work in partnership with them. we can do a community-based research project where we can develop prevention guidelines in words the community will understand and according to the community's values. even if we can only determine feasibility, the goal will be to help save some lives. but if we can determine that this is a method that we can do when the next crisis comes, we will be ready to have such studies. and to add to what dr. schiavo said, i would like to stress, we have to learn from what happened in the ebola epidemic, when whites were attempting to provide aid, they did so without paying respect to the culture. they did not listen to the people experiencing the health crisis. they did not incorporate the culture of the people into it. if you fail to incorporate the culture of the local people, you are doomed to failure, and more people will die. it is a matter of cultural humility that people have to learn, and especially physicians, who unfortunately do not effectively receive this as part of their training. it is part of the nurses' training, but it is not part of the physician's training. dr.nÚ Ñ ez: i agree with you. i think that with the ''do to'' rather than the ''do with,'' mentality, especially with the scarcity of key equipment right now, there is a propensity to say ''let us do something.'' this results in, ''here is the shortcut that lets us something.'' and i think that the best thing to do, even though it may take a bit more time, is actually reaching out and including community networks to create a better outcome in the end if there is a matter of trust. dr. schiavo: actually there is evidence also from the ebola crisis such as for example some interesting case studies on sierra leone and liberia from unicef showcasing that when communities finally got involved, not only in research and intervention design, but also in the implementation and the evaluation of solutions, and in building trust in the community about the recommendations for protection, finally, the ebola epidemic subsided. , and i think this is a very important lesson, especially because in the united states, i feel we do not integrate enough community engagement in intervention design, implementation and evaluation. we have imported to a certain extent the community health worker model, but for the most part this model is being implemented in a very limited way because we primarily train people to disseminate information that experts designed. it is not really the same as the kind of community consultative process we need, especially in moments of crisis when we really need to empower communities, giving them ownership of solutions. there is a long list of steps that countries such as taiwan, singapore, and others took that both flattened the curve faster, and reduced the prevalence of disease and mortality. in that long, wonderful list is the item that they addressed the issue of disease stigma and compassion. i do not know where that exists in our state-by-state plans. we do not really have a national plan. but that was listed as a policy in taiwan and it made considerations for those affected by providing food and frequent health checks. it also included encouragement for those under quarantine. and the rapid response included hundreds of action items in their supplement. but just imagine including disease stigma and compassion as a part of the process. dr. elk: andy slavitt is one person who has shown unbelievable compassion and action. he was the head of president obama's medicare and medicaid cms, and helped develop the affordable care act. he is very knowledgeable and very connected. he has taken it upon himself to develop an organization called the united states of care. andy slavitt has put together so many initiatives. for example, he set up a site where ventilators can be shipped from one place to another, even before there were other initiatives. his group also set up a step-by-step guide for bringing resources to underserved communities. (see appendix s ; ª united states of care campaign and reprinted with permission.) so you can take it into your state, and all you need is the governor of that state, for example, to follow this step-by-step guide. now, let us see how many states use this incredible model. in terms of resources, i do not want to plug too much of what we are doing, but we are developing online resources to aid communication between families, between families and medical professionals, particularly in the life-threatening icu situation. but also we are developing tools to prevent people from dying alone and funerals not being able to happen in accordance with and culturally specific cremation and burial practices. we are developing an app that actually is a virtual memorial. we have developed something called the living memory home to help families in that time-it is not going to be a substitute for actually convening and having face-to-face ceremonies at some point, but the idea is, i think people are really struggling with this forced separation and lack of communication as everyone-everyone is essentially a shut-in right now. we are all shut-ins. and when your loved one is dying in the hospital, and you are shut in, regardless of your race or ethnicity, you are upset, you are frustrated, and you need tools to help you communicate better and more effectively. the other point i wanted to make in listening to everyone's' great suggestions, is that all our suggestions are essentially top down. community-based participatory research is great in that a lot of voices are heard. what should recommendations to actual families do? what should be some of the simple patient prompts or family caregivers' checklists for things that they should do to help them protect themselves and ensure their interests? we are always thinking about how we can help other people through being very instrumental and telling them what to do or treating people differently. what can they do themselves to have their rights and interests and values respected? dr. nÚ Ñ ez: i certainly read that in some places patients actually got an ipad that is covered in plastic so that they are not alone, they can connect with some-body and so on and so forth. and if we are talking about best practices, whether it is a phone or any other kind of device, to support that connection when someone is critically ill or at the end of life, that is as instrumental as having an iv. now, granted, i would submit to you that in terms of dying in a hospital, dying alone is a very frequent thing and very culturally devoid thing outside of that hospital. and so perhaps this is a practice we need to bring in that, just like the iv, there is this digital access to music, to a spiritual advisor, to family, to singing, whatever that is, that as a person surrounded by all the illness in a hospital, they do not necessarily feel alone. as long as you attach it to something, it is not like you are mandating that another person necessarily be there, but if an iv is essential, then perhaps we are saying this as well, because we need to pay attention to the humanity of individuals as they go through this struggle. dr. madison: i think that what communities also need to do, particularly my community and black communities and international communities, is to destigmatize accessing mental health services. by destigmatizing access to mental health services, society also has to provide free services, right? so let's promote access to free telehealth, promote access to paid sick time if you are fortunate to have a job, and promote access to free testing and treatment. we should promote destigmatizing access, whether it is for behavioral health or clinical health care. but right now, some of the barriers to access are both inside and outside of the community, so we should somehow support bridging that. in massachusetts, the department of public health, through the massachusetts public health association, highlighted four action items. and i believe that the fourth one is the one we have not mentioned yet, is so important because it adds to an increase in prevalence and incidence of this pandemic, of covid- pandemic, and it is to enact a moratorium on evictions, foreclosures and termination of public benefits. what can the individual do about that? not much. if you lost your job and you call up unemployment assistance, you are not even able to get off the waitlist on that phone. people are waiting two, three weeks to get a response in order to get unemployment insurance. i want to also stress that people finding themselves unable to get through to a representative at the unemployment office should document their every try. and so in the process, you are getting someone telling you have to be evicted from your housing, and foreclosures, and losing your public benefits. so it is ecosocial theory. it is all around the lifespan of what is happening to our most vulnerable populations. some of what we can do within our group, within our community is to destigmatize access and promote lobbying and advocacy. but it really is oppression working through ideological, institutional, interpersonal, and internalized mechanisms. dr. elk: one of the things that dr. prigerson had raised was, what about doing something for the patient? there is a tool that was developed at uab in which the palliative care doctors said, ''we will sit with your patient. tell us.''-they have developed a little questionnaire. the patient's loved ones fill in the answers. ''what does he love talking about? what is important to him? what is the name of.?'' this is meant to help the practitioners get to know their loved one, the patient, intimately, and can help to represent the loved one in a very unique, individual way. there is also a tool for providers on how to communicate at this time, developed specifically for covid. all of that is both on twitter under #pallicovid, and also on facebook, which is much easier, and is covid- palliative care providers. it is open for anybody. i saw that , people are already on the facebook group as of the time of this discussion. it has all these tools. if the physicians and others are looking for tools, the palliative care people have the perfect tools. one of them deals with how to communicate and what to say. they use a lot of acronyms to help clinicians remember them. dr. schiavo: i want to highlight something that has not yet emerged from the last discussion, which is the digital divide. we all talk a lot about digital health, we talk about those apps. but these media approaches are not necessarily going to reach the vulnerable populations we need to protect, where word of mouth, community gatherings, churches, and similar channels and venues are still the preferred ways of communicating. we are already seeing that when school went online, some schools in disadvantaged neighborhoods were left scrambling to figure out how to provide online instruction. in addition to this, we are in the middle of an infodemic, and there is a lot of information and misinformation out there. easy and widespread access to social media, which we did not need to care about during h n , really have a prominent role in disseminating this misinformation. and although some of the vulnerable populations may not use social media as their preferred media of choice, they hear from other people who have read things on social media. so we need to be aware of these challenges and prepared to equip the public health infrastructure to react to hoaxes and misinformation. i was reading the other day that there were some hoaxes in africa saying that blacks were not susceptible to covid- . we need to be prepared to counteract misinformation, and the only way to do this is having, again, governments and public health agencies to work with community leaders, so that those leaders become our rock stars on social media and within other information settings. let's give them social media accounts. train them to use social media. let's do something that actually brings their trusted voices to the communities they reach, because whether these communities are on social media or not, they hear from others who are on social media. this is also another important aspect that may have an impact on training of the public health workforce and on the overall infrastructure. dr. nÚ Ñ ez: i want to agree with you. i mean, i will share with you that in terms of our community participatory research project, philadelphia ujima, we brought in the radio celebrities, because the radio celebrities are important from a cultural perspective with lower-income residents in the city. some of these radio celebrities had profound credibility, and whatever they said was viewed as true. unfortunately it is the case that right now there is no way to certify what is actually credible information. dr. prigerson raised the point that we have talked about a top-down approach, and dr. madison eloquently talked about how there is so much in terms of the infrastructure that does not exist, and topdown is important. but i think that some of the bottom-up is, how do we attend to the legitimate disenfranchisement of our at-risk populations, many of whom are saying, ''you do not really care about me. i am expendable. i can clean. i can pick in the fields for your food, but i am not going to have time off, and if i am a casualty of this pandemic, well, then, you do not really care. somehow i am supposed to continue to be engaged, maybe vote, and to be part of this process. how does it make sense when it seems that you all do not really care about me?'' and so i think that there is a component that we have to reach to address that legitimate disenfranchisement as well as figure out through culturally competent sort of communication about how can they have some agency in this, how do they recruit help for when their loved one is sick, identify who were all the individuals that need to be in the loop on that conversation? negotiating the health access process is difficult for most of us, even in better times. how can we streamline the process, provide navigation help during this global pandemic? i think that disenfranchisement linked with health, health literacy, and misinformation, or ''the infodemic,'' is an important part of the storm, and if we do not address that, no matter what happens top down, the disenfranchisement may very well explode. it is important to mention that disenfranchisement is a useful way to control the populace, because if everybody is looking at everybody else, the problem is always going to be that other person. it is us and them. the community affords strength, innovation, and cohesiveness in coming together to find and promote solutions. that being said, we are hearing in the media lots of amazing examples where people are coming together to form community. this is too often drowned out by the sensational stories of hoarding and price gouging. we do not hear the common acts of checking on the elderly neighbor and sort of going grocery shopping. we do not hear about that, because, again, that does not sell eyeball time for the evening news. it is important that we think about how to best use community-focused, inclusion-promoting messages as one of the antidotes to the infodemic. in response to all this, and the infodemic, we are developing some tools. we call them gist, ''giving information simply and transparently,'' so that when oncologists talk with advanced-stage cancer patients, you are disenfranchising patients if you talk about millimeters of tumor growth, or you talk about drugs for which they do not understand the mechanisms of action. we are developing this intervention to both address the infodemic, to simplify and clarify main talking points, and insist that physicians have patients leave a clinic visit doing what in psychology they call cognitive interviewing, ensuring that patients have enough information to make an informed choice-they do not need to know every single fact, but maybe the physicians or the medical community needs to decide what are the main kernels of medical information that, without which, anyone, regardless of race or ethnicity or language or education level, needs to know to make a choice that will resonate with them, that will be consistent with their values, and consistent with informed values. so we are trying to reduce disparities, but through education and information, both on the parts of having physicians communicate to empower patients to have the information they need, to insist on the care that might be consistent with what they would want. it dr. schiavo: i would like to say that pandemics have a way of showing us how much we are interconnected. taking care of everyone in our communities and being our brothers' and sisters' keeper is not only an important human rights issue but also benefits the health of everyone. i hope that this lesson is not going to be forgotten too quickly, as we have seen so many lessons be forgotten in the past. as dr. madison said, we really need to address all the social and political determinants of health so that we can advance health equity and racial equity in the years to come and protect people during this pandemic. in the meantime, i would like to ask for everyone to take the time to thank the people who are on the frontline. yes, the healthcare workers, but also the food and pharmacy cashiers, the sanitation workers, the hospital housekeepers and cleaners, and everyone who puts their life at stake every day, so that so many of us can stay safe. i think it is important to say thank you, because a lot of them are making huge sacrifices for the common good, and we need to do our share and at the minimum to thank them. dr. elk: in terms of prevention, please, work on partnering with communities to develop prevention messaging that is not as complicated as what's on the cdc or other health care sites, but is instead very simple, and not only that, takes cultural differences into consideration. just a photograph or a picture of a native american person or somebody in some tribal dress is absolutely insufficient. a lot of nurses already have training in cultural competency, but sometimes physicians don't have quite as much competency in this area. it is important for all practitioners to show cultural humility and to not talk down to patients, but to ask what their cultural values and preferences are. and then once you know them, respect them. and if you do not know, there are tools and guidelines to improve cultural competency. look at the article that we have just published in health equity. dr. prigerson: one thing that struck me as a way to synthesize what we have been talking about is the huge importance of communication in making sure that families are connected, that health professionals are connected, that people get adequate information, that people's preferences and needs are heard. it all depends on facilitating and improving communication between patients, families, communities, and the medical team. there is hope, but we also know that a lot of work needs to be done to improve not just access to care, but also to strengthen communication, and improve relationships between communities and healthcare institutions, between the federal government and constituents, and between practitioners and patients. communication needs to be facilitated so that people's needs are heard and respected. dr. madison: i have three nieces in the healthcare field. one is a black female physician, chicago. another black nurse in the la area, managing nurses. and the third, black female social worker. they all agreed on their answer to this question, and what they said was, ''let us work towards disease prevention and health promotion instead of a curative model for health care delivery.'' dr. nÚ Ñ ez: one of my favorite acronyms is pdq, which stands for partner-defined quality. if we can start with the pdq straight away, then hopefully we can take advantage of this opportunity for good. there is an asian proverb that says, ''the best part of my house burning down is i have a good view of the moon.'' in crisis, there is opportunity. we are awash with opportunity. the question, as has been mentioned so eloquently by many of you, is, do we then leverage this opportunity for the better in terms of efforts of equity, relationships, communication, infrastructure, to roll it back resulting in a robust, effective prevention model? we will be able to say, ''yeah, this is not just. we've learned from the spanish flu. covid- was the tipping point where we changed things up.'' i really, really appreciate all of your time. this was a fabulous conversation. it was just really a wonderful opportunity, and thanks so much for all your insights. ana núñez, md, is a professor of medicine and professor of obstetrics and gynecology, dean of diversity, equity & inclusion at drexel university college of medicine. her expertise includes sex/gender cbr and health and workforce enhancement for underrepresented populations. ''the first step is recognizing, acknowledging, and respecting the inequity, disrespect, and disregard our african american patients have experienced.'' holly g. prigerson is the irving sherwood wright endowed chair of medicine, co-director, cornell center for research on end-of-life care, and professor of sociology in medicine at weill cornell medicine. her research has been continuously funded for over years by the national institutes of health to examine issues of health care disparities at the end-of-life and psychosocial influences on and outcomes of those disparities. renata schiavo, phd, ma, ccl, is a senior lecturer at columbia university mailman school of public health, department of sociomedical sciences, and the founder and board president of health equity initiative, a nonprofit membership organization. she is a passionate advocate for health equity and a committed voice on the importance of addressing and removing barriers that prevent people from leading healthy and productive lives. she has significant experience with and has written on communicating risk and promoting disease mitigation measures in epidemics and emerging disease outbreak settings. dr. maria madison has built her career, since , around evidence-based research methods. this has included conducting and supervising significant public health projects with multicultural communities, often in resource constrained settings. she began her career as a peace corps volunteer in the democratic republic of the congo, (i.e., zaire), and continued working through the private and public sector. dr. madison is currently the associate dean for equity, inclusion and diversity at the heller school for social policy and management at brandeis university. she teaches on subjects such as intersectionality and bioethics. families first coronavirus response act: employee paid leave rights covid- 's impact on the black community: a conversation with health experts and faith leaders fee de db aa e b aad eb ce c afe e dd bc f ca ad c c ae b a cf d accessed one hundred sixteenth congress of the united states of america mental health in the age of the coronavirus. the new york times online alcohol sales jump % during coronavirus pandemic c. death toll tops , as cuomo warns on ventilators developing and testing the feasibility of a culturally based tele-palliative care consult based on the cultural values and preferences of southern, rural african american and white community members: a program by and for the community communicating risk and promoting disease mitigation measures in epidemics and emerging disease settings what the coronavirus law means for paid sick leave, family leave community care centers, community dialogue and engagement: key ingredients in sierra leone county: communities took the matter in their own hands response to covid- in taiwan: big data analytics, new technology, and proactive testing united states of care center for palliative and supportive care. covid- resources coronavirus: what misinformation has spread in africa? supplementary appendix s key: cord- -u g o authors: ofosu-poku, rasheed; anyane, gladys; agbeko, anita eseenam; dzaka, alberta delali; owusu-ansah, michael; appiah, mary owusu; spangenberg, kathryn title: preparing a young palliative care unit for the covid- pandemic in a teaching hospital in ghana date: - - journal: palliative & supportive care doi: . /s sha: doc_id: cord_uid: u g o the emergence of the coronavirus disease (covid- ) pandemic has necessitated an interim restructuring of the healthcare system in accordance with public health preventive measures to mitigate spread of the virus while providing essential healthcare services to the public. this article discusses how the palliative care team of the komfo anokye teaching hospital in ghana has modified its services in accordance with public health guidelines. it also suggests a strategy to deal with palliative care needs of critically ill patients with covid- and their families. the coronavirus disease , caused by the severe acute respiratory syndrome coronavirus (sars-cov- ), is an infectious disease first identified in december in the hubei province of china (world health organization, b). on account of its highly infectious and contagious nature, it has in the past months spread to almost every country of the world (reynolds and weiss, ) . ghana registered its first case on march (ghana health service, a). as the number of cases continued to rise steadily, measures were put in place by the ghana government to mitigate the spread of the virus. there was first a presidential ban on all public gatherings including the closure of all schools, which was followed by a closure of all beaches and the nation's borders (nyabor, ) . two major cities -accra and kumasiwere locked down for three weeks. although the restriction on movement has been revoked, the ban on public gatherings remains in force (communications bureau, ) . at present, the komfo anokye teaching hospital (kath) continues to run all its services, albeit, with the reduced number of patients at the outpatient clinics. palliative care services at the komfo anokye teaching hospital started in the latter part of . initially, all team members had primary duties they performed but made some extra few hours each week to start a weekly outpatient palliative care clinic or attend to inpatient palliative care consults received. the team now has three nurses trained in palliative care who are dedicated only to performing palliative care-related tasks. the three palliative care nurses work together daily. they are supported and supervised by two family physicians and a surgeon. each week, the team carried out home visits twice, organized one outpatient clinic, and attended to inpatients within h of receiving consults. each day had a lists of tasks to be accomplished which included patient care, preparing presentations, discussing studies to be undertaken, and reviewing strategies to expand palliative care within the hospital. in the latter part of , the team acquired a mobile phone to which all official contact to the team was to be made. the team also had a whatsapp platform to keep members updated with developments related to the palliative care unit in the hospital. the covid- pandemic required a new strategy of work, one that will protect staff from unnecessary exposure and risk but will keep essential services running (public health agency of canada, ) . at a hospital-wide level, outpatient clinic phone numbers were publicized to facilitate controlled attendance. for the first time the palliative care unit was listed in a major hospital communique such as this and that represents an important milestone for the team. furthermore, this mobile telephone access serves a significant tool in guiding our function moving forward. the team's restructuring included: . home visits to be suspended until public health guidelines suggest it is safe to do so. . all patients already with the team will be followed up on teleconsult basis. those who require refill of drugs will be provided the prescriptions electronically except for controlled drugs such as morphine, in which case a relative must come for the prescription and purchase it from the hospital. . one member of the team will remain in charge of all teleconsults with patients and receive referrals made via phone calls. . inpatient referrals will be booked and seen by at least one member of the team who will be on call and thus will be present at the hospital. where referrals are more than one, at least two members will report and see the patients. . as much as practicable, the team's policy of seeing inpatients within h of referral must continue to be adhered to. . details of services provided will be shared on the group platform for the entire team to be kept updated. . research proposal developments will continue as plannedpersons involved will work from home. as at may, , out of , individuals confirmed to be infected with sars-cov- had died in ghana, one of the first few deaths occurring at the komfo anokye teaching hospital (alamisi, ; ghana health service, b) . the number of people affected are on the rise, and it is inevitable that the number of deaths may rise too. it is quite probable that, if public health prevention measures are not properly instituted and adhered to, the death toll may be worse keeping in view the low-resource capacity of ghana's healthcare sector (associated press, ) . in ghana, death is viewed as the beginning of a new form of existence, for which reason death is celebrated by large funerals by many ethnic and religious groups (ekore and lanre-abass, ; ohene, ) . even among muslims who hold relatively simple funerals for the deceased, a congregation of at least , standing shoulder-to-shoulder, is desirable for the funeral prayer, and close relations take pride in bathing the body, applying perfume, wrapping the body in white cloth, and burying their loved one themselves (ibn al-hajjaj, ) . when these long held customs and beliefs, which bring a sense of closure to the family and aid them deal with the loss of a loved one, are threatened or to a large extent revoked because of the highly infectious disease and public health guidelines, it is inevitable that grief may be prolonged or complicated with its attendant impact on the psychological and physical health of family members (mayo clinic, ; weir, ) . it has been reported that the individual who died of covid- in kumasi has been buried under the supervision of relevant officials. the report further states that the family rejected any claim that their loved one died of covid- (ghanaweb, ) . although, in the case of this patient, the timing of burial was consistent with the belief system of the family, they could not perform any ritual with the body they would have wished to apart from the funeral prayer at the cemetery (ghanaweb, ). the potential challenges in the bereavement period for this family could be dealing with the 'stigma' of their loved one dying of covid- and the emotional trauma of not being able to perform death rituals for their loved one ("end coronavirus stigma now," ; world health organization, a, c). in order to meet the palliative care needs of critically ill patients with covid- , the following strategy (illustrated in figure ) was developed after discussions with the covid teaman interdisciplinary team of doctors and nurses in public health rasheed ofosu-poku et al. and infectious diseases, a pharmacist, a dietitian, a psychologist, and biomedical scientists. it is hoped that in such uncertain times, the palliative care team remains able to meet the palliative care needs of its patients and their families, either of covid- or any other life-threatening illness. ghana's coronavirus deaths rise to two; total cases now to africa should "prepare for the worst" with coronavirus, who says president akufo-addo lifts partial lockdown, but keeps other enhanced measures in place african cultural concept of death and the idea of advance care directives end coronavirus stigma now ( ) for immediate release: ghana confirms two cases of covid- situation update, covid- outbreak in ghana as at th man who reportedly died of coronavirus in ghana buried the book of prayer -funerals complicated grief coronavirus: government bans religious activities, funerals, all public gatherings why ghanaians are so slow to bury their dead public health agency of canada ( ) community-based measures to mitigate the spread of coronavirus disease (covid- ) in canada how coronavirus started and what happened next new paths for people with prolonged gried disorder world health organization ( a) coronavirus disease (covid- ) situation report - world health organization ( b) events as they happen. world health organization world health organization ( c) mental health and psychosocial considerations during the covid- outbreak key: cord- -cvvyf cb authors: kelley, patrick w. title: global health: governance and policy development date: - - journal: infectious disease clinics of north america doi: . /j.idc. . . sha: doc_id: cord_uid: cvvyf cb global health policy is now being influenced by an ever-increasing number of nonstate and non-intergovernmental actors to include influential foundations, multinational corporations, multi-sectoral partnerships, and civil society organizations. this article reviews how globalization is a key driver for the ongoing evolution of global health governance. it describes the massive increases in bilateral and multilateral investments in global health and it highlights the current global and us architecture for performing global health programs. the article closes describing some of the challenges and prospects that characterize global health governance today. recent inspection rates it would cost the fda $ . billion and take more than years to inspect the , foreign facilities involved with registered food production for export to the united states. governance structures for building consensus and for collectively managing public health actions are necessary because the world's inhabitants cannot create societies and economies that are largely self-contained and insulated from outside threats. the world's inhabitants increasingly share the same air, water, exposure to infectious diseases, foods, pharmaceuticals, and health workforce. through climate change, the impact of human activities in a few countries can affect harvests, the epidemiology of infectious diseases, and the potential for global natural disasters. even among countries with strong public health programs, harmonization of standards and processes is important for effective and efficient collective action. today's global health governance structures include a complex web of un agencies, public/private partnerships, donor and recipient governments, foundations, corporations, and civil society organizations. a recent report from the kaiser family foundation identified multilateral international health treaties, commitments, partnerships, and other agreements, of which are legally binding under international law. the united states is a party to of these of agreements, of which are legally binding. these agreements cover many topical areas, including specific diseases, environmental issues, trade and intellectual property, specific populations (eg, refugees or children), health security/preparedness, water, and food/nutrition. in the aftermath of the nineteenth-century international sanitary conferences that focused on threats to ports and trade, the early twentieth century saw international $ , global health governance reflected in new institutions, such as the international sanitary bureau (isb) based in washington, dc, and the office internationale d'hygié ne publique in paris. the isb subsequently became the pan american health organization, which since has been one of regional offices of the who. when the un system was conceived in , brazil and china proposed the who. the who constitution contains several key principles, including: health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition. the health of all peoples is fundamental to the attainment of peace and security and is dependent upon the fullest co-operation of individuals and states. the broad mandate of the who has core functions: the provision of collective health leadership, the shaping of research as well as the generation and dissemination of knowledge, the setting of norms and standards and the promotion and monitoring of their implementation, the production of ethical and evidence-based policy options, the provision of technical support and capacity-building, and the monitoring of health situations and trends. the organization has a -point agenda: promote development; foster health security; strengthen health systems; harness research, information, and evidence; enhance partnerships; and improve performance. this agenda is shaped at annual meetings in geneva by the member countries that compose the world health assembly. an -person secretariat based in geneva and at the regional and country offices performs who programs. the breadth of the programs undertaken is vast, although not always deep. some of the topics addressed include hiv/aids; malaria; tuberculosis; chronic noncommunicable diseases; mental disorders; violence; traffic safety; visual impairment; maternal and child health; aging; disasters; health equity; environmental health; nutrition and food safety; drug access; research; health systems strengthening; and tobacco, alcohol, and drug abuse, and other unsafe behaviors. when the who was envisioned, the concept of its operations was quite vertical and focused primarily on relationships with member states. few other actors were engaged in global health. since its founding, the who has celebrated major accomplishments but has also suffered from an erosion of its influence. beyond the eradication of smallpox (an event that has likely saved more than million lives since ), who technical leadership has also played a role in the near eradication of polio; the containment of the deadly sars epidemic; the landmark who framework convention on tobacco control (the first treaty negotiated under the auspices of who); and the revision of the international health regulations (ihr). compared with the previous ihr that was focused on classical diseases of international importance, plague, yellow fever, and cholera, the revision is more powerful and practical in that it encompasses all acute public health risks of transnational significance. the new ihr defines broad reporting requirements and establishes the authority of the who to initiate disease-control actions, if necessary, through use of information sources other than country governments. the new ihr also requires countries to strengthen their existing surveillance capacities. many have hoped that the who would take a stronger role in the setting and enforcement of norms, given its extraordinary constitutional authorities and its quasi-legislative power to adopt binding regulations. the who has, however, leaned more toward providing technical advice than toward exerting bold, proactive leadership through binding norms and regulations. kelley given its mandate, the who is handicapped by a modest budget and by its dependent fiscal relationships. the proposed budget for to was $ . billion before currency adjustments. because only about . % of the who budget comes from the dues assessments of member countries, its flexibility in focusing its program based on the scientific priorities it determines is constrained. wealthier countries pay larger assessments and thus have more influence over the direction of who programming than poorer countries, which have the greater need for help. moreover, the remaining . % of the budget is projected as "voluntary contributions," which are largely earmarked by donors for specific purposes. this arrangement contributes to fragmented programming and perhaps to certain donor-influenced compromises. in this century, the who also faces growing challenges. although its members are sovereign governments, many other powerful actors (including nongovernmental entities, such as other un agencies, foundations, corporations, and civil society organizations) have entered the global-health arena. placating these competing interests is not a recipe for bold action. the who is the lead un agency for health. owing to the increasing recognition that health is fundamental to the broader un goals of fostering the international rule of law, global security, economic development, social progress, human rights, and world peace, health issues have now taken a more prominent place than they had in the united nation's first years. in , world leaders came together at the un headquarters to adopt the millennium development goals (mdgs), of which are focused on health. the leaders of un member states agreed to partner to achieve these goals by . the health-related goals have directly provided high-level, consensus global health policy direction (box ). another goal is related to hunger reduction. regrettably, the mdgs lack a target for chronic diseases, such as cardiovascular diseases and cancers, which now account for more than % of the global burden of disease. since , progress toward the mdg targets has been mixed. for example, between and , the number of individuals infected with hiv placed on antiretroviral drugs rose from , to million (ie, % of the . million people in target c: have halted and begun to reverse the incidence of malaria and other major diseases by need). in developing countries, % of births in still took place without a trained birth attendant present, and maternal mortality remains shockingly high. as a result of the hiv/aids pandemic and its immense scale and impact on human life, dignity, rights, social cohesion, and economic development, a un general assembly special session issued a formal declaration of commitment on hiv/aids in june . that declaration endorsed the establishment of the "global aids and health fund," which would pool contributions from countries and from the private sector to fund hiv prevention and treatment efforts. it also set out a policy approach to providing leadership; improving prevention, care, and treatment; preserving human rights; reducing the vulnerability of women and children at risk for or affected by hiv/aids; and mobilizing financial resources. a un special session on noncommunicable diseases and their prevention will convene in september . as illustrated in box , the un has spawned a wide array of specialized agencies and other entities with direct or indirect interests in health. to some degree, these compete with the who for legitimacy and resources, and some have a significant role in global health governance. in world trade organization treatment, especially among migrants, women and girls, peacekeepers, travelers, and orphans; it unites the relevant un agencies, civil society organizations, governments, and the private sector; it advocates for rights, resources, and accountability; it empowers actors with strategic information; and it supports country leadership. created by the general assembly in for post-war relief, unicef is now focused on providing on-the-ground, long-term humanitarian and developmental assistance to children and mothers in developing countries. funded by governments and the private sector, the unicef expenditures totaled $ . billion. based in rome, the food and agriculture organization of the united nations (fao) operates through regional offices and through more than country offices around the world. with a biennial budget in to of $ . million, the fao leads un efforts to enhance food security and to eliminate hunger, the number-one mdg. the fao provides a neutral forum in which all countries can negotiate agreements and debate policy. its experts disseminate technical information and assist countries with disease outbreaks and in developing sound agriculture policies. where issues of human health and animal health intersect (eg, avian influenza or food safety emergencies), the fao plays a role. although not actually a un agency, the world organization for animal health (previously known as the office international des epizooties and still known as the oie) is also an intergovernmental organization; it seeks to perform global disease control for the animal population. based in paris and having regional and subregional offices worldwide, the oie is an important partner of the who, the fao, and the world trade organization (wto). like the who, it operates under the collective control and authority of an assembly of member countries. oie relevance to global health governance stems from the often-underappreciated connection between human health and animal health. this connection, embodied in the one-health concept, is most evident in the context of emerging zoonotic diseases and food safety. in , an institute of medicine (iom) committee concluded that the oie rules lacked critical provisions found in the who ihr, provisions that would be valuable for an organization involved in protecting animals capable of transmitting infections to humans. the committee recommended that the oie create legally binding obligations for members to develop and maintain core surveillance-and-response capabilities, that the oie be authorized to publically disseminate the animal-disease information received from nongovernmental sources when the member state does not do so in a timely and accurate way, and that the oie director general be empowered to declare animalhealth emergencies and related recommendations as appropriate. the wto, a member of the un family since , is primarily concerned with the rules of trade between nations. with globalization, however, trade and health are increasingly connected. the wto has several agreements related to health and health policies, including the agreements on technical barriers to trade; the sanitary and phytosanitary measures; the trade-related intellectual property rights (trips); and the trade in services. although trade can be restrained for scientifically valid reasons related to health, relevant interpretations can be controversial. some health issues relevant to wto agreements include food safety and protection from zoonotic diseases; trips patent protection for pharmaceuticals (to balance incentives for drug development vs ensuring affordable access to drugs); tobacco control; biotechnology; and the transnational migrations of health workers, patients, and investment in health services. the world bank group, founded in , is a critical source of financial and technical help for developing countries. headquartered in washington, dc, it employs more than , people worldwide. the bank provides low-interest loans, interest-free credits, and grants to developing countries for health and other purposes. the world bank consists primarily of unique development institutions owned by member countries: the international bank for reconstruction and development (ibrd) and the international development association (ida). the ibrd serves middle-income and creditworthy poorer countries; whereas, the ida mission is to serve the world's poorest countries. ibrd lending is primarily financed through aaa-rated bonds sold on the world's financial markets; the ida funds come from donor countries and are replenished periodically. additional funds come from repayments of loan principal on longterm, no-interest loans. the ida accounts for more than % of world bank lending, and its loans are largely supervised and evaluated by the world bank country offices. ida loans have been used to improve sanitation and water supplies, support immunization programs, and combat the hiv/aids pandemic. in fiscal , the world bank health, nutrition, and population program lent $ . billion, a -fold increase from . since , the bank group provided $ billion in country-level project financing and $ million in private health and pharmaceutical investments. in fiscal , the bank disbursed $ million for existing hiv projects and committed nearly $ million to new hiv/aids efforts. it also committed funds in fiscal for pandemic preparedness. achieving the mdgs will require an estimated $ billion to $ billion annually. higher-income countries have made substantial policy commitments to support the lower-income countries that have insufficient resources to provide a basic package of essential health benefits (estimated at $ per capita per year). funding for action by wealthier countries has often been coordinated through governance mechanisms, including the annual group of eight (g ) summits. g progress toward these commitments is summarized in table . in , the un millennium project estimated that to meet the mdgs, the total overseas development assistance (oda) from high-income countries would need to rise to . % of gross national income (gni). in absolute terms, the us government has contributed great amounts to oda; however, as depicted in fig. , the relative amount contributed in was only . % of us gni, a figure less generous than the percentage contributed by most european countries, australia, and canada. the us government's global health program, compared with that of many other donor governments, cuts across many departments. it draws upon both the foreign-assistance structure but also the government's extensive public health capabilities. in addition to well-known actors, such as the us agency for international development and the us centers for disease control and prevention, executive branch agencies with a significant involvement in global health include the departments of state, defense, agriculture, homeland security, labor, and commerce, as well as the national institutes of health, the food and drug administration, the environmental protection agency, the peace corps, and the health resources and services administration. these agencies carry out programs in more than countries and are overseen by more than congressional committees. the us financial commitment to global health has dramatically increased over the last decade, especially with the implementation of the president's emergency plan for aids relief (pepfar) and the president's malaria initiative (fig. ) . originally authorized in at about $ billion, pepfar focused on countries, mostly in africa. over its first years, pepfar sought to support antiretroviral treatment for million people infected with hiv; prevent million hiv infections; and provide care, including care for orphans and vulnerable children, for million individuals. the program has been viewed as a major success for us global health policy. with wide bipartisan support, pepfar was reauthorized in for another years at $ billion, with substantial increases in the prevention, treatment, and care targets. the legislation also authorized $ billion for tuberculosis programming and $ billion for malaria efforts. although pepfar represents a landmark us achievement in global health, it also illustrates how policy can be skewed by nonscientific factors. fig. shows that among i r e l a n d f i n l a n d u n i t e d k i n g d o m s w i t z e r l a n d s p a i n f r a n c e g e r m a n y a u s t r i a c a n a d a a u s t r a l i a n e w z e a l a n d p o r t u g a l u n i t e d s t a t e s g r e e c e j a p a n i t a l y health called for a rebalancing of this portfolio to better support initiatives against noncommunicable diseases, malnutrition, and injuries. the signature global health program of the obama administration, the global health initiative (ghi), aims to provide $ billion in health assistance between and . although hiv/aids still dominates the ghi, increased investments are being made for neglected tropical diseases, malaria, maternal and child health, and family planning (box ). the aims of the ghi are to implement a woman-centered and girlcentered approach; increase impact and efficiency through strategic coordination and integration; strengthen and leverage key partnerships, multilateral organizations, and private contributions; encourage country ownership and investing in country-led plans; improve metrics, monitoring, and evaluation; and promote research and innovation. the us government's policy commitment to global health has been greatly lauded as a reflection of our vital health and economic self-interests, our humanitarian values, and "smart power." [ ] [ ] [ ] in many ways, it is an important form of diplomacy; however, some aspects of it may also hinder diplomatic prerogatives. some forms of oda can be used as leverage in diplomatic negotiations, but once a patient infected with hiv is taken into a pepfar-funded treatment program, it would be unethical for the us government to threaten the loss of those lifesaving drugs for diplomatic advantage. beyond un agencies and national governments, the global health enterprise is now a much more horizontal and networked endeavor than it was even years ago. although this makes it harder for the who to lead, it also brings a wider array of talent and resources to bear on problems. fig. illustrates an example of the partnership paradigm of global health governance today: the roll back malaria (rbm) partnership, a -member collaboration. even though the who was one of the founders of rbm and hosts the secretariat, it is not positioned as the dominant core of the effort. the rbm partnership not only works to facilitate policy coordination at the global level but also executes an operating framework with performance targets reflective of the mdg malaria goal; it articulates technical strategies and provides multidirectional accountability through its partners forum. a decision-making partnership board with members ( ex-officio) represents the broad rbm constituencies and meets periodically. there are voting members of the board representing foundations ( seat), malaria-endemic countries ( seats), multilateral institutions ( seats), ngos ( seats), organization for economic cooperation and development (oecd) donor countries ( seats), private sector ( seats), and research and academia ( seat). the stop tb partnership (http://www.stoptb.org/) also has many similarities to rbm. founded in , the global alliance for vaccines and immunizations (gavi) is another innovative partnership that links developing-world governments and donor governments; philanthropic foundations; the financial community; vaccine manufacturers from developed and developing countries; research and technical institutes; civil society organizations; and intergovernmental entities, such as who, unicef, and the world bank. immunizations funded by gavi have prevented an estimated . million deaths in developing countries. gavi also supports innovative financing box the goals and targets of the us government global health initiative hiv/aids: the us president's emergency plan for aids relief will: ( ) support the prevention of more than million new hiv infections; ( ) provide direct support for more than million people on treatment; and ( ) support care for more than million people, including million orphans and vulnerable children. malaria: the president's malaria initiative will reduce the burden of malaria by % for million people, representing % of the at-risk population in africa, and expand malaria efforts into nigeria and the democratic republic of the congo. tuberculosis (tb): save approximately . million lives by reducing tb prevalence by %, which will involve treating . million new tb cases and , multidrug-resistant cases of tb. maternal health: save approximately , women's lives by reducing maternal mortality by % across assisted countries. child health: save approximately million children's lives, including . million newborns, by reducing under- mortality rates by % across assisted countries. nutrition: reduce child undernutrition by % across assisted food-insecure countries, in conjunction with the president's feed the future initiative. family planning and reproductive health: prevent million unintended pregnancies by meeting unmet need for modern contraception. contraceptive prevalence is expected to rise to % across assisted countries, reflecting an average annual increase of percentage points. first births by women younger than years should decline to %. neglected tropical diseases: reduce the prevalence of neglected tropical diseases by % among % of the affected population, and eliminate onchocerciasis in latin america by , lymphatic filariasis globally by , and leprosy. data from available at: http://www.usaid.gov/ghi/factsheet.html. mechanisms, such as advanced market commitments to reduce the costs of immunizations needed by developing countries. the un declaration of commitment on hiv/aids called for the establishment of a global fund of pooled contributions to support hiv/aids needs. this global fund to fight aids, tuberculosis, and malaria (gfatm), unlike the previously mentioned partnerships, has as its sole focus mobilizing and distributing financial resources in a manner driven by technically sound national plans and priorities and principles of transparency and accountability. the gfatm is a partnership between governments, civil society, the private sector, and affected communities. more than countries have pledged funds to the gfatm; other major donors include the bill and melinda gates foundation, unitaid, and chevron. about $ billion has been pledged, of which more than $ billion has already been paid. with funding approved for more than programs in nearly countries, the gfatm is the source of onequarter of all international financing for aids globally as well as for two-thirds of that for tuberculosis and three-quarters of that for malaria. an innovative fiscal contribution to solving the crisis of antimalarial drug resistance and the dwindling number of effective drugs has been the creation of the affordable medicines facility for malaria (amfm). conceived by the iom committee on the economics of antimalarial drugs, the amfm was designed to re-engineer market forces to favor the effective treatment of resistant malaria through the appropriate use of artemisinin-containing combination antimalarial drugs (acts). in the committee recommended the commitment of $ to $ million per year to subsidize the entire global act market to create a steady supply of affordable and desirably priced acts in all malarious areas. several donors accepted this recommendation. the amfm was established by the gfatm and initially capitalized with more than $ million. although the greatest sources of funding, technical support, and leadership will continue to come from donor governments, recipient governments, and un agencies, contributions from the world of philanthropy have never been more significant. early in the twentieth century, rockefeller philanthropy supported efforts to eliminate hookworm, first domestically and then internationally. it has since taken on many other disease-control efforts directed toward conditions, including malaria, schistosomiasis, yellow fever, and vaccine-preventable childhood infections. in , it created the china medical board to develop modern medicine in that country but arguably its most significant contributions to advancing global health governance were investments to establish the johns hopkins school of hygiene and public health as well as schools of public health at harvard and the university of michigan. reflecting the emergence of the new era in global health governance, in the rockefeller foundation established an initiative to create innovative new public-private partnerships, including the medicines for malaria venture, the global alliance for tb drug development, and the international partnership on microbicides. over the years, many other foundations have made important contributions to facilitating global health action, including the ford foundation, atlantic philanthropies, the carnegie corporation, the bloomberg family foundation, the burroughs wellcome trust, the burroughs wellcome foundation, and the doris duke charitable foundation. the most noteworthy newcomer is the bill and melinda gates foundation. with assets of approximately $ billion, the gates foundation is the largest private philanthropy in the world. its current annual disbursements are approximately $ billion, much of which goes to global health. among foundations, its major commitments to gavi (at least $ . billion), the rotary international polio-eradication effort ($ million), and the gfatm ($ million) give it a uniquely powerful and sometimes controversial voice in global health governance. its investments in research, implementation, and advocacy encompass enteric and diarrheal diseases; hiv/aids; malaria, pneumonia, tuberculosis, and neglected and other infectious diseases; family planning; nutrition; maternal, neonatal and child health; tobacco control; and vaccine-preventable diseases. private funding now accounts for almost one-quarter of global health aid. unlike the foundations previously mentioned, the william j. clinton foundation is not a grant-making organization. for nearly a decade, however, it has been a unique contributor to advancing global health. by capitalizing on the influence of former president bill clinton, this foundation has catalyzed many initiatives. among these initiatives have been tremendous gains in access to hiv/aids treatment through negotiations with suppliers of drugs and diagnostic tests. through successive agreements, suppliers to low-income countries have reduced the prices of first-line treatments by %, pediatric medicines by %, and second-line hiv/aids medicines by a cumulative reduction of %. over the last decade, the corporate sector has also been making an increasing mark on global health. although corporate initiatives are too numerous to catalog in detail, their donations of drugs are especially noteworthy. since , for example, merck has donated ivermectin for the control of onchocerciasis (river blindness) worldwide. in , in partnership with glaxosmithkline, this commitment was expanded to include the elimination of lymphatic filariasis; ivermectin and glaxosmithkline's albendazole were coadministered in african countries and in yemen (countries where lymphatic filariasis and onchocerciasis are coendemic). over years, more than billion treatments for these infections have been provided though a large partnership. johnson and johnson donates enough mebendazole each year to treat million children for intestinal helminthes; boehringer ingelheim donates nevirapine to prevent mother-to-child transmission of hiv. pfizer has proved to be a valuable and innovative partner with its support for capacity-building activities, such as the pfizer global health fellows program. each year, this program deploys up to talented employees to work on high-impact, capacity-building projects in developing countries. similarly, bd strengthens capacity through a partnership with pepfar to improve laboratory systems in countries highly affected by hiv/aids and tb. the emerging corporate role in global health is not limited to companies focused on the business of health. companies as diverse as exxonmobil, warner brothers, and nike have engaged in important partnerships focused on controlling malaria, hiv/ aids, and violence against girls. american cyanamid has donated millions of dollars of the larvicide temephos to support guinea worm eradication efforts. formal business coalitions have developed to take on issues of malaria, tuberculosis, and hiv/aids. the role of civil society organizations in global health predates all of those entities previously named. the who lists ngos with which it has an official relationship. as the who notes: no longer the domain of medical specialists, health work now involves politicians, economists, lawyers, communicators, social scientists and ordinary people everywhere. the involvement of civil society has profoundly affected not only the concepts underpinning public health but the formulation and implementation of public health programs and policies as well. global health: governance and policy development civil society organizations span a wide array of secular and faith-based entities. they include groups with a disease-specific orientation; groups with a professionalspecialty focus; charities that work on the ground; and global professional service organizations, such as rotary international. (rotary international is a key global partner in the who campaign for polio eradication. ) perhaps the most exciting recent development in the united states has been the explosion in interest in global health education at universities. suffice it to say that if governance is the constellation of mechanisms a society uses to effect collective action toward common goals, then the catalyst of the many new us multidisciplinary university programs in global health education will initiate and energize an unprecedented level of collective action. despite the vast inflow of resources for global health, the remaining policy challenges are significant. perhaps today's most acute global health challenge is achieving the health-related mdgs. current trends indicate that none of these basic targets will be near achievement by . overall access to care is still lacking or suboptimal for billions of people. access to clean water and essential medicines is uneven. modern pharmaceuticals are often unaffordable or unavailable. globalization has brought some health benefits to the world's poorest, but it has also fostered the transnational spread of infectious diseases, the brain drain of skilled health care workers from developing countries, and the trade in poor-quality food and pharmaceuticals. surveillance for human and animal diseases is of variable quality and the enforcement of the relevant regulatory regimes needs improvement. despite the challenges that remain in coordinating the many diverse players now engaged in global health, the vast increase in the commitment of both private and public wealth over the last decade is to be celebrated. commitments have gone far beyond money and have brought forth legions of individuals who choose to commit themselves in the global context to the universal value of health. research is steadily discovering and developing new technological interventions. new mechanisms of cooperation have been developed, and there is a growing interest 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sustaining global surveillance and response to emerging zoonotic diseases world trade organization/world health organization the world bank annual report -year in review. the international bank for reconstruction and development/the world bank millennium development goals for health: what will it take to accelerate progress? global health policy: the u.s. government's global health policy architecture: structure, programs, and funding committee for the evaluation of the president's emergency plan for aids relief (pepfar) implementation. pepfar implementation: progress and promise. institute of medicine public law - . united states global leadership against hiv/aids, tuberculosis, and malaria reauthorization act of the institute of medicine committee on the us commitment to global health. the u.s. commitment to global health: recommendations for the public and private sectors report of the csis commission on smart global health policy: a healthier, safer, and more prosperous world america's vital interest in global health: protecting our people, enhancing our economy, and advancing our international interests the institute of medicine committee on the u.s. commitment to global health. the u.s. commitment to global health: recommendations for the public and private sectors no good deed goes unpunished: the unintended consequences of washington's hiv/aids programs the global fund to fight aids, tuberculosis, and malaria -pledges about the global fund saving lives: buying time: economics of malaria drugs in an age of resistance rockefeller foundation-our history governing global health global health fellows: pfizer investments in health. available at: https:// globalhealthfellows.pfizer.com/login.asp?returnurl home.asp. accessed september bd's global health initiative global business coalition on hiv/aids, tuberculosis and malaria world health organization. list of ngos in official relations with who world health organization. civil society initiative (csi) rotary international/the rotary foundation the dramatic expansion of university engagement in global health: implications for us policy: a report of the csis global health policy center key: cord- -yzum k authors: moon, suerie; sridhar, devi; pate, muhammad a; jha, ashish k; clinton, chelsea; delaunay, sophie; edwin, valnora; fallah, mosoka; fidler, david p; garrett, laurie; goosby, eric; gostin, lawrence o; heymann, david l; lee, kelley; leung, gabriel m; morrison, j stephen; saavedra, jorge; tanner, marcel; leigh, jennifer a; hawkins, benjamin; woskie, liana r; piot, peter title: will ebola change the game? ten essential reforms before the next pandemic. the report of the harvard-lshtm independent panel on the global response to ebola date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: yzum k nan the west african ebola epidemic that began in exposed deep inadequacies in the national and international institutions responsible for protecting the public from the far-reaching human, social, economic, and political consequences of infectious disease outbreaks. the ebola epidemic raised a crucial question: what reforms are needed to mend the fragile global system for outbreak prevention and response, rebuild confi dence, and prevent future disasters? to address this question, the harvard global health institute and the london school of hygiene & tropical medicine jointly launched the independent panel on the global response to ebola. panel members from academia, think tanks, and civil society have collectively reviewed the worldwide response to the ebola outbreak. after diffi cult and lengthy deliberation, we concluded that major reforms are both warranted and feasible. the panel's conclusions off er a roadmap of ten interrelated recommendations across four thematic areas: preventing major disease outbreaks all countries need a minimum level of core capacity to detect, report, and respond rapidly to outbreaks. the shortage of such capacities in guinea, liberia, and sierra leone enabled ebola to develop into a national, and worldwide, crisis. • recommendation : the global community must agree on a clear strategy to ensure that governments invest domestically in building such capacities and mobilise adequate external support to supplement eff orts in poorer countries. this plan must be supported by a transparent central system for tracking and monitoring the results of these resource fl ows. additionally, all governments must agree to regular, independent, external assessment of their core capacities. • recommendation : who should promote early reporting of outbreaks by commending countries that rapidly and publicly share information, while publishing lists of countries that delay reporting. funders should create economic incentives for early reporting by committing to disburse emergency funds rapidly to assist countries when outbreaks strike and compensating for economic losses that might result. additionally, who must confront governments that implement trade and travel restrictions without scientifi c justifi cation, while developing industry-wide cooperation frameworks to ensure private fi rms such as airlines and shipping companies continue to provide crucial services during emergencies. when preventive measures do not succeed, outbreaks can cross borders and surpass national capacities. ebola exposed who as unable to meet its responsibility for responding to such situations and alerting the global community. • recommendation : a dedicated centre for outbreak response with strong technical capacity, a protected budget, and clear lines of accountability should be created at who, governed by a separate board. • recommendation : a transparent and politically protected who standing emergency committee should be delegated with the responsibility for declaring public health emergencies. • recommendation : an independent un accountability commission should be created to do systemwide assessments of worldwide responses to major disease outbreaks. rapid knowledge production and dissemination are essential for outbreak prevention and response, but reliable systems for sharing epidemiological, genomic, and clinical data were not established during the ebola outbreak. • recommendation : governments, the scientifi c research community, industry, and non-governmental organisations must begin to develop a framework of norms and rules operating both during and between outbreaks to enable and accelerate research, govern the conduct of research, and ensure access to the benefi ts of research. • recommendation : additionally, research funders should establish a worldwide research and development fi nancing facility for outbreak-relevant drugs, vaccines, diagnostics, and non-pharmaceutical supplies (such as personal protective equipment) when commercial incentives are not appropriate. we do not have the capacity to respond to this crisis on our own. if the international community does not stand up, we will be wiped out. we need your help. we need it now.n aimah jackson, team leader, médecins sans frontières ebola treatment center, monrovia. address to the un security council, sept , the west african ebola epidemic that began in was a human tragedy that exposed a global community altogether unprepared to help some of the world's poorest countries control a lethal outbreak of infectious disease. the outbreak engendered acts of outstanding courage and solidarity, but also immense human suff ering, fear, and chaos, largely unchecked by high-level political leadership or reliable and rapid institutional responses. the outbreak continues as of november, . it has infected more than people and claimed more than lives, brought national health systems to a halt, rolled back hard-won social and economic gains in a region recovering from civil wars, sparked worldwide panic, and cost several billion dollars in short-term control eff orts and economic losses. , guinea, liberia, and sierra leone were most badly aff ected. the ebola outbreak is a stark reminder of the fragility of health security in an interdependent world, and of the importance of building a more robust global system to protect all people from such risks. a more humane, competent, and timely response to future outbreaks needs greater willingness to assist aff ected populations, and systematic investments to enable the global community to perform four key functions: . strengthen core capacities within and between countries to prevent, detect, and respond to outbreaks when and where they occur. . mobilise faster and more eff ective external assistance when countries are unable to prevent an outbreak from turning into a crisis. . rapidly produce and widely share relevant know ledge, from community mobilisation strategies to protective measures for health workers, and from epidemiological information to rapid diagnostic tests. . provide stewardship over the whole system, entailing strong leadership, coordination, priority-setting, and robust accountability from all involved. the ebola outbreak emphasised failures in performing all four of these functions. clarity about roles, responsibilities, and rules-and accountability for adherence to them-is essential in a complex system that must involve local, national, regional, and international actors spanning the public, private, and non-profi t sectors. yet, this clarity and accountability was fundamentally absent. without addressing these governance issues, we will remain wholly unprepared for the next epidemic, which might very well be more devastating, virulent, and transmissible than ebola or previous disease outbreaks. [ ] [ ] [ ] the independent panel on the global response to ebola is a joint initiative of the harvard global health institute and the london school of hygiene & tropical medicine to review the global community's response to the ebola outbreak. the members come from academia, think tanks and civil society around the world, with expertise in ebola, disease outbreaks, public and global health, international law, development and humanitarian assistance, and national and global governance. the panel took a global, system-wide view with a special focus on rules, roles, and responsibilities to identify changes necessary to prevent and prepare for future outbreaks. this panel report outlines the main weaknesses exposed during diff erent phases of the ebola outbreak, followed by ten concrete, interrelated recommendations across four thematic areas: preventing major disease outbreaks, responding to major disease outbreaks, research-production and sharing of data, knowledge, and technology, and governing the global system, with a focus on who. our primary goal is to convince high-level political leaders worldwide to make necessary and enduring changes to better prepare for future outbreaks while memories of the human costs of inaction remain vivid and fresh. the ebola outbreak witnessed many types of failures. for analytical purposes, we divide the epidemic roughly into four phases, underlining the most salient issues that arose. during the initial phase from december, , to march, , the fi rst infections occurred in a remote rural area of guinea where no outbreaks of ebola had previously been identifi ed. the lack of capacity in guinea to detect the virus for several months was a key failure, allowing ebola eventually to spread to bordering liberia and sierra leone. this phase underscored the problem of inadequate investments in health infrastructure, despite national governments' formal commitments to do so under the international health regulations ( ), and awareness among donors that many lower income countries would need substantial external support. it also underscored inadequate arrangements between governments and who to share, validate, and respond robustly to information on outbreaks. in march, , a second phase began in which intergovernmental and non-governmental organisations began to respond, starting with médecins sans frontières, which already had teams on the ground. that month, both guinea and liberia confi rmed ebola outbreaks to who. by march , ebola was confi rmed in conakry, home to more than one in seven guineans. two months later ebola had spread to three capital cities with international airports. without any approved drugs, vaccines or rapid diagnostic tests, health workers struggled to diagnose patients and provide eff ective care. without suffi cient protective gear, and initially without widespread understanding of the virus, hundreds of health workers themselves became ill and died. despite médecins sans frontières' warnings about the unprecedented scope of the outbreak, national authorities in guinea downplayed it for fear of creating panic and disrupting economic activity. , internal documents suggest similar concerns might have infl uenced who, which publicly characterised the outbreak in march as "relatively small still". who's global alert and response network sent an expert team to support national eff orts, as did others such as the us centers for disease control and prevention. however, those teams withdrew from guinea and liberia in may when reported cases decreased, even as viral transmission continued. in late may, sierra leone became the third country to declare an ebola outbreak to who. for the fi rst time in the known history of ebola, the virus had spawned sustained outbreaks in three countries. this should have raised substantial alarm, as coordination was weak between the national governments of liberia, guinea, and sierra leone, the borders extremely porous, and human movement and trade highly fl uid. in late june, médecins sans frontières labelled the situation as "out of control" and publicly called for more international attention and resources. this second phase witnessed three interrelated failures. first, in a failure of political leadership, some national authorities did not call for greater international assistance despite the humanitarian crisis, and in some cases downplayed the outbreak. second, who's in-country technical capacity was weak, shown by its decision to withdraw its international team too soon and its poor responses in guinea and sierra leone to requests for technical guidance from ministries of health and health-care providers. , third, who did not mobilise global assistance in countering the epidemic despite ample evidence the outbreak had overwhelmed national and non-governmental capacities-failures in both technical judgment and political leadership. the third phase began in july as cases, global attention, panic, and responses all grew. funding increased, with the world bank committing us$ million in the fi rst major external fi nancing response. media attention and public interest substantially increased after the evacuation of two infected us aid workers from liberia. fear and hysteria in response to ebola infections in the usa later led to quarantines of returning aid workers and other measures counterproductive for controlling the epidemic. dozens of countries, private companies, and universities began implementing travel restrictions, and many airlines ceased fl ying into the region. on aug , who convened the international health regulations emergency committee, and the next day the director-general offi cially designated the ebola outbreak a public health emergency of international concern ("an extraordinary event which is determined...to constitute a public health risk to other states through the international spread of disease and to potentially require a coordinated international response." ) detected cases grew expon entially. ebola treatment centres in all three countries were stretched beyond capacity and forced to turn away patients at their gates. a growing lack of trust between population groups and government authorities hindered community mobilisation and public education. in the ensuing weeks, the global community mobilised, with new commitments of fi nancing, health personnel, and logistical support from the african union, china, cuba, the european union, the uk, the usa, the world bank, the international monetary fund, and the un agencies. the un security council passed resolution declaring the outbreak a threat to international peace and security, the only time it has done so regarding an outbreak and only the second resolution ever (after hiv/aids in ) to focus on a disease. the un secretary general created a new entity to coordinate the international response, the un mission for emergency ebola response. additionally, trials for two candidate vaccines were launched in europe and the usa, and who convened an expert group to develop guidance for the ethics of using experimental therapies. despite increased mobilisation of political attention and resources, this third phase witnessed several failures. first, public and private restrictions on trade and travel further harmed an already suff ering region and hindered control eff orts. , second, the operational response commenced slowly, taking months for funding, personnel, and other resources to reach the region. [ ] [ ] [ ] third, the creation of the un mission for emergency ebola response bypassed the pre-existing un body for emergency coordination, the offi ce for the coordination of humanitarian aff airs, further blurring the lines of responsibility for international coordination. fourth, fi eld staff often reinvented strategies for community mobilisation and contact tracing because relevant lessons from previous ebola outbreaks in uganda and the democratic republic of congo were not eff ectively transferred. fifth, international staff with ebola sometimes received experimental therapies (albeit, the effi cacy and risks of which were unknown) and were evacuated while national staff largely were not, a demoralising and often deadly distinction for many health workers. , sixth, there was poor understanding of how to take into account community beliefs, practices, and solutions, properly address rumours, and involve local leaders-with sometimes fatal consequences for health workers and communities. a fourth phase began towards the end of as the epidemic turned a corner. the total number of cases began to decline in the hardest hit countries as community leaders and organisations joined control eff orts, even before large-scale global assistance arrived. ebola had been imported into nigeria, mali, and senegal in the second half of . nevertheless, rapid information sharing, and mobilisation of health workers for contact tracing and patient care had limited the outbreak in senegal to one confi rmed infection. in nigeria, the nigerian center for disease control, previous experience with polio eradication eff orts and a lead poisoning emergency were all cited as important factors in successful control of the outbreak in africa's most populous country. by the end of january, , more than $ billion had been committed for the ebola response (although the proportion of these funds actually spent on ebola and in the aff ected countries remains unclear). research and development eff orts were quickly operationalised despite uncertainty on processes for regulatory approval, with at least three vaccine candidates, three blood products, and fi ve drug candidates in clinical trials, with who playing a coordinating role. during this phase, the binding constraints were no longer political attention, funding, or human resources, but operational coordination, accountability for eff ective use of funds, and maintaining momentum to prevent new infections. amidst the crisis, many acts of courage, solidarity, innovation, and leadership prevailed, often at a substantial personal cost. in west africa more than local health workers contracted ebola caring for the sick; more than of those caregivers died. community members volunteered to trace contacts, local leaders educated communities, and religious authorities promoted new burial practices to prevent transmission. several non-governmental organisations vocally advocated for a stronger global response, treated patients, trained health workers, supported community mobilisation and longer-term recovery eff orts. additionally to massive funding from traditional donors, the african union, the economic community of west african states, cuba, and china made substantial contributions of personnel, funding, logistics, and technology (huang y, council on foreign relations, personal communication). private foundations and companies contributed funds, with $ million from the top fi ve contributors, along with meaningful in-kind assistance, such as air lifts. the initiation and conduct of clinical trials were accelerated amidst the challenging conditions of an outbreak, enabled by the cooperative eff orts of industry, research funders, regulatory authorities in the usa, europe, and west africa, scientists, and directly aff ected communities. these positive steps notwithstanding, this panel's overarching conclusion is that the long-delayed and problematic international response to the outbreak resulted in needless suff ering and death, social and economic havoc, and a loss of confi dence in national and global institutions. failures of leadership, solidarity, and systems came to light in each of the four phases (panel ). recognition of many of these has since spurred proposals for change. we focus on the areas that the panel identifi ed as needing priority attention and action. preventing small-scale outbreaks from becoming largescale emergencies needs a minimum level of core capacities in all countries to detect, report, and respond rapidly (panel ). in the wake of the severe acute respiratory syndrome (sars) outbreak, governments committed to developing such core capacities by under the revised international health regulations ( ), with the deadline extended for some countries to , then after ebola struck. according to self-assessments, as of , two-thirds of countries had not met their core capacity requirements and countries had not responded to who queries regarding their readiness. the international health regulations did not include binding obligations for donors to provide support to poorer countries to meet these obligations, nor to fund who to fulfi l its mandate to provide technical assistance. these shortcomings did not attract serious action or funding until the ebola outbreak. despite unprecedented international fi nancing during the past decade to combat particular diseases in developing countries, health systems in many resource-poor settings remain ill-prepared for outbreak response. no alternate strategy has been developed to supplement these national-level weaknesses. if countries remain unable to detect outbreaks in a timely way, the rest of the chain of international health regulation-stipulated notifi cations and responses will fail once again. additionally, according to the international health regulations, countries agreed to report potential health emergencies within h to who for joint risk assessment, with the option of doing so confi dentially. who was also permitted to receive, analyse, and ask for verifi cation of outbreak information received from non-governmental sources. governments might hesitate to report outbreaks publicly for fear of political and economic repercussions, as occurred in china with sars in . yet, history has shown that early reporting is essential to reduce both the health toll of an outbreak and its political and economic consequences. governments agreed in the international health regulations to prompt notifi cation, and in return, were reassured of the curtailment of unwarranted trade or travel restrictions and support from who technical assistance. during the ebola outbreak, however, countries and many private fi rms implemented restrictions on travel or trade, despite who's recommendations against such measures and the security council's warnings about the resulting isolation of aff ected countries. , , [ ] [ ] [ ] [ ] we conclude that several concrete steps must be taken to prevent future outbreaks from becoming large-scale catastrophes. who should convene governments and other major stakeholders within months to begin developing a clear global strategy to ensure that governments invest domestically in building core capacities and to mobilise adequate external support to supplement eff orts in poorer countries. there is growing momentum in the wake of ebola for such investments: the us government has committed $ billion to build core capacities in at least developing countries, including guinea, liberia, and sierra leone. this work is being coordinated under the global health security agenda, a us-launched initiative that now consists of nearly countries. at its june, , summit, the group of (g ) announced support for countries, although the g did not explicitly commit funds nor agree to a concrete plan. financial commitments for recovery have also been made at various ebola conferences and summits. - other initiatives might also contribute to core capacity building. these include the gates foundation's child health and mortality prevention surveillance network, the joint institut pasteur-china centers for disease control initiative to train west african scientists in outbreak response, the merieux foundation's laboratory strengthening activities in west africa, and the uk's £ million fleming fund for antimicrobial resistance. these welcome signals need to become sustained budget commitments to support national or regional plans, such as the mano river union post-ebola socioeconomic recovery programme, and reviewed systematically beyond this initial phase at forums such as the g , the g , and the world health assembly. furthermore, dialogues about health security should not be isolated from broader discussions about development fi nancing, including of the sustainable development goals, as ebola exposed how substantially an epidemic could roll back hard-won development gains. a clear, coordinated plan, supported by a transparent central system for tracking and monitoring these resource fl ows, will be needed to minimise fragmentation and ensure that core capacities are systematically built and sustained. the proposed accountability commission for disease outbreak prevention and response (recommendation ) should monitor investments and results for core capacity building. further analysis is needed to estimate the required level of additional funding. strategic investments for international health regulation core capacities can and should also strengthen broader health systems. , for example, health information systems can support surveillance and monitoring of outbreaks and routine health services; training and payment of community health workers and civil society service providers can help achieve universal health coverage, while providing an essential trained workforce during emergencies. additionally, regional and subregional actors should develop capacities to supplement gaps at the national level. for example, in africa, national governments, the african development bank, and other donors should invest in the infrastructural backbone for a network of laboratories, information systems, and training of african national emergency responders based in centres of excellence. the pan american health organization has shown the feasibility of a regional network of centres for disease control, and building such a network could be a central task of the proposed african centres for disease control and prevention. although the african centres for disease control and prevention might be perceived as a competitor to the who regional offi ce for africa, a clear delineation of responsibilities for outbreak response versus other health issues should enable close collaboration between the two. finally, governments must agree to regular, independent, external assessment of their core capacities. monitoring requirements should accompany external fi nancing. assessments will also be needed in self-fi nancing countries. some governments objected at the world health assembly to independent assessment. nevertheless, a method for peer assessment piloted by fi ve countries through the global health security agenda could provide a basis for a monitoring process acceptable for all countries. political leaders, governments, and international organisations must strengthen the set of incentives and disincentives so that governments report disease outbreaks early. among these should be stronger disincentives for implementing trade and travel restrictions without a scientifi c or public health basis. who should promote transparency by publishing lists of countries that delay reporting disease outbreaks, while commending countries that rapidly share public information as mexico did in with h n . who publicly challenged china's government to be more transparent about sars, showing the organisation's potential political power. who should also publicly disclose lists of countries that implement trade and travel restrictions when who temporary recommendations advise against them and countries that do not provide a science or public health rationale for such measures (as required by the international health regulations). doing so will require a delicate balancing act between who's role as trusted interlocutor with governments on sensitive outbreak-related information, and its role as guardian of the international health regulations. although an individual government might object to such scrutiny in the short term, politically supporting who's prerogative to do so serves the long-term interests of global public health. funding bodies such as the world bank, the asian infrastructure investment bank, the african development bank, and the new development bank (previously known as the brics development bank) should create economic incentives for early reporting by committing to disburse emergency funds rapidly to assist countries when outbreaks strike and compensating for economic losses that might result. the world bank's proposed pandemic emergency financing facility or the african union's african risk capacity agency off er the possibility of insurance to mitigate the economic costs linked to outbreak reporting. the trigger for disbursement should be a risk assessment done under the aegis of who. because private fi rms such as airlines and shipping companies are not directly bound by public international law, alternate governance mechanisms are needed to prevent isolating countries when outbreaks strike. the these could include designating a un focal point for the private sector during outbreaks, designing industry-wide cooperation frameworks, and developing codes of conduct. if preventive measures fail and an outbreak escalates into a major crisis, responsibility for taking action and alerting the broader global community must be clearly designated (fi gure ). as noted, countries agreed as part of the international health regulations to notify who of any potential public health emergency of international concern within h of assessment. who rapidly shares information with the global alert and response network, a loose network coordinated by who of academics, government scientists, non-governmental organisations, and health volunteers. the global alert and response network analyses and assesses reports, deploys investigators, conducts laboratory examination and identifi cation of the outbreak cause, and advises on further measures, including, as a fi nal resort, a potential public health emergency of international concern declaration. however, the global alert and response network's skeleton staff is too small to deploy in multiple suspected outbreaks, its budget has been severely cut, and it is not authorised by who to draw public attention to a crisis. responsibility for declaring a public health emergency of international concern belongs to the who director-general, who convenes an emergency committee of independent experts for a recommendation. however, the director-general did not use her international health regulation-granted authority to convene the emergency committee nor declare a public health emergency of international concern until months after guinea and liberia had notifi ed who. in view of the severity of ebola virus disease, rapid cross-border spread, weaknesses of the aff ected national health systems, the post-confl ict setting, and repeated warnings from nongovernmental organisations in the region, the director-general had ample reason to raise international attention by convening the emergency committee or declaring a public health emergency of international concern earlier. the committee responsible for reviewing who's performance during the ebola outbreak (the who ebola interim assessment panel) and leaked internal emails suggest several reasons for the delay including concerns about political opposition from west african leaders, economic ramifi cations, and a culture within who discouraging open debate about sensitive issues, such as emergency declarations. , who might also have hesitated because it was sharply criticised for creating panic by declaring a public health emergency of international concern during the relatively mild h n pandemic. whatever the root causes, the delay emphasised the risks inherent in vesting such consequential decision making power in a single individual. this risk is heightened when there is no institutional mechanism of accountability for leadership failures. after the public health emergency of international concern declaration, a substantial global response was mobilised. however, this response arrived late, was slow to deliver funds and health workers, was infl exible in adapting to rapidly changing conditions on the ground, was inadequately informed about cultural factors relevant to outbreak control, and was poorly coordinated. the result was, in essence, a $ billion scramble. an excessive burden fell on national and international nongovernmental organisations and local communities to do the highest-risk work such as patient care and burials. the creation of the un mission for emergency ebola response as an ad hoc body operating outside established humanitarian response structures reportedly made coordination of the crisis response even more diffi cult. , funding was low until the upsurge of commitments in september, , and, even then, there were long lags between pledges and disbursement. by one account, national surveillance identifies event of concern assessment of public health risk ( h) affected country reports to who ( h) response at who headquarters response in country who director-general convenes emergency committee to assess for public health emergency of international concern; director-general consults affected state emergency committee advises director-general who issues temporary recommendation if national capacity is outstripped, international actors should supplement national efforts director-general withdraws public health emergency of international concern declaration in case of state failure, actors operate under un coordination public health emergency of international concern controlled emergency committee reviews public health emergency of international concern status and recommendation if disease crosses borders, affected governments coordinate responses with support from regional and global organisations nearly $ billion had been pledged by the end of but only a third of this money was disbursed. furthermore, transparency of fi nancial fl ows is crucial to minimise duplication, to ensure aid goes to areas of most need rather than those easiest to assist, and to ward against mismanagement. however, transparency was, and remains, wholly inadequate: on the donor side, multiple tracking systems exist but it remains impossible to construct a clear, comprehensive picture of monetary and in-kind pledges and disbursements across the many public and private donors. on the recipient side, who received what funds to do which tasks also remains an opaque puzzle-and assessing the eff ect or effi cient use of those funds is more diffi cult still. we off er three further recommendations to tackle these issues. high-level political leaders must clearly designate who is responsible for responding when disease outbreaks outstrip national capacities, invest in the capacity to respond, and ensure accountability for fulfi lment of these responsibilities. although national governments and nongovernmental organisations working on the ground are the fi rst line of defence when outbreaks arise, who is crucial for the second line of defence when governments need international support or when an outbreak strikes more than one country. to strengthen who's capacity during outbreaks, we welcome the stocking panel's recommendation to create a who centre for emergency preparedness and response, and off er several additional recommendations regarding its key functions and attributes. the centre should merge the outbreak risk assessment and response capacities that reside in the global alert and response network with who's humanitarian teams, which presently respond to natural disasters, refugee crises, and other large catastrophes. its operational lines of authority from headquarters to regions and countries should be clearly designated. the centre should assess risks on the basis of the information that countries and others provide to who, and mobilise necessary laboratory, epidemiological, clinical, communications, and logistical responses. it should have powerful analytical, data processing, and advisory capacity to command respect in both policy and scientifi c communities. the centre should develop rapid response and strong coordinating capacity, and be able to assemble the world's best expertise to tackle disease threats. between crises, the centre should develop protocols, build relationships, and negotiate agreements with governments, multilateral organisations, non-governmental organisations, private fi rms, and other actors to mobilise rapidly during emergencies, including strengthening capacities in developing countries so that they might better respond nationally and participate internationally. in a multicountry outbreak, the centre should ensure government-to-government coordination by establishing channels of direct communication for rapid information sharing. it should be responsible for building a virtual global health workforce from both industrialised and developing countries by setting standards for certifying crisis responders, ranging from communications experts and logisticians to surgeons and managers. these responders would continue working for their home organisations, but provide surge capacity in a crisis. finally, the centre should provide technical assistance to countries to build and maintain international health regulation-mandated core capacities. the centre should have its own executive director who is accountable for performance jointly to a separate board of directors and to the director-general. the multistakeholder board should include broad repre sentation of governments from each who region, scientifi c expertise including about animal health, operational responders from all sectors, and funders. the executive director should inform the board immediately when the centre's risk analysis suggests that coordinated international action is needed and mobilise an appropriate response. similar governing structures have worked eff ectively for who-affi liated entities including the global polio eradication initiative, the international agency for research on cancer, unitaid, and the special programme for research and training in tropical diseases. the centre's budget should be protected and adequately resourced through a dedicated revolving fund. the fund should immediately disburse money for rapid scale-up when a crisis strikes, then be replenished from funds raised for that crisis to be ready for the next one. the centre and its board should work closely and routinely with the director-general so that the highest levels of leadership are constantly aware of evolving disease threats, and can marshal who's legal, political, and human resources at regional and country levels when needed. who should use its international health regulation-granted authority to expedite access to aff ected sites by technical teams and pressure any state that impedes international responses to, or obscures, disease threats in its territory. the centre must have access to sensitive outbreak information that countries are required to share with who; further analysis is needed as to whether this would require amendment to the international health regulations. a third line of defence will be needed if the initial response does not succeed and an outbreak becomes a humanitarian crisis (eg, a un level emergency ), threatening not only public health, but also political, economic, and social stability. international coordination of the large-scale eff ort needed in this case should be done by the offi ce for the coordination of humanitarian aff airs. however, because the offi ce for the coordination of humanitarian aff airs (and most other humanitarian actors) do not specialise in crises precipitated by disease outbreaks, they should develop in-house capacity and a broad coordination framework with the health sector for such emergencies. member states should amend the international health regulations to broaden responsibility for declaring a public health emergency of international concern. the director-general convenes, and is advised by, an ad hoc emergency committee constituted from a list of independent experts; however, authority and responsibility to declare a public health emergency of international concern rests exclusively with the director-general. we recommend the creation of a standing emergency committee that meets regularly, with the mandate to declare a public health emergency of international concern by a majority vote of its members. the emergency declaration should trigger other actions, such as fi nancial disbursements by development banks, emergency data-sharing and specimen-sharing rules, and emergency regulatory procedures for new drugs, vaccines, and diagnostics (recommendations and ). the director-general should chair, communicate, and explain the standing emergency committee's decisions. following an open call for nominations, the director-general would appoint the fi rst members; thereafter, the standing emergency committee itself would periodically vote in new members to preserve its independent character. minutes and votes of standing emergency committee members should be published immediately following each meeting for the sake of transparency, to build external confi dence, reduce political interference, and strengthen the committee's hand against resistant states. similarly to other institutions responsible for technically complex yet politically consequential decisions, such as central banks or drug regulatory authorities, the standing emergency committee must be protected from political pressure that might interfere with its judgment. the committee should possess high-level public health expertise and base its decisions on scientifi c principles and evidence, assessing risks for human health, disease spread, and international traffi c. the standing emergency committee should have adequate economic expertise to weigh the risks of disrupted trade and travel against those posed by the outbreak and advise on how to ameliorate economic harm. the standing emergency committee should also issue early warnings of major potential risks on the basis of continuing assessments done by the who centre. the committee should also consider replacing the present binary system, which calls for determining the presence or absence of a public health emergency of international concern, with a graded system of warnings. finally, the standing emergency committee should publish an annual report detailing its activities to ensure public accountability and continued political attention to health threats. the committee should be fi nanced purely through assessed contributions to protect against undue donor infl uence. a committee does not by defi nition operate more eff ectively than an individual, and might succumb to risk aversion and dysfunction; nevertheless, the combination of measures described above should provide the standing emergency committee with the autonomy and capacity for credible, authoritative decision making. the un secretary general should create an accountability commission as an independent body comprised of civil society, academia, and independent experts doing realtime and retrospective system-wide assessment of global responses to major disease outbreaks. the accountability commission would track and analyse the contributions and results achieved by national governments, donors, un agencies, international and national nongovernmental organisations, and the private sector. all major actors would be expected to share information promptly with the accountability commission about fi nancial, in-kind, or operational contributions; the the accountability commission should publish the names of organisations unwilling to share such information. the accountability commission would assess aid eff ectiveness, including funds committed, paid, dis bursed, and spent; both short-term and long-term accomplishments achieved with those funds; and the timeliness, eff ectiveness, cultural appropriateness, and equity of the response for intended benefi ciaries. the accountability commission should liaise directly with and provide a forum for representatives of communities directly aff ected by outbreaks. finally, it should monitor eff orts to build and sustain national core capacities. the accountability commission would report to the world health assembly and the security council's global health committee (recommendation ), and publish its fi ndings regularly during and after each public health emergency of international concern. after an open call for nominations, the secretary general would appoint the fi rst members; thereafter, the accountability commission itself would periodically vote in new members to preserve its independent character. the accountability commission would off er an important multistakeholder platform for various constituencies involved in and aff ected by disease outbreak responses. this proposal builds on analogous eff orts to strengthen system-wide accountability for other global eff orts, such as the un commission on information and accountability for women's and children's health and the independent monitoring board of the global polio eradication initiative, credited with helping to reinvigorate the performance of this eff ort. the accountability commission would be a more permanent institution, however, with a broader mandate than these two previous initiatives. producing and rapidly sharing knowledge during outbreaks is essential. however, reliable systems for rapid transmission of epidemiological, genomic, and clinical data were not established during the ebola epidemic. although governments in the three worst aff ected countries transmitted epidemiological information to who, robust channels were not established for direct data exchange and coordination between the three capitals. although some researchers shared genomic sequencing data early in the outbreak through an open access database, other researchers later withheld such data from the public domain. and although care providers and researchers collected thousands of patient samples, now housed in laboratories in west africa and worldwide, no clear arrangements exist for scientists to access those samples, for their safe handling, or to ensure that west african patients benefi t from the fi ndings or technology that might result. previous epidemics show that better arrangements are feasible. during the sars outbreak, who established online systems for data sharing among a worldwide network of scientists, enabling researchers to identify the virus, sequence its genome, and understand its characteristics. in , an international consortium of researchers agreed to data sharing norms for infl uenza, which enabled real-time dissemination and publication of epidemiological and clinical data during h n in . the consortium for the standardization of infl uenza seroepidemiology helps to coordinate a global community of researchers working on infl uenza serology. furthermore, after years of intergovernmental negotiations, the who pandemic infl uenza preparedness framework achieved a delicate balance between sharing samples and access to the resulting technology. , however, no analogous framework exists for other pathogens. access to knowledge embodied in the form of technologies has been a particularly diffi cult issue. as noted, no drugs, vaccines, or rapid diagnostic tests had been approved for ebola when the outbreak began. although scientists had identifi ed the virus nearly four decades earlier and basic research had advanced understanding of the disease, ebola was not an attractive target for industry investment in research and development, nor was it high on the public health research agenda. somewhat serendipitously, the us and canadian governments had years earlier made defence-related investments in ebola, which meant that university and pharmaceutical industry researchers had developed several experimental drug and vaccine candidates when the outbreak hit. as noted, clinical trials for vaccines and drugs were launched in record time (with encouraging results for one vaccine candidate reported in july, ). nevertheless, the overall research and development eff ort could have moved faster if there had been investments beforehand to advance candidate products through phase or trials and a system to prioritise the most important technologies. for example, eff ective rapid point-of-care diagnostics could have enhanced contact tracing, counteracted community resistance and denial, protected health workers, reduced patient loss to follow-up, eased overburdened treatment centres, and supported the continued operation of shipping and airline services. a systematic way of posing and answering operational research questions, such as the relative merits of using intravenous fl uids for patient care, would also have strengthened the response. furthermore, who provided valuable technical leadership about the ethics of using unproven therapies, but little guidance on how strictly limited quantities of drugs should be rationed. west african health workers and patients were largely denied access to the stocks sometimes available to international staff . in several instances, who proved its capacity to lead, convene, coordinate, and establish norms among a broad range of public and private actors on research and development and data sharing. additionally to its guidance about experimental therapies, who convened research and development actors in mid- and late- , and again at a global ebola research and development summit in may, . in july, , who also issued guidance about accelerating regulatory approval of technologies in emergencies. who also convened a meeting in september, , to build norms for open data sharing as part of an eff ort to develop a "blueprint" to guide the collective research and development eff orts of industry and governments for emergencies. these successful eff orts should be institutionalised to better govern knowledge production and sharing in future outbreaks. before the world health assembly, who should convene governments, the scientifi c research community, industry and non-governmental organisations to begin developing a framework of norms and rules for research relevant to disease outbreaks. the framework's goal would be to provide guidance on three interrelated issues: . access to data and samples to enable and accelerate research, which would involve rapid sharing of epidemiological surveillance and clinical data to inform outbreak control strategies; incentives and platforms for open sharing and access to genomic sequencing data; access to specimen samples (with appropriate biosafety measures). . appropriate conduct of research, including improved ethical standards for research and development (eg, including involving aff ected populations in setting research priorities, patient participation and consent); previous agreement about experimental protocols, such as trial design, to speed clinical trials when outbreaks strike; access to clinical trial data, such as publication of negative and positive results; clear pathways for approval by stringent regulatory authorities and in countries of use; and building on and investing in research capacities in epidemicaff ected countries. . equitable access to the benefi ts of research, including priority, aff ordable access to newly developed health technologies for aff ected populations, including health workers; and ethical guidelines for rationing products with limited availability. an overarching framework is needed to bring coherence and fi ll gaps in the fragmented system of international rules shaping outbreak-related research (including the international health regulations, pandemic infl uenza preparedness framework, convention on biological diversity and its nagoya protocol, agreement on trade related aspects of intellectual property rights, and numerous guidelines and agreements for data ownership and sharing among scientists). the framework would include both nonbinding norms such as guidelines or codes of conduct, and binding rules such as contractual obligations or international law. further analysis is needed to specify the most appropriate instruments for each issue area. some norms would apply at all times to prepare for potential outbreaks; others could be limited to and triggered by a public health emergency of international concern declaration. establishment of such norms in advance would strengthen preparedness and reduce counter-productive competition between researchers or institutions during emergencies. ideally, such a normative framework would cover all pathogens with the potential to cause major outbreaks. however, in view of the complexity and political diffi culties reaching agreement on these issues, a feasible starting point might be to develop a pilot framework for one or several diseases such as viral haemorrhagic fevers. lessons from this pilot could subsequently be applied to expanding the framework to other pathogens. the accountability commission (recommendation ) should monitor progress towards developing this framework and subsequently monitor adherence to it. recommendation : establish a global facility to fi nance, accelerate, and prioritise research and development. the un secretary general and the who director-general should convene in a high-level summit of public, private, and not-for-profi t research funders to establish a global fi nancing facility for research and development for health technology relevant for major disease outbreaks. the facility would support manufacturing, research, and development for drugs, vaccines, diagnostics, and other non-pharmaceutical supplies (such as personal protective equipment) where the commercial market does not off er appropriate incentives. for known pathogens, the facility could invest in bringing candidate drugs, vaccines, technology platforms, and other relevant products through proof of concept, phase , and phase testing in humans, so that they are ready for wider testing, manufacturing, and distribution when an outbreak strikes. during an outbreak the facility would rapidly mobilise fi nance for priority research and development projects, such as diagnostics for novel pathogens. the establishment of a similar fund for diseases aff ecting developing countries was a central recommendation of the report of the who consultative expert working group on research and development. as a result, a pooled international fund was created to support "demonstration projects" that test new research and development business models, such as open knowledge innovation and delinkage of research and development fi nancing from end product prices. with a management structure already established, the demonstration projects off er an important option for pursuing research and development for ebola or other diseases. the global fi nancing facility should be a lean, effi cient entity that mobilises and strategically deploys resources. it would not be a monolithic entity nor the sole funder for epidemic-related research and development because some pluralism and competition among funders is desirable. nevertheless, a global facility would off er the advantage of enabling coordination between diff erent research funders through a common framework, strengthening networks between researchers, estab lishing processes for priority setting, and reducing transaction costs for both grantees and smaller donors. , it could also require information sharing between researchers as a condition of funding, thereby giving teeth to the data-sharing framework (recommendation ). intellectual property or any other asset resulting from these investments should be managed as a public good to enable follow-on innovation, open knowledge sharing, access to technology, and a fair public return on investment. support for a global research and development fi nancing mechanism now seems to be growing, as shown in calls for a $ billion global fund for vaccine development for pandemics, a $ billion global fund for antimicrobial resistance, and a $ - billion global fund that would cover emerging infectious diseases, neglected diseases, and antimicrobial resistance. an eff ective global system for preventing and responding to outbreaks needs well coordinated and appropriately resourced actors to fulfi l clearly defi ned roles and responsibilities and to hold each other accountable for doing so (table). many actors have crucial roles in this complex system: national governments have the main responsibility for their populations' health. national governments are also responsible for immediately sharing information with neighbouring countries and the international community in the event of a potential public health emergency of international concern. they also hold responsibility for calling for international assistance if domestic capabilities prove inadequate. in turn, international actors are responsible for supporting national governments individually and collectively. who should play a central part in monitoring, assessing, and responding to disease outbreaks. national and regional agencies for disease control and academies of science also off er important technical capacities for managing outbreaks. development banks are responsible for mobilising and disbursing fi nancing to support governments and collective action. the international humanitarian system, including the offi ce for the coordination of humanitarian aff airs, unicef, the world food programme, the un high commissioner for refugees, other un bodies, and non-governmental organisations are responsible for mounting an eff ective operational response if an outbreak escalates into a humanitarian crisis. the research community is responsible for producing relevant knowledge on the outbreak, and developing and producing technologies to intervene. civil society, including academia and the media, play a crucial part in drawing attention to unmet needs, neglected challenges, and systemic failings, and demanding accountability from responsible actors. finally, the un security council is responsible for addressing threats to international peace and security. ebola developed from a relatively small outbreak into a large-scale emergency because of the failures of multiple actors to fulfi l their mandated roles and responsibilities. our fi nal three recommendations outline the institutional changes needed to prevent such failures from recurring. in recognition of health as an essential facet of human and national security, the un security council should establish a global health committee consisting of government representatives. the com mittee's main goal would be to expedite and elevate political attention to health issues posing a serious risk to international peace and security and provide a prominent arena to mobilise political leadership. specifi cally, the committee would monitor and publish an annual report on progress in building a strong and eff ective global health security system, taking into account analyses from the accountability commission and who. the committee would also address alleged non-compliance with international health regulation provisions on trade and travel measures. the committee would not declare public health emergencies of international concern. this decision would remain technically driven and under the authority of who. the committee would not be able to strengthen core capacities within and between countries to prevent, detect, and respond to outbreaks support governments with technical and scientifi c knowledge and advice financing by major public and private donors; technical assistance by specialised agencies and non-governmental organisations mobilise external assistance when countries unable to prevent an outbreak from becoming a crisis raise awareness of major disease events; declare public health emergencies of international concern as appropriate; early-stage rapid response to outbreaks; convening for resource mobilisation who is an essential hub in the global system for health security. however, evidence of confusion and disagreement about its role is ample. since the th century, cross-border disease control was the fi rst and most widely accepted rationale for intergovernmental health cooperation. yet, in the wake of the global fi nancial crisis when who laid off more than a tenth of its headquarters staff , outbreak response capacity was deeply and disproportionately cut. disease outbreaks are not the only important work for who, but they are foundational to the organisation's mandate. within a global system for disease outbreak response, what should be who's essential role? who's near-universal state membership, governance structure, and deep relationships with health ministries situate it uniquely to perform four core functions (table): support governments in building national core capacities for prevention, surveillance, and response through technical and scientifi c knowledge and advice; assess and provide rapid early response to outbreaks, raise awareness of major disease events, and declare public health emergencies of international concern when appropriate; establish technical norms, standards and guidance; and convene actors to set goals, mobilise resources, resolve confl icts, and negotiate rules. performance of these functions needs strong political, scientifi c, and normative leadership with solid backing from member states. however, who's failings on these core functions during the ebola outbreak have now produced an existential crisis of confi dence. ebola exacerbated a trend since the s of many governments and other organisations working around who. decades of reducing assessed contributions in real terms has starved the organisation of resources. donors have earmarked voluntary contributions, eff ectively controlling nearly % of who's budget by . the result is an organisation that seems to have lost its way. although the budget has more than doubled from us$ · billion in - to us$ billion in - , the organisation itself controlled an ever-shrinking share. one casualty of recent decisions was who's reduced ability to control cross-border disease outbreaks, a core task for which it was created in . in the wake of ebola, the organisation's traditional claims of legitimacy based on near-universal state membership no longer seem suffi cient. a true recovery will need far greater willingness by member states to entrust resources and delegate authority to who, but it has rarely been in a weaker position to command such trust and authority. confi dence in the organisation's capacity to lead is at an all-time low. calling for additional staff or a larger budget will not address this. who must fi nd a way to prioritise what it does, and regain its credibility, independence, and legitimacy to perform its core functions (table) . breaking out of this -year impasse will demand clear commitment and a diff erent kind of leadership by who to implement fundamental reforms under a tight timeline, matched by an equally clear commitment by member states to reward such reform with appropriate authority and resources. who performed a key coordinating function in research and development during the ebola epidemic. it was also central to controlling nine previous ebola outbreaks, sars, and other epidemics. these examples are important reminders of what who can do under determined leadership. who is in a formal reform process that was spurred by a budget crisis in ; in some ways, it has been in a perennial process of reform since at least the s. these previous eff orts are a reminder that high-level political leadership, such as the engagement of heads of state, will be needed if the outcome is to be diff erent this time. at this point, anything less than fundamental reform will mean continued marginalisation and decline, alongside increasing vulnerability for global public health. to rebuild trust, respect, and confi dence within the international community, who should maintain its broad defi nition of health, but substantially scale back its expansive range of activities to focus on core functions. the scope of who's work would thus continue to embrace the full range of health issues, but its functions should be far more circumscribed. we restrict our analysis to core functions in infectious disease outbreaks. however, there remains the need to defi ne who's core functions in other key areas of work, such as non-communicable diseases, injuries, environmental health, health systems, and social determinants of health. for this purpose, the january executive board should launch a fundamental review of the organisation's constitution and mandate to defi ne its core functions. this review should identify and hand over non-core activities to other actors, thereby streamlining who's activities. it should also examine which core functions are not being fulfi lled or adequately funded. the fi nancing model for who is unstable and politically vulnerable. the january executive board should also begin developing a new fi nancing model for assessed contributions focused on core functions and draft a transparently implemented policy about when to accept or reject voluntary contributions at headquarters, regional, and country offi ces. if who strictly defi nes its core functions and accelerates other good governance reforms (recommendation ), member states should shift most of its fi nancing to assessed and non-earmarked voluntary contributions. recommendation : good governance of who through decisive, timebound reform, and assertive leadership. restoring credibility demands that who institutionalises accountability mechanisms, strengthens and clarifi es how it works with other actors, and fosters strong leadership. the january executive board should launch a process to implement four new policies for who to meet basic principles of good governance: establish a freedom of information policy, with appropriate safeguards; create a permanent inspector general's offi ce to monitor overall performance of the organisation and its entities, reporting to the executive board; conclude continuing work on the framework of engagement with non-state actors to better govern the way who interacts with civil society, academia, foundations, and the private sector; and revise human resource policies to attract or retain well qualifi ed staff , including for leadership positions, while letting go of chronic underperformers. the executive board should seize the short window of opportunity available for such reforms by giving a strong mandate to an interim deputy for managerial reform reporting to the director-general to implement these policies by july, (before the next director-general takes offi ce). in line with the reformed approach to human resources, all upcoming leadership selection and election processes at headquarters, regional, and country offi ces should be based on personal, technical, and leadership merits. the executive board, with the participation of civil society, should do an annual appraisal of senior leadership to strengthen accountability. as the next director-general election approaches, member states should insist on a dynamic leader with a strong record of focusing on people, able to manage crises, implement reforms, and communicate strategically. a key attribute should be proven high-level political leadership with the character and capacity to challenge even the most powerful governments when necessary to protect public health. it is in the collective interest of member states to have a strong, empowered leader heading the who. taken together, the panel's ten recommendations provide a vision for a more robust, resilient global system able to manage infectious disease outbreaks (panel , fi gure ). preventing small outbreaks from becoming large-scale emergencies demands investment in minimum capacities in all countries and encouragement of early international reporting of outbreaks by adhering to agreed international rules. responding eff ectively to outbreaks demands much stronger operational capacity within who and within the broader aid system if outbreaks escalate into humanitarian emergencies, a politically protected process for who's emergency declarations, and strong mechanisms for the accountability of all involved actors, from national governments to non-governmental organisations and from un agencies to the private sector. mobilisation of the knowledge needed to combat outbreaks will require an international framework of rules to enable, govern, and ensure access to the benefi ts of research, and fi nancing to develop technology when commercial incentives are inappropriate. finally, eff ective governance of this complex global system demands high-level political leadership and a who that is more focused and appropriately fi nanced and whose credibility is restored through the implementation of good governance reforms and assertive leadership. the human catastrophe of the ebola epidemic that began in shocked the world's conscience and created an unprecedented crisis. it exposed deep inadequacies in the national and international institutions responsible for protecting the public from the far-reaching human, social, economic and political consequences of disease outbreaks. the reputation and credibility of who has suff ered a particularly fi erce blow. ebola brought to the forefront a central question: is major reform of international institutions feasible to restore confi dence and prevent future catastrophes? or should leaders conclude the system is beyond repair and take ad hoc measures when the next major outbreak strikes? research: producing and sharing data, knowledge, and technology . develop a framework of rules to enable, govern, and ensure access to the benefi ts of research . establish a global facility to fi nance, accelerate, and prioritise research and development governing the global system . sustain high-level political attention through a global health committee of the security council . a new deal for a more focused, appropriately fi nanced who . good governance of who through decisive, time bound reform and assertive leadership international health regulation emergency committee. the standing emergency committee will meet and receive information from the emergency centre regularly, with the mandate to declare a public health emergency of international concern by a majority vote of its members. the director-general would chair this committee. a permanent inspector general's offi ce is proposed, along with other good governance reforms (not depicted in the fi gure) such as a freedom of information policy. after diffi cult and lengthy deliberation, our panel concluded major reforms are warranted and feasible. the panel refi ned its recommendations into a roadmap of ten interrelated reforms that in combination can strengthen the global system for outbreak prevention and response. the roadmap gives greatest weight to clarifi cation of the roles and responsibilities of the many actors involved in outbreak response, investing in capacities to fulfi l those roles, and demanding accountability for meeting those responsibilities. these measures are concrete, actionable, and measurable. success requires one other essential ingredient: high-level political leadership determined to translate this roadmap into enduring systemic reform so that the immense human suff ering of the ebola outbreak will not be repeated. msf addresses un security council emergency session on ebola ebola situation reports un offi ce of the special envoy on ebola. resources for results iii appeal: ebola virus outbreak-overview of needs and requirements (inter-agency plan for guinea global health security: the wider lessons from the west african ebola virus disease epidemic governance challenges in global health the next epidemic-lessons from ebola preparing for the next outbreak report of the review committee on the functioning of the international health regulations ( ) in relation to pandemic (h n ) ground zero in guinea: the outbreak smouldersundetected-for more than months pushed to the limit and beyond: a year into the largest ever ebola outbreak inside the troubled early days of guinea's ebola response emails: un health agency resisted declaring ebola emergency who says guinea ebola outbreak small as msf slams international response ebola's lessons: how the who mishandled the crisis doctors without borders canada/médecins sans frontières (msf) canada. ebola in west africa: "the epidemic is out of control investigation: bungling by un agency hurt ebola response ahf: failed global ebola response demands new leadership ebola: world bank group mobilizes emergency funding to fi ght epidemic in west africa why we fail at stopping outbreaks like ebola yale global health justice partnership and american civil liberties union. fear, politics, and ebola how quarantines hurt the fight against ebola and violate the constitution. connecticut: yale global health justice partnership who. statement on the st meeting of the ihr emergency committee on the ebola outbreak in west africa liberia's military tries to remedy tension over ebola quarantine. monrovia: the new york times with spread of ebola outpacing response, security council adopts resolution ( ) urging immediate action, end to isolation of aff ected states special representative of the un secretary general arrives in accra to establish the un mission for ebola emergency response headquarters ethical considerations for use of unregistered interventions for ebola virus disease ebola: the failures of the international outbreak response international donations to the ebola virus outbreak: too little, too late? as ebola rages, poor planning thwarts eff orts community-centered responses to ebola in urban liberia: the view from below we are dying of ebola; where is the world? africa review disease outbreak: finish the fi ght against ebola importation and containment of ebola virus disease-senegal and the centers for disease control and prevention (cdc) when losing track means losing lives: accountability lessons from the ebola crisis who. ebola r&d eff ort-vaccines, therapeutics, diagnostics who. ebola situation report- how cuba could stop the next ebola outbreak responding to health emergencies ebola: towards an international health systems fund overseeing global health implementation of the international health regulations ( )-report of the review committee on second extensions for establishing national public health capacities on ihr implementation. geneva: world health organization who. statement on the nd meeting of the ihr emergency committee regarding the ebola outbreak in west africa statement on the rd meeting of the ihr emergency committee regarding the ebola outbreak in west africa. geneva: world health organization who. statement on the th meeting of the ihr emergency committee regarding the ebola outbreak in west africa statement on the th meeting of the ihr emergency committee regarding the ebola outbreak in west africa. geneva: world health organization the white house offi ce of the press secretary uniting in seoul to extinguish epidemic threats through the global health security agenda leaders declaration international ebola recovery conference world bank group provides new fi nancing to help guinea, liberia and sierra leone recover from ebola emergency the bill & melinda gates foundation to fund disease surveillance network in africa and asia to prevent childhood mortality and help prepare for the next epidemic train africa's scientists in crisis response clinical laboratory networks contribute to strengthening disease surveillance: the resaolab project in west africa fleming fund launched to tackle global problem of drug-resistant infection a wake up call: lessons from ebola for the world's health systems the ebola review: parts i and ii who criticizes china over handling of mystery disease. hong kong: the new york times african risk capacity insurance mechanism report of the ebola interim assessment panel ebola virus disease epidemic in west africa: lessons learned and issues arising from west african countries saving lives: the civil-military response to the ebola outbreak in west africa ebola virus outbreak -overview of needs and requirements (inter-agency plan for guinea inter-agency standing committee working group. humanitarian system-wide emergency activation: defi nitions and procedures commission on information and accountability for women's and children's health. keeping promises, measuring results the power of straight talk: the independent monitoring board of the global polio eradication initiative data sharing: make outbreak research open access ebola researchers plead for access to virus samples proposed ebola biobank would strengthen african science sars: a global response to an international threat a global initiative on sharing avian fl u data infl uenza preparedness framework advisory group technical expert working group on genetic sequence data the who pandemic infl uenza preparedness framework: a milestone in global governance for health effi cacy and eff ectiveness of an rvsv-vectored vaccine expressing ebola surface glycoprotein: interim results from the guinea ring vaccination cluster-randomised trial opting against ebola drug for ill african doctor who consultative expert working group on research and development. research and development to meet health needs in developing countries: strengthening global fi nancing and coordination establishing a global vaccine-development fund demonstration fi nancing: considerations for the new international fund for r&d securing new drugs for future generations: the pipeline of antibiotics a global biomedical r&d fund and mechanism for innovations of public health importance what's the world health organization for?: fi nal report from the centre on global health security working group on health governance the world health organization. abingdon: routledge cuts at w.h.o. hurt response to ebola crisis who. proposed programme budget all authors contributed to study concept, data analysis and interpretation, and provided critical revisions of the manuscript for important intellectual content. pp, akj, map, and ds chaired and co-chaired the panel, respectively, providing high level content and directional oversight. sm supervised the study design, data collection, data analysis, and data interpretation; drafted the manuscript; and led all revisions. bh, jal, and lrw contributed to the data collection, data analysis and data interpretation; creation of fi gures; and provided administrative, technical, and material support. we thank julio frenk for initial discussions that led to the creation of the panel, and robert marten and the rockefeller foundation for supporting the london meeting of the panel, and research and dissemination eff orts. we are grateful to emily anne robinson for research and organisational support for the boston meeting, and to zoe mark lyon for research support. key: cord- - hphhx authors: dong, lu; bouey, jennifer title: public mental health crisis during covid- pandemic, china date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: hphhx the novel coronavirus disease emerged in china in late –early and spread rapidly. china has been implementing emergency psychological crisis interventions to reduce the negative psychosocial impact on public mental health, but challenges exist. public mental health interventions should be formally integrated into public health preparedness and emergency response plans. lu dong, jennifer bouey ( ) . covid- is more transmissible than sars, and the case-fatality rate ( . %) is substantially higher than that for seasonal influenza ( ) . the uncertain incubation period of the virus and its possible asymptomatic transmission cause additional fear and anxiety. second, the government's initial downplaying of the epidemic's severity eroded public trust in the government's decision-making transparency and competency. third, unprecedented large-scale quarantine measures in all major cities, which essentially confine residents to their homes, are likely to have a negative psychosocial effect on residents ( ). fourth, reports of shortages of medical protective supplies, medical staff, and hospital beds in wuhan and the surrounding areas soon followed the citywide quarantine and caused enormous concern throughout the nation. last, a unique "infodemic"an overabundance of (mis)information on social media ( ) and elsewhere-poses a major risk to public mental health during this health crisis. as during the sars and ebola virus disease outbreaks, generalized fear and fear-induced overreactive behavior were common among the public; both can impede infection control ( , ) . in addition, psychiatric disorders, such as depression, anxiety, and posttraumatic stress disorder, developed in high-risk persons, especially survivors and frontline healthcare workers ( ). on the basis of these recent experiences, the national health commission of china released a notification on january , , providing guiding principles of the emergency psychological crisis interventions to reduce the psychosocial effects of the covid- outbreak ( ) . this notification specified that psychological crisis intervention should be part of the public health response to the covid- outbreak, organized by the joint prevention and control mechanism at the city, municipal, and provincial levels, and that the interventions should be differentiated by group. the intervention workforce comprises psychological outreach teams led by psychiatrists and mental health professionals and psychological support hotline teams. an attachment to this notification further outlined the key intervention targets for groups: confirmed patients, persons under investigation for covid- , healthcare workers, persons in immediate contact with patients, ill persons who refuse to seek care, and susceptible persons/the general public (appendix, https://wwwnc.cdc.gov/eid/ article/ / / - -app .pdf). the release of such policy guidance acknowledges china's recognition of public mental health needs during the outbreak. however, the notification does not specify how different resources should be mobilized and coordinated or, more important, who should deliver which type of interventions, for which group in need, and by which delivery mode(s). the policy guidance also does not indicate operationalization of how various groups should be screened or assessed to determine the type and level of interventions to provide to each. this level of detail is needed because china lacks a well-established mental healthcare system and has no existing national-level emergency response system and designated workforce to provide the psychological crisis interventions during a national emergency or disaster (x. chen, x. fu, unpub. data, https:// doi.org/ . /j.issn. - . ) ( ) . other major challenges to successfully implementing the emergency psychological crisis interventions include china's severe shortage of mental healthcare providers ( . psychiatrists/ , population, and only half of these psychiatrists have attained a bachelor's degree in medicine), unevenly distributed healthcare resources, and the limitations posed by the mass quarantine ( ) . for example, hospitals, universities, and a variety of organizations have set up numerous hotlines staffed by volunteers with varying degrees of qualification and experience ( ) . these well-meaning efforts can be uncoordinated and inadequately supervised and thus are likely to cause confusion to service consumers and inefficient use of resources. the challenges reported in china indicate that, for many developing countries, telemedicine should be considered, given the widespread adoption of smartphones, to help remove barriers to accessing quality care for mental health. task-shifting or -sharing (i.e., shifting service delivery of specific tasks from professionals to persons with fewer qualifications or creating a new cadre of providers with specific training) might help, especially in low-resource areas ( ) . countries should also consider requesting support and guidance from global mental healthcare authorities and research communities through international collaborations. given lessons learned from past outbreaks in china and other parts of the world, public mental health interventions should be formally integrated into public health preparedness and emergency response plans to effectively curb all outbreaks. the world health organization's strategic preparedness and response plan for covid- , however, has not yet specified any strategies to address mental health needs of any kind ( ). as the virus spreads globally, governments must address public mental health needs by developing and implementing well-coordinated strategic plans to meet these needs during the covid- pandemic. dr. dong is an associate behavioral scientist and a licensed clinical psychologist at rand corporation. her primary research interests are development and improvement of evidence-based psychosocial interventions for youth and adults. dr. bouey is a senior policy researcher and the tang chair in china policy studies at rand corporation and an associate professor of global health at georgetown university. her primary research interests include the social determinants of health among underserved populations. rapid identification of mycobacteria to the species level by polymerase chain reaction and restriction enzyme analysis mycobacterium avium subsp. hominissuis infection in a domestic rabbit novel insights into transmission routes of mycobacterium avium in pigs and possible implications for human health mycobacterium avium-triggered diseases: pathogenomics infection sources of a common non-tuberculous mycobacterial pathogen, mycobacterium avium complex from sars to -coronavirus (ncov): u.s.-china collaborations on pandemic response: addendum the novel coronavirus pneumonia emergency response epidemiology team. the epidemiological characteristics of an outbreak of novel coronavirus diseases (covid- )-china the psychological impact of quarantine and how to reduce it: rapid review of the evidence novel coronavirus ( -ncov): strategic preparedness and response plan the role of fear-related behaviors in the - west africa ebola virus disease outbreak national center for infectious diseases/sars community outreach team. fear and stigma: the epidemic within the sars outbreak long-term psychiatric morbidities among sars survivors national health commission of china. principles of the emergency psychological crisis interventions for the new coronavirus pneumonia integrated mental health services in china: challenges and planning for the future joint who/ogac technical consultation on task shifting: key elements of a regulatory framework in support of in-country implementation of task shifting. geneva: the organization address for correspondence: lu dong, rand corporation department of infectious diseases, union hospital, tongji medical college we report rhabdomyolysis related to covid- in wuhan, china. a -year-old man in wuhan sought care in february for a -day history of fever up to . °c and cough. chest computed tomography performed days before in another hospital showed that the texture of both lungs was thickened and scattered with ground glass shadows (appendix figure results were in the normal range for creatine kinase (ck) and indicators of hepatic and kidney function. screenings for common infectious diseases were negative. real-time reverse-transcription pcr analysis of the patient's throat swab specimen indicated sars-cov- infection we describe a patient in wuhan, china, with severe acute respiratory syndrome coronavirus infection who had progressive pulmonary lesions and rhabdomyolysis with manifestations of lower limb pain and fatigue. rapid clinical recognition of rhabdomyolysis symptoms in patients with severe acute respiratory syndrome coronavirus infection can be lifesaving. key: cord- -kk iyavj authors: muller, researcher ashley elizabeth; hafstad, senior advisor elisabet vivianne; himmels, senior advisor jan peter william; smedslund, senior researcher geir; flottorp, research director signe; stensland, researcher synne Øien; stroobants, scientific coordinator stijn; van de velde, researcher stijn; elisabeth vist, senior researcher gunn title: the mental health impact of the covid- pandemic on healthcare workers, and interventions to help them: a rapid systematic review date: - - journal: psychiatry res doi: . /j.psychres. . sha: doc_id: cord_uid: kk iyavj the covid- pandemic has heavily burdened healthcare systems throughout the world. we performed a rapid systematic review to identify, assess and summarize research on the mental health impact of the covid- pandemic on hcws (healthcare workers). we utilized the norwegian institute of public health's live map of covid- evidence on may and included studies. six reported on implementing interventions, but none reported on effects of the interventions. hcws reported low interest in professional help, and greater reliance on social support and contact. exposure to covid- was the most commonly reported correlate of mental health problems, followed by female gender, and worry about infection or about infecting others. social support correlated with less mental health problems. hcws reported anxiety, depression, sleep problems, and distress during the covid- pandemic. we assessed the certainty of the estimates of prevalence of these symptoms as very low using grade. most studies did not report comparative data on mental health symptoms before the pandemic or in the general population. there seems to be a mismatch between risk factors for adverse mental health outcomes among hcws in the current pandemic, their needs and preferences, and the individual psychopathology focus of current interventions. the covid- pandemic has heavily burdened, and in many cases overwhelmed, healthcare systems , including healthcare workers. the who emphasized the extremely high burden on healthcare workers, and called for action to address the immediate needs and measures needed to save lives and prevent a serious impact on physical and mental health of healthcare workers . previous viral outbreaks have shown that frontline and non-frontline healthcare workers are at increased risk of infection and other adverse physical health outcomes . furthermore, healthcare workers reported mental health problems putatively associated with' occupational activities during and up until years after epidemics, including symptoms of post-traumatic stress, burnout, depression and anxiety [ ] [ ] [ ] . likewise, reports of the mental toll on healthcare workers have persistently appeared during the current global health crisis [ ] [ ] [ ] . several reviews have already been conducted on healthcare workers' mental health in the covid- pandemic, with search dates up to may . pappa et al. identified thirteen studies in a search on april and pooled prevalence rates; they reported that more than one of every five healthcare workers suffered from anxiety and/or depression; nearly two in five reported insomnia. vindegaard & benros' review, searching on may , identified twenty studies of healthcare workers in a subgroup analysis, and their narrative summary concluded that healthcare workers generally reported more anxiety, depression, and sleep problems compared with the general population. in the face of a prolonged crisis such as the pandemic, sustainability of the healthcare response fully relies on its ability to safeguard the health of responders: the healthcare workers , . yet, the recent findings of psychological distress among healthcare workers might indicate that the healthcare system is currently unable to effectively help the helpers. understanding the risks and mental health impact(s) that healthcare workers experience, and identifying possible interventions to address adverse effects, is invaluable. our main aim was to perform an updated and more comprehensive rapid systematic review to identify, assess and summarize available research on the mental health impact of the covid- pandemic on healthcare workers, including a) changes over time, b) prevalence of mental health problems and risk/resilience factors, c) strategies and resources used by healthcare providers to protect their own mental health, d) perceived need and preferences for interventions, and e) healthcare workers' understandings of their own mental health during the pandemic. our second aim was to describe the interventions assessed in the literature to prevent or reduce negative mental health impacts on healthcare workers who are at work during the covid- pandemic. we conducted a rapid systematic review according to the methods specified in our protocol, published on our institution's website . we included any type of study about any type of healthcare worker during the covid- pandemic, with outcomes relating to their mental health. we extracted information about interventions aimed at preventing or reducing negative mental health impacts on healthcare workers; we were therefore interested in quantitative studies examining prevalence of problems and effects of interventions as well as qualitative studies examining experiences. we had no restrictions related to study design, methodological quality, or language. we identified relevant studies by searching the norwegian institute of public health's (niph's) live map of covid- evidence (https://www.fhi.no/en/qk/systematic-reviews-hta/map/) and database on may , as described in our protocol . the live map and database contained , references screened for covid- relevance containing primary, secondary, or modelled data. two researchers independently categorized these references according to topic (seven main topics, subordinate topics), population ( available groups), study design, and publication type. we identified references categorized to the population "healthcare workers", and to the topic "experiences and perceptions, consequences; social, political, economic aspects". in addition, we identified references by searching (title/abstract) in the live map's database, using the keywords: emo*, psych*, stress*, anx*, depr*, mental*, sleep, worry, somatoform, and somatic symptom disorder. we screened all identified references specifically for the inclusion criteria for this systematic review. the protocol of the live map of covid- evidence describes the methodology of the map and database the last included search for this review was conducted on may . the search strategy is presented in appendix . we developed a data extraction form to collect data on country and setting, participants, exposure to covid- , intervention if relevant, and outcomes related to mental health. we extracted data on prevalence of mental health problems as well as correlates (i.e. risk/resilience factors); strategies implemented or accessed by healthcare worker to address their own mental health; perceived need and preferences related to interventions aimed at preventing or reducing negative mental health consequences; and experience and understandings of mental health and related interventions. one researcher (aem) extracted data and another checked her extraction. two researchers (aem, sf/gev) independently assessed the methodological quality of systematic reviews using the amstar tool and of qualitative studies using the casp checklist . one researcher (aem) assessed the quality of cross-sectional studies using either the jbi prevalence or the jbi cross-sectional analytical checklist, and longitudinal studies using the jibi cohort checklist . results of these checklists are presented in appendix in the standard risk of bias format. we summarized outcomes narratively. we describe interventions and outcomes based on the information provided in the studies. when studies presented prevalence rates out mental health outcomes in figures without numbers, we extracted numbers using an online software (https://apps.automeris.io/wpd/). we presented mean prevalence rates as box-and-whisker plots. we decided not to perform a quantitative summary of the associations between the various correlates and mental health factors, due to a combination of heterogeneity in assessment measures and lack of control groups, and an overarching lack of descriptions necessary to confirm sufficient homogeneity. our included studies not only varied greatly from one another, they most often did not report sufficient information regarding inclusion criteria, population, setting, and exposure to assess potential clinical heterogeneity. we graded the certainty of the evidence using the grade approach (grading of recommendations assessment, development, and evaluation . fifty-nine studies were included. table displays their summarized characteristics, while appendix displays characteristics of the individual studies. a total of , participants were drawn from at least separate countries across the studies (one study reported participants came from countries, but did not specify these). the people's republic of china was the single most common setting ( studies and , participants), followed by iran (four studies). setting was not applicable for the two systematic reviews and the review of online mental health surveys. the majority of studies ( ) were cross-sectional surveys; two studies reported surveys administered twice over time; five were interview studies, of which three were analyzed qualitatively and two quantitatively; and four were other designs, including a case series and a study that searched within a database of existing online surveys. we also identified two systematic reviews , , which included five primary studies , , , , . the studies reported on healthcare workers working in different settings: studies reported on health care workers in hospitals, two studies were conducted in specialist health services outside hospitals, and three studies in other settings, while studies did not specify the healthcare setting or only partially described multiple settings. no studies reported on nursing homes or primary care settings. in studies, participants were frontline workers, while studies reported on non-frontline workers. frontline or non-frontline activities were unclear in ten studies. six studies reported on interventions to reduce mental health problems. more than half of the studies included nurses ( ) and/or doctors ( ) . study sizes ranged from a case study with three participants to a survey of , participants. six studies reported on the implementation of interventions to prevent or reduce mental health problems caused by the covid- pandemic among healthcare workers. these interventions can be loosely divided into those targeting organizational structures, those facilitating team/collegial support, and those addressing individual complaints or strategies. two interventions involved organizational adjustments. the first intervention was reported on by two studies , . hong et al. called it a "comprehensive psychological intervention" for frontline workers undergoing a mandatory two-week quarantine in a vocational resort, following two-to three-week hospital shifts. the quarantine itself was also described as part of the intervention, explicitly intended "to alleviate worries about the health of one's family". other elements included shortened shifts; involvement of the labor union to provide support to healthcare workers' families; and a telephone-based hotline that allowed healthcare workers to speak to trained psychiatrists or psychologists. this hotline had already been available to healthcare workers for four hours per week prior to the pandemic, but was made available for twelve hours, seven days a week. chen et al. reported a second intervention that attempted to address individual complaints and facilitate collegial support. a telephone hotline was set up to provide immediate psychological support, along with a medical team that provided online courses to help healthcare workers handle psychological problems, and group-based activities to release stress. however, uptake was low, and when researchers conducted interviews with the healthcare workers to understand this, healthcare workers reported needing personal protective equipment and rest, not time with a psychologist. they also requested help addressing their patients' psychological distress. in response, the hospital developed more guidance on personal protective equipment, provided a rest space, and provided training on how to address patients' distress. schulte et al. targeted collegial support and building individual strategies through one-hour video "support calls" for healthcare workers called in from their homes, to describe the impact of the pandemic on their lives, to reflect on their strengths, and to brainstorm coping strategies. this intervention was implemented as a response to the hospital redeploying pediatric staff to work as covid- frontline staff, and reorganizing pediatric space to accommodate more pediatric and adult covid- patients. none of the studies that implemented mental health interventions reported on the effects of the interventions on healthcare workers. the only data available to approximate the impact of the pandemic on the mental health of healthcare workers come from two longitudinal survey studies reporting on changes over time, both of low methodological quality. lv et al. surveyed healthcare workers before and during the outbreak, reporting no further information about the timeline. the study included both those working on the frontline and those with unclear exposure to covid- . however, it is unclear whether respondents were the same at both time points. the prevalence of anxiety, depression, and insomnia increased over time, whether mild, moderate, moderate to severe, or severe (see figure ). during the outbreak, one out of every four healthcare workers reported at least mild anxiety, depression, or insomnia. ***insert figure about here *** yuan et al. and an increase in smoking and drinking for only %. the proportion reporting improvement was similar for fidgeting, fear, and feeling nervous and uneasy, and more improved in not thinking one can succeed and for a reduction in smoking and drinking. two cross-sectional studies reported healthcare workers' self-reported changes in mental health; both were also of low methodological quality due to insufficient reporting. in benham et al. , twelve iranian psychiatry residents were re-deployed to work one frontline shift. half of the residents reported that they experienced more distress after this shift. abdessater et al. , studied urology residents not working on the frontline. when asked to report the level of stress caused by covid- , % reported a medium to high amount of stress, and the remaining reported none to low. less than % had initiated a psychiatric treatment during the pandemic. a third cross-sectional study , also of low methodological quality, surveyed healthcare workers in china in february, during the "outbreak period". a different cohort of healthcare workers were surveyed in march, during the "non-epidemic outbreak period". the healthcare workers in to the second phase of the survey reported less symptoms of anxiety and depression, and higher health-related quality of life. twenty-nine studies reported prevalence data of mental health variables as proportions or percentages. (seventeen additional studies reported data as average scores on various instruments, and we did not extract this data.) we present box-and-whisker plots in figure to show the distribution of anxiety, depression, distress, and sleeping problems among the healthcare workers investigated in the studies, using the authors' own methods of assessing these outcomes the most commonly reported protective factor associated with reduced risk of mental health problems was having social support , , , . two studies directly measured self-perceived resilience. bohlken et al. asked their sample of psychiatrists and neurologists to assess how resilient they were on a likert scale from - ("not applicable" to "completely applicable"), and % selected the two highest categories. cai et al. compared experienced frontline workers with inexperienced frontline workers, and found that inexperienced workers scored lower on total resilience on the connor-david resilience scale as well as within each of three subscales, and had more mental health symptoms. inexperienced workers were also younger and had less social support available to them. ten studies reported that healthcare workers utilized other resources or had individual strategies to address their own mental health during the pandemic, separate from formal interventions. six studies reported that healthcare workers utilized support from family/friends during the pandemic. "family" was the most common stress coping mechanism utilized by louie et al. kang et al. found slightly higher levels of interest in professional resources. when asked from whom they prefer to receive "psychological care" or "resources", % answered psychologists or psychiatrists, % answered family or relatives, % answered friends or colleagues, % answered others, and % said they did not need help. the authors found that the preferred sources of psychological resources were related to the level of psychological distress. in a structural equation model that uncovered clusters of healthcare workers with different distress levels (subthreshold, mild, moderate, and severe), those with moderate and severe distress more often preferred to receive care from psychologists or psychiatrists, while those with subthreshold and mild distress more often preferred to seek care from family or relatives. in two studies, participants specified that they had a greater need for personal protective equipment than for psychological help. chung et al. reported this in a survey that allowed healthcare workers to describe their needs and concerns in free text and to request contact with a psychiatric nurse. while % requested such contact, nearly half of those who answered the free text question about their psychiatric needs wrote that they needed personal protective equpiment instead, and % said they were worried about infection. chen et al.'s study was to understand why uptake of their psychological intervention was so low, and findings were identical to chung et al.'s: "many staff mentioned that they did not need a psychologist, but needed more rest without interruption and enough protective supplies" (p. e ). only one study explored how healthcare workers would be willing to provide mental health services to other healthcare workers: twelve psychiatry residents were re-deployed as frontline workers for one shift in benham et al.'s study. after that shift, none were willing to provide face-to-face mental health services to other healthcare workers, although % said they would provide online services. they identified healthcare workers of deceased patients as possible target populations for online services. three qualitative studies assessed as valuable were included. two interconnected themes across all three studies were distress stemming both from concern for infecting family members, and from being aware of family members' concern for the healthcare workers. wu et al. explored reasons for stress during interviews with healthcare workers at a psychiatric hospital. while these healthcare workers were not on the frontline, they felt they were at higher risk of exposure than healthcare workers at a general hospital. their wards were crowded, and several patients were admitted from emergency rooms with aggressive behaviors that made social distancing difficult or that posed direct challenges to healthcare workers' use of personal protective equipment (such as tearing masks). healthcare workers felt unprepared because psychiatric hospitals had no plans in place. at the same time, they also felt that their peers on the frontline were providing more valuable care. an additional source of stress was knowledge of their own risk of infection and transmission to family members, particular to elderly parents in their care, and to children who were at home and whose schoolwork had to additionally be managed. the disruption of the pandemic to nurses' personal lives and career plans was another stressor. sun et al. concern was great enough that several respondents did not tell their family they were working on the frontline, while others did not live at home during this period. as with wu et al.'s nonfrontline workers, these healthcare workers also reported fear and anxiety of a new infectious disease that they felt unprepared to handle on a hospital-level, unprepared to treat on a patientlevel, and from which they were unable to protect themselves. the first week of training and the first week of actual frontline work was characterized by these negative emotions, which were then joinednot necessarily replacedby more positive emotions such as pride at being a frontline nurse, confidence in the hospital's capacity, and recognition by the hospital. yin et al. families, particularly because their families would suffer more financially from needing to be quarantined than they already were suffering under the lockdown; fears of using personal protective equipment incorrectly; and feeling unequipped to handle patients' non-medical needs. healthcare workers reported that stigma suppressed patients' provision of accurate travel and quarantine history. this was an issue they were ill-equipped to help patients address when they returned to the community. healthcare workers also reported that they were stigmatized, because they were potential sources of infection. this systematic review identified heterogeneous studiesincluding three qualitative, fifty quantitative, two narrative reviews, and four other designsthat examined the mental health of between one and two of every five healthcare worker reported anxiety, depression, distress, and/or sleep problems. only one study reported on somatic symptoms such as changes in appetite. our confidence in these broad estimates, assessed using grade, was very low, which leads us to caution that the true prevalence of anxiety, depression, distress, and sleep problems among healthcare workers are likely different than our estimates. at the same time, is also common in interventions for healthcare worker burn-out before the pandemic . the most striking illustration of this was the finding shared by two studies , that healthcare workers said personal protective equipment would benefit their mental health more than professional help. on the other hand, it is possible that healthcare workers could benefit from professional mental health interventions more than they recognize or report, and that under-recognition is related to occupational culture, or fear of stigma or being perceived as weak . while a variety of countries were represented, four of every five participants were chinese, and chinese occupational culture may be a salient mediator of healthcare workers' expressed preferences , although this must be explored further. health's rigorous methodological standards for systematic reviews, such as two researchers screening and assessing eligibility. an additional methodological strength is our utilization of the live map of covid- evidence, one of the first reviews to do so (see also two reports , and one diagnostic accuracy study ). by using our map, we quickly identified studies that had already been categorized to our topic and population of interest, without having to search in academic databases and screen again. while not being able to conduct a meta-analysis is unfortunate, it was appropriate not to assume that poorly reported studies were homogenous enough. the principle of homogeneity tends to be overlooked by systematic reviewers eager to produce a summary estimate, but if met, means that all studies included were similar enough that their participants can be considered participants of one large study . the result, however, is that the prevalence data about mental health problems does not provide a summary estimate that can be generalized. other weaknesses are those common to rapid reviews due to time pressure, such as fewer details about the included studies' populations being presented than normally reported. the covid- pandemic has resulted in a flood of studies, many of which have been pushed through the peer-review process and published at speeds hitherto unseen (see glasziou for a discussion). it is therefore not surprising that the majority of our included studies were assessed as having a high risk of bias or being of low methodological quality. lack of information on samples or procedures was a common limitation, leading to serious implications to the generalizability and validity of findings. we also call on journals and researchers to balance the need for rapid publication with properly conducted studies, reviews and guidelines . healthcare workers in a variety of fields, positions, and exposure risks are reporting anxiety, depression, distress, and sleep problems during the covid- pandemic. causes vary, but for those on the frontline in particular, a lack of opportunity to adequately rest and sleep is likely related to extremely high burdens of work, and a lack of personal protective equipment or training may exacerbate mental health impacts. provision of appropriate personal protective equipment and work rotation schedules to enable adequate rest in the face of long-lasting disasters such as the covid- pandemic seem paramount. over time, many more healthcare workers may struggle with mental health and somatic complaints. the six studies exploring mental health interventions 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plos one doi: . /journal.pone. sha: doc_id: cord_uid: nljd ok purpose: to examine the psychological impact of fertility treatment suspensions resulting from the covid- pandemic and to clarify psychosocial predictors of better or worse mental health. methods: women from canada and the united states (ages – years) whose fertility treatments had been cancelled were recruited via social media. participants completed a battery of questionnaires assessing depressive symptoms, perceived mental health impact, and change in quality of life related to treatment suspensions. potential predictors of psychological outcomes were also examined, including several personality traits, aspects of social support, illness cognitions, and coping strategies. results: % of respondents endorsed clinical levels of depressive symptoms. on a -point scale, participants endorsed a significant decline in overall quality of life (m(sd) = - . ( . ), p < . ) as well as a significant decline in mental health related to treatment suspensions on a scale from - to + (m(sd) = - . ( . ), p < . ). several psychosocial variables were found to positively influence these outcomes: lower levels of defensive pessimism (r = -. , p < . ), greater infertility acceptance (r = . , p < . ), better quality social support (r = . , p < . ), more social support seeking (r = . , p < . ) and less avoidance of infertility reminders (r = -. , p = . ). conclusion: fertility treatment suspensions have had a considerable negative impact on women’s mental health and quality of life. however, these findings point to several protective psychosocial factors that can be fostered in the future to help women cope. one in six reproductive-aged couples experience infertility, defined as being unable to achieve pregnancy despite � months of focused attempts to conceive [ ] . although male and female-factor infertility are equally prevalent, women generally bear the brunt of infertilityrelated burden: even in cases of male-factor infertility, treatments such as intrauterine insemination (iui) or in vitro fertilization (ivf) require that women attend near-daily ultrasounds, self-inject gonadotropins, and undergo invasive and painful procedures. women also carry a disproportionate share of the psychological burden associated with infertility, with infertile women consistently reporting lower self-esteem, more depression and anxiety, and lower life satisfaction, than their male partners [ ] . studies of women presenting for the evaluation of infertility in a tertiary care setting suggest that approximately - % of these women experience clinically significant depression or anxiety [ ] [ ] [ ] [ ] . in fact, quality of life and levels of depression and anxiety among women undergoing fertility treatments are indistinguishable from those of individuals undergoing cancer treatments and cardiac rehab following a heart attack [ ] . on march th , , the american society of reproductive medicine and the canadian fertility and andrology society announced their recommendations to immediately suspend all in-person fertility treatments throughout canada and the u.s. indefinitely due to the covid- pandemic [ , ] . these recommendations included delaying the start of new treatment cycles but also, in many cases, abandoning treatment cycles that had already begun. while perhaps the right decision given the circumstances, this was devastating news for thousands of couples: unsurprisingly, one early survey of patients at a new york city fertility clinic found that % of patients reported being "very" to "extremely" upset over the cancellation of fertility cycles [ ] . however, to our knowledge, there have been no studies examining the mental health impacts of fertility treatment suspensions. this was therefore the purpose of the current investigation. furthermore, the current study aimed to clarify predictors of better or worse mental health during this challenging time. women from across canada and the united states were recruited to participate in the current online study via advertising on social media. to qualify, women had to report having had their fertility treatments suspended due to the covid- pandemic and that their treatments had not yet resumed. individuals were compensated with a $ . amazon e-gift card for their participation. the consent form for this study consisted of the first page of the survey-all participants provided consent by clicking on the "accept" button and continuing to the survey itself. the study was reviewed and approved by the university of regina research ethics board. the study was advertised on facebook between april th and june th , . the study ad instructed prospective participants to message the research team if they were interested. a member of the team then verified their eligibility to participate. if deemed eligible, they were provided with a link and password to access an online survey using qualtrics survey software. any diagnoses known to contribute to their infertility and to report which treatments had been suspended due to the pandemic. patient health questionnaire- (phq- ). the phq- [ ] consists of items based on dsm-iv criteria for diagnosing depressive disorders and is capable of determining both disorder presence and severity. items are scored on a -point likert scale ranging from (not at all) to (nearly every day), which indicates the degree participants have been bothered by the listed problems in the past weeks (total scores ranging from - ). in the current study, internal consistency was found to be α = . . an internal consistency above . suggests that the items of a scale are sufficiently correlated as to suggest that they measure the same general construct. intolerance of uncertainty scale short form- (ius- ). the ius- [ ] includes items on a -point scale ranging from (not at all characteristic of me) to (entirely characteristic of me). the questionnaire features three subscales: inhibitory anxiety, prospective anxiety, and a total score. in the current study, internal consistency was found to be α = . . revised life orientation test (lot-r). the lot-r [ ] is a -item questionnaire focusing on pessimism and optimism. the lot-r is on a -point scale ranging from (strongly disagree) to (strongly agree). of the -items, items contribute to an overall optimism score and are filler questions. in the current study, internal consistency was found to be α = . . revised defensive pessimism questionnaire (dpq-r). the dpq-r [ ] is a -item questionnaire focusing on defensive pessimism. the dpq-r is on a -point likert scale for a maximum total score of . in the current study, internal consistency was found to be α = . . illness cognition questionnaire (icq). the icq [ ] is an -item questionnaire with responses on a -point scale from "not at all" to "completely". for the purposes of this study, the words "my illness" were replaced with "my infertility. this measure has a three-factor structure, these factors being "helplessness" (e.g. my infertility controls my life"), "acceptance" (e.g. "i have learned to live with my infertility"), and "perceived benefits" (e.g. "i have learned a great deal from my infertility". infertility coping questionnaire. this questionnaire (s file) was developed by our research team because a comprehensive infertility-specific coping questionnaire was not deemed to exist. its creation was based on a careful review of all existing infertility-specific coping questionnaires. it began as a list of items, which was reduced to items after redundant items were removed, in collaboration with our patient-advisors. these items were retained to represent each of the following subscales: ) avoidance, ) active coping, ) find meaning, ) defensive pessimism, ) optimism, ) seek social support, ) behavioral engagement. responses are on a -point scale from "not at all" to "always". its internal consistency in the current study was found to be α = . . indicators of social support. participants were asked to indicate the number of people, apart from their romantic partner, with whom they speak openly about their infertility. they were also asked to rate, on a -point scale from 'very unhelpful' to 'very helpful', the degree to which their partner and the degree to which others have helped them cope with the suspension of fertility treatments. psychosocial impact of treatment suspensions. participants were asked to rate on a scale from - (very negative impact) to + (very positive impact), the extent to which their mental health had been impacted by treatment suspensions. they were also asked to rate the extent to which their mental health had been impacted by the other components of the pandemic (e.g. worries about the virus, living with restrictions on daily activities, unemployment, financial difficulties). quality of life before and after the pandemic. a -item quality of life measure [ ] asked participants to answer the following question: "taking everything in your life into account, please rate your overall quality of life on the following -point scale. one ( ) means life is very distressing; it's hard to imagine how it could get much worse. seven ( ) means life is great; it's hard to imagine how it could get much better. four ( ) means life is so-so, neither good nor bad." they were asked to answer this question twice: first, with the present in mind and second, thinking about their state in the month leading up to treatment suspensions. all analyses were conducted using sas . . the two primary outcomes for this study were change in quality of life rating (from before treatment suspensions) and mental health impact ratings. the wilcoxon signed rank test, a non-parametric test that does not require data to be normally distributed, was used to assess whether change in quality of life and mental health impact were significantly different from . spearman correlations, also a non-parametric test that does not require normally-distributed data, were used to examine the relationship between indicators of social support, personality traits, aspects of illness cognition, and coping strategies, on these two outcomes. for both illness cognitions and coping strategies, an additional linear regression analysis using proc glm was conducted including all cognitions or coping factors as predictors within the same model to clarify their independent effects. these were repeated after log-transforming both change in quality of life rating and mental health impact ratings to improve normality of these dependent variables, both of which were leftskewed (towards the negative end of the scale). power calculations were carried out in g � power. setting alpha at . , this study had % power to detect a correlation coefficient of . , which we judged to be the smallest clinically significant effect that we would want to be powered to detect. a total of women contacted us through facebook with interest in the study. thirty-eight participants did not pursue the conversation past an initial explanation of the study and were deemed ineligible to participate. finally, participants were removed from all analyses because the survey took less than minutes to complete, raising questions about the validity of responses. thus, participants were remaining for the current analysis. table reports the demographic and reproductive health characteristics of these women. participant ages ranged from to years and time spent trying to conceive ranged from to months. more than half of the participants had had an ivf cycle cancelled and approximately one third were in the midst of iui. % of the participants were ages - and % were aged or older. table summarizes the median psychosocial variables assessed in the study. median depressive symptoms were quite high based on the patient history questionnaire, with over half of the sample scoring above the clinical cut-off of . there was a statistically significant decline in self-reported quality of life of . / following the suspension of fertility treatments (s( ) = - , p < . ). when rating the mental health impact of treatment suspensions on a scale other % patient history questionnaire- score (/ ; = clinical cut-off) . median mental health impact of other pandemic components (- to + ) - . ( . ) mean # of confidants about infertility . ( . ) % from - (very negative impact) to + (very positive impact), respondents endorsed a median score of - . , which is significantly different from (s( ) = - , p < . ) (fig ) . overall, % of respondents reported that treatment suspensions had had a negative impact on mental health. baseline characteristics. neither age, years of education, annual income, nor the number of children a woman had were correlated with either change in quality of life or perceived mental health impact (p >. ). however, the length of time a woman had been trying to conceive was associated with a greater negative perceived mental health impact (r( ) = -. , p = . ) of treatment suspensions. personality traits. table depicts the correlation between three personality traits (trait optimism, defensive pessimism, and intolerance of uncertainty) that were considered potentially relevant under the current circumstances, in relation to the overall change in quality of life and the mental health impact attributed to fertility treatment suspensions. with regards to the psychological impact of fertility treatment suspensions during the covid- pandemic personality traits, defensive pessimism was related to a greater negative change in overall quality of life as well as a greater negative mental health impact of treatment suspensions. neither trait optimism nor intolerance of uncertainty were significantly related to any outcomes (p >. ). infertility-related cognitions. greater acceptance was associated with a more positive change in overall quality of life and lesser mental health impact attributed to treatment suspensions (table ) . furthermore, greater benefit-finding was associated with a smaller mental health impact of treatment suspensions while helplessness was associated with a greater negative mental health impact of treatment suspensions. however, when all three illness cognition factors were included in the same regression model as three simultaneous predictors of quality of life change, only acceptance was a significant predictor of treatment suspensions (β(se) = . ( . ), p < . ) while helplessness (β(se) = . ( . ), p = . ) and benefit-finding (β(se) = . ( . ), p = . ) were not. the same pattern was seen when examining the impact of illness cognitions on perceived mental health impact: acceptance was a significant predictor (β(se) = . ( . ), p < . ) while helplessness (β(se) = . ( . ), p = . ) and benefit-finding (β(se) = . ( . ), p = . ) were not. these results remained unchanged when quality of life change and mental health impact were log-transformed to improve normality of the dependent variable. coping strategies. the internal consistency of each of the seven subscales was examined. in instances where it was below . , items were removed to improve it. this resulted in items being removed. the remaining items are included in table . the internal consistency of the psychological impact of fertility treatment suspensions during the covid- pandemic the final subscales are as follows: ) avoidance, α = . , ) active coping, α = . , ) finding meaning, α = . , ) defensive pessimism, α = . , ) optimism, α = . , ) seek social support, α = . , and ) behavioural engagement, α = . . as shown in table , spearman correlations revealed that seeking social support was correlated with a more favourable change in quality of life and that engaging in less avoidance was associated with a more favourable change in mental health. when all seven coping factors were included in the same regression model, seeking social support remained the only factor predicting change in quality of life: specifically, a -point increase in mean item endorsement was associated with a . -point increase in quality of life (β(se) = . ( . ), p = . ). avoidance remained predictive of a greater negative mental health impact (β(sem) = - . ( ), p = . ). however, optimism emerged as predictive of a more favourable mental health impact of treatment suspensions (β(sem) = . ( . ), p = . ). the other coping factors were not significant predictors (p > . ). these results remained unchanged when quality of life change and mental health impact were log-transformed. sensitivity analyses: predictors of the mental health impact of other pandemic aspects. on a scale from - to + , participants were asked to reflect on the extent to which their mental health had been impacted by aspects of the covid- pandemic that were unrelated to their fertility treatments being cancelled (e.g. activity restrictions, social isolation, financial hardship, job loss). of the variables listed in table , defensive pessimism (r( ) = -. , p = . ), infertility acceptance (r( ) = . , p = . ), and infertility benefit-finding (r ( ) = . , p = . ) were weakly correlated with this outcome. the current study sought to examine the mental health impact of fertility treatment suspensions resulting from the covid- pandemic. furthermore, it sought to explore the psychosocial predictors of this psychological impact. overall, results suggest that the mental health impact of treatment suspensions is substantial: indeed, over % of respondents reported clinically significant depressive symptoms, a rate that is considerably higher than typical rates observed in this population, which hover closer to % (nelson, shindel, naughton, ohebshalom, & mulhall, ; volgsten et al., ) . similarly, over % of respondents endorsed a "- " or worse on a scale from - to + to reflect the mental health impact that treatment suspensions have had. these findings mirror a survey of patients at a new york city fertility clinic finding that % reported being "very" to "extremely" upset over treatment cancellations [ ] . however, the current study extends these findings by conducting a more detailed assessment seek information or advice that can help me achieve pregnancy take time to understand, identify, or express my feelings try to find meaning in my experience try to grow as a person as a result of this experience accept the situation as it is decide that i don't care prepare myself for the worst tell myself that it would be for the best if i didn't get pregnant tell myself that having biological children is not important believe that everything will work out stay optimistic that my efforts will be successful fantasize about how things might turn out believe that i will feel better in time try to find humor where i can seek social support seek emotional support professionals (e.g., counsellor, doctor) seek emotional support from friends or loved ones seek emotional support on the internet (e.g., blogs, chatrooms) seek emotional support from others with similar experience practice self-care (e.g., meditation, watch movie) of the mental health impact of treatment suspensions, as well as factors moderating this impact. several variables were found to moderate the psychological impact of treatment suspensions. perhaps unsurprisingly, women who had been trying to conceive for a longer time reported a greater negative mental health effect of treatment suspensions. furthermore, while the number of confidants a person had was unrelated to the impact of treatment suspensions, women who reported better emotional support from their partner and others also reported a smaller negative mental health impact. this is consistent with prior research finding that better quality social support is associated with lower infertility-related distress [ ] . it is noteworthy that the mean number of reported confidants was very small and that only % of respondents reported that their confidants were at least "somewhat" helpful in their efforts to cope with fertility treatment suspensions. women found their partners to be somewhat more helpful, however, as % were rated as at least "somewhat" helpful. furthermore, only % of women endorsed seeking social support from friends and loved ones at least "often". overall, these findings suggest that quality social support is beneficial for women who are struggling with the stresses of infertility but that this is not available to most women. this is consistent with research finding that unsupportive social interactions are commonly reported by women struggling with infertility and that these interactions predict greater distress [ , ] . thus, interventions aimed at improving the quality of the social support that they receive from others may be beneficial for this population. for example, a recent pilot study [ ] found that couples experiencing infertility benefited greatly from sessions of interpersonal therapy, a therapeutic approach that is primarily focused on improving the quality of one's interpersonal relationships. furthermore, in this study, interpersonal therapy was found to result in significantly better outcomes when compared to brief supportive therapy. with regards to personality traits, defensive pessimism was associated with a greater decline in quality of life, as well as a greater negative mental health impact of fertility treatment suspensions. defensive pessimism is the tendency to, in times of uncertainty, focus on potential negative outcomes and have low expectations in an effort to avoid disappointment [ , ] . although this approach may prove useful in motivating an individual to take steps toward avoiding an unwanted outcome under certain circumstances (spencer & norem, ) , our findings suggest that it is maladaptive in the context of the largely uncontrollable condition of infertility. spearman correlations revealed that greater acceptance and benefit-finding were associated with a lesser mental health impact of fertility treatment suspensions while greater helplessness was associated with a greater negative impact. however, in a regression model including all three infertility-related cognitions as predictors simultaneously, only acceptance was found to be a significant predictor. the importance of illness acceptance-that is, the extent to which an individual changes their focus from the elimination of their illness to living as well as possible with their illness-has been shown to be a strong predictor of wellbeing among those living with chronic pain [ ] [ ] [ ] . consistent with this, meta-analytic evidence suggests that acceptance and commitment therapy (act) [ ] , which aims to foster greater illness acceptance and reduce illness-related avoidance, is an effective intervention for chronic pain [ ] . to our knowledge, only one case study has documented the use of act for infertility-related distress [ ] , with promising effects. with regards to coping strategies, seeking social support and endorsing greater optimism were associated with better outcomes. in contrast, avoidance of infertility reminders was associated with worse outcomes. this latter finding is consistent with prior research finding that the endorsement of an avoidant coping style has been associated with worse psychological outcomes in the context of infertility [ ] [ ] [ ] [ ] . furthermore, in one of the few existing longitudinal studies of coping and psychological outcomes in infertility, the avoidance of reminders and thoughts concerning one's infertility was found to be a mediator between baseline vulnerability for psychopathology and -month distress levels [ ] . interventions targeting avoidance as a coping strategy, such as acceptance and commitment therapy, may be well-suited for infertility-related distress. although avoidance is often a clinical target in cognitive behavioural therapy, most studies that have applied this treatment approach to infertility have not directly targeted infertility-related avoidance [ , ] . the current study findings should be interpreted in light of some limitations. first, it is a cross-sectional investigation, providing only a snapshot of the interrelationships between psychosocial factors and infertility-related distress in the context of the covid- pandemic. the sample size was somewhat limited and is also not guaranteed to be representative of all women under similar circumstances-potentially, more distressed women were compelled to complete the survey as it appeared on their facebook feed. nonetheless, it provides some valuable insights into the emotional challenges that the covid- pandemic has introduced in the lives of women struggling with infertility. furthermore, it points to several targets for future interventions specifically targeting infertility-related distress. in summary, the current study suggests that the suspension of fertility treatments have had a significant negative impact on women's mental health and quality of life. low defensive pessimism, high-quality social support, greater infertility acceptance, and less use of avoidance, were all found to be protective factors against the negative effects of treatment suspensions on wellbeing. these findings suggest that additional mental health resources are likely to be needed in this population; they also suggest that infertility-specific psychological interventions should target social support, infertility acceptance, and infertility-related avoidance. supporting information s file. the infertility coping questionnaire, developed by the research team for the purposes of this study. (pdf) estimating the prevalence of infertility in canada psychometric evaluation of infertile couples a study on psychological strain in ivf patients sundstrom poromaa i. prevalence of psychiatric disorders in infertile women and men undergoing in vitro fertilization treatment the psychological impact of infertility: a comparison with patients with other medical conditions patient management and clinical recommendations during the coronavirus (covid- ) pandemic: american society of reproductive medicine the emotional impact of the asrm guidelines on fertility patients during the covid- pandemic. medrxiv monitoring depression treatment outcomes with the patient health questionnaire- fearing the unknown: a short version of the intolerance of uncertainty scale distinguishing optimism from neuroticism (and trait anxiety, selfmastery, and self-esteem): a reevaluation of the life orientation test defensive pessimism: harnessing anxiety as motivation the construct validity of the illness cognition questionnaire: the robustness of the three-factor structure across patients with chronic pain and chronic fatigue quality of life while living and aging with a spinal cord injury and other impairments dyadic dynamics of perceived social support in couples facing infertility the impact of social relations on the incidence of severe depressive symptoms among infertile women and men longitudinal analyses of the relationship between unsupportive social interactions and psychological adjustment among women with fertility problems. social science & medicine interpersonal psychotherapy versus brief supportive therapy for depressed infertile women: first pilot randomized controlled trial. archives of women's mental health reflection and distraction defensive pessimism, strategic optimism, and performance adjustment to chronic pain: the role of pain acceptance, coping strategies, and pain-related cognitions acceptance of pain is an independent predictor of mental well-being in patients with chronic pain: empirical evidence and reappraisal a prospective analysis of acceptance of pain and values-based action in patients with chronic pain. health psychology acceptance and commitment therapy: altering the verbal support for experiential avoidance acceptance and commitment therapy versus traditional cognitive behavioral therapy: a systematic review and meta-analysis of current empirical evidence. international journal of psychology and psychological therapy using acceptance and commitment therapy to treat infertility stress the psychological well-being of infertile women after a failed ivf attempt: the effects of coping counselling in infertility: individual, couple and group interventions. patient education and counseling gender differences in how men and women who are referred for ivf cope with infertility stress resilience and social support promote posttraumatic growth of women with infertility: the mediating role of positive coping psychosocial vulnerability, resilience resources, and coping with infertility: a longitudinal model of adjustment to primary ovarian insufficiency treatment of depression and anxiety in infertile women: cognitive behavioral therapy versus fluoxetine psychotherapy for infertility: a cognitive-behavioral approach for couples we thank tianna sauer for her help with data collection. conceptualization: jennifer l. gordon, ashley a. balsom. key: cord- -bb iydc authors: cohen, odeya; feder-bubis, paula; bar-dayan, yaron; adini, bruria title: promoting public health legal preparedness for emergencies: review of current trends and their relevance in light of the ebola crisis date: - - journal: glob health action doi: . /gha.v . sha: doc_id: cord_uid: bb iydc background: public health legal preparedness (phlp) for emergencies is a core component of the health system response. however, the implementation of health legal preparedness differs between low- and middle-income countries (lmic) and developed countries. objective: this paper examines recent trends regarding public health legal preparedness for emergencies and discusses its role in the recent ebola outbreak. design: a rigorous literature review was conducted using eight electronic databases as well as google scholar. the results encompassed peer-reviewed english articles, reports, theses, and position papers dating from to . earlier articles concerning regulatory actions were also examined. results: the importance of phlp has grown during the past decade and focuses mainly on infection–disease scenarios. amid lmics, it mostly refers to application of international regulations, whereas in developed states, it focuses on independent legislation and creation of conditions optimal to promoting an effective emergency management. among developed countries, the united states’ utilisation of health legal preparedness is the most advanced, including the creation of a model comprising four elements: law, competencies, information, and coordination. only limited research has been conducted in this field to date. nevertheless, in both developed and developing states, studies that focused on regulations and laws activated in health systems during emergencies, identified inconsistency and incoherence. the ebola outbreak plaguing west africa since has global implications, challenges and paralleling results, that were identified in this review. conclusions: the review has shown the need to broaden international regulations, to deepen reciprocity between countries, and to consider lmics health capacities, in order to strengthen the national health security. adopting elements of the health legal preparedness model is recommended. p lanning for the prevention and mitigation of morbidity, mortality, and environmental damage is fundamental to public health system preparedness for emergencies ( ) . an essential element in this planning process is the creation of a legal infrastructure to be activated during all phases of the emergency ( ) from preevent to recovery. the existence of a legal framework is particularly important in large scale crises ( ) and scenarios requiring humanitarian assistance ( ) . public health legal preparedness (phlp) involves more than legislation. moulton et al. ( ) defined phlp as 'legal bench-marks or standards essential to the preparedness of that system'. accordingly phlp includes ) laws/legal authorities; ) competencies of those who apply the law; ) information relevant for the application of the law; and ) coordination across sectors/jurisdictions. benjamin et al. ( ) state that although these components can be broadened the improvement of legal preparedness must address all global health action ae global health action . # odeya cohen et al. this is an open access article distributed under the terms of the creative commons attribution . international license (http://creativecommons.org/licenses/by/ . /), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for any purpose, even commercially, provided the original work is properly cited and states its license. four core elements and not focus on one element (e.g. legislation) only, which will lead to an incomplete solution ( ) . globalisation requires integrated, joint actions aimed to facilitate management of international threats including the use of phlp. the aim of this paper is to review recent theoretical and research trends regarding legal preparedness of the public health system for emergencies. in particular, the phlp during the current ebola crisis will be discussed. two parallel literature reviews were conducted to explore ) theoretical and research trends of phlp in developed countries, as well as in low-and middle-income countries (lmics), and ) the application of phlp during the recent ebola crisis. the reviews were conducted from september to december and encompassed peerreviewed articles published in english as well as reports, theses, and position papers. the study search encompassed eight electronic databases: cochrane, lexisnexis, proquest, pubmed, science direct, scopus, social science research network, and web of science; the google scholar search engine was also employed. the keywords used to extract relevant articles were public health, legal preparedness, and emergency. the year of publication was limited from to . however, if one of the reviewed articles emphasised findings that were based primarily on specific previous models or legislative actions, these earlier articles were also reviewed. due to the very limited findings concerning lmics, and in order to identify elements within the context of phlp that are implemented in those countries, additional keywords Á regulation and legislation Á were introduced to the review procedure. articles were only included in this review if they dealt with legal aspects of emergency situations. an exclusion criterion was a focus on routine issues (e.g. the obesity epidemic). this criterion was used to screen all abstracts included in the study. in the final stage, the articles were grouped by themes. review of application of phlp during the current ebola crisis keywords used to extract relevant articles were ebola, public health, legal preparedness, and emergency. the review was limited to . articles were included if they focused on legal issues regarding the ebola outbreak. this criterion was used to screen all abstracts included in the study. in the final stage, the articles were grouped by themes. the role of phlp in emergency response phlp plays an important role in the overall functioning of the health system during emergencies ( , ) . providing legal assistance in the midst of a disaster is central to any response plan ( , ). adini et al. ( ) found that following standard operating procedures in an emergency is crucial for assuring preparedness. other aspects of legal preparedness relate to the status of volunteers and their ability to provide humanitarian aid after a disaster ( ) . orenstein ( ) asserts that some laws, though appropriate for routine health activities, may hinder operations during emergencies. while declaring a state of emergency may facilitate waiving laws, the implications of such waivers must be carefully evaluated. during emergencies, as maintained by courtney et al. ( ) , healthcare providers operate under challenging conditions that may require deviation from existing treatment protocols, necessitating the development of strategies to protect against legal liabilities. similarly, chan ( ) argues in favour of granting legal immunity to private physicians to protect them against damage claims. conversely, it is important to protect the vulnerable population from uncertified personnel performing beyond their capacity. according to wang ( ) , this issue manifests itself more intensely in situations of cross-national mutual aid that are regarded as reciprocal gestures of goodwill, where programmes cross boundaries and achieve their expected goals quickly. thus, it is important to define obligations and rights and to establish roles, items, and standards. other researchers ( , ) perceived the competency of health workers as one of the core elements of phlp. pandemic outbreaks inflict widespread suffering and may negatively impact international economic stability ( ) . managing pandemics involves coordinating different aspects of the health and social systems. in such situations, the law, which is a small but crucial component of emergency preparedness ( , ) , assumes increased importance ( Á ). the speed with which viruses spread makes it imperative to ensure that a legal framework is in place to delineate mechanisms for effective epidemic management, within the country itself as well as globally ( , , ) . accordingly, efforts and reforms in this direction have been proposed and implemented worldwide, in developed countries as well as lmics ( ) from the united states to china ( ) . according to hodge ( ) , although legal reforms have occurred in the united states in the last years, three core challenges will continue to engage experts during the next decade: the legal implications of multiple emergency declarations, legal triage, and liability protection for practitioners and entities implementing crisis standards of care in response to declared emergencies ( ) . following outbreaks of severe acute respiratory syndrome (sars) and avian flu (h ni) in Á , the world health organization (who) adopted the international health regulations (ihr), whose goal is 'to prevent, protect against, control and provide a public health response to the international spread of disease' ( ). the who also published a checklist designed to help countries prepare effectively for infectious emergencies ( ) . the experiences of the global health system in dealing with the pandemic flu (h n ) had a significant impact on subsequent implementation of the ihr ( , , , ) . the ihr made valuable contributions in various areas, including issuing clear-cut reports from afflicted countries, integrating information from diverse sources, and monitoring unnecessary human rights limitations ( ) . in addition, it has become a useful decision support tool ( ) . however, analysis of how the ihr are applied in lmics reveals the challenges that still lie ahead ( ) . the main weakness is lack of resources and the ensuing inability to meet ihr demands and develop effective public health services ( , , , ) . in addition, the ihr do not make allowances for local and cultural variability ( , Á ). wilson et al. ( ) note several arenas in which ihr application needs to be strengthened, including declaring a health emergency in international scenarios and developing mechanisms to improve compliance with who and ihr recommendations. kool et al. ( ) noted that in order to achieve the ihr goals it is crucial to simplify identification and detection capacities in countries lacking advanced health systems. for example, it is necessary to base disease definitions on clinical signs and symptoms without the need for laboratory confirmation ( ) . epidemic scenarios that involve laws and phlp concerning isolation, quarantine, and social distancing are worthy of broad attention. limiting individual freedom in order to protect the public health has significant implications for managing infectious diseases ( , , , ) . preparing a legal infrastructure to administrate these situations is crucial, including declaration of an emergency situation which authorises public health officials to activate such means ( ) . nonetheless, operationalising them should not be based on legal facets alone, but should rather also consider judicial aspects. coercion may decrease the effectiveness of protection that could be achieved through voluntary compliance. it may also increase the probability of a constitutional crisis ( ). mosher ( ) notes that the law's promise of protection against abuses during an epidemic offers limited space for critics worried that individual liberties will yield to national security and public health concerns. in such cases, it is important to create an alternative framework in order to voice the views of those who are socially marginalised and have been largely silenced ( ) . the balance between individual rights and the common good a central aspect of phlp is balancing individual needs and the common good. the need to protect individual freedom arises in all types of emergency situations, but has significant implications for the management of infectious disease outbreaks ( , ) . turnock ( ) describes two major aims of public health laws: to protect and foster public health and to safeguard the rights of the individual. in emergency situations, imposing limitations on individual rights is unavoidable ( ) . in the united states, in the supreme court case jacobson v. massachusetts the court sustained the right of the authorities to use penalties to pressure people to be vaccinated during a smallpox epidemic. this ruling interpreted the use of the public health authority and the way the court balanced two strong competing values: the public good and individual liberties ( ) . gostin ( ) argues that the resulting ethical conflict is more acute in the period preceding the emergency. however, early legislation enables legal definition of individual rights, thereby facilitating optimal actions during the emergency itself ( ) . according to gerwin ( ) , during pandemics, governance that assures a legal balance between the needs of the public and those of the individual enhances public trust in the authorities' ability to manage the situation. by contrast, in the wake of the terror attack in the united states, the rights of the individual were significantly curtailed by a powerful government supported by legal measures ( ) . limited information was found regarding legal preparedness for emergencies in lmics. most sources focused exclusively on infectious disease management while only few related to legal aspects in the wider context of health system operation. fischer and kats ( ) mention the rural-to-urban migration phenomenon that produces 'mega-cities' of million or more inhabitants. according to united nations estimates, three-quarters of the megacities are located in lmics. this global trend exposes populations to disaster vulnerabilities and is associated with a dearth of risk management infrastructures Á physical, governmental, and legal ( ). nishtar et al. ( ) , analysing the pakistani health system, stated that one of its strengths is its legislative activism and the federal structure of the government, which promote the health system's ability to overcome challenges. according to them ( ) , it is important to establish laws and regulations governing publicÁprivate interactions, insurance, and e-health and thus contribute towards a coordinated, joint preparedness. van niekerk et al. ( ) found in studying south africa that certain laws enacted for disaster risk reduction are not implemented due to lack of funds and that laws need to be updated to ensure coordination between public and private sectors. globally, lmics play a crucial role in promoting prevention measures and immunisation programmes against diseases ( ) . kaddar et al. ( ) contend that the focus should be on middle-rather than low-income countries. regarding immunisation, vaccines are designated by the who according to the population's needs, supported by the global alliance for vaccines and immunization ( ) . an additional aspect of the legislative infrastructure relates to counterfeit medicines. despite the efforts of the who ( ), the regulatory structures prevailing in lmics cannot cope with the problem of counterfeit drugs and their use ( ) . health legal preparedness is more prevalent in developed countries compared to lmics. most publications dealing with phlp focus on the creation of legal conditions (e.g. emergency declaration, legal immunity) which may promote public health preparedness for emergencies, rather than implementation of international regulations. while the increasing importance of phlp is a worldwide trend, it is especially well developed in the united states. the first call to address the issue of health system legislation was published by the institute of medicine in ( ). this call was heeded after different emergency events that occurred during the first decade of the twenty-first century (the world trade center attack in , the mailing of envelopes containing anthrax, the sars epidemic in , and hurricane katrina in ) ( ) . these natural disasters and man-made events significantly impacted us society and government ( ) . in addition, they demonstrated the need for a policy that would include, inter alia, a legal response defining how the health system should manage such scenarios. a health legal preparedness model was developed and adapted by the us legal and health systems. it encompasses four core components ( , ): ) law Á the authoritative infrastructure of public health bodies that activate the public health system, ) competencies Á qualification of experts in areas common to legislation and health preparedness, ) information Á updating and publicising health laws for content experts and healthcare workers and ) coordination between legal systems and within emergency response agencies. current publications dealing with this model discuss researching and expanding its components ( Á ), as well as broadening its application to situations that the health system faces routinely ( ). current us literature reflects the recent improvements in the phlp field. studies dealing with preparedness are designed to reveal and resolve ethical and legal dilemmas in order to promote an optimal response for future situations. in addition to extensive coverage of legal aspects dealing with pandemic scenarios ( , , , , ) , publications also consider the impact of phlp on issues such as legal triage ( ), motivating health workers during emergencies ( , , ) , human rights during crises, legal coordination of relevant emergency bodies ( ) , and the effect of an emergency declaration on health system management ( , ) . hodge ( ) notes that upon declaration of a public health emergency the model state emergency health powers act ( ) authorises public health officials to undertake a set of activities dealing with early detection, as well as to care for and protect public health, treat exposed or infected persons, and seek out-ofstate volunteers. the declaration is defined to inform the population, through the media, using language that is cross-culturally accessible and understandable ( ) . all the items mentioned above reflect the creation of a legal infrastructure targeted for enhancing the us public health system. in the european union, emphasis is placed on routine application of a 'no border' policy, with minor references to emergencies ( Á ). european union law is based on legislation (directives and regulations) and decisions of the court of justice, which intervenes when the meaning or implementation of the legislation is unclear or fails during implementation ( ) . in the context of emergency preparedness, references to legal aspects focus on management of communicable disease outbreaks ( , , ) . greer et al. ( ) claim that the european union's laws play a dominant role in safeguarding the population's health, as their common laws and regulations significantly affect the health system. nonetheless, due to factors stemming from the complexity of the european union and the variability that exists among the european states' health systems, decisions are interpreted very generally with apparently vague provisions in the treaties. as a result, legislative interventions sometimes fail to adequately promote public health. for example, hatzianastasiou et al. ( ) found that greek laws are aligned with accepted practices of international law in the context of communicable diseases in terms of safeguarding individual rights, but exhibit a lack of coherence, clarity, or systematisation and are often perceived as incomprehensible ( ) . in order to understand phlp, it is vital to review studies which cover diverse types of legal management. although this topic could be significantly broadened, the description of current trends in phlp would be incomplete without referring to this issue. studying phlp during emergencies is complex, as there is a need to refer to diverse types of knowledge such as that concerning governance, policy, and perceptions of emergency professionals in order to provide meaningful insights ( ). legal preparedness shapes the health system and its emergency response in different ways. as such, there are various methodologies that prove efficient in studying these mechanisms. the integration of legislation into emergency management still seems to be a relatively neglected area ( ) . according to jacobson et al. ( ) , this is due to the lack of recognition that information about public health laws promotes best practices during emergencies. fox ( ) noted two methodological concerns regarding research on health policy governance and diseases. the first concerns the researchers' definition of governance, which influences what information they obtain and how they assess it. the second is that governance determines how diseases are conceptualised in order to make and implement policy. burris et al. ( ) classify three types of health laws: infrastructural laws, intervention/implementation laws, and secondary legislation. most studies in the field of law and health relate to intervention and secondary legislation and only a few relate to infrastructure and its effects on public health ( ). differences were found in the type of studies conducted in lmics versus developed countries. in the former, the majority of studies focused on the effectiveness of infrastructural laws, international regulations, and the need for more flexible regulations ( , ) . in developed states, studies focused on internal legislation, legal issues that might arise during emergencies, and advanced planning for future challenges ( , , ) . most studies relating to developed countries were conducted in the united states. differences among the individual states regarding the statutory/judicial system and the structure of healthcare agencies make it possible to investigate the effects of public health laws on the population's health. on the other hand, the variance that exists among the states influences knowledge management, which in turn affects health knowledge implementation within the framework of public health laws ( ) . rutkow et al. ( ) analysed differences between individual states in an effort to identify laws that impact the public health workforce and willingness to respond to emergencies. these differences can be well noted concerning emergency management, such as ensuring accessibility of the public to information via media that is influenced by cultural characteristics as defined in the model state emergency health powers act ( ) ( ) . reviewing the studies relating to phlp which were conducted in the last few years indicated that declaration of an emergency situation by the authorities was an essential component of emergency response and provided the health sector with flexibility and guidance concerning response parameters ( ) . other researchers studied perceptions regarding public health laws among organisations involved in managing emergencies. jacobson et al. ( ) found a gap between experts' perceptions of these laws and their basic aims, leading to severe deficiencies in health system preparedness. public health and disaster management professionals may differ in their understanding of the law ( ) , which hampers their ability to cooperate effectively during emergencies. according to kaufman et al. ( ) , staff training is the key to bridging differences in perception between public health workers and legal advisors. other studies dealt with legal means for motivating healthcare workers and offering enhanced legal protection against liability while reducing the incidence of harm claims during disasters and pandemics ( , ) . to deal with the lack of familiarity with legal preparedness, multi-professional panels were created to reach consensus concerning relevant issues ( , ) . in both developed and underdeveloped countries, researchers that investigated regulations and laws that activate the health system during emergencies found inconsistencies and lack of coherence ( , , ) . the ebola crisis: a case study of legal preparedness during a worldwide outbreak the ebola outbreak clearly illustrates the involvement of legal preparedness and response during an international crisis. this section will briefly review legal issues that demonstrate the different facets of the phlp. the re-emergence of ebola in in west africa, followed by the evacuation of stricken western healthcare workers to the united states, captured the world's attention ( , ) . the fatality rate of the ebola outbreak ranged from to % ( ) . affected countries are characterised by limited resources and political instability, with low capacity health systems and a lack of essential equipment and personnel. the probability that the ebola virus will take root in a high-resource country is small ( , , ) . the ebola crisis displayed the importance of legal preparedness for emergency situations from a global perspective, presenting ethical and legal dilemmas of affected and unaffected countries. managing such a crisis necessitated a multi-dimensional response, including effective functioning of health systems; coordination of diverse disciplines; international distribution; use of experimental drugs and medical procedures; safeguarding human rights; and consideration of implications in the health, political, and economic arenas. in addition, the ebola crisis brought to the forefront basic dilemmas concerning responsibility and reciprocity among developed states and lmics. it was essential to integrate the legal dimension into the global response in order to maximise strategies aimed at coordinating joint efforts to contain the ebola epidemic and save lives ( ) . the global response to the ebola outbreak was insufficient ( , ) . gostin and friedman ( ) argue that the outbreak uncovered a failure in global health leadership and that the who should be the global health leader. however, its budget is not commensurate with its responsibilities. as a result, some countries departed from the who directives and responded with excessive severity (e.g. imposing mandatory travel bans). in addition, several contaminated states could not realistically implement who recommendations and thus did not show full compliance with the guidelines ( ). hodge et al. ( ) note four issues that should be considered when creating legal preparedness for the ebola crisis: health workers' willingness to respond, experimental drugs and medical procedures, social-distancing measures in medical settings, and potential liabilities of healthcare workers and entities. addressing these issues could help mitigate fears, improve the public health response, protect the safety of healthcare workers and communities, and promote comprehensive medical and public health services ( ) . effective management of emergencies such as the ebola outbreak depends on the health systems' capacities ( ) . therefore, the most effective way to curb such outbreaks is to strengthen weak health systems and infrastructures ( , , ) . considering the vast differences between developed countries and lmics, immediate and extensive assistance should be provided ( ) . regarding the high mortality rate of healthcare workers in the ebola crisis ( ), hodge et al. ( ) noted that the infrastructures must offset the risks taken by frontline personnel with a commitment to their protection. this issue came to the forefront because western healthcare workers were evacuated, while frontline workers from affected places were not. in addition, the commitment to protect healthcare workers has to be standardised legally in affected countries as well as in ascending countries. in addition to the above, a central legal issue highlighted by this crisis is protection of human rights. the acute nature of the recent outbreak necessitated imposing quarantine, isolation, and other restrictive measures, in addition to monitoring movement of travellers. however, these measures were applied excessively and, rather than proving beneficial, caused under-reporting of diagnosed patients, lowered trust in the government, and sharpened economic, political, and social challenges ( , , , ) . during this crisis, human rights violations were wideranging, including blockage of rural areas in sierra leone by the army, shooting of people who unlawfully entered liberia from sierra leone, and broad-sweeping barricades in liberia that prevented access to food, medicine, and life-sustaining services. limiting travel from affected countries is contrary to who guidelines ( ) . rothstein ( ) noted four ethical principles that should be considered in the process of deciding whether quarantine is needed: necessity, effectiveness, and scientific rationale; proportionality and minimal infringement; humane supportive services; and public justification. regarding experimental treatments, it is important to formulate and adhere to ethical rules ( , , ) in order to mitigate inadvertent damage, which could worsen already strained relationships between health professionals and their patients ( ) . the factors mentioned above significantly affect the public's trust in responding agencies and governance systems activated during crises such as the ebola outbreak. the relationships between international health organisations are thus impacted ( ) in both underdeveloped ( ) and developed states ( , ) . this study reviews current trends regarding phlp for emergencies. over the past decade, in order to improve disaster planning and response ( ) , phlp has steadily grown in importance ( ) . however, while legal preparedness is important in diverse types of emergencies, most of the literature focuses exclusively on pandemic scenarios. furthermore, the status of phlp is influenced by the characteristics of the country involved. ihr represent a potentially revolutionary change in global health governance ( , ) . one criticism is that the regulations fail to make due allowance for local conditions and characteristics ( , Á ). in order for ihr to be appropriately realised, health organisations must create conditions that enhance the capacities of countries in need. regulatory attention paid to health systems' capacities may have a positive economic consequence: the provision of structured support during the pre-crisis period would significantly reduce post-outbreak outlays for assistance ( ) . according to mccloskey et al. ( ) , there is a need to develop trust and nurture effective, meaningful collaborations between countries to facilitate rapid detection of potential pandemics and initiation of public health actions. from this perspective, international regulations need to standardise the implementation of legal activities, motivated by a concern for global public health and well-being. coordination of such activities would promote routine inter-state assistance as well as collaboration during emergencies. thus, allowing the development of responses adapted to different countries' capacities without losing sight of the overall public health goals would help expand the capabilities of poorer countries. the ebola crisis reveals the importance of creating legal preparedness that takes into account the needs and capacities of both affected and unaffected countries ( , , , ) . inadequate capacities create severe stress on a country's ability to deal with the crisis. as a result, first and foremost, medical care is harmed. moreover, it inflicts a severe blow to individual rights. another facet of ethical and legal implications which was evident in the current crisis concerns the protection of health workers. this topic impacts both affected countries and the countries that provide assistance. reciprocity between developed countries and lmics is a global concern targeted to protect the world's health. the current global situation and the health status in developing countries directly affect the health of the world's population. thus, developed countries have an interest, beyond their responsibility, in catering to the health status of countries that lack vital means and resources. international legal preparedness, which considers the needs and capacities of different countries, will improve the assistance provided to countries that need it and regulate cooperation between the various stakeholders. implementation of the phlp model the us phlp model was intended to strengthen health system preparedness for routine scenarios as well as emergencies ( , ) . implementing the four core elements (law, competencies, information, and coordination) ( ) may increase legal preparedness by addressing the response of local legal and health systems for emergencies. the adoption of elements of the us model by developing countries, may promote the capacities of health systems' preparedness, which, in turn, will contribute to the increase of global health security. developed countries have an interest in assisting the local health capacities in lmics. international regulations incorporating these elements would in effect expand the resources available for coping with local and international public health emergencies. at present, resources are provided to underdeveloped states mainly to manage public health threats that affect developed countries Á even though other public health hazards may pose a greater threat to the lmic ( ) . the challenges identified in lmics in the course of the ebola crisis should be studied in order to assist the tailoring of appropriate legal preparedness in these countries. in certain countries, such as the united states, laws regarding infectious diseases provide the legal framework for health system operations in routine situations as well as during emergencies ( ) . it is vital to understand the ways in which less developed countries manage epidemics and translate this into a legislative framework that can promote the effectiveness of local health systems. research in the field of phlp efforts to improve health preparedness must be supported by adequate research. although a relatively new field, public health law provides important contributions to policy making and, by extension, to the health of the population ( ) . the dearth of studies in this area indicates a gap that needs to be filled. systematic research employing advanced techniques and sensitive data analyses can facilitate the study of legal preparedness and help elucidate the causal relationship between legal reforms and emergency preparedness of healthcare systems. the findings will help promote emergency preparedness in every country. this article provides highlights of current trends regarding phlp as reflected in the professional literature. nonetheless, this study did not fully examine legislation in the investigated countries. the keywords used in the literature search process did not include the word disaster. nevertheless, in checking the articles that were found using the search engines, researchers noted only one article that was not included in the findings based on the term emergency. in addition, the literature review only included papers in the english language, which might have excluded publications from non-english speaking countries. this article provides an overview of various issues regarding phlp but does not encompass all the particulars. the role of the legal component in building emergency health preparedness is gaining increasing recognition worldwide, although in many countries this has been expressed only in the context of infectious diseases. the ebola epidemic revealed that despite adoption of international regulations by lmics their health systems still lack the capacity to manage such epidemics. there is a need to boost effective implementation of international regulations by these states, thereby strengthening their ability to deal with routine and emergency situations and fostering global health security. the ihr present a good starting point, although additional work is needed to find a legal framework that will strengthen the willingness of the various stakeholders with different interests to cooperate and coordinate health preparedness programs. it is recommended that the components of the phlp model be widely adopted as a comprehensive basis for promoting legal preparedness in local health systems, backed by sophisticated methods of analysis directed at elucidating the effect of phlp on the capacity 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health system: performance and prospects after the th constitutional amendment alternative financing model for disaster risk reduction in south africa. pretoria, cape town: financial and fiscal commission global support for new vaccine implementation in middle-income countries global vaccine action plan regulatory underpinnings of global health security: fda's roles in preventing, detecting, and responding to global health threats committee for the study of the future of public health. the future of public health the role of law in public health preparedness: opportunities and challenges beyond public health emergency legal preparedness: rethinking best practices achieving public health legal preparedness: how dissonant views on public health law threaten emergency preparedness and response willingness of the local health department workforce to respond to infectious disease events: empirical, ethical, and legal considerations legal preparedness: care of the critically ill and injured 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advisory group of experts on immunization public health law in timor-leste communicating risk and promoting disease mitigation measures in epidemics and emerging disease settings ebola*underscoring the global disparities in health care resources caring for critically ill patients with ebola virus disease. perspectives from west africa chronology of ebola hemorrhagic fever outbreaks law, medicine, and public health preparedness: the case of ebola global and domestic legal preparedness and response: ebola outbreak ethical considerations of experimental interventions in the ebola outbreak ebola: a crisis in global health leadership ebola: towards an international health systems fund ebola: a failure of international collective action face to face with ebola*an emergency care center in sierra leone ebola and human rights in west africa containment in sierra leone: the inability of a state to confront ebola? from sars to ebola: legal and ethical considerations for modern quarantine ebola and the law in the united states: a short guide to public health authority and practical limits. emory legal studies research paper Á progress in disaster planning and preparedness since global health security agenda and the international health regulations: moving forward emerging infectious diseases and pandemic potential: status quo and reducing risk of global spread for the public's health: revitalizing law and policy to meet new challenges ac conducted the literature review and drafted the article. ba was responsible for the overall supervision of the study and critically revised the draft article. pfb and ybd critically revised the article drafts. the authors have not received any funding or benefits from industry or elsewhere to conduct this study. key: cord- - fzbbn authors: nagano, hitoshi; puppim de oliveira, jose a.; barros, allan kardec; costa junior, altair da silva title: the ‘heart kuznets curve’? understanding the relations between economic development and cardiac conditions date: - - journal: world dev doi: . /j.worlddev. . sha: doc_id: cord_uid: fzbbn as countries turn wealthier, some health indicators, such as child mortality, seem to have well-defined trends. however, others, including cardiovascular conditions, do not follow clear linear patterns of change with economic development. abnormal blood pressure is a serious health risk factor with consequences for population growth and longevity as well as public and private expenditure in health care and labor productivity. this also increases the risk of the population in certain pandemics, such as covid- . to determine the correlation of income and blood pressure, we analyzed time-series for the mean systolic blood pressure (sbp) of men’s population (mmhg) and nominal gross domestic product per capita (gdppc) for countries from to using regression and statistical analysis by pearson’s correlation (r). our study finds a trend similar to an inverted-u shaped curve, or a ‘heart kuznets curve’. there is a positive correlation (increase gdppc, increase sbp) in low-income countries, and a negative correlation in high-income countries (increase gdppc, decrease sbp). as country income rises people tend to change their diets and habits and have better access to health services and education, which affects blood pressure. however, the latter two may not offset the rise in blood pressure until countries reach a certain income. investing early in health education and preventive health care could avoid the sharp increase in blood pressure as countries develop, and therefore, avoiding the ‘heart kuznets curve’ and its economic and human impacts. the relation between economic development and health outcomes puzzles both economists and public health scholars (clark, ) . in recent decades, most countries advanced in nominal gross domestic product per capita (gdppc), but not in all health indicators (braveman et al., ; banerjee, ) . some health indicators, such as child mortality or malnutrition, seem to have a well-defined declining trend as countries and individuals turn wealthier (burkitt, ; fedorov & sahn, ; fogel, ; chen, lei, & zhou, ) . however, others, such as cardiovascular and various non-communicable diseases, do not follow clear patterns of change with economic development. socioeconomic factors, such as economic resources (e.g. income), inequality, social relations, education and occupation, are commonly used to explain health outcomes and investments (aly & grabowski, ; braveman et al., ; clark, ; jürges, kruk, & reinhold, ; woolf et al., ; brunello, fort, schneeweis, & winter-ebmer, ; lundborg, nilsson, & rooth, ) . for example, higher education is a strong indicator for normal blood pressure (colhoun, hemingway, & poulter, ; conen, glynn, ridker, buring, & albert, ; danaei et al., ) . certain studies mention that income and education are inversely associated with cardiovascular diseases, and low socio-economic condition is related to a higher prevalence of cardiovascular risk factors, such as high blood pressure (colhoun et al., ; braveman et al., ) . there is also a correlation between income https://doi.org/ . /j.worlddev. . - x/Ó elsevier ltd. all rights reserved. inequality and health outcomes, including cardiac conditions (kim, kawachi, vander hoorn, & ezzati, ; dewan et al., ) . the blood pressure is defined in technical terms as a result of cardiac output versus peripheral vascular resistance, but its composition depends on certain risk factors; some of which have relations with economic development and demographic features. the intrinsic factors are the genetic predisposition, age, gender and race (colhoun et al., ) . the extrinsic factors that affects it negatively are the lack of exercise, poor diet, obesity, excess salt, alcohol abuse, smoking and stress (colhoun et al., ; braveman et al., ; conen et al., ) , which are also related to socioeconomic status . in poor countries with an increase in income, there is a tendency to consume goods and services not previously available widely such as more carbohydrates, red meat, industrialized food, alcoholic beverages, and cigarettes (burkitt, ) . there is a higher consumption of kilocalories per capita per day as one has more income available for food consumption or has access to novel food products (dragone & ziebarth, ) ; people eat more but not necessarily better. healthy foods (e.g., non-transfats, reduced saturated fat and healthy oils) are generally more expensive and not commonly available for low-income people (fogel, ; danaei et al., ; banerjee, ; chow et al., ; ortega et al., ) . poor countries and poorer income groups also have less access to good health services, which may affect the access to preventive measure to reduce the risk of cardiovascular diseases. on the other hand, the poor also has a low use of individual motorized modes of transport, and large part of the population uses non-motorized modes (e.g. walking or cycling) (gwilliam, ; ahmad & puppim de oliveira, ) , which may provide some regular physical activity. as countries and certain groups of the population become richer, they have more resources to invest in health services, but their diets and life styles also change, not always in a healthier direction. for example, as india develops, richer households have higher chances to present individuals with high blood pressure and cardiac conditions (barik, desai, & vanneman, ) . thus, economic development can both contribute to minimize certain cardiac risk factors and exacerbate others. this study adds to the efforts to assess the impact of economic development on certain health outcomes. we use the male systolic blood pressure (sbp) as the health indicator. sbp is commonly used for individual and public health management. abnormal sbp can be a serious concern for a person or society as it is a risk factor for cardiovascular and kidney diseases (danaei et al., ) , with consequences not only for the population's health conditions and longevity but for public and private expenditure in health care (lee & kim, ; danaei et al., ; vallejo-torres & morris, woolf et al., . moreover, cardiovascular conditions can increase the risk of a person in epidemic outbreaks. for example, people with cardiovascular disease are at a higher risk of getting severe covid- disease (who, ). cardiovascular diseases have also a huge impact on productivity and the economy (leal, luengo-fernández, gray, petersen, & rayner, ) , which can economically justify certain measures to subsidize health care. thus, economic growth and health present a two-way relationship. sustained economic growth can lead to more investment in health, and consequently better health conditions. on the other hand, improved health of the population positively impacts labor productivity and human capital formation (atun & gurol-urganci, ) . however, we ask the following broad question, which is not consistently answered by the literature: is there any recognizable shape in the trends relating blood pressure and countries' income? several studies identify certain trends in the risk factors as societies develop but they are not conclusive on the relation between gdppc and blood pressure. for example, one study pointed that national income had a positive correlation with sbp among other risk factors in but the slope of this association became negative for women in (danaei et al., ) . mean blood pressure seems to have significantly dropped in high-income western countries between and , but it rose in other parts of the world, particularly in developing countries, such as many in sub-saharan africa (ncd, ) . other research outcomes identify trends in cardiac conditions among different social groups or races in a certain country (barik et al., ) . there are also studies that provide insights at the micro perspective, looking at the relation between sbp and education, access to health services and professional categories (conen et al., ) . they are important to identify how different contexts and development factors affect blood pressure, but there is no study that provides a consistent macro perspective trend between an economic development indicator and blood pressure. this relation is relevant to justify investments in health at the early stages of development in order to avoid cardiac problems in the future and their consequences on human development. in this regard, a crucial point for understanding how to improve public health in the development process is what an increase in income of countries means for the general health of their populations, particularly blood pressure (sbp) in this research. thus the contribution of this paper is to identify a general relationship between economic development and blood pressure, as the existing studies are not conclusive. the concept of the kuznets curve seems relevant to be tested in this context, as some studies already point rise and fall of blood pressure with different national incomes (danaei et al., (danaei et al., , ncd, ) . simon kuznets developed a breakthrough work on the relations between economic development and socioeconomic indicators. using empirical data, he was the first to describe the relationship between inequality and income, known as the 'kuznets curve' (kuznets (kuznets , . later on, though the original curve has been contested (atkinson & brandolini, ) , similar curves were noticed when plotting economic development and different forms of environmental degradation, such as air pollution or deforestation, defining what is called the 'environmental kuznets curve' (grossman & krueger, ; stern, common, & barbier, ; bhattarai & hammig, ; baland, bardhan, das, mookherjee, & sarkar, ) . kuznets curves have been determined for child labor (kambhampati & rajan, ) and tested for material use and carbon intensity (pothen & welsch, ; roberts & grimes, ) . moreover, empirically, per capita income can be associated with different environmental and socioeconomic indicators, which in turn are related to health (gangadharan & valenzuela, ; soares, ) . kuznets-like curves have been identified for certain health parameters such as injuries and life expectancy (bishai, quresh, & p. james p & ghaffar a. , ; clark, ) , and obesity (grecu & rotthoff, ) . concentration indices as a measure of health inequalities have also been observed to show a kuznets' curve behavior (costa-font, hernandez-quevedo, & sato, ) . thus, we decided to check whether the relation between blood pressure and gdppc follow a trend like a ''heart kuznets curve". if it follows, what would be the measures to tunnel through the curve and avoid the heart effects of economic development? for answering those questions, we evaluated the relationship between per capita gdp (gdppc) and systolic blood pressure (sbp) of men's populations, as an indicator of health. we assessed public time-series databases for countries, which contains compiled indicators of blood pressure and economic conditions in several categories. in particular, two main variables were chosen for this study: ) the mean systolic blood pressure (sbp) of men's population (mmhg), age standardized mean (icl, ) . ) nominal gross domestic product (gdp) per capita (gdppc) in american dollars (us$), in constant prices (the world bank, ). we collected data from to from these two different databases at gapminder (gapminder, ) . we used this period because, while the dataset for gdppc spans for a wide range of years, the historic series of sbp of men's populations in the public database we used is limited to to (gapminder ) . the mean sbp of the male population, age standardized mean counted in mm-hg, came from the database of the global burden of metabolic risk factors of chronic diseases collaborating group hosted at the school of public health, imperial college (icl, ). the mean is calculated as if each country had the same age composition as the world population, what minimize the aging bias. regarding the use of the sbp and its mean value, it is worth noticing that: (i) systolic blood pressure has been a better predictor of future events with high accuracy compared to diastolic blood pressure (sever, ) ; and (ii) reference studies use the mean as the reference of comparison between demographics and geography (ncd, ; ncd, ) . the gdp data comes from the world bank's world development indicators and represents the gross domestic product per capita (gdppc), nominal in constant us$ prices. we used nominal gdp instead of purchasing power parity (ppp) as the estimations of the former seems less controversial for long periods (taylor & taylor, ) . thus, the inflation, but not the differences in the cost of living between countries, has been taken into account (the world bank, ). in order to categorize countries, we used the gdppc average of four years, namely , , and . the country income categories were defined as: (a) low income countries: gdppc < us$ , ; (b) lower-mid: gdppc ranging from us$ , to us$ , ; (c) upper-mid: gdppc ranging from us$ , to us$ , ; (d) high: gdppc > us$ , (the world bank, ). we discarded countries with missing data and kept only countries with a minimum number of consecutive observations of both variables, which resulted in a dataset of countries (see the list of countries by categories of gdppc in table in annex i). we utilized r (v . . ) and python (v . ) languages as the tools for data formatting, transformations, visualization, statistical analysis by pearson's correlation (r) and regression analysis. built-in regression functions in r were utilized. in addition, we relied on open-source libraries: pandas (mckinney, ), ggplot (wickham, ) and seaborn (waskom, ) . when applicable, z-scores on time-series data was used. this corresponds to series transformation of the series fx i ginto another series fz i gand is given by where x and s x correspond to the mean and sample standard deviation of fx i g, respectively. for the sake of completeness, pearson' correlation r xy of series fx i g and fy i g, both with n elements, is calculated by where s x and s y correspond to the sample standard deviation of fx i g and fy i g, respectively. nevertheless, the choice of any research methodology has its limitations. in this case the following limitations can be identified with their justifications: (i) other risk factors could have been utilized. however, measurements of sbp represents one of the easiest, most inexpensive and widespread exams, when compared to other cardiovascular risk factors that require blood tests (e.g., diabetes). this allowed us to analyze longer time series for a large number of countries. (ii) a descriptive statistic approach is used instead of multiple regression analyses (with multiple explaining factors), since it provides a simpler, clear and visual evidence of our findings. a faceted approach, by gpppc-based country segmentation was used to achieve the outcome objectives. (iii) restriction to male population in the sample. men are more prone to hypertension than women in similar ages and, when affected by this condition present a greater blood pressure load on the organs (eison, phillips, ardeljan, & krakoff, ; reckelhoff, ) . thus, we decided to take male sbp as the population risk factor since it is a more stringent scenario. nevertheless, these questions should be further investigated in longitudinal population-based analyses in future studies. in general, gdp per capita (gdppc) increased over the years for almost all the countries and most of the countries had significant changes (increase or decrease) in sbp, with fewer countries with a neutral variation (only observations where À . < r < . ). fig. a shows the relation between gdppc and sbp for a sample of countries, which are representative of their income categories. the different colors represent the gdppc groups and dot sizes represent years (larger dot closer to , smaller dot closer to ). fig. a was our first plot, which motivated us to pursue further investigation of these associations for other countries, as it shows a trend of a kuznets curve. in fig. b , we grouped the countries in different bins classified by r-value. furthermore, we subgrouped each bin according to four different gdppc groups and we utilized the same color cue for gdppc group as in fig. a . we observe negative correlations between gdppc and sbp for high income countries as also shown in recent studies (ncd, ) . all countries with high gdppc presented r < À . , except three: united arab emirates, brunei and south korea. moreover, for the range À . < r < À . , we notice exclusively high gdppc countries. in contrast, low gdppc countries concentrates in the right side of the histogram, with more instances of positive correlation than negative. thus, we can infer that there is a positive correlation (increase gdppc, increase sbp) in low-income countries, and a negative correlation in high-income countries (increase gdppc, decrease sbp). thus, we decided to analyze the scores for all countries in the chosen time range . fig. shows the z-score of the gdppc and sbp for each one of gdppc groups. this transformation was necessary to evaluate the common trends per group, given that each country showed different spans across each variable. for example, mozambique, uganda, sudan and bhutan have different sbp spans (see fig. a ). all countries are plotted, along with a fitted linear regression line and % confidence interval, and respective p-values. the z-score allows us to normalize country variables, in order to capture the most dominant trend concerning each group. we observe that there is a monotonic trend on the line inclination, as we traverse the gdppc groups from low to high, resembling a kuznets curve; what we call 'heart kuznets curve' (see an illustration of it in fig. b ). in order to further discuss the steepness of the sbp, we chose a subset of countries variation, where the effects on general population are more detrimental. fig. a displays the increase in sbp according to gdppc, only for countries with positive pearson's correlations. the calculated coefficient per country denotes the sbp increase in mmhg for each additional us dollar in gdppc. fig. b shows the histogram of the regression coefficient for the gdppc groups as defined above. fig. b indicates that lower gdppc countries showed a sharper increase in sbp per dollar of increase in gdppc, when compared to higher income countries. in poorer countries, the mmhg increase is even steeper. countries that had very low income (gdppc below us$ in ) such as mozambique, uganda and sudan experienced a steeper increase in sbp, around mmhg during the analyzed period. for example, ethiopia had a coefficient of around . mmhg/us$, so for each additional us$ dollar in gdppc, the sbp increased . mmhg. on average, for us $ increase in gdppc, a mmhg rise in sbp is observed. in contrast, for the same gdppc increase, a gentler rise was observed for countries with slightly higher gdppc, such as egypt and fiji, where the sbp increased less than mmhg throughout the entire time series. for example, nicaragua showed a coefficient of around . mmhg/us$, thus on average equivalent to a . mmhg for every us$ increase in gdppc. in several countries, gdppc showed a steady increase along the years, which could lead us to believe that time could be the most important determinant. however, a comparison was made of the correlations of a) sbp versus gdppc and b) sbp versus time, showing much stronger correlation with gdppc (we provide additional results and discussions in annex ii). on the negative correlation countries, we plotted a sample of countries in fig. a and the histogram of negative linear regression coefficients in fig. b . clearly, the majority of such countries in this set belong to high income gdppc group. however, there are few outliers with a negative mmhg/us$ values that are low and lower-mid income countries. these are: (i) low: burundi, guinea-bissau, comoros, madagascar, zimbabwe, ghana (ii) lower-mid: colombia, ecuador, bolivia, syria, bulgaria, morocco, el salvador, tunisia, peru, belize, swaziland, romania in order to look further into this relationship, we performed a detrended correlation analysis (see annex iii). we found reasonable arguments to support our findings on the ''positive slope" of the sbp/gdppc relationship, which is related to the poorer countries. for the wealthier the trend of sbp decrease could have more influence of other factors, in addition to the gdppc increase. there are many studies analyzing blood pressure and cardiovascular conditions and treatments in specific countries, ethnicities or populations (gupta, al-odat, & gupta, ; ikeda, gakidou, hasegawa, & murray, ; fezeu, kengne, balkau, awah, & mbanya, ) or risk factors such as age (rodriguez, labarthe, huang, & lopez-gomez, ) . early exploratory studies already identified the changes in cardiovascular conditions as countries develop and modernize (burkitt, ; trowell, ) . previous comprehensive studies at a global scale also exist (kearney et al., ; kim et al., ; chow et al., ; ncd, ) , but they generally make a longitudinal analysis aggregated by country, income inequality or region, not correlating with income per capita in a consistent manner. our study revealed the pattern of a 'heart kuznets curve', showing a consistent positive correlation (increase gdppc, increase sbp) in low-income countries and the opposite in high-income countries (increase gdppc, decrease sbp). as countries' incomes increase sbp tends to increase up to a certain income, when the sbp tends to decline with the increase of gdppc, as in fig. b . in this aspect, south korea is an emblematic case of the 'heart kuznets curve' (see fig. a ). it is the only country among all countries in the sample that started the series as a low-mid income country in (gdppc of us$ , ) and ended up as a highincome country in (gdppc of us$ , ). most of the countries stayed in the same gdppc group or crossed to the next adjacent group. the increase of sbp in south korea was observed in the initial years of our series, with a turning point of gdppc around us $ , . as the gdppc continued to increase over this point, we observed an sbp decrease in the latter years of the series. even though south korea's overall pearson's r is neutral (r = . ), this breakdown into two different moments of the country matches earlier observations of the differences by income and reinforces the existence of the correlation and the idea of the 'heart kuznets curve'. south korea was able to consistently provide a better income and improve their socioeconomic status and at the same time reduce sbp after certain income to reverse the rising sbp trend. as the incomes in a poor country increase, the diet of the population changes rapidly increasing sbp, but the health services and education for the prevention of heart problems may not improve at the same pace to offset the changes in sbp caused by changes in diet (fuster, ; danaei et al., ; ncd, ) . thus, though increase in countries' income tends to provide more access to health services, as countries invest more in health systems and individuals have more income to invest in health care, this may not compensate the negative changes in sbp until a country reaches a certain income per capita, as good quality public health care for the majority of the population takes time to be properly built and may not be a priority for policymakers at early economic development stage (makhoul, ) . at a certain income, it is noticed an inflection point in the sbp trend (in south korea at around us$ , of gdppc). the health system and health education improves to make access to health services (e.g., regular blood pressure checks and advice from a cardiologist or nutritionist) and preventive care (e.g., education for awareness about the importance of a more balanced diet) sufficiently more common for the population to a point to revert the rising trend in sbp (danaei et al., ; ncd, ) . another important determinant of sbp is physical activity, which has also some relations with economic development. regular physical activity is associated with a substantial reduction in cardiovascular disease risks, even in groups with high risks (humphreys, mcleod, & ruseski, ) . in rapid developing economies, urbanization (especially improved housing and transport infrastructure) and industrialization leads to profound shifts not only in how people eat, but how they move, work and exercise (chow et al., ; danaei et al., ) . people tend to move from agricultural jobs, which tend to require more physical activities, to work in offices, shops or industrial plants. as individuals get richer, they also tend to move from non-motorized (e.g., walk or bicycle) to use more motorized transportation (gwilliam, ; ahmad & puppim de oliveira, ) . thus, lack of physical activities among the population seems to become more common as a country's income rises. as the prevalence of a sedentary lifestyle increases, the risk of heart problems increases. for instance, an isolated risk factor, such as obesity per se, is not the only or the most important factor to determine health. the overweight and active people can be healthier than skinny and sedentary people. the metabolically healthy overweight and well-educated people may not suffer from conditions such as diabetes or high blood pressure (de backer & de bacquer, ; ortega et al., ) . obesity has also socioeconomic causes, such as income and education, and has significant economic impacts (cawley, ) . social programs, such as cash transfers, and work activity have ambiguous effects on weight (levasseur, ; feng, li, & smith, ) . health specialists suggest the implementation of recommendations regarding diet and physical activity should be a top priority for all (de backer & de bacquer, ; chow et al., ; danaei et al., ) , including economic incentives such as taxes on unhealthy food and drinks (cawley, ) . as income rises over certain point, health advice and education tend to improve and make people more aware of the importance of physical activity and diet, contributing to reduce sbp (braveman et al., ; danaei et al., ) . thus, increase in income alone is not translated into wellness automatically. it may worsen the risk factors for cardiovascular disease, if health education and access to health care does not come together with the higher incomes. maybe the effective access to these services happen just after a certain income turning point. therefore, a country with rising income does not always mean becoming a healthier country. how could we then turn income into (heart) health? besides aggregate income, income inequality is also correlated to health outcomes and inequity in health service access (clark, ; kim et al., ; baland et al., ; vallejo-torres & morris, ) . reducing inequalities can widen the access to quality health services. moreover, health information and education can transform one's behavior (colhoun et al., ; conen et al., ; brunello et al., ) , as education is an important socioeconomic factor determinant of blood pressure progression and a powerful and independent predictor (braveman et al., ; conen et al., ) , though not stronger than gdppc (see annex iv). a better income should also come with improvement in health education to reduce health risks (conen et al., ; jurges et al. ; woolf et al., ; lundborg et al., ) . for example, higher income individuals reduce more the intake of fat than poorer one when receiving hypertension diagnosis (zhao, konishi, & glewwe, ) . other factors, such as mother's education, are key for improving nutrition in their children (behrman, deolalikar, & wolfe, ) . socioeconomic determinants are strongly associated to health risk factors, which affects cardiovascular diseases (conen et al., ; danaei et al., ) . as large part of the world population is poor or has low income (pew research center, ) , in order to improve global health inequities, policy makers, including those in governments and international organizations, should develop new approaches to control these major risks for cardiovascular diseases in poorer countries in a more effective manner (friedrich, ) . in general, investments in health tend to address the need of the ruling privileged elites and not the wider population (makhoul, ; mobarak, rajkumar, & cropper, ) , which are also more vulnerable to economic crises in terms of health (pradhan, saadah, & sparrow, ; shkolnikov, cornia, leon, & meslé, ) . health problems can have a significant impact on the wealth of elders (lee & kim, ) . public programs that improve access to health services can reduce health inequalities and have significant impact on the most vulnerable ( van de gaer, vandenbossche, figueroa, ; bagnoli, ) . in turn, healthier societies can be more productive. poor children with more access to public health care improve their attendance and scores (alcaraz, chiquiar, orraca, & salcedo, ) . there are opportunities through the understanding that there is a 'heart kuznets curve' for designing a better investment strategy in health care and health education that can lead to better lifestyles and reduce the risks of high sbp at early stages of development, improving the general health of the population and saving large amounts of resources in the later stages of economic development. young adults with good cardiovascular health result in lower future costs in health care (schiman et al., ) . public policies can help, informing and providing the knowledge and infrastructure to change habits (e.g., areas to exercise, opportunities for activity using non-motorized transportation). investments in health education and services to avoid cardiovascular diseases in early stages of development can also mitigate the climbing costs of the health systems. income and health of populations and countries are reciprocally related. we found a strong relationship between gross domestic product per capita (gdppc) and population's blood pressure, following a 'heart kuznets curve'. in countries with low and medium income, the increase in gdppc increased the mean systolic blood pressure (sbp) between and . in rich countries, there was reduction of the average blood pressure with increase in income. furthermore, the poorer the country is, more acute sbp jumps with rising incomes were observed. however, the heart kuznets curve is not deterministic and valid for all countries and all conditions. kuznets curves in other areas have been contested in several grounds, including inequality (frazer, ) and environmental pollution, showing that the inverted-u shape can occur only under certain policy conditions (ezzati, singer, & kammen, ) . in health policy, removal of user fees tends to increase access to health services in countries in early stages of development, particularly for those more vulnerable (hangoma, robberstad, & aakvik, ) . also, there are ways countries can better steward their health systems to be more effective in the use of resources and the achievement of health outcomes (brinkerhoff, cross, sharma, & williamson, ; chan et al., ) . in addition to those pointed out in methodology section, our study has limitations. despite the strong correlation in some countries, we understand that within the same country there are various population groups with different socio-economic status. countries also have distinct age distribution and ethnicities. it could be revealing to perform a deeper analysis into micro regions to better understand the behavior of individuals and groups and its relation to systemic blood pressure in different socio-political and cultural contexts. moreover, the relations between changes in income, changes in other socioeconomic factors and cardiovascular risk factors should be empirically tested through further quantitative and qualitative studies with multiple independent variables. we tested the correlation between education (mean years of schooling) and sbp, and though these two variables are correlated, the correlation between gdppc and sbp is stronger (annex iv, fig. ) . nevertheless, education and other factors, such as investments in health infrastructure, have an important impact on sbp, and future research could identify macro trends in those factors. a myriad of other variables, including mental and psychological factors, such as stress caused by economic instability, working conditions or vulnerability to natural disasters, also have influence in cardiac conditions, as pointed by some studies (katsouyanni, kogevinas, & trichopoulos, ; kivimäki et al., ) . in developing countries, other factors, such as socio-economic vulnerability or poor urban conditions, which could increase stress, could be further investigated to identify any trends (suchday, kapur, ewart, & friedberg, ) . thus, we suggest further studies involving several independent variables, such as using multiple regressions, for future research, as the objective of this study was limited to the macro trends in the relation between two variables (income per capita and blood pressure). finally, studies using other proxies of economic development and blood pressure could be carried out to check the robustness of the trends we identified in this study. rise in blood pressure has created a growing global burden for the current and future generations (olsen et al., ) . it also increases the risks of the population in certain pandemics, such as the covid- (who, ) . the un development agenda in its sustainable development goal ('ensure healthy lives and promote well-being for all at all ages') calls for a ''strengthened capacity of all countries in health risk reduction and management" (un, ) . despite the trends in improvement in income in most countries in the last decades, this is apparently not associated with an improvement in health education, access to health care and recommendations to prevent cardiovascular diseases by necessary changes in lifestyles in developing countries. the epidemic of cardiovascular problems and other non-communicable diseases can be prevented in many countries in the future with investments in building capacity for promoting health education and preventive services in the early stages of economic development. thus, we could tunnel through or avoid the 'heart kuznets curve' in many situations. annex ii -correlation of year/sbp and gdppc/sbp it can be argued that sbp increase in lower income countries is more associated with temporal trends than with the increase or decrease of gdppc. temporal changes could for example be associated with adoption of western diet, if we accept that globalization had such a worldwide effect over the analyzed timeframe. thus, we decided to compare the correlation between sbp and year with the correlation of gdppc and sbp. fig. shows that the bulk of countries show up above the equality line (y = x). even though the values in x-axis show density spread in (- , ) interval, y-axis values are more concentrated in the upper quadrants. in other words, the sbp's correlation with gdppc is in general higher than time (year). moreover, this effect is more pronounced for low income countries. to further exemplify the lesser association with time trends, we plot in fig. three low income countries, namely niger, mozambique and senegal. in all, we see: (i) decreasing sbp accompanied by decrease gdppc, followed by increase in both as time evolves; and (ii) a weak correlation with time. the correlation of these three countries are shown in table . all three countries show up in the upper quadrants of fig. a , where niger and senegal in the left handside. we believe that temporal trends observed in the period, for example globalization of food culture, are less contributing factors compared with income. in this annex, we report the correlations after applying first difference in both sbp and gdppc time series (fig. ) . we observe low and lower-mid countries with positive correlations, but not as high as the correlations observed in fig. . still, if we combine low & lower-mid countries, approximately % present correlation above . . see table . on the other hand, we could not observe a pattern for the distribution for countries with higher income. in fact, those countries now show up in the positive territory and span a larger range of correlations. sbp trend downward with gdppc increase, but the inferences that additional wealth alone may bring better health could not fully verified. in summary, from this analysis we argue that the ''positive slope" portion of the kuznets curve has a more solid reasoning, with evidence also from annex ii, while the ''negative slope" part can be more influenced by other factors in place, though gdppc still has a strong correlation with sbp. in 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how are income and wealth linked to health and longevity? does information on health status lead to a healthier lifestyle? evidence from china on the effect of hypertension diagnosis on food consumption we declare no direct sources of financial assistance. we acknowledge the support of fgv for the institutional research efforts for this research to be completed. the authors declare that they have no conflict of interest. key: cord- -vbwo djw authors: dirlikov, emilio; fechter-leggett, ethan; thorne, stacy l.; worrell, caitlin m.; smith-grant, jennifer c.; chang, jonathan; oster, alexandra m.; bjork, adam; young, stanley; perez, alvina u.; aden, tricia; anderson, mark; farrall, susan; jones-wormley, jaime; walters, katherine hendricks; leblanc, tanya t.; kone, rebecca greco; hunter, david; cooley, laura a.; krishnasamy, vikram; fuld, jennifer; luna-pinto, carolina; williams, tanya; o’connor, ann; nett, randall j.; villanueva, julie; oussayef, nadia l.; walke, henry t.; shugart, jill m.; honein, margaret a.; rose, dale a.; bang, noelle anderson, cdc; david; barham, terrika; benton, shaliondel; blain, amy; boyd, mary; bradley, bruce; bright, shakia; bruce, michael; cabada, victor; castro, georgina; cherry-brown, dena; coleman, erik; cowins, janet; craig, pamela; daniel, johnni; davis, darlene; de, stacy; drexler, naomi; dull, jessica; farr, sherry; finley, phillip; finn, karrie; freeman, denise; fukayama, corinne; gaarenstroom, nicole; ghertner, micha; glover, maleeka; grant, gail; griffing, sean; harris, demoncheri; harris, diane; hayes, nikki; hee, seung; henry, corey; henry, donna; hines, janine; hudson, amy; iqbal, kashif; isenberg, jennifer; jenkins, mary; kabore, charlotte; karpathy, sandor; kennebrew, daphne; kun, karen; lash, ryan; lavinghouze, rene; leavitt, rachel; lee, sooji; leidman, eva; leon, oscar; leonard, sarah; lowry, garry; lundeen, elizabeth; lynch, mechele; mabry, michon; manning, jana; mccall, kelsey; mcgruder, henraya; merkle, sarah; meyer, jenna; moonan, patrick; moore, jazmyn; norwood, pamelian; nu, seseni; oeltmann, john; palipudi, krishna; parise, monica; parry, ritchard; patta, abrienne; pendergraft, chandra; pettrone, kristen; pfeifer, heidi; powell, tracy; preacely, nykiconia; qi, yanping; ricaldi, jessica; richardson-moore, regina; roberson, lashonda; rodriguez, sergio; rodriguez, tomas; ruiz, andrew; saydah, sharon; senesie, abdoulie; sexton, connie; shanklin, shari; sieradzki, christopher; simpson, amberia; simpson, de’lisa; snodgrass, stephanie; speissegger, lisa; spieckerman, alisa; stollar, danielle; stone, nimalie; sunshine, brittany; swann, philana; uddin, rezwana; valencia, diana; walker, chastity; washington, malaika; welch, seh; williams, shawna; woodruff, rebecca; woodson, evonne; yatabe, graydon; yusuf, hussain title: cdc deployments to state, tribal, local, and territorial health departments for covid- emergency public health response — united states, january –july , date: - - journal: mmwr morb mortal wkly rep doi: . /mmwr.mm a sha: doc_id: cord_uid: vbwo djw coronavirus disease (covid- ) is a viral respiratory illness caused by sars-cov- . during january -july , , in response to official requests for assistance with covid- emergency public health response activities, cdc deployed teams to assist state, tribal, local, and territorial health departments. cdc deployment data were analyzed to summarize activities by deployed cdc teams in assisting state, tribal, local, and territorial health departments to identify and implement measures to contain sars-cov- transmission ( ). deployed teams assisted with the investigation of transmission in high-risk congregate settings, such as long-term care facilities ( deployments; % of total), food processing facilities ( ; %), correctional facilities ( ; %), and settings that provide services to persons experiencing homelessness ( ; %). among the deployed teams, ( %) provided assistance to state health departments, ( %) to tribal health departments, ( %) to local health departments, and eight ( %) to territorial health departments. cdc collaborations with health departments have strengthened local capacity and provided outbreak response support. collaborations focused attention on health equity issues among disproportionately affected populations (e.g., racial and ethnic minority populations, essential frontline workers, and persons experiencing homelessness) and through a place-based focus (e.g., persons living in rural or frontier areas). these collaborations also facilitated enhanced characterization of covid- epidemiology, directly contributing to cdc data-informed guidance, including guidance for serial testing as a containment strategy in high-risk congregate settings, targeted interventions and prevention efforts among workers at food processing facilities, and social distancing. coronavirus disease (covid- ) is a viral respiratory illness caused by sars-cov- . during january -july , , in response to official requests for assistance with covid- emergency public health response activities, cdc deployed teams to assist state, tribal, local, and territorial health departments. cdc deployment data were analyzed to summarize activities by deployed cdc teams in assisting state, tribal, local, and territorial health departments to identify and implement measures to contain sars-cov- transmission ( ) . deployed teams assisted with the investigation of transmission in high-risk congregate settings, such as long-term care facilities ( deployments; % of total), food processing facilities ( ; %), correctional facilities ( ; %), and settings that provide services to persons experiencing homelessness ( ; %). among the deployed teams, ( %) provided assistance to state health departments, ( %) to tribal health departments, ( %) to local health departments, and eight ( %) to territorial health departments. cdc collaborations with health departments have strengthened local capacity and provided outbreak response support. collaborations focused attention on health equity issues among disproportionately affected populations (e.g., racial and ethnic minority populations, essential frontline workers, and persons experiencing homelessness) and through a place-based focus (e.g., persons living in rural or frontier areas). these collaborations also facilitated enhanced characterization of covid- epidemiology, directly contributing to cdc data-informed guidance, including guidance for serial testing as a containment strategy in high-risk congregate settings, targeted interventions and prevention efforts among workers at food processing facilities, and social distancing. on january , , cdc activated its emergency operations center to facilitate coordination for domestic and international covid- response efforts ( ) ; the same day, at the request of the washington state health department, cdc deployed a team to washington to support the health department's epidemiologic investigation of the first u.s. case of covid- in a traveler returning from china ( ). on march , cdc established a dedicated covid- response section to support state, tribal, local, and territorial health departments ( ) . cdc deployment data were analyzed to describe activities by deployed cdc teams in assisting state, tribal, local, and territorial health departments in the identification and implementation of measures to contain sars-cov- transmission ( ). the cdc covid- state, tribal, local, and territorial response section provides support to health departments by responding to inquiries, identifying and collaborating with cdc subject matter experts, and deploying cdc teams in response to receipt of official requests for assistance from health departments. dedicated teams of cdc subject matter experts have participated in evaluating contact tracing efforts and have investigated covid- epidemiology in counties with rapidly increasing numbers of cases and incidence ("hotspots") to identify jurisdictions needing targeted support ( ) . further, the cdc covid- state, tribal, local, and territorial response section helps coordinate efforts between cdc, health departments, and subject matter experts across federal agencies and other organizations including the cdc foundation, the national association of county and city health officials, the association of public health laboratories, association of state and territorial health officials, and the council of state and territorial epidemiologists. the cdc covid- state, tribal, local, and territorial response section coordinated deployment requirements with health departments and selected staff members with the necessary skills after an official request for assistance. cdc covid- response general staff, division of emergency operations, and office of safety, security, and asset management ensured that all deployers were supported before, during, and after deployment, including providing briefings before and after deployments; coordinating risk assessments, medical clearance, and travel and lodging arrangements; and issuing deployment-essential equipment, including personal protective equipment to prevent sars-cov- transmission during field deployments. deployer feedback received during postdeployment debriefings were used to improve deployment processes and procedures for subsequent deployments. during january -july , in response to official requests for assistance, , cdc staff members participated in cdc deployment teams to assist state, tribal, local, and territorial health departments with covid- emergency public health response activities (figure )*; some persons deployed multiple times. trends in the deployment of cdc teams generally followed trends in national covid- case counts. the number of deployed field teams per week increased during january-april and declined during may-june; however, from mid-june to july , the number of deployed teams increased ( figure ). among ( %) teams that had completed deployment by july , the mean deployment duration was days * includes both in-field and remote deployments and does not include cdc staff members deployed to u.s. quarantine stations and airports, repatriations centers, or as part of outbreak response on cruise ships. (range - days) (table) . among the remaining teams deployed as of july , duration of deployment ranged from - days; several teams were providing sustained epidemiologic support. among the teams deployed following official requests for assistance, ( %) provided assistance to state health departments, ( %) to tribal health departments, ( %) to local health departments, and eight ( %) to territorial health departments. because state, tribal, local, and territorial health departments could request assistance with a range of public health activities, deployed team members possessed diverse technical skills and expertise, and a single team could provide technical assistance in multiple areas. the top five areas of technical assistance provided by deployed teams were the following: ) epidemiologic support ( teams; %), ) infection prevention and control in health care settings ( ; %), ) health communications ( ; %), ) community mitigation ( ; %), and ) occupational safety and health ( ; %). some deployed cdc teams provided subject matter expertise in investigation figure . location of deployments* by cdc staff members to state, tribal, local, and territorial health departments -united states, january -july , and mitigation of sars-cov- transmission in high-risk congregate settings, which often include populations at increased risk for severe covid- -associated outcomes, such as longterm care facilities ( teams; %), food processing facilities ( teams; %), correctional facilities ( ; %), and settings that provide services to persons experiencing homelessness ( ; %). knowledge, attitudes, and practices surveys helped involve community members in identifying barriers to services, difficulties experienced when trying to follow prevention actions, and preferred communication channels. aligned with cdc's covid- health equity strategy, † some teams focused attention on supporting local officials in describing health equity issues, such as describing sars-cov- transmission among disproportionately affected racial and ethnic minority populations, essential frontline workers, persons experiencing homelessness, as well as through a place-based focus, such as responding to covid- outbreaks in rural communities and frontier areas. twenty-eight ( %) teams deployed specifically to assist in addressing sars-cov- transmission among racial and ethnic minority groups, including supporting tribal health departments and those focused on covid- among migrant farm workers. because cdc staff members could deploy more than once, the , cdc staff member deployments included † https://www.cdc.gov/coronavirus/ -ncov/downloads/community/cdc-strategy.pdf. individual cdc staff members. overall, ( %) staff members deployed once, ( %) deployed twice, and ( %) deployed three or more times. among the , individual deployments, the top four primary deployer roles were epidemiologic support ( ; %), leadership ( ; %), infection prevention and control ( ; %), and clinical support ( ; %); additional primary deployer roles included data science, laboratory science, health communications and community outreach, occupational safety and health, coordination, veterinary science, and behavioral science. deployed cdc staff members helped increase local capacity by assisting with developing data collection instruments, conducting trainings on covid- case investigation and contact tracing, and providing support to improve public health information technology systems. cdc continues to respond to official requests for assistance from state, tribal, local, and territorial health departments toward supporting covid- emergency public health response activities, including through the deployment of cdc staff members. cdc deployments were responsive to evolving public health needs, as reflected by similar trends in number of deployed teams and reported national case counts. approximately cdc staff members deployed, and approximately one half of individual deployments were completed by staff members who had deployed more than once. on average, does not include deployments to u.s. quarantine stations and airports, repatriations centers, as part of outbreak response on cruise ships, or other response teams. some individual cdc staff members were deployed more than once. † deployed teams provided a diversity of technical assistance, and a single team could assist with more than one area of technical assistance. § total differs from sum of all high-risk congregate settings because some teams worked in multiple high-risk congregate settings. ¶ percent represents percentage of total cdc staff members who deployed. ** leadership includes staff members with any deployment roles listed as "senior," "lead," "deputy," "team lead," "co-lead," or "deputy lead," with leadership staff member classification superseding all other classifications. † † clinical support includes staff members who were physicians, nurses, or pharmacists who were not listed with an alternate primary deployer role. § § subject matter expertise includes staff members with any deployment roles listed as "sme," "specialist," and deployments under covid- resource assistance field team and centers for medicare & medicaid services teams. ¶ ¶ other includes staff members listed as vessel sanitation, technical assistance, focus groups, and individual deployments that could not otherwise be classified (n = ). teams deployed for nearly weeks, and several teams provided more sustained support. collaborations between health departments and cdc have provided critical information for developing new or revised national guidance including improved mitigation strategies (https://www.cdc.gov/coronavirus/ -ncov/communication/guidance-list.html). for example, cdc and health departments developed and implemented the use of serial testing as a successful containment strategy, which was used to interrupt transmission in long-term care facilities in washington § ( ), in correctional and detention facilities in louisiana ¶ ( ) , and among residents and staff members of homeless shelters in washington** ( ) . multijurisdictional support helped describe § https://www.cdc.gov/longtermcare/index.html. ¶ https://www.cdc.gov/coronavirus/ -ncov/community/correctiondetention/guidance-correctional-detention.html. ** https://www.cdc.gov/coronavirus/ -ncov/community/homeless-shelters/ plan-prepare-respond.html. the need for targeted interventions and prevention efforts among workers at food processing facilities, including an analysis of covid- cases among meat and poultry processing facility workers in states that found that among cases with race/ethnicity reported, % occurred among racial or ethnic minorities † † ( ) . more generally, deployed teams assisted health departments conduct epidemiologic investigation after outbreaks associated with social gatherings, such as cases and deaths resulting from transmission at two family gatherings in chicago ( ) ; the results of these investigations helped support and refine cdc covid- recommendations on social distancing. the impact of collaborations extends beyond health agencies. for example, on april , the centers for medicare & medicaid services and cdc issued guidance to implement universal testing of long-term care facility residents, covered what is already known about this topic? as part of the covid- emergency public health response, cdc deploys field teams upon request to assist state, tribal, local, and territorial health departments. what is added by this report? as of july , , cdc had deployed teams to assist state, tribal, local, and territorial health departments. teams worked with local counterparts to address transmission in high-risk settings, including long-term care facilities ( %), food processing facilities ( %), correctional facilities ( %), and settings providing services to persons experiencing homelessness ( %). what are the implications for public health practice? cdc collaborations with health departments have strengthened local capacity, assisted with outbreak response, and directly contributed to data-informed guidance, benefiting local and national response efforts. through medicare, as an effective containment strategy, based on collaborative work between cdc and health departments, including in king county, washington § § ( ). on july , tyson foods, the world's second largest processor of chicken, beef, and pork, announced it would expand weekly covid- testing and symptom monitoring among employees as part of a nationwide strategy to contain infections, per cdc guidance ¶ ¶ and after data analysis conducted in collaboration with state health departments ( ) . among total covid- -related reports published in mmwr up to the august th issue, ( %) resulted from these deployments. the findings in this report are subject to at least two limitations. first, deployment data could be subject to data quality issues, despite regular data reviews and a full review of individual deployment data for this report. second, this report describes deployments through the cdc covid- state, tribal, local, and territorial response section. health departments were also supported by other cdc covid- response sections, as well as by cdc staff members already working within state, tribal, local, and territorial departments of health, such as career epidemiology field officers, public health associates,*** and epidemic intelligence service officers. † † † in addition, during january -july , , cdc deployed staff members to u.s. quarantine stations and airports as well as staff members to support repatriation missions. § § § § § https://www.cms.gov/files/document/ -covid- -long-term-care-facilityguidance.pdf. ¶ ¶ https://www.meatpoultry.com/articles/ -tyson-expanding-covid- testing-monitoring-as-part-of-nationwide-strategy. *** https://www.cdc.gov/phap/index.html. † † † https://www.cdc.gov/eis/index.html. § § § https://www.cdc.gov/coronavirus/ -ncov/php/open-america/staffing.html. as the covid- pandemic continues, ongoing collaboration between health departments and cdc will aim to strengthen local capacity, assist with outbreak response, and, as new evidence emerges, directly contribute to data-informed guidance that will benefit local and national response efforts. cdc covid- state, tribal, local, and territorial response team corresponding author: emilio dirlikov, klt @cdc.gov updated preparedness and response framework for influenza pandemics -ncov cdc response team. initial public health response and interim clinical guidance for the novel coronavirus outbreak-united states washington state -ncov case investigation team. first case of novel coronavirus in the united states public health response to the initiation and spread of pandemic covid- in the united states trends in number and distribution of covid- hotspot counties-united states asymptomatic and presymptomatic sars-cov- infections in residents of a long-term care skilled nursing facility-king county serial laboratory testing for sars-cov- infection among incarcerated and detained persons in a correctional and detention facility-louisiana covid- outbreak among three affiliated homeless service sites update: covid- among workers in meat and poultry processing facilities-united states community transmission of sars-cov- at two family gatherings all authors have completed and submitted the international committee of medical journal editors form for disclosure of potential conflicts of interest. no potential conflicts of interest were disclosed. key: cord- -q wf au authors: olivia li, ji-peng; liu, hanruo; ting, darren s.j.; jeon, sohee; chan, r.v.paul; kim, judy e.; sim, dawn a.; thomas, peter b.m.; lin, haotian; chen, youxin; sakomoto, taiji; loewenstein, anat; lam, dennis s.c.; pasquale, louis r.; wong, tien y.; lam, linda a.; ting, daniel s.w. title: digital technology, tele-medicine and artificial intelligence in ophthalmology: a global perspective date: - - journal: prog retin eye res doi: . /j.preteyeres. . sha: doc_id: cord_uid: q wf au the simultaneous maturation of multiple digital and telecommunications technologies in has created an unprecedented opportunity for ophthalmology to adapt to new models of care using tele-health supported by digital innovations. these digital innovations include artificial intelligence (ai), th generation ( g) telecommunication networks and the internet of things (iot), creating an inter-dependent ecosystem offering opportunities to develop new models of eye care addressing the challenges of covid- and beyond. ophthalmology has thrived in some of these areas partly due to its many image-based investigations. tele-health and ai provide synchronous solutions to challenges facing ophthalmologists and healthcare providers worldwide. this article reviews how countries across the world have utilised these digital innovations to tackle diabetic retinopathy, retinopathy of prematurity, age-related macular degeneration, glaucoma, refractive error correction, cataract and other anterior segment disorders. the review summarises the digital strategies that countries are developing and discusses technologies that may increasingly enter the clinical workflow and processes of ophthalmologists. furthermore as countries around the world have initiated a series of escalating containment and mitigation measures during the covid- pandemic, the delivery of eye care services globally has been significantly impacted. as ophthalmic services adapt and form a “new normal”, the rapid adoption of some of telehealth and digital innovation during the pandemic is also discussed. finally, challenges for validation and clinical implementation are considered, as well as recommendations on future directions. consolidation of tele-health, the development of th generation wireless networks ( g), artificial intelligence (ai) approaches such as machine learning (ml) and deep learning (dl), and the internet of things (iot), as well as digital security capabilities such as blockchain, have created an extraordinary ecosystem for new opportunities in healthcare and other industries ). these developments could potentially address some of the most urgent challenges facing health service in , who started developing a framework for the adoption of digital innovations and technology in healthcare. the who recommendations on digital interventions in healthcare promotes assessment on the basis of 'benefits, harms, acceptability, feasibility, resource use and equity considerations', and views these tools as still very much that -tools -in the journey to achieving universal health coverage and sustainability (world health organisation ). there are several digital interventions that have been prioritised for review by the who. of relevance to this discussion are: the use of client-to-provider telemedicine to complement health service delivery; the use of provider-to-provider telemedicine; targeted customised health information transmission; health worker decision making support; digitised health information tracking; and education. in all these scenarios, the review highlights the need for monitoring of patient safety, privacy, traceability, accountability and security, with plans in place to address any breaches. processes for these have been innate within the pharmaceutical and other medical devices industries, and new technological entrants to this traditional sector should consider these during development of the services. there will also be ethical conundrums that have yet to be articulated and debated. the engaged clinician should seek to be involved in the development of these new advances to closely align any innovations to solve unmet clinical needs. simultaneously, clinicians should examine if any innovation complies with quality, ethical, and sustainable healthcare, as legislation invariably lags behind such momentous leaps in innovation. telemedicine enable clinicians to evaluate their patients remotely. this can be desirable for several reasons. first, telemedicine can facilitate more efficient and equitable distribution of limited healthcare resources. this allows delivery of care to distant areas where there is a shortage of doctors and other professionals, reduces travel and the associated carbon footprints, and connects patients with rare diseases to speciality care and address the transport challenges some patients face. waiting times could be reduced through increased capacity and access to care for both chronic and acute disease patient. in the acute setting, patients could receive immediate specialist input even if one is not available locally. second, amid the covid- pandemic and in mitigating infection risk in the healthcare setting, real-time telemedicine has been rapidly incorporated into routine care delivery. the patient population telemedicine aims to serve is no-longer focused on targeting remote regions. instead it is rapidly becoming a new standard of care. it enables triaging prior to patients' arrival into hospital to avoid unnecessary visits and exposure risks and has been adopted by multiple centres across the world j o u r n a l p r e -p r o o f (hollander and third, video-consultations in combination with innovative service design already exist that further limits patient journeys and clinic visits whilst maximising the quality of the telemedicine consultation. in scotland, optometric practices have been set up strategically across some regions to provide primary eye care services (nhs scotland ). smart phones attached to slit-lamps enable ocular biomicroscopic videography, empowering ophthalmologists to view the patient's examination features in real-time without the patient attending. also, simplification of image sharing of data such as oct scans can be achieved by screen sharing, which has long been a challenge both within ophthalmology and in radiology due to the variety of available formats and software. devices such as tonometers may be prohibitively expensive. effective tele-screening programmes require multiple components. first, there should be a reliable, cost-effective and operator-friendly data gathering system. a preferred goal is to achieve longitudinal consistency of data format to facilitate comparisons. the device itself should be simple, with mechanisms in place to facilitate data transmission to the iot. ideal designs should involve networks where multiple, simpler devices can communicate with a central station. system updates would involve the central stations to enable streamlined logistics and cost efficiency, particularly if the network has widely dispersed simpler devices. second, the data must be processed and enabled to identify the disease of interest. the most frequently adopted model at present is the use of trained persons to read the collected images, as in diabetes tele-retinal screening programmes. whilst larger numbers can be screened this way in comparison to direct clinician reviews, it remains a costly and resource intensive process involving highly trained graders. while dl is starting to be incorporated to this process, the potential benefits from this adaptation are unknown. regulatory bodies recognise the potential of ai in healthcare, and the fda has approved the use of an ai algorithm for the diagnosis of dr in the primary care setting (abramoff et al. ). finally, the outcome must be conveyed in a timely manner to the patient and the healthcare provider to facilitate appropriate medical management. this communication again could involve a clinician consultation, but most normal outcomes may be communicated in an automated manner such as via a smart phone app or text message. j o u r n a l p r e -p r o o f beyond simply replicating current services albeit remotely, the collection, storage and transmission of offer the potential of combining telemedicine with ai. when used prospectively with longitudinal data, vast swathes of new knowledge such as disease progression and real-world, real-time incidence calculation could be harnessed. if well adopted, the data collected would enter the realms of big data, and far exceed the capabilities of data capture that most individual studies are able to achieve. moreover, this could grow into a consistent source of longitudinal data which would be valuable in the development of disease progression forecasting capabilities, incorporating ai. . th generation ( g) telecommunications g wireless communications was designed to meet the challenges of serving large- scale complex network connections. these networks have extremely low latency, higher capacity, and improve the speed of data transmission through the use of higher frequency millimetre waves compared to existing networks (simko and mattsson ). latency in g transmission can be less than millisecond of delay compared to about milliseconds on the g network, and give significant improvement to the users' perception of the service (samsung ) . download speeds on g networks can be increased fold from the current gigabit per second on g (nordrum, clark, and staff. ) . and all this magnitude increase in function whilst simultaneously reducing energy consumption by the connected devices (agiwal, roy, and saxena ). g networks will deliver an end-to-end latency of less than milli-seconds and over-the-air latency of less than one millisecond -which is one-tenth of the g network latency (samsung ) . g utilises small cells, which are miniature base stations that have low power requirements. however, because g transmits at higher frequencies, signal attenuation becomes a greater challenge, and these base stations need to be placed closer than g base stations (every meters or so) (national academies of sciences et al. ). to ensure consistent signal transmission, base stations will need to be densely populated. despite the base stations being smaller in size, the increased infrastructure needs of a g network with these cells will not be practical in sparsely populated rural regions. thus whilst telemedicine has been traditionally regarded as being able to contribute to healthcare delivery to these areas in a meaningful way, it may in fact continue to exclude those who already struggle to access physical care. in addition to being able to support increasing bandwidth demands from users and patients, g enables ultra-high-definition (uhd) multimedia streaming with enhanced user experience. the high-resolution images can be more easily transferred. better quality and reliable video-consultations with improved patient experience may contribute to forging better physician-patient relationship. real-time slitlamp examinations streamed in high-definition has the potential to become j o u r n a l p r e -p r o o f common place. with imperceptible latency, the clinician could control a slit-lamp remotely whilst looking at a mobile device displaying the eye being examined remotely. the immersive experience promised by g can also be used to augment the learning experience, particularly the visually-based tasks such as surgery. despite these great expectations, g will not be the panacea for all connectivity challenges. the reported speeds assume that every network is using g, but not surprisingly the implementation of g will be gradual as new cells are built and installed. this incremental adoption of expensive infrastructure means that the network will need to remain compatible with legacy networks, and with other operators who may be implementing at a different speed (rashid ) . in being compatible, and with the networks essentially being a patchwork of wireless connections incorporating various generations, the same vulnerabilities found in older generation networks will remain. well-knowns flaws of the data packet transmission protocol that is used across the different generations of networks, the general packet radio service (gprs) tunneling protocol (gtp), include not validating users' physical location permitting attackers to spoof locations and allowing attackers to impersonate other users or use false credentials, so the impersonated subscriber is charged for costs incurred. attackers can block all connections stemming from a single node so legitimate subscribers cannot access a connection in the given geographical region, in a denial-of-service attack (rashid ). the most basic requirements of connectivity in healthcare are security and reliability, and despite the impressive numbers g promises, it may be still some time before these two basic tenets are consistently achieved. . . g and the covid- pandemic the lockdown orders across the world has brought a sudden strain on existing cellular networks. as countries responded, work, education, healthcare, and most other human interactions were suddenly pushed onto the virtual arena. the pandemic has shown that telemedicine is not only reserved for the remote and underserved. in fact, telemedicine can routinely serve the wider population if it can be shown to be safe, efficient, and inclusive, with measures to ensure security, robustness and capacity, particularly in densely populated regions with massive competing demands for bandwidth. though few examples currently exist, g telemedicine has already been implemented. in china, the successful utilisation of a g telemedicine network was reported in sichuan province (hong et al. process is time-consuming and costly, but also makes ophthalmology one of the specialities particularly well-suited to dl techniques and its real-world application. the application of dl to ophthalmic images, such as digital fundus photographs and visual fields, has been reported to achieve the automated screening and diagnosis of common vision-threatening diseases, including diabetic retinopathy (dr) ( healthcare is notably slower. there is a real risk that high hopes for the new technologies described elsewhere in this paper will flounder upon the reality of healthcare systems that remain digitally immature. some barriers to innovation in healthcare are perfectly legitimate, for example the real risk that sub-optimal deployment of a digital technology could lead to patient harm. other barriers are entirely artificial, and foremost among these are the perverse incentives created by billing and tariff systems. in the uk, for example, there has only recently been a move to correct the imbalance between poorly reimbursed remote consultations and well reimbursed face-to-face consultations (brennan, serle, and clover ). when a technology has successfully navigated the ethical, financial, regulatory, and safety barriers to implementation in healthcare, the rate of attrition remains high. in order to be scalable beyond local pilots, the technology must either fit in seamlessly with existing clinical practice, or it must be sufficiently compelling to cause clinical practice to change (as we have seen with oct platforms in ophthalmology). the failure of the uk's national programme for it is a case study for this phenomenon(robertson, bates, and sheikh ). where local adoption has been successful, innovations can be slow to spread through a fragmented system, with funding for spread of innovation often a small fraction of the research and development budget (collins ) . a partial solution to these challenges has been the creation of innovation units embedded in hospitals and academic medical centres (e.g. cleveland clinic innovations and the digital clinical lab at moorfields eye hospital). these units can help to develop digital technologies that improve healthcare delivery in the real world, rather than developing solutions that can't easily be incorporated into routine practice. while innovation units can earmark resources, a major enabler is their ability to bring together multi-disciplinary teams that allow the development of useful solutions. these include, among others, engineers, developers, behavioural scientists, intellectual property specialists, and clinicians. the development of local capabilities to drive digital innovation mirrors the acceptance that national initiatives, such as emr deployment, can be more successful when driven from "bottom up" process whereby local solutions are integrated in a modular fashion (aanestad and jensen ). a key enabler to this modular approach to innovation is the adoption of shared interoperability standards. without these standards, we run the risk of creating a complex ecosystem of technologies that are incapable of communicating with each other. ophthalmology is particularly retrograde on this, with most devices using vendor-specific file formats. vendor-neutral approaches will improve the ability of ai algorithms, for example, to work on a common data substrate. these standards have long been suggested, but we are now beginning to see concerted effort towards their adoption, for example smart-on-fhir, a standards-based interoperable apps platform for ehr (mandel et screening programmes, whilst also utilising the data generated during the screening process to aide in the further development of existing and new algorithms. figure demonstrates the electronic systems that are already in place to streamline the management of a patient's journey, with virtual integration of each step of their journey from registration to ehr to management of images. myriad dl programmes are being developed for dr diagnosis, with several models evolving into clinical adoption. training datasets and diagnostic performance for optic disc pathology using oct. the widespread availability of such an algorithm could extend the utility of fundus images acquired in non-ophthalmic centres. compared to optic disc images, vf data are characterized by low dimensionality and high noise, and such datasets could be refined using unsupervised ml algorithms. the two most reported unsupervised algorithms are clustering and component analysis ( the most intractable problem of treating amd is the frequent and time-consuming appointments requiring review, evaluation and possible subsequent intravitreal injection. since amd treatment is determined mainly from the va and oct findings, telemedicine could be as useful as face-to-face office consultation. a meta-analysis in suggested that teleophthalmology for amd is as effective as face-to-face examination, and potentially increases patient participation in screening ( in , the first prospective randomized study to assess the efficacy of telemedicine for both in the initial screening and recurrence monitoring of neovascular amd was reported in canada (li et al. ) . best corrected visual acuity, iop, color fundus photography, and macula oct were incorporated in a "store and forward" telemedicine model. those in the telemedicine arm attended a local ophthalmologist who performed the screening, and the data was stored on a database, which was then reviewed electronically by a retina specialist. in those referred for initial screening of neovascular amd, there was no statistically significant difference in patient waiting times to further diagnostic tests and to treatment. there was also no significant difference in patient satisfaction except for parking issues. in those monitored for recurrence, there was no significant difference in the visual outcome between groups ( / . vs. / . , p= . ). this "store and forward" model still utilizes an ophthalmologist as the initial screener. while a technician can be for initial data acquisition used for screening, telemedicine can be applied further so that initial screening and subsequent monitoring can be remote, out of the clinical setting and into the home. home monitoring and self-care have taken centre stage in modern medicine. remote in-home monitoring is currently practiced to monitor acute and chronic diseases such as body temperature to assess a upper respiratory infection, blood pressure for hypertension (noah et the alleye tm application ( figure ) , which similarly tests hyperacuity, but examines a larger area of the macula ( degrees compared to degrees of field) has demonstrated its ability to detect neovascular amd and discriminately classify between dry and wet disease ( prove to be important during pandemic as well as in the future to limit in-person visit only when needed. the use of telemedicine for amd in the united states has centered on amd screening and remote-monitoring systems with some utilising artificial intelligence applications but as yet there are no large-scale programs for either screening or monitoring of amd (brady and garg ). there are unique challenges to the screening and monitoring of amd with lack of consensus on the suitability of the disease for population screening, and the need for octs rather than simple fundus photographs as used in dr screening and ai algorithms (brady and garg ). the mayo the virtual clinics accounted for approximately % of amd service appointments. with the introduction of the virtual clinics, patients were followed up with a mean of . weeks compared to . weeks in the period of conventional clinics. refractive error is a key public health concern with more than million people suffering from insufficient or no refractive correction globally (global burden of disease study ) with the incidence of myopia increasing and poised to escalate further with urbanization and higher literacy rates (pan, ramamurthy, and saw ). adding to this, the optometrist to population ratio is : , in high-income countries and : , in low and middle-income countries (di stefano ). to evaluate refractive error, traditional visual acuity examination is time-consuming, and requires the availability of equipment, and examiners skilled in the art of prescribing spectacles. the procedure is also challenging for people with difficulty in expressing themselves, such as young children, the elderly, and patients with verbal costly investments for its equipment as well as the hiring of experienced examiners. consequently, economic implications due to incorrect dispensing remain high even in developed countries (vitale et al. ) . providing good quality refraction services acceptable to the general population is greatly needed. while myopia alone increases the risk posterior segment complications, these risks are notably increased in pathologic myopia (pm) when potentially blinding posterior segment pathological changes appear as a result of the globe elongation (grossniklaus and green the focus of tele-myopia has been on to prediction of refractive error from easily obtainable and consistent methods proven in other disease; namely, using the acquisition of fundus photographs. to be able to accurate define refractive error to enable a prescription that is acceptable to the patient would be a significant leap forward in solving the burden of refractive error. several advanced techniques that assess refractive error accurately have been developed, and patients were found to be sufficiently motivated to report their symptoms at least once a month with a good correlation between the two dry eye questionnaires (r= . ), underscoring the potential utility of a tele-health approach for monitoring telemedicine presents different challenges in comparison to screening. screening is repetitive and elective, and the process can be planned with clarity for the input, processing and outputs. for diagnosis, on the other hand, a telemedicine diagnostic service must consider a much wider variety of conditions and include more abnormal conditions. in addition, it is more challenging to streamline and process input data in manner that achieves high diagnostic accuracy. achieving such accuracy requires highly trained personnel. clinical agreement between the clinical and e-diagnosis, high ( %) patient satisfaction, and % reduction of unnecessary referral to the hospital eye services. moreover, the referrals (with digital images if necessary) were processed within hours, enabling a timely triage and management of any urgent and sight-threatening diseases. when this programme went live throughout southeast scotland, the referral-to-consultation waiting time was reduced from weeks to weeks. the foundation of this integration project enabled the safe delivery of eye care services during the covid- pandemic with many primary and urgent eye care services enabling non-hospital patient care (nhs scotland ). a cloud-based referral system in the uk has demonstrated that more than half of referrals for possible retinal pathologies to hospital eye services from optometrists could be avoided with a consultant ophthalmologist reviewing fundus photographs of the referred patients (kern et al. ), similar to the pathway shown in figure . although there are still many factors to be addressed such as safety, economic benefit, patient satisfaction, and outcomes for those patients who were not referred, there are notable advantages such as timely patient triage, enhanced provider correspondence and education. this system enabled the referring doctor to be able to receive the patient outcome via the platform, allowing each case to be an educational opportunity. the safety of remote triage in emergency ophthalmology still needs to be demonstrated. one early study showed that of patients who were triaged remotely in an emergency unit, % had delayed treatment due to misdiagnosis (bourdon et al. ). prior to widespread adoption of tele-triage, the potential for harm needs to be more accurately characterised as well as mechanisms put in place to mitigate the shortcomings of remote reviews. since in the absence the visual isolation of cases in an effort to stop transmission. with the mitigation approach, the study found that of people may still be affected, resulting in , deaths in the uk and . million deaths in the us by the end of the pandemic. the study suggested infected cases could be significantly decreased with a suppression strategy ("lockdown"), which involved closing schools/universities, case isolation, household quarantine and social distancing. as country after country began imposing "lockdown" measures, including quarantines and travel bans in an unprecedented scale (parmet and sinha ). other specialties, telemedicine was employed to follow-up routine patients, and to triage and manage new patients presenting to ophthalmology departments. telephone consultations alone could suffice for some patients, but the addition of video features allows the clinician additional information to more appropriately triage a patient. live video information can be particularly useful in specialties such as oculoplastics (kang et al. ) and strabismus, but also in external eye diseases where corneal infiltrates may be observed. furthermore, telemedicine allows for non- verbal communication and aids in fostering physician-patient engagement. effective triage not only keeps many patients out of the hospital but can also shorten the patient's journey once they arrive in hospital. a patient with classic symptoms of a retinal detachment may bypass the emergency department and be referred directly to a vitreoretinal surgeon. the rapid introduction of telemedicine and teleophthalmology during the pandemic has moved beyond the traditional model of connecting specialists with patients from remote and underserved regions. instead it has the potential to become the new standard of care, in particular for triaging patients prior to their hospital attendance. the new telemedicine systems replacing routine care needs evaluation to ensure patient safety. governments such as the china and the us have taken steps to facilitate the rapid upscaling of these services, with the chinese national health insurance agency covering virtual consultation fees, and the us centres for medicare and medicaid services (cms) implementing temporary waivers to enable flexibility within the healthcare system (webster ). the manifold surge in uptake reported by cms is staggering: nearly . million beneficiaries receiving telehealth services in the last week of april, compared to around , beneficiaries a week prior to the pandemic (verma ). of the million beneficiaries who used a telehealth service three months from mid march , % were conducted over the telephone suggesting there is still significant work to be done in terms of telecommunications network, healthcare facilities and clinicians adopting new applications, and consideration of patient factors. as countries consider the model of eyecare in the post-covid- "new normal", there are several key considerations (table ) . first, services must allow for sustainable social distancing measures for protection of patients, staff and the public. second, those at high risk of serious morbidity and mortality with covid- should be facilitated to isolate wherever possible with access to services at home. third, plans must be in place for the management of patients who develop eye conditions concurrently with covid- . fourth, contingency to manage the 'surge' of patients who have had deferred appointments or presented late as a result of "lockdown". fifth, services should have the agility to expand and shut down to essential provisions responsively in preparation for future peaks of covid- , and indeed other future pandemics. finally, there should be measures in place to continually assess the outcomes of these services to ensure quality of care. the covid- pandemic has come at a time when many technologies and the necessary infrastructure are mature and already established. much can be achieved with simple and universally available technologies such as telephones, messaging, and video-calling, albeit via safer and secure applications. subsequently, more sophisticated eye examinations via telemedicine can occur. this pandemic has significantly altered the landscape of health care delivery and may have permanent implications. time is still needed to establish the safety telemedicine on a massive scale, but the paradigm shift in acceptability to both patients and doctors will be profound. aside from the technical and infrastructural challenges, there are concerns over how patients will respond to such a shift in healthcare delivery, and if the loss of rapport gained from physical interaction will cause harm. clinicians are also discovering that face-to-face healthcare delivery in the post-covid era has also changed. face masks and social distancing result in loss some of the non-verbal communication, impede the delivery of empathy. though there is physical distancing over a video-consultation, patients are able to see their doctor, and both are able to see the facial expressions of the other. acceptance in both patients and physicians is on the increase (pappot, taarnhoj, and pappot ; hao ). even when teleophthalmology services have been rapidly adopted during the pandemic, feedback from a prospective study of patients in an oculoplastics service reported % preferred the video consultations to face-to-face, and in this group ranging from years to years (mean . years), % would recommend video consultation to others (kang et al. it would not be possible to provide care at pre-covid- levels whilst practicing social distancing and maintaining a safe environment for patients and staff alike. new models of care are being and need to continue to be rapidly upscaled to enable safe delivery of care until an effective vaccine or treatment is found for covid- . the overriding principle of safe care in the covid- in ophthalmic practice is minimizing exposure: mainly by reducing the number and duration of in-person clinic visits. assessments, tests, consultations and even pharmacy and interventions need to be minimised to those essential for safe care. the integration of teleophthalmology will be fundamental and can be utilised at multiple points of a patient's eye care journey. telemedicine can be and already is being adopted for strabismus. figure provides an example of semi-automated remote triage workflow for emergency ophthalmology. non-ophthalmologist health care workers including optometrists, nurses and technicians should be trained in multiple skills if possible so that a single person may perform several tasks such as assessment of visual acuity and intraocular pressure, instead of patients moving through a number of different clinical staff each performing a specific task. this improves efficiency and limits exposure risk. furthermore, integrating second opinion services to primary care and optometry practices may enable more appropriate referral into specialized eye units. these measures protect patients and health care workers and contribute to the larger public health measures. telemedicine also enable ophthalmologists in isolation to continue to contribute in clinical work and lessen the impact of key staff shortages. this current climate provides the perfect ecosystem to reassess care delivery and to adopt the synergistic and complementary digital technologies discussed above, incorporating teleophthalmology and ai utilising and facilitated by g networks, iot and big data analysis. there is widespread media interest and raising of public awareness of the role telemedicine has already started to play in risk mitigation during the pandemic. the emergency department may be a good candidate for widespread introduction of virtual triage prior to attending in person. the patient benefits as they may discover they do not need to attend in person, and can be treated with medicines prescribed remotely. if they do need to attend, their in hospital journal may be much more efficiently managed, being seen directly by the specialists if appropriate. additionally, with the maturation of chatbots, much of the patient counselling can be done seamlessly from the video consultation. the healthcare providers too reap the benefits of reduced in person attendance, costs associated with additional time and space utilisation, as well as use of personal protective equipment at a time where sustainability must also always be considered. staff who are able to work from home can contribute, facilitating efficient use of human resources. reduced attendances also reduces the general workforce risk of covid- , avoiding the highly undesirable scenario of transmission between clinicians and patients. safety of such systems, the remote triaging and automated counselling need to be evaluated, and until then, clinicians need to oversee each consultation as is standard process prior to the pandemic. the figure below demonstrates how a virtual video-based triaging system, with semi- automated features such as registration and counselling, might work. when patients register, there can be early algorithmic assessment of their presenting complaint. symptoms such as flashing lights and floaters, new binocular double vision and new anisocoria will invariably require in-person examination, and as such can be directed early to a physical appointment without the patient waiting for a full virtual assessment first. patients who do not necessarily require clinician input, such as mild dry eyes or chalazia, or followup patients who have seen resolution of their symptoms, for example treated pre-septal cellulitis or contact-lens related keratitis, can be directed to a chatbot or video for discussion. the remaining patients will be connected to a clinician when can proceed with a full history and basic examination which may involve visual acuity assessment using web-based tools. for conditions that may be managed remotely, such as early pre-septal cellulitis, mild recurrent anterior uveitis or indeed early non-vision involving contact lens associated keratitis, medication can be prescribed and sent to the patient via a dedicated delivery service or local phamarcy. if necessary, plans can be made for the patient to attend in person for review. digital transformation through the adoption of teleophthalmology and ai is more than simply buying new software and hardware, and the next section explores some of the key challenges to be overcome. real-world validation has proven to be challenging. the size and heterogenous nature of the digital health sector with its constant and rapid evolution has created a complex environment for physicians, healthcare providers, patients and regulatory bodies in assess these tools to address unmet clinical needs (mathews et al. ) . there is a need for a rigorous and transparent validation framework, which has some flexibility in being applied to a broad range of technological innovations. one proposed framework suggests evaluation based on technical and clinical considerations, usability, and cost (mathews et al. ). technical evaluation is the most obvious, and is the first step to validation. this is the fundamental aspect of the technology, and should address if the technology performs its purported function, its accuracy and robustness. for example, does a video consultation platform enable patients to register to a virtual waiting room and be connected to the appropriate clinicians in a safe and effective manner, with due consideration for data protection. clinical validation approaches should reflect those that are well established in clinical research, but can be tailored for digital technologies. such studies are still uncommon and may be at least in part due to the lack of clinical experts simultaneously engaged with technological advances (hatef, sharfstein, and labrique ) the cost of prospective clinical trials as a comparison to existing gold standards may be off-putting for some in the technology sector who seek rapid product cycles and returns. usability, and also accessibility, and the intended user of the technology must be assessed. clinicians may need new skills in order to effectively use the tools. the effectiveness of their use by patients unsupervised should be assessed, as well as consideration of those who face barriers in adopting the technologies. cost, and cost effectiveness, as well as the longer term costs should be estimated. costs may be obvious, such as purchasing the rights to an algorithm, or hidden, such as increased referrals seen through telemedicine screening services. implications for all stakeholders needs to be considered, from the patient to clinician, to funding bodies as well as the state. regulatory bodies attempt to provide guidance for users and payers. workflow disruption and security and privacy concerns (ajami and bagheri-tadi ). some of these issues might be potentially overcome with education and training of the end-users and provision of financial incentives by the government for meaningful use of ehr system (patel et al. (patel et al. ). (patel et al. after validating the technological and clinical performance, cost-effectiveness represents the next hurdle to be overcome before the implementation of a specific tele-health programme. a notable example was reported in the uk where a large randomised controlled trial in england evaluating the cost-effectiveness of tele-health intervention for long-term conditions (including heart failure, chronic obstructive pulmonary disease, and diabetes) demonstrated no additional benefit when compared to standard care (henderson et al. ) . that said, tele-ophthalmology intervention, particularly for dr screening, has proven to be a cost-effective approach and is already being implemented in many countries, including the us, uk, and singapore, at nationwide levels (kirkizlar et orbis international uses a free online ophthalmic telemedicine program partnering doctors in developing countries with expert mentors internationally (prakalapakorn, smallwood, and helveston ). in a survey of this offering, they reported e- dl algorithm uses the "black box" approach where clinical features that confirm a diagnosis are not apparent. to underscore the reasons prompting a specific diagnosis by algorithms would be highly beneficial as it allows for clinicians to understand assess if the correct features were identified, and to offer new insight into diseases not previously known. this lack of explainability is a hurdle both for clinician and patient trust. it is challenging when there is disagreement between the algorithm and the patient and root cause analysis stops short. it is not possible to know if there is an inherent error in the algorithm that might be corrected. processes need to be in place such disagreements, such as an independent third party of a multi-disciplinary team meeting as would occur where there is clinical uncertainty. there needs to be recognition though, that ai may be proven to be more accurate than a physician, and detect features humans cannot, as demonstrated by an algorithm being able to identify sex from fundus photographs (poplin et al. ). thus it becomes harder to adjudicate between the clinician and ai, when the adjudicator will invariably be another clinician, in particular if the ai decision making process is unexplainable. in these cases, it may become unethical not to use ai, even though we do not fully understand how they work. it is unlikely though, that an individual algorithm will be able to replace the holistic role of a physician, and increasingly the role of the physician could evolve the use of ai for specific tasks, and digest the various outputs to collectively to manage the patient. education on the use and appraisal of ai systems should be incorporated into medical school programs, and clinicians already in practice will need training to facilitate its adoption when the technology reaches maturation for clinical practice. technically able staff who would not form part of existing human resources will need to be recruited, and work with clinicians to champion adoption. in cases of poor image quality, automated processes may be able to enhance those images and enable their reading by the algorithm. however, those with residual artefacts will remain ungradable and require referral to a clinician. early ai algorithms were tested on images collected in the clinical trials setting with strict inclusion and exclusion criteria (burlina et al. with the rapid advancement in digital technology, including ehr, smartphone and g/ g technologies, tele-health is likely to pave the way for assessment and management in the field of ophthalmology. in order for a comprehensive and robust teleophthalmology platform to thrive, a well-planned eye care delivery system must exist that considers the resources that are available in specific regions. in , the aao telemedicine task force published an information statement regarding the development and implementation of teleophthalmology, including validation of a teleophthalmology programme against a reference standard, requirement and standards of data acquisition and communication devices, competency and qualification of involved personnel, quality assurance, and data protection (american academcy ophthalmology (aao) telemedicine task force ). in principle, it is recommended that a tele-health programme should be implemented and integrated with evidence-based clinical practices where traditional process of care is already established (american academcy ophthalmology (aao) telemedicine task performing the specific given task. the replicability of these frameworks may also vary from country to country due to cultural differences. understanding the prevalence of the common ocular diseases at a national public health level, country-specific, is paramount as it helps policymakers and relevant stakeholders to maximise the cost-effectiveness of the tele-medicine programmes by targeting highly prevalent diseases. in addition, common diseases that are dependent on image-based diagnosis with universally agreed-upon, evidence-based classifications (e.g. dr, amd, glaucoma and cataract) should also be prioritised in the set-up of teleophthalmology programmes. the data derived from tele-health may also be harnessed to generate big data research and to offer more diverse information such as patient journey education and disease progression forecasting (mccall ). aspiring to health equality and protection of vulnerable groups should be a key consideration in every stage of digital innovation and implementation. the existing digital technologies are predominantly focussed on diagnosis. ai of the future can increasingly play a role in the guidance of treatment, such as prediction of how likely patients are to respond to treatments such as intra-vitreal injections in wet amd or dmo. increasing use of ai in the prediction of refractive outcomes following cataract surgery can help refine lens selection. for children requiring patching or those requiring accommodation exercises, digital solutions may be able to help adherence to treatments, with gamification and introduction of incentives for compliance, although debate will exist around if such use of technology is desirable for children. recently, ml associating perimetric cone sensitivities to local oct in patients with retinitis pigmentosa was applied to predict visual function in lebers congenital amaurosis (lca) (sumaroka et al. ). though the training dataset was small, cone vision improvement potential in some lca was shown to be predictable. this may permit individual prediction of likely response to treatments and influence selection to clinical trials so that those with maximal potential gains are selected. increasingly, isolated algorithms will integrate data from across modalities, and across disciplines. the utilisation of multi-modal imaging is important for specific diagnosis (for e.g., determination of the neovascular amd subtype, diagnosis of glaucoma and etc). multi-modal machine learning can be used to evaluate whether the predictive or diagnostic power of the ai algorithms will increase with the addition of more imaging modalities. additionally, data from history, and other metrics such as blood pressure hba c can be used to increase the predictive power of the algorithms, and data collected from other specialities such as endocrinology and rheumatology could contribute. multi-modal inputs may be help improve the diagnostic and predictive power of ai systems, and move closer to simulating the decision-making process of a clinician, but deployment of such multi-modal algorithms in the real-world setting can be difficult. if the ai has been trained using the ground truth generated by a multi-modal imaging and additional biomarkers but during clinical use only a limited data is collected, then that algorithm may not be applicable. therefore a balance needs to be achieved between what is practical for routine clinical use versus a complex algorithm that incorporates multiple inputs. ai may also play a role in interpreting genetic diseases, such as those with variable expressivity and phenotypes. dl has been applied in genomics but still remains in its infancy. there have been studies that have shown some success with various - challenges exist, such as the lack of explainable ai, balanced datasets representing both disease and healthy states, and integration of heterogeneous data, which is akin to some of the challenges presented by multi-modal algorithms discussed above (koumakis ). medical schools and medical training programmes also need to adapt and incorporate understanding of digital innovations into training. clinicians should learn to interpret studies on areas such as ai or dl algorithms (ting, lee, and wong ) to know if and when such technologies would be suitable for their practice. medical students should also learn to conduct remote consultations, be that video or telephone based only. without the patient being physically present, the focus of consultations changes somewhat with the importance of excluding pathologies that require in person assessment rather than simply managing the presenting complaint. nuanced changes to communication strategies need also to be developed adapted for virtual consultations, and clinicians need to develop at least some basic understanding of the technical aspect of each platform to enable simple trouble- shooting for new users. finally patient attitudes need to be studied whilst recognising these will evolve, as any reaction to something novel. education driven by evidence and not politics or other motivations, communicated effectively to reach a wide audience will be crucial in influencing patients to make their own considered decisions. conclusions myriad innovations have created a milieu ripe for telemedicine in ophthalmology to thrive and covid- has hastened the development and embracement of these digital technologies. the growing ai and telecommunications technologies can potentially transform the delivery of the data-rich and image-dependent specialty of ophthalmology globally. g, iot and ai are starting to be introduced into ophthalmology, but the potential for reliably linked machines such as octs and fundus cameras and algorithms changing ophthalmic service delivery is significant, and is likely to become more prevalent as the g network coverages grows, enabling a more mature iot. these technologies may be able to make key contributions towards the provision of quality, sustainable eye care to all patients, and experiences from the pandemic has revealed the utility of telemedicine even in well-resourced and densely populated. challenges associated with implementation of these technologies remain, including validation, patient acceptance, and education and training of end-users on these technologies. physicians must continue to adapt to the changing models of care delivery, and collaborate with broader teams involving technology experts and data scientists to achieve universal quality and sustainable ophthalmic services. the dash box refers to automated pathway, which could proceed without an ophthalmologist reviewing the case and images. example of 'simple' case: dry amd diagnosed and recorded but no clinical action required and clinician oversight not required. example of 'complex case: macular hole potentially suitable for surgery, with clinician alerted and further clinical decision to be made. table . countries, their national screening strategies and the adoption of tele-screening and artificial intelligence in diabetic retinopathy screening. were well received by users, with % of users wishing to continue its use, and % of the not using the system wishing to do so. whilst success in terms of patient and physician satisfaction has been demonstrated with this 'store- and-forward from a medicolegal perspective, physician-patient interaction in tele-health is currently considered the same as face-to-face consultation. though physicians are concerned about missing a diagnosis or finding (due to inadequate medical information or suboptimal image quality), the digital images used could serve as a powerful objective evidence of the consultation. another noteworthy aspect is that laws governing physician-patient interactions are disparate across states and countries. having an overarching regulation of telemedicine would expedite the introduction and implementation of telemedicine in routine healthcare service regulation of telemedicine is also evolving. the centres of medicare and medicaid cms) broadened provision of telehealth services as part of the emergency response to the covid- pandemic to enable provision of care whilst limited community spread of the virus . challenges in clinical deployment of ai ai has remained largely constrained to the research domain with few examples of real-world adoption in ophthalmology and healthcare more generally. there are many 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'detecting glaucoma based on spectral domain optical coherence tomography imaging of peripapillary retinal nerve fiber layer: a comparison study between hand-crafted features and deep learning model key: cord- -fsj dg authors: patterson, grace t.; thomas, lian f.; coyne, lucy a.; rushton, jonathan title: moving health to the heart of agri-food policies; mitigating risk from our food systems date: - - journal: glob food sec doi: . /j.gfs. . sha: doc_id: cord_uid: fsj dg our food systems are progressively more industrialized and consolidated with many modern food value chains involving multiple countries and continents, and as such being associated with changes in risk profile and impacts of emerging and re-emerging diseases. disease outbreaks that sweep through a single region can have massive impacts on food supply, while severe outbreaks of human pathogens can disrupt agricultural labor supply or demand for products perceived as ‘unsafe’. market pressures have generally rewarded production of cash crops for fuel and energy dense, low nutrient processed foods over production of fruits and vegetables for local consumption. climbing rates of food-related ncds and pre-existing conditions leave the population increasingly susceptible to infectious diseases that are often driven by or arise from the food system. therefore disease and diet from our food systems cause impacts on human health, and human health issues can impact on the functioning of the food system. the covid- outbreak is the most recent example of food system driven disease emergence and of massive supply and demand shocks in the food system, experienced as a direct and indirect result of this disease. the effects of the food system on disease spread (and vice versa) must be addressed in future plans to prevent and mitigate large scale outbreaks. health policies must acknowledge the food system as the base of our health system, as must agri-food policy recognize the pre-eminence of human health (directly and indirectly) in decision making. the health of the global population is underpinned by our food systems, yet these systems are often only nominally included in health policy. in recent times, attention has been given to reformulation and marketing policies in moderate attempts to reduce climbing rates of obesity and non-communicable diseases (ncds) (oecd, ) . others focus on reducing foodborne pathogens by regulating processing and enacting trade restrictions (trienekens and beulens, ) . many of these policies focus on downstream actors and processes in the food system and neglect the foundations of how our food is produced. while such interventions are easier to enact, they have limited effects on health and are generally reactionary and insufficient to reverse the trajectory of increasing health burdens. in this manuscript we review some of the major human health externalities driven by our current food systems, with an emphasis on livestock-systems and their linkages to the wider food system, the impacts of our response to these externalities and outline key areas in which better integrated health & agri-food policy may mitigate these factors. although the interactions between food systems and our health are many and complex, we outline here four key health externalities arising from these systems of concern across the globe; ) the dual burden of malnutrition, ) foodborne disease, ) antimicrobial resistance and ) emergence of novel pathogens. despite an increasing ability to produce sufficient calories for the growing human population, distributional inequalities have produced a situation where we face the dual burden of chronic under-nutrition (black et al., ) and a global pandemic of overweight and obesity and related ncds, often within the same geographical locality (shrimpton and rokx, ) . diet related risks are estimated to be responsible for million ( - mn) disability adjusted life years (dalys) a year globally, and dietary improvements could potentially prevent one in every five global deaths (afshin et al., ) . diet related risks also monopolize large portions of many national health-care budgets (phe, ) . from - , it is estimated that an average of ⋅ % of healthcare expenditure in the organisation for economic co-operation and development (oecd) member countries will be spent treating obesity-related diseases, equivalent to us dollars (usd) purchasing power parity billion per year (oecd, ) . current food systems exploit demand for affordable, convenient, and tasty food to encourage consumption of nutritionally poor, ultraprocessed foods in both high, middle and low income countries. as economic markets incentivize expanded food value chains, they inevitably produce food with more and more processing to improve taste, texture, and longevity (swinburn et al., ) . the processed state of these foods, not necessarily the macronutrient content or energy density, induces increased calorie intake and weight gain associated with exposure to ultra-processed foods (hall et al., ) . marginalized groups in high income countries are often reliant on these highly processed, energy-dense, nutrient poor foods to meet their energy needs. ultra-processed foods can be aspirational in low and middle income countries (lmics) and are becoming more affordable and convenient (swinburn et al., ) . these foods (and the value chains that produce and market them) are among the most impactful determinants of the growing global burden of food-related ncds. food-related ncds also increase susceptibility to infectious disease. for diseases such as zika, west nile, and dengue death is rare in the absence of any pre-existing conditions (badawi et al., ; chan-yeung and xu, ) and preliminary analysis suggests that the likelihood of adverse outcomes in sars-cov- are significantly higher in patients with hypertension and diabetes (zhou et al., ) . this increased risk may be driven by upregulation of the sars-cov- receptor ace or heightened inflammation in people with these comorbidities (pinto et al., ) . these diet-related co-morbidities are visible symptoms of underlying structural inequalities which result in marginalized communities bearing disproportionate disease burdens (garg et al., ; icnarc, ) . whilst the quantity and nutritional quality of our global diets gains increasing attention, foodborne diseases are also associated with a substantial human health burden, with approximately million dalys lost annually through of the major foodborne diseases, the burden of which are disproportionately borne by lmics (jaffee et al., ; li et al., ) . thirty-five percent of this burden is attributable to pathogens from animal source foods (asfs) (li et al., ) , the increasing demand for which, particularly across lmics, is a major driver in an increasing foodborne disease burden (quested et al., ) . specific aspects of livestock value chains associated with an increase foodborne disease risk may differ across 'informal' and 'formal value chains. high prevalence foci of the zoonotic tapeworm taenia solium, etiological agent of neurocysticercosis, are found where free-ranging pig husbandry practises coincide with low levels of sanitation and insufficient implementation of meat inspection . informal value chains, which supply - % of food needs in sub-saharan africa, and the poorly regulated slaughter, processing and retail practises associated with them can result in extensive microbial contamination of products, which may not be sufficiently mitigated by consumer food preparation practises (jaffee et al., ) . the formalisation of livestock value chains does not completely mitigate all foodborne disease risks. longer value chains with increasing number of processing or handling steps between 'farm and fork' provide opportunities for cross-contamination, adulteration or spoilage without sufficiently enforced regulation. the progressively intensified systems of livestock production seen increasingly across the globe may also exacerbate the risk posed by microbial hazards. intensive systems bring animals into close proximity under circumstances which induce metabolic and psychological stress (humphrey, ; martínez-miró et al., ) , increasing the contact opportunities and susceptibility of these populations for disease transmission, including those pathogens which have important implications for food safety. this is particularly evident in monogastric systems, where intensive production contributes to over half of the global pork production and over % of global poultry production (steinfeld et al., ; thornton, ) , and where campylobacter and salmonella spp. have been increasingly prevalent (carrique-mas et al., ) . in order to mitigate the effects of high pathogen challenge, which also have production-limiting effects, intensive livestock systems have been heavily reliant on antimicrobials for prophylactic, treatment and growth promotion reasons . resistant bacteria reside in humans, animals, food and the environment and there are no barriers to the transmission of resistance genes between these sites or amongst bacterial species (holmes et al., ) . pathways for the spread of resistant organisms, from within animal populations to humans, are well recognized and result from the selective pressures from antimicrobial use in livestock. consequently, antimicrobial use in food-producing animal species represents an important driver of antimicrobial resistance (amr) (marshall and levy, ) . the human health burden from amr is forecasted to reach trillion usd by with a worldwide mortality around million (o'neill, ) . in response to the amr crises, there is growing international pressure to reduce the use of antimicrobials within livestock systems and to prohibit the use of antimicrobial growth promoters (agps) in livestock. trade-offs exist, however, between the risks of antimicrobial use and the pressure to ensure global food security. a ban on agps could be associated with a reduction in the value of global meat production of between and billion usd and restricting the use of antimicrobials for prophylactic and therapeutic use whilst retaining current intensive husbandry practices will impact both productivity and animal welfare. lastly, disease emergence and transmission are of growing concern within our intensive, increasingly homogenous and interconnected food systems. lack of genetic diversity has become commonplace in our global food systems, within both livestock and crop production (bennett et al., ; khoury et al., ) , and is a risk factor for heightened susceptibility to outbreaks of plant and animal disease. this 'monoculture effect' is best illustrated in agronomy, where non-diverse cropping can lead to large scale losses, such as those suffered through rice blast (zhu et al., ) and the panama disease epidemic of bananas in the s (ordonez et al., ) . similar genetic susceptibilities exist within livestock. porcine reproductive and respiratory syndrome virus, a major disease burden to the global pork sector, has led to exacerbated losses within genetically homogenous herds as compared to herds with a wider genetic pool (lunney et al., ; halbur et al., ) . as well as the emergence of production limiting pathogens within livestock systems, the emergence of novel, zoonotic pathogens from our food systems is at the forefront of the global consciousness, of which sars-cov- is only the latest example in an increasing frequency of such events. novel zoonoses have emerged most commonly from wild mammals such as rodents and bats, which have either adapted to anthropogenic habitat changes, or have increased contact with humans or livestock through agricultural incursions into habitats or establishment of bush-meat value chains (johnson et al., ) . examples of direct pathogen spillover from wildlife directly to humans, predominantly associated with formal or informal bushmeat value chains, include hiv and ebola (hahn et al., ; kock et al., ) . there is also a potential threat to human health from the transmission of disease from wildlife into livestock populations and then further propagation through intensive production (wilcox et al., ) . in cases of the novel febrile encephalitis, nipah virus (niv), emerged amongst pig farmers in malaysia. the intensification of mango and pig production within a localised geographical area are believed to have provided a pathway for the virus, circulating in fruit bats, to infect an intensively managed commercial pig population and subsequently spread to farmers (pulliam et al., ) . zoonotic and non-zoonotic disease outbreaks and our responses to the presence or risk of these pathogens can destabilize food systems, leading to increased food insecurity and downstream health and economic effects. fig. illustrates several of the key disease outbreaks of the previous three decades which have had profound impacts on human health and food-security. in europe, outbreaks of bovine spongiform encephalitis (bse) and food and mouth disease (fmd) led to large scale supply and demand shocks in the beef and dairy industries. the use of meat and bone meal in cattle feed was associated with the mid 's emergence of the degenerative prion disease bse, which was later found to cause newvariant crutzfeldt-jacob disease (nvcjd) in humans (anderson et al., ) . this led to a raft of mitigation measures with short and long-term costs, including large scale culling programmes, new harvesting and processing regulation, a ban on animal by-product use in animal feeds and restrictions on beef and other animal products (including milk, semen and embryos) export from affected countries (kimball and taneda, ; thiermann, ) . the effects on the food system and health from the fmd outbreak in the uk also extended beyond production losses (knight-jones and rushton, ) . trade restrictions between fmd free and fmd affected countries were sometimes extended to unrelated products. culls produced public outrage against the livestock industry that outlasted the outbreak itself, which together likely contributed to the observed spike of depression and suicide among farmers (thomas et al., ) . in areas where a large proportion of the population is dependent on agriculture for both income and food supply, such as ethiopia, endemic fmd has direct effects on the food security of farmers by reducing milk production and oxen availability for cropping (knight-jones and rushton, ) . pork is now the most frequently consumed meat per capita worldwide and is responsible for over half of meat consumption in asia (ritchie and roser, ) . introduction of african swine fever virus (asfv) into china, home of approximately % of the global herd (ritchie and roser, ) , resulted in rapid spread throughout the naive pig population. over % of pigs have died or been culled (fao, ), causing an estimated $ billion in direct economic losses (moore, ) and reverberations through industries including feed mills, veterinary services, restaurants, and tourism. pork prices soared to a peak of % year-on-year (moore, ), increasing demand for and price of other meat products and leaving poorer households at increased risk of food insecurity and malnutrition (rocha et al., ) . similar patterns were seen across the same region less than a decade before in response to outbreaks of highly pathogenic avian influenza where aggressive containment measures drove increases in meat prices and heightened local food insecurity (burgos et al., ) . lmics, particularly those in southeast asia, are the site of the majority of industrialized poultry farming. large scale flocks are more likely to contract hpai (h n ) than small, personal flocks (otte et al., ) and experience the greater share of economic effects. yet smallholders, traders, slaughterers, and transporters are at greatest risk of personal negative health outcomes as a result of such diseases, as they often belong to poor households that are unable to weather economic shocks and are sensitive to food insecurity and malnutrition. the west african ebola outbreak of provides an example of severe, localized effects of an outbreak on the food system due to travel restrictions and market closures (mann et al., ) . panic buying caused shortages of some items and dramatic increases in prices. labor shortages resulted in decreased food production and loss of income across communities, particularly in rural regions (de la fuente et al., ) . nutrition operations were a low priority among humanitarian response groups and were inadequately supplied (kodish et al., ) . they also neglected to consider the needs of communities that did not have ebola outbreaks but had become food insecure from food production losses. after the outbreak, many ebola disease survivors were denied the opportunity to purchase food due to lingering fear of infection. on a global scale, the ongoing covid- outbreak has also led to massive perturbations in food systems. lockdowns and retail closures directly cause food insecurity among vulnerable populations, national stockpiling has prompted some countries to halt or reduce exports of staple grains and legumes (reuters, ) , and travel restrictions have inhibited farmers across europe from hiring seasonal migrant workers to harvest fruit and vegetable crops (carroll et al., ) . workers in food retail and transport that remain employed are experiencing unexpected health risks, severely reducing the ability of some sectors of our food-systems to operate as has been particularly noticeable in the vulnerability of meatpackers and subsequent covid- -related shutdown of some meat processing plants in usa (apostolidis, ) . workers provided with little protection or compensation have in some instances organized strikes to protest their lack of economic and health protection (mcginnis, ) and lengthy screening proceedures or social-distancing measures have the potential to dramatically reduce production capacity in some sectors (hailu, ) . once social distancing protocols are lifted, medium to large enterprises will likely be best poised to recover and many small businesses integral to local food systems will be unable to bounce back, producing economic knock-on effects on wholesalers, processors, and producers across the supply chain. while food insecurity surges as a result of control measures, food waste is also increasing. it is estimated that over a third of all food produced for human consumption is wasted (fao, ), a figure which will grow as shopping patterns change from multiple small shops per week to larger, more infrequent shops (cranfield university, ). food systems lack the flexibility needed to adjust to rapidly evolving situations within disease outbreaks, causing still more waste (evans, ) . restaurant and coffee shop closures have decreased demand for milk and dairy farmers have been told to pour milk down the drain, yet supermarkets have restricted purchase of milk and other core products (keane, ) . closures of large meat processing plants due to worker illness will result in large scale culling of animals across the usa. meanwhile, emergency assistance agencies are running low on supplies to support the deluge of the newly food insecure (power et al., ) . despite the undeniable link between our food systems and health, the sustainable development goals (sdgs) do not explicitly link these areas other than within the context of malnutrition (un, ) . public health policies must pay greater consideration to the role of food systems as the baseline of population health, while agri-food policies should consider human health as their raison d'être. agri-food policies can promote health in direct and indirect waysglobally % percent of employment is in agriculture, this rises to % in low income countries (world bank, ). sustainable agriculture supports economic prosperity, environmental wellbeing, and social equity (i.e. the triple bottom line), all of which further support stable access to healthy diets and healthy environments. well executed, integrated health-agri-food policy should improve baseline health, mitigate infectious disease risks and increase the resilience of our food systems to protect food security, particularly for the most vulnerable. herein we highlight some key examples of these policies in action, where further strengthening is required, and the dynamics that complicate enactment of health-centered agri-food policy (fig. ) . evidence-based health-agri-food policies that support access and uptake of healthy diet and exercise, particularly in communities with high inequality, can help reverse the growing trend towards obesity and minimize morbidity and mortality from infectious disease. a multipronged approach is needed to set healthy food preferences at an early age, change the environment to encourage healthy choices (particularly fig. . integration of health and agri-food policy. current and recommended agri-food and health policies to reduce the frequency and impact of disease outbreaks. at the point of purchase), and reduce barriers to expression of healthy preferences (hawkes et al., ) . policies that limit consumer exposure to less healthy foods by reducing portion sizes, reformulating foods, and regulating advertising are often blocked or weakened by lobbying groups (swinburn et al., ) . there is little immediate financial motivation to adopt more environmentally and health friendly standards, though social demand is increasingly reorienting markets to value transparency and social and environmental aspects of corporate performance. policy interventions that rely on behavioral change, such as consumer awareness campaigns and front of pack labeling, are relatively easier to enact but have limited longevity or effectiveness in the presence of other food stimuli or under stress (hill, ; leng et al., ) . the dynamics surrounding the adoption, implementation, and effectiveness of regulatory health policy are exemplified by the high fat, salt, and sugar (hfss) taxes that have been adopted across diverse nations with a wide range of outcomes (world health organization regional office for europe, ). most slightly reduced consumption of hfss foods but it is unclear what affect, if any, these taxes have on other health indicators in isolation. low income consumers that rely on affordable, energy-dense foods may be unduly burdened by hfss taxes but benefit from alternative price interventions such as subsidization of fruit and vegetables (neff et al., ) . while current regulatory interventions in isolation have minimal effect on downstream health indicators, they provide precedent for future regulatory policy and encourage action surrounding the role of large companies in shaping the food environment. significant improvements in global population health will require cooperation of people and companies involved in food systems to fundamentally change how they operate, but some communities have overhauled their local food environments with a ground-up, systemic approach that bypasses many of the barriers encountered on a national level and inspires awareness and innovation. in baltimore, usa, policies have been enacted to re-familiarize consumers with the systems and people that produce their food (department of planning, ), incentivize wholesaler produce distribution to small convenience stores, and encourage grocery chains to move into low income communities. city government also supports local ownership of food retail outlets in underserved neighborhoods, cultivating economic growth, a sense of community, and the agency to improve the health issues people see in their neighborhood. baltimore's food policy initiatives demonstrate how to mobilize community members to incorporate agri-food policies across city operations and government, business and economic development, and community organizations to combat the multifactorial roots of poor dietary health. even prior to the covid- pandemic the international community had been aware of the increasing threat from emerging zoonotic pathogens, the 'dual burden' imposed by endemic zoonoses on livestock productivity and human health, the biological and chemical hazards present in our food and the looming spectre of a post-antibiotic world. the protection of consumers from zoonoses and foodborne diseases acquired from the consumption of diseased animals or via unhygenic slaughter and processing has been a concern for centuries and formal meat inspection, still broadly recognisable today, was instigated in europe in the 's (edwards et al., ) . the multi-faceted nature of infectious disease risks within our food-systems and the plethora of public and private actors working within them, with differing roles and responsibilities has driven calls for an integrated 'one health' approach, endorsed at the highest level by the who, oie, fao tripartite and the world bank. despite growing acceptance of this concept internationally and the establishment of several regional and national one health units, there are still major challenges in operationalization. power struggles between ministries for 'ownership' of the movement, poorly integrated policies, lack of interoperability in data systems, and resource constraint for frontline services have all been identified as key barriers, and the multiplication of one health initiatives, specifically those with single issue focus, may risk undermining the strength of the moment (spencer et al., ) . this splintering and 'siloisation' of one health can be illustrated by kenya, where four separate one health bodies now exist with separate remits for zoonoses, amr, aflatoxins and pesticides but with no over-arching co-coordinating mechanism across these areas, and with other one health issues such as foodborne disease lacking an inter-ministerial 'home' (kimani et al., ) . although challenges exist, the one health approach has been repeatedly employed to mitigate animal and human disease threats, as exemplified by the response to colistin resistant e. coli (crec) in china (wang et al., ) . colistin is used predominantly in the livestock sector but is an important antimicrobial of last resort for human disease. following the discovery of widespread distribution of colistin resistance gene mcr- in e. coli, the chinese ministry of agriculture and rural affairs banned use of colistin as a growth promoter in livestock. three years on, significant reduction was observed in the relative abundance of mcr- in pigs, crec carriage in pigs and chickens, human carriage of mcr- positive e. coli, and human infection with crec. a clearly defined problem and solution, strong political support, and effective inter-agency enforcement contributed to the success of this policy and provides guidance for future approaches to threats to animal and human health. the one health approach will only be as strong as its constituent parts; environmental stewardship is often missed completely, whilst veterinary and human public health systems have often been chronically under-funded in favor of support to primary food production and curative human medicine. strengthening these capacities and meeting countries' commitments under the international health regulations and the oie pathway for veterinary services programmes is integral to the global health security agenda (belay et al., ) . the capacity building activities within the ghsa thus far have relied predominately on external donor funding. ultimately, the sustainability of these activities will require resource commitments by national government and a greater acknowledgement of the role of private actors across food systems (kelly et al., ) . there an increasing number of private standard setting organizations to enhance global food safety such as the global-good agricultural practises standard (king et al., ) . private standards can be excessively high, which improves food safety but may be unattainable for smallholders or farmers in lmics, effectively shutting them out of global markets and further highlighting the need for a collaborative, multi-sectoral approach to food safety. responses to emerging pathogens and outbreaks are often fear driven and reactionary. during the swine flu (h n ) outbreak, egypt culled their entire pig population, despite pigs not transmitting the virus to humans (atlani-duault and kendall, ). traceability systems have become more sophisticated and widespread and can support narrower outbreak responses, yet retailers and governments often issue blanket recalls and import restrictions during health crises (van der vorst, ) . similar to other components of food safety programs, development of and compliance with better traceability systems largely rest with private companies and may not be harmonized with standards set by public health bodies. to improve response time and accuracy during outbreak events, quality traceability systems across the value chain must be combined with transparency and communication with decision makers. prior to such events, governments should develop and train networks of communication that connect food systems agents, trustworthy spokespeople, and consumers to minimize panic and reactionary measures (who et al., ) . national outbreak preparedness plans and risk reduction strategies concerning diseases that originate outside the food system typically do not include considerations for protecting food systems but should be a key factor in planning potential response efforts (ortu et al., ) . localities can contribute to outbreak preparedness by conducting food system vulnerability assessments using fault tree analysis across a range of emergencies (biehl et al., ) . even when food systems are considered in planning exercises, insufficient follow through, lack of resources, or unwillingness to allocate available resources may render such exercises meaningless. policymakers must prioritize action following planning exercises, as emerging infectious disease and food safety events are increasingly likely as food systems become more globalized. corporate concentration of agricultural sectors both horizontally and vertically has resulted in centralizing control of large swaths of the food system among a few companies, reducing the resilience of food system to internal and external shocks (howard, ) . these oligopolies have vast lobbying power, making it difficult to enact structural change. positive change at this level will require market incentives and non-governmental accountability systems similar to what is seen in current efforts to combat climate change (heymann et al., ) . reliance on food imports also increases vulnerability to food insecurity. an estimated / th of the global population in were dependent on food imports for their basic dietary needs (fader et al., ) , leading to an unequal power dynamic between net-exporters & net-importers and undermining the development of locally appropriate value-chains. at the production level, agri-food policies which support local farmers and smallholders can strengthen food system resiliency by increasing the diversity of local food systems and protecting against economic shock. one example is the uk government department for the environment food and rural affairs' farm diversification grant scheme, which helped farmers in the uk develop a diverse portfolio of income sources (turner et al., ) for this reason. support for agricultural diversification among smallholders in lmics can improve food security, reduce poverty, and strengthen resilience to climate change and market instability, resulting in long term increases in productivity (joshi et al., ; world bank, ) . however, there are several obstacles to farm-level adoption of diversified farming systems, including start-up costs, potential initial productivity losses, lack of access to technical guidance or support, and market disencentives such as commodity crop subsidies and insurance (harvey et al., ) . some farm level barriers can be overcome with an institutionally organized systems or landscape approach that incorporates multiple stakeholders to achieve a collective diversification goal. policymakers should work to increase accessibility of diversification tactics, support research to provide further evidence and guidance for diversification, and ensure follow through on these commitments. while the countries in the african union have pledged to enhance financial investment in agriculture, only nine are on track to reach agricultural research spending goals (vilakazi and hendriks, ) . at the consumer level, stable access to food during periods of crisis can be ensured by policies that support emergency food access and flexibility within supply chains. the covid- outbreak underscores the need for policies to support and improve access to food assistance agencies, which not only supply emergency food but also help those in need access benefits, job training, and medical resources (environmental audit committee house of commons, ). food systems have wide and far-reaching impact on health, economy, and society locally and globally, while health issues and our response to them have major impacts on how food systems operate. a sustainable and healthy food system supports fair wages for individuals across the food value chain, provides affordable, nutritious, diets that are culturally acceptable, operates in an environmentally sustainable manner, and is resilient and adaptable. foodborne disease and emerging infectious disease events should naturally decrease as food systems approach these ideals. this vision is far-removed from the current reality but provides a set of priorities through which agri-food policies should be developed. major challenges exist concerning the reorientation of market incentives and food systems standards, heightened accountability, 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urbanization, land-use diversity, and livestock intensification in zoonotic emerging infectious diseases productive diversification of african agriculture and its effects on resilience and nutrition, productive diversification of african agriculture and its effects on resilience and nutrition world health organization regional office for europe emergence of african swine fever in china genetic diversity and disease control in rice the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. key: cord- -m hkj dm authors: schwartz, rachel; sinskey, jina l.; anand, uma; margolis, rebecca d. title: addressing postpandemic clinician mental health: a narrative review and conceptual framework date: - - journal: ann intern med doi: . /m - sha: doc_id: cord_uid: m hkj dm previous pandemics have seen high psychiatric morbidity among health care workers. protecting clinician mental health in the aftermath of coronavirus disease (covid- ) requires an evidence-based approach to developing and deploying comprehensive clinician mental health support. in a narrative review of articles addressing clinician mental health in covid- and prior pandemics, themes emerged: ) the need for resilience and stress reduction training; ) providing for clinicians' basic needs (food, drink, adequate rest, quarantine-appropriate housing, transportation, child care, personal protective equipment); ) the importance of specialized training for pandemic-induced changes in job roles; ) recognition and clear communication from leadership; ) acknowledgment of and strategies for addressing moral injury; ) the need for peer and social support interventions; and ) normalization and provision of mental health support programs. in addition to the literature review, in collaboration with the collaborative for healing and renewal in medicine (charm) network, the authors gathered practice guidelines and resources from health care organizations and professional societies worldwide to synthesize a list of resources deemed high-yield by well-being leaders. studies of previous pandemics demonstrate heightened distress in health care workers years after the event. the covid- pandemic presents unique challenges that surpass those of previous pandemics, suggesting a significant mental health toll on clinicians. long-term, proactive individual, organizational, and societal infrastructures for clinician mental health support are needed to mitigate the psychological costs of providing care during the covid- pandemic. t he coronavirus disease (covid- ) pandemic has exacerbated preexisting burnout and moral injury in health care professionals. clinicians are dying not only of physical manifestations of covid- , but also of the emotional and mental health repercussions of caring for persons who are suffering without loved ones by their side ( ) ( ) ( ) . concerns about adequate personal protective equipment (ppe), reliable testing, absence of specific treatments, risk for infection to self and family, lack of access to up-to-date information among ever-changing guidelines, and uncertainty about containment of disease also threaten clinician well-being ( , ) . many health organizations have already committed resources to clinician well-being, including chief wellness officer positions and well-being programs ( ) . these institutions must adapt their existing well-being infrastructure to meet evolving needs. other organizations have yet to establish such programs and will benefit from a blueprint for a coordinated, systemic approach. evidence from previous epidemics and disasters underscore clinicians' high risk for long-term mental health issues and emphasize the need for continued support during and after the pandemic ( ) ( ) ( ) ( ) . the covid- pandemic has necessitated rapid development and deployment of innovative solutions in medicine, including well-being resources for clinicians. as we look to an uncertain future, a conceptual framework for how to develop and deploy these resources will facilitate well-being endeavors and provide a foundation for addressing long-term needs. we performed a literature review and compiled a comprehensive guide to clinician mental health and well-being resources compiled by well-being leaders. we provide a conceptual map for allocation of these resources at the individual, organizational, and societal levels, focusing on addressing clinician well-being needs in the postpandemic phase. this narrative review targeted the existing literature on clinician mental health and wellness needs in response to both covid- and previous pandemics. psycinfo, pubmed, scopus, and web of science were searched by using the keywords "covid* or corona*" "mental health", "trauma", "resilienc*", "coping", "anxiety", "burnout", "wellness or wellbeing", "occupational stress" "frontline or medical or hospital or health care workers or medical students or physician or nurse" "pandemic or outbreak or surge". articles were included if they provided evidence on ) prevalence of mental health symptoms during or after the pandemic and ) individual, organizational-level, or societal-level responses to or assessment of mental health in health care workers. the dates of the literature search were july (to capture the first severe acute respiratory syndrome [sars] outbreak) through may . ongoing updates to the initial search were conducted through the end of may to capture additional in-press articles. each author was responsible for searching database, and included articles were reviewed by all authors to determine their relevance. this peer-review process yielded articles included in the narrative review. in addition to the comprehensive literature search described, we peer-reviewed well-being resources gathered by the collaborative for healing and renewal in medicine (charm) network. the charm network is a group of medical educators, leaders in academic medicine, experts in burnout research and interventions, and trainees working together to promote well-being among trainees and practicing physicians ( ) . this action-oriented group, through regular teleconferences and electronic communication, focused on creating deliverables for widespread dissemination during the covid- pandemic to support the well-being of health care workers and their organizations. we reviewed practice guidelines and resources from numerous health care organizations and professional societies worldwide across various specialties (table) . through the charm network, we gathered and then reviewed and annotated various media, including web site resources, podcasts, popular media articles, web-based applications, and any resource deemed high-yield by well-being leaders. clinician well-being efforts fall into interrelated categories: individual (for example, emotional awareness and self-care), organizational (for example, mental health support programs, engaged leadership), and societal (for example, supportive culture in medicine, national policies that enhance well-being) ( ) (figure) . this review yielded insight in areas: the prevalence of clinician mental health needs during and after a pandemic, and postpandemic strategies for comprehensive clinician mental health support. the mental health toll of past pandemics on health care workers has been well documented. chong and colleagues ( ) estimated % psychiatric morbidity among health care workers in a tertiary hospital in china during the recovery phase of the sars epidemic. goulia and colleagues ( ) found that . % of health care worker participants reported moderately high anxiety during the a/h n pandemic in greece, noting that degree of worry was an independent correlate of anxiety. maunder and colleagues ( ) reported significantly higher levels of distress, burnout, and posttraumatic stress in health care workers who treated patients the covid- pandemic presents unprecedented psychological threats to clinician well-being; evidence from previous epidemics and disasters underscore clinicians' high risk for long-term mental health issues and emphasize the need for comprehensive mental health support during the covid- recovery phase. addressing clinician wellness requires proactive support, because this population is known for not seeking support and for putting others' needs before their own. developing institutional and societal infrastructure that ensures clinicians' basic needs are met and arms them with psychological and social support tools is necessary to mitigate the known psychological costs of providing care during a pandemic. with sars compared with their colleagues who did not have direct contact with patients with sars. health fear, social isolation, and job stress were mediating factors. two months into the sars pandemic, chan and huak ( ) found that about % of health care workers in a hospital in singapore reported symptoms indicative of posttraumatic stress. after the sars outbreak in taiwan, bai and colleagues ( ) reported a range of stressrelated responses, such as acute stress disorder, feelings of stigmatization and rejection, and reluctance to go to work. there has been growing evidence of distress and mental health issues among health care workers treating patients with covid- . dzau and colleagues ( ) noted moral distress, anxiety, and suicide as negative effects of the covid- pandemic and caution about possible increases in burnout. depression, anxiety, insomnia, and distress have been reported among health care workers in china during this pandemic ( ) . a systematic review of covid- -related studies reported stress, anxiety, depression, and insomnia among health care workers ( ) . excessive work hours, inadequate ppe, infection rate among medical staff, feeling a lack of support, and extensive media coverage were noted as factors associated with adverse psychological outcomes. in trying to understand anxiety associated with covid- , maben and bridges ( ) outlined possible mental health-related issues in nurses in the united kingdom, such as moral distress and fatigue, discomfort, and difficulties in communication due to wearing masks and full ppe. stigma among the larger community and being perceived as a threat to safety of others were other issues that they outlined. kisely and colleagues ( ) conducted a systematic analysis of studies documenting the mental health effects of pandemics, such as covid- , sars, middle east respiratory syndrome, h n , h n , and ebola. they reported that staff in direct contact with patients had higher levels of posttraumatic stress and psychological distress. women, younger clinicians, and parents with dependent children were demographic fac-tors associated with greater psychological distress. shanafelt and colleagues ( ) found that themes emerged in discussions with health care workers: inadequate ppe, exposure to self and carrying of infection to family members, lack of rapid testing availability in the face of symptom development, exposing others at work, access to child care resources, support for other personal and family needs, uncertainty about organizational support, lack of up-to-date information and communication, and feelings of inadequacy if deployed to new areas. a qualitative study with general surgery residents in boston centers found that the health of their family, risk for being infected by patients, risk for carrying infection to family members, anticipatory overwork due to patients with covid- , and risk for infecting patients were common concerns ( ) . in a survey of surgical residents, more than one half of respondents reported psychological strain as a result of the pandemic ( ) . environments that combine high levels of anxiety with prolonged uncertainty and reduced agency place clinicians at high risk for developing persistent stress exposure syndromes and burnout ( ) . the covid- pandemic presents unprecedented challenges due to prolonged uncertainty and heightened anxiety, immediate threat to personal and family safety, social isolation, witnessing physical suffering and death, and evolving professional demands. these individual stressors combine to induce hyperarousal, hypervigilance, sleep disturbance, intrusive thoughts, depression, and grief ( ). schreiber and colleagues ( ) reported that when first responders experienced or more cumulative stress factors or specific factors (performing duties outside their perceived skill set; witnessing a coworker become sick or injured, or die; and feeling that their own life is in danger), they were at higher risk for developing posttraumatic stress disorder months later. seven themes, and associated interventions, emerged from the literature (figure) : ) the need for resilience and stress reduction training; ) providing for clinicians' basic needs (food, drink, adequate rest, quarantine-appropriate housing, transportation, child care, ppe); ) the importance of specialized training for pandemic-induced changes in job roles; ) recognition and clear communication from leadership; ) acknowledgment of and strategies for addressing moral injury; ) the need for peer and social support interventions and; ) normalization and provision of mental health support programs. across studies, there was an emphasis on implementing training programs that target clinician selfcare, normalize anticipated psychological response to crisis, and promote adaptive response and self-efficacy ( , - ) . schreiber and colleagues' ( ) anticipate, plan, and deter (apd) model incorporates pre-event training ("anticipate"), explaining the nature of cumulative responder stressors and anticipated stress reactions; development of a personal resilience plan ("plan") to identify and document anticipated challenges and positive coping strategies; and trains participants on self-monitoring stress exposure to know when to implement personal resilience plans ("deter"). albott and colleagues ( ) developed a psychological resilience intervention that focused on self-care, selfefficacy, and social connection while providing rapid ongoing access to mental health support. blake and colleagues ( ) developed and disseminated a digital e-package with evidence-based guidance for psychological well-being. the content focused on self-care strategies at work and home, managing emotions, and encouraging help-seeking behavior. fessell and cherniss ( ) identified actionable "micropractices" for physicians to implement during the workday, such as wellness selfchecks and naming emotions. practice implications. given the demonstrated value of stress reduction and resiliency training, integrating these practices as a key part of clinician training may reduce distress. strategies for addressing clinicians' basic needs during the covid- pandemic ranged from covering basic meals and transportation needs to establishing a "well-being area" within the hospital in which staff and volunteers could rest ( ) and providing living quarters, complete with food and living supplies, so that clinicians to safely quarantine from family ( , - ). one chinese hospital helped clinicians create videos of their work routines to share with family to assuage concerns ( ) . institutions in urban settings, where most rely on public transit, chose to subsidize clinicians' transportation, exploring bicycle and car rental options ( ) . child care coverage and ppe are other essential needs ( , , ). some cities provided centers for children of health care workers, whereas other institutions developed volunteer programs connecting nonessential employees with frontline clinicians ( ) . practice implications. ensuring that clinicians' basic needs (food, adequate rest, shelter, transportation, child care, and ppe) are met is essential for their psychological well-being. although not mentioned in the reviewed articles, the unfolding financial impact of the covid- pandemic is another stressor whose effect has yet to be measured. delivering care during a pandemic requires operating in a high-anxiety environment and, in many cases, being prepared to assume new professional roles to meet evolving needs. training clinicians on infection control was shown to alleviate stress ( ), because it arms them with protective tools. formalized training on how to identify and respond to patients' psychological distress was requested as another strategy for clinician support ( ) . finally, redeployment to a new clinical role in the case of a patient surge was a core source of anxiety that could be addressed through assessment of clinician skill sets before redeployment, targeted training, and improved information about redeployment plans ( , ) . practice implications. hospitals should consider adopting specialized skills assessment and training programs and use clear communication practices around redeployment to prepare for future needs. many articles spoke to the importance of clinicians receiving recognition from leadership and the effect this had on well-being. receiving recognition from hospital and government leaders was a motivational factor that supported covid- clinicians' ability to continue delivering care ( ) . transparent, bidirectional communication empowers clinical teams and improves morale ( , ) . delivering current, reliable, and reassuring messaging improves transmission of critical information to clinical teams ( ) . effective strategies include synthesizing information into a daily digest that links to a comprehensive resource page and providing weekly virtual town halls to disseminate critical information ( ) . practice implications. leadership can leverage communication strategies to provide clinicians with up-to-date information and reassurance. the ethical, social, and professional obligations toward their profession are frequently reported as the core motivator for clinicians' decision to provide care while putting themselves at risk ( , ) . this commitment to serving others, even at the cost of their own well-being, makes clinicians a uniquely vulnerable pop-review addressing postpandemic clinician mental health ulation. moral injury is defined as psychological distress caused by a betrayal of what is right by someone in authority in a high-stakes situation ( ) , or witnessing, perpetrating, or failing to prevent acts that transgress core moral beliefs ( ) . the covid- pandemic presents multiple potential sources of moral injury for clinicians, such as determining which patients will not receive life support owing to inadequate resources or bearing witness to (and having to enforce) policies that lead to patients dying alone ( ) . williamson and colleagues ( ) identified a set of strategies for addressing moral injury in frontline covid- clinicians. they recommend making clinicians aware of the possibility of moral injury and associated symptoms. encourage clinicians to seek informal support from colleagues, managers, or chaplains and provide rapid access to professional help; however, it is known that those suffering from moral injury often fail to discuss it owing to shame and guilt. as a result, leadership must proactively and routinely monitor the psychological well-being of their teams. practice implications. clinicians are unlikely to disclose moral injury. psychological well-being should proactively be assessed, and both informal and professional support should be readily available to clinicians. depriving humans of social connection comes at a high psychological cost ( ) , and the covid- pandemic interferes with the ability to connect with colleagues and even one's own family owing to mandatory infection control precautions. social support is associated with decreased stress and anxiety and increased self-efficacy and sleep quality ( ) . to sustain clinician well-being, heightened attention must be paid to fulfilling their social support needs. whereas peer support occurs on an individual level, institutional programs provide a structured approach to building peer support and connection. one innovative strategy by albott and colleagues ( ) involved implementing a "battle buddy" model borrowed from the military that paired individuals on the basis of clinical area of practice, career stage, and life circumstance. each partner in the team engages in daily conversation and looks out for the other's well-being. if distress is observed, mental health support is proactively deployed. walton and colleagues ( ) provide a comprehensive description of the physical, behavioral, emotional, and cognitive indicators of acute stress reactions; training clinicians to be aware of these reactions, in themselves and others, may allow for better peer support and intervention. other proposed solutions include routinely holding schwartz rounds, an interprofessional forum for health care professionals to discuss the emotional, social, and ethical challenges of work, during changing shift periods ( ) . practice implications. providing routine opportunities for social connection can improve clinician well-being. the provision of clinician mental health support is not currently standard practice in the united states. self-report questionnaires and observations of frontline clinicians during the covid- pandemic demonstrated that they are unlikely to seek out psychological support resources ( , , ) , despite the availability of these resources. leadership can normalize mental health support by modeling self-care and help-seeking behaviors ( ) , ensuring that available mental health resources are well-publicized, and developing a culture of caring with frequent check-ins with colleagues to assess psychological well-being and a protocol for professional referrals as needed. establishing opportunities for clinicians to anonymously share concerns allows them to safely advocate for themselves and their patients ( ) . on a societal level, it is necessary to establish new infrastructure that will sustain and supplement existing clinician support programs. dzau and colleagues ( ) recommend allocation of federal funding to care for clinicians who have been impacted by their covid- service and establishing a national epidemiologic tracking program to track clinician well-being and the effect of wellness interventions. developing multidisciplinary mental health teams at the regional and national levels can allow clinicians greater access to needed resources ( , ) . practice implications. routine provision of mental health education and support needs to be delivered proactively to protect long-term clinician well-being. federal funding for clinician well-being is needed to track clinician wellness and establish the resources necessary to care for those negatively affected by their covid- service. crisis and virtual mental health services must be easily accessible for health care workers. the table provides details on the resources discussed in this section. the physician support line ( ) is a national, free, and confidential support line service made up of volunteer psychiatrists, joined together to provide peer support for their physician colleagues. for those in crisis, additional resources include the national suicide prevention hotline ( ) and crisis text line ( ) which operate / . mindfulness resources for emotional regulation have been shown to decrease physician burnout ( ) . headspace ( ) , a popular mindfulness web-based application, is offering free membership to u.s.-based health care professionals to help cope with stress and anxiety with resources for sleep, meditation, and movement exercises. the accreditation council for graduate medical education (acgme) aware well-being resources ( ) include video workshops, podcasts, and a web-based application designed to promote wellbeing in the graduate medical education community. the well-being in the time of covid- podcast by stuart slavin, md, (acgme's senior scholar for wellbeing) provides well-being strategies for residents, fellows, and other clinicians from resources that include psychology and psychiatry, peer support programming, the military and veterans affairs, and literature for support of first responders to mass casualty events. the national academy of medicine ( ) web site is a clearinghouse of resources to support the health and well-being of clinicians that includes links to numerous global health, governmental, and medical society recommendations. the centers for disease control and prevention ( ) collated a comprehensive list of factors to consider during covid- related to coping and stress, including considerations for first responders, and also serves as a resource for communities, families, and people at higher risk for serious illness. the center for the study of traumatic stress ( ) is a high-yield, well-edited resource library with material targeted for health care workers, leaders, and families, including fact sheets, journal articles, textbook chapters, webinars, and infographics within the public domain. the united kingdom's intensive care society ( ) offers a well-being resource library includes visual resources that can be displayed to educate staff on self-care, sustaining staff well-being during covid- , and specific critical care workplace interventions to improve local environments. across studies, frontline workers are at highest risk for developing acute stress, depression, anxiety, and insomnia ( , , ) . approximately % of italian covid- frontline clinicians experienced at least physical symptom of burnout in the previous weeks. increased irritability, change in food habits, difficulty falling asleep, and muscle tension were frequently experienced by the majority of respondents ( ) . one covid- study showed twice the rates of anxiety and depression in frontline providers compared with nonclinical staff ( ), whereas a sars study showed psychiatric morbidity in hospital workers to be times higher than the general population ( ) . nurses may be more likely than other clinicians to show symptoms of posttraumatic stress ( ) . loss of professional control-for example, due to changes in work assignment or work security-is associated with high levels of distress ( ) . a perception of inadequate institutional support, as reflected by feedback from frontline staff not reaching hospital administrators, inadequate health care insurance or compensation, or insufficient psychological support from employers, were all risk factors for poor mental health ( ) . tools for routine assessment of mental health status, such as zung's self-rating depression scale and self-rating anxiety scale for self-monitoring ( - ); training health care workers to identify physical, behav-ioral, emotional, and cognitive indices of distress in themselves and colleagues; and regular visits from mental health clinicians to assess the well-being of frontline providers are needed ( , , ) . studies of previous pandemics demonstrate heightened distress in health care workers more than years after the event ( ). however, covid- presents challenges not seen in previous pandemics, including a protracted timeline, severe financial implications, and a global scale. as a result, its effects on the mental health of health care workers can be expected to exceed those observed in previous pandemics. proactive mental health support for health care providers is essential for protecting their long-term mental health ( ) . in conclusion, clinicians require proactive psychological protection specifically because they are a population known for putting others' needs before their own. to mitigate the known psychological costs of providing care during a pandemic and recovering from associated experiences, comprehensive institutional and societal infrastructure for clinician well-being is needed, especially as we enter this unprecedented, global postpandemic era. this support should target resilience and stress reduction training, ensure that clinicians' basic needs are met, provide routine opportunities for social connection, and proactively normalize and deliver mental health care to clinicians. top e.r. doctor who treated virus patients dies by suicide mondello kills himself after less than three months on the job clinician mental health and wellbeing during global healthcare crises: evidence learned from prior epidemics for covid- pandemic understanding and addressing sources of anxiety among health care professionals during the covid- pandemic psychological impact and coping strategies of frontline medical staff in hunan between preventing a parallel pandemic-a national strategy to protect clinicians' well-being long-term psychological and occupational effects of providing hospital healthcare during sars outbreak psychological impact of severe acute respiratory syndrome on health workers in a tertiary hospital the physical and mental health challenges experienced by / first responders and recovery workers: a review of the literature occurrence, prevention, and management of the psychological effects of emerging virus outbreaks on healthcare workers: rapid review and meta-analysis alliance for academic internal medicine. wellness and resiliency: charm. accessed at www.im.org/resources/wellness-resiliency /charm on charter on physician well-being general hospital staff worries, perceived sufficiency of information and associated psychological distress during the a/h n influenza pandemic factors associated with the psychological impact of severe acute respiratory syndrome on nurses and other hospital workers in toronto psychological impact of the severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in singapore survey of stress reactions among health care workers involved with the sars outbreak factors associated with mental health outcomes among health care workers exposed to 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medical staff in china during the covid- outbreak attending to the emotional wellbeing of the health care workforce in a new york city health system during the covid- pandemic mental health care for medical staff and affiliated healthcare workers during the covid- pandemic nurturing morale the psychological impact of quarantine and how to reduce it: rapid review of the evidence assessing the skillset of surgeons facing the covid- pandemic healthcare workers emotions, perceived stressors and coping strategies during a mers-cov outbreak moral injury and moral repair in war veterans: a preliminary model and intervention strategy covid- and experiences of moral injury in front-line key workers the effects of social support on sleep quality of medical staff treating patients with coronavirus disease (covid- schwartz rounds for healthcare personnel in coping with covid- pandemic -ncov epidemic: address mental health care to empower society accessed at www.physiciansupportline accessed at https ://suicidepreventionlifeline.org on crisis text line. accessed at www.crisistextline.org on a mindfulness course decreases burnout and improves well-being among healthcare providers accessed at www.headspace.com/health-covid- on accreditation council for graduate medical education. accessed at www.acgme.org/what-we-do /initiatives/physician-well-being/aware-well-being-resources on national academy of medicine resources to support the health and well-being of clinicians during the covid- outbreak covid- ) covid- pandemic response resources. accessed at www.cstsonline.org/resources /resource-master-list/coronavirus-and-emerging-infectious-disease -outbreaks-response on may . . intensive care society. wellbeing and psychological resource library. accessed at www.ics psychological impact of the mers outbreak on hospital workers and quarantined hemodialysis patients burnout and somatic symptoms among frontline healthcare professionals at the peak of the italian covid- pandemic psychological status of medical workforce during the covid- pandemic: a cross-sectional study screening for chinese medical staff mental health by sds and sas during the outbreak of covid- a rating instrument for anxiety disorders. psychosomatics from art to science. the diagnosis and treatment of depression prevalence of self-reported depression and anxiety among pediatric medical staff members during the covid- outbreak in guiyang impact on mental health and perceptions of psychological care among medical and nursing staff in wuhan during the novel coronavirus disease outbreak: a cross-sectional study current author addresses: dr. schwartz: pasteur drive, mc mayo clinic college of medicine and science, office of student services margolis. administrative, technical, or logistic support: r. schwartz, r.d. margolis. collection and assembly of data the authors thank eugenie heitmiller, md, faap; tait shanafelt, md; stuart slavin, md, med; and larissa thomas, md, mph, for reviewing and providing useful feedback on the manuscript. they also thank their colleagues in the charm network for gathering and sharing the well-being resources featured in the article. authors have disclosed no conflicts of interest. forms can be viewed at www.acponline.org/authors/icmje /conflictofinterestforms.do?msnum=m - . key: cord- - tng authors: wolpert, miranda title: prioritising global mental health: a photo paints a thousand words date: - - journal: the lancet psychiatry doi: . /s - ( ) - sha: doc_id: cord_uid: tng nan in december, , when the wellcome photography prize was launched, i wrote that i was "hoping for images that will help provide a more nuanced picture of how people live with, or recover from, mental health problems". the shortlisted images have exceeded my expectations. the prize aims to challenge preconceptions and stereotypes, and provide a more authentic look at peoples' experiences of health. in viewing the shortlisted photographs focused on mental health, i found myself both moved and excited by the creativity and honesty of the photographs. while they focused particularly on those with more enduring difficulties, they spoke to me of the strength and fragility of us all as we each find our own ways to manage our own mental health. here, i will focus on a shortlisted entry that closely links to wellcome's mental health strategic priority focus on identifying those "active ingredients" that really make a difference in addressing or managing anxiety and depression in young people worldwide. this is part of our mission to find the next generation of treatments and approaches to transform the lives of the millions of people who are currently being held back by anxiety and depression. in mental health kits, the photographer, sebastian mar of moscow, captures a series of portraits of four young russian women with mental health issues alongside a collection of objects that form part of their experience of mental health problems. mar comments: "in all creative work i produce, i explore the intense emotions and experiences which usually deny articulation, such as trauma, delusion, and dreams. perhaps driven by my own struggles with other people's denial of the reality of my illness, i search for ways to speak the unspeakable. photography, in my view, may be one of the most effective mediums for battling prejudice and distrust: what is expressed in words is often cast aside as a product of fancy, or something too difficult to comprehend, but photographs persuade with their ability to capture the world as it is, bypassing the process of human interpretation." this work brings to life, in ways in which it is hard to do in words, the rich diversity of people's approaches to managing their own mental health in the context of "trauma, delusion and dreams". each kit is as individual as its creator. for example, for ksusha, a computer technician at a liberal political party, who identifies as someone with bipolar disorder, her kit includes video gaming and ice-hole diving, while for seva, a fashion photography student and poet who identifies as having chronic depression and anxiety disorder, her kit includes both poetry and pills. as mar notes, "each of these kits is a manifestation of hope and resourcefulness". it is notable that these images come from russia, which is one of the less visible areas of the world in terms of mental health science output. as part of our work at wellcome, we are seeking to extend mental health science beyond the small number of western, educated, industrialized, rich, and developed (sometimes referred to as weird) contexts in which most research is currently conducted. while being rooted in their specific context, these images are relatable worldwide. in response to the covid- pandemic, the hashtag #threefor sprang up on twitter, in which people shared three things that were helping their mental health. many people shared elements of their mental health kits. perhaps it would be beneficial to all of us to map out our own mental health first aid kit. these images turn the complex issues of how people live with mental health issues into strong visual narratives. we hope that they will help spark further discussion and exploration of what works for whom and why, so that we can all take one step closer to a world where no one is held back by mental health problems. the winner of the wellcome photography prize will be announced on aug , . the full shortlist gallery is available to view at https://wellcome.ac.uk/ what-we-do/our-work/ wellcome-photographyprize/ wood burner to smell wood. ( ) a wiccan book to follow the wheel of the year. ( ) socks to observe glittering sebastian mar / wellcome photography prize insight www mental health kit: katerina ( ) toy spiders to hug during anxiety attacks. ( ) other people's photos, found at fleamarkets a poem from a long-distance friend. ( ) a photograph of k's parents, to feel inspired to live key: cord- -wm y lts authors: george, m. patricia; maier, lisa a.; kasperbauer, shannon; eddy, jared; mayer, annyce s.; magin, chelsea m. title: how to leverage collaborations between the bme community and local hospitals to address critical personal protective equipment shortages during the covid- pandemic date: - - journal: ann biomed eng doi: . /s - - - sha: doc_id: cord_uid: wm y lts the global covid- pandemic disrupted supply chains across the world, resulting in a critical shortage of personal protective equipment (ppe) for frontline healthcare workers. to preserve ppe for healthcare providers treating covid- positive patients and to reduce asymptomatic transmission, the department of bioengineering at the university of colorado, denver | anschutz medical campus collaborated with national jewish health to design and test patterns for cloth face coverings. a public campaign to sew and donate the final pattern was launched and over face coverings have been donated as a result. now that nearly three million cases of covid- have been confirmed in the united states, many state and local governments are requiring cloth face coverings be worn in public. here, we present the collaborative design and testing process, as well as the final pattern for non-patient facing hospital workers and community members alike. the world health organization (who) designated the covid- outbreak as a global pandemic on march , . by march , frontline healthcare workers already reported critical shortages of personal protective equipment (ppe) including respiratory protection, gloves, face shields, gowns, and surgical masks. in the united states, the food and drug administration (fda) regulates medical respirators and surgical masks. these products must pass national institute for occupational safety and health (niosh) performance testing and be cleared for sale by submission of a premarket notification under section (k) of the food, drug and cosmetic act. breakdown in the global supply chain of ppe and the resulting critical shortages led the fda to release guidances allowing ''use of improvised ppe when no alternatives, such as fda-cleared masks or respirators, are available''. simultaneously, the centers for disease control and prevention (cdc) recommended the use of face coverings by all people when out in public. the official policy at national jewish health in denver, colorado focused on ensuring that certified ppe was preserved for frontline healthcare providers treating patients, including suspected or confirmed covid- patients and other patients at high risk for contracting covid- . as a result, a significant need was identified to provide face coverings for a diverse group of non-patient-facing staff members, including non-clinical faculty, administrators, cafeteria workers, and valets. local sewing groups began quickly ramping up efforts to produce and donate cloth face coverings in response. unfortunately, these local volunteers did not realize that there are nuances that influence the efficacy of cloth face coverings that must be considered when selecting a pattern and materials. to best address the need for an optimal cloth face covering design, a multidisciplinary collaboration among pulmonary medicine, occupational medicine, and bioengineering was formed to rapidly evaluate cloth face covering designs. a public campaign to produce cloth face coverings for staff members at the hospital using the approved design was launched within days. in this letter, we describe the framework for introducing improvised ppe into a clinical setting during a crisis. we include previous studies that supported decisions for fabric type, the prototyping and fit-testing process, the feedback from occupational health experts and other physicians, and the final approved design. after sharing this pattern with our community, national jewish health received donations of over cloth face coverings for staff members in non-high-risk settings in an effort to reduce the risk of asymptomatic transmission. even though the design and production of improvised ppe does not require an engineering degree, it is critical that this product, like any other medical device, be constructed through close collaboration between the designers and the clinicians who will eventually use the product. led by a faculty member in the university of colorado, denver | anschutz medical campus department of bioengineering with experience in the medical device industry, a pulmonary and critical care physician working on the frontlines to treat covid- + patients, and an occupational medicine physician with expertise in respirator use and conservation both at national jewish health in denver, our team produced prototypes of four publicly available cloth face covering patterns (table ) . all prototypes were constructed using two layers of tightly woven cotton cloth. the inner and outer layers were two visually different materials to ensure that wearers could easily tell the difference between the inside and outside of the mask. a study by davies et al. evaluated the efficacy of common household materials in blocking transmission of bacterial and viral aerosols. results showed that surgical masks filtered bacteriophage ms , the viral surrogate, with approximately % efficiency, while two layers of % cotton had a mean filtration efficiency of about %. based on these results and the availability of cotton fabric, we concluded that face coverings must be made from two layers of tightly woven, % cotton fabric, similar to what quilters use regularly. the four prototypes were selected so that the occupational medicine physicians and respirator fit specialists at national jewish health could compare and evaluate three main design features: overall mask shape, conformation to the nasal bridge and jawline, and the method for securing the mask. the deaconess (fig. a) and we can sew it! (fig. b) represent a pleated mask shape while the florence face mask (fig. c) and diy cloth mask (fig. d) designs are rounded. the we can sew it! and diy cloth mask patterns featured the inclusion of a small wire along the nose bridge. the deaconess and diy cloth mask were both secured with elastic loops while the we can sew it! and florence face mask designs were secured with fabric ties. prototypes were evaluated for seal, fit, and breathability. feedback on the various design features is summarized in table . in response to this feedback, a designer and sewer selected the diy cloth mask pattern, which featured a rounded mask shape and nasal bridge wire, and altered the original pattern to address concerns from the occupational medicine physicians and respirator fit specialists at national jewish health. the nose-to-chin length was increased, a short piece of elastic was added to the bottom for improved conformation to the jawline, and a novel system for securing the face covering using adjustable ties made from macrame´cord or twill instead of static ties overcame the limitations of previous designs (fig. ) . ties that secured over the head allowed for a snugger fit than ear loop ties. this design was used to create a second round of prototypes delivered to the hospital for evaluation. ten volunteers, including doctors, nurses, and echocardiography technicians, wore these masks for at least h before providing feedback. overall comments were positive. mask wearers remarked, ''the mask fits great,'' and ''i could wear it all day long and breathe''. we set out to design improvised ppe that could be fabricated locally by volunteers and would meet the requirements of a local hospital when supply chains failed to deliver certified face masks. the final design, evaluated and approved by the occupational medicine and infectious disease groups at national jewish health, is available online (link: https://www.nationa ljewish.org/patients-visitors/patient-info/important-up dates/coronavirus-information-and-resources/additio nal-resources/making-masks-for-health-care-workers). this website includes a pattern and tutorial for sewing the approved design, best practices for wearing and maintaining cloth face coverings, answers to frequently asked questions, and instructions for making donations. the collaborative effort between the bme community and our local hospital described here resulted in the launch of the website and public campaign to sew and donate approved masks in fewer than days. as of today, over cloth masks have been donated to national jewish health and provided to staff members in non-high-risk settings with the goal of reducing the risk of asymptomatic transmission of covid- . national jewish health has achieved and maintained face coverage for % of employees. currently states have some form of mandate requiring cloth face coverings be worn in public spaces. the design and materials outlined here are also ideal for community members to use in compliance with these requirements. testing the efficacy of homemade masks: would they protect in an influenza pandemic? in: guidance for industry and food and drug administration staff, edited by the u.s. department of health and human services food and drug administration center for devices and radiological health strategies for optimizing the supply of facemasks critical supply shortages-the need for ventilators and personal protective equipment during the covid- pandemic publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors would like to thank marilou goodwin, karen gilbert, seth drake, amber platt, jonathan platt, marti freeman, stephanie alarcon, anna elmore, lana durkee, and jason vernon for their contributions to face covering design, sewing, and tutorial preparation. thank you to david wilson for demonstrating the proper way to wear cloth face coverings in fig. . key: cord- - cnuem authors: wong, anna s. y.; kohler, jillian c. title: social capital and public health: responding to the covid- pandemic date: - - journal: global health doi: . /s - - -x sha: doc_id: cord_uid: cnuem background: as countries continue to respond to the covid- pandemic, the importance of ensuring that fair and equal access to healthcare for all is more urgent than ever. policies that promote social capital building along all levels of society may offer an important avenue for improved healthcare delivery and health systems strengthening in the covid- response. main body: in reference to the established and emerging literature on social capital and health, we explore the role of social capital in the covid- health policy response. we analyse current research with respect to mental health, public health policy compliance, and the provision of care for vulnerable populations, and highlight how considerations of bonding, bridging, and linking capital can contribute to health systems strengthening in the context of the covid- response and recovery effort. conclusions: this article argues that considerations of social capital – including virtual community building, fostering solidarity between high-risk and low-risk groups, and trust building between decision-makers, healthcare workers, and the public – offer a powerful frame of reference for understanding how response and recovery programs can be best implemented to effectively ensure the inclusive provision of covid- health services. the global response to covid- has required decisiveness, resilience, and resolve from governments around the world. however, economic, legal, technological, geographic, and cultural barriers can limit the ability of a government to effectively respond to critical public health needs. the intricate network of stakeholders that operate within and interconnect with the public health space is an essential component of a health system's response. in this context, considerations of social capital emerge as a powerful frame of reference for understanding how health interventions may be best implemented to effectively ensure an inclusive extension of health services for all members of society. it is patently clear that if a population group is excluded from accessing the health system and its attendant services and products, the efficacy of any pandemic response or recovery program may be severely undermined. putnam conceptualizes social capital as the behaviour of social networks and relationships, characterized by the qualitative presence of enhanced trust and reciprocity [ ] . within the field of public health, social capital has been studied by many scholars as both a variable to improve health outcomes and as a framework for assessing public health interventions [ ] . bonding, bridging, and linking capital describe three sub-types of social capital that are particularly prescient in the context of public health studies. bonding capital describes the social capital derived from the social networks and relationships within homogenous groups, bridging capital from those within heterogeneous groups comprised of members of equal power or authority ('horizontal' capital), and linking capital from those within heterogeneous groups comprised of members ordered along an explicit, formal, or institutionalized gradient of power or authority ('vertical' capital) [ ] . expressed through the creation of cultures of obligation or expected reciprocity, enhanced community-based information channels, or the establishment of informal codes of socially normative behaviour, social capital may benefit members of a community by encouraging solidarity, expediting knowledge dissemination, and facilitating the social integration of previously excluded members [ ] . as countries adopt urgent public health measures in response to the many challenges posed by covid- , lessons learned from public health intervention studies that link enhanced social capital with improved mental health outcomes, greater community buy-in, and the extension of health services to vulnerable populations suggest a critical role for social capital in ensuring a rapid adjustment to today's new public health reality. preliminary studies conducted in the united states lend support to the importance of social capital in the covid- response, with the growth rate of new covid- cases found to be negatively associated with the amount of social capital at both the state and county levels [ ] . however, explicitly seeking to employ or strengthen existing social networks for the purpose of improved health outcomes demands thoughtful consideration as to the nature of each intervention group's social layout. distinct structures of social interaction may behave differently in response to a particular public health intervention, and thus, it is imperative that a social capital-based response maintain the capacity to not only recognise scenarios in which social capital building initiatives may effectively complement the public health agenda, but also accurately identify the subtypes of social capital already present within communities. in this way, a social capital-centric public health approach to the covid- response should not be understood as a onesize-fits-all policy supplement, but rather, as a framework for understanding how the social dynamics between discrete groups of actors can be employed to most efficiently implement pandemic-related health policies. in countries around the world, social distancing policies have emerged as a central component of the covid- response. measures including post-exposure quarantining, shelter-in-place orders, and limits on the size of social bubbles have been credited with 'flattening the curve' and reducing the growth of new infection cases. however, these have also contributed to the dramatic disruption of normal patterns of social interaction, raising serious mental health concerns amongst the general population and high-risk groups alike. as social distancing measures continue to limit access to customary channels of social supportsuch as spending in-person time with family members, friends, and colleagues of different householdsstudies within communities affected by covid- report consistent observations of elevated mental health concerns. for example, heightened levels of anxiety and depression have been reported in china, greater stress and mental morbidity have been observed in iran, higher levels of fear and panic behaviour have been noted in japan, and increased health anxiety has been studied in canada [ ] . addressing the potential mental health consequences of social distancing measures thus necessitates a conscious inclusion of psychological interventions in the international pandemic response. this is particularly true for high-risk groups, such as the elderly, those with underlying health conditions, and front-line health workers, since these groups represent the populations that are most likely to adhere to stricter forms of social distancing [ ] . in this respect, robust bonding capital between physically distant family and community members may help insulate high-risk individuals from social isolation by preserving their pre-existing social networks. efforts that consciously seek to promote virtual or physically distant community building thus stand as immediately available options to mitigate against potential adverse mental health responses to social distancinginduced isolation. similarly, with social distancing increasingly being treated as a long-term policy contingent on the development and delivery of a successful covid- vaccine, it is imperative that the public health response recognise the increased likelihood of social dislocation among individuals and communities with weak bonding capital, and thus, their enhanced risk of experiencing adverse mental health outcomes. effectively containing the spread of covid- demands a unified response from all members of society. this is particularly true with respect to preventative public health measures that intrinsically require broad public buy-in, such as physical distancing or public maskwearing. however, with some groups of individuals perceived to be at significantly lower risk to the most severe symptoms of covid- , psychological tolerance to reduced levels of precaution may vary considerably within a given population. if expressed through the refusal to comply with public health directives, the efficacy of preventative public health measures may be severely undermined. in this way, perhaps one of the most challenging obstacles to achieving public health policy compliance in the context of covid- lies in persuading individuals to make decisions according to the exposure tolerance of high-risk individualspotentially to whom they have no personal connectionrather than according to their own personal willingness to incur risk. indeed, while full public buy-in to public health directives is an undoubted prerequisite to an effective pandemic response, communities with weak bridging capital between high-risk and low-risk populations may find this difficult to achieve. initiatives that aim to build social capital by fostering enhanced solidarity and empathy between high-risk and low-risk groups are thus particularly important to the covid- response. a recent set of studies investigating the role of empathy on physical distancing and mask-wearing compliance reinforces the potential impact of such initiatives, finding that public motivation to adhere to these preventative public health measures is promoted when empathy for those most vulnerable to covid- is elicited [ ] . extended to the future delivery of a covid- vaccine, an emphasis on the collective remains imperative; policies that deliberately seek to build bridging capital between high-risk and low-risk groups may serve as an effective tool to combat vaccine hesitancy by enabling members of the general population to recognise that their personal immunization decisions intimately influence the safety of those in their communities who are unable to be vaccinated (ex. due to allergic intolerances). in comparison to authoritarian systems of government, where public adherence to strict pandemic response measures may be unilaterally compelled through the use or threat of excessive force, compliance with government-mandated health directives among democratic systems requires that the public embrace a set of pro-health social norms that can weather the spread of scientifically unsupported information and/or a lack of trust in national health leaders. measures that protect linking capital between democratic public health authorities and members of the public thus cannot not be overlooked. to this end, the dissemination of transparent and accurate public health information, enforcing expectations of public health policy compliance among political leaders, policy consistency between domestic agencies and departments, and policy congruency with recognized international health organizations stand as actionable social capital-centric options that may enhance public faith in the legitimacy of national covid- responses. equally important is the role of linking capital in ensuring that the needs of the vulnerable are not ignored. particularly in the context of the current covid- pandemic, it is vital that individuals can access lifesaving health services regardless of their socioeconomic or legal status, cultural identity, or geographic location. in italy, the exclusion of irregular migrants from receiving free covid- testing was shown to undercut the government's pandemic response [ ] , illustrating the importance of an inclusive, equitable, and population-wide approach to the covid- health response. in the united states, a fear of legal reprisal has been identified as a potential deterrent to care among undocumented immigrants [ ] , further underscoring the importance of actively seeking to include the 'invisible' members of society when formulating public health policy. a previous study of linking capital in spain demonstrated how nurses with low financial resources could be used to increase trusting relationships between irregular migrants and healthcare providers to increase the overall accessibility of healthcare services [ ] . with respect to the covid- response, which demands resilience across all levels of the health system, this suggests the particularly powerful role of linking capital in extending the accessibility of both general and pandemic-related health services to members of vulnerable or marginalized communities. a social capital-centric public health response is one that recognises the limitations of top-down policy and the value of social networks in achieving desirable public health outcomes. as concerns over mental health, public health policy compliance, and equitable access to healthcare services and products continue to confront the global covid- response, measures that integrate considerations of bonding, bridging, and linking capital stand as immediately available options for health systems strengthening. efforts to address the ongoing pandemic increasingly demand the participation of actors across different nationalities, disciplines, socioeconomic backgrounds, and political identities. as such, we must acknowledge the inherent importance of social solidarity and trust in achieving today's urgent public health goals. author's information anna wong is a research assistant at the world health organization collaborating centre for governance, accountability and transparency. jillian c. kohler is the director of the world health organization collaborating centre for governance, accountability and transparency, and a professor at the university of toronto leslie dan faculty of pharmacy, dalla lana school of public health, and munk school of global affairs and public policy. she is also a connaught scholar ( ). background research for this paper was supported by the canadian institute for health research. data sharing is not applicable to this article as no datasets were generated or analysed during the current study. ethics approval and consent to participate not applicable. not applicable. health by association? social capital, social theory, and the political economy of public health social capital and health in the least developed countries: a critical review of the literature and implications for a future research agenda social capital in the creation of human capital covid- growth rate decreases with social capital covid- and mental health: a review of the existing literature mental health and the covid- pandemic the emotional path to action: empathy promotes physical distancing and wearing face masks during the covid- pandemic covid- : universal health coverage now more than ever undocumented u.s. immigrants and covid- caring for the unseen: using linking social capital to improve healthcare access to irregular migrants in spain tessa senneker and doret cheng are acknowledged for their prior background research which helped inform this commentary.authors' contributions aw identified and analysed literature on social capital and covid- , and was the primary contributor in writing the manuscript. jk established the scope of the manuscript and substantively revised it. the author(s) read and approved the final manuscript. the authors declare that they have no competing interests.received: july accepted: september key: cord- -kqbeinez authors: boyce, matthew r.; katz, rebecca title: community health workers and pandemic preparedness: current and prospective roles date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: kqbeinez despite the importance of community health workers (chws) to health systems in resource-constrained environments, relatively little has been written about their contributions to pandemic preparedness. in this perspective piece, we draw from the response to the ebola and zika epidemics to review examples whereby chws contributed to health security and pandemic preparedness. chws promoted pandemic preparedness prior to the epidemics by increasing the access to health services and products within communities, communicating health concepts in a culturally appropriate fashion, and reducing the burdens felt by formal healthcare systems. during the epidemics, chws promoted pandemic preparedness by acting as community-level educators and mobilizers, contributing to surveillance systems, and filling health service gaps. acknowledging the success chws have had in these roles and in previous interventions, we propose that the cadre may be better engaged in pandemic preparedness in the future. some practical strategies for achieving this include training and using chws to communicate one health information to at-risk communities prior to outbreaks, pooling them into a reserve health corps to be used during public health emergencies, and formalizing agreements and strategies to promote the early engagement of chws in response actions. recognizing that chws already play a role in pandemic preparedness, we feel that expanding the roles and responsibilities of chws represents a practical means of improving pandemic and community-level resilience. disasters are unexpected events that imply serious health, economic, or political threats, and require special considerations beyond routine procedures or resources. large-scale infectious disease outbreaks, therefore, represent one manifestation of such events. importantly, these disease outbreaks appear to be increasing in frequency ( ) , and this year alone, there have been outbreaks of cholera, ebola, lassa fever, middle east respiratory syndrome, nipah, rift valley fever, and yellow fever ( ) . promoting disaster resilience represents one approach to mitigate the consequences of disasters. the sendai framework for disaster risk reduction describes disaster resilience as the ability of an entity to resist, acclimate to, and recover from the effects of a hazard, including through the preservation and restoration of essential structures and functions. disaster resilience theory further categorizes resilience as being either inherent or adaptive ( ) , with inherent resilience referring to the conditions, characteristics, and properties associated with absorptive capacity; and adaptive resilience involving the activation of resources and blending preplanned and reactive actions in response to disaster-related demands. the international health regulations (ihr) and the corresponding joint external evaluation tool (jee) are the preeminent international frameworks for building and assessing resilient public health systems. these assigned new responsibilities to the world health organization (who) and nations to share resources, information, and expertise to build capacities to help prepare the world for preventing, detecting, and responding to health emergencies. to this end, the jee tool states that countries should have a skilled and competent workforce of physicians, veterinarians, biostatisticians, laboratory scientists, livestock professionals, and field epidemiologists for maintaining sustainable public health surveillance and response mechanisms. still, this guidance prescribes a national-level workforce and assumes that capacity will be dispersed throughout a country. this assumption is rarely a reality, particularly in lowresource or unstable regions where healthcare workforces may be concentrated in wealthier areas of a country. although the recently released jee . places greater emphasis on building subnational level capacities ( ), the impacts of this reality are acutely felt at the community-level during public health crises where health systems assets can be limited or nonexistent. community health workers (chws)-lay persons trained to assist in the communication or provision of health servicesrepresent one method for extending health services at subnational levels, particularly in underserved or remote populations ( ) . chws are commonly trained in the context of health interventions to carry out defined functions related to healthcare delivery, but rarely have formal professional or paraprofessional certifications, or degreed tertiary education ( ) . chws have traditionally been used to improve community health initiatives, manage the risk of infectious diseases (e.g., malaria, pneumonia, and tuberculosis), and fill gaps in healthcare systems. accordingly, much attention has focused on their importance to primary healthcare systems. however, despite their establishment at the community level, chws are often under-utilized in the response to infectious disease outbreaks ( ) and additional roles for chws in promoting pandemic preparedness exist. the who has released training materials for preparing chws to respond to respiratory disease outbreaks ( , ) but relatively little attention has been given to their potential importance in contributing to the prevention and control of other large-scale infectious disease outbreaks. despite this, chws have been involved in the response to these events. at least chws were involved in liberia's response to the ebola outbreak ( ) and over , chw were involved in côte d'ivoire's precautionary response to the ebola outbreak in neighboring guinea and liberia ( ) . acknowledging the importance of chws in extending health services to vulnerable populations filling health system gaps, as well as their involvement in previous outbreaks, herein we discuss several roles chws currently play in promoting inherent and adaptive resilience and discuss future opportunities for chws to better sub-national pandemic preparedness and response. from a public health perspective, inherent resilience could include adequate nutrition, access to clean water, effective sanitation systems, robust health systems, and other means buffering populations against public health emergencies. accordingly, perhaps the most discernible role of chws in pandemic preparedness is inherent to the position-one of increasing the access to health interventions and services within communities (box ). these efforts can reduce the risk of many morbidities and overall mortality ( ) and improve the underlying population health, in theory, reducing the susceptibility of the population to infectious disease threats. another role chws currently fill in promoting inherent resilience is the distribution of culturally appropriate health information and supplies. in the midst of the zika outbreak, chws known as "brigadistas" were used to communicate important information regarding zika to reduce the risk of infection in at-risk communities prior to the peak of mosquito season ( ) . this proactive strategy improved community awareness about the importance of eliminating mosquito breeding sites and promoted condom use to reduce sexual transmission of the virus. brigadistas were also used to distribute zika prevention kits-containing barrel covers, bed nest, condoms, and educational materials-to pregnant mothers. finally, chws can act as a community-level triage systemtreating those with minor illness and referring those with more serious disease. this reduces pressures on often over-burdened health systems and helps to ensure that formal healthcare cadres-those referenced in the ihr and jee tool-are available to provide health services to those most in need. for example, in brazil, chws have been used to triage conditions and provide basic primary care to families to resolve minor ailments ( ) . in the event of severe issues, they were trained to refer patients to nurses or physicians who were better equipped to manage illness. ultimately, this strategy reduced the number of hospitalizations and led to significant improvements in clinical outcomes-both with regard to mortality and improving access to healthcare. with regard to pandemic preparedness, the adaptive resilience roles of chws are more complicated. although chws receive box | selected community health worker roles that promote inherent resilience. • increase the access to health services and products within communities to improve population health and reduce the likelihood of an outbreak • communicate important public health concepts in a culturally appropriate fashion • reduce the burden felt by formal healthcare systems and improve the quality of clinical care frontiers in public health | www.frontiersin.org healthcare-related training, expecting or obligating them to medically respond to a large-scale infectious disease outbreak is unethical and impractical. the disproportionate effects of outbreaks on healthcare workers-as seen in the sars ( ) and ebola outbreaks ( )-are likely to rapidly decimate the healthcare workforce resulting in a reluctance to work and in high rates of absenteeism ( ) . chws are not exempt from this trend ( ) . still, medical tasks are fundamentally different from other essential response tasks-the former require technical proficiencies, whereas the latter can rely on social competencies, communication skills, and local-level knowledge ( ) . it is in these non-medical roles that chws can excel in contributing to the adaptive resilience of health systems (box ). community health workers often represent a trusted voice in the community and thus also represent valuable assets for social mobilization and the distribution of health information during outbreaks. a key lesson from the ebola outbreak response was that engaging communities to contain the spread of disease can be challenging unless there was an existing network of healthcare workers embedded within communities ( , ) . because chws reside in or near the communities they service, they are uniquely positioned to act as communitylevel educators, organizers, and mobilizers in this network. indeed, during the ebola response, engaging chws in response procedures improved the efficacy of response activities ( ) . another adaptive role that chws contribute to is disease surveillance. depending on the locale from which an outbreak occurs, chws could be on the frontlines of responding to a public health emergency and having systems in place for chws to report unusual symptoms or epidemiological patterns while performing their routine activities could enhance syndromic surveillance. this role was validated in côte d'ivoire ( ) and sierra leone ( ) during the ebola epidemic where chws conducted community surveillance activities and reported suspected ebola cases to public health authorities. chws can also promote adaptive resilience by resuming their medical roles and filling health service gaps following outbreaks. this role is of great importance should healthcare workforces be depleted by an outbreak response. scholars have noted that sustained political and financial investment in chw programs could create a solid foundation for chws to close sudden or unexpected health system gaps and improve the resilience of health systems ( ) . box | selected community health worker roles that promote adaptive resilience. • act as community-level educators, organizers, and mobilizers during infectious disease outbreaks • contribute to syndromic disease surveillance systems while completing routine activities • complete medical tasks unrelated to the infectious disease outbreak to fill health service gaps during or following the outbreak. given these roles in promoting resilience, better involving chws in pandemic preparation efforts appears both logical and practical. there have been direct calls for sustained investment in health worker training, which could include chws, to mitigate the risks posed by disease outbreaks ( , ) and considering the potential contributions of chws in containing public health emergencies, scaling-up chw strategies could avoid an estimated $ million in economic losses per year ( ) . we now propose several actionable options for improving chw trainings and involvement in health emergency response to better promote pandemic preparedness. first, since chws play a key role in providing health services, and often work on a voluntary basis, their personal satisfaction, and motivation are central to their involvement in health interventions. while much work has investigated chw's motivations for routine activities ( ) ( ) ( ) ( ) ( ) , less evidence exists regarding chws motivations, satisfaction, and role perception when providing services in environments that warrant special considerations (e.g., during an outbreak). conducting qualitative research with chws regarding their motivations, perceptions, experience, and concerns about working during an infectious disease outbreak could inform larger policy decisions. given that a majority of emerging infectious diseases are zoonotic in origin ( ) , and acknowledging chws' competence in communicating important health concepts in a sensitive and culturally appropriate fashion, chws could also be used to develop and promote one health messaging campaigns. doing so could improve inherent resilience by leading to more successful behavioral change campaigns and increased awareness of the risks posed by environmental intrusion, bushmeat consumption, and other factors that promote infectious disease spillover events. third, chws could be used to promote adaptive resilience by serving as a type of reserve heath corps during public health emergencies. as detailed earlier, this role should be not medical which could expose chws to unnecessary risks, but one rooted in social mobilization. engaging chws in national risk communication strategies and plans could act to simultaneously expand the reach of communication networks and enhance the perceived validity of the information dispersed by them. this could help to reduce the risk of misinformation and rumors that can lead to fear, social unrest, and violence during an outbreak response. finally, studies have shown that the late engagement of chws can hinder an outbreak response ( ) . thus, formalizing or developing agreements that quickly engage chws during public health emergencies could improve overall response procedures and improve adaptive resilience. at a minimum, the experience, local-level knowledge, and relationships of chws could help to inform and guide higher-level efforts, but clearly defining chw roles and expectations in an outbreak response would bolster response activities. this is especially true in less-permissive environments, where high levels of mistrust are common and chws social standing can provide them with some level of protection. indeed, chw programs in the central african republic demonstrated that they could continue some level of care at all times, reach those most vulnerable populations, and maintain disease surveillance activities even in conflict zones ( ) . the guidance outlined in the ihr and jee tool provides a framework to promote global health security and pandemic preparedness where capacities already exist. however, access to these capacities is not always a reality, and chws represent a proven strategy for improving access to healthcare. through their routine work, chws contribute to inherent resilience and pandemic preparedness by increasing access to health products and services, distributing health information, and reducing the burden felt by the formal healthcare system-all of which act to buffer against emergencies. chws can also contribute to adaptive resilience by increasing social mobilization, completing surveillance activities, and by filling health systems gaps left in the wake of infectious disease outbreaks. recognizing that chws already play a role in pandemic preparedness, the roles and responsibilities of chws in pandemic preparedness could be expanded to improve health security and communitylevel resilience. mb contributed to the conception and design of the manuscript and wrote the first draft of the manuscript. rk made substantial contributions to the conception of the manuscript. both of the authors contributed to manuscript revision, and have read and approved the submitted version. global rise in human infectious disease outbreaks available online at the social roots of risk: producing disasters, promoting resilience capacity building under the international health regulations: ramifications of new implementation requirements in second edition joint external evaluation community health workers: what do we know about them? geneva: who lay health workers in primary and community healthcare community health workers during the ebola outbreak in guinea, liberia, and sierra leone community case management during an influenza outbreak: a training package for community health workers infection-control measures for healthcare of patients with acute respiratory diseases in community settings community health workers during the ebola 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after the - ebola outbreak expanding nursing's role in responding to global pandemics strengthening primary healthcare strengthening primary healthcare through community health workers: through community health workers: investment case and financing recommendations using theory and formative research to design interventions to improve community health worker motivation, retention and performance in mozambique and uganda a qualitative review of implementer perceptions of the national community-level malaria surveillance system in southern province motivation and satisfaction among community health workers in morogoro region, tanzania: nuanced needs and varied ambitions assessing the impact of community engagement interventions on health worker motivation and experiences with clients in primary health facilities in ghana: a randomized cluster trial motivations for entering and remaining in volunteer service: findings from a mixed-method survey among hiv caregivers in zambia global trends in emerging infectious diseases community matters-why outbreak responses need to integrate health promotion malaria case management by community health workers in the central african republic from - : overcoming challenges of access and instability due to conflict the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.copyright © boyce and katz. this is an open-access article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- -ocd ojnc authors: boggio, andrea title: human rights and global health emergencies preparedness date: - - journal: journal of global health doi: . /jogh. . sha: doc_id: cord_uid: ocd ojnc nan t he spread of infectious disease is always ranked high as a global threat. it features prominently among the list of urgent health challenges for the next decade, issued in early january by who [ ] . the emergence of the novel coronavirus in the hubei province in china, is a reminder of global health vulnerabilities. since the - sars outbreak, the global health community has engaged in substantial efforts to be prepared to handle outbreaks such as the ongoing covid- outbreak. a milestone achievement is the international health regulations, a binding instrument of international law that entered into force on june intending to assist countries to work together to save lives and livelihoods endangered by the international spread of diseases. the regulations target the response to the international spread of disease as well as the core surveillance and response capacities of countries. additionally, they give certain powers to state parties (ie, closing ports, airports, and ground crossings) that governments cannot ordinarily exercise. yet, these powers must be exercised with caution, in accordance with their relevant national law and obligations under international law, including human rights law, and upon considering scientific principles, available scientific evidence of a risk to human health, and who' s guidance or advice [ ] . as habibi and colleagues point out, the intention of the regulations is that "countries should not take needless measures that harm people or that disincentivise countries from reporting new risks to international public health authorities" [ ] . yet, even when done correctly, in line with the scientific knowledge, and full respect of international human rights law, emergency handling and planning is not sufficient to manage the spread of infectious disease. to be effective, emergency handling and planning must be carried out in an environment in which new treatments -such as drugs and vaccines developed ad hoc to stop the outbreak -can be developed rapidly and delivered efficiently to all persons affected. this was not the case in the urban area of wuhan, which suffered from health care delivery problems at the time of the outbreak. in a matter of days, the local authorities conclude that the health care facilities were insufficient to handle the emergency and announced plans to build from scratch not one but two new hospitals. these construction projects were completed in just a few days and accommodate patients. similar problems are experienced by other nations as covid- spreads. this is extraordinary. but it should not be. strengthening the health care infrastructure should have been planned for a while. the failure to do so is a cautionary tale of insufficient efforts to protect global health. the global health community must thus push countries harder to keep strengthening their research capacity and basic health care infrastructure along with emergency handling and planning efforts. human rights play a key told in pushing countries hard. they are a powerful tool to act as they create legal obligations that go beyond the immediate and pressing needs of emergency preparedness and handling. international human rights law is critical as it transforms global health best practices in legal duties. the leading treaty in this area is the covenant on economic, social and cultural rights, which recognizes the right to health (art. ) and the right to science (art. ) [ ] . while the right to health is often invoked in the global health arena -although only to a limited extent in the context of global health preparedness -the links between right to science and global health have received very little attention (with some exceptions in the area of drug-resistant tb policies) [ ] . this provision imposes on state parties the duty to ensure that scientific knowledge is produced and translated into applications, such as drugs and vaccines, that are beneficial to rightsholders. for this, substantial public funds must be allocated on a regular basis to r&d. the covenant also includes the duty to ensure a sufficient degree of scientific literacy in the population so that, when vaccines become available, patients readily embrace new treatments. human rights advocacy in this area is about to become more effective due to the recent approval by the un committee on economic, social and cultural rights of a general comment on the relationship between science and economic, social and cultural rights [ ] . when the official version of the general comment is published (likely in april ), this instrument will provide a clear framework of state obligations under article of the covenant. in fact, the draft that was made public makes the case. it stresses that governments have "a positive duty to actively promote the advancement of science" and must fund basic and applied research (para. ). to this, it adopts the recommendation of the scientific advisory board of the united nations [ ] that "all countries, including the poorest, to invest at least % of their gdp on research and urged the most advanced countries to spend at least % of their gdp on research and development" (para. ). furthermore, it states that governments must approve "policies and regulations which foster scientific research, allocating appropriate resources in the budgets and, in general, creating an enabling and participatory environment for the conservation, development and diffusion of science and technology" (para. ). the general comment on science and economic, social and cultural rights is an important addition to the human rights that are traditionally invoked in the global health arena. most importantly, it reinforces the power of human rights law to frame the global health discourse not only in terms of public health necessity to act but also in terms of a legal duty to act. the global health community should not forget that ensuring good science and the attainment of the highest level of health are human rights and an indispensable dimension of global health policy. only when cultivated and guaranteed as a human right, science provides the support needed to fight global health emergencies. photo: image by miroslava chrienova from pixabay. strengthening their research capacity and basic health care infrastructure must be incorporated in epidemic preparedness. human rights law provides the necessary legal support to hold countries accountable for these efforts. authorship contributions: ab is the sole author. the author has completed the icmje form (available upon request from the corresponding author), and declares no conflict of interest. world health organization. urgent health challenges for the next decade geneva: world health organization do not violate the international health regulations during the covid- outbreak funding for tuberculosis research-an urgent crisis of political will, human rights, and global solidarity scientific advisory board of the united nations secretary-general. the future of scientific advice to the united nations, a summary report to the secretary-general of the united nations from the scientific advisory board. unesco key: cord- - kf mgy authors: sklar, david p. title: covid- : lessons from the disaster that can improve health professions education date: - - journal: acad med doi: . /acm. sha: doc_id: cord_uid: kf mgy covid- has disrupted every aspect of the u.s. health care and health professions education systems, creating anxiety, suffering, and chaos and exposing many of the flaws in the nation’s public health, medical education, and political systems. the pandemic has starkly revealed the need for a better public health infrastructure and a health system with incentives for population health and prevention of disease as well as outstanding personalized curative health. it has also provided opportunities for innovations in health care and has inspired courageous actions of residents, who have responded to the needs of their patients despite risk to themselves. in this invited commentary, the author shares lessons he learned from earlier disasters and discusses needed changes in medical education, health care, and health policy that the covid- pandemic has revealed. he encourages health professions educators to use the experiences of this pandemic to reexamine the current curricular emphasis on the bioscientific model of health and to broaden the educational approach to incorporate the behavioral, social, and environmental factors that influence health. surveillance for disease, investment in disease and injury prevention, and disaster planning should be basic elements of health professions education. incorporating innovations such as telemedicine, used under duress during the pandemic, could alter educational and clinical approaches to create something better for students, residents, and patients. he explains that journals such as academic medicine can provide rapid, curated, expert advice that can be an important counterweight to the misinformation that circulates during disasters. such journals can also inform their readers about new training in skills needed to mitigate the ongoing effects of the disaster and prepare the workforce for future disasters. as i was planning the transition from my role as editor-in-chief of academic medicine on january , , little did i know that covid- would explode onto our health care, clinical research, and education systems. i imagined the journal would continue its focus on topics such as competency-based education, professionalism, workforce diversity wellness, new technologies for education, and other innovations in health professions education. i did not imagine former residents writing to me a few months later about the overwhelming numbers of patients on ventilators who were dying of a disease the residents had never seen before, one that was being described on a daily basis in journals around the world. i did not imagine all of our educational conferences becoming online sessions because having students and faculty sit together in a room now posed too great a risk of infection. covid- has disrupted every aspect of our health care and education systems, creating anxiety, suffering, and chaos for our society and exposing many of the flaws in our public health, medical education, and political systems. in this invited commentary, i describe some characteristics of earlier disasters, discuss some of the changes in medical education and health care that the covid- pandemic has starkly revealed are needed, and explain what academic medicine can offer in such a confusing time, when unexpected events have thrown our plans off course, replacing them with new crises that demand our attention on a daily basis while every media outlet is competing for the newest health information. years ago, i found myself in unexpected dire situations that, like the covid- pandemic, could be classified as disasters, and i thought i might share of them. the first time was in in guatemala as part of a disaster relief team after an earthquake. we experienced numerous terrifying aftershocks, and i worried that i might get crushed under a collapsing building. i often wondered what good we were doing amid all the destruction, but i came to realize that by being there day after day, not giving up, helping injured people one at a time, and putting what we could back together we were slowly creating the foundation of the new town and the new hospital that would eventually replace what had been destroyed. i visited the town years later and there was barely a trace of the earthquake or any memory of the trauma among the people i met. the next time was in san francisco at the beginning of the aids epidemic when i was a resident. young gay men began to fill the wards with diseases that none of us had seen before; many of them were my age. some invisible demon had entered their bodies, consuming them from the inside and outside at the same time. i would read the reports of increasing numbers of cases of a rare pneumonia and of what we would soon come to call aids in the morbidity and mortality weekly. the incessant rise in cases and deaths was terrifying, like the daily toll of covid- deaths that flash on today's television and computer screens. i felt helpless, confused, and scared. as faculty and residents, we could not imagine that a new infectious disease could just appear that had not abstract covid- has disrupted every aspect of the u.s. health care and health professions education systems, creating anxiety, suffering, and chaos and exposing many of the flaws in the nation's public health, medical education, and political systems. the pandemic has starkly revealed the need for a better public health infrastructure and a health system with incentives for population health and prevention of disease as well as outstanding personalized curative health. it has also provided opportunities for innovations in health care and has inspired courageous actions of residents, who have responded to the needs of their patients despite risk to themselves. in this invited commentary, the author shares lessons he learned from earlier disasters and discusses needed changes in medical education, health care, and health policy that the covid- pandemic has revealed. he encourages health professions educators to use the experiences of this pandemic to reexamine the current curricular emphasis on the bioscientific model of health and to broaden the educational approach to incorporate the behavioral, social, and environmental factors that influence health. surveillance for disease, investment in disease and injury prevention, and disaster planning should be basic elements of health professions education. incorporating innovations such as telemedicine, used under duress during the pandemic, could alter educational and clinical approaches to create something better for students, residents, and patients. he explains that journals such as academic medicine can provide rapid, curated, expert advice that can be an important counterweight to the misinformation that circulates during disasters. such journals can also inform their readers about new training in skills needed to mitigate the ongoing effects of the disaster and prepare the workforce for future disasters. existed before, and we initially thought the disease must be from a toxin of some kind, perhaps a drug that poisoned the immune system. when we learned that it truly was something new, the effects of a virus on the immune system that had not been seen before in humans, it was a shock and a revelation that our medical education had not prepared us for this. it made me wonder about other gaps in my medical education, such as the role of public health in the prevention and spread of this new disease. the third time was about years later in new mexico when several of my patients began appearing from the four corners region with respiratory failure and pulmonary infiltrates. they were mostly navajos who had been previously healthy. most died rapidly, and i thought that by the time anyone figured out the cause of the illness i would also die, carried off by the same unknown infection. fortunately, the hantavirus that caused the illness did not spread between humans, but if it had been like the covid- virus, i probably would have caught it because the masks and gowns we had at the time were not very effective or used consistently. my colleagues and i wrote about the hantavirus epidemic as an example of an infectious disease disaster and made recommendations about how to address infectious disease disasters in the future. at the time, we imagined a limited infectious outbreak and never conceived of anything as widespread as covid- . it was not until several years later after the attacks of september , , that fears of a biological terrorist attack led to the funding of comprehensive training for infectious disease disasters and the development of what we now call personal protective equipment (ppe). the money and enthusiasm for such preparation soon dried up, however, as it became clear that planning for a serious but unlikely event required a continued investment that could not be justified in a world where annual return on investment was the operative principle. if there was no disaster for several years, the return on investment for training and stockpiling of ppe would be negligible. through those experiences with catastrophes, i learned that fear and uncertainty are widespread during a disaster, information changes constantly and is often inaccurate, experts whom we depend upon often turn out to not really have any expertise in the particular disaster situation, and leaders can emerge from unlikely, unexpected places, often by chance rather than by design. journals such as academic medicine can provide curated, expert advice based on previous literature that can be an important counterweight to the circulating misinformation. they can also publish new information online quickly, as academic medicine has been doing, and can inform their readers about new training in the skills that will be needed to mitigate the ongoing effects of the disaster and prepare the workforce for new disasters. i have previously written about the potential role of academic health centers (ahcs) in relation to disasters in this journal and described the importance of having expertise in disaster preparedness, research, education, and response that could be located at ahcs. unfortunately, disaster preparedness has not been a high priority at most ahcs, leaving them woefully underprepared for the covid- disaster. something i noticed from previous disasters was that the victims were not distributed equally in the population. it was often the most vulnerable-for example, those who required chronic care like dialysis, or medications for diseases like diabetes whose care became disrupted-who suffered the most. people who were poor, homeless, mentally ill, or chronically debilitated often did not have the capacity to resist a new infection or an injury associated with a disaster. to address this problem, disaster teams needed to seek out members of vulnerable populations rather than expecting them to find their way to the care system, because many of them did not have the resources to seek care. unfortunately, we are finding a similar pattern now with covid- in the united states, with a disproportionate share of victims coming from minority, poor, and chronically ill populations. finally, i noticed that disasters can bring out the best in people. i encountered many individuals who were truly heroic. they were not persons who would normally stand out, but when they were thrust into critical situations, they would sacrifice their own safety to help others who were often strangers. i would put our current residents in that category. i am so proud of them for their courage and perseverance day after day to care for patients whose disease could be passed on to them and their families and could lead to their own illness or even death. if there is any silver lining to all the devastation that we have witnessed, it is the example set by our younger generation of residents and faculty, who have shouldered much of the weight of caring for patients with this terrible disease. i have had the opportunity to work side by side with some of our residents and believe they could be the nidus of a movement to create a cultural change in our society that emphasizes service and sacrifice for others, which we need if we are to become a caring and compassionate healing community. when we ask our residents to risk their lives, all of us also need to share the responsibility for policy and education decisions that put their health at risk. their courageous acts might not have been necessary if we had done more to prevent the spread of the disease, so we need not only to applaud our residents' acts but also to take steps to not put them in that dangerous position again. our health professions education community should use what we have learned from the covid- pandemic to finally make the changes in our education system that promote the health of our trainees. ripp et al have described how a task force at mount sinai health system in new york city addressed the wellness needs of the health care workforce in response to the covid- pandemic; these included personal safety, food, childcare, transportation, sleep, communications, and psychological support. aren't these the same needs of our trainees throughout their education? i don't think we can continue the abusive work schedules that had little evidence of positive impact and were driving many of our students and residents to the breaking point even before covid- arrived. while disasters by their very nature overwhelm the normal health care resources, we were starting from a point of weakness with residents and students already burned out. i hope that one outcome of this covid- pandemic is that our academic medical centers and our educational community will stand up for our residents and make the changes in work hours and schedules that would promote residents' health and wellness. there are some other changes that our health professions education community should consider as we reflect upon the covid- pandemic. our emphasis on the bioscientific model of health has dominated our curricula and assessment systems in medical education since the flexner era, but our curricula now must also incorporate the behavioral, social, and environmental factors that influence health. surveillance for disease, investment in disease and injury prevention, and disaster planning should be basic elements of health professions education. this is not to denigrate the remarkable advances in our understanding of personalized health care that have come as a result of scientific discovery, but rather to recognize the importance of an ecological framework for human health that wraps the individual and his or her story within the context of the community and environment in which that person lives. while the bioscientific model may produce clinician scientists who will ultimately create a vaccine for covid- , it will not produce the workforce that will prevent the next pandemic or provide the health system that will be able to respond effectively to it. finally, many of the sacred cows of medical education have been thrown into question during the covid- pandemic, from in-person attendance at lectures, to proctored standardized content tests for recertification of practicing clinicians, to the structure of medical student clinical clerkships. telemedicine has been recognized as a frequently effective alternative to in-person ambulatory visits. there is an opportunity to use what we have learned under duress to alter our current educational and clinical approaches to something better for students, residents, and patients. we appear to be able to improve quality of care, reduce cost, and improve health professionals' safety in some telemedicine innovations. therefore, we should be able to integrate these innovations into our education programs. i believe that as terrible as covid- has been for our country and the world, it has pried our eyes open to the need for a better public health infrastructure and a health system with incentives for population health and prevention of disease as well as outstanding personalized curative health. both approaches in health care are possible and necessary. i hope we have learned that we cannot build walls that will keep us secure from all the dangers of the world. just as weather patterns do not respect the borders between countries, neither do diseases. while our languages and cultures differ, all of us on this planet want our families, communities, and our selves to flourish and succeed. we can learn from each other despite our differences. we all gain with vaccines for disease, information about climate change, adequate food, and clean water and air. poverty and disease in one country are problems for all of us, and border fences will not prevent their spread. as we move toward an election in the united states, it is important that our voices are loud about what we have experienced and learned. if the people of the world truly believe that our health professionals are heroes, we may have a unique opportunity to influence the political leaders of the world about the best path forward to improve the health of the world and every country in it. i look forward to academic medicine helping us to develop our messages in its pages over the coming months. funding/support: none reported. presenting characteristics, comorbidities, and outcomes among , patients hospitalized with covid- in the new york city area innovation in response to the covid- pandemic crisis earthquake in guatemala: epidemiologic evaluation of the relief effort emergency department response to a disaster from an emerging pathogen responding to disasters: academic medical centers' responsibilities and opportunities attending to the emotional well-being of the health care workforce in a new york city health system during the covid- pandemic other disclosures: none reported.ethical approval: reported as not applicable. key: cord- -s nhzdm authors: nanjundaswamy, madhuri h.; pathak, harsh; chaturvedi, santosh k. title: perceived stress and anxiety during covid- among psychiatry trainees date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: s nhzdm nan dear editor, covid- has induced fear and panic among everyone especially in older adults, health care providers and people with underlying health conditions. medical professionals are more susceptible to be infected. this widespread outbreak is also associated with adverse mental health issues like anxiety, depressive symptoms, obsessive-compulsive disorder and posttraumatic stress disorder (shuja et al., ) . the current survey aimed to evaluate subjective mental health status, stress and anxiety related to covid- . an online survey was conducted among the consenting junior and senior psychiatry resident doctors in a tertiary care post graduate mental health institute in south india. the survey focussed on worries related to covid- infection, psychosocial impact of lockdown and their mental health status in the preceding - weeks, what coping strategies residents had developed to deal with the situation and how much support was perceived to be received by the residents. the questionnaire was sent through the online portal to all residents, followed by two reminders. the anonymity of responses was maintained. out of , ( %) residents completed the questionnaire on stress and anxiety during covid- pandemic. table highlights some of the common worries related to covid- pandemic. healthcare workers are at significant risk of adverse mental health outcomes due to long working hours, risk of infection, shortages of protective equipment, loneliness, physical fatigue, and separation from families (pfefferbaum and north, ) . medical workers face discrimination, stigma and isolation as reported in chinese and pakistan medical workers (zhai and du, ) . in our survey, ( %) residents were afraid to go home after work and ( %) reported fear of stigma or discrimination in their neighbourhood. also, the impact of lockdown was reported to some extent by ( %) and to great extent by ( %), with some common themes of anxiety, apprehension, loneliness, sadness, uncertainty, sadness leading to frustration and irritability. majority of the residents ( %) perceived their mental health either same or even better than before in the last - weeks; another one-third reported j o u r n a l p r e -p r o o f it to be worse than before. mental health is a crucial aspect during lockdown which may have varied presentation such as anxiety, depression, loneliness, panic, financial constraints, apprehension about future which was noticed among a majority of residents in our survey also (hiremath et al., ) . the steps taken by the institute in handling the mental health issues were found to be helpful by % of the residents. also, various coping strategies were employed by the residents to address their concerns were following a daily routine, indulging in indoor hobbies, yoga, meditation, physical exercises, increased virtual interaction with friends and family, talking to peers, seniors, as well as supervisors and few, practised mindfulness. some of them used distraction techniques like watching tv series, reading novels, cooking, painting, music etc. a recent study on medical and nursing staff showed, % and % had mild mental and moderate mental health disturbances respectively during the immediate period of the epidemic. among them % had accessed psychological resources materials like books, % had accessed online psychological resources as coping strategies and % underwent counselling (kang et al., ) . the current pandemic has posed a huge challenge on the health care staff who were unprepared. moral injury has been described in medical students, who have difficulty coping with working in prehospital and emergency care when they were exposed to trauma for which they were unprepared (greenberg et al., ; murray et al., ) . this might be similar to the current situation which we are facing. considering the unprecedented nature of the problem health care workers need adequate support to work efficiently. the routine services provided to persons with mental health problems have been withdrawn during the lockdown, giving rise to potential aggravation of their mental health status. this is yet another challenge for trainees (chaturvedi, ) . hence, early support includes preparing the staff for the job and associated challenges and by providing straight forward assessment of what they might face. also, as the situation progresses team leaders should help staff to discuss decisions and well-being using the schwarz rounds model. this is a forum for healthcare staff to safely discuss the emotional and social challenges of caring for patients led by the team leaders. during the aftercare i.e., once the crisis is over, supervisors should ensure to reflect upon and learn from the difficult experiences to create a meaningful rather than distressing experiences (flanagan et al., ; greenberg et al., ) . there is definitely a need for the reduction of stress and psychological distress among health professionals. the important measures are normalization of strong emotions and stress, the fulfilment of basic needs, social support, clear communication and distribution of tasks, flexible j o u r n a l p r e -p r o o f working hours and the utilization of psychosocial and psychological help without stigmatization (petzold et al., ) . screening for mental health problems, psychoeducation, and psychosocial support will help in the prevention of serious mental health issues among the psychiatry trainees. the authors declare that they have no known compe ng financial interests or personal rela onships that could have appeared to influence the work reported in this paper. nil. none of the authors have any conflict of interest. covid- , coronavirus and mental health rehabilitation at times of crisis reflection for all healthcare staff: a national evaluation of schwartz rounds managing mental health challenges faced by healthcare workers during covid- pandemic covid : impact of lock-down on mental health and tips to overcome impact on mental health and perceptions of psychological care among medical and nursing staff in wuhan during the novel coronavirus disease outbreak: a cross-sectional study are medical students in prehospital care at risk of moral injury? dealing with psychological distress by healthcare professionals during the covid- pandemia mental health and the covid- pandemic covid- pandemic and impending global mental health implications mental health care for international chinese students affected by the covid- outbreak. the lancet psychiatry none. key: cord- -tjxt vd authors: jackson-morris, angela; nugent, rachel title: tailored support for national ncd policy and programme implementation: an over-looked priority date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: tjxt vd many low-income and middle-income countries (lmics) are unlikely to achieve sustainable development goal . to reduce premature deaths from non-communicable diseases (ncds) by one-third by . for some, the prospect is receding: between and , the decline in premature deaths for the major ncds slowed compared with the prior decade. barriers to implementing effective strategies are well known, yet the value of tailored technical support to countries has been overlooked and downplayed. tailored technical support is specialist guidance for country-specific application of technical tools, and capacity enhancement when needed, that enables an lmic to advance its ncd priorities and plans. we present a model identifying pivotal junctures where tailored technical support can help surmount implementation obstacles. we draw on our experience preparing ncd investment cases with health ministries, development partners and technical agencies. national investment cases produce evidence based, locally tailored and costed packages of ncd interventions and policies appropriate to national needs and circumstances. they can include analysis of financing needs and point towards sustainable funding mechanisms. enhancing the ncd-specific knowledge of government and civil society organization leads can capitalise on existing expertise, aid integrative health system developments and unlock capabilities to use global tools and guidance. investment cases form a platform to develop or review ncd plans and (re)prioritise action, then apply implementation science to trouble-shoot obstacles. partnering national stakeholders with technical support in this process is critical to develop and implement effective ncd strategies. low-income and middle-income countries (lmics) experience many barriers in carrying out their non-communicable diseases (ncds) strategies. this is evident in the deceleration that has occurred in reducing premature mortality from major ncds since and is painfully manifest in the conclusions of the latest who national country capacity survey. this survey found that generally integrated ncd policies were of inadequate breadth, 'best buy' interventions vastly underused, ncd surveillance systems insufficiently robust, lack of clinical guidelines for leading ncds, cancer-screening programme reach was often inadequate, essential ncd technologies and medicines remained widely unavailable, and palliative care was sparse. these weaknesses predated the covid- pandemic, however, severe acute respiratory syndrome coronavirus (sars-cov- ) brutally exposed the limitations of many countries' health systems as well as the significant vulnerability of the large numbers of people living with ncds that insufficient action has created. key barriers to ncd strategy implementation have been well articulated in the last decade. the who independent high-level commission on ncds highlights the need for political support to advance the ncd agenda, and need to develop sustainable financing for programmes, service delivery and human resources. in a brief sentence in this report, some commissioners highlighted the need for more tailored support to lmic to implement ncd strategies. we contend that tailored technical support is actually pivotal to enable summary box ► barriers to implementing effective noncommunicable disease (ncd) strategies are well known, yet the value of tailored technical support to countries has been overlooked and downplayed. ► we present a model of steps focused at key ncd implementation junctures that often require tailored technical support to ensure progress. ► national investment cases provide countries with evidence based, locally tailored and costed packages of ncd interventions and policies appropriate to national needs and circumstances. ► tailored technical support can empower national stakeholders to put investment cases into operation by partnering local expertise with specialist guidance for specific policies and programmes, using implementation science to surmount implementation obstacles and building national ncd capacity. the report's more prominent recommendations to be put into practice, and provision of such support requires serious consideration-and urgently-if we are collectively to move closer to achieving sustainable development goal (sdg) . in years time. the terms 'technical support'/'technical assistance' are widely used in health and development although definitions and emphases vary. common features are external provision of specialist knowledge, partnership with local stakeholders and capacity-building. tailored technical support is meant here as provision of specialist guidance to support country-specific application of technical tools, and capacity enhancement when needed, to enable an lmic to advance its ncd priorities. drawing on our experience preparing ncd investment cases and designing ncd strategies and implementation by partnering with health ministries in multiple countries, we present a model to suggest how national ncd implementation may be strengthened. the model (figure ) identifies a series of critical components that precede effective implementation: working with national stakeholders to select the most effective and cost-effective policy and programme priorities for a specific national context; identifying how to fund these sustainably; ensuring the system has capacity to lead and deliver the priorities; reviewing/renewing national strategy to reflect the chosen priorities; and creating a costed, actionable implementation plan. we propose that providing tailored technical support at these critical junctures when needed, working in partnership with national stakeholders, can galvanise ncd implementation. the components may be viewed as steps that can be applied sequentially or the model can identify the missing components in a specific context where some are already in place. thus, a country may use an investment case to review and reprioritise an existing strategy; some countries may have stronger ncd stakeholder capacity and may not need to address this; some may have sustainable funding mechanisms under development yet can beneficially align these to the newly identified priority interventions and revised strategy. in this way the model may be flexibly used, recognising that lmics are at different starting points and relating to their particular circumstances and contexts. for many countries, an investment case is the starting point. an investment case uses economic and political analysis to provide countries with an evidence-based agenda for implementing ncd policies that provide best valuefor-money and is feasible in that country. the process of conducting an investment case has been described elsewhere and involves careful review of existing ncd programmes and policies, discussions with national stakeholders to determine how to augment existing programmes in scale and scope, costing these and calculating return on investment-for population health and the national economy. each step entails detailed discussions with the ministry of health and, importantly, the other ministries that have a stake in the results in relation to the economy, agriculture, industry and education. civil society and private stakeholders are also engaged, collectively providing an understanding on how to align interests and take forward the priority actions. this inclusive process is a key for establishing credibility and laying the groundwork for policy and delivery to evolve. the impact of individual investment cases varies from country to country and can be hard to measure and harder to attribute. testimonials from policy-makers who have commissioned and used investment cases, as well as the large backlog of country requests for investment figure pivotal points for tailored technical support to support ncd implementation. ncd, non-communicable disease. bmj global health cases, lends authenticity to their value. notably, many country requests for investment case support have been made but are yet unfunded. while not every investment case results in immediate or attributable impact, a growing set of examples shows that investment cases can be game-changing to obtain political 'buy-in' and can catalyse multisectoral dialogue on funding solutions. the evidence from these experiences is that investment cases can catalyse a cascade of national actions such as expanding existing service coverage or implementing new prevention policies. the republic of georgia demonstrates how a well-timed investment case can unblock policy action. in , the health ministry was able to introduce the results of a pilot tobacco control investment case into debate over stalled tobacco control legislation. after the investment case was presented the georgian parliament agreed on multiple policy changes to reduce tobacco use in the country. similarly, investment case results were cited in the tobacco control legislation presented to the armenian parliament. other times the results do not lead directly to legislation but generate interest from advocacy groups and ministries of finance and advances dialogue about the implementation gaps. an example of such awarenessraising comes from the samoan tobacco control investment case. during the cabinet briefing on the investment case findings, the prime minister directed the minister of finance to immediately raise tobacco taxes. in kenya, a recently completed ncd investment case drew attention to the high price tag of increasing ncd treatment coverage. as for many countries, action on their investment case recommendations now awaits an accompanying funding strategy. an investment case coalesces stakeholders, creates a sense of urgency and fosters 'buy in', and identifies clear investment priorities. these are prerequisites to achieving sustainable funding for ncd strategy implementationwhether from the ministry of finance or external sources. an investment case quantifies the health and economic benefits of implementing ncd prevention and control, yet those results are theoretical without a financing plan to show policymakers and development partners how the strategies can be realised. the financing plan assesses the prospects for generating additional funding from the domestic budget, whether through revenue growth such as higher taxes or resource reallocation, and possible innovative financing sources, such as development bonds or social investment partnerships. the choice of financing mechanisms may be constrained for many low-resource countries and must be determined by responsible national financial officials in line with their development strategies. but once the ncd investment case is in hand, priority interventions are agreed, and financing is assured, how is effective implementation achieved? the who global coordinating mechanism working group on financing for ncds developed a tool to assist countries to assess options, yet national capacity to employ this may be stymied without specialist guidance. unexpected knowledge gaps can become major impediments if data and skills are unavailable in-country. such gaps commonly emerge around data analysis, programme costing, budgeting, fiscal and legal policy formulation, demand forecasting, procurement of medical supplies and resource mobilisation. these policy and programme development components require specialised technical skills and can be provided through tailored technical support alongside capacity development so functions can be sustained as programmes mature. figure shows the linked foundations of effective ncd policy and programme implementation: evidence-based priority setting, strengthening ncd-specific understanding among stakeholders, and ensuring recommended actions can be funded. each step may require targeted technical support. for example, a investment case developed by the jamaican government with support from the united nations development program (undp) examined the return on investment from scaling up ncd clinical interventions and implementing or intensifying prevention policies. the results showed a potential saving of us$ million and lives in jamaica between and from implementing the intervention package. this analysis spurred an immediate response from the government's top echelons to implement the ncd programme to accelerate their ambitious economic growth targets. the experience highlighted specific knowledge and skill gaps that had hitherto hindered the health ministry from achieving high level policy attention, despite having an ncd strategy and strong inter-governmental apparatus. gaps had included lack of costing for ncd programme components, need for greater interministry coordination (promptly acted on following the investment case), and greater awareness of the contribution that improved health would make to economic goals. until the current pandemic, the links between communicable and ncds had been overlooked by many global and national health officials, and there is now urgency to determine how to protect people with ncds and to create stronger population resilience. investment cases can assist governments by identifying synergies between addressing chronic disease and pandemic resilience, such as health system strengthening measures to ensure services to treat and manage ncds functioning during pandemics, averting excess ncd mortality and acute admissions. this evidence can then be used to identify sustainable financing mechanisms. global guidelines, protocols and tool-kits offer highquality support to national ncd planning. yet it is a leap of faith to envisage that managers can take these 'off bmj global health the shelf' and apply them, even when there is high-level 'buy-in' to address ncds, or that civil society organisations can identify how they can contribute. this is evident from the increased number of ncd plans that sit in place alongside a low level of health system readiness to deliver policies, programmes and services. ironically, given the scarcity of ncd funding, bottlenecks are created whereby available ncd funds remain unspent. growth in the number of ncd-trained national health and policy professionals is encouraging. some mics offer ncd specialist training in academic and workforce curricula. yet an ncd skill deficit is common and ncd departments are often still small and pulled in many directions. the current paradigm must shift from: 'i'm a [hiv/maternal health person] and new to ncds', to each lmic having a cadre of national officers confident in their ncd expertise. adding this to their experience in the existing (dominant) priorities, such as communicable disease, maternal and reproductive health, will be a major step towards health system integration solutions. empowering civil society as partners in the ncd agenda is a vital complement to this. strengthening national ncd capacity is a mediumterm goal. just as with the hiv/aids pandemic and covid- , there is a critical need to support countries while health crises are underway. national stakeholders (government, civil society and private sector) collectively possess the strongest understanding of their context, a wealth of data and crucially-staff, policy-makers and politicians to lead action. even where national ncd capacity is stronger, provision of technical support on the policy, system and programmatic mechanisms that can address specific conditions and risk factors can enhance and accelerate progress and reduce health and economic losses. much has been and can further be learnt from earlier experience in collectively advancing global and national health. best results come when national stakeholders are 'in the driver's seat' with tailored technical support on board as mechanic/navigator, providing specific assistance to facilitate an effective journey. both national stakeholders and external technical experts are needed. for example, it has been useful to partner government economists and lawyers with global counterparts who specialise in specific risk factors or conditions to develop fiscal and regulatory measures that are resistant to challenges from global commercial and industrial interests. such collaborations have been notable in tobacco control, partly owing to the complex, globalised legal, fiscal and commercial influences on the issue at national level, but also because funders recognised unmet need among national governments and prioritised technical assistance and national capacity building. global specialists can also introduce new techniques or technologies to build national capacity to apply these to ncds. figure provides an example of this synergistic partnership in relation to ncd policies and programmes developed by the st helena government in - . escalating ncd prevalence and cost of treating ncds on the island and evacuating emergency and complex patients for care overseas generated the political will to reorient bilateral funding towards ncds. significant value was added by partnerships that married local contextual expertise with solid evidence from other sources and highly specific support to co-produce solutions to what would otherwise be implementation challenges. this illustrates the 'design and delivery of specific ncd priority strategies' and 'health system strengthening for implementation and integration' components of figure the model we have put forth to move from investment cases and sustainable financing development to ncd strategy development/review and implementation planning can be informed by using an implementation science framework. implementation science addresses the need to develop, test, evaluate and retest the interventions and processes that constitute an ncd programme. knowledge will emerge about 'what works' and should be shared widely to aid effective delivery. there are various implementation science models, with the shared aim of improving knowledge in context to support effective implementation. the consolidated framework on implementation research (cfir) identified five key aspects of implementation that influence intervention outcomes. these relate to characteristics of the intervention itself, factors related to the context ('outer setting'), the implementers ('inner setting', including the partnership between national stakeholders and technical support providers), and the implementation process. specific constructs within these can be systematically analysed to identify barriers and facilitators for successful implementation, and these may then be translated into questions that can be answered through research and used to refine plans, programmes, and policies to better address needs, gaps or inequalities. thus, an investment case may identify a specific intervention as a cost-effective priority based on national data; implementation research can then indicate how this may impact population groups differently and suggest ways bmj global health that the implementation process and supporting actions should be tailored. for illustration, the better health programme (bhp) is a collaborative technical support programme supported by the uk foreign commonwealth office. bhp is applying implementation science to identify which of the obesity prevention strategies identified elsewhere as successful will be effective and acceptable in kuala lumpur's poorest communities. 'discrete choice experiments', 'knowledge, attitude and practices' surveys, interviews and focus groups are being used to elicit stakeholder needs, preferences and constraints to inform design, delivery and modification of interventions on how to enable healthier food and drink consumption and increase physical activity. support to apply an implementation science lens to ncd plans can in the short-term bridge the divide between plans and implementation, employ available evidence in a contextrelevant manner, and in the medium-term build national capacity to apply the techniques. the analysis presented in this paper: the need to put in place-specific components to strengthen national implementation of ncd strategies and programmes, and to provide tailored technical support to enable this, relates to two particular aspects that the cfir identified as influential on implementation outcomes. within the 'inner setting' (the national context for ncd implementation), the 'structural characteristics' of the lead organisation (government/ministry) includes its 'social architecture', age, maturity and size, and these characteristics can influence its ability to successfully implement policies and plans. within the 'outer setting' (external influences that can encourage a government to act to address ncds), 'cosmopolitanism' describes the degree that an organisation is networked with other external organisations. our contention is that the current status of underdevelopment of ncd capacity at national level (priority, funding, capacity) may combine with an absence of external technical support and thus create a cycle of poor implementation. while perhaps politically unfashionable to highlight direct support needs, we contend that at the present time technical support is essential to empower national health providers and policy-makers to operationalise effective ncd strategies. support is needed to develop three fundamental, interconnected building-blocks: investment cases, sustainable financing mechanisms and national ncd technical leadership; to employ implementation science to create actionable ncd solutions from national plans; and tailored guidance to maximise the impact of specific policies, programmes and system developments. in the complex world of global health organisations, there are various institutions, foundations and agencies that can provide components of the required support, depending on their technical capabilities in relation to specific issues, delivery capacity and infrastructure and relationships in different countries. serious progress on sdg . in lmics requires bilateral and multilateral donor organisations and philanthropic foundations to enable these implementation support partnerships. twitter angela jackson-morris @angiembjm and rachel nugent @rachelnugent contributors aj-m initiated the conceptual model. rn and aj-m refined and further developed this. aj-m and rn coproduced and revised the manuscript. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. competing interests none declared. patient consent for publication not required. provenance and peer review not commissioned; externally peer reviewed. data availability statement all data relevant to the study are included in the article or uploaded as supplementary information. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. angela jackson-morris http:// orcid. org/ - - - rachel nugent http:// orcid. org/ - - - world health statistics : monitoring health for the sustainable development goals assessing national capacity for the prevention and control of noncommunicable diseases: report of the global survey world health organisation. it's time to walk the talk the investment case as a mechanism for addressing the ncd burden: evaluating the ncd institutional context in jamaica, and the return on investment of select interventions investing in non-communicable disease prevention and management to advance the sustainable development goals investing in the prevention and control of non-communicable diseases for sustainable development: countries discussed the role of investment cases power dynamics, capacities and incentives that frame the implementation of ncd policies: lessons learned from conducting institutional and context analyses world health organisation. global ncd investment case encouraged the norwegian government's development of its ncd strategy and funding studying investment in tobacco control in low-and middle-income countries world health organization. launch of ncd investment case in armenia the cost of tobacco use on a nation. the samoa observer world bank group working paper: combating noncommunicable diseases in kenya: an investment case final report and recommendations from the working group on ways and means of encouraging member states and non-state actors to realize the commitment included in paragraph (d) of the political declaration of the high-level meeting of the united nations general assembly on the prevention and control of non-communicable diseases world health organisation. best buys and other recommended interventions for the prevention and control of noncommunicable diseases world health organisation. who steps surveillance manual. the who stepwise approach to non-communicable disease risk factor surveillance the relationships between democratic experience, adult health, and cause-specific mortality in countries between and : an observational analysis tobacco tax reforms to support economic development in west africa bloo mber gphi lant hrop ies t obac coreport. pdf national institute for health -fogarty international center fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science asking the right question: implementation research to accelerate national noncommunicable disease responses global better health programme key: cord- - ie c f authors: heimer, carol a. title: the uses of disorder in negotiated information orders: information leveraging and changing norms in global public health governance date: - - journal: br j sociol doi: . / - . sha: doc_id: cord_uid: ie c f the sars epidemic that broke out in late in china’s guangdong province highlighted the difficulties of reliance on state‐provided information when states have incentives to conceal discrediting information about public health threats. using sars and the international health regulations (ihr) as a starting point, this article examines negotiated information orders in global public health governance and the irregularities in the supply of data that underlie them. negotiated information orders within and among the organizations in a field (here, e.g., the world health organization, member states, government agencies, and international non‐governmental organizations) spell out relationships among different categories of knowledge and non‐knowledge – what is known, acknowledged to be known, and available for use in decision making versus what might be known but cannot be acknowledged or officially used. through information leveraging, technically sufficient information then becomes socially sufficient information. thus it is especially information initially categorized as non‐knowledge – including suppressed data, rumour, unverified evidence, and unofficial information – that creates pressure for the renegotiation of information orders. the argument and evidence of the article also address broader issues about how international law and global norms are realigned, how global norms change, and how social groups manage risk. to mean well-defined ignorance (gross and mcgoey : ) or a type of knowledge about the unknown (gross : ) . to be sure, influential research has considered such important matters as the distinctions between levels and kinds of ignorance, uncertainty, and risk, strategies for handling asymmetric information, and procedures for coping with dishonesty and duplicity (see, e.g., ackerlof ; arrow ; cook ; ericson and doyle ; goffman ; granovetter ; heimer b; knight knight [ ; shapiro ; williamson ) . what is missing, though, is a thorough incorporation of various forms of ignorance, such as non-knowledge, into existing theories of how people, groups, and organizations seek, assign meaning to, and use information (gross and mcgoey ; heimer ; mcgoey ) . researchers need to consider how exactly non-knowledge fits into the negotiated information orders that anchor organizational and interorganizational action. using sars as an example, this article examines negotiated information orders in global public health governance and the irregularities in the supply of the data that underlie them. information may be in short supply because it is suppressed, and it may also be of uncertain quality because it is incomplete or purposefully misleading. in effect, the sars case suggests, whether information is acquired from legitimate sources shapes not only the nature and quality of the information itself but also the uses to which it can be put. in addition to seeking information, then, actors strategically seek information from particular sources and deploy the information they have in hand to pressure others to augment or confirm existing information. through information leveraging, technically sufficient information becomes socially sufficient information. in this way, the article shows what a negotiated information order might look like when we more fully incorporate the social uses of non-knowledge and other forms of ignorance into our analysis. in particular, the article suggests that it is especially information categorized initially as non-knowledge -including suppressed data, rumour, unverified evidence, and unofficial information -that creates pressure for the renegotiation of information orders. although it is a truism that information is needed before rational decisions can be made, the importance of information for organizational decision making is often overestimated. since the pioneering work of herbert simon (march and simon ; simon ) , organization theorists have understood that the model of rational decision making was a poor description of reality and did not capture how information is actually used by organizations. because of limited cognitive and computational capacities, theorists suggest, organizations are only boundedly rational, accepting satisfactory solutions rather than continuing decision-making processes until they find optimal ones. besides using less information than might be expected, organizations also use it on a different timetable and for different purposes. for instance, information intensive solutions often are produced somewhat independently of the problems with which they are eventually matched (feldman ) . employing the metaphor of a garbage can, other scholars suggest that organizational decision making is not linear, but instead depends on how the semi-autonomous streams of choice points, problems, solutions, and participants come together (cohen et al. ; heimer and stinchcombe ) . moreover, information has symbolic as well as instrumental uses, often serving to legitimate decisions even when it plays little role in identifying problems and selecting or crafting solutions (feldman and march ) . decision making is a quintessentially social matter. decisions may depend less on whether decision makers have enough high-quality information than on whether they agree that the available information meets a variety of normatively or even legally established criteria. that is, whether or not information is technically sufficient, it must also be socially sufficient to be usable in decision making (heimer a) . information is technically sufficient if it can be used to answer key questions confronting an organization and if it can be used, perhaps with some modification, in an organization's decision-making algorithms. if decision makers cannot cite data of the sort conventionally used or recognized by their organizational field as sufficient for decision making, their decisions may be subject to challenge. a negotiated information order emerges when consensus is reached within or between organizations in a field regarding the criteria for socially sufficient information -about the type of information usable in decision making, the priority given to different types of information, and allocation of responsibility for gathering and interpreting that information (heimer a: ) . as these conceptual distinctions suggest, the symbolic nature of information penetrates even more deeply into organizational decision making than previous research might lead us to expect (feldman and march ; meyer and rowan ) . in particular, such symbolic considerations shape assessments of both decision-making processes and the information on which they are based. to work its symbolic magic, information must be seen as legitimate, and organizational actors will spar over whose data passes that test. but, crucially, such tests are layered. socially sufficient information is thus information that is widely agreed to be adequate to its intended purposes. technically sufficient information is more contested, with some actors touting its virtues and others casting doubt. technical sufficiency can therefore be a way-station along the path to social sufficiency or an intermediate category that permits some uses of information while prohibiting others. although participants experience these discussions as realist, social scientists would be quick to point out the deeply constructionist character of claims about the quality and veracity of information. the lines dividing categories of information are necessarily fluid, with discoveries shoring up some claims while undermining others and regularly adding to the stores of both knowledge and ignorance. as we will see, it is especially the boundary between knowledge and non-knowledge where contests are focused, because crossing that boundary makes otherwise prohibited actions possible. transposed into an organizational register, the dividing line between knowledge and non-knowledge takes the form of a distinction between technically and socially sufficient information. to say that the acceptability of information depends on a negotiated information order says only that the meaning of information is not given a priori but must be worked out collectively. norms about the sufficiency of information may be grounded in rules or laws. or they may reflect a broad, but informal consensus. what consensus is ultimately reached will depend on such factors as power differences, inter-organizational dependencies, and pre-existing loyalties. the preferences of powerful actors who have a vested interest in perpetuating practices associated with traditional types of information may have an outsized influence on the norms that emerge. previous agreements about the acceptability of various kinds and quantities of information provide important starting points, but will be less influential when decision makers face situations that seem unprecedented. thus negotiated information orders can be destabilized by modifications in technology, by the arrival of new problems or opportunities, or by changes in relationships among parties. three examples illustrate the importance of negotiated information orders in assigning meaning and determining how information is interpreted and used. clarke's mission improbable ( ) shows how information orders negotiated by powerful actors can exclude other voices that might challenge the meaning assigned to information. analysing organizations' plans to avert, control or cope with disasters, clarke considered the 'fantasy plans' created to clean up oil spills in open waters, evacuate long island in the event of a nuclear power plant accident, and protect the population during and after a nuclear war. in each case, rather than frankly acknowledging the impossibility of averting, controlling or mitigating disaster, key actors developed elaborate analogies and conducted careful simulations to convince themselves and others of the truth of essentially untenable propositions. the problem, of course, is that such analogies and simulations rarely worknuclear meltdown is not much like an ice storm, a major oil spill in open waters cannot be simulated by scooping up oranges from calm seas, and the evacuation of long island because of a nuclear accident cannot in good conscience be equated with the flow of people during rush hour. but when discussion is confined to a circle of experts, others may be unable to point out the obvious. here, the negotiated information order precluded consideration of information that other parties could have introduced by dismissing suppressed perspectives as unusable non-knowledge. with sars, as we will see, the first impulse of health workers, scientists, and policy makers was also to assume that they were seeing a variant of something they had encountered in the past -an atypical pneumonia or a disease caused by chlamydia (normile ; who a) . in sars, as in clarke's cases, suppressing information allowed actors at least temporarily to move forward with existing routines. even when divergent views are not completely suppressed, the context in which information is considered can shape conclusions. in last best gifts, healy ( ) asks how the major organizations supplying blood and blood products to american patients responded to early evidence that hiv could be transmitted through their products. in the american blood industry, a nonprofit whole-blood sector (the blood banks), reliant on donors, coexists with a for-profit plasma industry (the plasma fractionators) that purchases plasma from suppliers. between and , when no one was sure whether hiv could be transmitted through tainted blood and blood products, the us centers for disease control (cdc) presented their accumulating evidence and made recommendations about how to keep blood supplies safe (healy : - ) . representatives of blood banks and plasma fractionators received identical information, often at the same meetings. interestingly, though, these two sectors interpreted the information differently and adopted divergent strategies. blood banks, dependent on donors, saw blood borne transmission as 'still unproven' (healy : ) and were unwilling to ask intrusive questions about donor lifestyles and sexual practices. in contrast, plasma fractionators, working in a competitive market that made them more dependent on consumers than suppliers, adopted a policy of questioning potential donors and excluding putatively high-risk groups from their supplier pools. in short, the negotiated information order of the plasma fractionators led them to see the early information about hiv transmission as knowledge to be acted on, while blood banks' information order constructed the same information as non-knowledge to be ignored. with sars, people in different social contexts not only interpreted the data differently but also concluded that the data implied different things about their obligations under the ostensibly clear rules of the ihr. the final example shows how attempts to solve a new problem, not easily managed within the constraints imposed by an existing information order, can lead to modifications in that information order and changes in power relations in the field. contrasting the insurance of mobile rigs used for exploration and drilling with the insurance of fixed platforms used later for the production of oil in the norwegian north sea, heimer ( a) shows how norwegian insurers gradually altered the negotiated information order dominated by powerful british marine insurers. during the crucial early period of the exploration and development of the oil fields, insurers lacked the experience-based information needed for rating and underwriting, making them dependent on the reinsurance offered by british insurers. because multiple companies had to cooperate to assemble these insurance contracts with their uncertain risks and astronomical face values, insurers had to agree about what information was acceptable for rating and underwriting. british insurers stubbornly insisted on using conventional types of information. some types of information that, from a norwegian perspective, addressed key uncertainties thus could not be used simply because they had not been used in the past; social sufficiency dominated (alleged) technical sufficiency because of the requirement for consensus. because the total insurance capacity was insufficient to adequately insure the north sea oil fields, norwegian insurers were strongly motivated to create new routines for collecting and analysing data. they worked around and then modified conventions about what information could be used for ratemaking and underwriting. and gradually the situation changed. for mobile rigs, experiencebased data slowly became available and pooling risks over time and over similar units became increasingly feasible. this in turn further decreased dependence on the british reinsurance market and enabled norwegian insurers to be more flexible about what data to use and how to construct the policies. in contrast, little changed in the insurance arrangements for fixed installations, which were more expensive, less uniform, less numerous, and introduced later in the development of the oil fields. in the sars case as well, as we will see, pressure to change the rules became acute when new sources of helpful information became available but could not be efficiently exploited unless rules and norms were modified. as these examples demonstrate, organizations' information use is strongly shaped by social conventions. negotiated information orders spell out the relationships among different categories of knowledge and non-knowledge -what is known, acknowledged to be known, supplied by official sources, categorized as socially sufficient and therefore available for use versus what might be known, with varying degrees of uncertainty, but cannot be acknowledged or officially used. non-knowledge, which often comes from unofficial, back-channel sources, may be disregarded because it seems dangerous, threatening, harmful, or simply uncertain; ignored because decision makers are reluctant to bear the costs of retooling to collect, evaluate, and use new forms of information; or discarded because of the symbolic importance attached to information from official sources and the rights accorded to those who possess such high-value information. negotiated information orders thus introduce a modicum of stability in information use for some period of time until a new opportunity or danger arises. when that occurs, key actors pointing to the strategic value of certain information may successfully advocate for the reclassification of some non-knowledge as usable and technically sufficient and for the renegotiation of the information order. the arrival of a new disease -hiv, for the negotiated information order of the american blood industry; sars, for the ihr, the corresponding information order of global public health governance -can bring into sharp relief the irrationalities of established understandings about the reliability of information and the appropriate ways of using it. this article draws on a case study of sars to demonstrate how the deficiencies of the existing information order, institutionalized in the ihr, became painfully apparent in the wake of the epidemic. recognizing the substantial contributions that unofficial, previously illegitimate sources of knowledge could make in the fight against deadly infectious disease in turn helped to solidify the consensus around ihr reform efforts already underway in - when the sars epidemic occurred. in preparing this article, i have drawn especially on primary who documentation about the ihr and sars epidemic, supplemented by reports and commentaries from governmental bodies (e.g., the cdc and us congress) and non-governmental organizations and policy institutes (e.g., the national academy of medicine and chatham house). i have also drawn extensively on existing journalistic and scholarly accounts chronicling and analysing various features of the epidemic and scholarly articles and books investigating the epidemic's legal ramifications and the revision of the ihr. these documents were drawn from a larger body of primary and secondary materials collected primarily in - for a larger project examining the relationship between law and globalization in healthcare more generally. the article contends that in this case, a strong argument about technical sufficiency ultimately led to a new rule system that recategorized such non-knowledge as socially sufficient, legitimate, usable knowledge. international disease surveillance and global health governance have a long history before the sars epidemic. this history includes a century of international sanitary conferences to standardize quarantine regulations to prevent the spread of cholera, yellow fever and plague (and, previously, relapsing fever, typhus and smallpox); the crafting and revision of the international sanitary regulations (first written in ); and the formation of a series of international organizations to oversee disease surveillance and international public health, culminating with the creation of the world health organization, whose member states formally adopted the international sanitary regulations in . revised and renamed the international health regulations (ihr) in , these rules were in turn replaced by the revision, which went into effect in (fidler ; fidler and gostin ; gostin : - ; scales : - ) . a key issue in these agreements has been the collection and publication of information about disease outbreaks, with careful rules about who has to report and to whom, what they must report about, and what information they must transmit -in short, a negotiated information order that became more fully institutionalized over time. only with transparency, the argument went, was there any hope of protecting public health and curbing the spread of disease. yet, as the history of disease surveillance makes clear, because nations also worry about threats to trade, tourism and national reputation, they often strategize about what to reveal and on what timetable, hoping that diseases can be brought under control before discrediting information damages the economy or spoils the national reputation. the objective of the international conferences, conventions, and the ihr has been to induce more timely and more complete sharing of information, previously narrowly focused on reporting on a few infectious diseases and now more expansively redefined to include both infectious diseases and a wide variety of other threats to public health, by recognizing and working with this tradeoff. under the ihr (who ) , security against the spread of disease was to be achieved by requiring member states to notify the who of disease outbreaks within their borders (part ii, notifications and epidemiological information, articles - ) and maintain public health capabilities at ports and airports to monitor and reduce cross-border transmission of disease (part iii, health organization, articles - ). minimization of interference with trade and travel was to be achieved by specifying the range of responses states would be permitted or required to take in response to public health threats (part iv, health measures and procedures, articles - ). in effect, commitments to report outbreaks were traded for promises that responses to such information would be moderate, reasonable and scientifically grounded. even with this exchange in place, though, the record of compliance has been poor, and poor on both counts (carvalho and zacher ; fidler : ; kamradt-scott : - ; scales ; woodall ) . countries frequently failed to report disease outbreaks, but they also imposed overly restrictive protective measures, including quarantines and outdated vaccination requirements, that violated the spirit and the letter of the ihr rules on trade and travel. diseases continued to spread across borders whether or not travellers and goods were impounded, quarantined or otherwise delayed. although neither the who nor the member states seemed very committed to it, as the governing information order, the ihr continued to be consequential in shaping the circulation of information, categorizing information as actionable or not, and providing an excuse for states to shirk or evade pressures to report even as new transparency norms were emerging. the ihr's history suggests that this information order is primarily organized around concerns with trade and travel and has favoured the interests of rich countries (chorev b; fidler ; kamradt-scott ) . similar patterns of favoring the interests of rich countries in global health governance have been noted by other scholars (king ; erikson ; but see wenham on recent changes in emphasis). 'the rising commercial costs imposed by a system of uncoordinated, unregulated national quarantine practices meant that trade rather than health drove the development of international governance on infectious diseases', concludes fidler ( : ) . quite emblematically, the treaty and its predecessors focused only on diseases that seemed likely to be spread by trade and travel, and particularly those that might move from poor to rich countries. infectious diseases that plagued only poor countries, such as polio, were not listed, and south-south contagion was a secondary concern. adjustments were unidirectional: diseases were removed from the list, but re-emerging or new diseases were not added; no adjustments were made to take account of changes in modes and speed of transportation. the official rules of the ihr in some senses imagined a static information order in which states interacted with the who -what fidler ( ) describes as a westphalian system. yet the information order has evolved over time in important ways, with the official information order often out of step with informal practices. two key drivers of change have been innovations in information technologies, which vastly increased the amount of information available while simultaneously reducing state control of information, and the creation of new types of actors in the loosely organized global public health system. as reporting rules were first being developed, it was diplomats who certified that a ship's last port of call was disease free, allowing ships to avoid quarantine as they entered ports to offload cargo and passengers (fidler : ) . although diplomats no longer verify bills of health, the treaty's reliance on national reporters remains a core element of the reporting framework even though the new categories of actors (ngos, ingos, international health workers, laboratory workers, scientists, etc.) have access to much relevant information. thus an evolving information order peopled with these new actors co-existed with a static legal framework that only recently acknowledged and incorporated them. this meant that the who was unable to act even when it possessed information that it believed to be technically sufficient. because it was bound by a strictly formalized set of rules (few things are more rigid than a treaty with a long list of signatories), it could not adjust to evolving communication patterns. although analysts have often described disease surveillance as a collective action problem in which the global interest in transparency is pitted against national interests in episodic strategic concealment, characterizing the problem this way vastly understates the complexity of the interactions among actors. in particular, although it is nation states that have ihr treaty obligations, information about disease may be generated and controlled not only by non-state actors (as mentioned above) but also below the level of the nation-state, by agencies of the state, provincial health departments, individual public or private hospitals, and doctors and other medical personnel. as we will see, the norms and rules about how these lower level actors fit into the ihr negotiated information order have not always been entirely clear. until recently, the ihr made the who exceedingly dependent on official country reports by prohibiting the use of other sources of information. although promed-mail became an important unofficial source of information about threats to public health after its founding in , for many years the who was constrained from officially using it (woodall ). over time, the who's stance on these alternative sources of information evolved. a world epidemiological record piece suggested that 'public health authorities should give more attention to information from sources other than the public health sector, including ngos and the media. the capacity of public health authorities to rapidly respond to outbreak-related information from any source is essential for the efficiency and credibility of the entire surveillance effort' (who : ) . as the volume of information available from electronic sources and from health experts dispersed around the world increased, the pressure to use such information also increased. with increasingly sophisticated tracking systems, for instance, it became possible to demonstrate that deaths (even of particular named individuals) could have been prevented by earlier issuance of travelers' advisories (woodall ) . often, though, sub rosa information was less useful for issuing official warnings than for pressuring countries to report or for asking pointed questions about the adequacy or accuracy of reported information. 'they have accused us of spreading unfounded rumors and posting reports that have had no peer review. but we're just reporting what is being said or published. we tell health officials, you might as well report this, because you'll be reading it on promed tomorrow', commented charles calisher, an early moderator of promed (miller ) . some kinds of action required only that information be seen as technically sufficient (adequate in volume and coverage), but other kinds of action required that information also be socially sufficient (supplied by legitimate sources and arriving through specified routes). were the ihr ever an effective information order? undoubtedly the treaty was an improvement over earlier agreements, both in clarifying expectations and obligations and in institutionalizing a set of practices for reporting on disease outbreaks and keeping protective reactions in bounds. although it was an admirable attempt to create a worldwide consensus that balanced health interests against economic ones, it also had several clear deficiencies. an especially important deficiency was the limited coverage of the ihr, which cast doubt on the legitimacy of the treaty. beyond this severely limited coverage, the ihr were also compromised as an information order by a naïve conception of states as unitary actors and by rules that allowed the who to use only limited kinds of information supplied by specified, state-based actors. over time, informal norms supported fuller reporting on a broader range of threats and exploitation of information from unofficial as well as official sources. but in the medium term, although some nation-states adhered to the new norms, others hid behind the inadequate formal rules of the ihr, and still others continued to ignore even the limited formal requirements of the ihr. how well did this imperfect, outdated information order function when the ihr encountered sars, a new, deadly infectious disease that seemed poised to spread rapidly around the world? did the deficiencies of the information order in fact prevent the who from acting quickly and appropriately to contain the disease? many accounts of the - sars episode describe the chinese as concealing information or misrepresenting the situation in the first months, often suggesting that the country acted illicitly or illegitimately in doing so (altman ; the guardian ). yet closer examination of the record (see especially huang ) suggests that something considerably more complex occurred -there were multiple legitimate reasons for china to conceal early evidence of the outbreak. to begin, during the first days, there was nothing to report because no one understood that this was a new viral disease. because most apparently new diseases are in fact not new, physicians are reminded to think of horses not zebras when they hear hoof beats. as perhaps happened with sars, this advice sometimes leads people astray. with the benefit of hindsight, it is easy to conclude that chinese health workers should have been more diligent in forwarding reports about early cases of 'atypical pneumonia'. but we must be careful not to interpret actions taken in the confusion of the earliest days with knowledge acquired only later. still, local hospitals did call on provincial authorities for help. provincial authorities contacted the national ministry of health. a group of experts conducted an investigation. a report was prepared and circulated to all of the hospitals in the province. but here chinese law altered the disease's trajectory because the report became a state secret that could be shared only with specified people (such as the heads of hospitals). and then the trajectory was modified serendipitously when the report arrived in hospitals during the chinese new year celebrations. because no one read or acted on the report for a three-day period, precautionary measures were not implemented, creating an opportunity for the disease to spread. as noted, several months passed between the first appearance of sars and the first reports to the who. had the first suspicious cases been reported promptly, the disease likely would not have spread beyond guangdong province and hundreds of deaths could have been prevented. reports on the case suggest that in the earliest period, people 'knew' but 'didn't know' about the epidemic. and although healthcare workers, officials and other actors suspected a problem, at least in some instances they were either forbidden to share information or prohibited from acting on the information they received. in this case, the complex interplay of international, national and local rules and norms seems to have done as much to delay as to accelerate the spread of information about threats to public health. information about sars gradually leaked out, though, with a report from the chinese ministry of health finally reaching the who on february (who d). accounts of this period mention 'medical whistle-blowers' (see, e.g., eckholm ), promed-mail, the global health intelligence network (gphin, the 'rumor list'), the global outbreak alert and response network (goarn), and the move of the disease across borders into hong kong and then vietnam. although who personnel were investigating cases of what turned out to be sars in china as early as late february (enserink a (enserink : , the who issued its first alert about a severe form of atypical pneumonia only on march . according to david heymann (then executive director of who's communicable diseases cluster), vietnam was 'the trigger' for this announcement (enserink a (enserink : . a march report from carlo urbani, a who parasitologist consulting on a case in the french hospital in hanoi, provided the first indication that the new disease had spread beyond guangdong and hong kong. (urbani himself subsequently died from sars.) with the second who announcement, the world was informed that the atypical pneumonia, now named sars, was a new and very serious communicable disease. the secret was out. during this period, it could be hard to discern the signal in the noise. many things contributed to the noise -the irreducible uncertainties of the early days of a new disease, fear, mistakes, lack of preparation, incompetence, reputational concerns, and of course deliberate obfuscation. to be sure, there was ample evidence of outright concealment, foot-dragging, and obfuscation. the guangdong provincial government 'initially banned the press from writing about the disease and downplayed its significance' (enserink b (enserink : . although the who diplomatically reported cooperative efforts (see, e.g., who b), it carefully avoided comment on chinese silence or obfuscation between november and february, and even later. in fact, although chinese officials agreed to share information, their first promises were followed by more deceptions (fidler ; huang ; knobler et al. ). when the chinese government began to share information, who officials were still unable to get meetings with chinese health officials and were refused permission for travel to guangdong (enserink b (enserink : . when the early undercount of sars patients was attributed to the inadvertent exclusion of patients in military facilities, eckholm pointed out that the high proportion of beijing sars patients in military hospitals 'could [instead] indicate that patients were placed there to avoid their inclusion in civilian disease reports ' ( ) . what the nation-state does not know, it cannot report. but the ihr was little help in dampening the noise or strengthening the signal. although the ihr treaty was officially the governing document when the - sars outbreak occurred, it was an imperfect information order that did not authoritatively mandate a clear course of action. '[n]othing compelled china, or any other country, to tell the rest of the world what was happening within its borders early in ' (enserink b (enserink : . indeed, the shocking weakness of the international health governance system was surely a factor in china's failure to report the outbreak quickly. under the ihr, most disease outbreaks, including those of previously unknown diseases, were domestic business. but if china had no formal obligation to report, why was it so soundly condemned for its delay in transmitting information to the who? although the treaty -international law -did not require reporting, emerging norms around the management of global public health governance diverged from formal law. under these emerging norms, a failure to report a new disease, an environmental disaster, or some other occurrence that might affect global public health was a serious infraction (heymann ) . indeed, it was the conflict between these emerging norms and the existing treaty provisions, along with the emergence of new infectious diseases like ebola, that helped spur the ihr revision, first called for in a resolution, well ahead of the sars outbreak. an important difference between formal treaty obligations and norms, though, is that the first applies uniformly and the second does not. being a signatory to a treaty is a bright line. membership in a moral community is more ambiguous, with some treaty signatories more fully incorporated and others more peripheral. thus although the long silence of the chinese government was not technically a violation of the ihr, it nevertheless appeared dishonest and inappropriate to the international community, undermining rather than supporting emerging cooperative norms and in fact harming global public health by allowing the new disease to spread beyond china's borders. the institutional incoherence around global public health governance was in fact deeper than this; the treaty provisions were inconsistent with domestic law as well as with emerging norms. until treaty provision and domestic law are harmonized, health workers can be caught between local and global legal obligations, two distinct sets of rules laying out inconsistent requirements for partially overlapping groups of actors. although only state representatives were responsible for reporting to the who, domestic law compelled medical workers to preserve state secrets about the very matters that international norms -but not ihr treaty provisions -compelled them (or others in their chain of command) to report. many chinese actors were in a terrible bind, legally required to protect state secrets but morally obligated to share information so fellow citizens could protect themselves from a virulent emerging disease and so international bodies could study the disease and develop methods to combat it. individual and global interests both demanded transmission of information, yet the chinese state initially mandated secrecy instead. moreover, the ihr specified roles and obligations for only a few actors, thus offering no guidance about appropriate courses of action for many other actors who possessed relevant information. beyond legalistic matters about obligations to report or to conceal, the evidence from sars also suggests that fears about economic consequences of adverse publicity associated with disease outbreaks strongly shaped the thinking of chinese authorities (huang : ) . these economic concerns were in fact justified, though overstated, in hindsight. the economic effects of sars include much more than the cost of providing medical care for those affected, as analysts acknowledge. lee and mckibben ( ) estimated the short-term impact of sars to be about $ billion for alone if people expected the epidemic to be a one-time event and considerably higher if they behaved as if they anticipated recurrences. subsequent research suggests that the economic impacts were considerably smaller than anticipated and that recovery occurred quickly (keogh-brown and smith ) . although the economic impact was widely dispersed, the losses were greater in asian countries than in the rest of the world, with strong shocks to mainland china, which experienced a decline in foreign investment, and especially to hong kong whose service economy depends on travel and tourism. for government officials responsible for the overall welfare of a society, including both physical and economic health, worries about commercial impacts cannot be dismissed. as a negotiated information order, the ihr was thus ineffective, unstable, and ripe for change for a host of reasons. first, legal obligations were out of sync with the higher expectations of an evolving normative system. second, international law and domestic law often had not been harmonized and disagreed about whether threats to public health should be reported or kept secret, creating a serious conundrum for health workers. third, the ihr failed to take account of the social complexity of a system in which information was produced and controlled by a wide variety of actors, including not just official national representatives (e.g., ministries of health) and provincial or other substate actors (e.g., provincial departments of health), but also actors who were not state representatives but nevertheless had relevant roles and expertise (e.g., heads of hospitals, whether private, public or military), journalists, and private citizens all with varying relationships to the international treaty, emerging norms, and domestic law. fourth, although the ihr did not envision that the who would act on the basis of information other than that provided officially by nation-states, pressure to use such 'non-knowledge' had increased over time as information sources multiplied, tools to parse such information were created, and threats to public health came to seem increasingly urgent. one important effect of sars was to shift the boundary between official and unofficial knowledge, ultimately modifying the information order so that unofficial information of questionable quality could be used as leverage, forcing states to reveal what they might have preferred to conceal. the revision of the ihr was adopted by the world health assembly (wha), the governing body of the who, in and put into force in . just as revisions to the ihr were being crafted, the deficiencies of the existing legal framework were made glaringly apparent by the rapid spread of sars and the numerous -and avoidable -deaths it caused. although china had not in fact violated the existing treaty, it clearly violated emerging norms on the reporting of infectious diseases. the objective of the new treaty provisions was to induce earlier and fuller reporting by acknowledging the importance of non-state actors as suppliers of information and recrafting the information order so that previously unusable kinds of information -information that might have been seen as technically sufficient but was not socially sufficient -could now be used. the revision brought important changes in what has to be reportedany 'public health emergency of international concern'. along with this broader range of reportable threats, the ihr introduced a decision tool to replace the short, simple list and guide reporting; offered considerable guidance about who should report and how (e.g., mandates for designated reporters, now called 'national focal points'); and created tool kits for implementation including for harmonizing the ihr with domestic law (who ). in effect, these changes move the ihr from the realm of 'soft law' further into the domain of 'hard law' (abbott and snidal ) by making the rules more specific and more obligatory, by adding processes for interpretation of law and for dispute settlement, and by inserting rudimentary enforcement mechanisms. some of the work of hardening the ihr is delegated to individual member states as they bring domestic law into harmony with the ihr. as treaty provisions and domestic law are harmonized and gaps bridged, excuses for non-compliance are eliminated and domestic supports for compliance are added (see, e.g., the agreement between the australian federal government and its states and territories to ensure timely reporting [commonwealth of australia ; scales : ]). fidler ( ) argues that sars exposed the conflict between an outdated, unworkable, westphalian system of international governance and a world in which global diseases required a global governance system. states have lost their primacy, he suggests, in a world in which they can control neither the movement of disease nor the movement of information. believing it had the right to suppress information, the chinese government attempted to treat information about infectious disease as it always had: as a matter of state secrets. but in a world of cell phones and internet, text messages and email allowed both patients and physicians to circumvent the state. prohibiting news media from reporting the outbreak of the deadly disease did not keep individuals from communicating with one another inside china and sending information and questions to contacts outside the country. with the growth of new information technologies, state monopolies on information have decayed and the balance between socially and technically sufficient information has shifted. as the volume of information considered technically sufficient has increased and the who has developed more sophisticated techniques for extracting high-quality information, its capacity to pressure states to meet their treaty obligations has increased. something like an enforcement capacity, albeit one not formally recognized in the ihr, grew up in the midst of all this complexity. with the vote of the world health assembly (wha) and the subsequent revision of the ihr, this enforcement capacity has been recognized, endorsed and formalized, first with the wha's blessing of the who's use of unofficial information and then with the incorporation of this information use into the procedures outlined in the revised ihr. in this case, changes in practice preceded changes in the legal infrastructure as the who increasingly drew on information that did not come directly from the official reporters of member states. but in a pattern of 'punctuated globalization' (heimer ) , the legal framework seems now to have reclaimed the lead in moving forward global coordination around public health surveillance. as countries and agencies adjust to the ihr, we can expect the development of a host of new strategies for exploiting the opportunities created by this new framework. the revisions have required many countries to invest heavily in improving their systems for tracking and reporting threats to public health. this, in turn, has created an opening for many joint activities between rich and poor countries, including construction of new cdc facilities around the world (gootnick ) . do these changes then signal the end of the gap between actionable, socially sufficient information and technically sufficient information in global health governance? rather than an end to the gap, we should expect a shift of the gap's location. gaps arise because parties with imperfectly aligned interests have some incentive to game systems. such discrepancies between global, collective interests and regional, state or local interests will continue to exist and some evidence suggests both continued and fresh strategies for gaming and non-compliance (scales : - ) . the exact configuration of the gaps will change, of course, as the nature of the key actors changes (less emphasis on states, perhaps) and as technologies change (easier transmission of information by both official and lay actors). the gap itself will not vanish. states will remain relevant actorsindeed world politics suggests that national borders are as often reinforced as demolished and that states continue to have responsibilities and interests that might motivate them to conceal information. moreover, a clarification of treaty obligations and the introduction of a new lever for the who will not entirely resolve the problem. in the past, with no uncertainty about obligations to report, countries nevertheless failed to report outbreaks (carvalho and zacher ; fidler : ; kamradt-scott : - ; scales ) . although the who can more nimbly alert the world about an outbreak, it can do little beyond that: no sanctions, no fines, no cancellation of membership. and new incentives for non-compliance will continue to arise. until samples were used to create flu vaccines, countries had little reason to withhold samples of new influenza strains. but under a regime that protects intellectual property and gives those supplying samples no share of the income from the sale of resulting vaccines, countries now have an incentive not to offer their samples for the common good. when indonesia, responding to this incentive structure, began withholding flu samples, a new who working group developed a non-binding framework to encourage both virus and benefit sharing (fidler ; fidler and gostin ; scales ; smith ) . in the argument of this article, sars plays a central (albeit non-determinative) role. but is sars simply a useful case on which to hang the argument? or could the argument have been built around hiv/aids, h n , ebola, zika, or some other infectious disease? in fact, other diseases and sars are not interchangeable in this argument; sars is not 'merely' an example. because of historical timing, sars was the epidemic that brought the previously recognized failings of existing disease surveillance systems into the spotlight and stiffened the spines of those pushing for change. the features and timing of sars helped to bring the shortcomings of the ihr into sharp relief, undermining their legitimacy and making it essentially impossible for the who and public health specialists to continue working under the old rules. the legitimacy of the who increasingly depended on denying the legitimacy of the ihr. by the time sars appeared, the deficiencies of the ihr had become so glaringly apparent that the wha had endorsed the who's use of unofficial information even before the rules changed. but particular features of the disease, namely its brief incubation period and moderate transmissibility, meant that the adage that microbes do not respect national borders was all too applicable. local outbreaks of sars had global relevance in a way that local outbreaks of hiv/aids, with its long period of dormancy, did not. sars quickly became a global threat. but it also mattered that the disease arose in a country that wished to suppress information about the outbreak. in the age of the internet and cell phones, information, like microbes, neither respects borders nor governmental edicts on secrecy. thus sars brought to a head a long-standing clash between national governments' desires to keep secrets and new capacities to transmit information with or without governments' blessing. in fidler's view, 'china's behavior [at the start of the sars epidemic] put the final nail in the coffin of basing global surveillance for infectious diseases only on government information ' ( : ) as the rules required. sars was a 'historic moment in public health governance' (fidler : ) , the tipping point for new governance strategies (fidler : ) . in a limited sense, then, sars was a boon to the who because it provided an added inducement for the wha and member states to modify the rules in ways that benefited the entire group and gave the who and ihr new relevance. although the ihr's limitations had long been apparent, by making it impossible to deny that the treaty provisions were outmoded sars accelerated the process of reaching consensus on proposed changes. the revisions of the ihr attempted to deal with two kinds of ignorance: ignorance about outbreaks of known diseases and ignorance about newly emerging diseases and other threats to public health. before revision, the ihr had focused only on outbreaks of known diseases and therefore on ignorance that could in principle be reduced or even eliminated by full and honest disclosure. as it became clear that infectious diseases were not going to be eradicated, as new diseases continued to emerge, and as natural disasters, industrial accidents, air and water pollution, and so forth came to be understood as threats to public health, the ihr's focus shifted to these less tractable forms of ignorance and thinking changed about what should be reportable under the ihr. this expanded understanding of threats to public health brought both expanded obligations for states and expanded obligations for the who. the who's remit now included not just spreading the word and issuing advisories about a larger package of threats to public health, but also overseeing and orchestrating the scientific work of untangling the etiology, symptom patterns, modes of detection, and effective remedies for these threats. into this changed environment, the reworked information order introduced a more sophisticated understanding of the relationship between what was or could be known and what was unknown and perhaps even unknowable. the modified procedures of the ihr in some senses acknowledged the difference between technically sufficient information that was also socially sufficient -because it had been supplied by mandated state reporters -and technically sufficient information that was not socially sufficient because it travelled to the who by unconventional or even clandestine routes. but the loosening of constraints on the sourcing of information did more than simply make information usable by recategorizing previously unofficial, socially insufficient information. the modified procedures also opened the door to using information as leverage, with information of inferior quality or illegitimate provenance being used to pry loose information of better quality or from official sources. moreover, in casting a wider net and exhibiting its willingness to draw on an expanded network of informants and more variable kinds of information, the ihr seem to acknowledge the essential irreducibility of ignorance. when uncertainty cannot be eliminated, and when the transmission and withholding of information is at least in part a strategic game, an entity such as the who is in no position to sharply limit the information it will consider. the ihr, a renegotiated global public health information order, thus incorporate into their structure an acknowledgement of the complex relationship between knowledge and ignorance, socially sufficient information and technically sufficient information, and the socially constructed nature of these distinctions. although this article focuses on negotiated information orders in global public health governance, its argument and evidence address broader issues about how global norms change and how social groups manage risk. the story of the - sars epidemic, the core empirical component of the article, is about the possibility that a virulent new disease would become a devastating pandemic and about an emerging (but not yet formalized) obligation to inform the who about serious threats to public health. the comparison points -the threat of aids contamination in banked blood (healy ) ; threats from oil spills, nuclear power accidents, and nuclear war (clarke ) ; and threats from accidents on north sea oil rigs and platforms (heimer a ) -are also about how key actors assessed novel risks. in all of these cases, the assessment of the core risk was implicitly balanced against other risks -risks to trade and tourism for sars; risks to relationships with important constituencies for the blood banks (healy ) ; risks to desired investments in business and government enterprises (clarke ) ; and risks to vested interests in the insurance business (heimer a) . generally speaking, though, as discussions unfolded, only some of the risks were fully on the table, perhaps because people were not wholly aware of how other considerations were shaping their thinking, perhaps because of the questionable legitimacy of balancing other risks (trade and tourism, in the sars case) against threats to life and health. the result is often a pattern of minimizing assessments of danger and normalizing those (implicit) assessments. as noted earlier in the article, many disease outbreaks, even of the three reportable diseases, had not been reported to the who. somewhat like the normalization of deviance that diane vaughan ( ) so carefully describes in the challenger launch decision, the deviant non-reporting of disease outbreaks had been normalized. some countriesespecially poorer ones -were learning from one another that they would suffer no consequences from ignoring ihr treaty obligations. although the ihr were described as regulations to protect health in all countries, in fact they focused on stemming the spread of disease from poor countries to richer ones. as chorev ( a) suggests, international obligations perceived as coercive are more likely to be reinterpreted locally and perhaps ultimately transformed through processes of reactive diffusion. in the case of the ihr, reactive diffusion essentially made the already unenforceable ihr progressively less useful. but in the pre-sars period, the evidence in fact suggests a more complex process of normative change. two rather different norms were being institutionalized simultaneously in global public health governance. at the same time that ignoring ihr treaty obligations was becoming the norm in some circles, a different norm was spreading in other circles. some countries -especially the richer ones -were adopting a more cooperative stance, sharing information not only on ihr reportable diseases but also on other infectious diseases and threats to public health. it was this cooperative norm, not the norm of non-reporting, that ultimately diffused and, coupled with the sars epidemic, led to a reinvention of the ihr as a treaty with a few more teeth. how did this happen? here a comparison with the space shuttle launch decision is instructive. although nasa carried out rigorous, carefully scripted pre-launch reviews, contextual pressures to launch could subtly shift thinking about which risks could be dismissed and which warning signs ignored. over time, these modified assessments were institutionalized and the insularity of the process made it hard for alternative viewpoints to force a recalibration. the conflict between protecting against rare events and attending to business is utterly mundane (vaughan ) , so mundane that insurers have institutionalized methods for protecting key risk management tasks from production pressures (heimer b) . the job of the ihr, arguably, is to rebalance risk assessments so global public health interests are not regularly sacrificed when discrediting information about health threats is concealed to protect a country's trade and tourism. yet the ihr treaty gave the who few levers to induce such a rebalancing. unlike space shuttle launch decisions, though, global public health governance does not take place behind a single set of closed doors. thus, although a practice of non-reporting -normalized deviance -seemed to be developing in some sectors, changes in information technologies and communication patterns made secret keeping more difficult and shifted the balance in favour of the more cooperative norm. even with china's strict control over the internet and the press, text messages and emails spread news about 'atypical pneumonia', forcing public officials to acknowledge the outbreak. although any single medium might fail to pick up the news, the proliferation of methods for detecting signals makes suppression of information more difficult. a news blackout might make gphin, which scrapes information from news outlets, less effective, but have less effect on promed-mail, which relies on medical workers' postings. working together over some considerable period of time and in a series of discrete steps, the new information technologies and the emerging norm of information sharing reconfigured the rules about global public health governance and reshaped understandings about what information could be used and who could supply it. information technologies first reshaped some practices of the who. as the who began to use the unofficial information supplied by entities like gphin, it also initiated the process of redefining non-knowledge as technically sufficient, at least for some purposes. as the who rebuilt its routines to use unofficial information alongside official country reports, new relationships and resources (e.g., goarn) were created around those new information sources. both the suppliers of information and the who increasingly treated this new information as technically sufficient. with the endorsement of the wha, these new practices and new definitions of the adequacy of unofficial information were further institutionalized, moving one step further to a formal change in the treaty itself. with the adoption of the ihr, the process was complete -what had previously been categorized as unusable non-knowledge was first reconceptualized as technically sufficient, and ultimately accepted as socially sufficient for use in an expanded menu of actions. nevertheless, information categorized as unusable non-knowledge will always exist and will continue to be important precisely because it comes from different social locations than those tapped by official information. as mary douglas would remind us, we need the sentinels on society's margin to warn us of unexpected dangers every bit as much as we need people working in core institutions to protect us from more routine risks (douglas and wildavsky ) . although admittedly the uses of non-knowledge or clandestine knowledge are typically different than the uses of official knowledge, that should not lead us to underestimate either the vital strategic value of non-knowledge or the importance of using it efficiently in a smoothly functioning, adaptable information order. just ask kim philby or david john moor cornwell, aka john le carré. gphin in (who c , notes that '[m]ore than % of the initial outbreak reports come from unofficial informal sources, including sources other than the electronic media, which require verification' (who n.d.) . gphin is often credited with picking up news of a disease outbreak in china in late november (heymann and rodier : ) . set up in by the who and formally launched in , goarn is a collaboration of other networks, linking a wide variety of experts and combining both surveillance and response (fidler ; heymann ; heymann et al. ; who c: ) . as of , goarn includes as members over technical institutions and networks concerned in one way or another with public health (https://extranet.who.int/goarn/; last viewed march ). fidler ( ) , especially, credits goarn with a major role in containing sars. according to virologist malik peiris, 'if something untoward was happening across the border, it would come to hong kong pretty quickly' (enserink a (enserink : . vietnam was a reluctant trigger, though. as hospital staff fell ill, the vietnamese government had to be persuaded that this was not simply a 'private problem in a private hospital' but might instead be 'very important' (enserink a : . according to the who, the resurgence of cholera in south america and plague in india, as well as the emergence of new infectious agents such as the ebola virus, 'resulted in a resolution at the th world health assembly in calling for the revision of the regulations' (https://www.who.int/ihr/ about/faq/en/; last viewed march ). some observers (e.g., katz and fischer ; wenham ) contend that states have not lost their primacy. for similar assessments of the role of sars, see lazcano-ponce, allen and gonzález ( : ) and katz and fischer ( ) . to be sure, the new technologies were not free, and wenham ( ) notes that considerable human intervention was required to make sense of the volumes of information arriving through gphin and goarn. but these costs were disproportionately borne by richer countries, who also agreed to help build infrastructure and supply expertise for poorer countries. hard and soft law in international governance the market for "lemons": quality uncertainty and the market mechanism uncertainty and the welfare economics of medical care the international health regulations in historical perspective changing global norms through reactive diffusion: the case of intellectual property protection of aids drugs the world health organization between north and south a garbage can model of organizational choice risk and culture: an essay on the selection of technological and environmental dangers war stories sars: chronology of the 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'epidemic intelligence -systematic event detection international health regulations ( key: cord- - yjl x authors: waitzkin, howard title: confronting the upstream causes of covid- and other epidemics to follow date: - - journal: int j health serv doi: . / sha: doc_id: cord_uid: yjl x the upstream causes of the covid- pandemic have received little attention so far in public health and clinical medicine, as opposed to the downstream effects of mass morbidity and mortality. to resolve this pandemic and to prevent even more severe future pandemics, a focus on upstream causation is essential. convincing evidence shows that this and every other important viral epidemic emerging in the recent past and predictably into the future comes from the same upstream causes: capitalist agriculture, its destruction of natural habitat, and the industrial production of meat. international and national health organizations have obscured the upstream causes of emerging viral epidemics. these organizations have suffered cutbacks in public funding but have received increased support from international financial institutions and private philanthropies that emphasize the downstream effects rather than upstream causes of infectious diseases. conflicts of interest also have impacted public health policies. a worldwide shift has begun toward peasant agricultural practices: research so far has shown that peasant agriculture is safer and more efficient than capitalist industrial agricultural practices. without such a transformation of agriculture, even more devastating pandemics will result from the same upstream causes. while struggling to lessen the many downstream effects of covid- , through dangerous and sometimes heroic efforts, we in medicine and public health also must try to maintain a clear and relentless focus upstream on the root causes of the pandemic. clarity about the upstream causes rarely emerges in current discussions of the pandemic, even in the scientific and public health communities, and hardly ever in pronouncements of the public health institutions on which many of us rely: the world health organization (who), u.s. centers for disease control and prevention (cdc), u.s. national institute of allergy and infectious diseases, pan american health organization, gates foundation, and so forth. identifying the upstream causes of epidemics has been a central goal of epidemiology since the s, when the pathologist rudolf virchow did his path-breaking investigation of the typhus epidemic in upper silesia. due to the current pandemic's magnitude, one would expect that the upstream causes would be crystal-clear for all to see, so we could address them directly, but amazingly this is not the case. many people attribute the origins of the pandemic to the strange and retro marketing practices of some individuals and groups in wuhan, china, who were selling wild animals in the market from which the virus spread, eventually worldwide. but such marketing practices have been going on for a long time, probably hundreds of years or more. why do we have a pandemic now and not earlier? this pandemic and every other important emerging viral epidemic in the recent past and predictably into the future come from the same upstream causes: capitalist industrial agriculture, destruction of natural habitat, and production of meat. in recent decades, the intensity and worldwide scale of these practices have increased rapidly. pioneering microbiological and epidemiological studies have clarified these upstream causes of emerging epidemics, whose effects we now are confronting every day. [ ] [ ] [ ] [ ] [ ] [ ] in addition to viral epidemics, these and similar agricultural practices also deepen the parallel crises of multi-drug-resistant bacterial infections (through overuse of antibiotics in industrial meat and fish production), climate change (by destruction of rainforest habitats and long-distance transportation of food that requires burning of petroleum), plastic pollution (by agricultural packaging methods), and other severe environmental problems. natural forest habitat previously provided ecological control for microbes such as sars-cov- and their hosts, such as bats. clearing habitat for industrial agriculture emerged as a central characteristic of china's economy as it "liberalized" after mao zedong into a bastion of the capitalist world system. similar zoonotic sources of transmission from destroyed habitats have happened in china with the previous coronavirus in severe acute respiratory syndrome (sars); ebola in africa; zika in africa, latin america, and elsewhere; and arguably hiv in africa. [ ] [ ] [ ] another practice stemming from the capitalist model of agriculture involves industrial production of meat. especially for pigs and chickens but also other species, reproduction of offspring, growth to adulthood, slaughter, and packaging increasingly occur under factory conditions that receive little regulatory oversight and control. worldwide, a small number of large, oligopolistic, multinational corporations dominate factory farming. as a result, viral contamination and mutations to more virulent organisms in unsanitary factory conditions have led to epidemics of swine flu, avian flu, and a variety of emerging influenza viruses. [ ] [ ] [ ] [ ] deemphasis on agriculture in public health do sources like who, cdc, and the gates foundation provide a complete picture? some well-motivated people work for these agencies, and much helpful information is available. but mistakes get made, as have occurred multiple times during the covid- pandemic, and more importantly these sources rarely address the upstream causes of epidemics. many have commented about the devastating funding cutbacks and de-prioritization that have crippled these organizations' capacity to protect public health. as just one example, the annual program budget of who for the whole world is smaller by about half than the operating budget of a large medical center in the united states (who: $ . billion; new york presbyterian hospital: about $ billion). , into the financial crisis of international health institutions have stepped the world bank, international monetary fund, gates foundation, and other agencies of "philanthrocapitalism," whose financial priorities and ideologies dominate the policies and practices of who and its affiliated organizations worldwide. this is one reason that the global people's health movement produces "who watch" and "global health watch" to monitor who critically and to offer alternatives that who and its affiliates do not pursue because of their financial dependency on international financial institutions and philanthrocapitalism. partly due to such financial support, international and national health organizations almost always promote reductionist initiatives that focus on so-called magic bullets such as vaccines and antiviral medications, as well as behavioral change at the level of individuals, rather than upstream causes. financial conflicts of interest also can distort the organizations' policies. for instance, the gates foundation has invested in and promoted genetically modified crops through such corporations as monsanto/bayer. farmlands for such crops lead largely to the production of animal feeds, required for increased meat production, which causes further loss of forest habitat. in addition, gates' investments emphasize pharmaceutical corporations and other companies that profit from intellectual property, which in the realm of computer software creates most of gates' wealth. similarly, cdc and its employees regularly attract criticism based on revelations about conflicts of interest at both the organizational level (especially regarding grants and other financial support that a foundation connected to cdc receives from the pharmaceutical industry) and individual level (employees' and committee members' investments in and gifts from industry). so who, cdc, gates, and their affiliates have obscured the upstream causes of emerging viral epidemics not only in covid- but also in all other recent epidemics. an especially disheartening example (i was involved) was the swine flu epidemic of , which began within mile of smithfield foods' notorious industrial pig farm operation in a rural area of veracruz state in mexico. smithfield foods had outsourced this operation from the united states partly to avoid occupational and environmental cleanup requirements. although mexican public health authorities and investigators reported this epidemiological association between swine flu and capitalist industrial agriculture, cdc, who, and all other international health organizations pursued reductionist strategies such as a vaccine, rather than confront radical change in the meat processing industry. during the covid- pandemic, smithfield's practices became even more startling. less than a decade after the swine flu epidemic, a hong kong-based investment corporation, wh group ltd, had acquired smithfield foods. in smithfield executives based at u.s. headquarters in smithfield, virginia, welcomed the ongoing epidemic of african swine fever because a reduced global supply of pork would lead to major increases in prices and profitability for the corporation. when covid- struck, smithfield executives reassured u.s. consumers that, despite ownership in hong kong, the corporation did not import pork from china but instead exported u.s. pork to china, where prices were higher. a smithfield pork processing plant in sioux falls, south dakota, became one of the largest covid- hotspots in the united states. rapid spread of the infection to workers because of similarly unsanitary working conditions threatened to close other meat-producing plants as well. the role of capitalist industrial agriculture through loss of habitat and meat production occasionally does surface in the mainstream media. such media attention, while limited, happened recently regarding the sources of covid- , although the term "capitalist" did not enter the discussion. but the impacts of such corporations on emerging epidemics rarely appear in communications or policies of international health organizations or the gates foundation. leaders of these agencies are fully aware that emerging viral epidemics come from capitalist industrial agriculture. they showed this awareness in event on october , , ironically about months before the covid- epidemic began in wuhan. in this "tabletop exercise," coordinated by the johns hopkins center for health security, gates foundation, and world economic forum, a novel coronavirus pandemic begins at pig farms in brazil and spreads rapidly around the world, resulting in million deaths and catastrophic effects on the global economy, political stability, and international security. after the covid- epidemic actually began, the sponsors of event emphasized that they did not predict the timing of covid- and that the projected death toll did not necessarily apply. but they did not say anything about an initiative to eradicate the practices of capitalist industrial agriculture that led to the hypothetical scenario of event , to the current global covid- pandemic, and to the inevitable future pandemics that will occur on a similar scale or even worse. is there an alternative to capitalist industrial agriculture? yes. around the world, often against resistance from corporations and governments, farmers are returning to peasant agricultural practices. a whole body of research has shown that peasant agriculture is not only safer than capitalist agriculture but actually is more efficient and productive as well. millions of people worldwide already are making this transition, often because they/we see no other choice. especially in the context of economic collapse, capitalist agriculture -with its tendency to overproduce and even destroy surplus food while hunger and food insecurity worsen -is ill suited to feed the world's peoples. changing the upstream causes of epidemics such as covid- and others yet to come becomes a key scientific and practical priority for medicine and public health, considering the future of humanity and other inhabitants of the planet. if that transformation doesn't happen, we can expect even more devastating pandemics, stemming from the same upstream causes. dedicated to the memory of john d. stoeckle -teacher, colleague, friend, comrade -who developed the upstream focus in medicine and public health and who died in april from covid- (see waitzkin ). may his efforts live on as we cope with this pandemic and struggle to prevent those coming in the future if we don't address their upstream causes. the author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. clear-cutting disease control: capital-led deforestation, public health austerity, and vector-borne infection health care under the knife: moving beyond capitalism for our health neoliberal ebola: modeling disease emergence from finance to forest and farm big farms make big flu: dispatches on infectious disease, agribusiness, and the nature of science covid- and circuits of capital impacts of environmental and socio-economic factors on emergence and epidemic potential of ebola in africa social contagion zika: the origin and spread of a mosquito-borne virus philanthrocapitalism and the global health agenda: the rockefeller and gates foundations, past and present people's health movement. global health watch, who watch tanzania orders destruction of monsanto/gates foundation gmo trials. sustainable pulse cdc "disclaimers" hide financial conflicts of interest. lown institute smithfield ceo looks ahead to : ken sullivan sees spread of african swine fever and trade deals as positive for the hog market. national hog farmer read our covid- statement. smithfield marketplace meatpacker smithfield foods becomes largest covid- hotspot in us with employees testing positive. international business times bats are not to blame for coronavirus. humans are. cnn health the event scenario the new peasantries: rural development in times of globalization stoeckle and the upstream vision of social determinants in public health the author received no financial support for the research, authorship, and/or publication of this article. key: cord- - a szj x authors: ibrahim, mohamed izham mohamed title: chapter assessment of medication dispensing and extended community pharmacy services date: - - journal: social and administrative aspects of pharmacy in low- and middle-income countries doi: . /b - - - - . - sha: doc_id: cord_uid: a szj x abstract individuals who visit community pharmacies are regarded as customers rather than patients. the public tends to view community pharmacists as businesspeople. several factors influence individuals' willingness to patronize and to continue visiting such pharmacies. on the supply side, community pharmacists' responsibilities and duties center on the health and well-being of society. in this chapter, an assessment of community pharmacy practices in developing countries is particularly interesting in terms of medication dispensing and extended pharmacy services that promote public wellness. community pharmacists in developing countries, who are supposedly strategically positioned in the community to provide public health, are not taking advantage on this opportunity. although several studies have noted the services provided by community pharmacists, in general, the practice is far from meeting expectations due to several barriers. pharmacists need to realize their opportunities and potential for success as both professionals and businesspeople. pharmacists serve individual, community, and societal needs. brodie ( ) proposed that pharmacists' basic role has to expand based on advancements in technology and knowledge. in the past, pharmacists' main purpose was to prepare medicines and to ensure their availability. however, pharmacists can now react to external forces (e.g., economic, epidemiological, demographic, and technological) that are reshaping the profession by positioning themselves within the medication use system and being in control of the process. helper ( ) suggested that pharmacists be more knowledgeable and focus on their fundamental pharmacist-society relationship to improve public health. in , who defined health in its constitution: health is a state of complete physical, mental and social well-being, not merely the absence of disease or infirmity. this is the most quoted definition of health, which clearly stresses "well-being." four decades later, who ( ) revised its definition as follows: health is the extent to which an individual or group is able, on the one hand, to realize aspirations and satisfy needs; and, on the other hand, to change or cope with the environment. health is, therefore, seen as a resource for everyday life, not an object of living; it is a positive concept emphasizing social and personal resources, as well as physical capacities. in developing countries, healthcare needs are more pressing than those in developed nations. unfortunately, for various reasons, the provision of care is inadequate, particularly in the public sector; it is even worse in the private sector. who ( ) has highlighted the importance of improving, monitoring, and evaluating people's wellness and quality of life, which, as a public health concern, should be the goals in a country's national development. in , winslow defined public health as follows: [public health is] the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals. (winslow, ) public health is an organized effort to maintain the health of the people and to prevent illness, injury, and premature death by focusing on prevention and health protection services (the association of faculties of medicines of canada, n.d.) . another relevant community-related concept is primary healthcare. primary healthcare was the core concept of who's goal in health for all, which was based on the alma ata declaration in (who, ) . due to high healthcare expenditures, moving some of the healthcare focus from the tertiary level to the primary level is perhaps justifiable. primary care also aims to decrease the public's reliance on hospitals to fill drug prescriptions. according to who, to achieve health for all, people must be put at the center of healthcare (who, ) . people-centered care is focused and organized around the health needs and expectations of people and communities rather than on disease itself (who, ) . if people and society are the core of the "health for all" mission, then where do community pharmacists belong as healthcare providers? do the pharmacy and community pharmacists fit within the system? in this chapter, an assessment of community pharmacy practices in developing countries is particularly interesting in terms of medication dispensing and extended pharmacy services. the chapter also seeks to examine the significant societal contributions of community pharmacists, including the challenges and gaps in practice. this chapter will also focus and discuss the expected role, function, and responsibilities of community pharmacists in developing countries. this is based on the aforementioned concepts of "health," "public health," and "primary healthcare." a community pharmacy is a healthcare facility that provides pharmaceutical and cognitive services to a specific community. from independently owned pharmacies to corporately owned chain pharmacies, a variety of pharmacies are in operation. in some developing countries in africa and asia, the terms "drug outlets," "retail drug outlets," "retail drug shops," and "private pharmacies" are commonly used. community pharmacists must strategically position themselves in the community to serve the public health. community pharmacies can be found on main streets, in malls and supermarkets, at the heart of the most rural villages, and in the center of the most deprived communities. in some countries, many community pharmacies are opened early and closed late when other healthcare professionals are unavailable (cpni, no date). according to who ( ) , among healthcare providers, community pharmacists are the most accessible to the public. in practice, a pharmacy provides medications and other healthcare products and services and helps people and society make the best use of them (wiedenmayer et al., ) . community pharmacists supply, dispense, and sell medications according to the law. a proper dispensing practice will interpret and evaluate a prescription; select and manipulate or compound a pharmaceutical product; and label and supply the product in an appropriate container according to legal and regulatory requirements (who, ) . in addition, pharmacy activities include a pharmacist's provision of information and instructions to patients, and, under a pharmacist's supervision, practices will ensure the patient's safe and effective use of the medicines. in some countries, pharmaceutical services go beyond these basic services. these services or functions (e.g., counseling, drug information, blood pressure monitoring, immunizations, and diabetic selfmanagement) will require professional knowledge and skills beyond those required to dispense prescription medications (wiedenmayer et al., ) . these services include all those delivered by pharmacy personnel to support the delivery of pharmaceutical care. beyond the supply of pharmaceutical products, pharmaceutical services include information, education, and communication to promote public health; the provision of drug information and counseling; regulatory services; and staff education and training (wiedenmayer et al., ) . hepler and strand ( ) coined the term "pharmaceutical care," which they defined as "the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve (or maintain) a patient's quality of life." this collaborative process aims to prevent or identify and solve pharmaceutical and health-related problems-a continuous quality improvement process regarding the use of medicines (wiedenmayer et al., ) . the philosophy of pharmaceutical care promoted in the early s is no longer new. many studies, initiatives, and interventions, especially in developed countries, have been conducted to improve patient care and health outcomes. in an attempt to provide health and pharmaceutical care to patients and society, the healthcare and pharmaceutical sectors in developing countries, particularly low-and middle-income countries (lmics), are facing challenges. these challenges include the shortage of human resources in the pharmacy workforce; inefficient health systems; the rising costs of medicines and healthcare; limited financial resources; the huge burden of disease; and changing social, epidemiological, technological, economic, and political situations (mohamed ibrahim, palaian, al-sulaiti, & el-shami, ) . in general, pharmacists play an important role in the healthcare system through the provision of medicines and information (accp, no date). pharmacists are drug experts who focus on patients' health and wellness. the competency standards for pharmacists in australia (shpa, ) mentioned several important functional areas that community pharmacists could assume: dispensing medication; preparing pharmaceutical products; promoting and contributing to the quality use of medication; providing primary healthcare; and supplying information and instructions related to health and medication. what kind of value and benefits does the public really gain from community pharmacy practice? despite the widely acknowledged potential of community pharmacies in developing countries to respond to public healthcare needs, related developments have been limited (smith, ) . in addition, the quality of community pharmacy practices has also been questioned. in many countries, especially in lmics, community pharmacists have only performed the basic or traditional role (i.e., as a drug dispenser), and they have sometimes indulged in unethical practices. studies have reported mixed findings: community pharmacies make a contribution to society, but they are also problematic (i.e., they do not meet expectations and provide low-quality services). in estonia, since the restoration of independence in , community pharmacies have become more patient-oriented, even though the government has not pressured pharmacies to offer extended services. in addition to dispensing, pharmacies still compound extemporaneous products and sell herbal medicines. community pharmacists continue to perform their traditional roles (volmer, vendla, vetka, bell, & hamilton, ) . prior to , clinical pharmacy was never practiced in community pharmacy settings in peru. however, the pharmaceutical care initiative has been reported to be growing and well supported by the law. peruvian pharmacists are encouraged to take this opportunity to expand their services (alvarez-risco & van mil, ) . in china, pharmaceutical care services are underdeveloped but, with the improvement of the chinese pharmacist law, they will become an important part of the pharmacist's professional role (fang, yang, zhou, jiang, & liu, ) . pharmacists in vietnam are encouraged to expand their role-from drug sellers to client counselors, drug treatment managers, adherence counselors, and advisors on illness prevention. pharmacies are often the first place that people visit to seek medical help, and they serve as a source of health information and services. the intervention that has empowered pharmacists to serve as client advocates and client counselors has identified a few improvements, such as knowledge, behavior, increased client satisfaction, and pharmacist-healthcare provider relationships. pharmacists can move beyond the traditional role of selling drugs to be more effective healthcare professionals, and they need continuing professional development (cpd) (minh, huong, byrkit, & murray, ) . from another perspective, evidence has shown that community pharmacists perform far below public expectations. patients have encountered several problems and challenges related to community pharmacy practice, which can be discussed according to pharmacy, pharmacist, prescription, service, and system factors. studies have reported that community pharmacists in developing countries, especially lmics, do not provide quality services. a quick look at developing countries shows that the community pharmacy practice setting is regarded as popular. unfortunately, this practice setting also presents some concerns. for example, some countries allow nonpharmacists to operate pharmacies and to handle medicines. in some countries, the practice of community pharmacy is not well regulated, with little to no minimum standard of practice (hussain, mohamed ibrahim, & zaheer, d) . many pharmacy personnel who dispense medicines are unqualified, with no college/university diploma or professional degree in pharmacy (lenjisa, mosisa, woldu, & negassa, ) . a study in turkish republic of northern cyprus (gokcekus, toklu, demirdamar, & gumusel, ) reported that the pharmacy employees have no pharmacybased training and that pharmacists believed that their employees are capable to handle the prescriptions. studies in qatar, pakistan, malaysian, and sudan have indicated that dispensing and labeling practices and provider-patient interactions are poor (alamin hassan, mohamed ibrahim, & hassali, ; hussain & mohamed ibrahim, ; hussain et al., d; mohamed ibrahim et al., ; osman, ahmed hassan, & mohamed ibrahim, ) . in addition, a few dispensing errors have been identified (lenjisa et al., ) . according to basak, arunkumar, and masilamani ( ) , community pharmacy services in india are quite problematic, and the pharmacy's role in healthcare remains unrecognized. these authors have called for reform to meet societal needs. a study in nigeria found that some community pharmacists often administer injections for customers-in some cases, without a prescription. the number of prescriptions that community pharmacists receive is low. they suffer from the limited availability of some resources, which has a serious impact on their practice (adje & oli, ) . a review of community pharmacy practices showed that, in some countries, pharmacy outlets were run by nonpharmacists; dispensing practices were unsatisfactory; drug sellers' level of knowledge regarding diseases and medicines was poor; medicines were used irrationally; pharmacies were not meeting the government's licensing requirements; medication storage conditions were improper; and customers could hardly meet with pharmacists (hussain, mohamed ibrahim, & babar, a , b , d hussain & mohamed ibrahim, ) . a study on over-the-counter (otc) counseling in brazil (halila, junior, otuki, & correr, ) concluded that even though the most important factors taken into account when counseling an otc medicine were drug's efficacy and adverse effects, but only few pharmacists knew the meaning of terms related to evidence-based health. poudel, subish, mishra, mohamed ibrahim, and jayasekera ( ) reported that unregistered fixed-dose combinations of pharmaceutical products (e.g., antimicrobial combinations, nonsteroidal antiinflammatory drug combinations, and antimotility combinations) have been found in nepali healthcare facilities, including drug outlets. regarding prescription behavior, even in rural areas of india, the proportion of brand name prescriptions was high (aravamuthan, arputhavanan, subramaniam, & chander, ) . other common prescription problems include the lack of information, illegible handwriting, and various errors (e.g., prescription errors, dispensing errors, and improper labeling related to particular standards or requirements) (hussain & mohamed ibrahim, ; syhakhang, stenson, wahlström, & tomson, ) . pharmacy hours vary: typically, some pharmacies are open for approximately h (e.g., in malaysia), while others offer -h services (e.g., in qatar). in some countries (e.g., nepal and sudan), pharmacy hours and operations can be affected by the availability of reliable electrical power supply. some countries do not have conveniently located pharmacy outlets, and customers might have to walk for hours to reach one. some pharmacies lack proper facilities (e.g., a private room for patient counseling), space, reference resources (e.g., drug information), and/or quality medication (e.g., substandard and counterfeit and irrational fixed-dose combinations); have a poor layout, impractically arranged products, and/or disorganization issues; and/or keep and sell expired or almost expired items. developing countries also suffer from an insufficient number of pharmacists. in addition, for economic reasons, pharmacists prefer to work or set up their pharmacies in urban areas rather than in rural areas (smith, (smith, , . in addition, some pharmacists are hard to find in pharmacies ("the invisible pharmacist"), and patients/customers have to rely on pharmacy assistants/technicians (amin & chewning, ) . most of the time, these staff have no proper professional qualifications and lack important skills and knowledge. even worse, some community pharmacists lack particular competencies and communication skills, have no or few business skills, and do not have up-to-date knowledge. in some cases, pharmacists do not comply with regulations (e.g., selling antibiotics or psychotropic drugs without a prescription), and they often fail to assume responsibility for pharmaceutical care. in the eyes of the consumers, community pharmacists are always regarded as businesspeople rather than as healthcare professionals. community pharmacists must strike a balance between professional and business responsibilities. having both qualities, i.e., having a high level of professionalism and an excellent business sense, should not be so difficult. how these two aspects influence the health and well-being of individuals and society is what matters. the services provided by community pharmacists have been reported to focus more on their distributive function (e.g., basic medication dispensing and sales), not the expected proper medication dispensing practice mentioned above (wiedenmayer et al., ) . most of the time, pharmacists provide no advice/counseling; rarely interact with patients and physicians; make no referrals; lack or have few medicines due to poor planning and estimation/quantification; have no records of patients/clients or the medicines dispensed; use little to no technology; mix and prepare medications in the pharmacy rather than according to standards, for example, us or british pharmacopeia (compounding or extemporaneous dispensing); and do not provide drug information that could help reduce medication misadventures. in , the malaysian pharmaceutical society introduced its benchmarking guidelines for community pharmacies. the society sought to raise the standards of practice. unfortunately, a study reported that the level of awareness of these guidelines was low and that only around % of the pharmacies complied with them (siang, kee, gee, richard, & see hui, ) . the quality of the pharmacy education system has been affected. some countries lack colleges with pharmacy degrees. even if adequate, these colleges often lack quality curricula; the syllabi are out of date and do not cater to the present needs of the healthcare system. in addition, colleges lack staff; even if they have enough staff, they lack quality staff/faculty with appropriate qualifications or expertise. the pharmacy workforce is not carefully planned according to the country's needs. some countries do not have pharmacy associations, which could provide professional leadership, and some even are unable to provide continuing education for pharmacy staff. another critical problem is that there are very few policy makers and regulators who understand the system, who are committed and motivated, and who have sufficient technical know-how to solve the problems. in addition, many countries have a corrupt system and authorities; a weak and unstable government and economy; problems with bureaucracy, middlemen, profits, etc. that affect the final retail price, potentially making it too high for consumers; no or few effective price containment strategies/polices, which have resulted in unaffordable prices (khatib et al., ) , especially for the poor and others in need. due to the lack of an attractive salary and benefits, pharmacists have migrated to other countries for better life and career opportunities. as such, nonpharmacists are allowed to own and operate pharmacies in developing countries. the image of the pharmacist and the profession very much depends on customer satisfaction. a study conducted in nigeria showed that customers experienced moderate service satisfaction. customers were mostly dissatisfied with healthcare services that related to pharmaceutical care activities (oparah & kikanme, ) . in a patient satisfaction survey conducted in the united arab emirates (uae), scores were significantly lower than published data, suggesting that patients' expectations of community pharmacy services have not been met there (hasan et al., ) . dhote, mahajan, and mishra ( ) mentioned that the rise of pharmaceutical care services must be accelerated based on the rapid changes in consumers' expectations. best practices can be adopted and adapted according to a country's needs and conditions. does "one size" really fit all? is "comparing apples and oranges" difficult? adopting % of one country's practices in another country is unwise. many factors need to be considered. no country has a perfect system; however, community pharmacists in developing countries can definitely learn from at least one practice or service. according to brodie ( ) , the traditional role of dispensing medications has been expanded. pharmacists should be both health generalists and health specialists, which will have an impact on public health. even the american public health association ( ) supports the pharmacists' role in public health. should community pharmacists move beyond their traditional role? even when dispensing medicines through paper-based prescription services, pharmacists should comply with some fundamental standards. safety issues must be considered when dispensing medications. the pharmacy board of australia published guidelines for medication dispensing (i.e., guidelines for scanned and faxed prescriptions and steps to take when handling internet or mail-order dispensing); guidelines for dispensing extemporaneous medications; guidelines when handling errors (e.g., dispensing errors); guidelines for appropriate medication labeling; guidelines for patient counseling, privacy, and confidentiality; and pharmacy technicians' functions, responsibilities, and competencies (pharmacy board of australia, n.d.). in addition, for pharmacies that use electronic and computer systems, the royal pharmaceutical society of great britain (n.d.) has provided several guidelines and principles for good dispensing and appropriate dispensing procedures (e.g., professional checking, medication substitution, and labeling). malaysia, a developing country, has also developed guide to good dispensing practice (malaysian pharmaceutical services division, ) . these guidelines aim to have both public and private facilities dispensing medications according to the law and guidelines, which may ensure that patients receive the correct medications, adherence is improved, adverse effects are minimized, and errors are avoided. the document's contents relate to processing prescriptions, preparing medications, labeling, recoding, and issuing medications to the patient. in geographical areas where no pharmacists are available, a guide about managing medicines would be a handy document indeed (andersson & snell, ) . in some countries, community pharmacists are ready to provide extended services (or cognitive pharmaceutical services). according to cipolle, strand, and morley ( ) , cognitive pharmaceutical services entail the pharmacist's use of specialized knowledge to help patients or health professionals and promote effective and safe drug therapy. these services are simply "clinically oriented activities intended to improve medication prescribing and use" (farris, kumbera, halterman, & fang, ) . why are pharmacy practices still outdated in some countries? what are the barriers to quality community pharmacy services? are pharmacists reluctant to move forward? the lack of time, reimbursement, recognition, cooperation with general practitioners, documentation, networking; the location of services within the pharmacy premises; the attitudes of customers and pharmacists; the pharmacy owner's involvement (or lack thereof); the daily organization of services; and customer recruitment for such services are among the barriers to the successful implementation of extended services (cognitive services) (garrett & martin, ; gastelurrutia et al., ; hopp, sørensen, herborg, & roberts, ; rossing, hansen, & krass, ) . in some countries, pharmacists have moved away from product-oriented services toward service-oriented and then patient-oriented services, increasingly emphasizing the patient's health outcomes (the economic, clinical, and humanistic outcomes model) (drabinski, ; kozma, reeder, & schulz, ) . outcomes refer to the consequences (results) of interventions that are made to achieve therapeutic goals. outcomes can have economic, social/behavioral, or physiological characteristics. when community pharmacists are serving the public, in addition to health outcomes, at least four important parameters should be monitored: accessibility, availability, affordability, and acceptability. when patients benefit from the medications that they take, their health improves, which ultimately reduces costs (wiedenmayer et al., ) . the scope of pharmacy practice now includes patient-centered care-with all the cognitive functions of counseling, providing drug information, and monitoring drug therapy-and the technical aspects of pharmaceutical services, including medication supply management, as well as people-or public-centered care. community pharmacies can offer comprehensive healthcare services, including advanced and enhanced services. such services include the rational use of medicines; medication adherence; self-management clinics for group of patients with chronic diseases (e.g., diabetes mellitus, hypertension, and asthma); medication therapy management; screening and monitoring; education for enhancing medication adherence; encouraging and educating patients to receive their recommended immunizations and those for infants; home healthcare services; partnership in palliative care teams; drive-through facilities; mail and internet orders of medicines; rural and remote area services; mobile pharmacy; helping patients with special needs; public health and primary healthcare services (e.g., hiv/aids and drug abuse treatment); distributing literature and educating regarding life style change for stress reduction, proper nutrition, and exercising; collaboration with other healthcare professionals during disease outbreaks (e.g., ebola virus disease, severe acute respiratory syndrome, middle-east respiratory syndrome, and zika virus disease); involvement in an unwanted medicines program; health promotion (the process of enabling people to increase their control over-and to improve-their health, e.g., smoking cessation, obesity management, and diabetic self-management); drug therapy problems (defined as "[a]n undesirable event, a patient experience that involves, or is suspected to involve drug therapy, and that actually or potentially, interferes with a desired patient outcome" (cipolle et al., ; strand, cipolle, morley, ramsey, & lamsam, ) ); and pharmaceutical public health services. pharmaceutical public health has been defined as follows: the application of pharmaceutical knowledge, skills and resources to the science and art of preventing disease, prolonging life, promoting, protecting and improving health for all through the organized efforts of society. pharmacists could also provide public services, such as local guidelines and treatment protocols, medication use review and evaluation, national medicine policies and essential medicine lists, pharmacovigilance, needs assessment, and pharmacoepidemiology (wiedenmayer et al., ) . pharmacists should be at the front line to promote safe sex, birth control education, advice on nursing babies, and caring for elderly parents and relatives. in addition, pharmacists could work with local authorities in the direction of a cleaner and safer environment (air, water, and ground) and for safe food handling. pharmacists should only carry in stock and sell products with proven medical value, not selling tobacco products, and not supplements and homeopathic medicines that have no clear scientific evidence of safety and effectiveness. the literature has shown that community pharmacists in some countries have had a positive impact on public health. first, training and education programs have been able to enhance the knowledge and practices of pharmacists. continuing education programs, especially if mandatory, also play a significant role. second, pharmacy colleges have improved by incorporating relevant courses and topics into the syllabi for undergraduate pharmacy programs. third, strong, motivated, and uncorrupted pharmacy authorities/regulatory agencies have been able to improve community pharmacy practices because of their concern, motivation, and effort to make necessary improvements. to progress and gain society's acceptance, community pharmacists must acknowledge the following challenges in healthcare systems: � one-third of the world's population is known to lack regular access to essential medicines. for many people, the cost of medication is a major constraint. those hardest hit are patients in developing and transitional economies, where % to % of medicines are out-of-pocket expenses (who, ) . the burden falls most heavily on the poor, who are not adequately protected by current policies or by health insurance. � healthcare workers, including community pharmacist, are in short supply, especially in lmics (who, ) . � some countries are eager to introduce and establish a doctor of pharmacy (pharmd) degree in pharmacy colleges, but due to several reasons, they have failed to produce competent graduates who can apply clinical knowledge in practice or who can distance the practice from its traditional role. � the logistical aspects of distribution, often seen as the pharmacist's traditional role (i.e., the "count and pour, lick and stick pharmacy"), represent another challenge. � in terms of medication quality, studied medication samples have failed quality control tests (msh, ) , and substandard and counterfeit medications are highly likely to be on pharmacy shelves. � another major challenge is ensuring that medicines are used as advised or instructed; more than half of all prescriptions are incorrect, and more than half of the people who are prescribed with medications fail to take them correctly. medication adherence can be affected if the medication is unavailable or unaffordable or if the instructions given are not understood or remembered. furthermore, a patient's confidence or trust in the pharmacist or the medications prescribed may also affect adherence. � especially in economically deprived communities, self-medication with either modern or traditional medicines is becoming common practice. individuals resort to self-medication when healthcare services become more unaffordable and inaccessible (hughes, mcelnay, & fleming, ) . the situation deteriorates when prescription medicines can be easily obtained over the counter. community pharmacists could play a role in mitigating the risks of selfmedication (bennadi, ) . given the list of pharmacist-, pharmacy-, and practice-related issues above, are pharmacists still needed in the community and in the healthcare system? if community pharmacists still perform the basic function of medication dispensing or if a country lacks pharmacists, could we simply have medicine vending machines (i.e., a self-service technology) across the country (adams, ; poulter, ) ? these machines could provide customers access to otc drugs, nondrug items, and information, thereby supporting the self-care concept (steinfirst, cowell, presley, & reifler, ) . this technology could be argued to have an adverse effect on customers. for example, the buying and selling process lacks the "human touch," or customers leave the pharmacy without information or take medication incorrectly due to a lack of quality information. however, what is the difference when the same customers visit pharmacies with "invisible pharmacists"? do pharmacists just count pills? if community pharmacists are hesitant or refuse to change, these vending machines will put them out of business. for countries searching for cost-cutting strategies, this technology might be a solution. to be effective healthcare team members, community pharmacists need skills and abilities that will enable them to assume many different functions. who introduced the concept of the "seven/eight-star pharmacist," which the international pharmaceutical federation (fip) adopted in in its policy statement on good pharmacy education practice to outline the caregiver, decision-maker, communicator, manager, lifelong learner, teacher, and leader roles of the pharmacist. the pharmacist's function as a researcher has since evolved, and all these roles have been addressed in the competence standards (who, , pp. - ) . community pharmacists have to make efforts to move from being drug compounders and dispensers to being pharmaceutical care providers and medication experts; their role and function should focus on patient-centered care rather than products and profits. community pharmacists must equip themselves with adequate knowledge and skills and be responsible for ensuring that, irrespective of the medications provided and used, quality products are selected, procured, stored, distributed, dispensed, and administered to enhance patients' health and do them no harm. relevant pharmacy authorities should provide more support, training, and development for community pharmacies to help their pharmacists deliver high-quality services. pharmacy associations could organize programs in collaboration with pharmacy colleges and could involve regional or international experts if affordable. nonprofit international organizations, such as who and management sciences for health (msh), could assist lmics in this matter. in addition, some chain pharmacies could implement monthly programs. community pharmacists must be involved in cpd; individual pharmacists are responsible for the systematic maintenance, development, and broadening of their knowledge, skills, and attitudes to ensure their continued competence as professionals throughout their careers. community pharmacists (with the help of academics from pharmacy colleges, if required) must conduct research to document outcomes and impacts (e.g., accessibility, effectiveness, and positive perceptions of the experience); research must be conducted to assess the minimum standards and quality of community pharmacies and to provide evidence-based practice information. the numbers of published studies from developing countries are very low compared with those from developed countries. managerial and educational interventions are needed to improve the practice. community pharmacists could obtain inputs/ideas and explore the perceptions of community pharmacy staff-in addition to customers and patients-regarding aspects of service quality. these inputs could then perhaps be used to improve the services offered to customers. some pharmacists are able to use information technology to enhance pharmacy and pharmaceutical services; pharmacists in some other countries find doing it so problematic-due to a very basic infrastructure or the lack of basic competencies, among others. finally, who (wiedenmayer et al., ) and other sources have provided a guide and systematic approach for delivering pharmacy patient-centered care and good pharmacy and dispensing practice. public health pharmacy interventions, patient-centered care, rational medication use, and effective medication supply management are key components of an accessible, sustainable, affordable, and equitable healthcare system that ensures the efficacy, safety, and quality of medications. the customer's (patient's) expectations are rapidly changing; customers are becoming more aware of their healthcare needs. customers now demand better quality care and more attention to maintain or improve their overall health. evidence has shown that challenges and gaps exist in community pharmacy practice. in developing countries, the functions of community pharmacists must be redefined and reoriented. a paradigm shift in the mind-set and practices of pharmacists is urgently needed. • although the overall level of community pharmacy services provided in developing countries does not meet the public's expectations, gradual progress has been observed. • the number of trained community pharmacists is inadequate; their distribution is unbalanced; and, in some countries, individuals without the professional pharmacy degrees are allowed to work in pharmacies. thus, pharmacy authorities, policy makers, and educators must collaborate to fix these problems and make improvements. • due to the high prevalence of chronic diseases and the need to improve public health and wellbeing, community pharmacists must continue to be competent in their professional and business roles; pharmacists should expand the role in delivering wellness services (e.g., disease-oriented pharmaceutical care) that go beyond filling prescriptions. • many developing nations do not have effective and efficient regulations, guidelines, policies, governmental support, or electronic patient records and databases in community pharmacies to help establish and implement clinical, cognitive, and extended pharmacy services. • community pharmacists should establish benchmark best practices-at the very least among countries with similar economies and levels of development. role of a pharmacist 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cognitive pharmaceutical services (cps) in professionally active pharmacies benefits and risks of self-medication management of diarrhoea cases by community pharmacies in cities of pakistan using the potentials of community pharmacies to promote rational drug use in pakistan: an opportunity exists or lost medication counselling and dispensing practices at community pharmacies: a comparative cross sectional study from pakistan assessment of disease management of acute respiratory tract infection at community pharmacies through simulated visits in pakistan compliance with legal requirements at community pharmacies: a cross sectional study from pakistan availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the pure study data economic, clinical, and humanistic outcomes: a planning model for pharmacoeconomic research analysis of dispensing practices at community pharmacy settings in ambo town chapter quality assurance for pharmaceuticals strengthening pharmacy practice in vietnam: findings of a training intervention study how do community pharmacists in qatar respond to patients presenting with symptoms of acute respiratory tract infections evaluating community pharmacy practice in qatar using simulated patient method: acute gastroenteritis management consumer satisfaction with community pharmacies in are sudanese community pharmacists capable to prescribe and demonstrate asthma inhaler devices to patrons? a mystery patient study pharmacy board of australia. guidelines for dispensing of medicines prevalence of fixed dose drug combinations in nepal: a preliminary study medicine vending machines that dispense prescriptions hours a day go on trial barriers and facilitators in pharmaceutical care: perceptions and experiences among danish community pharmacies practice guidance: good dispensing guidelines -england community pharmacy role/service definition grid implementation of the benchmarking guidelines on community pharmacies in malaysia pharmacy practice community pharmacy in ghana: enhancing the contribution to primary health care vending machines and the self-care concept drug-related problems: their structure and function the quality of public and private pharmacy practices. a cross sectional study in the savannakhet province, lao pdr policy statements adopted by the governing council. the role of the pharmacist in public health pharmaceutical care in community pharmacies: practice and research in estonia pharmaceutical public health: the end of pharmaceutical care? jointly sponsored by the world health organization and the united nations children's fund. geneva: world health organization health reform and drug financing, selected topics, health economics and drugs, dap series no who global strategy on people-centred and integrated health services the role of the pharmacist in the health-care system -preparing the future pharmacist: curricular development people at the centre of health care: harmonizing mind and body, people and systems constitution of the world health organization. geneva: world health organization global strategy on human resources for health: workforce health promotion: a discussion document on the concept and principles: summary report of the working group on concept and principles of health promotion developing pharmacy practice: a focus on patient care. who (and fip) the untilled field of public health. modern medicine, , . who. the world health organization quality of life assessment (whoqol): position paper from the world health organization further reading chapter : comparative analysis and conclusion key: cord- -dvlb tw authors: abu, thelma zulfawu; elliott, susan j. title: when it is not measured, how then will it be planned for? wash a critical indicator for universal health coverage in kenya date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: dvlb tw the quality and safety of healthcare facility (hcf) services are critical to achieving universal health coverage (uhc) and yet the who/unicef joint monitoring program for water supply, sanitation and hygiene report indicates that only % and % of hcf in sub-saharan africa have basic access to water and sanitation, respectively. global commitments on improving access to water, sanitation, hygiene, waste management and environmental cleaning (wash) in hcf as part of implementing uhc have surged since . guided by political ecology of health theory, we explored the country level commitment to ensuring access to wash in hcfs as part of piloting uhc in kisumu, kenya. through content analysis, relevant policy documents were systematically reviewed using nvivo. none of the national documents mentioned all the component of wash in healthcare facilities. furthermore, these wash components are not measured as part of the universal health coverage pilot. comprehensively incorporating wash measurement and monitoring in hcfs in the context of uhc policies creates a foundation for achieving sdg . accessing quality health services is a challenge, especially in the global south. lack of access to water, sanitation, hygiene, waste management and environment cleaning (wash) undermine the quality of services provided in healthcare facilities [ , ] . the absence or inadequacy of safe wash in healthcare facilities compromises infection prevention and control, patient safety and child and maternal health [ ] . meanwhile, the who/unicef joint monitoring program for water supply, sanitation and hygiene reported that in sub-saharan africa (ssa), only percent of healthcare facilities have access to basic water services and percent have access to basic sanitation services. forty-one percent of healthcare facilities have basic waste management services. data on hygiene and environmental cleaning in healthcare facilities were inconclusive due to inadequate monitoring [ ] . similarly, cronk and bartram [ ] evaluated the environmental conditions of healthcare facilities in low-and middle-income countries (lmics) and found that only two percent of the healthcare facilities provided water, sanitation, hygiene and waste management services. also, ensuring access to wash in healthcare facilities extends beyond disease control to issues of dignity and respect. for example, women after childbirth in healthcare facilities require a clean bathroom with running water to maintain their personal hygiene. kohler, renggli, & lüthi [ ] in a comparative study in india and uganda sought to address the gender gap in access to wash in healthcare facilities. they undertook a needs assessment in hygiene and sanitation issues during menstruation and childbirth among women in selected maternal ward and inpatient facilities which were run by government. wash in healthcare facilities were assessed based on hygiene and health, security and safety, privacy, accessibility, comfort and menstrual hygiene management. from their study, lack of safe wash infrastructure and menstrual hygiene facilities were a burden for women in both countries. in addition, gon et al. in engaged in a study to investigate the status of water and sanitation in relation to childbirth in healthcare facilities and homes. from their study, less than percent of all delivery facilities and homes had access to wash in all countries [ ] . for example, in kenya, percent of women delivered with improved access to water and sanitation. furthermore, climate change and variability and conflicts burden the functioning of wash in healthcare facilities. first, percent of disasters in ssa, especially the horn of africa, are water-related [ ] . prolonged drought and floods have affected the quantity and quality of water available [ , ] . second, displaced people face wash related challenges and these events increase health risks and disease outbreaks such as cholera [ , ] . prior global commitments on ensuring access to wash were concentrated at the household level to the neglect of institutions. the widespread effects of ebola in even in healthcare facilities leading to the loss of several healthcare workers [ ] [ ] [ ] and the subsequent world health organization assessment on wash in healthcare facilities in initiated discussions and led to several global commitments to address this challenge of infection prevention and control in healthcare facilities. at the global stage currently, significant efforts towards ensuring access to wash have included and prioritized public spaces such as healthcare facilities. this is included in the sustainable development goals (sdg). goal seeks to ensure access to water and sanitation. targets . and . of the sdgs highlight the need to expand wash monitoring by relevant stakeholders in non-household settings, such as healthcare facilities. similarly, goal seeks to ensure healthy lives and promote wellbeing for all at all ages. target . highlights achieving universal health coverage which does not just incorporate reducing the financial burden of people, but further ensuring quality essential healthcare services for all. similarly, in , world leaders adopted the sendai framework for disaster risk reduction (drr) and one of its targets is to substantially reduce disaster damage to critical infrastructure and disruption of basic services, among them health facilities through developing their resilience by [ ] . this framework was a paradigm shift from managing disasters to disaster risk reduction. achieving this target means ensuring the effectiveness and efficiency of all the components of a health system, including wash. in march , as part of the launch of international decade for action "water for sustainable development - ", the un secretary general also made a global call to action for wash in all healthcare facilities [ ] . in response, various ministers of state signed the world health assembly resolution on wash in healthcare facilities as part of the implementation of universal health coverage scheme. in addition, various assessment tools, healthcare facility guidelines and frameworks on wash were published by the global community especially world health organization. however, it is evident from research that socially and institutionally driven challenges such as lack of data and knowledge are major hindrances to improved service provision such as healthcare in ssa [ , , ] . for instance, adjei, sambu & smiley [ ] explored historical and emerging policies and institutional arrangements surrounding urban water supply in sub-saharan africa. the persistent lack of water in urban areas was attributed to weak institutional arrangements and poor enforcement of legislations. the authors recommended the need for institutional rectification to achieve the sustainable development goals by . similarly, maina et al. [ ] in their study on the role of wash on antimicrobial resistance in healthcare facilities in kenya highlighted the need for government institutional support for healthcare managers to enable them achieve access to basic wash in healthcare facilities. it is evident from research that the availability and enforcement of regulations such as policies and legislations on an agenda enhance their achievement [ ] . guo & bartram [ ] in their investigation on the predictors for water quality in rural healthcare facilities concluded that the presence of a protocol for operation and management in a facility was associated with safe water use. following this, there is little research to understand the implementation process or the institutional arrangements of wash in healthcare facilities and the influence of global commitments on country level policy environment on ensuring access to wash in health facilities in ssa. therefore, this paper reviews the framing of wash in healthcare facilities in relevant global and country-level institutional documents (policies, legislations, guides, plans and monitoring tools) using kenya as a case study. following the introduction, the second section explores the theoretical framing of this paper, the political ecology of health theory. the third section explores the study context, kenya. the fourth section indicates the methods of data collection and analyses. the presentation of the results and discussion make up the fifth and sixth sections, respectively. the seventh section concludes the paper with a summary of the key points and emphasizing the relevance of wash in healthcare facilities to sdg and sdg . social theories provide a more comprehensive connection between determinants and processes of health and wellbeing [ ] [ ] [ ] . the paper is guided by political ecology of health theory, which explores how power, politics, structures, agendas and/or agents shape the environment and health risks of populations [ , ] . this theory further explores how growing discourse on health at the global scale influence and shape local contexts such as policies development and implementation. the prioritization, implementation and management of wash interventions are political and power-laden at the global, national and local levels [ ] . this theory has been useful in the study of prioritization and implementation of development projects and health and wellbeing of local populations [ ] [ ] [ ] . it has also guided studies in healthcare services in lmics [ ] and privatization of water and its impacts on health and wellbeing [ ] . kenya is an east african country with an estimated population of about million [ ] . the country has counties. according to the kenyan health policy - , kenya has an agenda to implement universal health coverage and achieve countrywide coverage by . in , the universal health coverage scheme was launched and currently piloted in four counties, kisumu, isiolo, machakos and nyeri. a policy brief written by wangia & kandie [ ] and published by the ministry of health with a focus on quality of care and essential elements in attaining universal health coverage in kenya indicated the need for appropriate water and sanitation infrastructure in healthcare facilities. according to the who/unicef joint monitoring program for water supply, sanitation and hygiene report based on data, only % of healthcare facilities in kenya had access to basic water services. this served a population of , , people. healthcare facilities with limited and no water services were . percent and . percent, respectively. concerning sanitation in healthcare facilities, monitoring and data collection was inadequate. eighty-six percent of healthcare facilities had insufficient data and percent of healthcare facilities recorded no sanitation services. regarding hygiene, insufficient data for . percent of healthcare facilities was recorded. in addition, . percent of the healthcare facilities recorded no hygiene services. only . percent of healthcare facilities recorded basic waste management services, . percent recorded limited services and . percent reported no waste management services. for environmental cleaning in healthcare facilities data were insufficient for comprehensive and conclusive analysis. from these data it is evident that access, regular monitoring and evaluation of wash in healthcare facilities are major challenges. other researchers such as bennett, otieno, ayers, & odhiambo [ ] , essendi et al. [ ] and maina et al. [ ] have reported lack of wash in healthcare facilities in kenya in their studies. in addition, at the community level, residents questioned the quality of healthcare delivery in hospitals without the appropriate wash infrastructure [ , ] . according to wangia & kandie [ ] , quality care is not yet a legal requirement and issues such as poor enforcement of legislation and minimal information on quality of care especially in private facilities will negatively impact achieving universal health coverage. other key challenge to accessing wash in healthcare facilities are climate variability and civil disruptions. the amount of rainfall affects the quantity and quality of water available for use in most marginalized communities. the struggle to access safe water is worsened in the face of climate variability. floods from torrential rains and effects of drought from prolonged dry seasons have displaced many citizens, especially in rural and marginalized areas. as of september , about . million kenyan citizens were in need due to several episodes of drought [ ] . kenya has also recorded an increasing influx of migrants from neighboring countries greatly affected by drought. these people are further exposed to health hazards subsequently increase attendance at healthcare facilities. kenya has a partial plan to support ensuring access to wash in health care facilities [ ] . despite progress and new initiatives, more needs to be done to understand and solve the challenge of lack of wash in healthcare facilities. qualitative content analysis was used to analyze the framing of wash in healthcare facilities in relevant documents for this paper. relevant wash in healthcare facility documents such as policies, legislations, guidelines, plans and monitoring tools were gathered for this research from may to june . documents included in this research were accessed using two methods. first, desktop searches were conducted to identify and access current and operational wash in healthcare facility documents. desktop searches on key phrases like "wash in healthcare facilities", "quality care" and "universal health coverage" were done using google and google scholar. the websites of the ministry of health, kenya, world health organization, who/unicef joint monitoring program for water supply, sanitation and hygiene as well as the official website for wash in healthcare facilities were searched for relevant documents. second, the ministry of health, kisumu county office, kenya was contacted in person by researchers from june -september for relevant documents on wash in healthcare facilities. current operational documents guiding the implementation and monitoring of wash in healthcare facilities, quality healthcare and the piloted universal health coverage as of september were sought at the ministry. documents included in this study were based on three criteria after been carefully screened. first documents comprehensively indicated wash in healthcare facilities or/and health care (quality care and universal health coverage) as their focus. second, current and operational national documents with an agenda on wash in healthcare facilities, quality care in healthcare facilities and universal health coverage were also considered. third, document was listed by relevant key stakeholders identified and interviewed at the ministry of health, kisumu county office. the documents included in this study were published from to . documents prior to when the upsurge in campaigns for wash in hcfs and uhc were included because they set the foundation for drafting current wash in hcf guidelines and policies. table shows a list of relevant documents included in this research. first, the documents were categorized based on scale-global and national. second, based on the purpose of the document-legislation, policy, guidelines, monitoring tool and plans. in total, documents were included, five ( ) global level documents and eight ( ) national level documents regulating issues of wash in healthcare facilities. two of the twelve national documents are county level documents. kenya has a decentralized government system and the counties have the power to contextualize national policies or develop policies that meet their needs. a coding frame (table ) was developed to guide the coding process. the frame was guided by the logic framework (input, activities, output and impact), heuristic framework (agenda setting, formulation, implementation and evaluation) [ ] and policy triangle (grounded in a political economy perspective and considers actors, context, process and content shape policymaking) [ ] . the authors adapted the washfit conceptual framework [ , ] . it is a framework designed to help implementers identify risks in healthcare facilities and it provides practical tools and templates for managing wash and facilities. themes developed for coding were first guided by the water-health nexus. cook & bakker [ ] define water security as "sustainable access on a watershed basis to adequate quantities of water, of acceptable quality, to ensure human and ecosystem health". this definition embodies two sdgs, sdg -good health and wellbeing, of particular interest to this research is target . (achieve universal health coverage, including financial risk protection, access to quality essential healthcare services and access to safe, effective, quality and affordable essential medicines and vaccines for all) and sdg , clean water and sanitation for all. in addition, the key components of wash-water, sanitation, hygiene, waste management and environmental cleaning were adapted from the who/unicef joint monitoring program for water supply, sanitation and hygiene. key indicators for monitoring wash in healthcare facilities and categorized as improved, basic, limited and no service [ ] . guided by this coding frame, a coding schedule (tables - ) was developed for coding. content analysis was done deductively using nvivo . key phrases like wash in healthcare facilities, universal health coverage, wash in healthcare facility stakeholders and quality care were coded. this research explored the framing of wash in healthcare facilities in relevant global and national policies, guidelines, monitoring tools and legislations. from the content analysis, five ( ) global documents comprehensively mentioned wash in healthcare facilities. two national level documents mentioned water, sanitation and hygiene in phrases or sentences while environmental cleaning and waste management were excluded. "the core indicators define "basic" service levels for water, sanitation, hygiene, health care waste management and environmental cleaning in health care facilities" (core questions and indicators for monitoring wash in health care facilities in the sustainable development goals) the need to ensuring access to water, sanitation and hygiene in health care facilities was mentioned: "ensure that all new health facilities are appropriately designed and constructed with reliable water supply and environmental sanitation and hygiene facilities, including toilet and hand-washing facilities, taking into account gender, age and disability considerations" (kenya environmental sanitation and hygiene policy - ). "facility design and planning should ensure the following: adequate supply of safe water, adequate floor space for beds, adequate space between beds, adequate hand-washing facilities, adequate sanitary facilities" (national infection prevention and control guidelines for health care services in kenya, ). the global documents serve as a guide for national wash in healthcare facility implementation. they also specify the core areas of wash in healthcare facilities that need facility managers and implementers attention: "to develop and implement a road map according to national context so that every healthcare facility in every setting has, commensurate with its needs: safely managed and reliable water supplies; sufficient, safely managed and accessible toilets or latrines for patients, caregivers and staff of all sexes, ages and abilities; appropriate core components of infection prevention and control programmes, including good hand hygiene infrastructure and practices; routine, effective cleaning; safe waste management systems, including those for excreta and medical waste disposal; and, whenever possible, sustainable and clean energy" (a _r wash in healthcare facilities resolutions). the global wash in healthcare facilities documents also set a monitoring standard for countries given in-country monitoring indicators on wash in healthcare facilities are often not comprehensive: "in support of sdg monitoring and to allow for comparable data to be generated within and between countries, a core set of harmonized indicators and questions that address basic wash services in health care facilities that will be applicable in all contexts is needed" (core questions for monitoring wash in healthcare facilities in the sustainable development goals). the individual components of wash were highlighted in the documents assessed. the various components are outlined below. recommended water sources for healthcare facilities include piped water, boreholes or tube wells, protected dug wells, protected springs, rainwater and packaged or delivered water. the theme water in healthcare facilities was mentioned in nine ( ) documents of which four were national documents. some documents highlighted the need for water in healthcare facilities: "sufficient water-collection points and water-use facilities are available in the health center to allow convenient access to, and use of, water for drinking, food preparation, personal hygiene, medical activities, laundry and cleaning" (essential environmental health standards in healthcare). the types of water systems in healthcare facilities were also mentioned in some documents: "improved water sources in healthcare settings include piped water, boreholes/tube wells, protected wells, protected springs, rainwater and packaged or delivered water" (washfit, a practical guide for improving quality of care through wash in hcfs). at the national level, the water act mentions the provision of water in healthcare facilities: "nothing in this section prohibits-(a) the provision of water services by a person to his employees; or (b) the provision of water services on the premises of any hospital, factory, school, hotel, brewery, research station or institution to the occupants thereof, in cases where the source of supply of the water is lawfully under its control or where the water is supplied to it in bulk by a licensee" (water act cap ). recommended sanitation infrastructure includes flush/pour flush to piped sewer system, septic tanks or pit latrines; ventilated improved pit latrines, composting toilets or pit latrines with slabs. sanitation in healthcare facilities was highlighted in five ( ) global documents and three ( ) national documents. basic sanitation service was defined as follows: "basic sanitation services definition: proportion of health care facilities with improved and usable sanitation facilities, with at least one toilet dedicated for staff, at least one sex-separated toilet with menstrual hygiene facilities, and at least one toilet accessible for users with limited mobility" (core questions in monitoring wash in healthcare facilities in the sustainable development goals). the maintenance of sanitary infrastructure was highlighted. "ensuring houses, institutions, hospitals and other public places maintain environment to the highest level of sanitation attainable to prevent, reduce or eliminate environmental health risks" (kenya health act no. of ). hygiene infrastructure include sink with tap, water tank with tap, bucket with tap or similar device, alcohol based hand rub dispensers. hygiene in healthcare facilities was highlighted in eight documents analyzed. three ( ) national level documents and five ( ) global documents. hygiene was defined as: "basic hygiene services definition: proportion of health care facilities with functional hand hygiene facilities available at one or more points of care and within meters of toilets" (core questions for monitoring wash in healthcare facilities in the sustainable development goals). the importance of hygiene facilities was also highlighted in some documents, for example: "hand hygiene is the single most important ipc precaution and one of the most effective means to prevent transmission of pathogens associated with health care services. appropriate hand hygiene must be carried out upon arriving at and before leaving the health care facility, as well as in the following circumstances" (national infection prevention and control guidelines for health care services in kenya) waste management in healthcare facilities was highlighted in nine ( ) documents. different types of waste are generated from various sectors of the healthcare facility as a result waste segregation was highly illustrated in the documents: "the four major categories of health-care waste recommended for organizing segregation and separate storage, collection and disposal are: • sharps (needles, scalpels, etc.), which may be infectious or not • non-sharps infectious waste (anatomical waste, pathological waste, dressings, used syringes, used single-use gloves) • non-sharps non-infectious waste (paper, packaging, etc.) • hazardous waste (expired drugs, laboratory reagents, radioactive waste, insecticides, etc.)" (essential environmental health standards in healthcare). it is recommended colors and images be used to identify waste containers and waste should be appropriately disposed by incineration, autoclaving and burial in a lined, protected pit. the repercussions of improper healthcare waste management were mention. "review medical waste management guidelines for health care facilities to protect public health and safety, provide a safer working environment, minimize waste generation and environmental impacts of medical waste disposal and ensure compliance with legislative and regulatory requirements" (kenya environmental sanitation and hygiene policy - ). basic environmental cleaning in a healthcare facility was defined as: "definition: proportion of health care facilities which have protocols for cleaning, and staff with cleaning responsibilities have all received training on cleaning procedures" (core questions for monitoring wash in healthcare facilities in the sdg). "housekeeping refers to the general cleaning of hospitals and clinics, including the floors, walls, certain types of equipment, furniture, and other surfaces. cleaning entails removing dust, soil, and contaminants on environmental surfaces. cleaning helps eliminate microorganisms that could come in contact with patients, visitors, staff, and the community; and it ensures a clean and healthy hospital environment for patients and staff." (national infection and prevention and control guidelines for health care services, ) environmental cleaning is a major challenge due to financial constraints: "as a result, health facilities often lack funds for capital infrastructure investments and ongoing operation and maintenance as well as for overlooked functions such as cleaning and waste management" (wash in hcf, practical steps to achieving quality care). the constitution of kenya indicted the right to a clean environment by all citizens but does not specifically address healthcare facilities. "every person has the right to a clean and healthy environment, which includes the right-f(a) to have the environment protected for the benefit of present and future generations through legislative and other measures, particularly those contemplated in article " (kenya constitution). the importance of wash in connection to achieving sdg was highlighted in some of the documents: "noting that without sufficient and safe water, sanitation and hygiene services in health care facilities, countries will not achieve the targets set out in sustainable development goal " (a _r wash in healthcare facilities resolutions). specifically, the role of wash in healthcare facilities in achieving quality care as part of the implementing and achieving universal health coverage was mentioned. "in addition, wash in hcf is important for meeting several targets under sdg (health for all) and in particular target . on universal health coverage" (core questions for monitoring wash in healthcare facilities in the sustainable development goals). universal health coverage was framed to include both financial and quality care. "universal health coverage (uhc) means that all individuals and communities receive the health services they need without suffering financial hardship. it includes the full spectrum of essential, quality health services, from health promotion to prevention, treatment, rehabilitation, and palliative care" (wash in hcf, practical steps to achieving quality care). however, the national level documents did not mention universal health coverage in line with wash in healthcare facilities, but did associate uhc with quality care: "other projects include digitization of records and health information system; accelerating the process of equipping of health facilities including infrastructure development; human resources for health development; and initiating mechanisms towards universal health coverage" (kenya health policy - ). "the goal of devolution in health is to enhance equity in resource allocation and enhance access to essential services by accelerating universal health coverage (uhc) and improving quality service delivery for all kenyans, especially those who need it most" (planning, budgeting performing, review process guide for health sector). the national monitoring tool focused on the registration process of citizens for the uhc and the frequency of visits by patients to a healthcare facility: "what mechanisms are in place to identify those registered for uhc" (final uhc level and final supervision tool). access and functionality of wash in healthcare facilities were associated with infection control in healthcare facilities and beyond: "recalling wha . ( ) on the global action plan on antimicrobial resistance, which underscores the critical importance of safe water, sanitation and hygiene services in community and health care settings for better hygiene and infection prevention measures to limit the development and spread of antimicrobial-resistant infections and to limit the inappropriate use of antimicrobial medicines, ensuring good stewardship" (a _r wash in healthcare facilities resolutions). infection prevention and control in healthcare facilities was defined as: "infection prevention and control (ipc) is broadly defined as the scientific approaches and practical solutions designed to prevent harm caused by infection to patients and health workers associated with delivery of health care" (wash in hcf, practical steps to achieving quality care). kenya has a guide on healthcare infection prevention and prevention: "these guidelines are intended to provide administrators and hcws with the necessary information and procedures to implement ipc core activities effectively within their work environment in order to protect themselves and others from the transmission of infections" (national infection prevention and control guidelines for health care services in kenya, ). infection control in healthcare facilities was also associated with waste management: "strengthening infection prevention and control systems including health care waste management in all health facilities" (kenya health act. of ). wash, infection control and prevention were also associated with the safety of the public, patients, caregivers and healthcare workers: "every patient and every family member and facility staff who cares for them deserves a clean and safe health care environment with high quality water, sanitation, and hygiene services" (wash in hcf, practical steps to achieving quality care). aside focusing on the safety of all who visit health care facilities, some of the documents also highlighted the safety of healthcare workers: "strategies to protect health workers include the following: implementing standard precautions, immunizing all health workers against hbv, especially those working in health care settings, providing ppe, managing exposures in a timely manner, eliminating unnecessary sharps and injections successful implementation of these strategies requires an effective quality improvement or infection prevention and control committee (ipcc) with support from the hospital management team" (national infection prevention and control guidelines for health care services in kenya). some national documents highlight the provision of safe healthcare facilities, but did not link safety to wash nor explain what a safe working environment entail: "the right to a safe working environment that minimizes the risk of disease transmission and injury or damage to the health care personnel or to their clients, families or property" (kenya health act no. of ). the functionality of wash in healthcare facilities is impacted by climate change or weather patterns or civil disruptions. in the context of the national documents, the increased burden on healthcare facilities was highlighted: "political instability in the eastern africa region and the subsequent in-migration of refugees into kenya has the result of increasing the demand for health services in the country and raising the risk of spreading communicable diseases" (kenya health policy - ). the need to appropriately site infrastructure was mentioned: "the site should have proper drainage, be located downhill from any wells, free of standing water, and not be in a flood-prone area. the site should not be located on land that will be used for agriculture or development" (national infection prevention and control guidelines for health care services in kenya). the impact of climate change was highlighted, but framed as a question in the washfit tool: "do seasonality and/or climate change affect wash services and are there plans in place to cope with this?" (washfit, a practical guide for improving quality of care through wash in hcfs). measures to reduce or eliminate the impact of climate change, civil disruptions and anthropogenic activities at the healthcare facility were mentioned: "buildings are designed and activities are organized so as to minimize the spread of contamination by the movement of patients, staff and careers, equipment, supplies and contaminated items, including healthcare waste, and to facilitate hygiene" (essential environmental health standards in healthcare). "care must be taken, when siting latrines, to avoid contaminating groundwater and risk of flooding" (essential environmental health standards in healthcare). the national documents mention ddr in light of the general public not specific to the healthcare and wash facilities. healthcare services are needed in times of disasters or disease outbreaks. the importance of wash in healthcare facilities as part of emergency preparedness was highlighted: "wash services strengthen the resilience of health care systems to prevent disease outbreaks, allow effective responses to emergencies (including natural disasters and outbreaks) and bring emergencies under control when they occur" (washfit, a practical guide for improving quality of care through wash in hcfs). the national monitoring tool mentioned emergency preparedness in terms of referral systems, functional emergency teams and the presence of ambulances for patient transportation to referral hospitals: "emergency preparedness and timely response in facility and referral. has there been any referral in the last one month? do you have a functional emergency response team?" (uhc level and final supervision tool). at the county level, the hospital preparedness did not include wash: hospital preparedness. infrastructure-numbers of hospitals with casualty departments, icu, bed capacity, morgue facilities. human resource-well trained cadres (basic life support, advanced cardiac life support.) contingency/response plan updated. disaster emergency kits, medicine stockpiles. community support-alternative treatment centers (health and nutrition sector contingency plan, ) wash in healthcare facilities stakeholders emerged in six ( ) documents. the implementation of wash in healthcare facilities is a multi-stakeholder activity. at the national level: "however, wash is not the responsibility of the ministry of health alone. ministries of water and sanitation are critical for improving municipal wash supplies and providing technical expertise to health care facilities. ministries of finance can provide important budget allocations and financing mechanisms. moreover, local governments have a responsibility to manage and fund wash at the local level. overall, coordination requires a high level of leadership beyond any one ministry to ensure a common, cohesive approach" (wash in hcf, practical steps to achieving quality care). specifically, quality health care services should be monitored: "the district health management team (dhmt) is responsible for monitoring the facilities within the district for using and complying with ipc practices. the dhmt is also responsible for ensuring that adequate and appropriate resources are available to support ipc practices within these facilities" (national infection prevention and control guidelines for health care services in kenya). other aspects of stakeholder engagement are training, monitoring and evaluation were mentioned. "prepare a budget that reflects aims and available resources, with potential to scale-up. the training budget should realistically consider all the costs, which include the actual training, but also the followup support that is required to assist facilities in ongoing challenges and improvements. in addition, it is useful to consider the funds for physical supplies as even providing some minor, immediate improvements (such as hand hygiene stations, low-cost water filtration or on-site chlorine generation) can help realize major improvements in reducing health risks and set the foundation for longer term improvements such as piped water" (washfit, a practical guide for improving quality of care through wash in hcfs). guided by the political ecology of health theory this paper explored the framing of wash in healthcare facilities in relevant policies, guidelines, legislation, plans, monitoring and evaluation documents at the global and national context using kenya as a case study. in these documents, wash in healthcare facilities was framed in relation to the importance of wash in a healthcare facility such as infection prevention and control, quality care and achieving universal health coverage. it was also framed in terms of infrastructure in healthcare facilities. from a political ecology of health perspective, the global agenda on wash in healthcare facilities influenced the growing concerns of wash in healthcare facilities at the national level in kenya. from this study, the global agenda on achieving the sustainable development goal and goal influenced political, social, economic and cultural factors in the implementation and use of wash in healthcare facilities in kenya. the global resolutions, guidelines and monitoring documents are guides for national level adaption. similarly, with respect to the influence of global campaigns on national agenda, asiki et al. [ ] established that the kenya national guidelines on cardiovascular diseases were guided by existing global initiatives and guidelines such as the tobacco control act. specifically, the global campaign on achieving universal health coverage led by the world health organization accelerated movements to implementing universal health coverage in kenya as stated in the kenya health policy ( - ). kenya is currently piloting universal health coverage in four counties. the acronym wash means water, sanitation, hygiene, waste management and environmental cleaning [ ] . from this research comprehensive mention of wash in healthcare facilities was dominant in global documents than national documents. two national documents mentioned water, sanitation and hygiene in sentences excluding environmental cleaning and waste management. other national documents mentioned one of these components. first, this could be associated with the fact that the global documents addressed wash in health care facilities specifically. none of the national documents were published specifically for wash in healthcare facilities. second, most of the national documents were published before the agenda for wash in healthcare facilities was initiated. in addition, the final monitoring tool for universal health coverage does not comprehensively measure access and functionality of water, sanitation, hygiene, waste management and environmental cleaning. it monitored aspects of water and hygiene. waste management, sanitation and hygiene are in the same category. for instance, the presence of a functional incinerator, a well-protected ash pit, a well-protected placenta pit and having a set of three color-coded bins in all wards and clinical departments and used for segregating waste at the point of generation are in the same category. at the time of data collection, a universal health coverage policy or agenda was not instituted. however, it was evident from the final universal health coverage monitoring tool for the kisumu county that efforts towards the implementation of universal health coverage were directed towards finance and registration of citizens than quality care. indicators for wash in healthcare facilities were not adequately presented and this could have impacts on the planning and financing of quality care when the universal health coverage program is fully rolled out in the country. similarly, maccord et al. [ ] highlighted the need for quality data collection on relevant wash in healthcare indicators to achieve environmental health policies in healthcare facilities in their research in malawi. in addition, inadequate or inconsistent data will complicate the assessment of interventions towards implementing universal health coverage [ ] . it was also evident that the previous healthcare facility monitoring tool, titled the integrated management supportive supervision tool measured more wash in healthcare indicators than the final universal healthcare monitoring tool measured. although this tool did not comprehensively cover all the aspects of wash, it touched on all five components of wash. for instance, the tool monitored separated toilets for staff and patients. wash in healthcare facilities cannot be achieved without the relevant key stakeholders at both the national and global levels. ensuring access to wash in healthcare facilities is complex and requires the efforts of different institutions. forming partnerships are very critical to achieving complex and connected challenges [ ] . the global documents such as the wash resolutions document listed some key institutions, ministry of health, water, finance and energy in achieving wash in healthcare. other relevant key stakeholders include communities where healthcare facilities are situated and nongovernmental organizations. wash in healthcare facilities was also framed in terms of stakeholder engagements such as trainings. training on wash management or infection control, budgeting of funds for implementing wash in healthcare services and monitoring and evaluations are some of the key roles of government and nongovernmental organizations mentioned in both the global and national documents. for instance, inadequate data collection has been associated with lack of technical knowledge on policy documents or monitoring tools by government officials [ ] . this barrier hinders advocating for the appropriate resources required for effectively implementing environmental health policies and plans by civil society groups and non-governmental organizations. maina et al. [ ] in their research on the role of wash in healthcare facilities in averting anti-microbial resistance in county level hospitals reported inadequate resource allocation by the government as a key challenge to accessing wash in healthcare facilities. similarly, guo & bartram [ ] reported that about a fifth of facilities overall countries they investigated as part of a study to explore predictors of water quality in rural healthcare facilities reported having an insufficient budget for supplies for water, sanitation and hygiene or infection control. resources or funding is a major requirement to implementing wash in healthcare facilities [ ] . anderson et al. [ ] in their paper expressed the need for wash in healthcare facility stakeholders to adequately monitor the quality, quantity, input and output of wash services in healthcare facilities to ensure effective costing when planning for water, sanitation, hygiene, waste management and environmental cleaning in a healthcare facility. it is also recommended that wash national documents in ssa should include relevant stakeholders such as the cleaners and maintenance officers since they directly deal with issues of wash in a healthcare facility [ ] . the importance of wash in healthcare facilities cannot be underestimated in terms of infection control and prevention and safety of facility users and workers. cleaning and disinfection of healthcare facilities prevent disease transfer and if not adequately handled weakens the healthcare system. similar to the ebola outbreak, the current covid- outbreak has compromised the quality of care in many healthcare facilities and a growing number of healthcare workers have died even in global north countries. however, wash is not listed as a requirement for hospital preparedness in the county level health and nutrition contingency plan. the issue of wash and safety of patients, caregivers and workers were dominant in global documents than the national documents. the national infection prevention and control guidelines for health care services in kenya clearly lays out the procedures, roles and responsibilities in infection prevention and control at the health care facility. other documents mentioned the need for ensuring a safe working environment for healthcare workers, but do not clearly define what a safe environment means. however, the previous monitoring tool for healthcare facilities monitored the presence of personal protective equipment such as the single use of aprons, goggles, gloves, fire extinguishers and fire exit. the safety and functionality of wash services in healthcare facilities were also framed in the context of natural disasters such as drought and floods. only the health act mentioned issues of wash in healthcare facilities in association with impacts of climate change. wash infrastructure and climate change is also framed as a caution to ensure wash infrastructure are efficient and can withstand and recover from the shocks of climate variability impacts. for instance, engaging in waste burial or burning in a flood prone area facilitates surface and ground water contamination. civil disruptions such as political instability burdens the functionality of healthcare facilities and wash infrastructure in two ways. the structures are often destroyed or the healthcare facilities are burdened with people seeking healthcare. however, these civil disruptions are not mentioned in the global documents in the context of wash in healthcare facilities. kenya has recorded several civil disruptions. of most significance is the post-election violence in . civil disruptions need to be considered in wash in healthcare facility planning, implementation and maintenance. this brings to question the framing of wash and disaster risk reduction in healthcare facilities. disaster risk reduction was framed as a recommendation to healthcare managers. the universal health coverage policy was not available at the time of this study, the authors only had access to the final universal health monitoring tool for level and level facilities. this is a limitation of this study since the authors could not comprehensively analyze the framing of quality care as part of the universal health coverage campaign in the country. however, access to the uhc final monitoring tool highlights the indicators of uhc being prioritized during the piloting phase. this phase is critical to the finalization of the uhc policy in the country. from a policy perspective, there is a need for the development of a national level wash in healthcare facility guideline which addresses contextual factors of kenya across all levels of the healthcare system. all relevant stakeholders should be engaged in the development of a comprehensive binding document on wash in healthcare facilities. this is necessary because research has closely associated the prevalence of disease and poor health management to the lapses in government policies in ghana than other countries [ ] . second, the final monitoring tool for universal health coverage needs to be revised to comprehensively measure water, sanitation, hygiene, environmental cleaning and waste management indicators in healthcare facilities using the global tools as guides. it will ensure effective data collection, planning and implementation of wash in hcf. for example, it is evident that integrating washfit training and supervision enhance quality service provision in healthcare facilities [ ] . similarly, researchers have contextualized some monitoring tools in wash in hcf research. maina et al. [ ] adapted and contextualized the washfit tool and developed washfast for the assessment of wash indicator performance in facilities beyond primary healthcare level. the authors developed a total of wash in healthcare indicators relevant to monitoring wash in hospitals in limited resource areas. in addition, there are existing monitoring tools which can be useful in monitoring wash in hcf indicators. patel et al. [ ] review on wash in healthcare monitoring tool developed from to july recommended the need for more comprehensive and concrete wash in health care monitoring tools. a recent assessment by the usaid and maternal child survival program on the kenyan health management information systems (hmis) indicated that half of hospitals surveyed used an electronic medical record that was not linked to the district health information software (dhis ) in [ ] . the hmis and the dhis could be instrumental in monitoring required wash indicators and quality services should relevant wash indicators be included. from this review, the district health management team (dhmt) is responsible for monitoring all activities in healthcare facilities. access, functionality, safety and availability of water, sanitation, hygiene, environmental cleaning and waste management indicators should be reviewed by the dhmt. effectively monitoring the indicators of wash in hcf will efficiently prepare facilities for disease outbreaks and disasters. in addition, it is evident that kenya has policies, plans and guidelines which when enforced can address the issues of quality healthcare facilities. for instance, the need to include wash infrastructure in healthcare facilities was published in the national infection prevention and control guidelines for healthcare services in kenya in . this is again emphasized in the kenya environmental and sanitation policy, published in . it is evident more needs to be done to ensure policies are fully implemented ( ) . commitment by all state officials, nongovernmental organizations and civil society groups are needed to achieve quality care in healthcare facilities. a review of reports on global meeting on wash in healthcare facilities: from resolution to revolution and the wash in health care facilities stakeholder commitments indicated varied levels of commitments. several partners such as non-governmental organizations and private institutions have made commitments to support kenya through global/national/local advocacy, technical support, implementation, research and learning [ ] . however, kenya government or country was not listed in the country level commitment section of the report published in [ ] . commitment and prioritization of wash in healthcare facilities by the country's institutions and leaders will accelerate achieving quality healthcare. issues of wash in healthcare facilities should gain equal prominence as issues of financing curative measures in healthcare facilities in the yet to be implemented uhc policy across the country by . in summary, accessing quality healthcare services is a challenge especially in marginalized areas. the lack of access to water, sanitation, hygiene, environmental cleaning and waste management in healthcare facilities affect the quality of care provided. from this research, relevant documents addressing issues of wash in healthcare facilities, quality health services and universal health coverage at the global and national levels framed wash in healthcare facilities in terms of its importance, like infection prevention and control and enhancing universal health coverage and types of infrastructure. factors such as climate change and civil disruptions that affect the access and use of wash in healthcare facilities were also highlighted and framed as precautions to healthcare managers. however, the national document did comprehensively covered issues of water, sanitation, hygiene, waste management and environmental cleaning. in addition, the global guidelines at the national level are not comprehensively implemented which will lead to recurrent insufficient data on wash in healthcare planning. the influence from the global level on universal health coverage implementation at the local level is positive, but efforts at the national level were directed at the number of citizens registering and medication supply. efforts should also be directed towards ensuring healthcare facilities have 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evaluation of wash fit in togo assessment of water, sanitation and hygiene in hcfs: which tool to follow? management information systems (hmis) review: survey on data availability in electronic systems for maternal and newborn health indicators in usaid priority countries wash in health care facilities; from resolution to revolution sanitation, and hygiene in healthcare facilities we are grateful to festus ogada, medical officer of health, kisumu east sub county, department of water and sanitation, ministry of health, kisumu county and cohesu, kenya for their contribution to this research during data collection. the authors declare no conflicts of interest. key: cord- -nr k hf authors: lemke, michael kenneth; apostolopoulos, yorghos; sönmez, sevil title: syndemic frameworks to understand the effects of covid- on commercial driver stress, health, and safety date: - - journal: j transp health doi: . /j.jth. . sha: doc_id: cord_uid: nr k hf introduction: u.s. commercial drivers are entrenched in a stressogenic profession, and exposures to endemic chronic stressors shape drivers’ behavioral and psychosocial responses and induce profound health and safety disparities. to gain a complete understanding of how the covid- pandemic will affect commercial driver stress, health, and safety over time, and to mitigate these impacts, research and prevention efforts must be grounded in theoretical perspectives that contextualize these impacts within the chronic stressors already endemic to profession, the historical and ongoing forces that have induced them, and the potentially reinforcing nature of the resulting afflictions. methods: extant literature reveals how an array of macro-level changes has shaped downstream trucking industry policies, resulting in stressogenic work organization and workplace characteristics. emerging evidence suggests that the covid- pandemic exacerbates existing stressors and introduces novel stressors, with potentially exacerbatory impacts on health and safety disparities. results: as covid- exerts an array of multi-level stressors on commercial drivers, syndemic frameworks can provide the appropriate theoretical lens to guide research and prevention. syndemic frameworks can provide the grounding to allow foregoing commercial driver covid- research to transcend the limitations of prevailing research frameworks by contextualizing covid- stressors holistically within the complex system of endemic chronic stressors and interrelated health and safety afflictions. syndemic-informed prevention efforts can then be implemented that simultaneously tackle multiple afflictions and the macro-level forces that result in the emergence of commercial drivers’ health and safety disparities over time. conclusions: the impacts of the covid- pandemic on commercial drivers cannot be adequately understood or acted upon in isolation from the endemic chronic stressors and interrelated health and safety disparities that characterize the profession. instead, commercial driver covid- research and prevention needs syndemic frameworks to holistically understand the impacts of covid- on commercial driver stress, health, and safety, and to identify high-leverage preventive actions. abstract introduction u.s. commercial drivers are entrenched in a stressogenic profession, and exposures to endemic chronic stressors shape drivers' behavioral and psychosocial responses and induce profound health and safety disparities. to gain a complete understanding of how the covid- pandemic will affect commercial driver stress, health, and safety over time, and to mitigate these impacts, research and prevention efforts must be grounded in theoretical perspectives that contextualize these impacts within the chronic stressors already endemic to profession, the historical and ongoing forces that have induced them, and the potentially reinforcing nature of the resulting afflictions. extant literature reveals how an array of macro-level changes has shaped downstream trucking industry policies, resulting in stressogenic work organization and workplace characteristics. emerging evidence suggests that the covid- pandemic exacerbates existing stressors and introduces novel stressors, with potentially exacerbatory impacts on health and safety disparities. as covid- exerts an array of multi-level stressors on commercial drivers, syndemic frameworks can provide the appropriate theoretical lens to guide research and prevention. syndemic frameworks can provide the grounding to allow foregoing commercial driver research to transcend the limitations of prevailing research frameworks by contextualizing covid- stressors holistically within the complex system of endemic chronic stressors and interrelated health and safety afflictions. syndemic-informed prevention efforts can then be implemented that simultaneously tackle multiple afflictions and the macro-level forces that result in the emergence of commercial drivers' health and safety disparities over time. the impacts of the covid- pandemic on commercial drivers cannot be adequately understood or acted upon in isolation from the endemic chronic stressors and interrelated health and safety disparities that characterize the profession. instead, commercial driver covid- research and prevention needs syndemic frameworks to holistically understand the impacts of covid- on commercial driver stress, health, and safety, and to identify high-leverage preventive actions. that the current pandemic simultaneously exacerbates existing stressors and introduces novel stressors, with potentially profound consequences that may exacerbate disparities. however, to gain a complete understanding of how the covid- pandemic will affect commercial driver stress, health, and safety over time -and to be able to ascertain how to best take action to mitigate these impacts -research and prevention efforts must be grounded in theoretical perspectives that contextualize these impacts within the chronic stressors already endemic to profession, the historical and ongoing forces that have induced them, and the potentially reinforcing nature of the resulting afflictions. thus, using u.s. long-haul truck drivers as an illustrative example, we advocate for using syndemic frameworks to guide research and prevention regarding the effects of the covid- pandemic on commercial driver stress, health, and safety. home for weeks at a time, which effectively makes their worksites their "homes" for prolonged periods of time. as a result, drivers are particularly dependent on the amenities available in these locales; however, these environments are notorious for lacking medical services or opportunities for physical activity and healthy eating. , , the mandatory prolonged periods away from family and friends, exacerbated by scheduling and financial pressures, lead to chronic social isolation , , that is compounded by a pervasive lack of respect for lhtd that is manifest through their numerous daily interactions with general public and, due to inherent job requirements to act as a boundary spanner, customers, dispatchers, and even the government. these multi-level chronic stressors often induce detrimental behavioral and psychosocial responses by lhtd and significantly contribute to their excessive health and safety disparities. there is a dearth of empirical investigation into the impacts of the covid- pandemic on commercial drivers, including lhtd, which is due to both the recency of this public health as the covid- pandemic exerts an array of multi-level stressors on commercial drivers, researchers need an adequate 'lens' through which to view these dynamically complex relationships and how they may induce multiple interrelated health and safety outcomes. instead, commercial driver covid- research and prevention needs syndemic frameworks to provide the appropriate theoretical lens to holistically understand the impacts of covid- on commercial driver stress, health, and safety 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applying contemporary systems thinking to road safety modelling and simulation of complex sociotechnical systems: envisioning and analysing work environments syndemics and the biosocial conception of health. the lancet syndemics: a new path for global health research. the lancet co-occurring epidemics, syndemics, and population health. the lancet • major policy changes have rendered commercial driving a stressogenic profession • commercial drivers' chronic stress exposures induce health and safety disparities • covid- likely increases drivers' chronic stress exposures and worsens disparities • commercial driver covid- research should be grounded in syndemic frameworks • syndemic-informed covid- prevention for drivers would be holistic and multi-level financial disclosure: the authors did not receive any specific funding for this work key: cord- -eme ztj authors: sarriot, eric; shaar, ali nashat title: community ownership in primary health care—managing the intangible date: - - journal: glob health sci pract doi: . /ghsp-d- - sha: doc_id: cord_uid: eme ztj although enduringly intangible, community ownership is foundational to primary health care. this intangibility is a reminder of what programs can and should do (create space for dialogue, question their own choices, expand diversity in stakeholder voices making sense of program-induced changes, including through evaluation) and what they cannot do (manage someone else’s ownership). the concept of community ownership in primary health care has a long history but remains challenged in terms of definition, measurement, and differences of perspective from practitioners on a gradient between utilitarianism and empowerment. it continues to be somewhat intangible. n although a universal definition across time and contexts may be illusory, contextual appreciation of its dynamic evolution under programmatic influences-for different stakeholders with diverse agendas-is accessible to evaluation and learning. n no one can "manage" someone else's ownership, but programs can reject hubris and tokenism by intentionally questioning their unavoidable impact on community ownership and whether they foster it through meaningful dialogue and "sense-making" with local stakeholders. see related article by fontanet et al. i n this issue of ghsp, fontanet et al. invite us to return to a concept that has existed since early discussions of community medicine and primary health care : community ownership in health. many of us who work in global health have felt and seen the excitement and sense of possibility when communities took charge, made a project "their own," innovated to find contextual solutions, and generated energy and hope in addition to buy-in for a lifesaving or health-promoting intervention. in , one of this article's authors witnessed how heavy rains had damaged a clinic serving the poor population of jiftlik in the jordan valley. without institutional funds to rehabilitate the structure, the village residents felt a sense of ownership and accountability and restored the clinic themselves, and this clinic is still providing services in . the literature is rich with case studies like this. [ ] [ ] [ ] as critical as community ownership is-and even foundational for many-it also appears to remain somewhat intangible, possibly impractical for some, and certainly complex for all. we consider some of the reasons for this quandary. the first stumbling block with community ownership is definitional. this naturally starts with, "what is community really?" this question is followed by-as we generally discuss social processes writ large rather than physical assets -"what is ownership?" we will satisfy ourselves for now with the idea that a community can be a geographically and demographically defined group of people, a network of people with a common agenda or challenge (illness), and/or most likely a combination of both of these, which creates the possibility of being in a community but outside of important social relationships. fontanet et al. remind us of the looseness of the concept of community ownership and frame it first under the paris declaration of aid effectiveness ; community ownership would fit with country ownership, albeit on a different, more local scale. (oxfam and save the children, for their part, see a shift in emphasis from community to country as "a more state-centric form of ownership." ) community ownership is sometimes defined through requirements for ownership, including capacity, empowerment, leadership, value found in the provision of a service, aspirations, and participation, or through consequences of ownership, including participation (again), financial commitment, contributions, and organization membership. [ ] [ ] [ ] [ ] [ ] [ ] these definitions can sometimes appear tautological-that ownership is defined by the fact of owning or institutionalizing a process or a goal. the literature associates ownership with sustainability of activities and outcomes, a means to achieve cultural adaptation for effective intervention models and to build problem-solving capacity. , , ownership can be described as a requirement to build community capacity in a health promotion effort, yet capacity can be presented a save the children, washington dc, usa. b palestinian child institute, an-najah national university, nablus, palestine. correspondence to eric sarriot (esarriot@savechildren.org). global health: science and practice | volume | number as a requirement of ownership. whichever way the causal link is created, it is presented on the path to effective and sustainable health interventions. countless evaluation reports have also associated failure of achievement and sustainability to the lack of community ownership generated by external projects. in the past, the concept has also been associated to financial contributions by communities, something critically revised through the universal health coverage agenda. much like the concept of participation, ownership lives in the tension between utilitarianism and empowerment, bridging over to human rights, democratic, and humanist perspectives on development processes. the ottawa charter for health promotion encouraged a process for enabling communities to increase control over and improve health and notably stated : health promotion works through concrete and effective community action in setting priorities, making decisions, planning strategies and implementing them to achieve better health. at the heart of this process is the empowerment of communities-their ownership and control of their own endeavors and destinies. advancing community ownership faces at least other challenges. although we support and believe in the ottawa charter's vision of seeking to increase people's control over their own health, we must also acknowledge that calls for ownership and "full participation" (as in the recent astana statement ) sometimes contain an element of idealism that pragmatists can occasionally point out with a wink or with cynicism in the face of harsh "field" realities. community members may in fact be satisfied sometimes by simply being clients of health services. demands for social accountability surge when quality, equity, responsiveness, and access conditions are not met. but when they are, people might satisfy themselves with utilizing, rather than owning, a service. indeed, public health problems are defined in a context, and these "problems-in-context" demand specific solution configurations, not all of which require the same level of social engagement. people responding to an acute threat might not perceive ownership as an immediate priority. of course, the global health community had to rapidly re-discover the importance of building a response with communities in the ebola emergency and efforts to eradicate polio. , the current global challenges with vaccine acceptance and the coronavirus disease (covid- ) situation are also signaling that some form of ownership is required for scale, sustainability, and impact of interventions. still, we must also acknowledge that many shortterm bets can be won with money and energy invested in proximal determinants of health. ownership is critical but may be a distal determinant of success. we undermine our own advocacy if we appear to take for granted the value of technicity, policy, and organization in solving health challenges and present ownership in absolute terms. why are we asking about ownership ultimately? because although they are always well-intended, not infrequently effective, and sometimes sustainable, our external projects inherently displace power and ownership from "natural" social systems (if there is such a thing). we punctuate an equilibrium, if not of ownership, at least of acceptance or resignation to a social baseline, but unless some new equilibrium of ownership is found between diverse stakeholders, the system will be attracted back to its baseline or some other suboptimal state. ignoring this tension poses a great risk of hubris. we know the stereotype: experts can come and "give messages," tell people what the evidence says, and incentivize them to follow their plan, while failing to listen honestly and with respect to the local and community-appropriate ideas for adaptation of the approaches. white elephants are built. without being a cynic, simply having self-satisfaction with giving token respect for the value of community ownership or coopting can lead to asking the wrong questions, in other words, having a poor definition of what problems really need to be addressed in context. policy makers close a market to create social distancing; populations protest because they weigh differently an epidemiological risk against the necessity of feeding their family; the market reopens, but no effective community-owned risk reduction solution has been developed. although the concern about projects' displacement of ownership may have been born out of an evolution of international programs away from colonialism, "do-gooding," and hubris, it also applies to any national or regional program trying to reach remote, poor, minority, or neglected areas. displacement of ownership is not an we undermine our own advocacy if we appear to take for granted the value of technicity, policy, and organization in solving health challenges and present ownership in absolute terms. international development problem; it is a universal central-to-local (resource rich to resource poor) development problem. and while "we" question "their" ownership, we are rarely fully accountable for what role and agency we choose to keep to ourselves as we transition. we already mentioned different dimensions through which ownership has been framed. efforts at measurement naturally must also be multidimensional, but this is not the greatest measurement challenge. research may be able to draw conclusions from a distance on the ownership demonstrated by various communities and stakeholders, but program evaluation-seeking to assess what allows or hinders ownership during implementation-must be carried out with the stakeholders or else be meaningless. as is the case for assessing institutional capacity, assessing or measuring ownership requires that the "owners" at least acquiesce to the process. a thought experiment can make the point. how would our employers or neighbors react to an outsider knocking on their virtual door to measure their ownership of a stated goal? while accepting to step on the scale does not influence the weight that will be posted on the scale, the measurement of a community's ownership has community prerequisites in terms of buy-in and boundary decisions (who is the community and who is asking the question?). the prerequisites for measuring ownership are not independent of the ownership variable. it is noteworthy that fontanet et al. allowed different stakeholders to define their ownership differently. elements of subjectivity seem unavoidable-not something typically desired in project performance management. this subjectivity comes with management challenges. projects try to manage by results and give evidence for achievements. we develop indicators that are as objective and reliable as possible. but when it comes to measuring changes in a social system, our log frames and theories of change are challenged to capture the interaction between our programs and social dynamics over time. we say that we "cannot manage it if we cannot measure it," but given the nature of the question, can we ever manage the ownership of someone else? then, what are we trying to measure, who should be doing the measurement, and over what timeframe, if ownership evolves on a different timeline than service outputs? last and not least, ownership in a complex social system is always changing (dynamic) and can be affected by small changes in interpersonal relationships, services, or operational rules. a new equilibrium between stakeholders comes with new rules and boundaries, and questions may be raised about the ownership allowed for newcomers. the stakeholders of community ownership will change, their relationships will change, their perspectives will evolve, as shown by fontanet et al. over just a -month period. this leaves us with a series of limitations: we should assess our impact on community ownership, but our measurement is likely to be subjective and flawed. we want to be accountable for progress, but community ownership is precisely about things that we must let go of. we should be concerned about community ownership, but we still cannot totally define it. its local definition depends on who sits around the table. it may change and change substantially based on small evolutions of the problem-in-context. should we just abandon all hope? perhaps not. social scientists will continue to enrich our understanding by dissecting ownership for different problems and contexts. the measurement challenge may be like that of social capital, for which operational measures can be defined in different contexts, even if a set of universal measures for all contexts may remain out of reach. fontanet et al. interestingly circumvent some of the challenges by exploring with qualitative rigor the perceptions of ownership, providing substance to the concept from stakeholders, who have different but compatible definitions of what ownership is to them. the intangible is not made totally tangible, but the local meaning for stakeholders provides guidance to continue developing a program. another role of research may thus be to provide substance for advocacy and to challenge approaches that deny agency to marginalized communities. not all programs have access to strong research capability. however, they can use monitoring, learning, evaluation, and accountability tools to limit disrupting ownership or even to foster it. promoting community ownership and learning about its development may be more akin to generating new social equilibria than planning for the delivery of a discrete outcome. it demands genuine interactions, creating enabling conditions and spaces for incremental changes, and building shared values. these ideas are not far from the concept of "harnessing complexity" in complex social and institutional systems. it quite possibly will require monitoring "us"-how we use our money, power, and time, and maybe addressing more critically when we must act and when we must choose to use restraint-as much as measuring "their" ownership. sustainability-conscious public health practitioners, whether national or international, may not need to worry about precisely measuring the state of community ownership, but to focus more on which agents of the local system are taking agency, how much, and how diverse voices give meaning to tangible changes and intangible perceptions about structures, services, actions, relationships, and values. if we are intent on finding viable long-term solutions to primary health care challenges with a view of sustainable development, transition, and the "journey to self-reliance," the greatest mistake may be failing to critically engage in questioning our projects' effects on community ownership and to mistrust the ability of communities to be agents of change. as messy as it may be. a qualitative exploration of community ownership of a maternity waiting home model in rural zambia community medicine: teaching, research and health care. appleton-century-crofts educational division world health organization institutionalizing communityfocused maternal, newborn, and child health strategies to strengthen health systems: a new framework for the sustainable development goal era comprehensive review of the evidence regarding the effectiveness of community-based primary health care in improving maternal, neonatal and child health: . summary and recommendations of the expert panel just and lasting change: when communities own their futures how does community-led total sanitation (clts) affect latrine ownership? a quantitative case study from mozambique declaration on aid effectiveness and the accra agenda for action the power of ownership: transforming us foreign assistance. save the children, oxfam community capacity as means to improved health practices and an end in itself: evidence from a multi-stage study. int q community health educ community participation in health systems research: a systematic review assessing the state of research, the nature of interventions involved and the features of engagement with communities how do community health committees contribute to capacity building for maternal and child health? a realist evaluation protocol design of a community ownership and preparedness index: using data to inform the capacity development of community-based groups community participation: lessons for maternal, newborn, and child health beliefs, behaviors, and perceptions of community-led total sanitation and their relation to improved sanitation in rural zambia unlocking community capabilities across health systems in low-and middleincome countries: lessons learned from research and reflective practice implementation of the bamako initiative: strategies in benin and guinea community participation in health: perpetual allure, persistent challenge ottawa charter for health promotion. who the political economy of the ebola virus disease (evd); taking individual and community ownership in the prevention and control of evd community engagement, ownership, and civil society organizations in polio eradication vaccine hesitancy: the next challenge in the fight against covid- monitoring and evaluating the transition of large-scale programs in global health hubris, humility and humanity: expanding evidence approaches for improving and sustaining community health programmes social capital and health in the least developed countries: a critical review of the literature and implications for a future research agenda united nations development program (undp) united states agency for international development. the journey to self-reliance. helping countries to solve their own development challenges acknowledgments: thank you to erica nelson, lenette golding, and judy sarriot for technical and editorial inputs. competing interests: none declared. key: cord- -uffxyas authors: gagliano, annalisa; villani, pier giorgio; co’, francesca m; manelli, anna; paglia, stefano; bisagni, pietro a. g.; perotti, gabriele m; storti, enrico; lombardo, massimo title: covid- epidemic in the middle province of northern italy: impact, logistics, and strategy in the first line hospital date: - - journal: disaster medicine and public health preparedness doi: . /dmp. . sha: doc_id: cord_uid: uffxyas the novel coronavirus (covid- ) began in china in early december and rapidly has spread to many countries around the globe, with the number of confirmed cases increasing every day. an epidemic has been recorded since february in a middle province in northern italy (lodi province, in the low po valley). the first line hospital had to redesign its logistical and departmental structure to respond to the influx of covid- -positive patients who needed hospitalization. logistical and structural strategies were guided by the crisis unit, managing in days from the beginning of the epidemic to prepare the hospital to be ready to welcome more than covid- -positive patients with different ventilatory requirements, keeping clean emergency access lines, and restoring surgical interventions and deferred urgent, routine activity. in early december , the first pneumonia cases of unknown origin were identified in wuhan, the capital city of hubei province. the pathogen has been identified as a novel enveloped rna betacoronavirus- that currently has been named severe acute respiratory syndrome coronavirus- (sars-cov- ), which has a phylogenetic similarity to sars-cov. patients with the infection have been in the hospital, in family and work environments, and in communities. the world health organization has recently declared the novel coronavirus disease (covid- ) a public health emergency of international concern. , at the end of january , mainland china reported confirmed cases of covid- infections that resulted in deaths. , initially, cases were thought to arise from zoonotic transmission; however, recently published literature reveals evidence of human-to-human transmission that increased exponentially by travel, with many cases detected in other parts of the world. [ ] [ ] [ ] this geographic expansion beyond the initial epicenter of wuhan provides an opportunity to study the natural history of covid- infection. in relation to the transmission risk of covid- , on january , , the italian ministry of health issued the first order with prophylactic measures against covid- . after the first one, many ordinances and regulatory circulars defined both prevention measures of behavioral and treatment rules for suspected cases. on february , , the first case of sars-cov- was confirmed in a hospital in codogno, italy (a little city of lodi province in the low po valley), hereafter defined as the "red zone" (no entry or leave zone, including cities around codogno, with quarantine commitment for all citizens). this represented the starting point for extraordinary measures of national and regional management evolving on the basis of the infections registered. from the first diagnosis, the emergency department (ed) of codogno hospital was closed to new patients and all routine and elective activity interrupted, "freezing" the hospital at time zero of diagnosis while maintaining the care for patients already hospitalized within the hospital and ensuring their normal care and management. the influx of patients was then diverted to major hospital in lodi, which became the first line hospital. it is necessary to change the hospital organization to manage the eventual epidemic and identify the institutional interfaces. the tracks to follow include the first management of the territorial social health company (asst; azienda socio sanitaria territoriale) and the second institutional: region and government. the management of the hospital was entrusted to the crisis unit. lombardy region government transferred to lodi major hospital's crisis unit complete decision-making power, without the hospital ethics board and master and commander approval. the crisis unit was formed involving hospital staff (general health, nursing), department directors, logistics heads, representatives of critical units in the management of covid- patients, and press coordinator. there was direct collaboration of the prefecture government, law enforcement, civil protection, city, province, and regional governments, as well as indirect collaboration with the national health institution, government, and ministry of health. the critical points presented at time zero (ie, first diagnosis) arose at various levels: • sanitary: how many patients in which distribution, with what type of presentation • staff: who came into contact with others in quarantine who tested positive for sars-cov- , to whom and when to buffer, how many available for the various areas • logistics: which and how many drugs, which and how many consumer supplies, how many and which ventilation systems, how much oxygen, possibility of rapid re-supplies • structural: possibility of structural changes within the hospital and any destination use, change, materials, workforce the main problem immediately encountered was the fluidity and rapidity of requests and the need to change the hospital configuration on the basis of needs. it is almost impossible to redesign physical spaces and restructure management from the beginning. the defined structure was therefore a fixed structure of the management unit (crisis unit) consisting of meetings per day at am and pm to verify progress and needs and to respond and check the effectiveness of the maneuvers put in place. major hospital has beds organized in departments, of which belong to the health department, to the administrative department, and to the social health department. the intensive therapy department has beds and in non-urgent, routine activity, the ed has near access a year with a population of the low po valley nearly to people. what and how must this be changed? at the same time, the ed collected data on access and real needs of patients, operating from time zero a carefully and timely collection of epidemiological and health data and initiated a process of change in the management of a triage system. this model set made it possible to completely reorganize the hospital's infrastructure in days. we analyzed the changes made in each area and illustrated logistics and needs. the director of the ed instituted from the first case a careful data collection of the number and trend of patient access. in the first day, we received patients with a rate of high flux access every hours for a total number of . patients accessed and the trend of treatment were focused on the resolution of acute respiratory failure, but without real knowledge of the presentation of symptoms. the observation in the first days allowed us to identify the common symptoms and signs of the infection, and from this observation the director of the ed designed a model to effectively triage patients and obtain rapid frame rates of respiratory failure and responsiveness of the patients to the oxygen treatment. the director was able to redistribute the ed areas for the different types and needs of patients in scale model and at the same time develop clinical documentation of rapid interpretation to evaluate the improvement or deterioration of the patients (figure ), all the while identifying the necessary devices to guarantee the treatment of symptoms. the evaluation of simplified parameterstemperature, oxygen saturationwas registered in a nominal parameter sheet and attached to the patient's stretcher and artery blood gas analysis. the schematization and optimization made it possible to identify necessary devices and supplies: oxygen mask, continuous positive airway pressure (cpap) and ventilation system, stretchers, syringes, personal protective equipment (ppe), , and antibiotics. the ed represented the key node for the remodeling of the hospital based on the accesses and the first epidemiological data collected. at the end of the first high influx of patients, we needed intensive care unit (icu) beds, beds for patients using ventilation support (cpap), and beds for patients with pneumonia using oxygen support. it's not possible to wait for the result of the test from a nasopharyngeal swab (collecting a sample from the back of the nose and throat), because the influx of patients into the ed was at a -hour rate and test results came in nearly hours. the ed has been available for non-covid- patients with direct access after triage and dedicated diagnostics, where visiting rooms and a shock room for red codes have been set up. the health care distribution of the hospital has been completely changed since the third day of the emergency and with fluid progress on the basis of needs. the first measures covered critical areas. but as a first step it was necessary to stop all routine and non-urgent outpatient activity to provide more efficient discharge processing of patients and to free up as many beds as possible in the wards. after the recruitment of beds, it was necessary to change the wards destination and the structural creation of filter zones. , • intensive care: from time zero, all patients hospitalized in "subintensive" (pulmonary failure or cardiac failure) observation beds were sent to the ordinary ward and such beds were recovered as icu beds. this allowed increasing the icu capacity from beds to and predisposing in operating rooms intended for routine minor surgery with available ventilators, lifesaving places for non-viral patients. potentially ventilator-equipped) of beds became a critical pneumological area. it was possible to do this in days with structural and logistical changes, creating a filter zone, and defining warehouse and sanitary areas. after these, more -bed wards were set up for patients with oxygen needs without the need for intensive or sub-continuous monitoring and again intervening on structure and logistics. at the end of the first week, the hospital completely changed its face. this has also allowed the resumption of deferred urgent activities, including surgical activity. • radiology: ed radiology (ct scan, ultrasound, and portable xray machine) and conventional x-ray rooms were considered dirty; the x-ray rooms, the ct scan, and the mri scan site on the ground floor have been defined as clean and usable for non-covid- patients. • service: cleaning service has redefined tools to use and the cycle of service, the kitchen prepared packages with disposable portions for dirty areas. • direction: permanent crisis unit with scheduled meetings ( per day at am and pm) -press office planning and links with prefecture, region, and external law enforcement agencies; connection with wuhan and with international newspapers; supplies on the basis of the need to renegotiate existing contracts to increase the amount of use of the supplies themselves. • pharmacy: sorting and controlling use of drugs and ppe; connection with ethics committee for antiretroviral therapy in patients with sars-cov- . the change was completed, affecting the entire hospital on the eighth day. there was a need for a redistribution of medical and nursing staff for structural changes and to redistribute the staff on duty (not quarantined). driving permits from the red zone were given to the medical staff of every degree in order to ensure the assistance and the attainment of the workplace. at the same time, the recruitment of external staff was necessary. there has been voluntary recruitment in the other regional facilities and in the health sector of the army. triage model in emergency department, asst lodi. holiday and temporary leave was suspended, and the hospital has been staffed to provide day and night care in all wards. surgery at all times has guaranteed emergencies with operating rooms activated by day, at night, and guaranteed deferred urgency on a shared operating room between general and specialty surgeries. the literature data available at the time of the emergency were few and, above all, stemming from the only experience available on the outbreak from covid- . the only country with published data and epidemiological or management studies was represented by the chinese reality. , , , however, the health system and the chinese government represent a very far model from the italian reality where health is regional and where each asst has significant autonomy, such as the possibilities available to try to improve and optimize management and logistical choices. applicable and effective models could result: major-emergency management and military management. both systems ensure resource optimization in relation to large inflows. starting from the concept of advanced medical post and the use of the action plan for the major-emergency, we were able to organize the crisis unit as the hospital's operations center. at the same time, however, we were not certain about the number of infections or about the real needs of patients. this was the critical point for the initial management. it was therefore necessary to initiate internal analyses that were possible due to the efforts of the ed where epidemiological and health data are recorded up to the first access. after hours, it was therefore possible to have not only the pattern of inflows, but also a realistic prediction of the necessary resources. every effort was made to have a fluid model inside the hospital. prospectively, patient management presents a linear management mode for patients who respond to only oxygen therapy: from ed to ward, circular one for the patient in need of ventilator support, from the ed will have to be allocated in of the ventilated areas (depending on the need: icu or sub-intensive) and then return to the ward. the hospital day by day owing to the data collected and to the great structural and logistical effort was designed as a fluid and circular model. however, the confrontation with the regional government and its health facilities has become decisive and fundamental. in fact, the circular model provides for the need for the involvement of different structures. the firstline hospital, in this case, is represented by a provincial hospital with a capacity limited to beds. the role of the first-line hospital is to ensure framing and need of the patient, but largescale management of the patients involved must be matched. this is why the regional network and transfers made it possible not to collapse at the first accesses of the frontline structure. this dynamics model was difficult to realize without reference models and without knowing the number of casualties, and this was not possible to obtain from the beginning; but the presence of all the representations in the management of the crisis has meant that, despite the low sensitivity of prospective data, the model has been applied allowing the management of the first phase of the emergency. in the same way, decentralized management of the first phase in the frontline hospital has allowed other structures, albeit in different ways, to prepare suitable space and line of management for covid- patients. while in the red zone, the numbers began to grow new oil-spot infections that started to show up in the region, showing the same trend as the chinese epidemic. at this point, having a management model at our disposal could be the key to better addressing and optimizing the use of resources. the need for a quick response drove the hospital's choices for change. centralizing and managing through the crisis unit has enabled and made change possible. at the end of the first week, the restructuring and the triage and treatment guaranteed by the ed brought the ability of the hospital to manage up to patients in the ed without collapsing and at the same time ensured the management of the patients and the capacity of the hospital according to need. everything was possible due to the efforts of the medical and nursing staff, who have been redeployed to reinforce critical areas and replace quarantined operators, ensuring maximum assistance. coordination of the crisis unit with regional military and government authorities has enabled the centralization of the problem. from the moment that the biohazard emergency represents a certain epidemic, it's necessary that coordination be increased to a higher level than asst one and that the "modular" structure can be coordinated at the regional level to ensure increased effectiveness and availability of beds for the health of citizens. the management on the front line also highlights the need to have a major emergency management plan that is diversified due to the biohazard epidemic, and, in this case, the plan should be regional and agreed in increasing stages of action with a commitment of resources with a structured and centralized model. in this way, both the structures and work units (nurses, doctors, and administrative or health support staff) will be managed as the total account and with progressive commitment. this could also ensure that any infections among the staff are replaced. even for logistics, the ability to increase coordination on the basis of total resources would ensure adequate supply as needed, and also cost would be able to preserve the right value. the conclusion of this first phase then creates talking points to improve and optimize the responsiveness of the national health systems. epidemiological characteristics of novel coronavirus: an interim review world health organization coronavirus disease (covid- ) outbreak a novel coronavirus outbreak of global health concern national health commission of the people's republic of china: update of pneumonia of new coronavirus infection as of : on real time estimation of the risk of death from novel coronavirus ( -ncov) infection: inference using exported cases world health organization. coronavirus disease (covid- ) situation reports nowcasting and forecasting the potential domestic and international spread of the -ncov outbreak originating in wuhan, china: a modelling study the next big threat to global health? novel coronavirus ( -ncov): what advice can we give to travellers? -interim recommen-dations incubation period and other epidemiological characteristic of novel coronavirus infections with right truncation: a statistical analysis of publicly available case data the novel coronavirus: a bird's eye view comparison of perceived and observed hand hygiene compliance in healthcare workers in mers-cov endemic regions handwashing practice and the use of personal protective equipment among medical students after the sars epidemic in hong kong world health organization. coronavirus disease (covid- ) technical guidance: laboratory testing for -ncov in humans management of biohazard in health care system the comprehensive medical preparedness in chemical emergencies: "the chain of the chemical survival evaluating the viricidal efficacy of hydrogen peroxide vapour characteristic of hospitalized patients with novel coronavirus -infected pneumonia in wuhan hospital outbreak of middle east respiratory syndrome coronavirus preclinical and intrahospital management of mass casualties and terrorist incidents logistic preparedness of chosen urban agglomeration hospitals to act during massive chemical disaster covid- in the middle province of northern italy disaster medicine and public health preparedness disaster medicine and public health preparedness the authors have no conflicts of interest to declare. key: cord- - tqi n authors: hunter, anita; wilson, lynda; stanhope, marcia; hatcher, barbara; hattar, marianne; hilfinger messias, deanne k.; powell, dorothy title: global health diplomacy: an integrative review of the literature and implications for nursing date: - - journal: nurs outlook doi: . /j.outlook. . . sha: doc_id: cord_uid: tqi n the increasing interconnectedness of the world and the factors that affect health lay the foundation for the evolving practice of global health diplomacy. there has been limited discussion in the nursing literature about the concept of global health diplomacy or the role of nurses in such initiatives. a discussion of this concept is presented here by the members of a task force on global health diplomacy of the american academy of nursing expert panel on global nursing and health (aan epgnh). the purpose of this article is to present an integrative review of literature on the concept of global health diplomacy and to identify implications of this emerging field for nursing education, practice, and research. the steps proposed by whittemore and knafl ( ) were adapted and applied to the integrative review of theoretical and descriptive articles about the concept of global health diplomacy. this review included an analysis of the historical background, definition, and challenges of global health diplomacy and suggestions about the preparation of global health diplomats. the article concludes with a discussion of implications for nursing practice, education, and research. the task force endorses the definition of global health diplomacy proposed by adams, novotny, and leslie ( ) but recommends that further dialogue and research is necessary to identify opportunities and educational requirements for nurses to contribute to the emerging field of global health diplomacy. the increasing interconnectedness in the world that has resulted from globalization has significant implications for nursing and healthcare. the american academy of nursing expert panel on global nursing and health (aan epgnh), whose members are active participants in the global arena, recognize that health problems transcend national borders and that all nurses must be prepared to address global health challenges. since , global health has become the top foreign policy issue of our times (labonté & gagnon, ) , encouraging the interaction of state and nonstate participants to position health issues more prominently in foreign policy decision-making. this process and the engagement of all key stakeholders are parts of a new approach to global health called "global health diplomacy" (labonté & gagnon, ) . nurses who work in the global health arena need to be aware of this new emphasis and identify their responsibilities as global health diplomats. novotny and adams (novotny & adams, ) defined global health diplomacy as "a political change activity that meets the dual goals of improving global health while maintaining and strengthening international relations abroad, particularly in conflict areas and resource-poor environments [and that] health diplomacy is not only the job of diplomats or health leaders in government structures, it is a professional practice that should inform any group or individual with responsibility to conduct research, service, programs, or direct international health assistance between donor and recipient institutions" (p. - ). to better inform nurses about the concept of global health diplomacy, this paper presents an integrative review of literature on the concept of global health diplomacy and identifies implications of this emerging field for nursing education, practice, and research. whittemore and knafl ( ) described an integrative review of the literature as the broadest type of research review, combining data from both empirical and theoretical literature to define concepts, review evidence, review theories, and analyze methodological issues. those authors modified the original framework for literature reviews proposed by cooper ( ) and suggested that an integrative review should include: (a) a clear statement identifying the problem or purpose of the review; (b) identification of the strategies used to search and identify relevant literature; (c) evaluation of the quality of the data; (d) analysis of the data; and (e) final synthesis and presentation of the data. whittemore and knafl ( ) acknowledged that many strategies can be used for each of these stages. the purpose of this review was to analyze the concept of global health diplomacy and identify implications of global health diplomacy for nursing practice, education, and research. the framework proposed by whittemore and knafl ( ) was used to organize the review. we did not find reports of empirical research other than descriptions of existing health-diplomacy programs, so our review focused on theoretical articles and empirical descriptions of global health initiatives. the articles included in this review were identified by searching the cumulative index to nursing and allied health literature (cinahl) and pubmed databases using the search term "global health diplomacy," without specifying any date restrictions. additional articles were identified by reviewing reference lists of the original papers, and by searching google scholar using the keywords "global health diplomacy." empirical or theoretical articles were included in the review if they addressed the historical development of global health diplomacy, defined the components and challenges of health diplomacy, proposed future development of global health diplomacy, and/or discussed strategies for preparing global health diplomats. to evaluate the quality of the articles that were included in the review, the authors adopted one of the strategies proposed by whittemore and knafl ( ) , which was to consider authenticity, informational value, representativeness of sources, and methodological quality of each document that was included in the review. to analyze and synthesize the data from these diverse sources, the authors reviewed all papers, wrote annotated summaries of each paper, and then developed a system for classifying the articles, displaying the data, comparing the themes that emerged from each paper, and drawing inferences and conclusions, using the methods proposed by whittemore and knafl ( ) . the review is organized according to the main themes that emerged from analysis of the papers: historical development of global health diplomacy, definition and components of global health diplomacy, challenges in global health diplomacy, and preparation of global health diplomats. the review concludes with the authors' recommendations and implications for nursing practice, education, and research. the term global health refers to "an area for study, research, and practice that places a priority on improving health and achieving equity in health for all people worldwide. global health emphasizes transnational health issues, determinants, and solutions; involves many disciplines within and beyond the health sciences and promotes interdisciplinary collaboration; and [it] is a synthesis of population based prevention with individual-level clinical care" (koplan et al., (koplan et al., , p. . adams, novotny, and leslie ( ) defined global health diplomacy as "an emerging field that addresses the dual goals of improving global health and bettering international n u r s o u t l o o k ( ) e relations, particularly in conflict areas and in resourcepoor environments" (p. ). katz et al. ( ) proposed that the varying definitions of global health diplomacy fall into three different categories ( ) core diplomacy or formal negotiations between and among nations; ( ) multi-stakeholder diplomacy or negotiations that are not necessarily intended to lead to binding agreements; and ( ) informal diplomacy or interactions between international public health actors and their counterparts in the field, including host country officials, nongovernmental organizations (ngos), private-sector companies, and the public. identifying these different categories of global health diplomacy may be important to clarify services/resources that may be offered, especially when governments argue for incorporating health issues into their foreign-policy debates (kaufmann & feldbaum, ) . global health diplomacy combines the art of diplomacy with the science of public health; it balances concrete national interest with the abstract collective concern of the larger international community's health; it reduces health inequities; it secures human rights; and it recognizes that effective international health interventions are ethical and sensitive to historical, political, social, economic, and cultural differences (schrecker, labonté , & de vogli, ; world health organization, ) . the plethora of definitions supports the basic premise that global health diplomacy encompasses a political change activity and requires both the art of diplomacy and the science of public health to promote formal negotiations between and among nations and international public health actors and their counterparts in the field to address security, development, global public goods, trade, human rights and ethical/ moral reasoning. there is growing recognition of the importance of promoting global health. the united states (u.s.) institute of medicine (iom) ( a, b) published two reports outlining recommendations to enhance the u.s. commitment to global health. a consortium of universities for global health (cugh) was developed in with a mission to define the field of global health, standardize curricula, expand research, and coordinate projects in low-resource countries (consortium of universisties for global health, ). the center for strategic and international studies (csis) ( ) was also commissioned to identify recommendations for smart global health policy in the united states, and for the first time, the u.s. national institutes of health ( ) made global health one of its top five priorities. the u.s. government document healthy people (united states department of health and human services, ) included a new global health goal for the first time in the history of the healthy people series: to improve public health and strengthen u.s. national security through global disease detection, response, prevention, and control strategies. the healthy people document outlines the u.s. objectives for meeting this new global health goal to address continuing emerging disease threats: promote health abroad, prevent the international spread of disease, and protect the health of the u.s. population. badeau ( ) described the historical evolution of the concept of "medical diplomacy," noting that centuries ago physician-priests sometimes accompanied egyptian missions to neighboring countries and acted as ambassadors. he also noted that the nature of diplomacy changed following world war i and that diplomacy is no longer the purview of only a small elite corps of professional diplomats. factors such as improved communication, educational levels, an end to colonial rule in many parts of the world, and increased public demand for civic participation has resulted in changes in the face of diplomacy. fidler ( ) suggested that health diplomacy emerged because of global threats to public health in the th century. the marshall plan, the end of the cold war era, and the medical assistance provided by the u.s. military in europe and japan following world war ii signaled increased emphasis on the importance of foreign aid and "persuasion" as a key component of foreign diplomatic initiatives in both the u.s. and in other countries (adams, et al., ; badeau, ) . feldbaum, lee, and michaud ( ) noted that global health has historically been of importance in foreign policy as evidenced by the international sanitary conventions that began in . these international sanitary conventions subsequently evolved into the international health regulations (ihr), focused on enforcing disease control with minimum interference with international trade (world health organization, ) . feldbaum et al. ( ) suggested that although the world health organization (who) has had problems enforcing ihrs in the past, the e outbreak of the severe acute respiratory syndrome (sars) resulted in revision of ihrs and granted the who authority to supersede interests of member states using surveillance data for purposes of infectious disease control. those authors further described the historical link between international aid and foreign policy interests, which was a key factor in the establishment of the u.s. agency for international development (usaid). addressing health without addressing the causative factors for illnesses has contributed to the failure of many well-intentioned global health programs. cahill ( ) called for "the diplomatic potential of medicine as a vehicle for international goodwill" (p. ). subsequently, cahill ( ) introduced the term "preventive diplomacy," noting that diplomats and politicians frequently lack an understanding of the health and humanitarian issues that they address and challenged health professionals to become active in addressing global health and human rights issues to offer innovative approaches to health and human rights issues that may be more effective than the methods used in the past. katz, kornblet, arnold, lief, and fischer ( ) noted that the concept of medical diplomacy was first introduced in the carter administration in , as a "vehicle by which channels of communication can be established between nations when international relations are strained or severed" (p. ). feldbaum et al. ( ) noted three recent trends in international aid to address health issues: (a) dramatic increase in funding for health; (b) increased number of organizations involved; and (c) a tendency to focus on hiv/aids as a single health problem. others have also noted the increase in health-related aid and the increased international focus on hiv/aids (ravishankar et al., ; shiffman, berlan, & hafner, ) . other factors that have contributed to the growing interest in global health diplomacy include the growth of ngos participating in international health programs, the increasing globalization of science and of pharmaceutical research, and growing concerns about biosecurity (adams, et al., , p. ) . a major impetus to the development of global health diplomacy is the concern about threats to global health security. the who annual report focused on threats to global public health security, such as epidemic diseases, food-borne diseases, accidental or deliberate outbreaks (e.g., nuclear accidents, toxic spills), environmental disasters, and the identification of strategies to minimize and address those threats (world health organization, a). chan, director general of the who, argued for "..inputs from policy analysis and research; . [and] improved training opportunities for both diplomats and public health specialists in the interface between health and foreign policy" (chan, store, & kouchner, , p. ). kickbusch and buss ( ) described the use of health diplomacy to promote peace and to encourage the evolving global partnerships of countries across hemispheres to address global health issues. the authors cited several examples of global health leadership roles and emphasized the importance of the who in providing global coordination for the multiple initiatives in the often-overcrowded global health landscape. for example, in brazil hosted the "global conference on social determinants of health," and in may , the world health assembly formally accepted the "health as a bridge for peace" initiative as a feature of the "health for all in the st century" strategy (world health organization). who launched the "health as a bridge for peace initiative," promoting cease-fires during times of conflict to permit health projects, such as vaccination campaigns, and promoting collaboration in training initiatives among countries that were previous enemies (rodriguez-garcia, schlesser, & bernstein, ). further, the foreign ministers of brazil, france, indonesia, norway, senegal, south africa, and thailand issued the oslo declaration and agenda for action to increase the priority of global health issues in foreign policy (amorim et al., ) . barber, cohen, and rockswold ( ) noted that in the united states, the field of global health diplomacy has been bolstered by the $ billion u.s. global health initiative that was launched in to address hiv/aids, growing challenges posed by chronic diseases, and to strengthen health systems. labonte and gagnon ( ) reviewed the literature published from to to identify arguments that governments have used to incorporate health issues into their foreign policy deliberations. the literature revealed six policy frames: security, development, global public goods, trade, human rights and ethical/ moral reasoning, noting that arguments within the different frames are sometimes contradictory. the most frequently mentioned argument was concern for national and economic security, followed by the use of health to stimulate development and promotion of the public good (by preventing pandemics, addressing problems related to climate change, or regulating health-damaging products such as tobacco). in summary, the notion of incorporating medical or health care in foreign policy or international aid programs is not new; however, there has been limited discussion about this concept in the nursing literature. badeau ( ) described a key challenge related to health diplomacy initiatives, noting that "the use of aid for political ends is always resented by those who receive it, but it is particularly resented when that aid deals with basic human needs such as food or health" (pp. - ). other authors have also identified this challenge, particularly when aid that is tied to political ends addresses basic human needs such as food or health. in addition, focusing on health as a political instrument often limits the ability of global health initiatives to address priority health problems in a sustainable way (feldbaum, et al., ; institute of medicine, a; kickbusch & buss, ; kickbusch, silberschmidt, & buss, ) . ingram ( ) identified three potential problems with the use of health as a foreign policy tool: (a) decreasing the credibility of health workers who have previously been viewed as neutral and not involved with state politics; (b) giving priority to narrow state interests over the interests of alliances needed to address global health issues; and (c) focusing on health as a political instrument rather than a human rights issue. to address the potential challenges associated with linking healthcare assistance to foreign policy goals, badeau ( ) advocated separating u.s. foreign aid that addresses basic human needs for food, health, and education from other technical assistance programs and placing the responsibility for such programs with a private organization that receives u.s. governmental funding (similar to the model of the british council in the united kingdom). labonté and gagnon ( ) noted that some have recommended explicit ethical principles to guide policy decisions to prevent the "high politics" of foreign policy from consistently overriding the "low politics" of global health (p. ). lemery ( ) suggested that the u.s. state department engage physicians in "white coat diplomacy" to address humanitarian needs and foster "good will," but noted the concern of academic skeptics who fear that linking healthcare services to diplomatic goals might invite "manipulation." novotny ( ) noted the instances of interference by federal agencies into the scientific independence of global health programs, such as restrictions on travel, scientific input, and collaboration. other challenges for global health diplomacy relate to confusion and failure to develop a common definition of the concept of global health security, the conflict between the rights of individual nations versus the need for international health regulations (aldis, ) , and the increasing number of stakeholders interested in global health issues and the potential problems resulting from failure to coordinate global health initiatives (katz, et al., ) . an example of this conflict was indonesia's refusal in to share influenza virus samples with the who collaborating centers on influenza that traditionally receive samples from around the world for analyses to be used in development of new vaccines. indonesia's refusal was based on the perception that the vaccines would be used to benefit only wealthier nations and would not benefit indonesia (katz, et al., ) . many writers have emphasized the importance of coordination of global health initiatives by groups such as the world health assembly (chan, et al., ; kickbusch & buss, ; novotny, ) . it is important for nurses to be aware of the potential ethical issues that arise when healthcare that is provided as a foreign-policy tool decreases the credibility of health workers who have previously been viewed as neutral and have not been involved with state politics; when it gives priority to narrow state interests over the interests of alliances needed to address global health issues; and when it focuses on health as a political instrument rather than a human rights issue. there is growing recognition of the need to develop educational programs to prepare global health diplomats. u.s. secretary of state hillary rodham clinton called for the creation of a corps of civilian health diplomats who could contribute to the joint goals of diplomacy and international development by addressing problems related to health, food insecurity, environmental challenges, and challenges related to global warming (clinton, ) . hotez ( ) suggested that the core of health diplomats proposed by secretary clinton could make significant contributions to addressing the global health challenges posed by neglected tropical diseases that affect nearly all of the world's "bottom billion" citizens who live on less than $ per day. kerry, auld, and farmer ( ) described a specific proposal for an international health service corps (ihsc) to enhance local health capacity, similar to the health outreach programs that have been provided by cuba. interdisciplinary programs to prepare future global health diplomats should involve experts in fields such as foreign policy, academia, global health, epidemiology, health policy, economics, law, environmental science, and bioethics (kickbush, novotny, drager, silberschmidt, & alcazar, ; lemery, ; novotny, ) . barber, cohen, and rockswold ( ) also recommended training u.s. military personnel in strategies for collaboration with humanitarian organizations and local governments, strategies to promote sustainability, cross-cultural and historical sensitivity, and disaster response. adams, et al. ( ) summarized the goals of health diplomacy training programs, noting that "successful health development efforts have depended on functional and respectful relations among all the stakeholders, including donor and recipient governments, health care providers, local political leaders, and field-based ngos. a capable health diplomat must have a sophisticated understanding of the structures, programs, approaches, and pitfalls surrounding these relationships to achieve success, whether working in the clinical setting or at the policymaking table" (p. ). although no articles were identified specifically discussing global diplomacy content in nursing curricula, there are references related to addressing the general topic of global health in nursing curricula. bradbury-jones ( ) suggested that nurses have a global responsibility to address non-communicable diseases, as the leading cause of death worldwide, through work in health policy, research, education, and individual practice. archambault ( ) recommended that undergraduate nursing programs address the key global health concepts of global citizenship, social justice, health equity, and the determinants of health, and suggested that content should include: introduction to global health, global health goals, determinants of health, healthcare systems policy and politics, primary health care, global nursing issues, culture and, healthcare, epidemics, communicable and non-communicable diseases, epidemiology and health outcomes, and humanitarian emergencies. the association of faculties of medicine of canada (afmc) resource group on global health and the global health education consortium (ghec) proposed a set of global health competencies for medical students (association of faculties of medicine of canada reference group on global health and global health education consortium, ). wilson et al. ( wilson et al. ( , adapted these competencies for nurses, and surveyed nursing faculty in the u.s., canada, and latin america to identify their perceptions about whether the adapted competencies were appropriate for nurses. the competencies are divided into six broad categories: (a) global burden of disease; (b) health implications of travel, migration, and displacement; (c) social and environmental determinants of health; (d) globalization of health and healthcare; (e) healthcare in low resource settings; and (f) health as a human right and development resource. survey responses were received from nursing faculty members in the u.s. and canada and from nursing faculty in latin america, indicating general agreement that the competencies identified in these categories were important and appropriate for inclusion in nursing curricula. although there is a need for further research to refine and validate these competencies, the survey results can be used to guide development of curricula to prepare nurses to contribute to addressing global health problems. finally, the association for prevention teaching and research convened a healthy people curriculum task force consisting of representatives from eight health professional educational associations in order to promote achievement of healthy people objectives by integrating more content related to health promotion and disease prevention in curricula of the various health professions. the task force identified specific content related to global health that should be integrated into the curriculum (association for prevention teaching and research healthy people curriculum task force, ). the literature reviewed provides important guidance that can be used to develop interdisciplinary curricula to prepare nurses and other healthcare providers to develop competencies in global health and global health diplomacy. the estimated million nurses and midwives in the world make up the greatest proportion of the global health workforce (world health organization, a , b , and thus nurses could play a critical role in global health diplomacy initiatives if they were properly educated and prepared to be global healthcare providers and diplomats. since the time of florence nightingale, nurses have provided culturally appropriate healthcare in diverse global settings. they have been key participants in addressing global natural disasters such as the tsunami in thailand or the earthquake in haiti. global health diplomacy is an interdisciplinary academic field. global health diplomacy is guided by wisdom gained through experience and the ability to find mutually acceptable solutions to global health challenges. preparing nurses to contribute to global health diplomacy initiatives begins with the preparation of nurses as global citizens who are morally and ethically bound to understand and help individuals and groups at local, national, and global levels. in addition to building on initial efforts to identify global health competencies for nurses, research is needed to identify additional competencies necessary to prepare nurses as global health diplomats. there is a need for dialogue and discussion among leaders in diverse disciplines such as nursing, medicine, political sciences, social sciences, law, business, and economics to further define these competencies and develop curricula that will prepare future leaders both in global health and in global health diplomacy (lemery, ) . before nursing can support the concept of global health diplomacy as a dimension of this profession's global work, it is important to have a critical dialogue about the ethical and moral conflicts inherent in this concept e providing healthcare as a humanitarian responsibility versus using healthcare as an instrument of political activity. to begin such dialogue and promote further research to evaluate and refine the concept of global health diplomacy as a nursing phenomenon, the members of the aan epgnh task force on global health diplomacy in nursing endorse the definition of global health diplomacy proposed by adams, novotny, and leslie ( ) as "an emerging field that addresses the dual goals of improving global health and bettering international relations, particularly in conflict areas and in resource-poor environments" (p. ). further, the task force members believe that health diplomacy "is not only the job of diplomats or health leaders in government structures, it is a professional practice that should inform any group or individual with responsibility to conduct research, service, programs, or direct international health assistance between donor and recipient institutions" (novotny & adams, , p. ) . if healthcare and healthcare providers truly wish to make a difference in the health of the people of the world, then identifying the causes of health problems, finding solutions, and implementing interventions are required steps. global health diplomats must be prepared academically and experientially with astute negotiation skills; with collaboration skills to work with nations to protect health interests; with economic development acumen; epidemiological and research skills; and with diplomatic, economic, political, legal, medical, cultural, and conflict-resolution skills. there is need for further dialogue in the professional nursing community to identify nursing's role in global health diplomacy and identify competencies that should be global health diplomacy health security as a public health concept: a critical analysis oslo ministerial declarationdglobal health: a pressing foreign policy issue of our time incorporating global health into undergraduate nursing education. vancouver, british columbia: msn, university of british columbia. association for prevention teaching and research healthy people curriculum task force association of faculties of medicine of canada reference group on global health and global health education consortium diplomacy and medicine global health diplomacy: a call to action globalisation and its implications for health care and nursing practice editorial: medicine and diplomacy a healthier, safer, and more prosperous world: report of the csis commission on smart global health policy foreign policy and global public health: working together towards common goals leading through civilian power saving lives: universities transforming global health synthesizing research: a guide for literature reviews global health and foreign policy the globalization of public health: the first years of international health diplomacy unleashing ''civilian power'': a new american diplomacy through neglected tropical disease control, elimination, research, and development the u.s. commitment to global health: recommendations for the new administration u.s. commitment to global health: recommendations for the public and private sectors i defining health diplomacy: changing demands in the era of globalization diplomacy and the polio immunization boycott in northern nigeria an international service corps for healthean unconventional prescription for diplomacy global health diplomacy: the need for new perspectives, strategic approaches and skills in global health global health diplomacy: training across disciplines towards a common definition of global health framing health and foreign policy: lessons for global health diplomacy a case for white coat diplomacy us department of health and human services: a need for global health leadership in preparedness and health diplomacy global health diplomacy: a global health sciences working paper. university of california san francisco global health sciences financing of global health: tracking development assistance for health from certi: crisis and transition toolkit: how can health serve as a bridge to peace globalisation and health: the need for a global vision has aid for aids raised all health funding boats? united states department of health and human services the integrative review: updated methodology global health competencies for nurses in the americas. paper presented at the global health education consortium, cuerna vaca ), e . world health organization. what is health as a bridge for peace? the world health report : a safer future: global public health security in the st century in world health statistics key: cord- -drwvzw l authors: eyawo, oghenowede; viens, a. m. title: rethinking the central role of equity in the global governance of pandemic response date: - - journal: j bioeth inq doi: . /s - - - sha: doc_id: cord_uid: drwvzw l our initial response to covid- has been plagued by a series of failures—many of which have extended inequity within and across populations, especially in low- and middle-income countries. the global health governance of pandemic preparedness and response needs to move further away from the advocacy of a one-size-fits-all approach that tends to prioritize the interests of high-income countries towards a context-sensitive approach that gives equity a central role in guiding our pandemic preparedness and response strategies. while the global governance of pandemic preparedness and response often touts the importance of equity as a moral value and policy goal, our reaction to the covid- pandemic should lead us to call this into question. on the one hand, we find the failure of omission-the progression of the covid- crisis threatens to disproportionately impact low-and middle-income countries (lmics) with vulnerable healthcare systems. on the other hand, we find the failure of commission-high-income countries (hics) battle to buy out ventilators, personal protective equipment, and diagnostic tests on the global market, which freezes out any real possibility of lmics getting these resources. this lack of collective action is a moral failure that risks losing the gains made in promoting health and health equity globally, and risks calling into question the usefulness of equity-based arguments for responsible governance that were used to justify actions to achieve these gains. we argue that much of pandemic preparedness and response remains focused on the interests, resources, and capacities of hics and, in the case of covid- , requires more than a one-sizefits-all approach. the practicality of any proposed pandemic response measures needs to be strongly reconsidered in light of the flawed expectations surrounding the context, capacity, and governance arrangements in lmics. we maintain that this requires us to rethink how we can strengthen the role equity plays in guiding the global governance of pandemic preparedness and response, and its wider potential impact for global health governance more generally. it is widely accepted that equity is central to global health and should be the guiding principle in global efforts to improve the health and lives of all people around the world (fee and gonzalez ; plamondon and bisung ) . the current global response to covid- -which has been mostly inward looking and nationalistic-calls this premise into question. the global health governance response to the covid- pandemic has been largely modelled from the perspective of hics without due consideration for how and whether it provides a feasible parallel strategy for lmics. a predominant reliance on extemporaneous prevention measures, such as stay at home orders, frequent handwashing, long-term social distancing, and business closures cannot be easily or effectively translated into the lmic context without major political and economic changes. how can families in most lmics effectively implement social distancing and self-quarantine when they live together in close quarters and operate within a culture where mingling is the norm? it is a challenge at best and an impossibility in many cases. most people do not have access to running water at home; they need to go out into the community to fetch water from a public tap or stream-which makes regular handwashing challenging to implement. in some communities, there is no access to safe water at all-a problem that also disproportionately affects certain populations in hics, as evidenced by some indigenous and black communities in north america (waldron ) . many people also need to go to work in an informal setting on a daily basis in order to be able to afford food to eat the next day. they cannot so easily stock up on supplies and stay at home. many have no personal savings and live from hand to mouth, and there is no steady power supply to keep the fridge running, even if they somehow managed to fill it. furthermore, the food supply chain relies primarily on daily supplies and deliveries to local markets, since storage facilities are not very functional in these settings due to regular power interruptions. under a lockdown strategy with insufficient contingency plans including temporary income and an active supply chain, food supplies will run out quickly for families and communities. hunger will set in, crime may increase, and people may begin to die of starvation even before covid- or another disease gets them. this practical reality must be included at the forefront of our moral theorizing about the global ethical dimensions of covid- . decades of chronic health underfunding, largely driven by political corruption, has weakened the health system in most lmics. before the covid- pandemic, the healthcare systems in these settings were at best already fragile, vulnerable, and ill-equipped to mount a quick and efficient response proportionate to the magnitude of a pandemic such as covid- (viens and eyawo ) . while the experience with responding to ebola in some african countries may provide some clues on how to respond and mobilize, covid- is different, given its high transmissibility and mode of transmission. therefore, while the experience will be useful in these countries, it will not be sufficient to help them address this crisis. reports from early on in the pandemic suggested that the number of covid- cases in africa could surge to up to ten million in as little as six months (al jazeera and news agencies ). however, the reported figures so far appears to be much lower than projected (world health organization ); although this needs careful observation given the uncertain and evolving nature of the pandemic. to date, much of the focus on responding to covid- has been around the use of restrictive measures (i.e., quarantine, social distancing, school and business closures, travel restrictions) as the primary avenue to minimize or prevent community-level transmission. without an effective antiviral or vaccine, it is claimed, our best chance to save as many lives as possible and prevent healthcare systems from being overwhelmed is to lockdown society-encouraging or requiring everyone to stay home to prevent as much contact as possible, limiting trips outside of the home to essential work or to obtain essential supplies only. this strategy has been coupled with a push to increase the testing capacity and the number of covid- tests being conducted by local public health authorities in affected countries. while these measures have been the dominant approach in most hics, we should be sceptical of whether this will be an effective and feasible response for lmics, especially in africa. this is because little or no consideration has been placed on the unique challenges and opportunities in these settings-challenges that can impede the successful implementation of any response strategy. for instance, it is noteworthy that alongside the restrictive measures that include school and business closures to facilitate social distancing, most hics have created and rolled out a temporary income support benefit to its citizens and residents; something that most lmics do not have the capacity to do. canada, for example, which has an existing institutionalized unemployment insurance scheme, has set up a new response benefit to provide $ (cad) per month for up to four months to those who stopped work because of covid- (government of canada ). african countries cannot provide anywhere near the level of funding that is necessary to expect people to stop working and endure long periods of self-confinement. in comparison, some african countries have offered temporary covid- assistance in form of cash (in nigeria, , naira-approximately $ usd), food transfers, or unemployment insurance (as in south africa, the continent's most advanced economy) (dafuleya ; runciman ), amidst concerns that it may not reach the people that desperately need it (human rights watch ). this kind of palliative measure for staying at home is key to the successful implementation of such restrictive measures in any setting. the question is: will the economies in most lmics have the capacity to institute complementary income support measures for tax-paying workers who are part of the formal economy-at a level that is sufficient to support people during the extended lockdown? an even greater concern has to do with the fact that many individuals in lmics, particularly in africa, are either unemployed or are part of an informal economy where they are engaged as day labourers, handymen, petty traders, and local farmers/fishermen. these individuals live from hand to mouth and earn their living on a day-to-day basis as part of this informal economy. unlike hics, where the vast majority of residents are fully accounted for in the system and therefore a systematic rollout of support is feasible, most lmics will not be in a position to support such residents who rely on this informal economy and are unaccounted for in the system (akwagyiram and toyana ) . at the time of writing, nigeria, south africa, and kenya have already imposed a full or partial lockdown response strategy in its major cities. the majority of workers in the informal sector-which accounts for more than per cent of the workforce on the african continent-have been told to stay home (akwagyiram and toyana ) . most people are faced with the tragic and stark choice of either staying at home and risking starvation or going out to work and risking infecting themselves and their loved ones. these issues are further compounded by a confluence of other factors resulting from contextual features that render this situation an unmitigated disaster with massive moral implications: an increase in crime and social disobedience; oppressive regimes using the pandemic as an opportunity to further clamp down on dissenters; citizens unable to collect any of the government's meagre pandemic assistance because of a lack of bank or mobile money accounts; already weak health systems at risk of collapse; and food becoming expensive and scarce during lockdowns, especially since there is no government oversight or control against price gouging. unsurprisingly, poverty is strongly associated with hunger in africa, with sub-saharan african countries already having the highest levels of hunger and undernutrition of all the lmics, which leads to childhood wasting and stunting, higher risk of illness, poor physical and cognitive development, and high mortality rates (klaus et al. ; otekunrin et al. ) . the arrival of covid- and the fact that it will exacerbate hunger and poverty provide the potential for this to be a real humanitarian catastrophe that morally requires urgent attention. according to the africa centres for disease control and prevention, it has been difficult for many african countries to scale up their testing programs in response to covid- (nkengasong ) . while in some cases this stems from not having the technical capacity, a major reason is that these countries are having trouble securing the chemical reagents needed to process tests. since africa does not currently produce their own testing reagents, they need to compete on the world market against hics for this crucial, yet limited, material. africa has not been able to get into the market to get muchneeded diagnostics due to global protectionism-over seventy countries have imposed restrictions on export of essential diagnostic supplies. given the established supply chains and purchasing power of hics, their ability to buy up most of the supplies prevents african countries from taking essential steps to protect themselves from covid- . according to john nkengasong, director of africa's centres for disease control, "the collapse of global co-operation and a failure of international solidarity has shoved africa out of the diagnostics market" (nkengasong ) . in these contexts, where it is not lack of capacity or resources that is the source of the harm but the actions of hics, we find one of many illustrations of where hics are violating their justice-based duties not to unduly harm others by participating in institutions and taking individual actions that have a causal role in the generation and persistence of ill health and health inequality (pogge ) . we have a general moral duty not to cause harm to others; and where we are causally implicated in the commission of that harm, we have a specific moral duty as a matter of justice to alleviate the harm that we have contributed to. these illustrations reinforce the need to revise the structure and function of global health governance systems so as to eliminate the disproportionate and exploitative power relations that have led to the current state of global health and health inequalities. covid- provides an opportunity to reset the structure, function, and aims of global health governance. as far and wide as possible, we should take this opportunity to reinvigorate and re-establish an approach to global health governance with a true central focus on equity. there are a few ways within the global governance of covid- response and global health governance more generally to bring equity back as a central component: & strengthen collective action and global cooperation to assure the conditions in which people can be healthy (e.g., universal health coverage, wage subsidies so people can stay home) & reduce the dominant focus on individual responsibility for health (washing hands, staying home from work, etc.) and focus on how structural factors act as social determinants of health & enhance coordination of response activities so that the actions of hics do not prevent the ability of lmics to promote health and reduce health inequities (e.g., at least prevent hoarding by hics once sars-cov- vaccines start rolling out and at best coordinate global distribution to ensure affordable access for everyone) & develop structures and mechanisms that allow for the prioritization of local response and control in the global response to pandemics and other global health threats & hics should not be completely self-protectionist in orientation when responding to pandemics (e.g., while the united states sought to defund/leave the world health organization, canada increased its foreign aid budget) we believe that the current approach to pandemic preparedness and response-one that is overly driven by the interests, resources, and capacities of hicsundermines the central role of equity in global health and limits our collective ability to effectively address important global health challenges-which as covid- has reminded us, does not respect borders or social status. we argue that our approach to global health governance must equally consider the context and capacity in hics and lmics alike. strengthening the role of equity in guiding the global governance of pandemic response is a sine qua non if we truly want to successfully confront current and future global health challenges. lockdowns: saving lives, but ruining livelihoods in africa africa coronavirus cases could hit million in six months: who explainer: why covid- provides a lesson for africa to fund social assistance. the conversation government of canada. . canada's covid- economic response plan: support for individuals nigeria: protect most vulnerable in covid- response global hunger index: africa edition let africa into the market for covid- diagnostics how far has africa gone in achieving the zero hunger target? evidence from nigeria the ccghr principles for global health research: centering equity in research, knowledge translation, and practice world poverty and human rights gaps in south africa's relief scheme leave some workers with no income. the conversation covid- : the rude awakening for the political elite in low-and middle-income countries there's something in the water: environmental racism in indigenous and black communities coronavirus disease (covid- ) situation report - publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -kq gru c authors: aryal, shreyashi; pant, sagun ballav title: maternal mental health in nepal and its prioritization during covid- pandemic: missing the obvious date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: kq gru c nan this is a pdf file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. this version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. dear sir, covid- pandemic has taken a toll on all health services and reproductive health has also been bearing its brunt. there should be no divided opinion that psychiatry is related to covid- and more so in asian countries due to their political and economic vulnerabilities (tandon, ) . under-prioritization of womens' psychiatric issue at these times would be missing the obvious. nepal has a high maternal mortality ratio of deaths per , live births (ndhs, ), due to which safe motherhood, contraception and abortion have always been a priority despite having an impoverished health system. on the other hand, mental health issues of women which j o u r n a l p r e -p r o o f is also burgeoning but under-acclaimed problem, is under-researched and grossly overlooked (regmi et al., ) . reproductive health and mental health are interwoven and a complete well being cannot be obtained without their integration. the first witnessed covid related death in nepal was a young woman in her postpartum period and this has paramountly increased the stress that millions of pregnant women are currently facing. mental health in pregnancy and puerperium is not addressed to the extent of its necessity and this pandemic has increased the ever present gap in maternal mental health issues. nepal has just above % institutional deliveries and this pandemic may force women to go back screening for maternal mental health issues is a low priority in nepal and addressing this issue should be a priority now than ever before. when the focus is in covid positive cases, policies to detect early signs of mental illnesses which are increasing in non covid women also have to be formulated. culturally validated screening tools can be used for all antenatal care packages, and question on suicidality must be accessed. a liaison plan should be made with the involvement of mental health service providers to identify antenatal and postnatal psychiatric issues during hospital stay. video conferencing for antenatal care and tele-psychiatry can be a cost effective method for screening, evaluation and management of pregnancy in nepalese context, where there is scarcity of health professionals. but these may not always be feasible due to low literacy rate especially in rural areas. mobilization of female community health volunteers at the community level, to detect pregnancy at risk including mental illness can be continued while maintaining rules of physical distancing. obstetrics is one clinical subject where continuity of care is inevitable. pregnancy and labor cannot wait and along with this comes mental health care. this is the time when women need to exercise their reproductive rights more than ever before and obstetric service providers play a pivotal role in ascertaining that they are able to do so. we need to make sure that these women go through a pleasant birth experience through the integration of physical and mental health. the crisis may always remain, so living with it with essential precautions, innovations and improvisations is the only option. the covid- pandemic personal reflections on editorial responsibility psychiatric caseness and its obstetric correlates in pregnant population attending antenatal clinic in tuth potential maternal and infant outcomes from coronavirus -ncov (sars-cov- ) infecting pregnant women: lessons from sars, mers, and other human coronavirus infections pregnant algeria doctor who was denied maternity leaves dies of coronavirus why are so many nepali women killing themselves? a review of key issues reproductive health issues and depression in wives of labor migrant workers from the frontline of covid- -how prepared are we as obstetricians: a commentary a new covid- crisis: domestic abuse rises worldwide. the new york times key: cord- -idel l authors: mellor, nicholas; horton, hetty; luke, david; meadows, jon; chatterjee, arunangsu; gale, thomas title: experience of using simulation technology and analytics during the ebola crisis to empower frontline health workers and improve the integrity of public health systems date: - - journal: procedia engineering doi: . /j.proeng. . . sha: doc_id: cord_uid: idel l abstract the ebola outbreak highlighted the challenge of health security and particularly of how best to give frontline workers the knowledge, confidence and competence to respond effectively. the goal was to develop a tool to improve infection prevention and control through local capacity building within the context of an emergency response. the research showed that digital technology could be a powerful ‘force multiplier’ allowing much greater access to high fidelity training during an outbreak and keeping it current as protocols evolved or new safety critical steps were identified. tailoring training to the local context was crucial to its relevance and accessibility. this initiative used a novel approach to the development of the training tool – ebuddi. it used agile development to co-create the tool with active participation of local communities. a further pilot showed how it could be extended to meet the longer term needs of triage training and ensure better quality assurance. in the longer term it may have the potential to improve compliance with international health regulations, be adapted for future emergencies, and contribute to global health security. the recent ebola outbreak highlighted four key areas of concern in health security. firstly, it focused attention on the importance of infection prevention and control (ipc) competence and compliance amongst frontline workers in a region as large and remote as west africa. secondly, training needed to be accessible to a wide range of people be they working in healthcare and the laboratory sectors or burial teams and maintenance staff -all with large variations in skills, knowledge and education levels [ ] . these workers, whether they were professionals or volunteers, needed access to training to keep themselves, their patients, colleagues and families safe. thirdly, community engagement was vital in controlling the outbreak. finally, the need to be prepared for novel and new pathogens such as middle east respiratory syndrome coronavirus (mers-cov), severe acute respiratory syndrome coronavirus (sars-cov) and other strains showing resistance to anti-microbials. ebola was not a one off -there will be constant challenges of this nature, requiring healthcare systems to be more resilient, watchful and responsive than ever before. there are important messages to learn about health security from the ebola response, both in the west african region and globally. even highly trained international health workers lacked skills in the use of personal protective equipment (ppe) which lead to high profile cases of infection. these observations imply a problem with how such epidemics are handled and without a change in attitude and approach; similar issues could resurface in the next outbreak, as illustrated by the challenge of dealing with the endemic lassa fever in the same region [ ] . in his article, 'the next epidemic -lessons from ebola', bill gates emphasised the need for better and faster training for health personnel to confront and contain an epidemic quickly [ ] . he is not the only figure to draw attention to training on a global stage. multiple reviews reflect lessons learnt from community empowerment and giving the frontline the tools, knowledge and competences to contain the outbreak [ , ] . this a lesson for all countries as highlighted by the efn report on eu health professionals' perceptions of preparedness for ebola and infectious diseases of high consequence (idhc) 'we are not prepared unless we are all prepared' [ ] . in addition there was the recognition of the importance of innovation and finding smarter ways of responding, but most initiatives struggled to realise their full potential [ , , ] . simulated training can 'bring learning alive' and increase engagement levels [ ] . it encourages teamwork, in particular the role of the buddy, which is vital in situations where ppe is required. the digital nature facilitates a network-based approach to distribution allowing tight version control and replication across communities, districts, countries and potentially continents [ , ] . it helps shift training from a classroom based, didactic style delivered by an international expert to a more peer based, personalised approach that overcomes some of the constraints inherent with a centralised, cascade based approach to rolling out new training. this article presents a model that could transform ipc training. it blends traditional training with tablets to create a technologyenhanced approach that aims to improve patient and health worker safety. the system, known as ebuddi, has been prototyped in west africa and has the potential to improve quality, accessibility, scalability and legacy of training [ , ] . this novel approach has attracted international attention and it could be used to improve health systems resilience and outbreak response worldwide. creating the ebuddi prototype was a collaborative approach between organisations with frontline operational capacity and specialists in medical education, training and agile software development. the masanga mentor ebola initiative (mmei) comprised the masanga hospital in sierra leone, the mentor initiative and experts from merlin's lassa fever programme. plymouth university peninsula schools of medicine and dentistry (pupsmd) were involved throughout providing input based on pedagogical principles and best practice in virtual learning and distributed simulation. the core concepts were based on national guidelines and ipc curriculum developed by the liberian ministry of health in association with the who and cdc. these were applied to pedagogical mechanics from game based learning and used agile development to interpret them with graphical user interface (gui), animation and language [ ] . initial prototypes were built from videos with who expert trainers and photos of the healthcare settings, and evolved through co-creation and agile development. co-creation by experts and frontline trainers produced an authentic module that engaged the audience more than passive illustrations portrayed in textbooks or demonstrations by international experts alone. agile development meant that frontline trainers and healthcare workers could feedback to the international development team and see their involvement included in subsequent builds. initially the development involved input from diaspora groups able to meet directly with the development team in london. however as communications links were put in place with operational training teams on the ground, input to the development team could be provided directly from those in the frontline -ensuring even greater authenticity and relevance of the training material to the safety critical steps. fig. illustrates this continuous loop of communications between the in-field metrics and international development teams exchanging module iterations with data to improve technical performance and learning impact. the quicker this feedback was incorporated, the more impact it had on subsequent suggestions as trainers were encouraged to see the value of their ideas, encouraging bottom up innovation. open innovation and collaboration make digital approaches to learning more accessible and affordable. for such technologybased initiatives, insights such as the principles for digital development act as 'living guidelines that can help development practitioners integrate established best practices into technology-enabled programs' [ ] . considering an open approach to technology-enabled international development would encourage a free flow of ideas that permeate organizational boundaries, not waste public resources unlocking code and duplicating work. the principles guide strategies for leveraging and contributing to broader resources and knowledge to give greater impact. with these guidelines, we can make a more concerted effort to institutionalise the many hard lessons learned in the use of information and communication technologies in development projects [ ] . the field trials comprised quantitative and qualitative studies to investigate the value of ebuddi. they introduced the concept of ipc and ppe, as well as the effectiveness of trainers, to healthcare workers both during the acute phase of the emergency and the subsequent transition into restoring essential healthcare. the training tool was developed by immerse learning, pupsmd and total monkery, and a team of experts led by jon meadows. fieldwork was conducted by masanga hospital and the mentor initiative; supported by expertise at pupsmd. the training team comprised ipc specialists within the mentor initiative who, during the course of the studies, visited over one hundred health facilities. the majority of these facilities were private health clinics and health centres, in addition to three hospitals and one ebola treatment unit (etu). facilities covered both urban and rural areas. close to five hundred healthcare workers were introduced to the tool during the study. the fieldwork comprised four main phases: phase : introducing the concept. early prototypes developed by immerse learning were introduced to healthcare workers in sierra leone. feedback confirmed that the tool was relevant and appropriate for training healthcare workers and supported the model which incorporated training in both english and local language. phase : testing potential. conducted in health facilities in liberia to test the potential of the program. small groups used ebuddi and gave informal feedback and first impressions. it was tested as a standalone tool where participants used the module on a laptop for approximately one hour, independent of scheduled training, and evaluated confidence levels before and after. phase : testing efficacy. the study used rapid and agile feedback mechanisms to accelerate development and prioritize local input. each participant evaluated their confidence with ipc practices and then was assessed on their competence at donning and doffing enhanced ppe. ebuddi was used to reinforce the practical experience and then the participant was reassessed on their practical skills. quantitative data collection identified trends and performances. phase : operational value. this phase focused on how best to apply ebuddi in different contexts -targeting end users with a range of resources and abilities. field trials integrated ebuddi into scheduled group ipc training, focusing on ppe training. the program was used alongside practical demonstrations and skill stations, continuously adapting to meet changing resources. the studies gave a real insight into the concept of ebuddi -how it might be best used in the field and its potential as a teaching tool to support traditional training methods. there were many positive attitudes across the different stakeholders shown in fig. , although the multiplicity of stakeholders meant that building a coherent base of support was often a slow process given their different perspectives and priorities when it came to training. the initial feedback was encouraging and people enjoyed the concept. however, most users had minimal experience with laptop technology and initially required constant guidance from the trainer on how to operate the module, especially on the first run. the unfamiliarity of the target audience with computers meant that many users struggled to use a mouse. this contrasted with their confident use of smartphone technology and touch screen interfaces. west africa has seen technology leapfrog from minimal use of social media and connectivity to rapid adoption of to smartphones and use of tablets, without following the evolutionary path through desktops and laptops. this meant that agencies outside the region often underestimated the utility of digital tools or were constrained by the belief that custom low cost hardware would be necessary to ensure the broadest possible update of such tools. introducing tablets enhanced trainee engagement as well as gui intuitiveness. with the ever-increasing prevalence of smart phones, a touch screen interaface was found to be more and more accessible. this shifted the study focus from laptops to android based tablets due to their size, relatively low power consumption and usability. the intuitiveness of the module and the familiarity of the graphics were important. unknown objects in the background distracted users from the key messages from the program, so the study worked alongside liberian trainers to design a setting that was familiar to end users. including local voiceover (language and dialect) increased understanding. software developers focused on making the module as intuitive and graphical as possible, recognising that some target users are illiterate, let alone computer literate. initial wariness to foreign schemes pervaded the communities throughout the emergency response but this authenticity, as well as trust in the local training teams, helped overcome this challenge. the close involvement of sierra leonean and liberian experts ensured a more authentic tone and familiar setting to the content being developed. testing ran concurrent to software development. daily updates facilitated rapid feedback direct to developers, made possible through digital communications and the adaptability of the simulation environment compared with video based training materials. it was important to value and input suggestions from frontline trainers, and agile development allowed this to happen quickly. once trainers could see their suggestions incorporated into new versions, it encouraged further feedback and a sense of co-creation -a virtuous circle of engagement. however, this process was not without its challenges -from the most basic access to sufficient connectivity for conference calling, through to information management and prioritisation of development recommendations. a key lesson learned was the need to communicate clearly to the front line healthcare workers about what development would be enhanced for the next app release. their expectation of instant and specific modifications from their personal recommendations grew quickly and at times to an unrealistic level. the training had to be flexible and adapt to changing resources, including time constraints, staff availability, limited equipment and power management. the advantage of ebuddi was that as modules were developed they could be added as additional posters in the simulated clinic, as shown in fig. . in the end, this would allow trainers to pick and choose the topics they needed according to their local priorities. the initial ebuddi module evolved to respond to the changing training needs in liberia. its teaching responded to changes in the national guidelines that shifted focus from specific ebola material to generic ipc in health facilities -from the 'keep safe keep serving' curriculum to the 'sqs' curriculum [ , ] . the liberia specific module developed is currently being adapted for training in standard precautions and ipc in sierra leone to build resilience post ebola as part of the icare project, funded by the department for international development uk. agile development has enabled the core modules to be adapted to this changing focus. this was a good indication of how the program could adapt to new material, something that the modular approach helped significantly. the studies demonstrated the value of near peer learning when introducing new concepts. collaboration and teamwork were important and emphasised in the conversations during the introduction of the blended approach to learning. this immediate feedback identified areas where training needed to be reinforced to avoid common or dangerous mistakes. some unexpected findings came out of the fieldwork combining digital technology with peer learning in austere environments. in one example a nurse, who was confident with ipc was struggling to use a tablet. she was helped by a nurse aid who was more computer literate yet did not know much ipc. this collaborative approach to learning between the trainees was insightful and very encouraging to watch. inbuilt data collection was trialled in the latter stages of the fieldwork. the module introduced a personalised user record that tracked which topics had been covered and the scores achieved in each competency. users liked to know their scores and progress through the module and so the data collected could be used for personal feedback as well as wider progress tracking. it could facilitate targeted coaching to individuals and also more novel outreach functionality, for example, if a key module was overlooked, it would be flagged and the coordinator could remind the trainer responsible for that facility. the field trials in west africa tested the ebuddi prototype and explored its potential in different and challenging environments. it began to address some of key concerns in health security raised from the lessons learnt from the ebola response -focusing on improving outcomes in skill improvement not just outputs of number of health workers trained. the importance of ipc in such outbreaks is undeniable. frontline workers need frequent, high quality training that is accessible to all and independent of location and education level. it needs to adapt to changing resources such as available equipment and how to respond to shortages, introduction of new equipment, procedural change and learning from incidents that might have resulted when critical safety steps have not been fully understood. the training needs to adhere to local policies and protocols. this is captured in the ebuddi development process by a compliance document that details local guidance and captures key learning, critical steps and evaluation points. the field trials showcased the potential of ebuddi to augment existing ipc training in liberia, which has contributed to the success of stopping the outbreak. true behavior change of health care workers is difficult to ensure as adherence to standard protocols can wane quickly when the acute threat of infection is deemed to have reduced. the second key concern is that everyone must have access to required knowledge and skills to work with confidence and competence, a philosophy enshrined in the efn report 'we are not prepared unless we are all prepared' [ ] . ebuddi seemed to increase the confidence of healthcare workers in the short term, although the long term benefits require further research. a key finding from the fieldwork was that the graphics needed to be familiar to the trainee -including the design of the health facility, equipment available and surrounding landscape (rural or urban). the addition of a local soundscape further increases the immersive nature of the learning experience. increased usability of the module developed from feedback, engaged a wide audience regardless of skills, knowledge or education levels. community engagement is vital in controlling an outbreak such as ebola. the co-creation model of ebuddi empowers frontline workers and trainers to give valued feedback and critically be able to see their input in the module. this ensured authenticity and buy in to any subsequent development. the avatar characteristics can be changed to reflect an appropriate mix of gender, ethnicity and culturally appropriate clothing. this gives the module great potential to relate to different communities and demographics, and recognise the importance of highlighting the key role women play in the response by highlighting this in the simulation exercises [ ] . preparedness for fresh outbreaks from existing pathogens such as ebola or lassa fever or emerging pathogens such as middle east respiratory syndrome (mers) is important. this is where the agile development of ebuddi can really rise to the challenge as it has the potential to respond quickly and accurately to an outbreak with international experts co-creating training with local community actors. using analytics and data to collect information and statistics can be used to identify trends, gaps through automated monitoring, and evaluation of an outbreak much faster and at higher integrity than before. ebuddi could ensure frontline health workers have the right kind of training in time, acting as an aid to programme management of resources, as well as provide direct support to health trainers carrying out each session. there was scepticism whether such research could be carried out during an emergency. some frontline agencies saw a technology-based approach as an additional complication, cost factor or constraint in training programmes. however, the mmei partnership illustrated the capacity of small organisations or alliances to be more responsive and innovate more easily than larger, more bureaucratic organisations -although they often face challenges in getting support from donor agencies who often prefer to support well established implementing partners with whom they have an existing relationship [ ] . in the field of health research the main focus has been on therapies, vaccines and equipment where there are good precedents of public private sector partnerships leading to tangible products. there are fewer precedents in the digital field possibly leading to less appreciation in the emergency sector of how significant such technology could be in re-imagining capacity building. the business sector has already seen how digital simulation technology can be delivered on multiple platforms where laptops, tablets and mobile phones could all provide an opportunity to teach and train; and the growing trend for people to bring their own device (byod) to the training session. every crisis is an opportunity to innovate, build on lessons learnt and share new sights and better practices more widely. the importance of doing this was recognised in the european summit meeting on lessons learnt from the ebola response which concluded that successful innovations from the recent ebola response need to be built on to create 'a smarter, more scalable and sustainable' response capability in the future [ ] . the wilton park meeting ( ) on empowering frontline health workers concluded: 'this is a moment in time. the last years have seen a revolution in ict and mobile technologies. ebola shone a spotlight on the ineffectiveness of past health systems strengthening efforts; there is growing evidence that ict and mobile are a vital part of the solution to build resilient health systems.' [ ] . the field trails demonstrated that it was possible to innovate in an emergency response setting. it had many challenges and it was important to reduce the burden of the technology where possible. nonetheless, the benefits of the analytics and the inbuilt monitoring and evaluation could, in the long run, make the data collection process much less burdensome. ebuddi was designed to provide a legacy to the ebola outbreak -an expert training aid with the potential to be adapted as practice, protocols and equipment evolved. right from the start it aimed to improve the emergency response and to leave a legacy that would help to ensure a higher standard of training after the emergency was over. the transition from a conventional training model to a blended or technology enhanced model is often difficult, but if this path can be successfully navigated then mmei's research demonstrated many benefits of using digital technology for training in an outbreak response. these include using a standardised training format to promote key safety protocols and the ability to detect lack of knowledge and skills through analytics embedded in the tool. the use of tablet devices proved transformational compared with early trials that used laptop computers -in particular the usability of the interface, their intuitiveness and lower power consumption. bringing together the expertise and resources for an effective blended learning programme required a breadth of skills and investment beyond any single organisation. the mmei partnership not only was able to draw together such competences but also benefit from the insight and expertise of a wide range of volunteers from a wide range of specialities, sectors and countries around the world keen to contribute to the fight against ebola. ebuddi could assist a coherent approach to evaluating outbreak response competences such as the standards for outbreak response set by the international health regulations (ihr) [ ] . the ihr represents the agreement between countries including all who member states to work together for global health security and stipulates that each country needs a human resource development plan to address the gaps existing between the knowledge and skills required to comply with ihr requirements and the knowledge and skills available in the workforce. currently compliance with ihr is often difficult to assess. longer term, the ebuddi model could be adapted to other regions and public health contexts where there is a need to boost local understanding of infection, prevention and control as well as personal and patient safety. the adaption process would require alterations across three areas -protocol adherence, graphical interface and avatar characteristics. the architecture of the code underlying the module has been built in a way which allows continual development. the advanced analytics could enable real-time tracking and monitoring of the training impact. it could be used to improve training in real time, offering quality assurance to trainers and project managers on the ground through automatic monitoring and evaluation, thereby improving the integrity of the public health training programme. the analytics may be presented on an individual basis, of a training group, within a community, district, national or international level. on a wider stage, data provides a greater level of transparency for donors and other sponsoring agencies. analytics will ensure continuous improvement, building the evidence base to support future deployment as well as being a catalyst to continuing innovation. as the tool matures, ebuddi may be able to provide high quality training in hard to reach places, recognising the physical constraints of movement during a public health crisis, geographical inaccessibility, or the threat of insecurity. the study has shown ebuddi could enhance conventional approaches to local capacity building by improving training effectiveness, increasing cost efficiency when scaled and enabling an agile response to changing priorities. ebola -what went wrong? london. the lancet global health blog lassa fever update the next epidemic -lessons from ebola. usa a community-engaged infection prevention and control approach to ebola. health promotion international community-centered responses to ebola in urban liberia: the view from below we are not prepared unless we are all prepared' eu health professionals' perceptions of preparedness for ebola and infectious diseases of high consequence one year into the ebola epidemic. world health organisation case study: innovations in emergency disease responses. centre for research in innovation management (centrim) what we've learned about fighting ebola virtual learning and distributed simulation (v-lads) for preparing healthcare workers at peripheral health units to protect themselves against ebola virus disease (evd) in west africa advancing today's training and tomorrow's outbreak preparedness: the importance of innovation a networked approach to improving the resilience of communities confronted by the threat of ebola. london. the lancet global health blog health worker focused distributed simulation for improving capability of health systems in liberia. simulation in healthcare digital development principles working group. the principles for digital development ebola virus disease (evd) infection prevention and control standard operating procedures (sop) for health clinics, health centers and hospitals liberia ministry of health ipc task force the psychosocial aspects of a deadly epidemic -women in the ebola crisis: response and recommendations from un women conference: lessons learned for public health from the ebola outbreak in west africa -how to improve preparedness and response in the eu for future outbreaks re)building health systems in west africa: what role for ict and mobile technologies? (wp ) strengthening health security by implementing the international health regulations. geneva. world health organisation the authors are grateful to the following partners, contributors and organisations for their continued help and support through this programme: the telegraph christmas appeal, richard allan, geoff eaton, elton gbollie, dr simon mardel, dr jurre van kesteren, dr bart waalewijn, dr austin hunt, richard scott and the ipc team in the the mentor initiative -liberia programme. key: cord- - nkrrqqw authors: patrick, jennifer r.; shaban, ramon z.; fitzgerald, gerry title: influenza: critique of the contemporary challenges for pandemic planning, prevention, control, and treatment in emergency health services date: - - journal: australas emerg nurs j doi: . /j.aenj. . . sha: doc_id: cord_uid: nkrrqqw the h( )n( ) influenza pandemic was a major challenge to health services around the world. previous experiences with severe acute respiratory syndrome (sars) and avian influenza a (h n ) prompted initiation of formal pandemic planning. essential and desirable features of pandemic plans include preparation for surveillance, investigation of cases, treatment modalities, prevention of community spread, maintenance of essential services, research and evaluation, and implementation, testing and revision of the plan. the experience of h( )n( ) influenza pandemic for emergency departments and their staff was problematic. the pace of the pandemic, coupled with untested pandemic plans, presented a unique range of challenges. in this paper, the contemporary challenges with respect to pandemic influenza prevention, control, and treatment are examined. the lessons learned are critical to our response to future pandemics, which are inevitable. the experience with severe acute respiratory syndrome (sars) and avian influenza a (h n ), as well as knowledge of influenza pandemics last century, prompted initiation of formal pandemic planning. pandemics evolve rapidly, and are complex and unpredictable. in , after the sars experience, the world health organization (who) identified the essential and desirable features of pandemic plans, which included: (i) preparation for surveillance; (ii) investigation of cases; (iii) treatment modalities; (iv) prevention of community spread; (v) maintenance of essential services; (vi) research and evaluation, and implementation; and (vii) testing and revision of the plan. this paper will critique the current literature with respect to contemporary challenges for pandemic influenza prevention, control and treatment. influenza viruses are myxoviruses, with three main genera, influenza a, b and c, which are capable of causing infection in humans. , only influenza a causes epidemics or pandemics in humans. , one antigen (haemagglutinin or h) on the outer coat of the virus anchors the virus to cells, and another (neuraminidase or n) helps it both enter and exit cells. influenza a subtypes are named according to which subtypes of h and n they possess. these antigens alter over time by a process of drift, or repeated minor mutations that occur over time, or shift, or major change in the antigens, which occurs when two different influenza viruses are simultaneously in a host and recombine. [ ] [ ] [ ] [ ] influenza may be transmitted by aerosols, large droplets, and direct and indirect contact. the relative importance of these modes is considered debatable. the virus can survive on non-porous surfaces for up to h and on unwashed hands for min. both seasonal and pandemic h n influenza outbreaks failed to demonstrate significant airborne transmission over long distances, but aerosol transmission may occur in confined spaces, especially when a large airborne infectious burden is present. , what is pandemic influenza, and what is the difference between it and seasonal influenza the who and the department of health and ageing (doha) state an epidemic occurs when there are more cases of a disease than is normal and a pandemic is declared when a worldwide epidemic occurs. , the who monitors influenza globally and is the body that declares the commencement and end of pandemics. influenza pandemics occur when a virus to which people have little or no immunity develops, and efficient human-to-human transmission exists. , pandemics may persist for months, years or decades, have rapid transmission, disease occurrence is outside usual seasonal patterns, and attack and mortality rates across age groups are unpredictable. the declaration of a 'pandemic influenza' has major effects on resource allocation within government and non-government health agencies. it also has profound effects in the function of societies, including disruption and closure of schools and workplaces, as well as restrictions on travel and social gatherings. however, the criteria by which an outbreak of an infectious disease may be declared a pandemic are neither fixed nor well defined. , they depend on a variety of factors including the relative incidence of an outbreak across jurisdictions, the severity of the infection, and cross-border or transnational cooperation with respect to the epidemiology of the disease. if a pandemic is defined merely by the spread of a new influenza virus strain around the world, the effects of having the formal declaration in place may disproportionately affect the function of society in the event of a mild illness. criteria also need to be developed for declaring a pandemic 'over'. in the case of pandemic h n , countries around the world ceased epidemiological tracking of the infection when it became ubiquitous. thus there is a need to establish international consensus on the formal definition and criteria for pandemic influenza to allow appropriate response to an outbreak, and to determine when declarations of pandemic may be lifted. pandemic plans require large-scale surge capacity in healthcare systems and the community. surge capacity is the ability to manage a sudden, unexpected increase in patient volume (i.e., numbers of patients) that would otherwise severely challenge or exceed the current capacity. pandemics have health, economic, political, and social impacts. , internationally, healthcare systems have few surplus resources. a us study identified that regardless of planning, few health services had staff, equipment, and facilities to implement them. there is no reason to believe that australia was in any better case. in australia, doha developed the australian health management plan for pandemic influenza (ahmppi) which was tested though exercise cumpston in and exercise sustain in . australian jurisdictional plans complement and augment the ahmppi. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] exercise cumpston gave recommendations on the ahmppi. these included calling for streamlined decision making processes, flexible response according to disease severity and local resources, improved communications, public health education, a national surveillance framework, clarification of quarantine, border control, and emergency legislation, and involvement of primary care providers in planning. two years later, exercise sustain identified the differences between pandemic and disaster responses, and stressed the impossibility to plan for all eventualities given the unpredictability of new viruses. it addressed local community empowerment, recommending planning with community leaders and groups. social distancing was identified as an important prevention strategy. development of a productive relationship between the media and public health agencies, with an emphasis on timeliness, transparency, and honesty was explored, with health professionals considered to have most credibility for message delivery. australian state and territory pandemic plans additionally recommend the establishment of flu clinics, separate influenza triage, and designated 'flu hospitals' to facilitate quarantine and allow eds and general practitioners to maintain their core business. these plans aimed for staff protection, including priority vaccination for at-risk staff, pre-and post-exposure prophylaxis, the use of personal protective equipment and access to pandemic stockpiles, with those exposed or ill expected to self-isolate. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] other identified needs include extra funding, pre-defined triggers for plan implementation and deactivation, anticipatory training of key personnel and suspension of non-essential and/or non-emergency hospital functions during the crisis. ventilators, medications and personal protective equipment were to be stockpiled. increased cleaning, security and crowd management capacity was identified in the plans, along with the need to increase morgue and laboratory capacity. more non-medical staff are required for administration, communication, transportation, security, cleaning and garbage disposal, and for crowd control. surge capacity applies across the entire community, with health, government and community groups required to act cooperatively. when individual hospitals reach capacity they need to have means to move patients and/or services to other hospitals or centres. [ ] [ ] [ ] healthcare worker illness needs to be planned for with use of agency, retired staff, and volunteers. seasonal influenza seasons have highlighted a lack of surge capacity in emergency departments (eds). the literature shows that pandemic planning and management are complex, expensive and difficult. in spite of exercises cumpston and sustain , australian pandemic plans were criticised during the h n influenza pandemic for most of the reasons identified as problematic during those exercises. [ ] [ ] [ ] remedying these problems goes beyond their recognition, and requires sustained and systematic investment on the part of government, the health system, health professionals, and the general public. overwhelming evidence exists that it is not possible to prevent pandemics, and when they occur they can cause substantial morbidity, mortality and social disruption. , when the h n influenza isolate was identified in mexico, their borders were closed at great economic cost to the country. however, the virus had already spread. air travel allows rapid and efficient spread during the incubation period when people are asymptomatic, rendering border closure and controls such as thermal scanning inefficient as a means of prevention. surveillance, identifying the onset, nature and size of the outbreak and populations affected is fundamental to pandemic control, identifying spread and trends, determining at-risk populations, allowing for targeted interventions, and monitoring of their effectiveness. surveillance of influenza-like illness (ili) in mexico allowed for identification and early warning of pandemic h n influenza , although there can be little doubt that the virus was circulating for some months prior to formal identification. it is difficult to clinically differentiate patients with influenza from those with other viral respiratory infections. rapid antigen point-of-care testing, was shown to have low accuracy for known pandemic h n influenza , and reverse transcriptase polymerase chain reaction (rt-pcr) provided the best method of testing. obligatory testing of all with respiratory disease ceased during the sustain phase of the pandemic, as positive diagnosis would not change treatment or isolation, and it would have been a pointless expense to keep testing. the literature shows testing was problematic and expensive. immunisation is a primary tool for pandemic influenza control, however it takes time to develop and manufacture vaccines. , in the interim, community mitigation strategies including social distancing, cough and sneeze etiquette, and frequent thorough hand hygiene may be used. , atrisk groups need targeted information and intervention. contact tracing of healthcare worker and patients' contacts has been recommended to identify those with risk factors for severe disease who may benefit from antiviral prophylaxis. a recent study in australia of the knowledge and attitudes the general public held towards pandemic h n influenza found low levels of public anxiety, a high degree of belief in government preparedness, vaccination and quarantine as effective public health measures, antiviral medication as moderately effective, and a low level of belief in hand hygiene as a preventative measure. quarantine was cited as being problematic with respect to work and food shopping. the literature shows that hand hygiene education and vaccination development are required for pandemic influenza control. social distancing is effective in infection control as a form of isolation. at the commencement of the pandemic, health department officials advised people with ili to present to their local ed causing overwhelming presentations by those with ili and those fearful they may have had contact. , , in a pandemic, general practitioner and hospital waiting rooms are a potential site for cross infection to already unwell people if people present with a highly infectious illness. this happened during the sars outbreak in canada in . the literature indicates that these patients are best treated in other sites. overcrowded living conditions contribute to rapid influenza spread. this contributed to the disproportionately high impact of pandemic h n influenza in indigenous communities in the northern territory. school closures have been used as a means of social distancing. however a western australian survey of parents whose children were in schools closed during the h n influenza pandemic revealing that % of these students participated in out of home activities including sporting events, shopping, outdoor recreation and parties while their schools were closed. this paper questions the efficacy of school closure in preventing infection spread, highlighting that students were congregating elsewhere. an example of effective isolation practice was seen during the simultaneous outbreak of pandemic h n influenza and seasonal (h n ) influenza which was contained on two australian cruise ships. the conditions encouraging contagion on the ships included living and socialising in partially enclosed close proximity, and people from both hemispheres (i.e., opposite flu season) coming together. prior to the outbreak, the ship procedures already included point-of-care testing, antiviral medication and isolation for ili patients. however, not all ill passengers sought medical care, presumably because they had mild illness or were unwilling to be isolated while holidaying. after disembarkation, passengers discovered their need to be quarantined via media reports, word of mouth, from ship staff or public heath staff. almost all complied with quarantine requirements, and only one case of infection passed from a passenger to another person was found, with no further community spread. thus, an epidemic on board ships was prevented from contributing to the pandemic. many people continue to work when they are ill. in the tropics influenza is under-recognised and under-diagnosed, which can cause people to inadvertently infect families, colleagues and patients. studies have shown that many healthcare workers either go to work or intend to work when they have influenza. [ ] [ ] [ ] one hospital in the usa experienced high levels of infection in their eds at the peak of h n influenza pandemic, with no commensurate increase in sick leave. this finding was reflected in a recent australian study. thus, the literature indicates that healthcare workers need further education on this matter. australian healthcare guidelines recommend contact and droplet precautions for influenza control. contact precautions include surface cleaning, hand hygiene, the use of gloves and gowns, single-use equipment wherever possible, and masks and eye protection when splashes may occur. additionally, droplet precautions add patient isolation or cohorting and minimising patient transfers. particulate respirators, eye protection, and impervious gowns and gloves, are advised for all aerosol-generating procedures, which should be performed in a negative pressure room if available. , , , australian guidelines recommend surgical masks for those entering an infectious area, coming within m or m of an infectious patient. where tolerated, masking the patient is more effective than masking the health care workers. personal protective equipment is vital to healthcare workers who cannot be protected in any other way prior to effective vaccine development. in , slow distribution of personal protective equipment from the national stockpile to frontline workers was a problem, with general practitoner practices running out of stock and being unable to replace it early in the pandemic. while the cdc recommends the use of respiratory protection of at least the equivalent of n masks for health care workers managing patients with ili, canadian research has found n masks are no more protective in influenza than normal surgical masks. inconsistencies in recommendations between authorities must be resolved to improve staff compliance and confidence. thus the literature calls for better distribution of personal protective equipment during an influenza pandemic and identifies research is required into appropriate mask usage. public education is vital to stop influenza spread. materials used must target the audience and be culturally appropriate. in the hunter new england area, focus groups identified challenges and potential solutions for limiting pandemic influenza in indigenous communities. these included having a local resource person with an understanding of the disease, provision of clear, simple, culturally appropriate information, access to health services and knowledge of how obtain these without infecting others, sensitivity to the importance of family and cultural gatherings, and aboriginal people having a say in how support is provided. pregnant women were targeted and encouraged to take precautions against acquiring infection and accept vaccination. doha developed a website which gave detailed advice for individuals, households, healthcare providers, businesses and communities, and provided a telephone hotline. this allowed people to receive the best possible advice in a timely fashion. the media are vital to spreading public health messages, but can be sensationalist, ill-informed, and may desensitise the public to the issue through information overload or precipitate 'moral panic'. , a single, knowledgeable, authoritative voice has the best chance of conveying information effectively. while vaccination is vital to halt the spread of pandemics, time is needed for development and production. an american study found that most of the people they surveyed would not accept a new, not fully tested vaccine approved under emergency use authorization. healthcare worker immunisation rates in australia are reportedly between % and %. reasons include low perception of personal risk, poor knowledge of how immunisation works, doubts about vaccine efficacy and/or safety, self-perceived contraindications, and inconvenient access. in spite of the hong kong experience of sars, a study conducted prior to and repeated during the outbreak of pandemic h n influenza reported no significant increase in intention to receive immunisation, with participants citing fears of side effects and doubts of efficacy. this was echoed in a more recent australian study with widespread perception that the pandemic h n influenza vaccine was rushed into production and not comprehensively tested. , low acceptance was also reported in greece. in the usa there was low public willingness to accept vaccination under an emergency order. when released in australian, presentation in multi-dose vials posed a problem, with insurance companies initially refusing to cover administering general practitioners. the use of multi-dose vials for mass immunisation was part of the ahmppi, and known associated risks can be minimised by adherence to clear guidelines on their use. alternative vaccination sites, including retail outlets and workplaces, have been proposed to increase public uptake of influenza vaccination. british columbia has proposed regulatory changes to allow pharmacists to administer vaccines. treatment for pandemic influenza is a matter of conjecture until the actual virus is identified and the clinical profile emerges. most pandemic h n influenza cases required simple supportive treatment including rest, fluids, and antipyretics, however advanced oxygenation therapy including high-frequency oscillation ventilation, nitric oxide or extracorporeal membrane oxygenation was required for some with severe disease. stockpiled ventilators were too old or too simple to provide complex ventilation strategies. [ ] [ ] [ ] [ ] debate occurred about the efficacy of oseltamivir for the treatment and prevention of pandemic h n influenza . the cochrane review concluding it merely shortened the duration of symptoms by h if given within h of disease onset, and thus should only be given to those sufferers with known risk factors for severe disease - especially as side effects include gastrointestinal symptoms and headaches, with rare cases of delirium and psychosis (most frequently in children and adolescents), raised liver enzymes, and allergic reactions. guidelines recommend oseltamivir administration within h of disease onset. adherence to this would have seen many treated for a disease they did not have in the h n influenza pandemic, as overwhelmed pathology services saw extended time lags between specimens being sent for testing and the arrival of results. generally speaking, humanity was better prepared for the h n influenza pandemic than for any other pandemic in history. while the disease itself was less virulent than expected, it confirmed the unpredictability of pandemic influenza, and its ability to cause significant impacts on health systems and the community. the h n influenza pandemic highlighted unresolved challenges identified in both exercise cumpston and exercise sustain , which we as a profession and society must address. public health challenges include developing means of increasing acceptance of influenza vaccination by both the general public and healthcare workers, provision of targeted education for the indigenous population and other at-risk groups, improving public knowledge of social distancing and personal hygiene measures in the prevention of transmission, and improving dissemination of information during a pandemic, especially via the media. we can use the evidence to refine pandemic plans and promote community well-being during an influenza pandemic. jennifer r. patrick and gerard j. fitzgerald have no competing interests or conflict of interests to declare. ramon z. shaban is editor-in-chief of the australasian emergency nursing journal but had no role in the editorial review of this manuscript whatsoever, and has no other competing interests or conflict of interests to declare. world health organization. who checklist for influenza pandemic preparedness planning department of health and ageing. pandemic influenza -types of influenza microbiology and infection control for health professionals s principles and practice of infectious diseases a/h n influenza virus the basics communicable disease control handbook asid (hic-sig) position statement: infection control guidelines for patients with influenza-like illnesses, including pandemic (h n ) influenza , in australian health care facilities. emja influenza in the acute hospital setting clinical management of human infection with pandemic (h n ) : revised guidance department of health and ageing. pandemic influenza world health organisation swine flu --lessons learnt in 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protection of healthcare personnel infection prevention and control in health care for confirmed or suspected cases of pandemic (h n ) and influenza-like illnesses preventing the spread of influenza a h n to health-care workers outbreak of swineorigin influenza a (h n ) virus infection -mexico surgical mask vs n respirator for preventing influenza among health care workers: a randomized trial hospitals and the novel h n outbreak: the mouse that roared reducing the risk of pandemic influenza in aboriginal communities centers for disease control & prevention. pregnant women need a flu shot public willingness to take a vaccine or drug under emergency use authorization during the h n pandemic influenza vaccination among healthcare workers influenza vaccination of health care workers in hospitals--a review of studies on attitudes and predictors willingness of hong kong healthcare workers to accept pre-pandemic influenza vaccination at different who alert levels: two questionnaire surveys toll of second swine flu wave could be high low acceptance of vaccination against the pandemic influenza a(h n ) among healthcare workers in greece insurance row threatens swine flu vaccinations h n and the use of multi-dose vials in mass vaccination alternative vaccination locations: who uses them and can they increase flu vaccination rates? ministry of health services british columbia. proposed changes allow pharmacists to give injections the experiences of health care workers employed in an australian intensive care unit during the h n influenza pandemic of : a phenomenological study critical care doctors want escalated pandemic planning novel h n influenza: the impact on respiratory disease and the larger healthcare system preparing for pandemic (h n ) neuraminidase inhibitors-the story behind the cochrane review what can we learn from observational studies of oseltamivir to treat influenza in healthy adults? neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis module name=product% info&searchkeyword=oseltamivir+phosphate &previouspage=∼/search/quicksearch. aspx&searchtype=&id= #an-adversereactions key: cord- -yw rzrb authors: prateepko, tapanan; chongsuvivatwong, virasakdi title: patterns of perception toward influenza pandemic among the front-line responsible health personnel in southern thailand: a q methodology approach date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: yw rzrb background: thailand has joined the world health organization effort to prepare against a threat of an influenza pandemic. regular monitoring on preparedness of health facilities and assessment on perception of the front-line responsible health personnel has never been done. this study aimed to document the patterns of perception of health personnel toward the threat of an influenza pandemic. methods: q methodology was applied to a set of health personnel in charge of influenza pandemic preparedness in the three southernmost provinces of thailand. subjects were asked to rank statements about various issues of influenza pandemic according to a pre-designed score sheet having a quasi-normal distribution on a continuous -point bipolar scale ranging from - for strongly disagree to + for strongly agree. the q factor analysis method was employed to identify patterns based on the similarity and dissimilarity among health personnel. results: there were three main patterns of perception toward influenza pandemic with moderate correlation coefficients between patterns ranging from . to . . pattern i, health personnel, which we labeled pessimistic, perceived themselves as having a low self-efficacy. pattern ii, which we labeled optimistic, perceived the threat to be low severity and low vulnerability. pattern iii, which we labeled mixed, perceived low self-efficacy but low vulnerability. across the three patterns, almost all the subjects had a high expectancy that execution of recommended measures can mitigate impacts of the threat of an influenza pandemic, particularly on multi-measures with high factor scores of in all patterns. the most conflicting area was vulnerability on the possible impacts of an influenza pandemic, having factor scores of high ( ), low (- ), and neutral ( ) for patterns i, ii, and iii, respectively. conclusion: strong consistent perceptions of response efficacy against an influenza pandemic may suggest a low priority to convince health personnel on the efficacy of the recommended measures. lack of self-efficacy in certain sub-groups indicates the need for program managers to improve self-confidence of health personnel to participate in an emergency response. an influenza pandemic is a significant natural health threat that has periodically occurred over the past years [ ] . its severe impacts to global human health, healthcare service, society, and economy were evidently documented during the previous pandemics [ , ] . for a coming one, influenza experts have agreed that this threat is inevitable and possibly imminent [ ] . if the next pandemic occurs, it is expected that % of the global population will become ill, nearly million will be hospitalized and a quarter of these would die within a few months of its attack [ ] . to mitigate the impacts of this threat, the world health organization (who) has recommended that all countries should consider this threat as very important and urged them to make preparations a high national priority. thailand occasionally has had serious outbreaks of avian influenza a (h n ) since early , in both poultry and humans. in response to these outbreaks and a possible future influenza pandemic, the national committee on avian influenza control and influenza pandemic preparedness has issued a national strategic plan for influenza pandemic preparedness. beyond preparedness, the perception of each individual is also a fundamental factor that contributes to the spread, prevention, and control of infectious diseases. for example, during the severe acute respiratory syndrome (sars) epidemics, the perceptions toward this disease had an effect on the preventive health behaviors (e.g., hand hygiene, mask wearing) and that consequently contributed to containing the outbreaks [ ] [ ] [ ] . for a current threat of an influenza pandemic, sporadic perception surveys among health workers have been done in developed countries [ ] [ ] [ ] [ ] . yet this issue has not been explored in developing countries, particularly in the southeast asian region where it is more likely to be a source of the next pandemic [ ] . southern thailand experienced a probable sars case in , but there has been no reported case of avian influenza a (h n ) in both poultry and human. however, the region faces a serious problem of ethnic violence. this unrest has led to the loss of over , lives and more than , injuries in the past years. it is possible that the local health systems may have deteriorated due to the unrest leading to loosening of preparedness against the threat of an influenza pandemic. we have therefore conducted a study to investigate the preparedness. the current report is confined to perceptions related to the threat of an influenza pandemic with the objective to document the patterns of perception of health personnel toward this threat in southern thailand. as health personnel are key persons for influenza pandemic preparedness and con-trol, it is hoped that understanding their patterns of perception will allow control programs to properly improve the training. it may also be useful for other developing countries where an influenza pandemic is a serious threat, but the personnel are not fully prepared. q methodology, which basically originated from the theory of factor analysis [ ] was applied. while conventional factor analysis is used in scale development and tries to group items or variables, q method tries to group subjects. therefore, people of the same group or having the same factor will have a similar pattern of chosen statements. the implication would be that it would be easy to put people of the same factor into the same intervention program. this method was taken into our study because this is a scientific and systematic study of human subjectivity, involving perceptions, attitudes, and opinions [ , ] . furthermore, it is also unique since it mixes the strong points of both qualitative and quantitative research techniques, compared to traditional surveys [ , ] . in doing q, the flow of communication surrounding the study topic (concourse) is firstly formed to get a wide range of ideas toward that topic. this is generally collected from various sources (e.g., scientific papers, books, news, interviews, focus group discussions, etc.). it is commonly presented in the form of statements. afterward, a q sample (a representative set of statements) is selected from the concourse and developed to be more meaningful, which represents various issues of the study topic and eventually is compiled into the instrument. the study subjects are then asked to rank the representative statements and place them into a score sheet, which is designed in a continuous scale ranging from strongly disagree to strongly agree, following a standardized instruction based on the judgment of each subject. this is known as the q sorting procedure. the sheets that are completely ranked by each subject (qsort) are finally correlated and analyzed by q (subjectwise) factor analysis, and the factors are then interpreted. in our study, statements on various issues of an influenza pandemic were initially gathered from scientific articles, newsletters, and books to form a concourse. the protection motivation theory (pmt) was used as a basis for grouping and developing the statements into four domains: perceived severity, perceived vulnerability, perceived response efficacy, and perceived self-efficacy, by refining, clarifying, and combining the raw statements to be more meaningful and more understandable. to catch various aspects of an influenza pandemic and keeping the total number of the statements suitably manageable by our subjects, we included eight refined statements in each of such four domains with one additional item added to make the total number of the statements equal (qsample). these statements were then placed into the score sheet (figure ), and forced to follow a quasi-normal distribution, that is, - - - - - - - - . the reliability of this instrument was tested with cronbach's alpha. each statement was randomly assigned a number from to for the subjects to arrange and place into the score sheet. to get more understandability, the statements were pilottested with health personnel and were then revised as appropriate before the study. the study was conducted in the three southernmost provinces of thailand: yala, pattani, and narathiwat, during april to october . apart from the problems of ethnic violence, the area is in a remote part of the country where the logistic problems will be easily visible. the area is also close to malaysia, so cross-border diseases have a high chance of spread due to the movement of populations. the research protocol was approved by the ethics committee of the faculty of medicine, prince of songkla university, prior to conducting the study. a list of all health facilities in the study area was obtained from the local health offices. health personnel designated by each facility to be responsible for influenza pandemic preparedness were identified. these included a numbers of doctors, nurses, pharmacists, laboratory personnel, public health specialists, public health administrators, and junior health workers. all were invited to participate in the study. the selected personnel were sent a set of documents, which included a cover letter, an overview describing the study importance and objective, a set of statements (q sample), a standardized step-by-step set of instructions for responding to the study, and a score sheet. following the initial mailing, two phases of follow up were performed: a sequence of telephone calls at one month, with nonresponders contacted by the first author after three months. each consenting subject was asked to rank the statements about different issues concerned with an influenza pandemic into the levels of agreement and disagreement based on their own judgments. each participant was requested to place two statements in the columns of strongly disagree (- ) and strongly agree (+ ), three in disagree (- ) and agree (+ ), four in - and + , five in - and + , and five statements in the neutral response column ( ). however, if they thought that our distribution did not represent their real perceptions, they were encouraged to sort such statements accordingly. each q-sort was considered as complete if all statements were placed into the score sheet without repetition of the statements. the data from each completed score sheet were entered and analyzed in pqmethod . (free software). betweensubjects correlation matrix was computed and a q (subject-wise) factor analysis by principle components analysis (pca) method was performed using a varimax rotation technique. factors that could explain more than % of the variance were adopted and retained into the final solution. a participant who had absolute factor loadings of larger than ± . , which suggests high significance (p < . ) with the group, was included into that particular factor. in each factor, the ascending sorted normalized scores (z-scores) of assigned number of each statement were returned into the score sheet from right to left order (figures , , and ) . each final score sheet thus displays the pattern of the defined factor. comparisons among patterns were based on the factor scores and the mean values of the domain of the statements. for visualization of the patterns, the domains of each statement were linked to different colors or grey shadings in the final q-sort models that are shown in figures , , and . since the cells in the extreme score regions reflect strong perceptions in the domains, they are the primary target for comparing similarity and dissimilarity of each group of health participant score sheet figure participant score sheet. strongly agree [ ] [ ] [ ] [ ] [ ] pattern i. pessimistic with perceived low self-efficacy figure pattern i. pessimistic with perceived low self-efficacy. personnel's perceptions on the threat of an influenza pandemic. after consultation with an expert in instrument development, statements listed in table of a total health personnel, ( %) persons completed the score sheet. there were no statistically significant differences between responders and non-responders in terms of gender, age, religion, educational level, total period of working, job classification, experience of getting training on influenza pandemic preparedness and perceived levels of knowledge about an influenza pandemic, public health measures against an influenza pandemic and impacts of an influenza pandemic. however, the nonresponders had a lower educational level than those of the responders ( % vs. %, respectively). the basic characteristics of the respondents are presented in table . q factor analysis gave three factors that met our criteria with the percentages of explained variance being . %, . %, and . %, respectively. after varimax rotation, subjects were classified into factor i (in other words, the first pattern composites of health personnel), into factor ii, and into factor iii. the other subjects were not classified into any factor because all their loading values were less than . or had high loading on more than one factor. the composite reliability of each factor was . , with the corresponding standard errors of factor scores being . , . , and . . the correlation coefficients between the three factors were . (factor i vs. ii), . (factor i vs. iii), and . (factor ii vs. iii), indicating a moderate similarity among the patterns. the three patterns had scores for each specific statement distributed into the q-sort model or composite factor array and are displayed in figures , , and . the same information is displayed in table . factor scores of statement were , - , and - as shown in the first row of table . in the q-sort model, statement is in column + of figure , and column - of figure , and column - of figure . from table , statement number has a common factor score of for all three patterns. this indicates that all three patterns of health personnel strongly perceived that multimeasures must be performed during an influenza pandemic. statement number was also in columns + of figures and , and + of figure , which is related to response efficacy on multilevels of responsibility for preparedness against the threat. in contrast, statement was the most dissenting issue with factor scores of , - , and . health personnel classified as pattern i quite strongly perceived that thailand will have possibly high impacts from an influenza pandemic if and when one occurs, but those classified in pattern ii strongly disagreed, and those in the remaining group were neutral. the right extremes of all three q-sort models are consistently filled with three black cells (statements , , and ) out of cells of that region. this indicates that all three pattern ii. optimistic with perceived low severity and low vul-nerability figure pattern ii. optimistic with perceived low severity and low vulnerability. pattern iii. mixed with perceived low self-efficacy but low vulnerability figure pattern iii. mixed with perceived low self-efficacy but low vulnerability. means of factor scores for each component of the pmt are displayed in table . all groups had positive perceived response efficacy of the measures. patterns i and iii, however, perceived low self-efficacy, in contrast to high perceived self-efficacy of pattern ii. optimistic personality of pattern ii was also expressed as perception of low severity and low vulnerability where the pattern i has isolated neutral perception of severity with a moderate level of perceived vulnerability. finally, more mixed appraisal is found in pattern iii, the group who perceived a low level of vulnerability but a very high level of severity. we identified three main patterns of health personnel in southern thailand based on the perception toward a threat of an influenza pandemic. pattern i was pessimistic (strongly perceived response efficacy, but perceived low self-efficacy). pattern ii was optimistic (strongly perceived response efficacy, but perceived low severity and low vulnerability). pattern iii was mixed (strongly perceived response efficacy, but perceived low vulnerability and low self-efficacy). a high perception on response efficacy was predominantly found in all health personnel groups. perceptions on vulnerability were more varied. the majority of our health personnel perceived low selfefficacy toward an influenza pandemic. self-efficacy is one important component of coping appraisal of the pmt [ ] . it has powerful influence on human's feeling, thinking, motivation, and behavior [ ] [ ] [ ] . previous metaanalyses provided evidence for self-efficacy having the largest effect size and was the strongest predictions of protection motivation [ , ] . people with low self-efficacy usually believe that tasks are harder than they can handle. this can lead to limit task planning, increase stress, reduce the low level of attempt, and having a tendency to avoid duties and activities [ ] [ ] [ ] . balicer et al. reported that nearly a half of local health workers may be unwilling to report to duty during a pandemic event [ ] . however, that study did not identify different patterns of health workers as our study has done. another conventional survey conducted among a general population (rather than health workers) in developed countries of europe and asia on avian influenza risk perception showed a similar result. the level of self-efficacy among the respondents was also low and the authors concluded that a low level of self efficacy may obstruct any interventions [ ] . the most dissenting issue among our health personnel toward this threat was on vulnerability of possible impacts in the country (statement number ). naturally, the occurrence and severity of an influenza pandemic cannot be predicted [ ] . fifteen per cent of our health per- showed that more than half did not consider that the risk of an imminent influenza pandemic was more than a possibility [ ] . both perceived severity and perceived vulnerability are components of threat appraisal of the pmt [ ] . perception of low level of severity and vulnerability or low levels of appraised threat of an influenza pandemic may inhibit motivation of health personnel to engage in protective behavior [ , ] . however, the effect sizes of such two components in previous meta-analyses were small to medium and barely predicted of protection motivation and behavior compared to the components of coping appraisal (response efficacy and self-efficacy) [ , ] . perception of response efficacy was stronger than other domains. this may be influenced by past experiences of the country, which after employing on multi-sectors and multi-measures could successfully suppress avian influenza a(h n ) [ ] . this study used a wide range of front-line health personnel responsible for influenza pandemic preparedness. thus, it may reflect the problems specific to this area with acceptable accuracy. the study was confined to the three southernmost provinces of thailand where avian influenza a (h n ) has never occurred. our study subjects might be different from those in other regions of the country where the infected cases of that avian influenza in both humans and poultry have been reported, and intensive avian influenza controls have been fully activated. the study subjects were also predominated by personnel from health centers and community hospitals in rural areas. the threat of a pandemic may be less compared to in urban areas. the study was based on q methodology which had never been employed among local health workers; thus, the data have to be interpreted with caution. approximately % of the respondents were not able to be classified into any of the three groups determined by our factor analysis. the patterns are therefore far from ideal. the statements about influenza pandemic that were used in our study should be improved to be more specific for health workers in future work. despite the above limitations, this study highlights important findings. strong consistent perceptions of implementing recommended measures against an influenza pandemic can remove or mitigate impacts of this threat, and may suggest a low priority to convince health personnel on the efficacy of the measures. perception of low self-efficacy in certain subgroups who gave low scores on the statements related to self-efficacy on an influenza pandemic indicates the need to improve self-confidence of health personnel to participate in an emergency response by the control program. potter cw: a history of influenza seasonal and pandemic influenza preparedness: a global threat influenza pandemics of the th century are we ready for pandemic influenza? will vaccines be available for the next influenza pandemic? sars transmission, risk factors, and prevention in hong kong sars-related perceptions in hong kong. emerg infect dis monitoring community responses to the sars epidemic in hong kong: from day to day local public health workers' perceptions toward responding to an influenza pandemic physicians' perception of pandemic influenza perception in relation to a potential influenza pandemic among healthcare workers in japan: implications for preparedness koh d: concerns, perceived impact and preparedness in an avian influenza pandemic -a comparative study between healthcare workers in primary and tertiary care capacity of thailand to contain an emerging influenza pandemic doing q methodology: theory, method and interpretation a primer on q methodology q methodology-a journey into the subjectivity of human mind q methodology: definition and application in health care informatics cognitive and physiological processes in fear appeals and attitude change: a revised theory of protection motivation self-efficacy: toward a unifying theory of behavioral change human agency in social cognitive theory self-efficacy: the exercise of control a meta-analysis of research on protection motivation theory prediction and intervention in health-related behavior: a meta-analytic review of protection motivation theory avian influenza risk perception blaser mj: pandemics and preparations protection motivation theory effects of components of protection motivation theory on adaptive and maladaptive coping with a health threat grotto i: a systematic analytic approach to pandemic influenza preparedness planning this study was part of the first author's thesis to fulfill the requirement for phd in epidemiology at prince of songkla university (psu). we sincerely acknowledge all health personnel who participated in the study. appreciative thanks to the graduate school, psu, and the disease control department, ministry of public health, thailand for supporting the study. we also wish to thank dr. alan geater, dr. vorasit sornsrivichai, mr. edward mcneil, the epidemiology unit, faculty of medicine, psu, and mr. darrell beng, adelaide, south australia. the authors declare that they have no competing interests. tp designed this study, was the principal investigator of the project, performed data analysis, and drafted the manuscript. vc provided supervision, suggestion, and development on manuscript writing. all authors have contributed to revision of the draft version and have read and accepted the final version of this manuscript. the pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/ - / / /pre pub key: cord- -qvmhuid authors: giorgi, gabriele; leon-perez, jose m.; pignata, silvia; topa, gabriela; mucci, nicola title: addressing risks: mental health, work-related stress, and occupational disease management to enhance well-being date: - - journal: biomed res int doi: . / / sha: doc_id: cord_uid: qvmhuid nan the importance of a contextualized health approach with a focus on organizational environments is becoming more strategic than ever due to covid- and the ensuing difficult situation that employees are experiencing worldwide. the prevention of workers' mental health problems is complex and multidimensional, and it is not always possible to protect the person by analyzing personality, psychopathology, and psychiatric syndromes. accordingly, a peer review process involving international experts, with papers accepted in this special issue, considered the important concept of work contextualized health. from this perspective, this special issue had the power to establish a dialogue between the multiple disciplines completing the majority of research on mental health constructs within clinical, neuroscientific, and psychiatric contexts, which usually led to a person-centered analysis or research conducted in artificial laboratory settings. as stated by giorgi et al. [ ] , trauma and diseases related to stress and mental health that originate in the workplace may have a different pattern of development or require an organization-centered treatment approach, including field and intervention studies. in addition, this special issue followed the united nations agenda for developing sustainable goals by [ ] and tried to contribute to two of these goals: ( ) promoting well-being at all ages, including mental health, and ( ) promoting safe and secure working environments to create a decent work for all. in doing so, this special issue assumed that addressing such goals required an interdisciplinary approach involving scientific fields ranging from occupational medicine to organizational psychology. regarding the promotion of well-being at all ages, g. giorgi et al. concluded in their narrative review that stress management strategies at work need to include "aging" as a crucial variable to tailor interventions and prevent workers' cognitive impairment processes. also, m. ziarko et al. pointed out the necessity to consider the health and wellbeing of workers with chronic disease. in particular, their paper analyzed the mental health consequences of the type of treatment received by participants affected by rheumatoid arthritis and confirmed the assumption that pain intensity, coping strategies, and ego resiliency depend on the severity of their levels of anxiety and depression. similarly, two papers emphasized the need to consider all agents involved in an organization, including students, as targets of safety and well-being measures. k. gerreth et al. analyzed the anxiety of dental students during their first clinical class involving performing a prophylactic procedure in a pediatric patient. their results indicated that more than % of students reported high levels of anxiety. these findings emphasize the need for students to be trained to deal with stress as a part of their academic curriculum. in addition, k. frömel et al. explored whether students reporting academic stressors differ in physical activity after school compared to those students that did not report being exposed to academic stressors. although their hypotheses were not supported, it seems that gender should be taken into account when promoting physical activity to reduce stress: girls in the academic stressor group walked more (steps/hour measured with accelerometers) than girls in the nonacademic stressor group. also, their study is a good example on how new devices such as accelerometers can be used to collect information in occupational health and safety research. with regard to promoting safe and secure working environments to create a decent work for all, some papers published in this special issue introduce advances in measuring psychosocial risk factors, mental health, and work-related issues. for example, n. tao et al. conducted a study in which they analyzed the relationship between occupational stress and secretory immunoglobulin a (siga) in a sample of military recruits during their basic military training period. as expected, siga measured in saliva and quantified by enzyme-linked immunosorbent assay presented higher levels in the high occupational stress group than that in the low stress group. furthermore, the salivary siga level was also associated with perceived personal strain. another work using innovative approaches to assess psychosocial risks and their consequences is the paper by j. r. lópez-garcía et al. they proposed using bayesian networks to determine the probability of an occupational accident in a certain productive sector depending on the relationship between ergonomic and psychosocial factors. they used data from a national survey of working conditions in spain (n = , ) to illustrate their approach. their results suggest that ergonomic risks associated with physical strains and a lack of job satisfaction are associated with a higher probability of being involved in an occupational accident. in contrast to these new approaches, traditional approaches to conduct psychosocial risk assessments are based on self-rated scales. in that sense, it is important to validate well-known scales to facilitate cross-cultural comparisons. this is the case of the study conducted by a. s. n. isha et al. who validated the copenhagen psychosocial work environment questionnaire (copsoq) in malaysia. they also proposed the inclusion of physiological measures (blood pressure and body mass index) to monitor workers' health. similarly, v. katsari et al. validated the jefferson scale of patient perception of physician empathy in greece, which may be useful for monitoring both physicians' health and the quality of service that they provide. a noteworthy aspect of this study was the comparison between self-rated empathy and their patients' ratings. a similar approach was followed by i. schneider et al. in their research on the degree of agreement between self-rated and observer-rated occupational psychosocial risks. they compared the ratings of workers and occupational safety and health committees to occupa-tional psychosocial risks measured with the same instrument (n = ). their findings showed that observer ratings and self-ratings provided comparable results. therefore, they concluded that (a) the observer rating approach is especially suitable for small-to-medium enterprises that do not have access to a large anonymous survey assessment and (b) aggregation of item means at the group level is justified because their results showed a reasonable agreement and excellent reliability in workers' self-ratings, and therefore, the self-rating approach can be very useful for large enterprises. another way to improve existing scales to measure psychosocial risks at work is to add relevant dimensions that are associated with employees' health and well-being. in that sense, the work by k. kowalczuk et al. attempted to identify the most arduous and frequently occurring burdens in nursing workplaces. they found that ward type predicted the level of work arduousness beyond other factors such as age or gender, suggesting that trauma and diseases related to stress and mental health that originate in the workplace may have a different pattern of development or require an organizationcentered treatment approach that complements the personcentered approach derived from research conducted in clinical and psychiatric contexts. in a similar vein, m. martini et al. highlighted the importance of including both demands and support derived from interactions with students when conducting psychosocial risk assessments in higher education. with a sample of professors from a large public university, their results revealed that relationships with students can play a crucial role in how academics experience emotional exhaustion and engagement at work. also, findings from the study conducted by m. del mar molero jurado et al. in the education sector reaffirm that burnout is a pivotal psychosocial risk that requires prevention within the sector. they proposed that measures to prevent burnout need to consider the educational context when implementing preventative actions both at the individual (i.e., increasing self-efficacy) and organizational level (i.e., improving the education system). moreover, organizational level measures should include the promotion of healthy behaviors as emphasized by research on public health initiatives to prevent noncommunicable diseases [ ] . this is clearly exemplified in the study by a. habib et al. who analyzed the risk factors of noncommunicable diseases in a sample from saudi arabia (n = , ) . their findings revealed the need to promote healthy behaviors as a suitable public health strategy to reduce noncommunicable diseases such as cardiovascular disease or diabetes. in addition to these potential measures to promote health and well-being, the literature has indicated that active coping and recovery from work are crucial to avoid stress-related problems [ , ] . in that sense, the paper by y. hsu et al. reported that working more hours was associated with higher levels of occupational stress, which was related to lower levels of work-family balance and job satisfaction. they found that perceived control over time plays a protective role because it was associated with increased recovery-related self-efficacy. in addition, a focus on coping strategies by x. wang et al. revealed that biomed research international depressive symptoms in military institutions is a matter that needs to be considered, as they found that the relationship between coping (i.e., hardiness) and depressive symptoms is mediated by motivational dispositions. addressing psychosocial risks and introducing preventive measures at work are equally important as identifying who is exposed to the risks and what are the potential negative consequences on employees' health and well-being. first, a. przystanska et al. explored the psychosocial predictors of bruxism. they concluded that perceived stress is a crucial somatic factor in the occurrence and maintenance of awake bruxism. second, k. golonka et al. went beyond the usual negative effects of burnout and explored potential brain activity differences between burned-out and nonburned workers (control group). their results suggest that participants in the burnout group showed cortical hyperactivity, which results in reduced alpha power compared to participants in the control group. finally, t. mitake et al. analyzed the stigma related to mental illness in the workplace, such as the psychological consequences derived from burnout. this relationship is important to examine because being stigmatized at work due to mental illness can result in experiencing discriminative behaviors. following the abovementioned findings, another factor that deserves special attention to create a decent work for all is the promotion of working environments free from discrimination and violence, including sexual and psychological violence (i.e., sexual harassment or workplace bullying). the paper by s. a. jahnke et al. addressed the prevalence of chronic work discrimination and the harassment of women firefighters (n = , ) and its psychosocial consequences. their results revealed that a considerable percentage of women firefighters reported that they had experienced verbal harassment ( . %) and unwanted sexual advances ( . %) in their fire service work. furthermore, this discrimination and harassment at work were related to increased alcohol consumption and mental health problems, including depressive symptoms, anxiety, and posttraumatic stress symptoms. similarly, s. berlanda et al. analyzed the experiences of violence (emotional, physical, and sexual) perpetrated by patients and visitors against healthcare professionals working in emergency units. they found that greater age and higher scores in secure attachment are associated with reduced experience of emotional violence from patients and visitors, and the relationship between secure attachment and the amount of patient-and-visitor-perpetrated emotional violence experienced is mediated by levels of job satisfaction. finally, with regard to the ongoing situation and the economic crisis caused by the covid- pandemic, employee welfare and social support may not be the current priorities for companies as they attempt to maintain their survival by staff layoffs and budget reductions [ , ] . moreover, studies have shown that turbulent economic periods, in which job uncertainty is the norm, create a fertile soil for the increase of violence at work and stress-related mental health problems [ , ] . in this regard, s. de sio et al. studied the role of job insecurity in the perception of psychosocial risks at work in a sample of administrative technical workers and found that workers with temporary contracts perceived higher exposure to psychosocial risks at work than their colleagues with permanent contracts. the contributions to this special issue highlight the essential need to consider organizational practices and culture in the management of mental health problems linked to the workplace as organizational causes are often more harmful than individual antecedents. raising awareness of the organization's intervention politics, of organizationworker health relationships at work, and of an organizational science of mental health appears necessary. overall, the manuscripts included in this special issue reported the perspectives of authors, reflecting a valuable cross-cultural point of view on health prevention and promotion. in conclusion, we would like to share a reflection on what we have seen during the covid- pandemic as workers' mental health still represents a point of fragility of the systems-countries, where an overly medicalized and pathologizing model of mental health risks hiding not only organizational causes and responsibilities creating an image of stigmatized workers but also hiding potential and successful organizational interventions in prevention, safety, and health areas. there is therefore a disharmonious relationship between business and health while, as strongly supported by the business@health laboratory of the european university of roma, there is no business without employee health, and in the same way, employee health becomes business. addressing risks: mental health, work-related stress, and occupational disease management to enhance wellbeing sustainable development goals knowledge platform social determinants and noncommunicable diseases: time for integrated action recovery from job stress: the stressor-detachment model as an integrative framework after work is done: psychological perspectives on recovery from work fear of nonemployability and of economic crisis increase workplace harassment through lower organizational welfare orientation psychosocial factors and economic recession: the stormont study going beyond workplace stressors: economic crisis and perceived employability in relation to psychological distress and job dissatisfaction the editors declare that they have no conflicts of interest regarding the publication of this special issue. silvia pignata gabriela topa nicola mucci key: cord- -jmd wosy authors: rutten, martine; reed, geoffrey title: a comparative analysis of some policy options to reduce rationing in the uk's nhs: lessons from a general equilibrium model incorporating positive health effects date: - - journal: j health econ doi: . /j.jhealeco. . . sha: doc_id: cord_uid: jmd wosy this paper seeks to determine the macro-economic impacts of changes in health care provision. the resource allocation issues have been explored in theory, by applying the rybczynski theorem, and empirically, using a computable general equilibrium (cge) model for the uk with a detailed health component. from the theory, changes in non-health outputs are shown to depend on factor-bias and scale effects, the net effects generally being indeterminate. from the applied model, a rise in the national health service (nhs) budget is shown to yield overall welfare gains, which fall by two-thirds assuming health care-specific factors. a nominally equivalent migration policy yields even higher welfare gains. the interactions between health care, health and the remainder of the economy are complex. on one hand, changes in income affect the consumption and/or provision of health care and other goods, and thus the health of populations in terms of illness and mortality. on the other hand, changes in health impact upon the well-being of populations, hence labour market participation, productivity and income. developed countries, with high living standards and levels of health, are argued to be in a state where the marginal contribution of health care to health is minimal and other factors, such as diet, lifestyle, environment and education, are more important in explaining variations in health (folland et al., , chapter ) . however, many former sceptics of the contribution of health care now accept that, even after allowing for diet and lifestyle, health care does make a difference for specific conditions, such as cardiovascular disease (wallace, ) . moreover, medical care also enhances the quality of life through pain relief and increased mobility. nevertheless, it has been argued that the majority of developed country health care systems fail to deliver specific medical services to a "satisfactory" standard, commonly attributing this to limited financial means and inefficient use of resources. in the uk, such pressures result in poor health outcomes for some diseases (such as cancer), poor service quality, including long waiting lists and waiting times for certain treatments, and inequities in access and health outcomes. these impose significant costs on society above those of health provision itself. health care costs themselves are bound to rise given an ageing population and advances in medical technology. while the interdependencies between health care, health and the rest of the economy are now widely acknowledged, most of the economic models used to assess these fail to incorporate the main channels through which interactions take place. most empirical studies employ econometric analysis and usually ignore the general equilibrium effects of changes in health and health care across sectors, factors, and households, and their implications for the government budget. econometric models typically focus on multiple linkages between health, health expenditures and economic growth at the aggregate (macro) level (e.g., baldacci et al., ; bhargava et al., ; bloom and canning, ; bloom et al., ; crémieux et al., ; ettner, ; hamoudi and sachs, ; hitiris and posnett, ; jamison et al., ; knowles and owen, ; mayer, a,b; pritchett and summers, ; strauss and thomas, ; stronks et al., ; thomas and frankenberg, ) . the few computable general equilibrium (cge) models that exist are diverse in their application area. those set in a developing country context may be categorised into basic needs models (kouwenaar, ; van der hoeven, , vianen and waardenburg, ) , externality models (savard and adjovi, ) , hiv/aids models (arndt, ; arndt and lewis, , ; arndt and wobst, ; dixon et al., ; kambou et al., ) and millennium development goal (mdg) models (e.g., lofgren and diaz-bonilla, ; sundberg and lofgren, ) . there are some "global" models, such as lee and mckibbin's ( ) model of the economic effects of severe acute respiratory syndrome (sars), and most recently smith et al.'s ( ) uk model of the macro-economic impact of antimicrobial resistance. while each of these strands of cge literature has its own merits, most do not assess the endogenous impact of changes in health care provision on population health, and on the labour force in particular and its impact on production, income and welfare. empirical studies typically fail to account for the main feature of all nations' health care systems, namely that they treat and (perhaps partially) cure people, i.e., improve their health, which not only makes them "feel better" but also enlarges the effective size of the population through increased working time for some and reduced death rates for all. at the same time, health care systems use factors of production, which reduces their effective supply in the rest of the economy. it is in addressing this caveat that this paper seeks to make a contribution. the analysis is novel in two main respects. the first contribution is in terms of international trade theory, using the rybczynski theorem to cast light on some of the resource allocation issues related to the provision of health care. while there is a strong literature on endogenous labour supply models (e.g., martin, ; martin and neary, ) , the analysis has largely focused on direct labour supply responses to higher wages. here, changes in effective labour supplies come from changes in the size of the health sector. the second contribution is empirical, the development of a static cge model for the uk with a detailed health component. the cge model is calibrated to a purpose-built social accounting matrix (sam) for the uk for the year with considerable refinement in terms of sectors (distinguishing health care and its main input suppliers), factors (capital, skilled and unskilled labour) and household types (based on the age and labour market participation of household members). it is the first of its kind in that it has been designed to analyse the macro-economic impacts of changes in health care provision, while recognising the simultaneous effects of changes in health on effective labour supplies and the resource claims made by the health sector. the effects on welfare of higher health provision come through two main channels: (a) the direct gain from increasing the "well-being" of the population, and (b) the indirect effects of an increase in the size of the effective (i.e., "able to work") endowments of skilled and unskilled labour for use in non-health activities. taking as a case study the uk, an archetype of a developed country health care system in which government provision and funding dominates, allows the modelling and analysis of current "rationed" health care policies. specifically, we contrast three strategies for increasing health care provision through a higher national health service (nhs) budget on the assumption that domestic factor endowments are given. first, under the assumption that all factors are fully mobile within the economy and that there is no immigration of foreign skilled workers. second, by amending this by assuming that some factors are health care-specific factors. third, that there is immigration of foreign skilled workers at the current wage. the remainder of the paper is organised as follows. section presents an application of the rybczynski theorem where changes in effective labour endowments are modelled via changes in health provision. section explains the uk cge model and sam. section presents the results of the counterfactual simulations of policies aimed at alleviating rationing. the final section concludes and suggests directions for future research. an exception is the dixon et al. ( ) model of the impact of the hiv/aids pandemic and alternative health interventions on the botswana economy. however, this model focuses on one particular disease in a developing country setting. see rutten (forthcoming) for an analysis from the perspective of migration of skilled medical personnel into the uk, using a different version of the cge model and including a formal derivation of the theory. consider a small open "heckscher-ohlin" economy, endowed with two types of labour, skilled (s) and unskilled (u), both subject to illness at given rates. there are four sectors ("uses" for factors): goods and are conventional tradables, h is the non-tradable health sector treating the ill (modelled as 'adding value' to the ill) and w is an artificial "waiting list sector". the waiting list records those who are ill and not yet (successfully) treated by the health sector and so are unable to work. we assume that health care is provided by the government and that its expenditure is determined politically (and so is exogenous to this model). the exogenous product prices determine the factor prices and hence skilled-unskilled labour ratios in the three production sectors. these remain constant throughout the analysis. within the period concerned, some skilled and unskilled workers become ill and so unable to work. however, the health service successfully treats all but s w and u w respectively of these (the loss of working time for those successfully treated is taken, for simplicity, as negligible). accounting for factor use (paralleling the full employment conditions for standard trade models) gives: ( ) where s i and u i , i = , , h, are the numbers working, and s w and u w are the numbers of potential workers that remain unable to work. we are interested in the effective labour forces, s e and u e , where fig. shows a possible initial equilibrium. it is drawn on the assumptions that the health sector h is the most skill-intensive sector and sector is the least skill-intensive, that the incidence of illness is the same for both groups of workers, that the health sector allocates its output of health treatment in proportion to the numbers falling ill, and that treatment is equally effective across labour types. the maximum possible endowments of skilled and unskilled labour are s and u respectively (in the sense that there is no ill health and hence no need for health provision). inputs into the health sector are measured from o h , while those unable to work are measured from o w . the government health budget purchases s h and u h of labour inputs at given wages. at that level of health provision the numbers of potential workers remaining on the waiting list are s w and u w (and by virtue of the previous assumptions are in the same proportion as the economy's endowment ratio). the inner box then gives the skilled and unskilled labour available to work in the two tradables sectors. measuring inputs into sector from the north-east corner of this box and inputs into sector from the south-west corner allows us to determine the equilibrium at point a (where the production isoquants of sector and , not drawn for simplicity, are tangential, with a slope equal to the absolute value of the relative wage of unskilled to skilled labour). fig. illustrates the consequences of the government increasing the health budget in the case where there is no change in the overall endowments. inputs of skilled and unskilled labour in the health sector increase to s * h and u * h respectively. the provision of extra health care reduces the numbers on the waiting lists to s * w and u * w . the remaining labour inputs are allocated to sectors and which, given relative wages, yields equilibrium point c. the expansion of the health sector and the contraction of the waiting list change both the total and relative amounts of factors available to the two tradables sectors. it is convenient to decompose these into a "scale effect" (increasing the effective endowments of both skilled and unskilled labour due to improved health) and a "factor-bias" effect (changing the effective endowment ratio due to differences in skill-intensities between health and non-health sectors). splitting the changes into the two components allows us to draw some insights from standard trade theory results that have their origin in the seminal paper by rybczynski ( ) . since the health sector is, in this example, the most skill-intensive sector, its expansion will lead to a reduction in the skilled-unskilled labour endowment ratio available to the rest of the economy, so that, on the basis of the rybczynski theorem, the output of the relatively skill-intensive good (sector ) will fall and the output of the other good (sector ) will rise. this is the factor-bias effect, depicted in fig. by the move from a to b. the scale effect, from b to c, shows the effect of reducing the amounts of skilled and unskilled labour on the waiting lists, i.e., increasing effective labour supplies, which in this example increases the production of both goods. in the example of fig. it is evident that the net effect is a contraction of sector and an expansion of sector . however, it will also be evident that in general the effects on the tradables sectors depend on the ordering of factor intensities of the three production sectors and the endowment ratio, on the incidence of illness and on the provision and effectiveness of treatments for the two types of labour. for developed countries the available evidence suggests that the elasticity of effective labour supplies with respect to health care is small (and less than one) so that scale effects are small, as in fig. . hence, if we are willing to assume that health care is relatively skill-intensive and that factor-bias effects dominate, we expect an exogenous increase in health expenditures to benefit the unskilled-intensive sector and harm the skilled-intensive sector. whether the health sector is, in fact, more skill-intensive than all other sectors is an empirical question, as is that of whether the incidence of illness and the provision and effectiveness of health care are independent of labour type. in a multi-sectoral model with more than two factors, possibly health care-specific, and other real-life complexities the foregoing predictions are unlikely to be wholly true. nevertheless, these effects will still operate in the background and thus give a useful guide to the interpretation of the outcomes of such a model. the analysis is based on a comparative static cge model of the uk. the sam underlying the model has been constructed by augmenting the uk input-output supply and use tables for (office for national statistics, ), using data from non-working, children distribution and transport hse non-working, no children finance hse working, children public administration and defence hse working, no children health care (nhs, phc) other services table elasticity parameters in production. elasticity of substitution between factors of production ). an outline of the model is given below, with special detail on health and welfare effects. the cge model has in most respects a standard structure (e.g., francois and reinert, ) , the novelty coming from the explicit modelling of the health sector, comprising public (nhs) and private health care (phc), and its interaction with the rest of the economy through its differential impact across sectors, factors and household types (specified in table ). all sectors are perfectly competitive and multi-product industries. the production technologies are constant returns to scale, with production a leontief function of intermediates and value-added, itself a constant elasticity of substitution function of homogeneous factors of production. the accompanying substitution elasticities are displayed in table . household preferences are homothetic, with utility a cobb douglas (cd) function of consumption and savings. cross-border trade is treated using the assumption that the uk is a small open economy facing exogenous world prices for imports and exports, and accommodates 'entrepôt' trade, i.e., the re-exporting (re-importing) of imported (exported) goods, and transport and trade margins. in addition, the armington assumption (armington, ) is imposed on both production and consumption: goods produced domestically are destined for either the domestic market or for the export market, while consumers differentiate between domestic and imported varieties of the "same" good. the armington substitution and transformation elasticities are assumed equal to two in this model. the government uses its revenue from employment, production and consumption taxes to finance a fixed expenditure on goods (health care, public administration and defence, and other services) and a fixed amount of foreign exchange at the exchange rate to accommodate the trade surplus. the remainder of its budget is spent on income transfers to households (i.e., state benefits) which adjust so as to maintain the government account balance. households allocate the latter income and earnings from the supply of capital, skilled and unskilled labour to savings and consumption, assuming that only working households save. all factor and product markets clear through price adjustments. equilibrium in the capital goods market requires that the value of total savings equals the value of total investments. with the exchange rate as numéraire and the trade balance fixed in terms of foreign exchange, investments are savings-driven so that the model closure is neoclassical. we model the interaction between health care and effective labour supplies by the use of a non-participation rate for each type of labour. non-participation can be interpreted as "being on the waiting list", whereas participation implies employment in one of the sectors of the economy. the effective supply of factor endowments f by households h, fe hf , is specified in eq. ( ), and the waiting list for factor f by household h, wl hf , in eq. ( ). where < Á f < for labour types f ∈ l, l = {skill,unsk}; otherwise (for capital) Á f = . the waiting list is a fraction of total given factor endowments of household h (f hf ), and is defined positively only for labour (f ∈ l), whereas capital is always fully effective and fully employed. the fraction of people on the waiting list, i.e., the non-participation rate, is assumed to be identical across all households and is defined as a constant elasticity function of a health composite: where Á f∈l is a scale parameter, which measures the effectiveness of a given level of health care in treating and/or curing people and is calibrated so that < Á f∈l < . hc f∈l is a health composite and ε f∈l > is the waiting list elasticity, which measures the effectiveness of a change in health provisioning in treating and/or curing people. the latter is defined as the proportionate change in the size of labour type l's waiting list for household h following a change in the health composite, the health care composite for labour type l is a measure of the 'healthiness' or health status of this labour type and is a cobb douglas function of its public and private health care consumption: where ≤ l ≤ denotes the share of public health care in the health status of labour type l. g " denotes health care (commodity " " in table ) provided via the nhs -as given by real government consumption of health care, g j -and h c " "h represents the level of private health care provisioning -as given by the sum of household consumptions, c jh , of health care. given eqs. ( )-( ), waiting lists (effective labour supplies) are decreasing (increasing) in the health composites, at a decreasing rate. fig. illustrates (subscripts are ignored for simplicity). the contribution of public health care to the health status of skilled and unskilled labour, as measured by , is obtained from emmerson et al. ( ) . using family resource survey data for the period / - / , they calculate the percentage of adults with private medical insurance by social class. by applying population weights corresponding to each social class from the general household survey, the proportions of skilled and unskilled labour having private medical insurance are estimated at . % and % respectively, yielding a residual of . % and % of skilled and unskilled labour for whom health care is financed via the nhs. the latter serve as proxies for . the scale parameter Á is calibrated to the benchmark non-participation rate. its value is based on the barmby et al. ( barmby et al. ( , measure of sickness absence, calculated as the ratio of the number of hours absent due to sickness to the number of hours contracted to work. using labour force survey data, we find a fairly stable long-run average for the (yearly) sickness absence rate in the uk of around . %. another finding, corroborated by other studies (confederation of british industry, ; barham and leonard, ) , is that sickness absence varies by socio-economic characteristics. typically, the higher the wage and the higher the level of responsibility involved in the job, the lower the absence from work. illness-related absence from work is approximately . times higher for manual than that for non-manual workers. assuming that the non-participation rate in the base year for unskilled workers is . times that of skilled workers and postulating an overall non-participation rate of . % yields Á = . % for skilled and Á = . % for unskilled workers. the waiting list elasticity parameter, ε, is set to for both labour types, so that a % increase in health status leads to a % decrease in waiting lists. a value of seems reasonable since it gives health elasticities for skilled and unskilled labour of around . ( . and . for skilled and unskilled labour respectively), consistent with the scant empirical evidence that exists in this area. the results are tested for sensitivity to alternative values of the waiting list elasticities. the effects on welfare of higher health provision are two-fold: it directly increases the "well-being" of the population and indirectly improves welfare by increasing the size of the effective (i.e., "able to work") endowments of skilled and unskilled labour for use in non-health activities. accordingly, changes in household welfare are calculated from private household utility using the standard hicksian equivalent variation, to which the benefits from changes in nhs provisioning are added. for linear homogeneous preferences, the equivalent variation for household h can be written as: where u h and y h denote household utility and income respectively, and superscript and respectively refer to the equilibria before and after a particular shock occurs. assuming that each household receives a share˛h of the change in nhs provisioning (where ≤˛h ≤ , h˛h = ), the overall change in household welfare becomes: where gexp " " denotes benchmark government expenditure on health care, i.e., nhs care.˛h is calculated from each household's share in the total number of nhs general practitioner consultations. the resulting values are shown in table , together with the household shares in government transfers. adding up all household welfare changes including those related to nhs provisioning gives an overall welfare change for the uk economy of: we examine the effects of two types of policies which have identical implications for the nominal government budget on health care (the nhs budget), but differ in terms of their real budgetary impact due to differential price effects. experiments and simulate the impact of an increase in government health expenditures assuming mobile and health care-specific factors respectively. the introduction of health care-specific skilled labour and capital in the second experiment provides an alternative specification more suited to the short run. the former type consists of mainly doctors and nurses (approximately % of skilled labour employed in health care) and the latter consists of buildings and land (approximately % of capital employed in health care), and both earn a health care-specific remuneration. folland et al. ( , pp. - ) . these elasticities measure the proportionate change in the size of effective endowments of skilled and unskilled labour following a change in the health composite, and are calculated as (∂fe hf /∂hc f )·(hc f /fe hf ) = ε f ·wl hf /fe hf = ε f ·Á f /( − Á f ). the elasticity is higher for unskilled labour due to the fact that a relatively higher proportion of the unskilled suffer illness, so that health expenditure's "leverage" is greater for this labour type. using the same model specification as in experiment , experiment considers the alternative policy of importing medical services, i.e., health care-specific skilled workers consisting of doctors and nurses, in order to mitigate the shortage of highly skilled workers in uk health care (the effects of which have modelled in experiment ). on entering the uk, foreign doctors and nurses are assumed to become part of the existing domestic household structure, i.e., they are perfect substitutes for their domestic equivalents. this assumption takes into account that many of them plan to stay and will thus become permanent uk households in the long-term. health care-specific skilled wages are maintained at pre-immigration levels so that domestic workers are not worse off in nominal terms as a consequence of the policy. this assumption is representative of the uk situation, given that wages of health workers in the uk are essentially fixed in bilateral bargaining rounds between the department of health (constrained by the treasury) and the medical profession (represented by, among others, the british medical association). the experiment uses three alternative assumptions regarding the share of foreign worker income remitted abroad, adopting illustrative values of %, % and % respectively. varying the share of migrant income remitted will have differential welfare effects since remittances have to be compensated for by a rise in exports and/or a fall in imports so as to maintain the balance of payments. for the purpose of comparability, we carry out the experiments so that they will have identical implications for the nominal government budget on health care (i.e., the nhs budget). in experiment , it is assumed that an equivalent of % of domestic endowments of health care-specific skilled labour takes up the offer to migrate to the uk, so that the government budget on health care has to rise by . % (approximately £ . billion) to maintain their wages at pre-immigration levels in the uk health sector. this budget increase is taken as point of departure for experiments and . table summarises the key results. the additional nhs resources result in an increase in nhs provision and, via input-output linkages, increase the demand for and domestic production of pharmaceutical products and medical, precision and optical instruments. as a consequence health care, pharmaceuticals and instruments become slightly more expensive, which increases the costs to and hence reduces the size of private health care provision. are the sectoral effects consistent with the predictions from the theoretical model of section ? from the theory we expect that "on average" the relatively skill-intensive sectors ( , , and in table ) contract and the relatively unskilled-intensive sectors ( , , , , and in table ) and the health sector expand. the results reveal that most skill-intensive sectors do contract, albeit mildly, but that the pharmaceuticals sector expands. this suggests that, following a rise in the nhs budget and the consequent expansion of the health sector, the increased demand for intermediate inputs from this sector outweighs the reduced availability of skilled labour relative to unskilled labour. also, most of the unskilled-intensive sectors contract, apart from construction and the medical instruments sector. the latter's expansion is much more pronounced and, as before, is likely to be due to the intermediate demand effect from the health sector, rather than the increased availability of unskilled relative to skilled labour. the predictions of the theoretical heckscher-ohlin model thus do not carry over completely to the applied cge model, providing a strong argument for the use of the latter. the increase in public health care boosts the health of unskilled labour, its participation in the labour market, and reduces its waiting list by more relative to skilled labour, as the former is affected primarily by changes in public health care, whereas the latter also responds to changes in private health care provision which is more costly and less available. the changes in (effective) factor supplies and sectoral factor demands result in a (minor) fall in unskilled wages, whereas skilled wages and capital rents rise slightly. despite the fall in unskilled wages, the increase in labour market participation ensures that all households' income from unskilled (and skilled) labour rises. health care-specific skilled wages are fixed relative to the numéraire. since the consumer price index changes only marginally (by less than . % in absolute terms), fixing health care-specific skilled wages relative to the consumer price index would not alter our results. a reliable estimate of the share of foreign worker income remitted abroad cannot be obtained since the evidence on remittances by migrant workers itself is mixed and difficult to establish for three main reasons: ( ) a large proportion of remittances is transferred informally and is therefore not recorded in official statistics; ( ) remittance behaviour will depend on the characteristics of the migrants in question, for example, the skill type, income level, length of stay and the country of origin and ( ) it is unclear how much of the remittance flows can actually be attributed to health workers. in contrast with the standard neoclassical cge model closure, in which the current account balance is fixed and assumed equal to the capital balance, the modelling of migration and associated remittances implies that the trade balance has to adjust so as to maintain the balance of payments. note that our model does not explicitly account for other components of the capital account since it is focused on (the consequences of international trade in services on) the domestic economy. note that the government closure is such that transfers to households adjust so as to maintain the government balance ceteris paribus changes in government tax revenues so that households bear the brunt of the adjustments. however, in cge modelling there are many sources of funds that are fungible and an infinite number of distortionary taxes that may be introduced, which all are politically difficult to implement. the main point in cge modelling and more generally in modern welfare economics is that, as long as overall welfare gains arise, losers may be compensated by winners so that it is possible to undertake a potential pareto-improving redistribution (johansson, ) . when there are many sectors in a heckscher-ohlin model, the rybczynski theorem becomes a "correlation". as falvey ( ) states, "there is a tendency for an increase in those outputs using intensively those factors whose endowments have risen and a decline for others." further uncertainty about outcomes in induced by the existence of intermediate inputs. the uk health sector is relatively skill-intensive, though its skill-intensity is only just above the endowment ratio, so we would expect the "correlation" to be low. the fall in government transfers to households, which follows from the assumed balanced government budget, leads to reductions in income for working households with children, but relatively more so for pensioners and non-working households. only childless working households, who own most of skilled labour endowments and rely least on government transfers, gain slightly. adjusting private welfare losses for changes in nhs provisioning reduces welfare losses, with pensioners and non-working households losing, whereas working households gain. nevertheless, in total welfare increases by £ . billion (a gain of . % relative to the original level of welfare). this simulation implements the same policy as in experiment , but accounts for the fact that a large part of the labour and capital employed in health sector are, respectively, highly trained or highly specialised and therefore arguably specific to health care and immobile. key findings are that, unsurprisingly, the presence of health care-specific skilled labour and capital constrains the production expansion of health care and related sectors. an . % increase in the nhs budget leads to a rise in real levels of nhs provisioning of less than half of that, the remainder of the budget being spent on higher wages of highly skilled doctors and nurses and capital rents, and resulting in higher unit costs (and a contraction in private care). as a consequence, indirect welfare gains from improved health on effective labour supplies, and direct welfare gains from improvements in well-being, are lower compared to the previous experiment. non-working households and pensioners lose by more and working households gain by less, cutting the total welfare gain by %. this simulation presents the results of a policy of importing health care-specific skilled workers (i.e., doctors and nurses), which addresses the bottleneck of not being able to hire additional workers of this type in the domestic market in the short run. in the absence of remittances abroad, the specified rise in the nhs budget which is targeted towards the immigration of foreign health care-specific skilled workers, yields a rise in real levels of nhs provisioning of . %. this is less than in the first experiment since the wages of the domestic and foreign workers of aforementioned type are sustained at benchmark levels, thereby increasing the unit costs of health care provisioning (and reducing private sector production). the direction of effects across sectors, factors and households are nevertheless similar to those in experiment . whereas direct and indirect welfare gains from the rise in nhs provision levels and health improvements are lower, government transfers to households need to fall by less to finance the expansion of the nhs budget due to higher government tax revenues. thus, in the absence of remittances, working households and, to a lesser extent, non-working households gain, and only pensioners lose. remittances abroad reduce welfare gains for some groups and increase welfare losses for the others so that, as in the previous experiments, pensioners and non-working households lose and working households gain. the total welfare gains however still exceed those of the generic rise in the government budget, certainly if one compares experiments with the same model specification (i.e., experiments and ). this can be explained by the fact that the immigration of doctors and nurses in the third experiment addresses the bottleneck of the scarcity of this type of labour in the uk, while increasing the nhs budget in the second experiment aggravates it (by putting upward pressure on the wages of doctors and nurses). finally, a remark on the sign of the changes in total private welfare versus the changes in overall welfare recorded for all simulations is in place here. the negative sign of the former and the positive sign of the latter suggests that the indirect welfare gains from improved health on effective labour supplies are relatively small for the uk and that most of the overall welfare gain is generated by direct welfare gains from improvements in well-being. this is a direct result of the rather conservative estimates used for the waiting list (and health) elasticities, which we imposed since for the uk as a whole we assume that we are "on the flat of the health production curve". if we were to model a specific health care problem and alternative health interventions with a higher marginal return, or if we were to take a different country where the health system is still relatively underdeveloped and the marginal impact of an increase in health provisioning is high, waiting list (and health) elasticities may well be higher, increasing the indirect welfare gains from improved health on effective labour supplies so that total private welfare gains may become positive. this is illustrated below in the sensitivity analyses. sensitivity analyses for the elasticities of substitution and transformation show that the results of the counterfactual simulations are relatively robust: although sign changes do occur for some variables, the impact of changing the respective elasticities upon overall welfare is negligible. varying the waiting list elasticities for skilled and unskilled labour, which govern the indirect health effects of improved health on effective labour supplies, does however affect the results considerably: generally, in the presence of increasingly strong skill-neutral health effects, the expansion of nhs care, although representing an immediate cost to society, yields substantial welfare gains in the long-run through increases in effective labour supply and production, and by enhancing the tax revenue of the government, which benefits both working households (in terms of their wage income) and non-working households (in terms of their receipt of state benefits). specifically, a waiting list elasticity for both skilled and unskilled labour of at least . in experiment , . in experiment and . in experiment (taking the most negative scenario of % remittances), i.e., an approximate doubling of the waiting list (and health) elasticity, generates positive total private welfare gains. moreover, in experiments - (scenario of % remittances) total uk welfare rises for relatively low values of the waiting list elasticity (lower boundary values of . , . and . respectively) so that the main results continue to hold. these results suggest that if we were to employ the model for a specific health care problem and alternative health interventions, or for a different country, then we could get quite different results, depending on, inter alia, the incidence of illness (which determines the number of people treated by the health sector and so the number of healthy workers that could be 'produced') and the 'efficiency' of the health sector in producing healthy workers. this paper seeks to determine the macro-economic impacts of changes in health care provision, while recognising the simultaneous effects of consequent changes in health on effective labour supplies and the resource claims made by the health care sector. the resource allocation issues have been explored in theory, by applying the standard rybczynski theorem in a low-dimension heckscher-ohlin framework and, empirically, by developing a cge model, calibrated to a purpose-built dataset for the uk. using the theory, the impact of an expanding health sector on the outputs of non-health sectors was shown to depend on the sign and magnitude of a scale effect of increased effective labour supplies and a factor-bias effect of changes in the ratio of skilled to unskilled labour. the net effects generally are indeterminate. given that effective labour supplies are relatively inelastic with respect to health care provision in developed countries since they are "on the flat of the health production curve", factor-bias effects may dominate so that an increase in health care provision, which is relatively skill-intensive, may "on average" result in an expansion of the relatively unskilled-intensive sectors and a contraction of the relatively skillintensive sectors in the long-term. these predictions were generally not found to hold in the cge model due to added-real-life complexities, most notably the presence of intermediate inputs. this is a strong argument for the use of an applied model in addition to a theoretical model. using an applied cge model for the uk, which in addition to the labour market effects also incorporates the direct impact of health provision on the "well-being" of the population, we have compared the nominally equivalent policies of increasing the nhs budget under the assumptions of mobile and health care-specific factors and the immigration of foreign skilled workers (doctors and nurses) at the current wage with one another. the main findings are that the increase in the nhs budget, while drawing away resources from its private counterpart and from other non-health related sectors, leads to an overall welfare gain through increased worker incomes and, more importantly, direct increases in population well-being. the presence of health care-specific skilled labour and capital reduces the overall welfare gain by about two thirds, as over half of the specified budget rise is absorbed by higher wages and rents. this suggests the importance of tackling short-term rigidities in the health sector. the shortage of highly skilled workers may in the short-term be addressed via the recruitment of highly skilled foreign doctors and nurses. this policy was found to yield the highest overall welfare gains, even if all foreign worker income is remitted abroad, since government transfers need to fall by less to finance the health care budget increase due to higher government tax revenues. it is, however, unlikely to be a desirable policy given that many migrant workers come from developing countries which need their own educated staff. consequently, in the long-term increasing the number of medical school places in the uk may be a more suitable policy response. the sensitivity of the results to the waiting list (and health) elasticity for skilled and unskilled labour suggests that if we were to employ the model for a specific health care problem and alternative health interventions, or for a different country, then we could get quite different results, depending on, inter alia, the incidence of illness and the "efficiency" of the health sector in producing healthy workers. in our model these impacts are relatively small since in the uk we assume that at the aggregative level we are on the "flat of the health production curve". interesting applications in this respect are to apply the framework developed in this paper to the perspective of a developing country with a relatively underdeveloped health care system and a high burden of disease (e.g., a country in sub-saharan africa) or to model the impact of an epidemic, such as influenza, and alternative policy options in a developed country context, such as the uk, so as to test the ability of the health system to cope with a disease outbreak. our model may be extended in various ways. firstly, incorporating long-term population processes (births, deaths, transitions from "young" to "working" to "retired") in a dynamic (overlapping generations) model would link our analysis to the issue of ageing. secondly, the modelling of health-related gains in "well-being" in the model, which at the moment are estimated rather conservatively at the real value of nhs service provision, may be improved using for example the literature on happiness (clark and oswald, ) . thirdly, it could be made more realistic by increasing the level of disaggregation in health care in terms of, for example, types of treatments and care so as to assess the allocative efficiency of current spending, and types of health care staff and equipment to allow for differential substitution between them. a theory of demand for products distinguished by place of production hiv/aids, human capital, and economic growth prospects for mozambique. africa region working paper series . the world bank the macro implications of hiv/aids in south africa: a preliminary assessment the hiv/aids pandemic in south africa: sectoral impacts and unemployment hiv/aids and labor markets in tanzania. tmd discussion paper social spending, human capital and growth in developing countries: implications for 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survey. the stationary office, london. office for national statistics the economic impact of health care provision: a cge assessment for the uk the economic impact of medical migration: a receiving country's perspective assessing the macroeconomic impact of a healthcare problem: the application of computable general equilibrium analysis to antimicrobial resistance adjustment, liberalization and welfare, in presence of health and education externalities: a cge applied to benin health, nutrition and economic development the interrelationship between income, health and employment status the macroeconomic management of foreign aid: opportunities and pitfalls health, nutrition and prosperity: a microeconomic perspective planning for basic needs: a basic needs simulation model applied to kenya integration of health care into a multi-sector model: with a quantification for tanzania. discussion paper the health of nations: a survey of health-care finance the authors are grateful to joe francois, adam blake, dave whynes, rod falvey, doug nelson, eddy van doorslaer, kirsten rohde and an anonymous reviewer for their helpful comments and suggestions. the paper is based on the first author's ph.d. thesis at the university of nottingham (rutten, ) . preliminary versions of this paper were presented at the ecomod international conference on policy modeling in istanbul, the third gep postgraduate conference at the university of nottingham, the res annual conference in nottingham and the health economics seminar series at the erasmus university rotterdam. the responsibility for any remaining errors or infelicities remains with the authors. this paper presents the opinions of the authors, and is not meant to reflect the opinion or official position of any institution with which they are or have ever been affiliated with. key: cord- - jgusov authors: dignard, caroline; leibler, jessica h. title: recent research on occupational animal exposures and health risks: a narrative review date: - - journal: curr environ health rep doi: . /s - - - sha: doc_id: cord_uid: jgusov purpose of review: in the last year, an increasing number of studies have reported on methicillin-resistant staphylococcus aureus (mrsa) transmission in africa and asia and in migrant workers. we reviewed original research on occupational health and safety of animal workers published from january , , through june , , with a targeted focus on infectious disease studies published in these populations. recent findings: studies focused on occupational exposures to infectious agents, dust and allergens, pesticides, and occupational injury. research on zoonotic mrsa used whole genome–sequencing technologies to evaluate transmission in africa and asia. swine worker exposure to porcine coronavirus and emerging influenza a viruses was documented in china. s rna amplicon sequencing identified distinct microbiota compositions in households with active animal farmers. multiple bioaerosol exposures were assessed for industrial dairy workers. occupational injury studies highlighted the struggles of latino animal workers in the usa. summary: these studies highlighted the global expansion of zoonotic antibiotic resistance and identified novel occupational zoonoses of concern. the integration of microbiome assessment and compound mixtures into the evaluation of dust and endotoxin exposures for animal workers marks a new direction for this work. occupational exposure to animals is associated with a myriad of health and safety risks, including zoonotic infections, occupational injury, respiratory disease, and cancer [ ] [ ] [ ] [ ] . in the usa, food animal workers have elevated workplace mortality and injury rates compared with workers in other industries, highlighting the occupational risks involved in the profession [ ] . in the last years, research on zoonotic infection risk has dominated the occupational health literature on the animal workforce, highlighting in particular exposure risk to drugresistant bacteria and influenza viruses and subsequent transmission from workers to the general public [ ] [ ] [ ] . in the last years, industrialization and corporate consolidation have characterized the food animal production industry, first in the usa and europe and then globally [ , ] . these trends have fundamentally altered occupational exposures for the food animal workforce, by increasing and intensifying specific occupational exposures that impart health risks [ ] . for workers, the intensity of animal exposures has increased, as industrial farms can hold tens of thousands of animals on site. the dramatic increase in the number of animals housed together in confinement contributes to intensified worker exposure to animals and animal products, including allergens and fecal materials [ , ] . notably, the introduction of antibiotics into animal production-in an effort to facilitate the higher carrying capacity of industrial farms-has resulted in worker exposures to antibiotic-resistant bacterial infections [ ] . since , research on zoonotic methicillin-resistant staphylococcus aureus (mrsa), particularly the livestock-associated mrsa strains st and cc , have identified important public health concerns stemming from the misuse and overuse of these antibiotics in agriculture [ ] [ ] [ ] . likewise, the h n epidemic in poultry in asia in the mid- s and the h n swine flu human pandemic, highlight the role of industrial systems in the ecology of pandemic influenza [ ] [ ] [ ] . the emergence and re-emergence of zoonotic pathogens with potential to infect humans remains a critical public health issue, and animal workers are at the front lines [ ] [ ] [ ] . the demographics of this workforce have also changed significantly in recent decades, with latino and immigrant workforce currently dominating the worker population in the usa. this change has resulted in additional challenges for the workforce, including language barriers, immigration status concerns, stagnant and falling wages, and other socioeconomic and political stressors [ ] . the relationship between these stressors and occupational injury and mental health has been documented in recent years [ ] [ ] [ ] [ ] . many animal workers experience occupationally induced respiratory disease, including allergies, asthma, and rhinitis [ , ] . high levels of inhalable dust and endotoxins are considered the primary exposures of concern in regard to respiratory disease; however evaluating these often complex mixtures-including animal products, dust, pathogens, and chemicals-is typically limited to single-compound analyses. as a result, much remains unknown about the etiology of occupational respiratory disease among animal workers. across agricultural industries, the use of pesticides is associated with a variety of health risks, including reproductive, dermatological, and neurological problems as well as cancer [ ] [ ] [ ] [ ] . pesticide use is common among animal facilities, particularly those that engage in both crop and livestock production, yet pesticide exposures have received limited scrutiny to date in research on animal workers. on both industrial and small-scale animal farms, chemical disinfectants are used to prevent transmission of infectious agents and may result in health concerns for workers [ , ] . while the biosecurity literature has promoted the use of disinfectants to prevent disease transmission, health risks associated with worker exposure to these compounds are largely unstudied. in this manuscript, we review occupational health studies published in the last months in the peer-reviewed literature focused on the health and safety of animal workers. our intention was to highlight important findings and new directions for this research area. we searched pubmed, web of science, and google scholar for terms and keywords relating to occupational health and animal exposure, including combinations of the following worker and health-specific terms: "food animal worker", "animal worker", "industrial animal worker", "animal farmer", "occupational injury", "occupational health", "health and safety", and "occupational safety". a date range of january , , through june , , was included so as to maximize identification and in-depth discussion of recent research. a total of distinct manuscripts were identified upon initial search. following review by two researchers (c.d., j.h.l.), these papers were reduced to manuscripts of relevance to the current topic. these papers included three review manuscripts and original research studies. we included the reviews in our analysis because they provide important insight and expert consensus as to the direction of important fields (biosecurity for live bird market workers; respiratory exposures and disease among food animal workers; and effectiveness of health and safety trainings and interventions for latino animal workers). the manuscripts were organized in an excel spreadsheet and read by two researchers. a narrative synthesis approach was used to extract central themes, findings, and conclusions. based on our a priori knowledge of the field and an assessment of other recent manuscripts in the literature, we identified manuscripts we believed to be of elevated significance to readers engaged in animal worker health and safety work and research, and we discuss those studies in greater detail. the manuscripts published during this -month period were predominantly in the following topic areas: infectious disease and pathogen exposures; respiratory disease and irritants; pesticide and chemical exposures, including neurological toxicants and carcinogens; and occupational injury. below, we summarize the key findings from manuscripts published in each of these topic areas, highlighting the papers that in our opinion are of greatest importance for the field. the majority of manuscripts identified in our review ( / ; %) were focused on animal worker exposure to infectious agents, zoonotic pathogen carriage or infection within this workforce, or pathogen contamination of the work environment. the infectious disease papers are summarized in table . the reviewed manuscripts documented the identification of livestock-associated mrsa in animals and humans in regions around the world and in animal-exposed professions in which mrsa had not previously been assessed. a study in nigeria identified low prevalence of la-mrsa among abattoir workers ( . %) and distinguished a diversity of s. aureus spa types in the work environment, including a novel spa type (t ) [ ] . the first published study of la-mrsa among workers and livestock in trinidad identified a low prevalence among animals (< %) and no worker carriage, indicating limited transmission in this country [ ] . a case study of mrsa among swine and workers on an australian swine farm where workers were affected by skin lesions identified high odds of mrsa nasal carriage among the workers (or . ) and a dose-response relationship of mrsa nasal carriage in association with duration of time spent working with pigs [ ] . a study in italy reinforced the elevated prevalence of st among industrial swine (approx. %) and swine workers ( %) in that country and highlighted a component of the production cycle (fattening) in which workers had higher risk of exposure [ ] . cuny and colleagues assessed mrsa nasal colonization among butchers and food preparers in germany to evaluate whether these persons with contact with raw meat were colonized with livestock-associated mrsa, and found limited evidence of colonization (< %) [ ] . these studies continue to expand our knowledge of the distribution of livestock-associated mrsa, both by industry and by geographic region. whole genome-sequencing (wgs) technology was used to elucidate transmission pathways in two studies conducted in africa. amoako and colleagues took a comprehensive approach and used wgs to evaluate mrsa along the "farm to fork" continuum in the intensive poultry industry in south africa [ ] . the authors evaluated samples collected from the farms, transport vehicles, slaughterhouses, and retail outlets, as well as fecal and nasal specimen from workers along the production process. the authors document the widespread distribution of mrsa clone st -cc _t -sccmec_type_ivd ( b) throughout the production cycle. they hypothesize that the multidrug resistance of this clone is mediated by mobile genetic elements, due to the similarity of resistance patterns between the human and animal specimen. the identified prevalent clone is considered both nosocomial and community-associated, highlighting the public health risks associated with the poultry industry in south africa. this work and the study in cameroon, detailed below, are of relevance due to the rapid intensification and expansion of industrial food animal production into africa and the limited research to date on the public health consequences of this industrial growth. a second study in africa used wgs to identify the genetic lineage of mrsa isolates from swine slaughterhouses in south africa and cameroon [ ] . these authors found approximately % prevalence in pigs in south africa but a low prevalence in cameroon (< %), with no workers colonized in either country. all isolates were st , a distinction from the amoako study. these findings highlight potential differences in mrsa carriage by species and/or region and also suggest that production or environmental containment practices may differ among countries and corporations in relevant ways for public health. chen et al. used wgs to identify whether cc , the predominant livestock-associated mrsa strain in asia, was associated with pathogenicity in humans [ ] . the authors screened mrsa isolates from a national database in taiwan and found cc had a low prevalence ( . %); however, these isolates were associated with invasive disease, including bacteremia leading to death and osteomyelitis in four of the eight identified cases. the remaining four cases were associated with mild disease or colonization without disease. of note, only two of the eight cases had documented exposure to pigs, considered the main cc reservoir in the region. this important paper highlights two core concepts: ( ) while rare in humans, cc may be associated with significant pathogenicity in humans, including death and ( ) nosocomial or community transmission for this pathogen should be considered. like the african studies, this paper elucidates the public health risks from animal work and highlights the potential role of animal workers at the front lines of exposure to zoonotic pathogens of broader health concern. other antibiotic-resistant bacterial infections escherichia coli (e. coli) recovered from swine workers and pigs in northern vietnam, a region characterized by rapid growth in industrial swine production and heavy agricultural antibiotic usage [ ] . esbls are of particular concern because these genes are encoded by plasmids that are easily transferred across bacterial species, potentially resulting in widespread antibiotic resistance. the authors observed high prevalence of ctx-resistant e. coli among both workers and pigs ( % of pig workers and % of pigs) on farms studied. esblproducing e. coli was detected from more than % of both pigs and farms. this paper highlights significant concern regarding potential spillover of drug-resistant bacteria from swine to humans in this region, as well as the likelihood of dissemination of the esbl mges. research during this period focused on zoonotic influenza of multiple subtypes, including the emerging influenza d virus. ma et al. published findings from a longitudinal study of swine workers, swine, and environmental sampling in china [ ••] . notably, in this study, workers were monitored for influenza-like illness along with surveillance sampling, so as to identify active symptoms associated with infection. approximately % of workers with ili were positive for influenza a virus, with more than % of those infected with a putative swine lineage virus. additionally, high concordance was noted between a(h n )pdm -like h n viruses isolated from workers with ili and iav circulating among swine, indicating species crossover. a second study, led by borkenhagen et al. identified influenza b and influenza d viruses in swine worker nasal passages during a surveillance study in malaysia [ ] . the authors also recovered porcine circovirus in worker nasal specimen as well as in pig specimen, indicating zoonotic concern associated with this viral pathogen of growing concern in asia. we would also direct readers interested in zoonotic influenza emergence to two valuable review papers published in the last year this topic, by zhou et al. and bailey et al [ , ] . animal worker exposure to hepatitis e virus (hev) was explored in two notable papers, both of which extended the prior paradigm of hev research to include new populations or production specifics. a study in hubei, china, identified elevated seroprevalence among rabbit slaughterhouse workers compared with community controls and observed a doseresponse relationship between increasing seroprevalence associated with duration of employment [ ] . khounvisith and colleagues evaluated hev seroprevalence among commercial pig workers in laos, a region with hev endemicity among swine [ ] . the authors observed % of workers were hev seroprevalent, compared with % of controls, and workers exposed to piglets during the growth process were at elevated risk. other authors highlighted additional emerging zoonotic viral pathogens in the food animal workforce, including a report of brucellosis among sheep farmers in egypt and knowledge and biosecurity practices among indian animal farmers about rabies [ , ] . msimang and colleagues reported on rift valley fever seroprevalence among animal farmers and veterinarians in south africa, concluding that infection with this re-emerging pathogen is likely notably higher than previously recognized and under-diagnosed in the region [ ] . we identified eight original research papers and one review study focused on topics related to respiratory disease, exposure to allergens and dust, and airborne bacteria among animal workers. these papers expanded the literature in two core ways: ( ) a focus on combined and interacting respiratory exposures, rather than single-exposure assessments and ( ) the use of s rna amplicon sequencing technology to evaluate house microbiota in farmer's homes and correlating these data to endotoxin levels. key papers are discussed below. davidson et al. conducted personal exposure monitoring of bioaerosol exposures, including inhalable dust, endotoxin, -hydroxy fatty acids, muramic acid, ergosterol, and ammonia among workers at large dairies in the western usa [ •] . this paper marks one of the early studies to consider multiple, and interacting, respiratory exposures in this population. the authors conclude that a majority of these workers were exposed to endotoxin concentrations that exceed recommended guidelines ( %). workers were also exposed to inhalable dust and ammonia at levels above guidelines. the authors also evaluated the correlation between pairs of these exposures by different dairy tasks, another novelty of this work. lee et al. used s rna amplicon sequencing to evaluate bacterial composition of dust samples recovered from households of active and former farmers recruited in the agricultural lung health study, a nested study of the agricultural health study in north carolina and iowa [ ••] . current farming was a significant predictor of the composition and diversity of house dust microbiota. animal farming was uniquely associated with firmicutes and proteobacteria phyla, with bacillaceae, bacteroidaceae, xanthomonadaceae, streptococcaceae, and lactobacillacae also identified in dust specimen from homes with animal farmers. the authors identified taxa associated with endotoxin concentration. asthma status was not associated with bacterial diversity or composition. this paper is notable for its integration of traditional exposure assessment approaches to endotoxin and s rna amplicon sequencing technology for evaluating microbiota, and for contributing detail to our understanding of household-level exposures experienced by animal workers and their families. other notable manuscripts this year included: a study of bacterial and fungal exposures among portuguese veterinarians, exposures to ammonia, vocs, and fungus among swine workers during the summer and winter seasons in poland, and a study from australia of worker exposure to asthmagens derived from animals or fish/shellfish (el zaemey et al.) [ ] [ ] [ ] . the latter study was notable for its large sample (n = ) and its comparison of farmers and animal workers to community controls in a national agricultural study. additionally, an excellent consensus paper published by the european academy of allergy and clinical immunology highlights the state of the literature on respiratory disease and animal workers, specifically food processing workers, in europe, focusing on all elements of the food production chain [ ] . studies of pesticide and chemical exposures among animal workers highlighted pesticides usage in livestock production may increase the risk of parkinson's disease (pd) among farmers. while this relationship has been previously assessed in crop farmers, the identification of animal farmers as a population at risk due to shared exposures is a notable contribution of work from this year. pouchieu and colleagues evaluated the risk of pd among both livestock and crop farmers in france exposed to pesticides in the agrican cohort [ ] . the crop matrix pestimat was used to evaluate exposure to active ingredients and duration of lifelong use, and the implementation of this matrix again reinforces the interest in evaluating complex and realistic mixture scenarios for worker exposures. in this study, cattle workers in particular had an elevated risk of pd, with dithiocarbamate fungicides, rotenone and the herbicides diquat and paraquat identified as compounds of concern for this occupational group. additionally, further studies elucidate carcinogenic compounds beyond pesticides that animal workers may be exposed to, highlighting cancer research as an underexplored area for consideration in this population. darcey and colleagues conducted a cross-sectional study to evaluate exposure to solar radiation, diesel engine exhaust, and solvents among australian farmers [ ] . exposure to these carcinogens was highest for farmers with mixed livestock and crop production, again highlighting unique risk profiles for workers who engage in multiple agricultural activities. hoffman et al. evaluated serum immune markers in a subset of ahs participants who were swine farmers to consider an immunological explanation for the inverse relationship between swine farming and lung cancer, which is hypothesized due to endotoxin exposure [ ] . the authors observed that macrophage-derived chemokine (ccl ), which is believed to contribute to lung carcinogenesis, was lower in swine farmers compared to cattle farmers with a % reduction in levels among farmers at the largest farms (> head), suggesting a dose-response relationship. these manuscripts highlight the complex health effects associated with occupational animal exposure and indicate how emerging technologies and personal monitoring can inform the biological basis of epidemiologic observations. reviewed manuscripts largely focused on the experiences of latino immigrant and migrant farmworker populations in the usa, who comprise a majority of the us food animal workforce. we note a limited number of peer-reviewed original research publications on occupational injury during the short period of our review. we identified four published epidemiological studies of occupational injury in the animal workforce as well as three studies evaluating effectiveness of injury prevention training. a small study conducted in missouri examined self-reported injury and health status among latino immigrant workers. their results indicated a high prevalence of workers rating their health as fair or poor, along with high prevalence of occupational injury [ ] . clouser and colleagues found that occupational injury was more likely for latino farmworkers in the usa if they self-reported work stress, supervisor unfairness, or supervisor inability to speak spanish [ ] . these findings reinforce that immigrant latino and migrant workers in the animal industry need additional resources and supports to successfully mitigate injury risk. bush and colleagues evaluated the causes of missed work among a sample of latino horse workers in the usa in an attempt to evaluate the causes of occupational illnesses [ ] . the authors found that having at least one child, poor selfrated health, and elevated stress were associated with missed work, highlighting the intersecting role of personal and workrelated factors for these workers. an assessment of osha's dairy-focused local emphasis programs (leps) in wisconsin and new york by liebman et al. found that the osha's recent initiative to reduce injury and hazard in the dairy industry improved farmers' ability to recognize occupational hazards [ ] . the authors found that the leps motivated participating dairy producers in these two states to address hazards, such as correct signage, repairs and fit for ppe, and manure management and also encouraged workers to advocate for health care needs. rodriguez et al. evaluated the effectiveness of delivering health and safety training using mobile platforms to us dairy workers with limited english proficiency [ ] . this method was successful, with workers enrolled (n = ) demonstrating a % mean increase from pre-to post-test knowledge of workplace safety practices (p < . ). this paper is of particular note given the proliferation of smartphones and the increasing proportion of the food animal workforce with limited english proficiency. rodriguez and colleagues noted that more than / of the participants in their study spoke a central american indigenous language and were able to receive training through smartphone applications and translation, highlighting the power of this technology to reach many workers with necessary education. caffaro and colleagues conducted a literature review on occupational safety and health training programs addressing migrant farmworkers, including animal workers, to determine the effectiveness of the standard programs in place [ ] . the majority of the reviewed studies found the training programs to be ineffective, with no or little difference in injury outcomes with or without the standard training programs. the authors recommended an increase in participatory approaches and multilingual offerings so as to improve the effectiveness of these programs for migrant workers. continued efforts to evaluate the effective means of developing and delivering injury prevention and health promotion training to the changing and diverse food animal workforce is an important theme of study. research in and early on occupational health and safety topics involving animal workers highlighted the risks and interventions associated with infectious disease, respiratory disease, chemical exposure, and occupational injury. in the realm of infectious disease, these studies identified an expanding, and concerning, geographical distribution of mrsa as well as novel transmission pathways. the expansion of mrsa into africa is of particular note, as the continent has witnessed rapid intensification of food animal production and demand for industrial meat products in recent years. given the known consequences of unregulated antibiotic usage in animal production for public health and the emergence of la-mrsa, surveillance, and regulation of la-mrsa in this region is a critically important direction for future research. in the absence of antibiotic stewardship, interventions to protect workers from zoonotic antibiotic resistant infections-building on the experiences in europe and the usa-would improve african worker health. likewise, the discovery of mrsa strain cc among human patients in taiwan, and the association of this strain with severe illness and death, signifies an important direction for future research. while highly prevalent in livestock populations in asia, cc has not been considered a human pathogen of significance. chen et al.'s paper should reignite interest in this strain as an important, if rare, contributor to severe illness in humans, with surveillance targeting food animal workers at the front lines of exposure. research on zoonotic influenza viruses identified species spillover from swine farming into the food animal workforce, highlighting the importance of this pathway, and this industry for surveillance and pandemic influenza prevention. bailey and colleagues nicely highlight the recent expansion of zoonotic influenza research, notably the discovery of zoonotic influenza d virus, in their review on this topic [ ] . continued research on influenza transmission at the humananimal interface in food animal production remains a critically important area for continued work. likewise, research on behaviors and practices that affect worker exposure, as well as intervention evaluation studies, are central. studies of respiratory irritants and disease integrated new technologies into multi-exposure assessments, including s rna amplicon sequencing technology. the incorporation of metagenomics approaches will likely mark exposure assessment studies in the future, given the relevance of these techniques in other research areas and the opportunities to shed new light on existing occupational health problems. in particular, microbiome analyses have the potential to highlight the relationship between occupational exposures and chronic conditions, such as cancers and respiratory diseases, whose etiology has remained elusive. gene expression studies could elucidate pathways of respiratory irritation among highly exposed workers, with relevance for both the food animal workforce and also the general population. as whole genome sequencing techniques have clarified the role of zoonotic pathogens in the emergence of novel pathogens, such as livestockassociated mrsa and zoonotic influenza viruses, genetic, and genomic techniques hold significant power to clarify pathways of occupational disease for the food animal workforce. this is an important area for future research. consideration of pesticide exposures in animal workers, and multiple exposures between crop and animal farmers, also reflects the emerging interest in complex mixtures analyses in occupational exposure assessment. while studies reviewed here did not formally engage mixtures analytic approaches (such as weighted quantile sum regression or lagged kernel machine regression) davidson and colleagues illustrated the value of combined metrics in exposure assessment studies for food animal workers. given the complex mixtures of pathogens, allergens, toxicants, and other compounds that food animal workers are exposed to on the job, the application of mixtures methods to occupational health studies of food animal workers is an important next step for the field. these techniques may hold specific relevance for cancer endpoints of relevance to this workforce, whose etiologies are potentially multifactorial and have remained rather elusive to date. the predominance of research on latino and migrant worker injury and safety reflect changing demographics in the animal industry over the last years. food animal production in the usa, including both live animal production as well as processing, remains in a period of demographic transition, with the industry increasingly facing a reckoning between the needs and demands of the immigrant and us-born workforce. as segments of the workforce become increasingly immigrant-based, the specific training needs, and injury experiences of these workers become central. studies on the effectiveness of safety training and intervention that target the specific needs and experiences of this segment of the workforce are critically important to reducing morbidity in this industry. likewise, future research that highlights the health experiences and needs of us-born food animal workers, who currently experience wage stagnation and significant social stressors in many regions of the usa, should also be at the forefront. the occupational injury implications of the industry's interests in increased line speeds and also automation also remain an important area for future work, so as to inform regulations and protect workers. food animal work remains a complex and often dangerous occupation. research in and beyond would best suit the needs of this workforce by continuing to highlight pathogens of concern, identify regulatory and intervention opportunities to reduced occupational pathogen exposure, integrate emerging microbiome and genomic technologies to more fully elucidate occupational disease pathways, and evaluate injuryprevention techniques specific to the demands and realities of the industry. funding information support for this work was provided by cdc/ niosh k oh (jhl) and williams college center for environmental studies (cd). antimicrobial-resistant bacteria: an unrecognized work-related risk in food animal production particulate matter, endotoxin, and worker respiratory health on large californian dairies environmental exposure and health effects from concentrated animal feeding operations lung cancer risk in 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malaysia the authors identified cross-species transmission of human-adapted h n viruses and swine-adapted h n viruses in both swine and swine workers in china, highlighting continued pandemic influenza risk from swine production in this region. the authors also noted symptomatic influenza-like illness among workers using a longitudinal design sero-diagnosis of brucellosis in sheep and humans in assiut and el-minya governorates. egypt challenges to human rabies elimination highlighted following a rabies outbreak in bovines and a human in high seroprevalence of hepatitis e virus in rabbit slaughterhouse workers high circulation of hepatitis e virus in pigs and professionals exposed to pigs in laos rift valley fever virus exposure amongst farmers, farm workers, and veterinary professionals in central south africa methicillin susceptible staphylococcus aureus (mssa) of clonal complex cc , t from infections in humans are still rare in germany effectiveness of market-level biosecurity at reducing exposure of poultry and humans to avian influenza: a systematic review and meta-analysis the continual threat of influenza virus infections at the human-animal interface: what is new from a one health perspective the authors conducted personal exposure monitoring for multiple airborne irritants and toxins among dairy workers in the western us, and considered exposureby-exposure mixtures, setting the stage for future work the authors evaluated microbial composition of household dust using s technology and compared findings to endotoxin levels. this study marks an early foray into microbiome research for understanding health effects associat organic dust exposure in veterinary clinics: a case study of a small-animal practice in portugal occupational exposure level of pig facility workers to chemical and biological pollutants prevalence of occupational exposure to asthmagens derived from animals, fish and/or shellfish among australian workers food processing and occupational respiratory allergy-a eaaci position paper pesticide use in agriculture and parkinson's disease in the agrican cohort study prevalence of exposure to occupational carcinogens among farmers industrial hog farming is associated with altered circulating immunological markers self-reported occupational injuries and perceived occupational health problems among latino immigrant swine confinement workers in missouri associations of work stress, supervisor unfairness, and supervisor inability to speak spanish with occupational injury among latino farmworkers missed work due to occupational illness among hispanic horse workers an overview and impact assessment of osha large dairy local emphasis programs in new york and wisconsin using mobile technology to increase safety awareness among dairy workers in the united states effectiveness of occupational safety and health training for migrant farmworkers: a scoping review nasal colonization of humans with occupational exposure to raw meat and to raw meat products with methicillin-susceptible and methicillin-resistant staphylococcus aureus publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations human and animal rights this article does not contain any studies with human or animal subjects performed by the authors. the authors declare that they have no conflict of interests. papers of particular interest, published recently, have been highlighted as: key: cord- -wawui fd authors: tulchinsky, theodore h.; varavikova, elena a. title: communicable diseases date: - - journal: the new public health doi: . /b - - / - sha: doc_id: cord_uid: wawui fd publisher summary in a world of rapid international transport and contact between populations, systems are needed to monitor the potential explosive spread of pathogens that may be transferred from their normal habitat. the potential for the international spread of new or reinvigorated infectious diseases constitute threat to mankind akin to ecological and other man-made disasters. public health has addressed the issues of communicable disease as one of its key issues in protecting individual and population health. methods of intervention include classic public health through sanitation, immunization, and well beyond that into nutrition, education, case finding, and treatment, and changing human behavior. the knowledge, attitudes, beliefs, and practices of policy makers, health care providers, and parents is as important in the success of communicable disease control as are the technology available and methods of financing health systems. together, these encompass the broad programmatic approach of the new public health to control of communicable diseases. important for all health providers and public health personnel so as to be able to cope with the scale of these problems and to absorb new technologies as they emerge from scientific advances and experience, and their successful application. lived. it was to be observed, indeed, that it did not come straight on toward us; for the city, that is to say within the walls, was indifferently healthy still; nor was it got over the water into southwark; for though there died that week , of all distempers, whereof it might be supposed above died of the plague, yet there was but in southwark, lambeth parish included; whereas in the parishes of st. giles the agent-host-environment triad, discussed in chapter , is fundamental to the success of understanding transmission of infectious diseases and their control, including those well known, those changing their patterns, and those newly emerging or escaping current methods of control. infection occurs when the organism successfully invades the host body, where it multiplies and produces an illness. a host is a person or other living animal, including birds and arthropods, who provides a place for growth and sustenance to an infectious agent under natural, as opposed to experimental, conditions. some organisms, such as protozoa or helminths, may pass successive stages of their life cycle in different hosts, but the primary or definitive host is the one in which the organism passes its sexual stage. the secondary or intermediate host is where the parasite passes the larval or asexual stage. a transport host is a carrier in which the organism remains alive, but does not develop. an agent of an infectious disease is necessary, but not always sufficient to cause a disease or disorder. the infective dose is the quantity of the organism needed to cause clinical disease. a disease may have a single agent as a cause, or it may occur as a result of the agent in company with contributory factors, whose presence is also essential for the development of the disease. a disease may be present in an infected person in a dormant form such as tuberculosis, or a subclinical form, such as poliomyelitis or hiv. the virulence or pathogenicity of an infective agent is the capacity of an infectious agent to enter the host, replicate, damage tissue, and cause disease in an exposed and susceptible host. virulence is indicated by the severity of clinical disease and case fatality rates. the environment provides a reservoir for the organism, and the mode of transmission, by which the organism reaches a new host. the reservoir is the natural habitat where an infectious agent lives and multiplies, from which it can be transmitted directly or indirectly to a new host. the reservoir refers to the natural habitat of the organism, which may be in people, animals, arthropods, plants, soil, or substances in which an organism normally lives and multiplies, and on which it depends for survival or in which it survives in a dormant form. contacts are persons or animals who have been in association with an infected person, animal, or contaminated inanimate object, or environment that might provide an opportunity for acquiring the infective agent. persons or animals that harbor a specific infectious agent, often in the absence of discernible clinical disease, and who serve as a source of infection or contamination of food, water, or other materials, are carriers. a carrier may have an inapparent infection (a healthy cartier) or may be in the incubation or convalescent stage of the infection. communicable diseases may be classified by a variety of methods: by organism, by mode of transmission, by methods of prevention (e.g., vaccine preventable, vector controllable), or by major organism classification, that is, viral, bacterial, and parasitic disease. a virus is a nucleic acid molecule (rna or dna) encapsulated in a protein coat or capsid. the virus is not a complete cell and can only replicate inside a complete cell. the capsid may have a protective envelope of a lipid containing membrane. the capsid and membrane facilitate attachment and penetration of a host cell. inside the host cell, the nucleic molecule may cause the cell's chromosomes to be changed in its own genetic material or so that there is cellular manufacture and virus replication. viroids are smaller rna structures without capsids which can cause plant disease. prions are recently discovered (stanley prusiner, nobel prize, ) variants of viruses or viroids which are the infective agents cause of scrapie in sheep, and similar degenerative central nervous system diseases in cattle and in man (mad cow disease or creutzfeld-jakob disease in humans). bacteria are unicellular organisms that reproduce sexually or asexually, grow on cell-free media, and can exist in an environment with oxygen (aerobic) or in one lacking oxygen (anaerobic). some may enter a dormant state and form spores where they are protected from the environment and may remain viable for years. bacteria include a nucleus of chromosomal dna material within a membrane surrounded by cytoplasm, itself enclosed by the cellular membrane. bacteria are often characterized by their coloration under gram's stain, as gram-negative or gram-positive, as well as by their microscopic morphology, colony patterns on growth media, by the diseases they may cause, as well as by antibody and molecular (dna) marking techniques. bacteria include both indigenous flora (normal resident) bacteria and pathogenic (disease causing) bacteria. pathogenic bacteria cause disease by invading, overcoming natural or acquired resistance, and multiplying in the body. bacteria may produce a toxin or poison that can affect a body site distant from where the bacterial replication occurs, such as in tetanus. bacteria may also initiate an excessive immune response, producing damage to other body tissues away from the site of infection, e.g;, acute rheumatic fever and glomerulonephritis. parasitology studies protozoa, helminths, and arthropods that live within, on, or at the expense of a host. these include oxygen-producing, flagellate, unicellular organisms such as giardia and trichomonas, and amoebas such as entamoeba important in enteric and gynecologic disorders. sporozoa are parasites with complex life cycles in different hosts, such as cryptosporidium or malarial parasites. parasitic disease usually refers to infestation, with fungi, molds, and yeasts that can affect humans. helminths are worms that infest humans especially in poor sanitation and tropical areas. transmission of diseases is by the spread of an infectious agent from a source or reservoir to a person (table . ). direct transmission from one host to another occurs during touching, biting, kissing, sexual intercourse, and projection via droplets, as in sneezing, coughing, or spitting, or by entry through the skin. indirect transmission includes via aerosols of long-lasting suspended particles in air, fecal-oral transmission such as food and waterborne as well as by poor hygenic conditions with inanimate materials, such as soiled clothes, handkerchiefs, toys, or other objects. vector-borne diseases are transmitted via crawling or flying insects, in some cases with multiplication, and development of the organism in the vector, as in malaria. the subsequent transmission to humans is by injection of salivary gland fluid during biting, e.g., congenital syphilis, or by deposition of feces, urine or other material capable of penetrating the skin through a bite wound or other trauma. transmission may occur with insects as a transport mechanism, as in salmonella on the legs of a housefly. airborne transmission occurs inderectly via infective organisms in small aerosols that may remain suspended for long periods of time and which easily enter the respiratory tract. small particles of dust may spread organisms from soil, clothing, or bedding. vertical transmission occurs from one generation to another, or from one stage of the insect life cycle to another stage. maternal-infant transmission occurs during pregnancy (transplacental), delivery, as in gonorrhoea, breast-feeding, e.g., hiv, with transfer of infectious agents from mother to fetus or newborn. resistance to infectious diseases is related to many host and environmental factors, including age, sex, pregnancy, nutrition, trauma, fatigue, living and socioeconomic conditions, and emotional status. good nutritional status has a protective effect against the results of an infection. vitamin a supplements reduce complication rates of measles and enteric infections. tuberculosis may be present in an individual whose resistance is sufficient to prevent clinical disease, but the infected person is a cartier of an organism which can be transmitted to another or cause clinical disease if the person's susceptibility is reduced. immunity is resistance to infection resulting from presence of antibodies or cells that specifically act on the microorganism associated with a specific disease or toxin. immunity to a specific organism can be acquired by having the disease, that is, natural immunity, or by immunization, active or passive, or by protection box . vaccines and prevention "the greeks had two gods of health, aesculapius and hygeia, therapy and prevention, respectively. medicine in the twentieth century retains those two concepts, and vaccination is a powerful means of prevention. what follows is information on the vaccines that together with sanitation, make modem society possible, and that if wisely used will continue to bestow on mankind the gift of prevention, which according to proverb is worth far more than cure." source: plotkin, s. a., mortimer, e. a. . vaccines. second edition. philadelphia: wb saunders (with permission). infectious agent: a pathogenic organism (e.g., virus, bacteria, rickettsia, fungus, protozoa, or helminth) capable of producing infection or an infectious disease. infection: the process of entry, development, and proliferation of an infectious agent in the body tissue of a living organism (human, animal, or plant) overcoming body defense mechanisms, resulting in an inapparent or clinically manifest disease. antigen: a substance (e.g., protein, polysaccharide) capable of inducing specific response mechanisms in the body. an antigen may be introduced into the body by invasion of an infectious agent, by immunization, inhalation, ingestion, or through the skin, wounds, or via transplantation. antibody: a protein molecule formed by the body in response to a foreign substance (an antigen) or acquired by passive transfer. antibodies bind to the specific antigen that elicits its production, causing the infective agent to be susceptible to immune defense mechanisms against infections e.g., humoral and cellular. immunoglobulins: antibodies that meet different types of antigenic challenges. they are present in blood or other body fluids, and can cross from a mother to fetus in utero, providing protection during part of the first year of life. there are five major classes (igg, igm, iga, igd, and ige) and subclasses based on molecular weight. anfisera or antitoxin: materials prepared in animals for use in passive immunization against infection or toxins. source: jawetz, melrick, and adelberg, medical microbiology, . through elimination of circulation of the organism in the community. immunity may be by antibodies produced by the host body or transferred from externally produced antibodies. the body also reacts to infective antigens by cellular responses, including those that directly defend against invading organisms and other cells which produce antibodies. the immune response is the resistance of a body to specific infectious organisms or their toxins provided by a complex interaction of antibodies and cells including a. b cells (bone marrow and spleen) produce antibodies which circulate in the blood, i.e., humoral immunity; b. t cell-mediated immunity is provided by sensitization of lymphocytes of thymus origin to mature into cytotoxic cells capable of destroying virusinfected or foreign cells; c. complement, a humoral response which causes lysis of foreign cells; d. phagocytosis, a cellular mechanism which ingests foreign microorganisms (macrophages and leukocytes). surveillance of disease is the continuous scrutiny of all aspects of occurrence and spread of disease pertinent to effective control of that disease. maintaining ongoing surveillance is one of the basic duties of a public health system, and is vital to the control of communicable disease, providing the essential data for tracking of disease, planning interventions, and responding to future disease challenges. surveillance of infectious disease incidence relies on reports of notifiable diseases by physicians, supplemented by individual and summary reports of public health laboratories. such a system must concern itself with the completeness and quality of reporting and potential errors and artifacts. quality is maintained by seeking clinical and laboratory support to confirm first reports. completeness, rapidity, and quality of reporting by physicians and laboratories should be emphasized in undergraduate and postgraduate medical education. enforcement of legal sanctions may be needed where standards are not met. surveillance of infectious diseases includes the following: . morbidity reports from clinics to public health offices; . mortality reports from attending doctors to vital records; . reports from selected sentinel centers; . special field investigations of epidemics or individual cases; . laboratory monitoring of infectious agents in population samples; . data on supply, use, and side effects of vaccines, toxoids, immune globulins; . data on vector control activities such as insecticides use; . immunity levels in samples of the population at risk; . review of current literature on the disease; . epidemiologic and clinical reports from other jurisdictions. epidemiologic monitoring based on individual and aggregated reports of infectious diseases provide data vital to planning interventions at the community level or for the individually exposed patient and his contacts, along with other information sources such as hospital discharge data and monitoring of sentinel centers. these may be specific medical or community sites that are representative of the population and are able to provide good levels of reporting to monitor an area or population group. a sentinel center can be a pediatric practice site, a hospital emergency room, or other location which will provide a "finger on the pulse" to assess the degree and kind of morbidity occurring in the community. it can also include monitoring in a location previously known for disease transmission, such as hong kong in relation to influenza. epidemiologic analysis provided by government public health agencies should be published weekly, monthly, and annually and distributed to a wide audience of public health and health-related professionals throughout the country. feedback to those in the field on whose initial reports the data are based is vital in order to promote involvement and improved quality of data, as well as to allow evaluation of the local situation in comparison to other areas. in a federal system of government, national agencies report regularly on all state or provincial health patterns. state or provincial health authorities provide data to the counties and cities in their jurisdictions. such data should also be readily available to researchers in other government agencies, universities, and other academic settings for further research and analysis both on internet and hard-copy publications. notifiable diseases are those which a physician is legally required to report to state or local public health officials, by reason of their contagiousness, severity, frequency, or other public health importance (table . ). public health laboratory services provide validation of clinical and epidemiologic reports. they also pro- vide day-to-day supervision of public health conditions, and can monitor communicable disease and vaccine efficacy and coverage. in addition, they support standards of clinical laboratories in biochemistry, microbiology, and genetic screening. nosocomial or hospital-acquired infections constitute a major health hazard associated with care in institutions. in the united states, they occur in - % of hospital admissions and are the cause of lengthening of hospital stay and an estimated , deaths per year. in developing countries, nosocomial infection rates may occur in up to % of hospitalizations. this category of infectious disease most commonly includes infections of the urinary tract, surgical wounds, lower respiratory tract (pneumonias), and blood poisoning or septicemias. in the united states, up to % of hospital-acquired infections are caused by multidrug resistant organisms. staphylococcus infections resistant to many current antibiotics, for example, methicillin and vancomycin, are a notable cause of prolongation of hospitalization or even death. the increasing number of immunodeficient patients has increased the importance of prevention of nosocomial infections. where standards of infection control are lacking, in both developed and developing countries, hospital staff are vulnerable to serious infection. in developing countries, deadly new viruses, such as ebola and marburg viruses mainly affect nursing, medical, and other staff as secondary cases. surveillance and control measures are important elements of hospital management. hospital epidemiologists and infection control staff are part of modem hospital staffing. the cost to the health system of nosocomial infections is a major consideration in planning health budgets. reducing the risk of acquiring such infections in hospital justifies substantial expenditures for hospital epidemiology and infection control activities. with diagnostic related group payment for hospital care (by diagnosis rather than by days of stay) the good manager has a major incentive to ensure that the risk of nosocomial infections is minimized, since they can greatly prolong hospital stays, raising patient dissatisfaction and health care costs. an endemic disease is the constant usual presence of a disease or infectious agent in a given geographic area or population group. hyperendemic is a state of persistence of high levels of incidence of the disease. holoendemic means that the disease appears early in life and affects most of the population, as in malaria or hepatitis a and b in some regions. an epidemic is the occurrence in a community or region of a number of cases of an illness in excess of the usual or expected number of cases. the number of cases constituting an epidemic varies with the disease, and factors such as previous epidemiological patterns of the disease, time and place of the occurrence, and the population involved must be taken into account. a single case of a disease long absent from an area, such as polio, constitutes an epidemic, and therefore a public health emergency because a clinical case may represent a hundred carriers with nonparalytic or subclinical poliomyelitis. in the s, two to three or more cases of measles linked in time and place may be considered sufficient evidence of transmission and presumed to be an epidemic. a pandemic is occurrence of a disease over a very wide area, crossing international boundaries, affecting a large proportion of the population. each epidemic should be regarded as a unique natural experiment. the investigation of an epidemic requires preparation and field investigation in conjunction with local health and other relevant authorities. verification of cases and the scope of the epidemic will require case definition and laboratory confirmation. tabulation of known cases according to time, place, and person are important for immediate control measures and formulation of the hypothesis as to the nature of the epidemic. an epidemic curve is a graphic plotting of the distribution of cases by the time of onset or reporting, which gives a picture of the timing, spread, and extent of the disease from the time of the initial index cases and the secondary spread. epidemic investigation requires a series of steps. this starts with confirmation of the initial report and preliminary investigation, defining who is affected, determining the nature of the illness and confirming the clinical diagnosis, and recording when and where the first (index) and follow-up (secondary) cases occurred, and how the disease was transmitted. samples are taken from index case patients (e.g., blood, feces, throat swabs) as well as from possible vectors (e.g., food, water, sewage, environment). a working hypothesis is established based on the first findings, taking into account all plausible explanations. the epidemic pattern is studied, establishing common source or risk factors, such as food, water, contact, environment, and drawing a time line of cases to define the epidemic curve. how many are ill (the numerator) and what is the population at risk (the denominator) establish the attack rate, namely, the percentage of sick among those exposed to the common factor. what is a reasonable explanation of the occurrence; is there a previous pattern, with the present episode a recurrence or new event? consultation with colleagues and the literature helps to establish both a biological and epidemiologic plausibility. what steps are needed to prevent spread and recurrence of the disease? coordination with relevant health and other officials and providers is required to establish surveillance and control systems, document and distribute reports, and respond to the public's fight to know. the first reports of excess cases may come from a medical clinic or hospital. the initial (sentinel or index) cases provide the first clues that may point to a common source. investigation of an epidemic is designed to quickly elucidate the cause and points of potential intervention to stop its continuation. this requires skilled investigation and interpretation. epidemiologic investigations have defined many public health problems. rubella syndrome, legionnaire's disease, aids, and lyme and hantavirus diseases were first identified clinically when unusually large numbers of cases appeared with common features. the suspicions that were raised led to a search for causes and the identification of control methods. a working hypothesis of the nature of an epidemic is developed based on the initial assessment, the type of presentation, the condition involved, and previous local, regional, national, and international experience. the hypothesis provides the basis for further investigation, control measures, and planning additional clinical and laboratory studies. surveillance will then monitor the effectiveness of control measures. communication of findings to local, regional, national, and international health reporting systems is important for sharing the knowledge with other potential support groups or other areas where similar epidemics may occur. the centers for disease control and prevention (cdc), originally organized in as the office for malaria control in war areas, is part of the u.s. public health service. as of , the cdc had a budget of $ . billion, and employees include epidemiologists, microbiologists, and many other professionals. the cdc includes national centers for environmental health and injury control, chronic disease prevention and health promotion, infectious diseases, prevention services, health statistics, occupational safety and health, and international health. the epidemic intelligence service (eis) of the cdc in the united states is an excellent model for the organization of the national control of communicable diseases. young clinicians are trained to carry out epidemiologic investigations as part of training to become public health professionals. eis officers are assigned to state health departments, other public health units, and research centers as part of their training, carrying out epidemic investigation and special tasks in disease control. the cdc, in cooperation with the who, has developed and offers free of charge, a personal computer program to support field epidemiology, including epidemic investigations (epi-info), which can be accessed and down-loaded from the worldwide web. this program should be adopted widely in order to improve field investigations, to encourage reporting in real time, and to develop high standards in this discipline. cdc's morbidity and mortality weekly report (mmwr) is a weekly publication of the cdc's epidemiologic data, also available free on the internet. it includes special summaries of reportable infectious diseases as well as noncom- although an infectious disease is an event affecting an individual, it is communicable to others, and therefore its control requires both individual and community measures of protection. control of the disease is a reduction in its incidence, prevalence, morbidity, and mortality. elimination of a disease in a specified geographic area may be achieved as a result of intervention programs such as individual protection against tetanus; elimination of infections such as measles requires stoppage of circulation of the organism. eradication is success in reduction to zero of incidence of the disease and presence in nature of the organism, such as with smallpox. extinction means that a specific organism no longer exists in nature or in laboratories. public health applies a wide variety of tools for the prevention of infectious diseases and their transmission. it includes activities ranging from filtration and disinfection of community drinking water to environmental vector control, pasteurization of milk, and immunization programs (see table . ). no less important are organized programs to promote self protection, case finding, and effective treatment of infections to stop their spread to other susceptible persons (e.g., hiv, sexually transmitted diseases, tuberculosis, malaria). planning measures to control and eradicate specific communicable diseases is one of the principal activities of public health and remains so for the twenty-first century. treating an infection once it has occurred is vital to the control of a communicable disease. each person infected may become a vector and continue the chain of transmission. successful treatment of the infected person reduces the potential for an uninfected contact person to acquire the infection. bacteriostatic agents or drugs such as sulfonamides inhibit growth or stop replication of the organism, allowing normal body defenses to overcome the organism. bacteriocidal drugs such as penicillin act to kill pathogenic organisms. traditional medical emphasis on single antibiotics has changed to use of multiple drug combinations for tuberculosis and more recently for hospital-acquired infections. antibiotics have made enormous contributions to clinical medicine and public health. however, pathogenic organisms are able to adapt or mutate and develop resistance to antibiotics, resulting in drug resistance. wide-scale use of antibiotics has led to increasing incidence of resistant organisms. multidrug resistance constitutes one of the major public health challenges at the end of the twentieth century. antiviral agents (e.g., ribovarin) are important additions to medical treatment potential, as are "cocktails" of antiviral agents for management of hiv infection. antibiotic use is a health problem requiting attention of clinicians and their teachers as well as the public health community and health care managers, representing the interaction of health issues across the entire spectrum of services. organized public health services are responsible for advocating legislation and for regulating and monitoring programs to prevent infectious disease occurrence and/or spread. they function to educate the population in measures to reduce or prevent the spread of disease. health promotion is one of the most essential instruments of infectious disease control. it promotes compliance and community support of preventive measures. these include personal hygiene and safe handling of water, milk, and food supplies. in sexually transmitted diseases, health education is the major method of prevention. each of the infectious diseases or groups of infectious diseases have one or more preventive or control approaches (table . ). these may involve the coordinated intervention of different disciplines and modalities, including epidemiologic monitoring, laboratory confirmation, environmental measures, immunization, and health education. this requires teamwork and organized collaboration. very great progress has been made in infectious disease control by clinical, public health, and societal means since in the industrialized countries and since the s in the developing world. this is attributable to a variety of factors, including organized public health services; the rapid development and wide use of new and improved vaccines and antibiotics; better access to health care; and improved sanitation, living conditions, and nutrition. triumphs have been achieved in the eradication of smallpox and in the increasing control of other vaccine-preventable diseases. however, there remain serious problems with tb, stds, malaria, and new infections such as hiv, and an increase in multiple drug-resistant organisms. vaccines are one of the most important tools of public health in the control of infectious diseases, especially for child health. vaccine-preventable diseases ta b l e . annual incidence of selected vaccine-preventable infectious diseases in rates per , population selected years, united states, - disease the body responds to invasion of disease-causing organisms by antigenantibody reactions and cellular responses. together, these act to restrain or destroy the disease-causing potential. strengthening this defense mechanism through im-box . definitions of immunizing agents and processes vaccines: a suspension of live or killed microorganisms or antigenic portion of those agents presented to a potential host to induce immunity to prevent the specific disease caused by that organism. preparation of vaccines may be from: a. live attenuated organisms which have been passed repeatedly in tissue culture or chick embryos so that they have lost their capacity to cause disease but retain an ability to induce antibody response, such as polio-sabin, measles, rubella, mumps, yellow fever, bcg, typhoid, and plague. b. inactivated or killed organisms which have been killed by heat or chemicals but retain an ability to induce antibody response; they are generally safe but less efficacious than live vaccines and require multiple doses, such as polio-salk, influenza, rabies, and japanese encephalitis. c. cellular fractions usually of a polysaccharide fraction of the cell wall of a disease-causing organisms, such as pneumococcal pneumonia or meningococcal meningitis. d. recombinant vaccines produced by recombinant dna methods in which specific dna sequences are inserted by molecular engineering techniques, such as dna sequences spliced to vaccinia virus grown in cell culture to produce influenza and hepatitis b vaccines. toxoids or antisera: modified toxins are made nontoxic to stimulate formation of an antitoxin, such as tetanus, diphtheria, botulism, gas gangrene, and snake and scorpion venom. immune globulin: an antibody-containing solution derived from immunized animals or human blood plasma, used primarily for short-term passive immunization, e.g., rabies, for immunocompromised persons. antitoxin: an antibody derived from serum of animals after stimulation with specific antigens and used to provide passive immunity, e.g., tetanus. munization is one of the outstanding achievements of public health, as treatment of infectious diseases by antimicrobials is a major element of clinical medicine. immunization (vaccination) is a process used to increase host resistance to specific microorganisms to prevent them from causing disease. it induces primary and secondary responses in the human or animal body: a. primary response occurs on first exposure to an antigen. after a lag or latent period of - days (depending on the antigen) specific antibodies appear in the blood. antibody production ceases after several weeks but memory cells that can recognize the antigen and respond to it remain ready to respond to a further challenge by the same antigen. b. secondary (booster) response is the response to a second and subsequent exposure to an antigen. the lag period is shorter than the primary response, the peak is higher and lasts longer. the antibodies produced have a higher affinity for the antigen, and a much smaller dose of the antigen is required to initiate a response. c. immunologic memory exists even when circulating antibodies are insufficient to protect against the antigen. when the body is exposed to the same antigen again, it responds by rapidly producing high levels of antibody to destroy the antigen before it can replicate and cause disease. immunization protects susceptible individuals from communicable disease by administration of a living modified agent, or subunit of the agent, a suspension of killed organisms or an inactivated toxin (see table . ) to stimulate development of antibodies to that agent. in disease control, individual immunity may also protect another individual. herd immunity occurs when sufficient persons are protected (naturally or by immunization) against a specific infectious disease reducing circulation of the organism, thereby lowering the chance of an unprotected person to become infected. each pathogen has different characteristics of infectivity, and therefore different levels of herd immunity are required to protect the nonimmune individual. the critical proportion of a population that must be immunized in order to interrupt local circulation of the organism varies from disease to disease. eradication of smallpox was achieved with approximately % world coverage, followed by concentration on new case findings and immunization of contacts and surrounding communities. for highly infectious diseases, such as measles, immunization coverage of over % is needed to achieve local eradication. immunization coverage in a community must be monitored in order to gauge the extent of protection and need for program modification to achieve targets of disease control. immunization coverage is expressed as a proportion in which the numerator is the number of persons in the target group immunized at a specific age, and the denominator is the number of persons in the target cohort who should have been immunized according to the accepted standard: vaccine coverage = no. persons immunized in specific age group • no. persons in the age group during that year immunization coverage in the united states is regularly monitered by the national immunization survey by a household survey in all states, as well as selected urban areas considered to be at high risk for undervaccination. an initial telephone survey is followed by confirmation, where possible, from documentation from the parents or health care providers. the survey for july -june examined children born between august and november (i.e., aged - months, median age months). the results show improving coverage, with % having received three or more doses of dpt (diphtheria, pertussis, and tetanus), % with three or more doses of opv (oral polio vaccine), % with three or more doses of haemophilus influenzae, type b (hib), but only % with three or more doses of hepatitis b. however, only % had received all recommended vaccines at the recommended ages. eases that still cause millions of deaths globally each year. other important infectious diseases are still not subject to vaccine control because of difficulties in their development. in some cases, a microorganism can mutate with changes. viruses can undergo antigenic shifts in the molecular structure in the organism, producing completely new subtypes of the organism. hosts previously exposed to other strains may have little or no immunity to the new strains. antigenic drift refers to relatively minor antigenic changes which occur in viruses. this is responsible for frequent epidemics. antigenic shift is believed to explain the occurrence of new strains of influenza virus necessitating, for example, annual reformulation of the influenza vaccine associated with large scale epidemics and pandemics. new variants of poliovirus strains are similar enough to the three main types so that immunity to one strain is carded over to the new strain. molecular epidemiology is a powerful new technique used to specify the geographic origin of organisms such as poliomyelitis and measles viruses, permiting tracking of the source of the virus and epidemic. combinations of more than one vaccine is now common practice with a trend to enlarging the cocktail of vaccines in order to minimize the number of injections, and visits required. this reduces the number of visits to carry out routine immunization saving staff time and costs, as well as increasing compliance. there are virtually no contraindications to use of multiple antigens simultaneously. examples of vaccine cocktails include dpt (diphtheria, pertussis, and tetanus) in combination with haemophilus influenzae b, poliomyelitis, and varicella, or mmr (measles, mumps, and rubella) vaccines. interventions in the form of effective vaccines save millions of lives each year and contribute to improved health of countless children and adults throughout the world. vaccination is now accepted as one of the most cost-effective health interventions currently available. continuous policy review is needed regarding allocation of adequate resources, logistical organization, and continued scientific effort to seek effective, safe, and inexpensive vaccines for other important diseases such as malaria and hiv. new technology of recombinant vaccines, such as that of hepatitis b, holds promise for important vaccine breakthroughs in the decades ahead. internationally, much progress was made in the s in the control of vaccinepreventable diseases. at the end of the s, fewer than % of the world's children were being immunized. who, unicef, and other international organizations mobilized to promote an expanded programme on immunization (epi) with a target of reaching % coverage by . immunization coverage increased in the developing countries, preventing some million child deaths annually. bacillus calmette-gu rin (bcg) coverage rose from to %; poliomyelitis with opv (three doses) from to %, and tetanus toxoid for pregnant women from to %. since , there has been a decline in coverage in some parts of the world, mainly in sub-saharan africa. the challenge remains to achieve control or eradication of vaccine-preventable diseases, thus saving millions of more lives. part of the hfa stresses the epi approach, which includes immunization against diphtheria, pertussis, tetanus, po-liomyelitis, measles, and tuberculosis. an extended form of this is the epi plus program which combines epi with immunization against hepatitis b and yellow fever and, where appropriate, supplementation with vitamin a and iodine. the success in international eradication of smallpox is now being followed by a campaign to eradicate poliomyelitis and other important infectious diseases. diphtheria. diphtheria is an acute bacterial disease of the tonsils, nasopharynx, and larynx caused by the organism corynebacterium diphtheriae. it occurs in colder months in temperate climates where the organism is present in human hosts and is spread by contact with patients or carriers. it has an incubation period of - days. in the past, this was primarily an infection of children and was a major contributor to child mortality in the prevaccine and preantibiotic eras. diphtheria has been virtually eliminated in countries with well-established immunization programs. in the s, an outbreak of diphtheria occurred in the countries of the former soviet union among people over age . it reached epidemic proportions in the s, with , cases ( - ) with deaths in in russia alone. this indicates a failure of the vaccination program in several respects: it used only three doses of dpt in infancy; no boosters were given at school age or subsequently; the efficacy of diphtheria vaccine may have been low, and coverage was below %. efforts to control the present epidemic include mass vaccination campaigns for persons over years of age with a single dose of dt (diphtheria and tetanus) and increasing coverage of routine dpt vaccines to four doses by age years. the epidemic and its control measures have led to improved coverage with dt for those over years, and % coverage among children aged - months. who recommends three doses of dpt in the first year of life and a booster at school entry. this is considered by many to be insufficient to produce long-lasting immunity. the united states and other industrialized countries use a four-dose schedule and recommend periodic boosters for adults with dt. pertussis. pertussis is an acute bacterial disease of the respiratory tract caused by the bacillus bordetella pertussis. after an initial coldlike (catarrhal) stage, the patient develops a severe cough which comes in spasms (paroxysms). the disease can last - months. the paroxysms can become violent and may be followed by a characteristic crowing or high pitched inspiratory whooping sound, followed by expulsion of a tenacious clear sputum, often followed by vomiting. in poorly immunized populations and those with malnutrition, pneumonia often follows and death is common. pertussis declined dramatically in the industrialized countries as a result of widespread coverage with dpt. however, because the pertussis component of the vaccine caused some reactions, many physicians avoided its use, using dt alone. during the s in the united kingdom, many physicians recommended against vaccination with dpt. as a result, pertussis incidence increased with substantial mortality rates. this led to a reappraisal of the immunization program, with insti-tution of incentive payments to general practitioners for completion of vaccination schedules. as a result of these measures, vaccination coverage, with resulting pertussis control, improved dramatically in the united kingdom. pertussis continues to be a public health threat and recurs wherever there is inadequate immunization in infancy. a new acellular vaccine is ready for widespread use and will be safer with fewer and less severe reactions in infants, increasing the potential for improved confidence and support for routine vaccination. use of the new vaccine is spreading in the united states and forms part of the u.s. recommended vaccination schedule. tetanus. tetanus is an acute disease caused by an exotoxin of the tetanus bacillus (clostridium tetani) which grows anaerobically at the site of an injury. the bacillus is universally present in the environment and enters the human body via penetrating injuries. following an incubation period of - days, it causes an acute condition of painful muscular contractions. unless there is modem medical care available, patients are at risk of high case fatality rates of - % (highest in infants and the elderly). antitetanus serum (ats) was discovered in and during world war i, ats contributed to saving the lives of many thousands of wounded soldiers. tetanus toxoid was developed in . the organism, because of its universal presence in the environment, cannot be eradicated. however, the disease can be controlled by effective immunization of every child during infancy and school age. adults should receive routine boosters of tetanus toxoid once very decade. newborns are infected by tetanus spores (tetanus neonatorum) where unsanitary conditions or practices are present. it can occur when traditional birth attendants at home deliveries use unclean instruments to sever the umbilical cord, or dress the severed cord with contaminated material. tetanus neonatorum remains a serious public health problem in developing countries. immunization of pregnant women and women of childbearing age is reducing the problem by conferring passive immunity to the newborn. the training of traditional birth attendants in hygienic practice and the use of medically supervised birth centers for delivery also decreases the incidence of tetanus neonastorum. elimination of tetanus neonatorum by the year was made a health target by the world summit of children in . in that year, the number of deaths from neonatal tetanus was reported by unicef as , infants worldwide, declining to , in . immunization of pregnant women increased from under % in to % in - . despite progress, coverage is still too low to achieve the target of elimination. poliomyelitis. polio virus infection may be asymptomatic or cause an acute nonspecific febrile illness. it may reach more severe forms of aseptic meningitis and acute flaccid paralysis with long-term residual paralysis or death during the acute phase. poliomyelitis is transmitted mainly by direct person-to-person contact, but also via sewage contamination. large-scale epidemics of disease, with attendant paralysis and death, occurred in industrialized countries in the s and s, engendering widespread fear and panic and thousands of clinical cases of "infantile paralysis". growth of the poliovirus by john enders and colleagues in tissue culture in led to development of the first inactivated polio vaccine by jonas salk in the mid- s and gave hope and considerable success in the control of the disease. the development of the live attenuated oral poliomyelitis vaccine by albert sabin, licensed in , added a new dimension to its control because of the effectiveness, low cost, and ease of administration of the vaccine. the two vaccines in their more modern forms, enhanced strength inactivated polio vaccine (eipv), and triple oral polio vaccine (topv), have been used in different settings with great success. oral polio vaccine (opv) induces both humoral and cellular, including intestinal, immunity. the presence of opv in the environment by contact with immunized infants and via excreta of immunized persons in the sewage gives a booster effect in the community. immunization using opv, in both routine and national immunization days (nids) has proven effective in dramatically reducing poliomyelitis and circulation of the wild virus in many parts of the world. use of the enhanced strength ipv (eipv) produces early and high levels of circulating antibodies, as well as protecting against the vaccine-associated disease. in rare cases opv can cause vaccine-associated paralytic poliomyelitis (vapp), with a risk of case per , with initial doses, and case per over million with subsequent doses. approximately eight to ten cases of vapp occur annually in the united states, with clinical, ethical, and legal implications. use of ipv as initial protection eliminates this problem. experience in gaza and the west bank in the s and s, and later in israel, showed that a combination of ipv and opv is effective in overcoming endemic and imported poliovirus. opv requires multiple doses to achieve protective antibody levels. where there are many enteroviruses in the environment, as is the case in most developing countries, interference in the uptake of opv may result in cases of paralytic poliomeylitis among persons who have received or even doses of adequate opv. controversy as to the relative advantages of each vaccine continues. the opv program of mass repeated vaccination in control of poliomyelitis in the americas established the primacy of opv in practical public health, and the momentum to eradicate poliomyelitis is building. a combined schedule of ipv and opv would eliminate the wild virus and protect against vaccine-associated disease. the sequential use of ipv and opv was adopted as part of the routine infant immunization program in the united states in , but ipv alone was adopted in . there are concerns that exclusive use of either vaccine alone will not lead to the desired goal of eradication of polyomyelitis. progress in global eradication of polio has been impressive. global coverage of infants with three doses of opv reached % in as compared to % in . the african region of who had an increase in opv coverage from % in to % in . national immunization days (nids) were conducted in countries in and in , covering million children in . mopping up operations to reinforce coverage of children in still endemic areas is proceeding along with increased emphasis on acute flaccid paralysis (afp) monitoring. confirmed polio cases reported continued at - , per year in - . with continued national and international emphasis, and support of who, rotary international, unicef, donor countries, and others, there is a real prospect of a world without polio, if not by the year , then or shortly thereafter. measles is an acute disease caused by a virus of the paramyxovirus family. it is highly infectious with a very high ratio of clinical to subclinical case ratio ( / ). measles has a characteristic clinical presentation with fever, white spots (koplik spots) on the membranes of the mouth, and a red blotchy rash appearing on the rd- th day lasting - days. mortality rates are high in young children with compromised nutritional status, especially vitamin a deficiency. the measles virus evolved from a virus disease of cattle (rinderpest) some - years ago, becoming an important disease of humans with high mortality rates in debilitated, poorly nourished children, and significant mortality and morbidity even in industrialized countries. in the prevaccine era, measles was endemic worldwide, and even in the late s it remains one of the major childhood infectious diseases. it is one of the commonest causes of death for school age children worldwide. despite earlier predictions that measles deaths would be halved to , by , who reported . million measles deaths in that year and over million in . eradication in the first decade of the next century is a feasible goal, provided that there is an adequate international effort. measles immunization increased from under % worldwide in to % in - , but % in sub-saharan africa. single-dose immunization failed to meet control or eradication requirements even in the most developed parts of the world. a live vaccine, licensed in , was later replace by a more effective and heat stable vaccine, but still with a primary vaccination failure rate (i.e., fails to produce protective antibodies) of - %, and secondary failure rate (i.e., produces antibodies but protection is lost over time) of %. a two-dose policy incorporates a booster dose, usually at school-age, in addition to maximum feasible infant coverage of children in the - month period (timing varies in different countries). catch-up campaigns among schoolage children should be carried out until the routine two-dose policy has time to take full effect. nearly universal primary education in developing countries, offers an opportunity for mass coverage of school age children with a second dose of measles and a resulting increase of herd immunity to reduce the transmission of the virus. the two-dose policy adopted in many countries, should be supplemented with catch-up campaigns in schools to provide the booster effect for those previously immunized and to cover those previously unimmunized, especially in developing countries. the cdc considers that domestic transmission in the united states has been interrupted and that most localized outbreaks were traceable to imported cases. south america and the caribbean countries are now considered free of indigenous measles, based on their successful use of nids, although a large epidemic occurred in in brazil. it now appears that eradication has become a feasible target during the early part of the next century, with a strategy of levels of coverage in in-fancy with a two-dose policy, supplemented by catch-up campaigns to older children and young adults, and outbreak control. mumps. mumps is an acute viral disease characterized by fever, swelling, and tenderness usually of the parotid glands, but also other glands. the incubation period ranges between and days. orchitis, or inflammation of the testicles, occurs in - % of postpubertal males and oophoritis, or inflammation of the ovaries, in % of postpubertal females. sterility is an extremely rare result of mumps. central nervous system involvement can occur in the form of aseptic meningitis, almost always without sequelae. encephalitis is reported in - per , cases with an overall case fatality rate of . %. pancreatitis, neuritis, nerve deafness, mastiffs, nephritis, thyroiditis, and pericarditis, although rare, may occur. most persons born before are immune to the disease, because of the nearly universal exposure to the disease before that time. the live attenuated vaccine introduced in the united states in is available as a single vaccine or in combination with measles and rubella as the measlesmumps-rubella (mmr) vaccine. it provides long-lasting immunity in % of cases. mumps vaccine is now recommended in a two-dose policy with the first dose of mmr given between and months of age and a second dose given either at school entry or in early adolescence. mmr in two doses is now standard policy in the united sates, sweden, canada, israel, the united kingdom, and other countries. the incidence of mumps has consequently declined rapidly. local eradication of this disease is worthwhile and should be part of a basic international immunization program. rubella. rubella (german measles) is generally a mild viral disease with lymphadenopathy and a diffuse, raised red rash. low grade fever, malaise, coryza, and lymphadenopathy characterize the prodromal period. the incubation period is usually - days. differentiation from scarlet fever, measles, or other febrile diseases with rash may require laboratory testing and recovery of the virus from nasopharyngeal, blood, stool, and urine specimens. in , norman gregg, an australian ophthalmologist, noted an epidemic of cases of congenital cataract in newborns associated with a history of rubella in the mother during the first trimester. subsequent investigation demonstrated that intrauterine death, spontaneous abortion, and congenital anomalies occur commonly when rubella occurs early in pregnancy. congenital rubella syndrome (crs) occurs with single or multiple congenital anomalies including deafness, cataracts, microophthalmia, congenital glaucoma, microcephaly, meningoencephalitis, congenital heart defects, and others. moderate and severe cases are recognizable at birth, but mild cases may not be detected for months or years after birth. insulin-dependent diabetes is suspected as a late sequela of congenital rubella. each case of crs is estimated to cost some $ , in health care costs during the patient's lifetime. prior to availability of the attenuated live rubella vaccine in , the disease was universally endemic, with epidemics or peak incidence every - years. in unvaccinated populations, rubella is primarily a disease of childhood. in areas where children are well vaccinated, adolescent and young adult infection is more apparent, with epidemics in institutions, colleges, and among military personnel. a sharp reduction of rubella cases was seen in the united states following introduction of the vaccine in , but increased in , following rubella epidemics in - . a further reduction in cases was followed by a sharp upswing of rubella and crs in [ ] [ ] [ ] . an outbreak of rubella among the amish in the united states, who refuse immunization on religious grounds, resulted in cases of crs in . it is now thought that vaccination of sufficient numbers in the united states reduced circulation of the virus and protected most vulnerable groups in the population. in the past, immunization policy in some countries was to vaccinate school girls aged to protect them for the period of fertility. the current approach is to give a routine dose of mmr in early childhood, followed by a second dose in early school age to reduce the pool of susceptible persons. women of reproductive age should be tested to confirm immunity before pregnancy and immunized if not already immune. should a woman become infected during pregnancy, termination of pregnancy previously recommended is now managed with hyperimmune globulin. the infection of pregnant women during their first trimester of pregnancy is the primary public health implication of rubella. the emotional and financial burden of crs, including the cost of treatment of its congenital defects, makes this vaccination program cost-effective. its inclusion in a modem immunization program is fully justified. elimination of crs syndrome should be one of the primary goals of a program for prevention of vaccine-preventable disease in developed and developing countries. adoption of mmr and the two-dose policy will gradually lead to eradication of rubella and rubella syndrome. viral hepatitis. viral hepatitis is a group of diseases of increasing public health importance due to their large scale worldwide prevalence, their serious consequences, and our increasing ability to take preventive action. viral hepatic infectious diseases each have specific etiologic, clinical, epidemiologic, serologic, and pathologic characteristics. they have important short-and long-term sequelae. vaccine development is of high priority for control and ultimate eradication. hepatitis a. hepatitis a (hav) was previously known as infectious hepatitis or epidemic jaundice. hav is mainly transmitted by the fecal-oral route. clinical severity varies from a mild illness of - weeks to a debilitating illness lasting several months. the norm is complete recovery within weeks, but a fulminating or even fatal hepatitis can occur. severity of the disease worsens with increasing age. hav is sporadic/endemic worldwide. improving sanitation raises the age of exposure, with accompanying complications. it now occurs particularly in persons from industrialized countries when exposed to situations of poor hygiene, or among young adults when traveling to areas where the disease is en-demic. common source outbreaks occur in school-aged children and young adults from case contact, or from food contaminated by infected handlers. hepatitis a may be a serious public health problem in a disaster situation. prevention involves improving personal and community hygiene, with safe chlorinated water and proper food handling. hepatitis a vaccine has been recently licensed for use in the united states, and will probably soon be recommended for routine vaccination programs, as well as for persons traveling to endemic areas. hepatitis b. hepatitis b (hbv) once called serum jaundice, was thought to be transmitted only by injections of blood or blood products. it is now known to be present in all body fluids and easily transmissible by household and sexual contact, perinatal spread from mother to newborn, and between toddlers. however, it is not spread by the oral-fecal route. hepatitis b virus is endemic worldwide and is especially prevalent in developing countries. carrier status with persistent viremia varies from < % of adults in north america to % in some parts of the world. carders have detectable levels of hbsag, the surface antigen (i.e., australian antigen), in their blood. high risk groups in developed countries include intravenous drug users, homosexual men, persons with high numbers of sexual partners, those receiving tattoos, body piercing or acupuncture treatments, and residents or staff of institutions such as group homes and prisons. immunocompromised and hemodialysis patients are commonly carders of hbv. hbv may also be spread in a health system by use of inadequately sterilized reusable syringes, as in china and the former soviet union. transmission is reduced by screening blood and blood products for hbsag and strict technique for handling blood and body fluids in health settings. hbv is clinically recognizable in less than % of infected children but is apparent in - % of infected adults. clinically hbv has an insidious onset with anorexia, abdominal discomfort, nausea, vomiting, and jaundice. the disease can vary in severity from subclinical, very mild to fulminating liver necrosis, and death. it is a major cause of primary liver cancer, chronic liver disease, and liver failure, all devastating to health and expensive to treat. hepatitis b virus is considered to be the cause of % of primary cancer of the liver in the world and the most common carcinogen after cigarette smoking. the who estimates that more than billion people alive today have been infected with hbv. it is also estimated that million persons are chronic carriers of hbv, with an estimated - . million deaths per year from cirrhosis or primary liver cancer. this makes hepatitis b control a vital issue in the revision of health priorities in many countries. strict discipline in blood banks and testing of all blood donations for hbv, as well as hiv, and hepatitis c, is mandatory, with destruction of those with positive tests. contacts should be immunized following exposure with hbv immunoglobulin and hbv vaccine. the inexpensive recombinant hbv vaccine should be adopted by all countries and included in routine vaccination of infants. catch-up immunization for older children is also desirable. immunization programs should include those exposed at work, such as health, prison, or sex workers and adults in group settings. hbv immunization has been included in who's epi-plus expanded program of immunization. hepatitis c. first identified in , and previously known as non-a, non-b hepatitis, hepatitis c (hcv) has an insidious onset with jaundice, fatigue, abdominal pain, nausea, and vomiting. it may cause mild to moderate illness, but chronicity is common going on to cirrhosis and liver failure. the cdc estimates that million americans are chronically infected with hcv, with - , resulting deaths per annum, and the main cause of liver transplants. hcv is transmitted most commonly in blood products, but also among injecting drug users ( % of intravenous drug users were hcv positive in a vancouver study in ), and is also a risk for health workers. the disease may also occur in dialysis centers and other medical situations. person-to-person spread is unclear. prevention of transmission includes routine testing of blood donations, antiviral treatment of blood products, needle exchange programs, and hygiene. the who in has declared hepatitis prevention as a major public health crisis, with an estimated million persons infected worldwide ( ) , stressing that this "silent epidemic" is being neglected and that screening of blood products is vital to reduce transmission of this disease as for hiu hcv is a major cause of chronic cirrhosis and liver cancer. no vaccine is available at present, but an experimental vaccine is undergoing field trials. interferon and ribavirin treatment is reportedly effective in % of cases. hepatitis d. hepatitis d virus (hdv) also known as delta hepatitis, may be self-limiting or progress to chronic hepatitis. it is caused by a viruslike particle which infects cells along with hbv as a coinfection or in chronic carriers of hbv. hdv occurs worldwide in the same groups at risk for hbv. it also occurs in epidemics and is endemic in south america, africa, and among drug users. prevention is by measures similar to those for hbv. management for hdv is by passive immunity with immunoglobulin for contacts and high risk groups, and should include hbv vaccination as the diseases often coincide. there is currently no vaccine for hdv. hepatitis e. hepatitis e virus has an epidemiological and clinical course similar to that of hav. there is no evidence of a chronic form of hev. one striking characteristic of hev is its high mortality rate among pregnant women. the disease is caused by a viruslike particle with an incubation period of - days and is most common in young adults. sporadic cases as well as epidemics have been identified in india, pakistan, burma, china, russia, mexico, and north africa. hev results from waterborne epidemics or as sporadic cases in areas with poor hygiene, spread via the oral-fecal route. it is a hazard in disaster situations with crowding and poor sanitary conditions. prevention is by safe management of water supplies and sanitation. disease management is supportive care; passive immunization is not helpful and no vaccine is currently available. teria which causes meningitis and other serious infections in children under months of age. before the introduction of effective vaccines, as many as in children developed invasive hib infection. two-thirds of these had hib meningitis, with a case fatality rate of - %. long-term sequelae such as hearing impairment and neurological deficits occurred in - % of survivors. the first hib vaccine was licensed in , based on capsular material from the bacteria. extensive clinical trials in finland demonstrated a high degree of efficacy, but less impressive results were in seen in postmarketing efficacy studies. by , a conjugate vaccine based on an additional protein cell capsular factor capable of enhancing the immunologic response was introduced. several conjugate vaccines are now available. the conjugate vaccines are now combined with dpt as their schedule is simultaneous with that of the dpt. although the hib vaccine has been found to be cost-effective, despite initially being as costly as all the basic vaccines combined (i.e., dpt, opv, mmr, and hbv). for this reason, its use thus far has been limited to industrialized countries. the vaccine is a valuable addition to the immunologic armamentarium. it showed dramatic results in local eradication of this serious early childhood infection in a number of european countries and a sharp reduction in the united states. impressive field trials in the gambia showed a sharp reduction in mortality from invasive streptococcal diseases. the price of the vaccine has also fallen dramatically since the mid s. as a result, in , the world health organization recommended inclusion of hib vaccine in routine immunization programs in developing countries. influenza. influenza is an acute viral respiratory illness characterized by fever, headache, myalgia, prostration, and cough. transmission is rapid by close contact with infected individuals and by airborne particles with an incubation period of - days. it is generally mild and self-limited with recovery in - days. however, in certain population groups, such as the elderly and chronically ill, infection can lead to severe sequelae. gastrointestinal symptoms commonly occur in children. during epidemics, mortality rates from respiratory diseases increase because of the large numbers of persons affected, although the case fatality rates are generally low. over the past century, influenza pandemics have occurred in , , , and , while epidemics are annual events. the influenza pandemic of caused millions of deaths among young adults, by some estimates killing more than had died in world war i. it was the fear of recurrence of this pandemic which led the cdc to launch a massive immunization program in the united states in to prevent swine flu (the virus was a strain antigenically similar to that of the pandemic influenza) from spreading from an isolated outbreak in an army camp. the effort was stopped after millions of persons were immunized with an urgently produced vaccine when serious reactions occurred (guillain-barre syndrome, (i.e., a type of paralysis), and when no further cases of swine flu were seen. this demonstrated the difficulty of extrapolating scenarios from a historical experience. each year, epidemiologic services of the who and collaborating centers such as the cdc recommend which strains should be used in vaccine preparation for use among susceptible population groups. these vaccines are prepared with the current anticipated epidemic strains. the three main types of influenza (a, b, and c) have different epidemiological characteristics. type a and its subtypes, which are subject to antigenic shift, are associated with widespread epidemics and pandemics. type b undergoes antigenic drift and is associated with less widespread epidemics. influenza type c is even more localized. active immunization against the prevailing wild strain of influenza virus produces a - % level of protection in high risk groups. the benefits of annual immunization outweigh the costs, and it has proven to be effective in reducing cases of influenza and its secondary complications such as pneumonia and death from respiratory complications in high-risk groups. pneumococcal disease. pneumococcal diseases, which are caused by streptococcus pneumoniae, include pneumonia, meningitis, and otitis media. the capsular types of pneumococci selected out of known types of the organism for the vaccine are those responsible for % of pneumococcal pneumonia cases and - % of all pneumonia cases in the united states, and are responsible for some , deaths per year. this vaccine has been found to be cost-effective for high risk groups, including persons with chronic disease, hiv carriers, patients whose spleens were removed, the elderly, and those with immunosuppressive conditions. it should be included in preventive-oriented health programs, especially for long-term care of the chronically ill. because pneumococci cause bacterial meningitis, pneumococcal vaccine may be a future candidate for use in routine immunization programs for children (over age ). varicella is an acute, generalized virus disease caused by the varicella zoster virus (vzv). despite its reputation as an innocuous disease of childhood, varicella patients can be quite ill. a mild fever and characteristic generalized red rash lasts for a few hours, followed by vesicles occurring in successive crops over various areas of the body. affected areas may include the membranes of the eyes, mouth, and respiratory tract. the disease may be so mild as to escape observation or may be quite severe, especially in adults. death can occur from viral pneumonia in adults and sepsis or encephalitis in children. neonates whose mothers develop the disease within days of delivery are at increased risk with a case fatality rate of up to %. long-term sequelae include herpes zoster or shingles with a severely painful, vesicular rash along the distribution of sensory nerves, which can last for months. its occurrence increases with age and it is primarily seen in the elderly. it can, however, occur in immunocompromised children (especially those on cancer chemotherapy), aids patients, and others. some % of a population will experience herpes zoster during their lifetimes. reye's syndrome is an increasingly rare but serious complication from varicella or influenza b. it occurs in children and affects the liver and central nervous system. congenital varicella syndrome with birth defects similar to congenital rubella syndrome has been identified recently. varicella vaccine is now recommended for routine immunization at age - months in the united states, with catch-up for children up to age years and for occupationally exposed persons in health or child care settings. varicella vaccine is also recommended for nonpregnant women of child bearing years. cost-benefit studies indicate a : ratio if both direct and indirect costs are included (see chapter ). varicella vaccine is likely to be added to a "cocktail vaccine" containing dpt, polio (ipv), and hib. meningococcal meningitis. meningococcal meningitis, caused by the bacterium neisseria meningitides, is characterized by headache, fever, neck stiffness, delirium, coma, and/or convulsions. the incubation period is - days. it has a case fatality rate of - % if treated early and adequately, but rises up to % in the absence of treatment. there are several important strains (a, b, c, x, y, and z). serogroups a and c are the main causes of epidemics, with b causing sporadic cases and local outbreaks. transmission is by direct contact and droplet spread. meningitis (group a) is common in sub-saharan african countries, but epidemics have occurred worldwide. during epidemics, children, teenagers, and young adults are the most severely affected. in developed countries, outbreaks occur most frequently in military and student populations. in , meningococcal meningitis spread widely in the "meningitis belt" in central africa. epidemic control is achieved by mass chemoprophylaxis with antibiotics (e.g., rifampin or sulfa drugs) among case contacts, although the emergence of resistant strains is a concern. vaccines against serotypes a and c (bivalent) or a, c, w, and y are available. their use is effective in epidemic control and prevention institutions and military recruits, especially for a and c serogroups. vaccination is one of the key modalities of primary prevention. immunization is cost-effective and prevents wide-scale disease and death, with high levels of safety. despite the general consensus in public health regarding the central role of vaccination, there are many areas of controversy and unfulfilled expectations. a vaccination program should aim at % coverage at appropriate times, including infants, school children, and adults. immunization policy should be adapted from current international standards applying the best available program to national circumstances and financial capacities (table . ). public health personnel with expertise in vaccine-preventable disease control are needed to advise ministries of health and the practicing pediatric community on current issues in vaccination and to monitor implementation and evolution of control programs. controversies and changing views are common to immunization policy, so that discussions must be conducted on a continuing basis. policy should be under continuing review by a ministerially appointed national immunization advisory committee, including professionals from public health, academia, immunology, laboratory sciences, economics, and relevant clinical fields. bduring , the recommendation for polio virus was changed to doses of ipv in infancy. vaccine supply should be adequate and continuous. supplies should be ordered from known manufacturers meeting international standards of good manufacturing practice. all batches should be tested for safety and efficacy prior to release for use. there should be an adequate and continuously monitored cold chain to protect against high temperatures for heat labile vaccines, sera, and other active biological preparations. the cold chain should include all stages of storage, transport, and maintenance at the site of usage. only disposable syringes should be used in vaccination programs to prevent any possible transmission of blood-borne infection. a vaccination program depends on a readily available service with no barriers or unnecessary prerequisites, free to parents or with a minimum fee, to administer vaccines in disposable syringes by properly trained individuals using patientoriented and community-oriented approaches. ongoing education and training on current immunization practices are needed. incentive payments by insuring agency or managed care systems promote complete, on-time coverage. all clinical encounters should be used to screen, immunize, and educate parents/guardians. contraindications to vaccination are very few; vaccines may be given even during mild illness with or without fever, during antibiotic therapy, during convalescence from illness, following recent exposure to an infectious disease, and to persons having a history of mild/moderate local reactions, convulsions, or family history of sudden infant death syndrome (sids). simultaneous administration of vaccines and vaccine "cocktails" reduces the number of visits and thereby improves coverage; there are no known interferences between vaccine antigens. accurate and complete recording with computerization of records with automatic reminders helps promote compliance, as does co-scheduling of immunization appointments with other services. adverse events should be reported promptly, accurately, and completely. a tracking system should operate with reminders of upcoming or overdue immunizations; use mail, telephone, and home visits, especially for high risk families, with semiannual audits to assess coverage and review patient records in the population served to determine the percentage of children covered by second birthday. tracking should identify children needing completion of the immunization schedule and assess the quality of documentation. it is important to maintain up-to-date, easily retrievable medical protocols where vaccines are administered, noting vaccine dosage, contraindications, and management of adverse events. all health care providers and managers should be trained in education, promotion, and management of immunization policy. health education should target parents as well as the general public. monitoring of vaccines used and children immunized, individually and by category of vaccination can be facilitated by computerization of immunization records, or regular manual review of child care records. where immunization is done by physicians in private practice, as in the united states, determination of coverage is by periodic surveys. inspection of vaccines for safety, purity, potency, and standards is part of the regulatory function. vaccines are defined as biological products and are therefore subject to regulation by national health authorities. in the united states, this comes under the legislative authority of the public health service act, as well as the food, drug and cosmetics act, with applicable regulations in the code of federal regulations. the federal agency empowered to carry out this regulatory function is the center for drugs and biologics of the federal food and drug administration. litigation regarding adverse effects of vaccines led to inflation of legal costs and efforts to limit court settlements. the u.s. federal government enacted the child vaccine injury act of . this legislation requires providers to document vaccines given and to report on complications or reactions. it was intended to pay benefits to persons injured by vaccines faster and by means of a less expensive procedure than a civil suit for resolving claims. using this no-fault system, petitioners do not need to prove that manufacturers or vaccine givers were at fault. they must only prove that the vaccine is related to the injury in order to receive compensation. the vaccines covered by this legislation include dtp, mmr, opv, and ipv. development of vaccines from jenner in eighteenth century to the advent of recombinant hepatitis b vaccine in , and of vaccines for acellular pertussis, varicella, hepatitis a, and rotavirus in the s, has provided one of the pillars of public health and led to enormous savings of human life. vaccines for viral in-fections in humans for hiv, respiratory syncytial virus, papilloma, epstein-barr virus, dengue fever, and hantavirus are under intense research with genetic approaches using recombinant techniques. the potential for the future of vaccines will be greatly influenced by scientific advances in genetic engineering, with potential for development of vaccines attached to bacteria or protein in plants, which may be given in combination for an increasing range of organisms or their harmful products. recombinant dna technology has revolutionized basic and biomedical research since the s. the industry of biotechnology has produced important diagnostic tests, such as for hiv, with great potential for vaccine development. traditional whole organism vaccines, alive or killed, may contain toxic products that may cause mild to severe reactions. subunit vaccines are prepared from components of a whole organism. this avoids the use of live organisms that can cause the disease or create toxic products which cause reactions. subunit vaccines traditionally prepared by inactivation of partially purified toxins are costly, difficult to prepare, and weakly immunogenic. recombinant techniques are an important development for production of new whole cell or subunit vaccines that are safe, inexpensive, and more productive of antibodies than other approaches. their potential contribution to the future of immunology is enormous. molecular biology and genetic engineering have made it feasible to create new, improved, and less costly vaccines. new vaccines should be inexpensive, easily administered, capable of being stored and transported without refrigeration, and given orally. the search for inexpensive and effective vaccines for groups of viruses causing diarrheal diseases led to development of the rotavirus vaccine. some "edible" research focuses on the genetic programming of plants to produce vaccines and dna. vaccine manufacturers, who spend huge sums of money and years of research on new products, tend to work on those which will bring great financial rewards for the company and are critical to the local health care community. this has led to less effort being made in developing vaccines for diseases such as malaria. yet industry plays a crucial role for continued progress in the field. since the eradication of smallpox, much attention has focused on the possibility of similarly eradicating other diseases, and a list of potential candidates has emerged. some of these have been abandoned because of practical difficulties with current technology. diseases that have been under discussion for eradication have included measles, tb, and some tropical diseases, such as malaria and dracunculiasis. eradication is defined as the achievement of a situation whereby no further cases of a disease occur anywhere and continued control measures are unnecessary. reducing epidemics of infectious diseases, through control and eradication in selected areas or target groups, can in certain instances achieve eradication of the disease. local eradication can be achieved where domestic circulation of an organism is interrupted with cases occurring from importation only. this requires a strong, sustained immunization program with adaptation to meet needs of importation of carriers and changing epidemiologic patterns. smallpox was one of the major pandemic diseases of the middle ages and its recorded history goes back to antiquity. prevention of smallpox was discussed in ancient china by ho kung (circe ao ), and inoculation against the disease was practiced there from the eleventh century ad. prevention was carried out by nasal inhalation of powdered dried smallpox scabs. exposure of children to smallpox when the mortality rate was lowest assumed a weakened form of the disease, and it was observed that a person could only have smallpox once in a lifetime. isolation and quarantine were widely practiced in europe during the sixteenth and seventeenth centuries. variolation was the practice of inoculating youngsters with material from scabs of pustules from mild cases of smallpox in the hope that they would develop a mild form of the disease. although this practice was associated with substantial mortality, it was widely adopted because mortality from variolation was well below that of smallpox acquired during epidemics. introduced into england in (see chapter ) it was commonly practiced as a lucrative medical specialty during the eighteenth century. in the s, variolation was also introduced into the american colonies, russia, and subsequently into sweden and denmark. despite all efforts, in the early eighteenth century smallpox was a leading cause of death in all age groups. toward the end of the eighteenth century an estimated , persons died annually from smallpox in europe. vaccination, or the use of cowpox vaccinia virus to protect against smallpox, was initiated late in the eighteenth century. in , a cattle breeder in yorkshire, england, inoculated his wife and two children with cowpox to protect them during a smallpox epidemic. in , edward jenner, an english country general practitioner, experimented with inoculation from a milkmaid's cowpox pustule to a healthy youngster, who subsequently proved resistant to smallpox by variolation (see chapter ). vaccination, the deliberate inoculation of cowpox material, was slow to be adopted universally, but by , over , persons in england were vaccinated. vaccination gathered support in the nineteenth century in military establishments, and in some countries which adopted it universally. opposition to vaccination remained strong for nearly a century based on religious grounds, observed failures of vaccination to give lifelong immunity, and because it was seen as an infringement of the state on the rights of the individual. often the protest was led by medical variolationists whose medical practice and large incomes were threatened by the mass movement to vaccination. resistance was also offered by "sanitarians" who opposed the germ theory and thought cleanliness was the best method of prevention. universal vaccination was increasingly adopted in europe and america in the early nineteenth century and eradication of smallpox in developed countries was achieved by the mid twentieth century. in , the soviet union proposed to the world health assembly a program to eradicate smallpox internationally and subsequently donated million doses of vaccine per year as part of the million needed to promote vaccination of at least % of the world population. in , who adopted a target for the eradication of smallpox. a program was developed which included a massive increase in coverage to reduce the circulation of the virus through person-to-person contact. where smallpox was endemic, with a substantial number of unvaccinated persons, the aim of the mass vaccination phase was % coverage. increasing vaccination coverage in developing countries reduced the disease to periodic and increasingly localized outbreaks. in , countries were considered endemic for smallpox, and another experienced importation of cases. by , the number of endemic countries was down to , and by only countries were still endemic, including india, pakistan, bangladesh, and nepal. in these countries, a new strategy was needed, based on a search for cases and vaccination of all contacts, working with a case incidence below per , . the program then moved into the consolidation phase, with emphasis on vaccination of newborns and new arrivals. surveillance and case detection were improved with case contact or risk group vaccination. the maintenance phase began when surveillance and reporting were switched to the national or regional health service with intensive follow-up of any suspect case. the mass epidemic era had been controlled by mass vaccination, reducing the total burden of the disease, but eradication required the isolation of individual cases with vaccination of potential contacts. technical innovations greatly eased the problems associated with mass vaccination worldwide. during the s, there was wide variation in sources of smallpox vaccine. in the s, efforts to standardize and further attenuate the strains used reduced complication rates from vaccinations. the development of lyophilization (freeze-drying) of the vaccine in england in the s made a heat-stable vaccine that could be effective in tropical field conditions in developing countries. the invention of the bifurcated needle (bernard rubin ) allowed for easier and more widespread vaccination by lesser trained personnel in remote areas. the net result of these innovations was increased world coverage and a reduction in the spread of the disease. smallpox became more and more confined by increasing herd immunity, thus allowing transition to the phase of monitoring and isolation of individual cases. in the last case of smallpox was identified in somalia, and in the who declared the disease eradicated. no subsequent cases have been found except for several associated with a laboratory accident in the united kingdom in . the who recommends that the last stores of smallpox virus should be destroyed in . the cost of the eradication program was $ million or $ million per year. worldwide savings are estimated at $ billion annually. this monumental public health achievement set the precedent for eradication of other infectious diseases. the world health assembly decided to destroy the last two remaining stocks of the smallpox virus in atlanta and moscow in . destruction of the remaining stock was delayed in to because of concern that illegal stocks may be held by some states or potential bioterrorists for potential use in weapons of mass destruction, concern regarding the appearance of monkeypox and a wish to use the virus for further research. in , the who established a target of eradication of poliomyelitis by the year . global immunization coverage with three doses of opv increased from some % in to over % in , with a slight decline in the period - . support from member countries and international agencies such as unicef and rotary international has led to widescale increases in immunization coverage throughout many parts of the world. the world health organization promotes use of opv only as part of routine infant immunization or national immunization days (nids). this strategy has been successful in the americas and in china, but india and the middle east remain problematic. eradication of wild poliomyelitis by the year will require flexibility in vaccination strategies and may require the combined approach, using opv and ipv, as adopted in the united states in to prevent vaccine-associated clinical cases. the combination of opv and ipv may be needed where enteric disease is common and leads to interference in opv uptake, especially in tropical areas where endemic poliovirus and diarrheal diseases are still found. the world bank estimated that achievement of global eradication would save $ million annually in the united states alone. since the eradication of smallpox, discussion has focused on the possibility of similarly eradicating other diseases, and a list of potential candidates has emerged. some of these have been abandoned because of practical difficulties with current technology. diseases that have been under discussion for eradication have included measles, tb, and tropical diseases such as malaria and dracunculiasis. eradication of malaria was thought to be possible in the s when major gains were seen in malaria control by aggressive case environmental control, case finding, and management. however, lack of sustained vector control and an effective vaccine has prevented global eradication. malaria control suffered serious setbacks because of failure in political resolve and capacity to continue support needed for necessary programs. in the s and s, control efforts were not sustained in many countries, and a dreadful comeback of the disease occurred in africa and asia in the s. the emergence of mosquitoes resistant to insecticides, and malarial strains resistant to antimalarial drugs, have made malaria control even more difficult and expensive. renewed effort in malaria control may require new approaches. use of community health workers (chws) in small villages in highly endemic regions of colombia resulted in a major drop in malaria mortality during the s. the chws investigate suspect cases by taking clinical histories and blood smears. . scientific feasibility a. epidemiologic vulnerability; lack of nonhuman reservoir, ease of spread, no natural immunity, relapse potential; b. effective practical intervention available; vaccine or other primary preventive or curative treatment, or vectoricide that is safe, inexpensive, long lasting, and easily used in the field; c. demonstrated feasibility of elimination in specific locations, such as an island or other geographic unit. . political will/popular support a. they examine smears for malaria parasites and a diagnosis is made. therapy is instituted and the patient is followed. quality control monitoring shows high levels of accuracy in reading of slides compared to professional laboratories. in the late s, there was widespread discussion in the literature of the potential for eradication of measles and tb. measles eradication was set back as breakthrough epidemics occurred in the united states, canada, and many other countries during the s and early s, but regional eradication was achieved combining the two-dose policy with catch-up campaigns for older children or in national immunization days, as in the caribbean countries. tuberculosis has also increased in the united states and several european countries for the first time in many decades. unrealistic expectations can lead to inappropriate assessments and policy when confounding factors alter the epidemiologic course of events. such is the case with tb, where control and eradication have receded from the picture. this deadly disease has returned to developed countries, partly in association with the hiv infection and multiple-drug-resistant strains, as well as homelessness, rising prison populations, poverty, and other deleterious social conditions. directly observed therapy is an important recent breakthrough, more effective in use of available technology and will play a major role in tb control in the twenty-first century. a decade after the eradication of smallpox was achieved, the international task force for disease eradication (itfde) was established to systematically evaluate the potential for global eradicability of candidate diseases. its goals were to identify specific barriers to the eradication of these diseases that might be surmountable and to promote eradication efforts. the subject of eradication versus control of infectious diseases if of central public health importance as technology expands the armamentarium of immunization and vector control into the twenty-first century. the control of epidemics, followed by interruption of transmission and ultimately eradication, will save countless lives and prevent serious damage to children throughout the world. the smallpox achievement, momentous in itself, points to the potential for the eradication of other deadly diseases. the skillful use of existing and new technology is an important priority in the new public health. flexibility and adaptability are as vital as resources and personnel. selecting diseases for eradication is not purely a professional issue of resources such as vaccines and manpower, organization and financing. it is also a matter of political will and perception of the burden of disease. there will be many controversies. the selection of polio for eradication while deferring measles when polio kills few and measles kills many may be questioned. the cdc published criteria for selection of disease for eradication are shown in box . . the who, in a review of health targets in the field of infectious disease control for the twenty-first century, selected the following targets: eradication of chagas' disease by ; eradication of neonatal tetanus by ; eradication of leprosy by ; eradication of measles by ; eradication of trachoma by ; reversing the current trend of increasing tuberculosis and hiv/aids. in , a conference in atlanta, georgia, reviewed the subject, which is still very much in a state of flux. table . summarizes the selection of diseases which are presently seen as controllable and those considered to be potentially eradicable. the subject will be under review in the years ahead. mycobacterium tuberculosis in humans and m. bovis in cattle. the disease is primarily found in humans, but it is also a disease of cattle and occasionally other primates in certain regions of the world. it is transmitted via airborne droplet nuclei from persons with pulmonary or laryngeal tb during coughing, sneezing, talking, or singing. the initial infection may go unnoticed, but tuberculin sensitivity appears within a few weeks. about % of those infected enter a latent phase with a lifelong risk of reactivation. approximately % go from initial infection to pulmonary tb. less commonly, the infection develops as extrapulmonary tb, involving meninges, lymph nodes, pleura, pericardium, bones, kidneys, or other organs. untreated, about half of the patients with active tb will die of the disease within years, but modern chemotherapy almost always results in a cure. pulmonary tb symptoms include cough and weight loss, with clinical findings on chest examination and confirmation by findings of tubercle bacilli in stained smears of sputum and, if possible, growth of the organism on culture media, and changes in the chest x-ray. tuberculosis affects people in their adult working years, with - % of cases in persons between the ages of and . its devastating effects on the work force and economic development contribute to a high cost-effectiveness for tb control. the tubercle bacillus infects approximately . billion people in the world today, causing over million cases and nearly million deaths in . during , new cases of tb included . million ( %) in southeast asia and the western pacific regions of who, with . million cases in india, and . million in indonesia. by , the incidence of tb may increase to . million new cases per year, a % increase over . between and , who estimates there were million new cases of tb, of which million cases were in association with hiv infection. during the s, an estimated million persons died of tb, including . million with hiv infection. a new and dangerous period for tb resurgence has resulted from parallel epidemiologic events: first, the advent of hiv infection and second, the occurrence of multiple drug resistant tb (mdrtb), that is, organisms resistant at least to both isoniazid (inh) and rifampicin, two mainstays of tb treatment. mdrtb can have a case fatality rate as high as %. hiv reduces cellular immunity so that people with latent tb have a high risk of activation of the disease. it is estimated that hiv negative persons have a - % lifetime risk of tb; hiv positive people have a risk of % per year of developing clinical tuberculosis. drug resistance, the long period of treatment, and the socioeconomic profile of most tb patients combine to require a new approach to therapy. directly observed treatment, short-course (dots), has shown itself to be highly effective with patients in poor self-care settings, such as the homeless, drug users, and those with aids. the strategy of dots uses community health workers to visit the patient and observes him or her taking the various medications, providing both incentive, support, and moral coercion to complete the needed to month therapy. dots has been shown to cure up to % of cases, at a cost of as little as $ per patient. it is one of the few hopes of containing the tb pandemic. in , who released a new strategy for control of tuberculosis over the next decade. the plan calls for new guidelines for control, new aid funds for developing countries, and enlistment of ngos to assist in the fight. the new guidelines stress short-term chemotherapy in well-managed programs of dots, stressing strict compliance with therapy for infectious cases with a goal of an % cure rate. even under adverse conditions, dots produces excellent results. it is one of the most cost-effective health interventions combining public health and clinical medical approaches. tuberculosis incidence in the united states decreased steadily until , increased in , and has declined again since. from to , there was an excess of , cases over the expected rate if the previous decline in case incidence had continued. this rise was largely due to the hiv/aids epidemic and the emergence of mdrtb, but also greater incidence among immigrants from areas of higher tb incidence, drug abusers, the homeless, and those with limited access to health care. this is particularly true in new york city, where mdrtb has appeared in outbreaks among prison inmates and hospital staff. from to , tb incidence in the united states declined by % and in some states, including new york, by % or more. this turnaround was due to stronger tb control programs that promptly identified persons with tb and initiated and ensured completion of appropriate therapy. aggressive staff training, outreach, and case management approaches were vital to this success. concern over rising rates among recent immigrants and the continued challenge of hiv/aids and coincidental transmission of hepatitis a, b, and c among drug users and marginal population groups show that continued support for tb control is needed. bacillus calmette-gurrin (bcg) is an attenuated strain of the tubercle bacillus used widely as a vaccination to prevent tb, especially in high incidence areas. it induces tuberculin sensitivity or an antigen-antibody reaction in which antibodies produced may be somewhat protective against the tubercle bacillus in % of vaccinees. although the support for its general use is contradictory, there is evidence from case-control and contact studies of positive protection against tb meningitis and disseminated tb in children under the age of . in some developed, low-incidence countries, it is not used routinely but selectively. it may also be used in asymptomatic hiv-positive persons or other high risk groups. the bcg vaccine for tuberculosis remains controversial. while used widely internationally, in the united states and other industrialized countries, it is thought to hinder rather than help in the fight against tb. this concern is based on the usefulness of tuberculin testing for diagnosis of the disease. where bcg has been administered, the diagnostic value of tuberculin testing is reduced, especially in the period soon after the bcg is used. studies showing equivocal benefit of bcg in preventing tuberculosis have added to the controversy. while those in the field in the united states continue to oppose the use of bcg, internationally it is still felt to be of benefit in preventing tb, primarily in children. a metaanalysis of the literature of bcg carried out by the technology assessment group at harvard school of public health concluded: on average, bcg vaccine significantly reduces the risk of tb by %. protection is observed across many populations, study designs, and forms of tb. age at vaccination did not enhance predictiveness of bcg efficacy. protection against tuberculous death, meningitis, and disseminated disease is higher than for total tb cases, although this result may reflect reduced error in disease classification rather than greater bcg efficacy. [colditz et al., jama, .] box . control of tuberculosis . identifying persons with clinically active tb; . diagnostic methods--clinical suspicion, sputum smear for bacteriologic examination, tuberculin skin testing, chest radiograph; . case finding and investigation programs in high risk groups; . contact investigation; . isolation techniques during initial therapy; . treatment, mainly ambulatory, of persons with clinically active tb; . treatment of contacts; . directly observed treatment, short-course (dots), where compliance suspect; . environmental control in treatment settings to reduce droplet infection; . educate health care providers on suspicion of tb and investigation of suspects. currently, the who recommends use of bcg as close to birth as possible as part of the expanded programme of immunization (epi). tuberculosis control remains feasible with current medical and public health methods. deterioration in its control should not lead to despair and passivity. the recent trend to successful control by dots despite the growing problem of mdrtb suggest that control and gradual reduction can be achieved by an activist, community outreach approach. the who in made tb control one of its major priorities, expressing grave concern that the mdr organism, now widely spread in countries of asia, eastern europe, and the former soviet union, may spread the disease much more widely. the disease constitutes one of the great challenges to public health at the start of the new century. acute infectious diseases caused by group a streptococci include streptococcal sore throat, scarlet fever, puerperal fever, septicemia, ersypelas, cellulitis, mastoiditis, otitis media, pneumonia, peritonsillitis (quinsy), wound infections, toxic shock syndrome, and fasciitis, the "flesh eating bacteria." streptococcus pyogenes group a include some serologically distinct types which vary in geographic location and clinical significance. transmission is by droplet, person-to-person direct contact, or by food infected by carriers. important complications from a public health point of view include acute rheumatic fever and acute glomerulonephritis, but also skin infections and pneumonia. acute rheumatic fever is a complication of strep a infection that has virtually disappeared from industrialized countries as a result of improved standards of living and antibiotic therapy. however, outbreaks were recorded in the united states in , and an increasing number of cases have been seen since . in developing countries, rheumatic fever remains a serious public health problem affecting school age children, particularly those in crowded living arrangements. longterm sequelae include disease of the mitral and aortic heart valves, which require cardiac care and surgery for repair or replacement with artificial valves. acute glomerulonephritis is a reaction to toxins of the streptococcal infection in the kidney tissue. this can result in long-term kidney failure and the need for dialysis or kidney transplantation. this disease has become far less common in the industrialized countries, but remains a public health problem in developing countries. the streptococcal diseases are controllable by early diagnosis and treatment with antibiotics. this is a major function of primary care systems. recent increases in rheumatic fever may herald a return of the problem, perhaps due to inadequate access to primary care in the united states for large sectors of the population, along with increased social hygiene problems. where access to primary care services is limited, infections with streptococci can result in a heavy burden of chronic heart and kidney disease with substantial health, emotional, and financial tolls. measures to improve access to care and pub-lic information are needed to assure rapid and effective care to prevent chronic and costly conditions. zoonoses are infectious diseases transmissible from vetebrate animals to humans. common examples of zoonoses of public health importance in nonindustrialized countries include brucellosis and rabies. in industrialized countries, salmonellosis, "mad cow disease" and influenza have reinforced the importance of relationships of animal and human health. strong cooperation between public health and veterinary public health authorities are required to monitor and to prevent such diseases. brucellosis is a disease occurring in cattle (brucella abortus), in dogs (br. cahis), in goats and sheep (br. melitensis), and in pigs (br. suis). humans are affected mainly through ingestion of contaminated milk products, by contact, or inhalation. brucellosis (also known as relapsing, undulant, malta, or mediterranean fever) is a systemic bacterial disease of acute or insidious onset characterized by fever, headache, weakness, sweating, chills, arthralgia, depression, weight loss, and generalized malaise. spread is by contact with tissues, blood, urine, vaginal discharges, but mainly by ingestion of raw milk and dairy products from infected animals. the disease may last from a few days to a year or more. complications include osteoarthritis and relapses. case fatality is under %, but disability is common and can be pronounced. the disease is primarily seen in mediterranean countries, the middle east, india, central asia, and in central and south america. brucellosis occurs primarily as an occupational disease of persons working with and in contact with tissues, blood, and urine of infected animals, especially goats and sheep. it is an occupational hazard for veterinarians, packinghouse workers, butchers, tanners, and laboratory workers. it is also transmitted to consumers of unpasteurized milk from infected animals. animal vectors include wild animals, so that eradication is virtually impossible. diagnosis is confirmed by laboratory findings of the organism in blood or other tissue samples, or with rising antibody titers in the blood, with confirmation by blood cultures. clinical cases are treated with antibiotics. epidemiologic investigation may help track down contaminated animal flocks. routine immunization of animals, monitoring of animals in high risk areas, quarantining sick animals, destroying infected animals, and pasteurizing milk and milk products prevents spread of the disease. control measures include educating farmers and the public not to use unpasteurized milk. individuals who work with animals (cattle, swine, goats, sheep, dogs, coyotes) should take special precautions when handling animal carcasses and materials. testing animals, destroying carriers, and enforcing mandatory pasteurization will restrict the spread of the disease. this is an economic as well as public health problem, requiring full cooperation between ministries of health and of agriculture. rabies is primarily a disease of animals, with a variety of wild animals serving as a reservoir for this disease, including foxes, wolves, bats, skunks, and raccoons, who may infect domestic animals such as dogs, cats, and farm animals. animal bites break the skin or mucous membrane, allowing entry of the virus from the infected saliva into the bloodstream. the incubation period of the virus is - weeks; it can be as long as several years or as short as days, so that postexposure preventive treatment is a public health emergency. the clinical disease often begins with a feeling of apprehension, headache, pyrexia, followed by muscle spasms, acute encephalitis, and death. fear of water ("hydrophobia") or fear of swallowing is a characteristic of the disease. rabies is almost always fatal within a week of onset of symptoms. the disease is estimated to cause , deaths annually, primarily in developing countries. it is uncommon in developed countries. rabies control focuses on prevention in humans, domestic animals, and wildlife. prevention in humans is based on preexposure prophylaxis for groups at risk (e.g., veterinarians, zoo workers) and postexposure immunization for persons bitten by potentially rabid animals. because reducing exposure of pets to wild animals is difficult, immunization of domestic animals is one of the most important preventive measures. prevention in domestic animals is by mandatory immunization of household pets. all domestic animals should be immunized at age months and revaccinated according to veterinary instructions. prevention in wild animals to reduce the reservoir is successful in achieving local eradication in settings where reentry from neighboring settings is limited. since , the use of oral rabies immunization has been successful in reducing the population of wild animals infected by the rabies virus. rabies eradication efforts, using aerial distribution of baits containing fox rabies vaccine in affected areas of belgium, france, germany, italy, and luxembourg, have been underway since . the number of rabies cases in these affected areas has declined by some %. switzerland is now virtually rabies-free because of this vaccination program. the potential exists for focal eradication, especially on islands or in partially restricted areas with limited possibilities of wild animal entry. livestock need not be routinely immunized against rabies, except in high risk areas. where bats are major reservoirs of the disease, as in the united states, eradication is not presently feasible. salmonella, discussed later in this chapter under diarrheal diseases, is one of the commonest of all infectious diseases among animals and is easily spread to humans via poultry, meat, eggs, and dairy products. specific antigenic types are associated with food-borne transmission to humans, causing generalized illness and gastroenteritis. severity of the disease varies widely, but the diseases can be devastating among vulnerable population groups, such as young children, the elderly, and the immunocompromised. epidemiologic investigation of common food source outbreaks may uncover hazardous food handling practices. laboratory confirmation or serotypes helps in monitoring the disease. prevention is by maintaining high standards of food hygiene in processing, inspection and regulation, food handling practices, and hygiene education. bacillus anthracis causes a bacterial infection in herbivore animals. its spores contaminate soil, worldwide. it affects humans exposed in occupational settings. transmission is cutaneous by contact, gastrointestinal by ingestion, or respiratory by inhalation. it has gained recent attention (iraq, ) as a highly potent agent for germ warfare or terrorism. limited supplies of vaccine are available. creutzfeld-jakob disease is a degenerative disease of the central nervous system linked to consumption of beef from cattle infected with bovine spongiform encephalopathy. it is transmitted by prions in animal feed prepared from contaminated animal material and in transplanted organs. this disease was identified in the united kingdom linked to infected cattle leading to a ban on british beef in many parts of the world and slaughter of large numbers of potentially contaminated animals. the tapeworm causing diphyllobothriasis (diphyllobothrium latum) is widespread in north american freshwater fish, passing from crustacean to fish to humans by eating raw freshwater fish. it is especially common among inuit peoples and may be asymptomatic or cause severe general and abdominal disorder. food hygiene (freezing and cooking of meat) is recommended; treatment is by anthelminthics. leptospiroses are a group of zoonotic bacterial diseases found worldwide in rats, raccoons, and domestic animals. it affects farmers, sewer workers, dairy and abattoir workers, veterinarians, military personnel, and miners with transmission by exposure to or ingestion of urine-contaminated water or tissues of infected animals. it is often asymptomatic or mild, but may cause generalized illness like influenza, meningitis, or encephalitis. prevention requires education of the public in self protection and immunization of workers in hazardous occupations, along with immunization and segregation of domestic animals and control of wild animals. vector-borne diseases are a group of diseases in which the infectious agent is transmitted to humans by crawling or flying insects. the vector is the intermediary between the reservoir and the host. both the vector and the host may be affected by climatic condition; mosquitoes thrive in warm, wet weather and are suppressed by cold weather; humans may wear less protective clothing in warm weather. the only important reservoir of malaria is humans. its mode of transmission is from person to person via the bite of an infected female anopheles mosquito (ronald ross, nobel prize, ) . the causative organism is a single cell parasite with four species: plasmodium vivax, p malariae, p falciparum, and p ovale. clinical symptoms are produced by the parasite invading and destroying red blood cells. the incubation period of approximately - days, depending on the specific plasmodium involved. some strains of p vivax may have a protracted incubation period of - months and even longer for p ovale. the disease can also be transmitted through infected blood transfusions. confirmation of diagnosis is by demonstrating malaria parasites on blood smears. falciparum malaria, the most serious form, presents with fever, chills, sweats, and headache. it may progress to jaundice, bleeding disorders, shock, renal or liver failure, encephalopathy, coma, and death. prompt treatment is essential. case fatality rates in untreated children and adults are above %. an untreated attack may last months. other forms of malaria may present as a nonspecific fever. relapse of the p ovale may occur up to years after initial infection; malaria may persist in chronic form for up to years. malaria control advanced during the s- s through improved chlovaquine treatment and use of ddt for vector control with optimism for eradication of the disease. however, control regressed in many developing countries as allocations for environmental control and case findings/treatment were reduced. there has also been an increase in drug resistance, so that this disease is now an extremely serious public health problem in many parts of the world. the need for a vaccine for malaria control is now more apparent than ever. the world health organization estimated that, in , sub-saharan africa (ssa) had million new malaria cases, with % of children up to age . over million deaths occur annually from malaria more than two-thirds of them in ssa. large areas, particularly in forest or savannah regions with high rainfall, are holoendemic. in higher altitudes, endemicity is lower, but epidemics do occur. chloroquine-resistant p. falciparum has spread throughout africa, accompanied by an increasing incidence of severe clinical forms of the disease. the world bank estimates that % of all disability-adjusted life years (dalys) lost per year in ssa are from malaria, which places a heavy economic burden on the health systems. in the americas, the number of cases detected has risen every year since , and the who estimates there to have been . - . million cases in . the nine most endemic countries in the americas achieved a % reduction in malaria mortality between and . southeast asian region reports some . million cases of malaria in and deaths from tb. this accounts for more than one-third of all non-african malaria cases. there is an increase in resistant strains to the major available drugs and of the mosquitoes to insecticides in use. vector control, case finding, and treatment remain the mainstay of control. use of insecticide-impregnated bed nets and curtains, and residual house spraying, and strengthened vector control activities are important, as are early diagnosis and carefully monitored treatment with monitoring for resistance. control of malaria will ultimately depend on a safe, effective, and inexpensive vaccine. attempts to develop a malaria vaccine have been unsuccessful to date due to the large number of genetic types of p. falciparum even in localized areas. a colombian-developed vaccine is being field-tested with partial effectiveness. research in vaccines for malaria has also been hampered by the fact that it is a relatively low priority for vaccine manufacturers because of the minimal potential for financial benefit. research on malaria concentrates on the pharmacological aspects of the disease because of increasing drug resistance. in , who has initiated a new campaign to "roll back malaria" and maintain the dream of eradication in the future. effective low technology interventions include community-based case finding, early treatment of good quality, insecticide use, and vector control. the use of community health workers in endemic areas, has shown promising results. local control and even eradication can be achieved with currently available technology. this requires an integration of public health and clinical approaches with strong political commitment. the rickettsia are obligate parasites, i.e., they can only replicate in living cells, but otherwise they have characteristics of bacteria. this is a group of clinically similar diseases, usually characterized by severe headache, fever, myalgia, rash, and capillary bleeding causing damage to brain, lungs, kidneys, and heart. identification is by serological testing for antibodies, but the organisms can also be cultured in laboratory animals, embryonic eggs, or in cell cultures. the organisms are transmitted by arthropod vectors such as lice, fleas, ticks, and mites. the diseases caused millions of deaths during war and famine periods prior to the advent of antibiotics. these diseases appear in nature in ways that make them impossible to eradicate, but clinical diagnosis, host protection, and vector control can help reduce the burden of disease and deal with outbreaks that may occur. public education regarding self-protection, appropriate clothing, tick removal, and localized control measures such as spraying and habitat modification are useful. epidemic typhus, first identified in , is due to rickettsia prowazekii. spread primarily by the body louse, typhus was the cause of an estimated million deaths, i.e., during war and famine, in poland and the soviet union from - . untreated, the fatality rate is - %. typhus responds well to antibiotics. it is currently largely confined to endemic foci in central africa, central asia, eastern europe, and south america. it is preventable by hygiene and pediculicides such as ddt and lindane. a vaccine is available for exposed laboratory personnel. murine typhus is a mild form of typhus due to rickettsia typhi, which is found worldwide and spread in rodent reservoirs. scrub typhus, also known as tsutsugamushi or japanese river fever, is located throughout the far east and the pacific islands, and was a serious health problem for u.s. armed forces in the pacific during world war ii. it is spread by the rickettsia tsutsugamushi and has a wide variation in case fatality according to region, organism, and age of patient. rocky mountain spotted fever is a well-known and severe form of tick-borne typhus due to rickettsia rickettsii, occurring in western north america, europe, and asia. q. fever is a tick-borne disease caused by coxiella burnetii and is worldwide in distribution, usually associated with farm workers, in both acute and chronic forms. regular anti-tick spraying of sheep, cows, and goats helps protect exposed workers. protective clothing and regular removal of body ticks help protect exposed persons. arthropod-borne viral diseases are caused by a diverse group of viruses which are transmitted between vertebrate animals (often farm animals or small rodents) and people by the bite of blood-feeding vectors such as mosquitoes, ticks, and sandflies and by direct contact with infected animal carcasses. usually the viruses have the capacity to multiply in the salivary glands of the vector, but some are carried mechanically in their mouthparts. these viruses cause acute central nervous system infections (meningoencephalitis), myocarditis, or undifferentiated viral illnesses with polyarthritis and rashes, or severe hemorrhagic febrile illnesses. arbovirus diseases are often asymptomatic in vertebrates but may be severe in humans. over antigenetically distinct arboviruses are associated with disease in humans, varying from benign fevers of short duration to severe hemmorhagic fevers. each has a specific geographic location, vector, clinical, and virologic characteristics. they are of international public health importance because of the potential for spread via natural phenomena and modem rapid transportation of vectors and persons incubating the disease or ill with it, with potential for further spreading at the point of destination. arboviruses are responsible for a large number of encephalitic diseases characterized by mode of transmission and geographic area. mosquito-borne arboviruses causing encephalitis include eastern and western equine, venezuelan, japanese, and murray hill encephalitides. japanese encephalitis is caused by a mosquito-borne arbovirus found in asia and is associated with rice-growing areas. it is characterized by headache, fever, convulsions, and paralysis, with fatality rates in severe cases as high as %. a currently available vaccine is used routinely in endemic areas (japan, korea, thailand, india, and taiwan) and for persons traveling to infected areas. tick-borne arboviruses causing encephalitis include the powassan virus, which occurs sporadically in the united states and canada. tickborne encephalitis is endemic in eastern europe, scandinavia, and the former soviet union. an epidemic of mosquito-borne encephalitis in new york city in included cases and deaths, due to the west nile fever virus, never before found in the united states. other insect vectors. it affects animals and humans who are in direct contact with the meat or blood of affected animals. the virus causes a generalized illness in humans with encephalitis, hemorrhages, retinitis and retinal hemorrhage leading to partial or total blindness, and death ( - %). it also causes universal abortion in ewes and a high percentage of death in lambs. the normal habitat is in the rift valley of eastern africa (the great syrian-african rift), often spreading to southern africa, depending on climactic conditions. the primary reservoir and vector is the aedes mosquito, and affected animals serve to multiply the virus which is transmitted by other vectors and direct contact with animal fluids to humans. an unusual spread of rvf northward to the sudan and along the aswan dam reservoir to egypt in - caused hundreds of thousands of animal deaths, with , human cases and deaths. rvf appeared again in egypt in . this disease is suspected to be one of the ten plagues of egypt leading to the exodus of the children of israel from egypt during pharaonic-biblical times. in , an outbreak of rvf in kenya, initially thought to be anthrax, with hundreds of cases and dozens of deaths, was related to abnormal rainy season and vector conditions. satellite monitoring of rainfall and vegetation is being used to predict epidemics in kenya and surrounding countries. animal immunization, monitoring, vector control, and reduced contact with infected animals can limit the spread of this disease. arboviruses can also cause hemorrhagic fevers. these are acute febrile illnesses, with extensive hemorrhagic phenomena (internal and external), liver damage, shock, and often high mortality rates. the potential for international transmission is high. yellow fever. yellow fever is an acute viral disease of short duration and varying severity with jaundice. it can progress to liver disease and severe intestinal bleeding. the case fatality rate is < % in endemic areas, but may be as high as % in nonendemic areas and in epidemics. it caused major epidemics in the americas in the past, but was controlled by elimination of the vector, aedes aegypti. a live attenuated vaccine is used in routine immunization endemic areas and recommended for travelers to infected areas. determining the mode of transmission and vector control of yellow fever played a major role in the development of public health (see chapter ). in , the who reported , cases and , deaths from yellow fever globally. dengue hemorrhagic fever. dengue hemorrhagic fever is an acute sudden onset viral disease, with - days of fever, intense headache, myalgia, arthralgia, box . dengue fever and dengue hemorrhagic fever, dengue fever, a severe influenza-like illness, and dengue hemorrhagic fever are closely related conditions caused by four distinct viruses transmitted by aedes aegypti mosquitos. dengue is the world's most important mosquito-borne virus disease. a total of , million people worldwide are at risk of infection. an estimated million cases occur each year, of whom , need to be hospitalized. this is a spreading problem, especially in cities in tropical and subtropical areas. major outbreaks were reported in colombia, cuba, and many other locations in . source: world health organization. . world health report gastrointestinal disturbance, and rash. hemorrhagic phenomena can cause case fatality rates of up to %. epidemics can be explosive, but adequate treatment can greatly reduce the number of deaths. dengue occurs in southeast asia, the pacific islands, australia, west africa, the caribbean, and central and south america. an epidemic in cuba in included more than , cases, and deaths. vector control of the a. aegypti mosquito resulted in control of the disease during the s- s, but reinfestation of mosquitoes led to incresased transmission and epidemics in the pacific islands, caribbean, central and south america in the s and s. outbreaks in vietnam included , cases in , another , cases in , and a similar sized outbreak in . indonesia had over , cases in with deaths, and in over , cases (january-may) with at least deaths. in , epidemics of dengue were reported in fiji, the cook islands, new caledonia, and northern australia. the who estimates , deaths and . million cases worldwide in . monkeys are the main reservoir, and the vector is the a. aegypti mosquito. no vaccine is currently available, and management is by vector control. lassa fever. lassa fever was first isolated in lassa, nigeria, in and is widely distributed in west africa, with , - , cases and deaths annually. it is spread by direct contact with blood, urine, or secretions of infected rodents and by direct person-to-person contact in hospital settings. the disease is characterized by a persistent or spiking fever for - weeks, and may include severe hypotension, shock, and hemorrhaging. the case fatality rate is %. marburg disease. marburg disease is a viral disease with sudden onset of generalized illness, malaise, fever, myalgia, headache, diarrhea, vomiting, rash, and hemorrhages. it was first seen in marburg, germany, in , following ex-posure to green monkeys. person-to-person spread occurs via blood, secretions, organs, and semen. case fatality rates can be over %. ebola fever. ebola fever is a viral disease with sudden onset of generalized illness, malaise, fever, myalgia, headache, diarrhea, vomiting, rash, and hemorrhages. it was first found in zaire and sudan in in outbreaks which killed more than persons. it is spread from person to person by the blood, vomitus, urine, stools, and other secretions of sick patients, with a short incubation period. the disease has case fatality rates of up to %. an outbreak of ebola among laboratory monkeys in a medical laboratory near washington, d.c., was contained with no human cases. the reservoir for the virus is thought to be rodents. an outbreak of ebola in may in the town of kikwit, zaire, killed persons out of cases ( % case fatality rate). this outbreak caused international concern that the disease could spread, but it remained localized. another outbreak of ebola virus occurred in gabon in early , with cases, of whom had direct exposure to an infected monkey, the remainder by human-to-human contact, or not established; of the cases died ( %). this disease is considered highly dangerous unless outbreaks are effectively controlled. in zaire, lack of basic sanitary supplies, such as surgical gloves for hospitals, almost ensures that this disease will spread when it recurs. lyme disease is characterized by the presence of a rash, musculoskeletal, neurologic, and cardiovascular symptoms. confirmation is by laboratory investigation. it is the most common vector-borne disease in the united states, with , cases reported between and . it primarily affects children in the - age group and adults aged - . lyme disease is preventable by avoiding contact with ticks, by applying insect repellant, wearing long pants and long sleeves in infected areas, and by the early removal of attached ticks. several u.s. manufacturers produced vaccines which are approved for animal and human use. in the mid s, a mother of two young boys who were recently diagnosed with arthritis in the town of lyme, connecticut, conducted a private investigation among other town residents. she mapped each of the six arthritis cases in the town, cases which had occurred in a short time span among boys living in close proximity. this suggested that this syndrome of "juvenile rheumatoid arthritis" was perhaps connected with the boys playing in the woods. she presented her data to the head of rheumatology at yale medical school in new haven, who investigated this "cluster of a new disease entity." some parents reported that their sons had experienced tick bites and a rash before onset of the arthritis. a tick-borne, spiral shaped bacterium, a spirochete, borrelia burgdorferi, was identified as the organism, and ticks shown to be the vector. cases repond well to antibiotic therapy. in over , cases ( . per , ) were reported from states, an increase from , in and , in . cases were mainly located in the northeast, north central, and mid-atlantic regions. the disease accounts for over % of vector-borne disease in the united states and was the ninth leading reported infection in . lyme disease has been identified in many parts of north america, europe, the former soviet union, china, and japan. a newly licensed vaccine is effective for people exposed to ticks but not general usage. personal hygiene for protection from ticks and environmental modification are important to limit spread of the disease. source: cdc, , mmwr, : - ; and cdc, , mmwr, , no. . lyme disease website http://www.cdc.gov/ncidad/disease/lyme/lyme.htm medically important parasites are animals that live, take nourishment, and thrive in the body of a host, which may or may not harm the host, but never brings benefit. they include those caused by unicellular organisms such as protozoa, which include amoebas (malaria, schistosomiasis, amebiasis, and cryptosporidium), and helminths (worms), which are categorized as nematodes, cestodes, and trematodes. public health continues to face the problems of parasitic diseases in the developing world. increasingly, parasitic diseases are being recognized in industrialized countries. giardiasis and cryptosporidium infections in waterborne and other outbreaks have occurred in the united states. parasitic diseases are among the most common causes of illness and death in the world, e.g., malaria. milder illnesses such as giardiasis and trichomoniasis cause widespread morbidity. intestinal infestations with worms may cause of severe complications, although they commonly cause chronic low-grade symptomatology and iron deficiency anemia. echinococcosis (hydatid cyst disease) is infection with echinococcus granulosus, a small dog tapeworm. the tapeworm forms unilocular (single, noncompartmental) cysts in the host, primarily in the liver and lungs, but they can also grow in the kidney, spleen, central nervous system, or in bones. cysts, which may grow up to cm in size, may be asymptomatic or, if untreated, may cause severe symptoms and even death. this parasite is common where dogs are used with herd grazing animals and also have intimate contact with humans. the middle east, greece, sardinia, north africa, and south america are endemic areas, as are a few areas in the united states and canada. the human dis-ease has been eliminated in cyprus and australia. while the dog is the major host, intermediate hosts include sheep, cattle, pigs, horses, moose, and wolves. preventive measures include education in food and animal contact hygiene, destroying wild and stray dogs, and keeping dogs from the viscera of slaughtered animals. a similar, but multilocular, cystic hydatid disease is widely found in wild animal hosts in areas of the northern hemisphere, including central europe, the former soviet union, japan, alaska, canada, and the north-central united states. another echinococcal disease (echinococcus vogeli) is found in south america, where its natural host is the bush dog and its intermediate host is the rat. the domestic dog also serves as a source of human infection. surgical resection is not always successful, and long-term medical treatment may be required. control is through awareness and hygiene as well as the control of wild animals that come in contact with humans and domestic animals. control may require cooperation between neighboring countries. tapeworm infestation (taeniasis) is common in tropical countries where hygienic standards are low. beef (taenia saginata) and pork (t. solium) tapeworms are common where animals are fed with water or food exposed to human feces. freezing or cooking meat will destroy the tapeworm. fish tapeworm (diphyllobothrium latum) is common in populations living primarily on uncooked fish, such as inuit people. these tapeworms are usually associated with northern climates. toddlers are especially susceptible to dog tapeworm (dipylidium caninum), which is present worldwide, and domestic pets are often the source of oral-fecal transmission of the eggs. the disease is usually asymptomatic. similarly, dwarf tapeworm (hymenolepis nana) is transmitted through oral-fecal contamination from person to person, or via contaminated food or water. rat tapeworm (hymenolepis diminuta) also mostly affects young children. onchocerciasis (fiver blindness) is a disease caused by a parasitic worm, which produces millions of larvae that move through the body causing intense itching, debilitation, and eventually blindness. the disease is spread by a blackfly that transmits the larva from infected to uninfected people. it is primarily located in sub-saharan africa and in latin america, with over million persons at risk. control is by a combination of activities including environmental control by larvicidal sprays to reduce the vector population, protection of potential hosts by protective clothing and insect repellents, and case treatment. a who-initiated program for onchocerciasis control started in is sponsored by four international agencies: the food and agriculture organization (fao), the united nations development program (undp), the world bank, and who. it covers countries in sub-saharan africa, focusing on control of the blackfly by destoying its larvae, mainly via insecticides sprayed from the air. prevalence in was reported by who as over million persons. the program has been successful in protecting some million persons and helping . million infected persons to recover from this disease. who estimates that the program will have prevented , cases of blindness by the year and has freed million hectares of land for resettlement and cultivation. the program cost $ million. this investment is considered by the world bank to have a return of - % in terms of large scale land reuse and improved output of the population. a who program, the african program for onchocerciasis control (apoc), started in , uses a new drug (ivermectin) and selective vector control efforts by spraying. this involves countries in africa, and in a similar program in south america. see website http://www/who.int/ocp and is financed by many donor countries, internation organizations, merck & company, and ngos. dracunculiasis (guinea worm disease) is a parasitic disease of great public health importance in india, pakistan, and central and west africa. it is an infection of the subcutaneous and deeper tissues caused by a large ( cm) nematode, usually affecting the lower extremities and causing pain and disability. the nematode causes a burning blister on the skin when it is ready to release its eggs. after the blister ruptures, the worm discharges larvae whenever the extremity is in water. the eggs are ingested in contaminated water and the larva released migrate through the viscera to locate as adults in the subcutaneous tissue of the leg. incubation is about months. the larva released in water are ingested by minute crustaceans and remain infective for as long as a month. prevention is based on improving the safety of water supplies and by preventing contamination by infected persons. education of persons in endemic areas to stay out of water sources and to filter drinking water reduces transmission. insecticides remove the crustaceans. chlorine also kills the larvae and the crustaceans which prologue larval infectivity. there is no vaccine. treatment is helpful, but not definitive. dracunculiasis was traditionally endemic in a belt from west africa through the middle east to india and central asia. it was successfully eliminated from central asia and iran and has disappeared from the middle east and from some african countries (gambia and guinea). the world health organization has promoted the eradication of dracunculiasis. major progress has been made in this direction. worldwide prevalence is reported to have been reduced from million cases in to million in , , in , and , cases in . eradication was anticipated for the year , and in the who established a commission to monitor and certify eradication in formerly endemic areas. india's reported cases fell from , in to in , and the country was free of transmission in . in , formerly high prevalence countries such as kenya reported no cases in , while chad, senegal, cameroons, yemen, and the central african republic less than cases each. eradication of this disease appears to be imminent. the who eradication program was developed successfully as an independent program with its own direction and field staff, but further progress will require the integration of this program with other basic primary care programs in order to be self-sustaining as an integral part of community health. community-based surveillance systems for this disease are being converted to work for monitoring of other health conditions in the community. schistosomiasis (snail fever or bilharziasis) is a parasitic infection caused by the trematode (blood fluke) and transmitted from person to person via an intermediate host, the snail. it is endemic in countries in africa, south america, the caribbean, and asia. there are an estimated million persons infected worldwide and more than million at risk for the disease. the clinical symptoms include fever, nausea, vomiting, abdominal pain, diarrhea, and hematuria. the organisms schistosoma mansoni and s. japonicum cause intestinal and hepatic symptoms, including diarrhea and abdominal pain. schistosoma haematobium affects the genitourinary tract, causing chronic cystitis, pyelonephritis, with high risk for bladder cancer the ninth most common cause of cancer deaths globally. infection is acquired by skin contact with freshwater containing contaminated snails. the cercariae of the organism penetrate the skin, and in the human host it matures into an adult worm that mates and produces eggs. the eggs are disseminated to other parts of the body from the worm's location in the veins surrounding the bladder or the intestines, and may result in neurological symptoms. eggs may be detected under microscopic examination of urine and stools. sensitive serologic tests are also available. treatment is effective against all three major species of schistosomiasis. eradication of the disease can be achieved with the use of irrigation canals, prevention of contamination of water sources by urine and feces of infected persons, treatment of infected persons, destruction of snails, and health education in affected areas. persons exposed to freshwater lakes, streams, and rivers in endemic areas should be warned of the danger of infection. mass chemotherapy in communities at risk and improved water and sanitation facilities are resulting in improved control of this disease. leishmaniasis causes both cutaneous and visceral disease. the cutaneous form is a chronic ulcer of the skin, called by various names, e.g., rose of jericho, oriental sore, and aleppo boil. it is caused by leishmania tropica, l. brasiliensis, l. mexicana, or the l. donovani complex. this chronic ulcer may last from weeks to more than a year. diagnosis is by biopsy, culture, and serologic tests. the organism multiplies in the gut of sandflies (phlebotomus and lutzomi) and is transmitted to humans, dogs, and rodents through bites. the parasites may remain in the untreated lesion for - months, and the lesion does not heal until the parasites are eliminated. prevention is through limiting exposure to the phlebotomines and reducing the sandfly population by environmental control measures. insecticide use near breeding places and homes has been successful in destroying the vector sandflies in their breeding places. case detection and treatment reduce the incidence of new cases. there is no vaccine, and treatment is with specific antimonials and antibiotics. visceral leishmaniasis (kala azar) is a chronic systemic disease in which the parasite multiplies in the cells of the host's visceral organs. the disease is characterized by fever, the enlargement of the liver and spleen, lymphadenopathy, anemia, leukopenia, and progressive weakness and emaciation. diagnosis is by culture of the organism from biopsy or aspirated material, or by demonstration of intracellular (leishman-donovan) bodies in stained smears from bone marrow, spleen, liver, or blood. kala azar is a rural disease occurring in the indian subcontinent, china, the southern republics of the former u.s.s.r., the middle east, latin america, and sub-saharan africa. it usually occurs as scattered cases among infants, children, and adolescents. transmission is by the bite of the infected sandfly with an incubation period of - months. there is no vaccine, but specific treatment is effective and environmental control measures reduce the disease prevalence. this includes the use of antimalarial insecticides. in localities where the dog population has been reduced, the disease is less prevalent. sleeping sickness. sleeping sickness a disease caused by trypanosoma brucei, transmitted but the tsetse fly, primarily in the african savannahs, affecting cattle and humans. some million persons are at risk in sub-saharan africa. who reported , new cases, a total prevalence of , cases, and , deaths from this disease in . prevention depends on vector control, and effective treatment of human cases. chagas disease is a chronic and incurable vector and blood transfusion borne parasitic disease (trypanosoma cruzi) which causes disability and death. it affects some million persons mainly in latin america, with some , new cases and , deaths occurring annually. about % of affected persons develop severe heart disease. brazil, which accounts for % of the cases prevalent in latin america, achieved elimination of transmission in , after uruguay ( ) and venezuela ( ) and followed by argentina ( ) . elimination of transmission is projected by who by the year . control is difficult, but control measures include reducing the animal host and vector insect population in its habitat by ecological and insectiside measures, education of the population in prevention by clothing, bednets, and repellents, and with chemotherapy for case management. amebiasis. amebiasis is an infection with a protozoan parasite (entamoeba histolytica) which exists as an infective cyst. infestation may be asymptomatic or cause acute, severe diarrhea with blood and mucus, alternating with constipation. amebic colitis can be confused with ulcerative colitis. diagnosis is by microscopic examination of fresh fecal specimens showing trophozoites or cysts. transmission is generally via ingestion of fecal-contaminated food or water containing cysts, or by oral-anal sexual practices. amebiasis is found worldwide. sand filtration of community water supplies removes nearly all cysts. suspect water should be boiled. education regarding hygienic practices with safe food and water handling and disposal of human feces are the basis for control. ascariasis. ascariasis is infestation of the small intestine with the roundworm ascaris lumbricoides, which may appear in the stool, occasionally the nose or mouth, or may be coughed up from lung infestation. the roundworm is very common in tropical countries, where infestation may reach or exceed % of the population. children aged - years are especially susceptible. infestation can cause pulmonary symptoms and frequently contributes to malnutrition, especially iron deficiency anemia. transmission is by ingestion of infective eggs, common among children playing in contaminated areas, or via the ingestion of uncooked products of infected soil. eggs may remain viable in the soil for years. vermox and other treatments are effective. prevention is through education, adequate sanitary facilities for excretion, and improved hygienic practices, especially with food. use of human feces for fertilizer, even after partial treatment, may spread the infestation. mass treatment is indicated in high prevalence communities. pinworm disease or enterobiasis. pinworm disease (oxyuriasis) is common worldwide in all socioeconomic classes; however, it is more widespread when crowded and unsanitary living conditions exist. the enterobius vermicularis infestation of the intestine may be symptomless or may cause severe perianal itching or vulvovaginitis. it primarily affects schoolchildren and preschoolers. more severe complications may occur. adult worms may be seen visually or identified by microscopic examination of stool specimens or perianal swabs. transmission is by the oral-fecal ingestion of eggs. the larvae grow in the small intestine and upper colon. prevention is by educating the public regarding hygiene and adequate sanitary facilities, as well as by treating cases and investigating contacts. treatment is the same as for ascariasis. mass treatment is indicated in high prevalence communities. ectoparasites. ectoparasites include scabies (sarcoptes scabiei), the common bed bug (cimex lectularius), fleas, and lice, including the body louse (pediculus humanis), pubic louse (phthirius pubis), and the head louse (pediculus humanus capitis). their severity ranges from nuisance value to serious public health hazard. head lice are common in schoolchildren worldwide and are mainly a distressing nuisance. the body louse serves as a vector for epidemic typhus, trench fever, and louse-borne relapsing fever. in disaster situations, disinfection and hygienic practices may be essential to prevent epidemic typhus. the flea plays an important role in the spread of the plague by transmitting the organism from the rat to humans. control of rats has reduced the flea population, but during war and disasters, rat and flea populations may thrive. scabies, which is caused by a mite, is common worldwide and is transmitted from person to person. the mite burrows under the skin and causes intense itching. all of these ectoparasites are preventable by proper hygiene and the treatment of cases. the spread of these diseases is rapid and therefore warrants attention in school health and public health policy. legionnelae, a gram-negative group of bacilli, with species and many serogroups. the first documented case was reported in the united states in , and the first disease outbreak was reported in the united states in among participants of a war veterans convention. general malaise, anorexia, myalgia, and headache are followed by fever, cough, abdominal pain, and diarrhea. pneumonia followed by respiratory failure may follow. the case fatality rate can be as high as % of hospitalized cases. a milder, nonpneumonic form of the disease (pontiac fever) is associated with virtually no mortality. the organism is found in water reservoirs and is transmitted through heating, cooling, and air conditioning systems, as well as from tap water, showers, saunas, and jaccuzzi baths. the disease has been reported in australia, canada, south america, europe, israel, and on cruise ships. prevention requires the cleaning of water towers and cooling systems, including whirlpool spas. hyperchlorination of water systems and the replacement of filters is required where cases and/or organisms have been identified. antibiotic treatment with erythromycin is effective. leprosy (hansen's disease) was widely prevalent in europe and mediterranean countries for many centuries, with some , leprosaria in the year . leprosy was largely wiped out during the black death in the fourteenth century, but continued in endemic form until the twentieth century. leprosy is a chronic bacterial infection of the skin, peripheral nerves, and upper airway. in the lepromatous form, there is diffuse infiltration of the skin nodules and macules, usually bilateral and extensive. the tuberculoid form of the disease is characterized by clearly demarcated skin lesions with peripheral nerve involvement. diagnosis is based on clinical examination of the skin and signs of peripheral nerve damage, skin scrapings, and skin biopsy. transmission of the mycobacterium leprae organism is by close contact from person to person, with incubation periods of between months and years (average of - years). rifampicin and other medications make the patient noninfectious in a short time, so that ambulatory treatment is possible. multidrug therapy (mdt) has been shown to be highly effective in combating the disease, with a very low relapse rate. treatment with mdt ensures that the bacillus does not develop drug resistance. mdt is covering % of known cases in , according to who reports, as compared to only % in . the increase has been associated with improved case finding. bcg may be useful in reducing tuberculoid leprosy among contacts. investigation of contacts over years is recommended. the disease is still highly endemic primarily in five countries, india, brazil, indonesia, myanmar, and bangladesh, and is still present in some countries in southeast asia, including the philippines and burma, sub-saharan africa, the middle east (sudan, egypt, iran), and in some parts of latin america (mexico, colombia) with isolated cases in the united states. world prevalence has declined from . million cases in , . million in , to less than million cases in . the world health organization expects to eliminate leprosy as a public health problem by the year , defined as prevalence of less than per , population, or less than , cases. trachoma is currently responsible for million blind persons or % of total blindness in the world. the causative organism, chlamydia trachomatis, is a bacteria which can survive only within a cell. it is spread through contact with eye discharges, usually by flies, or household items (e.g., handkerchiefs, washcloths). trachoma is common in poor rural areas of central america, brazil, africa, parts of asia, and some countries in the eastern mediterranean. the resulting infection leads to conjuncfival scarring and if untreated, to blindness. who estimates there are million cases of active disease in endemic countries. hygiene, vector control, and treatment with antibiotic eye ointments or simple surgery for scarring of eyelids and inturned eyelashes prevent the blindness. a new drug, azithromycin, is effective in curing the disease. the who is promoting a program for the global elimination of trachoma using azithromycin and hygiene education in endemic areas. chlamydia (chlamydia pneumonia) is suspected of playing a role in coronary artery disease by intraarterial infection, with plaque formation and occlusion of the artery by thrombi consisting mainly of platelets. if borne out, this will provide potential for low cost intervention to reduce the burden of the leading worldwide cause of death. sexually transmitted diseases (stds) are widespread internationally with an estimated million new cases per year, with . million new cases, over million total cases, and . million deaths ( ), aids has captured world attention over the past decade. the global burden of stds is enormous (table . ), and the public health and social consequences are devastating in many countries. sexually transmitted diseases, especially in women, may be asymptomatic, so that severe sequelae may occur before patients seek care. infection by one std increases risk of infection by other diseases in this group. syphilis is caused by the spirochete treponema pallidum. after an incubation period of - days (mean - ), primary syphilis develops as a painless ulcer or chancre on the penis, cervix, nose, mouth, or anus, lasting - weeks. the patient may first present with secondary syphilis - weeks (up to weeks) after infection with a general rash and malaise, fever, hair loss, arthritis, and jaundice. these symptoms spontaneously disappear within weeks or up to months later. tertiary syphilis may appear - years after initial infection. complications of tertiary syphilis include catastrophic cardiovascular and central nervous system conditions. early antibiotic treatment is highly effective when given in a large initial dose, but longer term therapy may be needed if treatment is delayed. gonorrhea (gc) is caused by the bacterium neisseria gonorrhoeae. the incubation period is - days. gonorrhea is often associated with concurrent chlamydia infection. in women, gc may be asymptomatic or it may cause vaginal discharge, pain on urination, bleeding on intercourse, or lower abdominal pain. untreated, it can lead to sterility. in men, gc causes urethral discharge and painful urination. treatment with antibiotics ends infectivity, but untreated cases can be infectious for months. drug resistance to penicillin and tetracycline has increased in many countries so that more expensive and often unavailable drugs are necessary for treatment. prevention of gonococcal eye infection in newborns is based on routine use of antibiotic ointments in the eyes of newborns. chancroid. chancroid is caused by haemophilus ducreyi. in women chancroids may cause a painful, irregular ulcer near the vagina, resulting in pain on in-tercourse, urination, and defection, but it may be asymptomatic. in men it causes a painful, irregular ulcer on the penis. the incubation period is usually - days, but may be up to days. an individual is infectious as long as there are ulcers, usually - months. treatment is by erythromycin or azithromycin. herpes simplex. herpes simplex is caused by herpes simplex virus types and and has an incubation period of - days. genital herpes causes painful blisters around the mouth, vagina, penis, or anus. the genital lesions are infectious for - days. herpes may lead to central nervous system meningoencephalitis infection. it can be transmitted to newborns during vaginal delivery, causing infection, encephalitis, and death. cesarian delivery is therefore necessary when a mother is infected. anti-viral drugs are used in treatment, orally, topically, or intravenously. chlamydia. chlamydia is caused by chlamydia trachomatis. in women, it is usually asymptomatic but may cause vaginal discharge, spotting, pain on urination, lower abdominal pain, and pelvic inflammatory disease (pid). in newborns, chlamydia may cause eye and respiratory infections. in men, chlamydia causes urethral discharge and pain on urination. the incubation period is - days and the infectious period is unknown. treatment for chlamydia is doxycycline, azithromycin, or erythromycin. chlamydia infection, not necessarily venereal in transmission, may be transmitted to newborns of infected mothers. chlamydia pneumoniae, presently under investigation as a possible cause or contributor to coronary heart disease, and is widespread in poor hygenic conditions. trichomoniasis. trichomoniasis is caused by trichomonas vaginalis. the incubation period is - days (mean = ). in women, trichomoniasis may be asymptomatic or may cause a frothy vaginal discharge with foul odor, and painful urination and intercourse. in men, the disease is usually mild, causing pain on urination. treatment is by metronidazole taken orally. without treatment, the disease may persist and remain infectious for years. (hpv). it is a sporadic disease which may be associated with cervical neoplasia and cancer of the cervix. hpv includes many types associated with a variety of conditons. the search for a hpv vaccine to prevent cancer of the cervix looks promising. in areas where a full range of diagnostic services is lacking, a "syndromic approach" is recommended for the control of stds. the diagnosis is based on a group of symptoms and treatment on a protocol addressing all the diseases that could possibly cause those symptoms, without expensive laboratory tests and repeated visits. early treatment without laboratory confirmation helps to cure persons who might not return for follow-up, or may place them in a noninfective stage so that even without follow-up they will not transmit the disease. std incidence between and is shown in table . , with decline overall except around , with subsequent further fall in incidence. screening in prenatal and family planning clinics, prison medical services, and selected years - disease syphilis ( [ ] [ ] [ ] [ ] [ ] [ ] and subsequent decline by more than % in reported cases includes all three stages of the disease as well as congential syphilis. rates are cases per , population, rounded. in clinics serving prostitutes, homosexuals, or other potential risk groups will detect subclinical cases of various stds. treatment can be carried out cheaply and immediately. for instance, the screening test for syphilis costs $ . and the treatment with benzathine penicillin injection costs about $ . in . partner notification is a controversial issue, but may be needed to identify contacts who may be the source of transmission to others. control of stds through a syndrome approaach based on primary care providers is being promoted by who. health education directed at high risk target groups is essential. providing easy and cost-free access to acceptable, nonthreatening treatment is vital in promoting the early treatment of cases and thereby reducing the risk of transmission. promoting prevention through the use of condoms and/or monogamy requires long-term educational efforts that are now fostered by the hiv/aids pandemic. increased use of condoms for hiv prevention is associated with reduced risk of other stds. training medical care providers in std awareness should be stressed in undergraduate and continuing educational efforts including personal protection as care givers. human immunodeficiency virus (hiv) is a retrovirus that infects various cells of the immune system, and also affects the central nervous system. two types have been identified: hiv , worldwide in distribution, and the less pathogenic hiv , found mainly in west africa. hiv is transmitted by sexual contact, exposure to blood and blood products, perinatally, and via breast milk. the period of communicability is unknown, but studies indicate that infectiousness is high, both during the initial period after infection and later in the disease. antibodies to hiv usually appear within - months. within several weeks to months of the infection, many persons develop an acute self-limited flulike syndrome. they may then be free of any signs or symptoms for months to more than years. onset of illness is usually insidious with nonspecific symptoms, including sweats, diarrhea, weight loss, and fatigue. aids represents the later clinical stage of hiv infection. according to the revised cdc case definition ( ), aids involves any one or more of the following: low cd count, severe systematic symptoms, opportunistic infections such as pneumocystis pneumonia or tb, aggressive cancers such as kaposi's sarcoma or lymphoma, and/or neurological manifestations, including dementia and neuropathy. the who case definition is more clinically oriented, relying less on often unavailable laboratory diagnoses for indicator diseases. aids was first recognized clinically in in los angeles and new york. by mid- it was considered an epidemic in those and other u.s. cities. it was primarily seen among homosexual men and recipients of blood products. after initial errors, testing of blood and blood products became standard and has subsequently closed off this method of transmission. transmission has changed markedly since the initial onslaught of the disease, with needle sharing among intravenous drug users, heterosexual, and maternal-fetal transmission becoming major factors. comorbidity with other stds apparently increases hiv infectivity and may have helped to convert the epidemiology to a greater degree of heterosexual transmission. the disease grew exponentially in the united states (table . ), but incidence of new cases nas declined since . aids has become a major public health problem in most developed and developing countries, reaching catastrophic proportions in some sub-saharan african countries affecting up to % of the population. hiv-related deaths were the eighth leading cause of all deaths in in the u.s., the leading cause among men aged - years of age, and the fourth leading cause for women in this age group. by , aids had been diagnosed in , persons and , had died. it is estimated that up to million persons are hiv infected in the united states. globally, deaths from aids totalled . million in , with an estimated . million person having died from this pandemic up to . in , an estimated . million person were hiv infected with . million new infection in . the declining incidence of new cases in the industrialized countries may be the result of greater awareness of the disease and methods of prevention of transmission. improving early diagnosis and access to care, especially the combined therapy programs that are very effective in delaying onset of symptoms, are important parts of public health management of the aids crisis. until an effective vaccine is available, preventive reliance will continue to be on behavior risk-reduction and other prevention strategies such as needle and condom distribution among high risk population groups. throughout the world, hiv continues to spread rapidly, especially in poor countries in africa, asia, and south and central america. the united nations reports that million persons are living with hiv/aids, % of them in developing countries, where transmission is % by heterosexual contact. every day, more than persons are infected, including children. in thailand, person in is now infected. in sub-saharan africa person in is infected, and in some cities as many as person in carries the virus. estimations of new infections per year in sub-saharan africa range from to million persons, while in asia the range is from . to . million new infected persons per year. lessons are still being learned from the aids pandemic. the explosive spread of this infection, from an estimated , people in to an anticipated million persons hiv infected, shows that the world is still vulnerable to pandemics of "new" infectious diseases. enormous movements of tourists, business people, truck drivers, migrants, soldiers, and refugees promote the spread of such diseases. widespread sexual exchange, traffic in blood products, and illicit drug use all promote the international potential for pandemics. war and massive refugee situations promote rape and prostitution, worsening the aids situation in some settings in africa. hiv has arrived in almost every country. however, there is the somewhat hopeful indication that the rate of increase, has slowed in the united states. this may be an indication either of higher levels of self-protective behavior, or that the most susceptible population groups have already been affected and the spread into the general population is at a slower rate. it is also possible that this may yet prove to be only a lull in the storm, as heterosexual contact becomes a more important mode of transmission. the eleventh international conference on aids, held in vancouver, canada, in july , reported signs that combinations of several drugs from among a number of antiretroviral medications are showing promise to suppress the aids virus in infected people. at a current annual price of $ , - , per patient, these sums well beyond the capacity of most developing countries. development of methods of measuring the hiv viral load have allowed for better evaluation of potential therapies and monitoring of patients receiving therapy. in developed countries, transmission by blood products has been largely controlled by screening tests; transmission among homosexuals has been reduced by safe sex practices; transmission to newborns has been reduced by recent therapeutic advances. safe sex practices and condom use may have helped in reducing heterosexual transmission. further advances in therapy and prevention with a vaccine are expected over the next decade. the hiv/aids pandemic is one of the great challenges to public health for the st century due to its complexity, its international spread, its sexual and other modes of transmission, its devastating and costly clinical effects, and its impact on parallel diseases such as tuberculosis, respiratory infections, and cancer. the cost of care for the aids patient can be very high. needed programs include home care and community health workers to improve nutrition and self-care, and mutual help among hiv carriers and aids patients. the ethical issues associated with aids are also complex regarding screening of pregnant women, newborns, partner notification, reporting, and contact tracing, as well as financing the cost of care. diarrheal diseases are caused by a wide variety of bacteria, parasites, and viruses (table . ) infecting the intestinal tract and causing secretion of fluids and dis- solved salts into the gut with mild to severe or fatal complications. in developing countries, diarrheal diseases account for half of all morbidity and a quarter of all mortality. diarrhea itself does not cause death, but the dehydration resulting from fluid and electrolyte loss is one of the most common causes of death in children worldwide. deaths from dehydration can be prevented by use of oral rehydration therapy (ort), an inexpensive and simple method of intervention easily used by a nonmedical primary care worker and by the mother of the child as a home intervention. in , diarrheal diseases were the cause of almost million child deaths, but by this had declined to . million, largely under the impact of increased use of ort. diarrheal diseases are transmitted by water, food, and directly from person to person via oral-fecal contamination. diarrheal diseases occur in epidemics in situations of food poisoning or contaminated water sources, but can also be present at high levels when common source contamination is not found. contamination of drinking water by sewage and poor management of water supplies are also major causes of diarrheal disease. the use of sewage for the irrigation of vegetables is a common cause of diarrheal disease in many areas. salmonella are a group of bacterial organisms causing acute gastroenteritis, associated with generalized illness including headache, fever, abdominal pains, and dehydration. there are over serotypes of salmonella, many of which are pathogenic in humans, the most common of which are salmonella typhimurium, s. enteritidis, and s. typhi. transmission is by ingestion of the organisms in food, derived from fecal material from animal or human contamination. common sources include raw or uncooked eggs, raw milk, meat, poultry and its products, as well as pet turtles or chicks. fecal-oral transmission from person to person is common. prevention is in safe animal and food handling, refrigeration, sanitary preparation and storage, protection against rodent and insect contamination, and the use of sterile techniques during patient care. antibiotics may not eliminate the carrier state and may produce resistant strains. shigella are a group of bacteria that are pathogenic in man, with four groups: type a = shigella dysenteriae, type b = s. flexneri, type c = s. boydii, and type d = s. sonnei. types a, b, and c are each further divided into a total of serotypes. shigella are transmitted by direct or indirect fecal-oral methods from a patient or carrier, and illness follows ingestion of even a few organisms. water and milk transmission occurs as a result of contamination. flies can transmit the organism, and in nonrefrigerated foods the organism may multiply to an infectious dose. control is in hygienic practices and in the safe handling of water and food. escheria eoli e. coli are common fecal contaminants of inadequately prepared and cooked food. particularly virulent strains such as o :h can cause explosive outbreaks of severe (enterohemmorhagic) diarrhoeal disease with a hemolytic-uremic syndrome and death, as occurred in japan in with cases and deaths due to a foodborne epidemic. other milder strains cause travellers diarrhoea and nursery infections. inadequately cooked hamburger, unpasturized milk, and other food vectors are discussed under food safety in chapter . cholera is an acute bacterial enteric disease caused by vibrio cholerae, with sudden onset, profuse painless watery stools, occasional vomiting, and, if untreated, rapid dehydration, and circulatory collapse, and death. asymptomatic infection or carrier status, and mild cases are common. in severe, untreated cases, mortality is over %, but with adequate treatment, mortality is under %. diagnosis is based on clinical signs, epidemiologic, serologic and bacteriologic confirmation by culture. the two types of cholera are the classic and el tor (with inaba and ogawa serotypes). in , a large scale epidemic of cholera spread through much of south america. it was imported via a chinese freighter, whose sewage contaminated shellfish in lima harbor in peru (box . ). the south american cholera epidemic has caused hundreds of thousands of cases and thousands of deaths since . prevention requires sanitation, particularly the chlorination of drinking water, prohibiting the use of raw sewage for the irrigation of vegetable crops, and high standards of community, food, and personal hygiene. treatment is prompt fluid therapy with electrolytes in large volume to replace all fluid loss. oral rehydration should be accomplished using standard ort. tetracycline shortens the duration of the disease, and chemoprophylaxis for contacts following stool samples may help in reducing its spread. a vaccine is available but is of no value in the prevention of outbreaks. viral gastroenteritis can occur in sporadic or epidemic forms, in infants, children, or adults. some viruses, such as the rotaviruses and enteric adenoviruses, af- in the s, peruvian officials stopped the chlorination of community water supplies because of concern over possible carcinogenic effects of trihalomethanes, a view encouraged by officials of the u.s. environmental protection agency (epa) and the u.s. public health service. in january , a chinese freighter arrived in lima, peru, and dumped bilge (sewage) in the harbor, apparently contaminating local shellfish. consumption of raw shellfish is a popular local delicacy (ceviche) and associated with cases of cholera seen in local hospitals. contamination of local water supplies from sewage resulted in the geometric increase in cases, and by the end of the pan american health organization (paho) reported an epidemic of , cases and deaths. the epidemic spread to countries, and in there were a further , cases and deaths spreading over much of south america, continuing in . in the united states, cases of cholera were reported in ; of these, cases and death were among passengers of an airplane flying from south america to los angeles in which contaminated seafood was served. in , cases of cholera were reported in the united states which were unrelated to international travel. these occurred mostly among persons consuming shellfish from the gulf coast with a strain of cholera similar to the south american strain, also possibly introduced in ship ballast. cholera organisms are reported in harbor waters in other parts of the united states (promed, , promed, . fect mainly infants and young children, and may be severe enough to cause hospitalization for dehydration. others such as norwalk and norwalk-like viruses affect older children and adults in self-limited acute gastroenteritis in family, institution, or community outbreaks. rotaviruses cause acute gastroenteritis in infants and young children, with fever and vomiting, followed by watery diarrhea and occasionally severe dehydration and death if not adequately treated. diagnosis is by examination of stool or rectal swabs with commercial immunologic kits. in both developed and developing countries, rotavirus is the cause of about one-third of all hospitalized cases for diarrheal diseases in infants and children up to age . most children in developing countries experience this disease by the age of years, with the majority of cases between and months. in developing countries, rotaviruses are estimated to cause over , deaths per year. the virus is found in temperate climates in the cooler months and in tropical countries throughout the year. breastfeeding does not prevent the disease but may reduce its severity. oral rehydration therapy is the key treatment. a live attenuated vaccine was approved by the fda in and adopted in the u.s. recommended routine vaccination programs for infants. adenoviruses. adenoviruses, norwalk, and a variety of other viruses (including astrovirus, calcivirus, and other groups) cause sporadic acute gastroenteritis worldwide, mostly in outbreaks. spread is by the oral-fecal route, often in hospital or other communal settings, with secondary spread among family contacts. food-borne and waterborne transmission are both likely. these can be a serious problem in disaster situations. no vaccines are available. management is with fluid replacement and hygienic measures to prevent secondary spread. giardiasis. giardiasis (caused by giardia lamblia) is a protozoan parasitic infection of the upper small intestine, usually asymptomatic, but sometimes associated with chronic diarrhea, abdominal cramps, bloating, frequent loose greasy stools, fatigue, and weight loss. malabsorption of fats and vitamins may lead to malnutrition. diagnosis is by the presence of cysts or other forms of the organism in stools, duodenal fluid, or in intestinal mucosa from a biopsy. this disease is prevalent worldwide and affects mostly children. it is spread in areas of poor sanitation and in preschool settings and swimming pools, and is of increasing importance as a secondary infection among immunocompromised patients, especially those with aids. waterborne giardia was recognized as a serious problem in the united states in the s and s, since the protozoa is not readily inactivated by chlorine, but requires adequate filtration before chlorination. person-to-person transmission in day-care centers is common, as is transmission by unfiltered stream or lake water where contamination by human or animal feces is to be expected. an asymptomatic carrier state is common. prevention relies on careful hygiene in settings such as day-care centers, filtration of public water supplies and the boiling of water in emergency situations. cryptosporidium. cryptosporidium parvum is a parasitic infection of the gastrointestinal tract in man, small and large mammals and vertebrates. infection may be asymptomatic or cause a profuse, watery diarrhea, abdominal cramps, general malaise, fever, anorexia, nausea, and vomiting. in immunosuppressed patients, such as persons with aids, it can be a serious problem. the disease is most common in children under years of age and those in close contact with them, as well as in homosexual men. diagnosis is by identification of the cryptosporidium or-ganism cysts in stools. the disease is present worldwide. in europe and the united states, the organism has been found in < to . % of individuals sampled. spread is common by person-to-person contact by fecal-oral contamination, especially in such settings as day-care centers. raw milk and waterborne outbreaks have also been identified in recent years. a large waterborne disease outbreak due to cryptosporidium occurred in milwaukee in described in chapter . management is by rehydration and prevention is by careful hygiene in food and water safety. helicobacter pylori. helicobacter pylori, first identified in , is a bacterium causally linked to duodenal ulcers and gastritis, contributing to high rates of gastric cancer (chapter ). it is an important example of the link between infection and chronic disease. this has enormous implications for prevention of cancer of the stomach, chronic peptic ulcers and large-scale use of hospitals and other medical resources (see chapter ). the control of diarrheal diseases requires a comprehensive program involving a wide range of activities, including good management of food and water supplies, education in hygiene, and, particularly where morbidity and mortality are high, education in the use of oral rehydration therapy (ort). oral rehydration therapy (ort) is considered by unicef and who to have resulted in the saving of million lives each year in the s. proper management of an episode of diarrhea by ort (table . ), along with continued feeding, not only saves the child from dehydration and immediate death, but also contributes to early restoration of nutritional adequacy, sparing the child the prolonged effects of malnutrition. the world summit for children (wsc) in called for a reduction in child deaths from diarrheal diseases by one-third and malnutrition by one-half, with em- phasis on the widest possible availability, education for, and use of ort. this requires a programmatic approach. public health leadership must train primary care doctors, pediatricians, pharmacists, drug manufacturers, and primary care health workers of all kinds in ort principles and usage. they must be backed by the widest possible publicity to raise awareness among parents. oral rehydration therapy is an important public health modality in developed countries as well as in developing countries. diarrhoeal disease may not cause death as frequently in developed countries, but it is still a significant factor in infant and child health and, even under the most optimal conditions, can cause setbacks in the nutritional state and physical development of a child. use of ort does not prevent the disease (i.e., it is not a primary prevention), but it is excellent in secondary prevention, by preventing complications from diarrhoea, and should be available in every home for symptomatic treatment of diarrheal diseases. an adaptation of ort has found its place in popular culture in the united states. a form of ort, marketed as "sports drinks," is used in sports where athletes lose large quantifies of water and salts in sweat and insensible loss from the respiratory tract. the wider application of the principles of ort for use in adults in dry hot climates and in adults under severe physical exertion with inadequate fluid/salt intake situations requires further exploration. management of diarrheal diseases should be part of a wider approach to child nutrition. the child who goes through an episode of diarrheal disease may have a faltering in growth and development. supportive measures may be needed following the episode as well as during it. this involves providing primary care services that are attuned to monitoring individual infant and child growth. growth monitoring surveillance is important to assess the health status of the individual child and the child population. supplementation of infant feeding with vitamins a and d, and iron to prevent anemia are important for routine infant and child care, and more so for conditions affecting total nutrition such as a diarrheal disease. in the developing world, respiratory infections account for over one-quarter of all deaths and illnesses in children. as diarrheal disease deaths are reduced, the major cause of death among infants in developing countries is becoming acute respiratory infections (aris). in industrialized countries, aris are important for their potentially devastating effects on the elderly and chronically ill. they are also the major cause of morbidity in infants in developed countries, causing much anxiety to parents even in areas with good living conditions. cigarette smoking, chronic bronchitis, poorly controlled diabetes or congestive heart failure, and chronic liver and kidney disease increase susceptibility to aris. aris place a heavy burden on health care systems and individual families. improved methods of management of such chronic diseases are needed to reduce the associated toll of morbidity, mortality, and the considerable expenses of health care. acute respiratory infections are due to a broad range of viral and, to a lesser extent, bacterial infections. it is the latter which can progress to pneumonia with mortality rates of - %. acute viral respiratory diseases include those affecting the upper respiratory tract, such as acute viral rhinitis, pharyngitis, and laryngitis, as well as those affecting the lower respiratory tract, tracheobronchitis, bronchitis, bronchiolitis, and pneumonia. aris are frequently associated with vaccine-preventable diseases, including measles, varicella, and influenza. they are caused by a large number of viruses, producing a wide spectrum of acute respiratory illness. some organisms affect any part of the respiratory tract, while others affect specific parts and all predispose to bacterial secondary infection. while children and the elderly are especially susceptible to morbidity and mortality from acute respiratory disease, the vast numbers of respiratory illnesses among adults cause large-scale economic loss from work absence. bacterial agents causing upper respiratory tract infection include group a streptococcus, mycoplasma pneumonia, pertussis, and parapertussis. pneumonia or acute bacterial infection of the lower respiratory tract and lung tissue may be due to pneumococcal infection with streptococcus pneumoniae. there are known types of this organism, distinguished by capsule characteristics; account for % of pneumococcal infections in the united states. an excellent polyvalent vaccine based on these types is available for high risk groups such as the elderly, immunodeficient patients, and persons with chronic heart, lung, liver, blood disorders, or diabetes. opportunistic infections attack the chronically ill, especially those with compromised immune suystems, often with life-threatening aris. mycoplasma (primary atypical pneumonia) is a lower respiratory tract infection which sometimes progresses to pneumonia. tb and pneumonocytis carynia are especially problematic for aids patients. other organisms causing pneumonias include chlamydia pneumoniae, h. influenza, klebsiella pneumonia, escherichia coli, staphylococcus, rickettsia (q fever), and legionella. parasitic infestation of lungs may occur with nematodes (e.g., ascariasis). fungal infections of the lung may be caused by aspergillosis, histoplasmosis, and coccidiomycosis, often as a complication of antibiotic therapy. access to primary care and early institution of treatment are vital to control excess mortality from aris. in developed countries, aris as contributors to infant deaths are largely a problem in minority and deprived population groups. because these groups contribute disproportionately to childhood mortality, infant mortality reduction has been slower in countries such as the united states and russia than in other industrialized countries. the continuing gap in mortality rates between white and black children in the united states can, to a large extent, be attributed to aris and less access to organized primary care. children are brought to emergency rooms for care when the disease process is already advanced and more dangerous than had it been attended to professionally earlier in the process. many field trials of ari prevention programs have been proved successful involving parent education and training of primary care workers in early assessment and, if necessary, initiation of treatment. this needs field testing in multiple settings. reliance on vaccines to prevent respiratory infectious diseases is not currently feasible. aris are caused by a very wide spectrum of viruses, and the development of vaccines in this field has been slow and limited. the vaccine for pneumococcal pneumonia has been an important breakthrough, but it is still inadequately utilized by the chronically ill because of its limitations, costs, and lack of sufficient awareness, and it is too expensive for developing countries. improvements in bacterial and viral vaccine development will potentially help to reduce the burden of aris. a programmatic approach with clinical guidelines and education of family and care givers is currently the only feasible way to reduce the still enormous morbidity and mortality from aris on the young and the elderly. the success of sanitation vaccines and antibiotics led many to assume that all infectious diseases would sooner or later succumb to public health and medical technology. unfortunately, this is a premature and even dangerous assumption. despite the longstanding availability of an effective and inexpensive vaccine, the persistence of measles as a major killer of million children per year represents a failure in effective use of both the vaccine and the health system. the resurgence of tb and malaria have led to new strategies, such as managed or directly observed care, with community health workers to assure compliance needed to render the patient noninfectious to others and to reduce the pool of carriers of the disease. current successes in reducing poliomyelitis, dracunculiasis, onchocerciasis, and other diseases to the point of eradication has raised hopes for similar success in other fields. but there are many infectious diseases of importance in developed and developing countries where existing technologies are not fully utilized. oral rehydration therapy (ort) is one of the most cost-effective methods of preventing excess mortality from ordinary diarrheal diseases, and yet is not used on sufficient scale. biases in the financing and management of medical insurance programs can result in underutilization of available effective vaccines. hospital-based infections cause large-scale increases in lengths of stay and expenditures, although application of epidemiologic investigation and improved quality in hospital practices could reduce this burden. control of the spread of aids using combined medical therapies is not financially or logistically possible in many countries, but education for "safe sex" is effective. community health worker programs can greatly enhance tuberculosis, malaria, and std control, or in aids care, promote prevention and appropriate treatment. in the industrialized and mid-level developing countries, epidemiologic and demographic shifts have created new challenges in infectious disease control. prevention and early treatment of infectious disease among the chronically ill and the elderly is not only a medical issue, it is also an economic one. patients with chronic obstructive lung disease (copd), chronic liver or kidney disease, or congestive heart failure are at high risk of developing an infectious disease followed by prolonged hospitalization. public health has addressed, and will continue to stress the issues of communicable disease as one of its key issues in protecting individual and population health. methods of intervention include classic public health through sanitation, immunization, and well beyond that into nutrition, education, case finding, and treatment, and changing human behavior. the knowledge, attitudes, beliefs, and practices of policy makers, health care providers, and parents is as important in the success of communicable disease control as are the technology available and methods of financing health systems. together, these encompass the broad programmatic approach of the new public health to control of communicable diseases. in a world of rapid international transport and contact between populations, systems are needed to monitor the potential explosive spread of pathogens that may be transferred from their normal habitat. the potential for the international spread of new or reinvigorated infectious diseases constitute threat to mankind akin to ecological and other man-made disasters. the eradication of smallpox paved the way for the eradication of poliomyelitis, and perhaps measles, in the foreseeable future. new vaccines are showing the capacity to reduce important morbidity from rubella syndrome, mumps, meningitis, and hepatitis. other new vaccines on the horizon will continue the immunologic revolution into the twenty-first century. as the triumphs of control or elimination of infectious diseases of children continue, the scourge of hiv infection continues with distressingly slow progess an effective vaccine or cure for the disease it engenders. partly as a result of the hiv/ aids, tb staged a comeback in many countries where it was thought to be merely a residual problem. at the same time an old/new method of intervention using directly observed short-term therapy has shown great success in controlling the tb epidemic. the resurgence of tb is more dangerous in that mdrtb has become a widespread problem. this issue highlights the difficulty of keeping ahead of drug resistance in the search for new generations of antibiotics, posing a difficult challenge for the pharmaceutical industry, basic scientists as well as public health workers. the burden of infectious diseases has receded as the predominant public health problem in the developed countries but remains large in the developing countries. with increases in longevity and increased importance of chronic disease in the health status of the industrial and mid-level developing nations, the effects of infectious disease on the care of the elderly and chronically ill is of great importance in the new public health. long-term management of chronic disease needs to address the care of vulnerable groups, promoting the use of existing vaccines and antibiotics. most important is the development of health systems that provide close monitoring of groups at special risk for infectious disease, especially patients with chronic diseases, the immunocompromised, and the elderly. the combination of traditional public health with direct medical care needed for effective control and eradication of communicable diseases is an essential element of the new public health. the challenge is to apply a comprehensive approach and management of resources to define and reach achievable targets in communicable disease control. access to e-mail and the internet are vital to current practice of public health and nowhere is this more important than in communicable diseases. there are many such information sites and these will undoubtedly expand in the coming years. several sites are given as examples. the internet has great practical implications for keeping up to date with rapidly occurring events in this field. outstanding encyclopedia database on infectious diseases (available via mdcassoc@ix.netcom.com at reduced price for promed users, and free to sub-saharan african sites) promed is an excellent, free report on current events in communicable diseases internationally; join via owner-promed @usa recommended readings centers for disease control. . update: international task force for disease eradication addressing emerging infectious disease threats: a prevention strategy for the united states. executive summary update: trends in aids incidence--united states one thousand days until the target date for global poliomyelitis eradication tuberculosis morbidity--united states measles--united states, . morbidity and mortality weekly report national adult immunization awareness week--october - , recommended readings ; and influenza and pneumococcal vaccination levels among adults aged --- years impact of the sequential ipv/opv schedule on vaccination cover-agemunited states advances in global measles control and elimination: summary of the international meeting recommended childhood immunization schedulemunited states impact of vaccines universally recommended for childrenmunited states progress toward global poliomyelitis eradication global disease elimination and eradication as public health strategies childhood immunizations rotavirus vaccines: who position paper. weekly epidemiologic record infectious diseases of humans: dynamic and control vaccines and world health: science, policy, and practice control of communicable diseases manual jawetz, melnick and adelberg's medical microbiology, twenty-first edition preventive medicine and public health, second edition efficacy of bcg vaccine in the prevention of tuberculosis. meta-analysis of the published literature manson's tropical diseases vaccination and world health principles and practice oflnfectious diseases immunization of adolescents: recommendations of the advisory committee on immunization practices, the american academy of pediatrics, the american academy of family physicians and the combination vaccines for childhood immunization: recommendations of the advisory committee on immunization practices, the american academy of pediatrics, the american academy of family physicians and the poliomyelitis prevention: revised recommendations for use of inactivated and live oral poliovirus vaccines diphtheria outbreakmrussian federation rubella and congenital rubella syndrome~united states compendium of animal rabies control, : national association of state public health veterinarians progress toward elimination of haemophilus influenzae type b disease among infants and children in the united states tetanus surveillance~united states, - recommendations and reports--vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of measles: recommendations of the advisory committee on immunization practices national, state and urban area vaccination coverage levels among children aged - months~united sates varicella related deaths among children--united states progress toward global poliomyelitis eradication ten great public health achievements--united states a ten-year experience in control of poliomyelitis through a combination of live and killed vaccines in two developing areas measles control in developing and developed countries: the case for a two-dose policy integration of vitamin a supplementation with immunization. weekly epidemiological record update cholera--western hemisphere, . morbidity and mortality weekly 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drugs in the management of acute diarrhoea in children world health organization. . the malaria situation in aids: images of the epidemic. geneva: who. world health organization progress toward the elimination of leprosy as a public health problem the world health report : fighting disease, fostering development the world health report health for all in the twenty-first century. eb / . geneva: who. world health organization. . the world health report : life in the twenty-first century: a vision for all world health organization. . the world health report : making a difference key: cord- - q nxte authors: bouza, emilio; brenes, francisco josé; domingo, javier díez; bouza, josé maría eiros; gonzález, josé; gracia, diego; gonzález, ricardo juárez; muñoz, patricia; torregrossa, roberto petidier; casado, josé manuel ribera; cordero, primitivo ramos; rovira, eduardo rodríguez; torralba, maría eva sáez; rexach, josé antonio serra; garcía, javier tovar; bravo, carlos verdejo; palomo, esteban title: the situation of infection in the elderly in spain: a multidisciplinary opinion document date: - - journal: rev esp quimioter doi: . /req/ . sha: doc_id: cord_uid: q nxte infection in the elderly is a huge issue whose treatment usually has partial and specific approaches. it is, moreover, one of the areas where intervention can have the most success in improving the quality of life of older patients. in an attempt to give the widest possible focus to this issue, the health sciences foundation has convened experts from different areas to produce this position paper on infection in the elderly, so as to compare the opinions of expert doctors and nurses, pharmacists, journalists, representatives of elderly associations and concluding with the ethical aspects raised by the issue. the format is that of discussion of a series of pre-formulated questions that were discussed by all those present. we begin by discussing the concept of the elderly, the reasons for their predisposition to infection, the most frequent infections and their causes, and the workload and economic burden they place on society. we also considered whether we had the data to estimate the proportion of these infections that could be reduced by specific programmes, including vaccination programmes. in this context, the limited presence of this issue in the media, the position of scientific societies and patient associations on the issue and the ethical aspects raised by all this were discussed. authors for their corrections and amendments. the final document has been reviewed by all the authors. we will now review the questions posed, the arguments made and the conclusion reached for each one. what do we mean when we talk about the elderly? how many are there in spain? how many will there be in the near future? presentation: the who publishes reports on ageing and health, or old age and its consequences, on a regular basis, at least since the 's. cited here are a few more. we reproduce a paragraph in full [ , ] "today, for the first time in history, most people can aspire to live beyond the age of . in low and middle-income countries, this is largely due to the significant reduction in mortality in the early stages of life, especially during childbirth and infancy, and in mortality from infectious diseases. in high-income countries, the sustained increase in life expectancy today is mainly due to the decline in mortality among older people". the report focuses on a redefinition of healthy ageing based on the notion of functional capacity: the combination of the individual's intrinsic capacity, relevant environmental characteristics and the interactions between the individual and these characteristics. in spain, according to data from the national institute of statistics [ ] , . % of the population is currently over . that's about . million people. if we focus on those over , they currently account for % of the total population (about . million). forecasts for put the number of people over years old at million ( . % of the population) and those over at . million ( . % of the population). thus, between and , the number of people over will have increased by a factor of (from . to million), and the percentage will have increased by a factor of (from . to . %), while the number of people over will have increased by a factor of (from , to . million) and the percentage will have increased by a factor of (from . to . per %). once the figures have been established, it is necessary to clarify that, according to the dictionary of the royal spanish academy of language (drael), "old" is "that person of age, commonly one who has turned ". however, age is a purely theoretical value to distinguish a person as "old" or "elderly". taking the age of as the threshold for the onset of old age dates back to the late th century, when less than % of those born reached that age. today, more than % of people reach the age of , so this age limit is shifting towards older ages. nowadays the concept of "old" is more related to "function" than to age. thus, the drael defines health as "that state in which the organic being normally exercises all its functions". therefore, one of the most relevant aspects in considering a person "old" is that they need help to carry out the activities of daily life (bathing, dressing, feeding, moving, etc.). we can find totally independent people in their 's and others with a high degree of dependency in their 's. formato es el de la discusión de una serie de preguntas preformuladas que fueron discutidas entre todos los presentes. empezamos discutiendo el concepto de "anciano", las razones de la predisposición a la infección, las infecciones más frecuentes y sus causas, y la carga laboral y económica que suponen para la sociedad. también preguntamos si teníamos datos para estimar la proporción de estas infecciones que podrían ser reducidas por programas específicos, incluyendo programas de vacunación. en este contexto, se discutió la baja presencia de este problema en los medios de comunicación, la posición de las asociaciones científicas y de pacientes sobre el problema y los aspectos éticos que todo esto plantea. the ageing of the population in more developed societies is an incontrovertible fact. in the face of the indisputable success in achieving a longer life for a large proportion of the population, questions arise as to the viability of social protection systems. by , over % of the population will be classed as elderly and their quality of life will depend, to a large extent, on avoiding preventable diseases such as infectious diseases. it is a well-known fact that the elderly constitutes a risk group for distinct types of infectious diseases, whose diagnosis and treatment are hindered by several factors. around this fundamental fact, however, we find a lack of answers to simple questions about the size of the problem, its epidemiology, the capacity of the social response to it and the need to plan useful preventive measures to minimise risk and reduce costs. for this reason, the health sciences foundation, which has prevention as one of its main objectives, has organised a discussion and opinion meeting on the infectious diseases situation in the elderly in spain, aiming to answer a series of questions accepted by all the participants. greater difficulty in eliminating secretions. in the digestive tract it is common to find diverticuli in the mucosa that act as microorganism reservoirs. also, losses in secretory function with a tendency to gastric achlorhydria, but, above all, motor function which at oesophageal level, can favour aspiration phenomena. in the urogenital system there are usually alterations arising from pregnancy, childbirth, previous surgeries and local manipulations that make the free flow of urine difficult. in this vein, it is worth adding the frequency of subjecting the elderly to diagnostic or therapeutic examinations that may favour infections. in addition to the deterioration of mechanical barriers, there are losses in non-specific defence mechanisms. these include limitation to increase blood flow and vascular permeability at the infection entry points. the ability to mobilise polymorphonuclear leukocytes rapidly and the agility of phagocyte function is also impaired. chemotactic capacity decreases from the age of , as does the capacity for the intracellular destruction of microorganisms. ageing is associated with a chronic, progressive, nonspecific, low-level pro-inflammatory state, for which the english literature has coined the term "inflammageing", which favours an environment conducive to infection and further limits the possibilities of an effective response to it. the deterioration of adaptive immunity ("immunosenescence") associated with the ageing process has been known for years and affects both innate and acquired immunity [ ] [ ] [ ] . immunosenescence includes qualitative losses in t-lymphocyte subpopulations with decreased activity of cd- helpers, cytotoxic cd- s and a limitation in generating t-cell growth factor. ageing determines a tendency to invert the cd /cd t-cell ratio. the number of dendritic cells decreases with age and the response of nk cells to stimulating cytokines is limited. it also increases the activity of cd- suppressors. b-lymphocytes are limited in their ability to produce antibodies and to respond to external antigens. furthermore, there is an increase in the production of autoantibodies and circulating immune complexes. a third group of factors that add to the microorganisms and the individual are environmental and social factors, such as hygiene neglect, poverty, isolation and a sedentary lifestyle. the fact of living in nursing homes and the increase in hospitalisations favours an insufficiently quantified environmental exposure [ ] . there are multiple factors that explain the higher incidence of infections in the elderly. the clearest are those that have to do with alterations of the defensive barrier mechanisms. immunosenescence is a complex concept involving various alterations in the immunity of the elderly. what are the main clinical syndromes of infection in the elderly? the frequency and even the aetiology of infections af-therefore, the "elderly" is an enormously heterogeneous group in aspects such as the prevalence of chronic diseases (ischaemic heart disease, hypertension, diabetes, copd, etc), the need for consumption of drugs and the existence or nonexistence of physical, mental (dementia, depression) and social (loneliness, isolation, poverty) problems. conclusion: -the definition of elderly is artificial and refers to any person over a certain age (which can be set at , or older) who has serious limitations in the exercise of their physical, mental or social functions. -in our society, currently, almost % of the population would meet a definition of elderly based exclusively on the criterion of age, but it is estimated that, with this criterion, the percentage in spain will be greater than % by the year . the changes that take place throughout the ageing process favour the existence of infections. the simplest explanation is that with age the numerator of the aggression/defence equation increases (greater arrival of microorganisms that are also more virulent) and the denominator decreases (less defence capacity on the part of the organism). we can therefore divide the causes of the elderly person's predisposition to infection into those that depend on the microorganisms and those that depend on the host's defence mechanisms. there is no evidence that the microbiota of the elderly is quantitatively different from that of younger populations, nor necessarily more aggressive. however, it is an incontestable fact that previous infections, antimicrobial treatments, the greater ease of microorganism acquisition and living in proximity to other elderly people, can predispose the elderly to colonization and subsequent infection by multi-resistant microorganisms, with the presence of "superinfections", with a worse response to antimicrobials and increased resistance to them. in terms of host defence mechanisms, there are many factors that make the elderly more labile. mechanical barriers, for example, are the first element of defence, but they deteriorate progressively throughout the ageing process, facilitating the entry of microorganisms. the skin and mucous membranes experience physiological losses and often also those resulting from local or systemic diseases. the most important changes are: thinning, with loss of epithelial and mucosal cells, worse hydration and vascularization, loss of elasticity, decrease in mucous gland secretions of antimicrobial peptides, worse healing, loss of cellular macrophages in the skin (langerhans cells) and immobility with increased local pressure in certain areas. in the respiratory system, there is a decrease in the number of cilia and a slowing down of their activity, a reduction of alveolar macrophages, a decrease of the cough reflex and pend on their situation. in independent elderly people, the most common infections are respiratory conditions caused by viruses or bacteria prevalent in the community, urinary tract infections and intra-abdominal infections. in contrast, in institutionalised elderly people, bladder catheter-related utis, aspiration pneumonias, skin and soft tissue infections, and infections of the gastrointestinal tract predominate. which microorganisms are most common? how does the problem of multi-resistance impact on the elderly? presentation: it is important to remember that infections in the elderly may be caused by a greater variety of microorganisms than in the younger population, so it is essential to obtain samples for culture before administering empirical antimicrobial treatment [ ] . thus, for example, while the vast majority of utis in young patients are caused by e. coli, in the elderly their relative importance is less. in the case of pneumonia, there is a higher incidence of gram-negative bacilli (gnb) and as far as meningitis is concerned, they are rarely of viral aetiology, while we must consider gnb and listeria monocytogenes. in a spanish study, including elderly patients (mean age . years), with utis, the most frequently isolated microorganisms were e. coli, ( %), enterococcus faecalis ( %), klebsiella pneumoniae ( %) and pseudomonas aeruginosa ( %). in up to % of cases, more than one microorganism was isolated in the urine. the frequency of bacteraemia was higher with e. coli and lower with e. faecalis and p. aeruginosa and bacteraemia was not associated with a worse prognosis [ ] . the frequency of multi-resistance increases with age and comorbidity. in this spanish study, the proportion of extended-spectrum beta-lactamase (esbl) producing e. coli and k. pneumoniae isolates was . % and . %, respectively. in the previously mentioned study of patients attending the emergency department, the elderly accumulated more risk factors for multi-resistance (p < . ) and suffered from septic syndrome more frequently (p < . ) [ ] . there are few studies that analyse the overall aetiology of respiratory infections in older patients, and most work focuses on describing specific populations or groups of pathogens. the aetiological affiliation rate of respiratory infections in the elderly is very low (< %), and this is due, among other things, to the difficulty many patients have in producing sputum and to the high frequency of empirical treatment [ ] . if we analyse the aetiology of cap, the most frequent pathogen is s. pneumoniae ( - %), followed by h. influenzae ( - %), respiratory viruses ( - %), legionella spp.( - %) and gnb ( - %) . it is also necessary to remember the importance of viral pathogens in this population, since the prescription rate of unnecessary antimicrobials is very high in them ( % of the elderly with viral symptoms) [ ] . in a study conducted in china, in sentinel hospitals, it was observed that . % of elderly patients with respiratory infection had a viral aetiology ( . % among extra-hospital infections and . % among fecting the elderly vary depending on the clinical environment (home, nursing home, hospital) and the functional status of the patient. in older, independent and healthy people, respiratory conditions caused by viruses or bacteria prevalent in the community, urinary tract infections (utis), whether catheter-related or not, and intra-abdominal infections (cholecystitis, diverticulitis) are common. in contrast, in institutionalised elderly people, utis related to the bladder catheter, aspiration pneumonia, skin and soft tissue infections and those of the gastro-intestinal tract (git) predominate. in hospitalised elderly people we have to consider nosocomial pneumonia, intravascular catheter associated infections and c. difficile infections as the most prevalent [ ] [ ] [ ] [ ] [ ] [ ] [ ] . there is limited data analysing the comparative overall frequency of the different syndromes. in elderly people living in nursing homes, utis (at least - % of healthcare-associated infections), respiratory infections, skin and soft tissue infections and those of the git predominate [ ] . in a recent spanish multicentre descriptive study, conducted in emergency departments, , patients were included, of whom , ( . %) were at least years old. compared to younger adults, older patients (mean . years) had respiratory, urinary and intra-abdominal infections more often, while there was no difference in the frequency of other syndromes [ ] . these data are confirmed in chinese studies that analyse elderly patients attending emergency departments and also show a significantly higher incidence of respiratory and urinary infections [ , ] . in the case of utis, the relative prevalence is influenced by the gender of the patient. thus, for long-term care facility (ltcf) residents and in hospitalised elderly people, uti is the number one cause of infection and is the second most common in older women living in the community [ ] . the incidence in men ranges from . /person year ( / ) in men aged - and reaches . ( / ) in men over . in women, the incidence of uti increases with menopause ( . per person/ year: / ), increasing to . per person-year ( / . ) after age [ ] . in indwelling catheter-wearing patients, the incidence of utis is . cases per , catheter days, compared to only . per , days for all residents (x ). urinary tract bacteraemia was - times more common in patients with permanent urinary catheterization [ ] and uti is also the most frequent cause of community-acquired bacteraemia in the elderly ( - %). with respect to respiratory infections, the annual incidence of community acquired pneumonia (cap) ranges from - . episodes per , people over years of age and represents - % of hospitalisations in this age group [ ] . in japan, % of deaths from pneumonia occur in patients over years of age. the risk of cap is times higher in those over compared to those under and . times higher in those over compared to adults aged - . viral infections are also common in this age range, as we will see later. the most prevalent infections in the elderly de-is estimated at between and episodes per , days of stay in the residence [ , ] . the figures rise to for those with some kind of prosthetic material [ ] . we have several european halt studies (healthcare-associated infections and antimicrobial use in long term care facilities), with participation from countries, including spain, with a prevalence of infection of . % and % at two different times [ ] [ ] [ ] . a french multi-centre study, conducted in nursing homes with , beds, shows an infection prevalence of . % [ ] . the first data on infection in nursing homes in spain come from the epinger study, conducted in community health centres in catalonia, which reported a prevalence of . %, although it should be pointed out that in catalonia the concept of the community health centre would include medium-long term patients, while in the rest of the spanish autonomous communities this concept would be limited to nursing homes [ ] . in another study, conducted by san sebastian's fundación matía, an infection prevalence between . % and . % was reported [ ] . data derived from the vincat study in catalonia show a prevalence of healthcare-associated infection in long-term care centres of . %, with a great diversity, depending on the type of care unit (subacute . %, palliative . %, convalescent . %, long stay . %) [ ] . home is the most recommendable place for the healthy elderly to live, and even for the elderly patient, with healthcare falling to primary care professionals, although sometimes with the collaboration of some hospital resources. the ministry of health, social services and equality has for the first time published the results of the primary care clinical database (bdcap), a tool that allows for a more precise and systematized knowledge of the main health problems in spain dealt with by the doctors on the healthcare frontline. thanks to this register, a detailed picture of the health problems of the spanish population is available from primary care [ ] . in this database, infections appear among those over years old with an elevated frequency of . cases a year per , people ( . ‰ men and . ‰ women). the most frequent correspond to the respiratory system ( cases/ persons/year), followed by urinary tract infections with ( . cases/ persons/year) and clear female predominance. finally, nosocomial infections are those that occur in hospitalized patients and are present more than hours after admission. they are acquired by transmission from the environment, from other patients or from healthcare personnel. they are considered to be the most preventable cause of serious adverse events in hospitalised patients [ ] . in general, these infections are related to invasive diagnostic or therapeutic procedures (urethral catheterization, surgical procedure, vascular catheter, invasive mechanical ventilation), all of which have in common the disruption of the host's own defences by a device or an incision, allowing the invasion of nosocomial infections) [ ] . the most common cause was influenza ( % of all patients studied). rsv is also a significant pathogen in this population [ , ] . the most important cause of git infection in the elderly is clostridioides difficile. c. difficile (c-diff) infection is currently the most prevalent nosocomial infection, affecting in more than % of the episodes patients over years of age [ ] . moreover, it is in this population that c-diff causes the highest morbidity and mortality, with an increase in c-diff-related mortality from . to . deaths per million population per year from to [ ] in patients with an average age of years having been described in the usa. it is interesting to note the safety of using the same therapeutic options in elderly patients, including faecal microbiota transplantation [ , ] . the microorganisms causing infection in the elderly are qualitatively the same as in the population of other age groups, although there are quantitative variations. where do they get these infections? what proportion are acquired in nursing homes? at home? in hospital? - in addition to the hospital and home environment, the elderly can acquire infections elsewhere, and in particular in other care units. this is the reason why, almost years ago ( ), the term "health care-associated infection" began to be used, which is not only limited to hospitalized patients, but also extends the concept to patients in contact with the health system (home care of patients with high comorbidity and complexity; day care centres; major outpatient surgery units; outpatient dialysis centres; community health centres for chronic or convalescent patients). to a great extent, it is in nursing homes where patients with more comorbidities, polypharmacy consumption, a high degree of dependency and a high prevalence of invasive devices (bladder catheter, nasogastric tube, percutaneous gastrostomy) will be treated. in addition, the environment can facilitate the transmission of microorganisms between residents and healthcare personnel, as well as between residents. for all these reasons and the excessive or inappropriate use of broad-spectrum antibiotics, either empirically or prophylactically, multi-drug-resistant (mdr) infections can be generated. implementation of effective preventive measures in this population is very difficult to organise. in the united states of america, it is estimated that approximately . million people live in nursing homes and suffer between . and million episodes of infection annually [ ] . the prevalence of infections in these residences is estimated at % of the residents [ ] and the incidence of new infections infectious diseases are the second cause of such admissions ( . %), only surpassed by cardiovascular diseases ( . %). pneumonia and sepsis are the most common infections causing admission in this population [ ] . the elderly population also has longer hospital stays ( . days for those over ≥ ) than those between and ( . days) and those between and ( . days) [ ] . the elderly are treated by virtually every unit in a hospital but it is worth mentioning that those over years of age represent % of those admitted to intensive care units [ ] . the other group of interest is that of specialised geriatric units, not available in all hospitals, which have been shown to improve the functional status of patients and reduce the number of discharges to long-term care homes [ ] . in a study by saliba et al., conducted in israel [ ] , out of a total of , hospital admissions in the elderly between and , the proportion of admissions due to infectious diseases rose from . % in to . % in . globally, the most frequent infections causing admission were: those of the lower respiratory tract (lrt) ( . %), followed by the utis ( . %), upper respiratory tract ( . %) and hepatobiliary ( . %). in spain we do not have precise answers to the questions asked. the proportion of serious infections in the elderly requiring hospitalisation depends on several factors: type of infection, severity of infection and other factors such as the degree of frailty of the elderly, their place of residence and their ability to receive care at home. the environment and the resources available also influence the hospitalisation decision. however, in our environment, most serious infections in the elderly will require hospitalisation for at least a few hours. in spain, serious infections in the elderly can be treated by different professionals depending on the type and severity of the infection, and the environment in which it occurs. a high percentage are treated by "generalists" hospital specialists, or geriatricians. where infectious disease specialists are available they are of course involved in their management, either in beds in their own departments or as consultants. they can also be treated by specialists of the affected organ such as orthopaedic surgeons in the case of infections of prosthetic material, or vascular surgeons in the case of infections of vascular ulcers. and if, in the end, hospital admission is not decided, the patient is cared for by the primary care team. as an example, we have collated the urinary tract infections treated at the hospital general universitario gregorio marañón between and . when uti is the main diagnosis that motivates admission (about cases a year) about % of cases are cared in the medical departments. when it comes to secondary diagnosis (about , cases per year), the internal medicine and geriatrics departments take care of about % of the cases. preventive programmes, such as flu vaccination programmes, reduce the need for hospitalisation for respiratory infections by nearly %, both inside and outside spain [ ] [ ] [ ] . microorganisms that are part of the patient's usual microbiota (endogenous microbiota), or selected by the selective antibiotic pressure (secondary endogenous microbiota), or by one found in the hospital environment (exogenous microbiota). to understand the main epidemiological data on hospital infections, the epine study (estudio de prevalencia de las infecciones nosocomiales en españa (study on the prevalence of nosocomial infections in spain)) was developed. this is a multi-centre system for monitoring nosocomial infections, based on the production of an annual prevalence study, which has been conducted since in a large group of hospitals in spain and was promoted by the spanish society of preventive medicine, public health and hygiene. its methodology guarantees a homogeneous and systematic collection of information, which allows us to understand the prevalence of healthcare-associated infections (hais) at a national level, by autonomous regions and hospitals. since , every years the epine study has been produced jointly with the european study (in and ) under the coordination of the ecdc [ ] . based on the latest data published, in november ( hospitals and , patients), a prevalence of nosocomial infection in patients over years of age of . % (infections acquired during the current admission), . % (infection acquired during the current or previous admission) and . % (the total, including the centre's own or imported) has been reported. it should also be noted that this register shows that in % of patients over years of age admitted for an infection, the infection had been acquired in the community (patient's home). the home, nursing homes and community health centres, healthcare centres other than hospitals and the hospital itself are often the places where the elderly acquire infections. the studies reviewed allow us to estimate a prevalence of infection of between and % in nursing homes in spain, depending on their complexity, and between and % in hospitalised elderly people. in primary care and in the residential environment, there is no homogeneous epidemiological record of this problem. what proportion of severe infections in the elderly require hospitalisation? by whom are they treated? in the united states of america, patients over years of age account for almost % of total adult admissions and the cost of these hospitalisations represents nearly % of the total cost for hospitalisation, although those over years of age account for less than % of the total adult population [ , ] . those over years of age are admitted to hospital three times more often than those between and years of age, and those aged or over account for . % of all hospital discharges, although they represent only . % of the population as a whole. moreover, in our opinion, in these departments, emergency assessment should not be focused only on the isolated episode for which the patient consults, but the particulars of the elderly person, their functional, mental and social situation should be taken into account. this is a huge workload for the ed. finally, we should bear in mind that the training of ed physicians on these issues is limited [ ] as a direct consequence of the self-training of current professionals, which is not always complete, and the lack of a regulated medical specialty in the ed. in spain, between and % of emergency department visits occur in the elderly. elderly people come in . % of the time for infections and one third of the infections seen in the emergency departments occur in the elderly. the population over years of age who attend the emergency department often have multiple pathologies and clinical manifestations of infection that may be atypical. in the spanish national health service, emergency activity accounts for a total of . million consultations per year, of which . million are attended to in primary care (pc) (outpatient or home), with an average attendance of . people/ year [ ] one-third of emergency consultations in pc are related to infections [ ] . in the older patient, infections are more frequent and serious, associated with greater morbidity and mortality [ ] [ ] [ ] . among the elderly, the rate of infection reaches . cases per thousand people per year. the most frequent correspond to the respiratory system ( cases per thousand), particularly those of the upper respiratory tract, followed by acute bronchitis and bronchiolitis and pneumonia [ , [ ] [ ] [ ] . in second place are utis, mainly affecting women ( . cases per thousand compared to . per thousand for men) [ ]. these are followed by skin and soft tissue infections [ ] . most of these cases are dealt with in primary care and only those more serious situations and of uncertain diagnosis are referred. in %- % of cases, cap is diagnosed in pc [ , ] and streptococcus pneumoniae is the cause of two-thirds of these cases. invasive forms of pneumococcal disease (ipd) are less common, occur in patients with certain risk factors and have high mortality rates [ ] . the vast majority of vaccination programmes in spain are carried out in primary care, but the vaccination schedule for older people is neither complete nor promoted as it should be. what is the workload represented by elderly patients in hospital emergency departments? the number of visits to hospital emergency departments (ed) has been increasing progressively for decades. this increase is greater in the elderly, whose population accounts for - % of all visits to the hospital [ ] . the incidence and impact of infection in the ed is estimated quite reliably. in spain it is . %, % in the usa and around - % in countries such as nicaragua and mexico [ ] . the elderly are characterised by a higher probability of atypical presentation of diseases, of suffering from multiple diseases and of consuming many drugs. with regard to emergency care, this implies a more complex clinical evaluation, which translates into a greater request for additional tests and consultations with other specialists, longer stays in the ed (extended periods under observation and in ssus), as well as a greater probability of admission, discharge with undetected or untreated problems and return visits to the ed [ ] . all this entails a high risk of adverse episodes [ ] and a significant impact on healthcare pressure, resulting in a negative effect on ed saturation [ , ] . likewise, the prevalence of the frail elderly in the community varies according to the diagnostic criteria. in a study conducted on elderly people admitted to the observation room of an ed in a spanish tertiary hospital, it was verified that only one of them did not have any fragility criteria and on admission almost half of them suffered significant dependence [ ] . the detection of the high-risk or fragile patient is fundamental for these departments, for decision-making and in particular for discharge directly from the emergency department. we could highlight that in the recent work of the in-fur-semes group, in a study conducted in spanish eds, . % of infections occurred in patients over years old. of these, % were urinary and . % were lower respiratory. in conclusion, when compared with a similar study, conducted twelve years earlier, an increase in the prevalence of infections is observed, with an older patient profile, comorbidity, risk factors for mdr microorganisms and septic syndrome [ ] . the latter almost always presents itself as an acute confusional syndrome, which implies a complex differential diagnosis. to what extent do you think that infection in the elderly is preventable? what proportion could be avoided with proper vaccination? in an article published by umscheid et al. [ ] , not specifically addressing to the elderly field, it is estimated that %- % of cases of catheter-related bacteraemia or catheter-associated urinary tract infection and % of pneumonias from mechanical ventilation or skin and soft tissue infections could be prevented in the hospital environment using the methodology currently available. an infection control programme for older patients includes methods for surveillance and recording of infections, recording and management of multi-resistant microorganisms, outbreak contingency plans, isolation policy and standard precautions, hand hygiene programmes, ongoing education of employees, resident health plans, audits and plans for reporting incidents to health authorities [ ] . this set of resources is not available to most of the world's elderly. a group of experts, gathered in a delphi study on infection prevention measures in patients admitted to institutions for the elderly, agreed on recommendations [ ] but unfortunately the level of evidence on the effectiveness of each of them is very limited. data on the reduction of different infections by different measures are extremely scattered and limited. some examples are the reduction by % of periprosthetic infections with antibiotic prophylaxis [ ] , a % reduction in episodes of influenza with the physical separation of the young and the elderly, [ ] or a % reduction in episodes of pneumococcal pneumonia with the -valent vaccine [ ] . makris et al. [ ] conducted a study to test the effect of an infection control programme in institutions for the elderly in the united states of america. they divided the centres into test centres ( ) and control centres ( ) and studied the incidence of infections in both groups before and after the programme was introduced. in the year prior to the intervention, test sites experienced infections (incidence density rate, . ) and control sites infections (incidence density rate, . ). in the intervention year, the test centres reported infections, a decrease of infections (incidence density rate, . ), while in the control centres, the number of infections increased slightly to (incidence density rate, . ). the greatest reduction in infections at the testing centres was in upper respiratory tract infections (p = . ). the intervention programme consisted mainly of implementing environmental cleanliness, hand washing programmes and educational talks. therefore, and speculatively, we dare to estimate that a the infection rate in the elderly exceeds episodes per , sick people per year. primary care handles the vast majority of these episodes and refers only the most serious cases. primary care is responsible for the vaccination programme for elderly people who attend to request it. the vaccination schedule for older people is neither comprehensive nor proactively promoted. what does infection in the elderly entail in terms of days of hospitalisation, financial expenditure and death? to approximate data/figures for variables such as "days of hospitalisation, economic expenditure and death" in a field as broad as "infection in the elderly" is enormously complicated. it must be taken into account that the infectious pathology is very varied and that it can affect people with different locations (community, community health centre or the hospital itself) and conditions. for example, with reference to nursing homes, lim et al. estimate episodes of infection for every , cumulative days spent in the home in a small group in australia [ ] , while much more extensive north american data report % of nursing home residents having an infection at the time of the study [ ] . this leads to estimates of between . and . million episodes of infection per year [ ] with annual costs of no less than us$ billion, prior to . in a study conducted in brazil, the cost of an infection in the elderly requiring admission is estimated at , brazilian reals (€ , ). patients are admitted for a median of days compared to a median of days for elderly people admitted for non-infectious causes [ ] . of that cost, only % is attributable to the purchase of antibiotics. there is a greater volume of data for community-acquired pneumonia (cap) [ ] [ ] [ ] [ ] . the cost of cap varies greatly depending on where the treatment takes place. a spanish study [ ] found a cost of only € in the case of an outpatient, compared to € , for pneumonia requiring hospitalisation. the costs were higher for subjects ≥ years. mortality increases significantly in the older patient ( %) with respect to the general population ( %). it is worth noting a publication in spain with a sample of , subjects, where mortality due to pneumonia is more clearly related to the age group than to the aetiological agent [ ] . we have not found precise data calculating overall clearly no one disputes the usefulness of ongoing education in many aspects of life and particularly in the reduction of nosocomial infections. that said, the literature review on the impact of educational programmes on nosocomial infection is irregular, fragmented and often difficult to assess. published studies generally include education as part of intervention programmes in which other measures are included, making it difficult to assess the role of education in isolation. it is also common to talk about the success or failure of an educational programme without detailing what the programme is, what content it has, how it has been implemented and how many people have accessed it. to complicate matters, in the case of the elderly, we have at least three different areas: home, nursing homes and institutions for the elderly and hospitals. in the first, the educational scope is very general and imprecise and is based on the public health and vaccination campaigns that are usually received not only by the elderly population but by the population in general. in the hospital field, we must assume that the literature produced on the impact of educational measures in the different syndromic entities generally includes the elderly population, but does not specifically differentiate it. most of the limited existing information, which we can consider specific to older people, is that generated in nursing homes and institutions that implement these programmes. a study conducted in the usa on , randomly selected nursing homes [ ] asked the homes for information on points related to infection control programmes. most of those responsible for control programmes, when they responded, claimed to have not only that responsibility but others as well ( %) and also to have no specific training in infection prevention ( %). there was great variability in practices carried out in each residence and % acknowledged having received an official citation for deficiencies in such control. those residences cited for deficiencies had a statistically lower proportion of staff trained in infection control. this is therefore an area with clear opportunities for improvement. in a systematic review on non-pharmacological infection prevention in long-term care facilities, only papers were selected, the majority of which were randomised studies ( %) and the most common reason was prevention of pneumonia ( %). % showed favourable results for the interventions, but the studies had many potential biases [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . from these studies the main quality markers in infection control in a nursing home were deduced, namely: percentage of long-term patients with pressure ulcers, urinary tract infection, bladder catheter, and vaccinated against influenza and pneumococcal infection. high quality infection control programme in nursing homes could reduce infection rates by up to %. but even if we estimate much lower figures, the impact on morbidity, mortality and the economy of such programmes would be enormous and would certainly outweigh their implementation costs. with reference to the second part of the question, the possibility of reducing the problem with vaccines, the data are again scattered and studied for different vaccines individually. in addition, information on the elderly must often be inferred from data on the general population. we refer readers to a recent review on the subject [ ] . below is some data on the impact of vaccines of particular interest to the older population. gross et al. [ ] in a meta-analysis of cohort studies estimate the effectiveness of influenza vaccination at % in preventing respiratory infections, % in preventing pneumonia, % in preventing hospitalisations and % in preventing deaths. in the case of zoster, the vaccine's efficacy is estimated at more than % with minimal adverse effects [ ] different pneumococcal vaccines have different impacts on the incidence of invasive pneumococcal disease (ipd) infection. a systematic review shows reductions in ipd incidence ranging from % as a combined effect of the use of pcv , pcv and pcv in those over in canada [ ] to a % reduction as an effect of the use of pcv and pcv in israel [ ] . with these data it is possible to imagine the added protection that adequate vaccine coverage would provide. an estimated , americans die each year from vaccine-preventable diseases, and % of those who die are adults [ ] . increased provision of medical care in large care homes (e.g. those with more than - beds) could reduce the referral of many elderly residents to hospital emergency services. this provision of medical care would not necessarily be very complex and would cover both simple diagnostic material and the possibility of establishing and carrying out pharmacological therapeutic courses at the centre itself, the prescription of which in most cases still requires medical staff from outside the centre. it would be a way to reduce costs, lessen the burden on the elderly and reduce the overload on hospital emergency departments. it is impossible to give a precise answer to the questions asked, but it seems reasonable to assume that with appropriate prevention programmes, acquired infections in institutionalised elderly people could be reduced by up to %. strict adherence to a vaccination programme for the elderly would have an enormous impact on reducing suffering, death and economic waste. what data exist on the effectiveness of educational measures on the incidence of infection in the elderly? ties specifically dedicated to infection. by way of an example, in spain, this occurs among specialists in microbiology and infectious diseases and intensive care specialists. .-specifically promote research aimed at preventing infection in elderly patients. .-introduce much more active involvement of patient associations in their management structures. what we say about societies primarily dedicated to the elderly, can be similarly assumed and applied to societies primarily dedicated to infectious diseases and microbiology. the role of the scientific societies dedicated to geriatrics and infectious diseases is to promote alliances in the common field of infection, in aspects of care, teaching and research. they need to look less to the interests of their members and be more proactive in promoting the interests of the patients they serve and incorporate patient associations more into their structures. capacity, understood as the possibility or potential for influence, is qualified by two variables. firstly, for offering free and truthful scientific information at the service of the community. and secondly, for facilitating the adoption of the best possible political decisions with consistency and realism. the rapprochement between professionals in the scientific and political fields must be adjusted to the interest of citizens, who can act as the third pillar in a transparent relationship model and as guarantor of equity befitting a democratic system of government [ ] . while scientific experts advise and inform, it is the responsibility of politicians to make decisions and promote efficient measures to the benefit of the population. a complementary characteristic inherent to the scientific task is to exercise a dissemination action of the activity itself, in understandable terms and through accessible and reliable systems [ ] . the configuration of platforms within scientific societies and the growing number of independent agencies advising political power represent a reality that aims to bring the contributions of science closer to the systems of governance [ ] . in our country, the main function of the congress of deputies is legislative, which entails the approval of laws. the constitution recognises the legislative initiative of the government, the congress of deputies, the senate, the assemblies of the autonomous communities and the people's legislative initiative on the proposal of no less than , citizens, subject to the provisions of an organic law. these bills are known in spain as law projects when presented by the government and propositions in other cases. they are always submitted to the congress of deputies, except for the propositions of the senate which have to be considered scientific societies are professional associations that bring together generally specific groups (doctors, nurses, technicians, etc.) that essentially seek to defend the professional interests of their members. until now, it has not been common for groups of patients affected by different diseases under the thematic umbrella of each society to participate in them. in spain their impact and political credit is variable. among the most important objectives of most of these societies are such issues as training programmes for professionals, aspects related to the health education of the population in their particular field of competence, research grants, the preparation -sometimes in collaboration with societies of another related specialty -of specific diagnostic and therapeutic protocols, publications and congresses focussed on these topics, and a wide range of other activities, including health policy recommendations to the corresponding administrations that have a direct bearing on the issues discussed here. membership of societies is also not uniform, and often it is the more "senior" components of the profession that are most highly represented in them. their role, in our opinion, is to continue to improve the teaching, care and research produced in the societies' chosen fields in favour of patients, exercising ever greater mediation between the demands of patients and healthcare administration [ ] . all societies must go far beyond issuing guidelines and therapeutic recommendations [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . in our view, scientific societies dealing with diseases of the elderly should promote, in the field of infectious diseases, among others, the following topics: .-encourage a proportionate share of its members to subspecialise in infectious diseases. .-coordinate and direct multidisciplinary teams specifically dedicated to the infection in the elderly and its prevention. .-participate more actively in specific programmes to reduce infections in the elderly, both at the nursing home level and at home and in hospital. .-implement vaccination campaigns in the elderly, taking particular advantage of admission to long-stay centres or hospital as opportunities to vaccinate. .-to design and disseminate educational projects on infection prevention practices for the elderly in their different environments. .-put pressure on health authorities to carry out a large national programme to reduce infection in older people. .-to include in the training programme of residents in geriatrics, a rotation in infectious diseases and microbiology as an essential part of the curriculum. .-create scientific and professional alliances with socie-to offer a unique system to access scientific information allowing the recovery of different types of documents such as: journals, books, images, theses, and conference proceedings. revista española de geriatría y gerontología (the spanish journal of geriatrics and gerontology) is the publication channel of the society of the same name, a publication founded in and the doyenne of the specialty in the spanish language [ ] . medes is an initiative of the fundación lilly and its database, open and free, contains bibliographical references published since in a selection of spanish journals covering subjects in medicine, pharmacy and nursing, published in spanish, with , articles [ ] . finally, pubmed is the widely implemented search engine, with free access to the medline database of citations and abstracts of biomedical research articles, offered by the united states national library of medicine and integrating , worldwide journals since [ ] . the search was conducted with a double strategy: free text and controlled text using "mesh". in the first strategy, a free text search was conducted in the "science direct" and "clinical key" databases with the term 'infection in geriatrics' resulting in and , findings respectively. the primo search engine (castilla y león online library) returned a total of results for the same term. secondly, and also in free text, with the term 'infection in the elderly', we proceeded to consult revista española de geriatría (the spanish journal of geriatrics), which generated results and medes (medicine in spanish) with results. the second strategy of controlled text was conducted in the pubmed database, returning the following findings: <infection and geriatrics>: results; <infection and aged> (people from to years old): . results and <infection and aged or aged, and over>: . results (identical to the previous one). its development over the last decade has been progressive (from figures close to , in the - biennium, to over , from to ), excluding the year from the assessment. we have adopted their classification into thematic areas [ ] and the twelve in which % of the results were concentrated are: sepsis and bacteraemia, pneumonia, urinary tract infections, central nervous system infections, endocarditis, prosthetic infections, skin infections, gastrointestinal infection, hiv infection, fever of unknown origin, multi-resistance and vaccinations. the scientific output on infections in the elderly, calculated by different databases, has been increasing in the last decade. how do the problems of the elderly impact on the mainstream media? how should the media contribute to the reduction of infection in the elderly? the impact of the problems of the elderly in the media is in the senate, which will later submit them to congress [ ] . non-legislative bills, motions and proposals for resolutions are acts of a similar nature that seek the adoption of a non-legislative resolution by congress, by which congress expresses its position on a given subject or issue, or addresses the government urging it to act in a particular direction. the health and social services commission of the congress in the xii legislature offers access on its website to the initiatives processed since its constitution in september until its dissolution in march , representing an average of per year [ ] . of these, those referring to the field of infectious pathology as a whole do not exceed %. of particular relevance in the field of infectious pathology have been those relating to the national plan for the elimination of hepatitis c and antibiotic resistance. governance designates the effectiveness, quality and good orientation of state intervention, which provides the state with a good part of its legitimacy in what is sometimes defined as a "new way of governing". above all, it is used in economic, social and institutional operational terms [ ] . an inherent aspect of the exercise of policy is the performance of "authority", which is equally composed of legitimacy (right to exercise), personal prestige (moral strength, leadership, honesty, knowledge, efficiency) and power (ability to administer and lead). it is precisely in the "personal prestige" where their synergy with the scientist (also covered by knowledge, honesty and leadership) should be the lever for the improvement of the society they both serve. initiatives on proposals or projects with reference to infection issues represent less than % of the total. of particular relevance in recent years have been those relating to the national plan for the elimination of hepatitis c and antibiotic resistance. in order to respond to the scientific output on infection in geriatrics, we will proceed to describe the data sources, the search methodology and the findings, in a way deliberately guided by the recommendations of professionals in our workplace libraries. sciencedirect [ ] is a digital platform that has provided subscription access to a large research database, hosting more than million publications from , academic journals and , e-books since . clinical key [ ], owned by "elsevier clinical solutions", has an intelligent search system, establishing the connection of medical terms with related content. it accesses a collection of resources of clinical guides, algorithms and patient files from fisterra, the database of monographs of medicines marketed in spain, the treaties of the medical surgical encyclopaedia, and books and journals in spanish from the cited publisher. primo is the discovery/search tool used by the castilla y león healthcare online library [ ] as a small demonstration of this paradox -the contrast between the rising presence of the elderly in society and their lukewarm representation in the media-, we offer a chart with a comparison of publications on the websites of three generalist newspapers, "el país", "el mundo" and "abc", between the years - , with the search for "elderly" and "infection" as key words. a total of news items are recorded that mention the subject studied ( figure ). this is little news, and in most cases linked to events and to the elderly as a risk group. this sample would require further media analysis to ratify this tendency in the treatment of the problems of the elderly and the infections they suffer, but it serves as the tip of the iceberg of relegation, insensitivity and atrophy in news treatment. since the onset of the economic crisis in , the number of dedicated journalists specialising in social and health issues has been substantially reduced in order to divert manpower and resources mainly to political and economic content. if, in this situation, health, science and social issues have been scaled down and cut back in the operation of the media, the elderly, as journalistic content, have been pushed to the very margins of the newsrooms with complete normality; with no agenda, no specialists, no briefings, no planning, no contextualization; to see themselves as mere circumstantial, inconsequential, occasional content, with a light, sometimes frivolous treatment, lacking depth and sensitivity; building a narrative of topics, irrelevance and disconnection from their value and presence in society. this media portrayal of the elderly is in contrast to the ageing of the population, where reliable and accurate statistics limited, deficient, incomplete, unfocused, out of context, stereotyped and with a not particularly constructive, realistic or objective bias. the elderly are invisible in the media and when they appear, the content relating to them is characterised by simplification, victimhood, dramatization and superficiality. the image that the media convey of old age is linked to inactivity, unproductiveness, seniority, illness, dependence and deterioration. old age and its problems, circumstances, needs and contributions, as a social agent and subject, are not among the priorities and themes of general media planning. other groups, sectors, actors or social issues such as immigration, feminism, equality, children, domestic violence, ngos and their services, new technologies and their advantages, effects and risks, harassment in all its forms, health and sanitation, or scientific advances have much more visibility, relevance, monitoring, currency and presence in the media. the problems related to a stage of life that we can place at around years provoke a disinterest and sidelining in the information and journalism that only is unblocked in the face of news related to events, diseases, negative or sensationalist facts or anecdotes, offering a fixed, unmoving and old-fashioned image of a sector of the population that, nevertheless, is increasing due to the increase in life expectancy. in a world where the st century grants youth and technology all the plaudits as to what is interesting and important, whether in the press, television, radio, websites or social networks, ageing and old age, as a concept, social and population sector, and newsworthy subject, are moved to a second or third tier on the podium of current affairs and information. citations regarding "infections" in the "elderly" in major general journals of spain formation on the elderly and very elderly has been strengthened, is to promote health and healthcare information in relation to this sector of the population. in this context, the media would be in a position to treat and report, with much higher presence and representation criteria than at present, on the infections of the elderly within the framework of their health and well-being. it is very difficult to reach this third step without the two previous actions, since the handling of a health problem such as infection in the elderly by the media requires a commitment and responsibility in several phases that is part of a comprehensive strategy to provide a journalistic treatment of their problems on a par with their representation and contribution to society. it is necessary to present older people and the elderly removed from the clichés and stereotypes that link them directly and almost solely to the events, the deterioration of their health, family dependence or the hindrance or burden of their role and function in society. it is necessary to offer complete and balanced information in which tasks such as interest in culture, modernity, the future, technology or travel; their capacity to lea in civil society, family, business or education; their initiative in domestic and community tasks; their political or social contributions; or their skills in the practice of sport are inherent. in short, to show their vitality, enthusiasm, enterprise, activity, determination, solidarity or collaboration, beyond their problems or difficulties, which must also be reflected and analysed. it should not be forgotten that though the generation of elderly people now over / years old may have a more traditional, reserved and passive profile in certain cases -by no means in all-, the new generation of elderly people forecast for , where their number will rise greatly, will experience a huge change with regard to the distorted image of the elderly today. the information that the general media dedicates to the problems of the elderly is minimal, distorted and biased. it is full of clichés and stereotypes that link them directly and almost exclusively to events, the deterioration of their health, family dependency or the hindrance or burden of their role and function in society. information on infections in this population group is even more scarce. presentation: the answer is yes, without a doubt [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the reasons are detailed below: studies conducted following scientific evidence criteria in recent years show that pharmaceutical care and the intervention of the pharmacist improve the overall quality of patient care, while the who itself states that point to a doubling of the number of older people by . the data show that in in spain, there were . million children under years and . million people over years, in the number of children under had fallen to . million, and over risen to . million; by the trend becomes even more acute, with under years predicted at . million, and over , . million [ , ] . globally, in the century from to , total population will triple; the population over will grow by a factor of ; and the population over by a factor of , this last group going from million in to million in . if information concerning and affecting the elderly continues to be ignored, marginalised and simplified in the media, they will neglect and fail in their mission of gathering information, analysis, data and opinions from a sector of the population with enormous influence on the life and events of a country. without rigorous, truthful, balanced, comprehensive and complete information on the phenomenon of old age, the view and expression of reality will be distorted, fragmented and fractured. to help reduce infection in the elderly, the media must take several steps beforehand and activate new information strategies and actions [ , ] . review and reformulation of the contents for current events, relevance and interest agendas. the first step is to place general social and health issues on the same level of importance as national or international political, economic or sports information, with the consequent allocation of space, dedication and resources. enhancement of content for the elderly in social and health information. within the social and health content, the news of the old and elderly must be equated in relevance, dedication, selection, monitoring and treatment to other issues related to this journalistic field, with emphasis on the quantity and quality of the information, from the rigour, planning and contextualization to gather studies and data, human stories, opinions, difficulties and needs, social influence, contributions, and challenges in this sector of the population. the aim is to offer a complete, balanced, objective and true vision of their reality, their contributions, their heterogeneity, their variety, their complexity, their evolution and their demands and needs. the problems arising from the increase in age, health, coexistence and economic situation, as well as cultural, sociological, family and psychological aspects, must be approached with an informational style and treatment where ageing is considered from the standpoint of normality in life, with its ups and downs, and not as a hindrance, obstacle or inappropriate or unsustainable expense. the social and cultural role of the elderly, their knowledge and experience, their skills and abilities, should be valued as useful and enriching elements to society. promotion of health and sanitation information in the elderly. the next step for the media, once the general in-ed following scientific evidence criteria in recent years show that pharmaceutical care and the intervention of the pharmacist improve the overall quality of patient care, while the who itself states that pharmacists "contribute decisively to the rational use of medicines". what is the administration doing and what can it do to reduce these problems? from an educational point of view? from the legislative-regulatory point of view? in order to reduce these problems, the state administration must, among other things, launch: . prevention strategies and measures to control the transmission of the infection. .-vaccination programmes in the elderly. .-training and information programmes for health professionals, particularly in the area of rational use of antimicrobials and promotion of the use of appropriate definitions [ , ] pharmacists "contribute decisively to the rational use of medicines". the decision on how to treat a given infection correctly with the most appropriate antimicrobial requires detailed knowledge of microbiological, clinical and pharmacological issues, but the causes of an optimal result go beyond this and extend to the so-called non-pharmacological basis, among which the behaviours of doctors, patients and pharmacists, as well as the relationships between them, play a fundamental role. the pharmacist is one of the apices of the so-called "human factor triangle" (made up of doctor-patient-pharmacist), a mirror image of the famous "davis triangle" (antimicrobial-microorganism-host). currently, pharmaceutical care aims to obtain the maximum clinical benefit from medicines and to achieve the lowest possible risk in the use of those medicines, which entails the identification, resolution and prevention of medication-related problems (mrp): adverse drug reactions (adr), drug-drug interactions (ddi), deficiencies in physician prescription, errors in the use of medication by the patient and breaking the vicious circle so frequent in the use of antimicrobials formed by self-medication -noncompliance -storage. pharmaceutical care is a process, which includes different stages: active dispensation (supply, delivery, dispatch >>> assistance, help, care), educational advice (health advice in response to a consultation/problem or instruction on the acquisition of a medicine) and pharmacotherapeutic follow-up (documentation and registration of the activity). as far as the hospital pharmacist is concerned, it must be said that they not only participate actively in the rational use of antimicrobials from their role as an active member of the pharmacy commission and the antimicrobial committee, but also get involved on a daily basis in the prudent and correct application of antimicrobial therapy, in order to obtain the most beneficial result from the clinical point of view and the most efficient from the pharmaco-economic point of view. this implies that: the appropriate antimicrobial has been prescribed in accordance with a correct diagnosis and the special characteristics of the elderly patient, it is dispensed under the proper conditions, administered at the indicated doses, at the intervals and for the period intended, it is used with the lowest possible cost, in such a way as to prevent or minimise the development of bacterial resistance and it achieves the desired therapeutic objective. in short, both the community and the hospital pharmacist as first-level health agents play a central role in the field of therapeutic adherence and rational use of antimicrobials, proposing their use in terms of quality of treatment and considering antimicrobials not only by virtue of the active ingredient contained in the corresponding pharmaceutical specialty, but also in terms of useful information ("software"). furthermore, both must take into account that antibiotics and vaccines are the paradigm of societal treatment and the treatment or non-treatment of an individual can affect the community [ ] . conclusion: the answer is yes, without a doubt. studies conduct-another precaution is the sanitation of the space in which the elderly person stays so as to make it a healthy environment, including daily cleaning of surfaces, objects and utensils, ventilation, illumination preferably with natural light, and appropriate environmental temperature and humidity [ ] . the tendency to unbalanced diets, malnutrition and low fluid intake increases susceptibility to infection. it is essential to promote healthy lifestyles and to provide structured plans for eating, drinking and exercise adapted to individual needs taking preferences and health problems into account [ ] [ ] [ ] [ ] [ ] [ ] . another strategy is the vaccination of the elderly and carers, adjusted for age, particular situation and the approved schedule in each autonomous community [ ] . although infectious diseases in the elderly do not always have obvious signs and symptoms, the caregiver detects changes in their baseline situation that may lead to a suspicion of the presence of an infectious process, so education should be provided on how to proceed in the light of this suspicion and what to do when it is confirmed. finally, it is necessary to emphasise the effective management of treatment (dose, administration and side effects) and periodically monitor therapeutic adherence, avoiding self-medication, in order to achieve the optimal effects of non-pharmacological and pharmacological measures, so as to enable prevention, delay deterioration, recover or maintain health [ ] . nurses develop interventions for prevention, monitoring and therapeutic adherence control, participating in the care plan for infection in the elderly. the implementation of many of the health promotion and care plans and regulations is the direct responsibility of the nursing profession. how do senior citizens' associations deal with this problem? the issue of health is a priority for the elderly and infection in particular is one of the most frequent causes of morbidity and mortality in the elderly, as has already been mentioned. elderly associations have traditionally focused on chronic rather than acute diseases and therefore have a huge role to play in this area. it is the mission of the elderly associations to encourage and promote the residence of the elderly in a family and social environment that is agreeable to them. it is well known that an older person who lives comfortably at home with family members has less risk of acquiring infections than one who lives alone. in the case of the elderly institutionalised in residences, the elderly associations have the mission to ensure the quality tions for the prevention and control of healthcare associated infections (hais). some examples of the above are programmes such as: "antibiotics: take them seriously" ( ); the "world antibiotic awareness week" ( ); the "european antibiotic awareness day" ( ). a national plan against antimicrobial resistance (pran) run by the spanish agency of medicines and health products (aemps) is essential [ , [ ] [ ] [ ] [ ] [ ] . the administration has a constitutional mandate to promote health, which is of particular concern to groups as vulnerable as the elderly. among the measures to be implemented, those of an educational nature are especially necessary, both for patients and for their caregivers and healthcare personnel. from a legislative-regulatory point of view, we cannot forget that spain has one of the best health systems in the world. what is the role of nursing in managing and reducing infection in the elderly? how does the training of the caregiver affect this? nurses develop preventive interventions, participate in the monitoring, control, therapeutic adherence and care plan when the infection is established. these competencies are developed inside and outside of healthcare institutions. in the home setting, the focus is on education and providing support for safe practices [ ] [ ] [ ] [ ] . professionals, caregivers and elderly people have to distinguish modes of transmission, identify risk factors and susceptible people who may become reservoirs or constitute a vehicle of contagion and understand basic protective and barrier measures. the simplest, most effective and universal procedure is hand hygiene. the world health organization identifies five key times for washing: before and after contact with the person, before performing a clean/septic task, after the risk of exposure to body fluids, and after contact with the patient's environment [ ] [ ] [ ] . when hygiene guidelines are given, it is worth noting other times: before, during and after handling or preparing food, before eating, before giving medication, before and after treating a wound or handling clinical devices, after using the bathroom and after handling used clothing, whether personal, bath or bedding, diapers or waste. after washing, it is important to dry the hands. personal hygiene and topical hydration are other prevention strategies. the skin constitutes a natural protective barrier and is particularly labile in the elderly. its daily care guarantees its integrity and protects it from external assault. this includes body hygiene and protective measures aimed at moisture control and injury prevention. some studies highlight the importance of oral hygiene in relation to respiratory diseases [ ] . the great social esteem that existed in ancient cultures for the elder of the group or tribe is well known. he was not only the oldest person but also the biological father, the political leader and, in many cases, the religious authority. and, as anthropologists have pointed out more than once, the "hard disk" of the community, aware of past events of which the younger generations are not, thereby bringing the social group together and giving it its own identity. hence, the elders were not only respected but highly valued and even revered. it is enough to open the books of the bible, for example, to find testimonies of this. its pages over and over again reverential respect for the elder, applying such venerable terms as "patriarch". the bible attributes an extraordinary longevity to the first patriarchs (gen ; , - ), and even to the later patriarchs, like abraham (gen , . ; , ) and moses (dt , ; , ), and to the prophets, it is difficult to represent them as young people. respect leads the bible authors to attribute centuries-long lives to them. longevity is a sign of their wisdom. the so-called wisdom literature bears good witness to this veneration for the elderly. in the book of ecclesiasticus we read: in your youth you did not gather. how will you find anything in your old age? how appropriate is sound judgment in the grey-haired, the contrast between the ancient civilization of israel and the archaic greek culture, as presented in the homeric poems, is surprising. it is difficult to imagine ulysses, hector or achilles as elders, even though in those poems there are also venerable subjects such as menelaus, agamemnon and priam. the contrast between agamemnon and achilles is particularly significant, for the poet paints the former as an ambitious and selfish man, with an excessive ego who confronts achilles, his best warrior, again and again. heroes, those beings that the greeks considered perfect and semi-divine, are by necessity young and in the fullness of their life force. in greek statuary of these institutions, that they are equipped with the appropriate medical, nursing and social services and that a systematic accreditation of these services is achieved. ideally, these centres should have very significant prevention measures in place and should work closely, on the one hand, with the primary care physicians responsible for the patients, and on the other hand, with the reference hospitals to which the patients have to be transferred at some point. elderly associations must continue to work to improve the care of the elderly in emergency departments, not only from a technical point of view, but also by ensuring the agility of the assessment and dignified conditions for the elderly in these departments. finally, the elderly who are hospitalised are patients who require very rapid mobilization, avoidance of exposure to multi-resistant microorganisms and the fastest possible transfer back to where they came from. elderly associations promote the provision of geriatric beds and services in all hospitals, where structures and organisations are set up specifically to serve the needs of elderly patients with a comprehensive idea of their care. as we have mentioned, prevention is better than cure, and in that sense, the elderly associations can play an important role in emphasizing to the authorities, to the groups of affected people and to healthcare personnel the importance of promoting vaccination campaigns [ ] in short, associations for the elderly, whether they are focused on health or not, can play a very positive role that is often overlooked when it comes to improving health. they could work, if possible, promoting and propagating vaccination campaigns. they could also contribute more than they do to other forms of health education, from those oriented towards nutrition or physical activity, to those focused on fighting toxic habits or reporting abuse. all this is of general interest, as well as directly and indirectly affecting the field of infectious pathology. following the recommendations of the expert consensus on frailty in the elderly, active ageing and drug screening in polymedicated patients are important in preventing infections in these patients. elderly associations must play a major role in demanding quality care policies for elderly patients, both in the fields of prevention and treatment. target areas for intervention are the home environment, the outpatient system, nursing homes, hospital emergency departments and hospital care. patient associations can contribute more than they do to other forms of health education, from those oriented towards nutrition or physical activity, to those focusing on combating toxic habits or reporting abuse. what ethical aspects would you highlight in all these problems? modern systems of work organisation have made "efficiency" a major objective of the culture of the second stage of life. there is no doubt that in spain, for example, efficiency has increased three or fourfold in the last half century. and here is the origin of the problem. what do you do when you are no longer "efficient", at least in the way the economy defines efficiency? efficiency is a value that belongs to the category of socalled "instrumental values", "reference values" or "technical values". they are so called as they have no value in themselves, but only in reference to something else or another value. let's think, for example, of a drug. there is no doubt that it has value, at least financially. its most valuable asset is to relieve a symptom or cure a disease. if it wasn't good enough, we'd say "it's not good enough", and we wouldn't pay for it. this means that the value of the drug is in reference to something other than itself, such as well-being, health, life, etc. this happens to all technical instruments. if we were to find a more effective or less expensive drug, there is no doubt that we would choose it, because this is what efficiency is about: the cost/benefit ratio. efficiency is the unit of measurement for instrumental values. the problem is that not everything is instrumental. if they are always in the service of others, it means that these others must stand on their own, otherwise we fall into an infinite regression. these are called "intrinsic values" or "fundamental values". they are the most important in life. they are essential values, values that have worth in their own right, without reference to others. think, for example, of dignity. or many others, such as health, life, beauty, well-being, justice, solidarity, etc. these are all intrinsic values. without them, life is meaningless [ ] . furthermore, they have the characteristic of not being measured in monetary units, nor is efficiency a criterion. "health is priceless" it has always been said; "true love is neither bought nor sold"; "only the foolish confuses value and price" said antonio machado. and the list could go on [ ] . we can now understand the importance of promoting a culture of old age. during our working life there is no doubt that the fundamental criterion must be efficiency, and therefore economy. but that is, at the same time, the least human part of life. the day is not far off when that part of our existence can be transferred to the robots. and the problem arises: what will we humans do then? will we have anything to do? older people have a fundamental mission in our society, and that is to take charge of promoting intrinsic values and passing them on to younger generations. it's not all about economics. it's not all about efficiency. there are other values, which moreover are the most important, the most human. conclusion: promoting a new culture of the elderly should lead us to avoid not only the discrimination that has occurred throughout western culture, and particularly in recent centuries, but also to give impetus to the promotion of intrinsic values, the most humane, the most important in the lives of individuals and societies. this is the very im-it is impossible to see the decrepitude of the elderly person represented. the poet menander coined a sentence that soon became famous and that plautus translated into latin: quem di diligunt, adulescens moritur, "those loved by the gods die young" (bacchides, - ). perfection is in youth, and old age is almost embarrassing. aristotle says that "disease is an acquired old age, old age a natural disease" (gen. an. b . it was important to remember this about the attitude of our culture, the western one, towards the elderly. they've never been held in high esteem. moreover, we can be seen that this esteem has been decreasing over time. this is demonstrated by the words we use to refer to this age group. "viejo" (old) comes from the latin vetus, the opposite of novus, both of which are terms that were designating things, not people. for people, the correct terms were senex and its opposite iuvenis. from senex comes our word "senescence", only used in a very limited sense today. cicero wrote a dialogue de senectute, using the correct term in his language. though, in the various spanish editions that exist, the translation is invariably sobre la vejez. (on old age). old age is not only an improper term, but also a derogatory one. no one sees it that way anymore, because they don't know about this process. but the transition from one term to another is an evident sign of the devaluation that the figure of the elder has undergone in western culture, even though it was originally already much lower than that of other cultures. if we add to this the spectacular increase in life expectancy at birth in the last century, it turns out that this devalued period, which until the beginning of the th century was almost anecdotal in the life of western society (it should be remembered that life expectancy at birth in spain had been stable at - years from the neolithic revolution to the end of the th century), has become a period of no lesser and sometimes greater duration than the active life of a person. so much so that human life today can very well be divided into three -year periods, the first of which is devoted to vocational training, the second to production, and the third.. it is not very clear to what, among other things, because the training we were given in the first years was aimed at being productive in the second phase, but we were never educated for the "third age". the third and final phase of life, which today has an average duration of years, is a continuous source of problems. it is, at least, in the economic order, as the present pension system seems difficult to maintain, and will be impossible in the near future. but, as important as this is, that's not the biggest problem. the most serious issue is that we have condemned the elderly to being a "passive class", whom inserso (the institute for the elderly and social services) has to ferry from one place to another in order to at least distract them. there is talk of discrimination and abuse of the elderly. in my opinion, the greatest discrimination is this, the fact that the elderly have been deprived of their own role in society; or, to put it another way, the total absence of what i have been calling the "third age culture" for some time [ ] . yes, third age culture. the third age has its own culture, distinct from the second age. portant active role that members of the third age have been entrusted with, given that in our culture the second age is obsessively consumed by the promotion of economic efficiency. does this matter for the control of infection in the elderly? as has already been said in previous interventions, the dynamic, active elderly, who feel that they have a mission to fulfil in society, are undoubtedly in a better position to avoid infections and to combat them when they do occur. it is not true that, as aristotle said, old age is a "natural disease". there are many reasons to claim that it is not merely a part of life, but in many ways the most important. and it will be even more so in the future. special considerations for antimicrobial therapy in the elderly fever and aging intraabdominal infection: diagnosis 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different hand-drying methods: a review of the evidence the authors declare that they have no conflict of interest. this publication has been funded by glaxosmithkline. key: cord- -pzv dzow authors: massaad, elie; cherfan, patrick title: social media data analytics on telehealth during the covid- pandemic date: - - journal: cureus doi: . /cureus. sha: doc_id: cord_uid: pzv dzow introduction: physical distancing during the coronavirus covid- pandemic has brought telehealth to the forefront to keep up with patient care amidst an international crisis that is exhausting healthcare resources. understanding and managing health-related concerns resulting from physical distancing measures are of utmost importance. objectives: to describe and analyze the volume, content, and geospatial distribution of tweets associated with telehealth during the covid- pandemic. methods: we inquired twitter public data to access tweets related to telehealth from march , to april , . we analyzed tweets using natural language processing (nlp) and unsupervised learning methods. clustering analysis was performed to classify tweets. geographic tweet distribution was correlated with covid- confirmed cases in the united states. all analyses were carried on the google cloud computing service “google colab” using python libraries (python software foundation). results: a total of , tweets containing the term “telehealth” were retrieved. the most common terms appearing alongside ‘telehealth’ were “covid”, “health”, “care”, “services”, “patients”, and “pandemic”. mental health was the most common health-related topic that appeared in our search reflecting a high need for mental healthcare during the pandemic. similarly, medicare was the most common appearing health plan mirroring the accelerated access to telehealth and change in coverage policies. the geographic distribution of tweets related to telehealth and having a specific location within the united states (n= , ) was significantly associated with the number of confirmed covid- cases reported in each state (p< . ). conclusion: social media activity is an accurate reflection of disease burden during the covid- pandemic. widespread adoption of telehealth-favoring policies is necessary and mostly needed to address mental health problems that may arise in areas of high infection and death rates. the novel coronavirus outbreak that started in wuhan, china entered a new phase after the world health organization (who) officially declared it as a global pandemic on march , [ ] . this called out for urgent changes in the medical sector after presuming hospital- associated transmission in nearly % of infected health professionals and % of hospitalized patients [ ] . telehealth rapidly became a necessary technology to guarantee continuity of care amidst worldwide physical distancing policies, by allowing patients to receive medical care while minimizing the risk of exposure -a critical concern for the elderly and those with chronic conditions [ ] . as the pandemic remains ongoing, urgent action is required to support the digital transformation in healthcare and to understand the various concerns of patients needing care during this crisis [ ] . healthcare workers, patients, institutions, technology industries, and policymakers turned to social media to embrace this rapid shift in healthcare delivery. twitter (twitter, inc., san francisco, ca) has been considered among the best social media platforms for keeping its users on top of the most trending topics and in understanding consumers' opinions on health technology matters [ ] . for this reason, we planned to explore the data available on social media to better characterize the surge in telehealth during the covid- pandemic. our study aims to analyze the dynamics of social media data related to telehealth and understand the public activity to strategically optimize and accelerate the digital health transformation. this cross-sectional study was conducted from march , to april , . this study was exempted from the institutional review board at harvard medical school because the data used are publicly available. in this instance, a consent form was not necessary. this study followed the strengthening the reporting of observational studies in epidemiology (strobe) reporting guidelines. twitter is an online public social media platform that allows users to post -character posts. publicly posted "tweets" from march , to april , , were collected through the public streaming api (application programming interface). full-text tweets were preprocessed by converting the sentences to words (tokenization), removing unnecessary punctuations, tags, and stop words that do not have a specific semantic meaning (i.e. "the", "are"). we applied a stemming function with lexicon normalization to reduce related words to a common word root (i.e. connection, connected, connecting were reduced to "connect"). we isolated tweets with an identifiable location within the united states and constructed a density map. preprocessing was done using the natural language toolkit (nltk) on python . [ ] . descriptive analytics were performed to study the data collected. tweet characteristics included account median number and range of followers. generalized linear regression was performed to study the association between "telehealth" tweets and the number of confirmed covid- infections. statistical significance was set at p< . . unsupervised learning was performed using k-means clustering algorithms to classify tweets into topics. we used the elbow method to define the number of k dimensions where k depends on the number of topics. all data preprocessing, analysis, and visualization were performed on the google cloud computing service "google colab" (colab.research.google.com) using python . programming language (python software foundation; http://www.python.org). our search revealed that the word "telehealth" appeared in , posts on twitter from march , to april , . the retrieved twitter accounts had a median number of followers of (range - ). every post containing the word "telehealth" was retweeted with a median number of two times (range - ). the most common words apart from "telehealth" that appeared in these tweets were "covid", "health", "care", "services", "patients", "pandemic", "coronavirus", "healthcare", "access", "need". mental health was the most common health-related topic that appeared in our search. similarly, medicare was the most common appearing health policy-related topic mirroring the accelerated response to telehealth and the changes in coverage policies. unsupervised machine learning classification of tweets identified six clusters of tweets that contained words mostly related to: ( ) mental health services, ( ) digital health, ( ) policies and advocacies, ( ) hydroxychloroquine, ( ) technology, and ( ) general opinions. in the united states, our analysis showed that tweets were most commonly posted from our analysis revealed an association between the number of tweets related to telehealth posted in a certain state and the number of confirmed covid- cases in that particular state (p< . ) ( figure ). this variable distribution can also be visualized by comparing the density map with the number of tweets to that with the number of confirmed covid- cases in each state. social media platforms have proven to be very engaging with the public [ ] . data analysis of social media content has provided insight into political campaigns, media, healthcare, and daily events [ ] . in this study, we retrieved and analyzed public data available on twitter to investigate the rapid shift in telehealth adoption amidst the recent coronavirus covid- pandemics. our results highlighted the need for widespread implementation of digital health and the importance of favoring policy changes to unleash the power of this technology. interestingly, the number of tweets related to telehealth was associated with the number of covid- cases in each of the u.s. states. moreover, mental health appeared to be the most common health-related issue discussed online. this may refer to the significant effects on mental health in areas of high disease burden [ ] . in fact, efforts to implement telehealth were rapidly mobilized across the united states on many levels. healthcare plans and agencies provided regulatory relief and reimbursement policies to provide telehealth services during this public health emergency [ ] . major medicare and medicaid telehealth policy updates in the states with the highest reported coronavirus positive cases are summarized ( table ) . physical distancing and shelter-in-place orders are likely to result in considerable psychological distress, which prompts healthcare providers and organizations to ensure and sustain a pandemic workforce that addresses crisis-related health problems [ ] . new york -reimbursement for live video -some reimbursement for store-and-forward and home health services telehealth services have rapidly and largely transformed healthcare delivery in areas of high infection rates. in parallel, social media platforms became an immense source of information on day-to-day events and a reflection of social interactions and responses. in this study, we showed that such platforms can be used to assess the needs of our communities and to embrace the healthcare response, resilience, and preparedness during pandemics. nationwide efforts should focus on lifting provisions and scaling up resources to expand digital health implementation to address crisis-related sequelae. human subjects: all authors have confirmed that this study did not involve human participants or tissue. animal subjects: all authors have confirmed that this study did not involve animal subjects or tissue. conflicts of interest: in compliance with the icmje uniform disclosure form, all authors declare the following: payment/services info: all authors have declared that no financial support was received from any organization for the submitted work. financial relationships: all authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. other relationships: all authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. estimating clinical severity of covid- from the transmission dynamics in wuhan, china detection of sars-cov- in different types of clinical specimens covid- and healthcare's digital revolution digital mental health and covid- : using technology today to accelerate the curve on access and quality tomorrow twitter as a tool for health research: a systematic review natural language processing with python: analyzing text with the natural language toolkit heatmaply: an r package for creating interactive cluster heatmaps for online publishing social media and emergency preparedness in response to novel coronavirus us public concerns about the covid- pandemic from results of a survey given via social media addressing the covid- pandemic in populations with serious mental illness securing the safety net and protecting public health during a pandemic: medicaid's response to covid- ensuring and sustaining a pandemic workforce key: cord- -ke iktly authors: chew, alton ming kai; ong, ryan; lei, hsien-hsien; rajendram, mallika; k v, grisan; verma, swapna k.; fung, daniel shuen sheng; leong, joseph jern-yi; gunasekeran, dinesh visva title: digital health solutions for mental health disorders during covid- date: - - journal: front psychiatry doi: . /fpsyt. . sha: doc_id: cord_uid: ke iktly nan the coronavirus disease (covid- ) pandemic has had an immense impact infecting million individuals and claiming , lives globally as of july ( ) . the rapid spread was largely enabled by the onset of the outbreak in wuhan city just prior to the lunar new year season, a peak period in travel to and from china ( ) . fortunately, many regions have controlled initial outbreaks and shared their experiences. these have been recently summarized by the world health organization (who), highlighting the importance of developing targeted responses and enhancing communication to address the pandemic's impact ( , ) . notably, emotionally driven sharing of misinformation has featured prominently in this crisis, fueling both confusion and irrational anxiety among the public ( , ) . termed an "infodemic", this has far-reaching consequences on population health with a direct impact on overloaded health systems and an indirect impact on mental health, resulting in paranoia and behavioral responses like stock-piling due to disproportionate fear ( ) . the impact of misinformation in the media on public emotion and fear has been illustrated with the middle-east respiratory syndrome (mers), whereby it led to a surge in fear and sustained economic consequences ( ) . the psychosocial impact of large-scale disasters and previous outbreaks have been described, including increased incidence of mental health disorders ( ) . similarly, covid- has had a twofold detrimental impact on the mental health of populations subject to the psychosocial consequences of the pandemic, including the incidence of new onset mental health disorders as well as deterioration in the condition of patients with existing mental health disorders ( , ) . this impact is on the rise given the protracted lock downs, social isolation, and concomitant occupational stressors in the context of the weakened global economy ( ) ( ) ( ) . these factors highlight the urgent need to scale-up and decentralize mental health services to attain a multiplier effect in the provision and accessibility of these services to combat the pandemic-driven surge in mental health disorders ( , ) . fortunately, several reports have demonstrated the effectiveness of digital health solutions for various applications, including addressing gaps in mental health services ( ) . these solutions include cloud-based big data systems, artificial intelligence (ai)based chatbots, online health communities (ohcs), and telehealth platforms. several have already been extensively applied for the pandemic's direct impact on health, such as big data systems and telehealth for remote consultations ( , ) . this review summarizes relevant applications of digital health that can help address the indirect impact of the pandemic on population mental health. cloud-based big data systems have been successfully applied in previous infectious disease outbreaks by aggregating data from numerous possible sources including weather surveillance systems ( ) , queries in online search engines ( ) , and even connected devices among the internet of things (iot) such as mobile phones and drones ( , ) . applications of these systems range from early detection of outbreaks to facilitating global digital epidemiology collaborations that address unresolved clinical uncertainties, such as ocular findings for early detection of latent tuberculosis ( , ) . successful applications include monitoring dengue outbreaks using data on mobility from mobile phones ( ) or queries in search engines such as baidu in china ( ) . evidence is emerging for the value of these platforms beyond retrospective or real-time surveillance applications, to prospective projections of disease trends and clinical need. in the context of the ongoing pandemic, several potential applications of these tools have emerged, such as predicting outbreaks of covid- based on historic travel data and public health capacity ( ) . also, cornelia betsch and the covid- snapshot monitoring (cosmo) group evaluated methods for surveillance of behavioral responses to the pandemic ( ). these applications enable evidence-based approaches to localize public health responses and monitor their effectiveness, in accordance with who recommendations ( ) . related applications for mental health include the prediction of disorders such as depression, stress and anxiety, using publicly available data from websites like twitter ( ) . these applications are gaining traction in academic consciousness as digital data becomes more ubiquitous, as exemplified by the development of recommendations for evidence-based research using tools like google search to predict mental disorders ( , ) . there are also validated individual-level applications of big data, such as the use of ecological momentary assessment (ema) from passive behavioral monitoring of mobile data, that have been used to detect and monitor severity for a spectrum of mood and behavioral disorders ( ) . this ushers in the possibility of precision digital mental health with tailored recommendations to the individual, as recently described for panic disorder ( ) . these methods can be leveraged for useful applications during lockdowns, such as early detection of mental health disease onset or progression. however, unresolved barriers to implementation include ethical and privacy issues of populationlevel monitoring such as with big data systems for contact tracing, that would similarly apply to systems for mental health surveillance ( ) . measures to facilitate implementation include the use of high quality input data and clinical validation using formal diagnostic criteria, robust methodology, and actionable outcomes ( ) . nonetheless, these systems can contribute to responses to the pandemic and address the needs of the vulnerable groups during the recurrent lockdowns in response to local outbreaks, such as potential victims of domestic violence ( ) . ai chatbots utilize pre-programmed content and decision-trees for automated conversations using techniques such as natural language processing (nlp). these are more interactive than static digital repositories leading to higher engagement for patients ( ) . preliminary reports of ai chatbots that have been developed for mental health include solutions providing counseling for well individuals to improve psychological wellbeing ( ) . others include ai chatbots such as wysa for digital mental well-being with demonstrated effectiveness in patients with depression ( ), and woebot for cognitive behavioral therapy (cbt) in young adults with depression/anxiety symptoms ( ) . these tools have potential applications in the current pandemic and beyond for preventive care and mental health promotion. they also function as contingency solutions to expand surge capacity in the event of overwhelming clinical need ( ) . however, their applications needs to be supervised given limited clinical validation with robust experimental design ( ) . other challenges clinical ai have also been described in various specialities, including practical, technical, and sociocultural barriers to implementation ( , ) . particularly given the conversational nature of chatbots and linguistic variations in different populations, acculturation is needed to facilitate the implementation of chatbots in new populations, as demonstrated with ai chatbots for health professional training to address colloquialisms such as "singlish" in singapore ( ) . this is crucial to ensure emotional support or triage advice are perceived accurately by patients, and piloting messages will help ascertain effectiveness ( ) . validated community mental health assessment tools could be incorporated in future conversational ai chatbots to prompt regular self-reporting by patients of wellness and social inclusion for active population monitoring. these include the various iterations of the social and communities opportunities profile (scope) scale validated in the united kingdom and hong kong, as well as the mini-scope in singapore ( ) . applying ai chatbots in this manner using a "sorting conveyor" operational model could be transformative, whereby the ai solutions built with predefined criteria can re-direct individuals requiring more comprehensive psychological support to appropriate services within a stepped-care mental health service ( ) . open digital patient engagement platforms that allow any visitor to a website or application to view interactions between patients and/or healthcare providers are called online health communities (ohcs). ohcs could be the silver bullet to the "infodemic", which is largely attributed to the unfettered spread of viral misinformation in unverified sources or platforms like social media, crowding out official communication ( , ) . in the earlier example of the impact of misinformation on fear during mers, choi et al. found that it created a positive feedback loop leading to a spiral of growing misinformation and paranoia, with the publication of more inaccurate information by the media in a bid to capitalize on public interest ( ) . big data systems such as the aforementioned cosmo for behavioral surveillance provide measures of these phenomena to develop targeted public health communication messages-an essential first step to combat this problem ( ) . however, due to the speed of misinformation propagated online, there is increasingly a need to implement a digital effector arm for our monitoring systems ( ), one that amplifies reputable sources to directly combat misinformation in a transparent, scalable manner by addressing myths and promoting reputable sources of information ( ) . in singapore, such a solution was developed by askdr through needs-finding surveys and ideation with frontline providers (figure ). it combines network effects of social media with behavioral gamification to give registered medical professionals digital tools to crowd-source a coherent counter-narrative to misinformation ( ) . public health agencies should similarly develop or adopt such tools for the "last mile" of public health communication. in the context of the ongoing pandemic, key applications include promoting reliable information and directly breaking the "spiral of misinformation". direct potential applications of ohcs for patients at-risk of mental health disorders include lowering the barrier to access care and support for stigmatized illnesses such as anxiety and depression, by allowing patients to seek initial medical advice anonymously ( ) . apart from the provision of basic demographic information such as gender and age that are required to contextualize medical advice; otherwise, anonymous engagement also helps to address limitations such as privacy issues similar to those with big data systems ( ) . other applications of ohcs that can enhance public health responses to the pandemic include provision of triage advice to optimize right-siting of patients and reduce unnecessary healthcare presentations where appropriate. this "tele-support" can be used long-term for fundamental illness-related concerns that may not require formal consultation, such as questions about potential interactions of chronic medications with overthe-counter (otc) medications or other health products ( ) . finally, they provide an avenue for asynchronous patient engagement between outpatient appointments while protecting the privacy of healthcare providers, creating opportunities for patient support and early identification of at-risk individuals needing to be re-directed to formal mental health services online or in-person ( ). digital telehealth services have numerous embodiments including video-conferencing, store-and-forward technology, remote tele-monitoring with connected devices, and mobile health applications, all of which are increasingly applied in large-scale disasters ( ) . these can be used for either asynchronous or synchronous consultations with private discussions between patients and healthcare providers ( ) . existing descriptions of tele-mental health services indicate the importance of human support and interaction regardless of the embodiment of telehealth used ( , ) . although its application in covid- for mental health services has been greatly enabled by legislative changes ( ), the barriers to telehealth adoption that have kept it from becoming mainstream to date still remain ( ) . ensuring successful, sustained adoption requires active alignment with clinical needs when deploying services ( ) . nonetheless, tele-mental health services are critical to maintain the continuity of care for patients with mental health disorders by providing avenues for remote review and prescription re-fills ( ) . other avenues with long-term value to health systems include co-ordinated avenues for health professionals to engage patients with mental health disorders more frequently, facilitate early detection of those at-risk of selfharm, and enable preventive interventions such as motivational interviewing that reduce hospitalizations ( , , ) . apart from the traditional two-way teleconsultation between doctor and patient, multi-way conferencing or tele-collaboration by allied professionals remotely supported by clinicians has been described ( ) and is mainstreamed in countries like singapore to project tertiary care to nursing homes and intermediate and long-term care (iltc) facilities. covid- is the first "viral" pandemic that threatens to overwhelm mental health services in coming months as a result of fear perpetuated by misinformation alongside social isolation during lockdowns ( , ) these unprecedented challenges highlight the need to develop creative solutions to address the impending surge in mental health disorders ( , ) . the four technologies discussed in this review are potential avenues to expand the capacity and penetration of existing mental health services to address this indirect health impact of the pandemic. hybrid strategies combing various solutions in an overarching "pyramid" operational model may be required to rapidly scale-up stepped mental health services. this was illustrated in the saved study operationalizing telehealth for complexed emergency services ( ) . digital operationalization of mental health services can be similarly achieved using combinations of digital tools in comprehensive services such as illness management and recovery (imr) programs ( ) . imrs are structured mental health services incorporating multi-modal mental health interventions to promote self-management and optimize treatment. pioneered in america, they were externally validated and demonstrated to reduce readmissions and the post-illness recovery period of asian patients after discharge from in-patient psychiatric services ( ) . the pyramid base catering to the needs of the general population could include screening tools such as big data systems and/or ohcs to actively identify and/or engage at-risk individuals without pre-existing mental health disorders, as well as provide tele-support services to reduce risk of progression in patients with mental health disorders ( ) . as countries re-open, at-risk individuals can be directed to ai-based chatbots providing automated support as well as triage in a "sorting conveyor" operational model to further escalate care as appropriate to inperson or telehealth mental health services based on patient risk profile ( , ) . these requires modifications to traditional practice as described for telehealth cognitive processing therapy (cpt) services to treat post-traumatic stress disorder (ptsd), a condition likely to increase in coming months even among healthcare professionals due to the prolonged stress of frontline services or rationalizing care in some regions ( , ) . ultimately, the effective deployment of digital mental health services is greatly dependant on successful assimilation within existing health systems. patient willingness to use, provider acceptance, and even the quality of digital and hardware infrastructure are fundamental considerations that need to be addressed. this has been recently illustrated based on the challenges of implementing ai solutions for ophthalmology despite maturity of the technology ( , ) . deployment of digital health thereby needs to be driven by the needs of the target patient population, clinical acceptance, and validated effective applications ( ) . these considerations dictate the likely effective form of deployment for these digital tools. designing effective digital mental health care requires taking into account the wide range of patient needs determined by the severity of mental health disorder(s), social determinants of health (sdh), access to technology, and cultural acceptance, among others ( , ) . there is no "one size fits all" solution, and research in telehealth has demonstrated that individualized design considerations are critical to maximize acceptance, ensure effectiveness, and sustain adoption with recurrent use ( ) . meeting the needs of patients in a timely and cost-effective manner ensures sustained adoption beyond the covid- crisis. for provider adoption, stakeholder engagement methods have been advocated to map out clinical processes, participants, and individual responsibilities to actively plan deployment for telehealth ( ) and are just as important for other forms of digital health ( ) . firstly, this requires detailed mapping of the needs, roles, and incentives of stakeholders such as healthcare workers, logistic procurement teams, and chief medical informatics officers. they are prioritized into primary and secondary stakeholders based on their capacity to make or influence decisions about adoption of digital tools. subsequently, a deployment strategy is developed to maximize stakeholder alignment while minimizing disruption to existing processes or new responsibilities that may overburden stakeholders. this also yields crucial insights for communication strategies to engage individual stakeholder groups effectively. participatory approaches like these with design-thinking have been used to operationalize tele-health in complexed emergency services ( ), as well as develop solutions with targeted applications such as ai chatbots for automated adolescent mental health coaching ( ) . in tandem, it is important to address the needs of vulnerable populations that may fail to seek care, such as potential domestic violence or child abuse victims ( ) . they may require tailored solutions such as targeted deployment of mobile mental health services provided by allied mental health professionals that could be remotely advised by psychiatrists using "hub-and-spoke" telehealth to project services into these pockets of society. in conclusion, the massive health impact of the first "viral" pandemic has been fueled by global travel, social isolation, rampant misinformation in social media, and other intricacies of modern life. however, digital mental health tools are the silver lining we are fortunate to have, as they can empower responses to the covid- outbreak at a scale that was never before possible in human history. responding effectively to the mounting impact of this pandemic on population mental health may ultimately require us to leverage these digital health solutions to expand the capacity of mental health services and supplement face-to-face care with an intentional approach for successful deployment ( , ) . authors ac and ro are medical students on clinical research attachment with author dg. author h-hl is an adjunct associate professor at the saw swee hock school of public health (sshsph), nus, and concurrently chief executive officer, the american chamber of commerce in singapore. author rm is a tutor in academic english at the center for english language communication (celc), nus. author gk is a senior operational manager at the institute of mental health (imh), singapore. authors sv, df, and jj-yl are senior consultant psychiatrists at imh, singapore. author sv is also a professor at duke-nus, singapore. the author df is also the chairman medical board at imh, singapore, as well as president of the international association of child and adolescent psychiatry. df is concurrently adjunct associate professor at all three medical schools in singapore, nus, duke-nus, and 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study was to identify which telehealth and digital technology tools are used by cps for public health purposes and determine if these have a positive impact on public health outcomes. a systematic review was carried out using databases including pubmed and sciencedirect, covering a time period from april until april . the search criteria were the following: randomized controlled trials, published in english, investigating the delivery of public health services by community pharmacists using a telehealth or digital tool. thirteen studies were included out of initially identified. nine studies detailed the use of telephone prompts or calls, one study detailed the use of a mobile health application, two studies detailed the use of a remote monitoring device, and one study detailed the use of photo-aging software. public health topics that were addressed included vaccination uptake (n = ), smoking cessation (n = ), hypertension management (n = ), and medication adherence and counseling (n = ). more studies are needed to demonstrate whether or not the use of novel technology by cps can improve public health. at a time when the world is in the midst of a global pandemic [ ], community pharmacists need to adapt to a "new normal" in which human-to-human contact between them and their patients/customers can be limited [ ] . new approaches to communication and service delivery are needed to keep community pharmacy teams and the public safe from a virus that has no known vaccine and whose long-term impact on society is not yet known [ , ] . although, currently, the focus for community pharmacy is to deal with the pandemic, there may come a time, in the near future, when the pressures of this subside, and then community pharmacists will need to consider how they continue to deliver public health interventions that deliver positive health outcomes, but in an era of continued social distancing [ ] . there are different settings in which pharmacists operate, such as in a community, in a hospital, and in industry; however, for the purposes of this article, the terms pharmacy and pharmacist refer to the community arm of the profession. in addition to the immediate public health concerns of the coronavirus, other important global health issues still remain, including both communicable (e.g., hiv, tuberculosis, malaria, and hepatitis) and noncommunicable diseases. according to the world health organization's (who) global report on causes of deaths [ ] , six of the top ten causes of death were from noncommunicable diseases to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions" [ ] . in layman's terms it describes a member of the public's ability to interpret the health information that they are given, and then apply it to their own lives while digital literacy, as defined by gilster in [ ] , is, " . . . the ability to understand and to use information from a variety of digital sources . . . [it is] literacy in the digital age." of interest, a study [ ] highlighted that those with low health literacy were also less likely to use digital health tools or to find them easy to use, indicating that these concepts can be linked, and can even increase the incidence of health inequalities. as a result, it is important that healthcare professionals, including pharmacists, not only consider the health literacy but also the digital literacy of their patients and customers. in addition, it is important that healthcare professionals develop their own digital literacy skills so that they can support their patients and customers to reap the benefits of technological advances to improve their health. a systematic review raised concerns about regarding pharmacies supporting the digital training of their workforce [ ] . this review highlighted that while a pharmacy is using technology on a daily basis it does not appear to have adapted a structured training approach or development standards for its workforce. this raises concerns, that is, while the public are embracing novel technology and turning to it for health and wellbeing advice, the use of technology by pharmacists and its impact on the health of those who interact with pharmacists is still unknown [ ] . there is risk that the profession could being left behind, and would no longer be deemed to be the most accessible healthcare professional, as we are now. therefore, we conducted a systematic review of the literature to understand how pharmacists have used telehealth and digital technologies to improve public health related outcomes, addressing ncds as well as communicable diseases and medication-related topics. this systematic review was carried out following the recommendations of the preferred reporting items for systematic reviews and meta-analyses (prisma) statement [ ] . the review was carried out between march and may to identify any papers published between april and the end of april . pubmed, medline, science direct, web of science, and scopus were searched for articles that reported outcomes associated with the use of telecommunication or digital communication technologies by pharmacists for the purposes of improving public health. medical subject heading (mesh) terms and keywords (kw) were identified and a search strategy was developed using the pico (population, intervention, comparator, outcome) framework. mesh terms and kws for community pharmacy included pharmacy (mesh), pharmacies (mesh), community pharmacy services (mesh), and retail pharmacy (kw). mesh terms and kws for telecommunicaitons and digital communication technology included telephone (mesh), social media (mesh), mobile applications (mesh), internet (mesh), facebook (kw), twitter (kw), instagram (kw), and youtube (kw). mesh terms and kws for public health interventions and outcomes included public health (mesh), smoking cessation (mesh), weight-loss (mesh), health (mesh), sexual health (mesh), and alcohol brief intervention (kw). the full pico search criteria used on pubmed is available in supplementary materials. paper references were used to find additional studies, as was google scholar and the authors' institutes own library search engine. for this systematic review, we included the following studies that were: ( ) randomized controlled trials (rcts); ( ) full articles published in peer-reviewed journals; ( ) included a telehealth or digital technology element used for either interaction between a community pharmacist and customer/patient, such as telephone, email, online discussion boards, social media, smartphone mobile application, or for patient use alone as part of a community pharmacy intervention; and ( ) reported public health interventions and outcomes. the authors (p.c. and r.k.) identified studies' titles that suggested that they met the inclusion criteria of the review. further to the initial screening, abstracts and full articles were reviewed and removed if the primary objectives of the paper did not investigate the use of telehealth and digital technologies by community pharmacists for public health purposes and were not run as rcts. a template was created in excel, which both authors used to extract data including intervention variables (location of intervention and recruitment criteria, topic of delivered public health intervention, type of telecommunication or digital communication technology used, and duration of the intervention), participant variables (mean age, gender, and ethnicity), outcomes variables (e.g., quit smoking rates, reduction in weight, reduction in alcohol consumption, and treatment of a sexual transmitted disease). face-to-face meetings were conducted between the authors to compare each other's identified studies. the jadad scale [ ] , which gives each study a score out of a total of based on the degree of randomization, blinding, and withdrawal/drop-out was used to assess the methodological quality of the reviewed rcts. a study with a low risk of methodological bias was given a score of or more, while a study with a high risk of methodological bias was given a score of or . a moderate risk of methodological bias prompted a score of or . in addition, cochrane's risk of bias (rob ) tool was also used to assess the risk of bias in the reviewed randomized trials [ ] . the rob tool gives an overall risk of bias related to bias in the following five domains: randomization, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result. rcts are graded as low risk, some concerns, or high risk based on the combined grading of the five different domains. ethical approval was not required for this study. using the criteria outlined, the initial search identified potential papers. duplicates were removed, and then papers were quickly screened by title. articles not meeting the eligibility criteria were removed. this left potential papers. articles were, then, screened by abstract for inclusion criteria, and then the remaining articles were screened as full articles for inclusion. in total, studies were included in this review. the search process is outlined in figure and the studies used as part of the review are summarized in table . the studies were conducted around the world, including the usa (n = ), [ ] [ ] [ ] [ ] [ ] [ ] [ ] the uk (n = ) [ ] , australia (n = ) [ ] , the netherlands (n = ) [ ] [ ] [ ] , and canada (n = ) [ ] . public health topics addressed in the studies included vaccination rates [ , ] , smoking cessation [ ] , medication adherence [ , , , , , , ] , medication counseling [ ] , and hypertension management [ , ] . the majority of the studies used telephones as their intervention tool [ ] [ ] [ ] [ ] , , [ ] [ ] [ ] while only one study used an mhealth app [ ] , two studies used a tele-monitoring device [ , ] and one study used photo-aging software [ ] . despite smartphones now including video conferencing features, none of the reviewed studies employed this technology. in the intervention group, vaccinations were administered to the study participants. in the control group, vaccinations were administered. this accounted for vaccination rates of . % and . % for intervention and control groups respecitvely. this was not a significant differrence. only . % of intervention participants listened to the full telephone call. of those who did, they were more likely to get vaccinated than controls. participants: adults aged over years old who were scheduled to have an automated telephone call from their community pharmay, e.g., to remind them to refill their medication intervention: participants received an additional prompt within the call and were offered either pneumococcal or hz vaccine or both, depending on their vaccination record. three call attempts were made in total. control: received their scheduled automated telephone call but without the additional vaccination offer. year the number of successful smoking quit attempts, confirmed by carbon monoxide (co) breath test, measured at , and month follow-ups. in addition, nicotine dependence was measured via the fagerström scale ( . %) of intervention group were non-smokers at months vs ( . %) of control group (p = . ). this was significant and confirmed by co monitor. change in fagerström score from baseline at months was − . for control group and − . for intervention group. % of the control group moved to a lower category of the fagerström score versus % of the intervention group (p < . ) participants: adults aged - years old, who were smokers, without facial hair, who did not suffer from body dysmorphia and who did not take nicotine replacement therapy or medication for nicotine dependence. intervention: participants received min of smoking cessation advice from a pharmacist. in addition, face aging software, april, was used to create aged images of faces from a digital photograph. in addition to the using the normal wrinkling algorithm, the images were also adjusted to compare how participants would age as a smoker versus as a non-smoker. control: participants received min of smoking cessation advice from a pharmacist medication adherence rickles et al. ( ) [ ] usa -months telephone call i = c = the number of times study patients spoke to their pharmacist about their new medication (whether during intervention call or when visiting the pharmacy). in addition, changes in patient knowledge, beliefs, adherence, and depression symptoms at and months. the intervention had a significant and positive effect on the number of times patients spoke to their pharmacist about their new medication (p < . ). in addition, patient knowledge, medication beliefs, and perceptions of progress were significantly better in the intervention group (p < . ). no significant difference was noted in adherence, however, fewer doses were missed in the intervention group. no significant difference was noted in depressive symptoms. participants: adults aged over years old on a newly prescribed antidepressant (within the previous months before recruitment). intervention: participants were telephoned by their pharmacist and taken through pharmacist-guided education and monitoring (pgem). this involved three phone calls at monthly intervals, the first lasted min and assessed medication related issues and education. the second and third calls lasted min each and checked progress with medication and helped with problem management. control: usual care that pharmacists typically provide for patients on new medications. the number of drug-related problems participants reported. in addition, the number and severity of infection symptoms following start of antibiotic treatment. patient adherence to treatment, as well as patient satisfaction. % of intervention participants reported drug related problems versus only % in the control arm (p < . ). these were mostly noted on the phone call and included adverse drug reactions and drug interactions. differences in the number of infectious symptoms and severity of symptoms between control and intervention group were small and not significant. adherence to treatment and satisfaction did not differ across the groups. participants: adult patients with a new prescription for oral antibiotic treatment, whose treatment would last between and days, and who had access to a telephone. participants had a private consultation with the pharmacist about their antibiotic, potential side effects, and adherence to treatment. intervention: referred to the pharmacist telephone follow-up intervention (ptfi). patient received a phone call from their pharmacist on day of antibiotic treatment to discuss treatment, side effects, adherence and any questions they had. control: usual care. afer intial private consultation patients were invited to contact pharmacist, if needed. not stated the primary outcome was the number of days from the date that a patient was declared at least days overdue to the date of the next prescription refill. there were no significant differences in primary outcomes by treatment arm. pharmacists contacted % of those patients in the phone patient intervention. of those, . % stated that they were waiting to switch to another medication and . % stated that they were planning to stop the medication. participants: patients who were at least days overdue for a medication used to treat a chronic disease (diabetes, hypertension, hyperlipidaemia, heart failure, depression, and psychosis). usual care: prescriptions were filled when requested by patients. phone patient (p) intervention: pharmacist reminded patient that they were overdue picking up medications, asked why they were overdue, reminded the patient of the importance of taking medications regularly and helped the patient to overcome barriers. fax physician (f) intervention: pharmacist faxed prescriber with information about patients overdue collecting medication and asked them to return patient disposition codes via fax to the pharmacy. year significant improvement in medication adherence in intervention group, based on mpr ratio. the impact was particularly noticed in those participants who had a baseline mpr of . or less. mpr significantly improved in intervention group at months (p = . ) some concerns participants: adults over -years old on at least one oral prescription diabetes medication who were late for refills. intervention: participants were contacted by their pharmacist by telephone and guided through the a's (ask, advise, assist and arrange), a model used successfully for changing behaviour in smoking cessation. the pharmacist asked if the patient's medication had run out, why they had been late to order their medication, if they were having any challenges with their medication, and to discuss a self-management plan. a follow-up call occurred between week and month later. control: pharmacist discussed ahderence and ordering medication on time at in-person medication refill collections. kooij adherence of patients who previously had poor adherence increased in intervention group; adherence rates in control group decreased (p = . ). no significant difference observed between intervention and control groups on asthma control (p > . ) or quality of life (p > . ). participants: asthma patients aged between - years old, who own a smartphone and have filled at least two prescriptions for inhaled corticosteroids or combination steroid with bronchodilator inhaler in the previous months intervention: usual care (as described in the control) plus months access to the adapt intervention. adapt is a smartphone application connected to software in the patients community pharmacy. the application targeted non-adherent behaviours. the pharmacist could control its settings, review patient use of the application and chat with the patient. control: usual care, meaning that patients received instruction on how to use inhaler at first dispensing, and automated system to detect underuse of inhaled corticosteroid or overuse of bronchodilator. to determine the self-reported adherence or non-adherence to medication at weeks and weeks follow-up. adherence was assessed by telephone and was defined as missing medication without agreement with a medical professional in the previous days. ( . %) out of the who could be contacted at weeks were adherent in the intervention arm versus . % ( / who could be contacted) in the control arm (p = . )-significant difference. at week , . % in the intervention group were adherentas compared with the . % in the control group (p = . )-no significant difference. therefore, statistical difference in adherence between groups was lost after week . participants: patients aged years old and over who phsyically present in the pharmacy with a prescription for a new medicine for a predefined long-term medical condition. intervention: the intervention comprises of a two parts that can be carried out either face-to-face or over the telephone. the first "intervention" happens - days after the first one-to-one consulation. the "follow-up" then happens - days after that. the pharmacist will ask about adherence at these meetings. the whole process should be covered within a maximum of weeks. control: the pharmacists usual advice when a patient presents with a prescription for a new medicine. no follow-up was offered. only of the patients in the intervention arm actually received telephone counseling. some reasons for not providing counseling included: patient could not be contacted and patient refusal. usual care participants' satisfaction with counseling was % versus % in intervention group who received counseling. men were more likely to prefer telephone counseling than women (p < . ). % said telephone counseling had an added value. particiapnts: adults aged years or older who filled a first time prescription for an antidepressant, a bisphosphonate, an antilipaemic, or a renin-angiotensin-system (ras) inhibitor. intervention: usual care (as defined below) plus telephone counseling by a pharmacist. telephone call covered actual intake of medication, barriers to medication use, and information needs about medication. pharmacist used the health belief model (hbm) to direct the counseling. usual care: dutch guidelines on counselling for a first prescription of a new medication. covers an exploration of the patient's needs and experiences with medication. intervention: patients receievd a home bp monitor that stored and transmitted their readings to a website accessible by pharmacist. pharmacists met them for h initially to discuss bp management and goal setting. patients submitted at least weekly bp measurements. during the first months, pharmacists and patients had telephone calls every two weeks until bp controlled for weeks, then calls became monthly. from months - the phone calls were every two months. after months, the bp monitor was returned. pharmacist telephone calls discussed lifestyle, medication adherence, and goal setting. treatment intensification recommended in some instances. control: management of bp by a physician and referral to pharmacist for medication therapy management when needed. the main types of teledigital health interventions and outcomes found in this review were medication adherence and counseling, hypertension management, vaccination uptake, and smoking cessation. most of the reviewed studies showed a positive impact of the use of telehealth and digital health tools, such as telephones and mobile health applications, on participants' health outcomes. two studies [ , ] , both based in the usa, investigated the use of interventions to increase vaccination uptake rates and both used automated telephonic prompts versus usual care. one of the studies showed a significant increase in the uptake of the herpes zoster vaccination in the intervention group, whereas the other study, looking at pneumococcal and herpes zoster vaccination uptake, did not see differences between the intervention and control groups. of note, in the study where no differences in uptake were found, only . % of participants listened fully to the first telephonic prompt. those who did listen to the full call were more likely to have a vaccination administered. one study, based in australia, investigated how photo-aging software could be used by community pharmacists to promote smoking cessation [ ] . participants were shown images of how they would look as an older person if they were to continue smoking or to quit. there was a significantly higher quit rate at months among those who had used the photo-aging software vs. the usual care group. in addition, those in the intervention group showed lower levels of dependence on nicotine by the end of the study as measured by fagerström score (p < . ). seven studies investigated the impact of telehealth or digital interventions by community pharmacists to improve medication adherence [ , , , , , , ] . one was based in the uk, three in the usa, two in the netherlands, and one in canada. the uk, usa, canadian, and one of the netherlands [ ] studies used telephone calls as the intervention tool while the other netherlands study [ ] used an mhealth app. the uk study investigated the uk advanced pharmacy service, the new medicine service (nms), a service in which patients with certain chronic health conditions are supported when newly prescribed medications as a means to improve adherence [ ] . an initial feasibility study had indicated that a telephone-based pharmacy advisory service had a significant impact in reducing non-adherence to medication [ ] , however, the follow-up study suggested that this difference was lost after weeks [ ] . the usa studies investigated patient adherence to antidepressants [ ] and medication for chronic health conditions [ , ] . one of the usa studies [ ] showed a significant improvement in patient adherence to medication for type diabetes whilst the antidepressant study showed an increase in patient knowledge and medication beliefs, but not an improvement in adherence. the canadian study looked specifically at antibiotic counseling with patients in the intervention group being telephoned by the pharmacist on day three of their antibiotic therapy [ ] . the telephone intervention was deemed to have been effective in identifying and managing drug related problems but did not have an impact on adherence or severity of infection symptoms versus the usual care group. the earlier of the netherlands' studies [ ] investigated medication adherence to antidepressants, bisphosphonates, statins, or renin-angiotensin-system (ras) inhibitors in patients taking these medications for the first time. the study demonstrated that adherence to ras inhibitors was improved through telephone counseling, however, this effect was not noted for antidepressant therapy. the later netherland's study used an mhealth app to improve adherence in adolescent asthmatics [ ] . the study showed that the mhealth app had a statistically positive effect on medication adherence (p = . ) but did not affect patient quality of life or asthma control [ ] . the medication counseling study was carried out in the netherlands [ ] and was a pre-cursor to a medication adherence study described above [ ] . while the study was ultimately interested in medication adherence, adherence was not one of the measured outcomes. instead, the authors felt that it was more important to, " . . . assess the impact on the pathway that ultimately leads to adherent behavior" [ ] and so they assessed the effect of telephone counseling on general satisfaction with counseling, satisfaction with information and beliefs about medicines. the majority of patients in the study stated that the telephone call had added value, however, there were no differences in patient satisfaction with the information provided versus usual care. two studies (initial and follow-up), based in the usa, investigated the use of home blood pressure telemonitoring with community pharmacist management [ , ] . patients measured their bp on a monitor that then transmitted this reading to the pharmacist. the pharmacist then called the patient to discuss medication adherence as well as lifestyle and treatment issues. there were significant improvements in bp control for the intervention group at months ( . % controlled, (p < . )), months ( . % controlled, (p = . )), and months ( . % controlled, (p = . )) and the intervention was noted to have sustained effects for at least months. the intervention group sustained significantly lower sbp and dbp versus control group for months from baseline. the jadad tool (see supplementary) indicated that while all of the reviewed studies were randomized, and included details about the method of randomization, only one study [ ] was double-blinded. the same study was also the only one to describe withdrawals/dropouts. the median score was two, indicating a moderate risk of methodological bias for the studies in the review. in fact, all but two of the studies reviewed were deemed to have a moderate risk of methodological bias [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] . the remaining studies were deemed to have a low risk of methodological bias [ , ] . the cochrane rob- tool highlighted that two of the reviewed studies had a low risk of bias [ , ] , while the remaining studies all had "some concerns" in relation to their risk of bias [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] (see table ). missing outcome data and measurement of the outcome were the domains that raised the risk of bias in the studies [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] . this systematic review of rcts evaluating the use of telehealth and digital technology by community pharmacists to improve public health has identified a number of studies that demonstrated the effective use of these tools. the telephone was found to be the most commonly used intervention tool. of note, no studies used social media as an intervention tool. these findings match those of a previous review which highlighted that there was very little evidence of measurable health outcomes following the use of social media, in particular, by community pharmacists to improve public health [ ] . the use of telehealth and digital technology by community pharmacists is not a new research area [ , , , , ] , however, there are very few rcts showing demonstrable impacts on participants' health outcomes. rather, research appears to be anecdotal detailing pharmacists and patients' perceptions and opinions about their use of these tools [ , , , , ] . by bringing together all of the rcts, it is possible to identify successes to date and discuss how telehealth and digital technology could be utilized more effectively in the future. the lack of use of video conferencing technology is interesting; however, one study that did not meet the inclusion criteria for this review did show promise in the use of video conferencing software [ ] . video conferencing was used to support those on multiple medications by offering an opportunity to identify medication-related problems (mrp) and provide patient education. patient satisfaction with the technology was noted to be high and pharmacists found the technology straightforward to use [ ] . benefits that could be achieved with video conferencing include face-to-face discussions to allow the pharmacist to view patient/customer body language as a way of determining health, an opportunity for the pharmacist to demonstrate particular behaviors to educate patients/customers, and as a way to build a trusting relationship between the pharmacist and the patient/customer. another point highlighted in this review was the limited use of "novel" technology by community pharmacists. a mobile health application was only used in one study [ ] , whereas social media was not used in any study. factors relating to the digital literacy of the pharmacy workforce could be a key issue holding back the use of these tools [ ] . a number of studies have highlighted that while many within the pharmacy workforce had high levels of digital literacy, most did not use technology in their work life [ ] . those who used these tools in their personal life were more likely to use them in their work life, but factors relating to concerns about confidentiality and privacy prevented them from using them more [ ] . the public health topics for which pharmacists used telehealth or digital technology in studies in this review were limited in scope. many topics focused on medication counseling and adherence which are more traditional roles of the community pharmacist [ , , , , [ ] [ ] [ ] [ ] . there were only five studies that addressed public health topics with the main outcomes being unrelated to medication adherence or counseling [ , , , , ] . the other topics addressed were vaccination uptake, smoking cessation, and hypertension management. given that community pharmacists deliver public health interventions including weight management, sexual health, and alcohol use, among others, it is surprising that no studies addressed these important and relevant public health challenges. a study by crilly et al. [ ] pointed out that if the public were to use social media and mobile health apps for public health reasons, then topics such as weight management would be at the top of their list. by community pharmacy not embracing these telehealth and digital mediums they could be missing opportunities to support the public to meet a need that they have. this review has highlighted the positive role that telehealth and digital technology can play in supporting community pharmacists to deliver public health services. as such, these tools need to continue to be integrated within community pharmacy services. these tools will be particularly useful for those patients and customers who are not able to visit community pharmacies in person. given that the world is currently in the grips of a global pandemic, it is clear that offering community pharmacy users' methods of communication other than only face-to-face would allow the profession to continue to have an impact on public health regardless of the ability to physically meet [ , ] . the use of the telephone, in particular, has consistently shown to have a positive impact on participant health outcomes [ ] [ ] [ ] [ ] , , [ ] [ ] [ ] . the use of more novel telehealth and digital technology such as mobile health applications, social media, and video conferencing would benefit from further research. anecdotal evidence exists suggesting that community pharmacists do use these tools for public health purposes; however, future studies need to address how these compare to usual care and telephone only interactions [ , , ] . this study has demonstrated that if community pharmacy is to progress beyond the traditional face-to-face method of communication, then, more studies are needed that address the use of novel technology for a variety of public health topics. those who commission public health services should be consulted to determine whether a framework for delivering community pharmacy public health services is needed. a blueprint could be created that community pharmacists could use to develop new services. this blueprint would detail how to engage particular demographics, which types of technology are best suited for addressing particular health topics and whether combining technology with face-to-face interaction is needed. public awareness of the role of community pharmacy in public health also needs to be raised, as a recent study noted that the public would visit their gp or use an online resource to look for health advice rather than consulting a pharmacist [ ] . as such, community pharmacy needs to incorporate the methods of communication and the new types of technology that the public are using in order to be able to engage them in key public health issues. there were a number of limitations associated with this systematic review. firstly, this review was interested only in rcts. as a result, some other interesting studies that used alternative methods may have been missed. secondly, each of the studies identified had different primary outcomes, therefore, direct comparison of the results was not possible. finally, due to the everchanging nature of telehealth and digital technology, some novel tools used by community pharmacists for public health purposes may have been missed. this systematic review highlights how telehealth and digital technology is being used by community pharmacists to improve public health. we found that telephone calls and automated telephonic prompts were the most commonly used alternative method of communication to face-to-face discussions. there were limited studies on the use of more novel technology, with only one study using a mobile health app, one study using a remote health monitoring device, and no studies using social media. in addition, medication adherence was the main public health topic addressed in the studies, with other public health issues such as overweight and obesity, mental health, and sexual health not being investigated at all. studies that evaluate the use of more novel technology and a broader range of public health topics are needed to understand if community pharmacists can enhance their role in these domains and meet the needs of a digitally literate customer base. who. coronavirus disease . who website. . available online community pharmacist in public health emergencies: quick to action against the coronavirus -ncov outbreak providing pharmacy services during the coronavirus pandemic world health organization. noncommunicable diseases world health organization. global action plan for the prevention and control of noncommunicable diseases tobacco taxes as a tobacco control strategy evidence that a tax on sugar sweetened beverages reduces the obesity rate: a meta-analysis association between sugar intake, oral health, and the impact on overall health: raising public awareness. curr. oral health rep chlamydia screening interventions from community pharmacies: a systematic review benefits of pharmacist-led flu vaccination services in community pharmacy community pharmacists-leaders for antibiotic stewardship in respiratory tract infection health promotion and screening for cardiovascular risk factors in nsw: a community pharmacy model community pharmacist perceptions of their role and the use of social media and mobile health applications as tools in public health effectiveness of motivational interviewing interventions on medication adherence in adults with chronic diseases: a systematic review and meta-analysis the effectiveness of brief alcohol interventions delivered by community pharmacists: randomized controlled trial effectiveness of a community pharmacy weight management programme meta-analysis of the effectiveness of smoking cessation interventions in community pharmacy provision of contraception after emergency contraception from the pharmacy: evaluating the acceptability of pharmacy for providing sexual and reproductive health services community pharmacy type diabetes risk assessment: demographics and risk results effectiveness of community pharmacies in improving seasonal influenza uptake-an evaluation using the donabedian framework impact of community pharmacists' interventions on asthma self-management care pharmacy-led interventions to improve medication adherence among adults with diabetes: a systematic review and meta-analysis improving medication delivery and counseling in community pharmacy public views of different sources of health advice: pharmacists, social media and mobile health applications telehealth: misconceptions and experiences of healthcare professionals in england impact of ehealth on medication adherence among patients with asthma: a systematic review and meta-analysis the use of ehealth with immunizations: an overview of systematic reviews effectiveness of mobile health (mhealth) interventions for promoting healthy eating in adults: a systematic review a systematic review of reviews evaluating technology-enabled diabetes self-management education and support do e-health interventions improve physical activity in young people: a systematic review effect of a digital social media campaign on young adult smoking cessation the use of social media in pharmacy practice and education the role of social media in online weight management: systematic review a survey to establish greater london public perceptions of the use of digital technology and the role of the pharmacist when looking for health information using facebook and text messaging to deliver a weight loss program to college students results of the -month mobile pounds off digitally (mobile pod) randomized weight-loss intervention among adults national library of medicine current bibliographies in medicine health literacy and health information technology adoption: the potential for a new digital divide digital literacy knowledge and needs of pharmacy staff: a systematic review preferred reporting items for systematic reviews and meta-analyses: the prisma statement assessing the quality of reports of randomized clinical trials: is blinding necessary? rob : a revised tool for assessing risk of bias in randomised trials effect of automated immunization registry-based telephonic interventions on adult vaccination rates in community pharmacies: a randomized controlled trial impact of automated telephone messaging on zoster vaccination rates in community pharmacies pharmacist telemonitoring of antidepressant use: effects on pharmacist-patient collaboration map study: rct of a medication adherence program for patients with type diabetes long-term outcomes of the effects of home blood pressure telemonitoring and pharmacist management on blood pressure among adults with uncontrolled hypertension: follow-up of a cluster randomized clinical trial effect of home blood pressure telemonitoring and pharmacist management on blood pressure control a cluster randomized clinical trial two pharmacy interventions to improve refill persistence for chronic disease medications a randomized new medicine service": supporting adherence in people starting a new medication for a long-term condition: -week follow-up of a pragmatic randomised controlled trial internet-based photoaging within australian pharmacies to promote smoking cessation: randomized controlled trial effect of a mhealth intervention on adherence in adolescents with asthma: a randomized controlled trial patients' general satisfaction with telephone counseling by pharmacists and effects on satisfaction with information and beliefs about medicines: results from a cluster randomized trial effects of telephone counseling intervention by pharmacists (telcip) on medication adherence; results of a cluster randomized trial telephone follow-up of patients receiving antibiotic prescriptions from community pharmacies the cost effectiveness of a telephone-based pharmacy advisory service to improve adherence to newly prescribed medicines pharmacy, social media, and health: opportunity for impact community pharmacists, internet and social media: an empirical investigation practice innovations: delivering medication therapy management services via videoconference interviews the digital literacy skills of the community pharmacy workforce key: cord- -bhl up authors: rantsios, a.t. title: zoonoses date: - - journal: encyclopedia of food and health doi: . /b - - - - . - sha: doc_id: cord_uid: bhl up zoonoses are “those diseases and infections which are naturally transmitted between vertebrate animals and man.” relevant lists of zoonotic diseases are presented. factors, including environmental aspects that may influence the manifestation of zoonoses and their significance for public health, are discussed. foodborne, nonfoodborne, and vector-borne diseases are presented, followed by an article on preventative actions and control measures. specific reference is made to the ‘one health’ concept, since, for zoonoses containment, an integrated approach and cooperation between all responsible health professionals, at all levels, is a sine qua non precondition. according to the joint who/fao expert committee on zoonoses, second report, in the year , zoonoses (the expression zoonotic diseases is also used) are "those diseases and infections which are naturally transmitted between vertebrate animals and man." the transmission may take place directly or indirectly by means of vectors. the severity of zoonotic diseases in humans varies from mild symptoms to life-threatening conditions. zoonotic diseases are usually transmitted at the human-animal interface through exposure to animals (e.g., rabies), animal products (e.g., brucellosis and salmonellosis), or their contaminated environment (e.g., echinococcosis/ hydatidosis). transmission may occur by a diseased animal or by a clinically normal animal that, nevertheless, is able to transmit pathogens to humans (e.g., campylobacter and verotoxin producing escherichia coli (vtec)). a distinction is made between foodborne and nonfoodborne diseases. a concise list of zoonoses appears in table . emerging infectious diseases (eids) are diseases appearing in a geographic area or population for the first time. the term reemerging diseases is also used for ancient diseases that are 'forgotten' and thought to be controlled or extinct from a particular area or population and manifest a new appearance. the emergence of eids is thought to be driven by socioeconomic, environmental, and ecological factors. they are, mostly, related to free-living wild animals. the term neglected tropical diseases is used for a certain list of diseases recognized as such by the who, including a number of zoonotic diseases appearing in table . neglected tropical zoonotic diseases are ancient endemic zoonoses in europe and north america. they are largely controlled and tended to be overlooked, while the attention is shifted to newly emerged zoonoses. they can be, potentially, turned into a pandemic. although, at the time of the aforementioned who report, the number of zoonoses was at the level of , they are doubled by then and still counting. zoonoses may be bacterial, viral, parasitic, or due to unconventional agents (e.g., prions). it is estimated that out of the about human nosogenic factors, due to biological agents, % have multiple hosts and move between species. in addition, % of the eids, in the last $ - years, are zoonotic; again, % of which originate from wild animals. further to the significance of zoonoses for human health, one must not underestimate the impact they are having in preventing the efficiency in animal food production and enhancing problems in living animals and animal products international trade. as an indication of the significance of zoonotic diseases for human health, you can see, in table , the most important zoonoses in terms of human health impact, livestock impact, amenability to agricultural interventions, severity of diseases, and emergence. zoonoses present a major threat to human and animal health. these diseases, as already indicated, are multifactorial manifestations and therefore a reflection of the complexities of ecosystems in which animals and humans coexist. they are influenced by multiple interrelated global factors, including ecological evolution, human demographics, and behavior. emerging and reemerging diseases represent failures in understanding the socioecological systems we live in and respond to new conditions. what we learn from these failures will largely determine how successful we are in developing sustainable and healthy human communities. as can be seen in figure , humans, livestock, and wildlife can expose each other and spread, among them, potential pathogenic agents. any one of these players, therefore, can spill over pathogens to the others. more specifically, changes in human behavior, expressed as population increase and urbanization, and the demand for improved living conditions, requiring in turn proportional increase in food production and related economic activity, in particular agricultural development, are a decisive contributing factor. for example, water management, associated with still water collections, one way or another, increases mosquito breeding opportunities, which in turn may result in enhancing disease occurrence, like rift valley fever. such conditions are observed after the construction of dams and irrigation networks. similarly, intensive animal farming promotes disease transmission through untreated or poorly treated waste material spread in the environment or through ventilation system diffusion of contaminated material carrying pathogens. due to the problems related to high animal population density, maintained in intensive livestock production (e.g., pigs and poultry), which facilitated disease transmission, efforts were made to combat them with the use of antibiotics, either therapeutically or preventatively. however, these schemes resulted in widespread antibiotic-resistant pathogens, including those of zoonotic significance. these conditions, more specifically, can contaminate animal food products and potentially provide for the production of unsafe foods. it is important in this respect to mention that, according to eu food food production premises are considered as food business operations. consequently, they are obliged to certain responsibilities, related to putting together and effectively implementing and functioning a food safety management system (fsms), tailor-made for each particular activity. in table appears a list of zoonoses emergence linked to agricultural intensification and environmental changes. evidently, ecosystems are complicated, and the impact they are having on fauna and thereof on conditions potentially harboring zoonotic agents does not provide for a general interdisciplinary multipurpose approach, with patterns applicable in all cases. on the contrary, principal factors, among others, biological, ecological, economic, and social characteristics, and climatic conditions must be assessed, ad hoc, locally within each ecosystem. the implementation, therefore, of the concept of one medicine and one health, which, as an integrated approach, is very important for facing zoonotic diseases per se because not, only it contributes to animal and human health but also it significantly supports, apart from aspects of economic development, food safety and security. foodborne zoonotic pathogens are transmitted through consumption of contaminated food and drinking water. infectious agents present in foodstuffs include bacteria (e.g., salmonella and campylobacter), viruses (e.g., norovirus and hepatitis a virus), parasites (e.g., trichinella), and prions (infectious agents of bovine spongiform encephalopathy). challenges to food safety continue to increase in unpredictable ways, largely due to changes in food production, processing, distribution, and the environment, which may contaminate food; to emerging germs and toxins of food safety significance; and to new conditions, created by new food technology applications, with an impact on food safety (e.g., minimally processed foods and maintenance of cold chain). in table , a list of the most important biological hazards responsible for foodborne illnesses appears, along with the relevant most important foods involved in each case. nonfoodborne zoonotic diseases are transmitted through the following: • direct contact or close proximity with infected animals or through the environment. examples are the following: ○ avian influenza, a viral disease occurring mainly in poultry and other birds but transmissible to other animals or humans. ○ q fever, caused by the coxiella burnetii, affecting animals and humans. human infection mainly results from the inhalation of contaminated dust from the placenta and birth fluids or feces from infected animals. ○ salmonella infections, which can originate from contact with infected reptiles and amphibians such as pet snakes, iguanas, and frogs or their environment. ○ vtec, which can be acquired through contact with infected farm animals. for zoonoses prevention, the focus is on surveillance, rapid detection, and quick response. zoonotic infections in animals may produce a distinctive recognizable disease, such as rabies, or they may manifest themselves as a mild illness or the animal may be entirely asymptomatic. however, in this last case, if the pathogen is transmitted to humans, it may result in illness if they lack the specific immunity required. anyone, who has contact with animals, can get a zoonotic disease, but some people may be more at risk than others. risk table the most important zoonoses in terms of human health impact, livestock impact, amenability to agricultural interventions, severity of disease, and emergence data from the who and authoritative literature: when there are several authoritative estimates, the midpoint is given. note: high human mortality gets a double weight as the most important criterion for many stakeholders. total score ¼ (human death  ) þ (humans affected) þ (high livestock impacts) þ (farm intervention possible) þ (other concerns: severe or emerging disease). the maximum possible score is therefore and the minimum . factors for susceptibility to zoonoses, among others, are certain population groups, including professional and occupational groups working in close contact with animals (like livestock attendants, slaughterhouse workers, and veterinarians); homeless and poor people; and in general, people with a weakened immune system, children aged less than five, the elderly, and pregnant women. the factors promoting zoonotic disease outbreaks in humans, apart from frequent contact with animals, include intensive livestock production, poor animal and personal hygiene, and overlap with wildlife habitat. a common way for vector-borne diseases to spread is through the bite of a mosquito or tick. people can get diseases in most places, where they might have contact with infected animals and insects, including animal displays, farms, petting zoos, county or state fairs, pet stores, child care facilities or schools, nature parks, and wooded and bushy areas. in order to reduce the risks of transmission of zoonoses from pet animals to humans and also to production animals, the concept of responsible pet ownership (rpo) is advocated. it is recognized that education and awareness promotion of pet owners, for rpo, to prevent zoonoses related to companion animals, is of a paramount importance for eliminating these diseases. the who and efsa promote activities, of the general public's concern, for preventing zoonoses. they include the following: -promotion of awareness to understand the potential risk for human infection from zoonotic diseases, after contact with animals. -specific risk communication, as it may be required, through appropriate public actions. biosphere wildlife livestock humans peri-domestic wildlife figure pathogen flow at the wildlife-livestock-human interface. arrows indicate direct, indirect, or vector-borne candidate pathogen flow. in each host species, there are a vast array of constantly evolving microorganisms, some of which are pathogenic in the host. these are a source of new organisms for other host species, some of which may be pathogenic in the new host or may evolve in the new host to become pathogenic. if the pathogen is also transmissible in the new host species, then a new transmission cycle may be established. the rate and direction of candidate pathogen flow will depend on the nature and intensity of interaction between wildlife, livestock, and human compartments and the characteristics of the compartments ( table ) . adapted from proceedings of the national academy of science, may , , vol. , no , p. . -improvement in the level of personal hygiene by ○ acquiring the habit to wash hands thoroughly and frequently, after contact with animals. ○ closely supervising children to ensure they wash their hands properly and avoid hand-to-mouth activities (thumb sucking, eating, and use of pacifiers) after animal contact. -the use of registered insect repellents and products that contain repellents for use on clothing. accordingly, treat clothing and gear, such as boots, pants, socks, and tents. -inspection for and removal of ticks from the human body, with specific care for children. -limitation in the number of places around residential areas for mosquitoes to breed by eliminating places holding water. for health professionals, recommendations may include the following: -responsible services to systematically search for potential sources of human infection from animal sources and the environment -joint efforts and coordination among public health authorities and related professionals, both public and private -risk communication and information sharing among responsible health services and close coordination to manage risks related to the movement and trade of livestock -concerted actions for ○ good practices in the efficient implementation of biosecurity measures in farms and at border or territory crossings; ○ continuously reminding and training people, who work with livestock and in slaughterhouses, for the significant importance of personal hygiene practices; ○ the implementation of the one health concept zoonotic diseases are strongly influenced by social and economic practices. many of them are thus not only diseases related to climate and environment but also diseases of poverty. in epidemiological terms, conditions of poverty increase the probability of enhanced contact and hence increase the likelihood of epidemics. combating diseases like tuberculosis and malaria has much more to do with housing, nutrition, and water management than with any advances in biomedical science. animal migrations facilitate the global spread of pathogens and increase cross-species transmission. understanding, predicting, and controlling diseases at the human-animal interface are a huge challenge, for health professionals, in today's world, where international trade and travel globalized diseases. however, even when risks are identified, adequate underlying infrastructure and resources are required to take the measures needed, if outbreaks and emergencies are to be prevented or controlled. special consideration needs to be given to vector-borne diseases. vectors may move to long distances and therefore may introduce disease, in new geographic areas, by means of human traveling, international trade, animal movement (more specifically livestock and migratory birds), the wind, and changes in agricultural practices. health is a state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity. it is the outcome of a complex of several interdependent medical, economic, sociocultural, environmental, and ecological factors. people's health and well-being and equally animal health and welfare are strongly interlinked. both also influence and are impacted by the health of the environment. health is a precondition for well-being and respectively welfare. wellbeing and welfare reinforce health. the advancement of the health and well-being of people and animals depends on effective and sustained cooperation between varied professions and disciplines, in both the public and private sectors (world veterinary association (wva) position). therefore, multisectoral horizontal links at all levels between human and animal health professionals, public and private, are needed to face zoonotic diseases. reducing relevant risks is impossible to be achieved alone by a particular sector, regardless of its importance. therefore, there is an increasing convergence to a one health approach, which incorporates, in an integrated manner, cross-sectoral, multidisciplinary cooperation. one cannot distinguish human, animal, and environmental health. the health of each one of them is the precondition for the health of the others (see again figure ). building sustainable national mechanisms for more effective cross-sectoral cooperation has greatly facilitated risk assessment and management of specific diseases, such as h n influenza and rift valley fever. at the international level, strong cooperation among the who, oie, and fao is improving the efficiency of surveillance, including data collection, risk assessment, and risk management options, allowing for consistent, sciencebased risk communication on global health threats at the human-animal-ecosystem interface. a strategic agreement outlines the sharing of responsibilities and enhanced coordination of complementary roles and activities between the fao, oie, and who at national, regional, and global levels. internally, cooperation takes place across departments, clusters, and regions of the aforementioned organizations. externally, further cooperation materializes with links and contacts to additional international partners, such as international agencies and networks, ngos, and academia, and to national agencies, such as institutions and administrative governmental units. according to statements made by eu officials in support of it, one health is linked to livelihood and equity and fits with eu objectives to promote global security, social justice, international cooperation, and multilateralism and fight poverty. further, there should be no resignation vis-à-vis the existence of different health standards across nations. table biological hazards responsible for most important foodborne illnesses and related foods campylobacter (poultry) e. coli o :h (ground beef, leafy greens, and raw milk) listeria (deli meats, unpasteurized soft cheeses, and produce) salmonella (eggs, poultry, meat, and produce) vibrio (raw oysters) norovirus in many foods (e.g., sandwiches and salads) toxoplasma (meats) for the eu, the one health movement has in many senses grown out of the response to influenza-related crises. the definition of one health chosen by the european commission in its external relations and actions reads as follows: the one health approach consists of (i) improving health and wellbeing through the prevention of risks and the mitigation of the effects of crises that originate at the interface between humans, animals and their various environments; (ii) for that purpose: (a) promoting a multi (cross) sectoral and collaborative approach; and (b) promoting a 'whole of society' approach to health hazards, as a systemic change of perspective in the management of risk. in may , a meeting was organized by the centers for disease control and prevention (cdc), atlanta, georgia, the united states, titled 'operationalizing "one health": a policy perspective.' 'critical enabling initiatives' such as 'training,' 'one health global network,' 'information clearing house,' 'needs assessment,' 'capacity building,' 'proof of concept,' and 'business plan' were identified as fundamental to moving forward one health. further, it seems reasonable to think that an improved coordination that includes intersectoral cooperation in surveillance, communications, outbreak response, and sample sharing community-based interventions for the prevention and control of zoonotic diseases is needed. there is further and more specific need for systematic cooperation between strong and autonomous public health services and strong and autonomous veterinary services, in the respect of their specific expertise. however, a culture of cross-sectoral cooperation does not yet exist all along the chain. fostering such a culture, stretching from the field level to that of international organizations, is the big challenge for successfully controlling zoonotic diseases in general and more particularly either emerging or neglected ones. there is a deficit in current university medical training, due to the fact that the whole training concept is geared to treat, rather than prevent, diseases and preserve and promote health. a cultural change putting emphasis on the prevention and appreciation of the importance of the connection, in terms of health and well-being, between humans, animals, and ecosystems, is required. combating zoonotic diseases is not how to clean up the disease mess after the fact, but on how to prevent the mess from occurring in the first place. it would almost appear that the ideological lenses through which diseases in general are being studied preclude acting on the evidence. this, if nothing else, should raise a warning flag that those who study disease are not necessarily well equipped to promote health. see also: escherichia coli and other enterobacteriaceae: food poisoning and health effects; milk: processing of milk. the european union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in emerging infectious diseases of wildlife -threats to biodiversity and human health mapping of poverty and likely zoonotic hotspots joint who/fao committee on zoonoses, second report global trends in emerging infectious diseases zoonosis emergence linked to agricultural intensification and environmental change one health agriculture-associated diseases: adapting agriculture to improve human health public health impact of zoonoses and international approaches for their detection and containment oxford textbook of zoonoses. biology, clinical practice and public health control (oxford textbooks in public health) paho/who zoonoses and communicable diseases common to man and animals: vol. i. bacterioses and mycoses chlamydioses, rickettsioses and viroses brucellosis: recent developments towards ''one health coordinating surveillance policies in animal health and food safety: "from farm to fork sharing responsibilities and coordinating global activities to address health risks at the animal -human-ecosystems interface. a tripartite concept note foodborne disease outbreaks: guidelines for investigation and control steps in a foodborne outbreak investigation html -who initiative to estimate the global burden of foodborne diseases key: cord- -lvn hqk authors: rosenkötter, nicole; clemens, timo; sørensen, kristine; brand, helmut title: twentieth anniversary of the european union health mandate: taking stock of perceived achievements, failures and missed opportunities – a qualitative study date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: lvn hqk background: the european union (eu) health mandate was initially defined in the maastricht treaty in . the twentieth anniversary of the treaty offers a unique opportunity to take stock of eu health actions by giving an overview of influential public health related eu-level policy outputs and a summary of policy outputs or actions perceived as an achievement, a failure or a missed opportunity. methods: semi-structured expert interviews (n = ) were conducted focusing on eu-level actions that were relevant for health. respondents were asked to name eu policies or actions that they perceived as an achievement, a failure or a missed opportunity. a directed content analysis approach was used to identify expert perceptions on achievements, failures and missed opportunities in the interviews. additionally, a nominal group technique was applied to identify influential and public health relevant eu-level policy outputs. results: the ranking of influential policy outputs resulted in top positions of adjudications and legislations, agencies, european commission (ec) programmes and strategies, official networks, cooperative structures and exchange efforts, the work on health determinants and uptake of scientific knowledge. the assessment of eu health policies as being an achievement, a failure or a missed opportunity was often characterized by diverging respondent views. recurring topics that emerged were the directorate general for health and consumers (dg sanco), eu agencies, life style factors, internal market provisions as well as the eu directive on patients’ rights in cross-border healthcare. among these recurring topics, expert perceptions on the establishment of dg sanco, eu public health agencies, and successes in tobacco control were dominated by aspects of achievements. the implementation status of the health in all policy approach was perceived as a missed opportunity. conclusions: when comparing the emerging themes from the interviews conducted with the responsibilities defined in the eu health mandate, one can identify that these responsibilities were only partly fulfilled or acknowledged by the respondents. in general, the eu is a recognized public health player in europe which over the past two decades, has begun to develop competencies in supporting, coordinating and supplementing member state health actions. however, the assurance of health protection in other european policies seems to require further development. the maastricht treaty from marked the beginning of the health mandate of the european union (eu) as enshrined today in article of the lisbon treaty (tfeu, treaty on the functioning of the european union) [ ] . the original eu health mandate focused primarily on stimulating cooperation between member states and supporting national actions (art. ( ), treaty of the european union (teu)) [ ] . it embodied the union with only limited legislative powers on health matters. although this initial mandate was enhanced through subsequent treaties, today article , still gives the eu relatively circumscribed power in areas of public health (art. ( ), tfeu). healthcare continues to remain a national competence and in this regard, the eu "shall respect the responsibilities of the member states for the definition of their health policy and for the organization and delivery of their health services" (art. ( ), tfeu). despite the restricted treaty-based mandate for health, the eu has a relevant role to play in national public health and health systems policies and has expanded its remit in areas beyond the treaty [ ] . areas affected by eu provisions are extensively described in the literature [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . to illustrate the main developments in the area of what can be called "eu health policy" a timeline is illustrated in table . however, because of its limited legal mandate, some eu legal initiatives were highly contested [ , ] . therefore, one can pose the question of what has been achieved over the last twenty years. it may be argued that, despite its narrow legislative scope, the health mandate has triggered important european actions in certain public health areas like tobacco control [ , ] , infectious disease control [ , ] , european guidelines [ ] [ ] [ ] and the development of an eu public health infrastructure [ ] . in recent years, the ec has summarized in annual reports a diverse nature of key public health achievements such as communications and recommendations, health policies, ec co-financed actions and established networks (e.g. high level groups, scientific committees, platforms) [ ] [ ] [ ] . however, stakeholders in the field provide examples indicating that public health relevant eu policies such as single eu policy assessments on the common agriculture policy (cap) [ , ] , pharmaceuticals [ ] , or the health in all policy (hiap) approach [ ] do not always meet the expectations of the public health community. in these papers the authors express concerns about potentially detrimental health effects [ , ] or disappointment about the support of the policies and approaches aimed at improving health in europe [ , ] . also, eu agencies such as the european centre for disease prevention and control (ecdc) are described as agencies with a limited legal mandate, competences and resources for eu public health but, at the same time, with promising prospects to develop as a renowned international player in the field [ ] . in addition, an evaluation of the eu health strategy acknowledges its status as a guiding framework for ec health policies and joint ec and member state actions table timeline of main developments in eu health policy year eu health policy developments before the introduction of a legal eu health mandate treaty of rome: health is not a priority. two aspects are considered: social security of cross-border workers and occupational health. on health but also identifies the missing impact of the strategy on other ec policies as well as on member state health policies and actions [ ] . evaluations of the eu public health programmes, which are one of the ec's financial instruments to implement its strategic health goals, criticize missing prioritization of topics, barriers for participation in projects for some member states and ineffective dissemination of project results [ , ] . hence, the available evidence of the impact of eu health policies, infrastructure, and actions is elusive, and the identification of the value of public health relevant eu-level actions across all policies is lacking. in this paper, we aim to explore and provide an overview of influential public health relevant eu-level policy outputs and a summary of policy outputs or actions perceived as an achievement, a failure or a missed opportunity by interviewing key experts in the field. by this, we intend to establish a qualitative indication of which eu health policies have contributed to the improvement of population health in europe. the study focused on the evolvement of the health mandate since , the year the maastricht treaty was signed. the study was carried out in two consecutive phases: ( ) qualitative interviews, suitable to identify expert perceptions, and ( ) voting on influential and public health relevant eu policy outputs and actions based on nominal group technique. the study adhered to the rats guidelines on qualitative research [ ] . experts were purposely selected to ensure heterogeneity of opinions. the selection was based on their individual profile and professional affiliation. we selected experts that were renowned in the field due to their current or former affiliation to specific eu-level bodies and institutions, research institutes with eu focus, or eu-level nongovernmental organization. selected experts were actively involved in public health research, policy-making, policy advice or advocacy performed at eu level, internally or externally. in addition, snowball sampling was applied until data saturation was reached. data saturation was assumed as soon as no new eu public health policy actions and their perceptions were mentioned during the interviews. the potential participants were contacted between december and march by a short information email to identify whether they were interested to participate in the interview study. of contacted experts, twenty participated in this study, one participant could not confirm participation due to time constraints and another did not respond to the invitation. of those twenty experts nine belonged to the initial purposively selected sample and eleven were identified during the snowball sampling procedure based on recommendations of already interviewed experts. the majority of experts was affiliated to an institution located in brussels (n = ). the composition of the study sample in terms of represented professional affiliations is outlined in table . upon agreement by the participant, an appointment for the interview was made and participants received an informative letter with more in-depth information about the goal of the study and an informed consent form in which the voluntary basis of the participation has been clarified and anonymized data handling was assured. interviews were conducted either face-to-face (n = ) or via telephone, or voice over ip (n = ) in the period between january and march and were held in english, dutch or german by one of the three principal investigators (nr, tc, ks). the interviews lasted from to minutes. all interviews were audio-recorded, transcribed verbatim and anonymized. the interviews were performed using a specifically designed semi-structured interview guide. the guide was developed on the basis of previous desktop research and an internal brainstorming session of an advisory research group consisting of the three principal investigators, four senior researchers, and one junior researcher of the department of international health at maastricht university to identify items relevant for investigating expert perceptions on european public health policy. during the course of this process, a list of public health relevant eu policy outputs, processes or procedures that were regarded as achievements, failures or missed opportunities were first gathered individually and then, following a group discussion, a common list was compiled. this output was used to construct the interview guide containing six guiding themes from which open-ended questions were formulated. the guiding themes included ( ) a description of the individual role of the expert in european public health, ( ) the individual definition of european public health, ( ) the assessment of public health relevant eu-level actions as being an achievement, missed opportunity or failure, ( ) the formulation of five influential european policy outputs, ( ) consequences of european health policy, and ( ) the policy process at the european level. the semi-structured interview guide was used as a framework for the interviews and allowed the interviewers to address other relevant topics that emerged during the interviews. after completion of interviews the three principal investigators initially performed an internal analysis of each separate interview and an analysis across interviews to identify the scope of eu-level actions and experts' perceptions of these actions as achievements, failures or missed opportunities [ ] . afterwards, a directed (or deductive) content analysis approach [ , ] was applied whereby the initially predefined coding scheme with the main categories of interest (achievement, failure, and missed opportunity) was used to summarize the respective topics and the reasoning that appeared during the interviews. topics that did not fit into one of these main categories were added as new codes and were organized into new categories. the analysis was jointly performed by the principal investigators using nvivo (qsr international pty ltd. version ). furthermore, the results of the content analysis on achievements, failures and missed opportunities were grouped according to the major common themes in a table to provide an overview of the perceptions of the key informants. prominent eu-level outputs or actions, which were discussed by almost all respondents, are described in more detail in the results section. where applicable, we used original quotes to illustrate the views and tendencies of experts' assessments. the professional profile and study id of respondents are indicated behind the respective quotes. quotes which were originally given in dutch or german were translated into english. a slightly adapted nominal group technique [ ] was used for triangulation purposes. during the interviews, the participants were asked for five influential policy outputs of european health policy-making. following the finalization of all interviews, all participant nominations were compiled in one list and reoccurring topics were removed. to ensure comparability of policy outputs and actions, we grouped the nominations into categories under the following headlines: (a) secondary legislation and court decisions; (b) soft laws, strategies, and programmes; (c) agencies, centres, organizations; (d) networks, policy platforms, cooperation; and (e) others. participants were asked in an online survey to select three outputs per category which were, according to their opinion, most influential. based on the participants' nominations, a ranking in terms of a frequency distribution of selected influential policy outputs for each category was determined. the online survey was completed by out of participants who took part in the interviews. the design and analysis of the study was guided by applying guba and lincoln's test for trustworthiness [ ] . credibility and dependability have been ensured by enlarging the sample until saturation was reached in terms of the identification of eu policy actions and their perceptions. moreover, three researchers in the primary research group in combination with an internal advisory research group were involved with the aim of reflecting upon the study design and critically questioning the findings. additionally, the primary research group met regularly during the interview period to exchange initial findings and experiences on the interview process. the members of the internal advisory research group were experienced in eu public health policy research or qualitative research methodologies. the confirmability was strengthened by the use of several investigators both in the data collection process and in the analysis phase, combined with the use of triangulation, where interview participants were also asked to participate in the ranking exercise. the medical ethical committee of the university hospital maastricht and university maastricht declared that no ethical approval was required for this type of research. all participants were informed about their role and rights as study participant prior to their interview participation. all participants provided written or audio-recorded informed consent to be interviewed. overall, respondents consistently mentioned that, during the twenty-year history of the eu health mandate, specific initiators induced change in european public health policy. the most important identified initiators included the maastricht treaty with its later amendments, the health-related rulings of the european court of justice, and the health crises such as boviene spongiforme encefalopathie (bse) and severe acute respiratory syndrome (sars). in addition, the internal market provisions with the foreseen free movement of goods, people, services and capital, initiated change with both negative and positive public health impact. additionally, a set of conditions was identified in the interviews that described and advanced the role of eu health policy as a reference point for public health. these conditions under which eu health policy made progress during the past twenty years were (i) the regulatory power at the eu-level, (ii) eu-led facilitation of cooperation and comparisons across member states; along with (iii) increased capacity building on eu issues and on eu-level (e.g. professionalization, development of interest groups, associations). the ranking of influential policy outputs of eu-level health policy-making is provided in table . in the category "secondary legislation and court decisions", the patients' rights decisions made by the european court of justice (n = ) were chosen by most of the respondents as influential policy output, followed by the directive on the application of patients' rights in cross-border healthcare [ ] (n = ) and the directive on advertising and sponsorship of tobacco products [ ] (n = ). in the category entitled "soft laws, strategies, and programmes", the first and second eu public health programmes [ , ] (n = ) were selected most frequently, followed by the - health strategy "together for health" [ ] (n = ). the third rank is shared by three policy outputs: the "framework for action in the field of public health" [ ] (n = ) which is the commission's first proposal setting out eu-level public health after the introduction of the health mandate in the maastricht treaty, the council conclusions "towards modern, responsive and sustainable health systems" [ ] (n = ), and the current over-arching european strategy "europe " [ ] (n = ). in the third category on "agencies, centres and organizations", the european medicines agency (ema, n = ) ranked top, followed by the ecdc (n = ) and the european food safety authority (efsa, n = ). among "networks, policy platforms and collaborations", the european presidencies (n = ) were selected most often by the respondents, followed by the collaboration of the european commission (ec), the world health organization regional office for europe (who-eur) and the organization for economic co-operation and development (oecd) (n = ). moreover, the three entries on the third rank include the eu health policy forum (n = ), the network on epidemiological surveillance and control of infectious diseases (n = ), and the network on health technology assessment (n = ). the fifth category was not topic specific therefore, work on european level health determinants (n = ), the exchange of best practices (n = ), and published scientific reports which influenced eu policy-making (n = ) were ranked on the first three positions. at a glance, the label "achievement" was allocated to the public health mandate as it is laid down in the treaties, the establishment of eu-level agencies dealing with public health topics and successes in smoking prohibition, food safety and infectious disease control. the label "missed opportunity" was allocated to the insufficient degree to which the hiap approach is implemented and the ways in which health promotional aspects of alcohol and nutrition were handled. the label "failure" was less often assigned with the missing integration or link to social policies appearing in some interviews under this heading as well as the strength of the internal market which annulled national protective alcohol legislations in some member states. in table , we provide the full list of eu-level outputs or actions which, based on the content analysis and the identified thematic categories, were mentioned as achievements, missed opportunities or failures by the key informants. due to a broad and divergent spectrum of perceptions, topics almost always shared aspects of achievements, missed opportunities or failures. in the following section, we focus on those eu-level outputs or actions which were mentioned by the majority of respondents during the interviews and allowed us to draw a comprehensive picture on the breadth and the diversity of expert perceptions. an assessment of the general value of eu-level public health actions over the last twenty years resulted in mainly ambivalent judgments. on the one hand, many relevant activities were performed at an eu-level and the existence of a health mandate contributed to an eu social model. on the other hand, its dependence on political will and economic circumstances influenced the development of eu-level public health policy and led to the perception that more should or could have been achieved within and beyond the possibilities of the current health mandate. the establishment of the directorate general for health and consumers (dg sanco) in as an independent, formal structure for eu health policy was generally discussed as an achievement. the formation of dg sanco, and thus, the political decision to separate the health dossier from dg v, the former dg with the responsibility for health policy as well as a focus on employment and social policies, was controversially perceived. the establishment of dg sanco led, on the one hand, to a more mature health policy field. "…the dg v was a big dg and then dg sanco became separate from that. health had its own commissioner, its own opportunity to protect itself and public health benefits." (# , public health advisor/advocate) on the other hand, aspects of failure were mentioned regarding the detachment of health and social policy at eu-level. according to the respondents being separated led to a loss of collaboration for more holistic health policies and actions in health systems and healthcare at eu-level. a following the formation of dg sanco, it was seen as a beneficial way forward for the dg to shift its sectorial policy approach from a focus on specific topics such as cancer, drug dependence, health monitoring, accidents and injuries, or pollution-related diseases, to a horizontal one with the formulation of the first health strategy with three cross-cutting objectives: health information, health threats and health determinants [ ] . "and this was an important moment in time where the sectorial approach to aids, cancer and other issues has been reduced gradually and that more the integral horizontal approach, which was applied at that time already in all member stateshence europe was running behind in that sense, but ultimately was embraced and taken as guideline for the framing of all sorts of public health actions. "(# , eu/national civil servant) since it fostered more visibility of the public health field and closer cooperation by financing projects, joint actions and research across europe, the public health programme of dg sanco was commonly discussed as being supportive to the development of european public health and the mobilization of the public health community. aspects of missed opportunity became relevant when assessing the representation of health in other eu policies. "i don't know what exactly the reason is, but they [dg sanco] are not strong enough to push for health in [the other] dgs. the obvious example is the latest eu strategy, you cannot find reference to health anywhere it's really a disaster, because of [the] weak dg sanco. health is not among the headline targets, it's not among the flagships." (# , public health advisor/advocate) while the cooperation with other dgs was recurrently discussed as problematic, the potential for the "partnership on active and healthy ageing" under the european innovation union appeared as a unique theme and was regarded as an achievement for strengthening health policy on the general eu policy agenda. ecdc profile should cover also non-communicable diseases and sdoh. coordination of the approval of efficacy, safety and quality of drugs. cost-effectiveness of pharmaceuticals is not taken into account. problem of not being able to tackle pharmaceutical pricing. reversal of the approval of already approved drugs not handled on eu-level. control of health claims of food products. efsa mandate should include/be stronger on health promotion aspects of nutrition (e.g. regulation of advertisement of unhealthy food products). food safety directive. health mandate assures that health protection should be guaranteed in all eu policies. hiap and health impact assessment have never been implemented fully (tick box exercise). leads to the discussion of health in other sectors. control; tobacco product-; tobacco advertising directive). the tobacco regulations could have been designed stronger (e.g. more harmonized realisation of smoking prohibition on public places). tobacco regulation has some aspects of failure since a strict, general ban is not reached. food safety measures and regulations on health claims. missing political will to tackle obesity and related life style factors like unhealthy food products. health research programme eu health research budget and outcomes of the programme. missing integration of the research programme and eu health research outcomes in public health. health research budget. the use of structural funds for investments in health ( ) ( ) ( ) ( ) ( ) ( ) ( ) . internal market rules as source for legislation should be more attentive to health concerns. internal market provisions cause problems if member state regulation is more protective regarding health threats than eu regulation. the patients' rights directive in general. negotiations on patients' rights directive failed to include a strong emphasis on the development of common standards. effect on cross-border cooperation. gives legal certainty to policy makers. policy field which starts to recognize health, e.g. in its white paper on the cap after ( / (ini)). unrecognized potential for health of the cap by public health sector. health life years as indicator in the lisbon strategy. missing health information system. lack of morbidity data. different public health topics health inequalities ec communication: solidarity in health: reducing health inequalities in the eu. strengthening of the hta approach in the eu. coordinating cross-country level health technology assessments. coordinated management of rare diseases. existing drug resistance of tuberculosis as indicator for lacking disease management. health of minorities (e.g. roma) as part of the european agenda. social care is hardly seen as eu competence. environmental standards set by the eu. missing follow-up process on the environment and health action plan ( ) ( ) ( ) ( ) ( ) ( ) ( ) . blocking of direct to consumer advertising of prescription-only pharmaceuticals. white paper on governance ( ) increased transparency. more standardisation of methods (evaluation of indicators, outcomes, policies) and common language. increased understanding of the public health community about the impact of eu policies on public health. cooperation with industry influences the health research agenda and policy-making. evidence-based policy-making: the interest of the industry is against public health. and that's a good sign, if we can get more of those sorts of partnerships on specific policies, then i think, we'll get a better understanding."(# , eu/national politician) with regard to assessing the status of dg sanco cooperation with other international policy actors, respondents had mixed perceptions. whereas some argued that dg sanco's collaboration with international organizations like the who-eur or the oecd is improving and therefore, can be considered as an achievement, others asserted that this collaboration was not sufficiently established and can therefore be categorized as a missed opportunity. the establishment and the work of eu public health agencies like the ema, the ecdc, the efsa, and the european monitoring centre for drugs and drug addiction (emcdda) were regarded as an achievement and as an important step forward towards the strengthening of the european dimension in health. the work and the scope of the agency mandates was a recurring topic and subject to diverging perceptions. as an example, in the case of the ecdc, its development was assessed as an achievement whilst its scope was considered a missed opportunity. the bioterrorism attacks on the united states of america in and the sars crisis led to calls for better international coordination of infectious disease surveillance and the establishment of ecdc in [ ] . hence, the setting up of ecdc was commonly perceived as an achievement, since it gave preceding eu actions in infectious disease control a formal structure and maintained actions in the field. also, the close collaboration with the respective national public health agencies during outbreaks and in negotiating and developing common guidelines for infectious disease control were regarded as an important task of the ecdc. however, a number of respondents were critical of the scope of the ecdc mandate and thus, looked at this as a missed opportunity. questions were raised on whether the ecdc's responsibility in surveillance, risk assessment and training are sufficient or if additional responsibilities in risk communication and management were needed to assure full stewardship during and in the prevention of health crises. "i suppose the flu epidemic […] . that should be put on the table not only as a missed opportunity, big failure, having put ecdc at the center of the development, but the ecdc is not authorized to risk communicational management as you know. so, in that sense, it is a failure that member states were not able to coordinate in this very important public health area and use the eu institution, either ecdc or who to do that." (# , public health advisor/advocate) moreover, interview participants reported tensions between member states and eu agencies regarding the transfer of responsibilities from national to eu-level. "and the member states are very reluctant to hand over power regarding public health to the commission, or to brussels. now if you focus on infectious diseases, that is much better because they understand that there is a need, but again it is not easy." (# , eu/national civil servant) since the largest burden of disease in the eu is caused by non-infectious rather than infectious diseases, a call was put forward to further increase the mandate of ecdc to all public health relevant aspects and not focus only on infectious diseases. the hiap approach was generally assessed as an achievement regarding its potential to address health determinants outside the health sector. "[the article on the health mandate] is very important, because thereby a mandate is created that the commissioner for health and consumer affairs […] approaches his colleagues whenever they make new legislation to ensure that the health protection dimension is guaranteed; it gives partly a mandate to break into the policy and law development in sectors which in principle do not have any links with public health. […] this is very difficult. but its potential is very strong." (# , eu/national civil servant) however, in regard to its degree of implementation participants commonly perceived hiap as a missed opportunity. health impact assessment, the implementing tool to hiap, was regarded as a "tick box exercise" (# , # , both public health advisor/advocate) rather than a thorough consideration of health in other policies areas. explanations given during the interviews demonstrated that conditions to achieve hiap seemed not to be established yet and that there seems to be difficulty in bringing dg sanco interests in line with the interests of other dgs without over-emphasizing the health aspect. political assertiveness in convincing other commissioners and dgs about the relevance for intersectoral cooperation was perceived to be lacking, even though an inter-service group on public health with the participation of more than twenty ec departments was established for this purpose. generally, the work regarding tobacco was regarded as an achievement of how european health policy-making effectively addressed a life style risk factor for health. "the progress around tobacco [directive on tobacco advertising, directive on tobacco products, transparency register], the fact that we have a piece of international law on tobacco [who framework convention on tobacco control] is massive and that was european led." (# , public health advisor/advocate). this quote echoed the perception of the majority of respondents who emphasized the leading role of the eu regarding the support and commitment to the who framework convention on tobacco control. moreover, it was argued that the achievements regarding the regulation of tobacco advertising and smoking prohibition in public places would not have been achieved by single member states independently and thus this was a common achievement initiated and supported by european cooperation. nevertheless, aspects of a missed opportunity or even failure were mentioned in this regard since some would have appreciated stronger legislative measures to achieve a more harmonized realization of smoke-free legislation across the eu. it was considered that the achievements recognized in eu tobacco legislation were missed in the regulation of other health-related life style factors such as nutrition and alcohol. whilst regulations in the area of food safety were generally acknowledged as an achievement by preventing food-borne health threats; a potential mandate to address the composition of food and thereby, prevent, inter alia obesity or non-communicable diseases seemed to be neglected and was labeled as a missed opportunity. "…food safety has been majorly put forward over the last twenty years, in the sense that we know that the food will not be contaminated. but then it is a missed opportunity in the sense that beyond food safety there is health promotion and then one wanted the union to have more powers to regulate issues on the content of saturated fat for instance or the percentages of sugar and so on." (# , public health advisor/advocate) with regard to governmental activity on these issues, the eu platform for action on diet, physical activity and health was named as an example of an achievement as well as a failure. "i think the diet platform […] can be seen as a failure and opportunity. […] if we had not created that platform then arguably the issue wouldn't have been tackled at all. and in a way that has been really brought some issues of complexity to the political discussion around issues around marketing of food, around self-regulation, reformulation, some of the initiative like salt in diet has come as a commitment from that platform."(# , public health advisor/ advocate) the failure aspect of the eu platform for action on diet, physical activity and health was related to the perception that a platform is a rather weak policy instrument and that more political will to tackle these issues with stronger eu policy or legal instruments would have had more impact. additionally, the lack of timely cooperation of public health professionals with other sectors such as agriculture was raised as missed opportunity. it was illustrated that agriculture policy has public health relevant links regarding affordability, accessibility, and the availability of food. however, it was also argued that this cooperation has been developed further over the recent years. "and it is correct, that the common agriculture policy has not been taken up health in the beginning, but by now they are doing this very consciously. […] thus, i really see an improvement; i actually do not see a situation anymore in which health was influenced really negatively [by the common agriculture policy]." (# , eu/national civil servant) internal market provisions were perceived as ambivalent by the respondents. the eu is based on internal market rules that also affect eu health policy. "the engine of european health policies is still the market."(# , academia) however, the influence of eu market regulations, for example on alcohol policies, was perceived as a failure when member states had more protective and stricter national legislation as was the case in the nordic countries. respondents claimed that eu internal market regulations that are more attentive to health issues would be appreciated in this case. moreover, the potential given by articles and of the tfeu, which put limitations on the single market, was mentioned and it was perceived as a missed opportunity that this potential had not been fully taken up by public health experts: "[…] the public health aspect, which is written into article [now article , tfeu] on the internal market, you can put limits on the internal market on the grounds of public safety, public morality and public health, is almost never used. what if dg internal market was turned into our greatest weapon?" (# , public health advisor/advocate) this was positively exemplified by the case of tobacco control which applied internal market rules for public health purposes to assure harmonized labeling, packaging, nicotine content, etc. across the eu. however, the application of the health argument to put limitations on the internal market rules was also perceived as being negatively connoted by non-public health experts: "if you just go to the dg internal market and grab the first person you see and ask them what public health means, they will tell you it's the exception member states use to defend local weird monopolies on peculiar alcohol, or something like that. it's an exception to a rule." (# , academia) the recent eu patients' rights directive in cross-border healthcare [ ] was mainly regarded as an important achievement. this assessment was not necessarily driven by satisfaction with the scope of the directive but, instead, because it is the first eu secondary legislation ever enacted specifically on healthcare. "[…] the cross-border directive will turn out to be incredibly important. particularly because it is so symbolic important if you like because it does represent really the first time that the eu has got any concrete in relation to healthcare as opposed to public health. the consequences of this remains to be seen." (# , eu/national civil servant) "therefore, i see the patients' directive as a true success from a legislative perspective" (# , academia) the achievement aspect was supported by perceptions that the directive will lead to more cross-border cooperation and will have an impact on quality of care as well as on priority setting in healthcare and the packaging of healthcare services. thereby, it was expected that the directive will not only influence people who seek healthcare services in other countries but also those who seek services in their home country. in this regard, some expected that the directive would also ultimately empower patients as consumers of healthcare services. "the cross-border directive […] will have consequences of more consumer empowerment, consumer rights, patient rights, more consumer participation and more literacy,…"(# , public health advisor/advocate) however, there were also critical voices that interpreted the directive, as targeting a limited segment of the european population and hence, potentially increasing health inequalities. these respondents also questioned the willingness of the general population to seek healthcare treatment outside their home country. furthermore, respondents were critical of the extent to which more eu involvement in healthcare of member states would lead to quality assurance in general: "it is positive in the way people can be treated where they want, but it is still my point of view that we […] want to have our own level of quality and we don't want others to decide what level it should be. perhaps, because we have a very high quality […] . but of course we don't mind to tell others about it, we don't mind others to come in, we don't mind to help others to get the same standard -that is cooperation, so i always say i love cooperation but i do mind the harmonization.". (# , eu/national politician) this study provides an overview of public health relevant eu-level actions of the past twenty years. we outlined the diverse nature of expert perceptions on key developments in the field and provided a ranking of the most influential achievements. the assessment of outputs or actions being an achievement appeared across and within interviews along with assessments of outputs or actions being a missed opportunity and less often a failure. thereby, it turned out that the eu public health field has significantly developed its organizational structures (dg sanco, supranational agencies dealing with public health) and incorporated public health topics like infectious disease control and tobacco control, whereas the hiap approach still included untapped potential. this finding confirms "the challenge of implementation" [ ] of the hiap concept in the eu [ , ] . given the fact that according to article and article ( ),tfeu [ ], a high level of human health protection should be ensured within all eu policies and actions, it was seen as a weakness that the uptake of health consideration in the general eu policy-making process was low [ ] . ollila described the importance of communication and cooperation strategies for a successful realization of the hiap approach [ ] . the deficiency of these strategies was raised during the interviews which indicated that the performance of eu health players is perceived to be particularly poor in this regard. concordance of interview responses with tasks formulated in the health mandate of the eu interestingly, the study indicated that the treaty-based tasks such as support of cooperation between member states, development of guidelines and indicators, best practice exchange, and periodic monitoring and evaluation on eu-level public health to ensure 'a high level of human health protection' [ ] were only partially perceived as fulfilled or acknowledged by the interviewed experts. thematic discussions on actions or policies related to the development of guidelines and indicators appeared with regard to infectious disease surveillance and management of rare diseases but were not a major theme across interviews. the eu-level task to promote best practice exchange among member states was regarded as influential, which is represented by a top position in one of the rankings presented in this paper. with regard to the task of establishing monitoring and evaluation structures, some respondents perceived the status of the eu health information system rather as a failure. this corresponds to observations in the literature indicating that although ground work such as the development of a common eu health indicator set is acknowledged [ , ] further efforts are needed to implement and maintain health indicators [ ] and to develop a permanent and sustainable eu public health monitoring and reporting infrastructure that supports decision making in public health on eu level [ , ] . respondents agreed that cooperation in the area of public health between member state representatives and experts as well as with other stakeholder groups has increased and has been facilitated by the eu through various projects, networks, forums, and platforms. this trend was mainly positively perceived since it supported eu-level public health policy by accumulating and exchanging knowledge, generating public support and a legitimacy to act on certain fields [ ] . this finding is corroborated by the literature on the potential of new governance instruments for health-and social policy-making at eu-level [ , [ ] [ ] [ ] . however, these new governance instruments can also be regarded as a rather strategic investment of the ec to keep topics on the agenda until a political window of opportunity opens but as an ineffective policy tool to enforce and implement action in due course [ ] . the collaboration of a diverse set of stakeholders as it is the case for example in the eu platform for action on diet, physical activity and health can lead to actions that constitute rather a compromise of various interests. consequently, the results might be disappointing from the viewpoint of public health experts [ , ] . a final judgment on the impact of facilitating collaboration is to be awaited and may only be made in the long term future. it will require different ways of measuring 'impact' compared to the analysis of domestic adaptations when implementing eu hard law [ ] . the assessments of ec tasks for public health policy making have been influenced by characteristics like the subsidiarity principle throughout several interviews. on the one hand some participants were in favor of more eu influence on health policies and their implementation. in their view integration and harmonization of health policy did not reach far enough and hence their perception of actions was dominated by the category 'missed opportunity'. on the other hand some experts were in favor of keeping certain health issues like health care as national responsibility which led to a perception of too much eu involvement and a negative perception of the evolvement of the health mandate. public health has a cross-cutting nature and cooperation across dg's often poses difficulties. therefore, convincing evidence is required to demonstrate the health impact of policies outside the health domain and strong partnerships are needed to counter strong industrial lobbying groups [ , , ] . the ease of cooperation and the potential to achieve policy coherence between dg sanco and dgs with stronger regulatory competences like the internal market (e.g. regarding tobacco, pharmaceuticals) or agriculture policy (regarding food safety, subsidies of unhealthy versus healthy food products) represented another characteristic that influenced the individual perception of eu public health policies. experts who assessed the value of eu health policy actions under the reality of a rather weak health mandate were more likely to perceive eu actions as achievements. this was in contrast to others who strove for more appreciation of social and health matters in eu policies and who perceived a lot of missed opportunities or failures in this regard as the power of the eu was too weak to realize change and to fulfill the objective of the health mandate to ensure human health protection for citizens in the eu. in summary, underlying themes such as cooperation among european public health professionals, increasing institutionalization, and characteristics such as the issue of subsidiarity or the possibilities to cooperate across eu policy domains influenced experts' perceptions throughout the topics presented in this paper. these conditions and characteristics are part of what lamping called the "chaordic dynamics" of european integration in the field of health policies [ ] . as our study demonstrated eu health policy does not demonstrate a clear-cut success since the logic of action in the field can involve diverging interests. nevertheless, the eu public health has quite systematically developed in terms of scope and impact beyond the original mandate. the ranking of influential policy outputs provided indications on important developments in eu public health policy. however, even though we categorized the outputs, they sometimes differed in character and power which might have led to imbalanced judgments. additionally, we received different reasons for labeling eu-level actions or policies as achievements, missed opportunities or failure for public health. some were identified because they increased the strength or value of eu-level public health policy, whereas, others were identified because they impacted the health of the european population. the findings of the study may not be empirically generalizable since they were closely linked to qualitative individual perceptions and the settings that participants belonged to. however, we are confident that the broad range of profiles of the experts has ensured the diversity of perceptions on the topics varying from achievement to missed opportunity and failure. moreover, given that participants were generally active in health policy at eulevel and mainly positive about the eu, this could also have influenced the obtained results to some extent. eu public health policy is subject to divergent perceptions of how successful or unsuccessful specific topics have been tackled and how far european integration in public health policy should go. from the findings, it is unequivocal that the eu has strengthened its role over the past twenty years in supporting, coordinating, and supplementing member states' actions on public health issues as laid down in article ( ), tfeu. the eu is now a recognized player in public health in europe. however, when it comes "to the promotion of a high level of […] protection of human health […]in defining and implementing its policies and activities" (article , tfeu), further work is needed to achieve the full potential of the eu health mandate. endnote a also several eu member states disconnected on national level the ministry of health from social affairs. at the time of writing only seven out of eu member states organized health and social affairs within one ministry (spain, france, sweden, finland, estonia, greece, the netherlands). regulation (eec) / on the application of social security schemes to employed persons and their families moving within the community (accompanied by implementing ec launches the action programme maastricht treaty: the legal basis for undertaking actions in the field of public health is defined in article year eu health policy developments after the introduction of a legal eu health mandate by the maastricht treaty the european agency for the evaluation of medicinal products (emea), now european medicines agency (ema), has been formed in london. treaty of amsterdam: health impact assessment is implemented directorate general for health and consumers (dg sanco) is established lisbon agenda recognizes health protection as a prerequisite for economic growth measured with the indicator healthy life years the european food safety authority (efsa) has been established in parma first programme of community action in the field of public health the tobacco advertising directive / /ec is adopted after the first version has been annulled by the european court of justice commission decision to set up an executive agency for the public health programme. it has the task to manage community action in the field of public health the european centre for disease prevention and control (ecdc) in stockholm is operational white paper: together for health: a strategic approach for the eu decision for a second programme of community action in the field of health directive / /eu on the application of patients' rights in cross-border healthcare has been adopted. abbreviations aspher: association of schools for public health in the european region boviene spongiforme encefalopathie; dg: directorate general; dg connect: directorate general for communications networks, content and technology; dg sanco: directorate general for health and consumers emcdda: european monitoring centre for drugs and drug addiction; eu: european union; gats: general agreement on trade in services; heidi: health in europe: information and data interface; hia: health impact assessment; hiap: health in all policies; hta: health technology assessment; oecd: organization for economic cooperation and development; sars: severe acute respiratory syndrome; sdoh: social determinants of health; tfeu: treaty on the functioning of the european union; who-eur: world health organization-regional office for european union: the maastricht treaty. the treaty on the european union (teu). maastricht: european union european union and health policy: the "chaordic" dynamics of integration the impact of the eu law on health care systems eu law and the social character of 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parliament and council of the european union: decision setting up a network for the epidemiological surveillance and control of communicable diseases in the community ( / /ec) european commission: commission decision / /ec on the early warning and response system for the prevention and control of communicable diseases under decision no / /ec european guidelines for quality assurance in colorectal cancer screening and diagnosis european guidelines for quality assurance in cervical cancer screening european guidelines for quality assurance in breast cancer screening and diagnosis eu regulatory agencies and health protection. in health systems governance in europe public health and risk assessment directorate: key achievements public health and risk assessment directorate: key achievements directorate general for health and consumers (dg sanco): health in the eu. what is in there for you? recent achievements cap on health? the impact of the eu common agricultural policy on public health. 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governance, and supporting coalitions in european union health care policy the hard politics of soft law: the case of health. in health systems governance in europe the open method of co-ordination in action: the european employment and social inclusion strategies collaboration and consultation: functional representation in eu stakeholder dialogues europeanization: new research agendas buchner b: nutrition, obesity and eu health policy a european alcohol strategy submit your next manuscript to biomed central and take full advantage of: • convenient online submission • thorough peer review • no space constraints or color figure charges • immediate publication on acceptance • inclusion in pubmed, cas, scopus and google scholar • research which is freely available for redistribution the paper was partly presented at a symposium held on th june in brussels, belgium, the european public health conference on th november in malta, and a conference on the th anniversary of the eu health mandate on nd may in maastricht, the netherlands. we would like to express our sincere thanks to the experts who invested their time and participated in the interviews. their views and perceptions on european public health policy were highly valued. we would like to thank wilco tilburgs and hassan el fartakh for their support in transcribing the interviews and ann borg for her support and helpful recommendations during the final editing process. we also appreciate the support of our colleagues at the department of international health at maastricht university; in particular kasia czabanowska, matt commers, kai michelsen, christoph aluttis and beatrice scholtes gave advice in setting up and designing the study, questioning the results, or reviewing the manuscript. the authors declare that they have no competing interests. all authors were involved in setting up the study. nr and tc coordinated the study. nr, tc and ks carried out the interviews, performed the analysis, and interpreted the results. nr drafted the manuscript. all authors revised the manuscript and approved the final version. key: cord- -ea a xfl authors: dhama, kuldeep; patel, shailesh kumar; sharun, khan; pathak, mamta; tiwari, ruchi; yatoo, mohd iqbal; malik, yashpal singh; sah, ranjit; rabaan, ali a.; panwar, parmod kumar; singh, karam pal; michalak, izabela; chaicumpa, wanpen; martinez-pulgarin, dayron f.; bonilla-aldana, d. katterine; rodriguez-morales, alfonso j. title: sars-cov- jumping the species barrier: zoonotic lessons from sars, mers and recent advances to combat this pandemic virus date: - - journal: travel med infect dis doi: . /j.tmaid. . sha: doc_id: cord_uid: ea a xfl coronavirus disease (covid- ), caused by sars-cov- (severe acute respiratory syndrome - coronavirus- ) of the family coronaviridae, appeared in china in december . this disease was declared as posing public health international emergency by world health organization on january , , attained the status of a very high-risk category on february , and now having a pandemic status (march ). covid- has presently spread to more than countries/territories while killing nearly . million humans out of cumulative confirmed infected asymptomatic or symptomatic cases accounting to almost million as of july , , within a short period of just a few months. researchers worldwide are pacing with high efforts to counter the spread of this virus and to design effective vaccines and therapeutics/drugs. few of the studies have shown the potential of the animal-human interface and zoonotic links in the origin of sars-cov- . exploring the possible zoonosis and revealing the factors responsible for its initial transmission from animals to humans will pave ways to design and implement effective preventive and control strategies to counter the covid- . the present review presents a comprehensive overview of covid- and sars-cov- , with emphasis on the role of animals and their jumping the cross-species barriers, experiences learned from sars- and mers-covs, zoonotic links, and spillover events, transmission to humans and rapid spread, and highlights the new advances in diagnosis, vaccine and therapies, preventive and control measures, one health concept along with recent research developments to counter this pandemic disease. in the st century, we have faced a few deadly disease outbreaks caused by pathogenic viruses such as bird flu caused by avian influenza virus h n , swine flu caused by reassorted influenza virus h n pandemic (h n pdm ), severe acute respiratory syndrome (sars) caused by sars-cov (coronavirus), the middle east respiratory syndrome (mers) caused by mers-cov [ ] [ ] [ ] , ebola [ ] , zika [ , ] , nipah virus infections, and the most recent threat [ ] , coronavirus disease (covid- ) that has been posed by severe acute respiratory syndrome coronavirus (sars-cov- ) of the family coronaviridae, genus betacoronavirus [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the sars-cov- virus emerged from the city of wuhan, hubei province, china, during december , was declared as public health international emergency by the world health organization (who) on january , . consequently, it was categorized in a high-risk category on february , , and gained the pandemic status on march , . the disease emerged from wuhan, china, as its epicentre, which moved later to italy, then the usa, and brazil. subsequently, within a short time interval of six months, it has affected nearly countries/territories and claimed near to . million human deaths out of cumulative confirmed infected asymptomatic or symptomatic cases accounting to almost million. sars-cov- has very adversely affected the usa, brazil, india, russia, south africa, peru, mexico, chile, spain, the united kingdom (uk), iran, pakistan, saudi arabia, italy and other countries. the disease incidences are lower in children than adults but exhibit all symptoms of a disease like adults [ ] . the lessons learned from earlier threats of sars, mers and the present covid- pandemic situations warrants designing and implementing some modified plans and strategies to combat emerging and zoonotic pathogens that could pose pandemic threats/risks while taking away many human lives [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] . researchers and health agencies across the world are putting high efforts to contain/restrain the spread of this deadly disease. they are pacing to develop potential vaccines and therapeutics/drugs [ , ] . evidence from the initial outbreak indicates earlier cases had links to huanan wholesale seafood market in china [ ] and further isolation of sars-cov- from different samples of the area (people, animals, birds, discharges, soil, structures) suggests the involvement of intermediate hosts [ ] . recently, a literature of review has pointed out the possible potential role of the animal-human interface, zoonotic links and spillover events towards the origin of sars-cov- / covid- [ , , [ ] [ ] [ ] [ ] [ ] . in the past couple of decade's animal origin viral diseases, especially bats-linked, have increased many folds in humans with noted cross-species transmissions. although many of the illnesses are linked with bats still information on their ecological behaviour, molecular aspects are limited, which could lead to more viral outbreaks shortly [ ] . the ongoing covid- pandemic has emphasized the importance of understanding the evolution of natural hosts in response to viral pathogens. in a recent study on ace receptors, the gene was found under intense selection pressure in bats and positive selection in other selected mammalian hosts [ ] . the sars-cov- is also thought to have originated from bats, just like sars-cov and mers-cov. civets and dromedary camels are considered as the intermediate host of sars-and mers-cov, respectively, from where they were transmitted to humans [ ] . the understanding of genomic signatures of sars-cov- with other covs is must for strategic planning through identifying natural or intermediate hosts. using genomic and protein data in a natural vector method (alignment-free approach), phylogenetic analysis revealed the possible transmission path originates from bats to pangolins to humans [ ] . however, the likely source of virus origin and the intermediate host of sars-cov- are yet to be identified. initially, when the novel virus emerged in china, a hypothesis was put forward, claiming the recent recombination event as the cause of the sars-cov- emergence . nevertheless, the phylogenetic and recombination analysis performed within the subgenus of sarbecovirus demonstrated that the novel virus shows discordant clustering with bat-sars-like coronavirus (ratg ) sequences thus rejecting the possibility of a recent recombination event [ ] . previously, it was found that the continuous passaging of mers-cov in non-susceptible cells that express viral receptors led to the accumulation of mutations in the spike protein gene. this paid attention to the potential of coronaviruses like mers-cov to undergo mutations that enhance viral entry into novel animal species, thus resulting in cross-species transmission [ ] . the covid- outbreak is still associated with several unanswered questions like the possibility of shedding of the virus before the onset of clinical signs, whether the transmission is limited to only through respiratory droplets, the possibility of an intermediate host that is responsible for zoonotic spillover, and the possible transmission characteristics [ , ] . hitherto studies report that the spillover risk remains high from zoonotic viruses and on the same lines a study from north america proposed a hypothesized conceptual model demonstrating sars-cov- spillover from humans to naive wildlife host species through the gastrointestinal route where stool from covid- infected patient contaminates water bodies and reaches to wildlife hosts [ ] . besides, the pandemic imposed a massive blow on the chinese economy, which is not going to heal soon [ ] . instead of the current situation, singapore's prime minister lee hsien loong rightly said that the virus might have started in china. however, it does not respect nationality or race. it does not check your passport before it goes into your body, and anybody can be infected. hence, all suspected people need to be tested and quarantined [ ] . further research exploring the sars-cov- associated zoonosis and mechanisms accounting for its initial transmission from animals to humans, will lead to sort out the spread of this virus as well as design and develop appropriate prevention and control strategies to counter covid- . the present comprehensive manuscript presents an overview on covid- , an emerging sars-cov- infectious disease while focusing mainly on the events and circumstantial evidences with regards to this virus jumping the species barriers, sharing a few lessons learned from sars-and mers-covs, zoonotic spillover events (zoonosis), acquiring transmission ability to infect humans, and adopting appropriate preventive and control measures [ ] . it also highlights the recent advances in sars-cov- diagnosis (see supplement material s ), vaccine, drugs and therapies (see supplement material s ), which could aid to counter and restrain this emerging virus at the face of pandemic situations, as well as prevention and control (see supplement material s ). sars-cov- is an enveloped virus measuring approximately - nm in diameter with a single strand positive-sense rna genome ranging from to kilobases in length [ , ] . it has club-shaped glycoprotein spikes in the envelope, giving it a crown-like or coronal appearance [ ] . the genome sars-cov- is comprised of ′ untranslated region ( ′ utr) that includes ′ leader sequence, open reading frame (orf) a/b (replicase genes), spike (s) protein, envelop (e) protein, membrane/matrix (m) protein, and accessory proteins (orf , , a, b, and b), nucleoprotein (n), and ′ untranslated region ( ′ utr) in their sequence [ ] . it has a % genetic identity to mers-cov and % to sars-cov [ , ] . the receptor-binding domain (rbd) of virus spikes helps in binding to cellular receptor angiotensin-converting enzyme (ace- ) [ , ] . orf and rbd of sars-cov- may have a role in elucidating cellular interactions and cross-species transmission mechanisms [ ] . receptor binding motifs (rbm) have a role in interaction with human receptors, human to human transmission, and cross-species transmission as gln provides favourable interaction, and asn shows compatibility with human ace- [ ] . besides, sars-cov- has superior transmission competence in comparison to the sars-cov, leading to a continuously increasing number of confirmed cases [ ] . sars-cov- has the potential to survive in the environment for several days [ ] . though believed to be sensitive to environmental factors and alcohol-based sanitizers, bleach, and chloroform, the sars-cov- can survive in wet surroundings for days and in closed air conditions up to hours [ , ] . survival of sars-cov- varies with the nature of the surface (glass, fabric, metal, plastic, or paper), environment, and virus load. it can survive on surfaces for hours to several days. it can survive in aerosols for up to hours and on plastic for up to hours [ , ] . the initial clinical picture of the covid- was pneumonia of unknown origin as the first clinical cases were presented with signs of pneumonia [ ] . later it was diagnosed as sars-cov- infection that was associated with severe pneumonia. hence, initially named as novel coronavirus pneumonia (ncp) [ ] . as the outbreak proceeded, a series of cases were produced, developing a wide range of clinical signs with few remaining asymptomatic being in the early incubation stage of the disease. thus covid- is characterized by three major patterns of the clinical course of infection, including mild illness producing upper respiratory signs, non-life-threatening pneumonia, and severe pneumonia with acute respiratory distress syndrome (ards) [ , ] . initially, mild signs appear for - days, followed by rapid deterioration and ards. it can be mild to moderate in % of affected cases, including pneumonia and non-pneumonia cases. in comparison, . % are severe cases, including dyspnea, respiratory distress, hemoptysis, gastrointestinal infection, liver, central nervous system, and lung damage cases [ , ] . critical cases account for . % and include respiratory failure, septic shock, and multiple organ failure/dysfunction cases. few cases remain asymptomatic and include cases that can become any of the above during infection [ ] . thus, the symptoms can be nonspecific and can range from no symptoms (asymptomatic) to severe pneumonia [ ] . in this context, a study concluded that the covid- is probably overestimated, as around . million people succumb to respiratory diseases every year in comparison to approximately , deaths due to the sars-cov- infection [ ] . the typical clinical signs of covid- are fever, chills, cough, fatigue, and chest distress [ , ] . fever and cough are considered as the most common symptoms in covid- patients [ ] , followed by headache, dyspnea, sore throat, hemoptysis, myalgia, diarrhoea, nausea, and vomiting are also observed [ , ] . some patients have shown rhinorrhea, chest pain [ ] , nasal congestion [ ] , anorexia, pharyngalgia, and abdominal pain [ ] . furthermore, neurological symptoms like anosmia and ageusia are also reported as significant clinical symptoms of covid- [ ] . the characteristic of covid- is attacking the lower respiratory tract and producing signs of upper respiratory distress, including rhinorrhea, sneezing, and sore throat [ ] . the clinical presentation of individuals infected with sars-cov- revealed upper respiratory tract infection, viremia, viral shedding from the nasopharynx, and stool along with the development of nausea, vomiting or diarrhoea after antiviral treatment [ ] . on diagnostic imaging using computed tomography (ct scan) and radiography (x-ray) bilateral pneumonia, ground-glass opacity, multiple mottling, pneumothorax, infiltration, consolidation or bronchoinflation sign has been noted in many cases of covid- [ , , ] . previously, sars-cov was found to infect the brainstem heavily [ ] . even though fever is considered as the most common symptom associated with covid- infection, a large proportion of the patients do not express fever during the initial hospital admission [ ] . the different transmission routes of sars-cov- infections have not yet been entirely ascertained, and are still under investigation. both direct and indirect pathways of transmission are being explored [ ] . similar to sars and mers, sars-cov- is predominantly spread via the respiratory route [ ] . person to person transmission is the main reason for community and global spread. the initial estimated reproduction number (rovalue) of covid- was assessed to be from . to . in december , which later has been increased to a mean value of . (range . - . ) [ ] . human-to-human transmission is by face-to-face contact with a sneeze or cough, or from contact with secretions of infected people [ , ] . nevertheless, the infectivity of other secretions and excretions are not fully understood and may require further study [ ] . aerosol and plastic surfaces can sustain virus for hours to days [ ] . travelling of infected people is considered as the main reason for the global spread of covid- [ , ] . although the asymptomatic and mild cases are the major hurdle in the evaluation of the real number of infected people, the genuine data on travellers returning from affected countries or areas may prove crucial in estimating the disease incidence [ ] . the possible occurrence of super-spreading events is very high at large gatherings, and suspension of gathering during a pandemic may prove crucial in reducing the overall transmission [ ] . close contact with any person within feet of the covid- patient or anyone having direct contact with secretions of covid- patients [ ] may set up the infection. unlike sars-cov, most transmissions in covid- are during the prodromal period when the infected individuals produce large quantities of virus in the upper respiratory tract, move/travel, and usually work thus spreading virus before illness develops [ ] . the rapid spread of covid- among the susceptible population can be due to the wide variation in illness degrees that results in a missed diagnosis. heavy viral load in asymptomatic cases and nosocomial transmission is spreading covid- unknowingly [ ] . recently, high viral load was detected in the sputum of convalescent patients, pointing out the possibility of prolonged shedding of sars-cov- even after recovery. this finding, along with the fact that asymptomatic persons can also act as the potential source of infection, may warrant a reassessment in the transmission dynamics of the covid- outbreak [ ] . the presence of viral nucleic acids in faeces is an important finding, thereby increasing the possibility of faecal-oral transmission. however, symptoms may or may not be manifested [ ] . this was found to be the unique feature of covid- and was lacking in the previous sars and mers outbreaks. in a study conducted by the chinese cdc, it was found that the majority of patients ( . %) infected with covid- infection were either asymptomatic or had mild pneumonia [ , ] . furthermore, all forms of sexual contacts have been reported to pose a significantly high risk of disease transmission through respiratory aerosols and fomites. however, to date, no evidence of sexual transmission is available, and further investigation is required in this direction [ ] . disease severity is higher in older individuals, especially males with immunocompromised conditions and comorbidities like diabetes, asthma, or cardiovascular diseases [ , ] . these are considered to be vulnerable to the sars-cov- infection. predisposition increases under risk environments where transmission of the virus from affected persons or contaminated fomites to unaffected ones becomes feasible. it was earlier noted that covs are not common to affect immunocompromised patients like other some viral infections (influenza, rhinovirus, adenoviruses, to name a few). the current pandemic has shown sars-cov- to affect more lethally than young patients, mainly destroying the lung tissues [ ] . till now, evidence regarding the higher susceptibility of pregnant women in comparison to non-pregnant women lacks in covid- . also, there is no evidence of vertical transmission (mother to fetus/baby transmission) of covid- infection [ ] . a case study reporting the birth of a healthy infant by a sars-cov- infected woman suggests that mother-to-child transmission is unlikely in the case of covid- . the study also pointed out that on the delivery day, all the samples tested negative except for sputum, which proved positive [ ] . however, as per one most recent report, neonates have been found positive for sars-cov- , indicating the possibility of vertical transmission from infected mothers to their progeny, thus rendering newborns into a high-risk group owing to their immature immune system [ ] . individuals harbouring sars-cov- may remain asymptomatic for the incubation period [ ] . different from sars-cov and mers-cov infection, the median incubation period of covid- was found to be four days [ ] . the median period from the development of signs to death was days [ ] . the case fatality rate (cfr) of covid- was found to be lower than mers and sars [ ] . however, current disease dynamics with the involvement of many more countries or areas may change the future mortality rate. the recent analysis suggests that the total fatality rate of covid- is calculated at . % [ ] . however, italy experienced the worst cfr of more than % with older people and males suffering from multiple comorbidities as primary victims [ ] . sars-cov- has shown characteristics of efficient replication in the upper respiratory tract, causing the less abrupt onset of clinical signs just like the common cold and unlike sars-cov [ ] . it can also replicate in the lower respiratory tract as has been noted in cases without pneumonia but having lesions in the lungs on radiological examination [ ] . the pathogenesis mechanisms of covid- are yet to be fully elucidated. however, both cellular and humoral immune responses against sars-cov- or its antigenic structures like spike protein (s) are believed to be of importance [ , ] with disturbed levels of inflammatory mediators playing a mediating role [ ] . following receptor binding with angiotensin-converting enzyme (ace ) through receptor binding motif (rbm) of the receptor-binding domain (rbd) of s subunit of the sars-cov- spike glycoprotein (s), virus gains entry in host cells [ , , ] . s subunit helps in the fusion of viral and hosts cell membranes [ , ] . sars-cov- produces cytopathic effects in respiratory and gastrointestinal surface epithelial cells [ ] . these include multinucleated syncytial cells, abnormally enlarged pulmonary cells, infiltration with mononuclear cells, lymphocytes infiltration in pulmonary organs, fibrinous exudation, and hyaline deposition [ ] . cytokine storm is believed to be involved in this inflammatory pathophysiology of the covid- patients producing lung lesions and systemic symptoms [ ] . elevated levels of tnf-α, il b, ifnγ, ip , gcsf, mip a, and mcp , may have stimulated t-helper- (th ) cells leading to this inflammatory cascade [ ] . however, levels of anti-inflammatory mediators (il , il ) were also increased, indicating t-helper- (th ) stimulation, which suppresses inflammation, unlike what happens in sars [ ] . a study documented that the nucleic acid of sars-cov- detected in the faecal samples was as accurate as of that of pharyngeal samples obtained from infected patients. moreover, the patients tested positive for sars-cov- in stool showed no gastrointestinal symptoms and had no relation to the severity of lung infections [ ] . one of the significant clinical signs of covid- patients during the initial presentations was gastrointestinal symptoms. hence, the involvement of git in pathogenesis needs to be explored. the significant laboratory findings include lymphopenia, increased values of erythrocyte sedimentation rate, c-reactive protein, lactate dehydrogenase, and decreased oxygenation index [ ] . an increase in proinflammatory cytokine and a decrease in antiinflammatory cytokines have also been noted [ ] . viral isolation has been achieved from bronchoalveolar lavage of affected persons; however, in the case of pregnant women, serum, faeces, urine, breast milk, umbilical cord blood, placenta, and amniotic fluid were found to be negative for sars-cov- [ ] . at the same time, the sputum was tested positive [ ] . the presence of abnormal coagulation parameters in patients with severe novel coronavirus pneumonia was associated with poor prognosis. the non-survivor patients had higher levels of d-dimer, and fibrin degradation product (fdp) along with longer activated partial thromboplastin time and prothrombin time compared to survivors at the time of admission [ ] . though clinical manifestations, pathological changes, and diagnostic laboratory findings can unravel the disease nature helping in devising therapeutic modalities, however, for epidemiological aspects and future prevention and control, simultaneous tracing of the origin and explaining the spillover events can prove beneficial. the sars-cov- has first been reported from the pneumonia patients of the wuhan city in hubei province of china. these patients were involved in trading at a wet animal market in the huanan area. it is believed that sars-cov- is introduced from the animal kingdom to human populations during november or december , as revealed from the phylogeny of the genomic sequences from the initially reported cases [ ] . the spillover of sars-cov- from animals to humans took place at the beginning of december [ ] , and the clinical cases appeared around ending december [ , ] . genetic analysis showed that this novel virus is closely related to bat covs and is similar but distinct from the sars virus [ ] . several evidences based on genome sequences, the homology of the ace receptor, and the presence of single intact orf on gene indicate bats as a natural reservoir of these viruses. however, an unknown animal is yet to be unravelled as an intermediate host [ , , , , ] . initial investigations on animal source origin of sars-cov- have inconclusively revealed snakes [ ] , pangolins, and turtles [ ] . the rapid spread of covid- followed the initial animal to human spillover through human-to-human transmission. genetic epidemiology had revealed that the spread from the beginning of december when the first cases were retrospectively traced in wuhan was mainly by a human-to-human transmission and not due to continued spillover [ ] . these species cross jumping, spillover, and rapid transmission events are linked to viral characteristics, host diversity, and environmental feasibility. coronaviruses being rna viruses have high mutation rates that, besides creating new strains, enable them to adapt to a wide range of hosts. hence, based on genome sequences, all known human covs have emerged from animal sources [ ] . this seventh member of the human cov has also been isolated initially from the pneumonia patients who were having direct or indirect links to the huanan seafood market in wuhan china, wherein other animals were also being sold [ ] . these include a -year-old lady retailer in this wet animal market, a -year-old frequent visitor to this market, and a -year-old man [ , ] . further, isolation of the sars-cov- from the environmental samples around this market, including people, animals, soil, discharges, or structures, strengthens the claims of involvement of hosts either as a reservoir or intermediate [ , , ] . recently, a pomeranian dog as a probable intermediate host was identified; however, such reports are yet to be validated, and research is underway to explore the emergence of this infectious disease at the animal-human interface [ , ] . multiple substitutions were observed in ace receptors of a dog [ ] . in this context, the pomeranian dog of the infected owner found positive for covid- suggest the permissiveness of the species for sars-cov- as a result of species jumping [ , ] . among the fifteen dogs tested from different households with confirmed human covid- cases in hong kong sar, two dogs were found to be infected with sars-cov- . the diagnosis was made using quantitative rt-pcr, serology, and viral genome sequencing. virus isolation was also done from the samples obtained from one dog. the genetic sequences of viruses obtained from the two dogs were identical to the ones that were detected from their human cases indicating human-to-dog transmission [ ] . moreover, a study reported that the sars-cov- might infect the cats and further transmitted by the infected cat to other cats [ ] . one cat was tested positive for sars-cov- in france that showed mild respiratory and digestive signs. the cat was tested positive by rt-qpcr on the rectal swab, and serological analysis identified the presence of antibodies against sars-cov- . genome analysis further confirmed that the sars-cov- isolated from the cat belongs to the phylogenetic clade a a seen in french human indicating humanto-animal transmission [ ] . this is not the first time that a domestic cat has been found susceptible to zoonotic coronavirus. during the sars-cov outbreak, domestic cats were tested positive for sars-cov that were living near sars infected humans [ , ] . even though experimental evidence indicates the possibility of sars-cov- transmission from infected to a susceptible cat close, sars-cov- transmission between cats or cat-tohumans are not reported under natural conditions [ ] . furthermore, along with dogs and cats, the zoo animals like tigers and lions were also reported to get the sars-cov- infection and exhibit clinical signs such as vomiting, diarrhoea, dry cough, breathing difficulty and wheezing [ , ] . spillover of sars-cov- was also reported in mink farms of netherlands, further increasing the concern of transmission to humans. outbreaks of sars-cov- were reported in two mink farms holding , and animals. the virus is suspected to be introduced by a farmworker having covid- [ , ] . host-pathogen interactions and pathogenesis determine the severity and expression of disease [ , [ ] [ ] [ ] . adaptation over time reduces the severity of infection as happened with hcovs; however, the emergence of novel viruses or strains due to genetic alterations or recombinations can enhance hardness producing novel diseases like covid- [ , ] . evolutionarily, the balance of viral-human interaction and immune response against virus enables adaptation, thereby persistence in a host without severe or symptomatic disease when the aggravated pathogenesis results in mortality. hence, loss of sustainable hosts and transmission to novel hosts becomes inevitable for future sustainability [ , ] . a pathogen cannot kill all its hosts, and for future sustainability, it adapts to some suitable host or spills over to a new host. sars-cov- has been implicated to be originated from animals, and associated with animal linkages, spillover events, cross-species barrier jumping and zoonosis [ , , , [ ] [ ] [ ] ] . since the beginning of till the end of , three coronaviruses viz. sars-cov, mers-cov, and sars-cov- have caused havoc in the human population globally and will continue to do so. earlier identified betacoronaviruses (sars-cov and mers-cov) were reported in guangdong province of china in november and saudi arabia in , respectively [ ] . sars-cov- is the third zoonotic betacoronaviruses recognized in this century. however, the cfr of the sars-cov- is lower to date when compared with sars and mers. it should not be overlooked as many asymptomatic cases may remain undiagnosed due to the unavailability of diagnostic kits in china. with nearly . million deaths till the preparation of the manuscript, sars-cov- is proven to be deadliest as far as the number of deaths is concerned in comparison with sars-cov and mers-cov with and associated deaths, respectively [ , ] . earlier, covid- was linked with the exposure to the huanan seafood market. however, individuals with no history of exposure above were also diagnosed with the illness, further supporting the human to human spread through droplets produced by cough and sneeze [ ] . the spread of covid- that occurred with a high pace and lack of transparency in reporting the disease by the chinese health ministry and failure in the timely implementation of preventive measures has been considered as the primary contributor as stated earlier in sars [ , ] . both sars-cov and sars-cov- showed prominent similarities in their pathogenesis and epidemics. in both cases, bats were considered as the natural host, and the cold temperature and low humidity in cold, dry winter provided conducive environmental conditions that promoted the survival of the virus in the environment [ ] . further, moriyama et al. [ ] assessed the significance of the environmental factor on host immune system targeting innate and adaptive both responses in the respiratory tract. zoonotic spillover is the transmission of pathogens to humans from vertebrate animals [ ] . at present, these spillovers are of significant concern as in the past, many spillovers in the form of nipah, hendra, ebola, sars, mers, and ongoing covid- involving many animal species like pigs, horses, monkeys, camels, civets, among others, were documented. bovine covs have been reported to infect children and thus possess zoonotic potential [ , , , ] . spillover is governed by the interaction of viral-specific proteins like s protein and host ace receptor [ , , , ] . these s proteins have rbd in covs, which contain receptor binding motifs (rbm) that help in specific binding to host ace receptors [ , ] . mutations in amino acid sequences of rbds results in a change in specificity of a receptor, interaction and binding, hence alteration in transmissibility, pathogenicity and cross-species jumping with a predisposition to novel and more severe diseases [ , ] . in the case of sars-cov- , rbd of s protein has - times affinity ace r [ , ] . it has furin recognition sequence "rrar" at the s -s cleaving site that represents a functional site for the cellular serine protease tmprss thus increasing the efficiency of transmission and contagiousness [ , , ] . in addition to enhanced binding affinity, electrostatic complementarity and hydrophobic interactions are critical to enhancing receptor binding and escaping antibody recognition by the rbd of sars-cov- , thereby further increasing transmission capability and contagiousness [ ] . a detailed investigation regarding the emergence of new coronavirus, host range, and transmissibility is crucial to understand such pandemics shortly. the literature revealed that before the appearance of sars-cov and mers-cov, human coronavirus (hcov) strains like hcov-nl , hcov- e, hcov-oc , and hcov-hku were the covs strains producing mild infections in humans. however, their natural ancestral hosts were of animal origin, like bats for hcov-nl , and hcov- e and rodents were natural hosts for hcov-oc and hku . these four hcovs were initially of low pathogenicity. to enhance the pathogenicity, they used intermediate hosts such as cattle for hcov-oc (natural host was rodent), and alpacas for hcov- e (bats were natural host) and this way acquired the ability to infect human beings with serious health hazards [ ] . added to the involvement of bats and pangolins, the recent reports revealing sars-cov- infection in cats, dogs, tigers, lions and minks have raised concerns over this virus affecting multiple animal species, and also points out towards the incidences of reverse zoonosis [ , , , , , ] . the ferrets, cats, and primates are suggested to be good candidates for susceptibility to sars-cov- [ , ] . covid- research and surveillance in companion and pet animals, livestock animals, zoo animal species, wildlife animal species as well as their handlers, veterinarians, and owners need to be enhanced during the pandemic, which would help to follow better integrated one health strategies [ ] and appropriate preventive and mitigation to counter sars-cov- effectively [ , , [ ] [ ] [ ] [ ] [ ] . significance of covid- monitoring and implementation of suitable public health measures among workers involved in meat and poultry processing facilities/industries has been emphasized, which would protect them as well as aid in preserving the critical meat and poultry production infrastructure and the meat products [ ] . the involvement of intermediate hosts in maintaining and transmitting the virus to susceptible host predisposes humans to novel covs leading to the emergence of new diseases in humans. the currently ongoing sars-cov- / covid- pandemic has put on hold the entire world [ , ] . the covs have frequently been associated with animal and human diseases and have a zoonotic interface [ , ] . usually, one or more types of animal hosts are involved in the transmission cycle of covs to humans [ , ] . that can be natural host, reservoir host, intermediate host or definitive host [ ] . bats have been the natural hosts for human covs of alphacoronavirus (hcov-nl , hcov- e) and betacoronavirus (sars-cov, mers-cov, sars-cov- ) genera whereas for betacoronavirus members hcov-oc and hcov-hku , rodents are the natural hosts. genome sequence analysis has revealed bats as a natural host for sars-cov- [ , ] . in natural or reservoir hosts, covs adapts well, however, being unstable rna viruses, they keep multiplying continuously without producing disease thereby enabling persistence or survivability and accumulation of mutations over the time resulting in the emergence of newer and novel strains of viruses [ , , ] . these unique strains or viruses occasionally spill over to other species including animals or humans, adapting to their body systems and hence broaden the biological host range for evolutionary sustainability; however, results in epidemiological widening of disease sphere as well [ , ] . this transmission and adaptation scenario initiates a host-pathogen response resulting in the novel usually severe diseases that can at times be fatal in initial stages or over extended periods until virus pathogen adapts to host or the host develops sufficient immune defence [ , ] . it has been reported that almost all hcovs have originated from animals like bats (sars-cov, mers-cov, hcov-nl , and hcov- e) and rodents (hcov-oc and hku ) [ , ] . additionally, covs have been reported to infect several species of domestic and wild animals either clinically or subclinically [ , , , ] . cattle, horses, camels, swine, dogs, cats, birds, rabbits, rodents, ferrets, mink, bats, snakes, frogs, marmots, hedgehogs, malayan pangolin along with other wild animals may serve as a reservoir host of coronavirus [ , , , , [ ] [ ] [ ] [ ] [ ] [ ] . in the context of sars-cov- , snakes, pangolins and bats have been suspected as intermediate hosts since the first cases of covid- had links to huanan sea food market where different animals, birds, and wild animals were being sold along with seafood items [ , , , , , ] . coronaviruses have been reported to cause salivary, enteric and respiratory infections in laboratory animals (mice, rat, guinea pig, and rabbit) and urinary tract infection, respiratory illness and reproductive disorder in poultry [ , ] . in bovine, canine, feline and swine covs infections have resulted in diarrhoea, enteritis, respiratory illness, gastro-intestinal affections and nervous symptoms [ , , [ ] [ ] [ ] . coronavirus, namely-sw , has been reported in captive beluga whale using a panviral microarray method [ ] . among all the assumptions on animal hosts as the intermediate host, genomic and evolutionary information from pangolins reveals the highest closeness to the sars-cov- than any other host covs isolates [ ] . the spike protein, the main target of many studies searching for a cure of covid- , has been found highly similar to sars-cov- and, thus, could serve as a surrogate system for further evaluations [ ] . bats are the natural reservoir host of many covs. as reported earlier, out of alphacoronaviruses and out of betacoronaviruses as per the international committee on taxonomy of viruses (ictv) classification were solely originated from bats [ , ] . according to the literature, bats have been regarded as a potential wildlife reservoir whereas civets and dromedary camels as intermediate hosts of sars-cov and mers-cov, respectively [ , ] . the bat coronavirus, batcov ratg , has shown higher relatedness to sars-cov- at the whole genome level and spike gene in particular [ ] . coexistence and frequent recombination between highly diversified and prevalent bat sars-related coronaviruses (sarsr-cov) and coronaviruses may suggest the probable emergence of novel viruses shortly [ , ] . benvenuto et al. [ ] analyzed the whole genome sequences of different covs using fast unconstrained bayesian approximation (fubar) to understand the evolutionary and molecular epidemiology of sars-cov- . the authors concluded that sars-cov- clustered with sequences of bat sars-like covs with a few mutations in nucleocapsid and spike glycoprotein, suggesting its probable transmission from the bats [ ] . bats, especially horseshoe bats (rhinolophus spp.), are considered to be the known reservoirs of sars-related covs. since the bat origin, covs have always caused outbreaks in humans, studying the diversity and distribution of coronavirus populations in the bats will help to mitigate future outbreaks in humans and animals [ ] . interestingly, bats play a crucial role in all the spillovers mentioned above, indicating their importance in the emergence of new viruses. the reason behind the emergence and broad host range of covs in the past and present might be due to unstable rna-dependent rna polymerase (rdrp), lack of proof-reading ability, high frequency of mutations in the receptor-binding domain of spike gene and genetic recombination [ , , ] . bat covs have high diversity and great potential of spillover in different animal species, as reported earlier in civet cat and dromedary camel, leading to well-known pandemics sars and mers, respectively along with the recent spillover in pigs resulted in swine acute diarrhoea syndrome (sads). however, spillover resulted in the emergence of sads-cov, which showed a % genomic identity with bat coronavirus, which led to severe mortality with , deaths in neonatal piglets [ ] . fortunately, it did not excel in the form of the third pandemic, and no human cases were reported till date. the spillover responsible for ongoing covid- is still under investigation and a matter of great concern for the researchers all around the globe. based on resampling similarity codon usage (rscu), snakes (bungarus multicinctus and naja atra) were suggested as wildlife reservoirs of sars-cov- and reported to be associated with the cross-species transmission [ ] and later it was disapproved by other researchers [ , ] . unfortunately, to date, the intermediate host of the sars-cov- is abstruse what results in its escalation in the human population around the globe. in this context, analyzing the interaction between the asn site in rbd of spike glycoprotein of sars-cov- and the residue at sites of ace receptor of different hosts (pangolins, turtle, mouse, dog, cat, hamster and bat) revealed that tyrosine has higher receptor binding affinity than histidine suggesting pangolins and turtle be closer than bats to humans and maybe the probable intermediate hosts of sars-cov- [ ] . however, this hypothesis was also contradicted by li et al. [ ] based on an insertion of the unique peptide (prra) in the sars-cov- virus, which was lacking in covs from pangolins. moreover, sars-cov- showed higher similarity to the betacov/bat/yunnan/ratg / compared to the ones that were isolated from the pangolins, thereby denied the direct link of the virus from pangolins. however, further studies are required to confirm the role of pangolins in sars-cov- spread to humans. the receptor-binding domain of the spike protein of sars-cov interacts with the host receptor ace facilitating its potential of cross-species, as well as human-to-human transmission [ ] . similarly, the spike protein of sars-cov- was reported to recognize ace receptors expressed in fish, amphibians, reptiles, birds, and mammals and has a more robust binding capacity (affinity) in comparison to sars-cov [ ] . this suggests their involvement as probable natural and intermediate hosts [ ] , which may further help in the selection of animal models for epidemic investigation and preventing its spread [ ] . bat origin covs have been found to cross the species barrier that favoured their transmission via recombination/mutations in the rbd. the evidence of a virus outbreak that occurred in chinese pig farms suggests its possible cross-species [ , ] . also, murine cells were found permissive for sars-cov after substitution of his with lys in the ace receptor of a mouse, which suggests the role of residue changes in the cross-species and human-to-human transmission [ ] . mutation in residues at position and of receptor binding motif (rbm) of sars-cov was reported to play a role in civet-to-human and human-to-human transmission, respectively [ , ] . the covs are more prone to recombination and mutations leading to variable host range, and resemblance of receptors in various hosts results in cross-species jumping [ , , ] . genetic divergence due to these genetic alterations results in the evolution of newer viral strains having altered virulence, tissue tropism, and host range [ , ] . moreover, the presence of threonine at position was reported to enhance the binding affinity of rbm for the ace receptor of civet and humans [ ] . however, many sarsrelated coronaviruses (sarsr-cov) have been reported in bats and used ace receptors for entry into a host cell, which showed its potential to infect humans directly without any intermediate host [ ] . in addition to this, no direct transmission of sarsr-cov is reported from bats to humans to date. however, seropositivity on a serological investigation of individuals without prior exposure to sars-cov residing near bat caves in china revealed likely infection of humans by bat sarsr-cov and related viruses [ ] . besides, the interspecies transmission potential of sarsr-covs is due to the orf gene [ ] . as per reports, the sars-cov emerged via recombination of bat sarsr-covs, was transmitted to farmed civets along with other mammals, and these infected civets spread the virus to market civets. the virus was reported to undergo mutations in infected market civets before its spillover to humans. similarly, the mers-cov circulated for years in camels before the pandemic [ , ] supporting the hypothesis that after species jumping the exogenous viruses opted for adaptation to the environment and host before spillover to humans [ ] . moreover, the possible spillover of other circulating bat sarsr-covs to humans from mammalian hosts soon is highly anticipated. the cross-species jumping and adaptation are determined by the presence of specific receptors on host tissues (like ace receptor for hcov-nl , sars-cov and sars-cov- , dipeptidyl peptidase- for mers-cov, human aminopeptidase n for hcov- e, -oacetylsialic acids for hcov-oc , hcov-hku ) which help in binding and entry of the virus into host cells [ , ] . these receptors are present in various body systems in animals and humans, including respiratory and gastrointestinal systems [ ] . reservoir host animals including bats and rodents possess these receptors which are similar to those present in camels, masked palm civets (paguma larvata), or bovines, that act as an intermediate host for different covs [ , , ] . presence of some of these receptors in humans like ace or dpp makes them vulnerable to cov infection like sars-cov and mers-cov causing sars and mers infections, respectively [ , ] . the mers-cov spike was found to possess the capacity for adapting to species variation in the host receptor dpp [ ] . the mechanism expressed by mers-cov in adapting to infect cells of new species might be present in the other coronaviruses. ace has also been found as a binding receptor for sars-cov- [ ] . the species-specific variations in the host receptors limit the interaction with cov spike protein, and this is responsible for the development of the species barrier that prevents spillover infection. snakes, civets, and pangolins are considered as the potential intermediate hosts of covid- . however, further confirmation is required by tracking the origin of the virus. this is critical for preventing additional exposure to this fatal virus [ ] . the probability of the sars-cov- spread during incubation and convalescent period has been suggested [ ] . as per reports, presence of covs has been observed in respiratory droplets, body fluids and inanimate objects with the ability to remain infectious for nine days on contaminated surfaces resulting in its risk of self-inoculation via mucous membranes of the eyes, mouth or nose [ ] [ ] [ ] . nosocomial, as well as human-to-human transmission, have been reported to occur via virus-laden aerosols, contaminated hands or surfaces, and close community contact with an infected person [ , , ] . the ocular route has been reported in the human-to-human transmission of sars-cov- , as observed in sars-cov, suggesting the involvement of different ways other than the respiratory tract [ , ] . later on, the probability of the faecal-oral route for potential transmission of the virus was also suggested [ ] . the metatranscriptome sequencing of sars-cov- in the bronchoalveolar lavage fluid (balf) of infected individuals resulted in polymorphism in few intra-hosts variants, suggesting the in vivo evolution of the virus thereby affecting its virulence, transmissibility, and infectivity [ ] . an overview of coronaviruses jumping the cross-species barriers, zoonotic covs transmitted from bats to animals before spillover to humans, and possible prospects for further transmission to mammalian hosts is depicted in figure . the first two decades ( - ) of st century have proven a nightmare for the countries around the globe considering the coronavirus zoonosis, including the ongoing crisis of covid- which has involved entire fields of global [ , ] . the countries affected severely by previous covs were even not evolved entirely from the effects of sars and mers when the covid- struck almost the entire world. novel coronavirus sars-cov- has shaken all the sectors of the countries irrespective of being developed or underdeveloped including healthcare system, economics, trade, infrastructure, service and production sectors [ , ] . being a zoonotic disease with still unknown intermediate host, undisclosed features of a novel viral pathogen, unclear modes of transmission and ecological aspects, less explored pathogenesis and substantial morbidity and considerable mortality, the safety of all is a matter of great concern, and thus the involvement of various authorities was sought since the inception of disease [ , , , ] . the first time the need for one health concept has risen to a level that authorities in various countries implemented coordinated approaches between medical, veterinary, public health, wildlife, food safety, environmental departments and so on [ ] [ ] [ ] . that involved acquiring suggestions, diagnosis and prevention and treatment measures and their implementation in collaboration. non-medical staff in association with the medical staff was employed for initial screening, quarantine, contact tracing when the expertise of molecular biologists or technicians from various disciplines was used in the laboratory diagnosis. medical staff provided the cure and management of the patients when the public health departments, including public health engineering, municipality, food and supplies ensured sanitation, hygiene, food supply and safety. imposing of lockdown was provided by security personnel's and the transport department facilitated the movement of stranded people. thus, this crises management strategy involved various agencies directly or indirectly. however, as the animal, human and environmental health is linked to one another, the prime and future efforts should primarily focus on all these aspects. in addition to regular hand hygiene, respiratory etiquette, social/physical distancing, use of personnel protective equipment (ppe) and food safety recommendations, one health approach encompasses the role of veterinary, medical and environmental specialists for the prevention and control of current covid- crises and investigating the animal origin of covid- , regulating and limiting the sale and farming of wildlife species for food and taking a one health approach to food systems feeding the world for the prevention of future pandemics [ , , ] . considering the contagiousness of the virus, discouraging the working of affected individuals, public health hygiene strategies, and social distancing has been recommended as preventive measures [ , ] . food hygiene and safety, as recommended by oie [ ] and usda [ ] , should be followed. as the viral survivability has been demonstrated on various surfaces [ ] hence disinfection by using recommended disinfectants is necessary [ ] . environmental hygiene and cleanliness are also essential [ ] . interaction with animals and improper utilization of animal products during an outbreak should be avoided [ ] . though the one health involves mainly public health, animal health and environmental experts, however, for the successful management of current crises and future prevention and control requires the participation of all concerned sectors having a role in public health measures, identifying clinical cases, diagnosis, contact tracing, proper infection control in various settings, isolation, quarantine, cure and management, public awareness, facilitation of infrastructure and other facilities through local administrations [ , ] . as the human covid- cases are on the rise due to efficient human-to-human transmission, there is a subsequent rise in the natural infections of covid- among the companion and wild animal species owing to the spillover. this is mainly because of the specific biological and virological characteristics of coronaviruses that gives them the ability to easily cross-species barriers [ ] . even though animal-to-human transmission is not reported in covid- , 'one health' approach is necessary to control this pandemic virus a schematic illustration of covid- clinical signs, modes of transmission, important diagnostic methods, and advances in vaccine development along with salient prevention and control strategies are presented in figure . with the rising number and worldwide spread of covid- , the need for global efforts rely heavily on the investigations carried out at infection sites to trace different aspects of this novel coronavirus outbreak. one of the critical facets and the earliest research must involve determining the root cause, origin, and source of this emerging infectious disease. shreds of evidence have revealed various cross-species jumping or spillover from animals to humans of these zoonotic coronaviruses. detailed serological investigation of all domestic and wild animals residing in the proximity to humans is of utmost necessity to know and prevent likely spillover of many other bat-related covs in the future. rapid detection of spillovers above will only be possible by the implementation of an effective and robust surveillance system for circulating viruses with high zoonotic potential in animals. besides, detection of a pathogen while crossing the species barrier to start circulation among humans and prevention of human-to-human transmission in early-stage may prove crucial in termination of a probable epidemic or pandemic. application of 'one health' concept involving medical, veterinary, wildlife, public health, and other related professionals may help in infection tracing, exploring risk factors and predisposition, minimizing risk to susceptible ones, and finally devising better prevention and control strategies. in the initial stages of the covid- outbreak, the steps taken for implementing stringent control and preventive measures have bought us some time. this time has to be efficiently utilized for developing sars-cov-specific therapeutic drugs and vaccines that can prevent the further spread of this fatal pathogen. for the time being early 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to help prevent another animal-to-human virus pandemic prevention cfdca. covid- and animals usda ensures food safety during covid- outbreak disinfectants for use against sars-cov none. key: cord- -pwe zoi authors: singh, dr shweta; roy, assistant professor.miss deblina; sinha, clinical psychology trainee miss krittika; parveen, clinical psychology trainee miss sheeba; sharma, clinical psychology trainee. ginni; joshi, clinical psychology trainee. gunjan title: impact of covid- and lockdown on mental health of children and adolescents: a narrative review with recommendations. date: - - journal: psychiatry res doi: . /j.psychres. . sha: doc_id: cord_uid: pwe zoi background: covid- pandemic and lockdown has brought about a sense of fear and anxiety around the globe. this phenomenon has led to short term as well as long term psychosocial and mental health implications for children and adolescents. the quality and magnitude of impact on minors is determined by many vulnerability factors like developmental age, educational status, pre-existing mental health condition, being economically underprivileged or being quarantined due to infection or fear of infection. aims: this paper is aimed at narratively reviewing various articles related to mental-health aspects of children and adolescents impacted by covid- pandemic and enforcement of nationwide or regional lockdowns to prevent further spread of infection. methodology: we conducted a review and collected articles and advisories on mental health aspects of children and adolescents during the covid- pandemic. we selected articles and thematically organized them. we put up their major findings under the thematic areas of impact on young children, school and college going students, children and adolescents with mental health challenges, economically underprivileged children, impact due to quarantine and separation from parents and the advisories of international organizations. we have also provided recommendations to the above. conclusion: there is a pressing need for planning longitudinal and developmental studies, and implementing evidence based elaborative plan of action to cater to the psycho social and mental health needs of the vulnerable children and adolescents during pandemic as well as post pandemic. there is a need to ameliorate children and adolescents’ access to mental health support services geared towards providing measures for developing healthy coping mechanisms during the current crisis. for this innovative child and adolescent mental health policies policies with direct and digital collaborative networks of psychiatrists, psychologists, paediatricians, and community volunteers are deemed necessary. this paper is aimed at reviewing articles related to mental-health aspects of children and adolescents impacted by covid- pandemic and lockdowns. there is a need to carry out longitudinal and developmental studies and plan strategies to enhance children's and adolescent's access to mental health services during and after the current crisis. for this direct and digital collaborative network of psychiatrists, psychologists, pediatricians, and community volunteers are of vital importance. background: covid- pandemic and lockdown has brought about a sense of fear and anxiety around the globe. this phenomenon has led to short term as well as long term psychosocial and mental health implications for children and adolescents. the quality and magnitude of impact on minors is determined by many vulnerability factors like developmental age, educational status, pre-existing mental health condition, being economically underprivileged or being quarantined due to infection or fear of infection. aims: this paper is aimed at narratively reviewing various articles related to mental-health aspects of children and adolescents impacted by covid- pandemic and enforcement of nationwide or regional lockdowns to prevent further spread of infection. methodology: we conducted a review and collected articles and advisories on mental health aspects of children and adolescents during the covid- pandemic. we selected articles and thematically organized them. we put up their major findings under the thematic areas of impact on young children, school and college going students, children and adolescents with mental health challenges, economically underprivileged children, impact due to quarantine and separation from parents and the advisories of international organizations. we have also provided recommendations to the above. conclusion: there is a pressing need for planning longitudinal and developmental studies, and implementing evidence based elaborative plan of action to cater to the psycho social and mental health needs of the vulnerable children and adolescents during pandemic as well as post pandemic. there is a need to ameliorate children and adolescents' access to mental health support services geared towards providing measures for developing healthy coping mechanisms during the current crisis. for this innovative child and adolescent mental health policies policies with direct and digital collaborative networks of psychiatrists, psychologists, paediatricians, and community volunteers are deemed necessary. key words: covid- ; lockdown; mental health; children; adolescents there are more than . billion children in the world who constitute approximately % of the world's population. those aged between to years make up % of the world's population (unicef, ) . covid- has impacted the lives of people around the world including children and adolescents in an unprecedented manner. throughout the world, an essential modus of prevention from covid- infection has been isolation and social distancing strategies to protect from the risk of infection (shen et al., ) . on these grounds, since january, , various countries started implementing regional and national containment measures or lockdowns. in this backdrop one of the principal measures taken during lockdown has been closure of schools, educational institutes and activity areas. these inexorable circumstances which are beyond normal experience, lead to stress, anxiety and a feeling of helplessness in all. it has been indicated that compared to adults, this pandemic may continue to have increased long term adverse consequences on children and adolescents (shen et al., ) . the nature and extent of impact on this age group depend on many vulnerability factors such as the developmental age, current educational status, having special needs, pre-existing mental health condition, being economically under privileged and child/ parent being quarantined due to infection or fear of infection. the following sections discuss about findings of studies on mental-health aspects of children and adolescents impacted by covid- pandemic and lockdowns being implemented at national or regional levels to prevent further spread of infection. we searched the electronic data bases of medline through pubmed, cochrane library, science-direct and google scholar databases, from january, till june, . we carried out the search with the following methods like, mesh or free text terms and boolean were done by five independent reviewers. a manual search was also conducted of the references of the related articles to gather information about the relevant studies. initial pubmed search with the term with " covid- in children" showed only results. among these, only four articles were related to "psychological effects of covid in children". therefore in order to make the review more comprehensive and informative, we also included studies that reported the effect on older children and impact of covid - on their lives. this was done keeping in mind the varied terminologies used to describe the phenomenon of 'children and covid- ". after using the above strategy, our search showed results. only articles in english language peer reviewed journals were included. grey literature such as conference proceedings were not included due to possibility of insufficient information. we included case studies and review articles and advisories by the who (world health organization), apa (american psychiatric association) and nhs ( national health services) and government of india ministry of health. based on these inclusion criteria we included articles. three independent authors participated in study selection and all authors reached a consensus on the studies to be included. being a narrative review, we did not attempt computation of effect sizes or do a risk of bias assessment for included papers. the studies included were categorized under eight headings divided in various thematic sections and discussed with studies and reports found. the data is qualitatively analysed and reported in the paper. a summary of the papers included in this narrative review is presented in table . [ table is uploaded seperately] impact on young children: stress starts showing its adverse effect on a child even before he or she is born. during stress, parents particularly pregnant mothers are in a psychologically vulnerable state to experience anxiety and depression which is biologically linked to the wellbeing of the foetus (biaggi et a ; kinsella and monk, ). in young children and adolescents the pandemic and lockdown have a greater impact on emotional and social development compared to that in the grown-ups. in one of the preliminary studies during the on-going pandemic, it was found younger children ( - years old) were more likely to manifest symptoms of clinginess and the fear of family members being infected than older children ( - years old). whereas, the older children were more likely to experience inattention and were persistently inquiring regarding covid- . although, severe psychological conditions of increased irritability, inattention and clinging behaviour were revealed by all children irrespective of their age groups (viner et al., a) . based on the questionnaires completed by the parents, findings reveal that children felt uncertain, fearful and isolated during current times. it was also shown that children experienced disturbed sleep, nightmares, poor appetite, agitation, inattention and separation related anxiety (jiao et al., ) . globally, the pre-lockdown learning of children and adolescents predominantly involved one-to-one interaction with their mentors and peer groups. unfortunately, the nationwide closures of schools and colleges have negatively impacted over % of the world's student population (lee, ). the home confinement of children and adolescents is associated with uncertainty and anxiety which is attributable to disruption in their education, physical activities and opportunities for socialization (jiao et al., ) . absence of structured setting of the school for a long duration result in disruption in routine, boredom and lack of innovative ideas for engaging in various academic and extracurricular activities. some children have expressed lower levels of affect for not being able to play outdoors, not meeting friends and not engaging in the in-person school activities (lee, ; liu et al., ; zhai & du, ) . these children have become more clingy, attention seeking and more dependent on their parents due to the long term shift in their routine. it is presumed that children might resist going to school after the lockdown gets over and may face difficulty in establishing rapport with their mentors after the schools reopen. consequently, the constraint of movement imposed on them can have a long term negative effect on their overall psychological wellbeing (lee, ). a study found that older adolescents and youth are anxious regarding cancellation of examinations, exchange programs and academic events (lee, ) . current studies related to covid- demonstrate that school shut downs in isolation prevent about - % additional deaths which is quite less if compared to usage of other measures of social distancing. moreover, they suggest to the policy makers that other less disrupting social distancing strategies should be followed by schools if social distancing is recommended for a long duration (lee, ; sahu, ; viner et al., a) . however, in current circumstances, it is controversial whether complete closure of school and colleges is warranted for a prolonged period. it has been reported that panic buying in times of distress indicate an instinctual survival behaviour (arafat et al., ) . in present pandemic era there has been a rise in the hoarding behaviour among the teenagers (oosterhoff et al., a) . it is also found that among youth social distancing is viewed primarily as a social responsibility and it is followed more sincerely if motivated by prosocial reasons to prevent others from getting sick (oosterhoff et al., a) . further, due to prolonged confinement at home children's increased use of internet and social media predisposes them to use internet compulsively, access objectionable content and also increases their vulnerability for getting bullied or abused (cooper, ; unicef, b) . worst of all, during lockdown when schools, when legal and preventative services do not functioning fully, children are rarely in a position to report violence, abuse and harm if they themselves have abusive homes. there are about in every children within the age group of - years who have some or the other neurodevelopmental, behavioural or emotional difficulty (cdc, ). these children with special needs [autism, attention deficit hyperactivity disorder, cerebral palsy, learning disability, developmental delays and other behavioural and emotional difficulties] encounter challenges during the current pandemic and lockdown (cdc, ). they have intolerance for uncertainty and there is an aggravation in the symptoms due to the enforced restrictions and unfriendly environment which does not correspond with their regular routine. also, they face difficulties in following instructions, understanding the complexity of the pandemic situation and doing their own work independently. with the closure of special schools and day care centres these children lack access to resource material, peer group interactions and opportunities of learning and developing important social and behavioural skills in due time may lead to regression to the past behavior as they lose anchor in life, as a result of this their symptoms could relapse (lee, ). these conditions also trigger outburst of temper tantrums, and conflict between parents and adolescents. although prior to the pandemic, these children had been facing difficulties even while attending special schools, but in due course they had learnt to develop a schedule to adhere to for most of the time of the day (apa, ; cortese et al., ; unicef, a). to cater to these challenges, it is difficult for parents to handle the challenged children and adolescents on their own, as they lack professional expertise and they mostly relied on schools and therapists to help them out (dalton et al., ). since every disorder is different, every child has different needs to be met. the children with autism find it very difficult to adapt to the changing environment. they become agitated and exasperated when anything is rearranged or shifted from its existing setup. they might show an increase in their behavioral problems and acts of self-harm. it is a huge challenge for parents to handle autistic children due to lockdown. the suspension of speech therapy and occupational therapy sessions could have a negative impact on their skill development and the achievement of the next milestone, as it is difficult for them to learn through online sessions (unicef, a). the children with attention deficit hyperactivity disorder (adhd), struggle to make meaning of what is going around them from the cues they get from their caregivers. it is difficult for them to remain confined to a place and not to touch things, which might infect them. due to being confined to one place the chances of their hyperactivity increases along with heightened impulses and it becomes difficult for the caregivers to engage these children in meaningful activities (cortese et al., ). obsessive compulsive disorder (ocd) among the children and adolescents is estimated to be of . %- % among children and adolescents (cdc, ). children with ocd are suspected to be one of the most affected ones by this pandemic. due to obsessions and compulsions related to contamination, hoarding, and somatic preoccupation, they are expected to experience heightened distress. cleanliness is one key protective measure against the spread of covid- . according to united nations' policy guidelines to fight the infection one has to be careful about washing their hands six times a day, and whenever they touch anything (apa, ; united nations, ). the lockdown, which has made the healthy population distressed about possessing enough food and prevention related resources like masks and sanitizers, has made it worse for people with hoarding disorder (apa, ; mukherjee et al., ) social inequality has been associated with the risk of developing mental health challenges. the pandemic and lockdown world has experienced global economic turn-down which has directly worsened the pre-existing social inequality. in developing countries, with the in order to cover up the loss of education during lockdown, many schools have offered distance learning or online courses to students. however, this opportunity is not available to underprivileged children as a result of which they face a lack of stimulation and have no access to online resource material to study. a study pointed out that in underprivileged families, in comparison to boys, girls have decreased access to gadgets, this may diminish their involvement in digital platforms of education (mcquillan & neill, ). due to this gender inequality, increasing number of girls are prone to bear the consequences of school dropouts once the lockdown is lifted (cooper, ; pti, ). covid with the objective of universal prevention and mental health promotion, the international it is imperative to plan strategies to enhance children and adolescent's access to mental health services during and after the current crisis. for this direct and digital collaborative network of various stakeholders is required. recommendations for ensuring mental well-being of children and adolescents during the covid- pandemic and lockdown and the role of parents, teachers, pediatricians, community volunteers, the health system and policy makers are being discussed. in addition a brief summary of the roles is given in table . [ table is uploaded seperately] in the times of paramount stress and uncertainty, a secure family environment which the parents can provide is a strong protective factor (schofield et al., ) . there is evidence to . efforts should be made so that a consistent routine is followed by the child, with enough opportunities to play, read, rest and engage in physical activity. it is recommended that family plays board games and engages in indoor sports activities with the child to avoid longer durations of video games. parents should ensure that particularly the bedtime of a child is consistent. it is possible that before the bed time children may need some more time and attention. . focus should be on the 'good behaviour' more than 'bad behaviour' of a child. parents must tell more about options regarding what to do rather than what not to do. provide more praise and social reinforcements to children compared to material reinforcements. . it is quite possible that parents observe some amount of change in the behavior in children during the times of a pandemic. if the behavior problems are minor and not harmful for children and others, parents should consider ignoring and stop paying attention to them, this may lead to decrease in the recurrence in behavior and would also help in giving space to each other. apart from areas discussed above, certain areas which need especial focus in the phase of adolescence, are being described below: . this is an opportunity for older children to learn responsibility, accountability, involvement, and collaboration. by taking some responsibilities at home on an everyday basis, for instance maintenance of their belongings and utility items. they can learn some of the skills including cooking, managing money matters, learning first aid, organizing their room, contributing to managing chores like laundry, cleaning and cooking. . excessive internet use e.g. internet surfing related to covid- should be avoided as it results in anxiety. similarly, excessive and irresponsible use of social media or internet gaming should be cautioned against. negotiations with adolescents to limit their time and internet-based activities are recommended. more non-gadget related in door activities and games are to be encouraged. . in such conditions taking up creative pursuits like art, music, dance and others can help to manage mental health and well-being for everyone. inculcating self-driven reading by making them select books of their choice and discussing about them helps in adolescent development. . adolescence is a phase of enthusiasm and risk-taking, hence some may feel invincible and try not to follow guidelines related to distancing and personal hygiene. this has to be addressed with adolescents assertively. . it is crucial to value the peer support system of the adolescents. parents should encourage adolescents who are introverts to keep in touch with their peers and communicate with them about their feelings and common problems they face. this may also lead a way for appropriate problem-solving. . it is advised to parents to take care of their own mental health needs and try to cope with stress adaptively. in the present times when most schools and colleges are organizing online academic activities, teachers are in regular touch with students, and therefore are in a position to play a critical role in the promotion of psychological well being among youngsters. their role during covid- pandemic and lockdown are as follows: . teachers can devote some time related to educating about covid- and preventive health behavior by using the guidelines of the international organizations, according to the maturity level of the students. they can explain to the students about the need to act with responsibility during the current pandemic. they can model and enact through their behavior the preventive measures. . they can conduct creative online academic and non-academic sessions by making their classes more interactive, engaging students in the form of quizzes, puzzles, small competitions, and giving more creative home assignments to break the monotony of the online classes. standard educational material can be used. for instance, unesco has offered many online educational sources (unesco, ) they can discuss what is wellbeing and how it is important for students. they can assist in teaching simple exercises, including deep breathing, muscle relaxation, distraction, and positive self -talk. virtual workshops can be conducted in which 'life skills' related to coping in stress can be in focus by using more practical examples. . teachers can make children understand the importance of prosocial behavior and the importance of human virtues like empathy and patience among others. this can help them to understand their role in the society and understand how social distancing is not equivalent to emotional distancing. . the teachers need to interact with parents online or through phone regarding feedback about students and their mental health. because of the digital divide they can call parents, make their contact available to parents and devote a time slot when they can be available to parents to communicate. . they can serve as a doorway for identification and referral to specialty mental health providers. they have a role act as a catalyst between the parent based on their interaction with students and findings of screening tools. if they observe any problem in the child, they can talk to parents and refer children and adolescents to mental health professionals. . with the support of school authorities, teachers need to make arrangements to ensure that the reading material related academics and life skills is made available to the underprivileged children who do not have access to the internet. if possible arrangements can be made for them to use internet. during a child's formative years when their personalities are shaped, parents are in regular touch with pediatricians, as parents reach out to their local pediatricians whenever they encounter health/ behavioral complaints associated with their children. parents expect answers from them as they trust them. hence a pediatrician's role is paramount in promoting ptsd, depression, substance abuse in adolescents should also be addressed on similar lines. there is a requirement for creative solutions, often on a case-by-case basis. . psychiatrists need to carefully weigh the risks and benefits of psychotropic medications for children and adolescents e.g. anti-depressants, anxiolytics, anticonvulsants, etc., and if possible, arranging medicines for those who cannot arrange. . there is a need for mental health care workers carry out longitudinal and developmental studies on short term and long term mental health impact of the covid pandemic and lock down on children and adolescents. it has been recognized by the world that the traditional pre-covid- models and policies for children and adolescents' mental health are no longer applicable during covid era. hence, the need is felt for the transformation of policies that can take into account not only lock down duration but also times following the lockdown. the following recommendations may be useful for guiding the functioning of the health system and policy making related to mental health care of children and adolescents : . the focus of the health care system should be prevention, promotion, and treatment according to the public mental health system to meet population-mental health needs of the general population at large. no single umbrella policy would be able to take into account various mental health aspects of children and adolescents dwelling in different environments. hence the health system and policies should be based on contextual parameters that are different for each country or region depending on the degree of infection and the phase of infection they are in. . since there is a dearth of mental health care workers in most developing countries. there is a need for inclusive approaches in which health care workers e.g. pediatricians, general physicians, schools, non-governmental organizations sectors are involved. moreover, brief basic mental health care training for these arms should be planned. . separate rules for the rural, suburban, and concrete domiciles in growing countries spotting the variance among college districts, which includes city, suburban, and rural districts. the studies included in the review were collected after setting criteria to have a comprehensive view of the global vision in managing the crisis of children in the covid- pandemic. the majority of the studies included in the review were based on online selfreports (bhat et al., ; jiao et al., ; oosterhoff et al., b) . the adults and older children were the respondents of the study (lee, ; liu et al., ; viner et al., b; wang et al., (wade et al., ) . the review articles for this review have been selected during the time of global lockdown, where the issues and challenges were new and the global crisis was at peak times. in our review, we were unable to track the measures of management targeted towards the children. the strategies reported in the studies were isolated to geopolitical conditions. the recommendations provided in this review can be modified to suit the needs of the places according to their local resources and geopolitical scenarios. due to strict selection criteria and the short period of data collection and the only use of electronic databases for our research, there is a possibility of missing studies relevant to the care of children and adolescents. although the rate of covid- infection among young children and adolescents is low the children who receive training, therapy, and other treatments are at high risk of being derailed from therapy and special educations. economically underprivileged children are particularly prone to exploitation and abuse. children quarantined are at high risk for developing higher risk for mental health-related challenges. there is a need to ameliorate children and adolescent's access to mental health services by using both face to face as well as digital platforms. for this collaborative network of parents, psychiatrists, psychologists, pediatricians, community volunteers, and ngos are required. there is a need for 'tele mental health compatibility' and be accessible to the public at large. this would be crucial to prevent during and post-pandemic mental challenges in the most vulnerable and underprivileged section of the society. the focal point of the health care system and policymaking should be prevention, promotion, and interventions corresponding to the public mental health system to meet the mental health needs of the population at large by taking the regional contextual parameters into account. disclosure of prior presentation of study data: this paper has not been submitted in full or part in any conference and is not being considered for publication elsewhere. creating material for community volunteers and ngos for identifying high risk children e.g. underprivileged children, children of migrants, provide psychological first aid, coordinating with care givers and mental health care professionals. quarantined parents/children parents if child is separated to keeping contact as much as possible, being supportive and reassuring coordinating with care givers, referring to mental health care professionals foster care givers being supportive, reassuring and educating constructing and administring online questionnaires in order to detect psychological distress and other symptoms for children if they or their parents are quarantined, providing extra support to them and developing ad hoc supportive interventions. impacts of covid- on vulnerable children in temporary accommodation in the uk. the lancet public health closure of universities due to coronavirus disease (covid- ): impact on education and mental health of students and academic staff professional foster carer and committed parent: role conflict and role enrichment at the interface between work and family in long-term foster care diagnosis, treatment, and prevention of novel coronavirus infection in children: experts' consensus statement children's mental health in times of economic recession: replication and extension of the family economic stress model in finland global population of children children with autism and covid- policy brief: the impact of covid- on children school closure and management practices during coronavirus outbreaks including covid- : a rapid systematic review. the lancet child & adolescent health school closure and management practices during coronavirus outbreaks including covid- : a rapid systematic review. the lancet child & adolescent health why we need longitudinal mental health research with children and youth during (and after) the covid- pandemic detection of sars-cov- in different types of clinical specimens healthy parenting who | covid- : resources for adolescents and youth world health organization mental health care for international chinese students affected by the covid- outbreak the authors whose names are listed below certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants, participation in spakers' bureaus arrangements, consultancies, memberships, stock ownerships, or other equity interest, or expert testimony and patent licencing arangements) or non financial interests such as ( personal or professional relationships, affiliations, knowledge or beliefs)in the subject matter or materials discussed in this manuscript. all the authors confirm that, all of them has contributed in the conception of design; analysis, interpretation of data; drafting the article; critically revisiting the article for important intellectual inputs; and approval of the final version. this paper has not been submitted elsewhere or is under review at another journal or publishing venue. the authors have no affiliation with any organization, with a direct or indirect financial interest in the subject matter discussed in the manuscript. authorities to be more transparent in their negotiations and to allow candidates sufficient notice to prepare emotionally as well. students to be timely provided counselling. key: cord- - yvfdqbq authors: chughtai, abrar ahmad; seale, holly; macintyre, chandini raina title: availability, consistency and evidence-base of policies and guidelines on the use of mask and respirator to protect hospital health care workers: a global analysis date: - - journal: bmc res notes doi: . / - - - sha: doc_id: cord_uid: yvfdqbq background: currently there is an ongoing debate and limited evidence on the use of masks and respirators for the prevention of respiratory infections in health care workers (hcws). this study aimed to examine available policies and guidelines around the use of masks and respirators in hcws and to describe areas of consistency between guidelines, as well as gaps in the recommendations, with reference to the who and the cdc guidelines. methods: policies and guidelines related to mask and respirator use for the prevention of influenza, sars and tb were examined. guidelines from the world health organization (who), the center for disease control and prevention (cdc), three high-income countries and six low/middle-income countries were selected. results: uniform recommendations are made by the who and the cdc in regards to protecting hcws against seasonal influenza (a mask for low risk situations and a respirator for high risk situations) and tb (use of a respirator). however, for pandemic influenza and sars, the who recommends mask use in low risk and respirators in high risk situations, whereas, the cdc recommends respirators in both low and high risk situations. amongst the nine countries reviewed, there are variations in the recommendations for all three diseases. while, some countries align with the who recommendations, others align with those made by the cdc. the choice of respirator and the level of filtering ability vary amongst the guidelines and the different diseases. lastly, none of the policies discuss reuse, extended use or the use of cloth masks. conclusion: currently, there are significant variations in the policies and recommendations around mask and respirator use for protection against influenza, sars and tb. these differences may reflect the scarcity of level-one evidence available to inform policy development. the lack of any guidelines on the use of cloth masks, despite widespread use in many low and middle-income countries, remains a policy gap. health organizations and countries should jointly evaluate the available evidence, prioritize research to inform evidence gaps, and develop consistent policy on masks and respirator use in the health care setting. to maintain the functionality and capacity of the healthcare workforce during outbreaks or pandemics of emerging infections, such as influenza, health care workers (hcws) need to be protected. medical masks ("masks") and respirators are commonly used to protect hcws from respiratory infections. in the healthcare setting, masks are used to prevent hcws acquiring respiratory infections, from splashes of blood and body fluids and to reduce transfer of potentially infectious body fluids in the sterile area. alternatively, they may be used by the hcw and coughing patient to prevent the spread of infection in the ward, referred to as "source control" [ ] [ ] [ ] [ ] . masks were not designed to provide respiratory protection [ ] , as they have consistently lower filtration efficiency than respirators [ ] [ ] [ ] [ ] . a respirator is a fitted device that protects the wearer against inhalation of small and large airborne particles, that is, it protects the wearer from others who are or might be infected [ ] . high-income countries have established infection control programs which can be implemented with good resourcing. the guidelines and advice underlying these control programs have been produced by high-income countries for their own social, economic, and health environments. low and middle income countries may not have the ability or finances to adopt generic infection control or pandemic guidelines, equivalent to those originating from high income countries. the practices occurring in low/middle income countries may be driven by a number of factors other than available scientific evidencesuch as available resources, occupational health and safety (ohs) legislation, culture, logistics and cost considerations. whilst much has been written about available policies issued by the world health organization (who), and the united states centers for disease control and prevention (cdc), little is known about the consistency in policies from low and middle income countries, and country-specific issues which can drive different needs. in light of ongoing threats from influenza (h n , h n and h n ) and other emerging infections, it is essential to examine the policies and guidelines of various organizations and countries to examine whether they are evidence based, and whether there are any issues with the recommendations. this study aimed to examine available policies and guidelines around the use of masks and respirator for hcws, for the prevention of influenza, sars and tb; and to describe areas of consistency and inconsistency between guidelines, as well as gaps, with reference to the who and the cdc guidelines. the guidelines of two large public health organizations, three high-income countries and six low/middle income countries were purposely selected for inclusion in this study. we included guidelines from two major health organizations which are commonly used internationally as a reference, namely the world health organization (who) and the us centers for disease control (cdc). guidelines from three high income countries (australia, canada and uk) and six middle/low income countries (bangladesh, china, india, indonesia, pakistan and vietnam) were also selected. the main reasons for purposively selecting these guidelines was that the six low/ middle income countries account for % of the world's population and represent areas where emerging infectious diseases are likely to arise from. most of these guidelines were publically available or were accessed through known key contacts, and were available in a language which could be readily translated in-house. we selected guidelines related to influenza, sars and tb for this review. given that influenza has the potential to cause both seasonal infections and pandemics; it was chosen as the primary infection of interest. tb was selected as an example of a chronic but highly infectious disease. in contrast to influenza, tb has a long incubation and infection period. lastly, sars was selected as an example of emerging infectious disease, which required a rapid response. information relating to mask and respirator use was extrapolated from the following sources: a) general infection control guidelines; b) disease specific infection control guidelines (influenza, sars and tb); c) personal protective equipment guidelines; d) mask/respirator use guidelines and e) position statements. documents published in the last twelve years in any language were screened with key words for applicability. in the event that two versions of the guideline were found, the most recent version was included. four strategies were utilized to locate relevant documents. firstly, websites including the who (plus regional offices), cdc, selected countries health departments and other relevant websites were screened. secondly, a key word search was conducted using google, with results per page set and the first two pages of hits reviewed. the policies and guidelines were also searched in the native languages of the selected countries through advance search settings in google. the search results were narrowed down by selecting region (e.g. india), site or domain (e.g. gov) and file type (e.g. pdf ). google translator was used to screen the documents in the native languages and then the selected documents were translated by native language speaking colleagues. policies and guideline documents were also searched for using medline, embase, national guidelines clearinghouse, and google scholar through key words. lastly, key personal contacts in the selected countries were contacted in regards to the availability of guidelines in the country. most of the contacts are employed in government organizations or health institutions. the predefined criteria were used to screen the guidelines for their eligibility. title and summaries were firstly assessed by aac and then validated by hs and crm. the following information was extracted from each of the selected guidelines; country/organization, department, publication year, language, title and recommendation on mask/respirator use. the terminology used in different countries and guidelines varied, so a classification system was devised (table ) . in most of the guidelines reviewed, the rationale for the recommendations around mask and/or respirator use is not discussed and evidence is rarely provided. the who, the cdc and most of the countries recommend masks and/or respirator on the basis of the mode of transmission of influenza, sars and tb. however, various types of masks and respirators are recommended in the guidelines for low and high risk situations. although most of the guidelines discuss the importance of training and fit testing for respirators use, very few documents provide detail on those procedures. furthermore, most guidelines do not discuss recommendations on how long masks and respirators should be used for and whether reuse is recommended. only a few mentioned that a single mask could be used for hours [ ], hours [ ] , or even for an entire shift [ ] . although cloth masks are also commonly used in resource limited settings, the use and reuse of cloth masks is not discussed in any guideline. a lack of consistency was identified in regards to the nomenclature used in the documents. the who frequently uses the term "medical masks" [ ] , while the cdc uses the term "facemask". various terms were also used in the country specific guidelines reviewed. for example, pakistan uses medical masks, surgical masks is used in the uk, canada, australia and india document, procedure masks also in the canadian document and finally facemasks is the term used in vietnam. the description of low and high risk situations also varied among the general and disease specific infection control guideline (table ) . for seasonal influenza, the who [ ] and the cdc [ ] recommends that masks be used in low risk situations and respirators in high risk situations. the recommendations from the uk [ ] , australia [ ] , india [ ] and pakistan [ ] are aligned with those from the who and the cdc. however canada [ ] and vietnam [ ] have a different policy, which recommends masks in both low and high risk situations for seasonal influenza. regarding the choice of respirator, the who, the cdc and most of the selected countries recommend an n or its equivalent (ffp or p ) respirator for seasonal influenza. the uk, however, recommends fpp respirators. though the who and the cdc have the same policy for seasonal influenza, they differ in their recommendations for pandemic influenza. during an influenza pandemic, the who recommends mask use in low risk situations and respirators in high risk situations [ ] , whereas, the cdc recommends respirators in both situations [ ] . the guidelines of the uk [ ], canada [ ] , australia [ ] , china [ ] , india [ ] and pakistan [ ] are aligned with those of the who (table ). for pandemic influenza, the who recommends a range of respirators (e.g. p , p , ffp , ffp , n , n and n ) and the cdc recommend n or higher respirators. canada and most of the low/middle income countries recommend n or its equivalent respirators. the uk recommends only ffp , while australia recommends p or powered air purifying respirator (papr). the who and the cdc have different policies when coming in contact with a patient with sars. the who recommends masks in low risk situations and respirators in high risk situations [ ] , whereas the cdc recommends that respirators be used in both low and high risk situations [ ] . the uk [ ], canada [ ] , australia [ ] , pakistan [ ] and vietnam [ ] also recommend respirators be used by hcws for protecting themselves from sars. only china has the same policy as the who [ ] ( table ). the cdc and most of the countries prefer n or equivalent respirators in low risk situations in sars, while the uk recommends a ffp . respirators are recommended by the who [ ] and the cdc [ ] for protection against tb for hcws in both low and high risk situations. canada [ ] , australia [ ] and china [ ] have the same policy as previously outlined. in contrast, respirators are recommended only in certain high risk situations in the uk [ ] , india [ ] , pakistan [ ] bangladesh [ ] and vietnam [ ] ( table ). the who and most of the selected countries recommend n or equivalent respirators for hcws during low and high risk exposure to tb bacillus. though the cdc also recommends n respirators in low risk situation, elastomeric respirators or papr are preferred during the high risk procedures ( table ) . the seasonal influenza guidelines of china, indonesia and bangladesh, sars guidelines of india, indonesia and bangladesh and tb guidelines of indonesia could not be located; and pandemic guidelines of indonesia [ ] and bangladesh [ ] and vietnam [ ] did not make clear recommendation on masks and respirator use. almost all guidelines emphasized the importance of hand hygiene and strongly recommended hcws to wash their hands before and after patients' contact to prevent the spread of respiratory infections. the role of other ppes was also discussed in most of the guidelines. the who and the cdc recommended gloves, gown and goggles for seasonal influenza and pandemic influenza in accordance with the standard precaution, i.e. while in contact with infectious material or risk splash on face or body [ , , ] . however in the case of sars and other newly emerging infections, both organizations strongly recommended the use of gloves, gown and goggles in all patient contact [ , ] . considerable variation was observed amongst the policies and guidelines of the selected health organizations and countries in regards to the use of masks and respirators. the who and the cdc have a similar policy for seasonal influenza and tb; however, they have different recommendations when dealing with pandemic influenza and sars. there is also a vast amount of variation between the various country recommendations for the three diseases. we found that influenza related policies of the selected countries were generally in line with the who, while sars related policies were aligned with those from the cdc. the exceptions were the seasonal influenza policies of canada and vietnam and the chinese sars policy. the previous experience of these three countries with sars may be a factor influencing the variation in recommendations. tb related policies of high-income countries are in line with the who and the cdc, however the policies of the low/middle-income countries are not consistent with either organization. various terms were also used in the guidelines reviewed in relation to the products. this indicated that there is no standard terminology or classification for masks. although the general term "respirator" is constantly used in the guidelines, products with various filtration capacities were recommended for the same diseases. this was especially apparent with regards to the selection of respirators for use during high risk procedures. in some cases, a particular type of respirator recommended by one country was actually discouraged by another country. for example, the cdc and australia recommend papr for high risk situations during sars, whereas, canada and uk discourage papr use due to the risk of self-contamination [ , ] . elastomeric respirators or papr were only recommended for use by the cdc and the high income countries. the availability of resources/funding and more stringent ohs regulations in these high-income settings may be factors influencing this trend. aside from the variation in terminology previously described, some low and high risk situations were classified in a different way. for example, the cdc and canada recommend respiratory protection within meters of an influenza case, which is different from the who policy ( meter). osha also recommends a meter distance [ ] . the rationale for meters is not provided in either guideline. similarly, the canadian pandemic plan considers it high risk if patients cough forcefully, and/or if patients do not comply with respiratory hygiene [ ] and the australian pandemic plan defines high risk when an infected patient may not able to use masks [ ] . however, neither plan provides evidence to support these recommendations. the who and all selected countries have the same policy for pandemic influenza, as for seasonal influenza. the who policies are flexible and probably take into account the possibility of resource issues which could occur. in comparison, the cdc policy is different from the who and other countries. due to a lack of preexisting immunity to pandemic influenza strains, and the potential for the occurrence of severe disease and a high mortality, the cdc recommends respirators. the cdc policies are relatively stringent and may be influenced by the occupations health and safety administration (osha) recommendations. in the usa, the osha respiratory protection standard regulates the use of respirators at workplace. under the regulation cfr . , employers are required to provide respirators to the employees for protection from respiratory hazards [ ] . the osha recommends using n or higher respirators for hcws exposed to pandemic influenza [ ] and sars [ ] . as highlighted in the results, the use of mask and respirator is not discussed in pandemic plans of some countries. our findings corroborate with the who which identified during a comparative review of pandemic plans that only / ( %) of the national plans, discuss the role of masks, respirators and other ppes [ ] . masks may be effective during early stages of a pandemic, when the mode of transmission and virulence characteristics are uncertain, and when pharmaceutical measure; such as a vaccine and/or antiviral, may not be available or delayed [ , ] . studies have demonstrated that masks reduce shedding of virus from the wears month and could be as a mean of source control [ ] . therefore, mask use will not only protect hcws but also prevent spread of infections from them to patients and other people surrounding them. uncertainty around the primary mode of transmission of influenza may be another reason contributing to the variations between the recommendations made by each country. currently the relative contribution and significance of the each transmission mode is not known [ ] [ ] [ ] . most of the information regarding the mode of transmission of influenza is based on old experiments, observational studies during the outbreaks or on other in-direct research, for example drug and vaccine trials [ ] . droplet and contact is thought to be the main modes of transmission for seasonal influenza [ , , [ ] [ ] [ ] . droplet transmission is via large particles (typically > um) that do not suspend in the air, while airborne transmission occurs through the dissemination of small virus containing particles (typically < um) or droplet nuclei in the air. however some researchers argue that the evidence regarding droplet and contact being the main modes of transmission is not adequate [ ] and there is more proof available in favor of the transmission of influenza through the aerosol mode [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . given the ongoing debate about the transmission, it is perhaps not surprising that none of the guidelines justify the selection of masks to evidence around influenza transmission. droplet and contact are thought to be primary modes of transmission of sars [ ] , yet the use of respirators is highly recommended by the cdc and most of the countries in both low and high risk situations. in comparison, the who currently recommends masks for low risk situations and respirators for high risk. low levels of evidence may be contributing to this difference. most of the sars guidelines are based on retrospective, observational studies conducted during the - sars outbreak. during that period, the who recommended hcws to use respirator [ ] . however, who updated its policy in and stated, "the current evidence suggests that sars transmission in health care settings occurs mainly by droplet and contact routes. therefore a medical mask is adequate for routine care". the cdc, however, maintains its position and continues to recommend a respirator [ ] . in the cdc guideline, the rationale of the airborne precautions for sars is discussed in detail. respirators are recommended due to the potential for the airborne transmission, frequently performed aerosol generating procedures (agps) and high case fatality among the hcws. unlike the who, the cdc discussed studies which favor airborne transmission of sars [ ] . there was also a lack of evidence based guidelines in regards to the use of masks/respirators when treating tb patients. the who quoted studies on masks and respirator use for tb patients and concluded that there is little evidence on the effectiveness of respirators [ ] . however the guideline states that "the available evidence, although weak and indirect, generally favors respirator use for protecting the wearer from tb". high prevalence of tb in low income countries and increase chances of exposure due to respiratory aerosol in the healthcare facility setting could be an explanation for this recommendation. however, only the recommendations from canada, australia and china are aligned with the who and the cdc. most of the low income countries recommended the use of respirators only when undertaking high risk procedures on patients with tb. interestingly, the selective use of respirators when treating this patient group was also recommended in the uk policy. the uk recommendations have not been amended since , when the british thoracic society (bts) issued guidelines on the control and prevention of tuberculosis in the uk [ ] . regardless of the mode of disease transmission, all guidelines recommended the use of respirators while performing high risk procedures on influenza, sars or tb patients. studies have demonstrated that respiratory aerosols are produced more during agps. for example, the risk of influenza and sars have been shown to increase after tracheal intubation and non-invasive ventilation [ , ] and risk of tb increases after bronchoscopy and sputum induction [ ] . therefore respirators are preferred during high risk procedures, as they filter small particles and designed to provide respiratory protection. breathing air passes through the respirator filter and small respiratory aerosols are captured through diffusion and electrostatic mechanisms [ , ] . training and fit testing are important components of a respiratory protection program and the efficacy of respirator use improves after being fit tested [ , ] . the risk of inhalation of infective particles is reduced if respirators are properly fitted to the face [ ] . although the who and the cdc discusses the role of fit testing in most of their guidelines, very few countries explain the procedure in detail. guidelines from the low and middle income countries largely ignored this issue. many of the guidelines reviewed also did not specify the maximum duration a single mask could be used for, while others varied in the times suggested. advice pertaining to the reuse and extended of a mask/respirator was also not covered in most of the guidelines. even though the use/reuse of cloth masks is common, especially in low resource countries such as, for example in china [ ] and vietnam [ , ] , none of the guidelines reviewed covered the use of these products. currently, there is a lack of data to either support or refute the effectiveness of woven cloth masks in blocking influenza or virus transmission and fluid resistance. regulatory standards require that surgical masks not permit blood or other potentially infectious fluids to pass through to or reach the wearer's skin, mouth or other mucous membranes under normal conditions and for the duration of time that the protective equipment will be used. as it is not clear that cloth masks or improvised masks can meet the standards set by regulatory bodies and without better testing and more research, cloth masks or improvised masks generally have not been recommended as effective respiratory protective devices, or as devices to prevent exposure to splashes [ ] . currently there is no clinical trial data on the efficacy of cloth masks and most of the available studies are in-vitro [ ] [ ] [ ] [ ] [ ] [ ] . available evidence suggest that cloth masks may provide some protection, it is assumed to be considerable less when compared to the use of surgical masks and respirators [ ] . however, it is theorized that some types of cloth fabric may provide better protection [ ] . in a report by the national institute of health's (nih) committee on the development of reusable facemasks for use during an influenza pandemic, the members were hesitant to discourage the use of cloth masks, but suggested caution around their use as they were not likely to be as protective as surgical masks or respirators [ ] . this review has some limitations. firstly, the guidelines from some countries could not be located, while others did not specifically address the use of masks and respirators. secondly, while we tried to search for the most updated version of guidelines; some countries may have updated the documents and not made them publicly available. finally, this study focused on selected high, middle and low income countries, but did not analyze every country. the situation may be different in these countries. for example, france recommends ffp and austria recommends ffp for the hcws in low and high risk situations during pandemics [ ] . these policies are in line with the cdc policy. on the other hand, policies of the european cdc around the use masks and respirators are the same as those of the who [ ] . health care organizations and countries have different policies and guidelines around mask and respirator use for influenza, sars and tb. these policies not only vary regarding the choice of product used but also the application and specifications. these differences may reflect the relative lack of level-one evidence available to inform policy development. for the end user in a healthcare facility setting, the availability of conflicting guidance about mask use from different sources (such as who and in-country guidelines) may be confusing. health organizations and countries should jointly evaluate the available evidence and develop a uniform policy on masks and respirator use in the health care setting. the situation in low income settings should be considered and various options should be explored. there is a need to conduct further studies to generate better evidence to inform policy and current practices. currently there are major gaps around the modes of transmission of respiratory viruses, the efficacy of cloth masks and the impact of extended and re-use of masks/respirators. professor raina macintyre receives funding from influenza vaccine manufacturers gsk and csl biotherapies for investigator-driven research. dr holly seale holds an nhmrc australian based public health training fellowship ( ). payment for presentations: dr seale has received funding from sanofi pasteur, gsk and csl biotherapies for investigator driven research and for conference presentations. authors' contribution aac, hs and crm contributed to the design of the study. aac undertook the search strategy and made the initial selections which were subsequently validated by hs and crm. aac developed the first draft of the manuscript and hs and crm extensively reviewed the paper. all authors read and approved the final manuscript. guideline for isolation precautions: preventing transmission of infectious agents in health care settings department of labor: healthcare workers and healthcare employers preventing transmission of pandemic influenza and other viral respiratory diseases: personal protective equipment for healthcare personnel update australian health management plan for 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workplace performance of n respirators comparison of performance of three different types of respiratory protection devices maskwearing and respiratory infection in healthcare workers in beijing china use of cloth masks amongst healthcare workers in hospitals in hanoi health care worker practices around face mask use in hospitals in hanoi, vietnam. th icid abstracts the aetiology of puerperal infection a study of surgical masks emergency respiratory protection against radiological and biological aerosols method for evaluating effectiveness of surgical masks the efficiency of surgical masks of varying design and composition simple respiratory mask professional and home-made face masks reduce exposure to respiratory infections among the general population simple respiratory protectionevaluation of the filtration performance of cloth masks and common fabric materials against - nm size particles disease control and prevention: interim ecdc public health guidance on case and contact management for the new influenza a (h n ) virus infection availability, consistency and evidence-base of policies and guidelines on the use of mask and respirator to protect hospital health care workers: a global analysis we acknowledge the support we received from the focal points and key informants in the selected countries. we also wish to thank our unsw colleagues for translating the policies and guidelines from other languages. key: cord- -plcdwazu authors: gore, dana; kothari, anita title: social determinants of health in canada: are healthy living initiatives there yet? a policy analysis date: - - journal: int j equity health doi: . / - - - sha: doc_id: cord_uid: plcdwazu introduction: preventative strategies that focus on addressing the social determinants of health to improve healthy eating and physical activity have become an important strategy in british columbia and ontario for combating chronic diseases. what has not yet been examined is the extent to which healthy living initiatives implemented under these new policy frameworks successfully engage with and change the social determinants of health. methods: initiatives active between january , and september , were found using provincial policy documents, web searches, health organization and government websites, and databases of initiatives that attempted to influence to nutrition and physical activity in order to prevent chronic diseases or improve overall health. initiatives were reviewed, analyzed and grouped using the descriptive codes: lifestyle-based, environment-based or structure-based. initiatives were also classified according to the mechanism by which they were administered: as direct programs (e.g. directly delivered), blueprints (or frameworks to tailor developed programs), and building blocks (resources to develop programs). results: initiatives were identified in ontario and were identified in british columbia. in british columbia, . % of initiatives were structure-based. in ontario, of provincial initiatives identified, % were structure-based. ontario had a higher proportion of direct interventions than british columbia for all intervention types. however, in both provinces, as the intervention became more upstream and attempted to target the social determinants of health more directly, the level of direct support for the intervention lessened. conclusions: the paucity of initiatives in british columbia and ontario that address healthy eating and active living through action on the social determinants of health is problematic. in the context of canada's increasingly neoliberal political and economic policy, the public health sector may face significant barriers to addressing upstream determinants in a meaningful way. if public health cannot directly affect broader societal conditions, interventions should be focused around advocacy and education about the social determinants of health. it is necessary that health be seen for what it is: a political matter. as such, the health sector needs to take a more political approach in finding solutions for health inequities. preventative strategies focusing on healthy eating and physical activity, collectively known as healthy living, have become an important strategy in canada for combating chronic diseases. chronic diseases are rising to epidemic proportions in the canadian population and costs associated with treating them pose a serious threat to the sustainability of the health care system [ ] . addressing the underlying causes of chronic diseases and their inequitable distribution through a preventative health promotion strategy has been acknowledged as an effective way to reverse these trends in both ontario (on) and british columbia (bc). these provinces have recently reformulated their chronic disease prevention strategies as part of canada's renewal of public health systems, initiated in as a response to severe acute respiratory syndrome (sars). a common strategy that both provinces pursue is to address chronic disease prevention through healthy living initiatives -initiatives that work to promote healthy eating and physical activity as well as address other risk factors such as unhealthy alcohol consumption and tobacco use. while healthy eating and physical activity were traditionally considered individual lifestyle choices, public health has shifted its perspective in the past several decades to encompass the broader context in which these choices are made. this includes daily living and working conditions that are not conducive to healthy lifestyles as well as broader structural determinants that create inequities between population groups, which together form the social determinants of health [ ] . the world health organization (who) has defined the social determinants of health in the following way: "the poor health of the poor, the social gradient in health within countries, and the marked health inequities between countries are caused by the unequal distribution of power, income, goods, and services, globally and nationally, the consequent unfairness in the immediate, visible circumstances of peoples livestheir access to health care, schools, and education, their conditions of work and leisure, their homes, communities, towns, or citiesand their chances of leading a flourishing life. together, the structural determinants and conditions of daily life constitute the social determinants of health and are responsible for a major part of health inequities between and within countries" [ , p. ] . within a canadian context, some examples of social determinants of health that have been identified are: income and income distribution, education, unemployment and job security, employment and working conditions, early childhood development, food insecurity, housing, social exclusion, social safety net, health services, aboriginal status, gender, race and disability [ ] . the social determinants of health have been consistently linked in the literature to chronic diseases such as cardiovascular disease, respiratory diseases, diabetes and cancer in canada and worldwide; for example, it has been found that low socioeconomic status (ses), often measured by income and education levels, is associated with higher rates of cardiovascular disease, chronic obstructive pulmonary diseases, diabetes mellitus and asthma [ ] [ ] [ ] [ ] [ ] [ ] . research on canadian cities has shown that people living in low income neighbourhoods experience significantly higher rates of chronic diseases such as diabetes and die several years earlier than their wealthier counterparts [ ] . job insecurity, characterized by unemployment, part-time employment and temporary employment, has been found to result in elevated blood pressure and higher risk of death from cardiovascular disease [ , ] . even in a financially secure job, poor working conditions that place high demands on the worker, combined with low support and low job control have been correlated with elevated stress and increased rates of coronary heart diseases as well as higher risk of cardiovascular-specific mortality [ ] [ ] [ ] . nor are these trends colour-blind; racialized groups such as aboriginal people, new immigrants and minorities of colour consistently earn lower incomes and experience higher rates of chronic disease than north americans of european descent [ ] [ ] [ ] [ ] . canadian policy documents outlining priorities for public health have stressed the importance of an approach that addresses the social determinants of health [ ] [ ] [ ] . in a recent high-level united nations meeting on chronic diseases, the role that the social determinants of health play in chronic disease was recognized, as was the importance of addressing them in disease prevention strategies [ ] . a delegation from canada participated in this meeting, and canada endorsed the resulting declaration [ ] . an approach that effectively engages with the determinants has been suggested in mikkonen and raphael's the social determinants of health: the canadian facts, and includes policies that offer a higher minimum wage, higher assistance levels for those unable to work, a more progressive taxation structure that redistributes income more fairly, increased unionization, better funding of public education, government regulation of post-secondary institution tuition, stronger legislation on anti-discrimination policies and equal opportunity hiring, a national childcare strategy, strategies to increase the affordability of nutritious food, increased spending on a housing strategy, policies that reduce barriers for refugees and immigrants to practice their professions, and recognizing aboriginal government authority over a wider range of aboriginal affairs [ ] . provincial health policy on chronic disease prevention for bc and on corresponds to federal priorities. on has stated in policy documents that the causes of chronic diseases are complex and rooted in broad determinants of health, which encompass lifestyle, socioeconomic, cultural and environmental factors [ , ] . in order to tackle these upstream causes, the province has decided on a comprehensive, integrated population health approach that is evidence-based [ , ] . for example, in a policy document on combating obesity, on committed to a population health approach, which explores health disparities and interactions among the social determinants of health in order to improve the well-being of populations [ ] . this approach can also be seen in the ontario action plan for healthy eating and active living [ ] . on has made efforts to integrate a social determinants of health perspective into the province's public health practice through data and information use guidelines for boards of health of public health units. in the healthy eating, physical activity and healthy weights guidance document, the board of health is instructed to use information on health inequities and the social determinants in order to assess population needs and identify groups at highest risk [ ] . bc shares fundamental similarities with on in its agreement on the importance of the social determinants of health and the need for an evidence-based, population health approach to chronic disease prevention. in the model core program paper on chronic disease prevention in bc, the paper's working group identified key principles for successful disease prevention, which includes a focus on social, environmental and economic determinants of health, a "whole of society" approach to population health, and an equity lens to examine health disparities between different groups [ , p. iv] . the determinants of health are understood to interact with each other in a variety of ways, to compound vulnerabilities for certain sections of the population, and to be modifiable through health public policy and changing social norms. like on, bc also takes health disparities between different parts of the population into account, such as between men and women, different ethnic groups, those who identify as aboriginal, or between people of varying socioeconomic status [ ] . in order to effectively address the social determinants of health, on and bc have committed to multi-sectoral action that targets the population on a variety of levels. both bc and on have stressed the importance of partnerships in the public health model to achieve prevention goals with other levels and sectors of government, ngos, private industry, service providers, researchers, and communities to name a few [ , , [ ] [ ] [ ] . these partnerships are considered crucial for real change, given the upstream, wide-ranging impact of the social determinants of health. both provinces advocate for comprehensive strategies that target the population in diverse environments and at multiple levels [ , ] . these strategies suggest a socio-ecological approach to healthy eating and active living, a model of health that recognizes the interaction between individuals and their greater environment and its impact on health. in a socio-ecological model, the health behaviours that individuals engage in are impacted by individual factors (such as knowledge, lifestyle choices, and attitudes towards health behaviours), as well as interpersonal, community, organizational and society-level factors [ , ] . interventions that follow this model aim to target the population at all these levels and address downstream as well as upstream barriers to healthy living [ ] . it is important to note that although the socio-ecological model is different from the social determinants of health approach, it does not preclude attention to the social determinants of health. the social determinants of health can in theory be addressed at multiple levels within the socio-ecological framework, especially those that are more upstream such as at the societal level. based on the priorities that are listed above for healthy eating and active living in on and bc, it would be expected that initiatives in both provinces target the population in diverse settings and at multiple levels, with a majority of initiatives focusing on improving population health through a social determinants of health framework. however, what has not yet been examined is the extent to which healthy living initiatives implemented under these new policy frameworks successfully engage with and change the social determinants of health. this study seeks to evaluate healthy living initiatives in bc and on that focus on healthy eating and physical activity based on their approach to the social determinants of health and health inequities. the authors draw on a political economy of health perspective in order to evaluate the initiatives within their broader social, political and economic context [ ] . this implies that the findings related to the data are discussed in relation to the larger discourse around the socioeconomic environment and acknowledge the effect of structures and processes external to the health sector. recommendations that emerge from the discussion are approached in a similar way. publically-available provincial policy documents written between and in bc and on that focused on chronic disease prevention were used as a starting point to identify relevant initiatives. the focus was on chronic diseases that are most affected by nutrition and physical activity -namely cardiovascular diseases, some cancers, diabetes, hypertension, stroke and chronic respiratory disease. once initiatives were identified, a web-based search was conducted to obtain a detailed description of the program as well as its timeline and current status (in-planning, ongoing, discontinued) etc. provincial organizations that had the potential to conduct initiatives were also researched online to find initiatives that may not have been mentioned in the original policy documents and database. the search was not restricted to initiatives led by provincial ministries related to health; they could be initiatives of other ministries, arms-length government agencies or independent nonprofit organizations that worked to improve healthy eating and physical activity. in order to ensure the list of healthy living initiatives was comprehensive, it was compared against recent documents and public databases that provide listings of healthy living initiatives at municipal, regional and provincial levels in bc and on [ , , ] . lastly, two policy-makers in bc and on reviewed the list of initiatives to fill any gaps. a) initiatives focused on healthy eating and physical activity as a preventative strategy to reduce chronic diseases or improve general health. the initiatives were not limited to government interventions -the initiatives could be funded and developed by various organizations including actors in the government, non-profit and private sectors. b) initiatives were implemented in bc and on between january , and september , . c) initiatives were provincial rather than regionally or nationally-based. initiatives that focused on select sites in the province were also permitted provided they weren't restricted to a particular region or area. for example, an intervention targeting remote communities in on would be acceptable for analysis, whereas an intervention led by a particular health authority and applied only to that health authority's region would not be included. the findings are limited to the provincial scope of initiatives selected. it is difficult to determine if analysis of regional, municipal or community level initiatives would reveal convergent findings, and represents an area for future study. each of the identified initiatives was reviewed, analyzed and grouped using descriptive labels. codes were developed directly from the data by asking the following questions of each initiative: a) what section of the population does the initiative target? (ex. general public, vulnerable populations, health service providers, community actors, etc.) b) what factor is the initiative trying to change that will lead to healthy eating and active living? (e.g. knowledge, skills, attitudes, built environment, access, social/economic/political factors, etc.) c) does the initiative directly acknowledge and attempt to act on the social determinants of health? if so, in what way? (e.g. education, advocacy, public policy change, etc.) d) what is the mechanism that the initiative uses to promote healthy living? (e.g. direct program for population, resources, toolkits, consultation services, grants, etc.) the predominant themes that emerged from questions b. and c. reflected three types of initiatives: lifestylebased, environment-based, and structure-based, which were defined for this paper in the following ways: lifestyle-based: these initiatives aim to improve healthy living through lifestyle change of individuals. examples include raising awareness of the issues (e.g. obesity) in the general population, increasing knowledge around nutrition and physical activity, changing attitudes towards healthy living by appealing to social norms (e.g. social marketing campaigns) or directly encouraging the adoption of new behaviours through programs (ex. eating foods with lower salt content, exercising for minutes each day). the target audience could be the general public or specific groups (e.g. low income individuals, children, or aboriginal people) environment-based: these initiatives are meant to improve healthy living by influencing the immediate environment in which people spend their time, such as schools, workplaces and community spaces. examples of these initiatives range from encouraging employers to initiate healthy workplace programs to banning the sale of unhealthy foods in schools or working towards a built environment that encourages physical activity. these initiatives were frequently settings-based and address the role that immediate environmental factors play in health. structure-based: these initiatives directly acknowledge the impact of various structures (e.g. social, political, economic) that create inequities leading to chronic diseases and attempt to address the social determinants of health directly in order to improve healthy eating and active living. these types of interventions are most frequently centered around education and advocacy on the social determinants of health and worked specifically to correct health inequities caused by these structural conditions. examples include a survey tool that assesses the cost of basic healthy eating in different geographic areas in order to monitor accessibility and affordability of a nutritious diet, the creation of community forums to discuss the social determinants of health and explore structural barriers to healthy living, or consultation services that provide gender equity audits to sport and recreation organizations. of the three categories, this one is the only one that directly acts on the social determinants of health. for each initiative type, it was also found using questions a. and d. that there was a broad variety of mechanisms by which the initiative was supported and delivered. consequently, in each category, initiatives were classified according to the mechanism by which they were administered. mechanisms were categorized as direct programs, blueprints, and building blocks, and were defined as the following: direct program: initiatives that are developed and implemented to directly influence the health of the population. initiatives could be implemented through organization staff, contracting of other staff, working with community partners, or enforcing mandatory policy. examples include direct services from health professionals such as phone lines staffed by dieticians and specialists in physical activity, bills to prohibit certain foods, and programs that provide healthy snacks to schoolchildren. this category also applies to programs that reward organizations (communities, schools) for programs they have already implemented. blueprint: initiatives that are developed but require implementation and tailoring by a third party such as a school, public health unit, or community organization. these initiatives are categorized as blueprints because while they offer a "plan" for a healthy eating and active living intervention (heal), they do not directly act on the population and their implementation is optional. examples include toolkits for healthy school policies, materials for teachers to encourage student physical activity, and frameworks for how to build healthy communities. these initiatives require more action at the local level than direct programs because although the initiative is planned, local actors are needed to carry it through. building blocks: initiatives that are meant to act as resources for third parties to develop their own projects, within certain guidelines. examples include grants for communities to build their own heal project, consultation and training services on program planning, and directories of heal initiatives to act as a resource for ideas in developing an initiative. these initiatives require the most action at the local level; their planning and implementation fall to local actors and they provide the least support from the organization that is offering the initiative. from the systematic scan of the policy documents, database and website search, initiatives were identified in on and were identified in bc. (please see additional file and additional file for a full list of initiatives). programs were headed by various actors in both provinces, including ministries of health, other government sectors such as the ministry of education, non profit organizations, and professional associations. often initiatives were structured as a partnership among multiple actors across different sectors. while many different organizations led and implemented healthy living initiatives, the majority were linked to provincial government in some way -either through direct funding, funding through an arms-length government agency (e.g. cancer care ontario or public health ontario), funding through a non-profit organization that has received sizeable grants for healthy living initiatives (e.g. bc healthy living alliance), or partnership with a government agency. government involvement in on programming or financing included the province of ontario, the ministry of health and long-term care, the ministry of child and youth services, the ministry of community and social services, the ministry of education, the (former) ministry of health promotion and sport, and the ministry of agriculture, food and rural affairs. government involvement in bc programming or financing included all ministries, since all participated in act-now bc. some key ministries involved in healthy living initiatives were the ministry of health, the ministry of community, sport and cultural development, the ministry of education, the ministry of agriculture and lands, the ministry of children and family development, and the ministry of transportation and infrastructure. many initiatives involved multiple ministries and most included a health-related ministry. in on, of the initiatives were not linked to the provincial government, and were organized and/or financed by parks and recreation ontario, the ontario heart and stroke foundation, dairy farmers of canada, and a partnership between the university of guelph and the city of guelph. in bc, of the initiatives were not linked to government, and were organized and/or financed by the bc parks and recreation association, the heart and stroke foundation of bc & yukon, the bc dairy foundation, the greater vancouver food bank and breakfast for learning bc. for examples of initiatives classified into the three intervention types, please see table . for examples of initiatives classified into the three delivery types, please see table . in bc, interventions were lifestyle-based, were environment-based and seven were structure-based. nine interventions had multiple components that targeted a combination of lifestyle, environmental and structural factors, and so were classified into more than one category. in terms of method of delivery, direct interventions were more prevalent in lifestyle-based initiatives: initiatives used direct programming while initiatives were blueprints and were building blocks. in the environment-based category, there was more of a balance between mechanisms of delivery: a roughly equal number of environment-based initiatives worked through direct, blueprint and building block mechanisms ( , eight and nine, respectively). structure-based interventions were those that received the least direct support: only one was enacted through direct programming, one used the blueprint format, and six were building blocks-type initiatives. on yielded similar results in terms of distributionthe preponderance of initiatives were lifestyle-based, followed by environment-based, with very few aimed at structural change. of provincial initiatives identified, were lifestyle-based, were environment-based and nine were structure-based. six interventions had multiple components that targeted a combination of lifestyle, environmental and structural factors, and so were classified into more than one category. most lifestylebased interventions were direct ( ), while were blueprint initiatives and four were building blocks. environment-based initiatives were also more likely to a six week cooking program that is administered to 'at-risk' target populations. the program is administered by community facilitators, who have been trained by the bchla (the organization that offers this initiative). offers ontarians free dietitian services on healthy eating and nutrition through a website, email, and toll-free number. a set of written resources with activity ideas to help parents, caregivers and early learning practitioners encourage healthy eating and physical activity in young children. a set of programs, written resources and workshops to help early childhood, elementary, and middle school teachers teach their students about nutrition and healthy eating. a program offering grants for start-up of community and school-based snack programs directed at children and youth and bc that include an educational component. an organization that provides services to community organizations that aim to develop health promotion programs. services include consultations, workshops and resources related to program planning, implementation, and evaluation. a free telephone resource for british columbians to receive information and advice from exercise physiologists on physical activity and healthy living. screening of children up to the age of as well as parenting support, referrals and information on healthy practices such as breastfeeding, infant care and infant nutrition. farm to school salad bar bill : healthy food for healthy schools act a program that connects schools with local farms in order to increase students' access to healthier food (e.g. fresh produce). an amendment to on's education act limiting the amount of transfats that can be sold on school property through means such as vending machines, special events and cafeterias. a grants program for communities to begin a dialogue on how to address barriers to physical activity. it also provides resources on how social determinants of health such as poverty and social exclusion affect access to physical activity. a survey tool that municipal boards of health are required to use in order to calculate the cost of nutritious food. this can be used to monitor how affordable and accessible foods are by comparing them to income levels of on households be direct ( ) while nine were blueprints and four were building blocks. of initiatives that acted at a structural level, two acted through direct mechanisms, three were blueprints and four were building blocks. in summary, bc and on had similar distributions of intervention types, with the majority falling into lifestyle-based initiatives, followed by environment-based initiatives, and a small proportion falling into the structure-based category. while many initiatives focused on changing lifestyle and the immediate environment to improve healthy eating and physical activity, very few were directed towards changing more upstream social determinants of health, such as the economic and social conditions that create inequities between genders, income groups and ethnic groups. only . % of initiatives in bc and . % of initiatives in on had structural components that directly spoke to the social determinants of health. in terms of the mechanism by which the intervention was implemented, on had a higher proportion of direct interventions than bc for all intervention types ( . % vs. . % for lifestyle-based interventions, . % vs. . % for environment-based interventions, and . % vs. . % for structure-based interventions). however, the same trend can be observed for both provinces: as the intervention becomes more upstream and attempts to target the social determinants of health more directly, the level of direct support for the intervention lessens. in bc direct programming drops from . % for lifestyle-based initiatives to . % for environment-based initiatives to % for structure-based initiatives. in on direct programming drops from . % for lifestyle-based initiatives to . % for environment-based initiatives to . % for structure-based initiatives. for a visual representation of this trend, please see figure . the dominance of lifestyle-based and environmentbased initiatives is troubling considering that initiatives were expected (and directed) to focus on the social determinants of health. although individual behaviour change theories were popular early in the health promotion movement, the field of public health has matured to embrace a more multi-level approach. this change of focus was in recognition of the fact that individual behaviour change strategies are not enough for lasting health improvements, given structural conditions which predispose people to illness [ ] [ ] [ ] . they may actually be counterproductive; they tend to place responsibility to change directly on individuals and can lead to victimblaming should barriers prove too great for them to be successful [ ] [ ] [ ] . the individual change strategy can be particularly problematic when it comes to addressing the impact of inequities on vulnerable populations, considering that such interventions often focus on increasing knowledge, changing attitudes and/or encouraging adoption of healthy behaviours. this approach in a marginalized group runs the risk of implying that the group is to blame for their higher rates of chronic disease, purportedly due to their own ignorance of healthy living or lifestyle choices. environment-based interventions, while more sensitive to the context in which people live and work, still do not tackle the structural determinants which create these conditions in the first place. programs aiming to increase access to nutritious food and physical activity in particular settings such as schools, workplaces, government buildings and communities do not alter the factors which create inequities and unfavourable living conditions [ ] . environment-based initiatives can also have potentially negative implications for health equity when applied at a population level with no consideration for differential access. programs that "treat everyone the same" and fail to acknowledge different positions vis-àvis the social determinants of health may in fact benefit those who already have access while excluding those who are more vulnerable. this effect was succinctly illustrated in frohlich and potvin's critique of geoffrey rose's population strategy [ ] . what is needed are structural interventions that are inherently redistributive in nature; interventions that broaden the distribution of power, income, goods and services across the population. research has demonstrated limited effectiveness of downstream interventions (such as programs that focus on behaviour change) when structural barriers are not addressed [ ] [ ] [ ] [ ] . this is not surprising, considering that structural determinants have been found to influence the distribution of risk factors for chronic diseases such as smoking behaviour, overweight and obesity, and physical inactivity [ , , ] . therefore, attempting to prevent chronic disease by targeting risk factors at the individual or environmental level may not be effective without also addressing the broader determinants that shape those risk factors. as can be seen from the paucity of structural interventions, this approach to healthy living is lacking in on and bc despite provincial policy direction. another discouraging trend found in the data is the decrease in direct initiatives (direct programs) and increase in more indirect ones (at the blueprint and building blocks levels) as the initiatives become more upstream. the amount of indirect initiatives could be interpreted as a move towards increasing community capacity, inclusion, local responsiveness and decision-making in healthy living initiatives. however, the more upstream and broadscale an intervention is (i.e. an environment or structure-based program), the more it would benefit from coordinated action at a higher, more structural level [ ] . initiatives that address the social determinants of health in order to impact the population at a broad level can extend beyond the scope of a particular community organization, whose on-going population reach and resource availability are limited. health equity interventions can also require more direct action from government -for example, an initiative that would help to balance the distribution of wealth in canada is a more progressive taxation structure or an increase in minimum wage to account for inflation and provide a higher standard of living. these are initiatives which cannot be undertaken by individuals and communities. as the word 'structural' implies, they need to be acting directly on the structures (economic, social, political, etc.) which create and maintain health inequities. instead, communities that do not have that capacity are more likely to receive this responsibility -in the form of grants, training workshops for program planning, or mechanisms of initiative implemented included direct programs, blueprints, and building blocks and were calculated for a total of initiatives in bc and in ontario. please note that percentages may not add to % because some initiatives operated by more than one mechanism and so were placed in multiple categories. resource directories. these initiatives are framed as supporting communities in building their own initiative that addresses the social determinants of health. however, the pressure that it places on communities is enormous, and allows the public health system to abdicate its responsibility to address the social determinants of health directly and in a concrete manner. instead it can point to these initiatives and claim that they are focussing on the social determinants of health -this is essentially the provinces of on and bc "passing the buck". given the fact that policy documents on chronic disease prevention and healthy living at the provincial level in both bc and on acknowledge the importance of the social determinants of health, why is the health sector not acting on them? an explanation can be found in the context of canada's political and economic policy over the past several decades. a neoliberal approach to the economy that favours freedom of the market has resulted in the retraction of government intervention in the areas that are crucial to the health and well-being of canadians. research has found that canadians are experiencing increasing levels of poverty and income inequality, as absolute levels of poverty increase and the gap between the poorest % and richest % widens [ ] . research based in toronto has demonstrated this trend of polarization starting from the s [ ] . urban poverty is also becoming more concentrated in peripheral areas -areas that have the highest rates of new immigrants and visible minorities. not surprisingly, child poverty in canada has also deepened in the s [ ] . other determinants of health have also been affected by government policy. the public education system has suffered cutbacks and labour conflicts that reduce its ability to provide quality education [ ] . stricter immigration policy that went into effect as of december will increase social exclusion of immigrants and refugees, while cutbacks to legal aid aggravate the situation [ ] . job insecurity is rising, with the percentage of people in full-time jobs decreasing and the number of people working part-time, in shift work, temporary contracts or self employed increasing [ ] . unionization rates have also dropped across the country [ ] . disproportionate spending on necessities such as housing comes hand in hand with increasing poverty and job insecurity. canada is experiencing a national housing and homelessness crisis. as of , over % of people renting in major urban areas such as toronto, montreal and vancouver were spending more than % of their income on housing (the cut-off for affordable housing). around % are spending more than % of their income on rent, which puts them at risk of homelessness [ ] . when such a high amount of income is being devoted to shelter, not enough is left over for nutritious food, leading to food insecurity [ ] . the effects are felt as a result of inadequate policy and public expenditures on social programs, which are key characteristics of the neoliberal model. public spending on family-related benefits has been scaled back since the s, and taxation policy between and has increased the tax burden on the bottom % of income earners and relieved it from the top % [ ] . minimum wage, although it has increased in absolute terms, has fallen behind the inflation rate and made living above the poverty line more difficult to achieve. the fall of unionization in bc and on can be attributed to policies put into place by conservative governments that made unionization more difficult [ ] . with respect to housing policy, it has been argued that a budgetary increase of % in canadian government spending at the federal, provincial, territorial and municipal levels has the potential to end the homelessness crisis, but they have demonstrated their unwillingness to make that commitment [ ] . within the context of a national and provincial neoliberal climate, it is not surprising that the health sectors of bc and on have not attempted to implement widespread structural change to improve healthy living [ ] [ ] [ ] . even though well aware of the necessity to address the social determinants of health, they may feel powerless to do so in the face of conservative policies initiated by other sectors. as alvaro et al. emphasized using a critical theory lens, government departments linked to economics and ensuring the dominance of the free market have more power than departments such as the ministry of health in a neoliberal model [ ] . those in the health sector face barriers to encouraging other sectors to effect policy change to improve the social determinants of health, and may resort to individual or intermediate behaviour change because they are able to effect that change either through their own department or allied with other de-prioritized departments such as the ministry of education or the ministry of environment. for example, partnering with schools to increase the amount of healthy foods sold in vending machines may be significantly easier than convincing the department of finance to raise the province's minimum wage. we would argue that the ultimate goal of healthy living programs should be to improve the social determinants of health and eliminate health inequities. it is recognized that it is out of the scope of the health care sector to effect those changes on its own, and it faces barriers in partnering with sectors for collaborative, cross-sectoral action. however, public health should be constantly attempting to move towards those goals. it should not settle for programs that bring about changes in lifestyle and the immediate environment while only addressing the social determinants model at a conceptual level. if programs cannot directly affect lasting, broader societal conditions, interventions should be focused around advocacy and education about the social determinants of health -advocacy at the level of the population, service providers, health organizations, and government in order to build political will to address them. the structural interventions listed in additional file and additional file are already taking the initiative to do this and more should be added. one barrier for public health professionals to address the social determinants of health is a lack of understanding of how to do so; although there is a wealth of theoretical understanding of how these determinants affect health, there have been few examples to date that illustrate how to effectively change them [ , ] . in an environmental scan of the integration of the social determinants of health with public health practice, the national collaborating centre for determinants of health noted that implementation of programs that dealt with the social determinants of health in canada was relatively scarce and, when extant, in early phases [ ] . some of the barriers noted to mounting programs that focused on social determinants included gaps in the existing evidence base on the social determinants of health and on interventions that were effective in addressing them, difficulties public health professionals faced in conceptually differentiating individual-level and population-level approaches, a lack of clarity on where in the path from determinants to outcomes public health is expected to act, and limitations in current public health practice methods, which rely mostly on quantitative data. even in a conservative political climate, it is clear that there are improvements that can be made within public health to foster a greater understanding of how to focus programming on the social determinants of health. the who commission on the social determinants of health notes that a comprehensive health equity surveillance system would capture the most upstream structural drivers of health inequities (the unequal distribution of power, money, goods and services) as well as more intermediate ones that encompass the daily conditions in which people live and work. such a system could monitor health equity by stratifying morbidity and mortality data by indicators such as income, occupation, gender, region, ethnicity and immigration status [ ] . some such initiatives already exist, for example the eu health monitoring programme, which could be used as a model for canada [ ] . solid data on health inequities and the social determinants of health serve a dual purpose: not only do they allow public health professionals and provincial health care systems to understand inequities and design effective initiatives that address structural determinants, they can also be used as tools to advocate for change at a broader level, which may be outside the scope of the public health system. for example, data on the health effects of social exclusion faced by new immigrants and refugees could be used to advocate for progressive immigration policies. it is equally important that health organizations and professionals know how to use evidence on inequities and the social determinants of health to create meaningful initiatives. to do this, there must be a comprehensive understanding among the healthcare force of the social determinants of health and how they affect populations. this includes awareness of the social, political and historical context of how these inequities are generated and continue to be maintained. the provincial health services authority in bc has a program modeling this principle called the indigenous cultural competency online training program [ ] . this program consists of a series of online modules and discussions designed to educate health professionals across the province on the context surrounding aboriginal health issues, including the history of colonization in bc, indian residential schools and hospitals, structural and interpersonal racism, and their impacts on aboriginal peoples and their health. it would be extremely useful to have such programs implemented in all provinces, ideally with specific sections that focus on chronic disease, as rates of chronic diseases such as diabetes and cardiovascular disease are much higher in aboriginal populations. with solid evidence and a comprehensive understanding of inequities, there are many ways that public health can begin to address the social determinants of health in programming. one possibility is using public health planning models that integrate the social determinants of health into the planning process. the region of waterloo public health in on developed a planning model that does this, based on the ontario public health standards (ophs) [ ] . the model is called evidence and practice-based planning framework: with a focus on health inequities. in the first two steps of program planning ( . define issue, . situational assessment), planners are encouraged to consider the following: community health needs, the ophs mandate on the social determinants of health, and the association between health status and the determinants of health. further, they are asked to engage stakeholder perspectives [ ] . another model developed by the national public health partnership in australia makes the determinants of health even more central to the planning process [ ] . this framework bases the intervention on the determinant that is causing the health problem, rather than the health problem itself. public health teams are to identify the determinants of the health problem and their context, assess how determinants may be detrimental or protective, appraise different intervention options, decide on an option -taking into consideration its impact on health equity, then implement and review it [ ] . when consistently implemented province-wide these types of planning models will help public health teams incorporate the equity and the social determinants of health into practice in a systematic manner. information and programs generated within the public health sector can be used to advocate for structural change to improve healthy living. an exemplary initiative in ontario is the nutritious food basket, described in table . the nutritious food basket is a program mandated by ontario public health standards (ophs) for boards of health to implement in municipalities across the province. boards of health are required to survey local supermarkets and grocery stores in order to calculate the cost of basic healthy eating for individuals and families. this program is ideal for a number of reasons. it links what is normally considered a behaviour (healthy eating) to greater structural determinants such as income and regional differences in food accessibility. because the survey is taken annually, it can keep pace with larger economic trends such as inflation and food cost patterns, and because it is performed systematically using a detailed protocol it presents reliable data. the data, as mentioned in the nutritious food basket protocol, can be used for program planning, policy decisions, and advocating for accessible, affordable foods. the nutritious food basket can be used as powerful evidence for the necessity of income redistribution policies ensuring that families make enough money to maintain a healthy diet [ ] . certain boards of health, for example in the cities of hamilton and sudbury, have used this tool for this purpose [ ] [ ] [ ] . a current leader in championing health inequities is the sudbury & district health unit, whose team has launched public awareness campaigns linking the social determinants to health outcomes, created health planning and mapping tools that focus on equity, established in conjunction with the city of sudbury a food charter that recognizes food as a basic human right, and developed a primer for municipal leaders explaining the connections of social determinants to public health and how they could address them effectively [ ] . although individual public health units are to be commended for their leadership, coordinated action at the provincial level would be much more influential. external evidence from other countries can also be used as leverage -for example healthy living and chronic disease policy in northern european countries such as sweden and norway. sweden initiated a public health policy in which stressed improving employment conditions and decreasing poverty as primary goals for improving health [ ] . sweden has significantly lower obesity rates than canada and research has shown obesity trends levelling off between / and / [ ] . elizabeth fosse has pointed out that norway focuses on structural measures that function to redistribute resources within society, which is characteristic of a social democratic welfare state [ ] . in a health policy document, the norwegian government outlined a number of strategies to combat health inequities, including reducing inequalities that contribute to poor health [ ] . the government pledged to work to provide safe childhood conditions, fair income distribution, and equal opportunities in work and education. it was also recognized by the norwegian government that individual behavioural choices which impact healthy living are influenced by broader structural determinants, and therefore the government must work to address those determinants by influencing cost and availability of resources to healthy living [ ] . lastly, a strategy employed to reduce inequities was to develop all initiatives to maximize social inclusion of all citizens. these types of policies could be used as models for health inequity reduction strategies advocated by the health sector in bc and on. this study is not without limitations. for example, the focus on provincial-level initiatives excluded initiatives happening at regional, municipal and community levels. this selection was strategic in that it attempted to maximize the likelihood of finding initiatives which addressed the social determinants of health -conditions that require multi-sector, systemic change. it was assumed that this type of change more likely to happen at the provincial level as opposed to in a city or region, but it is possible that initiatives that address the social determinants of health at a more local level were overlooked. secondly, our search strategy was limited to initiatives that focused explicitly on healthy eating and active living and did not seek to identify social programs in other sectors (for example housing) that may address the social determinants of health and impact healthy eating and active living indirectly. we would like to emphasize, however, that our focus was on what is occurring within public health at a provincial level to improve healthy eating and active living. the presence of social programs in other sectors does not reduce public health's obligation or commitment to addressing the social determinants of health. finally, our analysis did not attempt to document whether desired outcomes related to the social determinants of health were achieved by the searched investing in prevention: improving health and creating sustainability: the provincial officer' s special report. british columbia: office of the provincial health officer commission on social determinants of health: closing the gap in a generation: health equity through action on the social determinants of health. final report of the commission on social determinants of health. geneva: world health organization social determinants of health: the canadian facts. toronto: york university school of health policy and management distribution of cardiovascular disease risk factors by socioeconomic status among canadian adults a % higher prevalence of life-shortening chronic conditions among 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social inequities in health national committee for public health: national goals for public health levelling off of prevalence of obesity in the adult population of sweden between / and / norwegian public health policy: revitalization of the social democratic welfare state? submit your next manuscript to biomed central and take full advantage of: • convenient online submission • thorough peer review • no space constraints or color figure charges • immediate publication on acceptance • inclusion in pubmed, cas, scopus and google scholar • research which is freely available for redistribution we thank the renewal of public health systems research team (website) and in particular dr. marjorie macdonald for allowing us access to their dataset in order to initially identify policy initiatives. we also thank drs. nicole berry and lorraine halinka malcoe who provided important insights into the subject matter and suggestions for the manuscript. ak is partially supported through a new investigator award from the canadian institutes of health research. initiatives; such outcomes require many years to manifest themselves. addressing the social determinants of health necessarily means moving away from depoliticized frameworks that emphasize biomedical factors in disease. attention to the social determinants and inequities has been growing, as health promotion movements evolve -movements that were initially led by canada. however it is necessary that health be seen for what it is: a political matter. as such, the health sector needs to diversify to a more political approach in finding solutions for health inequities. until this occurs, it is debatable how much progress can occur on improving the social determinants of health. additional file : bc healthy eating and active living initiatives analyzed ( ) .additional file : on healthy eating and active living initiatives analyzed ( ). the authors declare that they have no competing interests.authors' contributions dg conceived of the study, lead the analysis and drafted the manuscript. ak participated in refining the study's design, acted as a critical discussant of analytical findings and helped to draft the manuscript. both dg and ak read and approved the final manuscript. key: cord- -nu q l authors: iskander, john; strikas, raymond a.; gensheimer, kathleen f.; cox, nancy j.; redd, stephen c. title: pandemic influenza planning, united states, – date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: nu q l during the past century, influenza pandemics occurred. after the emergence of a novel influenza virus of swine origin in , national, state, and local us public health authorities began planning efforts to respond to future pandemics. several events have since stimulated progress in public health emergency planning: the avian influenza a(h n ) outbreak in hong kong, china; the anthrax attacks in the united states; the outbreak of severe acute respiratory syndrome; and the reemergence of influenza a(h n ) virus infection in humans. we outline the evolution of us pandemic planning since the late s, summarize planning accomplishments, and explain their ongoing importance. the public health community’s response to the influenza a(h n )pdm pandemic demonstrated the value of planning and provided insights into improving future plans and response efforts. preparedness planning will enhance the collective, multilevel response to future public health crises. influenza pandemics occur when an animal influenza virus to which humans have no or limited immunity acquires the ability, through genetic reassortment or mutation, to cause sustained human-to-human transmission leading to community-wide outbreaks ( ) . the existence of a pandemic is currently determined by the extent of disease spread, not by the lethality of the disease caused by the novel virus ( ) . during the twentieth century, influenza pandemics occurred in , , and . the pandemic, known as the "spanish flu" pandemic, was unique in that the highest number of deaths was among young, healthy persons. excess mortality in the united states during the pandemic was estimated at , deaths ( ) . the pandemics in and , although associated with death rates greater than those for seasonal influenza epidemics ( ), were far less devastating than the pandemic. before , public health planning for pandemics primarily occurred in response to detection of a novel influenza virus. this reactive mode continued despite the framework outlined in by us surgeon general l.e. burney for responding to the next pandemic. that framework involved recognition of the pandemic (i.e., surveillance), manufacture and distribution of vaccine, and identification of research needs ( ) . large-scale infectious disease response planning may have been hampered by the tacit assumption that the government's public health resources were better directed to other priorities. in january , a novel swine-origin influenza virus emerged among soldiers at fort dix, new jersey ( ); soldier died, and an estimated were infected. the emergence of influenza virus of swine origin at fort dix led to the decision to mount a national immunization program ( ) . the following events occurred subsequent to this decision: congress funded vaccine production and liability indemnification of manufacturers, vaccine was produced, a mass immunization campaign commenced, and . million persons were vaccinated in the united states ( ) . initial fears that the virus would cause a pandemic did not materialize: sustained transmission did not occur outside of fort dix. the vaccination campaign began in october and was halted in december because of initial reports of a rare association between the so-called "swine flu" vaccine and guillain-barré syndrome; the association was later confirmed ( ) . an influential policy review of the "swine flu affair" (i.e., the campaign to immunize the us population against a possible epidemic) identified several critical needs for future planning: ) a more cautious approach to interpreting limited data and communicating risk to the public, ) greater investment in research and preparedness, ) clearer operational responsibilities within the federal government, ) clear communication between planners at all levels of government, ) strengthened local capacity for plan implementation, and ) improved mechanisms for program evaluation ( ) . in november , separate from the fort dix outbreak, a strain of human influenza a(h n ) virus reemerged in the former soviet union, northeastern china, and hong kong, china, even though the virus had not circulated since . this strain primarily affected young persons, and caused mild illness ( ) . the virus was found to be closely related to a a(h n ) strain but dissimilar to the strain, suggesting that this outbreak strain had been preserved since ( ) . the confluence of fears of a possible pandemic in followed by the reemergence of a new strain of circulating seasonal influenza virus in led to focused pandemic planning efforts in the united states. the primary purpose of this article is to describe us pandemic planning during - , just before the onset of the influenza a(h n ) pdm pandemic in april . we believe that understanding the historical and policy context within which the a(h n )pdm pandemic occurred is helpful in assessing the implications of pandemic planning for responses to future pandemics and for ongoing infectious disease preparedness efforts. we conducted searches of the medical literature and key websites (e.g., www.pandemicflu.gov) for peer-reviewed manuscripts and published governmental plans relevant to pandemic planning during - . we also consulted authors' personal files and the internet for records of speeches, national and international conference proceedings, and other unpublished original source documents. in addition to published survey data concerning local and state response planning ( , ), we sought unpublished data from the association of state and territorial health officials, the national association of county and city health officials (naccho), and the council of state and territorial epidemiologists (cste). a historical overview of key milestones in us pandemic planning is provided in the table. in , a federal interagency working group on influenza was formed at the request of the deputy assistant secretary for health in the department of health, education, and welfare, partly in recognition of the need for greater cooperation across government "silos." the interagency group included representatives from the center for disease control (cdc; renamed centers for disease control and prevention in ), the national institutes of health, the food and drug administration (fda), and the department of defense. under cdc leadership, the work group drafted the first us pandemic plan, which was released in and included recommendations for annual influenza immunization of persons at high risk, strengthening of surveillance, expanding research, and establishing a planning and policy mechanism ( ) . the plan was revised in to include a new recommendation to develop means to distribute and use influenza antiviral drugs (r.a. strikas, pers. comm.). even before completion of the pandemic plan, participants of a conference on influenza, held by the secretary of the department of health, education, and welfare, recommended continued federal support for influenza vaccination, particularly to increase vaccination levels of persons at high risk, to improve pandemic preparedness. in addition, cdc implemented a federally funded seasonal influenza immunization program, which purchased . and . million vaccine doses for the - and - influenza seasons, respectively, of which ≈ million and > . million doses, respectively, were administered. initial plans were to purchase - million doses of vaccine. however, budget constraints limited vaccine purchases and ended the program after ( , ) . the next major event leading to further us pandemic planning was legislation creating the national vaccine program office (nvpo), which was given a mandate to coordinate federal vaccine-related activities. at the options for the control of influenza ii meeting held in , a consensus report identified the core components of pandemic preparedness: surveillance, vaccines, antiviral drugs, nonmedical/personal hygiene measures, communications, and enhanced annual seasonal influenza vaccination programs ( ) . in , nvpo formed the federal interagency group on influenza pandemic preparedness and emergency response (grippe). the group, which included nonfederal consultants and representatives from cdc, fda, the national institutes of health, and the department of defense, drafted a pandemic planning framework that was published in ( ) and updated by federal staff in ( ) . the grippe-initiated planning documents emphasized the need for enhancements to influenza surveillance, vaccine production and distribution, antiviral drugs, influenza research, and emergency preparedness. perhaps the most consequential outcome of grippe was the creation of a core group of public health experts dedicated to pandemic planning. global events helped accelerate interest in pandemic planning. in , hong kong recorded the first outbreak of avian influenza a(h n ) virus infections in humans. virus was transmitted from infected chickens directly to humans, and of persons with confirmed infection died. in late , > . million chickens were culled throughout hong kong as part of successful efforts to stem the outbreak ( ) . this event, combined with the reemergence of a(h n ) virus, led to concerns that the next pandemic would be caused by spread of a(h n ) virus through asia into africa and europe. in the united states, despite the crucial role of state and local authorities in implementing pandemic plans, a cste survey indicated that < % of state health departments perceived the need for a state-specific plan ( ) . through a cooperative agreement between cdc and cste, a state and local planning effort was begun in the fall of . the state project steering committee included the grippe co-chairs and representatives from cdc, nvpo, cste, and the association of public health laboratories. a meeting of > state and local health officials convened in september in atlanta and identified "pillars" deemed most critical for state and local pandemic preparedness efforts: ) surveillance, ) vaccine delivery, ) communication and coordination, and ) emergency response. from this meeting and subsequent subgroup meetings dedicated to the pillar areas, critical elements of draft state and local guidelines were developed by january . four states (connecticut, missouri, new mexico, and new york) and local area (east windsor township, new jersey) were selected by the state project steering committee-primarily on the basis of the identification of a key project leader within each jurisdiction-and funded to pilot test the draft guidelines; additional state, maine, volunteered to test the draft guidelines without cste support. these states conducted pilot tests during february and march and submitted results to cste. findings were discussed on april - , , at a meeting in atlanta. the major outcomes from pilot testing were the following recommendations: ) a fifth pillar area, guidance for use of antiviral drugs, should be added to the guide; ) the format of the guidelines should be more in concert with the national plan ( ) ; and ) all states should receive the revised guidelines to enable development of state-specific plans (r.a. strikas, pers. comm.). these issues were discussed at the association of state and territorial health officials/nac-cho annual meeting in september and incorporated into the state and local pandemic influenza planning guidelines (r.a. strikas, pers. comm.), which were then further revised. california, maryland, minnesota, and south carolina were funded through cste to develop state plans and submitted their model plans in april . a national pandemic influenza steering committee was subsequently formed; it was comprised of immunization ( ) . throughout this process, all states received the same nominal level of funding support, which was typically used to convene a statewide stakeholders meeting. elements critical to the planning process included technical support provided by the national steering committee and the identification of a key public health professional within each state who assumed responsibility for leading and coordinating planning efforts. arkansas, arizona, and oregon concurrently developed plans of their own accord; west virginia, tennessee ( ), and pennsylvania ( ) had already developed plans. ultimately, funds were sought for every state to develop a plan. at this early stage in the planning process, the importance of disseminating information to the broader public health community was recognized. on february , , and july , , cdc presented satellite videoconferences on influenza pandemic preparedness for states and local areas, which were viewed by > , and ≈ , participants, respectively. state and local public health staff engaged in development of pandemic plans participated in the broadcasts. at a meeting of state and local planners sponsored by cste and cdc in atlanta on september - , , detailed discussions were held regarding ) a scenario of how an influenza pandemic might affect states in ; ) how states should enhance surveillance; ) how vaccination priorities should be determined, and ) other national and federal pandemic planning issues, such as infection control, patient triage, and antiviral drug usage (r.a. strikas, pers. comm.). after the september , , terrorist attacks on the united states, public health preparedness emerged as a priority of the federal government. in , bioterrorism emergency funding support was provided to all states to assist in the nation's response to the anthrax attacks. the reemergence of avian influenza a(h n ) infections in humans fundamentally altered the scale of pandemic preparedness. as the a(h n ) virus spread to more countries in east and southeast asia during - , concern grew among senior policymakers and public health experts that the world was on the verge of an influenza pandemic. a(h n ) infection in humans primarily resulted from exposure to ill poultry and had a case-fatality rate of ≈ %. substantial federal funding was provided for federal-level planning, procurement of countermeasures (e.g., vaccines and antiviral drugs), development of countermeasures, and state and local pandemic preparedness efforts ( ) . state health departments eventually received $ million to prepare for an influenza pandemic. additional high-level policy engagement by the us federal government included the national strategy for pandemic influenza, which was announced in november ( ) , and the white house's national implementation plan, which was published in may and addressed federal planning and response strategies: international transport and border control; protection of human and animal health; and security and continuity of operations issues ( ) . in , the biomedical advanced research and development authority (barda) was established within the department of health and human services in response to the growing need for a centralized effort to coordinate research, development, and procurement of countermeasures against potential natural or intentional public health emergencies ( ). barda preparations for a possible a(h n ) pandemic included development of a stockpile of influenza vaccines produced by using strains circulating in poultry and wild birds in asia ( ). in addition, the us government began to purchase influenza antiviral medications for the strategic national stockpile sufficient to treat % of the us population. additional investments were initiated to procure ventilators and personal protective equipment, such as respirators. the us government also initiated an advanced development agenda for vaccines, therapeutics, and diagnostics. barda co-invested with industry to modernize vaccine production methods, with the -year aim of creating the capacity to produce sufficient vaccine to protect the entire us population within months of the onset of an influenza pandemic ( ) . the us government invested in modernizing diagnostic technologies for public health laboratories. in september , fda approved specific pcr tests for a panel of influenza diagnostics to be used in cdc reference laboratories in the united states and department of defense laboratories around the world. this diagnostic test panel will detect and identify a(h n ) infections and distinguish novel influenza virus infection from infection with seasonal a, b, and a(h ) and a(h ) influenza viruses. barda and cdc awarded contracts in november for development and evaluation of clinical point-of-care rapid diagnostics to identify seasonal influenza viruses and a(h n ) viruses ( ) . beginning with its first published pandemic plan in ( ) , the world health organization globally promoted pandemic planning among member states, with continued planning efforts thereafter ( ) . the international partnership on avian and pandemic influenza was formed to coordinate support for developing countries' efforts to control the spread of a(h n ) virus and to prepare for an influenza pandemic. this international body convened a series of meetings beginning in january ; these efforts generated hundreds of millions of dollars in pledges to support global pandemic preparedness and promoted a level of visibility and readiness that would not otherwise have been possible. in addition to direct financial assistance, the us government provided technical assistance to help countries develop capacities for rapid response, laboratory diagnosis, and surveillance. the federal government recognized that the foundation for domestic pandemic response rests with state and local governments; thus, the department of health and human services strategy and the white house strategy and implementation plan called for major efforts in planning, exercising, and refining state and local preparedness. the pandemic and all-hazards preparedness act called for a review of comprehensive state pandemic preparedness plans. the federal government reviewed and scored the plans and released the results to the public in january ( ); preparedness levels varied across states and across the domains that were scored. in , as part of its local health profile survey, naccho queried local health departments about emergency preparedness and planning activities they had undertaken during the past year ( ): % of , responding health departments said they had developed or updated pandemic influenza preparedness plans, and % said they had participated in tabletop drills or exercises. in addition, % had updated their written response plan on the basis of a postexercise after-action report, % had participated in a functional drill, and % had participated in a full-scale drill or exercise. a total of % of local health departments had reviewed existing state legal authorities for isolation and quarantine, and % had assessed the emergency preparedness competencies of staff. only % of local health departments did none of the above. the pandemic planning pillars-surveillance, vaccine and antiviral drug delivery, emergency response, and communication-are a solid foundation for pandemic preparation. although state pandemic plans may have different structures, reliance on these pillars has remained more or less constant across jurisdictions and over time. the major contemporary developments in these core areas are summarized below. surveillance, including rapid detection of human infection with novel influenza viruses, remains a cornerstone of pandemic response. this need has been recognized since the early stage of state-and local-based planning ( ) . improvements in diagnostic technology have enabled confirmation of infection with novel influenza viruses within hours rather than weeks. human infection with a novel influenza virus became a nationally notifiable disease in , and since then, an increased number of infections have been detected ( ). virologic surveillance is also used to determine which seasonal viruses are circulating and thus provides information for seasonal vaccine strain selection. systems to measure the effect of seasonal influenza (i.e., pediatric deaths, hospitalizations, and syndromic surveillance) have also been enhanced. these systems have been further adapted to measure the effect of pandemic influenza ( ) . the need to maintain ongoing surveillance for novel influenza viruses (e.g., viruses of swine or avian origin) in humans and animals exemplifies the one health concept ( ) . in recognition that vaccine might be in short supply during the early phase of a pandemic, federal vaccine allocation guidelines were published in ( ) . these guidelines laid the groundwork for the pandemic vaccine priority-group recommendations put forth during the a(h n )pdm pandemic ( ) . antiviral medications are critical to a pandemic response, particularly in the interval between recognition of the pandemic and the availability of vaccine. plans for using these countermeasures have stressed the need for early treatment of affected persons and assumed that the drugs would be scarce. it was recognized at the cste meeting that close coordination between emergency response staff and public health authorities is needed to develop and implement effective state and local influenza response plans. this recognition has strengthened over time. although, states were initially not allowed to use bioterrorism funds awarded in to support pandemic planning, key emergency management concepts, including the all-hazards approach and unified incident command, were eventually integrated into planning efforts ( ) . communication, more than ever, is a fundamental component of any response effort. timely, transparent, and proactive communication is critical, particularly in the early stages of a confirmed or suspected outbreak, when factual information is limited and the public demand for information and guidance is high. continuous media coverage and the evolving role of social media ( ) must be used to enhance communication to and from the public, particularly concerning new or evolving recommendations for disease control. pandemic planning since had a direct and obvious effect on the response to the influenza a(h n ) pdm pandemic; however, pandemic preparedness has been a feature of public health since the late s. coordinated state and federal planning processes have been a consistent feature of that planning. the pillars of pandemic planning response have remained conceptually constant: surveillance; vaccination and delivery of other medical countermeasures; emergency response coordination; and communications. although the a(h n )pdm pandemic spread globally within a matter of weeks, a -like pandemic did not materialize. nonetheless, this most recent pandemic resulted in ≈ , deaths in the united states, ≈ % of which occurred in persons < years of age ( ) . in the wake of this pandemic, the challenge in preparedness is to sustain the interest of private and public sectors in planning for a large-scale outbreak that may have a much more severe effect at a time that cannot be predicted. recent assessments of state level epidemiology capacity revealed potentially critical gaps in personnel and training needed for a rapid response to an epidemic ( ) . there will be a need for continued commitments to support state, local, and national planning for the next infectious disease emergency. a comprehensive, coordinated, and effective response cannot be built at the time of a crisis. for future planning and response efforts, sufficient resources are required to sustain the public health response infrastructure developed during the past decade. an effective response to a pandemic requires at least distinct elements. first, material resources, such as vaccines, antiviral drugs, and personal protective equipment are essential. second, a commitment to planning, exercising, and refining plans is necessary. third, a sufficiently large and robustly trained workforce is the basis of any response. fourth, a commitment to improvement is crucial. this concept extends from continuously improving plans and training to ensuring that scientific advances are incorporated into procurement and planning. one of the main lessons from the history of influenza is to expect the unexpected. plans and training should be flexible and designed to respond to various levels of disease severity or newly identified pathogens. benefits from pandemic preparedness will enhance our collective public health response to the next infectious disease crisis. dr iskander is a senior medical consultant in the office of the associate director for science, cdc. world health organization. pandemic influenza preparedness and response: a who guidance document us department of health and human services. about pandemics pandemic versus epidemic influenza mortality: a pattern of changing age distribution influenza pandemic: preparedness plans of the public health service swine influenza a outbreak from the national institute of allergy and infectious diseases of the national institutes of health, the center for disease control, and the bureau of biologics of the food and drug administration: a status report on national immunization against influenza guillain-barré syndrome following vaccination in the national influenza immunization program preparing for avian influenza: lessons from the "swine flu affair historical perspective-emergence of influenza a (h n ) viruses preparing for pandemic influenza: the need for enhanced surveillance influenza pandemic 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strategic action plan for pandemic influenza us government departments, agencies, and offices. assessment of states' operating plans to combat pandemic influenza national association of county and city health officials update: influenza a (h n )v transmission and guidelines-five states surveillance for influenza during the influenza a (h n ) pandemic-united states confronting zoonoses through closer collaboration between medicine and veterinary medicine (as 'one medicine') us department of health and human services and us department of homeland security. guidance on allocating and targeting pandemic influenza vaccine use of influenza a (h n ) monovalent vaccine: recommendations of the advisory committee on immunization practices (acip) influenza pandemic preparedness pandemics in the age of twitter: content analysis of tweets during the h n outbreak estimating the burden of pandemic influenza a (h n ) in the united states assessment of epidemiology capacity in state health departments-united states key: cord- -qckn lvx authors: cáceres, sigfrido burgos title: global health security in an era of global health threats date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: qckn lvx nan to the editor: global health security is the protection of the health of persons and societies worldwide. it includes access to medicines, vaccines, and health care, as well as reductions in collective vulnerabilities to global public health events that have the potential to spread across borders. for example, transboundary zoonotic diseases such as avian infl uenza (h n ) infections affect animals and humans, thereby threatening health security worldwide because of their high death rates (≈ % in humans) ( ) . during the past years, fairly standardized responses to threats have been implemented around the globe. some of these responses have been against severe acute respiratory syndrome and avian infl uenza (h n ), which have been overseen by a well-resourced international health system ( ) . these global health threats have raised the highest levels of political and social concern. this concern has provoked governments and international agencies to address health threats through a security rationale, which emphasizes the themes of national security, biosecurity, and human security. this amalgamation of health issues and security concerns has produced a notion of health security, which is dominated by technical medical approaches and pharmaceutical interventions. these approaches and interventions have already begun to shape the way international health policy is formulated ( ) . a global vision of health security is very much part of contemporary rhetoric. however, this vision lacks the drive and speed needed to make proposals materialize and operationalize ideas in the geographic areas where they are most desperately needed. small benefi ts accrue to members of vulnerable populations who, in fact, are those most likely to be affected by epidemic diseases. a public health security design that impinges on a global approach runs the risk of neglecting cultural, economic, ecologic, and social conditions on the ground. regional approaches that address hazards and threats may be more inclusive of context-specifi c conditions ( ) . global public health threats related to infectious pathogens of animal origin are expected to rise. to address these threats, several experts and strategists suggest the initiation of a worldwide early-alerting and -reporting mechanism. aggregation of disease threats through an eventfocused web-based platform could enable this mechanism. this timely gathering of disease intelligence can inform policymakers about the nature of risks. disease maps can display details needed to design tailored policies and control measures to tackle diseases according to their specifi cs ( ) . leading scientists and researchers continue to try to understand the global temporal and spatial patterns of animal diseases. this understanding is gained through an array of instruments, ranging from the use of satellite images to cutting-edge molecular technologies. the momentum so far has created an open forum for decisionmakers to collaborate with the leading international agencies to advocate for surveillance, identifi cation, and control of zoonotic diseases to uphold global public health security ( ). however, global initiatives suffer from the free-rider problem and from moral hazards. some low-income countries with weak governance have alerted the international community about their fragile health care systems to capture a nontrivial portion of funds that seldom reach their intended destinations. these resource allocations to developing countries foster aid dependence ( ). the international technical agencies tasked with upholding animal and human health should remain at the forefront of identifying and addressing evolving threats. this process will demand continuous fl exibility, agility, and a coordinated international effort. attaining goals of mitigating threats and reducing risks posed by the emergence of zoonoses requires close collaborations with national health authorities and local governments. the large investments planned to improve foresight and prevention might or might not work. if they do not work, apportioning blame to countries or regions for disease fl are-ups can result in social, political, cultural, and economic consequences that in the past have turned out to be unjustifi ed, unfair, and ultimately detrimental ( ). clearly, global health threats can be reduced only by the concerted actions of national and international actors. in the years ahead, the international community will almost certainly be expected to bring its formidable technical knowledge, skills, and analytic capabilities to confront this expanded global health threat environment ( ). it would be wrong, however, to forget the many insights that current advances in epidemiology and surveillance have delivered. in fact, should the impetus to fi nance a global health agenda encounter opposition or obstacles, it would seem easier and logical to strengthen already functional activities. lastly, the realities and the prevalent policymaking environment have created a trap between a desire to prioritize global health by portraying aspects of it as an existential security issue and the fact that security ultimately might not be the most useful language for describing and institutionalizing the health threats and hazards confronted by societies around the world ( ). regardless of whether a trap has been created, action is urgently needed. to the editor: we applaud mann et al. on their use of a school-based absenteeism surveillance system to compare daily all-causes absenteeism data against a historic baseline to detect outbreaks of infl uenza-like illness (ili) as an adjunct to traditional disease reporting ( ) . the growing availability of electronic human resources systems has increased the potential to harness near realtime workplace absenteeism data to complement school absenteeism surveillance and other sources of traditional outbreak surveillance. in london, united kingdom, during the fi rst wave of pandemic infl uenza a (h n ) , workplace absenteeism data from the transport for london attendance/absence reporting system were compared with the historical baseline -year mean for comparative weeks of the year. the proportion of transport for london employees absent because of selfreported or medically certifi ed ili, during june -october , , generated surveillance alerts when compared with historical baseline data above the th and th percentile thresholds (sds . and . ). for the same period, cause-specifi c workplace infl uenza absenteeism data were highly correlated with routinely published ili surveillance, including the national pandemic flu surveillance and sentinel general practitioner systems (figure) ( ). in australia, workplace all-causes absenteeism for a major australiawide employer has been included as a nonspecifi c indicator of infl uenza surveillance by the australian government for > years. a recent study during a severe infl uenza season in australia confi rmed that employee avian infl uenza: fact sheet avian infl uenza: science, policy and politics. london: earthscan security and global health. cambridge: polity epidemics: science, governance and social justice emerging zoonotic diseases in a changed world: strategic vision or fi re-fi ghting? key: cord- -ye hwhy authors: semenza, jan c.; sewe, maquines odhiambo; lindgren, elisabet; brusin, sergio; aaslav, kaja kaasik; mollet, thomas; rocklöv, joacim title: systemic resilience to cross‐border infectious disease threat events in europe date: - - journal: transbound emerg dis doi: . /tbed. sha: doc_id: cord_uid: ye hwhy recurrent health emergencies threaten global health security. international health regulations (ihr) aim to prevent, detect and respond to such threats, through increase in national public health core capacities, but whether ihr core capacity implementation is necessary and sufficient has been contested. with a longitudinal study we relate changes in national ihr core capacities to changes in cross‐border infectious disease threat events (idte) between and , collected through epidemic intelligence at the european centre for disease prevention and control (ecdc). by combining all ihr core capacities into one composite measure we found that a % increase in the mean of this composite ihr core capacity to be associated with a % decrease (p = . ) in the incidence of cross‐border idte in the eu. with respect to specific ihr core capacities, an individual increase in national legislation, policy & financing; coordination and communication with relevant sectors; surveillance; response; preparedness; risk communication; human resource capacity; or laboratory capacity was associated with a significant decrease in cross‐border idte incidence. in contrast, our analysis showed that ihr core capacities relating to point‐of‐entry, zoonotic events or food safety were not associated with idte in the eu. due to high internal correlations between core capacities, we conducted a principal component analysis which confirmed a % decrease in risk of idte for every % increase in the core capacity score ( % ci: . , . ). globally (eu excluded), a % increase in the mean of all ihr core capacities combined was associated with a % decrease (p = . ) in cross‐border idte incidence. we provide quantitative evidence that improvements in ihr core capacities at country‐level are associated with fewer cross‐border idte in the eu, which may also hold true for other parts of the world. global health security has been undermined by infectious disease threat events (idte) such as severe acute respiratory syndrome (sars) during (sars) during - (dzau, fuster, frazer, & snair, ; morens, folkers, & fauci, ; paules & fauci, ) . these idte have caused substantial human suffering, placed considerable pressure on government resources, and inflicted significant economic damage. in financial terms, the cost of potential pandemics can amount to us$ billion per year (sands, mundaca-shah, & dzau, ; sands, turabi, saynisch, & dzau, ) . however, if mortality costs are also taken into account, the annual cost can be as high as us$ billion (fan, summers, & jamison, ) . to prevent, protect against, control and provide a public health response to the international spread of disease, the world health organization (who) led efforts to update the international health regulations (ihr), and the updated regulations were adopted in and came into force in (gostin, debartolo, & friedman, ; world health organisation, ) . the aim was to prepare 'states parties' to be able to detect and respond to these threats more quickly and effectively. to prevent public health emergencies of international concern (pheic) that can be a threat to global health security, the ihr oblige all 'states parties' to establish ihr core capacities (table ) to detect, assess, notify and report events, and to respond to public health risks and emergencies. however, the persistent occurrence of idte post ihr implementation has raised questions about the implementation, compliance, and enforcement of these measures (commission on a global health risk framework for the future, ; gostin et al., ; gostin, debartolo, & katz, ; hoffman, ; suthar, allen, cifuentes, dye, & nagata, ; world health organisation, ) help to identify deficiencies in ihr core capacities and ihr non-compliance, additional factors might be responsible for the emergence of idte (gostin et al., , . it is possible that ihr core capacities are necessary but not sufficient to prevent the spread, control or response to such threats. they might not comprehensively identify and mitigate all the underlying drivers and determinants of idte in an increasingly interconnected and interdependent world (glaesser, kester, paulose, alizadeh, & valentin, ; jones et al., ; morens et al., ; paules & fauci, ; semenza, rocklov, penttinen, & lindgren, ; weiss & mcmichael, in europe as a result of global resurgence, increasing mobility and low vaccine uptake, in part related to vaccine hesitancy (leong, ; massad, ) . in , the chikungunya virus was introduced into france and italy by viraemic passengers and spread by aedes albopictus mosquitoes, in part due to favourable climatic conditions (lillepold, rocklov, liu-helmersson, sewe, & semenza, ; rezza, ; rocklöv et al., ; semenza & suk, ) . international donors invested us$ . billion in outbreak preparedness, response and management of cross-border externalities in (schaferhoff et al., ) and national governments have allocated substantial resources to ihr core capacity implementation. the ecdc is an eu agency with a mission to monitor, identify (early warning and assessment) and respond to serious cross-border health union, ) this is analogous to the world health organization (who) ihr, where countries are also committed to further build their capacities to detect, assess and notify, and report on public health emergencies of international concern. thus, the cross-border idte we analyse here lend themselves to an analysis of ihr core capacities. european centre for disease prevention and control conducts epidemic intelligence, a process of systematic collection and collation of information on threats from health from a variety of sources. cross-border idte are assessed and verified to ensure they correspond to real public health events (for examples of idte see semenza, rocklov, et al., ) ). the assessment is based on an analysis, using ihr and early warning and response system (ewrs) criteria and expert opinion (table s ). ecdc initiated data collection for epidemic intelligence in june . we analysed cross-border idte that originated in one of the eu member states (eu ) from to . this time period included the migrant wave of (semenza, carrillo-santisteve, et al., ) . we included idte with a risk of introduction to or propagation between member states within the eu/eea and idte that may require timely and coordinated eu action to contain (table s ). we also analysed cross-border idte for other parts of the world that were recorded by ecdc epidemic intelligence, despite the low numbers of idte identified in those countries. we excluded travelassociated legionnaires' disease outbreaks not originating in the eu from the analysis due to changes in reporting during the study period. who has developed an analytical framework for monitoring the achievement of ihr core capacities (world health organisation, ) . it allows country data for each core capacity, poe and potential hazards to be analysed in detail (table ) organisation, ). the main purpose of the framework is to enable countries to measure their current status and assess progress over time. although individual ihr core capacities do not necessarily carry the same weight in an assessment of capabilities, all attributes are given the same weight in the framework. the scores range from % to % and were available from to (world health organisation). the analysis also included potential hazard (zoonotic events) and potential hazard (food safety); however, potential hazard (chemical events) and potential hazard (radiation emergencies) were not included in this analysis as they do not relate directly to idte. we determined the incidence of cross-border idte per capita in different countries based on the annual number of idte in a country divided by the annual population of the country. we modelled the relative change in the incidence of cross-border idte that originated in one country of the eu , with a panel study, using a longitudinal general estimation equation framework (gee) (hanley, negassa, edwardes, & forrester, ) with a poisson log-link using random effects by country of origin to adjust for unmeasured confounders. we used an exchangeable correlation structure of the observations within countries, not to make prior assumptions of the temporal covariance structure. initially, we performed univariate analysis of the association of each of the ihr core capacities to cross-border a total of cross-border idte in the eu met the study inclusion criteria between and (tables ; s ). over the study period, the composite measure of the ihr core capacities, which averages capacities ( analysis of idte in other parts of the world (besides eu ) was constrained by few cross-border idte detected in these countries and reported to ecdc. nevertheless, a % increase in the mean of all ihr core capacities combined was associated with a % decrease (p = . ) in the incidence of cross-border idte in countries other than the eu . due to sample size constraints, a regional analysis was not possible. the results for specific ihr core capacities for all non-eu countries combined is provided in the supporting information (table s ) . with respect to the association of a % increase in individual core capacities with the incidence of cross-border idte in the eu , core capacity (national legislation, policy and financing) was associated with a % decrease ( % ci: . , . ) in the incidence of cross-border idte ( figure ); core capacity (coordination and figure ) . a bivariate analysis adjusted for gdp per capita yielded essentially the same point estimates (table s ). the principal component analysis revealed that three components explained the majority of variability of the ihr core capacities (table s ) . however, only the first pca score was significantly related to idte with an estimated % decrease in risk for every % increase in the core capacity score ( % ci: . , . ). the individual core capacity weights related to this component was in line with the univariate analysis by relating mainly to ihr core capacities and less so to hazards. the irr estimate from the first pca score was also very similar to the estimate from the average composite measure of the ihr core capacities (decrease % vs. %), and further indicated that the irr from the univariate analysis of ihr core capacities cannot be combined, due to the strong inter-core capacity correlations. & semenza, ; wolicki et al., ) . to this end, surveillance needs to be flexible and sensitive and to encompass syndromic, laboratory-based, population-based and sentinel systems (wolicki et al., ) . in our analysis, national surveillance was associated with fewer idte, presumably because they were intercepted prior to international spread. response (core capacity ) was highly significant in our analysis. systemic resilience to idte entails management and coordination of operations to rapidly respond to epidemic events that could develop into public health emergencies of national or international concern. it also includes active case management, infection control and decontamination, the importance of which were demonstrated during the mers-cov and ebola outbreaks in and , respectively (siedner, gostin, cranmer, & kraemer, ; zaki, boheemen, bestebroer, osterhaus, & fouchier, ) . in our analysis, preparedness (core capacity ) was also pro- sharing of infectious agents must occur through national or collaborating centres (gostin et al., to the contrary, vaccination coverage for example, has declined in certain countries (e.g. italy). it is important to bear in mind that this longitudinal study has a much stronger plausibility of an inference of a causal association than a simple cross-sectional study. we relate a change in ihr core capacities to a change in idte over time. thus, due to this temporal association, the causal inference is high, but nevertheless potentially subject to biases. another potential bias is reporting bias due to the self-assessment of ihr core capacities (gostin et al., ) which could have shifted our results to the null. selective reporting could also have contributed to the high inter-core capacity correlations, which decreases the granularity of our results. to overcome this lack of objective metrics, who has introduced a joint external evaluation (jee) as part of the ihr monitoring and evaluation framework (bell et al., ; world health organisation, a ). this is a voluntary, multi-sectoral, peer-to-peer process with external experts to assess country capacity to prevent, detect and rapidly respond to public health risks. such an assessment is likely to be more objective than a self-assessment of ihr core capacities. as of april , countries had conducted a jee, but only five of these countries were eu member states (belgium, finland, latvia, lithuania and slovenia) (world health organisation, b). once all eu countries have completed a jee, analysis of the association with idte will need to be revisited. we would like to thank dr. piotr kramarz (ecdc) and two anonymous reviewers for critical feedback on our manuscript. the views and opinions expressed herein are the authors' own and do not necessarily state or reflect those of ecdc. ecdc is not responsible for the data and information collation and analysis and cannot be held liable for conclusions or opinions drawn. no conflict of interest. jcs conceived the study, developed the study design, led the data analysis and data interpretation, and wrote the manuscript. mos conducted the analysis and contributed to the writing. el contributed to the writing. sb, kka and tm collected epidemic intelligence data. jr led the data analysis and contributed to the writing of the manuscript. all authors reviewed and approved the final manuscript. jan c. semenza https://orcid.org/ - - - x the neglected dimension of global security -a framework to counter infectious disease crises available from: https ://www.nap.edu/catal og/ / the-negle cted-dimen sion-of-global-secur ity-a-frame work-to-counter. investing in global health for our future the iclusive cost of pandemic influenza risk ebola in west 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monitoring and evaluation framework ihr monitoring & evaluation isolation of a novel coronavirus from a man with pneumonia in saudi arabia additional supporting information may be found online in the supporting information section at the end of the article. how to cite this article key: cord- - w c qr authors: ojong, nathanael title: the covid- pandemic and the pathology of the economic and political architecture in cameroon date: - - journal: healthcare (basel) doi: . /healthcare sha: doc_id: cord_uid: w c qr this article examines the factors restricting an effective response to the covid- pandemic in cameroon. it argues that structural adjustment policies in the s and s as well as corruption and limited investment in recent times have severely weakened the country’s health system. this article also emphasises the interconnection between poverty, slums, and covid- . this interconnection brings to the fore inequality in cameroon. arguably, this inequality could facilitate the spread of covid- in the country. this article draws attention to the political forces shaping the response to the pandemic and contends that in some regions in the country, the lack of an effective response to the pandemic may not necessarily be due to a lack of resources. in so doing, it critiques the covid- orthodoxy that focuses exclusively on the pathology of the disease and advocates “technical” solutions to the pandemic, while ignoring the political and socio-economic forces that shape the fight against the pandemic. at times, medical supplies and other forms of assistance may be available, but structural violence impairs access to these resources. politics must be brought into the covid- discourse, as it shapes the response to the pandemic. the current coronavirus disease (covid- ) pandemic started in december [ ] , and on december , china informed the world health organisation (who) of numerous cases of pneumonia of unknown cause in wuhan, a city of million inhabitants [ ] . initially, a significant proportion of those affected worked at the city's huanan seafood wholesale market. three weeks later, there were confirmed cases in the us, thailand, nepal, france, australia, malaysia, singapore, south korea, vietnam, and taiwan. the who's director-general, dr. tedros adhanom ghebreyesus, declared the novel coronavirus outbreak a public health emergency of international concern on january , after the number of cases increased more than tenfold in a week [ ] . by this time, there were confirmed cases in countries, excluding china. on february , the who announced a name for the new coronavirus disease: covid- . on march , the who's director-general said that the institution was "deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction", and concluded that "we have therefore made the assessment that covid- can be characterised as a pandemic" [ ] . by this time, there were over , cases in countries, with deaths [ ] . by may , there were over three million confirmed cases and over , deaths in countries [ ] . in declaring covid- a pandemic, the who's director-general noted that the "greatest concern is the potential for this virus to spread to countries with weaker health systems which are ill-prepared to deal with it" [ ] . most african countries have weak health systems, including inadequate surveillance and laboratory capacity and limited medical personnel [ ] . as of february , only this review draws on secondary data sources, and the evidence presented is based first on the growing body of literature regarding the covid- pandemic from a variety of institutional fora. a significant proportion of this work has been carried out by people directly or indirectly associated with international institutions (e.g., the world health organisation and world bank), academic institutions, news agencies, national government departments, and non-governmental organisations (ngos). in some cases, data from these sources were readily available online. this paper relies heavily on scholarly and national government literature to historicize the state of the health sector, while some of the evidence supporting the analysis is drawn from local and international news agencies. the evidence provided by these news agencies is current, which explains why they are used to shed light on contemporary issues related to health care, including covid- . additionally, news agencies often bring to the attention of the public issues that governments are not ready to disclose for political reasons, and scholars have endorsed the use of these sources [ , ] . the use of these secondary sources poses some limitations, as local new agencies may be biased regarding reportage [ ] . to minimise this problem, evidence is drawn from a variety of national and international news agencies. additionally, the statistics provided by national government agencies should be considered with caution, as across multiple african countries, there are discrepancies between administrative data and independent household surveys [ ] . several african countries also misreport to foreign donors [ ] . so, these limitations should be taken into consideration when engaging with discussions in this paper. that said, the goal of this review is to provide a deeper understanding of the factors that have contributed to weakening cameroon's health sector over the years and to shed light on socio-economic and political factors that are currently restricting an effective response to the pandemic in the country. coronaviruses are pathogens that primarily target the respiratory system in humans [ ] . the most common symptoms at the onset of covid- are fever, cough, and fatigue, while other symptoms include headache, sputum production, hemoptysis, dyspnoea, diarrhoea, and lymphopenia [ ] [ ] [ ] . the incubation period for covid- , i.e., the time between exposure to the virus and symptom onset, is on average - days, but can be up to days [ ] . however, some people are asymptomatic, meaning that they are infected with covid- but do not develop symptoms. scholars have suggested that a "wet market" in wuhan city where live animals are often sold may be the zoonotic origin of covid- [ ] . the who has classified covid- as a β-coronavirus of group b [ ] , with a genome that is highly similar to bat coronavirus, thus pointing to bats as the natural host [ , ] . research has shown that some bat sarsr-covs have the potential to infect humans [ , ] . it seems that most of the early confirmed cases had a contact history with the original wet market in wuhan [ ] ; however, covid- is currently being transmitted by human-to-human contact. covid- uses the same receptor, angiotensin-converting enzyme (ace ), as that for sars-cov, and spreads principally through the respiratory tract [ ] . human-to-human transmission occurs primarily through direct contact or through droplets spread from an infected person by coughing or sneezing [ ] . human-to-human transmission has accounted for the proliferation of covid- across the globe. a strong health care system is vital in handling confirmed cases and reducing the covid- fatality rate. as was mentioned earlier, cameroon, like other african countries, has a weak health care system. so, what is the state of cameroon's health system, and what factors have contributed to weakening it? the public health sector is considered one of the driving forces of cameroon's health care system due to its core objectives of disease prevention and providing and improving health services to its population. public health facilities are organised into seven categories: general hospitals, central hospitals, regional hospitals, district hospitals, district medical centres, integrated health centres, and ambulatory health centres [ ] . in addition to these seven groups, there are also private clinics, health facilities operated by religious organisations and ngos, and traditional health institutions. quantitatively, in , there were public and private health facilities in the country (table )-of which, . % were private institutions (i.e., for-profit or non-profit institutions) [ ] . some public health institutions are not fully functional due to lack of equipment, and where equipment exists, it is obsolete or of poor quality [ ] . one study identified a lack of delivery kits ( . %), dry-heat sterilization systems ( . %), caesarean section kits ( . %), and functional microscopes ( . %) in health institutions in the country [ ] . the ratio of health personnel (medical doctors, midwives, and nurses) to the regular population is . per inhabitants [ , ] . more precisely, there are . doctors per , people, and hospital beds per , people [ ] . in some administrative regions, the proportion is as low as . doctors per , people ( table ). the government admits that public health institutions are understaffed [ ] . public resources allocated to the health sector in cameroon remain some of the lowest in africa in terms of gdp [ , ] . out of the us$ per cameroonian spent on health care in , the government contributed only us$ , i.e., %-of which, us$ was provided by international donors [ ] . therefore, the cost of health care is largely borne by individuals through out-of-pocket payments. in , out of us$ per person spent on health care in the country, us$ was out-of-pocket spending, us$ was government spending, us$ was development assistance for health, and us$ was prepaid private spending [ ] . the national and international press have reported cases in cities such as douala and yaoundé where people were denied health care or detained because of their inability to pay their health care bills. in , the bbc reported the case of a mother and baby who were detained for months by a hospital in yaoundé due to the mother's inability to pay her medical bill [ ] , and in , the france-based news agency france reported that a hospital in the capital city, yaoundé, detained 'about a dozen mothers and their newborns in a small room for about a month because they were unable to pay the hospital fees for the birth by caesarean section' [ ] . people have also had to rely on out-of-pocket payments to cover health care costs related to covid- . an independent local news agency in the country reported that some public health institutions in douala required covid- patients to cover their health care costs. the news agency interviewed the spouse of a covid- patient who, after spending approximately , fcfa ($ ) on tests and prescription drugs, turned to the use of free herbal medicine provided by the archbishop of the douala metropolitan archdiocese, his lordship samuel kleda [ ] . the country's minister of public health, dr. malachie manaouda, in a press release published on april , declared a ban on the systematic billing for screening tests, hospitalisations, and administration of prescription drugs. however, two weeks after the minister's press statement, people in douala, for example, were still relying on out-of-pocket payments for covid- -related medical expenses [ ] . the confusion surrounding the requirement of covid- patients to cover their medical bills is captured in the following statement by the director of the douala gyneco-obstetric hospital, prof. emile mboudou: "is it possible that the hospital gives you a prescription and also gives you the money to buy the prescribed drugs in a pharmacy? we have not received a drug endowment until now at the douala gyneco-obstetric hospital" [ ] . this case depicts a lack of coordination between the ministries of public health and finance. the former has the technical authority to instruct medical facilities not to charge covid- patients, but for this policy to take effect, the latter must make the funds available to the medical institutions to cover the costs. the covid- pandemic has made manifest cameroon's weak health system. as of april , the country had just four testing laboratories, with three of them in the capital yaoundé [ ] . a medical doctor in douala, the country's economic capital, noted: "there are less than ventilators in the whole city. we are having challenges in treating patients with acute respiratory distress" [ ] . the country's prime minister, joseph dion ngute, announced plans to transform eight venues into makeshift medical facilities to be used for the treatment and follow-up of covid- patients, but the construction of these makeshift medical facilities, as well as equipping them, has been slow [ ] . as of april , none of these makeshift medical facilities was ready to receive covid- cases. cameroon has received external support to fight covid- . the country received medical supplies from unicef and jack ma's alibaba foundation [ ] , vehicles from the who, and financial support from countries such as the united states of america [ ] and switzerland [ ] . the ngo doctors without borders (médecins sans frontières) has also been supporting the country's response to the covid- pandemic. although the humanitarian assistance provided is laudable and timely, it reinforces structures of dependence, and history tells us that the country is likely to continue to depend on external assistance, including foreign experts to tackle future epidemics. scholars have argued that sub-saharan african countries which receive aid are less likely to have incentives to invest in effective public institutions [ ] . therefore, the government may not have the incentives to invest in the health care system, as it is well aware that it can always count on external support in times of emergency. undoubtedly, covid- has exposed cameroon's weak health care system, and to understand the current state of the country's health system, it is important to investigate its roots. put simply, it is important to examine the factors that have contributed to weakening the country's health system. cameroon's weak health system can be traced to the years of structural adjustment which began in the mid- s. after independence, cameroon enjoyed relative economic prosperity until the mid- s. from to , its economy grew annually at approximately % [ ] , which led us president ronald reagan to refer to the country as a 'shining example for africa' [ ] . this growth was mostly due to the boom in exports of cash crops. in , cash crops made up . % of exports, while oil comprised only . % [ ] . the structure of the country's economy changed in the s because of oil exploration. in , oil made up . % of exports and cash crops . %, with the government receiving high royalties from international oil companies developing the field [ ] . according to the world development indicators database, gdp per capita (in us$) increased from $ . in to $ . in . however, cameroon's impressive economic performance was short lived, and in / , a drop-in oil revenue due to a simultaneous reduction in prices and exploitable sites and a decline in the terms of trade for cash crop exports slowed down the economy's growth [ ] . farm prices for cocoa, arabica and robusta coffee, rice, and cotton declined by , , , , and %, respectively [ ] . accompanying the sluggish economy were budget and balance-of-payment deficits, a build-up of internal arrears, a rise in foreign indebtedness, and worsening solvency problems for commercial banks [ ] . external borrowing and reserves held abroad permitted the government to push back any sort of reform until , when president paul biya announced some budget cuts [ ] . however, this measure failed to remedy the situation, and deficits continued to rise. between and , real gdp fell by %, the external deficit averaged % of gdp, foreign debts tripled to over % of gdp, and the debt-service ratio increased to % [ ] . by , the government had no option but to enter into a structural adjustment agreement with the world bank [ ] . structural adjustment policies in cameroon included devaluing the currency, cutting public expenditures, eliminating subsidies, promoting exports, especially agricultural, and liberalising trade [ ] . pay cuts were introduced in ( %) and ( % at first, and later %) [ ] . prior to the pay cuts in , an integrated public employee on index earned a gross salary of , fcfa (us$ ), and after the cuts, their salary decreased to , fcfa (us$ ), i.e., a . % reduction in pay [ , ] . then, in , there was a % devaluation of the fcfa in return for $ million in credit ratified by the international monetary fund [ ] . additionally, as of , public service employees began to experience delays in salary payments which usually exceeded three months [ ] . according to the world development indicators database, per capita gdp (in us$) decreased from $ . in to $ . in . the world bank-and imf-sponsored structural adjustment programmes severely affected the public health sector in the country, and there was no recruitment of people into the public health sector for years [ ] . further, there was little investment in health infrastructure [ ] . paramedical training for laboratory technicians and nurses was suspended for several years, and training schools closed [ ] . low salaries and poor working conditions [ ] led public health personnel to move to the private health sector where salaries were higher [ ] , or to move abroad [ ] . in , public health sector jobs were approximately % unfilled [ ] . unsurprisingly, the structural adjustment policies also directly affected users of public health institutions. government spending on public services was curtailed, and "health became a commodity and an individual responsibility" [ ] . the government implemented a health cost recovery system that required users of public health institutions to cover their health care costs, and this implementation of out-of-pocket payments amid chronic poverty pushed people to turn to alternatives such as self-medication, traditional medicine, and drugs from street vendors [ ] . drugs purchased on the street are often counterfeit or substandard, causing harm to patients as well as failing to treat the diseases for which they are intended. people's decisions to purchase counterfeit or substandard drugs on the street were not solely due to the cost of these products in formal health care institutions. the government's reduction in health spending meant that some public health institutions did not have the medications required by patients, leading the latter to purchase drugs on the street [ ] . unlike the public health institutions, people did not have to travel long distances to purchase counterfeit or substandard drugs, as these were readily available in local communities. put simply, availability and accessibility were and remain key contributory factors to the proliferation of counterfeit or substandard drugs in the country [ ] . the shortage of drugs in public health institutions was also linked to chronic corruption, which remains pervasive in the country. cameroon was ranked the most corrupt country in (out of countries surveyed) and (out of countries surveyed), and in it ranked rd out of countries in the corruption perception index. cameroon's score of out of indicates serious levels of public sector corruption [ ] . regarding judicial independence, in , the country had a value of . out of , indicating that its judicial system is seriously influenced by members of the government as well as private citizens and firms [ ] . in the past, there has been large-scale drug thefts and small-scale pilfering, and the limited drugs that reached public health care institutions due to the reduction in public health expenditures were given to local authorities, family members, and friends before patients could benefit from them [ ] . it is no coincidence that data from the household survey conducted by the government show that approximately % of household heads in urban and semi-urban areas noted the high level of corruption in the public health sector [ ] . a study conducted in the city of douala found that in order to avoid long wait times to see a doctor, people offered bribes in order to enable them to skip the queue [ ] . additionally, some doctors in public hospitals operate private clinics, so when patients go for consultation in public hospitals, these doctors often direct them to their own clinics, where costs are significantly higher [ ] , and this practice also increases the total health care costs borne by patients. funds provided by external partners, intended to help the government strengthen the country's health system, have been misused too. this was the case for funds provided by the gavi alliance, a public-private partnership whose mission is to save children's lives and protect people's health by increasing access to immunisation in the global south. the gavi alliance uncovered massive misuse of its grants in cameroon in , and an investigation led by the alliance revealed that "of us$ . million programme expenditures, us$ . million had been misspent, partly due to fraud. different types of corruption affected this programme" [ ] . the investigation highlighted fraud in purchasing (e.g., non-existent suppliers, order-splitting to avoid tender, fake invoices, over-invoicing of - % higher than market prices, purchase of incompatible supplies, unjustified repairs), fraud in activities (e.g., funding of fictitious activities, funding of activities already funded by other partners, withdrawals for activities not undertaken, payment of unauthorized per diems), and unjustified cash disbursements (e.g., discrepancies between bank withdrawals and the amounts in supporting documentation). in fact, a business address on one of the fake invoices was found to actually be a cemetery, and 'brand new vehicles were allegedly subjected to "repairs" costing thousands of dollars' [ ] . several top government officials have been imprisoned for corruption. for example, in , a former finance and economy minister was sentenced to years in prison for embezzling us$ million [ ] . however, some political analysts contend that the arrest and imprisonment of some high-profile government officials, allegedly for embezzlement of funds, is politically motivated [ ] . the government claims that the country has lost approximately us$ . billion in stolen funds [ ] , but corruption is just one of several factors which have contributed to weakening the country's health system. deepening the problems is the limited state investment in health care, and even after the country entered a period of successive gdp growth, there was no significant increase in health spending as a percentage of government expenditures (figure ). instead of an increase in public health spending as a percentage of general government expenditures, there has been a decrease; e.g., between and , the country recorded an annual gdp growth rate of at least %, but there was a decrease in health expenditure as a percentage of general government spending from % in to . % in , and then to . % in ( figure ) . so, the weak health care system is also due to years of inadequate investment in the public health sector. the point emphasised here and elsewhere is that state institutions shape the response to covid- , and put differently, this trend is indicative of how structural violence hampers the fight against the disease. by structural violence, i refer to the 'way institutions and practices inflict avoidable harm by impairing basic human needs' [ ] . apart from the weak health care system, however, there are several other factors restricting an effective response to the covid- pandemic. so far, i have examined the factors which have contributed to weakening cameroon's health care system. as the fight against the covid- pandemic requires bringing together various vital elements, this section focuses on the socio-economic and political factors currently restricting an effective response to the pandemic. in addition to the weak health care system, other factors such as poverty and a lack of basic amenities are hindering the fight against covid- . according to the country's national institute of statistics, approximately . % of the population lives below the national poverty line of fcfa (us$ . ) per day [ ] . the world bank noted that between and , the number of poor people increased by %, to approximately million. however, these figures should be considered with caution, as there is a consensus among researchers that official statistics in several sub-saharan african (ssa) countries are inadequate and unreliable [ , ] -what shantayanan devarajan refers to as the "statistical strategy" [ ] . unemployment among those aged to is approximately %, but crucially, underemployment is . % at the national level and . % and . % in urban and rural zones, respectively [ ] , while informal employment stands at . % [ ] . the precariousness of everyday life makes it challenging to prevent the spread of covid- . on march , the government announced restrictive measures, including the closure of land, air, and sea borders, closure of schools, a ban on gatherings of more than people, and a restriction of non-essential urban and interurban travel within the country. from the beginning, however, it was clear that it would be difficult to implement these measures. it is challenging to ensure physical distancing and the flow of people in marketplaces which are often overcrowded, especially when a significant proportion of the population is not cooperative. moreover, as earlier mentioned, over % of the population relies on the informal economy for a living, and since the functioning of the informal economy is based on the movement of people, without an outright lockdown, it is almost impossible to prevent the interurban travel of informal workers. as well, the government may not be willing to impose a lockdown since over % of the working population have livelihoods in the informal economy. additionally, the government made it obligatory from april for people to wear face masks whenever appearing in public as part of measures to slow the spread of the disease, but due to the high poverty rate in the country, most people say they cannot afford a mask. so far, i have examined the factors which have contributed to weakening cameroon's health care system. as the fight against the covid- pandemic requires bringing together various vital elements, this section focuses on the socio-economic and political factors currently restricting an effective response to the pandemic. in addition to the weak health care system, other factors such as poverty and a lack of basic amenities are hindering the fight against covid- . according to the country's national institute of statistics, approximately . % of the population lives below the national poverty line of fcfa (us$ . ) per day [ ] . the world bank noted that between and , the number of poor people increased by %, to approximately million. however, these figures should be considered with caution, as there is a consensus among researchers that official statistics in several sub-saharan african (ssa) countries are inadequate and unreliable [ , ] -what shantayanan devarajan refers to as the "statistical strategy" [ ] . unemployment among those aged to is approximately %, but crucially, underemployment is . % at the national level and . % and . % in urban and rural zones, respectively [ ] , while informal employment stands at . % [ ] . the precariousness of everyday life makes it challenging to prevent the spread of covid- . on march , the government announced restrictive measures, including the closure of land, air, and sea borders, closure of schools, a ban on gatherings of more than people, and a restriction of non-essential urban and interurban travel within the country. from the beginning, however, it was clear that it would be difficult to implement these measures. it is challenging to ensure physical distancing and the flow of people in marketplaces which are often overcrowded, especially when a significant proportion of the population is not cooperative. moreover, as earlier mentioned, over % of the population relies on the informal economy for a living, and since the functioning of the informal economy is based on the movement of people, without an outright lockdown, it is almost impossible to prevent the interurban travel of informal workers. as well, the government may not be willing to impose a lockdown since over % of the working population have livelihoods in the informal economy. additionally, the government made it obligatory from april for people to wear face masks whenever appearing in public as part of measures to slow the spread of the disease, but due to the high poverty rate in the country, most people say they cannot afford a mask. a lack of basic amenities is also affecting the fight against the pandemic. frequent power outages in the country render it difficult for people who have food preservation appliances to make use of them, and for low-income populations who cannot afford a power generator, this means they must go out on a regular basis to purchase fresh food. water shortages also plague major cities in the country. the over three million residents in the country's capital, yaoundé, require a daily supply of approximately , cubic meters of clean water, but only % of this is provided [ ] . it is tough persuading someone staying in a one-room unit with family members, without water and power, to stay indoors as much as possible and only go out when necessary. additionally, the closure of schools has simply moved most primary and secondary school students from low-income households from the classroom to the streets. in order to make ends meet in the household, some parents send their children to sell goods in the streets and marketplaces. one student told a local news agency that "we are afraid to contract covid- but we have to sell; we won't have food to eat if we stay home" [ ] . another said that since the schools closed, she had been helping her mother sell goods in the market, adding that they would not have food to eat if they did not perform these activities [ ] . as those who make a living in the informal economy have no income if they do not work, they are forced to continue their activities even at the risk of contracting the disease. crucially, the discussion regarding poverty shows how it causes the spread of covid- , as low-income populations who work in the informal economy are forced to go outside in order to gain income, and as they often work in crowded environments, this exposes them to the virus. when they get the virus, it is likely to spread faster within their households, as they are often overcrowded. different households in the slums often share toilets and bathrooms [ ] , thus facilitating the spread of the virus from one household to another. scholars have documented the complex interconnections between poverty, slums, and disease in africa [ , ] . the interconnections between poverty, slums, and covid- bring to the fore the social inequality in cameroonian society. pandemics rarely affect populations in a uniform way [ ] , and arguably, the experiences with covid- , i.e., the nature of the infection, the rate of spread, and access to medical care, vary according to class. as mentioned earlier, low-income populations are more likely to get infected; the upper class can self-impose lockdowns, as they have food, power generators, access to potable water and the internet, and their households are not overcrowded. their status in everyday life reduces their rates of infection, and those who get infected can afford quality medical care. i do not suggest, however, that the better-off populations constitute a homogenous class. the point emphasised here is the different impacts of covid- on different populations. arguably, if low-income populations are more likely to get infected and spread it to others in their households and communities, one might argue that inequality may facilitate the spread of covid- in the country. scholars have put forward points that seem to support the relationship between inequality and the spread of covid- [ ] . in addition to the issues of poverty and social inequality, weak enforcement mechanisms also restrict effective responses to the pandemic. to prevent the spread of the disease, the government recommended that travellers coming into the country be quarantined for days, and travellers arriving at international airports in douala and yaoundé were taken to hotels in these cities for quarantine. however, some of these people received visits in their hotel rooms from family members, friends, and even prostitutes. a top government official in the administrative division of mfoundi, where yaoundé is located, angrily noted, "we discovered that people put in quarantine were conniving with hotel agents [workers] to smuggle women into the hotel to sleep with them. we have arrested some of them. we have to work together to stop this virus" [ ] . the official added that he ordered the arrest of prostitutes as well as women and six men who had sneaked into hotels to meet their spouses [ ] . moreover, of those quarantined escaped from their hotels, and people who returned to the country from france and italy refused to be isolated [ ] . in cameroon, the locals often say that "money speaks"-in other words, people in a sound financial position can make things happen. most of those who escaped were people who had returned from western countries such as france, italy and belgium, and their social class may have made it easier for them to disregard the guidelines. the violators seem to have exploited the country's weak enforcement mechanisms, as people tend to get different treatment based on their social class. the who has urged national governments to "find, isolate, test and treat every case and trace every contact" [ ], but it is challenging to implement this protocol in an environment where corruption is pervasive and where there are weak law enforcement mechanisms. the current political climate in cameroon is affecting the fight against the covid- pandemic there. as mentioned earlier, there is armed conflict in the far north, northwest, and southwest regions. what began in as a political crisis linked to discrimination against english-speaking regions in the country, i.e., the northwest and southwest regions, became a deteriorating humanitarian emergency. the united nations has noted that the conflict in the northwest and southwest regions has created a humanitarian emergency affecting approximately . million people [ ] . as of august , there were , internally displaced persons in the northwest and southwest regions and , internally displaced persons in the far north region [ ] . for political reasons, the government has repeatedly downplayed the severity of the displacement and the humanitarian need, putting it at odds with aid agencies, including the united nations office in the country. for example, in , the government, through the minister of foreign affairs, said that aid agencies had inflated the number of internally displaced persons in order to receive aid from donors, and noted that only , displaced families have been identified and that the government was already providing humanitarian assistance to , of them [ ] . the government has focused on blocking the delivery of aid to the northwest and southwest regions to show that there is no humanitarian crisis in these regions [ ] , and the government recently suspended flights by aid groups to these regions [ ] . officially, the government claims that this is to prevent the spread of covid- , but the move may have more to do with politics, and seems to be part of a government strategy to restrict aid agencies' access to these regions in order to in turn prevent access to information on the ground and thus impose its narrative. there are confirmed cases in both regions, so by suspending the un humanitarian air service, the government is preventing aid, including medical supplies, from reaching the most vulnerable people. in a news conference, the who's director-general famously said, "do not politicise this virus." it seems that his call was not heeded in cameroon. on april , opposition leader prof. maurice kamto launched the "survie-cameroon-survival initiative" (scsi) in order to raise funds to fight covid- in the country. in response, the country's minister of territorial administration said that any appeal to public generosity, for whatever reason, must be authorized by his ministry, considering the scsi to be "illegal", and ordered banks and mobile phone operators to close accounts linked to scsi. to the government, the launch of scsi was a direct challenge to the solidarity fund set up by the government to fight covid- . on april , a gift of approximately , face masks and test kits from prof. maurice kamto under the banner of scsi was rejected by the minister of public health, and the scsi coordinator was told to take the gift to the ministry of territorial administration [ ] . according to the government, scsi was functioning illegally, as it had not received authorization from the ministry of territorial administration to collect public donations. it is based on this narrative of illegality that the minister of public health said that the gift would have been received if the opposition leader had presented it as an individual and not through scsi, concluding that "just because we are in an epidemic does not mean that we have to set aside our laws and regulations . . . this must be emphasized. we did not refuse to do so [receive the gift], but we simply asked him to get in touch with the ministry of territorial administration which oversees associations" [ ] . based on the aforementioned points, it is clear that some people are not receiving assistance because of politics. on may , six volunteers from scsi were arrested while handing out free protective masks and sanitizing gel to residents of yaoundé, the capital [ ] . some medical facilities are in need of vital supplies, low-income people are in need of masks and hand sanitizer, and communities affected by conflict lack food and other basic necessities, while politicians seem to be focused on scoring political points. this is another manifestation of structural violence. although the focus here has been on cameroon, some of the core issues discussed so far are not unique to the country. corruption is also pervasive in neighbouring countries such as gabon, nigeria, central african republic, chad, republic of congo, and equatorial guinea. according to the corruption perception index, these countries occupied the rd, th, rd, nd, th, and rd positions out of countries, respectively, thus indicating very high levels of corruption [ ] . based on these rankings, these countries are worse off compared to other african countries such as botswana (which ranked ), rwanda (ranked ), and mauritius (ranked ). in comparison, nigeria and chad were the most corrupt countries in and , with rankings of and , respectively [ , ] . similar to cameroon, investment in the public health system has also been limited in neighbouring countries. based on data from the world bank's world development indicators and stockholm international peace research institute (sipri), in chad, for example, while military spending increased when the country started receiving oil revenues in , except for and , there has been a decrease in health expenditures as a percentage of government spending. according to data from the world bank's world development indicators, health expenditures in chad as a percentage of government spending decreased from . % in to . % in , and then to . % in . in the republic of congo, another oil-exporting country, data from the world bank's world development indicators show that since , health expenditures as a percentage of general government expenditure have been below %. unsurprisingly, these countries have weak health care systems. the health system is even worse in the central african republic, which has been ravaged by a protracted civil war. as of april , the un's office for the coordination of humanitarian affairs (ocha) noted that there were only three ventilation kits, one oxygen concentrator, and one covid- treatment centre with beds in that country [ ] . as in cameroon, the pandemic has been politicised in neighbouring countries. the government of equatorial guinea recently expelled the country's who representative based on a claim that the representative had falsified the country's tally of covid- cases [ ] , since figures published by the who have sometimes been higher than those put forward by the country's government. additionally, equatorial guinea's official tally of covid- cases had been being updated daily, but the practice ceased on april [ ] . this case corroborates the point mentioned earlier regarding the political economy of data in african countries. the point emphasised here is that cameroon's economic, social, and political issues are not unique to that country. although there are differences in terms of specifics, there is a general pattern noticeable in cameroon and its neighbour countries, and moreover, covid- has equally exposed the weak health care systems in those countries. the covid- pandemic has exposed weak health systems in several countries, especially those in the global south. medical experts are currently focused on the epidemiology of the disease, and rightly so, due to its high fatality rate, as the disease has so far claimed the lives of over , people. so, scientists are racing to develop a vaccine, and in the meantime governments around the world have implemented restrictive measures aimed at containing the spread of the disease. although these efforts are laudable, i argue that it is important to examine the political economy of covid- , as political and economic forces influence the fight against the disease. using cameroon as a case study, i have examined the economic, political, and social forces that negatively affect the fight against covid- , and argue that the country's weak health care system makes it challenging to tackle the disease there as well as in other countries. a combination of structural adjustment policies in the s and s as well as corruption and limited investment in recent times have severely weakened the country's health system, causing poor and vulnerable populations to suffer the most. additionally, politicians are using the pandemic to score political points, as, for political reasons, the government has prevented aid, including medical supplies, from humanitarian organisations from reaching vulnerable populations in certain regions. based on the foregoing, i contend that the inability to tackle the covid- disease may not always be due to a lack of medical supplies or other forms of assistance. as i have shown, aid is at times available, but some people are not able to access it. put differently, political forces are thwarting the response to covid- in cameroon, so politics must be brought into the discourse. the response to covid- in cameroon is a political process, and strategies produced by various actors in the development community cannot be effective if the complexity of local politics is not taken seriously. it is also worth noting that the pandemic has also brought to the fore the weaknesses of health-systems in western countries, as several countries in the west have also been facing challenges in tackling the pandemic due to years of budget cuts that have weakened their health care systems. the major difference between african countries and western countries is that in most cases, the latter have the capacity to mobilise resources needed by health care systems at short notice, while the former often do not have that capacity. the apc was 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evaluation. financing global health; institute for health metrics and evaluation detained in cameroon's hospitals. available online: www cameroon hospital detains new mothers over unpaid fees Équinoxe tv-journal h du lundi cameroonian president hails china's jack ma over support in fighting covid- united states department of state. the united states is leading the humanitarian and health assistance response to covid- cameroon coronavirus: swiss govt donates $ m, health workers agitate an aid-institutions paradox? a review essay on aid dependency and state building; cgd working paper no. urban agriculture in cameroon: an anti-politics machine in the making? geoforum jump-starting an economic crisis overseas development institute. structural adjustment and sustainable development in cameroon the everyday life of the poor in cameroon: the role of social networks in meeting needs the political economy of cameroon-historical perspectives livelihood strategies of urban residents in africa: the case of residents in bamenda understanding the protest of february in cameroon price hikes blamed on ambiguous government policies. cameroon post are there crisis-led fertility declines? evidence from central cameroun the state of the health workforce in sub-saharan africa: evidence of crisis and analysis of contributing factors cameroon public health sector: shortage and inequalities in geographic distribution of health personnel the health workers crises in cameroon distribution impact of public spending in cameroon: the case of health care the articulation of formal and informal medicine distribution in south cameroon. in the context of medicines in developing countries: studies in pharmaceutical anthropology anthropologie santé , . [crossref] . national institute of statistics. perception de la gouvernance et de l'intégrité au cameroun: une Étude quantitative basée sur les résultats d'enquêtes statistiques auprès des ménages corruption and discrimination in douala metropolis public hospitals of cameroon implementing a transparency and account-ability policy to reduce corruption: the gavi alliance in cameroon cameroon court jails ex-finance minister for years for corruption arrests in cameroon for corruption, or challenges to biya? available online poor numbers: how we are misled by african development statistics and what to do about it africa's statistical tragedy african economic outlook : promoting youth employment; afdb: tunis presentation of the first results of the fourth cameroon household survey (ecam) of water shortages plague major cameroon cities health, wealth and poverty in developing countries: beyond the state, market and civil society why inequality could spread covid- violating covid- restrictions can get you arrested. voa news nearly two million cameroonians face humanitarian emergency: unicef crise anglophone: la guerre des chiffres entre le gourvernement et les ong covid- brings out government's ugly side in cameroon humanitarian response plan covid- equatorial guinea accuses who official of falsifying covid- data acknowledgments: i am grateful to the anonymous reviewers for their constructive feedback and insightful comments as this article gradually came to fruition. the usual disclaimer applies. the authors declare no conflict of interest. key: cord- - khv kbj authors: cohen, jennifer; van der meulen rodgers, yana title: contributing factors to personal protective equipment shortages during the covid- pandemic date: - - journal: prev med doi: . /j.ypmed. . sha: doc_id: cord_uid: khv kbj this study investigates the forces that contributed to severe shortages in personal protective equipment in the us during the covid- crisis. problems from a dysfunctional costing model in hospital operating systems were magnified by a very large demand shock triggered by acute need in healthcare and panicked marketplace behavior that depleted domestic ppe inventories. the lack of appropriate action on the part of the federal government to maintain and distribute domestic inventories, as well as severe disruptions to the ppe global supply chain, amplified the problem. analysis of trade data shows that the us is the world's largest importer of face masks, eye protection, and medical gloves, making it highly vulnerable to disruptions in exports of medical supplies. we conclude that market prices are not appropriate mechanisms for rationing inputs to health because health is a public good. removing the profit motive for purchasing ppe in hospital costing models and pursuing strategic industrial policy to reduce the us dependence on imported ppe will both help to better protect healthcare workers with adequate supplies of ppe. since early the us has experienced a severe shortage of personal protective equipment (ppe) needed by healthcare workers fighting the covid- pandemic (emanuel et al., ; livingston, desai, & berkwits, ) . in protests covered by the news media, healthcare workers compared themselves to firefighters putting out fires without water and soldiers going into combat with cardboard body armor. medical professionals have called for federal government action to mobilize and distribute adequate supplies of protective equipment, especially gloves, medical masks, goggles or face shields, gowns, and n respirators. n respirators, which have demonstrated efficacy in reducing respiratory infections among healthcare workers, have been in particularly short supply (macintyre et al., ) . without proper ppe, healthcare workers are more likely to become ill. a decline in the supply of healthcare due to worker illness combines with intensified demand for care, causing healthcare infrastructure to become unstable, thus reducing the quality and quantity of care. sick healthcare workers also contribute to viral transmission. hence ill practitioners increase the demand for care while simultaneously reducing health system capacity. this endogeneity makes a ppe shortage a systemwide public health problem, rather than solely a worker's rights or occupational health issue. ppe for healthcare workers is a key component of infection prevention and control; ensuring that healthcare workers are protected means more effective containment for all. we investigate the four main contributing factors behind the us shortage of ppe in and their interaction. first, a dysfunctional budgeting model in hospital operating systems incentivizes hospitals to minimize costs rather than maintain adequate inventories of ppe. second, a major demand shock triggered by healthcare system needs as well as panicked j o u r n a l p r e -p r o o f journal pre-proof marketplace behavior depleted ppe inventories. third, the federal government failed to maintain and distribute domestic inventories. finally, major disruptions to the ppe global supply chain caused a sharp reduction in ppe exported to the us, which was already highly dependent on globally-sourced ppe. market and government failures thus led ppe procurement by hospitals, healthcare providers, businesses, individuals, and governments to become competitive and costly in terms of time and money. the remainder of this article provides detailed support for the argument that the enormous ppe shortages arose from the compounding effects of these four factors. we conclude that because health is a public good, markets are not a suitable mechanism for rationing the resources necessary for health, and transformative changes are necessary to better protect healthcare practitioners. the shortage of ppe was an eventuality that nonetheless came as a surprise. the us experienced heightened demand for ppe in the mid-to late- s following the identification of the human immunodeficiency virus and the release of centers for disease control (cdc) guidelines for protecting health personnel (segal, (hersi et al., ) . although various stakeholders (governments, multilateral agencies, health organizations, universities) warned of the possibility of a major infectious disease outbreak, particularly pandemic influenza, most governments were underprepared. the world economic forum's annual global risks report even showed a decline in the likelihood and impact of a spread of infectious diseases as a predicted risk factor between and (wef, (wef, , . the problems created by lack of preparation were exacerbated by the high transmissibility of covid- and the severity of symptoms. contributing to the inadequate stockpiles of ppe were the trump administration's policies -which included public health budget cuts, "streamlining" the pandemic response team, and a trade war with the country's major supplier of ppeweakening the cdc's capacity to prepare for a crisis of this magnitude (devi, ) . the ppe shortage is reflected in survey data on ppe usage and in data on covid- morbidity and mortality. as of may , % of nurses reported having to reuse a single-use disposable mask or n respirator, and % of nurses reported they had been exposed to confirmed covid- patients without wearing appropriate ppe (nnu, ). as of july , , at least , nurses, doctors, physicians assistants, medical technicians, and other healthcare workers globally, and in the us, have died due to the virus, and many more have become sick (medscape, ) . the cdc aggregate national data of , cases among healthcare personnel and deaths (cdc, b). healthcare workers have died from covid- healthcare worker deaths by state recorded in medscape ( ) are correlated with cdc ( b) covid- cases by state (pearson's r of . , p< . ) and even more strongly correlated with cdc-confirmed covid deaths in the general population (pearson's r of . , p< . ). these correlation coefficients are indicative of healthcare worker exposure to the virus, and of the critical role of ppe and healthcare systems for population health. in other words, population health is a function of the healthcare system and wellbeing of healthcare workers, and the wellbeing of healthcare workers is a function of the healthcare system and ppe. we now turn to our analysis of ppe shortages, which identifies on four contributing factors: the way that hospitals budget for ppe, domestic demand shocks, federal government failures, and disruptions to the global supply chain (figure ). these four factors arose from a number of processes and worked concurrently to generate severe shortages. the first factor the budgeting model used by hospitals is a structural weakness in the healthcare system. the occupational safety and health administration (osha) requires employers to provide healthcare workers with ppe free of charge (barniv, danvers, & healy, ; osha, ) . from the perspective of employers, ppe is an expenditurea cost. ppe is unique compared to all of the other items used to treat patients (such as catheters, bed pans, and medications) which operate on a cost-passing model, meaning they are billed to the patient/insurer. an ideal model for budgeting ppe would align the interests of employers, healthcare workers, and patients and facilitate effective, efficient care that is safe for all. instead, the existing structure puts employers who prioritize minimizing costs and healthcare workers who prioritize protecting their safety and the health of their patients in opposition, leaving governmental bodies to regulate these competing priorities (moses et al., ) . employers, be they privately-owned enterprises, private healthcare clinics, or public hospitals, seek to minimize costs. in economic theory, cost-minimization is compelled through market competition with other suppliers. in practice, cost-minimization is a strategy for maintaining profitability or revenue. therefore, hospital managers adopt cost-effective behaviors by reducing expenditures in the short term to lower costs (mclellan, ) . despite some hospitals' tax-exempt status, hospitals function like other businesses: they pursue efficiency and cost minimization (bai & anderson, ; rosenbaum, kindig, bao, byrnes, & o'laughlin, ) . the pursuit of efficiency means hospitals tend to rely on just-in-time production so that they do not need to maintain ppe inventories. the osha requirement effectively acts as an unfunded mandate, imposing responsibility for the provision of ppe, and the costs of provision, on employers. when it is difficult to pass along the costs of unfunded mandates to workers (in the form of lower wages) or customers (in the form of higher prices), employers resist such cost-raising legal requirements. the tension between healthcare workers and employers over ppe is evident in the way nurses' unions push federal and state agencies to establish protective standards. it is demonstrated by the testimony of the co-president of national nurses united to the committee on oversight and government reform in the us house of representatives in october . she advocated for mandated standards for ppe during the ebola virus while employers were pushing for voluntary guidelines: [o]ur long experience with us hospitals is that they will not act on their own to secure the highest standards of protection without a specific directive from our federal authorities in the form of an act of congress or an executive order from the white house…the lack of mandates in favor of shifting guidelines from multiple agencies, and reliance on voluntary compliance, has left nurses and other caregivers uncertain, severely unprepared and vulnerable to infection (govinfo, ). employer resistance is short-sighted but unsurprising in the existing costing structure. the costing structure for other items, like catheters, allows employers to pass costs on to patients and insurers. the implication is that if employers (hospitals) cannot pass along the cost of the osha mandate to insurance companies, then employers do not have an economic incentive to encourage employees to use ppe, replace it frequently, or keep much of it in stock, at least until any gains from cost-minimization are lost due to illness among employees. the budgeting model is especially problematic when demand increases sharply, such as during the ebola virus in and the h n influenza pandemic in . as the site where new pathogens may be introduced unexpectedly, hospitals are uniquely challenged compared to other employers to provide protection (yarbrough et al., ) . but even during predictable fluctuations in demand, the existing model does not ensure that adequate quantities of ppe are available. however, previous studies have framed these problems as consequences of noncompliance among healthcare workers rather than noncompliance among employers (ganczak & szych, ; gershon et al., ; nichol et al., ; sax et al., ) . hospitals might be incentivized to avoid shortages by passing ppe costs on to patients and insurers, like other items used in care, but that approach is not the norm. this alternative cost-passing model also leaves much to be desired. where the current model induces tension between workers and employers, a cost-passing model would effectively situate practitioners against patients (cerminara, ) . if patients pay the costs of ppe, they might prefer that practitioners are less safe to defray costs. such a model is detrimental to both healthcare workers and patients. introducing tension to a relationship built on care and trust is precisely why the employer, not the patient, should be required to provide ppe to healthcare workers at no cost to j o u r n a l p r e -p r o o f journal pre-proof the worker. practitioners and patients should be allowed to share the common goal of improving patients' well-being. some labor economists argue that employers could (or do) pay compensating wage differentials to compensate healthcare workers for working in unsafe conditions (hall & jones, ; rosen, ; viscusi, ) . they believe that workers subject to hazardous conditions command a higher wage from employers compared to workers in less dangerous employment. higher wages for healthcare workers would then be embedded in the costs of care, which include pay for practitioners, that are passed along to insurance companies. however, this counterargument does not apply to healthcare practitioners because its necessary conditions are not met. workers would need perfect foresight that a crisis would require more protective equipment, knowledge of their employers' stockpile of ppe, perfect information about the hazards of the disease, and how much higher a wage they would need as compensation for these risks. this information is not available for workers who may be exposed to entirely novel pathogens that have unknowable impacts. neither the existing budgeting model nor the cost-passing model align the interests of the employer, healthcare worker, and patient. yet these three agents have a shared interest in practitioners' use of ppe. ppe, like catheters, are inputs to health. but unlike catheters, the primary beneficiary of ppe use is less easily identifiable than that of other inputs. while healthcare practitioners may appear to be the primary beneficiaries of ppe, the benefits are more diffuse. patients benefit from having healthy nurses who are not spreading infections, nurses benefit from their own health, and hospitals benefit from have a healthy workforce. nurses' health is an input to patient health, to the functioning of the hospital, and to the healthcare system. in other words, every beneficiary depends on nurses' health, which depends on ppe. still, employers' short-term profit motive dominates the interests of healthcare workers and patients, which suggests that alternative models that are not motivated by profit-seeking should be explored. the second contributing factor to the us shortage of ppe during the covid- outbreak was the rapid increase in demand by the healthcare system and the general public. in a national survey of hospital professionals in late march close to one-third of hospitals had almost no more face masks and % had run out of plastic face shields, with hospitals using a number of strategies to try to meet their demand including purchasing in the market and soliciting donations (kamerow, ) . american consumers also bought large supplies of ppe as the sheer scale of the crisis and the severity of the disease prompted a surge in panic buying, hoarding, and resales of masks and gloves. as an indicator of scale, in march amazon cancelled more than half a million offers to sell masks at inflated prices and closed , accounts for violating fair pricing policies (cabral & xu, ) . panicked buying contributed to a sudden and sharp reduction in american ppe inventories, which were already inadequate to meet demand from the healthcare system. there were two different kinds of non-healthcare buyers of ppe. a subset sought profits and bought and hoarded ppe items such as n respirators with the intent of reselling them at inflated prices (cohen, forthcoming) . it is likely that the majority, however, were worried consumers. while it may be tempting to blame consumers for seemingly irrational consumption, their decisions are more complex. panic buyers are consumers in the moment of buying ppe, but they are workers as well; people buy ppe because they are afraid of losing the ability to work j o u r n a l p r e -p r o o f and support themselves and their families. put simply, the dependence of workers on wages to pay for basic necessities contributes to panic when their incomes are threatened. this is rational behavior in the short term given existing conditions and economic structures. still, ppe belongs in the hands of those whose health has many beneficiaries: practitioners. eventually both the profiteer and the average, panicked worker/consumer will require healthcare, and contributing to the decimation of the healthcare work force is in no one's interest. underlying consumption behavior was intense fear of not only the disease but also fear of shortages. this panic reverberated throughout the supply chain as manufacturers tried to increase their production capacity to meet the demand for ppe (mason & friese, ) . one can conceptualize this mismatch between ppe demand and supply in an ability-topay framework. in much of economic theory, markets match supply and demand to determine the price of a good or service, and the price operates as a rationing mechanism. market actors choose to buy or sell at that given price. but there are problems with this framework. on the demand side, some people cannot "choose" to buy a product because they cannot afford it; they lack the ability to pay, so the decision is made for them. an example is a potential trip to the doctor for the uninsured. for many americans, whether to go to the doctor, or whether to have insurance, is not a choice; the choice is made for them because they are unable to pay. on the supply side, the ability-to-pay framework remains, except the product in question is an input. in healthcare, the practitioner is the proximate supplier of care and inputs to health are intermediate goods. the supplier's -or their employer'sability (and willingness) to pay for inputs to care, including ppe, determines the quality and quantity of care the practitioner is able to supply. when healthcare workers do not have ppe (e.g. because others bought it and resold it at extortionary prices), they are unable to provide the care patients need. but reselling behavior is j o u r n a l p r e -p r o o f also economically rational, if unethical, at least in the short term. indeed, ability-to-pay works well for the hoarder/reseller, who both contributes to and profits from the shortage. it is in the pursuit of profitsof monetary gainthat the mismatch between ppe demand and supply resides. on the demand side there is a person in need of care who is constrained by their inability to pay, while on the supply side there is a practitioner who is constrained by their inability to access the resources required to provide high quality care safely. the ability-to-pay framework is incompatible with the optimal allocation of resources when the ultimate aim is something other than monetary gain. hence market prices are not a good mechanism for rationing vital inputs to health such as ppe, and the profit motive is ineffective in resolving this mismatch between demand and supply. given the large-scale failure of the market to ensure sufficient supplies of ppe for practitioners, the government could have taken a number of corrective actions: it could have coordinated domestic production and distribution, deployed supplies from the strategic national stockpile, or procured ppe directly from international suppliers (hhs, ; maloney, ). the us government has anticipated ppe shortages since at least when the national institute for occupational safety and health commissioned a report examining the lack of preparedness of the healthcare system for supplying workers with adequate ppe in the event of pandemic influenza (liverman & goldfrank, ) . in a scenario in which % of the us population becomes ill in pandemic influenza, the estimated need for n respirators is . billion (carias et al., ) . however, the actual supply in the us stockpile was far smaller at j o u r n a l p r e -p r o o f million, thus serving as a strong rationale to invoke the defense production act to manufacture n respirators and other ppe (azar, ; friese et al., ; kamerow, ) . further, the ppe in the national stockpile was not maintained on a timely basis to prevent product expiration, forcing the cdc to recommend use of expired n s (cdc, a). adding to the problems of cdc budget cuts before and during the pandemic and their failure to stockpile ppe was the unwillingness of the federal government to invoke the defense production act to require private companies to manufacture ppe, ventilators, and other critical items needed to treat patients (devi, ) . by july , at which time the us already had more covid- cases than any other country in the world, there were still calls from top congressional leaders and healthcare professionals, including the speaker of the house of representatives and the president of the american medical association, for the trump administration to use the defense production act to boost domestic production of ppe (madara, ; pelosi, ; j. rosen, ) . researchers had also begun to publish studies on how to safely re-use ppe as it became clear that shortages would continue (rowan & laffey, ) . hence even five months into the crisis, the profit motive was still inadequate to attract new producers, which indicates that markets do not work to solve production and distribution problems in the case of inputs to health. not only did the government poorly maintain already-inadequate supplies and fail to raise production directly, it also failed to provide guidance requested by private sector medical equipment distributors and the health industry distributors association (hida), a trade group of member companies (maloney, ) . the private sector sought guidance about accessing government inventories, expediting ppe imports, and how to prioritize distribution, as indicated in this communication from hida's president: specifically, distributors need fema and the federal government to designate specific localities, jurisdictions or care settings as priorities for ppe and other medical supplies. the private sector is not in a position to make these judgments. only the federal government has the data and the authority to provide this strategic direction to the supply chain and the healthcare system (m. . moreover, it was not until early april that the trump administration issued an executive order for m, one of the largest american producers and exporters of n respirators, to stop exporting masks and to redirect them to the us market (whitehouse.gov, ) . looking up the supply chain, at least one distributor proposed bringing efforts to procure ppe internationally under a federal umbrella to the trump administration (maloney, , p. ). states-as-buyers confront the same market-incentivized structural issues that individual buyers face. a single federal purchaser would reduce state-level competition for buying ppe abroad, and mitigate the resulting inflated prices and price gouging by brokers acting as intermediaries between states-as-buyers and suppliers. the federal government chose not to take on this role. the profound government failures related to producing, procuring, and distributing ppe effectively, in ways not achievable through markets, are likely to have long-term impacts. the same distribution companies characterized, "the economics of supplying ppe in these circumstances" as "not sustainable" (maloney, , p. ) . they also expressed concern about the ongoing availability of raw materials required to manufacture ppe in the future. hida member companies expressed these concerns about supply chain issues in calls with federal agencies between january and march , specifically with respect to long-term supply chain issues impacting the upcoming - flu season (maloney, , p. ) . in mid-june, fema officials acknowledged that, "the supply chain is still not stable" (maloney, , p. ). a smoothly functioning supply chain has immediate impacts on the ability of governments and health personnel to contain an epidemic. the infectiousness and virulence of the disease affects the demand for ppe, just as the supply chain's functionality impacts the spread of the disease by improving practitioners' ability to treat their patients while remaining safe themselves (gooding, ) . the us domestic supply chain of ppe has been unable to sufficiently increase production to meet the enormous surge in demand. a large portion of the ppe in the us is produced in other countries. excessive reliance on off-shore producers for ppe proved problematic in earlier public health emergencies (especially the h n influenza pandemic and the ebola virus epidemic), and this lesson appears to be repeating itself during the covid- pandemic (patel et al., ) . the incentive for hospitals and care providers to keep costs down has kept inventories low and driven sourcing to low-cost producers, especially in china. china's low production costs combined with high quality have made it the global leader in producing a vast range of manufactured goods, including protective face masks, gloves, and gowns. even with the emergence of other low-cost exporters, china dominates the global market for ppe exports. meanwhile, the us is the world's largest importer of ppe. yet although the us is extremely dependent on the global supply chain, us manufacturers of ppe are also major exporters given the profits available in world markets. the trade data in table show the world's four top exporters of face masks, eye protection, and medical gloves. the data is drawn from the un comtrade database, using trade classifications from the who's world customs organization for covid- medical supplies j o u r n a l p r e -p r o o f (who, ) . in these data, the category "face masks" includes textile face masks with and without a replaceable filter or mechanical parts (surgical masks, disposable face-masks, and n respirators); "eye protection" includes protective spectacles and goggles as well as plastic face shields; and "medical gloves" includes gloves of different materials such as rubber, cloth, and plastic (who, ). we collected data for the - period. because patterns in - were very similar to those of , the china is the world's largest exporter of medical face masks and eye protection, followed not far behind by the us. the fact that the us recently exported such large amounts of a commodity that in early was marked by extreme shortages is indicative of the lack of public health planning and political will. unlike the case of masks and eye protection, the us is not a top exporter of medical gloves. the three largest exporters of medical gloves are all in asia and are well endowed with natural rubber. table also shows that the us is by far the largest importer of face masks, eye equipment, and medical gloves in the world market, followed by japan, germany, france, and the uk. overall, this analysis points to the high vulnerability of the us to disruptions in the global supply chain of face masks, eye protection, and medical gloves, and especially to disruptions in exports from china. the covid- outbreak in china in late led to a surge in demand within china for ppe, especially for disposable surgical masks as the government required anyone leaving their home to wear a mask. in response to demand, china's government not only restricted its ppe exports, it also purchased a substantial portion of the global supply (burki, ) . these shocks contributed to an enormous disruption to the global supply chain of ppe. as the virus spread to other countries, their demand for ppe also increased and resulted in additional pressure on dwindling supplies. in response, other global producers of ppe, including india, taiwan, germany, and france, also restricted exports. by march , numerous governments around the world had placed export restrictions on ppe, which in turn contributed to higher costs. the price of surgical masks rose by a factor of six, n respirators by three, and surgical gowns by two (burki, overall then, with respect to imports, the us is the biggest importer and so is highly dependent on the global supply chain, and with respect to exports, the us failed to prioritize the country's public health needs. after the covid- outbreak, the us was late to restrict ppe exports as other countries did, and the government failed to take the opportunity to order millions of masks in the years leading up to covid- crisis, including the two-month period between when the virus was recognized in china and when local transmission was detected in the us. impacts. hence the seemingly gender-neutral costing model described in our analysis does not have gender-neutral outcomes. by implication, a meaningful change in the way healthcare is funded that incentivizes hospitals to invest in adequate inventories of ppe will disproportionately benefit women workers. the gender differential is even more striking in the case of home-health aides. more research is needed on the extent to which men and women are impacted differently by ppe shortages. another important question is the extent to which gender issuessuch as women's relative lack of bargaining power in hospital administrationcontributed to shortages to begin with. our analysis points to the need for transformative changes and corrective actions to better protect healthcare practitioners. we must consider a full range of tools that not only create incentives for hospitals to protect their care providers with ppe, but also generate effective institutional capacity to ensure that health providers can mobilize quickly to handle pandemics. we have several recommendations: ( ) prepare hospitals to better protect practitioners by removing the profit motive from consideration in the purchasing and maintenance of ppe inventories; ( ) strengthen the capacity of local, state, and federal government to maintain and distribute stockpiles; ( ) improve enforcement of osha's current regulations around ppe, including requirements to source the proper size for each employee; ( ) develop new regulations to reduce practitioner stress and fatigue (cohen & venter, ; fairfax, ) ; ( ) improve the federal government's ability to coordinate supply and distribution across hospitals and local and state governments (patel et al., ) ; ( ) consider strategic industrial policy to increase us production of medical supplies and to reduce the dependence on the global supply chain for ppe; ( ) consider industrial policy to incentivize ppe production using existing technology while encouraging development, testing, and production of higher-quality, reusable ppe. these changes will address the costing-model issue, the demand problem, the federal government failures, and supply chain vulnerability, but they will not be politically palatable. creating the institutional capacity for building and maintaining a viable stockpile of ppe will j o u r n a l p r e -p r o o f contribute to all of these policy options. such shifts will help set the stage for what global health should look like moving forward. covid- was not the first pandemic nor will it be the last, especially given the likely impacts of climate change. congressional testimony: health and human services fiscal year budget request. c-span a more detailed understanding of factors associated with hospital profitability the impact of medicare capital prospective payment regulation on hospital capital expenditures global shortage of personal protective equipment. the lancet infectious diseases seller reputation and price gouging: evidence from the covid- pandemic potential demand for respirators and surgical masks during a hypothetical influenza pandemic in the united states considerations for release of stockpiled n s beyond the manufacturer-designated shelf life contextualizing adr in managed care: a proposal aimed at easing tensions and resolving conflict covid- capitalism: the profit motive versus public health the integration of occupational-and household-based chronic stress among south african women employed as public hospital nurses invisible women: data bias in a world designed for men u.s.-china tariff actions by the numbers us public health budget cuts in the face of covid- fair allocation of scarce medical resources in the time of covid- the occupational safety and health administration's impact on employers: what worked and where to go from here respiratory protection considerations for healthcare workers during the covid- pandemic surgical nurses and compliance with personal protective equipment hospital safety climate and its relationship with safe work practices and workplace exposure incidents a mixed methods approach to modeling personal protective equipment supply chains for infectious disease outbreak response the value of life and the rise in health spending* effectiveness of personal protective equipment for healthcare workers caring for patients with filovirus disease: a rapid review strategic national stockpile. public health emergency covid- : the crisis of personal protective equipment in the us preparing for an influenza pandemic: personal protective equipment for healthcare workers sourcing personal protective equipment during the covid- pandemic efficacy of face masks and respirators in preventing upper respiratory tract bacterial colonization and co-infection in hospital healthcare workers letter from american medical association to vice president michael pence memorandum: information provided by medical distribution companies on challenges with white house supply chain task force and project airbridge protecting health care workers against covid- -and being prepared for future pandemics work, health, and worker well-being: roles and opportunities for employers in memoriam: healthcare workers who have died of covid- the anatomy of health care in the united states behind the mask: determinants of nurse's adherence to facial protective equipment new survey of nurses provides frontline proof of widespread employer, government disregard for nurse and patient safety, mainly through lack of optimal ppe employer payment for personal protective equipment; final rule personal protective equipment supply chain: lessons learned from recent public health emergency responses transcript of pelosi interview on cnbc's mad money with jim cramer/interviewer rosen, homeland security committee colleagues demand answers from administration on strategic national stockpile letter from health industry distributors association the theory of equalizing differences. handbook of labor economics the value of the nonprofit hospital tax exemption was $ . billion in challenges and solutions for addressing critical shortage of supply chain for personal and protective equipment (ppe) arising from coronavirus disease (covid ) pandemic -case study from the republic of ireland knowledge of standard and isolation precautions in a large teaching hospital the role of personal protective equipment in infection prevention history the value of risks to life and health global risks report global risks report memorandum on order under the defense production act regarding m company respirator use in a hospital setting: establishing surveillance metrics acknowledgements: the authors thank jacquelyn baugher, rn, bsn, ocn, for providing insight that aided our understanding of occupational relations internal to hospitals. key: cord- - xjmv authors: aravena, j. m.; aceituno, c.; nyhan, k.; shi, k.; vermund, s.; levy, b. r. title: 'drawing on wisdom to cope with adversity:' a systematic review protocol of older adults' mental and psychosocial health during acute respiratory disease propagated-type epidemics and pandemics (covid- , sars-cov, mers, and influenza). date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: xjmv background: mental health has become one of the fundamental priorities during the covid- pandemic. situations like physical distancing as well as being constantly tagged as the most vulnerable group could expose older adults to mental and psychosocial burdens. nonetheless, there is little clarity about the impact of the covid- pandemic or similar pandemics in the past on the mental illness, wellbeing, and psychosocial health of the older population compared to other age groups. objectives: to describe the patterns of older adults' mental and psychosocial health related to acute respiratory disease propagated-type epidemics and pandemics and to evaluate the differences with how other age groups respond. eligibility criteria: quantitative and qualitative studies evaluating mental illness, wellbeing, or psychosocial health outcomes associated with respiratory propagated epidemics and pandemics exposure or periods (covid- , sars-cov, mers, and influenza) in people years or older. data source: original articles published until june st, , in any language searched in the electronic healthcare and social sciences database: medline, embase, cinahl, psycinfo, scopus, who global literature on coronavirus disease database, china national knowledge infrastructure ( - cnki). furthermore, eppi centre's covid- living systematic map and the publicly available publication list of the covid- living systematic review will be incorporated for preprints and recent covid- publications. data extraction: two independent reviewers will extract predefined parameters. the risk of bias will be assessed. data synthesis: data synthesis will be performed according to study type and design, type of epidemic and pandemic, types of outcomes (mental health and psychosocial outcomes), and participant characteristics (e.g., sex, race, age, socioeconomic status, food security, presence of dependency in daily life activities independent/dependent older adults). comparison between sex, race, and other age groups will be performed qualitatively, and quantitatively if enough data is available. the risk of bias and study heterogeneity will be reported for quantitative studies. conclusion: this study will provide information to take actions to address potential mental health difficulties during the covid- pandemic in older adults and to understand responses on this age group. furthermore, it will be useful to identify potential groups that are more vulnerable or resilient to the mental-health challenges of the current worldwide pandemic. according to the world health organization (who), mental health is defined as "a state of well-being in which the individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community". this definition considers several aspects of wellbeing and psychosocial health that are fundamental to maintain an optimal state of health. on the other hand, a relevant part of mental health acknowledges the influence of mental illness in the life of people. mental illness is described by the american psychiatric association (apa) as "health conditions involving changes in emotion, thinking or behavior (or a combination of these). mental illnesses are associated with distress and/or problems functioning in social, work, or family activities." under both definitions, mental health will be influenced by psychosocial situations as well as mental illness. the presence of harmful psychosocial exposures (e.g., loneliness, stigma, social isolation) and an increase in mental illness can be triggered by exposure to natural disasters that affect populational health such as epidemics and pandemics. the recent sars-cov- virus (covid- ) outbreak has meant a major threat to the worldwide population in several aspects of health, including mental health and psychosocial health, being an emerging significant challenge and research priority for the global population. a good point of comparison to understand covid- present and future mental-health consequences are the past and present experiences observed during epidemics and pandemics outbreaks of similar characteristics. experiences observed in other acute respiratory infections-propagated epidemics and pandemics like sars-cov, mers, and influenza, have left us a precedent of information regarding its substantial impact on people's mental health. situations such as physical distance as one of the most critical measures, uncontrolled exposure to media news about the virus, spread biased or false information, quarantine, isolation, economic hardships, loss of love ones, health consequences, burden, stigma, fear, and anxiety; consequences that have been observed in the present and passed epidemic and pandemic scenarios. - therefore, these experiences must be carefully considered to generate an early response at an individual and populational level, and to anticipate prospective mental health scenarios. in that regard, recently rogers and cols have observed through a systematic review and meta-analysis of psychiatric and neuropsychiatric consequences associated with coronaviruses infections that among patients with severe sars or mers coronavirus infections, delirium, post-traumatic stress disorder, depression, anxiety, and fatigue are common. moreover, in some preliminary data, covid- would present delirium as well as confusion, agitation, depressive symptoms, anxiety, and insomnia. this study set an important precedent about how impactful the coronavirus infection in mental health could be. although, the study did not include the contextual impact of epidemic and pandemics, the full range of psychosocial and wellbeing aspects, and did not compare the mental health among different ages. areas that must be analyzed to understand the full range of influences in mental health and experiences across age groups. a group that could be highly affected are those who have been categorized as high-risk to present severe symptoms or mortality related to the virus such as people with chronic diseases and groups of older adults. covid- pandemic has demonstrated to be a critical challenge for older people's physical health. people years or older are the population with the highest risk of mortality associated with covid- worldwide. patients with multimorbidity and cardiovascular risk, which increase exponentially after years old, are particularly prone to manifest severe symptoms. [ ] [ ] [ ] thus, many communities have suggested or enforced particularly strict prevention measures for older persons with these characteristics. mental health burden could be an associated consequence of being the population at the highest risk and the exposure to strict social isolation in a pandemic. covid- virus and its preventive methods imply important mental health challenges for older people and caregiver's health that must be addressed on time. the classification of "population of high-risk" or in need of shielding could be a source of stress and stigma for older adults, incrementing its social isolation and mental illness symptoms such as anxiety or depression. , mental health burden is particularly harmful to older adults with some degree of dependence in daily life activities or multimorbidity because they manifest a higher risk to experience increased physical frailty and worsening of other diseases. [ ] [ ] [ ] [ ] [ ] if mental illness symptoms and psychosocial difficulties increase in the frail and geriatric older adult' populations during a pandemic period, the rise of dependency, chronic diseases, and emergency visits for causes other than covid- would be an enormous collateral impact of the current worldwide pandemic. diverse and often underlooked realities of aging constitute older adulthood, from independent older adults who have not stopped their work activity, caregivers of family members (e.g., other older adults, grandchildren), older people living on their own, or heads of household, to older persons who require the support of a third person, or others who live in long-term care institutions. in this context, older adults' mental health during natural disasters is controversial. some studies about resilience in other contexts have shown that older adults tend to report a higher resilience and more positive outcome than other age groups, , and others have estimated that older adults are . and . more likely to experience ptsd and adjustment disorder symptoms after natural disasters compared to younger adults, respectively. nevertheless, under normal circumstances, the evidence has shown that older people then to manifest greater levels of wellbeing, lower levels of negative affects, and less distress during their social interactions than other age groups. furthermore, studies have evidenced that older adults are more prone to put attention to positive stimulus than negative ones compared to younger people that present opposite patterns, putting more focus on negative situations. , this talks about certain ability to allocate emotional resources that could be fundamental to cope in a more positive manner with unpredictable or emotionally demanding events. despite all of these, there has not yet been a systematic evaluation to understand these patterns in the context of epidemics or pandemics. therefore, although older adults have been constantly classified as a vulnerable population for covid- , there exists uncertainty about how older adults, compared to other age groups, could respond to a situation that requires an important mental endurance like an epidemic or pandemic. published and ongoing studies, such as roger et al, who have characterized the mental illness and neuropsychiatric consequences associated to coronavirus infections in the general population, and qin and cols who have registered a protocol for a meta-analysis of the impact of covid- on the mental wellbeing of elderly population, have focused their reviews just on clinical outcomes related to mental health. in this context, and considering the increasing number of covid- related articles, a systematic review targeted to older people mental health considering a full-range of neuropsychiatric, psychiatric, psychosocial, and wellbeing parameters associated with the infection or the contextual impacts related to acute respiratory disease propagated-type epidemics and pandemics, contrasting the results among groups seems pertinent and necessary to fully understand the response and experiences of older adults and other age groups in the context of pandemics. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . to comprehend what could be the potential mental health impact associated with respiratory propagated epidemics and pandemics in older adults, and to evaluate the contrast among different age groups it is critical information for the development and planning of policies and programs to address these consequences early and to understand intergenerational differences and similarities in the mental health response to epidemic and pandemics. at the same time, it is fundamental information for the development of interventions and the implementation of policies targeted to change or promote behaviors related to compliance of nonpharmacological measures to prevent the spread of acute respiratory diseases during the context of epidemics and pandemics. considering this background, the main goal of this review is to describe the patterns of older adults' mental health related to acute respiratory disease propagated-type epidemics and pandemics. specifically, this systematic review aims ) to describe the associations between respiratory propagated epidemic and pandemics and older adult's mental health, ) to describe the differences between older adults and other age groups in the effects of mental health factors related to acute respiratory disease propagated-type epidemics and pandemics periods in the mental health, ) to assess the effect of interventions in the older adult's mental health associated to respiratory propagated epidemic and pandemics, and ) to consider moderators of the impact of pandemics on older adults' mental health. the report of the study will follow the prisma statement for reporting systematic reviews and metaanalyses guidelines. we will select studies that: ) describe the effects of acute respiratory disease propagated-type epidemics or pandemics on mental health or psychosocial parameters, and ) include older adults in the sample. quantitative, qualitative, and mixed-method studies will be included in order to consider different aspects of mental health and psychosocial impact. any study evaluating people years or older residing in any setting. research involving people from other age groups (e.g. children, adolescents, adults) additionally to people years or older will be included for analysis. for this review, studies conducted evaluating the impact on mental health during defined acute respiratory disease propagated-type epidemic or pandemic according to the infection prevention and control of epidemic-and pandemic prone acute respiratory infections in health care: who guidelines. : sars coronavirus (sars-cov), middle east respiratory syndrome (mers), and influenza/flu (h n , h n ). sars coronavirus (sars-cov- or covid- ) will be also included. these viruses are selected because they share similar epidemiological characteristics, where its pathogens can cause large scale outbreaks with high morbidity and mortality. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint for the purpose of this review, any study describing outcomes associated with mental health parameters in older adults will be included. mental health will be understood under the who definition: "a state of well-being in which the individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community." for practical operationalization, it will be divided into two main components: mental illness and psychosocial health/wellbeing. examples of mental illness parameters are depression, anxiety, and mood disorders, including intervention studies. studies analyzing parameters such as cognition, dementia, and delirium would be incorporated under the umbrella of mental illness aspects because people with these diagnoses frequently manifest neuropsychiatric symptoms. examples of psychosocial health/wellbeing factors are quality of life, stigma, isolation, and loneliness. studies evaluating the mental illness and psychosocial health/wellbeing parameters of caregivers of older adults will be incorporated. original articles published until june st, , in any language searched in the electronic healthcare and social sciences databases: medline (ovid), embase (ovid), cinahl (ebsco), psycinfo (ovid), scopus, who global literature on coronavirus disease database, china national knowledge infrastructure (中国知网 -cnki). because of limitations in database coverage and indexing speed, covid- related articles will be identified in two other ways. first, studies in the eppi centre covid- living systematic map of the evidence screening review which are tagged with "health impacts," "social/economic impact," or "mental health impacts" will be added to the screening workflow. the eppi centre covid- map consists of studies on covid- , identified in medline and embase, and published in or later. second, for better coverage of preprints, we will use the publicly available publication list of the covid- living systematic review , which retrieves articles from the preprints databases biorxiv and medrxiv and it is continuously updated. because more covid- related articles are published week by week, after the title-abstract screening is completed, another search exclusively for covid- related-articles will be performed in order to include manuscripts that potentially were published or indexed after the date of the first round of database searches. articles included from this second covid- related-articles extraction will be screened in the same fashion as the other studies. an example of the medline search strategy and a search source scheme are described in the supplement section. the search will be adjusted for appropriate controlled vocabulary and syntax in each database. in each database, the search has three elements: queries for the exposure of interest (covid- or other respiratory-propagated pandemics), the outcomes of interest (mental health), and the population of interest (older adults). controlled vocabulary and indexing status will be used, where possible, to maximize the retrieval of papers dealing with the older adult population and to minimize the burden of screening papers about other age groups. no specifications about the type of study are included in the search strategy to reduce the risk of missing studies. mental illness terms were included following the dsm-v and the cochrane common mental disorders group search strategies (https://cmd.cochrane.org/). some psychosocial health/wellbeing terms . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint were incorporated from other systematic reviews about psychosocial health and wellbeing and based on expert opinion. , because an important part of the epidemics and pandemics of these viruses has been experienced in the chinese population, culturally sensible terms to describe mental illness ('impulsive personality disorder,' 'qigong-induced disorders,' 'traveling psychosis,' 'shenjing shuairuo,' and 'neurasthenia') and psychosocial health/wellbeing conditions ('shame,' 'humiliation,' 'low spirits,' 'witchcraft,' 'curses,' 'zou huo ru mo -走火入魔-or qigong deviation -氣功偏差-') were included. , studies will be divided into two main categories for its analysis: ) studies describing the direct effect of virus infection on mental health outcomes, and ) studies illustrating mental health impact associated with the contextual situation of the epidemic or pandemic (e.g. quarantines, social distancing, isolation). the results from all the database searches will be collated in endnote and deduplicated by the cushing/whitney medical library cross-departmental team. the deduplicated results will be uploaded to covidence, an online platform for evidence synthesis. reviewers (ja and ca) will screen articles at the title abstract level, discarding only those articles which are evidently off-target. the full-text screening will also take place in covidence. two independent screeners will vote on each article; disagreements will be solved by consensus or third-party adjudication (bl). articles in english and spanish language will be manipulated by two reviewers (ja and ca). articles in other languages will be handled by two research members (ks and sv). two independent reviewers will perform data extraction using a prespecified data abstraction form designed for this study. the data abstraction form will be pilot-tested on five randomly-selected studies and refined accordingly. data extraction will include characteristics of the study (e.g. country, data source, data collection date, year), methods (e.g. study design, sample characteristics, outcome measurement), and results. extracted studies will be tagged according to the type of outcome they are describing: a) virus infection mental health-related outcomes, b) epidemic or pandemic context mental health-related outcomes, or c) both types of outcomes. data will be entered in a duplicated google questionnaire specifically designed for the study. every researcher will enter the data on independent questionnaires. qualitative and mixed-method studies will be described. quantitative studies will be included for assessment of the risk of bias. two reviewers will independently assess the internal validity of each included quantitative study. study risk of bias will be categorized as low risk of bias, some concerns of bias, and high risk of bias. in the case of observational studies, bias will be evaluated following the next standards: ) ttype of study design, ) temporality of the evaluation of the exposure: concordance in the evaluation timing of the impact of the epidemic/pandemic episode with the study goals, ) outcome evaluation: evaluation of the outcome with standardized and defined measurement instrument or methods, ) adjusted analysis: the . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . inclusion of an adjusted analysis of the main outcome considering relevant variables. for this review, analyses adjusting for age, sex, and pre-existing medical conditions or functional performance will be considered acceptable. ) attrition bias: for cohort studies, % of loss of follow-up will be considered as acceptable. for intervention studies evaluating efficacy or effectiveness in one or more mental health and psychosocial health as a primary outcome, the criteria to evaluate the risk of bias will be: ) type of study design, ) bias arising from the randomization process, ) bias due to deviations from intended interventions, ) bias due to missing outcome data, ) bias in measurement of the outcome, and ) bias in selection of the reported result. studies incorporating mental health parameters as secondary outcomes will be included for description yet will be considered at a high risk of bias. observational study's risk of bias was designed considering strobe and the ahrq methods guidelines. , intervention study risk of bias follows the cochrane handbook for systematic reviews. in the case of quantitative studies, for the continuous variables related to mental health, because of the variety of scores and outcomes produced by the diverse measurement scales, measures such as frequency and prevalence of symptoms and diagnosis (%) or adjusted prevalence, mean and standard deviation (sd) of total scores will be used. in comparison studies, mean differences (md), proportions (%), standardized mean differences (smd), b coefficient, and standardized error, with % confidence intervals (ci) for continuous outcomes will be included. dichotomous outcomes such as adjusted risk ratios (rr), odds ratio (or), and hazard ratio (hr) with % cis will be considered. unadjusted and adjusted results will be extracted. these measures will be extracted for people years older, other age groups described in every article, sex, and race if it is included. for treatment, in the case of cluster randomized trials or interventions delivered in groups, the unit of analysis will be the cluster. for interventions including individuals, the unit of analysis will be the subjects. in the case of rcts, we will seek data irrespective of compliance, in order to allow the intention to treat analysis. for cohort studies, we will make a qualitative evaluation of every study to identify if the missed data lead to a bias in the result. we will judge heterogeneity among studies (the type of study design, inclusion criteria, type of exposure/intervention, outcome measurement) during the qualitative synthesis of the data. additionally, statistical heterogeneity was evaluated using the i statistics, classifying no heterogeneity (< %), low ( - %), moderate ( - %), and high heterogeneity (equal or > %). we will decide on the appropriateness of conducting a meta-analysis based on qualitative and quantitative information. . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . to avoid publication bias, we will search for published studies in multiple databases which include published journal articles and preprints. every study will be evaluated and discussed considering its bias and strengths for inclusion in the review. we will report the number of articles that do not fulfill requirements. for studies with two documents (preprint and journal publication), the official publication will be considered. in the studies with more than one analysis, the most tailored to our study aim publication will be considered. funnel plots will be performed for publication bias if we have enough data. a descriptive analysis of the included studies will be conducted through a flow diagram describing the number of included and excluded studies, exclusion reasons (e.g. older population not included, different epidemic/pandemic exposure, non-mental health outcomes), and the final number of selected studies. the results will be synthesized in tables and figures which may include the following. table will display study characteristics (country, data source, data collection dates, year, type of study/study design, total sample by group, follow-up, participants basic characteristics, exposed epidemic/pandemic), table outcome measurement (name of the outcomes, type of outcome -mental health/psychosocial-, outcome measurement, and results). a third table will describe intervention studies and its results (country, data collection and intervention delivery dates, year, type of research design, inclusion/exclusion criteria, description of the intervention, exposed epidemic/pandemic, sample by group, intervention/control characteristics, outcome measurement, results). data synthesis will be performed according to study type and design, type of epidemic and pandemic, types of outcomes (mental health and psychosocial outcomes), and participant characteristics (sex, race, comparison to other age groups, independent/dependent older adults). comparison between sex, race, and other age groups will be performed qualitatively, and quantitatively if the data available is enough. the risk of bias and heterogeneity will be reported for quantitative studies published in journal articles or preprints. if the available data is enough, we plan to conduct a subgroup analysis considering the following categories: type of study design, type of outcome measured, type of epidemic, or pandemic. if the data available is enough quantitative comparison of age groups will be conducted. we will perform a sensitivity analysis based on studies with a low risk of bias. mental health understood as a state of wellbeing has been a topic of special discussion and concern in the health and medical sciences because of its impact on the people's lives and the high burden for societies. in the context of large-scale natural disasters such as epidemics and pandemics, mental health would be highly determined by the manifestation of mental illnesses, neuropsychiatric conditions, and psychosocial aspects that will influence people's health and their capacity to cope with a mentally demanding . cc-by-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted june , . . situation. this topic takes major relevance in the current scenario triggered by the covid- worldwide pandemic, where there exist and evident relevance of understanding the patterns of mental coping and adaptation of the global population. in our actual society, people years or older have been increasingly exposed to situations that are a threat to their mental health such as isolation and loneliness. at the same time, the constant exposure to 'ageism' or negative stereotypes associated with the aging as well as classifications of 'population of highrisk' or in need of shielding could be an important source of stress, fear, and segregation. nevertheless, even in the presence of these negative ideas about older people, the evidence has been uncertain about older adult's mental resilience and adaptation compared to other age groups in front of natural disasters. under normal situations, older adults have shown that they report higher general wellbeing and satisfaction with social connection than the younger groups. to our knowledge, this is the first systematic review evaluating the older adult's mental and psychosocial health compared to other age groups in the context of acute respiratory disease epidemics and pandemics. therefore, to understand how mental and psychosocial health could change during epidemics and pandemics of similar characteristics than covid- in older adults in contrast to other ages will be critical to elucidate the natural emergence of mental and behavioral coping mechanisms across life-stages, and to comprehend the major necessities referred by these groups. this information will be critical for the design of interventions and policies oriented to increment positive behavioral changes across age population groups and to promote the adherence to nonpharmacological preventive measures during epidemics and pandemics. promoting mental health: concepts, emerging evidence, practice (summary report). geneva: world health organization what is mental illness? washington: american psychiatric association multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science infection prevention and control of epidemic-and pandemic-prone acute respiratory infections in health care: who guidelines. geneva: world health organization, . .-shimizu k. -ncov, fake news, and racism mental health status of people isolated due to middle east respiratory syndrome stress and psychological distress among sars survivors year after the outbreak long-term psychiatric morbidities among sars survivors psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the covid- pandemic older adults presenting characteristics, comorbidities, and outcomes among patients hospitalized with covid- in the new york city area baseline characteristics and outcomes of patients infected with sars-cov- admitted to icus of the lombardy region out-of-hospital cardiac arrest during the covid- outbreak in italy active coping shields against negative aging self-stereotypes contributing to psychiatric conditions experiences of ageism and the mental health of older adults moderate to severe depressive symptoms and rehabilitation outcome in older adults with hip fracture factors mediating the effects of a depression intervention on functional disability in older african americans psychosocial and socioeconomic determinants of cardiovascular mortality in eastern europe: a multicentre prospective cohort study the relationship of psychosocial factors to total mortality among older japanese-american men: the honolulu heart program are older people more vulnerable to long-term impacts of disasters? individual, community, and national resiliencies and age: are older people less resilient than younger individuals? mental health implications for older adults after natural disasters--a systematic review and meta-analysis social and emotional aging aging and attentional biases for emotional faces unpleasant situations elicit different emotional responses in younger and older adults selective optimization with compensation a meta-analysis of the impact of covid- on the mental wellbeing of elderly population the prisma statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration systematic screening and assessment of psychosocial well-being and care needs of people with cancer. cochrane database syst rev eppi centre covid- : a living systematic map of the evidence screening review what is the impact on health and wellbeing of interventions that foster respect and social inclusion in community-residing older adults? a systematic review of quantitative and qualitative studies challenging mental health related stigma in china: systematic review and meta-analysis. i. interventions among the general public chinese classification of mental disorders (ccmd- ): towards integration in international classification the strengthening the reporting of observational studies in epidemiology (strobe) statement: guidelines for reporting observational studies cochrane handbook for systematic reviews of interventions version available from www.training.cochrane.org/handbook social isolation and loneliness in older adults-a mental health/public health challenge key: cord- - rvis gy authors: modell, stephen m.; kardia, sharon l. r. title: religion as a health promoter during the / covid outbreak: view from detroit date: - - journal: j relig health doi: . /s - - - sha: doc_id: cord_uid: rvis gy the / covid outbreak has surfaced as a global pandemic. the news has carried stories of the heroic efforts of medical and other health practitioners, with public health officials charting the course of spread. in an urban center like detroit, the generosity of everyday citizens and church organizations has also played an important role. this inspection of the pandemic from the view of detroit will examine the epidemiology of the coronavirus, translation of professional practice into people’s awareness of the chronic disease risk factors which are prevalent in detroit, moral and ethical views on the distribution of resources, and three major ways that religious faith has helped to sustain people’s health and welfare in the midst of the broad social challenges posed by this novel coronavirus. a career day presentation at detroit country day school on a typical day in the life of a public health academician turned into a consoling letter for at-home students on the importance of prevention and the essential value of public health among the other health-related professions. a nephew returning in a rush to chicago from israel caught the coronavirus and then thankfully recovered within weeks, possibly due to his age, having recently graduated from college. the centers for disease control and prevention (cdc) released its -page interim guidance for administrators and leaders of community-and faith-based organizations to plan, prepare, and respond to coronavirus disease which contained diplomatically worded, now understated instructions to "monitor and plan for absenteeism" (cdc , p. ) . in truth, detroit is known for its myriad overly active churches, mosques, and synagogues, all of which were ironically desolate on days commemorating the rebirth of a religious figurehead, new meaning and prophetic promise, and the freeing of a people from bondage. in this inspection of the covid- pandemic, the health status of the city of detroit will be assessed, considering chronic disease contributors and awareness of those contributors. resources are in short supply; the ethics of provider and interventional availability will be considered. community health needs assessments, which in detroit receive input through the efforts of religious community-based organizations, offer one measure of local health and health policies. religious faiths have been sustaining the health and well-being of city residents in connection with the pandemic along three broad fronts that will be tied together in the latter portions of this view from detroit. at our institution min from detroit, as of april the university of michigan medical center reports covid- inpatients, of whom have tested positive (michigan medicine ) . in the heart of detroit, henry ford hospital reports inpatients testing positive and outpatients with positive disease status . about half the cases in michigan are nested in wayne county, of which detroit is the largest city. the cdc and world health organization place at higher risk adults over and those with chronic medical conditions (hypertension, obesity, diabetes, lung disease, heart disease, and those with compromised immune systems) (garg et al. , p. ) . the cdc office of public health genomics has noted the potential for specific biological factors (the ultimate goal of diagnostic and therapeutic targeting)-ace genetic variants, interleukin- , hla antigens, and particular blood groups-to be risk factors in covid- severity and outcome (khoury et al. ) . risk factors for viral transmission and severity should include elucidation of both viral and human genomes and their interaction. however, it also notes the important role environmental, social and economic factors, and compiled "big data" play in this kind of outbreak. dr. teena chopra, an infectious disease professor at wayne state university who is working with coronavirus patients at detroit medical center, underscores this point: "the high rates of social disadvantage and higher comorbidities make the city of detroit more vulnerable to . so these are the reasons why detroit is, as far as predictions are concerned, showing the steeper curve, and steeper than even new york" (guardian ) . about a third of the people in detroit live in poverty. states dr. abdul el-sayed, who resurrected the detroit health department from the city's municipal bankruptcy in , "i think if you're working an $ -an-hour job that has no paid sick leave and no protection guarantee, that being forced to go out and do your job or lose it in the middle of a pandemic is going to increase your probability of either contracting an infectious disease or transmitting it" (bach ) . among the covid- biological risk factors, el-sayed observes that out of detroit adults are obese, which increases their chances for heart disease and diabetes, and the rate of asthma hospitalizations is more than three times the state average (nather the detroit health department is quite active in the midst of the pandemic, providing free covid- testing; charting the virus' spread in the city by zip code; maintaining a readily viewable covid- data dashboard (e.g., showing drive thru testing results and total number of detroit shelters that are screening); and maintaining a covid- call center. these are ambitious activities considering that when el-sayed took over, the department was down to people (now it has more than ). dr. el-sayed's efforts are not singular, though. the m.d., m.p.h. down the hallway from the authors is a busy member of the governor's michigan coronavirus task force on racial disparities. immediately across from the authors is a flu investigational research group that has been pulling in and compiling influenza, respiratory syncytial virus, and covid- case data from three hospital systems, including henry ford hospital in detroit, on a daily basis. heroics take place both in the emergency room and the public health setting. shortly after the severe acute respiratory syndrome (coronavirus sars-cov) pandemic, a toronto physician who had three previous generation family members die in the spanish flu pandemic of wrote about the ethical clashes a healthcare provider experiences under such circumstances (sawa , pp. - ) . two major dilemmas, and decision points, occur. the provider must choose: ( ) between the good of an individual person (say, him-or herself or a dear patient) and the well-being of the public and ( ) between helping those closest to him or her (family members) and public duty. sawa concluded, "the solution is not simply to move from a conscience-based ethics to a utilitarian-based approach. there will be conflicts in such circumstances between the public health providers and individuals. at times there may be no obvious or 'correct' answers to the dilemmas which emerge. … during such crises, moral development is challenged to grow" (sawa , p. ) . a pragmatic approach would be to streamline the health system. administrators could anticipate ahead of time the scarcity of resources (vaccines, drugs, ventilators, and hospital beds); assess people's values on their distribution; and train health care workers to make decisions about what would be required of them in the future. consideration of a pandemic from a moral perspective would challenge providers to consider how they would face different kinds of moral reasoning: level is that of justice without mercy (i.e., strict utilitarianism); level "is the level of love based on respect. this level is based not on our love, but on how god loves us." level transcends this level to one of self-sacrificing love. it requires a flexible balancing between the individual, and the society or community. ultimate guidance during a pandemic is neither deterministic nor egoistic. it embraces the needs of all parties the provider could help. the precepts of our current healthcare providers and public health practitioners are guides for future health professionals. for the last years, michigan state university and the university of michigan school of public health have been hosting the new genomic framework for schools and communities curriculum in the underserved cities of detroit and flint, michigan. this national institutes of healthfunded program has brought an understanding, through classroom experiences and community action projects, of diabetes (sixth grade) and addiction (seventh and eighth grades) to middle school students, their families, and the surrounding community (bayer et al. ). an addiction curriculum panel and mini-workshops composed of adults judging the student projects-representatives from the county health department, health insurance plans, a health research center, and universities-gave students a look at professions that could one day be theirs. the closing event questionnaires and adult interviews also demonstrated an educational type of health preparedness. a teacher attending a diabetes closing event said that he learned about healthy foods and how to prevent diabetes from the students and the professional speaker. parents interviewed shared how the youngsters learned about diabetes in their father and grandmother, and came home talking about what they eat. a number of students explored the different types of chronic disease which happen to be risk factors in the current dilemma. detroit closing event participant # , a parent, revealed, "she likes to look up different stuff to her question of the day. one example-she looked up stuff about breast cancer, diabetes, and asthma on the internet." a third level of awareness demonstrated by student and attending community member comments involved connection with broader issues, such as associations with conditions like obesity, and the availability of healthy foods in the inner city. the science education partnership award (sepa) program is one way of educating students and their families about chronic disease risk factors, and how they tie in with broader social conditions. detroit and most other american cities are currently experiencing a shortage of resources-testing kits, respirators, and beds-the very items dr. sawa's article anticipated. in a city in which one-third of the residents are poor, it would be expedient to provide care to only those who can afford it. scripture has a perspective on resource bottlenecks. father stanley harakas relates the eastern orthodox view: "neither the ability to pay nor an aristocratic criterion of greater human value or worth is acceptable. … in spite of the enormous difficulties involved, the ethical imperative from the orthodox perspective calls for the widest distribution of health care and life-protecting resources facilities and resources, rather than a concentration of such resources for the select few" (harakas , pp. - ) . laurie zoloth, ethicist and jewish studies scholar, refers to isaiah : that the poor person is to be valued far above the king: "this is the fast i desire: … it is to share your bread with the hungry, and to take the wretched poor into your home. when you see the naked, to clothe him and not to ignore your own kin" (zoloth , p. ) . the revision of the public health code of ethics views health justice and equity as core values: "human flourishing requires the resources and social conditions necessary to secure equal opportunities for the realization of health and other capabilities by individuals and communities. … in addition, health justice does not pertain only to the distribution of scarce resources in transactions among individuals; it also involves remediation of structural and institutional forms of domination that arise from inequalities related to voice, power, and wealth" (apha , p. ). the attempt in to establish universal health care by the clinton administration considered health insurance to be a social good, everybody's right. this view can be contrasted with that of the current freedom caucus in the usa, which is that government should not be in the business of providing health insurance, and that it is to be considered a market good (mack ) . the patient protection and affordable care act (aca) has acted under the first premise, despite having been moved closer to the middle since its inception. among its accomplishments, the aca has provided health insurance to million americans who would not otherwise own it. as part of this figure, . million individuals have been enrolled into medicaid and the child health insurance program as a result of medicaid expansion granting eligibility to people with incomes up to % of the poverty level. large numbers of people with or at risk of covid- are now entering hospitals through emergency room doors. hospitals are required to pay for care for those unable to afford it, while the patient remains in emergency, but not to provide follow-up care, such as for surgery or chronic conditions like cancer and diabetes (mack ) , risk factors that underlie coronavirus susceptibility. the societal decision in favor of health care as a social good remains vitally important during the outbreak. the aca has additionally mandated new irs requirements for both public and private hospitals to perform a system-wide check-up called a "community health needs assessment" every years, and to adopt an implementation plan addressing community needs. these chnas have come to the aid of high racial-ethnic composition, low-income populations in cities like the bronx of new york, south chicago, and detroit. the top three stakeholder identified social determinants of health needs in the detroit henry ford health system chna were: poverty/low income (# social issue); housing (# ); and access to healthy food (# ) (henry ford health system , p. ). the michigan behavioral risk factor survey - shows that % of detroit residents are overweight and % are obese, health characteristics the chna reports to be on the rise. in addition, the henry ford macomb hospital, located north of detroit, reported diabetes as a priority area. implementation goals in these locations-increased consumption of fruits and vegetables and reduction of body mass index (bmi) in diabetic patients-bear more than a passing resemblance to the dietary and exercise-related lessons in our middle school genomics curriculum, leading us to believe we have given shape to at least a few students' future ambitions. we appreciate that other states will have different priorities. south of the michigan border in franklin county, ohio, which contains that state's metropolitan capitol, columbus, chronic conditions are # on the list of prioritized health needs, and infectious diseases (vaccine-preventable infections, sexually-transmitted diseases) are # (mount carmel health system , p. v). the health priorities in both states' health systems are relevant to the theme of coronavirus prevention. in the henry ford health system chna, input was gathered by a variety of mechanisms, including stakeholder surveys, focus groups, and community member feedback. the types of organizations providing input to the chna were health-related, educational, civic, and faith-based, among other categories. in detroit, of the organizations providing input were faith-based (e.g., second baptist church of detroit, lord of lords church, and faith community nursing). our research team has long been aware of the importance of religious community-based organizations for recruiting grass-roots participants for values discussions and dialogs relating to new health interventions. in our nih-funded communities of color and genetics policy project looking at people's attitudes toward new genetic technologies, of the participating community organizations were faith-based (e.g., bethel ame church in ann arbor, mi; faith access to community economic development in flint, mi; and clinica santa maria in grand rapids, mi) (bonham et al. , p. ) . members of these churches and organizations were entirely african-american and latino, affording a distinct look at the hopes and concerns of people who have experienced marginalization, discrimination, and transience in their own lives. detroit has many active communitybased organizations. the churches and other faith-based organizations are especially aware of the social obstacles and healthcare deficits experienced by their community members. religious involvement in health promotion represents both sides of the coin. on the heads side, religion serves as a source of hope, which is greatly needed emotionally and in a life-sustaining sense during the current crisis. on the other side, religion provides practical services that bolster health and welfare. many people consider themselves more spiritual than religious, but it is the organized nature of religious institutions that is coming to the rescue during the widespread financial and food shortages being experienced. in public health, we consider health promotion to be mediated by health facilitators and deterred by health barriers, which are often physical factors or people advocating for health (kieffer et al. , p. ). in the current dilemma, religion as a health promoter is active in terms of what the churches, temples, and mosques are accomplishing, and their members are carrying out. it is important to recognize that churches have been longstanding partners in health promotion along with public health and medical organizations. lasater and colleagues divide health-related church activity into four levels: (i) the church serving only as a venue for recruiting participants into collaborative health programs; (ii) the intervention delivery occurs on-site at the church, e.g., educational sessions and group classes; (iii) involvement of congregation members in program delivery, as might be carried out by trained lay health workers from within congregational ranks; and (iv) delivery of program elements that include both health messages and religious readings, such as scriptural or ethical guidance, that link religion and health (campbell et al. , p. ; lasater et al. , pp. s -s ) . a level ii diabetes prevention program implemented in bronx and harlem churches in new york was aimed at improving nutrition and physical activity levels utilizing a consultant fluent in spanish from the community with a faith orientation, and another who was a nutrition and diabetes educator (gutierrez et al. ) . a level iii prevention program aimed at obesity, diabetes, and hypertension in african-american mississippi delta churches contained dietary/physical activity educational sessions led by program staff and a trained church committee member (tussing-humphreys et al. ) . a level iv diabetes prevention program in african-american churches in augusta, georgia, was based on core information and risk improvement sessions and utilized input from a community (faith-based) and university advisory board in all aspects of project planning. the board's recommendations resulted in the inclusion of select scriptures and sociocultural preferences in the group lifestyle balance curriculum (sattin et al. ) . these programs registered statistically significant outcomes in regards excess eating, blood glucose levels, physical activity level, and personal weight; two involved control arms; and the bronx-harlem program stratified results by race-ethnicity, including identification of group-specific obstacles and motivating factors. churchbased programs are not contoured for late secondary prevention; that is, treating the manifestation of disease like diabetes or cancer. however, they do have a place in primary prevention of disease by mitigating the risk factors involved. the effects of these three programs will not end when the programs themselves end. the church participants are left with new knowledge and tools which can be utilized at any time. in fact, most people during the pandemic have found themselves sequestered to home, where time exists to engage in one's preferred physical activity, and to manage the content of meals, at least as far as these practices relate to the first three chronic disease risk factors for covid- . pondering the universe's vastness and our capacity to take a fall while traversing it, emerson affirmed, "we judge of a man's wisdom by his hope" (emerson , p. ) . compared to tangible interventions, hope is a more abstract quality, but one that can lead to health and the will to seek it. paul scherz ( ) delineates three stances toward scripture that pertain to personalized medicine: ( ) setting aside anxieties over risk and leaving worldly concerns to god's care; ( ) using natural regularities to provide security while realizing that the future is in god's hands; and ( ) looking to social factors that structure risk, such as friends or the work environment. these avenues of hope can be generalized to the diversity of religious faiths. while the first stance has been used in decisions over whether to except a newborn from neonatal blood screening, the consequences of leaving population health purely to god and fate during a pandemic are quite stark. even invoking the goal of herd immunity free of intervention would lead to hundreds of thousands of deaths. better an appreciation that god, or one's personal definition of a universal presence, abides with us as we experience calamity and take whatever steps seem wise. indeed, a british study on the knowledge and beliefs of patients newly diagnosed with cancer found that fatalistic beliefs ("cancer is caused by fate and nothing can be done to prevent it") explained only . % of the variance in anxiety scores over the spread of cancer (lord et al. , p. ) . other attitudes toward the spread of disease supersede a sense of fatalism in people's hopes and fears about what might eventuate. a sense of hope provided by religion can determine whether one engages in healthy practices in the disease context or lets things slide. two interviews from patients with diabetes, the second recovering from a lower leg amputation, depict this stance: my happiness would be within him. … and when i'm at peace, then my body is at peace. i start doing things, i start going to church or wherever i need to go to worship, exercise, time for this and that (choi and hastings , p. ). [spirituality] helps to get by, just like every day. it helps with getting out of bed and getting on with the day, and just do something. it helps to try to walk and "i can do it, yes i can do it, i can do it …" and i can't do it now, but i can do it, i will do it (unantenne et al. (unantenne et al. , p. . these statements also apply to conditions in the middle of the covid pandemic. healthy people out of work and without the normal activities of daily living need inspiration to keep moving. for people grieving a loved one or personally recovering from the virus, a sense of hope can help them to simply get through the day. a third patient refers to the hope spirituality can give through people on whom one can rely: it does help me because you realize you've got support … you've got other people of a like mind around you, and it gives you the strength to keep going … a vision that goes alongside your everyday living. you draw strength from it for everyday living … (unantenne et al. (unantenne et al. , p. ). in the inner city, other people can be very helpful in times of crisis. detroit has stories of teachers going to homes and asking what residents need, immigrant specialists delivering diapers and food to their clients, and neighbors tilling the soil of nearby community gardens for each other as summer approaches (alvarez and clark ) . churches that allowed ten congregants per service early in the outbreak, which provided emotional support to helpers and those being helped alike, have stopped this practice in the wake of state disease prevention rules promulgated by gov. gretchen whitmer. places of worship have been determined and resourceful, though, adapting to circumstances by holding drive-in (in-vehicle) and online services, and transmitting messages of hope on the social media. in detroit, places of worship have been responsive and adaptive to policy. perhaps, the biggest transmitted message of hope was delivered by renowned italian opera singer andrea bocelli on easter sunday when he conducted a one man performance entitled "music for hope" in the foreground of milan's duomo cathedral with the goal of uniting the world during the pandemic. the mission was a success, breaking live-stream classical music records with an all-time million views. the most evident symbol of religious involvement in sustaining the health of detroit citizens during the pandemic lies in the essential social services the churches are performing. residents are reeling from inability to go to work and the closure of food establishments. the city is already known for being a "food desert" marked by a shortage of nearby grocery stores and healthy food markets. here is an example listing of the services churches are rendering during the outbreak: these services are most frequently performed on behalf of those who for a variety of reasons have been marginalized from what most families take for granted, though with the outbreak, this circle has enlarged. the persons and organizations delivering these services are the unsung heroes of covid- . we are especially appreciative of the laptop provision to young students (allen ), having tested with our middle school students the use of chromebooks and ipads to visualize how genes interact with the environment in sand rat simulations and to model the effects of gene-environment interactions on health using a dynamic model building program, and found that computers seem to be a favored learning method among middle school students! schools are closed during the pandemic, but not all families have computers to upload online lessons. triumph's generous efforts will help both young students and their families. the educational project is a collaboration; the schools themselves provided the digital device and computer laboratory access. neighbors preparing community gardens for each other; deliveries by one community resident to another; social services being performed by the churches; churches securing laptops for young students during school closure-these attributes are known as "community assets" (wallerstein et al. , p. ) . in the midst of calamity, detroit is both depending on an expert healthcare system and bringing its own community assets to bear. charles dickens opens his classic novel a tale of two cities with the well-known statement: "it was the best of times, it was the worst of times … it was the season of light, it was the season of darkness, it was the spring of hope, it was the winter of despair…." (dickens , p. ) . though this passage was directed at the contrast between british and french society and the haves and have nots, it very much applies to current circumstances, especially to urban centers swirling in the eye of the pandemic. divisions exist between the different sectors and those who have enough to get by living alongside families barely surviving. the city's functioning displays the socio-ecological model in operation, not just as a chalkboard conception (modell et al. , p. ; campbell et al. , pp. - ) . the overall incidence of infection depends on its incidence among population subgroups, which is contingent on its diagnosis at the site of testing. access to medical care is linked with steps that are being taken in the work environment and home environment. the survival of critical cells helps assure functioning at the organ level (heart, lungs, and immune system), which governs an individuals' health, with influence from their surrounding family, community, and the country's level of preparedness. the two vectors in the model-"the world affects us" and "we affect the world"-represent the necessary collaboration taking place, a bit different from the social clashes of dicken's novel. the newspapers of mid-april provide a slice in history of a city roiling in pandemic yet arched toward recovery if the fates will permit it. one can trace different strands in the city's reaction. the pandemic has affected each individual to the core, exposing deeply human emotions. people working together, and unfortunately the spread of disease between people, show it to be a social phenomenon, with churches as salutary, ever working participants. for scientists and medical and public health practitioners, it is a time of great, amassed energy, trying to contain the spread and keep people alive. in the april /may , , "finding hope" special issue of time magazine, the dalai lama captured this point in history with the following words: this crisis shows that we must all take responsibility where we can. we must combine the courage doctors and nurses are showing with empirical science to begin to turn this situation around and protect our future from more such threats. … as a buddhist, i believe in the principle of impermanence. eventually, this virus will pass, as i have seen wars and other terrible threats pass in my lifetime, and we will have the opportunity to rebuild our global community as we have done many times before (dalai lama , p. ). in dickens' great expectations, the protagonist philip pirrip ("pip") is the beneficiary of an unexpected fortune, but at the same time he experiences hardships from the continued aloofness of estelle, the imprisonment and death of his benefactor, magwitch, and the consequent loss of his (pip's) fortune to the crown and by helping his friend financially (dickens , pp. , , ) . toward the very end pip has regained his footing through sheer work and self-initiative to become a senior partner in his friend's firm, and in dickens' revision the hint exists that the cruelties of life have made estelle into an enduring companion. before the crisis, the view from the tall buildings of detroit was of a city on the rise. the covid- pandemic has gutted the health and well-being of the major american cities, with detroit at the front. on the road to recovery, which is matter of time, patience, and collective effort, detroit's residents and those in the surrounding communities will surely depend on the types of faith the dalai lama has articulated. detroit church adapts to pandemic with drive-in services, loaner laptops for students in battle-tested detroit, neighbors help each other as coronavirus spreads public health code of ethics why covid- is a disaster for detroit impact and lessons learned from a school-academic-community partnership in sharing urban youth community research projects on type- diabetes as a health promotion strategy community-based dialogue: engaging communities of color in the united states' genetics policy conversation church-based health promotion interventions: evidence and lessons learned interim guidance for administrators and leaders of community-and faith-based organizations to plan, prepare, and respond to coronavirus disease (covid- ) religion, spirituality, coping, and resilience among african americans with diabetes great expectations a tale of two cities spiritual laws. emerson's essays, st and nd series hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease -covid-net, states detroit: america's next covid- hotspot battles to prepare for coming surge evaluation of a multicultural faith-based diabetes prevention program for the health of body and soul: an eastern orthodox introduction to bioethics community health needs assessment henry ford health system covid- cases the public health impact of covid- : why host genomics? the application of focus group methodologies to community-based participatory research thoughts, not prayers synthesis of findings and issues from religious-based cardiovascular disease prevention trials the beliefs and knowledge of patients newly diagnosed with cancer in a uk ethnically diverse population what america needs to decide: is health care a market good or social good? michigan's covid- cases, deaths hit blacks disproportionately. detroit news vital statistics-selected chronic disease indicators, wayne county health department residents covid- update the ecological model in genetics and religion community health needs assessment in the poorest big city in america, he's bringing the health department back to life community trial of a faith-based lifestyle intervention to prevent diabetes among african-americans bioethics for the twenty-first century. ultimate reality and meaning: interdisciplinary studies in the philosophy of understanding risk in christianity and personalized medicine: three frameworks for understanding risk in scripture total number of cases of coronavirus (covid- ) in the united states as of number of deaths from coronavirus (covid- ) in the united states as of a church-based diet and physical activity intervention for rural, lower mississippi delta african american adults: delta body and soul effectiveness study the strength to cope: spirituality and faith in chronic disease developing and maintaining partnerships with communities health care and the ethics of encounter: a jewish discussion of social justice the authors extend their gratitude to irene bayer for reviewing the sepa projectrelated portions of the manuscript. key: cord- -h ukbbom authors: correa, humberto; malloy-diniz, leandro f.; da silva, antonio g. title: why psychiatric treatment must not be neglected during the covid- pandemic date: - - journal: braz j psychiatry doi: . / - - - sha: doc_id: cord_uid: h ukbbom nan the covid- pandemic is related to inefficient risk assessment by the chinese government, which hampered efforts to contain the virus. strategies for controlling the current situation are still not efficient for mass diagnosis, clinical approaches or prevention. government efforts and healthcare practice have been directed to central aspects of the pandemic. for example, one discussion trend is severe acute respiratory syndrome, including its implications for the public health system and its economic and social impact. in the current crisis, mental health actions should not be forgotten or postponed. as highlighted by silva et al., these actions include behavioral measures to facilitate social distance, identifying cognitive mechanisms and decision styles that can increase risk exposure, as well as the mental health care of professionals who deal directly with the consequences of the pandemic. moreover, care must be prioritized for psychiatric patients, who, due to stress, are at considerable risk of clinical worsening. a widespread worsening of psychiatric symptoms during the current crisis could contribute to the collapse of the health system. ornell et al. highlight public policy actions (e.g., developing psychoeducational materials for the general population) and individual actions (e.g., monitoring dysphoric symptoms, maintaining social support networks) that can be taken. they also highlight the need for care and attention to particular groups (e.g., psychiatric patients), as well as actions that institutional health centers can implement to manage mental health during the pandemic. it is evident that mental health is an issue of immediate interest in this crisis, and postponing attention to it could be a serious error. we are greatly concerned about initiatives that classify mental health and psychiatric hospital care as a secondary issue. for example, in minas gerais, closing the hospitalization and emergency care unit of the hospital galba veloso is on the government's agenda. the high prevalence and functional impact of psychiatric disorders could increase in severity and incidence in the coming weeks, leading to an increase in demand for psychiatric emergency services. in addition, many patients in acute settings may not be able to understand or cooperate with the need for isolation and quarantine, especially those who suspected of being infected with covid- . since such patients may require hospitalization in a psychiatric ward or in isolation, decreasing the number of beds may lead to further spread of the disease. apart from threats of bed closures and ending emergency care, psychiatric hospitals must be prepared to provide social support during the crisis. as pointed out by zhu et al., psychiatric hospitals must have a specific approach for dealing with segments of the population that need additional attention, including hospital resource management strategies, different types of mental health intervention, and guidance for the family members of covid- victims. in this time of crisis, when effort is required in many areas, investing in the mental health of psychiatric patients and the general population is not a luxury. humberto correa, , leandro f. malloy-diniz, , , antonio g. da silva , , - - - the sars, mers and novel coronavirus (covid- ) epidemics, the newest and biggest global health threats: what lessons have we learned? the novel coronavirus (sars-cov- ) is a one health issue mental health: why it still matters in the midst of a pandemic pandemic fear'' and covid- : mental health burden and strategies the risk and prevention of novel coronavirus pneumonia infections among inpatients in psychiatric hospitals the authors report no conflicts of interest. key: cord- -wdkdc pw authors: baral, stefan david; mishra, sharmistha; diouf, daouda; phanuphak, nittaya; dowdy, david title: the public health response to covid- : balancing precaution and unintended consequences date: - - journal: ann epidemiol doi: . /j.annepidem. . . sha: doc_id: cord_uid: wdkdc pw nan since the beginning of the covid- pandemic, public health decision-makers have been called upon to identify responses that are appropriate in intensity, duration, and scope. in march , epidemiological models of potential epidemic trajectories rapidly became a primary tool used to inform such decisions. early models focused on estimating fundamental quantities and projecting the speed at which generic interventions should be deployed to subvert early spread [ ] . models were developed using available data in real time, with a primary aim to enhance understanding of transmission and clinical severity. however, foundational insights of transmission dynamics are not public health implementation specifics. understanding the impact of a single intervention strategy compared to nothing on the sars-cov- reproductive rate, for example, is not the same as studying the impact of different strategies to mitigate transmission risks. foundational insights generated from these models shaped a global pandemic response that has largely taken the form of large-scale government mandates -including shelter-in-place orders and closure of non-essential businesses, collective outdoor spaces, schools and universities. the far-reaching nature of these measures reflected an immediate urgency to halt explosive infectious disease growth. as the pandemic has evolved, however, we have learned that this epidemic, like many before it, is characterized by tremendous heterogeneity at the level of countries, states, cities and counties, neighborhoods, congregate settings, and even households [ ] [ ] [ ] . translating fundamental insights from epidemiological models into effective public health practice implies transparency about the conditions upon which insights are projected into estimates with the most common condition of covid- models being of a homogenous population with relatively homogenous social networks. however, there are consequences to a top-down mandate of non-specific responses onto a heterogeneous population. non-specific primary prevention approaches are known to increase disparities by further marginalizing those already at highest risk of severe outcomes -including people living in congregate settings and people of disadvantaged communities who may also have poorer existing access to care and higher rates of comorbidities that increase risk of poor covid- -related outcomes [ ] . as an example, the closure of businesses has had a dramatic economic effect on populations already generally at the margins, with tens of millions of people filing for unemployment in the united states alone and countless more seeing their "gig economy" incomes fall dramatically. there have also been significant disruptions to the health system with currently unmeasured, but potentially substantial, increases in morbidity and mortality associated with diversion of resources away from prevention and treatment of cardiovascular disease, mental illness, acute illnesses, reproductive health, cancer, and other infectious diseases -to name a few [ ] . similarly, disruptions to the educational system at all levels may have downstream effects on the health and well-being of individuals, populations, and the economy [ ] . evaluating the implementation of more nuanced strategies will require us to look deeper for evidence as to how and why specific activities helped reduce epidemic spread, for whom, when, and under what conditions. the media has commonly portrayed that the primary factor differentiating "successful" and "unsuccessful" responses is the speed and intensity with which broad-scale policy change has been enacted. we hail leaders, for example, whose responses have been swift and strong while decrying those whose responses have been delayed or less stringent. but this reaction may selectively overlook specific cities, regions, and even countries where there have been disconnects between the level of stringency and incidence rates of covid- . for example, arkansas has among the least stringent measures of any state and as of april th , has half the number of cases per capita as compared to its neighboring state, mississippi. sweden has received significant international press for its intentionally relaxed response and yet has fewer cases per capita than many countries -including belgium, switzerland, and francethat swiftly enforced shelter-in-place restrictions. the disconnect between epidemiological trajectories and intervention intensity can also be observed in countries across asia and africa. focusing on high-level, broad policy decisions as singular causal determinants belies a complexity and heterogeneity of transmission dynamics to be considered if we are to move from "flattening the curve" to turning it downward. this complexity occurs on many levels, including individual-level determinants of health, community-level patterns of interaction based on local economies and population density, structural factors including health disparities and policy environments, environmental factors such as seasonality and air pollution, and of course factors related to the effectiveness and efficiency of public health interventions themselves. relative to earlier public health emergencies, our ability to gather additional layers of information, such as those generated with "big data", and analyze those data with computational tools of increasing complexity has grown tremendously. there are many types of models, including, but not limited to, those designed to estimate the local rate of spread; to forecast cases; to elucidate fundamental mechanisms such as the relative contribution of pre-symptomatic or subclinical transmission and the relative importance of each key element of the reproductive rate; and to compare the potential impact of various combination of strategies. all are useful to the response because they answer different questions. what are needed during the next phase of pandemic response are models validated against and adapted to as much real-world data as possible to help answer questions about which specific interventions to employ, in which populations, at what time, and under what context. ensuring that epidemiological data are routinely collected on the characteristics of covid- testing, cases, and deaths is critical in guiding these analyses; data such as socioeconomic status, race and ethnicity, residence in a congregate living setting such as a homeless shelter, long term care facility, or in detention of some form. we must also explicitly acknowledge where the limitations of the currently available data challenge the ability to examine the comparative effectiveness of different interventions. it is also important to consider the health effects of the covid- response in a broader sense, and begin to consider short-, medium-, and long-term implications. these implications will include impacts on other health conditions, including other infectious diseases and chronic diseases. for example, prolonged reductions in access to routine healthcare may increase adverse outcomes from cardiovascular events such as myocardial infarctions and strokes, cause longerterm morbidity and mortality through suboptimal management of hypertension, blood sugar, hypercholesterolemia; interrupt prevention of other infectious diseases through vaccination, testing, and pre-exposure prophylaxis, outreach services; weaken management of acute and chronic mental health needs; limit cancer screening and prevention services; and challenge the delivery of family planning services including contraception [ , ] . the trade-offs and opportunity costs of broad government mandates in response to the covid- pandemicincluding effects on socioeconomically marginalized communities -must be urgently considered by models designed to answer these broader questions. by focusing attention primarily on covid- cases and deaths and pitting those against models of economic harm, we risk undervaluing the larger-scale and longer-term health of individuals, communities, and populations. as we enter the next phase of pandemic mitigation, the response will need to better align with what the data are telling us: there is differential risk in the acquisition, onward transmission, and consequences of covid- -and its mitigation strategies -across people, places, and time. it is tempting to look at countries, states, and cities that enacted immediate, broad-scale measures and now have smaller numbers of covid- cases as "success stories" -but these same disruptions to routine healthcare systems in those settings may end up generating more deaths due to other conditions than would otherwise have been caused by covid- . the covid- pandemic is, and will continue to be, characterized by settings and populations of higher and lower disease burden. as we develop mathematical models to guide programs and implementation strategies for the next phase of pandemic response, it will be increasingly important to: a) account for implementation-relevant heterogeneity in the epidemiology of cases and morbidity and mortality as well as in the response; and b) holistically consider not only the breadth of potential health outcomes resulting from covid- and the corresponding response, but also the heterogeneity of epidemic burden, health systems culture and infrastructure, and existing health disparities at the local, state/provincial, and national levels. in summary, our success as a society in combating covid- will rapidly be judged by how effectively we can move from a "one-size-fits-all" approach to a locally responsive, nuanced public health strategy that accounts for both an increased breadth of health consequences and the striking epidemiologic heterogeneity that has characterized the pandemic from its beginning. to date, the covid- response has appropriately been guided by the "precautionary principle" in epidemiology which suggests that we must intervene swiftly and aggressively when faced with a new public health risk of uncertain proportions [ ] . as data to inform a more strategic approach emerge, however, we must begin to move from a precautionary position to one that also considers the proportionality and specificity of the public health response, with the overall goal of maximizing population health. the health and lives of our most vulnerable communitieswhich stand to lose the most from a long-term strategy of indiscriminate shutdown -hang in the balance. controlling infectious disease outbreaks: lessons from mathematical modelling differential effects of pandemic (h n ) on remote and indigenous groups virus genomes reveal factors that spread and sustained the ebola epidemic the disconnect between individual-level and population-level hiv prevention benefits of antiretroviral treatment a critique of geoffrey rose's 'population strategy' for preventive medicine where have all the heart attacks gone? poverty and child health in the united states health system, public health, and economic implications of managing covid- from a cardiovascular perspective not a luxury: a call to maintain sexual and reproductive health in humanitarian and fragile settings during the covid- pandemic on the limits of the precautionary principle key: cord- - qqrn w authors: lanteri, charlotte; mende, katrin; kortepeter, mark title: emerging infectious diseases and antimicrobial resistance (eidar) date: - - journal: mil med doi: . /milmed/usz sha: doc_id: cord_uid: qqrn w introduction: the infectious disease clinical research program’s (idcrp) emerging infectious diseases and antimicrobial resistance (eidar) research area is a department of defense (dod) clinical research capability that is responsive and adaptive to emerging infectious disease (eid) threats to us military readiness. among active-duty and other military health system (mhs) beneficiaries, eidar research is largely focused on evaluating the incidence, risk factors, and acute- and long-term health effects of military-relevant eids, especially those caused by high-consequence pathogens or are responsible for outbreaks among us military populations. the eidar efforts also address force health protection concerns associated with antimicrobial resistance and antimicrobial stewardship practices within the mhs. methods: the eidar studies utilize the approach of: ( ) preparing for emergent conditions to systematically collect clinical specimens and data and conduct clinical trials to assist the military with a scientifically appropriate response; and ( ) evaluating burden of emergent military-relevant infectious diseases and assessing risks for exposure and development of post-infectious complications and overall impact on military readiness. results: in response to the ebola virus epidemic in west africa, the idcrp partnered with the national institutes of health in developing a multicenter, randomized safety and efficacy study of investigational therapeutics in ebola patients. subsequently, the eidar team developed a protocol to serve as a contingency plan (epicc-eid) to allow clinical research activities to occur during future outbreaks of viral hemorrhagic fever and severe acute respiratory infections among mhs patients. the eidar portfolio recently expanded to include studies to understand exposure risks and impact on military readiness for a diversity of eids, such as seroincidence of non-lyme disease borreliosis and coccidioides fungal infections among high-risk military populations. the team also launched a new prospective study in response to the recent zika epidemic to conduct surveillance for zika and other related viruses among mhs beneficiaries in puerto rico. another new study will prospectively follow u.s. marines via an online health assessment survey to assess long-term health effects following the largest dod shiga toxin-producing escherichia coli outbreak at the u.s. marine corps recruit depot-san diego. in cooperation with the trauma-related infections research area, the eidar research area is also involved with the multidrug-resistant and virulent organisms trauma infections initiative, which is a collaborative effort across dod laboratories to characterize bacterial and fungal isolates infecting combat-related extremity wounds and link lab findings to clinical outcomes. furthermore, the eidar team has developed an antimicrobial resistance and stewardship collaborative clinical research consortium, comprised of infectious disease and pharmacy specialists. conclusions: the eidar research area is responsive to military-relevant infectious disease threats that are also frequently global public health concerns. several new eidar efforts are underway that will provide combatant command surgeons, infectious diseases service chiefs, and other force health protection stakeholders with epidemiological information to mitigate the impact of eids and antimicrobial resistance on the health of u.s. military service members and their dependents. and the u.s. army medical research institute of infectious diseases. in addition, department of defense (dod) overseas labs can leverage opportunities to conduct surveillance for emerging threats, as well as conduct large scale vaccine or therapeutic trials. one significant gap; however, was having a clinical platform in dod medical facilities to conduct multi-center clinical research on potential emerging threats and biodefense. therefore, in , the infectious disease clinical research program (idcrp) leadership decided to add a research area related to biodefense and emerging infectious diseases (bd/ eid). this nascent program has evolved, perhaps more significantly than any other research area since its establishment. in addition to the aforementioned gap in the dod clinical centers, the decision to add this new research area was based on other strategic needs. the military's focus on agents that threaten national security or military personnel on the battlefield may be different than civilian preparedness response efforts for bioterrorism or pandemics. this research area helped align the program with key dod and non-dod stakeholders to enhance the idcrp's ability to respond to new or re-emerging threats and support military clinical capabilities to study biodefense countermeasures. agents causing viral hemorrhagic fevers, including ebola and marburg viruses, have been targets of vaccine and therapeutics development in the dod. viral hemorrhagic fevers have threatened combat, peacekeeping, and training operations for decades in areas such as the balkans (dobrava virus), korea (hantaan virus) and the south pacific (dengue virus) and, as a result, have motivated the development of preventive measures. consequently, the first study in the bd/eid program area was a collaboration between the national institute of allergy and infectious diseases (niaid) vaccine research center and military investigators on the safety and immunogenicity of ebola and marburg dna vaccines, assessed at a wrair collaborative field site at makerere university in kampala, uganda. the results showed that, given separately or together, both investigational dna vaccines, one encoding ebola virus zaire and sudan glycoproteins and one encoding marburg virus glycoprotein, were well-tolerated and elicited antigen-specific humoral and cellular immune responses. these findings contributed to the accelerated development of more potent ebola virus vaccines that encode the same wildtype glycoprotein antigens that were tested during the - ebola virus disease outbreak in west africa. , in , the largest-ever ebola virus outbreak was recognized in the west african countries of guinea, liberia, and sierra leone. the dod responded with providing military members to build ebola treatment units, provide logistics support, and diagnostics teams and assays in-country under operation united assistance. multiple different investigational countermeasures were employed during the outbreak and niaid led a multi-center group to prioritize the potential countermeasures and develop a randomized controlled trial to study the most promising options. idcrp investigators participated in the prioritization effort and the idcrp's team at the walter reed national military medical center served as the only dod site participating in the protocol: a randomized controlled trial of the monoclonal antibody zmapp for treatment of ebola virus disease. the study enrolled patients and demonstrated improved outcomes from ebola virus disease in those receiving zmapp, although the results did not meet pre-specified criteria for statistical significance. as a naturally occurring infection, smallpox was the target of a successful global eradication campaign in the s and vaccination of civilian populations ceased in the s. nevertheless, because of ongoing concerns of bioterrorism, the u.s. military continues to vaccinate at-risk operational forces, some healthcare workers, and service members in korea. during the last decade, over one million individuals received the vaccine, which is made from the vaccinia virus. in addition to conferring protection against smallpox, the vaccinia virus demonstrated promise as a vaccine-delivery system, inducing immunity to pathogens such as hiv. as a result, another early study assessed host immune factors that might attenuate the response to vaccinations. because of its potential use in hiv candidate vaccines, investigators at the idcrp and the military hiv research program, with support from the u.s. military vaccine agency, evaluated the potential impact of pre-existing immunity to vaccinia with the use of vaccinia-vectored vaccines in a cell-based infection model. using longitudinal sera from military personnel who had been vaccinated, the investigators found that serum antibody responses to smallpox vaccination did not persist over extended periods of time (e.g., years post-vaccination), suggesting that prior vaccination for smallpox might not interfere with the effectiveness of novel vaccines using vaccinia virus as a vector. within the idcrp, there is a broad intersection of emerging infections across multiple other idcrp research areas, such as the skin and soft-tissue infections and trauma-related infections. , in particular, research has focused on the epidemiology, risk factors, and prevention of community-associated methicillin-resistant staphylococcus aureus skin and softtissue infections in military personnel, as well as emergent trauma-related infections, such as invasive fungal wound infections. in line with the president's executive order for combating antibiotic-resistant bacteria, idcrp also led the way to identify and assess the public health impact of multidrug-resistant gonococci. other early investigations into eid threats assessed a range of disease agents, such as rickettsia parkeri in the tidewater region of virginia shortly after it was identified as an endemic disease in that region. as the bd/eid program continued to evolve, it was renamed as the emerging infectious disease & antimicrobial resistance (eidar) research area in and continues to grow to encompass a broad clinical research portfolio, covering a diversity of military-relevant eids. infectious disease threats to military forces remain high due to deployment worldwide, frequently to areas with limited medical and public health infrastructure. novel respiratory pathogens, such as mers-cov and avian influenza strains, pose significant risk to military populations. the - ebola outbreak in west africa exposed vulnerabilities and delays in responding to research opportunities, and led to the recognition that the u.s. needs the capability to study infectious disease outbreaks in real time, as well as being included in routine public health response planning. the rapid deployment of large numbers of military personnel into disease endemic areas heightens their risk for acquiring infectious diseases. in these settings, the conditions and circumstances (i.e., crowding and inadequate access to hygiene) facilitate potential for disease transmission to other susceptible individuals. the return of military forces from diseaseendemic areas also imposes a significant disease risk to other military personnel, military dependents, as well as the general public, by creating an avenue for the importation of novel pathogens into the united states and increasing the risk of localized outbreaks and major epidemics. the impact of monitoring for and describing the epidemiology and clinical characteristics of novel respiratory pathogens with pandemic potential among military personnel is necessary to ensure a timely, comprehensive epidemiologic, immunologic, virologic, and clinical characterization of the initial cases of an eid in what may be a mounting epidemic or pandemic. the idcrp has prided itself on responding rapidly to new research opportunities; however, the time it takes to draft and receive regulatory approval for new protocols may lead to missed opportunities during an outbreak, especially for shortlived events. with this in mind, in , the idcrp established the epidemiology, immunology and clinical characteristics of emerging infectious diseases with pandemic potential (epicc-eid) protocol, which was designed to fill critical needs by providing military hospitals with a plan to respond rapidly to public health crises/outbreaks of diseases with severe outcomes with potential to spread to the civilian populations in the united states and abroad. the objectives of this protocol are to characterize the epidemiologic, laboratory, immunologic, and clinical characteristics of infections caused by high-consequence pathogens, such as severe acute respiratory infections or viral hemorrhagic fevers, among individuals presenting for care at mtfs to inform effective patient care. this protocol is intended to reduce the response time to facilitate collaborative research partnerships for interventional therapeutic trials, vaccines, or new diagnostic assays for a novel respiratory pathogen or viral hemorrhagic fever as part of a whole of government approach. the eidar research area directs studies in response to the global health security agenda and the national security strategy requirements for preparedness and response to infectious disease outbreaks. as discussed above, the epicc-eid protocol provides the mhs with a unique capacity for preparedness in facilitating systematic collection of clinical specimens and data at mtfs to support the military with a scientifically appropriate response. in addition, eidar supports studies investigating the disease burden, risk factors, and clinical outcomes associated with emerging and/or reemerging pathogens responsible for causing outbreaks of disease affecting u.s. military populations. recently, zikv emerged as a major public health crisis, with the world health organization in february declaring zikv-related congenital abnormalities a public health emergency of international concern. the u.s. military service members deploying to disease endemic areas where the outbreak was occurring (primarily in south america) or stationed in puerto rico were also at risk for zikv exposure. given limitations on the availability of laboratory testing, u.s. (and dod) policy precludes testing of asymptomatic men for diagnosis of zikv infection. to date, there have been confirmed zikv cases in the mhs, primarily in deployers and travelers to puerto rico and south america. following the zikv outbreaks, there was a recognized need for establishing means for conducting active surveillance of zikv (and related arboviruses, such as dengue and chikungunya) among mhs beneficiaries in a disease-endemic location to better prepare for any subsequent re-emergence of these diseases. to this end, the eidar team, in collaboration with the wrair viral diseases branch, developed a prospective protocol to conduct surveillance of zikv and related arboviral infections among active-duty service members and their dependents presenting with symptoms at the rodriguez army health clinic in puerto rico. this study will allow early detection of outbreaks among mhs beneficiaries on the island, assessment of impact on military readiness, and ready reporting to force health protection officials. chikungunya virus is another mosquito-borne infectious disease threat to deployed u.s. military service members that is caused by an rna virus related to dengue and zikv, and sometimes is misdiagnosed since these viruses share similar clinical signs and common geographic distribution. chikungunya infection causes febrile illness, often characterized by debilitating joint pain and, in some cases, progresses to severe rheumatic disease. while the majority of patients recover fully, some cases are associated with chronic issues of joint pain; eye, neurological and heart complications; and gastrointestinal complaints. an eidar virtual cohort study is underway, involving analysis of data extracted from the disease reporting system internet by collaborators at the navy marine corps public health center epidata center and the mhs data repository, to evaluate short-and longterm health outcomes, disability, and healthcare utilization attributable to chikungunya infection in mhs beneficiaries. in addition to vector-borne tropical infectious diseases, diarrheal disease is another major threat to u.s. military operations worldwide; however, further investigation is merited to determine the potential long-term health consequences of severe gastrointestinal infections. the impact on military medical readiness of diarrheal illness (travelers' diarrhea) encountered during overseas deployments is a well-characterized force health protection issue and is a major focus for prevention and treatment research within the idcrp deployment and travel-related infection research area. [ ] [ ] [ ] in contrast, less is known about the deleterious health consequences associated with outbreaks of enteric diseases among military populations at installations within the continental united states. moreover, mounting evidence reported in the literature, primarily from epidemiological studies among civilian populations impacted by diarrheal disease outbreaks, suggests post-infectious sequelae (medical complications observed following infection) is a growing concern. - shiga toxin-producing escherichia coli (stec) infection, a major cause of foodborne illness in the united states and associated with consuming undercooked beef, is linked to life-threatening complications manifesting in the acute phase of infection as severe hemorrhagic colitis and hemolytic uremic syndrome, as well as lesser known sequelae emerging months to years later. in response to the u.s. military's largest outbreak of stec (nearly cases) which occurred at the u.s. marine corps recruit depot-san diego in the fall of , a new eidar protocol was developed to investigate long-term health impact of stec infection through a -year follow-up online surveybased study assessing clinical outcomes. the overall objective is to determine the incidence of post-infectious sequelae, including functional bowel disorders (irritable bowel syndrome, dyspepsia, constipation), osteoarticular symptoms (reactive arthritis and avascular necrosis), and renovascular disease (hypertension and chronic kidney disease) in marines identified as stec cases during the outbreak relative to nonill matched controls. a series of analytic modeling approaches will be used to develop a risk model health outcomes risk score to determine how comorbidities, demographics, and other factors affect risk for developing post-infectious sequelae. this health outcomes risk score could be a force health protection tool for identifying individuals at greatest risk for long-term complications in military populations affected by future diarrheal illness outbreaks. the eidar portfolio also supports studies among u.s. military populations to identify the exposure risk to pathogens encountered within the continental united states. specifically, there are two ongoing retrospective studies involve laboratory analyses of dod serum repository specimens from service members to evaluate the burden of military-relevant infectious diseases: newly emergent non-borrelia burgdorferi tick-borne borrelia bacterial infections causing lyme disease and related syndromes at u.s. military training installations and coccidioides fungal infection at the high-risk disease endemic naval air station lemoore. findings from these studies will inform if future investigations into protective measures, novel therapeutics, or improved diagnostics are warranted to protect service members from these pathogens. the eidar research area aims to be increasingly responsive to addressing clinical research gaps informative to shaping force health protection policy. recent strategic partnerships with the armed forces health surveillance branch global emerging infections surveillance section and the uniformed services university of the health sciences (usu) center for global health engagement have been critical to aligning eidar research efforts with geographic combatant command surgeons' requirements for addressing the threat of regional infectious diseases affecting military operations. these and other partnerships with key dod stakeholders will continue to advance the operational relevance of eidar work. antimicrobial resistance is a serious health threat worldwide. new forms of antibiotic resistance have emerged over the past decades and can spread rapidly with some pathogens becoming resistant to multiple types and classes of antimicrobials. [ ] [ ] [ ] [ ] [ ] colonization with and infections caused by multidrug-resistant organisms (mdros) appear common and have a significant impact on military populations. [ ] [ ] [ ] [ ] [ ] in addition, mdro infections further complicate the care of wounded warriors, are associated with high morbidity and mortality, and add substantial and avoidable costs to the healthcare system due to prolonged and costlier treatments, longer hospital stays, and additional patient visits. the idcrp has had a long interest in studying antimicrobial resistance in several of its research areas. as a result, eidar research on mdros and infections caused by these organisms overlap with several other idcrp research areas, including trauma-related infections, deployment and travel-related infections, and sexually transmitted infections research areas. , , in alignment with the president's launch of the executive order for combating antibiotic-resistant bacteria, eidar efforts address force health protection concerns associated with antimicrobial resistance (amr) and filling clinical knowledge gaps related to best practices for antimicrobial stewardship programs (asps) within the mhs. one such major effort is the trauma infectious disease outcomes study (tidos) multidrug-resistant and other virulent organisms (mdr/vo) trauma infections initiative, which is a collaborative effort across dod laboratories with expertise in wound microbiology and infections (including usu, brooke army medical center, u.s. army institute of surgical research, wrair, and nmrc). the mdr/vo trauma infections initiative was established to investigate the combat trauma wound microbiology and infections linked to well-characterized clinical data and outcomes to expand our understanding of the complex microbiology inherent within combat wounds. through the tidos mdr/vo initiative, several analyses have been performed to examine microorganisms collected from combat casualties from iraq and afghanistan, assess antimicrobial resistance, and evaluate associations with clinical outcomes. patients colonized or infected with pathogens having in vitro resistance are reported to have more co-morbidities, longer hospital stays prior to infection, and increased exposure to antibiotics. each of these factors can independently influence clinical outcomes regardless of in vitro susceptibilities. therefore, understanding patient comorbidities is important when assessing the impact of in vitro resistance on outcomes, along with the development and prevention of infection. comorbidities may differ in a military population compared to the general public, especially in combat-related trauma patients and, thus, may affect outcomes differently in this population. the impact of in vitro resistance in a military population has not been evaluated. to address this clinical knowledge gap, an eidar retrospective study is investigating association between phenotypic in vitro bacterial resistance, patient comorbidities and outcomes in antimicrobial-resistant bloodstream infections (ar-bsis) in adult dod beneficiaries, utilizing data extracted from the mhs data repository. analyses are underway of microbiology and clinical data from~ , cases to describe the demographics and risk factors of mhs patients who develop ar-bsis. results from this study will help direct mhs resources to more effectively prevent and plan care for these patients. antibiotic use is a crucial factor leading to antibiotic resistance. up to half of all antibiotics prescribed are not needed or are not effective as prescribed, increasing the risk of bacteria becoming resistant to those antibiotics. , antibiotic misuse also contributes to adverse drug reactions in patients and increased healthcare costs. thus, there is an urgent need to ascertain further clinical knowledge on optimal and appropriate antibiotic use to inform policies that form the basis of hospital asps. the eidar team leveraged the idcrp's extensive clinical research network, which includes active-duty investigators located at mtfs worldwide, to develop an amr/asp collaborative clinical research consortium, comprising infectious disease and pharmacy specialists from army, navy, and air force mtfs. to date, the consortium performed a landscape review of asp efforts within the mhs and identified clinical evidence gaps to be addressed by the group through multisite studies. one ongoing effort of the consortium is creating a knowledge, attitudes, and practices survey to identify trends and practices driving antimicrobial prescribing patterns among mhs healthcare providers, with the aim of generating findings informative to making recommendations for improving asp practices and training within the mhs to support optimal practices in managing microbial infections. the eidar research area was established to ensure the idcrp remained nimble and responsive to studying new and emerging disease threats to military populations in a constantly evolving landscape. in addition to the specific efforts within eidar, the eidar team will continue to partner with other idcrp research areas, as well as external collaborators, to achieve the goal of mitigating the impact of military-relevant eids, especially high-consequence pathogens and mdr infections, on military readiness. newer efforts such as the epicc-eid protocol, stec-short and long-term health effects, zikv epidemiology, and amr efforts, will continue to advance the idcrp's military operational relevance. emerging infections: microbial threats to health in the united states emerging infectious diseases in : years after the institute of medicine report safety and immunogenicity of ebola virus and marburg virus glycoprotein dna vaccines assessed separately and concomitantly in healthy ugandan adults: a phase b, randomised, double-blind, placebo-controlled clinical trial efficacy and effectiveness of an rvsv-vectored vaccine in preventing ebola virus disease: final results from the guinea ring vaccination, open-label, clusterrandomised trial (ebola ca suffit!) ebola outbreak in west africa operation united assistance: infectious disease threats to deployed military personnel a randomized, controlled trial of zmapp for ebola virus infection immunization healthcare branch. information paper, smallpox disease and smallpox vaccine: defense health agency humoral immunity to primary smallpox vaccination: impact of childhood versus adult immunization on vaccinia vector vaccine development in military populations executive order -combating antibiotic-resistant bacteria detecting rickettsia parkeri infection from eschar swab specimens research as a part of public health emergency response world health organization. who director-general summarizes the outcome of the emergency committee regarding clusters of microcephaly and guillan-barre syndrome armed forces health surveillance branch a: years in of chikungunya clinical vaccine development: a historical perspective a scoping review of published literature on chikungunya virus diarrhoea during military deployment: current concepts and future directions military importance of diarrhea: lessons from the middle east german outbreak of escherichia coli o :h associated with sprouts chronic sequelae of e. coli o : systematic review and meta-analysis of the proportion of e. coli o cases that develop chronic sequelae the epidemiology, microbiology and clinical impact of shiga toxin-producing escherichia coli in england shiga toxin-producing escherichia coli infection prevention: carbapenem-resistant klebsiella pneumoniae associated with a long-term -care facility -west virginia complete sequence of a novel -kilobase plasmid carrying bla(ndm- ) in a providencia stuartii strain isolated in afghanistan centers for disease control and prevention: notes from the field: hospital outbreak of carbapenem-resistant klebsiella pneumoniae producing new delhi metallo-beta-lactamase centers for disease control and prevention: notes from the field: new delhi metallo-beta-lactamase-producing escherichia coli associated with endoscopic retrograde cholangiopancreatography -illinois carbapenemase-producing enterobacteriaceae bacteriology of war wounds at the time of injury infection-associated clinical outcomes in hospitalized medical evacuees after traumatic injury: trauma infectious disease outcome study multidrug-resistant bacterial colonization of combat-injured personnel at admission to medical centers after evacuation from afghanistan and iraq phenotypic and genotypic changes over time and across facilities of serial colonizing and infecting escherichia coli isolates recovered from injured service members carbapenem-resistant enterobacteriaceae and the correlation between carbapenem and opportunities and obstacles in the prevention of skin and soft-tissue infections among military personnel after the battlefield: infectious complications among wounded warriors in the trauma infectious disease outcomes study biomedical response to neisseria gonorrhoeae and other sexually transmitted infections in the united states military the acute respiratory infection consortium: a multi-site, multi-disciplinary clinical research network in the department of defense fluoroquinolone usage and resistance in the us military health system the commonality of risk factors for nosocomial colonization and infection with antimicrobial-resistant staphylococcus aureus, enterococcus, gram-negative bacilli, clostridium difficile, and candida immune response to traumatic injury: harmony and discordance of immune system homeostatis vital signs: improving antibiotic use among hospitalized patients antimicrobial resistance we are indebted to our dedicated study team of idcrp investigators, clinical research managers, clinical research coordinators, laboratory personnel, and data management staff for their hard work and contributions to the success of our projects. key: cord- -av vt r authors: alwashmi, meshari f. title: the use of digital health in the detection and management of covid- date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: av vt r digital health is uniquely positioned to enhance the way we detect and manage infectious diseases. this commentary explores the potential of implementing digital technologies that can be used at different stages of the covid- outbreak, including data-driven disease surveillance, screening, triage, diagnosis, and monitoring. methods that could potentially reduce the exposure of healthcare providers to the virus are also discussed. in december of , hospitals began to report cases of unidentified pneumonia among patients with a history of exposure to the huanan seafood market in wuhan, hubei, china. researchers rapidly isolated a novel coronavirus (sars-cov- , also referred to as covid- ) from confirmed infected pneumonia patients [ ] . attracting great attention nationally and worldwide, confirmed cases of covid- exceeded those of severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers). as of april , confirmed cases of covid- had exceeded , , cases and , fatalities. the world health organization (who) has recently declared covid- as both a pandemic and public health emergency of international concern. during the outbreak of ebola and severe acute respiratory syndrome (sars), digital health (dh) demonstrated its potential in detecting and fighting global epidemics [ ] [ ] [ ] . dh is defined as technology that, "connects and empowers people and populations to manage health and wellness, augmented by accessible and supportive provider teams working within flexible, integrated, interoperable, and digitally-enabled care environments that strategically leverage digital tools, technologies, and services to transform care delivery" [ ] . recently, a significant number of dh efforts have emerged because of the unprecedented global strain of covid- on healthcare systems. this article reveals that digital technologies can be used at different stages of the covid- outbreak, including data-driven disease surveillance, screening, triage, diagnosis, and monitoring. methods that could potentially reduce the exposure of healthcare providers to the virus will also be discussed. the review aims to guide further development in dh to improve infectious disease control. the who defines public health surveillance as, "the continuous, systematic collection, analysis, and interpretation of health-related data needed for the planning, implementation, and evaluation of public health practice" [ ] . advancements in information technology and information sharing is giving rise to a new field known as infodemiology. infodemiology is defined as, "the science of distribution and determinants of information in an electronic medium, specifically the internet, with the ultimate aim to inform public health and public policy" [ ] . the allen institute for artificial intelligence (ai) is currently offering free access to a collection of machine-readable literature that includes information regarding the group of coronaviruses [ ] . the allen institute database currently contains more than , articles, of which , are full-text publications. combining this database with other unstructured data from websites or social media can be used to expand our knowledge further regarding the early detection and containment of future outbreaks of covid- and other emerging infectious diseases. online surveillance-mapping tools, such as the surveillance and outbreak response management and analysis system (sormas) [ ] , as well as healthmap [ ] , have the potential to improve the early detection of infectious diseases in comparison to traditional epidemiological tools [ ] . sormas and healthmap are currently being used for the surveillance of covid- . similarly, bluedot's outbreak risk software, a modern epidemiological tool, was reported as the first organization to reveal news of the outbreak [ ] . both medical devices and wearables have the potential to be repurposed to detect emerging patterns that are indicative of disease outbreaks. for example, fitbit devices have been used to inform timely and accurate models of population-level influenza trends [ ] . additionally, smart thermometers have provided a novel source of information for influenza surveillance and forecasting [ ] . colubri et al. [ ] used machine learning to harmonize several data sets from the ebola virus epidemic to provide informed access to evidence-based guidelines. these guidelines were then incorporated in the ebola care guidelines app [ ] . many of these lessons and models can be re-applied to develop a similar app for covid- . the app has the potential to include real-time updates of evidence-based guidelines during a global pandemic to inform the general population and healthcare providers. the integration of real-time updates into electronic medical records can also act as a dependable resource for practicing healthcare providers. the current covid- outbreak has spread internationally, which has prompted the who to demand the detection and management of suspected cases at points of entry into a country [ ] . screening travelers based on flight or cruise origin and travel history for cases of covid- could allow individuals to receive the necessary treatment sooner and may limit the spread of the disease. the use of technology has the potential to screen travelers based on symptoms and travel history. for example, taiwan integrated its national health insurance database with its immigration and customs database to create a "big data" resource for analytics [ ] . the database was used to classify travelers' infectious risks and it generated real-time alerts during clinical visits to aid in case identification [ ] . it can also be utilized to test patients for covid- who had previously tested negative for influenza; one covid- case was confirmed from patients who had already undergone influenza screening [ ] . during the sars pandemic, many countries instituted border measures to control the outbreak [ ] . several researchers stated that thermal image scanning has the potential to enhance screening for infectious diseases [ ] [ ] [ ] . a mass temperature screening solution utilizing ai was developed to reduce the need for manual temperature screening. integrated health information systems and kronikare are currently piloting a screening solution that automatically screens and identifies patients with symptoms such as fever [ ]. sun et al. [ ] recommend using a microwave radar to capture heart rate and respiratory rate to enhance the accuracy of mass screening. additional research is needed to validate and develop mass temperature screening solutions. in response to the viral outbreak, many countries have transitioned to virtual medical care. online tools are used to prioritize the treatment of patients based on the severity of their condition. digital stethoscopes, such as those from tytocare [ ] and eko [ ] , could enhance the quality of remote medical exams. such dh interventions aim to prove early access to healthcare and reduce the risk of transmission to other patients and healthcare providers in the hospital setting. many countries and health institutions are offering free triage telehealth assessments for covid- . the telehealth assessments provide patients with access to websites or mobile apps, which consist of a short survey regarding the patient's current condition. the survey includes questions about age, symptoms, and travel history. based on their results, the respondents will be provided with tips, asked to visit a nearby mobile covid- testing site or hospital, or become connected digitally with a healthcare provider. furthermore, health-focused chatbots, such as buoy health [ ] and lark health [ ] , can also help individuals interpret their symptoms and suggest appropriate next steps. survey results could potentially be integrated with electronic medical records to assure continuity of care. following digital triage, patients could benefit from an at-home diagnostic service. similar to over-the-counter genetic or urinary tract infection tests, patients could receive a test kit via mail. the use of a drone delivery method could also be considered as a potential and efficient solution to ensure both a timely diagnosis and patient confidentiality. some test kits may require laboratory analysis [ , ] , while other tests could utilize a smartphone to assist in the interpretation of test results [ ] . if results are positive, patients could receive a virtual consultation to explain the next steps. additionally, all positive results should be communicated and reported to the appropriate agency. at-home diagnostic test kits seem promising and have the potential to reduce the pressure on the healthcare system. however, the united states food and drug administration stated that as of march , there had been no authorization for the use of an at-home diagnostic tool for covid- [ ] . computed tomography (ct) images are currently being used to confirm cases of covid- [ ] . researchers were able to develop a deep learning model that can accurately detect covid- and differentiate it from community-acquired pneumonia and other forms of lung disease [ ] . the deep learning model can also be used remotely by medical professionals outside of the epidemic areas. furthermore, significant advancements in dh, specifically in the field of personalized medicine, have evolved in recent years. researchers are currently working on developing rapid diagnostic tools, vaccines, and medications to cure and limit transmission of covid- [ ] . a patient's measurements can be directly transmitted to healthcare providers or other monitoring entities through the use of remote monitoring technology. remote monitoring technologies can connect wirelessly to networks via bluetooth, wifi, or cellular connection. an extensive body of literature exists regarding the use of dh in the remote monitoring of chronic diseases [ , ] . the same concept could also be applied to the monitoring of infectious diseases. remote monitoring can be used to monitor individuals exposed to covid- as well as close contacts of the individual. remote monitoring can also be used to monitor the exposure of healthcare providers and high-risk patient populations. in essence, similar technology infrastructure currently used by remote monitoring programs can also be used to incorporate a thermometer for monitoring patients that are suspected of having covid- . the sense followup ebola app has an automatic alert system for temperature readings ≥ • c for individuals receiving follow-up care [ ] . a similar feature could also be incorporated in future covid- apps. furthermore, the app could pair with advanced thermometers that allow continuous and real-time monitoring of changes in body temperature [ , ] . other dh interventions have the potential to provide unique data to help us understand the possible effects of covid- on patients with comorbidities. steinhubl et al. [ ] studied the use of a wearable, wireless "band-aid" sensor to monitor patients exposed to the ebola virus. additionally, hexoskin repurposed biometric shirts that are capable of continuously measuring vital signs, including temperature, respiration effort, and cardiac activity, to better understand the evolution of covid- and its effects on lung function [ ] . the use of data from glucometers among patients with diabetes could also be used as an objective indicator of infection, as high glucose levels correlate with signs and symptoms of infection [ ] . infectious respiratory diseases, such as covid- , have the potential to worsen symptoms of pre-existing lung disease, and thus exacerbate the use of emergency medications. increased use of inhaled emergency medication can be detected using a smart inhaler [ ] . as researchers continue to work on vaccines and methods of treatment for covid- , the primary measure of containment is the interruption of human-to-human transmission. contact tracing is the process of identification and follow-up of individuals who have been in contact with a person confirmed to have been infected with covid- . traditional paper-based methods of contact tracing during the ebola outbreak have been proven to be insufficient. such methods caused incomplete identification of contacts and delays in contact tracing steps, such as the identification of contacts involved in suspected cases that required isolation [ ] . our smartphones are increasingly unlocking the power of ai and machine learning to provide accurate and real-time insight into various aspects of healthcare. smartphones can utilize gps or bluetooth technologies for contact tracing purposes. although contact tracing may seem challenging, previous epidemics have been effectively controlled through contact tracing and isolation initiatives [ , ] . to assist in covid- contact tracing, a mobile app called tracetogether is currently being used in singapore [ ] . the app uses bluetooth technology to identify individuals that have been in close contact with patients who have been diagnosed with covid- . healthcare providers are considered a high-risk group for contracting covid- [ ] . the aim of dh implementation during a global pandemic is to reduce the risk of transmission to healthcare providers. the technology applications mentioned above have the potential to reduce transmission by minimizing face-to-face contact between clinicians and patients. furthermore, dh interventions enable healthcare providers to fight the global pandemic, even if they are practicing self-isolation measures or working remotely. both aiva [ ] and deloitte assistant [ ] have created an ai-enabled patient communication solution that allows patients to request assistance, via amazon alexa or google home, without the need to press the traditional call bell button. such interventions have the potential to reduce transmission because healthcare providers may be able to respond to many of the patient's needs without having to enter the patient's room. thus, potentially reducing the frequency of a healthcare provider's exposure. it is important to note that the dh implementation process is likely to be challenging and resource-intensive. for example, the lack of homogenous interventions poses a significant challenge in applying dh interventions. the lack of homogeneity leads to variations in the nature of dh interventions and data collection methods. such differences could limit model generalizability and limit understandings of the effectiveness of dh. governments will need to work with all experts and stakeholders to embed secure dh interventions into practice while maintaining the privacy and confidentiality of patients. it is also important to consider that some countries may not have the technological infrastructure to support dh. furthermore, there will be a significant proportion of the population who will not have access to technology or internet connectivity. this commentary provides valuable insights regarding various dh interventions that can be implemented to enhance the detection and spread of infectious diseases, such as covid- . this information may help a variety of stakeholders-including epidemiologists, healthcare professionals, and policymakers-who are planning to use dh to tackle infectious diseases. the majority of dh interventions have already been developed for other infectious diseases, such as ebola, sars, and the flu. however, many governments and health systems have been slow in adopting these technologies. government, professional associations, and health organizations should take an active role in dh adoption. the united nations established the panel on digital cooperation to address challenges in the digital age and propose modalities for working cooperatively across sectors, disciplines, and borders, to address challenges in the digital age [ ] . this panel could work closely with the who to help address the challenges of implementing digital health in the context of infectious diseases. these organizations could help in addressing the digital divide among countries with limited technological infrastructure. this can be accomplished by sharing the research and development protocols and source codes, similar to sromas [ ] and colubri et al. [ ] . additional research is required to further assess the effectiveness of dh in detecting and managing arising infectious diseases. in addition, cost-effectiveness analysis is required to assess the impact of dh on healthcare resources. digital health provides an opportunity to use real-time data to improve the prevention and control of the rapidly changing nature of epidemics. recent sars, h n , and ebola outbreaks offer many lessons about the use of dh for public health emergencies. these learnings can be transferred to new effective technologies to enhance our response against the covid- pandemic. dh has the potential to strengthen our preparedness for the next pandemic. we need to have these tools locked and loaded for our next war against infectious disease. a novel coronavirus from patients with pneumonia in china precision global health-the case of ebola: a scoping review assessing the concepts and designs of mobile apps for the management of the - west africa ebola outbreak: 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screening for infectious diseases in humans fever screening and detection of febrile arrivals at an international airport in korea: association among self-reported fever, infrared thermal camera scanning, and tympanic temperature thermal image scanning for influenza border screening: results of an airport screening study remote sensing of multiple vital signs using a cmos camera-equipped infrared thermography system and its clinical application in rapidly screening patients with suspected infectious diseases check your symptoms in real time digital disease management & prevention platform. lark health innovative at-home health testing modern primary & urgent care. carbon health at home medical testing kits update: fda alerts consumers about unauthorized fraudulent covid- test kits relationship to duration of infection potential rapid diagnostics, vaccine and therapeutics for novel coronavirus ( -ncov): a systematic review abu ashour, w. the effect of smartphone interventions on patients with chronic obstructive pulmonary disease exacerbations: a systematic review and meta-analysis impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials remote sensing of vital signs: a wearable, wireless "band-aid" sensor with personalized analytics for improved ebola patient care and worker safety type diabetes and its impact on the immune system use of a mobile application for ebola contact tracing and monitoring in northern sierra leone: a proof-of-concept study tracetogether-behind the scenes look at its development process. govtech singapore a novel coronavirus outbreak of global health concern virtual health assistant. aiva health the high-level panel on digital cooperation funding: this research received no external funding. the authors declare no conflict of interest. key: cord- - kvaduoq authors: mcmahon, meghan; nadigel, jessica; thompson, erin; glazier, richard h. title: informing canada's health system response to covid- : priorities for health services and policy research date: - - journal: healthc policy doi: . /hcpol. . sha: doc_id: cord_uid: kvaduoq to inform canada's research response to covid- , the canadian institutes of health research's institute of health services and policy research (ihspr) conducted a rapid-cycle priority identification process. seven covid- priorities for health services and policy research were identified: system adaptation and organization of care; resource allocation decision-making and ethics; rapid synthesis and comparative policy analysis of the covid- response and outcomes; healthcare workforce; virtual care; long-term consequences of the pandemic; and public and patient engagement. three additional cross-cutting themes were identified: supporting the health of indigenous peoples and vulnerable populations, data and digital infrastructure, and learning health systems and knowledge platforms. ihspr hopes these research priorities will contribute to the broader ecosystem for collective research investment and action. afin d'éclairer la réponse du canada en matière de recherche sur la covid- , l'institut des services et des politiques de la santé (isps), des instituts de recherche en santé du canada, a mené un processus d'identification rapide des priorités en matière de recherche. sept priorités pour la recherche sur les politiques et services de santé liée à la covid- ont ainsi été identifiées : adaptation du système et organisation des soins; éthique et prise de décision en matière d' allocation des ressources; synthèses et analyses comparatives rapides des résultats et des politiques d'interventions face à la covid- ; personnel de la santé; soins virtuels; conséquences à long terme de la pandémie; et engagement de la population et des patients. trois thèmes transversaux supplémentaires ont été identifiés : soutien à la santé des peuples autochtones et des populations vulnérables; données et infrastructures numériques; et systèmes de santé apprenants et plateformes de connaissances. l'isps souhaite que ces priorités de recherche contribuent à enrichir l'écosystème de l'investissement et des initiatives de recherche collective. the coronavirus disease (covid- ) pandemic has had devastating consequences worldwide and revealed the underpreparedness of systems (health, political, economic) to respond swiftly. health systems are grappling with how to rapidly mobilize, organize and deploy resources to provide effective covid- care while simultaneously attempting to reorganize the provision of non-covid- care effectively and safely. the government of canada' s top priority throughout the pandemic has been to keep canadians healthy and safe (government of canada ), and one mechanism to achieve this has been to mobilize canada' s health research community to respond to the covid- crisis. as canada' s federal health research funder, the canadian institutes of health research (cihr) has played an active role in the covid- health research response along with its tri-council partners, canada' s broader health and science portfolios, provincial and territorial research funders and health systems, charities and hospitals, as well as local, academic, private sector and other funders. on february , , cihr, together with funding partners, launched its first rapid research response funding opportunity (cihr a), which resulted in funded research projects totalling $ . million (cihr b). the government of canada then allocated an additional $ million to cihr in march for a second round of rapid research funding (cihr c). beyond these, cihr has led several other covid- funding calls, including the covid- clinical epidemiology research rapid response, world health organization solidarity trial and opportunities focused on mental health and substance use. additional investments are under way to further support research teams with expiring grants, to maintain income support for trainees whose research has been delayed by the pandemic and to support the retention of research staff at universities and health research institutes. the cihr' s institute of health services and policy research (ihspr) is one of virtual institutes and one of many players in the health research ecosystem. ihspr is aiming to create a shared understanding of health services and policy research (hspr) covid- priorities across the country to help align resources with the most important evidence needs for policies and interventions that contribute to improved health and health system outcomes. ihspr identified covid- priorities for hspr through a rapid and iterative process that included literature and media scans, an environmental scan of covid- research priorities in other countries (table ) , input from leading hspr experts in canada and a brief survey of the hspr community. data from these sources were triangulated, analyzed and summarized to distill core and cross-cutting hspr covid- priorities and validated with the institute advisory board. detailed methods are available in appendix , available online at longwoods.com/content/ . ihspr' s rapid-cycle priority identification process resulted in seven core priority areas and three cross-cutting themes relevant for research and policy analysis within and across each priority. research that informs system adaptation and organization of resources and care in the covid- era is urgently needed as many sectors have been ill-equipped to meet covid- care needs, with community care homes (including long-term care [ltc] homes) being hardest hit. areas of focus include hospitals and the primary, home and community care (including ltc) sectors (basky ; cadogan and hughes ; coccolin et al. ; glauser ; grabowski and joynt maddox ; lin et al. ) . predictive and optimization modelling is needed to inform system resilience, resource planning, disease testing and surveillance systems, patient flow and continuity of care. also critically needed is research that both evaluates innovations in the organization and delivery of care that were catalyzed as a result of the covid- pandemic, and analyzes the policy options and levers that would support the scale and spread of these innovations. covid- has revealed shortages of capacity and resources, including personal protective equipment (ppe) and, in some settings, intensive care unit (icu) beds and ventilators (emanuel et al. ; gostin et al. ; phua et al. ; ranney et al. ; truog et al. ; . non-urgent surgeries have been cancelled, and as reopening commences, decisions will be made about prioritization for care. research, policy analyses and ethical frameworks are required to inform allocative decision-making and the consequences of those decisions (antommaria et al. ; emanuel et al. ; fritz et al. ; gostin et al. ; rosenbaum a) . further analyses are needed to examine the ethical implications of restrictive public health and social distancing measures, use of technology and data for contact tracing and the equity consequences for vulnerable populations (laupacis ; mazumder et al. ; mulligan et al. ; smith and judd ; van dorn et al. ; wang and tang ) . there has been considerable heterogeneity across countries and canadian jurisdictions in the response and timing of policies enacted to flatten the curve (e.g., social distancing, school closures) and reopen society (e.g., non-essential services, return to school). rapid knowledge syntheses and comparative policy analyses are needed to document and understand responses, analyze their intended and unintended consequences and develop response options to inform future planning and preparedness. as covid- -related policies have been enacted at municipal, provincial/territorial and federal levels and implemented by systems, organizations and individuals, analyses will require appropriate targeting to reach policy and decision-makers with differing mandates, accountabilities and contexts (gibney ). the healthcare workforce has needed to adapt quickly to the covid- landscape. enormous pressure due to a lack of ppe, high workloads and safety concerns (xiong and peng ) has added considerable stress to healthcare workers (greenberg et al. ; zhou et al. ), many of whom had high levels of burnout prior to the pandemic (canadian medical association ). research is needed to analyze how the healthcare workforce was deployed and supported to provide covid- care, understand the facilitators and barriers to a coordinated and effective response (basky ; coccolin et al. ; fraher et al. ; lake ) , evaluate the impacts on covid- and non-covid- care, and consider the strategies and policies that could be implemented to improve workforce planning, capacity and safety. research is also needed to understand the role that family and other informal caregivers played, the supports and resources they used and/or needed, the impact that covid- had on their health and mental health and the policy options for supporting informal caregivers in the future. covid- crystallizes the importance of virtual care to meet patient needs and reduce the risk of disease transmission (bhatia et al. ; greenhalgh et al. ; hollander and carr ; webster ) . research is needed to analyze and compare the extent and type of virtual care used across jurisdictions, who provided and received virtual care and for what purpose, the payment policies implemented and the intended and unintended consequences of expanded use. as well, research that analyzes the impact of virtual care on key outcome measures such as access, utilization, continuity, quality and safety, equity, cost and health is important to inform the design of future virtual care models. to respond to covid- , healthcare resources were rapidly redeployed, reducing access to routine and ongoing care and leaving many with cancelled referrals, tests and procedures (angelico et al. ; carter et al. ; rosenbaum b; salako et al. ). due to fear of infection, many canadians did not seek healthcare even when needed. certain sectors, such as ltc, and certain populations, such as the homeless and incarcerated, were disproportionately impacted. gendered consequences include balancing work, childcare and household duties, which fall disproportionately on women (kitchener ; minello ) . longitudinal research is needed to study the long-term and far-reaching effects of the pandemic on health, health equity and health system outcomes, as well as the post-covid- health, social and economic policies that are created. policy analysis is imperative to shed light on why the consequences emerged, why they had a disproportionate impact across sectors and populations and to inform future policy development. citizen response to public health advice and restrictions has profound effects on viral transmission and therefore the covid- pandemic itself. research and policy need to meaningfully engage with the public and patients, including vulnerable and at-risk populations. priorities need to be established through understanding the experience and perspectives of the public and patients with the pandemic, the covid- and non-covid- care received (or not received), caregiver needs and supports and the supports and tools needed as the crisis subsides (e.g., mental health supports and spiritual care). public and patient engagement is also critical for decision-making about removing restrictions and what the "return to the new normal" should look like (immonen ). through ihspr' s rapid-cycle priority identification process, three cross-cutting themes were identified that intersect each of the seven priority areas: . supporting the health of indigenous peoples and vulnerable populations: first nations, inuit and métis populations are at high risk of covid- acquisition and severe disease in both rural/remote and urban settings. people who are homeless, incarcerated and living in poverty are also at high risk. hspr is needed to analyze the impacts of covid- on indigenous peoples and vulnerable populations and the factors that exacerbated those impacts. policy research is also needed to inform the development of post-pandemic health and healthcare policies that are culturally safe and grounded in indigenous knowledges. . data and digital infrastructure: covid- has highlighted the importance of timely access to data for researchers, decision-makers and front-line providers to inform policy and care delivery decisions. access for researchers to linkable data from diverse sources (e.g., covid- testing data linked with clinical and administrative data, consumer wearables, social media and patient reports) and digital infrastructure is needed to enable rapid analysis of the impacts and evidence-informed response strategies. covid- has also revealed critical gaps in data. for example, the lack of race and ethnicity data, and measures and data about racism, hinders researchers' ability to decipher differential impacts of the pandemic and inform targeted policy responses, which risks further exacerbating existing inequities in health and outcomes. . learning health systems and knowledge platforms: knowledge platforms are needed that provide seamless and rapid access to high-quality research studies, synthesize the volumes of research that covid- has spurred and tailor the evidence in ways that meet the diverse needs of policy and decision-makers. covid- illuminates the ability of healthcare delivery systems (e.g., a health authority) and organizations (e.g., a hospital or ltc home) to use covid- and other data to support real-time decision-making, foster continuous learning and evidence-informed planning and implement policies and interventions across the system. ihspr is one of many organizations in a broader ecosystem that funds research and is dedicated to contributing to the covid- research response. the priorities identified in this paper are intended to help align collective hspr investment, activity and collaboration in areas where covid- evidence is critically needed and where it has the most potential to improve the lives of people, the health of populations and the performance of healthcare systems. as shown in table , the seven priorities are not unique to the canadian context and conform closely with priorities identified in other jurisdictions. common priorities include: clinical and health system innovations in the delivery, management and organization of care; deployment of the healthcare workforce and addressing workforce needs; access to care by vulnerable populations; digital health and technological innovations; addressing mental health needs and challenges; and patient and community engagement. canada' s hspr community has capacity, expertise and leadership in each of these common priorities. this presents an opportunity for canadian researchers to leverage the community' s strengths to lead or engage in international hspr collaborations and cross-jurisdictional research. who is best poised to conduct the research? the impact of research on the covid- response will be enhanced if the interdisciplinary nature of the hspr field is harnessed. the health policy and care delivery solutions needed are multifaceted and will need to draw on the interdisciplinary expertise of canada' s health services researchers, epidemiologists, political scientists, economists, lawyers, healthcare providers, embedded scientists, policy and decision-makers and patient partners. their skills in evaluation, health law and policy analysis, health economics, clinical and health informatics, organization and management of care, implementation science and other domains are critical to generating evidence in the identified priority areas that accounts for the complexity of the context and problem and has the potential for real-world impact. who is the covid- -related hspr intended for? given ihspr' s mandate, the research evidence is intended to inform covid- -related policy making within ministries of health and professional associations and decision-making within health authorities and healthcare delivery organizations. the goal is to equip health policy and decision-makers with evidence they can use to design and implement effective policies, programs and interventions that improve the organization, delivery and outcomes of healthcare. the cihr covid- rapid response and mental health knowledge synthesis funding calls included an objective to provide evidence to inform decision-making and the health system response. the calls also ensured that peer review criteria assessed the impact of the research and the quality of the proposed knowledge translation plan, but did not require decision-maker involvement on the research teams (cihr c; cihr d). to inform policy and decision-making, effort will be needed once the research is funded to meaningfully engage decision-makers in the work and develop effective knowledge mobilization strategies. ihspr is committed to this effort. in addition to relevant research as a lever for change, impact within several of the identified priorities will require the use of legislative, regulatory, funding and other policy levers. for example, addressing the covid- crisis that has played out in canada' s ltc homes (brown ) will require timely and relevant research evidence, plus attention to accreditation, regulation and inspection, staffing levels and working conditions, government funding levels and the expansion of public reporting efforts to include measures such as staffing and ownership type. importantly for the hspr community, these covid- priorities are not intended to serve as the sole focus of ihspr or cihr. although cihr' s spring project grant competition was delayed until summer and the institutes' strategic funding initiatives • knowledge translation approaches, practices and platforms applied to inform both population-level and targeted mental health and substance use responses during the pandemic • population-based interventions to reduce potential mental health and substance use impacts of covid- • targeted interventions to address the mental health and substance use issues and needs of high-risk groups • innovative surveillance and monitoring in both the general canadian population and among high-risk groups to assess mental health and substance use needs and system transformations (including the use of learning health systems, other modes of service delivery [e.g., virtual care], alternate remuneration models, etc.) world health organization (who ) • national institute on drug abuse: how potential overcrowding of emergency departments and health services will impact the treatment of opioid overdoses and opioid use disorder • national institute on aging: studies in prehospital, emergency or critical care settings to improve screening, risk stratification, care delivery decisions, resource allocation and clinical outcomes for older adults exposed to covid- ; evaluating strategies used by health systems to reallocate resources, rapidly train practitioners, communicate preventive practices and maintain adherence to public health and clinical guidelines, with a particular interest in those who serve high-risk groups (e.g., nursing homes) and resulting racial, ethnic or regional disparities in access/care • national institute of mental health: studies on the impact (e.g., access, quality, and clinical outcomes) of state, local, federal and guild-specific guidelines and policies around telehealth services and of changes in those policies, with specific attention on the risks and benefits of relaxing those guidelines or policies • national institute on minority health and health disparities: examine the effects of the covid- outbreak on disparities in healthcare utilization and health outcomes among medically and socially vulnerable populations • national cancer institute: impact on cancer-related care delivery due to the covid- pandemic • national institute of biomedical imaging and bioengineering: the nibib is seeking applications to develop life-saving technologies that can be ready for commercialization within one to two years; for example: rapid point-of-care and home-based testing/diagnostics; digital health platforms and models that integrate data, assess risk and provide illness surveillance and management tools • national institute on alcohol abuse and alcoholism: what workforce development and deployment strategies are needed to address emerging challenges in mental health/alcohol use disorder treatment during the pandemic? *not exhaustive; intended to be a snapshot only. within ihspr, we are actively engaged in cihr' s broader covid- efforts (including our work to identify hspr covid- priorities) and will continue to finalize our next five-year strategic plan and initiate planning for large-scale funding programs in areas that align with our institute' s mandate. the implications of this for the hspr community are important: there is space and resources for researchers to lead covid- -related research, pivot their existing research to contribute to covid- and/or continue with their core hspr programs of research. in the face of a pandemic that has placed tremendous demand on resources and generated a significant human toll, hspr is critically needed to inform the path forward. research that evaluates the health system response, analyzes and informs policy options and identifies how to improve the design and delivery of health services is essential for many reasons, including successful navigation out of the current pandemic, improving health system preparedness for future outbreaks and ensuring that the canadian healthcare system that reopens is stronger, resilient, and more accessible, more equitable and of higher quality than the one that existed before the onslaught of covid- . health systems respond to covid- : priorities for rapid-cycle evaluations high-impact studies evaluating health system and healthcare professional responsiveness to covid- (r ) the covid- outbreak in italy: initial implications for organ transplantation programs ventilator triage policies during the covid- pandemic at u.s. hospitals associated with members of the association of bioethics program directors all hands on deck as cases of covid- surge virtual health care is having its moment -rules will be needed how covid- overwhelmed canada's long-term care system on the frontline against covid- : community pharmacists' contribution during a public health crisis canadian institutes of health research (cihr). a. operating grant: canadian novel coronavirus (covid- ) rapid research canadian institutes of health research (cihr). b. canadian rapid research funding opportunity results canadian institutes of health research (cihr). c. operating grant: covid- canadian institutes of health research (cihr). d. operating grant: knowledge synthesis: covid- in mental health and substance use physician health and wellness in canada: connecting behaviours and occupational stressors to psychological outcomes health system, public health, and economic implications of managing covid- from a cardiovascular perspective surgery in covid- patients: operational directives fair allocation of scarce medical resources in the time of covid- ensuring and sustaining a pandemic workforce ethical anchors and explicit objectives: ensuring optimal health outcomes in the covid- pandemic whose coronavirus strategy worked best? scientists hunt most effective policies proposed protocol to keep covid- out of hospitals responding to covid- : how to navigate a public health emergency legally and ethically postacute care preparedness for covid- : thinking ahead managing mental health challenges faced by healthcare workers during covid- pandemic video consultations for covid- . virtually perfect? telemedicine for covid- the views of patients and the public should be included in policy responses to covid- women academics seem to be submitting fewer papers during coronavirus. the lily how effective response to covid- relies on nursing research working together to contain and manage covid- what can early canadian experience screening for covid- teach us about how to prepare for a pandemic? geriatric care during public health emergencies: lessons learned from novel corona virus disease (covid- ) pandemic . covid- rapid response rolling call the pandemic and the female academic race-based health data urgently needed during the coronavirus pandemic. the conversation covid- ): information for nih applicants and recipients of nih funding patient-centered outcomes research institute (pcori). . covid- targeted pfa intensive care management of coronavirus disease (covid- ): challenges and recommendations. the lancet respiratory medicine critical supply shortages -the need for ventilators and personal protective equipment during the covid- pandemic facing covid- in italy -ethics, logistics, and therapeutics on the epidemic's front line the untold toll -the pandemic's effects on patients without covid- upheaval in cancer care during the covid- outbreak telehealth for global emergencies: implications for coronavirus disease (covid- ) covid- : vulnerability and the power of privilege in a pandemic the toughest triage -allocating ventilators in a pandemic covid- exacerbating inequalities in the us challenges to the system of reserve medical supplies for public health emergencies: reflections on the outbreak of the severe acute respiratory syndrome coronavirus (sars-cov- ) epidemic in china combating covid- : health equity matters canada and covid- : learning from sars world health organization (who). . a coordinated global research roadmap: novel coronavirus focusing on health-care providers' experiences in the covid- crisis. the lancet global health the role of telehealth in reducing the mental health burden from covid- -online now. the search for improving value in canadian healthcare the authors would like to thank emma kaplan, ihspr communications and events officer, for her help with the media scan that informed this paper. the authors would also like to thank the members of the ihspr institute advisory board for their insightful and invaluable contributions, comments and feedback regarding the priorities. key: cord- -iluqwwxs authors: lessler, justin; cummings, derek a. t. title: mechanistic models of infectious disease and their impact on public health date: - - journal: american journal of epidemiology doi: . /aje/kww sha: doc_id: cord_uid: iluqwwxs from the s through the s, lowell reed and wade hampton frost used mathematical models and mechanical epidemic simulators as research tools and to teach epidemic theory to students at the johns hopkins bloomberg school of public health (then the school of hygiene and public health). since that time, modeling has become an integral part of epidemiology and public health. models have been used for explanatory and inferential purposes, as well as in planning and implementing public health responses. in this article, we review a selection of developments in the history of modeling of infectious disease dynamics over the past years. we also identify trends in model development and use and speculate as to the future use of models in infectious disease dynamics. from the s through the s, lowell reed and wade hampton frost used mathematical models and mechanical epidemic simulators as research tools and to teach epidemic theory to students at the johns hopkins bloomberg school of public health (then the school of hygiene and public health) ( , ) . though never published by reed and frost (versions of the model were eventually published by their students ( , ) ), their model was one of the first mechanistic models of infectious disease transmission, and at a time long before digital computing, they may have been the first to use simulation methods to understand the epidemic process. reed and frost were pioneers in the study of infectious disease dynamics using mechanistic models, a field of epidemiology that has developed in parallel with the associative statistical models and methods of causal inference that dominate much of epidemiologic research. over the past century, mechanistic models have played an essential role in shaping public health policy, the way we study interventions aimed at controlling infectious diseases, and the theory on which disease control is based. mechanistic models differ from traditional statistical models such as regression models because their structure makes explicit hypotheses about the biological mechanisms that drive infection dynamics. such hypotheses range from simple representations of the time it takes to complete some part of the disease process (e.g., sartwell's lognormal representation of the incubation period ( )) to complex agent-based models that attempt to explicitly represent social interactions of people in an entire country ( , ) or even the world ( ) . regardless of scale, approach, and complexity, these models have more of the flavor of models in physics than the statistical models that are used in other branches of epidemiology, and in many cases they can be used to predict the effectiveness of hypothetical interventions in controlling disease spread. perhaps the first mechanistic model of infectious disease transmission used in assessing intervention strategies was a mathematical model of malaria transmission developed and refined by ronald ross in a series of papers published between and ( ) ( ) ( ) , pre-dating the work of reed and frost by decades. this model had a direct and powerful message for public health: malaria could be controlled and even eliminated through mosquito control, even if the vector could not be completely eliminated. ross used his theoretical framework to develop and advocate for multiple indices, including the prevalence rate and the entomological inoculation rate ( ) , that could effectively characterize the intensity of transmission in an area and identify goals for control. in the wake of the founding of the global malaria eradication program by the world health organization, george macdonald ( ) extended ross's work in order to justify the use of insecticide as a tool for global malaria eradication ( ) . in particular, he showed that increasing daily mosquito mortality from % to % would be adequate to eliminate malaria even in locations with the highest transmission intensities in africa. mechanistic models continue to play an important role in the fight against malaria. the work of ross and macdonald looms large to this day, with a recent review finding that the majority of models published since depart from central hypotheses of the ross-macdonald model in only a few key assumptions, if any ( ) . although there are numerous instances over the past century in which mechanistic models have contributed to the control of a single disease (see figure for some examples), their larger contribution may be in our general understanding of disease control. the prime example is the concept of herd immunity and the critical vaccination threshold. herd immunity is the indirect protection offered to members of the population susceptible to the disease (i.e., not immune and with the potential to be infected) by the immunity of surrounding individuals, and the critical vaccination threshold is the percentage of the population that must be vaccinated in order for the introduction of an infectious case to not spark an epidemic ( ) . to estimate the critical vaccination threshold, we must first understand one of the most critical concepts of infectious disease dynamics, the basic reproductive number, r . r is the number of cases that a single infectious individual is expected to cause in a fully susceptible population. this concept was first introduced in demography and underwent significant development by lotka while on a visit to the johns hopkins university school of hygiene and public health in (see heesterbeek ( ) for a full history of the development of r in infectious disease). although this value does vary by setting, for many pathogens it is remarkably consistent across contexts and serves as a rough quantification of pathogen transmissibility. based on dynamic models, it has been shown that if we vaccinate a proportion of the population equivalent to − /r , then the pathogen will fail to spread in that population. this is the critical vaccination threshold, and it has helped to set vaccination goals for a number of diseases, particularly when elimination is the goal. however, the dynamics of vaccines in real populations are complex, and mechanistic models have helped us to understand what to expect after changes in vaccination policy. for instance, immediately after the introduction of a vaccine or improvement in vaccination rates, a disease may appear to be eliminated from a population. however, this long honeymoon period may be followed by a large, resurgent, outbreak that bigger than the yearly epidemics seen before the introduction of vaccination (though the cumulative number of cases is still less than what would have been seen without vaccination) ( ) . these results have helped public health officials to understand that initial apparent vaccine successes may not last, as well as what to expect after introducing a new vaccine. mechanistic models have also been used to understand the optimal age range for vaccination campaigns ( , ) , how such campaigns should be timed ( ) , and how best to use vaccines when supplies are limited ( , ) . models have also been used to design active response strategies for vaccine use, including ring vaccination strategies such as those implemented in the smallpox eradication campaign ( ) . models were also used to assess strategies to respond to a bioterrorist release of smallpox in the early part of the st century and were influential in setting policy for response ( ) ( ) ( ) ( ) . one counterintuitive prediction of mechanistic models is that in rare cases, increased population immunity from vaccination can actually increase the incidence of severe disease. the poster child for the phenomenon is congenital rubella syndrome (crs). for most people, rubella infection causes a relatively minor infection characterized by fever and rash; however, when pregnant women are infected during the first trimester of pregnancy, it cause crs, which results in severe complications of pregnancy including congenital disorders and death of the fetus ( ) . because vaccination increases the average age of infection (by decreasing the hazard of infection), a vaccination program that does not achieve sufficient coverage can increase the number of pregnant women who are infected, thereby increasing incidence of crs ( ) . this is not simply a theoretical concept; although there have been no sustained increases in the incidence of crs (in part due to the public health response), both costa rica and greece experienced transient increases in crs burden after rubella vaccination ( , ) . in light of the threat of crs, mechanistic models have played an important role in setting world health organization recommendations for the introduction of a rubella vaccine. these recommendations encourage countries to wait to introduce the vaccine until measles vaccination rates (measles and rubella vaccines are usually given together) are high enough to guarantee a reduction in crs cases and to strongly consider vaccination campaigns in women of childbearing age before the vaccine is introduced ( ) . vaccination is only of a suite of control measures. another that is of particular importance in the control of macroparasite infections is mass drug administration. a key difference between microparasite and macroparasite dynamics is the huge variation in transmission potential of human hosts, with some individuals experiencing huge pathogen loads that contribute disproportionately to transmission within populations ( ) . here, strategies have taken an eye toward reducing overall population burdens of macroparasites, including targeting those with the highest burdens. theoretical explorations of the impact of heterogeneity in transmissibility have helped inform interventions and aided in the development of theory exploring the impact of heterogeneities in microparasites ( ) . (aids). ron brookmeyer ( ) used the incubation period distribution of hiv to "back calculate" the number of hiv infections that must have occurred over the previous course of the epidemic and predict the number of future hiv/aids cases in those already infected with hiv. he thereby linked an observable quantity (the number of aids cases) with an unobservable one (the number of people living with hiv). longini et al. ( ) then fit a more mechanistic model of disease progression to data from hiv-infected individuals in the united states army, achieving similar results by explicitly representing the biological process. when attempting to estimate global mortality from measles infection, simons et al. ( ) used a state-space model (i.e., a hidden markov model) which linked an underlying model of measles epidemic dynamics (the process model) with nationally reported measles incidence via an observation model ( ) . they thereby were able to estimate the extent to which national reports underestimated measles cases by reconciling these reports with what was likely given birth rates and a known epidemic process. planning for so called "black swans," which are unlikely but catastrophic events, is essential to ensuring security and population health. the prime example of an infectious disease black swan is the influenza pandemic, which is estimated to have killed - million people in years ( ) . governments and policy makers depend on simulations built on mechanistic models to decide the extent of these threats and what can be done to confront them. for the past decade and a half, there have been ongoing concerns that one of several strains of influenza a that have been known to infect humans from domestic poultry (h n , h n , etc.), might develop the ability to transmit efficiently in humans and cause a major pandemic. h n strains are seen as particularly concerning because of their high case fatality rate and the substantial increase in the number of human cases (particularly in southeast asia) that started in ( ) . independent teams of disease modeling experts developed sophisticated agent-based models of potential emergence events to determine whether effective antiviral agents could be used to contain an emerging influenza at the source ( , ) . these models showed that under reasonable expectations of the transmissibility of an emerging influenza (i.e., r in the . - . range), containment was possible, though perhaps not practical, as it would require the deployment of millions of courses of antiviral medication, very early detection of the disease, and rapid response. in parallel work, groups considered how the impact of a pandemic could be mitigated in the united states if the initial containment attempt was unsuccessful ( ) ( ) ( ) . the efforts of independent groups showed that something more than social-distancing measures (e.g., school closure, case isolation) would be needed to control a pandemic and that effective antivirals could help. in part on the basis of this work, the united states and other countries decided to stockpile antivirals to combat a future pandemic, a decision that has since been criticized by some ( ) . however, these criticisms have been focused on concerns about the efficacy of the stockpiled antiviral drugs ( ) rather than the results of the modeling work itself. the question of the probability of h n influenza evolving to become transmissible in humans has itself been the focus of mechanistic modeling ( ) . after research groups had identified different sets of mutations to the h n virus that would be sufficient to allow airborne transmission in a mammalian host ( , ) , russell et al. ( ) developed a mathematical model of the within host dynamics of influenza evolution. although the authors were unable to confidently estimate the probability of the emergence of a pandemic h n strain because of uncertainties about the underlying biological processes involved, they were able to identify the biological factors on which this probability would most strongly depend and recommend studies (e.g., deep sequencing of viral samples from h n -infected hosts) that might help to develop more precise predictions. there has been considerable debate surrounding the ethics of gain-of-function experiments for h n influenza ( ) , but if such experiments are to be justified, they must provide us a way to have advanced warning of a coming pandemic, a task that may only be possible through mechanistic models. however, to be successful, these models will require substantial additional theoretical work on how viral evolution interacts with the distribution of immunity in the population. in the event that an outbreak of an emerging disease does occur, mechanistic models are one of the first tools used to characterize the threat and plan a response. when a pandemic influenza strain emerged in , it was critical to quickly assess whether it had the potential to cause illness with high rates of fatality, like the virus that emerged in the pandemic of , or was a more mild disease, akin to what was seen in the pandemics of and . initial assessments relied heavily on dynamic models of a variety of types, including phylogenetic techniques paired with demographic models, models based on the probability of the observed number of introductions of pandemic h n into populations outside of mexico, analysis of epidemic curves, and the results of detailed investigations of early outbreaks ( , ) . analyses by a number of groups quickly showed that the emergent pandemic h n virus was behaving very much like alreadycirculating strains, and although it was still potentially a significant public health threat, it was unlikely to have a qualitatively different impact on mortality or morbidity than circulating influenza strains. in addition to its role in the response to the influenza pandemic, mechanistic modeling has played a role in the response to most of the emerging disease threats of this century, from foot and mouth disease in the united kingdom ( ), to severe acute respiratory syndrome coronavirus ( ) , to middle east respiratory syndrome coronavirus in saudi arabia ( ) , to ebola in west africa ( ) . the last of these shows both the power of mechanistic approaches and the dangers of its misuse. in the summer and fall of , the number of ebola cases in west africa was continuing to grow, and it was unclear how severe the epidemic would eventually become. to address this issue, as well as the threat of spread to other countries, a number of modeling exercises were conducted (e.g., gomes et al. ( ) ). of particular note was a model released by the centers for disease control and prevention that predicted that, without further intervention, . million cases of ebola would occur in liberia and sierra leone by mid-january ( ). this did not come to pass, and although the authors noted that such long-term projections were tenuous, the media and many in the public health community made much of this number. of course interventions and behavior change did occur, but the authors had also made tenuous assumptions about how the populations of liberia and sierra leone mix together, essentially treating each country as a homogenous entity. in contrast, the world health organization ebola response team, who also made projections based on an unconstrained epidemic, declined to forecast further than months into the future ( ), and though theirs was a moderate overestimate of total cases, they avoided publishing any panic-inducing overestimations (they projected approximately , cases by november , ; approximately , actually were reported by that point) ( ) . forecasting the course of disease spread is difficult to do well, particularly in the context of an active response. it also may be the least of what mechanistic approaches to disease epidemiology have to offer. the aforementioned work, particularly that of the world health organization ebola response team, also characterized important aspects of ebola's natural history and epidemiology, including its basic reproductive number (r ), the decline in r over the course of the epidemic, the incubation period, and the serial interval, properties of the disease that will be important to understand should it re-emerge. mechanistic and mathematical approaches aid not only in the response to particular diseases but also in illuminating basic epidemiologic principles and important parameters that dictate whether a novel (or existing) pathogen can be controlled. in a paper, fraser et al. ( ) confronted the question of why severe acute respiratory syndrome coronavirus was successfully contained, whereas influenza, hiv, and numerous others were not. they were particularly interested in the effectiveness of the tools available when first confronting a novel pathogen: contact tracing, isolation, and quarantine. they presented evidence that a critical determinant of the controllability of a pathogen is the amount of transmission that occurs before symptom onset, expressed by their parameter θ. pathogens that had a low proportion of all transmission occurring before symptom onset are easier to control because symptomatic individuals can be targeted with isolation or pharmaceuticals before they transmit to others. although forecasting is difficult, particularly in the response to an emerging disease threat, it remains a major goal of the disease-modeling community. because disease reporting is often delayed, forecasting includes not only projections into the future but also "now casting" of incidence based on more readily available information. this has led to a number of approaches in which models have been used to either process a data stream that is a proxy of the data of interest but available more quickly (e.g., google flutrends) ( ) or in analyses of ongoing outbreaks to assess (with available data) what might be the current situation given the limitations of the observation process and temporal lags in both reporting and outcomes being generated (e.g., calculating case fatality rates for the severe acute respiratory syndrome coronavirus and middle east respiratory syndrome coronavirus outbreaks when many patients had yet to resolve) ( , ) . at a larger time horizon, several efforts have attempted to forecast the impact of interventions on future incidence. one of the most successful was a project that forecasted the impact of respiratory syncytial virus immunization campaigns on the temporal pattern of incidence in the united states. using mechanistic transmission models, pitzer et al. ( , ) made detailed predictions of the impact of vaccination on the multiannual dynamics of rotavirus, as well as the impact of the vaccine on genotype circulation. these forecasts of broad qualitative impacts of interventions are critical tests of models. detailed prospective predictions of changes that will occur with changes in health policy, which are then validated, will provide the best evidence of the utility of mechanistic models in the future. dependent happenings is the term coined by ronald ross ( ) to capture the fact that for infectious diseases, an individual's risk of infection depends on the disease status of those around them ( ) . this presents challenges for trial design and the interpretation of observational studies. cluster randomization and adjustment for intra-class correlation can be used to account for this effect in some cases ( ) , but mechanistic models are often useful in trial design or in interpretation of results when cluster randomization is imperfect or impossible. under these conditions, simulations studies have been used to help in study design settings, including vaccine studies ( , ) and combination approaches to hiv prevention ( ) . mechanistic models have been particularly revealing for studies of vaccine effectiveness. for example, a naïve approach would be to consider that all vaccines acted in the same way, providing complete protection for some fraction of the population. however, in reality vaccines may be leaky and provide protection only in some dimensions ( ) . vaccines may prevent infection all together (e.g., the measles vaccine) ( ), offer protection against pathogenic disease but still allow individuals to become infected and transmit the disease (e.g., acellular pertussis vaccines ( )), or only prevent onward transmission of the disease (e.g., transmissionblocking vaccines for malaria ( ) ). in order to anticipate and assess the impact of vaccines once scaled up to widespread use, the specific actions of the vaccine in reducing infection, onward transmission, and disease must be disentangled. these specific mechanisms will contribute differently to the direct, indirect, and total effects of a vaccine. these effects are increasingly targets of inference during trials ( ) , and developments in infectious disease theory have driven development of both inference tools and study design to measure specific impacts ( ) . in emerging outbreaks, simulation models have often been used as the framework to quickly quantitatively compare policy alternatives. the application of these models has yielded results ranging from broad information about the feasibility and potential impact of interventions to detailed recommendations about targeting of interventions. in the foot and mouth disease outbreak of , models were used to determine optimal culling strategies that specified operational details of those strategies, including the timing and spatial extent of culling. even outside of public health crises, infectious disease models play an important role in setting public health policy. cost-effectiveness analyses are often built on mechanistic models of disease spread ( , ) . models can help investigators choose between different intervention strategies, determine the potential of specific interventions, and compare investments across pathogens. infectious disease models play a critical role in incorporating indirect effects that can vary substantially across alternative programs. the design of immunization campaigns against human papillomavirus has to weigh the direct effects protecting women from human papillomavirus infection, as well as indirect protection resulting from immunization of both women and men. the tradeoffs of alternative programs in protecting individuals at risk of the most severe outcomes and those at little risk have been best evaluated in transmission models ( ) . increasingly important is the marrying of mechanistic disease models with operations research by explicitly modeling the logistical constraints on public health intervention. this approach can be key when preparing for outbreaks or bioterrorism, as speed of deployment, hospital capacity, and other logistical factors can severely impact the efficiency of disease containment and its subsequent spread ( , ) . likewise, a logistical analysis can assess the feasibility of novel diseasecontrol strategies, showing whether they are practical as well as efficacious; for instance, an analysis of the feasibility and potential effectiveness of passive immunotherapy in hong kong showed that this intervention could play an important role in controlling a mildly severe pandemic ( ) . as the price of computation drops and we enter the era of "big data," the role of mechanistic models will only increase. a powerful new synergy is the combination of mechanistic models of disease spread with phylogenetic techniques outlining the evolutionary relationship between infecting pathogens. genetic sequence data present samples of pathogens taken from a large population of pathogens both within a host and among all hosts. understanding the impact of different selective pressures on pathogens is inherently a task of population genetics. models of the population dynamics of pathogens have been incorporated into models in order to explain the phylogenetic structure of pathogens. sequence data have been used to infer basic reproductive numbers of pathogens ( , ) , harkening back to lotka's first use of the term to describe replication of organisms. in future work, we expect to see more direct integration of models with data at both population scales, as has been the tradition, and within models of infectious disease host scales. traversing these scales will be a key challenge to the field. targeted funding and the relatively new paradigm (at least for epidemiology) of sanctioning competitions to identify the best methods of disease forecasting continue to in invigorate the field. in the united states, the models of infectious disease agent study and the recently completed research and policy for infectious disease dynamics program have led to well over , publications and continue to invigorate research and training in the field ( , ) . similar initiatives in the united kingdom and other parts of europe, such as that from the medical research council's centre for outbreak analysis and modelling, have also been successful ( ) . competitions such as the national oceanic and atmospheric administration's dengue forecasting project ( ), the defense advanced research projects agency forecasting chikungunya challenge ( ) , and the us center for disease control and prevention's predict the influenza season challenge ( ) require researchers to assess and compare the performances of their models and stand by their predictions in the face of actual events. such initiative should serve to greatly improve the quality and number of models of infectious diseases, but this will only translate into improved public health if it is paired with greater engagement with policy and practice. in limited space, it is impossible to cover every important contribution that mechanistic models have made over the past century, and there is much important work that we have not covered. these contributions range from work showing the potential impact of test-and-treat strategies in hiv control ( ) , to analyses of how to best use a limited supply of cholera vaccines to control disease ( , ) , to fundamental work on the link between demographic characteristics and disease incidence ( ) . these omissions should not be seen as a reflection of the quality of the work, but rather merely as the result of our need to select only a few of many good options. the use of mechanistic models in infectious disease epidemiology has shifted over the course of years. the arc of their use spans beginnings as of a group of statistical and mathematical tools used by epidemiologists to understand a multitude of phenomena, to use and development by an increasingly specialized group of researchers over the course of the th century, to more general use by a broader group of researchers. this arc still bends. at their core, these methods provide frameworks of analysis that can be treated in the same way as other statistical tools of analysis. refinement of methods has led to a theoretical base and application toolkit that allows nonspecialists to analyze and understand infectious disease dynamics with mechanistic models. this broader ecosystem of modelers, which includes methods-focused researchers and public health practitioners, has led to encouraging progress in tying models increasingly to data and to the most salient infectious disease problems facing global health. memoir on the reed-frost epidemic theory a commentary on the mechanical analogue to the reed-frost epidemic model an examination of the reed-frost theory of epidemics some mathematical developments on the epidemic 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implications for the design of control programs superspreading and the effect of individual variation on disease emergence reconstruction and future trends of the aids epidemic in the united states the dynamics of cd + t-lymphocyte decline in hiv-infected individuals: a markov modeling approach assessment of the global measles mortality reduction goal: results from a model of surveillance data tracking measles infection through non-linear state space models updating the accounts: global mortality of the - "spanish" influenza pandemic avian influenza a (h n ) infection in humans containing pandemic influenza at the source strategies for mitigating an influenza pandemic mitigation strategies for pandemic influenza in the united states modeling targeted layered containment of an influenza pandemic in the united states report disputes benefit of stockpiling tamiflu neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis the potential for respiratory droplet-transmissible a/h n influenza virus to evolve in a mammalian host airborne transmission of influenza a/h n virus between ferrets experimental adaptation of an influenza h haemagglutinin (ha) confers respiratory droplet transmission to a reassortant h ha/h n virus in ferrets ethical alternatives to experiments with novel potential pandemic pathogens pandemic potential of a strain of influenza a (h n ): early findings outbreak of pandemic influenza a (h n ) at a new york city school dynamics of the uk foot and mouth epidemic: stochastic dispersal in a heterogeneous landscape transmission dynamics and control of severe acute respiratory syndrome middle east respiratory syndrome coronavirus: quantification of the extent of the epidemic, surveillance biases, and transmissibility who ebola response team. ebola virus disease in west africa-the first months of the epidemic and forward projections assessing the international spreading risk associated with the west african ebola outbreak estimating the future number of cases in the ebola epidemic-liberia and sierra leone world health organization factors that make an infectious disease outbreak controllable detecting influenza epidemics using search engine query data methods for estimating the case fatality ratio for a novel, emerging infectious disease demographic variability, vaccination, and the spatiotemporal dynamics of rotavirus epidemics modeling rotavirus strain dynamics in developed countries to understand the potential impact of vaccination on genotype distributions design and analysis of vaccine studies statistics notes: the intracluster correlation coefficient in cluster randomisation modeling human papillomavirus vaccine effectiveness: quantifying the impact of parameter uncertainty design and evaluation of prophylactic interventions using infectious disease incidence data from close contact groups hptn (popart): a cluster-randomized trial of the population impact of an hiv combination prevention intervention including universal testing and treatment: mathematical model acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model development of a transmission-blocking malaria vaccine: progress, challenges, and the path forward effects of vaccination on invasive pneumococcal disease in south africa a review of typhoid fever transmission dynamic models and economic evaluations of vaccination cost-effectiveness analyses of human papillomavirus vaccination emergency response to an anthrax attack logistical feasibility and potential benefits of a population-wide passive-immunotherapy program during an influenza pandemic evolutionary analysis of the dynamics of viral infectious disease models of infectious disease agent study (midas) about the centre for outbreak analysis and modelling national oceanic and atmospheric administration. dengue forecasting project chikungunya threat inspires new darpa challenge predict the influenza season challenge universal voluntary hiv testing with immediate antiretroviral therapy as a strategy for elimination of hiv transmission: a mathematical model the impact of a one-dose versus two-dose oral cholera vaccine regimen in outbreak settings: a modeling study a simple model for complex dynamical transitions in epidemics on the course of epidemics of some infectious diseases we thank c. jessica metcalf for suggestions and useful discussions.conflict of interest: none declared. key: cord- - hc authors: sullivan, lisa m; velez, amanda a; galea, sandro title: graduate public health education in the post-covid- era date: - - journal: lancet public health doi: . /s - ( ) -x sha: doc_id: cord_uid: hc nan the unprecedented interruption of education due to covid- has accelerated innovation and exacerbated challenges. the recent lancet public health editorial cites education as the most modifiable social determinant of health, and in line with the global education monitoring report, is calling for more inclusive and integrated educational systems in the post-covid- era. , we agree and see an opportunity to redefine the role of graduate education to prepare the next generation of public health professionals. we previously articulated a vision for graduate public health education that is authentic, inclusive, flexible, ongoing, and reflective of changes in societal needs. the covid- pandemic forced difficult transitions, and we suggest three changes that should continue in the future. first, the widespread use of educational technology should continue. new technologies support flexibility with chat functions that allow more reserved students to participate and break-out rooms to promote active learning. second, an explicit embrace of trauma-informed pedagogy is needed. our communities suffered deep and profound losses. the faculty should recognise that students need support and flexibility, just as the faculty are managing their own grief and personal responsibilities. third, the shift from teaching as a solo activity to a more collective enterprise is beneficial. most faculties have learned new technologies together and shared best practices, which results in more cohesive curricula. the transitions caused by the covid- pandemic also highlighted several challenges. the most evident challenge is the growing gap between the educational haves and havenots. some students did not have adequate technology to fully engage remotely, some had unreliable internet, and some had challenging home situations. these issues point to a need to embrace inclusive pedagogy. challenges in the remote teaching environment also remain, including how best to engage students with course content (eg, polling), each other (eg, break-out rooms), and the instructor (eg, real-time feedback). the rapid pace of technological development makes it difficult to stay abreast of opportunities, which can be transformative, without adequate training and support. the successes of the moment, and the challenges that persist, point to three approaches that could be adopted towards better graduate public health education. first, educational leaders should create approaches that allow flexibility. an example is the learn from anywhere approach, which involves a faculty member teaching some students oncampus and other students remotely. the learn from anywhere approach offers flexibility to students with increasingly complex life circumstances, giving them more control over their learning. second, educational leaders must bridge divides. educational approaches should never disadvantage any student. different but equitable options that create positive learning environments, improve outcomes, and set students up for lifelong learning are needed now more than ever. third, it is important to engage with consequential issues of contemporary concern. encouraging students to think critically and helping them to better understand politics, policies, and health inequities in real time supports deeper learning. in the past few months, faculty and students gained a new appreciation for remote and online teaching and learning. it will be crucial not to lose momentum by returning to old habits. instead, public health faculties should embrace adaptability, as graduate schools and programmes of public health will play a now even more crucial role in creating the next generation of public health professionals. the lancet public health. education: a neglected social determinant of health global education monitoring report. inclusion and education peering into the future of public health teaching covid- and us higher education enrollment: preparing leaders for fall key: cord- - gau vmc authors: giorgi, gabriele; montani, francesco; fiz-perez, javier; arcangeli, giulio; mucci, nicola title: expatriates’ multiple fears, from terrorism to working conditions: development of a model date: - - journal: front psychol doi: . /fpsyg. . sha: doc_id: cord_uid: gau vmc companies’ internationalization appears to be fundamental in the current globalized and competitive environment and seems important not only for organizational success, but also for societal development and sustainability. on one hand, global business increases the demand for managers for international assignment. on the other hand, emergent fears, such as terrorism, seem to be developing around the world, enhancing the risk of expatriates’ potential health problems. the purpose of this paper is to examine the relationships between the emergent concept of fear of expatriation with further workplace fears (economic crisis and dangerous working conditions) and with mental health problems. the study uses a quantitative design. self-reported data were collected from italian expatriate workers assigned to both italian and worldwide projects. structural equation model analyses showed that fear of expatriation mediates the relationship of mental health with fear of economic crisis and with perceived dangerous working conditions. as expected, in addition to fear, worries of expatriation are also related to further fears. although, the study is based on self-reports and the cross-sectional study design limits the possibility of making causal inferences, the new constructs introduced add to previous research. the globalization of markets that has taken place in recent decades was a great opportunity for companies to become known and to operate in a wider context (biemann and andresen, ; andresen et al., ) . this phenomenon led to the possibility that many of the managers who served in a national territory could be transferred to foreign countries, characterized by different cultures and work processes (sims and schraeder, ) . however, working globally involves changes in occupational dynamics and in the levels of job complexity, and it also requires great skills of adaptation and adjustment (black et al., ; black and gregersen, ) . most of the researches conducted on adjustment in a foreign country concerned so-called expatriate workers or expatriates (sims and schraeder, ) , who are those workers sent from their own organization to follow projects or to lead company sectors abroad. an expatriate can be properly defined as one who works in a foreign country for a period of at least months (birdseye and hill, ; jones, ; chan et al., ) . however, shorter forms of expatriation also exist, as shown in the present study. supporting expatriates in performing their tasks in a new environment is nowadays essential for companies. accordingly, researchers have studied expatriated performance and adaptation and evaluated the influence of specific practices of human resource management on their behavior. relevant dimensions have been identified (mol et al., ; cheng and lin, ) , such as training, to support expatriates in dealing with different cultural values, unexpected behavioral rules, and language barriers. on the other hand, the dark sides of the expatriation experience have also been studied, such as the possible failure of the assignment, leaving without having finished the task, or psychologically withdrawing and performing worse than they usually would. failure may be particularly expensive in human and monetary terms (baruch, ) . however, adaptation/adjustment may be defined as the comfort degree (or the stress absence) associated with the role of the expatriate (bhaskar-shrinivas et al., ) ; expatriates who fail to face the demands of a job and do not properly adapt to a new environment may experience high levels of stress (perone et al., ) . the scenario of stressors among expatriates seems complex, from the micro-environment and the macro-environment to the mega-environment (lei et al., ) . in particular, according to bhaskar-shrinivas et al. ( ) , work assignments to be carried out abroad lead to greater stress when the following situations occur: (a) when the leader perceives his role as unclear, or rather he does not understand which tasks are actually his and what the company expects from him; (b) when the leader feels he has a low decision latitude; if he does not feel free to make decisions without first having to ask and obtain the green light from his company; (c) if the position is considered too demanding, difficult or new; or in a situation that the leader does not feel up to the task of handling because of lack of experience or lack of capacity; (d) when the manager recognizes that there is a conflict, such as in a case where certain tasks cannot be completed because that would hamper the achievement of other business objectives he is trying to achieve. black et al. ( ) observed that expatriates tend to suffer a greater number of relapses after periods of stress. jones ( ) , in a review, identified some risk factors that could not only adversely affect health, but could also lead to developing fear and anxiety of expatriation: risk of being involved in accidents; quality of living conditions; working conditions; risk of disease contagion; fear of being involved in violence; kidnappings and terrorist acts. these risk factors are analyzed below: -risk of being involved in accidents. this fear is typically supported by the objective evidence that in some countries there are very low driving standards and poor road safety. moreover, in some countries the roads are of low quality. -quality of living conditions. the quality of food and hygiene is one of the most important factors to ensure the adaptation of an expatriate to the new job environment. for example, good water quality cannot be ensured in all countries. drinking poor quality water could cause the development of oral infections or gastrointestinal problems. the same effects can also be produced by eating non-controlled food. as far as lifestyle is concerned, a lack of leisure activities and difficulties in communication (for example, poor internet and telephone functionality) may be a concern. -working conditions. there are higher psychological and physical strains in developing countries, which can inhibit the expatriate's ability to cope with perceived stress and can eventually increase unsafe practices. heavy traffic and low control of industrial gas emissions could also affect the health of expatriates. also, the presence of pristine nature in some working locations might interact negatively with a lower standard of safety and health. -chances of disease contagion. expatriates should be informed on the prevalence of diseases in the host country before their trip or during their stay. the possibility of having specific vaccines would be an important protective factor against possible contagion. however, the fear of contagion from some illness might be always present in some countries. psychological susceptibility to become stressed by the potential contagion also appears important. -fear of being involved in violence, kidnappings, and terrorist acts. this issue, once confined to few world regions, seems now to be more widespread (bader and schuster, ) . given that anxiety could significantly decrease people's psychological well-being and mental health, there is increasing empirical research on the effect of fear in the workplace (mueller and tschan, ) . fear, especially if chronic, may damage, in particular, the immune, the nervous and the cardiovascular systems (shiba et al., ) . the human body may be weakened by states of fear, especially if chronic. in particular, the immune, the nervous and the cardiovascular systems are damaged, but equally, the gastrointestinal tract and the reproductive system are not spared. in particular, the fear may compromise the decoding of emotions and decision making processes, making the subject susceptible to intense emotions and impulsive reactions and, consequently, to making inappropriate actions. fatigue, depression, accelerated aging, and even premature death may be the further consequences of long-term fear (shiba et al., ) . furthermore, the literature shows that expatriate workers have an increased risk of consuming psychotropic and narcotic substances as well as of abusing of psychotropic drugs (aubry et al., ; bianchi et al., ; kaeding and borchers, ) . our study enhanced the literature by being the first to look at a set of important fears among expatriates. in particular, we aimed to find out how the emergence of fear of expatriation, induced by mental health problems, might impact on the expatriate's further fears in the workplace, using data from a survey of italian expatriate workers. building on the stress perspective (lazarus and folkman, ; lazarus, ) , we have, in particular, examined the following issues: how mental health is associated with fear; the relationship between fear of expatriation and fear of economic crisis as well as perceived dangerous working conditions; the mediation of fear with mental health and the development of further fears. we intend to conceptualize fear of expatriation due to the risk factors discussed above. indeed, this study contributes to the literature on expatriates' health by testing an emergent model for the prevention of mental health issues. this paper proceeds as follows. first of all, we present the conceptual model and the derived hypotheses. then, we explain the methodology used. finally, the results and discussion (including limitations and research perspectives) are considered. expatriate workers often experience difficulties in their adjustment to new work and living situations and, consequently, they are at risk of developing mental health problems (costa et al., ; zhu et al., ) . this situation may enhance the fear of violence and of poor living and working conditions during the experience abroad (lazarus and folkman, ) . this fundamental concept is the basis of our conceptual model (figure ) . with this in mind, workers can be severely traumatized not only by actual violence but also from any potential violence . for instance, terrorism is quickly spreading (leistedt, ) . data from the global terrorism database (gtd) of the national consortium for the study of terrorism and responses to terrorism (start) ( ) regarding global terrorism shows that in such attacks relate to countries. in , the worldwide attacks numbered , ( % more than in ), which led to more than , deaths and more than , injured people. the geographical distribution is highly concentrated. sixty percent of these attacks took place in five countries (iraq, india, afghanistan, pakistan, and nigeria), while % of the fatalities caused by terrorism took place in five countries (iraq, nigeria, afghanistan, pakistan, and syria). the strategy of the most developed terroristic groups -e.g., islamic state of iraqi and the levant (isil) and boko haram -not only provides for violent attacks on military or civilian points, but also for kidnapping, torture, and rape. these practices increase the fear of the people -particularly those who are located in the directly involved geographical areas -and of international public opinion. workers with mental health problems might be particularly vulnerable to developing fears of these practices. the use of social media by isil has allowed for the extreme visibility of this organization with a widespread dissemination of its terroristic contents (united states department of state publication bureau of counterterrorism, ) and might increase anxiety in workers with pre-existent mental health problems or stress (solberg et al., ; glad et al., ; paz garcía-vera et al., ) . the context of living and working conditions in the host country is another factor associated with expatriates' psychological well-being. frazee ( ) pointed out that healthcare is one of the main issues for expatriates: more than one-third of international assignments are dissatisfied with the health assistance they receive. the standard of healthcare around the world varies in a very important way. however, discrepancies may exist even among different regions of the same country. in addition, expatriates might be afraid of not receiving an adequate and timely treatment for all types of injury and, moreover, the sanitary conditions might not be good, increasing the risks of contagions or illness. these concerns affect virtually all expatriate workers, but may result in real states of fear in subjects with mental health problems and may generate the acute and chronic worsening of any already existing clinical situation (pierre et al., ; cleary et al., ; wilde and gollogly, ) . hypothesis : mental health problems generate fear of expatriation. the second part of the model is focused on the development of further fears in the workplace. despite the numerous relevant stressors in global assignments, in our conceptual framework we mainly focused on two areas of fear of expatriation. the first is related to violence, intended both as physical and psychological. the second is related to the perceived impeded living and working conditions (including workplace safety, illness contagion, and lifestyle). as already explained, the presence of a pre-existing state of fear or anxiety may enhance the likelihood of negative stimulus to elicit fear. indeed, emotions are specific to the context and imply a person-environment relationship. more specifically, emotions embody a particular theme, reflecting the way the individual sees his/her relationship with the environment in a given situation (lazarus, ) . the fear of expatriation might negatively influence the perception of the safety environment and the anxiety caused by economic crisis. moreover, expatriates are often exported to societies with weaker and less expensive h&s policies (heymann, ) , raising a perception of unsafe working conditions (curcuruto et al., ) . in our model we expect a mediation process of fear of expatriation among mental health and further fears in the workplace. first, mental health problems generate anxiety and fear. fear can impair the formation of long-term memories and can cause damage to certain parts of the brain, such as the hippocampus (besnard and sahay, ) . this can make it even more difficult to regulate fear and can leave a person anxious most of the time. the threats to our security impact our mental wellbeing, whether they are real or perceived, generating multiple fears. hypothesis : mental health problems, through the mediation of fear of expatriation, influence further fears in the workplace: dangerous working conditions and economic stress. this study was conducted in a large international company dealing with technology and services in heavy industry. the expatriate managers employed in this company were all invited to participate in the study. expatriation services in this company are usually in short form. expatriates spend cyclically days outside the workplace (often in platforms or yards located worldwide). the final respondents were employees (response rate = %) working in multiple locations (italy, europe, middle east, asia, africa, australia, etc.). the survey was administered through the corporate intranet, ensuring anonymity, and privacy rules. a video, in which an industrial psychologist and an occupational physician explained the procedure of questionnaire compilation and the survey aims, was also made available through the corporate intranet. the sample consisted of only men in managerial positions. workers were, on average, relatively young: . % years old or younger, . % from to years old, . % from to years old, and only . % were over . regarding job tenure, . % of the participants had worked from to years, . % of participants had worked from to years, . % of the participants had worked from to years, and . % of participants more than years. finally, the majority of employees had long working hours ( . % h per week, . % - h per week, % more than h per week). after collecting some socio-demographic variables, participants completed the scales on fear of expatriation, economic stress, dangerous working conditions and psychological distress. the scales used in this study are described below. fear of expatriation was measured by a new questionnaire, developed by our research group and called fear of expatriation scale (supplementary material). the measure is composed of two dimensions: (a) fear of violence/terrorism -(two items) employees are scared of being subjected to violence/terrorism (e.g., "i am scared of being the object of physical violence -kidnapping, terrorism, etc."); (b) fear of the working and living conditions -(three items) employees are worried about the working and living conditions and about healthcare (e.g., "i am scared of contracting a disease"). the scores were collected, for each dimension, through a fivepoint likert scale (from : "strongly disagree" to : "strongly agree"). as this instrument was developed for this research, we evaluated the construct validity and reliability of the fear of expatriation scale in order to investigate its psychometric properties. we assessed the construct validity (convergent validity and discriminant validity) of the scale by conducting a confirmatory factor analysis (cfa) in order to compare the hypothesized factorial model involving two distinct factorsfear of violence/terrorism and fear of the working and living conditions -with a one-factor model. results showed that the hypothesized two-factor model yielded a good fit to the data (χ [ ] = . , ns; cfi = . ; rmsea = . ; srmr = . ) and outperformed that of the one-factor solution (χ [ ] = . , p < . ; cfi = . ; rmsea = . ; srmr = . ; χ ( ) = . , p < . ), thus supporting the distinctiveness between the two sub-dimensions of fear of violence/terrorism and fear of the working and living conditions. furthermore, standardized regression coefficients of items on each factor were all higher than . (hair et al., ) , thus supporting the convergent validity of the factors (range = . - . ). however, cfa results also indicated that the correlation among latent constructs was higher than . . this therefore suggests that the two dimensions might be best combined on an overall scale of fear of expatriation (kline, ) . accordingly, in our subsequent analyses to test hypotheses and , we considered only the overarching fear of expatriation scale, and not its separate dimensions. finally, internal consistency, which was assessed by the calculation of reliability coefficients (cronbach's alpha), was . , . , and . for the overall fear of expatriation scale, the fear of violence/terrorism dimension and the fear of the working and living conditions dimension, respectively. thus, this indicated good internal consistency of the measure (nunnally, ) . economic stress was measured with the scale about subjective economic stress included in the recent stress questionnaire (sq), developed and validated in italy (giorgi et al., ; mucci et al., ) . the economic stress measure is composed of two dimensions: (a) fear of the economic crisis (five items) -employees perceive that the organization is suffering from the economic crisis (e.g., "i am scared that my organization is affected by the economic crisis; i am scared that my organization, due to the economic crisis, will be subjected to downsizing"); (b) non-employability (five items) -employees perceive that their working competencies would not permit them to acquire another job in the market (caricati et al., ) [e.g., "my professionalism is not spendable (recognized) in the labor market; my staying in the organization is linked to the difficulty of outplacement in the labor market"]. each dimension includes five items in a five-point likert scale (from : "strongly disagree" to : "strongly agree"). we used a scale, included in the above mentioned stress questionnaire (giorgi et al., ; mucci et al., ) , that covers two factors in a five-point likert scale (from : "strongly disagree" to : "strongly agree"): this was measured with the general health questionnaire (ghq- ; goldberg and hillier, ; fraccaroli et al., ) . the scale asks whether the respondent has experienced a particular symptom or behavior related to general psychological health recently. each item is rated on a four-point likert-type scale ( - - - ). a higher score indicates a greater degree of psychological distress. in this study we particularly focus on the sub-dimension "anxiety and insomnia" (seven items, e.g., "considering the last few weeks, have you recently [. . .] felt constantly under strain?"). following anderson and gerbing's ( ) two-step structural equation modeling (sem) procedure, we tested a measurement model (cfa) by determining whether each measure's estimated loading on its expected underlying factor was significant. this allowed us to establish discriminant validity among the study constructs. then, a structural model was performed to estimate the fit to the data of the hypothesized model in which fear of expatriation mediates the relationship of mental health problems with economic stress and perceived dangerous working conditions (hypotheses and ) . a cfa was, therefore, performed with mplus, version . (muthén and muthén, - ) , with the four variables measuring mental health problems, fear of expatriation, economic stress, and perceived dangerous working conditions. moreover, the variables' dimensions were used as indicators of their corresponding latent constructs in the measurement and structural models. these dimensions were formed by averaging the items of each sub-scale for the four latent variables. we therefore obtained three indicators for mental health problems, two indicators for fear of expatriation, two indicators for economic stress, and two indicators for perceived dangerous working conditions. to evaluate the model fit, we considered chi-square (the higher the values are, the worse is the model's correspondence to the data), and used both absolute and incremental fit indexes. absolute fit indexes evaluate how well an a priori model reproduces the sample data. in our study, we focused on three absolute fit indexes: the standardized root mean square residual (srmr), for which values of less than . are favorable, and the root-mean-square error of approximation (rmsea), which should not exceed . (browne and cudeck, ; kline, ) . incremental fit indexes measure the proportionate amount of improvement in fit when a target model is compared with a more restricted, nested baseline model (schreiber et al., ) . we considered the comparative fit index (cfi), for which values of . or greater are recommended (schreiber et al., ) . as expected, the hypothesized four-factor model yielded a good fit to the data: χ ( ) = . , cfi = . , rmsea = . , srmr = . (table ) . additionally, as shown in table , this model had a significantly better fit than alternative, more parsimonious models (p < . ), supporting the distinctiveness of the study variables. table displays the descriptive statistics, correlations, and reliability coefficients of the variables. in order to examine the hypothesized model, we performed sem with mplus. sem offers the following advantages: (a) controlling for measurement errors when the relationships among variables are analyzed (hoyle and smith, ) ; (b) comparing the goodness-of-fit of the hypothesized model with other alternative models (cheung and lau, ). thus, we tested our proposed structural model and compared it with alternative models. additionally, when conducting sem analyses, we controlled for the effects of age and organizational tenure on both the mediator and the dependent variables. fit indexes for each tested model are presented in table . the hypothesized model (model ), which is a full mediation model, displayed a good fit to the data: χ ( ) = . , cfi = . ; rmsea = . ; srmr = . . specific inspection of direct relationships further revealed that mental health problems were positively associated with fear of expatriation (β = . , p < . ), thus supporting hypothesis . additionally, fear of expatriation, in turn, was positively related to economic stress (β = . , p < . ) and perceived dangerous working conditions (β = . , p < . ), thus providing preliminary support for hypothesis . completely standardized path coefficients for model are depicted in figure . to assess whether the hypothesized model was the best representation of the data, we then compared its fit to that of different alternative models. first, we assessed a partial mediation model, which included two additional direct paths from mental health problems to economic stress and perceived dangerous working conditions. this model yielded an adequate fit to the data (χ [ ] = . , cfi = . ; rmsea = . ; srmr = . ), but it was not significantly better than model , as revealed by the chi-square difference ( χ [ ] = . , ns). moreover, the additional direct relationships of workplace mental problems with economic stress (β = . , ns) and dangerous working conditions were not significant (β = . , ns). next, we compared the hypothesized model with a nonmediation model (model ), which only included direct paths from mental health problems and fear of expatriation to economic stress and perceived dangerous working conditions. results revealed that the non-mediation model was a slightly worse fit to the data than the hypothesized fully-mediated model however, because this model had the same degrees of freedom as the hypothesized model, the statistical significance of the chisquare difference could not be calculated. accordingly, we used the akaike information criterion (aic), instead of the chisquare, to compare the two models. the hypothesized model is considered to be superior to the non-mediation model if the former has an aic value lower than the latter by four or more units (burnham and anderson, ) . results revealed that model had an aic of . compared to an aic of . for model , suggesting that the hypothesized full mediation model represents a superior fit to the data than the non-mediation model ( aic = . ). furthermore, because mental health problems, fear of expatriation, economic stress, and perceived dangerous working conditions were all measured at the same time, reverse relationships could also be expected between the four variables. in order to rule out this possibility, we therefore compared the hypothesized model against a set of alternative models that specified all the possible reverse indirect relationships among the study variables, namely: the indirect relationship of economic stress and perceived dangerous working conditions with fear of expatriation via mental health problems (model ); the indirect relationship of economic stress and perceived dangerous working conditions with mental health problems n = . cfi, comparative fit index; rmsea, root-mean-square error of approximation; srmr, standardized root mean square residual; akaike information criterion χ = chi-square difference tests between the best-fitting model (model ) and alternative models; aic, akaike difference test between the best-fitting model (model ) and alternative models. fex, fear of expatriation; fec, fear of economic crisis; dwc, dangerous working conditions; mhp, mental health problems. * p < . . via fear of expatriation (model ); the indirect relationship between mental health problems and fear of expatriation via economic stress and perceived dangerous working conditions (model ); the indirect relationship of fear of expatriation with economic stress and perceived dangerous working conditions via mental health problems (model ); the relationship between fear of expatriation and mental health problems via economic stress and perceived dangerous working conditions (model ). again, because models - had the same degrees of freedom as the hypothesized model, we compared the model fit by using the aic difference test. as can be seen from table , models - all yielded a worse fit to the data than the hypothesized model. overall, results from model comparison suggested that model was the best fitting model. we therefore retained the hypothesized fully-mediated model. finally, in order to assess whether the indirect relationship of mental health problems with economic stress and perceived dangerous working conditions through fear of expatriation was significant (hypothesis ), we calculated % bootstrapping confidence intervals (preacher and hayes, ; preacher and kelley, ) . based on , bootstrap replications, results indicated that mental health problems had an indirect positive effect on economic stress (indirect effect = . ; % ci = . , . ) and perceived dangerous working conditions (indirect effect = . ; % ci = . , . ) via fear of expatriation. hypothesis was therefore fully supported. in a globalized working environment with turbulence in the economy and in the security expatriate workers are confronted with several stressors, making international assignments potentially stressful. accordingly, expatriate managers might report lower psychological well-being and anxiety (wang and kanungo, ; shaffer et al., ; wang and nayir, ) . at the same time, fears are now increasing in the workplace, marked by emotional discomfort, apprehension, or concerns about the internal and external environment, and expatriates seem particularly at risk. these symptoms can progress to more severe psychosomatic symptoms, including further anxiety and additional fears (blum et al., ; besnard and sahay, ) . in our model, fear of expatriation is particularly associated with mental health problems. this result is in line with the field literature (i.e., perone et al., ; andresen et al., ; aracı, ) . in addition, an expatriate might go through several personal and professional problems. in fact, expatriation is associated with a lot of unhealthy issues such as stress, anxiety, loneliness and homesickness, generating a sort of potential and prolonged cultural shock (barón et al., ) . finally, it must be emphasized that expatriates cannot count on the support of family and/or other trusted people if they need it (bhaskar-shrinivas et al., ) . fear of expatriation might generate a spiraling effect in which people, feeling more anxious, might become less engaged in the workplace, developing beliefs that money and extrinsic reward are the most important aspects of employment (gerhart and fang, ) . at the same time, they may be more worried about their financial situation and their ability to hold on to their jobs and their benefits, developing their fear of economic crisis. on one hand, from a subjective point of view, h&s measuresunder certain circumstances (for instance, the emergence of fear in the workplace) -do not necessarily express feelings of safety, but rather can be interpreted as latent danger (bader and berg, ) generating a widespread anxiety. on the other hand, from an objective point of view, expatriates are often exported to societies with weaker and less expensive h&s policies and less organized labor forces, bringing potentially stressful and unsafe working conditions (heymann, ) to expatriates. this might raise a perception of dangerous working conditions. moreover, h&s procedures are usually highly specific to each country and with very important differences -related to the various national legislations and traditions -and working conditions abroad are generally perceived as less familiar and presenting higher risk (taylor et al., ) . expatriates are a group of people with a high cumulative risk of exposure to illness and injury (including the increased risk of certain vaccine-preventable illnesses) due to changes in travel patterns and activities, lifestyle alterations, and increased interaction with local populations. pre-travel immunization management provides one safe and reliable method of preventing infectious illness in this group; however, this might not be enough to cope with anxiety (vaid et al., ; shepherd and shoff, ) . in addition, there are diseases that are not preventable with vaccines. these diseases, in particular of a viral nature, seem to spread faster nowadays -such as, for example, the recent ebola or middle east respiratory syndrome (mers) outbreaks -and might be frightening for expatriates (cohen et al., ; regan et al., ) . in summary, the non-optimal h&s perception (beeley et al., ) , the risk of contracting infectious diseases (jones, ; hamlyn et al., ) and the unsuitability of medical care (pierre et al., ) were also evaluated under the construct of the fear of expatriation. in our study, expatriates reported being frightened by the risk of becoming involved in accidents during their frequent moves from one country to another. in particular, this fear seemed to be greater for traffic accidents (wilks et al., ) , but a fear of flying was also described (hack-polay, ) . a further and significant stress factor for expatriate workers is the managers' fear of terrorist attacks or other fatal events involving the governments of countries where there are companies' headquarters (leistedt, ; bader and schuster, ) . finally, in our model we consider the concerns about the working and living conditions (costa et al., ; zhu et al., ) . in addition, our model has shown that the presence of fear of expatriation may, in turn, generate further fears in the workplace. in particular, fears of both the economic crisis and of the foreign working conditions are mediated by fear of expatriation. in fact, fear could adversely disturb human thinking and decision-making processes, leaving the individual more susceptible to generating further fears, as in a vicious circle (barón et al., ; besnard and sahay, ) . our findings are in line with the basic propositions of lazarus and the "affective events theory" (aet; weiss and cropanzano, ) . the latter pointed out that an emotion experienced by a worker (e.g., fear) may impact on later within-person emotions (e.g., fear again), influencing different organizational outcomes. as far as economic crisis is concerned, economic stress might be more frightening for those who have more invested in the company, such as expatriates. in fact, these workers, being away from home for extended periods of time, are completely absorbed by their job and, therefore, they may be an easier target for contagious negative emotional cycles (quantin et al., ) . moreover, they could be most affected by the psychological impacts of the economic crisis and its consequences as they have lower levels of social support (fernandez et al., ) . similarly, fear of expatriation may significantly lead to perceiving a priori all foreign working conditions as being more dangerous. these findings support our assumption and the literature (perone et al., ; andresen et al., ) . the impact of working and living conditions -resulting, for instance, in perceived risks of harms -might be higher if expatriates are scared by the impeded living conditions or by the threat of violence. this might have several negative implications as often expatriates have the tendency to "get the job done" as smoothly as possible, so they can return home again (aracı, ) . however, this specific issue should be investigated in future studies. our findings provide interesting contributions both to the literature and to the managerial practices in the field of foreign work. first, we believe that the subjects in the process of leaving their own country should be mentally healthy and not feeling frightened by either the place of destination or the assigned tasks. according to lazarus and folkman ( ) , if an expatriate is worried and anxious, it is less likely that he/she will ever adjust. therefore, it is essential to help expatriates to prevent the development of any type of fear. strategies of prevention and rationalization, particularly useful in this sense, can be implemented through several instruments: specific training for foreign services, company's reference facilities in countries where employees come to work, remote counseling (on-line/phone) provided by occupational physicians and psychologists affiliated with the company, company procedures for immediate repatriation in the case of adverse events (e.g., terrorism, infective outbreaks, and health problems), etc. in the second place, stress management training is also recommended. from this perspective, issue-focused coping strategies seem crucial to counteract fearful feelings as well as to minimize the states of anxiety and distress (folkman et al., ) . thirdly, companies should conduct preventive screening to identify the human resources to be sent to foreign countries, favoring those who have demonstrated both a highly qualified professionalism in their field and robust mental health (stone, ; di fabio, , . consequently, a process for the successful management of expatriation needs to be adopted using both individual and organizational strategies to reduce the possibilities of stress among expatriates. at the organizational level, selection, training, healthcare activities, and counseling need to be implemented and monitored in order to prevent the diffusions of workplace fears. at the individual level, expatriates should be psychologically supported, e.g., with mentoring and coaching, analyzing competencies, health perceptions, and mood over time (de paul and bikos, ) . our study has many and innovative strengths but is not without limitations. although the expatriates worked worldwide, the sample was limited to a single company, limiting the generalizability of the results. in addition, the sample was composed only of men. however, by virtue of family demands, men expatriate much more frequently than women. our scale fear of the expatriation is new in the literature and, consequently, a replication of this study is needed. in addition, we look forward to more large studies whose starting points are the results of the first application of our scale. in particular, comparative research evaluating stress responses between italian and other ethnic populations around the world would be particularly helpful. this study used a cross-sectional design, resulting in the impossibility of determining causal relationships. longitudinal research is needed in order to provide further evidence that mental health problems cause fear of expatriation, which, in turn, may generate additional workplace fears. in summary, following this new research path, we have developed a new model, formulated a new theory that found an association between mental health and fears in the workplace, and explored different fears in the workplace and their links. our results confirmed our innovative hypothesis and we suggest that companies' key people take into account the construct of fear of expatriation for business health purposes. with this in mind, companies need proper advice from qualified consultants such as occupational physicians and industrial psychologists. an investment dedicated to the prevention and protection of the h&s of expatriate workers is not only an instrument of risk assessment -in the context of the obligations under the laws of eu countries in the field (e.g., the italian legislative decree n. and subsequent amendments) -but also, and moreover, a significant tool to improve the company's business. some studies have estimated that the cost associated with the failure of expatriation would be about one million usd (insch and daniels, ; wentland, ) . overall, considering the aggregate data about the american situation, punnett ( ) has calculated that us companies spend a total of up to two billion usd annually to address the failures of their expatriate managers. in such a context, it is legitimate to expect that 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is an open-access article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- - ryhc authors: gostin, lawrence o; daniely, tamira; huffstetler, hanna e; williams, caitlin r; meier, benjamin mason title: the shibboleth of human rights in public health date: - - journal: lancet public health doi: . /s - ( ) - sha: doc_id: cord_uid: ryhc nan human rights discourse has greatly influenced advocacy for justice in public health. yet, beyond rhetorical claims, how can we employ human rights to achieve the aspiration of health with justice? without human rights education to support public health practice, human rights have become a shibboleth of public health-raised frequently to signal devotion to justice, but employed rarely in policy, programming, or practice. as advocates respond to the public health injustices of populist nationalism during an unprecedented pandemic, human rights education must be an essential foundation to hold governments accountable for implementing rights to safeguard public health. human rights are based on the powerful idea of equal dignity for all people. by establishing international standards for health justice, human rights have been transformed from the rhetorical to the actionable, as legal obligations have been developed to realise the highest attainable standard of health. governments have established these universal rights under international law through the un, beginning in the universal declaration of human rights and elaborated through an evolving range of health-related rights. by structuring government responsibility for the promotion of health, international human rights law can translate calls for justice into public health action. human rights law thus defines what governments must, or must not, do to ensure the equitable enjoyment of health for all. international human rights law obligates governments to realise specific rights through health policies, programmes, and practices. this national implementation of international law seeks to translate human rights law into public health realities, structuring fairness in health policy making and affording equal rights to health goods and services. human rights empower civil society movements for health justice by proclaiming a global standard for physical, mental, and social wellbeing. through this global standard, human rights require government action to respect human freedoms, protect individuals from harm, and fulfill basic needs. seeking to ensure government action, a range of policy mechanisms exist to facilitate accountability for national implementation. by providing an external check on government efforts, these accountability mechanisms require government officials to show how they have either realised, or taken progressive steps to realise, their human rights obligations. this process not only identifies which aspects of health policy are insufficient or harmful, but also provides opportunities for redress of health grievances, with human rights advocacy holding governments to account for implementing international human rights law. the current era-beset by a devastating pandemic and resurgent nationalism-has presented new challenges in facilitating government accountability to respect, protect, and fulfill human rights to advance public health. in response to the covid- pandemic, some governments have violated human rights and undermined global governance, retrenching inward when global solidarity is needed most. it is necessary for the next generation of leaders to reinvigorate the commitment to universal rights in public health, implement human rights through public health practice, and lead rights-based advocacy to ensure that governments are held accountable. in preparing this next generation of leaders, human rights education provides a necessary foundation for public health engagement. the academic discipline of health and human rights amplifies demands for justice in public health, reimagining claims for health-related rights through health policy reforms. schools of public health have increasingly developed courses on human rights, combining rigorous understanding of international legal standards with public health science. public health programmes have long embraced a focus on justice, but recent curricular reforms seek to strengthen student understanding of human rights under international law, examining how the realisation of rights shapes the lived reality of health. these legal foundations provide an actionable basis for public health students to become human rights advocates, mainstreaming human rights norms and principles in public health policies, programmes, and practices. as public health responds to rising challenges of health injustice, in the pandemic response and beyond, strengthening human rights training for the next generation is imperative. through shared competencies for human rights education in public health, faculty can global health law: legal foundations for social justice in public health years of human rights in global health: drawing on a contentious past to secure a hopeful future translating international law into domestic law, policy, and practice monitoring and review to assess human rights implementation foundations of global health and human rights the right to health must guide responses to covid- global health and human rights in the age of populism human rights in public health: deepening engagement at a critical time key: cord- -dg jg t authors: el achi, nassim; honein-abouhaidar, gladys; rizk, anthony; kobeissi, elsa; papamichail, andreas; meagher, kristen; ekzayez, abdulkarim; abu-sittah, ghassan s.; patel, preeti title: assessing the capacity for conflict and health research in lebanon: a qualitative study date: - - journal: confl health doi: . /s - - -x sha: doc_id: cord_uid: dg jg t background: conflicts pose new challenges for health systems, requiring rapid and practical approaches to meet emerging needs on the ground. lebanon has been highly influenced by surrounding conflicts in the middle east and north africa (mena) region, especially the syrian crisis. strengthening research capacity to collect evidence on conflict in the mena region and beyond is crucial to inform healthcare policy and practice. for targeted capacity strengthening interventions, the main objective of this paper is to present key findings of a needs assessment of conflict and health research in lebanon. this will support recent efforts to scale up context-specific policies, interventions to strengthen the country’s health system, and research capacity. methods: the study is based on semi-structured interviews with key informants such as specialist academics, humanitarian workers and public sector officials. results: despite being ranked third in the number of publications on biomedical and health research per capita in mena and in hosting reputable universities which are considered central academic hubs in the region, lack of nationwide research culture, insufficient funding and limited access to data were reported to be major challenges for health researchers in lebanon. even with the ongoing efforts, poor impact of research on policy continues to be a persistent gap. large disparities in research capacities and taught skills were reported between different universities in lebanon, with a disproportionate emphasis on quantitative over qualitative skills. most medical students are not trained to conduct research or to practice in conflict settings. concerns were also expressed regarding the ethics of research conducted, specifically by local non-governmental organizations. recommendations: to conduct contextualized trainings on research skills with a stronger focus on qualitative approaches, medical practice, and ethical research in conflict. to better involve policymakers in designing research agendas by organizing multiple stakeholder meetings. conclusion: the study indicates that health research in lebanon is characterized by considerable strengths in terms of human capital and research capacities of certain universities. however, the lebanese research infrastructure needs further development in terms of ensuring sustainable funding, providing access to data, teaching qualitative research skills, conducting ethical and multidisciplinary research, and promoting cross-sectoral knowledge transfer. research capacity strengthening has been a top priority for the world health organisation (who) since , paving the way for substantive investments from research funding agencies and international institutions [ ] . while evidence generated from health research is crucial for addressing health and development challenges in countries and regions affected by armed conflict [ ] , the capacity to conduct locally relevant health research faces specific challenges in contexts affected by acute and protracted conflict. in conflict settings, health research is often deprioritized as focus shifts to improving security, conflict resolution, short-term humanitarian responses and managing forced migration [ ] . however, the protracted nature of contemporary conflicts and their long-term impact on health provision has led to an increased demand and willingness to conduct and strengthen health research capacity in conflict-affected settings [ ] [ ] [ ] , including countries in the middle east and north africa (mena) region [ ] . the mena region is no stranger to conflicts, many of which are complex and protracted (see table for definitions). the first wave of the arab spring in included large-scale mobilizations and political upheavals across the region, with armed conflicts developing in libya, yemen, and syria and mass displacement leading to the worst humanitarian crisis since world war ii [ ] . in , % of . million people displaced worldwide originated from the mena region [ ] . this process continues as more recently in , the second wave of the arab spring emerged in algeria, sudan, iraq and lebanon, with anti-government protests table key definitions lmic (low and middle-income country): according to the world bank's definitions, drawing on figures, low-income economies have a gross national income (gni) per capita of $ or less; the gni per capita of lower middle-income is between $ and $ ; and upper middle-income economies like lebanon have a gni per capita of between $ and $ , [ ] . capacity strengthening: as a working definition, capacity strengthening can be understood as a process of developing, upgrading and/or expanding pre-existing capabilities at individual, organisational, and institutional levels to plan, conduct, and disseminate evidencebased knowledge [ ] . the individual level includes researchers and research teams; the organisational level is composed of university research departments, think tanks and similar organisations; and the institutional level encompasses the regulatory environment and includes governmental bodies and policymakers [ ] . installing transitional governments amid calls for major reforms [ ] . these protests have significantly changed in intensity, spread and frequency since onwards but got fully subsided due to government measures to control the spread of the covid- pandemic in february-may . although it is premature to predict the post lockdown trajectory across the mena region, it is speculated that protests will regain momentum, exacerbated by severe economic and fiscal crises compounded further by the viral outbreak, as it is the case in lebanon where violent protests erupted in late april in response to severe economic hardship [ , ] . such an endemic fragility results in a serious rise in health burdens and inequalities that place serious pressure on the region's health systems which are already coping with the protracted nature of conflicts [ ] . the mena region thus needs continuous strengthening of its health research, at the institutional, organizational and individual levels to address these highly volatile health and social needs (see table for definition) [ ] . in recent years, the mena region has been one of many sites of increased investment and interventions in health research capacity strengthening. programmes such as the eu-funded research capacity for public health in the mediterranean (rescap-med) [ ] , the uk-funded research capacity building and knowledge generation (recap) [ ] and research for health in conflict middle east and north africa (r hc-mena) [ ] projects are examples of recent and ongoing mena-focused health research capacity strengthening interventions. r hc-mena, focused entirely on strengthening research capacity in the conflict-affected mena region by implementing contextually relevant activities, is an interdisciplinary partnership led by king's college london with uk partners such as imperial college london and the university of cambridge, mena-based partners that include the american university of beirut (lebanon), birzeit university (palestine), hacettepe university (turkey) and king hussein cancer centre (jordan), and several humanitarian and policy organisations. such activities include developing and delivering accredited multi-disciplinary courses, mentoring senior leadership at national and global/multilateral institution levels, and developing innovative learning technologies and informatics platforms for distance learning [ ] . lebanon, which is the focus of this paper, is an upper middle income country in the middle east with the highest refugee density worldwide following the syrian crisis [ , ] . it has been politically and socioeconomically influenced by regional conflict and crisis, as well as its own civil war ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ), israel's second lebanon war ( ) and protracted internal strife (see table for definition). although there has been a long-standing engagement with conflict and health research in lebanon [ ] , research outputs in the country were negatively affected by instabilities in war times [ ] , but managed to quickly recover following the end of the civil war [ ] . however, recent regional mobility of conflict-injured patients and the high influx of refugees have stimulated a renewed focus on conflict-related health research [ , ] . note that lebanon has a long history of academic research compared to other mena countries and has one of the highest numbers of publications and researchers per capita in mena. it also has strong medical and health research provided mainly by university hospitals such as the american university of beirut medical center and hotel dieu de france, both respectively affiliated to the large private and prestigious universities-the american university of beirut (aub) and université st-joseph (usj). lately other universities, including the lebanese university, balamand university and beirut arab university, are also focusing more on enhancing research capacity and outputs. however, most of lebanon's research production comes from the aub which has made considerable efforts to promote research production and translation [ , ] . an analysis of the country's capacity for conflictrelated health research is currently lacking, even as evidence for designing contextualized capacity interventions becomes more urgent. building on a conceptual framework on capacity strengthening of health research in conflict-affected countries that focussed on the mena region [ ] (fig. ), we conducted a needs assessment in lebanon to answer three main interrelated questions: what is the current capacity for conflict and health research in lebanon? what are the challenges and gaps in conflict and health research in the country? and, lastly, what are the preferred tools and mechanisms of strengthening the country's conflict and health research capacity from the perspectives of academics, humanitarian actors and public sector officials? the main aim of this paper is thus to analyse the strengths, weaknesses, opportunities and threats to conflict and health research capacity strengthening in lebanon. we employed a qualitative approach using semistructured interviews with academics, humanitarian workers and public sector officials as the main method of data collection. due to scarcity of data sources on health research capacity in lebanon, we opted for a qualitative approach that would additionally contribute to developing and refining interventions [ , ] . in a previous related study, our research group designed a working conceptual framework on capacity strengthening of health research in conflict-affected settings, which was the basis for the topic guide for the semistructured interviews [ ] . we used purposive sampling followed by snowballing sampling to identify interviewees. to achieve maximum variation, we sought out research participants from diverse geographic areas, ages, genders, and specialties ( table ) . key informants consisted of three professional categories: ) academics from various universities across lebanon, ) humanitarian workers working with local or international non-governmental organizations (ngos) or united nations (un) agencies with operations in the health sector, and ) public sector officials working at ministry of public health (moph) and the ministry of social affairs (mosa). all research participants worked professionally in fields related to health, conflict and research in lebanon. we included academics working at universities that provide postgraduate degrees as these tend to be more inclined towards research than universities that only provide undergraduate programmes. out of the informants approached, refused to participate or did not reply to the invitation email and subsequent conceptual framework for health research capacity strengthening in conflict [ ] reminders, leaving a total sample size of research participants. we continued recruiting key informants until we reached thematic saturation. we conducted face-to-face interviews between february and may across lebanon. semi-structured interviews were conducted in locations specified by the interviewees and were recorded when permitted to do so by the participant (n = , %), otherwise taking detailed notes of the interview (n = , %). the interviews were conducted in either english (n = , %) or lebanese arabic (n = , %). most participants (n = , %) agreed to be quoted in anonymized form. using a topic guide (additional file ), questions addressed experts' perception of research in conflict settings, strengths and challenges in conducting research in lebanon, and recommendations to strengthen conflict and health research capacities in lebanon. to ensure clarity and relevance of questions, we consulted key experts from each professional category for the development of the topic guide. the interviews lasted approximately min. interviews were first transcribed into english and arabic and transcripts in arabic were then translated to english. all transcripts were anonymized using a unique identifier for each participant. the assigned code, used for citation purposes below, was composed of a letter that refers to the professional category of the participant [academic (a), humanitarian worker (ngo) and public sector official (m)] followed by a number that represents the chronological order of the interview. for example, a codes for the th academic and m for the second public sector official that we interviewed. we used nvivo ® for data management and thematic analysis. we adopted the phase process described by braun and clarke [ ] . first, two investigators (ne, ek) worked independently on coding two transcripts line by line. together, they discussed their coding approach to identify similarities and differences, thus avoiding interpretability bias, and created a thematic framework for data analysis. second, the same investigators completed the open coding and started identifying emerging categories. members of the research team (gha, ne and ek) met on several occasions to reflect on the findings and identify the candidate themes and sub-themes. the latter to further increase rigor, we focused on achieving both credibility and reflexivity. regarding credibility, all discussions, except , were audio recorded, transcribed verbatim, accurately translated into english as necessary, and utilized as the main data repository. once reaching data saturation, a decision was made by all team members to cease data collection. as for reflexivity, and to limit biases, all team members were involved in the analysis and interpretation of the results. the participants in this study were academics, humanitarian actors, and public sector officials ( table ) . they are based in four different regions of lebanon -beirut, mount lebanon, north lebanon and bekaaall of which are central areas where major ngos, education and research institutes with a focus on health research are located. the academics interviewed in this study collectively work at out of a total of accredited universities in lebanon that provide health research training at the postgraduate level [ ] . the main themes that emerged are in accordance with those specified by the conceptual framework previously designed by our research team: perception of research capacity strengthening, research culture, current capacities and strategies of universities, research skills, infrastructure (data availability & ethics), funding & sustainability, partnerships (local & international) and the role of women working in lebanon in health research [ ] . when asked about defining research capacity strengthening, the responses varied significantly ranging between considering it as a "training" mostly by local informants to a more detailed understanding targeted towards the individual, organizational and institutional levels. these variations were highly related to experience in previous capacity building interventions. nonetheless, the term "capacity building" was used regardless of the context. for instance, locals used this term more often than those working with international ngos who preferred to use the term capacity strengthening since "building means starting from scratch which is rarely the case" (ngo ). many informants pointed to a 'lack of research culture' as a major challenge for conducting health research in lebanon: "i don't think we are in lebanon so strong in terms of research, conducting research; we don't think about research as a major power" (a ) "we [lebanese] spend a lot of money on it [education] . but then when it comes to moving forward, making innovations, i don't think we are the culture that nurture this environment of research" (a ) few informants also described hierarchical and challenging working conditions that can be counter-productive. "i might be very negative but i see a lot of motivated young researchers whose work is repressed by people at powerful positions … this is a major barrier to the progress of research" (a ) however, at the individual level, all of the informants expressed willingness to strengthen their health research capacities by making the best of the available resources. career progression via promotion and improving job prospects were considered the main drivers for enrolling into trainings, courses, internships and volunteering opportunities; along with personal motivation. "i am not strong enough in qualitative research so when i knew about the course, i directly got involved despite that the university didn't cover the expenses. i like to improve my skills. it is something i have deep inside."(a ) it was clear from the interviews conducted that there were huge disparities between the universities in lebanon in terms of budget, qualifications, human resources and infrastructure. all of those interviewed agreed on the importance of research and considered it to be a major pillar of the universities' strategies. some universities, especially the highly ranked ones, allocate some of their budgets to fund research to complement external grant income. changes at the organizational level and pushing academics to conduct more research are favoured to obtain accreditation from the ministry of higher education, or to adhere with international standards of research and to gain a better reputation to attract students particularly for the private universities. "the university puts a lot of money in research, with a certain amount of the budget allocated specifically for this purpose" (a ) to incentivize academics to conduct research, most of the universities are considering publishing and research as major requirements for promotion and/or qualification for tenured positions. "so there's a promotion system. if you want to get promoted, you have to publish […] so there's a percentage. it's % research, % service and % teaching." (a ) one of the informants highlighted that one of the leading universities is also adopting a strategy of forming research institutes and centres within the university, which focus only on providing executive trainings, courses, and knowledge to policy schemes along with knowledge production and research that could enhance the learning experience at the university. "along with education, we have multiple interfaculty research centers and institutes which deal with emerging health issues at the national and global levels." (a ) however, there were complaints from academics in smaller universities about not having time to conduct research as they are overwhelmed with other duties so that they try to conduct research in their extra time. "if the department asks me to teach courses every semester, i don't think that i have much time left for research.." (a ) according to most of the informants, individual research capacity for postgraduates is relatively high in some areas (epidemiology, health interventions, biostatistics) focusing on quantitative skills, especially in the top five universities in lebanon. the research skills of undergraduates are considered by most of the respondents to be mostly introductory and insufficient for conducting rigorous research. nonetheless, all universities do provide courses on research and writing skills, but this tends to be at the postgraduate rather than the undergraduate level. altering the content of courses would be challenging, as it would require new accreditation from the ministry of higher education along with the internal institutional bureaucracy which is very time consuming. as a result, some informants admitted that they prefer to give extracurricular workshops to cover key gaps in research skills at the undergraduate level. "they don't have this course (research design), i think they take a statistics course and introductory research course but they don't know what it means on the undergrad level… you cannot rely on undergrads to collect data if data needs interaction with participants… you need to get someone at the graduate level" (a ) "so if we have a gap in our curriculum related to research or even to the theoretical courses we bring expert and we do workshops and conferences… we are trying to fill the gaps with some extracurricular activities" (a ) the gaps identified by most of the informants are in the social sciences, history, and political economy and mainly in qualitative research designs despite stating that mixed methods are important for a more holistic understanding of the health impacts of conflicts. "the other thing even on the postgraduate level, qualitative research is hardly taught. this is another main issue … we do quantitative blindly and the qualitative, which i think is much more significant for us … is not … i waited for my phd to take a qualitative course. and still, i took a summer qualitative course when i was already a faculty to go over the themes..." (a ) "…at times qualitative studies, which bring about a treasure of information that statistics do not often give …" (a ) when asking informants working in the humanitarian field, they emphasized that graduates from lebanese universities have excellent quantitative research skills (depending on the university attended). however, they mentioned that there is a high demand in qualitative methods and tools of analysis to understand impact evaluations which fresh graduates lack. "we do a lot of interventions in the field, but we never understood the impact of the intervention and we don't know if the impact achieved was the result of what we did or result of other factors… so i think in order for us to replicate some interventions and to understand the weaknesses or the failure of some interventions, it's very important to understand the impact. we need qualitative research" (ngo ) interviews also indicated that monitoring of research quality and ethical approval in lebanon are usually to meet the standards of international funders rather than local governments. thus, ethics was a major theme highlighted by all informants. most of the academics interviewed had institutional review boards (irb) at their institutions for granting approvals before conducting any research involving human subjects. the only downside of the irb was the delay and difficulty in obtaining approvals especially when working with vulnerable populations. however, an informant mentioned that having an irb is not enough to ensure ethical research. "all kinds of research with the proviso that the culture, context and participants full rights are respected… and that they 'benefit' from the research one way or the other" (a ) an informant also mentioned the wellbeing of researchers, which is mostly ignored, as a key ethical determinant that should also be considered along with that of participants. "at times qualitative studies can be a traumatizing experiences. thus, it is important to have good solid ethical review for the research and psychological support to both researchers and participants when needed." (a ) as for ngos, there is a huge difference between international and local humanitarian actors. for the former, there are strict rules when it comes to dealing with vulnerable populations, whereas for the latter, this concept might be lacking. due to the limited regulation of research in the field, there are serious concerns about researching vulnerable populations, with infringement of the international regulations of ethical research especially in conflict settings. "our main mandate is protection and protection of cases. confidentiality is for example one of the tolerance for [organization name]. we also have ethics guidelines where everyone, every student needs to read, sign and abide. it's very strict, it's tolerance." (ngo ) the absence of oversight on research ethics in lebanon was a recurrent concern. for some, governmental oversight on research ethics would be detrimental, for fear of it being restrictive, especially when 'sensitive' topics are researched. for others, the repetitiveness of the same research projects on the same populations (for example, syrian refugees) is detrimental, often being intrusive, dehumanizing, or inappropriate (an example given is asking people who are hungry to document their meals). as indicated by a public servant, "usually ngos working in the field are not affiliated to any irbs in hospitals or universities. […] . i'm sure there's a lot of research at the being conducting on syrian refugees. and unfortunately ngos working in the field are not aware of these requirements of having ethical approvals, of the informed consent process, and all of these. the research that i come countered with by accident because we have no mechanism to find out what's going on. the way we catch them is when they take biological samples and they want to export it outside the country and they need the approval of moph. there is a study that we ended up putting under control … it was done between lebanon and a university outside .. it was a dna testing. they considered it not a big deal since they collect saliva and cells with toothpicks. i forced them to get ethical approval and to understand what they're doing with the samples beside research." (m ) as indicated by m "we (local centres of mosa) don't conduct research but provide data for institutes following the permission from mosa", health research data if available can be provided by moph and mosa. private hospitals also have their own databases that can be used in research. however, as indicated by most academics, access to data is a huge challenge that limits the ability to conduct impactful research. "there is no databases so you know if you want to have information about the patient, about any health problem, it's really hard to get what you need to know about it." (a ) "so when you go to private hospitals, they have a different interests. if there is a conflict with business because they don't want to have their image tarnished because of certain quality indicators which are not optimal or because that will reduce the number of patients coming to their services, they're very resistant to conduct research. and if they do conduct research, they show only the positive side of it." (a ) interviews with humanitarian agencies indicated that data collected is for basic analyses to inform the programmatic direction of the agencies, and not necessarily for statistically advanced quantitative or in-depth qualitative studies and thus can be of minimal use to academic research. moreover, one informant highlighted the problems that arises from interpretation of available data especially in conflict-affected settings; "data though can be misleading depending on how it is interpreted and by whom." (a ) all academics interviewed thought that partnerships and collaborations at both the national and international levels were crucial and highly beneficial for the progress of work. they suggested that these partnerships could help to mitigate the gaps and barriers of health research in the country in terms of infrastructure such as expensive equipment. for instance, international partners provide an opportunity for the local academic institutes to get access to facilities and equipment which are unavailable in lebanon and/or are too expensive to purchase and maintain. similarly, several local universities have joint phd programs with international universities for local students to produce high quality research which is context-oriented while still getting access to facilities available in international academic institutions. informants also mentioned examples of exchange of faculty members between universities as a way of knowledge and strengthening experience for both faculty and students in both institutes. partnerships were also considered as an opportunity to bring grants to the local institutes to conduct health research as it is more appealing for international funders to fund consortia rather than a single university or institute in lebanon. informants mentioned projects funded by the european union, uk research councils, and national council for scientific research (cnrs) included partnering with other local and international universities. partnerships between academics and local ngos were considered to be important as they provide access to refugee camps and local communities and help with logistical arrangements and security of data collectors. "as an academic institution […] you need to collaborate with an ngo for them to provide access to camps […] it's also always better to have someone from the ngo to stay with you for security measures or if anything is to happen on the field as researcher" (a ) the moph and mosa informants also highlighted the importance of collaborating with un agencies such as who, united nations educational, scientific and cultural organization (unesco), united nations development programme (undp), united nations international children's emergency fund (unicef), united nations high commissioner for refugees (unhcr) … and other international ngos that sponsor and deliver capacity strengthening workshops, trainings and seminars for the public sector officials working in these ministries. "usually when there is a training that the ministry wants to conduct, we approach these organizations for two things: first for providing technical experts to conduct the trainings, because it provides a better credibility for the training, and second for logistic support… but these trainings are not for research skills" (m ) some of the topics that were mentioned by the informants include: "psychological support, service provision, finances, management, training of trainers (tot), communication for development (c d)… following the syrian crisis, more trainings were conducted on topics related to child protection and gender-based violence… the content of these trainings is regularly updated." (m ) despite highlighting the importance of partnerships with local and international actors, it was found that most of these partnerships were within the same category: academics-academics, or ministry with ngos. the lack of coordination between ngos for example, out of competition or lack of communication in a highly unregulated field was reported to be a major drawback. "i feel there is no universal coordination at least per country and the national level, to divide efforts in a way that's equitable on all levels so there could be too many interventions happening on one topic, let's say reproductive sexual health, just an example. and too little happening on mental health. so if efforts were combined and property divided, i feel it would be more beneficial." (a ) even within academia, an informant mentioned that the current 'academic silos' coupled with the "fragmentation of academic disciplines" and 'over-specialization' of research areas is a major limitation for interdisciplinary research in lebanon. on the other side, most of the informants considered that policymaking is not evidence-based, relying on what are called 'cold' experts (the opinions of ministers, public personalities, funders, etc.) rather than empirical research. however, an informant from moph blamed this lack of coordination on the academic institutes that "live in their own bubble" and disseminate their findings in publications that policy makers have no time to read. the informant highlighted the importance of involving policymakers in a research from the early stages to improve the collaboration. "for example will we (moph) know about the academic research when it is done? its recommendations? there is no link... they present their findings in conferences and then say policymakers are not responsive .. how would we know about the research, we don't have time… policymakers should feel that they are setting research agenda and are more involved in the research process" (m ) for many, the main challenge is not the lack of individual research capacities, especially when it comes to quantitative research skills, but more the infrastructural capacities (database) and the availability of research funding. funding and sustainability have been identified as two of the main interlinked challenges for capacity strengthening for conflict and health research. informants argued that sustainable capacity strengthening is largely determined by the sustainability of funding. for laboratory sciences specifically, building of individual capacity in microbiology, for example, is limited when basic research infrastructure and sustainable funding for technologically and labour-intensive laboratory-based research is lacking. at the core of this in lebanon is the near absence of local funding, and the high dependency on highly competitive international grants and schemes. researchers describe competing for rigid international grants and research funding, while working in highly unstable research settings, require a high level of flexibility and adaptability. most institutions struggle to pay competitive salaries for pharmacists or medical doctors to conduct and generate evidence-based research. most of the informants indicated that adapting research questions and methods to secure funding was fairly common. such a high level of instability is also a disincentive for long-term planning. "naturally that's what happen most of the time… we have to go work with whatever the market is." (a ) however, few informants mentioned that funding is not an issue if a well-designed project is prepared especially for internal funding provided by universities or by local industries. "if we prepare a decent research protocol. i think that we can get funds.. even the scientific associations, if there is a good protocol... money is not an issue" (a ) "my motto is if you have the will you have a way…i think the other factors become secondary…. so funding could be a factor, but again it's not the major barrier or challenge." (a ) as for the humanitarian sector, according to informants, funding for humanitarian relief and operational research has slowly decreased, potentially leading to increased competition among local ngos that would limit even more the coordination among these humanitarian actors. as for international ngos, fewer resources are allocated to them in lebanon and thus they are currently withdrawing slowly. when asked about women's involvement in health research in lebanon, most of the informants, regardless of their gender, indicated that discrimination is not a major issue as women are capable of reaching high positions in academia. "representation of women at our institute is fantastic, more than %; % of researchers and teachers are women, out of deans are women and out of are vice presidents" (a ) most of the respondents were reluctant to consider lebanon as a conflict setting as it is not struggling with ongoing armed clashes. but they considered lebanon as a conflict-affected setting due to the huge influx of syrian refugees. at the research and development level, most of the informants agreed that being a conflictaffected country has led to an increase in research funding and opportunities. however, most of the research funded was focusing primarily on refugees. "i guess what happened is that many people started doing research related to the crisis because there are opportunities or there is money with this coming in… it has brought some opportunities like the syria lancet commission, which has been great for aub…"(a ) host communities were also considered in both health research and humanitarian interventions which made them benefit from getting access to services that were not prioritized before the syrian crisis, especially services for child protection and those that address gender-based violence. despite providing research opportunities and employment for locals researchers who obtained field experience, an informant highlighted that locals "learned by doing, by being exposed, rather than learning principles of intervention in an academic normal pace setting" (ngo ), which due to the lack of local expertise led to "humanitarian efforts in all of the conflict affected settings in mena to be led by international non-arab experts who do not necessarily understand the context" (ngo ) which might lead to inconsistent interpretations. another factor that was raised by most informants but not considered in the topic guide, was that the basic medical training provided in lebanese universities, does not include treatment of war injuries, trauma, health provision in conflict settings, or health research in such settings. public health professionals are able to conduct research in conflict settings but most medical doctors have limited research skills needed for such a context. clear recommendations regarding more effective health research capacity strengthening interventions that target the individual, organizational and institutional levels were indicated by many informants. regarding better regulation of research, particularly research ethics; workshops on ethical research especially for local ngos were recommended. to address limited coordination between academic bodies and ministries to provide evidence-based policies, roundtables and working groups to discuss priorities of health research with the different stakeholders including policy makers, local ngos, international ngos and academics were thought to be a top priority going forward. "it is important to have a research group to work on setting priorities in order not to have irrelevant research. the results should be then summarized in a policy brief a maximum of pages with direct and simple recommendations to send to policy makers." (m ) in order to have more sustainable funding schemes, it was recommended by most of the informants for research groups to be involved in multidisciplinary and context-specific consortia or research networks like the reproductive health working group and the lancet palestinian health alliance [ ] . those networks would also provide the opportunity of capacity strengthening of researchers via training and mentorship as they go to other countries with advanced technologies to be trained with the latest research developments. capacity strengthening activities for the humanitarian actors and graduates with medical and health backgrounds need to focus on basic qualitative and advanced qualitative and quantitative methods. an informant also added that qualitative research especially going beyond focus groups and interviews and into 'cutting-edge' tools is needed to benefit both communities and researchers (the example given was story-telling as a research method that may also have benefits to research participants). when asked about the type of training to be provided, most informants suggested that accredited certificates in health research methods are highly desirable for all as an incentive for participation. similarly, introducing a module about medical practice in conflict that addresses blast injuries, trauma, and medical practice under severe conditions was also recommended and considered to be an urgent need given the geopolitics of the mena region. when asked about teaching modalities of the certificate, most of the informants highlighted the importance of e-learning which has less burden on both financial and human resources and would be highly appealing especially if it is accredited. however, most agreed on having a blended learning course, rather than purely elearning, which might not provide the most effective learning experience especially to future fieldworkers. an informant also mentioned the possibility of having training that is fully distant but with innovative tools that make the courses more interactive. "i think, it opens doors to expertise that maybe we don't have that you can get from other universities…. i think it is great when you're talking on the theoretical level… but to go from there to design a research study that is a big step …. it saves time, money and human powers and then we can focus the energy on things that need this human interaction." (a ) in this study, we have provided an overview of capacity needs for health research on conflict in lebanon based on strengths and challenges at individual, organizational and institutional levels which are summarized in table . however as these levels are strongly interconnected, any strength or weakness in one of these levels will directly impact the other two levels [ ] . most of the findings are consistent with the international literature on research capacity strengthening in low and middle income countries (lmics) including those affected by armed conflict and political unrest [ , ] . the key themes emerging from this work are categorized below as strengths and challenges of health research which would support the design of impactful research capacity strengthening interventions. one could argue that these strengths and challenges impact research in general and are not limited to health research, with few exceptions including qualitative research designs for health research topics, ethical conduct of health research, and preparedness to practice medicine in conflict settings. therefore, using the same approach, suggested in this study could also improve research in conflict-affected countries at the individual, organizational and institutional levels. however, further research is required to validate this assumption, especially as strengthening research requires more financial and human resources. this would result in additional challenges and constraints where the suggested approaches herein might prove invalid especially that the inclination to health research in low-resource humanitarian-oriented conflict settings might not be applicable to other types of research or for research as a whole. the needs assessment highlighted several enablers within the lebanese context that can contribute towards impactful capacity strengthening interventions. for instance, both researchers (especially early career researchers) and institutions are incentivized to improve their research capacities and outcomes for various reasons. the former is driven by the need to increase their job prospects in a highly competitive job market and the latter to improve their reputation as centers of research given that there are universities in lebanon, one public university hosting , ( %) students and private for-profit organizations hosting , ( %) students that mostly rely on student fees [ , , ] . therefore, despite being a relatively small country in terms of size and population, lebanon has recently been ranked as the third in the east mediterranean region (emr), and mena, after kuwait and tunisia in terms of the number of publications on biomedical and health research per capita [ ] . it is also important to note that there are huge disparities among the universities in lebanon with some being considered as centers of research excellence within the region by contributing most significantly to the country's research outputs and to setting considerable momentum to continuously improving their research capacities. for instance, most of the research outputs originate from the lebanese university, usj and aub with the latter contributing the most and is being ranked the th in biomedical and health research output in emr [ , , ] . lately, the lebanese highly privatized educational system has shown resilience to adversity, at least in the short term. following the country's lockdown to control the spread of covid- , academic institutes have shifted to online learning. vast efforts are underway to provide innovative distant learning approaches that could provide similar levels of academic experience as in face-to-face learning modalities [ , ] . the current attempts to create a reliable online learning platform is an opportunity that can be used for a capacity strengthening intervention to be more inclusive to include those residing in ongoing armed conflicts [ , ] . another opportunity which universities are taking advantage of is the increasing trend of partnerships between local and international academic institutions which increases bidirectional knowledge sharing. for instance the country, along with jordan, morocco and tunisia, has the highest levels of co-authorship in mena [ ] . partnership has already been considered a pillar in capacity strengthening of health research in other settings as it supports collaborative, multidisciplinary and multi-sectoral work which in theory is aimed at addressing power imbalances and inequities [ ] [ ] [ ] [ ] . although lebanon is ranked the th out of for the global gender gap index [ ] , it was interesting to learn that almost all informants, regardless of gender, indicate that the health sector, including research, provides a permissive environment for female researchers to work and advance in their careers (as several deans and vice chancellors of research are women). however, health and education are traditionally considered femalefriendly compared to other sciences technology engineering & medicine (stem) disciplines, so the results reflected in this study cannot be generalized or considered on a larger scale. indeed a recent report on women in academia in the arab world found that women lead fewer than % of higher-education institutions [ ] . thus more research needs to be done on this topic especially that another recent study highlighted a high level of exploitation and alienation of research assistants, who are mostly women, that are working on uk funded research projects focusing on syrian refugees in lebanon. the study emphasized on how the hierarchy in academia, which was also mentioned by few of our informants, could reinforce cultural and academic inequalities including gender [ ] . despite of the variation in the findings and building on the informants' responses, this factor can be considered as an opportunity for both the health research field and the cause of lebanese women in general as having more women in the field in leadership positions will put women's issues at the front of the health research agenda and advocate for more inclusive and diverse research [ ] . despite the opportunities and strengths in terms of human capital, research capacities of certain universities, and the perception of improvement within academia, there are several challenges, besides political and economic instability, that impact health research in lebanon. a factor which was highly expected was the lack of research culture at the country level which limits the impact of any health research despite its importance and relevance to local challenges. unfortunately, this is an issue which the whole region is struggling with as only . % of the global biomedical research output originate from the region [ ] . research culture could be improved and developed by joint efforts between policy makers and the institutes of higher education to provide opportunities for research grants, local and international collaborations, cross-sectoral knowledge transfer, and skill acquisition [ ] [ ] [ ] . it can also be promoted at the community level by publicizing research through the media including social media [ , ] . the issue of research culture leads to the other challenges of health research and its strengthening in lebanon. for instance, there is a problem in crosssectoral knowledge transfer in emr, including lebanon, where there is a lack of both demand for and supply of relevant research which could be attributed to political forces, political sensitivity of findings, limited funding and limited opportunities for interaction during the policy-making process [ ] [ ] [ ] . closing this gap, by engaging policy-makers in setting research agendas to meet their needs, is a key challenge for the health research system where even the best studies are rarely translated into action [ ] [ ] [ ] . in lebanon, there are a few centers that directly engage with policy makers to advocate for evidence-based policies like the lebanese center for policy studies, issam fares institute-aub, global health institute (ghi)-aub and knowledge to policy center (k p)-aub with the last two focusing primarily on health. these centers have been greatly involved lately in issuing policy briefs on political, economic and health system situation in lebanon following the october uprising and the covid- outbreak [ ] [ ] [ ] . the chronic care center (ccc)'s β -thalassemia prevention program that was launched in , in collaboration with mosa and moph, is one of the few examples highlighting the benefits of direct collaboration between policy makers and health and research centres [ ] . key recent evidence use for policy in the country include passing of tobacco control law and introducing a reporting mechanism for occupational violence as part of the accreditation criteria of private lebanese hospitals [ , ] . however, given that in crisis zones four systemspolitical, health, international humanitarian aid and health researchare involved in advocating for evidence use, there is a need for further national level action by engaging multiple stakeholders to set research priorities [ ] . achieving efficient multiple stakeholder coordination will also contribute positively to generating and sharing reliable data across the four systems and with providing additional funding opportunities which would mitigate both of these constraints to health research in lebanon. with regards to funding, according to the cnrs, the country allocated only . % of its gross domestic product (gdp) for research and development in [ ] . as a result, universities in the country rely primarily on international funding schemes to support their research activities along with allocating part of their budgets for this purpose. the amount of money allocated varies remarkably among the universities in lebanon with aub being the lead, followed by the lebanese university and usj [ ] . it is due to external funding that the universities in lebanon are focusing on conflict and health research as it is an agency research priority [ ] . given the current drastic economic situation of the country, it is expected that universities will depend even more on international funding resources as they might not be able to allocate the same percentages of their budgets to fund research given that the number of registered students in private universities will severely decline. thus, the issue of sustainable funding of health research remains unresolved until the lebanese government is capable of adopting a research strategy that supports health research at the national scale. another serious issue, ethics in research, which was highlighted in this study is also linked to cultural factors. in the mena region, and lebanon, there is a strong collective orientation where the community plays a significant role in an individual's life; resultantly achieving informational and decisional privacy of research participants could be challenging [ ] . obtaining consent, in its western notion, from populations with multiple vulnerabilities such as syrian refugees is also problematic given the coercive societal dynamics and context. so despite a thorough irb process, conducting refugee research in practice remains ethically challenging [ ] . nonetheless, lebanon lacks a unified system of research governance, and hence research regulation is greatly influenced by the policies of individual institutions and their irbs [ , ] . obtaining unified guidelines of ethical research in lebanon faces multifaceted complications so a direct and short-term mitigation plan would be to train fieldworkers working with local ngos to understand better the concepts of privacy, confidentiality and consent while still adhering to the lebanese context. interdisciplinary research is crucial in understanding and resolving complex public health problems especially in conflict [ , ] . qualitative and quantitative research methods are required to provide an enhanced understanding of the causes and consequences of conflicts while emphasizing personal experiences and narratives of those struggling from these conflicts is important [ , ] . however, interdisciplinarity is not a strength in health research in lebanon despite having few funding opportunities for such initiatives [ , ] . human and social science research is significantly ignored as a research study indicated that only % of cnrs and % of aub research support goes to this field [ ] . qualitative research skills, at both undergraduate and postgraduate levels, appears to be a central weakness in the lebanese educational system. in addition, students with social sciences background also struggle with quantitative research skills. such weaknesses vary significantly depending on the university's teaching and research capacity which, as highlighted earlier, vary tremendously. the concentration of research in few private universities, with relatively high tuition fees, limits the opportunity of graduates from other universities, and from more diverse socio-economic backgrounds, to be trained in conducting conflict and health research of high quality. this heterogeneity in health research training can be mitigated if graduates, regardless of their alma mater, are provided with extra-curricular/ stand-alone courses on interdisciplinary research methods in conflict that are suitable for a wide range of participants from different academic backgrounds. while the initial focus was mainly on health research in conflict, this study also exposed a new fragility within the medical curriculum in the country. medical graduates are not prepared to practice in conflict settings despite the fact that the region, including lebanon, is highly vulnerable to instability [ ] . taking into consideration that any changes in the medical curricula across lebanon would be challenging due to logistics and difficulties in reobtaining accreditation from the ministry of higher education, specific postgraduate training could fill this gap by introducing training that focuses on medical practice in conflict settings. this would be taken by individuals interested in practicing in conflict-affected humanitarian settings across the mena. the international committee of the red cross (icrc) has war surgery courses which could benefit local practitioners [ ] ; however, these courses are limited in scope as they focus exclusively on medical students at the lebanese university. despite this study's focus on lebanon, the challenges and strengths of the country's health research capacities presented herein are in accordance with similar studies that focus on health research in the mena/emr region especially in conflict-affected settings. the recent work of alkhaldi et al. that focuses on research capacity strengthening in palestine, also revealed that health research capacities in the country are relatively weak despite the recent increase in health research production. guidelines for health research quality and standardization are not adhered to due to a lack of policies and resources, and health research knowledge transfer is a major challenge that requires contextualization and adequate implementation [ ] . regarding research skills, a needs assessment focusing on the west bank, palestine, published by r hc-mena colleagues, found that most of the respondents considered that they have a significant gap in their abilities and understanding of coding and analysis of qualitative data, and planning and designing research [ ] . this is also supported by our study's findings in terms of the need to focus more on qualitative research designs in lebanon. moreover, a recent bibliometric study focusing on research activity on non-communicable diseases (ncds) in the mena found that there has been an increase in research activity in the region that is heterogenous with respect to wealth, population size and type of ncd but with no clear correlation to the corresponding disease burden. the study suggested that international collaborations can support overcoming problems such as a lack of suitably trained researchers, low political commitment, and poor financial support; all of which have been indicated in our study [ ] . similarly, the paucity in health research and training which are contextualized to conflict settings is also a wider mena region problem as "emergency preparedness" is one of the least studied fields in the emr/mena regions- . % journal papers published in the field of public health research between and [ ] . one of the main limitations is perhaps that the findings may not be generalizable outside the lebanese context, although a follow-up comparative study focusing on mena would enable broader interpretations of the key research objectives. however, the high level of consistency from the key informant interviews of the same participant type and the similarity between the findings of this work to those of quantitative studies focusing on health research in the mena provided meaningful context. another limitation is that most of the refusals or unanswered invitations were from the public sector informants. therefore, there might be other themes that would be more relevant to the public sector that this study did not reflect due to the low number of participants from the public sector. however, those interviewed provided similar feedback to that of the other categories. promoting inter-sectoral communication, which is one of the major recommendations of this study, would mitigate this problem in future research as more informants from the public sector will be more willing to participate in research activities. in summary, the study revealed that health research in lebanon is characterized by considerable strengths in terms of human capital and research capacities of certain universities. however, there was considerable concern regarding research ethics among most informants, and workshops on ethical research especially for local ngos were recommended. guaranteeing sustainable funding of conflict and health research which was highlighted as a major challenge is problematic given the current economic crisis of the country and its lack of research strategy at the national level. thus strengthening partnerships with international collaborators is the only way to secure funding at least in the short run. the impact of research on policymaking was also another recurring theme where organizing roundtables to discuss priorities of health research with the different stakeholders was suggested as a way forward. for strengthening research capacity at the individual level, a great amount of interest around research methodology, conceptualizing and design was expressed. moreover, providing knowledge about medical practice and dealing with war injuries was also considered as a need to fill the gap in the medical training provided at universities that do not currently focus on this aspect in medical training. accredited certificates were considered as an incentive for participation and a combination of elearning and mentorship was identified as having the most potential impact. these findings will be useful for guiding research capacity strengthening approaches within large international projects that will include developing academic courses, engaging with ngos and policymakers to improve capacities for conducting useful research, and delivering trainings on health research skills in conflict settings. the study herein, supported by qualitative research methods, provides comprehensive insight and complements the findings of several quantitative bibliometric analyses of health and biomedical research in lebanon and the wider mena region [ , , , ] . supplementary information accompanies this paper at https://doi.org/ . /s - - -x. world health organization, the who strategy on research for health an evidence review of research on health interventions in humanitarian crises. london: 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a higher education institution ways to promote better research culture how researchers use social media to promote their research and network with industry what can the media do for researchers? use of health systems evidence by policymakers in eastern mediterranean countries: views, practices, and contextual influences assessing the state of health research in the eastern mediterranean region engagement of health research institutions in knowledge translation in the eastern mediterranean region an approach for setting evidence-based and stakeholder-informed research priorities in low-and middle-income countries how to engage stakeholders in research: design principles to support improvement the dos and don'ts of influencing policy: a systematic review of advice to academics covid- ): knowledge to policy (k p) & global health institute (ghi): aub; lcps. lcps: the lebanese center for policy studies. beirut; fares institute for public policy and international affairs β-thalassemia: the lebanese experience the passage of tobacco control law in lebanon: reflections on the problem, policies and politics a national study on nurses' exposure to occupational violence in lebanon: prevalence, consequences and associated factors supporting the use of research evidence in decision-making in crisis zones in low-and middle-income countries: a critical interpretive synthesis assessing subject privacy and data confidentiality in an emerging region for clinical trials: united arab emirates ethical, methodological, and contextual challenges in research in conflict settings: the case of syrian refugee children in lebanon review of national research ethics regulations and guidelines in middle eastern arab countries the practice of research ethics in lebanon and qatar: perspectives of researchers on informed consent interdisciplinary working in public health research: a proposed good practice checklist reframing public health in wartime: from the biomedical model to the "wounds inside mixed methods research in the study of political and social violence and conflict daad. foreign + foreignness: interdisciplinary research in the bekaa. beirut: daad announcing the sheikh khaldoun bakri barakat-ibsar research fund for interdisciplinary research in the natural and social sciences medical schools in times of war: integrating conflict medicine in medical education training needs assessment for mental health research in war and conflict: the west bank, occupied palestinian territory. birzeit: r hc-mena the profile of non-communicable disease (ncd) research in the middle east and north africa (mena) region: analyzing the ncd burden, research outputs and international research collaboration we would like to thank ms. marilyne menassa for her technical assistance.authors' contributions ne has led the data collection, analysis, and interpretation and wrote the first draft of the manuscript. gha has contributed substantively to data analysis and interpretation. ar contributed to data collection and wrote sections in the manuscript. ek has contributed to data interpretation. ap designed the topic guide for the semi-structured interviews. ap, km and ae provided critical feedback and helped shape the manuscript. pp, gha and gas critically reviewed the manuscript. pp oversaw the project, contributed with literature, and provided analytical feedback for the discussion of the paper. all authors have read and approved the final manuscript. the datasets generated and analysed during the current study are not publicly available due to them containing information that could compromise research participant privacy/consent but are available from the corresponding author on reasonable request.ethics approval and consent to participate ethical approval to conduct key informant interviews for the study was granted by ethical review committee at the american university of beirut on january (reference number sbs- - ). we obtained consent from all participants either verbally or by email. we anonymized all transcribed interviews. the consent included the acceptance to participate in the study and for the data retrieved to be presented in publication in an anonymized format. not applicable. the authors declare that they have no competing interests. publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -de aimuj authors: revere, debra; nelson, kailey; thiede, hanne; duchin, jeffrey; stergachis, andy; baseman, janet title: public health emergency preparedness and response communications with health care providers: a literature review date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: de aimuj background: health care providers (hcps) play an important role in public health emergency preparedness and response (phepr) so need to be aware of public health threats and emergencies. to inform hcps, public health issues phepr messages that provide guidelines and updates, and facilitate surveillance so hcps will recognize and control communicable diseases, prevent excess deaths and mitigate suffering. public health agencies need to know that the phepr messages sent to hcps reach their target audience and are effective and informative. public health agencies need to know that the phepr messages sent to hcps reach their target audience and are effective and informative. we conducted a literature review to investigate the systems and tools used by public health to generate phepr communications to hcps, and to identify specific characteristics of message delivery mechanisms and formats that may be associated with effective phepr communications. methods: a systematic review of peer- and non-peer-reviewed literature focused on the following questions: ) what public health systems exist for communicating phepr messages from public health agencies to hcps? ) have these systems been evaluated and, if yes, what criteria were used to evaluate these systems? ) what have these evaluations discovered about characterizations of the most effective ways for public health agencies to communicate phepr messages to hcps? results: we identified systems or tools for communicating phepr messages from public health agencies to hcps. few articles assessed phepr communication systems or messaging methods or outcomes. only one study compared the effectiveness of the delivery format, device or message itself. we also discovered that the potential is high for hcps to experience "message overload" given redundancy of phepr messaging in multiple formats and/or through different delivery systems. conclusions: we found that detailed descriptions of phepr messaging from public health to hcps are scarce in the literature and, even when available are rarely evaluated in any systematic fashion. to meet present-day and future information needs for emergency preparedness, more attention needs to be given to evaluating the effectiveness of these systems in a scientifically rigorous manner. public health emergency preparedness and response (phepr) involves activities directed at preventing possible emergencies and planning to ensure an adequate response and recovery if an emergency occurs. the public health system itself is a complex network of organizations and individuals that work together for the benefit of the public's health. these entities include public health agencies at local, state and federal levels, public safety agencies, emergency managers, academia, business, communities, the media, and the healthcare delivery system [ ] . as one component of the phepr system, information contributed by health care providers (hcps) to public health is aggregated, analyzed and used by public health agencies, in part, to inform early event detection and situational awareness [ ] . figure illustrates a simplified transfer of information from hcps to public health which is aggregated, analyzed and used to inform public health alerts and advisories which are sent to hcps. the importance of the transmission of hcp information to public health, particularly for notifiable condition reporting, has been well-documented [ ] [ ] [ ] [ ] . hcps serve a critical role in public health's recognition and control of communicable diseases as illustrated by west nile virus [ ] and sars [ ] ; influenza and influenza-like illness [ ] ; foodborne illnesses [ ] ; and illnesses associated with intentional release of biologic agents such as anthrax [ , ] . in public health responses involving bioterrorism, hcps have an especially important role since they will likely report such cases of unexplained or unusual illness to state and local public health officials who, in turn, may be able to conduct investigations and identify specific epidemiologic patterns or characteristics potentially indicative of bioterrorism [ ] . during an emergency situation health care providers (hcps) are depended on to prevent excess deaths, treat the injured, and mitigate suffering [ ] . to do this, and given that individuals will seek medical care in multiple locations during an emergency, hcps need to be aware of public health threats and emergencies, issue guidelines and updates, and facilitate surveillance [ ] . on september , , when telephone and paging systems failed, the new york city department of health and mental hygiene successfully used email and fax to distribute public health broadcast alerts to all nyc emergency departments, commercial and hospital laboratories, infection-control programs, and select providers [ ] . in an emergency, effective communication will not only depend on the information/message, but on the type of communication system or tool, the delivery format, and the robustness of the system. while timely, efficient, and effective communications between public health and hcps is an important part of public health emergency preparedness and response (phepr), most publications concerned with this exchange have emphasized the hcp-to-public health component. yet, it is well-established that the "return" of information to hcps is also significant. we conducted a systematic literature review to investigate the systems and tools used by public health to generate phepr communications to hcps, and to identify specific characteristics of message delivery mechanisms and formats that may be associated with effective phepr communications. three questions guided this literature review: what public health systems exist for communicating phepr messages from public health agencies to hcps? have these systems been evaluated and, if yes, what criteria were used to evaluate these systems? what have these evaluations discovered about characterizations of the most effective ways for public health agencies to communicate phepr messages to hcps? table lists the subject terms and keyword terms identified for key concepts for the search. to ensure retrieval of different types of phepr messages we included both health alerts (messages of the highest level of importance that warrant immediate action or attention) and health advisories (messages that provides key information for a specific incident or situation, such as a guideline change, and might not require immediate action). we also included as search terms any system, communication method or device that facilitated these communications. public health literature is reported to be poorly indexed in bibliographic databases and dispersed across a wide variety of journals and other sources, as well as across many disciplines [ ] . we included "grey" or non-peer-reviewed literature sources [ ] to ensure wide coverage of less accessible materials such as government reports and conference proceedings ( table ) . the exact search terminology used was tailored for each database as appropriate to its structure and thesaurus to ensure a high degree of sensitivity ( table ) . the web of science ® database was used to conduct cited reference searches of relevant articles. in addition, we hand-searched (known as snowball sampling) the reference lists of relevant articles and the tables of contents of the following journals: journal of homeland security and emergency management, disaster medicine & public health preparedness, and american journal of disaster medicine. the review was limited to publications in the english language and to materials published between / through / . all search strategies were recorded at each step. citations from database searches were downloaded into the endnote bibliographic reference program (http://www.endnote.com/) or manually entered as needed. duplicates were removed. figure illustrates the identification, screening, eligibility and inclusion numbers, and rationale for excluded materials in our search and selection process [ ] . articles were included if they described systems or tools for public health agencies to communicate phepr messages to hcps or included an evaluation of these systems or tools. data extracted from the articles included: purpose, location, organization or agency involved, hcp population, method(s) of communication, and type of evaluation performed, if conducted. if an evaluation was performed, the outcomes were extracted. of the initial set of full-text articles assessed for eligibility, were excluded once read as they only described systems that sent phepr messages to health departments (n = ) or were opinion articles (n = ). data extraction from the final articles resulted in identification of different systems, with one article describing more than one system. overall, the final articles contained information on the purpose of the system or tool ( %), location of the system ( %), public health organization or agency involved ( %), targeted hcp population ( %), and method(s) used by public health to communicate phepr messages to hcps ( %). eleven articles (covering systems) included a description of the evaluation used with the system. type of evaluations included comparative [ ] , interviewing [ ] , surveying [ , ] , retrospective [ , ] , formative [ ] , and an assessment following a simulation exercise [ ] . one article reported a causal relationship could be "inferred" between the dissemination of health advisories and hcp reporting and testing [ ] and two reported receiving feedback but did not detail method [ , ] . the remaining articles ( %) either did not mention an evaluation or did not contain enough information to determine if an evaluation had been conducted. of the systems and tools documented, the majority ( %) were north america-based. the location of the systems included: % state-level, % city-level, % country-level, and % regional, with one international system ( %). only one tool was designed to provide phepr messages to veterinarians; the remaining targeted hcps in hospitals, emergency departments and/or outpatient clinical settings. the majority of systems used email ( %) to deliver phepr messages. systems also delivered messages by phone, including cellular ( %); fax ( %); pager ( %); sms text messaging ( %); handheld devices such as pdas or blackberry ® ( %); other devices such as radios ( %); messaging through an electronic medical record "public health" pandemic "health alert" or "public health alert" veterinarians preparedness "health advisory" terrorism "preparedness message" surveillance "preparedness communication" system ( %); and "social media" ( %). some systems also posted the phepr message to a web site ( %) for passive consumption. a majority of systems used more than one method ( %) for delivering messages. only systems were described in sufficient detail to determine that each method was attempted sequentially as opposed to redundant messages being delivered through all devices and formats. table (additional file table s ) lists each messaging system or tool included in the final retrieval set and indicates type of evaluation conducted where applicable. after conducting a systematic search, we identified systems or tools currently being used to communicate phepr messages from public health to hcps. of the systems that reported an evaluation, only provided sufficient detail of methodology used. during a q fever outbreak, two public health alert faxes were sent asking physicians to submit serum samples on any patient meeting a clinical case definition of q fever and an association with the area where the outbreak occurred. by examining laboratory reports, van woerden et al ( ) found a statistically significant difference between the number of patients tested for q fever in the target population after the alerts had been sent as compared to a comparable two-week period one year before [ ] . another study retrospectively examined recommended public health agency actions communicated to hcps through a pop-up in an electronic health record in comparison with lab orders and treatment guidelines and found that a causal relationship "could be inferred" (although with no detail to document this inference) between the alert and a change in hcp behavior [ ] . other system evaluations lacked adequate detail to determine the extent of evaluation activities. prior to developing germwatch, a system focused on communicating advisories regarding respiratory viral pathogens and pertussis, gesteland et al ( ) conducted a formative evaluation of the feasibility and sustainability of the system [ ] . however, formative studies, though useful in the planning and early development phases of a system, need to be followed up with an evaluation focused on identifying changes in outcome or performance measures, results, or effectiveness criteria that can be confidently attributed to the system rather than other factors and conditions. while reports of retrospective evaluations of promed, a global outbreak surveillance system [ , ] , the messaging tools used in conjunction with a topoff exercise [ ] , and a survey of homeless service providers during the sars outbreak in toronto [ ] identify problems and propose measures to counteract problematic communications issues between public health and hcps, the reports lacked the detailed methodology or results that are needed to assess the rigor of these evaluations. ("public health") and (doctors or physicians or nurses or pharmacists or veterinarians or "healthcare providers" or "health care providers" or surveillance) and (communication or "emergency communication" or "disease event" or "health alert" or "public health alert" or "emergency alert") and (emergency or disaster or terrorism or pandemic or preparedness or response or "disease outbreak") medline inspec ("public health" or "emergency services" or "emergency preparedness" or "emergency planning" or "surveillance activity" or "emergency response") and alert web of science ("public health" and (doctors or physicians or nurses or pharmacists or veterinarians or "healthcare providers" or "health care providers" or surveillance) and (communication or "response capacity" or "emergency communication" or "disease event" or "health alert" or "public health alert" or "emergency alert") and (emergency or disaster or terrorism or pandemic or preparedness or response)) snowball technique hand-searching article references, related records, tables of contents of pertinent journals ahrq "public health" and "emergency preparedness" and alert cdc "public health" and "emergency preparedness" and "emergency communication" gpo access "public health" and providers* and communication and emergency "public health" and terrorism and alert nlm gateway "public health" and "bidirectional communication" and "health alert" rand "public health" and disaster and providers* and alert one of the most widespread strategies in the u.s. for public health agencies to communicate to hcps on both national and local levels is through the cdc's health alert network (han) program which communicates information about infectious disease outbreaks and public health implications of national disasters within its health alerts, advisories, and updates [ , , ] . given its wide coverage, we were surprised to find so few studies attempting to systematically verify that han messages are received, processed, and/or acted upon by the intended recipients outside of public health agencies. as a result, in part, of current studies of the h n outbreak, we are now learning that phepr messages may not be reaching their targeted audiences. for example, results of a cross-sectional survey of health departments, physicians, and pharmacists in kentucky regarding information dissemination and receipt during the early h n outbreak found that deficiencies exist in the effectiveness of public health phepr communications to hcps. while % of responding local health departments (lhds) rated their capacity to disseminate information to hcps as very good or excellent, only % of surveyed physicians and % of surveyed pharmacists reported receiving any information about h n from a lhd. seventy-four percent of pharmacists were not aware of their lhd's emergency plan in the event of an influenza outbreak [ ] . in conducting this review we discovered that there are multiple sources from which hcps may receive han communications. cdc not only sends messages to state and local public health agencies that then disseminate to hcps, but clinicians can also sign up to receive han messages directly through the cdc's clinician outreach communication activity (coca) as well as through any of the coca partner organizations that pass on or post coca-generated notices of new and updated cdc information on emerging health threats [ , ] . while any phepr situation presents challenges in communicating about uncertainties, collaborating across and within organizations, and communicating timely messages [ ] , every additional messaging source raises the potential for redundant and conflicting information. coca disseminates updates bi-weekly (more frequently when there is emergency information or event-specific updates). excluding han alerts, a tally of messages disseminated through coca from - yielded messages that each contain as many as topical messages. avoiding the communication of multiple and redundant messages that can engender "alert overload" in hcps is important, especially in a public health emergency situation. the han system allows hcps to set a preference for receiving messages but, as mentioned above, if the hcp is receiving messages from different sources the redundancy potential increases. staes et al ( ) presented an objective analysis of communication between public health agencies, health care organizations, and frontline hcps during the h n outbreak. the investigators conducted a cross-sectional survey to understand communication processes between public health and frontline hcps and found that hcps received redundant messages; were challenged to keep up with evolving and tailored messages from multiple organizations at a time when clinic volumes, patient concerns, and media exposure were increasing; and were overwhelmed by e-mail volume. the study suggests that phepr messages sent to hcps be concise and clearly identified [ ] . we found there are numerous formats (email, fax, etc) in which to deliver phepr messages to hcps. when more than one format was available it was not clear if hcps were given a choice between different ways to receive messages as opposed to receiving redundant messages in different formats or through different delivery systems. allowing hcps to set preferences for receiving phepr messages might improve response. our review has three main limitations: ) scope and search terms; ) access to full-text articles; and ) lack of data in the included articles. for practical reasons we limited ourselves to materials written in the english language. while we did not limit ourselves to u.s. systems or studies, it is possible that systems of phepr messaging to hcps developed in europe and asia may be written in other languages. it is also possible that our search strategy did not cast either a wide or targeted enough net to capture relevant literature. perhaps modifications to the terminology or concept operators would have yielded better retrieval sets. we were limited to resources accessible through our academic libraries and their inter-library partnerships so may have missed some material. another limitation is our elimination of articles missing or with uninformative abstracts. again, it is possible that this omitted key articles from our results. lack of data was an issue as many articles did not contain sufficient descriptive information. despite these limitations, our results show that detailed descriptions of phepr messaging from public health to hcps are scarce in the literature and, even when available are rarely evaluated in any systematic fashion. this review shows that little is known about the effectiveness of phepr communications from public health to hcps. we also found that by using multiple formats and delivery methods, current systems and tools may be increasing, rather than reducing, communication challenges for hcps with unnecessarily redundant messages; confusion due to messages that may reflect conflicting federal, state and local guidelines, information and concerns; alert "overload"; and lack of tailored preferences for receiving these important messages. much has been written about the "astute clinician" who noted an unusual clinical finding and set off the public health alarm concerning the first case of anthrax in palm beach county, florida in october [ ] . given the importance of hcps in phepr, more research needs to be done to further investigate how public health can communicate effectively with hcps. there are numerous questions about these systems and tools that need to be answered, some basic, such as: have phepr messages been successfully delivered? were they read and, if yes, can the date or time of their delivery and their content be recalled? is there an optimal frequency for sending phepr messages? what components of a message are most important for the message to be perceived as credible, authoritative, complete? what impact do phepr messages have on hcp behavior, surveillance or reporting of suspected or confirmed events of public health interest or phepr knowledge? one example of new research being conducted in this area is the reach trial in which the authors are using a randomized, community-based trial method to investigate the effectiveness of various message delivery systems (email, fax, and sms) for communicating phepr messages from public health agencies to hcps [ ] . the primary aim of reach is to determine the effectiveness of various message delivery systems (email, fax, and sms) for communicating phepr messages from public health agencies to hcps and to compare the effectiveness of communication methods between these two groups across diverse communities. this is however, only one effort. to meet present-day and future information needs for emergency preparedness, concentrated attention needs to be given to evaluating the effectiveness of phepr systems in a scientifically rigorous manner [ ] . additional file : table s : literature selected. iom: the future of the public's health in the st century will the nation be ready for the next bioterrorism attack? mending gaps in the public health infrastructure the bioterrorism preparedness and response early aberration reporting system (ears) evaluation of reporting timeliness of public health surveillance systems for infectious diseases syndromic surveillance using minimum transfer of identifiable data: the example of the national bioterrorism syndromic surveillance demonstration program the west nile virus encephalitis outbreak in the united states severe acute respiratory syndrome (sars) and coronavirus testing-united states outbreak of swine-origin influenza a (h n ) virus infection -mexico surveillance for foodborne disease outbreaks -united states emergency department visits for concern regarding anthrax-new jersey death due to bioterrorism-related inhalational anthrax: report of patients the role of an advanced practice public health nurse in bioterrorism preparedness bioterrorism preparedness and response: clinicians and public health agencies as essential partners the health alert network: partnerships, politics, and preparedness new york city department of health response to terrorist attack expert searching in public health the use of grey literature in health sciences: a preliminary survey preferred reporting items for systematic reviews and meta-analyses: the prisma statement using facsimile cascade to assist case searching during a q fever outbreak homelessness and the response to emerging infectious disease outbreaks: lessons from sars the novel influenza a h n epidemic of spring evaluation of promed-mail as an electronic early warning system for emerging animal diseases: to the internet and the global monitoring of emerging diseases: lessons from the first years of promed-mail informing the front line about common respiratory viral epidemics terrorism preparedness: web-based resource management and the topoff exercise using electronic health record alerts to provide public health situational awareness to clinicians local collaborations: development and implementation of boston's bioterrorism surveillance system novel h n and the use of hit within the chicago department of public health exemplary practices in public health preparedness. technical revere et al. bmc public health communication efforts among local health departments and health care professionals during the h n outbreak order out of chaos: the self-organization of communication following the anthrax attacks public health communication with frontline clinicians during the first wave of the influenza pandemic bioterrorism-related inhalational anthrax: the first cases reported in the united states. emerg infect dis improving public health to provider messaging: the reach project. joint conference on health iom: research priorities in emergency preparedness and response for public health systems: a letter report pre-publication history the pre-publication history for this paper can be accessed here public health emergency preparedness and response communications with health care providers: a literature review the authors would like to thank the bmc public health reviewers for their insightful comments and suggestions. this work was supported by the centers for disease control and prevention, grant no. p tp . its contents are solely the responsibility of the authors and do not necessarily represent the official views of the centers for disease control and prevention. authors' contributions dr conceived of and led the search, evaluation and synthesis components. kn participated in the database searches and retrieval set evaluation. dr authored the overall manuscript with contributions by kn, jb, as, ht and jd. all authors read and approved the final manuscript. the authors declare that they have no competing interests. key: cord- -m sr oc authors: denburg, avram e.; ungar, wendy j.; chen, shiyi; hurley, jeremiah; abelson, julia title: does moral reasoning influence public values for health care priority setting?: a population-based randomized stated preference survey date: - - journal: health policy doi: . /j.healthpol. . . sha: doc_id: cord_uid: m sr oc objective: preferences of members of the public are recognized as important inputs into health care priority-setting, though knowledge of such preferences is scant. we sought to generate evidence of public preferences related to healthcare resource allocation among adults and children. methods: we conducted an experimental stated preference survey in a national sample of canadian adults. preferences were elicited across a range of scenarios and scored on a visual analogue scale. intervention group participants were randomized to a moral reasoning exercise prior to each choice task. the main outcomes were the differences in mean preference scores by group, scenario, and demographics. results: our results demonstrate a consistent preference by participants to allocate scarce health system resources to children. exposure to the moral reasoning exercise weakened but did not eliminate this preference. younger respondent age and parenthood were associated with greater preference for children. the top principles guiding participants’ allocative decisions were treat equally, relieve suffering, and rescue those at risk of dying. conclusions: our study affirms the relevance of age in public preferences for the allocation of scarce health care resources, demonstrating a significant preference by participants to allocate healthcare resources to children. however, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access. definitions of value in healthcare based on clinical benefit and cost-effectiveness may exclude moral considerations that the public values, such as equality and humanitarianism, highlighting opportunities to enrich healthcare priority-setting through public engagement. faced with both scarce resources and pressures to keep pace with innovation, health systems in most developed nations emphasize the comparative value of health interventions in payment policies and coverage decisions [ , ] . such appraisals of value rely on assessments of clinical efficacy, economic efficiency and, increasingly, societal values. growing recognition that democratic commitments warrant more room for public voice in health and social policy decisions particularly when allocating public resourceshas spurred attempts to incorporate citizens' values and preferences in health technology assessment (hta) in an increasing number of developed countries [ ] . while approaches to measuring clinical and economic value are wellspecified, the means of identifying and assimilating relevant societal values in hta are not [ , ] . to bridge this gap, a growing academic literature has sought to address the measurement and interpretation of societal value judgements for health system priority setting. two contrasting approaches to the elicitation of societal values have prevailed: population-based surveys and exercises in deliberative engagement. both admit of strengths and limitations. while survey methods are able to elicit preferences from a large swath of the public, they often preclude in-depth reflection and discussion about the complex ethical issues involved in setting priorities [ , ] . by contrast, deliberative engagement with patients or publics offers rich opportunities for nuanced and recursive consideration of the values that motivate allocative decisions, but from the bounded perspective of a small and select group of persons [ ] . a few attempts have been made to marry deliberative and survey methods, either by bookending deliberative events with survey questions or by embedding opportunities for deliberation within survey designs [ ] [ ] [ ] . we adapt an approach to the latter to investigate societal preferences for allocating health care resources to children as compared to adults. age represents one of the most prominent issues explored in the literature on social values for health system resource allocation [ ] [ ] [ ] [ ] [ ] [ ] . the focus on age stems in part from the utilitarian assumptions that anchor prevailing methods of health economic evaluation [ , ] . qualityadjusted life years (qalys) have played a dominant role in assessing the value of health interventions, as a universal metric for comparisons of benefit among different technologies that incorporate quantity and quality of life into a unified indicator. closely allied to the use of qalys as an outcome measure in applied health economic evaluation is the assumption of utilitarian qaly maximization as a normative goaland thus decision-criterionwhen selecting the best alternative among competing interventions [ ] . the prominence of qaly maximization as a decision-criterion in applied health economic evaluation, including by hta institutions internationally, has prompted theoretical and empirical inquiry into the strength of societal preference for qaly maximization [ ] [ ] [ ] [ ] . moral philosophers and social choice theorists have challenged the moral legitimacy of purely consequentialist approaches to health care rationing, including qaly maximization, citing the relevance of ethical concepts ranging from distributive justice, priority to the worst off, and rightsbased entitlements in health resource allocation [ ] [ ] [ ] [ ] [ ] [ ] . empirical studies of public preferences for health care resource allocation often employ recipient age as a proxy for qaly gains. studies of public preferences have yielded considerable evidence favouring priority to younger populations [ ] [ ] [ ] [ ] . such studies have often compared adults of various ages; select studies include a childhood age range among their comparators ( , ( ) ( ) ( ) ( ) . however, few studies have explored public preferences for health resource allocation decisions related to children as such. underlying societal preferences for health resource allocation: ) 'health maximization ageism' (constant relative value of life-years, irrespective of age); ) 'productivity ageism' (higher value of life-years in young adulthood, related to greater social and economic productivity); and ) 'fair innings ageism' (emphasis on opportunity for equal aggregate lifetime health (or qalys) through priority to those expected to experience less, such as the young or disadvantaged) ( ) . each of these approaches is outcome-oriented and concerned with health gains, though calibrated to prioritize different groups based on alternative ethical arguments. 'health maximization ageism', which corresponds to pure qaly maximization, receives its strongest support in age-based stated preference studies that focus on life-saving interventions, or those that result in more aggregate qalys for younger recipients. even so, evidence for societal disavowal of pure qaly maximization exists, with some studies yielding majority preferences for equal allocation in the face of discrepant potential qaly gains across age groups ( , ) . importantly, studies that test preferences for age-based allocation in terms of qaly maximization alone cannot discern whether distinct moral principles inducing priority to the young (be it children or younger adults) are at play. when controlling for qalys gained, the evidence in support of priority to younger groups is mixed. stated preferences consistent with both 'fair innings ageism' and 'productivity ageism' are evident in select studies examining age-based trade-offs in the context of fixed benefits. when the duration of benefit across age groups is standardizedthereby in effect neutralizing 'health maximization ageism', or pure qaly maximizationconsistent prioritization by age breaks down, with participants alternately preferring allocation to children, people in middle age, or equal allocation across age groups ( ) ( ) , ( ) ( ) . it is, however, often difficult to disentangle evidence in support of one of these forms of ageism from the other in the extant literature. in addition to studies of age-based priority setting that focus on health outcomes, a number of studies explore the moral bases for allocative decision-making by examining the relevance of causes. anand and wailoo demonstrate weak societal preference for consequentialist rationing rules, including qaly maximization, through experimental rationing decisions that force tradeoffs between hypothetical adult recipients of different ages ( ) . notably, they also empirically examine the relevance of deontological considerations in health care rationing, including personal responsibility for one's health state, socioeconomic status, and procedural considerations in priority setting. their work demonstrates a disavowal by participants of pure qaly maximization, and highlights other salient normative considerations for potential incorporation into rationing exercises, including equality of treatment, individual rights and duties, and procedural fairness ( , ) . relatedly, a limited body of evidence points to the impact of embedded moral reasoning on attenuated public preference for the young, suggesting that deliberation on a range of ethical principles can influence stated preferences for allocating resources based on age ( ) . however, this evidence pertains to age variations amongst adults. j o u r n a l p r e -p r o o f despite this focus on age as a morally relevant variable, the extant literature contains little dedicated inquiry into allocative preferences regarding children per se ( ) . this lack of evidence has contributed to a vacuum of both theoretical and context-specific knowledge about societal preferences related to the prioritization of health system resources for children. the need for more and better knowledge of public values attached to health care priority-setting affecting children is underscored by inherent challenges associated with the assessment of child health technologies [ ] [ ] [ ] . health system funding decisions for children are often constrained by limited evidence for the clinical efficacy or economic efficiency of child health technologies [ ] . childhood diseases are typically rare, the conduct of research in pediatric populations is complex, and standard metrics of clinical and economic assessment fail to incorporate unique dimensions of childhood, such as family context and life-course impacts [ , ] to better understand societal values for health resource allocation, we conducted a population-based stated preference survey with a nested randomized controlled moral reasoning intervention. our objective was to generate evidence to inform economic evaluation and policymaking on health care priority-setting and payment reform in developed health systems. uniquely, we sought to explicitly assess societal preferences for allocation to children, and to test j o u r n a l p r e -p r o o f the influence of structured deliberationin the form of an individual-level moral reasoning exerciseon allocative preferences. our principal aims were to: ( ) understand the direction and strength of public preferences for health resource allocation between children and adults for varied treatment scenarios, ( ) assess the impact of a moral reasoning intervention on the expression of such preferences, and ( ) identify sociodemographic factors that impact the expression of public preferences on health resource allocation between children and adults. we also sought to test the divergence of participant preferences for children or adults from an assumption of age-neutrality, to understand the treatment scenarios within which significant preferences for either children or adults emerge. finally, we aimed to characterize the principles that most influenced participants' allocative decisions, to gain a deeper understanding of the moral reasoning behind societal preferences for health resource allocation. in keeping with much of the prior literature on age-based resource allocation, we expected that control group participants would display an aggregate mean preference for allocation to children, particularly in scenarios where theoretical qaly gains were largest (i.e. cancer treatment and eating disorders therapy). in scenarios with fixed and equal life-year gains across children and adults (i.e. chronic disease drug, liver transplant), we hypothesized that participant preferences for children would be less pronounced, but persist on average, due to intuitive conceptions of 'fair innings'. we included a palliative care scenario to test the direction and strength of age-based preferences in a context focused on relief of suffering rather than hypothetical qaly gains, anticipating weak or no preference for allocation to children. in terms of participant sociodemographics, we presumed that younger adults and those with children of their own would j o u r n a l p r e -p r o o f preferentially favour allocation to children, due to temporal and emotional proximity to childhood states. in contrast to prior evidence demonstrating diminished preference for younger adults induced through moral deliberation [ ] , we hypothesized that a moral reasoning exercise would increase the strength of public preference for allocation to children, as compared to adults. this hypothesis was predicated on insights from foregoing normative analyses of public policies for children, which have identified distinguishing characteristics of childhoodsuch as vulnerability, dependency, rarity, social distinction, and future potentialas drivers for policy development [ ] [ ] [ ] [ ] [ ] [ ] . we postulated that the moral reasoning exercise, which incorporated a number of valuesbased considerations specific to children, would prompt participants to consider their allocative preferences in light of these unique concerns. given the ethical tools to unpack intuitions about what children might deserve relative to adults, we anticipated that participants randomized to the moral reasoning arm would apprehend justifications for preferential allocation to children that may not be immediately apparent. we further hypothesized that participants in the intervention arm would display stronger aggregate preference for children across all the clinical scenarios tested, regardless of the duration of life years gained, as a result of their access to a varied palette of ethical principles by which to justify preferential allocation to children, including vulnerability, dependency, potential, and social distinction. we conducted a population-based stated preference survey of societal views on the prioritization of health resources among children and adults, administered to a non-probability sample of j o u r n a l p r e -p r o o f canadian adults. participants were recruited through letters of invitation emailed to a random sample from a panel of over one million canadians maintained by a survey research firm. a limitation of non-probability sampling is the absence of general statistical theory to predict sample representativeness from survey design assumptions [ ] . to minimize sampling bias and maximize the potential for national population representativeness, we employed interlocking quotas for stratified sampling (age, gender and region), balanced against statistics canada norms, and evaluated the composition of our final sample in comparison to the canadian population on a range of sociodemographic characteristics. the survey was web-based and loyalty program rewards were offered to encourage participation. development of the survey instrument drew on prior literature on the ethics of health resource allocation and social values relevant to child health policy. the principles included in our moral reasoning exercise were derived from a systematic review of the literature on social values relevant to child health and social policy, refined through an in-depth qualitative case study of health technology assessment and policymaking for children in canada [ , ] . iterative refinements to the survey were informed by a pilot phase with experts (n= ) and laypersons (n= ) and field testing with members of the public (n= ). the final survey questionnaire directed respondents to assign numerical preference scores for the allocation of resources in different health care scenarios based on age-related criteria. it presented each participant with the same five hypothetical treatment scenarios (chronic blood disease, liver transplant, cancer therapy, palliative care, and eating disorder); these scenarios were intended to provide variation in disease characteristics such as acuity, morbidity, mortality, potential for cure, and nature of participants chose between funding for treatment among adult (average age ) and child (average age ) patients, from the perspective of a citizen advisor to a health system administrator. preferences were captured as continuous variables on a visual analog scale (vas) from - (full preference for children) to + (full preference for adults), with zero representing neutrality. we employed a vas design to explore changes in the strength of participant preferences for children or adults in order to capture more subtle variation in preference than would have been possible with categorical choices, while still allowing for preference neutrality. demographic data related to age, sex, income, education, employment, health status, and family structure were collected. randomization of participants to either an intervention or control group was achieved via a leastfill approach, employing computational logic to assign respondents to the group with the lowest current quota count, which enabled random assignment with respect to stratification variables (age, gender, region). we subjected participants in the intervention group to a moral reasoning exercise prior to each choice scenario. the exercise presented subjects in the intervention group with a list of twelve ethical principles relevant to allocative decisions ( figure ). we fashioned principles to capture concepts identified as uniquely germane to health resource allocation involving adults and children, including 'fair innings', vulnerability, dependency, future potential, and distinction, as derived from a foregoing systematic review of social values relevant to health and social policy for children [ ] . balance was sought between principles that might inherently favour allocation to either children or adults. participants in the intervention arm were j o u r n a l p r e -p r o o f asked to select the three principles that most influenced their choice in each scenario. subjects in the control arm responded to the choice scenarios without exposure to a moral reasoning exercise. to minimize question order bias, we randomly rotated the order by which health care scenarios were presented to participants; in addition, we randomly rotated the order of principles within the moral reasoning exercise for the intervention cohort. participants were prevented from revising their prior responses as they proceeded through the questionnaire. quantitative survey data were imported into sas (version . ) for analysis. descriptive statistics were employed to characterize the respondent population and compare groups using the student's t-test for continuous variables (age) and chi-squared for categorical variables. we compared select sociodemographic variables from the overall sample with general canadian population demographics from the statistics canada census of population using onesample proportion tests [ ] . we employed a linear mixed-effects random intercept model, which allows for modelling of correlated continuous data, to analyze the strength of participant preferences for each of the scenarios presented and examine the impact of experimental group, scenario, and sociodemographic variables on mean preferences scores, while accounting for the correlation between repeated measures within the same subject. the model examined: ) the difference in mean preference scores by group, scenario, and demographic characteristics and ) the difference in mean preference scores between the intervention and control for each scenario. we analyzed the interaction of group and scenario on preference scores to understand whether group mean preference scores varied by scenario type, controlling for covariates (including age, geographic j o u r n a l p r e -p r o o f region, gender, language, education, employment, income, health, and family structure) (emethods). to further characterize the strength of participant preferences for children or adults, and explore potential choice uncertainty, we analyzed the proportions of respondents displaying any allocative preference beyond the bounds of a 'neutral' construct (zero midpoint), and modelled differences in neutral versus preferential responses as a binary outcome between groups and across scenarios through generalized estimation equation (gee) modelling. odds ratios with % confidence limits were computed to indicate the likelihood of a neutral response for each scenario, using chronic disease as the reference scenario. gee was also used to assess the likelihood of a neutral response by experimental group in each scenario, with moral reasoning as the exposure. lastly, we quantified the proportion of respondents selecting each allocation principle overall and by scenario. we tested equality of proportions across scenarios to detect significant differences in the proportions of respondents selecting a given allocative principle. chi-squared analyses were used to compare the proportions of participants selecting each moral reasoning principle in a given scenario, using one scenario (chronic disease) as a referent. mcmaster university. informed consent was obtained online as part of the survey panel opt-in process prior to individual survey initiation. the authors received no funding related to study design; collection, analysis, and interpretation of data; the writing of the report; or the decision to submit for publication. between april and , , a total of , individuals were screened for inclusion: , were deemed ineligible or declined to participate and , individuals were randomized. of these, we excluded , for incomplete surveys. a total of , ( . %) respondents completed the survey; were subsequently excluded for poor quality (e.g., racing). our final sample included , participants, with in the intervention group and in the control group (efigure ). respondent characteristics were similar across groups (etable ). as compared with canadian population census data, our sample evinced an overrepresentation of individuals with higher educational attainment. we present our results in sequence corresponding to the hypotheses listed above. we begin with an exposition of control group results, to ascertain whether a baseline predilection for allocation to children was apparent in our sample, and how it varied across disease-specific scenarios. we then move to analysis of mean preference scores in the intervention group, and observed differences between the intervention and control group, to isolate the impact of the moral reasoning exercise on participant preferences. our analysis of preference divergence from an age-neutral construct (- . to + . ) follows, to test the strength of allocative preference in either direction. finally, we analyze participant choices about the moral principles guiding their allocative preferences, focusing on the frequency and patterning of principle selection across scenarios. allocative preferences analysis of mean preference scores demonstrated a consistent aggregate preference by control group participants to allocate scarce health system resources to children across all trial scenarios ( figure ; table ). the strongest control group preference for children was observed in the cancer therapy (- . , % ci - . to - . , p< . ) and eating disorders treatment (- . , % ci - . to - . , p< . ) scenarios, in which the theoretical qaly gains were largest. mean scores were statistically significantly higher (more positive) in the intervention group overall, suggesting a weaker preference for allocation to children in those subjected to the moral reasoning exercise (figure ; table ). in the intervention group, a significant preference for allocation to children was retained in the cancer therapy (- . , % ci - . to - . , p< . ) and eating disorder treatment (- . , % ci - . to - . , p< . ) scenarios, but there was no age preference in the chronic disease drug, liver transplant and palliative care scenarios ( table ) . when analyzing the difference in mean preference scores between experimental groups for each scenario, the intervention had the largest absolute impact for the cancer therapy ( . , % ci where the benefits of an intervention were most obvious and different between adults and childrenas they were in respect of life-years gained from cancer and eating disorders therapy -j o u r n a l p r e -p r o o f a choice to prioritize those benefitting most may have seemed easiest, even in the face of exposure to competing moral principles. this explanation is supported by theories of rational decisionmaking from the field of cognitive psychology that posit dual-process thinking, distinguishing intuition from reasoning [ ] [ ] [ ] . the design of our studyincluding the survey format and pacing, question framing, and lay samplemay have induced intuitive responses from some participants, in the face of complex moral problems characterized by inherent uncertainty. in particular, participants may have allowed more obvious differentiators, such as discrepant benefits in length of life, to intuitively shape their preferences, rather than take the time and cognitive effort to work through conflicting moral choices in a rule-bound manner. this is likely particularly true of those unexposed to the moral reasoning intervention, and might explain why preference score differences between the intervention and control groups were largest in respect of cancer therapy and eating disorders treatment. it may also explain why variance in preference scores narrowed consistently across scenarios in the intervention group as compared to the control group: it is possible that this reduction in variance represents a reduction in choice uncertainty, in the context of enhanced participant reliance on analytical reasoning induced by the study intervention. proportions of neutral response (score between - . and + . ) were consistently higher in the intervention group across all scenarios (etable ). univariate gee analysis revealed the impact of the moral reasoning intervention on preference neutrality across children and adults, with neutral responses significantly more likely in the intervention group than the control group we made a conscious attempt to incorporate principles related to an array of individual and societal benefits and costs, to induce reflection on the range of moral reasons one might consider germane to health system resource allocation. we also sought balance between principles that might intrinsically engender preference for children or adults. participants exposed to the moral reasoning exercise demonstrated remarkable consistency in their prioritization of principles for allocative decision-making. the top three principles guiding participants' allocative decisions were: ) treat equally ( . % - . %), ) relieve suffering ( . % - . %), and ) rescue those at risk of dying ( % - . %). in all cases except palliative care, 'treat equally' ranked number j o u r n a l p r e -p r o o f one, with a proportion uniformly greater than %; subjects deemed 'relieve suffering' most important ( . %) in the context of palliative care, followed closely by 'treat equally' ( . %). the least endorsed principles ( %) for assigning allocative preference were: priority to rare diseases, priority to special populations, and priority based on societal productivity. despite consistency in ranking of principles, the proportion of participants selecting a given principle to guide allocative decision-making varied significantly across scenarios ( table ). as compared to the chronic disease treatment scenario, the cancer therapy scenario prompted significantly more participants to cleave to principles that, in theory, justify preferential allocation to children: opportunity to live a full life ( . % vs . %, p< . ), duration of benefit ( . % vs . %, p< . ), and concern for special populations ( . % vs . %, p< . ). they also tended to disavow principles favouring allocation to adults, including family responsibilities ( . % vs . %, p< . ) and economic productivity ( . % vs % p< . ). a similar pattern was observed for the eating disorder treatment scenario, with the addition of vulnerability ( . % vs . %, p< . ) to the principles endorsed. by contrast, in the palliative care scenario, participants displayed significantly more concern for equality of treatment ( . % vs . %, p< . ) and relief of pain and suffering ( . % vs . %, p< . ), and less concern for 'fair innings' (the entitlement to a full lifespan) or duration of benefit. a principal finding of our study is the consistent preference for allocation to children across health care scenarios in the overall cohort. this finding is in keeping with much of the extant evidence on societal preferences for allocation to the young, but adds depth and specificity in preference in response to changes in the duration of benefit from a given intervention [ ] . in the face of life-long benefits (e.g. life-saving interventions), their study participants gave consistent precedence to younger groups when allocating scarce resources. by contrast, when juxtaposed with life-long benefits, fixed benefits induced a preference pattern that privileged young to middle adulthood. our results may indicate similar moral intuitions behind participant choices, though with the notable difference of an equal allocation option. where pure qaly maximization was possiblenamely, in the cancer therapy and eating disorders treatment scenariosparticipants seemed to adjudge the life-long benefits that would accrue to children too large to overlook. conversely, in the scenarios with fixed benefits, preference for allocation to children was weaker in the control group, and a trend toward preference for equal allocation j o u r n a l p r e -p r o o f emerged in the intervention cohort. an alternative explanation could be that participants perceived scenario-specific differences in duration of benefit more readily than other benefits that, though not explicitly mentioned, also retain moral relevance in the context of these and similar scenarios. such benefits could include reduction in inequality of outcomesfor instance, founded on inherent characteristics of the disease (rarity) or population (vulnerability, dependency)or equitable chances to live a full life ('fair innings') [ ] [ ] [ ] [ ] [ ] [ ] . interestingly, our results at once confirm and challenge prior evidence that suggests decision-making from an impersonal vantage point (e.g. a budgetary decision-maker) makes it easier to discriminate in favour of one group as against another. nord et al. elicited allocative preferences from study participants within two different assumed perspectives: a 'veil of ignorance', in which the participants themselves might need the health intervention in question one day; and a health system administrator role, in which they were tasked with decisions about resource allocation to others from a budgetary standpoint [ ] . they found that the tendency to privilege younger people in allocative decisions was more evident amongst those who assumed the latter perspective, and argued that the degree of emotional remove induced by the shift in perspective might account for this difference. evidence from our study for the moderating effect of a moral reasoning exercise on participant preferences for allocation to children, from an administrative perspective, suggests the opportunity for ethical reflection mitigated participant willingness to discriminate between groups on the basis of age. this may reflect choice uncertainty and a resultant instinct for preference neutrality, rather than evidence of real, rich moral deliberation. alternatively, this may represent a 'depersonalizing' effect of moral deliberation on allocative decision-making, one sufficient to impact societal preferences for health resource allocationbut in the opposite direction to that observed by nord et al. counter to our hypothesis, exposure to a moral reasoning intervention diminished participant preferences for allocation to children. evidence of a moderating effect of moral reasoning on allocative preference for children suggests the opportunity for ethical reflection mitigated participant willingness to discriminate between groups on the basis of age. this relationship may have been driven by a more varied set of ethical principles with which to draw conclusions. interestingly, this is the same consideration that motivated our hypothesis of increased preference for children through moral reasoning. we presumed that the ethical nuances attached to funding health interventions for childrenincluding distinguishing features such as vulnerability, dependency, neglect, and future potential, that stood out in prior normative analyses of child health and social policywould come through more clearly to participants when exposed to a range of principles touching on them [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . notably, the strength of preference for equal allocation increased among those randomized to the moral reasoning exercise. one interpretation of this is that the intervention prompted participants to evaluate the relationship between their moral intuitions and their stated preferences, and induced a reasoned judgment about the importance of equality as a guiding principle for resource allocation. an alternative explanation is that, despite the study intervention, it remained cognitively difficult for participants to reason through the uncertainty inherent in weighing competing moral principles. the greater predilection for neutrality in the experimental group may have represented retreat to equality in the face of difficult choices. our study admits of potential limitations. in relation to the survey instrument, the brief statements used to evoke the meaning of each principle may have failed to capture its ethical nuances. different framing of the principles may have led to different patterns of preference among participants; however, randomly varying the sequence of principles mitigated any ordering effect bias [ , ] . use of a continuous scale overlapping zero to measure the strength of allocative preferences in the context of a binary choice task (fund either intervention a or b) may have led some participants to misinterpret zero as a choice to allocate equal sums of money to each population, rather than agnosticism about which intervention to fund. we sought to mitigate this potential limitation through simple, explicit scenario instructions; however, it is possible that misapprehension of the 'neutrality of preference' state by some participants impacted our results. the study was not designed to measure the time it took to read the principles in the moral reasoning intervention separately from completing the choice tasks. this could have given a proxy sense of whether participants read and engaged with the ethical ideas and choices involved. the assembly and composition of our study sample may have also limited the external validity of our results. values endorsed by the canadian public may not reflect those of other polities. the use of covariate-adaptive randomization to form balanced treatment groups with respect to relevant covariates has both benefits and inherent shortcomings; use of stratified randomization may have permitted some selection bias and only balanced a limited number of potentially relevant covariates [ ] . more specifically, the survey firm generated cohorts from an opt-in panel of eligible canadians recruited and incentivized through brand loyalty points programs. some of the inherent selection bias associated with online opt-in panels was evident, privileging those with higher education who are web literate. however, the lack of statistically significant impacts of education and income on preference scores in the multivariate model attenuates theoretical concerns about sociodemographic bias. our study also has important strengths. it is, to our knowledge, the first to experimentally examine the values behind health and social policy decisions about children, their valence in relation to adult needs and priorities, and their stability in the face of moral deliberation. its randomized design and large, heterogeneous population-based sample allowed for robust conclusions about the effect of the intervention on participant preferences. our findings demonstrate a convincing relationship between exposure to a range of relevant moral principles and the priorities set. this affirms the complexity of such decisions and the impact of ethical deliberation on them. these findings challenge reflexive trust in survey-based preference elicitation, and imply the need to complement such modalities with deliberative modes of public engagement on questions of social importance, such as the allocation of scarce public resources. in policy terms, our work both supports and challenges conceptions of value in health care based primarily on qaly maximization. dominant modes of health economic evaluation privilege interventions that maximize aggregate individual and societal utility, typically in the form of the duration and magnitude of benefits reaped and the size of the population reached. our results demonstrate a stronger preference for children in the hypothetical scenarios (cancer and eating disorders) in which the duration of benefit accrued mainly to children; this may represent an underlying motivation by participants to maximize benefits. however, we also observed a strong inclination for equality and humanitarianism amongst study participants, regardless of experimental group. the three principles deemed most salient to priority-setting were equal treatment, relief of suffering, and rule of rescue. none of these prioritizes age as a relevant variable; each starts from a belief in the intrinsic value of all human life, and resists grading that j o u r n a l p r e -p r o o f value by social context or circumstance. our results, therefore, suggest the need to incorporate other values into health care priority-setting, as some value frameworks for funding decisions have begun to do [ ] . the salience of these findings to priority-setting efforts in the context of public health emergenciesincluding access to scarce ventilators or drugs in the context of the covid- pandemicis readily apparent. they furnish empirical evidence for the adjudication and refinement of ethical frameworks for triage and resource allocation during the pandemic based on public values in canada [ , ] . efforts to incorporate a broader range of public values and preferences in health and social policy decisions also involve inherent risks. among them is the need to confront and grapple with public attitudes that conflict with the fundamental normative or legal principles that structure most democratic societies, including basic commitments to the protection of individual rights and nondiscrimination [ ] . future research to explore this tension and ways to resolve or address it is warranted. allied to this, our study affirms the importance of process in health care priority-setting exercises. the opportunity to explicitly consider varied normative ideas appears crucial to informed allocative decisions based on public values. the observed changes in public preferences in the face of competing moral principles imply the impact, and potential relevance, of structured opportunities for moral reasoning when making such consequential decisions. this includes the potential value of deliberative public engagement to health policymaking, particularly in domains where distinct ideas about the public good may compete. specific to children, few efforts to incorporate public deliberation in research and policy on child health and social policy priorities have prevailed to date. in the face of resource scarcity, evidence-informed child health and social policies will depend on the careful elicitation and integration of public values. this and allied work bear potential relevance in social policy domains beyond health, including public attitudes to j o u r n a l p r e -p r o o f 'deservingness' attached to welfare state distributional policies in domains as diverse as labour markets and education [ ] [ ] [ ] [ ] [ ] [ ] [ ] . crucial future areas of inquiry and application include the inclusion of child voices in research and policymaking, and the exploration of social values for priority setting within public policies and programs for children. our study underscores the relevance of age in public preferences for the allocation of scarce health care resources, extending evidence of this calculus to trade-offs involving children. nevertheless, it demonstrates the mutability of such preferences in the face of structured moral deliberation. this finding has three main repercussions. it furnishes a critical lens for the interpretation of stated preference surveys; introduces a note of caution into dominant modes of health care funding allocation decisions premised on utility maximization; and implies the value of deliberative methods as a complement to both. we observed a strong inclination for equality and humanitarianism amongst study participants, regardless of experimental group. these moral impulses prevailed over consequentialist logic, including priority to the young founded on aggregate benefit. the stability of these principles in the face of changing allocative preferences signals their importance as public valuesbut it also hints at the complexity of values-based decision-making. the public seems, at face value, to believe in equality of access and defend a set of shared human entitlements to care. it also seems to assign intuitive priority to children. the challenge of reconciling these convictions demands processes nimble enough to negotiate this paradox. spaces for moral deliberationwhether in large-scale surveys or focused qualitative engagementare essential to arrive at health care priorities that reflect what we collectively hold dear. j o u r n a l p r e -p r o o f contributions: ad conceived and designed the study. sc and ad performed the statistical analysis. ad prepared the first draft of the manuscript. all authors contributed to study design, critically revised the manuscript, and approved the final version. as corresponding author, ad accepts responsibility for the work, had full access to the data, and controlled the decision to publish. ad attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. acknowledgements: during the period of this research, ad was supported by grants from the canadian institutes of health research, pierre elliott trudeau foundation, canadian child health clinician scientist program, and pediatric oncology group of ontario. imagine that two different medicines are available to manage an incurable chronic blood disease: one drug treats the child form of the disease, while a different drug treats the adult form of the disease. without treatment, patients die of the disease within months of diagnosis. with drug treatment, both child and adult patients can be expected to live about years from diagnosis, after which they usually die from progressive complications of the disease. each drug costs the same amount of money and would serve the same number of people. the health system can only afford to fund one of the two drugs at present, and cannot split the money between the two drugs. please slide the bar to any point on the scale from - to + to show your strength of support for funding one of the drugs. a drug is available for patients with childonset blood disease. a drug is available for patients with adultonset blood disease. patients live about years with the treatment, at which point they usually die of complications from the disease. without the drug, the disease causes death within months. without the drug, the disease causes death within months. fund treatment based on evidence that it works  "fund treatments best proven to be safe and effective."  "since it is harder to study treatments in children, evidence is usually stronger for adult treatments."  "the older patients have had their turn."  "give the younger patients a chance for a full life." treat people who will benefit longer  "giving the treatment to the younger group makes sense, since they will enjoy it longer."  "lifelong potential should be factored into decisions about which health interventions to fund."  "at , people may be raising families or have others who rely on them."  "resources should be directed to help those that cannot protect or advocate for themselves."  "children are still developing, so can suffer lifelong consequences from untreated disease." treat people who are productive  "helping people who are in the workforce has benefits for all." treat everyone equally  "all patients deserve equal access to medical care."  "both groups should have the same chance." treat those who are dependent on others  "children are dependent on their parents or caregivers, so their illness has direct impacts on the lives of others." r : the full model with predictors explained . % of within-subjects variance and . % of between-subjects variance, as compared with the null model (without predictors). comparing the full model with a parsimonious model (non-significant predictors removed), the two models were almost identical. the parsimonious model explained . % more of the between-subjects variance; there was no difference in within-subjects variance explained. details omitted for double-blind reviewing making the case for value-based payment reform in children's health care details omitted for double-blind reviewing health technology funding decisionmaking processes around the world: the same, yet different details omitted for double-blind reviewing effect of discussion and deliberation on the public's views of priority setting in health care: focus group study details omitted for double-blind reviewing democracy and deliberation considered opinions: deliberative polling in britain can a moral reasoning exercise improve response quality to surveys of healthcare priorities which of two individuals do you treat when only their ages are different and you can't treat both the utility of health at different stages in life: a quantitative approach is the valuation of a qaly gained independent of age? some empirical evidence an empirical study of the fairness of allocation of health care resources the significance of age and duration of effect in social evaluation of health care measuring people's preferences regarding ageism in health: some methodological issues and some fresh evidence utilities versus rights to publicly provided goods: arguments and evidence from health care rationing ethical and distributive considerations measurement of health state utilities for economic appraisal the social value of a qaly: raising the bar or barring the raise? qalys and ethics: a health economist's perspective qaly maximisation and people's preferences: a methodological review of the literature consequentialism and its critics rights, goals, and fairness development as freedom personal utilities and public judgements: or, what's wrong with welfare economics rational normative economics vs 'social welfare' and 'social choice the social value of health programmes: is age a relevant factor? preferences for lives, injuries, and age: a stated preference survey are some lives more valuable? an ethical preferences approach maximizing health benefits versus egalitarianism: an australian survey of health issues preferences for life saving programs: how the public discounts time and age health priorities and public preferences: the relative importance of past health experience and future health prospects the nature of procedural preferences for health-care rationing decisions should health gains by children be given the same value as health gains by adults in an economic evaluation framework? in: economic evaluation in child health details omitted for double-blind reviewing details omitted for double-blind reviewing details omitted for double-blind reviewing details omitted for double-blind reviewing the generation gap: differences between children and adults pertinent to economic evaluations of health interventions are newborns morally different from older children? social policy for children and families: a risk and resilience perspective life course health development: an integrated framework for developing health, policy, and research towards a sociology of child health details omitted for double-blind reviewing details omitted for double-blind reviewing a review of conceptual approaches and empirical evidence on probability and nonprobability sample survey research a perspective on judgment and choice -mapping bounded rationality individual differences in reasoning: implications for the rationality debate? who is rational? studies of individual differences in reasoning intergenerational equity: an exploration of the 'fair innings' argument an equity framework for health technology assessments voices for children: rhetoric and public policy values and assumptions underpinning policy for children and young people in england an evaluation framework for funding drugs for rare diseases age-related preferences and age weighting health benefits eliciting preferences for prioritizing treatment of rare diseases: the role of opportunity costs and framing effects psychology and economics a better alterative to stratified permuted block design for subject randomization in clinical trials details omitted for double-blind reviewing a framework for rationing ventilators and critical care beds during the covid- pandemic fair allocation of scarce medical resources in the time of covid- details omitted for double-blind reviewing who should get what, and why? on deservingness criteria and the conditionality of solidarity among the public the deservingness heuristic and the politics of health care the political logic of labour market reforms and popular images of target groups public support for sanctioning older unemployed-a survey experiment in european countries the need for and the societal legitimacy of social investments in children and their families: critical reflections on the dutch case the role of welfare state principles and generosity in social policy programmes for public health: an international comparative study contemporary public policy influencing children and families  "when it comes to relieving suffering, other factors shouldn't count."  "we should always relieve pain when we can."we should rescue those at risk of dying  "everyone deserves the same chance of rescue from life-threatening circumstances."  "saving someone's life is important, regardless of age."treat those society considers special  "children are a distinctly valued social group that deserves privileged treatment."give priority to rare diseases  "rare diseases are often neglected, so should receive special priority."  "childhood disease are often rarer than adult ones, so might be unfairly overlooked in health system planning." key: cord- -d iu authors: manrique de lara, amaranta; de jesús medina arellano, maría title: the covid- pandemic and ethics in mexico through a gender lens date: - - journal: j bioeth inq doi: . /s - - - sha: doc_id: cord_uid: d iu in mexico, significant ethical and social issues have been raised by the covid- pandemic. some of the most pressing issues are the extent of restrictive measures, the reciprocal duties to healthcare workers, the allocation of scarce resources, and the need for research. while policy and ethical frameworks are being developed to face these problems, the gender perspective has been largely overlooked in most of the issues at stake. domestic violence is the most prevalent form of violence against women, which can be exacerbated during a pandemic: stress and economic uncertainty are triggers for abuse, and confinement limits access to support networks. confinement also exacerbates the unfair distribution of unpaid labor, which is disproportionately assigned to women and girls, and highlights inequality in the overall labor market. lack of security measures has resulted in attacks towards health workers, particularly female nurses, due to fear of contamination. finally, resource results in lack of access to other health necessities, including sexual and reproductive health services. research across all disciplines to face—and to learn from—this crisis should be done through a gender lens, because understanding the realities of women is essential to understand the pandemic’s true effects in mexico and the world. this year's international women's day was a historic occurrence in mexico (el universal ). tens of thousands of women took to the streets on the eighth of march and then chose to vanish on the ninth (averbuch ) . each day in its own way, the socalled m and m were meant to raise awareness about femicides and the foundation of structural violence against women on which they stand. women all across the country sought to generate a widespread debate and called for active commitment from key stakeholders and decision-makers. but while they marched through the streets in mexico, the rest of the world was beginning to become paralyzed by a virus which has claimed over , lives globally, confining individuals and families to their homes, and overwhelming already fragile health systems (world health organization ). and in this unprecedented situation, girls and women in mexico find themselves caught between a rock and a hard place of two public health crises-the pandemic and gender-based violence-in a country where misogyny seems part of our cultural heritage (htun and jensenius forthcoming) . in the mexican context, structural violence against women is normalized and spans every sphere of society. even the written press has played a role in this normalization, particularly through femicide coverage (tiscareño-garcía and miranda-villanueva ). that is why a gender perspective should be included when analyzing issues, to find solutions that do not exacerbate inequality. during this pandemic, a lot of significant ethical and social issues have been raised, such as: the extent of restrictive measures, the reciprocal duties to healthcare workers, the allocation of scarce resources, and the need for research (palacios-gonzález ). while policy and ethical frameworks are being developed to face these problems, here we will try to show how the gender perspective has been largely overlooked in practice during the pandemic response in mexico. understanding the realities of women is essential to understand the true effects of this pandemic. similarly, we believe including feminist approaches to the many ethical and social issues would allow decision-makers in mexico to reach more optimal solutions. this is because traditional approaches tend to be abstract and based on universal absolutes, which ignore the diverse realities of women's experiences. further, these absolutes tend to focus on individualistic principles like autonomy, ignoring other ethical principles like solidarity, compassion, and communitarian values which are essential (medina-arellano ). indeed, solidarity has been made a cornerstone of the global pandemic response, but how this principle is translated to practice both internationally and within our borders necessitates the recognition of power dynamics, including the prevalence of gender inequality. the first topic of discussion is the deployment of restrictive public health measures. social distancing measures, such as shelter-in-place orders, have become essential to counteract the rapid spread of sars-cov- . however, besides seeming incompatible with the socioeconomic reality in mexico where many people live day-to-day (padrón innamorato, gandini, and navarrete ), isolation and confinement at home are extremely concerning for women's safety. in our country, domestic violence is the most prevalent form of violence against women, also impacting the lives of children (scolese et al. ) . further, a considerable number of femicides is perpetuated in family, couple, or friendship environments (lara olmos ). in fact, the rate of femicides has increased by . per cent in the period of january to june compared to (urrutia and jiménez ) . as the data shows, athome violence and violence against women in general can be exacerbated during a pandemic: stress and economic uncertainty are triggers for abuse, and confinement pulls women away from their existing support networks or makes it difficult for them to find new ones. ideally, public programmes would have been set in place to respond to these issues before the general population was asked to stay at home. there are indeed existing programmes, like hotlines for gender violence. however, we need to realize that those measures are not sufficient in the current context and ask questions like: how can i call for help if there is constant forced coexistence with my aggressor? where should i go to find shelter without being exposed to contagion? how can i file a lawsuit, or follow-up on one, while staying at home? who ensures that i can have access to justice when the government workforce is not at full capacity? developing mobile applications to serve as panic buttons could be an effective solution (ministerio de las mujeres & géneros y diversidad ). importantly, access to mental health support should be fully guaranteed, since suicide rates, especially among married women, are intricately linked to conflict within the household (beleche ). however, we must always remember that violence against women is an intersectional issue. for example, socioeconomic status is a contributing factor to domestic violence, and the women who need the most help might be the same women who have less access to technology; the same is true for other marginalized women, such as indigenous or racialized women. therefore, to be effective, these tools must be part of more widespread, cohesive policy efforts, relying on interinstitutional cooperation among relevant agencies. another consequence of confinement is that it highlights the existing inequality, based on misogynistic stereotypes, in the distribution of unpaid labor (i.e. household chores and care) (salgado-galicia et al. ). this inequality was normalized when authorities stated that women at home would have no issue looking after the health of elders, affirming that men tend to be "more detached" (morales, miranda, and villa y caña ). during quarantine, most women will be responsible for: increased household chores; caring for children, including aid in schoolwork and education due to schools closing down; tending to family members with any physical or mental disability; caring for the elderly; and, in some cases, looking after family sick with covid- . importantly, we should also be thinking about how the unequal distribution of domestic chores will affect young girls and teenagers during confinement (wang et al. ) . it is likely that having to do school from home will force them to put their education aside, since they will be expected to help with chores or care for their siblings, for example. girls have less access to education and less academic opportunities than boys as it is, and we need to start thinking about ways to avoid this reality being exacerbated in our country post-pandemic. in that sense, we think it is also important that more women who work in the pandemic relief are showcased, especially those in top positions, to serve as role models. it is sadly unsurprising, but very illustrative of the inequality in our country, that most of the spearheads giving press conferences and shown on media are male, partly explained by the persistence of male directors and executives at the national institutes of health in mexico (rivera-romano et al. ). on top of the difficult situation at home, a lot of women will also take on professional responsibilities. this is made harder in a labour market where already they deal with increased job insecurity-including lack of access to health insurance-and lower salaries. these situations once again highlight the importance of an intersectional perspective, since indigenous women and women living in poverty are disproportionally affected; for example, those who participate in paid but exploitative domestic labor (rojas-garcía and toledo gonzáles ). regarding healthcare workers, an important ethical issue is the scope and limitations of their duties during the pandemic. they will unavoidably face increased risk of contracting covid- , but this is only acceptable when there are reciprocal obligations from the state. this includes providing sufficient resources like face masks and other protective gear, including strategies to prevent burnout syndrome which is more prevalent on female medical students (miranda-ackerman et al. ). broader security measures should also be provided, since healthcare workers, particularly female nurses, have sadly been attacked for fear of contamination. it must be stressed that women make up most of the healthcare workforce at the frontlines (world health organization ); therefore, governments, should ensure access to care facilities and school aids for their children, as well as services to aid in the care of any other dependents. similarly, even though it is expected that the health system will be overwhelmed, female health workers who are in special situations, such as maternity leave or those who are breastfeeding, should not be, under any circumstance, expected to risk exposure and should not face any penalties. finally, the public debate should avoid using hierarchical language based on sexist stereotypes when speaking about the healthcare workforce-médicos (male doctors) and enfermeras (female nurses)-which contributes to existing power dynamics. another ethical issue relates to the distribution of scarce resources. the fair allocation of ventilators is a particularly hot topic at this time, and the ethical framework developed in mexico appropriately included a gender perspective (guía bioética ). however, medical resources and health staff being diverted to face the crisis will also affect health beyond covid- . this issue has been internationally recognized by the release of a joint statement regarding the protection of sexual and reproductive health and rights of women during the pandemic response (klasing ) . while mexico signed said statement, there is still more work to be done in practice. the concern arises partly because rates of obstetric violence in mexico are already high (calvo aguilar, torres falcón, and valdez santiago ), and it took some time to issue a special protocol regarding access to healthcare for pregnant women before, during, and after childbirth to prevent covid- infection (secretaría de salud ). another concern emerges from the lack of access to family planning and contraception methods. in particular, access to emergency health services for victims of sexual violence, such as safe means to interrupt a pregnancy resulting from rape, which is a recognized right in all of mexico (nom- -ssa - ) . the provision of abortion services must be ensured in a timely manner, given that these procedures cannot be postponed and should be considered urgent, especially when they are legally recognized rights. indeed, in addition to the rape causal nationwide (nom- -ssa - ; ministry of health, mexico ), the decision to interrupt a pregnancy on any grounds has been recently decriminalized in the state of oaxaca, and abortion services are constitutionally guaranteed for any reason by the public health system in mexico city. beyond any moral opposition to abortion, these services are at risk of being set aside because they are sometimes thought to only pertain to women, and women's interests are considered secondary. women's right to health is linked to their rights to life, free development of personality, human dignity, and sexual and reproductive freedom. all of these constitute undisputed human rights which cannot be discarded by any measure of exceptionality, even in the face of scarcity in the health sector. women's independence is inextricably linked to control over their bodies and reproduction, and any argument to justify taking away that right is undeniably a form of discrimination against women, especially towards women already marginalized in mexico due to racism and classism. one final issue raised by the pandemic is the need for research. we affirm that focused research must be done with a gender perspective. this includes: biomedical research about any differential responses to treatment; public health research to look at the effects of resource deviation on women's physical health and of confinement on women's mental health; economic research to look at the impact on the female informal workforce; and social research to see whether more girls are made to drop out of school and how rates of violence respond to social distancing. these approaches to research will prove invaluable not only to face this pandemic but to have reallife data in place to inform decision-makers in the future. among everything that has happened, this pandemic has managed to highlight and exacerbate the existing inequalities and flaws in our social structure (papp and hersh ) . even though the th of march and the women's march seem like another lifetime, the demands remain current. the topics we have discussed about women's access to health, justice, and a life free of violence must be fundamental issues in any and every plan to face this pandemic. yes, we are all worried about the pandemic and what is to come, but we must remember that the structural violence women face every day remains itself an unattended public health crisis. indeed, while social distancing to reduce transmission, women are stuck at home with their aggressors. while the health system struggles to provide life-sustaining services, eleven women are still dying every day in this country just for being women (xantomila ) . the government must not consider this a secondary issue, because women in mexico sure do not have the option of forgetting. acknowledgements this work was supported by unam-papiit ig . open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creativecommons. org/licenses/by/ . /. we'll disappear': thousands of mexican women strike to protest femicide. the guardian domestic violence laws and suicide in mexico obstetric violence criminalised in mexico: a comparative analysis of hospital complaints filed with the medical arbitration commission women's day : thousands of women took over mexico to demand justice and equality through massive protests aspirational laws as weak 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national institutes of health paid domestic work: gender and the informal economy in mexico the role of socioeconomic status in the susceptibility to develop systemic lupus erythematosus in mexican patients intimate partner violence against low-income women in mexico city and associations with child school attendance: a latent class analysis using cross-sectional data lineamiento para la prevención y mitigación de covid- en la atención del embarazo, parto, puerperio y de la persona recién nacida victims and perpetrators of feminicide in the language of the mexican written press crecen feminicidios en lo que va del año, reporta durazo. la jornada mitigate the effects of home confinement on children during the covid- outbreak delivered by women, led by men: a gender and equity analysis of the global health and social workforce coronavirus (covid- ). last modified onudh: en méxico se cometen en promedio . feminicidios al día publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -yt k m authors: han, rachel h.; schmidt, morgan n.; waits, wendi m.; bell, alexa k. c.; miller, tashina l. title: planning for mental health needs during covid- date: - - journal: curr psychiatry rep doi: . /s - - - sha: doc_id: cord_uid: yt k m purpose of review: the ability to effectively prepare for and respond to the psychological fallout from large-scale disasters is a core competency of military mental health providers, as well as civilian emergency response teams. disaster planning should be situation specific and data driven; vague, broad-spectrum planning can contribute to unprepared mental health teams and underserved patient populations. herein, we review data on mental health sequelae from the twenty-first century pandemics, including sars-cov (covid- ), and offer explanations for observed trends, insights regarding anticipated needs, and recommendations for preliminary planning on how to best allocate limited mental health resources. recent findings: anxiety and distress, often attributed to isolation, were the most prominent mental health complaints during previous pandemics and with covid- . additionally, post-traumatic stress was surprisingly common and possibly more enduring than depression, insomnia, and alcohol misuse. predictions regarding covid- ’s economic impact suggest that depression and suicide rates may increase over time. summary: available data suggest that the mental health sequelae of covid- will mirror those of previous pandemics. clinicians and mental health leaders should focus planning efforts on the negative effects of isolation, particularly anxiety and distress, as well as post-traumatic stress symptoms. although the coronavirus (covid- ) pandemic initially resulted in roughly new covid- -related listings each week on the pubmed.gov website, very few of these publications addressed the practical matter of how mental health providers and leaders should specifically plan for the post-pandemic mental health tsunami that many predict is inevitable [ ] . the purpose of this article, written from the perspective of military medical planners, is to present available data on the prevalence of specific mental health concerns and conditions from previous recent pandemics and covid- , as well as to provide data-informed recommendations for meeting the psychological needs of affected individuals. historically, pandemics have had significant ramifications for psychological stress and mental health. the global reach and protracted course are unique to pandemics and other infectious disease outbreaks compared with other types of disasters. prolonged social distancing protocols, increased unemployment rates, and economic stress have the potential to create an unprecedented mental health crisis. from prior disasters, military researchers have learned that affected people tend to do well over time with minimal psychiatric sequelae [ ••]. however, there is still concern for residual psychopathology, including anxiety, depression, bereavement, and posttraumatic stress. among healthcare workers (hcws) in particular, decreased social support and isolation may be expected even while at work due to assignment to unfamiliar hospital areas, requirement for personal protective equipment (ppe) that obscures identities, and inability to gather in groups [ physical distancing, while important to protect against physical illness, often results in social isolation and loneliness, especially for vulnerable groups. it is well known that social isolation has a detrimental effect on mental health outcomes. both living alone and feelings of loneliness have been associated with increased suicidal ideation and suicide attempt [ ] . further, since covid- was declared a public health emergency, many employees have been either laid off or furloughed, causing economic anxiety and distress. many schools and daycares have also physically closed indefinitely, forcing families with children to take time off from work to provide childcare and take on the additional burden of assisting with virtual learning. in the past, times of economic downturn have been associated with increased rates of completed suicide in high-income countries [ ] . accordingly, we anticipate a rise in mental healthcare usage and increased susceptibility of certain groups to mental illness and its consequences as the pandemic continues. we conducted a rapid review of the twenty-first-century pandemics with the goal of establishing a preliminary projection of mental health needs related to covid- . since formal preferred reporting items for systematic reviews and meta-analyses (prisma) guidance for rapid reviews is currently pending, we referred to a published analysis of the most common rapid review elements while conducting our review [ ] [ ] [ ] . questions we hoped to answer included the following: what mental health sequelae emerged following pre-covid- twenty-first-century pandemics? and what does preliminary data on the psychological effects of covid- reveal? our rapid review included papers published from january to july on pubmed, as well as searches of various gray literature sources for guidelines, position papers, and journalistic reports. search strategies were structured around three major concepts: pandemics, mental health, and data analysis. a combination of the following keywords in the title and/or abstract was used in searches of literature on the southeast asian respiratory syndrome (sars), h n influenza (h n ), middle eastern respiratory syndrome (mers), ebola, and covid- pandemics: mental health or mental illness or psychiatry or psychology or therapist or ptsd or posttraumatic or post-traumatic stress disorder or behavioral health or anxiety [disorder] or gad or depression/depressed or complex grief and data analysis or statistic* or prevalence or percentage or increase or decrease. peer-reviewed articles addressing the mental health sequelae during or following the listed pandemics were included. other inclusion criteria were populations of all age groups, from any location, and published in english. articles that reported physical health rather than mental health were excluded. articles that reported on preventative behaviors were also excluded. additional exclusion criteria included case studies, abstracts, commentaries, and opinion pieces. titles and abstracts of the identified literature were first reviewed. literature not complying with the search criteria was excluded. the full text was obtained for articles in which inclusion/exclusion criteria were not clear, and references were independently screened. the findings presented chronologically below are based on information pertaining to recent pandemics, including severe acute respiratory syndrome (sars), h n influenza virus (h n ), middle eastern respiratory syndrome (mers), ebola, as well as the current covid- pandemic (see fig. ). findings for children pertaining to covid- are discussed separately given the unique psychological conditions considered for this population. the sars coronavirus epidemic spread through countries in , resulting in over cases, largely affecting asian countries. community-based surveys revealed that during the outbreak, almost % of community populations experienced increased stress, with % experiencing post-traumatic stress symptoms [ ] . a taiwan-based study showed . % of a nationwide sample had a psychiatric morbidity measured by the brief symptoms rating scale [ ] . hcws were also significantly affected due to risk of exposure, with higher ratings of stress and depressive and anxious symptoms persisting a year post-outbreak [ ] . six percent self-medicated with alcohol to cope with these feelings [ ] . having to quarantine also caused a significant increase in depressive symptoms [ ] . nonetheless, no rise in dsm-iv psychiatric diagnosis was found years later [ ] . elderly populations appeared to be at greater risk of suicide, with a % increase in completed suicides among adults aged and older in hong kong in at the peak of sars cases. further analysis led to identification of certain factors, including fear of contracting sars, increased isolation, disruption of social life, and increased chronic disease burden [ ] . finally, survivors had significant levels of psychiatric morbidity after the epidemic. prevalence of any psychiatric disorder at long-term follow-up was - . %, with % of survivors carrying a diagnosis of post-traumatic stress disorder (ptsd) and % having a depressive disorder [ , ] . in the usa, the h n influenza virus was first detected in april . by april , the centers for disease control and prevention (cdc) estimated about . million cases, , hospitalizations, and , deaths due to the virus in the usa alone. the published data on behavioral/ psychological responses focuses mostly on the anxiety prevalent due to uncertain conditions among hcws [ ] . in guangzhou, china, . % of university students reported feeling panicked, depressed, or emotionally disturbed as a result of h n , and % worried about them or their family catching the virus [ ] . hcws in greece experienced moderately high anxiety about the pandemic, with their predominate concern being infection of family and friends and subsequent health consequences. interestingly, perceived sufficiency of public information about h n was associated with reduced degree of worry [ ] . this finding was consistent with findings among hcws in japan, where workers who were less frequently provided information about the pandemic felt less protected than their more informed colleagues. in addition, fig. flow diagram for review of pandemic mental health outcomes japanese hospital workers in higher risk environments felt more anxious and exhausted [ ] . the middle east respiratory syndrome (mers) first emerged in saudi arabia in and spread throughout the arabian peninsula, affecting over individuals. while person-to-person transmission was limited, hcws were deemed to be at higher risk for contracting mers, with a case fatality rate of around - %. a south korean study of quarantined individuals showed . % had feelings of anxiety during quarantine, but only % had persistent anxiety at - months after release. risk factors for anxiety included inadequate supplies, somatic symptoms related to mers, financial loss, social media use, and a history of psychiatric illness [ ] . the - ebola outbreak in west africa spread rapidly due to inadequate healthcare facilities, lack of trained staff, and poor health literacy, leading to inability to receive care from hcws who were often exposed to and contracted the disease. one year after onset in sierra leone, a study on the mental health impact on the general population revealed a prevalence of almost % of any anxiety or depression symptoms via patient health questionnaire- (phq- ). prevalence of any ptsd symptom was %, as measured by six items from the impact of events scale revised. of note, only % met the clinical cut-off for anxiety and depression. for ptsd, % met levels of clinical concern, and % met probable diagnosis. factors associated with higher reporting of symptoms included region of residence, experiences with ebola such as knowing someone quarantined, and perceived threat [ ] . the outbreak reached spain, the uk, and the usa as a result of globalization and international travel, threatening global security and the world economy. in late , the us military sent troops to west africa to help curb this epidemic. a review examining the potential psychological impact of this deployment qualitatively predicted that deployed service members would return with clinically significant problems, including psychological distress, alcohol/drug use, post-traumatic stress disorder, anxiety, and most significantly depression. they also suggested that among militaryspecific sociodemographic factors (young, single, no family, less work experience, lower educational levels and income) predicted poorer outcomes [ ] . the second deadliest ebola outbreak was in and is currently ongoing. as a result, in the democratic republic of the congo, mental health professionals have joined response teams to provide psychological treatments to patients dealing with anxiety and death [ ] . a systematic review of the prevalence of mental health problems in populations affected by the outbreak revealed that approximately % of individuals exposed to the virus (survivors, families, communities, healthcare workers, safe and dignified burial teams) were diagnosed with depression [ ] . on may , , the united nations (un) policy brief on "covid- and the need for action on mental health" noted concerns over widespread psychological distress, referencing three sources [ ] . the first was a study in china claiming to be the first nationwide large-scale survey of psychological distress in the general population. in total, , responses to a self-reported questionnaire sought to identify demographic characteristics associated with higher distress levels. the authors suggested that the country's response to the covid- pandemic, including implementation of strict quarantine measures, triggered a wide variety of psychological problems, such as panic disorder, anxiety, and depression [ •] . the second was a study in iran that used the same survey as above. based on responses, the authors concluded that predictors of distress may vary across countries, citing differences in age and education that predicted distress in china but not in iran (younger age and higher education correlated with higher distress in china) [ •] . the third was a survey from april by the kaiser family foundation revealing that % of adults in the usa believed the pandemic had affected their mental health. of note, % reported increasing alcohol or drug use. sixtyfour percent of those who reported stress and worry around covid- come from front-line hcws and their families and % from americans who experienced an income loss [ ] . as recently as late june, % of us adults reported struggling with mental health issues or substance use, with % endorsing anxiety/depressive symptoms, % endorsing traumarelated symptoms, % endorsing starting or increasing substance use, and % seriously considering suicide [ ••] . in china, the immediate psychological effects of the covid- outbreak were more specifically studied in the general population. using the impact of event scale-revised (ies-r), . % reported moderate or severe psychological impact. using the depression, anxiety and stress scale (dass- ), . % had moderate to severe anxiety symptoms, . % had moderate to severe depressive symptoms, and . % had moderate to severe stress levels. notably, specific physical symptoms such as myalgia, dizziness, coryza, and poor self-rated health status were significantly associated with a greater psychological impact of the outbreak and higher levels of stress, anxiety, and depression [ •] . another similar study in the general population on generalized anxiety disorder (gad) symptoms, depressive symptoms, and sleep quality revealed similar findings. results showed that the overall prevalence of anxiety symptoms (using generalized anxiety disorder -item score > ) was . %, depressive symptoms . %, and poor sleep quality . %. of note, they also found that hcws were more likely to have poor sleep quality than the general population [ results from previous pandemics were limited and did not explore the effect of quarantine on children and families. however, initial data from the covid- pandemic has shown a detrimental effect of quarantine on children. a survey of primary school students (grades - ) in the hubei province of china during lockdown measures found that . % reported depressive symptoms and . % reported anxiety [ •] . in shanghai, parents of children with attention-deficit/hyperactivity disorder (adhd) aged - reported that their behaviors were significantly worse during lockdown [ •]. among chinese students aged - , prevalence of depressive and anxiety symptoms were . % and . %, respectively, with risk factors including female gender, higher grade level, and lower self-assessed knowledge of covid- [ • ]. published data regarding mental health sequelae from recent pre-covid- pandemics is limited. most studies have used broad-sweeping inventories of distress and psychological symptoms instead of specific diagnostic screening instruments. very few prospective clinical trials appear to have been published, and the few reasonably well-constructed retrospective trials had relatively small study populations. reported outcomes included vague, qualitative entities such as stress, anxiety, panic, worry, exhaustion, emotional disturbance, ptsd symptoms, depressive symptoms, poor sleep quality, increased alcohol use, and behavior problems. additionally, the fast-moving nature of the pandemic, combined with the challenge of getting behavioral health protocols rapidly approved by institutional review boards, has likely contributed to the scarcity of covid- -related outcome data. given these limitations, we found it difficult to predict with certainty which types of mental health problems are likely to result from covid- . however, several general trends and observations are worth noting and may provide some preliminary assistance to medical planners responsible for anticipating the psychological sequelae of covid- . the data above is consistent with what we already know about the mental health impacts after a disaster: a significant number of people will experience increased stress during the incident, but the majority will not have lasting psychological sequelae. while this is an important perspective, there are also several differences between past pandemics and the current situation. covid- appears to be more similar to influenza outbreaks than to previous coronavirus infections, with respect to high infectivity, low fatality rates, and a high percentage of asymptomatic infections [ ] . from a mental health standpoint, these conditions have the potential to lead to significant anxiety over whether one has the virus and could be unknowingly passing it on to their loved ones. compared with other recent pandemics, covid- has considerably more cases with global spread, causing significant impact on daily lives. no other outbreak in recent history has caused such devastating economic distress or the mass closure of businesses. furthermore, the sheer number of patients infected and hcws exposed could cause significant strain on the mental healthcare system, even if the majority of people affected do well in the long term. with cases continuing to surface, there is still a great degree of uncertainty regarding the final impact this pandemic will have, including when a vaccine will be developed and how long social distancing precautions will need to continue. these additional factors may lead to more severe psychosocial distress and unanticipated psychiatric disease than has been observed in previous pandemics. data on the effects of the covid- pandemic on children and families are currently limited. however, experts anticipate that all families, regardless of whether family members include patients or hcws, will be affected due to disruption of the family structure by closures of schools, financial uncertainty, and possible unemployment [ ] . while mental health professionals attempt to forecast and implement effective treatment for the most vulnerable populations, much is unknown about the long-term mental health effects of largescale disease outbreaks on children, adolescents, and families. evolving data suggests that the greatest risks among these populations will include increased anxiety regarding school and work closures, decreased social and community networks, increased pressure on parents to work from home while providing supervision and distance learning, violence when locked in with abusive family members, and unemployment potentially leading to loss of essentials, starvation, and homelessness. with numerous predictions and peer-reviewed data emerging about the mental health consequences of covid- , one may conclude that healthcare systems and providers must simply anticipate increased demand for all types of psychiatric conditions. however, the information presented above does suggest certain trends that may inform planning more specifically. first and foremost, several studies noted that individuals' levels of anxiety were indirectly correlated with the degree of communication they received about the virus. mental health providers, and particularly those trained in the military as command consultants, are uniquely suited to prepare evidence-based communication tools for patients and fellow clinicians, as well as for community leaders hoping to minimize social panic. such tools should cover what is known about transmission of the virus, for example, how individuals are likely to be infected, what mitigation strategies are most effective, how they should be employed, who is at highest risk for the worst outcomes, who is at greatest risk for psychiatric sequelae, and how mental health may be optimized among affected individuals. communication also includes providing subject matter expertise to medical and community leaders. mental health providers should not wait to be asked; they should prepare succinct talking points and intermittently remind public officials and other senior leaders of the most prominent fears fueling anxiety in the community. additionally, it is important to offer practical and viable suggestions or solutions; providers who present leaders with concerns without solutions will rapidly lose favor with the same individuals they are hoping to influence. second, the aforementioned studies found excessive worry and distress about various covid-related issues. although there are scores of evidence-based interventions likely to be useful for anxiety and depression, two widely available strategies can address both problems effectively, when used in those identified to be appropriate for treatment: cognitive behavioral therapy (cbt) and antidepressant medications [ ] [ ] [ ] . third, post-traumatic stress symptoms were surprisingly prevalent across pandemics and among numerous demographic groups, suggesting that interventions proven to be effective for ptsd may be a worthy investment of training dollars and clinical resources. traditional, - session manualized treatments using prolonged exposure, cognitive processing therapy, and eye movement desensitization and reprocessing are likely to be effective [ ] [ ] [ ] . however, recent data suggests that interpersonal therapy, written exposure therapy (wet), strategically dosed propranolol, and mantram repetition may be equally effective and easier to facilitate via telehealth [ ] [ ] [ ] [ ] . generally, individual psychotherapy has been shown to be more effective than group-based interventions or medications alone for ptsd [ ] . however, in areas where resources are limited, group-based interventions in which cohorts with similar backgrounds can process their experiences together (i.e., front-line workers, covid- survivors, unemployed individuals) may be clinically beneficial. treating ptsd may also improve insomnia, a symptom of ptsd, that was noted to be prevalent in several of the pandemic-related studies cited above. fourth, most responses seen in children during covid- and previous pandemics tend to fall into two major categories-anxiety and restless/disruptive behavior. since the latter can be a manifestation of the former, planning ways to address anxiety in children is likely to be the best investment of limited clinical resources. researchers at the yale university recently demonstrated that coaching for parents in how to manage their anxious children can be as effective as individual cbt conducted with the children themselves [ ] . children may also benefit from individual-or groupbased therapy, especially if they are focused on practical matters, such as how to be good siblings, how to prevent the spread of covid- , and ways to burn off energy that accumulates during isolation. fifth, although entrepreneurs are rapidly adapting their business models to accommodate infection control measures, sustained high unemployment rates and economic depression appear unavoidable. historically, financial crises heighten emotional despair and increase rates of suicide [ , ] . the extent to which covid- will be associated with these impacts is unknown, although some models predict that up to % of jobs lost during covid will be permanent [ ] . planning for the psychological needs of individuals facing economic devastation is challenging. not only is there stigma in acknowledging one's financial situation, but the very nature of the problem itself creates a barrier to accessing treatment. the best planning for these outcomes will likely involve nontraditional approaches, such as partnering with community leaders to educate them about the psychological impact of unemployment, getting the word out about available food and shelter, and creating per diem jobs and apprenticeship opportunities. free support groups and training seminars on topics such as unemployment rights, resume building, and civil service opportunities are likely to make a greater impact than psychotherapy in this population. finally, covid- has created many additional psychological problems not widely emphasized among available data, including domestic violence and child abuse. while physical distancing at home is necessary to prevent the spread of disease, social isolation is also a major tactic used by perpetrators of domestic abuse. strict requirements to maintain isolation may allow perpetrators to gain control by generating guilt in their victims [ ] . isolation from friends, family, and employment plays a role as fewer contacts means fewer people to recognize abuse and provide assistance. typically, % of reports to child protective services come from educators [ ] . because schools and other childcare facilities are closed, families at risk are not likely getting the resources or referrals they need. both substance misuse and domestic abuse are likely to be underreported, yet they are of critical significance. additionally, many minority populations and lowerincome front-line workers are at risk for greater exposure to covid- , greater risk of developing serious medical sequelae, lower likelihood of insurance coverage, and increased institutional bias that may negatively impact their course of treatment [ ] . providers and medical staff who regularly care for these populations should be reminded of the risks incurred by these vulnerable populations and utilized to train their medical peers on how to screen at-risk patients, as well as how to optimize patient access to treatment resources and shelters. there have also been many accounts of discriminatory behaviors against asian americans and pacific islanders (aapi) since the covid- outbreak [ , ] . it is now widely known that in general, the experience of racial discrimination is a determinant of poor mental health [ ] [ ] [ ] . thus, it is important for providers to be aware of these experiences and anticipate increases in the secondary effects of discrimination, such as psychological trauma, anxiety, and depression in these populations. lastly, bereavement will unquestionably be a significant consequence of covid- , yet available literature from covid- and past pandemics is remarkably void of data on grief and bereavement [ ] . the covid- pandemic has changed the landscape of behavioral health dramatically. expanded telehealth capabilities have increased our ability to reach those suffering and provide better patient-centered care, yet these new care delivery systems are not ubiquitously available. furthermore, testing these capabilities may be a trial by fire if predictions about a looming mental health crisis prove accurate. it is therefore important to focus planning efforts on interventions likely to have the greatest impact. evidence-based treatments for ptsd, anxiety, and depression, particularly those more easily delivered using virtual platforms, should become the standard post-covid toolkit for behavioral health clinicians. groupbased interventions will also be critical, particularly for parents, children, and cohorts of similarly impacted individuals, to decrease isolation, normalize experiences, and promote emotional validation. simply being able to direct suffering individuals to support groups and self-help/educational resources may be as impactful as traditional behavioral health interventions. such community-based support is widely used in the american military and is consistent with the doctrinal principles of military disaster response [ ] . this analysis was based on peer-reviewed and non-peer-reviewed scholarly reports, many of which were of limited quality and frequently retrospective in nature. additionally, much of the covid- data is still in pre-print form as of this writing. our rapid review of the existing literature was intended to provide military and civilian mental health planners with timely, actionable data to help guide their decisions regarding staff training and resource allocation. however, we acknowledge that our rapid method of review may have excluded some informative publications that would have been identified if we had used a full prisma systematic review. future research on planning and response to post-pandemic mental health demands should be based on prospective, randomized, controlled, peerreviewed data whenever possible. it is our hope that research will continue into the ongoing psychological impact of covid- . disclaimer the views expressed in this manuscript are those of the author and 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meta-analysis the social determinants of mental health: psychiatrists' roles in addressing discrimination and food insecurity. focus (am psychiatr publ) this article nicely describes the social determinants of mental health, including discrimination and food insecurity cumulative effect of racial discrimination on the mental health of ethnic minorities in the united kingdom supporting adults bereaved through covid- : a rapid review of the impact of previous pandemics on grief and bereavement department of the army. the u.s. army/marine corps counterinsurgency field manual: u.s. army field manual no. - : marine corps warfighting publication no. - publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord- -r yqk tm authors: stephens, elizabeth h.; dearani, joseph a.; guleserian, kristine j. title: courage, fortitude, and effective leadership of surgical teams during covid- date: - - journal: world j pediatr congenit heart surg doi: . / sha: doc_id: cord_uid: r yqk tm the world as we once knew it has been drastically altered secondary to coronavirus disease (covid- ). the impact of these changes, particularly for those practicing in the medical profession, extends beyond the physical to the psychological, emotional, and spiritual. we discuss the factors that contribute to these stresses, way to manage them, and how we as leaders of our teams can inspire resilience and help our colleagues endure these most difficult times. one of the dangers of traumatic and world-changing events such as / -and now the covid- pandemic-is that they can trigger sudden, intense feelings of helplessness and hopelessness. physician and health care workers' physical safety has been the primary focus early on in this crisis and is essential to managing the ongoing pandemic. however, our psychological, emotional, and spiritual well-being are also key to performing under stressful conditions unlike any we have encountered before. even prior to the coronavirus disease (covid- ) pandemic, many clinicians and health care workers were experiencing burnout, as well as stress, anxiety, fatigue, and depression. some experience suicidal thoughts, or turn to substance abuse. the population of health care professionals prone to such experiences extends to those without any underlying or preexisting mental health conditions. today there are not only workplace hardships imposed by the pandemic, but also unprecedented ethical and moral dilemmas that are likely to create or exacerbate existing levels of burnout and mental health-related problems. in contrast to other individually experienced traumatic events when those around us have the emotional reserve to support us, during covid- all members of society are under immense strain, albeit in different manners. based on experience in other outbreaks, the psychological burden may last long after this pandemic is over. , in this commentary, we discuss the factors that test our emotional resilience during this time and how we, as leaders of our surgical teams, can foster fortitude in ourselves and those around us, to ultimately provide the best care possible for our patients. although the terms "wellness" and "mental health" are commonly used in describing these issues, we prefer the term "fortitude." fortitude is defined as mental and emotional strength in the face of difficulty or adversity. although we all strive for peak performance, various nonphysical factors-a conglomeration of mental, emotional, and psychological-can prevent us from doing exactly that. recognizing, grappling with, and harnessing these factors to our advantage is critical during these unprecedented times. cardiothoracic surgery is a high-risk high-reward specialty with one of the lengthiest postgraduate training paradigms followed by many years at the faculty level to attain a high level of technical expertise and judgment. any lack of technical precision or lapse in attention to detail during an operation may have drastic implications for our patients. thus, our specialty puts us at risk for emotional distress and anxiety on a daily basis. many factors contribute to this: time demands, the life and death nature of the operations for every patient with little margin for error, expectations to always appear and perform at "the top of our game," and the strain of managing our personal lives. with the addition of external events such as covid, or professional and personal issues, we are a group of professionals whose fortitude is at risk. beyond these factors, we have been conditioned through our training to constantly perform selfassessment, be receptive to critique, and aim to continuously improve. as popularized by gladwell and ericcson, , those who excel at highly technical tasks largely do not attain such heights by ability alone, but via a long-standing, continual process of practice, critique, and improvement. although this produces superior performance, it also may ingrain in us elements of perfectionism that can be harmful. similarly, growing up in the culture of cardiothoracic surgery fosters an image of indefatigability that becomes a badge of honor. it has become increasingly apparent that cardiothoracic surgeons experience anxiety, depression, and burnout that may prevent us from achieving peak performance. results from the recent society of thoracic surgeons (sts) practice survey demonstrated that nearly % of respondents had feelings of burnout at least a few times a month in the last year . . . the stress is real. the covid pandemic adds a whole new set of stressors to our profession that is already vulnerable. during the peak of the covid- pandemic, surgeons were operating much less, taking us from our daily routine of surgery. our routines confer a sense of purpose, value, predictability, and for many, a sense of control and comfort-after all, we pursued this career because we love to operate and thrive on challenges. the cancellation and rescheduling of cases presented us with exceedingly difficult ethical dilemmas in terms of prioritizing those that can and should be done during justified proscription of "elective" surgeries. who should be offered surgery and when should surgery be done replaced our routine surgical scheduling mindset that was nearly automatic and taken for granted. additional workrelated challenges included physical distancing and isolation in some circumstances. and in the setting of reactivation, there is a perceived demand at many institutions to substantially increase volume over original baseline to "catch up" and operate on patients who have been postponed and all of those currently in need. striking the right balance between safe and complete recovery of services versus the potential increase in viral spread if screening, personal protective equipment (ppe) and physical distancing protocols are not adhered to, contributes substantially to added tension. finally, while high-quality patient care and safety remains the highest priority, the favorable financial portfolio of the cardiovascular service line to a hospital adds additional pressure to the surgical teams to perform cases. an important undercurrent of this pandemic and source of stress for the cardiothoracic surgeon is the uncertainty of the present and future. as surgeons who are most comfortable being in control, our personal and professional lives can feel out of control when uncertainty is present-uncertainty regarding the timeline of reactivation, duration and safety of delay for patients, the constantly changing screening protocols, what protective equipment is most appropriate and what is available, the timing and magnitude of resurgence(s), and the future health of ourselves, our team members, and our families. we constantly strive to do what is best for our patients who need time-sensitive surgery, weighing the risks and benefits of proceeding versus delaying. but what the risks and benefits are during these times, and what is actually best, remains abundantly unclear-a muddy collage of various shades of gray, with no guidelines in textbooks or papers to turn to, and no "levels of evidence" at this time. one recent study based on the covid experience in china identified that the most impactful factors associated with stress among health care workers were personal safety, concern for their families, and patient mortality. in another study from china, the biggest factors were loss of control, vulnerability to infection, fear for personal health, and spread of the virus. studies have shown that the mental health burden during covid is considerable. in a study by lai et al, % demonstrated depression, % anxiety, and % insomnia, with frontline workers at highest risk. so, the stress is real. covid- not only adds a considerable burden of strain related to work, but also impacts our personal lives. first, how to minimize the risk and impact of exposure experienced by our families as a result of our work at the hospital-whether that be in the form of a protocol for "decontamination" before interacting with family when returning from work, or sheltering alone. for some, children are now home and having to be homeschooled. with another working parent who is trying to juggle a career from home, this is exceedingly difficult. for others with young children, the previously utilized childcare is no longer available. some have been faced with trying to assist and care for elderly parents, or other family members with disabilities, often remotely. a spouse or partner may be out of work, adding additional financial and emotional tension. and still others are faced with social distancing while living alone, which is an added strain. many conveniences that we relied on are not available, whether that be care for our home, our pets, or obtaining basic necessities. the simple act of going to the grocery store with the potential for infection transmission from either people density or significant hand contact with objects (ie, groceries, carts, etc), or both, accounts for a whole new level of incalculable risk and essentially unavoidable stress. the expectation of wearing masks in public places, handwashing, and physical distancing seems to have no end in sight, adding enormous strain. for all of us, we are worrying and trying to care for our families and loved ones in the midst of a pandemic that is particularly dangerous for certain "at risk" populations . . . and nearly every person has one or multiple family members who fall into this category . . . the stress is real. the stressors of covid not only involve our work lives and personal lives but extends throughout our entire hospital care team and our patients, thereby further impacting us and our ability to provide optimal patient care. everyone in the workplace has been and continues to be affected, all members of the surgical team in the operating room, intensive care unit, wards-from surgeons to secretaries. team management for some has changed to shift work of alternating teams, with some staying at home and others working remotely. many of our nonclinical team members are working remotely at home, which adds a myriad of additional strains-less efficiency for those at work and more distractions for those at home. there is lack of work-home structure and boundaries, lack of the work infrastructure, and professional and personal support systems. added into this mix are elements such as homeschooling for children or needing to provide childcare while also working, or remotely caring for parents/grandparents who are at increased risk. many are facing substantial financial strain, which can range from pay cuts among other family members no longer generating income. for families with lower socioeconomic status, some children relied on school lunch meals that ceased to be available, adding more personal stress. furlough is particularly difficult for members of our teams as it cuts off their professional role and value, disrupts the camaraderie and support system of work, and eliminates needed income. the stress felt by our patients and their families is another important component, particularly in cardiothoracic surgery where some risk of mortality, albeit small in most cases, is always present. whether it be the restrictions imposed on families limiting their presence with patients during a hospital stay, to difficulty communicating with and supporting their loved ones, to worrying about contracting covid, to their own financial stress, the additional burden on our patients and their families also impacts us, making the stress and anxiety tangible. as cardiothoracic surgeons, we are in many respects the natural leaders of our respective teams and the ones to set the tone and example for others. communication and fostering connectivity during this time of crisis is crucial. weekly leadership discussions and town halls, conference calls, large interactive webinars, and/or smaller scale virtual meetings using webex/ zoom-type platforms are facilitating our teams' ability to stay informed. they also enable members to relay their evolving needs and concerns and us to relay ours. listening to our team members and specifically asking them about their concerns and needs is vital to such discussions. acknowledging their stresses and recognizing that previously simple tasks are now more complex can be particularly reassuring and meaningful. although we are all physically distant, remaining connected intellectually and emotionally is critically important. sincere gratitude from leaders and between coworkers can be a powerful source of support. in this time of change, our leadership styles and strategies must evolve in response to the changing needs of our team, but in all circumstances, we should lead by example. the first step in fostering fortitude in ourselves and our teams is recognition of the increased stress and the risk of declining wellness during this time. the second step is learning to recognize and acknowledge symptoms of diminishing fortitude, such as fatigue, fear, anxiety, depersonalization/cynicism, emotional exhaustion, low sense of accomplishment related to work, withdrawal, and guilt. , and the third step is developing habits to improve fortitude. maddaus has identified key habits that improve a surgeon's resilience: sleep, exercise, mindfulness and meditation, gratitude, self-compassion, and connection to others. in the review by fann et al, factors promoting resilience encompass individual, family, organizational, and community components and an adapted list is provided certain personality traits, such as being grounded in reality, having a robust value system, and the ability and willingness to improvise when faced with challenges are also correlated with resilience. specifically within pandemics including covid, studies in chinese health care workers have identified optimism and altruism as elements that may decrease psychological strain. , in the setting of covid, practical measures such as providing ppe and clear practice guidelines were shown to decrease stress, as was appreciation of their work. , another recent survey of the experience in china identified correct guidance, safeguards against transmission, positive attitude of staff, and safety of family members as having the biggest impact on stress of staff members. positive coping mechanisms included strict protective measures, knowledge of viral spread, and a positive self-attitude, with seeking help from family and friends also cited as important. as leaders, we can aid in this by providing clear communication and guidelines, implementing safeguards against transmission, maintaining a positive attitude, and managing our stress adequately, while expressing appreciation for our team's work and dedication. however, as stanford medicine's chief wellness officer, tait shanafelt, md, stated "we should not be recycling the wellness offerings of the past, as if retooled versions of those approaches are the current needs . . . we need to approach this situation with fresh eyes, ask our people what they need, develop our response based on the needs they've expressed, and effectively and compassionately communicate with them." part of approaching this topic differently during covid is the platform-gyms and yoga studios are closed, social distancing does not allow for coffee with a friend, those in densely populated areas cannot enjoy parks, and other support systems that depend on gatherings, such as religious services, are on hold. during this time, we rely on technology to keep us connected and have to be creative in redefining stressrelieving activities we once enjoyed or create new ones. of course, ensuring and encouraging adequate and appropriate mental health care when needed may help physicians and health care workers develop improved emotional and cognitive resilience to withstand the impact of such traumatic events. times such as this pandemic test our fortitude. cardiothoracic surgery is the prototype specialty that has a complex interface between patient and technology, and seamless, effective teamwork is necessary for good outcomes. as cardiothoracic surgeons, we are innate leaders. the cardiothoracic surgeon has courage by nature and a "never give up" attitude. in a specialty where every day is "game seven" and the expectation is perfect performance each and every time, the stress level is already high. similar to the technical (physical) skills and judgment that we have developed over the years to become excellent surgeons, cultivation of skills related to emotional resilience are also critical to ensure that we maintain competence and compassion for our patients, our teams, and our families, while upholding our uncompromising demand for excellence. as abigail adams wrote to her son john quincy adams during the american revolution "it is not in the still calm of life, or the repose of a pacific station, that great characters are formed" rather that "the habits of a vigorous mind are formed in contending with difficulties. great necessities call out great virtues." the importance of our leadership in this most turbulent time, including the fostering of fortitude in us and others, should not be underestimated. the author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. the author(s) received no financial support for the research, authorship, and/or publication of this article. the role of risk perception in willingness to respond to the - west african ebola outbreak: a qualitative study of international health care workers healthcare workers emotions, perceived stressors and coping strategies during a mers-cov outbreak outliers: the story of success. little, brown and company deliberate practice and acquisition of expert performance: a general overview resilience and overcoming adversity physician burnout: are we treating the symptoms instead of the disease? the society of thoracic surgeons thoracic surgery practice and access task force- workforce report psychological impact and coping strategies of frontline medical staff in hunan between january and march during the outbreak of coronavirus disease (covid ) in hubei, china the psychological impact of severe acute respiratory syndrome outbreak on healthcare workers in emergency departments and how they cope factors associated with mental health outcomes among health care workers exposed to coronavirus disease center for disease control and prevention. covid- : coping with stress. center for disease control and prevention the resilience bank account: skills for optimal performance avoiding burnout: the personal health habits and wellness practices of us surgeons if every fifth physician is affected by burnout, what about the other four? resilience strategies of experienced physicians promoting psychological resilience in the u.s. military. rand health q mental health of nurses working at a government-designated hospital during a mers-cov outbreak: a cross-sectional study the psychological impact of the sars epidemic on hospital employees in china: exposure, risk perception, and altruistic acceptance of risk risk perception and impact of severe acute respiratory syndrome (sars) on work and personal lives of healthcare workers in singapore: what can we learn? med care understanding and addressing sources of anxiety among health care professionals during the covid- pandemic key: cord- -dmkdsy r authors: seglem, k. b.; Ørstavik, r.; torvik, f. a.; røysamb, e.; vollrath, m. title: education differences in sickness absence and the role of health behaviors: a prospective twin study date: - - journal: bmc public health doi: . /s - - -y sha: doc_id: cord_uid: dmkdsy r background: long-term sickness absences burden the economy in many industrialized countries. both educational attainment and health behaviors are well-known predictors of sickness absence. it remains, however, unclear whether these associations are causal or due to confounding factors. the co-twin control method allows examining causal hypotheses by controlling for familial confounding (shared genes and environment). in this study, we applied this design to study the role of education and health behaviors in sickness absence, taking sex and cohort differences into account. methods: participants were two cohorts of in total norwegian twins born to (older cohort, mean age at questionnaire = . , . % women), and to (younger cohort, mean age at questionnaire = . , . % women). both cohorts had reported their health behaviors (smoking, physical activity and body mass index (bmi)) through a questionnaire during the s. data on the twins’ educational attainment and long-term sickness absences between and were retrieved from norwegian national registries. random (individual-level) and fixed (within-twin pair) effects regression models were used to measure the associations between educational attainment, health behaviours and sickness absence and to test the effects of possible familial confounding. results: low education and poor health behaviors were associated with a higher proportion of sickness absence at the individual level. there were stronger effects of health behaviors on sickness absence in women, and in the older cohort, whereas the effect of educational attainment was similar across sex and cohorts. after adjustment for unobserved familial factors (genetic and environmental factors shared by twin pairs), the associations were strongly attenuated and non-significant, with the exception of health behaviors and sickness absence among men in the older cohort. conclusions: the associations between educational attainment, health behaviors, and sickness absence seem to be confounded by unobserved familial factors shared by co-twins. however, the association between health behaviors and sickness absence was consistent with a causal effect among men in the older cohort. future studies should consider familial confounding, as well as sex and age/cohort differences, when assessing associations between education, health behaviors and sickness absence. supplementary information: supplementary information accompanies this paper at . /s - - -y. high levels of sickness absence are a growing concern in many industrialized countries. norway has one of the highest sickness absence rates with approximately % of working days lost over the past decade [ ] . sickness absence increases considerably across age, and women have a higher level than men [ ] . for an individual, staying away from work when ill is often necessary to ensure good health. long term sickness absence can, however, also have a negative impact on a person's health, and is a risk factor for permanent disability and lifelong exclusion from the labor market [ , ] . despite sickness absence being more than a measure of morbidity, e.g. influenced by the nature of one's work [ , ] and sociopolitical structures [ ] , there is a clear education gradient in sickness absence that parallels the well-known education gradient in health. individuals with lower educational attainment, a key dimension of socioeconomic status, are at higher risk of sickness absence and labor market exclusion [ ] . studies of education and sickness absence borrow largely from theoretical perspectives on the widely studied "education-health gradient" [ ] , thus positing that educational attainment has a causal effect on sickness absence [ , ] . an important mechanism, partly explaining education differences in health, is differences in health behaviors [ , ] . knowledge about the influence of health behaviors on sickness absence is limited [ ] [ ] [ ] [ ] [ ] [ ] [ ] , but lifestyle or health behaviors have been documented as one explanation for socioeconomic differences in sickness absence [ , , , , ] . the etiological processes underlying the association between education, health behaviors and sickness absence is poorly understood, but results from some studies indicate that these associations may be confounded by unobserved familial factors, i.e. genetic and/or environmental factors shared by co-twins [ , ] . education is considered as an important individual determinant of later medically confirmed sickness absence [ , , ] . individuals with higher educational level have lower levels of sickness absence than those with lower educational level, indicating better health and worklife functioning [ ] . education is typically completed by early adulthood, while other indicators of socioeconomic status, such as occupational class and income, are determined later [ , ] . compared to income, educational attainment is a stronger socioeconomic determinant of sickness absence in societies where differences in income levels are relatively low, such as in nordic countries [ , ] , which is why we focus on education in the present study. furthermore, education differs from other socio-economic indicators in that it primarily indicates differences in non-material resources such as general knowledge, and health literacy, which maylead to healthier behaviors [ ] . the importance of lifestyle or health behaviors for sickness absence has been studied to a limited degree only. much of the evidence focuses on single health behaviors, is based on relatively small sample sizes and findings have been mixed [ ] [ ] [ ] [ ] [ ] [ ] . however, a large observational study of cohorts from france, finland, and the uk found that lifestyle-related factors including bmi, physical activity, smoking and alcohol consumption were all associated with sickness absence [ ] . two previous studies have investigated whether lifestyle or health behaviors explain educational differences in sickness absence [ , ] . a population-based study among year olds in finland, found that lifestyle factors including smoking, physical exercise, sleeping problems, alcohol consumption and obesity altoghether explained about % of the educational differences in sickness absence, with a stronger effect among women [ ] . a study of workers in six companies in the netherlands, found that overweight/ obesity explained % of educational differences, after working conditions and perceived general health was accounted for [ ] . together, these studies indicate that lifestyle-related factors play a role in the mechanisms through which education affects sickness absence. however, these studies were observational, thus, inferences about causality could not be made. there is increasing appreciation that health behaviors do not co-occur within individuals by chance, but that they tend to cluster. those who smoke cigarettes are more likely to drink excessive amounts of alcohol and less likely to eat healthy and be physically active [ ] [ ] [ ] [ ] . poor health behaviors are also more prevalent among individuals with less education [ ] . instead of targeting specific health behaviors, some argue that multiple behaviors need to be targeted, in order for interventions to have an effect on health [ , ] . a previous randomized trial showed that an intervention involving physical exercise, health advice and smoking cessation had an effect on sickness absence [ ] . other intervention studies limited to physical exercise [ ] and overweight [ ] alone, did not appear to have any effects. based on the evident clustering of health behaviors and that the sum of several health behaviors seems more important for sickness absence than a particular health behavior, we use a health behavior index in the present study to focus on broad explanations for the role of health behaviors. recently, a growing body of studies using causal inference designs failed to fully support the hypothesis that socio-economic status exerts a causal effect on health [ ] [ ] [ ] [ ] . the co-twin control method represents one such design, where the aim is to mimic a counterfactual situation: monozygotic (mz) twin pairs are genetically identical while dizygotic (dz) pairs share on average % of their genes, just like other siblings. if raised together, both share their family environment. in the co-twin control method, the size of associations between exposure and outcome is compared with the corresponding within mz (and dz) associations. for example, if educational attainment statistically predicts sickness absence in the population, and we find a similar effect among mz-twins with different levels of educational attainment (within pair analyses), this supports that educational attainment is causally related to sickness absence. if, on the other hand, we observe that the populationbased association disappear in the within pair analyses, the initial association is probably due to confounding by unmeasured confounding by genes or shared environmental factors. subgroup analyses within mz and dz twins pairs allow to differentiate between confounding due to genes or shared environment. a previous twin study of young norwegian adults based partly on the same data as the present study [ ] showed that within dz twins, the effect of education on sickness absence was attenuated. within mz twins, who share both the family environment and all of their genes, the effect of education on sickness absence was negligible and reduced to non-significance, indicating that mainly genetic influences explained the association between education and sickness absence in young adulthood. in an older sample of middle-aged swedish twins, samuelsson and colleagues [ ] found that the association between education and disability pensioning, a construct strongly related to sickness absence, was also confounded by familial factors. in contrast, a twin study of health behaviors and risk for disability pensioning found an effect independent of familial factors [ ] . in this paper, we aim to add to the existing literature on educational and health behavior differences in sickness absence, by employing a co-twin control design. based on previous findings [ , ] , we hypothesized that educational attainment and health behaviors are independent predictors of sickness absence, and that health behaviors partly explain educational differences in sickness absence. we further hypothesized, based on previous twin studies [ , , ] , that the association between education and sickness absence would not be consistent with a causal explanation, but that the association between health behaviors and sickness absence would. due to well-known sex and age differences in level of sickness absence, but limited knowledge of causal factors underlying these differences [ ] , we will explore the effects by age/birth cohort and sex subgroups. information from three norwegian registries was linked using national identity numbers. the first was the norwegian twin registry, comprising information on , twins born between and and between and , respectively. for the present study, we selected two cohorts of twins. the older cohort was born between and and had completed a health questionnaire between and (median = ). the younger cohort of twins was born between and and had completed a similar health questionnaire between and . the mean age of the two cohorts when answering the questionnaires was . years and . years, respectively. the second registry (the historical-event database) contained information on each twin's sickness absence and employment. the third registry contained information about each twin's highest completed education (the norwegian educational database). sickness absences were retrieved for the period to , ensuring that the twins had completed the health questionnaires before the first recorded sickness absence. we excluded participants who had fewer than working days registered throughout the year follow-up period. for the older cohort, only same-sex twins were available. among the final sample of twins, there were complete pairs ( monozygotic (mz) male, dizygotic (dz) male, mz female, dz female, and unlike-sex twin pairs) and single twins. questionnaire items and genotyping of a subsample determined zygosity [ ] . in this longitudinal, population-based twin study, we employed a co-twin control design. the basics of this design is explained in the introduction. the regional committee for medical and health research ethics (case / ) approved of the study. we computed sickness absence taking the ratio of sickness absence days to contracted working days, ranging from to %. the mandatory norwegian insurance scheme covers sickness absences exceeding days and up days during a calendar year. we excluded sickness absences granted for problems or illnesses related to "pregnancy, childbearing, family planning" [ ] since those were relevant for women in the younger cohort only. data on educational attainment was available annually from to from the norwegian educational database administered by statistics norway. here the norwegian standard classification of education [ ] distinguished eight levels, ranging from "no education" to "ph.d. or equivalent". we simplified this classification by merging technical diplomas with undergraduate levels and ph.d.s with master degrees, resulting in five educational levels. to ensure completeness, we used data from when the youngest participants were years old. health-related lifestyle factors were based on selfreported information. leisure-time physical activity ("how often do you exercise?") included categories of never, less than once a week, one to two times per week and three times per week or more. categories were reverse coded prior to analyses, so that higher score reflects less physical activity. body mass index (bmi) was used as a proxy indicator for diet or overeating [ , ] . bmi was calculated based on weight ("how much do you weigh?") and height ("how tall are you?"). we first categorized bmi as underweight (lower than . kg/ m ), normal weight ( . - . kg/m ), overweight ( . - . kg/m ), and obesity ( . kg/m or higher). due to few individuals in the underweight and obese categories and a u-shaped association with sickness absence, we dichotomized bmi into normal weight ( ) versus not ( ) . smoking was assessed with the questions "do you currently smoke?" and "if you quit smoking, how old were you then?". we categorized smoking status as current or past smoker ( ) and non-smoker ( ). the internal-consistency reliability for the three health behavior variables was low as expected, i.e. kr- = . . a health behavior composite score was computed using principal component analysis (pca) of the three health behavior measures, and saving the factor scores (i.e., standardized, weighted sum score). the kaiser-meyer-olkin (kmo) measure verified the sampling adequacy for the analysis, kmo = . , and all kmo values for individual items were > . which is above the acceptable limit of . [ ] . bartlett's test of sphericity χ ( ) = . , p = < . , indicated that correlations between items were sufficiently large for pca. the items clustered on one component with an eigenvalue over kaiser's criterion of and explained . % of the variance. factor loadings were . for bmi, . for physical activity and . for smoking. higher score reflects less healthy behaviors, i.e. an unhealthy lifestyle. sex referred to that which was assigned at birth (men = , women = ), and was together with cohort (birth year) available from the norwegian twin registry. models included observations with complete information on all model variables. number of missing cases are reported in table . we performed the analyses using stata se version [ ] . careful inspection of scatterplots showed that education, health behaviors and sickness absence were linearly related. in the first set of analyses, the associations of education and health behaviors with sickness absencewere assessed with random-effects generalized least squares (gls) regression using the twins as individuals. standard errors and cis were adjusted for dependence between twins in pairs using robust variances (stata command xtreg, option re). we first estimated a model including the effects of education, sex and cohort on sickness absence, then added the effect of the health behavior composite. sex and cohort differences were examined using two-and three-way interaction terms. we finally calculated to what extent the association between education and sickness absence were reduced when health behaviors were included in the regression equation. secondly, we repeated the analyses using within twin pair models, by running fixed-effects models separately for monozygotic and dizygotic twins (stata command xtreg, option fe). this approach separates the effects of familial and genetic confounding, respectively. an attenuation of estimates in dz twin pairs would indicate familial (genes and or shared environment) confounding while further attenuation in mz twin pairs would suggest genetic confounding [ ] . models were run for the full sample and subgroups of sex and cohorts . descriptives table provides descriptive statistics for each cohort and sex. in the older and younger. cohorts, . % versus . % had higher education (beyond upper secondary),, t ( ) = − . , p < . . men scored higher on the health behavior composite, indicating more unhealthy behaviors, than women in both the older, t ( ) = . , p < . , and in younger cohort, t ( ) = . , p = . . the older cohort scored higher on unhealthy behaviors t ( ) = . , p < . . the overall incidence of any sickness absence was . %, i.e. a majority of participants were granted sickness absence during the years to . a total of . % of all working days between and were lost to sickness absence. there was a lower sickness absence proportion among men ( . % in the older cohort and . % in the younger cohort, t ( ) = . , p < . ) than among women ( . % in the older cohort and . % in the younger cohort, t ( ) = . , p < . ). figure shows a bar graph of educational attainment differences in annual mean sickness absence proportion in the follow-up years from to among women and men in the older and younger cohort. in the total sample, the difference in sickness absence varied from . % among those with lowest education (primary/ lower secondary) to . % among those with the highest level (master's degree or higher). despite differing levels of sickness absence, there was a clear negative relationship with educational attainment in all subgroups. table shows the results of the random-effect models predicting proportion of sickness absence from educational attainment and health behaviors for the total sample, including tests of interaction with sex and cohort. educational attainment was standardized to be directly comparable to health behaviors. the first model shows the association between education and sickness absence adjusted for birth cohort and sex, and accounting for twin dependency. the regression coefficient indicates that as educational attainment increased by one standard deviation (sd), the mean annual sickness absence proportion decreased with . percentage points. in unstandardized units, and more comparable to the raw data in fig. , the coefficient was − . ( % ci: − . , − . ), indicating that with each increasing level in educational attainment, sickness absence decreased with . percentage points. this means that based on the general sickness absence proportion of . %, one sd increase in education reduces sickness absence by %, while each increase in education level reduces sickness absence with %. the between r-squared for model indicated that % of the individual variation in sickness absence was explained. in the second model we added the health behavior composite. this resulted in a % reduction in the education-sickness absence coefficient, indicating a small degree of overlap and potential mediation. yet, both education and health behaviors showed unique statistically significant contributions. based on the general sickness absence proportion of . %, one sd increase in unhealthy behaviors was prospectively associated with . percentage points or a % increase in sickness absence. the between r-squared for the model was . , indicating that the composite of health behaviors only explained an additional % of the individual variation in sickness absence. models and include two-way interactions to investigate whether there were statistically significant sex and cohort effects in the education gradient in sickness absence. results indicated no interaction effects. model shows a stronger effect of health behaviors on sickness absence among women than men, and model a weaker effect of health behaviors in the younger than the older cohort. there were no statistically significant three-way interactions. to better understand how education and health behaviors are associated and since health behaviors are generally regarded as mediators of the effect of education on sickness absence, we ran an additional model predicting health behaviors from educational attainment for the whole sample, adjusting for birth year and sex, and accounting for twin dependency (not shown in table). next, we tested sex and cohort differences in table shows the associations between education, health behaviors, and sickness absence within dz and mz twin pairs for the total sample. in dz pairs, the association between education and sickness absence remained, i.e. higher education was associated with lower sickness absence. this association was slightly attenuated when adding health behaviors in model , but health behaviors did not show a statistically significant association with sickness absence. within mz pairs, the association of both education and health behaviors with sickness absence was small and not statistically significant. figure shows the standardized regression coefficients for the associations between all main variables for the total sample and within mz pairs (full adjustment of familial confounders) presented as a mediation model. this shows that the association of health behaviors and educational attainment with sickness absence was confounded by familial (shared environmental and/or genetic) factors. the association between educational attainment and health behaviors, on the other hand, was attenuated, yet remained statistically significant after control for familial factors. next, we ran fixed-effect models for each sex and cohort group separately (see figures s a-d in the online supplementary material). fixed-effects models were run with dz and mz twin pairs combined to increase statistical power when running analyses in subgroups. results were similar as for the fixed-effect model in the total sample, but with some exceptions. the most notable and robust difference was found between the cohorts in the association between educational attainment and health behaviors. in the older cohort the educationhealth behaviors association almost disappeared after adjusting for familial factors. in contrast, the educationhealth behaviors association in the younger cohort was somewhat attenuated and remained statistically significant (women: β = −. , p = . , men: β = −. , p < . ). we checked the robustness of this association by running analyses within mz twins only, confirming the results (women: β = −. , % ci = − . , − . , p = . ; men: β = −. , % ci = − . , − . , p = . ). due to the similar results for women and men in the younger cohort, we combined the sexes to increase statistical power. in the younger cohort, the association between education and health behaviors was similar in mz and dz twins (β = −. , % ci = − . , − . , p = . and β = −. , % ci = − . , − . , p = . , respectively), indicating partial confounding by mainly shared environmental factors. another exception was the association between health behaviors and sickness absence, which among men in the older cohort was enhanced and statistically significant in the within mz twin analyses (β = . , % ci = . , . , p = . ). to validate our findings, we performed several robustness checks. we reran the analyses with years of education (m = . , sd = . , range = - ) obtained from national registry data, yielding essentially the same results as with five educational levels (see tables s and s in the online supplementary material). second, we computed separate analyses for those who had completed their highest education before participating in the health study, to ensure temporal alignment. the analyses yielded essentially the same results (see tables s and s ). since more participants in the younger cohort had not completed their highest level of education before participating in the health study ( . %), we ran table within-twin pair associations between education, health behaviors and sickness absence in the total sample education and health behaviors were standardized prior to model entry additional models to check whether this affected the results in the younger cohort ( figures s a and b) . no substantial differences were found. the key findings of the present study were that on the population level, educational attainment and health behaviors were prospectively associated with sickness absence among both women and men, as well as older and younger cohorts. controlling for genetic and shared environmental factors, however, showed that these associations appeared to be confounded by familial factors and were therefore probably not causal. one exception was the association between health behaviors and sickness absence among men in the older cohort. these findings are an important contribution to the sickness absence literature, suggesting that a larger focus on the role of genetic mechanisms is warranted. the main findings are subsequently discussed. the findings that low educational attainment and poor health behaviors were associated with higher levels of sickness absence replicates previous observational studies (e.g. , ) . in addition to both education and health behaviors exerting main effects on sickness absence, there was also a degree of overlap between them. as previously shown in other studies [ , ] , we found that the effect of education on sickness absence was reduced once health behaviors were controlled for. this is in line with theories of health behaviors being mediators in the education-health outcome link [ , ] . however, our analyses of within-twin pair differences might give reason to reconsider these interrelationships. adjusting for factors shared by co-twins reduced the associations between education and sickness absence and between health behaviors and sickness absence (except for men in the older cohort). the reduction of the educationsickness absence association in the younger cohort sample has previously been documented [ ] . our study confirms these findings for an even longer follow-up time of years, until the year , when the younger cohort have reached the ages - , as well as extending these findings to hold also for the older cohort with follow-up until retirement age. we are not aware of any other previous twin studies that investigated whether the interrelationships between education, health behaviors and sickness absence are consistent with causal hypotheses. however, our results are consistent with a previous twin study of disability pensioning in sweden, showing that the association between education and disability pensioning is confounded by familial factors [ ] . another swedish twin study showed that the association between a combination score of health behaviors and disability pensioning was unclear [ ] . this could reflect that ropponen and svedberg combined alcohol consumption, which they found to have a protective effect, together with tobacco use and low physical activity, found to be risk factors. previous studies have found a u-shaped association between alcohol use and sickness absence, with abstainers and high level users having more sickness absence [ , ] . at the same time, alcohol use shows a more complex and heterogeneous pattern of association with socio-economic status (ses) than many other public health challenges, with higher ses often being associated with higher alcohol consumption [ ] . different ways of operationalizing and combining health behaviors make comparisons across studies complicated. nevertheless, knowledge of how various health behaviors interact in different groups or contexts is important for researchers and policy makers in the hope of improving health-related behaviors and reduce sickness absence in the population. in the present study, results indicated a causal link between health behaviors and sickness absence among men in the older cohort. in the younger cohort, health behaviors may not have had enough time to exert an effect on fig. all standardized coefficients from regression models with total sample adjusted for sex, cohort and twin dependency (first line) and within mz twins (second line). coefficients for sickness absence regressed on health behaviors (higher score indicates less healthy behaviors) was additionally adjusted for educational attainment health or sickness absence. why health behaviors did not seem to have a causal link to sickness absence among women in the older cohort, however, is more difficult to explain. one suggestion is that there may be selection effects, as the older cohort belongs to a generation where women typically stayed more at home. therefore it may have been easier for these women than the men to reduce their participation in or exit the labour force if experiencing health problems. however, women in the older cohort had higher levels of sickness absence, indicating that such selection effects were not overriding. another observation is that men in the older cohort showed more unfavourable health behaviours as measured by the composite and higher bmi in particular. this could indicate that sickness absence due to lifestyle diseases may be more prevalent among older men than women. this is consistent with previous observational studies showing that obesity is particularly associated with sickness absence due to digestive and circulatory diseases [ ] , and that several health behaviors, including smoking and bmi, has shown stronger associations with medically confirmed sickness absence among men than women [ ] . we also examined whether the association between education and health behaviors was consistent with a causal explanation. interestingly, the association between educational attainment and health behaviors was only partly confounded and remained statistically significant after familial control in the younger cohort, but not the older. this shows that education and health behaviors have become more causally related in younger cohorts. this corresponds to previous studies in the us showing that health behaviors exert a stronger impact on the education gap in mortality at younger than older ages [ ] , and that risky health behaviors have become more concentrated among more recent cohorts of individuals with lower education [ ] . this could be due to improved quality of education, more health campaigns and interventions from health authorities, or it could be due to sociocultural mechanisms leading to clustering of better or worse health behaviors in the upper and lower end of socioeconomic positions. the latter explanation also fits with the increasing socioeconomic segregation seen in populations of many industrialized countries [ ] . the strengths of this study include the prospective study design, the long follow-up period, the fact that we relied on high-quality registry data regarding exposure and outcome, and the genetically informative design that captured population data covering the entire age span of the norwegian working population. furthermore, in the present study, persons with at least employment days, and regardless of the hours of employment, during the -year follow-up period were included. with these wide inclusion criteria, we are likely to include persons who only work part-time due to health reasons and persons who fall out of the labour market for various reasons. by including all persons who are eligible for sickness absence benefits some time during follow-up, we include a broader segment of the population, which we believe make the findings more generalizable with regard to sickness absence in the population. the limitations of the study are first, that despite being able to use twin pairs as optimal matching of cases and controls, not all putative factors could be controlled for in this study. while the within-pair estimates are free from confounding from genetic and shared environmental facors, these estimates may be biased by non-shared confounders [ ] . for example, health problems early in life in one twin may explain why this twin has lower education as well as poorer health behaviors such as lower physical activity. second, sickness absence is a complex construct and our study has taken into account only some influential factors. risk factors specific to work, family situation attributable to the person or work-home interference, as well as psychological trait factors may be important and should be considered when interpreting our findings. third, due to restrictions in data accessibility we were only able to follow the twins until . there has (except from the current situation with covid- ) however, been no major changes in patterns of sickness absence or levels of employment since. fourth, we only had available information on long term sickness absence, i.e. at least days. we therefore do not know if the same results apply for short term sickness absence. finally, the results may not be generalizable to all settings, and are best generalizable to nordic and european countries with similar welfare schemes, attitudes and cultures of health behaviors. to conclude, both educational attainment and health behaviors were independently associated with level of sickness absence, but these associations were strongly confounded by familial factors. based on these findings, interventions aiming to increase educational attainment or improve overall health behaviors, despite their potential importance in improving public health, might not be the best strategy to reduce the rate of sickness absence. future studies investigating education and health behaviors as predictors of sickness absence need to take familial confounding into account, as well as consider variations between sex and age/cohort groups. supplementary information accompanies this paper at https://doi.org/ . /s - - -y. additional file . oecd economic surveys: norway risk factors for sick leave-general studies sickness absence as a risk factor for job termination, unemployment, and disability pension among temporary and permanent employees is there an association between long-term sick leave and disability pension and unemployment beyond the effect of health status?-a cohort study sickness absence as a measure of health status and functioning: from the uk whitehall ii study explaining socioeconomic differences in sickness absence: the whitehall ii study more and better research needed on sickness 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the gap gets bigger: changes in mortality and life expectancy, by education socioeconomic segregation in european capital cities. increasing separation between poor and rich sibling comparison designs: bias from non-shared confounders and measurement error publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations data on zygosity on the twins used in this study was obtained from the norwegian twin registry, the norwegian institute of public health. we are very grateful to the twins for their participation. the raw data is confidential and cannot readily be shared. data may be shared with researchers obtaining permissions from the norwegian twin registry, statistics norway, and the regional committees for medical and health research ethics. the study was approved by the regional committees for medical and health research ethics (reference number: / rek sør-øst d). written informed consent was obtained from participants born - . for participants born - an exemption from the duty of confidentiality, cf. the norwegian health research act, was approved by the regional committees for medical and health research ethics. not applicable. the authors declare that they have no competing interests. key: cord- - nwq vxk authors: russo, giuliano; fronteira, inês; jesus, tiago silva; buchan, james title: understanding nurses’ dual practice: a scoping review of what we know and what we still need to ask on nurses holding multiple jobs date: - - journal: hum resour health doi: . /s - - -x sha: doc_id: cord_uid: nwq vxk background: mounting evidence suggests that holding multiple concurrent jobs in public and private (dual practice) is common among health workers in low- as well as high-income countries. nurses are world’s largest health professional workforce and a critical resource for achieving universal health coverage. nonetheless, little is known about nurses’ engagement with dual practice. methods: we conducted a scoping review of the literature on nurses’ dual practice with the objective of generating hypotheses on its nature and consequences, and define a research agenda on the phenomenon. the arksey and o’malley’s methodological steps were followed to develop the research questions, identify relevant studies, include/exclude studies, extract the data, and report the findings. prisma guidelines were additionally used to conduct the review and report on results. results: of the initial records identified, a total of met the inclusion criteria for nurses’ dual practice; the vast majority ( %) were peer-reviewed publications, followed by nursing magazine publications ( %), reports, and doctoral dissertations. twenty publications focused on high-income countries, on low- or middle-income ones, and two had a multi country perspective. although holding multiple jobs not always amounted to dual practice, several ways were found for public-sector nurses to engage concomitantly in public and private employments, in regulated as well as in informal, casual fashions. some of these forms were reported as particularly prevalent, from over % in australia, canada, and the uk, to % in south africa. the opportunity to increase a meagre salary, but also a dissatisfaction with the main job and the flexibility offered by multiple job-holding arrangements, were among the reported reasons for engaging in these practices. discussion and conclusions: limited and mostly circumstantial evidence exists on nurses’ dual practice, with the few existing studies suggesting that the phenomenon is likely to be very common and carry implications for health systems and nurses’ welfare worldwide. we offer an agenda for future research to consolidate the existing evidence and to further explore nurses’ motivation; without a better understanding of nurse dual practice, this will continue to be a largely ‘hidden’ element in nursing workforce policy and practice, with an unclear impact on the delivery of care. electronic supplementary material: the online version of this article ( . /s - - -x) contains supplementary material, which is available to authorized users. health workers' dual practice has been identified as one of the priority research areas in the human resources for health domain [ ] . there is a concern among policymakers and patients alike that simultaneous engagement with public and private sector activities jeopardise the availability of professionals and the quality of services in the public sector and divert patients towards costlier private care, therefore putting at risk the attainment of universal health coverage (uhc) goals [ , ] . 'dual practice' in the health sector has been defined as health workers' concomitant engagement in public and private sector clinical activities, with the public sector job representing the 'primary' one to which the largest proportion of working hours are allocated [ ] . although very common worldwide, the practice has been traditionally treated with suspicion by the public health and health system research literature, amid fears that it may compromise the supply of public services [ ] and encourage absenteeism in public institutions [ ] , as well as the selection and diversion of patients towards private services [ ] . scholars have highlighted the possible potential benefits of the practice, such as the opportunity it offers to provide a wider range of health services to the population and to retain underpaid workers in the public sector [ ] . others have paid attention to the regulatory aspects [ ] , with some focusing on the systems' governance and institutions [ ] and others on the incentives to be offered to achieve the desired level of service provision [ , ] . substantial literature exists on physicians' dual practice [ , ] , most recently building up evidence on its prevalence, forms, and drivers worldwide [ ] [ ] [ ] , as well as on modelling possible regulatory frameworks [ , ] . however, nurses' engagement in multiple job-holding is, in comparison, less explored, despite preliminary evidence of its high prevalence in high-income [ ] as well as in lowincome settings [ ] , and amid concerns of its impact on the nurses' wellbeing [ ] . nurses and midwives are the world's largest group of health professionals, representing % of the global health workforce, and their role is widely considered critical for the delivery of uhc goals in high-as well as low-income countries [ ] . however, the profession has recently come under pressure because of growth of the demand for health services and concomitant scarcity of funds, and the global shifts in the world's health labour market [ ] . as the nursing workforce is predominately female, policy options to address nurses' participation in the public and private labour market will need to take gender into account [ , ] . this scoping review sets out to fill this knowledge gap by systematically searching and reviewing the studies conducted on nurses' simultaneous engagement in public and private clinical activities [ ] . its specific objectives are ( ) to map out the existing literature on the subject, determining its prevalence and distribution across geographies, publication types (e.g. peer-reviewed, grey), and specific topics addressed; ( ) summarise the evidence, perspectives, and specific contents addressed; and ( ) propose an agenda to advance research and development activities to first identify and then mitigate any pervasive effects of nurses' dual practices to uhc, based on the scoping review results. a scoping review was conducted to determine the extent and key themes within the literature on nurses' dual practice, as well as to identify areas for future research on the topic. such knowledge synthesis method is commonly used to address exploratory research questions, to map the existing literature on a field or to preliminarily identify gaps in that literature [ ] [ ] [ ] . we used the five arksey and o'malley's methodological steps to develop the research questions, identify relevant studies, include/ exclude articles, extract the data, and report the findings [ ] . as the methodological guidance for the report of scoping review is still under development, we used the prisma guidelines where appropriate [ ] . in march , we searched medline (through pubmed), the isi web of knowledge, scopus, and the cinhal plus with full texts (through ebsco). we used a set of keywords for the searches and, where appropriate, medical subject headings for nurses combined with keywords and indexed terms related to dual practice (using the bolean operator ' and'). additional file provides full details for the initial search strategy for each of the databases searched. the grey literature also was searched by visiting websites dedicated to nursing and/or health workforce issues. to widen the scope of the review, the searches on databases and grey literature were not filtered for publication date, language, or publication type. human resources for health experts (named in the additional file ) were a priori contacted to provide relevant references on forms of dual practices among nurses. a posteriori (early december ), and based on suggestions coming from the peer-review process, we expand the search terms in the database searches (adding the keywords 'temporary employment' and 'multiple employers') to provide a few additional records which were considered for the review results, as well. iterative rather than strictly streamlined procedures are typical in the process of conducting scoping reviews [ ] . a final search strategy included snowballing searches (reference list scanning, author tracking) performed on the articles preliminarily selected. references from databases or other sources were filtered through the same eligibility criteria. to be included, studies needed to address explicitly both nurses and dual practice issues. the working definition for the 'nurses' category contained explicit reference in the text to the professional label, with midwives included too. the working definition of dual practice, in turn, referred to concomitant practice in two (or more) distinct clinical services, either in the same or in different healthcare institutions. public employment was considered the primary job, whereas the secondary (or subsequent) job(s) was considered the one(s) where fewer working hours were spent, periodically or regularly. alternative labels for dual practice included 'moonlighting' , 'public-private work' , 'multiple profit-generating activities' , 'dual/multiple job-holding' , and 'second jobs'. 'casualization of work' , defined as the process of replacing full-time and regular part-time staff with contract staff employed on an ad hoc basis, is another phenomenon related in many ways to dual practice [ ] . as such, papers addressing this form of employment in relation to dual practice were also included. documents in english, french, portuguese, italian, and spanish were included. with the exception of journal commentaries, editorials, and letters to the editor, we did not exclude references because of the type of article (such as opinion pieces), study output (e.g. final or preliminary results), countries or world regions, publication status (i.e. both peer-reviewed and grey literature), or publication date. titles and abstracts were first screened by one of the authors (tj) and then reviewed in duplicate by the first author (gr), who finally determined the suitability for the full-text review. full-text review was carried out by one of three authors, all with a research track record in nurse workforce and/or dual practice issues (gr, if, jb). any of the authors were able to directly include or exclude papers on the basis of the eligibility criteria; agreement between two or more reviewers was sought for doubtful cases. based on the overarching aim of the paper, the preliminary knowledge of the literature, and a priori consultation with health professionals [ ] , we developed the following set of questions to guide the data extraction for the review: what are the forms in which nurses engage in multiple profit-generating activities? what are the different features of nurses' multiple job-holding? what is the prevalence of this phenomenon in nursing? why do nurses engage in dual practice? what are the enablers and barriers for nurses' dual practice? what are the personal/ professional drivers and consequences? what are the consequences for health systems, specifically for the delivery of quality and safe nursing/health care? what are the consequences for nurses' welfare? what are the consequences for patients? what are health workers', managers', and patients' perceptions around this practice? data extraction tables were then purposively built by the research team to collect data on the specific questions above, either using textual data or synthesis of the articles' findings/conclusions. consistent with the scoping review methodology, the data extraction did not involve quality appraisal or grading of the evidence from the studies. a conventional form of qualitative content analysis, with coding categories derived directly from the text data, was used to analyse data retrieved for each topic [ ] . the first author performed a first synthesis of the extracted material, that was then iteratively edited by two of the other authors (if, jb) following the themes from the data extraction table. from records retrieved, ( %) were excluded after reviewing their titles and abstracts (fig. ). an additional four articles were identified through snowballing search strategies, resulting in a total of full texts assessed for eligibility. of all these, a total of ( %) articles finally met the inclusion criteria for addressing dual practices of nurses: using predominantly quantitative methods and using mostly qualitative designs. the vast majority of the studies were in english, with only four published in portuguese and one in spanish. additional file provides spreadsheets for the (a) list of included articles organised by study-type, (b) the data extraction table, and (c) list of articles excluded with the respective reasons. the vast majority of such documents ( %) were peerreviewed publications, with the remainder being nursing magazine publications ( %), reports, and doctoral dissertations. twenty publications focused on high-income countries (particularly on the usa, uk, canada, and australia), on low-and middle-income ones (south africa, ethiopia, iran, and uganda), and two provided a global view on the phenomenon. many of the documents (n = ) reported information on the prevalence of the phenomenon, and discussed its different forms ( ) . drivers and motivations of nurses' multiple job-holding were the subject of (out of ) of the documents, while individual and institutional consequences of the practice were discussed in and pieces, respectively. only seven of the retrieved documents mentioned policy options associated with nurses' multiple-job holding. below we present the literature retrieved, organised in sections reflecting the emerging themes. from the documents retrieved, it emerged that nurses' engagement in dual practice can take different forms and shapes, with often blurred boundaries. some authors mention 'secondary jobs' and 'moonlighting' practices, where public sector nurses engage with the private sector either individually or through an organised nursing services agency [ ] [ ] [ ] . ribera silva et al. ( ) as well as gupta et al. ( ) refer generally to 'nurses taking up public or private secondary jobs' in brazil, chad, côte d'ivoire, zimbabwe, and mozambique. a similar operational definition is adopted by serra et al. to describe nurses' practicing simultaneously in the national healthcare system and for ngos or private clinics. publications from hics at times use the expression 'casualization of work' to describe job insecurity through a lack of a stable contract of employment, but also the practice of working flexibly for public and private health facilities, often through agencies and banks for outsourced nursing services [ ] [ ] [ ] [ ] . however, a distinction is drawn in the literature between holding multiple jobs concurrently, and dual practice, where the nurse's primary job is in the public sector, and that may be affected in many forms by the simultaneous engagement with other clinical, profitgenerating activities [ ] . three common forms of nurses' dual practice are mentioned, and often used interchangeably, in the literature; primary public sector employment with additional nursing work in the public sector-typically nightly extra shifts in different departments of the same hospital/facility, or other public facilities in the same geographical area [ , ] ; primary public sector employment with additional nursing work in the formal or informal private sector-long-hours shifts, or side jobs during spare time/vacation from main employment [ , , ] ; fixed part-time employment in the public, coupled with multiple flexible contract assignments in public and private sector, often though nurse agencies (referred to as 'casualization') [ , , ] . some authors report that boundaries between public and private sector employment are often blurred, particularly in low-income settings, and that ad hoc classifications of multiple-job holding may be required to capture the essence of the practice for specific countries [ ] . although using different definitions of the practice, a number of studies attempted measuring the prevalence of nurses' engagement in multiple job-holding in highincome as well as low-and middle-income countries (see table below). these are mainly cross-sectional surveys that do not provide data on trends for the phenomenon. for australia, creegan et al. [ ] show that . % of nurses worked part-time in , while in batch and windsor found that the nursing profession had a higher rate of casualization than other professional and highly skilled workforces, and that . % of nurses were employed in non-standard work [ ] . for the uk, tailby reports that % (of ) nurses registered with nhs nurse banks had another nursing job, and % worked occasionally or regularly additional shifts paid at bank or agency rates [ ] . in a survey among nursing magazines' readers in [ ] , % declared taking up extra nursing work, and % another full time job outside nursing; years later, % of the nurses participating in another online magazine readers survey declared engaging in bank and/or agency shifts [ ] . a report from the us bureau of labor statistics [ ] shows that multiple job-holding has grown steadily over the last decades, that . % of nurses had multiple jobs in , and that such prevalence was higher for a small sample of male nurses ( . %). a article from canada [ ] provides evidence that . % of all rural nurses are in casual jobs and that casualization is particularly common among registered nurses and licenced practical nurses ( . %), and more common among those nurses living in the north of the country ( . %). evidence on the phenomenon from lmics is substantial too; gupta et al. report from a multi-country study that nurses dual practice would be more limited than physicians'-the former calculated to be % in chad; % in cote d'ivoire; % in jamaica; % in mozambique; % in sri lanka; and % in zimbabwe [ ] . in a world bank study in ethiopia [ ] , a similar proportion of a cohort of public sector nurses ( %) were found to have secondary jobs years after their initial appointment. several studies by rispel and colleagues from south africa showed the prevalence of different forms of multiple employment to be common (around %) and on the rise among south african nurses [ , ] . and in brazil, portela et al. showed . % of nurses in two public hospitals to be moonlighters [ ] . a few individual and institutional drivers for the practice are recurrent in the literature. at a personal level, the need to increase overall earnings by supplementing income from main salary is by far the most common, such as in northern ireland and elsewhere in the uk-where holding multiple jobs is seen by many nurses as an essential way to increase income [ , ] . however, also for a low-income country like ethiopia where a nurse's salary is typically higher than the country's average gross domestic product (gdp) per capita, serra et al. report that half of the nurses followed in their study took up a second job to support their families [ ] . flexibility of additional part-time employment seems to be another key factor for australian and uk nurses, since nursing is a typically female profession, and some female workers have a strong preference for part-time, flexible jobs in comparison to their male peers [ , ] . in the surveys in south africa [ , ] , the opportunity for learning new nursing skills, the need to introduce diversity in professional routines, a more stimulating working environment, the quality of supervision, and the ability to select their own working hours were the key reported motivating factors for south african nurses. at a more institutional level, also in south africa, the growing demand for nursing services from the private sector is pointed to as the key driver of the phenomenon of casualization of nursing employment. taking a broader organisational perspective, batch and windsor ( ) argue that the 'casualization movement' is really aimed at creating a more flexible, cheaper, and easier to manage the nursing workforce. no specific study appears to have assessed the impact of nurses' dual practice, although many articles offered hypotheses and interpretations in regard. generally, health worker's dual practice is regarded unfavourably in the academic literature. mcpake et al. argue that, depending on its forms and prevalence, it could hamper the attainment of uhc in some countries [ ] . others report that the associated increased tiredness and lack of alertness for casual workers who work long hours in multiple jobs, as well as their difficulty of communication with resident staff, are reported to substantially increase the risk of clinical accidents [ ] . however, a phd dissertation work from the usa shows that, on average, nurses with a secondary job tend to work fewer hours in their primary, public employment than their non-moonlighting colleagues [ ] . studies in south africa suggest that moonlighters are also more likely to take vacation and time out from their main employment to pursue other jobs [ ] , and intentions to leave economic-higher rate for single day fees than in home country of n ireland the public sector and/or migrate have been found to be more frequent among them than in their single-job peers [ ] . baumann et al. argue that employing an unbalanced proportion of full-time and casual nurses reduces flexibility of a hospital management, as these latter would be less available to cover for unforeseen needs [ ] . in the case of ontario, canada's experience with the severe acute respiratory syndrome (sars) epidemic, such factors, together with the increased dependence of many hospitals in high-income countries on agency nurses, have been suggested could compromise the system's 'surge capacity' , that is, its ability to rapidly scale-up services and response in the face of epidemics [ ] . in a qualitative study in rural community hospitals in canada about the changing nature of nursing work, montour et al. argue that employment in multiple organisations contributes to scheduling issues because casual nurses are unavailable to fill vacant shifts [ ] . and finally, according to some studies, some types of health workers' dual practice can critically undermine health service provision and public trust, as it often entails conflict of interest, idleness, and absenteeism [ ] . at a more personal level, portela et al. show that taking extra shifts can seriously affect nurses' general health and exhaustion levels, with night shifts reported to be less disruptive than day ones [ ] . such findings on sleeping patterns are also echoed by ribeiro-silva et al. [ ] for hospital nurses in rio de janeiro, brazil, and by knauth for workers outside the clinical profession [ ] . casualization of work was also identified as a major source of career fatigue and burnout in qualitative interviews with nurses in australia [ ] . marginalisation and exclusion of part-timers by their peers was also reported to be a major source of dissatisfaction and frustration in an ethnographic study on australian nurses [ ] . as a positive individual consequence, nurses were reported to value highly the opportunity dual work offers to complement meagre public salaries in high-income countries [ ] and to support extended families in lowincome ones [ ] ; in the usa in , nurses earned more in their secondary job than in their primary employment [ ] . flexible working hours is another characteristics that nurses would find particularly attractive in secondary, casual jobs in the uk [ ] . in this respect, creegan et al. suggest that flexible working arrangements would be particularly suited for the predominantly female nursing workforce [ ] . only a minority of the studies retrieved in this review (eight) present and discuss possible policy options for managing, regulating, or controlling the practice. mcpake et al. [ ] link the choice of policy measures to the prevalence of the practice and to the country's regulatory capacity. rispel et al. [ ] highlight managing moonlighters as a key human resource for health strategy in south africa; consultation with frontline nurses to counteract the practice's negative impact is suggested as a possible policy option. electronic time recording, cessation of unpaid overtime, and controls over the number of shifts are put forward as alternative measures by other authors [ ] , while developing clinical guidelines for hospitals to ensure safety of services 'in the hands of strangers' has been called for as a possible institutional measure. other scholars have argued for the need for a better understanding of dual practice patterns, in recognition of the fact that more effective planning and management of a flexible workforce could represent a more suitable solution than prohibition [ ] . our review revealed that nurses engage in multiple jobholding activities, with varying forms and prevalence in high-income as well as in low-income countries. the practice appears to be driven by multiple, complex, and varying factors beyond the obvious economic motif, and to have non-trivial consequences, particularly for nurses' welfare, organisation of health services, and health labour market. despite its prevalence and relevance, a surprising paucity of studies was found on nurses' dual practice, and very few policy options have been outlined in the literature to address the phenomenon. although in the nursing profession holding simultaneously multiple jobs cannot be necessarily considered as dual practice, the two areas often overlap, in shapes of poorly demarcated contours. consistently with what is observed for other professions, more than one way seems to exist for nurses to engage with dual practice, both in regulated and informal, casual fashions. this may at least in part explain why the practice has been under-reported and little regulated through the years, with some of its forms driven underground or even considered illegal in some countries [ ] , and other forms-such as the 'casualization' of nursing services-only recently having come to the fore in the context of rapidly evolving health labour markets [ ] . this absence of usable datasets would call for primary research to be conducted to, first, explore through qualitative research the specificities of the phenomenon and, second, to measure them quantitatively. unsurprisingly, our review of the available evidence appears to show that economic considerations are not the sole driver for nurses taking on simultaneous multiple jobs [ , ] . a basic dissatisfaction with the limited range of duties performed in their main job, limited opportunities for development, or availability of time made possible by night shift arrangements, are other important factors that may help explain such a decision. although much effort has been devoted in the past to understanding nurses' burnout [ , ] , surprisingly little attention has been given to the tendency to take on additional work in presence of an already heavy workload. in contrast to the comparatively better understood physician dual practice, the limited evidence reviewed suggests that nurses' dual practice is more likely to be bounded by the very nature of their jobs than it is for physicians, as typically nurses have limited autonomy and tend to work as part of a team, rather than as individual providers. on this basis, a hypothesis could be made that, while nurses are more likely to be part of an established team in their main (public sector) job, second jobs are often taken up as individuals, as agency nurses for one shift, or private home care visits. nurses' personal characteristics also appear to shape forms and extent of the practice in any one country. since taking up additional work in the private sector may be financially rewarding, but will also add to overall workload and may not necessarily increase career prospects, younger and comparatively lower paid nurses seem to be the ones likely to engage more in the practice [ , ] . as a compounding factor, as nurses are predominantly female and often perform a disproportionate share of child-rearing and care for elderly or disabled relatives' duties, we may speculate that having dependents will likely decrease their ability to take up additional hours, unless the additional income generated can compensate for any additional child care costs. the evidence available suggests that the consequences of this phenomenon are not negligible, particularly for the health of those nurses ending up working longer hours and hospital shifts because of their multiple commitments [ , ] , but also for the organisation of public and private health services facing a more 'casual' and less-committed kind of workforce [ ] . interestingly, the most recent literature on nursing and midwifery enterprises [ , ] recognises this limitation and may lay the grounds for a different type of engagement of nursing staff with private sector activities. we also did not find any evidence regarding the importance of economic considerations of nurses' dual practice, or of any difference between higher and lower income countries; as we suspect the implications of such practice may have substantial repercussions on the health labour market, this could represent an area of future research. this paper is based on a scoping exercise and so has limitations. the limited and often incomplete evidence made it difficult to be certain if dual practice is a factor of relevance in all health systems worldwide, if it is a major issue for nurse labour market participation, and its overall impact on the provision of care. with respect to the latter, this may be because some aspects of dual practice are on the margins of 'formal' work and may go unrecognised by formal systems of employment and regulation. all of the above call for a deeper understanding of the phenomenon, with the objective of better harnessing the changing nurses' workforce worldwide. following our review, the core elements of the required research agenda on nurse dual practice appear to be three-fold. first, further research is needed to systematically explore the nature, extent, and impact of nurse dual practice in different systems and countries; this can be achieved through the analysis of employment and professional register/association data sets where these exist, or by adhoc surveys of nurses and/ or workplaces. analysis of specific data sets in some countries (e.g. such as the current population census [ ] and the integrated public use microdata series the united sates; labour force surveys; and professional registries) may provide more evidence on prevalence of dual practice and some of its main forms. secondly, there is a need for developing a more informed picture of the reasons why nurses take on dual practice, their experiences and preferences of dual practice, and the impact on their broader work/life balance. this can be achieved through a qualitative approach, exploring multiple contexts in high-and low-income settings, and different nursing profiles. finally, there is a gap of research that establish the impact of dual practice at the policy level-what is its impact on participation rates, overall nursing hours available in different systems, what are the trends in incidence, what is the impact on nurses, and on the quality of care that is being delivered. measures could be needed to mitigate the effects of nurses' dual practice to protect the provision of free-of-charge public sector for vulnerable populations. this latter area for policy research is the most complex and challenging to interrogate, but also of potentially great significance. without a better understanding of nurse dual practice, it will continue to be a largely 'hidden' element in nursing workforce policy and practice, with an unknown level of significance, and an unclear impact on the delivery of care. priorities for research into human resources for health in low-and middle-income 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challenges advancing the application of systems thinking in health: exploring dual practice and its management in kampala, uganda. health research policy and systems / biomed central the nature and health system consequences of casualisation, agency nursing and moonlighting in south africa stress symptoms in female nurses working in emergency rooms no funding was received for this research. all the data and information included in this review can be found in the annexes. authors' contributions gr elaborated the original idea for the study. gr, if, and jb designed the study. tsj designed the methodology for the review. gr drafted the manuscript. all authors revised, read, and approved the final manuscript.ethics approval and consent to participate n/a. the authors declare that they have no competing interests.• we accept pre-submission inquiries • our selector tool helps you to find the most relevant journal submit your next manuscript to biomed central and we will help you at every step: key: cord- - z qrq authors: ehrlich, rodney; spiegel, jerry m.; adu, prince; yassi, annalee title: current guidelines for protecting health workers from occupational tuberculosis are necessary, but not sufficient: towards a comprehensive occupational health approach date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: z qrq health workers globally are at elevated occupational risk of tuberculosis infection and disease. while a raft of guidelines have been published over the past years on infection prevention and control (ipc) in healthcare, studies in different settings continue to show inadequate implementation and persistence of risk. the aim of this commentary is to argue, based on the literature and our own research, that a comprehensive occupational health approach is an essential complement to ipc guidelines. such an approach includes a health system framework focusing on upstream or mediating components, such as a statutory regulation, leadership, an information system, and staff trained in protective disciplines. within the classical prevention framework, primary prevention needs to be complemented by occupational health services (secondary prevention) and worker’s compensation (tertiary prevention). a worker-centric approach recognises the ethical implications of screening health workers, as well as the stigma perceived by those diagnosed with tuberculosis. it also provides for the voiced experience of health workers and their participation in decision-making. we argue that such a comprehensive approach will contribute to both the prevention of occupational tuberculosis and to the ability of a health system to withstand other crises of infectious hazards to its workforce. high rates of tuberculosis (tb) in the populations of low-and middle-income countries (lmics) are associated with high rates of latent tb infection (ltbi) and tb disease in health workers [ ] [ ] [ ] . the most recent systematic review reports a pooled incidence rate ratio for active tb disease among health workers of . , and a pooled odds ratio for ltbi of . , relative to control populations [ ] . in high-hiv-burden countries, hiv infection among health workers [ ] sharply increases their risk of tb, while the rise in drug-resistant tb has further intensified the threat associated with the disease [ , ] . there is no shortage of prevention guidelines directed at healthcare settings where a tb hazard to staff and patients exists. international popularisation of the tb infection prevention and control (ipc) triad of administrative, environmental, and respiratory protection controls can be dated to the publication of guidelines in by the u.s. centers for disease control and prevention (cdc) [ ] . the guidelines, updated in , constituted a response to a resurgence of tb in the united states and nosocomial transmission in u.s. hospitals in the wake of the hiv epidemic [ ] [ ] [ ] . in parallel, the world health organization (who) has published a series of guidelines for low-resource settings [ ] [ ] [ ] , as well as several supporting documents on the implementation of ipc [ , ] and provision of healthcare and related services for affected health workers [ ] . ipc in healthcare settings has featured in other international responses. after considerable advocacy effort, including a statement by the international commission for occupational health (icoh) [ ] , the united nations (un) general assembly political declaration of recognised healthcare workers as an occupational group at risk from tb, and called for ipc and tb screening and surveillance for this population [ ] . while the core ipc guidelines were based on public health "first principles", systematic reviews have concluded that evidence of the effectiveness of various protective measures is limited and/or of "low quality" [ , , ] . the inability to provide data conforming to that produced, for example, in drug trials, arises from the practical and ethical difficulty of undertaking randomised controlled trials for prevention in this context. however, as argued in this commentary, successful preventive practices require an enabling system. an omnibus approach to the ipc package has emerged, reflecting the complex nature of such interventions [ , , ] . usefully, recent guidelines, have employed the grading of recommendations, assessment, development and evaluation (grade) rating framework for public health and clinical recommendations which includes other sources of information and judgements-specifically, a balance of benefits and disadvantages, values and preferences, and resource requirements [ , ] . this enables "low quality" evidence on effect size to contribute to a "moderate" or "strong" recommendation if the other criteria are favourable. this approach thus incorporates contextual factors and uses an optimisation approach to applying evidence. however, the need for an approach that goes beyond ipc guidelines is suggested by the growing number of studies across the world that consistently reveal poor or inadequate implementation of tb ipc [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . barriers to ipc implementation vary with the study design and questions asked, but cover the whole gamut: lack of a national regulatory framework and associated budget; lack of management support; unfamiliarity of staff with ipc guidelines; failure to triage or screen patients; insufficient infrastructure and equipment, such as isolation spaces and personal protective equipment (ppe); deficient ventilation; inadequate staffing and training; poor functioning of infection control committees; and neglect of exposed non-clinical staff. qualitative studies, which have a greater capacity to probe health workers' experience, reveal a perception among health workers of a disproportionate focus on individual-level personal protections, particularly n respirators [ ] ; an experience of powerlessness [ ] ; habituation to tb risk or a sense of fatalism [ ] ; and difficulty in understanding patients and securing patient cooperation with ipc [ , , ] . the objectives of this piece are to argue for a comprehensive occupational health approach to the problem of tb in health workers, and to reflect on what such an approach adds to the prospects for improved prevention and practice. we draw on research carried out by our group as occupational health professionals and researchers in recent years [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] , plus the experience of two of the authors (r.e. and a.y.) as clinicians and policy advisors to healthcare facilities, as well as provincial and national public sector health departments in south africa and canada, respectively. we argue that a comprehensive approach should conceive of the problem of protecting health workers within the widest possible framework, including legal and ethical considerations, should be multilevel and cross-disciplinary, and should be informed by the experiences of health workers themselves. a schema for making this argument is given in table . each domain is dealt with in the sections that follow. table . components of a comprehensive occupational health approach to the protection of health workers from occupational tuberculosis (tb). primary (control of tb transmission in healthcare settings), secondary (tb screening, early diagnosis of health workers, and effective treatment), and tertiary (rehabilitation, jobs, and social security). health systems framework assessing and strengthening the capacity of the health system to deliver quality healthcare to the whole population, including its own workforce, across all medical conditions, and to respond to crises. law and ethics understanding and use of statutory legal instruments, as well as the management of ethical implications of practices to protect health workers from tb. health worker voice and advocacy extent to which opportunities are provided for the views and experiences of health workers to be raised to influence the organisation of healthcare. figure applies the framework of primary, secondary, and tertiary prevention to consider opportunities for protecting health workers from occupational tb. it directs attention to the number of ways in which health workers can be at risk and protected from tb, and is an antidote to exclusive focus on any one level. a strong health system is both an enabler and a consequence of prevention activities, as discussed further in the next section. table . components of a comprehensive occupational health approach to the protection of health workers from occupational tuberculosis (tb). primary (control of tb transmission in healthcare settings), secondary (tb screening, early diagnosis of health workers, and effective treatment), and tertiary (rehabilitation, jobs, and social security). assessing and strengthening the capacity of the health system to deliver quality healthcare to the whole population, including its own workforce, across all medical conditions, and to respond to crises. understanding and use of statutory legal instruments, as well as the management of ethical implications of practices to protect health workers from tb. extent to which opportunities are provided for the views and experiences of health workers to be raised to influence the organisation of healthcare. figure applies the framework of primary, secondary, and tertiary prevention to consider opportunities for protecting health workers from occupational tb. it directs attention to the number of ways in which health workers can be at risk and protected from tb, and is an antidote to exclusive focus on any one level. a strong health system is both an enabler and a consequence of prevention activities, as discussed further in the next section. primary prevention in the form of ipc receives the lion's share of attention in guidelines, and remains the foundation for protection. however, secondary prevention contributes to primary prevention by aiming to keep health workers unimpaired and non-infectious in their daily work. this includes occupational health services to provide screening for active tb and the management of affected health workers [ ] . an occupational health platform would also be needed for any programme to screen for and treat ltbi. ltbi screening has long been recommended in low-tbincidence countries, such as the united states [ , ] , and appears in the latest who guideline as a (conditional) recommendation for low-tb-incidence countries only [ ] . consensus on what is required and feasible in high-tb-incidence, lmic settings is elusive. while there are many studies of primary prevention in the form of ipc receives the lion's share of attention in guidelines, and remains the foundation for protection. however, secondary prevention contributes to primary prevention by aiming to keep health workers unimpaired and non-infectious in their daily work. this includes occupational health services to provide screening for active tb and the management of affected health workers [ ] . an occupational health platform would also be needed for any programme to screen for and treat ltbi. ltbi screening has long been recommended in low-tb-incidence countries, such as the united states [ , ] , and appears in the latest who guideline as a (conditional) recommendation for low-tb-incidence countries only [ ] . consensus on what is required and feasible in high-tb-incidence, lmic settings is elusive. while there are many studies of ltbi prevalence in these settings, programme implementation research in this area is scarce and is a pressing need. tertiary prevention, by ensuring that health workers with an occupational disease have access to medical care and special sick leave, and to rehabilitation or to supported retirement, should be regarded as a basic labour right and is discussed further in section . although not explicitly presented in figure , hiv-infected health workers need to be considered within this framework as a particularly vulnerable sub-population needing protection. in south africa, estimates of the proportion of health workers infected with hiv are of the order of % [ ] . hiv infection dramatically increases the risk of progression from tb infection to disease [ ] . a programme of voluntary hiv testing, followed by treatment and counselling on job placement, should thus be regarded as part of primary prevention of tb in affected settings. vaccination of health workers against tb also falls into the category of primary prevention. bacille calmette-guerin (bcg) vaccination or revaccination of health workers is not currently a recommendation by either the cdc [ ] or who, and variation in health worker bcg vaccination practice across europe reflects the lack of consensus as to its efficacy [ ] . however, vaccination should remain on the agenda of a comprehensive occupational health approach-for example, revaccination of ltbi-negative health workers or testing and rollout among health workers of one of the new vaccines on the horizon [ , ] . using a health system framework involves a shift in perspective towards one that is cross-cutting and systemic, political as well as technical. it draws attention to the governance and organisation of healthcare that enable disease control and clinical programmes and practices, and which are geared to achieving greater equitability and sustainability in health outcomes. health system assessment and strengthening are conceptualized by who as focused on the performance of six inter-related building blocks: governance and leadership, information, health financing, health workforce, services, and technology [ ] . this is a two-way interaction. adequate performance in respect of all the building blocks is required if ipc and workplace tb prevention programmes are to work, as discussed further below. conversely, investment in protecting health workers from occupational infectious disease has the potential to yield system-wide benefits. these include tb surveillance as an indicator of respiratory disease risk in healthcare settings; "cross-silo" cooperation in the healthcare system; reduced absenteeism and improved staff retention and morale; and greater patient safety, quality of care, and trust in the health system [ ] [ ] [ ] , ] . at their most upstream, structural health system barriers encompass international and national political economy. an example particularly relevant to africa is the imposition on governments of structural adjustment programmes by international lenders that require reducing the size of the public sector, thereby decreasing healthcare expenditures-including on the control of tb [ ] . zelnick [ ] studied the struggles among south african nurses to provide care and protect themselves against bloodborne exposure in the early days of the hiv/aids epidemic. among the causes of this situation, the author identifies the failure of the new south african government, under the pressure of neoliberal macroeconomic policies, to devote sufficient resources to district health facilities, resulting in staff shortages and a hazardous work environment over which nurses felt they had no control. more recently, lispel and fonn have illuminated the relatively unexplored subject of corruption in the health sector, particularly the diversion of health funding through rigged tendering and supply activities, combined with the enabling factor of poor governance [ ] . a little more downstream, we recently used the who health systems framework from an occupational health perspective to explore the perceptions of key informants within the south african health system of barriers to protection of health workers from tb [ ] . such barriers include, inter alia, lack of an information system to produce the necessary intelligence on health and safety; fragmentation of governance across different organisational units within jurisdictions and health facilities; difficulty in maintaining technological components, such as germicidal ultraviolet light air disinfection; and lack of occupational health services trusted by staff. remedying the deficits outlined above involves costs in the form of organisational management, staffing, clinical practice, ancillary services, and procurement. cost within fixed administrative budgets is, however, a major cross-cutting barrier [ , ] . this creates hesitancy among senior health service managers to commit significant resources to occupational health and safety amidst competing priorities, even if the actions are legally mandated, and especially if they believe tb in their staff is not an occupational disease [ , ] . this suggests that a useful starting point for collaboration between occupational health and ipc is an information system able to track and investigate active tb in health workers for the purposes of risk assessment and targeted ipc. an example is the occupational health and safety information system (ohasis), developed through a collaboration of occupational health and ipc professionals at the university of british columbia with the national institute for occupational health in south africa, and applied in the national health laboratory service of south africa [ , ] . those applying generic guidelines need to consider the legal and related institutional environment of their jurisdictions, and whether this environment is sufficiently enabling. in many and perhaps most countries, occupational health and safety is governed by statutory regulation, which provides a framework of requirements and standards, as well as an enforcement mechanism to prevent occupational injuries and disease [ ] . a review across botswana, zambia, and south africa of laws relevant to reduction of tb transmission adopted a systems view by focusing on regulations governing national legal and policy frameworks; facility design, construction, and use; patients' and health workers' rights; and research, as well as the monitoring of infection control measures and tb surveillance among health workers. the authors concluded that the laws and regulations provided a "strong foundation" for these activities [ ] . however, in high-tb-burden countries, particularly in public sector facilities, the competing demands on the healthcare budget may be used as an alibi for the failure to provide sufficient resources to protect staff from tb [ , ] . there may also be resistance to the application of an "industrial" model of regulation, inspection, and enforcement to the healthcare sector. the notion of voluntary acceptance of risk, an old common law defence by employers against liability for occupational injury or disease, and one that has long formed part of the vocational ethos of healthcare, contributes to this resistance [ , ] . legislation by itself is thus no guarantee of adequate preventive practice in healthcare-as indicated, for example, by the number of studies on poor implementation of tb ipc in south africa [ , , , , ] . worker's compensation or broader social security are components of tertiary prevention of occupational tb. as with preventive legislation, practice varies. in south africa, tb suffered by a health worker who has had contact with tb patients is presumed to be occupational. in contrast, in mozambique, tb is not recognised by statute as an occupational disease, an omission identified by local health workers as a major barrier to comprehensive management of occupational tb [ ] . worker's compensation does not cover students unless they are regarded as employee trainees. students, however, are also at risk of workplace tb [ ] . high annual tb infection rates (i.e., new infections) of / person years have been recorded in medical students in johannesburg using the tuberculin skin test (tst) [ ] , and . / person years in nursing students in zimbabwe [ ] . community health workers are another category of health worker who may be vulnerable to weak benefits or protections in their employer-employee relationship and thus lack proper social protection [ , ] . outside of statutory protection, there are ethical considerations applicable to secondary prevention and occupational health generally. two areas of impact are stigma and screening. there is now a large body of literature confirming that stigma looms large in health worker attitudes to tb preventive practices, including unwillingness to self-disclose tb disease or participate in employer provided services where confidentiality is of concern [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the reduction of stigma requires an understanding of its context-specific nature and cultural content, e.g., in south africa, where tuberculosis has a strong association with hiv infection [ ] . however, the need for protection of the privacy of affected workers is in tension with the social need for self-disclosure to serve accurate risk assessment and to protect and educate co-workers. a contrasting strategy used in south africa by a network of health workers affected by tb has been to publicise their status and share their personal experiences as an educational and a mobilising strategy [ , ] . screening programmes, particularly in low-resource settings, need to pay attention to the ethical implications of medically examining workers who have not presented themselves to healthcare professionals. such considerations have long been part of medical surveillance in occupational health practice, and a body of ethical and legally sensitive guidelines have been developed [ ] . these address issues of informed consent and refusal of consent, the reliability of the test, confidentiality, and third-party reporting of results to employers, all of which require an agreed protocol in advance of screening. historically in some countries, labour unions have played an important role in securing recognition of the tb risk to health workers and related action [ ] . this has included efforts to include a labour perspective in early cdc deliberations on preventive guidelines [ ] . however, it is difficult to make a general statement about the current state of labour union involvement globally in the protection of health workers against tb. in south africa, advocacy by health workers themselves has emerged as a prominent voice for health worker rights in the form of tb proof, a voluntary group that includes a number of members who have suffered from tb [ ] . their work is augmented by a network of concerned health workers internationally [ , ] . tb proof activities have a several elements that we believe should be emulated elsewhere. these include engagement with national policy-making on tb; maintaining a website with educative and activist materials; a strong focus on destigmatising tb; the targeting of students and junior healthcare staff to protect themselves, but also to assert their right to be protected; and the effective use of personal narratives and media [ ] . the voice of health workers has found a place in the large number of publications using qualitative research-typically key informant but also arts-based methods-and covering all aspects of occupational tb risk and management [ , , , , , , [ ] [ ] [ ] ] . some of this work throws light on unrecognised deficiencies in health care practice, such as the exposure of community health workers to infective risk [ ] or the failure of patients to accept or understand ipc owing to cultural or language barriers [ ] . guidelines aimed at standardising operational practice to prevent occupational tb are essential. however, implementation takes place in a local setting, characterised by its own legal framework and employee rights regimen, resourcing, co-morbidity (such as hiv), and cultural attitudes. as greenhalgh and papoutsi have argued, the complexity lies in the interaction between an intervention and the pre-existing organisation of health care, and not necessarily in the intervention on its own [ ] . for example, barriers to implementation can be lowered by intensified training of health workers [ , ] , but the argument here is that such training is insufficient for sustainability if the necessary systemic scaffolding is not in place. the experience of two of the authors (a.y. and j.s.) in an occupational health/ipc programme, developed over almost years in one of south africa's poorer provinces, illustrates the value of customized interventions, including new policies and staffing, at the individual, facility, and provincial and national government levels [ , ] . a common approach to improving implementation is auditing, using operational checklists as a basis for expected quality improvement [ , ] . however, what we propose here is that the concept of a checklist be expanded to include the widest perspective possible. it should cover questions such as whether the system includes primary, secondary, and tertiary levels of protection, as well as embracing a health system framework such as the ones we have described here; whether there is explicit commitment of senior leadership to health system strengthening via ipc and occupational health and safety; whether the legal and ethical implications in relation to screening, coverage, and other thorny aspects referred to earlier are being dealt with; and whether channels for worker voice and agency exist and are used. while not easy to achieve, particularly in high-tb-burden, low-resource settings, policies and practices that incorporate this approach are more likely to provide for long-term sustainable protection of the essential human resources needed to fight tb and indeed other infectious hazards at work. this commentary was prepared before the covid- crisis. while there are many differences between tuberculosis and covid, the approach outlined provided a guide in the early phases of the local covid epidemic in south africa. over and above the urgent pressures of ipc, a systems approach has enabled recognition of the need for collaboration across disciplines and organisational units, occupational health coverage of all levels of the health system, a rapid-response information system on health worker infection and attrition, and a properly functioning worker's compensation regimen. as the covid pandemic develops, it is likely that many of the elements identified in this commentary will require closer attention. what has been striking in the scramble worldwide to put the necessary protective systems in place is the vulnerability of health workers even in high-income countries. however, the longer view must be taken. robust systems designed to protect health workers from infectious hazards, whether viral epidemics or tb, are needed as a continuing rather than as a reactive project, to better withstand the further threats to come. this includes making use of the crisis to embed properly functioning occupational health and ipc practices as an essential part of a resilient health system. latent tuberculosis 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cohen, alan b. title: living in a covid‐ world date: - - journal: milbank q doi: . / - . sha: doc_id: cord_uid: csy fekx nan politicians and scientists over control of the narrative. misinformation abounds regarding the virus, its origins, preventive measures to contain it, and the prospects for cures and vaccines. equally damaging is the false dichotomy that permeates the public debate over whether it is more important to restore the economy or mitigate the pandemic. the enormous political and economic pressure to "re-open" the country to commerce and "normal" activity has caused virtually all states to relax "stay-at-home" orders and other restrictions intended to control the virus' spread. however, public health experts remain concerned that these activities may generate new surges in the numbers of confirmed cases, hospitalizations, and deaths. there is no denying that we now live in a covid- world-one fraught with constant uncertainty about personal safety as well as our collective health and economic well-being. those affected the most by the pandemic-low-income individuals and communities of color-also are the most disadvantaged by poverty and other social determinants of health. as we begin to chart a path toward recovery, we need to recognize the interconnection between health equity and economic security. economic recovery in the absence of an equitable health care system will only perpetuate longstanding historical injustices. however, a reformed health care system that truly embraces and pursues equity in health outcomes will serve the needs of all americans and instill hope in the future. this transformation will take time, effort, and resources, and it will test the patience and resolve of many as they adapt to living in a covid- world. what, then, might this journal do in the present situation? throughout its history, the milbank memorial fund has been dedicated to connecting leaders with the best available evidence and experience. in that same spirit, the quarterly has been committed to applying the best empirical research to practical policymaking regarding population health. we intend to pursue that goal in the current crisis, publishing original research and insightful perspectives that advance knowledge in the field and serve the public interest. this month, we will announce a call for papers regarding policies and practices as they relate to the covid- pandemic, with an eye toward improving future decisionmaking and avoiding the mistakes and pitfalls of the recent past. stay tuned-details to follow. this issue of the quarterly contains a mix of articles, some targeted to the covid- pandemic and others spanning our ongoing areas of editorial interest. in "detailing the primary care imperative"-the third installment in our milbank classics series-james perrin celebrates the enduring wisdom of barbara starfield, leiyu shi, and james macinko in their landmark article, "contribution of primary care to health systems and health." perrin emphasizes the important characteristics of primary care-first contact care, holistic person-focused care over time, comprehensive care, and coordinated care-that emerged from this work and have become ingrained within primary care medical homes across the nation. he critically examines the progress made by the united states in the years since the publication, citing notable improvements but also pointing out the lingering weaknesses and obstacles to fulfillment of starfield's original vision for primary care. in two complementary milbank quarterly perspectives, nason maani and sandro galea explore the long-term negative effects of the united states' failure to invest in the nation's infrastructure to address both population health and public health. in "covid- and underinvestment in the health of the us population," they identify the underlying conditions of the us population that have made americans particularly susceptible to the spread of the virus, including inequitable socioeconomic conditions, long-entrenched racial and ethnic divides, poor treatment of marginalized populations, and a mismatch between health care needs and access to care. in "covid- and underinvestment in the public health infrastructure of the united states," the authors examine trends in public health funding, noting the chronic underfunding of state public health departments and reductions in federal funding of public health in favor of commitments to build hospital infrastructure and support biomedical research. these trends, they assert, have hampered the nation's ability to respond appropriately to the covid- crisis. to counter these problems, they call for a sustained federal commitment for a centrally coordinated and accountable public health infrastructure coupled with acknowledgment by policymakers that social determinants are the foundational causes of health and that the health of all citizens is a public good that can lead to economic security. as states look for novel ways to provide affordable health insurance to their citizens, several are implementing initiatives that test the concept of a "public option" to compete with private insurance within the affordable care act marketplaces. in a new milbank quarterly perspective, michael sparer evaluates reform efforts in two states: washington state, which enacted a "public option," and new mexico, which failed in its effort to enact a medicaid buy-in. sparer compares the two approaches, finding that federal funding remains central to expanded coverage and that the line between the aca public expansion and the commercial marketplaces has become blurred, posing significant challenges to state policymakers. he contends that washington state's initiative will be important to follow as a redefined "public option" that potentially might serve as a politically viable model for health reform. the democratic presidential election campaign stirred contentious debate over potential health reform-pitting single payer medicare for all plans against incremental changes to the affordable care act. with joe biden as the presumptive democratic nominee, the likely path for democrats will be modest and incremental. in a new milbank quarterly perspective, tsung-mei cheng draws upon the work of her late husband and health policy collaborator, uwe reinhardt, with particular attention to possible lessons for the united states from germany's all-payer health care system. the perspective is a tribute to the legacy of reinhardt, who for more than four decades illuminated the fields of health economics and health policy with his penetrating insight and witty commentary that always offered object lessons for policymakers and researchers alike. in a sweeping review, cheng defines allpayer systems and their advantages, compares health care spending in the united states with that in several other nations, provides a detailed description of germany's all-payer system, and concludes with lessons for the united states. both she and reinhardt believe that germany's system could serve as a model to help bend the cost growth curve and expand coverage, while also creating a kinder health care system for all americans. in an original research article, that also is the subject of a milbank quarterly in conversation podcast this month (see https://www.milbank. org/quarterly/milbank-quarterly-podcast/), emilie courtin and colleagues address the question of "can social policies improve health? a systematic review and meta-analysis of randomized trials." their comprehensive review and meta-analysis of these experiments in the united states find suggestive evidence of health benefits associated with investments in early life, income support, and health insurance policies. however, many of the studies are underpowered to detect health impacts and are at risk of bias. they recommend that future social policy experiments be better designed to measure and evaluate health outcomes. how to prioritize interventions with intertwined threats and costs poses great challenges for decision makers in large urban counties. in "which priorities for health and well-being stand out after accounting for tangled threats and costs? simulating potential intervention portfolios in large urban counties," bobby milstein and jack homer use county health rankings data for a predefined peer group of urban counties to identify cross-impacts among threats to health and wellbeing. adding appropriate time delays, they develop a dynamic model of these cross-impacts and simulate each of the counties over years to assess the likely impact of potential interventions for outcomes that include years of potential life lost, the fraction of adults in fair-poor health, and total spending on urgent services. the combined portfolio of interventions yields improvements by year that are considerably greater than those at year . poverty reduction and social support are the most highly ranked interventions. they suggest that a significant concentration of resources in a regional portfolio ought to go toward these strongest contributors for equitable health and well-being. in a rapidly changing health care environment, primary care leaders need training to enhance their practice-level leadership skills. in "leading innovative practice: leadership attributes in leap practices," benjamin crabtree and colleagues review the literature on leadership from the perspective of complex adaptive systems, and identify nine leadership attributes thought to support practice change. they apply these attributes to practices that rank high on a practice learning and leadership scale from the learning from effective ambulatory practice (leap) project to see whether and how the attributes manifest in highperforming innovative practices. all nine attributes identified from the literature are evident and seem important during a time of change and innovation. the authors argue that complexity science offers a hypothesized developmental model in which some attributes are foundational and necessary for the emergence of others. policymakers need to evaluate integrated care programs to identify and manage conflicts and tensions between a program's aims and the context in which it operates. in "rethinking integrated care: a systematic hermeneutic review of the literature on integrated care strategies and concepts," gemma hughes and colleagues report on a systematic review of literature covering integrated care strategies and concepts. their analysis includes comparing heterogeneous strategies and concepts, developing a taxonomy of the literature, and generating a new interpretation of those strategies. common across empirical and conceptual work is a concern with unity in the face of fragmentation. however, the authors find that integrated care programs do not necessarily lead to intended changes in experiences and outcomes, which they attribute, in part, to significant misalignment between the aspiration for unity underpinning conceptual models on the one hand and the multiplicity of practical application of strategies to integrate care on the other. they conclude that models of integrated care need to be valued for their heuristic rather than predictive powers. community-engaged research (cenr) aims to engender meaningful academic-community partnerships to increase research quality and impact, and to improve individual and community health through the uptake of evidence-based practices. in "measuring community-engaged research contexts, processes, and outcomes: a mapping review," tana luger and colleagues describe a mapping review aimed toward helping partnerships find and select measures to evaluate cenr projects and characterize areas where further development of measures is needed. the authors identify multiple measures of context (factors to support effective academic-community collaboration), process (measures of group dynamics and trust), and outcomes (impacts such as benefits and challenges of cenr participation). they find substantial variation in how academic-community partnerships conceptualize and define even similar domains. they advocate a hybrid approach in which partnerships discuss common metrics and develop locally important measures to address cenr's multiple goals. the flint, michigan, water crisis-a manmade tragedy that exposed thousands of children and adults to excessive lead levels in the city's drinking water-has been well documented. a major factor explaining why the crisis unfolded as it did is the complexity of the laws regulating how government agencies maintain and monitor safe drinking water. peter jacobson and colleagues analyze "the role of the legal system in the flint water crisis" by examining the legal arrangements governing public health and safe drinking water, and the degree of legal preparedness among governmental officials. their analysis reveals flaws in both the legal structure and the implementation of the laws that failed to stop the crisis while simultaneously exacerbating it substantially. they recommend that policymakers examine the legal framework in their jurisdictions and take appropriate steps to avoid similar disasters. precision medicine depends on new technologies that measure specific biomarkers, which theoretically will lead to more accurate diagnosis and targeted treatment. owing to the disruptive nature of these technologies, they often require radical changes to clinical practice and service organization. in "personalized medicine, disruptive innovation, and 'trailblazer' guidelines: case study and theorization of an unsuccessful change effort," alex rushforth and trisha greenhalgh describe a case study of an attempt by academic researchers to radically change asthma management in the united kingdom using a precision medicine biomarker. the authors employ a wide-ranging data set that includes documents, interviews, and ethnographic observation. they find that, despite efforts by the academic researchers to engage in clinical guideline development for primary care clinicians, practitioners working outside tertiary referral centers do not accept the vision of precision medicine as inscribed in the guideline for various reasons. they believe that "trailblazer" guidelines, based on new, disruptive technologies, may catalyze practice change only in a limited way for interested individuals and groups, and that, in the absence of broader professionally led change efforts, may be strongly resisted. in closing, we wish to inform readers that scholarly opinions will no longer appear in the print edition of the quarterly. all opinions will appear exclusively on our website (https://www.milbank.org/quarterly/ the-milbank-quarterly-opinions/). we invite you to visit the website, where you will find recent opinions by contributing writers lawrence gostin, sara rosenbaum, and joshua sharfstein as well as guest opinions by sherry glied and others on various topics of interest. he could have seen what was coming: behind trump's failure on the virus lives were lost' as warnings went unheeded, whistleblower tells house centers for disease control and prevention. coronavirus disease : cases in the u.s covid- forecasts the employment situation million americans now unemployed as another million file for benefits. the guardian the u.s. was beset by denial and dysfunction as the coronavirus raged trump's aggressive advocacy of malaria drug for treating coronavirus divides medical community trump abandoned it -and science -in the face of covid- during coronavirus pandemic, governors' leadership is critical. the philadelphia inquirer states relax coronavirus restrictions as u.s. fitfully seeks steps toward normalcy covid- and racial/ethnic disparities key: cord- -pfo oup authors: riley, william t; borja, susan e; hooper, monica webb; lei, ming; spotts, erica l; phillips, john r w; gordon, joshua a; hodes, richard j; lauer, michael s; schwetz, tara a; perez-stable, eliseo title: national institutes of health social and behavioral research in response to the sars-cov pandemic date: - - journal: transl behav med doi: . /tbm/ibaa sha: doc_id: cord_uid: pfo oup the covid- pandemic has been mitigated primarily using social and behavioral intervention strategies, and these strategies have social and economic impacts, as well as potential downstream health impacts that require further study. digital and community-based interventions are being increasingly relied upon to address these health impacts and bridge the gap in health care access despite insufficient research of these interventions as a replacement for, not an adjunct to, in-person clinical care. as sars-cov- testing expands, research on encouraging uptake and appropriate interpretation of these test results is needed. all of these issues are disproportionately impacting underserved, vulnerable, and health disparities populations. this commentary describes the various initiatives of the national institutes of health to address these social, behavioral, economic, and health disparities impacts of the pandemic, the findings from which can improve our response to the current pandemic and prepare us better for future infectious disease outbreaks. to combat the covid- pandemic, populationlevel social and behavioral strategies to communicate risk and encourage behaviors to mitigate transmission risk have been rapidly implemented. given the urgent public health need to reduce the transmission rate as quickly as possible, rigorous safety and efficacy research (including cost-benefit studies) of these various social and behavioral mitigation strategies could not be conducted prior to widespread implementation. research on the use of these strategies during prior influenza [ , ] and coronavirus [ ] epidemics provides some empirical guidance for implementation, but the transmission profile of the sars-cov virus and the extensive implementation of these mitigation strategies limits the generalizability of prior findings to the current pandemic. as a result, we are living through a global social and behavioral intervention experiment to mitigate the transmission of sars-cov . there is an urgent research need to improve our understanding of how well these strategies mitigate transmission risk, how different communities are impacted by these mitigation strategies, and the potential secondary effects of these mitigation strategies on health and welfare. the pandemic has exacerbated existing health disparities, not only with regard to immediate infection risk but also long-term health inequities that increase the risks of covid- complications and death [ ] . african americans, latinos, and other racial/ethnic minorities are disproportionately more likely to work in essential public-facing jobs that cannot be performed remotely and live in more densely populated urban areas, increasing the risk of exposure to the virus [ ] . many service workers who have lost their jobs as the businesses that employ them have closed or scaled back operations, as well as their families and communities, are weathering serious financial strain. job loss also is associated with the loss of health insurance and commentary/position paper implications practice: digital and community-based interventions are being relied upon increasingly to bridge the health care access gap resulting from the covid- pandemic, some with inadequate support as a replacement for, not as an adjunct to, in-person clinical care. policy: mitigation strategies have benefits and costs, including potential downstream health effects, particularly for underserved and vulnerable populations, that need to be evaluated as these strategies are being implemented. research: the national institutes of health has developed a range of behavioral and social science research initiatives to address the evaluation of covid- mitigation strategies, their economic, social, and health impacts, interventions to bridge health care access disruptions, and the uptake and interpretation of virus testing, particularly in vulnerable and underserved communities. reduced health care access [ ] . as a result, the downstream health effects of these economic factors are likely to confer a disproportionate impact on those already experiencing health disparities. the extensive economic and social disruptions from these mitigation strategies [ ] highlight the need to evaluate both the benefits and costs of these approaches and their potential differential impact on communities. while some research has identified a relationship of economic downturns and unemployment on health, including substance abuse [ ] , mental health conditions [ ] , and suicide [ ] , the relationship of economic downturns to overall health and mortality is complex. some studies have shown that economic downturns are associated with improved health and reduced mortality depending on how confounds are controlled [ ] . public health response to the covid- pandemic and to future illness outbreaks can be improved with more precise parameters for modeling the impacts of social and behavioral changes, including the economic impact on mortality and morbidity related to the acute public health crisis [ , ] . during the pandemic, health care resources have been diverted to address covid- , "elective" services have been postponed, and most patients and providers are not participating in face-to-face care. concomitantly, there may be a surge in the need for these services as some conditions, such as substance abuse, mental illness, and chronic conditions, may be exacerbated by the stress of the pandemic, inadequate access to medications, the public health mitigation strategies, and/or their economic repercussions. where possible, digital health and telehealth technologies have been used increasingly to provide services remotely [ , ] . although there is considerable research on these digital interventions, many were intended as adjuncts to in-person treatments, not as a replacement for in-person care. increasing reliance on telehealth and other digital interventions also may exacerbate already existing health inequities given inequities in computer and broadband access [ ] . community-based interventions have been employed to provide needed health care access, particularly in vulnerable or underserved communities [ ] , but the ability of these digital and communitybased interventions to bridge the gap in adequate health care access, especially for underserved and vulnerable populations, requires further study. the long-term impact on those who recover from covid- is not yet known. psychosocial complications from intensive care units have been observed [ ] , and it is reasonable to hypothesize that the limitations on social contact and family support while hospitalized may exacerbate these complications. furthermore, some who recover may experience survivor guilt or stigma associated with having covid- , which may negatively impact psychosocial recovery. another pressing area of needed research is sars-cov testing uptake and response. the health belief model was born from the experiences with tuberculosis (tb) screening in the s in which, despite the convenience of mobile tb screening in communities, many did not get screened due to perceptions of the severity and susceptibility of being infected and of the benefits and barriers of testing [ ] . more recently, hiv testing uptake has been shown to be influenced by intrapersonal, interpersonal, and sociocultural factors [ ] . as the capacity of virus and antibody testing for sars-cov expands to test broadly throughout the population, not just among those with symptoms, the field will need to apply what we know about what motivates individuals to get tested and to interpret and respond to test findings appropriately, especially in vulnerable and underserved communities. structural factors that hinder testing (e.g., mistrust of science and racism) in these communities also need to be anticipated and addressed. in the near future, facilitating vaccination uptake, particularly given misinformation campaigns about vaccines being rapidly evaluated for safety and efficacy [ ] , will be an important research effort as well. national institutes of health (nih) responded to urgent research needs for testing, therapeutics, and vaccines, as well as the important social and behavioral research needs described above. the following describes the key behavioral and social science-related efforts of the nih covid- research response. data to facilitate social, behavioral, and economic research on covid- early in the pandemic, nih institutes, centers, and offices issued several calls for research using rapid funding mechanisms to communicate interest and priorities addressing research questions regarding mitigation effects, economic, and social impacts, downstream health effects, and the disproportionate effects in vulnerable and health disparities populations. notices of special interest (nosis) relevant to these social, behavioral, and economic research directions are listed on the office of behavioral and social science research funding opportunity page (https://obssr.od.nih.gov/research-support/fundingannouncements/). the response to these supplement nosis has been strong, and nih has developed an accelerated and coordinated review process to rapidly fund meritorious supplement applications. many of the nosis encourage the collection and capture of multilevel data prepandemic and postpandemic to assess mitigation strategies and their economic and health care side effects on health and welfare across the country, as well as cross-nationally. large nationally representative longitudinal samples, as well as smaller targeted samples capturing smaller vulnerable populations, can provide important insights about change over time of health and well-being, both short and long term, to inform current and future mitigation efforts. encouraging the use of comparable items or protocols when appropriate can increase the utility of collected data without limiting innovation. to encourage broad use of nih-supported data resources and research replication, nih issued a notice (https://grants.nih.gov/grants/guide/noticefiles/not-od- - .html) highlighting harmonization and data sharing expectations to investigators requesting support to collect data for covid- research. covid- and its mitigation require assessing unique constructs specific to the pandemic. the speed with which researchers developed and deployed covid- survey items made a priori harmonization impossible, but data integration and sharing can be facilitated by survey item sharing. nih is collecting covid- -specific items for population and clinical research and making them available to encourage future researchers to use these recently developed items to compare findings and facilitate data integration. two platforms, the disaster research response (dr ) and phenx have been used to submit, post, and share survey items used in population and clinical research. dr serves as a platform for full survey instruments (https://dr .nlm.nih.gov/). phenx provides distinct covid- item modules (https://www. phenxtoolkit.org/covid ) in addition to a wide array of non-covid- -specific measurement protocols, including recently added social determinants of health protocols. nearly covid- specific surveys have been posted to date, but the degree to which these survey items have been tested and validated is not yet available. future work will further organize, vet, and provide backend database functionality for these covid- -specific survey items. the initial supplemental appropriations from congress for nih covid- research (hr and hr with combined nih supplemental appropriations of $ . billion) targeted predominately vaccine and therapeutics development and evaluation. nih also established a public-private partnership called accelerating covid- therapeutic interventions and vaccines to accelerate this research in partnership with other government agencies, biopharmaceutical companies, and other entities [ ] . although these efforts are predominately biomedically focused, within the therapeutics clinical trials efforts, there has been considerable interest in the recovery process, including research on the psychosocial recovery of those who survive covid- illness. to adequately cover the wide-reaching areas of research related to covid- , trans-nih workgroups were formed by nih leadership. the social, behavioral, and economic impacts of covid- , particularly in vulnerable and health disparities populations workgroup has developed funding opportunities to implement and evaluate digital and community-based interventions to extend the health care workforce, bridge health care access limitations, and engage communities to understand and reduce the adverse impacts of the pandemic on the health of underserved and vulnerable populations (not-mh- - , https://grants.nih. gov/grants/guide/notice-files/not-mh- - . html; not-md- - , https://grants.nih.gov/ grants/guide/notice-files/not-md- - .html). digital health care intervention research is needed to determine the role and impact of digital health interventions (e.g., mobile health, telemedicine and telehealth, health information technology, wearable devices, and personalized medicine) during and following the covid- pandemic to ameliorate the secondary health impact. while digital health care interventions are a necessary approach during a disease outbreak, research is needed to ensure that they are robustly effective and can bridge the digital divide across the lifespan and economic status to reduce, not exacerbate, existing health care disparities. similarly, community intervention research is encouraged to implement and evaluate the impacts of mitigation strategies to prevent covid- transmission and acquisition in nih-designated health disparity populations and other vulnerable groups and to evaluate already implemented or new/adapted interventions to address the adverse psychosocial, behavioral, and economic consequences of the pandemic on the health of these groups. in addition to the supplement nosis listed above, nih recently released funding opportunity announcements on digital (https://grants.nih.gov/grants/guide/pa-files/par- - .html) and community (https://grants. nih.gov/grants/guide/pa-files/par- - .html) intervention research to address these research questions. the nih received a $ . billion supplemental appropriation from congress (hr ) to accelerate research on virus and antibody testing. this large initiative, called rapid acceleration of diagnostics (radx), focuses on a number of critical testing research needs [ ]. among the radx testing efforts is rapid acceleration of diagnostics-underserved populations (radx-up), a trans-nih initiative to increase access and uptake of covid- testing in underserved and vulnerable communities. the overall goal of radx-up is to reduce covid- -associated morbidity and mortality disparities for vulnerable and underserved populations that have been disproportionately affected by the pandemic as a result of higher infection rates and/or risk of more adverse outcomes from contracting the virus. the initiative will leverage existing research centers and networks with established community-engaged relationships and new collaborations among individual research awardees with the potential to mobilize quickly to have a positive impact on testing in underserved or vulnerable groups (not-od- - , https://grants. nih.gov/grants/guide/notice-files/not-od- - . html; not-od- - , https://grants.nih.gov/ grants/guide/notice-files/not-od- - .html). nih funds a wide range of large-scale, communityengaged research projects in underserved and vulnerable populations that are well positioned to address these research questions. the initiative will include research focused on the social, ethical, and behavioral implications of sars-cov testing in these populations (not-od- - , https://grants.nih.gov/grants/guide/notice-files/ not-od- - .html), as well as a coordination and data collection center as a national research resource (rfa-od- - , https://grants.nih.gov/ grants/guide/rfa-files/rfa-od- - .html). the radx-up initiatives not only will generate critical research findings to improve testing uptake and follow-up but also will provide the infrastructure for future community-based research on contact tracing, therapeutics, and vaccine uptake as well. the nih has developed a rapid and comprehensive research response to the sars-cov and covid- pandemic. in addition to critical biomedical research in testing, therapeutics, and vaccines, nih has also prioritized key social and behavioral research questions involving mitigation strategies, economic and social disruptions from those strategies, downstream health and health care impacts, interventions to ameliorate these downstream impacts, psychosocial recovery from covid- , and testing and vaccination uptake, especially in the populations disproportionately affected by the pandemic. research supported by nih has the potential to shape how we understand and prioritize our mitigation strategies and can inform how these strategies can best be reinstituted should a second wave of infections occur. evaluation of digital and community-based interventions deployed to address downstream health effects will improve the understanding of the effects of these interventions and their mechanisms. as testing is expanded, the research supported by radx-up will provide critically important information about how to encourage broad-based uptake of sars-cov testing, especially in underserved and vulnerable populations, and prepare us to encourage vaccine uptake when vaccines become available. nih is committed to the acceleration of research to diagnose, prevent, and treat covid- and the downstream health impact of this pandemic. the findings from this research are critically important, not only to the current pandemic but also to addressing the social and behavioral challenges postpandemic and preparing us to respond better to any future disease outbreaks. disease mitigation measures in the control of pandemic influenza strategies for mitigating an influenza pandemic physical interventions to interrupt or reduce the spread of respiratory viruses unconscious bias, racism, and trauma-informed policing: an address and message to the connecticut racial profiling prohibition project advisory board labor force statistics from the current population survey short-run effects of job loss on health conditions, health insurance, and health care utilization global economic effects of covid- unemployment and substance outcomes in the united states economic downturns and population mental health: research findings, gaps, challenges and priorities economic downturns and suicide mortality in the usa, - : observational study macroeconomic conditions, health, and mortality global dynamic interventions strategies for covid- collaborative group. dynamic interventions to control covid- pandemic: a multivariate prediction modelling study comparing worldwide countries estimating excess -year mortality associated with the covid- pandemic according to underlying conditions and age: a population-based cohort study digital mental health and covid- : using technology today to accelerate the curve on access and quality tomorrow the role of telehealth in reducing mental health burden from covid- . telemed e-health covid- and digital inequalities: reciprocal impacts and mitigation strategies community-based healthcare, including outreach and campaigns, in the context of the covid- pandemic post-icu symptoms, consequences, and follow-up: an integrative review historical origins of the health belief model factors associated with antiretroviral treatment uptake and adherence: a review. perspectives from australia, canada, and the united kingdom us anti-vaxxers aim to spread fear over future coronavirus vaccine. the guardian accelerating covid- therapeutic interventions and vaccines (activ): an unprecedented partnership for unprecedented times key: cord- -vclkuink authors: sokas, claire m.; berrigan, margaret t.; fligor, scott c.; fleishman, aaron j.; raven, kristin e.; rodrigue, james r. title: is social distancing keeping patients from the ed?() date: - - journal: am j emerg med doi: . /j.ajem. . . sha: doc_id: cord_uid: vclkuink nan in response to covid- , public health organizations issued recommendations to limit transmission. these recommendations include physical distancing, frequent hand hygiene, and use of personal protective equipment (ppe). , in conjunction with state-level mandated shelter-in-place orders and the closure of schools and non-essential businesses, daily life in the u.s. has changed dramatically. we sought to characterize perceptions of public health recommendations and explore the decision to seek medical care for common symptoms. we conducted a -question survey assessing attitudes and behaviors associated with public health recommendations. to understand the impact on individual medical decision making, we asked participants to describe their approach to care for common symptoms before and during the pandemic, classifying behaviors according to escalation of care: ) stay home and see if it gets better ("wait and see"); ) call my doctor; ) present to an emergency department (ed), urgent care (uc), or call . we recruited u.s. adults fluent in english in mid-april . the survey was administered via amazon mechanical turk. descriptive statistics were calculated. multivariable logistic regression was used to investigate for predictors of escalation or de-escalation of care. data were analyzed using stata version . respondents were included. mean age was . and most were white ( %), male ( %), medically insured ( %), college educated ( %), and without chronic health conditions ( %). all states were represented and most participants ( %) lived in area state with a stay-at-home order in place. the majority of patients followed centers for disease control recommendations for daily behaviors "often" or "all the time" (figure ). most participants followed recommendations to work from home ( %), go out only for essential errands ( %) wash hands frequently ( %) and practice social distancing ( %); only half wore a mask in public. more than half of participants were "very" or "extremely" concerned about their personal and family's health. about half ( . %) felt that is they contracted covid- , they would develop a severe illness and % believed they would be unable to recover. most participants agreed or strongly agreed the novel coronavirus affected their daily work, family, or social activities ( %), that it is important for the general public to follow recommendations of public health officials ( %), and the pandemic will be shorter if public health recommendations are followed ( %). medical decision making before and after the start of the covid- pandemic is visualized in figure . for all symptoms, there was an increase in "call your doctor" during the pandemic. however, fewer patients would present to an ed or uc for respiratory symptoms during the pandemic (chest pain:  %), while rates of evaluation for abdominal pain and arm/leg weakness remained consistent. multivariable logistic regression of predictors of de-escalation of care did not identify any predictors consistent across all four symptoms. males were more likely to de-escalate care for shortness of breath or weakness of an arm/leg (odds ratio ( at the onset of the covid- pandemic in april , u.s. adults adapted their behaviors in accordance with public health recommendations and believed these mandates would lessen the impact of the pandemic. participants reported changing how they would seek care for common symptoms, with an increase in "call my doctor" for all symptoms and a decrease in seeking emergency care for respiratory symptoms-despite covid- causing primarily respiratory symptoms. this highlights the increasing role of telemedicine during this crisis and the need to further investigate how patients seek medical care. reduced ed visits and hospital admissions for common diagnoses during the pandemic have been puzzling-our findings highlight the importance of understanding and addressing health-related worries to understand changes in behaviors. , fear and uncertainty are common. most participants worry about their own and their family's health, their ability to obtain medical care, and prolonged, severe illness if they contracted covid- . when people are concerned about their health, they are more likely to alter their behavior. although our survey cohort was young and relatively healthy, limiting generalizability, these results demonstrate the importance of investigating health-related worries when interpreting behaviors moving forward. in the weeks following the initiation of public health recommendations, public perceptions were overall favorable and participants reported adherence to mandates in the setting of worry about personal health and reluctance to seek emergency care for covid- -related symptoms. we must consider patient fears and uncertainties regarding covid- to better understand how patients seek medical care. this work has not been presented at a meeting. j o u r n a l p r e -p r o o f ?cdc_aa_refval=https% a% f% fwww.cdc.gov% fcoronavirus% f -ncov% fprepare% ftransmission.html. accessed advice for public amazon's mechanical turk: a new source of inexpensive, yet high-quality, data? delayed access or provision of care in italy resulting from fear of covid- reduced rate of hospital admissions for acs during covid- outbreak in northern italy the public's response to severe acute respiratory syndrome in toronto and the united states figure . adherence to harm-reduction strategies no financial support to disclose. key: cord- -wgdqu s authors: singh, meharban title: pediatrics in (st) century and beyond date: - - journal: indian j pediatr doi: . /s - - -z sha: doc_id: cord_uid: wgdqu s pediatrics is a dynamic discipline and there is awareness and hope for actualizing outstanding achievements in the field of child health in (st) century and beyond. improved lifestyle and quality of children’s health is likely to reduce the burden of adult diseases and enhance longevity because seeds of most adult diseases are sown in childhood. identification and decoding of human genome is expected to revolutionize the practice of pediatrics. the day is not far off when a patient will walk into doctor’s chamber with an electronic or digital health history on a cd or palmtop and a decoded genomic constitution. there will be reduced burden of genetic diseases because of selective abortions of “defective” fetuses and replacement of “bad” genes with “good” ones by genetic engineering. availability of totipotent stem cells and developments in transplant technology are likely to revolutionize the management of a variety of hematologic cancers and life-threatening genetic disorders. the possibility of producing flawless designer babies by advances in assisted reproductive technologies (arts) is likely to be mired by several ethical and legal issues. the availability of newer vaccines by recombinant technology for emerging infective and for non-infective lifestyle diseases is likely to improve survival and quality of life. there is going to be a greater focus on the “patient” having the disease rather than “disease” per se by practicing holistic pediatrics by effective utilization of alternative or complementary strategies for health care. due to advances in technology, pediatrics may get further dehumanized. a true healer cannot simply rely on technology; there must be a spiritual bond between the patient and the physician by exploiting the concept of psycho-neuro-immunology and body-mind interactions. in the years to come, physicians are likely to play “god” but medicine can’t achieve immortality because anything born must die in accordance with nature’s recycling blueprint. the medical science is likely to improve longevity but our goal should be to improve the quality of life. abstract pediatrics is a dynamic discipline and there is awareness and hope for actualizing outstanding achievements in the field of child health in st century and beyond. improved lifestyle and quality of children's health is likely to reduce the burden of adult diseases and enhance longevity because seeds of most adult diseases are sown in childhood. identification and decoding of human genome is expected to revolutionize the practice of pediatrics. the day is not far off when a patient will walk into doctor's chamber with an electronic or digital health history on a cd or palmtop and a decoded genomic constitution. there will be reduced burden of genetic diseases because of selective abortions of bdefective^fetuses and replacement of bbad^genes with bgood^ones by genetic engineering. availability of totipotent stem cells and developments in transplant technology are likely to revolutionize the management of a variety of hematologic cancers and life-threatening genetic disorders. the possibility of producing flawless designer babies by advances in assisted reproductive technologies (arts) is likely to be mired by several ethical and legal issues. the availability of newer vaccines by recombinant technology for emerging infective and for non-infective lifestyle diseases is likely to improve survival and quality of life. there is going to be a greater focus on the bpatient^having the disease rather than bdisease^per se by practicing holistic pediatrics by effective utilization of alternative or complementary strategies for health care. due to advances in technology, pediatrics may get further dehumanized. a true healer cannot simply rely on technology; there must be a spiritual bond between the patient introduction in order to improve human resource, children deserve high quality of healthcare at all social and ethnic levels without any discrimination [ ] . the futuristic model of pediatrics is likely to be greatly modified by technology boom with further erosion of doctor-parent/patient relationship [ ] . the day is not far off when a patient walks in the doctor's chamber with an electronic or digital health history on a cd or palmtop. he may be asked to walk through a screening device to decipher his genome and get baseline biochemical parameters. the child is likely to get a computer-based diagnosis with the help of apps-based algorithms and given a print out of the prescription. every disease and human behavior is genetically determined by human genome and epigenetics. the life events are predestined on the basis of genome, which is like a sophisticated horoscope or janampatri or bsubtle language of god^. identification and decoding of human genome is the greatest achievement of st century [ , ] . human genome project ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) has identified and sequenced , genes. around billion dna base pairs have been decoded by dna probes. the scientists have identified diseases, which are expressed through genes. on the basis of genome, we can plan personalized strategies for prevention, diagnosis and treatment of diseases with patient-specific or tailor-made drugs. human genome has highlighted one of the mysteries that % of human dna carries no instructions. nature can't be wasteful, it is unlikely to be bjunk dna^, and it seems to be the storehouse of untapped human mysteries and potential. it is possible to diagnose a large number of life-threatening or disabling genetic, chromosomal and developmental diseases in the fetus and offer bselective abortions^to ensure survival of bgenetically normal^human beings [ ] . it is likely to reduce the burden of disability so that resources are effectively utilized for improving quality of human life. when a genetically abnormal individual is born, it will be possible to replace bbad^genes by bgood^genes tagged to carrier viruses by state-of-the-art genetic engineering technology [ ] . the technology is already being used for correction of genetic abnormalities in children suffering from severe combined immunodeficiency syndrome (scid) due to adenosine deaminase deficiency (ada), duchenne muscular dystrophy (dmd), cystic fibrosis, hemophilia, familial hypercholesterolemia and some cancers. advances in genetic technologies have led to refinements of various assisted reproductive techniques (arts) and feasibility to produce bdesigner babies^. it is possible to produce clones of babies with identical genetic makeup by artificial twinning of an embryo or by a more complex technique of somatic cell nuclear transfer (scnt). the classical example of scnt is the production of dolly, the sheep, by scottish scientists. dolly was the exact replica of the bmother sheepŵ hose dna material of a somatic cell was transferred into the enucleated egg cell of another sheep in-vitro. the embryo was implanted into a surrogate mother and carried to term [ , ] . however, the newer arts have raised several ethical and legal issues. hematopoietic stem cell transplantation (hsct) by using multipotent hematopoietic stem cells derived from bone marrow, peripheral blood or umbilical cord blood shall be increasingly exploited for treatment of hematologic cancers, nonmalignant diseases like thalassemia, aplastic anemia, inborn errors of metabolism and autoimmune disorders [ , ] . the source of stem cells may be autologous (stored patient's own blood) or allogeneic, when stem cells are obtained from a compatible donor. in allogeneic stem cell therapy, risk of infection, mismatching, rejection and graft-versus-host disease (gvhd) is much higher. cord blood is a rich source of stem cells. a number of companies such as lifecell, babycell, cordlife, and stemade provide services for collection and cryopreservation of cord blood, which can be used for treatment of a number of life-threatening and lifestyle diseases in the donor, siblings and parents in later life. it is possible to repair a defective organ of the body by infusing totipotent natural or cloned stem cells [ ] . there will be increasing use of technology to assess, monitor and manage patients, with further depersonalization of pediatrics. the communication skills or bedside manners shall be increasingly replaced by technical interventions. the patients are likely to be increasingly fragmented into systems, organs, tissues, cells and dna. the age old symbol of physicians, the stethoscope, is likely to be replaced by digital stethoscope powered by iphone or android smart phone, hand-held ultrasound device, pulse oximeter and apps -based algorithms for making a diagnosis in the ambulatory clinic. dna and rrna probes are likely to be increasingly used for diagnosis of infective and genetic disorders [ , ] . it is envisaged that in due course of time, just a drop of blood will be enough to obtain values of most of the biochemical parameters. electronic devices in the form of a smart biometric bwrist watch^are in the pipeline to monitor vital signs, some biochemical parameters, hydration status and oxygen concentration. it is based on non-invasive pulse wave data collector using a modified applanation tonometry technique for recording real -time radial artery pulse waves. it can be used as a stand-alone device or paired with your iphone or android smart phone [ , ] . the work is in progress to develop sensors for assessing kidney functions and add-on displays for ekg and eeg. intelligent scales or cutting-edge wireless smart scales are being developed to monitor body weight, body mass index (bmi), body water, bone mass, and daily caloric intake. japan is in the forefront to develop smart loos or intelligent toilets to maintain effective bottom hygiene, assess certain body parameters and analyze body wastes. it is hoped that in the near future bgenometers^will be available to delineate the genomic characteristics of a person to predict personality and vulnerability to various diseases during the life span of a person, akin to an indian horoscope. raman spectroscopy is a quick, easy and non-invasive tool that can identify a large number of objects by virtue of their molecular size and dna characteristics. almost every material has its own raman pattern, based on how strongly its atoms are bonded [ ] . hand-held raman scanners are available which can be used for identification of drugs of abuse and explosives, diagnosis of cancer, identification of pathogens and allergens and estimation of blood components. three pillars, which are crucial for maintenance of sound health and good quality of life, include sound genetic constitution, safe environment, and intake of wholesome balanced food. food is indeed the breakthrough drug of the st century! almost y ago, hippocrates said, blet thy food be thy medicine and thy medicine be thy food^. there is a popular indian saying, bwhen diet is wrong, medicine is of no use. when diet is correct, there is no need for any medicine^. in order to tackle the widespread deficiencies of iodine, iron, zinc and vitamin a, food fortification or use of nutritional sprinklers are likely to become a reality in selected populations. protein hydro lysates and hypoallergenic foods shall be available for prevention and treatment of food allergies, which are emerging as public health problems in certain populations. the concept of functional foods is being increasingly exploited to prevent illness, promote health and improve quality of life. these foods have potentially positive effects on health beyond nutrition [ ] . they promote positive health and reduce the risk of diseases by virtue of phytonutrients, antioxidants, soluble and insoluble fiber, and probiotics [ ] . genetically modified (gm) foods are genetically engineered to produce changes in their dna for selective and mutation breeding. they are produced for better yield, resistance to pathogens and herbicides and for better nutrient profiles [ ] . most food modifications have primarily focused on cash crops like golden rice, bt cotton, and vegetable oils. but technology is not without travails. the safety of gm foods is controversial because their intake may be associated with greater risk of allergies, immune suppression, elaboration of toxins, emergence of antibiotic resistant super bugs and nutritional problems. the nutritional content of animal foods like milk, eggs, and meat can be improved by feeding the animal a diet rich in omega- fatty acids and docosahexaenoic acid (dha) [ ] . vaccines have accomplished near miracles in the fight against infections with virtual eradication of smallpox and polio from the world. however, the increasing number of vaccine shots is painful and frightening both to the children and their parents. a needleless pen-shaped device has been developed to deliver drugs and vaccines through painless supersonic waves. oral and mucosal vaccines are being developed against rotavirus, typhoid, flu, cholera, rsv, and measles. genes from bacteria and viruses are being inserted into the genetic makeup of fruits, vegetables and cereal grains to produce edible vaccines that are not destroyed by cooking or frying the food [ ] . there is hope that in the near future, antigen-primed or transgenic bananas, potatoes, tomatoes, lettuce, rice, wheat, soybeans and corn, shall be available as child-friendly vaccines [ , ] . each human being is unique by virtue of its dna. but in the modern system of medicine we prescribe the same medicine, in the same dose, through the same route and for the same duration for every patient, which is obviously too simplistic and naïve. x-ray crystallography can identify the atomic and molecular structure of a crystal and is being harnessed to discover and design new tailor-made or personalized drug molecules. pharmacogenomics is being used to produce specific drugs on the basis of genomic subgroups [ ] . it is possible to deliver the drug to the site of disease with the help of liposomes and carrier monoclonal antibodies. it is associated with decreased dosing, better efficacy, and reduced risk of adverse drug reactions. a number of natural biological response modifiers (brms) have been identified and are being exploited to control severe infections and certain malignant disorders [ ] . they include interferons, interleukins, tumor necrosis factor (tnf), colony stimulating factors (csf, g-csf, gm-csf), cytokines, imiquimod, and monoclonal antibodies. milstein and his co-workers have combined two types of immune cells to create hybrid clones of immune cells or hybridoma in order to produce specific antibodies for a wide range of targets [ ] . the availability of monoclonal antibodies has ignited the hope for prevention and treatment of life-threatening infections, for transport and delivery of drugs to the site of disease, destruction of cancer cells and identification of metastases with the help of radionuclide antibodies [ ] . efforts are being made to implant memory biochips, arrays of nano-polymer wires and develop other neurobionic interventions to take over the functions of damaged neurons. it has been shown that electrical stimulation of tongue with the help of a portable neuromodulator stimulator (pons) can facilitate the repair of damaged neurons. the chinese workers have produced progenitor cells from urine waste cells, which are useful for regeneration of neurons. it is feasible to produce cyborgs with superhuman capabilities like an iq of a genius, eyesight of an eagle and hearing of a bat. a large number of lasers are available for photodynamic and cosmetic dermatology for treatment of various disorders of pigmentation and birthmarks. they include carbon dioxide laser, q-switched lasers (ruby, nd:yag, and alexandrite), argon laser, pulse-dye and metal vapor lasers [ , ] . attempts are being made to produce artificial blood or blood substitute which is either hemoglobin-based or per fluorocarbon-based oxygen carriers [ ] . they are likely to serve the felt need of chronic shortage of blood and eliminate the risk of transmission of blood-borne diseases, immune suppression and other adverse effects of blood transfusion. the research workers at the massachusetts institute of technology (mit), cambridge, united states have identified doublestranded rna activated caspase oligomerisers (draco), which are credited with effective antiviral activity [ ] . they can serve as broad spectral antiviral agents for a variety of viral illnesses like dengue, flaviviruses, arenaviruses, h n influenza and rhinoviruses. imaging-guided interventions and keyhole or minimally invasive surgical procedures with fast recovery and minimal scarring have already become a reality [ ] . it is possible to replace each and every defective body organ by biological (human or animals like baboons and pigs) or synthetic spare parts like hearing aids, cochlear transplants, lenses, dentures, pace makers, heart valves, silicon implants, artificial joints and limbs. computer-aided surgical robots are being increasingly exploited to conduct routine and complex surgical procedures at a local site or a distant location. the robotic surgery is associated with advantages of smaller incision, greater precision, miniaturization, reduced blood loss, less pain and shorter duration of hospital stay. intelligent surgical knife (iknife) has been developed for bloodless incision and the vaporized smoke produced while cutting the tissues is analyzed by a mass spectrometer to diagnose malignancy real-time. a large number of electronically guided equipment like lasers, fiber optics, drills and staplers are being used to conduct surgical procedures more effectively and with greater safety. smart e-pants or electric underpants are available to prevent occurrence of bedsores in chronic and comatose patients. tele-or distant medicine has become a reality and canadian workers have made outstanding contributions in this venture [ , ] . it is possible to transfer the clinical case file through e-mail or clip stored in the cloud. imaging scans and electromagnetic waves from various body organs can be transmitted through a telephone line or an app. consultations can be sought globally at the touch of a button. teleconferences are being increasingly used for distant teaching. it is possible to provide global live coverage of complex surgical procedures through satellite [ ] . medicine is dynamic and pediatrics is far more dynamic with a rapid pace of developments to improve survival and quality of life. a large number of innovations have already become a reality or are likely to be introduced in the near future (table ) . lifestyle diseases and over nutrition among adolescents are emerging as public health problems because of intake of calorie-dense junk food, sedentary lifestyle and indulgence in excessive bscreen time^. obesity is associated with adverse health consequences such as syndrome x, adult-onset diabetes mellitus, hypertension and coronary artery disease. a large number of newer infective disorders like hiv, sars, bird flu, swine flu, zika, ebola, and multidrug resistant superbugs are causing serious health issues. following control of infective diseases by better public health interventions and immunizations, newer non-infective disorders like cancers, allergies, metabolic abnormalities, psychological and stress disorders, degenerative disorders like alzheimer's, and diseases due to pollutants, pesticides and toxins are assuming public health proportions. whenever man tries to improve survival and quality of life, nature tries to seek a balance by unleashing natural disasters. there is an ever-increasing scare of natural table list of future innovations and developments man has always strived to prolong life and cheat death but despite all the technological advances, medicine can never achieve immortality! nature is a huge recycling plant and birth-life-death-rebirth is in accordance with a pre-ordained celestial principle. nevertheless, scientists have made attempts to upload human neocortex through cloud with the help of brain-computer interfaces to achieve singularity and digital immortality. it is hoped that by , we will have new breed of computers who will have the ability to feel, perceive, interact and have artificial intelligence with the help of braincomputer interfaces [ ] . it sounds fictional but attempts are being made to use cryonics technology to preserve human organs or whole body for future resurrection by using cloning nanotechnology to bring it back to life when a cure is found for the disease that caused the death [ , ] . it appears man is trying to play god, but these attempts are most likely to prove futile. instead of prolonging human life, it is more important to improve the vitality of health and quality of life throughout the life span of a person. there is an increasing awareness that technology should not be allowed to further dehumanize medicine. there is a need to provide holistic care by focusing on the bpatient^having the disease and not on the bdisease^per se. the patients should be viewed in totality, and that too not in isolation but in context with the dynamics of ecology, family, friends, and society. instead of becoming passive recipients of drugs, patients and their parents, should become active participants in order to augment the process of healing. effective communication and showing due concern, compassion and empathy can energize the psycho-neuro-immunology axis of the patient. it is desirable that all approaches to healthcare should be exploited to provide healing. the alternative approaches to health care include ayurveda, unani, siddha, homeopathy (ayush), naturopathy, acupressure, acupuncture, reflexology, tai-chi, digong, reiki, yoga, meditation, visualization, magnetic therapy, gemology, aroma therapy, salt therapy, prayer and spiritual healing. in order to improve effective utilization of all complementary therapies, ministry of health, government of india has created a separate wing of indian system of medicine and homeopathy (ism and h) for effective utilization of herbal medicines and drugless therapies. our body is suffused with a cosmic life force energy field consisting of light, heat, sound, electric and magnetic waves emanating from various bchakras^. the bio field, which is called aura, halo or corona, extends beyond the skin and forms a protective sheath. there are seven chakras, which are located along the spine adjacent to various endocrine glands. they are linked with the body meridians, nadis, bhongan, and duct system. it is believed that life energy or prana flows into and out of our chakras. starting from base of the spine to the top of the head, the chakras include kundalini (coccyx), hara (sacral), solar plexus (navel), heart (midback), thyroid (base of throat), brow (third eye), and crown (sahasrara), which integrates all the chakras and is a source of astral energy (gold sun) or global consciousness or nonbeing. a healthy person, who has physical vitality, mental clarity, emotional, social and spiritual wellbeing, is likely to have bigger and brighter auras [ , ] . whenever, there is stress or dysfunction, whether physical, psychological, social or spiritual, the chakra energy field or halo is disturbed. human chakras can be scanned by various kirlian equipment like polycontrast interference photography (pip), digital aura scanning system (das), gas discharge visualization (gdv), medical thermal imaging (mti), resonant field imaging (rfi), and electro interstitial scanning (eis). when a chakra is found to be diseased or dysfunctional, it can be energized or activated with electric current, magnetic waves, healing touch, reiki and crystal healing. there is tremendous hope and scope for outstanding achievements in the field of medicine in st century. there will be a greater focus on public health interventions to improve social, community, and environmental factors to enhance survival and quality of life. healthy lifestyle and improvements in the health status and quality of life in children is associated with reduced burden of adult diseases because seeds of most adult diseases are sown in childhood. advances in clinical genetics are likely to revolutionize pediatrics. there will be no issue of survival of the fittest because everyone will survive. individuals born with defective genes will be managed by insertion of healthy cloned genes by further refinements in genetic engineering technology. molecular diagnostic tests are likely to be readily available with a possibility of having personalized or tailor-made medicines depending upon the genetic constitution of the patient. a number of newer vaccines for emerging infections are in the pipeline including realization of the revolutionary concept to produce vaccines for a large number of non-infective lifestyle diseases. the scientists are going to play bgod^to produce designer babies but it is unlikely to become a reality because of tremendous ethical and legal issues. future pediatrics will not merely focus on diseases but will pay attention to children and their parents to energize the psycho-neuro-immunology axis and provide holistic medicine by further refinements and exploitation of a variety of complementary and alternative approaches to promote health. medicine will become more patient-specific and less disease oriented. we shall be able to prolong life and ensure the quality of life worth living but we should not aim for immortality or resurrection of life. nature is a huge recycling plant and no body should try to arrest the divine process of birth-life-death-rebirth… however, there is a fond hope that in the next millennium, people are likely to have an iq of and live to an average age of y-but more importantly they are likely to have a good quality of life worth living. the next century of children's health care communication as a bridge to build a sound doctor-patient/parent relationship the human genome project implications of human genome project for pediatrics prenatal diagnosis and selective abortion: a challenge to practice and policy gene therapy: principles, practice, problems and prospects sheep cloned by nuclear transfer from a cultured cell line viable offspring derived from fetal and adult mammalian cells clinical applications of bloodderived and marrow-derived stem cells for non-malignant diseases hematopoietic stem cell transplantation: a global perspective multi-organ multi-lineage engraftment by a single bone marrow derived stem cell diagnostic applications of dna probes dna vaccines for non-infectious diseases: new treatments for tumour and allergy improved non-contact optimal sensor for detection of glucose concentration and indication of dehydration level wearable electronic devices monitor vital signs, activity level, and more single-pulse standoff raman detection of chemicals from m distance during daytime a new definition of functional foods by ffc: what makes the new definition unique? functional foods hlth dis functional foods: their role in disease prevention and health promotion european commission. a decade of eu-funded gmo research dietary enrichment of eggs with omega- fatty acids: a review new delhi: thieme medical and scientific publishers pvt ltd a spoonful of antigen edible vaccines genomics, personalized medicine, and pediatrics polysaccharide immunomodulators as therapeutic agents: structural aspects and biologic function continuous cultures of fused cells secreting antibody of predefined specificity strategies and challenges for the next generation of therapeutic antibodies photodynamic therapy in dermatology: recent developments lasers used in dermatology artificial blood broad-spectrum antiviral therapeutics robot-assisted surgery: the future is here telepediatrics in canada: an overview one hundred years of telemedicine: does this new technology have a place in pediatrics telemedicine and child health blessing or curse? nonpharmacological neurocognitive enhancement by bbrain engineering^ scientific justification of cryonics practice cryopreservation of organs by vitrification: perspectives and recent advances the human biofield and chakras: concepts and processes. moscow: xlibris corp the biofield hypothesis: its biophysical basis and role in medicine conflict of interest none.source of funding none. key: cord- -fzusgbww authors: newby, j.; o'moore, k.; tang, s.; christensen, h.; faasse, k. title: acute mental health responses during the covid- pandemic in australia date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: fzusgbww the acute and long-term mental health impacts of the covid- pandemic are unknown. the current study examined the acute mental health responses to the covid- pandemic in adult participants in australia, using an online survey administered during the peak of the outbreak in australia ( th march to th april ). self-report questionnaires examined covid- fears and behavioural responses to covid- , as well as the severity of psychological distress (depression, anxiety and stress), health anxiety, contamination fears, alcohol use, and physical activity. % of respondents reported that their mental health had worsened since the outbreak, one quarter ( . %) were very or extremely worried about contracting covid- , and half ( . %) were worried about family and friends contracting covid- . uncertainty, loneliness and financial worries ( %) were common. rates of elevated psychological distress were higher than expected, with %, %, and % of respondents reporting elevated depression, anxiety and stress levels respectively, and one in four reporting elevated health anxiety in the past week. participants with self-reported history of a mental health diagnosis had significantly higher distress, health anxiety, and covid- fears than those without a prior mental health diagnosis. demographic (e.g., non-binary or different gender identity; aboriginal and torres strait islander status), occupational (e.g., being a carer or stay at home parent), and psychological (e.g., perceived risk of contracting covid- ) factors were associated with distress. results revealed that precautionary behaviours (e.g., washing hands, using hand sanitiser, avoiding social events) were common, although in contrast to previous research, higher engagement in hygiene behaviours was associated with higher stress and anxiety levels. these results highlight the serious acute impact of covid- on the mental health of respondents, and the need for proactive, accessible digital mental health services to address these mental health needs, particularly for those most vulnerable, including people with prior history of mental health problems. longitudinal research is needed to explore long-term predictors of poor mental health from the covid- pandemic. levels in the current cohort. we also expected people with lived experience of prior mental health diagnoses would have higher rates of distress and would be vulnerable to poorer mental health during the current pandemic. finally, we predicted that engaging in precautionary hygiene behaviours would be associated with lower distress. status (including whether they had recently lost their job due to , the industry of their main job, and the frequency at which they had worked from home during the past week (not at all, a little, sometimes, most of the time, all of the time). participants were asked whether they had a chronic illness (yes, no, unsure, prefer not to say) , and completed a single-item measure assessing their self-rated heath (idler & benyamini, ) , with responses on a -point scale from poor to excellent. participants were asked whether they had ever been diagnosed with a mental health problem such as depression and anxiety (yes, no, unsure, prefer not to say) , and whether they were currently receiving treatment for a mental health problem including medications, counselling, or psychological therapy (yes, no, unsure, prefer not to say) . participants were asked to complete single item measures of i) how lonely they were feeling, ii) how worried they were about their financial situation, and iii) how uncertain they were feeling about the future, on a -point scale (not at all, a little, moderately, very, extremely). they were then asked to rate how the compulsion [ ] , and iv) a specific measure of behavioural responses to the pandemic based on our prior study [ ] , and past research investigating behavioural responses to pandemics [ , ] . finally, we assessed physical activity levels using the physical activity vital sign [ ] which assessed i) the number of days in the past week they engaged in moderate to strenuous activity, and ii) the average number of minutes they exercised at this level, and screened for hazardous alcohol use using the modified alcohol use disorders all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . https://doi.org/ . identification test ] . all questionnaire responses were anchored to the past week, except for the audit-c (past month), and the padua contamination subscale (general). the mental health and lifestyle questionnaires were administered in randomised in order to minimise responding biases. participants were asked about their own covid- status (i have caught unsure, or other (open text) ). they also indicated whether they were in self isolation (yes -i am in voluntary self-isolation, yes -i am in forced self-isolation, no). participants were also asked i) whether any of their family or friends had contracted no, unsure), and ii) how concerned or worried they were that their friends or family members would contract covid- (not at all, a little concerned, moderately concerned, very concerned, extremely concerned). participants were asked five questions relating to their perceived risk from, and worry about, covid- . the first question assessed how concerned or worried respondents were about catching covid- on a -point scale (not at all concerned, a little concerned, moderately concerned, very concerned, extremely concerned). they then rated how likely they thought it was that they would catch the virus on a visual analogue scale (vas) from (not at all likely) to (extremely likely). they were asked how much they thought they could do personally to protect themselves from catching the virus (perceived behavioural control), on a (couldn't do anything) to (could do a lot) visual analogue scale. perceived illness severity was assessed by asking respondents how severe they thought their symptoms would be if they did catch covid- (response options were: no symptoms, mild symptoms, moderate symptoms, severe symptoms, severe symptoms requiring hospitalisation, and severe symptoms leading to death). finally, participants were asked about how much information they had seen, read or heard about coronavirus (nothing at all, a little, a moderate amount, a lot). all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . https://doi.org/ . to assess social distancing, hygiene and buying behaviours, participants were asked whether they had engaged in a total of behaviours during the previous week (see table demographic characteristics of the sample are depicted in table . overall, the sample was mostly female ( %), identified as being caucasian ( %), mainly spoke english at home ( %), and ranged in age from to over . participants were from various states and territories of australia, with the majority living in the most populated states of new south wales, victoria or queensland. sixty five percent were working in a paid job, and approximately one third were carers (for children, or people with a disability, illness, or the elderly). respondents' self-rated health was measured on a scale from poor ( ) to excellent ( ), with a mean of . (sd = . ). the majority of participants rated their health as 'fair' ( . %), 'good' ( . %), or 'very good' ( . %); relatively few participants rated their health as 'poor' ( . %)' or 'excellent' ( . %). only eight participants ( . %) reported that they themselves currently have or have had . % were unsure, and . % suspected they had covid- . approximately . % reported their family or friends had caught covid- , and . % were unsure. almost half ( . %) reported being in voluntary self- isolation, . % reported being in 'forced self-isolation' and . % were not self-isolating. all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . level of concern and worry about the possibility of contracting covid- was moderate (m = . , sd = . , range - , where = not at all, = extremely concerned). a small proportion reported being 'not at all concerned' ( . %), % reported being 'a little' concerned, . % were 'moderately concerned ', . % were 'very concerned', and . % were 'extremely concerned' about contracting respondents' ratings of the perceived likelihood of contracting covid- was moderate (m = . , sd = . ; scale from to ). perceived behavioural control, or the belief that personal protective behaviours could help prevent infection, had a mean score of . (sd = . ). with regard to perceived severity of symptoms if they caught coronavirus, only . % of respondents indicated that they would experience no symptoms; with mild ( . %) and moderate ( . %) symptoms most commonly expected. however, one in three respondents perceived the illness severity to be high: with . % indicating they thought they would experience severe symptoms, severe symptoms requiring hospitalisation ( . %), or severe symptoms leading to death ( . %). in terms of the amount of information participants had been exposed to about the coronavirus in the past week, most participants ( %) reported having 'a lot' of exposure to information, . % reported a 'moderate amount', whereas very few reported a little ( . %) or no information at all ( . %). participants' overall level of concern and worry about friends and loved ones contracting covid- was moderate (m = . , sd = . , range - , where = not at all, = extremely concerned). a small proportion reported that they were 'not at all concerned' ( . %), . % reported being 'a little' concerned, . % were 'moderately concerned', . % were 'very concerned', and . % 'extremely concerned' about their friends or family members contracting covid- . the percentage of respondents who reported having engaged in a range of distancing and hygiene behaviours during the past week is presented in table . during the previous week, handwashing and social distancing (avoiding social events and gatherings) were the most common behaviours. all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. note. numbers represent n and proportion (%) in brackets. all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. more than three quarters of participants reported that their mental health had been worse since the outbreak, with . % selecting 'a little worse', and . % selecting 'a lot worse'. a small proportion reported improvements in their mental health since the outbreak ( . %) (see figure ) . a chi square analysis revealed that there was a significant difference in the impact of covid- on mental health for participants with and without a prior mental health diagnosis ( ( ) = . , p <. ), with . % of those with a prior mental health diagnosis saying their mental health had been 'a lot worse', relative to . % in the group without a mental health diagnosis. all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. table shows the proportion of participants who scored across the severity categories of the dass- subscales. only . % of respondents scored in the normal range for depression, . % in the normal range for anxiety, and . % for stress. in contrast, . %, . %, and . % fell in the mild to moderate range for depression, anxiety, and stress respectively, whereas . %, . %, and . % reported severe or extremely severe stress levels. on the whiteley- , . % scored in the range indicating elevated health anxiety. of the participants who had valid scores on the physical activity vital sign (n= ), . % met national guidelines for minutes of moderate to vigorous physical activity in the past week. on the audit-c brief screener for alcohol use, approximately . % showed hazardous drinking levels. hazardous drinking levels were defined as an audit-c score of or more for women and other genders, and or more for men [ , ] . all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . comparison between people with and without prior mental health diagnosis people with and without a self-reported history of mental health diagnosis were compared in their severity of covid- fears, mental health, distress, health anxiety, alcohol use, contamination fears, and physical activity. people with a previous self-reported mental health diagnosis reported higher uncertainty, loneliness, financial worries, covid- fears (self and others), believed they were more likely to contract had lower perceived behavioural control, had higher rates of psychological distress, health anxiety and contamination fears, and lower physical activity than those without a self-reported mental health diagnosis history. there were no differences in alcohol use between these groups (see table ). was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. impact of self-isolation: compared to people who were not in self isolation, people who self-reported being in self-isolation reported higher uncertainty, loneliness, financial worries, and covid- fears (self and others), rated the symptoms of covid- as more serious, but believed they were less likely to contract covid- , and perceived more behavioural control over covid- . they also had higher rates of psychological distress, health anxiety and contamination fears, and lower alcohol use than those not in isolation. there were no differences in physical activity between these groups (see table ). was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . separate linear regression analyses were conducted to explore the demographic, occupational, and psychological predictors of dass- depression, anxiety and stress severity (see final model in table ). we entered demographic predictor variables (gender, age, occupational status, education, aboriginal and/or torres strait islander and carer status) in the first step. in the second step, we entered general health variables including chronic illness, mental health diagnosis history, and self-rated health. in the third step, we entered uncertainty about the future, loneliness, worry about finances. in the final step, we added covid- variables (whether they were in self-isolation, hygiene behaviours, exposure to covid- information, risk perceptions including perceived likelihood, perceived control, and severity of illness, concern/worry about contracting covid- , and concern/worry about loved ones contracting depression. demographic variables accounted for . % of the variance (r change = . , se= . , f change ( , ), = . , p <. ). entering the mental health diagnosis, chronic illness, and self-rated health variables accounted for . % of additional variance (r change = . , se= . , f change ( , ), = . , p <. ). in the third step, entering mental health variables accounted for . % unique variance (r all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . change = . , se= . , f change ( , ), = . , p <. ). finally, the covid- variables accounted for . % unique variance (r change = . , se= . , f change ( , ), = . , p <. ). the final model is presented in table and accounted for . % of the variance in depression scores. controlling for the other variables in the model, being female, more well educated, older, and having better self-rated health were all associated with lower depression, whereas being unemployed, a student, retired, carer or stay at home parent were associated with higher depression. mental health and chronic illness diagnoses were associated with higher depression, as were increased uncertainty about the future, loneliness, and financial worries. of the covid- variables, higher worry about covid- and perceived behavioural control over covid- infection were associated with lower depression, whereas perceiving higher illness severity was associated with higher depression. anxiety. in the first step, demographic variables accounted for . % of the variance in anxiety scores ( controlling for other variables in the model, being female, non-binary or different gender identity, and being aboriginal and/or torres strait islander were predictors of higher anxiety. older age, and more well educated (certificate, degree or higher) were predictors of lower anxiety. in contrast to depression, only being a student predicted worse anxiety. having a chronic illness, and prior history of mental health diagnosis were associated with higher anxiety, whereas better self-rated health was a predictor of lower anxiety. similar to depression, increased uncertainty about the future, loneliness, and financial worries were also associated with higher anxiety. of the covid- variables, more hygiene behaviours, worry about covid- , worry about loved ones contracting covid- , and higher perceived illness severity were all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . predictors of higher anxiety, whereas increased exposure to covid- information, and perceived control over stress. in the first step, demographic variables accounted for . % of the variance in anxiety scores (r change = . , se= . , f change ( , ) controlling for other variables in the model, identifying as non-binary or different gender identity, aboriginal and/or torres strait islander, predicted higher stress. being more well-educated with a trade certificate, and older age, were predictors of lower stress. being a stay at home parent was a predictor of higher stress. having a chronic illness, and prior history of mental health diagnosis were associated with higher stress, whereas better self-rated health was a predictor of lower stress. increased uncertainty about the future, loneliness, and financial worries were also associated with higher stress. of the covid- variables, more hygiene behaviours, worry about loved ones contracting covid- , and higher perceived likelihood of contacting covid were predictors of higher stress. higher perceived control over covid- predicted lower stress. all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . this survey presents the first insight into how the covid- pandemic has impacted the mental health of people living in australia, in a sample of individuals. rapidly disseminating an online survey enabled us to assess a large number of participants during the peak of the pandemic in australia to identify fears and acute distress and identify the relationship between demographic and psychological predictors of mental health. while very few individuals reported that they ( . %) or their family/friends ( . %) had contracted covid- , one quarter ( . %) of respondents were very or extremely worried about contracting covid- , and over half ( . %) were very or extremely worried about their family and friends contracting covid- . almost four in five participants reported that since the outbreak their mental health had worsened, with over half ( %) saying it had worsened a little, and almost a quarter of respondents ( %) saying it had worsened a lot. a small minority reported better mental health ( . %). results showed that many people are experiencing high levels of uncertainty about the future ( %), and half of respondents reporting moderate to extreme loneliness and worry about their financial situation. given loneliness, social isolation, and financial stress are significant risk factors for poor mental and physical health, and risk factors for suicidal ideation [e.g., , , ] , these findings are concerning. to rapidly respond to the evolving covid- situation, we administered online validated self-report questionnaires rather than diagnostic interviews. it is important to note that these questionnaires assessed symptoms of distress during the past week and should not be taken as indicative of a 'diagnosis' of a depressive or anxiety disorder. we found higher than expected levels of acute distress based on research in china during the covid- pandemic [ ] , and compared to normative data [ , ] . between . - . % of the current sample were experiencing severe or extremely severe levels of depression, anxiety and stress, and a further - % moderate symptoms. only % of the current sample had normal depression, % had normal anxiety, and % had normal stress levels, whereas in the chinese sample reported by wang et al. [ ] - % had normal anxiety, stress and depression on the dass- . these differences may be due to the high proportion of people with pre-existing mental health diagnoses ( %) in our sample, which have been shown to be a vulnerable group [ , ] , or because of the significant proportion with a self-reported chronic illness ( %), who may be more susceptible to more severe covid- disease, and therefore more all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . distressed. having a personal history of chronic illness was a consistent predictor of higher depression, anxiety and stress, whereas better self-rated health was associated with better mental health. compared to the australian population, this sample appeared to have poorer health, with % reported being in fair or poor health (compared to % in the australian population), and % reporting being in very good or excellent health (compared to % of australians) [ ] . our data gave some insights into other demographic variables which predict higher psychological distress. specific occupational factors predicted higher distress levels: student status (depression and anxiety), being an at home parent (depression and stress), a carer or retired (predicted higher depression), whereas education was associated with lower psychological distress. in contrast to past research, identifying as female predicted lower depression, however identifying as non-binary or a different gender identity was associated with higher self-reported anxiety and stress. identifying as aboriginal or torres strait islander also predicted worse anxiety and stress levels. these groups may be particularly vulnerable during the current pandemic, and longitudinal research is needed to explore the longer term predictors of poorer mental health over time. our results confirm fears about the potential impact of the covid- pandemic on people with lived experience of mental illness [ ] . participants with a self-reported history of mental health problems were more afraid of covid- and more worried about their loved ones contracting covid- , had higher distress, depression, anxiety, health anxiety and contamination fears, and higher rates of elevated health anxiety ( % versus %) than those without pre-existing mental health diagnoses. relative to those without mental health issues, a greater proportion of people with self-reported mental health problems had elevated health anxiety ( % versus %), and said their mental health had been 'a lot worse' since the outbreak ( % versus %). having a history of mental health issues was a consistent predictor of higher depression, anxiety and stress. because we did not collect any information about the history and nature of these mental health diagnoses, we cannot determine whether these individuals had higher distress prior to the pandemic, or whether distress increased as a result of the pandemic, due to inability to access usual supports, social isolation or loneliness [ ] . however, our findings highlight the need for proactive mental health all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . interventions for those who are experiencing elevated symptoms of depression, anxiety and stress during the current covid- pandemic, regardless of whether the distress is an exacerbation or recurrence of pre- existing mental health concerns, or new onset. digital interventions, which have been shown to be highly effective and cost-effective for depression and anxiety treatment [ ] will be crucial to respond to these ongoing mental health concerns, as they have capacity to deliver high quality interventions for distress at scale, and to those in social isolation who are unable to attend face-to-face services [ , ] . this study provides new knowledge about the rates of health anxiety during the covid- pandemic. over one in four ( %) of people with a prior history of mental health issues, and % of those without pre-existing mental health issues reported elevated health anxiety in the past week, which is higher than rates of health anxiety in the general australian population ( . % [ ]), and closer to the rates of health anxiety observed in general practice ( %) and outpatient medical clinic settings ( - %) [ ] . while these symptoms are not necessarily indicative of illness anxiety disorder, high health anxiety is likely to have significant ramifications for health service utilisation. responses to health anxiety vary substantially, with responses ranging from a complete avoidance of doctors, hospitals, and medical settings due to fear, to the other end of the spectrum of excessive, repeated, and unnecessary health service use, diagnostic testing, emergency visits and paramedic calls [ ] . proactive treatment of health anxiety with digital interventions may also be needed should these symptoms persist [ , ] . in prior research, risk perceptions, including the perceived risk of contracting the virus, perceived control over the virus, and the perceived seriousness of the symptoms have been shown to be associated with psychological distress, and behavioural responses to disease outbreaks. consistent with the findings of sars pandemics, and our previous study, we found moderate perceptions of risk of contracting the virus. participants rated on average that there was a % likelihood of contracting the virus personally, and higher perceived risk was associate with higher depression and stress levels. in the current cohort approximately one third of participants expected covid- to lead to severe symptoms ( . %), and in some cases death ( %), which is higher than in our previous study, where we found only % expected severe symptoms. the expected severity of the covid- illness differs markedly to the reality for most people, as studies show that % of people will experience no or mild symptoms [ ] . these findings reinforce the need for all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . education campaigns to address these misperceptions, especially as research has shown that these beliefs are associated with engagement with distress. these risk perceptions explained a relatively small amount of variance in the regression analyses, with perceived control over covid- a consistent predictor of better mental health and higher perceived severity of illness associated with higher depression and anxiety. however, it is important to note that other predictors, including loneliness, financial stress, uncertainty, demographic factors, and prior history of mental and chronic illness were stronger predictors of distress. similar to wang et al. [ ] , some of the most common precautionary behaviours were avoiding touching objects that had been touched by others, washing hands, and using hand sanitiser. participants also commonly reported staying at home and avoiding social events and socialising with others outside of the household. in contrast to media portrayals of panic buying, excessive purchasing behaviour was not common. in previous research, higher engagement in hygiene behaviours, such as handwashing have been associated with lower distress and anxiety, suggesting behavioural control may be protective for mental health. however, in the current cohort we found some inconsistent results, with engagement in more hygiene behaviours associated with higher anxiety and stress levels (they were not associated with depression). these findings differ to the findings of wang et al. [ ] during the early stages of the epidemic in china, where the use of precautionary measures, such as avoiding sharing utensils, hand hygiene and wearing masks were associated with lower stress, anxiety and depression. however, the current findings are consistent with some research from the sars epidemic, in which moderate levels of anxiety were associated with higher uptake of precautionary behaviours [ ] . it is possible that the association we found was due to people who were higher in anxiety or stress using these behaviours in an attempt to control anxiety. finally, concerns have been raised about the potential impact of social isolation and quarantine on physical inactivity, as well as increased alcohol use and abuse. on the audit-c brief screener for alcohol use, approximately . % met criteria for hazardous drinking levels, which is higher than the % found in primary care samples in australia [ ] and higher than usa-based population samples ( %- %) [ ] . however it is important to note that participants with a prior experience of mental health problems had lower rates of hazardous drinking, and lower rates of inactivity. in the current sample, . % met the all rights reserved. no reuse allowed without permission. was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint (which this version posted may , . . world health organisation. coronavirus disease (covid- ) situation report expected impact of covid- on the mental health of health professionals. a systematic review and meta-analysis of studies from the current and previous pandemics stress and psychological impact on sars patients during the outbreak. can j psychiatry psychological effects of the sars outbreak in hong kong on high-risk health care workers long-term psychiatric morbidities among sars survivors. general hospital psychiatry coping responses of emergency physicians and nurses to the severe acute respiratory syndrome outbreak multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science. the lancet psychiatry immediate psychological responses and associated factors during the initial stage of the coronavirus disease (covid- ) epidemic among the general population in china. int impact of the covid- pandemic on mental health and quality of life among local residents in liaoning province, china: a cross-sectional study a nationwide survey of psychological distress among chinese people in the covid- epidemic: implications and policy recommendations. general psychiatry factors associated with mental health outcomes among health care workers exposed to coronavirus disease a longitudinal study on the mental health of general population during the covid- epidemic in china generalized anxiety disorder, depressive symptoms and sleep quality during covid- epidemic in china: a web-based cross-sectional survey. medrxiv public 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and practical health care: an updated meta-analysis the covid- pandemic: the 'black swan' for mental health care and a turning point for e-health. internet interventions health anxiety in australia: prevalence, comorbidity, disability and service use prevalence of health anxiety problems in medical clinics diagnostic and statistical manual of mental disorders : dsm- internet-based cognitive behavioral therapy versus psychoeducation control for illness anxiety disorder and somatic symptom disorder: a randomized controlled trial exposure-based cognitive-behavioural therapy via the internet and as bibliotherapy for somatic symptom disorder and illness anxiety disorder: randomised controlled trial characteristics of and important lessons from the coronavirus disease (covid- ) outbreak in china the impact of community psychological responses on outbreak control for severe acute respiratory syndrome in hong kong do rates of depression vary by level of alcohol misuse in australian general practice? %j australian journal of primary health inconsistencies between alcohol screening results based on audit-c scores and reported drinking on the audit-c questions: prevalence in two us national samples chronic widespread musculoskeletal pain, fatigue, depression and disordered sleep in chronic post-sars syndrome; a case-controlled study key: cord- -hl ln r authors: tulchinsky, theodore h.; varavikova, elena a. title: planning and managing health systems date: - - journal: the new public health doi: . /b - - - - . - sha: doc_id: cord_uid: hl ln r health systems are complex organizations. they are often the largest single employer in a country, with expenditures of public and private money of – percent of gross domestic product. overall and individual facility management requires mission statements, objectives, targets, budgets, activities planning, human interaction, services delivery, and quality assurance. health organization involves a vast complex of stakeholders and participants, suppliers and purchasers, regulators and direct providers, and individual patients, and their decision-making. these include pyramidal and network organizations and ethical decision-making based on public interest, resource allocations, priority selection, and assurance of certain codes of law and ethical conduct. this chapter discusses how complex organizations work, with potential for application in health, and the motivations of workers and of the population being served. organization theory helps in devising methods to integrate relevant factors to become more effective in defining and achieving goals and missions. health systems are complex organizations and their management is an important concept in the new public health. health is a major sector of any economy and often employs more people in the industrialized countries than any other industry. health has complex networks of services and provider agencies, including funding through public or private insurance or through national health service systems. whether insurance is provided by the state or through private and public sources combined, skilled management is required at the macro-or national and the micro-or local level, including the many institutions that make up the system. management training of public health professionals and clinical services personnel is a requisite and not a luxury. planning and management are changing in the era of the new public health with advances in prevention and treatment of disease, population health needs, innovative technologies such as genetic engineering, new immunizations that prevent cancers and infectious diseases, prevention of non-communicable diseases, environmental and nutritional health, and health promotion to reduce risk factors and improve healthful living for the individual and the community. modern and successful public health also must address social, economic, and community determinants of health and the promotion of public policies and individual behaviors for health and well-being. the social capital and norms that promote cooperation among people are the basis of a "civil society" (i.e., the totality of voluntary, civic, and social organizations and institutions of a functioning society alongside the structures of governmental and commercial institutions). health systems are ideally knowledge-and evidence-based in using technologies available in medicine and the environment to promote the health and well-being of a population, including security against the effects of threatened terrorism, growing social isolation, and inequities in health. management in health can learn much from concepts of business management that have evolved to address the economic and human resource aspects of a health system at the macrolevel or an individual unit of service at the microlevel. the new public health is not contained within one organization, but rather reflects the collective efforts of national, state, regional, and local governments, many organizations in the public and non-governmental sectors, and finally efforts of individual or group advocates and providers and the public itself. the political level is crucial for adequate funding, legislation, and promotion of health-oriented policy positions and in public health management. the responsibility for health management is shared across all parts of society, including individuals, communities, business, and all levels of government. the new public health identifies and addresses community health risks and needs. planning is critical to the process of keeping a health system sustainable and adaptable and in creating adequate responses to new health threats. monitoring, measurement, and documentation of health needs are vital to design and adapt an effective program and to measure impact. data on the targeted issues must be accessible while protecting individual privacy. health is a hugely expensive and expansive complex of services, facilities, and programs provided by a wide range of professional and support service personnel making up one of the largest employers of any sector in a developed country. services are increasingly delivered by organized groups of providers. but all health systems operate in an environment of economic constraints, imposing a need to seek efficiency in the use of resources. how organizations function is of great importance not only for their economic survival, but also, and equally important, for the well-being of the clients and providers of care. an organization is two or more people working together to achieve a common goal. management is the process of defining the goals and making effective use of an organization to attain those goals. even very small units of a human organization require management. management of human resources is vital to the success of an organization, whether in a production or service industry. health systems may chapter vary from a single structure to a network of many organizations. no matter how organizations are financed or operated, they require management. management in health care has much to learn from approaches to management in other industries. elements of theories and practices of profit-oriented sector management can be applied to health services even if they are operated as non-profit enterprises. physicians, nurses, and other health professionals will very likely be involved in the management of some part of the health care system, whether a hospital department, a managed care system, a clinic, or even a small health care team. at every level, management always means working with people, using resources, providing services, and working towards common objectives. health providers require preparation in the theory and practice of management. a management orientation can help providers to understand the wider implications of clinical decisions and their role in helping the health care system to achieve goals and targets. students and practitioners of public health need preparation in order to recognize that a health care system is more complex than the direct provision of individual services. similarly, policy and management personnel need to be familiar with both individual and population health needs and related care issues. health has evolved from an individual one-on-one service to complex systems organized within financing arrangements, mostly under government auspices. as a governmental priority, health may be influenced by political ideology, sometimes reflecting societal attitudes of the party in power and sometimes apparently at odds with its general social policy. following bismarck's introduction in germany in of national health insurance for workers and their families, funded by both workers and their employers, most countries in the industrialized world introduced variants of this national health plan. usually, this has been at the initiative of socialist or liberal political leadership, but conservative political parties have preserved national health programs once implemented. despite the new conservatism since the s with its pre-eminent ideology of market forces, the growing roles for national, state, and local authorities in health have led to a predominantly government role in financing and overall responsibility for health care, even where there is no universal national health system, as in the usa. the uk's national health service (nhs), initiated by a labour government in , has survived through many changes of government, including the conservative margaret thatcher period in which many national industries and services were privatized. health policy is a function of national (government) responsibility overall for health, but implementation is formulated and met at state, local, or institutional levels. the division of responsibilities is not always clear cut but needs to be addressed and revised both professionally and politically within constitutional, legal, and financial constraints. selection of the direction to be taken in organizing health services is usually based on a mix of factors, including the political view of the government, public opinion, and rational assessment of needs as indicated through epidemiological data, cost-benefit analysis, the experience of "good public health practice" from leading countries, and recommendations by expert groups. lobbying on the part of professional or lay groups for particular interests they wish to promote is part of the process of policy formulation and has an important role in the planning and management of health care systems. there are always competing interests for limited resources of funding, by personnel within the health field itself and in competition with other demands outside the health sector. the political level is vitally involved in health management in establishing and maintaining national health systems, and in determining the place of health care as a percentage of total governmental budgetary expenditures, in allocating funds among the competing priorities. these competing priorities for government expenditures include defense, roads, education, and many others, as well as those within the health sector itself. traditionally, there are competing priorities between the hospital and medical sector and the public health and community programs sector. a political commitment to health must be accompanied by allocation of resources adequate to the scope of the task. thus, health policy is largely determined by societal priorities and is not a prerogative of government, health care providers, or any institution alone. as a result of long struggles by trade unions, advocacy groups, and political action, well-developed market economies have come to accept health as a national obligation and essential to an economically successful and well-ordered society. this realization has led to the implementation of universal access systems in most of the industrialized countries. once initiated, national health systems require high levels of resources, because the health system is labor intensive with relatively high salaries for health care professionals. in these countries, health expenditures consume between and nearly percent of gross domestic product (gdp). some industrialized countries, notably those in the former soviet bloc, lacking mechanisms for advocacy, including consumer and professional opinion, tended to view health with a political objective of social benefits, and also as a "non-productive" consumer of resources rather than a producer of new wealth. as a result, budget allocations and total expenditures for health as a percentage of gdp were well below those of other industrialized countries (figure . ). salaries for health personnel in the semashko system were low compared to industrial workers in the "productive" sectors. furthermore, industrial policy did not promote modern health-related industries, compared to the military or heavy industrial sectors. the former socialist countries of eastern europe which have joined the european union (eu) have gradually increased allocation to health from . percent of gdp in to . percent in , while the pre- members of the eu increased their expenditures from . percent of gdp to . percent. the average spend in the commonwealth of independent states (russia, ukraine, and others) increased from . percent in to . percent in , and in the central asian republics (kazakhstan, uzbekistan, and others) from . percent in to . percent in (who health for all database, january ). however, russian health expenditure in was still only . percent of gdp and there is a lingering idea of health being a non-productive investment. the developing countries generally spend under percent of gnp on health, because health is addressed as a relatively low political priority, and they depend very much on international donors for even the most basic of public health programs such as immunization. financing of health care and resource allocation requires a balance among primary, secondary, and tertiary care. economic assessment, monitoring, and evaluation are part of determining the health needs of the population. regulatory agencies are responsible for defining goals, priorities, and objectives for resulting services. targets and methods of achieving them provide the basis for implementation and evaluation strategies. planning requires written plans that include a statement of vision, mission objectives, target strategies, methods, and coordination during the implementation. designation and evaluation of responsibilities, resources to be committed, and participants and partners in the procedure are part of the continuous process of management. the dangers of taking a "wrong" direction may be severe, not only in terms of financial costs, but also in terms of high levels of preventable morbidity and mortality. health policy is often as imprecise a science as medicine itself. the difference is that inappropriate policy can affect the lives and well-being of very large numbers of people, as opposed to an individual being harmed by the mistake of one doctor. there may be no "correct" answer, and there are numerous controversies along the path. health policy remains more an "art" than the more quantitative and seemingly precise field of health economics. societal, economic, and cultural factors as well as personal habits have long been accepted as having an important impact on vulnerability to coronary heart disease. but other factors such as the degree of control over one's life, as suggested in studies of british civil servants, religiosity, and the effects of migration on families left behind are part of the social gradients and inequalities seen in many disease entities, with consequent excess morbidity and mortality in some contexts, such as in russia and ukraine. health policy, planning, and management are interrelated and interdependent. any set goal should be accompanied by planning how to attain it. a policy should state the values on which it is based, as well as specify sources of funding, planning, and management arrangements for its implementation. examination of the costs and benefits of alternative forms of health care helps in making decisions as to the structure and the content of health care services, both internal structures (within one organization) and external linkages (intersectoral cooperation with other organizations). the methods chosen to attain the goals become the applied health policy. the world health organization's (who's) health for all strategy was directed at the political level and intended to increase governmental awareness of health as a key component of overall development. to some degree it succeeded despite its expansive aspirations, and even after nearly years, its objectives remain worthwhile even in well-developed health systems. within health, primary care was stressed as the most effective investment to improve the health status of the population. in , the world bank's world development report adopted the health for all strategy and promoted the view that health is an important investment sector for general economic and social development. however, economic policies promoting privatization and deregulation in the health sector threaten to undermine this larger goal in countries with national health systems. in the usa, major steps are being taken to increase coverage of health insurance for all as the number of uninsured americans declined from million people uninsured in to . million in , edging down from . to . percent of the total population. further decline in the uninsured population is expected as the patient protection and affordable care act (ppaca, or "obamacare") comes into effect in the coming years, bringing many millions of americans into health insurance and meeting federal standards of fair practices such as eliminating exclusion for preexisting conditions by private insurers. the ppaca comes into effect on january and will guarantee coverage for pre-existing conditions, and ensure that premiums cannot vary based on gender or medical history. it will subsidize the cost of coverage, and new state-based health insurance exchanges will help consumers to find suitable policies. it will introduce many preventive care measures into public and private insurance plans, and will promote efficiencies in the health systems including reduction in fraudulent claims and wasteful funding systems. all of this will require skilled management in the components of the health system (see chapters and ). in the new public health, health promotion, preventive care, and clinical care are all part of public health because the well-being of the individual and the community requires a coordinated effort from all elements of the health spectrum. establishing and achieving national health goals require planning, management, and coordination at all levels. the achievement of health advances depends on organizations and structured efforts to reach health goals such as those defined above, and more recently by the united nations (un) in the millennium development goals (mdgs) (see chapter ), and requires some understanding of organizations and how they work. the study of organizations developed within sociology, but has gradually become a multidisciplinary activity involving many other professional fields, such as economics, anthropology, individual and group psychology, political science, human resources management, and engineering. organizations, whether in the public or private sector, exist within an external environment, and utilize their own structure, participants, and technology to achieve goals. for an organization to survive and thrive, it must adapt to the physical, social, cultural, and economic environment. organizations participating in health care establish the connection between service providers and consumers, with the goal of better health for the individual and the community. the factors for this include legislation, regulation, professionalism, instrumentation, medications, vaccines, education, and other modalities of intervention for prevention and treatment. the social structure of an organization may be formal (structured stability), natural (groupings reflecting common interests), or open (loosely coupled, interacting, and self-adjusting systems to achieve goals). formal systems are deliberately structured for the purposes of the organization. natural systems are less formal structures where participants work together collaboratively to achieve common goals defined by the organization. open systems relate elements of the organization to coalitions of partners in the external environment to achieve mutually desirable goals. in the health system, structures should focus on prevention and treatment of disease and improvement in health and well-being of society. the social structure of an organization includes values, norms, and roles governing the behavior of its participants. government, business, or service organizations, including health systems, require organizational structures, with a defined mission and set of values, in order to function. an organizational structure needs to be tailored to the size and complexity of the entity and the goals it wishes to achieve. the structure of an organization is the way in which it divides its labor into distinct tasks and coordinates them. the major organizational models, which are not mutually exclusive and may indeed be complementary, are the pyramidal (bureaucratic) and network structures. the bureaucratic model is based on a hierarchical chain of command with clearly defined roles. in contrast, the matrix or network organization brings together professional or technical people to work on specific programs, projects, or tasks. both are vital to most organizations to meet ongoing responsibilities and to address special challenges. some classic organization theory concepts help to set the base for modern management ideas as applied to the health sector. scientific management was pioneered by frederick winslow taylor . his work was pragmatic and based on empirical engineering, developed in observational studies carried out for the purpose of increasing worker, and therefore system, efficiency. taylor's industrial engineering studies of scientific management were based on the concept that the best way to improve worker productivity was by designing improved techniques or methods used by workers. this theory viewed workers as instruments to be manipulated by management, and assumed that efficient, rationally planned methods would produce better industrial results and industrial peace as the tasks of managers and workers would be better defined. time and motion studies analyzed work tasks to seek more efficient methods of work in factories. motivation of workers was seen to be related to payment by piecework and economic self-interest to maximize productivity. taylor sought to improve the productivity of each worker and to make management more efficient in order to increase earnings of employers and workers. he found that the worker was more efficient and productive if the worker was goal oriented rather than task oriented. this approach dominated organization theory during the early decades of the twentieth century. resistance to taylor's ideas came from both management and labor; the former because it seemed to interfere with managerial prerogatives and the latter because it expected the worker to function at top efficiency at all times. however, taylor's work had a lasting influence on the theory of work and organizations. the traditional pyramidal bureaucratic organization is classically seen in the military and civil services, but also in large-scale industry, where discipline, obedience, and loyalty to the organization are demanded, and individuality is minimized. this form of organization was analyzed by sociologist max weber between and . leadership is assigned by higher authority, and is presumed to have greater knowledge than members lower down in the organization. this form of organization is effective when the external and internal environments, the technology, and functions are relatively well defined, routine, and stable. the pyramidal system (figure . ) has an apex of policy and executive functions, a middle level of management personnel and support staff, and a base of the people who produce the output of the organization. the flow of information is generally one way, from the bottom to the top level, where decisions are made for the detailed performance of duties at all levels. lateralizing the information systems so that essential data can be shared to help staff at the middle and field or factory-floor levels of management is generally discouraged because this may promote decentralized rather than centralized management. even these types of organization have increasingly come to emphasize small-group loyalty, leadership initiative, and self-reliance. the bureaucratic organization has the following characteristics: l there is a fixed division of labor with a clear jurisdiction and based on assignments, which are subject to change by the leader. l there is a hierarchy of offices, with each lower functionary controlled and supervised by a higher one. employment is viewed as a tenured career for officials, after an initial trial period. the bureaucratic system, based on formal rationality, structure, and discipline, is widely used in production, service, and governmental agencies, including military and civilian departments and agencies. health systems, like other organizations, are dynamic and require continuous management, adjustment, and systems control. continuous monitoring and feedback, evaluation, and revision help to meet individual and community needs. the input-process-output model (figure . ) depends on feedback systems to make the administrative or educational changes needed to keep moving towards the selected objectives and targets. organizations use resources or inputs that are processed to achieve desired results or outputs. the resource inputs are money, personnel, information, and supplies. process is the accumulation of all activities taken to achieve the results intended. output, or outcome, is the product, its marketing, its reputation and quality, and profit. in a service sector such as health, output or impact can be measured in terms of reduced morbidity and/or mortality, improved health, or number of successfully treated and satisfied patients at affordable costs. the management system provides the resources and organizes the process by which it hopes to achieve the established goals. program implementation requires systematic feedback for the process to work effectively. when targets are set and strategy is defined, resources, whether new or existing, are placed at the service of the new program. management is then responsible for using the resources to achieve the intended targets. the results are the outcome or output measures, which are evaluated and fed back to the input and process levels. health systems consist of many subsystems, each with an organization, leaders, goals, targets, and internal information systems. subsystems need to communicate within themselves, with peer organizations, and with the macro (health) system. leadership style is central to this process. the surgeon as the leader of the team in the operating room depends on the support and judgment of other crucial people on the team, such as anesthesiologists, operating room nurses, pathologists, radiologists, and laboratory services, all of whom lead their own teams. hospital and public health directors cannot function without a high degree of decentralized responsibility and a creative team approach to quality development of the facility. health systems management includes analysis of service policy, budget, decision-making in policy, as well as operation, regulation, supervision, provision, maintenance, ethical standards, and legislation. policy formulation involves a set of decisions made in pursuit of a course of action for achieving selected health targets, such as those in the mdgs or continuing to update healthy people health targets in the usa (see chapter ). cybernetics, a term coined by norbert wiener, refers to systems or organizations which are dependent on each other to function, and whose interdependence requires flexibility of response. cybernetics gained wide credence in engineering in the early s, and feedback systems became part of standard practice of all modern management systems. its later transformations appeared in operating service systems, as information for management. application of this concept is entering the health sector. rapid advances in computer technology, by which personal computers have access to internet systems and large amounts of data, have already enhanced this process. in mechanistic systems, the behavior of each unit or part is constrained and limited; in organic systems, there is more interaction between parts of the system. the example used in figure . is the use of a thermostat to control the temperature and function of a heater according to conditions in the room. this is also described as a feedback system. cybernetics opens up new vistas on the use of health information for managing the operation of health systems. a database for each health district would allow assessment of current epidemiological patterns, with appropriate comparisons to neighboring districts or regional, state, and national patterns. data would need to be processed at state or national levels in comparable forms for a broad range of health status indicators. furthermore, the data should be prepared for online availability to local districts in the form of current health profiles. thus, data can be aggregated and disaggregated to meet the management needs of the service, and may be used to generate real targets and measure progress towards meeting them. a geographic information system may demonstrate high rates of a disease in a region due to local population risk factors, and thus become the basis for an intervention program. in the health field, the development of reporting systems based on specific diseases or categories has been handicapped by a lack of integrative systems and a geographic reporting approach. the technology of computers and the internet should be used to process data systems in real time and in a more user-friendly manner. this would enable local health authorities and providers to respond to actual health problems of the communities. health is a knowledge-based service industry, so that knowledge management and information technology are extremely important parts of the new public health, not only in patient care systems in hospitals, but also in public health delivery systems in the community, school, place of work, and home. mobilization of evidence and experience of best practices for policies and management decisionmaking is a fundamental responsibility of health leaders. the gap between information and action is wide and presents an ethical as well as a political challenge. regions with the most severe health problems lack trained personnel in assessment and exploitation of current state-of-the-art practices and technology in many practical public health fields, including immunization policy and in management of risk factors for stroke. knowledge and evidence are continuously evolving, but the capacity to access and interpret information is commonly poorly implemented in many countries so that very large numbers of people die of preventable diseases even when there are, overall, sufficient resources to address the challenges. international guidelines are vital to help countries to adopt current standards and make use of the available knowledge for public policy. political support and openness to international norms are crucial to this process of technology diffusion and building the physical and human resource infrastructure needed to achieve better population health with current best practices. development of health standards in low-income countries is progressing but is seriously handicapped by low levels of funding, lack of emphasis on training sufficient and appropriate human resource personnel and administrative support to promote measures which can save millions of lives. in high-income countries, the slow adoption of best international health standards can have harsh effects on population health, such as in the long delay in adopting national health insurance in the usa. in the european context, the eu has failed to adopt a harmonized recommended immunization program, which is badly needed for the new and potential members, as well as the older member countries. in countries of the former socialist bloc, mortality rates from stroke and coronary heart disease are slowly declining but remain two to four times higher than in countries of western europe (see chapter ). systems management requires access to and the use of knowledge to bridge these gaps. adoption and adaptation of knowledge to address local problems are essential in a globalized world, if only to prevent the international spread of threatened pandemics or adoption of unhealthy lifestyles (diet, smoking, and lack of exercise) to middle-income countries, which are developing a growing middle class alongside massive poverty. the application of knowledge and experience that has been successful in leading countries can foster innovation and create experience that may generate a local renewal process. management is crucial to address the complex "strategy areas for improving performance of health organizations: standards and guidelines, organizational design, education and training, improved process, technology and tool development, incentives, organizational culture, and leadership and management" (bradley et al., ) . managing a knowledge-based service industry or facility relies on leadership, collaboration to realize the potential of technology, professional skills, and social capital to the address the health problems faced by all countries. the management of resources to achieve productivity and measurable success has been characterized and accompanied by the development of systems of organizing people to create solutions to problems or to innovate towards defined objectives. operations research is a concept developed by british scientists and military personnel in search of solutions for specific problems of warfare during world wars i and ii. the approach was based on the development of multidisciplinary teams of scientists and personnel. the development of the anti-submarine detection investigation committee for underwater detection of submarines during world war i characterized and pioneered this form of research. the famous bletchley park enigma code-breaking success in britain and the manhattan project, in which the usa assembled a powerful research and development team which produced the atomic bomb, are prime world war ii examples. team-and goal-oriented work was very effective in problem solving under the enormous pressure of wartime needs. it also influenced postwar approaches to developmental needs in terms of applied science in such areas as the aerospace and computer industries. the computer hardware and software industries are characterized by innovation conceived and developed through informal working groups with a high level of individual competence, peer group dynamism, and commitment to problem solving. thus, the "nerds" of macintosh and microsoft beat the "suits" of ibm in innovation and introduction of the personal computer. similar startup groups, such as google and facebook, successfully took the internet to startling new levels of global applications, showing the capacity of innovation from california's silicon valley and its counterparts in other places in the usa and worldwide. in the health field, innovation in organization developed prepaid group practice which became the health maintenance organization (hmo), and later the managed care organization (mco), now a major, if controversial, factor in health care provision in the usa. other examples may be found in multidisciplinary research teams working on vaccines or pharmaceutical research, and in the increasingly multidisciplinary function of hospital departments and especially highly interdependent intensive care or home care teams. the business concept of management by objectives (mbo), pioneered in the s, has become a common theme in health management. mbo is a process whereby managers of an enterprise jointly identify its goals, define each individual's areas of responsibility in terms of the results expected, and use these measures as guides for operating the unit and assessing the contributions of its members. the common goals and then the individual unit goals must be established, as well as the organizational structure developed to help achieve these goals. the goals may be established in terms of outcome variables, such as defined targets for reduction of infant or maternal mortality rates. goals may also be set in terms of intervening or process variables, such as achieving percent immunization coverage, prenatal care attendance, or screening for breast cancer and mammography. achievements are measured in terms of relevancy, efficiency, impact, and effectiveness. the mbo approach has been subject to criticism in the field of business management because of its stress on mechanical application of quantitative outcome measures and because it ignores the issue of quality. this approach had great influence on the adoption of the objective of "health for all" by the who, and on the us department of health and human services' health targets for the year , later as healthy people , and now, based on these experiences and new evidence, renewed as healthy people . targeting diseases for eradication may contribute to institution building by developing experience and technical competence to broaden the organizational capacity. however, categorical programs or target-oriented programs can detract from the development of more comprehensive systems approaches. addressing the mdgs of reducing child and maternal mortality is at odds to some extent with targeting poliomyelitis for eradication and reliance on national immunization days, which distract planning and resource allocation for the buildup of the essential public health infrastructure for the basic immunization system so fundamental to child health. immunization and human immunodeficiency virus (hiv) control draw the major part of donor resources in developing countries, while education for strengthening human resources and infrastructure draw less donor attention. a balance between comprehensive and categorical approaches requires very skilled management. the mdgs agreed to by the un in as targets for the year provide a set of measurable objectives and a formula for international aid and for national development planning to help the poorest nations, with the wealthy nations providing aid, education, debt relief, and economic development through fairer trade practices. they are now being reviewed for extension to based on experience to date, with successes and failures, and recognizing the vital importance of non-communicable diseases as central to the health burden of low-and middleincome countries. management is the activity of coordinating and integrating organizational resources, including people, money, materials, time, and space. the purpose is to achieve defined/ stated objectives as effectively and efficiently as possible. whether in terms of producing goods and profits or in delivering services effectively, management deals with human motivation and behavior because workers are the key to achieving goals. knowledge and motivation of the individual client and the community are also essential for achieving good health. thus, management must take into account the knowledge, attitudes, beliefs, and practices of the consumer as much as or more than those of the people working within the system, as well as the general cultural and knowledge level in the society, as reflected in the media, political opinions, and organizations addressing the issues. management, like medicine, is both a science and an art. the application of scientific knowledge and technology in medicine involves both theory and practice. similarly, management practice involves elements of organizational theory, which, in turn, draws on the behavioral and social sciences and quantitative methodologies. sociology, psychology, anthropology, political science, history, and ethics contribute to the understanding of psychosocial systems, motivation, status, group dynamics, influence, power, authority, and leadership. quantitative methods including statistics, epidemiology, survey methods, and economic theory are also basic to development of systems concepts. comparative institutional analysis helps principles of organization and management to develop, while philosophy, ethics, and law are part of understanding individual and group value systems. organizational theory, a relatively new discipline in health, as an academic study of organizations, addresses health-related issues using the methods of economics, sociology, political science, anthropology, and psychology. the application of organizational theory in health care has evolved and become an integral part of training for, and the practice of, health administration. related practical disciplines include human resources, and industrial and organizational psychology. translation of organizational theory into management practice requires knowledge, planning, organization, mobilization of professional and other staff support for evidence-based best practices, assembly of resources, motivation, monitoring and control. health organizations have become more complex and costly over time, especially in their mix of specializations in science, technology, and professional services. organization and management are particularly crucial for successful application of the principles of the new public health, as it involves integration of traditionally separate health services. delegation of responsibilities in health systems, such as in intensive care units, is fundamental to success in patient care, with nurses taking increasing responsibility for the management of the severely ill patient suffering from multiple system failure. delegation or devolution of health care responsibilities to non-medical practitioners has been an ongoing development affecting nurse practitioners, physician assistants, paramedics, community health workers and others, as discussed in chapter . it is a vital process to provide needs not met by physicians because of shortages and inappropriate location or specialty preferences that leave primary care or other medical specialties unable to meet community and patient needs. elton mayo of the harvard school of business carried out a series of observational studies at the hawthorne, illinois, plant of the western electric company between and . mayo and his industrial engineer, along with psychologist colleagues, made a major contribution to the development of management theory. mayo began with industrial engineering studies of the effect of increased lighting on production at an assembly line. this was followed by other improvements in working conditions, including reduced length of the working day, longer rest periods, better illumination, color schemes, background music, and other factors in the physical environment. these studies showed that production increased with each of these changes and improvements. however, the researchers discovered, to their surprise, that production continued to increase when the improvements were withdrawn. furthermore, in a control group where conditions remained the same, productivity also grew during the study period. these results led mayo to conclude that the performance of workers improved because of a sense that management was interested in them, and that worker participation contributes to improved production. traditionally, industrial management viewed employees as mechanistic components of a production system. previous theory was that productivity was a function of working conditions and monetary incentives. what came to be known as the hawthorne effect showed the importance of social and psychological factors on productivity. formal and informal social organizations among management and employees were recognized as key elements in productivity, now called industrial humanism. research methods adapted from the behavioral sciences contributed to scientific studies in industrial management. traditional theories of the bureaucratic model of organization and management were modified by the behavioral sciences. this led to the emergence of the systems approach, or scientific analysis to analyze complex structures or organizations, taking into account the mutually interdependent elements of activities, interactions, and interpersonal relationships between management and workers. some revisits to the hawthorne studies suggest that the data do not support the conclusions, and offer a different interpretation. one is that informal groups such as workers on a production line themselves set standards for work which assert an informal social control outside the authority system of the organization. the informal cohesive group can thus control the norms of the amount of work acceptable to the group, i.e., not "too much" and not "too little". others point out that the effects were temporary and that there were extraneous factors, but the added value of the hawthorne effect remains part of the history of and had a culturechanging effect on management theory. the hawthorne effect in management is in some ways comparable to the placebo effect in clinical research and health care practice. it is also applied to clinical practice, whereby medical care provided by doctors is measured for specific "tracer conditions" to assess completeness of care according to current clinical guidelines. review of clinical records has been shown to be a factor in improving performance by doctors in practice, such as in treatment of acute myocardial infarction, management of hypertension, or completeness of carrying out preventive procedures such as screening for cancer of the cervix, breast, or colon (see chapters and ). awareness of being studied is a factor in improved performance or response to an intervention. studies of clinical practice-based research or public health interventions need to consider whether different types of studies and outcomes are more or less susceptible to the hawthorne effect (fernald et al., ). abraham maslow's hierarchy of human needs made an important contribution to management theory. maslow was an american psychologist, considered "the father of humanism" in psychology. maslow defined a prioritization of human needs (figure . ), starting with those of basic physical survival; at higher levels, human needs include social affiliation, self-esteem, and self-fulfillment. others in the hierarchy include socialization and self-realization; later revisions include cognitive needs. the survival needs of an employee include a base salary and benefits, including health insurance and pension; the safety and security needs include protection from injury, toxic exposure or excess stress; social needs at work include an identity, pride, friendships, union solidarity, company social activities and benefits; esteem and recognition include job titles, awards, and financial rewards for achievement by individuals, groups, or all employees; and self-actualization includes promotion to more challenging jobs with benefits, both financial and in terms of recognition. this concept is important in terms of management because it identifies human needs beyond those of physical and economic well-being. it relates them to the social context of the work environment with needs of recognition, satisfaction, self-esteem, and self-fulfillment. maslow's conclusions opened many positive areas of management research, not only in the motivation of workers in production and service industries, but also in the motivation of consumers. maslow's hierarchy of human needs contributed to the idea that workers' sense of well-being is important to management. his theories played an important role in application of sociological theory to client behavior, just as the topic of personal lifestyle in health became a central part of public health and clinical management of many conditions, such as in risk factor reduction for cardiovascular diseases. this concept fits well with the epidemiological studies referred to in the introduction, such as those showing strong relationships with sociopolitical factors as well as socioeconomic conditions. theory x-theory y (table . ), developed by clinical psychologist and professor of management douglas mcgregor in the s, examined two extremes in management assumptions about human nature that ultimately affect the operations of organizations. organizations with centralized decision-making, a hierarchical pyramid, and external control are based on certain concepts of human nature and motivation. mcgregor's theory, drawing on maslow's hierarchy of needs, describes an alternative set of assumptions that credit most people with the capacity for self-direction. traditional approaches to organization and management stress direction and external control. theory x assumes that workers are lazy, unambitious, uncreative, and motivated only by basic physiological needs or fear. theory y places stress on integration and self-control. this model provides a more optimistic leadership model, emphasizing management development programs and promoting human potential, assuming that, if properly motivated, people can be self-directed and creative at work, and that the role of management is to unleash this potential in workers with performance appraisal. many other theories of motivation and management have been developed to explain human behavior and how to utilize inherent skills to produce a more creative work environment, reduce resistance to change, reduce unnecessary disputes, and ultimately create a more effective organization. variants of the human motivation approach in management carried the concept further by examining industrial organization to determine the effects of management practices on individual behavior and personal growth within the work environment. they describe two contrasting models of workforce motivation. theory x assumes that management produces immature responses on the part of the worker: passivity, dependence, erratically shallow interests, shortterm perspective, subordination, and lack of self-awareness. in contrast, at the other end of the immaturity-maturity spectrum was the mature worker, with an active approach, an independent mind capable of a broad range of responses, deeper and stronger interests, a long-term perspective, and a high level of awareness and self-control. this model has been tested in a variety of industrial settings, showing that giving workers the opportunity to grow and mature on the job helps them to satisfy more than basic survival needs and allows them to use more of their potential in accomplishing organizational goals. this model became widely influential in human resource management theory of organizational behavior, organizational communication, and organizational development, and in the practical management of business and service enterprises. in the motivation to work ( ) , us clinical psychologist frederick herzberg wrote of his motivationhygiene theory. he developed this theory after extensive studies of engineers and accountants, examining what he called hygiene factors (i.e., administrative, supervisory, monetary, security, and status issues in work settings). his motivating factors included achievement, recognition of accomplishment, challenging work, and increased responsibility with personal and collective growth and development. he proved that the motivating factors had a substantial positive effect on job satisfaction. these human resource theories of management helped to change industrial approaches to motivation from "job enrichment" to a more fundamental and deliberate upgrading of responsibility, scope, and challenge of work, by letting workers develop their own ways of achieving objectives. even when the theories were applied to apparently unskilled workers, such as plant janitors, the workers changed from an apathetic, poorly performing group into a cohesive, productive team, taking pride in their work and appearance. this approach gave members of the team the opportunity to meet their human self-actualization needs by taking greater responsibility for problem solving, and it resulted in less absenteeism, higher morale, and greater productivity with improved quality. rensis likert, with mcdougal and herzberg, helped to pioneer the "human relations school" in the s, applying human resource theory to management systems and styles. likert classified his theory into four different systems, as follows. l system -management has no confidence or trust in subordinates, and avoids involving them in decisions and goal setting, which are made from the top down. management is task oriented, highly structured, and authoritarian. fear, punishment, threats, and occasional rewards are the principal methods of motivation. worker-management interaction is based on fear and mistrust. informal organizations within the system often develop that lead to passive resistance of management and are destructive to the goals of the formal organization. l system -management has a condescending relationship with subordinates, with some degree of trust and confidence. most decisions are centralized, but some decentralization is permitted. rewards and punishments are used for motivation. informal organizations become more important in the overall structure. l system -management places a greater degree of trust and confidence in subordinates, who are given a greater degree of decision-making powers. broad policy remains a centralized function. l system -management is seen as having complete confidence in subordinates. decision-making is dispersed, and communication flows upward, downward, and laterally. economic rewards are associated with achieving goals and improving methods. relationships between management and subordinates are frequent and friendly, with a sense of teamwork and a high degree of mutual respect. case studies showed that a shift in management from likert system towards system radically changed the performance of production, cut manufacturing costs, reduced staff turnover, and increased staff morale. furthermore, workers and managers both shared a concern for the quality of the product or service and the competitiveness and success of their business. the health industry includes highly trained professionals and paraprofessional workers who function as a team with a high degree of cohesion, mutual dependence, and autonomy, such as a surgical or an emergency department team. the network, or task-oriented working group, is basically a more democratic and participatory form of organization meant to elicit free interchange of concerns and ideas. this is a more organic form of organization, best suited to be effective for adaptation when the environment is complex and dynamic, when the workforce is largely professional, and when the technology and system functions change rapidly. complexities and technological change require information, expertise, flexibility, and innovation, strengths best promoted in free exchange of ideas in a mutually stimulating environment. in a network organization, leadership may be formal or informal, assigned to a particular function, which may be temporary, medium term, or permanent, to achieve a single defined task or develop an intersectoral program. the task force is usually for a short-term specific assignment; a working group, often for a medium-term project, such as integrating services of a region; and a committee for permanent tasks such as monitoring an immunization program. significant advantages of this form of organization are the challenge and the sharing of information and responsibility, which give professionals responsibility and job satisfaction by providing the opportunity to demonstrate their creativity. members of the task force may each report within their own pyramidal structure, but as a group they work to achieve the assigned objective. they may also be interdisciplinary or interagency working groups to review the state of the art in this particular issue as documented in reports and professional literature, and to coordinate activities, review previous work, or plan common future activities. an ongoing network organization may be a government cabinet committee to coordinate government policy and the work of various government departments, or a joint chiefs of staff to coordinate the various armed services. this approach is commonly used for task groups wherein interdisciplinary teams of professionals meet to coordinate functions of a department in a hospital, or where a multidisciplinary group of experts is established with the specified task of a technical nature. network organizational activity is part of the regular functions of a health professional. informal networking is a day-to-day activity of a physician in consultations with colleagues and also a part of more formalized network groups. the hospital department must, to a large extent, function as a network organization with different professionals working as a team more effectively than would be possible in a strictly authoritarian pyramidal model. a ministry of health may need to develop a joint working group with the ministry of transport, the police, and those responsible for standards of motor vehicles to seek ways to reduce road accident deaths and injuries. if a measles eradication project is envisioned, a multidisciplinary and multiorganizational team, or a network, should be established to plan and carry out the complex of tasks needed to achieve the target (figure . ) . in a public health context, a task group to determine how to reduce obesity rates in school-aged children, or to eradicate measles locally, might be chaired by the deputy chief medical officer or senior health promotion person; if the project is reduction of obesity among school children, the lead agency may be the department of education, perhaps jointly with the local department of health; if reduction in road traffic deaths is the topic, the lead may be the police department with participation of emergency transportation and hospital emergency room lead personnel. members may include the chief district nurse, an administrative and budget officer, a pharmacist, the chief of the pediatric department of the district hospital, a primary school administrator, a health educator, a medical association representative, the director of laboratories, the director of the supply department, a representative of the department of education, representatives of voluntary organizations interested in the topic, and others as appropriate. most organizational structures are mixed, combining elements of both the formal pyramidal and the less structured network structure with a task-oriented mandate. it is often difficult for a rigid pyramidal structure to deal with parallel bodies in a structured way, so the network approach is necessary to establish working relations with outside bodies to achieve common goals. a network is a democratic functional grouping of those professionals and organizations needed to achieve a defined target, sometimes involving people from many different organizations. the terms of reference of the working group are crucial to its function as well as its composition, time-frame, and access to relevant information. the application of this concept is increasingly central in health care organization as multilevel health systems evolve in the form of managed care or district health systems. these are vertically integrated management systems involving highly professional teams and units whose interdependence for patient care and financial responsibility are central elements of the new public health. in the usa during world war ii, w. edwards deming, a physicist and statistician, developed a system of economic and statistical methods of quality control in production industries. following the war, deming was invited to teach in japan and moved from the university to the level of industrial management. japanese industrialists adopted his principles of management and introduced quality management into all industries, with astonishingly successful results within a decade. the concept, later called total quality management (tqm), has since been adopted widely in production and service industries. in the deming approach to company management, quality is the top priority and is the key responsibility of management, not of the workers. if management sets the tone and involves the workers, quality goes up, costs come down, and both customer satisfaction and loyalty increase. having their ideas listened to, and avoiding a punitive inspection approach, enhances the pride of the workers. it is the responsibility of leadership to remove fear and build mutual participation and common interest. training is one of the most important investments of the organization. the differences between traditional management and the tqm approach are shown in boxes . and . . in societies with growing economies, the role of an educated workforce becomes greater as information technology and services, such as health, become larger parts of the economy and require professionalism and self-motivating workers. the tqm approach integrates the scientific management and human relations approaches by giving workers credit for intellectual capacity and expects them to use it to analyze and improve the tasks they perform. even more, this approach expects workers at all levels to contribute to better quality in the process of design, manufacture, and even marketing of the product or the service. the tqm ideas were revolutionary and successful when applied in business management in production industries. the tqm concept is much in discussion in the service industries. the who has adapted tqm to a model called continuous quality improvement (cqi), with the stress on mutual responsibilities throughout a health system for quality of care. the application of tqm and cqi approaches is discussed in chapter , including the external regulatory and self-development tqm approaches. in the health sector, issues such as prevention of health facility-acquired infections require staff dedicated to promoting a culture of cleaning, frequent and thorough hand washing, sterilization, isolation techniques, intravenous and intratracheal catheter and tube care technique, and immunization of hospital personnel. these and many other crossdisciplinary measures promote patient safety and prevent the costly and frequently deadly effects of serious respiratory or urinary tract injection acquired in hospitals or other health care facilities. human behavior is individual but takes place in a social context. changes to individual behavior are needed to reduce risk factors for many diseases. change can be threatening; it requires alteration, substitution, transformation, or modification of purposes, procedures, methods, or style. the implementation of plans usually requires some change, which often meets resistance. the resistance to change may be professional, technical, psychological, political, emotional, or a mix of all of these. the manager of a health facility or service has to cope with change and gather the support of those involved to participate in creating or implementing the change effectively. the behavior of the worker in a production or service industry is vital to the success of the organization. equally important is the behavior of the purchaser or consumer of the product or service. diagnosing organizational problems is an important skill to bring to leadership in health systems. even more important is the ability to identify and alter the variables that require change and adaptation to improve the performance of the organization. high expectations are essential to produce high performance and improved standards of service or productivity. conversely, low expectations not only lead to low performance, but produce a downward spiraling effect. this applies not only within the organization, but to the individuals and community served, l judgment, punishment, and reward for above-or belowaverage performance destroy teamwork essential for quality production. l work with suppliers to improve quality and costs. l profits are generated by loyal customers -running a company for profit alone is like driving a car by looking in the rearview mirror. whether in terms of purchase of goods produced or in terms of health-related behavior. people often resist change because of fear of the unknown. participation in the process of defining problems, formulating objectives, and identifying alternatives is needed to bring about changes. change in organizational performance is complex, and this is the test of leadership. similarly, change at the individual level is essential to achieve the goals of the group, whether this is in terms of the functioning of a health care service unit, such as a hospital, or whether it is an individual's decision to change from smoking to non-smoking status. the health of both an individual and a population depends on the individual health team member's motivation and experience. the behavior of the individual is important to his or her personal and community health. even small steps in the direction of a desirable change in behavior should be rewarded as soon as possible (i.e., reinforcing positive performance in increments). behavior modification is based on the concept that change of behavior starts with the feelings and attitudes within the individual, but can be influenced by knowledge, peer pressure, media coverage, and legislative standards. change involves a number of elements to define a current or previous starting point: change in behavior is vital in the health field: in the organization, in the community, in individual behavior, and in societal regulation and norms. the health belief model (chapter ) is widely influential in psychology and health promotion. the belief intervention approach involves programs meant to reduce risk factors for a public health problem. it may require change in the law and in organizational behavior, with involvement and feedback to the people who determine policy, those who manage services, and the community being served. obesity in school-aged children is being fought by many measures including healthier menus and banning the sale of high sugar drinks on school property. high cholesterol is being fought on many fronts including dietary change and banning the use of transfats in food processing. deaths from bulimia are not uncommon and may stem from teenage identification of beauty with ultrathin body image. banning television and modeling agencies from using models with a very low body mass index is an intervention in advertising which encourages harmful practices that are a danger to health and life. banning cigarette advertising and smoking in public places promotes behavioral change, as does raising the taxes on cigarettes. gun control laws are meant to prevent disturbed individuals or political fanatics having easy access to firearms to commit mass murder. strict enforcement of drinking and driving laws can prevent drunk driving and reduce road traffic deaths (see chapter ). in the s, major industries in the usa were unable to compete successfully with the japanese in the consumer electronics and automobile industries. management theory began to place greater emphasis on empowerment as a management tool. the tqm approach stresses teamwork and involvement of the worker in order to achieve better quality of production. comparatively, empowerment went further to involve the worker in operation, quality assessment, and even planning of the design and production process. results in production industries were remarkable, with increased efficiency, less absenteeism, and greater searching for ideas to improve quality and quantity of production, with the worker as a participant in the management and production process. the concept of empowerment entered the service industries with the same rationale. the rationale is that improvements in quality and effectiveness of service require the active physical and emotional participation of the worker. participation in decision-making is the key to empowerment. this requires management to adopt new methods that allow the worker, whether professional or manual, to be an active participant. successful application of the empowerment principles in health care extends to the patient, the family, and the community, emphasizing patients' rights to informed participation in decisions affecting their medical care, and the protection of privacy and dignity. diffusion of powers occurs when management of services is decentralized. delegation of powers to professional groups, non-governmental organizations (ngos), and advocacy organizations is part of empowerment in health care organizations. governmental powers to govern or promote areas such as licensure, accreditation, training, research, and service can be devolved to local authorities or ngos by delegation of authority or transfer of funds. organizational change may involve decentralization. institutional changes such as amalgamation of hospitals, long-term care facilities, home care programs, day surgery, ambulatory care, and public health services are needed to produce a more effective use of resources. integration of services under community leadership and management should encourage transfer of funds within a district health network from institutional care to community-based care. such changes are a test of leadership skills to achieve cultural change within an organization, which requires behavioral change and involvement of health workers in policy and management of the change process. strategic management emphasizes the importance of positioning the organization in its environment in relation to its mission, resources, consumers, and competitors. it requires development of a plan of action or implementation of a strategy to achieve the mission or goal of the organization within acceptable ethical and legal guidelines. articulation of these is a key role of the management level of an organization. defining the mission and goals of the organization must take into account the external and internal environment, resources, and operational needs to implement and evaluate the adequacy of the outcomes. the strategy of the organization matches its internal approach with external factors, such as consumer attitudes and competing organizations. strategy is a set of methods and skills of the health care manager to attain the objectives of a health organization, including: policy is the formulation of objectives and priorities. strategy refers to long-range plans to achieve stated objectives, indicating the problems to be expected and how to deal with them. strategy does not identify all actions to be taken, but it includes evaluation of progress made towards a stated goal. while the term has traditionally been used in a military context, it has become an essential concept in management, whether of industry, business, or health care. tactics are the methods used to fulfill the strategy. thus, strategic mbo is applicable to the health system, incorporating definitions of goals and targets, and the methods to achieve them (box . ). change in health organizations may involve a substantial alteration in the size or relationships between existing, well-established facilities and programs (table . ). a strategic plan for health reform in response to the need for cost containment, redefined health targets, or dissatisfaction with the status quo requires a model or a vision for the future and a well-managed program. opposition to change may occur for psychological, social, and economic reasons, or because of fear of loss of jobs or changes in assignments, salary, authority, benefits, or status. downsizing in the hospital sector, with buildup of community health services, is one of the major issues in health reforms in many countries. it can be accomplished over time by naturally occurring vacancies or attrition due to retirement, or by retraining and reassignment, all of which require skilled leadership. the introduction of new categories of health workers in hospitals such as phlebotomists, hospitalist doctors, and technicians of all kinds has improved hospital efficiency and safety. community health has benefited from home care and in many situations community health workers to assist and supervise patient care in remote rural villages and in urban centers, even in high-income countries, with health guides trained to help people to function with chronic illnesses and dementias (see chapter ). the new public health is an integration or coordination of many participating health care facilities and health-promoting programs. it is evolving in various forms in different places as networks with administrative and financial interaction between participating elements. each organization provides its own specific services or groups of services. how they function internally and how they interact functionally and financially are important aspects of the management and outcomes of health systems. the health system functions as a network with formal and informal relationships; it may be very broad and loosely connected as in a highly decentralized system, with many lines of communication, payment, regulation, standards setting, and levels of authority. the relationship and interchange between different health care providers have functional and economic elements. as an example, an educated adult woman is more likely than an uneducated woman to prepare herself for the requirements of pregnancy by smoking and alcohol or drug cessation, folic acid intake, healthful diet, and attending professional antenatal care. a pregnant woman who is healthy and prepared for pregnancy physically and emotionally, and who receives comprehensive prenatal care, is less likely than a woman whose health is neglected to develop complications and require prolonged hospital care as a result of childbirth. the cost of good prenatal care is a fraction of the economic cost of treating the potential complications and damage to her health or that of the newborn. a health system is responsible for ensuring that a woman of reproductive age takes folic acid tablets orally before becoming pregnant, has had access to family planning services so that the pregnancy is a desired one, ensures that the space between pregnancies is adequate for her health and that of her baby, and receives adequate prenatal care. an obstetrics department should be involved in assuring or providing the prenatal care, especially for high-risk cases, and delivery should be in hygienic and professionally supervised settings. similarly, for children and elderly people, there is a wide range of public health and personal care services that make up an adequate and cost-effective set of services and programs. the economic burden of caring for the sick child falls on the hospital. when there is a per capita grant to a district, the hospital and the primary care service have a mutual interest in reducing morbidity and hence mortality. this is the principle of the hmos and district health systems discussed elsewhere. it is also a fundamental principle of the new public health. health care organizations differ according to size, complexity, ownership, affiliations, types of services, and location. traditionally, a health care organization provides a single type of service, such as an acute care hospital providing episodic inpatient care, or a home health care agency. in present-day health reforms, health care organizations, such as an hmo or a district health system, provide a populationbased, comprehensive service program. each organization must have or develop a structure suited to meet its goals, in both the internal and external environments. the common elements that each organization must deal with include governance of policy, production or service, maintenance, financing, relating to the external environment, and adapting to changing conditions. a functional model of an organization perhaps best suited to the smaller hospital is the division of labor into specific functional departments; for example, medical, nursing, administration, pharmacy, maintenance, and dietary, each reporting through a single chain of command to the chief executive officer (ceo) (figure . ) . the governing agency, which may be a local non-profit board or a national health system, has overall legal responsibility for the operation and financial status of the hospital, as well as raising capital for improvements. the medical staff may be in private practice and work in the hospital with their own patients by application for this right as "attending physician", according to their professional qualifications, or the medical staff may be employed by the hospital in a similar way to the rest of the staff. salaried medical staff may include physicians in administration, pathology, anesthesia, and radiology, so that even in a private practice market system many medical staff members are hospital employees. increasingly, hospitals are employing "hospitalists", who are full-or part-time physicians whose work is in the health facility, to provide continuity of inpatient and emergency department services, augmenting the services of senior or attending staff or private practice physicians. this shift is in part related to the increasing numbers of female physicians who run their homes and families as well as practice medicine and who find this mode of work more attractive than full-time private practice. this model is the common arrangement in north american hospitals. the governing board of a "voluntary", nongovernmental, not-for-profit organization with municipal and community representatives may be appointed by a sponsoring religious, municipal, or fraternal organization. the corporate model in health care organization (figure . ) is often used in larger hospitals or where mergers with other hospitals or health facilities are taking place. the ceo delegates responsibility to other members of the senior management team who have operational responsibility for major sectors of the hospital's functioning. a variation of the corporate model is the divisional model of a health care organization based on the individual service divisions allowing middle management a high degree of autonomy (figure . ). there is often departmental budgeting for each service, which operates as an economic unit; that is, balancing income and expenditures. each division is responsible for its own performance, with powers of strategic and operational decision-making authority. this model is used widely in private corporations, and in many hospitals in the usa. with increasing complexity of services, it is also employed in corporate health systems in the usa, with regional divisions. the matrix model of a health care organization is based on a combination of pyramidal and network organization. this model is suited to a public health department in a state, county, or city. individual staff people report in the pyramidal chain of command, but also function in multidisciplinary teams to work on specific programs or projects. a nutritionist in the geriatric department is responsible to the chief of nutrition services but is functionally a member of the team on the geriatric unit. in a laterally integrated health maintenance organization or district health system, specialized staff may serve in both institutional (i.e., hospital) and community health roles (figure . ) . the organizational structure appropriate to one set of circumstances may not be suitable for all. whether the payment system is by norm (i.e., by predetermined numbers of staff, their salaries, and fixed costs for all services), per diem (i.e., payment of a daily rate times the number of days of stay), historical budget, or per capita in a regional or district health system structure (see chapters and ), the internal operation of a hospital will require a model of organization appropriate to it. hospitals need to modify their organizational structure as they evolve, and as the economics of health care change. leadership in an organization requires the ability to define the goals or mission of the organization and to develop a strategy and define steps needed to achieve these goals. it requires an ability to motivate and engender enthusiasm for this vision by working with others to gain their ideas, their support, and their participation in the effort. in health care as in other organizations, it is easier to formulate plans than to implement them. change requires the ability not only to formulate the concept of change, but also to modify the organizational structure, the budgeted resources, the operational policies and, perhaps most importantly, the corporate culture of the organization. management involves skills that are not automatically part of a health professional's training. skilled clinicians often move into positions requiring management skills in order to build and develop the health care infrastructure. in some countries, hospital managers must be physicians, often senior surgeons. clinical capability does not transfer automatically into management skills to deal with personnel, budgets, and resources. therefore, training in management is vital for the health professional. the manager needs training for investigations and factfinding as well as the ability to evaluate personnel, programs, and issues, and set priorities for dealing with the short-and long-term issues. negotiating with staff and outside agencies is a constant activity of the manager, ranging from the trivial to major decisions with wide implications. perhaps the most crucial skill of the manager is communication: the ability to convey verbal, written, or unwritten messages that are received and understood and to assess the responses as an equal part of the exchange. interpersonal skills are a part of management practice. the capable manager can relate to personnel at all levels in an open and equal manner. this skill is essential to help foster a sense of pride and involvement of all personnel in working towards the same goals and objectives, and to show that each member of the team is important to meeting the objectives of the organization. at the same time, the manager needs to communicate information, especially as to how the organization is doing in achieving its objectives. the manager is responsible for organizing, planning, controlling, directing, and motivating. managers assume multiple roles. a role is an organized set of behaviors. henry mintzberg described the roles needed by all managers: informational, interpersonal, and decisional roles. robert katz ( ) identified three managerial skills that are essential to successful management: technical, human, and conceptual: "technical skill involves process or technique knowledge and proficiency. managers use the processes, techniques and tools of a specific area. human skill involves the ability to interact effectively with people. managers interact and cooperate with employees. conceptual skill involves the formulation of ideas. managers understand abstract relationships, develop ideas, and solve problems creatively". technical skill deals with things, human skill concerns people, and conceptual skill has to do with ideas. the distribution of these skills between the levels of management is shown in figure . . hospital directors in the past were often senior physicians, often called superintendents, without training in health management. the business manager ceo has become common in hospital management in the usa. during the s, the ceo was called an administrator, and worked under the direction of a board of trustees who raised funds, set policies, and were often involved in internal administration. where the ceo was a non-physician, the usual case in north american hospitals, a conflict often existed with the clinical staff of the hospital. in some settings, this led to appointment of a parallel structure with a full-time chief of medical staff with a focus on clinical and qualitative matters. in european hospitals, the ceo is usually a physician, often by law, and the integration of the management function with the role of clinical chief is the prevalent model. over time, as the cost and complexity of the health system have increased, the ceo role has changed to one of a "coordinator". the ceo is now more involved in external relations and less in the day-to-day operation of the facility. the ceo is a leader/partner but primus inter pares, or first among equals, in a management team that shares information and works to define objectives and solve problems. this de-emphasizes the authoritarian role and stresses the integrative function. the ceo is responsible for the financial management of operational and capital budgets of the facility, which is integral to the planning and future development of the facility. budgets include four main factors: income, fixed or regular overhead, variable or unpredictable overhead, and capital or development costs, all essential to the survival and development of the organization. the key role of top management is to develop a vision, goals, and targets for the institution, to maintain an atmosphere and systems to promote the quality of care, financial solidity, and to represent the institution to the public. the overall responsibility for the function and well-being of the program is with the ceo and the governing board of directors. community participation in management of health facilities has a long-standing and constructive tradition. the traditional hospital board has served as a mechanism for community participation and leadership in promoting health facility development and management at the community level. the role of hospital boards evolved from primarily a philanthropic and fund-raising one to a greater overall responsibility for policy and planning function working closely with management and senior professional staff. this change occurred as operational costs increased rapidly, as government insurance schemes were implemented, and as court decisions defined the liability of hospitals and reinforced the broadened role of governing boards in malpractice cases and quality assurance. centrally developed health systems such as the uk's nhs have promoted district and county health systems with high degrees of community participation and management, both at the district level and for services or facilities. the role of local authorities, as well as state and national governments, is crucial to the functioning of public health in its traditional issues such as safe water supply, sanitation, business licensing, social welfare, and many others, as discussed in chapter . these functions have not diminished with the greater roles of state and federal or national governments in health. in healthful living environments the local authority functions are of continuing and indeed expanding importance, as in urban planning and transportation, promoting easy access to commercial facilities for shopping and healthy food sources for poorer sections as well as those available to prosperous members of the community. advocacy has always been an important part of public health. an illustration of this is seen in box . in changing the law banning birth control in massachusetts in the s. the issue of birth control still casts a heavy burden on women globally owing to religious objections, so this example from the s is still relevant as a political issue both in the usa and in many other countries. community participation can be crucial to the success of an intervention to promote community health. sensitivity to local, religious, or ethnic concerns is part of planning any study or intervention in public health. this does not mean that the national, state, and local health authorities must continuously canvass public opinion, but there is advantage in holding referenda on some issues compared to governmental fiat. the usa has higher rates of fluoridation than most countries, and this is implemented after referenda in each municipality (see chapter ). in portland, oregon, the city council profluoridation vote in (new york times, september ) was later rejected in the public referendum. portland is the only major american city without fluoridation (portland tribune, may ). rationalization of health facilities increasingly means organizational linkages between previously independent facilities. mergers of health facilities are common events in many health systems. in the usa, there are frequent mergers between hospitals, or between facilities linked to hmos or managed care systems. health reform in many countries is based on similar linkages. governmental approval and alteration to financing systems are needed to promote linkages between services to achieve greater efficiency and improve patient care (see chapters and ). lateral integration is the term used for amalgamation among similar facilities. like a chain of hotels, in health care this involves two or more hospitals, usually meant to achieve cost savings, improve financing and efficiency, and reduce duplication of services. urban hospitals, both notfor-profit as well as for-profit, often respond to competition by purchasing or amalgamating with other hospitals to increase market share in competitive environments. this is often easier for hospital-oriented ceos and staff to comprehend and manage, but it avoids the issues of downsizing and integration with community-based services. vertical integration describes organizational linkages between different kinds of health care facilities to form integrated, comprehensive health service networks. this permits a shift of emphasis and resources from inpatient care to long-term, home, and ambulatory care, and is known as the managed care or district health system model. community interest is a factor in promoting change to integrate services, which can be a major change for the management culture, especially of the hospital. the survival of a health care facility may depend on integration with appropriate changes in concepts of management. in the s, a large majority of california residents moved to managed care programs because of the high cost of fee-for-service indemnity health insurance and because of federal waivers to promote managed care for medicare and medicaid beneficiaries. independent community hospitals without a strong connection to managed care organizations (mcos) were in danger of losing their financial base. hospital bed supplies were reduced in the usa however, the article served to stimulate the legislature to revisit the law, leading to its repeal in , thus allowing use of all methods of birth control. the controversy subsided and women were free to control their own fertility as a result of this advocacy. by diagnosis-related group (drg), rather than on a per diem basis. similar trends are seen in european countries, although in the commonwealth of independent states the number of hospital beds declined between and - but stabilized at high and inefficient levels ( beds per population) compared to the number in western europe, which fell from beds per in to . in , and in some countries to per population despite increased longevity and aging of the population. there was a shift to stronger ambulatory care, as occurred throughout the industrialized countries despite an aging of the population. these trends were largely due to greater emphasis on ambulatory surgery and other care, and major medical centers responded with strategic plans to purchase community hospitals and develop affiliated medical groups and contract relationships with managed care organizations to strengthen their "market share" service population base for the future. the new payment environment and managed care also promoted hospital mergers (lateral integration) and linkages between different levels of service, such as teaching hospitals with community hospitals and primary community care services (vertical integration). vertical integration not only is important in urban areas, but can serve as a basis for developing rural health care in both developed and developing countries. the district hospital and primary care center operating as an integrated program can provide a high-quality program. hospitalcentered health care, common in industrialized countries, has traditionally channeled a high percentage of total health expenditures into hospital services. over recent years, there has been a reduction in hospital bed supply in most industrialized countries, with shorter length of stay, more emphasis on ambulatory care, improved diagnostic facilities, and improved outcomes of care (see chapter ). expenditures on the hospital component of care have come down to between and percent of total health expenditures in many countries, with a growing proportion going to ambulatory and primary care, and increased percentages to public health. this shift in priorities has been an evolutionary process that will continue, but requires skilled management leadership, grounded in health systems management training and epidemiological knowledge, and skilled negotiating skills to foster primary care and health promotion approaches both within the organization and in relation to outside services, especially preventive services. this shift in policy direction will be fostered in implementation of the ppaca (obamacare), discussed in chapters and . managed care systems or accountable care organizations (acos) will integrate hospital and community care and try to limit hospital care by strengthening ambulatory and primary care, and especially preventive care. this will have both economic and epidemiological benefits, but will depend on skilled management to understand and lead in their implementation. much of the rationale for these changes is discussed in the literature and summarized in a report from the us institute of medicine, entitled "best care at lower cost". this report calls for overhauling the health system in a continuous evolution based on evidence and lessons learned from decades of innovative care systems and research into their workings. the health system needs to relate to other community services with a shared population orientation (institute of medicine, ). norms are useful to promote efficient use of resources and promote high standards of care, if based on empirical standards proved by experience, trial and error, and scientific observation. norms may be needed even without adequate evidence, but should be tested in the reality of observation, experience, and experiment. this process requires data for selected health indicators and trained observers free to examine, report, and publish their findings for open discussion among colleagues and peers in proceedings open to the media and the general public. normative standards of planning are the determination of a number per unit of population that is deemed to be suitable for population needs; for example, the number of beds or doctors per population or length of stay in hospital. many organizations based on the bureaucratic model used norms as the basis for planning and allocation of resources including funding (see chapter ). this led to payment systems which encouraged greater use of that resource. if a factory is paid by the number of workers and not the number and quality of the cars produced, then management will have no incentive to introduce efficiency or quality improvement measures. if a district or a hospital is paid by the number of beds, or by days of care in the hospital, there is no incentive to introduce alternative services such as same-day or outpatient surgery and home care. performance indicators are measures of completion of specific functions of preventive care such as immunization, mammography, pap smears, and diabetes and hypertension screening. they are indirect measures of economy, efficiency, and effectiveness of a service and are being adopted as better methods of monitoring and paying for a service, such as by paying a premium. general practitioners in the uk receive additional payments for full immunization coverage of the children registered in their practices. a block grant or per capita sum may be tied to indicators that reflect good standards of care or prevention, such as low infant, child, and maternal mortality. incentive payments to hospitals can promote ambulatory services as alternatives to admissions and reduce lengths of stay. limitations of financial resources in the industrialized countries and even more so in the developing countries make the use of appropriate performance indicators of great importance in the management of resources. pay-for-performance is a system of paying for health services developed in the uk for paying general practitioners, with apparently satisfactory results. it is now widely used in the usa. it is defined as "a strategy to improve health care delivery that relies on the use of market or purchaser power. agency for healthcare research and quality (ahrq) resources on pay for performance (p p), depending on the context, refers to financial incentives that reward providers for the achievement of a range of payer objectives, including delivery efficiencies, submission of data and measures to payer, and improved quality and patient safety" (agency for healthcare research and quality, ) . more than half of commercial hmos are using pay-for-performance. recent legislation requires the medicare and medicaid programs to adopt this approach for beneficiaries and providers. as commercial programs have evolved during the past years, the categories of providers (clinicians, hospitals, and other health care facilities), number of measures, and dollar amounts at risk have increased. this method of payment is likely to be promoted in the affordable care act implementation to improve quality and control cost increases in us health care (see chapters , , and ). payfor-performance has also been adopted in other countries trying to improve quality of care, such as macedonia (lazarevik and kasapinov, ) . social marketing is the systematic application of marketing alongside other concepts and techniques to achieve specific behavioral goals for a social good. initially focused on commercial goals in the s, the concept became part of health promotion activities to address health issues where there was no current biomedical approach, such as in smoking reduction and in safe sex practices to prevent the spread of hiv. social marketing was based initially on commercial marketing techniques but now integrates a full range of social sciences and social policy approaches using the strong customer understanding and insight approach to inform and guide effective policy and strategy development. it has become part of public health practice and policy setting to achieve both strategic and operational targets. a classic example of the success is seen with tobacco reduction strategies in many countries using education, taxation, and legislative restrictions. other challenges in this field include risk behavior such as alcohol abuse through binge drinking, unsafe sex practices, and dietary practices harmful to health. philanthropy and volunteerism have long been important elements of health systems through building hospitals, mission houses, and food provision, and other prototype initiatives on a demonstration basis. this approach has been instrumental in such areas as improved care and prevention of hiv, immunization in underdeveloped countries, global health strategies, and maternal and child health services. during the late twentieth and early twenty-first centuries, a new "social entrepreneurship" was initiated and developed by prominent reform-minded former us president bill clinton, microsoft's bill gates, and the open society institute of george soros. the rotary club international has been a major factor in funding and promoting the global campaign to eradicate poliomyelitis. this has promoted integration and consortia for the promotion of acquired immunodeficiency syndrome (aids) prevention and malaria control in many developing countries. the global alliance for vaccine and immunization (gavi) is a us-based organization which links international public and private organizations and resources to extend access to immunization globally. it includes the united nations children's fund (unicef), who, bilateral donor countries, the vaccine industry, the gates foundation, and other major donors. gavi has made an important contribution to advancing vaccine coverage and adding important new vaccines in many developing countries and regions. these organizations focus funds and activities on promoting improved care and prevention of hiv, tuberculosis, and malaria, along with improved vaccination for children, reproductive health, global health strategies, technologies, and advocacy. these programs generate publicity and raise consciousness at political levels where resource allocations are made. a central feature of these programs is the promotion of "civil society" as active partners in a globalized world of free trade, democracy, and peace. specific initiatives included promoting improved largescale marketing of antiretroviral drugs for the treatment of hiv infection, including price reduction so that developing countries can offer antiretroviral treatment, especially to reduce mother-to-infant transmission. programs have branched out into the distribution of malaria-preventing bed nets, provision of low-cost pharmaceuticals, marketing drugs for the poor, desalination plants, solar roof units, lowcost small loans, and cell phones, mainly in africa. another form of social entrepreneurship that has gained support in the private sector is proactiveness in environmental consciousness to address issues raised by the environmental movement, and public interest for environmental accountability. the automobile industry is facing both public concern and federal legal mandates for improved gas mileage as opposed to public demand for larger cars. hybrid cars using less fuel have been successfully introduced into the market for low-emission, fuel-efficient cars, and electric cars are gradually entering the field. public opinion is showing signs of moving towards promoting environmentally friendly design, marketing, and purchasing practices in energy consumption, conservation practices, and public policy. public opinion and the price of fuel will play a major part in driving governments to legislate energy and conservation policies to address global warming and damage to the environment, with their many negative health consequences. however, such changes must work with public opinion because of the sensitivity of consumers to the price of fuel. in addition, when food crops, such as corn, are used to produce ethanol for energy to replace oil, then food prices rise and consumers suffer and respond vigorously. corporations adopt policies of environmental responsibility in part because of public relations and partly because of potential liability claims. much of the planning and financial costs of offshore petroleum and gas drilling is spent on safety measures to protect the environment. the explosion in at a british petroleum site in the gulf of mexico, off the coast of texas and louisiana, caused massive pollution and environmental damage, and resulted in the us government being awarded us$ . billion against bp for cleanup and damages. the reputation of the corporation suffered and some executive officers lost their positions. thus, corporate social responsibility can be seen as self-interest. new models of health care organization are emerging and developing rapidly in many countries. this is partly a result of a search for more economical methods of delivering health care and partly the result of the target-oriented approach to health planning that seeks the best way to define and achieve health objectives. the developed countries seek ways to restrain cost increases, and the developing countries seek effective ways to quickly and inexpensively raise health standards for their populations. new organizational models that try to meet these objectives include district health systems, managed care organizations (mcos) and accountable care organizations (acos), described in greater detail in chapter . critical and basic elements of a health system organization are shown in figure . . new initiatives are part of the growth and development of any organization or health service system, as needs, technologies, resources, and public demand change. identification of issues and decisions to launch new endeavors or projects to advance the state of the art, to address unmet needs, or to meet competition are part of organizational responsibility, in the public sector to meet needs, and in the private sector to remain competitive. in developing and developed countries, many ngos provide funding from abroad for essential services that a government may be unable to provide. such projects focus on issues directed from the head offices in the usa or europe of the funding source or management offices for specific vertical programs which are often not fully integrated with national priorities and programs. however, these need coordination and approval by the local national government agency responsible for that sector of public service. new projects run by ngos may run in parallel to each other, or to state health services as uncoordinated activities. governmental public health agencies have responsibility for oversight of health systems and can play a leadership and regulatory role in coordinating activities and directing new programs to areas of greatest national need. the public health agency may also seek funding to launch new pilot or specific needs programs. the agency may introduce a new vaccine into a routine immunization program in phases, pending government approval and funding to incorporate it as a routine immunization program based on evaluation of the initial phase. an example is the introduction of haemophilus influenzae type b vaccine in albania in , which was funded by gavi for years based on a study and proposal including a cost-effectiveness study (bino s, ginsberg g, personal communication, ) . proposals for health projects by ngos or private agencies need to be prepared in keeping with the vision, mission, and objectives of the responsible governmental agency, with ethics review and community participation. a project proposal should include why the project is important, its specific goals and objectives, available or new resources, and the time-frame required to achieve success (box . ). it should describe the means proposed to accomplish the goals, and how the proposed program will impact the community, providing recommendations for follow-up and/or further action. the introduction of the project proposal outlines the current state of the problem and the case for action. it should describe existing programs which address that issue, with proposed collaboration, and expansion or improvement of programs, but avoiding duplication of services. background information needs to relate the project to the priorities of the prospective funding organization. the objectives should follow the acronym "smart": specific, measurable, achievable, relevant, and time-based. this term, originally used for computer disc self-management, has been adapted as a current form of mbo from the s and s. the project objectives should be feasible and the expected results of the project should be based on the stated objectives. organizations: behavior, structure, process. new york: mcgraw-hill/ irwin; . the proposed funding agency expects convincing evidence of how this program will be effective, efficient, practical, and realistic. this information is presented in the activities section, which also needs to address the resources that will be needed to implement the program such as the budget for staff, supervison, training, management, materials (vaccines, syringes, equipment, ongoing supplies and others), transportation, and costs of premises. after completing the activities section, a realistic and achievable work plan and time-frame are required. well-planned projects have monitoring and evaluation criteria. monitoring follows the performance of the program, documenting successes, failures, and lessons learned, as well as expenditures. evaluation guidelines of the program define the methods used to assess the impact of the project and whether the project was carried out in an effective and efficient manner, and may be required periodically throughout the life of the project. the most difficult issue is sustainability. a project funded by an ngo is usually time limited to - years and the survival of the program usually depends on its acceptability and the capacity of government to continue it. thus, evaluation becomes even more crucial for the follow-up of even successful short-term projects. harm reduction programs include tackling hiv in drug users, reducing maternal-child hiv transmission, tobacco control programs, and reducing levels of obesity in schoolchildren. sustainability and diffusion of positive findings to wider application are important challenges, especially to global health. even in high-income countries, diffusion of best practices is often slow and fraught with controversy and inertia. examples of this slow or non-diffusion of evidence-based public health include the failure of most european countries to harmonize salt fortification with iodine or total indifference to flour fortification with folic acid to prevent neural tube defects (see chapters and ). public health work within departments or ministries of health or local health authorities operates at a disadvantage in comparison with other health activities, especially hospitals, pharmaceuticals, diagnostics, and medical care. the competition for resources in a centrally funded system is intense, and the political and bureaucratic battles for funds may pit new immunization agents or health promotion programs against new cancer treatment drugs or scanners, and this is very often a difficult struggle. the presentation of program proposals for new public health interventions requires skill, professionalism, good timing, and the help of informed public and professional opinion. allocation of resources is decided at the political level in a tax-based universal system, while even in a social security (bismarckian) system where funding is through an employee-employer payroll deduction, additional funding from government is essential to keep up with the continuing flow of new modalities of treatment or prevention. public health is handicapped in portraying the costs and benefits of important interventions, leaving new programs with insufficient resources, including the staffing and administrative costs (e.g., office space, phone service, transportation costs), which are essential parts of any public health program. portraying the cost of the new proposed program should be based on the total population served, not just the specific target population for a new program; that is, it should be represented as a per capita cost. similarly, projected benefits should extrapolate the results from other areas, such as pandemic or avian flu or severe acute respiratory syndrome (sars), and the likely impact on the target geographic area and its population. public health has prime responsibility for monitoring the health status of the population as well as in preventing infectious and non-communicable diseases and injuries, preparing for disasters, and many other functions. this role requires an adequate multidisciplinary workforce with high levels of competencies. this topic is discussed extensively in chapter . canada's experience with the sars epidemic in led to a reappraisal of public health preparedness and standards. this, in turn, led to the establishment of the national public health agency of canada, which is mandated to develop standards and practices to raise the quality of public health in the country and especially to prepare for possible pandemics. the agency issued standards of competency for public health personnel and fostered the development of regional laboratories, and schools of public health were developed across canada. core competencies for program planning implementation and evaluation are seen in box . . health care systems throughout the world are being scrutinized because of their growing costs in relation to national wealth. at the same time, techniques for evaluating health care with respect to appropriateness, quality, and resource allocation are being developed. these techniques are multifactorial since they must relate to all aspects of health care, including the characteristics of the population being served; available health care resources; measures of the process and utilization of care; measures of health care outcomes; peer review, including quality assessment of health care providers; consumer attitudes, knowledge, and compliance; care provided for "tracer" or sample conditions; and economic cost-benefit studies. evaluation in health care assumes that a health care system and the providers of health care within that system are responsible and accountable for the health status of the population. it must, however, recognize that health services are not the sole determinants of health status; social, economic, and cultural factors also play key roles. a comprehensive approach to evaluation in health care is described in chapter . many of the components that are available in health care systems exist, while others that remain to be developed are discussed. evaluation is an integral part of a comprehensive health care system, in that the components of evaluation must be built into any national system. as long as rationality is expected of health care, evaluation is an essential element of the overall system (tulchinsky, ) (see chapter ). the purpose of management in health is the improvement of health, and not merely the maintenance of an institution. separate management of a variety of health facilities serving a community has derived from different historical development and funding systems. in competition for public attention and political support, public health suffers in comparison to hospitals, new technology and drugs, and other competitors for limited resources. the experience of successes in reducing mortality from both non-infectious and infectious conditions comes largely from public health interventions. medical care is also an essential part of public health, so that management and resource allocation within the total health sector are interactive and mutually dependent. the new public health looks at all services as part of a network of interdependent services, each contributing to health needs, whether in hospital care or in enforcing public health law regarding; for example, motor vehicle safety and smoking restriction in public places. separate management and budgeting of a complex of services results in disproportionate funds, staff, and attention being directed towards high-cost services such as hospitals, and fails to redirect resources to more cost-effective and patient-sensitive kinds of services, such as home and preventive care. however, reducing the supply of hospital beds and implementing payment systems with resources for early diagnosis and incentives for short stays have changed this situation quite dramatically in recent decades. the effects of incentives and disincentives built into funding systems are central issues in determining how management approaches problem solving and program planning, and are therefore important considerations in promoting health. the management approach to resolving this dilemma is professional vision and leadership to promote the broader new public health. thus, managers of hospitals and other health facilities need broad-based training in a new public health in order to understand the interrelationships of services, funding, and population health. managers who continue to work with an obsolescent paradigm with the traditional emphasis, regardless of the larger picture, may find the hospital non-competitive in a new climate where economic incentives promote downsizing institutions and upgrading health promotion. defensive, internalized management will become obsolete, while forward-looking management will be the pioneers of the new public health. this may be seen as a systems approach to improve population and individual health, based on strategic planning for immediate needs and adaptation of health systems in the longer term issues in health. examples of national planning that cut across health and social services include national insurance policies and the provision of new services to meet rising needs, as shown for alzheimer's disease, in france since (box . ) and in the usa since (box . ). health care is one of the largest and most important industries in any country, consuming anywhere from to nearly percent of gnp, and still growing. it is a service, not a production industry, and is vital to the health and well-being box . core competencies for program planning, implementation and evaluation management, from policy to operational management of a production or a service system. creative management of health systems is vital to the functioning of the system at the macrolevel, as well as in the individual department or service. this implies effective use of resources to achieve objectives, and community, provider, and consumer satisfaction. these are formidable challenges, not only when money is available in abundance, but even more so when resources are limited and difficult choices need to be made. modern management includes knowledge and skills in identifying and measuring community health needs and health risks. critical needs are addressed in strategic planning with measurable impacts and targets. public health managers should have skills gained in marketing, networking, data management, managing human resources and finance, engaging community partners, and communicating public health messages. many of the methods of management and organization theory developed as part of the business world have become part of public health. these include defining the mission, values and objectives of the organization, strategic planning and management, mbo, human resource management (recognizing individual and professional values), incentives-disincentives, regulation, education, and economic resources. the ultimate mission of public health is the saving of human life and improving its quality, and achieving this efficiently with high standards of professionalism and community involvement. the scope of the new public health is broad. it includes the traditional public health programs, but equally must concern itself with managing and planning comprehensive service systems and measuring their function. the selection of targets and priorities is often determined by the feasible rather than the ideal. the health manager, either at the macrolevel of health or managing a local clinic, needs to be able to conceptualize the possibilities of improving the health of individuals and the population in his or her service responsibility with current and appropriate methods. good management means designing objectives based on a balance between the feasible and the desirable. public health has benefited greatly from its work with the social sciences and assistance from management and systems sciences to adapt and absorb the new challenges and technologies in applied public health. the new public health is not only a concept; it is a management approach to improve the health of individuals and the population. for a complete bibliography and guidance for student reviews and expected competencies please see companion web site at http://booksite.elsevier.com/ bibliography electronic resources glossary of managed care terms national association of public hospitals and health systems world health organization, the health manager's website pay for performance (p p): ahrq resources dr. deming: the american who taught the japanese about quality achieving a high performance health care system with universal access: what the united states can learn from other countries improving the effectiveness of health care and public health: a multi-scale complex systems analysis framework for program evaluation in public health biological and chemical terrorism: strategic plan for preparedness and response. recommendations of the cdc strategic planning workgroup a framework for program evaluation. office of the associate director for program -program evaluation developing leadership skills patterns of ambulatory health care in five different delivery systems capacity planning in health care: a review of the international experience. who, on behalf of the european observatory on health systems and policies strategic management of health care organizations social media engagement and public health communication: implications for public health organizations being truly "social crossing the quality chasm: a new health system for the twenty-first century future of the public's health in the st century best care at lower cost: the path to continuously learning health care in america behavioral interventions to reduce risk for sexual transmission of hiv among men who have sex with men cd . available at the wisdom of teams: creating the high-performance organization social marketing: influencing behaviors for good the interaction of public health and primary care: functional roles and organizational models that bridge individual and population perspectives the powers and pitfalls of the payment for performance three skills every st-century manager needs total quality management as competitive advantage: a review and empirical study making the best of hospital pay for performance the public health approach to eliminating disparities in health public health systems and services research: building the evidence base to improve public health practice united states innovations in healthcare delivery a call to action: lowering the cost of health care reduced mortality with hospital pay for performance in england practical challenges of systems thinking and modeling in public health public health: essentials of public health health united states the funding organization will want to know what will be the expected product of the program in measurable process (e.g., immunization coverage) or outcome indicators (e.g., reduced child mortality). projections will be based on the intended activities and known outcomes of other past programs with similar goals in the same or other countries (environmental scan), and should be supported by a review of local and international literature on the topic. the activities section of a proposal should include a timeline of the intended actions and a description of activities based on best practices. the expected outcomes, monitoring and evaluation, and justification are all part of the presentation (box . ). the following utility standards ensure that an evaluation will serve the information needs of intended users: l identify and engage stakeholders, including relevant government agencies, people or communities involved in or affected by the evaluation, so that their needs and concerns can be addressed. l develop and describe the program. l focus the evaluation design with ethical standards and review requirements respected.l gather credible evidence -the people conducting the evaluation should be trustworthy and competent in performing the evaluation for findings to achieve maximum credibility and acceptance. information collected should address pertinent questions regarding the program and be responsive to the needs and interests of clients and other specified stakeholders.l justify the conclusions -the perspectives, procedures, and rationale used to interpret the findings should be carefully described so that the bases for value judgments are clear. l ensure sharing and use of information and lessons learned -evaluation reports should clearly describe the program being evaluated, including its context and the purposes, procedures, and findings of the evaluation so that essential information is provided and easily understood. substantial interim findings and evaluation reports should be disseminated to intended users so that they can be used in a timely fashion to encourage follow-through by stakeholders, to increase the likelihood of the evaluation being used.l standards of a project should focus on scientific justification, utility, feasibility, propriety, and accuracy. l a program in this context includes: -direct service interventions -community mobilization efforts -research initiatives -surveillance systems -policy development activities -outbreak investigations -laboratory diagnostics -communication campaigns -infrastructure building projects -training and education services -administrative systems and others. title page -name of project; principal people and implementing organizations; contact person(s); timeframe; country (state, region); target group of project; estimated project cost; date of submission.l introduction -provides project background including the health issue(s) to be addressed, a situational analysis of the health problem, the at-risk and target populations, and existing programs in the community; includes an international and national literature review of the topic with references. budget -estimated cost of expenditures, including human resources, activities, running costs, and overheads for project and evaluation. l monitoring and evaluation -what evidence will be used to indicate how the program has performed? what plan is recommended for periodic follow-up of project activities (including timeline and measures) to implement lessons learned from positive or negative outcomes, and use of resources? how efficient and effective is the project? l conclusions -what conclusions regarding program performance may be drawn? what conclusions regarding program performance are justified by comparing the available evidence to the selected standards? l reporting -report the project to the key stakeholders and public bodies; publication in peer-reviewed journal if possible.l justification -why is this project important and timely, and how will implementation benefit health of the community?core competencies are essential knowledge, skills, and attitudes necessary for the practice of public health. they transcend the boundaries of specific disciplines and are independent of program and topic. they are the building blocks for effective public health practice, and the use of an overall public health approach.generic core competencies provide a baseline for what is required to fulfill public health system core functions. these include population health assessment, surveillance, disease and injury prevention, health promotion, and health protection.the core competencies are needed to effectively choose options, and to plan, implement, and evaluate policies and/ or programs in public health, including the management of incidents such as outbreaks and emergencies.a public health practitioner is able to: l describe selected policy and program options to address a specific public health issue l describe the implications of each option, especially as they apply to the determinants of health and recommend or decide on a course of action l develop a plan to implement a course of action taking into account relevant evidence, legislation, emergency planning procedures, regulations, and policies l implement a policy or program and/or take appropriate action to address a specific public health issue l demonstrate the ability to implement effective practice guidelines l evaluate an action, a policy, or a program l demonstrate an ability to set and follow priorities, to maximize outcomes based on available resources l demonstrate the ability to fulfill functional roles in response to a public health emergency. of the individual, the population, and the economy. because health care employs large numbers of skilled professionals and many unskilled people, it is often vital to the economic survival of small communities, as well as for a sense of community well-being.management includes planning, leading, controlling, organizing, motivating, and decision-making. it is the application of resources and personnel towards achieving targets. therefore, it involves the study of the use of resources, and the motivation and function of the people involved, including the producer or provider of service, and the customer, client, or patient. this cannot take place in a vacuum, but is based on the continuous monitoring of information and its communication to all parties involved. these functions are applicable at all levels of an estimated , french people lived with dementia; half were diagnosed and one-third were receiving treatment; percent of people with alzheimer's disease were living at home; percent of all nursing home residents lived with some form of dementia; a day's care cost € while full-time residency in a nursing home ranged between € and € . l identify the early symptoms of dementia and refer people to specialists. l create a network of "memory centers" to enable earlier diagnosis. "for millions of americans, the heartbreak of watching a loved one struggle with alzheimer's disease is a pain they know all too well. alzheimer's disease burdens an increasing number of our nation's elders and their families, and it is essential that we confront the challenge it poses to our public health. " on january , president barack obama signed into law the national alzheimer's project act (napa), requiring the secretary of the us department of health and human services (hhs) to establish the national alzheimer's project to: l create and maintain an integrated national plan to overcome alzheimer's disease (ad). l coordinate alzheimer's disease research and services across all federal agencies. l accelerate the development of treatments to prevent, halt, or reverse the course of ad. l improve early diagnosis and coordination of care and treatment of ad. l improve outcomes for ethnic and racial minority populations that are at higher risk for ad. l coordinate with international bodies to fight ad globally. the law also establishes the advisory council on alzheimer's research, care, and services and requires the secretary of hhs, in collaboration with the advisory council, to create and maintain a national plan to overcome ad. research funds are being allocated towards that end. education for health providers, strengthening of the workforce, for direct care and for public health guidelines for management of ad, education and support for caring families, addressing special housing needs for ad patients and many other initiatives are proposed in this comprehensive approach to a growing public health problem. enhancing public awareness is crucial to achieve the goals set out in this plan. key: cord- - gv yfh authors: cho, hae-wol title: enemy at the gate date: - - journal: osong public health res perspect doi: . /j.phrp. . . . sha: doc_id: cord_uid: gv yfh nan individuals at a higher risk of transmitting wfb communicable diseases as they may have come from areas where the population is living in a high-density, poor, social environment. in addition, medical care may be minimal, and access to safe drinking water and clean food may be limited. providing improved essential information on good personal hygiene practices to international travelers from/to korea maybe a simple and effective measure for minimizing the possibility of spreading wfb communicable diseases. world health organization. guidelines for drinking-water quality world health organization [internet]. foodborne diseases foodborne and waterborne diseases joint external evaluation of ihr cope capacities of the republic of korea mission report risk of water and food-borne communicable diseases in travelers entering korea key: cord- -dnuakd h authors: chan, hui yun title: hospitals’ liabilities in times of pandemic: recalibrating the legal obligation to provide personal protective equipment to healthcare workers date: - - journal: liverp law rev doi: . /s - - -z sha: doc_id: cord_uid: dnuakd h the covid- pandemic has precipitated the global race for essential personal protective equipment in delivering critical patient care. this has created a dearth of personal protective equipment availability in some countries, which posed particular harm to frontline healthcare workers’ health and safety, with undesirable consequences to public health. substantial discussions have been devoted to the imperative of providing adequate personal protective equipment to frontline healthcare workers. the specific legal obligations of hospitals towards healthcare workers in the pandemic context have so far escaped important scrutiny. this paper endeavours to examine this overlooked aspect in the light of legal actions brought by frontline healthcare workers against their employers arising from a shortage of personal protective equipment. by analysing the potential legal liabilities of hospitals, the paper sheds light on the interlinked attributes and factors in understanding hospitals’ obligations towards healthcare workers and how such duty can be justifiably recalibrated in times of pandemic. the onslaught of covid- has led to a worldwide race for personal protective equipment ("ppe") ranging from protective goggles, gloves, full face shields, fluid repellent gowns, aprons, surgical masks, and medical equipment such as ventilators and respiratory machines. the british medical association has repeatedly issued urgent pleas to the uk government for the timely supply of ppe for frontline healthcare staff in delivering patient care. frontline healthcare workers without ppe continue to face severe infection risks posed by ppe shortage constitutes a pressure point for healthcare systems, with strong correlations between its scarcity and high covid- infections and death among healthcare workers. covid- has claimed more than healthcare workers' lives, and infected more than , in the usa, while ppe shortage and substandard ppe in spain have resulted in more than , healthcare workers becoming infected. reports of heightened stress experienced by frontline staff are not new; either from the fear of being infected or in transmitting the infections to their families. the shortage has prompted drastic reactions from some governments in downgrading ppe protection standard inconsistent with who advice, inevitably raising questions about harm to healthcare workers. this measure in turn produced several adverse effects on care provision. it has created an exodus of critical healthcare staff due to their inability to continue working. clinical decisions were made to either delay care or minimise the risks of harm (while still working in high risk environments), underscoring rationing in action, and making difficult situations more taxing. although they are not compelled to continue treating patients, the inability to do so generated moral guilt as they see their colleagues on the frontline operating in hazardous conditions. recent developments have witnessed strong responses from the public and healthcare workers, ranging from pursuing legal actions against the government or their employers (hospitals) for breaching their obligations of care towards employees to calling for a full public inquiry into pandemic management, including the status of the ppe stockpile. specific claims by healthcare workers include the legality of guidance on reusing ppe and permitting patients to be treated without ppe in contravention of their right to protection of health and safety at work. this development is not only confined to the uk, as doctors in spain have launched legal actions against the health authorities for breach of duty in ppe procurement failure. considerable coverage continued to be given to issues concerning allocation of scarce resources, the clinical and moral dilemma to treat, and the urgent need to have protective gears for frontline staff. the pressing legal considerations regarding employer's failures in procuring sufficient resources for pandemic purposes remain under-explored. this paper examines how the pandemic affects the obligations of hospitals as employers towards their frontline healthcare staff in fulfilling their responsibilities during pandemic, and the impetus on re-evaluating existing and future legal obligations. it considers the extent to which hospitals have breached their obligations in failing to take appropriate measures to safeguard the health and safety of their employees and to prevent them from being exposed to avoidable risks. while convincing justifications are available regarding the difficult roles of hospitals during pandemic, significantly persuasive arguments can be made for hospitals' liability in breaching their duty to ensure the safety of healthcare workers. these claims will be considered in determining the extent to which such liability can be recalibrated in times of pandemic. while the analyses are drawn from the uk context, the substantive importance is equally relevant as the battle for critical medical supplies is felt across the world. an employer's duty is personal and non-delegable. the employer's duty is one of reasonable care and skill, to provide a safe place and system of work, with adequate plant and equipment, including competent employees and resources, according to the industry and environment in which they operate. such obligations extend to maintaining the equipment and ensuring that they are of sufficient quantity, necessitating regular inspections and monitoring. providing a safe system of work signals a gamut of considerations; ranging from ensuring proper working systems, arrangements and instructions, identifying the purpose of the work, specific tasks and scope to assess risks and install precautionary measures for the employees' health and safety. a system of work thus encompasses an assessment of the adequacy for the "whole course of the job or it may have to be modified or improved to meet circumstances which arise." the consequence of this duty is that the system ought to be reasonably safe, and not perfectly safe, through assessing the inevitable dangers associated with the work, guided by industry norms. these norms often evolve through time and employers must be aware of such developments in updating their emanuel et al. ( ) , ranney et al. ( ) . wilsons & clyde coal company v english [ ] ac , lunney et al. ( , p safety standards to reflect current knowledge based on best scientific evidence. consequently, though it can be suggested that the science of covid- is still developing, the lack of knowledge regarding its effect may not automatically preclude employers from being liable. doctors, surgeons and nurses employed in the service of hospitals are treated as employees under the law and hence they are owed a duty of care. the common law duty of care identified above thus obliges hospitals to provide competent staff, adequate material and a safe, proper system and effective supervision. the extent to which employers ought to provide for ppe invites considerations such as the risk, likelihood, magnitude and consequences of the injury, and the availability and costs of providing such protective equipment. in hospitals, the provision of adequate plant and equipment signifies ppe such as gloves, masks, full length gowns, shields and goggles. hospital working zones have become "contagion hubs" with streams of patients (symptomatic and asymptomatic) receiving care and treatment from healthcare workers. it is reasonably anticipated that healthcare workers are continuously exposed to significant infection risks from treating these patients. the provision of ppe is directly relevant to the work for which healthcare workers are employed to do, and which are normally and reasonably expected to be provided with, consistent with who guidelines for treatment of infectious diseases. the omission to provide ppe to frontline staff unavoidably attracts questions of hospitals' negligence. in determining whether the employers are negligent in failing to remedy the lack of ppe, reference is made to a number of important factors under the common law and statutory instruments. factors that illuminate the liability of the parties, such as the nature of the work, its inherent risks, the (im)possibility of establishing precautionary measures in preventing or reducing the likelihood of risks materialising, the extent to which such measures commensurate with the means and ends, are examined. risk assessments, particularly whether the risks are amplified by the failure to provide in an otherwise acceptable risk in employment, common practices, and resources similarly influence the determination of duty. statutory duties under the health and safety act, regulations on ppe , the relevant guidance issued by the department of health and social care and public health england to healthcare workers are relevant considerations. risk assessment is an important feature in determining the likelihood of injury and whether a breach has occurred in a system of work. it sets the level of reasonableness of precautionary measures against the health and safety risks employees may encounter in the course of their employment. the firemen assuming risks associated with not having a jack fitted in the truck, thus precluding their employers from liability. it has been questioned whether this approach has unjustly discriminated claimants from emergency services that continue to assume risks for the greater good but is otherwise uncompensated for the injuries sustained. there is considerable force in this reasoning that applies to frontline healthcare workers. they face prolonged risks on a daily basis, which includes periods of emergency and hours with clinical rotations between high and low infection risks zones in hospitals. their purpose is to save lives, but without ppe they are putting the lives of patients at risk. the likelihood of injury is real and the gravity of the consequences is magnified. while there are risks inherent in patient treatment, infectious diseases attract extra hazardous elements into the work. the seriousness of harm caused to healthcare workers is not considered small. infected healthcare workers would be off sick, unable to treat, and face the possibility of death. the risks of infection are higher without ppe compared to those with basic ppe. standard public health practices require healthcare workers to don appropriate ppe. this in turn invites questions on cost and practicability in addressing the risks that persist in daily clinical encounters. although frontline healthcare work is not intrinsically dangerous compared to crane workers in the building industry, the cumulative risks arising from covid- , and other preventable factors could potentially render such employment dangerous. healthcare workers combating infectious diseases accept the associated risks that are intrinsic to the work; that does not mean that they have voluntarily assumed all those risks which could be prevented or reduced with the exercise of reasonable care by the hospitals. the example of healthcare staff at weston hospital in england who tested positive after contact with infected patients only goes to demonstrate the severity of the situation. if we accept that covid- is hazardous, then it justifies the protection from the risks of infection through ppe provision. ppe constitutes the first line of protection against infections, as they need to be in close proximity to patients. ppe thus can reduce the chances of infection and in some cases prevent further infections among healthcare workers. such risks clearly outweighed the cost of providing ppe, and the omission to provide is obvious. while the likelihood of the majority of the healthcare workers to succumb to the virus is small owing to the age and health demography, the consequences of such infection materialising are grave if they were infected. courts usually take into account established practices in assessing whether the defendants have breached their standard of care given the circumstances prevailing at the time. it can be reasonably said that ppe is a common practice; logical and of common sense in treatment of infectious diseases. hospitals should act in accordance with such approved, common practice of ensuring adequate ppe supply. the most practical preventive measure, which is providing ppe is not onerous, compared to the risks of injury to healthcare workers. while cases have shown that employers have not breached their duty in failing to provide protective screens or suitable emergency vehicles for the employees at wartime, ultimately, balancing these risks against the measures to remove the risk requires a consideration of the end to be achieved. the end to be achieved in the pandemic context is the dual outcomes of protecting public health and maintaining the health and safety of healthcare workers in the course of their employment. statutory instruments have given the duty of care a stronger emphasis. the personal protective equipment at work regulations ("ppe regulations") under the health and safety at work act clearly set out the types of legal responsibilities that employers should follow. ppe under the regulations means "all equip-ment…intended to be worn or held by a person at work and which protects the person against one or more risks to that person's health or safety, and any addition or accessory designed to meet that objective." consequently, ppe in the hospital context is broad enough to include all equipment that protect healthcare workers from infectious particles arising from aerosol generating procedures, ventilators, respirators or testing facilities with high concentrations of droplets or airborne diseases. regulation ( ) provides the litmus test for the suitability of such ppe. ppe are considered "suitable" relative to the risks involved for the purpose of carrying out the work, the conditions and duration of exposure, the state of health of the wearer, the workstation's characteristics, and practicable in controlling the risks. ppe has to be hygienic and for the sole use of the wearer, thus the guidance to reuse them may raise questions, unless they are addressed by having adequate measures that ensure the hygiene is not compromised where reuse is needed. such ppe should also be maintained and replaced. the exposure to covid- infections is directly workrelated, and employers have the means to protect and implement control measures to reduce the chances of risks materialising. these circumstances directly oblige hospitals to ensure that ppe stockpiles are sufficient so that they are readily at hand when they are needed by the healthcare workers. the difficulty arises when there is a disparity between the actual supply and provision of ppe, and meeting compliance with the legal requirements. recent public health england (phe) guidance has emerged in response to the pandemic in advising hospitals on establishing a safe system of work through yorkshire traction company limited v walter searby [ ] ewca civ ; in daborn v bath tramways ltd [ ] all e.r. , at , the driver of ambulance with left-hand drive was found not negligent when, in wartime, she turned to the right without giving a signal. watt v hertfordshire [ ] all e.r. . regulation ( )(a). for example the phe guidance noted that some ppe may be reused, subject to effective cleaning system. regulations and . phe is tasked with national oversight and leadership on public health issues, and in this capacity support nhs, manage national public health service and support the public health workforce development, see also herring ( , p ). organisational means, ranging from suitable work processes, engineering controls, environment, and provision and use of both work equipment and ppe (single sessional use of particular ppe, reusable ppe) and decontamination procedures. the guidance recognised the employers' legal obligation to protect workers from health and safety risks in controlling and limiting infection transmissions, including assessing risks associated with patient influx, and reduced staff numbers due to illness. this aspect corresponds with regulation in assessing the risks of injury and the purpose and adequacy of such gears where available. however, developing phe guidance, in addressing ppe shortage highlighted "the compromise needed to optimise the supply of ppe in times of extreme shortage… protect stock levels from unnecessary use and support staff to use the right equipment." such modifications mean that ppe are used throughout the session unchanged between patients, "as long as it is safe to do so", which differ from the who guidance. other modifications, such as lower grade face masks reflect a standard which is lower than the who recommendation. while reusing gloves should be avoided, some ppe such as face masks, gowns and eye protection are only liable to be changed when they are visibly contaminated or damaged. the implication is that such ppe would have lost the protective function, putting the healthcare workers at risk under the guise of protection. the direct correlation between staff engagement and patient experience demonstrates the close association between the quality of care patients received and the provision of treatment by healthcare workers. the nhs, a government-funded healthcare service under which hospitals in the uk operate sets the standards for service provision and professionalism. in essence, it commits to provide high quality, safe and effective care, and recognises that a valued and supported workforce will translate to quality patient care. the nhs constitution, which outlines the basic principles and values of the nhs governing the relationships between healthcare workers, patients and the public generally, illuminates particular rights under employment laws, and nhs pledges to their staff, with the overarching priority of delivering patient centred care. patients have the right to be treated professionally by qualified healthcare workers as part of a safe system of work in a clean and secure public health england, department of health and social care and nhs england ( ). guidance: handbook to the nhs constitution for england ( ). nhs, the nhs constitution for england ( ). several guidance were published advising hospitals of rapid changes to ppe use and disposal: guidance: introduction and organisational preparedness may https ://www.gov.uk/gover nment /publi catio ns/wuhan -novel -coron aviru s-infec tion-preve ntion -and-contr ol/intro ducti on-and-organ isati onal-prepa redne ss; guidance: covid- personal protective equipment (ppe) may https ://www.gov.uk/ gover nment /publi catio ns/wuhan -novel -coron aviru s-infec tion-preve ntion -and-contr ol/covid - -perso nalprote ctive -equip ment-ppe produced jointly by department of health and social care (dhsc), public health wales (phw), public health agency (pha) northern ireland, health protection scotland (hps), public health england and nhs england. environment, signalling the necessity of an appropriately equipped and maintained environment. the cyclical nature of patient care and duty to staff is clearly reflected, with explicit recognition that staff should be provided with the resources and support to deliver quality patient care and for healthcare workers to identify and eliminate risks to patients. the failure to provide ppe for healthcare workers has significant relevance and broader implications to patient care. healthcare workers with substandard or without ppe are exposed to infection risks, rendering them susceptible to absence from work for at least days, resulting in workforce depletion. this is especially critical for healthcare workers functioning in high risk zones. healthcare workers operating in other units would be asked to support the continuity of care for covid- patients, thus creating a void in patient care in less critical areas. frontline healthcare workers face immense pressure treating patients under crisis. while there is an expected level of stress that corresponds with the nature of the work in providing care, transferring workers from other specialty units to assist their frontline colleagues may prove exacting, given that their training and competency for the job can vary. the rerouted human resources meant that patients in other units are inadvertently neglected due to reduced staff. another serious, adverse outcome is the risks of transmitting the infection to patients where healthcare workers are unaware that they have been infected; particularly in asymptomatic situations. ppe greatly reduce the risks of infection in the first place, for both the health and safety of the healthcare workers and patients. the strong correlation between the augmented risks of infection and ppe shortage creates a system where patients are harmed. the commitment to deliver quality patient care and a good working environment has, unfortunately, become questionable in this environment. while the nhs constitution provides for avenues of complaints to line managers, the bureaucracy meant that staff will continue to face infection risks unless they refuse to treat patients. prior insights from previous pandemic and the lack of remedial measures to address the weaknesses identified in the healthcare system during national pandemic simulation exercises may raise valid concerns regarding errors of judgement that resulted in the inability to provide ppe in a timely manner. public authorities hold and exercise discretionary powers within the constraints of complex decisions, social utility and organisational objectives. however, are we setting a standard too high for the nhs managers in procuring ppe, given the prevailing circumstances? are there any exceptions to this duty in times of pandemic, where it can be reasonably anticipated that healthcare systems may become inundated, resulting in the necessity of working within a less than optimal environment? the following sections consider arguments see walker v northumberland cc [ ] all er . bowcott ( ) . and counterarguments limiting hospitals' legal obligations towards healthcare workers. the characteristics of covid- are essential in understanding the severity of the pandemic, its impact on the healthcare systems, and why particular focus on the legal obligations of hospitals towards healthcare staff becomes significant now and in the future. the morphology of covid- has garnered international attention, with scientists investigating its biochemical components for preventive, containment and vaccine trials purposes. it was first reported in wuhan, hubei province of china on december , with origins traced to the s as common viruses that infect humans, particularly in respiratory functions. the transmission methods and survival on various surfaces have been the subject of intense scrutiny with findings that the virus can be detected on surgical masks for up to seven days. hospital working areas such as intensive care units, self-isolation wards, doorknobs and keyboards are found to carry high concentration of viruses. viruses were present in the body for more than a week prior to visible symptoms with the highest virus load found in the early stages of infection, suggesting that asymptomatic individuals could be more infectious than symptomatic ones as sources of population transmissions. these findings are crucially linked to the recommendations for use, reuse and disposal of ppe and its effect on healthcare workers who were infected. around % of infections in england recorded between april and june were found in health and social care workers resulting from their direct interactions with patients in hospitals. spain, italy, china and the usa have reported between % and % of infection cases from healthcare workers while treating infectious patients. this underscored the detrimental effects of ppe shortage on healthcare workers. the lack of ppe has cast the spotlight on augmented risks to healthcare workers. such risks of harm are widely acknowledged. healthcare workers experienced psychological and moral distress, frustrations and anxiety in carrying out treatment decisions, fear of risking their health, and infecting their families and patients. they are similarly exposed to emotional harms from being prevented to voice their concerns on health and safety, or compelled to provide care under unsafe circumstances. the british medical association has repeatedly supported the position that healthcare workers should not continue working with substandard ppe or without basic ppe that could prevent them from avoidable harm. however, this has not allayed the harmful consequences to healthcare workers. ibid. wilson et al. ( ) . who ( ). british medical association ( ), carrington ( ), smyth ( ) . british medical association (n , p ). european centre for disease prevention and control ( ). the force of the covid- exigency poses an arguably persuasive factor in limiting employers' liability. while covid- is frequently hailed as unprecedented, the nature of influenza pandemic is not completely unknown. history has revealed examples of pandemic that occurred across centuries with various degrees of severity. once the who declared covid- as a pandemic, ppe became global focal points. countries rushed to secure additional ppe, with demands far exceeding supply within an asymmetrical circulation of medical resources. although the challenge of scarce resources is a common predicament affecting hospitals, simulation exercises (e.g.: public health england ) undertaken in some developed countries provide ample opportunities for advance preparatory measures. the experiences of frontline healthcare workers from other countries several months before the pandemic reached the uk would have constituted sufficient notice of the gravity of the situation. hospitals have grown in complexity through centuries. the extent to which institutional structures, devolved administrations and resourcing constraints provide justifications for their omission needs to be determined within their role as public authorities. the nhs structure is represented by a complex matrix of quasi-government, private entity with specific powers and responsibilities, thus affecting their liability to healthcare workers as employees, moving beyond the simplicity of hospitaldoctor employment relationship. it has been said that "to describe the structure of the nhs is not an easy task…partly because it is a labyrinthine and partly because the nhs has been and still is undergoing enormous structural changes with bodies being created, merged and destroyed at an astonishing rate." the nhs is funded from taxes, with allocations approved by parliament, and expenditures controlled by clinical commissioning groups. nhs managers work in a complex environment, from purely administrative to larger roles of system management and leadership with accountability to frontline healthcare workers, the department of health, private providers, and subject to public scrutiny. nhs managers are expected to balance several competing rights, among others the public health, healthcare workers' rights and organisational constraints. the creation of internal market supported by the health and social care act has been critiqued as one of the structural problems permeating nhs which produced a considerably weakened responsive capability during pandemics. continuous public sector changes, marketisation strategies walsh ( ) . and funding cuts have led to the government's reliance on private firms to provide services during public health emergencies. suggestions that phe decisions were politically influenced have led to allegations that ppe guidelines were not necessarily led by public health science, as seen in the case of lowering ppe standards due to shortage, contrary to who recommendations. hospitals performed their functions within the wider framework of organisational complexities, decision-making hierarchies and limitations, and political willpower. they often have statutory responsibilities involving difficult and sensitive judgements to make. they also inadvertently suffer from particular authority or financial barriers, which puts them in unenviable positions when faced with claims of negligence in equipping employees with ppe. the discretionary powers available for public authorities, other remedial options and consequences for public service delivery influence how standards are determined. a finding of liability may result in obstructions with the exercise of discretionary powers guided by particular reasoning within the system for purposes of efficient and necessary governmental machinery. the structural determinants illuminate the systemic failures that plagued these entities. as christian witting accurately observed : "in some cases, decisions made at a high political level inevitably entail difficulty in meeting service targets or in under-servicing, and must be expected to result in failures in care. the failures in care that result are systemic in nature. their acceptability is politically pre-determined and courts might have little authority to redress them." resource availability within public authorities remains a pressure point among competing sets of considerations. it indicates the dilemma of meeting social needs for the effective functioning of society within a finite environment of resources. public authorities traverse the boundaries of public and private law in judicial applications of the law of negligence, human rights and statutory powers. this is reflected in the nhs context, which represents one of the most politically charged and publicly contentious issues of all times. daborn demonstrated that in cases of national emergency, the lack of available transportation resources, the inherent limitations of the ambulance and the need for continuity in emergency services precluded the defendant from further duties. while not a complete defence, public service liability is closely connected to resource constraints, weighing against the finding of liability. cases have shown that although public body should not be treated any differently from commercial employers, financial constraints and rigidity in decision-making are relevant factors. this signifies the balance between resource availability and cost and practicability of preventing workplace injury. the issue of how far the duty should go when it comes to omissions to provide ppe in a pandemic context is unresolved. given the public health crisis precipitated by the pandemic, it is likely that hospitals would be 'forgiven' for their failure in fulfilling their legal obligations on the basis of emergency and their constraints as public authorities. however, hospitals are the linchpin in delivering frontline healthcare services and maintaining public health in an infectious disease setting. it is argued that hospitals should depart from an approach that expose healthcare workers to infection risks, harm public health and is inconsistent with the core nhs patient centred care principle. the provision of ppe is fundamental to healthcare workers in carrying out their work. ppe protect healthcare workers, and in turn enable them to deliver crucial care especially in times of pandemic. it is not an infallible method, but without these ppe they are most likely to suffer from injury and harm from the risks of infection. the failure to provide ppe to healthcare workers is a failure to deliver care to patients at critical points. the size, capacity and resources available to hospitals are influential considerations; nevertheless, they are not determinative to the extent of justifying the omission to provide ppe. a comparison can be drawn to ppe provision during normal times and in times of emergency. in normal times, the impact, while it may be felt, may not be acute for patient delivery care because the limit has not been breached. however, in emergency times, the impact of the failure to provide ppe to healthcare workers is severe. the daborn and watt v hertfordshire cases had established the importance of the end to be achieved in saving lives, consequently such emphasis can be inferred as recalibrating the obligations of essential services and balancing the rigidity and prescribed exclusion of liability. when the objectives are to save lives and ensure the continuity of vital healthcare delivery, it would appear contradictory to omit the provision of ppe that directly enable the treatment and care of patients. the lives of frontline healthcare workers and patients justified the provision of ppe. these arguments deviate from the standard argument of resource constraints, but they offer a strong reasoning why they should not be precluded. imposing the duty to provide ppe is therefore central in ensuring healthcare workers are protected from the risks of infection and to realise the aim of delivering patient-centred care to the public. thus, this duty should be adjusted to the extent of meeting the requirement of basic provision of ppe and ensure the continuity of such ppe supply in spite of the pandemic. this argument may seem contentious because there are persuasive cases that will preclude the finding of liability in a situation where resources are scarce and that individuals are expected to endure the crisis. however, hospitals need to demonstrate that they have proper mechanisms in place to address shortages in prolonged crisis instead of relying on arguments of budgetary limitations and hierarchy in decision-making. these points need to be identified at each step along the way to determine if the standard of care has been reasonably met. while cases involving public authorities often lend weight to the exclusion of liabilities; they can be distinguished from the current situation in several ways. first, the shortage in question is remedied by the availability of vehicles for the continuity of services, despite not the usual vehicle (e.g.: left-hand drive in daborn). the covid- situation represents a context where healthcare workers have exhausted these basic supplies and faced the consequences of no ppe for the remaining clinical encounters. second, covid- is not a singular incident but an event that is urgent in nature and continues on a daily basis. the severity of the harm meant that without any protection they face a high likelihood of being infected. the lowered standards of ppe use and recommendation for reusing ppe are attempts at remedying the complete shortage. the argument is that some protection is better than no protection. although hospitals are attempting to meet their obligations; ppe which are visibly damaged would cause harm under the guise of protection. the persistent lack of funding to hospitals has contributed to an environment where ppe shortage is tolerated and accepted as standard (though not reasonable) practice. ppe guidelines that decrease the health and safety standard exemplifies resource consideration. it is difficult to comprehend, even at the basic level, for employers not to provide essential ppe for protection against known risks within standard public health measures. covid- is an infectious disease, and the reasonable response is to provide ppe that eliminate or reduce the risks from exposure to such infections. while the purpose of the work is such that infections are incidental to the nature of the employment, ppe is an indispensable and cost-effective measure in minimising such risks. in spite of the difficulty in functioning within a resourcelimited environment, ppe is not purely best practice, but fundamental medical practice. an implication flowing from these considerations is recalibrating the mutual obligations between hospitals and their employees, underpinned by effective healthcare delivery consistent with the nhs constitution. a blanket approach to the finding of liability may be unsuitable, as not all hospitals are similarly equipped, though it remains incumbent on hospitals to fulfil their basic obligations without jeopardising the safety of healthcare workers. parallels can be drawn to the established standards and practices relating to ppe for employees working with hazardous materials. ppe can be modified but only to the extent where they are capable of providing full protection to healthcare workers, and not lower than the recommended standards. ppe availability inculcates a sense of assurance that frontline healthcare workers are valued and appreciated, both by the public and their employers, and for the workers, the confidence in carrying out their roles in treating and caring for infectious patients. system deficiency may be influential in determinations of liability, but it does not always prevail over what is reasonably expected from hospitals. hospitals have the moral duty to take care where their actions will affect those who might be affected by the failure to provide adequate and safe ppe: staff and patients. such duty falls within the remit of nhs managers. as covid- progresses, hospitals ought to have foreseen the impact of ppe on healthcare workers and patients; given the length of the pandemic, rather than a singular emergency. not all finding of liability will automatically result in floodgates, trivial claims or become burdensome for public authorities. rather, it reflects the social and public expectations of what is fair and reasonable. the legal claims filed by healthcare workers for ppe shortage reflect societal expectations of what ought to be done in ensuring healthcare workers are provided with sufficient ppe. departing from this standard would have stretched the limits of acceptable assumption of risks. the public, while accepting that covid- is an unprecedented health threat to the population, will not be kind in their assessment of the measures to contain the pandemic, particularly in response to the dearth of vital medical resources in times of crisis. it becomes imperative to recognise their vulnerabilities and to keep healthcare workers safe. systemic failures may well be compelling, but it is unsatisfactory to then say, there is nothing hospitals could do. reports have continuously demonstrated the correlation between the lack of ppe and higher risks of infection for healthcare workers compared to the public. this naturally translates to poor patient care as they become sick. there is clear neglect in ensuring stockpiles of ppe in meeting the basic requirement of ensuring workers' health and safety. the lack of clear direction and protocols in management and leadership has contributed to the failure of establishing a safe system of work. what would a reasonable healthcare provider do? it is to provide adequate ppe when it is needed and to have processes in place to supplement the stockpile. the saving of lives is a continuous emergency, reflected by the number and severity of patients healthcare workers treat daily. the discretionary power should be exercised towards ensuring resources are allocated towards meeting the obligations of hospitals during pandemic, in preparing sufficient ppe for healthcare workers. for example, the procurement team of the nhs trust is responsible for purchasing supplies and equipment for the hospital, where specific purchasing rules and budgetary limits apply. this translates to broader governmental responsibilities within the decision-making authority which subsequently influenced the overall level of pandemic preparedness. the long-term deficiency in preparedness for a potential infectious diseases outbreak, and the failure to remedy ppe availability through systematic and appropriate procurement arrangements for continuous supply have contributed towards hospitals' inability to replenish severely dwindled ppe stocks in a timely manner. these cumulative factors have resulted in the breaching of ppe limits to the detriment of healthcare workers. the hesitance towards advance preparedness is remarkable, given the window period available to the uk with precedents from china and neighbouring european countries. hospitals, especially the well-resourced ones, with the hindsight of previous experiences in treating patients under the deluge of pandemic could have phelps v london borough of hillingdon [ ] a.c. . parshley ( ) . hunter ( ), mahase ( a, b, c, d). foreseen the need to install precautionary measures to safeguard the continuity of essential supplies and safe functioning of workplace for healthcare workers. adopting such preparatory measures would have enabled a safer response strategy for critical patient care in anticipation of increased burden on the frontline staff, adjusted according to the size and scope of the hospitals' operations and resources. the next section offers practical recommendations in pre-empting ppe shortage. the failure of hospitals in providing healthcare workers with ppe has resulted in concerted and self-help measures in procuring ppe. the most common preparation is stockpiling essential ppe. this comes as a benefit of hindsight; nonetheless valuable in preparation for second or third waves of infections, and as crucial planning for future pandemics. for example, prior to the onset of infected cases in new york, some hospitals have acquired millions worth of ppe as early as february on the basis that "you can never have enough." this foresight paid off, enabling healthcare workers to continue working while protected. an appreciation for improved procurement procedures in place, such as the role of supply chains in ppe procurement is integral in successful pandemic preparation. the public-private procurement chain has ensured that new zealand has sufficient ppe for the healthcare workers and the population, with additional weekly supplies from local manufacturers. the shortage in the uk remains acute. reports have emerged that care home workers were requested to continue caring for infectious patients without ppe in the event of extreme shortage. local councils are responsible for delivering healthcare services (e.g.: care homes and community mental health services) which falls outside the nhs supply chain scope. this means that they are most likely to lack ppe in times of national emergency. jurisdictional divisions have, unfortunately hampered the effective cooperation for public health to the detriment of frontline healthcare workers and the public. the systemic impediments in the nhs organisational structures might be difficult to overcome immediately, but the awareness of how ppe delivery is hampered by these institutional barriers can pave the way for alternative routes to remedy the situation. supply chain management and logistical issues are beyond the remit of employees personally, and those in charge of organisational operations should be responsible in fulfilling the obligations in ensuring that ppe are in stock and at hand when they are needed. this means having additional supplies for emergency purposes ornstein ( ) . covid coronavirus: tonnes of ppe now in auckland warehouse apr, https ://www.nzher ald. co.nz/nz/news/artic le.cfm?c_id= &objec tid= . taylor ( ) . see further laurie and hunter ( ). while procurement for additional ppe is in progress to ensure continuity in supply for healthcare workers. consequently, measures include revisiting internal procedures in assessing the individual levels of preparedness in hospitals, and preparing alternative plans in redirecting patients to hospitals with more capability to deal with infectious patients if the scale and capacity of the local hospitals do not permit the proper treatment and availability of care to the patients without risking staff safety. it is equally valuable to treat the pandemic as akin to disaster response with mass casualties as it enables the operation of protocols and processes for such emergencies occurring for a substantial period of time. nhs managers must be aware of such developments, encompassing clinical and administrative appreciations of the effect global supply chain has on essential ppe procurement in planning and reducing the gap between stock depletion and arrivals. this entails building good, working relationships with relevant suppliers and producers. as resources are finite, having operational plans in advance at the institutional level would alleviate the burden of dealing with these issues during emergency when there are absolutely no ppe available. infrastructural planning, reorganisation and improvisation are essential to remedy the weaknesses that prevented hospitals from fulfilling their obligation in providing a safe system of work and adequate plant and equipment for the purpose of caring for patients. it is not advocated that there should be a perfect system but a functioning system at a fundamental level that ensures that employees' health and safety are not compromised in times of pandemic, and that risks are controlled within reasonable limits. longer term measures include instituting improved communication among hospitals within proximate areas in breaking the disease transmission chains locally and regionally. this approach will facilitate local capabilities in minimising the disease spread, especially in under-resourced and rural areas healthcare services. such regional networking approach has resulted in successful pandemic response among hospitals in lombardy, italy in coping with patient surge. the current decentralised decision-making approach in the nhs and the lack of effective communication policies in disaster management have led to critical resourcing issues. processes and procedures that allow a centralised, consistent response mechanism in national emergency are essential in ameliorating some of the difficulties in pandemic response and management. for example, an emergency "clearinghouse" that acts as a centre is helpful to identify areas with high needs for ppe so that immediate actions can be taken to distribute ppe to these critical areas. increasing local production capacity and supply in times of crisis are central in ensuring uninterrupted supply from local sources and less reliance on external producers during ppe scarcity. spain, for example has aimed to produce millions of masks and other essential ppe on a monthly basis to meet the needs of healthcare workers. when the shortage was first reported, the local and national level cavallo et al. ( ) . hunter (n ). livingston et al. ( ) . sappal ( ). communities in the uk were very supportive towards the healthcare workers in creating homemade ppe and supplying them to healthcare workers. although this is admirable, these supplies may not meet the adequate level of protection to ensure that infection risks are minimised. one way of overcoming the obstacle is to create a streamlined effort between local governments, charitable organisations and local volunteer groups to ensure they meet the safety requirements. this approach would help local and independent manufacturers to achieve local production capacity for the benefit of the communities within a shorter amount of time, and less dependent on outsourced procurement agencies or importation. it is also a stop-gap measure while awaiting incoming ppe supplies from centralised distribution centres. this move is advantageous to the local communities, as local hospitals can continue to treat patients without being forced to turn them away due to ppe shortage. reusing ppe is an option to ease the pressures of ppe shortage. however, the direction to reuse ppe can only be safely implemented where there are protocols for cleaning, disinfecting and storing reusable ppe and limited to ppe that are capable of being reused safely. such essential protocols must include appropriate laundry capacity, whether in hospitals or outsourced to commercial entities. other options include repurposing suitable equipment into ppe that are safe to use for eye and face shields, such as gas masks or sports eye protectors. employees should not be put in an already vulnerable position without the minimum support and infrastructure to carry out their work. the pressing problem of insufficient ppe represents the tip of the iceberg. it reveals a fragile structure in the healthcare system, with the implications of covid- felt long after it has come and gone. the level of provision of care for the population in times of pandemic is closely connected to the health workers' risks and safety. the analyses bring to light the importance of implementing sustainable measures for population health. more innovative ideas are needed for producing and replenishing important resources to pre-empt the domino effect arising from a lack of resources in times of pandemic. hospitals are obliged to be more forthcoming in providing clarity with regards to the supply of resources, and to accommodate the possible reluctance of healthcare workers in working in unsafe circumstances. frontline workers who are being prevented from airing their concerns on the severe lack of adequate ppe is detrimental to their functions in providing care. it could not be said to have met the aims of patient safety when staff are not equipped, valued, empowered or supported in carrying out their work. this paper has highlighted how the pandemic has affected the legal obligations of hospitals to healthcare workers in the provision of ppe. hospitals as employers have obligations towards healthcare workers, which include providing a safe livingston, desai, and berkwits (n ). ibid; cavallo, donoho and forman (n ). working environment and adequate equipment. the nature and extent of their duty are affected by their role as public authorities and in times of emergency. hospitals usually do not incur liability on the basis that they have service provisions that are influenced by resource constraints, limits in decision-making authority and bureaucracy. daborn and watt v hertfordshire exemplify the types of constraints public authorities face in providing social services, which weighed against the finding of liability. there are persuasive arguments from both perspectives in determining the extent of liability hospitals may incur in their failure to provide ppe in a timely manner. yet legal actions against governments and hospitals have opened up the possibility to reconsider the scope of liability, and the fulfilment of the expected standard under pandemic circumstances. the analyses show nhs managers would be in breach of duty for provision of ppe on the basis that the purpose of their activity is relevant in determining if an employer has breached a duty of care to an employee. while the negligence may be arguably excused during crises, the failure to meet the basic resourcing needs of frontline healthcare workers has breached the minimum standard and ethical imperatives in protecting them from life-threatening harm while they continue to treat an increased influx of patients. additionally, it has highlighted broader issues that plagued ppe procurement readiness preceding the pandemic. the analyses have indicated the extent to which the meeting of legal obligations in a pandemic can be undermined by external, underlying pressures arising from austerity policies introduced throughout the years, and an increasingly privatisation-oriented procurement practice, consequently weakening the public sector capacity in competently meeting public health threats. it is hard to dismiss the consistent pleas from frontline healthcare workers. such pleas strengthened the recognition of obligations to provide ppe. maintaining public health and safety in times of pandemic is of utmost importance; however the public can only be properly cared for where healthcare workers are able to continue working in a relatively safe environment in the midst of a pandemic. the fundamental need for ppe and the health and safety of healthcare workers must be prioritised. while this paper has gestured towards the obligations in providing ppe, the analyses have shed light on the inextricable implications of sound governance in meeting health priorities during a pandemic. it has canvassed a broader profile of underlying issues and proposed recommendations, emphasising the need for cohesive measures to address ppe shortage and alleviate the risks to frontline healthcare workers. the state may not be able to salvage the deaths and distress caused to frontline healthcare workers, but it can act more substantively to protect them and to restore public trust that the healthcare system would not collapse in times of pandemic. it has been argued here that hospitals ought to maintain their obligations to provide ppe to healthcare workers, because a failure to adequately protect them is also a failure to protect public health. supporting the health care workforce during the covid- global epidemic lacking beds, masks and doctors, europe's health services struggle to cope with the coronavirus apr bma. . covid- : ppe for doctors doctor couple challenge uk government on ppe risks to bame staff covid- -ethical issues. a guidance note uk strategy to address pandemic threat 'not properly implemented. the guardian hospital capacity and operations in the coronavirus disease (covid- ) pandemic-planning for the nth patient bereaved relatives call for immediate inquiry into covid- crisis doctors step up plea for adequate protection against coronavirus covid coronavirus. . tonnes of ppe now in auckland warehouse cecilia faulty batch of face masks prompts the isolation of more than a thousand spanish healthcare staff doctors to file legal challenge to ppe guidance fair allocation of scarce medical resources in the time of covid- european centre for disease prevention and control: an agency of the european union guidance: considerations for acute personal protective equipment (ppe) shortages s-infec tion-preve ntion -and-contr ol/covid - -perso nalprote ctive -equip ment-ppe. department of health and social care (dhsc) guidance: handbook to the nhs constitution for england bma demands urgent ppe solution after italian doctors die from covid- oxford: oup. high proportion of healthcare workers with covid- in italy is a stark warning to the world: protecting nurses and their colleagues must be the number one priority covid- and the stiff upper lip-the pandemic response in the united kingdom covid- : doctors still at "considerable risk" from lack of ppe, bma warns mapping, assessing and improving legal preparedness for pandemic flu in the united kingdom how a decade of privatisation and cuts exposed england to coronavirus sourcing personal protective equipment during the covid- pandemic text and materials, th ed global stocks of protective gear are depleted, with demand at " times" normal level, who warns covid- : % of cases will hit nhs over nine week period, chief medical officer warns covid- : hoarding and misuse of protective gear is jeopardising the response, who warns novel coronavirus: australian gps raise concerns about shortage of face masks protecting health care workers against covid- -and being prepared for future pandemics covid- : doctors' leaders warn that staff could quit and may die over lack of protective equipment nhs. . the nhs constitution for england how america's hospitals survived the first wave of the coronavirus remember the n mask shortage? it's still a problem exercise cygnus report tier one command post exercise pandemic influenza press release: new personal protective equipment (ppe) guidance for nhs teams up to % of staff tested at hospital after covid- patient contact had virus critical supply shortages the need for ventilators and personal protective equipment during the covid- pandemic spanish government faces legal action over lack of ppe for medics spain gears up to manufacture million masks a month as well as other vital covid- equipment stone, will, carrie feibel. . covid- has killed close to u.s. health care workers, new data from cdc shows care home staff could be asked to work without ppe under council plan the changing role of managers in the nhs king's fund department of health with powers derived from national health service act national health service and community care act implementing the code of conduct for nhs managers here's how some of the countries worst hit by coronavirus are dealing with shortages of protective equipment for healthcare workers covid- : the history of pandemics shortage of personal protective equipment endangering health workers worldwide who and countries are engaged in massive preparedness activities covid- news: uk could eliminate coronavirus entirely, say scientists national health service rationing: implications for the standard of care in negligence street on torts key: cord- -ag j obh authors: higgins, g.c.; robertson, e.; horsely, c.; mclean, n.; douglas, j. title: ffp reusable respirators for covid- ; adequate and suitable in the healthcare setting date: - - journal: j plast reconstr aesthet surg doi: . /j.bjps. . . sha: doc_id: cord_uid: ag j obh nan "please doctor, could you tell him that i love him?": letter from plastic surgeons at the covid- warfront dear sir, how many times have we heard these words in this time? too many. the covid- pandemic has completely disrupted our normal surgical and clinical routine. in these days, many colleagues of whatever specialty are regularly employed by their hospitals to face covid- emergency in italy, europe and worldwide. we are not plastic surgeons anymore. many of us feel lost, unprepared and inadequate for such an emergency. here in bergamo, the centre of the italian epidemic, we felt small and incompetent at the beginning. however, we must remember that first of all we are doctors, then plastic surgeons. in these weeks we are putting our willingness at the service of our patients and colleagues. the numbers of the covid- pandemic in bergamo are impressive: positive patients and over official deaths in about one month. at the same time, the reaction of our hospital, papa giovanni xxiii, has been impressive too: over doctors and over nurses entirely dedicated to covid- positive patients; intensive (one of the largest intensive care unit in europe) and over nonintensive care beds are set aside for those patients. this huge wave of covid- positive patients, forced the hospital management to progressively and rapidly recruit, train and put on ward over physicians of any discipline and nurses from march th. several training programs about covid- infection and management have been scheduled in order to prepare the entire staff. two plastic surgeons of our team (on a total of six) have been fully dedicated on the shifting in covid medical areas coordinated by a pulmonologist and an intensivist. main activities focus on patient clinical exam, adjustment of oxygen therapy, regulation of cpap systems, hemogasanalysis implementation, blood and radiological exam monitoring and consequent therapy modulation, admission, discharge and deaths bureaucracy. despite these new clinical fields which are new for a plastic surgeon, we are learning how isolation of patients, due to public health reason, is the most devastating aspect of covid- pandemic. , every single day we phone and update the relatives of those who, because of the worsening of their respiratory condition, are unable to speak and call home. we are sometimes those who communicate the death of his or her beloved but also those who bring words of hope, words of love: "please doctor, could you tell him that i love him so much?". some of these patients die without the hug of their families. a plastic surgeon is not usually used to face death because in our surgery it is not so frequent. we would say that the death of a lonely patient also takes a part of us away. it acquires a different hint, touching some inner cord, it makes you feel impotent and lost. as plastic surgeons we often take care of the psychological side of patients and, except for some tumours and traumas, the pathologies we treat -like breast reconstruction -are not fatal diseases. if we compare the contribution of plastic surgery department in term of numbers, we are like a drop in the ocean. but as ovid wrote in epistulae ex ponto "gutta cavat lapidem" i.e. "the drop digs the rock". thanks to our support, a clinical physician is able to evaluate a larger number of patients, focusing on the most critical ones. this is why we keep going on. we want to make our part, working with commitment, dedication and professionalism and assisting all our patients to the best of our in-continueupdating knowledge. we are proud to help bergamo community to face covid- emergency and trying to make the difference in our wounded city. we hope this letter will help other colleagues not to consider themselves unprepared or unready. the contribute of everyone is crucial to defeat this ongoing pandemic which has not only upset our clinical routine, but it has woken us up from our everyday life. before covid- everything was scheduled, now there are no plans and we are not sure about our priorities. only if we behave, as long as necessary, with the awareness of being able to make a difference, we will win this terrible fight against sars-cov- . only together we will go back to hugging, kissing and loving each other. when the critical phase of this emergency is over, it will be necessary to think deeply about the socioeconomic development strategies to discover new horizons and new opportunities for a better future. we will never give up!…and what about you? are you ready to play your part? none. this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. dear sir, covid- is a novel coronavirus with increasing outbreaks occurring around the world. , during the past weeks, emergence of new cases has gradually decreased in china with the help of massive efforts from society and the government. in addition to those directly working in the respiratory, infectious, cardiology, nephrology, psychology, and icu departments and covid- patients, all members of the general population may encounter the new coronavirus. medical staff in plastics, reconstructive, and other departments also have a responsibility to prevent the disease spreading in our community. in order to protect both patients and medical staff, selective operations and cosmetic treatments were reduced or postponed in the plastic surgery hospital, beijing, china. gloves and medical masks were saved and donated to the doctors and nurses in wuhan as the demand for protective equipment increased significantly. in addition, a standard operation procedure for covid- was proposed in local hos-pitals. our hospital recommended online consultations to replace face-to-face interactions. hospital websites and official social media accounts provided updated practical disease prevention information instead of plastic surgery information. other colleagues also conducted publicity campaigns on disease prevention online via their own social media accounts for relatives and friends, especially for older persons who appeared to have developed a serious illness. at the early stages of the covid- outbreak in certain areas, the public may not care much about the new disease. as more information about covid- becomes available, people without medical background may be anxious to seek diagnosis, which may result in potential risks of cross infection in the crowded fever clinics. thus, proper information and guidance can help reduce their panic and anxiety. moreover, if individuals were exhibiting relevant symptoms with epidemiologic history, they were advised to seek medical care following the directions of local health authority. in general, plastic surgeons are particularly good at introducing novel surgical methods to the public and keeping in touch with a great number of patients. as a result, they may be able to present local health authority advice in the form of straightforward images and accessible videos, as well as promote practical information via personal social media or clinic websites. in addition to local doctors and nurses from other departments helping in fever clinics and isolation wards, , (as of march , ) members of medical staff from other provinces rushed to help their colleagues in hubei province. plastic surgeons that had completed icu training in beijing and other cities supported wuhan on their own initiative as well. we suggest that measures should be taken by medical staff from all departments to help slow further spread and to protect health systems from becoming overwhelmed. dear sir, as covid- spreads quickly from asia via europe to the rest of the world, hospitals are evolving into hot zones for treatment and transmission of this disease. with the increasing acceptance that operating theatres are high risk areas for transmission of respiratory infections for both patients and surgeons, and with our health care systems being generally well-designed to only deal with occasional high-risk cases, there is an obvious need to evolve our practice. although social media campaigns via the british association of plastic, reconstructive and aesthetic surgeons (#staysafestayhome) and british society for surgery of the hand (#playsafestaysafe) are attempting to raise awareness and reduce preventable injuries, we are still seeing a steady stream of patients present to our plastic surgery trauma service. we have had to act immediately so our systems can support essential surgical care while protecting patients and staff and conserving valuable resources. as a department we have developed a set of standard operating procedures which cover the full scope of plastic surgery from the facilitation of emergent life and limb saving surgeries, rationalised oncological management to the management of minor soft tissue and bony injuries. we have been cognisant of the need to reduce footfall to the hospital and the stratification into "dirty" and "clean" areas with attempted segregation of non-, suspected and confirmed covid cases within inpatient clinical areas. this has resulted in displacement of assessment and procedure rooms within the unit. the ward itself has been earmarked as an extended intensive care unit due to its layout and facilities. standards of practise have changed, with an emphasis on "see and treat" as operating theatre availability has been reduced due to the reduced availability of nurses and theatre staff and their conversion into intensive care areas for ventilated patients. there is also an emerging assumption that all patients are covid- positive until proven otherwise. the combination of unfamiliar environments, lack of accessible equipment, requirement to reduce time spent with patients and adherence to social distancing has resulted in the need to provide a more mobile and flexible service. in order to support our mobile service, we have found that, as in other disaster situations where specialised bags have been deployed, using a simple bag containing essential equipment and consumables has revolutionised our ability to work at the point of referral and avoid unnecessary trips to theatre. despite their simplicity, bags have been fundamental for the development of human civilization, with the word originating from the norse word baggi and comparable to the welsh baich (load, bundle)!!! our portable "pandemic pack" is now being carried by the first on-call in our department. this pack contains a l ultra dry adventurer tm , polymer dry bag measuring cm (w) × cm (l) as shown in figure . the contents are shown in figure . we have found this adequate for managing most common plastic surgery trauma and emergency scenarios. the bag is easily cleaned with ppm available chlorine (in accordance with public health england guidance) after each patient exposure. we have found it useful to make up two packs in advance so that one is available at handover whilst the other is replenished by the outgoing team. we are sure that this concept has been used elsewhere, but if it is not common practice in your unit, we would advo- cate implementing such a toolkit to facilitate management of trauma patients and reduce the amount time frontline staff need to be in a potential "dirty" environment during the covid- pandemic. teleconsultation-mediated nasoalveolar molding therapy for babies with cleft lip/palate during the covid- outbreak: implementing change at pandemic speed dear sir, cleft lip/palate is among the most common congenital anomalies, requiring multidisciplinary care from birth to adulthood. the nasolaveolar molding (nam) revolutionized the care provided to babies with a complete cleft, with proving its benefits to patients, parents, clinicians, and society. this therapeutic modality requires parents' engagement with nam care at home and continuous clinicianpatient/parent encounters, commencing at the second week of life and finishing just before the lip repair. the rapidly expanding covid- pandemic has challenged clinicians who are dealing with nam therapy to fully stop it, or adjust it to protect, both, the patient/parent and the healthcare team. based on the current who recommendation, to maintain social distancing, and the national regulation for the use of telemedicine, , the nam-related clinician-patient/parent relationship has timely been adjusted by implementing the non-face-to-face care model. babies with clefts are consulted individually by clinicians, proactively establishing the initial and subsequent telemedicine consultations, also providing an open communication channel for parents. based on a shared decisionmaking process, all parents have the option to completely stop nam therapy or use only lip tapping. given that each patient is at a particular stage within the continuum of nam care, numerous patient-and parent-derived issues are being addressed by video-mediated consultations. overall, this has helped explain the current covid- -related public health recommendations and precautions to parents, while addressing patients' needs and parents' feelings, fears, expectations, and answering parents' questions. moreover, clinical support is provided to patients and parents by visual inspection (looking for potential nam-derived facial irritation), and checking parents' hand-hold maneuvers, such as feeding and placement of the lip tapping and nam device, with immediate feedback for corrections. thus, the use of an audiovisual communication tool has considerably reduced the number of in-person consultations. when a face-to-face consultation could not be resolved using the telemedicine triage, an additional video-based conversation had been implemented, focusing on the key steps, established for patient/parent visits to the facility (i.e., frequent hand-cleaning, mask usage, and keeping m social distance) and on the covid- -focused screening. symptom-and exposure-screened negative parents/babies have been consulted in a time-specific scheduling with minimum waiting time to avoid crowded waiting rooms, by a clinician wearing personal protective equipment (cap, face shield, n mask, goggles, gloves, and gowns), and working in an environment with constant surface/object decontamination. parents, who screened positive for symptoms (e.g., fever, cough, sore throat), were indicated to follow to the appropriate self-care or triage mechanism, stipulated by the who guidelines and local authorities. [ ] [ ] [ ] [ ] in the covid- era, the care provision should be aligned with the latest clinical evidence. in response to the constantly changing needs, clinicians across the globe could adapt the telemedicine-based possibilities to their own environment of national/hospital regulatory bodies, technology accessibility, and the parents' level of technological literacy. as most of the issues addressed in the video conversations were recurrent reasons for consultations prior to the covid- outbreak, future investigations could assist in truly defining the key aspects of telemedicinebased clinician-patient/parent relationship in delivering nam therapy, and its impact on nam-related proxy-reported and clinician-derived outcome measures. there are no conflicts of interest to disclose. virtual clinics: need of the hour, a way forward in the future. adapting practice during a healthcare crisis the whole world is gripped by the novel coronavirus pandemic, with huge pressures on the health services globally. within the coming days, this is only going to increase the pressure on the health care services and needs robust planning and preparedness for this unprecedented situation, lest the whole system may cripple and we may see unimaginable mortalities and suffering. the whole concept of social distancing and keeping people in self isolation has reduced footfall to the hospitals but this is affecting delivery of routine care to patients for other illnesses in the hospital and telehealth is an upcoming way to reduce the risk of cross contamination as well as reduce close contact without affecting the quality of health care delivered. at the bedford hospital nhs trust, for the past one year we have been running a virtual clinic for our skin cancer suspect patients, where in after a particular biopsy if the clinical suspicion of a malignancy was low, these patients were not given a follow up clinic appointment and instead they were informed of the biopsy result through post, sent both to their gp and themselves. most patients encouraged this model to not have to come back to an appointment and this took significant pressure off our clinics. in the event we needed to see a patient, they were informed via a telephonic conversation to attend a particular clinic appointment. from an administration standpoint, this resulted in less unnecessary follow up appointments in our skin cancer follow up clinics, which could then be offered to our regular skin cancer follow up patients as per the recommended guidelines, without having to struggle with appointments. virtual clinics have previously shown to be safe and cost effective alternatives to the out patient visits in surgical departments like urology and orthopedics. they improved performance as well as improved economic output. , we have increased the use of these virtual clinics, with the onset of the novel coronavirus pandemic, in order to reduce the patient footfall to our clinics. most patients voluntarily chose not to turn up and with the risk being highest amongst the elderly, it was logical to keep them away from hospitals as far as possible. in order to achieve this, we have started virtual clinics for nearly all patients in order to triage patients that can do without having to come to the hospital for now. the world of telemedicine is the way forward in nearly all aspects of medical practice and this pandemic situation might just be the right time to establish such methods. we propose setting up of more such clinics in as many subspecialties of plastic surgery, which not only will help in the current crises situation, but will also be useful in the future to take pressure of our health care services. none declared not required funding none webinars in plastic and reconstructive surgery training -a review of the current landscape during the covid- pandemic dear sir, the covid- pandemic has resulted in cancellation of postgraduate courses and the vast majority of elective surgery. plastic surgery trainees and their trainers have therefore needed to pursue alternative means of training. in the face of cross-speciality cover and redeployment there is an additional demand for covid- specific education. the joint committee on surgical training (jcst) quality indicators for higher surgical training (hst) in plastic surgery state that trainees should have at least h of facilitated formal teaching each week. social distancing requirements have meant that innovative ways of delivering this teaching have needed to be found. a seminar is a form of academic instruction based on the socratic dialogue of asking and answering questions, with the word originating from the latin word seminarium meaning "seed plot". fast and reliable internet and the ubiquitous nature of webcams has led to the evolution of the seminar into the webinar. whilst webinars have been common place for a number of years, they represent an innovative and indispensable tool for remote learning during the covid- pandemic, where trainees can interact and ask questions to facilitate deep and meaningful learning. speciality and trainee associations have traditionally used their websites and email lists to publicise training opportunities. however, the covid- pandemic has seen a shift to social media; with people seeking constant updates and information from public figures, brands and organisations alike. surgical education has mirrored this trend, and we have increasingly observed that webinars are being launched through speciality and trainee association social channels to keep up with the fast-paced demand for accessible online content. the aim of this study was to audit cumulative compliance of active publicly accessible postgraduate plastic surgery training webinar frequency and duration against jcst quality indicators. we used the social listening tool brand tm ( https:// brand .com ). this tool monitors social media platforms for selected 'keywords' and provides analysis of search results. we used the search terms "plastic surgery webinar", "reconstructive surgery webinar", "royal college of surgeons", "bapras", "bssh", "british burns association", "plasta" and "bssh". there were mentions of these terms from th may to th may and of these were after rd march , the date that lockdown began in the united kingdom (uk). this represents an increase of , % post-lockdown. we supplemented this search strategy by searching google tm and youtube tm with "plastic and reconstructive surgery webinar". these search engines rank results in order of relevance using a relevancy algorithm, we therefore reviewed the first results only. additional webinars were identified through a snowballing technique where the host webinar webpage was searched for advertised webinars at other institutions. we included any educational webinar series aimed at trainees that was free to access, mirroring weekly plastic surgery hst teaching. free webinars which required membership registration were also included. we excluded webinars aimed at patient or parent education, webinars with less than one video, any historic webinar that did not have an accessible link and webinars behind a paywall or requiring paid membership. we systematically reviewed the search results from brand tm , google tm and youtube tm and identified webinar series currently in progress ( table ) and historic webinar series ( table ) . seven active webinar series and two historic webinar series were identified respectively. all were consultant or equivalent delivered. of the active webinar series, ( %) related to covid- , ( %) related to aesthetic surgery, ( %) related to pan-plastic surgery and ( %) related to hand surgery. the weekly total running time for active webinars amounted to h min, with h and min plastic surgery specific. this was a surplus of h min to jcst quality indicators. limitations of this study include us only identifying webinars advertised publicly. we are aware of training pro-grammes in the uk running in-house webinar series to supplement training and therefore the total available for training is likely to be higher than we have identified. we have also not reviewed the quality of educational content. we acknowledge there are good quality webinar series that require paid for membership such as those provided by the british association of aesthetic plastic surgeons and american society of plastic surgeons but it was not the aim of the study to present them here. innovation flourishes during times of crisis. the education of surgical trainees is of paramount importance and should be maintained, even during the difficult times we currently face. while operative skills will be difficult to develop, the use of technology can allow for the remote delivery of expert teaching to a large number of trainees at once. in this study we identify a number of freely available webinar series that provide a greater number of teaching hours than is recommended by the jcst. the training exists, it is up to trainees to make the most of it. none. none. dear sir, salisbury district hospital (sdh) is based in southwest england and provides a plastic surgery trauma service across the south coast, serving six local hospitals and the designated major trauma centre (mtc). prior to the covid- pandemic all patients referred to the trauma service, apart from open lower limb trauma, were reviewed in person within the trauma clinic. if surgery was required, it was usual for patients to return on a separate day for their operation and in most instances this was carried out under general anaesthetic in the main operating theatres. after discharge, patients were referred to the hand therapy and plastics dressing services and returned in person for all follow-up visits including dressing changes and therapy. patients with lower limb injuries from the mtc were transferred from southampton general hospital as inpatients to sdh for all complex reconstruction including free tissue transfer. at the start of the covid- crisis, it became quickly apparent that reducing patient footfall within our department was necessary to protect both patients and staff from the disease. this included reducing inpatient stays in hospital. we responded to this challenge in the following ways and hope that our experience will be of assistance to other trauma services over the course of the global pandemic. firstly, all patient protocols underwent significant redesign following which changes to the layout of our plastic surgery outpatient facility were made and patient flow through the department was altered and reduced. now, when patients are referred to our hand trauma service from peripheral hospitals, the initial patient consultations are carried out remotely using the 'attend anywhere' video platform. we are following the bssh covid- hand trauma guidelines for patient management. all patient decisions are discussed with the trauma consultant of the day. we are managing a greater number of patients conservatively and to aid this we have designed comprehensive patient information leaflets that enable our patients to increase understanding of their own management. patients who need to be seen in person at our department are screened for symptoms of covid- and their temperature taken at the department entrance. level ppe is worn by staff at all times. for hand trauma patients requiring surgery, this is provided on the same day to maximize efficiency and reduce the need for multiple visits. we have transformed our minor operating theatres, located adjacent to our clinic, into fully functional theatres equipped with a mini c-arm and all instruments for trauma operating. this reduces the need for our patients to be taken into the main hospital theatre suite. operations are carried out either under local anaesthetic, walant or regional block depending on complexity. all theatre staff wear level ppe and staffing is kept to a minimum. all wounds are closed with dissolvable sutures. immediately post operation, our on-site hand therapists review patients. splints are made on the same day and patients are educated about their post-operative management at this time. all follow-up is subsequently carried out virtually by the hand therapy team using 'attend anywhere'. with our hub and spoke service set up for lower limb trauma patients, we have ensured that there is an on-site consultant at the mtc every day. wound coverage is being undertaken for all patients at the mtc. two plastic surgery consultants in conjunction with the orthopaedic team carry out operating for these patients. all inter-hospital transfers for this group of patients have been stopped. choice of wound coverage for these patients is being designed to minimise inpatient stay and reduce operative time. the changes that we have made to our service in a short period of time have already been beneficial for patients, streamlining their care and reducing time spent in hospital. figure shows the drop in numbers of trauma patients that we have seen during the first four weeks of the uk lockdown ( n = in january to n = over the first weeks into lockdown). this is in line with reports from other uk units. this has given us time to refine our protocols for an expected upsurge of patients as the lockdown is lifted. furthermore, during this period where we have had extra capacity, our registrars have been trained to carry out new techniques. they now undertake insertion of both mid-lines and picc lines for medical inpatients under ultrasound guidance to support and reduce the burden placed on our anaesthetic and critical care colleagues who previously would have placed these. it is our expectation that many of the changes we have implemented to our service will be continued in the longterm. we will continue to learn and adapt our protocols as this phase of work continues. whilst many of the outcomes of the covid- pandemic will be negative, it has also been the catalyst for significant positive change within the uk nhs. dear sir, the covid- pandemic has caused unprecedented disruptions in patient care globally including management of breast and other cancers. however, cancer care should not be compromised unnecessarily by constraints caused by the outbreak. clinic availability and operating lists have been drastically reduced with many hospital staff members reassigned to the "frontline". furthermore, all surgical specialties have been advised to undertake emergency surgery or unavoidable procedures only with shortest possible operating times, minimal numbers of staff and leaving ventilators available for covid- patients. in consequence, much elective surgery including immediate breast reconstruction (ibr) has been deferred in accordance with guidance issued by professional organisations such as the association of breast surgery (uk) and the american society of plastic surgeons. , this will inevitably lead to backlogs of women requiring delayed reconstructions and it is therefore imperative that reconstructive surgeons consider ways to mitigate this and adapt local practice in accordance with national guidelines and operative capacity. in the context of the current "crisis" or the subsequent "recovery period", time consuming and complex autologous tissue reconstruction (free or pedicled flap) should not be performed. approaches to breast reconstruction might include the following options: . a blanket ban on immediate reconstruction, and all forms of risk-reducing, contralateral balancing and revisional/tertiary procedures. where reconstructive delay is neither feasible nor desirable, opting for simple and expedient surgery should be considered e.g.: a) expanded use of therapeutic mammaplasty: as a unilateral procedure in selected cases instead of mastectomy and ibr. b) exploring less technically demanding (albeit "controversial") implant-based forms of ibr: i. epipectoral breast reconstruction (fixed volume implants): this adds about minutes to the ablative surgery as the pre-prepared implant-adm complex is easily secured with minimal sutures. ii. "babysitter" tissue expander/implant: this acts as a scaffold to preserve the breast skin envelope for subsequent definitive reconstruction. . during the restrictive and early recovery phase, either a solo oncological breast surgeon or a joint ablative and reconstructive team (breast and plastic surgeon) performs surgery without the assistance of trainees or surgical practitioners. for joint procedures, the plastic surgeon acts as assistant during cancer ablation and as primary operator for the reconstruction. despite relatively high rates of complications for implant-based ibr (risking re-admission, prolonged hospital stays or repeat clinic visits), avoiding all ibr will lead to long waiting lists and have a negative psychological impact, particularly among younger patients. this will also impair aesthetic outcomes due to more extensive scars and inevitable loss of nipples. whilst appreciating the restrictions imposed by covid- , there is opportunity to offer some reconstructive options depending on local circumstances, operating capacity and the pandemic phase. we suggest that these proposals involving greater use of therapeutic mammaplasty as well as epipectoral and "babysitter" prostheses be considered in efforts to offset some of the disadvantages of covid- on breast cancer patients whilst ensuring that their safety and that of healthcare providers comes first. dear sir, the covid- pandemic has shifted clinical priorities and resources from elective and trauma hand surgery with general anaesthesia (ga) to treat the growing number of covid patients. at the time of this correspondence, the pandemic has affected over million people resulting in deaths worldwide, with uk deaths, with numbers still climbing. this has particularly affected our hand trauma services which serves north london, a population of more than million. we receive referrals from a network of hospitals in addition to emergency departments of the royal free group of hospitals and numerous gp practices and urgent care centres. in the first week following the british government lockdown, which commenced march rd, we experienced a % drop in referrals, from to a day. subsequently, numbers have been steadily rising to - a day by th of april. the british association of plastic, reconstructive and aesthetic surgeons, the british society for surgery of the hand and the royal college of surgeons of england, have all issued guidance: both encouraging patients to avoid risky pursuits, which could result in accidental injuries and to members how to prioritise and optimise services for trauma and urgent cancer work. we have adapted our hand trauma service to a 'one stop hand trauma and therapy' clinic, where patients are assessed, definitive surgery performed and offered immediate post-operative hand therapy where therapists make splint and give specialist advice on wound care and rehabilitation including an illustrated hand therapy guide. patients are categorised based on the bssh hand injury triage app. we already have a specific 'closed fracture' hand therapy led clinic, to manage the majority of our closed injuries. we combined this clinic with the plastic surgeons' led hand trauma clinic, and improved its efficiency further by utilising the mini c-arm fluoroscope within the clinic setting. this enabled us to immediately assess fractures and perform fracture manipulation under simple local anaesthesia. we have successfully been able to perform % of our operations for hand trauma under wide awake local anaesthesia no tourniquet (walant). prior to the pandemic, we used walant for selected elective and trauma hand surgical cases. in infected cases, where local anaesthesia is known to be less effective, we have used peripheral nerve blocks. previous data showed % of our trauma cases were conducted under ga, % under la, and % under brachial or peripheral nerve blocks. we have specifically modified our wound care information leaflets to minimise patient hospital attendance. afterwards patients receive further therapy phone consultations and encouragement to use the hand therapy exercise app developed by the chelsea and westminster hand therapists. the patient is given details of a designated plastic surgery nhs trust email address, for direct contact with the plastic surgery team: for concerns, questions and transfers of images. we have to date received emails, of which have been from patients directly, and the remainder from referring healthcare providers. the majority of inquiries are followed up via a telephone consultation and only complex cases or complications, attend face-to-face follow-up. this model has successfully combined assessment, treatment and post-op therapy into a one-stop session, which has greatly limited patient exposure to other parts of the hospital, such as the radiology and therapy departments. the other benefit of such clinic is an improved outcome through combined decision making. there is also a cost saving benefit compared to our traditional model of patient care. we have treated patients based on this model so far, who have been suitable for remote monitoring. on average we have saved plastics dressing clinic (pdc) visits for wound checks per patient, as a very minimum. we have previously calculated the cost of pdc at our centre at £ per visit and for our patients this translates to an approximately saving of £ per month just on pdc costs. if patients each month could be identified for remote monitoring, this could potentially lead to an annual saving of more than £ , . in addition, the estimated cost-saving by converting the mode of anaesthesia from ga to walant has been shown to cause a % reduction. the concept of a one-stop clinic has already been successfully implemented in the treatment of head & neck tumours, following introduction of nice guidelines in and the covid- pandemic has made us redesign a busy metropolitan service for hand injuries along the same lines. we believe this model is a good strategy and combining this with more widespread use of the walant technique, technology such as apps and telemedicine, as well as encouraging greater patient responsibility in their post-operative care and rehabilitation; is the way forward. we hope sharing this experience will result in improved patient care at this time of crisis. 'this is a saint patrick's day like no other' declared the irish prime minster on march th , whilst announcing sweeping social restrictions in a response to the worsening covid- pandemic. this nationwide lockdown involved major restrictions on work, travel and public gatherings and signified the government's shift from the suppression to the mitigation phase of the outbreak. the national covid- task force produced a policy specifying the redeployment of heath care workers to essential services such as the emergency department and intensive care. with the introduction of virtual outpatient clinics and the curtailment of elective operating lists, the apparent clinical commitments of a plastic surgeon during this pandemic has lessened. trauma is a continual and major component of our practice ; however, a decline in emergency department presentations has fuelled anecdotal reports of a reduction in the trauma workload. with diminishing resources, the risk of staff redeployment and consequences of poor patient outcomes we aim to assess the effect of the current lockdown due to covid- pandemic on plastic trauma caseload. we performed a retrospective review of a prospectively maintained trauma database at a tertiary referral hospi- during the first days of the lockdown, patients attended plastic surgery trauma clinic, in which ( . %) underwent a surgical procedure. as seen in figure , these numbers are comparable over the same time frame for the two previous years. upper limb trauma accounted for the near majority of referrals. frequency and type of surgery performed during the lockdown were similar to the previous two years, as seen in table . the percentage of patients requiring general anaesthesia was . % ( / ) in , . % ( / ) in , and slightly higher in at . % ( / ). we have refuted any anecdotal evidence proposing a decline in plastic trauma caseload during the covid nationwide lockdown. comparing the same time in previous years, the lockdown has produced an equivalent trauma volume. despite, the widespread and necessary restriction of routine elective work, somewhat surprisingly the pattern and volume of trauma remains similar to preceding years. with people confined to their household, it is the 'diy at home' associated injuries which attributes to this trend. and the exemption from regulations of certain industries such as agriculture and the food preparation chain. whilst not every trauma risk may be mitigated, the potential for these diy injuries to overwhelm the healthcare service has resulted in the british society for surgery of the hand (bssh) cautioning the general public on the safety of domestic machinery. as healthcare systems are stretched further than ever before we all must recognise the need for adaptation and structural reorganisation to treat those of our patients most in need during this pandemic. staff redeployment is a necessary tool to maintain frontline services; nonetheless, we wish to highlight the outcomes of this study to the clinical directors with the challenging job of allocating resources. our trauma presentations have not reduced during the first days of this pandemic, resources (staff and theatre) should still be accessible for the plastic surgery trauma team, with observance of all the appropriate risk reduction strategies as documented by british association of plastic, reconstructive and aesthetic surgeons. none. none. in light of the ongoing covid- pandemic, the american society of plastic surgeons (asps) has released a statement urging the suspension of elective, non-essential procedures. this necessary and rational suspension will result in detrimental financial effects on the plastic surgery community. given the simultaneous economic downturn inflicted by public health social-distancing protocols, there will be a bear market for elective surgery lasting well past the bans being lifted on elective surgeries. this effect will largely be due to the elimination of discretionary spending as individuals attempt to recover from weeks to months of lost earnings. as demonstrated during the - recession, economic decline was associated with a decrease in both elective and non-elective surgical volume. private practice settings performing mostly cosmetic procedures were particularly vulnerable to these fluctuations and demonstrated a significant positive correlation with gdp. the surgery community must prepare for the economic impact that this pandemic will have on current and future clinical volumes. these effects are likely to be more severe than the previous recession as surgeons are currently indefinitely unable to perform elective surgeries, coupled with the immense strain on hospital resources at this time. given this burden, elective surgery cases may be some of the last to be added back to the hospital once adequate resources are restored. while surgeons are temporarily unable to operate, they do have the potential to use telehealth in order to arrange preoperative consults and postoperative follow-up appointments. this could be accomplished in private practice settings with the use of telehealth services such as teladoc health, american well, or zoom, which allow for live consultation with patients without unnecessary exposure of patients or providers to potential infection. the main limitation of these types of appointments is the lack of an inperson physical exam, so providers have found that billing based on time spent with the patient is more effective with this tool. this could generate revenue and facilitate future surgical cases after the suspension of in-person elective patient care has been lifted. several strategies should be considered by the elective surgery community to minimize financial losses. many financial entities have changed their policies in order to support small businesses. examples include the small business administration offering expanded disaster impact loans and deferment of the federal income tax payments by three months to july . another option employers may leverage is temporarily laying off of employees so that employees can apply for and collect an expanded unemployment package by federal and state governments thereby reducing the payroll burden on stagnant practices with no cash flows and providing employees with a steady source of income during the pandemic. the employer's incentive to do this may be reduced with the potential suspension of the payroll tax on employers and loan forgiveness to employers who continue to pay employees wages. once elective procedures are again permitted, plastic surgeons that have retained a reconstructive practice should make a strategic business decision to increase reconstructive surgery and emergent hand surgery bookings as historically these procedures are less fluctuant with the economy. other options to maintain aesthetic case volume include price reductions or temporary promotions. however, it is important that these be adopted universally in order to minimize price wars between providers. as physicians, it is principle that surgeons practice nonmaleficence and minimize non-essential patient contact for the time being. however, this time of financial standstill should be used constructively to prepare for the financial uncertainty in the months to come. none demic advise certain groups to stringently follow social distancing measures. inevitably some health care workers fall into these categories and working in a hospital places them at high risk of exposure to the virus. studies have shown human to human transmission from positive covid- patients to health care workers demonstrating that this threat is real , and as in other infectious diseases is worse in certain situations such as aerosol generating and airway procedures , . there is therefore a part of our workforce that has been out of action reducing available workforce at a time of great need. in our hospital a group of vulnerable surgical trainees ranging from ct to st , and also consultants, have been able to keep working while socially isolating within their usual workplace. in light of covid- our hospital, a regional trauma centre for burns, plastic surgery and oral and maxillofacial surgery, was reorganized to increase capacity for both trauma and cancer work. as part of this a virtual hand trauma service has been set up. the primary aim of the new virtual hand trauma clinic was to allow patients to be triaged in a timely manner while adhering to social distancing guidelines by remotely accessing the clinic from home. further aims were to reduce time spent in hospital and reduced time between referral and treatment. in brief, patients referred to our virtual hand trauma clinic from across the region receive a video or telephone consultation using attend anywhere software, supported by nhs digital. following the virtual consultation patients are then triaged to theatre, further clinic, or discharged. our group of isolating doctors, plus a pharmacist and trauma coordinator, have been redeployed away from their usual face to face roles and are now working solely in the virtual trauma clinic. they are able to work to provide this service in an isolated part of the hospital named the 'virtual nest.' the nest is not accessible in a 'face to face' manner by non-isolating staff or patients. this allows a safe 'clean' environment to be maintained. the virtual team is able to participate in morning handover with other areas of the hospital via video conferencing using webex software. the nest workspace is large enough to allow social distancing between clinicians and by being on site they benefit from availability of dedicated workspaces with suitable it equipment and bandwidth. it is widely recognised that reconfiguration of hospitals and redeployment of staff has meant that training is effectively 'on hold' for many trainees. we have found that a benefit of the new virtual hand trauma clinic is that trainees can continue to engage with the intercollegiate surgical curriculum programme with work based assessments in a surgical field. while direct observation of procedural skills and procedure based assessment are not feasible, case based discussions and clinical evaluation exercises have been easily achievable due to trainees managing patients with involvement of supervising senior colleagues in decision making. this plus a varied case mix seen has enhanced development of knowledge, decision making, leadership and communication skills. as trainees are unable to attend theatre practical skills may suffer depending on how long clinicians are non patient facing. this has been acknowledged by the gmc in the skill fade review; skills have been shown to decline over - months . although it can only be postulated at the current time colleagues who are patient facing but redeployed may face a similar skill decline. the structure of the team is akin to the firm structure of days gone by with the benefits that brings in terms of support and mentorship. patients benefit from having access to a group of knowledgeable trainees, supported by consultants, and a service accessible from their own home. this minimizes footfall within our hospital, exposure to, and spread of covid- . local assessment of our practice is ongoing but we have found that this model has enabled a cohort of vulnerable plastic surgery trainees to successfully continue to work whilst reducing the risk of exposure to covid- and providing gold standard care for patients. none. nothing to disclose. dear sir, a scottish sarcoma network (glasgow centre) special study day on th march at the school of simulation and visualisation, glasgow school of art, with representatives from sarcoma uk, beatson cancer charity and the bbc. traditional patient information leaflets inadequately convey medical information due to poor literacy levels: - % of uk population have the lowest adult literacy level and % the lowest "health literacy" level (ability to obtain, understand, act on, and communicate health information). it was hypothesised that an entirely visual approach, such as ar, may obviate literacy problems by faciliating comprehension of complex dimensional concepts integral to reconstructive surgery. we report the first augmented reality (ar) in patient information leaflets in plastic surgery. to our knowledge we are among the first in the world to develop, implement, and evaluate an ar patient information leaflet in any speciality. developed for sarcoma surgery, the ar patient leaflet centred around a prototypical leg sarcoma. a storyboard takes patients through tumour resection, reconstruction, and the potential post-operative outcomes. input from specialist nurses, sarcoma patients, and clinicians during a scottish sarcoma network special study day in march informed the final content ( figure ). when viewed by smartphone camera (hp reveal studio, hp palo alto, california usa), photos in the ar leaflet automatically trigger additional content display without need for qr codes or internet connectivity: ( ) sequential tumour resection ( a d alt flap model was developed using body-parts d (research organization of information and systems database centre for life science, japan) and custom anatomical data. leaflet evaluation by consecutive lower limb sarcoma patients was exempted from ethics approval by greater glasgow and clyde nhs research office as part of service evaluation. ar leaflets were compared with pooled data from traditional information sources (sarcoma uk website patient leaflets ( ), self-directed internet searches ( ), generic sarcoma patient leaflets ( ); some patients used > source). the mental effort rating scale evaluated perceived difficulty of comprehension (or extrinsic cognitive load), as a key outcome measure in comparison to traditional information sources. patient satisfaction was assessed by likert scale ( was very, very satisfied and very, very dissatisfied). statistical analysis performed with social science statistics, . ar leaflets were rated as . (very, very low mental effort), traditional information sources as . (high mental effort) [unpaired t -test p < . ]. likert-scale satisfaction was . , indicating a very, very high satisfaction. when asked "do you think the ar leaflet would make you less anxious about surgery?", / ( %) patients responded 'yes'. when asked "would you think other patients would like to have a similar ar leaflet before surgery" and "would you like to see further ar leaflets to be developed in the future?", % responded "yes". no correlation was found between age or educational level and mental effort rating scale scores for ar patient leaflet (data not shown). subjective feedback analysis found that self-directed internet searches had too much unfocussed information: " (i) didn't want to google as may end up with all sorts" and "(there is) good and bad stuff on the internet, don't know what you're looking at". all patients felt the visual content in ar leaflets helped their understanding: "incredible…that would have made a flap easier to understand", "tremen-dous… good way of explaining things to my family", "so much better seeing the pictures, gives an idea in your head", and "helpful for others with dyslexia". traditional patient leaflets were often difficult to comprehend: "(i) didn't fully understand the sarcoma leaflets", "couldn't take information in from leaflets". feedback recommended adding simple instructions on the leaflet, however the ar leaflet is intended for use by the clinician in clinic, and to be so simple that no instructions are required once software is downloaded to the patient's smartphone (i.e., point and shoot without technical expertise, menus, or website addresses). all patients desired an actual paper leaflet for reassurance, preferring something physical show their family rather than direction to a website or video. this study demonstrates significant reduction in extraneous cognitive load (mental effort required to understand a topic) with ar patient leaflets compared to traditional information sources ( p < . ). ar visualisation may make inherently difficult topics (intrinsic cognitive load), such as reconstructive surgery, easier to understand and process. significant learning advantages exist over tradi-tional leaflets or web-based videos, including facilitating patient control, interactivity, and game-based learning. all contribute to increased motivation, comprehension, and enthusiasm in the learning process. ar leaflets reduced anxiety ( % patients), and scored very highly for patient satisfaction with information, which is notable given increasing evidence of strong independent determination of overall health outcomes. this study provided impetus for investment in concurrent development of other ar leaflets across the breadth of plastic surgery, and non-plastic surgery specialties. chief scientist office (cso, scotland) funding was recruited to aid development of improved, free, fully interactive d ar patient information leaflets and a downloadable app. ethical approval is in place for a randomised controlled trial to quantify the perceived benefits of ar in patient education. our belief is that ar leaflets will transform and redefine the future plastic surgery patient information landscape, empowering patients and bridging the health literacy gap. none. dear sir, we investigated if age has an influence on wound healing. wound healing can result in hypertrophic scars or keloids. from previous studies we know that age has an influence on the different stages of wound healing. - a general assumption seems to be that adults make better scars than children. knowledge of the influence of age on healing and scarring can give opportunities to intervene in the wound healing process to minimize scarring. it could guide patients in their decision when to revise a scar. it could also lead patients and physicians in their decision of the timing of a surgery, if the kinds of surgery allows this. this study is a retrospective cohort study at the department of plastic, reconstructive, and hand surgery of the amsterdam university medical center. all patients underwent cardiothoracic surgery through a median sternotomy incision. all patients had to be at least one year after surgery at time of investigation. hypertrophic scars were defined as raised mm above skin level while remaining within the borders of the original lesion. keloid scars were defined as raised mm above skin level and extending beyond the borders of the original lesion. the scars were scored with the patient and observer scar assessment scale (posas) as primary outcome measure. as secondary outcome measures we looked at wound healing problems and scar measurements. in order to ensure that the results of this study are as little as possible influenced by the already known risk and protective factors for hypertrophic scarring, the patients were questioned about co-existing diseases, scar treatment, allergies, medication, length, weight, cup size (females) and smoking. their skin type was classified with the fitzpatrick scale i to vi. all calculations were performed using spss and the level of significance was set at p ≤ . . patients were enrolled in this study. group contained children and group contained adults. there is a significant difference between the two groups for the amount of pain in the scar scored by the patient. this item was given higher scores by adults than children ( p = . ). there is no significant difference between the two groups for the other posas items (itchiness, color, stiffness, thickness, and irregularity), the total score of the scar and the overall opinion of the scar scored by the patient ( table ) . there is a significant difference between the two groups in pliability of the scar scored by the observer. the posas item pliability of the scars of the children was assessed higher, thus stiffer, than in adults ( p = . ). there is no significant difference between the two groups for the other posas items (vascularization, pigmentation, thickness, relief, and surface), the total score of the scar and the overall opinion of the scar scored by the observer ( table ) . there is no significant difference between children and adults in the occurrence of wound problems post-surgery. there is no significant difference in scar measurements between children and adults. in children we found three hypertrophic scars and two keloid scars. in adults we found seven hypertrophic scars and three keloid scars. for both groups together that is a percentage of . hypertrophic and keloid scars ( table ) . patients with fitzpatrick skin type i and iv-vi scored significantly higher, thus worse, in their overall opinion of the scar ( p = . ) than patients with skin type ii and iii. observer and patient assessed the overall opinion of the scar significantly higher (worse) in people who had gone through wound problems (respectively p = . and p = . ) than those who had not. we found no significant differences in the primary outcome measure between men and women, cup size a-c and d -g, smokers and non-smokers, bmi < and bmi > , allergies and no allergies, and scar treatment and no scar treatment. age at creation of a sternotomy wound does not seem to influence the scar outcome. this is contrary to what is often the fear of a parent of a child who needs surgery early in life. comparing scars remains difficult because of the many factors that can influence scar formation. we found that scars have the tendency to change, even years after they are made. a limitation of the study is the retrospective design. the long follow-up period after surgery is a strength of the study. to our best knowledge this is the first study that compares scars of children and adults to specifically look at the clinical impact of age on scar tissue. in order to detect even more reliable and possibly significant differences between children and adults, more patients should be enrolled in future prospective studies. for now we can conclude that there is no significant difference in the actual scar outcome between children and adults in the sternotomy scar. if we extend these results to other scars, the timing of surgeries should not depend on the age of a patient. none. none. metc. reference number: w _ # . . we published a systematic review of randomized controlled trials (rcts) on early laser intervention to reduce scar formation in wound healing by primary intention. while comparing our results with two other systematic reviews on the same topic, , we identified various overt methodological inconsistencies in those other systematic reviews. issue . including duplicate data ( table ) : karmisholt et al. included two rcts of which both reported the identical data on five people. the inclusion of duplicate data can bias the results of a systematic review and should be prevented in the quantitative as well as the qualitative synthesis of evidence. abbreviations. id: identity; n.l.t.: no laser treatment; pcs: prospective cohort study; pmid: pubmed identifier; rct: randomized controlled trial. a) listed are rcts which were included by at least one of the three identified systematic reviews. the systematic reviews are ordered by search date from left to right. b) "search date" refers to the searching of bibliographic databases by the authors of the corresponding systematic reviews. c) "publication date" refers to the publication history status according to medline®/pubmed® data element (field) descriptions. d) "n.l.t." means that the authors of the rcts compared laser treatment with no treatment or a treatment without laser. e) "pcs" means that the authors used this term to label the corresponding rct. f) "-" indicates that an rct could not have been identified because the publication of the corresponding rct happened after the search date. g) "missing study" means that an rct could have been identified because the publication of a corresponding rct happened before the search date. h) "excluded" that the authors of the present review excluded the corresponding rct based on the exclusion criteria provided. i) "not analyzed" means that an rct was reported within an article but the corresponding data were not included in the metaanalysis. j) "other laser" means that the authors of the rcts compared various types of laser treatment. attached the label "prospective cohort" to almost all considered studies including rcts and seven nonrandomized studies. in rcts, subjects are allocated to different interventions by the investigator based on a random allocation mechanism. in cohort studies, subjects are not allocated by the investigator but rather allocated in the course of usual treatment decisions or peoples' choices based on a nonrandom allocation mechanism. we believe that 'cohort study' is certainly not an appropriate label for rcts. furthermore, it is known for a long time that the shorthand labeling of a study using the words 'prospective' and 'retrospective' may create confusion due to the experience that these words carry contradictory and overlapping meanings. issue . mixing data from various study designs: karmisholt et al. did not clearly separate randomized from nonrandomized studies. combinations of different study design features should be expected to differ systematically, and different design features should be analyzed separately. issue . unclear definition of outcomes and measures of treatment effect: kent et al. reported, quote: "the primary outcome of the meta-analysis is the summed measure of overall efficacy provided by the pooling of overall treatment outcomes measured within individual studies." we think that the so-called "summed measure" is not defined and not understandable. the meta-analysis reported in that article included mean and standard deviation values from four rcts. these rcts applied endpoints and time periods for assessment which differed considerably among the included studies. it appears obscure to us which data were transformed in what way to finally arrive in the meta-analysis. we believe that traceability and reproducibility of data analyses are mainstays of systematic reviews. issue . missing an understandable risk of bias assessment: kent et al. reported, quote: "the risk of bias assessment tool provided by revman indicated that all studies had - categories of bias assessed as high risk." the term "revman" is a short term for the software "review manager provided by cochrane for preparing their reviews. the cochrane risk-of-bias tool for randomized trials is structured into a fixed set of domains of bias including those arising from the randomization process, due to deviations from intended interventions, due to missing outcome data, those in measurement of the outcome, and in selection of the reported result. we believe that the risk of bias assessment reported by kent et al. is not readily understandable and presumably does not match standard requirements. systematic reviews of healthcare interventions aim to evaluate the quality of clinical studies, but they might have quality issues in their own right. the identification of various inconsistencies in two systematic reviews on plateletrich plasma therapy for pattern hair loss should prompt future authors to consult the cochrane handbook ( https: //training.cochrane.org/handbook ) and the equator network ( http://www.equator-network.org/ ). the latter provides information to various reporting standards such as prisma for systematic reviews, consort for rcts, and strobe for observational studies. the authors declare no conflict of interest. dear sir, journal clubs have contributed to medical education since the th century. along the way, different models and refinements have been proposed. recently, there has been a shift towards "virtual" journal clubs, often using social media platforms. our team has refined the face-to-face journal club model and successfully deployed it at two independent uk national health service (nhs) trusts in . we believe there are reproducible advantages to this model. over months at one nhs trust, journal club events were held, with iterative changes made to increase engagement and buy-in of the surgical team. overall, tangible outputs included submissions of letters to editors, of which have been accepted. following this, the refined model was deployed at a second nhs trust, which had expanded academic support increasing its impact. over months, journal club events were held, with submissions of letters to editors, of which have been accepted. thus, in months of , the two sequential journal clubs generated submissions for publication, with different authors. these tangible outputs are matched by other intangible benefits, such as improving critical appraisal skills. this is assessed in uk surgical training entry selection and is also a key skill for evidence-based professional practice. therefore, we feel this helps our team members' career progression and clinical effectiveness. key aspects of the model include: . face-to-face meetings continue to have multiple intangible benefits there is a trend towards social media and online journal clubs. while such initiatives have considerable benefits, maintaining face-to-face contact in a department allows for an efficient discussion, and enhances teambuilding. instead of replacing face-to-face meetings with virtual ones, we use social media platforms, such as whatsapp, to support our events. this includes communications to arrange the event in advance, and for maintaining momentum on post-event activities, such as authoring letters to journals from the discussion. while some articles describing journal club models highlight the benefit of expert input in article selection, we also view it as a learning opportunity. a surgical trainee is allocated to present each journal club, with one of our three academically appointed consultant surgeons chairing and overseeing. trainees are encouraged to screen the literature and identify articles beforehand and make a shared decision with the consultant. the article must be topical and have potential to impact clinical practice. doing this prior to the session allows the article to be circulated to attendees with adequate time to read it. we routinely use both reporting guidelines (e.g., prisma for systematic reviews), and also methodological quality guidance (e.g., amstar- for systematic reviews) to guide trainees and structure the journal club presentation. in addition to three consultants with university appointments guiding critical appraisal, a locally based information scientist also joins our meetings. during journal club discussion, emphasis is placed on relating the article to the clinical experience of team members. this provides context and aids clinical learning for trainees. while undertaking critical appraisal may be a noble endeavour, in busy schedules, it is important that it adds value for everyone involved. reviewing contemporary topics can inform clinical practice for all levels of surgeon in the team, presenting the article improves trainees' presentation skills, and publishing the appraisal generates outputs that help trainees to progress. . publishing summaries of journal club appraisals can impact on multiple levels journal club does not only contribute to our trainees' development and departmental clinical practice. it benefits our own research strategy and quality, and open discussion of literature in plastic surgery contributes to a global culture of improving evidence. scheduling events on a regular basis increases familiarity with reporting and quality guidance and allows for the study of complementary article types (e.g., systematic review, randomised trial, cohort study). our iterations suggest that the following structure is most effective: joint article selection one week before event, dissemination to audience, set time and location during departmental teaching, chairing by an academic consultant with information scientist and senior surgeons present, presentation led by a surgical trainee, open-floor discussion of article and its implications for our own practice, summary, drafting of letter to the editor if appropriate. as we have used variations of this model successfully at two independent nhs trusts, we believe that these tactics can be readily adapted and deployed by others as well. nil. dear sir, surgical ablation of advanced scalp malignancies requires wide local excision of the lesion, including segmental craniectomies. the free latissimus dorsi (ld) flap is a popular choice for scalp reconstruction due to its potential for mass surface area resurfacing, ability to conform to the natural convexity of the scalp, reliable vascularity and reasonable pedicle length. one of the disadvantages of ld free flap use is the perceived need for harvest in in a lateral position. this necessitates a change in position of the patient intraoperatively for flap raise and can add to the overall operative time. current literature in microvascular procedures on the elderly demonstrates that a longer operative time is the only predictive factor associated with an increased frequency of post-operative medical and surgical morbidity. as most patients undergoing scalp malignancy resection are elderly it is important to reduce this surgical time in this cohort of patients. , we present our experience of reconstruction of composite cranial defects with ld flaps using a synchronous tumour resection and flap harvest with supine approach to reduce operative times and potential morbidity. all patients undergoing segmental craniectomies with prosthetic replacement and ld reconstruction under the care of the senior surgeons were included in the study. patients were positioned supine with a head ring to support the neck; a sandbag is placed between the scapulae and the arm on the chosen side of flap raise is free draped. a curvilinear incision is made posterior to the midaxillary line ( figure ). the lateral border of the ld muscle is identified, and dissection continued in a subcutaneous plane inferiorly, superiorly and medially until the midline is approached. the muscle is divided at the inferior and medial borders, and the flap lifted towards the pedicle. once the pedicle is identified, the assistant can manipulate the position of the free draped arm to aid access into the axilla; the pedicle is clipped once adequate length has been obtained. the flap is delivered through the wound and detached ( figure ). donor site closure is carried out conventionally.the flap inset is performed using a "vest over pants" technique utilising scalp over muscle by undermining the remaining scalp edges. a non-meshed skin graft is used to enhance aesthetic outcome. a total of patients underwent free ld muscle flaps. all were muscle flaps combined with split-thickness skin grafts. the study population included ten male patients and one female. the age range was - years with a mean age of . years. the defect area ranged from cm - cm . a titanium mesh was utilised for dural cover in all patients fixed with self-drilling × . mm cortical screws. the primary recipient vessel used was the superficial temporal artery and vein. however, in cases where a simultaneous neck dissection and parotidectomy are necessary for regional disease, the facial artery and vein are used ( n = in this series) or contralateral superficial temporal vessels. the ischaemia time ranged from - min, with a mean of . min. there were no take backs for flap re-exploration. the overall flap success rate was %. marginal flap necrosis with secondary infection occurred in one patient with a massive defect (at one week post-op). the area was debrided and a second ld flap was used to cover the resultant defect ( %). a further posterior transposition flap was used to cover a minor area of exposed mesh. the scalp healed completely. the total operating time ranged between - min, with a mean of min. all patients were followed up at and then four weeks for wound checks. the ld flap remains a popular choice due to its superior size and ability to conform to the natural convexity of the scalp compared with other flap choices. also, unlike composite flaps which often require postoperative debulking procedures, the ld muscle flap atrophy's and contours favourably to the skull. however, the traditional means of access to this flap requires lateral decubitus positioning of the patient, which can hinder simultaneous oncological resection. the supine position facilitates access for neck dissection, especially if bilateral access is required. our approach ensures that the tumour ablation and reconstruction is carried out in a time efficient manner in an attempt to reduce postoperative medical and surgical complications. synchronous ablation and reconstruction are key in reducing overall operative time and complication risk and is practised preferentially at our institute. it is important to maintain a degree of flexibility to achieve this -there may be situation where supine positioning overall is more favourable. likewise, there are situations relating to flap topography where a lateral approach to tumour removal and reconstruction is preferred. the resecting surgeon or reconstructive surgeon may have to compromise to achieve synchronous operating but is worthwhile to reduce overall total operative time. none. not required. once established, lymphorrhea typically persists and can present as an external lymphatic fistula. lymphorrhea occurs in limbs with severe lymphedema, as a complication after lymphatic damage, and in obese patients. some cases are refractory to conservative treatment and require surgical intervention. reconstruction of a lymphatic drainage table three patients had primary lymphedema, had age-related lymphedema, had obesity-related lymphedema, and had iatrogenic lymphorrhea. in the cases of iatrogenic lymphorrhea, the lesions were located in the groin and the others in the lower leg. abbreviations: bmi, body mass index; f, female; m, male. three patients had primary lymphedema, four had agerelated lymphedema (aging of the lymphatic system and function is thought to be the cause of age-related lymphedema .), three had obesity-related lymphedema, and two had iatrogenic lymphorrhea ( table ) . one of cases of lymphorrhea in the inguinal region was caused by lymph node biopsy and the other by revascularization after resection of malignant soft tissue sarcoma. compression therapy had been performed preoperatively in cases (using cotton elastic bandages in cases). four patients wore a jobst r compression garment. compression therapy was difficult to apply in patients. the duration of lymphorrhea ranged from to months. the severity of lymphedema ranged from campisi stage to ( table ). the clinical diagnosis of lymphorrhea was confirmed by observation of fluorescent discharge from the wound on lymphography. no signs of venous insufficiency or hypertension were observed in the subcutaneous vein intraoperatively. all anastomoses were performed between distal lymphatics and proximal veins. postoperatively, lymph was observed to be flowing from the lymphatic vessels to the veins. two to lvas were performed in the region distal to the lymphorrhea and - in the region proximal to the lymphorrhea in patients with lower limb involvement. six lvas were performed in patients with lymphorrhea in the inguinal region ( table ) . all patients were successfully treated with lvas without perioperative complications. the volume of lymphorrhea decreased within days following the lva surgery in all cases and had resolved by weeks postoperatively. the compression therapy used preoperatively was continued postoperatively. there has been no recurrence of lymphorrhea or cellulitis since the lvas were performed. an -year-old woman had gradually developed edema in her lower limbs over a period of - years. she had also developed erosions on both lower legs ( figure ). compression with cotton bandages failed to terminate the percutaneous discharge; about ml of lymphatic discharge through the erosion was noted each day. ultrasonography did not suggest a venous ulcer resulting from venous thrombosis, varix, or reflux. four lvas were performed in each leg ( distal and proximal to the leak). the lymphorrhea had mostly resolved by days postoperatively. the erosions healed within weeks of the surgery. no recurrence of lymphorrhea was noted during months of follow-up. iatrogenic lymphorrhea occurs after surgical intervention involving the lymphatic system. it is also known to occur in patients with severe lymphedema. obesity and advancing age are also risk factors for lymphedema. most patients with lymphorrhea respond to conservative measures but some require surgical treatment. patients with lymphorrhea are at increased risk of lymphedema. lymphorrhea that occurs after surgery or trauma is caused by damage to lymphatic vessels that are large enough to cause lymphorrhea. lymphorrhea that occurs in association with lipedema or age-related lymphedema indicates accumulation of lymph that has progressed to lymphorrhea. it is possible to treat lymphorrhea by other methods, including macroscopic ligation, compression, or negative pressure wound therapy . however, it is impossible to reconstruct a lymphatic drainage route using these procedures. we hypothesized that lymphorrhea can be managed by using lva to treat the lymphedema. lva is a microsurgical technique whereby an operating microscope is used to perform microscopic anastomoses between lymphatic vessels and veins to re-establish a lymph drainage route. the primary benefits of lva are that it is minimally invasive, can be performed under local anesthesia, and through incisions measuring - cm. one anastomosis is adequate to treat lymphorrhea and serves to divert the flow of the lymphorrhea-causing lymph to the venous circulation. if operative circumstances allow, or more anastomoses are recommended for the treatment of lymphorrhea complicated by lymphedema. lymphedema is a cause of delayed wound healing, and lva procedures are considered to improve wound healing in lymphedema via pathophysiologic and immunologic mechanisms . lva is a promising treatment for lymphorrhea because it can treat both lymphorrhea and lymphedema simultaneously. the focus when treating lymphedema has now shifted to risk reduction and prevention, so it is important to consider the risk of lymphedema when treating lymphorrhea. none over-meshing : meshed skin graft we were curious to learn if it's feasible to mesh already meshed skin grafts. we run our skin bank at the department of plastic surgery and used allograft skin that was tested microbiologically positive and thus not suitable for patient use. grafts were cut into cm x . cm pieces and meshed using mesh carriers to : and over-meshed with : . . we used two kind of mesh carriers for : . meshes. the meshed grafts were maximally expanded and measured again. the results were expressed as ratios, figure . we found that, over-meshing results in . -fold increase in graft area regardless of the mesh carrier used. figure illustrates close-up picture of the over-meshed graft. in the close-up picture the small : incisions are still visible. in those undesirable "oh no the graft is too small"or "the graft is too large" -situations this technique has its advantages. we have used over-meshed graft in a skin graft harvest site, supplemental figure, with acceptable outcome. it seems that the tiny extra incisions in the overmeshed skin graft do not deteriorate the aesthetic outcome from the : . mesh. what is the clinical value of the tiny incisions, we don't know, but we approximate it to be minimal if even that. to best of our knowledge, only one previous publication has addressed the over-meshing of skin grafts . henderson et al. showed in porcine split thickness skin grafts that overmeshing resulted in increase of . ratio, a bit larger compared to our results. taken together, the results point to the direction that meshing of already meshed graft is feasible and does not destroy the architecture of the original or succeeding mesh. each author declares no financial conflicts of interest with regard to the data presented in this manuscript. supplementary material associated with this article can be found, in the online version, at doi: . /j.bjps. . . . numerous autologous techniques for gluteal augmentation flaps have been described. in the well-known currently employed technique for gluteal augmentation, it is noticeable that added volume is unevenly distributed in the buttock. in fact, after a morphological analysis, it becomes clear that the volume is added to the upper buttock to the expense of the lower buttock. according to wong's ideal buttock criteria, the most prominent posterior portion is fixed at the midpoint on the side view. additionally, mendieta et al. suggest that the ideal buttock needs equal volume in the four quadrants and its point of maximum projection should be at the level of the pubic bone. we describe a technique of autologous gluteal augmentation using a para-sacral artery perforator propeller flap (psap). this new technique can fill up all the quadrants vertically with a voluminous flap shaped like a gluteal anatomic implant. gluteal examination is done in a standing and prone position. patients must have a body mass index less than kg/m , an indication for a body lift contouring surgery, gluteal ptosis with platypygia and substantial steatomery on the lower back. when the pinch test is greater than cm this is defined as substantial steatomery. preoperative markings: the ten steps a. standing position . limits of the trunk. the median limit (mlt) and the vertical lateral limit (llt) of the trunk are marked. . limits of the buttock. the inferior gluteal fold (igf) is drawn. the vertical lateral limit of the buttock (llb) is defined at the outer third between the mlt and the llt. . lateral key points. points c and c' are located on the vertical lateral limits: point c is to cm below the iliac crest, depending on the type of underwear. point c' is determined by an inferior strong tension pinch test performed from point c. mhz. this diagnostic tool is easy to access, non-invasive, and above all, reliable in the identification of perforating arteries, with sensitivity and a positive predictive value of almost %. usually, one to three perforators are identified on each side and marked. . design of the gluteal pocket. the shape is oval, with the dimensions similar to those of the flaps. the base is truncated and suspended from the lower resection line. the width of the pocket is one to two centimeters from the lmt laterally and two centimetres from llt medially. the inferior border of the pocket is not more than two fingers'-breadth above the ifg. therefore, the pocket lies medial in the gluteal region. . design of the flap. the flap is shaped like a "butterfly wing" with the long axis following a horizontal line. after a °medial rotation, the flap has a shape similar to an anatomical gluteal prosthesis. the medial boundary is two fingers'-breadth from the median limit of the buttock, and the width is defined by the two resection limits. the patient is placed in a prone position, arm in abduction. the flap is harvested from lateral to medial direction, first in a supra-fascial plane then sub-fascial when approaching the llb. the dissection is completed when the rotation arc of the flap is free of restriction ( °− °), and viewing or dissection of the perforators is usually not required. to create the pocket, custom undermining is done in the sub-fascial plane according to the markings. the flap is then rotated and positioned into the pocket. the superficial fascial system is closed with vicryl (ethicon) and the deep and superficial dermis are closed with a buried intradermal suture and running subcutaneous suture with . monocryl (ethicon). a compressive garment (medical z lipo-panty elegance coolmax h model, ec/ -h) was worn postoperatively for one month ( figure ). rhinoplasty is one of the most common procedures in plastic surgery and - % of the patients undergo revision. dorsal asymmetry is the leading ( %) nasal flaw in secondary patients. careful management of the dorsum to achieve a smooth transition from radix to tip is necessary. camouflage techniques are well known maneuvers for correcting dorsal irregularities. cartilage, fascia, cranial bone, and acellular dermal matrix were previously used for this aim. , bone dust is an orthotopic option, which is easily moldable into a paste. it is especially useful in closed rhinoplasty, where our visual acuity on the dorsum is reduced. we introduce a new tool, a minimally invasive bone collector, as an effective and safe device for harvesting bone dust from the nasal bony pyramid to obtain camouflage on the dorsum and for performing ostectomy simultaneously. patients were operated for nasal deformity by the senior author (o.b.) with closed rhinoplasty between february and november . in all cases, a minimally invasive bone collector was used for ostectomy and the harvest of bone dust. included patients were primary cases with standardized photos, complete medical records, and -year follow-up. written informed consent for operation and publishing their photographs was obtained and the study was performed in accordance with standards of declaration of helsinki. the authors have no financial disclosure or conflict of interest to declare. patient data were obtained from rhinoplasty data sheets and photographs were used for the analysis of nasal dorsum height, symmetry, and contour. physical examinations were carried out for detecting irregularities. micross (geitslich pharma north america inc., princeton, new jersey) is a bone collector, which allows easy harvest, especially in narrow areas. micross comes with a package containing sterile disposable scraper. it is externally mm in diameter and has a cutting blade tip. a collection chamber allows harvesting maximum of . cc graft at once. a sharp technique improves graft viability. incisions for lateral osteotomies were used to introduce micross when the planned ostectomy site was nasomaxillary buttress. infracartilaginous incision was used when the desired ostectomy site was dorsal cap or radix. bone dust was collected into a chamber with a rasping movement. the graft is mixed with blood during the harvest, this obtains an easily moldable bone paste (surgical technique is described in the video). after the completion of osteotomies and cartilaginous vault closure, the bone paste was placed on the site of bony dorsum, which is likely to show irregularities postoperatively. a nasal splint was used to maintain contour. the bone graft was not wrapped into any other graft. eighteen patients underwent primary closed rhinoplasty with -year follow-up. seventeen of patients were female and one was male. harvesting sites were nasomaxillary buttress in patients, radix in patients and dorsal cap in patients. the total graft volume was between . and . cc/per patient. the nasal dorsum height, symmetry, contour, and dorsal esthetic lines were evaluated using standardized preoperative and postoperative photographs. dorsal asymmetry, overcorrection of the dorsal height or residual hump were not observed in of the patients ( figures - ). only patient had a visible irregularity of the dorsum. physical examination revealed palpable irregularities in patients. none of the patients required surgical revision for residual or iatrogenic dorsum deformity. asymmetries and irregularities of the upper one-third of the nose, lead to poor esthetic outcomes, and secondary revision surgeries. to treat open roof after hump resection; lateral osteotomies, spreader grafts, flaps and camouflage grafts are commonly used. warping, resorbtion and migration, visibility, limited volume, donor site morbidity, and the risk of infection are the main disadvantages of grafts. Örero glu et al. have presented their technique of using diced cartilage combined with bone dust and blood. tas have reported results with harvesting bone dust with a rasp and using this for dorsal camouflage. the disadvantages of harvesting with a rasp were difficulty with collecting dust from the teeth of the rasp and losing a certain amount of graft material during the harvest. with using micross, a harvested graft is collected in the chamber, thereby the risk of losing the graft material is resolved. replacing "like with like" tissue concept is important, therefore the reconstruction of a bone gap can be achieved successfully with bone grafts. to limit the donor site morbidity, we prefer to harvest bone from the dorsal cap, which was preoperatively planned to be resected. the preference of lateral osteotomy lines as the donor site facilitates osteotomies by thinning the bone. the device allows us to effectively harvest the bone under reduced surgical exposure. simultaneous harvest and ostectomy contributes to a reduced operative time. operative cost is relatively low in comparison with alloplastic materials. in this series, we did not experience resorbtion, migration, visibility problems, or infection with bone grafts. a new practical, safe, and efficient tool for rhinoplasty was introduced. graft material was successfully used for smoothing the bony dorsum without any significant complications. none. not required. the authors have no financial disclosure or conflict of interest to declare in relation to the content of this article. no funding was received for this article. the work is attributed to ozan bitik, m.d. (private practice of plastic, reconstructive and aesthetic surgery in ankara, turkey) dear sir, early diagnosis of wound infections is crucial as they have been shown to increase patient morbidity and mortality. hence, it is important that such infections are detected early to guide decision-making and management . currently, the most common methods of identifying wound infection is by clinical assessment and semi-quantitative analysis using wound swabs. bedside assessment is subjective, and it is shown that bacterial infection can often occur without any clinical features. on the other hand, swabs have the disadvantages of missing relevant bacterial infection at the periphery of the wound due to the sampling technique as well as delaying diagnostic confirmation which may lead to a change in the bioburden of the wound. although tissue biopsy is the gold standard diagnostic tool, it is seldom used as it is invasive, has a higher technical requirement and is also more expensive. a hand-held and portable point-of-care fluorescence imaging device (moleculight i:x imaging device, moleculight, toronto, canada) was introduced to address the limitations of the other diagnostic methods . this device takes advantage of the fluorescent properties of certain by-products of bacterial metabolism such as porphyrin and pyoverdine. when excited by violet light (wavelength nm), porphyrins will emit a red fluorescence whereas pyoverdine has a cyan/blue fluorescence. the types of bacteria that produce porphyrins include s. aureus, e. coli , coagulase-negative staphylococci, beta-hemolytic streptococci and others whereas pyoverdine which emits cyan fluorescence is specific to pseudomonas aeruginosa. this allows users to localise areas of bacterial colonisation at loads ≥ amongst healthy tissue which instead emits green fluorescence . the benefits of this device are that it is portable, non-contact which means minimising cross-contamination, non-invasive and it provides real-time localization of bacterial infection. all these features allow it to be a useful tool to aid diagnosis and guide further investigation and management. many previous studies that have examined the efficacy of auto fluorescent imaging in diagnosing infections in chronic wounds - . however, equally important is identifying infections in acute wounds which will help guide antimicrobial management as well as surgical debridement. often, broad-spectrum antibiotics are given where clinical assessment remains inconclusive. this, however, may lead to an increase in antimicrobial resistance. therefore, the use of moleculight i:x to identify infections in acute open wounds in hand trauma was evaluated. we collected data from patients who attended the hand trauma unit over a -week period prior to irrigation and/or debridement. wounds were inspected for clinical signs of infection and autofluorescence images were taken using the moleculight i:x device. wound swabs were taken, and the results of these interpreted according to the report by the microbiologist. autofluorescence images were interpreted by a clinician blinded to the microbiology results. patients were included, and data collected from wounds. wounds ( . %) showed positive clinical signs of infection, ( . %) were positive on autofluorescence imaging and ( . %) of wound swab samples were positive for significant infection. autofluorescence imaging correlated with clinical signs and wound swab results for wounds ( . %). in one case, the clinical assessment and autofluorescence imaging showed positive signs of infection but the wound swabs were negative. to the best of our knowledge, this is the first time the use of autofluorescence imaging in an acute scenario was investigated. in this study, out of of the wound swab samples that were positive, autofluorescence imaging correctly identified both ( %) ( fig. ) . one of the autofluorescence images which showed red fluorescence on the wound and which was clinically identified as infected showed growth of usual regional flora on microbiological studies. the reason behind this could be due to the method of sampling from the centre of the wound. on autofluorescence image, the areas of significant bacterial growth were on the edges of the wound ( fig. ) . this example illustrates the potential of using autofluorescence imaging to guide more accurate wound sampling. this has also been shown in a non-randomised clinical trial performed by ottolino-perry et al. . from a surgeon's perspective, autofluorescence imaging can guide surgical debridement by providing real-time information of the infected areas of the wound. furthermore, because of its portability, this device can also be used in intra-operative scenarios to provide evidence of sufficient debridement. although easy to use, the requirement for a dark environment causes a logistical problem. the manufacturers have realised that this is a limitation of the device and have created a single-use black polyethene drape called "darkdrape" which connects to the moleculight i:x using an adapter to provide optimal conditions for fluorescence imaging. while autofluorescence imaging can help clinicians to decide whether to start antibiotics or not, it does not provide any information on the sensitivities of the bacteria. another limitation with autofluorescence imaging we encountered in our study is the difficulty with imaging acute bleeding wounds where blood shows up as black on fluorescence and therefore may mask any underlying infection. in conclusion, autofluorescence imaging in acute open wounds may be useful to provide real-time confirmation of wound infection and therefore guide management. none declared. none received. supplementary material associated with this article can be found, in the online version, at doi: . /j.bjps. . . . when compared with the two previously published studies, publication rates have improved from and have not continued to decline. interestingly, the number of publications in jpras has fallen. this may be explained by a rise in the impact factor of the journal, increasing competitiveness for publications as well as an expansion in the number of surgical journals. we observed that journal impact factor for free paper publications was significantly greater and likely reflects the stringency of the bapras abstract vetting process. comparison with other specialties is inherently difficult, primarily due to differences in study design and inclusion criteria. exclusion of posters, inclusion of abstracts published prior to presentation and studies not referenced in pubmed affect the reported publication rates. a large meta-analysis, assessing publication of abstracts, reported rates of %. rates from other specialties are shown in figure . although our figures of close to % may seemingly rank low versus other specialties, including abstracts published prior to presentation would increase the publication rate to %, therefore making it more comparable. however, this would not be a direct comparison to the two previous bapras studies. one may debate that the academic value of a meeting should be judged upon its abstract publication ratio. however, the definition of a publication is itself clouded, with an increasing number of journals not referenced in the previous 'gold standard' of pubmed, including a number of open access journals. most would still argue the importance of stringent peer review as the hallmark of a valuable publication and perhaps this along with citability should remain the benchmark. in an age where publications are key components of national selection and indeed lifelong progression in many specialties, we must ensure that some element of quality control remains so as not to dilute production of meaningful data. we have been able to reassess the publication rates for the primary meeting of uk plastic surgery. the bapras meeting remains a high-quality conference providing a platform to access the latest advances in the field. significant differences in the methodology of available literature make other speciality comparisons challenging. however, when these are accounted for publication rates are similar. within a wider context, with the increase in open access journals, it has become ever more difficult to define a 'publication'. if publication rate is to be used as a surrogate for meeting quality, then only abstracts published after the date of meeting should be included. in order to continually assess the quality of papers presented at bapras meetings, the conversion to publication should be regularly re-audited. none. dear sir, global environmental impact and sustainability has been a heated topic in the recent years. plastics and singleuse items are widely, and perhaps unnecessary, used in the healthcare sector. various recent articles , discuss the negative impacts of this in the surgical world, but can we look at the nhs sustainability as a bigger picture? whilst it is a positive step to be considering how we can reduce the environmental impact of modern operating practice, it risks falling into the trap of being overly focused and not taking an holistic view of how the health service as a whole can become more environmentally focused and reduce costs. in fact, the operating theatre is one of the more difficult places to make change. single use medical devices seem like an obvious item to replace with a more environmentally friendly re-usable alterative, but what about patient safety? such a change would require the implementation of new workflows and supervision structures to make sure patient safety is maintained. these take time to create, will meet resistance in their design and implementation, and may not ultimately be adopted. in order to overcome these challenges, we must take a holistic view of the hospital environment -doing this reveals numerous opportunities for improvement with minimal impact on patient safety. the nhs incurs significant waste through using energy unnecessarily. some examples are readily visibly working in a hospital for a just few weeks: computers are left on standby through the night and at weekend; lights are left on throughout the night; and empty rooms are heated or cooled when left unoccupied. other sources of energy waste are less visible, but it is likely that some machinery (particularly air conditioning units) would show rapid return on investment through energy savings if they were replaced on a more regular basis. in the past, saving energy would have required a sustained campaign to educate staff and still be subject to the vagaries of human management (forgetting to switch the heating off on a friday night could lead to more than two days of wasted energy if not revisited until monday). today, solutions based on internet of things (iot) technology can use sensors to monitor the environment and take action to reduce consumption. with the use of ai and machine learning, these systems are becoming advanced such that they can even monitor and anticipate energy usage allowing rooms to be heated or cooled at times which mean that when staff arrive in the relevant room it is the ideal temperature. the nhs is starting to use such technology, with wigan hospital as the first example to install intelligent lighting. adoption should not be limited to lighting, however, and the nhs needs to adopt best practice from the commercial sector. for example, sensorflow based in singapore, provide an intelligent system that optimises cooling/heating costs for hotels around south east asia, saving the operators up to % in energy costs. , without doubt, these systems can also apply to hospital infrastructures and can help the nhs further reduce energy consumption. in addition to reducing energy consumption, the reduction of single use plastics has become a key focus in recent years and the nhs has started to address this issue. at least million single use plastic items were purchased by the nhs last year. the target to phase out plastic items used by retailers in the next months is laudable, however there is also a significant amount of disposable plastic items used in staff coffee rooms and hospital canteen. getting rid of such items completely and encourage staff to use reusable coffee cups and metal cutlery can potentially compound the cost-saving and environmental benefits. the nhs has established an early leadership position tackling environmental challenges -the first european intelligent lighting installation and ambitious targets to cut disposable plastic items -but more needs to be done. to maximise impact, the nhs needs to be seen as a whole (not by department) with the most senior executives in the health service driving national level change. we read with interest the recent article 'healthcare sustainability -the bigger picture'. the wider picture of the nhs environmental impact and sustainability clearly needs to be addressed. however, large-scale improvement projects to hospital buildings, such as intelligent lighting and heating systems, are likely to require huge investment in infrastructure and modernisation that the nhs in its current form is unfortunately unlikely to be able to make. we believe that the field of medical academia should similarly be contributing to environmental sustainability. firstly, the shelves of hospital libraries and offices internationally are lined with print copies of journals. we reviewed the surgical journals with the highest impact factors and found that all were still offering the option of a subscription of print copies, with of these printing monthly issues. consumers are able to access all journals electronically through institutional subscriptions or via the nhs openathens platform, which in our view is a more time-efficient way to search for articles, read them and to reference them. as such, we commend jpras for their recent move to online-only publication. additionally, with the increasing use of social media to discuss research and the creation of visual abstracts for articles to encourage readership, this will be likely to encourage this shift further. secondly, the environmental impact of the current academic conferencing culture must be addressed. by the end of training, a uk surgical trainee spends an average of £ attending academic conferences, but beyond this personal expenditure, what is the environmental cost? for each conference we attend, the printing of poster presentations, conference programmes and certificates all detrimentally impact our environment. furthermore, consider the conference sponsor bags we receive, filled with further printed material, plastic keyrings, stress-balls and disposable pens, all contributing to the build-up of plastic in our oceans. conferences, such as the british association of plastic and reconstructive surgeons scientific meeting, have now started using electronic poster submissions, with presentations being held consecutively on large television screens -but further measures are possible. a well-designed conference smartphone app forgoes the need for printed programmes and leaflet advertising from sponsors and could include measures to reduce the carbon footprint, such as promotion of ride-share options for venue travel. the concept of virtual conferences has also been explored. organisers of an international biology meeting recently asked psychologists to assess the success of a parallel virtual meeting, with satellite groups organising local social events afterwards. more than % of the delegates joined online and there was an overall % increase those attending the conference; a full analysis of the success of this approach to conferences is awaited. virtual conferences may enable delegates to sign in from multiple time zones and minimise travel, disruption of clinical commitments and time away from family. this option is being pursued by the reconstructive surgery trials network (rstn) in the uk, whereby the annual scientific meeting will be delivered using teleconferencing technology at four research active hubs across the uk, reducing delegate travel substantially and the conference's carbon footprint in turn. there is a clear but unmeasurable benefit of networking face-to-face for formation of personal connections, exchange of knowledge and opportunities for collaboration. the use of social media, instant messaging applications and modern teleconferencing technology are vital to retain this valuable aspect of academic conferencing. equally, perhaps there is a balance to be found, with societies currently holding biannual meetings moving to include one virtual, or running a parallel virtual event for those travelling long distances. the academic community must play a role in environmental sustainability by reducing the carbon footprint of our journals and conferences. jcrw is funded by the national institute for health and research (nihr) as an academic clinical fellow. none for completion of submission. none. we read with interest the study by sacher et al., who compare body mass index (bmi) and abdominal wall thickness (awt) with the diameter of the respective diea perforator and siea. they found that there was a significant ( p < . ) positive correlation between these variables, concluding that this association may mitigate for the increased perioperative risk seen in patients with high bmi. their findings disagree with a previous smaller study by scott et al. reconstruction in the high bmi patient group can be challenging, and is associated with higher complication rates. despite this, satisfaction with autologous reconstruction appears similar across bmi categories. as the authors discuss, perfusion, as a function of perforator diameter, is of key relevance to the safety of performing autologous breast reconstruction in patients with higher bmi. larger perforator sizes relative to total flap weight have been suggested to reduce the risk of post-operative flap skin or fat necrosis. while this is likely an oversimplification, as flap survival will also depend on multiple factors including perforator row compared to abdominal zones harvested, it does suggest that if the high bmi patient group has reliably larger perforators then their risk profile may be reduced. however, we suggest caution regarding reliance on the correlation they found between bmi or awt and perforator size when planning free tissue transfer. while they demonstrate p values suggesting correlation between bmi or awt and perforator diameter, the r (correlation coefficient) values that they determined through pearson correlation analysis are low, ranging from . to . . the resulting r (coefficient of determination) values are therefore in the range . - . , suggesting that only . - % of the variation in perforator diameter can be related to bmi or awt. it is therefore likely that other variables, such as height and historical abdominal wall thickness, that were not accounted for in the correlation analysis also play roles in determining perforator size, in addition to anatomical variation. in addition, their analysis and results depend on a linear relationship between the variables, which may not be the case. therefore although the authors demonstrate a correlation between abdominal wall thickness and perforator size, there is substantial variation between individual patients and so this relationship cannot be relied upon when planning autologous reconstruction. we read with interest pescarini's et al. article entitled 'the diagnostic effectiveness of dermoscopy performed by plastic surgery registrars trained in melanoma diagnosis'. the article is of great interest in highlighting the potential of plastic surgery registrar training in domains such as dermoscopy, especially for those trainees looking to specialise in skin cancer. training in these experiential skill domains is essential to building a diagnostic framework, and the comparable accuracy in diagnosis to dermatologists reflects this. it would be of great benefit to understand further how diagnostic accuracy evolves along the inevitable learning curve experienced using the dermoscope. pescarini et al. comment briefly on method of training but we believe the timeline is key, as is mentorship and regular appraisal. terushkin et al. found that for the first year of dermoscopy training benign to malignant ratios in fact increased in trainee dermatologists before going on to decrease potentially secondary to picking up more anomalies but not yet having the skill set to determine if these are benign or not. there is no reason to suggest that plastic surgery trainees' learning curves should differ significantly. this of course would skew the data presented in terms of accuracy at the end of the three year study period. more helpful would be a demonstration of how accuracy changes with time and experience, as one would expect, and of course how these rates are comparable to those of dermatologists. this would have implications for training programmes where specific numbers of skin lesions or defined timeframes for skin exposure during training are set as benchmarks for qualification. this is particularly pertinent for uk trainees; the nice guidelines for melanoma state that dermoscopy should be undertaken for pigmented lesions by 'healthcare professionals trained in this technique'. to understand the number of lesions that trainee plastic surgeons have to assess with a dermatosope before their diagnostic accuracy improves -or the time needed to achieve that accuracymight be a key factor for placement duration and numbers required for trainees to become consciously competent dermoscopic practitioners. reproducible training programmes in this regard are therefore vital. it must be pointed out that the role of the dermascope for plastic surgeons is likely to be narrower than for our dermatological colleagues. within the uk, the role of the plastic surgeon is primarily reconstructive, with some subspeciality involvement in diagnosis of melanomas and a range of non-melanomatous skin cancers and skin lesions. the dermoscope is primarily a weapon in the diagnosis of insitu or early melanoma for plastic surgeons where diagnostic certainty is unclear following a referral for consideration for surgical removal. where doubt remains over a naevus, surgical excision is still the normal safe default. dermatologists use dermoscopes for a broad range of diagnostic purposes on a wide variety of skin conditions. the familiarity and expertise with this instrument that they garner is therefore not surprising. we must be clear in resource-limited healthcare systems about what our specific roles are as plastic surgeons and how the burden of patient assessment is shared to appropriately deploy our skills within the context of a broader multidisciplinary framework. accuracy with the dermoscope is essential to safely treating patients in a binary fashion -should the lesion be removed or monitored? comparison with dermatological expertise is helpful as a guide and dermoscopy has an important diagnostic role for plastic surgeons, but we should not strive to be equivalent in skills to dermatologists with dermascopes at the expense of the development of vital surgical reconstructive skills and excellence throughout plastic surgery training. response to the comment made on the article "the diagnostic effectiveness of dermoscopy performed by plastic surgery registrars trained in melanoma diagnosis" we strongly agree with the benefit correlated to understand the learning curve experienced by plastic surgery registrars using the dermoscope. as stated in our article, the limit of our study is its retrospective nature. moreover, the training and the level of competence differed between the three registrars. at the beginning of the data collection, two of them were at their third year of specialist training and were using dermoscope since at least one year while the other one was at his first year. all the registrars attended specific but different dermoscopy courses and all of them completed a h on site training with a competent consultant. for this reason, the expertise partially differed among the three registrars. nevertheless, we believe a years' period should be long enough to truly homogeneously estimate the accuracy in diagnosis of melanoma by them. in fact, townley et al. demonstrate the attendance of the first international dermoscopy for plastic surgeons, oxford, improved the accuracy of diagnosing malignant skin lesions by dermoscopy rather than using naked eye examination. we believe a well-planned prospective study should be of great benefit in term of planning a reproducible dermoscopy plastic surgery-oriented training program. this could help to estimate when a clinician can be considered as competent dermoscopic practitioner. it should be underlined as learning how to use dermoscope is something is not possible to do from time to time but it need effort and self-study. we believed is important to properly plan a formal training in dermoscopy for all the plastic surgery registrars who will use this tool in their practice. vahedi et al. stated, as per their survey, only one of % of the plastic surgery trainees that used dermoscope in their practice had formal training. as all trainees perform outpatient appointments dealing with skin lesions, especially for trainees looking to specialize in skin cancer, we believed the expertise gained through specific course and training is not at expense of the development of surgical reconstructive skills, but instead it can lead improvement in performing outpatient appointment. proper use of dermoscope will make the skin cancer specialized plastic surgeon more confident and truthful if not in detecting melanoma at least in leaving evident benign lesions. keeping always in mind a multidisciplinary approach and a close cooperation between dermatologists and plastic surgeon is of paramount importance in skin cancer treatment. there is no conflict of interest for all of the authors. dear sir, as the author mentioned in this publication, the correction of infra-orbital groove by microfat injection did increase the postoperative satisfaction of lower blepharoplasty surgery . in this study, we want to explore whether this procedure can replace the previous fat pad transposition. months after the microfat injection, we have observed that fat continues to be present but its volume gradually disappears, and, with some, it totally vanishes. with fat pad transposition, the fat volume does not decrease, it seems that both have their advantages and disadvantages because the volume of transplanted fat after lower blepharoplasty might disappear gradually by time. survival of transposed fat through fat pad transposition is the best, creating a more natural look at the tear trough. however, the volume of augmentation might not be enough. it would be exceptional if we could combine both advantages; that is, to administer microfat injection after fat transposition. but prior to that, we would like to share the experience of the author. the fat pad is usually transposed to periosteum by two limits: one is the transposition of the medial fat pad to the inner groove and the other one is the transposition of the central fat pad to the center of the infra-orbital groove. as mentioned by the author, we fill the superficial layer (under the skin) and the periosteum layer (deep layer). injection into the deeper layer is not performed after lower blepharoplasty but before the musculocutaneous flap was closed. after fat pad transposition is completed, we would first cover up the musculocutaneous flap before asking the patient to sit up. then, the surgeon assesses whether a further filling of the groove with the fat is needed or not. if necessary, the musculocutaneous flap is opened and more fat is injected in-between the fat pads into the groove, but, definitely, not into the fat pads. the reason why we do the injection before the flap is closed is to accurately perform the insertion and to avoid entering into the intra-orbital fat pad, which may worsen the presence of eye bags. we inject the superficial fat only after the flap wound is closed. this procedure modifies the groove under the eye more accurately. we share with you our surgical methods with the hope that fat utilization and fat pad transposition will greatly improve surgical satisfaction. dear sir, eiben and gilbert are thanked for their comments. they may be correct in the original description of the respective flaps, but the five-flap z-plasty in our experience has always been known colloquially as the jumping man flap. indeed, extra caution is required in burns secondary reconstruction. the skin of these patients is typically thin, often scarred and unforgiving. flaps should never be undermined unless in an area of completely virgin tissue. the modification we presented does result in an apparently thinner base for the 'arm limb' flaps, but traditionally wider based flaps would have been transferred and then trimmed with the same outcome. the tiny sizes involved in paediatric eyelid surgery would not be the best forum to experiment, and certainly mustardé's original design would seem safest in that setting. we had uniquely sought to also measure precisely the geometric gain in length, and felt that the result was impressive. none letter to the editor: evaluating the effectiveness of plastic surgery simulation training for undergraduate medical students we read with interest the recent correspondence regarding the effectiveness of plastic surgery simulation for training undergraduate medical students. we are in wholehearted agreement with the statement regarding medical school curricula lacking exposure to plastic surgery and commend the authors for their efforts to pique the interest of medical students in our specialty. we wish however to point out some vagueness that, unless clarified, could be misleading to your readership. the correspondence states: "the decrease in competition ratios for plastic surgery". we believe that current data supports the opposite view. taking into account published data from health education england over the last years , there has in fact been a % rise in the competition ratios from to ( fig. .) suggesting an increasing interest in the specialty. highlighting this increase in demand supports the authors' desire for more undergraduate exposure to plastic surgery. this increased input in the uk curriculum would also help all medical students become aware of the support plastic surgeons can provide to other specialties as this is a particular feature of the specialty. in an increasingly specialised medical world, we feel it is important that all doctors are equipped with the knowledge to best serve their patients. no funding has been received for this work and the authors have no competing interest. dear sir/madam, in response to critical personal protective equipment (ppe) shortages during the covid- pandemic, medsupply-driveuk was established by ent trainee ms. jasmine ho, and medsupplydriveuk scotland by two plastic surgery trainees (ms. gillian higgins and mrs. eleanor robertson). we applied the principles of creative problem solving and multidisciplinary collaboration instilled by our specialty. since march , we have recruited over volunteers to mobilise over , pieces of high quality ppe donated from industry to the nhs and social care. we have partnered with academics and leaders of industry to manufacture: surgical gowns, scrubs and visors using techniques including laser cutting, injection molding, and d printing. we have engaged with nhs boards and trusts and politicians at local, regional and national level to advocate for healthcare worker protection in accordance with health and safety executive and coshh legislation including: engineering controls and ppe that is adequate for the hazard and suitable for task, user and environment. public health england (phe) currently advise ffp level of protection only in the context of a list of aerosol gener-the authors have no competing interests. ating procedures . a surgical mask confers x ( %) protection, ffp /n x ( - %) and ffp - , x ( > %) protection ( figure ). as sars-cov- is a novel pathogen, evidence is naïve and evolving, and since transmission occurs via aerosol, droplets and fomites from the aerodigestive tract, all uk surgical associations have issued guidance to use higher levels of ppe for procedures that are not included in the phe list ( ) . cbs, entuk and baoms have issued statements supporting the use of reusable respirators and power air-purifying respirators, and their use is approved by phe, health protection scotland, public health agency, public health wales, nhs and the academy of medical royal collages . the first author has experienced the need to quote bapras guidance in defense of their use of ppe . medsupplydrive (uk and scotland) hope to empower all healthcare workers to demand provision of adequate (i.e. will protect from sars-cov- ) and suitable (for the task, user and environment) ppe by engaging with their employers directly or through unions, royal colleges and associations. as a nation we must learn from other countries who successfully protected their workforce. data suggests that staff death is avoidable with the use of occupational health measures and ffp grade ppe , despite which at least uk health care workers have died of covid- . the strain placed on systems by sars-cov- , with reduced access to operating theatres, beds, equipment and staff has the potential for serious detrimental consequences for surgical training . ppe shortages and the subsequent necessity for rationing is causing additional harm. due to global demand and supply chain failures, ffp disposable masks for people with small faces are in particularly short supply. the majority of these individuals are female, and they are currently provided with no solution apart from avoiding "high risk" operating if/when this resource runs out; further depriving them of training opportunities. reusable respirators provide superior respiratory protection over disposable ffp masks due to design characteristics. they are more likely to provide reliable fit due to increased seal surface area (half face mm, full face mm). as they are designed to be decontaminated between patients and after each shift they are both economically and ecologically advantageous whilst also reducing fit testing burden and negating reliance upon precarious supply chains. there are factories in the uk which already make reusable respirators and medsupplydrive have been contacted by uk manufacturers looking to retool to meet this demand. although some nhs trusts remain reluctant to use reusable respirators, others have already adopted them routinely, using manufacturer decontamination and filter change advice. one nhs trust has supplied every member of their workforce with a reusable respirator as a sustainable plan for ongoing pandemic waves. it is apparent that healthcare workers are unable to access sufficient quantities of high quality respiratory protection. reusable respirators provide adequate protection from sars-cov- as well as being eminently suitable for a wide range of users, tasks and environment. we call on those reviewing decontamination and filter policy for reusable respirators to appreciate the urgency of the situation and expedite the process to enable all health and social care workers to access the respiratory protection that they need. at the epicenter of the covid- pandemic and humanitarian crises in italy: changing perspectives on preparation and mitigation love in the time of corona references . world health organization world health organization. who director-general's opening remarks at the mission briefing on 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url: available at url: https: //en.wikipedia.org/wiki/seminar (accessed internet resource: the telegraph. the inflexibility of our lumbering nhs is why the country has had to shut down internet resource: the british society for surgery of the hand. covid- resources for members caring for patients with cancer in the covid- era maxillofacial trauma management during covid- : multidisciplinary recommendations asps statement on breast reconstruction in the face of covid- pandemic statement from the association of breast surgery th march : confidential advice for health professionals blazeby jmbreast reconstruction research collaborative. short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (ibra): a multicentre, prospective cohort study how the wide awake tourniquet-free approach is changing hand surgery in most countries of the world. hand clin hand trauma service: efficiency and quality improvement at the royal free nhs 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( ) th march highlights for surgeons from phe covid- ipc guidance american society of plastic surgery website. asps guidance regarding elective and non-essential patient care the effect of economic downturn on the volume of surgical procedures: a systematic review an analysis of leading, lagging, and coincident economic indicators in the united states and its relationship to the volume of plastic surgery procedures performed telemedicine in the era of the covid- pandemic: implications in facial plastic surgery united states chamber of commerce website. resources to help your small business survive the coronavirus transmission of covid- to health care personnel during exposures to a hospitalized patient early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia otorhinolaryngologists and coronavirus disease (covid- ) quantifying the risk of respiratory infection in healthcare workers performing high-risk procedures skills fade: a review of the evidence that clinical and professional skills fade during time out of practice, and of how skills fade may be measured or remediated ad hoc committee on health literacy for the council on scientific affairs training strategies for attaining transfer of problemsolving skill in statistics: a cognitive-load approach use of a virtual d anterolateral thigh model in medical education: augmentation and not replacement of traditional teaching? augmenting the learning experience in primary and secondary school education: a systematic review of recent trends in augmented reality game-based learning aging and wound healing tissue engineering and regenerative repair in wound healing duration of surgery and patient age affect wound healing in children investigating histological aspects of scars in children formation of hypertrophic scars: evolution and susceptibility early laser intervention to reduce scar formation in wound healing by primary intention: a systematic review early laser intervention to reduce scar formation -a systematic review effectiveness of early laser treatment in surgical scar minimization: a systematic review and meta-analysis cochrane handbook for systematic reviews of interventions version prospective or retrospective: what's in a name? how to run an effective journal club: a systematic review the evolution of the journal club: from osler to twitter free flap options for reconstruction of complicated scalp and calvarial defects: report of a series of cases and literature review the effect of age on microsurgical free flap outcomes: an analysis of , cases factors affecting outcome in free-tissue transfer in the elderly reconstruction of postinfected scalp defects using latissimus dorsi perforator and myocutaneous free flaps long-term superiority of composite versus muscle-only free flaps for skull coverage indocyanine green lymphography findings in older patients with lower limb lymphedema microsurgical technique for lymphedema treatment: derivative lymphatic-venous microsurgery lower-extremity lymphedema and elevated body-mass index lymphorrhea responds to negative pressure wound therapy lymphovenous anastomosis aids wound healing in lymphedema: relationship between lymphedema and delayed wound healing from a view of immune mechanisms evolving practice of the helsinki skin bank skin graft meshing, overmeshing and cross-meshing gluteal implants versus autologous flaps in patientswith postbariatric surgery weight loss: a prospective comparative of -dimensional gluteal projection after lower body lift redefining the ideal buttocks: a population analysis classification system for gluteal evaluation blondeel and others. doppler flowmetry in the planning of perforator flaps frequency of the preoperative flaws and commonly required maneuvers to correct them: a guide to reducing the revision rhinoplasty rate temporalis fascia grafts in open secondary rhinoplasty the turkish delight: a pliable graft for rhinoplasty bone dust and diced cartilage combined with blood glue: a practical technique for dorsum enhancement the use of bone dust to correct the open roof deformity in rhinoplasty wound microbiology and associated approaches to wound management moleculight _ ix _ user _ manual _ rev _ . _ english the use of the moleculight i:x in managing burns: a pilot study improved detection of clinically relevant wound bacteria using autofluorescence image-guided sampling in diabetic foot ulcers efficacy of an imaging device at identifying the presence of bacteria in wounds at a plastic surgery outpatients clinic publication rates for abstracts presented at the british association of plastic surgeons meetings: how do we compare with other specialties? are we still publishing our presented abstracts from the british association of plastic and reconstructive surgery (bapras)? full publication of results initially presented in abstracts the true cost of science publishing science for sale: the rise of predatory journals plastics in healthcare: time for a re-evaluation green theatre wigan's hospital organisation is first health trust in europe to install intelligent lighting sensorflow provides smart energy management for hotels in malaysia nhs bids to cut up to million plastic straws, cups and cutlery from hospitals healthcare sustainability -the bigger picture on behalf of the council of the association of surgeons in training cross-sectional study of the financial cost of training to the surgical trainee in the uk and ireland plastic waste inputs from land into the ocean low-carbon, virtual science conference tries to recreate social buzz body mass index and abdominal wall thickness correlate with perforator caliber in free abdominal tissue transfer for breast reconstruction patient body mass index and perforator quality in abdomen-based free-tissue transfer for breast reconstruction increasing body mass index increases complications but not failure rates in microvascular breast reconstruction: a retrospective cohort study are overweight and obese patients who receive autologous free-flap breast reconstruction satisfied with their postoperative outcome? a single-centre study predicting results of diep flap reconstruction: the flap viability index the diagnostic effectiveness of dermoscopy performed by pastic surgery registrars trained in melanoma diagnosis analysis of the benign to malignant ratio of lesions biopsied by a general dermatologist before and after the adoption of dermoscopy assessing suspected or diagnosed melanoma dermoscopy-time for plastic surgeons to embrace a new diagnostic tool? the use of dermatoscopy amongst plastic surgery trainees in the united kingdom modification of jumping man flap combined double z-plasty and v-y advancement for thumb web contracture plastic surgery in infancy evaluating the effectiveness of plastic surgery simulation training for undergraduate medical students united kingdom mr. b.s. dheansa queen victoria hospital recommended ppe for healthcare workers by secondary care inpatient clinical setting, nhs and independent sector personal protective equipment (ppe) for surgeons during covid- pandemic: a systematic review of availability, usage, and rationing covid- : protecting worker health. annals of work exposures and health memorial of health & social care workers taken by covid- nursing notes covid- robertson canniesburn plastic surgery and burns unit georope geo-technical and rope access solutions, west quarry none. the authors have no financial interests to declare in relation to the content of this article and have received no external support related to this article. no funding was received for this work. the authors would like to thank catriona graham, sarcoma specialist nurse who helped in the evaluation of this study. the authors kindly thank the beatson cancer charity, uk (grant application number - - ), the jean brown bequest fund, uk, and the canniesburn research trust, uk for funding this study. the sponsors had no influence on the design, collection, analysis, write up or submission of the research. supplementary material associated with this article can be found, in the online version, at doi: . /j.bjps. . . . none. the authors declare no funding. jeremy rodrigues provided data from the two nhs trust journal clubs and invaluable advice. nil. all authors declare that there were no funding sources for this study and they approved the final article. supplementary material associated with this article can be found, in the online version, at doi: . /j.bjps. . . . all authors disclose any commercial associations or financial disclosures. none. none. none. none. all authors agree to the fact there are no conflicts of interest to declare. no funding was provided for this letter. the authors have no financial or personal relationships with other people or organizations, which could inappropriately influence the work in this study. the authors have no financial disclosure or conflict of interest to declare in relation to the content of this article. no funding was received for this article. supplementary material associated with this article can be found, in the online version, at doi: . /j.bjps. . . . dear sir, long has the term 'publish or perish' been considered medical doctrine and this has historically been a prerequisite for progression in research-driven specialties such as plastic surgery. national, or indeed international, presentation is pivotal to disseminating information, but also provides a stepping-stone to future publications. in the uk, bapras meetings have always represented the ideal platform for this. of significant interest is the conversion of accepted abstracts into peer-reviewed publications.previous studies , have assessed abstract publication for bapras meetings and have shown a declining conversion rate. we re-assessed this in order to establish whether this reported downtrend is continuing and how plastic surgery compares to other specialties.all abstracts from bapras meetings between winter and summer were analysed. later meetings were excluded to allow adequate lag time for publication. abstracts were identified retrospectively from conference programmes accessible via the bapras website ( www.bapras. org.uk ). pubmed ( https://www.ncbi.nlm.nih.gov/pubmed/ ) and google scholar ( https://scholar.google.com/ ) databases were used to search for full publications. cross-referencing of published papers with abstracts for content was completed to ensure matched studies.abstracts published prior to the conference date were excluded. two-tailed t -testing was used to assess for statistical significance between variables. none. none. dear sir, diver and lewis described a modification of the "jumping man flap". in fact, what they have described is a modification of the -flap z-plasty. this was described by hirschowitz et al. it is not a jumping man as it has no body.the true jumping man flap was described by mustarde for the correction of epicanthal folds and telecanthus.we have used the -flap z-plasty particularly for the release of st web space contractures following burns, the modification of raised curved scars of the trunk and limbs following burns, and for the correction of epicanthal folds in small children.using the diver and lewis modification in burn cases results in thin and less vascular flaps. when correcting epicanthal folds in children the flaps are so small that reducing their size in any way would make it near impossible to suture the flaps correctly. no conflicts of interest. key: cord- -nc jhemz authors: murphy, thérèse; whitty, noel title: is human rights prepared? risk, rights and public health emergencies date: - - journal: med law rev doi: . /medlaw/fwp sha: doc_id: cord_uid: nc jhemz nan public health security is . . . the activities required, both proactive and reactive, to minimize vulnerability to acute public health events that endanger the collective health of national populations. global public health security widens this definition to include acute public health events that endanger the collective health of populations living across geographical regions and international boundaries . . . .[g]lobal health security, or lack of it, may also have an impact on economic or political stability, trade, tourism, access to goods and services and, if they occur repeatedly, on demographic stability. the other term that requires some explanation is 'public health emergency legal preparedness'. stated shortly, this is all about having the right laws in place and then using them in the right way in a time of public health emergency. in other words, it is about both legal preparedness for, and response to, public health emergencies -it is both proactive and reactive. more generally, it can be said to be an essential part of both public and global public health security, and a subset of public health emergency preparedness. having identified these basics, we move to the purpose of this article. the aim is to present a human rights lawyer's perspective on both public health emergency preparedness and, more generally, the turn towards securing public health through securitisation. we develop this perspective by asking the following question: is human rights prepared for public health emergency preparedness? we are not confident that it is. in what follows, we explain why we take this view and we also sketch out a preliminary agenda designed to encourage greater human rights preparedness. we focus in particular on the importance of thinking through how risk and its relationship to rights is being framed, and also how this relationship ought to be framed. one response to public health emergency preparedness might go as follows: even if there is an abundance of new terms, there is nothing new about the link between health and security. the detailed version ibid., at . medical law review [ ] of this response would run as follows: focusing first on national security, the effect of disease on military strength and preparedness is, without doubt, an age-old concern. infectious diseases can also be a source of indirect harm to national security given their potential to cause 'political and economic damage in countries in which a state has vital security, foreign policy, and trade interests'. turning next to economic security, it is clear that here too there is a longstanding link to health. the first international health regulations ( ) and their predecessors, the international sanitary regulations ( ) , were explicit about this link: they aimed to 'ensure the maximum security against the international spread of diseases with a minimum interference with world traffic'. finally, a third, more general, link between health and security arises from the fact that infectious diseases can 'erode governance capacities' and undermine 'a population's confidence and trust in the political leadership and system'. clearly, then, there are longstanding connections between health and security. but that does not mean that the contemporary linkage between health and security is nothing new. to explain why we think there is something new in play, and to provide background for our argument in the latter parts of the article, this section sketches a history of the relationship between security and health. in particular, drawing on recent developments in international law and policy, it aims to show that health has come to be 'looked at through a new lens'. we begin in , the year in which the united nations development programme (undp) called for attention to be directed towards the achievement of 'human security', 'an idea . . . likely to revolutionize society in the st century'. for undp, traditional concepts of security were, on the one hand, too focused on protecting states from 'external aggression, or as protection of national interests in foreign policy or as global security from the threat of nuclear holocaust' and, on the other, not focused enough on 'the legitimate concerns of ordinary people who sought security in their daily lives'. undp saw 'human security' as a way to address this imbalance. it argued that human security could help to protect people from both chronic threats (such as hunger) and sudden, harmful disruptions of their daily lives. six years later, in , another less-than-conventional definition of security emerged. this time it came from a more surprising source: the un security council, which held a session in january on peace, security and hiv/aids, focusing in particular on the impact of aids in africa. the security council's conjunction of peace, security and hiv/aids was novel. so too was its depiction of security and its explicit reference to the pioneering nature of its own position: it emphasised that by discussing hiv/aids as a security threat, it was 'exploring a brand-new definition of world security' and establishing 'a precedent for security council concern and action on a broader security agenda'. september (or / ) is the next crucial date in this short history. as lucia zedner has explained, '[t]he events of that day alter the landscape of security irrevocably'. very shortly thereafter, anthrax letters, sent using the us postal service, affected people, of whom five died. as a core component of its response to the events of , the united states committed to a range of legislative and regulatory activity designed to improve the preparedness of its public health law. for example, within weeks of september , the centers for disease control and prevention (cdc) had commissioned a draft model state emergency health powers act and, as of , the united states is scheduled to have its first national health security strategy, designed to augment the extant strategies covering, respectively, the national security of the united states and homeland security. strongly worded rhetoric on health and security has run alongside these reforms. typically, this rhetoric invokes the importance of experienced an outbreak of plague, causing reported deaths; and second, a cholera epidemic killed up to , of the approximately , refugees who had fled to the democratic republic of the congo to escape the crisis in rwanda: see, respectively, dt dennis, 'plague in india ' ( ) the united states is only one among numerous jurisdictions pursuing public health emergency preparedness. put bluntly, 'vulnerability is universal '. in , another global health security concern emerged: severe acute respiratory syndrome (sars), a new and serious infectious disease. sars began to spread internationally in february , approximately two months after the global outbreak alert and response network (goarn)-a multi-partner network of agencies and technical institutions established by who -had detected a confirmed influenza outbreak in the guangdong province of china. on march , who issued its first global alert about the new infectious disease. three days later, it issued a second alert, naming the disease, offering guidance to health professionals and public health authorities, and alerting international travellers to the spread of the disease. within four months, however, transmission of sars had been interrupted in all affected countries and, on july , who announced that the outbreak had been contained. in total, , cases of sars were recorded in countries, with documented deaths (hospital staff were most affected). there were also serious financial implications due to disruption of travel, tourism, trade and production; who's estimate is that the outbreak cost us $ . billion in the asian countries affected. the sars outbreak and its containment produced a range of responses. china, for example, was criticised for its delay in reporting cases and an initial lack of cooperation with who. who was criticised by canada for its unilateral issuance of travel advice to persons proposing to travel to toronto, the city outside asia worst affected by the outbreak. meanwhile, in canada, delays and wrangling between the ontario government and the federal government over funding to provide compensation for individuals may have undermined the quarantine scheme by leaving people with financial incentives to break quarantine. as part of quarantine and isolation measures, some jurisdictions, including canada, adopted policies involving heavy limitations on individual rights. who has said that these control schemes were responsible for the interruption of transmission of the disease within four months of the announcement of the outbreak, but the use of measures that severely restricted individual freedoms was deeply controversial. the year is, however, notable for more than the sars outbreak and its containment. it was also the year in which the commission on human security, co-chaired by sadako ogata and amartya sen, issued its final report. the commission labelled illness, disability and avoidable death as 'critical pervasive threats' to human security; more generally, it harnessed the language of security to highlight the ongoing neglect of social and economic rights. one year on, in , 'comprehensive collective security'-described as a 'new and broader understanding' of international security-provided the overall vision behind the report of the un secretary general's high-level panel on threats, challenges and change. the panel prescribed an improvement in public health systems, arguing that: ur best defence against this danger lies in strengthening public health' and he seemed to indicate that he supported an expanded role for the security council in the event of an 'overwhelming outbreak of infectious disease that threatens international peace and security'. a few months later, in may , the world health assembly, the highest decision-making body of who, adopted a revised set of international health regulations (ihr ( )). these regulations were welcomed by the then director general of who as a 'major step forward for international health'. they took effect in june , binding who member states on an opt-out basis. they contain articles, organised across ten parts, and a total of nine annexes, and, crucially, they are significantly different from their predecessors, the international health regulations ( ). the new regulations take what has been described as an '"all risks" approach', encompassing any emergency with repercussions for international health security, including ibid., at para . ibid., at para . ibid., at para xx. outbreaks of emerging and epidemic-prone diseases, outbreaks of food borne disease, natural disasters, and the accidental or deliberate release of pathogens, or chemical or radio-nuclear materials. their purpose is to: prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade. to give effect to this, they place obligations on member states with respect to surveillance and response capacities; states are also obliged to notify who of events within their territories that may constitute a 'public health emergency of international concern'. but what of human rights? do they feature in the new ihr? put shortly, the answer is yes. article ( ) contains the first reference to human rights: it states that the implementation of the ihr is to be 'with full respect for the dignity, human rights and fundamental freedoms of persons'. thereafter, human rights crop up in a number of articles. article , for example, provides that all health measures must be applied in a transparent and non-discriminatory way. informed consent and information privacy feature in several articles, including article which provides that states parties must not apply health measures such as vaccination, medical examination or isolation to international travellers without 'prior express informed consent', save in circumstances where there is 'evidence of an imminent public health risk'. article ( ) provides that states parties must treat personal health information in a confidential manner 'as required by national law'. more generally, the new ihr feature requirements concerning any limitations on rights that are familiar from international human rights law. so, for example, who recommendations to states parties, and health measures implemented by states parties in response to identifiable risks, must be 'no more invasive or intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health see article for definitions of the terms 'public health risk' and 'public health emergency of international concern'. article . article ( ), however, emphasises that states parties have 'the sovereign right to legislate and to implement legislation in pursuance of their health policies', noting that in so doing they should uphold the ihr. see, respectively, articles , and annex , and article and annex . if there is such evidence, then international travellers may be advised or compelled to submit to control measures such as vaccination, quarantine and isolation. protection'. the ihr also give who a new power to use information about disease outbreaks provided by unofficial sources (for example, non-governmental organisations or individual scientists). significantly, who has described this new power as a 'revolutionary departure from previous international conventions and regulations'. so, how should a human rights lawyer respond to the panoply of new linkages between health and security and, more specifically, the increasing focus on public health emergency preparedness? in this section of the article, we outline two possible responses. we use broad strokes, not close detail: the aim is to provide a sense of the most likely human rights responses and to flag up why, in our view, they point to a need for greater human rights preparedness. the first possible human rights response to public health emergency preparedness is to embrace it, even acclaim it. this response will see public health being brought 'in from the cold'-its profile raised and increased resources directed towards it-as a result of the new linkage between health and security. preparedness, it will suggest, is a 'win-win'. specifically, investment in countering biothreats offers not just the possibility of protection against bioterrorism, but also enhanced public health given that 'the more research in weaponized diseases that takes place, the more innovations for disease prevention will be found'. investment in hospitals, it will argue, should also receive a boost as a result of the new focus on preparedness: after all, 'if a bioweapon is released and people get sick, they will go to hospital first'. faced with historical evidence of abuse committed in the name of public health, and of a traditionally hands-off response by the judiciary when faced with challenges to public health measures, this first response is likely to counter-claim that human rights have been explicitly built-in as part of the ihr. it may also argue that states parties article ( ) re states parties; see also articles and . as regards who recommendations, see article . see articles , and . who is required to seek official verification from the state concerned before taking action. it can share the information with other states if the affected state does not cooperate with verification and control efforts, 'when justified by the magnitude of the public health risk'. above n , at xv. jackson, above n , at . ibid., at . this first response will probably also argue that the overall response to hiv/aids shows that the linkage between health and human rights is now both accepted and embedded as best practice. the ascent of human rights in the popular imagination and in national, and international, legal and political orders might also be invoked. and, linked to this, it is likely that emphasis will be placed not just on the emergence of a 'right to human security' but also the fact that, today, neither states nor private actors (such as pharmaceutical companies) can afford to ignore human rights. putting that another way, this first response will point out that, today, rights are a potential risk for states and private actors. we think that this first response will also make claims focused on 'what works'. two particular claims spring to mind. the first addresses international co-operation: it will counter the argument that state sovereignty is an insurmountable obstacle to co-operation with evidence from the sars outbreak in -in particular, who's unilateral issuance of a travel advisory and, relatedly, the fact that canada was 'a model of transparency in its reporting and public information, of determination in its contact tracing'. in short, and in the words of the then executive director of communicable diseases at who, the argument will be that: the outbreak of sars in and its successful global containment are testimony to a new way of working internationally for the public good. there is another possible version of the 'what works' argument, which focuses on drawing-out the rights potential of the language of security. it will run as follows: if, as seems to be the case in the counter-terrorism context, security and human rights are increasingly represented as in conflict, with rights struggling to maintain popular confidence, why not use security-specifically, a right to security-as a way to bolster human rights? this argument will then go on to emphasise that states' obligations vis-à -vis positive rights (that is, economic, social and cultural rights) could also be bolstered by emphasising the importance of human security. there is though a second, very different, human rights response to public health emergency preparedness and the wider securitisation of health. as we see it, its defining stance will range from anxiety to outright opposition, and it absolutely will not share the optimism of the first response. for instance, faced with the latter's claims on 'win-win', its position is likely to be that preparedness distorts public health priorities, with negative consequences everywhere, but especially in developing states. securitisation, it will argue, compromises the public's health as it clambers after public health as security. moreover, even if one accepts the skewing of attention towards preparedness, isn't it the case-it will argue-that the preparedness project is out of balance? why does investment in neglected diseases continue to lose out so heavily in terms of funding? and, if hospital 'surge capacity' is a core issue, why hasn't there been more investment in public hospitals? claims of a new, co-operative world order will also be met with incredulity. co-operation on preparedness is essential and is embedded in the ihr, but it is also incredibly fragile, as was made clear in - when indonesia temporarily stopped sharing samples of the human avian influenza virus with who. the cessation was prompted by the indonesian government's anger at what it saw as the commercial exploitation of developing countries. the catalyst for this was the announcement by an australian pharmaceutical company that it had developed a vaccine and could manufacture enough to protect the australian public within six months. the company was one of a number that had received indonesian samples from who. indonesia pulled out of sample-sharing with who, insisting that who change the rules to stop commercial abuse of poorer countries. it also allegedly entered into an arrangement with a us-based pharmaceutical company to provide samples in return for affordable access to any vaccine that might be developed. it is very likely that this second grouping of human rights advocateslet us call them linkage-sceptics-will also take a very different stance on the contemporary standing of human rights. it is true, the sceptics will agree, that human rights are built into the ihr. ultimately, however, article of the ihr reserves the sovereign right of states parties to legislate for the public good, upholding the purpose of the ihr and sound science. moreover, the human rights provisions in the ihr have 'little to say about protection of livelihoods and food security, or potential health impacts that might result from the distortion of public health priorities towards global surveillance'. the linkage-sceptic is also likely to point to a problem arising from a less obvious source: the health and human rights movement itself. this movement encompasses two different approaches to public health and human rights, one that forthrightly acknowledges the potential tension between public health necessity and human rights, and another that rejects the assumption of such a tension and instead sees the pursuit of public health and human rights as inextricably linked. one consequence of this has been vigorous intra-movement debate about the extent and inevitability of conflicts and trade-offs between public health and liberty. this debate is both inevitable and deeply useful, but there is a problem in that, in an 'age of preparedness', robust debate amongst rights advocates about the pros and cons of trade-offs could be read in a way that puts rights at risk. threats to human rights-and indeed, human rights as a threat-are nothing new. the hype, or 'myth', of rights is a claim that is familiar from empirical socio-legal work on rights. problems with rights have also been emphasised by rights-sceptics. the point though is that, lately, a new link between human rights and risk has emerged, largely as a result of post / rhetoric about life in a 'time of crisis'. its position, in crude terms, is that exceptional times mandate exceptional measures to deal with risk. as liora lazarus and benjamin goold have pointed out, 'the idea that certain human rights can be "turned off" when necessary' has acquired remarkable power; it is now widely regarded as a 'thoroughly reasonable reaction to the dangers allegedly faced by democratic societies'. and, as they go on to emphasise: the exceptionalism argument has become pivotal, so much so that liberals and human rights organisations must either rebut claims in this environment, human rights advocates debating the relationship between public health and human rights need to be extremely careful. the ascent of post / exceptionalism is also reason to be deeply wary of upbeat, optimistic assessments concerning the relationship between security and human rights. for the linkage-sceptic, the hope that has been invested in the idea of a 'right to security' is misplaced, not least because this right could take shape as an argument against human rights. think, for example, of the claim that human rights are no more than a tool used and abused by 'minorities', especially 'dangerous, violent minorities'. this tends to be accompanied by another claim: namely, it is the right to security of 'law-abiding, decent people' to live safe and secure from crime and violence that has been neglected and needs shoring up. moreover, these claims do not crop up only in the context of terrorism. as jonathan montgomery has pointed out, in the uk, discussions on the criminalisation of disease transmission have been fed by metaphors of disease carriers 'as markedly different from "normal" members of society', encouraging 'people to think of the transmission of disease as the province of evil criminals, not people like them'. specifically: those being prosecuted are [now] demonized less for their disease status than as sexual predators, and coverage shows a strong racial overtone. . . . aids is no longer presented as a gay plague but an african one. even more clearly the protection of victims from aggressors has emerged as the rationale for criminalization, obscuring public health issues. the innocence of the victims and the evil of the aggressor are stressed. in our view, the sceptic's argument makes a great deal of sense. put bluntly, amidst the new 'rights revolution', which is characterised by a ibid. med.l.rev. defensiveness in human rights advocacy and, its correlate, an anti-rights sentiment that queries the legitimacy of rights in a time of alleged crisis, there are no guarantees that the securitisation of public health, the right to security or human security will be good for human rights. moreover, we know from history that, in the past, terrible abuses have been committed in the name of public health. we have a potential problem, however, because in addition to agreeing with the sceptic's argument, we also agree with at least some of the optimist's argument. in particular, we cannot see how being 'against security' is a viable stance. in what follows, we try to address our split reaction by thinking through how human rights could engage more effectively with security. in this section, we focus on moving towards human rights preparedness in the 'age of preparedness'. in particular, we focus on risk, an increasingly common thread in contemporary debates about security. we ask: how does the identification and management of public health risks, tied explicitly in the ihr to the use of scientific principles and evidence, fit with human rights? we argue that, in order to answer this, human rights advocates need to direct greater critical attention towards prevailing interpretations of the relationship between risk and rights. we propose two frames of enquiry: first, risk within rights and, secondly, rights as risk. thinking through these frames is, we suggest, an essential foil to the now-conventional mode of thinking about risk and rights which fixates on risk versus rights. as its name suggests, the first frame-risk within rights-emphasises risk as a component of human rights law. it emphasises, in particular, that the prevention of (future) harm can be interpreted within the existing framework of human rights. risk-emerges from a now-dominant feature of contemporary governance: the assessment and management of risk. governments and organisations (whether national or international, and public, private or public-private in character) are expected to identify and prioritise the range of risks (financial, legal, political, reputational, regulatory, etc.) to which they are exposed. the particular point we want to draw out from this is that managing risk means managing the risk of rights. moreover, this risk is not limited to legal risk, that is, ( potential) claims and litigation for violation of human rights obligations. rather, because human rights are more than human rights law, rights as risk also encompasses the potential for human rights consciousness (as manifested, for example, in a public campaign) to disrupt the interests and overall standing of governments and organisations. a. risk within rights in many respects, 'risk' is not new ground for human rights lawyers. the terminology of risk was not widely used in the past, but analysing how threats to public health could be dealt with in a manner compatible with the normative frameworks of human rights instruments is an exercise that should be familiar to human rights lawyers. international instruments, including the european convention on human rights (echr) and the international covenant on civil and political rights (iccpr), enable states parties to derogate from certain human rights in the event of public emergencies that threaten 'the life of the nation'. at other times, limitations on non-absolute rights are permitted, provided certain conditions are met. for example, interference with article echr on the right to privacy is justified if it is legally prescribed, serves a legitimate purpose and can be proved to be 'necessary in a democratic society'. for the european court of human rights, the principle of proportionality is a key component of the latter 'democratic necessity' test. more broadly, although the intensity of review in individual contexts (for example, interference with the right to liberty or privacy), and the exact legal terminology and method used, will differ, common judicial approaches towards questions of justification must recognize that liberty is part of our communal interests, along with public health . . . .' as regards the iccpr, see also the siracusa principles on the limitation and derogation provisions in the iccpr. see, also, the 'intervention ladder' proposed by the nuffield council on bioethics in its recent report on public health, above n . or necessity can be found across jurisdictions. it is simply not correct therefore to claim that human rights law fails to deal with risk, or that a choice always has to be made between risk and rights. it is possible to identify-through the structure and interpretive principles of human rights instruments-the means to mediate the relationship between risk and rights. putting that another way, the framework of human rights law can, and already does, address issues of risk. until very recently, however, the identification of a 'risk within rights' approach did not register either among human rights lawyers or in the public imagination more generally. one explanation for this is that, for understandable reasons, lawyers did not pay much attention to the meaning, and role, of risk. it was not a focus of critical concern (even though it was present in 'everyday' legal contexts-for example, identifying risk factors and making predictive judgements in relation to detention, imprisonment, mental health, child protection, asylum or deportation). instead, it was for the most part accepted as an uncontroversial component of the expert, scientific evidence put forward in support of one's legal arguments. but a change has taken place due to the new societal emphasis on (in)security and public protection. significantly, in some jurisdictions, the new post / national security context has generated strong demand for greater prioritisation of risk -even if this comes at the expense of established human rights norms. the risk and rights relationship, in other words, is being framed as risk or rights-and rights seem to be at a substantial disadvantage. there is though a new critical counter-terrorism scholarship which is fighting this dangerous turn. in our view, its arguments need to be read very closely by those working on public health emergency preparedness, not least because of the effect that a 'risk or rights' approach could have on the interpretation, and use, of the ihr and the design, interpretation and use of national preparedness measures. three insights from critical counter-terrorism scholarship merit particular attention. first, it should not be assumed that the human rights argument has been won: the reasons why human rights need to be protected have to be explained again and again, without fail. arguments, especially official ones, which insist that human rights norms have no place in times of emergency mean that counter-argument needs to be seen as constant requirement. secondly, defending human rights in an era of heightened security-consciousness entails not just closer engagement with the contemporary politics of security, but also recognition of the value of security. and, thirdly, a human rights spotlight on the language and practices of risk assessment and management is essential in order to evaluate the legitimacy of responses to public health threats. in thinking about risk within rights in the context of public health emergency preparedness, these points suggest a range of strategies. for example, the use of coercive measures-such as quarantine-requires particularly strong justification. these measures infringe liberty and privacy rights and, if mistakes are made, healthy individuals are put at serious risk of infection. the threat of quarantine can lead individuals to delay seeking diagnosis and treatment. it can also provoke or compound discrimination and stigmatisation of particular individuals and groups. and, as lucia zedner has pointed out, the use of risk categories to target certain groups can create a further problem: at one level, it makes perfect sense to target security measures at those deemed most to threaten. yet an inherent danger of selectivity is that precisely because it imposes restrictions only on targeted sections of the population, it is less likely to invoke the natural political resistance generated by burdens that affect us all. med.l.rev. critical counter-terrorism scholarship should also be seen as relevant in developing an account of risk-based evidence and its relationship to human rights. some public health commentators, discussing coercive measures, have begun to advocate a direct linkage between risk expertise and human rights standards: an approach, which might enable the formulation of a body of public health ethics acceptable to human rights jurisprudence is to introduce into the language of ethics and rights the notion of evidence-based assessment of risk. this approach, they argue, could help to bring consistency and coherence to the 'balancing [of ] the common public health good with individual rights'. for this to be true, critical counter-terrorism scholarship suggests that two particular problems will need to be addressed: the first concerns the terminology of balance; the second concerns the nature and role of risk-based evidence in legal processes. the metaphor of balance-which is now widely used in debates about appropriate legal responses to the risk of terrorism-has the potential to undermine human rights. as andrew ashworth has argued, the imagery of balancing assumes a 'hydraulic relationship between human rights safeguards and the promotion of security': specifically, 'as one goes up the other must go down, and vice versa'. balancing, unlike proportionality, 'involves a broad brush, and sometimes opaque, analysis aimed at a resolution of the interests at stake and the rights involved'. it uses a 'utilitarian analysis of the rights and public interest goals in question, giving no significantly greater weight to rights than to security measures'. proportionality, in contrast, is more protective of human rights: specifically, under the proportionality approach, there is a presumption that rights restrict public interest goals. rights outweigh goals that are not legitimate and, where goals are legitimate, any measures giving effect to them must be suitable, the least restrictive possible, and proportionate between the effects of the measures and the objectives to be achieved. coker and others, above n , at . ibid., at (emphasis added). the second issue is risk-based evidence. a striking feature of contemporary security debates, in the terrorism and public health fields, is the increased reliance on risk-based evidence and expertise. human rights scholars have argued that, if risk evidence is to be used to justify limitations on rights, the evidence of threats to security must be disclosed and scrutinised according to identifiable legal norms. clearly, where there is litigation, it is the judges' approaches to risk that will be crucial. historically, many types of expert evidence pertaining to public or national security were viewed as non-justiciable. and, where judicial intervention did occur, the actual level of scrutiny was often minimal and deferential to government assertions and experts. today, however, what we have labelled as 'risk within rights' is beginning to be openly articulated by the judiciary in security contexts. specifically, in some jurisdictions, in response to concerns about the nature, and direction, of recent antiterrorism legislation and practice-including preventative detention, surveillance and deportation of suspected individuals-judges have started to engage openly, and more critically, with the relationship between risk and human rights. this is a welcome development. but a wider and deeper engagement will be needed in order to dislodge the zero-sum representation of risk and human rights, and among other things this will require an exploration of the tendency to think of risk as an expert, rational or scientific knowledge, and human rights as a value-based legal knowledge. we shift now to the complex terrain of 'rights as risk'. as noted earlier, the prompt for this second frame is that risk management has become a pre-eminent concern for governments and organisations (whether public, private or public -private in character)-to quote michael power, we are in the midst of 'the risk management of everything'. in this section, we focus on organisational risk, emphasising that this includes management of the risk of rights, and we consider what this might mean for the project of human rights preparedness. as we explain below, we take the view that a human rights engagement with 'rights as risk' is both necessary and undeniably complex. organisational risk is an umbrella term covering the possible risks affecting an organisation (including, for example, government departments, regulatory bodies and pharmaceutical companies). the organisational risks that have to be managed vary widely and are generally classed as reputational, financial, legal, political and operational in nature. the regulatory space in which the organisation operates will be a key factor. influences, demands and obligations can be exerted from numerous directions-for example, from international institutions, governments, state regulatory bodies, courts, professional associations, corporations, shareholders, trades union, litigants, ngos, the public and the media. human rights are a particularly complex organisational risk. they encompass, but are not limited to, legal risk: that is, ( potential) claims and litigation for human rights law violations. rather, because human rights are more than human rights law, rights as an organisational risk are also about the capacity of human rights consciousness (as manifested, for example, in community group protests) to adversely affect the interests of the organisation. furthermore, for an organisation, risks exist in both engaging with, and rejecting, human rights. michael likosky, discussing the imperative of governments and private companies to manage human rights risks in joint projects, emphasises that organisations' risk-mitigation strategies will vary. for example: do they address the underlying human rights problem itself, making a project more respectful of human rights? do they discredit the ngo or community group campaign? do they negotiate with one ngo but not with another? do they assuage the concerns in the public health emergency field, a wide range of influences, demands and obligations have the capacity to lead to the construction of rights as a risk. indeed, the cross-sector and cross-jurisdiction nature of public health emergencies (especially those of 'international concern') creates an especially complex governance landscape: distinct histories, cultures and agendas will be colliding in times of crisis when immediate responses are expected. in what follows, we outline a range of reasons why, from an organisational risk perspective, rights are likely to seen as a risk in the field of public health emergency preparedness. one obvious source of risk is the mounting number of human rights instruments and, as a result of increased litigation and the migration of legal arguments, the worldwide expansion of human rights-referencing case law. the campaign to expand corporate liability for human rights violations is another source: although corporate opposition to new legally binding duties persists, this campaign has encouraged companies to commit to improved self-regulation. another source is the human rights demands found within the conditional loan agreements between international organisations (such as the world bank) and recipient governments, or within the contractual and public procurement rules relating to the providers of public goods and services. global health governance is also characterised by an increasingly influential role for hybrid and non-state actors, including ngos (such as médecins sans frontières), public-private partnerships (such as the global alliance for vaccines and immunisation (gavi)), and private foundations (such as the gates foundation). indeed, in evidence to a uk parliamentary committee, david fidler stated that: increasingly, the gates foundation is the first place people will pick up the phone to call; not the who. in fact, someone told me -and i do not know if this is true -that bill gates is now going to fly to indonesia to help intervene in that controversy over virus sharing. something has changed here. in federal states, the legal relationship between federal and local government may constitute rights as a risk in the public health emergency field. on the one hand, a strong states' rights tradition can hamper, or be used as an excuse by, federal government in developing particular national preparedness measures. on the other hand, however, where federal government seeks aggressively to assert its power and interfere with protected human rights, a tradition of strong states' rights could be a bulwark against such abuse. the levels of public trust in a particular national culture will also influence rights as risk perspectives. lesley jacobs, in a study of the divergent uses of quarantine in hong kong, shanghai and toronto during the sars crisis, attributes the more extensive use of quarantine in toronto to the particular legal consciousness of senior public health officials: 'health security was weighed much more heavily than rights concerns . . . whereas in hong kong and shanghai there was much more of an even balance'. but, even though there was dissent in toronto, courts and human rights bodies were not used to raise concerns about rights violations. one federal public health official has speculated that: the belief that the decisions about sars by senior public officials, provided that they had a legal basis, would be made fairly was so deeply ingrained among the public that there was little need to question or scrutinize those decisions. jacobs's explanation for the non-use of courts is that legal avenues of redress might not be seen as appropriate 'where the health security of the community is at stake'. from an organisational risk perspective, this phenomenon could be used as a reason to dismiss rights as a risk and, more specifically, to downgrade the need for rights protection in house of lords select committee, above n , at . medical law review [ ] preparedness planning and implementation. this, however, would be counter-productive. as james childress and ruth gaare bernheim have argued, 'public justification, deliberation, and other relationshipbuilding activities may be more important for biopreparedness than state power because they maintain and nurture civic ideals, cooperation, and trust'. moreover, childress and gaare bernheim's argument can be extended to encompass the role of the private sector in sustaining public trust during an emergency. to give just one example: an employer's policy on matters such as job security has a very real capacity either to aid or to hinder the extent of voluntary compliance with quarantine requirements. but it is not just national cultures that merit attention in thinking about rights as risk: organisational cultures also 'shape how human rights are framed, interpreted and institutionalised'. article ( ) of the ihr states that implementation of the regulations is to be 'with full respect for the dignity, human rights and fundamental freedoms of persons'. the extent of internalisation of human rights within who is, therefore, crucial. little, however, is known about this as the organization has not been the focus of human rights or, indeed, regulation scholarship. but it is obvious that the range of internal staff responses will play a significant role in the design, implementation and monitoring of any human rights-based policies. we can also speculate that any internal divisions on human rights will both increase who's own exposure to organisational risk and affect the handling of the specific human rights matter in question. consider, for example, galit sarfaty's study of interpretations of human rights at the world bank. comparing world bank investment projects relating to hiv/aids prevention in russia and saint lucia, sarfaty speculates on the reasons why different framings of the human rights dimension were adopted in each case: one reason may be that the project team was dominated by staff who prefer a cost-benefit analysis to a legal approach, and who concluded that funds would be better spent on other preventative projects. she also highlights two different core approaches to human rights among world bank staff: she labels the first 'instrumental' and the second 'intrinsic'. staff who adopt an intrinsic framework draw on either moral or legal imperatives and, overall, they see human rights in normative terms as an end in themselves. the instrumentalists, in contrast, see rights as a means to an end, using a functionalist, economics-driven rationale to determine whether, and how, human rights have value in any given case. we believe that thinking about 'rights as risk' should be a key aspect of human rights preparedness. human rights advocates need to recognise the growing significance of organisational risk and, in particular, the ways in which organisational culture intertwines with risk and rights. in addition, human rights needs to reflect on the emergence, from within its ranks, of the 'human rights risk strategist'. likosky, discussing public -private partnership infrastructure projects in different countries, highlights how governments and other organisations may aim to 'advance human rights interests for their own ethical or strategic reasons', and may therefore enter into negotiations and alliances with certain ngos. human rights 'risk consultants', drawn from legal and other backgrounds, may also be employed by governments and organisations, to offer expertise on particular projects and human rights campaigns. looking specifically at the public health emergency context, it can be argued that who's new power under the ihr to use information about disease outbreaks provided by unofficial sources gives governments an added incentive to work with ngos and this, in turn, gives ngos increased influence. the end result is likely to be a mixture of human rights agendas, including-and this is the key point-human rights advocates adopting instrumentalist strategies and language (for example, urging the need to avoid 'business risk') in order to promote human rights protection. there is a lot for human rights advocates to address here. one question that needs to be asked is: are human rights risk strategists at work in public health preparedness projects and, if so, in what ways? are they, for example, picking up on the argument made by francis that it is not merely questions of justice within pandemic planning that demand attention but also the justice of pandemic planning: the triage choices in pandemic planning for the distribution of vaccines and antivirals are open, coordinated, and institutionally adopted. perhaps this is one reason why they have drawn so much attention. . . . no doubt there are other explanations, too, for the apparent assumption that devoting resources to pandemic planning is just. . . . nonetheless, there are serious questions of justice to be asked about the allocation of extensive resources to pandemic threats. and, as they go on to point out, questions concerning the 'justice of' and 'justice within' pandemic planning are not unrelated. put shortly, if basic health care infrastructure is in a state of neglect or unavailable, if health professionals are in short supply or are not trusted by the population, and if there is inequality in access to primary care, then global surveillance, surge capacity and, more generally, preventing and coping with a pandemic will be all the more difficult. 'pandemic myopia', in other words, is a seriously flawed approach to pandemic planning -which is surely something that human rights advocates (whether they see themselves as 'risk strategists' or not) need to be arguing as strongly and clearly as possible. there are other, broader questions too. these stem from the fact that rights as risk is not home-ground for human rights advocacy. put bluntly, it smacks of bad faith, of working on 'their' terms, not on 'ours'. being 'at the table', if that course is chosen, is not likely to be at all easy in practice. the counter-argument to this is that human rights advocacy has always been complex. think, for example, of the diversity of human rights advocates (such as the us christian right at the united nations using human rights to argue against rights to sexual and reproductive health). and it cannot be denied that human rights 'victories' have sometimes had unexpected, negative consequences: on occasion, they have been used by governments as a basis from which to claim that action has been taken and no further governmental action is required. it can also be argued that if deeper engagement with human rights by governments and other organisations (even if primarily through the lens of risk management) is a significant contemporary dynamic, then human rights advocates have little choice but to respond in some fashion. and it should not be forgotten that risk-based indicators and compliance strategies have also been growing areas of interest within human rights work. lastly, there is, of course, the possibility that an organisation that starts out with an instrumentalist mindset towards human rights might ultimately internalise them to beneficial effect. overall, then, human rights advocates should not-and probably cannot-avoid engaging with rights as risk. one of the conclusions in the report of a recent uk parliamentary committee on infectious diseases and global health governance is that who needs additional funding 'if it is to be able to respond effectively to threats on behalf of the international community'. this statement is a reminder of the importance, and the fragility, of public health emergency preparedness. it is likely that it will also be read, at least by some, as a rebuke to individuals, like us, who set out to critique preparedness when it is currently so precarious in practice. critiquing public health emergency preparedness is undeniably hard. who, in the end, would choose to be 'against preparedness'-especially when one considers the extreme human costs of recent public health emergencies? we are not against it, however. our argument throughout has been that critique is essential to preparedness and that, to date, critique from a human rights perspective has been in short supply. we have suggested a preliminary agenda to address the human rights gap, focusing in particular on the frames 'risk within rights' and 'rights as risk', and we assigned the name 'human rights preparedness' to the project as a whole. we concluded by turning inwards, emphasising that this project carries risks for human rights itself. specifically, critiquing preparedness could well involve self-critique as human rights advocacy works towards a more differentiated analysis of how security should be engaged and what it means to do human rights today. putting that another way, human rights preparedness-and, in particular, engagement with 'rights as risk'-is likely to be human rights without a safety net. human rights, terrorism and risk: the role of politicians and judges civil liberties law: the human rights act era see the discussion of uk and canadian national security cases in t poole regulation and administrative constitutionalism designs on nature: science and democracy in europe and the united states risk and human rights: ending slopping out in a scottish prison legal knowledges of risk' in law commission of canada risk, rights and public health emergencies infrastructure and human rights (cup a common law of human rights? transnational judicial conversations on constitutional rights the un human rights norms for corporations: the private implications of public international law between light and shadow: the world bank, the international monetary fund and international human rights law the new corporate accountability: corporate social responsibility and the law (cup risk, rights and public health emergencies pandemic planning and distributive justice in health care on the need to take account of social justice in pandemic planning, especially the needs and interests of the most disadvantaged, see the bellagio statement of principles globalizing family values: the christian right in international politics risk, rights and public health emergencies key: cord- - pumvst authors: himmelstein, david u.; woolhandler, steffie title: the u.s. health care system on the eve of the covid- epidemic: a summary of recent evidence on its impaired performance date: - - journal: int j health serv doi: . / sha: doc_id: cord_uid: pumvst four decades of neoliberal health policies have left the united states with a health care system that prioritizes the profits of large corporate actors, denies needed care to tens of millions, is extraordinarily fragmented and inefficient, and was ill prepared to address the covid- pandemic. the payment system has long rewarded hospitals for providing elective surgical procedures to well-insured patients while penalizing those providing the most essential and urgent services, causing hospital revenues to plummet as elective procedures were cancelled during the pandemic. before the recession caused by the pandemic, tens of millions of americans were unable to afford care, compromising their physical and financial health; deep-pocketed corporate interests were increasingly dominating the hospital industry and taking over physicians’ practices; and insurers’ profits hit record levels. meanwhile, yawning class-based and racial inequities in care and health outcomes remain and have even widened. recent data highlight the failure of policy strategies based on market models and the need to shift to a nonprofit social insurance model. a randomized trial carried out by the u.s. treasury department has again confirmed that health insurance saves lives. in , the internal revenue service sent informational letters to . million taxpayers randomly selected from the . million who had paid tax penalties for failing to comply with the coverage mandate of the affordable care act (aca). the letters provided information about penalties and insurance plan costs, together with instructions on how to investigate the availability of medicaid and aca exchange coverage. in the subsequent years, coverage rates were . percentage points higher among persons who received a letter. moreover, the death rate among adults age to who received a letter (vs those who did not) was . percentage points lower, equivalent to death averted for every , individuals in that age group who were sent a letter. when americans turn and gain medicare coverage, cancer detection rates, particularly for early-stage disease, increase sharply for breast, colorectal, and lung cancer, and mortality rates fall. yet another indicator that americans are struggling to afford care: about million people have started a crowdfunding campaign to pay for medical care for themselves or a household member on sites such as gofundme. another million people started campaigns for someone outside of their household. a new study of the burden of health costs borne by different income groups -the first to encompass costs for institutionalized persons -suggests that the u.s. health care financing system is even more regressive than previous work had indicated. total health care payments, including premiums paid by workers and their employers, taxes paid, and out-of-pocket spending, consumed . % of income for the poorest fifth of the population, but only % for the wealthiest fifth. a new npr/robert wood johnson foundation/ harvard school of public health survey has found that even wealthy americans sometimes have difficulty affording care. among the wealthiest % of adults (those with household incomes above $ , ), % reported a serious problem paying medical bills within the past few years, % had a serious problem paying for prescription drugs, and % reported a serious problem getting health care when needed. among the wealthy, % said they had failed to fill a prescription or had cut back on dosages in the past year due to prescription costs. lower-income adults encountered all of the cost and access problems much more frequently. in the decade ending in , the average premium for an employer-sponsored family plan increased from $ , to $ , ; the employee's share of the premium increased from $ , to $ , ; and the average deductible increased from $ , to $ , . meanwhile, median household income increased modestly, from $ , to $ , (not adjusted for inflation). by eliminating the financial burden of copayments, deductibles, and co-insurance, improved medicare for all would cut the poverty rate by . %, according to data from the u.s. census bureau's march current population survey. out of the . million people living below the poverty line, cutting costsharing for health care would lift million out of poverty. an official estimate from the centers for medicare and medicaid services (cms), released prior to the covid- epidemic, predicted that u.s. health expenditures would grow by . % annually between and , reaching $ . trillion ( . % of gross domestic product) by the end of the period. the harms of copayments providing essential medications without charge increased adherence to treatment and significantly lowered blood pressure among canadians prescribed an antihypertensive drug, according to a randomized, controlled trial in ontario. (canada's single-payer system does not include universal drug coverage, an omission that the ruling liberal party promised to address during the election campaign last fall.) hemoglobin a c and ldl cholesterol levels also fell slightly, but nonsignificantly, in the free medications group. a new study finds that veterans health administration (va) patients, relative to americans with non-va coverage, are only about half as likely to skip a prescribed medication because of costs ( . % vs . % of others), despite va patients having lower average incomes. va coverage especially improved drug adherence among people with chronic illnesses, while shrinking racial/ethnic and income-related disparities. the va provides free prescription drugs to some patients, while charging others copays of $ per month for preferred generics and $ per month for brandname drugs, with annual out-of-pocket drug costs capped at $ . yet despite charging patients less, the va's drug spending is lower than that of private insurers because it pays drug manufacturers lower prices. when the dutch government instituted new copayments for mental health care, the use of mental health services for both severe and mild disorders decreased abruptly and persistently, particularly in low-income neighborhoods. meanwhile, the number of involuntary commitments increased by . % and episodes of acute mental health care rose by . %. while overall costs decreased by $ . million, costs increased $ . million for adults with psychotic or bipolar disorders. a recent study indicates why the us advocacy organization physicians for a national health program calls for improved medicare for all. among seriously ill medicare enrollees (i.e., those who have visited or more physicians and been hospitalized at least twice in the past year), % had a serious problem paying a medical bill, % had used up all or most of their savings, % had been contacted by a collection agency, and % were unable to pay for basic necessities. while almost all persons older than are covered by medicare, % of them lack dental coverage, and each year about % of them skip needed dental care because they cannot afford it. about % of seniors have lost all of their teeth, and many more have tooth and gum problems that compromise their nutritional status and pose other health threats. medicare provides full coverage for the first days of skilled nursing facility care, but after that, patients are responsible for copayments of more than $ (all dollar amounts in u.s. dollars) per day. skilled nursing facility discharge rates for medicare patients spike on the th day of their stay and are especially high for black and hispanic patients and those from low-income zip codes. patients discharged on day also had significantly more comorbidities than those discharged on other days, indicating that financial rather than medical reasons motivated their discharges. recent declines in u.s. life expectancy and deaths due to "diseases of despair" among working-age white people have gained wide attention. but a new study highlights rising mortality rates among working-age people of color and other disturbing trends dating to the s and earlier. population-wide life expectancy improved dramatically between and the early s, but improvement slowed starting in the s, plateaued starting in , and deteriorated between and . midlife mortality has been increasing since , and a wide variety of causes -not just diseases of despair -have contributed to the increase. native americans have suffered the worst midlife mortality increases (a % increase since ), and they now have the highest death rates of any race/ethnicity group ( % higher than non-hispanic whites). midlife mortality for blacks began increasing in and is currently % higher than non-hispanic whites. although each of these groups experienced large increases in fatal drug overdoses (with the largest increase - % since -among the black population), deaths from many other causes also increased. maternal mortality was % higher for blacks than for non-hispanic whites in ( . vs . per , live births), according to new data from the centers for disease control and prevention. hispanics' maternal mortality rate was the lowest, at . per , . many wealthy nations have poverty rates comparable to the united states' before accounting for the effect of social programs. but their more robust safety nets cut their poverty rates to levels far lower than ours. while government programs cut the poverty rate in the united states from . % to . %, comparable figures for finland are . % to . %; for denmark, . % to . %; for france, % to . %; for germany, . % to . %; and for italy, . % to . %. in the united states, the ratio of chief executive officers' (ceos') pay to the average workers' income rose from less than : in to : in . between and , private insurance costs per enrollee grew by . %, far faster than cost growth in medicare ( . %) or medicaid ( . %). for big health insurers, was a banner year. the profits of the largest u.s. publicly traded insurers increased % from , to $ . billion, driven by a wave of mergers and acquisitions. hospitals and outpatient practices may be struggling, but unitedhealth, the nation's largest private insurance firm, is doing just fine. in the quarter ending march , , the company made a profit of $ billion, an increase of $ million over the same quarter in . its "medical loss ratio," the portion of premiums that actually pay for care, fell to % (implying an overhead of %) from % in . yet another medicare advantage (ma) scam: collect premiums from medicare, while patients get their care from the va. about . million veterans are dually enrolled in an ma plan and the va. during a -year period, one quarter of dual ma/va enrollees undergoing coronary revascularization procedures had their procedures at a va facility, increasing costs for the va system -and saving ma plans -$ . million. the justice department has filed suit against anthem (owner of many for-profit blue cross plans) for medicare fraud, charging that the giant insurer combed ma enrollees' charts for additional diagnoses that would boost the ma premiums paid by cms, but then failed to delete inaccurate diagnostic codes that it discovered. anthem's chart reviews generated about $ million annually in extra payments between and . the suit comes after a department of health and human services inspector general's report found that ma plans had increased their risk-adjusted payments by $ . billion in based on chart reviews, and that for % of the chart review-based diagnoses, no visits, procedures, tests, or supplies were recorded in the chart. hence, according to the inspector general, while "beneficiaries may not have received any other services for the . . . diagnoses . . . medicare paid billions in ma risk-adjusted payments to provide care for these beneficiaries." more than in ( . %) privately insured patients undergoing surgery with an in-network surgeon and facility received a "surprise" bill for out-of-network care, most commonly for an out-of-network surgical assistant or anesthesiologist. the bills averaged $ , ; patients covered by aca exchange plans more frequently received out-of-network bills ( % of procedures for aca exchange plans vs % for non-exchange plans). surprise bills are even more likely after an emergency department (ed) visit or overnight hospital stay: . % of visits by privately insured patients to an in-network ed resulted in a "surprise" bill for out-of-network care in , up from . % in . similarly, . % of privately insured inpatient admissions at in-network hospitals resulted in an out-of-network bill, up from . % in . in , the out-of-network bills averaged $ per ed visit and $ , per inpatient stay. the partnership for america's healthcare future, an "astroturf" group funded largely by insurance and drug firms to oppose reforms that threaten their interests, bought half of all political ads in iowa during the runup to the presidential primary in the summer of . most of the ads bashed medicare for all. hospital leaders and policy wonks often claim that the recent wave of hospital mergers and acquisitions will improve efficiency and upgrade quality. however, previous studies found that the consolidation of hospital ownership has raised prices, and a new analysis refutes the claim that mergers improve quality. performance on measures of patient experience declined at hospitals acquired by a larger system between and as compared to other hospitals. neither mortality rates nor hospital readmission rates improved in the newly acquired hospitals. affiliation with a large system has also been trumpeted as a solution to the woes of struggling rural hospitals. but a new study indicates that, although affiliation improved rural hospitals' finances, it led to significant reductions in the availability of diagnostic imaging technologies, obstetric and primary care services, and outpatient care. many "nonprofit" health systems rake in enormous profits. in , kaiser foundation health plan and hospitals had an operating surplus of $ . billion. other big gainers included: mayo clinic ($ million), indiana university health ($ million), intermountain health ($ million), the university of pennsylvania health system ($ million), new york-presbyterian ($ million), and partners healthcare system, now renamed mass general brigham ($ million). many leading academic medical centers are highly profitable, but provide only modest amounts of care for medicaid or uninsured patients. the mayo clinic's record is especially egregious, and its ceo openly instructed employees to prioritize privately insured patients over those covered by medicaid. the clinic realized an operating surplus of $ million in , but charity care accounted for only . % of expenses (half the level of the cleveland clinic), and just % of medical care revenue came from medicaid, versus % at cleveland clinic and . % at cedars sinai in los angeles. hospitals in new york have filed almost , lawsuits against patients since seeking to collect on unpaid bills. the suits included , by new york university's winthrop hospital and , by northwell's north shore university hospital. many eds have closed in recent years, either because hospitals have been shuttered entirely or because hospitals that stayed open wanted to avoid often-unprofitable ed patients. a recent study found that when eds closed and patients' driving time to the nearest ed increased by minutes or more, the proportion of heart attack patients who received a percutaneous coronary intervention fell, and both mortality and readmission rates increased. kidney transplantation is the optimal treatment for most patients with end-stage renal disease (esrd), but only % of u.s. patients newly diagnosed with esrd receive a transplant or are placed on a transplant waiting list within year. esrd patients cared for at nonprofit dialysis facilities are times more likely to be placed on a transplant waiting list and % more likely to actually receive a transplant than patients at for-profit facilities, most of which are owned by giant firms, fresenius and davita. dr. michael apkon has up-close experience with care on both sides of the u.s./canada border. he was the chief medical officer at children's hospital of philadelphia before serving as the ceo of the hospital for sick children in toronto. he returned to the united states to become ceo of tufts medical center in . according to dr. apkon: what i saw was the impact [canada's single-payer system] has on the ease of access, the quality of the outcomes, and the social justice of the system . . . the moral distress [due to] barriers that are there because of the way the system is constructed, those were issues that i never faced in ontario . . . what i came to appreciate in canada is that there are things that markets are just not built to do. pay-for-performance, accountable care organizations, and "paying for value, not volume": more evidence of failure "next generation" accountable care organizations (acos) not only failed to save money, but actually increased medicare's costs by $ . million during and , according to a university of chicago study funded by cms. although the acos cut medicare spending on care by $ . million, the bonuses cms paid them greatly exceeded the savings. the findings add to the growing evidence that acos either increase costs or (at best) achieve only trivial savings. in california, % of the quality measures for medicaid-managed care plans have been stagnant or deteriorated since . three of the child-health measures currently in use have worsened, while others remained stagnant. for-profit plans scored markedly worse than nonprofit or public plans. a new study refuted the assertions of a widely cited new yorker article by atul gawande that a "hotspotting" program in camden, new jersey, markedly reduces health care costs and improves quality among "superutilizers," patients with very high use of health services. the new study randomly assigned patients to either the "hotspotting" intervention in camden or a control group that received usual care. the utilization of care fell markedly over time in both the intervention and control groups, but there was no difference in readmissions, hospital days, or hospital costs over days. another randomized clinical trial found that a chronic disease management program for patients hospitalized with chronic obstructive pulmonary disease (copd) actually worsened outcomes. the study compared usual care to an intervention that included transition support by specially trained nurses for days after hospital discharge to assure adherence with discharge plans and connection to outpatient care, as well as months of help for patients and families with self-management of copd. but the intervention group had more hospital admission and ed visits than the control group, without any improvement in patients' quality of life. primary care doctors and non-surgical specialists spent on average more than minutes per ambulatory encounter using electronic health records (ehrs), according to a study of about million encounters with , physicians who used cerner's ehr. one third of ehr time was spent on chart review, about one quarter on documentation, and % on entering orders; % of the interactions occurred on nights and weekends. the authors estimate that using the ehr took about minutes longer per encounter than using paper records. health care to cut workers' wages by %. palo alto online a mounting casualty of coronavirus crisis: health care jobs covid- hits some health care workers with pay cuts and layoffs. shots: health news from npr table b- . employees on nonfarm payrolls by industry sector and selected industry detail health insurance and mortality: experimental evidence from taxpayer outreach (nber working paper # ) does medicare coverage improve cancer detection and mortality outcomes? (nber working paper # ) straining to pay bills, more patients turn to crowdfunding. modern healthcare accounting for the burden and redistribution of health care costs: who uses care and who pays for it school of public health. life experiences and income inequality in the united states trends in employer health care coverage medicare for all would cut poverty by over percent. people's policy project national health expenditure projections, - : expected rebound in prices drives rising spending growth effect on treatment adherence of distributing essential medicines at no charge: the clean meds randomized clinical trial the effect of veterans health administration coverage on cost-related medication nonadherence association of cost sharing with mental health care use, involuntary commitment, and acute care financial hardships of medicare beneficiaries with serious illness high cost of dental coverage means seniors skip needed care. modern healthcare association between high discharge rates of vulnerable patients and skilled nursing facility copayments life expectancy and mortality rates in the united states maternal mortality in the united states: changes in coding, publication and data release poor america. the economist ceo compensation has grown % since . economic policy institute private insurance's costs are skyrocketing insurers reaped big financial gains from mergers in . modern healthcare unitedhealth group provides expansive support to covid- response efforts, reports balanced first quarter performance federal payments for coronary revascularization procedures among dual enrollees in medicare advantage and the veterans affairs health care system doj sues anthem for medicare advantage fraud office of inspector general. billions in estimated medicare advantage payments from chart reviews raise concerns (oei- - ) out-of-network bills for privately insured patients undergoing elective surgery with in-network primary surgeons and facilities assessment of out-of-network billing for privately insured patients receiving care in in-network hospitals the trailer: signs of change in elizabeth warren's campaign. washington post changes in quality of care after hospital mergers and acquisitions access, quality and financial performance of rural hospitals following health system affiliation most profitable not-for-profit healthcare systems mayo clinic wants to make rochester a global medical destination: but who benefits? modern healthcare new york hospitals have filed thousands of lawsuits against patients emergency department closures and openings: spillover effects on patient outcomes in bystander hospitals association between dialysis facility ownership and access to kidney transplantation q&a: the interest in preserving the status quo is very real. modern healthcare next gen acos aren't saving medicare money. modern healthcare a close look at medical managed care: statewide quality trends from the last decade. california health care foundation health care hotspotting-a randomized, controlled trial effect of a hospital-initiated program combining transitional care and long-term self-management support on outcomes of patients hospitalized with chronic obstructive pulmonary disease: a randomized clinical trial physician time spent using the electronic health record during outpatient encounters: a descriptive study the authors thank clare fauke for assisting in editing and compiling this report. the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. the authors received no financial support for the research, authorship, and/or publication of this article. david u. himmelstein, md, is a distinguished professor of public health at the city university of new york's hunter college, a lecturer in medicine at harvard medical school, and a staff physician at montefiore medical center in the bronx. he graduated from columbia university's college of physicians and surgeons and completed an internal medicine residency at highland hospital in oakland, california, and a fellowship in general internal medicine at harvard. he practiced primary care internal medicine and served as the chief of social and community medicine at cambridge hospital/harvard medical school. he cofounded physicians for a national health program, whose , members advocate for nonprofit, singlepayer national health insurance. key: cord- - d na s authors: jeong, han eol; lee, hyesung; shin, hyun joon; choe, young june; filion, kristian b; shin, ju-young title: association between nsaids use and adverse clinical outcomes among adults hospitalized with covid- in south korea: a nationwide study date: - - journal: clin infect dis doi: . /cid/ciaa sha: doc_id: cord_uid: d na s background: non-steroidal anti-inflammatory drugs (nsaids) may exacerbate covid- and worsen associated outcomes by upregulating the enzyme that sars-cov- binds to enter cells. to our knowledge, no study has examined the association between nsaid use and the risk of covid- -related outcomes. methods: we conducted a cohort study using south korea’s nationwide healthcare database, which contains data of all subjects who received a test for covid- (n= , ) as of april , . we identified adults hospitalized with covid- , where cohort entry was the date of hospitalization. nsaids users were those prescribed nsaids in the days before and including cohort entry and non-users were those not prescribed nsaids during this period. our primary outcome was a composite of in-hospital death, intensive care unit admission, mechanical ventilation use, and sepsis; our secondary outcomes were cardiovascular complications and acute renal failure. we conducted logistic regression analysis to estimate odds ratio (or) with % confidence intervals (ci) using inverse probability of treatment weighting to minimize confounding. results: of , adults hospitalized with covid- (mean age . years; female %), were nsaids users and , were non-users. compared with non-use, nsaids use was associated with increased risks of the primary composite outcome (or . [ % ci . - . ]) but insignificantly associated with cardiovascular complications ( . [ . - . ]) or acute renal failure ( . [ . - . ]). conclusion: while awaiting the results of confirmatory studies, we suggest nsaids be used with caution among patients with covid- as the harms associated with their use may outweigh their benefits in this population. coronavirus disease (covid- ) , which is caused by the severe acute respiratory syndrome coronavirus (sars-cov- ), is a global pandemic. [ , ] concerns exist that the use of nonsteroidal anti-inflammatory drugs (nsaids) may exacerbate covid- by upregulating angiotensin-converting enzyme (ace ) expressions, [ , ] the enzyme which sars-cov- binds to enter cells. in addition, nsaids inhibit cyclooxygenase (cox), [ ] which could be involved in the pathogenesis of viral infections to result in tissue damage. [ , ] these concerns were based on unconfirmed anecdotal reports of four young covid- patients who developed serious infectious complications following nsaids use. [ ] the health minister of france subsequently recommended that paracetamol (acetaminophen) be used as first-line antipyretic agents over nsaids. in contrast, the us food and drug administration, [ ] european medicine agency, [ ] and australia's therapeutic goods administration [ ] stated that there is insufficient evidence to draw conclusions regarding this safety concern and thus, current clinical practice should not be changed until further evidence becomes available. this position is supported by a recent systematic review of randomized trials and observational studies of respiratory viral infections, which concluded that there is currently no evidence to support that nsaids are harmful with respect to covid- . [ ] despite the widespread use of nsaids, to our knowledge, there is currently no published observational study that specifically assessed the association between nsaids use and clinical outcomes among covid- patients. this cohort study therefore aimed to examine the association between nsaids use, compared to non-use, and worsened clinical outcomes among adults hospitalized with a c c e p t e d m a n u s c r i p t page | covid- using south korea's nationwide healthcare database containing all covid- patients. we used the health insurance review and assessment service (hira) database of south korea, provided as part of the #opendata covid project, a global research collaboration on covid- jointly conducted by ministry of health and welfare of korea and hira. [ ] briefly, the south korean government released the world's first de-identified covid- nationwide patient data on march , . owing to south korea's national health insurance system, which is the universal single-payer healthcare provider covering the entire korean population of million, and its fee-for-service reimbursement system, the database includes information from both inpatient and outpatient settings. the hira covid- database contains data of all subjects who received a test for covid- as of april , , linked to their administrative healthcare data from the previous years (january , to april , ). the hira covid- database includes anonymized patient identifiers, sociodemographic characteristics, healthcare utilization history, diagnoses (international classification of diseases, th revision; icd- ), and drug prescription information (anatomical therapeutic chemical classification codes); use of over-the-counter drugs are not collected in this database (supplementary material ). [ ] this study was approved by the institutional review board of sungkyunkwan university (skku - - ), which waived the requirement of obtaining informed consent. a c c e p t e d m a n u s c r i p t page | of , individuals who received a diagnostic test for covid- between january , to april , , , tested positive for covid- ( figure ) we defined exposure using inpatient and outpatient prescription records of nsaids from the hira database, including both oral and intravenous formulations (supplementary material ). we ascertained exposure to nsaids according to an intention-to-treat approach, in which exposure was defined in the index period of days before and including cohort entry among hospitalized covid- patients. patients prescribed nsaids during this period were classified as nsaids users whereas those not prescribed nsaids during this period a c c e p t e d m a n u s c r i p t page | were classified as non-users. to minimize any time-related biases such as immortal time, [ ] follow-up was initiated from the date of cohort entry for both nsaids users and non-users. our primary outcome was a composite endpoint of in-hospital death, intensive care unit (icu) admission, mechanical ventilation use, and sepsis. our secondary outcomes were a composite endpoint of cardiovascular complications (myocardial infarction, stroke, heart failure), and acute renal failure. we defined outcomes using in-hospital icd- diagnostic codes and procedures using the national procedure coding system (supplementary material ). study outcomes were measured between the cohort entry date and the earliest of the date of hospital discharge or end of study period (april , ). we assessed sociodemographic and clinical factors considered to be associated with nsaids use and risk of the outcomes of interest. for sociodemographic factors, we assessed age, sex, and health insurance type at cohort entry; age was grouped into -year bands. clinical variables included comorbidities and use of co-medications assessed in the year before cohort entry (supplementary material ). we used the expanded benefit coverage codes in addition to diagnosis codes to define malignancy to minimize false positives. baseline characteristics were summarized for nsaids users and non-users using counts (proportions) or mean (standard deviation) for categorical or continuous variables, respectively. we calculated the absolute standardized difference (asd) to determine important imbalances between exposure groups, with asd ≥ . considered important. a c c e p t e d m a n u s c r i p t page | we estimated the cumulative incidence of the primary and secondary outcomes among nsaids users versus non-users. we used three outcome models using logistic regression to estimate odds ratio (or) with % confidence intervals (cis) of the association of interest. the first model was unadjusted. the second model included all covariates described above. the third model, considered our primary analysis, was weighted by propensity scores (ps) using the inverse probability of treatment weight (iptw) approach. [ ] the ps, or probability of receiving nsaids, was estimated using multivariable logistic regression analysis, with all confounders mentioned above included as independent variables. the c-statistic was used to determine model discrimination, with a value between . and . considered adequate to predict treatment status based on covariates included. [ ] the iptw approach involves weighting the inverse probability of receiving nsaids ( /ps for nsaids, and /( −ps) for non-user groups). we conducted sex-and age-stratified analyses, with age classified into three groups (< , - , ≥ years), for the risk of the primary outcome associated with nsaids use. in addition, we stratified by route of administration (oral versus intravenous) and by history of hypertension, hyperlipidemia, or diabetes mellitus. the ps were re-calculated in all subgroup analyses using multivariable logistic regression models. a c c e p t e d m a n u s c r i p t page | as there is currently no data available on how fast nsaids increase ace tissue expressions, we varied the exposure ascertainment window to days and days before and including cohort entry. patients prescribed nsaids during these periods were classified as nsaids users whereas those not prescribed nsaids were classified as non-users. follow-up was initiated from cohort entry. to examine the potential effects of confounding by indication, we compared nsaids to paracetamol as these are used for similar indications (supplementary material ). we classified patients based on their exposure to nsaids or paracetamol in the days before and including cohort entry, excluding those not exposed to one of the two drugs of interest and those who received both drugs during this exposure window. follow-up was initiated from cohort entry for both exposure groups. as outcome misclassification of sepsis from inaccuracy of coding or reverse causality between nsaids use and sepsis is possible, we repeated our main analysis by using a redefined primary outcome that was a composite endpoint of in-hospital death, icu admission, and mechanical ventilation use. a c c e p t e d m a n u s c r i p t page | first, to improve comparability between exposure groups, we excluded the most extreme % of ps values (iptw with trimming). second, we included the estimated ps, in addition to other covariates, into our multivariable logistic regression model. third, we stratified on the ps in deciles. last, we applied standardized mortality ratio weights (smrw) ( for nsaids, and ps/( −ps) for non-user groups). [ ] all statistical analyses were performed using the sas enterprise guide software (version . ). nsaids users ( %) and , non-users ( %). nsaids users were older than non-users there was no difference between the association between nsaid use and the risk of our primary composite endpoint by formulation of nsaids, sex, and histories of hypertension and hyperlipidemia ( figure ). however, we found effect modification in age groups (p-for-interaction < . ) and history of diabetes mellitus (p-for-interaction . ). findings from sensitivity analyses remained largely consistent, where all effect estimates showed positive associations between the primary outcome and nsaids users, as compared with non-users, when varying the exposure window, applying other methods involving ps, or redefining the primary outcome. when comparing to paracetamol, our sample size was greatly reduced, and there were no events that occurred in the nsaid group (cumulative incidence for nsaids users: . %; paracetamol users . %). results of sensitivity analyses for the secondary outcomes were also generally consistent ( figure ). to the best of our knowledge, this is the first population-based cohort study to have investigated the association between nsaid use and adverse outcomes among patients with likewise, despite use of nsaids known to result in nephrotoxicity [ , ] , our findings suggest no additional risk of acute renal failure when covid- patients were exposed to nsaids. the underlying pathogenic link between nsaids and covid- has yet to be elucidated. however, one animal study found increased ace expressions with nsaids (ibuprofen) [ ] in various organs such as the lung, heart, and kidneys. [ , , ] thus, ace upregulation induced by nsaids could theoretically heighten the infectivity of sars-cov- to worsen clinical outcomes, resulting in multiple organ failure in severe cases. other hypothetical mechanisms have also been suggested. nsaids could aggravate infections by upregulating cox- in activated b lymphocytes to interfere with antibody productions, [ ] or by selectively inhibiting interferon-γ productions that are vital for immunity against foreign pathogens. [ ] however, with inconsistent findings from animal studies and the precise biological mechanisms yet to be understood, it remains unclear as to whether these findings are readily transferable to humans. we defined exposure using an approach analogous to an intention-to-treat, with exposure assessed in the days before and including the day of cohort entry (hospital admission). we used this approach to avoid time-related biases that could be introduced by assessing in-hospital nsaid use as the date of prescription was not available for ~ % of inhospital prescriptions. the length of hospital stay not only influences the probability of being exposed to nsaids while hospitalized but is also associated with worse prognosis. however, with exposure defined using pre-hospital medication use, our exposure assessment was independent of in-hospital outcomes and the duration of hospital stay. although predicting the direction resulting from this bias is difficult as occurrence of confounders during hospitalization are accounted for in this study, the use of this exposure definition is likely to a c c e p t e d m a n u s c r i p t page | bias our findings towards the null. this is because, by not accounting for nsaid use during hospitalization, the observed increased risk is suggested to be a conservative estimate. our study has several strengths. to our knowledge, this is the first population-based study conducted using all hospitalized patients with covid- to assess the association between nsaid use and covid- related outcomes. moreover, we used a nationwide healthcare database of south korea that includes information on healthcare utilization of all covid- cases as of april , . therefore, our findings provide real-world evidence that is highly generalizable to everyday clinical practice. with its large source population, our data source was sufficiently large to assess this clinically important issue. in addition, our findings were consistent in sensitivity analyses that extended the index period. our study also has some limitations. first, outcome misclassification is possible. however, misclassification of in-hospital death is likely to be very small, and the validity of procedure codes to define icu admission or mechanical ventilation use are also expected to be high as these codes are used for reimbursement processes by the health insurance authority. also, the positive predictive value of diagnosis codes between claims data and electronic medical records was previously reported to be %,[ ] and we believe its validity to be greater for sepsis, myocardial infarction, stroke, heart failure, and acute renal failure as we restricted to hospitalized patients receiving close monitoring. second, our findings may have theoretically underestimated the association between nsaids users and clinical outcome due to depletion of susceptible patients,[ ] as we included prevalent users of nsaids. however, our study period included the start of the covid- pandemic in south korea, making it unlikely that patients who were susceptible to adverse covid- related outcomes were excluded prior to entering our cohort. third, our results may be affected by confounding by indication given our use of an unexposed reference group. despite attempting to address this by comparing nsaids users to paracetamol users, we were unable a c c e p t e d m a n u s c r i p t page | to provide meaningful results as there were no events among nsaids users upon excluding those prescribed both nsaids and paracetamol during the exposure window. this therefore suggests that the exposed events from our main analysis were exposed to both drugs during the exposure window, implying that these patients were severe cases who were world health organization. coronavirus disease (covid- ) situation dashboard rapid asymptomatic transmission of covid- during the incubation period demonstrating strong infectivity in a cluster of youngsters aged - years outside wuhan and characteristics of young patients with covid- : a prospective contact-tracing study are patients with hypertension and diabetes mellitus at increased risk for covid- infection? sars-cov- cell entry depends on ace and tmprss and is blocked by a clinically proven protease inhibitor roles of cyclooxygenase (cox)- and cox- in prostanoid production by human endothelial cells: selective up-regulation of prostacyclin synthesis by cox- hyperinduction of cyclooxygenase- -mediated proinflammatory cascade: a mechanism for the pathogenesis of avian influenza h n infection a tug-of-war between severe acute respiratory syndrome coronavirus and host antiviral defence: lessons from other pathogenic viruses update -coronavirus: french health minister and who issue warning over taking anti-inflammatories. the local france fda advises patients on use of non-steroidal antiinflammatory drugs (nsaids) for covid- . us food and drug administration ema gives advice on the use of non-steroidal antiinflammatories for covid- therapeutic goods administration. no evidence to support claims ibuprofen worsens covid- symptoms. therapeutic goods administration scientific brief: the use of non-steroidal antiinflammatory drugs (nsaids) in patients with covid- . world health organization ministry of health and welfare. #opendata covid . available at towards actualizing the value potential of korea health insurance review and assessment (hira) data as a resource for health research: strengths, limitations, applications, and strategies for optimal use of hira data world health organization. laboratory testing for coronavirus disease in suspected human cases: interim guidance. world health organization,. . . ministry of health and welfare rok. about covid- : patient treatment & management immortal time bias in pharmaco-epidemiology alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: a primer for practitioners reducing bias in a propensity score matched-pair sample using greedy matching techniques agence nationale de sécurité du médicament et des produits de santé (ansm) anti-inflammatoires non stéroïdiens (ains) et complications infectieuses graves -point d'information. l'agence nationale de sécurité du médicament et des produits de santé (ansm) risks related to the use of non-steroidal anti-inflammatory drugs in community-acquired pneumonia in adult and pediatric patients non-steroidal anti-inflammatory drugs and covid- acute respiratory infection and use of nonsteroidal anti-inflammatory drugs on risk of acute myocardial infarction: a nationwide case-crossover study risk of stroke associated with use of nonsteroidal anti-inflammatory drugs during acute respiratory infection episode cardiovascular safety of non-aspirin non-steroidal anti-inflammatory drugs: review and position paper by the working group for cardiovascular pharmacotherapy of the european society of cardiology vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials the invisible threat of nonsteroidal anti-inflammatory drugs for kidneys non-steroidal anti-inflammatory drug induced acute kidney injury in the community dwelling general population and people with chronic kidney disease: systematic review and meta-analysis ibuprofen attenuates cardiac fibrosis in streptozotocin-induced diabetic rats angiotensin-converting enzyme is a functional receptor for the sars coronavirus a crucial role of angiotensin converting enzyme (ace ) in sars coronavirus-induced lung injury ibuprofen and other widely used non steroidal anti-inflammatory drugs inhibit antibody production in human cells , and co-medications (angiotensin converting enzyme inhibitors, angiotensinreceptor ii blockers, β-blockers, calcium channel blockers, diuretics, nitrates, anticoagulants, inhaled therapy for respiratory for respiratory disease, lipid lowering drugs, opioids, oral glucocorticoids, platelet inhibitors, dipeptidyl peptidase- inhibitors, metformin, insulin, sulfonylurea, sodium-glucose cotransporter- inhibitors) ‡ ipt weighted multivariable logistic regression model (main model), where the propensity score used was estimated using a multiple logistic regression model that included the following independent variables: age, sex, health insurance type, comorbidities (hypertension, hyperlipidemia, diabetes mellitus, asthma, chronic obstructive pulmonary disease, malignancy, atherosclerosis, chronic renal failure, chronic liver disease, rheumatoid arthritis, osteoarthritis, gastrointestinal conditions, peripheral arterial disease, atrial fibrillation, other arrythmia, ischemic heart disease, pneumonia, psychiatric disorders, depression, thyroid disease), and co-medications (angiotensin converting enzyme inhibitors, angiotensin-receptor ii blockers, β-blockers, calcium channel blockers, diuretics, nitrates, anticoagulants, inhaled therapy for respiratory for respiratory disease, lipid lowering drugs, opioids, oral glucocorticoids, platelet inhibitors, dipeptidyl peptidase- inhibitors, metformin, insulin, sulfonylurea, sodium-glucose co-transporter- inhibitors) (c-statistics: . for nsaids users versus non-users) ⁋ cardiovascular complications include myocardial infarction, heart failure, and stroke ⁑ inestimable due to small number of events relative to the large number of confounders key: cord- -pi ifpcy authors: chan, raymond javan; emery, jon; cuff, katharine; teleni, laisa; simonsen, camilla; turner, jane; janda, monika; mckavanagh, daniel; jones, lee; mckinnell, emma; gosper, melissa; ryan, juanita; joseph, ria; crowe, bethany; harvey, jennifer; ryan, marissa; carrington, christine; nund, rebecca; crichton, megan; mcphail, steven title: implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase ii randomised controlled trial (the eminent trial) date: - - journal: trials doi: . /s - - - sha: doc_id: cord_uid: pi ifpcy background: due to advances in early detection and cancer treatment, -year relative survival rates for early breast cancer surpass % in developed nations. there is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. this study aims to test the feasibility of the eminent intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up. methods: we describe a protocol for a phase ii, randomised controlled trial with two parallel arms and : allocation. a total of patients with early-stage breast cancer will be randomised to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e. eminent). eminent is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer centre specialists (i.e. surgeons and oncologists) and general practitioners. the primary outcome is health-related quality of life as measured by the functional assessment of cancer therapy—breast cancer. secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events. discussion: the trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system. trial registration: australia and new zealand clinical trials registry actrn . registered on november discussion: the trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system. the order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit- -statement-defining-standardprotocol-items-for-clinical-trials/). in australia, breast cancer is the most common cancer in females with an estimated , new cases annually [ ] . with advances in early detection and cancer treatment, such as surgery, post-operative radiotherapy, and pre-or post-operative systemic therapies including cytotoxic chemo-, endocrine, and anti-her antibody therapies, the -year relative survival rate for breast cancer is estimated at % [ , ] . consequently, in , there were at least , breast cancer survivors living in australia [ ] . despite good survival outcomes, breast cancer survivors require supportive care including prevention of cancer recurrence, surveillance for secondary or new primary cancer, and management of a range of long-term bio-psycho-social effects from their cancer diagnosis and treatment. in addition, many cancer survivors need management of comorbidities as they are . times more likely to develop mental and behavioural problems and almost . times more likely to develop musculoskeletal conditions, circulatory conditions, and endocrine system disorders compared with non-cancer patients [ ] . these health concerns highlight the importance of a comprehensive, well-integrated, patient-centred model of care for people following completion of breast cancer treatment. the current models of post-treatment care in australia are mostly hospital-based and specialist-driven and focus on surveillance for disease recurrence, rather than the holistic care needs of cancer patients. this model of followup care limits the integration between specialist institutions and general practitioners (gps), overloads the specialist system, and is unsustainable to meet the demands of the ever-growing population of cancer survivors. specialist-based follow-up carries the burdens of travel and out-of-pocket costs such as those for parking. those in non-metropolitan areas face more major disruptions to engage in specialist-based follow-up. therefore, there is a strong case for an integrated, shared post-treatment follow-up care model for breast cancer survivors that involves both cancer specialists as well as care provided in the community by gps. such a shared-care model is consistent with cancer australia statements [ ] , the optimal care pathway for breast cancer [ ] , and international guidelines [ ] . in addition, the literature suggests that such a model is feasible, acceptable, safe, and more cost effective and patient-centred than current models used within australia [ , ] . despite the promising evidence base, a shared followup care model in which specialists in the acute cancer care setting and gps collaborate is not routinely implemented across australia and many developed nations. barriers to such shared care include the lack of a coordination between multiple providers, lack of patient and provider knowledge about the benefits of shared care and how to implement it, insufficient or delayed communication between cancer specialists and gps, and lack of awareness of available support such as funding models, tools, and resources [ , ] . these barriers could be overcome if a specialist cancer nurse advises stakeholders (patient and gps) of the benefits of sharedcare, facilitates effective and timely care coordination, and acts as the conduit between the specialist cancer multidisciplinary team and the gps at key transition time points, such as completion of definitive primary and adjuvant treatment [ ] . the objective of the study is to test the feasibility of a prospective, pragmatic randomised controlled trial (rct) of the eminent intervention-a nurse-enabled, integrated, shared-care model involving cancer specialists and gps for early breast cancer post-treatment follow-up. this phase ii pilot rct aims to assess the feasibility of a larger definitive clinical trial. outcome data will be collected at four timepoints (or five if booster nurse clinic is attended): (t ) baseline (at enrolment ± prior to booster nurse clinic, if relevant), (t ) months, (t ) months, and (t ) months. this study is conducted in a large, australian metropolitan tertiary teaching hospital and general practices. the study population consists of patients with earlystage breast cancer (i.e. no-distant metastases) or ductal carcinoma in situ (dcis). patients will be eligible to participate from weeks prior to completion of definitive treatment (surgery or adjuvant chemotherapy) and up to months after completion of treatment. patients meeting all of the following criteria are eligible for inclusion: diagnosis of curable, early breast cancer; receiving care at the princess alexandra hospital; able to speak and read english; years of age or older; ambulatory at the time of recruitment; eastern cooperative oncology group (ecog) performance status or ; able to nominate a gp or gp clinic to be involved in their follow-up; and access to a telephone. patients meeting any of the following criteria are excluded: presence of severe mental, cognitive, or physical conditions that would limit the patient's ability to provide informed consent. potential participants are identified by the research nurse or treating clinician during multidisciplinary team meetings. participants are approached by their treating clinicians to gauge their interest in the study and gain verbal consent to being approached by the research team. participants are then contacted by the research nurse, screened for eligibility, and provided with study information, and after a time of reflection (at least h), they sign the consent form with the research nurse. table outlines the different phases of the study and data collection. consent to access medicare and pharmaceutical benefits scheme (pbs) data on service use that qualifies under the medicare benefits schedule (mbs) will be obtained, including relevant claims details (date of service, medicare item number, and description) and costs details. survivorship care of breast cancer survivors following completion of treatment is an important issue, especially in light of improving survival rates [ ] . the shared-care model between specialists and gps focusses on the complex care needs of breast cancer survivors, rather than solely on disease recurrence, and may influence patient health outcomes and service outcomes [ ] . arm the control group will receive usual follow-up care supplemented with a survivorship booklet on living well after cancer published by cancer council australia [ ] . the usual care follow-up arrangement is a specialist-led model as determined by the treating surgeon, medical oncologist, and radiation oncologist. this specialist-led follow-up care is not standardised and with follow-up activities and schedules depending on individual patient needs and the discretion of the treating clinicians. eminent is a multi-faceted intervention that includes a pre-specified shared-care pathway for post-treatment follow-up. the design of the eminent intervention is informed by a number of cancer australia statements, the optimal care pathway [ ] , the self-efficacy model [ , ] , the capabilities for supporting prevention and chronic condition self-management framework [ ] , and our extensive pilot work including a systematic review [ ] and observational studies [ ] [ ] [ ] [ ] . table outlines the active ingredients of the eminent intervention. after enrolment, participants who have completed chemotherapy and radiotherapy or those who will receive aromatase inhibitor will participate in a -min telehealth cancer pharmacist consultation for medication reconciliation and education prior to specialist nurse consultation. a - -min consultation with a specialist cancer nurse is then conducted to provide a treatment summary, the shared follow-up care appointment schedule, and survivorship patient education (including the survivorship booklet on living well after cancer published by cancer council australia [ ] ) and to codevelop a draft survivorship care plan (scp). the scp includes up to three smart (specific, measurable, achievable, realistic, and timely) goals that are developed by the nurse and patient in partnership using motivational interviewing and self-efficacy techniques. due to the recent covid- pandemic, where there are delays of - months before gp involvement, a second 'booster' specialist cancer nurse consultation is offered to patients to update the scp. the treatment summary and draft scp is provided to the gp. within weeks of the specialist cancer nurse consultation, a - -min case conference between the specialist cancer nurse and the patient's nominated gp is completed to communicate the treatment summary and shared follow-up care schedule and to finalise the scp and negotiate the gp's role in facilitating the scp goals. the gp may propose changes or express if they are not willing to take part in specific care activities outlined in the scp. the finalised scp is then filed in the patient's medical records and provided to the patient and the gp. the shared, follow-up care schedule consists of monthly patient appointments with a cancer centre specialist and annual appointments with the gp for years post-diagnosis. following this, the schedule consists of alternating monthly appointments with a cancer centre specialist and gp for up to years post-diagnosis. at years post-diagnosis, patients are discharged to the care of the gp, as per usual care. the gp appointments will focus on reviewing the scp; promoting general health; primary prevention, screening, and management of comorbidities; psychosocial health; cancer treatment toxicities; cancer-related symptoms; chronic disease management planning; and allied health referrals. the gp has direct telephone access to the specialist cancer nurse in case of concerns or escalation for acute care review. the cancer centre specialist appointments focus on surveillance activities such as physical examination and imaging (i.e. annual mammogram). the presence of any of the following criteria constitutes cause for the withdrawal of the participant: altered mental capacity resulting in inability to provide continuing informed consent, notification from treating oncologist and/or gp that the participant is not deemed to have the capacity to consent, and recurrence or progressive disease or death. fidelity of the intervention will be assessed using the framework for behavioural interventions recommended by the national institute of health (nih) [ , ] as outlined in table . no concomitant care or intervention is prohibited during the trial. there is no ancillary or post-trial care for participants in this trial. however, it is expected that the scp generated will have the value of informing longer term updates of the scp and future survivorship care. the feasibility outcomes are recruitment and acceptability of the intervention. the primary endpoint is healthrelated quality of life (hrqol) as measured by functional assessment of cancer therapy-breast cancer (fact-b) [ ] at baseline, , , and months post-enrollment. the -item fact-b is a valid and reliable tool for use in cancer survivors undergoing as well as beyond treatment and has been demonstrated to be sensitive to changes over time [ ] . a total score as well as scores for each of the five subscales (physical, social/family, emotional, functional wellbeing, additional breast cancer concerns) are calculated, where higher scores indicate higher quality of life. fact-b captures key domains of hrqol and key symptoms that are relevant to the study population and sensitive to the eminent intervention. additional outcomes include a range of patientreported secondary endpoints, and process outcomes related to implementation as shown in table . participants of the intervention group, as well as their nominated carer, breast cancer nurses, gps, and other healthcare providers including other nurses, and hospital-and community-based rehabilitation providers will be invited to participate in a semi-structured interview. open ended questions (online supplementary material ) will explore key factors that facilitate or hinder the implementation of the eminent intervention. in this pilot study, we will recruit patients per arm in order to provide initial insights into the intervention feasibility and protocol as well as preliminary effect size estimates. the aim of this study is not hypothesis testing, and the power level is therefore not a valid consideration for sample size [ , ] . the sample size for this study (n = ) falls within the range of sample size recommendations for pilot studies of this nature [ , ] . participants are recruited through the hospital cancer outpatient clinics and therapy units. research nurses and designated health professionals identify potential participants. potential participants are reviewed by a member of the treating team and asked if they would like to be approached by a research nurse or designated table intervention fidelity strategies (adapted) training providers specialist cancer nurses will be trained to standardise the delivery of the intervention to study participants. training includes provision of study manual containing • generic study information: standard operating procedures, study overview, reporting and documentation guidelines, communication flowchart, rationale for the study treatment, completion of survivorship care plan, self-management goal setting, and health coaching • specialist cancer nurse-specific information: job description, intervention protocol, quality assurance, and monitoring an -h training program will be delivered by experts in cancer survivorship and motivational interviewing. the program includes the national cancer nursing education (edcan) learning module on survivorship, related literature, didactic presentations, and roleplay covering: basic concepts of quality cancer survivorship care, components of a high-quality treatment summary and survivorship care plan; provision of self-management support (including collaborative goal setting; motivational interviewing); and mbs item numbers that facilitate the proposed model of care. intervention procedures are monitored through completion of intervention component checklists to ensure that the intervention is delivered as intended. intervention checklists are completed during clinics and gp case conferences to track protocol deviations across specialist cancer nurses and study arms. the intervention fidelity is closely monitored and discussed during the weekly -min meeting for the first months of the trial between the specialist cancer nurses, research nurses, and investigators. minimising contamination between conditions by training interventionists to address participant questions about randomisation and their assigned condition using non-biased explanations. the scp serves as a resource for a participant to understand and refer to whenever they are unsure of follow-up schedule and collaborative goal setting. enactment of treatment skills enactment of treatment skills includes processes to monitor and improve participant ability to perform treatmentrelated behavioural skills and cognitive strategies in relevant real-life settings as intended. this goal will be achieved by ensuring participants are aware of the follow-up schedules and responsibilities of all health professionals, ensuring participants will have a copy of the completed scp including all care responsibilities and goals set for the individual, and checking in with participants once in the first week into the model, then monthly/bimonthly until the end of the trial period as resources allow. health professionals for consent to participate in the study. participants are given as much time as possible to consider their participation and are encouraged to take the information away and discuss participation in the trial with family, friends, and their gp if they so wish to. participants are also encouraged to ask the research nurses, their treating doctors, or nursing staff any questions in relation to their participation. computer-generated random numbers are used to allocate participants in a : ratio by a researcher not involved in recruitment, intervention implementation, or data collection. randomisation is blocked using random permuted blocks of eight and four to ensure that the groups are balanced periodically within stratification groups. stratification groups include patients who have received ( ) surgery only, ( ) surgery and radiation only, ( ) surgery and chemotherapy ± radiation and are her negative, and ( ) surgery and chemotherapy ± radiation and are her positive. these stratification groups were chosen, with clinician input, to allow learnings for patients with different treatment pathways with different follow-up needs to inform the future definitive trial. allocation sequence is implemented using sequentially numbered opaque, sealed envelopes. envelopes are only accessed by the research nurse to randomise the patient once recruitment and baseline data has been collected. eligibility screen x informed consent x allocation x health-related quality of life x x x x allocation sequence is generated by a researcher not involved in recruitment or data collection. patients are enrolled by a research nurse who collects baseline data prior to randomisation. enrolling nurses assign participants to the intervention after baseline data collection. who will be blinded { a} after assignment to the intervention, only outcome assessors are blinded to group allocation. where participants opt to complete their data collection by phone, they are advised not to reveal their group allocation to the outcome assessor. due to the nature of the intervention, no participants or treating clinicians are blinded. no unblinding procedures required as only outcome assessors and data analysts are blinded. plans for assessment and collection of outcomes { a} patient-reported outcomes are self-administered using online surveys or administered in person or via telephone with an outcome assessor trained in the administration of the study instruments. the description of study instruments is listed in table . the primary outcome is hrqol as measured by functional assessment of cancer therapy-breast cancer (fact-b) [ ] . this validated and reliable instrument is well-used in cancer survivors undergoing and beyond treatment [ ] , and it captures key domains of hrqol and key symptoms that are relevant to the eminent intervention. the secondary outcomes are listed below: patient experience of care as measured by the picker patient experience (ppe- ) questionnaire [ ] . the ppe- highlights aspects of care that need improvement to monitor performance and care. it consists of questions distributed to seven dimensions of care: respect, coordination, information/communication/education, physical comfort, emotional support, involvement of relatives, and transitions to community [ ] . dietary behaviours, specifically usual vegetable intake and usual fruit intake, as measured by two short dietary questions from the national nutrition survey [ ] , which have been validated in the australian population. both questions discriminate between groups with significantly different fruit and vegetable intakes. in administering these questions, information about which foods are included as vegetables and fruits is provided and serve sizes are described. physical activity as measured by the active australia survey [ ] which is designed to measure participation in leisure-time physical activity, and a single item from the international physical activity questionnaire [ ] will be used to measure sedentary behaviours. financial toxicity as measured by the -item comprehensive score for financial toxicity (cost)-functional assessment of chronic illness therapy (facit) tool [ ] . this tool is valid and reliable in measuring financial toxicity in patients with cancer [ ] . adherence to clinical assessments including annual mammography, annual physical examination, and endocrine therapy as measured by hospital records. emergency presentations and hospitalizations as recorded from hospital records. satisfaction of care as measured by a - numerical analogue scale with being the least satisfied and being the most satisfied, supplemented with short, structured qualitative questions. process outcomes, including completion of intervention components, as measured by completion of intervention materials such as scps and checklists, number and length of clinical encounters recorded from mbs data and hospital records, and barriers and facilitators to implementation as explored through semi-structured interviews with patient participants, their nominated carer, breast cancer nurses, gps, and other healthcare providers including other nurses, and hospital-and community-based rehabilitation providers. health resource utilisation assessing both health service use and participant out-of-pocket costs including mbs and pbs administrative data sets. these data inform participants' utilisation of services that qualify under the mbs as well as medications dispensed under the pbs. it is planned that the economic evaluation may be reported separately from the main trial. participants who deviate from the protocol are not withdrawn from the trial. participants who withdraw from the trial nominate the degree to which they withdraw (i.e. whether they withdraw from active data collection ± passive data collection such as mbs/pbs data). all participant characteristic and outcome data are entered directly into redcap (research electronic data capture -vanderbilt university, hosted at queensland university of technology) by the research nurse ± the participants through self-administered online survey. to ensure data quality, the database is designed with branching logic, data validation, and range checks for data values, where possible. all source data, clinical records, and laboratory data relating to the study will be archived at the clinical site as appropriate for years after the completion of the study. all data will be available for retrospective review or audit. no study document will be destroyed without prior written agreement between the responsible organisation and the investigator. if the investigator wishes to assign the study records to another party or move them to another location, he/she must notify the responsible organisation in writing of the new responsible person and/ or the new location. data on potential participants is recorded, including reasons for ineligibility or refusal to participate. participants are only identified by a unique participant study number on the case report forms and other study documents. other study-related documents (e.g. signed consent form, participant log) are kept in strict confidence by the investigator. participants are informed that data is held on file by the responsible organisations and that these data may be viewed by staff including the study project manager and by external auditors on behalf of the responsible organisations and appropriate regulatory authorities (to include reviewing human research ethics committee (hrec) and the research governance officers). participants will be identified in publication and conference presentation reports only in aggregated form. all participant data will be held in strict confidence. plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use { } not applicable. there is no collection of biological specimens in the current trial. descriptive statistics will be used to report on feasibility and process-related elements (e.g. recruitment, intervention, retention rates) as well as clinical and resource outcomes. preliminary effect size estimates for patient and resource use outcomes will be calculated following intention-to-treat principles using generalised linear mixed models. the distribution of the mixed models will be chosen as appropriate for the data, for example, a linear model for scale data or a poisson for count data. models will be adjusted for variables used in stratification of the randomisation process. residuals of all models will be examined for statistical assumptions using descriptive statistics and plots. not applicable. no interim analysis is planned. all qualitative interviews with participants assigned to the eminent intervention are audio-recorded and transcribed verbatim for analysis guided by the consolidated framework for implementation research [ ] . methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data { c} preliminary effect size estimates for patient and resource use outcomes will be calculated following intention-totreat principles using generalised linear mixed models. patterns of missing data will be examined using chisquare and t tests. missing data for the outcomes will be accounted for by using mixed models allowing the use of each available case by computing maximum likelihood estimates. plans to give access to the full protocol, participant leveldata, and statistical code { c} not applicable. there are no plans for granting public access of the full protocol, participant-level dataset, or statistical code. composition of the coordinating centre and trial steering committee { d} the chief investigators are the trial steering committee that will provide all governance to the conduct of the study. composition of the data monitoring committee, its role, and reporting structure { a} not applicable. there is no data monitoring committee established for this pilot trial. an adverse event (ae) is any event, side effect, or other untoward medical occurrences that occur in conjunction with the use of the study intervention in humans, whether or not considered to have a causal relationship to the interventions. an ae can, therefore, be any unfavourable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of the study intervention, whether or not considered related to the intervention. conditions recognised as being excluded from ae reporting are as follows: any event, side effect, or other medical occurrences that are anticipated because of the normal course of treatment (standard care). there are no known side effects/adverse events associated with the proposed model of care intervention [ ] . due to the nature of this intervention, there will be no reporting of ae. there are no plans for auditing trial conduct beyond the independent research governance requirements and annual reporting to the hrec. plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) { } all agreed protocol amendments are clearly recorded on a protocol amendment form and are signed and dated by the original protocol approving signatories. all protocol amendments will be submitted to the institutional hrec for approval before implementation. the only exception will be when the amendment is necessary to eliminate an immediate hazard to the trial participants. in this case, the necessary action will be taken first, with the relevant protocol amendment following shortly thereafter. once hrec approval has been granted, investigators and the anzctr will be updated. it is intended that the findings from this trial will be disseminated at academic and professional conferences and via a manuscript submission to a peer-reviewed journal. participants will be identified in such reports only in aggregate or by study identification number, gender, and age. there are no publication restrictions. despite the strong case for a shared, follow-up care model for breast cancer survivors involving cancer specialists and gps, barriers to shared care mean that it is not routinely implemented across australia. these include the need for coordination across multiple providers, the need for improved patient and provider knowledge about the benefits of shared care and how to implement it, insufficient or delayed communication between cancer specialists and gps, and lack of awareness of available support such as funding models, tools, and resources [ , ] . the current study aims to address these barriers using a specialist cancer nurse to advise stakeholders of the benefits of shared care (patient and gps), facilitate effective and timely care coordination, and act as the conduit between the specialist cancer multidisciplinary team and the gps. practical issues for this trial include estimating the time required to coordinate the trial across multiple providers including engaging gps and fidelity with the intervention components. the proposed study will provide important information on the feasibility of a definitive phase trial for implementing a nurseenabled, integrated, shared-care model involving cancer specialists and gps for early breast cancer posttreatment follow-up. the information collected through the trial, qualitative interviews, and economic evaluations are crucial in guiding the development of such a trial. the protocol published here is version . dated march . the trial began recruitment on december and is expected to continue until november . trial registration: australia and new zealand clinical trials registry, actrn . registered on november , https://www.anzctr.org.au/trial/ registration/trialreview.aspx?id= &isreview=true. responsible for delivering the pharmacist consult. all authors have provided input and have read and approved the final manuscript. this study is funded by metro south health research support scheme project grant (funded by the metro south study, education and research trust account (serta)). the funding body had no role in the design of the study and will not have a role in the collection, analysis, and interpretation of data or in writing the manuscript. there are no limitations on investigator access to the trial dataset. the datasets generated and/or analysed during the current study are not going to be made publicly available but will be made available from the corresponding author on reasonable request. this study is approved by the metro south hospital and health services human research ethics committee (hrec/ /qms/ ). written informed consent will be obtained from all participants. not applicable. no details, images, or videos relating to an individual person will be published, as all data will be presented in aggregate. australian institute of health and welfare. cancer data in australia. canberra: aihw australian institute of health and welfare australian institute of health and welfare. breastscreen australia monitoring report - australian institute of health and welfare. cancer compendium: information and trends by cancer type comorbidity, physical and mental health among cancer patients and survivors: an australian population-based study cancer australia statement -influencing best practice in breast cancer. surry hills: cancer australia victorian department of health and human services of clinical oncology breast cancer survivorship care guideline randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care a new model supporting best practice follow-up care for early breast cancer in australia: shared follow-up care for early breast cancer adult cancer survivors discuss follow-up in primary care: 'not what i want, but maybe what i need oncologists' perceived barriers to an expanded role for primary care in breast cancer survivorship care cancer nurses can bridge the gap between the specialist cancer care and primary care settings to facilitate shared-care models living well after cancer. a guide for people with cancer, their families and friends optimal care pathway for women with breast cancer national inst of mental health. prentice-hall series in social learning theory. social foundations of thought and action: a social cognitive theory cognitive processes mediating behavioral change capabilities for supporting prevention and chronic condition self-management. canberra: department of health and ageing and flinders university models of survivorship care provision in adult patients with haematological cancer: an integrative literature review nurses attitudes and practices towards provision of survivorship care for people with a haematological cancer on completion of treatment oncology practitioners' perspectives and practice patterns of post-treatment cancer survivorship care in the asia-pacific region: results from the step study mapping unmet supportive care needs, quality-of-life perceptions and current symptoms in cancer survivors across the asia-pacific region: results from the international step study provision of survivorship care for patients with haematological malignancy at completion of treatment: a cancer nursing practice survey study enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the nih behavior change consortium ensuring treatment fidelity in a multi-site behavioral intervention study: implementing nih behavior change consortium recommendations in the smart trial reliability and validity of the functional assessment of cancer therapy-breast qualityof-life instrument a systematic review of quality of life instruments in long-term breast cancer survivors considerations in determining sample size for pilot studies sample size of per group rule of thumb for pilot study the picker patient experience questionnaire: development and validation using data from in-patient surveys in five countries properties of the picker patient experience questionnaire in a randomized controlled trial of long versus short form survey instruments evaluation of short dietary questions from the national nutrition survey. canberra: australian government department of health and ageing australian institute of health and welfare. the active australia survey: a guide and manual for implementation, analysis and reporting international physical activity questionnaire: -country reliability and validity the development of a financial toxicity patient-reported outcome in cancer: the cost measure measuring financial toxicity as a clinically relevant patient-reported outcome: the validation of the comprehensive score for financial toxicity (cost) publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors acknowledge the contribution of drs kathryn middleton, wen xu, kate roberts, vladimir andelkovic, margo lehman, and tao supplementary information accompanies this paper at https://doi.org/ . /s - - - .additional file . interview guide for the semi-structured interviews with patients/family members and health professionals. key: cord- -qrnsmhws authors: rothman, richard e.; irvin, charlene b.; moran, gregory j.; sauer, lauren; bradshaw, ylisabyth s.; fry, robert b.; josephson, elaine b.; ledyard, holly k.; hirshon, jon mark title: respiratory hygiene in the emergency department date: - - journal: ann emerg med doi: . /j.annemergmed. . . sha: doc_id: cord_uid: qrnsmhws the emergency department (ed) is an essential component of the public health response plan for control of acute respiratory infectious threats. effective respiratory hygiene in the ed is imperative to limit the spread of dangerous respiratory pathogens, including influenza, severe acute respiratory syndrome, avian influenza, and bioterrorism agents, particularly given that these agents may not be immediately identifiable. sustaining effective respiratory control measures is especially challenging in the ed because of patient crowding, inadequate staffing and resources, and ever-increasing numbers of immunocompromised patients. threat of contagion exists not only for ed patients but also for visitors, health care workers, and inpatient populations. potential physical sites for respiratory disease transmission extend from out-of-hospital care, to triage, waiting room, ed treatment area, and the hospital at large. this article presents a summary of the most current information available in the literature about respiratory hygiene in the ed, including administrative, patient, and legal issues. wherever possible, specific recommendations and references to practical information from the centers for disease control and prevention are provided. the “administrative issues” section describes coordination with public health departments, procedures for effective facility planning, and measures for health care worker protection (education, staffing optimization, and vaccination). the patient care section addresses the potentially infected ed patient, including emergency medical services concerns, triage planning, and patient transport. “legal issues” discusses the interplay between public safety and patient privacy. emergency physicians play a critical role in early identification, treatment, and containment of potentially lethal respiratory pathogens. this brief synopsis should help clinicians and administrators understand, develop, and implement appropriate policies and procedures to address respiratory hygiene in the ed. respiratory tract infections are common presentations among emergency department (ed) patients, some of whom may present an infectious risk. unfortunately, definitive identification of the offending agent is generally not possible at the initial ed visit. potential respiratory agents that the st century emergency physician must consider include the traditional respiratory pathogens and also emerging (eg, severe acute respiratory syndrome [sars]), highly virulent (eg, avian influenza virus), resistant, and even bioterrorism-related agents. thus, within the ed there is a potentially dangerous mixture of infections with serious possible public health consequences. threat of contagion exists for uninfected patients (in the ed, the hospital at large, and the community) and health care personnel (including ed physicians). through implementation of the most up-to-date guidelines, health care personnel can aid in minimizing respiratory infection transmission and protect patients and other hospital personnel from infection. the potential risk for respiratory infection-related morbidity and mortality is compounded in the ed because of the increasing number of immunocompromised ed patients. populations at increased risk include organ transplant patients, hiv-infected patients, and postchemotherapy patients, all of whom are living longer because of improved lifesaving therapies. crowded and understaffed eds further elevate risk of contagion and possible public health disasters. two potentially lethal infections that are transmitted by the respiratory route, which most emergency physicians are familiar with, are neisseria meningitis (which causes meningococcemia) and mycobacterium tuberculosis. these agents are relatively uncommon, however, in most us eds, and as recently as , the centers for disease control and prevention (cdc) reported that health care facility environments are rarely implicated in respiratory pathogen transmission (except in cases of immunocompromised patients). case reports of transmission of sars among hospital workers from that year resulted in heightened awareness of the need for increased attention to respiratory precautions. for example, according to lau et al, % of sars cases ( / cases) at the prince of wales hospital in hong kong occurred in hospital workers who did not take special protective measures during the sars outbreak. another study found that failure of providers to recognize risk, implement strict isolation measures, and diagnose disease was responsible for the majority of nosocomial cases of sars in hong kong (with the vast majority of cases occurring among physicians and nurses). internationally, health care worker infection has proven to account for up to % of sars cases in canada and approximately % of cases in hong kong. , these findings provide compelling data that hospital workers are at significant risk of contracting respiratory infections and establish an imperative for initiating broad-scale infection control measures. the participation of emergency physicians and nurses is critical for effective responsiveness to respiratory threats in hospitals. ed personnel represent a critical link in the chain of communication and response, along the continuum from the community to the inpatient unit. policies should anticipate responses to the complex spectrum of possible respiratory illnesses, from highly transmissible and unexpected emerging global diseases such as sars to yearly influenza epidemics. lessons from the terrorist attacks on september , , and other recent disasters emphasize the importance of integrating the public health system with both medical and mental health services, with close attention to capacity management and surge planning. organizational systems thus require that disaster and public health planning at regional and state levels produce systems that integrate the ed (the likely focal point for patients with acute respiratory infections) with hospital and regional response plans and resources. , the purpose of this report is to summarize, from both the peer-reviewed literature and public health sources (eg, from the cdc), information most relevant to ed respiratory infection control. specific and current recommendations and guidelines are provided, along with evidence supporting specific respiratory infection control measures, when available. the review is divided into sections, addressing administrative, patientrelated, and legal issues, with some unavoidable overlap occurring. administrative topics include public health coordination, facility planning, and health care worker issues. the patient-related portion covers patient flow from out-ofhospital and triage to waiting room and ed treatment areas, with inclusion of a discussion of patient education and patient transport. the legal section summarizes federal and local laws pertinent to respiratory hygiene. because sars represents the most recent significant respiratory pathogenic threat, many of the successes and challenges about respiratory infection control reference studies from the sars outbreak. while this research is sars specific, lessons that may be generalizable about infection control are provided. further, although an all-inclusive discussion about respiratory hygiene is impossible, this summary provides the most relevant and practical information for the practicing emergency physician, with specific references provided for particular topics to allow more detailed review. according to a recent national ed-based survey, acute respiratory infections are the leading ed "illness-related" diagnosis. another recent study from the pediatric literature reported that acute respiratory illnesses are the second leading category of adolescent diagnosis from ed visits among virtually every age group (except women aged to years). the significant influx of patients expected during an outbreak (such as sars or avian influenza) would result in an even greater proportion of ed patient visits for respiratory-related complaints. the cdc has developed several specific guidelines about infection control in hospitals, with the most recent updates issued in november . , the recommendations are graded according to levels of supporting evidence, as defined in figure . precautionary measures are divided into standard precautions ( figure ) to be followed in care of all patients and transmission-based precautions to be used in addition to standard precautions according to the route of pathogen transmission. transmission-based precautions include contact precautions for agents with potential transmission by direct or indirect contact; droplet precautions for agents with potential transmission by coughing, sneezing, talking, or performance of procedures ( figure ); and airborne precautions for agents with potential transmission by dissemination of either airborne droplet nuclei or evaporated droplets that remain suspended in the air for long periods (figure ). airborne transmission is relevant for small infectious particles that are m or smaller. administrative issues surrounding respiratory hygiene apply to the entire health care facility. emergency physicians should take a lead role in development and implementation of policies because the ed serves as the initial entry point for many patients. policies to address routine respiratory pathogens (eg, tuberculosis [tb] and influenza a), emerging pathogens (eg, sars or avian influenza), and bioterrorist agents are necessary. the cdc has provided detailed recommendations about health care facility response preparedness for a sars outbreak (available online at http://www.cdc.gov/ncidod/sars/guidance/ c/recommended.htm). although these may not all be generalized to every new respiratory threat, the principles described in the reference can guide institutional preparation for any large-scale respiratory pathogen threat. similar readiness plans for bioterrorism preparedness have been devised and published conjointly by the cdc and the association of professionals in infection control and epidemiology. all health care facilities should have policies and procedures in place for respiratory infection control practice with specific operational plans for handling a large influx of potentially infectious patients in the event of a significant outbreak. when patient influx exceeds institutional capacity, plans should designate alternative triage and treatment areas either outdoors or in other nearby large-capacity facilities. although plans may designate patient care areas that exceed hospital capacity, staffing issues may limit the ability to actually use these areas in category ia. strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies. category ib. strongly recommended for implementation and supported by certain experimental, clinical, or epidemiologic studies and a strong theoretic rationale. a real event. community isolation and treatment facilities may also be activated; a prototype for such a facility was developed by the cdc for sars. in general, community facilities will likely house and treat patients with milder disease, with the public health department coordinating these procedures and venues. community isolation facilities (eg, motels, hotels) should have rooms that are equipped with private bathrooms, as well as receptacles to dispose of soiled linen and contaminated waste. personnel who work at the facility should also have n- respirators available, as well as disposable gowns and gloves. in general, patients at these facilities will be expected to care for themselves. other hospital infection-control procedures may involve cohorting potentially infectious patients (if isolation beds are not available), as well as rapidly discharging appropriate inpatients and canceling elective procedures to alleviate strain on hospital resources. preemptive planning and knowledge of health care facility (and ed) resource availability are critical components of preparedness. lack of resource planning was cited as a significant factor that contributed to the spread of sars in southeast asia and toronto. unfortunately, few recent data exist describing the availability of isolation facilities in us eds. a study found that less than % of eds had negativepressure isolation rooms. in a recent press release from november , american college of emergency physicians leaders warned that there is an urgent need for increased ed and hospital planning, specifically citing lack of adequate surge capacity, isolation facilities, and staff to treat the large increase in the number of patients that may result from an influenza pandemic. depending on the circumstances of the outbreak, public health officials may recommend keeping suspected noncritical infectious patients at home. the cdc's guidelines for home isolation for sars and pandemic influenza serve as prototypes. , alternatively, specific health care facilities may be designated as referral centers for suspected cases. although the public health department will ultimately be responsible for coordinating implementation of these types of large-scale overcapacity plans, emergency physicians need to understand the types of options available. ed physician participation in policy development will be critical in providing practical guidance for ed patient care and operations. policies to support rapid identification of patients with suspected respiratory infections that have serious public health consequences (eg, sars, avian influenza) should include mechanisms for definitive diagnostic testing and immediate reporting to the local health department. the hospital laboratory should be advised to take appropriate precautions with specimens and coordinate specialized testing with local or state health department laboratories. in a suspected outbreak with potential epidemic risk, procedures for contact tracing must be instituted. effective communications mechanisms between eds and health departments are required to allow contact tracing of potentially exposed patients, visitors, and health care workers who live in the community. contact tracing involves either active or passive monitoring. active monitoring consists of direct public health contact (telephone or in person), for example, once a day for exposed persons to assess for symptoms and address any needs. passive monitoring relies on the affected person's contacting the health authorities if symptoms develop. methods of monitoring depend on the exposure risk and capacity of the public health infrastructure. regardless of the type of monitoring recommended, all individuals in contact with a potentially infectious person need to be advised of symptoms and what to do if symptoms develop. additionally, persons with high-risk exposures may require activity restrictions. although the public health department would be responsible for the contact tracing process, emergency physicians need to understand these basic principles because they will likely be called on to work closely with public health departments and provide information about persons who are infected or exposed while in the ed. telephone numbers for the local health department should be readily available in all eds. policies should include clear designations of specific persons within the hospital who are responsible for communication with public health officials (eg, hospital infection control officer) and dissemination of up-to-date information to health care staff (eg, hospital chief executive officer). policies need to include processes for initiating communication with key public health officials after hours and on weekends and guidance about when communication should be initiated. potential community contacts should be identified in advance and be capable of effectively communicating needs and concerns of the public. although proper patient care is the main priority within the ed, the burden of protecting uninfected individuals from communicable illnesses is critical for minimizing spread of disease and the influx of new cases. the "hierarchy of control technologies" consists of (in order of effectiveness) engineering controls, administrative and work practice controls, and use of personal protective equipment. consistent application of these principles demonstrated success in limiting tb resurgence more than a decade ago and, more recently, the spread of sars. understanding the hierarchy allows comprehensive planning, clear implementation, and appropriate local adaptations. the most effective practices from each category should be implemented according to characteristics of the responsible agent. for instances in which the infectious agent is unknown, the most restrictive isolation methods available should be instituted. emergency physicians' preparedness thus requires understanding of institutional resource availability and capacity and early initiation of infectious disease or public health consultation if a new outbreak is suspected or institutional capacity is at risk of being overwhelmed. problems with limited isolation resources in the ed or inpatient setting are usually best addressed in the short term by use of cohorting strategies. engineering controls provide passive protection for health care workers, visitors, and patients. measures include use of isolation rooms (including negative pressure), filtration devices, and physical separation (eg, closing doors or cohorting). negative pressure isolation systems prevent contaminated air from traveling to other areas of the ed or hospital, which is the most efficient method for early containment of infectious respiratory pathogens because airflow from either single rooms or small units can be controlled. however, when the organism load is extremely high, negative-pressure units may not be % effective, because they leave live pathogen in the air or on surfaces. [ ] [ ] [ ] [ ] increased efficacy can be realized by supplementing negative-pressure isolation systems with a high efficiency particulate air (hepa) filtration system. hepa filtration systems supplement negative-pressure systems, removing fungi and bacteria greater than . m from the atmosphere. these can be installed in ventilation ducts but are also available as portable units. addition of ultraviolet lights allows killing of spores and active organisms. all hepa filters must be properly installed and maintained according to the manufacturer's instructions to ensure satisfactory decontamination. , closing doors and cohorting of patients are recommended if no proper isolation room is available. such methods proved effective in hong kong in early , when sars patients were cohorted into separate observation wards, with no subsequent secondary transmission reported. , unfortunately, if not done properly, cohorting in open wards may contribute to increased infection, as was seen in the early toronto sars experience. thus, it should be recognized that although possibly beneficial as an adjunctive measure when resources are scarce, physical separation and cohorting do not guarantee protection. accordingly, health care workers should use proper infection controls when visiting patients in rooms, including droplet precautions and, if indicated, personal occupation droplet precautions (ib) are applied in addition to standard precautions for patients known or suspected to be infected with microorganisms transmitted by droplets (larger than m that can be generated during coughing, sneezing, talking, or the performance of procedures). in addition to wearing a mask as outlined under "standard precautions," wear a mask when working within feet of the patient. limit transport to essential purposes only. if transport is necessary, mask the patient if possible. airborne precautions (ib) are applied in addition to standard precautions for patients known or suspected to be infected with microorganisms transmitted by airborne droplet nuclei (evaporated droplets containing microorganisms that remain suspended in the air and that can be widely dispersed by air currents within a room or over a long distance). safety and health administration (osha)-approved respirators. administration of effective infection containment requires written policies and procedures and is the "second tier" in the hierarchy of infection control. operational policies should include explicit criteria for suspecting disease, restricting contact with patients suspected of having infection, controlling transport and high-risk procedures, quarantining of patients and contacts, contact tracing, implementing methods for disinfection, and monitoring of isolation procedures. procedural policies should address need for supplemental staff, education and training for health care workers, medical surveillance of exposed health care workers, and communication with public health officials and the general public. rapid implementation of these policies is the key to infection control in an outbreak scenario and proved critically important in controlling sars. although sars specific, the cdc's checklist for sars preparedness in health care facilities provides a prototype of the types of policies and procedures that should be considered in the event of any bioterrorism-related or emerging communicable respiratory outbreak. in the aftermath of an infectious outbreak, postevent analysis should be conducted to determine which management efforts were effective and which were not from the hospital's and community's perspective. representatives of all affected departments and organizations should be included, and appropriate revisions should be incorporated into policies. health care worker surveillance should also attend to posttraumatic stress assessment and treatment, as indicated. personal protective equipment, including gloves, gown, masks, and respirators, provides barrier protection, preventing skin and mucous membrane exposures. although these resources offer protection to individuals by reducing likelihood of direct contact, they are categorized as the third hierarchy level because they do not eliminate the pathogen and may have limited effectiveness because of problems such as variable health care worker adherence, potential for equipment failure, and inadequate equipment availability. the cdc-and oshaapproved personal air filtration systems are n masks and powered air-purifying respirators. n masks are simple and inexpensive but require individual fit-testing. powered airpurifying respirators offer the advantage of nearly universal fit but are far more expensive and cumbersome to use. both devices require medical evaluation and clearance for safe use. personal protective equipment should be used by all health care workers in outbreak settings when patients with potentially contagious respiratory infections are treated. proper education of health care workers about respiratory hygiene practice is critical for effective infection control. written policies and procedures for education and training of health care workers should be developed at the institutional level. education topics should include infection control precautions, criteria for suspecting disease at first contact and methods for restricting contact with patients suspected of having infection, limiting and controlling patient transport, and minimizing exposure during high-risk procedures. additional educational topics for ed providers and administrators include criteria and procedures for quarantining of contacts, protocols for disinfection and for monitoring isolation, and methods for maintaining medical surveillance of exposed health care workers. providing adequate hospital staffing is important in any disaster, and personnel issues particular to infectious disasters must be given consideration in developing hospital and ed plans. all health care facilities should have policies and procedures for mobilizing and reassigning staff to more critical areas in the event of a disaster. because health care staff may be reluctant to come to work if they believe they are at risk of contracting an infectious illness, it is critical that the facility planning measures be reviewed in advance, with contingencies and backups in place. health care workers (particularly those working in front-line ed settings) should also be given priority for receiving vaccines or prophylactic antimicrobials, when appropriate. offering additional incentives to staff to come to work may also be required in certain situations. infectious outbreaks create the additional problem that health care workers themselves may become ill. plans for respiratory outbreaks should include regular evaluation of health care workers for infectious signs or symptoms, criteria for removing health care workers from patient care, and criteria for quarantine (either at home or in the workplace). health care airborne infection isolation rooms (aiir) workers' desire for a workplace quarantine option was demonstrated during the sars outbreak, in which individuals did not want to subject family members to an increased risk of infection. although the cdc provides recommendations for influenza vaccination among health care workers, there are no uniform recommendations for health care worker vaccination for all potential respiratory pathogens. in light of this, the influenza recommendations not only serve to guide planning for annual influenza epidemics but also may provide a template for other vaccine-preventable pathogens. research has demonstrated that influenza vaccination of health care workers contributes to a substantial decrease in patient mortality, which has led some experts to call for mandatory vaccination of health care workers. the cdc provides specific recommendations about when to provide chemoprophylaxis for influenza, which may be used as a template and adapted to other pathogens when guidelines are developed for new and emerging pathogens for which vaccines are available. vaccinations plans for certain agents (eg, anthrax and smallpox) are controversial. currently, preexposure anthrax vaccine is not recommended for health care workers. after the terrorist attacks of , the us government developed a smallpox vaccination plan that included "formation of smallpox response teams" at each institution. emergency physician volunteers participated as critical members of the team. although controversy still exists in the emergency medicine community about these recommendations, they remain. because the threat of a true smallpox event remains low, however, routine vaccination for all health care workers for smallpox is not recommended by the advisory committee on immunization practice. facilities should create a priority list for employee smallpox vaccination in the event of an outbreak, and emergency staff should be included. concerns about the potential spread of respiratory pathogens begin at the point of entry into the health care system and continue to the inpatient setting. emergency physicians need to be aware of the potential for infection, illness, and transmissibility in a variety of potentially high-risk environments, including ( ) emergency medical services (ems) and triage settings (in which historical and clinical information may be limited and risk underestimated), ( ) during performance of "high-risk" invasive airway procedures, and ( ) during patient transport to the various inpatient units throughout the hospital. the cdc provides specific recommendations for ems transport of sars patients. although specific ems recommendations do not exist for each of the transmissible respiratory threats, the general principles outlined in the sars directives are applicable to the transport of any patient with a suspected serious and contagious life-threatening respiratory infection and include the following: ( ) potentially contagious patients should be transported with as few ems personnel as possible, ( ) family members should not be allowed to ride with patients in the ambulance, ( ) ems personnel traveling with a patient suspected of having infection should wear proper personal protective equipment, including isolation gown, double gloves, facemask, and n or higher-grade respirator (eg, n , , a powered air-purifying respirator), ( ) patients should wear a surgical mask if feasible and, if not, use tissues to cover their mouth or nose during coughing or sneezing; and ( ) patients should be transported in a vehicle that has separate ventilation systems and compartments for patient and driver, whenever possible. finally, advanced ed notification is advised to facilitate prearrival planning to limit exposure of other individuals. ems personal protective equipment should be handled as medical waste, and ems vehicles should be decontaminated before transporting another patient. the importance of implementing effective triage and edbased diagnostic strategies is underscored by experience with highly transmissible respiratory infections such as tb and sars. several hospital-and ed-based studies provide data that demonstrate that lack of either provider education or adherence to institutional guidelines or inadequate diagnostic evaluation of patients at risk results in increased risk of disease transmission. , , , , underscoring this is the findings from one epidemiologic outbreak of sars in toronto that found that % of new infections in the hospital occurred in health care workers, with the highest rates in those working in eds and icus. both the world health organization and the cdc provide general recommendations for handling of patients with suspected respiratory infections that include having triage staff adhere to proper hand hygiene procedures and donning face masks and eye protection. , if sars or tb is suspected, health care workers in eds should don an n- , , or respirator. the degree of vigilance that should be applied to screening for respiratory infections depends on the current risk level, with the most up-to-date regional risk information based on surveillance data provided on a cdc web site. , for example, there are basic risk levels that apply to sars: ( ) no current sars transmission anywhere in the world, ( ) active sars transmission in limited geographic areas, and ( ) sars transmission within the community in which one is practicing. in the absence of person-to-person transmission of sars worldwide, the goal of domestic surveillance is to maximize early detection of cases while minimizing unnecessary laboratory testing and social disruption. in the absence of known transmission worldwide, the overall likelihood that a person in the united states with fever and respiratory symptoms will have sars is exceedingly low. if sars transmission is present in limited geographic areas, screening should focus on identifying persons with possible geographic exposures. when person-toperson sars transmission is present in the community, everyone with fever or respiratory symptoms should be screened for sars. in an outbreak scenario (eg, sars, avian influenza, or tb), explicit written criteria should be provided to triage personnel to allow rapid isolation of patients who may be harboring a highly contagious infection. the cdc has issued specific screening tools to be used for rapid detection and isolation of possible sars patients, depending on the absence or presence of personto-person transmission in the world (figures and ) . various similar ed-based triage guidelines for specific agents (eg, tb, influenza and avian influenza) , , that include use of early radiography have been developed, and the cdc web site (available online at http://www.cdc.gov) should be consulted for the most up-to-date recommendations, as well as the current threat level of sars. from the ed perspective, development of decision guidelines may be based on the characteristics of the epidemic and may require development and modification in real time. an excellent example is provided by an ed in singapore, in which a triage tool, developed throughout a -year period, yielded a false-negative rate for sars case identification of . %. , the cdc recommends that tissues and masks be made readily available for all symptomatic patients who enter the ed or hospital doors (to cover their mouths and noses) and that sinks or handwashing stations be accessible for all patients in waiting rooms and triage areas. during periods of increased respiratory infections (eg, influenza season), separation of symptomatic and asymptomatic patients in waiting rooms and triage areas is advised, and surgical masks should be distributed to all patients with active respiratory symptoms. when it is not feasible to set up separate waiting areas in the ed, symptomatic patients should be encouraged to sit at least feet away from other patients in the waiting room. according to the cdc, this practice is supported by level ib evidence. the cdc recommends that visual education be provided at all patient entrances to eds during periods of heightened respiratory alert. visual alerts (including signs, pamphlets, and other general education measures about respiratory hygiene) are proven measures that can decrease disease transmission. it is recommended that visual alerts be present in several languages (depending on the region of the country and population served) and be provided at an appropriate reading level to allow for comprehension by the majority of the population. content of educational material should include a general description of standard respiratory hygiene methods, including handwashing, use of disposable tissues for covering mouth and nose, and staying at least feet away from persons with symptoms. although proper patient care is the main priority within the ed, protecting uninfected patients from communicable illnesses is also important. early isolation decreases the likelihood of person-to-person transmission. patients with a suspected but unidentified communicable respiratory infection should be placed in an environment with the highest level of protection available until definitive identification of the offending pathogen can be made or the possibility of a public health threat can be safely ruled out. laboratory diagnosis of respiratory contagious pathogens represents a critical step in decisionmaking about the need for isolation, treatment, and disposition. unfortunately, from the standpoint of the emergency physician, most current criterionstandard laboratory assays rely on serologic or culture methodologies often requiring days to weeks for definitive reporting. even when alternative nonculture-based methodologies are available (eg, acid-fast bacillus smear results for tb), reliable confirmation requires multiple sample procurement during a period of several days. for this reason, decisionmaking about patient care relies on clinical suspicion, which includes current knowledge of the community likelihood of a respiratory infectious event, risk status of the patient, and patient presenting signs and symptoms, which are often nonspecific. as described under "ed triage and waiting room," clinical guidelines may be used as well for assistance. rapid diagnostic assays for contagious respiratory pathogens hold great promise with regard to assisting ed physicians in treatment of patients with suspected respiratory contagious pathogens. although significant molecular advancements have recently been made in design and evaluation of rapid molecular-based methods, most notably using polymerase chain reaction techniques, few have reached the status of standard of care for point-of-care use. rapid diagnostic assays for influenza are available, but none has adequate sensitivity or specificity to allow recommendation for definitive care in ed settings. interventional airway procedures in the ed (including use of nebulized therapy and endotracheal intubation) increase risk for airborne transmission of disease because they result in release of high pathogen loads. although most procedures can be done in the ed, the us department of health and human services recommends that in outbreak settings, aerosol-generating procedures (eg, nebulized medications or bilevel positive air pressure) be avoided as much as possible. when essential for patient care, health care workers involved in these procedures should use n respirators or powered air-purifying respirators, along with gloves and gowns. after the procedure is completed, personal protective equipment should be removed and safely discarded to avoid contaminating the health care worker or the environment. specific detailed recommendations about intubation suggest that added measures be taken to reduce unnecessary exposure to health care workers, including reducing the number of health care workers present and adequately sedating or paralyzing the patient to reduce the possibility of a cough. all high-risk procedures should be performed only by highly experienced staff. it is recommended that patient transport and movement from the room be limited to essential purposes only. when transport out of the room occurs, masks should be worn by the patient to reduce the opportunity for transmission to patients and staff and reduce environmental contamination. further, health care workers in the area to which the patient is to be taken should be notified in advance. there is a forceful interplay between the health and wellbeing of the public in general and an individual's rights, which is set within a complex and often confusing legal field. this affects emergency practitioners and health care facilities concerning respiratory infections primarily in ways: ( ) through the need to notify appropriate public health authorities of reportable infectious diseases, and ( ) through the requirement to isolate ill patients and quarantine sick contacts. the cdc is recognized as the lead federal agency for protecting the health of the public and has various federal responsibilities in this regard, including investigations of unusual diseases and federal quarantine authority. according to title united states code section , the surgeon general, with the approval of the secretary, is authorized to make and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases. however, the current legal framework of public health oversight and response in the united states is a complex mix of state and federal laws. thus, the specific requirements for any practitioner, ed, or hospital vary according to the local and state laws. , the federal government has oversight of importation of infectious diseases and overall quarantine authority, but the individual states generally have the primary authority and responsibility of responding to public health problems within their jurisdiction, such as investigating a cluster of tb cases and isolating infectious individuals. states also have the responsibility of addressing their own public health emergencies. the interface between law, medicine, and public health requires the balancing of many potentially competing interests, especially individual human rights versus the need to protect the public's health. there is significant background and legal precedent on this topic. it is best for institutions to have an existing relationship with local or state public health officials to ensure ongoing bidirectional communication in times of urgency or emergency. as in any emergency, adequate preparedness, coupled with clear communication, allows for coordinated response. the list of reportable diseases is established by each state or territory, though the cdc has recommended specific case definitions for infectious conditions that could fall under public health surveillance. timeliness and mechanism for reporting also vary for different diseases. for example, a case of smallpox requires an immediate telephone call, whereas cases of gonorrhea may be reported in a weekly written report. although this reporting activity may be mandated, it raises important legal and ethical issues about the balance between the duty to report and an individual's right to privacy. the surgeon general is responsible for controlling, directing, and managing all united states quarantine stations, which includes isolation for people who are ill and quarantine for people exposed but not ill. in april , sars was added to the list of diseases for which quarantine is authorized (other diseases included are cholera, diphtheria, tb, plague, smallpox, yellow fever, and viral hemorrhagic fever). a lesson from sars quarantines in singapore is the capacity of a highly contagious infection to cause a rapid pandemic. the implications of quarantining a population or individuals for the length of the incubation time (or the length of the illness if patient is infected) are numerous. quarantining a large population involves significant commitment of resources. to overcome the legal obstacles of a major quarantine, a plan must be in place well in advance of an outbreak. as part of the public health infrastructure, ed health care workers may be called on to participate in various infection containment strategies, including quarantining of individuals or vaccinating large segments of the population. one other important legal aspect relates to occupational safety. osha has a number of rules and regulations designed to protect the health and safety of health care workers. osha's jurisdiction includes all health care facilities. health care workers in eds should be aware that rules and regulations related to respiratory hygiene are legally mandated and must be implemented in hospitals in accordance with current guidelines, as described elsewhere. the increasing likelihood that a highly contagious respiratory outbreak such as pandemic influenza will be seen soon, coupled with recognition of the presence of significant gaps between experimental and theoretic advances in both technologic and methodologic approaches to infection control (versus true ed preparedness), has created the need for further research. rapid point-of-care diagnostics hold great potential for improving triage, treatment, and disposition planning. future research will need to bridge the divide between the numerous point-of-care assays that are under development and the need to have a reliable, easy-to-use test that is adequately sensitive and specific for clinical decisionmaking. although such development will likely take several years of investigation, such diagnostics in early phases of development include a polymerase chain reaction-based respiratory pathogen panel and a mass spectrophotometry platform that can rapidly evaluate polymerase chain reaction products to identify any potential new emerging threat. there are also multiple practical issues related to ed evaluation requiring study, including development of more effective clinical decision guidelines for isolation and diagnosis and determination of the impact and best practice methods for care in ambient settings. the effectiveness of ed air filtration techniques also remains unclear, and educational research in this area is required. the numerous ethical, legal, and practical challenges associated with isolation and quarantining of patients will also require further study, with emphasis on ed-specific questions such as the role of eds in care of "routine" emergencies, development of ed surge capacity, and optimization of methods for coordination of eds with the public health sector. one other area of research that is gaining increased attention and has particular relevance for eds involves surveillance methods for tracking respiratory illnesses. current approaches that involve ed-based researchers include syndromic surveillance based on ed complaints, evaluation of the efficacy of increased diagnostic testing in eds, and tracking of ed prescriptions. these new areas of research will likely grow rapidly as the threat of respiratory infections becomes more prevalent. this review serves as a brief synopsis of the issues surrounding respiratory hygiene as they relate to the ed. protecting patients and staff is a difficult task in the ed because cases of contagious respiratory infections are often not immediately identifiable. this report focuses on the development of appropriate policies relating to patients with potential transmissible respiratory pathogens. education of key individuals, along with rapid dissemination of accurate information, is necessary to support these policies and will be instrumental in ensuring effective implementation. emergency physicians will continue to be pivotal in the development of these policies by maintaining active administrative and leadership positions in hospitals, and advancing understanding of the critical role 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after the sars outbreak updated interim influenza vaccination recommendations: - influenza season effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial requiring influenza vaccination for health care workers: seven truths we must accept infection control guidance for the prevention and control of influenza in acute-care facilities emergency physicians' perspectives on smallpox vaccination advisory committee on immunization practices (acip) statement on smallpox preparedness and vaccination interim guidance: ground emergency medical transport for severe acute respiratory syndrome patients toronto emergency medical services and sars emerg infect dis delayed recognition and infection control for tuberculosis patients in the emergency department public health guidance for community-level preparedness and response to severe acute respiratory syndrome (sars), version , supplement i, section iii: infection control in healthcare facilities world health organization. hospital infection control guidance for severe acute respiratory syndrome (sars) sars in hospital emergency room respiratory and enteric viruses branch. surveillance summaries and additional information in the absence of sars transmission worldwide: guidance for surveillance, clinical and laboratory evaluation, and reporting, version evolution of an emergency department screening questionnaire for severe acute respiratory syndrome crash course in decision making performance characteristics of clinical diagnosis, a clinical decision rule, and a rapid influenza test in the detection of influenza infection in a community sample of adults cluster of severe acute respiratory syndrome cases among protected health-care workers: toronto, canada hhs pandemic influenza plan: supplement : infection control: personal protective equipment for special circumstances supplement infection control. part iv.d. occupational health issues guideline for isolation precautions in hospitals, part ii: recommendations for isolation precautions in hospitals center for law and the public's health at johns hopkins and georgetown universities. core legal competencies for public health professionals provider disease list and reporting instructions centers for disease control and prevention. case definitions for infectious conditions under public health surveillance public health law and ethics: a reader (california, milbank books on health and the public, ) diagnostic system for rapid and sensitive differential detection of pathogens rapid identification and strain-typing of respiratory pathogens for epidemic surveillance the frontlines of medicine project progress report: standardized communication of emergency department triage data for syndromic surveillance pcr-based diagnostics for infectious diseases: uses, limitations, and future applications in acute-care settings syndromic surveillance using emergency department data the acep public health committee is grateful to ms. margaret montgomery and ms. julie dill for their time and assistance in preparation of this manuscript. key: cord- - tcikxl authors: paul, elisabeth; brown, garrett w; ridde, valery title: covid- : time for paradigm shift in the nexus between local, national and global health date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: tcikxl nan ► the covid- pandemic has triggered unprecedented measures worldwide, which have often been adopted in an 'emergency' mode and are largely reactionary ► alternatively, covid- needs to be appraised as part of a much bigger health picture, adopting a "systems approach" that enables interactions with other acknowledged and preventable health conditions, which often receive disproportionately low attention ► to do so requires a paradigm shift in global health governance, from a specific reactional paradigm to a systemic, coordinated and preventive paradigm ► it is necessary to adopt a holistic approach to health reflecting both a security approach and a health development approach, tackling upstream causes and determinants, aimed at helping populations reduce their individual risk factors and augment their natural immunity ► such preventive health policies must be tailored to local specificities and local environments, and health systems must be strengthened at the local level so as to be able to respond to population needs and expectations ► the current crisis calls for a paradigm shift in public and global health policies; and in the in the nexus between local, national and global health policies and systems the who declared the novel coronavirus disease (covid- ) an 'emergency of international concern' on january and a pandemic on march. according to who's situation report - , as of april , the epidemic has caused deaths worldwide. while it is seemingly nearing its end in china, where it was first reported, it is still on the rise in europe, in the usa and in other parts of the world, including in many low-income and middle-income countries (lmics). the pandemic has triggered unprecedented measures worldwide. many countries have installed travel bans, confinement and lockdown policies. these responses have been adopted in an 'emergency' mode, and are largely reactionary, aimed at mitigating the spread of the disease while waiting for a specific cure and/or vaccine to be developed. here we do not want to underestimate the risks caused by the pandemic, nor to question the measures taken by the who and governments. but we would like to express our concerns regarding four covid- -related issues, and advocate for a 'paradigm shift'that is, a scientific revolution encompassing changes in the basic concepts and experimental practices of a scientific discipline -to prepare for future crises. a shift in focus: covid- in the broader global health picture it is important to remember other acknowledged and preventable health conditions, when compared with the focus that covid- has triggered at global and national levels. respiratory diseases have been leading causes of death and disability in the world before covid- . it is estimated that, globally, four million people die prematurely from chronic respiratory disease each year; in particular, one million die annually from chronic obstructive pulmonary disease; pneumonia kills millions of people annually and is a leading cause of death among children under years old; each year . million die from tuberculosis; and lung cancer kills . million people a year and is the deadliest cancer. the who estimates that seasonal influenza kills up to people a year. in , an estimated people died of malaria. in , about women died during and following pregnancy and childbirth-that is approximately women each day. in the usa alone, a lower limit of bmj global health deaths per year was associated with preventable harm in hospitals. whereas infectious diseases seem to inspire the most terror among the public and policymakers, noncommunicable diseases are responsible for almost % of all deaths. depression affects million people globally and is the leading cause of disability worldwide, and nearly people die from suicide every year. the global boom in premature mortality and morbidity from non-communicable diseases has now reached a point where some have even suggested it to be a pandemic. moreover, climate change (through increased heat waves and disasters) and atmospheric and environmental pollution are expected to increase deaths and injuries, especially in lmics. in some debates, climate change has become more than a risk factor, with increasing calls for the who to declare it a public health emergency. from a public health perspective, covid- needs to be appraised as part of a much bigger health picture. for instance, beyond the lethality and direct mortality rates of covid- , attention should be paid to the interaction with other pathogens, as well as to the more indirect effects of its mitigation measures. indeed, the pandemic and its containment measures interact with, and impact on, other health conditions and will have system-wide effects, highlighting the importance of adopting a 'systems approach' to its resolution. a paradigm shift in global health governance the global health community, national security agencies and all governments have known that a pandemic like covid- was likely to come, yet global health policy has remained woefully unprepared nor fit-for-purpose. in , the g members proclaimed that ebola had been a 'wake-up call' for the need for better global cooperation. it was also recognised that antimicrobial resistance (amr) threatened to kill million people by , thus demanding urgent action. yet little has been done to address these existing global health governance shortcomings. for example, the lauded g and g response, the global health security agenda (https:// ghsagenda. org/), continues to speak in the terms of costly 'countermeasures' versus prevention and health system strengthening. moreover, the pandemic emergency financing facility (pef) (https://www. worldbank. org/ en/ topic/ pandemics/ brief/ pandemic-emergency-financingfacility), meant to deliver up to $ million in epidemic assistance to curb expansion into a pandemic, sits idle as a complicated 'loan mechanism' at the world bank, available to only a few countries (eg, china and india do not qualify for the money). there is also serious ambiguity about how the pef intersects and/or complements the who's contingency fund for emergencies (cfe) (https://www. who. int/ emergencies/ funding/ contingency-fund-for-emergencies). the cfe is available to more countries for more risks, and more quickly, but represents far less money than the pef (which, in theory, should come after the cfe, if you happen to prequalify for the loan). the 'one health' approach, which was meant to offer a more responsive research and policy agenda to combat zoonotic diseases, remains sluggish at best and underdeveloped in terms of including environmental factors, such as soil and water, which play a crucial part in amr and other threats. in terms of pathogen monitoring and response, the international health regulations, which are meant 'to help the international community and governments prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide', are not fully implemented by many countries due to limited financial resources and political will, and have been violated in response to the covid- outbreak. what is more confounding is that many highincome countries like france have failed to fully implement the international health regulations, particularly in their overseas territories. in addition, other disease control mechanisms, like the who global influenza surveillance and response system (https://www. who. int/ influenza/ gisrs_ laboratory/ en/), remain inadequate and underfunded, with too few who laboratories and a market-based model where a global public good (pooled influenza knowledge) is turned into a private good (pharmaceutical profit), with historical inequities in terms of public health. moreover, many countries, like china, are incentivised not to raise the epidemic alarm too soon due to fears of diminished direct foreign investment (like with severe acute respiratory syndrome, h n and now covid- ) and fears that the government will be perceived as weak. these conditions of incapacity at the international level are exacerbated by a weakened who, whose budget has been radically reduced and ring-fenced. for example, the who used to receive three-quarters of its financing from assessed contributions levied on members. however, a change to a zero real growth policy for its regular budget in the s has meant it now only receives a quarter of its budget from member contributions. as a result, the who is dependent on extra-budgetary ring-fenced 'pet project' funding from donors to fill an increasingly shrinking budget. as the money flows to other multilateral health initiatives, the who's authority dissipates, with numerous organisations like the institute for health metrics and evaluation, the bill and melinda gates foundation and médecins sans frontières able to command greater epistemic authority, financial influence and response effectiveness. however, this expansion of initiatives creates a condition of policy fragmentation, which significantly weakens coordinated global public health. one real result of fragmentation of global health governance is an inefficient division of labour, where hundreds of actors such as the who, global fund, president's emergency plan for aids relief, united nations programme on hiv and aids, united states agency bmj global health for international development, world bank, the gates foundation and the clinton foundation (to name only a few) produce parallel programmes or bric-à-brac vertical health silos that have neither generated overall system strengthening in high burden countries nor allowed for effective global health policy. this creates two failures. first, contrary to sector-wide approaches, vertical 'pet-project' global initiatives often fail to promote sustainable long-term local health system strengthening, which is the best preventive defence for disease control (of all types, not just infectious diseases). second, the global level is woefully unprepared for epidemics, since global policy has remained reactionary, symptom-based and dependent on vaccine discoveries without full appreciation of other upstream determinants of disease and access to those vaccines. given the state of global health governance and inadequate investments in health system strengthening-as well as the failure, by many actors, to adopt a 'systems approach' to problem resolution -the spread and danger of covid- is not surprising. what is required, we argue, is to shift global health policymaking from a specific reactional paradigm to a systemic, holistic and preventive paradigm. there is no doubt that this approach will require serious resources, governance reform and political will. nevertheless, the global economic costs of covid- have already reached into at least a trillion dollars. thus, serious efforts to improve global and local health systems would be a small fraction of this cost, with a tried and true cost-saving philosophy that 'an ounce of prevention is worth a pound of cure'. beyond the 'pasteurian paradigm': a holistic view of health the emergency responses to covid- so far are based on the so-called 'pasteurian paradigm', which states that each disease is due to one pathogen; thus, for each disease there is one cure, targeting the responsible pathogen. in this case, laboratories are racing to find the cure or the vaccine against covid- -a vaccine which will come too late for the current epidemic, and will have limited efficacy if the virus mutates in the coming months or years. yet it is easy to see how the more pathogens there might be in the future (which there will be) the less this paradigm makes sense. moreover, the pasteurian paradigm has imposed its preferred research methodnamely, randomised control trials that try to isolate one variable from all possible variables-as the gold standard of science, relegating other approaches as near charlatanism. however, there is a multitude of evidence indicating that beyond a single pathogen, the development of a disease, as well as its outcome, is considerably affected by the physical and social parameters in which it operates, and that this is considerably affected by social, political, environmental and individual factors. this seems widely known by the public as far as chronic non-communicable diseases are concerned, but is also the case for infectious diseases, especially for emerging infections, in which the pathogenic role of social inequalities is recognised. moreover, the traditional frontiers between communicable and non-communicable diseases are being blurred by evidence of 'biosocial contagion'. in this light, the globalised world is now facing a 'syndemic'-that is, a synergy of epidemics that 'co occur in time and place, interact with each other to produce complex sequelae, and share common underlying societal drivers'. covid- is no exception, since its mortality rate varies significantly according to age, sex and comorbidities. as an alternative, we argue that it would be more effective, efficient and equitable to adopt a holistic approach to health. how to tackle the silent killers and how to prepare populations-including the most vulnerable -against future epidemics should be on the top of national and global health policy and research agendas. this should reflect both a security approach (fighting symptomatic issues) and a health development approach (tackling upstream causes and determinants). in doing so, the objectives should not be merely be the response mode, but a more concerted effort to limit environmental factors, protect biodiversity, reduce social health inequities, strengthen local health systems for preventive health, help populations reduce their individual risk factors and augment their natural immunity-notably through various 'healthy behaviours' and diets that are proven to strengthen the general immune system. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] like what recently took place in the field of evaluation of complex systems and policies, a 'realist' revolution of medical research is probably needed to help support this. it is ultimately important that the resulting policies are not copy-pasted from other countries, but adapted to each context, and backed by strong local health systems. by definition, preventive health policies must be tailored to local specificities, including local environments, and health systems must be strengthened at the local level so as to be able to respond to a population's needs and expectations. this is also the case for the response to covid- . viruses and epidemics have always existed, and will always exist, and should be anticipated. coronaviruses are a well-known family of viruses, and even if this one is particularly aggressive, its genome has been rapidly identified. the difference with this epidemic which is causing the semicollapse of health systems is that it has revealed a profound lack of national prevention and preparedness. in response to the epidemic, the most hit countries so far have faced a lack of equipment and critical care beds. in the uk and france, as just two examples, decades of austerity policies and an obsession with evaluating health facilities based on technical efficiency (ie, minimising inputs and increasing outputs) have considerably decreased the capacity of health systems to respond to above-average frequentation. the covid- emergency responses of many states have revealed important inconsistencies. in many european countries, the authorities have adopted a one-sizefits-all policy and imposed the same measures everywhere. more worryingly, some governments-notably in africahave not performed their own adapted risk assessment before copy-pasting strategies from abroad. this is problematic, since it makes little sense to use a predictive model developed from a country where the median age is and translate it to a country with a median age of , without adjusting the parameters. in addition, current policies fail to account for regional or transborder contextual parameters, where either more stringent or relaxed measures could be more suitable depending on geographical determinants. the universal lockdown of a whole country may not be necessary when there are only one or two epidemic outbreaks separated by hundreds of miles, especially if containment is quick and determined. what we suggest, in order to be effective, is that policies should fit each context and be adaptive at the territorial or ecosystem level, versus being unreflectively and uniformly bounded by national jurisdictions. this is the best way to not impose measures that are too coercive, which may face legal constraints and may be counterproductive, eroding public trust and cooperation. in the post-covid- recovery phase, we hope the lessons learnt from local, national and global responses to this pandemic will foster support, by policymakers and by the public, for tailored policy responses that support stronger and more integrated local health systems. in summary, the current crisis calls for a paradigm shift in public and global health policies. we will not be prepared for the next epidemic unless we take bold steps. first, global health policies should not be designed on a response mode to case-by-case threats, but should adopt a systems approach that can support a holistic picture of global disease burdens, risks and health conditions, as well as better consider the system-wide effects of adopted measures. second, countering current fragmentation in global health governance will require a substantial shift in global health policymaking from a reactional paradigm to a systemic and preventive paradigm, with meaningful commitments to human health security. third, there is a need to shift our focus from short-term curative policies based on the pasteurian paradigm, to long-term preventive and promotional policies based on a holistic view of people's health, which notably implies limiting environmental factors, reducing social health inequities, helping populations reduce their individual risk factors and augmenting their natural immunity. lastly, such holistic, preventive policies must be adapted to local contexts and implemented through strong local health systems able to have the 'cushion' capacity to respond to emergencies. twitter valery ridde @valeryridde acknowledgements we thank seye abimbola for inviting us to submit this commentary and for giving us critical suggestions for improvement, and eric muraille for advising on references on immunity. contributors ep and gb both had an initial idea for this paper and joined forces to arrive to this joint paper. they wrote the first draft and vr contributed to improving it. all authors contributed to the development of ideas, commenting on drafts and approved the final version. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. competing interests ep and vr have conducted consultations for various international and donor agencies. gb and vr have received funding from several research funding agencies. however, this article has been written in total independence of these contracts. patient consent for publication not required. provenance and peer review commissioned; internally peer reviewed. world health organization. coronavirus disease (covid- ) situation report - world health organization the structure of scientific revolutions forum of international respiratory societies. the global impact of respiratory disease -second edition up to people die of respiratory diseases linked to seasonal flu each year world bank group and the united nations population division a new, evidence-based estimate of patient harms associated with hospital care world health organization. noncommunicable diseases time to deliver -report of 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infection realistic evaluation. london: sage the coming plague: newly emerging diseases in a world out of balance. farrar, straus and giroux global preparedness monitoring board. a world at risk: annual report on global preparedness for health emergencies world health organization (acting as the host organization for the global preparedness monitoring board) healthcare resource statistics -beds why a one-size-fits-all approach to covid- could have lethal consequences [internet]. the conversation covid- -the law and limits of quarantine us emergency legal responses to novel coronavirus: balancing public health and civil liberties key: cord- -jcueu xh authors: rauch, sheila a.m.; simon, naomi m.; rothbaum, barbara o. title: rising tide: responding to the mental health impact of the covid‐ pandemic date: - - journal: depress anxiety doi: . /da. sha: doc_id: cord_uid: jcueu xh now freely downloadable on the anxiety and depression association of america website (https://adaa.org/sites/default/files/phasedapproachtocovid‐ .ver . % ( ).pdf) is a framework for covid‐ mental health response (see table ). this framework of phased interventions and resources is intended to assist health systems and programs impacted by the pandemic to plan for how to address current mental health issues arising as well as to prepare and plan for the continued needs of their communities, patients, and staff. this article is protected by copyright. all rights reserved. is larger than previous pandemics and has resulted in more deaths than / (cdc, ) , there is much that the mental health field knows from military, disaster settings, and other types of trauma exposures that can help guide how we support our health professionals working in this extremely stressful environment (va/dod, ) . investments in efforts to support mental health and provide indicated prevention and intervention may decrease long-term risk for negative mental health outcomes, including for healthcare workers and other staff on the frontlines of the pandemic. many are predicting that the mental health impact will be grim. we agree that the mental health impact will be significant, but also feel confident that for most, the pandemic and its aftermath will be a significant stressor that people cope with in real time and even if highly distressed acutely, will eventually naturally recover and move on to a new normal and satisfying life. the mental health response must be measured and not overly emphasize a belief and expectation of an epidemic of unmanageable long-term negative mental health impacts. instead, while planning to address mental health needs that will arise, we should project hope and have confidence that most people will recover with time. data from the field of trauma and bereavement strongly support that resilience is the modal outcome even for severe challenges (bonanno et al., ; barbara olasov rothbaum, foa, riggs, murdock, & walsh, ) . nonetheless, a shortage of access to effective mental healthcare was already a problem prior to the pandemic and will worsen even if only a small percentage require intervention (thomas, ellis, konrad, holzer, & morrissey, ). as such, planning needs to consider efficient use of resources and possibly stepped care models to provide the most effective and least resource intensive course of care to respond adequately (richards et al., ; zatzick et al., ) . helping people cope acutely this article is protected by copyright. all rights reserved. while assuring access to those in need of higher levels of mental health intervention are critically important goals. while the evidence base for prevention intervention is less clear about optimal approaches, there are nonetheless many helpful strategies that may help reduce both short-and long-term distress, and their targets are guided by relevant clinical and research lessons learned over many years. key to any mental health response to the current pandemic or other extended potentially highly distressing and/or traumatic events is a response that simultaneously considers both timing (referred to as phase) and associated distress and/or functional impairment (referred to as level). as defined below, the framework includes three phases (initial, post, and longer-term) and three levels (system level, self-directed level, and mental health supported brief intervention). the phased approach to covid- mental health response (pac) now freely downloadable on the anxiety and depression association of america website (https://adaa.org/sites/default/files/phasedapproachtocovid- .ver . % ( ).pdf) is a framework for covid- mental health response (see table ). this framework of phased interventions and resources is intended to assist health systems and programs impacted by the pandemic to plan for how to address current mental health issues arising as well as to prepare and plan for the continued needs of their communities, patients, and staff. in addition, many of the resources presented may be used by healthcare professionals and others on the front lines of care, as well as anyone being significantly impacted by covid- as they see fit. the framework provides a model for response over time and across the wide range and severity of potential impact of the pandemic, including program design considerations and examples of evidence-guided resources when available. for specific areas where this article is protected by copyright. all rights reserved. previous resources were not freely available, select evidence informed brief interventions were created and are downloadable from the framework posting on the adaa website [mask desensitization (with colleagues from the university of chicago, emory university school of medicine, and new york university), selfdirected difficult experience exposure (created by the authors and dr. jeffrey cigrang) , and assessment protocol with brief intervention for a mh provider adapted from (rothbaum et al., ) . this proposed phased approach is intended to help guide efficient allocation of mental health resources to those most in need of assistance at the time that they need it at the level that they need it (e.g., self-directed versus brief intervention with some support versus traditional treatment sessions with a provider). appropriate allocation of expert mental health resources can assist the system in providing evidence based clinical care to those who need it. the initial phase includes the period of time while we are dealing with the ongoing stressor, such as the current covid- pandemic (see table ). this phase would end when the initial risk and impact has ended or reduced to a "new normal" or lower level of risk. the post phase includes the initial responses in the period after the acute exposure to risk and loss is complete and the following three months when expectations are that people impacted will be having various levels of emotional reactions and response (see table ). the long-term phase covers from three months after the individual's experience of impact and loss is over and into the future (see table ). for this pandemic, the phases will overlap for individuals depending on their roles and specific impacting traumatic exposures (traumatic loss of significant this article is protected by copyright. all rights reserved. others, exposure to death at work, etc.). further, grief responses generally occur on a longer timeline with current iterations of prolonged or complicated grief utilizing a or month minimum for diagnosis to account for broad individual, cultural and religious variability in usual acute grief and its evolution to more integrated forms of grief (e.g., for recent commentary and treatment approaches see (iglewicz et al., ; simon et al., ) . within each phase, there are different levels of response. the system supported level focuses on recommendations for leadership and organizations to put in place for those in the relevant phase (see table ). the self-directed level includes resources that individuals can work with on their own. these self-directed interventions are intended to be used based on either self-assessment of need or as an initial intervention for those with mild to moderate distress and/or functional impairment without imminent risk to self or others (see table ). finally, the mental health supported brief intervention level includes brief interventions provided with entry through primary care or mental health providers for those with a higher level of need or for whom self-directed approaches are not possible and/or effective (see table ). as basic principles across all phases and levels, systems and individuals engaging in mental health response are encouraged to: ) ensure basic needs for food, sleep, and lodging are met. for healthcare providers and staff this means management of risk of personal and family covid- infection such as ppe. ) find creative ways to safely enhance social connection and support. ) provide ongoing support for people as they would like-not a single shot. this article is protected by copyright. all rights reserved. them in the past that they can draw on again such as talking with friends and/or family, exercise, yoga, prayer, etc. and monitor or possibly reduce unhelpful coping such as the use of alcohol or other harmful strategies. ) create opportunities for people as they are interested and able to talk about difficult experiences. this can be helpful to process them, but avoid compelling people to tell their stories, especially in groups. let them share as they are ready and willing-be ready to listen but don't force the story. ) avoid group debriefing where everyone is forced to share and listen to details of death or traumatic events. this has shown iatrogenic effects in some studies of trauma and ptsd. other types of group support efforts, however, can be helpful to provide opportunity to build community, emotional support, psychoeducation and reminders about resources (even if virtual). ) provide information about accessible mental health resources for those who may need them. people undergoing stress most often need support from family and community for basic needs, safety, and emotional support. plans for mental health response in the coming months must focus on providing social support and helping people to feel in control of things they can control while focusing professional mental health resources on those who need it most. the framework offers some ideas about how to integrate a phased approach to helping support those on the front lines or anyone being significantly emotionally challenged by the covid- pandemic to meet our this article is protected by copyright. all rights reserved. community needs over time. empirical examination of the evidence informed new resources that are part of the framework will soon be underway and as we learn about needs and response overtime, this framework will be modified to address the best science available. resilience to loss and chronic grief: a prospective study from preloss to -months postloss moving effective treatment for posttraumatic stress disorder to primary care: a randomized controlled trial with active duty military corona virus disease (covid- ) cases date and surveilence complicated grief therapy for clinicians: an evidence-based protocol for mental health practice delivering stepped care: an analysis of implementation in routine practice a prospective examination of post-traumatic stress disorder in rape victims early intervention may prevent the development of posttraumatic stress disorder: a randomized pilot civilian study with modified prolonged exposure understanding and addressing sources of anxiety among health care professionals during the covid- commentary on evidence in support of a grief-related condition as a dsm diagnosis county-level estimates of mental health professional shortage in the united states this article is protected by copyright. all rights reserved reactions when they think about their experiences.in military service members to reduce ptsd symptoms when provided within the primary care environment with an embedded mental health provider as support (cigrang et al., (rothbaum, et al., ) . early intervention may prevent the development of posttraumatic stress disorder: a randomized pilot civilian study with modified prolonged exposure. settings. focus more closely over time on those with identified functional impairment over time evidence based care such as cbt, or pharmacotherapy when indicated guideline key: cord- -irpm g g authors: lee, bruce y. title: the role of internists during epidemics, outbreaks, and bioterrorist attacks date: - - journal: j gen intern med doi: . /s - - - sha: doc_id: cord_uid: irpm g g internists are well-positioned to play significant roles in recognizing and responding to epidemics, outbreaks, and bioterrorist attacks. they see large numbers of patients with various health problems and may be the patients’ only interaction with the medical community for symptoms resulting from infectious diseases and injuries from radiation, chemicals, and/or burns. therefore, internists must understand early warning signs of different bioterrorist and infectious agents, proper reporting channels and measures, various ways that they can assist the public health response, and roles of different local, state, and federal agencies. in addition, it is important to understand effects of a public health disaster on clinic operations and relevant legal consequences. during the past half decade, well-publicized events, including the anthrax mail attacks, hurricane katrina, and severe acute respiratory syndrome (sars) , have reminded us that epidemics, disease outbreaks, bioterrorist attacks, and natural disasters can occur. although there is debate over when and how they may happen, there is little question that such events could have significant and far-reaching health, social, and economic consequences. moreover, smaller outbreaks, such as influenza and west nile virus, occur with greater regularity. internists can play vital roles in identifying, responding to, and containing bioterrorist attacks and disease outbreaks if they understand their role in these events. internists may be among the first to recognize clues that a problem is occurring, especially as initial signs and symptoms may be subtle or mimic common disorders, prompting victims to contact their primary care physicians, rather than go to emergency departments. furthermore, internists' broad range of medical knowledge, experience, and skills make them uniquely qualified to diagnose and treat a variety of potential health problems. internists are also well-positioned to work with various health care personnel and services during a disaster. therefore, internists must understand early warning signs of bioterrorist and infectious agents, proper reporting channels and measures, and ways that they can help contain and treat the consequences of epidemics, outbreaks, and attacks. during its initial stages, an attack, epidemic, or outbreak may not be obvious. depending on the agent and its mode of transmission, the population density, and the population's access to health care, it can be days or even weeks before anyone can recognize the problem. as the early response may be crucial in containing the problem and minimizing resultant morbidity and mortality, efforts have been made to develop biosurveillance systems to detect outbreaks and attacks. [ ] [ ] [ ] these systems collect pertinent data (e.g., pharmacy drug sales, emergency department visit chief complaints, and air samples) and search for irregularities that suggest a problem is occurring. however, these systems are by no means foolproof because they only look for a finite set of clues, do not cover every part of the united states, and may provide equivocal information. moreover, there could be delays between the point that biosurveillance systems detect suspicious patterns and when the public health system responds. therefore, internists might be the first to become aware of a problem and pivotal in initiating the public health response. internists see large numbers of patients with various health problems and may be the patients' only interaction with the medical community for symptoms resulting from infectious diseases and injuries from radiation, chemicals, and/or burns. so they could be the first to report attacks or outbreaks and initiate public health response. indeed, there are examples of "astute" clinicians being the first to recognize epidemic or bioterrorist attacks (e.g., the new york city west nile outbreak, the anthrax attack cases, , and the sars epidemic in vietnam ). in some cases, bioterrorist and infectious agents cause distinctive signs and symptoms. , for example, of the inhalational anthrax cases in the attacks, all had fever, chills, lethargy, and chest x-ray abnormalities. seven had mediastinal widening, and had pleural effusions. all but had elevated liver transaminases. a combination of these findings is highly suspicious for inhalational anthrax, especially in a young, otherwise healthy patient and/or when a patient initially experiences nonspecific influenza-like symptoms followed first by a brief period of apparent recovery, and then, by an abrupt resurgence of more severe symptoms. however, in a majority of cases, early symptoms are vague and readily mistaken for more common upper respiratory infections (e.g., influenza, plague, tularemia, and staphylococcal enterotoxin b) or viral gastroenteritis (e.g., hepatitis a, cryptosporidium, and salmonella). therefore, in addition to looking for specific symptoms, internists should remain vigilant about general trends and patient flow in their clinics. any of the following may be the only sign that an attack or outbreak has occurred , and rabbits in tularemia outbreaks ); . physicians or other clinic staff becoming ill after coming into contact with patients (e.g., the sars epidemic ); . a patient's health rapidly deteriorates out of proportion to the presenting symptoms and diagnosis (e.g., a -yearold non-immunocompromised patient dying of pneumonia is rare); . an unusual number of patients fail to respond to treatments. an internist's index of suspicion should be even higher when bioterrorism or epidemic alerts are issued. internists must be prepared to address a wide range of physical, psychological, and social consequences of public health disasters. patients may be injured by either a public health disaster or the ensuing mass panic. in addition, internists may have to function as emergency physicians when emergency departments are overcrowded or unavailable. specifically, internists must be prepared to: . treat the exposed and infected. different organ systems can be affected (e.g., meningitis from inhalational anthrax, sepsis from typhoidal tularemia, and pneumonia from influenza), so complete examinations are important. websites providing extensive treatment and prophylaxis information include the center for disease control and prevention (cdc) (http://www.bt.cdc.gov/), food and drug administration (fda) (http://www.fda.gov/cder/drugprepare/default.htm), department of health and human services (http://www.hhs.gov/disasters/index.shtml), and national library of medicine (http://www.nlm.nih.gov/ medlineplus/biodefenseandbioterrorism.html); . administer prophylaxis to the exposed but not the infected. determining exposure can be difficult as patients may claim that they have been exposed. in a large-scale epidemic or attack, public health officials may set up temporary stations for mass vaccination and prophylaxis. however, many patients may still appear at clinics requesting prophylaxis; . triage who gets treated in a large outbreak/attack. internists will have to prioritize who should receive treatment, especially when necessary resources and skilled manpower are limited. knowing when and how to ration treatments can be challenging, particularly in chaotic conditions. although internists may feel compelled to acquiesce to every patient's needs, their primary responsibility in public health emergencies is the public. while clear guidelines have not been established and rationing decisions are rather controversial, certain groups such as essential personnel (e.g., health care workers, police, fire fighters, and other individuals integral in responding to a public health disaster) should receive priority. essential personnel are needed to prevent more casualties and fatalities and could spread contagious diseases to many other people; . treat mental health consequences. public health disasters can result in significantly increased mental health problems including anxiety, depression, and posttraumatic stress disorders. [ ] [ ] [ ] [ ] evidence suggests that even people who witness, hear, or read about a disaster can be affected. , shortages of mental health professionals in a disaster often require internists to handle patients' mental health issues. - . treat comorbidity exacerbations. evidence suggests that undue environmental stresses can exacerbate comorbidities such as heart disease and respiratory disease. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] in addition, during public health disasters, patients with certain chronic diseases (e.g., diabetes and chronic obstructive pulmonary diseases) may not have adequate access to maintenance treatments. proper reporting and the public health and law enforcement chain of command figure illustrates the public health chain of command. internists suspecting an attack or epidemic should immediately inform the local or state health department and contain any possible threat in their clinics, especially if the agent is contagious. providing information to wrong people (especially news media) may cause mass terror and delay the public health system's response. therefore, internists must remain calm, understand how their words can be misunderstood and misconstrued, follow instructions from appropriate health, military and law enforcement officials, and allow properly trained public health officials to deal with the media. local authorities are responsible for the initial response to any public health emergency with appropriate state agencies providing additional support when necessary. depending on the nature and magnitude of the problem, local or state authorities may choose to involve federal agencies. unlike naturally occurring disease outbreaks, bioterrorist attacks are criminal acts and require intervention of law enforcement agencies. when there is a risk of contagious disease transmission across state lines or state efforts are deemed inadequate, the federal government assumes authority. the president makes executive decisions. the cdc administers federal quarantine actions. implementation of order could involve the department of defense or the federal emergency management agency (fema). for travelers seeking to enter the united states, the cdc has the authority to enact quarantine. in areas where the cdc's division of global migration and quarantine personnel are not stationed, the immigration and naturalization service and the united states customs service personnel are trained to identify travelers with potential epidemic. it is essential that health care professionals adequately protect themselves. they are needed to care for both victims of an outbreak/attack and "regular" patients and can inadvertently spread communicable agents rather quickly, especially to vulnerable members of the population. , one study examined clinicians' knowledge regarding proper infection control practices during a bioterrorist event and found numerous deficiencies. standard precautions should be exercised for all situations. internists should wash their hands frequently and be careful when handling body tissues and fluids. certain diseases require additional precautions (table ) . contaminated clothing should be removed promptly and placed in sealed plastic bags. soap and warm water can wash off most noncontagious agents. , bleach is needed for chemical decontamination. any health care worker who receives a needle stick from a potentially bacteremic anthrax-infected patient should receive prophylactic antibiotics. although the words quarantine and isolation have been erroneously used interchangeably, quarantine means the separation and confinement of currently healthy people who may have been exposed to a contagious disease, while isolation refers to the separation and confinement of people known or suspected to be infected with the contagious disease. when an infectious disease is confined to a specific locale, the authority to order quarantines usually rests with local or state public health officials. when the event spreads across jurisdictional boundaries within the state, such authority usually is relin- quished to the state. there is great variability in quarantine regulations from state to state. clinic patient volume can increase significantly from ill patients and concerned healthy patients (the "worried well"). this "worried well" phenomenon was seen after the anthrax attacks. , internists will have to offer reassurance to the "worried well," relay appropriate disease information, and direct them to the right public health agencies and relevant websites (e.g., fig. and websites listed in "treatment and prophylaxis") for information and mass prophylaxis (if needed). clinics should minimize potentially contagious patients' contact with health care workers and other patients by either temporal segregation (clustering potentially contagious patients later in the day) or spatial segregation (shunting potentially contagious patients towards specific rooms). therefore, clinic schedulers and telephone operators should be aware of the signs and symptoms that suggest a patient is contagious. proper triaging is necessary. minor issues and complaints may have to wait, but urgent problems must be addressed. the clinic will not operate with normal efficiency. health care workers may become ill or be absent. running additional tests, notifying authorities, taking on and off personal protective equipment, rearranging the clinic, and decontaminating rooms will cause operational delays. clinics that routinely run at peak capacity could become overwhelmed, especially if the clinic staff themselves become ill. every clinic should have clearly established contingency plans and build an extra capacity that can handle unexpected surges in patients. specifically clinics will need: . additional rooms to place and examine patients. clinics should identify other patient areas (e.g., procedure, radiology, and operating rooms) that can be converted into examination rooms. rooms not normally used for patients (e.g., offices or conference rooms) may be utilized if they meet basic requirements for patients who do not require isolation. mobile clinics and hospitals may be available ; . additional health care professionals and staff. clinics should know where and how to reach additional personnel who are cross-trained to handle a wide range of responsibilities in an emergency; . diversion plans. when a clinic is overwhelmed, it must know when to close to additional patients and where to send them. anytime medical treatment is administered, legal concerns come into play. public health disasters are no exception. in a mass casualty setting, the ability to mount an adequate response may be hindered by the myriad of rules and regulations that govern the everyday practice of medicine. laws vary from state to state, so internists should be aware of their state's specific regulations. unfortunately, many states have not yet adequately addressed or clarified medico-legal issues and regulations in public health disasters. some of these include: . licensing and admitting privileges. internists willing to provide assistance may not be licensed in that state, have appropriate admitting privileges, or have the time or means to complete the necessary paperwork before administering treatment. some states (e.g., colorado) have introduced statutes that ease some regulatory barriers by providing protection to health care workers during a public health disaster, such as allowing physicians to administer care even though they are not licensed in that state; . malpractice liability. while states do have "good samaritan" laws that offer some legal protection to physicians who aid strangers in "good faith," the extent of these laws varies from state to state and currently do not cover all potential eventualities. "good samaritan laws" may not apply when treatment is administered against a patient's will. . maintaining patient confidentiality. bioterrorist attacks and epidemics require physicians to quickly transmit patient and case information to other health care personnel and appropriate authorities. while such communication is paramount, efforts should be made to maintain patient confidentiality and transmit only necessary information. at present, it is unclear how health insurance portability and accountability act (hipaa) regulations would affect the public health and health care system response. in a public health emergency, the hipaa privacy rule does allow disclosure of the following protected health information (phi): for treatment by health care providers; to avert a serious threat to health or safety; to public health authorities for public health purposes; to protect national security; to law enforcement under certain conditions; and for judicial or administrative proceedings. , however, during an emergency, misunderstandings of the privacy rule's requirements may hinder the flow of phi. as internists could play a vital role in epidemics, disease outbreaks, or bioterrorist attacks, they must be knowledgeable, equipped, and prepared. in an emergency, potential legal and administrative barriers should be eased. clinics should have appropriate contingency plans. although the risk of large-scale attacks and epidemics seems low, the risk of smaller epidemics and local public health emergencies is much higher. preparing for large events will help prepare for such smaller events. potential financial conflicts of interest: none disclosed. death due to bioterrorism-related inhalational anthrax: report of patients update on emerging infections: news from the centers for disease control and prevention. vibrio illness after hurricane katrina-multiple states but fast enough? responding to the epidemic of severe acute respiratory syndrome a major outbreak of severe acute 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jurisdictions key: cord- - lfjfvs authors: hanney, stephen r.; kanya, lucy; pokhrel, subhash; jones, teresa h.; boaz, annette title: how to strengthen a health research system: who’s review, whose literature and who is providing leadership? date: - - journal: health res policy syst doi: . /s - - - sha: doc_id: cord_uid: lfjfvs background: health research is important for the achievement of the sustainable development goals. however, there are many challenges facing health research, including securing sufficient funds, building capacity, producing research findings and using both local and global evidence, and avoiding waste. a who initiative addressed these challenges by developing a conceptual framework with four functions to guide the development of national health research systems. despite some progress, more is needed before health research systems can meet their full potential of improving health systems. the who regional office for europe commissioned an evidence synthesis of the systems-level literature. this opinion piece considers its findings before reflecting on the vast additional literature available on the range of specific health research system functions related to the various challenges. finally, it considers who should lead research system strengthening. main text: the evidence synthesis identifies two main approaches for strengthening national health research systems, namely implementing comprehensive and coherent strategies and participation in partnerships. the literature describing these approaches at the systems level also provides data on ways to strengthen each of the four functions of governance, securing financing, capacity-building, and production and use of research. countries effectively implementing strategies include england, ireland and rwanda, whereas west africa experienced effective partnerships. recommended policy approaches for system strengthening are context specific. the vast literature on each function and the ever-growing evidence-base are illustrated by considering papers in just one key journal, health research policy and systems, and analysing the contribution of two national studies. a review of the functions of the iranian system identifies over relevant and mostly national records; an analysis of the creation of the english national institute for health research describes the key leadership role played by the health department. furthermore, who is playing leadership roles in helping coordinate partnerships within and across health research systems that have been attempting to tackle the covid- crisis. conclusions: the evidence synthesis provides a firm basis for decision-making by policy-makers and research leaders looking to strengthen national health research systems within their own national context. it identifies five crucial policy approaches — conducting situation analysis, sustaining a comprehensive strategy, engaging stakeholders, evaluating impacts on health systems, and partnership participation. the vast and ever-growing additional literature could provide further perspectives, including on crucial leadership roles for health ministries. keywords: biomedical research, capacity-building, evidence-based practice, health ministries, health research systems, health services research, policy-making, priority-setting, research utilisation, sustainable development goals, translational medical research background interest in strengthening health research systems has intensified following increasing recognition of the importance of research in achieving key goals such as universal health coverage [ ] and the sustainable development goals (sdgs) [ ] . however, achieving progress in health research faces many challenges, including securing sufficient funds [ ] [ ] [ ] [ ] [ ] [ ] [ ] , building and retaining capacity [ , , [ ] [ ] [ ] [ ] [ ] , producing research findings, and using both local and global evidence [ , [ ] [ ] [ ] [ ] [ ] [ ] . chalmers and glasziou [ ] dramatically highlighted the extent of the challenges facing health research by claiming, in , that even where there was funding and capacity, up to % of all biomedical research was wasted because it asked the wrong questions, was poorly designed, or was either not published or poorly reported, with only about % of studies being published in full. many of these challenges have long been recognised and the adoption of a systems approach advocated. in , the bangkok declaration on health research for development promoted the importance of a systems approach, following consideration of how a health research system could "be integrated with a nation's health development plan" [ ] . it suggested that establishing and strengthening an effective health research system needed coherent and coordinated health research strategies [ ] . national strategies should have specific combinations of various health research system components, tailored to the country's circumstances. the who's knowledge for better health initiative involved further work on these issues [ , ] . the mexico statement on health research, issued in by a ministerial summit, called for nations to take actions to strengthen their national health research systems (nhrss). it was endorsed in by the fifty-eighth world health assembly in a resolution committing its member states to strengthening their nhrss as a pathway to improve their overall health system [ ] . as part of the initiative, pang et al. [ ] developed a conceptual framework to guide the analysis and strengthening of health research systems, including development of a health research strategy. while this can be used for planning, monitoring and evaluation of health research systems, it did not claim to provide a precise blueprint. the framework defined a health research system as "the people, institutions, and activities whose primary purpose in relation to research is to generate high-quality knowledge that can be used to promote, restore, and/or maintain the health status of populations; it should include the mechanisms adopted to encourage the utilization of research" [ ] . the framework indicates the range of constituent components and how they can best be brought together into a coherent system. it identified four main functions for an effective system, namely stewardship, financing, capacity-building (or creating and sustaining resources), and producing and using research [ ] . each function is defined by operational components and consists of one or more of a total of nine such components. since then, progress is evidenced by analyses of developments in individual countries, including the national institute for health research (nihr) in england [ ] [ ] [ ] , and in repeat surveys conducted in various who regions, including africa [ , , ] and the pan-american health organization (paho) [ ] . however, as reported by those surveys and other publications, many challenges remain. for example, in february a new analysis by the who global observatory on health r&d examined health research funding, concluding that "neglected diseases such as those on the who list of neglected tropical diseases remain very neglected in terms of r&d investments" [ ] . nevertheless, there are various initiatives underway, including in who's regional office for europe, which commissioned an evidence synthesis on the topic as part of its action plan to strengthen the use of evidence, information and research for policy-making in the who european region [ ] . the synthesis is published in the who region's health evidence network (hen) report series and consists of a scoping review addressing the question "what is the evidence on policies, interventions and tools for establishing and/or strengthening nhrss and their effectiveness?" [ ] . the evidence synthesis focuses on the systems level and so primarily includes publications taking a systems approach at either the national or multi-national level. not surprisingly, health research policy and systems (harps) is the single largest source of papers included in the hen report. these were papers directly identified in the review's search or papers included in the hen report to illustrate a key point because they had been cited in one of the who reports or other systems-level collations of papers included in the synthesis. while the system level papers did provide considerable data about each function, limited resources to conduct the scoping review meant that we had to exclude papers focusing solely on one specific function of a health research system or on just one field of health research. as acknowledged in the hen report's agenda for further research, there is a large number of publications (papers and grey literature) covering each function [ ] . therefore, reviewing all of these publications would be a major task but some exploration of the extent of the task, and the nature of such literature, could be informative. furthermore, additional papers are continuously emerging, including from the various initiatives that are ongoing or just underway, for example, the european health research network [ ] . the three sections of this paper sequentially address the question of how to strengthen a health research system by: . describing key points and conclusions from who's hen report. . illustrating the nature of the ever-widening literature available on each function, or component, of a health research system by examining two sources in particular. first, the full range of papers published in harps in the months up to february . second, the range of data gathered from publications or interviews that is included in detailed studies of the national health research systems in two countries -iran [ ] and england [ ] ; between them, these two papers also illustrate diverse aspects of the additional material that could be drawn upon. . considering a key question in the analysis of the current and future initiatives, namely who is going to steer the development of health research systems? here, information and insights from the hen about this sometimes-controversial issue, along with wider continuing analysis, are drawn on in the more flexible and speculative way that can be undertaken in an opinion piece compared to a formal evidence synthesis. who's review, whose literature and who is providing leadership? who's review the evidence synthesis described by the hen report [ ] starts by describing the importance of nhrss in helping to achieve universal health coverage [ ] and the sdgs [ ] . it goes on to analyse the challenges facing health research and describes how issues remain unresolved despite the development and application of a systems approach including who's framework for health research systems [ ] . many countries do not have comprehensive national health research policies or strategies that would facilitate the introduction of a systems approach. therefore, challenges remain around two key and overlapping sets of issues. first, how to develop a systems approach to maximise the benefits from the research resources availablethis can be a challenge even in high-income countries with considerable research funding. second, how best to strengthen each specific function and component of a health research system [ ] . the hen identifies two main systems-level approaches to strengthening nhrss. the first is comprehensive and coherent strategies, which can be contained in either policy documents, such as those from the english nihr [ ], the irish health research board (hrb) [ ] and the rwandan ministry of health [ ] , or in specific legislation as in the philippines [ ] . the second systems-level approach involves partnerships and multicountry initiatives, especially with international organisations. two initiatives from the west african health organization (waho) are particularly important examples [ , ] . here, the ministries of health of the west african member countries worked together in a joint initiative covering all the countries and with funding and expertise from a range of partners, including the council on health research for development (cohred), the canadian international research centre, the special programme for research and training in tropical diseases, and the wellcome trust. all who regions have seen multi-country activities by who and/or cohred to strengthen nhrss, including the repeat surveys that identify areas for action [ , , ] . then, broadly using the who framework as the structure [ ] , the hen identifies key points from systems-level literature on each of the four functions and nine components. the components of the stewardship and governance function include defining a vision, ethical review, research priority-setting, and appropriate monitoring and evaluation [ ] . consultation with health system stakeholders should enhance the relevance of the research priorities to the healthcare system, with examples of extensive priority-setting engagement activities sometimes being seen as a key aspect of building the nhrs as in brazil [ ] . evaluating the impact of research on policy and practice should help researchers to focus on achieving such impact and was therefore promoted in the world health report [ ] . securing finance can involve obtaining funding from sources within the country and from external donors or multi-national organisations [ ] . targets for research expenditure, such as the % of national health expenditure set by the commission on health research for development [ ] , can usefully be brought into health research system strategies as in rwanda [ ] . major health research strategies from countries within the european union can highlight the importance of european union funding as in france [ ] , ireland [ ] and malta [ ] . requests for funding can be more effective when linked to other parts of the overall strategy, including identified priorities that need supporting through donor funding [ ] and assessments of the benefits obtained from previous funding such as in england [ ] . capacity-building involves building, strengthening and sustaining the human and physical capacity to conduct, absorb and utilise health research [ ] . in , santoro et al. [ ] identified the generally low levels of research production in countries of the former soviet union and south-eastern europe and made recommendations for the sustained investment in training and career development of researchers, which should go beyond scholarships for training abroad and involve comprehensive strategies to ensure clear career structures. strategies such as that from inserm in france set out comprehensive plans for capacity-building [ ] and strategies in both england and south africa addressed priority gaps identified in the research capacity within the healthcare professions [ , ] . donors can play an important part in building capacity but, recognising the need to avoid donor domination, often do so through partnerships. these can take diverse forms ranging from multi-country initiatives, such as that by waho, which included an initiative focusing on the challenges of postconflict countries but was unable to meet all the needs [ ] , to accounts that focus on the partnership to address a broad range of capacity issues in a single country such as malawi [ ] , to partnerships between individual institutions. examples of the latter can feature particular challengesthe james cook university in australia worked with the atoifi adventist hospital in malaita, the most populous province of the solomon islands, to start establishing health research system capacity on the island using an inclusive, participatory approach [ ] . increasingly, there are also south-south partnerships, for example, an account of the panamanian health research system described how the country's first doctoral programme in biotechnology was established with support from acharya nagarjuna university in india [ ] . the rwandan strategy described plans to tackle the 'brain drain' through making the country an appealing place to conduct health research in terms of job requirements and providing opportunities for career advancement [ ] . the three mutually reinforcing components of the producing and using research function encourage the production of scientifically valid findings that are relevant for users and communicated to them in an effective manner [ ] . major research funding bodies increasingly seek to address the waste issues raised by chalmers and glasziou [ ] by working together in the ensuring value in research (evir) funders' collaboration and development forum. it issued a consensus statement committing the organisations signing it to "require robust research design, conduct and analysis" [ ] . the forum is convened by the english nihr, the netherlands organization for health research and development, and the patient-centered outcomes research institute (united states) with the active support of major research funding organisations from australia, ireland (hrb), italy, sweden and wales, plus the special programme for research and training in tropical diseases [ ] . the first waho intervention also worked to boost research publications, including by creating a regional peerreviewed, multilingual journal [ ] . how research is produced can increase the chance that the evidence will be used in the health system, for example, the english nihr strategy noted that leading medical centres with substantial funding to conduct translational research can act as "early adopters of new insights in technologies, techniques and treatments for improving health" [ ] . fostering the use of research requires specific knowledge translation and management approaches that draw on both locally produced and globally available evidence. various health research strategies promote the role of cochrane, including in england, where a unified knowledge management system to meet the needs of various stakeholders, including patients and their carers, involves funding both cochrane and a review centre focusing on the needs of the national health system [ ]. in ireland, the hrb strategy facilitated evidence-informed decisions through promoting access to the cochrane library and supporting training in conducting high-quality cochrane reviews [ ] . south africa cochrane featured as an important element in the nhrs [ ] . the rwandan strategy stated that "the government of rwanda is committed to using research findings to make evidencebased decisions that will improve health in rwanda" [ ] . it aimed to orientate various functions, including agenda-setting, monitoring and evaluation, and capacitybuilding, towards facilitating this challenging aim. the world health report highlighted various mechanisms that health research systems could adopt, including evipnet (evidence-informed policy network), to promote the use of research [ , ] . the review also considers the effectiveness of approaches to strengthening nhrss. several reviews identified the effectiveness of the comprehensive approach taken by professor dame sally davies in creating the english nhrs [ , , ] . the title of one analysis, 'nihr at : examples, themes, transformation', emphasises that the success of the nihr depended on a range of elements being brought together in one transformation [ , ] . one of the themes was the involvement of patients in decisions about research priorities and processes and, based on this, another recent analysis highlighted england and alberta (canada) as having health research systems that had made important progress [ ] . davies herself reflected on the success of the nihr and stated: "what we envisaged was integrating a health research system into the health care delivery system so that the two would become interdependent and synergistic" [ ] . who's regional office for africa drew on their series of surveys of the performance of countries in building nhrss and analysed the data from the and surveys using the nhrs barometer that they developed to score progress on a range of items linked to the list of nhrs functions [ , ] . in the survey, the rwandan system was identified as the best performing and it, along with the majority of systems, was reported to have further improved in the survey; by then, south africa was reported to have the best performance in africa. the surveys also illustrate how the multi-country approach makes a useful contribution to strengthening nhrss by helping to target action. furthermore, the waho interventions made some progress but, while the evaluations identified the importance of political will and leadership provided by waho's parent organisation of west african states, they also emphasised that building capacity for a whole nhrs is a significant task requiring commitment over the long-term [ , ] . the hen review collated a range of examples of tools for nhrs strengthening. these were identified from the systems level discussions of nhrs strategies and partnerships and/or the major reports calling for nhrs strengthening such as the world health report [ ] . the hen lists these in an annex [ ] . the discussion in the hen draws on the literature that was included to identify five key policies that those responsible for strengthening nhrss could consider [ ] , namely conduct context, or situational, analyses to inform strengthening activities [ , , , , [ ] [ ] [ ] , develop a comprehensive and coherent strategy [ , [ ] [ ] [ ] , engage stakeholders in the development and operation of the strategy [ , , , , , , , , [ ] [ ] [ ] [ ] [ ] , adopt monitoring and evaluation tools that focus on the objectives of the nhrs, including health improvement [ , , , , ] , and develop partnerships [ , , , , ] . examples of the evidence to support or illustrate each policy are given in table . in summary, therefore, this section shows that the who evidence synthesis, published as a hen report [ ] , provides a firm basis for decision-making by policy-makers and research leaders looking to strengthen the health research system in their country. it analyses, in turn, the individual functions and components within a system and identifies a series of tools that can be used for strengthening many of them. finally, this section highlights the five crucial policy approaches that the hen report suggests can be applied as appropriate to the context of the country (table ) . as noted above, the hen was a scoping review and focused on the literature at the systems level rather than on publications (papers and grey literature) related solely to specific functions, types or fields of research [ ] . therefore, there is scope for further work to incorporate an even wider range of publications than the included in the hen review [ ] . the discussion in the hen suggests that further research could usefully take the form of a series of reviews on the extensive literature on each of the nhrs functions or components, which could then be collated [ ] . just two of the many available sources illustrate the nature of the vast literature available on each function, or component, of a health research system and the way the literature on that, and the system level developments, is ever-widening. first, we can examine the papers published in harps, the specialist journal in the field of building nhrss. second, we can focus on two very different but detailed studies of individual nhrssone conducted for a phd thesis to show the year history of the development of all the functions in the iranian health research system [ ] and the other an interview-based study to understand the factors behind the creation of the nihr with its new strategy [ ] . in terms of further reviews of the literature on specific functions or components, harps would probably be a key source. in the summer of , an analysis by the retiring editors of the papers published in the journal from its inception in identified many papers that had been published on each of the functions or components of a health research system [ ] . while this editors' analysis was included in the hen review because it organised its discussion of the papers at the systems level, the individual papers in it were, in general, only included in the hen review if they, too, adopted a systems approach at the national or partnership level, or were also cited in a report such as the world health report [ ] . examples of such papers include viergever et al. on priority-setting [ ] , bates et al. on capacity-building [ ] , and lavis et al. on the support tools for evidence-informed policy-making [ ] . therefore, many additional papers related to specific functions (or fields) could be consulted, in a formal review or otherwise, in any future series of reviews, each with a narrow focus on strengthening a specific function. to further inform this current opinion piece, a quick 'hand-search' was conducted of the papers published in harps in the months since the previous analysis in mid- [ ] . this again identified a wide range of papers on specific components, especially priority-setting, evaluation of research impacts, capacity-building and the translation of research (or knowledge mobilisation). various papers linked the final two points and discussed capacity-building and knowledge translation [ , ] . such a focus is entirely consistent with the aim described by the incoming editors in autumn of bringing "all elements of the research-policy world togethersuch that the research which is done is useful and that it is used" [ ] . in this more recent phase of harps, there have also been important papers on issues related to the policies 'recommended' at the end of the hen and listed above, including the contribution of stakeholder engagement in research [ ] . the more recent papers could sometimes provide useful further tools on specific functions. their narrow focus meant they had not been directly included through the hen search and, further, they had not been included in any of the major reports also used as sources for tools such as the world health report [ ] . in some instances, this was because they were too recent, for example, the isria statement by adam et al. [ ] describing the ten-point guidelines for an effective process of research impact assessment prepared by the international school on research impact assessment (isria). even more recently, the intervention scalability assessment tool, developed by milat et al. [ ] , was proposed for use not only by health policy-makers and practitioners for selecting interventions to scale up but also to help design research to fill evidence gaps. this analysis of the papers from just one journal reinforces the message that there is likely to be a plentiful supply of literature for a future review on any of the main specific components. this message is further reinforced by a more detailed analysis of the papers in harps in the first months of . articles on the main components of a nhrs were supplemented by some important papers on topics that are highly relevant but which feature less frequently in harps. these include a study aimed at reducing the research waste that arises from disproportionate regulation by examining the practices for exempting low-risk research from ethics review in four high-income countries [ ] , the global observatory's paper on research funding described earlier [ ] , a study on the governance of national health research funding institutions [ ] , and one on a more recent topic of growing significancean analysis of attempts to boost gender equality in health research [ ] . additionally, some of the papers on specific components, such as impact evaluation or use of evidence, are extending the analysis. examples include consideration of how research impact assessments are conduct context or situational analyses of current national position to inform strengthening activities cohred, in particular, has developed tools to assist countries in conducting situational analyses as part of wider advice [ ] and this approach was an important element in the waho interventions being successful to the extent that they were [ , , , ] . strategies informed by analyses of their current situation include those for the english nihr [ ] and the irish hrb [ ] develop a comprehensive and coherent nhrs strategy comprehensive and coherent strategies with at least some degree of success (as seen in progress on some or all of the nihr functions) had set out how they intended to take action on the range of health research system functions and components, even if not necessarily explicitly using the who framework [ ] ; examples include the strategies for the english nihr [ ], the irish hrb [ ] , and in the philippines [ ] and rwanda [ ] engage stakeholders in the development and operation of the nhrs strategy strategy documents such as those for the nihr [ ] and hrb [ ] , plus ones in british columbia [ ] , malta [ ] and new zealand [ ] , describe the importance and/or range of stakeholders engaged in developing the strategy. articles describing the approach in south africa [ ] and zambia [ ] also highlighted the importance of wide stakeholder engagement. an analysis of stakeholder engagement in the creation and operation of the nihr identified it as making a key contribution to its success [ ] . there is increasing support for the engagement of stakeholders in setting the priorities for research as well as in research processes and translation [ , , , , ] adopt monitoring and evaluation tools that focus on the objectives of the nhrs, including health system improvement a range of documents, including ones on the nihr [ ] , hrb [ ] and rwandan strategies [ ] , and the world health report [ ] , demonstrate the importance of adopting monitoring and evaluation approaches that include a focus on assessing the impacts of research on health polices/practice and the economy, e.g. through application of the payback framework [ , ] develop/participate in partnerships across regions, bilaterally or within the nhrs examples of progress made by partnerships between countries, sometimes along with international organisations and donors, include the waho interventions [ , , , ] and the work of who regional offices for africa [ , ] implemented in practice within research organisations [ ] and how evidence is used in decision-making in crisis zones [ ] . to illustrate the volume of studies being produced, there has been a flurry of studies, in the first months of alone, on the collaboration and coproduction of health research. the titles include 'building an integrated knowledge translation (ikt) evidence base: colloquium proceedings and research direction' [ ] , 'using a 'rich picture' to facilitate systems thinking in research coproduction' [ ] , 'exploring the evolution of engagement between academic public health researchers and decision-makers: from initiation to dissolution' [ ] , 'research co-design in health: a rapid overview of reviews' [ ] , and 'conceptualising the initiation of researcher and research user partnerships: a metanarrative review' [ ] . finally, another article in may presented a new conceptual model for health research systems to strengthen health inequalities research [ ] . here, we have focused on just one journal, harps, because it was the largest single source of papers in the hen report, which totalled publications (additional publications were included to the in the review to help set the background, provide examples of key tools, etc). however, even with the review's focus on the system level, harps only provided % ( out of ) of the publications; % ( of ) came from other journals and % ( of ) were other types of publication. if the focus was shifted to including papers on specific functions it is highly likely that there would be a higher proportion of papers from other journals. the authors of two single-country papers on the development of the health research system, mansoori [ ] about iran and atkinson et al. [ ] on the creation of the nihr in england, both highlight the importance of context but also claim their findings could have wider application. examining these two papers is also informative because of the differences between the studies, including one being located in a low-or middle-income country, and the other not. mansoori's narrative review of studies addressing the health research system of iran included relevant and mostly national records, categorised using an approach informed by the functions and components of who's nhrs framework [ ] . the papers and grey literature documents included were all available in english or persian, and mostly published in journals other than harps, and illustrate the vast literature available at a global level on the various components of a nhrs. they informed an impressively detailed account of the various nhrs components and the attempts to strengthen them. for example, the account of the development of the national level ethical overview includes a fully documented chronology of the progress over years and some insightful analysis of how the progress was facilitated by the pivotal role of professor bagher larijani, who was a prominent medical practitioner, leading researcher and founder of the medical ethics research centre in iran. he was able to "use the confidence that iranian authorities had in him as an opportunity" [ ] . while mansoori's review was included in the hen review, only a tiny fraction of the available data about iran could be included, primarily in a brief description of the system's effectiveness [ ] . however, the full paper could usefully inform the approach of researchers and/or policy-makers planning a detailed analysis of their own nhrs prior to embarking on exercises to strengthen it, and "[t]he findings emphasized that improvement of hrs functions requires addressing context-specific problems" [ ] . as an illustration, mansoori's review identified a need for "a more systematic, inclusive" approach to research priority-setting [ ] and, in the same stream of research, she co-led just such a priority-setting exercise to help address the knowledge gaps related to achieving both iran's national health policies and the sdgs [ ] . atkinson et al. examined the creation of what might be viewed as the most successful attempt to strengthen a health research system in their paper ''all the stars were aligned'? the origins of england's national institute for health research' [ ] . compared with mansoori, the authors adopted a different but equally detailed approach in their analysis, which was conducted principally through interviews and a witness seminar but also drew on the existing literature and documents [ ] . they showed how the formation of the nihr was led from the department of health by a key group driven by sally davies. they aimed to improve patient care through both the strengthening of evidence-based medicine and through boosting the infrastructure to facilitate pharmaceutical clinical trials that would also meet wider industrial and economic goals. as with mansoori's study, consideration was given to how the full analysis could be informative to any planned detailed study or reforms in any other country. the key observations were similar to the recommendations from the hen report with a focus on stakeholder engagement and building support: "[t]wo measures likely to contribute to political support are to place the greatest emphasis on 'problem' rather than 'investigation' research, and to devote attention to measuring and reporting research 'payback'" [ ] . atkinson et al.'s paper is also a link to the other main source considered here because it was a recent paper published in harps. in summary, if further analysis and research beyond that in the who evidence synthesis [ ] is thought to be relevant in the particular country looking to strengthen its health research system, this opinion piece indicates some of the types of additional sources of information that are available and how they might be organised. the vast literature on each function and the ever-growing evidence base are illustrated by considering papers in just one key journal, harps, and analysing the contribution of two national studies. a review of the functions of the iranian system identifies over relevant, mostly national, records and an analysis of the creation of the english nihr describes the key leadership role played from the health department. who is providing leadership? the above analysis demonstrates that there is no shortage of useful material on which to draw when strengthening health research systems. however, key questions remain as to who might best lead or steer attempts to strengthen such a system. the papers by both mansoori [ ] and atkinson et al. [ ] illustrate that, where a key committed individual has the capacity and opportunity to provide leadership, this can be a vital element in making progress. however, the institutional factors are also crucial. the hen developed the argument that a department or ministry of health will have a particular interest and perhaps experience in promoting research agendas that meet the needs of the healthcare system and in helping to develop mechanisms to use the findings from such research, where appropriate, to inform local policy and practice [ ] . the health ministry or a research council responsible to it played an important role in the various systems identified above as being effective, as was also the case in the waho initiative [ ] . in some cases, as with zambia, more progress was made once the ministry of health elected to play a more important role, sometimes in place of other stakeholders [ ] . examples of the important role that health ministries can play were described in the world health report, including on paraguay: "the support of the minister of health backed by the president of paraguay has been a key factor in the development of a national health research system" [ ] . additionally, naturally enough, the activities of the various who regional offices in boosting nhrss tend to focus on working with the national ministries of health, including work in europe [ ] and by paho [ ] . conversely, several analyses illustrate that progress in strengthening the nhrs might be limited where key parts of the ministry of health, for whatever reason, do not provide support [ , ] . nevertheless, some disadvantages or dangers were identified when the ministry of health plays the leading role. first, in england prior to the creation of the nihr as well as in some other countries, the research funds controlled by the health ministry were sometimes appropriated by other parts of the health system when they were under particular pressure for resources [ ] . similarly, there have been a few reports that health research funding lost out when donor funds that had previously been allocated specifically for health research programmes were replaced by donations of funds to be allocated by the nation's own health system according to its own priorities [ , ] . one way of attempting to mitigate the danger is, as undertaken by the nihr and described by atkinson, by building support for health research through measuring and reporting the payback from research [ , ] . the second danger arises because, traditionally, many researchers argued that the best science came when they had the freedom to identify the key research topics, rather than having priorities set by others [ ] . therefore, they argued, the responsibility for funding and organising health research should be left to organisations that are part of the research system and independent of the health system [ ] . furthermore, despite the growth of interest in coproduction approaches noted above, there have also been recent doubts raised about the assumption that coproduction is always the most appropriate approach [ ] . this issue clearly requires sensitive handling. indeed, atkinson et al. [ ] argue that one of the great successes of the nihr is that this issue has been so skilfully handled by the nihr that external input, or stakeholder engagement, in setting agendas has become widely accepted and the structures created give ministers a sense of ownership without sacrificing scientific independence. the efforts of waho [ , ] and the who regional offices for africa and paho [ , , , ] indicate that partnerships can be helpful. in europe, the who regional office worked with member states to create the european health research network, which is intended to help nations with limited nhrss who wish to make more progress [ ] . partnerships can provide important support and encouragement, but the evidence suggests there must be strong political will somewhere within the political and/ or health systems for a health research system to be fully strengthened. the central asian countries in who's european region seem to provide an illustration of this point. a cohred collaborative initiative successfully resulted in situation analyses being produced in each country and then jointly discussed as the basis for action [ ] , but according to the analysis by santoro et al. [ ] , limited progress seems to have been made in the subsequent years. the importance of partnerships and collaboration in focusing research efforts in an extreme crisis, with a leadership role for the who, has been seen in the race to find treatments for covid- and vaccines against severe acute respiratory syndrome coronavirus (sars-cov- ), which causes the covid- disease [ ] . in many nhrss across the globe, including in the philippines, scientists are coming together to participate in who's solidarity trial, which will test the safety and effectiveness of various possible therapies for treating covid- [ ] . sarah gilbert, leader of oxford university's jenner institute's work on developing one of the leading vaccine candidates explained that cooperation was vital for tackling the crisis: "work is continuing at a very fast pace, and i am in no doubt that we will see an unprecedented spirit of collaboration and cooperation, convened by who, as we move towards a shared global goal of covid- prevention through vaccination" [ ] . a key issue going forward is how such cooperation can be built on in strengthening nhrss into the future. for now, it is recommended that a prospective study be conducted to analyse all that is being done in different nhrss to speed up research during the pandemic, with a view to taking lessons about cooperation, partnerships and other matters into strengthening nhrss in the future [ ] . the who evidence synthesis, published as a hen report [ ] , provides a firm basis for decision-making by policy-makers and research leaders looking to strengthen the health research system in their country. it identifies five crucial policy approaches that can be applied as appropriate to the context of the countryconducting situation analyses, sustaining a comprehensive strategy, engaging stakeholders, evaluating impacts on health policies and practices, and partnership participation. it also analyses, in turn, the individual functions and components within a system and identifies a series of tools that can be used for strengthening many of them. if further analysis and research is thought to be relevant in the particular country looking to strengthen its health research system, this opinion piece indicates some of the types of additional sources of information that are available. the opinion piece also discusses aspects of the sometimes-controversial question of who should lead or steer attempts to strengthen nhrss. again, the context of the particular nation will be crucial in determining the most appropriate course to take, as emphasised by both mansoori [ ] and atkinson et al. [ ] , but at least some involvement of the ministry of health is likely to be beneficial; additionally, sometimes, key individuals can play a crucial leadership role in strengthening the whole system or one component. in countries with a less developed tradition of conducting health research, partnerships with other countries and/ or with international organisations can help lead the progress and learning for all partners. the valuable role that international organisations, such as who, can play in leading partnerships and cooperation to strengthen health research systems is being highlighted during the covid- crisis. overall, therefore, the full who hen report not only provides a detailed analysis of nhrs strengthening, it also provides a structure within which an even wider and ongoing literature can be considered. additionally, it contains a perhaps more nuanced account, on which this paper builds, of some aspects of the literature around the issue of who should provide leadership 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research programme experience isria statement: ten-point guidelines for an effective process of research impact assessment intervention scalability assessment tool: a decision support tool for health policy makers and implementers exempting low-risk health and medical research from ethics reviews: comparing australia, the united kingdom, the united states and the netherlands governance of health research funding institutions: an integrated conceptual framework and actionable functions of governance understanding the athena swan award scheme for gender equality as a complex social intervention in a complex system: analysis of silver award action plans in a comparative european perspective how do organisations implement research impact assessment (ria) principles and good practice? a narrative review and exploratory study of four international research funding and administrative organisations supporting the use of research evidence in decision-making in crisis zones in low-and 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towards fair and effective north-south collaboration: realizing a programme for demand-driven and locally led research bringing health research forward the dark side of coproduction: do the costs outweigh the benefits for health research? strengthening health research systems in central asia: a system mapping and consultative process from covid- research to vaccine application: why might it take months not years and what are the wider lessons who western pacific: philippines. ph solidarity trial for covid- treatments receives green light from ethics review body. press release. who. carving a path towards a covid- vaccine publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations authors' contributions sp, lk and sh planned the original phase of the who evidence synthesis, including the search strategy. lk led the original literature search and contributed article selection and data extraction and analysis. ab and sh planned the second phase of the evidence synthesis. tj led the second phase of the literature search and contributed to the article selection and data extraction. ab contributed to the final version of the health evidence network report. sh led the data extraction and analysis and drafting of the report. sh conducted the additional analysis of the literature and initial drafting for this opinion piece. all authors commented on the opinion piece and approved the final version. key: cord- -v ncshav authors: moghadas, seyed m.; pizzi, nick j.; wu, jianhong; yan, ping title: managing public health crises: the role of models in pandemic preparedness date: - - journal: influenza other respir viruses doi: . /j. - . . .x sha: doc_id: cord_uid: v ncshav background given the enormity of challenges involved in pandemic preparedness, design and implementation of effective and cost‐effective public health policies is a major task that requires an integrated approach through engagement of scientific, administrative, and political communities across disciplines. there is ample evidence to suggest that modeling may be a viable approach to accomplish this task. methods to demonstrate the importance of synergism between modelers, public health experts, and policymakers, the university of winnipeg organized an interdisciplinary workshop on the role of models in pandemic preparedness in september . the workshop provided an excellent opportunity to present outcomes of recent scientific investigations that thoroughly evaluate the merits of preventive, therapeutic, and social distancing mechanisms, where community structures, priority groups, healthcare providers, and responders to emergency situations are given specific consideration. results this interactive workshop was clearly successful in strengthening ties between various disciplines and creating venues for modelers to effectively communicate with policymakers. the importance of modeling in pandemic planning was highlighted, and key parameters that affect policy decision‐making were identified. core assumptions and important activities in canadian pandemic plans at the provincial and national levels were also discussed. conclusions there will be little time for thoughtful and rapid reflection once an influenza pandemic strikes, and therefore preparedness is an unavoidable priority. modeling and simulations are key resources in pandemic planning to map out interdependencies and support complex decision‐making. models are most effective in formulating strategies for managing public health crises when there are synergies between modelers, planners, and policymakers. influenza pandemics have historically been devastating to humanity with significant morbidity, mortality, and socioeconomic costs. the - pandemic, the so-called ''mother of all pandemics,'' was responsible for over million deaths among countless infections worldwide. today, years after the last pandemic in , the world may be on the brink of another major global pandemic, with a toll that could exceed that of the - pandemic. while the nature of the next influenza pandemic cannot be predicted with certainty, the identification of strategies to effectively curtail the spread of disease is an unavoidable priority in responding to this global threat. in light of this, the university of winnipeg hosted a multidisciplinary workshop on the role of models in pandemic preparedness. the workshop brought together public health experts, key decision makers, and infectious disease modelers to: (i) identify the strengths and weaknesses of mathematical models, and suggest ways to improve their predictive ability that will ultimately influence policy effectiveness; and (ii) provide an opportunity for the discussion of priority components of a pandemic plan and determine key parameters that affect policy decision making. the first day of this workshop consisted of several outstanding presentations by modelers with the purpose of forging strong links between theory, policy and practice. these included evaluations and model predictions for antiviral strategies and their implications for drug stockpiling; the role of population contact networks in the emergence and spread of drug-resistance; targeting influenza vaccination at specific age groups; optimal control of pandemic outbreaks; and the usefulness of non-pharmaceutical interventions in disease mitigation. dr. chris bowman (institute for biodiagnostics, national research council canada) presented the findings of two modeling studies for the management of drug-resistance in the population, , especially when concerning the scarcity of antiviral supplies. these studies suggest that an adaptive antiviral strategy with conservative initial treatment levels, followed by a timely increase in the scale of drug-use, can minimize the final size of a pandemic while preventing the occurrence of large resistant outbreaks. dr. bowman emphasized that the strategic use of drugs may involve decisions for rationing of limited stockpiles and prioritizing high-risk individuals, and therefore ethical considerations should be taken into account for maximum protection of community health. a comparative evaluation of antiviral strategies in homogeneous and heterogeneous population interactions was presented by dr. murray alexander (institute for biodiagnostics, national research council canada). he underscored the importance of prolonging the effectiveness of antiviral drugs through an adaptive treatment strategy, in particular for heterogeneous community structure in which the wide-spread of resistance is more likely to take place. these presentations also provided a brief overview of some recent studies carried out by canadian modelers in the subject of pandemic preparedness. [ ] [ ] [ ] [ ] [ ] dr. babak pourbohloul (director, mathematical modeling, bc centre for disease control) proposed an important question regarding ''a forced marriage'' or ''necessity for integration'' between mathematical models and public health policy. in his summary of the day, dr. pourbohloul acknowledged that the talks were very encouraging and pointed towards integration and development of modeling platforms that could inform policy in canada. he also highlighted the significant progress evident since the first pandemic meeting in vancouver, , during which very little could be communicated to policymakers regarding the value of modeling perspectives. dr. pourbohloul drew attention to various models presented in the workshop, which attest to the fact that we are not lagging behind the current methodology in canada, but rather are in the forefront. [ ] [ ] [ ] [ ] [ ] [ ] [ ] however, the central issue is not this, but integration with public health, which is the approach taken by us and uk colleagues for disease modeling and management. a major drawback for canadian modelers is the lack of appropriate infrastructure, and this calls for investments from healthcare departments and government organizations that could provide modelers with the impetus to continue development of more realistic models. with regard to models used for pandemic planning, we need to critically evaluate their implications for policy implementation. there are two major reasons underlying this evaluation: first, data are limited and prior to the emergence of a novel pandemic strain, it is not possible to study the epidemiological impact of disease or interventions in a real world environment; second, public health authorities would need to be prepared for all the likely scenarios that could influence the outcome of preparedness strategies. models, by definition, are not supposed to be perfect; approximations are necessary and predictions are made on this understanding. however, a more important question is how much of the knowledge of canadian modelers has been employed to support policy decision-making? is it all based upon experience of other countries? perhaps in canada, there has not been much communication between modelers and policymakers and therefore modeling results have not been translated into the context of public health. the time has now come to build a pandemic consortium in canada to have a unified voice from modelers, and close the gaps with infectious disease experts and public health colleagues. dr. susan tamblyn (co-chair, canadian pandemic antivirals working group) also emphasized the importance of making progress on linking the modeling with decision making within canada. these enterprises are still really separate in canada, whereas the value of modeling groups working very closely with the government and health departments is clearly evident in a few countries. we seem to have this linkage in a couple of provinces in canada, but it is not elevated to the national level. as planners, they understand that modeling can help formulate pandemic policies; however, the lack of collaboration with canadian modelers obliged them to turn to outside results from published models. hopefully, the two groups can work closer together to have beneficial impact with regards to pandemic preparedness. dr. tamblyn also expressed her concern about public health questions, which often are not amenable to modeling, and about modeling studies that use unrealistic assumptions and scenarios. therefore, modelers should also be fully engaged in the process of formulating the questions that policymakers need to address in planning for a pandemic. the point was highlighted by dr. ping yan (centre for communicable disease and infection control, public health agency of canada) that models should be based on realistic assumptions to create fundamental knowledge in all aspects of pandemic research. on the second day, the workshop comprised several presentations by participants from the public health domain. these included unanswered questions concerning the emergence of novel infectious diseases; understanding the space-time dynamics of influenza spread; influenza mortal-ity in pandemics and seasonal outbreaks; the impact of global air transportation on the spread of diseases; the role of models in public health planning and decision making; the evolution of pandemic influenza viruses; and the potential for novel means to prevent these pandemics. dr julien arino (university of manitoba) outlined the objectives of an ongoing data-driven project that aims to draw out the likely patterns of disease spread through the network of all international airports in the world with direct and indirect connections. this investigation can have important implications for heading off a global pandemic, with a particular focus on the optimal allocation of containment resources in the most probable ports of disease introduction and spread in canada. this presentation was followed by an overview of the ontario government's pandemic preparedness plan (allison stuart, assistant deputy minister of the ontario ministry of health and long-term care), which provides the most comprehensive provincial plan in canada, having undergone five iterations developed over a -year period. this plan details guidance to local planners and specific strategies for health sector sub-groups (critical care, pediatrics, laboratories, long-term care, persons with chronic diseases, mental health settings), first responders, faith groups, private sector organizations, and first nations communities. this presentation also included a list of concerns which modeling should address relating to acute care services (e.g., estimated hospital surge capacity for a given jurisdiction during a pandemic); local implementation (e.g., identification of the tipping point when primary care will not be able to meet the - hour standard of care); and antivirals (e.g., identifying the optimal use of drugs and distribution methods for treatment and prophylaxis to decelerate the spread of a pandemic). dr. joanne langley (co-chair, canadian pandemic vaccine working group) presented a detailed analysis of the potential benefits and uncertainties relating to the standard pillars of pandemic influenza contingency plans, covering antiviral drugs; healthcare delivery planning; vaccines; public health measures; and infection control practices. this included the importance of personal protective equipment such as the n mask in the healthcare setting, the need for regular and frequent hand washing, and a risk analysis of potential amantadine resistance. dr. langley also stressed the need for ''real time'' modeling to provide a rapid analysis of alternative tactical decisions following the onset of a pandemic. dr. mark walderhaug (associate director, us center for biologics evaluation and research, fda) discussed a stock-and-flow model used for simulating the impact of an influenza pandemic on the us blood supply. the model assumes that susceptibility to the pandemic virus will be universal; multiple waves of infection can occur and each wave adversely impacts infected communities for - weeks; and absenteeism may reach as high as % dur-ing the peak periods. model simulations for the entire us blood supply were presented, and the need for acquiring detailed data of inter-regional flow of blood was emphasized. these data are essential for projecting various scenarios, including run-out for hospitals despite adequate national supplies and time frames for elective surgery cancellations while the blood supply recovers, which highlight the significant challenges involved in supply distribution. dr. paul gully (senior advisor, world health organization) emphasized the fact that models are essential for guiding public health, but may also raise more questions for policymakers. he expressed growing concerns about being able to fulfill the requirements for pandemic containment that come from modeling studies: ''models lead to policy but have to confront political reality''. previous work suggests that a nascent influenza pandemic can be contained at the source if antiviral therapy for a sizable proportion of affected individuals ( - %) is accompanied by a rapid implementation of non-pharmaceutical measures (such as movement restriction) over a very short period of time (days to weeks). , on serious discussions from a political standpoint, dr. gully demonstrated the significant challenges involved in building the capacity for a timely response to meet the condition for averting a global pandemic. despite these challenges, he acknowledged that models are invaluable tools for making assumptions explicit and for best using limited data, highlighting key factors determining policy needs, and providing quantitative predictions. discussions of the day were then expanded to the implementation of various strategies from a transmission dynamic standpoint. in their capacity, what models offer should be taken along with other health and economic factors to guide sound public health policies. they are not meant to make decisions on managing public health crises, but rather provide recommendations to policymakers. however, for rapid decision making, one would need to consider the interface between simple, interactive, and relatively complex models that may encapsulate population demographics pertaining to the location of a pandemic outbreak. dr. tamblyn chaired the summary and discussion session of the workshop on day , and acknowledged the true interdisciplinary nature of the meeting, enriched discussions, very interesting and relevant presentations, with kudos for planning long health-breaks that allowed for interactions and flow of emerging ideas. she distinguished the meeting as the one that has met its objectives and provided an opportunity for effective communications between modelers and public health authorities on the subject of pandemic preparedness in canada. dr. ying-hen hsieh (china medical university, taiwan) offered his perspectives on the workshop with great potential for expanding collaboration with canadian colleagues in future work. the meeting highlighted important aspects of canadian public health that will be useful for creating an effective venue to communicate with public health in taiwan. dr. hsieh, as a prominent modeler in taiwan, shared his experience with sars (severe acute respiratory syndrome) and exemplified the opportunities missed by public health to engage modelers: ''by the time they called me in, it was weeks before the end of sars outbreaks''. in , there was a cabinet agreement to promote an influenza vaccine r&d program in taiwan, partly for the economic opportunities it offers; he was brought in after the decision was made with the hope that ''modelling results will be in line with government policy''. he depicted that in public health in taiwan, a highly challenging task has been to establish collaborative efforts, but the important lesson from this workshop is to understand the process of making decisions, identify its key parameters, and determine effective ways to communicate with policymakers. dr. benjamin ridenhour (us center for disease control) acknowledged that the workshop had been successful in bringing together the communities involved in pandemic preparedness, to share their various viewpoints and expertise in modeling and public health, in a very congenial and friendly environment. the us center for disease control has made substantial efforts to co-ordinate pandemic activities through synergism between public health officials and modelers, which has led to benefits for planning strategies in the united states. as modelers, we need to strengthen our ties to public health, and exploit our potential for developing models that can inform and optimize health policy decisions. this workshop has demonstrated that strong networking is required to adequately prepare for the pressure of real time crises, and cope with surging demands in a pandemic-related emergency. in closing the workshop, dr. seyed moghadas (institute for biodiagnostics, national research council canada) valued the time and efforts of participants and appreciated their contributions to the success of this event. key points inferred from presentations and discussions include: . in canada, the pandemic goals are to (i) minimize serious illness and overall deaths; and (ii) minimize social disruption. pandemic containment has not been a priority to date and may not be feasible. development of a pandemic vaccine may take up to months following pandemic detection. however, as novel influenza strains most often emerge in asia, strong surveillance leading to early detection there can increase our lead time for pandemic vaccine production. . immunization of children can result in significant changes in contact patterns and attack rates. age is a surrogate for individual behavior that influences pathogen transmission in the population; vaccine efficacy may also vary in different age groups. . antiviral therapy is the cornerstone of the pandemic response in canada until vaccine is available; however, implementation of the strategy is determined by pandemic planners at the provincial level. the meeting provided an opportunity for modelers to engage in detailed discussions about modeling strategies that can be employed for gaining new insight into disease processes at the population level and making findings of public health significance. while models serve to synthesize data and suggest optimal scenarios in public health, they can also promote dialogue between modelers and policymakers about alternatives, uncertainties, and assumptions that underlie critical decisions. the workshop revealed that pandemic planning requires involvement of communities across disciplines with firm commitment to the notion that research must ultimately influence policy. a history of influenza influenza: the mother of all pandemics avian influenza h n : is it a cause for concern? workshop on managing public health crises population-wide emergence of antiviral resistance during pandemic influenza antiviral resistance during pandemic influenza: implications for stockpiling and drug use emergence of drug-resistance: implications for antiviral control of pandemic influenza a delay differential model for pandemic influenza with antiviral treatment simple models for containment of a pandemic the impact of prophylaxis of healthcare workers on influenza pandemic burden management of drug-resistance in the population: influenza as a case study strategies for containing an emerging influenza pandemic in southeast asia containing pandemic influenza at the source the workshop was funded by the mathematics of information technology and complex systems (mitacs), public health agency of canada (phac), international centre for infectious diseases (icid), national research council canada's institute for biodiagnostics (nrc-ibd), and the university of winnipeg. we wish to express our appreciation to all the participants for their significant contribution to the workshop. the authors, as the organizing committee, would like to thank margaret montague, sarah dietrich, and justyna swistak for assistance with meeting logistics. the authors declare that they have no competing interests. sm, np, jw, and py proposed and organized the workshop. sm summarized and drafted the preliminary version of this manuscript based on presentations and round-table discussions. all the authors have contributed to this manuscript, and approved its final version. key: cord- -vofar b authors: atique, suleman; bautista, john robert; block, lorraine j.; lee, jay jung jae; lozada‐perezmitre, erika; nibber, raji; o’connor, siobhan; peltonen, laura‐maria; ronquillo, charlene; tayaben, jude; thilo, friederike j.s.; topaz, maxim title: a nursing informatics response to covid‐ : perspectives from five regions of the world date: - - journal: j adv nurs doi: . /jan. sha: doc_id: cord_uid: vofar b the st century has seen several infectious disease outbreaks that have turned into epidemics and pandemics including severe acute respiratory syndrome (sars) which began in asia in (poon, guan, nicholls, yuen, & peiris, ), followed by h n that emerged in mexico and the united states in (belongia et al., ). next came the lesser known middle east respiratory syndrome (mers) originating in saudi arabia in (assiri et al., ), after which the ebola outbreak in west africa took place from to , with a more recent occurrence in the democratic republic of congo from to (malvy, mcelroy, de clerck, günther, & van griensven, ). to date, the coronavirus (covid‐ ) outbreak that started in wuhan, in the hubei province of china, in late december seems to be eclipsing all of these previous infectious diseases in terms of its global reach and impact (wang, horby, hayden, & gao, ). after being declared by the world health organization (who) as a public health emergency on january (world health organization, c), it was elevated to a pandemic status on march (world health organization, d). as of april , there are more than . million cases and , deaths reported worldwide (world health organization, b). the st century has seen several infectious disease outbreaks that have turned into epidemics and pandemics including severe acute respiratory syndrome (sars) which began in asia in (poon, guan, nicholls, yuen, & peiris, ) , followed by h n that emerged in mexico all of these previous infectious diseases in terms of its global reach and impact (wang, horby, hayden, & gao, ) . after being declared by the world health organization (who) as a public health emergency on january (world health organization, c), it was elevated to a pandemic status on march (world health organization, d). as of april , there are more than . million cases and , deaths reported worldwide (world health organization, b) . healthcare workers around the world e.g. nurses, medical doctors, community healthcare workers are on the front lines caring for those infected (zhang, sun, latour, hu, & qian, ) , while epidemiologists, public health officials and others work behind the scenes to control the spread of covid- and protect population health. scientists across many disciplines are also researching how to address the myriad problems that this disease has created and exacerbated, this article is protected by copyright. all rights reserved such as the shortage of personal protective equipment (chughtai, seale, islam, owais, & macintyre, ) , the need for more critical care facilities and expertise (grasselli, pesenti, & cecconi, ) , the development of therapeutics (dhama et al., ) and new vaccines that could prevent the virus in the future (anderson, heesterbeek, klinkenberg, & hollingsworth, ) . nursing informaticians who use information technology to enhance nursing education, clinical practice and policy are collaborating with colleagues and contributing to and leading research and digital health initiatives in the face of covid- . here, we discuss some perspectives from the international medical informatics association -nursing informatics (imia-ni) group based in nine countries across five regions of the world (ronquillo, topaz, pruinelli, peltonen, & nibber, ) . we explain how the nursing informatics community is responding to this global crisis and offer some early lessons learned that could be useful in future outbreaks of infectious disease. despite the swift implementation of a lockdown of the hubei province, covid- spread beyond chinese borders. approximately , people cross the shared border between hong kong and china per day (hong kong immigration department, ), posing a risk of repeating the sars outbreak more than a decade earlier that killed people in hong kong (world health organization, ) . within days of the first reported case of coronavirus, the hong kong government raised the response level to 'emergency' (cheung, lok-kei , lau, & ho-him, ) . this saw the halting of transportation to and from wuhan, the cancellation of large events in spite of the lunar new year celebrations, an extension of school holidays and work from home arrangements (lum & lok-kei, ) . however, the outbreak triggered painful memories of the sars epidemic for many residents who were already mired in a time of civil unrest and government dissatisfaction throughout and (lau & cheung, ; stevenson, ramzy, & may, ) . despite the government justifying the maintenance of its borders with china, pressure from the public and healthcare workers, as well as a burgeoning rise in local covid- cases led to border closures and the suspension of schools and examinations (hohim, ) . in response, nursing informaticians in hong kong are helping to move nursing education fully online to support students, while teaching about this new infectious disease this article is protected by copyright. all rights reserved through social media and developing virtual learning activities around public health interventions. among southeast asian nations, the philippines ranks high on the list of countries with the total number of cases and deaths from covid- (center for strategic and international studies, ). the government placed the largest of the islands, luzon which includes the capital city of manila (home to about million people), in enhanced community quarantine (i.e. lockdown) on march to reduce the impact of the disease on the country's healthcare system (gregorio, ) . despite being a top global exporter of healthcare workers (castro-palaganas et al., ) , the philippines is now experiencing a lack of nurses and other clinicians to serve during the pandemic. as a result, the government called for healthcare worker volunteers in march (cruz-bacani, ) and temporarily banned overseas deployment of healthcare workers in april (abs-cbn news, b). the main nursing associations including the philippine nurses association, filipino nurses united and ang nars are urging the government to give nurses higher wages, on top of the ₱ pesos (usd $ ) per day allowance announced, to mitigate nurse migration and ensure they are adequately compensated for the high risk, critical role they provide caring for people infected with covid- (abs-cbn news, a; deleon, ). in response to the pandemic, nursing informaticians in the philippines are helping to deploy distance learning and e-learning technologies to ensure nursing students and professionals are adequately trained. social media is also being used to disseminate appropriate health information to local communities across the numerous islands and provide emotional support to nurses working on the frontlines caring for those infected. like other regions, covid- quickly spread to almost all parts of the middle east. the kingdom of saudi arabia is one of the countries in the arab world that has been significantly affected with more than , cases (abueish, ). the holy month of ramadan which requires fasting, prayer and reflection started on the evening of the april and lasts for thirty days which could make self-isolation and social distancing challenging (atique & itumalla, ). in addition, millions of muslims would normally undertake the umrah, an islamic pilgrimage to mecca, which the government cancelled in a bid to repress the spread of the disease (ebrahim & memish, ; gautret, al-tawfiq, & hoang, ) . the middle this article is protected by copyright. all rights reserved eastern region, especially the kingdom of saudi arabia, is already facing the mers and therefore further vigilance is required to combat covid- (jazieh et al., ) . the ministry of health has directed healthcare workers to strictly follow the previous guidelines for mers as this is an emerging and complex situation (ministry of health, ). the country largely relies on a foreign workforce which come from around the globe to staff its health sector, bringing knowledge and skills from a diverse range of nationalities and ethnicities. furthermore, some hospitals have started telemedicine and related digital services to provide healthcare to people at home (saudi german hospitals, ). in response to the pandemic, nursing informaticians in the kingdom of saudi arabia are helping to provide digital health and care services such as telemedicine. they are also using online tools to reach and educate patients and local communities about the disease to help reduce transmission and rates of infection. europe has been the epicentre of the pandemic for several weeks, with italy, spain, france and the united kingdom (u.k.) amongst the countries with the highest number of reported cases and deaths from covid- (henley & pilkington, ) . in the u.k., the prime minister boris johnston, who was hospitalised in critical care with the coronavirus (stewart & campbell, ) and the tory political party that holds the government majority, initially took an alternative approach to tackling the disease by advocating for 'herd immunity' on march (yong, ) . the tory party leadership suggested that most of the population, approximately million across four countries (england, northern ireland, scotland and wales), should become infected to enable healthy individuals to build up an adequate immune response to this highly contagious disease (horton, ). this was followed by mixed messages around social distancing and self-isolation mid-march , despite the rapidly rising death tolls in italy and spain where british citizens were holidaying at the time (hunter, ). it has garnered a varied response from professionals and the public alike, both at home and abroad, given this does not follow the traditional public health response to an infectious disease outbreak that includes testing, contact tracing and isolating potentially infected individuals (alwan et al., ; hellewell et al., ) . despite a change in u.k. policy away from this approach, some of the conversations surrounding this debacle and others such as the shortage of personal protective equipment and critical care beds have reverberated on social media. these data are now being this article is protected by copyright. all rights reserved analysed by nursing informaticians, as twitter and other online platforms can be used to discern trends in the public's perception of important health related issues which can be used to inform and promote health protection (meng, kath, li, & nguyen, ) . other nurse informaticians are working to develop digital dashboards to monitor and improve the quality of care in acute hospital settings (randell et al., ) . switzerland, a country with . million inhabitants living across cantons and languages regions (french, german, italian and rhaeto-romance), is responding to the covid- pandemic by closing non-vital services and implementing who recommendations such as rapid testing, case isolation or self-isolation and social distancing (federal office of public health, ; salathé et al., ) . like many countries, the health service and frontline clinicians face numerous challenges such as the shortage of personal protective equipment, disinfectant and ventilators and a lack of knowledge on how to prevent, diagnose and treat the disease. these rapid changes have expediated a digital transformation in switzerland with family doctors and hospital laboratories exchanging data in more structured, electronic ways and patients remotely monitored by nurses and physicians using telemedicine or telecare systems (wanner, ) . in addition, numerous scientific research initiatives have begun to address some of these challenges. one example is the corona science community, an interdisciplinary group of researchers including nursing informaticians, who are working with sponsors and partners to provide an application to collect anonymised, aggregated self-reported data related to covid- . this includes measures for physical health, psychological wellbeing and social impact e.g. employment, education and home schooling, caring responsibilities and community activism, to enable a better understanding of this infectious disease (corona science, ). in finland, the government declared a state of emergency in march and this article is protected by copyright. all rights reserved of the government called media pool, which supports media organisations in finland and a marketing company, pink helsinki, jointly launched a national social media campaign to counteract misinformation about the infectious disease (finnish government, a) . nationally, the finish institute for health and welfare continuously update their online resources with information and materials on covid- for professionals and the public (finnish institute for health and welfare, ). existing digital health services have also been expanded. for example, an online symptom assessment tool called "omaolo" is available to help the public gauge the likelihood of a coronavirus infection and provide referral and treatment advice (sotedigi oy, ) . a "coronabot" web service that gives guidance regarding exposure to and symptoms of covid- has also been established via a collaboration across hospitals in helsinki, tampere, oulu, kupio and turku (health village, ). nursing informaticians in finland have assisted these efforts by developing covid- related data interfaces for electronic health records, providing digital education on caring for those infected with the virus and improving mobile documentation to speed up access to real-time patient information. in canada, the structure of healthcare provisioning is determined by provincial governments which has resulted in variations in the public health and political response to the covid- pandemic. nevertheless, there are concerted efforts across the country to focus public education and policy on physical distancing as a key strategy to "flattening the curve" and preserving a level of acute care capacity for those that need it (woods, ) . this has led to a restructuring of healthcare service delivery via the increased use of health information technologies. in western canada, there has been a push for virtual health teams to increase capacity for telehealth appointments (e.g. telephone, video conferencing, email and text) to deliver patient care (provincial health services authority, ). this rapid development and implementation of digital services has required nursing informaticians to lead much of this work. furthermore, virtual teaching tools have been created to help prepare nurses, nursing students and retired nurses entering frontline health services to support covid- efforts. these include online educational resources related to the clinical presentation, detection and care (e.g. e-learning module on the use of personal protective equipment) of people diagnosed or suspected to have the infectious disease (canadian institute of health information, ; canadian nurses association, ). a systematic and centralised approach to collecting, coding (using the who this article is protected by copyright. all rights reserved international classification of disease), synthesising and sharing up-to-date information about coronavirus cases is also underway among the health informatics community, who are adopting new digital and visualisation tools to enable better epidemiological modelling (canadian institute of health information, ). in the united states (u.s.), the federalist system of public health governance divides powers among the federal, state and local governments. each of these entities has an authority, to some extent, to initiate responses to the covid- pandemic. early in march , federal government in the u.s. started its response by introducing a travel ban on flights from china. further federal policies included declaring a national "state of emergency" and providing financial stimuli to the u.s. economy (wallach & myers, ) . although responses varied from state to state, virtually all states have issued stay-at-home orders for non-essential workers as of early april (national conference of state legislatures, ). in late april , the situation remains dire, with the u.s. becoming an epicenter of covid- cases and deaths worldwide. nursing informaticians in the u.s. have responded to the covid- pandemic in several important ways. in educational settings, nursing informaticians have supported the switch to the online education mode to reduce in-person contact between nursing students. in clinical settings, nurse informaticians are using a diverse range of health data to help alleviate the impact of covid- . for example, nurse informaticians across hospitals in new york have built efficient and streamlined ways of tracking the availability and forecasting the need in critical health equipment, such as ventilators. in other initiatives, nurse informaticians are collaborating on providing access to timely data, for example guidelines on nursing responses to the covid- pandemic (omaha system community of practice, ). in addition, nurse informaticians have contributed to creating ways of assessing covid- related symptoms; for example, by contributing to the creation of an online survey covidwatcher that tracks disease symptoms (university of columbia, ). finally, latin america and the caribbean have been the last major region of the world to experience the coronavirus. the government and public response to covid- has varied due to the differing health systems, economies and politics of each country. however, high levels of inequality and poverty (santos & villatoro, ) , along with limited health systems capacity this article is protected by copyright. all rights reserved and a lack of healthcare workers are common characteristics amongst many latin american countries (laurell, c., & giovanella, ) . the first confirmed coronavirus case was in brazil on february and argentina was the first country to confirm a death on march related to covid- (world health organization, a) . the demographic profile in latin america is younger with a smaller percentage of individuals over (pan american health organization, ). despite having a younger profile, the socioeconomic disparities in health, access to healthcare and the prevalence of chronic diseases raises the possibility of needing intensive care (biener & zuvekas, ) . in mexico, the government restricted international travel, banned large gathering events and encouraged social distancing to limit people's exposure by staying at home. the government has been widely critiqued for delaying action to limit the spread of the virus, reasoning the costs of closing down industries would have a negative impact on the economy. however, it is complicated to limit exposure as approximately % of the population have informal jobs (organisation for economic co-operation and development, ). as over million people reside in mexico, there is a need to use virtual health. hence, the government has developed a website and an app where signs and symptoms of the disease and how to prevent transmission of the virus are explained to help educate the public (secretaria de salud de méxico, ). telehealth is also beginning to be used to remotely monitor the health of at risk populations and to reduce the numbers of people presenting at local hospitals, with many nursing informaticians involved in these initiatives (sood, pollard, le suer, vlahovich, & walker, ) . to conclude, nursing informaticians worldwide are working with colleagues in clinical settings to advance and implement electronic systems and digital infrastructure that supports healthcare professionals caring for patients with covid- , while those in educational settings prepare and deliver virtual learning to train nursing students and nurse practitioners about the infectious disease. many nursing informaticians are also researching how different technologies can be employed to understand the spread of the virus and its impact on people's health and wellbeing. some early lessons learned during this pandemic are to leverage interdisciplinary networks to scope out robust platforms for symptom and disease monitoring, collaborate with the technology industry to scale up digital solutions for health professionals, patients and their families and capitalise on existing social media and health applications to reach key stakeholders this article is protected by copyright. all rights reserved quickly such as at risk vulnerable groups. more work still needs to be done, in particular by employing artificial intelligence and visualization tools on real-time covid- datasets to enhance decision making by clinicians, policy makers and the public. the international nursing informatics community plan to convene in australia for their bi-annual conference in august , after postponing the original july event (https://ni .org/). here, covid- and how it is being tackled across the regions of the world is likely to take centre stage so that the technical, organisational, social, cultural and political challenges we face can be discussed and new ideas about how technology and informatics can help nurses address them are generated. saudi arabias measures to curb the covid- outbreak: temporary suspension of the umrah pilgrimage new coronavirus combating coronavirus together by sharing reliable information prime minister's office appoints operations centre to support management of covid- situation. government communications department coronavirus covid- -latest updates covid : will the hajj pilgrimage and tokyo olympic games be cancelled? travel medicine and infectious disease critical care utilization for the covid- outbreak in lombardy, italy: early experience and forecast during an emergency response movement of people in luzon restricted as island placed under 'enhanced' community quarantine epidemic bot: corona covid- feasibility of controlling covid- outbreaks by isolation of cases and contacts state action on coronavirus (covid- ) covid- response presentation of the economic survey of mexico health status of the population; population characteristics and trends the aetiology, origins and diagnosis of severe acute respiratory syndrome office of virtual health how, in what contexts and why do quality dashboards lead to improvements in care quality in acute hospitals? protocol for a realist feasibility evaluation competency recommendations for advancing nursing informatics in the next decade: international survey results. paper presented at the studies in health technology and informatics covid- epidemic in switzerland: on the importance of testing, contact tracing and isolation a multidimensional poverty index for latin america saudi german hospitals group" provides a new service "at home" to treat patients at their homes información sobre servicios digitales caring for miners during the coronavirus disease- (covid- ) pandemic. the journal of rural health in hong kong, the coronavirus strikes a wounded city. the new york times nhs workers angered at hancock's warning not to overuse ppe. the guardian the federal government's coronavirus response-public health timeline a novel coronavirus outbreak of global health concern accepted article this article is protected by copyright. all rights reserved das schweizer gesundheitswesen rüstet auf flatten the curve: what it means for coronavirus in canada. the huffington post summary of probable sars cases with onset of illness from coronavirus disease (covid- ) novel coronavirus ( -ncov) situation reports statement on the second meeting of the international health regulations ( ) emergency committee regarding the outbreak of novel coronavirus ( -ncov) who director-general's opening remarks at the media briefing on covid- - accepted article this article is protected by copyright. all rights reserved the u.k.'s coronavirus 'herd immunity' debacle. the atlantic hospital response to the covid key: cord- -jmetfa x authors: macdougall, heather title: toronto’s health department in action: influenza in and sars in date: - - journal: j hist med allied sci doi: . /jhmas/jrl sha: doc_id: cord_uid: jmetfa x this article compares the toronto health department’s role in controlling the influenza epidemic with its activities during the sars outbreak in and concludes that local health departments are the foundation for successful disease containment, provided that there is effective coordination, communication, and capacity. in , toronto’s moh charles hastings was the acknowledged leader of efforts to contain the disease, care for the sick, and develop an effective vaccine, because neither a federal health department nor an international body like who existed. during the sars outbreak, hastings’s successor, sheela basrur, discovered that nearly a decade of underfunding and new policy foci such as health promotion had left the department vulnerable when faced with a potential epidemic. lack of cooperation by provincial and federal authorities added further difficulties to the challenge of organizing contact tracing, quarantine, and isolation for suspected and probable cases and providing information and reassurance to the multi-ethnic population. with growing concern about a flu pandemic, the lessons of the past provide a foundation for future communicable disease control activities. (sars) in mount sinai hospital in april exemplifies the fear and concern that outbreaks of infectious disease provoke in the families of frontline workers. for historians, both the role of the media in highlighting the dangers of an epidemic outbreak and the response of health authorities recalled nineteenth-and twentieth-century reactions to cholera, typhus, yellow fever, smallpox, bubonic plague, and poliomyelitis rather than hiv/aids. but what part was toronto's health department to play in an international health crisis? as the sars outbreak once again demonstrated, local public health organizations are the foundation for concerted community efforts to manage disease and control public panic. by comparing and contrasting the way in which public health authorities in toronto managed the influenza pandemic and sars in , we can see how a century of medical advances had conditioned the public and health care professionals to expect prompt control of communicable diseases, speedy development of a prophylactic vaccine, and effective exchange of information at the provincial, national, and international levels. but both outbreaks also demonstrated the power of negative ethnic and class stereotyping, the impact of the media in both educating and frightening the public, and the high cost in terms of human lives and devastation of the local and national economies. in and , the worldwide influenza pandemic is estimated to have killed between and million people. for european and north american nations who were just coming to the end of world war i, with its toll of to million dead and wounded, the flu seemed to be the fourth horseman of the apocalypse. war, famine, pestilence, and death challenged canadians, americans, and their allies and foes both to respond to the immediate threat and to institute more formal national and international organizations to ensure that future pandemics were controlled before they could spread beyond their countries of origin. the great pandemic also gave further impetus to biomedical research that resulted in the discovery of the causative virus by british researchers in . as research continued, however, the complexity of influenza strains became apparent. but did public perceptions of the disease change? was it seen as a . in her study the gospel of germs: men, women, and the microbe in american life (cambridge, ma: harvard university press, ), nancy tomes presents a convincing argument about the impact of the "germ" theory on american attitudes to infectious disease and demonstrates how various groups adapted new behavior patterns and beliefs as a result. more recently, in "epidemic entertainments: disease and popular culture in early-twentieth-century america," am. lit. hist., , , - , she examines how contemporary problems such as the aids, ebola, and west nile viruses have been used by the media to create a climate of fear that prompts citizens to ignore significant public health threats by focusing on exotic and unlikely "risks." but her focus is on the way that advertising agencies used scientific discoveries in the mid-twentieth century to sell products by claiming to educate consumers in basic health principles. the use of radio and film for similar purposes is also analyzed to demonstrate the way that science becomes part of popular discourse and is, in turn, modified by popular perceptions. killer or simply as an annual nuisance that appeared in north america every fall and winter, after it had completed its attacks on the southern hemisphere and australasia? in , the question for many epidemiologists and health authorities was whether sars was the feared new version of the strain or another type of disease. lack of a readily available diagnostic test or specific symptomatology significantly hampered health authorities' response to the outbreak and prompted some officials to seek historical precedents for their containment efforts. by their very nature, epidemics reveal the strengths and weaknesses of the societies in which they occur. using toronto as a case study to examine the reaction of citizens and their health departments to influenza in and sars in provides an opportunity to probe into the changing role of local health departments and their staffs in two key crises. in , toronto was a bastion of white anglo-saxon protestantism, with less than % of its population of neither canadian nor british origin. the city had undergone a wave of physical expansion through the amalgamation of newly developed suburbs prior to and was the focal point for industry and commerce in ontario. as the provincial capital, it not only housed the legislature, the provincial board of health, the principal university, and the leading medical facilities, but also administered a budget equivalent to that of the provincial government. overshadowing these characteristics was toronto's fervent support of the war effort; it was the most imperialistic of canadian cities in , and for four long years, its , citizens provided volunteers for the canadian expeditionary force (cef), the canadian army medical corps (camc), and field hospitals in france, britain, and canada. civilians played their part and turned out munitions, food supplies, and clothing; bought war bonds; and planted victory gardens. the arrival of a virulent strain of influenza with the returning soldiers added further stress to the final days of the conflict and challenged existing public health staff to organize to combat disease with limited numbers, limited medico-scientific knowledge, and limited resources. by , the former city of toronto had been forcibly amalgamated with five surrounding municipalities to create a combined population totaling . million, nearly % of whom had not been born in canada. from on, the city had been a magnet for successive waves of refugees and immigrants seeking a better life for their children. by the s, toronto was the dominant economic engine for the nation. but as the federal and provincial governments adopted thatcherite and reaganite economic policies, the city lost much needed funding for its aging infrastructure and services. this did not bode well for toronto's health department, which relied on municipal taxes as well as provincial grants. furthermore, in the province updated the mandatory programs that local health units were expected to provide, and then changed the tax base to limit business taxes that toronto had used to fund innovative health and education programs. was toronto ready for a possible pandemic? the arrival of sars demonstrated the devastation that disease outbreaks impose as businesses and public facilities close in response to local, national, and international fears of disease transmission. indeed, one of the most striking differences between the two outbreaks was the administrative complexity created by the presence of competing provincial and federal authorities in . in , canada did not have a federal health department, provincial health departments were very small, and no international health agency . james lemon, toronto since : an illustrated history (toronto: james lorimer & company and national museums of canada, ), - , - , - . see also lila sarick, "visible minorities flock to city," globe and mail, february , a . sarick stated that census data indicated that % of the greater toronto area's population was visible minorities. the story noted that toronto's services and language classes were provided in many different languages and that these were under threat because of provincial plans to reorganize the education funding system. . gay abbate, "toronto board of health defies order to cut budget," globe and mail, july , a ; john spears, "budget blueprint holds line on taxes," toronto star, march , b . according to a tph budget fact sheet dated march , the department received . % of the $ . billion-dollar gross budget for the city. the $ . million allocated for tph services in was . % less than in and . % less than in . . in the british north america act, now known as the constitution act, , divided legislative powers between the federal and provincial governments. health, education, and social services were allocated to the provinces, while the federal government was responsible for national economic policy, the military, criminal law, agriculture, immigration, and only minor health duties such as immigrant inspection, quarantine, and the care of sick mariners and aboriginals. equivalent to the world health organization (who) existed. by comparing and contrasting the abilities of the two local medical health officers-drs. charles hastings and sheela basrur-to coordinate disease control efforts, develop and maintain sufficient capacity to respond to outbreaks, and communicate effectively with fellow citizens, the media, and external authorities, we will be able to gauge the impact of their activities during these crises. the parallels and differences in the two outbreaks demonstrate how the lessons of the past need to be deeply ingrained in both collective memory and public policy if present and future challenges are to be met with courage and effectiveness. - , - . had to be supported with economic arguments that demonstrated that spending on public health administration was an investment, not an expense. starting with a staff of three public health nurses in , hastings moved quickly to expand the health education component of his staff's work and in created a division of public health nurses. based in district offices shared with either the police force or social agencies, the public health nurses quickly became "guides, philosophers and friends" for the women and children in their areas. using a generalized system that stressed health education rather than curative services, toronto's department of public health (dph) devoted great attention to forging links with more than local voluntary groups through the neighbourhood workers' association (nwa). this reciprocal relationship intensified during world war i as many families received coordinated assistance from the dph and nwa as a greater emphasis on "scientific" social service developed. thus the concept of teamwork was well understood and widely shared when warnings about a flu epidemic began to arise in the spring and summer of . the influenza outbreak is thought to have begun at camp funston in kansas in march , and to have accompanied american troops to france, where it spread to the combatant armies. canadian soldiers began to fall ill during the spring, and the return of some troops during the summer of triggered the epidemic in canada. the federal government was responsible for military cases, but provincial medical officers and their municipal counterparts knew that they would be fighting the outbreak with limited resources since so many doctors, nurses, and inspectors were serving in the armed forces. on september, the toronto world reported cases in a military camp in ontario. for toronto's medical officer and its local board of health (lbh), this presented a challenge, because influenza was not a reportable disease under the ontario public health act, and most doctors were hoping that the outbreak would be similar to the one in - that had attacked primarily the elderly and apparently provided some immunity to those who survived. these hopes were soon dashed. military doctors were well aware that the flu was killing soldiers between the ages of twenty and thirty-nine with great rapidity. when the disease spread into the community, it devastated the workforce, made entire families ill, and left orphans and the elderly in its wake. but what could be done to stop it? communicable disease control was one of the main functions of municipal and provincial health departments in canada during the late nineteenth and early twentieth centuries, but in the past it had created opposition and imposed economic hardship on those who were quarantined in their homes or sent to municipal isolation hospitals. should these conventional tactics be used against the flu? as english canada's leading health department, toronto had a well-established division of communicable disease, a municipal laboratory for testing tb and diphtheria samples, an isolation hospital, and a division of vital statistics to provide the data needed for decision-making. but as hastings was well aware, the usual approach to controlling the spread of infectious disease was proving ineffective against influenza. articles in the october issue of the american journal of public health (ajph) and personal contact with health authorities in the united states made it clear to hastings, who was president of the american public health association (apha) in , and his provincial counterpart, dr. john w. s. mccullough, ontario's chief medical officer, that there was much disagreement about the benefits of these approaches. indeed, mccullough conducted a survey of provincial and state health officers on the merits of quarantine and isolation and found that the majority had concluded that "these measures are impracticable." but mayor thomas l. church, the press, and most of the public expected such actions, and in cities such as milwaukee, they were apparently effective. in toronto, however, quarantine and isolation were not implemented because the disease toll escalated so quickly as to render it ineffective on a case-by-case basis. in his capacity as president of the apha, hastings left toronto from to october to travel to boston, new york, and washington to see the ravages of the epidemic firsthand. since flu was not a reportable disease, the statistics for its spread and virulence are suspect, but each of the communities that experienced an outbreak quickly recognized its propensity to overwhelm standard disease control measures and facilities. when the disease first appeared in toronto, the moh and military authorities appealed for calm, provided a detailed description of the symptoms, strongly recommended resting in bed, and exhorted the sick to call for medical assistance. the first civilian casualty was a schoolgirl who died in toronto general hospital on september . in spite of growing public pressure for isolation and quarantine, hastings did not issue the order, because the bulk of cases were military men in the . the provincial board of health of ontario, "spanish influenza," pub. health j., , , . this item is followed on pages - by an article reprinted from chicago papers of october . chicago's health commissioner, john dill robertson, provided citizens with information from surgeon-general blue of the u.s. public health service that focused on the origin of the disease, its symptoms, and treatment. an editorial on page , entitled "influenza," reminded pub. health j. readers that there was ongoing controversy over pfeiffer's bacillus as the cause of influenza and noted that the connaught laboratories of the university of toronto were undertaking to study whether the causative agent was a filterable virus or b. influenzae and if a prophylactic vaccine were possible. base camp located in the city. but the child's death was a prelude to a typically rapid increase in cases and deaths; within a week, more than , students and staff out of the , students and , teachers were sick. the impact on the city's hospitals was immediate and overwhelming. by october, the toronto western hospital was full, and half the nurses at the grace hospital were ill. toronto general, the city's newest and largest facility, had almost % of its patients ill with flu by mid-october; eighty nurses fell ill, and three died. as a result, surgery was canceled except for emergency operations. similar problems beset the -bed st. michael's hospital, but the situation was further compounded by the absence of medical staff on duty overseas. the sisters of st. joseph used student nurses, their own teaching staff, and teaching sisters from loretto abbey to keep the hospital functioning during the epidemic. with a population of roughly , and the fear that % or more of the population would become ill if the european and american experience was repeated in toronto, the moh and his provincial counterpart moved swiftly to create additional hospital accommodation and train volunteers to care for the sick. two hotels were commandeered and turned into emergency hospitals. to staff them, the province issued a call for an ontario emergency volunteer health auxiliary that provided training to create a volunteer group known as the sisters of service. women's groups, teachers, and other women whose jobs were eliminated when their workplaces were closed attended the three-lecture course on the care of the sick and the sickroom. willing volunteers were then assigned to one of the six health department district offices or to the temporary hospitals. but as the staff at central neighborhood house, a settlement in one of toronto's slum areas, noted, few of the sisters of service were willing to serve in their part of the city. this was especially problematic for the poor and non-english-speaking immigrants because "the assistance of neighbours, usually freely rendered during illness, was negligible owing to the contagious nature of malady . . .," and this required settlement house workers to provide nursing, housekeeping, and child care during the epidemic. nevertheless, volunteer work was vital, as the public health nurses (phns) were working "to the point of exhaustion" dealing with the rapid increase in sick families. early in the outbreak, the moh informed the globe that the nurses were focusing their entire attention on assisting the sick, and that various inspectors had been put on twenty-four-hour duty to provide food, fuel, and other necessities to stricken families. according to the anonymous author of an in-house history of the public health nursing division: "as much hourly nursing care as could possibly be arranged was given, but it did not begin to cover the need. there were very few days that the nurses did not come into the district offices and relate some unbelievably harrowing stories." as the epidemic progressed, health department staff also caught the disease, and by october, of staff were ill, including twenty-two nurses and four doctors. to deal with the growing demand for nursing care and for food, fuel, and "bedding, night clothing, towels and even pneumonia jackets," the dph turned to the neighbourhood workers' association. using toronto's newspapers to publicize these needs, the nwa appealed to torontonians' patriotism and civic spirit by informing readers that any and all donations of soup, money, or volunteer time would be gratefully received and that the former would be delivered to stricken homes by boy scouts. depots to receive these items were set up throughout the city as torontonians rallied to care for the sick. the same issue of the papers reported that approximately fifty people a day were dying of flu or bronchopneumonia. the moh had already ordered schools to close, and various organizations such as the canadian and empire clubs as well as masonic lodges were canceling their meetings. the lbh and mayor church were in agreement that other places should also close to help prevent the disease from spreading, so on saturday, october, all theaters, moving-picture shows, pool and billiard rooms, and bowling alleys were closed for the duration. further precautions included prohibiting the circulation of public library books while allowing the libraries to remain open, and persuading toronto's churches to hold only a single service on sundays-mass for catholics in the morning, and evening services for protestants. the university was closed, and fifth-year medical students were assigned to assist busy general practitioners in making home visits and to work in the newly opened temporary hospitals. the health department also relied on the work of the victorian order of nurses and the st. elizabeth visiting nurses for bedside care of the sick. during the epidemic, the health department staff made , visits to stricken households, and its records indicate that there were approximately , deaths in , cases. the latter is probably an underestimate, given the extent to which the press of work prevented accurate reporting of cases and deaths. as well, the military was compiling its own statistics in the base hospital located in the . ibid. . "university classes cancelled," the toronto world, october , . the news story stated: "all students in the faculty of medicine are asked to volunteer their services to fight the epidemic." . "victorian order of nurses," pub. health j., , , . the von usually cared for maternity cases, but their small staff of eighteen volunteered to care for the sick during the flu epidemic. the st. elizabeth visiting nurses performed similar duties for catholic torontonians. . marion royce, eunice dyke: health care pioneer (toronto: dundurn press, ), - . can. j. med. surg., , , states that toronto suffered , deaths from influenza and , from pneumonia, for a total of , , which was , in excess of the normal october death rate of . . "the provincial board of health of ontario," pub. health j., , , noted that since influenza was not a reportable disease, "the only means we have of getting anywhere near the deaths caused by the epidemic is from returns made by undertakers . . . ." the result was an ongoing recalculation of the provincial morbidity and mortality rates as new information arrived. by , mccullough had concluded that ontario had experienced roughly , - , cases, with , deaths. eastern part of the city and at the base camp at the exhibition grounds. whether these were included in the city's tally is unclear. but the impact of the epidemic was profound. the newspapers contained short items noting the deaths of many specific individuals, advertisements apologizing for delays in delivering bread and milk, news stories describing board-of-health meetings and the actions that resulted from its deliberations, and hortatory calls for more volunteers. the world also printed an impassioned plea arguing the benefits of gauze masks and asking that "[e]verybody wear a mask to work on saturday morning." neither hastings nor mccullough felt that wearing masks in public was warranted, with the result that ontarians were not required to use them as were their counterparts in alberta and several u.s. states. the economic consequences of the epidemic were significant. munitions plants and other war industries slowed as workers became ill. the municipal firefighters and policemen took sick, as did trainmen and bell canada employees. the cold rainy weather added further stress to the epidemic when coal became difficult to obtain and fuel supplies for the sick and for industry diminished. in a society that lacked unemployment insurance, the task of responding to the needs of the sick and their families fell on a populace that had already donated its time, effort, and money to winning the war and buying victory bonds. nevertheless, the toronto board of trade created an influenza fund and worked with the nwa and other community groups to distribute the proceeds. by the beginning of november, the situation began to ease. the schools were supposed to open on november, but the fuel shortage postponed the reopening for a week. sporting events resumed, hospitals began to report empty beds, and on november the armistice was signed. the celebrations that this unleashed may have contributed to another wave of the flu, but for charles hastings, the epidemic revealed a crucial lesson: we require the centralization of authority. whether that be a public health service, a local government board, a department of health, a ministry of health or a secretary of health, it matters little, but all authority should be centralized under one department, if we are going to have efficient results. every human body may be a battlefield against these invisible foes. consequently, every individual must be trained a fighter, and though we march apart, we must fight together under one command. to his canadian counterparts, hastings was clearly calling for the creation of a federal health department, and in march , legislation to this effect was introduced. the ravages of the flu epidemic were cited as one of the factors justifying the extension of federal involvement in an area of exclusive provincial jurisdiction. but the real impact was at the provincial and municipal levels. in toronto, hastings and his staff had demonstrated the benefits of a well-organized department that had made links to other municipal services, local hospitals, and non-governmental organizations. their experience enabled them to move quickly to take command in a crisis situation. the role of provincial authorities was somewhat more complex. as chief medical officer (mo), lieutenant-colonel john w. s. mccullough had responsibility for all parts of the province that lacked permanent public health staff, but he was also deeply involved with his military duties. the solution was to allow hastings and his staff to demonstrate effective community engagement and then to use this model for the rest of the province. when standard disease control measures proved ineffective at stemming the rising numbers of cases, hastings turned to prevention. lessons from history," in which she reminds her readers that we still do not have an effective treatment for influenza, and that we too should use early twentieth-century techniques of providing information and immediate closure of all but essential services to ensure that "when our time comes, we will be able to match the intelligence, energy, coordination and cooperation of our forebears." see www.cmaj.ca/cgi/content/full/ / / / dc for the full text. he brought back a b. influenzae-based vaccine from his visit to the new york city laboratory to start flu vaccine production in toronto. most civilian and military health officers pinned their hopes for controlling the epidemic on either a preventive or a prophylactic vaccine. in the connaught laboratories had opened in toronto to produce diphtheria antitoxin, but it quickly became the main supplier of vaccines for the war effort. during the flu epidemic, dr. r. d. defries, the acting director, undertook the production and testing of flu vaccine using eighteen strains of the new york source and additional ones from canadian soldiers at the base hospital. although he was impressed by the impact of the vaccine on "desperate cases," he was alert to growing evidence that the vaccine was ineffective because researchers were unable to demonstrate that the pfeiffer bacillus was the cause of the disease and indeed had begun to argue that it was a filterable virus instead. defries later argued that "[t]he preparation and trial of vaccine was fully warranted by the existent knowledge of the disease and its etiology," while hastings commented in november that during the flu epidemic the medical profession was "severely censured for not having discovered a vaccine," indicating that the public too expected science to provide a preventive for the disease. but as many of the reports published in canadian and american medical journals indicated, there was little clinical evidence that preventive or prophylactic vaccination made a difference. and what about the citizens? one of the most striking features of the outbreak was the extent to which torontonians of all social classes suffered and yet sought to help each other. the middle class and well-to-do volunteered themselves and their cars to take food, medical and nursing supplies, and doctors and visiting nurses to their patients. workers tried to maintain essential services while their customers faced a final round of privation prior to the end of the war. teachers, homemakers, and nursing, medical, and dental students volunteered their services in hospitals and in the community. settlement workers noted that the poor were so severely affected that they were unable to provide assistance to their neighbors-a breach of customary practice. and various immigrant groups were presented with additional challenges, as the information provided in pamphlets and local newspapers had to be translated into languages they understood. as the anonymous scribe who wrote about public health nursing noted: "the epidemic lasted approximately two months and it was an unforgettable experience for us all." for the health authorities who had directed local and provincial or state efforts during the epidemic, the influenza outbreak provided a challenge to their authority and expertise that led figures such as sir george newman and victor c. vaughan to lament the inability of officials to either control or prevent the disease. at the rescheduled annual apha meeting in chicago in december , a committee was formed to prepare "a working program against influenza," which was published in the january issue of the apha journal. this comprehensive review of the strengths and weaknesses of the efforts to combat the disease justified its prescription for action by noting that health agencies "must act in light of present knowledge," even if that knowledge is limited or flawed. but it is clear that there were many variables that affected the progress of the disease, and that finding the cause and an effective vaccine was high on the medical community's agenda. for local health officers, however, the extent of public cooperation during ironically, the support that toronto's health department had received in proved limited. as the city returned to "normalcy" in , the mayor and board of control recommended budget cuts to municipal services, including the health department. the effective organizing and yeoman services that staff had performed during the flu epidemic were forgotten or ignored when a mild form of smallpox appeared in october . anti-vaccination groups organized rallies attended by some city council members who objected to hastings's dynamic leadership and his demand that mandatory vaccination be instituted. this well-established preventive measure was condemned as "german born compulsion" and rejected as antithetical to the principles of liberty and democracy for which the war had just been fought. were the anti-vaccinationists reflecting concern at the inability of the medical profession to prevent the flu epidemic through immunization, or was their opposition to compulsory vaccination a postwar rejection of the social and moral authority of progressive experts and their domination of the war effort? from to , municipal and provincial health departments continued to be legally responsible for control of communicable disease. but with the development of vaccines against childhood diseases, the eradication of smallpox, and the use of antibiotics to treat tuberculosis and sexually transmitted diseases, the war on disease appeared to be won. as attention and staff interest shifted to behavior modification and encouraging community development, the financial resources and personnel devoted to disease surveillance, infection control, and isolation/quarantine diminished. instead of tb sanatoriums, preventive measures, and mass chest screening and tuberculin testing, for example, the communicable disease control (cdc) unit in toronto was using directly observed therapy against a resurgence of tuberculosis in the late s. but would this client-specific approach prove effective against a future pandemic? what role would municipal health departments be expected to play in the event of such outbreaks? experts and pundits began to warn about the possibility of a worldwide pandemic of influenza during the s and s, in the wake of the and - of tuberculosis, followed by human deaths from avian flu, was coupled with growing concern about environmental degradation. in ontario, the pathogenic outbreak of e.coli as a result of water contamination in walkerton demonstrated the price that communities paid for failing to maintain basic services. a commission chaired by justice frank o'connor highlighted the effect of provincial government cuts to the ministry of the environment and noted that it had failed to share vital information with local and provincial health authorities. during the harris regime from to , the provincial government pursued tax cuts and reorganization of provincial services that focused on downloading duties to municipalities and regional governments. convinced that toronto and its surrounding cities-scarborough, north york, the borough of york, east york, and etobicoke-were duplicating services, the province compelled them to amalgamate in . this meant that the toronto health department had to incorporate staff from the other five municipalities, determine whether its programs and services were appropriate to the new city, and try to find economies that would assist the new city's budget committee in dealing with its declining revenues. the new moh, dr. sheela basrur, was a graduate of the university of toronto (m.d. , mhsc. ) who had been the moh of the east york health unit, which had approximately fifty employees. in she became the leader of over , staff, serving a population that was significantly different from its historical roots. in addition to expanding in terms of territory, the new city had a multi-ethnic population that included . % east and southeast asians, . % south asians, . % west asians, . % africans, % caribbeans, % north americans, . % british, and % aboriginals. fortunately, toronto health had been hiring community workers from the various ethnic groups since the s in recognition of the need to provide culturally sensitive approaches to health education and preventive services. but would toronto public health, as the new entity was known, be able to maintain its national and international reputation for innovative community-responsive public health services in the face of the province's mandatory programs and limited funding? the election of the progressive conservatives led by mike harris compounded the financial difficulties already facing toronto public health as a result of the recession of the early s. the harris regime was committed to cutting government spending and staff, dismantling publicly owned utilities, remaking the public education system, downloading as many social service and welfare activities as possible, and privatizing certain environmental and health services. for tph, staff cuts, program closures, and the pressure to reorganize and redefine future goals meant focusing on children, families, and specific "high-risk" groups such as hiv/aids victims and street people rather than expanding cdc activities. in addition, the city's many acute-care hospitals and long-term-care facilities were struggling to maintain service levels because of funding shortfalls and declining numbers of staff. a widespread flu outbreak in the winter of had resulted in the deaths of several citizens who had not received prompt assistance in overcrowded emergency wards. as a result, the province introduced mass flu vaccinations in the fall of . the immunization program was offered free to citizens through public clinics or their family physicians. but would this voluntary program be sufficient to protect torontonians from the feared pandemic? health canada had been attempting to develop a national flu pandemic program, but ontario was not supportive, preferring to develop its own approach, since the harris conservatives were engaged in an ongoing conflict with the chrétien liberals over which level of government had the authority to design health to alert them to this possible problem. by march, however, the tuberculosis test was negative, more people were sick, and infection-control experts at other toronto hospitals were working with tph to identify the new disease. on march, the world health organization had issued a global alert announcing outbreaks of atypical pneumonia in hong kong and hanoi, and this enabled tph and dr. allison mcgeer, an infectious-disease specialist at mount sinai hospital, to identify the mystery illness. "in consultation with provincial and federal health officials, tph held a press conference on march , activated its emergency response plan, established a public information hotline and assigned staff full-time to the outbreak investigation." this succinct statement fails to convey the sense of crisis that existed as all three levels of health authorities discovered the weakened state of communicable disease control measures. for more than fifty years, tph had not imposed quarantine on its citizens, and although the provincial health promotion and protection act contained provisions to do so, tph staff lacked recent experience. even more challenging was the lack of knowledge regarding the disease itself. what was its cause? how was it spread? where was it most likely to be contracted? what was the incubation period? how should it be treated? who should be responsible for informing the public, provincial and federal authorities, and the who about suspected and probable cases? the sars outbreak starkly revealed the lack of coordination between federal and provincial health officials, and this conflict added to the demands being placed on tph staff when they found themselves providing the same information to two different sets of officials. differences of opinion about the confidentiality of patient information further challenged tph containment efforts, since they needed names of contacts to determine who should undergo a tenday quarantine. in contrast to , when there had been a united front against influenza, the sars outbreak illustrated the gap between prevention at the community level and care in hospitals or other tertiary facilities. the situation was further complicated because of international air travel and the growing demand for preventive precautions at pearson international airport, located in mississauga, outside the bounds of tph's jurisdiction. with virtually no scientific information to guide them at the start, and confused lines of communication with senior governments, basrur and up to of her staff began to track cases, monitor contacts, provide infection-control advice to long-term-care facilities and hospitals with sars patients, and respond to growing public concern about the extent and nature of the outbreak. in addition to its printed materials, the tph website posted descriptions of the symptoms as well as guidelines on hand-washing and quarantine procedures in fourteen languages. more than staff did daily double shifts from a.m. to p.m. on the sars hotline, which received over , calls during the outbreak, , in a single day. although staff worked diligently, they were aware that the fragmentary information they provided early in the outbreak caused frustration for many callers. as justice campbell commented: "the problem was not lack of dedication and effort, but the fact that it was impossible in the middle of a rapidly expanding crisis to create the necessary infrastructure." nevertheless, in recognition of the ethnic diversity of the city and the origins of the outbreak, tph worked closely with the chinese community, which had created a community coalition concerned about sars. this group trained chinese-, mandarin-, and cantonese-speaking volunteers to staff a hotline (the numbers sound like the chinese word for "i'm willing to help you"), produced and distributed chinese-language sars material, did promotional activities for hard-hit chinese businesses, and raised research money for sars studies. during the course of the outbreak, tph's case management team was involved in , investigations that required consultation with infectious-disease specialists because the symptoms were atypical and no diagnostic test was available, even though the genetic sequence of the coronavirus was established by british columbia's michael smith genomic sciences centre on april. the lack of clear diagnostic criteria complicated control procedures because tph staff and their clinical colleagues were aware of the stigma attached to the disease and of the danger of missing a case. to compound their difficulties, technology failed at this critical moment. when the outbreak started, the only available diseasereporting system was a fourteen-year-old dos-based one known as rdis (reportable disease information system). it was quickly apparent that this disease-specific program would not work, and tph turned to paper files with post-it notes to keep track of cases and their contacts. within two weeks excel spreadsheets were also in use, but at no point was the technology sufficiently flexible to provide the type of information and analysis that would have enabled a clearer picture to emerge. the challenge of contact tracing and quarantine supervision was immense, as over , people were identified as contacts in each of the two waves of the disease and , spent ten days isolated in their homes. while they were in quarantine, staff from tph phoned once or twice a day to see if they had any symptoms and to find out if emergency food supplies from the salvation army or canadian red cross were required. in spite of frustration caused by having to review their situation with each tph staff member who contacted them, very few torontonians refused to comply with voluntary quarantine procedures. only twenty-seven isolation orders were issued during the outbreak. , , - , in which torontonians and health care personnel who had been quarantined reported that they had complied with quarantine requests "to reduce the risk of transmission to others," to protect community health, and because they saw it as their "civic duty." fear of legal consequences had little influence in the decision to undergo the hardship that ten days in isolation imposed. in a post-outbreak survey of health care workers and the general population who had been isolated, an american organization discovered that respondents cited "protecting others" as their main motivation for undergoing quarantine. this strong sense of personal and collective responsibility for community welfare mirrors the dedication of visiting nurses and volunteers during the flu epidemic. the good behavior by the general public may have stemmed in part from the growing recognition that sars was apparently a nosocomial infection. the outbreak was confined mainly to hospital staff, patients, visitors, and family members who had close contact with the index cases. but in response to growing concern about sars spreading more widely, the ontario government declared a state of emergency on march and ordered all of toronto's hospitals to move to code orange emergency procedures. as in , this resulted in the cancellation of all surgical procedures, limited emergency access, and the cancellation of appointments and elective procedures. all visitors were banned, including families seeking to care for dying relatives. four days later, this draconian measure was applied to the province in general to protect health care workers and to prevent the spread of sars into the general population. by the middle of april, the number of new cases was declining and health authorities began to think that the worst was over. . chapter of learning from sars describes the "quest for containment" between april and april, - , and notes that the media highlighted each story about possible community spread, leaving the impression that tph and provincial authorities were not doing their jobs effectively. provincial officials and hospital spokespeople had issued daily reports on the number of actual, probable, and suspected cases and provided the media with information to calm public anxieties over the easter and passover holidays. as in , religious groups were asked to use common sense and to avoid shaking hands, kissing, sharing common communion cups, and organizing large gatherings, including funerals. but as post-outbreak studies indicated, the mixed messages that the daily briefings provided did not convince external observers that the situation was under control. april the ban was lifted, but the international publicity and the continuing cancellation of conferences and conventions meant that toronto's economy was suffering greatly. the loss of jobs in the tourism and hospitality industries added to the stress, and the civic and provincial governments turned to marketing campaigns in an effort to reassure torontonians and visitors that the city was safe to visit. during late april and early may, staff from north york general hospital sought advice from tph regarding possible sars cases in the psychiatric ward and among elderly post-operative orthopedic patients. since none of these people could be linked epidemiologically to previous cases, the situation remained in flux until an icu nurse from north york general was admitted to the toronto western hospital with sars. in the interim, possible sars patients had been transferred to st. john's rehabilitation hospital and the baycrest centre for geriatric care. the province announced publicly that a second wave of the disease had appeared on may, and the criticisms of all the flaws and failures that external critics had been making about the city's inability to control the disease increased in volume. prime minister jean chrétien had already appointed a national commission led by dr. david naylor, then dean of medicine at the university of toronto, to investigate the outbreak, and now the ontario minister of health, tony clement, announced the creation of an expert panel on sars and infectious disease chaired by dr. david walker, dean of medicine at queen's university in kingston. and finally, on june, ontario's then-premier, ernie eves, named justice archie campbell to head a judicial commission to take testimony from patients, families, health care workers, and their representatives. these reviews made sars one of the most intensively studied disease outbreaks in canadian history, and the naylor, walker, and campbell reports all stressed the lack of coordination, capacity, and communication that bedeviled federal/provincial/municipal relations in ontario during the crisis. on june, the first nurse to die in the outbreak perished. her death was followed by that of a colleague on july, and by that of a family physician on august. out of the national total of cases, toronto had , with deaths. twenty-nine nurses, fourteen doctors, and thirty other health care workers, including respiratory therapists, radiology and ecg technicians, paramedics, registered assistants, housekeepers, clerical staff, and security personnel, suffered from sars, and many are still trying to recover. in comparison to the morbidity and mortality of the flu, these numbers may seem small, but a century of medical progress had conditioned the public and health care workers themselves to expect medical professionals to provide prompt diagnoses and effective cures. the apparent speed with which sars could spread and the . kylie taggart, "independent sars commission set up in ont.," med. post, , , . in this story, taggart notes that a ninety-six-year-old man who died at nygh was thought to be the index case for the second sars wave: a health care worker on the same floor may have contracted sars from her mother, who had been a patient in the scarborough grace hospital. . learning from sars, chapter , , . according to mark hume's article, "in search of a sars vaccine," china experienced , cases, with deaths, and was leading in the race to produce a vaccine against sars. worldwide, the disease infected , people in countries and killed , including the in toronto. . terry murray, "health-care staff have a 'duty' to treat," med. post, , , . lack of provincial laboratory support for diagnostic purposes left toronto health reliant on volunteers from other health units in ontario and medical researchers based in the city's hospitals for the information that it needed to determine whether individuals were at risk of contracting or spreading the disease. when experts like allison mcgeer became ill with sars, not only was there concern for her, but the experts with whom she had been consulting had to undertake ten days of quarantine during the height of phase one. the colleagues who cared for them, as well as the public health staff who supervised quarantine activities for their families, will never forget the stress that this outbreak brought. and authority. gradually, informal links with nearby health units emerged, as sars spread beyond toronto and york county into the peel and durham regions, but the shared sense of camaraderie that marked did not materialize, because there had not been the type of sustained contact and trust-building that had occurred in toronto from [ ] [ ] [ ] [ ] [ ] . both outbreaks demonstrated the logistical and political challenge that contagious diseases pose to local public health administrators. in , hastings and mccullough knew that their plans would be overset by lack of personnel. but they also knew that they could call on willing volunteers for support, and that the mayor and local board of health backed them. almost a century later, toronto public health had to people working in its communicable disease control section, but they were dealing with an unknown disease that quickly uncovered the gaps in existing procedures for infection control in public institutions. although tph staff had worked with the seventy-eight long-term-care facilities in the city to ensure that their infection control practices were effective, they had not provided the same level of service to acute care hospitals, because of budget cuts and because there were supposed to be infection control officers and committees in place. as a result, the trust that enabled hastings and mccullough to rely on their academic and hospitalbased colleagues for curative services did not exist, and tph moved to create effective relationships with toronto hospitals by establishing a communicable diseases hospital liaison unit. this was fully funded by the province from june to march , with a commitment for % funding thereafter. but as the toronto star reported, city bureaucrats think that unless the province pays the entire cost, the city should scrap the unit. not surprisingly, tph has argued that this unit is a critical part of future disease control efforts if a seamless transition from preventive to curative services is to be provided. in both outbreaks, communication was a vital part of the moh's role. in october , hastings responded promptly to press queries, relying on his well-established ties with various newspapers to ensure that a message of calmness and fortitude was presented. the extent of the epidemic meant that many reporters, typesetters, and delivery boys were among the ill, with the result that the official view was rarely questioned. as well, stories about the final days of the first world war occupied many readers' attention. in , the local press was initially very supportive and provided excellent summaries of existing knowledge regarding symptoms and where to seek help. the nightly news included the daily press conferences attended by senior provincial officials, local infectious-disease specialists, and dr. basrur. her calmness throughout the crisis had an impact, according to one toronto hospital's administrative assistant: "when the medical officer of health gets on tv and says everything is ok, we believe her." unfortunately, the information provided by hospital-based specialists and provincial authorities seemed to contradict the moh's steady confidence in her staff and their activities. as the naylor, walker, and campbell reports suggest, this approach was ultimately perceived as indicating a lack of leadership and a possible attempt at covering up the extent of the outbreak. in retrospect, a single spokesperson would have been advisable, but there was little that any of the officials could do to overcome the voracious appetite of the media for information. the information and misinformation that was broadcast internationally undoubtedly contributed to the who travel advisory and to the decline in tourism and convention business. as a result, politicians at the provincial and federal levels tried to demonstrate their faith in the disease control efforts by tph and its supporters by having widely publicized meals in chinese restaurants. gallant as these attempts to jump-start toronto's economy and promote solidarity with potential voters were, they did not mask the underlying tension between the two levels of government. tph was caught in the middle because it was the body that had to help people qualify for federal employment insurance, provide food and other necessities while they were in quarantine, and respond to all the calls for information that flooded the hotline. perhaps the most difficult ones to deal with were those asking for assistance in avoiding ethnic stigmatization. with its origins in china, sars provided critics of canadian immigration policy with a platform from which to vent their concerns. but the april outbreak among a charismatic filipino religious group meant that they too were treated with hostility and fear. as previously noted, nineteenth-and twentieth-century epidemics were replete with racist critiques directed against the presumed human vectors of diseases such as cholera, typhus, and plague. even aids prompted a similar response because of the high morbidity rate within the haitian community. but one of the striking features of the sars outbreak was the uniform condemnation of racist epithets by politicians, reporters, and concerned members of the public. and when it became clear that sars was predominantly hospital-based, health care workers also found themselves socially isolated. each of the official reports commented on the sense of "fear, anger, guilt and confusion" that health care professionals felt as they tried to protect themselves and their families from the disease and from the fear evinced by their fellow citizens. even more perturbing was the rift that appeared when provincial public health experts suggested that some of the in-hospital transmission occurred because of lack of hand washing, lack of proper use of n masks, and lack of common sense about staying home if symptomatic. a team from the centers for disease control and prevention in atlanta was invited to toronto to adjudicate this dispute, but well after the outbreak was over, it was revealed that very few of the n masks had been properly fitted. little wonder that hospital-based nurses who appeared before each of the commissions of inquiry were vehement in their criticism of the way the outbreak was handled. for these frontline workers, the sars outbreak demonstrated once again the gap between theory and practice in clinical settings and the continuing hierarchy that privileged medical rather than nursing and other staff. a century of evolution in professional identities and status expectations was laid bare by sars. in , flu was a known disease whose virulence seemed unaccountably to have mutated to the point that it became lethal. sars was an unknown virus whose incubation period, degree of virulence, symptomatology, treatment, and sequelae were determined through experience and monitoring events in hong kong, singapore, hanoi, and other stricken centers. in both instances, local public health agencies were the principal agents of the state because they provided the organization and staff to conduct casefinding home visits, arrange contact tracing and quarantine measures, and organize hospital accommodations for the seriously ill. these standard disease-control measures were overwhelmed by the magnitude of the epidemic, but the volunteer efforts of many citizens meant that the supportive care needed to prevent flu sufferers from succumbing to pneumonia and other sequelae was available. in , the unity of purpose that had linked toronto's health department, city hospitals, and the neighbourhood workers' association no longer existed. the hospital sector dominated much of the press coverage, and the cleavage between provincial officials and nurses' unions became widely known as a result. "name, blame, shame" replaced the deference to authority that had marked early twentieth-century news reports. nevertheless, the work of tph staff was recognized by international experts, and on july , mayor david miller presented dr. barbara yaffe, the acting moh, and frontline staff with the canadian public health association certificate of merit award for "their exceptional contribution in managing the sars crisis" by "controlling the outbreak and implementing one of the largest quarantines in modern history." such recognition from peers and colleagues across the country is welcome confirmation that in spite of all the flaws and failures, toronto public health fulfilled its obligations. and in his second interim report, justice campbell argued for the primacy of local and provincial medical officers, stating that they "must have the lead role in public health emergency mitigation, management, recovery, coordination and risk communication." when the sars outbreak began, reporters looked for parallels and historical models. the flu epidemic was cited by epidemiologists and historians as a possible parallel, largely, one suspects, because it has recently been the subject of renewed research and because it was worldwide. but was there perhaps another reason? were reporters and newscasters seeking reassurance that all would be well and that civilization would survive? in the western media, attention was divided between the war in iraq and the sars outbreak. in the twenty-first century, death in combat seems somehow more comprehensible than death from disease. but as environmental degradation proceeds and species-jumping viruses and bacteria multiply, the certainties that pervaded twentieth-century western medicine are beginning to fade. in their place is increasing respect for the ability of microorganisms to mutate and a determination to use all available scientific tools to combat threats to human health. to date, three vaccines have been developed against sars; the sino-european project on sars diagnostics and antivirals has reported that cinanserin, a drug for schizophrenia, is a useful therapy; and dr. josef penninger's research team has demonstrated that the protein ace can be used to combat the fluid buildup that killed sars patients. clarifying the clinical picture and finding effective medications may remove the fear that epidemic diseases create, but, as this review of disease control activities has demonstrated, age-old methods such as case identification, contact tracing, quarantine, and isolation are the first stage of containment and hopefully eradication. toronto's experiences in and demonstrate "the power of public health" as the bedrock of disease control efforts. but is it the historian's responsibility to point out the "lessons of the past"? if so, to whom should her observations be addressed? policymakers and public health administrators will be using the recommendations of the three reports as the foundation for change, and indeed, the federal government has already created a junior minister of state for public health, while ontario, under its new liberal government, has promised $ . million over the next three years to create the ontario health protection and promotion agency. dr. sheela basrur has been appointed the new chief medical officer of health, and the powers of the position have been expanded to enable future planning and better coordination. does this signal the senior governments' recognition of the crucial importance of prevention? has the balance of power within the biomedical world shifted, or will the sars outbreak fade from memory as quickly as the events of ? these questions will challenge future historians to explain the long-term impact of epidemic disease on society and to analyze the role of local health departments in the ever-expanding war on disease. the modern conception of public health administration causes of poverty the policy, spirit and programme of the neighborhood workers association america's forgotten pandemic some observations on the recent epidemic ´enlightening the public': the views and values of the association of executive health officers of ontario, - plague: a story of smallpox in montreal state medicine in transition: battling smallpox in ontario the value of a credit balance in public health administration doing good: the life of toronto's general hospital for the least of my brethren: a centenary history of st. michael's hospital (toronto and the control of influenza in ontario crossed wires put toronto on hit list disease is damaging ontario's economy, cabinet officials say first, tell the real story cutbacks fed sars calamity, critics say public-health spending cuts went too far, critics say fear factor: so just how big a risk is sars? what made the statement more surprising is that pat green's husband was a toronto firefighter and her son, derek, was a toronto transit commission bus driver, indicating that all three of them were in occupations that would be at risk if sars had been spreading in the community the learning from sars report estimated that sars would cost canada two billion dollars, while the former ontario auditor, erik peters, stated that sars-related spending by the provincial government would cost $ million, only $ million of which would come from federal coffers. see justice campbell's interim report-sars and public health in ontario, appendix e: the economic impact of sars. pestilence and restraint: haitians, guantánamo, and the logic of quarantine countless health care workers faced a fundamental conflict between self-preservation, and a professional obligation to serve the greater good nurses have long voiced concerns that their knowledge and experience is not taken seriously by senior decision makers. at north york general hospital, nurses alleged that administrators ignored their warnings of an impending second sars outbreak , , quotes dr. mark lipsitch of harvard university, who stated that "tph did a very good job under completely uncertain circumstances second interim report: sars and public health legislation killer viruses sars link to acute lung failure discovered in laboratory mice as a result of experience during the sars outbreak and growing concern about a future influenza pandemic, all three levels of canadian government have created pandemic influenza plans. see www.health.gov.on.ca for information on the ontario plan and its links to the federal plan key: cord- - v anfbo authors: nan title: correction to: oral cancer patients date: - - journal: br dent j doi: . /s - - - sha: doc_id: cord_uid: v anfbo author's correction note: letter to the editor br dent j ; : .the second author was inadvertently omitted from this letter. the authors were both n. al-helou and l. gartshore. sir, it is welcome news that the prime minister is taking the issue of obesity seriously. conservative dentists believe now is the time to bring dentists in from the cold, to join forces with our medical colleagues and battle obesity. obesity was a problem before the pandemic but we know now that covid- hits obese people disproportionately hard and that countries with high obesity rates from western europe to the us have struggled to keep people alive in intensive care units. one in four people in the uk who have died from the virus also had diabetes, and according to the latest nhs figures obesity is understood to account for - % of the risk of developing the condition's type incarnation. almost % of adults in the uk are classed as obese, which puts increased metabolic demand on one's body; more energy and oxygen are required. when a person suffers with severe obesity, their immune system works overtime and this alongside the exaggerated inflammatory response that commences - days after covid- symptoms first appear, is what has killed a lot of patients. obesity is a complex health issue resulting from a combination of contributing factors but numerous studies indicate an association between oral health and a variety of general health conditions including obesity and diabetes. oral health has been isolated from traditional healthcare and policy discussion, despite it being the third most expensive health condition behind diabetes and cardiovascular disease. for a lot of patients, their dentist will be the most regularly visited healthcare clinician. with their medical background, dentists, hygienists, therapists and their dental teams, who have fought a long battle against sugar, are well placed to deliver overall health messages and so reinforce the relationship between diet, excess sugar and overall health. the healthcare advice that leads to a healthy oral cavity leads to better overall health and a reduction in sugar intake underpins a stronger immune system. early interventions using a more coordinated approach between healthcare teams to tackle these related conditions would lead to more efficient resource allocation and be more effective in achieving positive health outcomes. s unfortunately, dental services for in-patients fell victim to one of the early cutbacks in nhs funding in the s. it is surely time to revisit this aspect of holistic care neglected for far too long. sir, i read with great interest the paper by i. w. hashem et al. as the dental care of hospital in-patients has long been a concern of mine. back in the s i was employed as in-patient dental officer at guy's hospital where my duties were to look after the dental care of hospital in-patients. a large part of my work included pre-operative assessment and treatment of cardiothoracic patients and dealing with dental emergencies when they arose not just at guy's but also at the associated hospitals and care homes in the guy's group. i had a stand-alone surgery in the main hospital and a dental nurse to assist me. informal seminars were also given to nurses about the importance of the oral health of patients in their care. in this time of enormous pressure on the nhs utilising the expertise of the dental team would help relieve the stresses on the hard-pressed medical and nursing staff engaged currently in their battle against covid- and in the long term improve patient care without adding to the burden on the already over-stretched doctors and nurses. correction to: high aerosol generating potential dental care pathways for adult inpatients in an acute hospital: a five-year service evaluation health policy: hospital cutbacks the original letter can be found online at https://doi.org/ . / s - - -x. key: cord- -efxh grs authors: gostin, lawrence o.; tomori, oyewale; wibulpolprasert, suwit; jha, ashish k.; frenk, julio; moon, suerie; phumaphi, joy; piot, peter; stocking, barbara; dzau, victor j.; leung, gabriel m. title: toward a common secure future: four global commissions in the wake of ebola date: - - journal: plos med doi: . /journal.pmed. sha: doc_id: cord_uid: efxh grs lawrence gostin and colleagues offer a set of priorities for global health preparedness and response for future infectious disease threats. • system-wide accountability is vital to effectively prevent, detect, and respond to future global health emergencies. • global leaders (e.g., united nations, world health assembly, g , and g ) should maintain continuous oversight of global health preparedness, and ensure effective implementation of the ebola commissions' key recommendations, including sustainable and scalable financing. the world is becoming increasingly vulnerable to pandemics resulting from globalization, urbanization, intense human/animal interchange, and climate change. a series of global health crises have emerged since , ranging from severe acute respiratory syndrome (sars) and its phylogenetic cousin middle east respiratory syndrome (mers), to pandemic influenza a (h n ), ebola, and the ongoing zika virus epidemic. the ebola epidemic gave rise to four global commissions proposing a bold new agenda for global health preparedness and response for future infectious disease threats [ ] [ ] [ ] [ ] [ ] [ ] [ ] . in response to critiques of who's performance during the ebola crisis, the world health assembly (wha) approved an advisory group on reform of who's work in outbreaks and emergencies, which reported in january . the wha also approved a review committee on the international health regulations ( ) (ihr), due to report in may [ ] . the commissions were established to critically evaluate the national and global response to ebola and to enhance preparedness to prevent, detect, and respond to future infectious disease threats. each commission had its own membership and funding described in s table, but had similar mandates to improve global health security. given the major threat posed by infectious diseases, these panel reports should drive the agendas of the wha and the g summit in , and global leaders should then maintain heightened oversight of global health preparedness going forward. pandemics pose a significant risk to security, economic stability, and development. the cghrf estimated annualized expected losses from pandemics at $ billion per year-$ trillion in the st century-yet the global community has significantly underestimated and under-invested in pandemic threats. cghrf recommended an annual incremental investment of $ . billion- cents per person-to strengthen global preparedness. this modest investment would provide a major security dividend. this article focuses on three major reform dimensions-national health systems, global governance, and research and development-and offers a set of priorities drawing on the findings of all four commissions. s and s tables compare the four commissions' reports along these dimensions. to make the world safer, we need robust health systems; an empowered who, with strengthened response capacities; a well-funded and planned research and development strategy; and system-wide accountability. robust and sustainable health systems are an indispensable prerequisite for health security. the ihr-the governing framework for managing infectious disease outbreaks-requires states parties to develop and maintain core health system capacities to detect, assess, report, and respond to potential public health emergencies of international concern (pheic) [ ] . core capacities include a health workforce, laboratories, data systems, and risk communication to identify and contain threats before they cross national borders (fig ) . the initial target date for establishing these capacities was june [ ] . who has traditionally measured national health capacities by allowing states to conduct annual self-assessments. most states, however, missed the initial reporting requirement for meeting ihr core capacities and, in , who extended the deadline to for all states that requested extensions. of the states required to report, only states reported meeting core capacities, representing a compliance rate of just over %, while failed to even respond [ ] . this low level of compliance for meeting minimum core capacity standards may be an overestimate because self-assessments are unreliable without independent validation. table highlights the commissions' recommendations to develop and assess core capacities. the who took an important step in february , developing a joint external evaluation tool to evaluate ihr capacities every years, with national and international subject experts reviewing self-reported data, followed by a country visit and in-depth discussions. each country's assessment will be made public, with a color-coding scheme to delineate implementation levels for each capacity [ ] . until governments achieve a high degree of compliance with ihr obligations, however, who should plan more frequent external assessments, rather than waiting years between assessments. participation of stakeholders in the community should also be a critical component of assessments. a major weakness of who's new mechanism for monitoring the core capacities of states is that it is voluntary, reflecting state sovereignty concerns. ensuring compliance with ihr obligations, even with better reporting, requires creative incentives, technical and financial support, and transparency. table highlights the commissions' recommendations on financing and incentives towards ensuring countries report their core capacities and meet their minimum ihr obligations. the international monetary fund (imf) could encourage countries to participate in ongoing evaluations by incorporating pandemic preparedness into its evaluation of macroeconomic stability [ ] . imf assessments offer a powerful inducement given their influence over countries' access to capital. similarly, the world bank's pandemic emergency facility-along with regional development banks-could condition disbursements based on governments meeting ihr obligations. political leaders are more likely to cooperate if they view external evaluations as a pathway to funding and technical support. consequently, who should not simply give countries a pass/fail grade; rather, it should constructively partner with governments. core capacity financing, however, requires the international community to close an investment gap of $ . billion per year [ ] . who and the world bank should develop a financial plan, with targets for national and international contributions. additional financing mechanisms could be modeled on the global fund, with the world bank and who hosting periodic donor investment and replenishment conferences. the global health security agenda (ghsa), a partnership initiated by the united states encompassing nearly countries, which was set up to prevent, detect, and respond to future infectious disease outbreaks, could offer a model for strengthening health systems [ ] . ghsa, with >$ billion in funding, has developed "action packages," where priority technical areas are identified, with each encompassing a target and action items, along with baseline assessment, planning, and monitoring activities, and capabilities evaluated through a peer assessment process [ ] . ghsa, however, formally stands outside the ihr framework, thus lacking the international legitimacy of a who-led process. the minimum core capacities set out by the ihr on their own are insufficient to respond to public health threats and emergencies, however, as highlighted by the commissions' recommendations in table . effective primary care and public health systems that underpin inclusive, high-quality universal health coverage (uhc) are also required to manage outbreaks and meet a broad range of health needs to ensure the right to health. fast-spreading novel infections are diverse, demanding resilient health systems. as outbreaks stretch existing resources, resilient systems that are designed to ensure surge capacity in health emergencies are needed. the un sustainable development goals (sdgs) expressly encompass infectious disease outbreaks and set a target for uhc by [ ] . many of the commissions' recommendations fall within the sdgs' framework as described in s table. the sdgs, in supporting universal health systems, stress health equity, which is also vital because outbreaks often emerge in marginalized communities and then rapidly spread. achieving resilient health systems is a shared national and global responsibility. by , every government should develop and publish concrete plans to achieve ihr core capacities by . by the end of the following decade, all nations should achieve the sdg target of health coverage for all. the commissions' reports reflecting on the ebola epidemic echoed a crucial point made by the ihr review committee on the response to the h n pandemic in its report-"the world is ill-prepared for a severe pandemic or for any similarly global, sustained and threatening public health emergency" [ ] . at an international level, the commissions' reports focused on reforms for who and the un system, but also discussed the role of the world bank and world trade organization (wto) ( table ) . if national health systems are the foundation for global health security, who is at the apex [ ] . yet who faces a crisis of confidence, with major critiques of its performance during ebola. the organization had previously cut nearly two-thirds of its emergency response unit; delayed fourand-a-half months before declaring a pheic; and lacked the governance needed to coordinate multiple stakeholders, including its regional and country offices [ ] . as featured in the recommendations in table , the commissions called for emergency preparedness and response to become "a core part of who's mandate, positioning itself as an operational organization" [ ] . the commissions also unanimously recommended that who create a centre for emergency preparedness and response (cepr), integrating and strengthening all its preparedness, response, no recommendation. who must develop an organizational culture for emergency preparedness and response. (rec. ) integrating regional & sub-regional networks who should strengthen its linkages with regional and sub-regional networks to enhance mutual support and trust, to promote sharing of information and laboratory resources, and facilitate joint outbreak investigations among neighboring countries. who should support the efforts of regional and sub-regional organizations to develop and strengthen their standing capacities to monitor, prevent, and respond to health crises. (rec. ) no recommendation. commissions' recommendations regarding who's ongoing reforms. as who's emergency operational capacities are upgraded, states must not cut funding for its other core activities, including noncommunicable diseases, injuries, and mental health-the harvard/lshtm panel recommended "its functions should be far more circumscribed" [ ] . in march , the secretariat launched who's health emergencies programme to assure "cross-organizational standards and rapid decision-making in health emergency operations" [ ] . the programme's development was influenced by the advisory group on reform of who's work in outbreaks and emergencies, whose recommendations are highlighted in table . whether the programme meets the panels' standards for a quasi-independent centre of high quality and accountability remains to be determined. currently, the programme has no sustained funding or independent governance. however, the director-general is establishing an independent oversight and advisory committee to monitor and oversee the programme's performance. when a health crisis escalates to a humanitarian disaster, even a well-resourced who will be unable to galvanize political will and coordinate a broader response, requiring operational control to shift to the united nations. table highlights the commissions' recommendations on the un's role and responsibilities during a health crisis. who should advise the un emergency relief coordinator to make this determination based on criteria for a level emergency (the highest level), including the epidemic's scale, economic toll, and political destabilization [ ] . the un inter-agency standing committee, "the primary mechanism for inter-agency coordination of humanitarian assistance," [ ] would establish procedures for un inter-agency coordination [ ] . a un security council resolution would elevate a crisis to the top tier of the global agenda. as binding international law, a council resolution would be more effective in mobilizing resources, sustaining political will, and securing state compliance with who recommendations. the secretary-general could also appoint a special envoy or establish a mission to implement security council directives [ ] . it is also important to ensure ongoing un engagement during inter-crisis periods. the un high-level panel recommended the general assembly form a council on global health crises, while the harvard/lshtm panel proposed a standing global health committee within the security council. creating a standing presence in a un organ and, where necessary, declaring a level emergency would raise the public and political profile of global health security in ways who has been unable to achieve. the ebola and zika epidemics revealed systemic deficiencies in r&d for diagnostic tests, vaccines, and therapies. the paucity of medical technologies stem primarily from low commercial priority, limited funding, and practical challenges of conducting human trials for episodic infections. yet medical countermeasures are vital to contain outbreaks and minimize their impact. as highlighted by the recommendations in table , who has a central role in establishing the normative framework for r&d including priority setting, accelerating trial design and administration, regulatory pathways, and equitable access. the organization spearheaded an international effort for an ebola vaccine. more recently, who identified eight pathogens as research priorities, but at a high level of generality [ ] . in march , who published more granular priorities for zika, including vector control [ ] . vaccine platform technologies may be able to accelerate the development of a vaccine for the zika virus, as well as other pathogens. yet, even with expedited vaccine development, inadequate access to existing vaccines still persists. for example, yellow fever vaccine stockpiles during a recent outbreak have been exhausted. cghrf recommended an independent pandemic product development committee to mobilize resources, coordinate public/private actors, and create a strategic r&d plan. cghrf, joined by other panels, urged $ billion incremental funding per year from combined governmental and private sources to jumpstart research innovations (table ). beyond implementing the commissions' bold agenda requires system-wide accountability. figs and demonstrate the commissions' suggested accountability frameworks during both inter-crisis and global health emergency periods. all frameworks would require continual communication and inter-agency collaboration, as well as partnerships with multiple stakeholders. the un high-level panel called for a summit on global public health crises in to assess implementation. the harvard/lshtm panel went further, proposing a un accountability commission to oversee the full range of actors [ ] . the commissions proposed greater who accountability, including independent oversight of a future cepr. to conform with who's constitution, accountability would reside in the executive board to which the new centre would report, with full transparency. the independent oversight and advisory committee of the newly established who health emergencies programme will report to the executive board, but ultimate authority rests with the director-general for who's work in health emergencies. holding sovereign governments accountable poses the greatest challenge. states have sometimes failed to promptly report potential pheics or share crucial health information. many states have erected unnecessary travel and trade restrictions or infringed on human rights. the commissions unanimously recommended that the director-general publicly name governments that fail to act as responsible global citizens [ ] . beyond transparency, it may be possible to coax states' compliance with their ihr obligations through skilled diplomacy and incentives. the commissions' proposals are ambitious, with action needed everywhere from civil society and research laboratories to geneva and national capitals. political attention to global health security can no longer be episodic, limited to when an epidemic strikes. political leadership must be sustained by standing agendas on health security at the wha, g , g , and security council, with the united nations overseeing crucial reforms. the commissions have defined a path forward. it would be a reckless disregard for human life and security to resist vital reforms. supporting information s report of the ebola interim assessment panel. geneva: world health organization ebola virus disease outbreak and follow-up to the special session of the executive board to ebola. geneva: world health organization will ebola change the game? ten essential reforms before the next pandemic. the report of the harvard-lshtm independent panel on the global response to ebola commission on a global health risk framework for the future, national academy of medicine, secretariat. the neglected dimension of global security: a framework to counter infectious disease crises secretary-general appoints high-level panel on global response to health crises level panel on the global response to health crises advisory group on reform of who's work in outbreaks and emergencies reform. geneva: world health organization ebola virus disease outbreak and issues raised: follow-up to the special session of the executive board on the ebola emergency (resolution ebss .r ) and the sixty-eighth world health assembly (decision wha ( )). eb / . geneva: world health organization geneva: world health organization report of the review committee on second extensions for establishing national public health capacities on ihr implementation: report by the director-general. geneva: world health organization monitoring and evaluation framework: joint external assessment tool: international health regulations fact sheet: the global health security agenda transforming our world: the agenda for sustainable development. a/res/ / . new york: united nations strengthening response to pandemics and other public-health emergencies: report of the review committee on the functioning of the international health regulations ( ) and on pandemic influenza (h n ) . geneva: world health organization a retrospective and prospective analysis of the west african ebola virus disease epidemic: robust national health systems at the foundation and an empowered who at the apex program budget - : wha . . geneva: world health organization inter-agency standing committee transformation agenda reference document, humanitarian system-wide activation: definitions and procedures inter-agency standing committee. welcome to the iasc who. who publishes list of top emerging diseases likely to cause major epidemics who. who and experts prioritize vaccines, diagnostics and innovative vector control tools for zika r&d how sars changed the world in less than six months the authors thank charles h. bjork, mary c. debartolo, eric a. friedman, chao quan, celynne balatbalt, and v. ayano ogawa for assistance with the manuscript and/or tables. wrote the first draft of the manuscript: log gml. contributed to the writing of the manuscript: log ot sw akj jf sm jp pp bs vjd gml. agree with the manuscript's results and conclusions: log ot sw akj jf sm jp pp bs vjd gml. all authors have read, and confirm that they meet, icmje criteria for authorship. key: cord- -cewpqddk authors: plotkin, bruce title: human rights and other provisions in the revised international health regulations ( ) date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: cewpqddk in may , the world health assembly of the world health organization (who) adopted the revised international health regulations ( ), which have now entered into force for who member states across the globe. these regulations contain a broad range of binding provisions to address the risks of international disease spread in international travel, trade and transportation. important elements include multiple provisions, whether denominated in terms of human rights or other terminology, that are protective of interests of individuals who may be subject to public health measures in this international context. with the vast (and increasing) numbers of persons undertaking international voyages and the global coverage of these revised regulations, they are an important development in this area. this article describes a number of these key provisions and some of the related issues they present. for several decades, the world health organization's (who) international health regulations ('ihr' or 'regulations'), formerly the who international sanitary regulations, were the primary global legal agreement against the international spread of infectious disease. while important, these prior regulations were quite limited in scope, dealing primarily with three to six infectious diseases, but none of the new, emerging or reemerging diseases (including those that had become drug resistant), or other critical longstanding diseases. by the s, the version of the regulations adopted in had also become outdated in terms of policy and technical approach. in the intervening decades, international travel and other traffic flows have increased sharply, and with them the opportunities for globalized disease spread. to address these concerns, the world health assembly in commenced the process of revising the regulations to update them in policy and technical aspects, and to broaden their scope to address the full range of internationally transmissible disease risks, whether currently known or as yet unknown. these newly revised ihr ( ) were adopted by the world health assembly on may and are now in force and legally binding for of who's member states; the last two member states are expected to become parties in august and in early . one of the important areas of innovation in the ihr ( ) involves their inclusion of explicit protections of the interests of individuals within the scope of this agreement, primarily with reference to international 'travellers' (defined in the regulations as a 'person undertaking an international voyage') in a range of circumstances. this subject was one of the key parts of the negotiations of the who member states resulting in the revised regulations negotiations. the importance of these protections for national delegations in the negotiations is underlined by the placement of human rights as the first 'principle' articulated in paragraph of article of the regulations, requiring that the 'implementation of these regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons'. the global agreement to the revised regulations reflects a broad consensus in a binding legal instrument, including agreement on the provisions that are the subject of this article. the broad scope of the ihr ( ) in terms of their global geographic coverage, the important subjects they cover, their coverage of an expansive array of diseases and public health events, and the escalating numbers of international travellers worldwide contributes to the potential overall impact of these new legal provisions. at the same time, the ihr ( ) are only now entering into force, and the practices under, and interpretations of, the new regulations by states parties, who and other international actors are in the process of being established. as with many complex, freshly negotiated international legal instruments, the precise meaning or import of some provisions, and how they may relate to other articles in the regulations or other relevant international instruments in particular circumstances, may not always be readily apparent. this article presents a summary description of some of the key provisions and some of the issues that they raise. diseases, public health risks and events the ihr ( ) completely revise the prior regulations, with extensive new mandates and obligations for the states parties and for who. article provides that their overall 'purpose and scope are to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade'. more specifically, the fundamental term 'disease' is defined as 'an illness or medical condition, irrespective of origin or source that presents or could present significant harm to humans'. as indicated in table , the definitions of other key terms, such as 'event' and 'public health risk', are similarly broad. in terms of notifying diseases and events to who, for example, states parties are obligated to notify any public health 'event that may constitute a public health emergency of international concern' based on specified criteria, as well as other international public health risks. with regard to travellers, the ihr ( ) also regulate key public health measures that states parties may implement against disease risks in international travel (persons), as well as in international transport (ships, aircraft, other conveyances) and trade (goods, cargo). under the regulations, protections for travellers were often stated in the context of limitations on health measures that countries could implement against the three 'quarantinable' diseases (cholera, plague and yellow fever) covered under the regulations since . for example, the prior regulations disease: 'an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans'; event: 'a manifestation of disease or an occurrence that creates a potential for disease'; and public health risk: 'a likelihood of an event that may affect adversely the health of human populations, with an emphasis on one which may spread internationally or may present a serious and direct danger'. prohibited vaccination against plague as a condition of entry to a state, as well as rectal swabbing in the context of cholera. under the revised ihr ( ), with the expanded coverage of disease, the scope of regulation of health measures applicable to international travellers is also broadened in light of the many covered diseases that may be spread by persons on an international voyage. some of the other, more prominent current diseases of concern include: polio; tuberculosis (particularly drugresistant tuberculosis); influenza; ebola and marburg viral haemorrhagic fevers; meningococcal disease; west nile fever; and severe acute respiratory syndrome. the breadth of coverage of the ihr ( ) and the vast numbers of travellers undertaking voyages that cross international borders every year guarantee that its provisions will be applicable to large numbers of individuals. in , according to the world tourism organization, there were more than million international tourist arrivals. overall, the numbers of travellers (international tourist arrivals) to each region were substantial: africa, . million; americas, . million; asia and pacific, . million; europe, . million; and the middle east, . million. the areas of greatest growth in international tourist arrivals were africa (+ %), asia and pacific (+ %), and the middle east (+ %). health measures applicable to travellers as noted, the ihr ( ) provide for a range of health measures potentially applicable to international travellers depending upon the particular circumstances and requirements. specific examples include: physical/medical examinations; health document requirements (including proof of vaccination or prophylaxis); certain types of itinerary and contact information; vaccination/prophylaxis; inspection of baggage; placing persons under public health observation; and the possibility of quarantine or isolation. additional provisions address when international travellers may be denied entry to a country on public health grounds. in the context of an event that has been determined by the director-general of who to be a public health emergency of international concern, article provides that the director-general will also issue specific temporary recommendations under the ihr ( ) of appropriate health measures to prevent or reduce spread of the disease and interference with international traffic. in article , the regulations contain a non-exclusive list of potentially relevant recommendations applicable to persons as appropriate to the circumstances (as well as others for baggage, cargo, containers and conveyances), from advice that no specific measures are appropriate, to advice that states require vaccination or prophylaxis, to recommending implementation of contact tracing or potential exit screening or other restrictions on persons from affected areas. for the purposes of this article, a number of these provisions can be divided into several categories (see table ). as noted above, the central principle on this issue mandates that the ihr ( ) are to be implemented 'with full respect for the dignity, human rights and fundamental freedoms of persons'. in contrast to most other related provisions, which refer to (international) 'travellers', this principle expressly refers to 'persons', a potentially broader category. although not as explicit on this issue, another principle mandates that implementation of the regulations is also to 'be guided by the charter of the united nations and the constitution of the world health organization', which can also provide guidance on evaluating application of ihr ( ) provisions to travellers, whether denominated as 'human rights' or otherwise. although generalized, these principles provide guidance on interpreting and applying the other, more specific articles to travellers. a number of provisions expressly provide for the prior informed consent of travellers (with certain exceptions) before being subject to medical examination, vaccination, prophylaxis or other health measures under the regulations. while the basic focus of each of these provisions is clear, the requirements are additionally to be 'in accordance with the law and international obligations of the state party'. as elsewhere in the ihr ( ) generally, this 'law' (presumably including applicable national law) and these 'international obligations' are not further specified. although not involving prior informed consent, the same article requires that medical examinations and procedures, as well as vaccination or other prophylaxis, be carried out in accordance with established national or international safety guidelines or standards. potentially, some of the most important of these protections are in article . in language similar to the principle on human rights and fundamental freedoms noted above, the article requires in general that states parties 'treat travellers with respect for their dignity, human rights and fundamental freedoms and minimize any discomfort or distress' associated with implementation of health measures under the regulations, including by taking into consideration their gender, sociocultural, ethnic and religious concerns. in more concrete terms, the article specifically requires that states parties minimize this discomfort or distress by 'providing or arranging for adequate food and water, appropriate accommodation and clothing, protection for baggagey, appropriate medical treatment, means of necessary communicationy and other appropriate assistance for travellers who are quarantined, isolated or subject to medical examinations or other procedures for public health purposes'. this provision may be particularly relevant in the context of a major outbreak or epidemic that involves quarantining or isolating substantial numbers of international travellers. from a financial perspective, additional important issues for international travellers concern whether they will be financially responsible for any health measures applied to them that are implemented for public health purposes. this was another intensely debated set of issues during the negotiations. in general, the ihr ( ) requirements distinguish between charges for vaccinations or prophylaxis provided on arrival (which are not generally prohibited from being charged to the traveller under the regulations unless the charges were not published at least days earlier) and certain other measures that may generally not be charged to the traveller, such as medical examinations under the regulations or supplemental examinations required to ascertain the traveller's health status, appropriate isolation or quarantine requirements, any certificates issued to a traveller documenting the measures applied, health measures applied to baggage, and vaccination or other prophylaxis requirements that were not published in advance as required. in addition, where such charges are permitted, each state party must have a single tariff for them, they may not exceed the actual cost of the service rendered, and the charge must not discriminate based upon nationality, domicile or residence of the traveller concerned. however, these restrictions on charges do not apply to travellers seeking temporary or permanent residence or to charges for health measures that are not implemented primarily for a public health purpose. in addition to these provisions, many others are also relevant in this context. a further set of issues concerns identification of those who are subject to these provisions in the regulations. as noted, under the ihr ( ), 'travellers' are, by definition, international (i.e. 'undertaking an international voyage'). most of the above provisions, but not all of them (the general 'principle' in article . refers to 'persons'), refer to treatment of 'travellers'. although it may not turn out to be an issue in 'real life', there may be questions about the status of particular individuals (see definition of 'international voyage' applicable to travellers). theoretically at least, a related set of issues may arise in events involving both (international) travellers, to whom the ihr ( ) would generally apply, as well as local nationals, perhaps those in or near a port or airport. separately, it should be noted that some of these provisions exclude travellers who are seeking temporary or permanent residence from the otherwise broader category of travellers covered under the regulations, as in article . (concerning health-related entry requirements for travellers) and article (concerning requirements for health documents in international travel). basic issues for resolution will also involve the underlying relationship within or between various relevant provisions in the regulations themselves. some have both types of exceptions; article (restrictions on health-based requirements for entry), for example, includes both specifically stated exceptions and a cross-reference to measures permitted under other articles. also, the breadth of some of these exceptions is not always clear. for scholars and other interested persons, it is also worth noting that the last three drafts of the proposed text of the revised regulations, prior to the final adopted text, are available on the who international health regulations website, with information on the evolution of these provisions in the course of the revision process and negotiations. [ ] [ ] [ ] designing an international policy and legal framework for the control of emerging infectious diseases: first steps world health organization. world health report : fighting disease, fostering development world health assembly. revision and updating of the international health regulations world health assembly. revision of the international health regulations tourism highlights edition: overview international tourism united nations economic and social council, un sub-commission on prevention and protection of minorities. siricusa principles on the limitation & derogation of provisions in the international covenant on civil and political rights world health organization. international health regulations: working paper for regional consultations review and approval of proposed amendments to the international health regulations: draft revision. geneva: who review and approval of proposed amendments to the international health regulations: proposal by the chair. geneva: who this paper was presented at the president session of the american public health association conference, boston, november .disclaimerthe author is a staff member of the world health organization. the author alone is responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the world health organization. key: cord- -q g vw y authors: o’neil, adrienne; russell, josephine d.; thompson, kelly; martinson, melissa l.; peters, sanne a.e. title: the impact of socioeconomic position (sep) on women's health over the lifetime date: - - journal: maturitas doi: . /j.maturitas. . . sha: doc_id: cord_uid: q g vw y the “social gradient of health” refers to the steep inverse associations between socioeconomic position (sep) and the risk of premature mortality and morbidity. in many societies, due to cultural and structural factors, women and girls have reduced access to the socioeconomic resources that ensure good health and wellbeing when compared with their male counterparts. thus, the objective of this paper is to review how sep - a construct at the heart of the social determinants of health (sdoh) theory - shapes the health and longevity of women and girls at all stages of the lifespan. using literature identified from pubmed, cochrane, cinahl and embase databases, we first describe the sdoh theory. we then use examples from each stage of the life course to demonstrate how sep can differentially shape girls’ and women’s health outcomes compared with boys’ and men’s, as well as between sub-groups of girls and women when other axes of inequalities are considered, including ethnicity, race and residential setting. we also explore the key consideration of whether conventional sep markers are appropriate for understanding the social determinants of women’s health. we conclude by making key recommendations in the context of clinical, research and policy development. in almost all countries, women live longer than men yet experience poorer mental health, greater disability and greater comorbidities. this paradoxical female advantage in life expectancy is, however, expected to decrease worldwide by [ ] . the excess mortality rates of men, especially those under age , have historically been explained by accidents and injuries. however, changing risk factor profiles observed globally, particularly from smoking cessation, have conferred greater survival gains in men. at the same time that these mortality risk factors have changed, the global economic climate has changed dramatically, particularly in recent times in the context of the covid- pandemic. austerity measures in response to economic downturns have and will continue to exacerbate socioeconomic inequalities for all. these widening socioeconomic inequalities may help explain the weakening female survival advantage [ ] . a social determinants of health (sdoh) framework seeks to understand how materialist and structuralist health inequities persist throughout life. this is a useful framework for understanding how the health and longevity of females differs relative to males and each other. a sdoh approach purports that health outcomes depend on the organisation and distribution of socioeconomic resources across any given society [ ] . the "social gradient of health" refers to the steep inverse associations observed between sep and mortality/morbidity [ ] . measures of sep (e.g., individual and household income, employment conditions) that are used to determined socially graded patterns are being thought of as inherently gendered. moreover, some have argued that the role of gender has subsequently been neglected in discussions of how sep influences health across the life course [ ] . this is despite the fact that, in almost all societies, women and girls, when compared with their male counterparts, have reduced access to the socioeconomic resources -namely education and/or employment -that ensure good health and wellbeing. this can stem from cultural biases and practices that can commence early in the life course (e.g., discriminatory feeding patterns, gender-based violence, uneven labour divisions) and persist across middle and later life (e.g., the gender pay gap, political impotence [ ] ). the ways in which sep is measured may affect interpretation of the social gradient of health for females. moreover, sep may exert its influence on the outcomes of women and girls differently to boys and men at specific stages of the life course. these concepts will, thus, be explored in this paper. the objective of this paper is to review how, what and when sep -a construct at the heart of the sdoh theory -shapes the health and longevity of women and girls. we first describe sdoh theory and then use examples from each life course stage to demonstrate how sep can differentially shape girls'/women's health outcomes compared to boys'/men's. these stages aligning with important sep transitions rather than those associated with biological development. we also consider differences in outcomes between sub-groups of girls/women when other axes of inequalities like ethnicity and residential setting are considered. we discuss how the timing and trajectory of sep across the life course may be important in these determinations and conclude by making key recommendations in the context of clinical, research and policy development. given the broad scope of our aims, it was not feasible to conduct a systematic review. rather, we conducted a narrative review based on targeted search of the research literature and author expertise. using keywords including "gender", "sex", "women", "girls", "social gradient", "socioeconomic status", "education", and "health", we searched pubmed, cochrane, cinahl and embase databases to identify articles published after the year . articles published within the last decade, systematic reviews, and primary studies with population-wide or crosscountry samples were preferentially included. we have focused on health conditions that are most pertinent to the lifespan stage in question, e.g., cognitive development in early life, overweight/obesity in adolescence, premature cardiovascular disease (cvd) in adulthood, and frailty in older age. where possible, we have included studies from non-western countries. throughout this review we have exclusively used the term "gender" in order to improve readability, but acknowledge that "gender" and "sex" are two separate but interrelated constructs with differential effects on sdoh [ ] . may underpin the association between low sep and poorer health outcomes. conventionally, "social class" and "socioeconomic status" (ses) have been employed as constructs for understanding how health outcomes are socially graded. while useful in illustrating the social gradient of specific health conditions, different indicators will produce varying slopes [ ] . "social class" as a socioeconomic measure has been argued to more accurately reflect "occupational class", while "ses" conflates different sep constituents like actual resources and status/prestige [ ] . sep instead exerts its influence on health via numerous exposures, resources, and vulnerabilities including income, poverty, and education. sep will be used henceforth. the sep-health relationship has been demonstrated repeatedly. a systematic review of studies [ ] found that people of lower sep have greater risk of mortality, cvd, cancer, amongst other health conditions, than those of higher sep. when data were disaggregated by gender, women of lower sep were especially vulnerable to coronary heart disease. however, it has been argued that, in the main, sdoh theory is often discussed without considering the inherent gender differences in sep and its measurement. this is in spite of the fact that women and girls are most disadvantaged by institutional policies and provisions that govern the labour market and family experiences that drive socioeconomic inequalities [ ] . with this in mind, we now consider how sep shapes morbidity and mortality of women and girls at critical life stages that align with important sep transitions. given the focus of women's health across the life course has often been centred around sexual and reproductive health, we have selected stages based on sep transition (e.g., educational attainment in adolescence and young adulthood), acknowledging that they may not occur in the same sequential manner for all women and girls and may vary across countries and settings. a sdoh framework is often guided by life course epidemiology; a field largely concerned with the timing of exposures, mechanisms, intermediary factors and resources that drive health inequalities across the life course [ ] . the enduring effects of early life exposures (economic, social, behavioural) from gestation to young adulthood on health outcomes in later life has been extensively examined. indeed, sep-graded health outcomes observed in adulthood have antecedents in early life [ , ] . however, the evidence shows gender differences are not always apparent in early childhood. for example, birth outcomes are shaped by parental socioeconomic factors and impact upon health across the life course. studies from industrialised countries have demonstrated that socioeconomic disadvantage at individual (e.g., parental ses), neighbourhood (e.g., poverty, unemployment) and national (e.g., gdp) levels increases the likelihood of adverse birth outcomes, including small-forgestational age, preterm birth, and low birth weight [ , ] . the way in which gender modifies the sep-health gradient appears dependent on the outcome of interest and the comparator group. for example, lower childhood sep is known to predict poorer physical and cognitive outcomes and acute medical conditions [ ] . for girls, the impact of poverty (as determined by parental income and mother's education) on cognitive developmental delays appears to be pronounced, especially when compared to boys [ ] . in australia, the most stark sep differences in -year old's development are within gender groups, with language and cognitive developmental delay more common for both male and female indigenous children than non-indigenous children [ ] . data from india suggest that although girls appear to be inoculated against the sep gradient in early childhood development, this is reversed after age , with boys (particularly those in the upper classes) performing better [ ] . indeed, lowmiddle income country status is highly correlated with indices that measure gender j o u r n a l p r e -p r o o f inequalities in reproductive health, political empowerment and economic status. thus country-level sep indicators including gender equality is an important predictor of survival. data from countries [ ] shows that the more gender unequal a society is, the lower the survival rate of girls compared to boys. again, using the example of india, girls under years with cardiac defects are less likely to have their guardians agree to cardiac surgery when compared to boys ( % vs. %). social class greatly influences access to treatment, with % of girls in the "upper class" receiving the surgery versus . % in the "upper-lower class". deep-seated social factors perpetuating gender biases, such as the customs of arranged marriages and "dowry", appeared to drive these poorer outcomes for girls [ ] . sep remains a powerful predictor of health in adolescence [ , ] , during which time parental employment, family affluence and composition are commonly constituents of an adolescent's sep. cognition outcomes continue to be socially patterned from childhood into adolescence [ ] and the same is true of physical health outcomes like weight. in the us, an inverse association exists between sep and overweight in adolescent girls (particularly white) but not boys [ ] . in other studies, sep and ethnicity interact to confer risk for physical health conditions like cvd and protective effects on mental health. data from the uk showed sep patterning for psychological well-being in girls [ ] , with low sep asserting a stronger influence on black compared to white girls. systolic blood pressure increased with level of disadvantage amongst black caribbean girls; a trend that was exacerbated in subsequent years [ ] . but cross-country comparisons reveal the complexity of the sep patterning of health of boys and girls, indicating it is largely context-specific. for example, in a national comparison of russian, us and chinese children/adolescents aged - , higher overweight/obesity was observed for: urban boys in china; urban girls from low-and highincome groups in russia; and african-american and mexican-american girls in the us (especially those aged ≥ years) [ ] . in zambia, one of the countries with the highest hiv burden in the world, young women have higher rates of hiv infection than young men. yet the gender gap is narrowing in both urban and rural areas [ ] attributed primarily to higher educational attainment of both sexes. an increasing proportion of young women enrol and stay in school, thus, delaying their sexual debut [ ] . in addition to preventing sexually transmitted infections, education can help prevent precocious pregnancy. a cross-national comparative study showed evidence of a strong, negative educational gradient in early childbearing in all high-income countries included. there was also an increase in the prevalence of early childbearing amongst lower educated females born between and in of the included countries, with only one country (poland) showing a decrease in the educational gap [ ] . paradoxically, gender bias can compromise educational attainment and result in early attrition from the education system. in some developing countries in which resources are scarce and girls may be required to earn money for their families, education deprivation is a significant issue affecting girls health and safety, especially in rural regions [ ] . the period from adolescence to young adulthood sees a transition from parental level sep affecting an individual's health to their own educational status shaping access to socioeconomic resource (e.g. higher income, stable employment) that protect against both the onset and consequences of ill health. higher levels of education attainment provide a basis for enhanced self-control and problem-solving skills in adulthood, that can facilitate both the adoption of lifestyle behaviours and entry into environmental contexts that promote health and wellbeing. data from the us show that women's self-rated health, which is typically poorer than men's, improved from - , and that this improvement could be largely accounted for by increased educational attainment across this same time period [ ] . in contrast, men did not experience a linear increase in self-rated health in this study, which suggests that women may reap greater health benefits from increased educational attainment. this is supported by evidence showing the deleterious health effects of having low educational attainment are more potent for women than men for cvd [ ] . this is even true in countries in which a greater number of women are graduating with university degrees than men [ ] . for many, this period of the lifespan sees individuals in gainful employment for the first time. studies utilising employment related markers like income as a measure of sep provide some insight into the health inequalities faced by women. in a cross-sectional survey of working-age catalonian residents, individual income showed a graded association with self-rated health for both men and women, whereby individuals with lower monthly incomes reported worse health. individual income accounted for women's poorer self-rated health compared to men's, with analyses adjusting for individual income abolishing this gender difference in health [ ] . occupational class has also been used to examine gender differences in sep and health outcomes. in a cross-sectional study of , barcelona residents, self-rated health was poorer for men in lower occupational classes, compared to that of managers and skilled supervisors. in contrast, only women in unskilled jobs had worse self-rated health than the reference category. rather, the number of hours per week of domestic labour was an important determinant of self-rated health in women, whereas it was not for men [ ] . the impact of children and family composition will be discussed in more detail in the following section. income and education continue to shape women's health into mid-life. with respect to the former, the whitehall study ii shows that men and women with the lowest individual income were significantly more likely to have metabolic syndrome, compared to those with the highest. although the magnitude of this effect was similar for both genders, the use of household income as a measure of sep revealed a relatively steeper social gradient of health for women than men [ ] . with respect to the latter, the gap in self-rated health between the lowest and highest educational levels appears to be widening in many western countries. this is somewhat dependent upon age, gender and race. in us citizens aged - , the education health gap remained relatively stable for men from - , whereas educational disparities in selfrated health diverged for white women and converged for black women [ ] . similar temporal trends have been found when examining mortality. in a study using us mortality data, middle aged ( - years old), white women experienced the greatest increase in the educational gradient of mortality, due to substantially increased mortality rates amongst those with high school diplomas or less [ ] . as discussed previously, educational attainment is a key indicator of age of first pregnancy which, along with family composition and relationship status, is of particular relevance both to women's ability to earn money and their individual health outcomes during this stage of the lifespan. during this period of adulthood whereby partnerships are formed and families are started, the role of household and partners' sep can begin to influence a woman's health. in general, marriage appears to be a protective factor for many health conditions [ ] . while married women have a survival advantage over unmarried women, the premium afforded to married men may be more pronounced [ ] . over recent decades, however, the marriage advantage appears to have increased. the assumption was that people with lower education were marrying less frequently while those of comparable levels of education tended to marry later. yet, us [ ] and norwegian [ ] data show that temporal changes in educational status of married people contributed little to the steepening health gradient. interestingly, data from hungary show that in middle-age, a married woman's sep has greater influence on her husband's mortality than his sep on her mortality [ ] . a population-wide norwegian study demonstrated that older men's mortality across all causes of death was strongly associated with their wife's educational status. meanwhile, a husband's income and occupation were related to few causespecific mortality outcomes in women [ ] . women with higher education levels tend to be more likely to engage in health-promoting behaviours [ ] . it is thus plausible they influence the diet, exercise, and smoking/drinking habits of their partners [ ] . while a recent metaanalysis of over million individuals found that being unmarried led to a greater risk of stroke and mortality for men compared to women [ ] , other meta-analyses have found no significant gender differences in the marriage advantage for cvd risk [ ] and mortality [ ] . changes in family composition owing to reproduction, child rearing and relationship breakdowns, are defining features of women's adult years. these factors have an important effect on professional attainment, employment conditions and career advancement and financial independence, and therefore how sep shapes women's health. while parity (i.e. motherhood) has been positively associated with better cvd risk [ ] ) across sep categories [ ] , other studies show that mothers have poorer self-reported health (in spite of similar rates of chronic conditions) particularly those living at or near the poverty line [ ] . part of the reason may be that motherhood is associated with financial penalties in the form of time out of the workforce (due to maternity and carers leave), but also potentially wage reductions [ ] . single mothers appear to be particularly disadvantaged in terms of sep and its impact on health outcomes [ ] . for example, despite greater opportunities for educational and employment attainment over recent generations, there are widening sep disparities for us women, especially for mothers without partners. since the s, the number of single-parent us households headed by women has tripled. ten percent of us women aged - years live in poverty, a plausible driver of increasing premature mortality rates. women aged - [ ] are the only sub-population in the us to have experienced large increases in coronary heart disease mortality since the early s. compared to same-age women in england, us women show earlier risk markers of chronic disease [ ] . differences for younger us women ( - years) are as pronounced as their older female counterparts for cvd risk factors such as obesity, cholesterol, heart attack, angina and stroke. us health inequalities clinically evident at early ages are best ascribed to socio-political influences rather than conventional risk factors [ ] . as women reach older age with greater disability and comorbidities, having accumulated less wealth due to relatively fewer employment-related opportunities, it stands to reason that older women are susceptible to the social gradient of health. there is evidence to suggest that indeed women's sep is more precarious over the life course for reasons discussed in previous sections (e.g., extended periods out of the workforce, reduced access to independent wealth) compared with men's which exhibits greater stability [ ] . data from the survey of health, ageing and retirement in europe (share) study (n= , ; + years of age) showed that while both childhood and current sep exerted strong and independent effects on self-rated health in older age, their relative influence differed by gender. for example, current sep explained less of the variance in self-rated health than childhood sep for men, whereas current sep was more important than childhood sep in explaining variance in self-rated health for women. in addition, all current sep indicators had a significant influence on self-rated health in older j o u r n a l p r e -p r o o f women, whereas being employed and household net wealth were not significantly associated with self-rated health in older men. thus, the authors concluded that sep in childhood was more predictive of older men's self-rated health, while current sep in older age was more important for women's self-rated health [ ] . conversely, poor health can also influence material wealth in later life. in new zealand, the odds for entering their s with material hardship were greater for women and māori, yet this association was attenuated by mid and late life adverse events such as onset of serious illness [ ] . interestingly, having children may provide protective health related effects. the sep of one's grown children has been shown predictive of risk of parental death, potentially independent of parent's own sep [ ] . of course, the gendered nature of sep-health trends in this age group are likely to be both outcome and country-specific. in south korea, a longitudinal study of aged + years found wealth was inversely associated with depressive symptoms (measured using the center for epidemiologic studies of depression scale) in men, whereas low education and income predicted depression in women [ ] . on the other hand, in england, data from the first two waves of the english longitudinal study of ageing (elsa) found no gender differences for wealth as a predictor of functional impairment (measured using six activities of daily living) in those above years of age [ ] . interventions and policies that mitigate deleterious effects of sep on girls' and women's health should target micro-, meso-, and macro-levels. whilst policies that provide universal health coverage is one obvious initiative, coordinated interventions targeting these levels are required to address gendered health inequities in underprivileged populations. in india, women of low sep have a lower share of hospital care than men, even when provided free access. this suggests that free hospital care alone is not sufficient to guarantee gender equity in healthcare access [ ] . it is well established that interventions reliant upon individual resources will preferentially advantage those of higher sep and thus maintain health inequalities [ ] . a key consideration is the socio-political environment in which individuals live, work and age, including the state-provided resources available. national social security provisions can insulate women's disease and mortality risk. this includes the extent to which a nation's welfare provisions allow for an acceptable standard of living independent from family relationships (defamilisation) and insulated from market dependence (decommodification). in countries with welfare systems that promote greater financial autonomy for women, a weaker social gradient of health for women would be expected. a longitudinal analysis of data comparing different welfare regimes within europe indeed support this hypothesis. the social gradient of health, as measured by the impact of education, income and wealth on -year change in frailty, was steepest for older women residing in southern european countries that are characterised by less defamilising and decommodifying welfare systems. conversely, this gradient was flattest for those living in northern european countries; typically characterised by comparatively high levels of gender equality and social democratic politics [ ] . whether these results are generalisable to other western nations or low-to-middle income countries is unclear. however, there is good evidence that the strength of association between women's sep and their life expectancy varies with level of economic development [ ] . conventional sep markers were developed by and for men and are generally not well-suited to assessing women's socioeconomic circumstances [ ] and associated health outcomes. here, we have provided examples showing specific measures may produce differential health gradients between women and men. if employment markers alone are used to assess women's engagement with the workforce and thus sep, disengagement with the workforce may be a marker of extreme wealth, child rearing, studying, disability or extreme poverty at different points of the life course. alternatively, using household income assumes women have equal access to pooled resources, which in many cultures is not the case [ ] . this might help explain why some studies using conventional measures show that sep-related health differences are more pronounced for men [ ] . studies where the mortality gradient was stronger for men than women have used employment [ ] and occupational exposures [ ] . yet classifying women's sep based on occupation is problematic given that women cannot always be classified appropriately using census data [ ] . thus, appropriate weighting and consideration of interactions between conventional markers of sep for women (e.g. education, marriage and number of children) may be required to acknowledge women's unique health circumstances. as such, there has been a push to broaden sep to include important inputs like social isolation, pessimism, childhood adversity, or domestic situation [ , ] . for example, the influence of childhood adversity [ ] and psychological strain/job satisfaction [ , ] is stronger for women than men. a study that investigated gender, mortality and sep by using both social disadvantage (defined by social distance from high sep [ ] ) and occupational class demonstrated that the social gradient of mortality was greater for women when using the former, and greater for men when using the latter [ ] . this suggests that the use of conventional, occupational based sep indicators may be underestimating the social gradient of health for women. ultimately the best sep marker by which to assess health inequalities between women/girls and men/boys and amongst women and girls requires consideration of life course epidemiology. this field seeks to understand the temporal trajectories, patterns and mechanisms by which sep drives health inequalities. applying a life course epidemiology framework that considers these assumptions is critical for determining research design and data collection as well as to guide resource allocation (examples of which are provided in the following section). to date, there is a lack of consensus regarding the exact trajectory of health inequalities over time; some argue the data show they widen, others purport they converge while others suggest they remain stable over time [ ] . while we have discussed the influence of sep in each life stage as discrete periods, they cannot be separated in our attempts to understand the relationship between sep, gender and health. this review highlights the complexities of these trajectories; they may be somewhat dependent upon stage of the lifespan, the health outcome of interest, setting and referent group. for example, an sep marker like educational attainment may not yield mortality benefits for women when compared to white men but may when compared to non-white women or when considering other inequality axes like age, race, disability or rurality. an added incentive for developing an approach that uses multiple and contextual sep indicators is that it may help to further disentangle the gender paradox of women's health. in clinical practice, medical practitioners require robust tools and clinical aids by which to assess and tailor patient care according to sep. there remains an absence of such tools much less those which consider the nuanced issues pertaining to gender or other axes of inequality discussed herewith [ ] . in the united kingdom and scotland, the qrisk [ ] and assign [ ] algorithms used in clinical practice to determine -year absolute cvd risk of j o u r n a l p r e -p r o o f patients include a measure of area-level material deprivation; one of the few such tools to do so. whether this measure of sep is most appropriate for utility in women of different ages, ethnic and other backgrounds remains unclear in the context of the issues discussed in this paper. this is largely because these tools have been developed and populated by data from male-dominated historical cohorts. nevertheless, the advantage of using and further developing and refining risk assessment tools that contain sep measures is not only critical for greater discrimination between cases and non-cases but for the purpose of equity. in the clinical context, the provision of lifestyle advice, counselling and interventions for preventing and managing chronic physical and mental conditions requires clinicians to appreciate that individuals living under conditions of scarcity cannot freely make decisions about their own health and investments that may, in fact, afford them the opportunity to escape those very circumstances [ ] . where low sep is identified, an understanding of how limited economic resources restrict decision making can help guide the implementation of health promoting incentives -especially for those on welfare who have high material deprivation. from a public health perspective, investment in early life education of all, and especially girls in settings of marked gender inequality, is critical to lifelong health. in conjunction with other interventions, education (both formal attainment and health literacy) appears to be the key to improving sep and is a strong determinant of future employment and income [ ] . . skills and knowledge obtained from greater education may enhance confidence, adeptness or receptiveness to health education [ ] . however, the greatest reduction to the social gradient of health can arguably be achieved by developing interventions that minimise the extent to which socioeconomic resources confer a health benefit [ ] . this notion has underpinned many public health initiatives, which have aimed to overcome differences in sep. one pertinent example is the fortification of flour with folic acid in over countries worldwide. this is opposed to recommending that women take folic acid supplements during pregnancy, which disadvantages women of lower sep due to issues of cost and access. preliminary evidence suggests that folic acid fortification of flour at a population-level reduces the risk of neural tube defects in foetuses and improves the folate status of women of reproductive age [ ] . acknowledging the heterogeneity both between women and men and amongst women in the context of analytic frameworks is critical. pragmatically, research in this area should consider interactions between gender and both conventional and non-conventional sep markers to ensure that health inequalities for sub-populations are not concealed. consensus on genderspecific sep indicators across the life course are required. of note, there has been work developing tools by which to assess adolescents' material circumstances and family affluence as a measure of self-reported family socioeconomic status [ ] . further research is necessary to develop indicators specific to developing countries, given that the majority of this research has been generated in developed countries. the role of sep on the health and longevity of women and girls is complex and fluctuates throughout the life course. this trajectory appears dependent upon (i) the outcome of interest and setting in which the research is conducted; (ii) how sep is defined and the level (macro or micro) at which it is measured; and (iii) the extent to which other axes of inequality are considered (ethnicity, residential setting, indigenous status). how sep is measured and applied is an important consideration given that many women are likely to have variable engagement with the workforce and possible financial reliance on others at various stages of the life course. it is likely that the conventional concept of sep itself may inherently misrepresent genderbased inequalities in health. taking a broader view of sep, that includes psychosocial inputs and considers sep as a web of interconnected variables, may 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s.g.o.r. estimation, adding social deprivation and family history to cardiovascular risk assessment: the assign score from the scottish heart health extended cohort (shhec) a behavioral-economics view of poverty education and occupational social class: which is the more important indicator of mortality risk? whad'ya know? another view on cultural literacy social conditions as fundamental causes of health inequalities: theory, evidence, and policy implications fortification of wheat and maize flour with folic acid for population health outcomes assessing socioeconomic status in adolescents: the validity of a home affluence scale key: cord- -wvsc qv authors: davalbhakta, s.; sharma, s.; gupta, s.; agarwal, v.; pandey, g.; misra, d. p.; naik, b. n.; goel, a.; gupta, l. title: private health sector in india: ready and willing, yet underutilized in the covid- pandemic. date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: wvsc qv background: the private medical sector is a resource that must be estimated for efficient inclusion into public healthcare during pandemics. methods: a survey was conducted among private healthcare workers to ascertain their views on the potential resources that can be accessed from the private sector and methods to do the same. results: there were respondents, % of them being doctors. nearly half ( . %) felt that the contribution from the private medical sector has been suboptimal. areas suggested for improved contributions by the private sector related to patient care ( . %) and provision of equipment ( . %), with fewer expectations ( . %) on the research front. another area of deemed support was maintaining continuity of care for non-covid patients using virtual consultation services ( . %), tele-consultation being the preferred option ( %). . % felt that the government had not involved the private sector adequately; and . % felt they should be part of policy-making. conclusion: a streamlined pathway to facilitate the private sector to join hands with the public sector for a national cause is the need of the hour. through our study, we have identified gaps in the current contribution by the private sector and identified areas in which they could contribute, by their own admission. the novel coronavirus disease (covid- ) has consumed and exhausted widespread national health resources with unprecedented speed, and is expected to leave lasting consequences on global health, economy and growth. the massive losses call for the amalgamation of rapid innovations alongside bold public health measures led by a courageous political will to tackle this unique "war sans weapon" situation. as of may th , india has reported , covid- cases, a number that is rapidly rising, consuming the public healthcare system, which has been at the fore of this pandemic, despite deficient infrastructure, manpower and poor resources. , amongst other countries, india currently ranks fourth with regards to daily increase in the cases. with an availability of . public-hospital beds to population , it is not unreasonable to expect that the public sector may not be able to provide effective, sustained and uninterrupted healthcare in the face of the rising numbers. not surprisingly, countries ahead of us on the pandemic curve have recognized the need to utilize all available healthcare resources, forging partnerships between public and private healthcare sectors. in india, the healthcare scenario has transformed over the last few decades, , and almost % services are provided in the private sector, making it a major stakeholder. the first decade of this century saw a growth in private sector beds by almost %, bringing their total share to nearly %. although healthcare professionals in private enterprises are best suited to provide insights into potential areas of access from the private sector and methods to do so, yet there voices are seldom heard in the scientific world. improvements in outcomes and health indicators have been reported after private-public partnerships (ppp) in previous reports. the national health policy (nhp) not only advocates for exploring role of ppp in achieving universal health coverage (uhc), but ppp has also been proposed as an efficient model for disaster risk reduction. , the present survey was conducted to explore the opinions and preparedness of healthcare workers (hcws) in the private sector, on public-private partnerships (ppp) to provide a sustained, uninterrupted healthcare response in the face of the current pandemic. an online survey was conducted in april , and a pre-tested, content validated questionnaire was circulated over whatsapp® groups of healthcare professionals (doctors, nurses, technicians, students and administrators amounting to nearly individuals) in the private hospitals across india. the participants were requested to provide an informed consent at the beginning of the survey. we did not offer incentives for participation. the questionnaire featured questions, of which five identified respondent characteristics. fourteen items were multiple choice, with one being open-ended. the average time to complete the survey was five minutes. the respondents could change the answers before submission but not after it. internet protocol addresses were checked to avoid duplication of responses. content validity of the survey questionnaire was performed using lawshe's method and confirmed by three professors and one undergraduate medical student. the validated survey questionnaire was pre-tested among five hcws, and the identified errors in wording, grammar or syntax were rectified. the 'logics' feature available on survey monkey® allowed respondents to skip to a specific question on a later page based on their answer to a previous close-ended question. descriptive statistics were performed, and the results were expressed as numbers (percentages). the data/figures were downloaded from surveymonkey.com®. ethics approval exemption from review was obtained from the institute ethics committee [ - -ip-exp] as per local guidelines. we adhered to the checklist for reporting results of internet e-surveys to report the data. the participants included doctors ( % of the respondents) (age years + . ), and nurses or medical students ( %). nearly half ( . %) felt that the contribution from the private medical sector has been suboptimal. suggestions for improved contributions included patient care ( . %) and provision of equipment ( . %), and research ( . %). (figure ) participants suggested increased involvement in screening ( . %), testing ( . %), intensive care ( . %) and non-intensive-care ( . %) beds. some ( . %) felt that effective home outreach services could also be provided. participants believed that the private healthcare sector could provide insights into new testing methods ( . %), vaccines ( . %) and new or repurposed drugs ( . %). most participants ( . %) preferred use of their financial contribution for subsidized treatment of patients while only % favored donation to public agencies. most respondents felt that they could play a significant role in educating healthcare workers, medical students, and the community. another area of deemed support was maintaining continuity all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint of care for non-covid- patients, using virtual consultation services ( . %), teleconsultation being the preferred option ( %). more than half ( . %) felt a need for greater involvement of the private sector in the pandemic response including policy making. nearly half of the participants had made monetary donations for the pandemic from their personal funds ( . %). teleconsultations were being offered by doctors. more than a third ( . %) felt that they wanted to contribute more towards the pandemic response, and as many as % were keen to donate blood. in our e-survey assessing the opinions and readiness of hcws in the private healthcare sector, we found that participants felt that they had not contributed enough and were positively inclined to participate in the pandemic response. they expressed readiness to participate in screening, testing, patient care, support for equipment and clinical trials of newer drugs as well as repurposed medicines, vaccines or newer diagnostic tests. while testing and tracing contacts remains the primary public health response to an infectious disease pandemic, over million samples have been tested in india since january . although we have attained testing capacity of lac samples per day, it would still take more than three and a half years to test % of the population. this appears to be an optimistically conservative but inadequate strategy in a country with more than . billion susceptible individuals. , collaborations between government and private healthcare centers can decentralize screening and testing facilities, offloading central agencies while increasing the capacity and outreach. while the public sector has been holding forte in the past few months, the need for additional resources is being increasingly felt. the private healthcare sector has significant potential, [ ] [ ] [ ] with % of the hospitals, % of the beds and % of doctors. under severe strain, similar collaborations have been forged in italy, spain and several other countries. a similar exercise in india would be a prudent way ahead in these times. a large number of blood banks are in the private healthcare sector in india, and it might be worthwhile to explore the conversion of private blood banks into specialized units for the promising convalescent plasma donation therapy, if efficacy is proven in ongoing clinical trials. this will not only tide over the ongoing acute shortage of blood products but also be a sustainable source of convalescent plasma for therapy in severe covid- . in fact, a vast majority of respondents expressed their willingness to donate blood to tide over the acute shortage of blood products in present times. while most public facilities are busy in covid- care, patient with non-covid ailments have faced neglect and apathy. private healthcare respondents are willing and prepared to participate. additionally, a forward triage protocol using tele-medicine services may in-fact hearald a revolution for a large number of technology-enabled non-covid patients. in the western world too, teleconsultations are being increasingly preferred as means of avoiding congestion in public spaces. although lower literacy levels and traditional patterns of doctor-patient interactions are a challenge in providing effective home-based outreach care in india, yet the scope of mobile networks and empowerment by these hand-held computers cannot be underestimated. nearly two-thirds of the respondents felt that the private sector could leverage its financial resources by providing free or subsidized treatment to patients. while the government makes efforts to meet the requirement of ventilators, stuttering from the onslaught of paused supply from europe and china, it is prudent to recognize and utilize the dormant resources lying in the private hospital intensive care. [ ] [ ] [ ] further, private laboratories and research facilities, encouraged to develop new cost-effective and rapid high through-put testing methods, should start showing results soon. in unusual times such as this, lessons could be learnt from past experiences. during the influenza pandemic of , all dealings in india were restricted to the public sector to keep track of cases all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint while ensuring affordable healthcare. this eventually led to an infrastructural deficit, and the consequent need to amend policies to include support from the private sector. such experiences from previous epidemics have probably contributed to our hcws believing that the private sector in india can participate in a more significant manner. this is the first survey including a wide set of stakeholders in the private healthcare sector and in our opinion, it is an important move in the right direction to ascertain willingness and preparedness. the results, subject to opinionated biases of a small set of young technology-empowered respondents, largely doctors are nevertheless enlightening and encouraging. further, since this survey was electronically distributed, it has the advantage of a diverse representation of voices across the country, and yet opinions may be influenced by differential approach determined by local state policy. in the face of an unprecedented disease, with mystical transmissibility and unprecedented ability to devastate the human population, it is not surprising that the public healthcare sector is under more stress than it can handle alone. we have a large private healthcare sector in our country which is not only equipped but also willing, to share the burden of disease. thus, a pragmatic approach to facilitate the private-public partnership will go a long way in mitigating the community impact and reduce mortality in current times. an open, healthy and swift discussion between the public and private sector should be the first step towards sorting grey areas. table : : survey respondent's suggestions on how private practitioners can contribute on a professional front. all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . other (please specify) ( . %) all rights reserved. no reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . (which was not certified by peer review) is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted june , . . https://doi.org/ . / . . . doi: medrxiv preprint the socio-economic implications of the coronavirus pandemic (covid- ): a review covid- to trigger roughly million job losses: ilo. accessed the three steps needed to end the covid- pandemic: bold public health leadership, rapid innovations, and courageous political will the challenges confronting public hospitals in india, their origins, and possible solutions in the dark even after a decade! a -year analysis of india's national rural health mission: is family medicine the answer to the shortage of specialist doctor in india? india now ranks fourth globally on daily increase in covid- cases. the wire covid- | is india's health infrastructure equipped to handle an epidemic? accessed capacity building of private sector workforce for public health services in india: scope and challenges the private health sector in india private sector contributions and their effect on physician emigration in the developing world the indian health care system | health care | public health. international healthcare system profiles india -lessons for universal health coverage. dangal g, ed. plos one ministry of health and family welfare, government of india. national health policy public and private partnership in disaster risk management public-private partnerships (ppp) in disaster management in developing countries: a conceptual framework perception about social media use by rheumatology journals: survey among the attendees of iracon improving the quality of web surveys: the checklist for reporting results of internet e-surveys (cherries) coronavirus update (live): , , cases and , deaths from covid- virus pandemic -worldometer. accessed population, total -india | data we need strong public health care to contain the global corona pandemic india turns to private sector to boost health coverage. devex what can be done about the private health sector in low-income countries? how technology is changing health care in india the italian health system and the covid- challenge spain nationalises all private hospitals, uk rents hospital beds current and future applications of telemedicine to optimize the delivery of care in chronic liver disease census of india: literacy and level of education health needs, access to healthcare, and perceptions of ageing in an urbanizing community in india: a qualitative study local ventilators need of the hour to prepare for covid- . livemint lockdown . : over migrant workers reach lucknow from nashik by special train -the economic times video | et now covid- risks and response in south asia existing health inequalities in india: informing preparedness planning for an influenza pandemic key: cord- -zfctgm p authors: leventhal, alex; ramlawi, assad; belbiesi, adel; sheikh, sami; haddadin, akhtam; husseini, sari; abdeen, ziad; cohen, dani title: enhanced surveillance for detection and management of infectious diseases: regional collaboration in the middle east date: - - journal: emerg health threats j doi: . /ehtj.v i . sha: doc_id: cord_uid: zfctgm p formed before international negotiations of the revised international health regulations (ihr), the middle east consortium for infectious disease surveillance (mecids) is a regional collaboration aimed at facilitating implementation of the revised ihr and, more broadly, improving the detection and control of infectious disease outbreaks among neighboring countries in an area of continuous dispute. initially focused on enhancing foodborne disease surveillance, mecids has expanded the scope of its work to also include avian and pandemic influenza and other emerging and re-emerging infectious diseases. here, we describe the history and governance of mecids, highlighting key achievements over the consortium's seven-year history, and discuss the future of mecids. since the last decade of the previous century, there has been a continuous trend of increasing globalization of commerce, travel, production, and services. while this new phenomenon is providing many countries with significant economic advantages, it is also increasing the risk of novel infectious disease threats. other environmental, host, and agent-related factors have contributed to the emergence or re-emergence of various infectious diseases ( , ) . the broad geographical dispersal of these newly emerging pathogens in both products and people has raised the need for new surveillance and response capabilities. the ability to sensitively, specifically, and promptly identify particular strains or subtypes of organisms using modern diagnostic techniques has become essential for rapidly and efficiently responding to disease outbreaks and preventing potential epidemic or pandemic spread. additionally, as recent outbreaks of severe acute respiratory syndrome (sars) and avian and pandemic influenza have demonstrated, these new threats are changing the way that outbreaks are dealt with*from mainly local and national responses to regional and even global approaches ( Á ). global collaboration in infectious disease surveillance is orchestrated by the world health organization (who), most recently through the revised international health regulations (ihr ) ( ) . a legally binding document signed by all who member states, the revised ihr set rules for improving communication between who and member states and mandate that each country has the laboratory capacity to rapidly identify outbreaks. a year before the international negotiation of the revised ihr, a sub-regional surveillance network, the middle east consortium for infectious disease surveillance (mecids), was established as a means to facilitate implementation of the ihr in three neighboring countries: jordan, israel, and the palestinian authority (pa). since then, mecids has enjoyed a close relationship with the who, not just with respect to the revised ihr (see text box ), but also with respect to receiving ( ), it has a special relationship with the world health organization (who) in general and concerning the ihr in particular. this is true even of the pa, who is not a member party in the ihr agreement (i.e., because the pa is a member of mecids, palestinian officials participate in all mecid activities). in addition to the who generously providing public health advisors for mecids projects. mecids principals were chief delegates of their countries for international negotiations around the revised ihr; and mecids was operating according to the principles of the revised ihr even before the ihr were implemented. for example, during the ai outbreaks in (see case study no. ), mecids partners decided to act according to the revised ihr even though the regulations were not being enforced yet ( ) . in , mecids partners participated in a special workshop on how to implement the ihr in the mecids region. who officials from the ihr headquarters in geneva and from the eastern mediterranean and european region offices attended the meeting. most recently in june, , senior who officials attended a mecids workshop where officials from all three mecids country ministries of health drafted a trilateral public health agreement for regional land border crossing. the following month, mecids shared their ihr experience at a who ihr seminar in lyon, france. the potential for a middle eastern partnership in infectious disease surveillance was discussed in november, , at a meeting held by two washington, d.c.-based non-governmental organizations, search for common ground (sfcg) and the nuclear threat initiative (nti). meeting participants included public health officials and academics from jordan (ministry of health and royal scientific society), israel (ministry of health, tel aviv university), and the palestinian authority (pa) (ministry of health, al-quds university). the vision was of a partnership that facilitates cross-border cooperation in public health, particularly in response to infectious disease outbreaks, through capacity building and also by encouraging human relationships that enhance regional stability and security. the initial focus of mecids was on the sharing of data on foodborne disease outbreaks, specifically salmonella. the same approach was more recently implemented for shigella, another foodborne and person-to-person transmitted enteropathogens. since then, data sharing has expanded to other disease areas, including avian and pandemic influenza and, most recently, vector-borne diseases. although its work began earlier (e.g., as described in text box . training regional training is an ongoing mecids activity. initially, trainings were aimed at improving salmonella diagnostic capabilities. in september, , palestinian, jordanian, and israeli health professionals participated in a five-day workshop in istanbul on key epidemiology concepts and other relevant knowledge that would help the professionals to monitor and respond to regional disease outbreaks. the following spring, microbiologists from all three countries attended a salmonella identification workshop in israel, where they received hands-on training from specialists at the jerusalem central laboratory of the israeli ministry of health. the four-day curriculum covered a range of topics, including salmonella serotyping and phage typing, pulsed field gel electrophoresis (pfge), use of the vitek machine that mecids purchased for all three countries, and antibiotic resistance testing. in april, , an additional training course on interventional epidemiology was held in israel; professionals from israel and the palestinian authority attended. recently, efforts have shifted away from salmonella, toward other issues. laboratory and public health professionals from all three countries have attended meetings dedicated to the identification and alex leventhal et al. characterization of another foodborne pathogen, shigella; general laboratory safety and security issues; and the use of bioinformatics in microbiology and molecular epidemiology. mecids has been effective on many levels. in addition to sharing data and analyses, mecids partners have harmonized their infectious disease diagnostic and reporting methodologies; conducted joint trainings; and facilitated cross-border communication between laboratory technicians. additionally, the partners established protocols for collaborative cross-border investigation of infectious disease outbreaks; set up an automatic notification system for cross-border events; and tested their preparedness for pandemic influenza. here, we highlight three case studies that reflect the progress mecids has made during the last seven years. the consortium's first major undertaking was to establish a regional laboratory-based foodborne disease surveillance network ( figure ). mecids partners agreed that significant upgrading in foodborne disease surveillance methods would play an important role in preventing and controlling the emerging foodborne disease outbreaks, which public health experts were predicting would increase as food trade in the region increased. also, of note, as part of the who strategy to reduce the global burden of foodborne diseases, jordan had been selected as the first sentinel site in the who eastern mediterranean region for a series of studies on the burden of salmonella, shigella, and brucella diseases. the studies revealed that foodborne disease burden was being underestimated and called for establishment and enhancement of sentinel laboratory-based surveillance for both salmonella and shigella in particular ( Á ). because of the likelihood that mecids would expand to other countries in the middle east in the future and so that the network could be integrated with other existing networks in europe (e.g., enter-ne, salm-gene) and the united states (e.g., foodnet, pulsenet), the partners decided to build a network that was comparable to those existing networks ( , ) . specifically, mecids chose salmonella as its first foodborne pathogen target. the partners sought to establish a network of sentinel microbiological laboratories with the capabilities to identify salmonella; harmonize data collection methodologies and built a common platform for communication, data sharing, and analysis; and strengthen reference laboratory capabilities to characterize salmonella phenotypes (i.e., serotypes) and genotypic markers. in view of differences in existing capabilities and infrastructures between countries, the partners agreed that each country would outline its own specific immediate objectives which, once met, would help to achieve the overall goal of a regional foodborne diseases surveillance network ( ) . each country selected which microbiological labs would serve as sentinel labs in the network; and designated a national reference lab (nrl). in addition to selecting which laboratories would participate in the network, partners also developed standard testing procedures. the surveillance population was defined as patients attending sentinel labs for stool and/or blood cultures, food-handlers attending sentinel labs for stool cultures, and food items received by food labs. specimens are tested for the presence of salmonella using the same standard operating procedures; organisms identified as salmonella in sentinel labs are submitted to the nrl for serogrouping, serotyping, and antimicrobial susceptibility tests. also at the nrl, pulsed field gel electrophoresis (pfge) is performed on selected isolates using standard protocols developed by the salm-gene network in europe. as a rule, salmonella isolates are preserved at ( c for further testing and genotyping. additionally, each country established a data analysis unit to manage all of the surveillance data and to serve as a central national focal point. data collection started in (i.e., two years before mecids was formally established). data include patient information (sex, age, if they are inpatient or outpatient subjects, address, etc.), as well as specimen type (stool, blood or urine) and isolate (salmonella serogroup and serotype). in each country, data collected from both the sentinel labs and nrl are recorded in specifically designed data collection forms and sent on regular basis to the designated national data analysis units (i.e., the disease control directorate in jordan, disease control in the palestinian authority, and the center for diseases control in israel). when an outbreak is first detected, the national data analysis units play a major role in alerting the public health authorities and initiating epidemiological investigations ( ) . the mecids consortium also identified a regional data analysis unit: the middle east scientific institute for security (mesis), located in amman, jordan; and established a mechanism for the national systems to share their data with the regional unit. country reports that have been prepared by the national data analysis units, excluding patients' personal identifiers, are sent routinely to the regional unit where data are stored and regularly posted on the mecids website; national data are secured and only mecids members and authorized users are able to access them. also, interim regional reports are presented and discussed at mecids executive board meetings; and posted on the consortium website. a manuscript compiling analyzed data of the first six years of regional salmonella surveillance is in preparation. establishment of a middle east regional laboratorybased foodborne disease surveillance network was a process Á one that required building human and technical capacity so that partners could work together at similar levels of capability. this capacity was built largely through collaborative training. text box describes a series of joint training courses on interventional epidemiology and laboratory technology that addressed not just salmonella diagnostic capabilities, but also shigella surveillance and regional infectious disease surveillance in general. in some cases, the necessary capacity building also involved the supply of equipment. for example, mecids developed support for the supply of pfge equipment to jordan and palestinian authority (both for the west bank and gaza), enabling both partners to collaborate with israel which already possessed the equipment. mecids researchers have also been involved in a variety of research projects on infectious disease burden in the middle east. in , mecids researchers reported on the underestimation of childhood diarrheal disease burden in israel ( ) . more recently, mecids scientists completed a still unpublished study on the source and mode of transmission of salmonella infantis in israel, where the proportion of salmonella isolates identified as s. infantis dramatically increased after . interestingly, recent serotyping of a large collection of salmonella isolates from jordan, palestinian authority and israel showed high similarity in the distribution of salmonella serotypes in israel and the palestinian authority and differences in comparison to that of the jordanian serotypes. these findings are most probably related to the closed links in food trade between israel and palestinian authority. mecids partners share a unique geographical situation. located at the junction of three continents (asia, africa and europe), between the mediterranean sea and arabian desert, the three countries act as a ''bottleneck'' through which a large portion of the world populations of certain migratory bird species concentrate on their way to and from their winter quarters in africa ( figure ). these birds serve as a continuous source of viruses, such as west nile and avian influenza (ai). it has been estimated that every year approximately million birds pass through israel alone. thus, when the h n ai pandemic threatened the middle east, with poultry outbreaks occurring in nearby turkey (october ), the ministries of health and agriculture of the three mecids countries agreed to hold a meeting to discuss the threat. the meeting, which was held in istanbul, turkey, in december, , was attended by senior officials from the ministries of health and agriculture of jordan, israel, and the pa, as well as senior officials from the egyptian ministry of health, who, u.s. centers for disease control (cdc), and the european union. each country presented its national ai and pandemic influenza preparedness plan (the ministries of health of the attending countries had been drafting national preparedness plans since or before), and the foundation was set for real-time exchange of information in the event of an ai outbreak in the region. two months later, on february , , another coordination meeting on ai took place on the king hussein bridge, a land crossing between israel and jordan, in order to share information on recent developments in ai preparedness. on the following day, the first ai outbreak in egypt was detected involving backyard poultry, wild bird, and human cases. although this outbreak took place hundreds of miles from the mecids countries, the threat was clearly imminent. indeed, on march , , the first case of ai in any mecids country was diagnosed in israel in some industrial coop turkey populations near the border with the pa gaza strip. the diagnosis was confirmed by the israeli central veterinary laboratory. four suspected human cases were referred to hospital emergency rooms, but none turned out positive for ai. this event was communicated immediately by phone to points of contact at the palestinian and jordanian ministries of health that had been designated at the istanbul meetings. the world organisation for animal health (oie) and who were also immediately notified. over the course of the next two weeks (march Á , ) , a total of nine outbreaks of ai were recorded in industrial poultry coops across israel. five of these outbreaks were in coops bordering the gaza strip, of which one was in proximity to the egyptian border; one outbreak took place in a poultry coop near jerusalem, in proximity to the west bank; and one outbreak took place in a settlement in the northern jordan valley near the border between israel and jordan. all poultry within three kilometer protective zones around each of the nine outbreak foci (i.e., a total of . million birds in israel) were culled by poisoning their drinking water. in addition to the ai outbreaks in israel, samples from sick poultry in gaza that were sent by the pa veterinary services to the israeli central veterinary lab on march , also tested positive for h n . in response, on that day, a meeting took place at the gaza crossing, with both israeli and palestinian veterinary and health officials attending. the officials agreed on shared protocols for coping with the outbreak and arranged for personal protective equipment, oseltamivir tablets, and poison for poultry culling to be transferred from israel to the pa. over the course of the next two weeks, h n virus was diagnosed in four additional locations along the gaza strip, among both industrial coop and backyard poultry populations. authorities culled , birds using the same method that had been employed in israel. jordanian authorities culled , birds in the three kilometer protective zone. on march , , a tri-country coordination meeting took place in jerusalem. the meeting was also attended by the who officer to the pa and a member of the egyptian embassy in israel. meeting attendees shared information regarding the regional ai threat and discussed cooperation, coordination and assistance among the health and agriculture ministries. today, looking back six years after the event, mecids partners believe that the cooperation, mutual reporting and assistance that occurred at the time and which are described here significantly thwarted the ai threat. the opportunity to compare and synchronize preparedness plans prior to the event (i.e., during the istanbul meeting in december, ) contributed to the successful mitigation and communication efforts that occurred during the actual ai outbreaks. the cooperation that occurred during the ai outbreaks extended beyond the neighboring countries providing each other with tangible aid (e.g. supplying the equipment necessary for bird culling). but also, public health officials in all three countries were updated in real-time. in addition, communication with the media was harmonized and contradictory messages to the public were prevented. the experience built trust and confidence among mecids member countries in crossborder health crisis management Á a confidence that was tested and proven when the h n pandemic influenza threatened the region. case study : regional response to the h n influenza pandemic ( ) following the ai crisis, in and mecids conducted a series of national pandemic influenza tabletop exercises to identify gaps in preparedness and crosssectoral cooperation and to develop a plan of priority actions to improve preparedness and response. also in , the partners conducted a regional tabletop exercise to test cross-border cooperation and procedures in the event of a pandemic. the regional exercise involved not just public health experts and ministry of health officials, but also representatives from the transportation, education, interior, laboratory, and media sectors. the exercise was conducted in cooperation with observers from who (from headquarters in geneva and both the eastern mediterranean and european regional offices) and the turkish ministry of health. the following year, a novel influenza virus, h n , began its global spread. on april , , just two days after who raised the h n pandemic threat level to phase , mecids partners held an emergency teleconference to discuss a joint plan of action to mitigate the spread of h n into and out of the middle east. at that time, there were a few suspected cases in israel. two days later, on april , in response to h n influenza outbreaks throughout the world, who director-general dr. margaret chan raised the influenza pandemic alert from phase to phase . on may , mecids partners met at the who office in east jerusalem with observers from the who and the egyptian embassy. the partners agreed to implement and coordinate prompt border and airport screening, laboratory testing, information exchange, and common communication strategies. this coordination was made possible by the confidence in cross-border health crisis management and trust among mecids partners that had been building over the past several years and to well-exercised national and regional pandemic preparedness plans. the need for such coordination was made all the more critical by the coinciding detection of new cases of avian influenza h n in egypt and concerns that the two influenza viruses would combine and form a new pandemic influenza virus. in mid-june, the who raised the influenza pandemic alert from phase to phase . at about the same time, jordan and the pa reported their first cases of h n , mostly among university students returning from summer vacations in canada and the united states. not until july , when who acknowledged that further spread of the pandemic was inevitable and that individual case counting was no longer essential, did the three mecids countries stop sharing daily reports of new cases. the various national and regional networks of collaboration, communication, and information exchange that mecids partners have established over the past seven years are helping the partners not only estimate disease burden ( ) but also harmonize public health intervention and prevention strategies ( , ) . the laboratory surveillance systems established or strengthened by mecids are an important component of this regional effort. however, a key challenge facing mecids is the significant lag time that still exists between the different stages of surveillance data collection and reporting (i.e., sentinel lab diagnosis, reference lab characterization of isolates, reporting). this time lag prevents real-time use of data. another challenge is the need to be cognizant of variation in cultural and scientific sensitivities and representativeness that exists among the three mecids partner countries when making data comparisons at the regional level. the ''bottom-up'' evolution of mecids through interactions between public health officials on opposite sides of country borders has been an important driver of mecids's success. the consortium was not built through a ''top-down'' directive from member countries or from agencies outside the sub-region. indeed, mecids has become a good example for other infectious disease networks that have emerged over the years and, through connecting organizations for regional disease surveillance (cords), is sharing its experience with others. at the same time, cords also enriches mecids with other networks' experiences and good practices, especially with respect to implementing a ''one health'' approach in tangible and rewarding ways and more than in the ad-hoc manner employed in response to the avian influenza outbreaks in mecids countries (case study ). mecids focus on foodborne diseases remains strong, with mecids partners not only responding to outbreak situations but also developing shared methods and a common regional database and researching the contribution of specific foods and foodborne pathogens to total disease burden. with more precise food-and pathogenspecific estimates, mecids partners will be able to construct effective food safety policies aimed at improving food trade and exchange in the region while simultaneously reducing the burden of foodborne disease. in the future, the consortium plans to extend its laboratorybased surveillance network from salmonella and shigella to other enteric pathogens, such as enterotoxigenic escherichia coli, campylobacter jejuni, and selected protozoa and viruses of public health importance in the middle east. global trends in emerging infectious diseases regional infectious disease surveillance networks and their potential to facilitate the implementation of the international health regulations from the field side of the binoculars: a different view on global public health surveillance. health policy plan public health surveillance and infectious disease surveillance revision of the international health regulations. resolution no. wha . who consultation to develop a strategy to estimate the global burden of foodborne diseases methods for foodborne disease surveillance in selected sites burden of self-reported acute diarrheal illness in foodnet surveillance areas activities, achievements, and lessons learned during the first years of the foodborne diseases active surveillance network: Á recent trends in the epidemiology of non-typhoid salmonella and antimicrobial resistance: the israeli experience and worldwide review a middle east subregional laboratoryÁbased surveillance network on foodborne diseases established by jordan, israel and the palestinian authority assessment of the underestimation of childhood diarrhoeal disease burden in israel regional collaboration in the middle east to deal with h n avian flu trust across borders: responding to h n influenza in the middle east email: alex.leventhal@moh.health.gov.il mecids citation: emerg health threats j to mecids donors that have trusted us and have bestowed upon us their contributions: search for common ground (sfcg), the nuclear threat initiative (nti), the world bank, becton, dickinson and company (bd) and the international council for the life sciences (icls); who headquarters and the european and east mediterranean region that have supported us; the respected ministries of health that have encouraged our work; and for every worker in the public health services and in the academic institutions that by their industrious work have contributed to the health of our nations. key: cord- - hifagu authors: wernly, bernhard; wernly, sarah; magnano, anthony; paul, elizabeth title: cardiovascular health care and health literacy among immigrants in europe: a review of challenges and opportunities during the covid- pandemic date: - - journal: z gesundh wiss doi: . /s - - -w sha: doc_id: cord_uid: hifagu objectives: europe is a destination for many migrants, a group whose proportion of the overall population will increase over the next decades. the cardiovascular (cv) risk distribution and outcomes, as well as health literacy, are likely to differ from the host population. challenges related to migrant health status, cardiovascular risk distribution and health literacy are compounded by the ongoing coronavirus disease (covid- ) crisis. methods: we performed a narrative review of available evidence on migrant cv and health literacy in europe. results: health literacy is lower in migrants but can be improved through targeted interventions. in some subgroups of migrants, rates of cardiovascular disease (cvd) risk factors, most importantly hypertension and diabetes, are higher. on the other hand, there is strong evidence for a so-called healthy migrant effect, describing lower rates of cv risk distribution and mortality in a different subset of migrants. during the covid- pandemic, cv risk factors, as well as health literacy, are key elements in optimally managing public health responses in the ongoing pandemic. conclusions: migrants are both an opportunity and a challenge for public health in europe. research aimed at better understanding the healthy migrant effect is necessary. implementing the beneficial behaviors of migrants could improve outcomes in the whole population. specific interventions to screen for risk factors, manage chronic disease and increase health literacy could improve health care for migrants. this pandemic is a challenge for the whole population, but active inclusion of immigrants in established health care systems could help improve the long-term health outcomes of migrants in europe. non-communicable diseases (ncds) are the primary cause (around %) of death worldwide. among ncds, cardiovascular disease (cvd) is the top cause of death, being responsible for about % of mortality (cosentino et al. ; knuuti et al. ) . the management and outcomes of ncds have improved over the past few decades. the scientific community contributed to a better understanding and new pharmacologic and interventional treatment options (cosentino et al. ; knuuti et al. ). however, from both an individual level and public health perspective, disease prevention is preferable to managing established chronic disease. health literacy is fundamental to successful prevention (magnani et al. ) . large-scale immigration of non-european refugees peaked in in europe but is likely to continue in upcoming years. immigrants differ from the host population with regard to genetics, baseline risk distribution, lifestyle and health literacy (cainzos-achirica et al. ). these differences affect the prevalence and incidence of ncds. also, access to health care is challenging for immigrants in some countries. the united nations defines a long-term migrant as a "person who moves to a country other than that of his or her usual residence for a period of at least a year." europe was a source of migration in the nineteenth century, but is now a destination for migrants. between and , the number of migrants living in europe increased from million to million and is expected to continue to rise (rechel et al. ). these million migrants suffer from high rates of unemployment and low socioeconomic status and are, therefore, not only a humanitarian but also an economic and public health challenge (rechel et al. ) . health care data on migrants in europe is scarce for several reasons, including nonstandardized definitions of migrants in health care systems and limited resources for public health research (rafnsson and bhopal ) . however, the description of challenges and opportunities migrants pose for public health might be crucial for improving health care for all. in december , the new coronavirus severe acute respiratory syndrome coronavirus (sars-cov- ) emerged, causing coronavirus disease (covid- ). clinically, covid- manifests similarly to influenza (symptoms such as fever, cough dyspnea, myalgia), but appears to have a higher risk of mortality than influenza, particularly in the elderly (huang et al. ) . the world health organization (who) declared the ongoing crisis a pandemic. as a consequence, policymakers reacted to covid- with extensive public health measures, most notably non-pharmacologic intervention and physical distancing, which have been shown effective in prior pandemics (markel et al. ). there is increasing evidence supporting the concept that patients with pre-existing cv conditions are at higher risk of death due to covid- (huang et al. ) . although covid- primarily manifests as a respiratory disease, patients with covid- die from inflammatory, cv and respiratory causes (huang et al. ) . both the disease itself and the social, public and economic consequences of the covid- pandemic are likely to affect the lives of migrants throughout europe. the integration of migrants in the european public and health care systems is likely to be affected by covid- . furthermore, the successful management of the sars-cov- pandemic using nonpharmaceutical interventions depends on the compliance and participation of migrants. we, therefore, aimed to summarize the evidence on cvd and health literacy of immigrants in europe. further, we evaluated the relation between the ongoing covid- pandemic and migrant cv risk distribution and health literacy. we performed a narrative review of cv risk distribution and health literacy in migrants in the european union, including switzerland, norway and the united kingdom. migrants, immigrants and refugees included people from all developing countries as well as eastern european countries and the balkan region, which are not part of the european union. this group was analyzed in light of the challenges related to the ongoing covid- pandemic. we performed a search on medline and google scholar using the keywords "migrant," "refugee," "cardiovascular," "diabetes," "hypertension," "non-communicable disease," "sars-cov- ," "covid- " and "covid" in different combinations. in total, the search yielded manuscripts. after deletion of duplicates and reports not concerning countries of the european union, as well as manuscripts considered to be outdated based on our subjective clinical/public health expertise, references were screened in depth. also, reviews and statements on the topics of health literacy and migrant health were screened for relevant literature. further, we screened co-citations using the cocites algorithm for other relevant manuscripts. based on available evidence and our judgment, the final manuscripts were included in this narrative review. cvd is highly prevalent and leads to high mortality, morbidity and costs in both developing and developed societies (benjamin et al. ) . however, the rates of cvd also differ within western and non-western countries, as the distribution of risk factors and preventive measures of local health care systems vary rechel et al. ). moreover, the economic capabilities of health care systems to provide cvd management according to the latest guidelines differ and likely contribute to differential outcomes worldwide (cosentino et al. ; knuuti et al. ) . the european host societies are more often urban and evidence higher levels of environmental pollution (sohail et al. ) . the host societies also promote behavioral changes among refugees, such as a sedentary lifestyle, which consequently changes the cv risk profile of migrants (sohail et al. ) . depending upon the host country and the degree of integration, access to health care and the living conditions of migrants can influence outcomes in either first-generation or later-generation migrants or in none of the migrants (raymundo et al. ) . migrant populations are difficult to characterize, since their situations vary greatly. in one review, the rates of ischemic heart disease and stroke were heterogeneous among migrants in europe (sohail et al. ) . migrants from the middle east and south asia exhibited similar or higher rates of cvd and stroke compared to the host population (sohail et al. ) , in contrast to migrants from northern africa, who may have a lower rate of stroke. in another study from the netherlands, south american migrants had higher stroke rates, while north african migrants demonstrated lower risk for cvd (bos et al. ). this finding of lower risk for cvd in north african migrants was confirmed by a spanish study, which reported lower rates in north african populations as compared to higher rates in asian and sub-saharan african groups (regidor et al. ). of note, the living conditions in the host countries are an additional contributing factor for differential rates of cvd, as south asian migrants were at an even higher cvd risk than their relatives in the country of origin (bhatnagar et al. ) . in the rodam [research on obesity & diabetes among african migrants] study, sub-saharan african migrants in europe showed higher rates of cvd than their counterparts living in a rural environment . while some of the effects might also be attributable to rural versus urban environments, the differences between migrants and their peers in an urban home country setting were small ). finally, the cvd outcomes and mortality of migrants differ between european host countries (bhopal et al. ; sohail et al. ) . interactions between the country of origin, host country and rural versus urban environment all play a role in determining cvd risk . in sub-saharan african migrants, hypertension is consistently more prevalent than in host populations commodore-mensah et al. ; modesti et al. ). in the netherlands, the rates of hypertension in male migrants of sub-saharan african origin was above %, compared to % in dutch males (agyemang et al. ) . studies across europe have confirmed the finding of a higher prevalence of hypertension in immigrants . also, the disease was less successfully managed in migrants compared to the host population, which could indicate worse access to health care but also compliance problems (agyemang et al. ; agyemang et al. ) . in addition to hypertension, rates of type diabetes are higher in migrants . diabetes is a key risk factor for cvd, and its management is difficult and usually long-term in nature (pernow et al. ) . strikingly, diabetes is more prevalent among virtually all ethnic migrant groups sohail et al. ) . a meta-analysis by meeks et al. recently confirmed this finding and found higher rates of diabetes among asian, middle eastern and african migrants compared to european host populations . mainly migrants from south asia suffer from very high rates ( - times) of diabetes compared to european host populations . moreover, the onset of diabetes is not only more common but occurs more than years earlier in immigrants (snijder et al. ) . migrants are more likely to suffer from both microand macrovascular complications related to diabetes (vandenheede et al. ) . in one study, diabetes mortality was almost twice as high in migrants as in european host patients (vandenheede et al. ) . both the living conditions in the host countries and genetic factors may explain this finding (galbete et al. ) . the rates of obesity are higher in migrants as well ). also, differential patterns in diets, physical exercise and socioeconomic "dysstress" likely contribute to the higher burden of diabetes in immigrants (cosentino et al. ). however, these factors might not be enough to explain the differences in prevalence and outcome, and a deeper understanding of both access to health care but also genetic and epigenetic factors is crucial for fully evaluating the observed differences. given the complex and interdisciplinary management of diabetes, this finding underscores the potential impact on european health care systems (cosentino et al. ) . this conundrum reflects the multifactorial pathogenesis of cvd, which is the common final pathway of arterial hypertension, obesity, diabetes, socioeconomic factors and behavioral factors-such as physical exercise and nutrition-as well as genetic factors (cosentino et al. ; knuuti et al. ) . these are all likely to either differ between migrants and the host population or be influenced by the migration and the subsequent changes in living conditions, income, access to health care and environmental factors. migrant health is not a unidimensional subject. there is also evidence for the so-called healthy migrant effect, describing lower rates of cv risk distribution and mortality in migrants as compared to the host population (delgado-angulo et al. ; gkiouleka and huijts ). in a danish study including more than , migrants and , age-and sex-matched danes, the mortality rates were consistently lower in immigrants (norredam et al. ) . a swedish register study supports this finding of lower cv events in migrants (helgesson et al. ). byberg et al. observed a similar pattern in a large register evaluating cvd incidence and mortality in , migrants matched : to persons born in denmark: migrants had lower rates of death, and the subgroup of family-reunified migrants had lower rates of cvd (byberg et al. ) . some studies have reported that the observed differences in cvd risk between migrants and the host population decline in a time-dependent manner (harding et al. ). in the netherlands, north african migrants lost the advantage of lower cvd over time as the gap closed (van oeffelen et al. ). these findings of increasing cvd rates in migrants over time is supported by intergenerational studies (sundquist and li ; van oeffelen et al. ) . in sweden, second-generation migrants tended to exhibit higher rates of cvd than first-generation migrants, and the risk almost converged to the rates of the host population (sundquist and li ) . health literacy is an essential cornerstone of health promotion (kickbusch ). nutbeam proposed three levels of health literacy (nutbeam ) . first, functional health literacy relates to basic knowledge, including literacy, arithmetic, an understanding of disease and health services. second, interactive health literacy corresponds to the social skills necessary for communication with health care providers. third, critical health literacy refers to a broader knowledge of health-relevant information and the ability for informed decision-making (nutbeam ) . the health literacy of migrants could be impaired-but also improved through tailored interventions-on all of these levels (fernandez-gutierrez et al. ) . of note, a systematic review found interventions to be effective in increasing health literacy in immigrants (fernandez-gutierrez et al. ). however, specific programs targeting health literacy in migrants are scarce and not well studied, and there is likely both opportunity and demand for improvement (jones et al. ) . health literacy is key to successfully preventing and managing ncds (magnani et al. ) . interestingly, some studies indicate high awareness of ncd risk factors among migrants . the rates of treatment were higher in some groups of migrants compared to the respective host population . still, there are substantial data indicating suboptimal management and control of cvd risk factors in migrants . therefore, language barriers, differential perception of risk factors and concepts of health and disease are likely to contribute to a lack of adequate health care in migrants (nutbeam ) . health care providers need to recognize these differences on an individual basis. from a broader perspective, policymakers need to consider addressing and reaching out to migrants in innovative ways (jervelund ) . for example, in the united states, blood pressure measurement in barbershops, a popular social gathering place among american black men, was shown to improve control of arterial hypertension in this population (rader et al. ) . patients screened for diabetes in barbershops evidenced higher rates of impaired glucose tolerance compared to the general population (osorio et al. ). the ongoing covid- crisis will affect humans across the globe as the epidemiology of this virus continues to unfold. however, it becomes increasingly clear that cvd constitutes a significant risk factor for severe illness (zheng et al. ) . the specific pathways of this association are the subject of ongoing research. still, protecting the vulnerable will be a key strategy in controlling covid- (verity et al. ). therefore, identification of patients at high risk for severe lifethreatening covid- is necessary. migrants evidence higher rates of cvd, particularly hypertension and diabetes, which have been linked to adverse outcomes in covid- . therefore, the protection of these individuals is important. however, extending such protection relies on educating these patients about the new disease. patients need to understand the risks of infection, how to limit exposure and who is at risk. as a result of the described limitations in health literacy but also language barriers, protecting migrants at risk will be challenging (spiegel et al. ) . specifically, approaches in different languages need to be tailored to enable the public health systems to reach out to these patients (greenaway et al. ) . migrants are more likely to live in areas with greater population density, both in migrant camps and in european urban areas (costa and de valk ) . the basic public health measures, including physical distancing, hand hygiene, and quarantine of symptomatic individuals and contact persons, are difficult to implement under these conditions (maroko et al. ) . therefore, the distribution of migrants from camps to other, less densely populated areas with access to adequate housing and hygiene is now not only a philanthropic, but also a public health demand . these measures, mitigating the spread of the sars-cov- , will improve the health not only of migrants but of all inhabitants (brandenberger et al. ) . as long as migrant camps persist, disease-specific management should be available: testing, tracking and tracing of both migrants inside and workers from outside have to be in place to avoid the introduction and transmission of sars-cov- (brandenberger et al. ). information about the virus and non-pharmacologic intervention measures should be available in the migrants' native language, partly as an important countermeasure against fake news spreading via social media (islam et al. ) . increasing the health literacy in newly arrived migrants could increase the acceptance of non-pharmacologic intervention, help to detect and isolate infected individuals and protect the vulnerable (christie and ratzan ). migrants are over-represented in the european homeless population (anh ly et al. ) . for homeless persons, hygiene measures, self-isolation if symptomatic and social distancing may be nearly impossible (bhopal ; tsai and wilson ) . oftentimes, homeless migrants sleep in crowded institutions during the winter. in this setting, transmission is likely and mitigation complicated (bhopal ; tsai and wilson ) . limitations of this review include its narrative design. further, the terminology for immigrants is not precise and the population is highly diverse-in demographics, home country and host country. thus, analysis as a single group based on their commonality as immigrants is an inherent oversimplification. moreover, the distribution of source and host countries evolves over time within the growing european union. therefore, the literature selection was based on both structured review of available evidence and our subjective judgment of the suitability of the manuscripts reviewed here. migrants and the european host population differ regarding cvd risk distribution and outcomes. both biological (genetic, epigenetic) and non-biological (socioeconomic, behavioral) factors contribute to the observed differences. cv migrant health and risk factors are a multidimensional matter. some immigrants do have higher rates of some cvd, most importantly hypertension and diabetes. lower rates of health literacy and signals towards worse control of chronic diseases in migrants could lead to significantly worse outcomes in this population. however, in other migrant subgroups, cv outcomes are even better than the host population. this "healthy migrant effect" is likely multifactorial but could include genetic reasons, the age-distribution, a selection bias ("migration of the fittest") and lifestyle factors. this effect was predominantly described in the first generation of migrants, and there is evidence suggesting that the healthy migrant effect diminishes over time. the european population should try understanding and integrating the reasons behind better health in some migrants. implementing these measures in the whole community could benefit public health. migrants are both an opportunity and a challenge for european public health. young and healthy migrants will likely contribute workforce, gross domestic product and wealth necessary to provide resources for the public health. tailored programs to increase health literacy, screen for risk factors and manage chronically ill migrants such as the american barbershop interventions could improve outcomes. while the european host population does have a strong tradition of gathering in barbershops, other similar environments popular with immigrants could be a stage for basic health care and health literacy interventions. during the pandemic, the european union may benefit from granting migrants universal access to the local health care systems. excluding migrants from health care likely decreases testing and tracing in this population group, which could counteract local containment, mitigation and suppression strategies. another concern during the covid- pandemic is that patients with chronic illnesses may not seek care due to social distancing measures and restrictions in access to care. a delicate balance exists between ensuring social distancing to minimize sars-cov- infections and promoting necessary contact between patients and health care providers. the application of e-health and telemedicine might be limited in migrants because of socioeconomic factors, language barriers and health literacy (hollander and carr ) . thus, emerging methods of physically distanced care for the host population may be much more difficult in migrants. once a vaccination is available for sars-cov- , health literacy might be key to promoting vaccination among immigrants, although the role of health literacy and vaccination hesitancy and acceptance is a subject of concern (lorini et al. ). the higher rates of risk factors and the lower rates of health literacy are a significant concern for migrants. the younger age of migrants, especially those who arrived recently, could constitute an advantage for the aging european populations. younger patients have lower rates of severe illness due to covid- and may contribute to herd immunity, which may ultimately be necessary to protect the vulnerable. during the pandemic, the universal inclusion of migrants in health care systems could help to ensure testing, tracking and tracing in the whole population. european societies need to provide both care and information to immigrants. this pandemic is a challenge for the whole population, but the necessary active inclusion of immigrants in the health care systems could also help with the long-term integration of migrants in europe. funding open access funding provided by paracelsus medical university. ethics statement not applicable for a narrative review. the authors whose names are listed above certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers' bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements) or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript. open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes 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to jurisdictional claims in published maps and institutional affiliations key: cord- -msjtncek authors: sharifian, neika; sol, ketlyne; zahodne, laura b.; antonucci, toni c. title: social relationships and adaptation in later life date: - - journal: reference module in neuroscience and biobehavioral psychology doi: . /b - - - - . - sha: doc_id: cord_uid: msjtncek social relations encompass a complex and dynamic set of characteristics that have been shown to distinctly affect health and quality of life across the lifespan and especially in older adulthood. in this chapter we begin with a brief review of several prominent theories of social relations. next, we consider how social relations can be understood based on the resource they provide (e.g., contact frequency, social support), the relationship they stem from (e.g., friends, family), the strength of the tie (e.g., strong, weak) as well as the means of communication (e.g., offline, online). we briefly summarize how these characteristics have been shown to uniquely influence health and quality of life in older adulthood. finally, we contemplate potential clinical applications, provide recommendations for the future and offer final concluding comments. social relations have been increasingly recognized as fundamentally important to the health and well-being of individuals in every part of the world and may be especially relevant in later life. older adults may be more susceptible to the risks of social isolation due to age-related changes such as retirement, changes in health, and loss of network members (e.g., widowhood). indeed, survey research conducted in the united states reports that american adults aged years and older report spending over half their waking hours alone (livingston, ) . about %, estimated to be roughly . million individuals, of all non-institutionalized american older adults reported living alone in (administration for community living & administration on aging, ). although higher proportions of older adults living alone are seen in north american and nordic countries (reher and requena, ) , similar trends are emerging globally. for instance, in singapore, the number of older singaporeans ( years and older) living alone is estimated to increase by % from ( , ) to ( , ) (ministry of health, ). further, the proportion of older adults world-wide is also increasing (i.e., population aging). as of , an estimated . % of the world's population was aged and older. by , this is projected to increase to %, and by , . % of the world's population will be years or older (he et al., ) . this increase in the older adult population is paired with the proportion of youth (under years old) remaining flat over the same time period (he et al., ) . a rapidly aging population will face several socioeconomic and health-related changes such as increased chronic disease burden, increased healthcare costs, and reduced labor supply (bloom et al., ) , this despite the fact that people are remaining healthier longer. as social relations are a modifiable factor that has been linked to a variety of health-related outcomes (cacioppo and cacioppo, ; cornwell and waite, ; coyle and dugan, ; steptoe et al., ) , coupled with increases in population aging, the need to understand the implications of social relations or lack thereof (i.e., social isolation) is becoming more relevant and more urgent. in past decades, the field has made great progress in developing increasingly sophisticated evidence to document the who, what, why, and how of social relations. as the field moved forward, social relations was identified as an umbrella term that refers to structural characteristics of the social network (e.g., age, gender, education of network members), social support (e.g., aid, affect or affirmation that is exchanged) and support adequacy or satisfaction (e.g., the evaluation of the support network and social support available to the individual). all of these aspects of social relations, in turn, affect the individual's health and well-being both contemporaneously and longitudinally. while empirical evidence has accumulated in support of positive effects of social relations on health and well-being, there has also been recognition that not all social relations are positive or have a positive effect on people. it is clear that some people are disadvantaged by negative or ambivalent relations which, in turn, have the potential to negatively influence health and well-being. this greater specificity has framed and advanced the scientific study of social relations. in this chapter we begin with a consideration of several prominent theories of social relations, highlighting important characteristics of social relations as well as potential age-related changes in social relations. next, we move to a summary of extant knowledge about how social relations are associated with health and quality of life by examining the hierarchical breakdown of social relations (see fig. ). to exemplify this, we can use contact frequency, one specific dimension of social relations, as an example. contact frequency is one unique social resource stemming from social relations and can be viewed as distinct from other social resources (i.e., social support, social strain, etc.). this resource can further be broken down by examining the source of this social contact. is the individual interacting with friends, family, children, their spouse, a neighbor, etc.? even further, an examination of the strength of that specific relationship tie can also highlight the unique contributions to health. is the individual interacting with a close or more casual friend? or a combination of close family and casual friends? finally, as technology is increasingly facilitating social interactions, we examine how individuals are in contact with their social ties. is the individual interacting with a close friend inperson or simply calling a friend to chat? each of these dimensions may have unique implications for how social relations influence health and quality of life. in this chapter, in line with this breakdown of the complexities of social relations depicted in fig. , we discuss the different dimensions of social relations, including positive and negative aspects of relations. further, we will consider different relationship types from parents and peers in early life to family and friends in later life, noting the critical role of each. we also examine the interesting and evolving research recognizing the strength of weak ties. finally, with recognition of the rapidly changing world and influence of technology, the means of communication are reviewed and discussed. individuals engage in social relationships across the life course and it is important to note that age-related changes in the structure, function and quality of social relations occur in later life. prior theoretical and empirical evidence has documented the structure of older adults' social networks as well as mechanisms that may explain shifts in social relations such as partner selection and how older adults deal with interpersonal conflict. the following section highlights three prominent theories commonly used in the aging literature that focus on social relations: ( ) the convoy model of social relations, ( ) socioemotional selectivity theory, and ( ) the strength and vulnerability integration model. we acknowledge that these are not the only theories regarding aging and social relations. our discussion here is simply meant to be illustrative of prominent theories often cited in prior literature. the convoy model of social relations (antonucci, ; kahn and antonucci, ) was designed to include the individual as part of a dynamic network across the lifespan and over the life course. this model is less culture laden and allows the individual to project their own convoy as they experience it without being driven by external norms or expectations. under optimal conditions, the convoy surrounds and supports individuals throughout their life-time. personal characteristics, such as age, gender, and personality, as well as situational characteristics, such as role expectations, resources, and demands, shape the individual's current and evolving convoy. ideally, the people who form an individual's convoy provide a reassuring foundation that helps an individual grow, develop and cope with their life experiences. at the same time, situational factors provide the context within which these social relations evolve. context is important because it situates the individual's expectations as well as the demand characteristics of organizations, roles, and/or norms. both are critical in the development of social relations. in , antonucci & akiyama published one of the first empirical examinations of the convoy model using data from a national study of adults years of age and older collected in . they documented the structure and function of respondents' convoys and examined separately the influence of spouse, children, family and friends. in , antonucci, ajrouch and webster replicated that study with data collected in from a regionally representative sample and showed remarkable similarities in structure. both cohorts had convoys of similar size, gender composition, years known and sources of support, suggesting that these characteristics are fairly consistent over time. network size in both samples included approximately people, included more women than men, and individuals knew their network members, on average, years. there have also been changes in convoys over the years and not always in the direction that might have been predicted. more recent cohorts were older, lived closer to and had more frequent contact with their network members than the earlier cohort. on the other hand, there was one notable difference in network composition. proportion of family that composed a convoy was significantly smaller in . reports of emotional closeness were largely the same in the two cohorts, assessed as the number of people defined as closest ( - ), closer ( - ) and close ( - ). composition of convoys were also fairly similar. convoys consisted, in both samples, of spouse, children, siblings and other family and friends. only the percentage of family decreased over the two samples. all others were substantially the same. the authors conclude not only that these are critical characteristics of a convoy but also that despite many demographic and social changes, these appear to be basic and critical elements of the convoy. empirical studies of the effect of social relations on health using the convoy model permit a detailed examination of these associations, often resulting in more nuanced findings or greater specificity with respect to long held or traditional findings. we provide three such examples with respect to mortality, socioeconomic status and network member education. a classic and very important finding in the literature indicates that people with more positive social relations live longer. this is a finding we do not mean to contest. however, antonucci and colleagues found that under conditions of serious or life-threatening illness, people with more negative relations live longer. they interpret the finding as indicating that under some situations negative relations may be experienced as negative but prolong life by encouraging life-saving behavior change such as diet, exercise or adherence to a medical regimen. another classic finding is that people of lower socioeconomic status have poorer health than people of higher socioeconomic status. this, too, is generally true. yet, in another study by antonucci and colleagues (antonucci et al., ) , middle aged men of lower socioeconomic status with key support from their children were as healthy as men of higher socioeconomic status. and finally, webster and colleagues (webster et al., ) found that the education level of network members was significantly associated with an individual's self-rated health, above and beyond their own educational attainment and also controlling for that individual's age, gender, race, and marital status. while it is a long standing finding that higher education is associated with health, this finding indicates the importance of the education level of the people closest to you for your own health. in summary, these findings suggest that careful assessment of personal, situational and social relations characteristics can provide a more nuanced understanding of how social relations influence health and well-being of the individual in later life. socioemotional selectivity theory (sst; carstensen, ; carstensen et al., ) is based on and derived from baltes' selection, optimization and compensation model (soc: baltes, ; baltes et al., ) . according to sst, people make active choices about the number and closeness of relationships in which they would like to invest, and older adults become more selective in choosing their social network members due to shifts in motivation (english and carstensen, ) . these shifts in social relations are driven, in part, by perceptions of time rather than age per se. sst is fundamentally a lifespan theory which takes into account different life goals at different points in the lifespan (carstensen et al., ) . younger people are motivated to reach out and explore the world, in part, due to having more expansive time horizons (i.e., open-ended). thus, younger adults strive for more knowledge-focused goals (i.e., achievement, accumulating information, etc.) to gain more independence from their family of origin and seek new connections as they seek to discover their place in the world. as individuals get older, sst argues people perceive their time left to live as more limited. with age, people become less interested in exploring new relationships but rather focus on relationships they already have that are more emotionally meaningful. with this goal dominating the basis of their social relationships, people begin to reduce the number of relationships in which they are invested in order to devote more of their remaining time to their close relationships, which become increasingly significant to them. in an early empirical examination of sst, three cohorts of nationally representative samples were examined. across all three cohorts, younger people reported wanting to increase the number of social relations (e.g., friends) while older people felt they had enough friends and were quite satisfied with the current size of their social networks (lansford et al., ) . experimental data are also supportive. for example, in a cross-sectional study (fredrickson and carstensen, ) investigating social partner selection, individuals were asked who they would spend half an hour of free time with: a member of their immediate family (familiar social partner), a recent acquaintance they have a lot in common with (novel social partner) or an author of a book they read (novel social partner). when asked in the unspecified condition, older adults showed greater preference for familiar social partners compared with younger adults. in contrast, in a condition in which participants were told to imagine they were moving across the country by themselves (i.e., a salient ending condition), younger adults showed similar social preferences to older adults (study ; fredrickson and carstensen, ) . in another study, using the same paradigm as the previous study (fredrickson and carstensen, ) , researchers examined social partner selection in hong kong before, right after and months after the september th terrorist attacks (study ; fung and carstensen, ) . before september th, younger people were less likely to select familiar social partners than older people. right after / , however, age differences were no longer present such that both younger and older individuals showed a preference towards familiar social partners. four months after / , age differences reemerged, showing a greater preference of familiar social partners at older ages (study ; fung and carstensen, ) . further, in a longitudinal study, social partner selection was examined in hong kong during the peak of the sars epidemic and right after it subsided. during the sars epidemic, no age differences in social partner selection emerged, however, after the sars epidemic, younger ages were less likely to select familiar social partners compared with older ages (study ; fung and carstensen, ) . overall, sst highlights the role of motivation, life goals, and context (i.e., perceptions of time left and/or the finitude of life) which influence social relationship preferences. that is, older individuals tend to be more likely to prefer familiar social partners, which may reflect a shift from knowledge-focused goals to emotion-focused goals due to changing perceptions of time horizons. prior research has shown that age is a good predictor of time perception such that older adults show more limited future time perspectives than younger adults (lang and carstensen, ) . however, life events and experimental manipulations can also reduce time horizons (e.g., fredrickson and carstensen, ; fung and carstensen, ) and thus, shifts in motivation and social preferences may occur at any life stage. overall, sst argues that close social relationships become more, not less, important as people age, which may be driven by motivational changes in goals. at the same time and perhaps because of this, people become more selective about their relationships. they prefer to invest what they perceive to be their limited remaining time in relationships that are most important to them. the strength and vulnerability integration (savi; charles, ) model, building on the tenets of sst (carstensen et al., ) , describes age-related gains and losses that influence the process of emotion regulation in older adulthood. in particular, consistent with sst, the savi model addresses the frequent finding that older adults express higher levels of well-being than younger adults. this finding is somewhat counterintuitive in that older adults are known to experience increased susceptibility to the negative consequences of high emotional arousal, such as from conflict and misunderstandings stemming from social relations. to protect themselves from this vulnerability, older adults are theorized to use strategies that allow them to avoid and/or disengage from emotionally laden situations and do so to a much greater extent than younger adults. indeed, prior research has shown that older adults tend to endorse more passive emotion regulation strategies compared with younger adults (blanchard-fields, ) which may have more benefits for health and well-being in later life. for example, in a daily diary study of u.s. adults, older age was associated with less affect reactivity to interpersonal stressors when individuals avoided an argument whereas older age was unrelated to affect reactivity when individuals engagement in arguments (charles et al., ) . this strategy, of avoiding negative social situations, serves to protect the older individual from their known heightened sensitivity to stress and may explain, at least in part, the observed age-related benefits in well-being achieved by avoiding negative social situations. this interpretation was further supported in a cross-sectional study in which younger and older adults were presented with audiotapes of two actors insulting another person in which they were instructed to imagine that the negative comments were directed at them (charles and carstensen, ) . in response to these imagined insults, older adults made fewer cognitive appraisals about the speakers, expressed less negativity and less anger, but equivalent levels of sadness compared with younger adults in response to the overheard insults (charles and carstensen, ) . these findings may indicate that older adults protect themselves by shifting attention away from and disengaging from averse social situations, thus dampening negative responses. in another form of self protection from vulnerabilities and consistent with sst, savi theorizes that older adults maintain social relationships with close others while pruning more peripheral social partners (english and carstensen, ) . this occurs in order to help maintain important, emotionally meaningful relationships and helps to maximize emotional well-being (see review, rook and charles, ) . these changes in social partner selection are another form of self protection, driven not only by perceptions of time left (i.e., sst), but also by accrued knowledge and experience (charles, ) . the amount of time lived may be an important indicator of social expertise (luong et al., ) such that older adults may have more experience dealing with everyday life which allows them to be selective and increase efficiency at dealing with and avoiding potential stressors (charles, ) . savi further expands on sst by highlighting not only age-related gains (i.e., strengths), but also age-related losses (i.e., vulnerabilities). specifically, older adults experience decreases in the body's ability to downregulate strong negative emotional responses that may have consequences for emotional and physical health outcomes (charles, ) . increased difficulty at downregulating sustained emotional arousal and reactivity in older adulthood may, in turn, attenuate age-related improvements in emotion regulation when faced with unavoidable stressors (charles, ) . while many long-term social ties are positive, some are not. negative close social relations often cannot be avoided and may be a source of strain and ambivalence. thus, when older adults are unable to avoid situations that cause high levels of distress, such as conflicts or misunderstandings in social relationships, they are likely to experience arousal that may challenge their health and quality of life (rook and charles, ) . for example, in a classic finding rook ( ) found that negative relations had a more powerful effect on well-being than positive relations. in a related longitudinal study of british adults aged to , negative social interactions were more strongly associated with physical health with older age (hakulinen et al., ) . overall, the savi model builds on the foundation of sst, further highlighting the age-related gains and losses associated with maintaining emotional well-being. notably, the savi model posits that older adults actively down regulate emotional stress, avoid high arousal circumstances and/or limit their reaction to those circumstances whenever possible. this approach offsets the increased vulnerability of older people to stress and its negative effects on health and well-being. these strengths and vulnerabilities, in turn, may influence the selection of social network members (i.e., social pruning) as well as how individuals choose to interact during social contexts (i.e., avoiding interpersonal stressors/conflicts). each of these theories are lifespan in nature and offer accumulating evidence concerning individual and specific important insights concerning the who, what, why, and how of social relations. the convoy model of social relations offers an overarching, inclusive theory meant to identify specific aspects of social relations (i.e., structure, support and satisfaction) while also detailing what and how personal and situational characteristics influence the individual's needs for specific aspects of social relations. all antecedent elements of the model influence consequences for the individual in terms of health and well-being outcomes. on the other hand, socioemotional selectivity theory focuses on what motivates individuals to seek and invest in relationships, and specifically what influences exactly the types of relationships in which people will invest (e.g., new vs. old, close vs. distant). sst argues that people are motivated by goals which are affected by circumstances (e.g., time, place and context). this, in turn, influences the choices people make about with whom they choose to spend their time. finally, the strength and vulnerability integration model drills down even further the how and why of social relationships. specifically, savi examines the strategies people, especially older adults, use to avoid extremes of emotions and maintain emotional regulation. this is accomplished by maximizing the positive and minimizing the negative in their relationships (i.e., how) thus avoiding emotion regulation problems often caused by and associated with the stress and strain of difficult relationships and/or circumstances (i.e., why). each theory offers guidance about specific aspects of social relations. some theories motivate specific research questions whereas others guide the interpretation of research findings. while the convoy model provides a heuristic framework within which to understand the causes and consequences of social relations over the life course, sst focuses on the individual's time perspective and what motivates social interactions while the savi model specifies a common strategy among older adults used to maintain high levels of well-being through emotion regulation and avoidance of conflict. in the paragraphs below we use these theories to interpret findings that address common dimensions of social relations, relationship types, and means of communication. finally, we end with a consideration of clinical applications and future recommendations. the extent to which people engage with, and receive benefits from, their social relations is influenced by structural, functional, and qualitative aspects of their relationships (holt-lundstad, ) . structural aspects refer to the objective components of the network that are directly observable, such as total network size, age of, gender, relationship to and frequency of contact with network members. supportive or functional aspects of social relations refer to the exchange of aid (e.g., tangible goods, instrumental support), affect (e.g., emotional support, affection), and affirmation (e.g., confirmation of values; informational support). on a more evaluative level, qualitative aspects of social relations are those pertaining to one's subjective experiences of interactions with others in their social networks such as satisfaction, enjoyment, strain or conflict with their relationships. one example of the distinction between structural and qualitative aspects of social relations can be found in the growing literature on social isolation versus loneliness (cacioppo and hawkley, ) . social isolation refers to the lack of network members and the lack of support exchanges and corresponds to the objective, structural and functional aspects of not receiving support. in contrast, loneliness refers to the distress experienced or the individual's personal assessment that they are not sufficiently supported by others. that evaluation of a lack of support results in low levels of satisfaction which corresponds to a low evaluation of the quality of their relationships. it should be noted that quality of relationship is a subjective evaluation in that two people with the same support exchanges might evaluate those support exchanges differently, which would then have different effects on health outcomes (van tilburg et al., ) . greater specificity of structural, functional, and qualitative aspects of social relations has significantly contributed to a better understanding of how social relations influence health in older adulthood. the following sections explicates specific ways in which structural, functional, and qualitative aspects of social relations distinctly contribute to health-related outcomes. in this section, we frequently highlight cognitive health as illustrative both because of its overall importance and link to alzheimer's disease and because significant advances have recently been made demonstrating the association between social relations and cognitive functioning in numerous populations around the world. social network size is a commonly used indicator of network structure which has been shown to be related to physical (i.e., mortality; berkman and syme, ; kauppi et al., ) and cognitive health (barnes et al., ; bennett et al., ) outcomes in older adulthood. for instance, in a clinicopathologic study examining social network size, cognitive functioning and brain pathology at autopsy, individuals with a larger social network showed attenuated associations between brain pathology and cognitive functioning. in other words, even when individuals had more severe levels of brain pathology, cognitive function remained high for participants with larger social networks whereas individuals with a smaller social network showed lower cognitive function at higher levels of brain pathology (bennett et al., ) . these findings suggest that social network size may be a source of cognitive reserve and may contribute to the maintenance of cognition, in spite of neuropathology. additionally, a cross-sectional investigation of the role of network size on cognition using a cohort of u.s. older adults by katz and colleagues (katz et al., ) found that social network size was significantly related to executive functioning but this association varied by race and ethnicity. they reported that the strongest associations existed between executive functioning and quadratic estimates of the number of close children of non-hispanic black participants, and number of close family members for hispanic participants. on the other hand, among black participants, a curvilinear relationship indicated that less than or more than two close children was associated with lower executive functioning. this was not the case for hispanic participants, among whom higher executive functioning was associated with fewer ( - ) and greater ( - þ) numbers of family member contacts. prior research has also shown the potential benefits of contact frequency for health and quality of life. a recent study by grant and colleagues (grant et al., ) who followed a sample of middle aged adults in britain, showed that people reporting less contact with network members had higher salivary cortisol upon waking and throughout the day, compared with those in more frequent contact with their network members. these findings suggest that less frequent contact with network members, which could be an indication of social isolation, negatively affects the stress response of the body. as is perhaps evident, this has important implications for other health outcomes. indeed, less contact frequency has been associated with higher mortality (berkman and syme, ) . as reviewed in more detail later, this biochemical response to social isolation may be one way by which contact frequency contributes to physical health. in a related longitudinal study of american adults by seeman and colleagues, higher frequency of contact was associated with better executive functioning and better memory while decreases in contact frequency over two time points was associated with worse memory (seeman et al., ) . this study was unique in that it began to specify exactly what dimensions of cognitive functioning are influenced by contact frequency. similarly, zahodne and colleagues (zahodne et al., a) , using longitudinal data from a u.s. nationally representative sample of older adults, found that more contact was associated with better memory at baseline and slower memory decline over years. on the other hand, social network size was not associated with memory trajectories (zahodne et al., a) . these findings suggest that it is the stimulation of social contact rather than the number of social ties which positively affects cognitive functioning among older people. these authors also examined the reverse, to see whether memory was associated with changes in social contact over the same span of time. it is noteworthy that they report no association between memory and change in contact frequency (zahodne et al., a) , indicating that it is the loss of social relations that is detrimental to cognitive health, rather than declines in cognitive health leading to more isolation. another important structural characteristic of social relations can be measured by the number of social activities in which an individual engages. number of social activities and/or groups represent a form of structural ties. these appear to be beneficial to cognitive health as they help increase the number of weak ties (i.e., peripheral social ties such as neighbors, acquaintances, etc.) in the social network. these activities seem to promote health through the requirement of active contingent interaction and allocation of resources through the exchange of support (i.e., see in-depth discussion regarding the strength of weak ties in the next section). social activities are those that involve actively interacting with others, such as playing cards, going to church, or playing a competitive sport, and these activities may have implications for health in older age. prior research has found that social activity was associated with less disability at baseline and slower decline in function over years (mendes de leon et al., ) . similarly, in another study, barnes and colleagues (barnes et al., ) reported that more frequent social activity was associated with baseline global cognitive function and slower decline in global cognition over time, independent of network size. furthermore, the number of different types of social groups with which one engages may also be beneficial for health given that number of social groups is associated with increased network size (hawkley et al., ) . the above examples and prior research have shown promising links between structural aspects of social relations and health outcomes. it is important to note, however, that these various structural aspects of social relations work in tandem with other aspects of social relations. just as there are structural aspects of social relations, functional support or the exchange of support as well as qualitative aspects of social relations are important components of social relations that merit further discussion. these functional and qualitative aspects of support may also be independently associated with health. functional or social support refers to the actual support that is exchanged and can be subcategorized by whether the support provided included practical aid (e.g., instrumental/tangible support), affect (e.g., emotional/affectional needs) and/or affirmation (e.g., verification of values) (kahn and antonucci, ; krause, ) . social support has been shown to be associated with a wide variety of physical and mental health outcomes. for example, an irish longitudinal study of older adults found a negative association between social support and depressive symptoms. of note, this pattern of findings varied across men and women, with higher levels of spousal support and less strain from one's spouse as well as better social network integration being protective against depressive symptoms only in men (santini et al., ) . further, there were no associations between support and anxiety for either men or women, suggesting that functional aspects are more impactful for mood compared to anxiety (santini et al., ) . another longitudinal study similarly found that baseline social support and change in social support over years were both related to depressive symptoms in that more support was related to fewer depressive symptoms, but loss of support was related to more depressive symptoms (oxman et al., ) . in regards to cognitive health, in a longitudinal study of american older adults, no associations between baseline social support and change in cognitive function was found; however, the authors did find an association between satisfaction with social support (i.e., quality) and global cognitive function and processing speed/attention at baseline . social support may also facilitate increased physical activity in older adults, which may be another way of promoting health and well-being over time. for instance, in a study of south korean older adults, social support was related to increased physical activity (kang et al., ) . this increase may be due to the increased accountability and companionship that comes with joint physical activity, which can help older adults be more motivated to adhere to fitness regimens and other healthy behaviors to promote overall quality of life. examining an outcome such as physical activity engagement may be an area where the type of support given and received can be further disentangled as the reciprocal benefits of support given and support received may have mutually beneficial health outcomes. it is important to note, however, that individuals can both receive and provide social support to network members and these may have distinct effects on health in later life. for example, in a study by thomas ( ) , when simultaneously modeling support received, support given, and other aspects of social relations, the authors found that psychological well-being was positively associated with support given, while support received was not associated with psychological well-being. these findings suggest that when considering indicators of psychological health, it may be more important to consider the effects of support, both given and received, in order to identify more salient effects of social relations on mental health outcomes. to this point, a study by lafleur and salthouse ( ) found that providing both informational and emotional support were beneficial for memory. a similar pattern of findings has also been demonstrated internationally. specifically, in a longitudinal study examining older adults in southwestern france, independent of other indicators of social relations such as network size, receiving more support than giving support was associated with lower odds of dementia incidence (amieva et al., ) . of note, another longitudinal study of american older adults found that emotional support received was independently associated with change in overall, better cognitive performance after accounting for other indicators of social relations, including perceptions of support given by the participant (seeman et al., ) . in this same study, authors found that the effect of support given as indicated by a measure asking about frequency of instrumental and emotional support given, was not associated with cognition at baseline or change in cognition over two times points. combined, these studies highlight the importance of the type of functional support exchange to improve health, and that the effect of giving support may not be equally associated with positive health outcomes as support received in similar types of support exchanges. the quality of one's social relations may have a unique effect on later life health outcomes. social strain, a distinct negative qualitative aspect of social relations, can be described as the degree of interpersonal conflict and/or obligatory interactions (i.e., family obligations), that results in the person perceiving increased dissatisfaction and distress from these interactions (yang et al., ) . prior research has linked social strain in older adulthood to health-related outcomes. for example, in the study mentioned above by antonucci and colleagues investigating the links between social strain and health, under conditions of serious illness, the strength of positive and negative interactions with network members was associated with mortality in a somewhat counterintuitive manner. stronger negative interactions were related to lower mortality as were weaker positive interactions. on the other hand, a study of danish middle aged adults, always or often experiencing social strain had higher risk of mortality compared with those who reported seldom experiencing these strains (lund et al., ) . in a longitudinal study, seeman and colleagues (seeman et al., ) investigated a cohort of american older adults and found that more social strain was independently associated with worse executive function while accounting for other social relations. of note, these authors did not find measures of quality of social relations to be related to change in cognitive function over time (seeman et al., ) . recall that in the longitudinal study of irish older adults mentioned above examining associations of social strain with depressive and anxiety symptoms, a positive association between social strain and depressive symptoms but no association between strain and anxiety was found (santini et al., ) . together these studies suggest that while strain may have overtly negative health consequences, there may be aspects of interacting with others that may be protective, indicating that further study into the mechanisms underlying the association between social strain and health is warranted. because of the ways that social strain affects mental health, physical health, and cognitive health, studies have also found that qualitative aspects of social relations are associated with increases in similar biochemical processes in the body. in a study examining social strain and risk of elevated inflammation using a composite of five indicators of inflammation (c-reactive protein, fibrinogen, interleukin- , e-selectin, intracellular adhesion molecule ), social strain was independently associated with increased risk for elevated inflammation (yang et al., ) . further, the effect of social strain was stronger than the effect of social support, confirming rook's ( ) finding and suggesting that the presence of social strain may be more detrimental to health than the absence of social support (yang et al., ) . these findings provide some insight by which social strain can affect physical and mental health outcomes. as the convoy model suggests, both personal and situational characteristics influence the structure, function and quality of life. one manifestation of the situation is culture, which can fundamentally influence expectations and evaluations of social relations. what may be seen as social support in some cultures, may be perceived as social strain or conflict in others. their detrimental effects may then depend on the cultural norms as well as how closely individuals identify with a particular culture and adhere to its norms. as an example, collectivistic cultures may view responsibility of family members, particularly responsibility to older adults, to be important in family relations. a qualitative study by willis ( ) explored this topic in a study on caregiving of older adults in britain around ethnic identity and duty to elders in examining the effects of collectivistic cultures. those who identified with their ethnic group membership, and whose ethnic group valued service and support of elders as one behavioral indicator of collectivistic culture, were more likely to indicate agreement that younger generations should take care of their elders. in this study of largely ethnic minorities, minorities of south asian descent and white irish immigrants endorsed beliefs consistent with collectivistic ideals of taking care of elders, while white british older adults did not endorse these beliefs (willis, ). an international comparison of perceived filial piety (i.e., responsibility for elders) in five european countries, germany, israel, norway, spain, the united kingdom and the united states similarly found that sense of filial piety depended on the collectivist versus individualist orientation of the european country and, in the case of the united states, the ethnic/racial background of the respondents (jackson et al., ) . although perception of obligation regarding elder care may be either individually or culturally based, an elder who perceives a younger person as not adhering to those elder care norms may experience their relationship as strained when these expectations are not met. quality of relationship, as noted above, refers to the individual's evaluation of their social relationships. thus, people with the exact same amount of exchanges (functional support) and number of relationships (structure of social network) can feel differently about the quality of their relationships. one might feel their relationships are perfectly adequate, another might feel dissatisfied with the same relations and, instead of being content with them, feel quite lonely. thus, loneliness is differentiated from structural network characteristics, such as social isolation, and functional characteristics such as support received, in that it is the individual's evaluation of satisfaction with their social relations that affects health and emphasizes the person's negative emotional reaction to their dissatisfaction with the quality of their social relations. loneliness, in particular, may be a salient example of the importance of investigating quality of social relations. increased loneliness in older age has been linked to a number of mental health, physical health, and cognitive outcomes. for example, more loneliness is associated with increased depressive symptoms over time . loneliness has also been associated with poorer physical health, as indicated by increased physical disability (shankar et al., ) , hypertension , and increased mortality (patterson and veenstra, ) . furthermore, individuals who reported often feeling lonely had a higher risk of mortality due to non-ischemic cardiovascular diseases, compared with those who reported never feeling lonely, when accounting for other aspects of social relations (patterson and veenstra, ) . the odds of non-ischemic cardiovascular mortality were higher than all-cause mortality, suggesting that loneliness's impact on cardiovascular health may be a leading cause of death (patterson and veenstra, ) . indeed, other studies have examined loneliness and cardiometabolic disease and demonstrated that increased risk of metabolic syndrome (e.g., waist circumference, triglycerides, high density lipoprotein cholesterol, blood pressure, and fasting glucose; whisman, ) is associated with higher amounts of loneliness. loneliness may also impact cognitive health in older adulthood. while one cross-sectional study with an american sample of racially and ethnically diverse older adults did not find an association between a comprehensive measure of loneliness and episodic memory when accounting for structural aspects of social relations and other psychosocial factors (sol et al. under revision) , another cross-sectional study with an irish sample did find an independent association between loneliness and global cognition, processing speed, and visual memory when accounting for social network integration (o'luanaigh et al., ) . in a recent longitudinal study of social activities among chinese older adults, an independent association emerged between loneliness and global cognitive decline over years, among those engaging in more frequent social activities (zhong et al., ) . loneliness has also been associated with increased inflammation, important as inflammation is often associated with all of the aforementioned health outcomes (kiecolt-glaser et al., ) , including cognitive function (zahodne et al., b) . increased inflammation is one of the mechanisms proposed by hawkley and capitanio ( ) , as to how loneliness affects health. thus, further study of the biochemical mechanisms between loneliness and various health outcomes may also provide insight into ways to reduce its detrimental effects in older age. additional specification is suggested in a recent study by kang and colleagues (kang et al., ) who found that while physical activity did not mediate the relationship between social support and quality of life, the positive relationship between social support and quality of life was mediated through a negative relationship with loneliness. these findings show how other aspects of social relations (i.e., functional exchanges/ support) can affect health outcomes through qualitative factors (i.e., loneliness). furthermore, when modeling both social isolation and loneliness concurrently, their relative impact may depend on the outcome studied, as social isolation may be related to increased likelihood of poorer self reported health, while increased loneliness may be related to increased likelihood of poorer mental health (coyle and dugan, ) . taken together, these studies highlight the complexity of various aspects of social relations and loneliness and how they each contribute to overall health. as loneliness may be a potential risk factor for health and quality of life in older adulthood, understanding the antecedents of loneliness may be an important area for future intervention. several factors may contribute to the experience of loneliness. previous experiences of loneliness may be one predictor which leads to a cyclical pattern of behaviors which results in additional feelings of loneliness over time (cacioppo and hawkley, ) . personality influences social relationships and these relatively fixed characteristics may contribute to the cycle of loneliness, particularly characteristics indicating neuroticism (buecker et al., ) . nonetheless, other research has found that levels of neuroticism decrease over the life course (ormel et al., ) , which is promising as older adults who experience elevated levels of neuroticism earlier in the life course may be able to seek and maintain the relationships they desire in order to reduce loneliness. taken together, these concepts and the related studies show the importance of examining not only the structural aspects of social relations but also the exchange of support and the subjective or evaluative aspects of social relations. consistent with the tenets of the social convoy model, this evidence helps identify why structural aspects of social relations are important given its emphasis on the observable aspects of social networks and the ways in which these observable aspects influence health over the life course. in addition, this evidence helps identify why structural characteristics such as network size and frequency of contact contribute to health because the presence of others and contact with them is essential to developing the relationships critical to health. further, an examination of the distinct dimensions of social relations helps identify ways in which the qualitative aspects of relationships helps to motivate reasons for maintaining contact in older age in order to better invest limited time with more meaningful relationships, as proposed by and consistent with socioemotional selectivity theory. similarly, the links between higher quality social relations and health outcomes supports the tenets proposed by the savi model, which suggest that maintaining contact with desired others and pruning unwanted relationships reinforce positive emotional experiences with desired others. these motivations to protect limited time (i.e., sst) and to increase positive emotional experiences (i.e., savi) can be in the form of both support/functional exchanges as well as perceived relationship quality. given that none of these aspects of social relations exists in isolation nor are easily separable, future work can further refine understanding on the ways in which structural, functional, and evaluative aspects of social support may improve overall health. understanding the nuances underlying social relations may also help improve interventions that target improving structural, functional support exchanges, and qualitative aspects of social relations in order to better meet and resolve older adults' specific needs in social relations. further, structural and functional aspects of social relations such as social isolation and support exchanges, as well as qualitative aspects such as loneliness, are specific ways in which social relations affect health. examining these various components of social relations together may help improve future study into ways to increase the beneficial aspects of social relations while reducing those characteristics of social relations that negatively affect health in older adulthood. as we seek to understand the association between social relations and health, it has become clear that specific social relationships may provide unique forms of interaction and support. in the following sections, we highlight the characteristics and importance of several types of social relations and their unique impact on later life health. we highlight ( ) the importance of early-life social relationships with parents and peers, ( ) the importance and distinctions between friends and family, and ( ) the role of weaker social ties such as fellow church members and neighbors in older adulthood. prior research focusing on social relationships in later life as well as a majority of the research covered in this chapter predominantly focus on the associations between current social relationships and health outcomes in older adulthood. it should be acknowledged, however, that social relationships grow and develop across the lifespan. specifically, social relationships in childhood play a critical role in developmental processes that have been shown to have far reaching effects on social, mental, physical and cognitive health in adulthood. as theorized in attachment theory and the social convoy model, social relationships build from previous social experiences (antonucci et al., ; bowlby, ) . specifically, attachment theory argues that children develop internal working models of attachment (i.e., a representation of one's self and of relationships in general) that will guide expectations and behaviors exhibited in future social relationships (see chapter, siegler et al., ) . indeed, prior research examining attachment of white middle-class infants at months old showed that a majority of the infants ( %) received the same secure/insecure attachment classification in early adulthood (waters et al., ) . therefore, early life relationships with parents and important others may have far reaching effects on health and quality of life through late life current social relationships. further, prior research also suggests that early life social relationships may influence health more directly through the development of physiological stress response (luecken and lemery, ) . that is, children who have poorer quality relationships with parents may be hypervigilant to threat cues in their environments, may exhibit poor self-regulatory responses (i.e., maladaptive coping strategies) and elevated physiological stress responses (see reviews; luecken et al., ; luecken and lemery, ) . in line with this notion, prior research has linked parental social relationships to a variety of health outcomes later in life. for example, in a cross-sectional study of u.s. adults examining the associations between retrospective childhood social support and allostatic load measured by a sum of risk scores across physiological systems, higher social support in childhood (emotional and instrumental) was associated with less biological dysregulation in midlife (slopen et al., ) . consistent with these crosssectional findings, a longitudinal study of harvard undergraduate men found that lower ratings of parental caring in young adulthood was associated with greater risk of illnesses such as coronary artery disease, hypertension, duodenal ulcer, and alcoholism years later (russek and schwartz, ). an examination of the influence of early parental relationship quality on cognitive health outcomes by sharifian and colleagues revealed that respondents from a nationally representative u.s. sample of older adults who reported higher retrospective maternal relationship quality showed less decline in episodic memory over time through reduced loneliness and depressive symptoms. similarly, in a population-based longitudinal study of non-hispanic african american and white adults, greater retrospective childhood social support was associated with better initial memory through educational attainment and mental (stress) and physical (bmi) health pathways (zahodne et al., c) . these findings highlight the enduring effects of early life social relationships on health-related outcomes directly and indirectly through multiple biopsychosocial pathways. in addition to parental relationships, peer relationships in childhood and adolescence may also have long-term implications for health. peer relationships become especially salient as individuals begin to spend more time with age peers in adolescence and begin to value expectations of peers more highly (see chapter, brown and larson, ) . social acceptance by peers has previously been identified as a reliable indicator of socioemotional and behavior adjustment outcomes and are thought to have long-term ramifications for developmental processes over the life course. for example, in a -year prospective swedish cohort study, peer problems at age , defined by perceived degree of unpopularity and social isolation at school, were linked to greater risk of metabolic syndrome at age (gustafsson et al., ) . this finding was robust after accounting for health behaviors, school adjustment and family circumstances in adolescence as well as psychological distress, health behaviors and social circumstances in adulthood (gustafsson et al., ) . peer bullying specifically has also been associated with a variety of health-related later outcomes. for example, in a longitudinal study following american children into young adulthood, being a victim of bullying as well as being a bully-victim (i.e., someone who is bullied and is also a bully) was associated with increased risk of poorer health, socioeconomic and social-relationship outcomes in adulthood (wolke et al., ) . consistent with the previous study, in a -year prospective follow-up of a british birth cohort, bullying victimization in childhood (ages and ) was associated with worse mental, physical, and cognitive health outcomes in midlife (takizawa et al., ) . findings specific to adult social relationships indicate that bullying in childhood was associated with weaker social relationships in adulthood (takizawa et al., ) and support the hypothesis that later-life social relationships are based on and develop from earlier relationships such as interactions with adolescent peers. these findings are consistent with the social convoy model and attachment theory, suggesting that parental relationships in childhood and peer relationships in adolescence may act as building blocks for developmental processes in later life. specifically, early life social relationships may influence current and later life health outcomes (i.e., mental, physical, cognitive) through the early development of internal working models of attachment. these early life social relationships may also influence health outcomes through their impact on threat appraisal, self-regulatory and physiological responses to stress (luecken et al., ; luecken and lemery, ) . additionally, although not discussed in detail in the current chapter, early life social relationships with parents have been linked to self-regulatory behaviors in childhood (eisenberg et al., ) and in early adulthood (baker and hoerger, ) . thus, children and adolescents who develop appropriate self-regulatory skills in childhood are likely to show better regulation skills later on in life. this may be an important individual difference that influences emotion regulation strategy selection and efficiency in order to avoid age-related vulnerabilities to high arousal situations (i.e., conflicts, misunderstanding) as conceptualized within the savi model. in light of the above summarized findings, we conclude that it is important to consider not only current characteristics of social relations in older adulthood, but also significant social relationships at pivotal developmental periods. an ongoing issue in the field of social relations is the relative importance of family and friends as well as their association with health and well-being, especially in later life. when prior research has compared the distinct effect of friends and family, friendships are often shown to more strongly benefit later life health and quality of life. for example, in a cross-sectional study across countries, valuing both family and friendship relationships was associated with better health and higher happiness, however, valuing friends became a stronger predictor of health and happiness at older ages (study , chopik, ) . in a longitudinal follow-up study of u.s. older adults, friendship strain was associated with more chronic illness over time. at the same time, support and strain from spouse, children and friends predicted subjective well-being whereas other family relationships (i.e., relatives other than spouse and children) were not associated with health or well-being (study , chopik, ) . similar patterns were also evidenced in studies examining cognitive health outcomes. for example, in a cross-sectional study of chinese nonagenarians and centenarians, the number of friends and being married, but not the number of children or ties with neighbors, were associated with better cognitive health (wang et al., ) . finally, in a recent longitudinal nationally representative study of u.s. older adults, more frequent contact with friends, but not family, was associated with less decline in memory over time (zahodne et al., a) . these converging findings may reflect the distinct features of friendships versus familial ties. friendships can be seen as more voluntary in nature. as individuals actively select their friends, friendships may provide different resources compared with family ties that help to promote health and quality of life. for instance, friendships are often reported as a greater source of companionship in later life, especially in comparison to family ties (crohan and antonucci, ; quan-haase et al., ) . they may, therefore, influence later life health through shared activities and mutual interests. indeed, prior empirical research has shown activity engagement to mediate the association between friendships and health. for example, in a cross-sectional study of swiss older adults, higher engagement in leisure activities mediated the association between a higher number of close friends and higher cognitive functioning (ihle et al., ) . similarly, evidence from a longitudinal study of u.s. adults showed that higher contact frequency with friends, but not family, was associated with higher engagement in cognitive and physical activities, both of which were associated with higher episodic memory and executive functioning . this pattern of findings has also been demonstrated when examining socioemotional outcomes. for example, in a nationally representative longitudinal study of germans, informal social activities with friends were associated with better subjective well-being (i.e., higher positive affect, lower negative affect, and higher life satisfaction) in older adults. in contrast, informal social activities with family were only associated with an increase in positive affect and an increase in negative affect in older adults (huxhold et al., ) . using experience sampling, a study of older canadian adults found that when older adults reported being in the company of friends, they also reported more positive subjective well-being compared with when they were with family (larson et al., ) . this finding may be partly attributable to the types of activities individuals engage in with friends versus family. specifically, when with family members, older adults reported higher engagement in maintenance activities (i.e., housework) and passive leisure activities (i.e., watching television). in contrast, when with friends, older adults reported higher engagement in more active leisure activities such as hobbies, religious/cultural engagement, and sports (larson et al., ) . these findings are also consistent with the notion that friendships bolster activity engagement. family ties, in contrast to friendships, may be viewed as more obligatory in nature. family ties are more permanent relationships with less autonomy at selection (dono et al., ) and are sometimes seen as a burden (crohan and antonucci, ; quan-haase et al., ) . despite friendships often being viewed as a better source of companionship, family ties may be a better source of longterm social support which is critical to maintaining one's quality of life in older adulthood. illustratively, a cross-sectional study of older adults found that family members were identified as greater sources of social support (instrumental and emotional) and social control (i.e., efforts to promote healthy and deter risky health behaviors), whereas friends were identified as greater sources of companionship (rook and ituarte, ) . in another cross-sectional study, older adults' expectations for assistance (i.e., services and resources) from family exceed expectations from both close and casual friends. older adults were more likely to endorse expectations that family should help with tasks such as providing shelter, money, unsolicited advice or put themselves at risk for the older adult (mancini and simon, ) . of note, reported expectations of family and close friends for intimacy (i.e., feelings and emotions) and social integration (i.e., shared experiences, companionship) were similar (mancini and simon, ) . examining a group of older women hospitalized for congestive heart failure in the past year, friedman ( ) found that women who reported emotional support from family and women who reported emotional support from both family and nonfamily (i.e., friends/neighbors) had higher positive affect than those who reported support only from nonfamily (friedman, ) . similarly, women who reported tangible support from family and women who reported tangible support from both family and nonfamily had greater life satisfaction than those who reported only tangible support from nonfamily (friedman, ) . consistent with cantor's ( ) hierarchy of support, friedman suggested that older women who are ill may feel more satisfied with tangible assistance that comes from family, as it aligns with their expectations and norms (i.e., more appropriate to receive this type of help from family rather than nonfamily). family ties may provide more long-term assistance and support to help older adults that may not be seen as appropriate for non-family ties to provide. antonucci ( ) suggested that people develop a support bank, an informal accounting of what is given and what is received over time from individuals specifically and more generally. it may be that the long-term nature of family relationships means that older people feel that they are more entitled to support from family members as they are more likely to have provided support to these same or related individuals in the past. this is consistent with findings indicating that older adults report that major support services such as caretaking are more commonly expected of family relationships relative to other types of social relationships (quan-haase et al., ) , and family members represent more appropriate social ties to help with more long-term issues (cantor, ) . in sum, the importance of both family and friends relationships across the lifespan for health and quality of life is clear. less clear, however, is the relative importance of friends versus family (i.e., which is more important?). from a developmental and clinical scientist perspective, it seems most likely that both are important and play different roles, especially in late life. much as motherinfant attachment provides the secure base from which infants discover and explore the world, it appears that close family relations provide a secure base for adults as indicated by the fact that they are known to be a comforting source of instrumental as well as emotional support. with regard to peer relations, it appears that older people are more likely to turn to friends for companionship and leisure activities. both types of relationships contribute in important and significant ways to health and quality of life. with age and a more limited future time perspective, sst would predict that people spend more time with close family and begin to limit interactions with friends. the nature of families and the availability of friendships are idiosyncratic and thus likely to vary depending on specific circumstances. overall, family relationships and friendships occur in very different contexts (i.e., friends outside the home, family within the home, etc.) and situations (i.e., for leisure, during health crises, etc.) and may therefore influence later life health through different pathways. although close social relationships with friends and family are important for successful aging, other more peripheral social ties, such as those with fellow church members, neighbors and acquaintances, may also provide beneficial resources in later life. the strength of weak ties as proposed by granovetter ( ) posits that weak ties may provide unique forms of support in times of need. specifically, weak ties can link individuals to resources to which they might not normally have access and may also provide contrasting views and information not available from strong ties (granovetter, ) . weak ties may also provide unique types of support that only geographic proximity and shared communities can, such as a neighbor having a spare set of house keys (dono et al., ) . indeed, in a longitudinal study following u.s. adults over a -year period, although close and weaker ties were both associated with a reduction in depressed affect, the number of weaker social ties was more strongly associated with maintaining a low level of depressed affect over time than the number of close social ties. weaker ties were also more strongly associated with maintaining positive affect over time compared with close ties (huxhold et al., ) . although prior research suggests that older adults reduce the number of peripheral social ties (sst & savi), the convoy model outlines different personal and situational characteristics predicting the types of social ties an individual needs. weak ties are likely useful under those personal and situational circumstances that indicate needs not readily met by stronger social ties. while other forms of weak-ties exist, we specifically highlight two that may be particularly relevant for older adults as illustrative examples: church-related ties and neighbors. religious involvement may be an avenue by which the strength of weak ties has a powerful impact on the individual. prior research has linked religious attendance to physical (ferraro and kim, ; krause, ) and cognitive health outcomes (hill et al., ; kraal et al., ) . for example, in a longitudinal study investigating religious involvement and c-reactive protein (a biomarker for cardiovascular disease risk and progression), higher religious attendance was associated with less increase in c-reactive protein in black, but not white, older adults (ferraro and kim, ) . similarly, in a cross-sectional study of white and black american older adults, individuals who received more church-based social support also reported better health, and these associations were stronger in black older adult participants (krause, ) . an investigation of a third us minority group, mexican american older adults, found that those who attended church monthly, weekly and more than weekly showed slower rates of global cognitive decline (mmse) than those who did not attend church (hill et al., ) . similarly, kraal et al. ( ) found in another longitudinal study of american older adults that higher religious attendance and more private prayer were associated with better concurrent memory functioning, even after accounting for nonreligious social participation. further, higher religious attendance and private prayer among black and hispanic older adults partially reduced the magnitude of racial and ethnic inequalities in memory, which suggests that religious involvement may be an important protective resource for racial and ethnic minorities . overall, individuals who are part of a church community may reap health benefits through feelings of belongingness or social support from these community members. further, church members may benefit health outcomes through social control, such that church members encourage healthy behaviors and discourage risky health behaviors. for example, in a cross-sectional study examining older samoan women who attended churches in los angeles county, informal, church-based ties increased the likelihood of utilizing preventive health services, including having a recent mammogram and planning to have a future mammogram (levy-storms and wallace, ) . consistently, in a study of malawi congregations, unmarried adolescents who were frequently exposed to messages about hiv/aids prevention within their congregations had higher odds of abstinence (trinitapoli, ). additionally, married individuals were more likely to be faithful in congregations in which leaders monitored sexual behaviors, and individuals were more likely to use a condom in congregations where leaders privately advised members to do so (trinitapoli, ) . in summary, fellow-church members and congregational leaders in one's network may be a distinct source of support and increase feelings of community and may, in turn, influence health-related behaviors that have a beneficial effect on health and quality of life. neighborhoods, specifically social relationships with neighbors, may be especially important in later life as older adults spend more time within their homes and communities (horgas et al., ; spalt et al., ) due to social role shifts (i.e., retirement) and changes in health and mobility. neighborhood social cohesion is often defined as feelings of mutual trust and solidarity among neighbors and the perception that neighbors are willing to do the right thing. prior research has indeed shown that in a nationally representative sample of american older adults, higher perceived social cohesion was linked to better physical health outcomes (i.e., stroke; kim et al., ) , and better cognitive outcomes (i.e., verbal fluency; zaheed et al., ) . these findings have been replicated in other populations, including among racial and ethnic minorities. for instance, in a cross-sectional study of south asian (india, pakistan, bangladesh, nepal, sri lanka) adults living in the united states, higher social cohesion was associated with lower prevalence of hypertension in women, but not men (lagisetty et al., ) . in another cross-sectional investigation, higher perceived social cohesion was associated with better global cognition, better episodic memory, and better executive functioning in chinese older adults living in the united states (zhang et al., ) . neighbors may be a unique source of informal support that helps to facilitate aging in place and the maintenance of life quality due to their close physical proximity. it has been argued that neighbors may help with short-term instrumental tasks particularly in times of emergency or as health and safety monitors (i.e., signs of an intruder or accident; dono et al., ) . illustratively, older residents of new york city identified neighbors as potential sources of informal social support when family was not available. a majority of the sample reported knowing one or more neighbors well and that these individuals would help each other out for specific tasks. neighbors tend to help out with short-term and/or emergency related tasks such as assistance with shopping when ill or in inclement weather and are readily available to sit or chat, whereas other more long-term tasks were often left up to family (cantor, ) . similarly, in a qualitative study examining older adults living in a naturally-occurring retirement community (norc), neighbors were described as being helpful for particular types of tasks, such as cooking, shopping, or transportation, but were thought of as inappropriate for other tasks like financial or personal issues (greenfield, ) . overall, neighbors, although often viewed as weak social ties, provide immediate help and compensate for non-available family members. in addition to providing small, short-term instrumental assistance for older adults they may also provide the opportunity for older adults to reciprocate, thus contributing to a feeling of community belongingness. available evidence indicates that different relationship types offer distinct benefits for health and quality of life and, as shown in fig. , may operate through several distinct pathways. specifically, social relations in general may influence health and quality of life by promoting healthy behaviors (i.e., exercise, going to a doctor, etc.), increasing engagement in stimulating activities (i.e., leisure activities, hobbies, etc.), helping to alleviate stress (i.e., emotional and tangible social support), and providing access to novel information and resources. when examining which pathways each relationship type might operate through, prior research suggests that friends may be a greater source of companionship whereas family may be a greater source of long-term social support and care. further, more peripheral network members also bring about health benefits, for example when neighbors and fellow-church members provide short-term support or access to diverse informational resources. early-life social relationships, such as those with parents and peers, may influence emotional, physical, and cognitive health outcomes through social functioning. that is, consistent with attachment theory and the convoy model, early-life social relationships may be foundational and influence the development of subsequent social relationships in adulthood (i.e., romantic relationships, friendships, etc.) but may also directly impact health and quality of life through the development of physiological stress response patterns. still, despite prior research examining the complexities of social relationships and their implications for health and quality of life, further investigation is necessary to fully disentangle these unique associations of each relationship type. first, future research would benefit from greater attention to life course processes. informed by the convoy model, social relationships occur across the lifespan, and early life relationships may be foundational for the development of future social relationships. although retrospective data regarding early life social relationships have been linked to later life outcomes, scarce prospective research has utilized observed mother-child or peer interactions to alleviate concerns about recall bias. second, future research should focus on the underlying pathways in which social relationships may confer health benefits, specifically with regard to distinctions between friends versus family, in order to clarify intervention targets. finally, given differences found in specific ethnic and racial minority groups, the need for more representative samples is necessary to assess whether the same pattern of findings is consistently found across sociodemographic groups and cultural contexts. the structure of families and the expectations of friends versus family may differ depending on cultural norms. the distinct pathways that explain the link between relationship type and health outcomes may, therefore, not be universal. the role that technology plays in facilitating and shaping social relationships has been steadily increasing. technologies, such as emailing, texting and social media, are being used to a greater extent to connect with others and seem to be fundamentally changing how we interact. consistent with this notion, in a u.s. sample of young adults, -in- individuals reported that mobile devices were either greatly or moderately altering the way they were conducting interpersonal communication with their friends, and a vast majority of the sample reported almost constantly having their devices with them (pettegrew and day, ) . further, some evidence suggests that younger individuals may prefer to use technology-mediated communication over in-person social interactions (chung, ; pinchot et al., ) . although studies examining shifts in the ways in which individuals prefer to communicate have been conducted in predominantly younger adult populations, evidence suggests that older generations are increasingly engaging with these technologies as well. survey research conducted in the united states has shown that the rates of smartphone, internet and social media adoption steadily increased in older adult populations between and (duggan et al., ; pew research center, ) . the pew research center ( ) reported that around -in- adults aged and older had a smartphone in , which is more than double that of older adults who reported owning a smartphone in . in a qualitative study of older adults in the toronto (canada) locality of east york, a majority of participants owned a smartphone, and over half reported engaging with digital media to connect with friends and family. further, once older adults began using digital media, it became a part of their routine to promote pre-existing relationships, foster companionship, and receive social support (quan-haase et al., ) . overall, technology-mediated communication is not only being used by younger generations, but also being adopted by older generations as well. as the impact of offline social relationships on health-related outcomes in later life may vary depending on multiple factors (i.e., relationships source, type of resource, etc.), it is also essential to understand how these shifts in means of communication may influence health and quality of life as individuals age. research examining social technology in older adult populations is still in its infancy, with scarce research examining its impact on health-related outcomes (antonucci et al., ) . further, evidence regarding the effects of social technology use are mixed, with some studies showing health benefits (chopik, ; dodge et al., ; myhre et al., ; quinn, ) whereas other studies show costs (frein et al., ; meshi et al., ; soares and storms, ) . as several intervention studies have focused on social technology and cognition, we highlight cognition as our illustrative health example in the subsequent sections to discuss the distinct bodies of research that have found cognitive benefits and cognitive costs of engaging with social technology. offline social relationships and interactions have been consistently linked to better cognitive functioning (e.g., cacioppo and cacioppo, ; seeman et al., ; , however, less is known regarding whether social resources facilitated through technology confer the same benefits. some evidence suggests that social technologies may provide a unique resource for older adults to connect with others and remain socially active and cognitively stimulated. although research is limited, some intervention research has indicated that engaging with social technology may be associated with improvements in cognitive functioning (dodge et al., ; myhre et al., ; quinn, ) . for example, in a -week randomized control trial examining social media use and executive functioning, social media novice older adults received instructional sessions about social media use (i.e., setting up accounts, privacy, etiquette, posting, etc.) and were compared with a wait-list control group (quinn, ) . the results revealed that instruction in social media use was associated with improvements in inhibitory control (i.e., ability to ignore irrelevant information) after the -week period and -months later (quinn, ) . in another intervention study examining the cognitive effects of learning how to use facebook, older adults received week of instructional classes on how to use facebook and were instructed to subsequently post/comment daily for weeks (myhre et al., ) . results revealed that older adults who learned how to use facebook showed significant improvements in updating, a component of executive functioning, compared with wait-list controls and those who were trained to use a private blog as an online diary (myhre et al., ) . finally, in a -week randomized controlled trial, older adults received daily min face-to-face online communication, relative to the control group that received a weekly telephone interview. results demonstrated that cognitively-intact older adults who received the intervention showed improvements in semantic fluency immediately after the intervention and improvements in phonemic fluency at an -week follow-up assessment, relative to the control group (dodge et al., ) . these intervention studies indicate that learning how to use social media or engaging in frequent online communication in later life may help to improve some domains of cognitive functioning, such as executive functioning. that is, it may be that engaging in social media is cognitively stimulating in and of itself. it may also be that social media and online communication bolsters social stimulation, which has been linked to better cognitive outcomes. indeed, prior cross-sectional research in a nationally representative sample of american older adults has shown that the use of social technologies in later life was associated with better psychological and physical health outcomes, and these associations were mediated by lower levels of loneliness (chopik, ) . in the same cohort of u.s. older adults, internet use has been linked to lower levels of depressive symptoms in older adults (cotten et al., ) . of note, an australian study of older adults' internet use hints at the complicated associations between socioemotional outcomes and technology use. in this study, although time spent on the internet was associated with more social loneliness, using the internet as a communication tool was associated with less social loneliness (sum et al., ) . additionally, in the same study, internet use to identify new social ties was associated with higher levels of family loneliness, highlighting the complexities of researching social technology and the implications of how individuals use these tools (sum et al., ) . although some intervention research suggests there are cognitive benefits to social technology use in older adulthood, other evidence suggests that there may also be negative consequences for cognitive health. for example, in a cross-sectional study of college-aged adults, individuals who were classified as high facebook users (engaging with facebook more than h per day) scored worse on a memory recall task compared with individuals classified as low facebook users (frein et al., ) . in an experimental study, college-aged adults were assigned to either passively view a series of paintings, take photographs of the paintings, or use snapchat (a photo-sharing based social media platform) to document their experience of the paintings. individuals who used snapchat during the experiment had lower recall for the visual details of the paintings than those who simply observed or used a camera to take pictures (experiment ; soares and storm, ) . in another experimental study, college-aged adults were instructed to place their silenced smartphones either in another room, their pocket/bag, or on the desk where subsequent tests of cognitive capacity (working memory, fluid intelligence) were administered. the more salient the individual's smartphone (i.e., the closer it was), the more their cognitive capacity was impaired (ward et al., ) . further, in another experiment, these same researchers report that whether the phone was silenced or completely powered down did not alter this effect (ward et al., ) . much less observational or experimental research has examined the links between social technology and cognition in older adulthood. however, a daily diary study of u.s. adults aged to , found that on days when social media use was high, individuals also reported more memory failures that same day and the subsequent day. these findings were not moderated by age, which suggests that social media use was associated with more memory failures regardless of the age of the user . the negative consequences of engaging with social technologies for cognitive functioning may operate through attentional and/ or cognitive offloading pathways. that is, individuals who are using social technologies may have reduced attentional capacity for other stimuli in their environment (soares and storm, ) . individuals may also use these technologies to offload information onto external memory sources (risko and gilbert, ) such that individuals are relying more on technology to store information that was once previously remembered (i.e., phone numbers, birthdays, etc.). finally, some evidence also suggests that the use of these tools may alter how we process and store information. for instance, in a series of experiments, individuals who believed they would have access to saved information for a recall task tended to have greater memory for where to find the information needed (i.e., the saved folder names) than for the content of the information itself (sparrow et al., ) . overall, some evidence suggests that engaging with social technology, such as social media or smartphones in general, can impair cognitive functioning, at least in younger adulthood. less is known regarding whether these same consequences extend into older adulthood, as prior intervention research has found beneficial effects. an important consideration regarding these mixed findings is how older adults are engaging with social technology in intervention studies. specifically, older adults who are novices (i.e., little to no previous experience) are recruited and subsequently instructed to actively use social media over an extended period of time (myhre et al., ; quinn, ) . prior research has suggested that more active use of social media (i.e., direct messaging, commenting, etc.) is associated with more beneficial outcomes, whereas passive use (i.e., lurking, mostly browsing, etc.) is associated with more detrimental outcomes, at least in regards to socioemotional health (escobar-viera et al., ; thorisdottir et al., ) . when measuring the ways in which older adults engage with social technologies such as social media, it is important to note that older adults tend to use these resources more passively in everyday life to keep in touch with family and close friends. for example, older adults tend to engage in more family activities, such as viewing relatives' photos (mcandrew and jeong, ) , and view these activities as an effective tool for keeping up with the lives of family and friends (i.e., social surveillance; jung et al., ) rather than as a platform to post photos and status updates. in a qualitative study, older adults who used social media tended to report being "lurkers" to keep watch over what their friends and family members posted online (yuan et al., ) . older adults report privacy concerns as a major issue when using these technologies (jung et al., ; xie et al., ) , which may impact how actively they use social media. in addition, the costs and/or benefits of social technology use for cognition may be domain-specific, which could help to explain some contrasting findings. for example, prior intervention research has shown stronger positive associations between social technology and executive functioning (e.g., dodge et al., ; myhre et al., ; quinn, ) , whereas other research has shown costs for memory functioning (e.g., frein et al., ; soares and storm, ) . in summary, evidence regarding whether the use of social technology affects health outcomes in later life is mixed. further investigation is necessary to understand the potential impact of online social interactions for health and quality of life in older adulthood. in particular, future research should first investigate when, why and how older adults engage with these technologies as their preferred means of communication. in line with the social convoy model, personal and situational characteristics of the individual are likely to influence what means of communication are most likely to be used. additionally, an individual's goals and motivation for contact, such as future time perspective, influence the preferred means of communication as may be predicted by socioemotional selectivity theory while the savi model would argue that the goal of regulating emotions and avoiding conflict might predict one means of contact (e.g., distal versus proximal, virtual versus in-person). future research is necessary to understand not only the implications of social technology on health and quality of life in older adulthood, but also how age-related changes in social relations and socioemotional goals may impact the selection and use of these same technologies. how an individual uses social technology may, in turn, have implications for health and quality of life. in line with this notion, whether an older adult uses technology actively versus passively or to facilitate pre-existing offline relationships versus develop new social connections appears to influence the effects of using social technology. another important consideration is that these technologies have only recently become more prevalent in older adult populations, and therefore, current research can only examine short-term implications of social technology use in later life. it is necessary to recognize and understand the long-term implications of use. for instance, it is important to disentangle the effects of growing up technologically embedded on younger generations' socioemotional and cognitive outcomes over the lifespan as well as long-term use of social technologies in older adults after adoption. further, it is important to understand the historical and contextual contexts that may further influence these associations, such as the greater prevalence of using social technology to interact with friends and family in daily life among younger generations. historical events, such as the experience of a pandemic that encourages physical distancing and self-isolation (e.g., covid- pandemic), may shift the relative importance of online social interactions. during such periods, online social interactions may thus have a more prominent role in health and quality of life as they become one of the limited ways in which individuals are allowed to interact and communicate with others. additionally, technology is rapidly changing as researchers try to understand the implications of these tools and therefore, the effects of these technologies for health may also change in tandem. technologies such as virtual and augmented reality technologies are becoming commercially available and these tools may have implications for health as well. for instance, in a recent study in which adults and older played an exergame (i.e., physical activity using video games) in an immersive virtual environment (ive) over the course of -weeks, the ive group showed better executive functioning compared with the control group (i.e., non-immersive game) (huang, ) . thus, it is essential to continually assess whether changes in these technologies influence their effects on health and quality of life. finally, future research should clarify the potential domain-specific pathways that may explain the mixed findings regarding the costs or benefits of social technology in later life. it may be that gains are seen in one domain (i.e., executive functioning) but costs are seen in another (i.e., memory). the literature reviewed above reveals the powerful influences social relations can have on the physical, mental, and cognitive health of older adults. our increasing understanding of the complexities and nuances of social relations and their health impacts have important implications for multiple aspects of clinical practice. these specific insights may be harnessed to improve the clinical assessment and treatment of older adults. with regard to clinical assessment, the growing literature on social relations highlights the value of considering not only individual factors (e.g., age, educational attainment, comorbid health conditions), but also contextual factors, including characteristics of the social network(s) in which an individual is embedded, when assessing risk of mental and cognitive disorders. collecting more detailed information on the structure, function and the quality of an individual's social network can improve clinicians' understanding of risk and resilience. for example, characterizing objective social isolation without also querying the subjective experience of loneliness could result in an over-or under-identification of risk. similarly, cataloging an individual's social ties without also assessing the frequency and quality of interactions is likely to yield an incomplete picture of social resources that can be considered as promising intervention targets. thus, a comprehensive assessment of contextual factors can improve the development of clinical recommendations and treatment planning. with regard to clinical intervention, a more detailed understanding of links between social relations and health can help to reveal the "active ingredients" of social relations, allowing for more targeted interventions. for example, a recent longitudinal study that considered multiple structural aspects of social relations as predictors of cognitive aging found that contact frequency, but not social network size, was associated with slower declines in episodic memory (zahodne et al., a,b,c) . findings such as these may be used to guide the development of interventions by suggesting that increasing the frequency of interaction with existing social network members may be more effective than introducing new network members, especially if contact with those new network members will be limited. similarly, seminal studies on older adults' physical and mental health (antonucci, ) and more recent studies on cognitive aging have drawn attention to the unique value of diverse social networks containing not only close family members but also more peripheral family members and friends (see review ; fingerman, ; zahodne et al., a,b,c; ying et al., in press) . as another example, a more nuanced understanding of the costs and benefits of social strain within particularly salient relationships (e.g., the spousal relationship; birditt and antonucci, ) may help clinicians working with individuals and couples modify behaviors and/or interpretations to optimize the emotional and instrumental support derived from a key relationship. additionally, understanding the unique pathways in which different social relationships benefit health may help to clarify intervention targets. for instance, an understanding that friends may promote health through increased shared activities may inform future interventions to bolster friendships through activity/shared interest groups (i.e., art, bird watching, etc.). in line with a changing technological landscape, rapidly evolving research on the mode(s) by which individuals interact with social network members is also highly relevant to the design and implementation of interventions targeting social relations. the benefits of social interaction may differ when it occurs in-person, over the phone, or online. in particular, the role that newer social technologies (e.g., texting, video chats, social media) can play in shaping health outcomes is an active area of research. for example, research on younger adults suggests that active social media use (e.g., posting, commenting) is associated with better mental health, whereas passive social media use (e.g., scrolling, lurking) is associated with worse mental health (escobar-viera et al., ) . if findings such as these are extended to older adults, then interventions involving social media should focus on promoting active use rather than just getting older adults online. importantly, reducing the digital divide is necessary to ensure that efficacious interventions involving social technologies are also effective and that all older adults who would benefit from online social interaction have access. indeed, a recent systematic review concluded that various technologies have the potential to reduce social isolation in older adults, but more systematic trials are needed (khosravi et al., ) . in conclusion, the examination of social relations and health has made significant advances from early, small, qualitative studies to large quantitative studies. social relations encompass a complex and dynamic set of characteristics that may have distinct effects on health and quality of life in older adulthood. informed by the social convoy model, identifying the specific aspects of social relations (i.e., structure, function, quality) as well as detailing personal and situational characteristics (i.e., age, race, ethnicity, gender, etc.) may help to clarify how social relations specifically influence the individual. further, taking a life course perspective, it is important to understand the role of age-related gains and losses that may influence changes in social relationships in later life. socioemotional selectivity theory highlights the importance of motivational goals on social partner selection such that perceptions of time left may influence changes in social network size and composition. the strength and vulnerability integration model further exemplifies these points by highlighting that age-related vulnerabilities may impact social partner selection as well as how older adults cope with potential social stressors (i.e., avoidance or disengagement from negative social interactions). an understanding of the who, what, why and how of social relations helps to clarify the potential protective and/or harmful effects of each dimension of social relations on later life outcomes. specific social resources (i.e., social network size vs. loneliness), relationship types (i.e., friends vs. family), and means of communication (i.e., online vs. offline) may uniquely inform future clinical research, and these specific insights into social relations may be harnessed to improve the clinical assessment and treatment of older adults. methodological advances in measurement have made it possible to identify these social relations-health associations from the cellular to 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crear-perry, joia; maybank, aletha; keeys, mia; mitchell, nia; godbolt, dawn title: moving towards anti-racist praxis in medicine date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: w u rcnv nan moving towards anti-racist praxis in medicine "there must exist a paradigm, a practical model for social change that includes an understanding of ways to transform consciousness that are linked to efforts to transform structures." bell hooks, killing rage: ending racism the devastating effects of police brutality, maternal mortality, and covid- all have one commonality: they render disproportionate, deadly impact on marginalised and minoritised communities in the usa. after worldwide anti-racism protests in response to the murders of ahmaud arbery, george floyd, and breonna taylor, among others, several predominantly white health organisations denounced racism-specifically structural racism-and unprecedentedly declared "black lives matter". however, these declarations will require long-term commitments to equity and antiracism, specifically anti-black racism, within their organisations and within the health system and society at large. as ibram x kendi has written, "one either believes problems are rooted in groups of people, as a racist, or locates the roots of problems in power and policies, as an anti-racist". being anti-racist necessitates that institutions challenge structural racism and other intersecting oppressive systems-eg, ableism, classism, ethnocentrism, homophobia, sexism, transphobiaby shifting power-eg, funding and other critical resources, policies, processes, leadership, culture-so that marginalised and minoritised peoples can live healthily and thrive. structural racism-how societies foster racial discrimination through mutually reinforcing systems including the health-care system-violates the human rights of minoritised people. and structural racism is associated with adverse health outcomes-eg, poor health-care quality and access, increased risk of preterm birth and low birthweight, increased risk of cancer-and perpe tuates health inequities through mechanisms including racial segregation-ie, residential, school, workforce-immigration policy, and discriminatory incarceration. , practical steps to incorporate an antiracist lens are needed to remedy structural racism in medicine. for instance, the recognition of racism, not race, as a root cause or driver of health inequities and the establishment of systems that collect and disaggregate health outcome data by race and ethnicity as well as how racism may be operating (eg, discrimination, not meeting required standards of care) can be used as the basis for community-engaged quality improvement in health-care settings. , moreover, hardeman and colleagues recommend adopting universal single-payer health care, diversifying the health-care workforce, implementing medical training and competency that includes not only an awareness of racism but also how to address it, establishing performance standards related to structural racism and equity for health-care systems, and advocating for patients unjustly impacted by health inequities, even victims of police brutality. applying an anti-racist lens is not only a moral imperative in health care, it is also an efficient, equitable strategy. advances in digital health are increasingly shaping clinical practice in the usa and elsewhere and will continue to do so. it is negligent to produce inequitable health outcomes, even inadvertently so, including within algorithmic-based medical innovations, such as artificial intelligence, digital health, precision medicine, wellness genomics, and other innovations that are intended to empower individuals for better health. each is a doubleedged instrument if not forged in anti-racism. medical innovation offers great potential for refining clinical decision making to move towards health equity. yet algorithmic bias in medical innovation can be deadly, as shown, for example, where biased algorithms were used to allocate patients into "high risk care management" programmes, but instead systematically discriminated lev radin/pacific press/lightrocket/getty images against and endangered thousands of patients in the usa. medical innovations produced without an anti-racist, structural justice lens are harmful. medical innovations as equity instruments need to be designed by a meaningfully diverse cadre of engineers, social scientists, community and patient advocates, and healthcare providers. designers must test their algorithms in health-care settings that serve different patient populations-eg, younger, white, relatively healthier patients, and predominantly minoritised communities. as such innovation develops and increases its reach within health care by function and intentional design, so too must anti-racism in causal algorithmic pathways to achieve equity in effect. medical innovation must be an unbiased estimator that ever aspires toward equitable outcomes, albeit that unbiased innovation does not eviscerate bias. health system data need to be collected and used with an "algorithmic scrutiny", ensuring equity as a built-in process outcome in medical innovation tools. it is important that physicians who use innovations, and the designers who make them, are confident in their abilities to address legacies of structural racism within the clinical setting as it bears on health outcomes. this is arguably a non-negotiable skill and should be a tenet of st-century medicine. the usa is shifting demographically, epidemiologically, and in terms of opportunities to which some are exposed and others are not. projections are that the nation is approaching a shortage of health professionals, particularly among minoritised physicians, for whom the trajectory into medicine is often rife with barriers. health care in the usa is becoming more expensive to manage as use of clinical services increases. research shows that about - % of health outcomes are determined by social, structural, and root cause factors outside of clinical settings. in the spirit of bell hooks, there must be a paradigm shift such that health-care providers are trained to legitimate and incorporate anti-racist models into their practice which recognise these structural determinants of health. this level of consciousness-raising must start no later than premedical education, continuing throughout ongoing licensure, accountability, and accreditation processes. , a priority for medical education must be building an anti-racist, structural competency skill set. this involves training at the interdisciplinary nexus of medicine and the disciplines that highlight how deeply entrenched social dynamics of power, opportunity, and wellness are delineated along racial lines. anti-racist, structural competency training needs to start from pre-medicine pathways and will be essential for reimagining justice in the medical workforce pipeline. undergraduate students who are trained in anti-racist, structural competency have increased capacities for understanding root structural causes of disease. it is not enough for burgeoning clinicians to know the body, inside and out. they must also know the historical body of work about enduring medical practices based on exploitation and/or exclusion and long-standing medical policies that render certain populations sicker than others; such knowledge informs their structural competency skills development. for the same reason, new and established physicians must undergo consistent, continuing medical education that includes anti-racist, structural competency training. such level training makes for better doctors who are well prepared to address the needs of a changing nation and a changing world. this is what medical education justice in practice should look like. an anti-racist, structural justice approach is the crucial narrative frame that health-care practitioners need so that they can dismantle, reimagine, and redesign health care in a changing society. unequivocally, health is a right and anti-racism is its right-bearer. we declare no competing interests. the views expressed in this comment are those of the authors and do not necessarily represent the policy of the american medical association. killing rage: ending racism stolen breaths how to be an antiracist structural racism and health inequalities in the usa: evidence and interventions structural racism and health inequities race isn't a risk factor in maternal health on racism: a new standard for publishing on racial health inequities why does the shift from "personalized medicine" to "precision health" and "wellness genomics" matter? dissecting racial bias in an algorithm used to manage the health of populations race after technology: abolitionist tools for the new jim code artificial intelligence in health care: the hope, the hype, the promise, the peril can ai help reduce disparities in general medicine and mental health care? new findings confirm predictions on physician shortage physicians of color are far too rare: study highlights one potential reason national health expenditures highlights county health rankings: relationships between determinant factors and health outcomes structural racism and supporting black lives-the role of health professionals developing and evaluating an innovative structural competency curriculum for pre-health students responding to the covid- key: cord- -ivj imsk authors: patel, vikram title: empowering global mental health in the time of covid date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: ivj imsk nan i could hardly have imagined that mental health would have become such a commonly sought after topic in a world gripped by the fear of a marauding virus. never before have i seen so many webinars, so many pundits, and so many listeners on this topic. but then, we live in times where so much of what we took for granted has been thrown under the bus. who could have imagined even just a few months ago that much of the world would be looking down the barrel of an economic recession unlike any witnessed in our lifetime? but let me be clear about one thing: mental health has become a key concern globally not because of any direct impact of the virus, but as a consequence of the reaction of the media and governments to the epidemic. just the word 'pandemic' and the dramatic way it was announced by the who after weeks of the epidemic unfolding around the world was a hairraising moment. then, there was the apocalyptic messaging by modellers about the millions of dead bodies that would be littering our cities and by the media on the risk the disease posed-for example failing to communicate that the median age of death was in the mid- s; emerging data demonstrating the vast number of asymptomatic individuals suggests the overall mortality rate is well below %, falling to nearly zero in young people. the ghoulish reporting of cases, without any nuancing about what those numbers actually mean, served to confirm in people's minds that the virus was inexorably sweeping the world. the final nail in the coffin were the unprecedented national lockdowns, nowhere as brutal, unplanned and sweeping as the one in india, announced with just four hours' notice late in the evening, with a scope and stringency that has never been seen in history. in this context, unless you are an epidemiologist who is well-informed to correctly interpret the numbers and read between the lines, the wide-spread reactions of panic and fear are totally understandable. indeed, if one considers the constant uncertainty about when, if ever, life will return to a semblance of what we used to experience, the torrent of mixed messages about the science (real or fake) around the virus, and the complete lack of consensus on what the post-lockdown scenario for the containment of the virus might look like, i think it might even be somewhat unexpected for an individual to report being in great mental health in these times! it is not at all surprising that experiences of anxiety, fearfulness, sleep problems, irritability and feelings of hopelessness have become widespread. they are mostly rational responses of our minds to the extraordinary realities that we are facing. that said, if the curve of the severity of mental health symptoms (apologies to those who are fed up of seeing the word 'curve') has shifted to the right, i.e. towards greater severity, one will also be seeing a rising incidence of clinically significant mental health problems and suicide, as was observed in a previous coronavirus epidemic in hong kong (cheung, chau, & yip, ) . furthermore, thanks to lockdowns and the pivoting of health care services to this one virus, there is emerging evidence that routine mental health care has been seriously disrupted affecting not just incident illness episodes but also the continuing care of preexisting mental health problems. certainly, a rise in the burden of clinically significant mental health problems is what we should expect as the impact of the economic recession, the widening of inequalities in countries, the continuing uncertainties about future waves of the epidemic and the physical distancing policies begin to bite deeper into our mental health. this would not be surprising, given the strong association between unemployment, acute poverty and indebtedness with poor mental health (lund et al., ) . "deaths of despair" have been documented as the cause for the increased mortality and reduction in life expectancy in working-age americans following the economic recession in (case & deaton, ) . tracing the source of these deaths ultimately to a deeply unfair economic system, the authors point out that these deaths were not so much due to material hardship but because of loss of hope due to the lack of employment and rising inequality. suicide and substance use related mortality accounted for most of these deaths. many low and middle income countries share the ills of us society, from its profound inequality to its weak social security net and fragmented health care systems; in addition, these countries are also home to the largest number of poor people in the world, already enfeebled by hunger and myriad diseases of poverty. this toxic combination of absolute poverty with rising levels of inequality is a recipe for a similar surge of depths of despair in the region. mental health care systems in most countries will be illequipped to deal with this surge, not only because of the paucity of skilled providers, but also because of the narrow biomedical models which dominate mental health care. while there has been a flourishing of initiatives to address the rising tide of mental health problems, most notably through telemedicine platforms, these suffer from the same barriers that have so limited the coverage of mental health care in the past: most rely on specialist providers who are very scarce in number. this is compounded by yet another barrier: digital literacy and adequate internet connectivity still remains a distant goal for large swathes of the world's people, particularly amongst the poor and rural populations. still, one welcome aspect of this development is the recognition of the possibility of remote delivery and the value of psychological therapies, often ignored in mental health care and, at best, playing a poor cousin to medication options. at the same time, low-resource settings have been a laboratory for some of the most transformative innovations to improve access to evidence based psychological therapies in psychiatry with a flurry of randomized controlled trials for depression, psychoses and harmful drinking reframing the way we can enhance the coverage of these interventions. this critically important clinical and implementation science is now influencing global policies and, incredibly, also the way mental health care is organized in rich countries which enjoy so much more mental health resources. the impressive body of evidence generated by global mental health researchers has generated a range of innovative strategies aimed at addressing the structural barriers to the scaling up of psychosocial therapies, notably the demonstration that pared down 'elements' of complex psychological treatments packages can be just as effective as standardized treatment protocols (for e.g. behavioural activation for depression, compared with cognitive behaviour treatments); that providers can be trained to learn a library of such 'elements' targeting specific types of mental health experiences (for example, mood problems, anxiety problems, trauma related problems) and to use simple decision making algorithms to 'match' patients' problems with specific treatments elements; that one does not require a formal diagnosis to trigger care, greatly simplifying the dissemination of effective treatments; that these pared down treatments elements and trans-diagnostic protocols can be effectively delivered by non-specialist "therapists", such as community health workers; that these delivery models are highly acceptable to consumers; show recovery rates comparable to specialist care models, and economic analyses show they are excellent value for money (kohrt et al., ; singla et al., ) . more recent innovations seeking to scale up these approaches demonstrate the acceptability and effectiveness of digital training in the delivery j o u r n a l p r e -p r o o f of psychological treatments and of peer supervision for quality assurance (muke et al., ; singla et al., ) . this range of innovations, when combined and scaled up, can transform access to one of the most effective interventions in medicine. this is exactly the goal of the empower program, an initiative of harvard medical school (https://globalhealth.harvard.edu/empower-building-mental-health-workforce) which is seeking to scale up evidence based psychological therapies, with an initial implementation focus on communities in the usa and india. over the coming years, we intend to build on the ongoing work of the essence program, a nimh funded research hub, led by sangath in partnership with the government of madhya pradesh, to digitize the curriculum of a brief behavioural activation treatment for depression (patel et al., ) , its competency assessments and the supervision and quality assurance protocols. ultimately, this platform will offer a career path which enables front-line providers an opportunity to achieve the status of an expert, motivating them and ensuring sustainability of the most expensive mental health professional resource. future enhancements include evaluating the effectiveness of the scaling up on population mental health and harnessing big data opportunities to develop prediction models to refine treatment element selection algorithms to optimize patient outcomes. the use of digital platforms for building the workforce is not only aligned with the use of tele-medicine but also with the urgent need for digital approaches for training and supervision in the light of physical distancing policies. but, of course, implementers will need significant resources to realize these kinds of ambitious projects and here we need to anticipate the biggest threat to mental health consequent to covid : the pushing back, once again, of mental health from the global health agenda. i recall this happening way back in the late s when it appeared that mental health would finally be recognized as a priority by the world's leading development agencies only for it to be left off the table by the millenium development goals of . fifteen years later, mental health found its rightful place in the sustainable development goals and i could begin to sense its inclusion in the priorities of funders who had previously given it a pass. and now we are in the first half of and all funding and health care action has entirely pivoted towards one disease-covid . already some of the funding i had come close to securing for empower has been stalled. and some of it may never be realized. it is deeply worrying that despite the strong mental health concerns in the light of the pandemic, there seems to be no meaningful role played by mental health professionals in guiding public policies on the epidemic. once again, mental health risks are being shoved back into the shadows. this is a timely moment for diverse stakeholders concerned with mental health, from psychiatric associations and global mental health practitioners to civil society advocates, to unite with one message, that the pandemic and its socio-economic consequences will have profound effects on population mental health and that some of the financial resources being pumped into the covid response must be allocated to 'build back better' mental health care systems in all countries. j o u r n a l p r e -p r o o f deaths of despair and the future of capitalism a revisit on older adults suicides and severe acute respiratory syndrome (sars) epidemic in hong kong the role of communities in mental health care in low-and middle-income countries: a meta-review of components and competencies social determinants of mental disorders and the sustainable development goals: a systematic review of reviews acceptability and feasibility of digital technology for training community health workers to deliver brief psychological treatment for depression in rural india the healthy activity program (hap), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in india: a randomised controlled trial psychological treatments for the world: lessons from low-and middle-income countries improving the scalability of psychological treatments in developing countries: an evaluation of peer-led therapy quality assessment in goa, india key: cord- - qc b a authors: zachariah, rony; dar berger, selma; thekkur, pruthu; khogali, mohammed; davtyan, karapet; kumar, ajay m. v.; satyanarayana, srinath; moses, francis; aslanyan, garry; aseffa, abraham; harries, anthony d.; reeder, john c. title: investing in operational research capacity building for front-line health workers strengthens countries’ resilience to tackling the covid- pandemic date: - - journal: trop med infect dis doi: . /tropicalmed sha: doc_id: cord_uid: qc b a ( ) introduction. the structured operational research and training initiative (sort it) supports countries to build operational research capacity for improving public health. we assessed whether health workers trained through sort it were ( ) contributing to the covid- pandemic response and if so, ( ) map where and how they were applying their sort it skills. ( ) methods. an online questionnaire survey of sort it alumni trained between and . ( ) results. of sort it alumni from countries, ( %) responded to the survey and were contributing to the covid- response in countries. of those contributing, ( %) were applying their sort it skills to tackle the pandemic in countries and six continents including africa, asia, europe, south pacific and north/south america. skills were applied to all the pillars of the emergency response with the highest proportions of alumni applying their skills in data generation/analysis/reporting ( %), situation analysis ( %) and surveillance ( %). skills were also being used to mitigate the health system effects of covid- on other diseases ( %) and in conducting research ( %). ( ) conclusion. investing in people and in research training ahead of public health emergencies generates downstream dividends by strengthening health system resilience for tackling pandemics. it also strengthens human resources for health and the integration of research within health systems. "the operational research training i received from tdr and its partners has been invaluable as it has enabled me to transfer the skills i acquired while conducting research on ebola to my current work on covid- "-dr james squire, ministry of health, sierra leone. these words coming from a front-line doctor who led the / ebola outbreak response at its epicenter in kailahun district in sierra leone merit reflection. dr squire is now leading the ministry of health's efforts to enhance surveillance systems that generate real-time, high-quality and disaggregated data for tackling coronavirus disease . encouragingly, he is applying the research skills he gained through the structured operational research and training initiative (sort it) to his current work on covid- , but how exactly are these skills being applied? such information would help inform the wider gains of investing in research training. sort it is a global partnership-based initiative led by tdr, the special programme for research and training in tropical diseases, and implemented with various partners including ministries of health, non-governmental organizations (ngos) and academic institutions [ ] . it supports countries to build operational research capacity for strengthening health care delivery systems, improving programme performance and promoting public health [ , ] . the model is unique in that it targets front-line health workers and other programme staff, embraces "on the job" learning and simultaneously combines research training with research implementation [ ] . in line with a who call that "all nations should be producers and consumers of research and research capacity be strengthened close to the supply of and demand for health services" [ ] , sort it has trained participants from countries [ ] . with % of research studies influencing policy and practice, sort it examines what works or does not work in real-world settings and introduces solutions to improve health care [ ] . in the light of the covid- pandemic, the link between this training programme and its role in strengthening health system resilience to respond to pandemics merits examination. we therefore assessed ( ) whether sort it alumni are contributing to the covid- pandemic response and if so, ( ) map where and how they are applying their sort it skills. we carried out a semi-structured questionnaire-based survey on all sort it alumni trained from the start of the sort it programme (in ) until december . e-mails of alumni were sourced from a sort it web-based alumni network and a training database. between march and april , each alumnus received a surveymonkey link (surveymonkey.co.uk) to access the questionnaire. the questionnaire was pre-tested and included information on demographics, whether the person was currently involved with the covid- response and if so, whether he/she was applying the skills gained from the sort it training to the pandemic response. if the response to the latter was "yes", the person was asked to specify the area(s) where the skills were being applied and provide some illustrative information. up to two reminders were sent if responses were not received within days. where e-mails were invalid, social media links (facebook messenger, skype and whats app) were used to update contact details and send reminders. the sort it programme covered various aspects of the research cycle such as research prioritization, formulation of the research question, study protocol writing, efficient data capture and analysis, manuscript writing and knowledge management [ ] . sort it also has an in-built system to gather information for improving the quality and performance of the training programme [ ] . survey responders were all adults, participation was voluntary, data were anonymized, there were no personal identifiers and no sensitive personal questions were included that could risk psychological or social harm. this was thus considered a minimal risk study and the ethics advisory group of the international union against tuberculosis and lung disease, paris, france (which oversees ethics reviews for the sort it global partnership), determined that ethics clearance was not required for this study. the survey data was exported to microsoft excel and used for data analysis. the survey covered sort it courses with alumni from countries. a total of ( %) alumni (female = %) responded to the survey ( figure ). of those who responded, from countries were actively involved in the covid- response and ( %) from countries were applying their skills acquired from sort it courses to tackle the pandemic ( figure ). the top five low-and middle income-countries (lmic) where alumni were applying their skills included india ( ), myanmar ( ), zimbabwe ( ), kenya ( ), pakistan ( ) and china ( ) . sort it alumni were also using their acquired skills in high-income countries (hic) including australia, belgium, canada, italy, japan, usa, and the united kingdom ( figure ). in total, alumni from countries responded, in countries they were involved in the covid- response and in countries they were applying their skills gained through sort it. table shows various areas of the covid- emergency response where sort it alumni were applying their skills with some illustrative quotes. skills were being applied in all the pillars of the outbreak response, namely: situation analysis, surveillance, emergency preparedness, case management and data generation and reporting. the three areas with the highest proportion of alumni applying their skills were data generation, analysis and reporting ( %), situation analysis ( %) and surveillance ( %). alumni were also applying their skills in mitigating the health system effects of covid- on diseases such as tuberculosis, hiv and non-communicable diseases ( %) and in conducting covid- related research ( %). in total, alumni from countries responded, in countries they were involved in the covid- response and in countries they were applying their skills gained through sort it. i was able to use routine programme data to highlight significant declines in uptake of routine antenatal services and specific measures are being taken to address this in the community and at health facilities-sierra leonei was able to instruct health staff in the endocrine and diabetic clinics on infection, prevention and control measures and re-arranged scheduling to reduce health worker exposure to covid- -sri lanka others ( ) i am better at thinking more logically which is useful in all that i do-united kingdomi was able to organize courses, seminars and meetings with health authorities and to prepare flow charts for patient care-honduras tb: tuberculosis; hiv/aids: human immune deficiency virus/acquired immune deficiency syndrome; ncds: non-communicable diseases. many participants reported using several skills, and hence numbers and percentages are more than and % respectively. this is one of the first studies showing that sort it provides skillsets and core competencies that can be used transversally in building health system resilience at the time of a pandemic. encouragingly, about seven in every ten individuals involved with covid- reported applying their sort it acquired skills in countries, including both lmics and hics. these findings show that sort it has equipped front-line health workers not only with research skills, but also with a skill-set needed to respond to the unprecedented covid- pandemic [ ] . this proves the down-stream benefits of investing in operational research capacity building. the wide geographic coverage with no dichotomy between lmics and hics shows that such skills are universally applicable and likely to enhance global solidarity in tackling future outbreaks and pandemics. there might have been a perception by some donors that investing in research capacity building is a luxury that is divorced from public health action. much funding for research training also lies with academic institutions and is not accessible to implementers from disease control programmes [ , , ] . it is time for a volte-face. the strengths of this study are that sort it alumni in countries were contacted and specific efforts were made to validate invalid e-mails, thereby limiting non-responders. as the sort it programme has a robust built-in monitoring and evaluation system, we were able to make use of this existing system to gather both quantitative and qualitative information. study limitations include a response rate of %, which under the circumstances is still acceptable to good, the self-reported nature of the response, the potential social desirability bias and, considering the continued expansion of the covid- pandemic, possible underestimation in our figures. there are a few other salient observations. first, skills are being applied beyond research to all the vital pillars of the outbreak response. while sort it teaches multiple and practical skills for activities such as generating and utilizing data, conducting operational research and using evidence to influence policy and/or practice, several transversal skills are acquired at the same time [ ] . for example, skills are developed in fostering stakeholder engagement, performing situation analysis in programme settings, prioritizing health issues, ensuring quality-assured data capture and analysis, critically reviewing the scientific literature, scientific writing to the standards of a medical journal and managing knowledge. it is therefore not surprising that those who were trained through the sort it programme acquired a "tool-kit" of skills that can then be applied to several areas of the outbreak response. second, the three areas where acquired skills were particularly used were data generation, situation analysis and setting up surveillance systems. the generation of high quality, timely and disaggregated data is essential for ensuring that countries tackling covid- become "data rich, information rich and action rich"-a fundamental goal of the sort it programme [ ] . conducting a sound situation analysis and setting up robust surveillance systems are crucial in any outbreak: these help to feel and monitor the pulse of an outbreak and prevent responders from thinking and acting blindly. third, with the lock-down and restricted movements imposed by covid- , individuals with chronic diseases such as tuberculosis, hiv/aids and non-communicable diseases will understandably face hurdles in accessing diagnostic and treatment facilities and adhering to follow-up schedules [ ] . it is encouraging that sort it alumni were using their skills in offsetting these negative health system effects. finally, following the / ebola outbreak, who spearheaded global efforts to avert epidemics by making research and development (r&d) "outbreak-ready" [ ] . while this will accelerate r&d on vaccines, drugs, and diagnostics, finding out "how to deliver" these innovations in an equitable manner is imperative [ ] . sort it could play an important role in such operational research. in conclusion, the results of this study demonstrate the value of investing in people and in research training ahead of public health emergencies. clearly, building upstream operational research capacity has generated downstream dividends in strengthening health system resilience for tackling pandemics. in addition, it strengthens human resources for health (hrh) and the integration of research within health systems. in summary, it allows the health system to have the right people in the right place at the right time. author contributions: all authors were involved with the conception and design, r.z., s.d.b., p.t., m.k. were involved with data collection, analysis and interpretation while k.d., a.m.v.k., s.s., f.m., g.a., a.a., a.d.h. and j.c.r. were involved with interpretation. r.z. wrote the first draft of the manuscript, which was revised by all and all authors have read and agreed to the published version of the manuscript. funding: this research received no specific external funding. acknowledgments: tdr and partners can conduct their work thanks to the commitment and support from a variety of funders. these include our long-term core contributors from national governments and international institutions, as well as designated funding for specific projects within our current priorities. a full list of tdr donors is available on our website at: https://www.who.int/tdr/about/funding/en/. we are grateful to all these donors and particularly those who have supported research training activities, which allow health workers to save lives on the frontlines of the covid- public health emergency. we are also grateful to all the sort it alumni who have responded to this survey despite their tight schedules and for their invaluable work in tackling covid- . the structured operational research and training initiative for public health programmes building the capacity of public health programmes to become data rich, information rich and action rich publishing operational research from 'real life' programme data: a better form of accountability research for universal health coverage; world health organization tdr. sort it coverage and outputs does research through structured operational research and training (sort it) courses impact policy and practice? public health action covid- reveals weak health systems by design: why we must re-make global health in this historic moment how to get research into practice: first get practice into research avoidable waste in the production and reporting of research evidence tuberculosis and hiv responses threatened by covid- we have no conflict of interest to declare. de-identified study data are available on reasonable request from the corresponding author (zachariahr@who.int). a justification for its further use should be provided. the designations employed and the presentation of material in this information product do 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suggestion that who or this article endorse any specific organisation or products. the use of the who logo is not permitted. key: cord- -t zbfvlo authors: salvage, jane; white, jill title: our future is global: nursing leadership and global health date: - - journal: revista latino-americana de enfermagem doi: . / - . . sha: doc_id: cord_uid: t zbfvlo global health matters to every nurse everywhere. in this article we outline why. we highlight some important health issues confronting the world today; explore how these issues are being tackled; and consider the implications for nursing. we describe how nurses are making a difference in the challenging contexts, range and complexity of nursing work round the globe, and we conclude with a call to action. nurses can influence, and become, policy-makers and politicians, and explain to them why the sustainable development goals cannot be reached without strengthening nursing. in this international year of the nurse and midwife, the window of opportunity is open, but it will not stay open for long. nurses and midwives globally and locally must be ready to jump through it. we ask you to join hands, and join us. as health professionals committed to our local community and country, it is tempting to look no further than our own backyard, where there is always so much about which we care deeply. yet this solely local focus is not only ostrich-like, but also dangerous: global health is inseparable from local and national health concerns. infectious diseases, for example, do not recognise borders, and a mingling of germs and genes results in communicable diseases with the potential for rapid global spread. compare the speed with which the coronavirus and covid- infections spread worldwide, to the four years it took the medieval plague to cross europe. the concept of "global health" did not really exist even years ago. now it embraces a complex concept that engages with all countries and indeed with the health of the planet itself ( ) . a growing number of governments and organizations are adopting it as a key policy theme. in thinking about nursing today and tomorrow, we must all look beyond our backyards, and understand how what happens in distant places affects the health and health care of our communities, our loved ones, and ourselves -just as what happens in our backyard affects people we will never meet. covid- has surely heightened awareness of this. "think globally, act locally!", as the environmental slogan says. thinking globally is not an academic exercise but a way of seeing that enriches perspectives, increases knowledge, and makes nurses more motivated and effective as leaders, practitioners, managers, teachers, researchers, policy-makers and activists. it helps us to understand how our work contributes to outcomes not only in health sectors, but also in policy, education, economic relations, and environmental activism. nurses have a professional obligation to understand the world in its broader context and base decision-making on an expanded understanding of ourselves, our patients, and our circumstances. "it begins with understanding the policies and politics of globalization, the growing interdependence of the world's people, [which] means that national policy and action are increasingly shaped by international forces along with other aspects of our lives" ( ) . we increasingly rely on the same groups of workers and technologies and face the same environmental and epidemiological threats. moreover, the policies that most affect health are not always health policies ( ) . other policies have enormous impact on health determinants and solutions, so cross-sectoral collaboration on global health is critical. we live in challenging times, for the health of the planet, nations and communities. the challenges have major implications for nursing as a global profession of some million, from halting pandemics to reducing mother and child deaths, tackling and mitigating the effects of climate change, and caring for older people. inequalities between groups of people, and within and between countries and regions, are key to understanding these challenges. there is a mass of evidence of the interaction between health and wealth at all levels, whether individual, family, community or country. nurses know that their patients' ways of life and the conditions in which they live and work strongly influence their health and longevity. this challenges us to complement biomedical models of health care with social models, and focus much more on prevention and public health. since the s there has been a growing understanding of the interaction between health and poverty, and the need for cooperation and collaboration on a global scale to combat its consequences for health and for economies. this has stimulated many organizations to play a larger role in global health. eradicating poverty in all its forms and dimensions is the greatest global challenge, says the united nations: many nurses make naive assumptions about health and healthcare and do not view these issues through a sociopolitical lens ( ) . yet we need to understand some history and politics if we want to be leaders of change, rather than its servants. policy and politics determines not only the health of populations but also nursing itself -past, present and future. it profoundly shapes the practice and workplaces of nurses at local, regional, national and international levels. nurses who wish to influence and lead policy, rather than be bystanders, should understand not only the content related to a health issue, but also the policy process, the context, and the stakeholders and their interests ( ) . www.eerp.usp.br/rlae rev. latino-am. enfermagem ; :e . the largest proportion of the health workforce globally by a large margin, nurses are often the only health care provider available. we are key to ensuring that all people and communities receive the health services they need without financial hardship. nurses occupy a special position as the interface between the health system and the community; we see, hear and know, as end users of health policies, how policy affects people and their communities. you might think that knowledge would be welcomed with open arms by policy-makers, yet it has been very difficult for nurses at all levels to make an impact on policy, for a variety of reasons ( ) . while nurses are acknowledged as key policy implementers -the pairs of hands, they are rarely central to health and social policy developmentat the top table ( ) . nurses engaged in high-level global health work apply their nursing lens to issues that others may not notice. they bring information from the field to high-level meetings, explain the complexities of implementing programmes, and interpret the science or recommendations from these meetings back to the field in a way that may be translated into action. australian nurse amanda mcclelland, for example, was the senior officer in the emergency health unit of the international federation of red cross and red crescent societies. "i added a social mobilisation and community aspect to global strategy discussions", she said ( ) . "how am i going to explain this to the volunteers and how will they explain it to the community? that's great, but the community would never accept it. that's great, but we won't be able to implement the programme in that way. we're going to need to consider weather/culture/religious factors when rolling this out." nurses worldwide have become increasingly knowledgeable, skilled and well educated, like mcclelland, but this has not been matched with a significant growth in their influence and status. the reinventing itself as a champion of nursing and midwifery, the chief nurse and head nurses in the six who regional offices used to have much larger teams and budgets. all have declined in scope and influence, attributable partly to cuts in who budgets, but also to long-standing reluctance to recognise the value of the nursing contribution. less assertive" ( ) . speaking with one voice and in a language that appeals to policy-makers has not been one of nursing's successes ( ) . nor has the ability to persuade policymakers to take effective action on nursing issues. nursing history in many countries and at regional and international levels is strewn with evidence-based policy reviews and reports making excellent recommendations that go largely unheeded. compounded by structural inequalities related to gender and social class, nurses' attempts to push for reform have not gained enough traction, and change has not happened fast enough or far enough. policy leadership is required in the everyday workings of national and local government and health systems. a key nursing competency, it is rarely acknowledged or formally developed; most nurses learn it, if at all, by bitter experience. the need for nurses to develop these competencies has long been highlighted ( ) , but not consistently developed across the global nursing community. white advocates "policy leadership and role modelling" by nurse leaders, who need the right professional, political and policy skills to operate effectively in tough arenas. whether they work in government, management, education, advanced practice, research or development, they need to know how to maximize their distinctive contribution to shaping, influencing and implementing policy decisions ( ) . this requires nurses to grasp white's concept of a "new pattern of knowing called socio-political knowing" ( ) and, as salvage has long advocated, to become policy activists who are politically savvy ( ) . www.eerp.usp.br/rlae salvage j, white j. reports and recommendations on nursing that fail to have traction, policies that ignore or undermine nursing, and nurses' absence from policymaking -this gloomy pattern is starting to change for the better. more nurses are becoming policy entrepreneurs: leaders who position themselves to influence policy; who bring together problems, policies and politics into a novel amalgam -new policy; and who soften up the system by presenting participants in the network (visible and invisible) with alternative representations of their realities. this leads to the opening of a window of opportunity, as described by kingdon -the potential for a truly new policy perspective ( ) . that window is opening wider as demand grows worldwide for solutions to acute problems including current and future health worker shortages, and the rising need for expert care of older people, alongside huge public interest in nursing. there is greater global awareness of the importance of investment in health as a public good, and of nurses' massive actual and potential contribution to improving health, creating gender equality and strengthening economies. meanwhile more nurses are finding the courage to become "silence breakers" and join the worldwide wave of protests against violence, sexual harassment and other abusive behaviour against women ( ) . the major shifts necessary to transform nursing will not be effected through a continuing series of shortterm, piecemeal policy initiatives, however good each may be. deep-rooted, sustainable change will depend on reaching honest, shared understanding of the barriers to change and the structural inequalities and issues that maintain them, and on tackling the root causes and underlying drivers. these big issues are not solved by tips on how to exploit the status quo, and patience is unlikely to be the answer either. this is the moment for nurses to shift the paradigm, to be taken seriously together and individually, when the old certainties and ways are being shaken to the core. nursing organizations, as well as trying to gain influence at the top tables, are making alliances with social movements and considering radical alternatives. all this could lead us to a new story of health and healthcare ( ) . nurses, as leading actors in this story, will be at the heart of sustainable health systems that meet individual and population needs, are fit for the present, and innovative and adaptable for the future. rooted in reality, yet reaching for the stars, nurses work to shape sustainable, high quality, effective and affordable services fit for the future, and responsive to the challenges of turbulent times. they focus on where the needs are greatest and where there is most potential to gain health and reduce inequalities. they take their understanding and experience as hands-on practitioners into all their subsequent roles, as clinicians, managers, teachers, researchers, scholars, policy-makers and leaders. at all levels, from ward to board to international organizations, they inspire and lead. we began by arguing that 'doing global health' means thinking globally and acting locally: adopting a mindset that seeks to understand the structural and political conditions that sustain armed conflict, ( ) ). "thinking globally and acting locally" is old wisdom, but never more needed of nurses and nursing than now. www.eerp.usp.br/rlae rev. latino-am. enfermagem ; :e . we have also argued that the challenges facing the planet and our own communities have major implications for nursing and nurses, and shared our hope that nurses can influence (and become) politicians and policymakers, showing them that the sdgs cannot be reached without strengthening nursing. in this year of the nurse and midwife, the window of opportunity is open, but it will not stay open for long. nurses and midwives globally and locally must be ready to jump through it. will you join hands, and join us? box -how nurses can engage with global health begin at home -think globally and act locally. cultivate a worldview; be sensitive to the cultural aspects of policy and practice. commit to learning more about the global health agenda, above all the sdgs. know where regional and international organizations and your national and local government stand on key international health and nursing matters, and lobby them. get involved in global health issues, and team up with like-minded groups and people at home and internationally. through your professional association, trade union, workplace or community, help colleagues in and from other countries -and learn from them -as they work to strengthen nursing and health. advocate, initiate, and document nursing's role in policy. join others in ensuring that national and local structures and roles are in place so that nurses' voices are heard in policy and practice. ensure that nursing leaders -and new nursing graduates -know about policy and politics, how to analyze the environment, how to develop strategy, and how to work together. undertake and disseminate research to build evidence of nursing effectiveness. share your ideas and achievements through discussions, publications, conferences, social media and the internet. global health and global nursing; emerging definitions and directions international health and nursing policy and politics today: a snapshot triple impact: how developing nursing will improve health, promote gender equality and support economic growth united nations. transforming our world: the agenda for sustainable development nurse practitioners: working for change in primary health care nursing. london: king's fund centre through a socio-political lens: the relationship of practice, education, research and policy to social justice people's health movement reforming the health sector in developing countries: the central role of policy analysis emergencies only. crow's nest: allen & unwin so many voices, so little voice. can nurse stages of nursing's political development: where we've been and where we ought to go nurses: a voice to lead the politics of nursing. london: heinemann agendas, alternatives, and public policies. nd ed breaking the silence: a new story of nursing key: cord- -ntmsyum authors: donaldson, cam; mitton, craig title: health economics and emergence from covid- lockdown: the great big marginal analysis date: - - journal: health economics, policy, and law doi: . /s sha: doc_id: cord_uid: ntmsyum despite denials of politicians and other advisors, trade-offs have already been apparent in many policy decisions addressing the coronavirus disease pandemic and its social and economic consequences. here, we illustrate why it is important, from a wellbeing perspective, to recognise such trade-offs, and provide a framework, based on the economic concept of ‘marginal analysis’, for doing so. we illustrate its potential through consideration of optimising the balance between reducing the reproductive rate (r) of the virus and further opening of the economy. the framework accommodates both perspectives in the health-vs-economy debate whereby, depending on where we are within the marginal analysis framework, either health issues are allowed to dominate or, below some threshold of r and/or background level of infection, health and economic considerations can be traded off against each other. given the inevitability of such trade-offs, the framework exposes crucial questions to be addressed, such as: the critical value of r and/or background infection, above which health considerations predominate, and which may vary from jurisdiction to jurisdiction; and the value of lives forgone resulting from the small increases in r and/or background infection levels that may have to be tolerated as the economy is gradually opened. trade-offs, trade-offs everywhere, but not a health economist in sight. it could be argued that this has been one of the puzzling things of the coronavirus disease (covid- ) pandemic, given that resource scarcity and trade-offs are the very lifeblood of economics. perhaps (health) economics is not 'scientific' enough. perhaps laying bare the trade-offs being made would not be seen as helpful to politicians who, naturally, do not like to recognise that they exist. however, trade-offs have been palpable at all levels of decision making. the economic stimuli of governments across the globe have traded-off the future against the present and sectors of the economy with each other. health and social care have been traded off against each other, with investments in large (often unused) health care capacity at the expense of services and equipment for people in care homes. within health care, non-covid-related care has been suspended to accommodate needs arising from the pandemic; initially for sound clinical reasons relating to do-no-harm, but less so now. from the very start, in many countries, shortages in testing and personal protective equipment were apparent, with meaningless large numbers thrown out in attempts to appease the public (e.g. the ' , -per-day' in the uk) and little recognition given to a more-systematic approach to what might be needed by different groups, from which priorities for access, based on health gain for resources expended, could be established. even economists would recognise that there is a level of pandemic where trade-offs do not matter, or, at least, are so obvious that little analysis is required. this is also because, beyond a particular level of r (the reproduction rate for the virus) and background prevalence and incidence, the economy and health considerations go hand-in-hand. particularly, at certain levels of disease, r must be controlled. also, economists can contribute to the more 'science-like' modelling work of various international research groups; and, likely, have been doing so. but surely, health economics has more to offer as a way of thinking and, thus, in contributing to honest debate about emerging tradeoffs once r is controlled and the curve flattened. the trade-offs emerging now are those around lockdown. no more so than in the us, where federal and state governments have often been at loggerheads over the health and economic trade-offs of releasing (and imposing) lockdown, as well as in the now-numerous other locations, internationally, where local lockdowns have been imposed. with public health leaders having done their best to flatten the curve in many jurisdictions and cases increasing in others, we are now in a new phase where a broader set of questions, and disciplines like health economics, are particularly relevant. this requires a framework which brings considerations of health and the economy together and to which (economic) modelling can contribute. it is necessary because, as indicated, the trade-offs are happening now, but without systematic analysis or public debate. health economics can facilitate this using a theoretical and well-established framework known as 'marginal analysis'. an economic approach to priority setting simply has to adhere to two key economic concepts; 'opportunity cost' and 'the margin'. opportunity cost refers to having to make choices within the constraint of limited resources; certain opportunities will be taken up while others must be forgone. the benefits associated with forgone opportunities are opportunity costs (karlsberg schaffer et al., ) . thus, when applying such a framework within publicly funded health and social care, we would normally state that a consequence of opportunity cost, and in order to spend a limited budget to maximum effect, we need to know the costs and benefits from various health and care activities (donaldson et al., ) . marginal analysis refers to the fact that assessment of costs and benefits is best addressed 'at the margin'. the focus is on the benefit gained from the next unit of resources, or that lost from having one unit less. imagine that resources are so scarce that we have to choose between elective heart and hip surgery programmesperhaps not such an unrealistic prospect, even in parts of the us and in other well-funded health care systems, going forward in the short-to-medium term. the question is not one of whether to resource one whole programme and none of the other. rather, it is one of balance between the two. if marginal benefit (mb) per $/£ spent from, say, an elective heart operation programme is greater than that for an elective hip replacement, then, all else equal, resources should be taken from hips and given to hearts (olsen and donaldson, ) . on the basic economic principle of 'diminishing marginal benefit', whereby physicians prioritise those with most to gain, mbs from hearts will begin to fall as the programme is expanded and those for hips rise, as lessbeneficial care is withdrawn, until the two come into alignment, all else equal. such reallocation would stop, therefore, at a point of balance, where the mb (relative to marginal cost (mc)) for hearts and hips are equalised. based on such thinking, marginal analysis frameworks have been developed and applied in several hundred health organisations internationally (mitton and donaldson, ; peacock et al., ; tsourapas and frew, ) . indeed, we would also contend that such frameworks, and the way of thinking they embody, could have been used in earlier stages of the pandemic and even in preparation for it. unsurprisingly, a 'great big marginal analysis', of the sort currently required and which we now outline, has never, to our knowledge, been undertaken. often, the thought process behind marginal analysis is better described via a sequence of conceptual diagrams, which we now do in the context of emerging from lockdownsee figure . the assumptions, to illustrate, are that we are now in a zone where the background level of infection is still significant but in which r is less than . we are, of course, aware that r differs by subgroups, across time and by location, but this does not deflect from the substance of the argument that trade-offs with the economy, whether at local, regional or national levels, can be made; and, indeed, are being made. this has often been denied by politicians in many countries, but is now, further into the pandemic and the associated adverse consequences of lockdown, more-openly discussed. the 'benefits' being traded-off refer to some abstract notion of aggregate community well-being. such benefits can arise from individual and private sector activity, but, in the current context, is heavily overlain and intertwined with public 'bads' and negative externalities (in the form of communicable disease), and, conversely, with improvements delivered by public goods and positive externalities (e.g. future protection). therefore, given that only collective (i.e. not individual) actions can deliver such public goods and internalise such externalities, the framework is one proposed for use and adaption by government and other public agencies. for purposes of illustration, we are saying that such community benefit can be monetised and so presented on the same scale (or axis) as costs (figure a ). diagrams to the left in figure illustrate mcs and benefits of reducing r from to whilst those to the right illustrate the same for opening the economy. in the latter, we include all sectors; public, private and civil society. first, we invoke the above-mentioned notion of diminishing mb, whereby the mbs of reducing the r-value from is positive but gradually reduces. let us say that in the range of r = . - . , mb reduces only very gradually ( b), after which, due to it being less critical, a sudden drop off in mb occurs before it continues on a more-regular downward slope ( c). accordingly, and to be clear, as we reduce r, the total benefits are greater and greater, but the increases, in terms of the marginal social value of the corresponding health gains, are lesser and lesser. hence, the downward sloping mb line for r and, correspondingly, for 'opening the economy' ( c and d). of course, we would recognise that, in the latter case, people may debate which sectors, or even which parts of sectors, are more or less valuable, even at the margin. however, even within sectors, we assume that the most-needed parts will be opened first, or, of course, never close. to aid presentation, assume the mc of reducing r or economic expansion are constant and equal ( e). the question then becomes, given, on any particular day, a particular starting point for each of r and the economy, where do we go from here ( f). from g, it can be seen that the gap between mb and mc (or the mb/mc ratio) at the chosen starting point for the economy is greater than at the starting point for r. thus, the economy can expand and r can be allowed to drift upwards as we trade-off the gains from the former against the losses (which there will inevitably be) from the latter. opening of the economy can continue until the mb/ mc ratios are equalised. the final diagram ( h) shows that, when a consequence of any economic expansion is for r to fall back into . - . range, the marginal gains from any such expansion will be too small to justify going past a certain point, beyond which the gains from focussing on r far outweigh those of the economy. it is important to reiterate that we are not claiming that the lines in figure can be measured accurately. they are used to represent an important debate currently ensuing throughout the world as well as a thought process to aid its resolution. it is a thought process which accounts for the two main perspectives in ongoing 'health-vs-the-economy' debates. depending on where we are within the marginal analysis framework, either health issues dominate, only because they go hand-in-hand with the economy, or, below some threshold of r and/or background level of infection, health and economic considerations can be, and we would contend are, traded off against each other. moving forward with such a framework has two main implications. the first is that criteria are required to reflect what we mean by 'benefit' (peacock et al., ) . in the current context, this must be done with respect to reducing r, extent of infection and opening of economies. many governments have defined sets of criteria for each, but have not connected them in one framework. second, and relatedly, nor have many governments openly admitted the need for trade-offs, not only within which lives may be lost but also tolerated. indeed, it might be argued that deliberately not recognising trade-offs then allows avoidance of such uncomfortable truths. even when below some critical threshold (like . in our example), a small increase in r will result in more infections and, as just alluded to, risk to life. note current international debates on ' m vs m' on social distancing. is there an amount of economic expansion which might provide benefits to the population so great by which an upward drift in r, with its consequent risks, would be permitted? such issues require debate and evidence on at least two key things: the critical range within which concern for r and background infection levels take over any concern even for incremental opening of the economy, a range which may, of course, vary across jurisdictions; and more explicit use of values of health and life which already exist and are used in public policy (viscusi and aldy, ; donaldson et al., ; baker et al., ) . the latter are based on asking representative samples of the population about the value they place on small changes in risk (chilton et al., ) . their use, ultimately, means facing up to the question of the value to be placed on life and health vs opening the economy at the margin, accepting that that value may change according to whether we are above or below a critical value of r. in our view, the trade-offs referred to in this paper are inevitable and, for purposes of optimising overall human welfare, are better recognised, analysed and publicly debated. willingness to pay for health. encyclopedia of beyond covid- : how the dismal science can prepare us for the future cost effectiveness analysis in health care: contraindications the social value of a qaly: raising the bar or barring the raise? opportunity costs and local health service spending decisions: a qualitative study from wales priority setting toolkit: a guide to the use of economics in healthcare decision making helicopters, hearts and hips: using willingness to pay to set priorities for public sector health care programmes using economics for pragmatic and ethical priority setting: two checklists for doctors and managers priority setting in health care using multi-attribute utility theory and programme budgeting and marginal analysis (pbma) evaluating 'success' in programme budgeting and marginal analysis: a literature review the value of a statistical life: a critical review of market estimates throughout the world health economics and emergence from covid- lockdown: the great big marginal analysis key: cord- - gq wy authors: tracy, derek k.; tarn, mark; eldridge, rod; cooke, joanne; calder, james d.f.; greenberg, neil title: what should be done to support the mental health of healthcare staff treating covid- patients? date: - - journal: the british journal of psychiatry : the journal of mental science doi: . /bjp. . sha: doc_id: cord_uid: gq wy there is an urgent need to provide evidence-based well-being and mental health support for front-line clinical staff managing the covid- pandemic who are at risk of moral injury and mental illness. we describe the evidence base for a tiered model of care, and practical steps on its implementation. the covid- pandemic is unprecedented in modern times. healthcare systems are struggling to manage clinical need, with concerns about the availability of adequate personal protective equipment (ppe) and covid- testing. staff, particularly those from black, asian and minority ethnic (bame) groups, will worry about their own greater risk of infection and that they might subsequently infect their loved ones. furthermore, healthcare staff are affected by wider societal and economic tensions, including the impacts of social distancing and fewer social resources. this complex combination of pressures risks adverse mental health outcomes. an emerging issue is how best to protect the well-being and mental health of staff contending with these circumstances. many are working outside of their area of expertise and training, with rapidly changing clinical guidelines, limited equipment and structural resources; greater numbers of significantly unwell patients, many of whom will die; and less-than-ideal staffing levels, in part owing to staff sickness and quarantining. the particular challenges of working in unprecedented ways that test their professional codes of conduct may, if sustained for a long enough period, induce what is known as 'moral injury'. all employers have a legal duty of care and moral obligation to provide appropriate support to their employees, including mitigating and responding to work-related traumatic incidents. not paying due attention to this risks poor performance, mental ill health and staff absences. however, we have precedent and learning from both past pandemics and dealing with the impact of traumatic events. this editorial describes the evidence base for optimising staff support and how healthcare systems such as the national health service (nhs) can practically implement such approaches. from 'moral injury' to evidence-based interventions the construct of 'moral injury', which is derived from military settings, is described when facing overwhelming demands for which one feels unprepared and where actions or inactions challenge an ethical code. it is associated with negative emotions such as shame or guilt, and can lead to the development of mental illnesses such as depression and post-traumatic stress disorder (ptsd). whether moral injury is of itself a subset of ptsd remains an area of debate and contention. however, conversely, most individuals exposed to trauma do not have long-term sequelae, even without support, and post-traumatic growth may occur in such settings. treating covid- is a risk for moral injury. professional codes teach us to provide care only when we feel adequately trained, experienced and equipped to do so. many healthcare staff may perceive that they are insufficiently prepared or equipped for their work during the pandemic. whether individuals experience injury or growth will be influenced by support received during and after this time. although not directly causative of moral injury, institutions and services have key roles in mitigating against the likelihood of adverse outcomes. however, to date there have been no explicit evidence-based practical plans published to guide staff and service providers. a tiered approach to anticipating, recognising and managing moral injury or mental illness should be taken. notably, emerging research shows that moral injury leads to mental disorders, including ptsd and depression as well as suicidality, in a minority. this approach includes: primary preventioninterventions to avert mental illness onset; secondary preventionfocusing on those with early signs of possible illness; and tertiary preventiontreatment of those with such problems. staff must be inducted with clear realistic information, frank briefings and reflection on the risks and challenges they face, includ- ing moral injury. this should subsequently be repeated at appropriate points such as the beginning or end of shifts. obvious covid- examples include wearing ppe for protracted periods, having many unwell patients in very acute settings and high mortality rates. a range of factors increase the risk for subsequent development of ptsd, including pre-disaster life events and mental illness, direct traumatic exposure, having tasks outside one's normal remit, and perceived risk to self or those with whom one lives. initial selfassessment declaration forms can help individuals consider these challenges and associated stresses and confirm their perceived suitability for such work. however, there is little evidence that prescreening staff has any predictive value. accurate, up-to-date information on available resourcesfrom self-help techniques, through to digital apps and online resourcesshould be clearly available on trusted and easily accessible locations such as organisational websites and posters. social support within teams should be fostered, potentially assisted by 'buddying up' shift-colleagues to monitor each other's well-being. beginnings and ends of shifts provide natural opportunities for team discussions and reviews to enhance camaraderie and foster team spirit. however, there is a lack of evidence for psychological debriefing and post-incident counselling, which may actually increase harms. these are not the same as leader-led operational debriefing, an important aspect of good leadership. team managers may benefit from active listening skills and trauma awareness training on, for example, actively making contact with those who seem to be avoiding discussions or meetings or are displaying evidence of 'presenteeism'. this can cover helping staff with problem-solving and facilitating access to professional support. fast feedback and improvement cycles should be established to learn from front-line staff. the work environment should be optimised to support appropriate nutrition, rest and sleep periods. there are numerous 'well-being' initiatives, in various formats, both covid- specific and more general. some are national, for example in the uk resources collated by the covid trauma response working group (www. traumagroup.org) and the royal college of psychiatrists (https:// www.rcpsych.ac.uk/about-us/responding-to-covid- /respondingto-covid- -guidance-for-clinicians). many specific well-being offerings lack evidence with regard to preventing the development of ptsd and these should be recommended with caution. staff with pre-existing mental health conditions might experience recurrence or deterioration; others will have de novo presentations. it is reasonable to assume that anxiety, depression, adjustment disorders, ptsd and substance use disorders will be the most commonly seen. although there is no evidence to support more generalised post-incident organisational screening, experienced welfare-focused staff with training in predisposing risk factors and developing signs of mental illness can be utilised to help identify individuals appearing to be developing difficulties and to appropriately follow them up, for example at the end of a shift. outcomes here might include no further input, signposting to well-being resources, or further assessment via general practitioner, occupational health or mental health services. evidenced peer-support protocols are available to train staff to look after each other. a notable example is the trauma risk management (trim) programme first developed in the uk armed forces. this aims to reduce the stigma surrounding mental illness, teach recognition of emerging symptoms and encourage access to appropriate services and processes, especially where individuals may be reticent about speaking to their line manager. adequate support and supervision for peer-supporters is essential, as they are vulnerable to being vicariously traumatised. taking learning from the military on operational deployments, tertiary prevention needs to be nimble 'forward psychiatry', and not practice as usual. accessibility and rapidity of service are important to determine whether individuals can return to work, possibly with advice or work adjustments, or whether a more formal assessment is required. the pies modelproximity, immediacy, expectancy and simplicityis an evidence-based occupational health approach supporting individuals to continue working where they can and building self-esteem so that they can cope with distress. this encourages keeping staff close to their front line, even if on altered duties; getting help before distress escalates into a crisis; a strengthsbased positive focus 'de-medicalising' normal responses in difficult times; and keeping interventions simple. in most staff, signs of ptsd will rapidly self-resolve, and the national institute for health and care excellence (nice) recommends 'active monitoring' without instigating treatment in most cases. mental health input will need to be ready to escalate, however, including commencing medication and working with primary care, occupational health, secondary and tertiary mental health supports. longer-term follow-up needs to be considered, not least as many staff will have been temporarily deployed to new sites and teams and will be returning to services that are unaware of their difficulties and needs. finally, there is a need for collection and sharing of learning and research. in the uk, the national institute of health research (nihr) holds an accessible central resource: https://www.nihr.ac. uk/covid-studies. the challenges of covid- are substantial and the longer-term healthcare and societal outcomes yet to be determined. moral injury and the development of mental illness are very real risks for staff working in unprecedented scenarios often well outside their ordinary levels of experience and training. this editorial provides an evidence-based model of support and care for staff and managers in these environments. we recommend a tiered model of inputs: good induction; building supportive 'buddy' relationships and managerial debriefs; appropriate environmental and 'virtual' well-being supports; and provision of rapidly accessible mental health professionals able to carry out timely 'return to duty'focused assessments and brief interventions. unless services take active measures and adopt a proactive 'nip it in the bud' approach, the psychological consequences of the pandemic on healthcare staff could be dramatic. managing mental health challenges faced by healthcare workers during covid- pandemic traumatic stress within disaster-exposed occupations: overview of the literature and suggestions for the management of traumatic stress in the workplace trauma risk management (trim) in the uk armed forces frontline treatment of combat stress reaction: a -year longitudinal evaluation study national institute for health and care excellence. post-traumatic stress disorder (nice guideline ng ). nice the work was supported by the national institute for health research (nihr) health protection research unit in emergency preparedness and response at king's college london, in partnership with public health england and in collaboration with the university of east anglia and newcastle university. all authors meet all four icmje criteria for authorship and have approved the final version of this manuscript.declaration of interest n.g. runs a psychological health consultancy that provides resilience training for a wide range of organisations, including a few nhs teams. the views expressed are those of the authors and not necessarily those of the nhs, nihr, department of health and social care, or public health england.icmje forms are in the supplementary material, available online at https://doi.org/ . / bjp. . . key: cord- -d l fnb authors: farquharson, wilfred h.; thornton, carmen j. title: debate: exposing the most serious infirmity–racism’s impact on health in the era of covid‐ date: - - journal: child adolesc ment health doi: . /camh. sha: doc_id: cord_uid: d l fnb the covid‐ pandemic retells a story that other diseases like hiv, diabetes, and cancer have clearly internationally illustrated. minorities in developed countries across the globe – especially those of african, hispanic, and native american descent – suffer a greater burden of disease than whites. the evidence of the cause and effect relationship of racism on mental and minority health outcomes is staggering. racism and its influence on policy and important structural systems allow health inequities across racial and ethnic groups to persist. what’s more troubling is how systemic racism impacts children from all races and has been perpetuated across many generations dating back hundreds of years. the impact of racial oppression is seen through intergenerational trauma which impacts youth in varying ways. for this article, we offer three areas in which racism causes healthcare disparities, intergenerational trauma, social determinants, and cultural mistrust. effective policy change and a greater level of accountability must be placed on major systems including health care, to most fully counter racism’s varied role in sustaining mental health inequities. during his address to the medical committee on human rights, rev. martin luther king, jr. included in his speech the quote, 'of all the forms of inequality, injustice in healthcare is the most shocking and inhumane' (zabel, ) . while racial segregation in public institutions has ended and voting rights extended to communities of color, many societal inequities in place during the us civil rights movement continue to thrive. more than fifty years after dr. king's address grave disparities in healthcare outcomes among racial and ethnic populations remain. however, differences in health outcomes among racial and ethnic groups are not a problem exclusive to the united states. the covid- pandemic retells a story that other diseases like hiv, diabetes, and cancer have clearly illustrated internationally. minorities in developed countries across the globeespecially those of african, latin, and native american descentsuffer a greater burden of disease than whites. the evidence of the cause and effect relationship of racism on mental and minority health outcomes is staggering. racism and its influence on policy and important structural systems allow health inequities across racial and ethnic groups to persist (gee & ford, ) . the greatest question and our most important work surrounds how can we terminate systemic racism and offer healthy and safe environments where all children can thrive. for this article, we offer three areas in which racism deepens challenges and drives a broader need to address health disparities among communities of color during the era of covid- . intergenerational trauma defines how the experience of a traumatic event that began years before the current generation is transferred and impacts how individuals within a family or community understand, cope with, and heal from trauma (acamh). racism's impact on mental health is obvious. a family's or community's exposure to racism over multiple generations has had lasting and reprehensible effects on many socioeconomic levels. the transference of trauma across generations is also known to result in increased emotional dysregulation in children (powers et al., ) . the long-term psychological impact and trauma of covid- has yet to be observed, but the social isolation, fear, and grief resulting from the pandemic will likely impact the children. specifically children who live in poverty that may only be afforded adequate social engagement through school and other community programs that have been closed due to the virus. some children may have experienced higher levels of abuse as lengthy stays at home prolongs time spent with a caregiver who may also abuse or neglect children. the disenfranchisement of people of color from a global perspective has roots dating back to slavery as can be evidenced by where some descendants of slaves currently live. one of the greatest social determinants impacting health is housing. living in a safe environment with access to healthy options for nutrition and good air and water quality is not guaranteed for many living below the poverty line. government officials took serious measures to stop the spread of covid- , and the term 'social distancing' became the slogan that required people to both stay at home and remain ft. or more away from one another. in cities like london, new york, new orleans, and chicago, that order was impractical for most. it is no secret that those cities are largely inhabited by people of color for a number of historical reasons such as affordability and employment. social distancing and the ability to work from home are not an option for many. in the uk, it was noted that nearly / of the black africans and ¼ of black caribbean people were considered key workers or essential (siddique, ) . this would reflect the fact that % of patients in icu in england, wales, and northern ireland were members of the bame (black, asian, and minority ethnic) community and hospital deaths for blacks in the uk were twice as high compared to their white counterparts. vast covid- -related concerns have impacted children and adolescents of color at greater levels including, one or both parents/caregivers becoming ill or dying, one or both parents/caregivers becoming unemployed due to layoffs, no or limited home access to wifi or electronic devices to consult for medical care or continue school work, and isolation along with losing access to support services or safe places as home may be an abusive environment. without question, socioeconomic factors caused these covd- -related disparities. however, we cannot deny nor overlook that the healthcare system is ill-advised on how to incorporate best practices in caring for people of color. suggestions and recommendations abound on the need to include the voice of communities of color in decision making when handling healthcare issues and in conducting research. further examination of social determinants highlights a healthcare system that has remained deficient in providing unbiased coverage, is shaped by barriers in provider linguistic and cultural competency, and riddled with obstacles in creating adequate access. insurance status has been identified as a significant contributor to ambulatory care for blacks (kirby et al., ) . with regard to insurance-based healthcare systems like the united states., there was a message of 'no-copay' for covid- testing, but what about people with no insurance? and what about the message that hospitals and testing sites were sanctuary sites? if the primary goal is population health and saving lives, these barriers cannot persist among a global pandemic. the idea of seeking treatment and getting tested for covid- can be frightening for many people. the current political climate in the united states has been cruel to both documented and undocumented immigrantsparticularly those from countries in the caribbean and central and south america. this undoubtedly creates a barrier to care as people have been unable to get insurance and are less likely to seek medical care despite their conditions out of fear of being detained or deported by us immigration and customs enforcement (ice). when it comes to the consideration of clinical trials for a covid- vaccine, issues of cultural mistrust arise within african american communities as the us public health service syphilis study at tuskegee, gynecological experiments in slave women, and the use of henrietta lacks' hela cells are remembered (washington, ) . failure to achieve health equity across communities of color reflects the clear racial divides that run across the united states, the uk, europe, and most of the world. to most fully counter racism's varied role in sustaining health inequities, effective policy change and a greater level of accountability must be placed on major systems including health care, housing, education, employment, and criminal justice. the charge as we continue to move through the covid- pandemic and prepare for recovery is to shift the focus to population mental health, as that will be the true second wave in managing the trauma of a global pandemic. practitioners should focus on targeting the children of the most impacted communities in order to disrupt the pattern of intergenerational trauma. be prepared to address the disproportionate impact on people of color when providing treatment and aid children and their parents to regulate emotion. ensuring measures for adequate and accessible telemedicine should be considered a high priority. additionally, we must not cease efforts toward community outreach and patient care because of fear of infection. people of color with limited health literacywhich is a contributing factor to health disparitiesneed outreach to close the gap (orr et al., ) . every public official and practitioner should consider the tenets of 'herd immunity' and apply it as a means to promote mental health awareness and end racism. with a growing population of people who embrace the cultural norms of other groups and prioritize mental health treatmentchange is subsequent. should mental health professionals understand structural racism and health inequities explaining racial and ethnic disparities in health care racial/ethnic differences in medicare experiences and immunization intergenerational transmission of risk for ptsd symptoms in african american children: the roles of maternal and child emotion dysregulation. psychological trauma: theory, research, practice, and policy british bame covid- death rate 'more than twice that of whites medical apartheid the dark history of medical experimentation on black americans from colonial times to the present what happens to health care quality when the patient pays? quality and safety in health care accepted for publication the authors have declared that they have no competing or potential conflicts of interest. no ethical approval was required for this article. key: cord- - dczotbh authors: everts, jonathan title: announcing swine flu and the interpretation of pandemic anxiety date: - - journal: antipode doi: . /j. - . . .x sha: doc_id: cord_uid: dczotbh this paper discusses the ways in which novel swine‐origin influenza a (h n ) was announced and resonated with current pandemic anxieties. in particular, the us centers for disease control and prevention (cdc) are used as a lens through which recent pandemic anxieties can be analysed and understood. this entails a closer look at the securitisation of public health and the challenges and struggles this may have caused within public health agencies. in that light, cdc' formal entanglement with global health security and its announcement of the h n pandemic are interpreted, followed by an ethnographically informed focus on various people who were engaged in the h n emergency response and their practices and practical struggles in the face of pandemic anxiety. as it stands, the influenza a h n pandemic ("swine flu") is believed to have caused up to , deaths worldwide between early and august , when the world health organization (who) announced the end of the pandemic. though the pandemic of the virus has been real and caused many tragedies, observers criticised the attention it received from politicians, global health agencies and experts. critics warned especially of the potential to exploit pandemic threats for fear-mongering and profit-making (gostin ; sparke ), overshadowing at the same time other long-term global health problems, often related to social inequalities (craddock and giles-vernick ; davies ) . with hindsight, the event of swine flu appears as a small event in respect to anticipated severity and death rates. nevertheless, public health officials and experts stressed their moral obligation to abide to the "precautionary principle" to prevent as much harm as possible even if that means taking some extreme measures, spreading anxiety and playing into the hands of the pharma industry (caduff ; gallaher ; michaelis, doerr and cinatl ) . however, swine flu was a global event, not just from an epidemiological perspective. it was exceptionally widely covered by the news media, inciting a broad range of responses by state and non-state actors, occupying the attention of millions of people for a greater part of . responses included mass distribution of antiviral drugs, production and stockpiling of vaccines, mass slaughtering of pigs in egypt, quarantine for slightly feverish air passengers in china, restrictions and cancellations of flights to mexico, and asian import bans on pork products from the usa. each individual reaction contributed to swine flu as a global event of anxiety through intensifying and amplifying the sense of urgency in the face of this new infectious disease. due to the early emergence of novel h n in north america, the us centers for disease control and prevention (cdc) were at the forefront of h n emergency response. scientists working for cdc were among the first to identify the new microbe and to carry out substantial virological and epidemiological research (special issue of clinical infectious diseases january , supplement ; dawood et al ). they informed the public, politicians, who and other public health agencies worldwide. put simply, the way the world initially learned about h n was significantly shaped by cdc. from a social science perspective, its central role qualifies cdc as a powerful lens through which we can seek to understand h n 's sudden rise to prominence and the ways it was dealt with. investigating cdc's h n response may also shed light on the implications of a change in public health discourse, a change that made "emerging infectious diseases" a key concern for public health, the kernel of a new age of "pandemic anxiety" (ingram ) . for the purpose of this paper, i will employ the perspective of "anxiety as social practice" (jackson and everts ) . building upon schatzki's ( ) practice theory, the phenomenon of anxiety can be opened up to a much broader analysis since anxieties "are embodied and social, practical and practised" and like "other social practices, they are routinised, collective and conventional in character" (jackson and everts : ) . here, of particular interest is how anxieties become "institutionalised" and worked through within organisations (jackson and everts : ) . certain events engender anxieties specific to an organisation, overlapping with general concerns in respect to the event. events important to an organisation can threaten its meaning of existence, its legitimacy and its credibility. in the case of emerging diseases, pandemics pose a threat and challenge to public health agencies, creating anxieties over its reputation and expertise. although these latter anxieties are derived from pandemic anxiety, they are significant in their own right, shedding light on general anxieties pertaining to that specific organisation and its area of expertise. in the following, cdc's ways to work through the h n pandemic are first contextualised within the emerging global health security regime and second analysed from a practice-based and ethnographic perspective. research conducted within cdc in early , involving expert interviews, informal conversations and observation, provides the background for the findings presented. the aim is to use cdc as a lens through which we can, partially at least, understand the ways in which pandemic anxieties work. this entails a closer look at the securitisation of public health and the challenges and struggles this may have caused within public health agencies such as cdc. in the next section, a brief account of the securitisation of public health discourse is provided. then, cdc's formal entanglement with global health security and its announcement of the h n pandemic are presented. this is followed by shifting the perspective onto various people who were engaged in the emergency response and their practices and practical struggles in the face of pandemic anxiety. scholars from the social sciences have identified significant changes in public health discourse since the early s (collier, lakoff and rabinow ; davies ; elbe ; fidler ; king ) . the analytical kernel of this changing discourse is perhaps best captured by the term "securitisation" (fidler and gostin : ) . here, securitisation refers to the observation that much of public health discourse has become organised around concerns over security rather than, say, humanitarianism or welfare. following elbe ( : ) , we can distinguish analytically at least between four types of security relevant to the emerging "health-security nexus": national security, biosecurity, human security, and public health security. in terms of national security, king ( ; see also king b) demonstrates how the discursive production of scales allowed us american scientists, public health agencies and journalists to reframe the international problem of emerging infectious diseases as a threat to american national security. by employing scale politics, eminent scientists in the field of virology, microbiology and epidemiology were able to provide answers to uncertainties arising from globalisation. by making emerging infectious disease the key challenge, enhanced laboratory practice and disease surveillance appeared as effective and nationally manageable countermeasures against the adverse effects of globalisation. this particular discursive strategy was effectively conveyed to politicians and journalists at the conference on "emerging viruses: the evolution of viruses and viral disease", chaired by eminent virologist stephen s. morse from rockefeller university. also highly influential was the publication of the report emerging infections: microbial threats to health in the united states ( ), presenting the views of a committee convened by the national academy of science's institute of medicine in . the report became the blueprint for rapidly evolving literature and strategy plans on how to tackle the problem of emerging infectious diseases (king : - ) . public awareness was achieved through the media and journalist writers, since "the concept of emerging diseases offered journalists a powerful scalar resource for characterizing individual outbreaks as incidents of global significance" (king : ) . both scientists and journalists added bioterrorism to the problem of emerging diseases (king a (king , , emphasising once more the importance of emerging viruses to national security. from there it is only a small step to biosecurity, another security framework increasingly important to public health. for collier, lakoff and rabinow ( ) , growing concerns over bioterrorism and uncertainties in relation to new research possibilities culminating in the human genome project, provide the context of the "emerging biosecurity apparatus". the apparatus has as its main aim to "make life safe" through "attempts to monitor, regulate and/or halt the movements of various forms of life" (bingham, enticott and hinchliffe : ) . this entails a problematic justification for repressive internal politics as much as for new forms of imperial politics. as braun ( : ) argues, biosecurity is "a set of political technologies that seek to govern biological disorder in the name of a particular community, through acts that are extraterritorial" (emphasis in the original). both emphasis on national security and biosecurity are deeply entwined and brought together through the terminology of global health security. in discussing pandemic anxieties, ingram ( : - ) identifies three main facets of global health security discourse: the emergence of the global as the definitive context for infectious disease; a tendency to locate causes, origins, and responsibility elsewhere and with others; and the emergence of global health security as a guise for the consolidation of hegemonic interests. notably, global health security discourse advances at the expense of other discursive formations, in particular that of human security and humanitarianism. following lakoff ( ) , we can juxtapose global health security and humanitarian biomedicine as two competing public health regimes. "humanitarian biomedicine" refers to the ongoing effort to mitigate existing health problems prevalent especially among poorer nations. in contrast, "global health security" focuses on "emerging infectious diseases"-diseases that have not occurred yet, for which one must be prepared, and which are more relevant to richer countries. "whereas global health security develops prophylaxis against potential threats at home, humanitarian biomedicine invests resources to mitigate present suffering in other places" (lakoff : ) . similarly, davies ( ) argues: while the securitization attempt has meant that particular infectious diseases have reached the realm of high politics, a great number of communicable diseasesparticularly those that are most likely to remain in poor, low-income countries-are not receiving the same level of attention despite the fact that some of these diseases contribute to a greater number of deaths per year (davies : ). in the same vein, farmer ( : ) argued a decade earlier in respect to tuberculosis that "the degree to which this disease is seen as a threat varies with the degree to which the powerful-or, at least, the non-poor-are deemed to be 'at risk'". this particular mode of non-poor pandemic anxiety is deeply worrying in the view of critical scholars since the rich have powers to enforce various kinds of borders, through violence if necessary. as, for instance, price-smith ( : ) argues, fear and anxiety generated by infectious disease are often most visible in "vicious persecution of minorities or of other polities" and "may even lead to the oppression of the people by a governmental apparatus of coercion in order to maintain the ideology of order and the 'interests' or the state". the h n pandemic and pandemic threats such as severe acute respiratory syndrome (sars) and hpai h n (avian flu) gave evidence to the various impacts of securitisation discourse. in discussing the canadian response to sars, keil and ali claim that "racism, infection, globalized urbanization are reshuffled into a new political frame of reference" since "racism, linked specifically to infectious disease and the bodies allegedly carrying it, structures biopolitical space of the sars crisis and requires that it be understood from the point of view of affected communities: east asians and those who were identified as such" (keil and ali : ; emphasis in the original). the egyptian response to h n showed another securitisation bias towards large-scale "modern" economies. the cull affected mainly rooftop and backyard poultry but restocking was in favour of large companies . securitisation also leads to more hierarchical "chains of command" and the centralisation of decision-making, as became apparent by the uk's response to h n (chambers, barker and rouse ) . looking at public health discourse in the usa, we cannot neatly distinguish historically between a pre-securitisation phase and the current securitised one (fearnley ; french ; wald ). however, the "emerging viruses" conference and the "emerging infections" report seem to signify the beginning of an acceleration of a specific interweaving of public health and security discourse. from a cdc perspective, the tipping point was the anthrax scare that followed the / attacks. since then, cdc experienced a "culture shift", as my respondents phrased it. although us security politics were already attuned to the perceived threat of bioterrorism (king ) , anthrax gave the immediate impetus for changing the make-up of us public health organisations. and this was by no means only a discursive shift. since , cdc was gradually reformed from a scientific branch of the federal government into an intelligence service supplementing national security and defence politics. this change was achieved through a great influx of retired military personnel who began work for cdc in various divisions. some became advisor to the director, which brought further changes to the organisational and spatial structure. cdc in pre- years resembled a very large research institute or university, openly accessible to virtually everyone. however it has become more than ever a hierarchically organised agency with command structures, which resemble those of military departments; and cdc campuses are now fenced off and only accessible through security check points. within this emerging new organisational structure, two big pandemic anxieties were worked through before h n . while sars occupied cdc's attention in , it was really h n in - which had lasting effects on cdc's organisational structure and preparedness planning. from the research as much as the communications point of view, cdc looked good during h n in (see below). as an explanation for this, some of my interviewees pointed repeatedly to the response structures that were built under the impression of h n : regarding h n , the awareness was already there and somehow we could tap into it. for h n , we did a lot of pandemic influenza planning and in every [us] state we had a conference about what needs to be done. and a year later, (with h n ), we were able to turn that on. so, all the planning efforts paid off. preparedness planning also involved frequent exercises, which simulated cdc's emergency response in case of a new pandemic. when h n began, "it was just like an exercise" as one epidemiologist put it and another stated, "we all flipped into exercise mode". swine flu was treated like a possible h n pandemic. from an epidemiological and medical point of view, concerns are still in order over h n developing into an easily spreading human-to-human infection with mortality rates over %. such a devastating prospect justifies augmented surveillance of emerging viruses and provides an important context for the rapid detection of novel h n and subsequent response. however it was not only exercises that primed, cdc experts for the next pandemic. according to cdc epidemiologists, various cases of novel influenza a (h n ) were investigated in the years before the actual outbreak in . the background to this was the position statement by the council of state and territorial epidemiologists (cste) that made all novel influenza a viruses nationally reportable in (cste ) . in particular, the position statement from cste requires that "state and territorial epidemiologists in conjunction with public health laboratories will report to cdc all human infections with influenza a viruses that are different from currently circulating human influenza h and h viruses", including viruses "that are subtyped as non-human in origin and those that are unsubtypable with standard methods and reagents" (cste ) . this step was justified on two grounds. first, any novel influenza a virus could "signal the beginning of an influenza pandemic" and, in turn, "rapid detection and reporting" would "facilitate prompt detection and characterization" and "accelerate the implementation of effective public health responses". second, the usa had formally accepted the revised international health regulations (who ) in . the new regulations demand its member states to notify the who on various events detected by national surveillance systems, among them cases of "human influenza caused by a new subtype" which are deemed-among others (smallpox, polio, sars)-as "unusual or unexpected and may have serious public health impact" (who : ) . since the position statement of the cste was issued ( july ), a team of cdc epidemiologists investigated all reported cases of novel influenza a viruses in the usa. these investigations became routine. most of the time, children contracted a (h n ), suffered from flu symptoms and recovered. field investigations could confirm in most cases that children had been to a country fair or farm where they were exposed to live animals, especially pigs (cf shinde et al ) . that was also the assumption that accompanied the investigations of the very first cases, a boy and a girl aged and , respectively, of novel h n in southern california in mid april despite "rumours" within cdc about what was happening in mexico. the mexican general directorate of epidemiology (dge) reported during march to april a total of suspected influenza cases, including confirmed cases and a total of deaths. suspected and probable cases were reported from all states and from the federal district of mexico and were identified in all age groups. nevertheless, to cdc experts, the mexican events seemed to be locally isolated, possibly caused by an influenza b virus. at first sight, the cases in california had no connection to mexico and the investigating team did not fear any significant further spread. only when a case in texas was reported on april just a few days after the two cases in california did cdc epidemiologists begin to consider the likelihood of a connection to the events across the border. laboratory testing on the behalf of cdc confirmed on april the presence of the novel virus swine influenza a (h n ) (cdc a; first posted as a morbidity and mortality weekly report early release on the website on april). cdc acknowledged the "epidemiological characteristics" of novel h n and recommended monitoring of public health practices "in anticipation of a possible pandemic" (cdc a) . the connection to what was happening in mexico was officially recognised by cdc on april : "patients were infected with the same strain" (cdc b). significantly, this acknowledgement came days after director general of who, margaret chan, "declared this event a public health emergency of international concern". swine flu was by then already addressed on a global scale, following the guidelines of the recently revised international health regulations. from a cdc perspective, who did not wait for three subsequent generations of infections and thus made its announcement too early. cdc experts took another weeks of research before calling h n the "greatest pandemic threat since the emergence of influenza a (h n ) virus in " (dawood et al ). announcing swine flu met certain criteria that justified the choice of terminology. a new pathogen had been identified, its spread verified by connecting cases in different places and its origins classified as a new and as of yet unknown combination of viral genotypes that resulted from previous microbial traffic between birds, pigs and humans. however, before the actual work that led to detecting h n took place, pandemic anxiety and institutionalised heightened concerns had already worked their way through to cdc experts via global and national public health security recommendations and regulations and the announcements made by respective representatives. from this perspective, institutionalised pandemic anxiety pressed public health organisations to announce swine flu as significant global event as soon as possible. judging from the resources and work put into h n emergency response, organisations such as cdc had to play along. however, shifting the focus on the people whose work was critical in turning novel h n from an unknown viral agent into the global event of swine flu, we find a more complex and less straightforward process. in particular, the pressure on a public health agency such as cdc arises from multiple directions and dealing successfully with those pressures involves a host of creative strategies. in the following, both pressures on and strategies by cdc experts during h n will be analysed to provide a more nuanced account of the entanglement of pandemic anxieties and expert practice. the change in perspective is mirrored in a change of language. in the vein of ethnographic writing, the voices of both the author of this paper and the respondents at cdc are foregrounded, allowing for a deeper and more personal account. since recording of interviews was not possible, quotes are taken from fieldnotes and conversation protocols written down after conversations took place. accuracy was one of the terms that i heard frequently during my stay at cdc. it was specifically used in the sense of accurate data or "i need to make sure my data is accurate". as a scientific branch within the us government, to obtain, gather and provide accurate data presents a legal as much as a moral obligation for cdc. that was reflected in personal conversations i had through comments such as: "we speak with the voice of the us government. we need to make sure everything is % right"; "we are just like who or the red cross, people trust us, the cdc doesn't lie." however, frequent use of the term accuracy suggests that the term signals not only an obligation but also a key challenge. even at times with rapid data-processing technology, the process of gathering, managing and interpreting data is a time-and resource-consuming affair. hence, at first, i thought the term accuracy was being used as an indicator for the problem of lacking time and other resources. but that was only part of the explanation. the "white house theory" makes a good entrance route for clarifying the accuracy anxiety. in one group discussion, it was pointed out that "there is this theory, the white house could come in any time, asking for information, 'how bad is it'." based on this common assumption, everybody within cdc knows that information and data have to be ready at hand. this is especially the case when the emergency operations center (eoc) becomes activated as happened during h n . during emergency response, "time is compressed . . . everything is happening faster", as one of my respondents phrased it. another person i talked to, who was not a regular member of the eoc team, explained: "they don't want to be caught off guard, they want to show they take everything seriously, that they go all guns at all events." this was backed up by similar comments that stated that there was "certainly the anxiety [at the eoc] to look foolish" and that "being blamed for not doing . . . enough is probably one of the worst fears of the eoc." during the h n response, time compression became a challenge for all involved in data gathering, processing and visualization. epidemiologists were the first ones to experience exceptional pressure: "the struggle really is to stay updated. there's not any other system with this time schedule. and we get the pressure from hhs [united states department of health and human services] and washington. and especially with h n we had that." in effect, the pressure was not only to provide data as quickly as possible. it was furthermore to provide high resolution data: "it was the first time really cared in that detail, there were new demands for data on a more detailed level. you see, by and large, people are not interested in flu, it just happens, they think. and suddenly, they wanted all this detailed information." one of the most pressing needs for assessing the h n situation became acquiring data of influenza-like illnesses (ilis) throughout the united states. this, it was hoped, would yield important insights into the spread of the disease, its demographics and the localities most in need of mitigation measures. because of the federal character of the usa, ili data are gathered in aggregate numbers on the state level and shared on a weekly basis. if cdc wants more detailed information (down to the day and county level), they need to call up the states individually. thus, the emergency response team during h n had to call up all the states to get the latest data. in processing and visualising these data, a number of divisions were crucial. one of them produces maps based on those data. from my conversations with cdc cartographers it appears that during h n , requests for maps were scheduled within a -min time frame. the demand for new, timely and detailed data and the visualisation thereof thus progresses through the various branches within the organisation, making time compression an issue for hundreds of experts involved in emergency response. time compression has a bearing on people's work experience during emergency response. they need to cope with constant demands for new products, which have to be ready within minutes rather than hours. but this does not seem to be the key concern of those involved in emergency response. in the case of epidemiological maps, for instance, they were able to produce maps at very short notice within minutes thanks to thoroughly developed templates and software. the problem however lies within the time allocated for checking the data for possible flaws, "to make sure my data is accurate". working within emergency temporality, the real challenge lies in providing accurate information as fast as possible. as indicated by the above quotes about cdc's obligation, there is no allowance for communicating any faulty information. people working within cdc are well aware of the consequences that even slightly incorrect data can have. thus, within their obligation to provide information that is " percent right", cdc experts feel the need to resist all demands for timely data until they have carried out at least a few routine checks for data accuracy. this leads to elongated duration between demands for new data and their presentation. that little extra time-indicating the resistance of cdc scientists in presenting unchecked data-forms the core of a principle conflict between those who pass along the pressure for new information generated by "the white house" and the experts and scientists who provide this information. from an epidemiologist's point of view, those representing the governmental side within emergency response do not recognise the vital importance of the time lag between the demand for data and dissemination: "it feels as if they think we're withholding data or information." indeed, talking to other people at cdc, comments were made that suggested that reluctance from cdc experts in providing data as quickly as possible is frowned upon. during h n , this general suspicion was apparently augmented by a lack of reported severe cases within the usa. once the connection to h n cases in mexico became apparent, swine flu appeared as a deadly new disease. but from the epidemiologists' point of view, "as long as you don't know how many people got sick, the population denominator, you cannot say whether the mortality rate is high or not". although cdc sent an already established team to mexico that began counting cases and creating statistics, "the question from white house was, why were there virtually no reported cases in the us". according to cdc epidemiologists, hospitalisation rates in the usa were monitored closely but at no time was the threshold passed that would have led to an automated alert message. therefore, epidemiologists "felt put under microscope"; why did they not get any alerts despite all the sophisticated surveillance and report systems? did they overlook the cases? in my view, this moment represents the point when cdc scientists were at their weakest position. increasingly, their role as rightfully proclaiming scientific truths became more and more questioned. however, they were able to turn their perceived weakness into a powerful resource. since routine surveillance data appeared insufficient, money for thorough case studies research was successfully acquired. among the very first field investigations was the survey of the entire student population and faculty of the university of delaware, altogether around , people. taken together, infections were confirmed in % of the survey population, no deaths. in terms of the feared severity of the disease, the findings from this and very similar studies brought hope. if this had been a re-run of the infamous - pandemic, the delaware study would have revealed around deaths; especially since young adults were the age group hit hardest by h n . the information from this case study and others was published by the new england journal of medicine on may (dawood et al ). with hindsight, the publication of this paper at a very early stage of the pandemic was described by some of the authors as the most successful move during the unfolding pandemic, to communicate the very first findings and inform the public. as one of the authors said, they were able to "do a lot of really good work" during the beginning of h n . it seemed as if there was "no time to do it" but they "cranked the scientific work out, despite how horrible things were". only weeks after the first call informing them about the first cases in california, they had their article accepted by the new england journal of medicine. the article is mainly concerned with epidemiological core concerns (demographics, symptoms, severity, hospitalisation rates, nucleotide sequencing). though being very cautious in the interpretation of their findings, the authors state in their discussion section that to date they are not encountering a disease in the usa that would justify exaggerated concern since "most confirmed cases of s-oiv infection have been characterized by self-limited, uncomplicated febrile respiratory illness and symptoms similar to those of seasonal influenza" (dawood et al : ) . this is confirmed by comments made by others at cdc about their relief and receding worry already a few weeks after the first occurrence of swine flu, in particular after case studies showed the limited numbers of serious complications due to the novel virus. however, work for cdc epidemiologists and all other divisions involved in the response did not stop there. from then on, important decisions had to be made, including the definition of risk groups and distribution of antivirals and development of vaccine. nevertheless, the critical moment had passed; cdc experts had successfully demonstrated their ability to generate relevant knowledge and information within a very limited timeframe. nevertheless, pressure on cdc experts did not ease and arose from other directions. on may , a -year-old pregnant woman died from complications due to h n ; one of the very first deaths from swine flu in the usa. this tragic case illustrated that h n had the power to kill despite the generally mild symptoms it generated in most patients. from the news media point of view, the ability to kill young women and children made swine flu even more hideous-and more compelling. thus, another challenge to cdc arose from the way swine flu appeared in the headlines of the news media and the stance cdc was trying to convey. within cdc, risk communication has become an important area of concern since the early s. as one of the eminent cdc risk theorists stresses, we can identify certain patterns in which the "media behaves in a crisis": the media, those are only humans as everyone else. first they look at their own safety and are concerned. but once they figure out, it's not that bad for me, they begin to look for the sensation in the event. we were fortunate enough that we never had an outbreak of hemorrhagic fever (ebola) in the usa. at the same time, you notice how the media are fascinated by threats that are grotesque but distant. and it creates scares. but i know if we had an outbreak of ebola here, the whole tenor would be different. so the more distant, the more the media compounds something, the more real the threat, the more they will look for reassurance. however, the trouble with swine flu was that it was not a distant or rare and grotesque disease but it was there and widespread. thus, following the pattern identified by cdc's risk communication expert, we would expect a more responsible and reassuring media approach. but since swine flu was already pronounced to be in general mild in early may, sensationalism still became an issue for cdc scientists and communication experts. from the scientists' point of view, when in a response situation, the challenge is to strike a balance between informing the public on the one hand and to "resist the media who call all the time and ask what's new" on the other: they want quick and accurate information. but we cannot be irresponsible. we need to make sure our data is accurate, our data is valid. and then we can craft a message. and that means that even if the cnn wants to know every hour what is happening, that's too frequent, and then the information is sloppy. that would be irresponsible, especially since the health of people is at stake here. once again, the struggle seems to be over the speed of information and the accuracy of data. however, there is another aspect that becomes more prominent within cdc's engagement with the media. again from a scientist's point of view, the media appears sensationalist. although they provide the media with a lot of detailed information, what actually makes it into the news seems to be driven by sensationalism: you never really know what the press is interested in. you can give them all this information and all they would talk about is this one boy . . . who died shortly after vaccination. and of course, every single death is a tragedy but we are worried about the major changes. the media is all sensational, they have the family and the one death and that's their product and they sell it like a product. from this point of view, cdc scientists try to strike a balance between using the media as an important tool for conveying urgent information to the public but to be reassuring at the same time: "we think about it, whether something causes alarm or brings reassurance. and we try to convey reassurance. we want to bring out the scientifically most accurate data, turn it into a digestible format and reassure. the government should not be alarmist. it has to be reassurance." just as scientists are anxious to strike a balance between information and reassurance, cdc communication experts take the same approach: "we were very careful in striking the balance; we did not want people to have no concern and as well we did not want to be the cause for concern." but how can such a balance be achieved? what i deduce from my conversations with experts, the communication strategy is complex and works on many levels but one aspect came up repeatedly and is possibly the main technique harnessed for striking the balance between raising awareness and conveying reassurance: we're not just gathering data and display the data itself. we do much more than that. we put the data into context; demographics, population characteristics, infrastructure . . . c the author. antipode c antipode foundation ltd. i remember when we had this map with the deaths of children. that was not reassuring. people only see the number, and children dying. so we try and craft a language around it and to put it into context. putting data into context is an important strategy for cdc experts dealing with the media. from a communication expert's point of view, "we've done a pretty neat job [with h n ]-we had done enough in showing what it is and what it does". similarly, scientists were pleased how cdc handled the media and expressed that "the agency did a great job in controlling the media during h n ". following lakoff ( ) in his analysis of the revised international health regulations (ihr), making many different disease events reportable to who was one of the key innovations in establishing a global disease surveillance system. the new ihr was developed over concerns that nation states would try to hide outbreaks from the international public over fears they could have negative effects on trade and tourism. credibility to these concerns was lent by the way the chinese government initially handled the sars crisis. part of the new strategy epitomised by the altered ihr was to integrate the media into global public health surveillance by adding media reports as one source of relevant information over disease outbreaks to the established reporting by health authorities. but even though it seems as if global health security and news media had forged a successful alliance, my examples from cdc's struggle with the media during swine flu suggests that this alliance is contested in practice. particularly interesting is that from a cdc perspective, there is almost a race between the media and cdc of who knows first: "the media knows it at the same time as we do and we need to gear up for response as fast as we can". in order to stay ahead of the game and to have sufficient time to "gear up" before the first media calls get in, cdc experts developed other tactics of early detection that do not rely on the media: so what we do, for example, we get the data from the pharmacies about over-thecounter drugs such as tamiflu and absenteeism from school and prescriptions from doctors and the ili data. so that is real-time data and it is by place too. so say we have a huge rise in tamiflu sales and you see it on the graph, your line is going up and then you look at absenteeism, and the graph is going up as well and so on, you start to think, well, maybe something's going on here. it's not conclusive but you have some evidence that something is happening. so you go to your flu experts and tell them, there is a cluster, maybe this is a new breakout. and maybe it's not. that's what you need to find out then. . . . the aggregate tells you more than a single information. . . . you need to track the key indicators. . . . you only need four or five indicators but you'll be months ahead if something is happening. this mode of surveillance is entirely decoupled from the media and is designed to even outrun more traditional ways of detecting new diseases such as routine laboratory investigations. crucially, each data source does not tell much on its own. only "data fusion"-the aggregate information-can provide enough evidence for concern. another way of getting real-time information was installed through a -hour toll-free hotline. people can call there about anything and any topic. as one communication expert told me, "for cdc, this information is a canary in the coalmine". interestingly, concerned people who call cdc for information become themselves informants and a crucial role in cdc's early warning systems. this is also true for the cdc website and services provided through social media feeds. within cdc, a web metrics report is created daily. the report includes the most popular pages and how people did come to that site and it is understood as a part of cdc's surveillance. according to an analyst, "h n had some really interesting metrics". they had million page views in one day. the highest traffic ever seen before was half a million. from these data, growing awareness and concern could be deduced. but not only this, the analysis of traffic to the website also reveals the locations of those viewing the website: "you can show where people were concerned. [during h n ] we had this huge pipeline to our website from china and japan so we knew these are the next affected regions. same thing with h n when we got a lot of traffic from european countries to our website." to make the most out of cdc's website popularity, visitors are also asked to complete a short questionnaire: we have this section on our site "tell us what you think". we get a lot of information from that. we get actually more feedback than we can analyze but we try to read all of it. during h n , we did an eight months survey of , people . . . we have a four question survey on our website, it takes maximum five minutes. it asks about what was the reason for you recent visit, who you are, why are you coming. from that information, cdc is able, among other things, to define target groups for their communication strategy. this strategy relies on a more and more diversified approach. while the importance of "traditional" tools from leaflets to print media is still recognised, online tools and the social media become increasingly significant: right now we prepare information for twitter . . . during h n , we gained almost one million followers in the first week. since then it's grown only around %, so that was a teachable moment. other tools are popular too, widgets, or badges. the email updates were very popular during h n . once again, the information sought by others through twitter, email updates or website surfing is turned into a source of real-time information about what, where and what kind of people are concerned. cdc communication experts use this information to tailor and craft messages for specific target groups. according to cdc risk experts, the public needs advice that comes in "manageable bites". instead of asking too much (eg staying at home and taking weeks off of work etc), "you need to do it in baby steps". for h n , the most important message was vaccination: as a public health agency, our default message is, go and get vaccinated. our focus was early on to inform the risk groups well, those people who were at the highest risk in terms of death and disease rate. and that was pregnant women. early on we knew this was our main target group and we could craft our messages carefully for this group. to do that, we worked with our partner groups (physicians, nurse groups and so on) and we got the people together for discussing our communication strategy. we took mainly what the media was already saying and crafted messages that would say you shouldn't be around sick people and the obstetricians backed that up and made clear that the vaccine is safe. and if you split the vaccination rate by groups, you can see how effective we were: the vaccination rate for pregnant women was to %. this shows we got the message through. so we were quickly able to adverse events early on and to monitor in real-time what the effects were. sometimes, the cdc communication team had to be even more active then "just" disseminating what they had: with h n , we had a misinformation quest. there was this anti-vaccine blog that was recommending not to take the vaccine, mainly saying it wasn't effective. so we were able to address this and funnel specific information there. it's hard to tell whether it worked or not. maybe the supply was more of a problem than the vaccination rate and i think the rate was pretty high, especially among the targeted risk groups. and yes, the blog in question toned down their language. i mean, they didn't stop what they were doing but they were less general and more informative. once again, cdc's strategy was successful by its own standards. they provided information to the public via many different channels and vaccination rates showed that they "got the message through". regarding cdc's response to h n , former cdc director david j. sencer commented: perhaps the primary lesson learned from this pandemic will be that while decision-making is always risky, that risk can be minimized through effective communications . . . [o] n balance, the response has been a success and so far, the ultimate test of management has been met: no one has been fired (sencer :s -s ). on the grand scale of nations and supranational organisations, pandemic anxieties are met with securitisation efforts, entailing practices that install or enforce centralised chains of command, emphasise territorial borders and advocate restrictions of movement. on the scale of public health agencies such as cdc, pandemic anxieties resonate with other, "institutionalised" anxieties. in the case of h n , at least three anxieties at cdc were crucial: anxieties over the quality or "accuracy" of data; anxieties over how to deal with the media and striking a balance between raising awareness and not being alarmist; and anxieties over staying informed and being the first ones to know. these anxieties are neither new nor foreign to pre-securitised public health. nevertheless, pandemic anxiety certainly augments these "institutionalised" anxieties and makes them more pressing issues. they need to be worked through by employing various strategies and practices. the sense of urgency engendered by pandemic anxiety creates time compression for those involved in emergency response. over fears that speed threatens to compromise the validity of scientific data, resistance to constant calls for new data becomes a vital strategy. by putting the data into context, public health and communication experts try to "get the message through" without creating panic or giving the media reason for alarmist reporting. staying informed and the need to be the first ones to know is achieved through ever more sophisticated surveillance systems. at times, the new systems turn around the relationship between those who seek information and those who provide information: by registering for any cdc alert service or calling the hotline, cdc gets crucial information about emerging health-related worries and its whereabouts in real time. the latter practice of creating more sophisticated surveillance systems feeds back into general pandemic anxiety. the more early detection tools are installed, the more instances of worrying information will be gathered. this in turn contributes to calls for constant vigilance that are met with further securitisation efforts. it is difficult to say whether this is necessarily a "vicious cycle". taking the view from within cdc, securitisation has brought about changes for better and worse. being more attuned to the need for real-time data and the need to be constantly aware of emerging threats is certainly nothing that troubles public health experts and scientists as such. as one respondent phrased it: "preparing for the worst is a good thing to do and nothing that should be incriminated . . . [it]'s part of the job, always foreshadowing what could happen but without being sensational . . . [the problem is], in the ensuing discussion, hindsight seems to be more important than good decision-making." however, as we have more and better technologies at hand that help us to become aware of harmful emerging ecologies such as the changing territories of new infectious diseases, it is very likely that the chain of pandemic anxiety events proliferates and intensifies. promoting a critical understanding of how pandemic anxieties work can help in evaluating their importance. historically, slower modes of detection meant that awareness of the emerging threat was perhaps closely related to actual fatalities. nowadays, we are already aware of the potential threat before we have seen what course it will take. under these circumstances, pandemic anxieties are more and more likely to be based on anticipating the characteristics of the new pathogen rather than actual disease and deaths. thus, the new powers derived from rapid detection technologies need to be critically appraised since we have not yet developed a pragmatic culture of living with constant emergency. who.int/en/what-we-do/health-topics/diseases-and-conditions/influenza/pandemicinfluenza/about-pandemic-phases, accessed july ). biosecurity: spaces, practices, and boundaries biopolitics and the molecularization of life public prophylaxis: pandemic influenza, pharmaceutical prevention and participatory governance swine influenza a (h n ) infection in two children-southern california outbreak of swine-origin influenza a (h n ) virus infection-mexico reflections on the uk's approach to the swine flu pandemic: conflicts between national government and the local management of the public health response biosecurity: towards an anthropology of the contemporary london: earthscan cste (council of state and territorial epidemiologists) ( ) national reporting for initial detections of novel influenza a viruses. council of state and territorial epidemiologists position statement cambridge: polity dawood f, jain s, finelli l et al; novel swine-origin influenza a (h n ) virus investigation team ( ) emergence of a novel swine-origin influenza a (h n ) virus in humans toward the medicalization of insecurity. cambridge: polity farmer p ( ) infections and inequalities. the modern plagues biosecurity in the global age: biological weapons, public health, and the rule of law towards a sane and rational approach to management of influenza h n influenza a (h n ) and pandemic preparedness under the rule of international law securing life: the emerging practices of biosecurity aldershot: ashgate institute of medicine ( ) emerging infections: microbial threats to health in the united states anxiety as social practice c the author. antipode c antipode foundation ltd multiculturalism, racism and infectious disease in the global city: the experience of the sars outbreak in toronto dangerous fragments security, disease, commerce: ideologies of post-colonial global health the influence of anxiety: september , bioterrorism, and american public health the scale politics of emerging diseases two regimes of global health novel swine-origin influenza a virus in humans: another pandemic knocking at the door the site of the social: a philosophical account of the constitution of social life and change swine-origin influenza triple-reassortant swine influenza a (h ) in humans in the united states from global flu to global health swine flu c the author. antipode c antipode foundation ltd many thanks to the people at cdc who were kind enough to show me around and answer my questions; the editor rachel pain for her motivation and patience; and the four anonymous reviewers for their insightful comments. the research was made possible by generous support from dfg (german research foundation). key: cord- - dlthaqv authors: balajee, s. arunmozhi; pasi, omer g.; etoundi, alain georges m.; rzeszotarski, peter; do, trang t.; hennessee, ian; merali, sharifa; alroy, karen a.; phu, tran dac; mounts, anthony w. title: sustainable model for public health emergency operations centers for global settings date: - - journal: emerg infect dis doi: . /eid . sha: doc_id: cord_uid: dlthaqv capacity to receive, verify, analyze, assess, and investigate public health events is essential for epidemic intelligence. public health emergency operations centers (pheocs) can be epidemic intelligence hubs by ) having the capacity to receive, analyze, and visualize multiple data streams, including surveillance and ) maintaining a trained workforce that can analyze and interpret data from real-time emerging events. such pheocs could be physically located within a ministry of health epidemiology, surveillance, or equivalent department rather than exist as a stand-alone space and serve as operational hubs during nonoutbreak times but in emergencies can scale up according to the traditional incident command system structure. capacity to receive, verify, analyze, assess, and investigate public health events is essential for epidemic intelligence. public health emergency operations centers (pheocs) can be epidemic intelligence hubs by ) having the capacity to receive, analyze, and visualize multiple data streams, including surveillance and ) maintaining a trained workforce that can analyze and interpret data from real-time emerging events. such pheocs could be physically located within a ministry of health epidemiology, surveillance, or equivalent department rather than exist as a stand-alone space and serve as operational hubs during nonoutbreak times but in emergencies can scale up according to the traditional incident command system structure. e very country needs a system for responding to emergencies and managing emergency response. emergency operations centers (eocs) are increasingly viewed as necessary components of emergency preparedness and are used for multiagency coordination and response to a variety of hazards, including natural disasters, chemical spills, radionuclear incidents, humanitarian emergencies, and disease outbreaks. public health eocs (pheocs) are physical spaces with the ability to monitor events using various sources of data, improve communication between public health and emergency management personnel, facilitate coordination with multiple response partners, and provide space for members of the incident command team to gather and work ( ) ( ) ( ) ( ) ( ) ( ) ( ) . when activated, a pheoc is a location for the coordination of information and resources and is staffed with teams of subject matter experts, analysts, logisticians, and support staff ( , ) . during activation, pheocs monitor epidemiologic data and field reports from a variety of sources using data technologies and informal networks of public health professionals ( , ) . scalability is essential for maintaining the effectiveness of a pheoc ( ) , and it can be partially or fully activated according to situational needs ( ) . when inactive, many pheocs reduce in size or become dormant, and routine surveillance activities continue elsewhere within a ministry or department of public health ( , , ) . in the united states, the centers for disease control and prevention (cdc) has a , -square-foot pheoc staffed by trained personnel hours per day, days per year, on cdc's main campus in atlanta, georgia ( ). the cdc pheoc may be notified about potential public health threats through its watch desk, which receives calls primarily from clinicians and other state and local entities, including pheocs. notification also can come from public health partner briefings, field operations intelligence, reports from media and the internet, and the international health regulations reporting system maintained by the world health organization (who) ( ) . although the cdc pheoc houses a unit that monitors a wide variety of media sources for reports of outbreaks, most routine domestic surveillance data are collected and analyzed by the states and individual pathogen-or diseasespecific programs within cdc. for instance, cdc's influenza division collects, compiles, and analyzes information about influenza activity year-round in the united states. this information is communicated to the public in fluview ( ), a weekly influenza surveillance report, and fluview interactive ( ) , which enables in-depth exploration of influenza surveillance data. the cdc pheoc can access and view fluview / but relies on experts in the influenza division to analyze and interpret data and identify major aberrations. if an aberration in the data was thought to represent an event with public health consequences, such as the emergence of a new influenza virus rapidly spreading among humans, the pheoc would be activated and all influenza surveillance activities moved into it during the period of activation. since its official launch in , the cdc pheoc has been central to cdc's timely and efficient coordination of public health threats and has responded to ≈ domestic and international public health threats, including hurricanes; foodborne disease outbreaks; the a(h n ) influenza pandemic; the haiti cholera outbreak; and the outbreaks of middle east respiratory syndrome, ebola virus infection, and zika virus infection ( ) . although the cdc pheoc has been a successful model in the united states, it might be less relevant for resource-limited countries. maintaining a freestanding, constantly staffed pheoc with a large dedicated workforce might be prohibitively expensive. in addition, recruiting a highly skilled epidemiologic workforce for an eoc might be challenging in these countries. furthermore, the cdc pheoc conducts surveillance on a global scale, whereas some countries may prioritize a more regional or national focus and thus might not have the ability or the need to scale up human and technical resources to tackle public health threats on the international stage. countries face challenges with surveillance and outbreak response because of ) fragmented data streams that do not enable easy access to raw data for timely analyses and data use, ) a small workforce that is responsible for most surveillance and response-related activities, ) poor coordination during outbreaks resulting in slow response, and ) limited resources dedicated to public health ( , , , ) . to mitigate these challenges, pheocs in global settings can serve as epidemic intelligence hubs by receiving, analyzing, and visualizing multiple data streams, including surveillance data, and being staffed with a trained workforce capable of analyzing and interpreting data in real time. such pheocs can be embedded within a ministry of health epidemiology, surveillance, or equivalent department, rather than existing as a standalone space, and can operate continuously for routine health surveillance. the global health security agenda (ghsa), officially launched in , was developed to strengthen countries' capacity to prevent, detect, and respond to human and animal biologic threats ( , ) . the -year target for ghsa's emergency operations centers action package is that "every country will have a public health emergency operations center functioning according to minimum common standards; maintaining trained, functioning, multi-sectoral rapid response teams (rrts), 'real-time' bio-surveillance laboratory networks and information systems; and trained eoc staff capable of activating a coordinated emergency response within minutes of the identification of a public health emergency" ( ) . with the launch of ghsa and the need to develop pheocs and surveillance response capacities in countries around the world, we outline a sustainable model for pheoc operations. such pheocs will operate continuously by maintaining routine surveillance activities and serving public health needs during outbreak and nonoutbreak periods, thereby ensuring sustainability and helping address other national needs, such as routine analyses and use of surveillance data. we illustrate this approach with case studies. vietnam has technically strong regional institutes with moderately advanced laboratory and epidemiologic capacity, resulting in scores of or out of for laboratory and surveillance capacity indicators using the joint external evaluation of the international health regulations core capacities tool ( ) . these institutes oversee public health activities in their respective regions (north, south, central coast, and central highland), including the response and management of outbreaks that are beyond the capacity of local health departments. nationally, the general department of preventive medicine (gdpm), an agency within the ministry of health, provides public health policy and the strategic direction of public health activities, including surveillance. the gdpm developed a national pheoc with the support of cdc and the us defense threat reduction agency's cooperative biologic engagement program as part of a ghsa demonstration project in . since then, the pheoc has been used to manage responses and risk assessments to several different threats, including a nationwide measles outbreak, concerns about the importation of ebola virus infection and middle east respiratory syndrome, and recently, the emergence of zika virus infection. the national pheoc conducted and coordinated several training sessions for ministry of health and regional institute personnel on basic public health emergency management, facilitated participation for gdpm and regional institute staff in cdc's public health emergency management fellowship training program, and has conducted several tabletop exercises and drills. a comprehensive pheoc operational handbook was also developed and recently disseminated throughout the country's public health system ( ) . vietnam has several surveillance systems that generate data from a variety of sources. hospitals are required to routinely report notifiable diseases, including several high-risk illnesses that must be reported within hours. typically these data are transmitted through the public health system from communes and districts to the province level, and then the regional institutes, through aggregated reports, submit these data to an electronic communicable disease surveillance software. since july , , the ministry of health has been rolling out a system of case-based reporting on the established backbone of aggregated data reporting. in addition, multiple separate sentinel surveillance networks monitor for japanese encephalitis virus; hand, foot, and mouth disease; influenza-like illness; severe acute respiratory infections; and dengue virus infection. each system has an independent reporting mechanism, but all are monitored by the same small group of regional institute-level epidemiologists. surveillance for malaria, tuberculosis, and hiv infection also have separate reporting systems. each regional institute has a public health laboratory system, but the laboratories are not directly connected to the epidemiology or disease control departments that monitor for outbreaks. in addition to these indicator-based surveillance systems, event-based surveillance systems recently have been improved in vietnam, where community health workers and healthcare providers can report unusual events through public health reporting networks. the fragmentary nature of the surveillance data available through diverse reporting sources impedes timely detection of outbreaks, making the creation of integrated data systems critical to the success of these pheocs. to help mitigate these challenges, the vietnam ministry of health envisioned a network of pheocs that will be an interlinked system of information hubs, one at each regional institute. each pheoc will be connected to the network through its own data warehouse, which is in turn connected to the national data warehouse at the national pheoc at gdpm. the warehouses incorporate and integrate data from multiple surveillance sources and enable analyses with the district health information system software platform ( ) . for immediate accessibility, data dashboards with automated analyses are being created for each high-priority disease, enabling surveillance staff to instantly see the status of disease cases in their region. alert thresholds for specific endemic seasonal diseases, such as dengue and influenza, have been designed to trigger notifications to the regional institutes. the national institute of hygiene and epidemiology (nihe) in hanoi and the pasteur institute of ho chi minh city (pi-hcmc) lead the surveillance and outbreak response for the north and south regions, respectively, and collaborate with gdpm. nihe has completed the establishment of a pheoc, and pi-hcmc is in the process of doing the same. vietnam plans to develop additional pheocs in the remaining regional institutes in . both pheocs (nihe and pi-hcmc) are situated physically and administratively in departments of epidemiology or disease control at the regional institutes and are staffed by epidemiologists within those departments, the same epidemiologists responsible for routine surveillance. a small number of support staff, including full-time pheoc managers and information technology staff, are being recruited. during nonoutbreak times, the pheocs will be surveillance hubs where data from notifiable disease reporting from healthcare facilities, sentinel surveillance sites, and public health laboratory systems are all available through the data warehouse and displayed on data dashboards that automate routine analyses. epidemiologists in each pheoc will monitor and interpret the various streams of surveillance data to define usual patterns of disease transmission and monitor for aberrations. data also are summarized for weekly distribution to policy makers in the moh. the pheocs also will receive and incorporate event reports from the media, community, healthcare facilities, and event-based surveillance systems, enabling more timely detection of emerging or small outbreaks. separate real-time data dashboards are in place for priority diseases, such as zika virus infection (online technical appendix figure, https://wwwnc.cdc. gov/eid/article/ / / - -techapp .pdf). after who declared zika virus infection as a public health emergency of international concern, the national pheoc at gdpm began operating as a nerve center for zika virus preparedness and response ( ) . through the institution of a national preparedness and response plan, ongoing data surveillance, and multiagency meetings, the vietnam pheoc network has monitored and documented the zika epidemic in the americas and tracked cases within vietnam. the vietnam pheocs also are training centers for vietnam's field epidemiology training program (fetp). that program recently inducted full-time fellows for the first time in . these fellows rotate through the pheocs, where they are responsible for analyzing surveillance data and writing data summaries. ultimately, the development of vietnam's pheoc policies and operating procedures had to be tailored to the specific context of the country's existing legislative background. formal pheoc activation at cdc mobilizes financial resources for outbreak response and mobilizes personnel from other departments within the organization, which expedite the processes usually required for travel authorization and the clearance of communications materials. in vietnam, however, these same actions are accomplished by the formal declaration of an "outbreak," which carries a specific legal meaning. this legislation, which long preceded development of a pheoc, had to be taken into account when the eoc guidelines and manual of operations were drafted. cameroon has experienced nearly annual cholera outbreaks and separate outbreaks of measles in and continues to encounter major challenges in containing these outbreaks. obstacles to efficient containment of outbreaks include reporting lags from the field, delays in information sharing of outbreak data through the public health system, inefficient coordination of outbreaks, and slow response at the central level ( , ). the integrated disease surveillance and response (idsr) system is the framework for cameroon's disease surveillance and response. public health policies, supervision and management of the health system, and idsr at the central level are the responsibility of ministère de la santé publique (minsante), the cameroon ministry of health. cameroon has regions with regional health delegations, and each is responsible for public health surveillance and response. each region is further divided into districts, and the districts are additionally divided into health center catchment areas. these health center catchment areas are the outmost peripheral health units and may have community health volunteer networks. aggregated reports of idsr notifiable diseases are sent weekly from the districts to min-sante, and the process is completed by manual data entry shared by email. in , cameroon began developing a pheoc, and minsante prioritized its establishment to improve outbreak coordination, management, and response. the pheoc was developed in the capital city, yaoundé. it was created after several trainings of minsante personnel, including training on the incident management system, participation in cdc's public health emergency management fellowship training program, and the execution of several tabletop exercises and simulations. this knowledge was shared within the country, through a course taught by the newly hired pheoc manager, with support from cdc subject matter experts. the pheoc was activated in may in response to an avian influenza virus a(h n ) outbreak on a poultry farm in yaoundé to enable the early detection of human cases, respond rapidly to interrupt human transmission, and oversee case management. a veterinary fetp fellow served as the liaison between the pheoc and minepia, cameroon's ministry of livestock, fisheries, and animal industries, coordinating seamless communication between the national veterinary laboratory and the pheoc. when the pheoc was deactivated in june , none of the human contacts had tested positive ( ) . during the avian influenza outbreak, the pheoc faced a challenge in securing tamiflu (oseltamivir phosphate) (genentech, south san francisco, ca, usa), an antiviral medication used to treat persons with symptoms caused by influenza. early in the pheoc's activation, all existing national stocks of tamiflu were recognized to have expired, leaving the country unprepared for human cases. working with who, the pheoc obtained tamiflu. when ghsa was launched in cameroon, minsante understood that cameroon could not wait for another outbreak and needed to begin operating the national pheoc immediately. minsante positioned the pheoc as a hub to coordinate resources, information, and communication for data receipt, integration, analyses and interpretation, and coordination, with less focus on the physical infrastructure. thus, the pheoc runs out of a small multipurpose room within the minsante facility, and a new facility is being built mearby. the lack of a dedicated physical place has not hindered the pheoc's operation. in alone, the pheoc responded to a cholera outbreak; prepared for a lassa fever outbreak when it broke out in neighboring nigeria; responded to measles, monkeypox, and avian influenza virus a(h n ) outbreaks; elaborated on contingency plans for zika virus; fine-tuned monkeypox plans when human cases and fatalities were registered in neighboring central african republic; and preventively activated for wild poliovirus detected in nigeria. most recently, the pheoc responded to a train derailment in the ezeka district, demonstrating all-hazards response capability. all of these opportunities helped cameroon improve its preparedness, reducing its response time from weeks to hours during the recent h n influenza outbreak (table) . engaging cameroon's fetp within the newly created pheoc was a critical component of the design of the country's pheoc. the fetp trainees are forming the critical workforce that regularly analyze idsr data from the district, interpret results, and present the results to stakeholders each week. these epidemiologic meetings are led by fetp trainees at the pheoc and include stakeholders from who, unicef, the national public health laboratory, centre pasteur of cameroon, international medical corps, metabiota, masanté, cdc, various officers from concerned directorates, and surveillance teams from minsante, among others. this ethos of cooperation and stakeholder engagement was crucial for coordination meetings later, during the h n influenza activation. as the concept of incident command started to take shape, it became apparent that major gaps in the cameroon health system had been secondarily bridged: more accountability and better coordination. the lack of these attributes previously were the major cause of poor initial response to the wild poliovirus outbreak ( - ) ( ) . cameroon's pheoc faces many challenges, including a time lag in data availability from districts because of manual collection and reporting of data and limited information systems capacity to collect and analyze information from diverse data sources. to address this challenge, minsante is investing in a data warehouse and an automated software platform at the district, regional, and national levels to make data available in near real time to decision makers at each level and to enable information flow into the pheoc. work is also under way to build capacity for automated data analysis and visualization at the pheoc. developing pheocs to facilitate appropriate coordination, response, and management of public health events is essential for building countries' emergency response capacity. experience gained from developing pheoc capacity in vietnam and cameroon demonstrated the following as a recommended sustainable path for pheoc development: . pheocs benefit from being housed physically and administratively in close proximity to or within the epidemiology or surveillance departments of the ministry of health. this closeness establishes the pheoc as a working hub readily accessible by epidemiologic staff. . pheocs should be epidemic intelligence hubs to receive, interpret, and visualize surveillance data from multiple sources. these hubs make information systems development a critical part of pheoc operations. mechanisms should be created that integrate data streams and develop data dashboards, automate routine analyses to improve the value and utility of surveillance data, and establish the continuous operations of the pheoc. . rotating fetp trainees through the pheocs provides the epidemiologic workforce needed for analysis and interpretation of surveillance data. this rotation can augment epidemiology workforce capacity, especially in ministries of health where epidemiology staffing is limited. it also provides a valuable training experience for fetp fellows. . pheocs should function during nonoutbreak periods, and surveillance data should routinely be interpreted by an epidemiologic workforce. such an "always on" pheoc facilitates the rapid transition to response mode during outbreaks and improves the cost-effectiveness of the infrastructure investment. routine use of pheocs during outbreaks and during nonoutbreak periods helps ensure sustained technical capacity for data analyses, interpretation, and visualization tools and equipment, as well as the knowledge to analyze and interpret incoming health information. . each pheoc must be tailored to the legislative context in which it is situated. the result is a pheoc that fits within local legislation and more fully meets the needs of the ministries of health. the who framework for a public health emergency operations centre provides valuable information about the role, function, and construction of pheocs ( , ). a critical gap exists in guidance, however, regarding how pheocs maintain readiness between periods of activation. this gap in guidance is particularly relevant for resourcelimited nations that might not be capable of readily scaling up human resources and technical capacity in the event of an emergency. it is more sustainable for pheocs in these countries to initially be established in departments or institutions that are already responsible for monitoring public health data and responding to disease outbreaks. illustrations from vietnam and cameroon present the implementation of this approach and its associated successes and challenges. the approach described here could enable rapid establishment of a pheoc with minimal infrastructure and available workforce. such a pheoc will serve well in resource-limited settings as a continuously operational hub for surveillance, yet ready for activation during emergencies. as additional resources become available, this pheoc model can expand to fit international standards and be capable of addressing all emergency hazards. we thank andré mama fouda and the government of cameroon for their engagement and support to the ghsa. we thank all technical partners (who, unicef, centre pasteur of cameroon, international medical corps, metabiota, masanté, world health organization. framework for a public health emergency operations center world health organization. a systematic review of public health emergency operations centers (eoc) trends and directions of global public health surveillance blackout of : public health effects and emergency response from sars to h n influenza: the evolution of a public health incident management system at cdc world health organization. strengthening health security by implementing the international health regulations pan american health organization. emergency operation center cdc's emergency management program activities-worldwide the methods of public health global health security: international health regulations (ihr) centers for disease control and prevention. fluview interactive governance challenges in global health world bank public health surveillance toolkit: a guide for busy task managers moving ahead on the global health security agenda emergency operations centers action package joint external evaluation of ihr core capacities of vietnam strengthening global health security capacity-vietnam demonstration project ihr ) emergency committee on zika virus and observed increase in neurological disorders and neonatal malformations recurrent epidemic cholera with high mortality in cameroon: persistent challenges years into the seventh pandemic addressing h n highly pathogenic avian influenza: qualitative risk assessment on spread in the central african region polio eradication: update on situation in cameroon french and german cooperation, the chai) in cameroon for sustained support to the government of cameroon, and for building the foundation, during the response to ebola virus disease, on which ghsa is resting. we also thank nguyen thanh long, dang duc anh, the ministry of health's national institute of hygiene and epidemiology, and other ministry of health departments and agencies for their support to the gsha, particularly with the establishment of the pheoc. we thank tran dai quang and tran anh tu for their dedicated and hard work on creating the dashboards. we are also thankful to the us defense threat reduction agency's cooperative biologic engagement program under the us department of defense and path for their great commitment and support to stand up the pheoc at gdpm and nihe.dr. balajee is associate director for global health sciences, division of viral diseases, in the national center for immunization and respiratory diseases, cdc. her research interests include strengthening capacities in resource-limited settings for early detection of events, rapid reporting, and appropriate response, to prevent the spread of infectious diseases. key: cord- -zobx rw authors: gao, george f. title: for a better world: biosafety strategies to protect global health date: - - journal: biosafety and health doi: . /j.bsheal. . . sha: doc_id: cord_uid: zobx rw abstract biological threats, whether naturally occurring, accidental, or deliberate in origin, can result in disasters that are regional, national, or even global in scope if not properly contained. many global communities, international programs, and governmental organizations have been established to mitigate these risks and challenges. in china, for example, the government has systematically implemented long-term plans including a complete country-wide architecture for biosafety management. it includes the establishment of a series of improved biosafety laws/regulations/standards and of a large number of high-level biosafety laboratories. all countries should encourage preparedness and improve surveillance systems to predict, identify, and respond to the next public health crisis. more grants and funds should be established for research into biosafety and biosecurity. most importantly, international collaborations, partnerships, and communications should be enhanced. the journal biosafety and health aims to provide a global communications platform on biosafety related to human and animal health. the release of biological agents, whether due to natural, accidental or deliberate causes, is among the most serious challenges to humanity. due to globalization, biological threats have the potential to spread rapidly from one country to many others in a short amount of time, resulting in epidemics/pandemics, psychological trauma and economic and social breakdown [ ] . emerging and re-emerging infectious diseases have raised global concern in recent years. urbanization, habitat encroachment, and increased intercontinental travel and commerce, in combination with localized inefficiencies in health-care systems, increase the possibility that infectious diseases will spread rapidly around the world. unpredictable outbreaks that were previously localized can spread globally, as fast as an international flight. as a result, we must accept the fact that in today's world, "a threat anywhere is a threat everywhere". the year marked the th anniversary of the spanish flu pandemic, which resulted in~ million casualties, more than the death toll from the first world war [ , ] . this pandemic is considered the deadliest in modern history. since the beginning of the st century, the world has experienced a series of major crises due to outbreaks of infectious diseases. in , the severe acute respiratory syndrome (sars) epidemic affected over people with a mortality rate about . %, sparking global fear and panic [ ] . other epidemics included the emergence/re-emergence of h n influenza ( , ) [ , ] , vibrio cholerae in haiti ( ), pandemic "swine flu" h n ( ), middle east respiratory syndrome (mers) ( ), ebola virus disease in west africa ( ), and yersinia pestis in madagascar ( ). in , a substantial increase in the number of lassa fever cases were recorded in nigeria, nipah virus infections in india, as well as two distinct ebola virus disease outbreaks in the democratic republic of congo, one of which is still ongoing. as such, infectious diseases will remain a major threat to public health for the foreseeable future. another significant threat to global health is the emergence of antimicrobial resistance (amr). microbial pathogens readily acquire resistance to commonly used drugs and in many cases, can transmit this resistance to other microbes. currently we are seeing the worldwide emergence of multidrug-resistant organisms against which we have little or no defense, and it is estimated that amr will account for an extra million deaths a year globally by if no action is taken [ ] . amr has been included as a focus in the biosafety strategies of several different countries [ , ] , including the national security risk assessment of the uk as a tier one risk [ ] . the ever-increasing human population and their encroachment on undeveloped areas inhabited by wild animals have led to the emergence of previously unknown diseases. zoonotic infections, transmitted from animal hosts to humans, account for approximately % of total biosafety and health j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / b s h e a l infectious diseases in humans, and % of all new and emerging infectious diseases [ ] . importantly, the infectious disease outbreaks during the st century have all virtually arisen from zoonotic infections. additionally, we also face the impact of emerging plant and animal diseases on agricultural production (the most recent being african swine fever virus in china), which have world-wide implications despite not posing a direct threat to human health. as such, the one health concept has raised a world-wide call for collaboration to attain optimal health for human, animals, and the environment [ ] . man-made biological threats exist in many countries. a potential major risk stems from stocks of concentrated infectious pathogens stored in laboratories and the absence of adequate biosecurity measures. noncompliance of approved biocontainment and biosafety protocols could result in the accidental or deliberate release of pathogens into the environment through a laboratory-acquired infection or a bioterrorist attack. advances in biomedical technologies, such as genome editing and synthetic biotechnology, have the potential to provide new avenues for biological intervention in human diseases. these advances may also have a positive impact by allowing us to address risks in new approaches. however, the proliferation of such technologies means they will also be available to the ambitious, careless, inept, and outright malcontents, who may misuse them in ways that endanger our safety. for example, while crispr-related techniques provide revolutionary solutions for targeted cellular genome editing, it can also lead to unexpected off-target mutations within genomes or the possibility of gene drive initiation in humans, animals, insects, and plants. similarly, genetic modification of pathogens, which may expand host range as well as increase transmission and virulence, may result in new risks for epidemics. for example, in , several groups showed that influenza h n viruses with a few nucleotide mutations and h n isolates reasserted with pandemic h n virus could have the ability for airborne transmission between ferrets [ ] [ ] [ ] [ ] . likewise, synthetic batorigin sars-like coronaviruses acquired an increased capability to infect human cells [ ] . thus, modifying the genomes of animals (including humans), plants, and microbes (including pathogens) must be highly regulated. to deal with these biological risks and challenges, international partnerships have been formed to assess and reduce the risks, and to tackle such threats at their source. the international federation of biosafety associations (ifba), formerly the international biosafety working group, was established in and is currently a thriving global community for promoting the safe and secure handling of biological materials [ ] . the american biological safety association international (absa international) was founded in and now not only serves the growing needs of biosafety professionals in the us, but also engages in broad international communication with other associations throughout the world. other regional associations include the european biosafety association (ebsa) and the asia pacific biosafety association (a-pba), founded in and , respectively, representing countries in europe and in asia-pacific regions. since its establishment in , the who has pioneered the development of surveillance networks for the monitoring and control of emerging and re-emerging infectious diseases. these networks involve programs initiated by the who as well as alliances with independent programs, such as the global influenza surveillance and response system (gisrs, https://www.who.int/influenza/gisrs_laboratory/en/) and the global infection prevention and control network (gipcn, https://www.who. int/csr/bioriskreduction/laboratorynetwork/gipc_next_steps/en/). the global health security agenda (ghsa), a new multisectoral, inter-agency governmental approach to cope with global infectious disease threats, was launched in by the usa and its international partners. in addition to working with partner countries around the world on the biosafety and biosecurity, the ghsa is also committed to mitigating the impact of naturally occurring outbreaks as well as accidental/deliberate releases of dangerous pathogens [ , ] . the global virome project (gvp) launched in by specialists from the usa, china, brazil, italy, and nigeria will help identify the bulk of the viral threats and provide timely critical data support for public health interventions against future pandemics [ , ] . the sars epidemic in - wreaked havoc on both the society and economy of china [ ] , highlighting the urgent requirement to establish a modern biosafety management system in china. to achieve this objective, the chinese government formulated and systematically implemented a long-term plan including a complete architecture for biosafety management. this framework was characterized by a series of laws, regulations, and standards involving different departments, organizations, and institutes in china. based on this, many bsl- laboratories and a few bsl- laboratories have been built since. meanwhile, the largest network in the world for the surveillance of a diverse spectrum of emerging pathogens was established [ ] . this network implemented and maintained strict biosafety regulations in over laboratories with different hierarchical levels, from national to provincial reference laboratories, as well as in sentinel hospitals. this coordinated, nationwide biosafety laboratory network ensures the early-warning and prevention of pathogen spread, and prompts initiation of clinical treatments in china. china has also expanded broad international collaborations with other countries for the improvement of global biosafety. during the - ebola virus disease epidemic in west africa, a mobile bsl- lab and a fixed bsl- lab supported by chinese specialists greatly contributed to the control of further infections [ ] . the fixed bsl- lab is still playing a pivotal role in the system for disease control in sierra leone [ ] . in , the th a-pba biosafety conference was successfully held in beijing, china. this conference, the st international biosafety conference to be held in china, was co-chaired by prof. guizhen wu from the national institute for viral disease control and prevention, chinese center for disease control and prevention (china cdc), and ms. t.s. saraswathy subramaniam, the president of the a-pba. recently, the peer-reviewed journal biosafety and health was founded. this journal, published in english, is sponsored by the chinese medical association, managed by national institute for viral disease control and prevention, china cdc, and distributed by elsevier b.v. in amsterdam. biosafety and health will provide an academic exchange platform for new achievements and developments in the field of biosafety related to human, animal and environmental health. this journal will track research breakthroughs in the field of biosafety, guide international research directions, and publish new theories and new technical methods in a timely manner. meanwhile, cooperation and exchange between china and international communities will be accelerated by this journal. biosafety and health will be edited by two distinguished scientists, dr. guizhen wu as the editor-in-chief, and dr. jianwei wang as the executive editor-in-chief. currently, members of editorial board consist of scientists from different countries. one of the most significant challenges faced by humanity in the st century is the rapid, global spread of infectious diseases, which have the potential to cost millions of lives, disrupt social order, and greatly damage global travel and commerce. thus, it is pivotal to mitigate the risk of biological incidents. recent outbreaks of emerging and deadly viruses have highlighted a global vulnerability to public health emergencies. countries around the world and international communities need to boost preparedness, and improve surveillance systems to predict, rapidly identify, and respond to the next public health crisis [ ] . these systems need to be sensitive enough to cope with the challenges of emerging and re-emerging infectious diseases, risks associated with advances in biotechnology, and bio-terrorism threats. meanwhile, to address biological threats, more grants and funds should be established for the development of better antibiotics, antiviral drugs, and efficient therapies. in underdeveloped and developing countries, both biosafety-related hardware (i.e. biosafety laboratories) and technical expertise are urgently needed. international collaborations, partnerships, and communication should be enhanced. the proper and timely sharing of biosafety achievements, including infectious diseases prevention and control, amr, genome editing, and synthetic biotechnology, will promote the capacity of all the partners to control current and future biological-related threats, guaranteeing human health. with this journal, biosafety and health, we have a biosafety communications platform for everyone, for anyone, and for all. let's work together for a better world. a"iv to "z"ikv: attacks from emerging and re-emerging pathogens on the centenary of the spanish flu: being prepared for the next pandemic towards our understanding of sars-cov, an emerging and devastating but quickly conquered virus re-emergence of fatal human influenza a subtype h n disease highly pathogenic h n influenza virus infection in migratory birds uk biological security strategy national security strategy and strategic defence and security review risk factors for human disease emergence influenza and the live poultry trade airborne transmission of influenza a/h n virus between ferrets h n influenza viruses are transmissible in ferrets by respiratory droplet h n hybrid viruses bearing /h n virus genes transmit in guinea pigs by respiratory droplet characterization of h n influenza a viruses isolated from humans synthetic recombinant bat sars-like coronavirus is infectious in cultured cells and in mice bridging the gap: the international federation of biosafety associations editorial: biological engagement programs: reducing threats and strengthening global health security through scientific collaboration reassessing biological threats: implications for cooperative mitigation strategies, front the global virome project building a global atlas of zoonotic viruses china in action: national strategies to combat against emerging infectious diseases on the ground in sierra leone on the ground in western africa: from the outbreak to the elapse of ebola acknowledgements i would like to thank drs. william j. liu, peipei liu and gary wong for their assistance during the preparation of this manuscript. the author declares that there are no conflicts of interest. key: cord- -xpj vn authors: weigel, ralf; krüger, carsten title: global child health in germany - time for action date: - - journal: global health action doi: . / . . sha: doc_id: cord_uid: xpj vn child health is central to the sdg agenda. universities in the uk and other european countries provide leadership in research and education for global child health to inform related policy and practice, but the german contribution is inadequate. german paediatricians and other child health professionals could make more substantial contributions to the debate at home and internationally, but lack opportunities for scholarship and research. we argue, that there is a momentum to advance global child health in academia and call on german universities to realise this potential. 'viruses don't need visas, pathogens don't need passports' -the world health organization (who) director-general's urgent message to the participants of the world health summit in berlin in is more relevant today than ever [ ] . the impact of the sars-cov- pandemic on children is a powerful reminder in this regard [ ] and other threats are looming [ , ] . germany, like other highincome countries, is a beneficiary of globalisation. however, benefits come with responsibilities: as a signatory of the sustainable development goals (sdg) - , germany committed to advance health globally [ ] . child health and well-being are central to the sdg agenda illustrating our responsibility for future generations [ , ] . unfortunately, global child health in germany is somewhat neglected in research and education. we need a major effort to improve the situation. in germany, global child health institutions and the scientific debate are still in their infancy compared to other european countries. in the uk (uk), the centres at the university college london, the london school of hygiene and tropical medicine, the liverpool school of tropical medicine, and other universities have active research groups in global child health as an integral part of maternal, newborn, child and adolescent health. the royal college of paediatrics and child health annual meetings regularly devote entire days to global child health research and training. global child health topics regularly feature in the college's scientific journal. universities in italy, the netherlands, norway and sweden have institutes dedicated to international maternal and child health. at the universities in utrecht, london and liverpool, under-and postgraduates can attend various courses on global child health. in sweden, the institute for global health transformation initiated a multidisciplinary forum hosted by the royal swedish academy of sciences, which resulted in a roadmap on global child health with five priority areas in the context of the sdgs [ ] . although germany has successful research groups in maternal and child public health that collaborate internationally, for example at the universities in hamburg, heidelberg and munich, there is no such overarching forum to share ideas, to develop strategies and to provide direction. it is the private witten/ herdecke university that has the only professorship for global child health, funded by the friede springer foundation [ ] . the german society for tropical paediatrics and international child health (gtp) is a professional society established almost years ago with about current members which brings together paediatricians with different backgrounds at its annual meetings and offers a range of trainings, but its mandate for research is limited [ ] . the academic global child health landscape in germany is fragmented, without a dedicated chair at a statefunded university and with little collaboration between different actors. however, there are also deeper and more systemic reasons why german global health research and education as a whole are underdeveloped [ , ] . for contact ralf weigel ralf.weigel@uni-wh.de friede springer endowed professorship for global child health, witten/herdecke university, witten , germany example, the abuse of public health by the nazi regime for their racial hygiene policies and atrocities descredited the field and left a stain that still affects perceptions today [ , ] . currently, public health research is concentrated at several federal institutions, such as the robert koch institute (rki) and the federal centre for health education (bzga). but, compared with universities, their scholarly role is limited. at the local level, public health interventions are implemented by public health offices that have no formal academic role [ ] . furthermore, global health policy programmes in germany are distributed over six ministries and international health programmes are funded to a large degree not by the ministry of health but the federal ministry for economic cooperation and development. its main implementers, the society for international cooperation (giz) and the kreditanstalt für wiederaufbau (kfw), a promotional bank owned by the state, have little focus on academic research and education. thus, the historical heritage, and the policy and funding structure appear to be barriers that may have contributed to the slow development of an academic base in global health in general [ ] and global child health specifically. within this historical and structural context and with weakly organised public or global health institutions, it is not surprising that german paediatricians are hard to find in scientific landmark publications, guidelines and reports of global relevance. in the page global strategy - for the health of women, children and adolescents [ ] , a groundbreaking document for the global health of mothers and children, no german name is found in the recognition and author lists, similar to the review articles in the bmj special issue , which provides the scientific background for the strategy [ ] . of the organisations that contributed to the development process of the strategy, only five came from germany [ ] . the same applies to the who publications 'standards to improve the quality of care for mothers and newborn babies in health care institutions' from [ ] and 'standards to improve the quality of care for children and adolescents in health care institutions' from [ ] . among the authors from more than institutions, only three and seven, respectively, are from germany, and only in one case from a paediatric professional society. similarly, of the institutions involved in 'the report of the lancet countdown on health and climate change: ensuring that the health of a child born today is not defined by a changing climate', come from the us, from the uk, five from other european countries, including one from germany, and five from other, non-european countries [ ] . although this lack of representation is not necessarily a sign of a lack of participation in the international scientific debate, the few opportunities german researchers have to engage in global child health research and education at universities suggest that this is, in fact, the case. without academic leadership, a lively exchange of ideas, a research agenda and funding, it is hard to participate and to be heard. without global child health institutes, students and young researchers have few opportunities and academic career prospects, preventing them from engaging in research and applying for funding. our research and educational institutions need to provide a better environment for child health professionals that they can move the global scientific and policy debate forward and contribute more substantially to the global research agenda. many opportunities exist for paediatricians and other health workers caring for children to engage with the realities of global child health in research and education. for example, in / , some , children and their families came to germany to seek refuge, many of them vulnerable with multiple risks and in urgent need of health care [ , ] . their physical and mental health needs and strategies to meet them are important to share [ , ] . what are the enablers and barriers to their integration in the health care and education system, viewed from a child rights perspective [ ] ? germany's development cooperation focus on health systems strenghtening offers further opportunities. the initiative 'hospital partnerships -partners strengthen health' financed by the federal ministry for economic cooperation and development and the else kröner-fresenius foundation, supports projects with institutions from low-and middle-income countries, several of them focusing on mother and child health [ ] . the german academic exchange service (daad) has helped to establish cooperations between universities in germany and low-and middle-income countries with its 'partnership for health care in developing countries' programme [ ] , some addressing maternal and child health. rigorous evaluation of the short and long term effects of interventions implemented within these partnerships, for example on human resources or on child health outcomes, would also make a substantial contribution to the field. it is time for german universities to use this potential to strengthen research and education in global child health -there is momentum to realise this. the sars-cov- pandemic has fuelled a debate of how social determinants, such as access to education, affect health, well-being and development of children in germany and elsewhere [ , ] . children are leading in advocacy for their own for their right to health in the context of climate change, holding world leaders accountable in the fridays-for-future movement. the experiences of families while educating their children at home during lock-downs due to the pandemic as well as the voices of children concerned about climate change are making headlines in the media [ , ] . this may represent an opportunity to leverage global child health concepts, such as social and environmental determinants of health and child rights, higher on the policy and research agenda. as germany is updating its global health strategy, receiving valuable advice from various professional organisations [ , ] , global child health has to become a core element of this strategy, building on and developing further existing initiatives. a recent discussion paper, published by the commission for global child health of the german academy for child and adolescent medicine (dakj), listed several recommendations for improving the landscape of global child health research and education [ ] . in addition, the german society of tropical paediatrics and international child health and the named dakj commission will continue to lobby for the inclusion of global child health into the planned german centre for child health, funded by the federal ministry of education and research [ ] . and the recently founded global health hub germany [ ] and the german alliance for global health research [ ] are also prime opportunities for building institutional capacity. to date, the global child health agenda has had limited visibility in germany. we call on the academic leadership of paediatric professional societies in germany to provide a forum for the scientific and political aspects of global child health, to provide leadership and to lobby for funding from the government. paediatric researchers should respond more actively to calls from multilateral agencies like who [ , ] and make public their positions on issues such as child rights [ ] . medical faculties need to strenghten their academic base by offering under-and postgraduate education in global child health through institutes and chairs so that students and young researchers see a path for their careers. we must now seize the opportunities unfolding for urgently needed engagement in this important field in research and education. german universities can and should play a much more active part in advancing the health and well-being of children throughout the world. viruses don't need visas, pathogens don't need passports early estimates of the indirect effects of the covid- pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study climate change and global child health: what can paediatricians do? the report of the lancet countdown on health and climate change: ensuring that the health of a child born today is not defined by a changing climate united nations department of economic and social affairs. the sustainable development goals report placing children and adolescents at the centre of the sustainable development goals will deliver for current and future generations a future for the world's children? a who-unicef-lancet commission swedish institute fo global health transformation. a new roadmap on global child health germany's expanding role in global health german society for tropical paediatrics and international child health global health education in germany: an analysis of current capacity, needs and barriers global health research and education at medical faculties in germany results presented of the research project confronting the past: contemporary german paediatric response to medical practice in the third reich statutory health insurance in germany: a health system shaped by years of solidarity, self-governance, and competition germany's expanding role in global health every women every child. the global strategy for women's, children's and adolescents health towards a new global strategy for women's, children's and adolescents' health participating organizations: fhi standards for improving quality of maternal and newborn care in health facilities geneva standards for improving the quality of care for children and young adolescents in health facilities accumulated environmental risk in young refugees-a prospective evaluation recommendations for the diagnosis and prevention of infectious diseases in pediatric and adolescent refugees in germany: statement of the german society of pediatric infectious diseases, the society of tropical pediatrics and international child health mental health needs of refugee children in specialized early education and care programs in germany immunization coverage among refugee children in berlin unaccompanied refugee minors in germany: attitudes of the general population towards a vulnerable group else kröner fresenius-stiftung. initiative hospital partnerships pagel -partnerships for the health sector in developing countries covid- and its impact on child and adolescent psychiatry -a german and personal perspective children and adolescents in the covid- pandemic: schools and daycare centers are to be opened again without restrictions. the protection of teachers, educators, carers and parents and the general hygiene rules do not conflict with this after two years of school strikes, the world is still in a state of climate crisis denial we swallowed our misgivings'; statement of the international advisory board on global health: global health centre, the graduate institute of international and development studies deutsche gesellschaft für public health deutschland und sein engagement für die gesundheit der kinder weltweit federal ministry of education and research. startschuss für zwei neue deutsche zentren der gesundheitsforschung deutsche gesellschaft für internationale zusammenarbeit (giz) gmbh. global health hub germany berlin charité global health. german alliance for global health research berlin who hospital care for children guidelines: what do users need? new who standards for improving the quality of healthcare for children and adolescents the budapest declaration for children and youth on the move-comment in the lancet child and adolescent health we thank william christopher buck for proofreading the manuscript. rw wrote the draft manuscript, which ck reviewed. both authors read and approved the final version. rw holds the friede springer endowed professorship for global child health at the witten/herdecke university. ck is currently the chairperson of the german society of tropical paediatrics and international child health and the spokesperson of the committee of global child health of the german academy of child and adolescent medicine. not applicable. the authors have no funding to report. this call to action addresses child health professionals and stakeholders to engage in research and education for global child health at germany's higher education institutions. universities should realise the momentum and recognise the importance of global child health to enable substantial contributions to the scientific and policy debate at the national and global levels. http://orcid.org/ - - - carsten krüger http://orcid.org/ - - - key: cord- -jtj authors: yassi, annalee; gilbert, mark; cvitkovich, yuri title: trends in injuries, illnesses, and policies in canadian healthcare workplaces date: - - journal: canadian journal of public health doi: . /bf sha: doc_id: cord_uid: jtj background: analysis of workers’ compensation data and occupational health and safety trends in healthcare across canada was conducted to provide insight concerning workplace injuries and prevention measures undertaken in the healthcare sector. methods: timeloss claims data were collected for – from the association of workers’ compensation boards of canada. labour force data from statistics canada were used to calculate injury rates. the occupational health and safety agency for healthcare in british columbia coordinated with provincial occupational health and safety agencies in ontario, quebec and nova scotia to analyze injury data and collate prevention measures in their regions. results: the national timeloss injury rate declined from . to . injuries per personyears since . musculoskeletal injuries consistently comprised the majority of timeloss claims. needlestick injuries, infectious diseases and stress-related claims infrequently resulted in timeloss claims although they are known to cause great concern in the workplace. prevention measures taken in the various provinces related to safer equipment (lifts and electric beds), return-to-work programs, and violence prevention initiatives. different eligibility criteria as well as adjudication policies confounded the comparison of injury rates across provinces. discussion: since , all provinces experienced healthcare restructuring and increased workload in an aging workforce. despite these increased risks, injury rates have decreased. attribution for these trends is complex, but there is reason to believe that focus on prevention can further decrease injuries. while occupational health is a provincial jurisdiction, harmonizing data in addition to sharing data on successful prevention measures and best practices may improve workplace conditions and thereby further reduce injury rates for higher risk healthcare sector occupations. h ealthcare workers (hcws) have greater risk of workplace injuries and mental health problems than many occupational groups in canada; nursing personnel also have considerably more sick time than personnel in most other occupations. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] in , the timeloss injury rate for all hcws was . injuries per person-years compared to . for all bc industries. similar to other jurisdictions, disaggregating the long-term care (ltc) occupations from all hcw occupations revealed that nursing aides had very high injury rates ( . per person-years), with registered nurses also having higher than average rates ( . per person-years). this article provides an overview of trends in workplace injuries and prevention measures in the healthcare sector across canada. reviews note that hcws face substantial occupational risks from exposure to poor ergonomics associated with patient care; patient violence; and exposure to allergens and infectious agents. for example, it is well established that musculoskeletal injuries (msi) occur due to equipment and environmental inadequacies, high work demands, inadequate staffing, poor work morale and low social support. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] nursing personnel report msi prevalence as high as % for upper-body and % for lower-body symptoms. [ ] [ ] [ ] [ ] [ ] [ ] [ ] psychological distress has been linked to patient violence/aggression, [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] high workload [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] and stress. skin and respiratory disorders are concerns due to exposure to irritants as well as a large variety of substances known to cause skin or respiratory sensitization. [ ] [ ] [ ] [ ] [ ] [ ] infectious diseases including tuberculosis, influenza, severe acute respiratory syndrome (sars), hiv and hepatitis are also of concern. - creating "healthy workplaces" to support worker well-being, retain personnel, and ultimately ensure high-quality patient care is therefore increasingly being promoted. [ ] [ ] [ ] [ ] [ ] [ ] health canada commissioned this study to obtain an overview of trends in workers' compensation claims and provincial-level prevention initiatives in order to gain insight into successful strategies for improving working conditions in healthcare. the occupational health and safety agency for healthcare (ohsah) in bc coordinated all data collection and analysis with partner occupational health and safety provincial associations in each respective region (see acknowledgement section). timeloss injury and occupational disease data for - were collected from the national work injuries statistics program (nwisp) compiled by the association of workers' compensation boards of canada (awcbc). labour force data from statistics canada were used to determine workforce size for each province and to calculate provincial injury rates expressed per person-years. healthcare labour force data from statistics canada's socio-economic database were only available by two occupational groupings. injury rate determinations were limited to: "healthcare professionals" and "technical, assisting and other related occupations". where applicable, injury 'frequency' analyses were provided from nwisp data for the three occupational groupings defined by the standard occupation code (soc ), "nurse supervisors and registered nurses", "other technical occupations in healthcare", and "assisting occupations in support of healthcare". collaborating agencies in the provinces provided a chronology of regulatory changes and prevention measures implemented in each province in their region. during - , injury rates in healthcare across provinces ranged from . (table i) . injury rate reductions may indeed be attributable to prevention programs, whether initiated from government or from within the sector itself, but injury rates are also influenced by socio-economic factors including labour relations issues and adjudicative policy trends. ontario's time-loss injury rate trends may suggest the impact of prevention measures ( figure ) . similarly, bc's positive results seem to be at least partially attributable to the formation of ohsah, a bi-partite health and safety agency ( figure ) . while comparison of rates across provinces is problematic due to substantial provincial differences in coding, reporting, and adjudication criteria for timeloss claims, there are major injury rate differences across occupational groups in all provinces (see figure for definitions). the "healthcare professionals" injury rate is almost half that of the "technical, assisting and others". injury frequency patterns for these "assisting occupations" show that ontario, bc and quebec all saw steady declines in injuries from to , with injuries for ontario and bc levelling off, but injuries for quebec beginning to rise again each year after . all other provinces recorded relatively stable injuries per year from to . each province experienced modest yearly fluctuations in rates, but alberta saw a dramatic increase from almost no injuries in and for rns, to more than reported injuries per year thereafter. musculoskeletal injuries (msi) consistently comprised the majority of timeloss claims in each province. from to , saskatchewan, prince edward island (pei) and bc had average msi rates above . injuries per person-years; manitoba, newfoundland/labrador, quebec and nova scotia had msi rates from . to just above . ; and alberta, ontario and new brunswick had msi rates at . or below. the multiplicity of different msi codes confounds the comparison of msi rates across provinces, making detailed comparisons very difficult. for example, bc and alberta disaggregate msis according to connective tissue diseases (noi code ) and traumatic injuries to muscles, tendons, ligaments and joints (noi code ), carpal tunnel syndrome (code ) and back pain (code ). in quebec, back pain is underestimated with awcbc data because many * the labour force survey (lfs) data for this project were a -month average of the total number of hours usually worked by all employed persons in the lfs reference weeks. in order to annualize the size of the workforce, the total weekly hours was multiplied by (weeks in the year). this report used , hours as the yearly equivalent of productive hours. ** injury rate is reported as injuries per person-years. provincial injury rates ( ) ( ) ( ) ( ) ( ) ( ) ( ) source: awcbc and cansim cases are coded as 'sprains' without indicating the part of body affected. violence-related injury is an emerging concern (as much as . incidents per person-years) although most of these injuries do not result in timeloss (less than . claims per person-years). the most prevalent injury in this category consists of 'surface wounds' such as abrasions and bruises. the majority of provinces, with the exception of pei, bc and manitoba, experienced minimal changes in the rate of violence-related injuries (timeloss and non-timeloss) from to . access to "no timeloss" claims data in every province is necessary to provide a better indication of the overall severity of this issue. pei went from having the lowest reported provincial violence frequency rate in and to the highest from through . there is wide inconsistency among provincial wcbs in categorizing infectious disease claims, and this category comprises only a small proportion of all timeloss claims. provincial rates ranged from . to . timeloss claims per personyears. infectious diseases claims are rarely filed although they are associated with stress, especially within the context of sars and hiv. puncture wounds as a proxy for needlestick injuries ranged from less than . to . claims per person-years across provinces for - . research on this subject indicates that needlestick incidents are largely under-reported, yet are an ongoing concern for healthcare workers. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] the low rate reflects the fact that needlestick injuries do not generally result in accepted timeloss claims; in addition, coding may be problematic. with regard to accepted stress, anxiety, and other mental disorder timeloss claims, only bc, ontario, quebec and alberta had sufficient data to comment on trends. most wcbs only recognize mental health claims that occur following a traumatic event (i.e., post-traumatic stress). quebec and bc reported a substantially higher claim rate than the other two provinces. in ontario, % of all stress-related claims were related to violence, with a steady increase in post-traumatic stress from to . quebec saw a steady reduction in stress, anxiety and mental disorder claims from . to less than . claims per person-years during the same time period. the most common prevention measures implemented across provinces were related to safer equipment (such as lifts and electric beds), msi prevention programs, return-to-work programs, and violence year prevention programs. with the implementation of these programs, many provinces reported an initial drop in injury frequency, for example in ontario around - with a gradual increase thereafter (see figure ). collaborating agencies in all regions reported that since , each province has experienced an increased prevalence of factors that are known to contribute to risk of injury, including healthcare restructuring and increased workload in an aging workforce. , , [ ] [ ] [ ] [ ] , , , this suggests that while there has been an increased focus on prevention and safety programs, the impact of these efforts may have been undermined by increased risks within the healthcare sector. it is likely that injury rates would have increased substantially rather than decreasing marginally, as was the case from to , had it not been for the emphasis on prevention. however, we do not have data to substantiate this hypothesis. there are different eligibility criteria, adjudication policies and practices across the country that affect the likelihood of a claim being accepted or even reported. for example, acceptance of repetitive strain injuries (rsi) is inconsistent. there are also different rules concerning when an injury "counts" as a timeloss injury. for example, the waiting period before compensation may vary from: days in new brunswick; an average of days in nova scotia; and the following day in newfoundland/labrador, quebec and ontario. levels of compensation payments also differ across provinces, which may influence the incentive to submit claims. these factors preclude the reliability of any conclusions comparing rates across provinces. available data were not disaggregated to the level of specific occupations and inter-provincial comparisons of occupational groups proved problematic since the occupational mix within the broad categories varies among provinces. msis comprise the majority of healthcare sector timeloss claims in every province, primarily occurring during direct patient care activities. while many strategies have been implemented to specifically target patient/resident care issues, msi risks are still prevalent and still require attention. needlestick injuries and infectious diseases make up only a small proportion of timeloss claims. however, studies have shown that even before the sars outbreak, exposure to infectious agents, including bloodborne pathogens, was associated with anxiety from fear of contracting a fatal disease. [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] the very serious risks of infectious diseases must not be disregarded because of the scarcity of timeloss claims due to these conditions. mental stress also accounts for very few timeloss claims, even though numerous national surveys and studies suggest that burnout and mental stress are increasing problems in healthcare. the paucity of mental health timeloss claims undoubtedly relates to criteria governing acceptance of such claims. injury and illness rates vary considerably within the healthcare sector by province, occupational group, and injury/illness type. cross-provincial comparisons are confounded not only by different adjudicative policies but by different coding practices. the harmonization of workers' compensation data would facilitate the evaluation of prevention measures for reducing workplace injuries and improving working conditions. labour force data disaggregated by occupational category is especially important to facilitate injury analyses since risks differ for occupations within large groupings (e.g., rns and physicians are in the same group yet their risks differ widely). injury tracking would be more feasible if wcb data included: time of incident (enabling analysis by staffing level); type and size of healthcare workplaces (facilitating comparisons); and demographics (enabling the analysis of the impact of an aging work force). sharing data across provinces should be encouraged regarding the effectiveness of programs, policies and interventions that impact positively on reducing injury, illness and disability. there are several successful programs to track injuries (including data collection tools for needlestick, msi and other types of injuries). it is recognized that occupational health and safety is within provincial jurisdiction and each wcb will always have provincial criteria concerning adjudication. cross-sectional surveys (e.g., those proposed by health canada, statistics canada and the canadian institutes for health year information for nursing personnel) would be useful adjuncts, especially in areas such as mental health. ideally, longitudinal studies linking survey data with comprehensive healthcare utilization data and other linked data, would provide the best monitoring tool for the analyses of trends and the effectiveness of interventions. there is growing recognition that the health and safety of hcws needs attention. improved integration of occupational health and safety programs into the orientation and job description of hcws may result in improved work conditions and quality patient care. further research in this area is warranted. résultats : depuis , on a noté un déclin dans le taux de lésions professionnelles (pour travailleurs par année) au niveau national de , a , . les troubles musculosquelettiques constituaient la majorité des réclamations pour jours de travail perdus dans chaque province. les réclamations liées au stress, à des piqûres accidentelles avec des aiguilles et à des maladies infectieuses donnaient peu fréquemment lieu à des jours de travail perdus, bien qu'il s'agisse d'incidents reconnus pour causer d'importantes préoccupations en milieu de travail. les mesures préventives prises par les diverses provinces avaient trait à de l'équipement plus sécuritaire (lèvepersonne et lits électriques), des programmes de retour au travail et des initiatives de prévention de la violence. la différence dans les critères d'admissibilité et la politique d'indemnisation rendait difficile la comparaison des taux de lésions professionnelles entre les provinces. discussion : depuis l'an , toutes les provinces ont connu une restructuration du secteur de la santé et une charge de travail accrue, dans un milieu où la main-d'oeuvre est vieillissante. or, malgré des risques accrus, le taux de lésions professionnelles a diminué. les motifs à l'appui de ces tendances sont complexes, mais tout porte à croire que 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current state of cardiology in china to the editor: i read with interest the recent report that inter-regional cardiac outcome disparities throughout ontario were partially explained by fast-food service intensity. such an association has also been demonstrated in china, especially with regard to hypertension. , zhou et al. showed a close relation between daily urinary sodium excretion and blood pressure in mainland china ( figure ). in general, blood pressure and urinary sodium excretion as a measure of sodium intake tended to be higher in northern china, e.g., beijing (formerly called peking), and shijiazhuang than in southern china, e.g., guangzhou (formerly called canton). of note was the observation that, in guangzhou, a study showed a gradual rise of blood pressure as compared with a study, associated with a corresponding increase in urinary sodium excretion. the increase in sodium intake between these two surveys coincided with the rise in the number of american fast food restaurants, such as mcdonald's and kentucky fried chicken, that had opened in guangzhou during that period. key: cord- -l pvf authors: collins, charles; xu, jing; tang, shenglan title: schistosomiasis control and the health system in p.r. china date: - - journal: infect dis poverty doi: . / - - - sha: doc_id: cord_uid: l pvf over the last sixty years advances have been made in the control of schistosomiasis in p.r. china. there are, however, difficult challenges still to be met. this paper looks at the extent to which the health system offers a positive environment for the control of the disease. it starts by tracing three phases in schistosomiasis control: disease elimination strategy through snail control ( s-early s); morbidity control strategy based on chemotherapy (mid s to ); integrated control strategy ( +). each one of these phases took place in distinct policy-making environments. the paper partly draws on these phases to set out five issues of disease control and discusses them in the context of the health system and its recent trends. these cover the policy-making process, intersectoral action for health, equity and access to health services, funding for public goods and externalities, and strengthening resource management and planning. these issues form the basis of an agenda for integrating research and capacity strengthening in the chinese health system with a view to creating a more positive enabling environment for schistosomiasis control. in so doing it is important to emphasize the role and integrity of the public sector against its commercialization, the underlying value of equity, a systems wide perspective, and the role of advocacy. schistosomiasis japonica is mainly prevalent in people's republic of china (p.r. china), the philippines and small pockets of indonesia, although p.r. china is the most heavily endemic of the three countries [ , ] . a large-scale epidemiological survey at the beginning of s found that the disease was endemic in provinces, one autonomous region and one municipality (city) mainly along the yangtze river in the south of china [ ] . it was estimated that . million people were infected with schistosomes and more than million people were at risk of infection in the s. there were . million infected cattle and the habitat area of oncomelania hupensis, the intermediate host snails of s. japonicum, reached . billion m . a great deal has been achieved in controlling schistosomiasis in p.r. china [ , , ] . between and disease transmission was interrupted in five provinces namely guangdong, shanghai, fujian, guangxi, and zhejiang. by , three provinces -sichuan, yunnan, and jiangsu -reached the criteria of transmission control (both human and livestock prevalence less than %). four other provinces characterized with complicated environments and easily affected by the water level of the yangtze river-hubei, hunan, jiangxi and anhui -reached the criteria of infection control in (both human and livestock prevalence less than %). the number of infected cases has been reduced by over % since the s, reaching the lowest historic level of , infections in [ ] . the area of oncomelania hupensis habitats was estimated to be . billion m which is about % of that in s [ ] . having noted the above achievements, there are still many major challenges such as the existing extensive snail habitats with complicated environments, ecosystem changes caused by the construction of the three gorges dams and the south-north water conversion project, the effects of climate change, the scarcity of a highly sensitive surveillance and response system, and the access of infected persons to health care. this paper analyses the extent to which one of the keys to understand these challenges rests not only in the confines of the schistosomiasis diseases control programme, but in the rest of the health system. how diseases control programmes fit into health systems has been a recurrent theme of health systems analysis for many years. the debate over the vertical and/or horizontal nature of disease control programmes has occupied an important place in health systems analysis, together with discussions over the nature of integration and the specific circumstances in which integration is or is not appropriate [ ] [ ] [ ] [ ] . recent work has also looked to develop a more synergistic interrelationship between disease control programmes and the rest of the health system in addition to a more systems approach [ ] [ ] [ ] [ ] . this paper comes within this line of analysis and focuses on a particular aspect; namely the extent to which the health system as a whole provides a positive environment for the effective development of disease control. it is based on a review of existing research, the analysis of which takes into account the research and practical experience of the authors. following this introduction, the paper identifies the historical phases in the control of schistosomiasis in p.r. china. the phases operated in specific political and social contexts and exhibited particular approaches to disease control. this leads to a consideration of an 'enabling environment' that we judge to significantly further disease control. on this basis, our analysis explores the extent to which the health system does or does not meet the needs of this 'enabling environment'. attention is paid to the policy-making process, intersectoral action for health, equity and access to health services, funding for public goods and services, and strengthening resource management and planning. where appropriate, recommendations for an agenda of health systems research and development will be made. the paper concludes by analysing four emerging themes; the role and integrity of the public sector, the importance of equity for infectious diseases of poverty, the significance of health systems development, and the importance of advocacy. the paper is aimed at researchers, policy-makers and practitioners concerned with both schistosomiasis control and health systems development. it also suggests a line of analysis that can be developed in the analysis of other infectious diseases and their control, such as tb, malaria and hiv/aids. schistosomiasis was one of the serious infectious diseases at the time of the founding of the p.r. china in . many famous terms, such as "village without villagers" "widows villages", and "big-belly village", were used to describe the devastating consequences the disease brought to the chinese people, especially the poor [ ] . since the s china has been fighting the disease; strategies and approaches have evolved in a context of political, socio-economic, technological and epidemiological change. three relatively distinct phases may be identified in the process of disease control: a) s to early s, b) mid- s to about , c) from onwards. in identifying these phases we recognise a degree of generalisation in the analysis together with the overlapping nature of the phases. each phase not only possesses an emphasis on certain approaches to disease control but relates to a policy environment of political and social change. disease elimination strategy with an emphasis on snails control ( s to early s) confronted by the poor state of health in p.r. china and with schistosomiasis as one of the main infectious diseases, there was strong political will among the leaders of the new republic to control the disease. however, the financial and human resources for healthcare in p.r. china were very limited, and most of them were distributed in a few urban cities. the infrastructure of china's health systems in most places was poor and not up to the level of providing appropriate healthcare to the vast majority of the population. however, cooperation among different sectors was developed with programs receiving political support from a high level. in such circumstances, the ministry of health developed a policy of "prevention first" in the s and focused on snail control. snail elimination with environmental modification and mollusciciding was emphasized in combination with chemotherapy. mass movements were developed to mobilize community resources to contribute to the snail control campaign, through free labour, and local-driven innovative models for snail elimination. under the auspices of the communist party, the chinese people, as well as paramedics, such as barefoot doctors at the village level, engaged in disease control programmes. in the meantime, agricultural engineering and water conservancy activities, such as reclaiming wetlands, digging new ditches and filling the old ones, and changing rice paddies into dry crops were developed and implemented as a series of concerted actions to modify the snails' habitats to be unsuitable for living and breeding. an important feature of this disease control was the establishment and the operation of the vertical national schistosomiasis control programme in the s. from national to provincial, prefectoral, county and township levels, anti-schistosomiasis institutions or stations were set up to take the main responsibility for disease control and treatment. the number of staff specialized in prevention and clinical care and working in these specialized organizations reached , by the mid s, a powerful workforce fighting against the disease. the national programme, including these institutes and stations, was relatively well funded until the late s. as results of the effective interventions, a large number of places in p.r. china were free of snails. the prevalence rate of schistosomiasis and new cases was reduced to a very low level in the early s, particularly in the east coastal areas of china. china launched its economic reform in , transforming its planned economy into a market one. the collective economy, based on the commune system in the rural areas, collapsed. a de facto privatization of agricultural production, named as "household responsibility system" was introduced in - in almost all the townships and villages. chinese society has undergone profound changes since the economic reform. while many of these may be viewed as positive, such as improved living standards, there are important downsides, such as worsening equity and social justice. the diminished collective economy in the rural areas meant that the community-based health insurance schemes, called "cooperative medical scheme", collapsed in over % of townships and counties by the middle of the s. government health facilities received relatively less funding to cover their operational costs, while they were implicitly encouraged to increase service charges to support the provision of health services. the commercialization of healthcare has become widespread and common practice in health facilities in p.r. china while the health policy of "prevention first" has to a large extent been neglected since the economic reform. service providers became interested in generating revenues through service charges and profits from drug sale to cover costs and increase their incomes that were often linked to the level of revenue generation. although the government still gave some support for control of schistosomiasis, but it was limited and could not meet the needs for disease control. even the anti-schistosomiasis institutions and centres were required to generate revenues to cover partial costs of their operations. few health facilities in p.r. china were still interested in engaging in preventive measures to control schistosomiasis, among other diseases. furthermore, the mobilization of community resources for the disease control was no longer easy. free labour was no longer available to tackle snail problems in rural communities, as the township and village leadership no longer had powers to force farmers to work on community projects for free. in addition, intersectoral action for health (iah) became difficult, if not impossible. market mechanisms have now come to dominate production in chinese society, while the political push to promote intersectoral action for health and social development, which was strong in the planned economy, has been greatly weakened. by the late s, some provinces and counties had scaled down the vertical programme and integrated many anti-schistosomiasis stations into general centre for disease control (cdc) systems or other disease prevention institutes. by co-incidence, the who expert consultation committee for schistosomiasis control in adjusted its strategy and objectives for schistosomiasis control from transmission interruption or elimination to morbidity control in developing countries [ , ] . the new strategy focused on changing people's behaviour with an objective to reduce the morbidity and mortality of schistosomiasis, rather than controlling the transmission of schistosomiasis completely; it was convinced that it would be formidably difficult to eliminate or interrupt the transmission of schistosomiasis without an enormous amount of financial investment in developing countries. with the support from the world bank loan ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , the implementation of the strategy, emphasizing chemotherapy treatment of human being and livestock, as the main approach, was initiated in and completed in . different chemotherapy strategies were carried out in different endemic areas: mass chemotherapy was used for the people from endemic areas with a high prevalence and with a history of water contact. for residents and bovine in areas with medium endemicity, the treatment was only given to those with stool egg positive or positives in serological tests. in the area of low endemicity, only children were screened and treated, if diagnosed as positive cases. infected cattle were also given appropriate treatments under the world bank project [ ] . the achievement of the world bank funded project proved that the chemotherapy based strategy could decrease the prevalence of schistosomiasis quickly but that the consolidation task is arduous, as the areas of snail habitats are still large and fluctuated greatly in p.r. china [ ] [ ] [ ] . potential transmission remains considerable in the lake areas. in addition, the drugs for anti-schistosomiasis was free under the world bank project, other costs of healthcare such as drugs for liver protection, were required to pay out of pocket by the patients. in the context of lack of appropriate health insurance schemes put in place, early case detection was often problematic. in a more general sense, access to healthcare in p.r. china was worsening in the s, as seen in a rapid rise of healthcare costs, and increasing financial challenges the health insurance schemes in both urban and rural areas were facing. following the completion of the world bank project, the central government failed to come up with concrete policies supporting sustainable control of schistosomiasis, which leading to the resurgence of the schistosomiasis transmission after the world bank loan project ended [ ] [ ] [ ] . since the late s, the government of p.r. china has increasingly recognized the important role the state should play in developing and strengthening health systems to improve equitable access to healthcare for the vast majority of the population. this responded to the increased inequity in health and healthcare and the resulting discontent among the public. the outbreak of sars in was another alarm signal to the government that public health crises can affect not only health but also economic growth. therefore, strengthening health systems to achieve universal health coverage has been put on the political agenda. a decision on the reestablishment of rural health insurance schemes with financial support from central government in was one of many examples that the government of p.r. china has once again taken health policies seriously. under these circumstances and with the re-emergence of schistosomiasis at the beginning of st century in p.r. china, schistosomiasis control has once again been given a high priority. it was recognised that the chemotherapybased approach could reduce the prevalence/morbidity to a low level rapidly. however, the environment of snail habitats would not change much and the opportunities of reinfection for many at-risk population remained high due to unchanged agricultural production and people's life styles in endemic areas. hence, a new integrated control strategy aimed to interrupt transmission based on reducing the rate of transmission of schistosomiasis infection from cattle and human being to snails has been developed and adopted by the national schistosomiasis control programme. the interventions include agricultural mechanization (to replace the use of cattle), supplying water, sanitation and lavatories/ latrines, providing boats with faecal-matter containers, plus routine chemotherapy, moulluscides and health education [ , ] . these interventions have been made possible, owing to strong political, policy and financial support given to the national schistosomiasis control program in recent years. this forms part of the new health system reform in which increasing equitable access to public health interventions is one of top priorities set out by the government. after several years implementation of the integrated control strategy, positive achievements have been seen. four more provinces have now reached the level of infection control and three have met the targets of transmission control [ ] . compared to the situation in , the number of estimated infected people reduced from , to , . the number of acute cases decreased from , in to only in [ ] . the prevalence rate of infected cattle reduced from . % to % over the period. such results show that political will and appropriate policy on effective strategy on schistosomiasis control are critically important to effective disease control. equally important is the strengthening of overall health systems from national to local level. marketertization of healthcare, particularly public health programmes, would not work, especially in infectious disease control. this section will partly build on section by drawing out and discussing five key issues of schistosomiasis control in p.r. china and how they relate to the health system. it will take into account the current trends in the health system and ask how these affect schistosomiasis control. it will also provide the grounds for recommending key areas of research and capacity development in the health system and in relation to schistosomiasis control. although a vertical form of schistosomiasis disease control programme was set in phase one (see section ), there has been a process of integrating the activities of disease control with the cdc system and the general health services. a first area of research and policy analysis therefore is to analyse the extent of that integration, mapping out how this is expressed in resource generation and allocation, policy-making and planning, resource management, service delivery, and governance. this may be accompanied by an analysis of the determinants and impact of the diverse forms of integration in operation [ ] and how the analysis of the five factors in this section would affect the degree of integration. section raised important issues about policy-making for and the prioritising of schistosomiasis control in p.r. china. it was noted that different strategies of intervention have been used corresponding with the three phases which, in turn, corresponded with different policymaking environments. although the first phase was characterised by depleted national resources, there was strong political will to control the disease; a robust vertical disease control programme was developed along with effective community involvement in transmission control, and intersectoral action for health. the second phase occurred in the context of market reform characterised by health care commercialisation and the loss of intersectoral action for health and community involvement. the phase coincided with a who supported shift to morbidity control through the world bank supported project. the third phase constitutes a reaction to public health crises and the problems of inequity engendered through market reform and health care commercialisation. the priority given to schistosomiasis control and the sustainability of interventions are certainly critical issues. these are important given the severity of the disease but also because it can easily rebound if attention is reduced. section emphasised the differences between the high priority given in the first and third periods and the lesser priority given in the second period. it goes without saying that policy-making operates in an historical context and the three phases clearly confirm this. yet this raises a challenge to policy-making; how to achieve consistency and sustainability to undertake the medium to long term preventive interventions and intersectoral action for health as a form of disease control that goes beyond the shorter term political changes and the periodic form of loan financing. at the same time, the possibility of the disease to rebound requires a more sophisticated process of priority setting that relies primarily on the more immediate indicators of mortality and morbidity. prioritising schistosomiasis control within the broad range of health needs and interventions has to go beyond the spoken and written word of the policy declaration. resource allocation has to give a material backing to the prioritising. neither can this material backing be based on the assumption that regions and localities are able to raise their own funds for diseases control. this is particularly true for areas of central and western china which already receive central subsidies for rural health insurance, among others. schistosomiasis is more prevalent in the poorer regions of china; ross et al. noted that the disease ". . .remains a major problem in the marshland and lake areas of hubei, hunan, anhui, and jiangxi and in some mountainous areas of sichuan and yunnan" [ ] . these are precisely among the regions of china that particularly require such subsidies and central funding. lastly, we need to emphasise that schistosomiasis control requires joint policy-making work across organisational boundaries and systems. policy-making needs to move beyond the confines of the health system, a point we now pick up under the heading of intersectoral action for health. iah is clearly important and comes through strongly as an important requirement of the health system for schistosomiasis control. the headlong imperative of economic growth can lead to growing inequality, poverty and disease burden. the precipitous implementation of water development projects and increased urbanisation has laid the conditions for increasing mortality and morbidity from schistosomiasis in p.r. china. to undercut the social and economic conditions of the disease requires a broad political perspective that puts the disease on the policy agenda, brings the disease control into the broader policy process identifying its social and economic conditions and secures the links between the disease control and health systems development. this was clearly more evident in the first and the third phases outlined in section . in the push for increased mechanisation in agriculture and improved water and sanitation, the health system needs to play its part in breaking the barriers within the health system and between the health and other systems such as agriculture, forestry and water / sanitation. it requires advocacy by actors involved with schistosomiasis control through the generation and presentation of evidence on the social economic conditions of schistosomiasis, policy analysis on the effectiveness and feasibility of interventions, together with networking and building coalitions of support for the control of the disease [ ] . there is a need for this advocacy to be based on the underlying values of effective health interventions through iah and equity. an important constraint on iah in p.r. china is the inward looking commercial practices of government sectors since the economic reform. concerned with revenue growth and surplus generation, little is left for pooling resources and space for working together. while recent years have seen improvements in the central coordination of government actionsthrough the national leading group for schistosomiasis control and the five year plan for schistosomiasis controlthere is a need to monitor and evaluate the effectiveness of these organisational changes in leading to implementation of iah at central, regional and local levels. schistosomiasis is principally a disease of the poor and china is far from being an exception in this respect [ , [ ] [ ] [ ] . this raises a number of important issues: the extent to which there is an overall focus in the health system (and within schistosomiasis control) on equity and the poor, the social determinants of schistosomiasis and the impact the disease has on poverty, and the access to treatment for the poor. those infected may use the schistosomiasis control stations (scs) although many of these have been integrated into the centres of disease control (cdc). treatment for schistosomiasis in these facilities is free at the point of delivery. however, before reaching these facilities, patients often pass through general health facilities (e.g. village health stations). there are certainly financial restrictions to access to these general health facilities for the poor, which can lead to further transmission of the disease mainly among the poor. the problem is that yu et al's study in villages of hunan province in found ". . .both the willingness and the amount that people were willing to pay for treatment were low among villagers in the endemic areas in this region, especially in heavily endemic areas where villagers are most affected and have the lowest ability to pay" [ ] . although many are covered by the diverse forms of government sponsored health insurance in p.r. china, regulations on co-payments and ceilings negatively affect access. linked to this are cases of rent seeking behaviour by providers such as supplier induced demand and mark-ups on medicines. research into treatment of tb patients has also shown a certain lack of interest by general health care providers in referring patients on to the free care at the scss and cdcs, thus helping their own health care facility to reap the financial rewards [ ] . whether this occurs in the case of schistosomiasis needs to be the subject of research. the control of schistosomiasis requires iah, interventions that provide public goods and services together with goods with high externalities. this suggests the importance of appropriate and secure funding for disease control by the state and based on taxes or similar secure revenues [ ] . these forms of disease control are not appropriate to financing and provision through private markets or commercialised public provision. the commercialisation of the health system in recent decades raises critical issues for schistosomiasis control in p.r. china. restrictions and relative decreases in government budget allocations to health facilities, the increased dependence on user fees and insurance payments, the use of staff bonus schemes in health facilities based on treatment, the move from prevention to more revenue earning curative services, and the emergence of supplier induced demand raise serious doubts over the compatibility of schistosomiasis control and commercialisation of the public sector in p.r. china [ ] . in theory, cdc and similar preventive institutions in p.r. china should be fully funded by the government. in reality, however, a vast majority of cdc need to raise some fund through service charges in order to cover partial operational costs and increase bonus payments to their staff. a key issue here is the need to develop general funding mechanisms based on tax bases and centrally or regionally allocated to affected regions to allow for the provision of public goods and preventive interventions required in the control of schistosomiasis. complementing the four previous factors of health systems development, there are a number of key areas in which the management and planning of resources need strengthening. these include surveillance and monitoring, human resource development for both specialist research and development in schistosomiasis control and the training of general health staff in the disease control, and the supply systems for delivering medicines. monitoring the effectiveness of implementing schistosomiasis control is a key challenge. there are two important areas for development: firstly, there is the need to ensure targets met with the delivery of high quality services, and secondly, to ensure efficiency in resource utilisation. another most important issue is how to improve positive synergies of combining the local resources with the fund from the central government. some interventions, such as mollusciciding, chemotherapy of local residents and bovines, and faecal management need appropriate resource pooling to increase the population coverage, while some engineering related interventions, such as agriculture irrigation system modification, altering the crops planting, biogas station should pool resources from different channels in an effective way. the high cost-effectiveness for a specific strategy in the either vertical or integrated control program relies on good resource management. in the current status of p.r. china, it is essential for the national control programme in p.r. china to be part of the push for universal coverage of health care in order to ensure sustainable control of schistosomiasis in p.r. china. the five issues featured in the previous section constitute an agenda for integrated research and capacity strengthening in health systems with a view to schistosomiasis control. applied research should increase our understanding of the health system needs of schistosomiasis control, while development strengthens the capacity of the health system to meet the needs of disease control. in so doing, there are four important considerations. a) an important theme running through this paper is to shift away from the commercialisation of the public sector and move towards strengthening of the role and integrity of the public sector in schistosomiasis disease control. this is apparent in the strengthening of policy-making in government, intersectoral action for health, the importance of equity as a key value, the access to treatment, the provision of public goods and the strengthening of resource management and planning. these need to be broken down into specific measures, such as strengthening surveillance systems, urban and rural health insurance, and funding for public goods and services. b) an underlying value of the whole approach to the control of schistosomiasis is that of equity. on the one hand, this requires a reaffirmation of public service values around health systems based on improved and more equitable health and health care. on the other, it is a disease of poverty, the control of which needs to get to the foundations of that poverty. c) the call for research and development in these five areas should not lead to isolation of specific forms of disease control. many of these features of disease control hold for other diseases. at the same time, care needs to be taken in dealing with these issues in a system wide perspective. for example, setting the priority of schistosomiasis control in policy-making and resource control needs to be seen in the context of general health needs and general health planning. the exercise of health needs identification needs to be done across the full spectrum of infectious disease of poverty and, in fact, the overall health needs of a society. the exercise conducted in this paper needs to be one of many exercises in disease control and in which health systems change is responding to health needs of a population. d) lastly, we return to advocacy. it is anticipated that the discussion of this and other likeminded papers should lead to 'a health systems agenda for schistosomiasis control'. such an agenda needs to coalesce around a coalition of stakeholders; those support of sufferers of the disease, researchers from diverse disciplines, technical experts, politicians, health managers and planners, and service providers. additional file : multilingual abstracts in the six official working languages of the united nations. the global status of schistosomiasis and its control kestens l: human schistosomiasis schistosomiasis control in china the global epidemiological situation of schistosomiasis and new approaches to control and research schistosomiasis control: experiences and lessons from china schistosomiasis endemic status in people's republic of china in a brief introduction to a nation-wide sampling survey on schistosomiasis vertical vs horizontal health programmes in africa: idealism, pragmatism, resources and efficiency delivery of priority health services: searching for synergies within the vertical and versus horizontal debate a code of best practice for disease control programmes to avoid damaging health care services in developing countries the 'diagonal' approach to global fund financing: a cure for the broader malaise of health systems? in maximising positive synergies between health systems and global health initiatives. edited by who. geneva: who; . . who: report on the expert consultation on positive synergies between health systems and global health initiatives. in maximising positive synergies between health systems and global health initiatives disease control and health systems in low-and middle-income countries: enhancing positive interrelation who: systems thinking for health systems strengthening who: world health organization new strategy on schistosomiasis control who: the control of schistosomiasis schistosomiasis control in china: the impact of a -year world bank loan project study on the re-emerging situation of schistosomiasis epidemics in areas already under control and interruption challenges and control strategies in areas of schistosomiasis transmission controlled and interrupted in china the public health significance and control of schistosomiasis in china-then and now epidemiology of schistosomiasis in the people's republic of china schistosomiasis japonica control and research needs re-emerging schistosomiasis in hilly and mountainous areas of sichuan china's new strategy to block schistosoma japonicum transmission: experiences and impact beyond schistosomiasis a strategy to control transmission of schistosoma japonicum in china integration of targeted health interventions into health systems: a conceptual framework for analysis. health policy plan schistosomiasis in the people's republic of china: prospects and challenges for the st century valuing health systems: a framework for low and middle income countries social science implications for control of helminth infections in southeast asia spatial epidemiology in zoonotic parasitic diseases: insights gained at the st international symposium on geospatial health in lijiang prioritizing research for "one health-one world is equity being sacrificed? willingness and ability to pay for schistosomiasis control in china how affordable are tuberculosis diagnosis and treatment in rural china? an analysis from community and tuberculosis patient perspectives market reform: a challenge to public health-the case of schistosomiasis control in china schistosomiasis control and the health system in p.r. china. infectious diseases of poverty we would like to express our sincere appreciation for constructive comments and suggestions on earlier version of the manuscript provided by prof. zhou xiao-nong. abbreviations cdc: centre for disease control; iah: intersectoral action for health; sars: severe acute respiratory syndrome; scs: schistosomiasis control stations; tb: tuberculosis. the authors have no competing interests.authors' contributions cc, the honorary reader at liverpool school of tropical medicine, participated in the initial design of the paper and in its writing, jx did the literature review used to develop the paper and also participated in the writing, and st participated in the initial design of the paper with cc, and drafted some sections of the paper. all authors reviewed and approved the final version. key: cord- -prp l br authors: alang, sirry; pando, cynthia; mcclain, malcolm; batts, hasshan; letcher, abby; hager, janelle; person, taylor; shaw, adama; blake, kwamaine; matthews-alvarado, kevelis title: survey of the health of urban residents: a community-driven assessment of conditions salient to the health of historically excluded populations in the usa date: - - journal: j racial ethn health disparities doi: . /s - - - sha: doc_id: cord_uid: prp l br background: data from the survey of the health of urban residents (shur) identified connections between police brutality and medical mistrust, generating significant media, policy, and research attention. amidst intersecting crises of covid- , racism, and police brutality, this report describes survey development and data collection procedures for the shur. basic procedures: we conducted focus groups with black men, latinxs, and immigrants in allentown, pennsylvania. findings were used to develop and refine measures of conditions salient to the health of urban residents across the country. quota sampling was employed; oversampling people of color and persons whose usual source of care was not a doctor’s office. main findings: non-hispanic whites made up just under two thirds of the sample ( . %, n = ). black/african american respondents accounted for . % of the sample (n = ), while . % (n = ) were latinx. only . % of respondents reported a doctor’s office as their usual source of care. novel measures of population-specific stressors include a range of negative encounters with the police, frequency of these encounters, and respondents’ assessments of whether the encounters were necessary. shur assessed the likelihood of calling the police if there is a problem, worries about incarceration, and cause-specific stressors such as race-related impression management. principal conclusions: shur (n = ) is a useful resource for researchers seeking to address the health implications of experiences not frequently measured by national health surveillance surveys. it includes respondents’ zip codes, presenting the opportunity to connect these data with zip code-level health system, social and economic characteristics that shape health beyond individual factors. one of several overarching goals of the healthy people initiative is to create conditions that promote health and wellbeing for all [ ] . these conditions include social, physical, and economic environments that enable people to stay healthy, and that are grounded in the fundamental principle of health equity. healthy people also seeks to eliminate health disparities by addressing the structural drivers of inequities in health [ , ] . to achieve these goals, we must first identify the social determinants of health that are salient to the experiences of people who are socio-economically or racially marginalized. social determinants of health are the conditions in which people are born, live, age, and work that shape a range of health outcomes including the likelihood of becoming sick, health status, and access to care [ ] . covid- has exposed how inequities in social, economic, and environmental conditions-social determinants-shape inequities in health outcomes [ ] . between health inequities made bare by covid- and outrage over anti-black racism and police brutality that followed the murder of george floyd, understanding how structural racism shapes a range of social and economic conditions that impact the health outcomes of black, indigenous, and latinx communities in the usa is critical. access to care matters for health outcomes [ ] [ ] [ ] . however, given similar access, people who belong to racially marginalized groups and those who are experiencing poverty are less likely to initiate care [ , ] . public hospitals, community health centers or clinics, and safetynet settings are defined by their shared vision to provide care to persons who need it regardless of their ability to pay [ ] . as a result, these facilities are mostly used by people who are socio-economically disadvantagedmajority of whom belong to racial and ethnic minority groups, as well as undocumented persons and immigrants who might experience cost, cultural, language, and other barriers to care [ , ] . one very challenging issue in health disparities research is understanding why in urban areas with safety-net clinics, the prevalence of people with unmet need for health care is still high [ ] [ ] [ ] . mistrust in medical institutions is one cause of unmet need [ , ] . a recent publication using data from the survey of the health of urban residents (shur) identified connections between experiences of police brutality and medical mistrust [ ] . that publication continues to receive significant media, policy, and research attention, and researchers are interested in obtaining access to the data amidst intersecting crises of covid- , racism, and police brutality. in this brief report, we describe the process of developing the shur. the survey assesses experiences of police brutality, as well as a range of health, health care, social and economic characteristics, and experiences of people who live in urbanized areas in the usa based on the census. these are areas with a population of at least , people. we hope that this report will facilitate dissemination and further analyses of the data to inform policies and programs needed for addressing health inequities. survey development conceptualization of the survey came from an ongoing partnership between academic researchers, a federally qualified health center (fqhc), and an equity-driven non-profit that serves as a hub for community leadership, empowerment, and transformation through social engagement. our main project focused on exploring the experiences and dimensions of social exclusion and their effects on health outcomes. academic partners analyzed the existing literature on social exclusion. the non-profit and fqhc partners organized three focus groups in allentown, pennsylvania: the first with latinx populations, the second with black men, and the third with immigrant populations. all partners trained community members who then facilitated the focus groups. for example, a latino man was trained to facilitate the latinx focus group. in these focus groups, we found that participants experienced specific salient stressors that shaped their health outcomes, conditions that were neither regularly captured in our population health surveillance surveys nor were in the broad literature on social determinants of health. using the data from focus groups, academic partners began developing a brief but comprehensive survey that includes these experiences. we worked with our nonprofit and fqhc partners in a process that involved multiple conversations with community members who have a broad range of expertise. they included religious leaders, teachers, students and interns, health care providers, previously incarcerated and justice-involved individuals, and people with multiple chronic conditions, including substance use disorders. university partners searched for any existing instruments consistent with the e xperiences of marginalized communities. community members critiqued some of the existing instruments to ensure that word choices reflected their experiences and co-created new measures. measures novel measures of stressors such as a range of negative encounters with the police and assessments of whether those encounters were necessary were included to assess experiences of police brutality. we conceptualize police brutality not merely as the use of force by a police officer, but police action that dehumanizes the victim, even without conscious intent [ , ] . respondents were provided with the following examples of police actions: police cursed at respondent; police searched, frisked, or patted the respondent; police threatened to arrest the respondent; police handcuffed the respondent; police threatened the respondent with a ticket; police shoved or grabbed the respondent; police hit or kicked the respondent; police used pepper spray or another chemical on the respondent; police used an electroshock weapon such as a stun gun on the respondent, and police pointed a gun at the respondent. for each of these actions, respondents were asked whether it never happened to them, has happened about once or twice in their lives, happens a few times a year, about once a month, or happens about weekly. shur also assessed respondents' evaluations of the necessity of the police actions they had experienced. they were asked: "thinking of your most recent experience(s) with the police, would you say the action of the officer was necessary?" our focus group participants contend that individual perceptions of the necessity of police actions are important indicators of the dehumanizing impact of police violence. we also assessed the likelihood of calling the police if there is a problem, worries about potential police brutality, arrest or incarceration, and cause-specific stressors such as race-related impression management, concerns about housing, food, and medical bills. we collected data on reasons for perceived discrimination such as race, language or accent, religion, immigration status, sexual orientation, and gender identity. we also assessed spaces and perpetrators of discrimination-whether discrimination was experienced at work, school, or perpetuated by a health care provider, police or security officer, or an individual in one's neighborhood. other novel measures included in the survey are relational aspects of health care delivery, such as respondents' perceptions of respect during their clinical encounter, and specifically by receptionists, nurses, medical or nursing assistants, and physicians. the survey included three indicators of respondents' sense of social exclusion, feeling like they are not trusted, often feeling left out, and not feeling like a member of a community. we also included existing measures of stressors such as discrimination using the everyday discrimination and the heightened racial vigilance scales [ ] , group-based medical mistrust scale [ ] , and the adverse childhood experiences (aces) module [ ] . we included the following measures of health status: selfrated health, activity limitations (respondent limited in any way in any activities because of physical, mental, or emotional problems), self-rated mental health, and depression and anxiety using the two-item patient health questionnaire [ ] . indicators of access to care include usual source of care, health insurance, perceived unmet need for medical care, perceived unmet need for mental health care, past use of mental health services, and the probability of seeking mental health care. sociodemographic data collected include race, gender identity, sexual orientation, age, marital status, level of education, work status, years in the usa if born outside of the usa, and zip code. the survey instrument was pre-tested among a small subset of community members in allentown (n = ). revisions were made, and the survey was then piloted using a convenient online sample (n = ) with respondents from zip codes across the country, majority being from the east coast. the final version of the survey, after piloting, is presented in appendix . approval from lehigh university's institutional review board was obtained both for the initial social exclusion focus groups and for the survey. the focus groups and survey were funded internally by lehigh university's community-engaged health research fellowship and the faculty innovation grant, respectively. the shur employed quota sampling, a non-probability sampling approach where we looked for specific characteristics of respondents and then obtained a tailored sample that is representative of the population of interest. the target was respondents living in urban areas in the contiguous usa. we assigned quotas for usual source of care and race/ethnicity. black, indigenous, and people color, as well as those who are poor, are more likely to receive care at specific sites rather than from a specific primary care physician with whom they have established a relationship [ ] . having a regular source of care, and the kind of place that people go to for usual care matters for relational aspects of care such as perceived respect and mistrust. given this literature, we assigned a quota for usual source of care. at least half of the sample (n = ) must report a clinic or community health center, an emergency department or urgent care facility as their usual source of care, or report that they did not have a usual source of care. the second quota was specific for race/ethnicity. because we needed respondents, respondents (at least %) must be people of color and no more than % should be non-hispanic white. this falls within the range of the us census and pew center estimates of the racial demographics of urbanized areas and provides enough sample sizes to complete analysis by race/ethnicity. we contracted with qualtrics because their panels are relatively more demographically representative than other online survey platforms for convenience sampling [ ] . qualtrics invited respondents by partnering with over web-based panel providers to access potential respondents based on the specified quotas. respondents received some form of incentive from panel providers, but the specific value of the incentive was not disclosed to researchers. qualtrics monitored the specified quotas using screening questions on race/ethnicity and usual source of care. for example, when enough non-hispanic whites had completed the survey, anyone who identified as non-hispanic white who expressed interest in taking the survey was not redirected to the full survey. this process continued until the quotas were met. a total of persons passed the screeners and met the quota requirements. qualtrics performed quality checks on the data and removed incomplete responses. they also assessed the time it took for respondents to complete the survey. the median time for survey completion was min. respondents who took less than a third of the median time to complete the survey were excluded from the final sample because of the possibility that we provide a brief description of the survey results by select characteristics in table . as shown, non-hispanic whites make up just under two thirds of the sample ( . % , n = ) . b l a c k / a f r i c a n a m e r i c a n respondents constitute . % of the sample (n = ), while . % (n = ) are hispanic/latinx. shur respondents are disproportionately cisgender women ( . %, n = ), and the majority are under the age of ; only . % (n = ) are years of age or older. while slightly more than half of the respondents worked full-time or part-time, three in ten were not in the labor force, and about one in ten were in the labor force but were unemployed and looking for work at the time of the survey. in terms of access to care and health services, most of the respondents had a usual source of care, but they were pretty spread out in terms of the specific places they regularly went to for care. for example, four in ten of the respondents received care from the doctor's office, two in ten at a community clinic, and one in ten at the emergency room. more than a third of the respondents reported unmet need for medical care ( . %, n = ). response options on the -item groupbased medical mistrust index ranged from strongly disagree ( ) to strongly agree ( ) . scores on the medical mistrust scale ranged from to , with higher scores indicating greater mistrust of health institutions. the mean mistrust score for the sample was . . respondents rated if they felt, in general, that they were treated with a great deal of respect and dignity the last time they received healthcare. ratings could range from (no respect at all) to (utmost respect). the range for our sample was to , with a mean of . , and a median of . feeling left out is one indicator of social exclusion. about four in ten respondents agree or strongly agree that they often felt left out. many respondents also reported experiencing salient sources of stress. for example, . % of the sample (n = ) felt hassled, inferior, or discriminated against because of race, accounting for more than half of the respondents who reported any kind of discrimination. almost a quarter of the respondents engaged in race-related impression management-always careful to act in a way that did not consciously live up to the stereotypes of their racial and ethnic groups; . % (n = ) were always worried about being able to pay rent/mortgage/housing costs while . % (n = ) always worried that they would not be able to pay their medical bills if they got sick or had an accident. even though four in ten always or sometimes worried that someone they know would become a victim of police b r u t a l i t y , . % ( n = ) r e p o r t e d h a v i n g experienced at least one of the ten listed negative interactions with the police. the shur is a great resource for researchers and policymakers interested in understanding and addressing factors relevant to the health of marginalized populations. research published using shur data can contribute significantly to ongoing conversations around the connections between police brutality and health, especially access to care and medical mistrust [ ] . nevertheless, there are caveats. first, shur does not employ probability sampling. therefore, estimates from the survey might be ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) sensitive to systematic errors because respondents might differ from non-respondents in significant ways. second, we did not assess respondents' perceptions of the necessity of each negative police encounter. instead, we asked respondents to think about their most recent experiences with the police and to state their perceptions about whether the action(s) of the police were necessary. while we wanted to capture more recent exposures to police brutality, we think that perceptions about the necessity of negative police encounters might be different for different police actions. for example, an individual might perceive the police patting them down before an arrest as necessary and a previous encounter where the police kicked them as unnecessary. these actions have implications especially for assessing mental health correlates of police brutality such as anxiety and depression. despite these limitations, shur can support health disparities research in several ways. first, the survey is informed by the experiences of racialized populationsspecifically black men, latinxs, and immigrants-and assesses salient conditions including sources and spaces of discrimination, social exclusion, experiences of police brutality and stressful anticipations of these experiences, housing-related stress, as well as stress-related to arrests and incarceration. these data can help us identify connections between specific social determinants and a range of indicators of access to care and health status that are included in the data. these connections are important for formulating and implementing targeted policies to address health inequities. second, shur measures relational aspects of care such as mistrust and perceptions of respect that we know are important indicators of the delivery of patient-centered care [ , ] . when patients feel respected, they might then feel supported and empowered to share their own needs, perspectives, and preferences, and therefore engage in shared-decision making [ ] . this might also equalize the inherent power differentials between clinicians and patients, regardless of race and socio-economic status. the data have the potential of helping researchers understand factors that shape relational aspects of care to improve engagement and reduce unmet need. third, shur includes respondents' zip codes. this presents researchers with the rare opportunity to link the data to zip code-level health system characteristics including the availability of physicians, housing characteristics, foreclosure rates, food insecurity, incarceration rates, voting and other indicators of political participation, as well as population-level indicators of structural racism such as black to white ratios in rates of unemployment, poverty, health insurance, and college graduation. these larger structural factors, including structural racism, shape health beyond individual behaviors and attributes [ , ] . therefore, examining their interaction with individual factors in multi-level analyses is critical. in addition, researchers using these data can explore how variation in characteristics of urban areas, including population density, might be associated with variation in a range of experiences and health outcomes. the approach employed in shur-co-creating measures of salient stressors with communities for which our work bears relevance is important for understanding the mechanisms through which social conditions affect health, the contextual specificity of these mechanisms, and what kinds of interventions might help eliminate health disparities caused by structural inequalities. measures in the current survey are critical for providing evidence needed to inform policies that would improve health among urbanized populations. we encourage others to use these data. community-driven approaches to creating measures related to navigating covid- that are salient to the experiences of populations marginalized by structural inequalities are important next steps. office of disease prevention and health promotion rethinking the leading health indicators for healthy people social determinants of health | healthy people . healthy people topics and objectives covid- exacerbating inequalities in the us improving access to care. chang us heal care syst key issues heal serv policy manag access to care for children with emotional/behavioral difficulties changes in selfreported insurance coverage, access to care, and health under the affordable care act uninsured primary care visit disparities under the affordable care act social sources of racial disparities in health america's safety net and health care reformwhat lies ahead? spanishspeaking immigrants' access to safety net providers and translation services across traditional and emerging us destinations national use of safety-net clinics for primary care among adults with non-medicaid insurance in the united states projecting the unmet need and costs for contraception services after the affordable care act for many patients who use large amounts of health care services, the need is intense yet temporary unmet need for medical care and safety net accessibility among birmingham's homeless mistrust of health care organizations is associated with underutilization of health services the functions and limitations of trust in the provision of medical care police brutality and mistrust in medical institutions police brutality and black health: setting the agenda for public health scholars patterns of injustice: police brutality in the courts measuring discrimination resource validation of the group-based medical mistrust scale among urban black men screening for adverse childhood experiences (aces): cautions and suggestions the patient health questionnaire somatic, anxiety, and depressive symptom scales: a systematic review community health centers: providers, patients, and content of care recruiting large online samples in the united states and india: facebook, mechanical turk, and qualtrics respecting patients is associated with more patient-centered communication behaviors in clinical encounters patient trust: is it related to patient-centered behavior of primary care physicians? respect and shared decision making in the clinical encounter, a video-reflexive ethnography structural racism and health inequities in the usa: evidence and interventions investigating neighborhood and area effects on health acknowledgments the authors thank focus group participants, interpreters, and entire staff of promise neighborhoods of the lehigh valley for their work in organizing the focus groups. the data can be accessed by request to the corresponding author.authors' contributions sa conceptualized the research project and lead in the development of the survey and the manuscript. cp and mm assisted in the review of instruments, survey data analysis, and writing. hb and ab were part of the conceptualization of study and assisted with focus group organization. jh, as, and kb collected focus group data and assisted in identifying salient stressors and indicators of exclusion. km assisted in the writing. all authors contributed significantly to this work. all authors take responsibility for the content of the manuscript.funding the focus groups and survey were funded by lehigh university's community-engaged health research fellowship and the faculty innovation grant, respectively. conflict of interest the authors declare that they have no conflict of interests.ethics approval both the focus groups and survey received approval from lehigh university's institutional review board.consent to participate all focus group participants and survey respondents freely consented to participate. code availability stata codes can be accessed by request to the corresponding author. key: cord- -th da bb authors: gardy, jennifer l.; loman, nicholas j. title: towards a genomics-informed, real-time, global pathogen surveillance system date: - - journal: nat rev genet doi: . /nrg. . sha: doc_id: cord_uid: th da bb the recent ebola and zika epidemics demonstrate the need for the continuous surveillance, rapid diagnosis and real-time tracking of emerging infectious diseases. fast, affordable sequencing of pathogen genomes — now a staple of the public health microbiology laboratory in well-resourced settings — can affect each of these areas. coupling genomic diagnostics and epidemiology to innovative digital disease detection platforms raises the possibility of an open, global, digital pathogen surveillance system. when informed by a one health approach, in which human, animal and environmental health are considered together, such a genomics-based system has profound potential to improve public health in settings lacking robust laboratory capacity. supplementary information: the online version of this article (doi: . /nrg. . ) contains supplementary material, which is available to authorized users. in late and early , a lethal haemorrhagic fever spread throughout forested guinea (guinée forestière), undiagnosed for months. by the time it was reported to be ebola, the virus had spread to three countries and was likely past the point at which case-level control measures, such as isolation and infection control, could have contained the nascent outbreak. in , a new dengue-like illness was implicated in a dramatic increase in brazil's microcephaly cases; one year later, analyses revealed that the zika virus had been sweeping through the americas, unnoticed by existing surveillance systems, since late . although public health surveillance systems have evolved to meet the changing needs of our global popu lation, we continue to dramatically underestimate our vulnerability to pathogens, both old and new . indeed, the recent events in west africa and brazil highlight the gaps in existing infectious disease surveillance systems, particularly when dealing with novel pathogens or pathogens whose geographic range has extended into a new region. despite the lessons learned from previous outbreaks , such as the severe acute respiratory syndrome (sars) epidemic in - and the influenza pandemic -particularly the need for enhanced national surveillance and diagnostic capacity -infectious threats continue to surprise and sometimes overwhelm the global health response. the cost of these epidemics demands that we take action: with fewer than , cases, the ebola outbreak ultimately resulted in over , deaths, left nearly , children without parents and caused cumulative gross domestic product losses of more than % . as with prior crises, in the wake of ebola, multiple commissions have offered suggestions for essential reforms , . most focus on systems-level change, such as funding research and development or creating a centralized pandemic preparedness and response agency. however, they also call for enhanced molecular diagnostic and surveillance capacity coupled to data-sharing frameworks. this hints at an emerging paradigm for rapid outbreak response, one that employs new tools for pathogen genome sequencing and epidemiological analysis (fig. ) and that can be deployed anywhere. in this model, portable, in-country genomic diagnostics are targeted to key settings for routine human, animal and environ mental surveillance or rapidly deployed to a setting with a nascent outbreak. within our increasingly digital landscape, wherein a clinical sample can be transformed into a stream of data for rapid analysis and dissemination in a matter of hours, we face a tremendous opportunity to more proactively respond to disease events. however, the potential benefits of such a system are not guaranteed, and many obstacles remain. here, we review recent advances in genomicsinformed outbreak response, including the role of real-time sequencing in both diagnostics and epidemiology. we outline the opportunities for integrating sequencing with the one health and digital epidemiology fields, and we examine the ethical, legal the systematic collection, analysis and dissemination of health-related data to support planning, implementation and evaluation of public health practices and response. outbreaks and epidemics are both defined as increases in the number of cases of a particular disease beyond what is expected in a given setting. in outbreaks, the affected settings are smaller geographic regions; epidemics can span larger areas. clinical metagenomics. with its untargeted approach to sequencing, clinical metagenomics can cross disciplines in a way that clinical microbiology struggles to -identifying viral, bacterial, fungal and other eukaryotic pathogens in a single assay and coupling pathogen detection to pathogen discovery. given the current high cost of the technique -conservatively estimated at several thousand dollars -it is most often used when dealing with potentially lethal infections that fail the conventional diagnostic paradigm, such as the recent diagnosis of an unusual case of meningoencephalitis caused by the amoeboid parasite balamuthia man drillaris or the diagnosis and treatment of neuroleptospirosis in a critically unwell teenager . in the latter case, despite a high index of suspicion for infection, leptospira santa rosai was not detected by culture or pcr, as the diagnostic primer sequences were eventually found to be a poor match to the genome of the pathogen. intravenous antibiotic therapy resulted in rapid recovery. in such an example, the costs are easily justified, particularly when offset against the cost of a stay in an intensive treatment unit. however, routine diagnostic metagenomics is currently limited to a handful of clinical research laboratories worldwide; it is therefore regarded as a 'test of last resort' and kept in reserve for vexing diagnostic conundrums. substantial practical challenges hinder the adoption of metagenomics for diagnostics (fig. ) (reviewed in depth in ref. ) . chief among these is analytic sensitivity, which depends on pathogen factors (for example, genome size, ease of lysis and life cycle); analytic factors (for example, the completeness of reference databases and the potential to mistake a target for a close genetic relative); and sample factors (for example, pathogen abundance within a sample and contaminating background dna). as an example of a problematic sample, during zika surveillance, attempts to perform un targeted metagenomics sequencing on blood yielded few, or in some cases zero, reads owing to low viral titres . targetenrichment technologies (reviewed in ref. ) such as bait probes can be employed, but even these were unsuccessful at recovering whole zika genomes, necessitating pcr enrichment . in addition to sensitivity, universal pathogen detection through clinical metagenomics is complicated by specificity issues arising from misclassification or contaminated reagents, the challenge of reproducing results from a complex clinical workflow, nucleic acid stability under varying assay conditions, ever-changing bioinformatics workflows and cost. given these issues, could metagenomics replace conventional microbiological and molecular tests for infection? recent studies have used metagenomics in common presentations, including sepsis , pneumonia , urinary tract infections and eye infections . these have generally yielded promising results, albeit typically at a lower sensitivity than conventional tests and at a much greater cost. despite these problems, two factors will drive sequencing to eventually become routine clinical practice. first, the ever-decreasing cost of sequencing coupled with the potential for cost savings achieved by using a single diagnostic modality versus tens or hundreds of different diagnostic assays -each potentially requiring specific instrumentation, reagents, validation and labour -is attractive from a laboratory operations perspective. second, and perhaps most compelling, is the additional information afforded by genomics, including the ability to predict virulence or drug resistance phenotypes, the ability to detect polymicrobial infections and phylogenetic reconstruction for outbreak analysis. novel technologies: portable sequencing. given that outbreaks of emerging infectious diseases (eids) most often occur in settings with minimal laboratory capacity, where routine culture and bench-top sequencing are simply not feasible, the need for a portable diagnostic platform capable of in situ clinical metagenomics and outbreak surveillance is evident. a trend towards smaller and less expensive bench-top sequencing instruments was seen with the genome sequencer junior system (which has since been discontinued), the ion torrent personal genome machine (pgm) system and the illumina miseq system, which were released in close succession . each of these instruments costs <$ , and puts ngs capability into the hands of smaller laboratories, including clinical settings. in , the minion from oxford nanopore technologies was released to early access users , heralding the potential nature reviews | genetics outbreak response portable genome sequencing digital epidemiology one health figure | a genomics-informed surveillance and outbreak response model. portable genome sequencing technology and digital epidemiology platforms form the foundation for both real-time pathogen and disease surveillance systems and outbreak response efforts, all of which exist within the one health context, in which surveillance, outbreak detection and response span the human, animal and environmental health domains. the event through which a pathogen is transferred from one entity to another. transmission can be person-to-person, as in the case of ebola, vector-to-person, as with zika, or environment-to-person via routes including food, water and contact with a contaminated object or surface. the use of genome sequencing to understand infectious disease transmission and epidemiology. see fig. . for highly portable 'lab-in-a-suitcase' sequencing. the minion is pocket-sized and is controlled and powered through a laptop usb connection. it is provided under a model whereby the hardware is free but the consumer pays a premium for the reagent and flow cell consumables. compared with bench-top instruments, the absence of a rolling service contract or regular engineer visits makes it theoretically possible to scale this platform out to potentially unlimited numbers of labora tories. importantly, the minion has been used in field situations, including in diagnostic tent labora tories during the ebola epidemic , and in a roving busbased mobile laboratory in brazil as part of the zibra project , . others have taken the minion to more extreme environments where even the smallest traditional bench-top sequencer could not go, including the arctic and antarctic , a deep mine and zero gravity aboard the reduced-gravity aircraft (nicknamed the 'vomit comet') and the international space station . however, this technology is not yet a panacea; remaining challenges include high dna or rna input requirements (currently hundreds of nanograms), which often necessitate pcr-based amplification approaches; a flow cell cost of $ , keeping the cost per sample high despite multiplexing approaches; and high error rates, which require that genomes are sequenced to high coverage for single nucleotide polymorphism-based analysis and analysed at the signal level. moreover, although the long reads produced by the minion overcome a number of challenges in assembling eukaryotic microbial pathogen genomes, such as the presence of discrete chromosomes or long repetitive regions, the upstream nucleic acid extraction steps required to obtain genomic dna vary across microbial domains and might necessitate reagents and equipment far less portable than the minion. from transmission to epidemic dynamics. genomics is capable of informing not just pathogen diagnostics but also epidemiology. pathogen sequencing has been used for decades to understand transmission in viral outbreaks, from early studies of hantavirus in the united states of america to human immunodeficiency virus (hiv) in the united kingdom ; more recently, the approach has been successfully extended to include bacterial pathogens (reviewed in ref. ) and has come to be known as genomic epidemiology, a term encompassing everything from population dynamics to the reconstruction of individual transmission events within outbreaks . most transmission-focused investigations to date have been retrospective, with only a subset unfolding in real time, as cases are diagnosed [ ] [ ] [ ] [ ] [ ] . in transmission-focused investigations, genetic variants are used to identify person-to-person transmission figure | challenges to in-field clinical metagenomics for rapid diagnosis and outbreak response. a mobile medical unit deploying a portable clinical metagenomics platform has been established at the epicentre of an infectious disease outbreak, but the team faces challenges throughout the diagnostic process and epidemiological response. for example, in the case of zika virus, samples, such as blood, with low viral titres, a small genome of < kb and transient viraemia combine to complicate detection of viral nucleic acid by use of a strictly metagenomic approach. furthermore, obtaining a sufficient amount of viral nucleic acids for genome sequencing beyond simple diagnostics requires a tiling pcr and amplicon sequencing approach . other challenges include, for example, access to a reliable internet connection, the ability to collect sample metadata and translating genomic findings into real-time, actionable recommendations. the average number of secondary cases of an infectious disease produced by a single infectious case, given a completely susceptible population. a term describing infectious diseases that typically exist in an animal reservoir but that can be transmitted to humans. the transmission of an infectious disease, such as ebola, from a survivor of that disease who has recovered from their symptoms. a term describing infectious diseases that are transmitted to humans through contact with a non-human species, particularly those diseases spread through insect bites. an example is the zika virus, which is carried by mosquitos. geographical settings where a variety of factors converge to create the social and environmental conditions that promote disease transmission. the process by which an infectious disease changes from existing exclusively in animals to being able to infect, then transmit between, humans. see fig. . events (fig. ) , either through manual interpretation of the variants shared between outbreak cases or via modelbased approaches , with the result being a transmission network. epidemic investigations are very different -only a subset of the epidemic cases are sequenced. thus, the goal is to use the population structure of the pathogen to understand the overall dynamics of the epidemic. here, phylodynamic approaches are used to infer epidemiological parameters of interest. first conceptualized in by grenfell et al. as a union of "immunodynamics, epidemiology, and evolutionary biology" (ref. ), phylodynamics captures both epidemiological and evolutionary information from measurably evolving pathogens -those viruses and bacteria for which high mutation rates and/or a range of sampling dates contribute to a meaningful amount of genetic variation between sequences , -in other words, enough genetic diversity to be able to infer an evolutionary history for a pathogen of interest, even if that history is only over the short time frame of an outbreak or epidemic. this is possible for most pathogens, particularly single-stranded dna viruses, rna viruses and many bacterial species , , but there are certain species for which the lack of a strict molecular clock and/or frequent recombination complicate both phylodynamics studies and attempts to infer transmission events . phylodynamics relies on tools such as bayesian evolutionary analysis sampling trees (beast) , in which sequence data are used to build a time-labelled phylogenetic tree using a specific evolutionary process as a guide -often variations on a theme of coalescent theory . from the tree, one can infer epidemiological parameters, including the basic reproductive number r (ref. ). while the insights that can be gained from genomic data alone are exciting, the utility of phylodynamic approaches is greatly extended when additional data are integrated into the models (reviewed in ref. ). genomic epidemiology in action: ebola. the many genomic epidemiology studies from the ebola outbreak (reviewed in ref. ) used bench-top and portable sequencing platforms to reveal outbreak-level events and epidemic-level trends. real-time analyses published around the peak of the epidemic suggested the following: the outbreak probably arose from a single introduction into humans and not repeated zoonotic introductions , ; sexual transmission had a previously unrecognized role in maintaining transmission chains ; and survivor transmission -another un recognized phenomenon -contributed to disease flare-ups later in the outbreak . the first sequencing efforts, all of which had an effect on the epidemiological response in real time, unfolded months into the epidemic. had they been deployed earlier, we can only speculate as to their potential impact. arguably, the most compelling use of early sequencing would have been to provide a definitive ebola diagnosis in this previously unaffected region of west africa. however, even after the outbreak was underway, sequencing could have benefited the public health response. for example, ruling out bush meat as a source of repeated viral introductions could have changed public health messaging campaigns from avoiding bush meat to the importance of hygiene and safe funeral practices , potentially averting some cases. portable sequencing and phylodynamic approaches are currently being deployed in the ongoing zika epidemic; whether the real-time reporting of genomic findings is able to alter the course of a vector-borne epidemic remains to be seen. retrospective phylodynamic investigations are also useful for pandemic preparedness planning. a recent analysis of , ebola virus genomes -approximately % of all cases -reconstructs the movement of the virus across west africa and reveals drivers for its spread . the authors deduce that ebola importation was more likely to occur between regions of a country than across international borders and that both population size and distance to a nearby large urban centre were associated with local expansion of the virus. these findings may affect decision-making around border closures in future ebola outbreaks and point to the need to develop surveillance, diagnostic and treatment capacity in urban centres. the role of the environment in deploying genomics for surveillance, diagnostics and epidemiological investigation, a key question remains: where? many regions lack the diagnostic laboratory capacity to carry out basic surveillance, but continuous genomic surveillance in all of these settings would be impossible. numerous projects have attempted to describe the pool of geographic hot spots and candidate pathogens from which the next epidemic or pandemic will arise. determining these factors is key to predicting and preventing spillover events (fig. ) ). they report an increasing number of events each decade, generally located in hot spots defined by specific environmental, ecological and socio-economic characteristics. most eids are zoonotic in origin, with the highest risk of spillover in regions with high wildlife diversity that have experienced recent demographic change and/or recent increases in farming activity . a global biogeographic analysis of human infectious disease further supports the use of biodiversity as a proxy for eid hot spots , and reviews focused on systems-level, rather than ecological, factors identify the breakdown of local public health systems as drivers of outbreaks, suggesting that surveillance ought to be targeted to settings where bio diversity and changing demographics meet inadequate sanitation and hygiene, lack of a public health infra structure for deliver ing interventions and no or limited resources for control of zoonoses and vector-borne diseases . these analyses provide a shortlist of regions, including parts of eastern and southeastern asia, india and equatorial africa, on which genomic and other surveillance activities should be focused , . within these regions, sewer systems and wastewater treatment plants could be important foci for sample collection, providing a single point of entry to biological readouts from an entire community. indeed, proof-of-concept metagenomics studies have revealed the presence of antibiotic resistance genes , human-specific viruses . most were zoonotic in origin, and over one-quarter had been detected in non-human species many years before being identified as human pathogens. a later review reiterates this observation, noting that recent agents of concern -ebola, zika and chikungunya -had been identified decades before they achieved pandemic magnitude . as a result of ngs technology, the pace of novel virus discovery is accelerating, with recent large-scale studies revealing new viruses sampled from macaque faeces in a single geographic location and , new viruses discovered from rna transcriptomic analyses of multiple invertebrate species . however, understanding which of these new entities might pose a threat requires a new approach. one health. the emergence of a zoonotic pathogen proceeds in stages (fig. ) ; in an effort to better anticipate these transitions and more proactively respond to emerging threats, the one health movement was launched in . recognizing that human, domestic animal and wildlife health and disease are linked to each other and that changing land-use patterns contribute to disease spread, one health aims to develop systems-minded, forward-thinking approaches to disease surveillance, control and prevention . by investing in infrastructure for human and animal health surveillance, committing to timely information sharing and establishing collaborations across multiple sectors and disciplines, the goal of the one health community is an integrated system incorporating human, animal and environmental surveillance -a goal in which genomics can have an important role. the one health approach has been implemented through the predict project, which is part of the emerging pandemic threats (ept) programme of the us agency for international development (usaid). predict explores the spillover of selected viral zoonoses from particular wildlife taxa , and early efforts have focused on developing non-invasive sampling techniques for wildlife , estimating the breadth of mammalian viral diversity across nine viral families and at least , undiscovered species and demonstrating that viral community diversity is at least a partially deterministic process, suggesting that forecasting community changes, which potentially signal spillover, is a possibility . although the goal of using integrated surveillance information to predict an outbreak is still many years away, one health studies are already leveraging the tools and techniques of genomic epidemiology to understand current outbreaks. combining genomic data with data streams from enhanced one health surveillance platforms presents an opportunity to detect the population expansions nature reviews | genetics figure | inferring transmission events from genomic data. genomic approaches to identifying transmission events typically involve four steps. in the first step, outbreak isolates, and often non-outbreak control isolates, are sequenced and their genomes either assembled de novo or mapped against a reference genome. next, the genomic differences between the sequences are identified -depending on the pathogen and the scale of the outbreak, these may include features such as genetic variants, insertions and deletions or the presence or absence of specific genes or mobile genetic elements. in the third step, these features are examined to infer the relationships between the isolates from whence they came -a variant common to a subset of isolates, for example, suggests that those cases are epidemiologically linked. finally, the genomic evidence for epidemiological linkages is reviewed in the context of known epidemiological information, such as social contact between two cases or a common location or other exposure. recently, automated methods for inferring potential epidemiological linkages from genomic data alone have been developed, greatly facilitating large-scale genomic epidemiological investigations . and/or cross-species transmissions that may precede a human health event. for example, genome sequences from a raccoon-associated variant of rabies virus (rrv), when paired with fine-scale geographic information and data from canadian and us wildlife rabies vaccination programmes, demonstrated that multiple cross-border incursions were responsible for the expansion of rrv into canada and sustained outbreaks in several provinces ; this finding led to renewed concern about and action against rabies on the part of public health authorities . one of the first studies coupling detailed wildlife and livestock movement data with phylodynamic analysis of a bacterial pathogen revealed that crossspecies jumps from an elk reservoir were the source of increasing rates of brucella abortus infections in nearby livestock ; as the most common zoonosis of humans, brucellosis control programmes will benefit substantially from this sort of one health approach . this model, in which diagnostic testing in reference laboratories triggers genomic follow-up, represents an effective near-term solution for integrating genomics into one health surveillance efforts as the community explores solutions to the many challenges facing in situ clinical metagenomics surveillance of animal populations (reviewed in ref. ). initial forays into this area have been successful; for example, metagenomics analysis of human diarrhoeal specimens and stools from nearby pigs revealed potential zoonotic transmission of rotavirus . however, metagenomic sequencing across a range of animal species and environments yields more questions than answers. what is an early signal of patho gen emergence versus background microbial noise ? which emerging agents are capable of crossing the species barrier and causing human disease ? what degree of sampling is required to capture potential spillovers ? ultimately, a more efficient use of metagenomics in a one health surveillance strategy might be scanning for zoonotic 'jumps' in selected sentinel human populations rather than a sweeping animal surveillance strategy , with sentinels chosen according to eid hotspot maps and other factors and interesting genomic signals triggering follow-up sequencing in the relevant animal reser voirs. by combining genomic data generated through these targeted surveillance efforts with phylodynamic approaches, it will be possible to take simple presence or absence signals and derive useful epidemiological insights: signals of population expansion; evidence of transmission within and between animal reservoirs and humans; and epidemiological analysis of a pathogen's early expansion. most modern surveillance systems use human, animal, environmental and other data to carry out disease-specific surveillance, in which a single disease is monitored through one or more data streams, such as positive laboratory test results or reportable communicable disease notifications. despite marked advances over the preceding decades, testimony from multiple expert groups has repeatedly emphasized the need for improved surveillance capacity , , including the use of syndromic surveillance, a more pathogen-agnostic approach aimed at early detection of emerging disease , . syndromic surveillance systems might leverage unique data streams such as school or employee absenteeism, grocery store or pharmacy purchases of specific items or calls to a nursing hotline as signals of illness in a population. increasingly, digital streams are being used as an input to these systems, be they participatory epidemiology projects such as flu near you , the automated analysis of trending words or phrases on social media sites, such as twitter , , or internet search queries [ ] [ ] [ ] . this new approach to surveillance is known as digital epidemiology and is also referred to as digital disease detection . in digital epidemiology, information is first retrieved from a range of sources, including digital media, newswires, official reports and crowd sourcing; second, translated and processed, which includes extracting disease events and ensuring reports are not duplicated; third, analysed for trends; and fourth, disseminated to the community through media, including websites, email lists and mobile alerts in spillover, a pathogen previously restricted to animals gradually begins to move into the human population. during stage one (pre-emergence), as a result of changing demographics and/or land use, a pathogen undergoes a population expansion, extends its host range or moves into a new geographic region. during stage two (localized emergence), contact with animals or animal products results in spillover of the pathogen from its natural reservoir(s) into humans but with little to no onward person-to-person transmission. during stage three (pandemic emergence), the pathogen is able to sustain long transmission chains, that is, a series of disease transmission events, such as a sequential series of person-to-person transmissions, and its movement across borders is facilitated by human travel patterns . epidemiology platforms are currently operating , and their flexible nature and cost-effective, real-time reporting make them effective tools for gathering epidemic intelligence, particularly in settings lacking traditional disease surveillance systems. the fields of one health and digital epidemiology are increasingly overlapping. in the predict consortium, the healthmap system and local media surveillance were combined to identify health events in five countries over a -week period . predict also suggested a role for digital epidemiology in not just event detection but also the identification of changing eid drivers. eids are driven by multiple factors, many of which have digital outputs and represent novel sources of surveillance data . for example, human movement can be revealed by mobile phone data or by the patterns of lighted cities at night, hunting data collected by states can reveal interactions between humans and wildlife, and social media and digital news sources can reveal early signals of famine, war and other social unrest. a major challenge is that the number of digital data sets available for each driver varies substantially, from hundreds for surveying land use changes -many based on remote sensing data -to mere handfuls around social inequalities and human susceptibility to infection, with most data biased towards north america and europe. the digital and genomic epidemiology domains are also starting to overlap. in the ebola outbreak, digital epidemiology revealed that drivers of infection risk included settings where households lacked a radio, with high rainfall and with urban land cover , echoing the evidence from a genomic study suggesting that sites at which urban and rural populations mix contribute to disease . during the zika epidemic, majumder et al. used healthmap and google trends to estimate the basic reproductive number r to be . - . ; phylo dynamic estimates from brazilian genomic data gave similar ranges ( . - . ) , indicating that both types of data streams can be leveraged in calculating epi demiological parameters that help shape the public health response. a digital pathogen surveillance era recent reports have called for the integration of genomic data with digital epidemiology streams , . when informed by a one health approach, the epidemiological potential of this digital pathogen surveillance system is profound. imagine parallel networks of portable patho gen sequencers deployed to laboratories and communities in eid hot spots -regions that are traditionally underserved with respect to laboratory and surveillance capacity -and processing samples collected from targeted sentinel wildlife species, insect vectors and humans (fig. ) . samples would be pooled for routine surveillance -either through targeted diagnostics or, if the issue of analytical sensitivity can be overcome, through metagenomics -with a full genomic work-up of individual samples should a pathogenic signal be detected. at the same time, existing internet-based platforms such as healthmap and new local participatory epidemiology efforts would be collecting data to both identify potential hotspot regions and detect eid events, enabling both prospective and rapid-response deployment of additional sequencers. genome sequencing data coupled with rich metadata would then be released in real time to web-based platforms, such as virological for colla borative analysis and nextstrain for analysis and visualization . these sites -already used in the ebola and zika responses -would act as the nexus for a global network of interested parties contributing to real-time phylo dynamic and epidemiological analyses and looking for signals of spillover, pathogen population expansion and sustained human-to-human transmission. results would be immediately shared with the one health frontlineepidemiologists, veterinarians and community health workers -who would then implement evidence-based interventions to mitigate further spread. the pathway to such a reality is not without its roadblocks. apart from technical and implementation challenges, a series of larger concerns surrounds the rollout of genomics-based rapid outbreak response, ranging from the uptake of a new, disruptive technology to effecting systems-level change on a global scale. sequencing-based diagnostics, particularly clinical metagenomics approaches, are still straddling the boundary between research and clinical use. in this realm, uncertainty is a certainty, be it uncertainty inherent to the technology itself or informational uncertainty, such as how accurate, complete and reliable results actually are . early adopters of genomics in the academic domain are used to uncertainty, often acknowledging and appraising it, but routine clinical use requires meeting the evidentiary thresholds mandated by a range of stakeholders, from regulators to the laboratories implementing new sequencing-based tests. decision criteria that influence whether a new genomic test is adopted include the ability of the assay to differentiate pathogens from commensals, the correlation of pathogen presence with disease, the sensitivity and specificity of the test, its reproducibility and robustness across sample types and settings and a cost comparable to that of existing platforms . validation -defining the conditions needed to obtain reliable results from an assay, evaluating the performance of the assay under said conditions and specifying how the results should be interpreted, including outlining limitations -is also critical. much can be learned from the domain of microbial forensics, where sequencing is playing a large part . budowle et al. review validation considerations for ngs , noting that this technology requires validating sample preparation protocols, including extraction, enrichment and library preparation steps, sequencing protocols, and downstream bioinformatics analyses, including alignment and assembly, variant calling, the underlying reference databases and software tools and the interpretation of the data. complete validation of a sequencing assay may not always be possible, particularly for emerging patho gens. therefore, just as the west african ebola virus outbreak triggered a review of the ethical context for trialling new therapeutics and vaccines , the scale-up of ngs in emerging epidemics will engender similar conversations. rather than wait for this to happen, an anticipatory approach is best, outlining the exceptional circumstances under which unvalidated approaches might be used, selecting the appropriate approach and examining the benefits of a potentially untested approach in light of individual and societal interests. if the social landscape surrounding the introduction of a new technology is not considered, prior experience suggests that the road to implementation will be difficult, with hurdles ranging from public mistrust to moratoria on research . the enthusiasm of the scientific community for new technology must not lead to inflated claims of clinical utility and poor downstream decisions around the deployment of that technology. howard et al. outline several principles for successfully integrating genomics into the public health system, and as we pilot digital pathogen surveillance, the community would do well to keep many of them in mind: ensuring that the instruments and processes used are reliable and that reporting is standardized and readily interpretable by end users; that the technology is used to address important health problems; that the advantages of the approach outweigh the disadvantages; and that economic evaluation suggests savings to the health care system and society . it is also important to reconsider the role of the diagnostic reference laboratory in the new genomic landscape. as their mandates expand to include enhanced surveillance and closer collaboration with field epidemiologists, laboratory directors will face new challenges, from managing exploratory work alongside routine clinical care to hiring a new sort of technologist, one with basic genomics and epidemiology training. the ethical, social and legal implications of digital pathogen surveillance are an emerging area of research (reviewed in ref. ). chief among the issues that geller et al. identify is the tension that exists when a new technology has the power to identify a problem but there is limited or no capacity to address the issue. balancing the benefits and harms to both individuals and populations is challenging when the predictive insight offered by a genomic technology is variable -for example, using genomics to identify an individual as a 'super spreader' has important implications for quarantine and isolation, but that label may be predicated on a tenuous prediction. the problem is further compounded by the fact that many infectious disease diagnoses carry with them a certain amount of stigma and that an individual's right to privacy might be superseded by the need to protect the larger population . data sharing and integration. a critical need for successful digital pathogen surveillance is the capacity for rapid, barrier-free data sharing, and arguments for such sharing are frequently rehashed after outbreaks and epidemics. genomic epidemiology was born largely in the academic sphere, with early papers coming from laboratories with nature reviews | genetics in one such region, the syndromic surveillance system reports higher-than-average sales of a common medication used to relieve fever. spatial analysis of the data from the pharmacies in the region suggests that the trend is unique to a particular district; a follow-up geographic information system (gis) analysis using satellite data reveals that this area borders a forest and is increasingly being used for the commercial production of bat guano. an alert is triggered, and the field response team meets with citizens in the area. nasopharyngeal swabs are taken from humans and livestock with fever as well as from guano and bat tissue collected in the area. the samples are immediately analysed using a portable dna sequencer coupled to a smartphone. an app on the phone reports the clinical metagenomic results in real time, revealing that in many of the ill humans and animals, a novel coronavirus makes up the bulk of the microbial nucleic acid fraction. the sequencing data are immediately uploaded to a public repository as they are generated, tagged with metadata about the host, sample type and location and stored according to a pathogen surveillance ontology. the data release triggers an announcement via social media of a novel sequence, and within minutes, interested virologists have created a shared online workspace and open lab notebook to collect their analyses of the new pathogen. extensive histories in microbial genomics and bioinformatics. for this community, open access to genome sequences, software and, more recently, publications has tended to be the rule rather than the exception. indeed, a national research council report described "the culture of genomics" as "unique in its evolution into a global web of tools and information" (ref. ). the same report includes a series of recommendations on access to pathogen genome data, including the statement that "rapid, unrestricted public access to primary genome sequence data, annotations of genome data, genome databases, and internet-based tools for genome analysis should be encouraged" (ref. ). as genomics has moved into the domain of clinical and public health practice, the notion of free and im mediate access to genomic surveillance data has encountered several barriers: the siloing of critical metadata across multiple public health databases with no interoperability; balancing openness and transparency with patient privacy and safety; variable data quality, particularly in resource-limited settings; concerns over data reuse by third parties; a lack of standards and ontologies to capture metadata; and career advancement disincentives to releasing data [ ] [ ] [ ] . despite these challenges, the spirit of open access and open data remains strong in the community, with over public health leaders from around the world recently signing a joint statement on data sharing for public health surveillance . the ebola and zika responses in particular highlight the role of realtime sharing of data and samples, be it through the use of chat groups and a labkey server to disseminate zika data or github to share ebola data . in the wake of ebola, yozwiak et al. and chretien et al. outline additional issues facing data sharing, from differing cultures and academic norms to complicated consent procedures and technical limitations. they note that we as a community must agree on standards and practices promoting cooperation -a conversation that could begin by examining how the global alliance for genomics and health (ga gh) framework for responsible sharing of genomic and health-related data (box ) could be adapted for the digital pathogen surveillance community. the future: the sequencing singularity? transformative change to public and global health is profoundly difficult. complicating the existence of a rapid, open, transparent response is the fact that no matter the setting, there are often conflicting interests at work. in an outbreak scenario, conflict may result from governments wishing to keep an outbreak quiet and/or from the tension between lower-income and middle-income countries with few resources for generating and using data and the researchers or response teams from better-resourced settings . indeed, the conflicting values in outbreak responses meet the definition of a 'wicked' problem, where issues resist simple resolution and span multiple jurisdictions and where each stakeholder has a different perspective on the solution. even the international health regulations (ihr), which ostensibly provide a legal instrument for global health security, fail to effect a basic surveillance and outbreak response. as of the most recent self-reporting, only % of the member countries of the ihr are in compliance, meeting the prescribed minimum public health core capacities . in these settings, digital pathogen surveillance must be within the purview of the larger global health community and its diverse group of non-state actors rather than being solely the responsibility of nations themselves . this raises an important issue: if nations are willing to cede a certain amount of surveillance and diag nostic control box | the global alliance for genomics and health (ga gh) framework for genomic data sharing in the universal declaration of human rights, article outlines the right of every individual "to share in scientific advancement and its benefit". in this spirit, the global alliance for genomics and health (ga gh) data-sharing framework , which covers data donors, producers and users, is guided by the principles of privacy, fairness and non-discrimination and has as its goal the promotion of health and well-being and the fair distribution of benefits arising from genomic research. the core elements of the framework include the following: • transparency: knowing how the data will be handled, accessed and exchanged • accountability: tracking of data access and mechanisms for addressing misuse • engagement: involving citizens and facilitating dialogue and deliberation around the societal implications of data sharing • quality and security: mitigating unauthorized access and implementing an unbiased approach to storing and processing data • privacy, data protection and confidentiality: complying with the relevant regulations at every stage • risk-benefit analysis: weighing benefits (including new knowledge, efficiencies and informed decision making) against risks (including invasion of privacy and breaches of confidentiality), minimizing harm and maximizing benefit at the individual and societal levels • recognition and attribution: ensuring recognition is meaningful to participants, providing due credit to all who shared data and ensuring credit is given for both primary and secondary data use • sustainability: implementing systems for archiving and retrieval • education and training: advancing data sharing, improving data quality, educating people on why data sharing matters, and building capacity • accessibility and dissemination: maximizing accessibility, promoting collaboration and using publication and digital dissemination to share results to the global health community, the notion of reciprocity suggests that they should derive some corresponding local benefit. the 'trickle-down' effects of global genomic surveillance have yet to be fully articulated, but they are likely to be realized first in the zoonotic domain, where global surveillance efforts will feed back into improved animal health at a local level, in turn benefiting local farmers. outbreaks occur at the intersection of risk perception, governance, policy and economics , and outbreak response is often based on political instinct rather than data . building a resilient and responsive public health system is therefore more than just enhancing surveillance and coupling it to novel technology -it is about engagement, trust, cooperation and building local capacity , as well as a focus on pandemic prevention through development rather than pandemic response via disaster relief mechanisms . expert panels convened by harvard and the london school of hygiene and tropical medicine and by the national academy of medicine have called for a central pandemic preparedness and response agency and also underscored the need for deeper partnerships between formal and informal surveillance, epidemiology and academic and public health networks . more recently, evolutionary biologist michael worobey wrote: "systematic pathogen surveillance is within our grasp, but is still undervalued and underfunded relative to the magnitude of the threat" (ref. ). if we are to achieve the sequencing singularity -the moment at which pathogen, environmental and digital data streams are integrated into a global surveillance system -we require a community united behind a vision in which public health and the attendant data belong to the public and behind the idea that we are a better, healthier society when the public is able to access and benefit from the data being collected about us and the pathogens we share the planet with. virus genomes reveal factors that spread and sustained the ebola epidemic zika virus in the americas: early epidemiological and genetic findings this work is the first to leverage genome sequences generated early in the zika outbreak to provide a real-time glimpse into the spread of the virus establishment and cryptic transmission of zika virus in brazil and the americas genomic epidemiology reveals multiple introductions of zika virus into the united states this paper is the first to use a genomic approach to track the entry of zika into the usa our shared vulnerability to dangerous pathogens progress in global surveillance and response capacity years after severe acute respiratory syndrome west african ebola crisis and orphans commission on a global health risk framework for the future. the neglected dimension of global security: a framework to counter infectious disease crises will ebola change the game? ten essential reforms before the next pandemic. the report of the harvard-lshtm independent panel on the global response to ebola application of next generation sequencing in clinical microbiology and infection prevention this report, from the american 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escherichia coli realtime investigation of a legionella pneumophila outbreak using whole genome sequencing a multi-country salmonella enteritidis phage type b outbreak associated with eggs from a german producer: 'near real-time' application of whole genome sequencing and food chain investigations, united kingdom rapid draft sequencing and real-time nanopore sequencing in a hospital outbreak of salmonella implementation of nationwide real-time whole-genome sequencing to enhance listeriosis outbreak detection and investigation a brief primer on genomic epidemiology: lessons learned from mycobacterium tuberculosis genomic infectious disease epidemiology in partially sampled and ongoing outbreaks this paper introduces the concept of phylodynamics, which has since become a key tool in the population genomics and epidemiology toolboxes measurably evolving populations genome-scale rates of evolutionary change in bacteria towards a new paradigm linking virus molecular evolution and 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symptom reporting spanning influenza seasons the reliability of tweets as a supplementary method of seasonal influenza surveillance twitter improves influenza forecasting web queries as a source for syndromic surveillance google trends: a web-based tool for real-time surveillance of disease outbreaks assessing google flu trends performance in the united states during the influenza virus a (h n ) pandemic digital disease detection -harnessing the web for public health surveillance an overview of internet biosurveillance digital disease detection: a systematic review of event-based internet biosurveillance systems healthmap: the development of automated real-time internet surveillance for epidemic intelligence healthmap has become one of the most important digital epidemiology resources evaluation of local media surveillance for improved disease recognition and monitoring in global hotspot regions drivers of emerging infectious disease events as a framework for digital detection 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socioethical implications the ethical introduction of genome-based information and technologies into public health genomics and infectious disease: a call to identify the ethical, legal and social implications for public health and clinical practice us) committee on genomics databases for bioterrorism threat agents. seeking security: pathogens, open access, and genome databases perspectives on data sharing in disease surveillance. chatham house: the royal institute of international affairs overcoming barriers to data sharing in public health: a global perspective big data or bust: realizing the microbial genomics revolution public health surveillance: a call to share data. international association of public health institutes real-time sharing of zika virus data in an interconnected world democratic databases: science on github data sharing: make outbreak research open access make data sharing routine to prepare for public health emergencies best practices for ethical sharing of individual-level health research data from low-and middle-income settings grand challenges in global health governance social and economic aspects of the transmission of pathogenic bacteria between wildlife and food animals: a thematic analysis of published research knowledge epidemiology: molecular mapping of zika spread framework for responsible sharing of genomic and health-related data literature review of zika virus using genomics data to reconstruct transmission trees during disease outbreaks smith foundation for health research programmes. both authors contributed equally to all aspects of the article. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- -um iv pi authors: nash, carol title: doodling as a measure of burnout in healthcare researchers date: - - journal: cult med psychiatry doi: . /s - - - sha: doc_id: cord_uid: um iv pi burnout adversely affects healthcare researchers, their place of employment, and the production of valuable research. it is directly associated with symptoms of depression and anxiety. having an easily employed and reliable measure of depression and anxiety in healthcare researchers is important if burnout is to be diminished. doodling may be one such measure. doodling became a possible indicator based on unexpected outcomes associated with one diverse and voluntary health narrative research group where doodling was introduced. the result, with respect to casual, self-reported levels of depression and anxiety, ranged from researchers expressing low levels of distress to those revealing clinical diagnoses of depression and anxiety. changes to doodling execution and content, and their effect on the doodler—metrics previously unmentioned in the literature—hold promise for evaluating depression and anxiety levels of researchers. maligned in academic settings with increasingly punitive outcomes, doodling should be reassessed as a possible indicator of internal states of distress, dysphoria, depression, and anxiety based on this university of toronto health narratives research group result of doodling. under certain well-defined conditions, variations in doodling may serve as a measure of change in these internal states and, therefore, act as an aid in reducing burnout. the world health organization (who ) officially recognized burnout in (zoppi ) as a negative, job-related psychological state represented by symptoms such as physical fatigue, emotional exhaustion, and loss of motivation (freudenberger ) . adversely affecting healthcare researchers, their place of employment (heinemann and heinemann ) , and the production of valuable research (schaufeli, et al. ) , burnout is directly associated with levels of depression and anxiety (haslam et al. ; hakanen and schaufeli ) . therefore, having an easily employed and reliable measure to identify levels of depression and anxiety in healthcare researchers is important if the incidence of burnout is to be diminished. doodling may be one such measure. since and , respectively, the hamilton anxiety rating scale and the hamilton rating scale for depression have been available as measures for these disorders. however, neither was designed (hamilton (hamilton , for considering the continuum of distress, dysphoria, and depression (tzeses ) that is evident in burnout. in searching for a simple, broadly ranging evaluation tool, doodling-an aimless scrawl made by a person while their mind is otherwise applied (oxford english dictionary)-may hold a key. doodles, it will be shown, hold potential to directly gauge the range of disaffect associated with burnout (pillay ) in a way that other indices do not. the rorschach inkblot test (garb ) and trimble's predesigned pictures of representational doodles (trimble ) currently are available to assess mental states for this purpose. yet, these tools for interpreting the psyche depend on standardized images doodled by someone else. in contrast, the type of doodles proposed here are ones based on the researchers' own spontaneous performance. as such, in being generated spontaneously, doodling differs from considering predetermined drawings. yet, human figure drawing, previously used pervasively to access intellectual ability, is also generated spontaneously and has been found to lack validity (imuta et al. ) . doodles, however, differ from prompted human figure drawing as they are found distinct from drawing to prompts. in the research presented here, it has been discovered that doodles created over a number of sessions, while the researcher is attending to a writing program, may in specific situations reflect accompanying changes in the psyche. it would be an important insight to learn that the changes produced are related to the work-related levels of distress, dysphoria or depression and to the anxiety in efforts to reduce burnout. the discovery of doodling as a possible indicator for the levels of depression and anxiety experienced by healthcare researchers stemmed from noting unexpected outcomes associated with one health narrative research group. since , the university of toronto department of psychiatry has sponsored the weekly health narratives research group (henreg) facilitated by the author through the toronto mount sinai hospital as representative of the university's health, arts and humanities program. the henreg allows researchers the opportunity to take the personally relevant stories that initiated their commitment to healthcare and develop them into narratives with a particular point of view. the process includes both cult med psychiatry personal reflection in response to writing prompts and the willingness to share one's story and gain additional insights from the rest of the group. it is a voluntary, noncredit group open to any member of the university community pursuing healthcare research-one that encourages diversity of membership. over these years, the group's process has aided members to doodle as they listen to the stories of the other participants and wait to pose questions to them. it is the result of these doodles with respect to casual, self-reported levels of distress, depression and anxiety that has been unexpected. changes to the execution and content of these doodles, and changes in the effect they have on the doodler-metrics previously unmentioned in the literature-hold promise for evaluating the depression and anxiety levels of researchers. among educators, the status of doodling is controversial. many would contest the notion that doodling might serve as a valid index of mental states that otherwise are difficult to evaluate. the common currency of educators is that doodlers are unable to concentrate on their work and likely to fail at written work because they doodle. these educators repeat their prejudice against doodling when doodlers appear not to be listening and when examining the written work of doodlers (dicks, et al. ) . students are aware of and internalize educators' extreme prejudice against doodling. in a wikipost composed by contributors, last updated on june , (how to annoy your teachers ), the best ways to annoy your teacher were listeddoodling ranked number -higher than passing notes, or showing up late for class. this perception of doodlers as defiant rule-breakers has led to doodlers in us public school settings being arrested by police on at least three separate occasions for doodling (khalek , gora , croucher . accordingly, learners consider their need to stop doodling as something to master early in their educational careers. doodling, when learners do engage in it, becomes anxiety-provoking for the doodler. the inability to find an acceptable outlet to doodle is both frustrating and a reason to adopt educators' views on doodling uncritically (siebarth ) . the history of peer-reviewed research on doodling began with a study of over doodlers (maclay et al. ) . after a significant gap in publishing on doodling, doodling by nurses was considered (de guzman et al. ) . subsequently, peer-reviewed publications on doodling became more frequent, beginning with the contribution of a test devised and implemented for doodling (andrade ) and a lancet study concerning doodling (schotts ). following these articles, the rate of publication related to doodling increased slowly but steadily from until (chan ; tadayon and afhami ; boggs et al. ; burton and baxter and meade et al. ) . in , the test was replicated (singh and kashyap ) . nevertheless, over the more than eighty years since research began on doodling, these few articles represent the extent of peerreviewed studies on doodling and demonstrate the paucity of publications on this cult med psychiatry topic. moreover, with respect to the information to be reported here, none of these publications has considered doodling as a valid measure of any internal state. one can conclude from maclay et al. that doodling is on a spectrum ranging from merely entertaining to relaxing to something crucial for work-place creativity. as such, how the doodler experiences their doodling makes a difference in whether the act of doodling will be relevant to measuring changes in their psyche. if the doodler considers doodling merely entertaining it is unlikely to reveal internal states. on the other hand, if the doodler feels they are able to relax from doodling, this would seem the ideal condition for an expression of mental states. in other words, the subject's belief in the therapeutic or self-empowering aspects of doodling may be a precondition of the use of doodling as a metric. at the other end of this spectrum, if doodling is essential to the doodler for their creative work then it is unlikely the doodling will demonstrate the workings of the psyche as the doodler will approach doodling with the attitude of a professional rather than that of an amateur. in assuming the attitude of a professional, those for whom doodling is essential for their creative work develop a social psychology of expertise where doodling becomes a reflection of their expertise rather than their current mental states (mieg ; eraut ) . these conditions may thus inform whether doodling has an ability or not to measure levels of depression and anxiety. the supposition is that doodling will not reveal the mental states of those participants who consider doodling either merely entertaining or as essential for their creativity. as such, it is considered that those who find doodling relaxing will be the participants whose psyche will be measurable through doodling. the lack of research on doodling makes current results from the university of toronto group valuable. insights will be offered beginning with the year doodling first became a feature of the health narratives research group (henreg). the aim of presenting these results will be to discover the effect of doodling with respect to a number of variables: members' continuation with the group, how often they doodle, the effect of doodling on their narrative work, their choice of subject and mood they express when doodling, and changes the participants noted regarding self-reported anxiety and depression in relation to doodling-all potentially important parameters with respect to burnout. the progress from to of two doodlers in particular who considered doodling relaxing will be highlighted as examples of those who self-reported changes to their depression and anxiety levels and at the same time there appeared corresponding changes with their doodling. these results will be compared with the doodles of a participant who was merely distressed at the thought of being asked to doodle but, because of the non-judgmental atmosphere of the henreg, was able to relax and doodle. a comparison will also be made with a participant who thought of doodling as merely entertaining and another group member who included doodling as essential for their creativity. in both the latter cases, doodling was unable to measure the internal states of the researchers. it is supposed that it is because doodling did not produce a change in the relaxation level of the doodler-thought to be the key ingredient in revealing internal mental states. the henreg is unique. its purpose is to take each participant's story that initiated their healthcare interest and, with the help of weekly writing prompts, evolve it into a narrative with particular point of view. the intention is to reenergize and sustain career-long research and decrease burnout from research-related anxiety and depression. in this regard, the group is responsive to the philosophy-as-therapy program initiated by wittgenstein ( ) and since undertaken by others, such as crittendon ( ), peterman ( ) , hagberg ( ) , and heaton ( ) , although there are no claims to the group being medical therapy. two of the important features of the group include its diverse membership and the continuous developmental feedback method employed. those who take part in the health narratives research group are researchers willing to consider others their equals. they originate from various university of toronto departments and include students (undergraduate, graduate), faculty, and researchers (staff and alumni) who are seeking a group setting for healthcare research-related introspection. for the most recent year, / , the participants represented the following disciplines: marketing, social work, history of medicine, developmental psychology, economics, socially engaged art, environmental health, education, psychotherapy, neuroscience, immunology and english. the discussion revolves around written responses to -min prompts, provided weekly by the facilitator; the responses are spontaneous and unprepared in advance. when the time is up, participants read their response to other members of the group one by one. the members pose questions to each other to help clarify what the member who is the current focus has written in response to the prompt. the writing prompts follow a particular method over the academic year. the intent is to ask the conceptually simplest, most objective and least anxietyprovoking questions at the beginning and gradually move to those that are more conceptually difficult, subjective and contemplative. a simple, objective question that is unlikely to invoke anxiety is, ''when did you begin your research?'' a conceptually difficult, subjective question that would be more likely to promote anxiety (and is thus asked later in the academic year) is ''why do you continue with your research?'' as such, the order of questions is those beginning with the word ''when, '' then ''where,'' ''who,'' ''what,'' ''how,'' and, finally, ''why.' ' each type of question is asked for at least weeks, with ''how'' and ''why'' questions asked over weeks. while they are listening to a member read their response to the weekly prompt and while they wait their turn to ask a question of the reader, the participants are encouraged to use the readily available art materials to doodle. the doodling is understood to be something extra to do while they wait, and only if they choose. there is no requirement to doodle. the participants do not see their doodling as some kind of formal creation that will be assessed by others-it is entirely unmotivated and internally-driven. the doodles are shared, but only for information, not evaluation. doodling is seen by participants as a way to pass the time while waiting to speak. doodling was initiated following the previous introduction of drawing to prompts at the henreg meetings. drawing to prompts began in the fall of based on the suggestion of one of the group's members. this first year, group members experimented with the various art materials available throughout the academic year in response to the drawing prompts (wu and rau ) . why these drawing prompts were not doodling is that they represented ''art'' produced for external consumption. doodling, in contrast, once introduced, was produced with no intent in mind. the difference in results between drawing and doodling at the henreg meetings will later be made clear. it wasn't until fall that doodling, in addition to drawing to prompts, was added extemporaneously by group members and continued because of participant interest. there was no direction given regarding what to doodle and participants who did doodle chose whatever they wanted to produce. once doodling became an anticipated part of the group process, whether or not a drawing prompt was provided, all members were encouraged to doodle. at the end of every meeting, all drawings and doodles were shared and described; they were not evaluated. members shared and described their work for reasons other than the sake of critique. instead, the purpose of sharing and describing was that the doodlers were genuinely interested to let others know what they had done. there were, in fact, a few instances where the doodler did not want to say anything about their doodle and this was also accepted. it was at these times of sharing that some group members, without prompting or unrelated to the matter under discussion, selfreported that doodling relaxed them, made them feel happier and helped them to concentrate on the responses of other members. as well, it helped them to formulate questions to ask other members about their responses. each week, the doodles (along with the written responses to the -min writing prompt and any drawings done to a drawing prompt) were collected by the facilitator at the end of the meeting, photographed, and then shared-with the comments about the doodles-on the private facebook group established each year by the facilitator for documenting the henreg's academic year. at year end, the facilitator compared the doodles for the entire year with respect to a number of features: willingness to doodle, how doodling affected meeting attendance, doodler's frequency of drawing at meetings, range of subjects chosen and moods expressed, as well the influence doodling had on writing and how the doodles in the second year compared with the first year when only drawing was offered. why these features were chosen for examination related to the interest of the facilitator in retaining membership of the henreg. a lack of willingness to doodle was found relevant to members' intentions to leave the group. as well, members who persisted in particular subjects and moods expressed were more likely to want to continue with these themes at subsequent meetings and, thus, wanted to remain with the group. furthermore, as creative writing was the focus of the group, whether doodling had any effect on the primary purpose of the group was relevant to the interests of the facilitator. additionally, the doodles of two members of the henreg who have been part of the group for a number of years were examined in detail in contrast to a newer member who, unlike the first two, did not express experiencing depression and anxiety. providing further comparison to these two was one member who found doodling merely entertaining and another who saw doodling as an aspect essential to their creative work. the first doodle (as opposed to response to a drawing prompt) produced ( fig. ) was created spontaneously six weeks after the start of the / academic year. after creating the doodle, the researcher who produced it (self-reporting depression and anxiety) disclosed feeling more relaxed and happier. however, when it was suggested they also doodle, those with the greatest seniority as researchers felt inhibited being asked to doodle. and, once they did try to draw, they did not like the result of their efforts and were focused on self-critique rather than acceptance of what they had created. whether it was a contributing factor or not, these more senior researchers who expressed anxiety in relation to doodling did not return to the henreg meetings after their first attempt to doodle (figs. and ). another result of spontaneous doodling was that certain members who had been coming to the group sporadically now began to come regularly (figs. and ). others who had always come regularly began to stay late, after the meeting, to elaborate on their doodles. it was this group in particular who often voiced they felt happier doodling and less anxious (figs. and ). there were four divisions identifiable among the members of the henreg who doodled. the first group were those who never doodle and have not drawn since they were children (fig. ) . the second group were people who used to enjoy drawing but had stopped once they began their academic careers (fig. ) . a third group had kept up their drawing skills but only drew occasionally (fig. ) . the final group were those who drew regularly (fig. ) . it might be objected that these ''doodles'' are not really that at all, but deliberate efforts to create ''art.'' although some of these doodles may look like planned art this is because most often, when people have the chance to doodle in other circumstances, they have very little time to work on their doodle and they are not encouraged to do so. in a setting where participants have h to work on a doodle whenever they want and feel comfortable continuing with their efforts, as they do at the henreg, what may start off as just a squiggle can develop into what looks like a planned creation. however, it was clear from what people said in discussing their work that their creations developed as the time went on during each session and could change from one form to another during the time allotted. it is interesting to note the more regularly the group member drew the less often they would comment on the doodling reducing their depression and anxiety. in other words, regaining a childlike ability to doodle seemed to be an important feature to reports of increased happiness and relaxation (it was these positive sentiments that were voiced rather than their saying per se that they felt less, distressed, depressed or anxious). the range of subjects that the researchers chose depended on their feeling of relaxation at the time the doodle was produced. those who were deeply involved with the content of the written narratives being produced and discussed concurrently were more likely to doodle shapes representing their thinking process during the discussion. for example, one researcher said he began with three different ideas about something and they merged into one (fig. ) . others who thought of the opportunity to draw as a welcomed invitation were more likely to doodle subjects that held personal relevance. these included drawings of space craft (fig. ) , manga faces (fig. ) , animals (fig. ) , dinosaurs (fig. ) , spongebob (fig. ) (fig. ). one participant who revealed he was at the time suffering from anxiety and depression was reluctant to doodle but, when he did, preferred doodling monster faces (fig. ). the moods participants expressed from doodling were ones they acknowledged in comments made while the henreg was in progress. one group member who used to draw regularly as an adolescent remarked how happy doodling made her feel. (figure ) . the next doodle shown was created by a woman who represented herself as extremely pregnant in her doodles. she said she was anxious about the thought of pregnancy (fig. ) . following that was a doodle done by a participant with depression and anxiety who indicated he was feeling depressed that day and this was a mask of himself (fig. ) . the doodle of the pear with orange boots was by the artist in the group who said she felt in awe of this character she had created (fig. ) . the next doodle was by a group member who said he felt he was undergoing quite a lot and felt confused by his reactions (fig. ) . the pathway drawn that is also the trunk of a tree the doodler described as something playful (fig. ) . finally, when another doodler drew an axe he described it as something in him that is very powerful (fig. ) . in each of these description of their doodles, what is interesting is that what was doodled by the researcher had no connection to the concurrent written narrative activities of the group. the moods that arose were ones outside the narrative discussion. as doodling is a peripheral activity of a group focused on writing, it is interesting to consider what effect the introduction of doodling had on the written responses to the prompts at the henreg meetings. when doodling began to be encouraged at the henreg, one of the first type of comments voiced by the participants who were most eager to be invited to doodle was that doodling relaxed them and helped them to be more in touch with their intentions regarding their research. doodling helped those who were reluctant to write spontaneously feel less inhibited to do so. an additional comment made by more than one group member once doodling was added to the henreg activities was that they felt more proficient in writing their responses to the prompt. furthermore, they found the writing experience more enjoyable. participants also sometimes incorporated words into their doodle. there were a number of ways this might occur: to label a part of the doodle (fig. ) , to inspire the viewer (fig. ) , as a component of the doodle (fig. ) , to explain something (fig. ) or to redirect the viewer from the doodle to some other potentially more meaningful concern to the researcher (fig. ). drawing to prompts had been initiated at the henreg during the / academic year. doodling didn't spontaneously arise until the following year and, after that time, doodles were often undertaken as well as or instead of drawing to prompts. it is interesting to compare the difference between drawing to prompts and doodling, suggesting a methodological error in previous research where the subject was only ever told what to doodle. when group members drew to prompts alone, fewer participants were willing to take up drawing, believing that they lacked the skills to draw. those who did agree to draw to the drawing prompts demonstrated in contrast, the following year when doodling was supported and encouraged at the henreg meetings, the doodles produced differed significantly from the drawings of the previous year in the following ways: ideas arising freshly were placed in any available space, smaller drawings were put together randomly, and the focus was on the process of developing pattern details rather than creating a cohesive product (see, for example, figs. , , and ). this demonstrates that doodling is in fact a more or less spontaneous expression of inner psychic states rather than an artistic production contrived for external consumption. what is perhaps most relevant to considering how doodling reflects the psyche of the researchers participating in the henreg is comparing doodles over a period of time. the doodles of two participants who had both expressed depression and fig. example of a doodle using space randomly focused on pattern details rather than cohesiveness fig. example of a doodle using space randomly focused on pattern details rather than cohesiveness fig. example of a doodle using space randomly focused on pattern details rather than cohesiveness cult med psychiatry anxiety will be examined. both began membership at the henreg in the / academic year and have been part of the group each year following. as well, both told the group they were experiencing anxiety and depression related to their research and this was affecting their work. what differs between the two is the way in which their anxiety and depression evolved over the sessions. and what is extraordinary is how their doodles reflected what they had to say about their mental state at the time. it may be that the sessions themselves diminished their depression and anxiety. yet the point is not that doodling causes the reduction in depression and anxiety (although it might in some way), it is that whatever the level of depression and anxiety of the researcher, the doodle reflected how the level changes over the course of the meetings. then we will turn from the researchers who expressed depression and anxiety to examining the doodles of those who did not. when a researcher described herself as nothing more than distressed, doodling was still seen to relax her and this was revealed in her doodle. in contrast, when the researcher was neither depressed nor anxious and saw doodling as merely entertaining, nothing was revealed of her internal state. finally, there was the member who drew regularly and considered doodling a thoughtful practice essential for her development as an artist. as such, her doodles were a professional output rather than an expression of her psyche. let us consider the researcher who came to the group dissatisfied with his current area of research. he had wanted to switch his area of concentration but, until joining the group, he hadn't demonstrated the resolve to do so. as he was making the transition to his preferred area of research, a personal tragedy struck. this affected him significantly, causing worry about the time he believed he was wasting and the need to transform himself soon into who he aspired to be. then, the depression began to lift and he started to feel more relaxed and even playful about his research. this is especially so since he had at this point completed work he considered destined for publication. these transitions in his self-reported mental health were evident in his doodles. initially, when he was depressed and anxious about his research, his doodles were of small, unrelated objects (fig. ) . then, as he transitioned to the new discipline for his research, he began to produce larger doodles (fig. ) . after the personal tragedy, he produced a doodle of those he knew dancing around a black hole (fig. ) . this doodle was notable because never before had he used black in this way on his doodles; nor had he drawn a group of people, or drawn stick figures. the same day, he also drew a page of colorful squiggles (fig. ) . in describing this fig. doodle of small unrelated objects produced when researcher indicated he was depressed cult med psychiatry colorful doodle, he said he had wanted to use the colors but ''wasn't feeling it.'' over the next few meetings, his doodles became focused on space and time (fig. ) . when he initially mentioned that he was starting to feel better, he doodled his first abstract pattern (fig. ) . then, he started to focus on adding color to design (fig. ) . most recently, he has wanted to ''have fun'' blending colors (fig. ) . this desire is represented in his now larger-page doodles that are no longer confined to expressing identifiable content. there was another researcher who was agitated and depressed with his lack of work progress when he joined the henreg. his thinking was complex and pulled together information from a number of disparate disciplines. at the same time, he was researching his own personal limits mentally and physically. for years, he increased the breadth and depth of his research program, then he began to state that he was ''running out of steam.'' after this, the researcher mentioned that things were depressing in his research progress. one session, he arrived late in obvious distress, yet, he persisted at the group meeting until the end. then, he did not attend again for months. once he returned, he began to recover and regain the ability to productively concentrate on his research again. similar to the previous group member, the mental state of this participant was evident in the doodles he produced. initially, these doodles were composed of small parts that were arranged complexly (fig. ) . then, the day came he said he was (fig. ) . as he began to note increasing depression, his doodles became more focused on wanting to expand in more than one location from one point upwards (fig. ) . the session at which he arrived obviously ill (which he confirmed) was the first and only time his doodle involved using heavy black lines (fig. ) . the first doodle he attempted once he returned after his absence included a number of interconnected ideas and colors as well as the use of a new medium (fig. ) . he felt that with this doodle he was beginning to work things out. the henreg member who first joined fall had not drawn since childhood and feared that she could not as a result of being ridiculed for her lack of talent when she as young. her distress related to now being asked to do something she had been told by teachers was wrong for her to do. yet, as a result of art materials being available and the non-judgemental nature of the group, she was able to develop as a doodler because she felt relaxed as part of the group. her first doodle (fig. ) resulted from tracing around her coffee cup and then coloring in the circles she created. at the next session, still anxious about being asked to doodle, she picked up a leaf on her way to the group meeting and then did a rubbing of the leaf for her doodle (fig. ) . the next week, she did not make use of any props to create her doodle; however, she made us of the word ''where,'' which was the type of question beginning the writing prompt for that week (fig. ) . it wasn't until after the facilitator bought new sensually appealing art materials for everyone's use that this participant started to doodle with more freedom. she used the buttery feeling crayons to make spirals (fig. ) . the next week, she went further and stretched her spirals across the page and hinted at a larger, planet-like feature at the bottom portion of her page. (figure ). regarding the last doodle in this series, she said it was because of the henreg that she has decided to become more creative (fig. ) . in comparison with the first three doodlers-whose revelations indicated their being on the spectrum of distress, dysphoria, and depression-the doodles of another member offer an instructive contrast. this member had been with the group from its inception and considers doodling a sideline from the more structured part of the group's activities-the written narratives. she saw doodling as entertaining. there are only two types of doodles this member produced: reproducing what was in front of her, be it objects or people (figs. , , and ) , and carrying out instructions for a procedure (figs. , and ) . in fig. , for example, she started with a wavy line. then, she drew the opposite wavy line on top of it. once she added some colors, she then considered it looked like a caterpillar and decided to make another going the other direction. having room to draw one more caterpillar, she did so, then she drew some dirt around them. this researcher did not appear to be affected by doodling and did not see doodling as additionally relaxing (she already felt relaxed). it can be surmised that in treating doodling as entertaining the doodling was unable to identify any changes to the emotional state of this researcher. the final set of doodles (figs. , , , , and ) was created by the professional artist in the group. her doodles were artistic experiments aided by a familiarity with her skills as an artist and the range of effects she could elicit from the art materials. in seeing doodling as imperative for her creativity, the artist acted as a professional engaging in an aspect of her trade rather than using doodling to reveal her emotional state. it is difficult to see her doodles as a metric. according to the accounts provided by the artist at the time the work was produced, fig. represents thinking about new signage for the walking man and figs. and , part of the practice of the artist in creating comics is a focus on wandering through landscapes and through the urban areas using abstract forms with the aim of developing self-direction in geography. figure was said by the artist to be the ''king frog character who actually acts on all the self-deprecating feelings that others only think about.'' she wasn't sure why she drew him jogging. figure is a character the artist was developing. figure represents three characters of a comic the artist was in the concrete insights have emerged from doodling at the henreg over a number of years. the doodles produced are a reliable indicator of changes in researchers' state of mind regarding their work under certain, well-defined conditions. under the appropriate circumstances, the subjects chosen and the materials used by the participants for their doodles quickly determine whether the researcher is becoming more, or less, depressed and anxious regarding their research (from their personal insight offered during the meeting). use of entire page for the doodling (rather than just doing a number of small, precise, unrelated doodles) becomes a good indicator of the researchers' ability to concentrate productively on their research if they begin as depressed and anxious. when these researchers are able to expand from a focus on small, perfect doodles to expressing themselves over the entire page their satisfaction with their group participation increased. for those who weren't depressed and anxious, but still distressed, the doodling did permit them to relax and it was likely this feeling of being relaxed that encouraged a similar change in their doodles. a comparison between spontaneous doodling and the drawings produced to prompts shows interesting differences. with drawing to prompts, the researchers focus on whether they want to decline to participate. this is especially the case if researchers feel reluctant to draw because of a belief that their abilities are substandard. this response was particularly noted in those researchers who were more senior in their research careers. for those who did draw to the prompts, the focus was on: successful choice of materials and technique, telling a cohesive story with the finished work and conforming to limits of the page size. doodling, on the other hand, produced effects that were not noted in drawing to prompts. these effects included the following: interest in responding to the writing prompts increased, the ability of the participant to quickly ask and answer questions of others increased, and anxiety and depression casually self-reported was decreased. these effects were not noted in drawing to prompts, before doodling was introduced to the henreg. the analysis of the doodles of this health narratives research group is more extensive with respect to various parameters than previous studies; there seems to be a relationship between reported anxiety, depression and distress and changes in fig. doodle of three characters the researcher was in the process of creating cult med psychiatry doodling practice. nevertheless, the results from this study correspond to what can be concluded from the research on doodlers, that the effect of doodling relates to where, on the continuum of doodling (merely entertaining, relaxing or necessary for a researcher's creativity), participant views of doodling lie. those participants in the henreg who found doodling to be trifling were more likely to leave the group once they were called upon to doodle. those who experienced doodling as relaxing often stayed later to finish their doodles and were able to participate more fully in the primary aspects of the narrative work. those researchers whose doodles changed in relation to their self-reported depression, anxiety or distress were the ones whose saw doodling as relaxing. in contrast, doodling was not seen to reveal the psyche if researcher's creativity was somehow dependent on the creation of the doodles or doodling was considered merely entertaining. the major limitation of this work is that it was happenstance, which is to say, not undertaken purposefully; it might sooner be characterized as qualitative inquiry than research. consequently, it may be questioned whether qualitative inquiry can develop a tool for measuring changing levels of depression and anxiety. with no initial hypothesis regarding doodling, the relevant patterns that were seen to form as a result of doodling were only recognized retrospectively, sometimes years after the doodles were completed, rather than hypothesized in advance. had the idea that doodling would be related to self-reported levels of depression and anxiety been considered initially, the materials provided for doodling might have been standardized and the number of drawing prompts reduced (as drawing to prompts was seen not to be related to the self-perception of the psyche). nevertheless, it is notable that in spite of the deficiencies of the study the ability of doodles to represent the mental state of some researchers participating in the henreg was remarkable. however, it needs to be considered that the reason why doodling was able to detect changing levels of depression and anxiety in those who felt doodling relaxed them may be just because doodling has been consistently forbidden in academe. perhaps it was the encouragement of doodling in the health narratives research group, rather than the doodling itself, that brought with it the evident changes to the psyche. that this might be the case is reinforced by the finding that once group members expected to be permitted to doodle they were less likely to causally mention that they felt happier and less anxious. another limitation might be that rather than the process of doodling, it was the ability to make use of different art materials that many of the participants had never used before that encouraged their expression of happiness and feeling of being less anxious (kaimal and ray ) . it is notable that the purchase by the facilitator of new, sensually appealing art materials gifted to the group made each of the members feel less inhibited to doodle and more joyful about the process of creation. a final limitation of this work is that, because it was not undertaken purposefully, it is unknown what the results might have been had it been planned. it is likely that the results found in this one health narratives research group would not be reproducible if participants knew their doodles were related to a research study. the primary determinant of doodles being able to reflect the mental states of their creator has been found to be the ability of the doodler to relax as a result of doodling. consequently, if participants had felt constrained in doodling, the hopedfor result would not have been evident. for this reason, attempting to recreate this research requires a very particular method, similar to the one promoted by the health narratives research group. doodling has been maligned in academic settings with increasingly punitive outcomes in public education settings. based on the evolving research on the value of doodling aided by the study of doodles produced at the university of toronto health narratives research group, doodling should be reassessed as a possible indicator of internal states of distress, dysphoria, depression and anxiety under certain well-defined conditions as changes in doodling may serve as a measure of change in these internal states. for doodling to become an important ingredient in reducing burnout in researchers, similar opportunities to participate with other researchers in egalitarian settings-along with paper and various art materials-need to be provided so that doodling production is aided. as well, the facilitator of these groups must be viewed by group members as trustworthy and supportive in encouraging doodling since the ramifications for doodling in other academic settings can be so severe. in the meantime, educators would do well to consider doodling as part of the type of spectrum suggested by the article by maclay et al. in this regard, doodling can be merely entertaining, it can be relaxing (thus able to measure depression and anxiety) or it can be crucial for creativity. if academics can tap into the mid-point of the spectrum for doodling that permits doodling to be relaxing, then this component likely can act as an aid to identify the levels of depression and anxiety-an initial ingredient to alleviate burnout and its detrimental effects in researchers. department of psychiatry, the faculty of medicine or to the mount sinai hospital. the only incentive for those participating in the health narratives research group she facilitates is it being free of charge to participants. since , the author has been provided with three $ grants from the health arts and humanities program of the university of toronto department of psychiatry for facilitating the health narratives research group. pre covid- , weekly meeting space for the group was provided at the toronto mount sinai hospital through the department of psychiatry. the author receives no remuneration from the university of toronto or the mount sinai hospital. consent to participate members were provided with written information that the henreg was a voluntary, non-credit group encouraging diversity that members may join at any time. in responding to this written information by email, participants acknowledged their understanding that they were under no obligation to attend any specific number of meetings or to continue as part of the group. consent to publish approval to use the information pertaining to, and doodles of, henreg participants was granted by each member in email or messenger responses to the author in agreeing to join the group upon being provided with the following information: ''by joining, members agree their work may be anonymously referenced in presentations given and/or scholarly articles written by the facilitator regarding the yearly results of the henreg.'' ethics approval this is an observational study. research ethics board approval was not obtained as there was no formal research undertaken and the author is not employed by either the university of toronto or the mount sinai hospital. her facilitation of the health narratives research group (henreg) is on a volunteer basis. no participants were harmed as part of the henreg. what does doodling do? burn-out an ''occupational phenomenon the effects of the leisure activity of coloring on post-test anxiety in graduate level occupational therapy students the negative effect of doodling on visual recall task performance who drew stickman holding gun suspended from school over doodle understanding the persona of clinical instructors: the use of students' doodles in nursing research just let my kid doodle! dealing with a teacher who's sweating the small stuff routledgefalmer. freudenberger, herbert j. staff burn-out call for a moratorium on the use of the rorschach inkblot test in clinical and forensic settings ridiculous instances of zero tolerance in schools on philosophy as therapy: wittgenstein, cavell, and autobiographical writing do burnout and work engagement predict depressive symptoms and life satisfaction? a three-wave seven-year prospective study a rating scale for depression the assessment of anxiety states by rating anxiety and depression in the workplace: effects on the individual and organisation (a focus group investigation) wittgenstein and psychotherapy: from paradox to wonder burnout research: emergence and scientific investigation of a contested diagnosis. sage open - drawing a close to the use of human figure drawings as a projective measure of intelligence free art-making in an art therapy open studio years in prison for a harmless prank? handcuffed for doodling? the increasing criminalization of students spontaneous drawings as an approach to some problems of psychopathology comparing the influence of doodling, drawing, and writing at encoding on memory the social psychology of expertise: case studies in research, professional domains, and expert roles philosophy as therapy: an interpretation and defense of wittgenstein's later philosophical project the ''thinking'' benefits of doodling professional burnout: recent developments in theory and research doodling and the default network of the brain. the lancet defense of doodling. university affairs does doodling effect performance: comparison across retrieval strategies burnout basics: the warning signs and what to do about it effectiveness and efficiency of adding drawing prompts to an interactive educational technology when learning with visual representations who recognizes workplace 'burnout' as a medical syndrome acknowledgement the author would like to thank edward shorter, jason a. hannah professor in the history of medicine, university of toronto, for reading and commenting on drafts of this paper and providing advice regarding publication and allan peterkin, professor of psychiatry and family medicine at the university of toronto and director of the health, arts and humanities program, for his support of the health narratives research group since through the mount sinai hospital. conflict of interest the author has no known conflict of interest with respect to this work. the author is scholar in residence in the history of medicine program, a program associated with the department of psychiatry, faculty of medicine, university of toronto. she has no direct, formal appointment to the key: cord- - fnfs e authors: leung, t.y.; sharma, piyush; adithipyangkul, pattarin; hosie, peter title: gender equity and public health outcomes: the covid- experience date: - - journal: j bus res doi: . /j.jbusres. . . sha: doc_id: cord_uid: fnfs e this paper extends the growing research on the impact of gender equity on public health outcomes using the ongoing covid- pandemic as its research setting. specifically, it introduces a conceptual model incorporating the impact of gender equity and human development on women’s representation in legislature and public health expenditure, and their combined impact with human environment (population density, aging population and urban population) on important public health outcomes in the covid- context, including the total number of tests, diagnosed, active and critical cases, and deaths. data from countries shows support for many of the hypothesized relationships in the conceptual model. the results provide useful insights about the factors that influence the representation of women in political systems around the world and its impact on public health outcomes. the authors also discuss implications for public health policy-makers to ensure efficient and effective delivery of public health services in future. the unprecedented devastation caused by the ongoing covid- pandemic has aroused public attention on the need for a proper public health policy (herper, ; king, ) , especially due to the disproportionately large number of infected cases and deaths in the developed countries, led by the united states, followed by spain, italy, france, germany, the united kingdom and others (worldometers, ) . as the debates continue to fix the responsibility for the birth and spread of this deadly virus and the lack of readiness to handle its disastrous impact (patterson, ; qato, ; smakaj, ) , public health experts seem to mainly view it through the lens of medicine, epidemiology, and health science disciplines. however, public health is an interdisciplinary subject that involves social sciences, public policy, public education, economics, and management (jambroes et al., ; tulchinsky & varavikova, ) . hence, a failure to have a proper public health policy may not only lead to a huge loss of human lives; it can also shatter the economy, expose the incompetence of the public bodies including the governments and political leaders, and weaken the confidence of the general public (united nation, ) . in this context, gender equity is recognized as an important factor to influence the quality of public healthcare systems and their outcomes (who, ) . although women are underrepresented in leadership positions in healthcare, their significance in other leadership positions cannot be underestimated, as evident from the growing numbers of women ceos, politicians, and heads of governments (mayer & oosthuizen, ) . women leaders are strong advocates for immunization programs, education and equal employment opportunities (beaman, duflo, pande, & topalova, ) . women senators lobbied for the breast and cervical cancer mortality prevention act in the us (lee et al., ) . gender equity also has positive effects on firm performance and governance (post & byron, ) . this paper extends the growing research on the impact of gender equity by exploring its impact on public health outcomes using the ongoing covid- pandemic as its research setting. the authors begin with an extensive review of the relevant literature to develop a conceptual model and specific hypotheses about the impact of gender equity and human development on women's representation in legislature and public health expenditure, and the combined impact of public health expenditure along with human environment (population density, aging population and urban population) on important public health outcomes in the covid- context, including the total number of tests, diagnosed, active and critical cases, and deaths. the authors use the data from countries to find support for many hypotheses. the results provide useful insights about the factors that influence the representation of women in political systems around the world and its impact on public health outcomes. the authors also discuss implications for public health policy-makers to ensure efficient and effective delivery of public health services in future. public health winslow ( ; p. ) defines public health as "the science and art of preventing disease, prolonging life, and promoting physical health and efficiency through organized efforts for the sanitation of the environment, the control of community infections, the education of the individual in principles of personal hygiene, the organization of medical and nursing service for the early diagnosis and preventive treatment of disease, and the development of the social machinery which will ensure to every individual in the community a standard of living adequate for the maintenance of health". in other words, public health is not just about medical science of epidemiology, diagnosis, and cure, and it is also linked to social science, which includes politics, management, welfare, and public policy. past research shows significant psychological and cognitive differences in personality, values, and concerns between women and men. for example, women tend to be more cautious (lundeberg, fox, & punćochaŕ, ) , risk-averse (agnew, anderson, gerlach, & szykman, ; byrnes, miller, & schafer, ) , and fatalistic (pandey & jain, ) than men. women put more emphasis on risk attributes (e.g., possibility of loss) in investment decisions than men (olsen & cox, ) and perceive more risk in traffic and environmental hazards (dejoy, ; fllyn, sloic, & mertz, ) . besides being risk averse, women are also loss averse (brooks & zank, ) . in addition, there is a difference in risk-taking behavior between female and make leaders for the decisions making for themselves and their groups. ertac and gurdal ( ) show male leaders take more risk for the decisions made for their own and the groups than male non-leaders. on the contrary, female leaders take less risk on behalf of a group which is lower than that taken individually. these differences in overconfidence and risk aversion levels between females and males make females to be more cautious and take less risk in making decisions. hence, the authors hypothesize as follows: h . gender equity has a positive effect on, a) representation of women in legislature, and b) public health expenditure. past research shows that public health outcomes are influenced by indicators of human development, such as education (ross & wu, ) , employment, income disparity etc. because these variables impact the access to public health infrastructure and general health of populations. human development is related to health condition. education level and economic condition are factors influencing health status. the well-educated are less likely to have economic hardship. they also have a greater sense of healthiness and healthier behaviors such as less/no smoking, more physical exercise, and medical check-ups to improve their health. the wealthier people with higher income have greater purchasing power for healthier lifestyle (healthy food, better nutrition, more protected medical insurance). ross and wu ( ) find education level has positive effect on health through work and economic condition, social-psychological resources, and health lifestyle. hence, . human development has a positive effect on, a) representation of women in legislature, and b) public health expenditure. representation of women in legislature has a positive effect on public health expenditure. at the time of writing this paper, more than . million cases of covid- have been diagnosed worldwide, with about two-third of these cases still active and about , deaths (worldometers, ) . most recent studies examine these outcomes from a medical or therapeutic perspective (e.g., murthy, gomersall, & fowler, ) despite much debate in media on the role of public policy makers, politicians, and general public in the spread of this virus. past research shows a positive link between public health expenditure and its outcomes (kim & lane, ) , such as infant mortality and life expectancy rates (nixon & ulmann, h . public health expenditure has a positive effect on the total number of covid- a) tests, b) diagnosed, c) active, and d) critical cases, and e) a negative effect on the number of deaths. human environment, which consists of elements such as population density, urbanization, and age structure, is a major factor influencing public health. world health organization reports the negative impact of high population density and urbanization on mental and physical health (who, a, b) . rapid urbanization in most countries in the last few decades has led to inadequate housing, congested public transport, poor hygiene, and high pollution level (air, water, and noise), which results in physical and mental health problems (who, b) . in fact, infectious diseases and epidemics (e.g., tuberculosis, pneumonia) are also more likely to happen in densely populated and urban areas (who, a, b). as higher population density is expected to lead to more active transport, more perceived stress and smoking, it has negative effects on mortality (beenackers, groeniger, kamphuis, & van lenthe, ) and health conditions (greiner, li, kawachi, hunt, & ahluwalia, ) . similarly, age structure of a population affects the social (e.g., social protection), economic (e.g., labor force), and health (e.g., healthcare for elderly) systems and policies of a country. the functioning of the immune system declines with age, which influences the physical strength of the elderly to respond to infection. there is a negative relationship between physical health condition and age (ma et al., ; sun et al., ) . hence, as follows: between the predictor and outcome variables helps eliminate any concerns about endogeneity or reverse causality (mertens, pugliese, & recker, ) . moreover, all the measures are either indices or ratios, to avoid confounds due to any other between-country differences. the authors use path analysis with smartpls . to test all the hypotheses because they have a relatively small sample (n= ) of secondary data with many ratios and other artifacts that may not be normally distributed and their conceptual model is quite complex with many construct and relationships (hair, risher, sarstedt, & ringle, ) . all the vif (variance inflation factor) values are less than the recommended cut-off value of three, hence multicollinearity is not a concern (hair et al., ). next, r-square values are high for many outcome variables (e.g., number of tests = . , diagnosed cases = . , and deaths = . ), hence the model explains a significant proportion of variance in these variables. high values of the blindfolding-based cross-validated redundancy measure q also confirm the predictive accuracy of the pls path model (hair et al., ) . finally, a low srmr ( . ) and high nfi ( . ) also show a good model-fit in view of the many missing values in the dataset. table shows the correlations and descriptive statistics for all the variables and table reports health experts argue that women should be involved in all stages of public health management, including planning, decision-making, and emergency response systems, moreover, the lack of any significant impact of public health expenditure on the number of tests or deaths may indicate possible mismanagement of public health systems due to unclear policies and priorities in many countries during this crisis, which has already led to calls for improvement in future (patterson, ; qato, ) . both aging population and urban population have significant positive effects on the number of tests but only urban population has a positive effect on the number of deaths, which is not surprising as these two population segments have been the worst hit by the covid- outbreak so far (keil, connolly, & ali, ) . interestingly, population density has no impact on the number of tests or deaths, which suggests some biases in the way these tests are being conducted and the deaths are being reported (kwiatkowski & nadolny, ) . there is growing evidence that the covid- crisis impacts men and women in different ways, including healthcare workers, patients, their family members and the society at large; and therefore, the measures to address this crisis and its outcomes should take these gender differences into account (linde & gonzalez, ; papp, & hersh, ) . for example, women tend to be more vulnerable at home and in the workplace, due to which they are more likely to suffer the economic impact of covid- crisis (linde & gonzalez, ) . moreover, women comprise % of the global healthcare workforce and their experiences during the covid- pandemic are significantly different to those of their male counterparts, especially due to the unique risks and vulnerabilities faced by women due to "deep-rooted inequalities and traditional gender roles" (papp & hersh, ) . therefore, public health agencies and policy makers need to look at the covid- pandemic through a gender lens in order to identify and implement the most effective policy responses. all the issues identified in this paper, such as under-representation of women in leadership positions, possible mismanagement of public health systems and inconsistent or incorrect reporting of the public health outcomes in this context, need to be addressed not only for a quick economic recovery in the aftermath of this covid- crisis but to also prevent and manage such disasters in future. clearly, covid- has revealed the vulnerabilities of the modern civilization and economic systems, wherein the so-called developed countries account for most of the diagnosed cases and deaths, although it is still early days and we need to wait to see its impact on the less developed countries in asia, africa and latin america, before we can make a full assessment and recommendations, especially about the role of gender equity in managing this crisis. who chooses annuities? an experimental investigation of the role of gender, framing, and defaults female leadership raises aspirations and educational attainment for girls: a policy experiment in india urban population density and mortality in a compact dutch city: -year follow-up of the dutch globe study loss averse behavior gender differences in risk taking: a meta-analysis an examination of gender differences in traffic accident risk perception deciding to decide: gender, leadership and risk-taking in groups gender, race, and perception of environmental health risk the relationships of social participation and community ratings to health and health behaviors in areas with high and low population density when to use and how to report the results of pls-sem the coronavirus exposes our health care system' weaknesses. we can be stronger a new concept of health -implications for public health policy and practice: a qualitative analysis outbreaks like coronavirus start in and spread from the edges of cities. the conversation government health expenditure and public health outcomes: a comparative study among countries and implications for us health care reform covid- and the need for health care reform at least , nursing homes have coronavirus cases and the reality is likely much worse implementation of the national breast and cervical cancer early detection program: the beginning the pandemic's gender imperative, project syndicate highly confident but wrong: gender differences and similarities in confidence judgments associations between chronic disease, age, and physical and mental health status concepts of creative leadership of women leaders in st century causality: endogeneity biases and possible remedies care for critically ill patients with covid- the relationship between health care expenditure and health outcomes the influence of gender on the perception and response to investment risk: the case of professional investors worldviews and perceptions of environmental problems a gender lens for covid- , project syndicate how to reform healthcare after covid- women on boards and firm financial performance: a metaanalysis our public health infrastructure is losing a fight with capitalism. jacobin magazine the links between education and health covid- and the need for deep eu reform population health status in china: eq- q results, by age, sex and socio-economic status, from the national health services survey the new public health global human development indicators, united nations development programme human development reports everyone included: social impact of covid- the untilled fields of public health strengthening preparedness for health emergencies; implementation of international health regulations (ihr, ), world health organization statement by dr zsuzsanna jakab, who regional director for europe, for international women's day, world health organization population density -a growing concern, health situation and trend assessment urban health. world health organization world bank open data note: total number of countries for each characteristics is subject to availability of data. key: cord- -hdkpzsmm authors: carta, mauro giovanni; romano, ferdinando; orrù, germano title: the true challenges of the covid- epidemics: the need for essential levels of care for all date: - - journal: open respir med j doi: . / sha: doc_id: cord_uid: hdkpzsmm nan in the last decades, biomedical research and funding supporting it have given a relevant impulse to developing socalled "personalized medicine" (pm) and "precision medicine" (the latter definition with emphasis on the usefulness of dividing patients into target groups). this perspective has increased knowledge on how we can predict disease susceptibility and prognosis in a person or how we can define a tailor-made treatment on specific individual immune-genomic characteristics and disease and thus improve the health of such a person [ ]. all this represents an exhilarating challenge that has led to the discovery of treatments of unimaginable efficacy up to a few years ago. however, this recent advance in research seems to have had a price. in most countries, care of excellence is only for those who can afford it, but even in countries with strong national health systems, the commitment to individualized care may have diverted resources and attention from creating systems that guarantee protection for all. a health system that ensures well-being for all should not be in contradiction but rather complementary to medicine that tends to individualize treatments of excellence. nevertheless, it is undeniable that the attention of researchers in recent years has not focused on public health and the sustainability of everyone's well-being. in fact, several leading causes of mortality remain unaffected by pm [ ] . it is well known that infections of the respiratory tract are a major cause of morbidity and mortality worldwide [ ] . if also in this field precision medicine has significantly contributed to improving disease prognosis [ ], three successive coronavirus epidemics (sars, mers and covid- ) have shown how deficiencies in providing an immediate and integrated medical responses, a certain inability to manage information and coordinate responses at local, natio-* address correspondence to this author at the university of cagliari, cagliari, italy; tel + ; e-mail mgcarta@tiscali.it nal and international levels can favor the outbreak of epidemics that could be managed with less impact [ , ] . in conclusion, it appears that something essential is missing: health services capable of responses for all, ability to correctly communicate health information, and skills in integrating care at various levels. on the other hand, another awareness is emerging. that is, in the face of an epidemic, especially a respiratory epidemic with a strong infectious capacity (although in this case with low lethality), there can be no privileged areas immune from infection on the basis of one's own well-being and wealth. the covid- has hit middle-high-class of people on a cruise and wuhan and wealthy lombardy cities in italy, as well as suburban areas of the same asian and european metropolises. today there are reasons to fear that the impact and invasiveness of the epidemic could be amplified by the contagion of the population groups without assistance or with low-level assistance in rich nations and of low-income nations without a minimum health system. this means that in terms of public health, defending the health of deprived areas and creating a network with a minimum level of assistance for all means prevention for everyone. this is not to deny the importance of individualized medicine or of the great innovations that healthcare has introduced in these fields. but we must learn from this lesson that if we fail to guarantee a minimum support for everyone in terms of health services, prevention and treatment, we risk endangering everyone's health, not only that of people without privileges. the faces of personalized medicine: a [ ] framework for understanding its meaning and scope a public health approach to innovation systematic analysis of population health data precision medicine in the clinical [ ] management of respiratory tract infections including multidrugresistant tuberculosis: learning from innovations in immuno-oncology covid- ) epidemics, the newest and biggest global health threats: what lessons have we learned? straining the system: novel coronavirus covid- ) and preparedness for concomitant disasters key: cord- -v n ez t authors: bayen, eleonore; stefanescu, françois; robert, hélène; weil-chounlamountry, agnès; villain, marie; gouriou, clémentine; gueorguieva, sofia; picq, christine; bruguière, pascale; pradat-diehl, pascale title: will participation restrictions related to the covid- lockdown boost inclusivity? date: - - journal: ann phys rehabil med doi: . /j.rehab. . . sha: doc_id: cord_uid: v n ez t nan restrictions for a long time, whatever their impairment (e.g., motor, cognitive-behavioral, respiratory) and disease (e.g., traumatic spine and brain injury, stroke). the international classification of functioning, disability and health (icf) from the world health organization (who) provides a structuring framework to understand disability . in this biopsychosocial model, disability involves dysfunction in one or more of different levels due to a given health condition: first, impairments (e.g., hemiplegia); second, activity limitations (e.g., inability to walk outside); and third, participation restrictions (e.g., not being able to perform a professional or social community activity). importantly, the icf points out how environmental factors (e.g., a wheelchair-accessible area or a dementia-friendly society) can be either facilitators or barriers to the everyday life functioning and social integration of the person. thus, people living with a disability are used to developing adaptive behaviors to cope and lower the social and physical barriers they encounter in their environment. because the disability stems from the interaction between the features of a person and the features of the overall context in which the person lives, it has the potential to evolve. the present social lockdown context has immersed half of the planet in a disability situation (as defined in the who model), thus inverting individuals' usual perspectives of capacity, growth and performance. participation restrictions have become the norm in nations and on a global scale as opposed to being the fate of a minority of excluded groups who experience stigma. healthy individuals are currently walking their individual psychological paths and developing coping strategies based on the conviction that these enforced restrictions are temporary and reversible (e.g., not being able to access their workplace or enjoy a walk in a park). but fear, frustration and isolation have also placed trapped citizens of the world in the shoes of those living with a long-term disability. the context of collective resilience enables us reflect on the life of those of us who endure a permanent lockdown situation due to severe health conditions or socioeconomic vulnerabilities (e.g., forced migration and poverty). the covid- war has brought human and economic suffering and a heavy death toll. yet, it also has some positive solidarity and brotherhood counterparts: a major unexpected counterpart could be boosting inclusivity at local, regional, national and planetary levels because citizens are becoming more conscious of handicap. being more inclusive means stepping up to dismantle barriers (as defined by the icf) that are physical and mental obstacles to welcome each person whatever their situation. weeks of confinement have been training our brains to be empathetic and disabled-friendly and to think universal. as many others, physicians of physical and rehabilitation medicine are humbly trying to alleviate the disability situations in people's life. we believe that massive quarantines stand as an opportunity to sustainably educate societies about handicap. thus, we hope that the lockdown experience will help redesign social justice in our ecosystems and pave the road for more inclusivity in post-covid societies. none declared. world health organization. the international classification of functioning, disability and health. geneva: world health organization key: cord- -apgdzgfz authors: lewis, thomas j; huang, jason h; trempe, clement title: reduction in chronic disease risk and burden in a -individual cohort through modification of health behaviors date: - - journal: cureus doi: . /cureus. sha: doc_id: cord_uid: apgdzgfz introduction health risk factors, including lifestyle risks and health literacy, are known to contribute to the chronic disease epidemic. according to the centers for disease control and prevention (cdc), chronic diseases account for % of healthcare costs, morbidity, and mortality. in the united states, healthcare providers attempt to modulate a limited set of risks. however, chronic diseases continue to proliferate despite expansion of wellness programs and drugs to manage and prevent chronic conditions. pandemics, exemplified by severe acute respiratory syndrome coronavirus (sars-cov- ), show that people in good health suffer mortality rates at % the rate compared to those with pre-existing chronic conditions. healthcare costs and morbidity rates often parallel mortality rates. new root-cause risk and health tools that accommodate low health literacy and are linked to personalized health improvement care plans are needed to reverse the chronic disease epidemic. reported here is a study on manufacturing employees in the midwest us using a personalized and group approach to chronic disease reversal and prevention which may also find utility in pandemic severity and policy decisions. methods health, lifestyle, behavior, and motivation data were collected on individuals at the beginning of a nine-month disease reversal and prevention program. the data were updated every two to six months over the period. inputs included information from a novel health risk assessment, serum biomarkers specific for chronic disease, and traditional medical information. using all these data we generated robust, personalized, and modifiable care plans that were implemented by the participant and guided by a care team including health coaches and medical providers. periodic renewal of profile data and biomarkers facilitated adjustment of care plans to optimize the path toward health goals set mutually by the participant and the care team. results ninety percent of participants experienced a favorable reduction in chronic disease biomarkers. the reduction in serum biomarkers coincided with a reduction in disease and risk attributes based on medical chart data and before and after interviews. hemoglobin a c, for example, lowered in all but one participant concomitant with reported improved energy and reduced need for medications in the majority of participants. markers of inflammation lowered across the population. most importantly each individual reported improvement in their overall health. conclusions this simple, inexpensive, root-cause based risk and health approach generates a “do no harm” action plan that guides a care team, including the participant, on a path to improved health. the data demonstrate that changes in a novel risk calculator score coincide with changes in sensitive biomarkers for chronic disease. when the risks of an individual are reduced, the biomarkers reflect that change with self-reported wellbeing also improved. this program and process may be of value to society plagued with escalating levels of chronic disease and merits further study and implementation. developed nations, and particularly the united states, continue to confront a chronic disease crisis. the world health organization (who) reported that in , non-communicable chronic diseases including: cardiovascular diseases, diabetes, cancers, and chronic respiratory diseases, accounted for / of deaths worldwide [ ] . the institute of medicine reported that america is less healthy compared to high income nations in obesity, diabetes mellitus, heart disease, chronic lung disease, and disability [ ] . the organization of economic cooperation and development (oecd) tracks the health of developed nations. the u.s. scores in the lower half among these nations on all major indicators of health, and longevity. when considering that the per person per year cost of healthcare in the united states is more than two and a half times that of the oecd nation average, yet our residents live . years less, a health paradox exists in the united states. this u.s. paradox is the worst cost-to-value benefit for chronic disease outcomes compared to the average of other developed nations. the chronic disease management system is failing people at both ends of the health spectrum. a root of the problem is that health and prevention recommendations currently supported by the major medical societies have proven ineffective at reversing or preventing chronic diseases. laboratory tests in common use remain of limited scope and provide little insight into chronic health status. pharmaceuticals prescribed based on test results have poor absolute statistical success at preventing or reversing disease. these assertions are borne out since % of the nation's nearly $ trillion in annual health care expenditures are for chronic conditions per the cdc. and the situation is not improving, for example, cardiovascular disease mortality, managed with statin drugs, blood pressure medications, and other usual care approaches across broad members of the u.s. population, increased nationally by . % between and [ ] . on average, residents of the united states with five or more chronic conditions spend times more on health services than people with no chronic conditions [ ] . as of , % of u.s. adults had at least one chronic condition, and % had more than one chronic condition. five percent of the population accounts for an estimated %- % of total health care expenses [ ] . the most expensive health conditions account for % of total health care expenses. the financial and productivity costs impact our corporations, who fund over half of the national healthcare at a price of roughly % of their gross revenues. and much of this cost is segmented in high-cost beneficiaries where, for example, the top % of claimants cost $ , /y compared to the population mean of $ /y. in a report compiled by the health care cost institute, there is a surprising large turnover from year to year among the highest cost healthcare spenders. three out of five top spenders in any given year were low or moderate spenders in the prior year. in , only % of the top % of spenders were in the top % of spenders in . moreover, this trend was consistent in each year from to . there is a need for better predictive analytics to determine who is and, more importantly, will be in this significantly high-cost segment of any population as a current tool, claims data, lacks predictive power. in pandemics, standard tests provide little information on projected outcomes, rather they simply indicate exposure and potential immunity. healthy people are much less likely to die compared to unhealthy or older people. physiological health, the main concern of practicing clinicians, is not well characterized through these tests. further, the main cause of death appears to be cytokine storm syndrome which is driven by innate, not adaptive immunity [ ] . thus, antibody testing does not adequately describe disease risk or severity. validated data on severe respiratory viral diseases and the correlation between mortality, immunocompromised status and existing chronic conditions in infected individuals indicate that a broad set of blood-based biomarkers may best serve to stratify risk and to set policy on containment strategies in populations [ ] . currently, the policy is being established with an incomplete set of evidence. in vivo blood biomarker analysis offers considerable opportunities for individual and population risk measurement. these tests afford fast analytical turn-around time, quantitative measurement, accessibility, serial monitoring and ready availability. in some instances, rapid and continuous monitoring is available. the measurement of and changes to a broad range of modifiable risk factors, and biomarkers connected to immune system activity through cytokine surrogates, offers the most important opportunity for the prediction of disease and improvement in global chronic and pandemic disease status. most industries recognize the value of early problem intervention. in the waste management industry, for example, there is a clear hierarchy of: . source reduction, . recycling, . treatment, and . land disposal. in healthcare, there is also a potential for a four-tiered approach to health maintenance: . prevention, . mitigation of asymptomatic disease in people with elevated predictive biomarkers, . mitigation upon the earliest detectable signs of early disease (dry macular degeneration is an example), and . advanced root-cause mitigation approaches within disease management approaches. most of the efforts in today's healthcare is on disease management with usual care which is only a small part of this suggested four-tiered approach. the who addressed major causes of chronic diseases with modifiable risk factors being: unhealthy diet; physical inactivity; and tobacco use. in addition, the who stated "these causes are expressed through the intermediate risk factors of raised blood pressure, raised glucose levels, abnormal blood lipids, overweight and obesity. the major modifiable risk factors, in conjunction with the non-modifiable risk factors of age and heredity, explain the majority of new events of heart disease, stroke, chronic respiratory diseases and some important cancers. the relationship between the major modifiable risk factors and the main chronic diseases is similar in all regions of the world." studies show that the u.s. experiences the same risks as exist globally. dietary factors, alone, are associated with nearly half of all cardiometabolic deaths. the highest proportions of cardiometabolic deaths were estimated to be related to excess sodium intake, insufficient intake of nuts/seeds, high intake of processed meats, and low intake of seafood omega- fats. dramatic changes in disease rates among migrating populations indicate that the primary determinants of these diseases are not genetic but environmental factors, including diet and lifestyle [ ] . studies on twins separated at a young age corroborate that chronic disease is much more related to environmental factors. expansion of the depth and breadth of risk assessment and concomitant prevention and disease amelioration programs represent an unmet healthcare need. a well-studied disease prevention arena is corporate wellness programs. most of these programs rely on "usual care" that includes: basic dietary recommendations, weight loss, smoking, alcohol consumption and metabolic and lipid index targets. a broad-based team of wellness professionals and academics evaluated workplace wellness programs. they unanimously concluded that few wellness programs meet expectations and most are abysmal failures. what separates bad, good, and great programs is "a combination of good design built on behavior change theory, effective implementation using evidence-based practices, and credible measurement and evaluation." to further support the need for more thorough risk assessment, in a global study of risks, the authors concluded "increasingly detailed understanding of the trends in risk exposure and the relative risks for each risk-outcome pair provide insights into both the magnitude of health loss attributable to risks and how modification of risk exposure has contributed to health trends [ ] . these types of data clearly illustrate a path to improved health outcomes through broader and deeper precision and personalized assessment. the risk evaluation tool used in this study, the chronic disease assessment™ (cda), is an on-line health risk assessment and mitigation tool and involves answering approximately questions that probe deeply into lifestyle and environmental sources of risks, behaviors, health attitudes, readiness to change, current and past complaints, problems and diagnoses. the output of the cda is an overall risk score and then sub-sets of scores by risk categories, and a score for each question/answer combination. the overall raw risk score is converted into a letter "grade" reflecting the extent of the individual's risk "portfolio." the letter grade is provided to participants as an easily understood value for their risks, to overcome a lack of health literacy that especially impacts high risk populations. in addition, the cda output generates a series of actions that provide personalized education and actionable solutions to each risk in a participant's risk portfolio. finally, a health revival care plan™ is generated from the risk portfolio, and adjusted by the health coach and the participant, to create a simplified, personalized roadmap to overcome risks and improve health. a major impediment to health improvement is low health literacy. the de facto intervention perpetuating this problem is a prescription for symptom management that requires little knowledge by the patient. deficits in health literacy are associated with poorer health outcomes and higher health-related costs for both individuals and systems. improved health literacy has been associated with reductions in risk behaviors for chronic disease, and decreased rates of hospitalization [ ] . health literacy is a critical and under-examined component of health disparities. according to the national assessment of adult literacy, over a third of u.s. adults have basic or below basic health literacy and have difficulty managing common health-related tasks. limited health literacy poses a significant economic burden to our society, with national estimates indicating that low health literacy costs the u.s. healthcare system from $ to $ billion each year in healthcare dollars [ ] . the nexus of this program, including the cda risk portfolio, actions, care plans, and health coaching, is designed to meet and exceed the united states department of health and human services national action plan to improve health literacy's three goals: ensuring equitable access to health information; creating 'person-centered health information and skills' and supporting the development of the skills needed to attain and maintain good health. a final important aspect of this process, not articulated by the action plan, is illumination of the connection of risks to problems and complaints. the cda collects and reports risks, problems, and complaints together. thus, participants are able to "connect the dots" between risks and problems, like oral health and joint pain or carbohydrate intake and fatigue, as examples. these upstreamdownstream connection realizations improve health literacy and stimulate more sustainable change which manifests in the adoption of actions and plans to eliminate the risks as a solution to their problems as opposed to the usual care option of a drug to control symptoms. this process empowers individuals to be a participant in their own health improvement through recognition of their control over causes and outcomes. within this study, health coaches interacted face-to-face and electronically with participants and groups of participants to implement care plans. coaching activates patients to change through collaborative learning and social support. patient engagement and p medicine, defined as predictive, preventive, personalized and participatory, is an increasingly important component of strategies to prevent and reverse chronic disease, at least within the functional and integrative medical communities. interventions that tailor support to the individual's level of activation, and that build skills and confidence, are effective in increasing patient activation. more highly activated people are more likely to engage in healthy behavior such as eating a healthy diet and getting regular exercise while avoiding health-damaging behavior such as smoking and illegal drug use. these behavioral changes have led to lower rates of hospitalizations and emergency department visits, compared to less activated patients [ ] . a bridge between risk factors and modification in certain intermediate factors like blood pressure and obesity are changes to blood-based biomarkers, which are more objective measures of health. the most routinely performed tests in usual care are for the assessment of kidney and liver health, blood chemistry, lipid markers and metabolic markers. heart disease continues to be the number one cause of morbidity and mortality in the u.s. and globally despite the broad use of cardiovascular disease medications for both prevention and intervention. a study of , patients hospitalized with a heart attack between and showed that almost % had ldl cholesterol levels within guidelines [ ] . these data imply there is room for testing to augment evaluation of cardiovascular risk and cause. in older populations, "concentrations of homocysteine alone can accurately identify those at high risk of cardiovascular mortality, whereas classic risk factors included in the framingham risk score do not" [ ] . in healthy men, adding creactive protein levels to traditional risk factors, the reynolds risk score, improved cardiovascular risk prediction. the intermountain risk score uses common blood measures and assesses risk from the group of markers to develop a risk score. although limited in application, this scoring system has been reported to be predictive of increased mortality risk and provides patients with a more definable goal, the improvement of the score. more comprehensive assessments for risk and disease are emerging including the "allostatic load" and "inflammaging" concepts. each of these approaches considers a broader molecular view, rather than an organ system view of disease. according to mcewen, "when these (our body's) adaptive systems are turned on and turned off again efficiently and not too frequently, the body is able to cope effectively with challenges that it might not otherwise survive. however, there are a number of circumstances in which allostatic systems may either be over-stimulated or not perform normally, and this condition has been termed "allostatic load" or the price of adaptation" [ ] . diabetes is a relevant example, where insulin production is frequently elevated in response to regular highly absorbable carbohydrate intake. claudio franceschi coined the term "inflammaging" in to describe the concept of low-grade chronic inflammation and its impact on health. inflammaging was described as an extension of the "network theory of aging" [ ] . similar to the allostatic load, a global reduction in the capacity to cope with a variety of stressors and a concomitant progressive increase in proinflammatory status are considered the major characteristics of the inflammation aging process and susceptibility to premature disease and mortality. biomarkers for inflammaging are readily available and inexpensive but seldom obtain in usual care, especially in the implementation disease prevention strategies. according to gay et al., the allostatic load leads to dysregulation of the neuroendocrine system and subsequent elevation in inflammatory markers, leading to metabolic syndrome and chronic diseases such as cardiovascular disease [ ] . thus, the allostatic load and inflammaging are both measured, at least in part, with inflammatory markers like c-reactive protein, cortisol levels, glycosylated hemoglobin, white blood cell counts, and fibrinogen as examples. independent of inflammatory markers, multiple biomarkers, in general, improve the predictive power of a panel. in a study of people assessed with biomarkers, persons with multi-marker scores in the highest quintile as compared with those with scores in the lowest two quintiles had elevated risks of death and major cardiovascular events of . and . (adjusted hazard ratios), respectively [ ] . this far exceeds the predictive hazard ratio for cholesterol which varies from . to . depending upon the study [ ] . a hazard ratio of < means cholesterol levels were determined to be protective and stave off early mortality. numerous studies and reviews consistently show the value of multiple markers in real-world prediction of disease events and premature mortality. the chronic disease temperature™ (cdt) risk scale used in this study combines emerging concepts for improving the evaluation of disease risk and measurement of active disease. the significant attributes of the cdt scale are: . consideration of multiple biomarkers, . selection of markers based on traditional and new predictive markers based on inflammaging and the allostatic load, . harmonizing each marker to a standard endpoint -increase in early mortality risk, . consideration of risk contribution based on log-linear deciles of marker levels and individual marker hazard ratios for mortality, and . combination of the risk values from each marker into a single number score to accommodate limited health literacy and to set an understandable objective target for health improvement. the aggregate cdt score is an indicator of early mortality and associated total morbidity, while the values for each marker reflect both mortality risk and disease risk based on the association of a given marker to disease. this single number may be an important bridge to better health literacy as most patients do not understand the meaning of their current lab values. the cdt does not constitute a medical diagnosis of disease any more than does any individual marker, like homocysteine, but does statistically afford better predictive capability and measurement of disease progression or regression. the cdt output promotes the concept that health and disease lie on a log-linear continuum rather than being an on/off switch. in this study, the implementation of risk assessment, health and disease measurement, care plans, and frequent measurement leading to continuous improvement represents a needed response to challenges society faces from chronic diseases. this "systems approach" is designed to better connect across fragmented divisions in healthcare without bias of discipline. that is, fundamentally, most chronic diseases are connected at root-cause physiological processes. the ultimate goal is to create new risk/plan/action/outcome connections that facilitate learning opportunities and iterative advancement in treatment and preventative methods for chronic disease. another consideration is the order applied to the interventions including "in series" or "in parallel". an example is diabetes that needs to be managed for the prevention of heart disease, yet these diseases lie in different medical silos. the final objective ensures that workup of any individual patient, regardless of the presumed scope of the illness, embraces all possible causal factors. the purpose of this study was to assess the effectiveness and safety of this novel care model for the prevention and reversal of a broad spectrum of chronic diseases and complaints over a nine-month period. primary endpoints to assess the effectiveness of the intervention were changes in health risk assessment scoring, changes in documented health complaints, changes in medication usage, changes in vital signs, changes to individual blood-based biomarkers designed to measure chronic health, and changes to the multiple marker risk score, the cdt. we conducted an open-label, randomized, controlled, before-and-after nine-month study of a high intensity remote and on-site care intervention named a health revival process (hrp). participants included a group of individuals who, at the time, were employed by a mid-west fortune , manufacturing company with approximately , employees at that site. no formal control group was established but non-participant health status over the period was tracked using claims data for diagnoses, complaints, medication use, and healthcare spending. participation was voluntary and recruitment started in november of , implemented by our company and the employer, focused on higher claims and more chronically sick individuals who were motivated to overcome unresolved chronic health issues. no rigid participation inclusion criteria were used other than each individual had at least one diagnosed chronic condition, was formerly or currently on a medication for a chronic disease, and was a high healthcare claimant (> $ /year currently or within the past three years) if that data was available. not all participants had claims data from previous years mainly due to their health plan and choice or employment history with the company. from those interested in the program and met the criteria, retrospective health data (medical claims) were reconciled to finalize the -person cohort without consideration for a specific type of condition. although not a formal clinical study, all procedures performed in the program involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the helsinki declaration and its later amendments or comparable ethical standards. ethical oversight was provided by the existing primary care clinic management organization, but not under any formal written agreement other than to monitor for patient safety. informed consent, medical releases, and participation contracts were obtained from all participants included in the program. these documents were completed after each participant was provided detailed information about the program. all data were acquired in strict conformance with health data privacy laws by medical personnel and all stored data were contained on a health insurance portability and accountability act (hipaa) compliant cloud. the health revival process: participants in the health revival process (hrp) underwent medical history review, completed a +/-question online health risk assessment (chronic disease assessment™ (cda)) and laboratory testing for serum-based biomarkers (chronic disease temperature™ (cdt)). participants without a medical exam within the past months had one perform by our doctor, to determine their baseline health and risk status. all data obtained on participants, including problems, diagnoses, health complaints, reconciled medications, vitals, food journal, and other measurements were entered into our proprietary health revival software. upon qualifying, hrp participants began one-on-one health coaching encounters. the initial coaching session included active listening by the coach and reconciliation between the output of the cda risk assessment and health concerns, problems, and information articulated by the participant at that first encounter. any discrepancy between the responses to the cda questions and information presented to the health coach were verified and the cda was appropriate updated and annotated. the health coach, using the recommendations promoted by the up-to-date hrp software record, developed a personalized health roadmap referred to as a person's health revival care plan™ (hrcp). our medical doctor reviewed and finalized that document and then conferred with the coach on next steps appropriate for the participant. our doctor and the non-hrp medical doctors ensured that the recommendations and suggestions made by the health coach did not violate the health coaches license to provide advice. there was reasonable fidelity to the hrp delivery as everyone saw the same coach and doctor over the same time period. however, participants experienced different levels of coaching and doctor intensity based on the extent of their risk portfolio and medical needs. participants had continuous access to their health information, suggestions, and progress within the hrp software which maintained much of their personal health information. specifically, a participant could follow, track, and monitor changes in health measures and interact with specific, personalized content (written, audio, and video) curated automatically by the hrp system based on their personalized health information inputs including, their cda risk assessment, cdt markers, and vital signs recorded in the system. in addition, the participant portal included their personalized hrcp that created the structure for their hrp. participants were able to work with their health coach on the plan, follow the plan through a selfguided process, or some hybrid between the two paths. the health coach was able to monitor the self-guided process through system feedback that included reports on system logins and completed "actions" and "goals." completed actions occurred after a participant accessed content relevant to a health risk determined by the hrcp and choose a selection after reviewing the information like "completed" or "deferred." most participants relied on the health coach for structure, direction, and motivation. figure shows features of the patient portal health revival dashboard. participants in the hrp retained their existing providers for acute disease management and routine medical checkups. care coordination between existing providers and hrp care team occurred as needed. in particular, the hrp doctor and pcp discussed any possible interactions between supplements, lifestyle changes, and current medications. of frequent concern was a need to change the dose or use of insulin, other diabetic medications, blood pressure, cholesterol, and corticosteroid medications as the participant's health improved through lifestyle modification. frequency and type of biomarker tracking, beyond the before-and-after cdt labs, were individualized by the hrp doctor on the basis of care needs and progress as recorded by participants in updated cdas and health coaches in updated hrcps and coaching notes. participants on insulin were contacted at least weekly to assess any potential for hypoglycemia. either the pcp or the hrp doctor made medication modifications. chronic disease assessment: the cda was available electronically through a web browser and included +/-questions through a series of shorter surveys, with the participant able to stop and restart the survey at any point where they left off. each question included fixed answer choices from a single option to as many as options depending upon the scope of the question. in some instances, a question allowed for multiple answer selections while in others, only a single response could be recorded. each question/answer combination was given a risk score and assigned one or more attributes of risk based on our study of the medical literature for potential outcomes associated with the specific behavior attribute. the cda included consideration of common risks and disease root causes determined from our own clinical experience and published clinical case studies, population and randomized clinical trials. for example, the cda gave considered to oral health, gut health, eye health status, macro-and micronutrient imbalances, and indications of chronic and occult infection. the output of the cda was a raw score that converted to a letter "grade" reflecting the extent of the risk "portfolio" determined by the assessment. each letter grade, a-f, spanned a range of raw scores. the purpose of the letter grade was to convert a numeric value into a more meaningful and recognizable risk level. in addition, the software interface outputted an action or a series of actions for many of the question/answer pairs, through if/then/else logic. the actions are those known or believed to lead to a reduction in that risk based on peer-reviewed published studies or our own experience. the actions are bundles of content that explain the risk or potential risks and offer suggestions to ameliorate the risk. all this content was made available to participants through their health revival dashboard (hrd). example questions from the cda are provided in figure . chronic disease temperature: routine labs and the cdt biomarker panel were drawn at the on-site clinic by non-hrp technicians working for the primary care provider company. the labs drawn on each individual and the thresholds for chronic health considerations are described elsewhere [ ] . in summary, reference intervals were not used to determine health status and risk. instead, our team of biostatisticians reviewed the medical literature to determine the threshold level or levels for each biomarker, they indicated a statistically significant increase in early mortality associated with that marker. each marker was assigned escalating risk based on log-linear curve fitting to published information on mortality risk and biomarker raw value. many of the cdt biomarkers are common biomarkers with some being less commonly obtained in usual care. the ordering doctor of record was held responsible for ensuring any participant with an abnormal lab value, based on usual care reference intervals, notified the participant and arranged for appropriate care to correct the abnormal value. the "tighter" thresholds used as part of the cdt labs were used only by the hrp doctor and not used for making a medical diagnosis. instead, this more sensitive scale of normal vs abnormal lab values was used to measure changes in participant's physiology concomitant with lifestyle changes. this more sensitive scale for each biomarker and the overall cdt value, helped assess participant's health trends by recognizing that disease is not an on/off switch, but rather a continuum. for example, and hba c level of . %, although not a diagnosis for type diabetes, is a strong indicator of future type diabetes. a goal value of < . % was established for all participants to optimize insulin sensitivity and avoid future diabetes risk, assuming that value was obtained through lifestyle improvement and not pharmaceutical intervention. this logic was applied to all cdt markers. the interventions affected by the hrp through the hrcp were individualized to each participant and included a consideration of the participant's readiness to change and the likely sustainability of any given change as determined by their responses to chronic disease assessment questions and discussions with their health coach. the intensity of coaching was predetermined, but not fixed, by the cda grade. the coaching time allotted to each participant based on the cda grade is provided in table . doctor time allocation was approximately / th coaching time. the main risk considerations were a reduction in inflammation through: more movement, increased nutrient density of foods, improvement in digestion/absorption by improving gut balance and activity, increasing probiotic and prebiotics foods, elimination of high glycemic foods, better oral health maintenance, increased intake of healthy fats and omega- fatty acids, increased micronutrients to support hormone production, stress reduction, brain health through reducing whole-body inflammation, and consumption of greater amounts of fat-soluble vitamins, as examples. no specific nutrition program was recommended to the participants as a whole. instead a simple process of substitution of one food, considered of low nutrient value for another of higher value, was made as recommended by the health coach. recommendations were made on an individualized basis based on participant preferences, to affect a gradual and sustainable change from the standard american diet (sad) that was prolific throughout the cohort, to a new food consumption pattern with increased micronutrient density, fiber, and fat with less carbohydrate and sugar consumption. short term (one to three months) nutritional ketosis was suggested for a few highly insulin resistant and diabetic patients but no participants fully achieved nutritional ketosis during the nine-month period. however, these participants achieved a significant reduction in total carbohydrate consumption with a shift to low glycemic index food and those containing higher concentrations of marine, monounsaturated, and saturated fats. supplements were provided as part of the program and compliance with supplementation was near % based on self-reporting and resupply orders. at the outset of the program, after evaluation of cdt labs, cda reported dietary information, and food journals, the participants were provided any or all of the following supplements based on individually assessed deficiencies: multivitamin/mineral ( qd); vitamin d ( - , iu, qd); cod liver oil ( - g, qd); magnesium glycinate ( - mg, qd); vitamin k ( mcg, qd); probiotic ( - billion organisms, qd). supplements were provided only when deemed appropriate by the hrp doctor and were phased in then phased out over the nine-month period as the doctor determine that nutritional deficiencies or insufficiencies were being mitigated by the program. the purpose of the supplements was to quickly overcome apparent nutritional deficiencies. as part of the hrcp, foods that contained nutrients provided by the supplements were recommended and, when adopted, enabled the gradual elimination of supplementation without compromising nutritional needs. the main behavioral change strategy, executed by the doctor and coach care team, was to slowly and gradually ease a participant into change. the frequency of coaching sessions, dictated by the need of the participant (cda letter grade), including their burden or disease and risk, and their motivation, was adjusted to improve compliance. most participants suffered from some health ailment that impacted their daily wellbeing. improvement in general wellbeing, which started to be noticed by participants by the end of month , provided the motivation to continue to adopt gradual modifications to lifestyle. to help participants understand that the hrp is not a quick fix, our coaches explained that we have determined a general "rule of thumb" for the time required to improve health significantly. if a disease, like diabetes, has been slowly developing over five years, it will take at least five months of effort to reverse the disease, assuming the interventions are appropriate. outcome measures: in-clinic vital signs, health risk assessment (cda) risk score and list, and biomarkers were obtained at baseline and at the end of the -month program. problems, complaints and medications were reconciled at each health coaching and doctor encounter. fasted and non-fasted blood draws were obtained by clinic pcp staff using routine procedures. samples were provided to and analyzed by quest diagnostics using standard operating procedures. primary outcomes were: changes in biomarker values; risk scores; reported diagnoses; vital signs; weight; and medication use. secondary outcomes included reported complaints, for example, lack of energy, chronic pain, sleeplessness, mood issues, and general lack of wellbeing. the baseline demographics of the final hrp participants are presented in table . all participants were caucasian of european heritage. at baseline, % of hrp participants were actively taking pharmaceuticals for a medical problem and % were diagnosed with at least chronic condition. this reflects a substantially higher percentage of chronically ill individuals compared to the u.s. national average of % of u.s. adults having at least one chronic condition. on average, the group was taking . prescriptions per person. the major class of medications included: diabetes medications, injectable insulin, statins, blood pressure lowering, pain, mood (ssris), bisphosphonates, steroids, thyroid hormone, and proton pump inhibitors. the final participant number of was established after left the program. two were dismissed from the program for compliance reasons, four left early to join a weight loss program, two left because of the time commitment, and two left due to potential interactions between current medications and supplements as encouraged by their pcp, for a total of . %. there was no clear demographic trend between those who remained in the program versus those who dropped out. chronic disease assessment™ (cda): on average, the -participant cohort lowered their cda score by points ( %) from a raw value of to a new value of over six months. each point lowered reflected a reduction in a disease risk or resolution of a health problem or complaint. risks were scored on a - scale, with representing a minor risk or problem and representing a major risk or problem. the initial population cda grade was d+, assigned based on a range of raw numeric scores calculated from the survey, and the final grade after months of the hrp was c+. ninety-four percent of the group experienced an improvement in their risks while % of the cohort experienced a worsening of their cda grade ( figure ) . participants did not have their initial cda answers to refer to when they retook the assessment six months into the program. chronic disease temperature™ (cdt): on average, the -participant cohort lowered their cdt score from . to . . the cdt is based on a "degree" scale calculated by adding the risk contribution from each biomarker to . to arrive at the participant's cdt. the average chronic disease risk reduction in cdt was % (figure ). all % of participants whose cda grade worsened also experienced an adverse change in their cdt score. three participants improved their reported cda grade but witnessed an adverse change in their cdt. the cdt included several markers that are classified as "acute phase" reactants. in "acute-phase proteins and other systemic responses to inflammation," the authors explain that markers of chronic systemic inflammation are also subject to change acutely [ ] . for example, c-reactive protein elevates during the acute phase of pneumococcal pneumonia. c-reactive protein has an acute phase relaxation half-life of approximately one day upon removal of the insult whereas the half-life of fibrinogen is about one week. two of the three participants with an improved cda but worsened cdt experienced adverse physiological changes due to documented acute circumstances. retest was not available during the nine-month program to confirm our suspicion about the cause of the elevation. one recently underwent surgery and was recovering slowly. another participant was receiving ongoing treatment for a complex acute condition managed by the patient's pcp. other participants whose cdt worsened were in the hrp and a calorie-restricting weight loss program administered by third parties. the weight loss program was calorie counting-based with no guidance provided on macro and micronutrients. these individuals, although in the hcp, were less flexible to our coach's dietary suggestions because of the calorie restriction. for example, a participant refused to take cod liver oil because each capsule contributed approximately calories to their daily calorie allotment. our results demonstrated, in this small subgroup, that people in poor health and with a highly elevated cdt, confirming their health status objectively, may be contraindicated for a sustained calorie restriction program without nutritional guidance. although the literature is rich in studies suggesting that calorie restriction improves lifespan and reduces inflammatory markers, emerging studies emphasize that calorie restriction must be implemented without malnutrition that comes from low nutrient-dense foods processed foods. macro-and micronutrient intake of all participants was monitored with a food journal. worsening in cdt markers in people on a calorie-restricted diet correlated to micronutrient malnutrition exacerbated by reduced total calorie intake. malnutrition status was established in these individuals by determining their daily nutrient recommendation from the dri calculator for healthcare professionals provided by the usda and comparing the results to nutrients consumed based on available nutritional labels for foods consumed. there are numerous studies on the association between lifestyle behaviors and chronic disease risk. in large prospective studies, like the nurses' health study, vague conclusions are made about the association of smoking, regular physical activity, maintaining normal body mass index, eating a healthy diet and chronic disease proliferation [ ] . the individualized cda risk values potentially increase the precision, personalization, and accuracy of risk-to-disease relationship measurement. figure provides a view of the change in the cda risk score and its relationship to the cdt value for the biomarker panel at the beginning and end of the -month hrp program for the entire population. the same data are presented in figure as bubble chart with the before and after data superimposed on the same scale. temperature score) before and after six months of the hrp program notable is the reasonably smooth relationship between the two risks scores, the subjective cda and the more objective cdt. we conclude, from these data, reducing the most basic health risks, over time, may lead to a reduction in cytokine burden with often concomitant change in diagnosed chronic diseases. increasing the "n" in our database and making appropriate adjustments to assigned subjective risk values within the algorithm offers the potential to improve the correlation between determinants of health risks and physiological health status. the individualized statistics for the cda, cdt, and biomarkers comprising the cdt to evaluate participants health and risk are provided in table . score mean before mean after mean difference standard deviation t test value cdt is the chronic disease temperature biomarker score as a relative value with . considered optimal and elevated values indicating chronic risk; hba c is expressed as a %; glucose is expressed as mg/dl; nlr is the neutrophil to lymphocyte ratio; hs-crp is high sensitivity c-reactive protein or c-reactive protein, cardiac expressed as mg/l; insulin is expressed as uiu/ml; hdl is expressed as mg/dl; triglycerides are expressed as mg/dl; vitamin d is expressed as ng/ml; uric acid is expressed as mg/dl; wbc is the white blood cell count expressed as cells/ul; rdw is the red blood cell distribution width expresses as a %; ab neutrophils are neutrophils (absolute) expressed as cells/ul; esr is the sedimentation rate-westergren expressed in mm/hr; fibrinogen is fibrinogen activity expressed as mg/dl; homocysteine is expressed as umol/l; and aip is the atherogenic index of plasma expressed as the log(triglycerides/hdl) glycosylated hemoglobin (a c): a c, a -day retrospective average of blood glucose, contributes to an assessment of metabolic risk along with fasting glucose and insulin. a current therapeutic goal in usual care is to lower the a c value of diabetics, those with a c values above . %, with pharmaceuticals. the accord study shows that tight pharmaceutical control of blood sugar in those with severe insulin resistance suffer a significant increase in adverse cardiovascular events and mortality compared to those with less tight control [ ] . lifestyle interventions offer another approach to glycemic control and does so without risk of hypoglycemia and other side effects of the pharmaceutical approach. in the cohort of , none had optimal a c levels, defined as . %- . %. even a . % increase in a c above % increases the year risk for diabetes (odds ratio > . ) and the risk of diabetes increases exponentially with a c. in the participant cohort, at the end of the hrp, % (all but ) lowered their a c value ( insulin is the most sensitive marker for early metabolic risk because it increases first as an individual becomes insulin resistant. even values slightly above normal, and well below a diagnosis of diabetes, contribute to serious chronic diseases in the future, including alzheimer's and cardiovascular disease. type diabetes is associated with increased risk of cancer. hyperinsulinemia (elevated insulin levels) and insulin resistance are apparently the link. in a -year mortality study, individuals in the highest quintile of serum insulin had a % higher risk of cancer mortality and a % higher risk of gastrointestinal cancer mortality [ ] . the authors of this study concluded that hyperinsulinemia/insulin resistance is associated with cancer mortality independently of diabetes, obesity/visceral obesity and metabolic syndrome. in the -person cohort, participants ( %) were at elevated metabolic and associated chronic risk. six of the ( %) experienced a double digit drop in fasting insulin, of ( %) dropped from the high-risk category to a lower risk level, ( %) lowered insulin levels sufficiently to reduce their cancer risk severity category, ( %) changed little and stayed in the same risk category and move up one risk category ( [ ] . in the -person cohort, % of participants who were at high risk for cardiovascular disease, based on hs-crp level > , lowered that risk ( table ) . [ ] . the aip average value before the hrp was . and lowered to . at the end of the hrp. conventionally the rdw test, which is a part of a complete blood count, is used to help determine anemia status. however, it is also a marker of inflammation and often tracks with crp. red blood cells elongate and deform when flowing through capillaries, which may explain the association between red blood cell widths, vascular inflammation, and increased cardiovascular morbidity and mortality. in the -person cohort, % of participants at elevated risk for cardiovascular disease based on rdw levels lowered their risk ( table ) . white blood cell counts (wbc) is a predictor of strokes, heart attacks, and fatal heart disease. in the women's health initiative involving , women from - years of age, those with approximately , white cells per ml had more than double the risk of fatal heart disease than women with cells per ml [ ] . white blood cell counts in the normal range for acute indications are now more widely recognized as a predictor of adverse chronic outcomes. in the -person cohort, three individuals had high cardiovascular disease risk based on wbc levels, and % lowered that risk through lifestyle modifications. in addition, % of those with moderate risk moved to either low or very low risk as assessed by risk quartiles for wbc. in general, % of participants moved from a high to a lower risk status ( table ) . multiple studies show a significant inverse relationship between -hydroxy vitamin d (d ) status and cancer mortality. in a fifteen-year study of nearly , participants, an increment increase of ng/ml was associated with a % reduction in total cancer incidence, % reduction in total cancer mortality and statistically significant reductions in colorectal, pancreatic, esophageal, oral, and pharyngeal cancer mortality [ ] . for cancer, optimal d levels are above ng/ml. at the start of the program, eight participants had optimal levels and that number increased to by the end of the program. insufficient vitamin d, as defined for bone health are values below ng/ml. initially there were participants insufficient for blood d and none were insufficient at the end of the program. the population d levels went from to ng/ml, on average, by the end of the hrp. these data indicate a high degree of compliance with the program recommendations as the increase in d status was largely attributable to consistent supplementation. in general, the increase observed required daily supplementation of iu d daily ( table ). the neutrophil-to-lymphocyte ratio (nlr) is reported to be a robust outcome prognosticator in existing solid tumor cancers. in a study on breast cancer, patients with an nlr > . had substantially higher oneyear and five-year mortality rates compared to those with an nlr < . . the nlr value has similar predictive ability for cardiovascular mortality [ ] . in the cohort of , had nlr above the threshold for adverse cancer outcomes. sixteen of ( %) saw their nlr ratios return to very low risk (normal values) by the end of the program ( and associated changes to cancer and cardiovascular mortality prognosis medication prescription reduction was achieved as part of the outcome measurement. the cohort experienced a % reduction in medication usage, reduction in dose in %, and an avoidance of two costly medications. the prices included in table , below, where the actual pharmacy costs realized by the health plan and did not include any co-pay. the cohort experienced a reduction in chronic disease burden. chronic disease reduction was determined by changes in any of the following: actual change to a medical diagnosis, elimination of a medication associated with an existing diagnosis, changes in a vital sign that indicated a migration out of a diagnosis that was affected without the use of a medication, or change in a biomarker value or values that were initially used to make the diagnosis into a "normal" range without the use of medications (table ) . this participant presented with major risk factors and complaints including lack or exercise, fast food diet, high carbohydrate diet, daily high fructose corn syrup containing beverage consumption, use of omega- containing oils in cooking, statin drug daily prescription for primary cardiac event prevention, severe arthritis, psoriasis, and cataract. the severity of the psoriasis and her job function put her at risk of imminently going on disability. she had seen multiple specialists, was placed on antihistamines and topical steroids but her psoriasis condition continued to worsen. the next treatment option for her was to be etanercept which she declined pending the outcome from the hrp. she indicated that she had not washed her hands without pain in over a year. the hrp included -minute semi-monthly health revival coaching following the participant and care team agreed upon care plan. cholesterol-lowering drug usage was eliminated in the first month as directed by our medical director. health coaching focused mainly on food substitutions, increasing activity, value and use of supplements, a limited set of supplements, and additional care to her oral hygiene. after six months of intensive health revival coaching, many risk factors and complaints, revealed on her cda report, were either removed or reduced including nagging chronic pain. her main complaint, debilitating psoriasis slowly, but completed resolved in five months ( figure ) . however, the first signs of improvement in her psoriasis condition did not appear until month of the program. normally, in the case of autoimmune diseases like psoriasis, food sensitivities or allergies must be addressed. this participant was unwilling to eliminate some of the common allergens like gluten and dairy. she was placed on a modest supplement regiment based on nutritional deficiencies determined from food journaling, including: cod liver oil ( g/day); vitamin d ( , iu/day) and a multivitamin/mineral supplement (taken per label instruction), and the other general supplements included in the "methods" section. positive changes in lab values included: -hydroxy vitamin d status ( to ng/ml); white blood cell counts ( , to , ) ; rdw ( . % to . %); and fibrinogen ( to mg/dl). case : rheumatoid arthritis and type diabetes - -year-old male factory worker with a high school education (table ) . over the first five months, the participant lost pounds through a reduction in carbohydrate consumption, but with no significant change in daily calorie intake. the participant embarked on a substitution diet where, over five months, gluten-containing foods were removed from his diet and replaced with vegetables and marine-and animal-based fats. he was also put on a modest supplementation program including cod liver oil ( g/day); vitamin d ( iu/day); magnesium glycinate ( mg/day); vitamin k ( mcg/day) and a multivitamin/mineral (per label instruction). his type diabetes was reversed as illustrated by his a c dropping from . % to . % and his fasting glucose dropping from to < mg/dl. his pain was substantially eliminated, based on a subjective pain score of / initially, to / . his ra improved to enable him to be able to bend his fingers into a full fist for the first time in over five years (figure ). this participant reported with a severe autoimmune disease, polychondritis, that produced monthly painful flares in cartilage above her shoulders including her ears and eyes. long-term use of steroidal antiinflammatories were implicated in the cataracts and a breast lump that was removed surgically. the cataracts had progressed sufficiently to cause her to be on disability and be unable to drive a car. cataract surgery was not an option due to the severity and unpredictability of eye flares that could cause extremely adverse outcomes if they coincided with surgery. she had seen several specialists including local rheumatologists, natural doctors, and doctors from cleveland clinic with no relief to her condition. she had researched polychondritis on her own, prior to joining this program and eliminated gluten and dairy from her diet but this change did not alter the disease severity or frequency. this participant had made significant changes in her lifestyle prior to this program as reflected in her cda grade, but these changes were insufficient to improve her blood biomarkers indicated by the high cdt value of . , indicative of serious health risk and poor prognosis. our health revival process guided her to continued better choices and involved semi-monthly -minute lifestyle coaching. the main changes made over a six-month period included: increasing healthy fats, reducing carbohydrate intake, increasing micronutrient density, stopping nicotine dependence, improving digestive health with optimizing food choices including increasing stomach acid status, and repopulating gut microflora. at month in the program, her eye and ear flares had subsided sufficiently to allow for a meaningful reduction in eye and oral steroids, ( mg/day to mg/day prednisone). in addition, she was able to have successful cataract surgery which enable her to start driving again, and return to work, both of which were curtailed over one year. the polychondritis may never be cured, however, with appropriate lifestyle management, it is no longer impacting her quality of life. prevention and reversal of chronic and non-communicable diseases continue to be a largely unmet need. a fresh approach is clearly warranted to curb this global scourge. one impediment is the lack of precision and personalization of risk with "poor diet" as an example. and there is a lack of measurement of a broad array of minor, yet important, risks that can easily be overcome. the same suite of risks is continually presented to individuals who historically have not been able to modify or overcome them, with smoking or alcohol consumption as examples. according to khullar in, "we're bad at evaluating risk, how doctors can help," a broader approach involves helping patients systematically identify what's important to them, and based on these goals and preferences, suggesting to them how to think about their options [ ] . this logic is best applied across the entire time-line that defines the slow and insidious development of chronic disease. it starts with lifestyle decisions and habit development early in life that perpetuate into mid-life and then into old age. measurement and a proper medical "workup" regardless of presumed health status is a key strategy and potential motivating factor that is currently lacking. changes in chronic disease biomarkers in asymptomatic people may afford an early warning sign of stealth changes to which many may respond. pathology changes, identified with advanced diagnostics, which generally develop after a long incubation period detectable with proper biomarker evaluation, may facilitate change in the more recalcitrant. each individual has their own motivations. thus, providing patients with an array of choices and recommendations along the health/disease continuum has a higher probability of inciting action and improving outcomes or preventative actions. this study evaluated a new population risk and health assessment and mitigation system where measurements of risk and disease were made across the disease continuum by using finely tuned biomarkers and risk assessment. the output was a broad-reaching care plan assembled through integration of current health survey results, biomarkers, problems, complaints, medications, vital signs, verbal input from the participant to the health coach, and contributions from the care team. the remediation path to improved health developed as a consensus between the participant and care team, of agreed upon steps and actions, that were malleable as the process moved forward. adjustments were made based on participant preferences, success and failures, a solid health data. according to khullar, "patients need to understand their values but also their possible futures. the idea is not to reduce uncertainty, but to help patients clearly envision what life would look like in one outcome versus another, and to better prepare them for the various futures that might unfold." this program was designed to give participants options beyond the management of disease once it has struck. and it included regular monitoring and concomitant course adjustments to help participants attain their goals. this study prospectively observed adults with chronic conditions and unresolved health complaints that remained unresolved under usual care management and treatment. following six months of hrp, participants achieved subjective and objective improvement in health status with % seeing a reduction in multiple blood-based biomarkers and % achieving a reduction is a broad measure of determinants of health risk factors. concurrently participants reported weight loss ( % of the total and % of those with a reported weight loss goal), reduction in reported pain, sleeplessness, memory issues, heartburn, skin rashes, migraines, and daily fatigue. the diabetics in the program had all progressively worsen over the previous two years, as measured by fasting glucose, hba c, and medication usage and all improved under the hrp program. hrp meaningfully improved hba c, fasting insulin, neutrophil-to-lymphocyte ratio, hs-crp, vitamin d, white blood cell counts, red blood cell distribution width, absolute neutrophils -all part of the cdt panel. in addition, hdl, fasting glucose, triglycerides, gfr, atherogenic index of plasma (aip) liver enzymes, and blood pressure improved is most participants with initial abnormal values. aip is emerging as a valuable representation of increased mortality risk. improvement in this lab value ratio was consistent with previous studies using carbohydrate-restricted interventions. however, although the hrp included some level of carbohydrate restriction, this was not a mandate and carbohydrate consumption goals were not set. instead, participants were afforded broader options that met each at their level of readiness to change and did not overwhelm anyone with unachievable objectives. in general, small swap-out suggestions were agreed upon at each encounter. the "pure" study reports are a set of studies that describe components of the nutritional approach used in the hrp. in "fruit, vegetable, and legume intake, and cardiovascular disease and deaths in countries (pure): a prospective cohort study," fruit, vegetable and legume consumption recommendations were - g/day to achieve maximum benefit at reducing non-cardiovascular and total mortality [ ] . the hrp coaches encouraged consumption of three to four servings of these foods per day, focusing on lowest glycemic index choices. in "associations of fats and carbohydrate intake with cardiovascular disease and mortality in countries from five continents (pure): a prospective cohort study," healthy fats were found to be indicated for a reduction of total mortality risk and saturated fats were shown to be inversely associated to stroke risk. the hrp coaches guided participants to swap out carbs, sugars, and some protein in favor of healthy fats in foods and cooking oils with emphasis on increasing saturated, mono-saturated, and marine fats. obtaining nutritional ketosis for a two to three months window was suggested for all the diagnosed type diabetics; however, none achieved sustained ketosis but their metabolic markers indicated improvement of their diabetic conditions during the -month hrp. this suggested that the broader, more personalized risk reduction approach of this hrp, compared to strict carbohydrate restriction, affords metabolic profile results without the potential risks associated with carbohydrate starvation in insulinresistant subjects. reducing whole body inflammation was the primary objective of each encounter, not just reducing the glycemic value of food. examples included switching out proinflammatory for anti-inflammatory cooking oils, lowering glycemic value and load of substituted foods, reducing frequency of fast food consumption, improving oral hygiene, managing stress, establishing better sleep and rest patterns, enhancing hydration, improving micronutrient density of foods consumed, establishing more frequent movement routines, and consuming more gut-supporting foods. the regular health coach encounters that included reviewing risk factors, vitals, and medication usage, with doctor supervision, may have provided behavior reinforcement. further, it is plausible that this multi-risk amelioration care model allowed from both broader and greater adoption and improvements compared to interventions focused on fewer factors. in this hrp we effectively leveraged credible measurement and evaluation, linked these findings to participant's unresolved and nagging health complaints, and facilitated behavioral change leading to health improvement in most participants. the program did not rely only on usual care measures of health. participants were not confronted with high hurdles to health improvement that often discourage engagement. instead, the program centered around meeting a person at their level of readiness and capitalizing on small triumphs that eventually led to measurable health improvements recognized by the individual that led to a cycle of improvement rather than deterioration. no episodes of adverse events were attributable to the hrp. one insulin-dependent type diabetic participant showed a sudden increase in fasting insulin, from . to μu/ml, which was reported to his pcp for medication adjustment. several participants reported dizziness and either the hrp or pcp lowered their blood pressure medication dose that, in all cases, resolved the complaint. prior studies have demonstrated favorable cost reductions in broad-based wellness and disease management programs. most of the cost-saving and health maintenance were attributed to the management of existing disease rather than prevention and required a strong evidence-based approach. a strength of this hrp was an emphasis on root-causes of and reversal of disease rather than just case management. additionally, this study reflected a real-world workplace environment with a distribution of both white-and blue-collar workers participating and with a range of diseases and aliments. weaknesses included a lack of a representative control group, single location and participants were mostly caucasian. the study was not of sufficient size and duration to measure hard endpoints including mortality and adverse health events. future studies of this nature could include multisite randomized controlled trials with greater racial and ethnic diversity, and longer duration. this highly personalized and scalable health revival study protocol demonstrated that a broad array of chronic health complaints and problems can be controlled and reversed by methodically eliminating seemingly small lifestyle-induced health risks. it also demonstrated that the lifestyle risk tool, the chronic disease assessment™, and the biomarker panel, the chronic disease temperature™, that were used to develop care plans, changed in correspondence with participant-and medical staff-reported health improvements. therefore, these tools may be valuable for the measurement and mitigation of chronic disease risk and chronic diseases generally. importantly, the implementation of this program is low cost, using inexpensive on-line survey tools, biomarkers, and health coaching. additionally, this program is well suited to be implemented in large populations through surveying, obtaining labs through national networks, and performing group coaching sessions based on common risks identified through the risk assessment tool. more studies using this overall hrp approach are required to validate the measurement methods, processes, and outcomes. this approach offers a potentially important health delivery modality in a world with escalating chronic disease morbidity and mortality. acquired in strict conformance with health data privacy laws by medical personnel and stored and managed in a hipaa compliant emr. animal subjects: all authors have confirmed that this study did not involve animal subjects or tissue. conflicts of interest: in compliance with the icmje uniform disclosure form, all authors declare the following: payment/services info: all authors have declared that no financial support was received from any organization for the submitted work. financial relationships: all authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. other relationships: all authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. global status report on noncommunicable diseases. world health organization (ed): world health organization the us health disadvantage relative to other high-income countries: findings from a national research council/ institute of medicine report heart disease strikes back across the u.s even in healthy places multiple chronic conditions in the united states consistently high turnover in the group of top health care spenders the cytokine storm and pre-cytokine storm status in covid- -a model for managing population risk for pandemics and chronic diseases association between platelet parameters and mortality in coronavirus disease : retrospective cohort study. platelets. disease control priorities in developing countries. nd edition. the international bank for reconstruction and development/the world bank global, regional, and national comparative risk assessment of behavioural, environmental and occupational, and metabolic risks or clusters of risks, - : a systematic analysis for the global burden of disease study effects of health literacy on health status and health service utilization amongst the elderly is patient activation associated with future health outcomes and healthcare utilization among patients with diabetes lipid levels in patients hospitalized with coronary artery disease: an analysis of , hospitalizations in get with the guidelines use of framingham risk score and new biomarkers to predict cardiovascular mortality in older people: population based observational cohort study stress and the individual: mechanisms leading to disease . arch internal med network theory of aging meeting physical activity guidelines is associated with lower allostatic load and inflammation in mexican americans multiple biomarkers for the prediction of first major cardiovascular events and death atherogenic index of plasma and triglyceride/high-density lipoprotein cholesterol ratio predict mortality risk better than individual cholesterol risk factors, among an older adult population quarterback your own health -how to take and lower your chronic disease temperature acute-phase proteins and other systemic responses to inflammation diet, lifestyle, biomarkers, genetic factors, and risk of cardiovascular disease in the nurses' health studies the association between symptomatic, severe hypoglycaemia and mortality in type diabetes: retrospective epidemiological analysis of the accord study insulin resistance/hyperinsulinemia and cancer mortality: the cremona study at the th year of follow-up rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity c-reactive protein: rationale and design of the jupiter trial leukocyte count as a predictor of cardiovascular events and mortality in postmenopausal women: the women's health initiative observational study prospective study of predictors of vitamin d status and cancer incidence and mortality in men the predictive value of elevated neutrophil to lymphocyte ratio for long-term cardiovascular mortality in peripheral arterial occlusive disease we're bad at evaluating risk. how doctors can help . the new york times fruit, vegetable, and legume intake, and cardiovascular disease and deaths in countries (pure): a prospective cohort study the authors thank the invaluable assistance of dr. michael l. carter, dr. trent austin, and jasmin lewis human subjects: consent was obtained by all participants in this study. neco irb issued approval t.the neco irb has approved this study as it was conducted in conjunction with routine clinical practice. all procedures performed in the program involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the helsinki declaration and its later amendments or comparable ethical standards. ethical oversight was provided by the existing primary care doctors who were not part of the program. informed consent, medical releases, and participation contracts were obtained from all participants included in the program. these documents were completed after each participant was provided detailed information about the program. all data was key: cord- -of ogow authors: morley, georgina; grady, christine; mccarthy, joan; ulrich, connie m. title: covid‐ : ethical challenges for nurses date: - - journal: hastings cent rep doi: . /hast. sha: doc_id: cord_uid: of ogow the covid‐ pandemic has highlighted many of the difficult ethical issues that health care professionals confront in caring for patients and families. the decisions such workers face on the front lines are fraught with uncertainty for all stakeholders. our focus is on the implications for nurses, who are the largest global health care workforce but whose perspectives are not always fully considered. this essay discusses three overarching ethical issues that create a myriad of concerns and will likely affect nurses globally in unique ways: the safety of nurses, patients, colleagues, and families; the allocation of scarce resources; and the changing nature of nurses' relationships with patients and families. we urge policy‐makers to ensure that nurses' voices and perspectives are integrated into both local and global decision‐making so as to minimize the structural injustices many nurses have faced to date. finally, we urge nurses to seek sources of support throughout this pandemic. t he covid- pandemic-with, at the time of this writing, nearly two million cases worldwide and , deaths -has highlighted many of the difficult ethical issues that health care professionals confront in caring for patients and families. the decisions such workers face on the front lines are fraught with uncertainty for all stakeholders. our focus is on the implications for nurses, who are the largest global health care workforce but whose perspectives are not always fully considered. we see three overarching ethical issues that create a myriad of concerns and will likely affect nurses globally in unique ways: the safety of nurses, patients, colleagues, and families; the allocation of scarce resources; and the changing nature of nurses' relationships with patients and families. i n the battle against covid- , the safety of nurses and other health care workers on the front lines is a pressing ethical concern, as they are asked to work under conditions that pose substantial and inadequately understood risks to their overall health and well-being. risk of exposure to infectious diseases is not new within health care. over the last fifty years, health care workers have encountered risks from hiv/ aids, sars, swine flu, and ebola. while covid- has not yet been as deadly as hiv/aids or the swine flu, our insufficient understanding about the virus, its pathophysiology, mode of transmission, susceptibility profile, and contagious nature as well as failures in the supply chains for personal protective equipment (ppe) mean that health care workers are being asked to take on substantial but uncertain risk. the inadequate protection of health care workers across all health care settings raises professional and ethical ques-tions about the extent of these workers' duty to care for patients-including the limits of that duty. the revised american nurses association code of ethics states that nurses' primary duty is to the recipient of nursing care, whether that be an individual patient, family, or community. the code of ethics also stipulates that nurses have a duty to promote their own health and safety. these multiple and even competing duties, especially as they combine or conflict with civic and personal interests, place nurses-many of whom have conditions that make them more vulnerable to covid-in a quandary. they are trying to balance their obligations of beneficence and duty to care for patients with rights and responsibilities to address inadequacies within their health care systems in ways that are consistent with rights and duties to protect themselves and their loved ones. contemporary nursing ethics scholarship foregrounds the relational dimension of all human activities, especially caring activities, and recognizes that nurses' personal and professional lives are often grounded in interdependent relationships of responsibility and care. applying this relational account of care to current practice realities can help policy-makers and health care system leaders recognize additional risks in nursing work-and the emotional weight and practical implications of those risks. this relational context suggests that nurses' concerns about ppe may arise not just because of concerns for personal safety but also because of concerns about transmitting covid- to loved ones, especially those who have medical conditions that make them particularly vulnerable, or because they may be the sole support for and carer of children or dependent adult relatives. nurses routinely and willingly care for patients in risky situations. however, requiring them to provide care under conditions of inadequate protection (such as lack of ppe) jeopardizes their safety, their loved ones' safety, and their ability to provide longer-term nursing care. nursing in these conditions demands a disproportionate level of altruism and self-sacrifice. employers have a duty to their employees to provide adequate ppe, and any harm that may come to patients through lack of ppe and personnel to safely care for patients is a failure of institutions and systems, not of individuals. if employers provide adequate ppe and appropriate guidance on how to use it, and reasonably address and mitigate the additional foreseen risks that caring for patients with covid- present, then nurses and others will continue to provide patient care that is more aligned with the usual risks that health care workers knowingly take on when they enter their professions. both organizations and health care workers also have a duty to steward resources with care. organizational leaders should provide guidance and support to nurses and other health care providers about when ppe is and is not essential. they should make every effort to supply ppe, encourage its appropriate use, and define expectations for situations where there is a shortage of ppe. organizations should support decisions to delay or deny treatment in those difficult cases when the absence of ppe poses significant risks to nurses and others so that health care workers can fulfill their duty to protect themselves and their duty to patients who need their care. faced with the potential reality that a patient will suffer, clinically deteriorate, or die, many health care professionals will find it extremely difficult to make or implement a decision to deny or delay treatment given their own human response, their professional socialization, and their profession's expectations and norms about saving lives, relieving suffering, and not abandoning patients. in most places, the hope is that rigorous contingency planning and preparation for surging capacity will obviate the need for denying treatment to anyone. nonetheless, taking the time required to don adequate ppe might lead to small delays in patient care such as implementing cardiopulmonary resuscitation and providing aerosol-generating procedures. leadership should reassure health care professionals that doing what is necessary to protect themselves will ultimately save more people and that they are doing the morally and professionally appropriate thing. at the same time, nurses and other health care providers should do everything they can to minimize suffering and to support their colleagues who are able to act safely. the possible effects of these difficult experiences on nurses and other health care workers should not be underestimated. many health care organizations are already taking steps to address moral distress, psychological distress, and post-traumatic stress disorder experienced by their workers; many others need to integrate such support into their responses to the pandemic. t he second key ethical issue concerns the allocation of scarce resources, which demands decision-making in which nurses are inconsistently included. in any health crisis or emergency, nurses prioritize their care goals for patients. covid- has demanded more substantive (and ethical) consideration of how to prioritize care and resources across different settings and units of care. many jurisdictions around the world have established and are prepared to implement, if necessary, crisis standards of care that apply in public health disasters and conditions of scarce resources. crisis standards require modification in the care that can be delivered and shift the balance of ethical concern from the needs of the individual to the needs of the community. triage guidelines use stringent clinical criteria and frameworks-usually developed in advance of public health crises-to guide a health care system's decisions about which patients are most likely to benefit during a crisis from the allocation of, for example, a scarce intensive care unit (icu) bed, invasive ventilation, or extra corporeal membrane oxygenation (ecmo). the intention is to ensure consistency in decision-making during time-pressured emergencies, remove the burden of decision-making from individual bedside providers, and ensure adherence with basic ethical principles such as fairness, transparency, proportionality, and protection for health care workers from legal liability. robert truog and colleagues note that the allocation of ventilators is possibly one of the most difficult triage decisions, yet rationing them may be necessary because coronavirus frequently manifests as acute respiratory distress syndrome. triage guidelines and algorithms are generally created by groups of experts, ideally from different disciplines and with public engagement. some published guidelines and frameworks highlight the need for decisionmaking by a multidisciplinary triage team that includes a nurse leader, whereas others call simply for a triage officer (a senior physician) to make these decisions. even when nurses are not involved in the development of these guidelines, they are frequently responsible for managing these life-sustaining technologies and for implementing triage decisions, including withdrawal. nurses' involvement in the withdrawal and reallocation of ventilator support varies from institution to institution and country to country. "repeat triage" or reallocation is necessary during this pandemic. for example, with a shortage of ventilators, nurses and other clinicians may have to continually reassess the effectiveness of invasive ventilation for particular patients and to reallocate a ventilator from someone whose likelihood of recovery does not meet certain criteria to a patient more likely to benefit. teamwork is essential in addressing critical allocation challenges, and teamwork requires that all voices be heard, especially since providing and withdrawing ventilator support relies heavily on the ability of qualified personnel-specifically, critical care nurses (and, in the united states, respiratory therapists)-to administer this therapy in a way that is actually beneficial. in addition to critical care teams, teams with expertise in palliative care and emotional support are needed when decisions are made to remove life-sustaining treatments. even with the mantra "staff, space, and stuff " within preparedness planning, the need for qualified and trained providers can be overlooked in the bustle of preparedness planning. "staff " are not an infinite resource and are in danger of being pushed and stretched until they break. indeed, due to ppe shortages, many providers who are not nurses are not entering patient rooms, and so nurses (since it is already a necessity that they enter patient rooms) are being relied upon to conduct the roles of others. in addition to assessing patients, nurses are increasingly fulfilling other necessary roles, from witnessing advance directives and setting up virtual communication platforms to cleaning patient rooms and emptying bins. more than ever, nurses are feeling the burden of taking on additional roles and responsibilities. nurse staffing is also a critical concern during a pandemic. while there is a need to be context specific and fluid due to the inability to predict exactly how many nurses might become unwell or need to be quarantined, there is very little guidance regarding optimal or minimum staffing levels for preparation phases, for the initiation of triage, or for adequate provision of crisis care. this creates further uncertainty for nurses, who must be able to meet the needs of patients even if redeployed into unfamiliar areas and roles and even when facilities are understaffed. as with a shortage of beds and life-saving equipment, the lack of qualified nurses and other health care providers (and any relevant specific skill sets, such as ecmo training) ought to trigger the use of triage criteria. critics might argue that in a public health crisis all health care workers will be stretched thin and faced with harrowing choices. our concern is whether nurses are at a significantly higher risk. some have suggested that nurses already disproportionately experience moral-constraint distress (from being unable to carry out what one believes to be a morally appropriate action) and moral-conflict distress (because one feels morally uncertain about the appropriate action). indeed, in many contexts, nurses do not have the same levels of authority to assure adequate staffing, apply triage criteria, or make allocation decisions, even though they are involved in implementing these decisions. in some contexts, nurse-to-patient ratios seem to be completely indeterminate, as they may be left to the "discretion of the [c]linical [l]ead." in england, nurse-to-patient ratios are already a point of heated debate due to a lack of legislated minimum ratios (except in the icu, where ventilated patients are strictly nursed at a one-to-one ratio). during a surge in covid- cases, even protected ratios may have to change given the volume of patients who will need urgent care. a recent document from nhs england suggests that during this pandemic, six icu patients could be cared for by one critical-care nurse with support from two nurses with previous or recent icu experience, two nurses with no critical care experience, and a support team of four auxiliary workers. although these numbers may appear adequate, the level of requisite skill remains questionable, as indeed does whether hospitals will be able to stick to these sug-gested numbers. all of this raises a multitude of both practical clinical questions and ethical questions about what a minimum ratio should be in a public emergency, what care is deemed essential, how and what to prioritize for patients (beyond obvious life-saving interventions) , and at what point we begin to do harm. nurse staffing levels have been shown to affect patient outcomes. it is also not clear how crisis standards of care apply to nursing care and how or for what nurses will remain accountable. in situations such as the covid crisis, nurses should be encouraged to remember that the circumstances are not in their control and to accept that some patients will not survive, even as nurses work to ease their suffering and to save as many as possible. allocation decisions are likely to exacerbate a tension that health professionals experience even in normal circumstances-perceived moral and emotional discomfort when making or implementing a decision to withdraw medical treatment that is contributing to or keeping a patient alive for longer than they would survive without it. health care professionals often intuitively feel that withdrawing treatment is morally more troubling than withholding it; nurses have reported feeling that stopping a life-sustaining treatment or therapy can feel like killing the patient. health care professionals may believe that decisions to stop treatments are more momentous and consequential than decisions not to start them. by contrast, with some notable exceptions, decisions to withhold and withdraw treatment are generally considered morally equivalent by most bioethicists, legal regulations, and international professional guidelines. this "equivalence view" holds that, if withholding a particular treatment for a particular patient is acceptable (for example, because it is not likely to be effective or is burdensome), then, all else being equal, withdrawing the treatment is acceptable (if it turns out to be, or becomes after a time, ineffective or burdensome). the need to repeat triage in order to consider incoming patients who may have a greater chance of recovery is likely to be a cause of moral distress for clinicians. dominic wilkinson et al. propose some strategies that might help health professionals overcome their aversion to withdrawing treatment even when doing so is ethically justified. under normal conditions, strategies of particular relevance to critical care nurses and other health professionals involved in withdrawing life-sustaining interventions include the conditional offer of treatment based on measurable treatment goals and the offer of time-limited treatment trials. these strategies might not, however, be possible in conditions of crisis standards of care. due to the potential resource pressures that covid- presents, the health care community has an obligation to be transparent about these limitations with patients and the community. some authors argue that we should prioritize health care workers for testing, treatments, vaccines, and even triage because, without them, who will be left to provide care? two justifications offered for giving priority to health care professionals are that the workers have instrumental value because they are needed for the health care workforce and that prioritizing them would be an instance of due reciprocity, given the increased level of risk that health care workers expose themselves to. other commentators argue that this prioritization may also incentivize health care workers to continue working in higher-risk environments. yet these arguments raise serious concerns about who would count as a health care worker, why they should have priority over other essential persons at risk, whether it is merely self-serving for health care workers to recommend that they be given higher priority, and whether considerations of priority status differ for treatments than for vaccines, for example. a related concern is that, as jackie leach scully highlights, many triage guidelines already contain a worrying degree of disablism and prejudice toward those with disabilities. bringing conceptions of social worth and utility into resource allocation decisions risks introducing other slippery criteria. n urses have a long history of trust with their patients. however, many ethical issues have altered the nursepatient-family relationship in the context of covid- . a recent hastings center publication highlighted the need for nurses, physicians, and other clinicians to move during a pandemic from a patient-centered to community-focused model of practice and care. nurses have traditionally been motivated by community thinking, and the history of nursing ethics has its roots in a social-justice orientation focused on issues of equity, disenfranchisement, and structural forms of oppression. some of the necessary steps to protect the public in this pandemic have created new and unfamiliar tensions between nurses and patients and their families. during the covid- pandemic, many people are dying in isolation from their loved ones, and end-of-life-conversations are taking place over the telephone or "behind the dehumanizing veil of plastic gowns and respirator masks." the challenge for nurses and other health care workers is to temper these potentially dehumanizing scenarios with imaginative solutions that do not sacrifice compassion and equal respect on the altars of safety and efficiency. the effects of covid- on nurses and other health care workers are likely to be long-lasting. we urge policy-makers to ensure that nurses' voices and perspectives are integrated into both local and global decision-making so as to minimize the structural injustices many nurses have faced to date. finally, we urge nurses to seek sources of support throughout this pandemic. for nurses in north america, many health care systems have integrated clinical ethics consultation services with ethicists able to identify and untangle the complex ethical issues that cause moral distress and help mitigate the negative effects of such distress. other supportive services and colleagues include employee assistance programs, clinical psychologists, chaplaincy services, and mental health hotlines to address psychological distress or other concerns that might arise. the unprecedented cri-sis in which the global community finds itself is a lesson in humanity. nurses bring their expertise, knowledge, and skill sets to the health care system in many ways; today, we see this intrinsic and extrinsic value and must do all we can as public citizens to advocate for all they do for us. we owe them much gratitude and respect. coronavirus resource center state of the world's nursing : investing in education, jobs and leadership american nurses association, code of ethics for nurses with interpretive statements moral distress re-examined: a feminist interpretation of nurses' identities, relationships and responsibilities rapid expert consultation on crisis standard of care for the covid- pandemic the toughest triage-allocating ventilators in a pandemic ethical guidance for disaster response, specifically around crisis standards of care: a systematic review ethical framework for health care institutions responding to novel coronavirus sars-cov- (covid- ), the hastings center who is experiencing what kind of moral distress? distinctions for moving from a narrow to a broad definition of moral distress coronavirus: principles for increasing the nursing workforce in response to exceptional increased demand in adult critical care effects of nurse staffing and nurse education on patient deaths in hospitals with different nurse work environments nursing skill mix in european hospitals: cross-sectional study of the association with mortality, patient ratings, and quality of care moral distress in end of life care are withholding and withdrawing therapy always morally equivalent? withholding and withdrawing life-sustaining treatment: ethically equivalent? finding a way through the ethical and legal maze: withdrawal of medical treatment and euthanasia withdrawal aversion and the equivalence test covid- : how to triage effectively in a pandemic disablism in a time of pandemic: some things don't change ethical framework for health care institutions responding to novel coronavirus sars-cov- (covid- ) heritage ethics: toward a thicker account of nursing ethics palliative care in the time of covid key: cord- -kjuc nqa authors: asiamah, nestor; opuni, frank frimpong; mends-brew, edwin; mensah, samuel worlanyo; mensah, henry kofi; quansah, fidelis title: short-term changes in behaviors resulting from covid- -related social isolation and their influences on mental health in ghana date: - - journal: community ment health j doi: . /s - - - sha: doc_id: cord_uid: kjuc nqa this study assessed the behavioral outcomes of coronavirus (covid- ) social distancing protocols and their influences on mental health. an online survey hosted by survey monkey was utilized to collect data from residents of three ghanaian cities of accra, kumasi and tamale. a total of surveys were analyzed, with a sensitivity analysis utilized to select covariates for the regression model. the average age of participants was about years. findings indicate that reduced physical activity time and a change in sexual activity and smoking frequency are some short-term changes in behavior resulting from social isolation during the lockdown. an increase in sedentary behavior had a negative influence on mental health. for the most part, changes in behaviors in the short-term were associated with lower mental health scores. the study implied that covid- social distancing measures should be implemented alongside public education for discouraging unhealthy changes in behaviors. coronavirus (covid- ) is a novel virus that was first detected in wuhan city, china (lewnard and lo ; lin et al. ) . over a period of < months (between december and april ), the virus grew from being a local epidemic in wuhan to a fear-inspiring global pandemic. as of september , , the virus had killed , out of , , people who tested positive for it (johns hopkins university ), making it one of the world's deadliest pandemics (lin et al. ; pung et al. ) . covid- can be considered a highly contagious virus not only because it has infected thousands of people but also because it has taken a relatively short time to spread to most regions of the world. without appropriate measures to contain it therefore, covid- could infect a third of the world in a year. as the case has been with previous pandemics, the nonavailability of a vaccine has allowed covid- to spread and grow into a global pandemic. since the testing and production of a potential vaccine for an infectious disease takes an average period of months (josefsberg and buckland ; anderson et al. ) , measures to cut the chains of infection are the only way to contain covid- in the short-term. one of such measures, which is considered the best way to contain an epidemic or pandemic in the absence of a vaccine (lin et al. ; pung et al. ) , is the enforcement of social distancing protocols in affected regions. with covid- , the adoption of this approach is a global shared goal that has brought about a complete or partial lockdown of affected countries. as demonstrated by china with its lockdown of wuhan, social distancing protocols are the ultimate weapon for fighting covid- in the short-term. this notwithstanding, their socio-economic impacts can be dire (brooks et al. ; armitage and nellums ) . economic impacts such as unemployment, the weakening of the foundation of the global economy characterized by the united states (us) and china, and a potential collapse of emerging economies, at least in the short-term, are frequently reported economic consequences of covid- (anderson et al. ; lewnard and lo ) . other consequences that are significant but seem underreported (lewnard and lo ; armitage and nellums ) are social implications such as public health decline that exacerbate the above economic losses. social distancing mechanisms, for example, could curtail individual physical activity (pa) trajectories. it is also possible that social distancing will limit access to food and public services, especially in developing countries where citizens may be unable to afford basic needs such as food if socially isolated. we argue based on the fogg behavior model (fbm) proposed by fogg ( ) that a pandemic such as covid- and its sudden lockdowns are extreme events that would cause fear and panic as people try to cope with them. per the disengagement theory of aging developed by cumming and henry ( ) , anxiety and mental health struggles may result from a sudden lockdown because social disengagement is a gradual process that would overwhelm people who try to achieve it instantly or in the short-term. we are, therefore, of the view that social isolation necessitated by a covid- -related lockdown would not only cause fear and panic in the short-term but could also lead to anxiety and consequently a decline in mental health in the general population. similarly, short-term social isolation can cause major changes in health behaviors that can increase the burden of disease and disability. this argument is corroborated by some researchers (malcolm et al. ; armitage and nellums ) who have opined that a decline in mental health is the most likely consequence of social isolation caused by an unexpected event such as the outbreak of a disease. if so, stakeholders need to understand how significant changes in behaviors and their influences on mental health are and roll out suitable programs for avoiding or at least reducing public health risks that could be predicted by a covid- lockdown. with some predicting the outbreak of a similar epidemic in future (lewnard and lo ; li and siegrist ) and others seeing the possibility of covid- spreading for a long time (li and siegrist ; pung et al. ) , stakeholders need to understand changes in behaviors that could result from a lockdown as a precursor to designing appropriate programs for discouraging unhealthy changes in behaviors. possible covid- -related changes in behaviors have been acknowledged in the literature. the most frequently acknowledged changes are reduced pa and increased sedentary behavior due to limited access to the built environment and community services during the lockdown ). on the other hand, the ability of exercise service providers to promptly move exercise classes online in response to social distancing measures have been reported jakobsson et al. ). as such, many individuals could exercise at home during the lockdown. conspiracy theories have also indicated that alcohol intake, smoking, and the use of some substances (e.g. garlic) can protect the individual against covid- . particularly in less educated populations, therefore, many individuals may take to substance use and smoking. because families including couples may spend more time together at home during the lockdown (fisher et al. ) , sexual activity and domestic violence are also likely to increase due to social distancing measures. this study aimed to examine these changes and their influences on mental health. we understand that the aforesaid changes can be affected by demographic and individual characteristics. education and income, for example, are likely to affect one's ability to utilize online exercise classes during the lockdown. for this reason, we adjusted for key covariates in testing the association between the said behavioral changes and mental health. our choice of mental health as an outcome variable draws on commentaries indicating that mental health is the aspect of health most likely to be affected in the short-term by social distancing protocols (serafini et al. ; vindegaard and eriksen benros ) . our investigation was based on this primary research question: do changes in behaviors due to covid- social distancing measures have a significant influence on mental health? this study employed the descriptive correlational approach and online surveys targeting the general population. a cross-sectional analysis technique was adopted. the exclusive use of an online survey was the only way to collect data during the lockdown. as this study was aimed at informing policy decisions for a specific region, the setting of this study was three cities (i.e. greater accra, kumasi, and tamale) affected by a covid- mandatory lockdown in ghana. the study population was individuals of the general population, preferably those aged years or more, who were socially isolated as they complied with the mandatory lockdown. participants were selected based on four inclusion criteria: ( ) currently living in any of the cities facing mandatory lockdown; ( ) having acquired at least a basic education instructed in english, the medium in which the survey was administered; ( ) being in social isolation owing to the lockdown; and ( ) willingness to participate in the study. the use of a powered sample (i.e. a sample determined based on a pre-determined statistical power and effect size) was not possible in this study for a couple of reasons. firstly, we did not find any existing study that was based on our context. secondly, we could not have used information from previous research to calculate a sample size because all existing studies applied substantially different methods. a deep look into the literature suggested that related webbased studies had utilized sample sizes ranging between n = and n = to reach credible findings (merolli et al. ; balhara and verma ; liang et al. ) . considering our research approach and the geographical scope of the study setting, we hoped to achieve a sample size between and . the survey was developed by the researchers and hosted on survey monkey, a free survey creation platform that allows data sharing and analysis between research team members. it was chosen because of the researchers' ample experience with it and the fact that it provides user-friendly data transfer and analysis tools. the survey was developed from scratch, as opposed to using a template, because no existing template was suited for our study. the survey comprised multiple-choice questions and a question introducing the mental health measure. the first question included the ethics statement and instructions for completing the survey. the next two questions (i.e. q and q ) screened for individuals who did not meet the inclusion criteria. questions - and captured demographic variables and covariates. changes in behaviors were measured with questions - as well as - . question presented the -item mental scale measure. the 'one question per page' design option that comes with the most legible text (regmi et al. ) was chosen. the survey was developed after the researchers discussed with two groups on what could be the ideal measures of mental health and changes in behaviors in the context of the study. the first group, which included four of the authors, was a whatsapp-based group made up of research fellows of a center of excellence. members, through the use of text messages and audio recordings, suggested potential measures for the study. over skype, the researchers then consulted with the second group, comprising two psychometricians and a statistician, to agree on an initial list of items for the survey. the lead researcher then developed a questionnaire of the items proposed. following this, copies of the questionnaire in sealed envelopes were sent through a private courier to individuals aged years or more who had agreed to complete it in the neighborhood of the lead researcher. this step was part of the survey piloting arrangement. over days, questionnaires were completed and returned by out of the participants through the courier. respondents commented on ambiguities and wording problems associated with the questionnaire. through a voice call, the lead researcher contacted the participants to confirm and better understand the issues reported, enabling the researchers to further improve the wording of the items. a major change made to the instrument was replacing the word 'self-isolation' with 'social isolation' in most of the measures. an online survey of the final items (including an ethics statement) was then developed and piloted online with different participants (whatsapp = ; facebook = ; twitter = ). with no issues identified in the second pilot study, we sent the survey back to the two psychometricians consulted earlier for approval. this study focused on possible short-term changes in behaviors resulting from covid- -related social isolation or fears. changes in smoking frequency, alcohol intake, and substance dependence were incorporated into the study owing to fake news about the possibility of smoking and the dependence on some substances (e.g. garlic, alcohol, marijuana) protecting against covid- . the other changes in behaviors were considered because they could be encouraged by social isolation. table shows a summary of all changes in behaviors and their operationalization. as table indicates, categorical variables were dummy-coded and one of their levels (categories) set as the reference. the table also shows underlying health conditions and demographic variables that, per existing studies (sederer ; lund et al. ) , can confound the primary relationships of interest. mental health was measured with a -item standard scale (with descriptive anchors strongly disagree- ; disagree- ; the individual's gross monthly income continuous --somewhat agree- ; agree- ; and strongly agree- ) from lukat et al. ( ) . this tool is a unidimensional scale that produced satisfactory psychometric properties (including a cronbach's α coefficient = . ) on a sample representing the general population. it was preferred to other mental health measures because it has been properly validated for the general population and is the most holistic mental health measure (lukat et al. ). in the current study, it produced a satisfactory cronbach's α coefficient of . . scores on the mental health measure were generated in harmony with the lukat and colleagues; items were 'parceled' by adding them up. appendix table shows items of the mental health measure used. this study received ethical clearance from an institutional ethics review committee (# -ace) after the research protocol and ethical statement were reviewed by the committee. in agreement with best practices, we ensured that the first question of the survey presented the ethical statement (merolli et al. ; balhara and verma ) , which means that only individuals who agreed to participate voluntarily (by ticking 'yes') completed the survey. the ethical statement indicated the purpose and importance of the study as well as the risk-free nature of our data collection process. the inclusion criteria and instructions for completing the survey were also presented as aspects of the ethical statement. we created different versions of the survey that could easily be completed on all social media platforms including whatsapp. we published the survey a week after the lockdown by sending a link of it to all our contacts using whatsapp and asking them to complete the questionnaire and share it with their contacts. thus, snowball selection was applied to distribute the survey. subsequently, the researchers, through their personal accounts, published the link on facebook, twitter, linkedin and other social media platforms. the shared link took the participant to a pop-up questionnaire that could be completed even with a relatively weak internet network. participants did not have to download the survey before completing it. the survey was distributed and completed over about weeks (april - , ) and was closed on april , . its average completion time was about min. we programed the survey at survey monkey to prevent multiple responses from the same participant. for further research purposes, we designed the survey to allow individuals outside the study setting to respond. we did not provide incentives for participation. data in a microsoft (ms) excel format were downloaded from survey monkey. coding was done in ms excel and the resulting data transported to spss version (ibm inc., ny, usa), which was used for data analysis. descriptive statistics (frequency and per cent) were used to summarize the data after five questionnaires with missing items were discarded in line with the recommendation of garson ( ) . the shapiro-wilk's test was performed to screen for outliers and confirm normality of data of mental health (garson ) . this test on the data confirmed normality (p = . ) and the absence of outliers. pearson's correlation test was then used to assess bivariate correlations between the variables. a multiple linear regression model was fitted to assess the influence of the changes in behaviors on mental health, with potential confounding variables adjusted for. before fitting the regression model, a sensitivity analysis was conducted to screen for relevant potential confounding variables in harmony with the procedure adopted elsewhere (rothman and greenland ; rezai et al. ) . in this analysis, univariate regression models were used to estimate crude coefficients (i.e. standardized and unstandardized coefficients and their % confidence intervals) indicating the influence of the covariates and changes in behaviors on mental health. covariates with p > . were removed and those with p ≤ . were kept for the second level of the sensitivity analysis. at this stage, only chronic disease status (cds) was removed. at the second level, multiple linear regression models were fitted to estimate coefficients (including their % confidence intervals) representing the influences of changes in behavior and each of the remaining covariates on mental health. any covariate that led to a % change (decrease or increase) in the coefficients of the behaviors from the first level was kept and incorporated into the final regression model (see table ) as a covariate. at this stage, age and income were removed. we achieved a survey completion rate of %, which means all participants (n = ) completed the survey. after applying the inclusion criteria, questionnaires were dropped. of the remaining questionnaires analyzed, % (n = ) were completed by residents of accra, % (n = ) by residents of kumasi; and % (n = ) by residents of tamale. as table indicates, about % (n = ) of participants were female and % (n = ) were male. about % of participants (n = ) had tertiary education, which means that most of the sample had a high education. the age of participants ranged between and years. table shows some dramatic changes in behaviors. that is, % of participants lost moderate physical activity time, with over similarly, more than % added at least h to their sedentary behavior time. about % (n = ) of participants were exercising during the lockdown, whereas there was no change in the frequency of smoking for % (n = ) of participants who were smokers. the frequency of alcohol intake increased for % (n = ) and did not change for % (n = ) of participants. the frequency of eating decreased for % (n = ) and increased for % (n = ) of participants. about % (n = ) of participants agreed they used substances to protect themselves against covid- and faced a higher risk of domestic violence. sexual activity decreased for % (n = ) and increased for % (n = ) of participants. appendix table shows a distribution of average mental health scores across categorical predictors. table shows some significant correlations at p < . and p < . . for example, mpatl and mental health are negatively correlated (r = − . ; p < . ; two-tailed). this result connotes that mental health decreases as moderate physical activity time lost increases. table shows regression coefficients resulting from this and other correlation coefficients in table . it can be seen that moderate pa time lost makes a significant influence on mental health (β = − . ; t = − . , p < . ), suggesting that mental health decreased with an increase in moderate pa time lost. sedentary behavior time added also made a negative influence on mental health (β = − . ; t = − . , p = . ). the influence of 'sf-unchanged' is about times lower compared with that of 'sf-non-smokers' (b = − . ; t = − . , p = . ), which indicates that the mental health of individuals who did not have a change in their smoking frequency was lower compared with non-smokers. the influence of 'ai-not applicable' on mental health is about times lower compared with that of 'ai-increased' (b = − . ; t = − . , p = . ), implying that individuals who did not drink alcohol at all reported lower mental health scores compared with those whose frequency of alcohol intake decreased. the influence of 'ai-unchanged' on mental health is about . times higher compared with that of 'ai-decreased' (b = . ; t = . , p = . ), indicating that individuals whose frequency of alcohol intake remained the same reported larger mental health scores compared with those who had a decrease in their frequency of alcohol intake. an increase in eating frequency (i.e. ef-increase) and a decrease in eating frequency (i.e. ef-decrease) were both associated with lower influences on mental health compared with 'ef-no change'. that is, compared with those whose eating frequency remained the same, individuals whose eating frequency increased or decreased reported lower mental health scores. those who used substances to protect themselves against covid- had better mental health compared with those who did not (b = . ; t = . , p < . ). finally, those with increased sexual activity (i.e. sa-increase) had better mental health compared with those whose sexual activity level did not change (β = . ; t = . , p = . ). the independence-of-errors and multicollinearity assumptions were met based on tolerance ≥ . (for each predictor) and durbin-watson = . (for the regression model) in table (garson ). a major change in behavior resulting from covid- -related social isolation is a reduction in physical activity and an increase in sedentary behavior time. ellingson et al. ( ) conducted in the us also backs our result with its evidence that a loss in moderate pa time and an increase in sedentariness is negatively associated with mental health in young adults. more so, several studies (walsh ; allen et al. ; shim et al. ; lund et al. ) reported a negative influence of reduced pa or increased sedentary behavior on mental health in the general population. unlike previous pieces of evidence however, our result is the first linked to social isolation driven by a pandemic. a noteworthy connotation of our result is that social distancing measures should be rolled out with pa promotion programs to encourage indoor pa during social isolation. it may thus be necessary for governments to intensify pa counseling via the media before and during a lockdown. as done in parts of the uk (mytton et al. ; anderson et al. ), gyms and parks should be considered essential service providers and allowed to operate during a lockdown. however, a strict observance of social distancing protocols at these pa centers is imperative. despite the strong force with which conspiracy theorists used the social media to promote smoking as a behavior that protects against covid- (li and siegrist ; anderson et al. ) , this study did not find any change in smoking among socially isolated participants. based on , we argue that this result may be due to the fact that over % of the sample were highly educated individuals who may not yield to unfounded claims. besides, smokers whose frequency of smoking did not change reported lower mental health scores than their colleagues who never smoked. this finding endorses previous studies that have found a negative relationship between smoking and mental health (lawrence et al. ; walsh ; allen et al. ; shim et al. ; lund et al. ) . coupled with other distressing conditions caused by social distancing during the spread of covid- , our result may be an indicator of an intensified consequence of smoking. in any case, campaigns discouraging smoking and related behaviors during a lockdown ought to be intensified. since the primary weapon for fighting many infectious diseases such as covid- is the individual's immunity, behaviors such as smoking that have the tendency of weakening or disabling the immune system (lawrence et al. ; lund et al. ) must be eschewed at the individual level. for this reason, there is no alternative to conscientizing smokers regarding the health risks of smoking, particularly for those socially isolated. a key change in behavior associated with covid- -related social isolation is a decrease and increase in the frequency of alcohol intake. interestingly, those who did not drink alcohol at all reported smaller mental health scores compared to those who maintained their frequency of alcohol intake. this outcome tends to support previous empirical studies (german and walzem ; kaplan et al. ; chiva-blanch and badimon ) confirming a positive table the association between mental health, changes in health behaviors, and covariates (n = ) b unstandardized coefficient, β standardized coefficient, ci confidence interval, s.e. standard error (of b), sbta sedentary behavior time added, mpatl moderate physical activity time lost, vpatl vigorous physical activity time lost, sf smoking frequency, ai alcohol intake, ef eating frequency, sa sexual activity, dvi domestic violence increase a dummy variable for smoking frequency with 'sf-non-smoker' as reference b dummy variable for alcohol intake with 'ai-decreased' as reference c dummy variable for eating frequency with 'ef-no change' as reference d dummy variable for sexual activity with 'sa-no change' as reference **p < . ; *p < . (kaplan et al. ; chiva-blanch and badimon ) have warned that excessive consumption of alcohol increases the risk of disease. this being so, an increase in the frequency of alcohol intake can cause a major public health concern, especially for those forced into social isolation owing to the spread of an infectious disease such as covid- . a change in the frequency of eating as a result of social isolation is a key finding of this study. while a fall in eating frequency may be due to poor access to supermarkets and supplies, an increase is possible for the working class or managerial elites with abundant food supplies. as social isolation during the lockdown compelled individuals to spend more time at home, an increase in the frequency of eating among those with enough savings is likely. this can be said of most of our participants who were highly educated and had a regular income. further to the above, an increase and decrease in the frequency of eating were associated with lower mental health scores, logically because an increase translated into abuse of food while a decrease resulted in malnutrition in the short-term. this thinking squares with studies (prentice ; fuhrman ) that have revealed that food can only confer its nutritional and health benefits when consumed in moderation. moreover, short-term side effects of over-and/or under-eating include mental health struggles that can compel individuals to poorly rate their mental health (prentice ; fuhrman ) . with these possibilities in view, programs for conscientizing residents facing a lockdown would have to be cognizant of potential changes in dietary behaviors. a segment of our sample used substances (e.g. garlic, ginger) to protect themselves against covid- during social isolation, which points to the likelihood that people were influenced by fake news regarding the protective properties of eating garlic, ginger, and other substances against covid- . more interestingly, those who used these substances reported higher mental health scores, an outcome that tends to add weight to claims that garlic, ginger, and similar substances have anti-inflammatory properties and therefore enhance the immune system and confer other health benefits (arreola et al. ; percival ) . we would want to reason that the foregoing result was possibly driven by participants' psychological reaction to using substances to protect themselves against covid- . that is, dependence on substances may have boosted the confidence of participants in their health and consequently made them to overrate their mental health. whether substance use was well-fated or a guise, it is understandable that people are likely to use unprescribed substances during the lockdown to protect themselves against covid- . regardless of its impact on mental health in this study, substance use could mar individual and public health, thereby causing disabilities that may cost governments a fortune to rehabilitate. over the years, empirical research has produced mixed findings regarding the influence of sex on mental health (bennett ; galinsky and waite ) , but researchers, from a psychology perspective, have reasoned based on different scenarios that mental health could improve with sexual activity (ganong and larson ) . congruent with this stance is our result indicating an increase in mental health in those whose sexual activity increased. a common explanation to a positive influence of sexual activity on mental health is that sexual intercourse and romance increase individuals' happiness and satisfaction with life if they satisfy the individuals emotional needs (bennett ; galinsky and waite ) . we opine based on this argument that sexual activity would make a positive short-term influence on mental health during covid- -related social isolation. we would want to premise this stance around the idea that sexual activity in the early days of the lockdown may have provided total emotional satisfaction possibly because most participants, who make up an elite working class, did not have enough time for sex before the lockdown. as such, the participants had unsatisfied sexual needs before they went into social isolation. psychologists explain that an increase in sexual activity to meet one's unsatisfied sexual needs always produces mental health benefits (galinsky and waite ) . drawing on the foregoing assertion, we admit that changes in behaviors and their influences on mental health may differ in the long run when people may successfully adapt to the lockdown or use up economic resources saved. moreover, the dynamics may differ from what was explained based on the disengagement theory and fbm in the shortterm, leading to a more or less compelling changes in behaviors. we, therefore, concede that focusing on short-term changes in this study is a major shortcoming that future researchers should address. this said, further studies may adopt randomized longitudinal designs to assess the impact of time on the changes considered in this study as well as their effects on mental health. we are also worried that our sample was not powered and may, as a result, not be representative of the general population. while we believe findings of this study may apply to some settings owing to the normal distribution of our data (garson ; yap and sim ) , it is important for future studies to use representative samples to enhance the generalizability of our results. the replication of this study in new contexts may suffice in situations where the use of a powered or representative sample is not possible. some segments of the population (e.g. older people) who did not use the internet were not included in the sample. with english serving as the sole medium of questionnaire administration, residents with poor english skills may have been underrepresented. despite these limitations, this study is novel for being the first to assess changes in behaviors that may result from self-isolation during the spread of an epidemic. it does not only provide a foundation for future research but also offers insights into what stakeholders could do to ensure that behavior changes do not compound public health issues accompanied by the spread of an epidemic or a related extreme event. at least, this study makes us to contemplate the need for covid- social distancing measures to be rolled out alongside public education programs for discouraging unhealthy changes in behaviors. the study confirms short-term changes in behaviors attributable to covid- -related social isolation, with key examples being a reduction in individuals' physical activity time and an increase in sedentary behavior time. sexual activity and eating frequency have changed in the short-term owing to covid- -related social isolation. an increase in sedentary behavior time has made the most compelling negative influence on mental health, which suggests that the biggest decline in mental health in our sample was due to increased 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normality tests acknowledgements we thank members of the 'share research-ace' whatsapp team including dr samuel awuni azinga and mr wisdom mensah avor for their technical advice and guidance. we acknowledge hon. kojo yankah for proofreading this manuscript. author contributions na conceived the research project and wrote the manuscript. ffo coordinated data collection and survey administration. em analysed the data. swm contributed to survey design, validation, and data collection. hkm and fq contributed to the design of the survey and formatted the manuscript. all authors read and approved the draft manuscript.funding the researchers did not receive funding for this study. conflict of interest the authors declare that they have no conflict of interest.ethical approval this study was approved by the institutional ethics review board (with code # -ace). the board ensured that participation in the study was voluntary and the study was not harmful to participants.informed consent every participant provided informed consent before completing the survey. see table . key: cord- -qxkopvot authors: schreibauer, elena christina; hippler, melina; burgess, stephanie; rieger, monika a.; rind, esther title: work-related psychosocial stress in small and medium-sized enterprises: an integrative review date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: qxkopvot background: work-related psychosocial stress can cause mental and physical illnesses resulting in high costs for the individual, the economy and society. small and medium-sized enterprises (smes) employ the majority of the world’s workforce and often have fewer financial and human resources compared to larger businesses. the aim of this review is to summarize current knowledge on work-related stress in smes according to well-established guidelines categorizing psychosocial factors at work. methods: a systematic database search was carried out in pubmed, psycinfo, psyndex and business source premiere from march to june , updated in january . data of included studies were analyzed and mapped into five themes: “work content and task”, “organization of work”, “social relations”, “working environment” and “new forms of work”. results: after full-text screening, out of studies were included for data extraction. studies were very heterogeneous and of varying quality, mostly applying a cross-sectional study design. psychosocial factors in smes have been researched with a focus on the work patterns “work organization” and “work content and task”. conclusions: this review underlines the need for more and better quality research of psychosocial factors in smes, particularly in relation to ongoing and new challenges in the workplace, including stressors related to the process of digitalization or the development of safe working conditions during the emerge of new infectious diseases. according to the international labour organization (ilo), . million workers die from work-related diseases each year and there are about million non-fatal work-related injuries annually [ ] . this results in human and economic costs of about % of the annual global gross domestic product [ ] . additionally, work-related psychosocial risks, comprising issues such as work-related stress, have been identified as significant risks in the field of occupational health and safety over the last two decades [ , ] . however, as of yet only a few countries have drafted specific regulations on psychosocial risks (e.g., the belgian royal decree on the prevention of psychosocial risks at work or the colombian resolution on risk assessment and management of psychosocial hazards from ) or have implemented existing policies in their national occupational safety and health legislation [ , ] . furthermore, there is little evidence whether and how these recommendations and policies can be implemented in a working environment with limited human and financial in order to support enterprises with the development of instruments and interventions to reduce psychosocial risks, knowledge on relevant work-related psychosocial factors is essential. between - , the german federal institute for occupational safety and health (baua) conducted several literature reviews to describe the scientific evidence regarding mental health in the working world [ ] . based on well-established theoretical models including the job-demand-control-model [ ] , the effort-reward-imbalance-model (eri) [ ] or the organizational justice (oj) model [ ] , a framework was developed to categorize the results into four subject areas: "working task", "leadership and organization", "working time" and "technical factors". the reviews did, however, not specifically focus on the situation of employers and employees working in smes. furthermore, the joint german occupational safety and health strategy (gda) published recommendations for implementing psychosocial risk assessments listing five work patterns (i.e., work characteristics) that have been identified as primary stress factors in the workplace [ ] : • work content and task (e.g., job autonomy, completeness of tasks, emotional demands); • organization of work (e.g., working time and processes); • social relations (e.g., aspects of hierarchy, leadership and managerial abilities); • working environment (e.g., physical factors, working equipment); • new forms of work (e.g., spatial and temporal mobility). to organize the results of this review, we used this classification because it comprises all of the psychosocial factors published by the baua [ ] and integrates factors published by other well-established international frameworks (eu-osha (the european agency for safety and health at work) [ ] , who (world health organization) [ ] and ilo [ ] ). furthermore, the gda-classification includes a systematic table and detailed examples of work-related psychosocial demands which provided a useful framework for a clear assignment of the studies identified in this review. to the best of our knowledge, this review is the first to summarize and categorize the current evidence on work-related psychosocial demands with a specific focus on small and medium sized enterprises to identify gaps in current knowledge and provide a systematic overview of which psychosocial factors, outcomes and economic sectors have been considered to date. the subsequent research questions guided our review: ( ) what is the current state of knowledge on psychosocial demands in smes? ( ) which outcomes and economic sectors have been examined? we conducted an integrative review according to the five-stage method described by whittemore et al. [ ] . to select relevant studies, we used the peo criteria (population, exposure, outcome) which are applied frequently in evidence-based health research [ , ] . for our study, we defined the criteria as follows: p = workforce in smes (with smes defined according to the eu definition: number of employees < [ ] ) and e = psychosocial demands as defined by the gda [ ] . we did not predefine any outcomes for the literature search because we did not want to limit our review to certain health or health-related outcomes. the literature search was carried out between march and june and updated in january with individually adapted search strings in medical (pubmed), psychological (psycinfo, psyndex) and economic (business source premiere) databases. additionally, we performed a hand search of the reference lists of the studies included. the search terms followed this general scheme: terms related to "workforce in smes" and terms related to "psychosocial demands". we also considered relevant medical subject headings (mesh)-terms and search terms previously published [ ] . terms including "family business(es)" were excluded because this resulted in a considerable number of articles not relevant in our context. for example, many articles dealt with the financing of micro-enterprises or the family income situation in developing countries. the complete search strategy for pubmed and the applied search string is presented in supplementary table s . we included all types of peer-reviewed quantitative and qualitative studies as well as literature reviews relevant to the sme setting considering at least one of the psychosocial demands listed by the gda [ ] . articles that did not report employment figures, but whose surveyed enterprises were designated as smes, were included if their sme definition complied with the european definition [ ] . if multiple publications were based on the same dataset, all papers meeting the inclusion criteria were selected. we limited our search to articles published in german or english from january onwards, the beginning of the fourth industrial revolution promoting digital processes in the working environment [ , ] introducing new stressors to the workforce such as digitized performance monitoring or information overload [ , ] . furthermore, we excluded study protocols as well as publications which tested and/or validated questionnaires on psychological demands or work-related stress. we also excluded reviews because we considered the original research and did not consider any kind of "grey literature". after the removal of duplicates, all studies were transferred to rayyan [ ] , a free web application for systematic review screening. two raters (e.c.s. and s.b.) screened titles and abstracts independently, according to the predefined inclusion and exclusion criteria. articles that could not be judged by title and abstract were included in the full text screening, also independently executed by two raters (e.c.s. and m.h.). lack of agreement was solved in consensus discussions with a third reviewer (e.r.). a tabular scheme for data extraction (author, year, country, year of data collection, topic, study design, data collection methods, type of enterprise, sample size, industrial classification of the business, investigated psychosocial demands, outcomes, and data collection instruments) was compiled and used for data extraction. we used the agency for healthcare research and quality ahrq study design algorithms [ ] to classify the study design if it was not reported. the allocation of the studies to economic sectors was carried out according to the international standard industrial classification of all economic activities (isic) [ ] . we amended the classification of the baua-project [ ] to categorize the outcome variables of the studies into these subcategories: general (work-related) stress outcomes, health, well-being, factors affecting cardiovascular health, mental health, musculoskeletal system, social relations, and business-related outcomes. different tools were used for critical appraisal: the special unit for review evidence (sure) checklist for cross-sectional studies [ ] the sure-checklist of randomized controlled trials and other experimental studies [ ] , the sure-checklist for qualitative studies [ ] , and the joanna briggs insitute (jbi)-critical appraisal tool [ ] for text and opinion articles to assess the quality of narrative reviews. we identified studies through electronic data base searching (see prisma-flowchart [ ] figure ). after the removal of duplicates, studies remained for title and abstract screening, including eleven articles detected by hand search. for the full-text-screening, articles were eligible, of which were included in the full text analysis (figure ). the first article suitable for this review was published in . since then, the annual number of publications was relatively low (< /year) with a peak in , when nine articles were published. due to our main database search in the first half of (hand search update march ), it can be assumed that studies published in were not completely indexed at that time. the first half of (hand search update march ), it can be assumed that studies published in were not completely indexed at that time. the samples of the studies were very heterogeneous. the number of participants varied between seven and , . five studies included only sme-managers and enterprise owners [ ] [ ] [ ] [ ] [ ] . some studies used data from nationwide surveys that provided a large sample size and included a range of economic sectors and branches [ , , [ ] [ ] [ ] [ ] [ ] [ ] . other studies included only participants of a single enterprise [ ] [ ] [ ] [ ] . a complete summary of the study characteristics can be found in supplementary table s . most of the studies included were carried out in europe (n = ) and in asian countries (n = ). other studies were conducted in australia [ , ] , the united states [ ] and new zealand [ ] . four studies from japan [ , [ ] [ ] [ ] seemed to use data from the same survey but examined different outcomes. no studies from africa or south america met our inclusion criteria, and four studies were transnational [ , [ ] [ ] [ ] . the majority of studies were cross-sectional (n = ), analyzing a variety of psychosocial factors in the sme-setting, mainly using data from nationwide surveys or specifically designed questionnaires for particular companies or settings. we also identified qualitative studies (n = ), narrative reviews (n = ), and intervention studies (n = ). one qualitative study [ ] looked at the samples of the studies were very heterogeneous. the number of participants varied between seven and , . five studies included only sme-managers and enterprise owners [ ] [ ] [ ] [ ] [ ] . some studies used data from nationwide surveys that provided a large sample size and included a range of economic sectors and branches [ , , [ ] [ ] [ ] [ ] [ ] [ ] . other studies included only participants of a single enterprise [ ] [ ] [ ] [ ] . a complete summary of the study characteristics can be found in supplementary table s . most of the studies included were carried out in europe (n = ) and in asian countries (n = ). other studies were conducted in australia [ , ] , the united states [ ] and new zealand [ ] . four studies from japan [ , [ ] [ ] [ ] seemed to use data from the same survey but examined different outcomes. no studies from africa or south america met our inclusion criteria, and four studies were transnational [ , [ ] [ ] [ ] . the majority of studies were cross-sectional (n = ), analyzing a variety of psychosocial factors in the sme-setting, mainly using data from nationwide surveys or specifically designed questionnaires for particular companies or settings. we also identified qualitative studies (n = ), narrative reviews (n = ), and intervention studies (n = ). one qualitative study [ ] looked at psychosocial resources instead of focusing on psychosocial risks like most other studies. however, as a single-case study, there are issues with the transferability of the results. the other qualitative study [ ] aimed to identify challenges faced by novice community pharmacists at transition to independent practitioners. the three narrative reviews [ ] [ ] [ ] focused on changing work characteristics in smes during the first years of the th century. cooper [ ] analyzed the changing world of work and its impact on employees and their families in that period. he focused on new forms of work, affecting most of all employees in smes, as well as self-employed and workers outsourced in virtual organizations. allan et al. [ ] investigated challenges of online learning in smes. yuhshy [ ] discussed work-and family-related stress as significant problems of smes. we identified only three intervention studies [ , , ] : casteel et al. [ ] evaluated an intervention to reduce violent crimes in smes. magnavita [ ] reported an intervention to reduce psychosocial risks at the workplace in smes. he described a cost-effective participatory model and emphasized the usefulness of regular health examinations as they can be used to identify problems in the workplace climate and work organization. in a controlled intervention study, torp [ ] reported results of a -year training program for managers of small and medium-sized enterprises. he examined the program's impact on the companies' health and safety management systems and on the mental and physical health of employees. applying the sure-criteria [ ] , the internal validity of these studies was rated as medium quality, because of some methodological limitations and limited representativeness. furthermore, we identified four studies investigating the differences of job stress in smes compared to large firms [ , , , ] . whereas tsai et al. [ ] found higher levels of job stress and "higher favorable attitudes toward managers" in smes, lai et al. [ ] obtained no firm size effect on overall job stress after adjusting for covariates including individual and organizational characteristics (information on job tenure, contractual status, gender, age, marital status, number of children, caring responsibility, long-term illness, academic qualification, weekly pay, work condition changes, organizational support) in an european (u.k.) sample. yeh et al. [ ] reported higher job demands, higher job insecurity, lower job autonomy and lower career prospect in smes, compared to those of large private enterprises and the public sector. encrenaz et al. [ ] investigated the influence of the size of enterprises on mental health and the mediating role of perceived working conditions in this relationship by measuring the outcome "anxious/depressive episodes" in employees. between micro-enterprises compared to the others, there were differences in perceived working conditions: taking working conditions into account, the risk of "depressive/anxious episodes" was larger in micro-enterprises. as summarized in table , most studies investigated several work characteristics with a focus on factors related to 'work content and task' (n = ) and 'organization of work' (n = ), followed by factors related to 'social relations' (n = ), 'new forms of work' (n = ) and the 'working environment' (n = ). only one study considered all five work characteristics to measure work quality in smes [ ] . a relatively high number of studies assessing the work characteristics 'work content and task' included the factors 'freedom of action' (n = ), 'responsibility' (n = ) and 'emotional demands' (n = ). multiple studies also investigated factors related to 'organization of work', mostly looking at 'work time' (n = ), 'work process' (n = ), and 'communication/cooperation' (n = ). however, the correlations of these factors with the outcomes were not always reported. many studies also investigated the work characteristics 'social relations'. for example, berthelsen et al. [ ] measured perceived social support in the workplace among danish dentists, and agervold et al. [ ] measured social contact, social climate and management style in a danish manufacturing company. intragroup conflict and social support were assessed by three japanese studies [ , , ] . the work characteristics 'social relations' in general were measured by four studies [ , , , ] and one study referred to siegrist's effort-reward-imbalance model (eri) [ ] , in which the eri questionnaire was used to asses occupational stress with items on esteem and job promotion. the work characteristics 'working environment' and 'new forms of work' have received less attention. only three studies measured physiochemical factors: 'lighting' was measured by two studies [ , ] , 'climate' was measured only by isahak et al. [ ] . rhee et al. [ ] assessed the variables "hazardous work condition" and "handling of hazardous materials". three studies investigated physical factors: "physical occupational activity" [ ] , "poor physical working conditions" [ ] and "heavy physical work, repetitive activities, forced postures and risks of falls" [ ] . the factor 'workplace and information structure' was only studied by díaz-chao et al. [ ] ("workspace"). the factor 'work equipment' was taken into account by sonnentag et al. [ ] looking at "situational constraints associated with malfunctioning, missing, incomplete, or outdated equipment, tools, or information". myers et al. [ ] investigated "staff and technical problems", including 'equipment breakdown and defective materials'. the characteristics 'new forms of work' was taken into account by eight studies. job insecurity was measured by five studies [ , , , , ] . flexible work hours and work-life-balance was taken into account by three studies [ , , ]. cooper's [ ] theoretical exploration focused on several aspects of new forms of work, including free-lancers, flexible working hours, and work-family-conflicts related to new forms of work. there was only one study [ ] focusing on accessibility and expected availability of workers due to new communication methods. another study investigated the work-home interference and well-being of self-employed entrepreneurs [ ] . mental health risks and resources were the most commonly studied outcomes. as shown in table , many studies examined mental health outcomes (n = ), with general (work-related) stress outcomes being the second most studied (n = ), followed by outcomes representing business-related outcomes. coping self-efficacy [ , ] seven-item coping self-efficacy scale (cse- ) depressive symptoms [ ] japanese version of the center for epidemiologic studies depressive symptoms scale (ces-d) depressive episodes [ ] hospital anxiety and depression scale (hads-d) training needs [ ] unspecified questionnaire (probably self-developed) importance of work [ ] mow's question on the centrality of work general stress and mental health outcomes were assessed more often as risks, business outcomes were assessed almost equally as risks and resources and social relations were examined more often as resources. the only non-self-reported outcomes were blood pressure and the observed rate of violent crimes; all other outcomes were assessed as self-reported outcomes, mostly via questionnaires. several studies (n = ) examined manufacturing enterprises (please see supplementary table s ). each of the other economic sectors was considered by less than six studies. eight studies [ , , , , , , , ] included several sectors; for example; lai et al. [ ] used data of a nationwide survey with participants of all industrial sectors, godin et al. [ ] and cocker et al. [ ] examined entrepreneurs of several sectors. seven studies [ , [ ] [ ] [ ] , , ] did not provide information on particular economic sectors. in this review, we evaluated the current evidence on work-related psychological stress in smes, also summarizing the type of outcomes investigated as well as the economic sectors considered. the majority of the studies were cross-sectional (n = ). we also identified qualitative studies (n = ), narrative reviews (n = ), and intervention studies (n = ). as most studies applied a cross-sectional design investigating relationships between various outcomes and psychosocial factors in the workplace, the number of studies investigating causal relationships was relatively low. only one study conducted an intervention specifically developed for the sme setting [ ] indicating a lack of studies applying a high quality research design (e.g., randomized controlled trials) with a focus on psychosocial stress in the smes. all studies were published from to considering very heterogeneous populations of smes. we did not find suitable studies from to . as the definition of smes was inconsistent at the beginning of the century, articles from this period may not have met the inclusion criteria of the european definition of smes. since smaller enterprises have become a focus for researchers and policy makers in recent years, this may have resulted in an increased number of publications from onwards. only one study [ ] investigated all five dimensions of work-related psychosocial demands as defined in the gda recommendations [ ] . although these recommendations are based on the european council directive [ ] and have great similarities with other international classifications (e.g., [ ] , p. ), we appreciate that the gda recommendations have been developed with a focus on the german context and may not be transferable entirely to other settings. nevertheless, since the job-demand-control model [ , ] and the extended job-demand-control-support-(jdcs-) model [ ] have been used for decades, work characteristics based on these models, have found their way into many study-designs and work-stress questionnaires. this resulted in a frequent examination of the work pattern 'work content and task' although some of the subcategories were hardly considered ('variability) or not mentioned at all ('completeness of task'). the work patterns 'organization of work' and 'social relations' have also been considered frequently. although the psychosocial health effects of the working environment have been studied as a cause for work-related illness for decades e.g., [ ] , this work characteristics including 'physicochemical factors' or 'physical factors' have received little attention from the psychosocial perspective in the studies we identified in this review. in terms of advancing digitalization, topics such as 'workplace and information structure' are important fields of research as they involve the risk of information and stimulus satiation [ ] . their psychosocial impact on employees in small and medium-sized enterprises appears to have been poorly researched to date. this may be related to the slow pace of digitization in smes requiring financial and human resources, frequently exceeding the means of small enterprises [ ] . the european agency for safety and health at work (eu-osha) recognized job insecurity, precarious work, intensification of work and higher requirements for flexibility and mobility from workers as emerging risk for health and safety [ ] ; nevertheless, 'new forms of work' also have received little attention in the setting of smes [ ] . we also classified the outcomes considered according as defined by the baua-project [ ] including these subcategories: general (work-related) stress outcomes, health, well-being, factors affecting cardiovascular health, mental health, musculoskeletal system, social relations, and business-related outcomes. most outcomes were related to the fields of general stress, mental health and business. there appears to be a gap in the investigation of outcomes on physical health, particularly those representing cardiovascular health, even though the link between work-related stress and physical illness is well established [ , ] . promoting and maintaining the health of employees is the fundamental purpose of occupational medicine. prevention is therefore particularly important. work-related resources were, however, less frequently studied than risks, and most outcomes considering resource were related to the fields of 'social relations' and 'business-related outcomes'. factors considering the prevention of work-related stress and the promotion of a healthy working environment should therefore be considered more frequently in sme-research. finally, we categorized the studies identified to the international standard industrial classification of all economic activities (isic) [ ] . with few exceptions, the number of studies allocated to economic sectors corresponded to the frequency with which smes in europe and asian countries are represented in these sectors [ , ] . in the eu- , for example, employment was highest in smes active in the sectors 'construction' ( , %) and 'wholesale and retail trade; repair of motor vehicles and motorcycles' ( , %) between and [ ] . although we identified a number of studies (n = ) investigating psychosocial demands in these sectors, the highest number of studies looked at smes active in 'manufacturing' (n = ) where the percentage of employment was considerably lower ( . %). this may be related to differences in lobbying activities which have been shown to be relatively high in the manufacturing sector compared to other sectors including 'wholesale trade' [ ] . the other economic sectors were partly more typical for large enterprises (e.g., electricity suppliers, oil companies, insurance companies) or public and civil-service institutions (hospitals, schools, public offices) and, as expected, fewer studies were identified here. within the sector 'human health and social work activities' four studies were identified looking at psychosocial factors in the setting of general dentists' practices, pharmacies and a welfare and assistance agency for professionals. although the setting of myers et al. [ ] and magola [ ] was not clearly in the sme area (myers et al. examined dental practices that were also partly funded by the british national health service (nhs), magola included pharmacists who also worked for larger chains), the studies were included in this review because they represented the sector of healthcare and the organizations under review (dental practices and pharmacies) which ultimately had the structure of an sme. we also expected family or medical practices to be characterized as small businesses, but no corresponding study was identified also indicating that these "enterprises" were unlikely to be categorized as a typical sme [ ] . this review also has some limitations. our broad research objective was very useful to give an overview of the current state of research and to detect gaps in knowledge. however, it was not suitable for a "classic" systematic review design and resulted in a heterogeneous sample of included studies and a high number of irrelevant hits, particularly in the database "business source premiere" which identified numerous entries on "financial stress" not related to our research objective. the bias risk has been minimized by a strict application of review methods like systematic literature search and reviewing by independent reviewers. the broad question and the application of the peo scheme could also be the reason for finding only three intervention studies. it may be appropriate to search particularly for intervention studies in smes; however, a recent review from examined health interventions in smes and only one of the included studies met our inclusion criteria [ ] . the reasons for this may be related to applying different sme definitions, the inclusion of public institutions or the exclusion of work-related psychological factors as most of the interventions considered in the review [ ] dealt with physical fitness or work-safety-interventions. to provide a more manageable and specific set of results, we have refrained from using 'family business terms' in our search string. apart from using a european definition of smes, this could also be a reason why we did not identify studies from south america and africa. to study psychosocial factors in the family business setting, a new search with a more specific search term would be required. the same may be true for micro-enterprises which may not be covered by our search string in all databases. furthermore, the consideration of "grey literature" (e.g., governmental reports) may provide further evidence in this context. finally, we aimed to categorize all studies identified in this review according to well-established frameworks [ , , , ] . nevertheless, the process of systematization was partly subjective since psychosocial factors are mostly interdependent or interrelated; hence, we could have also chosen different categorizations for some of the studies identified. psychosocial risks differ between large companies and smes [ , , ] . since smes represent the majority of all companies worldwide, it is important to conduct research specifically focused on smaller enterprises, also including micro-enterprises. as early as , cooper et al. [ ] called for further studies to investigate the long-term effectiveness of stress intervention strategies. with the findings of this review we can renew this demand for the sme setting. in order to offer smes effective interventions for the primary prevention of psychosocial risks, the long-term effects of the interventions should be examined applying high-quality study designs. for the development of interventions, it would be desirable to measure all dimensions in which psychosocial risks may occur and resources can be established and consolidated, rather than limiting the assessment of psychosocial stress to single factors. hereby, the dimensions of psychosocial risks defined by the gda [ ] proofed to be a good framework for the classification of the studies identified. furthermore, we would like to point out that about one third of the outcomes identified were measured using self-developed items, scales or questionnaire, or by using adapted preexisting questionnaires. on the one hand this complicates the comparison of results with prior research and may impact the validity and reliability of previously established measures. on the other hand, it may be necessary to develop new instruments suitable for a particular research question or setting. previous research has provided valuable context for the development of new research instruments, also emphasizing the necessity to carefully discuss the pro and cons of using preexisting or newly developed measures e.g., [ ] . working conditions do not only influence the physical but increasingly impact the mental wellbeing of employees [ ] . the process of transforming to industry . with the resulting digitization and emergence of new forms of work (e.g., platform work, remote work, freelancers, home office) has been researched for the last decade and provided valuable insight in central issues or smes adapting to the accelerating change of the working environment (e.g., lack of operational capacity for systematic reorganization) [ , ] . moreover, the trajectory of climate change and the current covid- pandemic have accelerated these processes [ , ] . particularly the necessity of infection control has resulted in an even greater necessity of work-related mobility and flexibility and is expected to impact the working environment in the long term. as a result, employers and employees are facing new psychosocial risks, e.g., social isolation, increasing technical and social challenges related to electronic communication [ ] which has been related to the development of depression, anxiety, self-reported stress, and sleeping disorders [ ] . especially in smes, where frequently fewer (financial) resources are available compared to larger companies, the redesign and adaption of a continuously changing working environment is particularly challenging. new evidence of the effectiveness of workplace enhancements in the sme setting could facilitate necessary changes. the results of this review highlight that the various psychosocial factors in smes have been researched with varying intensity. as chirico [ ] pointed out in , the new work-related risks have not received sufficient attention from the scientific community. this can be recognized here by a lack of studies for the work characteristics "new forms of work" and "working environment". within the context of the current covid- pandemic, the relevance of these aspects becomes even more evident. smes from the economic sectors "professional, scientific and technical activities" and "wholesale and retail trade, repair of motor vehicles and motorcycles" should also be subject to more research, as they appeared to be underrepresented. due to the lower financial and human resources available in smes and a lower awareness of the resulting costs of inadequate health and safety management [ ] , research for cost-efficient and effective interventions to improve mental health in smes is of high relevance to convince entrepreneurs of the 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intervention strategy for workplace stress measurement instruments and data collection: a consideration of constructs and biases in ergonomics research institute of world health organization. health impact of psychosocial hazards at work: an overview; world health organization back to the future: policy pointers from platform work scenarios new forms of employment series, new forms of employment series; publications office of the european union living, working and covid- data european agency for safety and health at work. covid- : back to the workplace the work is associated with, but not funded by a project funded by the federal ministry of education and research of the federal republic of germany (bmbf gl a improvejob). many thanks to the four reviewers for their constructive and valuable suggestions during the review process of this manuscript. many thanks to anke wagner for her advice regarding the development of the search strategy and quality assessment of the papers. we would also like to thank the members of the seminar "health services research" (coordination centre for health services research, university hospital tuebingen) for their constructive feedback during the development of the research questions and the search string, and benjamin lee for his linguistic advice on the manuscript. the authors declare no conflict of interest. the funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. key: cord- - i uv authors: zhou, jacy; blaylock, rebecca; harris, matthew title: systematic review of early abortion services in low- and middle-income country primary care: potential for reverse innovation and application in the uk context date: - - journal: global health doi: . /s - - -z sha: doc_id: cord_uid: i uv background: in the uk, according to the abortion act, all abortions must be approved by two doctors, reported to the department of health and social care (dhsc), and be performed by doctors within licensed premises. removing abortion from the criminal framework could permit new service delivery models. we explore service delivery models in primary care settings that can improve accessibility without negatively impacting the safety and efficiency of abortion services. novel service delivery models are common in low-and-middle income countries (lmics) due to resource constraints, and services are sometimes provided by trained, mid-level providers via “task-shifting”. the aim of this study is to explore the quality of early abortion services provided in primary care of lmics and explore the potential benefits of extending their application to the uk context. methods: we searched medline, embase, global health, maternity and infant care, cinahl, and hmic for studies published from september to february , with search terms “nurses”, “midwives”, “general physicians”, “early medical/surgical abortion”. we included studies that examined the quality of abortion care in primary care settings of low-and-middle-income countries (lmics), and excluded studies in countries where abortion is illegal, and those of services provided by independent ngos. we conducted a thematic analysis and narrative synthesis to identify indicators of quality care at structural, process and outcome levels of the donabedian model. results: a total of indicators under subthemes were identified to examine the quality of service provision: law and policy, infrastructure, technical competency, information provision, client-provider interactions, ancillary services, complete abortions, client satisfaction. our analysis suggests that structural, process and outcome indicators follow a mediation pathway of the donabedian model. this review showed that providing early medical abortion in primary care services is safe and feasible and “task-shifting” to mid-level providers can effectively replace doctors in providing abortion. conclusion: the way services are organised in lmics, using a task-shifted and decentralised model, results in high quality services that should be considered for adoption in the uk. collaboration with professional medical bodies and governmental departments is necessary to expand services from secondary to primary care. in england and wales, the criminalisation of abortion persists as a source of stigma, discrimination against women, and hinders provision of patient-centred clinical practices [ ] . according to the abortion act, all abortions must be approved by two doctors, reported to the department of health and social care (dhsc), and can only be performed by doctors within licensed premises [ ] . this legal framework causes accessibility issues, especially in rural communities lacking in both medical facilities and providers, and prevents the development of other innovative models, such as nurse/midwife-led surgical services [ ] . the uk is unable to implement the who recommendation for services to optimise health worker roles in healthcare systems such as primary care because of the legal restrictions [ ] . at the cairo international conference on population and development (icpd), over governments agreed that reproductive health care should be an integral part of primary health care and should be accessible in all countries "to all individuals of appropriate ages as soon as possible and no later than " [ ] . several professional medical bodies, including the british medical association (bma), the royal college of gynaecologists and obstetricians (rcog), and the royal college of general practitioners (rcgp) [ ] [ ] [ ] , advocate for the decriminalisation of abortion in england and wales, stating that it will remove unnecessary barriers and improve the current clinical practice. following recent successes in expanding sexual and reproductive rights in the republic of ireland and northern ireland, there is increasing pressure to decriminalise abortion in england and wales [ , ] . this warrants the exploration of new service models which would be available after decriminalisation and could improve current practice. in low-and-middle-income countries (lmics), resource constraints motivate policymakers to rethink existing processes and make decisions that are cost effective [ ] . providers then leverage regulatory gaps to adopt "frugal innovations" [ ] . reverse innovation occurs when products/services that are highly effective and scalable penetrate marginalised markets of high-income countries (hics); and for service models, core elements are extracted and adapted for local conditions [ ] . abortion services have long been part of primary care in lmics and are sometimes "task-shifted" to mid-level providers (mlps), such as nurses or midwives. some studies from lmics have shown that surgical abortions (sa) can be safely and effectively performed by mlps in the primary care setting of lmics [ , ] . the advent of early medical abortion (ema) has further enabled the provision of safe abortion in a simple health facility with few requirements for technology or any surgical skills [ ] . understanding the potential value and challenges of reverse innovation for potential primary care abortion services in the uk is necessary to make strong evidence-based propositions for future policy and legislative changes [ ] . in this article, we will: systematically review the evidence base for firsttrimester abortion services in primary care of lmics, use a narrative synthesis approach to analyse the quality of abortion services with specific indicators organised around the donabedian model, and consider the opportunities and challenges for the development of such services in the uk. this systematic review was conducted using covidence™ [ ] , and in accordance with the prisma statement, refer to additional file [ ] . we searched databases medline, embase, global health, maternity and infant care, cumulative index to nursing and allied health literature (cinahl) and health management information consortium (hmic) (grey literature database) for studies published between september to february (additional file : full search strategy). all searches were limited to papers written in the english language. other relevant papers were identified by citation searching and reference checking. we used a pi(c)os framework to establish search terms and selection criteria (additional file : search terms and selection criteria) [ ] . the population was defined as all healthcare providers strictly in primary care settings, according to the who definition [ ] . studies in secondary and tertiary settings were excluded. ngo-led services were also excluded as they are semiautonomous and may be separate from formal healthcare systems depending on country. population was further refined by country, including those classified as "low income," "lower-middle income," and "upper-middle income", and those where abortion is not entirely prohibited (additional file : list of lmics) [ , ] . who recommends mg mifepristone administered orally, followed - days later by μg misoprostol administered vaginally, sublingually or buccally [ ] . the chosen cut-off date as the cairo international conference on population and development (icpd) was a turning point for sexual and reproductive health rights. governments were urged to impose less punitive measures on women seeking abortion, provide safe abortion services and measures to manage complications resulting from unsafe abortions. who defines primary care (pc) as the gate keeper to healthcare services and is where "first-contact, accessible, continued, comprehensive and coordinated care" occurs [ ] . according to the world bank according to world abortion law the intervention was defined as early abortion (medical or surgical), where "early" implies a pregnancy under weeks of gestation [ ] . no comparators were considered as this review is an exploration of existing literature. the outcome was defined as the quality of abortion services, including themes outlined by dennis et al. shown in table [ ] . only peer-reviewed primary studies were included. a list of excluded studies can be found in additional file . the quality of papers was assessed using a standardised checklist from the mixed methods appraisal tool (mmat) [ ] . this tool was chosen due to the heterogeneity of included papers. an extensive scoring guide and an overall quality score was given for each included study. a detailed assessment of each paper was also conducted, refer to additional file . a narrative synthesis analysis was used due to the heterogeneity of included studies. jz extracted the data using a standardised template and summarised the results narratively. rb was involved in identifying relevant themes and reaching a consensus on the data extracted. a thematic analysis was conducted to assess the quality of abortion services according to various quality various indicators at the structural, process, and outcome levels. table shows the indicators of quality abortion care used in this study. figure shows the prisma flow diagram of this study [ ] . an initial search yielded titles. sixty-nine studies were selected for full-text review and an additional studies were identified by forward and backward snowballing. we identified studies for inclusion, of which there were eight implementation studies, three cross-sectional studies, three prospective cohort studies, two qualitative studies and two randomised controlled trials (rct) (prisma diagram in fig. ). we describe the included study characteristics in table (see additional file for further details). included studies were conducted in eight countries -bangladesh [ ] , democratic people's republic of korea (dprk) [ ] , ethiopia [ ] , india [ , , , ] , kyrgyzstan [ ] , nepal [ , , , , , , , ] , nigeria [ , , ] and south africa [ ] . with reference to dennis et al. [ ] , we identified a total of indicators to assess the quality of abortion services in eight subthemes, organised under three table indicators of high-quality early abortion care explored in this review, adapted from dennis et al. [ ] theme subtheme indicators of high quality •abortion care must be accessible and not limited by administrative or policy barriers. •regulations, guidelines and other policy documents have been developed, approved by national/sub-national governments, and/or disseminated to health care facilities that are supportive of access to safe abortion care consistent with who guidance. •efficient, high-quality referral systems are in place. •essential equipment, supplies and medications are available in sufficient quantity to address needs. •abortion is provided in a facility with space for privacy. •appropriate pain management techniques are in place. •physical assessments of general and sexual and reproductive health are performed (including confirmation of gestational age). •staff follow approved guidelines and protocols for medical, surgical, and incomplete abortion. •staff use appropriate technologies. •follow-up care is provided, where client's experience with abortion and pregnancy status are assessed. •staff explain all aspects of abortion care to clients (current condition, treatment plan, follow-up needs, and potential post-abortion complications and how to obtain appropriate post-abortion care). •staff provide clients the opportunity to express concerns, ask questions, and receive accurate, understandable answers. •staff offer respectful care. •staff work to ensure privacy during the visit. •staff provide confidential care. •staff hold non-judgemental attitudes. •staff-client interactions promote an atmosphere of trust. ancillary services •staff directly provide or offer referrals for a range of sexual and reproductive health services, including contraception and screening and treatment for hiv and stis. outcome abortion outcomes •there is low number of admissions for treatment of abortion complications. •there is a low percentage of maternal deaths as a result of abortion a . •clients are satisfied with abortion care a according to who in , mortality rate due to unsafe abortion was at deaths per , live births ( %) worldwide. in developed regions, mortality rate due to unsafe abortion was . deaths per , live births ( %); in developing regions, mortality rate due to unsafe abortion was deaths per , live births ( %) [ ] sections: ( ) structural indicators: law and policy, infrastructure; ( ) process indicators: technical competency, information provision, client-provider interactions, ancillary services; ( ) outcome indicators: abortion outcomes, client satisfaction. the following is a narrative analysis of the abortion services and the contexts in which they operate, detailed in the included studies. lmics are disproportionately affected by restrictive abortion laws, therefore unsafe abortions are extremely common in affected countries and result in high maternal mortality rates. in response to this phenomenon, the bangladeshi government sanctioned "menstrual regulation" (mr), a process to remove the uterine lining using surgical or medical methods, whether the woman is pregnant or not, henceforth enabling one to legally seek help through primary care services [ ] . liberal abortion policies encourage safe abortion services and reduce maternal mortality [ ] . countries (india, ethiopia, nepal, kyrgyzstan, dprk, south africa) with liberal abortion law have well-established policies and guidelines for service provision [ - , - , - ] . nepal and ethiopia have distinguished themselves from the rest, both adopting proactive and liberal measures to integrate medical abortion (ma) services in their local healthcare system by implementing national guidelines and task-shifting services to mlps [ , , , , , , , ] but the results are vastly different. nepal became a widely successful case and a regional leader of innovative abortion services while ma services are still lacking in ethiopiaonly . % of providers surveyed have received abortion training, and a majority ( . %) felt uncomfortable working in a facility that provides abortion due to religious and personal reasons [ ] . while a supportive government is necessary to introduce new policies, sociocultural factors such as religion and moral believes can hinder their success. andersen et al. [ ] reported a third of trained auxiliary nurse-midwives (anms) did not provide ma due to the lack of appropriate equipment and medication in nepal. ma was rarely provided in nigeria due to the high costs of drugs and tighter restrictions, but clinics were wellequipped to provide sa for incomplete abortions [ ] . in south africa, high medication cost was also a barrier to ma provision [ ] . ma combination packs in india and bangladesh made self-medication safer and more intuitive for women, expanding its access to local pharmacies [ , ] . some primary care clinics were unequipped to manage ma complications, but all studies detailed referral systems to secondary or tertiary care [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . privacy in facilities is essential to creating a safe environment for women, especially in communities where abortions are strongly associated with shame and discrimination. three studies mentioned the lack of private space as an additional barrier to expanding ma services [ , , ]. yet, this was only made necessary in cohort studies and rct studies [ , , , , , , , , ] . no cross-sectional studies mentioned privacy, so its actual practice is lesser known. only andersen et al. reported the actual proportion of private rooms in their nepal study - % in primary health centres and % in health posts [ ] . technical competency ma is recommended by the who as a safe and effective method for abortion in the first trimester [ ] . while ma becomes increasingly popular globally, surgical methods remain popular in nigeria and india due to several reasons. ( ) providers have poor knowledge of ma regimen due to lack of training, i.e. most nigerian doctors are only familiar with misoprostol as a drug for stomach ulcers as it is not licensed for ma [ , ] ; and india has non-standardised ma treatment as providers often rely on their intuition or personal experience to determine the "correct" dosage and regimen [ ] . ( ) high cost of medication was a barrier to accessibility, especially in rural areas of india with severe lack of funding [ ] . ( ) a resistance to change, as providers still prefer surgical methods for being marginally "quicker and easier", and less prone to complications compared to ma [ , ] . ( ) the burden of responsibility placed on clients to self-manage their mahence providers may omit those who are uneducated (who may have difficulty comprehending instructions) and those living faraway (as heavy bleeding starts on the journey back home), as it can cause a greater inconvenience overall [ ] . several studies reported that nurses and midwives gained confidence with ma through ample training and practice, hence improving workflow [ , , , , , , , , ] . nevertheless, some suggested follow-up interventions to ensure long-term effectiveness, such as provider support networks and follow-up practice assessments [ , ] . several studies used an ultrasound scan to confirm gestational age of the pregnancy, but later have considered it unnecessary in most cases, consistent with who recommendations [ , , , , , ] . pain medication was provided to over % of clients in most cohort studies and rct studies [ , , ] , but actual practice may be as low as %, observed by banerjee et al. in india [ ] . ramachandar and pelto [ ] highlighted the importance of effective communication in ma as providers have less control over its outcome, relative to sa. this entails providing accurate and adequate information in a clear and concise manner to manage client expectations and reduce complications [ ] . in several studies, providers were trained to brief clients on the procedure, side effects and complications of abortion [ , , - , , , , - ] . however, actual practice largely depends on provider's knowledge and communication skills. banerjee et al. [ ] reported that % of providers explained the ma procedure to clients, % explained the possible side effects, and no providers counselled on complications. some providers were unsure of what constituted a complication and had various ways of classifying expected effects such as pain and bleeding: "some doctors did not have clear idea of what's normal bleeding" [ ] . although studies reported a majority of their clients were at least "somewhat prepared" for the procedure in india and kyrgyzstan, other studies in nepal and bangladesh show that some clients experience ma with unaddressed questions [ , , , ] . clients in india and nepal experienced judgement from providers and were treated with disrespect due to the stigma associated with abortion in some contexts [ , ] . one provider restricted ma by the clients' social status and education level, believing urban clients can better comprehend the instructions [ ] . since selfmedication places a greater emphasis on client knowledge, selectively providing ma may reduce mismanagement, but may inadvertently deprive women in lower social status of ma, especially those in challenging situations, such as aborting without a partner's or family's consent. providers who ensured confidentiality improved client's trust and comfort during the abortion process. in nepal, the majority of clients valued the confidential support in clinics as they could receive abortion without informing their family members [ , ] . nurses/midwives-led services also improved trust and built strong rapport with women within local communities, as they were posted to each health stations longer than physicians [ , ] . provision of contraception may be as low as %, reported by benson et al. across nigeria, nepal and india [ ] . short-term contraceptives such as condoms, pills and injectables are popular with clients, whilst longacting reversible contraceptives (larc) such as intrauterine devices and implants are less popular [ , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] ] . one study claimed that given the poor accessibility to health facilities in rural areas, expanding the provision of larc is important to prevent any unwanted pregnancies [ ] . the majority of studies showed at least a % complete abortion rate, consistent with the international benchmark [ , - , , , , ] . only one study failed to meet %, attributed to the provider's lack of experience with ma. all incomplete abortions were either resolved by surgical aspiration in the primary care clinic itself or through a referral to a hospital [ , - , , , , ] . most clients were satisfied with the abortion services they received and would recommend them to their friends [ , , , , ] . although satisfaction levels were subjective to clients, tamang et al. [ ] showed that high satisfaction rates were related to experiences of shorter length of abortion, a less-thanexpected amount of bleeding and high-quality counselling. sa outcomes were not investigated as cross-sectional studies did not allow for patient follow-up [ , ] . in this review, we explored the quality of first-trimester abortion services provided in primary care clinics of lmics, using indicators organised around the donabedian model. in this service model, we observed an efficient workflow that optimised workforce while ensuring safety and client satisfaction. compared to the classic linear relationship in a donabedian's model, our results postulate a mediation pathway where good structure directly promotes good outcome and process, which in turn also promotes good outcome [ ] . this pathway underscores the importance of structural components, but our review also showed that policies and infrastructure are insufficientfor example, in countries such as ethiopia where pro-choice government policies do not necessarily result in accessible abortion services. many doctors in nigeria and india still favoured sa, and some clinics were well-equipped to perform mva in the event of incomplete abortion. we cannot comment on provider's competency and knowledge of sa as there was little evidence in the recent literature. as the worldwide trend changes from sa towards ma, our review shows that these components are essential for quality ma services: ( ) a safe and private space to ensure client confidentiality for in-clinic abortion, due to its longer duration relative to sa; ( ) a standardised understanding of arbitrary side effects, such as bleeding and pain; ( ) a strong rapport between clients and providers as ema focuses on self-medication. multiple studies also showed the success of taskshiftingnurses and midwives can effectively replace doctors in abortion services when well-trained and supported. redistributing low-skilled tasks can optimise efficiency and improve work satisfaction across all providers, thereby combatting healthcare workforce shortages [ ] . passing tasks to midwives and nurses can also build a stronger rapport between provider and clients as they are sometimes able to commit to a local community in the longer-term [ ] . task-shifting is increasingly feasible with the popularity of ma as it requires less technical skills than sa [ ] . shifting the task to well-trained mlps expands the provider network, thereby increasing service availability. this review showed that provision of first trimester ma (ema) in primary care services is safe, feasible and acceptabledecentralising abortion services to primary care and task-shifting will increase availability and accessibility. in the us, studies support the integration of ema into its primary care system as it essentially uses skills that primary care providers already practice [ , ] . some countries, such as australia, france, and the netherlands, already provide ema in primary care clinics [ ] [ ] [ ] . in england and wales, primary care teams in general practice (gps) or sexual health clinics (shcs) already provide counselling, pre-abortion screening, and referral into abortion services [ ] . former rcog president, anthony falconer expects the line between primary and secondary women's healthcare to become fuzzier with more "gynaecological issues" resolved within the community, and the rcog also proposed a "life-course approach" to women's health starting in primary care [ , ] . in recent years, members of parliament across the house of commons have shown overwhelming support for the decriminalisation of abortion [ , ] . if this is achieved, ema services will potentially expand to primary care and align with the nhs long term plan, aimed at facilitating a stronger collaboration between primary and secondary care service for an integrated approach [ ] . this expectation necessitates secondary-based trainings for primary healthcare practitioners to ensure technical competency. in rcog's workforce survey of uk consultants, only . % (around % of ob/gyn specialists) included abortion as part of their work [ ] . expanding ema services to gp clinics would increase the number of trained health professionals that perform simple abortion procedures, freeing up specialists for more urgent, complicated cases, such as those seeking abortion in later in pregnancy. nevertheless, some challenges need to be addressed while implementing change. convincing stakeholders of the potential value that "frugal innovations", such as task-shifting, can bring to the nhs is complex. innovations from lics are often discounted or given shorter shrift, and research from these settings is rated worse based on their country of origin [ ] [ ] [ ] , complicating the diffusion of learning from these contexts. nonetheless, the extensive experience of primary care ema in these countries suggests that there is much that could be learned by the uk. there is a risk that introducing ema into primary care in the uk may increase burden on gp clinics, already face issues of long-waiting hours and workforce shortages. careful planning would be required to ensure that additional services do not result in a greater inefficiency and cost to the nhs. our review had several limitations. first, a disproportionate number of ma papers were included thus less is understood on sa services in primary care due to a paucity of evidence. we also excluded services delivered in ngo clinics as they were not strictly primary healthcare but are often similar in make-up to primary care clinics and sometimes, the sole providers of abortion services in some lmics. second, a majority of included studies were in a controlled environment, where provider practice was standardised by strict protocolstherefore, results may not represent actual practice, and this also reflects a gap in the current literature as more cross-sectional studies should be conducted to give a full picture. lastly, only two of the studies were qualitative studies, but they contributed more insight in our review as their narrative form provides a deeper understanding of the phenomenon compared to quantitative studies. our review is the first to consolidate quality of abortion services provided in primary care clinics of lmics. using the dennis et al. framework, we determined the components necessary for a successful abortion service in primary care clinics. overall, we conclude that ema provision in primary care is safe and feasible, and that implementing a similar service in the uk could improve access without compromising on quality. the next steps would be a cost estimation of integrating an ema service into gp clinics, and an economic evaluation to make a strong business proposition. acceptability and feasibility studies would be required to explore the underlying conditions of primary care ema. qualitative studies would also provide an in-depth understanding of attitudes primary care providers and women have towards primary care ema. the recent covid- outbreak further builds a strong case for changing policies to match the evidence base. telemedical ema was approved in england, scotland and wales, so women can now receive ema at home, via nurse-led telephone consultations and medical abortion packs sent in the post [ ] . the temporary approval of this service sets a precedent for abortion-service innovation, and moving forward, we believe implementing ema in the uk primary care system can complement telemedical services to provide women with face-to-face care in their own community. we also further recommend that further research is conducted to inform and enable taskshifting of first trimester surgical abortions to nurses and midwives in uk primary care. supplementary information accompanies this paper at https://doi.org/ . /s - - -z. the decriminalisation of abortion: an argument for modernisation abortion statistics for england and wales accessed 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obstetricians and gynaecologists the nhs reforms: what they will mean for generalist and specialist clinicians abortion rights are on the ballot this general election -years-since- -abortion-act-passedmajority-of-mps-now-have-a-more-liberal-position-on-abortion royal college of obstetrician and gynaecologist. call for evidence on abortion in the developing world and the uk review of operational productivity in nhs providers: interim report judgment under uncertainty: heuristics and biases does a research article's country of origin affect perception of its quality and relevance? a national trial of us public health researchers accessed explicit bias toward high-income country research: a randomised, blinded, crossover experiment in english clinicians the abortion act : approval of a class of places publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations additional file appendix s . . medline search strategy (via ovid). appendix s . . embase search strategy (via ovid). appendix s . . global health search strategy (via ovid). appendix s . . maternal and infant care search strategy (via ovid). appendix s . : health management information consortium search strategy (via ovid). appendix s . . cinahl (via ebsco). appendix s . prisma checklist. all authors were involved in study design, drafting of manuscript, providing comments and suggestions for the review. rb originated the study. mh and rb provided guidance on the framework and direction of the review. rb wrote and redrafted manuscripts and reviewed articles. jz conducted literature searches, reviewed articles, wrote and drafted the manuscripts. the author(s) read and approved the final manuscript. the authors received no funding for this article. mh is supported in part by the nw london nihr applied research collaboration. imperial college london is grateful for support from the nw london nihr applied research collaboration and the imperial nihr biomedical research centre. the views expressed in this publication are those of the authors and not necessarily those of the nihr or the department of health and social care. key: cord- -j fv u d authors: dietler, dominik; lewinski, ruth; azevedo, sophie; engebretsen, rebecca; brugger, fritz; utzinger, jürg; winkler, mirko s. title: inclusion of health in impact assessment: a review of current practice in sub-saharan africa date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: j fv u d natural resource extraction projects, including those in the mining sector, have various effects on human health and wellbeing, with communities in resource-rich areas in sub-saharan africa (ssa) being particularly vulnerable. while impact assessments (ia) can predict and mitigate negative effects, it is unclear whether and to what extent health aspects are included in current ia practice in ssa. for collecting ia reports, we contacted mining projects and ministries regulating the mining sector. the reports obtained were complemented by reports identified in prior research. the examination of the final sample of ia reports revealed a heavy focus on environmental health determinants and included health outcomes were often limited to a few aspects, such as hiv, malaria and injuries. the miniscule yield of reports ( . % of contacted projects) and the low response rate by the contacted mining companies ( %) might indicate a lack of transparency in the ia process of the mining sector in ssa. to address the shortcomings identified, policies regulating ia practice should strengthen the requirements for public disclosure of ia reports and promote a more comprehensive inclusion of health in ia, be it through stand-alone health impact assessment or more rigorous integration of health in other forms of ia. impact assessment (ia) is an established approach to minimize adverse environmental, social and health impacts of projects, policies and programs, while fostering opportunities for equitable and sustainable development [ ] [ ] [ ] . the first legislation promoting ia dates back more than years, when legislation on environmental impact assessment (eia) was introduced in the united states [ ] . passed in , this legislation required human health to be included as part of the assessment. since then, the field of ia has evolved and diversified. during the s, the social impact assessment (sia) approach was established, placing particular emphasis on the interrelations between the environmental and social impacts, including health [ , ] . with the aim to more specifically address potential impacts of projects, programs, plans and policies on human health as a stand-alone process, health impact assessment (hia) was introduced in the late s/early s [ , [ ] [ ] [ ] . over the past years, the methodology and approach for assessing health impacts has been further developed [ ] . at present, for member countries of the extractive industries transparency initiative (eiti), a request to their contact person was sent. all messages were sent either through a contact form on the company/ministry web page or directly by e-mail. a maximum of two reminders at an interval of at least weeks were sent if the contacts did not respond to the initial message. the messages to the companies were sent between november and may , those to the ministries and eiti representatives between may and july . publicly available reports were searched online through google and company web pages. in the google search engine, a systematic online search was conducted using boolean operators. separately for each country in ssa, the term "impact assessment" and terms representing an activity of natural resource extraction projects ("natural resource or mine or mining or dam or drilling or gas or hydrocarbon or oil or petrol or hydroelectricity or hydropower or biofuel or electricity or exploration or exploitation or extraction") were combined with the different spellings for the respective country (e.g., "côte d'ivoire" or "ivory coast"). initial piloting of the search methodology revealed that most of the relevant documents were found among the first hits. of note, this search terminology also served another research component that systematically searched contents of ia reports of a broader spectrum of large natural resource extraction projects [ ] . for the current analysis, the full sample of reports retrieved was reduced to include mining projects only. the search was carried out in october and november in switzerland. additionally, the web pages of the contacted companies were visited to check the public availability of ia reports. if no direct link to the company was available in the mining database, the project and the company operating or owning the project were searched on google. all web pages were visited in may . an ongoing research initiative, the "health impact assessment for sustainable development" (hia sd) project [ , ] aims at generating a deeper understanding of health impacts of natural resource extraction projects in burkina faso, ghana, mozambique and tanzania. as part of the research activities, in-country project partners established contacts with mining companies and ministry representatives and obtained reports between march and january . as a result, ia reports were made available either directly by the companies or by the national environmental authorities. request to their contact person was sent. all messages were sent either through a contact form on the company/ministry web page or directly by e-mail. a maximum of two reminders at an interval of at least weeks were sent if the contacts did not respond to the initial message. the messages to the companies were sent between november and may , those to the ministries and eiti representatives between may and july . publicly available reports were searched online through google and company web pages. in the google search engine, a systematic online search was conducted using boolean operators. separately for each country in ssa, the term "impact assessment" and terms representing an activity of natural resource extraction projects ("natural resource or mine or mining or dam or drilling or gas or hydrocarbon or oil or petrol or hydroelectricity or hydropower or biofuel or electricity or exploration or exploitation or extraction") were combined with the different spellings for the respective country (e.g., "côte d'ivoire" or "ivory coast"). initial piloting of the search methodology revealed that most of the relevant documents were found among the first hits. of note, this search terminology also served another research component that systematically searched contents of ia reports of a broader spectrum of large natural resource extraction projects [ ] . for the current analysis, the full sample of reports retrieved was reduced to include mining projects only. the search was carried out in october and november in switzerland. additionally, the web pages of the contacted companies were visited to check the public availability of ia reports. if no direct link to the company was available in the mining database, the project and the company operating or owning the project were searched on google. all web pages were visited in may . an ongoing research initiative, the "health impact assessment for sustainable development" (hia sd) project [ , ] aims at generating a deeper understanding of health impacts of natural resource extraction projects in burkina faso, ghana, mozambique and tanzania. as part of the research activities, in-country project partners established contacts with mining companies and ministry representatives and obtained reports between march and january . as a result, ia reports were made available either directly by the companies or by the national environmental authorities. in a first step, the eligibility of the reports was assessed. reports were excluded if (i) not all ia reports were available for projects for which multiple assessments were conducted (e.g., only sia was available that was conducted in connection with an eia); (ii) it represented only a summary of the assessment (e.g., environmental impact statement); or (iii) the project was not rated as a category a project according to the international finance corporation (ifc)'s environmental and social categorization, so that the sample includes only projects "with potential significant adverse environmental or social risks and/or impacts that are diverse, irreversible, or unprecedented" [ , ] . category a projects, such as most large-scale mining projects, are required to conduct a comprehensive ia, including a thorough assessment and data collection for informing potential health impacts [ , ] . more specifically, in contexts where availability and quality of health-related data are limited, the collection of primary data in affected communities is indicated for ensuring a robust evidence-base for the ia and enabling monitoring of health impacts over time [ ] . the second step comprised of examining the full ia reports for their consideration of different health factors. additionally, to assess the completeness of the executive summaries, the summaries of the ia reports found through the google search were screened separately. the screening followed the same methodology for both, the full ia reports and the sample of executive summaries. for each report section (e.g., baseline, impact assessment, mitigation measures and monitoring plan), information on the inclusion of different health aspects was extracted. an adapted analysis framework from quigley et al. [ ] , the ifc hia guidelines [ ] and winkler et al. [ ] was used, which comprised health determinant categories (table a ) and health outcome groups (table a ). in total, specific health determinants and health outcomes were identified. furthermore, the data sources that the ias used for the health baseline assessment were categorized into different primary and secondary data source categories. the primary data sources consisted of key informant interviews (kiis), focus group discussions (fgds), household surveys (hhs) and biological or environmental samples, including field observations. the options for the secondary data sources included routine health surveillance data (e.g., health facility data, district health information system (dhis ) data), national and regional surveys (e.g., demographic and health surveys (dhs) and multiple indicator cluster surveys (mics)), official government statistics (national or local), peer-reviewed articles and grey literature. other data sources that might be relevant were classified as "other primary data source" and "other secondary data source". full reports that were electronically available were screened by two authors (d.d. and r.l.), while executive summaries were examined by a third author (s.a.). case study reports that were only available in printed form were examined by the hia sd project research associates in the respective countries. parallel screening of the reports and validation of the results ensured the consistent application of the methodology across all assessors. to facilitate data entry during the screening stage, the assessors used an online survey tool (www.surveymonkey.com). the survey data were extracted and summary statistics generated using r version . . (r foundation for statistical computing, vienna, austria) [ ] . the unit of analysis were the projects. hence, if more than one ia report was available for a specific project (e.g., a hia was conducted together with an eia), the health aspects included in the different reports were combined. the statistics are presented for different aspects for each health determinant and outcome. comparisons were made between the different report sections and report types (health-specific ia (hia and eshia) vs. non-health-specific ia (eia, sia or esia)). as shown in figure , a total of ia reports were obtained. reaching out to contacts of mining projects and representatives from ministries in countries of ssa yielded only and reports, respectively. through the systematic google search, reports were found. additionally, the ia reports of companies were readily available on company web pages. the sample was completed by reports obtained from case studies in the hia sd project. among the case study reports, were also found on the company web pages and were made available by company contacts. furthermore, report was shared directly by a company contact and publicly on the web page. two reports were excluded from the analysis because only part of the ia documents were available. additionally, reports considered only the expansion of existing projects and, thus, did not necessarily require a full ia (i.e., not category a projects). our final sample included ia reports. panel a in figure shows the geographic distribution of the included ia reports as well as the location of the contacted mining projects in ssa. reports from different countries were obtained. most reports stemmed from the hia sd project countries, namely ghana (n = ), burkina faso (n = ), mozambique (n = ) and tanzania (n = ). furthermore, a sizable number of reports of projects in malawi (n = ) and the democratic republic of the congo (n = ) were shared. of note, despite hosting the vast majority of mines listed in the s&p mining database (n = ) very few reports (n = ) could be retrieved from south africa. a broad variety of ia report types were collected (see figure , panel b). for some projects, more than one type of ia report was available. most of the reports were eias (n = ), which were often conducted alongside sia, hia and esia. only reports were obtained that addressed health by design (i.e., hia and eshia). a temporal pattern is visible in the publication year of the ia reports (see figure , panel c). most of the reports were published in or later (n = ). only of the reports were published before . figure provides an overview of the percentage of ia reports considering the screened health determinants. large differences were observed between the health determinants. while the environmental determinants were considered in most ia reports, the social determinants and institutional factors were less often included. some particular aspects received little attention, including the capacity of maternal and child health services, as well as access and capacity of traditional health services. the impacts on individual health risk factors, such as alcohol consumption, tobacco or drug use, were least frequently assessed. overall, the number of health determinants considered decreased with later sections of the ia reports (i.e., mitigation and monitoring plan). the average percentages of health determinant items included were . %, . %, . % and . % in the baseline description, impact assessment section, mitigation plan and monitoring plan, respectively (see table a ). health outcomes were less frequently included in the ia reports than health determinants ( figure and table a ). overall, a third ( . %) of health outcomes were considered across the report sections, compared to . % for the health determinants. in the ia chapters, only . % of health outcomes were included. figure provides an overview of the percentage of ia reports considering the screened health determinants. large differences were observed between the health determinants. while the environmental determinants were considered in most ia reports, the social determinants and institutional factors were less often included. some particular aspects received little attention, including the capacity of maternal and child health services, as well as access and capacity of traditional health services. the impacts on individual health risk factors, such as alcohol consumption, tobacco or drug use, were least frequently assessed. overall, the number of health determinants considered decreased with later sections of the ia reports (i.e., mitigation and monitoring plan). the average percentages of health determinant items included were . %, . %, . % and . % in the baseline description, impact assessment section, mitigation plan and monitoring plan, respectively (see table a ). health outcomes were less frequently included in the ia reports than health determinants ( figure and table a ). overall, a third ( . %) of health outcomes were considered across the report sections, compared to . % for the health determinants. in the ia chapters, only . % of health outcomes were included. colors represent the percentage of reports or report sections considering the specific health aspect. red shading indicates percentages below %, blue shadings above %. acc. = access; cap. = capacity; cd = communicable disease; mch = maternal and child health; resp. = respiratory; trad. = traditional. in impact assessment reports. colors represent the percentage of reports or report sections considering the specific health aspect. red shading indicates percentages below %, blue shadings above %. acc. = access; cap. = capacity; cd = communicable disease; mch = maternal and child health; resp. = respiratory; trad. = traditional. only health outcomes were included in more than % of the reports. among them were, in decreasing order, hiv/aids, traffic-related injuries, work-related injuries, malaria, diarrhea, acute respiratory infections, tuberculosis and undernutrition. zoonoses, mental health, non-communicable diseases and vector-borne diseases other than malaria received less attention. similarly to the health determinants, health outcomes were more often considered in the baseline and impact assessment chapters than in the mitigation and monitoring plans. mitigation measures for specific health outcomes were proposed in few of the ia reports. figure shows the percentages of different data sources used as baseline indicators among the ia reports considering the respective health determinants or outcomes. overall, primary data were collected predominantly for the health determinants. for measuring health outcome indicators, primarily secondary data sources were used. collection of primary data pertaining on baseline conditions among the potentially affected communities through participatory approaches, such as kiis, fgds or hhs, was rare (see also table a ). for all health-related aspects, peer-reviewed literature was consulted in only a few instances. for the assessment of environmental determinants (e.g., air quality, water quality and quantity or noise) a comprehensive sample collection was often conducted. in some cases, these aspects were even assessed in separate specialist reports. in contrast, qualitative information from kiis and fgds were more often used to assess the social determinants of health. for some aspects related to access and capacity of public services (e.g., health and education), secondary data, such as official statistics, were also used. in most cases, secondary information for the baseline of specific health outcome indicators stemmed from health facility data or official statistics. if primary data were used, it was mostly qualitative data obtained from kiis or fgds. . data sources used for assessing health aspects in impact assessment reports. the height of the bars indicate the percentage of reports using any primary (blue bars) and any secondary (red bars) data source for the different health aspects. bar widths indicate the number of reports considering the specific health aspect (used as denominator for determining the bar height of the respective aspect). acc. = access; cap. = capacity; mch = maternal and child health; resp. = respiratory; trad. = traditional the differences in the percentages of ia reports addressing the various health aspects in health-specific ia (i.e., hia and eshia; n = ) and non-specific ia (i.e., eia, esia and sia; n = ) are shown in figure . almost all health determinants and outcomes were more prominently featured in the ia reports addressing health by design. among the health determinants, aspects related to access and capacity of traditional health services were included more frequently in health-specific ia reports. the differences were less pronounced for the environmental determinants of health. with regards to the health outcomes, of studied items were more often considered in projects for which a health-specific ia was conducted. differences of at least percentage points were observed for tuberculosis, arboviral diseases (e.g., chikungunya, dengue and yellow fever), the non-communicable diseases diabetes and chronic respiratory diseases, anemia and tuberculosis. on the other hand, work-related injuries were featured more often in projects for which no health-specific ia was conducted. figure . difference in percentages of impact assessment (ia) reports including the different health determinants and health outcomes between health-specific ia reports and non-health-specific ia reports. blue bars indicate more frequent consideration of the respective health determinant/health outcome in health-specific ia reports; red bars indicate more frequent consideration in non-health-specific ia reports. missing bars indicate a difference of %. acc. = access; cap. = capacity; eshia = environmental, social and health impact assessment; hia = health impact assessment; mch = maternal and child health; resp. = respiratory; trad. = traditional. the representation of health aspects in the executive summaries of the ia reports was analyzed and compared to their corresponding full reports ( figure ). the executive summaries frequently omitted information on the different health determinants and health outcomes, although they were included in the full texts. similar to the full texts, the executive summaries mainly featured information on environmental determinants of health. some health outcome categories, such as soil-, water-and waste-related diseases, non-communicable diseases, food-and nutrition-related diseases, maternal and child health or mental health, were not included in the executive summaries despite some full reports having considered these aspects (indicated as missing bars in figure ). leishmaniasis, hepatitis a/e, food-borne diseases and self-harm/suicide were excluded from this analysis because they were not considered in any of the full texts. overall, ia reports from countries in ssa were obtained from various sources and analyzed for the inclusion of health. we reached out to as many as mining projects and ministries. however, only reports were obtained from these contacts and sources. public access to ia reports on the internet was also limited; only ia reports were readily accessible online. screening of the reports revealed a heavy focus on environmental determinants of health. health outcomes were considered to a lesser extent than the health determinants. still, some health outcomes, such as malaria, hiv, diarrheal diseases or injuries, were more frequently included. furthermore, other health aspects, such as zoonoses, mental health issues, non-communicable diseases and food-and nutrition-related issues, received little attention. reports that had a specific focus on health (i.e., hia and eshia) addressed substantially more health aspects than other reports. primary data were frequently collected along with secondary data as indicators for the health determinants, particularly for environmental factors. for health outcomes, primary data collection was the exception rather than the norm. participatory data collection approaches with affected communities through kiis, fgds or hhs were rarely conducted. the ifc's sustainability framework through its performance standards on environmental and social sustainability sets out the requirements for the management of environmental and social risks of industrial investment projects [ ] . the ifc performance standards have been adopted by the equator principles financial institutions (epfi), a consortium that currently embraces more than banks and financial institutions [ , ] . since the ifc's sustainability framework is considered an international benchmark for identifying and managing environmental, social and health risks [ , ] , this standard is also applied in this discussion chapter for reflecting on our findings stemming from a comprehensive review of the available ia reports. the ifc performance standards require projects to publicly disclose information on project-related risks and impacts to affected communities [ ] . the scope of this information can range from full ia reports to short summaries of findings, depending on the project size and magnitude of anticipated impacts [ ] . for ifc-funded projects, the bank itself publishes a summary of the main findings of the ia [ ] . in our study, only a miniscule . % of the contacted large-scale mining projects shared their report, while more than % did not respond at all to our data inquest, despite an offer of strict confidentiality. the extremely low yield of ia reports indicates that there is a lack of transparency in current ia practice in the mining sector of ssa. research on public disclosure in ia practice from low-human development index (hdi) countries is scarce. in myanmar, a lack of public disclosure of eia reports conducted for the oil and gas sector was described, although improvement has been seen in recent years [ ] . instead of disclosing the full ia reports, often, only the executive summaries are published, thereby fulfilling the minimum requirements set out in the ifc performance standards. however, our results indicate that these summaries do not offer sufficient insights to inform the public about the potentially broad set of impacts on health. hence, more stringent requirements for public disclosure of the full ia reports would contribute to increase the accountability of large industrial mining companies and other large-scale infrastructure projects [ ] . hence, in addition to legal texts regulating ia practice, the need for public disclosure of full ia reports for projects should also be more explicitly demanded in policies and guidelines of international financing institutions (e.g., ifc), industry peak bodies (e.g., international council on mining and metals) and private companies. for large-scale projects (i.e., category a) the ifc performance standards [ ] and the world bank's operational policies [ ] further require a comprehensive assessment of the project impacts, including aspects of human health and safety. furthermore, different guidance and scientific documents promote a comprehensive approach to health in hia, covering the full spectrum of aspects determining human health, especially in complex social-ecological contexts of ssa [ , , ] . in our sample of ia reports, on average only about a third of investigated health outcomes were included and among the health determinants there was a strong focus on the physical environment. moreover, when health was integrated in other types or ias (i.e., eia, esia and sia), a more narrow range of health aspects were covered. this pattern has been seen in other parts of the world. for example, a lack of inclusion of health aspects was found in eia reports from the united states [ ] , australia [ , , ] and vietnam [ ] . furthermore, the assessment of health impacts within eias from australia was mainly limited to risks related to the physical environment [ ] . consistently, in hias from low-and middle-income countries, a lack of consideration of the social determinants of health was seen [ ] . this may be linked to the limited technical expertise to conduct hia in many parts of the world [ ] . in order to address this constraint, hia capacity building efforts are needed that do not only aim to build up technical capacity among ia practitioners but also provide trainings to regulators in governments and international financing institutions to appraise ia reports from a health perspective [ , ] . the strengthening of regulatory frameworks that specify under what circumstances hia is required, and to what extent, could be an important initial step for triggering the demand in hia capacity building in resource-rich countries of ssa [ , ] . finally, in light of the health aspects currently not included in ia practice, it should be reflected whether national and international ia guidance documents provide sufficient details on the scope of health to be considered in the ia process. a comprehensive assessment of health impacts, as required by the ifc performance standards, comprises data collection on health aspects in affected communities [ , ] . particularly in mining areas in low-hdi countries, the demographic, social-economic, environmental and epidemiological characteristics further warrant the collection of additional local-level data [ ] . however, in the ia reports obtained and scrutinized in the present study, primary data were predominantly collected for aspects related to the physical environment. for health outcomes, the assessments often relied on secondary data sources, such as coarse national and regional-level statistics or local health facility data. although these data sources hold considerable potential for monitoring health indicators, they are prone to low data quality [ , ] . the collection of local-level data by means of kiis, fgds and hhs is an additional means to engage affected groups in the ia process and can help identify and address local health impacts among vulnerable and marginalized populations [ ] [ ] [ ] [ ] [ ] [ ] . comprehensive baseline health data collection requires broad public health expertise among practitioners conducting the ia [ , , ] . however, health specialists in countries of ssa are rarely engaged in ia and often have limited awareness and knowledge about the ia process [ ] . for the health sector to be more actively engaged in hia, capacity building efforts should reach out beyond the public health sector (e.g., actors in overseeing ministries) to increase the understanding of the skill set required for conducting a thorough assessment of health impacts [ , ] . for this study, we attempted to pursue the different options that affected community members have at their disposal for accessing ia reports. physical contacts with project proponents or local authorities within the countries may potentially have increased the yield of reports. however, given that only % of companies responded to our data inquiry indicates that project representatives are difficult to approach. the resulting small and geographically clustered sample of ia reports limits the representativeness of our sample from which we derive our conclusions. furthermore, the analysis only assessed whether and to what extent health issues were addressed. an analysis of the interrelationships between the different health aspects or of the quality of the assessment itself (e.g., the necessity of primary data collection) was beyond the scope of our study. for conclusively judging the appropriate use of different data sources, a more in-depth study is needed, taking into account local characteristics and the quality of alternative data sources. this comprehensive review of ia reports of mining projects in ssa points at three main shortfalls of current ia practice: (i) lack of transparency; (ii) narrow scope of considered health aspects, with a strong focus on the physical environment; and (iii) lack of local-level primary data collection on health outcomes. there are different potential approaches to address these shortcomings at the national and international level. at the national level, ministries overseeing ia should reconsider how health is addressed in regulatory frameworks and policies regulating ia practice. this should include critical reflections on whether there is sufficient specificity provided in terms of methodological guidance on how to assess health impacts (i.e., the width (range of potential impacts) and depth (quality of the evidence-base) of the assessment) either in hia as a stand-alone approach or integrated in other forms of ia. furthermore, there is a need to understand whether existing frameworks provide sufficient guidance as to which expertise is needed for leading the assessment of health impacts. in addition, regulatory frameworks should be revised if they do not sufficiently promote disclosure of ia findings, with particular considerations for health-related information. at the international level, financing institutions, such as the ifc and the members of the epfi, can play a crucial role in closing the identified gaps. this can be done by setting and enforcing more stringent requirements for public disclosure of full ia reports along with strengthening guidance on how health needs to be included in different forms of ia in order to achieve consistency in quality. finally, any efforts in promoting more rigorous inclusion of health in ia must be coupled with hia capacity building, which appears particularly salient in the currently environment-dominated impact assessment practice in ssa. improving international standards for hia lays a foundation to improve global relationships; health outcomes for local communities need to be prioritized in order to create long-term, sustainable economic investment opportunities. we encourage other groups who pursue ia in the mining and other sectors in ssa and elsewhere to specifically address health, which cannot be emphasized enough in the current covid- pandemic. acknowledgments: the authors would like to thank our partners in burkina faso, ghana, mozambique and tanzania that were engaged in the collection and screening of the ia reports for the hia sd case study. further, we want to thank all of the people within the ministries and mining companies that have taken their time to accommodate our request. the authors declare no conflict of interest. the funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. table a . health determinant categories. factors related to the individual's biology and behavior. these comprise for example gender, age, ethnicity, dietary intake, level of physical activity, tobacco use, alcohol intake, personal safety, sense of control over own life, employment status, educational attainment, self-esteem, life skills, stress levels, resilience and risk behavior. conditions in which people are born, grow, live, work and age. these include access to services and community (health, education, nutrition, institutional and social support, social and health insurance); income/unemployment rate; distribution of wealth; empowerment of women; sexual customs and tolerance; racism; attitudes to disability; trust; sites of cultural and spiritual significance. environmental determinants of health physical, chemical, and biological factors external to a person, and all the related factors impacting behaviors, such as exposure to heavy metals, pesticides and other compounds, solvents or spills and releases from road traffic; air pollution (indoor and outdoor); noise pollution and exposure to malodors. it also includes factors, such as inadequate housing, water and sanitation services, and the mixing of population groups with different levels of communicable diseases which can be associated with in-migration. availability of services, including (traditional) health services, transport and communication networks; educational and employment; environmental and public health legislation; environmental and health monitoring systems; laboratory facilities; social and health insurance schemes. cds = communicable diseases; env. = environmental; mch = maternal and child health; mnch = maternal, neonatal and child health; n.a = not applicable; trad. = traditional. percentages are illustrated on a color scale from red to blue. red shading indicates percentages below %, blue shadings above %. social impact assessment: the state of the art. impact assess proj health impact assessment: the state of the art. impact assess proj environmental impact assessment: the state of the art health impact assessment in relation to other forms of impact assessment differing forms, differing 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united nations development programme standard & poor's global. market intelligence platform investigating the inclusion of health in impact assessment reports of natural resource extraction projects in sub-saharan africa; term paper health impact assessment for promoting sustainable development: the hia sd project investigating health impacts of natural resource extraction projects in burkina faso op . -environmental assessment international finance corporation. interpretation note on environmental and social categorization international finance corporation. introduction to health impact assessment; international finance corporation a language and environment for statistical computing; r foundation for statistical computing equator principles association members & reporting the equator principles: a financial industry benchmark for determining, assessing and managing environmental and social risk in projects barbarians at the gate: storming the gothenburg consensus social impact management plans: innovation in corporate and public policy. environ. impact asses international finance corporation: access to information policy evaluation of the environmental impact assessment system and implementation in myanmar: its significance in oil and gas industry. environ. impact asses who regional office for europe health impact assessment: main concepts and suggested approach: the gothenburg consensus paper health impact assessment international best practice principles inclusion of health in environmental impact assessment of major transport infrastructure projects in vietnam systematic literature review of health impact assessments in low and middle-income countries assessing health impacts in complex eco-epidemiological settings in the humid tropics: modular baseline health surveys. environ. impact asses using district health information to monitor sustainable development participation in health impact assessment: objectives, methods and core values public participation and environmental impact assessment: purposes, implications, and lessons for public policy making. environ. impact asses drawing from the well of community participation: an evaluation of the utility of local knowledge in the health impact assessment process community participation in health impact assessment. a scoping review of the literature. environ. impact asses towards environmental health equity in health impact assessment: innovations and opportunities health impact assessment and health equity in sub-saharan africa: a scoping review changing patterns of health in communities impacted by a bioenergy project in northern sierra leone experience and lessons from health impact assessment guiding prevention and control of hiv/aids in a copper mine project, northwestern zambia this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license key: cord- - vtgd s authors: Çetİn, ceren; kara, ateş title: global surveillance, travel, and trade during a pandemic date: - - journal: turk j med sci doi: . /sag- - sha: doc_id: cord_uid: vtgd s pandemics have had very important consequences in human history. lots of people lost their lives and countries have been intensively affected in terms of socioeconomic problems. unfortunately, avoidance of pandemics and limiting the spread are still currently not always possible. maybe the most important factor for this is the increasing frequency of traveling. increasing airline traveling rate also increases the rate of spread. global organizations like the world health organization and united nations are trying to play a supreme role over the countries. pandemics do not have borders; therefore, efforts should be given globally, definition of pandemic should be established as soon as possible, and protective measures should be shared with countries. if these are not done, severe health consequences and serious economic problems are inevitable. spanish flu led to the death of - million people worldwide (world population was approximately . billion during that time) and estimated case-fatality rate was determined as - % [ ] . the - pandemic, known as the asian flu, resulted in the death of - million people worldwide, and the - pandemic, referred to as the hong kong flu, caused the death of - million people worldwide. estimated case-fatality rate of the - influenza a (h n ) pandemic was established as . %. the age group the pandemic affected the most was children and young adults. it resulted in the death of - thousand people worldwide [ ] . last year around the end of , a novel coronavirus pneumonia case group was identified in the wuhan city of the province of hubei in china. rapidly spreading around the country, an epidemic arose and increasing number of cases started to be seen in other countries. in february , the world health organization defined covid- , which meant coronavirus disease. the virus causing covid- was referred to as severe acute respiratory syndrome coronavirus (sars-cov- ). an interim guideline was published by the world health organization and the centers for disease control and prevention (cdc) [ , ] . covid- was announced as a pandemic by the world health organization in march , and the pandemic is still continuing. during a pandemic, steps include controlling and surveilling the outbreak, finding the center, bringing the source under control, preventing human-to-human transmission, ensuring social distancing, and determining vaccination and treatment agents [ ] . in a model based on the flu pandemic analysis, it is assumed that one-third of the transmissions occurred in houses, one-third occurred in schools and workplaces, and the other one-third among the general public in the united states of america. thus, an important control strategy would target the closing of schools and workplaces [ ] . it should be seriously questioned whether hospitals would have the extreme capacity to treat a large number of patients or not. if not at sufficient capacity, necessary planning should be made by local supporters and public health officials in order to meet the deficit. other measures include planning healthcare services in alternative settings other than hospitals, taking necessary infection control measures, and drawing up clear guidelines in favor of public health for patient consent [ ] . it is necessary to form appropriate infrastructure and credible communication systems to coordinate public health intervention and plan and appoint leaders at national and local levels [ ] . the world health organization (who) recommends countries to make their own pandemic risk evaluations since incidence of human and animal cases in different countries in the world and the procedures to be done thereafter would differ. who updated its pandemic influenza risk management guideline in . this guideline can be used to inform and conform national and international pandemic preparations and interventions. countries should review and/or update their national flu preparation and intervention plans in order to reflect the approach taken in this guideline. moreover, roles and responsibilities of who regarding pandemic preparations were also stated in terms of supporting member countries in line with the crisis and risk management policies. this guideline does not intend to replace national plans that should be developed by each country. national pandemic influenza risk evaluation aims at determining the probability and outcomes of events affecting public health at a global, national, and local level. it constitutes the basis to act against and decrease the negative consequences of public health risks [ ] . it is attempted to make predictions with statistical models on when the agent would penetrate into the country or cities in the event of a pandemic [ ] . pandemic influenza phases reflect risk assessment of the global status concerning each and every influenza virus with a potential to be pandemic and to infect people. initially, these assessments are carried out when these types of viruses are defined and afterwards updated according to virologic, epidemiologic, and clinical data obtained. global phase represents the spread of the novel flu subtype to the world taking the disease it causes into consideration and separating it into interpandemic, alarm, pandemic, and transition phases. global phases are used by who to convey global status. pandemic phase is the period of global spreading. transitions between interpandemic, alarm, and pandemic phases can be rapid and gradual [ ] . as pandemic viruses emerge, countries and regions face different risks at different times. therefore, it is strongly recommended for countries to develop their own national risk assessments by considering information provided by who. hence, decisions for national risk management of any country are expected to be based on local risk assessments but also to be informed by global risk assessments [ ] . who should be able to follow the development process of the pandemic and guide countries with appropriate methods like strengthened surveillance and active monitorization. who should make suggestions in medical and nonmedical issues for this purpose. who should announce data independently and in a transparent manner; thus, who requires accurate and rapid data flow from every government in order to fulfill its obligation [ ] . united nations (un), on the other hand, is a much larger system. un aids in countries to adapt themselves to necessary arrangements strengthening technical capacities of the countries during pandemics through the peacekeeping commission, united nations development program, and united nations children's fund [ ] . risk assessment regarding pandemic influenza includes defining influenza viruses, reviewing significant virologic and clinical information on each and every influenza virus and classifying these as regards pandemic potency and probable outcomes. evaluation of exposure aims at identifying exposure to an upsetting flu virus, individual groups with a probability to become ill, and defining the sensitivity of these groups in terms of immunity and disease severity. this process contains epidemiologic and sensitivity factors such as travel history, incubation period, and estimated transmission potential. following risk and exposure assessments, these two assessments are finalized with a content evaluation. content evaluation is the assessment of the setting the event has taken or is taking place. content evaluation includes social, technological, scientific, economic, ethical, and political factors. exposure and content evaluations are made, and risk is characterized. risk characterization seeks to regulate the probability and impact of every risk. risk characterization uses these evaluations in order to assess if a specific flu virus has the potential to become pandemic and to what extent the society will be affected by such event and thus to judge the urgency and scope of risk management activities. risk assessment is a constant process during risk management continuity. for the evaluation of pandemic severity to be beneficial, it should be performed when public health decisions are required [ ]. to that end, surplus information should be provided in order to answer all critical questions regarding the pandemic that has emerged. questions on new cases and their progression and those regarding the type of diseases and complications encountered, which group of patients would be severely ill and die (i.e. age groups and groups at risk for severe outcomes), whether or not the virus is susceptible to antiviral agents, the number of people that would become ill, and the impact of the cases on the use of healthcare services and workforce should be answered. these questions will be of help in directing decisions on vaccination production and utilization strategy, antiviral use, mobilization of healthcare sources, school closings, and social distancing strategies. data responding to each critical question will be addressed in the context of three indicators. each of these indicators will contain information obtained from various data types including virologic, epidemiologic, and clinical data. data will be grouped so that they would be more accessible and comprehensible by the public and policymakers. national action plans have been charted according to six categories of principal components of emergency risk management for health. these include policy and resource management; planning and coordination; information and information management; health infrastructure and logistics, healthcare and related services; and community emergency situation risk management capacities [ ] . research projects, their budget and the number of researchers to work on these projects should also be carefully constructed. cooperation with the government for these plans is crucial [ ] . pandemics require globally compatible actions. pandemics are extremely destructive events that can cause serious social, economic, and political stress. preparation demands the approach of all communities in order to enable the world to respond quickly and effectively to decrease morbidity and mortality in the next pandemic. not only the healthcare sector, but also all other sectors, individuals, families, and communities play a role in lightening the effects of a pandemic. nonpharmaceutical interventions can be the only effective measure in many countries. during the onset of a pandemic, there would probably be no pandemic vaccination that would be effective against the novel virus. non-pharmaceutical interventions in the early stage of the pandemic should be implemented in order to slow down transmission and decrease its effect. these interventions include social distancing (staying home when ill), coughing etiquette (covering the mouth with a handkerchief while coughing or sneezing), and hygiene rules such as washing the hands and cleaning the surfaces and objects touched. extreme measures can be taken and implemented during severe pandemics including patients wearing masks (surgical masks), school closings, and diminishing contact between people. nonpharmaceutical interventions will help decrease the number of people exposed to and afterwards infected by the virus [ ] . since pandemics necessitate an approach for the whole community, individuals and communities should be cared about, listened to, and relieved of anxieties. people should be informed on how to protect themselves and stop the spreading of the virus [ ] . at the present time, airports, harbors and ports, road transportation and entry points to the country may have a critical role in the international transmission the diseases via persons, goods, and vehicles. therefore, countries should be ready to detect and respond to any healthcare event that would cause international concern by bringing healthcare-based restrictions in international travel and trade. thus, developing necessary public health capacities in entry points of the country will limit the spread of public health hazards ( ) . particularly frequent travelers may have a part in accelerating the international spread of the virus during the early period of the pandemic. hence, in the event of the onset of the pandemic being at a countryside where international travel is scarce, the transmission of the agent to frequent travelers will be much late and the spread of the pandemic will be much slower [ ] . international health regulations ( ) try to "limit public health measures preventing unnecessary intervention to international travel and trade". in order to reach this goal, who regularly makes recommendations on trade and travel measures regarding public health events. along with not interfering with measures related to specific trade and travel, international health regulations ( ) mandate countries to inform who on the justifications of the time of interventions and important measures taken by the administration of the countries. this is defined as the cause of a more than -h delay in the movement of international passengers, luggage, cargos, containers, vehicles, and items by the international health regulations ( ). apart from providing information to countries on these measures, who may demand from the implementing country to reevaluate these applications [ ] . world health organization continues to make recommendations against travel and trade restrictions for countries fighting with the covid- pandemic. travel measures interfering significantly with international traffic can only be justified at the onset of a pandemic since countries may be allowed to rapidly implement preliminary measures even for a few days. these kinds of restrictions should be based on meticulous risk assessment, be proportional to public health risk, not last long, and be reevaluated regularly as the event advances. travel ban to affected regions or rejection of entry of passengers traveling from affected regions is not effective in preventing case imports but may have important economic and social impact. temperature scan at entry and exit points is not an efficient way to stop international spread since infected people may be within the incubation period and not show early symptoms during the disease. for an adequate risk assessment and a follow of a probable case, the patients should be provided with disease-preventing messages, health statements should be collected upon entry, and contact information of the passengers should be obtained, which would be much more efficient [ ] . it is necessary to delay or prevent travel to affected regions for elderly patients and for those with underlying chronic diseases. personal hygiene, coughing etiquette, and putting an at least one-meter distance between yourself and those showing symptoms are important for all passengers. frequent hand hygiene after contact with particularly respiratory fluids is mandatory. hand hygiene includes washing the hand with soap and water or cleaning the hand with alcohol-based liquids. the mouth and nose of the person coughing or sneezing should be closed with a handkerchief or using the inner part of the elbow. touching the mouth and nose should be avoided [ ] . unless a person shows symptoms, s/he does not need to wear a medical mask since there is no evidence on any kind of masks protecting the noninfected person from the virus. besides, masks can be commonly worn in some cultures. it is important to follow the best practice on how to wear, remove, and dispose of the mask, and ensure hand hygiene if medical masks are to be worn [ ] . passengers returning from the affected regions should monitor the symptoms for days on their own and also follow the national protocols of the receiving countries. some countries may demand the returning passengers to be put in quarantine. should symptoms such as fever, cough, and difficulty in breathing manifest, it is recommended to the passengers to contact local healthcare providers preferably over the phone and inform them of their symptoms and travel history [ ] . it is suggested to follow the recommendations of who for designated passengers in entry points. the management of ill passengers in the context of present covid- disease pandemic in international airports, harbors, and motorway/road gates should include measures to be implemented according to the priorities and capacities of each country. in order to detect ill passengers and determine the symptoms of covid- disease and the possibility of virus exposure, interviewing with ill passengers, reporting cases with suspected covid- infection, isolation of those with suspected covid- infection and initial case management and referral are necessary [ ] . airport operators, aircraft/airplane operators, airline and airport crew, and ground personnel should be informed on how to recognize covid- signs and symptoms. crew and ground personnel should be informed on and frequently reminded of measures preventing the spread of covid- including social distancing, hand hygiene, respiratory etiquette, environmental cleaning, waste disposal, when and how to wear masks, and avoiding contact with people showing respiratory symptoms. medical face mask should be reserved for individuals with respiratory symptoms to prevent contamination with others. the personnel should be trained for hand hygiene and how to wear and remove protective equipment. personnel in close contact with symptomatic individuals should wear medical mask, eye protection (face shield or goggles), gloves, and gown [ ] . a number of factors should be taken into account to prevent the spread of covid- for countries that have decided to bring back citizens from affected regions. these include scanning right before flight, risk communication with the passengers and crew, infection control resources for the flight/journey, preparation of the crew for a possible infected passenger, entry scan upon arrival, and closemonitoring for days after arrival [ ] . countries should intensify surveillance for severe pneumonia and uncommon flu-like disease pandemics and attentively monitor the development of covid- pandemics by strengthening epidemiologic surveillance. countries should continue raising awareness in the public opinion, healthcare specialists and policy-makers through effective risk communication regarding covid- and should refrain from actions of stigmatization and discrimination. countries should share all related information on covid- for its timely evaluation and management as necessitated by the international health regulations ( ) [ ] . countries implementing additional health measures that significantly interfere with international traffic need to share related scientific data for the implementation of these measures and public health justification with who within the first h after the implementation. who will share this information with other countries. significant intervention generally means a more than -h delay in or rejection of international passengers, luggage, cargos, containers, vehicles, goods, and similar items [ ] . airline travel has the most important role in spreading pandemics. in a study considering airline network in the prediction of the spread of pandemics, rate and density of transmission have been detected with high accuracy [ ] . therefore, making predictions in early periods of pandemics using these modellings can be effective in rapidly taking necessary measures [ ] . if a country decides to quarantine arriving passengers who do not show symptoms, some factors should be taken into consideration. there is no universal guideline regarding the infrastructure of the quarantine facility; however, an area that will not increase the potential contamination and those put in quarantine should be recorded to be followed in the event of potential disease. accommodation and supplies, sufficient food and water to passengers, sleep arrangements and clothing, protection of luggage and other items, appropriate medical treatment, necessary communication devices should be adequately provided for in a language they can understand. medical mask is not required for those put in quarantine. if masks are used, the best practice should be followed. quarantine period, which lasts days (according to the currently known incubation period of the virus), can be extended due to delayed exposure [ ] . social and economic life continues during pandemics. a pandemic has the potential to affect all sectors. in the event of declaration of disaster as regards the severity of the pandemic, there is legislation oriented at covering fiscal charges. however, regulation should be made for pandemics that do not necessitate declaration of disaster in order to meet unexpected/unanticipated needs, and additional financial needs should be met. during a rapidly spreading pandemic, vital setbacks can be seen in the transfer of goods and services. the need for social support programs due to economic problems arising from the shutdown of businesses and interim unemployment [ ] . it is predicted that covid- pandemic will cost the world economy as much as an approximate trillion dollars, which is a much deeper and worse global crisis compared to that of - . institutions like the un are run with the aid of developed countries in particular. it is feared that a serious crisis will be felt in un resources as part of the effect of this pandemic and lead to weakness in the function of the un [ ] ). pandemic diseases may result in acute, short-term fiscal shocks and long-term damage in economic growth. early period public health efforts (such as monitoring contact, implementing quarantine, isolating contagious cases) in order to cover or limit pandemics require significant human resources and personnel cost. as a pandemic expands, new facilities may be needed to be constructed to manage additional contagious cases, and health system expenses will tremendously increase as a result of demand in medical supplies, personal protective equipment, and medicine. decreasing tax revenue may deepen the fiscal stress caused by increasing expenses in low-and middle-income countries that have weak tax systems and severe fiscal restrictions. this dynamic was seen in the western africa ebola pandemic in liberia in . as costs increased, economic activity slowed down, and quarantines and curfews decreased the government's capacity to collect revenues. during a mild-to-moderate pandemic, high income countries that are not affected can balance fiscal crises in low income countries by providing official recovery support including direct budget support. meanwhile, high income countries may be faced with the same fiscal stresses and be unwilling to provide help. during a severe pandemic, low-and middle-income countries may cut back in government expenses. negative economic crises are derived from workforce reduction due to disease and deaths and behavior change out of fear. fear manifests itself with many behavioral changes. the analysis of the economic effects of the western africa ebola pandemic has shown decrease in workforce, shutdown in businesses, delay in transportation, closing of land borders by some governments, restrictions implemented on citizens arriving from affected regions in entry to the country, cancellation of commercial flights, decrease in shipment and prevention in travel and trade. these effects decrease the participation of the pandemic to workforce and constrict local and regional trade. preventive behavior (such as prevention of travel, restaurant and public spaces and workplace discontinuity as prophylactics) also has economic outcomes. during a severe pandemic, all sectors of the economy (agriculture, manufacture, services) encounter shortages, rapid price elevation is basic necessities, deterioration that causes economic stress for the household, private firms, and governments. a severe pandemic may result in a significant and permanent economic damage [ ] . in order to take a pandemic under control, coordination should be established, flow of information should be regulated, necessary health interventions (case management algorithms, vector control) should be determined, health systems (hospitals, healthcare personnel, medicine) should be strengthened, the society should be informed, and the community should be included in pandemic surveillance and control. dictionary of epidemiology the classical definition of a pandemic is not elusive paleomicrobiology: past human infections health impacts of globalization: towards global governance world health organization. managing epidemic key facts about major deadly diseases novel coronavirus ( -ncov) technical guidance [online the risk of seasonal and pandemic influenza: prospects for control strategies for mitigating an influenza pandemic the health care response to pandemic influenza seasonal and pandemic influenza: recommendations for preparedness in the united states world health organization. pandemic influenza risk management. a who guide to inform & harmonize national & international pandemic preparedness and response global disease spread: statistics and estimation of arrival times to-concerns-in-serbia-over-its-actions-duringthe-influenza-a-h n - -pandemic/role-of-who-inpandemic-preparedness-and-response the covid- pandemic and research shutdown: staying safe and productive updated who recommendations for international traffic in relation to covid- outbreak frequent travelers and rate of spread of epidemics world health organization. management of ill travellers at points of entry -international airports, ports and ground crossings -in the context of the covid- outbreak management-of-ill-travellers-at-points-of-entryinternational-airports-seaports-and-ground-crossings-in-thecontext-of-covid-- -outbreak world health organization .operational considerations for managing covid- cases or outbreak in aviation interim guidance forecast and control of epidemics in a globalized world modelling the global spread of diseases: a review of current practice and capability key considerations for repatriation and quarantine of travellers in relation to the outbreak of novel coronavirus -ncov covid- pandemic and economic cost; impact on forcibly displaced people the international bank for reconstruction and development / the world bank key: cord- - ftnttm authors: gensheimer, k. f title: challenges and opportunities in pandemic influenza planning: lessons learned from recent infectious disease preparedness and response efforts date: - - journal: international congress series doi: . /j.ics. . . sha: doc_id: cord_uid: ftnttm abstract the impact of the next pandemic influenza is likely to be far greater, by orders of magnitude, than most bioterrorism (bt) scenarios. a written pandemic emergency plan and establishment of emergency management teams are critical to mounting a coordinated and effective response to what will be a catastrophic event. members of these teams should include public health, medical, emergency response and public safety officials, organized at each local, state and federal level. the tragic events of september , and the subsequent anthrax attacks have substantially increased funding and support for bioterrorism planning in the united states. thus, public health officials have an unprecedented opportunity to strengthen current systems' planning efforts by promoting dual use bioterrorism/pandemic influenza plans. combining lessons learned from the terrorist incidents, recent preevent smallpox vaccine programs and the history of past influenza pandemics, more effective strategies can be developed. for example, enhanced influenza surveillance systems can provide data that will not only provide early identification of a novel influenza strain, but will provide more timely recognition of other outbreaks of infectious diseases, including public health threats that may initially present as an influenza-like illness (ili). in recent years, we have witnessed emerging and reemerging infectious disease threats that have presented us with challenges similar to those posed by an influenza pandemic. such events highlight the need for advance planning to ensure an optimal response to a health emergency that is certain to be unpredictable, complex, rapidly evolving and accompanied by considerable public alarm. while advance warning for a terrorist attack is unlikely, the warning already exists for a possible new influenza strain, as evidenced by the recent cases of h n in hong kong and the rapid global spread of cases of severe acute respiratory syndrome. influenza is transmitted readily from person to person, and because a novel influenza virus, by definition, is one to which the general population has little to no immunity, an influenza virus with pandemic potential has the potential to cause substantial morbidity, mortality, social disruption, and widespread panic. crosby's [ ] book, ''america's forgotten pandemic: influenza '' notes that more americans died of pandemic influenza than of war-related causalities throughout the entire history of this nation. despite the extent of morbidity experienced, little attention was focused on this catastrophic heath event. in contrast, the tragic events of september , coupled with the use of bacillus anthracis as a bioterrorist weapon of mass destruction, received considerable attention from the media, the public and the political leadership of this country. one of the greatest revelations in the aftermath of these unprecedented events was the realization that public health is a bona fide first responder. in the current era of concern for bioterrorism (bt) disaster-type preparedness, the public health community needs to acknowledge the leadership position it has achieved through these recent events and to accept yet another challenge of thinking broadly and creatively to address the many needs posed by a catastrophic infectious disease disasterbe it an influenza pandemic, a bioterrorism event or an emerging/reemerging infectious disease threat that is yet to be identified. planning for these events can no longer be postponed as advance planning and building of public health infrastructure can make a significant difference in our response. national efforts to prepare for the next influenza pandemic require support and collaboration from multiple partners at the state, local and federal level. establishing relationships with the medical community, law enforcement and public health agencies are not only critical in responding to a potential catastrophic event, but will enhance ongoing everyday work. the recent anthrax events demonstrated that public health's unfamiliarity with the emergency response system's incident command structure impeded investigative efforts. cross-department planning will facilitate a more effective response to pandemic influenza, strengthen ties between public health and emergency response sectors and complement other planning efforts for not only pandemic influenza but for other emergencies including acts of terrorism. a written pandemic emergency plan and an established emergency management team, which includes public health, medical, emergency response and public safety officials, are needed to provide effective leadership, coordination and an effective response to the next influenza pandemic. the planning and public health infrastructure needed to effectively address a bioterrorist event and an influenza pandemic overlap considerably. one such area of overlap is surveillance. global and domestic laboratory and disease surveillance must be strengthened to increase the likelihood of early detection and tracking of pandemic influenza or a bioterrorist event. improvements in state public health laboratory capacity through support of the laboratory response network (lrn) has enhanced rapid testing for influenza. because many potential bioterrorist agents initially cause symptoms that resemble an influenza-like illness (ili), it is critical for every state to have rule-out influenza testing capabilities available on a year-round basis. timely reporting of outbreaks and surveillance for influenza-like illness (ili) are directly relevant to tracking the progression and intensity of influenza activity and may provide an early indication of a bioterrorist event. continued support for the early aberration reporting system (e-ars) and other innovative surveillance strategies will benefit the public during seasonal influenza epidemics, an influenza pandmeic, and any other catastrophic disease event. another critical component of any catastrophic infectious disease plan and response is communication. a key lesson learned from the anthrax attacks was that the public demands up-to-date information on an ongoing basis throughout the emergency. factual information presented by trusted public health officials can assist in minimizing fear and hysteria. most health crises are similar to the recent anthrax attacks, where only a few cases are ultimately diagnosed, but the bulk of the populace seeks information on a rapidly unfolding scenario. demand for factual information will only be heightened for a highly contagious disease entity such as pandemic influenza. data generated as a result of a robust surveillance system can assist public health efforts in minimizing hysteria and preventing the dissemination of misinformation regarding the evolving pandemic: has the novel virus arrived; geographical areas of the country most severely affected; whether disease activity is increasing or decreasing and groups most severely affected. despite the many similarities between pandemic influenza and planning for other catastrophic infectious disease events, including an act of bioterrorism, critical differences do exist. unlike the anthrax events of where there was no forewarning, surveillance should provide days to months of warning for a pandemic, while the pandemic itself will last for several months or years. there will be no ''unaffected'' areas, as the pandemic influenza virus will be present virtually simultaneously in all parts of the country. mutual aid from either the federal government or other regions of the country will be unlikely, as all public health, medical and emergency resources will be dedicated to the disaster at hand locally. support from the federal government will be limited in such a scenario; despite the fact, such assistance usually comes during other states of emergency. resource deficiencies will exist for inpatient/outpatient medical services, biologic products, and key personnel. absenteeism among essential first-line medical and emergency workers will impact services rendered, as no one will be immune to infections from the novel pandemic influenza virus. vaccine will be the primary prevention tool, assuming that vaccine will be able to be developed in a timeframe that will be useful. promoting adult immunization programs, including increasing the use of influenza and pneumococcal vaccine during interpandemic years will also strengthen the public health response. the tragic events of september and the subsequent anthrax attacks and other recent threats posed by severe acute respiratory syndrome and monkey pox have created considerable demand on the medical and public health communities nationwide. as a result, unprecedented resources for enhancing our public health preparedness and response infrastructure at all levels of government have been recently provided to all states by congressional appropriations in the form of bioterrorism cooperative agreements administered by the centers for disease control and prevention (cdc). the request for proposals explicitly note that planning moneys may be used ''. . . to upgrade state and local public health jurisdictions preparedness for and response to bioterrorism, other outbreaks of infectious disease, and other public health threats and emergencies. . .'' [ ] . although these funds will be critical for strengthening this country's preparedness and response to bioterrorism, there exists substantial overlap between the public health infrastructure needed to address bioterrorism-related events and other potential public health threats including pandemic influenza. hence, the current climate presents an opportune time to engage in pandemic preparedness planning. taking advantage of the current funding opportunities will not only optimize our response to such a catastrophe, but will help to limit the total burden of disease in terms of morbidity and mortality, economic loss and social disruption caused by an influenza pandemic. by reflecting upon the lessons learned from the influenza pandemic and recent emerging infectious disease catastrophic events, the public health and medical community can work together to develop an effective preparedness and response plan to strengthen our national readiness to respond to an influenza pandemic as well as to strengthen the health system on which the plan depends. the state and local guidelines developed by the state and federal working group [ ] address the various essential components of an infectious disease catastrophic response: surveillance, communication, emergency preparedness, recommendations for distribution of limited biological products, and infection control/medical management. many lessons were learned through the events of september and the aftermath of the attacks using anthrax through the postal service. public health must assume a leadership position in planning effectively and utilizing newly generated resources to optimally prepare for the next public health catastrophe. like the emerging diseases and recurring disease that have occurred over the past several years, we need to think of bioterrorism and the threat posed by influenza pandemic as an emerging and recurring threat, which will probably continue into the foreseeable future. limiting our planning efforts narrowly focused on bioterrorism will be a lost opportunity. in the highly interconnected and readily traversed 'global village' of our time, one nations' problem soon becomes every nation's problem. . . [ ] america's forgotten pandemic: the influenza of notice of cooperative agreement award: guidance for fiscal year supplemental funds for public health preparedness and response for bio-terrorism (announcement number -emergency supplemental) pandemic influenza: a planning guide for state and local officials ( . ) national academy of sciences, institute of medicine, microbial threats to health: emergence, detection and response we wish to acknowledge the members of the ad hoc influenza pandemic conference planning and steering committee for their continuing dedication and contributions to pandemic planning: lynnette brammer, ron burger, zygmunt dembek, kristine ehresmann, john iskander, deva joseph, donna lazorik, ann moen, mack sewell and gregory wallace. key: cord- - j tqmd authors: an, ying; yang, yuan; wang, aiping; li, yue; zhang, qinge; cheung, teris; ungvari, gabor s.; qin, ming-zhao; an, feng-rong; xiang, yu-tao title: prevalence of depression and its impact on quality of life among frontline nurses in emergency departments during the covid- outbreak date: - - journal: j affect disord doi: . /j.jad. . . sha: doc_id: cord_uid: j tqmd background: frontline medical staff exposed to the novel coronavirus disease (covid- ) could be psychologically and mentally exhausted. this study examined the prevalence of depressive symptoms (depression hereafter) and its correlates and the association between depression and quality of life (qol) in emergency department (ed) nurses during the covid- pandemic in china. methods: this national, cross-sectional online survey was conducted between march to march , in china. depression and qol were measured using the -item patient health questionnaire, and the world health organization quality of life questionnaire-brief version, respectively. results: the overall prevalence of depression in , ed nurses was . % ( % ci= . %- . %). multiple logistic regression analysis revealed that working in tertiary hospitals (or= . , p= . ), direct patient care of covid- patients (or= . , p= . ), and currently smoking (or= . , p< . ) were significantly associated with depression. after controlling for covariates, nurses with depression had an overall lower quality of life compared to those without (f(( , ))= . , p< . ). conclusion: depression is common among ed nurses during the covid- pandemic. considering the negative impact of depression on quality of patient care and nurses’ quality of life, a heightened awareness and early treatment of depression for frontline ed nurses should be provided. frontline emergency department (ed) nurses exposed to the novel coronavirus disease could be psychologically and mentally drained, but the prevalence of depression in this population is still unknown. the overall prevalence of depression among , ed nurses was . % ( % ci= . %- . %).  a heightened awareness and timely treatment of depression for frontline ed nurses should be provided in a timely fashion. in late , the novel coronavirus disease was first found in china. on the th january, , the world health organization (who) declared covid- a public health emergency of international concern (world health organization, ). in order to reduce the rapid transmission of the covid- and to take care of confirmed and suspected patients, additional services, such as fever clinics and isolation infectious units, have been set up in emergency departments (ed) in many hospitals (national health commission, ) . ed nurses often face enormous psychological pressure due to overwhelming workload, long hours, shirt duties and working in a fast-paced and high-risk environment (healy and tyrrell, ; hooper et al., ) . nurses working in a such physically and emotionally challenging situation frequently experience fatigue, burnout, mental exhaustion, and emotional detachment (boyle, ) . during the covid- pandemic, frontline clinicians including nurses, especially those who have close contacts with infected patients, regularly experienced anxiety and depressive symptoms (depression hereafter), emotional breakdown and sleep disturbances due to the limited clinical knowledge of the new virus and the insufficient provision of protective gears and other medical supplies , which may lead to poor morale at work, absenteeism, apathy, and poor work performance leading to patient dissatisfaction (portnoy, ; vahey et al., ) . since the outbreak of the covid- , some studies have examined the epidemiology of psychiatric problems in frontline clinicians. for instance, a recent cross-sectional study reported that the prevalence of depressive, anxiety, insomnia and non-specific distress symptoms was . %, . %, . %, and . %, respectively in frontline clinicians including nurses (lai et al., (li, ; xi, ) . wechat is a communication program employed by the chinese nursing association for continuing education for all its members. in order to reduce disease transmission during the covid- outbreak, face-to-face interview could not be adopted. to be eligible, participants should be: ) adults aged years or above; ) frontline nurses working in ed during the covid- outbreak; ) able to understand chinese and provide written informed consent. the study protocol was approved by the ethics committee of the university of macau, china. basic demographic information including gender, age, marital status, educational background, work experience, shift duty, living circumstances, rank (junior/senior), type of hospital (primary/tertiary), work place (inpatient/outpatient), current smoking status, and work experience during the sars outbreak. nurses were also asked three additional standardized questions whether ) they were directly engaged in clinical services for patients with covid- ; ) their family, friends or colleagues were infected with the covid- ; and ) there were or more confirmed covid- cases in the province where they lived/worked. a -item self-report instrument, which is widely used in clinical settings. each item is scored from to , with the total score of or more indicating "depression" (kroenke et al., ) . a total score of - indicates "mild depression"; - "moderate depression", - "moderate-to-severe depression", and ≥ "severe depression" (kroenke et al., ) . the chinese version of phq- demonstrated satisfactory psychometric properties (cronbach"s alpha= . ) (chen, ; leung et al., ) . nurses" qol was assessed with the sum of the first two items on overall quality of life derived from the world health organization quality of life questionnaire-brief version (whoqol-bref) (harper et al., ) . higher total scores indicate higher qol (skevington and tucker, ) . the chinese version of this scale has satisfactory psychometric properties (fang, ). all the analyses were performed with the spss, version . . the normal distribution of continuous variables was examined by the kolmogorov-smirnov test. demographic variables between the "depression" and no-depression" groups were compared using the chi-square tests, two samples independent sample t-tests, or mann-whitney u tests, as appropriate. to examine the independent demographic and clinical correlates of depression, multiple logistic regression analyses with the "enter" method (i.e., entering all independent variables in the model simultaneously) was conducted. depression was entered as the dependent variable, while all variables with a p value of < . in the univariate analyses were the independent variables. analysis of covariance (ancova) was performed to compare the qol between the two groups after controlling for variables with significant group difference in univariate analyses. level of significance was set as p< . for all tests ( -sided). a total of , frontline ed nurses met the study criteria and completed the survey. the demographic characteristics of the sample are shown in to the best of our knowledge, this was the first study that comprehensively examined the epidemiology and correlates of depression among ed nurses during the covid- pandemic. close to half ( . %; % ci: . %- . %) of the ed nurses suffered from depression, which is similar to the findings reported by lai et al. (lai et al., ) in chinese frontline clinicians ( . %). another chinese study using the same assessment tool found that . % of frontline clinicians reported depression during the outbreak of covid- (zheng, ) . using the phq (cut-off of ), cui ( ) found that the prevalence of depression in chinese ed nurses was . %. ed is an ever-changing, highly regulated workplace, dealing with patients in critical conditions (lu et al., ) . ed nurses are responsible for a wide spectrum of clinical tasks, some of which may be life-threatening clinical situations and require immediate attention (lu et al., ) . the high work pressure, low level of control and autonomy and perceived powerlessness as revealed in a free-flowing interview of ed nurses could account for the higher risk of depression and related health problems (severinsson, ) . besides, heavy workload, shift work, resuscitation and death were proven risk factors of psychological distress, particularly depression among ed nurses (lim et al., ; morrison and joy, ; winwood et al., ) . during the covid- outbreak, ed nurses were more likely to experience excessive workload, fatigue, helplessness, and feared high risk of infection. these factors could also be associated with the reported high prevalence of depression in ed nurses. nurses working in tertiary hospitals and those who looked after covid- patients were more likely to suffer from depression. during the covid- outbreak in china, provinces, municipalities, and autonomous regions covering over a population of . billion initiated first-level responses to such a major public health emergency . most tertiary hospitals in each province were designated as first-line emergency isolation hospitals/units to provide clinical services for suspected and confirmed cases of covid- (national health commission, ). compared to those in primary/community clinical settings, ed nurses in tertiary hospitals required to have more frequent close contacts with infected patients as they were responsible for triage and initial care. the nature of work assigned to ed nurses led to higher level of stress and fear, which subsequently resulted in higher rate of depression. working in frontline clinical settings is an independent risk factor for poor mental health (lai et al., ) . during the sars outbreak in china, almost % of the frontline clinicians in high-risk clinical settings reported psychological symptoms (chua et al., ) . consistent with previous findings (lai et al., ) , frontline nurses who engaged in clinical care of covid- patients were at higher risk of depression in the current study. ed nurses were required to work longer hours than ever due to the huge number of patients during the covid- outbreak. after long working hours, all ed nurses had days of mandatory quarantine, which could further exacerbate their anxiety and guilt because of the social stigma conferred on to their families. furthermore, ed nurses also experienced fear of getting infected and spreading the virus to their families and friends. all these factors could substantially increase the risk of depression. similar to previous findings (li et al., ; , current smoking was significantly associated with higher risk depression in this study. ed nurses had high-pressure jobs in clinical settings, and some of them may find smoking immediately relaxing despite of its long-term harmful effects. according to the distress/protection model of qol (voruganti et al., ) , qol is determined by the interaction between protective (e.g., good social support and high socioeconomic status) and distressing factors (e.g., physical diseases and mental disorders). considering the negative impact of depression on the quality of clinical practice and its symptom profile including hopelessness, helplessness, insomnia, cognitive impairment, and somatic complaints (ivbijaro et al., ; singleton, ) , it is reasonable to assume that depressed nurses are far more likely to have lower qol than nurses without depression. in this study depressed nurses reported lower qol than those without, which echoed previous findings (malhi and mann, ; sjoberg et al., ) . the strengths of this study included the large sample size and the use of standardized instruments on depression and quality of life. however, there were several limitations. first, due to logistical reasons, some variables associated with depression, such as social support, collegial relationship, health status and pre-existing psychiatric disorders, were not examined. second, because of the cross-sectional study design, the causal relationship between depression and other variables could not be examined. third, more than % of the participants were female nurses, which may have biased the findings to an uncertain extent. in conclusion, depression is common among ed nurses during the covid- outbreak. considering the detrimental impact of depression on quality of life and quality of care (ng et al., ) , health authorities should organize regular screening targeting depression, and develop preventive measures to alleviate the risk of depression by providing a timely provision of financial support, online psychological counselling service, and on-site psychological guidance as well as offering psychiatric treatment for vulnerable nurses directly engaged in the treatment and care of covid- patients. author disclosure countering compassion fatigue: a requisite nursing agenda diagnostic test of screening depressive disorder in general hospital with the patient health questionnaire (in chinese) psychological effects of the sars outbreak in hong kong on high-risk health care workers reliability and validity for chinese version of who quality of life scale development of the world health organization whoqol-bref quality of life assessment stress in emergency departments: experiences of nurses and doctors compassion satisfaction, burnout, and compassion fatigue among emergency nurses compared with nurses in other selected 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and patients (in chinese) tribute to health workers in china: a group of respectable population during the outbreak of the covid- timely mental health care for the novel coronavirus outbreak is urgently needed investigation on the stress level and depression of medical staff during the new coronavirus pneumonia outbreak (in chinese) none. the authors have no conflicts of interest to declare. key: cord- -zjw fbfd authors: bhaskar, sonu; bradley, sian; chattu, vijay kumar; adisesh, anil; nurtazina, alma; kyrykbayeva, saltanat; sakhamuri, sateesh; moguilner, sebastian; pandya, shawna; schroeder, starr; banach, maciej; ray, daniel title: telemedicine as the new outpatient clinic gone digital: position paper from the pandemic health system resilience program (reprogram) international consortium (part ) date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: zjw fbfd technology has acted as a great enabler of patient continuity through remote consultation, ongoing monitoring, and patient education using telephone and videoconferencing in the coronavirus disease (covid- ) era. the devastating impact of covid- is bound to prevail beyond its current reign. the vulnerable sections of our community, including the elderly, those from lower socioeconomic backgrounds, those with multiple comorbidities, and immunocompromised patients, endure a relatively higher burden of a pandemic such as covid- . the rapid adoption of different technologies across countries, driven by the need to provide continued medical care in the era of social distancing, has catalyzed the penetration of telemedicine. limiting the exposure of patients, healthcare workers, and systems is critical in controlling the viral spread. telemedicine offers an opportunity to improve health systems delivery, access, and efficiency. this article critically examines the current telemedicine landscape and challenges in its adoption, toward remote/tele-delivery of care, across various medical specialties. the current consortium provides a roadmap and/or framework, along with recommendations, for telemedicine uptake and implementation in clinical practice during and beyond covid- . coronavirus disease has challenged the status quo of how we approach, deliver, and receive modern medicine ( ) ( ) ( ) ( ) . according to the american telemedicine association, telemedicine is defined as "the remote delivery of healthcare services and clinical information using telecommunications technology" ( ) . it allows for patient care while minimizing the need for physical interaction, thus reducing infection transmission and healthcare facility burden. it can be utilized for ongoing management of chronic conditions, medication compliance, physician-topatient consultation, and other remote services ( , ) . this can be leveraged to benefit broader populations through telehealth platforms and assisted technologies such as the internet of things (iot). telemedicine and digital technologies demonstrate exceptional potential in improving access and delivery in remote settings. there is also an opportunity to exploit the power of artificial intelligence (ai) algorithms to design a better pandemic preparedness and response plan ( ) . health systems have had to adapt to address emerging needs quickly, and many medical subspecialties have transitioned from in-person outpatient care to remote tele-or e-health. broadly, telehealth technologies can be deployed for targeted purposes relevant to a pandemic ( ) . remote assessment of patients could be undertaken, circumventing visits to outpatient clinics or primary care providers. patient continuity for those with chronic diseases is essential during a pandemic ( , ) . such patients are also at high risk of infection and poor outcomes, including mortality, among covid- -positive patients ( ) . notably, telemedicine also limits infection exposure to healthcare staff, can provide rapid access to subspecialists who are not immediately available in person, and allows for multidisciplinary team discussions. this is crucial in pandemic settings, as the safety of healthcare professionals is essential to ensure the sustainability of health systems to cater to emergent cases and maintain ongoing care. patients with flu-like symptoms can be triaged, and telemonitoring using video surveillance could be considered for patients who are homebound such as the elderly or frail. telemedicine can increase access for certain populations who are challenged during limited healthcare facility visitation, stay-home orders, and quarantine, such as single parents, immunocompromised patients, and patients who rely on the assistance of others for transportation. monitoring of patients along with remote delivery of home-based exercise, physiotherapy, psychological counseling, social work consultations, and speech and language interventions could be undertaken through telemedicine. our previous work analyzed the status and deployment of telemedicine during covid- across the geographical divide (bhaskar et al., under review) . in this article, we analyze the uptake of telemedicine across various medical subspecialties and organizational settings with a focus on the current covid- pandemic and propose an operational roadmap for further integration of telemedicine or tele-technologies across health organizations. as hospital systems become strained by the surge of covid- patients, methods to improve the efficiency of emergency departments (eds) are required, while maintaining standards of patient care. telemedicine supplies a potential avenue for triage of critical cases. remote and ambulatory monitoring of patients can allow for remote triage and assessment of emergencies such as acute myocardial infarction (mi), allowing patients to bypass the ed ( ) . automated forward triage systems that use algorithms to categorize patients into risk groups could also be utilized, as ed physicians experience considerable time pressure. current examples include the multi sources healthcare architecture (mhsa) algorithm and the electronic modified early warning scorecard ( ) . telemedicine has also been used to triage, expedite, and streamline the local covid- screening process, thereby reducing the strain on healthcare facilities and practitioner exposure. the new york presbyterian hospital, a world leader in digital health innovation, has demonstrated an effective method to reduce the burden of milder presentations ( ) . they established an ed-based telehealth express care service, in which after presentation and triage at the ed, patients with milder cases are taken into a private room for a teleconsultation with a physician. prescriptions and patient instructions are then printed to the room, and the patient is discharged. this dramatically reduces ed waiting times and allows the hospital to deal with everincreasing ed presentation numbers ( ) . as patients become anxious about ed infection risk, systems such as these are required, and patients need to be able to effortlessly contact eds to query whether their symptoms require a presentation. cardiology is one of the first specialties in which comprehensive telemedicine systems have been implemented. monitoring of heart rhythm in patients with implanted or real-time wearable devices has allowed ecg with holter monitoring, echocardiography records, and virtual auscultation. an emerging body of evidence suggesting cardiac involvement in covid- patients has concerned cardiologists ( , ) . this includes cardiovascular complications such as cardiac injury, heart failure, myocarditis, pericarditis, vasculitis, and arrhythmias ( ) ( ) ( ) . patients with pre-existing cardiovascular conditions who contract covid- also experience inordinately poor outcomes, including a -to -fold rise in mortality ( ) . due to the covid- pandemic, the american college of cardiology urgently updated its guidance on "telehealth: rapid implementation for your cardiology clinic, " in which it encouraged remote monitoring and virtual visits of patients with cardiac problems ( ) . the development of prognostic models based on the recently launched new european register capacity-covid will help to understand the role of underlying cardiovascular disease (cvd) in patients with covid- ( ) . virtual options can significantly increase efficiency compared to in-person doctor appointments ( ) . notably, non-invasive telemonitoring in patients with heart failure reduces allcause mortality and number of hospitalizations, as well as improves the quality of life ( ) . in february , the italian society of cardiology published data on the implementation of telemedicine in cvd patients and reported crucial involvement of telemedicine in the prehospital triage for st-elevated myocardial infarction (stemi) cases and remote monitoring by primary care physicians ( ) . an american heart association (aha) statement emphasized the role of telemedicine in pediatric cardiology through advanced video technologies like tele-echocardiography, fetal echocardiography in prenatal diagnosis, screening for congenital heart diseases, and confirmatory echo tests, external rhythm monitoring, catheterization laboratory, and personal tele-electrophysiology ( ) . due to their comorbidity risk, efforts to prevent covid- infection in cvd patients should be undertaken seriously by reducing hospital admission and outpatient visits ( ) . treatment adherence is one of the significant issues in the long-term management of cvds ( ) . the utilization of mobile phones through mobile health (mhealth) can be one of the reliable potential solutions in this area through measures such as electronic pillboxes and text reminders ( ) . the unique advantage of portable devices and smartphones is the ability to reach most patients and caregivers. the widespread use of mobile technologies makes medical support more effective, faster, safer, and less expensive in both outpatient and inpatient settings ( ) . mhealth can play an increasingly important role in cardiac care, extensively applied in triage, interventions, management, patient education, and rehabilitation. telehealth solutions are critical now, as we aim to minimize patients at high and very high cardiovascular risk being hospitalized and provide ongoing support to cvd patients during the covid- pandemic. in poland, some other systems have been tested in heart failure patients ( , ) , including e-oximeter, allowing for monitoring of heart rhythm and blood saturation, which might help to decide whether those quarantined should be hospitalized during covid- . telemedicine allows for prompt assessment of potential emergent neurological cases and can aid those with hospital access issues and those requiring fast acute assessment ( , ) . acute stroke outcomes are vastly impacted by the speed at which treatment is given, whether it be through tissue plasminogen activator (tpa), endovascular clot retrieval (evt), or antihypertensives. during times of physician shortages, as doctors become re-purposed for covid- purposes, rapid approaches to acute stroke management are needed ( ) . reperfusion treatment viability through computed tomography (ct) can be assessed remotely, allowing reperfusion treatment using tpa and/or evt to be efficiently undertaken. furthermore, telemedicine can be utilized to determine which patients require an urgent transfer from non-evt-capable hospitals to evtcapable hospitals ( ) . a program developed in germany known as transit-stroke, in which rural hospitals established a telemedicine network, saw an improvement in patient outcomes as neurological assessment was made faster, treatments were issued within the required timeframe, and h neurologist access was enabled ( ) . similarly, successful programs have been undertaken worldwide, such as telestroke programs in hawaii and south california ( ) . there is also evidence to suggest that patients who receive acute stroke assessment through telemedicine do not perceive decreased physician empathy compared to those who receive physical consultation ( ) . this somewhat relieves concerns about impaired patientphysician connection through telemedicine. while telemedicine decreases the time it takes to analyze head cts, more work is needed to ensure that this benefit applies equally across different telestroke programs ( ). mobile stroke units (msus) go beyond this to provide ct scanners and stroke personnel within an ambulance vehicle. such programs exist in locations such as melbourne (australia), various states in the us, and hamburg and berlin (germany), among others ( ). msus improve acute ischemic stroke outcomes by reducing the time to reperfusion; however, further development is needed in the treatment of hemorrhagic stroke. telemedicine could also allow ct assessment of mild traumatic brain injuries (such as concussions). this can help to determine if the patient requires transfer to a major hospital or can be treated locally and will also allow for post-concussion checkups ( ) . vulnerable patients who require respiratory management and/or critical care are at increased covid- risk due to their impaired state and require effective management with the aid of technology ( ) . in , the society of critical care medicine (sccm) tele-icu committee in the united states published an update on developments in telehealth critical care (tcc) ( ) . they described three emerging trends in tcc: hub-andspoke structure in which a central hub provides remote technical support, administrative support, and integration to a network of hospitals; decentralized structures in which consultations and patient reviews will be made on a case-by-case and request basis between two sites; and a hybrid structure in which a centralized structure exists but direct contact between spokes can be made for, e.g., specialist consultations. barriers to tcc included cost and reimbursement issues, lack of responsibility for individual hospitals, and legislative issues ( ) . a systematic review and meta-analysis of telemedicine in the us intensive care unit (icu) setting demonstrated decreased mortality and length of hospital stay with telemedicine incorporation ( ) . however, a statistical difference between an active model or high-intensity passive model, in which continuous patient telemonitoring is conducted, and a lowintensity passive model, in which only teleconsultation with an intensivist is conducted, was not ascertained and is an area for further research ( ) . patients with respiratory issues are at higher risk of covid- severe infections due to issues such as ventilator reliance and decreased cough function ( ) . this includes patients with chronic respiratory conditions such as chronic obstructive pulmonary disease (copd), bronchial asthma, interstitial lung diseases, as well as chronic neurological conditions such as neuromuscular diseases ( , ) . telemedicine aids respiratory patients through data collection, such as monitoring of vitals and ventilator status, and by transmitting these data for constant monitoring. in the case of under-resourced or under-developed critical care units in low and middle-income countries (lmics) (bhaskar et al., under review) , frequent international tele-education can serve to upskill doctors and spread critical care knowledge, such as ventilator management ( ) . patients with non-acute diseases require ongoing support and cannot be neglected during covid- times ( , , , ) . studies have shown that telemedicine can lead to similar outcomes as face-to-face delivery of care in the management of patients with heart failure, hypertension, and diabetes ( , ) . ongoing monitoring of these patients is required to prevent acute manifestations, hospitalization, or disease progression ( , ) . the differences within medical subspecialties and individual patients need to be considered, rather than broadly implementing uniform telemedicine approaches across all departments. for example, infectious disease cases can be complicated and require careful consideration of patient history and investigation findings. in these cases, asynchronous consultations, in which the physician reviews data before supplying patient recommendations, will be helpful ( ) . in other fields such as neurology, cardiology, and endocrinology, realtime, interactive consultations might be more applicable ( , ) . patients with neuromuscular issues are particularly at risk due to covid- ( ). patients with motor neuron disease (mnd)/amyotrophic lateral sclerosis (als) are among those who experience considerable disability and will require multidisciplinary telehealth ( ). types of telehealth include teleadvice, teleconsultation, tele-prescription, videoconferencing, home-based self-monitoring, and remote non-invasiveventilation (niv) monitoring. videoconferencing involves consultation with a health professional, home-based selfmonitoring involves taking one's own measurements and submitting them to a physician, and remote niv monitoring involves remote monitoring of the patient's niv data ( ) . the use of telehealth with als patients has been shown to be associated with positive benefits such as reasonable adoption rates, personalized data, and efficient consultations ( ) . other movement disorders such as parkinson's disease (pd) also require ongoing multidisciplinary care ( ) . established programs such as the ontario telemedicine network, the parkinsonnet infrastructure in the netherlands, and that of kaiser permanente in the us all display the ability to integrate telehealth into pd patient care ( ) . areas for growth include the reimbursement of nursing homes that utilize telemedicine, acceptance by patients and physicians, and reimbursement of at-home telemedicine programs ( ) . furthermore, global partnerships can increase international telehealth integration. for example, the international parkinson and movement disorders society africa section, established in the usa, launched a -year program to deliver specialist care to disadvantaged areas in africa using whatsapp tm . diagnosis of pd could also be aided by telehealth, with the unified parkinson's disease rating scale (updrs) and montreal cognitive assessment (moca) for pd both being able to be performed remotely ( ) . such tele-tools have also been recently proposed in the times of covid- for familial hypercholesterolemia patients, who require continuous monitoring of their health due to lifelong high levels of cholesterol and increased cvd risk ( ) . in migraine and headache patients, telemedicine could be used to assess new headache profiles for possible covid- symptomology or standard outpatient consultations ( , ) . cancer patients are another group at risk of covid- infection due to their immunosuppressed states, which could have fatal outcomes subsequent to infection ( ) ( ) ( ) ( ) ( ) . oncologists would use telemedicine for ongoing monitoring and compliance with cancer patients ( , ). this could be useful in monitoring adverse reactions to ongoing chemo-or radiotherapy, as well as to identify patients who might be at high risk of emergent medical attention, such as those at risk of venous thromboembolism. cancer patients could also be offered multidisciplinary care, including psychological interventions, physiotherapy, and specialized interventions such as mindfulness training, to improve the overall quality of life ( ). overall, telemedicine offers opportunities for cancer patients to access specialist care in the comfort of their homes. approaches to the use of telemedicine and mobile technologies in increasing access to novel drugs or interventions through clinical trials should be expeditiously pursued. telemedicine could also be used in palliative care and end-of-life planning involving patients' carers, family, and multidisciplinary care team ( ) . teledermatology is another promising perspective in the diagnosis and monitoring of skin lesions, including cancer ( ) . non-acute ophthalmological telemedicine has been implemented for retinal scans relating to diabetic retinopathy, retinopathy of prematurity, and other non-acute retinal monitoring ( ) . fundus scanning and optical coherence tomography imaging are being sent to remote trained healthcare practitioners (hcps) for evaluation and additionally are being evaluated by ai analysis using deep learning. these non-acute services are also being utilized locally by emergency and urgent care services to a certain extent ( ) . chronic patients must adhere to medications during this time and should not stop treatment regimens without consulting their physician ( , ) . patients taking immunosuppressants, steroids, or pain medications may be concerned about their covid- risk, and contact with their physicians needs to be ensured. adherence to medications can be monitored through mhealth and telehealth means ( ) . such examples include digital adherence technologies (dats) or electronic directly observed therapy (edot) for patients with tuberculosis ( ) . measures include ingestible sensors, video observation, digital pillboxes, and smartphone applications and have been trialed in china, india, belarus, and the us ( , ). the european respiratory society (ers) task force has described the implementation of remote home mechanical ventilation and physical therapy for patients with chronic respiratory disorders ( ) . the emphasis is on promoting common standards of clinical criteria as well as analyzing the cost/benefit ratio and evaluating reimbursing rules to implement in different countries ( ) . tele diagnosis uses patient data to aid remote diagnosis and can be utilized to identify those with bulbar and respiratory weakness. telemedicine strategies such as electronic inhalers, chipped nebulizers, self-monitoring through apps, and text reminders increase medicine compliance in patients with asthma, copd, and cystic fibrosis (cf) ( ) . furthermore, the diagnosis of copd through telemedicine means such as spirometry tracing and teleconsultation provides an opportunity to utilize technology to increase patient care. further studies are needed to stratify which patients, in terms of severity, will be best suited to a telemedicine management approach. another area of potential growth is in using ai algorithms to determine developing copd exacerbations ( ) . telemedicine for asthmatics tends to be more focused on treatment compliance and self-monitoring and can be useful in helping patients learn more about their disease, such as recognizing patterns of asthma triggers ( ) . other barriers to care include the risk that patient data may be manipulated, networks potentially becoming compromised, and inconclusive data on the benefit of telehealth on specific diseases such as copd ( ) . obstructive sleep apnea (osa) is one such disease in which remote monitoring can be utilized to prevent patients from having to spend time in a sleep clinic or respiratory clinic ( ) . home polysomnography devices can be used to track patients' breathing and oxygen levels; however, further work is needed to lower the rate of false negatives to the level of in-person sleep clinics ( ) . a prospective study of patients used a portable spirometer, with bluetooth capabilities and connected to a mobile phone application, to trace results and connect the patient to a physician for analysis ( ) . this allowed the patient's breathing difficulties to be assessed and categorized as asthma, copd, or normal breathing function ( ) . this study shows promising results for remote diagnosis of chronic breathing conditions; however, it does not preclude the need for future testing in some more complicated cases. other smartphone applications have utilized microphones and questionnaires to analyze and detect breathing difficulties associated with other pulmonary conditions such as coughs and lung cancer ( ) . covid- could impose severe stress on sleep clinics and may limit in-laboratory polysomnography sleep studies for osa assessments and diagnosis. home-based telepolysomnography for osa assessment could be explored so that the delayed diagnosis and the associated impact on patients could be minimized. patients with osa often require continuous positive airway pressure (cpap) while sleeping to improve symptoms and achieve proper rest ( ) . in order to see sustained results, patients need to use cpap for at least h at night, combined with lifestyle changes such as weight reduction and smoking cessation ( ) . low adherence to cpap remains a continuous problem for osa patients due to lack of motivation, discomfort, loud noise, and claustrophobia ( ) . telehealth provides an opportunity to increase cpap adherence by monitoring device output data and patient self-tracking of lifestyle factors. when usage falls, the patient can be contacted to discuss their reasons for low adherence and to motivate them to continue use ( ) . telemedicine could be used to monitor bulbar function in patients with a compromised bulbar function such as als ( , ) . the rapid decline in bulbar function could be captured using technologies that are useful in delivering specialist multidisciplinary care ( ) . other diseases in which bulbar function may be impaired include myasthenia gravis, spinalbulbar muscular dystrophy, and riboflavin transporter deficiency ( , ( ) ( ) ( ) . telemedicine can aid with rehabilitation following acute incidents such as stroke and traumatic brain injury (tbi) ( , ), as well as chronic conditions that require ongoing rehabilitation efforts such as copd, cvd, diabetes, and obesity ( ). stroke telerehabilitation programs involving consultations, exercises, games, and therapy aspects have shown positive outcomes such as improving patients' functional abilities and mental health ( ) . other benefits include increasing patient motivation and ease due to being in a home setting ( ) . it is important that patients receive enough support in areas such as technical setup and troubleshooting. the telerehabilitation in heart failure patients (telereh-hf) trial in poland demonstrated that a -week hybrid comprehensive telerehabilitation (hctr) program consisting of remote monitoring of training at patients' homes was well-tolerated ( , ) . however, the positive effects of the intervention didn't translate into improvement in clinical outcomes over a follow-up period of - months in comparison to standard care ( ) . a systematic review similarly found that telerehabilitation allowed for equal or more significant patient outcomes than center-based rehabilitation programs in stroke ( ) . furthermore, wearable devices can be used in the rehabilitation of various neurological diseases such as stroke, pd, multiple sclerosis, and tbi. inactivity is associated with various comorbidities and is often a result of chronic neurological disease or acute accident recovery. remote monitoring through wearable devices can track activity, gait, and any falls throughout rehabilitation ( ) . tbi can result in cognitive issues such as sleep disturbance, photophobia, memory, and behavioral changes ( ) . it is crucial that patients are not discharged without a follow-up plan. a neuropsychological test battery in the few years following moderate-to-severe brain injury and inpatient rehabilitation is vital to assess any cognitive decline and plateau. during covid- times, it is necessary to move outpatient testing of this sort to remote delivery, wherever feasible and while maintaining efficacy. the brief test of adult cognition (btact) has been shown to be effective over the telephone in patients with tbi to assess cognitive state ( ) . remote monitoring of physical activity by physiotherapists and patient consultation with neurologists can also be achieved through telemedicine. however, clear guidelines for rehabilitation management and evidence of efficacy through different delivery systems are lacking ( ) . pulmonary rehabilitation is essential for patients with chronic respiratory issues such as copd and can be achieved through telehealth measures such as monitoring, consultation, and education ( ) . this is important in copd, as potential exacerbations need to be monitored, and lower levels of rehabilitation access are associated with increased rates of hospitalization ( ) . additionally, personal movement tracking devices involving accelerometers are helpful in tracking patient exercise, which is an essential area of pulmonary rehabilitation ( ) . telehealth rehabilitation still faces major hurdles, however, such as cost-effectiveness, patient training, and the lack of regulatory frameworks surrounding personal health devices ( ) . according to the who, about million people annually need palliative care, and only % of them receive it ( ) . the importance of primary healthcare in palliative care was highlighted by the first who global resolution on palliative care in . the project echo (extension for community healthcare outcomes), as one of the examples, shows the potential of telemedicine in the training of patients, their family members, and medical workers in palliative care ( , ) . the training of palliative care via telemedicine/telehealth for outpatients in primary care will increase the coverage and quality of both care and life for these patients. telehealth, including mobile applications, plays a role in making patients more adherent to both pharmacological and non-pharmacological therapies; in remote monitoring of clinical parameters such as cardiovascular and respiratory system function; as well as in monitoring of diet and physical activity. given the overload of respiratory diseases and the flu-like presentations in routine practice, telemedicine offers an alternative that is particularly relevant in the covid- era. mental health support to frontline health workers, patients, and carers will be crucial, as long isolation, lack of social interaction, as well as anxiety over one's own and others' health will take a toll on well-being ( ) ( ) ( ) ) . psychotherapy, psychiatry, and counseling are easily converted to a teleconference format through platforms (such as-but not limited to-zoom tm and skype tm ) and should be utilized by frontline health workers, patients, and carers where necessary ( ) . anecdotal evidence also suggests that patients experiencing paranoid, anxiety, or post-traumatic stress disorders, who may be particularly affected by the covid- climate ( ), may feel more comfortable undergoing telepsychiatry over in-person psychiatry. online delivery will further help to resolve issues such as lack of access to practitioners in rural settings and cultural and linguistic barriers ( ) . furthermore, psychoeducation and mental well-being advice can be leveraged through smartphone apps and digital outreach programs ( ) . these services will become increasingly crucial in the pandemic setting, as physical isolation and frontline work pose both access issues and mental health stressors. the ethics of such teleservices needs to be ensured, with patient confidentiality, referral and billing practices, and physician eligibility being upheld ( ) . psychiatrists, psychotherapists, and psychologists need to ensure that they are maintaining their own mental health during this time, with programs such as professional supervision being of help ( ). in , nearly one-fifth of the european population was aged over years old ( ) . an aging population has put significant pressure on public spending; therefore, telemedicine can improve the scale and efficiency of delivery and ongoing management of elderly patients. elderly patients with mild cognitive impairment or dementia who might be at high risk of an acute condition should be identified using mobile technologies and telemedicine, and telemedicine solutions for the elderly should be easy to use and possibly automatic ( ). this would avoid unnecessary burdens to public health facilities. telemedicine can also be used to act as an interface of the local nursing care staff, carers, and patients with medical specialists. elderly patients will benefit from remote allied health delivery. patients who have had a recent surgery could be monitored at home or in nursing care facilities, preventing extended hospital stays. elderly patients with diagnosed mental health conditions could also benefit from telemedicine. however, self-efficacy and digital literacy presumably have a significant impact on the uptake of telehealth among the elderly ( ) . recent data from the us confirm that the most vulnerable age group for covid- is people over years old, and the highest mortality is observed in those aged and older ( ) . in ontario, canada (as well as in italy and the us), % of deaths related to covid- occurred in retirement homes and long-term care ( , ) . strict zero-visitation policies have had debilitating effects for some elderly patients, particularly those with dementia ( ). telemedicine has been utilized to connect family members with these patients to prevent further decline in mental status and provide comfort. this is useful, as family members have voiced concerns that physically distanced visits such as through windows may further confuse their loved ones. telehealth allows continual monitoring of vitals, physical examination, ongoing clinical management, and communication with patients. in elderly patients with limited accessibility, telemedicine could provide an alternative, easy-to-access service. elderly patients often suffer from social isolation, and telehealth can bring a sense of community. furthermore, by using ai, falls can be detected among elderly patients ( ) . ai can provide personalized medicine solutions to help identify patients at risk of harm. primary healthcare physicians and nursing homes should watch for signs of depression in the elderly, particularly as it has been shown that telemedicine is competent in managing depressive symptoms in the elderly ( ) . telemedicine can be useful in delivering interventions in congregate settings ( , ) . challenges in congregate settings include high population density, limited mobility, built environment issues, and limited access to health. this can make the prevention and management of covid- onerous while preserving human rights and ethical issues. some of the potential target populations include refugees and migrants ( ) , those living in incarceration, orphanages, old-age homes, or childcare centers; and schools. these populations are especially vulnerable to infection such as covid- , where an outbreak can have facility-wide implications and adverse health consequences and fatality. a simulation study on the possible impact of covid- outbreak in a bangladeshi refugee camp found a dire need for dramatic increases in healthcare capacity and infrastructure ( ) . existing approaches to control an outbreak, should it occur, would not be practically feasible, necessitating innovative solutions as well as novel and untested strategies in humanitarian settings ( ) . telepsychiatry to monitor and deliver interventions in congregate settings, especially among refugee populations living in resource-constrained areas ( , ) , could be an alternative when traditional therapy is not possible. telepsychiatry programs for congregate settings should be developed, and further studies are needed to evaluate their long-term impact on patient monitoring and care ( , ) . telemedicine systems are not novel concepts and have been used to good effect for programs such as forward triage in eds, critical care monitoring, and physician communication. existing systems will need to be reallocated, and innovations will be pushed through in order to provide care across all medical fields and to reduce hospital burden. this needs to be achieved within the constraints of funding, legislation, and supply-chain barriers. temporary government funding will be necessary to roll out telemedicine to both rural and urban settings, as well as relaxations to legislation that allow practitioner reimbursement of telemedicine services ( ) . a study by sayani et al., addressing the cost and time barriers in chronic disease management through telemedicine in lmics, found telemedicine to be economically beneficial not only by reducing the socioeconomic barriers to cost and access but also by increasing the uptake of services ( ) . another systematic review of studies conducted on costs of home-based telemedicine programs from to found that home telemedicine programs reduced care costs, although detailed cost data were either incomplete or not presented in detail ( ) . the data on the cost-effectiveness of telemedicine solutions in different medical areas remains inconsistent and confounded by many variables, including the type of disease and "digital maturity" of healthcare systems. however, in critical situations such as the covid- pandemic, telemedicine is proven necessary, and costing, billing, and reimbursement solutions are needed. there are variations in reimbursement policies across regions and healthcare systems. one of the major barriers has been harmonizing a standard reimbursement policy that is acceptable to all stakeholders and sustainable. we recommend that an integrated framework involving public and private parties could help develop a less complicated and streamlined reimbursement structure. notably, the adoption of a "flip the switch" health insurance strategy in north carolina to reimburse telehealth visits "at parity" with conventional office visits for all healthcare providers and specialists is timely and essential. in the long term, the impact of these strategies on healthcare quality and healthcare costs needs further study. healthcare providers must lead the way here in the covid- crisis to explore innovative approaches such as b b monitoring. certain limitations may act as roadblocks in the uptake, implementation, and scale-up of telemedicine and supporting technologies. considerable training is required to ensure patients can familiarize themselves with video teleconsultations and the use of supportive technologies. physicians also need targeted technical, clinical, and communication training based on their subspecialty needs. issues of limited access to broadband and internet facilities are an area that particularly limits the deployment of telemedicine in remote areas and under-resourced settings. telehealth requires reliable broadband access, which is not always acceptable both for clinics in rural areas and for patients living in such areas. when using telemedicine technology, legal restrictions and a lack of clarity as to what is permitted are possible, and these restrictions force telemedicine providers to proceed with caution. some conditions are not considered in the legislation of health systems. it is still not entirely clear whether virtual consultations and video surveillance will be fully paid in hospitals or will be evaluated as shorter visits so that the rates will be lowered. physician licensing and stability of the telemedicine infrastructures are issues of relevance in under-resourced settings. several critical medical procedures cannot be replaced by telemedicine, nor can it be offered to everyone, and there are many excluded groups of patients, including those with deficiencies (e.g., deaf and blind patients) and elderly patients. the effectiveness of telemedicine relies on the possibilities of the implementation of these tools in the given hospital/healthcare system, preparations/training of physicians/nurses, and awareness of the patients. figure | text, audio, or video means. effective telemedicine has several requirements, including culturally appropriate and available infrastructure; regulatory oversight and privacy compliance such as through the health insurance portability and accountability act of (hipaa); integration of technologies with existing data such as electronic health records (ehrs), apps, and monitoring devices; and insurance coverage such as medicare or private-payer schemes. credentialing on both sides is essential. the consultation should start with verification of the patient's identity through name, age, phone number, date of birth, and address. the physician should then clearly specify that this is a telemedicine consult and that no audio or video of the communication will be recorded. it is imperative that health record information is protected. the physician should then clearly and explicitly ask for consent, whether that be verbal, text, or video. at the start of the consultation, the physician should assess if acute care is required and make a cursory determination if telemedicine consultation is sufficient. if necessary, the physician should supply an immediate referral or advise the patient to seek immediate medical attention. during a typical consultation, the patient will be evaluated; and specific diagnostics and treatment would be recommended based on the assessment of the healthcare provider; and follow-up could be scheduled either in person or virtually. the physician should go through records, clinical history, and investigations including pathology and diagnostic reports, and obtain any additional information that the patient can provide. a general, non-specialist examination should be obtained, and any vital signs that the patient has the means to measure should be gathered. beyond this, when introducing technologies and measures to overcome gaps in the healthcare system, it is essential not to simply ask, "where are the gaps, " but also to define the standards and ideals of care and continually iterate toward these ideals. as mentioned before, telemedical consultations do not approach the same level of fidelity that an in-person physical exam yields, between physical exams, body language, vocal intonations, and odors. as such, the fidelity of the technology involved with telemedical consults must continually iterate to reach the same level of fidelity and information that an inperson visit might yield. in this vein, virtual and augmented reality technologies, while evolving, hold promise for the future of telemedicine, particularly in envisioning a future in which high-fidelity physician and patient "avatars" may meet in a virtual space for a telemedical consult, replicating aspects of an inperson visit through immersive technologies. covid- has expedited the uptake of telemedicine across various specialties. the rapid move by various bodies, associations, and providers to use telemedicine in maintaining patient continuity while limiting covid- risks of exposure to patients and healthcare workers will have a long-term impact well-beyond the current pandemic. teleconsultation needs are varied across specialties, and therefore, specialty-specific guidelines and recommendations need to be developed. a scoping list of various telemedicine studies across medical subspecialties (telemedicine vs. standard care) has been provided in table . a comprehensive workflow that critically profiles various telemedicine enablers has been proposed in figure , and recommendations to improve various factors are listed in table . the proposed workflow (figure ) provides a practical telemedicine framework cognizant of relevant requirements and considerations, and a step-by-step pathway to streamlined telemedicine delivery. this could be used as a template (for further customization or adaptation) by individual medical subspecialties. current challenges and recommendations to improve telemedicine include ( ) : (i) infrastructure capacity [formation and expansion of dedicated telemedicine units and workforce; cloud-based infrastructure to support telemedicine associated bandwidth traffic; liability, maintenance, and safety of telemedicine platforms; ongoing and regular maintenance and servicing of telemedicine hardware and software; awareness, education, and training to build confidence about telemedicine use among providers and consumers; compulsory telemedicine modules for medical students and continued professional development (cpd) workshops/courses for healthcare providers and medical informaticians/technologists; targeted courses aimed at re-skilling clinicians]; (ii) integration with existing data (standardized patient-specific information and consent form with telemedicine opt-in/out option); (iii) regulatory oversight issues (setup of telemedicine regulatory authority; accreditation/licensing of providers using telemedicine; guidelines for telemedicine use in inter-state and -nation settings; standardization of telemedicine related technologies and services with regulatory oversight, audit, and reporting; appropriate measures and oversight to protect privacy, security, and confidentiality of patient data; legal frameworks for telemedicine-specific information storage, sharing, and access); and (iv) insurance/payers (guidelines for telemedicine insurance; streamlined payment facilities for making and receiving payments; bundled services payments and insurance coverage). another important and emerging area is the use of text messaging [short message service (sms) or multimedia message service (mms)] as a model for service delivery ( ) ( ) ( ) ( ) ( ) ( ) . text messaging has proven efficacious in diabetes self-management, smoking cessation, weight loss, physical activity, and adherence to medication regimens [such as in human immunodeficiency virus infection and acquired immune deficiency syndrome (hiv/aids) patients who are on antiretroviral therapy] ( ) . a systematic review on text messaging interventions identified the following issues: identification of intervention characteristics, ensuring intervention effects last over a longer duration of time, and cost-effectiveness of these interventions ( ) . issues of privacy and security are also poignant in this context. nevertheless, text messaging offers potential benefit as a public health intervention toward chronic disease management ( ) ( ) ( ) ( ) , medication adherence, and secondary prevention ( ) . perceptions and experiences/satisfaction, regarding telemedicine services, of the patients and providers is important in improving telemedicine implementation, delivery, and impact ( ) ( ) ( ) ( ) ( ) . a systematic review on patient satisfaction with telemedicine highlighted methodological deficiencies in published studies ( ) . a study on patient and clinician experience with telemedicine found that virtual video visits may provide effective follow-up and increased convenience in comparison to routine in-person visits ( ) . another study found a perception of patients with type diabetes that telemedicine can improve their access to care ( ) . further studies focusing on communication issues and the quality of interpersonal relationships during telemedicine consultations and how these factors affect healthcare delivery using this medium are required ( , ) . some specialist examinations, including neurologist consultation, can also be conducted. the american academy of neurology has issued guidelines for telemedicine consultation ( ) . physicians can assess mental status; any visual, auditory, or cognitive deficits; comprehensive speech; cranial nerves; apparent tremors; and gait. motor examinations can also be conducted with the aid of a caregiver in order to help ascertain strength, tone, reflexes, dermatome sensation, and cerebellar function. in such a case, consent must be gained from both the patient and the assistor. special considerations may apply for pediatric patients or adults with intellectual disabilities. based on the severity of symptoms, the patient may require a management plan, including specific treatment, health education, and counseling if necessary. patients can be prescribed ongoing prescriptions, specific medications, or add-on medication to optimize regimes, given that there is no ambiguity about diagnosis and the medications are not dangerous. if there is any ambiguity about diagnosis, this must be recognized as a limitation of this mode of telemedicine, and documentation must be made. further tests should be done or referred for in-person consultation if necessary. it should be noted that detailed examination of tone, strength, and reflexes; comprehensive eye examinations; and examinations that require specific maneuvers such as vestibular examinations should be avoided, as examination findings won't be accurate. these recommendations will also need to be adjusted according to individual state or federal legislation. the future of telemedicine beyond the current covid- pandemic will depend on how we address existing challenges, building resilient health systems ( ) ( ) ( ) . further randomized controlled trials to evaluate the long-term effects of telemedicine-based interventions in various patient populations should be planned. telemedicine will play a major role as a "safety net" during the pandemic. the covid- pandemic is causing an unprecedented public health crisis impacting healthcare systems, healthcare workers, and communities. the covid- pandemic health system resilience program (reprogram) consortium is formed to champion the safety of healthcare workers, policy development, and advocacy for global pandemic preparedness and action. sbh devised the project, the main conceptual ideas, including the proposal for a new telemedicine workflow, the proof outline, and coordinated the writing and editing of the manuscript. sbh and sbr wrote the first draft of the manuscript. sbh encouraged sbr to investigate and supervised the findings of this work. all authors discussed the results and recommendations and contributed to the final manuscript. we would like to acknowledge the reprogram consortium members, who have worked 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review of the literature telemedicine and covid- implementation guide conflict of interest: sp is the vice president of immersive medicine at luxsonic technologies, a medical technology company specializing in virtual/augmented reality for medical education, collaboration, and training. the opinions expressed in this article are those of the authors and do not necessarily represent the decisions, official policy, or opinions of the affiliated institutions.the remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.copyright © bhaskar, bradley, chattu, adisesh, nurtazina, kyrykbayeva, sakhamuri, moguilner, pandya, schroeder, banach and ray. this is an open-access article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- - qpu xrb authors: naik, b.sadananda title: can a health care worker have sex in the time of covid- ? date: - - journal: eur j obstet gynecol reprod biol doi: . /j.ejogrb. . . sha: doc_id: cord_uid: qpu xrb covid- is not transmitted by sex but close proximity during the act could aide in spread of the disease. health care workers by virtue of the nature of their work have higher chances of exposure to the virus and them indulging in sex needs risk reduction strategies. showing the transmission of the infection by sexual contact as the infected persons and those who recovered have shown presence of virus in their semen. [ ] health care workers are by virtue of the very nature of their work, theoretically do get exposed to the virus on a daily basis despite of adequate safety precautions though they could be considered low risk exposures as per cdc norms. [ ] however, decisions regarding living in close intimacy or self-quarantine throughout the period of hospital work is purely a personal decision as there are no evidence-based guidelines available at present. use an alcohol-based hand sanitizer. so, it is imperative that a health care worker while indulging in sex life during time of covid- to follow strict risk reduction strategies to self and the partner in the best interest of the community at large. however, as the knowledge regarding this novel virus is continuously evolving on regular basis, we have more questions than answers at present. funds received: nil ethical clearance: not applicable j o u r n a l p r e -p r o o f pathophysiology, transmission, diagnosis, and treatment of coronavirus disease (covid- ): a review china medical treatment expert group for covid- . clinical characteristics of novel coronavirus infection in china clinical characteristics and results of semen tests among men with coronavirus disease sars-cov- is not detectable in the vaginal fluid of women with severe covid- infection key: cord- -c y rtb authors: chiara, berardi; marcello, antonini; mesfin g, genie; giovanni, cotugno; alessandro, lanteri; adrian, melia; francesco, paolucci title: the covid- pandemic in italy: policy and technology impact on health and non-health outcomes date: - - journal: health policy technol doi: . /j.hlpt. . . sha: doc_id: cord_uid: c y rtb italy was the first western country to experience a major coronavirus outbreak and consequently faced large-scale health and socio-economic challenges. the italian government enforced a wide set of homogeneous interventions nationally, despite the differing incidences of the virus throughout the country. objective: the paper aims to analyse the policies implemented by the government and their impact on health and non-health outcomes considering both scaling-up and scaling-down interventions. methods: to categorise the policy interventions, we rely on the comparative and conceptual framework developed by moy et al. ( ). we investigate the impact of policies on the daily reported number of deaths, case fatality rate, confirmation rate, intensive care unit saturation, and financial and job market indicators across the three major geographical areas of italy (north, centre, and south). qualitative and quantitative data are gathered from mixed sources: italian national and regional institutions, national health research and international organisations. our analysis contributes to the literature on the covid- pandemic by comparing policy interventions and their outcomes. results: our findings suggest that the strictness and timing of containment and prevention measures played a prominent role in tackling the pandemic, both from a health and economic perspective. technological interventions played a marginal role due to the inadequacy of protocols and the delay of their implementation. conclusions: future government interventions should be informed by evidence-based decision making to balance, the benefits arising from the timing and stringency of the interventions against the adverse social and economic cost, both in the short and long term. the novel coronavirus (covid- ) has been declared a global pandemic by the who, with countries registering coronavirus outbreaks. governments have put in place various interventions to respond to the rapid growth of infection and death ( ) which have had considerable negative impacts on society. with no covid- vaccine available, countries have been relying on non-pharmaceutical public health interventions ( ) . mitigation and containment strategies were targeted to flatten the contagion curve and reduce the rate of transmission, and to ensure the sustainability of health care systems in dealing with limited icu capacity and equipment. the international experience suggests that technologies such as contact tracing, drones and robots have played a crucial role in the fight against the virus in some countries, however the experience is mixed and their overall effectiveness is still uncertain. ( ) . italy was the first western country to experience the covid- emergency with a spiral of infections and deaths placing the country at the top of the international rankings, overtaking china on th march . the covid- burden has challenged the cost and sustainability of regional healthcare systems and the concomitant safety of healthcare professionals, requiring a + . % gdp increase in public health expenditure compared to the previous year for hospital reorganisation, community infrastructure, health personnel recruiting and equipment supply ( ). the incidence of the virus has been particularly severe in northern regions, moderate in central regions and mild in the southern regions of italy ( ) . the italian government implemented a wide range of measures to balance the complex trade-offs between ethical, public health, legal and economic problems. in the early phase of the epidemic, the italian government applied targeted measures to the most affected areas. as of th march , the policy interventions were extended homogeneously to all the regions despite the varied severity of the spread. the national exit strategy plan announced at the end of april began on th may with the gradual relaxation of containment measures carried out in three different phases. this paper aims to investigate and assess policy interventions implemented in italy and the impact on health and non-health outcomes. the literature offers different measures providing a systematic cross-country tracking of covid- policies ( , ( ) ( ) ( ) . our analysis considers a set of interventions with targeted objectives in the escalation and de-escalation phases across italian regions from nd january to nd august . the remainder of this paper is organised as follows. in section , we present an overview of the health profile of the population and health care system of italy. section presents the analysis of covid- epidemiological trends at national and regional levels. in section , we describe and analyse scaling-up and scaling-down policies implemented in italy based on a comparative conceptual framework ( ) . this section considers various interventions such as measures to contain the spread of the virus, policies for prevention and cure, interventions for economic stimulus, and the introduction of new health technology. section gives an overview of the response of the health care system. in section , we discuss the long-term challenges and spillover effects arising from the pandemic and associated government interventions. the final section presents the implications of our results for policy and draws conclusions. it is important to understand italy's demographic and epidemiological features to recognise the factors associated with covid- . with a population of over million and a surface area of over , km , italy is one of the largest and most populous countries in europe. it is a highly developed country ( ) , with the eighth largest economy in the world. the government is a parliamentary republic, with a multi-level governance system across twenty administrative regions and provinces and metropolitan cities. the italian constitution recognises health as a fundamental individual and collective right and stipulates that care should be guaranteed to disadvantaged people ( , ) . this is reflected in the italian healthcare system (servizio sanitario nazionale, or ssn), established in to provide universal coverage to all citizens, eu nationals, and legal residents. further, emergency and basic services are provided for undocumented immigrants. since , health policies and constitutional reform have driven a decentralisation of the ssn ( ) . the decentralisation is reflected in the financing, provision, and governance of the twenty regional health systems (see in table in the appendix). regional models range from integrated model to a quasi-market in lombardy ( ) . italian healthcare expenditure amounts to . % of gdp, on par with oecd average ( ) . the general budget is pooled nationally and distributed to the regions. in , government compulsory healthcare expenditure per capita was usd , (ppp), below the oecd average of usd , ( ) . across regions the healthcare expenditure per capita is heterogeneous, ranging from usd , in campania to usd , in friuli venezia giulia ( ). national government financing accounted for . % of total health spending in , while out-of-pocket payments for . % and voluntary schemes for the remaining . % ( ). arguably, having one of the best healthcare systems worldwide ( , ) , italy has the second highest life expectancy at birth ( . years) among european countries, and the eighth highest in the world ( ) ( ). as a result, its population (median age . years, % over years) is the oldest in europe and the second oldest in the world ( , ). italy's longevity is associated with high morbidity rates, with % of the total population having a chronic condition, and nearly % being affected by multi-chronic conditions ( ) ( ) . behavioural risk factors such as diet, tobacco smoking, high body mass index, alcohol consumption and low physical activity levels contribute to the italian population burden of disease ( ). empirical data confirms that age and morbidity are factors associated with covid- mortality ( ) (see table in the appendix). among the deaths recorded in the sample period, .% are older than years, and % had at least one underlying comorbidity/condition ( ) (see figure in the appendix). in the early stages of the pandemic, the incidence was higher amongst men, however, in april, the distribution evened out (see figure in the appendix), limiting the role sex plays in the incidence of mortality arising from the diseases. as of st july , % of confirmed cases were female (see figure in the appendix in italy, covid- data is made available by different institutions at national and regional levels. the inconsistency of data between different administrative levels has been a major issue (see table in the appendix). the italian government started to publish data on th february , with a reasonable degree of transparency, but only a moderate level of accessibility. important data such as icu survival rates, hospitalised patients' outcomes, number and occupation of new beds introduced since the emergency are still missing (see table in the appendix). this section describes the epidemiological trend of covid- throughout the country. covid- appeared in italy in late january , when two chinese tourists tested positive. one month later, patient was detected in lombardy. in the following days, lombardy and veneto became the two initial clusters of infection, experiencing a rapid escalation of cases. increased surveillance, through contact tracing and testing of both symptomatic and asymptomatic persons exposed to positive cases, revealed that the virus had already been spreading in many municipalities of southern lombardy since january ( ). the contagious nature of covid- caused cases to rapidly spread throughout the country ( ). nationally, the peak of contagion to compare the epidemiological figures at the regional level, we used the day each region's th case was confirmed as the start of that region's outbreak. similarly, for the numbers of deaths, we used the day the th fatality was recorded. we arbitrary set these starting points to reduce potential bias of the testing strategy and deaths recording at the beginning of the outbreak. figure in the appendix shows the distribution of covid- cases and fatalities in italy. lombardy was the most affected region followed by veneto, emilia romagna and piemonte. to compensate for the likely underestimation of cases due to the classification method and the testing strategy, the italian bureau of statistics (istat) compared the excess deaths recorded in the first four months of with the average number of deaths across all causes in the first four months of - ( ). this empirical analysis covers a sample of italian municipalities ( % in march, % in april and . % in may). as a result, the integrated surveillance indicates that % of excess mortality registered in march, % in april and . % in may can be attributed to covid- . the unexplained number of deaths might be attributed to three main causes: i) the higher mortality associated with the cases that were not tested; ii) indirect mortality in untested patients who died from organ dysfunctions possibly caused by covid- ; and iii) indirect mortality due to strains on the healthcare system in the most affected areas ( ). the italian government declared a state of emergency on st january . as the first western country to experience a major outbreak of covid- , italy was faced with escalating crisis in a period of extreme uncertainty. in the absence of a covid- vaccine, the only measures to contain the spread of the virus are case isolation, contact tracing and lockdown measures. the decentralised nature of the italian health care system combined with the heterogeneous epidemiological incidence at the regional level created the need for a diverse set of policies responsive to emerging patterns, rather than a one-size fits all approach. the policy interventions ( ) are categorised as follows: . policy interventions to contain the spread of the virus (behaviour, containment, mitigation) (see roadmap and table in the appendix); policy interventions for prevention and cure (treatments, health monitoring) (see roadmap and table in the appendix); technological interventions for testing, tracing and treating (see roadmap and table in the appendix); each policy categorisation has its own spectrum of escalating and de-escalating measures. the escalation implies the implementation of stricter or more invasive policy intervention, while the de-escalation implies the opposite. scaling-up and scaling-down interventions are ranked on an ordinal scale gradient that ranges from to , where policies are classified as none ( ); minimum ( ); medium ( ); significant ( ); very significant ( ) based on their significance and invasiveness. therefore, the upper extreme of the gradient gathers the implementation of all the other measures that belong to the lower levels of the spectrum. for instance, referring to the policy interventions to contain the spread of the virus, the significance gradient ranges from no restriction to enforced lockdown ( table in the appendix). looking at the technology interventions, the gradient measures the invasiveness ranging from no interventions to centralised gps contact tracing ( table in the appendix). the comparative and conceptual framework ( ) uses a systematic approach to categorise policies targeted to specific objectives. it is a tool to assess the impact of policies on different sets of health and non-health related outcomes. we focus our evaluation on the following outcomes: daily reported number of deaths; case fatality rate; confirmation rate; icu saturation; ftse mib index value; and unemployment rate. despite death data might be biased as mentioned above, daily reported number of deaths and case fatality rate are selected to represent epidemiological outcomes. such outcomes are preferred to the confirmed cases indicators as the number of fatalities is less likely to be underestimated due to the country testing strategy ( ) . furthermore, the case fatality rate provides an estimate of the daily severity of the disease over time. icu saturation reflects the response capacity of the healthcare system. the confirmation rate shows the testing strategy variation over time, ceteris paribus . the financial and economic indicators reflect the investors' expectations of the italian economy. the unemployment rate provides a measure on how the containment measures impact the job market and the productivity nationally. we break down the analysis at regional level for all of the outcomes except for the ftse mib index value and unemployment rate, which are at national level. the analysis does not include other relevant health and non-health outcomes due to data availability or inconsistency during the period considered (i.e. length of stay in hospital, readmission rate, icu death rate and survival rate, public and private health care expenditure, public and private bed and personnel repurposing, public and private service provision, domestic violence, mental health demand). as a robustness check, the outcomes considered are compared with the oxford covid- government response tracker that includes the response, stringency, containment and health and economic support indices ( ). we report an overview of the policy categorisation considering their major impact on some outcomes of interest. among the four policy categories mentioned above, categories and are combined as there is an overlap between the preventive measures and the technology development and utilisation. in the absence of a covid- vaccine, the introduction of health resources and technology plays a fundamental role in preventing the spread of the virus. roadmap reports the principal interventions adopted by the italian government relative to the triple ts strategy: testing, tracing and treatment. technological solutions using geolocation tools have been used with success to control the spread of the virus in china, singapore and south korea ( ) . the effectiveness of such technologies relies on wide adoption, however, one possible barrier to this is the perceived invasiveness and potential breaches of privacy ( , ) . during the outbreak, the ministry of health issued national guidelines for testing. the testing criteria were updated at later stages (see table in the appendix), adopting who and european commission recommendations. the strictness of the criteria reflected the necessity to ration the supply of swabs, reagents and laboratory capacity. despite the national guidelines, a homogeneous testing strategy has not been consistently applied over time, across regions, neither in terms of number nor modality ( ) (see figure in the appendix). amongst the three most affected regions, lombardy ran fewer tests than veneto and emilia despite the huge expansion of the digital health sector in italy (with % increase, i.e. . billion euro), digital health strategies are decentralised, resulting in inconsistent utilisation across different regions ( ) . the covid- pandemic and the related lockdown measures have led to unprecedented economic costs around the world. the pandemic is a global shock that has affected the international economy, from financial markets where asset prices have decreased and volatility has increased characterising both the impact and future uncertainty involved with the pandemic ( ), to the impacts on the supply-chain ( ) . decision-making necessary to prevent an economic collapse in such a context involves a trade-off between public health and economic prosperity ( , ) . using some micro and macro indicators, this section shows that italy has suffered roadmap describes the principal economic interventions implemented by the substantial economic losses. italian government and the european central bank. to prevent the economic collapse of the country, italy has implemented several fiscal policies. the two most significant policies were the "cura italia" decree implemented on th march and the "decreto liquidità" implemented on the th april . the "cura italia" brought an immediate tax boost of billion euro to help most affected sectors, strengthen the healthcare system and provide unemployment benefits. the "cura italia" decree was reinforced when the council of ministers approved the "decreto liquidità" (decree-law of th april , n. ), allocating a total of billion euro to assist businesses by offering loan guarantees and a certain targeted tax relief. for instance, it provided billion euro as credit for small and medium enterprises, and injecting liquidity into the banking system. furthermore, the decree earmarks billion euro to support exporting enterprises located in italy to access liquidity. the state and the export credit agency cover respectively % and % of the guarantee to support enterprises financial obligations ( ). despite the substantial fiscal stimulus, the country has experienced the biggest quarterly economic contraction since the financial crisis. according to the latest data provided by the italian bureau of statistics (istat) ( ), the gdp in the first quarter of decreased by . % in comparison to the first quarter of . the overall gdp contraction estimated for is a contraction of . % ( ). the crisis also impacted international trade flows. figure in the appendix shows the monthly index of import and export in millions of euro. in the quarter march-may , despite the growth in may, the economic trend is conditioned by a sharp downturn of the previous months and is largely negative for both exports and imports (respectively - . % and - . % compared to the previous quarter december -february ) ( ). according to the latest data provided by the italian bureau of statistics (istat) ( ), in may , exports record a marked decline on an annual basis (- . %), but with improvements compared to april (- . %), for both the non-eu area (- . % ) and the eu (- . %). compared to exports, the contraction in imports (- . %) is wider and summarizes the drops in purchases from both markets (- . % from non-eu countries, - . % from the eu area). in may , the trade balance is estimated to increase by million euro (from + , million in may to + , million in may ). net of energy products, the balance is + , million euro (it was + , million in may ). considering the domestic market, retail sales recorded a collapse for non-alimentary goods, partly offset by a marked increase in e-commerce (see figure in the appendix). among the non-alimentary goods, the large negative variations correspond to the clothing and fur sector, followed by goods such as games, footwear and travel items. pharmaceutical products also recorded a negative variation ( ).the negative variation recorded in these sectors is likely to impact the economic fabric of the country, mainly composed by small and medium enterprises with limited investments in digitalisation directed toward to the online market. the perceived trade-off between public health benefits and the economic impact seemed to cover a central role in the exit phase as well. until the th april , the government imposed a homogenous exit strategy. as the number of cases decreased, regional governors put pressure on central government to relax some restrictions on economic activities. after th may , the government's policy changed, leaving the exit strategy to be decided by each region. this choice implied a heterogenous re-opening of economic activities, which helped small and medium scale companies to re-start their businesses. after the lockdown, with the de-escalation measures, the government faced a crucial phase in terms of economic recovery. to invert the negative economic trend, the italian government announced a massive fiscal and monetary stimulus on th may . the decree "rilancio" allocated around billion euro in five main areas with the aim of reorganising the hospital network to deal with covid- emergency. additionally, it guaranteed liquidity and support for italian companies, aiding their stability during the emergency period and encouraging their revival at the time of recovery. this section describes the policy implemented by the government to cope with the limited capacity of the health care system and the challenges of the covid- pandemic. the central government is responsible for public health interventions; however, the decentralisation of the italian healthcare system hindered the implementation of a homogeneous strategy. regional health care systems differ widely in terms of hospital organisation (public versus private), equipment (number of beds etc.) and medical workforce ( ). following a decree implemented on st february , the government facilitated the urgent increase of hospital beds in all regions by % in icu and % in pulmonology and infectious disease wards. the measure entailed the immediate redistribution of hospitalised patients to accredited private structures to ease the pressure on the public system. the national health system is composed of % public and % private beds, with substantial regional variations, ranging from . % of public beds in lombardy to . % in basilicata ( ). increasing the number of icu beds appears to have largely prevented saturation, except for lombardy, which experienced an overloading of the system from st april (see figure in the appendix). the available data does not give further information on patient outcomes. patients' length of stay, discharge, re-admission and mortality rate data are necessary to fully evaluate the healthcare system performance and the health policies implemented by the government ( ). the overall standard national health budget increase for amounts to . billion euro with a decree of th march ( ). as part of this budget increase, the government spent million euro to implement the "aid distribution system", distributing disposable and durable medical materials to each region ( ). the most common disposable materials distributed were masks ( %), gloves ( %), and diagnostic kits ( %). durables materials included glasses ( %) and thermometers ( %). veneto received the highest amount of materials and molise the least. between th march and th april , the government also distributed , ventilators, of which % went to lombardy and % to emilia romagna. following a decree implemented on th march , the government committed million euro to hire , medical personnel on six-month contracts. regions autonomously managed this hiring process, making it hard to access the relevant data ( ). on th may, "decreto rilancio" allocates , million euro to national emergency fund and , million euro to strengthen emergency departments and community care ( ). this section has two aims. firstly, we test whether the escalation and de-escalation stringency measures to contain the spread of the virus were justified by the underlying epidemiological trend for all the regions, using the t-test analysis. our goal is to test whether differences in means of scaling-up and scaling-down policies are statistically significant. the daily death trend is chosen as the indication of the epidemiological trend. secondly, we describe through a graphical analysis how the health and non-health outcomes were impacted by the policies presented in the conceptual framework. the graphical analysis aims at evaluating if differences in the levels of the policies gradient have had a detectable impact on given outcomes across different areas of the country and may be assessed over different lags of time . in the absence of a counterfactual scenario, we run a t-test analysis on the mean of the daily number of deaths for each region throughout the period of each single policy (see table ). the analysis defines whether the difference in the daily number of deaths between each containment policies implemented in the escalation and de-escalation phase is statistically significant to justify the implementation of a more or less stringent policy. despite the death trend might be influenced by other policy interventions (such as increase of the icu capacity and more effective preventive method), it still is more reliable compared to other epidemiological measures. the analysis covers the period th february to th august . a value between (no intervention) and (very significant intervention) is assigned to each policy to represent its strictness (see table in the appendix). the policy classifications of lombardy, emilia romagna and veneto are displayed in three separate columns since targeted lockdown measurers were implemented before the national lockdown (see table in the appendix). overall, the escalation measures were found to be justified by the underlying death trend. considering the very that the enhanced testing capacity corresponds to the flattening of the case fatality rate and to a reduced confirmation rate (see figure in the appendix). in early march , significant containment interventions were required to ensure the sustainability of the italian healthcare system, especially in northern regions. the lockdown implemented on the th of march , and the closure of business activities of the nd march coincides with a decreasing trend in daily mortality, especially in northern regions in late march (see figure in the appendix). faster policies escalation in the epicentre of the pandemic might have resulted in a lower peak of deaths, flattening the contagion curve (see figure in the appendix). despite the substantial distribution of equipment throughout the regions, the icu wards were close to full capacity in the northern regions. although northern and central regions faced a similar increase in the saturation rate until th march , the lockdown timing seemed to be effective in the central and southern regions where the severity of the contagion was mitigated, starting to flattener before than in northern regions (see figure in the appendix). the case fatality rate stabilisation coincides with the government's announcement of the exit strategy at the end of april (see figure in the appendix). during the period considered in the analysis, the government did not invest resources for the development of tracing technology, which was instead developed for free by a private company. on th may , at the start of the exit phase, the government launched a seroprevalence study on a sample of , individuals. however, significant technological interventions seemed to be far from having any impact on the outcomes considered (daily number of reported deaths and icu saturation) due to delayed implementation (see figure in the appendix). the case fatality rate flattened, and the confirmation rate decreased even though minimal technological interventions were in place (see figure in the appendix). the impact of significant technological interventions could be better assessed if a second wave of covid- (or similar diseases) were to occur in the future. the stringency of the measures is negatively correlated with socio-economic factors. figure in the appendix shows an inverse relationship between the stringency of the containment measures and the stock market index value. figure in the appendix shows the daily performance of ftse mib and the response to major fiscal stimulus packages in italy. the period from february to mid-march saw some of the most significant daily drops in the performance of ftse mib index. following the two major decrees, "cura italia" and "decreto liquidità", it recorded an increase. in particular, the week beginning th march showed an increase in ftse mib (see figure in the appendix). since th may , the ftse mib index has steadily increased, in response to the stimulus and improving expectations surrounding the recovery effort associated with covid- . the lockdown and the subsequent closure of most activities also affected the job market although the unemployment rate did not entirely reflect the lockdown effect due to the reduction in the labour force that decreased by % in april compared to january decreasing ( ) (see figure in the appendix). the results displayed in this analysis are consistent with the oxford covid- government response tracker indices (see figures , , and in the appendix) ( ). covid- also had a huge impact on patients' access to health care, essential services, and education facilities. the high saturation rate in icu due to a large number of severe covid- cases caused a . % decline in organ donation. as of th march , schools and universities closed their facilities and began offering online classes. although online schooling may represent an effective means of education provision, access is dependent on the availability of internet connection and electronic equipment (i.e. computer, laptop, tablets). with schools remaining closed during the exit strategy, and concerns for a potential second wave in autumn, the inequality in access may persist, with potential long-term consequences. the outbreak of covid- significantly affected italy with severe health, social and economic consequences. the production of future government policy; with the transparency and ready availability of data essential. evidence-based interventions is relevant for reducing uncertainty around the interventions, thereby maximising the resource and investment allocations. a detailed appraisal of the data management system between regions and central government is missing and represents a limitation for further studies. the threat of future pandemics should drive the government's investments and resources to prevent and promote public health, strengthening community and territorial services, which demonstrate to be particularly successful in some regions to respond to health services organisation and delivery challenges. as far as the sustainability of the healthcare system is concerned, policymakers should focus on the elaboration of the promotion, prevention and early intervention framework to prevent suicide and lower the long-term impact on people's mental health due to isolation, social distancing and high stress levels. mental health programs should be targeted for different population groups, prioritising those at higher risk. moving forward governments need to identify and implement plans to mitigate the negative effects of a pandemic on vulnerable groups across society which includes elderly in the home care facilities, students, families with children and the impacted workforce. ischemic heart disease ( %) atrial fibrillation ( . %) chronic renal failure ( %) chronic obstructive pulmonary disease ( . %) dementia ( . %) active cancer in the past years ( . %) hearth failure ( . %) source: data provided by iss ( ) ( ) prime minister signed "phase " decree-starting from the th may. it has three phases . from the th may: ) parks reopening; ) free movement in the same region; ) free movement in different regions has to be justified by heath, work reasons; ) relatives visiting with personal protections; ) sport activities is allowed at meters social distancing form others; ) athletes training will be allowed for individual sports; ) funeral ceremonies open air: people maximum; ) bar and restaurants take away; ). restart of activities: manufacturing, building companies, transportations respecting security and hygienic -new security guidelines . from the th may: ) reopening of commercial activities, museums, libraries; ) team sport activities allowed. from the  programs of the biomedical and telemedicine sector,  strengthening of the national system of production of medical devices and  services aimed at the prevention of health emergencies / / significant ( ) decree 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italia: dalla riforma legislativa alla riforma costituzionale. institute of public policy and public choice-polis quasi-market and cost-containment in beveridge systems: the lombardy model of italy. health policy world health organization. the wold health report : health systems: improving performance most efficient healthcare world bank -world development indicators. life expectancy at birth, total (years) population structure and ageing patologie croniche in costante aumento in italia con incremento della spesa sanitaria. la cronicità non colpisce tutti allo stesso modo: si confermano le diseguaglianze di genere, territoriali, culturali e socio economiche geographical tracking and mapping of coronavirus disease covid- /severe acute respiratory syndrome coronavirus (sars-cov- ) epidemic and associated events around the world: how st century gis technologies are supporting the global fight against outbreaks and epidemics quantifying sars-cov- transmission suggests epidemic control with digital contact tracing on the responsible use of digital data to tackle the covid- pandemic lessons from italy's response to coronavirus: harvard business review coronavirus, si estende in emilia-romagna il test drive-through: tamponi direttamente dall'auto covid- italia -monitoraggio della situazione survey nazionale sul contagio covid- nelle strutture residenziali e sociosanitarie the unprecedented stock market impact of covid- (no. w ) the covid- shock to supply chains. the university of melbourne pandemics depress the economy gianluca public health interventions and economic growth: revisiting the spanish flu evidence. ssrn comparison of the icu beds saturation rate with the capacity before and after the covid- note: the red line coincides with the total saturation of the icu capacity ( %) in the region considered. the x-axis reports the saturation rate = %; = %; = %. source: personal elaboration of data provided by minsitero della salute and protezione civile ( ) source: data provided by ministry of health technology intervention gradient and case fatality rate (panel a), confirmation rate (panel b), daily number of reported deaths (panel c) . patients become asymptomatic due to symptoms resolution . patient is negative to sars-cov- test clearance . rna and sars-cov- absence in body fluids for patient that presented symptoms and for those who did not present any symptoms . for asymptomatic patients that resulted positive, the test should not be repeated before days after the first positive diagnosis . two molecular tests need to be performed in hours. both of them have to be negative http://www.salute.gov.it/portale/nuovocoronaviru s/dettaglionotizienuovocoronavirus.jsp?lingua=i taliano&menu=notizie&p=dalministero&id= key: cord- -vcys q t authors: kawachi, ichiro title: covid- and the ‘rediscovery’ of health inequities date: - - journal: int j epidemiol doi: . /ije/dyaa sha: doc_id: cord_uid: vcys q t nan in the wake of the brutal police killing of george floyd in minneapolis on may , cities and counties across the usa came out to declare that racism is a 'public health emergency'. needless to point out, systemic racism has existed for over years in america. the crisis sparked by george floyd's murder illustrates the point that it takes a shock to the system to bring about broader acknowledgment of the daily realities lived by a whole segment of the population. indeed, ignorance of the existence of systemic racism (a.k.a. white privilege) is what enables stark inequalities to fester. likewise, health inequalities have been evident since the beginning of public record keeping-q.v. villermé's tabulations of mortality rates by income ( - ). the covid- pandemic just happens to be latest crisis that has brought renewed attention to the existence of health inequalities. throughout history, people's experiences of pandemics have differed according to their access to power, privilege and resources. in th century plague-stricken florence, wealthy patricians fled the city to their secluded villas in the tuscan hills, where they amused themselves in the evenings by drinking fine wine and recounting stories to each other. unfortunately, there are few surviving records of the suffering of those left behind in the city, as the majority of the population was illiterate. a future historian writing about the covid- pandemic will note the dramatically different ways in which people experienced the pandemic according to their race, social class, gender and immigrant status. it is as if people inhabited alternate realities. the historian will note how high-speed internet and zoom enabled the comfortably well off to escape crowded urban centres and wait out the pandemic in their second homes in the countryside, while silicon valley billionaires at the apex of the economic pyramid fled on their private jets to their bunker-equipped estates on waiheke island, new zealand. meantime, for millions of others, the stark reality of life under covid consisted of losing their jobs, falling behind on the rent and ending up either evicted or doubling up with other family members, thereby piling on their risk of infection. pandemics disrupt everybody's lives, but not in the same way. a basic tenet of social epidemiology is that the probabilities of exposure and outcomes (conditional on exposure) are not random, but socially patterned. almost always the odds are stacked against the socio-economically disadvantaged. consider the case of other major disasters. media stories often portray these events (earthquakes, hurricanes or the sinking of the titanic) as if they were random acts of god in which everyone, rich and poor alike, are vulnerable. this is seldom the case. the social epidemiology of disaster shows that socio-economically disadvantaged groups are both more likely to be exposed to disaster (because they live in disaster-prone areas or live in structurally unsound houses) and more likely to suffer the consequences of exposure (because they suffer disproportionately from preexisting morbidity, making them vulnerable to problems such as the interruption of services that follow inevitably in the wake of disaster). by the time covid- has run its course in - years, we should not be surprised if the toll of infection and mortality turn out to be the highest in the most unequal societies in the world-the usa, brazil, india, russia, and among african countries, south africa. the usa is a textbook case of longstanding inequalities in income, working conditions and access to healthcare, leaving large swaths of the population vulnerable to the effects of crises. persistent segregation of the workforce by race/ethnicity all but ensured that coronavirus infection would be concentrated in communities of colour. black americans are over-represented in jobs involving close contact with people, including in the health care support sector (nursing and home aides), personal care and service (e.g. barbers, hair salons) and food preparation/serving occupations. in turn, higher risk of exposure in the workplace is compounded by the persistent residential segregation of neighbourhoods, where unequal exposure to air pollution (see also the analysis of the uk biobank data by chadeau-hyam et al. featured in this issue) and overcrowded housing conditions amplify the spread of infection. besides residential neighborhoods and workplaces, some of the biggest outbreaks have been recorded in prisons, where some . million americans are incarcerated, half of whom are black or hispanic. in short, it was predictable that the devastating toll of covid- would be starkly patterned by race, social class and geography. landing like a hurricane, the coronavirus tore the cover off decades of disinvestment and neglect of communities of colour. wearing masks can only go so far in protecting vulnerable members of society. compounding the misery of covid- morbidity and mortality, the public health response to the pandemic has come at the cost of a sharp global economic contraction. an unfortunate (but all too predictable) consequence of 'bending the infectious curve' is that business and school closures, as well as directives to shelter in place, disproportionately afflict the already disadvantaged. small business closures in the usa have hit black-owned businesses the hardest, because a higher share of them are in the restaurant, personal services and retail sector. many of these businesses may never come back. during economic contractions that accompany pandemics, workers with the least skills and lowest pay are usually the first to be let go. but we have always known this. writing about the great plague of london in , daniel defoe remarked: 'all families retrenched their living as much as possible, as well those that fled as those that stayed; so that an innumerable multitude of footmen, serving-men, shopkeepers, journeymen, merchants' bookkeepers, and such sort of people, and especially poor maid-servants, were turned off, and left friendless and helpless, without employment and without habitation, and this was really a dismal article.' (p. ) some londoners might have considered themselves even lucky to have escaped with just being out of work. others who were less fortunate were pressed into compulsory service as watchmen to guard over 'infected houses' to make sure that people in them did not break quarantine rules, or forcibly put to work by parishes as 'searchers'generally 'women of honest reputation, and of the best sort as can be got'-whose job it was to search for dead bodies. when the haves and have nots inhabit separate worlds and experience divergent realities, it hamstrings society's ability to mount a coherent response to a common threat. it is characteristic of a divided society that people question the need for universal public health measures. they ask: 'why am i being asked to shelter in place, when i don't see a problem in my community?' a society lacking the social basis of solidarity means that slogans such as 'together we can beat the virus' fail to mobilize unified action. the problem is compounded (as in the usa) when the policy response is devolved to each locality-states, cities and counties-resulting in a patchwork of directives that are inconsistently enforced. in many localities it is left to each individual's choice to decide whether to comply with recommendations such as wearing masks or practicing social distancing. it does not help that politicians have exploited existing fracture lines by encouraging their supporters to flout public health advice as an expression of fealty. 'lockdown fatigue' is cited as the reason why governors in several us states are rushing to reopen businesses despite rising caseloads. their rallying call is that the cure cannot be worse than the disease. but the voices of frontline workers are being drowned out by the clamour of business owners to reopen. when employers call them back to work, workers are being thrust into the position of choosing whether to stay at home (and lose their unemployment benefits), or to return to work and risk losing their health. the 'frontline' is a metaphor borrowed from war, and echoes past conflicts when young men lacking the wherewithal to defer the military draft were dispatched to the frontlines. in the context of the pandemic, 'essential' workers are being sent back to work in order to resuscitate the economy (and to improve the re-election chances of incumbent politicians). in the usa, frontline workers are even being equated with 'warriors' (as when president trump declared during a visit to a face mask factory in arizona in may , 'the people of our country should think of themselves as warriors. our country has to open.'). meanwhile, far away from the frontlines, conversations about when businesses should reopen seemingly revolve around an entirely different set of concerns, such as how long one can go without a haircut. for those with the ability to work remotely, the pandemic might even produce a tiny health dividend. for them, tele-work has resulted in less commuting stress, more discretionary time to engage in daily physical activity (as evidenced by booming sales of stationary exercise bikes) and more home cooked meals. (needless to add, these theoretical benefits apply mainly to families who do not have young children at home.) when future historians look back on the dismal performance of unequal societies during the covid- pandemic, they will conclude that their leaders were too slow to implement public health measures, and too hasty in loosening them. a polarized society in which those who feel protected from the virus do not share the same lived reality as the vulnerable is a recipe for flawed decision making. a health equity framework is needed to guide debates about how societies should respond to the ongoing covid- crisis. yet the information systems upon which we base our forecasting models are sorely lacking in socio-economic data. electronic health records in the usa omit information such as occupation, educational attainment and household income, resulting in the resort to imperfect proxies such as medicaid status or neighbourhood socioeconomic status. in turn, the absence of relevant socioeconomic data means that the current tools we use to guide decisions lack an explicit equity focus. for example, infectious disease models do not formally incorporate social inequalities in transmission dynamics and infection severity. compartmental epidemiological models, such as susceptible-infected-recovered (sir) models, typically do not factor in the influence of social determinants when estimating the transition probabilities between different states (e.g. exposed ! infected, or infected ! recovered). the r-nought is discussed in the aggregate but not broken down by race, social class or other axes of social stratification. as a result the health equity impact of policy choices are presented in qualitative terms, but never quantified. similarly, mathematical forecasting of the covid- pandemic only speaks of aggregate numbers. modelling has suggested that one in five people around the globe are at risk of severe covid infection, due to underlying conditions like diabetes, respiratory and cardiovascular disease. yet these projections are silent with regard to the social distribution of vulnerability. the reason for this lacuna is because the global burden of disease project (upon which the projections are based) is silent with regard to the social distributions of underlying diseases that elevate the risk of severe covid infection. aggregate projections stripped of their socio-economic context serve as an insufficient basis to guide momentous decisions, such as who should receive priority when a vaccine eventually becomes available. what will be the basis to debate whether a white-collar professional with pre-existing conditions (working from home) deserves higher priority access to a vaccine compared with an otherwise healthy black frontline worker? economic models are equally silent with regard to distributive effects of policy choices. cost-benefit and costutility analyses of border closures and lockdowns inform us about costs to society in the aggregate, but typically they do not consider who bears the costs of job losses and lost productivity vs loss of life and morbidity. it may turn out to be the case that lockdowns produce a net health equity gain by saving the lives of the most vulnerable segments of the workforce (especially if adequate social protections are in place to mitigate the consequences of job loss). but we cannot know the true answer unless formal modelling is undertaken to incorporate equity considerations. for example, recent quasi-experimental evidence from the national lockdown in italy showed a proportionally sharper reduction in the mobility of the less well off, suggesting that both poverty and income inequality will be exacerbated as a result. forecasting models do not set out, by design, to ignore socio-economic status; the problem is that the raw data are not being collected at source (e.g. hospital records, covid registries). epidemiologic forecasting models need to advance beyond making aggregate projections. the goal of an equity-informed forecasting exercise should be to inform decision makers about how to anticipate and mitigate the inevitable health equity consequences of policy debates about when to reopen borders, schools, workplaces and public spaces, as well as how to prioritize the global distribution of a vaccine (when it materializes). the moment seems ripe when the international epidemiological community should be calling upon hospitals, health authorities and governments to begin collecting socio-economic data. ), a pioneer in social epidemiology: re-analysis of his data on comparative mortality in paris in the early th century the decameron rich americans activate pandemic escape plans. interest in new zealand bunkers has surged. blacks in the labor force exposure to air pollution and covid- mortality in the united states: a nationwide cross-sectional study a journal of the plague year ( ). london: penguin books trump drafts everyday americans to adopt his battlefield rhetoric incorporation of socioeconomic status indicators into policies for the meaningful use of electronic health records global, regional, and national estimates of the population at increased risk of severe covid- due to underlying health conditions in : a modelling study economic evaluation of border closure for a generic severe pandemic threat using new zealand treasury methods economic and social consequences of human mobility restrictions under covid- key: cord- -d ll nv authors: patterson, joanne m; govender, roganie; roe, justin; clunie, gemma; murphy, jennifer; brady, grainne; haines, jemma; white, anna; carding, paul title: covid‐ and ent slt services, workforce and research in the uk: a discussion paper date: - - journal: int j lang commun disord doi: . / - . sha: doc_id: cord_uid: d ll nv background: the covid‐ pandemic and the uk government's subsequent coronavirus action plan have fundamentally impacted on every aspect of healthcare. one area that is severely affected is ear, nose and throat (ent)/laryngology where speech and language therapists (slts) engage in a diverse range of practice with patients with a range of conditions, including voice disorders, airway problems, and head and neck cancers (hncs). a large majority of these patients are in high‐risk categories, and many specialized clinical practices are vulnerable. in addition, workforce and research issues are challenged in both the immediate context and the future. aims: to discuss the threats and opportunities from the covid‐ pandemic for slts in ent/laryngology with specific reference to clinical practice, workforce and research leadership. methods & procedures: the relevant sections of the world health organisation's (who) health systems building blocks framework ( ) were used to structure the study. expert agreement was determined by an iterative process of multiple‐group discussions, the use of all recent relevant policy documentation, and other literature and shared documentation/writing. the final paper was verified and agreed by all authors. main contribution: the main threats to ent/laryngology slt clinical services include increased patient complexity related to covid‐ voice and airway problems, delayed hnc diagnosis, reduced access to instrumental procedures and inequitable care provision. the main clinical opportunities include the potential for new modes of service delivery and collaborations, and harnessing slt expertise in non‐instrumental assessment. there are several workforce issues, including redeployment (and impact on current services), training implications and psychological impact on staff. workforce opportunities exist for service innovation and potential extended ent/slt practice roles. research is threatened by a reduction in immediate funding calls and high competition. current research is affected by very limited access to participants and the ability to conduct face‐to‐face and instrumental assessments. however, research opportunities may result in greater collaboration, and changes in service delivery necessitate robust investigation and evaluation. a new national set of research priorities is likely to emerge. conclusions & implications: the immediate impact of the pandemic has resulted in major disruption to all aspects of clinical delivery, workforce and research for ent/laryngology slt. it is unclear when any of these areas will resume operations and whether permanent changes to clinical practice, professional remits and research priorities will follow. however, significant opportunity exists in the post‐covid era to re‐evaluate current practice, embrace opportunities and evaluate new ways of working. what this paper adds: what is already known on the subject: ent/laryngology slts manage patients with a range of conditions, including voice disorders, airway problems and hncs. the diverse scope of clinical practice involves highly specialized assessment and treatment practices in patients in high‐risk categories. a large majority of active research projects in this field are patient focused and involve instrumental assessment. the covid‐ pandemic has created both opportunities and threats for ent slt clinical services, workforce and research. what this paper adds to existing knowledge: this study provides a discussion of the threats and opportunities from the covid‐ pandemic for ent/laryngology slt with specific reference to clinical practice, workforce and research leadership. what are the potential or actual clinical implications of this work? the covid‐ pandemic has resulted in major disruption to all aspects of clinical delivery, workforce and research for ent/laryngology slt. changes to clinical practice, professional remits and research priorities are of indeterminant duration at this time, and some components could be permanent. significant clinical practice, workforce and research opportunities may exist in the post‐covid era. the uk government's coronavirus action plan to the covid- pandemic includes four stages: containment, delay, research and mitigation. the consequent legislation (the health protection regulations ) enables action in five main areas: ( ) increasing the available health and social care workforce; ( ) easing the burden on frontline staff and prioritizing care for people with the most pressing needs; ( ) containing and slowing the virus by reducing unnecessary social contacts: ( ) managing the deceased with respect and dignity; and ( ) supporting people. these measures are temporary and subject to regular review. however, consequently, the delivery of every aspect of healthcare by all clinical and non-clinical departments in the national health service (nhs) has been fundamentally affected (willan et al. ) . the royal college of speech and language therapists (rcslt) has stated that, as specialists in communication and swallowing, speech and language therapists (slts) have a crucial role to play as part of wider multidisciplinary teams (mdts) in this response (rcslt a) . this includes: ( ) supporting people with communication and swallowing needs who contract the virus; ( ) ensuring relevant information is accessible to those who have speech, language and communication needs; ( ) urging relevant retirees and graduates to increase the available health and social care workforce; and ( ) reducing risk of contracting the virus to slts, their loved ones and those they care for and work with. the nihr crn ent slt (national institute for health research clinical research network, ear nose and throat sub-specialty speech and language therapy) research group represents a collaboration of experienced clinical researchers in ent/laryngology (voice and airway disorders, and head and neck cancer-hnc). this group provides a broad geographical representation of specialist ent/laryngology clinical services in england and includes all the main researchers in the field. a large majority of this group are also at the covid- and ent slt/laryngology services, workforce and research in the uk forefront of clinician services associated with covid- nhs service delivery. ent slt services have seen major alterations during the pandemic. direct changes include a steep increase in referrals for covid- -related voice, swallowing and airway problems. indirectly, voice, airways and hnc patients have experienced less face-to-face slt contact, more remote consultations, fewer joint clinics and less access to instrumental assessments, with alterations and delays to their proposed treatment. the aim of this paper is to describe these changes and potential consequences in more detail, and to discuss the threats and opportunities from the covid- pandemic for slts in ent/laryngology practice. this discussion paper represents the consensus view of the nihr crn ent slt research group (see the acknowledgements). a series of discussions has been distilled by the authors and verified by the whole group before publication. we have used the world health organisation's (who) health systems building-blocks framework (who ) to select those relevant to this discussion, namely: service delivery (clinical consideration), workforce and leadership/governance (research implications). the expert consensus of the current context and the future implications and opportunities are discussed for each of these three areas. ent slts engage in a diverse scope of clinical practice with many working within highly specialized mdts. these teams serve patients with a range of conditions including hncs, benign voice disorders and airway problems. many of these patients fall into the 'vulnerable' category, in particular those with a laryngectomy or long-term tracheostomy, who have an increased risk of pneumonia (el cheikh et al. ) . the pandemic presents new clinical challenges for the foreseeable future with . % of respondents in a recent rcslt survey stating that the pandemic was having an impact on their professional roles, responsibilities and duties (rcslt b). here we summarize the impact of covid- on: ( ) existing ent slt services and service delivery, before highlighting clinical considerations, adaptations and potentially new clinical opportunities for each of three main patient groups within this sphere of practice: ( ) hnc services, ( ) voice services and ( ) airways services. under usual circumstances professional guidelines advise that all patients with suspected laryngeal disorders should undergo endoscopic evaluation of the larynx (eel) (rcslt ). similarly, endoscopic or videofluoroscopic evaluations of swallowing are key diagnostic and therapeutic techniques. these specialized services have been disrupted by the pandemic with prioritization of resources, rigorous risk criteria and new protocols being introduced to limit virus transmission (rcslt c (rcslt , d . this cessation of routine nasendoscopic procedures impacts patient care with the potential for misdiagnosis, suboptimum treatment and unnecessary healthcare utilization (idrees and fitzgerald ) . in the absence of endoscopy ent slts are using their clinical skills for the benefit of patients. ent slts can assess and manage patients using detailed and thorough history-taking, perceptual and acoustic evaluation of voice and comprehensive clinical assessment of swallowing. they are also able to use their work with patients to prioritize those who do need further instrumental evaluation. routine, face-to-face slt outpatient appointments have been postponed indefinitely to limit unnecessary footfall in hospitals with % of slts reporting that there are patients on their caseload no longer receiving intervention when they would usually do so (rcslt b). many slt procedures, including dysphagia assessment, have been designated high-risk aerosol generating procedures (agps) in the rcslt professional guidelines and evidence review (bolton et al. ) . this means that emergency cases such as urgent laryngectomy voice prosthesis changes require ent slts to follow rigorous infection control guidance and wear full personal protective equipment (ppe). innovative approaches to continuing and reestablishing clinical practice are being trialled and implemented. over % of slts surveyed have identified changes made as a result of the pandemic that are of benefit to their clinical practice, patients and/or service (rcslt b). this has included setting up telehealth services to offer assessment and rehabilitation via telephone and video-conferencing reviews. this has benefits to patients with previous research showing favourable clinical outcomes and good acceptance (burns et al. ) . the potential for aspects of telehealth practice to be incorporated within the ent slt pathway beyond the pandemic is already part of the conversations amongst many teams. another challenge with the interruption in outpatient ent slts has been the reduction in mdt clinics. close liaison with surgical, allied health and nursing colleagues is crucial to form a clear, well-evidenced treatment plan for ent patients. limitations to faceto-face mdt contacts have been overcome using telehealth and forward planning for services to reopen in the most efficient, safe and effective way possible for patients. for ent slts there are very real concerns that the current climate means that people are delaying general practitioner and accident and emergency (a&e) visits with health concerns (nhs england news ). if patients present with later stage (more advanced) disease, they will require more intensive treatment, and by extension, greater slt rehabilitation needs. undiagnosed laryngeal disorders might worsen over time, increasing their complexity and hindering treatment response (stachler et al. ) . ent slts also need to be vigilant of the high prevalence of laryngeal injury post-extubation in intensive care unit (icu) settings, which can cause dysphonia and/or dysphagia (brodsky et al. ) laryngeal trauma might also arise from acute cough (slinger et al. ) , with post-viral symptoms impacting voice and swallowing even in patients who have not been admitted to hospital. this leads to the potential for a surge of new referrals for ent slts as the initial peak of the pandemic passes and needs to be accounted for in service delivery. in the uk nhs, hnc is managed by mdts working within cancer centres, with the slt being a core mdt member (national institute for health and clinical excellence ). as such, slts are involved at every stage of an individual's care from diagnosis and pre-habilitation throughout oncological treatment, post-treatment rehabilitation, survivorship and palliation. the current pandemic has triggered a range of changes to many aspects of the hitherto relatively wellestablished head and neck patient pathway. most suspected cancer referrals are received via the -week wait referral pathway (department of health ) via general practitioners or dentists, or through a&e departments. this referral rate has significantly reduced due to public fears in accessing healthcare. for referrals that are received via a -week wait referral pathway, hospital consultants are using telephone consultations. without the benefit of face-to-face clinical examination, alternate innovations that enhance differential diagnosis is vital. one such innovation is the use of a remote evidence-based triage system (paleri et al. ) to stratify patients according to likely risk of cancer. patients with voice and swallowing symptoms, which are least likely to be attributable to a cancer diagnosis, could potentially be directed toward slt-led clinics (see voice services below). weekly mdt meetings are a feature of all cancer centres in the uk and are the focal point for discussion and decision-making around each patient's individual treatment plan. these meetings are now either severely reduced or conducted virtually. slt input around functional outcome in relation to different treatment options is compromised. instead, discussions are often abridged with a focus on which patients require urgent treatment, who can be delayed and how to best provide oncological treatment with least risk to patients and staff. relevant professional bodies have issued guidance and collaborative statements around management of hnc patients during the pandemic (ent-uk ), which temporarily replace existing guidelines (national institute for health and clinical excellence ). slts may experience loss of professional identity within the mdt, but more importantly delays to clinical input, decision-making as well as losing the benefit of joint working may have negative consequences for patients. patients may encounter mixed messages from the team that can add confusion and anxiety to an already stressful event of receiving a cancer diagnosis. this may escalate into negative consequences for building trust with the team and could potentially influence patient engagement and subsequent outcomes. the surgical and chemo/radiotherapy treatment regimes for hnc have been adjusted in response to the risks associated with coronavirus transmission (day et al. ) . accordingly, the british association of head and neck oncologists (bahno) have issued treatment decision guidance during the pandemic (bahno ). they recommend avoidance of laryngectomy procedures unless considered absolutely necessary and to treat with radiotherapy instead. however, voice and swallowing can be adversely affected in patients with advanced laryngo-pharyngeal cancer treated with radiotherapy (rosenthal et al. ) . furthermore, treating residual or recurrent disease with salvage laryngectomy can lead to poorer voice and swallowing outcome (burnip et al. ) . where primary laryngectomy is performed, tracheoesophageal puncture (tep) should be avoided to reduce the risk of early postoperative complications. although a secondary tep can be performed later, slts will need to prepare and rehabilitate patients using non-surgical voice-restoration covid- and ent slt/laryngology services, workforce and research in the uk methods. access to appropriate communication aids such as electrolarynx devices is therefore imperative. bahno has also advised limiting operation times wherever possible, for example, use of local flaps instead of free flaps. minimally invasive surgery is currently not accessible (day et al. ). this has implications for functional outcome. for some, superior speech and swallowing can be achieved with local flaps, where structures are mobile and tethering is limited (lam and samman ) . however, large defects insufficiently reconstructed can result in sumps and reduced proximity of anatomical structures, affecting articulation accuracy and pressure generation for efficient and safe swallowing (lam and samman ) . furthermore, bahno have advised restricting the use of chemoradiotherapy, and treating solely with radiotherapy, wherever possible. this alteration to traditional treatment regimes may result in superior outcomes for swallowing as single modality treatments tend to be less deleterious for functional outcomes (wilson et al. ) . these adaptations to treatment have implications for the pretreatment discussions slts have with patients and their expectations for their subsequent function and rehabilitation. it is also important to highlight that changes in treatment regimes during the pandemic mean that many patients will not receive the optimum treatment plan they may have otherwise been offered. the emotional and psychological response that individuals may have to this cannot be underestimated and may be an important area for further research. clinicians have had to be innovative in managing their hnc outpatient caseloads. whilst there is likely to be much variation throughout the country, it is encouraging to note that large numbers slt services have proactively adapted to provide rehabilitation via telephone ( . %) and video-conferencing ( . %) while promoting self-management where possible (rcslt b). however, not all patients are suitable or indeed receptive to telehealth, and the ramifications of delaying rehabilitation will need to be carefully considered as we move through the pandemic and decide on priorities for restarting face-to-face services. rcslt clinical excellence networks (cens) have played an important part in disseminating and sharing experiences via social media and through the cen websites. patient organizations such as the national association of laryngectomy clubs and the swallows charity amongst others have also played an important supportive role for both patients and carers alike. referral patterns to voice and upper airway services will depend upon the activity of existing referral sources who may be seeing fewer patients, in conjunction with anticipated increased demands from covid- patients. new referral sources might include respiratory medicine and intubation trauma services. notably, the newly proposed remote evidence-based triage system described above (paleri et al. ) could further increase referrals for slt-led eel clinics. an ent sltled two week wait hnc referral pathway for low risk hoarse patients pilot study demonstrated an excellent safety record for cancer screening and more efficient access to voice services (slade and mcglashan ) . this role extension requires clear protocols, parallel consultant ent input and trust-level clinical governance clearance. delays to elective phonosurgery, including injection laryngoplasty, may also demand intermediate voice therapy and/or provision of amplification devices (white ) . postponement of such treatments could have huge psychosocial implications for patients, particularly those who are socially isolating, as telephone use is a common challenge for individuals with dysphonia. post-extubation injuries can include laryngeal oedema, arytenoid dislocation, laryngeal ulceration and vocal cord paralysis (brodsky et al. , mcgrath et al. . notably, intubation can cause superficial mucosal damage and stiffness, affecting vocal fold pliability required for voicing (hirano and kakita ) . implications of such disorders can pose short-and long-term challenges to communication, at a time when speaking with loved ones and healthcare professionals is essential for well-being and enabling joint decision-making to promote patient-centred care. for those diagnosed with mild to moderate covid- , % reported dysphonia, and was more common in females and smokers (lechien et al. ) . time to recovery is as yet unreported. hyperfunctional voice/laryngeal disorders might also present secondary to proliferate use of telecommunications for work and social interaction, speaking through ppe and/or through increased levels of anxiety (besser et al. ) . a 'vicious cycle' may arise between anxieties and laryngeal function, particularly if laryngeal symptoms, pertinently breathlessness and cough, are interpreted as manifestations of covid- or underlying disease progression. this might be particularly challenging for those with comorbid progressive respiratory disease, for example, chronic obstructive pulmonary disease (copd). psychosocially, symptoms of chronic cough may receive negative attention thus affecting well-being. slts might also see a rise in psychogenic voice disorders. these could feasibly arise in response to direct covid- experiences; or because of difficulties dealing with uncertainties of covid- which are likely affecting all aspects of life. conversely, it is feasible that lockdown restrictions will positively influence laryngeal function for existing patients who developed dysphonia through high occupational vocal demands, owing to opportunities for voice rest if unable to attend work. for such patients, social and occupational restrictions may also provide opportunity to engage more actively in rehabilitation programmes. face-to-face therapy delivery is the cornerstone of the evidence for dysphonia treatment. routine out-patient treatment programmes are unlikely to be an option for some time and as has been previously stated adaptations towards telehealth practice are inevitable. perceptual assessment as a response to treatment trials is an essential tool yet is challenging in a virtual delivery mode. the quality and type of microphone are key for detailed capture of voice, and laryngeal function (ward et al. ). an acoustic speech processor may be useful for measures of loudness, pitch and duration data (weidner and lowman ); and controlling noise and microphone position can reduce random error (jannetts et al. ). perceptual evaluation of upper body tension, through video-consultation may also enhance treatment. distinct telehealth challenges may arise for patients with moderate to severe dysphonia, notably those with breathiness and asthenia. patients with airway issues have been recommended to shield themselves, similarly to other vulnerable groups (public health england ). complex airway patients are likely to be more susceptible to serious illness and negative consequences of treatment if they are infected with covid- . the clinical rationale for this is threefold. first, patients who have undergone airway reconstruction procedures such as laryngotracheal reconstruction (ltr) or cricotracheal resection (ctr) are high risk and challenging to intubate (crawley and dalton ) . second, prolonged ventilation of patients with an altered airway is likely to lead to worse longterm outcomes (e.g., further airway damage). third, patients with complex airway disorders often experience difficulties with cough strength and secretion clearance (tanner et al. ) . rigorous triage is now necessary to identify the highest risk patients for urgent procedures. before covid- , endoscopy and videofluoroscopy were key adjuncts in the voice and swallowing management of airways patients (clunie et al. ) . however, the loss of instrumentation is an opportunity to showcase the range of skills slts use to evaluate and treat swallowing and voice difficulties with airways patients, as well as continuing to work closely with the broader mdt to form a clear, well-evidenced treatment plan for complex airway patients. however, extended waiting lists and subsequent increased patient anxiety because of treatment delays is inevitable. attendance at highly specialist airway service clinics frequently involve expensive, long-distance travel, which can be burdensome for people requiring specialist medical care. telehealth is an opportunity to relieve this burden for complex airway patients. similar to the extended ent slt roles described above, there is also an opportunity for developing slt-led surveillance clinics for complex airway patients. these allow ent slts to use their skills to monitor swallowing, voice and airway problems remotely, and triage patients to ent, nursing and psychology colleagues as required. this also has benefits for patients as there is no unnecessary repetition within their care pathway. clinical consensus indicates that covid- has the potential to cause airway damage as a result of laryngeal manifestations of the disease (tysome and bhutta ); as well as expected long-term airway damage due to prolonged intubation and need for tracheostomy (brodsky et al. ) . as a result, airway services may see an increase in referrals in the coming months as a direct result of the virus itself. this is in addition to the number of existing patients whose treatment has been delayed in the initial response to the pandemic. airways slts will need to prepare for this potential increase with forward workforce planning and upskilling colleagues to assist with management of patients where appropriate. a summary of the main threats and opportunities for ent slt clinical services is provided in table . redeployment of staff, capacity issues related to covid- staff sickness and increased demand with new and emerging caseloads at a time of national emergency. the recent interim nhs people plan (nhs improvement ) recognizes that slts have broad ranging skills, deliver high-quality care, limit unnecessary care costs and are key in reducing reliance on hospitals. such workforce profiling and analysis suggests that the slt workforce is therefore well positioned to develop and implement new strategies to deliver care during and after the covid- pandemic. indeed, slts have already rapidly adapted to the changing covid- healthcare landscape which has mandated a shift in healthcare provision such as the shift towards telehealth solutions described above. as part of the national effort to manage covid- , the chief allied health professionals in the uk, health and care professions council (hcpc), council of deans and allied health professions council have asked practitioners to be flexible and adopt new ways of working (nhs england ). to facilitate practitioners in the transition of potential new roles the governing bodies further specify provider organizations must be supportive of new ways of working. such changes in working will be a departure from usual slt practice, but despite this, slts are urged to follow principles of best practice, following hcpc guidance, and to use professional judgement to assess risk. as well as existing staff, there has been a call to former healthcare practitioners to return to the frontline workforce with expedited hcpc and rcslt re-registration processes in place. students in advanced stages of their studies are also being offered an opportunity to join a temporary covid- register (rcslt a). the rcslt has fully supported the redeployment of slts to support the health and social care system (rc-slt a). however, services need to continue to support existing caseloads and new patients requiring input for communication and swallowing impairments. any plans for the redeployment of slts must take account of prioritized services, that is, those that cannot be suspended due to the high risks involved if they did not continue. slts can play a key role in the prevention of hospital admissions and readmissions for vulnerable groups in the community. further, slts assist in expediting inpatient discharge. such contributions support the government's plan to shield the high risk and support wider risk groups (rcslt a). the rcslt has also highlighted the key skills and expertise which slts have to meet some of the clinical presentation needs of patients with covid- (rcslt a). slts in many centres are being redeployed, for example, to icus in 'buddy' roles to support nursing and medical staff managing acutely ill covid- patients. in addition to increased capacity, buddies are being used to support pressures on service provision due to increased covid and non-covid-related staff sickness. the ability to undertake new roles should be underpinned by access to appropriate training to prepare individuals (rcslt a), and potentially the opportunity to be upskilled to allow for continued professional development. it is also emerging that those recovering from covid- are requiring the specialist skills of slts post-covid- infection. in the icu setting, if the patient is intubated but awake, the slt can support communication including consent regarding treatment decisions using alternative and augmentative communication options. when patients are extubated and moving to intermediate-level care, the slt has an essential role in the supporting communication, swallowing and airway management (rcslt a). for patients who are receiving end-of-life care, slts can play a key role in advocacy and supporting quality-of-life-focused decisions with regards to eating and drinking. finally, slts can support the consent process for recruitment to local and national covid- clinical research trials. at a time of heightened pressure on slts, consideration needs to be given to covid- and non-covid- related health burden. given the rapid pace of change in the healthcare landscape, usual consultation processes with staff are not possible. the rcslt has provided a rapid response in producing guidance for the profession, including safety indications for ppe and aerosolgenerating procedures, applicable to ent slts (bolton et al. ) . given the uncertainty and anxieties that staff may experience, nhs employers ( ) have set out guidance for leaders highlighting the importance of regular and open communication. as well as physical health, increased efforts have been made to address mental health proactively with guidance for managers and several services being offered by companies for free, for example, big health, headspace and unmind (british psychological society ). the future remains uncertain, with the potential for further covid- case surges. however, healthcare providers are already considering post-covid- service recovery and response plans. healthcare organizations will need to recognize new models of good practice. as a part of this, workforce issues will be a critical element for consideration. there may be shifts from acute to community provision of services. similarly, the rapid transition from traditional, face-to-face clinical service delivery to telehealth as described above may well become embedded. however, some services may not have adequate video-conferencing resources and expertise, delaying access and increasing inequalities in service provision. likewise, the increased use of information technology (it) and virtual platforms for meetings and sharing resources may facilitate ongoing collaborative links across large geographical areas with minimal travel or venue hire costs. this may mean slts working remotely and making use of it solutions which have been rolled out to facilitate this. there is now a staged return to slt-led endoscopy services (rcslt d). consideration will be needed for compliance with these guidelines and how this affects current caseloads, regardless of covid status. this will be particularly challenging for training new slt endoscopists. extended practice roles such as triage systems and ent slt-led two week wait clinics will require further training, greater numbers of specialist skilled staff and equipment resources. the main threats and opportunities related to ent/slt workforce are summarized in table . leadership nihr crn ent slt group members have expertise in generating, implementing and disseminating evidence-based practice while remaining patient facing. they have extensive clinical research networks to ensure that their contributions to strategic direction on issues affecting ent slt delivery of care. the group has a shared focus and provides a forum for collective learning, innovation and research prioritization. it works across geographical and service boundaries and is driving high-quality research that is clinically relevant and implementable across services. as described above, clinical issues and service delivery have altered at a fast pace, with little time to evaluate the evidence for such changes. this period of instability and change in priority-focus requires a rethink of the ent slt collective research strategy. the ent slt research profile across the uk has several multidisciplinary, multi-and single-centre studies open to recruitment and follow-up (e.g., pathos cruk/ / cpms ; dars cruk/ / cpms ; pitstop cpms ) supported by the nihr portfolio. in addition, there are many studies led by ent slts, funded by the nihr the pandemic has slowed the progress of research into non-covid- topics, created major disruption for ent slt-related studies and arrested nihr clinical fellowships. common methodologies and methods used in ent slt research have been challenged and will continue to be in the post-covid era. for example, studies conducting instrumental tests are now severely restricted and their reintroduction into clinical, let alone research, practice is unclear, but likely to be slow. furthermore, slt research is frequently 'patient-facing' and multidisciplinary. commonly used methods such as focus groups and co-design, with face-to-face contact for non-essential activities, and in particular group gatherings will be restricted for some time. again, these activities may continue via telephone or video-conferencing, while recognizing potential exclusion of those unable or unwilling to access it. access to vulnerable patient groups, for example, older adults, people with a laryngectomy or tracheostomy will be further limited for an extended, undefined period of time. conducting patient and public involvement events to establish research priorities and collaboration will be challenging. furthermore, opportunities to disseminate research have reduced, with cancellation of interna-tional and national face-to-face meetings although some have transferred to virtual conference platforms. many uk research councils are redirecting or repurposing funding to enable new treatments, diagnostics and vaccines to contribute to the understanding of, and response to, the covid- pandemic and its impacts (uk research and innovation ). the nihr have now opened a funding call for research into covid- pandemic beyond the acute phase (nihr b). charitable research funders have experienced significant downturn in their income necessitating an immediate cut in research spending. for example, cancer research uk (cruk) predict this will set back the uk cancer research programme, potentially for many years, and are postponing funding decisions for the majority of . rcslt clinical excellence networks and the nihr crn ent slt research group have been essential to information dissemination, best practice and problemsolving. agreement on prospective data collection to evaluate altered service models is an imperative. limited learning will occur if this work is conducted uniprofessionally, in silos with small single-centre data collection. national databases have been set up, including the rcslt covid- and head and neck oncology cen laryngectomy data set, ent-uk national covid- tracheostomy service evaluation to investigate voice and swallowing outcomes and changes to service provision. now more than ever, there is a need to upskill to generate and evaluate the best evidence to respond to this changed landscape. the nihr recognizes the importance of maintaining a research pipeline and their funding and training schemes will remain open, with some changes to application deadlines the nihr crn ent slt group have met to discuss research priorities for clinical considerations and service delivery. examples of these priorities include: table • reduction in funding calls and high competition • current research affected by access to participants and ability to conduct face-to-face and instrumental assessments • greater collaboration across ent slt group • changes in service delivery warranting further investigation • generation of national databases • new set of research priorities • understanding post-extubation laryngeal trauma, its impact, trajectory for recovery and management of associated voice and swallowing problems. • identifying risk factors for dysphagia following tracheostomy placement and effective dysphagia rehabilitation. • understanding the respiratory-swallow cycle, cough and laryngeal function in patients with acute and chronic respiratory disease. • reliability and validity of non-invasive voice and swallowing screening and assessment tools, including those that can be conducted remotely. • collection of standardized outcome measures, using digital technologies where possible. • impact of altered hnc treatment schedules on functional outcome. service delivery and models of care need evaluation and further development as to how we can best support patients, the workforce and the nhs as a whole. examples of priorities include: • provision of remote highly specialist care for our most vulnerable patients. • extent of agp for routine ent slt procedures and how they are best managed. • models of telehealth for ent slt services. • implementation of ent slt-led clinics and triaging. • the main threats and opportunities to ent/slt research are summarized in table . the aim of this paper was to provide an expert discussion on the threats and opportunities from the covid- pandemic for slts in ent/laryngology practice. the nihr crn ent slt research group represents a collaboration of experienced clinical researchers in ent/laryngology with a broad geographical representation across england. it is clear that the covid- pandemic has had and will continue to have a significant impact on all aspects of slt practice and research in ent/laryngology (hnc, voice and airway disorders). the implications of the current situation with respect to the ent/laryngology clinical area are significant, but with recognition of there is considerable overlap with slt services in respiratory care, critical care and dysphagia care generally. it is also recognized that there are several major issues that require evaluation for the whole of the nhs workforce (e.g., ppe provision and mental health and well-being) (sayburn , unadkat and farquhar ) . whilst these issues are highly relevant to many slts, the issues are not profession specific and consequently mentioned only briefly here. it is evident that the immediate impact of the pandemic has resulted in major disruption to all aspects of clinical delivery, workforce and research. it remains unclear as to when any of these areas will resume operations and if the post-covid era will have changed clinical practice, professional remits and research priorities forever. clearly a significant opportunity exists in the post-covid era to re-evaluate current practice, embrace and evaluate new ways of working, requiring strategic planning, coordination, collaboration, and dissemination across the uk. psychological stress and vocal symptoms among university professors in israel: implications of the shift to 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reconsidering traditional treatment paradigms in light of new surgical and other multilevel risks microbiology of tracheal secretions: what to expect with children and adolescents with tracheostomies coronavirus disease (covid- ) covid- guidance for nhs workforce leaders covid- guidelines cover-body theory of vocal fold vibration vocal cord dysfunction in bronchial asthma. a review article assessing voice health using smartphones: bias and random error of acoustic voice parameters captured by different smartphone types speech and swallowing following tongue cancer surgery and free flap reconstruction-a systematic review features of mild-to-moderate covid- patients with dysphonia laryngeal oedema associated with covid- complicating airway management mhra guidance on coronavirus (covid- ) nhs health research agency (hra) covid- improving outcomes in head and neck cancers rapid implementation of an evidencebased remote triaging system for assessment of suspected referrals and patients with head and neck cancer on follow-up after treatment during the covid- pandemic: model for international collaboration covid- : guidance on shielding and protecting people defined on medical grounds as extremely vulnerable long-term outcomes after surgical or nonsurgical initial therapy for patients with t squamous cell carcinoma of the larynx: a -decade survey covid- : maximising the contribution of the speech and language therapy workforce impact of the covid- pandemic on the speech and language therapy profession speech and language therapist-led endoscopic procedures in the covid- pandemic are uk doctors getting sufficient protective equipment against covid- ? can speech and language therapists manage hoarse voice patients on the two week wait head and neck cancer referral pathway? speech and language therapy for management of chronic cough clinical practice guideline: hoarseness (dysphonia) (update). otolaryngology-head and neck surgery nebulizer use in adults with subglottic stenosis: a survey study the health protection (coronavirus) regulations covid- : protecting our ent workforce self-care for doctors during the covid- crisis impact of dysphagia severity on clinical decision making via telerehabilitation telepractice for adult speechlanguage pathology services: a systematic review management of benign vocal fold lesions: current perspectives on the role for voice therapy. current opinion in otolaryngology head and neck surgery everybody's business: strengthening health systems to improve health outcomes: who's framework for action. world health organization challenges for nhs hospitals during covid- epidemic dysphagia after nonsurgical head and neck cancer treatment: patients' perspectives in addition to the listed authors, all members of the nihr crn ent slt (national institute for health research clinical research network, ear nose and throat sub-specialty speech and language therapy) contributed to discussions related to clinical service issues and research priorities informing this paper and include dr margaret coffey, dr camilla dawson, dr anne hurren, ms abigail miller, ms sarah stephen, ms mandeep bhabra and ms laura-jayne watson. declaration of interest: all authors of this paper are part of the nihr crn ent slt research group, which is a collaboration of experienced clinical researchers in ent/laryngology (voice and airway disorders, and head and neck cancer). a large majority of this group are also at the forefront of clinician services associated with covid- nhs service delivery. key: cord- - nec lj authors: otugo, onyeka; wages, brooke title: covid- : the additional sentence for the incarcerated date: - - journal: health equity doi: . /heq. . sha: doc_id: cord_uid: nec lj incarcerated people are one of the most vulnerable populations during the coronavirus pandemic. there are varying perspectives regarding how to address the health care barriers seen in this population. some individuals and organizations advocate for a mandatory release of the incarcerated who are not deemed a risk to the general population, whereas others advocate for improving health care in jails and prisons. this article highlights the importance of addressing access to care issues, overcrowding, societal implications, and access to hygienics for the incarcerated during the coronavirus disease pandemic, and solutions forward. the united states has the highest rate of incarceration in the world with one of the most expansive criminal justice systems in modern history. approximately . million people are incarcerated, not taking into account those in juvenile detention, on home monitoring devices, or on probation. in all, there are * million individuals belonging to the united states criminal justice system. incarceration disproportionately impacts minority populations in addition to those with mental health disorders. compounding these issues are the unmet health care needs of this population. those who are incarcerated have a disproportionate burden of diseases such as mental health illnesses, hiv/aids, substance use disorders, and chronic conditions such as diabetes and hypertension. , this disproportionate burden results in poor health outcomes. on various prisons and jails have reported the spread of covid- among their populations. it is not news that many prisons are overpopulated, creating the perfect breeding ground for infectious disease transmission leading to outbreaks. the lack of effective health care is a result of poorly resourced facilities and structural racism resulting in a disproportionate number of african americans and hispanics who are incarcerated. , simply stated, our health care system is failing this vulnerable population. with the growing number of those infected with covid- , these issues will only further be exaggerated. incarceration presents significant disparities regarding health equity. reentry after incarceration in the united states is a broken process, which is further intensified in the midst of a pandemic. communicable diseases pose serious risks to those in correctional facilities given the intimate confines, lack of access to adequate sanitation methods, and barriers to equitable health care. diseases such as tuberculosis, hepatitis c, and hiv/aids are more common in correctional facilities. , new york governor andrew cuomo promoted an initiative to generate > , gallons of hand sanitizer weekly produced by inmates. these individuals are producing the same hand sanitizer that is not made available to them for use in most prison facilities given their high alcohol content. in addition, it is not uncommon to find sinks that do not work or are not easily accessible and a lack of soap in prisons. given that overcrowding and poor sanitation are vehicles to promote disease transmission, this population is left further exposed. an additional barrier to care is the copay requirement in certain state prisons and jails act as an additional barrier to care. even though prisons provide health services, they can come with the cost of a copay. california and illinois have taken steps forward by eliminating copay for the incarcerated, and others should follow. there are different schools of thought regarding what to do with the incarcerated population. given the inadequate health care delivery system for the incarcerated, some view keeping the incarcerated in prisons and jails during the covid- pandemic as an extension of their existing sentence. a proposed solution is the reduction of incarcerated people in jails and prisons to prevent the spread of covid- . thousands of people have been released from correctional facilities in the past several weeks to mitigate the spread of covid- . recently, the committee for public counsel services and the massachusetts association of criminal defense lawyers filed an emergency petition that calls for the reduction of the number of incarcerated individuals through limiting those who will be taken into custody and releasing those who would be considered high risk for contracting covid- , those toward the end of their sentence, and those who do not pose a significant risk to the general population. similarly, other states have filed similar emergency petitions to protect incarcerated people. however, will this intervention be the answer to prevent the pandemic from spreading? a competing position is that the release of the incarcerated may further propagate the spread of covid- . a majority of the individuals in jail are pretrial detainees and are often placed in jail because they were unable to afford bail or were not granted bail. since these individuals are in a preadjudication status, they are innocent as defined by the constitution. however, they often lack an effective re-entry plan in place if they are to be released. in addition, there is a greater burden of mental health and homelessness among the incarcerated, as well as higher rates of unemployment before and after incarceration. [ ] [ ] [ ] according to a report released by the u.s. department of justice bureau of justice statistics released in , indicators of mental health problems reported by prisoners and jail inmates, - , % of jail inmates and % of prisoners self-reported that they were told by a medical professional that they had a mental health disorder. other estimates of mental health disorders are much greater. formerly incarcerated people are also times more likely to be homeless in comparison with the general public according to a report by the prison policy initiative. if these individuals are to be released, they would likely find themselves in shelters that are also overcrowded facilities with individuals living in close proximity to other individuals and further the spread of this pandemic. in addition, there is limited capacity of other nonprofit organizations for the homeless, such as soup kitchens, to meet the needs of this population. jail deincarceration is necessary but it must be balanced for the safety of the incarcerated and the public. it may be negligent to release thousands of people who will face hiring discrimination at the beginning of an economic downturn and in the middle of a pandemic. state and federal correctional facilities are reviewing records of incarcerated people to see whether they can be reclassified and possibly released or relocated to a less crowded unit or facility. a solution to this nuanced problem would be the voluntary release of incarcerated individuals from jails given the majority of individuals in jails are pretrial, with the exception that they are not deemed a threat to the public. in addition, ensuring that re-entering people have stable housing upon release is vital and some states are actually turning to hotels to meet this need. advocating for voluntary jail release reflects the burden of homelessness, employment barriers and discrimination, and mental health in this population. furthermore, it demonstrates understanding that placing re-entering people on the streets without employment opportunities or housing security will further worsen the current situation. nearly all in-person educational and personal development programming in jails and prisons are canceled. this not only removes healthy outlets for people on the inside but also removes opportunities to earn money working in nonessential parts of a prison, such as library facilities or participate in programs that can reduce a person's sentence. to mitigate the stress of increased isolation during social distancing, advocating for free texting, calling, and video chat services from prison telecommunications companies is essential. given the mental health burden in prisons, it is necessary to take steps toward eliminating the charge associated with communication services. currently, edovo, a telecommunication and technology education company, has taken initiative by providing connection in the midst otugo and wages; health equity , . http://online.liebertpub.com/doi/ . /heq. . of social distancing by supplying free access to messaging and calling to the incarcerated. to do no harm to this disenfranchised population, the first step is recognizing that there is a problem with health care in correctional facilities. it begins with accountability and continues with addressing the needs of this vulnerable population. voluntary jail release offers a solution to supporting those who are incarcerated during this time. the solution also includes ensuring access to adequate health care, removing copays for medical care that often act as barriers to care, reducing overcrowding in facilities, as well as improving access to hygienic products. furthermore, it is essential to address the mental health needs of this population which begins by understanding that social distancing does not equate to emotional distancing during this pandemic. no competing financial interests exist. no funding was received for this article. mass incarceration: the whole pie correctional control : incarceration and supervision by state prevalence and predictors of chronic health conditions of inmates newly admitted to maximum security prisons linkages between incarceration and health understanding and addressing health disparities and health needs of justice-involved populations prisoner serving time for drug charge is first u.s. inmate to die from covid- . the new york times something is going to explode'': when coronavirus strikes a prison. the new york times the gap between the number of blacks and whites in prison is shrinking. pew research center committee on causes and consequences of high rates of incarceration committee on law and justice; division of behavioral and social sciences and education; national research council; board on the health of select populations; institute of medicine. impact of incarceration on health inmates are manufacturing hand sanitizer to help fight coronavirus how coronavirus could affect u.s. jails and prisons even in prison, health care often comes with a copay. npr.org momentum is building to end medical co-pays in prisons and jails high court considers releasing some prisoners to prevent covid- outbreak the challenges of reentry. vera homelessness and housing insecurity among former prisoners the impact of limited housing opportunities on formerly incarcerated people in the context of addiction recovery mass incarceration and subsequent preventive health care: mechanisms and racial/ethnic disparities indicators of mental health problems reported by prisoners and jail inmates nowhere to go: homelessness among formerly incarcerated people could coronavirus cause a national prison lockdown? us news and world report inmates to receive free phone calls during decreased visit abbreviation used covid- ¼ coronavirus disease publish in health equity -immediate, unrestricted online access -rigorous peer review -compliance with open access mandates -authors retain copyright -highly indexed key: cord- -b w z authors: von tigerstrom, barbara j; halabi, sam f; wilson, kumanan r title: the international health regulations ( ) and the re-establishment of international travel amidst the covid- pandemic date: - - journal: j travel med doi: . /jtm/taaa sha: doc_id: cord_uid: b w z as countries modify or lift travel restrictions implemented in response to the covid- pandemic, some variation in approaches is to be expected, but harmonization is important to re-establishing international travel. despite challenges, the international health regulations ( ) and who recommendations can provide a balance of consistency and flexibility. pandemic, some variation in approaches is to be expected, but harmonization is important to reestablishing international travel. despite challenges, the international health regulations ( ) and who recommendations can provide a balance of consistency and flexibility. the the first half of the year has seen all countries in the world close their borders or strictly limit international travel as a way to reduce the spread of sars-cov- . after initial reactions that these restrictions were unnecessary and unlawful, the reality now appears more complex. some early analyses suggest that travel restrictionsif implemented in an evidence-based and timely waycould be justifiable public health measures. when the sars-cov- outbreak was declared to be a public health emergency of international concern (pheic) on january , , the who did not recommend any restrictions on travel or trade. only two months later, however, border closures and significant restrictions on international travel had become the norm, as a range of influences, including domestic political pressures, led states to implement restrictions contrary to who recommendations. these restrictions have had a dramatic effect: for example, a reduction in global air passenger traffic of up to seventy per cent is predicted for , causing billions of dollars in estimated losses. despite the pandemic continuing and worsening in many parts of the world, some countries have begun to lift or modify restrictions. there is increasing pressure to allow cross-border traffic due to the impact of restrictions on supply chains and national economies. in order to accomplish this while mitigating the public health risks of increased travel, countries are exploring a range of different approaches, including one or more of:  selective removal of restrictions for neighbouring countries or countries with similar epidemiological profiles (sometimes referred to as a "travel bubble" or "air bridge");  broader removal of restrictions, with exceptions for countries assessed to be higher risk;  replacing restrictions on entry with testing, quarantine, and/or mandatory contact tracing requirements;  requiring quarantine for returning residents or travellers, as international arrivals increase; and  adding or broadening exemptions for specific categories of travellers. as countries move forward with these changes, a harmonized and coordinated approach is critically important. a patchwork of different approaches could impede efforts to safely restart tourism, and variations in requirements can present practical difficulties. for example, there are different types of testing available, appropriate in different circumstances, and testing may be required at different time points before departure or on arrival, depending on the destination. consistent and appropriate testing requirements could prevent unnecessary burdens for travellers and service providers, and a harmonized system to share test results can facilitate travel. as another example, the utility of digital contact tracing apps would be enhanced if they were internationally interoperable. a range of different organizations have introduced guidelines that aim to provide some consistency. as might be expected, much of this activity has occurred in europe, aiming to restore the open borders and free movement that are the norm within the region. industry associations have also proposed harmonized measures. the ihr ( ) provide for several mechanisms that could be used during and after a pheic to establish common approaches to public health and international travel. although their role in an emergency receives the most attention, many provisions on public health measures also apply outside of the emergency context. together, these provisions and who recommendations provide a framework for international travel during the pandemic and beyond. once a pheic is declared, the who director-general must issue temporary recommendations, which can include measures to be applied to persons or cargo to "reduce the international spread of disease and avoid unnecessary interference with international traffic." temporary recommendations automatically expire after three months, unless they are modified or extended (again for three months). in the covid- pandemic, temporary recommendations were issued on january and again on april . neither recommended limiting international traffic, but in april, states were advised to implement "appropriate travel given the expectation that the covid- pandemic will continue in various forms for some time, one question is when the current pheic will end, and how this would affect who's role. once issued, however, temporary recommendations can be modified or extended, even after a pheic has ended, although not indefinitely. in addition, new temporary recommendations can be issued "as necessary for the purpose of preventing or promptly detecting its recurrence." these provisions allow the who director-general to provide guidance on re-establishing travel while addressing the continued risks of transmission and resurgence. in addition, standing recommendations can be issued at any time on the advice of a review committee, for "appropriate health measures" for "routine or periodic application," to address a specific health risk. this process could be one way of making recommendations on an ongoing basis, although formal standing recommendations do not appear to have been issued previously. the ihr ( ) also contain a number of provisions regarding public health measures that member states can use at any time. for example, specific articles deal with points of entry, public health measures applied to travellers, treatment of travellers, and health documents. these could provide a framework to promote consistency in standards for testing or vaccination requirements or medical certificates. challenges for the who's role include a loss of credibility given the lack of guidance on travel restrictions in earlier stages of the pandemic, as well as widespread disregard for recommendations that were given. in the absence of a multi-lateral agreement, bilateral or regional arrangements may proliferate, further undermining global governance initiatives. although some variation between regions is to be expectedparticularly where, as in europe, regional arrangements on free movement pre-existed the pandemicthe ihr ( ) interim guidance. may . https://www.who.int/publications/i/item/controlling-the-spreadof-covid- -at-ground-crossings (last accessed july ). do not violate the international health regulations during the covid- outbreak covid- travel restrictions and the international health regulations the effectiveness of full and partial travel bans against covid- spread in australia for travellers from china during and after the epidemic peak in china nd ed. geneva: world health organization second-meeting-of-the-international-health-regulations-( )-emergency-committee-regardingthe-outbreak global coordination on cross-border travel and trade measures cruicial to covid- response international civil aviation organization. council aviation recovery task force (cart) europe's patchwork reopening international air transport association. criteria for covid- testing in the air travel process cross-border travel is confusing after covid -this framework can help borders reopen safely world tourism organization. global guidelines to restart tourism covid- : toward a phased and coordinated approach for restoring freedom of movement and lifting internal border controls international air transport association and airports council international world health organization. considerations in adjusting public health and social measures in the context of covid- : interim guidance solidarity in the wake of covid- : reimagining the international health regulations emergency committee regarding the outbreak of coronavirus disease (covid- ) countries' response to who's travel recommendations during the - ebola outbreak world health organization. management of ill travellers at points of entry (international airports, seaports, and ground crossings) in the context of covid- : interim guidance key: cord- -lwbddab authors: antiporta, d. a.; bruni, a. title: emerging mental health challenges, strategies and opportunities in the context of the covid- pandemic: perspectives from south american decision-makers. date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: lwbddab background mental health awareness has increased during the covid- pandemic. although international guidelines address the mental health and psychosocial support (mhpss) response to emergencies, regional recommendations on covid- are still insufficient. we identified emerging mental health problems, strategies to address them, and opportunities to reform mental health systems during the covid- pandemic in south america. methods an anonymous online questionnaire was sent to mental health decision-makers of ministries of health in south american countries in mid-april . the semi-structured questionnaire had questions clustered into main sections: emerging challenges in mental health, current and potential strategies to face the pandemic, and, key elements for mental health reform. we identified keywords and themes for each section through summative content analysis. findings an increasing mental health burden and emerging needs are arising as direct and indirect consequences of the pandemic among health care providers and the general population. national lockdowns challenge the delivery and access to mental health treatment and care. strategies to meet these health needs rely heavily on timely and adequate responses by strengthened mental health governance and systems, availability of services, virtual platforms, and appropriate capacity building for service providers. short- and medium-term strategies focused on bolstering community-based mental health networks and telemedicine for high-risk populations. opportunities for long-term mental health reform entail strengthening legal frameworks, redistribution of financial resources and collaboration with local and international partners. interpretation mental health and psychosocial support have been identified as a priority area by south american countries in the covid- response. the pandemic has generated specific needs that require appropriate actions including: implementing virtual based interventions, orienting capacity building towards protection of users and health providers, strengthening evidence-driven decision making and integrating mhpss in high-level mechanisms guiding the response to covid- . funding none. the covid- pandemic has affected mental health and wellbeing as well as its determinants. general population have reported anxiety and stress while health professionals fear, and bereavement. mental health services have also been overburdened as the health needs increase as consequence of the pandemic and the isolation measures in place. the who general director has recognized mental health and psychological support (mhpps) as a major pillar in the overall health response to the covid- pandemic. likewise, the inter agency standing committee (iasc) published a global briefing recommending eight mhpps interventions to be implement during the crisis. nonetheless, evidence to guide action at regional and sub-regional levels is still insufficient. this study provides expert perspectives of decision-makers about mental health burden and actions during the covid- in south america, currently the most serious hub of infection worldwide. health services have reported an increase of anxiety, stress and fear among the general population emerging during the pandemic. the pandemic has generated specific needs that require appropriate actions including implementing virtual based interventions, bolstering community-based mental health networks, and integrating mhpss in high-level mechanisms guiding the response to covid- . decision-makers identified opportunities to seize for long-term mental health reform such as strengthening legal frameworks, redistribution of financial resources and collaboration with local and international partners. the importance of this research goes beyond documenting the status quo of mental health at country level, but implies fostering, enhancing and expanding collaborations in the sub-region to strengthen the mental health response to the covid- pandemic. country-cooperation initiatives in mental health have been an important strategy to improve local mental health systems and services. our findings are expected to better orient next steps in making decisions on mental health policies and services in south america, but also to inform public health key leaders and mental health experts within and beyond the region of the americas. mental health and psychosocial problems are expected to rise during adversity and crisis ( ) , such as the covid- pandemic ( ) , but awareness of mental health has already increased in media and academic platforms ( ) . general population have reported anxiety and stress ( , ) while health professionals and frontline aid workers reported fear and bereavement ( ) . isolation measures, discontinuity in health services, and scarce availability of medications represent additional barriers to preserving a good mental health. mental health and psychosocial support (mhpss) have been recognized as major components within the overall health response to the covid- pandemic ( ). mhpss include strategies to protect or promote psychological well-being and prevent mental conditions. the inter agency standing committee (iasc) has provided guidelines to address mental health and psychosocial aspects during the epidemic ( ) . while the iasc provides guidance on a global level, evidence to guide action at regional and sub-regional levels is still insufficient. region and country-based research can help reduce the evidence-gap on local mental health action and strategies. historically mental health care has been severely under-resourced; however, some regions like south america have made substantial progress regarding national policies and legal frameworks. for instance, peru initiated a radical mental health reform in that produced a shift from a hospital-centered mental health towards a community-based model ( ) . in paraguay was identified as the only country in the region of the americas to participate in the who mental health special initiative, which aims to ensure universal health coverage for mental health ( ) . the sars-cov- virus has spread widely in south america with , , confirmed cases and , deaths as of june th , ( ). recent forecasting models suggest a dramatic scenario for the coming . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted july , . . https://doi.org/ . / . . . doi: medrxiv preprint months projecting substantial increase in cases and deaths by august( ), despite wide lockdowns and curfews implemented in several countries. while many south american countries are fiercely fighting against the spread of the virus, additional challenges, for example increased mental health needs, have arisen amidst this pandemic. key responses in mental health entail a deeper understanding of local needs and interventions as well as identification of opportunities to strengthen mental health care. the relevance of this study lies in the need to generate evidence on the radical changes and emerging challenges created by the covid- pandemic. we gathered information from decision makers on the main needs in terms of mental health and wellbeing in south america. we identified emerging mental health challenges and strategies to reduce the negative impact of the epidemics, and, key opportunities to reform mental health systems and services by seizing opportunities during the crisis. we identified mental health focal points in ministries of health in all countries that belong to the pan american health organization (paho) south american subregion: argentina, bolivia, brazil, chile, colombia, chile, paraguay, peru, uruguay, and venezuela. electronic invitations were sent by email to at least one focal point per country between the april - , . eligible participants were ) at least years old, and, ) holding a high-level managerial position within their mental health directions or units. an anonymous online questionnaire was designed in qualtrics (provo, ut) about mental health in the context of the covid- pandemic. the questionnaire (see table ) had country-specific questions, divided in three sections: ) emerging challenges in mental health, ) current and potential strategies . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted july , . . https://doi.org/ . / . . . doi: medrxiv preprint (short-term, next two months, and medium-term, next six months, to face the pandemic, and, ) strategies and opportunities for mental health reform. the questionnaire had a semi-structured format and was designed to last around minutes to complete. following ethical principles, all participants voluntarily consented to participate in this questionnaire. the protocol and questionnaire were submitted to the johns hopkins bloomberg school of public health and the paho ethics review committee and all procedures were exempted for review. a qualitative approach was used performing summative content and thematic analysis. the research team first read the raw data of questionnaires and generated an initial codebook. the codebook and themes were revised and updated based on gaps shown by the initial list. early versions of findings were jointly reviewed by the team to agree on interpretability of results. analytical products are themes and keywords by each section. we used the software atlas.ti for windows to facilitate the data management and organization. for this study, we have used the following terms considering the local context and the purposes of the study. we have used the terms lockdown, quarantine, and home-stay policies interchangeably. while most participants referred to home-stay policies or lockdowns, they used the term "quarantine" in all cases to describe these policies. by stress reactions, we intended to capture all mental and psychosocial conditions and reactions that require 'any type of support that aims to protect or promote psychosocial wellbeing and/or prevent or treat mental disorder( ). this included keywords such as stress, post-traumatic stress, acute stress, and severe stress. lastly, we used anxiety to describe terms such as anxiety disorders and anguish. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . . there was no funding source for this study. the corresponding author and first author had full access to all the data and had final responsibility for the decision to submit for publication. we received back out of complete questionnaires representing countries, and % of respondents were female. the median time for completion was minutes (iqr= min). all respondents worked in high ranked decision-making positions in mental health units, programs, or departments in their ministry of health of their respective countries. informants reported up to different emerging problems across countries. the most frequent mental health and psychosocial reactions reported were anxiety ( mentions), stress ( mentions), and fear ( mentions). reactions were attributed not only to the pandemic itself but also to public health measures that countries implemented to control the disease, such as total lockdowns and home-stay policies. another common topic was domestic violence affecting children and women. less frequent problems included insomnia, irritability, solitude, and sadness, especially among those who are living alone. informants were asked to rank the top different emerging problems based on the urgency to intervene. anxiety or anxiety disorders were ranked top across informants, although few also indicated stress reactions and fear. the second highest problem was not equally homogenous across informants, and answers ranged from an increase in consumption of substances, to stress reactions and depression. the third top priority was heterogenous and included domestic violence, substance use and impulsive reactions. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . . https://doi.org/ . / . . . doi: medrxiv preprint participants indicated several challenges for mental health care delivery arising during the covid- pandemic, for which the identification of high-risk populations is necessary to plan appropriate responses. prioritized target populations include service providers, patients who were already in contact with the mental health services and potential new users that might need mental health support as a result of the pandemic, including those people that lost a relative or a loved one. the focus on health providers should not be limited to emergency room (er) and intensive care unit (icu) health professionals but should include mental health professionals as well. challenges that referred to the services offered were grouped into outpatient services, inpatient care, and availability of medications. outpatient services challenges included the limited capacity of health services to use virtual/telemedicine platforms to provide care to specific populations, i.e., elderly people, and indigenous communities, or to disseminate key messages and relevant information through mass media. challenges for inpatient care concerned adequate time for admissions and care provided during the lockdown. disruption in availability of psychotropic medications was described in terms of reduced access and distribution to inpatient and outpatient care facilities. other challenges related to organizational interventions and training for health providers. participants referred to the need for an action plan to strengthen community based mental health services and bridge the mental health treatment gap. they also referred to the need for synergies with public institutions and civil society to strengthen public mental health surveillance, interventions, and communication. additional challenges were the limited availability of virtual platforms and limited time for training service providers on adequate responses of mental health care, such as psychological first aid. the challenge that ranked highest was to maintain or reopen primary mental health care services to adequately respond to the needs of affected people and overcome the limitations of providing mhpss . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . . https://doi.org/ . / . . . doi: medrxiv preprint interventions during the lockdown. other topics included the training of mental health providers, distribution of medications and caring for mental health providers. the second highest challenge was heterogeneous across participants: some referred to caring for the mental health and wellbeing of frontline workers, and adequate functioning of inpatient care. challenges ranked as the highest third referred to establishing or strengthening intersectoral work and providing psychosocial support to people and families affected by covid- . the main reported barriers for accessing mental health services, including therapies and other types of care, are the national lockdown measures, which have shut down most primary health centers to stop spreading the disease. scarce resources to reorganize mental health services to virtual forms and systems for appointments were also described as challenges that jeopardize access to services. the delivery of virtual-based treatments and interventions relies on the availability of services as well as patient's expertise to use technological tools, which are not optimal during the current scenario. access to care is also reduced due to the limited number of professional and functioning community centers with mental health care available during the pandemic. access to medications was also reported as a potential challenge given the lower availability of psychotropic medications as compared to those used in general health and for conditions related to the covid- . the highest ranked challenge was the continuity of care using strategies that respect the lockdown measures and providing appropriate care for patients. another topic that ranked highly was the limited availability of trained mental health providers in the primary care level. as second top challenges, participants described limited access to psychotropic medications during the pandemic as well as the lack of training and resources to implement telemedicine sessions. the third top challenge mentioned by participants was reaching out to vulnerable populations, such as those with low income. another topic . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . . https://doi.org/ . / . . . doi: medrxiv preprint was the activation of emergency services for mental health to respond to increased demand during this crisis. strategies that have been implemented frequently during this time included the use of mass communication media, at national and local levels by ministries of health and community health centers. communications were tailored by life course stage or ethnicity in some countries. ongoing efforts aim to promote self-help mechanisms through social networks, at the national, regional, and municipal level. other strategies included establishing or strengthening mental health services through telemedicine and national or local hotlines for mental health care and psychosocial support. some countries reported hotlines for specific populations such as the elderly or people with disabilities. additional use of virtual platforms was referred by some respondents to implement mental health training, the exchange of experiences between territories and reporting to stakeholders from the national and local levels. a common short-term strategy was to ensure the adequate mental care of admitted persons, their families, and health providers at psychiatric hospitals as well of those in the highest risk units (i.e. er and icu). special attention was given to those patients who might need to be admitted in a context of limited availability of beds. psychosocial support was considered a crucial strategy to prevent stress reactions due to burnout and other consequences of the pandemic among health providers. access to pharmacological treatment was also a concern during the early stages. some strategies proposed to bridge the gap included the establishment of a virtual delivery system and partnerships with existing pharmaceutical networks to facilitate the access to these treatments. communication strategies for psychosocial education and support considering cultural and gender perspectives were also suggested. examples of the latter is the digital system of mental health care for health providers in chile. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . . https://doi.org/ . / . . . doi: medrxiv preprint for the medium-term, strong relevance was given to the creation and use of virtual platforms and applications for delivery of mental health services, strengthening of social networks and offering psychosocial support. a mobile application in colombia that aims to screen for covid- symptoms, was cited as an example of an app that can provide mental health care information to a wider population. the need for a community-based mental health system, which strengthens the capacities of non-specialized primary health providers, was a recurrent topic among respondents. participants also mentioned the elaboration or strengthening of protocols and programs to provide care to people positive for covid- , specific populations, through the adequate implementation of the mental health gap action programme (mhgap) in the areas most affected by the crisis. participants also referred to the need for mental health professionals to be included in the multidisciplinary team that provides care to people affected by covid- . the increased awareness of mental health by stakeholders, media, and the general population, during the pandemic and the lockdowns, represents an opportunity to increase visibility of mental health, to mobilize resources and to prioritize mental health policies and interventions. communication strategies through social media and official channels can highlight the importance of mental health by offering self-help messages to manage stress and other reactions during the lockdown period. training health care providers in mental health strategies can increase awareness among these professionals. effective advocacy and leadership need to focus on strengthening mental health planning and legislation to adequately respond to the pandemic. the creation and inclusion of commissions for mental health within technical working groups will allow mental health services to be prioritized not only in the current response but also in the post-pandemic scenario. partnerships with local organizations and civil society are key to enhance the role of mental health response during the crisis. . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . . https://doi.org/ . / . . . doi: medrxiv preprint reorienting mental health services towards a community-based system will provide appropriate care tailored to the needs of the population. moreover, building information systems using timely and robust data will allow the monitoring of mental health burden and associated factors, to better inform stakeholders. when asked about opportunities to mobilize additional financial resources for mental health, respondents had few suggestions based on their country experience. some suggested redirecting resources from more specialized facilities towards the primary health networks or community-based centers. effective collaborations with local and regional authorities might facilitate the implementation of current mental health policies and lead to allocation of additional funds. international partners, such as cooperation bodies, were considered as potential sources of financial support and collaboration for articulated efforts in mental health care during the pandemic. the most cited institutions were paho/who ( / respondents) and unicef ( / respondents). on average, each participant reported at least institutions. an emerging burden of mental health needs is arising as direct and indirect consequences of the pandemic among the general population as well as health care providers in south america. national lockdowns and social distancing measures challenge the delivery and access of mental health care and treatment. strategies to meet these health needs heavily rely on timely and adequate responses by strengthened mental health governance and systems, availability of services and virtual platforms and appropriate capacity building for service providers. short-and medium-term strategies focus on the implementation of community-based mental health systems, virtual support, communications, and appropriate care for populations in vulnerable or high-risk settings. opportunities for long-term mental . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . . health reform entail strengthening legal frameworks, redistribution of financial resources and collaboration with local and international partners. situations of emergencies normally translates into higher prevalence of mental conditions, including stress reactions, common and severe mental disorders ( , ) . participants reported a higher burden of anxiety and stress in their respective countries. other reactions can be also expected in severe covid- infections such as fatigue, delirium, and neuropsychiatric syndromes ( ) . detrimental effects in mental health have been reported in the general population ( , ) , health providers ( ) ( ) ( ) as well as overburdening health services ( ) . the novel cohabitation circumstance, consequence of lockdowns and home-stay policies, may represent an opportunity for exchange among family members and loved ones, but at the same time may result in increased tensions ( , ) and violence( ), including violence against women and children. home confinement has increased the prevalence of depressive symptoms among children ( ) . people with mental health disorders and disabilities may suffer further disruption in services and accommodation prior to covid- ( ) . increased consumption of alcohol and psychotropic substances will turn a difficult situation into a more challenging scenario. mental health plays a pivotal role in this context since it has plenty to contribute to improving positive coping mechanisms to face new challenges and hardships participants emphasized the relevance of ensuring the continuity of services. the capacity to adjust to the increased volume of people in need largely depends on the previous mental health infrastructure. importantly, health systems with well-developed community-based mental health networks are more likely to adjust to the novel scenario. conversely, health systems that are centered in acute care hospitals and psychiatric hospitals will struggle to respond to the increasing needs of the population and the preexisting mental health treatment gap may become more dramatic. the ministry of health of peru, for instance, is taking measures to ensure the community-based mental health centers keep functioning in a . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted july , . where they implemented surveys, mental health education and psychological counselling services though online services ( ) . in colombia, a smartphone application was launched to provide support to covid- affected populations; this application includes a component entirely dedicated to mental health that orient users and provides them with appropriate information( ). maintaining a limited proportion of face-to-face interventions seems to be crucial, provided that sufficient protective measures are always taken to protect service users and health professionals. those settings where community-based services are more developed will be better positioned also to reorient the methods of delivering services and 'go virtual'. situations of crisis, such as the covid- pandemic, despite its inherent disruptive dramatic consequences, may generate important opportunities for improving mental health services( ). all respondents in our study presented their insights in seizing potential opportunities to reform mental health services in a long-term perspective. given the special nature of covid- and its profound impact on mental health and wellbeing of populations, this long-term approach seems fundamental in providing insights to decision makers beyond the most immediate response to the critical event. this study identified decision makers in high rank positions of mental health units at ministries of health as key informants during the early stage of the pandemic in south america. besides sharing their expert . cc-by-nc-nd . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted july , . . opinion, this group was instrumental in identifying specific strategies to operationalize recommendations. despite participants being high-ranking officials, the survey was directed to a limited number of individuals. thus, the authors acknowledge the need for generating additional evidence and further investigate the perspectives of relevant key actors, including: senior mental health professionals, such as psychiatrists and psychiatric nurses, but also representatives from civil society such as service users and their family members or caregivers. we gathered information from all countries except for brazil, the biggest and most affected country by covid- pandemic in the subregion( ), due to administration changes during the time of data collection. nevertheless, our aim was to portray a sub-regional situation in mental health challenges and not country-specific profiles, for which collecting information from decision-makers of out of countries allowed us to fulfill the objective. mental health and psychosocial support have been identified as a priority area by south american countries in the covid- response. the pandemic has generated specific needs that require appropriate actions including: implementing virtual based interventions, orienting capacity building towards protection of users and health providers, strengthening evidence-driven decision making and integrating mhpss in high-level mechanisms guiding the response to covid- . the results of this study are expected to better orient next steps in making decisions on mental health policies and services in south america, but also to inform public health key leaders and mental health experts within and beyond the region of the americas. world health organization & united nations high commissioner for refugees. assessing mental health and psychosocial needs and resources: toolkit for humanitarian settings the mental health consequences of covid- and physical distancing: the need for prevention and early intervention the lancet p. mental health and covid- : change the conversation stress, anxiety, and depression levels in the initial stage of the covid- outbreak in a population sample in the northern spain covid- and mental health: a review of the existing literature -ncov epidemic: address mental health care to empower society addressing mental health needs: an integral part of covid- response interim briefing note addressing mental health and psychosocial aspects of covid- outbreak peruvian mental health reform: a framework for scaling-up mental health services world health organization. the who special initiative for mental health ( - ): universal health coverage for mental health. geneva: world health organization, . . pan american health organization (paho). cumulative covid- cases boadle a. who says the americas are new covid- epicenter as deaths surge in latin america. reuters improving mental health care in humanitarian emergencies psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the covid- pandemic mental health outcomes among frontline and second-line health care workers during the coronavirus disease (covid- ) pandemic in italy prioritizing physician mental health as covid- marches on mental health care for medical staff in china during the covid- outbreak mental health in the coronavirus disease emergency-the italian response mental health at the age of coronavirus: time for change. soc psychiatry psychiatr epidemiol mental health status among children in home confinement during the coronavirus disease patients with mental health disorders in the covid- epidemic online mental health services in china during the covid- outbreak. the lancet psychiatry the authors acknowledge the participants of this study, their disposition to contribute to our research and the mental health responses they are leading in their countries. potential and current strategies to reduce the negative impact of the epidemics on mental health and wellbeing . .what key strategies are being implemented to specifically address the mental health and wellbeing needs affected by the epidemic? what innovative actions and interventions would you consider for implementation in the short-term response? what innovative actions and interventions would you consider for implementation in the medium-term response? key elements to reform mental health systems and services seizing opportunities during the crisis. despite their tragic nature, and notwithstanding the human suffering they create, emergency situations are also opportunities to build better mental health care. what strategies should be adopted for prioritize mental health in the political agenda? what opportunities have you identify to mobilize additional financial resources? who are the international partners that you identify to support and strength mental health services? key: cord- - bmonj authors: liem, andrian; sit, hao fong; arjadi, retha; patel, anushka r.; elhai, jon d.; hall, brian j. title: ethical standards for telemental health must be maintained during the covid- pandemic date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: bmonj nan public health measures, including physical distancing during the covid- pandemic, necessitate telemental health, such as videoconferencing, to maintain continuity in clinical care for psychiatric outpatients. the use of technology in telemental health services is not only for curative purposes but also for assessment and monitoring as part of psychological first aid for the covid- pandemic. , telemental health is also a strategy to close the global mental health treatment gap, especially within low-and middle-income countries. , , despite increased interest in telemental health, the pandemic created a sudden switch from offline to online modalities challenging clinicians to rapidly adapt to meet patients' needs. for example, more than two-thirds of psychologists in a highincome country like the us have never conducted videoconferencing to deliver their therapeutic services. this number is higher in low and middle-income countries in asia, for example, about % of clinicians in bangladesh have never provided telemental health services to their patients. early career clinicians in iran provided digital support groups through chatting apps (e.g., whatsapp and telegram) and social media (i.e., facebook), and some of them did not use this digital remote support previously. neophyte online clinicians might not be aware of possible ethical and privacy concerns related to technology use in their practice. , , additionally, telemental health services may not be regulated yet in health law, particularly in asian countries. there are five key ethical concerns clinicians need to be aware of before engaging in telemental health. first is to ensure confidentiality due to the complexities inherent in online treatment. for example, clinicians must ensure that their online communication has end-to-end encryption, to prevent access by a third party. one of the most widely used video conference providers was recently j o u r n a l p r e -p r o o f challenged on its stated privacy policy. second, clinicians must have practical competence to deliver online interventions, including assisting patients when they face logistical issues. third, clinicians need to update their knowledge and comply with the newest regulations related to online interventions. for instance, clinicians in the us may use smartphones (in addition to desktop computers) in delivering their telehealth services during the covid- public health emergency. also, the benefits for treatment should be weighed against the possibility that either clinicians or patients may not have adequate resources for conducting online interventions (i.e., a stable and secure internet connection). fourth, similar with in-person interventions, clinicians are obligated to seek informed consent prior to intervention, and review risks and benefits of treatment. this is even more critical for telemental health, given the privacy concerns already mentioned. fifth, clinicians must engage in contingency planning for emergency services (i.e., suicidal intent), first determining the patient's physical location pre-emptively beforehand, in case the application used in delivering the intervention malfunctions. a brief checklist covers these five ethical standards for telemental health is provided in table and can complement the available mental health interventions during the covid- pandemic. , , telemental health is promising for use during the covid- pandemic, including in asian countries. therefore, clinicians must maintain the highest ethical standards in order to deliver quality treatment that safeguards the welfare and best interests of their patients. professional organisations and educational institutions should also include training in telemental health in the future. we declare no competing interests. this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. we declare no competing interests.  assure that any software / program that used in the session is end-to-end encrypted to protect the data. if end-to-end encrypted software / program is not available, clinicians must explain the risks of being hacked or privacy violation to patients.  assure no one else could listen the session (unless it is a part of the intervention and being agreed prior to the session, for instance, parent or legal guardian for the minors).*  parents or legal guardians of minors should grant privacy during online sessions.  adequate knowledge and competency in using the software, hardware, and network for providing online interventions, including problem solving skills on related-logistic issues that patients may experience.  consider patient's cognitive and clinical status as well as their comfort in using technology effectively and safely.  clinicians should be culturally sensitive, approaching patients with cultural humility, regardless the modality of intervention.  check and comply with regulations and policies related to reimbursement eligibility / procedure from insurance company / health care system for online interventions.*  check and comply with regulations and policies from the government (local and national level) and professional organisations related to online interventions.  inform and discuss the potential risks and benefits of online interventions and how it differs from in-person sessions with the patient.  if needed, discuss how the online session will be billed.  collect a signed consent from patient (or parent or legal guardian of minor). secure electronic signing platform (i.e., dochub) can be used if the patient cannot sign a hardcopy form.  obtain at least one emergency contact for the patient prior to the session in case the patient is in a crisis.  provide a phone number that can be reached by the patient in case any technical problems with the hardware, software, or internet connection arise.  prior to the session, find the closest health services with patient's location in case patient needs emergency response.  clinicians should discuss how the patient's physical environment, family composition, personal privacy, and living arrangements may impact their treatment engagement. clinicians should then collaboratively problem-solve for anticipated barriers (e.g., strategic use of the chat function on secure videoconferencing apps when family members may be in rooms). note. * = may also applied for patients. clinician should not rely on this table only and should seek more detail ethical standards from their government and professional organisation before providing telemental health services. mental health interventions during the covid- pandemic: a conceptual framework by early career psychiatrists remote consultations in the era of covid- pandemic: preliminary experience in a regional australian public acute mental health care setting internet-based behavioural activation with lay counsellor support versus online minimal psychoeducation without support for treatment of depression: a randomised controlled trial in indonesia psychiatrist in post-covid- era -are we prepared? survey of psychologists' telebehavioral health practices: technology use, ethical issues, and training needs a survey on the assessment of the present states and opportunities of telemedicine in bangladesh what the covid- telehealth waiver means for psychology practitioners how secure is mental health providers' electronic patient communication? an empirical investigation technology use in mental health practice and research: legal and ethical risks telemedicine practice guidelines: enabling registered medical practitioners to provide healthcare using telemedicine digital health applications in mental health care for immigrants and refugees: a rapid review zoom, the video conferencing app everyone is using, faces questions over privacy the covid- pandemic personal reflections on editorial responsibility. asian journal of psychiatry references: key: cord- -it ygo authors: lotzin, annett; acquarini, elena; ajdukovic, dean; ardino, vittoria; böttche, maria; bondjers, kristina; bragesjö, maria; dragan, małgorzata; grajewski, piotr; figueiredo-braga, margarida; gelezelyte, odeta; javakhishvili, jana darejan; kazlauskas, evaldas; knefel, matthias; lueger-schuster, brigitte; makhashvili, nino; mooren, trudy; sales, luisa; stevanovic, aleksandra; schäfer, ingo title: stressors, coping and symptoms of adjustment disorder in the course of the covid- pandemic – study protocol of the european society for traumatic stress studies (estss) pan-european study date: - - journal: european journal of psychotraumatology doi: . / . . sha: doc_id: cord_uid: it ygo background: during the current covid- pandemic, the people in europe are exposed to self-isolation, quarantine, job loss, risk of contracting covid- , or grief of loved ones. such a complex array of stressors may lead to symptoms of adjustment disorder or posttraumatic stress disorder. this research protocol describes a study launched by the european society of traumatic stress studies (estss) to investigate the impact of the covid- pandemic on symptoms of adjustment disorder across european countries. objective: the longitudinal online cohort study aims ( ) to explore psychosocial reactions to the covid- pandemic across ten european countries; ( ) to examine the relationships between risk and resilience factors, stressors and symptoms of adjustment disorder during the pandemic; and ( ) to investigate whether these relationships are moderated by coping behaviours. method: in ten countries (austria, croatia, georgia, germany, italy, lithuania, netherlands, poland, portugal, and sweden), between , and , participants will be recruited, depending on the size of the country. participants will be assessed at two timepoints with a six-month interval. following a conceptual framework based on the who’s social framework of health, an assessment of risk and resilience factors, covid- related stressors and pandemic-specific coping behaviours will be measured to estimate their contribution to symptoms of adjustment disorder. the adjustment disorder new module (adnm- ) will be used to assess symptoms of adjustment disorder. as a secondary measure, symptoms of posttraumatic stress disorder will be measure using the primary care ptsd screen for dsm- (pc-ptsd- ). data analysis: the relative contribution of risk factors, resilience factors, and stressors on symptoms of adjustment disorder or symptoms of posttraumatic stress disorder will be estimated using multilevel analysis. to determine the moderating effects of different types of coping behaviours on these relationships, a multilevel mediation analysis will be carried out. estresores, afrontamiento y síntomas de trastorno de adaptación en el curso de la pandemia de covid- -protocolo de estudio de la sociedad europea de estudios de estres traumático (estss) estudio pan-europeo antecedentes: durante la actual pandemia de covid- , las personas en europa están expuestas a autoaislamiento, cuarentena, pérdida de empleo, riesgo de contraer covid- o duelo de sus seres queridos. un conjunto tan complejo de factores estresantes puede provocar síntomas de trastorno de adaptación o trastorno de estrés postraumático. este protocolo de investigación describe un estudio lanzado por la sociedad europea de estudios de estrés traumático (estss) para investigar el impacto de la pandemia covid- en los síntomas del trastorno de adaptación en países europeos. objetivo: el estudio longitudinal de cohorte en línea tiene como objetivo ( ) explorar las reacciones psicosociales a la pandemia de covid- en diez países europeos; ( ) examinar las relaciones entre los factores de riesgo y resiliencia, estresores y síntomas de trastorno de adaptación durante la pandemia; e ( ) investigar si estas relaciones son moderadas por comportamientos de afrontamiento. método: en diez países (austria, croacia, georgia, alemania, italia, lituania, países bajos, polonia, portugal y suecia) serán reclutados entre , y , participantes, dependiendo del tamaño del país. los participantes serán evaluados en dos momentos con un intervalo de seis meses. siguiendo un marco conceptual basado en el marco social de salud de la oms, una evaluación de los factores de riesgo y resiliencia, factores estresantes relacionados con covid- y el comportamiento de afrontamiento específico de la pandemia serán medidos para estimar su contribución a los síntomas de trastorno de adaptación. el nuevo módulo de trastorno de adaptación (adnm- ) se utilizará para medir los síntomas del trastorno de adaptación. como medida secundaria, se evaluarán síntomas de trastorno de estrés postraumático usando el cribaje de tept en atención primaria para dsm- (pc-ptsd- ). análisis de datos: la contribución relativa de los factores de riesgo, factores de resiliencia y los estresores sobre los síntomas de trastorno de adaptación o síntomas de trastorno de estrés postraumático se estimará mediante análisis multinivel. para determinar los efectos moderadores de diferentes tipos de conductas de afrontamiento en estas relaciones, se llevará a cabo un análisis de mediación multinivel. with the global covid- pandemic, europe faces one of the most significant challenges in many years. population-wide public health measures to reduce the spread of covid- have disrupted social and economic systems. as in other regions of the world, the european populations are exposed to a variety of persistent stressors that can lead to mental health problems. these include social isolation, lack of childcare, loss of employment, having covid- , and loss of loved ones (brooks et al., ; fiorillo & gorwood, ; galea, merchant, & lurie, ) . given the psychological, social and economic burden placed on entire populations, the impact of the pandemic on mental health is a critical issue to be addressed (holmes et al., ) . subgroups of the general populations might be particularly vulnerable to develop mental health problems. people with a low socio-economic position may experience greater social and economic burden due to unemployment, low financial reserves and precarious working conditions (van dorn, cooney, & sabin, ). frequent consumption of news about covid- in social media seems to increase the perceived distress (gao et al., ) . elderly persons might be more distressed by measures of self-isolation than younger person due to fewer social contacts (armitage & nellums, ) . previous or current mental or physical health conditions (liu, chen, lin, & han, ) and previous trauma exposure (frewen, zhu, & lanius, ) may be additional factors that may place people at greater risk. people who have covid- , or who have personal contact with people who may have covid- , are prone to mental health problems. frontline health care workers may experience distress related to moral injury if they are unable to provide appropriate treatment due to a lack of needed resources (greenberg, docherty, gnanapragasam, & wessely, ; kang et al., ; lai et al., ) . when facing stressful situations, most individuals may cope in a resilient manner and react with strength to personal and social adversity (kitson, ) . however, during the current uncertain and acute crisis of the covid- pandemic, the accumulated stressors may disrupt mental health (rajkumar, ) . based on findings from earlier pandemics, one out of four individuals suffered from clinical symptoms (mihashi et al., ) . a study conducted in italy at the beginning of the current covid- pandemic showed that many individuals experienced psychological distress, particularly women (rossi et al., ) . symptoms of adjustment disorder or posttraumatic stress disorder (ptsd) were most often reported (rossi et al., ) . given the psychological burden during the covid- pandemic (lima et al., ) , the relationships between the cumulative risk and resilience factors, stressors, and stress-related symptoms should be investigated. the covid- pandemic characteristics and its development are not well understood. the course of the pandemic is unpredictable, although the most likely scenario is that covid- will continue to spread (cyranoski, ) . previous research has shed light on risks and mitigating factors of trauma and stress-related disorders; such knowledge could be helpful to design timely prevention strategies. at present, knowledge of the risk factors and stressors that contribute most to the psychological burden in the general population across different countries in europe is still sparse. according to the who's multilevel social framework of health (solar & irwin, ) , both social determinants of health inequalities and social determinants of health impact on mental health and disorders. such determinants include risk factors and stressors on the individual, community and country level nation. the covid- pandemic may have an impact on many, if not all, of these risk factors and stressors (see figure ). determinants of adverse mental health may include biological factors (e.g. having covid- or chronic illness), psychosocial factors (e.g. fear of contracting covid- , feeling isolated, perceived lack of social support, having intensive care unit treatment, death of loved ones, severe covid- infection of loved ones, working in health care), and material circumstances (e.g. financial and job loss, restricted housing conditions). behavioural factors, i.e. behaviours to cope with the stressors of the pandemic (e.g. physical exercise or substance use) may buffer or heighten the impact of pandemic-related stressors on mental health (allen, balfour, bell, & marmot, ) . determinants of mental health inequalities during the covid- pandemic comprise socioeconomic characteristics (e.g. loss of job, access to financial support), culture and societal values (e.g. stigmatization of vulnerable groups, limitation of individual rights), social and health policies (e.g. short-term work, access to health services), and public policies (e.g. physical distancing, restriction of free movement, quarantine, enforcing surveillance of individuals). tackling the covid- pandemic has placed immense pressure on healthcare systems around the world, health care workers are at increased risk of extreme stress and trauma exposure williamson, murphy, & greenberg, ) . different european countries enforce different public policies to respond to and manage the covid- crisis. some apply more restrictive and less participatory public policies (e.g. georgia, italy), while others decided upon less restrictive and more participatory approaches (e.g. sweden). european countries also differ in terms of socioeconomic factors, onset of the outbreak, social security, healthcare system, and in the extent to which supportive social policies are planned and implemented. moreover, european countries have different cultural values which not only shape the perception of the stressors, but have an impact on individual, family and collective coping strategies to deal with them. this study protocol describes a study launched by the european society for traumatic stress studies (estss). the study was planned with a specific focus on stress-and trauma-related disorders. an estss task force on psychosocial responses to covid- identified the need for such studies to fill the gap of knowledge about stress-and traumarelated mental health problems during the covid- pandemic (javakhishvili et al., ) . the study will examine the relationships between these complex risk and resilience factors, stressors, coping behaviour and stress-related symptoms during the covid- pandemic across ten european countries. the cohort study aims ( ) to explore psychosocial reactions to the covid- pandemic across ten european countries; ( ) to examine the relationships between risk and resilience factors, stressors and symptoms of adjustment disorder during the covid- pandemic; and ( ) to investigate whether the relationships between risk factors, resilience factors, stressors and symptoms of adjustment disorder are moderated by different types of coping behaviours. it is assumed that the selected risk factors, resilience factors and stressors are significantly associated with severity of adjustment disorder symptoms at t and t . the study was planned to be an online cohort survey involving the general population. the study will be conducted in ten european countries: austria, croatia, georgia, germany, italy, lithuania, netherlands, poland, portugal, and sweden. participants will be assessed at baseline (t ) and will be reassessed months later (t ) (figure ). the study will recruit participants from the general population who have access to internet. the inclusion criteria require all participants to be at least years old and to be willing to take part in the survey. in accordance to ethics standards, all participants are requested to provide an informed consent before taking part in the study. the countries involved in this study differ by population size. in light of this, the sample sizes will be n = , for countries with less than mio. inhabitants (austria, croatia, georgia, lithuania, portugal, sweden), and n = , participants for countries with more than mio. inhabitants (italy, germany, netherlands, poland). recruitment strategy complies with the need of having a fast data collection; therefore, most of the participants will be recruited via social platforms (e.g. facebook, twitter, instagram, whatsapp, linkedin). additional strategies will include recruitment through universities, stakeholders and professional organizations, and advertisements in television, newspapers and magazines. a range of different methods will be used to increase variability of the sample in terms of gender, age, education, and regions of the countries (e.g. posting on interest groups and websites that address different age, gender, and education groups). participants may or may not receive incentives, depending on the financial resources of the participating countries. the core set of instruments includes sociodemographic characteristics (e.g. age, gender, nationality, relationship status, education, income and work situation), risk and resilience factors and stressors related to the covid- pandemic, coping behaviours during the pandemic, symptoms of adjustment disorder, and symptoms of posttraumatic stress disorder. for the selection of risk and resilience factors and stressors, a conceptual framework on the determinants of mental health during the covid- pandemic has been developed (figure ), based on the who framework for social determinants of health (solar & irwin, ) . individual risk factors include age, gender, single-parent status, migration status, health worker (e.g. nurse, care assistant, front-line health worker), being at work with frequent personal contact, education, previous or current mental illness, and childhood trauma exposure, among others. childhood trauma exposure will be assessed using the first five items of the adverse childhood experiences (ace) questionnaire (felitti et al., ) . respondents are asked ('yes' vs. 'no') whether they experienced five different types of aces before age of (emotional, physical, and sexual abuse; emotional and physical neglect). the ace questionnaire has been validated in nonclinical and clinical samples and demonstrated satisfactory internal consistency and evidence for its convergent validity with the childhood trauma questionnaire (schmidt, narayan, atzl, rivera, & lieberman, ) . the remaining risk factors will be assessed by self-constructed items. perceived cognitive, behavioural, and emotional burden of covid-related stressors will be assessed with -point scales ( = not at all burdened, = somewhat burdened, = moderately burdened, = strongly burdened) during the last month. more specifically, we will assess stressors related to health (e.g. fear of contracting covid- , having covid- ; severity of covid- ; loved ones having covid- ; severity of covid- of loved ones, death of loved ones); public-life restrictions (e.g. restricted leisure activity, being at home most of the time); social relations (e.g. perceived lack of social support; restricted personal contact to loved ones; stigmatization); home (e.g. difficulties with combining work with childcare, conflicts at home; restricted housing conditions); work (e.g. financial and job loss, reduced working hours); and social media (e.g. consumption of social media coverage of the pandemic). risk and resilience factors and stressors on the country level, e.g. population demographics (density, age structure), public policies to respond to the covid- pandemic, the time of the outbreak, social security, healthcare system characteristics, and social policies will be collected from publicly available data sources (e.g. john hopkins coronavirus resource centre, centre for health security). to address all covid-related coping behaviours, a brief questionnaire on coping behaviour was specifically developed (pandemic coping scale, pcs; lotzin, ). the first set of items was developed by the university of hamburg, based on the recently published recommendations on how to cope with the covid- pandemic (ama, ; cdc, ; csts, ; who, ) , and on a review of studies about coping during previous pandemics. the resulting questionnaire includes items representing coping behaviour in six areas: preventive action (e.g. 'i have been following the recommendations to limit the spread of the coronavirus'); health lifestyle (e.g. 'i have been paying attention to a healthy diet.'); rest (e.g. 'i have been paying attention to take enough breaks.'); meaningful activities (e.g. 'i have been doing something that i enjoy.'); daily structure (e.g. 'i have been paying attention to maintain my daily routine.'); and social support (e.g. 'i have been spending a good time with loved ones, friends, or my pet.'). respondents rate on a -point-scale ranging from to ( = i have not been doing this at all; = i've been doing this a little bit; = i've been doing this a medium amount; = i've been doing this a lot) what best applies to them. items were constructed by a clinical psychologist with expertise in traumatic stress research and psychological treatment of posttraumatic stress disorders (first author of this protocol). items were then reviewed, refined and selected by consensus of an expert group of professionals in the field of traumatic stress (authors of this protocol). use of supportive services (telephone consultation, online coaching, psychotherapy or self-help group; personal coaching, psychotherapy or self-help group) during the pandemic will be also assessed. symptoms of adjustment disorder will be assessed with the adjustment disorder -new module (adnm- ; kazlauskas, gegieckaite, eimontas, zelviene, & maercker, ) . the adnm- measures adjustment disorder symptoms with eight items ranging from to ( = never, = rarely, = sometimes, = often). a total score (ranging from to ) can be calculated by summing up the item scores. the measure has been psychometrically evaluated in helpseeking individuals with symptoms of adjustment disorder, where it has indicated factorial validity (kazlauskas et al., ) . symptoms of posttraumatic stress disorder will be assessed using the primary care ptsd screen for dsm- (pc-ptsd- ; prins et al., ) . the pc-ptsd- is a brief -item screening measure for ptsd according to dsm- . respondents rate on dichotomous items whether the respective ptsd symptom was experienced within the last month ( = no, = yes). the total pc-ptsd- score is obtained by summing the scores of the five items. the pc-ptsd- has been developed from the ptsd- , a widely used screening measure for ptsd that showed reasonable performance characteristics in community settings (spoont et al., ) . the pc-ptsd- has demonstrated strong preliminary results for its diagnostic accuracy (prins et al., ) . in addition to the core set of measures described above, each participating country may include optional instruments to assess the following constructs: resilience, coping behaviours, symptoms of depression, and positive consequences of the covid- pandemic. resilience will be assessed using the resilience evaluation scale (res; van der meer et al., ) . the scale comprises nine items tapping self-confidence and self-efficacy. the participants indicate how they think about themselves and the way in which someone usually responds to difficult situations on a -point scale (from = completely disagree to = completely agree). in addition to the pandemic coping scale that measures the pandemic-specific coping behaviour, coping behaviours can be assessed using the brief cope (carver, ) . the brief cope is a multidimensional inventory to assess coping with distress. fourteen types of behaviours (self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioural disengagement, venting, positive reframing, planning, humour, acceptance, religion, self-blame) are measured by items on -point rating scales ( = i have not been doing this at all to = i've been doing this a lot). in addition to symptoms of adjustment disorder and posttraumatic stress disorder, symptoms of depression can be measured using the patient health questionnaire (phq- ; kroenke, spitzer, & williams, ) . respondents rate on nine items ( = not at all to = nearly every day) whether they experienced symptoms of fatigue, loss of appetite or negative thoughts related to depression within the last weeks. positive consequences due to the coronavirus pandemic can be assessed by a set of items developed for the purpose of this study. they ask the participants to indicate whether they see that the covid- pandemic may have had any positive aspects. the items are designed in a -point response format, ranging from 'not at all positive' to 'strongly positive'. these items cover the potentially positive consequences in the following areas: social, health, job, learning, joyful time, reflection, and recovery. the study was registered in a study registry prior to its start (osf registry, https://doi.org/ . /osf. io/ xhyg). participants are expected to be recruited from end of may to november . potential participants will receive an invitation to participate in the survey by providing a website link to the study. all eligible participants will be included in the study. participants will be asked to complete an online survey consisting of several questionnaires (see measurement section). participants will be contacted again after months and asked to participate in the survey for the second assessment point. to explore psychosocial reactions to the covid- pandemic across the ten european countries, descriptive statistics of the covid-related stressors, symptoms of adjustment disorder and posttraumatic stress disorder will be computed, stratified by country and relevant risk groups (e.g. health workers, elderly, low income). mean and standard deviation or median and interquartile range will be computed, as appropriate, for the continuous variables; absolute and relative frequencies will be computed for categorical variables. the prevalence of adjustment disorder (adnm- > ) and posttraumatic stress disorder (pc-ptsd > ) will be estimated for each timepoint with mixed logistic regression for the sample and for risk-groups (p-level %, two-sided). for examining the impact of risk and resilience factors and stressors on symptoms of adjustment disorder, we will apply a longitudinal multilevel model with the adjustment disorder symptom score (adnm- ) as dependent variable, all defined risk and resilience factors and stressors (see measures section) and time point (repeated measurement using a firstorder autoregressive covariance matrix) as independent variable. if the data will not follow a normal distribution, the data will be transformed with appropriate data transformation methods (e.g. linear square, cube root or logarithmic transformation, depending on the distribution of the skewed data) prior to data analysis (Šimkovic & träuble, ) . after a backward selection using a likelihood ratio test in each step, a final model with the most important determinants will be obtained. this model will be extended to a moderation model to examine the moderating effect of coping behaviour. to test the robustness of the results, missing values will be imputed using the full information maximum likelihood approach in a sensitivity analysis. the same procedure will be followed for examining the impact of risk and resilience factors and stressors on symptoms of posttraumatic stress disorder. in addition to the analysis described above using continuous scores, the presence (vs. absence) of adjustment disorder (adnm- > ) or posttraumatic stress disorder (pc-ptsd> ) will be used as a dependent variable for a secondary data analysis to examine the impact of risk and resilience factors and stressors on adjustment disorder. the study will meet all ethical regulations as required by the regulations of the ethics committees which are responsible for the respective study sites. each country will obtain ethical approval of the study on a national level. informed consent to participate in the study will be obtained from all participants. participants will be informed that they are under no obligation to participate and that they can withdraw at any time from the study without consequences. data will be stored on a server of the coordinating centre (centre for interdisciplinary addiction research, ciar, at university of hamburg), or on a secure server of the study site, depending on the country. data handling will follow the eu general data protection regulation (dsgvo); data will be stored for at least years. we will follow the strobe statement on good reporting practice. the results will be published in open access journals, following the guidelines on open access to scientific publications and research data in h . participant countries will retain the property and administration of their national data, and all countries will share the core dataset in order to enable analyses from the whole sample of the ten countries. after study completion and publication of the results of the primary study aims, data will be made available to the public. al designed the study in cooperation with the project steering committee formed by the representatives of the estss countries (all authors of this protocol). al, da, mb, mf-b, jdj, va, ek, bls, and is drafted the manuscript of the study protocol; all authors revised sections of the manuscript and approved the final version of the manuscript. margarida figueiredo-braga http://orcid.org/ - - - evaldas kazlauskas http://orcid.org/ - - - matthias knefel http://orcid.org/ - - - social determinants of mental health managing mental health during covid- covid- and the consequences of isolating the elderly. the lancet public health the psychological impact of quarantine and how to reduce it: rapid review of the evidence sustaining the well-being of healthcare personnel during coronavirus and other infectious disease outbreaks profile of a killer: the complex biology powering the coronavirus pandemic relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. the adverse childhood experiences (ace) study the consequences of the covid- pandemic on mental health and implications for clinical practice lifetime traumatic stressors and adverse childhood experiences uniquely predict concurrent ptsd, complex ptsd, and dissociative subtype of ptsd symptoms whereas recent adult non-traumatic stressors do not: results from an online survey study the mental health consequences of covid- and physical distancing: the need for prevention and early intervention mental health problems and social media exposure during covid- outbreak managing mental health challenges faced by healthcare workers during covid- pandemic multidisciplinary research priorities for the covid- pandemic: a call for action for mental health science trauma-informed responses in addressing public mental health consequences of the covid- pandemic: position paper of the european society for traumatic stress studies (estss) impact on mental health and perceptions of psychological care among medical and nursing staff in wuhan during the novel coronavirus disease outbreak: a cross-sectional study a brief measure of the international classification of diseases- adjustment disorder: investigation of psychometric properties in an adult help-seeking sample rising from the ashes: affirming the spirit of courage, community resilience, compassion and caring the phq- : validity of a brief depression severity measure factors associated with mental health outcomes among health care workers exposed to coronavirus disease the emotional impact of coronavirus -ncov clinical features of covid- in elderly patients: a comparison with young and middle-aged patients pandemic coping scale. unpublished manuscript predictive factors of psychological disorder development during recovery following sars outbreak the primary care ptsd screen for dsm- (pc-ptsd- ) national center for ptsd covid- and mental health: a review of the existing literature covid- pandemic and lockdown measures impact on mental health among the general population in italy. an n = web-based survey childhood maltreatment on the adverse childhood experiences (aces) scale versus the childhood trauma questionnaire (ctq) in a perinatal sample robustness of statistical methods when measure is affected by ceiling and/or floor effect a conceptual framework for action on the social determinants of health assessing psychological resilience: development and psychometric properties of the english and dutch version of the resilience evaluation scale (res) world health organization (who). ( ). mental health and psychosocial considerations during the covid- outbreak risk factors of icd- adjustment disorder in the lithuanian general population exposed to life stressors the authors thank the study personnel and collaborators for their support: irina zrnic (team austria); prof. tanja franciskovic and helena bakic (team croatia); ilaria cinieri, alessandra gallo and chiara marangio (team italia); monika kvedaraite (team lithuania); lonneke lenferink (team netherlands); monika folkierska-Żukowska and magdalena skrodzka (team poland); aida dias (team portugal); dr filip arnberg, dr josefin sveen, dr kerstin bergh johannesson and ida hensler (team sweden).we greatly thank the study team of the coordinating site at university of hamburg (team germany) that prepared the questionnaires, in particular laura kenntemich, who was supported by lennart schwierzke and laura gutewort. we also would like to thank dr sven buth and eike neumann-runde for their technical support in the setup of the survey. special thanks are due to zoran sukovic for his continuous organizational support as secretary of estss. the authors declare that the research was conducted in the absence of any commercial or financial interests that could be perceived as a potential conflict of interest. the authors did not receive specific funding for the planning of this research or for the preparation of this study protocol. key: cord- -b rucgmg authors: di carlo, francesco; sociali, antonella; picutti, elena; pettorruso, mauro; vellante, federica; verrastro, valeria; martinotti, giovanni; di giannantonio, massimo title: telepsychiatry and other cutting edge technologies in covid‐ pandemic: bridging the distance in mental health assistance date: - - journal: int j clin pract doi: . /ijcp. sha: doc_id: cord_uid: b rucgmg at the end of a novel coronavirus (covid‐ ) was identified in china. the high potential of human to human transmission led to subsequent covid‐ global pandemic. public health strategies including reduced social contact and lockdown have been adopted in many countries. nonetheless, social distancing and isolation could also represent risk factors for mental disorders, resulting in loneliness, reduced social support and under‐detection of mental health needs. along with this, social distancing determines a relevant obstacle for direct access to psychiatric care services. the pandemic generates the urgent need for integrating technology into innovative models of mental healthcare. in this paper we discuss the potential role of telepsychiatry and other cutting‐edge technologies in the management of mental health assistance. we narratively review the literature to examine advantages and risks related to the extensive application of these new therapeutic settings, along with the possible limitations and ethical concerns. telemental health services may be particularly feasible and appropriate for the support of patients, family members and health‐care providers during this covid‐ pandemic. the integration of telepsychiatry with other technological innovations (e.g., mobile apps, virtual reality, big data and artificial intelligence) opens up interesting future perspectives for the improvement of mental health assistance. telepsychiatry is a promising and growing way to deliver mental health services but is still underused. the covid‐ pandemic may serve as an opportunity to introduce and promote, among numerous mental health professionals, the knowledge of the possibilities offered by the digital era. initially identified in december in china, the coronavirus disease is now affecting more than countries and territories around the world. given the current unavailability of an effective cure or vaccine for covid- , a public health strategy of reduced social contact and distancing has been adopted worldwide to slow the spread of the virus. this strategy may on the one hand achieve its goals, but on the other hand, it may undermine normal social support systems, yielding to loneliness and reduced support from family and friends. these conditions may be risk factors for the development of anxiety, stress, depressive symptoms [ ] [ ] [ ] [ ] in the general population, they may worsen previously diagnosed diseases [ ] , as well as they may favor the onset of new problematic behaviors (e.g., internet misuse [ , ] ). during the pandemic ni y. m. et al. ( ) found that almost one-fifth of respondents to their online survey, targeting chinese adults, reported probable anxiety and depression. another survey, carried out in the same time among italian people, registered high/very high levels of depression, anxiety and stress in a large part of the sample [ ] . because of the contagiousness of covid- [ ] , physical access to the mental health care system could increase the risk of infection. fear of contracting the disease in a healthcare setting, transportation restrictions and isolation at home have become important barriers to treatment for many people [ ] . zohu et al ( ) reported that the decrease of hospital visits led to a reduction of routine psychiatric care for many patients with mental disorders in china, during the covid- outbreak. consequently, . % of their sample self-reduced drugs dosages and . % stopped taking their psychiatric drugs because they could not have a prescription from their doctor. they also found out that . % of new patients with anxiety disorders, insomnia, psychosis or depression, could not receive timely diagnoses and treatment during this period. these data globally underline the urgency of quickly adapting to current situation, in order to guarantee continuity of care for at-risk populations, such as that of psychiatric patients. in this respect, the global concern about the psychosocial consequences of covid- pandemic has led governments to call for suggestions to deal with these effects. the use of digital health technology has been proposed as an important strategy to reinforce heath systems [ ] . this article is protected by copyright. all rights reserved according to the world health organization, telemedicine is "the delivery of health care services, where distance is a critical factor, by all health care professionals, using information and communication technologies" [ ] . when applied in the field of psychiatry these methods are known as telepsychiatry (tp). telemental health services can be particularly useful and appropriate for the support of both patients and health care workers during this pandemic, allowing providing assistance and care to those who need it by reducing the risk of infection. illustrative of that is the case of a californian psychiatric clinic in which all patients with existing appointments received care via tp, allowing to provide uninterrupted care while minimizing potential covid- exposure to patients and clinicians [ ] . technology-based tools offer telemedicine visits for patients, as well as support for institutions, by facilitating the provision of information and data sharing, while creating virtual spaces for meetings and clinical briefings [ ] . it is interesting to underline that psychiatric care is relatively unique: with only rare exceptions, psychiatrists are not expected to physically touch their patients to provide the best services. verbal and visual assessments, which can easily occur via telemedicine, are all that is needed to engage with patients appropriately obtain full diagnostic accuracy and provide most types of treatments. this makes using a -way tele-videoconferencing for clinical assessments and treatment delivery a reasonable method for psychiatric treatment [ ] . the aim of this narrative review is to evaluate tp utility and feasibility, updating and summarizing the most important findings about its use in the modern psychiatric practice, in order to inform the potential use of tp during the pandemic. this article is protected by copyright. all rights reserved pandemic. only english-written papers were considered for inclusion. resources were filtered using abstracts (where available), before evaluating full texts, and the included studies were selected based on their relevance to the aim of this review. the reference section of each examined article was also reviewed to identify other potential studies. a total of records was found from bibliographic search. of these, record were excluded after abstract evaluation (n= because were not english written, n= because were other study types, n= because were not relevant to the aim of this review). of for patients, tp improves access to care, reduces appointments' waiting time and decreases travel time and costs [ ] . some patients report feeling more comfortable, and can be more open and honest, when discussing difficult subjects from their devices, because the virtual space of the session instills a feeling of "protection". another important advantage of tp in terms of rapport building is the possibility for patients (especially immigrants, refugees, and asylum seekers) to receive psychiatric assistance in their native language without the assistance of an interpreter [ ] . in their review cowan et al. [ ] reported several advantages to tp, both from the patient's and the clinician's points of view. by working in different settings (schools, prisons, homes, and hospitals) and with different populations (prisoners, students, employees, hospital patients and outpatients) clinicians can have flexibility in scheduling appointments and an increased diversity of practice. they may also feel safer when this article is protected by copyright. all rights reserved evaluating patients without any risk of physical aggression. furthermore, the use of tp allows clinicians to remotely consult other colleagues. given a reasonable initial apprehension, discomfort and fear, patients generally report an increase in comfort and satisfaction after having used tp a few times. comparably to patients, after a few trials, clinicians reveal an improved attitude toward tp as well, suggesting that increased exposure for clinicians may be important to alleviate their concerns about rapport [ ] . with regards to efficacy, in a recent narrative review by hilty et al. [ ] , tp was found to be effective in terms of patient acceptance, ability to increase access to care and provision of good educational outcomes. moreover, tp was found to be valid and reliable when compared to in-person services. telemental health effectiveness compared to faceto-face treatment has been proven in various randomized controlled trials (rct). this has been proved to be valid also for psychotherapy. [ ] [ ] [ ] . both users and, particularly, nonusers of telemedicine reported disliking the loss of personal contact with patients. the decreased ability to detect nonverbal cues during video conferencing may limit the building of the relationship, since clinicians report some difficulties in picking up nuances and emotions [ ] . some clinicians may feel and look clumsy and uncomfortable or may have a hard time engaging with patients; eye contact can feel artificial across the screen as well. clinicians have also expressed discomfort in being unable to take physical actions to reassure or assist their patients [ ] . when randomly assigned to evaluate in-person vs videoconference therapy sessions psychiatrists reported lower therapeutic alliance in telemental health settings; they also persisted on being hesitant to use video conference for their therapy sessions because they believed that the therapeutic alliance was at risk [ ] . concerns have been voiced about certain patients possibly being non-suitable for tp, including individuals with psychotic symptoms, acute crisis or at risk of self-harm [ ] . patients with auditive, visual or cognitive impairments appear not to be eligible for telemental health services [ ] . furthermore, it has been proposed to carefully consider the role of substance abuse and past episodes of self-injurious or violent behavior before selecting a patient for a tp intervention [ ] . technical difficulties such as transmission unable to start, spontaneous this article is protected by copyright. all rights reserved disconnections, poor audio/visual quality and audio/visual delay may seriously affect the tp session. sound quality may affect more substantially the interaction; although audio quality may be prioritized, poor visual transmission, resulting in decreased ability to detect nonverbal cues, remains a concern [ ] . clinicians are often reluctant to try tp because it is not something they are accustomed to [ ] . new approaches to professional techniques require deliberate conscious efforts. there are deep-rooted cultural traditions in medicine that impede the diffusion of tp. physical proximity has an important part in clinical practice, with an enormous cultural significance. over the course of two thousand years, a doctor's physical presence has been regarded as necessary for clinical practice and patients' healing. telemental health is not equally distributed among professional categories other than psychiatrists. for example, more than two-thirds of psychologists in the us have never used videoconferencing to deliver their therapeutic services in [ ] . finally, despite easier and cheaper access to the internet the so called "digital divide" remains often reported in the literature and can impede tp diffusion [ ] . these reports still reveal that the elderly, racial/ethnic minorities, and individuals from lower socioeconomic classes continue to trail behind in access to the internet and thus in taking advantage of tp opportunities [ ] . to address this limitation the lancet commission on global mental health recommended adoption of digital interventions alongside traditional in-person treatments, rather than as replacements [ ] . a relevant concern about using tp is privacy. it is important to ensure conversations' confidentiality and to protect health information and sensitive data. another confidentiality issue is of technological nature, concerning network security and encryption [ ] ; in fact, videoconferencing occurs through the internet connection, it is therefore essential to guarantee that the meeting will not be easily hacked into, or viewed by others [ ] . clinicians and organizations who are supplying telemental health services must adapt their connection pathways and equipment to the health information protection laws, such as the usa's health insurance portability and accountability act (hipaa). in recent years a variety of platforms (like zoom, bluejeans, simplepractice and others) have been developed with opportune security and confidentiality [ ] , but privacy cannot be this article is protected by copyright. all rights reserved guaranteed in its entirety. in fact, the fbi warned about the weakness of such platforms after some unidentified users invaded several school-sessions, a phenomenon called "zoombombing". because of the covid- pandemic, some governments have issued an emergency waiver suspending the requirement to comply with information protection laws, as it happened in the usa for hippa, in order to facilitate access to telemedicine services [ ] . however, the privacy issue remains a compelling one. similar with in-person interventions, clinicians are legally obligated to seek informed consent and review possible risks and benefits of the treatment [ ] . nittari et al. [ ] recently reviewed legal issues related to informed consent, data protection, confidentiality, physician's malpractice, and liability in telemedicine. the main issue reported by the authors is the global uncertainty of the legislation in the field. it has been suggested that clinicians need to update their knowledge and adapt to the newest regulations related to online interventions [ ] . tp has been proven to be valid and reliable in a variety of psychiatric disorders. depression is one of the most studied, and the evidence supporting the treatment of depressive disorders via tp is robust [ ] . a large number of systematic reviews and meta-analyses have examined technology-based interventions for depression, but only few of those have attempted to synthesize the data with the purpose of determining the admissibility and influencing factors of the implementation of tp [ ] . there are different forms of internet-delivered treatments for depression. one approach, based on bibliotherapy and the therapist's guidance via email or phone, uses primarily text-based materials. there are also short treatments that are not generally delivered with guidance and do not usually target people with clinical depression; although they can reach more people at a lower cost, they do so with a presumably diminished effect [ ] . globally, it seems that computerized treatments, administered with the support of a therapist, are much more effective than the unsupported ones, and that is confirmed in many open studies [ ] . patients with depressive disorders have been shown to benefit from tp, as reported by several studies in which patients' symptoms improved more in the telemental health group than in the traditional setting ones. a study evidenced how patients taking this article is protected by copyright. all rights reserved antidepressant in a high-intensity telemedicine-based collaborative care model reported less drug-related side effects than the low-intensity practice-based collaborative care patients [ ] . evidence from several studies has underlined that the use of tp for delivering mental healthcare services can improve symptoms of depression among older adults. the effects are the reduction of depression symptoms and the improvement of comorbid health conditions. a review analyzed the combination of tp with mobile apps targeting depression, anxiety disorders and substance abuse, reporting similar results [ ] . stanmore et al., in a meta-analytic review, showed that tp improves not only the patient's global cognition score, but also his/her cognitive functioning, which is often affected in depressive disorders [ ] . in pruitt and colleagues assessed patients' satisfaction in a group of military personnel with depression , who were included in a randomized clinical trial that utilized a type of psychotherapy known as behavioral activation therapy for depression (batd); this was delivered in-office and at home by videoconferencing [ ] . they discovered that patients' satisfaction was very high, with no significant difference between the two modalities, which is indicative of a comparable quality of care, and a satisfying level of contrary to popular belief, higher levels of end-of-treatment satisfaction for in-person care were detected to be mostly associated with younger age patients. conversely, the satisfaction for in-home care was more frequently associated with older and symptomatic individuals. plausible explanations for such results include stigma, symptom severity and convenience. younger patients, or those with less debilitating symptoms, may be more satisfied with traditional care treatments, while the elderly, or more symptomatic patients, may prefer a home-based care setting [ ] . it has been proposed that telemental health strategies could be a useful resource in the treatment of patients with obsessive compulsive disorder (ocd). with this kind of this article is protected by copyright. all rights reserved patients several barriers to treatment, such as logistic and financial barriers, as well as shame and fear of stigmatization or discrimination [ ] , could lead to the customary long delay from the onset of the disorder to the first treatment delivery [ ] ; telemental health therapies have the potential to overcome these barriers [ ] . in their extensive review videoconference-based cbt. all these approaches were based on the cbt principles. therapists' level of involvement ranged from direct contact through video or phone, to completely automated computer programs with no direct involvement. all telemental health interventions resulted in a decrease in ocd symptoms for active participants. they observed that the most efficient studies included contact with the therapist (higher effect size and lower dropout rate), although approaches that did not include visual or the use of tp has been tested in patients with schizophrenia as well. in their review, kasckow et al. [ ] summarized many studies involving telephone-based, internet-based and videoconference-based interventions and concluded that tp approaches were feasible with this kind of patients and that they could improve treatment outcomes. tp may help to engage these patients, to improve their medication adherence rates, to detect the exacerbation of psychotic symptoms and to prevent hospitalizations; nonetheless, only a strong patient-clinician engagement seems to guarantee an improvement in clinical and social functioning and an adequate relapse prevention [ ] . patients with schizophrenia exhibited high satisfaction levels when using telepsychiatry approaches; in fact, many patients reported feeling more comfortable using tp methods to connect with their psychiatrist and, additionally, anonymous web-based interventions may help them reduce stigmatization feelings. this article is protected by copyright. all rights reserved prompts related to follow up appointments, hygiene, physical exercise, symptom management and supporting messages [ ] . psychotherapy is now the front line, gold standard treatment for common mental health disorders in evidence-based medicine [ ] . yet, due to barriers including access, cost and stigma, estimates suggest that up to two-thirds of individuals do not access or receive evidence-based care [ ] . tp could help overcome those barriers. herbst et al. [ ] showed how, in a population of patients, an internet-based, therapist-guided cbt with exposure and response prevention led to significant reductions in the main symptoms of ocd; they also observed that this improvement remained stable throughout the -month follow-up period after treatment. the i-cbt did not inhibit a solid patient-therapist working alliance; in fact, a strong and stable patienttherapist relation was established [ ] . matsumoto et al. [ ] examined the feasibility of videoconference-delivered cbt in adult patients with mild to severe ocd, panic disorder (pd) and social anxiety disorder (sad). they determined that there was a significant reduction in symptoms for each group, with a remission rate of % for ocd, % for pd and % for sad. the therapeutic alliance significantly improved throughout the treatment and its scores were comparable to those of in-person cbt. the dropout rate was very low ( %), since % of patients completed the videoconference-delivered cbt treatment. interestingly, % of the participants affirmed to prefer videoconferencedelivered cbt to face-to-face cbt. additionally to tele-health services, in recent years digital technologies have found other secondly, the applications of virtual reality (vr) are very promising for the mental health field. vr is defined as a computer-generated simulation, a set of computer generated images and sounds, representing a place or situation with which the person can interact utilizing special electronic equipment [ ] . immersion in vr allows the patient to savor emotions he has already experienced in the real world, yet also to face dysfunctional behaviors and traumatic situations in a safe setting. it allows each individual to act as the protagonist and to regain control of his actions, to feel as the active builder of his own experience and, over time, of the changes he brings into his own life [ ] . the best applications of vr are found in ptsd, specific phobias, body-image disorders, such as nervous anorexia, and autism spectrum disorders. finally, today psychiatrists have the unprecedented opportunity to benefit from the use of artificial intelligence (ai) and, more specifically, of machine learning. this technique allows the clinicians to analyze huge amounts of data with the aim of producing a biologically founded re-classification of major psychiatric disorders. increasing evidence suggests that the sub-classifications obtained from machine learning data analysis have better predictive power of treatment outcome than the traditional dsm/icd models. in a new era of evidence-based psychiatry these objectively measurable transdiagnostic endophenotypes will allow the clinicians to make an early diagnosis, to individualize treatment and to make therapeutic adjustments to reduce disease relapses that are tailored for each individual. this has been called computational psychiatry [ ] . covid- pandemic brought to reduced social contact and impeded face-to-face interactions, also in delivering psychiatric assistance. the purpose of this paper was to review our knowledge about tp to inform its use during this pandemic, still lacking original studies addressing this topic. as shown, many are the advantages of tp, such as this article is protected by copyright. all rights reserved an improved access to care, the possibility for patients to receive psychiatric assistance in their native language, a reduction of travel time and costs and a comparable effectiveness to in-person care [ ] . however, is also important to consider some limitations of telehealth. first of all, more studies are needed to ensure a broader and more reliable validation of tp, in terms of diagnostic reliability and therapeutic efficiency in the short and long term. secondly, it is necessary to consider that tp is not suitable for all patients. moreover, some concerns remain about tp use during acute crisis: important cues such as facial expressions, tone and posture can be missed in the tp consultation. for this reason, there must be regular screenings for adverse events and a procedure for crisis intervention must be readily available [ ] . an important recommendation is to connect with on-site staff who may intervene if necessary [ ] . the privacy issue is also not to be underestimated: patients should be educated about personal privacy problems rising from using tp services outside the traditional clinical setting, like when speaking in rooms where family members can hear the conversation, or in public places where anyone might listen [ ] . the clinician himself must maintain privacy rules and ensure that no one will interrupt the session [ ] . despite the advantages and the technological progress tp is globally underused: in , only about % of psychiatrists in the united states had used tp [ ] . a recent article examining a large population of subjects from to concluded that, although telemedicine care had substantially increased during that time, its use was still not widespread in [ ] . in addition, in , the same clinicians accounted for more than half of all tele-mental health visits that year [ ] , suggesting that tp practice had been undertaken by very few, selected clinicians. during this pandemic period several authors all over the world underlined the need to promote online mental health care services and encourage their use [ , , ] . in fact, tp can capably respond to the mental health needs of people in isolation or quarantine, reducing infection risk. tp observes social distancing, avoids care interruptions and increases public health outcomes [ ] . considering that psychiatric population is more vulnerable to stress than general population, a disruption in care is concerning as it may increase the risk of symptom exacerbation and relapse. tp is precious to ensure continuity of care for these populations at higher risk of decompensation [ ] . in this regard, recently the us centers for medicare and medicaid services waived restrictions this article is protected by copyright. all rights reserved on originating sites for telehealth [ ] and the ability of healthcare professionals to prescribe remotely has been expanded to cover controlled substances [ ] . in china, in addition, artificial intelligence programs have been used as interventions for psychological crises during the pandemic. furthermore, online psychological counselling services have been widely established -h services on all days of the week [ ] . considering the experiences from past serious virus pandemics, improvement of mental health care are needed [ ] . the increasing demand for psychiatric services in the overburdened mental health care system presents a risk of creating a global public mental health crisis throughout the world [ ] . despite initial difficulties to adapt the system to tp requirements, this crisis can be an opportunity to improve the healthcare system and to expand its accessibility for patients also for the future [ ] . the review here presented has some limitations. mainly, it has been conducted in a narrative way and using only one electronic database to search for articles. this decision has been undertaken in order to rapidly review the literature to inform the unfolding pandemic situation, but possibly limited the number of references obtained. there is the need for future research to investigate the topic in a systematic way, in order to rigorously assess the contribution of tp in covid- pandemic. focused and continuous trainings of clinicians are required to increase the awareness of the benefits and risks of tp. in relation to this, and considering the present pandemic, formally teaching tp in medical schools, residency trainings and continuing medical education programs should be encouraged. among other benefits, this may be a way to help cultural acceptance of tp both among patients and medical staff. in conclusion, tp is destined to expand in the future and mental health professionals have a strategic role to help ensure that these technologies respect the therapeutic relationship and remain rigorous in their scientific foundation. accepted article mental health, risk factors, and social media use during the covid- epidemic and cordon sanitaire among the community and health professionals in wuhan, china: cross-sectional survey mental health consequences during the initial stage of the coronavirus pandemic (covid- ) in spain epidemic of covid- in 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to covid- -moving toward st century access to care the role of telehealth in reducing the mental health burden from covid- telemental health in the context of a pandemic: the covid- experience available from: accepted article this article is protected by copyright dea okays telehealth to prescribe opioids amid covid- emergency online mental health services in china during the covid- outbreak. the lancet psychiatry timely mental health care for the novel coronavirus outbreak is urgently needed. the lancet psychiatry impact of human disasters and covid- pandemic on mental health: potential of digital psychiatry ijcp_ _f .pdf key: cord- -po br zm authors: wang, gan-yi; tang, shang-feng title: perceived psychosocial health and its sociodemographic correlates in times of the covid- pandemic: a community-based online study in china date: - - journal: infect dis poverty doi: . /s - - - sha: doc_id: cord_uid: po br zm background: coronavirus disease (covid- ) pandemic has been affecting people's psychosocial health and well-being through various complex pathways. the present study aims to investigate the perceived psychosocial health and its sociodemographic correlates among chinese community-dwelling residents. methods: this cross-sectional survey was carried out online and using a structured questionnaire during april . in total, men and women with the age range of – years from eight provinces in eastern, central and western china were included in the analysis. we adopted a tactical approach to capture three key domains of perceived psychosocial health that are more likely to occur during a pandemic including hopelessness, loneliness, and depression. multiple regression method, binary logistic regression model and variance inflation factor (vif) were used to conduct data analysis. results: respectively . %, . % and . % of the participants expressed feeling more hopeless, lonely, and depressed during the pandemic. the percentage of all three indicators was comparatively higher among women than among men: hopelessness ( . % vs . %), loneliness ( . % vs . %), and depression ( . % vs . %). being married was associated with lower odds of loneliness among men (odds ratio [or] = . , % ci: . – . ). loneliness was negatively associated with smoking (or = . , % ci: . – . ) and positively associated with drinking (or = . , % ci: . – . ). compared with those in the lowest income bracket (< cny ), men (or = . , % ci: . – . ) and women (or = . , % ci: . – . ) in the highest level of annually housed income (> cny ) had the lowest odds of reporting perceived hopelessness (or = . , % ci: . – . ). smoking also showed negative association with depression only among men (or = . , % ci: . – . ). conclusions: more than one-third of the participants reported worsening in the experience of hopelessness and loneliness, with more than two-fifth of worsening depression during the pandemic compared with before the outbreak. several socioeconomic and lifestyle factors were found to be associated with the outcome variables, most notably participants' marital status, household income, smoking, alcohol drinking, existing chronic conditions. these findings may be of significance to treat patients and help them recover from the pandemic. the world health organization declared the coronavirus disease (covid- ) outbreak as a public health emergency of international concern (pheic) on january , [ ] . countries around the world have soon responded to the emergency through the adoption of various strategies to contain the outbreak such as cessation of local and international travels, foreclosure of non-essential businesses, home quarantine for at-risk population, and strict physical distancing [ ] . the drastic changes in social and personal aspects of daily living are resulting in considerable degrees of psychosocial distress [ ] [ ] [ ] . based on the relevant review, the probability of related psychological problems has been significantly increased due to the uncertainty and fear associated with the epidemic, as well as the large-scale blockade and economic recession. in this context, even with the world's most advanced health care system, there are inherent difficulties in providing such a wide range of psychological care [ ] . as china was one of the worst-hit areas, a series of assessments on the psychological state of residents were conducted in the early stage of the epidemic. the country has been struggling to meet the mental healthcare needs of the population. although the country has been able to achieve considerable progress in terms of promoting its mental healthcare infrastructure and service delivery system, evidence suggests that the prevalence of population with psychological conditions has been increasing. unhealthy lifestyle behavior, sociocultural environment, and demographic structure are the commonly cited factors that are fueling the mental health crisis. notably, the necessity for maintaining constant physical distancing has most certainly deepened social isolation and inadequate community adhesion in a society where loneliness is already a grave concern among mental healthcare providers. even among people who having the capable of maintaining adequate networking and having a healthy social life are being forced to self-isolate themselves from their beloved ones driven by the fear of cross-transmission of the virus. this is especially for frontline workers such as those involved in the healthcare and retail industry. china is among the most highly urbanized countries in asia, with nearly two-thirds of the population residing in the ever-expanding cities. the country has shown a strong resolution to fight urban poverty so far. however, pockets of poverty-ridden communities are still common who are now being the hardest-hit by the economic repercussions of the pandemic [ ] [ ] [ ] . a great majority of the urban population are directly employed in the laborintensive industries, and they are at risk of falling into poverty. the compounding effect of loss of income and the adverse health outcomes can be identified as a key contributor to the perceived psychosocial situation of the population. for low-income earning individuals and families, loss of income can translate to catastrophic expenditures even when it comes to affording basic commodities. several researches have been published so far illustrating the psychosocial health consequences of economic poverty among children and the general population in china [ , ] . in addition to the financial impact, the prolonged pandemic is affecting psychosocial well-being, for example, disruption in routine lifestyle, alterations in the environmental factors that are driving unhealthy behaviors such as less physical activity, higher scopes for smoking and drinking, inadequate supply of fresh and nutritious food, and longer screen-time and more addictive social media use among the younger population. they have been shown to be the negative association associated with mental health outcomes [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the elderly population need higher dependency and physical and emotional care, especially for those with chronic health conditions, lack of psychologically supportive environment and caregiving can lead to feelings of hopelessness and loneliness [ ] [ ] [ ] [ ] . china's growing segment of the elderly population and the capacity of the healthcare system to meet their special physical and mental healthcare needs are rising concerns among health policymakers and researchers. since the outbreak of the pandemic, several research studies have been published regarding the mental health issues among the chinese population [ , [ ] [ ] [ ] . however, the findings are still mixed, and the use of different domains of mental health and their measurement techniques make their generalization and contextual interpretation challenging for scholars. in this study, we adopted a tactical approach to capture three core domains of mental health that are more likely to occur during the pandemic and relate them to several proximal and distal factors to understand the relative contrasting contribution to each of the three constructs. prevalence of covid- on april , , the top two provinces and lower one province based on the number of cases were selected from each region. therefore, hubei, hunan, and shanxi provinces were selected from central china, and guangdong, zhejiang, and fujian provinces were selected from eastern china. due to the similarities in local conditions and customs between sichuan and chongqing, only one of those two provinces were chosen with a comparatively higher prevalence in western china. according to the comprehensive influence of the city in each province, the provincial capital and another city were selected in each province. sixty households from both rural and urban households in one city and all households aged over ten years were invited to participate in the online survey. a total of residents from households in provinces ( cities) were surveyed. due to the low response of residents in guangdong and zhejiang provinces, only half of the households attended the survey. data collection was conducted from april to april of , a project manager in each province was recruited to coordinate provincial survey training. six local investigators were recruited according to their annual household income in each local city to send online questionnaires and control the quality of investigation process. half of them were from urban areas and most were college students. after receiving training in online data collection, each investigator was asked to send online questionnaires to local families on their social network, including friends, relatives, native classmates, and so on. each eligible family member was invited to fill out an online questionnaire (powered by www.wjx.cn) on an average of min. a secret gift was sent to encourage the participants to complete the submission through the wechat . . (tencent computer system co. ltd. shenzhen, china). due to the limitations of objective factors such as age, education level, and space distance, residents may lose the ability to participate in the online survey. it was suggested to invite the young offspring living together to answer the questions according to their choice. if there was difficulty in investigating the surrounding families, a supplementary survey was carried out by other investigator to complete the remaining household survey. meanwhile, the follow-up investigation of quality control measures was taken during the data collection process. ( ) conducted a preliminary survey, group, and trained the investigators. ( ) each researcher was independent, but the relationship between students at different learning stages were allowed in this investigation. ( ) before distributing the online questionnaire, the eligible family numbers of each household were used to generate a unique questionnaire number. ( ) questionnaires for each family were sent out. they investigators were asked to convey a message: "those who carefully complete the questionnaire will receive a secret gift." furthermore, many trap questions were set in the questionnaire to identify people who did not answer the questions carefully. ( ) the project manager checked the quality of each questionnaire according to the threshold value of survey time exceeding s and the consistency of the two groups of questions set in the questionnaire. in this study, we adopted a tactical approach to capture three key domains of psychosocial health that are more likely to occur during a pandemic including hopelessness, loneliness, and depression. the first outcome variable is perceived hopelessness, which is a commonly construct used in population-based studies as an indicator of psychosocial well-being such as depression and suicide [ , ] . it has been studied in the context of predicts general health and social functioning among the population with mood disorders, showing the wider applicability of this construct in the context of psychological well-being. in this study, it was measured by the question: would you say since the beginning of the pandemic you have been feeling hopeless: same as before, little worse than before, far worse than before. hopelessness is associated with increases in the risk of emotional maladjustment and a range of negative mood states, both in the general population and clinical settings [ ] . the second outcome variable is perceived loneliness, which is measured by the question: would you say since the beginning of the pandemic you have been feeling lonely? same as before, little worse than before, far worse than before. loneliness is widely a prevalent phenomenon globally and has been a popular topic of research across various domains including chronic health conditions, psychological stress, and anxiety [ ] . loneliness is a common human emotion that is linked to feeling of insecurity, vulnerability, and isolation and is also associated with overall morbidity and mortality in adult populations. although there is no universally agreed definition of loneliness, it is generally understood as not just being alone, but perceived feeling of lack of an attachment figure, social network, and absence of a circle of people that allows an individual to develop a sense of belonging, of company, of being part of a community [ , ] . the third outcome variable is perceived depression which is measured by the question: would you say since the beginning of the pandemic you have been feeling depressed? same as before, little worse than before, far worse than before. a single-item measure of self-rated depression (srd) is being used increasingly population-based health survey for its ease of application and high sensitivity to objectively measured health outcome including all-cause mortality among cognitively intact community-dwelling older adults [ ] . one-item question for measuring general health condition is increasingly used in epidemiologic survey [ ] , and measure by questions like: "in general, would you say your mental health is: excellent, very good, good, fair or poor?" [ ] explanatory variables included: age ( - , - , - , - , - , - , - , +); sex (male/ female); marital status (not married/married); annual household income (< cny , cny - , cny - , cny - , cny > ); occupation (white-collar/blue-collar/student and unemployed); smoker (no/yes); alcohol consumer (no/yes); has any chronic conditions (no/yes); residency (urban/rural); provinces/municipality (hunan, hubei, shanxi, chongqing, gansu, fujian, zhejiang, guangdong). data analyses were performed using stata version (statacorp, texas, usa). the prevalence of the sample population reporting hopelessness, loneliness, and depression was presented as percentages. following that, the relationship between the three outcome and explanatory variables was measured by multivariable regression methods. given the dichotomous nature of the outcome variables, a binary logistic regression model was used to generate the odds ratios (or) and their % confidence intervals (ci). the variance inflation factor (vif) was used as a measure of collinearity to ensure that none of the predictor variables in the final model was highly associated with each other. all statistical tests were two-tailed and p values below . were considered statistically significant. the protocol was reviewed and the ethical approval was obtained from the ethics committee of tongji medical college, huazhong university of science and technology ( s ). the oral informed consent was obtained from each participant before taking the online survey. a total of residents over the age of years old completed the survey, of which were eligible. the participation ratio was . % ( / ), and the valid participation ratio was . % ( / ). basic demographic characteristics and the prevalence of reporting hopelessness, loneliness, and depression were presented in table . respectively . %, . %, and . % of the participants expressed feeling more hopeless, lonely, and depressed during the pandemic. the percentage of all three indicators was comparatively higher among women than among men: hopelessness ( . % vs . %), loneliness ( . % vs . %), and depression ( . % vs . %). as shown in fig. , men were less likely to report same level of hopelessness ( . % vs . %), loneliness ( . % vs . %), and depression ( . % vs . %) during the pandemic than before compared with women. more than half of the women reported having a higher level of hopelessness ( . %), loneliness ( . %), and depression ( . %) during the pandemic than before. factors associated with perceived psychosocial health were presented in table . in general, compared with those in the youngest age group ( - years), those in the higher age groups had relatively higher odds of reporting hopelessness, loneliness, and depression. however, these associations reversed for those in the higher age groups of - and + years old. participants who were employed in blue-collar jobs, as well as those with no job or studying, had higher odds of reporting hopelessness and depression. in terms of hopelessness, the association with occupation was significant among men (or = . , % ci: . - . ). in terms of depression, the association with occupation was significant among women (or = . , % ci: . - . ). smoking was negatively associated with loneliness (or = . , % ci: . - . ), but it was negatively associated with depression only among men (or = . , % ci: . - . ). however, the positive association with drinking was also found (or = . , % ci: . - . ). having ncds was associated with higher odds of reporting loneliness among men (or = . , % ci: . - . ), and of reporting depression both among men more than one-third of the participants reported worsening in the experience of hopelessness and loneliness, with more than two-fifth of worsening depression during the pandemic compared with the time before. notably, the percentage of the perceived hopelessness, loneliness, and depression was comparatively higher among women than among men, implying that gender-gradient in the vulnerability to mental health implications of the pandemic. there is a growing volume of literature on mental health repercussions of the pandemic, but the sex-differences in mental health-related outcomes are not very clear. however, the prevalence of psychological disorders, especially that of major depressive disorders has been found to be higher among women in previous study [ ] . in the context of covid- , women might be at higher risk of poor mental health outcomes due to issues related to increased incidence of intimate partner violence (ipv) and loss of livelihood. besides, women who are pregnant and experiencing difficulties in receiving routine antenatal care may experience psychological challenges that are being ignored by themselves and their caregivers. unfortunately, these potential factors such as pregnancy, quality of marriage were not included in this study. therefore, it recommends that future research should underscore these issues to better understand the sex-disparity in mental health outcomes from covid- . this study also revealed that the exacerbation of experience of hopelessness, loneliness, and depression are correlated with a range of sociodemographic and economic factors. we found that participants in the higher age groups had relatively higher odds of reporting hopelessness, loneliness, and depression, except for those in the oldest age groups ( + years), in whom the association was reversed. in general, this study show that being married, living in a high-income family, and working in a white-collar job all have protective effects on these three outcomes. expectedly, we found a strong positive association between reporting hopelessness and household income. the current body of literature provided evidence of the physical and psychological morbidities resulting from financial constraints [ , ] , and a handful of studies briefly focused on the construct of hopelessness [ ] [ ] [ ] . the intersection between financial and mental well-being is mediated with the underlying benefits of material advantage. nonetheless, this result should be interpreted with caution since we had data only on raw income which may not be indicative of the actual financial situation of the participants. it was also worthy of noting that household income didn't show any significant association with loneliness and depression. while the link between socioeconomic status and mental health is relatively clear, our findings enrich the literature by showing contrastingly that annual housed income are more likely to be correlated with a sense of hopelessness. regarding health and health related behavior, we found that tobacco smoking was negatively associated with loneliness and depression, while drinking was positively associated with loneliness. several studies have so far discussed that the use of both smoking and drinking are being triggered by the psychosocial stress resulting from the pandemic [ , , , ] . having ncds was also found to be associated with higher odds of reporting loneliness and depression both among men and women. in china, ncds represent a major contributor to mental health related morbidities and mortalities especially among the elderly population [ ] [ ] [ ] , and the current situation is likely to be further aggravating given the higher susceptibility of the elderly population to covid- infection. while the healthcare system is being overstrained with covid- patients, the mental healthcare needs of people with chronic diseases should be given special priority at the same time. lastly, the participants in the urban areas had higher odds of perceived psychosocial health, indicating that the urban population share a higher susceptibility to psychological stressors compared with their rural counterparts. the underlying reasons behind this urban-rural difference might be rooted in factors such as population density and relative risk of cross-transmission, differences in the type of employment, and availability of essential goods and services. in light of the above, it is important to provide the necessary mental health support [ ] . we recommend the active and ongoing participation of mental health professionals in policy task forces during this critical period [ ] .to meet the needs of the general population during this pandemic, it is necessary to consider online or smartphone-based psychosocial education to promote mental health and psychological interventions [ , ] , such as cognitive behavioral therapy (cbt) and mindfulness-based cognitive therapy (mbct). mbct focuses on the use of various mindfulness meditation exercises to develop a sense of right and wrong judgment and is particularly helpful in relieving stress in people with poor physical conditions. in addition, online platforms are well suited to isolating people and can be a way for people to offer support to each other, sharing their challenges and solutions during an outbreak to ease their anxiety and depression [ ] . the sample size of this cross-sectional survey was relatively large and included participants with a broad age range. one important aspect of the study is the contrasting measurement of the outcome factors before and during the pandemic. this method of subjective measures of mental health status is relatively simpler and yet captures important information regarding the change in the situation specific to the pandemic. it should be kept in mind that this method doesn't reflect whether or not people were in sound mental health status prior to the pandemic, but rather the shift which can be used effectively in other crisis settings such as natural disasters. our results should be interpreted with caution because of several limitations. first, the data is cross-sectional and the associations cannot indicate causality. second, or odds ratio, ci confidence interval level of significance: *p < . , **p < . , ***p < . . the items in the brackets were the referred subgroups the conclusions cannot be generalized to the entire population of china due to inadequate sample size. third, data was self-reported, and therefore the chance of reporting bias cannot be ignored. we were also unable to include these potential factors such as pregnancy and spousal relationships which are likely to be associated with the outcome variables among women. also, the financial situation was not measured as a subjective assessment of solvency, which could have given a better reflection of the association between material wealth and psychological health. findings showed that more than one-third of the participants reported worsening in the experience of hopelessness and loneliness, with more than two-fifth of worsening depression during the pandemic compared with the time before, with the percentage of all three indicators being comparatively higher among women than among men. several socioeconomic and lifestyle factors were found to be associated with the outcome variables, most notably participants' marital status, household income, smoking, alcohol drinking, existing chronic conditions. although the data are cross-sectional and hence no causal inference can be made of the associations, our study makes an important contribution to the current literature regarding the mental health situation among the population who are not directly affected by the pandemic, but among the healthy and community-dwelling population. these findings will help to understand the sociodemographic groups sharing a higher susceptibility to psychosocial stress arising from the pandemic and design proper intervention strategies. world health organization declares global emergency: a review of the novel coronavirus (covid- the mental health consequences of covid- and physical distancing the need for prevention and early intervention effects of covid- lockdown on lifestyle behaviors in children with obesity living in verona, italy: a longitudinal study impact of covid- pandemic on children and 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recommended and excessive preventive behaviors during the covid- pandemic: a community-based online survey in china the health perceptions and misconceptions regarding covid- : spreading mechanism and elimination strategy in china mental health strategies to combat the psychological impact of coronavirus disease (covid- ) beyond paranoia and panic publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we would like to acknowledge the phd bishwajit ghose, jia-wei zhou and fang-fei chen at huazhong university of science and technology for their assistance in the manuscript construct and manuscript revision. st was responsible for collecting the data, drafted the outline of this study, performed data management, and revised the manuscript. gw performed the data analysis and drafted the first manuscript. all authors read and approved the final manuscript. st received funding from the fundamental research funds for the central universities at https ://www.hust.edu.cn/ (grant no: kfyxgyj ). the funders had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscript. the datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. the ethical approval was obtained from the ethics committee of tongji medical college, huazhong university of science and technology ( s ). the oral informed consent was obtained from each participant before taking the online survey. not applicable. the authors declare that they have no competing interests. key: cord- -nlui d e authors: zahn, matthew; adalja, amesh a; auwaerter, paul g; edelson, paul j; hansen, gail r; hynes, noreen a; jezek, amanda; macarthur, rodger d; manabe, yukari c; mcgoodwin, colin; duchin, jeffrey s title: infectious diseases physicians: improving and protecting the public’s health: why equitable compensation is critical date: - - journal: clin infect dis doi: . /cid/ciy sha: doc_id: cord_uid: nlui d e infectious diseases (id) physicians play a crucial role in public health in a variety of settings. unfortunately, much of this work is undercompensated despite the proven efficacy of public health interventions such as hospital acquired infection prevention, antimicrobial stewardship, disease surveillance, and outbreak response. the lack of compensation makes it difficult to attract the best and the brightest to the field of id, threatening the future of the id workforce. here, we examine compensation data for id physicians compared to their value in population and public health settings and suggest policy recommendations to address the pay disparities that exist between cognitive and procedural specialties that prevent more medical students and residents from entering the field. all id physicians should take an active role in promoting the value of the subspecialty to policymakers and influencers as well as trainees. in recent decades, emerging and reemerging infectious diseases (id) have caused outbreaks with national and international implications and have underscored the critical need for id expertise. id physicians do more than protect the health of their patients. due to the unique communicable nature of id, id physicians provide a population-level service by helping to secure the health of the community. however, as id threats to public health continue to emerge, the number of young physicians applying for id subspecialty training continues to wane. id physicians lead public health responses in their healthcare facilities and communities and at federal and global levels. in the last decades, id specialists have played vital roles in responding to emerging diseases and epidemics including west nile virus ( ), severe acute respiratory syndrome (sars; ), h n pandemic influenza ( ), middle east respiratory syndrome (mers; and ongoing), ebola virus ( - and ongoing), and zika virus ( and ongoing). while these outbreaks garner a great deal of media visibility, id physicians also routinely detect, prevent, or mitigate community outbreaks of vaccine-preventable diseases, foodborne illness, and healthcare-associated infections. the work performed by id doctors in the united states is substantially undercompensated. id physician salaries average around $ a year less than other subspecialties [ , ] . young physicians, who generally complete training with substantial educational debt, can be driven from considering the field [ ] . developing a robust id workforce of the future requires a strategy to attract quality physicians and keep them engaged on the frontline of patient care, research, and public health. despite their documented value, id physicians' services are undervalued by payers compared to primary care and procedure-based specialties. a graduating trainee finishing an internal medicine residency can work immediately as a hospitalist at a higher mean salary than an id physician who will take to additional years of fellowship training. such variances in compensation for direct patient care and insufficient pay for value in other roles such as infection control creates a significant disincentive to pursuing a career in id. the medscape physician compensation report reveals that the median salary of a specialty physician to be approximately $ per year [ ] . the infectious diseases society of america's (idsa) compensation survey showed that the average id physician earns about $ a year. full-time public health physicians averaged $ per year less [ ]. the average medical student leaves school with approximately $ in debt [ ] . this financial disincentive is a significant contributor to the . % decline in the number of applicants to id fellowship training programs over the -year period ending in [ ] . only . % of these programs filled through the match, down % over the same period [ ] . while the - match saw an improvement in the number of positions filled, the match rate was still significantly below that of other specialties, many of which customarily fill at or near % [ ] . it is essential that id physicians promote the value this subspecialty brings to public health in order to affect the policy changes necessary to secure the future of the field. here, we provide concrete examples of id physicians' unique contributions to public health, which can be used to educate policymakers and influencers at the federal, state, and local levels and to advocate for needed investments to sustain the field. id specialty preparation consists of training first in general adult internal medicine or pediatrics followed by to years of training in id. the id subspecialty fellowship includes integrated training to provide patient care and ensure population health. the clinical training includes diagnosis, management, and treatment of patients with id; expertise in techniques for preventing healthcare-associated infections and antimicrobial resistance; prevention strategies; and research approaches to address id-related questions. in , id physicians were practicing in the united states [ ] , often combining clinical care with work as educators, epidemiologists, public health leaders, antimicrobial stewardship or infection prevention and control directors, researchers, administrators, and policymakers. multiple studies have demonstrated the cost-effectiveness and patient benefit of id physician care for hospitalized patients with id [ ] [ ] [ ] [ ] . further, the work of id physicians provides broader public protection against infectious threats through community and healthcare facility-based infection control and prevention activities, surveillance, outbreak response, and other public health activities. the id workforce plays a critical role in managing infections such as human immunodeficiency virus (hiv), tuberculosis, and viral hepatitis, which can cause community outbreaks if not promptly diagnosed and treated. the public health workforce, including id physicians, has been shrinking over the last decade [ , ] . these workforce losses pose a significant barrier to carrying out routine public health activities and responding to public health threats. id physicians employed by federal agencies and state health departments have the community as their patient. along with id physicians in other practice settings, they provide leadership and subject matter expertise to enable a wide variety of community-based interventions. for example, id management and prevention. public health strategies to contain the spread of hiv rely on ensuring that people living with hiv-aids have access to id-driven clinical care. by achieving sustained virologic suppression, people stay healthy and reduce the risk of community transmission [ ] . the hiv and hepatitis c virus (hcv) outbreaks linked to injection drug use in rural scott county, indiana, serve as a stark reminder of the risk for rapid disease transmission in communities that lack robust outbreak prevention resources and activities [ ] . in there was an outbreak of hepatitis a virus in the homeless population of san diego, california, that required significant work from the public health community to resolve [ ] . in march , a national academies of medicine panel declared the elimination of hepatitis b and hcv in the united states by to be a feasible goal. a sufficient workforce with the expertise to treat patients with hcv will be critical to reaching this goal [ ] . as an example of outbreak detection and response to emerging infections, the indiana state health department recognized the first identified case of mers in the united states in a traveler to that state. id specialists at the department helped develop and implement protocols to ensure appropriate care, prevent the spread of infection, and avert an outbreak. id physicians working inside or outside of public health often provide guidance to help allocate community vaccine resources and other preventive services. for example, during measles outbreaks in california in and minnesota in , id physicians within the state and local health departments helped lead vaccination campaigns to halt the spread of the disease [ , ] . even in the absence of a major outbreak, patients in hospitals and healthy individuals in communities are potentially exposed to increasingly drug-resistant and difficult-to-treat pathogens, necessitating id physician leadership to protect the population by limiting the spread of infectious threats [ ] . id public health physicians act as a trusted resource, working through the media, to help educate the public about communicable diseases and prevention strategies. current topics of concern include multidrug-resistant bacteria, zika virus outbreaks, the hepatitis a outbreak in san diego, and mycobacterium chimera infections in patients treated with heart-lung bypass machines. infection prevention and control activities in healthcare settings involve a range of interventions. methods include providing oversight of programs that conduct surveillance and identify risks, providing education regarding the use of appropriate isolation procedures and personal protective equipment, developing policies to respond to novel infections, and ensuring that the healthcare environment and medical devices are properly cleaned and maintained. studies have shown that development and implementation of these activities by id physicians have resulted in improved outcomes and reductions in hospital-acquired infections in a variety of healthcare settings [ ] . prevention of healthcare-associated infections leads to savings of approximately $ to more than $ per patient depending on the specific infection in a variety of healthcare settings [ ] . examples of id physician leadership in infection control and prevention and healthcare epidemiology are described here. during the west africa ebola crisis in and , id physicians served as leaders of special biocontainment units at the national institutes of health, university of nebraska, emory university, and bellevue hospital. these units and their staff developed novel, sophisticated infection prevention strategies to care for patients with potentially deadly infections. they reassured medical providers, political leaders, and our nation's public by providing safe, state-of-the-art care. in seattle, washington, an id physician reported an outbreak of deadly, multidrug-resistant carbapenem-resistant enterobacteriaceae infections were attributed to contaminated, faulty duodenoscopes. this investigation helped lead to changes in guidance on endoscope reprocessing and safety [ , ] . an id physician at vanderbilt university identified contaminated steroids as the source of a fungal meningitis outbreak that ultimately caused more than infections and deaths across states before the cause was established [ , ] . antimicrobial resistance is one of the most urgent public health threats of our time. infections caused by antimicrobial-resistant organisms kill more than people and result in $ billion in unnecessary healthcare costs each year in the united states [ ] . newer antimicrobials will be precious resources, and id physician-driven expertise will be vital to ensure that they are being used appropriately. a recent clinical infectious diseases article highlighted the unique skill set and training id physicians have to lead antimicrobial stewardship programs (asps) in order to ensure that correct antimicrobials are used judiciously [ ] . the centers for disease control and prevention (cdc) have acknowledged the impact and importance of asps in their release of the core elements of hospital antibiotic stewardship programs in [ ] , and the joint commission released their antimicrobial stewardship standard for healthcare settings in . in , legislation was passed in california that mandated that every acute care hospital in the state establish a physician-supervised asp [ ] . adoption of a federal government requirement that other states follow suit would help to ensure that all patients can benefit from the positive impact of asps. asps will become increasingly vital in preventing a post-antibiotic era where common infections become untreatable due to resistant organisms. id physicians need to take an active role in ensuring their facilities have adequate asps that meet the standards laid out by the cdc and joint commission. well-run asps not only help preserve the efficacy of antimicrobials but also improve patient outcomes. in fact, studies have indicated that asps generated several hundred thousand dollars a year in cost savings while also reducing rates of clostridium difficile infections [ , ] . it is vital that the government continue to support the implementation of id-led asps in all healthcare settings to slow the development of resistance and to keep our current antimicrobials useful for as long as possible. in response to the anthrax bioterrorism attacks and the looming threat of pandemic influenza, hospitals began extensive preparations for natural and human-made bioemergencies. these activities substantially increased with the appearance of the sars, mers-coronavirus, and ebola virus epidemics. id physicians provided scientific and clinical expertise that shaped prevention, control, detection, and treatment efforts. natural disasters also carry an increased risk of outbreaks of unusual, serious infections, as seen in connection with the hurricanes and flooding in texas, florida, puerto rico, and the us virgin islands, which led to more than reported cases of leptospirosis and other waterborne and vectorborne diseases [ ] . id physicians also played a leading role in infection prevention at large-scale shelters for people who had been displaced by storms and flooding. hospital and healthcare system emergency preparedness requires an intimate knowledge of hospital infection control procedures and capacities, regional collaboration with other facilities, planning with public health authorities, and development of communication strategies within the hospital community, with public health departments, and with the general public. a review of recent international id outbreaks emphasizes the global dimensions of public health protection-the sars epidemic originated in hong kong, the ebola virus outbreak started in west africa, and the zika virus epidemic spread from brazil throughout south america and the caribbean. a bacterial plasmid that conferred resistance to colistin, often the last antimicrobial line of defense against gram-negative organisms, emerged from bacteria that were colonizing domestic animal populations in china and is now seen in patients on continents. older epidemics, of course, continue; tuberculosis and hiv-aids remain scourges in many countries. emerging and reemerging infections with global consequences have reemphasized efforts to address global health security. the global sars epidemic illustrated how increased international travel and trade introduce new risks for the rapid worldwide spread of new infectious pathogens. the world health organization international health regulations (ihr), issued in , were officially adopted by countries [ ] . id physicians remain crucial to ongoing ihr implementation efforts, including disease outbreak recognition, in-country training, and collaborative partnership in epidemic disease control, diagnostics, and preparedness. with prescient timing, the cdc' s global health security agenda (ghsa) was launched just months before the ebola crisis surfaced in west africa. the ghsa aims to "accelerate progress toward a world safe and secure from infectious disease threats; to promote global health security as an international priority and to spur progress toward full implementation of who ihr " [ ] . the goals fall into major themes: prevention, detection, and response. id physicians provide critical support to all arms. id training and expertise establish the necessary foundations for the prevention goal to address issues such as antimicrobial resistance, biosafety and biosecurity, and immunization needs. the detection goal promotes innovation in the area of accurate, real-time, cost-effective id diagnostics. greater use of diagnostic tests in countries currently lacking such resources is critical for containing emerging and reemerging infections, preventing outbreaks, and halting the development of antimicrobial resistance. the response goal would establish emergency operations centers that link public health with other rapid-response agencies, all of which draw on id physician expertise. multiple studies have demonstrated that consulting an id physician improves treatment outcomes and lowers patient care costs. this benefit has been documented for id consultation in general [ ] , in specific patient populations such as intensive care unit patients [ ] , and for specific illnesses such as staphylococcal bloodstream infections and other multidrug-resistant organism infections [ , ] . id physicians also improve outcomes and reduce costs through antimicrobial stewardship and infection prevention [ , ] . in addition, many complex procedures and treatments (such as bone marrow and solid organ transplantation) could not be safely conducted without input from id specialists. the idsa has implemented several initiatives in an effort to reinvigorate the pipeline of id applicants. these include mentorship programs; scholarships for medical students, residents, and fellows interested in id; research and clinical career meetings; and medical school id interest groups. however, other potential options should be considered in order to properly compensate id physicians for the public health benefit of their work. recommendations for federal, state, local, and institutional policymakers include the following: establish loan repayment opportunities for id physicians who work in public service (eg, local, state, or federal public health departments). significant medical school debt can drive new physicians away from the id specialty and public health. targeted loan repayment opportunities would allow more physicians to pursue these critical career paths. in july , in a move supported by idsa, the us house of representative's energy and commerce committee passed legislation that would authorize the cdc to provide loan repayment for those who serve in the epidemic intelligence services (eis). more than % of eis officers continue serving in public health roles, and this proposal would significantly help make this career path more financially feasible for physicians. such loan forgiveness opportunities could also be broadened to support id physicians who work in public health at the federal, state, or local level and face similar challenges around compensation and medical student debt. establish financial compensation for id physicians who work in public service (eg, local, state, and federal public health agencies) or who do id work that provides broader public health benefits (infection control and antimicrobial stewardship). physicians who perform infection control and antimicrobial stewardship work should be compensated for these activities. as part of hospital accreditation, the centers for medicare and medicaid services (cms) mandates that every participating facility have an active infection control program [ ] . states could attach an accreditation process to such mandates that would formally document id clinicians who oversee hospital infection control and antimicrobial stewardship committees, with loan forgiveness or other financial incentives attached to this accreditation. ensure that id physician compensation reflects public health value added. as a cognitive specialty, many of the clinical services id physicians provide are billed under evaluation and management codes, which have not been reevaluated in more than years. the cms should update these codes to reflect the increasingly complex care provided in inpatient and outpatient settings. public and private payers, healthcare systems, and hospitals should also provide appropriate compensation and protected time for nonclinical services that are crucial to public health, including infection prevention and control, antimicrobial stewardship, and bioemergency preparedness and response. fully fund local, state, federal, and global public health agencies and build a competent workforce. without proper workforce funding, including funding of id physician positions, health departments will not be able to hire and retain the expert workforce necessary to detect, prevent, and respond to public health threats. appropriate compensation for id service in all of these forms will have significant positive effects on individual patient care, nosocomial infections, and community public health, ensuring that the future id workforce has enough of an incentive to pursue this vital field. medscape physician compensation survey results and data, specialties matching service, appointment year. national resident matching program appointment year. national resident matching program association of american medical colleges physician specialty data book employing infectious disease physicians affects clinical and economic outcomes in regional hospitals: evidence from a population-based study the value of an infectious diseases specialist the value of infectious diseases specialists: non-patient care activities infectious diseases consultation reduces -day and -year all-cause mortality for multidrug-resistant organism infections a mismatch between the educational pipeline and public health workforce: can it be reconciled? enumeration of the governmental public health workforce partner study group. sexual activity without condoms and risk of hiv transmission in serodifferent couples when the hivpositive partner is using suppressive antiretroviral therapy hiv infection linked to injection use of oxymorphone in indiana a national strategy for the elimination of hepatitis b and c: phase two report measles outbreak-california antibiotic resistance threats in the united states the value that infectious diseases physicians bring to the healthcare system health care-associated infections: a meta-analysis of costs and financial impact on the us health care system endoscopic retrograde cholangiopancreatography-associated ampc escherichia coli outbreak infections associated with reprocessed duodenoscopes doctor isolates cause in nationwide meningitis outbreak. vanderbilt magazine multistate outbreak of fungal meningitis case count infectious diseases society of america, pediatric infectious diseases society, and the society for healthcare epidemiology of america. infectious diseases physicians: leading the way in antimicrobial stewardship core elements of hospital antibiotic stewardship programs california senate bill no. clinical and economic outcomes of a prospective antimicrobial stewardship program an evaluation of the impact of antibiotic stewardship on reducing the use of high-risk antibiotics and its effect on the incidence of clostridium difficile infection in hospital settings world health organization. international health regulations. available at: www the global health security agenda infectious diseases specialty intervention is associated with decreased mortality and lower healthcare costs impact of regular collaboration between infectious diseases and critical care practitioners on antimicrobial utilization and patient outcome the value of infectious diseases consultation in staphylococcus aureus bacteremia the value that infectious diseases physicians bring to the healthcare system conditions of participation for hospitals potential conflicts of interest. all authors: no reported conflicts. all authors have submitted the icmje form for disclosure of potential conflicts of interest. conflicts that the editors consider relevant to the content of the manuscript have been disclosed. key: cord- -ts sfxx authors: yang, yang; su, yingying title: public voice via social media: role in cooperative governance during public health emergency date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: ts sfxx with the development of the internet, social networking sites have empowered the public to directly express their views about social issues and hence contribute to social change. as a new type of voice behavior, public voice on social media has aroused wide concern among scholars. however, why public voice is expressed and how it influences social development and betterment in times of public health emergencies remains unstudied. a key point is whether governments can take effective countermeasures when faced with public health emergencies. in such situation, public voice is of great significance in the formulation and implementation of coping policies. this qualitive study uses china’s health code policy under covid- to explore why the public performs voice behavior on social media and how this influences policy evolution and product innovation through cooperative governance. a stimulus-cognition-emotion-behavior model is established to explain public voice, indicating that it is influenced by cognitive processes and public emotions under policy stimulus. what is more, as a form of public participation in cooperative governance, public voice plays a significant role in promoting policy evolution and product innovation, and represents a useful form of cooperation with governments and enterprises to jointly maintain social stability under public health emergencies as a positive extra-role behavior, voice has attracted extensive interests from scholars and gained substantial attention in the organizational behavior literature [ ] [ ] [ ] . public voice is a new type of voice behavior that refers to the behavior of citizens who share opinions on social media to improve the social status quo or prevent harmful practices [ ] . as a pro-social behavior, public voice is vital for advancement and betterment of society [ ] , and it is believed that public voice plays an important role in the cooperative governance of government and other organizations (e.g., enterprises, non-profit organizations) under a public health emergency. considering that public participation in public administration and policy formulation is beneficial to government performance, governments attach much importance to the public's role in policy-making, especially in the areas of environmental governance, public health, and sustainable development [ ] [ ] [ ] [ ] . in the face of extraordinary development problems, such as economic recession, public opinion in policy-making is extremely important [ ] . thus, to ensure the timeliness and efficiency of policy in the case of public health emergencies, the value of public voice, along with technical support from enterprise, should not be underestimated. in the covid- epidemic, many governments have begun to cooperate with high-tech enterprises to formulate epidemic prevention and control policies such as the health code in china, covidwise in virginia, and corona-warn in germany [ ] [ ] [ ] [ ] . public voice on social media has effectively promoted the evolution of epidemic control policy and tracking applications developed by enterprises, making an outstanding contribution to social stability. thus, it is necessary to study public voice in public health emergencies in relation to the implementation of government policies and the promotion of enterprises' product innovation. public voice is also of great significance in further realizing cooperative governance. voice behavior refers to the extra-role interpersonal communication behavior in which organizational members actively make constructive suggestions to the organization for the purpose of improving work or organization status quo [ ] . previous studies on voice behavior have mainly focused on employee voice and customer voice within organizations; public voice in a broader context has received little attention. the importance of employee voice and customer voice for the sustainable development of enterprises suggests that the role of public voice in social improvement should not be underestimated, and is worthy of in-depth discussion [ ] . given that public voice can have wide ranging influence in terms of social change, this research focuses on its effect on the evolution of policy implemented under public health emergencies. public voice in public health emergencies has several important characteristics: first, the target of public voice is more extensive. the targets of employee voice and customer voice are employees inside the enterprise and customers who have cooperative relationships with the enterprise, respectively. they often offer advice to the enterprise as a single identity. however, for public voice, the target is the general public, who have dual identities as policy participants and enterprise customers. second, under cooperative governance, multiple subjects participate in policy-making, so the targets and content of public voice are also diverse. for example, voice to a government may relate to the implementation of policy, while that to an enterprise may focus on product improvement. third, the channels for public voice are more diverse. employees mainly voice to supervisors face-to-face or make suggestions through the internal social networks of an enterprise, and most customer voice occurs through the virtual community created by the enterprise. as social networking sites provide a more convenient platform for people to voice their concerns and make their voices heard, the public can voice through a variety of social networking sites [ ] . finally, the effect of public voice is more significant. public health emergencies prompt the public to respond to the policy more actively and provide timely feedback [ ] , which forces the governments and enterprises to absorb public opinion as soon as possible to improve policies and products. overall, research on public voice behavior is still in its infancy. the factors driving public voice and the mechanism of its action on government policies and enterprise product innovation are unclear. the purpose of this study is to address this gap and further explore the role of public voice in promoting cooperative governance under public health emergencies. the main contributions of this paper are threefold. first, it extends the literature on voice behavior. most studies on voice behavior have focused on employee voice and customer voice. under cooperative governance, the public is a participant in government policy as well as a customer of enterprises, yet the mechanisms for the influence of public voice on policy and product are not clear. this paper focuses on the dynamic role of public voice in policy-making and evolution and product innovation. second, it constructs a dynamic model of public voice to promote policy implementation under public health emergency. studies of public participation have mainly focused on its effect on environmental projects and decision, as public participation is seen as highly valuable and necessary to achieve the goal of environmental pollution control [ , , ] . however, the voice behavior of the public in the formulation and evolution of policies in public health emergencies is unknown. finally, this paper extends the literature on cooperative governance in a public health emergency and attaches more importance to the role of public voice in the process of collaborative. this research uses china's health code policy under covid- as an example. this is an epidemic prevention policy whose implementation relies on a health rating system developed by alibaba, tencent, and other firms. the system uses opaque algorithms and individuals' data, such as physical condition and contact with an infected person, to make judgments about the infection risk of system users [ ] . the system then generates a qr code corresponding to this risk level that is used as a passport. based on the evolution process of health code policy, this paper downloads comments about the health code policy to do research. this study uses the qualitative research method of grounded theory to explore the factors driving public voice and reveals the dynamic mechanism of its influence on policy formulation and product innovation. further, this research provides support for cooperative governance involving government, enterprises, and the public under public health emergencies. the concept of voice was first proposed by hirchman in the field of economics. it has been further developed in the field of organizational behavior [ ] . currently, voice behavior is divided into employee voice, customer voice, and public voice. most research on voice behavior has been in the field of organizational behavior and mainly aimed to explain employee voice within organizations. van dyne and lepine define employee voice behavior as a positive extra-role behavior focused on improving existing working methods and procedures through constructive suggestions; they emphasize the 'promoting' role of employee voice for the organization [ ] . van dyne et al. further expand the concept, pointing out that voice includes not only suggestions for improvement, but also concerns about the organization [ ] . on this basis, liang et al. clearly divide voice behavior into promotive voice and prohibitive voice [ ] . promotive voice refers to innovative ideas or suggestions put forward by employees to improve the overall operation of the organization, while prohibitive voice refers to employees' attention to work practices, and events and employee behaviors that are not conducive to the development of the organization [ ] . employee voice is widely considered a valuable and positive extra-role interpersonal communication behavior, a kind of organizational citizenship behavior that plays an important role in the team and organization. scholars have conducted in-depth research on the influential factors and outcome variables of employee voice. previous studies indicate that personal characteristics, leadership, and organizational climate can influence employee voice, which will be beneficial to organizational betterment [ , , [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . additionally, the approaches of employee voice are also optimized due to the development of the internet [ ] . with the aggravation of market competition, customer participation becomes crucial for the product and service innovation of enterprises, and enterprises have created brand virtual communities to gather customers' ideas and opinions. research on voice behavior has also expanded from the internal voice of the organization to the field of consumer behavior. on the connotation level, griffin and hauser regard customer requirements as customer voice, holding the view that customers would sort their needs according to importance and convey them to enterprises [ ] . enterprises can then develop new products based on customer requirements. lee et al. expand the connotation of customer voice and define it as a description of customers' needs and expectations or preferences and dislikes, including the pursuit of rights and interests, suggestions for new products and services, and complaints about previous use experience. earlier definitions of customer voice are based on customer needs, but with advances in research on employee voice within organizations, scholars have begun to redefine customer voice from the perspective of role orientation. ran and zhou clearly define customer voice as the extra-role communication behavior in which customers actively make suggestions or express opinions to improve the status of enterprises; this kind of behavior belongs to the category of customer citizenship behavior [ ] . at the dimension level, most previous studies on customer voice divide it into two categories: customer satisfaction and customer complaint [ ] . with the deepening of research, scholars find that customers not only express dissatisfaction regarding product and service providers, but also express satisfaction and praise, and make their own suggestions. therefore, with reference to the classification of employee voice by liang et al., customer voice can be divided into promotive voice and prohibitive voice [ ] . promotive voice refers to the innovative ideas and suggestions of customers regarding improvements to the efficiency of enterprises, while prohibitive voice refers to the expression of opinions on actual and potential problems within the products, services, or management of an enterprise that are harmful to the enterprise or its customers. as the input behavior of customers to enterprises, customer voice can urge enterprises to innovate products and services to meet the needs of customers, thus improving customer satisfaction and maintaining customer loyalty. it can also help enterprises correct errors, provide solutions to problems, and improve enterprise performance [ , ] . with the rapid development of social media, people can express their views on social issues more directly and conveniently, and research on voice behavior has been further extended to a broader social life context. public voice behavior refers to citizens sharing opinions on social media to improve their social status quo or prevent harmful practices. it is essentially a pro-social behavior [ ] . public voice channels have begun to focus on social media, because in the modern world, social media presents extensive information; people express their concern about education, security, the environment, work-life balance, and many other issues online. moreover, the diversity and openness of social media provides a broad platform for public expression. the public can conduct online voice behavior through third-party social media and public participation is increasing. however, research on public voice based on social media is still in its infancy and is uncommon. bhatti et al. explore the mechanism of the effect of individual moral identity and proactive personality on public promotive voice and prohibitive voice based on self-consistency theory [ ] . research on voice behavior as discussed above has several characteristics. first, the research field has shifted from intra-organization to a broader social background. second, the voice subjects present a change trend of 'employee-customer-public'. third, the targets of voice behavior change from organizational practice to general social phenomena. fourth, the form of voice presents the evolution trend of "face-to-face-virtual community-social media". citizen participation in the formulation and consultation of public policies is an important way to strengthen and support modern democracy [ ] . regarding the influence of public participation on policy, most research reveals extensive interest in environmental protection and pollution control, as public participation can help decision makers recognize public concern and demands, and handle environmental conflict in a more flexible manner [ , ] . fu and geng explore the influence of public participation and regulation compliance on 'green development' with panel data from provinces in china from to , finding that public participation can lead enterprises to improve compliance and thus promote green development [ ] . regional environmental quality (req) is a comprehensive indicator of emissions of waste gas, waste water, and waste solids, and its improvement requires coordination between governance and public participation. public participation can be coordinated with governance to effectively improve req effectively, and further promote the optimization of environmental governance system [ ] . the arrival of the internet era has changed the method of public participation. as a branch of e-government, e-participation has been widely examined by scholars. considering that public participation is a voluntary activity, whether the public is willing to participate is the decisive factor affecting the success of e-government platforms. scholars consider that in addition to demographic differences, willingness to use an e-participation system is affected by system technical factors, personal incentive factors, and social capital factors. based on the unified theory of acceptance and use of technology, planned behavior theory, social capital theory, and other information system theories, previous studies have explored the willingness of the public to use the e-community to participate in policy-making and provide strategic suggestions for governments to improve e-government platform [ , ] . product innovation is an important focus in the innovation research field and is key for enterprises to obtain sustainable competitive advantage. at present, there is no unified definition of product innovation in academia. katila and ahuja define it as change in design attributes-such as technology, appearance, quality, and structure-relative to the existing products of an enterprise. this is also known as technological innovation or design innovation [ ] . the organization for economic co-operation and development defines product innovation as the process leading to a new or significantly improved product or service [ ] . various scholars' definitions of product innovation, identify two aspects: entity product innovation and service-related innovation. according to the different degree of innovation, product innovation can be divided into radical innovation and incremental innovation [ ] . rapid change in the external environment drives enterprise innovation; enterprises can only achieve long-term development by constantly producing more competitive products according to the needs of users. as an external innovation resource, customer voice can be regarded as a gift given by users to enterprises to help them carry out product innovation based on the collective wisdom [ ] [ ] [ ] . customer voice provides valuable information for enterprises, which can help product designers and engineers to understand customers' needs and preferences, and turn them into key objectives of product improvement by making targeted adjustments to products and services to meet the needs of users [ ] . further, customer voice can help enterprises identify the product attributes to which customers pay most attention and focus on product improvement and new product development [ ] . governance refers to processes and structures in public decision making and may involve the participation of multiple agents, such as governments, corporations, and the public, with the aim of carrying out a public purpose that cannot be accomplished by single force [ ] . cooperative governance is not limited to formal government-initiated arrangements, but involves diverse kinds of multi-partner governance related to a wide range of fields [ ] . for example, because of the production of pollution, enterprises take the greatest responsibility for environment contamination control. however, as it is difficult for governance goals to be achieved through the actions of a single enterprise, so governance among enterprises is indispensable [ ] . with regard to cooperative governance among governments, zhang et al. find that superior government should supervise heterogeneous local governments and increase penalties for non-cooperative parties to improve the efficiency of haze pollution control [ ] . further, cooperative governance can provide guidance for participatory governance by the public [ ] . studies of cooperative governance involving public participation have focused on environmental governance and sustainable development. when making local energy decisions, local governments should be given more autonomy and sufficient capacity to strengthen public participation. what is more, public opinion ought to be taken into consideration when developing policy [ ] . studies show that policy-making style presents convergence to the cooperation among government, public and non-profit organizations. as the government may lack the necessary resources to deal with issues, they rely on other subjects to provide support to ensure policy utility [ ] . to summarize, there are several problems needing to be solved: first, research on public voice is not mature and more studies are needed to clarify its antecedents as well as its effects on policy implementation and social development. second, it is undeniable that the public plays a crucial role in environmental governance, but the role of public voice behavior in policy-making and implementation under public health emergencies is still unclear. third, the role played by public voice in cooperative governance and how this happens deserve exploration. at the beginning of , the outbreak of covid- brought great impact on people's life and work. in order to contain the spread of novel coronavirus and speed up the normalization of production and life, on february , yuhang first launched the yuhang health code. and on february , hangzhou launched the hangzhou health code to implement "green code, red code, yellow code" three-color code dynamic management [ ] . the implementation of this policy has aroused widespread concern of the people all over the country, and local governments have followed up and implemented a local version of code in few weeks [ ] . the implementation of health code policy is assisted by the qr rating health code system developed by alibaba, tencent, or other firms. when registering, individuals should provide their names, id numbers, phone numbers, and answer a series questions about physical health conditions and travel trajectory to get the initial rating [ ] . in addition, the rating changes according to individual real-time data, which consists of individuals' travel history, directly related health information, overall medical test results, and overall risk assessment from individuals' reports, information from gps (global positioning system), telecommunications supplier, consumption record, qr code usage record, etc. the system assesses individual's infection risk and generates green, yellow, or red codes according to individual's data [ ] . people with green codes have a very low probability to be infected and can move around freely, while people with yellow codes have a risk to be infected to some extent and should be quarantined for a week. people with red codes are at great risk of infection and need to be quarantined for weeks. during the quarantine, if people with yellow or red codes check in on the app every day, the codes will turn green at the end of quarantine periods. and if the real-time information shows that people with green codes have gone to a high-risk area or been in contact with an infected person, the code will turn yellow or red as well [ ] . up to august , the tencent health code covers a population of hundred million people, more than cities and counties, and more than villages in china, with a cumulative total of billion visits [ ] . with the evolution of the health code policy, the effective circulation of personnel from all over the country has met the needs of residents' normal life and enterprises' resumption of work and production. at present, residents only need to provide a real-time qr code generated in a mini-app embedded in alipay (alibaba, hangzhou, china) or wechat (tencent, shenzhen, china) to the guard, they can move around [ ] . in the health code policy implementation process, the high-tech enterprises not only provide technical support to develop the health code system, but also participate in the formulation of policy standards and establishment of policy platforms. for example, alibaba and tencent have been fully involved in the formulation of national standards for the personal health information code series [ , ] . besides, during this process, the public is actively voicing on the implementation and evolution of the health code policy as well as improvements of health code application on social media. in the official weibo of people's daily, tweets about the health code policy get plenty of comments and followers, most of which are advice for policy implementation and system improvement. for example, the tweet about the hangzhou health code has comments and , followers. the government press conference and reports about enterprises confirm the public voice does play an important role in the evolution and promotion of health code policy and the voice is fully considered and adopted by government and enterprises when making decisions. on the joint prevention and control conferences of covid- , the government spokespersons provided response to public concern and the governments also instructed local government and related enterprises to take measures to meet public voice. in addition, the enterprises responded to public voice as well. in the government affairs strategy conference, yuepeng qiu, vice president of tencent, said that they had updated the system more than times. this study adopts a dynamic research perspective, and takes the dynamic evolution of health codes policy as an example, focusing on exploring how public voice promoted the improvement of products by enterprises and the implementation of policies by the government under a public health emergency. the core of grounded theory emphasizes the process of collecting and analyzing original data. in the data collection stage, the researcher takes the evolution process of the health code policy as the time axis, and collects public comments under the official microblog of the people's daily as the research object. data analysis included the following stages: firstly, open coding is used to identify phenomena, define concepts, and discover categories from the original data. secondly, axial coding is carried out to further analyze to get the main category. thirdly, selective coding is used to find the core category, and systematically connect it with other categories to construct a logical relationship. in the whole coding process, researchers keep supplementing the material. finally, the selective coding is analyzed and theoretical construction is carried out, and the density, variation, and high integration of theoretical concepts are adjusted to form a theoretical framework. the qualitative analysis software nvivo . (qsr international, melbourne, australia) was used for the analysis of this study. open coding is to analyze the original data word by word, so as to summarize the initial concepts and categories in the original data. following the process of "tagging-conceptualizationcategorization", the researchers analyzed the collected data word by word and refined the semantics of the data to obtain the corresponding concepts and categories. examples are shown in table . it's much more convenient than running around to apply material this is not only efficient to reduce the burden of screening personnel, but also can record personal travel the purpose of axial coding is to explore the potential logical relationship between categories and develop main categories. this study classifies different categories according to their relationship at the conceptual level, and concludes eight main categories, which are divided into three classifications. the main categories and their corresponding classifications and relations are shown in table . there is a risk of information leakage when the product collects too much user information there is a risk of abuse of rights when enterprises assume part of government responsibilities on the basis of axial coding, selective coding excavates the core category from main categories and analyzes the connection relationship among them. as shown in figure , the dynamic mechanism of public voice behavior to promote policy implementation and evolution in public health emergencies is as follows: first, under the guidance of the government, enterprises participate in the development of policy and design products to assist policy implementation with advanced technologies. second, in response to the government policy, the public will use enterprise products in their daily life and work. and through judging whether the policy can effectively solve the current problems and guide the future development of the society to form the policy effectiveness perception. third, public's perception of the effectiveness of policies will trigger public emotions. different perceptions of policy effectiveness can lead to positive or negative emotions. then, emotions can induce public voice behavior, including voice for government policies and for enterprise products. finally, the government and enterprises will give feedback to the public voice and improve the policies and products accordingly. as a new external stimulus, the improved policies and products also have an impact on the public's perception of policy effectiveness, forming a dynamic mechanism of public suggestions to promote policy evolution and product innovation, as shown in figure . induce public voice behavior, including voice for government policies and for enterprise products. finally, the government and enterprises will give feedback to the public voice and improve the policies and products accordingly. as a new external stimulus, the improved policies and products also have an impact on the public's perception of policy effectiveness, forming a dynamic mechanism of public suggestions to promote policy evolution and product innovation, as shown in figure . based on the results of grounded theory and cognitive appraisal theory of emotion, this paper constructs a driving mechanism of public voice behavior: "stimulus-cognition-emotion-behavior" model. the model shows that there are causal relationships among cognition, emotion, and behavior. according to the cognitive appraisal theory of emotion, under the stimulation of external events, the external information obtained by individuals first enters the perceptual system for compilation and processing, forming specific cognitions. cognitions trigger the individual's emotional response, and finally produces specific behavioral tendency [ ] . based on the results of grounded theory and cognitive appraisal theory of emotion, this paper constructs a driving mechanism of public voice behavior: "stimulus-cognition-emotion-behavior" model. the model shows that there are causal relationships among cognition, emotion, and behavior. according to the cognitive appraisal theory of emotion, under the stimulation of external events, the external information obtained by individuals first enters the perceptual system for compilation and processing, forming specific cognitions. cognitions trigger the individual's emotional response, and finally produces specific behavioral tendency [ ] . public policy is the political and technical approach to solve problems, fundamentally, it is pragmatic [ ] . under the cooperative governance, the government is no longer the only decision-maker, but the main participant plays a guiding role [ ] . with the advent of the new internet era, the impact of big data, cloud computing, and other technologies on policy formulation and implementation cannot be ignored. first of all, the internet can optimize the link of policy-making, and the process of it can be completed with the help of the internet, thus making policy-making more efficient. secondly, big data can provide a wider range of data sources for policy evolution. through data mining and analysis, it can provide big data support for policy evolution, making policy formulation and implementation more reasonable. finally, the open data system can further broaden the channels for the public to participate in policy discussions and make policy-making more democratic. due to the immature application of big data by the government and lack of professional talents, enterprises are required to provide technical support. the technical support of enterprises is more important for the formulation of policies under public health emergencies. as public health emergencies tend to be urgent, destructive, and uncertain, putting forward higher requirements for the timeliness, scientificity, and effectiveness of policies. in this case, it is very necessary for the government to cooperate with enterprises to formulate policies. the government is responsible for policy formulation and implementation, while enterprises take technological advantages to provide products or services to assist policy implementation. according to the cognitive appraisal theory of emotion, when individuals encounter the external stimuli, they will experience two-stage cognitive appraisal processes: primary appraisal and secondary appraisal. in addition, through the appraisal, people can assess the relevance of external stimuli to themselves and whether the resources they have can cope with the situation [ ] . in public health emergencies, the policy launched by government-enterprise cooperation is an external stimulus for the public. additionally, public appraisal mainly focuses on whether the policy can achieve policy purpose and effectively solve specific public problems, that is, perceived policy effectiveness. under the policy stimulation, the public will use the cognitive system to make evolution of it [ ] . the perception of policy effectiveness reflects the individual's judgment of the correlation between the policy and himself and is an important way for policy to act on public behavior. a high level of perceived policy effectiveness indicates that the public believes the policy is beneficial to their daily life, while on the contrary, they consider that the policy has no significant positive impact or may pose a threat. policy is the action route or method to guide the current and future decision-making, and its role should not be limited to solving the current problems, but also should be instructive for future development of society [ ] . according to the results of analysis, the policy effectiveness in public health emergency includes crisis resolution and social normalization. in the case of public health emergencies, the first problem to be solved by policies is to reduce the adverse impact of emergencies, that is crisis resolution. on the premise that the crisis is under control, policies should also have effects of accelerating the social normalization and promoting economic recovery, that is, the social normalization function. taking the health code policy as an example, if the public thinks that the health code policy cannot effectively control the spread of covid- , or cannot speed up work resumption, the public's perceived effectiveness of health code policy will be low. otherwise, the perception will be high. emotions are the products of an individual's appraisal of the person-environment relationship and of great diagnostic value to help an individual identify what is important under a specific situation. additionally, emotions vary with the change of appraisals [ ] . the public's emotional response to policy is formed on the basis of perceived policy effectiveness. according to the cognitive appraisal theory of emotion, emotion intuitively shows the public's evolution of external stimulus perception, and its core is evaluative cognition. almost everything will stimulate people to produce emotion, no matter if it happens or not [ ] . however, emotion cannot be aroused by external stimulus directly; the appraisal process of relationship between person-environment is necessary to evoke emotion. when individuals are in a certain situation, they will evaluate it, be satisfied or dissatisfied, beneficial or harmful, and make corresponding emotional reactions [ ] . if perceived policy effectiveness is high, the public will have a positive emotion, or vice versa. taking the health code policy as an example, different perceptions of public policy effectiveness will stimulate different emotions. when the public perceive that the health code policy can effectively control the spread of covid- or accelerate economic recovery, they will generate positive emotions. otherwise, they will hold negative emotions. examples of comments about health code policy are as follows. comment : as i am from hubei province, i didn't go back to my hometown, so i couldn't enter the market for days. after having the health code, i entered the market for the first time without being stopped. it is easy to use and it's really convenient, give it a thumb up! comment : i'm in fuyang, and i'm not even allowed to go to my husband's hometown in the countryside. i haven't left fuyang for nearly a month. i haven't even gone to downtown or move around fuyang. what the hell is this code? i don't understand. i'm so angry! according to the cognitive appraisal theory of emotion, the cognition and appraisal of external environment will stimulate special emotions. then, the emotion will motivate coping behaviors to prevent harm or to improve the prospects for benefit [ ] . public voice behavior is generated under the influence of public emotions. according to cognitive appraisal theory of emotion, emotional response will lead to an individual's specific behavior tendency to regulate the emotion (emotion-focused coping) or change for the better the problem (problem-focused coping) [ ] . on the basis of the public perceived policy effectiveness, the emotional reaction is finally transformed into the driving force to improve the effectiveness of the policy, which urges the public to put forward a constructive voice or point out the problems existing in the policies and products. when the public believe the policy can effectively defuse the current crisis and benefit future development, they will hold positive emotions and employ behaviors that can maximize the policy benefits. however, when the public think that there are some defects in the process of policy implementation undermining the policy effectiveness, they will generate negative emotions and take actions to reduce potential harm. after analysis, it is found that public voice can be divided into two dimensions: policy voice and product voice. according to the content of voice, policy voice can be divided into policy evolution and policy implementation. policy evolution voice is promotive voice and usually occurs when the public is in positive emotion, referring to the public's suggestions on the promotion and unification of policies across the nation. policy implementation voice refers to the voice made by the public for the actual implementation process of policies. in a public health emergency, policy implementation voice is mainly in the form of pointing out defects in the process of policy implementation, and it usually happens when the public is in negative emotion. public voice on products can be divided into product utility and potential risk. product utility voice refers to the public's suggestions on improving product efficiency and it includes both promotive voice as well as prohibitive voice. while potential risk voice is prohibitive voice, referring to the public's concern about the negative effects caused by enterprise's products. the examples of the health code policy are shown below. comment : now in many provinces, the biggest problem is that people are not allowed to enter the community! not even people with health codes! this is too unreasonable! if a policy is made, it is to be implemented. what good is policy if the implementation problem at the grassroots level is not solved? comment : the health code really gives me a great convenience in my life. it's easy to go out with it. i hope it can be promoted nationwide. in conclusion, the formation process of public voice behavior conforms to the "stimulus-cognition-emotion-behavior" model of cognitive appraisal theory of emotion. policy stimulus leads to the public's cognition of the effectiveness of policy, which arouses public emotion response and further leads to public voice behavior. the formation and evolution of policy is a dynamic and continuous process. previous studies have paid more attention to the impact of public participation in the policy-making stage [ , ] . however, this study finds that after policies are made, public voice also has a great impact on the evolution and implementation of policies. based on the results of grounded analysis, this paper divides the process of policy evolution into three stages: policy formation, policy promotion, and policy optimization, and constructs a dynamic mechanism of public voice to promote policy evolution and product innovation, as shown in figure . the policy is formed in accordance with the rigorous policy-making process in order to solve specific public problems. as the output of the political system, the main function of policy is to solve social public problems effectively. as public health emergencies often pose a major threat to social security and public order, as well as the safety of citizens' lives and property, the policy under public health emergencies aims to resolve the crisis state timely and effectively and restore the normal life order as soon as possible [ ] . as an external stimulus, the formation of policies will lead to the public's perceived policy effectiveness. at this stage, citizens' cognition of policy effectiveness mainly focuses on crisis resolution. whether the policy can effectively alleviate the adverse impact of public health emergencies is an important factor affecting public emotion. when policy is implemented, the public will form the perception of whether the policy can resolve the crisis effectively. when perceived policy effectiveness is high, the public will have positive emotion and tend to conduct promotive voice. as the construction of national emergency management system follows the basic principles of "ability-standard" and "center of gravity down", the local government is in the front line when dealing with public health emergencies and bears the main responsibility. therefore, the policies under public health emergencies are often formulated by the local government, and the superior government selectively promotes the policies according to the evolution of the applicability. so the public will suggest to promote policy across the country if they think the policy is effective enough. besides, the public will provide promotive voice to improve product utility in a state of positive emotion. when the public perceive the policy is not effective enough, they will have negative emotion and tend to conduct a prohibitive voice. public health emergencies prevent policy-making from following a strictly procedural process. the government needs to complete the implementation of the policy in a limited time, and it is difficult to guarantee the implementation of the grassroots administrative staff in a short time [ ] . therefore, the prohibitive voice mainly focuses on pointing out the problems existing in the implementation of the policy at the grassroots level. in the policy formation stage, as the implementation of enterprise's product auxiliary policy, the public's requirements for its effectiveness are more stringent. therefore, the public will be more active in pointing out problems in the use of products. through the evolution and adoption of public voice, the government improves the policy and the policy is formed in accordance with the rigorous policy-making process in order to solve specific public problems. as the output of the political system, the main function of policy is to solve social public problems effectively. as public health emergencies often pose a major threat to social security and public order, as well as the safety of citizens' lives and property, the policy under public health emergencies aims to resolve the crisis state timely and effectively and restore the normal life order as soon as possible [ ] . as an external stimulus, the formation of policies will lead to the public's perceived policy effectiveness. at this stage, citizens' cognition of policy effectiveness mainly focuses on crisis resolution. whether the policy can effectively alleviate the adverse impact of public health emergencies is an important factor affecting public emotion. when policy is implemented, the public will form the perception of whether the policy can resolve the crisis effectively. when perceived policy effectiveness is high, the public will have positive emotion and tend to conduct promotive voice. as the construction of national emergency management system follows the basic principles of "ability-standard" and "center of gravity down", the local government is in the front line when dealing with public health emergencies and bears the main responsibility. therefore, the policies under public health emergencies are often formulated by the local government, and the superior government selectively promotes the policies according to the evolution of the applicability. so the public will suggest to promote policy across the country if they think the policy is effective enough. besides, the public will provide promotive voice to improve product utility in a state of positive emotion. when the public perceive the policy is not effective enough, they will have negative emotion and tend to conduct a prohibitive voice. public health emergencies prevent policy-making from following a strictly procedural process. the government needs to complete the implementation of the policy in a limited time, and it is difficult to guarantee the implementation of the grassroots administrative staff in a short time [ ] . therefore, the prohibitive voice mainly focuses on pointing out the problems existing in the implementation of the policy at the grassroots level. in the policy formation stage, as the implementation of enterprise's product auxiliary policy, the public's requirements for its effectiveness are more stringent. therefore, the public will be more active in pointing out problems in the use of products. through the evolution and adoption of public voice, the government improves the policy and policy evolution enters the policy promotion stage. as a new external stimulus, the improved policy continues to act on public cognition. more than that, the focus of perceived policy effectiveness begins to shift from crisis resolution to social normalization. under the control of the government, the grassroots implementation has been further improved, and the effectiveness of policies to solve current problems (i.e., crisis resolution effectiveness) has been effectively played. however, the effects of policies cannot limit to provide methods to solve the current problems, but also play a guiding role in the future development of society [ ] . public health emergencies make society change from normal state to emergency state, which has a great impact on public life and work [ ] . therefore, on the basis of effective resolution of the crisis, whether the policy can further promote the recovery of social normality has been widely concerned by the public. under the influence of public emotion caused by the cognition of policy utility, voice behavior emerges. in the stage of policy promotion, public promotive voice is policy unification. government policy-making under public health emergencies emphasizes the local government's ability of 'territorial management'. however, with the promotion of local policies across the country, the problem of compatibility between policies begins to emerge. the inconsistency of policies in different regions will bring many inconveniences to the public. therefore, in order to improve the effectiveness of policies, the public suggests that policies should be unified across the country. at this stage, with policy promotion, the audience range of the product is constantly expanding, the public's attention to the product utility is also increased. improvement suggestions to enhance the effectiveness are still the focus of voice. however, in addition to the utility of the product, the public also began to pay attention to the use experience of the product, pointing out the problems of the system in the use process. under the influence of public voice, the government and enterprises constantly improve the policies and products, and the policy evolution enters the optimization stage. at this time, with the public health emergency in the rehabilitation stage, the effectiveness of the policy has been played out to a greater extent; the public urgently need to return to normal life and work state, so the focus of perceived policy effectiveness is social normalization. public voice is still affected by the emotional response based on cognition, and the content of public voice has changed further. considering the adverse impact of public health emergencies, with the purpose of preventing the recurrence of the public health emergency, the public suggest that the policy should be normalized. policy normalization can predict the occurrence of public health emergencies in the early stage and minimize the loss. in addition, the public begin to pay attention to the coverage of the policy, pointing out that the omission of the population covered by the policy may have a negative impact on the fairness. with regards to the products of enterprises, the public voice focuses on the risks of long-term use of products. products are tools for enterprises to participate in cooperative governance and used to supply policy implementation. with the help of products, enterprises take part of the responsibilities originally belonging to the government, which will cause public concern. to sum up, public voice plays an important role in the evolution of policies. first, public opinion provides the widest source of information for policy feedback. public health emergencies require the government to formulate effective policies in the shortest time based on the least information and resources, and the effectiveness of the policies is uncertain [ ] . the public voice gives quick feedback to the policy, which provides the basis for the government to evaluate the effectiveness of the policy. second, the public voice expresses the public interest demands and promotes the policy to be more democratic and efficient [ ] . in order to gain more and more public support in the process of policy-making, public voice is an important consideration for the government in the process of formulating and implementing policies. finally, public voice behavior also plays an important role in product improvement and innovation. it can be seen from the analysis, that in the policy of government enterprise cooperation, due to the particularity of the product, the public's requirements are more stringent. voice for product improvement aims at making it more suitable to assist policy implementation, and it will provide an important reference for enterprise product innovation. this study reveals the driving mechanism of public voice behavior and enriches the literature on voice behavior. first, based on the results of qualitative research, this paper employs the cognitive appraisal theory of emotion to explain the process of formation of public voice behavior under public health emergencies, via the stimulus-cognition-emotion-behavior model. unlike voice within an organization, public voice on social media is a kind of self-motivated behavior free from the pressure of peers and organizational climate [ ] . what is more, as the purpose of public voice is to improve social status quo, the cognitive appraisal theory of emotion is eminently suitable for explaining the formation of public voice behavior. as an external stimulus, a policy will have an impact on the public's cognitive processes, and prompt them to evaluate whether the policy can resolve a current issue and play a guiding role in the future development of society. when the public perceives the policy to be highly effective, they will have positive emotions; otherwise, they will have negative emotions. take the health code policy as an example, if the public think that the policy can effectively contain the spread of the novel coronavirus and speed up the resumption of the normal activities, they will experience positive emotions, and vice versa. in accordance with the cognitive appraisal theory of emotion, emotional response will stimulate behavioral tendencies. the public's positive emotions will lead them to employ a promotive voice to expand the effectiveness and coverage of the policy, whereas the public has the tendency to use prohibitive voice to reduce the possible negative effects of a policy when they are not satisfied with its effectiveness. this result is consistent with previous studies that make a clear distinction between promotive voice and prohibitive voice, where the former is positive in tone and the later negative [ ] . in this study, members of the public feeling positive emotions will voice to promote a policy and establish uniform standards throughout the nation, whereas those experiencing negative emotions will identify deficiencies such as implementation at the grassroots level. second, this study clarifies the objects and types of public voice. compared with employee voice and customer voice, the coverage of public voice is more extensive. thus, for different problems, the objects of public voice are also different, which require separate analysis in each situation. under this circumstance, the objects of public voice include two main bodies involved in policy-making: governments and enterprises. for the health code policy, the objects of public voice are the government, alibaba, and tencent. with regard to voice type, there is some similarity with the other two kinds of voice-public voice can also be divided into promotive voice and prohibitive voice. finally, through qualitative research, this paper has attempted to reveal the role of public voice in policy evolution and product innovation, clarifying the promoting effect of public voice on societal improvement. the study emphasizes the importance of public voice via social media, suggesting that both government and enterprises ought to attach more significance to public voice when making decisions. taking china's health code policy under covid- as an example, this paper has constructed a dynamic mechanism for the effects of public voice on policy evolution. the study focused on the promotion of public voice for policy improvement and evolution in the late stages of policy-making. public opinion contains information about demands and aspirations which is very valuable for decision makers. to absorb more public opinions and take into account public aspirations or priorities before policy formulation, previous research has paid much attention to the impact of public opinions at the pre-policy-making stage [ , ] . no studies have examined the impact of public voice on policy after its implementation. the development of social media not only provides a wider source of information for the public, but also builds a more convenient platform for the public to voice their opinions at any stage of policy formulation or implementation, thus having effect on policy. this study shows that after a policy is implemented, public voice is still of great value for policy evolution. however, this study divides policy evolution into three stages: policy formation, policy promotion, and policy optimization. it introduces changes in public policy utility perception and public voice content at different stages, and constructs the dynamic mechanism of the effect of public advice on policy improvement based on the government's adoption of public advice to promote policy evolution and implementation. to some extent, this study provides support for cooperative governance research. cooperative governance has different connotations in different situations, and there are also some differences among participants. the formulation and evolution of policies under public health emergencies is an important practice of cooperative governance. faced with a public health emergency, the government, enterprises, and citizens should form an open overall system to jointly govern social public affairs. the government, enterprises, and individuals play their own roles, participate and cooperate with each other to effectively reduce the negative impacts of a crisis and maintain the stable development of society. in this process, governments, enterprises, and the public are in a more equal position, and multi-agent participation is truly realized. faced with covid- , yaowen wang, deputy director of shenzhen municipal government service data management bureau, said the epidemic situation was a great challenge to the government's governance ability and level. in addition, the fundamental problem was laid in whether the whole society could be quickly mobilized and organized to participate in the prevention and control in a short period of time. as an organ of power, the government is responsible for the formulation and implementation of policies. enterprises participate in the formulation of policies, and provide products and services with technical advantages to assist with policy implementation. as for the public, in addition to regulating their own behaviors under the guidance of policies, they also provide feedback and voice on policies and enterprises' products and services. take china's health code policy as an example, the government is responsible for the formulation and implementation of the policy. alibaba and tencent are committed to the development and updating of the health code system and participate in the formulation of the policy standards. the public need to move around in strict accordance with the policy guidelines and actively provide voice. under a public health emergency, public voice is an important way for public to participate in cooperative governance. it provides real-time feedback for policy, helping government and enterprises to make decisions as quickly as possible and set aside more time to fight against emergencies. further, public voice can facilitate the promotion of effective policy, improving prevention efficiency. as a universal way of participating in cooperative governance, public voice via social media deserves more attention in the future. although this research makes several contributions, there are still some limitations. first, we studied the influence of public voice only on policy evolution and specific product innovation. as public voice is social-oriented, it will affect almost all social affairs and phenomena. future research can explore the influence of public voice behavior in other respects. second, this study revealed the generative mechanism of public voice behavior from the perspective of emotional cognition. as a self-oriented behavior, public voice may be triggered by other internal processes. future research could explore the antecedents of public voice from different perspectives. third, this study was conducted under a public health emergency, covid- . as public emergencies take several forms, the results differ in different situations. future research might examine public voice in other contexts. fourth, although many countries and regions have formulated corresponding policies in the context of public health emergencies, results from the study of china's health code policy under covid- may not be fully applicable to other nations, and future research should be conducted in different cultural contexts. author contributions: y.y. conceived the idea of this study, y.s. collected and analyzed data and wrote this paper. all authors have read and agreed to the published version of the manuscript. speaking up when water is murky: an uncertainty-based model linking perceived organizational politics to employee voice leadership behavior and employee voice: is the door really open? acad leader personality traits and employee voice behavior: mediating roles of ethical leadership and work group psychological safety constructive voice behavior for social change on social networking sites: a reflection of moral 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arrangements in switzerland and germany cooperative forms of governance: problems of democratic accountability in complex environments hangzhou proposes more expansive health code system we read the technical standards for china's 'health code has launched for days, covering billion users the national health code standard, which tencent participated in developing, was officially released the national standard of personal health code was released, and alibaba participated in the formulation introduction: understanding public policy through its instruments-from the nature of instruments to the sociology of public policy instrumentation if it changes it must be a process: study of emotion and coping during three stages of a college examination emotion and adaptation how governmental policy is made dynamics of a stressful encounter: cognitive appraisal, coping, and encounter outcomes sacred land, mineral wealth, and biodiversity at coronation hill, northern australia: indigenous knowledge and sia. impact assess. proj democratisation versus engagement? social and economic impact assessment and community participation in the coal mining industry of the bowen basin public deliberation in an age of direct citizen participation servant leadership and follower voice: the roles of follower felt responsibility for constructive change and avoidance-approach motivation this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the authors declare no conflict of interest. key: cord- - ko n authors: cunningham, andrew a.; daszak, peter; wood, james l. n. title: one health, emerging infectious diseases and wildlife: two decades of progress? date: - - journal: philos trans r soc lond b biol sci doi: . /rstb. . sha: doc_id: cord_uid: ko n infectious diseases affect people, domestic animals and wildlife alike, with many pathogens being able to infect multiple species. fifty years ago, following the wide-scale manufacture and use of antibiotics and vaccines, it seemed that the battle against infections was being won for the human population. since then, however, and in addition to increasing antimicrobial resistance among bacterial pathogens, there has been an increase in the emergence of, mostly viral, zoonotic diseases from wildlife, sometimes causing fatal outbreaks of epidemic proportions. concurrently, infectious disease has been identified as an increasing threat to wildlife conservation. a synthesis published in showed common anthropogenic drivers of disease threats to biodiversity and human health, including encroachment and destruction of wildlife habitat and the human-assisted spread of pathogens. almost two decades later, the situation has not changed and, despite improved knowledge of the underlying causes, little has been done at the policy level to address these threats. for the sake of public health and wellbeing, human-kind needs to work better to conserve nature and preserve the ecosystem services, including disease regulation, that biodiversity provides while also understanding and mitigating activities which lead to disease emergence. we consider that holistic, one health approaches to the management and mitigation of the risks of emerging infectious diseases have the greatest chance of success. this article is part of the themed issue ‘one health for a changing world: zoonoses, ecosystems and human well-being’. by the s, the human burden of infectious diseases in the developed world was substantially diminished from historical levels, largely due to improved sanitation and the development of effective vaccines and antimicrobial drugs [ ] . the emergence of a series of novel diseases in the s and s (e.g. toxic shock syndrome, legionnaire's disease), culminating with the global spread of hiv/aids, however, led to infectious disease rising back up the health policy and political agendas [ ] . public concern about emerging infectious diseases (eids) has been heightened because of the perception that infectious diseases were previously under control, because of their often rapid spread (e.g. severe acute respiratory syndrome; sars), because they often have high case fatality rates (e.g. ebola virus disease) and because the development of drugs and vaccines to combat some of these (e.g. hiv/aids) has been slow and costly. by the s, authors had begun to review similarities among these diseases and identify patterns in their origins and emergence [ , ] . similarities included a skew to zoonotic pathogens originating in wildlife in tropical regions (e.g. ebola virus), and that emergence was associated with environmental or human behavioural change and human interaction with wildlife (e.g. hiv/aids) or with domestic animals which had interactions with wildlife (e.g. nipah virus) [ - ] . emergence was found to be exacerbated by increasing volumes and rates of human travel and globalized trade [ ] . by the end of the s, the study of eids was a staple of most schools of public health, a key focus of national health agencies, a book topic and the title of a scientific journal [ ] . novel diseases continued to emerge, often from unexpected reservoirs and via new pathways. for example, between and , three new zoonotic viruses (hendra, menangle and nipah viruses) emerged from pteropodid bats in australia and southeast asia [ ] . each of these was transmitted via livestock (horses or pigs), and each belonged to the paramyxoviridae. around this time, emerging diseases were identified in a series of well-reported die-offs in wildlife, including canine distemper in african lions (panthera leo) in the serengeti, chytridiomycosis in amphibians globally, pilchard herpesvirus disease in australasia and west nile virus in corvids and other birds in new york [ - ] . pathogens were also implicated for the first time in species extinctions, or near-extinctions, e.g. canine distemper in the black-footed ferret (mustela nigripes), chytridiomycosis in the sharpsnouted day frog (taudactylus acutirostris) and steinhausiosis in the polynesian tree snail, partula turgida [ - ] . novel diseases and their emergence in people and wildlife were reviewed, and commonalities in the underlying causes of emergence discussed, in a paper published at the end of the decade [ ] . here, we re-examine some of the key conclusions of that paper, review how the field has progressed years on and identify some of the remaining challenges to understanding and mitigating the impacts of disease emergence in and from wildlife. prior to , wildlife diseases were mostly studied to improve zoo animal survival and welfare, with little published on the diseases of free-living wildlife unless they affected heavily hunted species (e.g. deer in north america) or were considered a threat to livestock health (e.g. tuberculosis, rinderpest). while non-infectious diseases had been widely recognized as important drivers of species declines (e.g. ddt poisoning of raptors [ , ] ), only a small number of researchers investigated infectious disease as a factor in, often covert, wildlife population regulation [ , ] . the role of infectious diseases in mass mortality events or population declines was often considered controversial or secondary to other factors [ ] , and their role in species extinctions often disputed [ , ] . the first definitive identification of disease as a cause of species extinction was published in following the demise of the last population of the polynesian tree snail p. turgida due to a microsporidian infection [ ] . this added to evidence that infectious agents had caused the extinction in the wild of the black-footed ferret, the extinction of around one-third of hawaiian honeycreepers and the slime mouldinduced decline of eelgrass (zostera marina) beds in the usa, leading to extinction of the eelgrass limpet (lottia alveus) [ , - ] . during the s, wildlife mortality events caused by infectious diseases were reported in zoos, in wildlife translocation programmes and in other conservation programmes [ - ] . perhaps the most important of these was the discovery of amphibian chytridiomycosis, caused by the chytrid fungal pathogen batrachochytrium dendrobatidis, which was first recognized in the s and has since been implicated in the decline or extinction of over species of amphibian [ , , , ] . this disease continues to threaten amphibians globally and has been described as 'the worst infectious disease ever recorded among vertebrates in terms of the number of species impacted, and its propensity to drive them to extinction' [ ] . amphibian chytridiomycosis appears to have emerged contemporaneously in australia and central america, associated with large-scale die-offs and extinction events, although in retrospect it might have been causing amphibian mortalities and declines in north america prior to this [ ] . proving that a disease is a cause of population declines in wildlife requires longitudinal population and pathogen data, which are often very difficult to collect. thus, a series of papers disputing the role of chytridiomycosis in amphibian declines ensued, with most suggesting that this disease either emerged secondarily to other factors, or that it was not the cause of declines/extinctions [ - ] . long-term datasets have since been published which provide convincing evidence that amphibian chytridiomycosis alone can cause mass mortalities leading to population declines [ ] . policy measures to control amphibian chytridiomycosis, however, have been slow to be enacted, with the first international policy measure (listing of chytridiomycosis by the world organisation for animal health) occurring in [ ] and with the implementation of measures recognized to mitigate the spread of this disease still not being enacted by the international community [ ] . public and political reaction to the more-recent emergence of white nose syndrome (wns) in north american bats provides evidence that the conservation implications of wildlife eids are becoming more widely accepted. the causative agent of wns is the fungus pseudogymnoascus destructans which colonizes the skin of a range of temperate-zone bats, often causing death during hibernation [ ] . only year after the initial discovery of the disease in the usa in january , visitors to bat caves across the country were being advised to reduce visits and to implement biosecurity measures, and by , caves in over states were closed to the public. the disease has been the focus of a series of grants, formation of multi-disciplinary research partnerships and significant efforts to identify pathogenesis, transmission pathways and potential control measures [ , ] . although there is a growing recognition of the impact of pathogens on wildlife, the significance of infectious disease as a cause of historical extinctions is likely underestimated due to a previous relative lack of infectious disease focus and diagnostic capability [ ] . collaboration among ecologists, conservation biologists and veterinary pathologists is relatively recent and increased pathological and epidemiological involvement in studies of the causes of wildlife declines are critically needed to identify and understand disease threats to wildlife and how to mitigate them. in addition to identifying an apparently growing trend of disease threats to wildlife, daszak et al. [ ] highlighted wildlife as the source of a series of high-impact, recently emerging pathogens affecting people. these authors reiterated the widely proposed hypothesis that most emerging pathogens rstb.royalsocietypublishing.org phil. trans. r. soc. b : originate in wildlife and spillover into human hosts due to a range of ecological, demographic and socio-economic changes [ , , ] . prior to , these wildlife-origin pathogens were known to include ebola and marburg virus, hiv- and hiv- , sin nombre virus, nipah, hendra and menangle virus, west nile virus, borrelia burgdorferi and others. since then, other human diseases have emerged from wildlife, including middle east respiratory syndrome (mers) and different subtypes of avian influenza, and further advances have been made in our understanding of patterns of zoonotic disease emergence. a series of papers analysed a database of all known human eids and confirmed that the majority are of animal origin, with viruses being a particularly important group [ - ] . further analysis of an updated version of this database identified that eids had increased in frequency (even accounting for increased numbers of researchers), with the proportion of those emerging from wildlife hosts increasing substantially over the last four decades of the twentieth century [ ] . the emergence of bat-origin viral eids of people during the s was highlighted by daszak et al. [ ] . since then, it has been shown that bats are reservoir hosts of a striking number of zoonotic viruses, including high-profile pathogens with high case fatality rates, such as nipah and hendra paramyxoviruses, filoviruses, sars-like coronaviruses and possibly also mers coronavirus [ , ] . this led some authors to propose that bats harbour a disproportionate number of emerging zoonoses compared with other mammalian groups [ - ] : a hypothesis that has been supported by two separate analyses of mammal virus datasets [ , ] . understanding why bats host so many zoonotic pathogens that cause lethal diseases in humans and how spillover from bats to humans occurs is important in order to control these, and possibly as-yet-undiscovered, diseases [ , - ] . there are likely to be multiple causes of novel disease emergence, but the human-mediated transport of pathogens (often in infected hosts) or vectors across geographical or ecological boundaries, a process termed 'pathogen pollution', has been identified as a major driver of this in wildlife [ ] and also in plants [ ] . the anthropogenic spread of pathogens has been responsible for the emergence of a series of high-profile wildlife eids, including the two known agents of amphibian chytridiomycosis, b. dendrobatidis and b. salamandrivorans [ , ] . subsequent research indicates that this is only part of the story, as it appears that the global pandemic lineage of b. dendrobatidis arose from a single hybrid origin via an ancestral meiosis, possibly via the anthropogenic mixing of allopatric lineages [ , ] . there is a substantial volume of research that shows how, once evolved, this virulent lineage has been introduced globally via the international trade in amphibians and via the human-assisted introduction of invasive species [ , - ] . in recent years, a body of literature has developed the concept of the ecosystem service of disease regulation. while still controversial, and probably not universal [ ] , this proposes that natural biodiversity limits the exposure and impact of many pathogens, including those that are zoonotic, through a dilution or buffering effect, thus limiting opportunities for pathogen spillover from wildlife to people [ ] . when biodiversity is depleted (usually by human activities), this ecosystem service is impaired and zoonotic pathogens are more likely to emerge, as has been shown for hantavirus [ ] and for b. burgdorferi, the causative agent of lyme disease [ , ] . also, alteration of species complements (again, usually due to anthropogenic impacts), rather than loss of biodiversity per se, can alter infection dynamics and lead to increased zoonotic disease risk [ ] . our understanding of the interactions between ecosystem change, disease regulation and human well-being, however, is in its infancy. almost years since the threats to conservation and human health that wildlife eids represent was first highlighted, there has been little effort to put in place policies to reduce risk. detecting and preventing the importation of infected hosts is widely used to prevent importation of many domestic animal diseases of economic or public health importance. some countries even enact this principle for the movement of people, whereby they conduct (often cursory) surveillance for infected persons arriving at their international borders, particularly during human pandemics [ , ] . the world health organisation provides guidance and training on this through its international health regulations (http:// www.who.int/ihr/en/). rules and regulations for international trade, including of animals and their products, are created and enforced by the world trade organisation (wto), which has the remit of ensuring 'that trade flows as smoothly, predictably and freely as possible' (www.wto. org). the wto agreement on sanitary and phytosanitary measures was enacted on january with the aim of protecting human, animal and plant life from disease-causing agents. while countries have discretion in what should be included, they are guided by the world organisation for animal health (oie) list of diseases of international importance. although the oie has a remit of protecting biodiversity, only two pathogens are listed for this purpose: b. dendrobatidis and ranavirus [ ] . most countries, therefore, use import controls to only protect against domestic animal diseases of obvious public health or economic importance, such as rabies and foot and mouth disease; diseases restricted to wildlife are not included even when oie-listed. in addition, trade agreements often prohibit barriers to international animal movements for the purposes of infectious disease control. for example, countries within the european union have little ability to prevent the spread of pathogens via within-eu trade unless as part of a specific eu disease control programme. even where technically legal under wto rules, there appears to be reluctance by countries to unilaterally impose restrictions on non-listed diseases in case they create an economic disadvantage or are subsequently found to be in breach of international trade regulations. it is possible that the international spread of amphibian chytridiomycosis would have been reduced if such measures had been implemented for this disease [ ] . perhaps learning from this, in january , the usa banned the importation of salamanders following the emergence of b. salamandrivorans in order to protect native wildlife from this novel pathogen [ ] . such protective action was enacted relatively rapidly following the discovery of b. salamandrivorans as a novel lethal fungus infecting and killing captive and wild salamanders in europe [ , , ] challenges remain to understanding the wildlife origins of zoonotic eids. it is often difficult, time-consuming, logistically challenging and very expensive to identify the origins of newly emerged pathogens of humans. for example, viruses similar to hiv/aids were discovered in non-human primates in the early s, but identification of the true progenitor viruses in chimpanzees took almost a decade of additional research [ ] . similarly, the origins of ebola and marburg viruses have been investigated for over years. to date, however, despite indications that bats are the natural reservoir hosts of these viruses, clear evidence has only been found for marburg virus infection in bats in limited locations [ - ] . identifying putative reservoir host(s) is just the beginning. in order to identify actions to prevent or mitigate future zoonotic spillover, both an understanding of the ecology of the pathogen in its natural host(s) and of human -host interactions are required [ ] . for example, substantial efforts have been conducted to understand immunological, behavioural and ecological characteristics of bats as part of a strategy to control zoonotic spillover from bats [ ] [ ] [ ] . long-term, multi-disciplinary studies that systematically investigate the ecology of zoonotic pathogens in their wildlife hosts along with the risk characteristics for spillover are critical to better predict and prevent future pandemics [ ] . such a study, which included years of field data collection on fruit tree distribution, pig farm management, viral dynamics and satellite telemetry of fruit bats, analysis of climate trends, experimental infection of bats under biosafety level- conditions and mathematical modelling of virus infection dynamics, identified the intensification of the pig industry as the driver of the zoonotic emergence of nipah virus in malaysia [ ] . these results informed government policies to separate pigs from bats via the removal of fruit trees from pig farms and the relocation of farms away from forested areas [ ] , since when no further nipah virus disease outbreaks have occurred in malaysia. eid events have been the focus of intense research over the past two decades, even though the numbers of people diagnosed with them are often relatively small. this disproportionate focus on eids probably relates to the dislike of human society for uncertainty, or put more simply, fear of the unknown. this may lead to perverse scenarios in which fear of disease can have a greater impact than the direct impact of the outbreak itself. for example, during a recent ebola virus epidemic in west africa, more people are estimated to have died from malaria due to their avoidance of healthcare facilities, where they feared they might catch ebola, than the thousands that died from the virus itself [ ] . indeed, when one considers the overall impact of zoonotic diseases on the human population, the largest (diagnosed) burden is associated with well known and fully recognized (in the industrial north), but neglected, diseases such as brucellosis, rickettsioses and rift valley fever [ ] . this predictable burden falls heavily on the global poor-poverty being the major risk factor for most zoonoses, which in turn causes some communities to suffer disproportionately from the burden of zoonotic disease [ ] . the neglect of such diseases includes diagnostic neglect (and confusion with other conditions such as malaria [ ] ) and historic and current research neglect; all of which feeds into therapeutic neglect. the delivery of the united nations sustainable development goals, which should result in much reduced poverty and improved health, will in themselves reduce the substantial burden of zoonotic disease. one health is the term used when approaches to tackling disease ( particularly zoonoses) consider all components that might lead to, or increase, the threat of disease. these include environmental and ecological/wildlife components as well as domestic animal and human factors. the last encompasses behavioural as well as medical issues, including cultural, political and other socio-economic drivers that might result in disease occurrence or spread. the review by daszak et al. [ ] was perhaps the first 'one health' review of emerging diseases, in that it brought together veterinary, ecological, conservation and human medical perspectives on disease emergence. the field of one health has expanded substantially since , diversifying to produce new journals, such as one health, ecohealth and the lancet planetary health, the one health platform, the international association of ecology and health, the planetary health alliance and a series of one health institutions in the usa, europe, australia and increasingly also in developing countries. the success of this multi-disciplinary approach has been driven largely by the synergistic impact of combining detailed and logistically challenging field sciences (e.g. ecology, field biology) with analytical approaches (e.g. epidemiological modelling, pathogen phylogenetic analysis) and laboratory science (e.g. serology, pathogen diagnostics, immunology). challenges remain, however. importantly, while the conservation, ecological and veterinary professions are increasingly engaged with one health, substantial elements of the medical profession are not aware of, or involved in, this approach. despite their neglect, a number of zoonotic diseases are eminently controllable or manageable by one health approaches, including infectious causes of abortion in livestock, which frequently result in febrile human disease, and human rabies transmitted via dog bites. control or prevention is best achieved through integrated public health, veterinary medicine, animal management and ecological approaches. one particular challenge for this is in the case of some zoonotic infections that do not cause clinical signs in their animal hosts, one of the most common examples of which is campylobacter spp. infection of poultry, which globally is the most frequent cause of food poisoning in humans [ ] . is it, then, the responsibility of farmers and vets to ensure that people do not become infected, or of public health practitioners or the general public through improved kitchen hygiene and behaviours? here, this would involve reduced infection of poultry (the role of farmers and veterinarians), reduced contamination of meat (the responsibility of veterinary public health workers) and preventive measures in the kitchen (hygiene and proper cooking), which are the domain of public health workers and the public [ ] . one health approaches are required at the policy and governance levels, too. responsibility for preventing and treating zoonotic disease, in both a developing and rstb.royalsocietypublishing.org phil. trans. r. soc. b : developed world setting, for example, often falls in between government ministries of health and agriculture (and for wildlife, ministries of environment and forestry) and this can structurally prevent the simplest of solutions from being implemented. an important example is rabies in humans transmitted through dog bites which kills around people annually [ ] and causes fear in many more in rabies endemic regions. the disease is easily preventable (and arguably open to eradication) through repeated annual or biannual mass vaccination of dogs [ ] . in many countries with a high burden of rabies in dogs, considerable sums are spent by the public and ministries of health annually on post-exposure prophylaxis (pep-often given after dog bites whether or not the animal was known to be rabid). the expense of this repeated treatment usually dictates that far more is spent on treatment than would be required to vaccinate all dogs in the same region. however, in many countries, the dog is regarded as a pest and not an agricultural animal for which ministries of agriculture have responsibility. in others, the dog does fall under the agricultural ministry, but these ministries are typically far less well resourced compared with ministries of health, thus rabies, which does not relate to food animals, is not prioritized. the obvious solution is for a synergized one health approach with the ministries of health supporting prophylactic vaccination programmes for dogs delivered by their typically far less well-resourced ministries of agriculture. this, however, rarely seems to happen and continued expenditure on bite management and pep continues. one health programmes addressing rabies have been extremely successful when appropriately resourced [ , ] ; however, they often fail to influence national government policy and are rarely adopted long term [ ] . in addition to the high costs of dealing with endemic zoonoses, such as rabies, emerging and re-emerging zoonoses can have substantial economic impacts. the cost implications of zoonotic eids were highlighted by daszak et al. [ ] as a rationale for policy measures, but methods for calculating the economic consequences of disease emergence have not advanced in the interim. despite clearly high financial impacts associated with some eids, few detailed economic analyses of their impact have been undertaken. estimates of the cost of the sars outbreak, for example, range from $ to $ billion, while the true costs of most eids have never been estimated [ ] . pike et al. [ ] approached the problem of disease emergence in the same way as the climate change phenomenon. they used the increasing frequency of emerging disease events reported by jones et al. [ ] to analyse two strategies to deal with the rising costs of eids over time: adaptation, whereby we adopt a business-as-usual approach and continue to cause increased eid events, then target control programmes after emergence; and mitigation, whereby we deal with the underlying drivers (e.g. wildlife trade, deforestation) and reduce the frequency of eid events. pike et al. [ ] show that mitigation strategies are more cost effective in the long term, with a -fold return on investment, and that these need to be enacted on a global scale within the current generation or the cost of eids becomes unaffordable. what would these global strategies entail? we highlight three approaches. first, a series of emerging diseases have been linked to the wildlife trade, or consumption of wildlife (e.g. sars, ebola). the health implications of the trade in wildlife have not been widely used to implement controls, or advocate for reduction in consumption, and may be a more effective message than its conservation impacts. this needs to be done judiciously, however, as disease spillover is a rare event and both bushmeat hunters and consumers will be wary of public health messages that do not fit with their experiences [ , ] . second, a revision of an earlier analysis of global drivers of disease emergence [ ] shows that land-use change correlates strongly with the emergence of zoonoses from wildlife (p daszak , unpublished observation). in malaysia, analyses of the economic cost of diseases that emerge due to land conversion for palm oil production (e.g. malaria, leptospirosis) are currently being used to advise industry where to reduce long-term impact. identifying land-use changes that lead to disease emergence informs policies for mitigation strategies. this could be done, for example, via the incorporation of wildlife and zoonotic disease threats in environmental impact studies, an approach for the prevention of disease emergence suggested by daszak et al. [ ] . third, targeted global surveillance programmes to identify novel pathogens of zoonotic potential before they emerge may increase our capacity to reduce their risk of emergence. for example, a series of laboratories now specialize in identifying novel viruses from wildlife hosts, e.g. bats [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the usaid emerging pandemic threats programme specifically targets emerging disease hotspots to identify novel viruses from bats, rodents and primates, to characterize high-risk behaviours in people and to identify potential mitigation strategies [ ] . while these programmes have already identified over new viruses from viral families with known zoonoses in the last few years, challenges remain in how to identify those with the highest (or any) risk of zoonotic emergence. this indicates that a change in approach is required, building on rapidly expanding databases of pathogen sequences, phenotypic characteristics and host-pathogen interactions. for example, the rapid incorporation of novel viral sequences into diagnostic tests may lead to more rapid identification of related, previously unknown, pathogens that emerge in outbreaks. using this approach, combined with a one health perspective that targets the underlying drivers of emergence, could result in the identification of pathogens that already are spilling over from wildlife hosts sporadically at low levels, enabling measures to be taken to reduce pandemic risk. since the synthesis paper by daszak et al. [ ] highlighted emerging disease threats of, and from, wildlife and the main drivers underlying these, further advances have been made in our understanding of the origin, size and potential scope of these threats. endemic zoonoses, however, continue to be relatively neglected, often with a lack of local and international realization of the extent to which they impact human health and well-being. this is partly due to issues surrounding local capacity and knowledge and partly because, unlike eids, they are not seen as a threat to people in the developed world. both eids and endemic zoonoses, however, can be tackled using a one health approach, including the rstb.royalsocietypublishing.org phil. trans. r. soc. b : identification and mitigation of human activities that lead to disease emergence and spread. one health approaches to dealing with disease threats from and to wildlife are still relatively young and untried, but all evidence points to them being most successful and 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endemic canine rabies the changing landscape of rabies epidemiology and control achieving population-level immunity to rabies in free-roaming dogs in africa and asia effective vaccination against rabies in puppies in rabies endemic regions rabies control and elimination: a test case for one health economic optimization of a global strategy to reduce the pandemic threat ebola and bushmeat: myth and reality henipavirus rna in african bats hantavirus in bat bats host major mammalian paramyxoviruses receptor usage and cell entry of bat coronavirus hku provide insight into bat-to-human transmission of mers coronavirus isolation and characterization of a bat sars-like coronavirus that uses the ace receptor a sars-like cluster of circulating bat coronaviruses shows potential for human emergence authors' contributions. a.a.c. conceived the idea for the article. all key: cord- - hahh authors: fan, shihe; blair, corinne; brown, angela; gabos, stephan; honish, lance; hughes, trina; jaipaul, joy; johnson, marcia; lo, eric; lubchenko, anna; mashinter, laura; meurer, david p.; nardelli, vanessa; predy, gerry; shewchuk, liz; sosin, daniel; wicentowich, bryan; talbot, james title: a multi-function public health surveillance system and the lessons learned in its development: the alberta real time syndromic surveillance net date: - - journal: canadian journal of public health doi: . /bf sha: doc_id: cord_uid: hahh objective: we describe a centralized automated multi-function detection and reporting system for public health surveillance–the alberta real time syndromic surveillance net (artssn). this improves upon traditional paper-based systems which are often fragmented, limited by incomplete data collection and inadequate analytical capacity, and incapable of providing timely information for public health action. methods: artssn concurrently analyzes multiple electronic data sources in real time to describe results in tables, charts and maps. detected anomalies are immediately disseminated via alerts to decision-makers for action. results: artssn provides richly integrated information on a variety of health conditions for early detection of and prompt action on abnormal events such as clusters, outbreaks and trends. examples of such health conditions include chronic and communicable disease, injury and environmentmediated adverse incidents. discussion: key advantages of artssn over traditional paper-based methods are its timeliness, comprehensiveness and automation. public health surveillance of communicable disease, injury, environmental hazard exposure and chronic disease now occurs in a single system in real time year round. examples are given to demonstrate the public health value of this system, particularly during pandemic (h n ) . zone. the alberta real time syndromic surveillance net (artssn) was developed with three goals: ) improve upon traditional paperbased, fragmented public health surveillance using a centralized automated system; ) enhance routine public health surveillance through effective use of existing provincial electronic health record data for earlier detection of cases, clusters, outbreaks and trends of communicable disease, injury, and environmental hazard exposure; and ) track the effectiveness of public health interventions. this paper describes artssn and the lessons learned in its development as a real-world application of syndromic surveillance. artssn is a modular system consisting of multiple real time health level (hl ) data feeds from operational systems and selective data from the provincial electronic health record repository alberta netcare, a supporting data repository, a provincial enterprise master patient index, a terminology translation service and a user interface. in its first phase of development, artssn obtained a privacy impact assessment approval for four streams of electronic data for residents of the edmonton zone: ) telephone calls to health link alberta; ) emergency visits; ) laboratory tests; and ) school absenteeism (table ) . health link alberta (hl) provides a / / province-wide service for health advice and information. registered nurses use a decision support tool of protocols to assess calls; each protocol consists of detailed algorithms for triaging symptom-based chief complaints (cc) and providing advice and information for managing symptoms and directing patients to appropriate health care. at the time of writing, hl had protocols; artssn used . six hospitals and three urgent care centres provide emergency visits data through an emergency department (ed) information system (edis) or an electronic triage information system (etriage). online data forms syndromic, varying with specific forms as required diagnostic * average time from a nurse answering a call at health link alberta to the time when the call record is seen by an artssn user is . (sd = . ) minutes ( tests on different days). note that the nurse may spend a variable amount of time answering the call and artssn receives the record only after the call is closed. the data transmission time is therefore substantially less than indicated. † average time from a visit being triaged at an emergency department to the time when the record is seen by an artssn user is . (sd = . ) minutes ( tests on different days). ‡ not tested. the proprietary data repository is a scalable oracle™ database. data elements (see table ) are first extracted from the feed databases, transformed, cleansed, checked for completeness and reorganized. personal identifiers are replaced with meaningless pseudo-keys. the repository also receives data manually entered into electronic forms through an online survey module of the user interface. population data for the edmonton zone, as derived from the provincial health insurance registry and broken down by gender, age group and geographic area, are contained in the repository for rate calculation. the terminology translation service uses look-up tables for syntactic and semantic translation. it unifies terms within and between data sources and translates ccs (ed data) and protocols (hl data) to a standard set of syndromes and "health concerns", and translates school absenteeism to a standard set of reasons for absence. each health concern consists of similar syndromes (physiologically or anatomically) and is named accordingly, e.g., all cardiovascular syndromes are grouped under the cardiovascular heading. the user interface was developed by voxiva (washington, dc). it is intranet-based and secured behind a firewall for authorized uses only, and has submodules for ) data analysis and visualization, ) automated notification, and ) system administration. the data analysis and visualization submodule can present results in tables, charts or maps by person, place, time, cc, discharge disposition, laboratory test and result, or disease agent either by count or by rate. these products can then be saved for future reference, exported for reporting, or placed on online dashboards for real-time surveillance. line listings of data can also be exported for off-line analyses or scientific research. the automated notification submodule continuously compares incoming data to pre-set thresholds for the diseases or syndromes under surveillance by person, place and time according to algorithms configured within a series of notification templates. the algorithms are based either on rate or count, depending on the diseases or syndromes. if a threshold is surpassed, prompt notification is automatically dispatched to designated personnel via means specified in their notification subscription. for instance, alerts of school absenteeism due to illness ≥ % were sent to the artssn epidemiologist on november , during wave of ph n . this automated notification improves traditional surveillance markedly since a very large number of conditions can now be effectively surveyed by many combinations of person, place and time. this degree of examination would be extremely laborious and expensive using traditional methods. the system administration module controls, among other functions, access to the system, data sources, and functions of the system. users are first grouped into a role matrix according to their responsibility and institutional affiliation. a profile of privileges is built for each role; users sharing a common role are further controlled by manipulating their privileges, such as being limited to only a single data source or reduced system functions. a novel feature of artssn is the patient re-identification mechanism. under the public health act in alberta, notifiable diseases must be reported to the local public health department for investigation. consequently, a drill-down function was built in the system for authorized users such as moh, communicable disease control nurses or environmental health officers, which allows them to reidentify individuals using the enterprise master patient index via the pseudo-key. artssn is multi-functional and has many potential uses in public health surveillance. figure shows its use in pandemic surveillance, using ed visitation data during ph n to inform the timely opening of a mass influenza assessment centre and then evaluating its impact on relieving pressure in the eds. figure demonstrates use for injury prevention. in january and february of , the local public health department used media assistance to advise the public of treacherous road conditions and precautions required when driving or going outdoors. injury prevention is one of the five key areas recommended for improving the health of canadian children. from to , approximately one third of ed visits by young people were injury-related (table ) . artssn followed four design principles: automated, real-time, routinely useful and locally useful. automation minimizes interruptions to real-time surveillance even during the most resource-challenging conditions like ph n (figure ). each ed visit or hl call about influenza-like illness (ili) or laboratoryconfirmed ph n case is automatically acquired by the data repository and updated on online dashboards for timely understanding of the pandemic progressing in the community. the information is then relayed to emergency operation centres to inform their pandemic responses. real-time information also enables ed managers to promptly re-allocate patient care and infection prevention and control resources based on ed patient flow, punctually intervene in screening ili patients and significantly improve ili data quality. the ph n experience demonstrates that artssn is truly useful to both the data user and provider. real-time surveillance reduces recall bias and improves interpretation of statistical associations since immediate temporal, spatial and population connections are possible as events are unfolding ( figure ). real-time surveillance in artssn gives public health practitioners a new tool to survey injury, environmental hazard exposure, chronic and communicable disease comprehensively for improved and targeted health protection and promotion. being routinely useful enables artssn to gain wide user support; users (groups), including data providers, moh, communicable disease and environmental health epidemiologists in the edmonton zone, as well as all moh in the province, now have real-time information for decision-making. although biological, , nuclear or radioactive terrorist attacks are all potential threats to public health, such attacks are rare compared to the frequency of infectious disease outbreaks, unintentional injuries or severe weather-related events. a system solely dedicated to small probability events may be unsustainable over time at the local level. being locally useful means that artssn carefully balances the needs of both the data provider and data user. strategies included rapid feedback about the quality, meaning and limitation of the data; help in defining the requirements and functions of artssn; and joint efforts in the development of surveillance products. evaluation was done in parallel with system development by independent evaluators for simplicity, acceptability, utility and other aspects following established frameworks for evaluation of public health surveillance systems. , issues or concerns raised were assessed and resolved promptly. consequently, the user interface is more intuitive; new users can become proficient with two to three hours of instruction. artssn was developed through rapid successions of data collection, analysis, interpretation and dissemination in iterative "plan, do, check, and act" cycles, avoiding past practice of sequentially optimizing each individual step before moving to the next. for example, hl data were first extracted into the repository; line listings, graphs, tables and maps were then developed using other software before the user interface was ready. feedback about these prototypes was incorporated into the next development cycle. these rapid, iterative cycles uncovered deficiencies earlier, gained user acceptance faster, and obtained support more broadly, allowing artssn to be implemented more relationship between daily emergency department visits for injuries (a) and daily maximum/minimum temperatures (b) from january to february , during the specified data period, unusual warming periods (daily maximum temperatures above zero) intermingled with rain and light-snow events. each warming episode melted the packed snow surface in daytime and refroze it at night, which caused icy road conditions and increased emergency visits for injuries. one such warming period (between / and / ) is highlighted in the figure. daily injury visits a b rain snow swiftly (< years from launching to operation) than some legacy surveillance systems. the data repository is critical to artssn. it facilitates data-flow from the source to the user interface without interfering with the stability and functionality of the operational databases. data pseudonymization simplifies privacy impact assessment approval for the system and ethics approval for research use of data. this central repository approach differs from other distributed systems where the data reside with their originator. [ ] [ ] [ ] a key advantage to artssn is that the database is a centralized model within a single health organization, making the repository development and maintenance easier. this centralization significantly improves public health surveillance through the multi-functions of artssn by avoiding fragmentation that has plagued traditional surveillance systems. the pandemic (h n ) showed that automated data acquisition in artssn could be disrupted if the source capacity was exceeded (see figure ). for instance, the repository was unable to receive call data when health link alberta was forced to streamline call recording using paper instead of its time-intensive electronic system. moreover, unlike other systems, , , artssn lacks statistical modeling capability. thresholds for the syndromes and diseases under surveillance require individual programming based on historic data. difficulties remain in simultaneously deciphering aberration signals from multiple data streams and in determining the syntactic and semantic relationship in free-texted medical records in some new databases as artssn is expanding from a regional to a provincial system. these issues are being addressed by working with data providers and by collaborating with university researchers on natural language processing and statistical analysis. a retrospective study on clinical features of and treatment methods for severe cases of sars severe acute respiratory syndrome epidemic in asia identification of severe acute respiratory syndrome in canada emergence of a novel swine-origin influenza a (h n ) virus in humans transcript of statement by margaret chan, director-general of the world health organization. geneva: who secondary aerosolization of viable bacillus anthracis spores in a contaminated us senate office forensic application of microbiological culture analysis to identify mail intentionally contaminated with bacillus anthracis spores syndromic surveillance: the case for skillful investment implementing syndromic surveillance: a practical guide informed by the early experience syndromic surveillance systems a massive outbreak in milwaukee of cryptosporidium infection transmitted through the public water supply a fatal waterborne disease epidemic in walkerton, ontario: comparison with other waterborne outbreaks in the developed world syndromic surveillance of gastrointestinal illness using pharmacy over-the-counter sales aegis: a robust and scalable real-time public health surveillance system grafstein e for the canadian emergency department information system (cedis) working group. a consensus-based process to define standard national data elements for a canadian emergency department information system emergency triage: comparing a novel computer triage program with standard triage are we ready for pandemic influenza? researching for the top: a report by the advisor on healthy children and youth. ottawa, on: health canada operation of a real-time syndromic surveillance system during pandemic (h n ) . ccdr (accepted) signals come and go: syndromic surveillance and styles of biosecurity public health agency of canada. framework and tools for evaluating health surveillance systems framework for evaluating public health surveillance systems for early detection of outbreaks information system architectures for syndromic surveillance distributed data processing for public health surveillance propagation of program control: a tool for distributed disease surveillance a systems overview of the electronic surveillance system for the early notification of community-based epidemics (essence ii) technical description of rods: a real-time public health surveillance system objectif : nous décrivons l'alberta real time syndromic surveillance net (artssn), un système multifonction, centralisé et automatisé de détection et de production de rapports de surveillance de la santé publique. il s'agit d'une amélioration par rapport aux anciens systèmes sur papier, souvent fragmentaires, limités par la collecte de données incomplètes, par des capacités d'analyse insuffisantes et par l'impossibilité de fournir de l'information en temps utile pour les interventions de santé publique.méthode : l'artssn analyse simultanément plusieurs sources de données électroniques en temps réel et en présente les résultats sous forme de tableaux, de diagrammes et de cartes. les anomalies décelées sont immédiatement communiquées aux décideurs pour qu'ils puissent agir. key: cord- - mjimzdt authors: raj, anita; johns, nicole e.; barker, kathryn m.; silverman, jay g. title: time from covid- shutdown, gender-based violence exposure, and mental health outcomes among a state representative sample of california residents date: - - journal: eclinicalmedicine doi: . /j.eclinm. . sha: doc_id: cord_uid: mjimzdt background: there is increasing evidence of the negative impact of the covid- pandemic and resultant shutdowns on mental health. this issue may be of particular concern to those affected by intimate partner violence (ipv) and sexual violence. methods: we conducted a cross-sectional analysis using data from a california state-representative online survey conducted in the two weeks following the state stay-at-home order, enacted march , (unweighted n = ). we conducted a series of multivariate multinomial logistic regressions to assess the associations between a) time since stay-at-home order and b) partner and sexual violence exposure ever with our outcomes of interest: depression and/or anxiety symptoms in the past two weeks. covariates included demographics and social support. findings: nearly one in five ( • %) respondents reported moderate or severe mental health symptoms in the past two weeks; • % had a history of ipv and • % had a history of sexual violence. in models adjusting for gender, partner and sexual violence history, and other demographics, time was significantly associated with greater mental health symptom severity, as were ipv and sexual violence. when we additionally adjusted for current social support, effects of time were lost and effects related to violence were slightly attenuated. interpretation: time under shutdown is associated with higher odds of depression and anxiety symptoms, and may be worse for those with a history of ipv. however, those with greater social support appear to have better capacity to withstand the mental health impacts of the pandemic. social support programs, inclusive of those available virtually, may offer an important opportunity to help address increased mental health concerns we are seeing under the pandemic. funding: blue shield foundation of california grant rp- – . bill and melinda gates foundation opp . global evidence documents the mental health impact of the covid- pandemic and resultant government-enforced social distancing efforts, particularly the issues of depression and anxiety [ ] . this issue may be of particular concern to those affected by intimate partner violence (ipv) and sexual violence, given the impact of these on mental health [ ] . there are also indications of potential increase in such violence under covid- related shutdowns [ ] and as seen previously in other crisis contexts, such as earthquakes [ ] . isolation and feelings of helplessness may exacerbate these concerns in the face of the pandemic, as may financial stressors resulting from government shutdowns, particularly with ongoing time. research has not examined associations of time under the covid- pandemic and history of violence exposure with mental health outcomes. this study examines the association between time and self-reported depression and anxiety symptoms among a representative sample of california adults recruited over a two-week period in march , at the start of the statewide government shutdown. our primary hypothesis of this study is that time À since shutdown and under the pandemic À will be associated with increased odds of reporting greater severity in depression and/or anxiety symptoms in the past two weeks, at a population level. secondarily, we also consider whether history of ipv and sexual violence exposure, and financial status in the context of the shutdown, also independently affect severity of depression and/or anxiety symptoms, beyond that explained by time under the pandemic. finally, we explore whether current social support attenuates or mitigates observed associations between time and depression and/or anxiety symptoms, as well as between our violence and income indicators and our outcome of interest. we analyzed data from a representative sample of california residents aged and older (n = ), surveyed on experiences of violence and mental health via an online survey implemented march th to march th, as part of the california study on violence experiences across the lifespan (cal-vex ) [ ] . the survey initiation date coincided with the first day of the governorinstituted statewide shutdown in response to the covid- pandemic, and was around the time of statewide recognition of the presence of coronavirus in california and, in some places, identified community spread. the cal-vex survey was developed by our team with inputs from an advisory board of experts on violence, and it was administered by norc at the university of chicago using their online probability panel (amerispeak) and supplemented by additional nonprobability opt-in panels (dynata and lucid) to reach the desired sample size of individuals [ ] . statistical calibration was performed by norc to combine these samples and create a survey-weighted final sample that is representative of the california adult population with regards to several key socio-demographics, including gender, age, race/ethnicity, income, education, employment status and region of the state (additional detail on data calibration and weighting methodology have been published elsewhere [ , ] ). the recruitment rate for this study was %, and the response rate was %. these are standard for online panel surveys, which hover around À % [ ] . our sample was generated from a general population sample of california adults age and older selected from norc's amerispeak panel. amerispeak Ò is a probability-based panel designed to be representative of the us household population and is funded and operated by norc at the university of chicago. randomly selected us households are sampled using area probability and address-based sampling, with a known, non-zero probability of selection from the norc national sample frame. these sampled households are then contacted by us mail, telephone, and field interviewers (face to face). the panel provides sample coverage of approximately % of the u.s. household population. those excluded from the sample include people with p.o. box only addresses, some addresses not listed in the usps delivery sequence file, and some newly constructed dwellings. while most amerispeak households participate in surveys by web, non-internet households can participate in amerispeak surveys by telephone. households without conventional internet access but having web access via smartphones are allowed to participate in ameri-speak surveys by web. the amerispeak panel sample was additionally supplemented with respondents from the dynata and lucid nonprobability online opt-in panels. statistical calibration was conducted by norc to combine these probability and non-probability samples to be representative of the state in terms of a pre-determined set of demographic and geographic characteristics. to ensure the representativeness of the sample, our team compared the resultant sample to census and other government data. the study sample is representative of the adult california population with respect to gender, race/ethnicity, education level, employment status, income, age, and disability status. our sample may slightly over-represent lesbian, gay, bisexual and other sexual minority individuals, and may slightly underrepresent foreign-born individuals and non-citizen residents. findings should be considered in this light. the norc team contacted the participants to invite them into the online survey. the online survey took approximately minutes to complete, and panelists were offered the cash equivalent of usd$ for completing this survey. survey participation was voluntary and allowed respondents to decline questions (outside of demographics) or stop the survey at any time. participants in the survey panel agreed to privacy policies provided by norc, and our research team only had access to completely anonymized data. given the sensitivity of the survey items, a survey prompt was provided with the following text, "if you are experiencing distress or discomfort, see this website for services in the state https://victims.ca.gov/resources.aspx." all research procedures were approved by both norc/university of chicago and the university of california san diego institutional review board (project # xx). evidence before this study evidence from china suggests increased mental health concerns as a consequence of the covid- pandemic, but no research has examined whether time under the pandemic or a shutdown further elevate this risk. additionally, there is indication of a rise in gender-based violence under the pandemic and resultant shutdowns, but this has not been analyzed in terms of how such violence or even histories of such violence may affect mental health. this study examines both time under shutdown/pandemic and exposure to partner and sexual violence ever as risk factors for severity in depression and/or anxiety symptoms in the past two weeks, with a state representative sample in california. it additionally examines whether current social support attenuates any observed effects of these exposure variables, to guide potential interventions at scale. findings demonstrate higher than normal depression and/or anxiety symptoms in our sample under shutdown/pandemic conditions, and a significant association between time in days under shutdown/pandemic and severity of depression and/or anxiety symptoms. they also demonstrate elevated risk for poor mental health outcomes among those with a history of intimate partner violence (ipv), a concern disproportionately affecting women. however, findings also reveal that adjusting for social support eliminates findings related to time under shutdown and slightly attenuates findings related to ipv, suggesting the potential value of social support interventions implemented at scale to address mental health concerns under the pandemic and particularly for vulnerable populations. as covid- impacts continue, it will be imperative for governments, health systems, and other support organizations to ensure mental health resource availability, both broadly and especially for these vulnerable populations. social support systems and networks, including those delivered virtually, may be useful as we continue to contend with the pandemic and resultant social isolation. our primary independent variable of interest was time, measured by day of survey. by chance, our survey was initiated on march th, coinciding with the california state-wide stay at home order (in effect march , ) , and ended on march th, allowing unique insight into potential effect of the pandemic on mental health. the resultant 'time' variable is a continuous variable of days. our dependent variable was severity of depression and/or anxiety, assessed via four items on the number of days the participant experienced depression and anxiety symptoms in the past two weeks, taken from the patient health questionnaire- (phq- ) [ ] . anxiety was captured by two items, "feeling nervous, anxious, or on edge" and "not being able to stop or control worrying". depression was captured by two items, "little interest or pleasure in doing things" and "feeling down, depressed, or hopeless". response options were, "not at all" = , "several days" = , "more than half of the days" = , "nearly every day" = . the severity of symptom score was created as stipulated by the phq- tool, by adding together the scores of each of the four items and categorizing scores as normal ( À ), mild ( À ), moderate ( À ), and severe ( À ). the cronbach alpha for this measure was . covariates in our model included demographics (self-defined gender, monthly income categorized into wealth quintiles, employment, race/ethnicity, age, sexual orientation [gay, lesbian, bisexual, or straight], and disability), history of ipv and sexual violence, and social support. we assessed ipv via a series of items on whether the respondent had ever experienced physical violence (including being physically hurt or having a knife or gun pulled or used on them) or sexual abuse (including verbal sexual harassment, cyber sexual harassment, physically aggressive sexual harassment, quid pro quo sexual harassment, or forced sex) from a spouse or romantic partner. we created this measure for this survey based on prior research and expert input [ ] . cronbach alpha was . we assessed sexual violence by a single item on whether the respondent had every experienced "forced sex -this can include someone forcing you to do a sexual act without your permission or one that you don't want to do (including while you are under the influence of alcohol or drugs)." this is a standard measure used in national surveys on sexual violence [ , ] . we assessed current social support via a single item from the centers for disease control and prevention's behavioral risk surveillance system [ ] which asked, "how often do you get the social and emotional support you need?" a four point response item was used: always, usually, rarely, or sometimes. low reported social support from this item has previously been shown to be associated with poorer mental health outcomes [ ] . we present frequency data on all key variables for the total sample and by gender, and we used chi-square analyses and t-tests to assess differences by gender on our variables of focus. we conducted a series of multinomial logistic regressions to assess associations between time and mental health symptom severity (normal, mild, moderate, severe): model adjusted only for time and gender. model additionally adjusted for ipv and sexual violence histories. model additionally adjusted for wealth quintile. model additionally adjusted for employment, race, age, sexual orientation, and disability. model additionally adjusted for social support, to see if this affected other observed associations. all analyses accounted for survey design and weighting to produce state-representative findings, and were conducted using stata . funders had no role in the decision to develop these analyses or in the development of this manuscript for publication. the total sample of study participants was n = , but our final analytic sample consisted of individuals, women and men. individuals missing information on the primary outcome (n = ) were excluded, as were those identifying as transgender or other gender (n = ) due to small cell sizes in our gender-stratified analyses. half of participants ( %) were in the normal range on our mental health outcome; % reported mild symptoms of depression and/or anxiety; % reported moderate symptoms; and % reported severe symptoms, in the past two weeks. (see table .) we found that % and % of the sample reported a history of ipv and sexual violence ever, respectively. women were significantly more likely than men to recent report depression and/or anxiety symptoms ( % vs %, p = ), ipv ( % vs %, p< ) and sexual violence ever ( % vs %, p< ). our initial models, those adjusting for gender (model ), gender and violence (model ), and gender, violence, and income (model ), all demonstrate significant positive association between time and depression and anxiety symptoms. (see table .) for the initial models inclusive of our violence variables (model and model ), we also found ipv and sexual violence associated with mental health symptoms. adjusted odds ratios [aors] are presented. ipv ever was associated with greater odds of mild and moderate relative to normal mental health symptoms (e.g., model ); sexual violence findings were no longer significant. in terms of covariates, black race/ethnicity or other race/ethnicity (not black, white, asian, or hispanic), relative to white, and older age ( + years), relative to age À years, were negatively associated with reports of mental health symptoms. minority sexual orientation relative to straight and disability relative to no disability were positively associated with having mental health symptoms in the past two weeks. in our final adjusted model, which included current social support as well as demographics as covariates (model ), the association between time since shutdown and recent mental health symptoms was lost. however, ipv ever remained associated with greater odds of recent mild and moderate relative to normal mental health symptoms in this model (model aors: mild [ À ]; moderate [ À ]), though findings were slightly attenuated. in terms of covariates, findings from the prior model were retained. black and other (not black, white, asian, or hispanic) relative to white individuals and older ( + years) relative to young adult ( À years) individuals were less likely to report mental health symptoms. sexual minorities relative to straight individuals and those living with a disability compared to those without a disability were more likely to report having mental health symptoms in the past two weeks. findings related to income in our analyses were more complex across models. in our model inclusive of time, gender, violence, and income (model ), those in the higher and highest wealth quintiles, relative to those in the lowest, had lower odds of recent mental health symptoms (model higher wealth quintile aor: severe [ À ]; highest wealth quintile aor: severe [ À ]). in the model adjusting for all demographics (model ), significant findings were lost. however, in the model adjusting for all demographics and current social support (model ), findings as compared with model were altered. more specifically, higher and highest quintile findings were no longer significant, and elevated risk was seen for middle income individuals in terms of severe symptoms (model middle wealth quintile aor: severe [ À ]). findings from this study demonstrate that approximately one in five people in this representative sample of california adults recruited during the first two weeks of pandemic shutdown report moderate to severe symptoms of depression and/or anxiety in the past two weeks, a higher prevalence than that seen in prior research with both general and patient populations under non-covid- conditions [ , , ] . these findings correspond with prior research suggesting increased odds of depression and anxiety due to covid- and the resultant shutdown [ ] , and extend this work by highlighting that the odds of poor mental health, as indicated by symptoms, increase daily under shutdown conditions. they further indicate that those with a history of ipv or sexual violence, a concern disproportionately affecting women, are particularly vulnerable, findings seen in prior research as well [ ] . those with a history of ipv in particular appear to be at greater risk. our ipv assessment does not allow for indication of recency, only history, and further research is needed to determine the relative roles of current versus history of ipv risk in contributing to poorer mental health outcomes. indications that ipv may be increasing under shutdown conditions may be at play [ ] , but fears of isolation-related vulnerabilities for those with a history of such violence may also be a concern. importantly, however, findings from this study also show the potential value of active social support in mitigating risk for these symptoms, given loss of findings for time and somewhat attenuated findings in terms of ipv exposure after accounting for current social support. socially marginalized groups such as sexual minorities and those living with a disability also reported greater odds of severity of mental health symptoms in the past two weeks, which again has been seen in prior research [ , ] . disability in particular demonstrated a very strong association with severe depression and/or anxiety symptoms, even after adjusting for current social support. the pandemic and shutdown may be taking a greater toll on this population, due to their potential greater vulnerability to complications if coronavirus infection occurs and/or due to greater social and health vulnerabilities they may face generally. overall, these findings suggest that already vulnerable populations may be greater risk for pandemicrelatedmentalhealthconcerns,butthatsocialsupportmayusefulformanagementoftheseissues. an additional finding from this study is the lower odds in recent severity of depression and/or anxiety symptoms for higher and highest income quintile groups related to the lowest income group, in models with time, violence exposure, and income. such findings would suggest greater protection for higher income groups, possibly because of greater buffer against both viral exposure and financial stressors related to the pandemic and resultant shutdown. however, upon adjusting for demographics and social support, we see a notable change in the association between income and mental health outcomes, such that lower to middle-income groups have higher odds of poor mental health than the lowest income group. this unexpected finding may be a consequence of perceptions of greater vulnerability to the economic ramifications of the shutdown without safety net access (i.e., income-related welfare programs) or the greater representation of this population among essential workers, who may face greater risk for coronavirus exposure at work. such findings highlight the importance of supports against financial stressors at this time, and for working populations. while findings offer important insights, they should be considered in the light of certain study limitations. the effects of the pandemic are continuing, and we cannot know that our findings remain an accurate reflection of current circumstances; however, given the robust research evidence regarding mental health effects of the pandemic as described earlier, we believe findings likely remain relevant. data are self-report and therefore subject to recall and social desirability biases. findings are based on cross-sectional analyses and causality cannot be presumed from these findings. longitudinal data, and data collected more regularly to account for seasonal and other variations that affect reports of depression and anxiety symptoms, would be important for future research to examine these issues. this would also allow for greater understanding of longer term effects of the pandemic and shutdown on these symptoms. additionally, the survey was not designed to examine effects of the pandemic or time under shutdown, so we are limited in our assessments of both of these, the latter only allowing for a two week timeframe. we also cannot disaggregate time from shutdown and time under pandemic from these data. our outcome covers a time preceding the stay at home order, but social distancing, and consequently social isolation, preceded the statewide shutdown order for many participants, as some counties had already received local shutdown orders [ ] and some may have been reducing social contact prior to any order [ ] . to consider this point, we analyzed severity of mental health symptoms by day of survey data collection, and compared this with state level data using similar indicators; findings confirm that, even by day one of data collection, we see higher than expected depression and/ or anxiety symptoms. prior statewide data from california indicate that approximately % reported moderate to severe anxiety symptoms and À % reported moderate to severe depressive symptoms over a longer time period, past days [ ] , whereas we found that % of our participants on day one of data collection reported moderate to severe depression and/or anxiety symptoms. importantly, findings can only be understood in terms of symptoms and not mental health diagnosis. we are also limited in our reliance on an online probability panel that facilitates engagement of a nationally representative sample, but participation rates were low. however, as noted above, these rates are typical of online studies [ , ] . nonetheless, random sampling is the recommended approach to reduce potential biases inevitable in on-line rapid surveys that may reduce representative inclusion of those affected by mental health issues [ ] . hence, the current findings are likely not fully representative of those affected by depressive and anxiety-related symptoms in the current context of the pandemic, but this is likely yielding underrepresentation of the scope and scale of this concern. while this is a representative sample, via use of weighting procedures, it is also a convenient sample in the sense that it is an online survey, leaving it vulnerable to biases. norc has taken steps to reduce some of the biases from typical online surveys as much as possible, including area probability and addressbased recruitment and inclusion of non-internet and non-cell phone households in the survey panel sample. they also use a non-response follow-up campaign via the diverse contact information provided by respondents. ultimately, these findings add to the developing literature examining the health impacts of covid- , and suggest that covid- and resultant shutdowns may be contributing to worsening mental health at a population level, with increasing risk over time. moreover, individuals with a history of intimate partner or sexual violence, women, and other socially marginalized populations are disproportionately experiencing these mental health burdens, possibly because isolation and negative effects of isolation are worse for these groups. at the same time, the findings indicating the attenuation of time effects on mental health after accounting for current social support suggest the value of social support interventions to ameliorate mental health impacts. as covid- impacts continue, it will be imperative for governments, health systems, and other support organizations to ensure mental health resource availability. this will be especially important for socially vulnerable populations. social support systems and networks, including those delivered virtually, may be particularly useful as we continue to contend with the pandemic and resultant social isolation. data from this study is freely available minus potentially identifiable demographic variables. if an individual is interested in receiving a copy of the dataset, they can send a request via email to geh@ucsd. edu. please include in the subject line "request for cal-vex survey data." please include in the text of the email the purpose of the request and planned use of the data, including proposed research questions of interest. this project was funded through grants from the blue shield foundation of california (grant # rp- À ) and the bill and melinda gates foundation opp this paper was developed independent of the study sponsors. they had no input into study design, data collection/analysis/interpretation, write-up of findings, or the decision to submit the paper for publication. the authors have no conflicts of interest to declare. the outbreak of covid- coronavirus and its impact on global mental health lifetime prevalence of gender-based violence in women and the relationship with mental disorders and psychosocial function covid- : reducing the risk of infection might increase the risk of intimate partner violence women's mental health and intimate partner violence following natural disaster: a scoping review study on violence experiences across the lifespan, cal-vex study : methods and preliminary findings estimation methods for nonprobability samples with a companion probability sample combining probability and non-probability samples using small area estimation computing response metrics for online panels an ultra-brief screening scale for anxiety and depression: the phq- measuring #metoo: a national study on sexual harassment and assault facts behind the #metoo movement: a national study on sexual harassment and assault public health surveillance and informatics program office social and emotional support as a protective factor against current depression among individuals with adverse childhood experiences a -item measure of depression and anxiety: validation and standardization of the patient health questionnaire- (phq- ) in the general population state-level comparisons of mental health issues from the national survey on drug use and health (nsduh) and the behavioral risk factor surveillance system (brfss) relationship between physical disability and depression by gender: a panel regression model mental health of sexual minorities. a systematic review the bay area's battle against coronavirus smartphone data reveal which americans are social distancing (and not) the adequacy of response rates to online and paper surveys: what can be done says who? the significance of sampling in mental health surveys during covid- we would also like to acknowledge the research team and advisory board for the cal-vex study for their instrumental contributions to this work, and norc at the university of chicago for their survey data collection and collaboration with us. in particular, we would like to recognize lilibeth ramirez for her contributions to this study, with regard to supporting its administrative management and organizing, as well as her support of survey development and review of data for the study as a whole. supplementary material associated with this article can be found in the online version at doi: . /j.eclinm. . . key: cord- -f yt a authors: parmet, wendy e.; robbins, anthony title: public health literacy for lawyers date: - - journal: j law med ethics doi: . /j. - x. .tb .x sha: doc_id: cord_uid: f yt a nan lic health advocacy institute, with support from the centers for disease control and prevention, assembled experts froni legal education, public health practice and education, the judiciary, foundations, and the publishing industry to consider what changes would have to occur in legal education so that law graduates would be "literate" in public health and how those changes could come about.b in this article we build upon the intense discussions of the conference participants. we make the case for introducing public health into the core law school curriculum and suggest the content that would be needed to achieve public health literacy among law students. we also argue that public health's focus on populations, aided by the tools of epidemiology, provides a valuable prism for understanding the relationship of individuals and groups and the ways that laws can and ought to affect them. we conclude by urging the development of a body of scholarship and analysis that brings the insights of public health to bear on legal questions. law schools might introduce public health to their students in several ways. most comprehensively, law students can enroll in a j.d./m.p.h. program, and receive the training given public health graduate students for a masters degree in public health. while such programs are increasingly common, they are obviously intended for students already committed to careers at the intersection of law and public health. thus jd/mph programs do not reach the vast majority of law students. a larger number of law students can i x exposed to public health in upper level electives that focus on public health law or a particular topic closely related to public health, such as aids law or food and clnig lawn undoubtedly, the content and the extent of exposure to public health principles and methocls will vary widely depending on the particular topic of the class. through these courses, law schools can provide :i limited number of students with in-depth exposure to one or more public health problems and the legal tools and doctrines most relevant to those topics. law faculty and public health professionals at a workshop' dedicated to developing a curriculum on bioterrorisin concluded, for example, that a hasic understanding of public health powers woulcl be an essential part of any course on bioterrorism. most law students, however, will never get ;i mph or take a public health oriented elective in law school. if they are to be introduced to public health in the course of their legal training, it will have to be within existing, core law school courses, the courses that are generrilly required of first year students or taken almost universally by upper level students. at the public health literacy conference, the lawyers present identified several such courses-tom, constitutional law, environmental law, and administrative law-as prime candickites for the inclusion of public health. attendees also recognized that the integration of public health into such courses would be d#icult to achieve given legal education's traditional reluctance to embrace significant reforms. nevertheless, attentlees agreed that it was important to pursue the effort. what public health knowledge or set of skills should all law students acquire? if these could be identified, educators from law and public health could explore how to incorporate then in core law courses. successful integration of public health into standard law school courses would introduce students to: law's public health context w public health powers w public health inethocls public health's population perspective two criteria must be met, according to the public health literacy conference attendees, if law professors are to adopt public health components in core courses. first, the integmtion must not be too hard to accomplish. materials must be available, and support, in tenns of tine, money, wining, and academic respect, must be forthconling.'o second, faculty must believe that the inclusion of such nuterials will not only be good for public health, but that it will also enhance their students' legal skills and pertiaps legal analysis itself. the reminder of this article seeks to adclress these concerns by exploring more fully the four components of a public health education for lawyers identified above-md examines how to empower law students to be literate in public health, law schools must help them to recognize public health issues and be familiar with the lessons from the law's prior encounters with public health. for over a hundred years, legal scholars have stressed the importance of introducing lawyers to the social, economic, and political context in which the law operates. they have also counseled the value of interclisciplinary analysis. in he path of the luw, for example, justice oliver holmes scolded the legal profession for its belief that law exists apart from the world in which it operates. he argued that lawyers should be trained to understand "the social advantage on which the rule they lay clown must be justified.,."" following in holmes' footsteps in the early twentieth centuly, the legal realists asserted the inipomnce of the facts, out there in the world, to legal analysis. in their "revolt against fonnalism," legal realists suessecl the value of the social sciences and empirical analysis to legal decision making. in subsequent decades, legal scholars from a wide spectrum of perspectives and disciplines stressed the need for interdisciplinary work and social context in order to achieve a rich understanding of the law. scholars and jurists from the conservative "law and economics" school, for example, have focused on understanding the economic context in which the law operates. first, they proclaimed the value of applying economic reasoning to legal decision ~naking.'~ then they recast the analytic tool, useful to explain societal decisions, as an assertion that economic valuation is largely sufficient to comprehend human inotives. from a very different side of the political spectrum, femini~t,'~ critical race, and disability scholars have asserted the importance of teaching law students ahout the g e n d e d , racial, and disability context of legal issues. each group advocates for the inclusion of its issues and disciplines-milyses that shed light on a spectnini of legal issues. repeatedly, we are reminded in rather different ways that law students cannot fully appreciate the meaning or impact of the law unless they understand how it affects different people and reflects critical social phenomena." similarly, we recommend the inclusion of public health analysis and the public health context in which the law operates. public health teaches us that the health or well being of indivicluals is influenced by forces that operate at the population level, beyond an individual's own conm .' risks to health, and the health problems they create, have had a profound influence not only on the lives of individuals, but also shape societies and the structure of our law." to understand not only public health, but the law, students should grasp the public health context in which key legal docuines have developed. students will then recogmze public health issues when they arise, placing them in a fuller and familiar context of similar issues they have studied. they will appreciate more fully the reasons for and implications of the particular doctrines they are mastering. examples from three different areas of the law may serve to demonstrate what we mean by public health context. the first example comes from fourteenth amendment law. virtually every law student studies the infamous case of lochneru. new york, in which the supreme court struck down a state law setting maximum hours for bakeshop workers. o many scholars have viewed lochneras one of the pivotal cases in constitutional law. indeed, many legal theorists regularly cite it when they deride judicial decisions. ' to cry "lochner" is to question the legitimacy of a constitutional decision. lochner, like most important supreme court cases, was about many things and many themes can be dissected the rise of the labor movement;t the supreme court majority's antipathy to progressive labor legi~lation;~~ and the struggle between courts and legislature^.^^ legal scholars, however, seldom discuss the public health context, although the statute at issue was presented by the state of new york as a public health measure and bakeshop workers did experience numerous diseases, including a high prevalence of infectious tubercul~sis.~~ in fact, justice peckhani, writing for the majority of the supreme court, recognized that the statute would have been constitutional if it were indeed, truly, a public health measure. thus, one of the key questions implicit in lochnerwas the meaning of public health and whether worker protection issues could be seen as a valid concern for public health. examined in this manner, lochner provides an interesting insight into the contested nature of public health and the government's role in protecting it. the provision of this context to lochnermay not change a student's ultimate opinion about whether the case was correctly decided, but it may shed new light on the decision. this expanded analysis of lochner would prepare students to understand the ways in which struggles over the scope of public health have helped to weave the fabric of our law. a second example also offers itself from constitutional law, this time relating to the commerce clause doctrine. as numerous commentators have noted, in l~$ezu. united stares, the supreme court r e v d its analysis of congressional power under the commerce clause, making it more difficult for congress to enact regulatory legislation.a this constriction of congressional power appeared to derive, in part, from the court's concern for safeguarding the traditional police powers of the states. underlying that concern was the assumption that police powers constitute a relatively static set of powers, aimed at protecting the public's health and safety, and that these powers have traditionally been the exclusive province of the states. an understanding of public health history, however, makes problematic the notion that public health powers have been or can be the exclusive domain of the statesm real world public health context intrudes. an analysis of public health problems in the modern global environment-from sars ' to the question of youth violence at issue in lopez--raises doubt about the ability of states acting alone to protect the public from such hazards. this analysis does not demonstrate that the supreme court was wrong in lopez-. certainly the coun confronted interpretative and federalism problems beyond the scope of public health, but a discussion of the way in which health problems cross state and even national boarders suggests that lopez' impact may be other than what the court thought. at least, if the court believed that it was protecting the police power and thereby the ability of states to safeguard the health and welfare of their populations, it may well have announced a constitutional rule that will result in exactly the opposite outcome, less protection for the health of a pop~lation?~ this may not prove to be so. but only by providmg students with the public health context behind the case can they huy assess the court's reasoning, speculate on the case's impact, and understand how constitutional doctrines may affect the lives of populations. a final example offered here-although many others can be given--comes from the famous tort case of stubbs v. city of rochester?" the case concerned an outbreak of typhoid fever in rochester, new york. the city offered two different water supplies, one for drinking and one for firefighting. the plaintiffs argued that sewage, known to be in the firefighting water system, contaminated the drinking water supply, causing the plaintiff to conmct typhoid fever. the issue before the court was whether the plaintiff had sufficiently proven that the defendant's negligence caused the typhoid. interestingly, sfubbsconstitutes an early example of a court finding epidemiological evidence sufficient to satisfy the plaintiff's burden of causation. thus the case provides an obvious opportunity to introduce students to basic concepts of epidemiology and to observe how methods for studying disease in populations have changed over the years. this would be useful to students, indeed essential, because tort litigation about product liability and toxic exposures has made epidemiology and public health science central to much civil litigation today, as we discuss later in this ankle.$ but the context of the case goes beyond an analysis of evidentiary issues. the development of clean, municipal drinking supplies is undoubtedly one of the great public health victories of all time. students reading the case should understand that cities did not always supply clean water for drinking and that prior to the introduction of clean water, concenmtion of populations in cities led to extremely high rates of death (especially among children) from diseases such as typhoid fever and cholera.b dr. john snow's study that linked cholem rates in london neighborhoods to the source of people's drinking water persuaded him to remove the handle from the contanlinated broad street pump, and incidentally helped give rise to the modern science of epidemiology.'g before the science of bacteriology learned to identify pathogenic microorganisms in the late th century, municipal authorities, acting on the lessons learned from epidemiology, had achieved a dramatic decrease in deaths from water-borne diseases by protecting drinking water supplies from human wastesa thus .seen in context, sttibbs is not simply about how we can infer individual causation based upon population data, a subject that future ton lawyers would be well advised to master."' stubbs is also a tale from public health's long struggle to use the forces of science and society to protect populations from infectious disease. whether or not the defenclant caused mr. stubbs' typhoid, there can be no doubt that the health of the public benefits from the provision of safe drinking water. but that insight will not be recognized by students who do not know (as many of our students likely do not), that only years ago, deaths from water-borne diseases were common in this country and that it took concerted public efforts to prevent preniatiire death. a second goal is for students to appreciate key legal doctrines that relate to public health, particularly the array of powers government uses to protect the population's health and the restraints the law places upon those powers." all law students cannot be expected to study public health law as preparation for becoming public health lawyers. nevertheless, they should understand the basic contours of how the government, acting through law, organizes to protect and promote the public health and the tensions and challenges created by the exercise of those powers. governments have always taken an interest in the health of their population. from the beginning, concerns about how to protect the population and prevent disease and injury have helped define the role of g~vernment.~) in the united states, activities by the states to promote public health came to form the core of what is known as the "police power." to be literate in public health, and indeed, to ix effective lawyers, law students should be acquainted with the idea of the police power, the limitations applied or suggested to restrain it, and ways that states exercise it. an introduction to the police power will provide students two critical legal strengths: an appreciation of the legal tools available to help carry out public health actions and.a deeper understanding of the law's role in promoting the health of the population. by delving into the police power, students will see first that government activities to promote and protect the population's health have historic roots. they are not an unusual contemporary phenomenon. second, such activities create difficult challenges for our legal system. public health colleagues withwt legal training, although they must use the police power, often lack this depth of understanding. a basic introduction to public health powers would also expose students to the complex role that the federal government plays in matters of public health. it is commonplace to assert that public health lies in the province of the states:s a carefill reading of history, however, demonstrates a critical and expanding federal role in the protection of public health, reflecting threats that exceed the capacity of states. (sonie threats exceed the capacity of national governments as well, such as biotemrism and global epide~nics.)~~ what tools are available for the federal government to ;issure protection of the public heal& the spending power and the commerce clause are most obvious. what doctrinal limitations constrain efforts to protect the health of the public? teaching these issues in their public health context, as we noted above, will enrich the students' understanding of the doctrines and facilitate the students' ability to use the law creatively. the stucly of public health powers can also provide an opportunity to explore the ways that law can be used to advance public goals. law schools usually emphasize private law and individual rights!' our public law courses-~~~s t i t~i t i o~l law, adnlinistrative law, and criminal law-ften highlight the legal rights of individuals and the lhnits of government action. far less discussion time is devoted to the use of the law as a positive instrument, to how governments can act, and the rationales for their action.@ to many lawyers, those questions appear to be outside of the law itself, within the domain of policy or politics. public health law in the core law school curriculum can provide a context for students to understand the broad range and durability of the powers different levels of government wield to protect the public. (such topics already appear in the syllabi of nlany courses in health and environmental law.) in other words, by looking at public health powers, students can become better able to appreciate and use the law positively to advance the public good. no discussion of public health powers would be complete without a consideration of the role that law plays in limiting those powers.@ a broad array of legal doarines, from the substantive due process doctrine developed under the th amendment of the constitution,so to doarines relating to judicial review of administrative agencies, evolved appreciably in the context of public health likewise, some of the earliest equal protection cases challenged actions taken by public health authorities who exercised their powers in a disainlinatory manner?* even today problems may arise when public health agencies use their authority in an unduly coercive or dwnnuna tory manner. lawyers have avenues available to restrain those actions. these topics can engage law students and help them appreciate that law is both a vital engine for public health, and also a critical mediating forre. . . . puellc health mixhod% law students can learn the basic scientific methods that public health employs and in doing so develop a broader acquaintance with quantitative and empirical techniques that are critical to the contemporary practice of law. the public health, conference noted that "public health draws on all the scientific knowledge that informs our understanding of how humans interact with their environments and manifest disease and injuries."s epidemiology, which studies the incidence, prevalence, distribution, and etiology of disease, is the core discipline of public health. epidemiologists rely upon a variety of experimental and observational studies, statistical and analytic methods. lawyers cannot be expected to become epidemiologists. to understand the public health issues, however, they should have a basic grasp of the quantitative and scientific methods on which epidemiology rests. at minimum, lawyers should understand the types of studies that epidemiologists rely upon,% possess a familiarity with the concepts of rates, incidence, and prevalence; be aware of the distinctions between association and causation; and recognize that there are many ways that epidemiologists infer causation from a s s~c i a t i o n .~~ lawyers might also receive a basic introduction to scientific reasoning,% the ways in which scientific consensus is developed,s and the distinctions between legal and scientific notions of "causation" and "truth."% (ironically, most scientists themselves simply do science, remaining unfamiliar with studies of science and scientific methods.") the suggestion that lawyers should be better informed about statistics and science is neither new nor exclusive to proponents for public health literacy. critics of the legal system's use, misuse, or abuse of science and scientists have long lambasted lawyers for their ignorance about what science is and how it works. @' a supreme court decision, dauben v. merrell dow pbumacmticak, lnc., and its progeny have made the debate central to tort litigation in the united states. z in daubert, the supreme court reconsidered the standards for admission of expert evidence. rejecting the earlier fty@ nile as incompatible with the federal rules of evidence, the court instead required federal judges to act as gatekeepers and determine whether the proffered evidence was "reliable," which the court claimed, required a determination of whether the evidence was based on a scientifically valid methodology.& in daubertitself, two justices questioned the wisdom of asking federal trial judges to take on the role of deciding what is good science and what is not, describing the task as akin to asking them to become "amateur ~cientists."~~ since daubert, however, in federal coum and many state coum, that is just what has happened.& because expert witnesses may offer opinions about causation that qijantwative and sceniwic reas ni"ln are thought to be useful to the finder of factjury or j u d g e a trial judge is now required to act as a "gatekeeper" and decide which expert testimony to admit. the daubert process-pretrial hearings on the admissibility of expert testimony-now donlinates product liability and toxic tort cases ' recently, the data quality act has extended a daubert-like process into federal agencies, providing an opportunity to challenge the science used in setting agency policy and in regulatory decision making. this means that every lawyer working with or in government agencies will need to understand science and quantitative reasoning as never before. all these procedures hinge on how lawyers understand and portray science, an important reason why an introduction of public health and scientific decision making is necessary in the core cumculum law school. lawyers employing the daubertprocess have spawned a vimal industry designed to inform judges and lawyers about the "abc's" of epidemiology, the scientific method, and statistics.@ these legal pundits on science have expanded on the court's suggestions in daubert, creating a check-list approach to assessing whether scientific testimony is relevant and reliable, confusing-often deliberately-the legal concept of causation with how scientists reach conclusions about little or none of this lawyers' rendition of science has been subjected to scholarly scrutiny by scientists, and legal practitioners and judges, largely uneducated about science and quantitative methods, have wandered far from scientific practice." the need for a better understanding of science among lawyers is now plainly evident. justice breyer, in his influential critique of the regulatory process and administrative law, has called for a more rigorous understanding of quantitative analysis, including cost-benefit analysis, in determining regulatory standards." the national academy of sciences has a committee of scientists and lawyers reviewing these issues. in light of daubert, lawyers must be better informed about how scientists assess causality, how they value evidence, and the application of epidenuology, toxicology, animal and clinical studies. thus, there is an urgent need to develop cumculum within law schools that teaches law students to understand quantitative science. and what better way than around public health issues, that are already deeply embedded in the law? it would meet the broader goal of ensuring that lawyers are competent consumers of epidemiological and statistical analyses and that lawyers can work collaboratively and intelligently with public health professionals, medical expew, regulators, and the plethora of other professionals who rely upon quantitative and empirical tools. lawyers should be able to think critically about populations and what it means to focus on them, as opposed to individuals. this approach to legal problems contrasts with the law's usual focus on individuals. drawing on the traditions of anglo-american liberalism, our jurisprudence posits individuals as mini-sovereigns, each replete with her or his own endogenous set of preferences and from this premise, the goal of law becomes regulation of the interaction of those mini-sovereigns; to protect their rights and property; and, for those who subscribe to utilitarian or neo-classical economic theories, to maximize their aggregate utility or wealth. law schools, with their typical emphasis on competition ancl non-collaborative work, reinforce the individualism evident in the doctrines this foundational individualism manifests itself in and deeply influences many fields of law. a few bwad-brushed examples may demonstrate the point. the field of health law itself, as john v. jacobi observed, concerns itself with "bilateral disputes over health finance, medical injury, and patient's rights...'" what is missing, he argues, are the "tools or the perspective" to address issues that affect populations. american constitutional law, too, is famously devoted to analysis and consideration of the rights and interests of individuakn thus the question of whether a woman can have an abortion is framed as a conflict between a woman's right to privacy versus the rights of the individual fetus. o the law of race discrimination, which was once understood as recognizing and responding to group harms:' focuses significantly on the needs and interests of individuals, rather than groups!* although the supreme court's recent decision to uphold race-conscious decision making by universities signals some recognition of the importance of group perspectives,b it remains me that state policies that disparately disadvantage suspect classes are not held to violate the constitution even if' the disadvantage to the group is clear and obviously foreseeable.& only when the state, anthropomorphized as if it were also an individual, intentionally aims at disadvantaging one or more people on the basis of their membership in a suspect class, is the constitution found to be offended.us even tort law, the field of common law most focused on population-based concerns, remains heavily influenced by individualism. as scholars have noted, traditional tort law, prior to the so-called ws "torts revolution," assumed that "individualism outranks concerns for others."& these tenets remain ensconced in the field, for example, in the noduty rule that many states continue to affirm!' perhaps the single most influential critique of traditional tort law emerges from scholars and judges who believe that the primary goal of tort law should be the maximization of economic efficiency.w while this position postulates the the dominating individualism of american law has come under sustained critique in recent decades from: fenunist scholars who postulate the importance of relationships;w critical race scholars who point out the need to understand the position of identity groups;" ancl communitarians who stress the primacy of nevertheless, these critics, remain just that: critics of the prevailing regime. their influence is occasionally evident in case law, but they have largely failed to alter the status quo. perhaps even more impoitantly, as david ortiz has noted, in many subtle but fundamental ways these critics share many of the individualistic premises of the jurisprudence they critique ~-ofien reifying groups or communities, treating them as if they were, in essence, individuals. what the critics,of individualism in the law seldom offer is a serious or sustained examination of groups (other than identity groups), which includes an analysis of them and their interests and their relationships to the individuals who fonn them. this, of course, is precisely what public health and its scientific foundations do. as jacobi writes, "[plublic health is a discipline dedicated to the scientific examination of the conditions affecting the health of populations." public health's prinlary sciences-epidemioiogy and biostatistics-focus on populations as populationsb and apply empirical, statistical, and analytical methods to understand how to define them, determine what affects them, and what distinguishes them from other populations, and how they relate to the individuals who comprise them. by comparing populations, epidemiologists have garnered ,insights useful to legal analysis. geoffrey rose explains that how populations are selected affects what can be learned.* for example, if we try to understand the causes of coronary artery disease by comparing people in a particular population who have heart attacks with those who don't, we may identlfy a risk factor, such as exercise, the presence of which differs between the groups. however, unless the population as a whole is compared with other populations, we may easily miss causes of the disease to which everyone in the population was exposed. only by many comparisons of many populations with different rates of disease, can be begin to idenufy all of the factors contributing to disease? ' rose's insights raises several points relevant for legal analysis.* first, he demonstrates how a focus on individuals-usually the symptomatic p a t i e n w a n at times obscure our understanding of what is happening to the larger group. thus the health damage done to the population by asymptomatic or untreated individuals with mildly elevated blood pressure is far greater than the sum of damage done to symptomatic individuals and those found by doctors to the journal of law, medicine & etbics have hypertension, for the latter group is much smaller. can changes in the environment affect the prevalence and distribution of hypertension in the population? only by comparing groups can scientists predict how individuals are likely to respond to elements of their social and physical environments. this is relevant to a number of legal issues. for example, in understanding the nature and impact of discrimination, we may recognize that the phenomenon at a population or social level cannot be well understood simply by looking to discrete cases of discriminatory behavior. indeed, epidemiological studies that have associated the relationship between discrimination in a population and the health status of minorities suggest precisely that point. epidemiology also teaches that the risks individuals face are significantly affected by their environment. for example, an individual with a low genetic predisposition to a disease may still be at a higher risk of that disease than an individual with a high genetic predisposition if the former is exposed to a more dangerous social and physical environment, where the incidence of the disease is tugher. from this we learn that even if our goal is to change an individual's risk factors, environmental or population-based interventions may be more successful than those policies that seek to change individual risk factors. epidemiology's analysis of the relationship between individuals and social risk also has relevance for a wide range of legal issues. for example, debates about whether government should enact apparently paternalistic laws, such as those requiring motorcycle helmet laws, often presume that individuals can make independent choices and that they can control the probabilities of their being affected by different risks.'" rose's work questions that assumption and provides legal decision makers with a different perspective for analyzing so-called paternalistic laws. on the one hand, a seat belt law niay not actually be paternalistic, if we recognize that inciivicluals cannot in fact control the risks to which they are exposed. on the other hand, such laws may be inefficient ways of reducing highway deaths if in fact they focus on altering individual rather than population behavior. as beauchamp and steinbock argue, "[tlhe population perspective constnicts a new story about how highway injuries occur in likewise, a population-based perspective may alter the way we understand relatively new issues, such as the legal responsibility of the food industry for the growing obesity epidernic.lo the traditional individualism of american law (and culture) would suggest that in the absence of misrepresentation or the sale of an exceptionally dangerous product, the food industry should not be viewed as responsible for the pr b em.l~~ individuals should be regarded as free and responsible for their own eating and exercising habits as well as the weight gain that ensues.""' a population-based perspective, however, questions whether individuals should be viewed as personally responsible for their own weight. after all, the prevalence of obesity is increasing both across the broad u.s. population and across varied sub-populations.iw likewise, the health damage stretches across the population, harming individuals who do not consider themselves in need of weight control or who do not meet the official definition of obesity (bmi greater than ). in fact, more health damage is likely occurring in the part of the population not identsed as overweight than in the overweight population.' this suggests that causes must be understood at a broad, population level. something is happening to make millions and millions of people make "choices" that lead to their gaining weight. epidemiologists, therefore, are looking to fundamental environmental changes, including the marketing and distribution of food, as well as the way our built environment affects our activity levels.' these deeper causes may suggest legal causation should be seen as residing in those parties (corporate and governmental) that perpetuate the obesity-causing environment, or it may suggest a role for affirmative government interventions to alter the environment.im while adoption of a populationbased perspective does not provide a single or simple determinative analysis of where and how the law should assign responsibility and intervene in the case of obesity, it does suggest a different set of remedies and approaches than would be offered by a more individualistic, marketbased approach, which might focus solely on remedying market failures by giving individuals more information on how to make healthy choices. importantly, epidemiology also teaches us that populations differ and that it is critically important to define and compare them. thus in thinking about obesity, or any other issue, we need to take care to consider what constitutes the population at issue. lawyers, however, often use terms like "the public good" or "majority" without defining the group or assessing how one group differs from others. this lack of precision may inappropriately privilege majorities (as may occur when courts uphold drug testing for school children on the unproven assumption that it is in the public interest),iw or it may devalue their interests by simply not treating them with sufficient rigor and import. a population-based perspective would not necessarily lead a judge either to uphold or bar a drug search, but it would demand that the "public" cited in defense of the search would be carefully delineated and the relationship between it and the search would be articulated. ultimately, a population-based perspective offers valuable lessons about the complexity of the relationship between individuals and populations. the history of public health is replete with examples in which individual interests have conflicted with either real or purported interests of particular publics. however, public health also teaches us that not only are individual interests interwoven with public conditions,"l but that recognition and protection of individual interests may also at times be the most efficient ways to secure a common good. early in the aids epidemic, it was noted that societies that respected individual rights were often the same ones which achieved individual behaviors most protective of tlie whole population."* (wealth and security, it should be said, often predate individual rights and explain tlie ability of people to lean and change behavior.) these perspectives from public health are important to understancling laws (statutory, regulatory, and common law) that purport to serve the common good. in almost all such cases, a lawyer's understanding of the population perspective will add to and enrich the legal analysis. whether drafting an administrative regulation to control air pollution levels or litigating a class action employment case, a lawyer's ability to take populations seriously and recognize the dynamic and multivariate relationship they have to individuals will improve the analysis. the true integration of piiblic health into legal education will not be easy to achieve. law schools have for the most part been quite reluctant to embrace change."' pressures from bar examiners iindoubtedly exacerbate that recalcitran~e."~ in addition, curricular changes require an investment of faculty time, that they may well be unwilling to make without sufficient institutional scippo~t."~ the most critical factor, however, may ix the existence, or lack thereof, of :in engaging :incl intellectu:rlly stimulating body of scholarship using the insights of public health to address a range of legal issues. attendees at tlie public health literacy for lawyers conference agreed that public health will not be integrated into the core legal curriculum unless and until a hotly of legal scholarship demonstrates its relationship to law and its power to enhance legal analysis. if such ;i body exists, then there is reason to hope that law professors will take note. neo-classical economics, for example, became part of legal education only after scholars, such as ronald coase and richard posnerl" produced scholarship that displayed the ability of neo-classical economics to provide a coherent, iinsed, descriptive, ancl nomtive analysis of a wide-range of legal problems. the breadth and apparent elegance of their approach helped to stimulate excitement and debate among legal scholars, spurring additional scholarship on the role of economic reasoning in the a s a result, even critics of the distributional consequences of law and econonucs came to see econoniic analysis of tlie law :is a perspective and skill that their students "ought" to know. to permeate legal education with population-based legal analysis, a similar scholarly revolution investigating the utility of incorporating concepts from public health science is needed. perhaps it has already begun. in recent years, there has been a renewed interest in public health law (including this secondjlmesyniposiiim). book-length expositions of the field have been and seven major conferences have been held. in addition, issues such as bioterrorism has spurred considerable scholarly delxtte.'" but few scholars have consciously attempted to explore the broader utility of population-based analysis for law and jurisprudence. perhaps, one by one, cases and courses iiiust be reexamined to assess the value of population-based legal analysis. to reach a wider audience, and to entice a critical mass of scholars to join the debate and bring it to their students, more and in-depth scholarship is certainly needed. as we noted at the start, public health's focus on populations, resting on the science of epidemiology, provides a valuable prism for understanding the relationship of individuals and groups and the ways that laws can and ought to affect the~ii.'~' in addition, analyses of morbidity and mortality, and health measures, may well provide an important complement or even alternative to wealth maximization as a measure for determining utility for a population.' grounded in observation ancl association, rather than on a singular deductive construct, public health science is unlikely to offer the kind of elegant, unified theory for human behavior spelled out in neo-classical economics, a theory that reminds us of h.l. mencken's suggestion that "for every problem, there is one solution which is simple, neat and wrong." nevertheless, public health can provide an alternative way of looking at old legal issues. for example, it may help lawyers analyze key issues, such as what constitutes the public good, and what are the proper roles and powers of government, where current answers are not wholly satisfactory. in order for public health to play this role, more scholars must join the field. they must explore and debate what it means to consider legal issues through the prism of public health. we expect that once they take up that baton, they will find that it leads them down interesting and as yet unpredictable paths. we hope they will join us on that journey. references see, e.g., guide to comintinity preuentimseryices, at <http://www.thecoi~iiiinityguide.org> (last visited october , ) (showing legal interventions as among the most effective proven interventions for community health). in recognition of this, the centers for disease control and prevention established a public health law program in w. see centers for disease control and prevention, hcblic heulth luw progrum, at <http://www.plippo.cdc.gov/od/ phlp/almiit.asp> (last visited october , ) . a. robbins and p. freeman, "public although we dmw from the discussions at the april conference, the views and errors here are solely are own. a list of jd/mph programs appears at cdc, public health program, public health practice program ofice, training and education in public health law, at <www, phppo.cdc.gov/od/phlp/education.asp> (last visited october , ) . for a discussion of the growth of combined degree programs in generdl, see l.r. crane, "interdisciplinary combined-degree and graduate law degree programs: history and trends," john marshall law . . rw~uu, ( ): - . . goodman, supra note , at - . see university of the pacific, mcgeorge school of law, capital center, bioterrorism, national security & public health law initiative: models for teaching, at <http:// www. mcgeorge.edu/government-law-and-policy/ bioterrorism/models-for-teaching.htm> (last visited october , ) . the public health advocacy institute, intends, as part of its public health literacy for lawyers project, to produce model materials for one or more core law school courses. m. minow, "education for co-existence," arizona why justice is good for our health: the social determinants of health inequalities uniuersity of chicago law review lochner the rise and fall of the constitutionalization of public health judicial power and reform politics: he anatomy of lochner v the role of new federalism and public health united states v. lopez judicial review under the commerce clause inside the federalism cases: concern about the federal courts parmet supra note judicial review of fda authority to regulate tobacco products as "drugs ( ) (city violated the fourteenth amendment when in the name of public health public health literacy for luwpts: selecting the content, paper presented at public health litmcy forluwym how science works epidemiology, justice, and the probability of causation burden of proof: judging science and protecting public health in (and out od the courtroom a fish out of water: scientisrs in court shattuck lecture -evaluating the health risks of breast implants: the interplay of medical science, the law, and public opinion galileo'sreuenge: junk science in the courtroom see also kuinho tire co complex litigation at the millennium: upsetting the balance between adverse interests; the impact of the supreine court's trilogy on expert testimony in toxic tort litigation is science different for lawyers . the science, technology and law panel created by the policy division of the national research council was established to "bring the science and engineering community and the legal community together law, politics, and the claims of community rights talk: xbe impoverishment atoinism the the y of hgtilation of civil government: two treatises feminist perspectives and the ideological impact of legal education on the profession thinking beyond my own interpretation: reflections on collaborative and cooperative learning theory in the law school book review -lawrence . gostin's seton half law review groups and the equal protection the failure of gender equality: an essay in constitutional dissonance individual rights and class discrimination: the fallacy of an individualized determination of disability , (striking down admissions program for state university in which applicants were given specific admissions points based upon their race) holding that state policy that foreseeably disadvantaged women did not violate the constitution) holding that police exam that disparately excludes african american applicants from police force does not violate the constitution unless the defendant city intended to discriminate) scientific policymaking and the tom revolution: the revenge of the ordinary observer prima facie torts, combination, and non-feasance at (attributing the nile to an ideology of individualism). the most iduential scholar/judge advocating this view has been judge richard posner science, reason, csr ton law hateful speech, loving communities: why our notion of "ajust balance philosophy and the human sciences: philosophical p a p , wl spheres of justice: a oefense of pluralism and stanford law jacobi, supra note he strategy of premniim medicine integrating law and social epidemiology twenty-five states have repealed mandatory helmet laws for motorcycle riders over twenty-one years of age since the highway safety act of removed the department of transportation's authority to condition federal highway hnding on helmet-use laws. national highway safety administration ) (noting that obesity has become an epidemic in the united states and listing associated liealth problems). the public health advocacy institute using the absurdity of regulating the marketing of fast food because of its impact o n obesity as a justification for denying the state the right to regulate the marketing of tobacco) macdonald's ing that consumers could not bring a claim against macdonald's holding it responsible for their weight, as their decision to eat there was their own free choice ) (holdmade by the center for consumer freedom, an industrysupported group that objects to legal liability for the food industry the gorge yourself environment public health service, ofice of the surgeon general, he surgeon general's call to action to prevent and decrease ooenoeight and obesity the ideal population policy would be a substantial and general weight reduction environmental conuibu-' tions to the obesity epidemic for a discussion of the relative merits and demerits of tort litigation and regulatory approaches to public health, see the relationship between student illicit drug use and school drug-testing policies medicine and public health, ethics and human rights the problem of social cost the firm, the market, and the law he economic structure of tort law the ecoiiomics oflustice economic analysis of laui the inefficient common law is wealth ;i value problem-solving behavior and theories of tort liability public health pmcfice bioterrorisni, public health and civil liberties public health law in the age of terrorism: rethinking individual rights and common goods see text accompanying note supra. . this is not to say that any of these measures can or should be the sole way of judging welfare maximization, but they do provide an interesting alternative to the economist's tendency to reduce all issues to questions of wealth key: cord- - ulk euw authors: wang, jianming; fei, yang; shen, hongbing; xu, biao title: gender difference in knowledge of tuberculosis and associated health-care seeking behaviors: a cross-sectional study in a rural area of china date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: ulk euw background: tuberculosis (tb) detection under the national tb control program in china follows passive case-finding guidelines, which could be influenced by the accessibility of health service and patient's health-care seeking behaviors. one intriguing topic is the correlation between men and women's knowledge on tb and their health-care seeking behaviors. methods: two cross-sectional studies were separately carried out in yangzhong county, a rural area of china. one study, by using systematic sampling method, including , subjects, was conducted to investigate the tb knowledge among general population. another study in the same source population screened , people aged years or over among stratified cluster-sampled villages for identifying prolonged cough patients at households and individual interviews were then carried out. gender difference in the knowledge of tb and health-care seeking behaviors was analyzed particularly. results: among general population, only . % (men . % vs. women . %) knew the prolonged cough with the duration of weeks or longer was a symptom for suspicious tb. fewer women than men knew the local appointed health facility for tb diagnosis and treatment as well as the current free tb service policy. moreover, women were less likely to learn information about tb and share it with others on their own initiatives. on the contrary, after the onset of the prolonged cough, women ( . %) were more likely to seek health-care than men ( . %) did. however, a large part of women preferred to visit the lower level non-hospital health facilities at first such as village clinics and drugstores. conclusion: tb and dots program were not well known by rural chinese. gender issues should be considered to reduce diagnostic delay of tb and improve both men and women's access to qualified health facility for tb care. strengthening awareness of tb and improving the accessibility of health-care service is essential in tb control strategy, especially under the current vertical tb control system. tuberculosis (tb) is a leading cause of death world-wide, especially in low-income and middle-income countries [ ] . although tb prevalence and death rates have probably been falling globally for several years, the total number of new cases is still rising slowly, due to the caseload continuing to grow in the african, eastern mediterranean and south-east asia regions [ ] . china has the world's second largest number of tb cases [ ] . to fight against tb, the chinese national tb control program (ntp) has adopted the directly observed treatment, short course (dots) strategy since [ ] . however, the progress in tb control was slow during the s, resulting in the detection rate of tb stagnating around at %, far below the target set by world health organization (who) [ ] . recently, especially after the outbreak of severe acute respiratory syndrome (sars) in , the chinese government has taken a series of measures to strengthen its public health system and put great efforts on tb control. however, as a country with large populations, china is still facing great challenges, especially in rural areas. one of them is the accessibility of tb services toward the entire population [ , ] . although china's ntp has set a free tb service policy, in most places access to tb care is still unsatisfactory. tb control system in china is vertically composed by specialized tb dispensaries and tb control departments from county/district level to national tb center. the basic unit of tb control in rural china is the county tb dispensary which is the main place for dots implementation. as case detection in the ntp in china follows who recommended passive case-finding guidelines, people with tb related symptoms should be identified when they seek care at a general health facility, and referred to the specialized tb dispensary for diagnosis, treatment and case management. therefore, early detection of tb depends on whether patients could perceive their needs of seeking health-care for tb symptoms such as cough; and whether patients could be promptly referred to tb dispensaries by doctors in general hospitals and other health providers [ ] . however, under the current fee for service and bonusrelated revenue mechanism in china's health system, it is not surprising to find that the referral does not work well in many places [ ] . thus, making people understand when and where they should seek health-care is of great importance. several studies have proved that lack of knowledge to tb is likely to hinder positive health-care seeking behavior whilst better knowledgeable on tb was significantly related to health-care seeking action [ ] [ ] [ ] . studies also found that there was gender difference in knowing tb. as reported by agboatwalla in pakistan and shetty in london, knowledge of tb was generally deficient in women, particularly in rural women [ , ] . gender disparity is focused world-wide as higher notification rates of tb among men than women have been observed in many countries [ ] . these findings raise the hypothesis that tb among women might be underreported in developing countries. it has been supported by the results from several studies comparing active and passive case-finding strategies [ ] . one study in bangladesh reported that women, in comparison with men, had significantly longer diagnostic delay and patient delay [ ] . similar results could be found in shandong province of china, where women experienced longer health system delays than men, and that the higher the level of health facility patients first visited, the less time was needed to achieve a diagnosis [ ] . our former qualitative study in china also found a gender disparity in the experiences of health-care seeking and access to tb care [ ] . factors affecting patient's behavior were complex. whether the gender difference in health-care seeking behavior is associated with the disparity of knowledge to tb among men and women is unclear. few studies have been focused on this issue. the purpose of the present study was to understand whether and what extent people in rural china know tb and aware of the pro-poor dots program, and further to understand the collation between rural people's knowledge and awareness of tb and their health-care seeking behaviors from a gender perspective. this study was conducted in yz county, an island locating on the middle of yangtze river in the southeast part of china, with a population of about . million and an area of about km . this is a relatively rich area ranked as one of the richest counties in china. the county tb dispensary is affiliated to cdc (center for disease control and prevention), which was formerly called anti-epidemic station. it is the exclusive appointed health facility responsible for tb diagnosis and treatment for the county residents (county hospital is appointed for severe inpatients). all suspected tb patients should be referred to this unit for further examination. free diagnosis and treatment are available in tb dispensary for sputum smear positive patients (it has been expanded to all patients including sputum smear negative patients since ). here, 'free' means no charges for sputum smear test, chest x-ray examination and anti-tuberculosis medications distributed by government. all other health facilities in this county including township health centers, private practitioners and village health stations are responsible for referring tb suspects to the county tb dispensary, and smear microscopy tests and anti-tuberculosis medicines are not available in these facilities. two cross-sectional studies were separately conducted in the study site. ( ) knowledge on tb among general population sampling strategy in the current study followed the guidelines designed by china cdc. after sorting all towns in yz county by socioeconomic status (gross domestic product), towns were selected at the first stage by using a systematic sampling technique. then villages from each town were systematically sampled. at the third stage, households were systematically sampled from each village based on the list of householders' names. in each household, two family members (aged to ) whose birthday (month and day) was close to the investigation date (month and day) were selected as study subjects and were then interviewed by trained investigators with a detailed questionnaire. this questionnaire we adopted in the study referred to the questionnaire designed by china cdc, which has been applied in a national survey on the knowledge, attitudes and practices (kap) towards tb in china [ ] . ( ) health-care seeking behaviors among tb suspects among the same source population, a stratified cluster sampling method was used to select sample units for tb screening. totally, villages were randomly sampled from towns (one town named as sm where the county center located was not involved in the sampling process). all permanent inhabitants aged years or over were the study population and then screened by using a simple questionnaire for identifying people at each household with prolonged cough which was a main symptom for tb. a detailed structured questionnaire was then administered for all identified cough cases to collect socioeconomic and demographic variables, symptoms other than cough and health-care seeking behaviors. these patients with prolonged cough were regarded as tb suspects and were then referred to cdc for free x-ray examination and sputum smear microscopy test. in this study, delays in tb diagnosis are generally divided into 'patient delay" and 'system or service provider delay'. 'patient delay' refers to the time between the first onset of symptoms and first utilization of a healthcare provider, whilst 'system delay' refers to the time between the first utilization of a health provider and a confirmed diagnosis of tb [ ] . data were analyzed by spss . software (chicago, illinois, usa). chi-square test for proportions and student's t-test and kruskal-wallis h test for continuous variables were used to describe differences between groups. about % of all cases were randomly selected to be re-inter-viewed through telephone by the supervisor after field investigation. in this study, a prolonged cough was defined as the cough lasting for weeks or longer. healthcare seeking behaviors included buying drugs in pharmacies and visiting private practitioner, village health workers, physicians in town, county or upper level hospitals and the county tb dispensary. formal health-care seeking was exclusively defined as the experience of visiting town or upper level hospitals. health-care seeking delay referred to a period from the onset of symptoms to the first utilization of a health facility. oral inform consent was obtained in the study on the knowledge of tb among general population. written inform consent was obtained from all participants in the study on health-care seeking behavior among tb suspects. the study was approved by institutional review board in school of public health, fudan university. one thousand and two hundred adults were selected for the survey of knowledge on tb and subjects completed the questionnaire. the proportion of men and women were . % and . % respectively, with the average age of . ± . years. the median annual income per capita was around cny (chinese yuan). as shown in table , . % of the subjects have heard about tb and a large part of them regarded it as a contagious disease (men . %; women . %). many of them thought tb was a relatively severe disease, which could influence the labor ability. about . % of them actively acquired information about tb and . % of them shared it with others on their own initiatives. significantly more men than women actively learned knowledge about tb (men . % vs. women . %, p < . ). sixteen percent of them (men . % vs. women . %) understood that the prolonged cough with the duration over weeks was a suspicious symptom for tb. when inquired about the current tb policy in yz county, . % (men . % vs. women . %, p < . ) answered that they knew about the appointed health facility for tb diagnosis and treatment. less women than men knew the local policy for free tb service with a significant gender disparity. approximately . % women vs. . % men (p = . ) knew that it was free for tb diagnosis as well as . % women vs. . % men (p < . ) knew that it was free for tb treatment in the local county. only . % (men . % vs. women . %) believed tb was a curable disease at the present time. by screening , people ( , men and , women), subjects were notified with a prolonged cough within the past three months. after recheck, patients were excluded due to the short durations of cough. another former tb patients diagnosed three months ago were also excluded. finally, subjects ( men and women) identified as tb suspects were involved in the analysis. as shown in table and table , . % of them had sought for health-care during the current cough episode and only . % of them went to the town hospital or upper levels seeking for formal healthcare. nearly . % of them firstly visited village clinics or drugstores after the onset of cough. the median of house-hold per capita income was cny and cny respectively in the group with or without seeking healthcare (p = . ). more women than men sought healthcare for the current prolonged cough with a significant gender difference (women . % vs. men . %, p = . ). however, men preferred to visit upper level health facilities first, whereas women preferred to visit lower level health facilities first (table ) . even in the second health-care seeking episode, this gender difference still existed. the median of delay from the onset of symptoms to the first visit at health facility was days. there was no with the vertical tb control system, dots program characterized by the free tb diagnosis and anti-tuberculosis treatment is only available in tb dispensary. in rural areas, the lowest level of tb control system is the county tb dispensary where patients with cough and/or other tb symptoms do not routinely visit. in the context of china's tb control policy, it's not possible to see this system being replaced by the non-specialized health facilities in a near future. so the accessibility of dots in china relies on referral by doctors in general hospitals, and/or self-referral by patients. to empower patients, and to make people understand when and where they should seek health-care, chinese government has initiated a massive education program on tb in general population, especially people living in the rural areas. one of the objectives of this education program is to help potential tb patients identify the suspicious symptoms and go to the right place for treatment in time. either in the urban hospitals or in the remote rural health facilities (even in the village health station), there are posters on the wall, such as 'if coughed for more than weeks, you are suspect for tb', 'the government provides free treatment for communicable tb' and 'local cdc (tb dispensary) provides free service for sputum smear test, chest x-ray and anti-tuberculosis medicines'. this information also spread through other vivid and dramatic manners such as newspaper, website, television, broadcast, brochure and leaflet. people would argue that it does not sound reasonable to expect non-patients and/or potential patients to know where to go for tb diagnosis and treatment, but it's a compromise to the vertical tb control system. theoretically, the health staff that tb patients encounter should refer them to the correct place for diagnosis and treatment, where dots program is available. however, this referral system does not work well in many places [ , ] . as we know, under china's health system reforms, hospitals and other health facilities have adopted fee for service and bonus-related revenue systems to encourage their medical staffs to make more money [ ] . it is not surprising, therefore, that these health facilities have been developing a variety of means to attract patients in order to generate more revenues by providing more services and selling more drugs [ ] . it is also common to see that, repeated outpatient visits before diagnosis, over-prescription of drugs and prolonged treatments instead of referral to appointed health facilities in time [ ] . admittedly, the heavy financial burden on tb patients is one of the major problems in china's tb control which has been the main reason for poor access to tb care and treatment compliance. pressure to generate revenue and competence of health workers at different levels cause diagnostic delay and high economic burden to tb patients and ultimately impede effective tb control in china [ ] . but, if patients know tb diagnosis and treatment should be free, they would have more chances to ask why they should pay for tb care and what cost should be covered by the free care. therefore, on one hand, regulating doctors' referral could be effective to shorten diagnosis delay for tb; on the other hand, educating general population to seek health-care in an appropriate way is also an alternative. massive health education programs in china have been proved to make a great impact on the enhancement on people's knowledge about tb. from the current study, we are also glad to find that almost all people have heard about tb and more than % knew it was a transmissible disease. however, knowledge about tb linked with health-care seeking behaviors still seems unsatisfactory. only % of them knew that cough lasting for more than weeks was a suspicious symptom for tb and less than half of them knew the free policy for tb diagnosis and treatment. the incomprehensive perception on tb among general population after the massive education program arouses our consideration on the health educations in china: whether it is a successful campaign and what is the cost-effective way? one interesting result in our study is that the gender disparity of knowledge towards tb among men and women was inconsistent with the health-care seeking behaviors. compared with men, women lacked knowledge about tb symptoms and the pro-poor service policy. however, they were more likely than men to seek health-care after the onset of tb suspicious symptoms. as proved in several studies, deficient knowledge in women and patient's recognition of tb were statistically significant factors of diagnostic delay for tb [ , ] . a study in rural inner mongolia of china also reported that women with less education tended to be less knowledgeable about tb and were less likely to seek care than men though gender difference was not statistically significant in the quantitative survey [ ] . in our current study, lack of knowledge among women did not show negative impacts on their health-care seeking. this phenomenon could also be found in south india that despite facing greater stigma and inconvenience, women were more likely than men to access health services and adhere to treatment [ ] . however, when we take a deep look on the data and further explore their health seeking experiences, it is not surprised to find that men and women have different preference on the health-care service. men preferred to visit upper level health facilities -the hospitals, whereas women preferred to visit lower level health facilities such as village health stations. as proved by other studies, patients who chose the village clinic or private providers as their first health facility usually experienced a much longer health system delay than that of those choosing other formal heath facilities [ , ] . thus though women were more likely to seek health-care for tb suspicious symptoms, it might not help shorten the health system delay due to the weakness in diagnosis in non-formal health facilities. there are several explanations for this phenomenon. one might be the deficient knowledge on tb we discussed above. another might be the special role of women in china. in rural areas of china, most work in the household is undertaken by women in addition to agricultural work, which may mean that they have less time seek health-care in a township health center or general hospital. women may therefore prefer to visit facilities that are geographically accessible such as village health stations or private practitioners. another intriguing phenomenon found from this study also need to be further studied, which was that, though free service was provided to the identified cough patients, some of them were still not willing to get further examination. when inquired about the potential reasons, some patients answered "free? i don't believe it. after examination, i am sure they will administrate many drugs and charge me a lot", and others said "that is only cough. i know it will not be a serious disease..." more reasons undermining this aspect need further studies. one of the limitations in this study is that data were only collected from one county, which might not truly reflect the vision of the whole population in china. though the study is very small, and findings from this study may not be comprehensive, it does have impacts on gender equity in tb control of china. another limitation is that information depended on self-reported data and the survey on health-care seeking behavior was based on recall history. to minimize recall bias, some strategies had been taken, such as questionnaires were pre-tested and all questions were set to be easy understood; investigators were carefully trained and supervised. ten percent of subjects were re-interviewed through telephone and the consistency was more than %. findings from our study indicate that knowledge and awareness of tb are still unsatisfactory in rural chinese population. compared with men, women have less knowledge on the current tb service policy and reluctant to actively acquire information about tb. though they are more likely to seek health-care after the onset of prolonged cough, women usually visit village clinics or drugstores whilst men prefer to seek health-care in upper level hospitals. gender issues should be considered in promoting patients' health-care seeking behavior and to shorten the delay of diagnosis. improving the accessibility of healthcare service is essential in tb control strategy, especially under the current passive case-finding guidelines. results of this study are derived from a rural population of china, but could be discussed also in relation to other populations with the similar condition. global tuberculosis control -surveillance, planning, 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among rural vietnamese adults with a cough for at least three weeks gender perspectives on knowledge and practices regarding tuberculosis in urban and rural areas in pakistan abbas a: knowledge, attitudes and practices regarding tuberculosis among immigrants of somalian ethnic origin in london: a cross-sectional study gender differences in tuberculosis: a prevalence survey done in bangladesh a review of sex differences in the epidemiology of tuberculosis gender differences in delays in diagnosis and treatment of tuberculosis. health policy and planning factors affecting delays in tuberculosis diagnosis in rural china: a case study in four counties in shandong province perceptions and experiences of health care seeking and access to tb care-a qualitative study in rural jiangsu province, china. health policy gong gong wei sheng yu yu fang yi xue pathways from first health care seeking to diagnosis: obstacles to tuberculosis care in rural china how affordable are tuberculosis diagnosis and treatment in rural china? an analysis from community and tuberculosis patient perspectives gender and literacy: factors related to diagnostic delay and unsuccessful treatment of tuberculosis in the mountainous area of yemen perceptions of tuberculosis and health seeking behaviour in rural inner mongolia, china. health policy gender disparities in tuberculosis: report from a rural dots programme in south india delay and discontinuity-a survey of tb patients' search of a diagnosis in a diversified health care system this investigation partly received financial support from the undp/world bank/who special program for research and training in tropical diseases (grant no. who/tdr/seb a ) and natural science foundation of jiangsu (bk ). thanks for the support of shanghai leading academic discipline project (b ) for publication. the authors declare that they have no competing interests. jw and bx conceived the idea, implemented the field study and wrote the manuscript. yf participated in the design and implement of the study and statistical analysis. hs participated in data analysis and helped to draft the manuscript. all authors read and approved the final manuscript. the pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/ - / / /pre pub key: cord- - z cm authors: zou, kelly h.; li, jim z.; salem, lobna a.; imperato, joseph; edwards, jon; ray, amrit title: harnessing real-world evidence to reduce the burden of noncommunicable disease: health information technology and innovation to generate insights date: - - journal: health serv outcomes res methodol doi: . /s - - - sha: doc_id: cord_uid: z cm noncommunicable diseases (ncds) are the leading causes of mortality and morbidity across the world and factors influencing global poverty and slowing economic development. we summarize how the potential power of real-world data (rwd) and real-world evidence (rwe) can be harnessed to help address the disease burden of ncds at global, national, regional and local levels. rwe is essential to understand the epidemiology of ncds, quantify ncd burdens, assist with the early detection of vulnerable populations at high risk of ncds by identifying the most influential risk factors, and evaluate the effectiveness and cost-benefits of treatments, programs, and public policies for ncds. to realize the potential power of rwd and rwe, challenges related to data integration, access, interoperability, standardization of analytical methods, quality control, security, privacy protection, and ethical standards for data use must be addressed. finally, partnerships between academic centers, governments, pharmaceutical companies, and other stakeholders aimed at improving the utilization of rwe can have a substantial beneficial impact in preventing and managing ncds. noncommunicable diseases (ncds) are the leading causes of mortality globally and a major global health challenge that affects people in all countries, regardless of their socioeconomic status (world health organization ; gbd disease and injury incidence and prevalence collaborators ) . approximately % of ncd-related deaths are considered premature, occurring before the age of years, and approximately % of premature deaths occur in low-and middleincome countries (world health organization ) . however, the prevalence of many ncds increases with age (gbd disease and injury incidence and prevalence collaborators ; global burden of disease study collaborators ). the continued growth of the aging population, which is often pronounced in developed economies with relatively advanced healthcare systems, will increase the prevalence of ncds and accentuate disease burden. the world health organization (who) has identified main types of ncds that contribute the greatest burden. they are cardiovascular diseases (cvds), cancers, chronic respiratory diseases, and diabetes ( fig. ). in , ncds accounted for % ( million) of deaths worldwide, with % of these deaths attributable to cvd, % to cancer, % to chronic respiratory disease, and % to diabetes (world health organization ). in the us, cvd accounted for approximately of every deaths that year (benjamin et al. ). in addition, neurological conditions and mental health disorders, such as anxiety disorders, migraine, major depressive disorder, bipolar disorder, and alzheimer's disease, have emerged as major causes of disability (global burden of disease study collaborators ). indeed, mental health and well-being have been highlighted by the united nations as important components of the goal to reduce premature mortality from ncds by % over the next years (united nations ). ncds are characterized by their long duration or continual recurrence (i.e., chronic) and slow progression, and many ncds have high prevalence. for example, hypertension alone is diagnosed in over % of adults in a vast majority of countries across north america, latin america, europe, asia, africa, and oceania (clarivate analytics ). ncds are also major causes of morbidity and disability, including anxiety, depression, pain, and mobility impairment (lisy et al. ) . data from the global burden of disease study showed that the most common chronic sequelae, as consequences of disease, are largely attributable to ncds (global burden of disease study collaborators ). those who are most socioeconomically disadvantaged are often at a high risk of developing ncds (murray et al. ; marmot and bell ; nulu ) . furthermore, in the era of covid- , ncds pose an even greater threat. according to the centers for disease control and prevention, "people of any age with the following conditions are at increased risk for covid- : cancer; chronic kidney disease; chronic obstructive pulmonary disease (copd); immunocompromised state from solid organ transplant; obesity (body mass index [bmi] of or higher); cvd; sickle cell disease; and type diabetes mellitus" (centers for disease control and prevention ). the economic costs of ncds are burdensome to countries around the world (bloom et al. ) . besides ncd treatment and control, the negative impact also includes the reduced productivity at work, more days absent from work (absenteeism), and early retirement, both for individuals with ncds and due to premature death. these costs can lower family economic status, as well as national economic output. furthermore, national funds that need to be deployed toward treatment of ncds take away the funds that might otherwise be invested in infrastructure, research, and education (chen et al. ) . studies also suggest that the medical and economic burdens due to ncds, which are already high, continues to increase, especially in less-developed economies, as well as in middle-and high-income countries (global burden of disease risk factors collaborators ; timmis et al. ). therefore, how the social determinants of health (sdoh) affect ncds is an increasingly important area of focus (marmot and bell ) . governments around the world and international organizations, such as the world bank and who, are increasingly committed to ncd prevention and control (world health organization ). efforts to reduce the burden of ncds are increasingly shifted from treatment to prevention. this is because the majority of ncds occur as a result of modifiable risk factors. therefore, reducing and controlling these risk factors is an effective means of reducing the burden of ncds. the who has called for ncd prevention efforts to focus on the following modifiable behavioral risk factors (tobacco use, physical inactivity, the harmful use of alcohol and unhealthy diets; fig. ) and metabolic risk factors (raised blood pressure, overweight/obesity, hyperglycemia, and hyperlipidemia). prevention not only reduces ncd-related suffering to patients but is also more cost-effective to societies. for example, programs targeted at preventing or treating ncds can have a significantly beneficial effect, with recent estimates suggesting that every us $ spent on tackling ncds will have a return of at least us $ in the following years (world health organization ). a global comprehensive approach is needed to reduce the burden of ncds, which requires the collaboration across various sectors, including academia, industry and governments (upjohn ). this approach should reduce the risk factors for ncd and promote interventions to prevent and control ncds and is especially important during the covid- pandemic (hassan et al. ) . organizations such as the who have realized the importance of innovative data visualization to help educate on both the importance of reducing the global burden of ncds and the stopping the spread of the covid- during . real-world data (rwd) and real-world evidence (rwe) play an important role for international organizations, governments, and societies, helping them to make informed decisions regarding ncd prevention and control. according to the us food and drug administration (fda), rwd means data collected outside of the framework of randomized, controlled trials (rcts) (us food and drug administration ). furthermore, rwe is generated through the analysis of rwd and is used to answer specific clinical and research questions. the lack of rcts designed to assess the burden and degree of the comorbid conditions occurring with ncds means that rwe is the greatest resource available to study this important area. global advances in information technologies and telecommunication infrastructures have enabled a massive amount of rwd to be generated from diverse data sources. the wide variety of data sources include pharmacovigilance databases, electronic medical records (emrs) including medical images/imaging data and free-text notes from healthcare providers, electronic health records (ehrs), administrative insurance claims, patient registries, population health surveys, medical researches including genomics studies, data collected from digital apps and digital recording devices including wearable devices, and various other sources (fig. ) . rwd can be claims and transactions for healthcare resource utilization, electronic health records, surveys, linked datasets, and other digital data collected outside a traditional clinical trial. because rwd can be generated at a low cost (relative to rcts) and rapidly (e.g., streamed from wearable devices), it is often stored and processed in considerable quantity. thus, it can be so-called big data due to its "volume" (there's a lot of it), "variety" (the data takes many different forms), "velocity" (the data changes or are updated frequently) and "veracity" (the data may be of poor/unknown quality) (ibm ; seth ). the immense potential value of data in the modern world has led to it being described as the "the new oil" (the economist ). pharmaceutical companies are now investing in their rwe programs to increase their capabilities in this arena, across all aspects of the drug development and approval process (deloitte ; davis et al. ; morgan et al. ). rwe is the foundation for the understanding of disease epidemiology, including rates of disease incidence and prevalence, awareness, diagnosis, treatment, and control. rwe plays a critical role in quantifying disease burden, which can be measured according to the following aspects: patients' lives saved/lost, gain/loss of daily function, work productivity, and income; quality of life; healthcare resource usage. rwe can also be used to detect vulnerable populations (e.g., elderly and persons at high risk of ncds) and identify the most influential risk factors, which may lead to new and non-traditional solutions to clinical problems (batra and cheung ) . recently, rwe has been increasingly used in the regulatory arena for gaining label expansion, as well as accelerating drug approvals due to regulatory authorities now being more receptive to reviewing rwe (katkade et al. ; zou et al. ) . there is an opportunity to use rwe to study diverse populations that are frequently underrepresented in both clinical and observational studies. for example, patients who richardson et al. ; onder et al. ; hassan et al. ). these comorbid ncds such as cvd, chronic pulmonary disease and diabetes have also been demonstrated to worsen the clinical outcomes and increase the risk of death in those infected with covid- (docherty et al. ; bergman et al. ). this understanding can help deploy preventive strategies to identify people at most risk of contracting severe covid- . this will in turn avoid overburdening the healthcare system. finally, rwe can be used to measure and evaluate the effectiveness and cost-effectiveness of treatments, as well as programs targeting sdohs , and public policies for ncds. global and societal efforts to reduce the populations' risk of ncds (world health organization , ) can be supported by using rwe to monitor incidence and prevalence trends of ncds and risk factors, and to target prevention measures at populations that are vulnerable to ncds. on a larger scale, risk reduction and increased access to interventions can be attained through collaboration among public health policymakers, payors, healthcare providers, and patient groups. disease management can improve, as primary care providers adjust their treatment approaches, access to screening, detection, and treatment services, and more people have access to and can benefit from palliative care. the rationales for these changes will rely heavily on the availability and intelligent use of rwe. only when stakeholders clearly understand the context and implications of ncds can they begin to effect and direct changes. another important aspect to consider is regional and racial differences and variations of the prevalence of ncds and the various risk factors for these diseases (world health organization . this aspect can provide key information as to the effectiveness of local policy initiatives targeted at ncds as well as the influence of various factors and behaviors that could influence ncds, e.g., smoking and obesity (kontis et al. ; office of disease prevention and health promotion ). although rcts remain critical in determining treatment safety, efficacy, and mechanisms of action (collins et al. ) , their focus of patient selection and controlled clinical trial setting make it difficult to generalize the findings of rcts to real-world clinical practice, which often has many confounding factors affecting the effectiveness of the treatment (sherman et al. ). in addition, rcts often focus on the effects of a single disease on outcomes, rather than multiple related conditions, which given the high levels of cooccurrence of ncds, can be a limitation. furthermore, rcts are time-consuming and are becoming increasingly costly to conduct (baumfeld andre et al. ). this is especially true due to the chronic nature of the diseases being discussed. for example, patient followup in rcts is often insufficient to have a clear understanding of patient safety. in contrast, rwe allows a treatment's effectiveness and tolerability to be evaluated in real-world practice, and therefore, rwe is important to assess the long-term safety of medications and can help identify rare adverse events (collins et al. ) . furthermore, rwe provides tremendous opportunities to develop a more holistic understanding of patients and more effective approaches for comprehensive disease management. this is key to modifying patients' behaviors such as improving adherence with treatment, which in turn helps optimize outcomes (see below). while it is premature to suggest that rwe will replace rcts, rwe provides an important complementary mechanism to rcts for healthcare professionals seeking to find novel solutions to address the burden of ncds. for example, rwe has been used for many years to study adherence with medications to treat ncds and evaluate methods of improving adherence with these medications. poor adherence to medications to treat ncds is a major global issue. low adherence with treatment increases the morbidity and mortality burden of ncds, even in high-income countries (khan and socha-dietrich ; brown and bussell ; cutler et al. ) where effective therapies are available, disease burden can only be reduced if patients adhere to the treatment for the prescribed duration (world health organization ; shau et al. ) . improving patient adherence to existing interventions increases treatment effectiveness, resulting in significant overall cost-savings associated with disease burden. therefore, an additional key use of rwe in ncd prevention and control is to better understand how we can improve the complex issues surrounding treatment adherence and persistence (cramer et al. ) . to address this challenge, rwe can be used to estimate adherence and persistence rates and assess the factors associated with these rates . such information can be translated into realistic plans based on authentic insights to improve the proportion of patents adherent with their therapeutic regimens. the availability of rwd may depend on technology, digitization, data capture systems, and data flow regulations (us food and drug administration ). rwd is usually not collected for research purposes and thus can be messy and in many different formats or forms. data accuracy, reliability, and quality must be taken into account when using rwd for research (sherman et al. ) . to make the most of these research opportunities, innovative digital/analytic capabilities and technologies must be enabled and elevated globally for use by medical researchers serving in industry, government, and academia. given the variety of data sources for rwd, important issues arise around data integrity, integration, access, interoperability, standardization, quality control, security, privacy protection, and ethical standards for data use. informed consent is a key consideration in rwd. the us food and drug administration in its guidance for institutional review boards and clinical investigators states that "no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. an investigator seeks such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. the information that is given to the subject or the representative shall be in language understandable to the subject or the representative. no informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence" (us food and drug administration ). however, informed consent needs to be carefully examined and discussed. nevertheless, informed consent can limit the access to certain types of data or information from some regions. advances in the blockchain technology can also enable dynamic informed consent (mamo et al. ) . when data are available and in aggregate, cutting-edge innovations might be introduced to address such challenges. this is because, in order to be of any use, structured data (i.e., encoded in a standardized data format) and unstructured data (e.g., free-text physician notes) from various sources may be combined and curated into databases using interoperable systems, which can be complicated. this is further complicated when databases obtained from various divergent sources are housed in separate repositories and data warehouses, which creates a major barrier to accessing and collating the relevant data. language differences between countries also present a common challenge in this regard. furthermore, in many countries, data are collected and stored in siloed patient registries in non-standardized ways. these registries are often not connected with each other and contain diverse sets of information, which complicates analysis further. even within the same country, such as the united states, linking patient-level data across various sources can be problematic. sometimes this can be accomplished using tokens that are generated from certain subsets of patient protected health information under the health insurance portability and accountability act of (hipaa) rule (us department of health & human services , ; centers for disease control and prevention ). other times, linkage can occur according to dates or locations of the treatment (curtis et al. ) . in many instances, some level of probabilistic matching, such as propensity score matching, may be required across multiple data sources or datasets (desai et al. ). sensitivity analyses based on different probabilistic matches can be considered to examine the robustness of the matching algorithm. databases can also be difficult to standardize; different diagnostic and treatment codes need to be harmonized (observational health data sciences and informatics ). similarly, it is important to establish and utilize standard and specific analytical methods and algorithms. for example, the observational health data sciences and informatics (ohdsi) group is at the forefront of harmonizing and standardizing the analysis of observational data and has created a common-data model (hripcsak et al. ) . this, along with similar initiatives, will improve data reproducibility and the potential for groups to collaborate while working towards a common aim. an additional complication in the analysis of rwd can be data and privacy protection laws, such as the california consumer privacy act of (ccpa) (state of california department of justice ) or the european union general data protection regulation (gdpr) (european commission ), which will need to be considered carefully when utilizing data from the european union, even without containing personal identifiable information. moreover, when utilizing data from digital devices, it is necessary to consider how best to accurately combine data. for example, glucose monitors may not calculate summary measures in exactly the same way, which necessitates getting the raw data and using software package such as "cgmanalysis" in r to compute values in a consistent manner (vigers ) . once these initial challenges are addressed, robust data curation and analytic algorithms must be derived that are tailored toward specific patient populations. these algorithms will aid the identification of persons with, or at risk of, ncds and help to address the challenge of ncds throughout a patient's ncd journey, including detection, screening, diagnosis, treatment, and monitoring. to achieve this, the current shortage of data translators (who act as shepherds with subject-matter expert knowledge) and data scientists will need to be addressed. the medical and scientific insights gained through rwe-generation can potentially impact global policies to reduce the burden of ncds. in addition, rwe can help provide opportunities to analyze both cross-sectional and longitudinal data to assess and monitor the effectiveness of various interventions designed to target ncds and risk factors for ncds. there is a critical need to address the substantial burden associated with ncds. this is even more urgent in the covid- era given the increased risk of poor clinical outcomes in patients with ncds who become infected with covid- . some of the limitations associated with rcts, notably their often narrow focus, can be addressed by using rwd. therefore, over the coming years, we anticipate seeing more of the power of rwd and rwe being harnessed to address the immense healthcare burden associated with ncds. innovative techniques for both capturing and analyzing data will be utilized. for example, a distributed research network is useful for generating rwe. to enhance the effectiveness and efficiency of healthcare delivery, it is important to understand the risk factors for disease progression, treatment patterns, and utilization. educational initiatives regarding the potential for rwd and rwe to deliver patient-centric, value-base healthcare will lead to further improvements in the management of ncds. however, it is also important to strike the right balance of understanding the challenges and limitations of rwd and rwe to ensure that they are utilized correctly. finally, partnerships can play a key role in improving the utilization of rwe. fruitful collaborative research opportunities exist across different healthcare stakeholders, including academia, industry and government, based on health information technology and innovation for gaining valuable insights. this will, in turn, have a substantial beneficial impact on the 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boards and clinical investigators us food and drug administration: guidance for industry electronic source data in clinical investigations cgmanalysis: clean and analyze continuous glucose monitor data health statistics and information systems: disease burden and mortality estimates noncommunicable diseases (ncds) and mental health: challenges and solutions adherence to long-term therapies world health organization: global action plan for the prevention and control of noncommunicable diseases noncommunicable diseases: key facts an acute respiratory infection runs into the most common noncommunicable epidemic-covid- and cardiovascular diseases harnessing real-world data for regulatory use and applying innovative applications key: cord- - ggxzxu authors: husebo, bettina sandgathe; allore, heather; achterberg, wilco; angeles, renira corinne; ballard, clive; bruvik, frøydis kristine; fæø, stein erik; gedde, marie hidle; hillestad, eirin; jacobsen, frode fadnes; kirkevold, Øyvind; kjerstad, egil; kjome, reidun lisbeth skeide; mannseth, janne; naik, mala; nouchi, rui; puaschitz, nathalie; samdal, rune; tranvåg, oscar; tzoulis, charalampos; vahia, ipsit vihang; vislapuu, maarja; berge, line iden title: live@home.path—innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial date: - - journal: trials doi: . /s - - -y sha: doc_id: cord_uid: ggxzxu background: the global health challenge of dementia is exceptional in size, cost and impact. it is the only top ten cause of death that cannot be prevented, cured or substantially slowed, leaving disease management, caregiver support and service innovation as the main targets for reduction of disease burden. institutionalization of persons with dementia is common in western countries, despite patients preferring to live longer at home, supported by caregivers. such complex health challenges warrant multicomponent interventions thoroughly implemented in daily clinical practice. this article describes the rationale, development, feasibility testing and implementation process of the live@home.path trial. methods: the live@home.path trial is a -year, multicenter, mixed-method, stepped-wedge randomized controlled trial, aiming to include dyads of home-dwelling people with dementia and their caregivers, recruited from municipalities in norway. the stepped-wedge randomization implies that all dyads receive the intervention, but the timing is determined by randomization. the control group constitutes the dyads waiting for the intervention. the multicomponent intervention was developed in collaboration with user-representatives, researchers and stakeholders to meet the requirements from the national dementia plan . during the -month intervention period, the participants will be allocated to a municipal coordinator, the core feature of the intervention, responsible for regular contact with the dyads to facilitate l: learning, i: innovation, v: volunteering and e: empowerment (live). the primary outcome is resource utilization. this is measured by the resource utilization in dementia (rud) instrument and the relative stress scale (rss), reflecting that resource utilization is more than the actual time required for caring but also how burdensome the task is experienced by the caregiver. discussion: we expect the implementation of live to lead to a pathway for dementia treatment and care which is cost-effective, compared to treatment as usual, and will support high-quality independent living, at home. trial registration: clinicaltrials.gov: nct . registered on march . the world's population is rapidly aging as a result of fewer births and declining mortality rates [ ] . the global health challenge of dementia is exceptional in size, cost and impact [ ] . according to the world health organization, the number of people living with dementia is estimated to be million worldwide, expected to almost triple by [ ] . despite most people, also from a caregiver perspective, preferring to live longer at home, and to die there, if possible [ , ] , about , of the estimated , - , persons with dementia (pwds) in norway reside in nursing homes [ ] . the urbanization of our societies, in particular younger persons moving toward central areas and leaving their older relatives behind, underlines the need for cost-effective service collaboration to provide adequate treatment and care for the aging home-dwelling population. among the top ten causes of death globally, dementia is the only one that cannot be prevented, cured or substantially slowed [ ] , leaving disease management, caregiver support and service innovation as the top priority for health policy-makers in the reduction of disease burden. due to expected positive interactions within the family, interventions supporting them as caregivers not only potentially lessen the caregivers' burden [ ] , but could also be beneficial for the pwd (e.g. reducing neuropsychiatric symptoms and delaying nursing home admission) [ , ] . as such, interventions supporting caregivers hold the potential for better overall resource allocation and utilization [ ] . caring for a pwd comes at a high cost, both individually and at societal level. caregivers to pwds have lower perceived health and higher rates of mortality relative to their noncaregiver counterparts [ ] . the effect of practical assistance and psychoeducational programs have been evaluated, but most single initiatives have fallen short in reducing the caregivers' burden [ ] . the maximizing independence (mind) at home study undertaken in baltimore, usa, during - included approximately home-dwelling persons with cognitive impairment or dementia in a parallel randomized multicomponent trial [ , ] . this study showed that months of care coordination through individualized care planning, implementation of a care plan, monitoring and reassessment had beneficial effects on the time to transition from home, number of dementiarelated unmet needs, quality of life (qol) and, importantly, a potentially clinically relevant reduction in selfreported number of hours spent on caregiving tasks, as a measure of caregiver burden [ , ] . developing this model further, the mind at home-plus study included an additional persons to evaluate the effect on longterm care placement, hospitalization and health-care expenditures of a -month homecare coordination program for pwd [ ] . the mind at home-streamlined trial is now refining the intervention to investigate its impact on time to long-term care placement, needs, burdens and qol in pwds and their caregivers, as well as cost utilization [ ] . results of the latter study are highly anticipated due to the potential for effective system-level approaches to dementia care [ ] . yet, due to fairly large regional and cultural differences in care organization, there is a need for implementation studies in other countries to explore the generalizability of the program. a multicomponent intervention is not merely a discrete package of separate components, but a process of changing what complex systems do [ ] . intervening within a complex system involves disrupting prior ways of working while introducing new ones [ ] . the degree of complexity can be understood as a relative construct, defined by the number of components, diversity of the intended outcome, number of targeted organizational levels and level of skill required to deliver the intervention [ ] , while additionally considering the interplay between context, setting and the implementation process [ ] . in the cosmos trial, a randomized implementation hybrid trial carried out in norwegian nursing homes during - , our group successfully developed, implemented and effect evaluated a multicomponent intervention addressing communication, systematic assessment and treatment of pain, medication review, organization of activities and safety [ ] . overall, the intervention resulted in improved qol and activities of daily living (adl), in addition to a decrease in neuropsychiatric symptoms such as agitation and depression as well as a reduction in the number of medications used among nursing home residents [ ] [ ] [ ] [ ] [ ] . to provide cost-effective care while securing the needs of pwds and caregivers represents a complex health challenge warranting multicomponent interventions implemented in daily clinical practice. aiming at systemlevel change, such interventions require stakeholder involvement as well as collaboration within and between different levels of primary and specialist health-care services, nongovernmental institutions, users and researchers, addressing the need for appropriate and coordinated cross-sector action. the live@home.path trial aims to develop, adapt, implement and effect-evaluate a multicomponent intervention for home-dwelling dyads of pwds and their caregivers, aiding them to stay safer, longer and more independently at home with cost-effectiveness. in this study, caregivers are defined as family or close friends, equaling informal caregivers. live@home.path is an acronym referring to each component of the complex intervention: learning, innovation, volunteer support and empowerment-at home pathway. the primary outcome is resource utilization. this is measured by the resource utilization in dementia (rud) instrument and the relative stress scale (rss), reflecting that resource utilization is more than the actual time required for caregiving tasks, but also how burdensome the task is experienced by the caregiver. importantly, the caregiver burden is individual, and may be related to economic hardship, anxiety, depression, hopelessness, impaired qol or lack of sleep and time for recreation. this individual perspective underlines the significance of user involvement, reflected in the trial's slogan: what matters to you? secondary outcomes include neuropsychiatric symptoms, number of adverse events, use of assistive technology, involvement of volunteers, qol and clinical global impression of change for the pwd as well as caregivers' depression, qol and work performance. the live intervention will reduce time and resources that caregivers spend in organizing and supporting pwds' daily activities, thereby reducing the caregiver burden. the live@home.path trial is a -year, multicenter, mixed-method, stepped-wedge randomized controlled trial (rct). we aim to recruit dyads of home-dwelling pwds and their caregivers from the municipalities of bergen, baerum and kristiansand. based on experiences with two pre-projects-research council of norway sponsor code (uib) and (haraldsplass deaconess hospital)-the intervention was developed in collaboration with userrepresentatives, stakeholders and scientific partners from the scientific advisory board. to meet the requirements from the dementia plan by the ministry of health and care services [ ] , we identified the "big issues" expected to facilitate support for home-dwelling pwds and their caregivers. as such, we combined and adapted existing knowledge rather than designing new components, contributing to service innovation in the health-care systems. the process was tailored to meet the standards of "development-evaluation-implementation", an internationally agreed approach for complex interventions launched by the uk medical research council [ ] . at the start of the -month intervention period, the dyads will be allocated to a municipal coordinator, offering regular contact to assist in finding a pathway throughout the administrative trajectory of dementia care. the coordinator should hold a bachelor degree in health-related science (e.g. nursing, ergo or physiotherapy), and will make a minimum of two home visits, one immediately after the intervention start and the second after approximately months. supplementary visits will be offered if needed, in addition to monthly telephone calls. during the intervention, the coordinator will introduce the dyads to the different stages of the live intervention: learning, innovation, volunteer support and empowerment (table , fig. ). all components will be carefully adapted to local conditions. learning a fruitful learning process is characterized by relevance, timing, confidentiality and reflection as well as fulfilment of expectations regarding content. the dementia plan [ ] underlines increased knowledge at all societal levels as crucial for improvements in dementia care. a meta-analysis on the effectiveness of educational interventions supporting caregivers of communitydwelling pwds found a moderate impact on the caregiver burden, a small effect on depression, but no effect on transition to long-term care [ ] . a norwegian multicenter randomized controlled trial found no reduction in depressive symptoms for pwds and caregivers after a -month psychosocial support program including formal education seminars [ ] . yet coping had a positive impact on the caregiver burden in the latter study, possibly reflecting improved understanding of the caregiver situation [ ] . in practice in the live@home.path: the coordinator will encourage and facilitate that both the pwd and the caregiver participate in local educational programs arranged by the municipality or the specialist health services several times yearly. as an example, the nationally established educational program for relatives of pwds is developed by the norwegian advisory unit on ageing and health [ ] , and implemented for use in bergen, baerum and kristiansand. innovation innovation is understood as the application of better and more original solutions to meet new requirements, unarticulated needs or existing market needs, or employing established solutions in new areas, both technological, such as information and communication technology (ict), and organizational. crucially, the process will result in more effective products, processes, services, technologies or business models being made available for all, including markets, government and society [ ] . as such, the live@home.path can be viewed as a service innovation, aiming at the development of a clinical pathway for dementia care. ict approaches in elderly care are broadly categorized as technical aids, cognitive intervention devices, and sensor and assistive living systems [ ] . ict in dementia care holds potential for optimizing safety at home, reducing caregiver burden and, although the findings are not conclusive [ ] , possibly also improving cost-effectiveness. yet we have limited knowledge about which type of devices are used, regarded as useful and requested by caregivers and pwds at different stages of dementia [ ] . most important, this field requires a careful, individual risk-benefit assessment, as ict might negatively impact autonomy and privacy, and provide a false sense of safety. in practice in the live@home.path: the coordinator will assess and evaluate the usefulness of ict solutions already in use for pwds and caregivers and inform about additional relevant welfare technology available in the municipality. the participants will receive information about a newly launched online communication platform tailored to meet the needs of families organizing dementia care (jodacare©) [ ] , and be informed about a web page with scheduled activities of relevance (fris-kus©) [ ] . in bergen, the participants will be invited to test the prototype alight©, an application for tablets providing a "digital memory book" developed by soundio as and nks olaviken gerontopsychiatric hospital [ ] . additionally, up to ten participants in bergen will be invited to test a prototype of the adapted communication platform in collaboration with the western norway university of applied sciences. underlining the aspects of service innovation, all data will be collected on tablets owned by the project group via the software surveyjs [ ] . the live@home.path trial was selected as a pilot for the development and evaluation of this software, providing secure data transfer and storage on the safe server at the university of bergen for research project with sensitive data. after approval from the principal investigator, researchers affiliated with the project will be given access to the server, avoiding export of data and maintaining high levels of security [ ] . volunteer support volunteer support is understood as any activities that involves someone spending time, unpaid and of one's own will, doing something that aims to benefit someone else outside their own families and households [ ] . being important suppliers of unpaid support, it is estimated that volunteers contributed , full-time equivalents (ftes) in norway in [ ] . however, the majority are engaged in sports and culture, and representation in the elderly care sector is sparse [ ] . volunteering among older adults reduces their depressive symptoms, improves self-reported health and functional performance, and increases survival [ , ] . the volunteers additionally report better health through their own engagement [ , ] . volunteerism has contributed to the development of the norwegian welfare system through identifying and providing solutions to societal challenges [ ] , being formally integrated into core strategic plans in the health-care sector and being launched as a prioritized political strategy in elderly and dementia care in norway [ ] . yet we have sparse knowledge about volunteer support schemes for homedwelling pwds. to provide better services, understanding of the dynamics, motivations and interactions in volunteerism in dementia care is required. in practice in the live@home.path: the coordinator will investigate pwd and caregiver attitudes toward volunteer support, and inform about volunteer services. if this is of interest, the coordinator will contact local volunteer coordinators for nonprofit organizations (the red cross [ ] and the norwegian association for public health [ ] ), aiming at the best possible match of volunteers based on assessment of preferences and wishes. empowerment empowerment in dementia care can be defined as "a confidence building process whereby pwd are respected, have a voice and are heard, are involved in making decisions about their lives and have the opportunity to create change through access to appropriate resources" [ ] . the process of advanced care planning (acp) can increase empowerment for pwds and their caregivers [ , ] , underlined by the norwegian policy guidance by the directorate of health on diagnosis, treatment and care for pwds [ ] . pwds do not necessarily die from dementia, they die with it, and the life expectancy after onset of symptoms ranges from to years, depending on age and the presence of comorbidities [ ] . the continuing process of communication should be initiated as early as possible in collaboration with the general practitioner as a comprehensive medical examination including revision of medications, enabling the pwd to clarify individual values and wishes for domestic and institutionalized treatment and care (i.e. "what matters to you?"). in practice in the live@home.path: the coordinator will schedule a minimum of one appointment at the general practitioner's office for empowering acp, including the issues of formal next of kin and guardianship. in addition, a systematic medication review will be undertaken to ensure use of medications in line with diagnoses and symptoms, utilizing recommended guidelines [ ] . to evaluate the feasibility and the implementation strategy of the coordinators of the live intervention, a feasibility study was conducted during - . sixteen dyads in bergen were assigned a coordinator for months, participating in a minimum of two home visits and providing monthly follow up by telephone. one dyad dropped out after a few weeks of participation due to permanent placement in a nursing home, leaving dyads followed by coordinators for assessment. qualitative individual and focus group interviews utilizing a hermeneutic approach were performed with six dyads, three caregivers and the two coordinators as well as the coordinators' leader, exploring the usefulness of the coordinator function. this process revealed that the core feature of the coordinator was to support the caregivers in finding, applying and organizing support, and to provide emotional care, support and guidance. the objective of empowering the pwd in the decision-making processes was nonetheless particularly difficult to achieve. this finding was further incorporated into the live intervention for the stepped-wedge rct, with increased focus on the acp process and follow up of the gp [ ] . implementation research is defined as the scientific investigation concerning the act of carrying an intervention into effect in the real-world setting [ , ] . even a superbly designed intervention will fail to change practice if the process of implementation is futile. in the live@home.path trial, the implementation can be viewed as a two-stage process: first, from the research team to the coordinators; and, second, from the coordinators to the dyads. the first part encompasses all activities arranged by the research team empowering the coordinators to standardize the implementation of the intervention, such as seminars, development of written material and follow-up of coordinators during the intervention period. six months prior to the intervention start, kick-off workshops for all involved collaborators in the municipalities, including coordinators and affiliated specialized health services, will be arranged at all study sites, facilitating enthusiasm, collaboration and recruitment of participants. two weeks before the intervention start, a -day implementation seminar for the coordinators will be delivered by the research team at all study sites, training the coordinators through lectures, roleplay and discussions (see additional file ). halfway through the -month intervention period, a -day midway evaluation workshop for the coordinators will be arranged, allowing for discussion of obstacles and pitfalls, which acts as a source for facilitating a more effective and standardized implementation. as a part of the intervention, the research team will contact each coordinator by telephone every days to keep track of the process, discuss potential challenges and follow-up use of the checklist for implementation of the intervention. this ten-page pocket manual will contain a simplified howto-do description of the intervention components. it will be filled out for each dyad by the coordinator, registering time use and whether each of the distinct live components has been addressed during the intervention period. additionally, a -page tutorial will be developed as a comprehensible introduction to the rationale, method and practical aspects of the conduction of the trial, aimed for an audience not skilled in the research method. the second part of the implementation process encompasses the coordinator-dyad relationship. the coordinators are obliged to arrange a minimum of two home visits during the intervention period, and provide monthly contact by telephone. the checklist for implementation of the intervention will be used at every contact, and collected by the research team at the end of the intervention, providing documentation for the implementation process. in addition to the midway evaluation, a live conference will be organized for all coordinators at the end of the third intervention period, collecting data on their experiences of the suitability of the single components and the implementation process. additionally, at data collection after the intervention period, the participants will be asked if and to what extent they were offered the live components, and how often they were contacted by their coordinator. as such, if the live intervention fails to prove an effect on resource utilization, it will be possible to examine whether this is a result of the live components not being tailored to produce such an effect (i.e. that our main hypothesis was wrong) or whether it was caused by a lack of proper implementation. evaluation of the implementation process will further be investigated by conducting qualitative interviews with the coordinators as part of the mixed-method design. the required sample size was calculated to detect a difference of h/week for the primary outcome rud. based on the literature, we assumed that the mean number of hours of informal care is h/week with a standard deviation (sd) of h/week [ ] . with % power and a significance level of %, the required sample size was estimated to be dyads. to allow for % loss to follow-up, a total of dyads, equaling per municipality, must be included. participants will be recruited from memory clinics at local hospitals, from municipal memory teams and after advertisements in general media such as newspapers, radio and tv in bergen, baerum and kristiansand. bergen is the second largest municipality of norway with approximately , inhabitants in , baerum is ranked the fifth largest with , inhabitants, while the , inhabitants of kristiansand constitute norway's sixth largest municipality [ ] . pwds are eligible for inclusion if they: are aged ≥ years; are home-dwelling; have a minimum h/week regular face-to-face contact with the caregiver; are diagnosed with dementia according to standardized protocol [ ] ; have mini-mental state examination (mmse) score of - ; have a functional assessment staging test (fast) score of - ; and provide written informed consent. exclusion criteria are: participation in another ongoing intervention trial; or expected survival < weeks. pwds are eligible for inclusion regardless of etiology of the dementia and presence of other disorders. caregivers are eligible for inclusion if they have a minimum of h/week regular face-to-face contact with the pmd and provide written informed consent. as such, both the pwd and the caregiver will be included in the trial, representing a dyad. the mixed-method, stepped-wedge randomized control design data from all dyads will be assessed every months from baseline to the end of study period after months, death or permanent residency in a nursing home-in total, five waves of data collection. the stepped-wedge randomized control design [ ] implies that all participants will receive the -month intervention program during the study period, for which the timing of the intervention is determined by the randomization (fig. ) . the control group constitutes the dyads waiting for the intervention at a given time during the study; this group will have access to health care and receive treatment as usual. criteria for discontinuing the intervention or participation are requested from participants to withdraw from the trial. the trial's user-oriented approach, aiming at minimizing the participant burden associated with follow-up visits, in addition to flexibility in scheduling of the visits are sought to promote retention and prevent loss to follow-up over the trial. no distinct adverse events are expected before the start of the trial or during the trial, while possible adverse events related to the change in prescribed medication during the general practitioner's medication review might occur. if so, they will be reported by the coordinators to the researchers, either immediately or at their regular follow-up every weeks (physical meeting, by phone or by e-mail), in addition to feedback from the coordinator to the general practitioner. a statistician will randomly allocate the order of the intervention using block randomization; the dyads are randomized in clusters within each geographical location. the random sequence will be generated using a computerized random number generator undertaken for all three municipalities after the inclusion and baseline assessments are completed for all participants. research assistants, researchers conducting the analyses and other study personal conducting data collection will be blind to the randomization order and to the implementation process of the intervention. participants will not be informed of the intervention and implementation strategy to secure blinding until they are allocated to their coordinator during the intervention period. from this point of time, they become unblinded. given the practice change of the intervention, the municipality homecare services will be aware when their cluster enters the intervention period. when developing a pathway for dementia care, incorporating experiences and perspectives from the pwds and their caregivers is fundamental. in line with the involve framework [ ], this trial is developed through user involvement from the conception of the idea, via design through the implementation phase. at the structural level, user involvement is secured via collaboration with the head of research at the norwegian health associations [ ] , participating in the steering committee, and locally grounded by dementia coordinators in the municipalities. at the individual level, the centre for elderly and nursing home studies (sefas), responsible for conducting the trial, employs a user-representative as a co-researcher in a % position, who participates in the study's advisory board and working group. the mixed-method design [ ] encompasses the integration of data from quantitative assessment of validated outcomes with material from qualitative interviews and participant observation. utilizing an exploratory hermeneutic design [ ] , in-depth and focus group interviews with pwds (n = ), caregivers (n = ), municipality health-care staff (n = ), general practitioners (n = ), volunteers (n = ) and volunteer coordinators (n = ) will be conducted. to evaluate the acceptability and feasibility of the communication platform, interviews with caregivers and care staff will be made, as well as real-life observations form use among pwds and caregivers. table presents the primary and secondary outcomes according to domain, specific measurement, metric, method of aggregation and time points. the primary outcome of the live@home.path trial is formal and informal resource utilization, measured by the rud instrument [ , ] and the rss [ ] ( table ). as such, we consider overall resource utilization as more than the time required to care for the pwd; it also encompasses how burdensome the task is experienced by the caregiver. the informal care time use is measured in hours/ month [ , ] , in addition to numbers of contacts with the health-care system and use of medications. the rud is a standardized and widely used instrument assessing dementia care, proven useful across different care systems and countries and in both clinical trials and observational studies [ , ] . caregivers stress will be assessed by the rss, a self-report instrument covering three dimensions of "emotional distress", "social distress" and "negative feelings". it is regarded as a useful instrument to stratify careers according to the risk of psychiatric morbidity [ , ] . the secondary outcomes presented in table include measures of qol, psychiatric symptom load, adl, comorbidity and pain as well as measure of goal achievements. the qol for both the pwd and the caregiver will be measured by self-report using the quality of life in alzheimer's disease scale (qol-ad) [ ] and the generic quality of life measure eq- d- l [ ] , including the eq- d-vas scale [ ] . additionally, qol for the pwd will be assessed by proxy by the caregiver with the qol-ad [ ] . psychiatric symptoms for the pwd will be proxy rated by the caregiver using the neuropsychiatric inventory questionnaire (npi- ) [ ] , the cohen-mansfield agitation inventory (cmai) [ , ] and the cornell scale for depression in dementia (csdd) [ ] , fig. a stepped-wedge randomized control design. the randomization in time takes place at month . first group (red) is in the intervention period from month to , second group (yellow) from month to and third group (green) from month to . implementation seminars will be held at months , and , and midway evaluation at months , and . data will be collected at baseline (month ), after the first intervention period (month - ), after the second intervention period (month - ), after the third intervention period (month [ ] [ ] and at the end of the study at months. b schedule of enrollment, interventions and assessments over the study period mean mean difference in score over the -month intervention period summarized for the three while caregiver psychiatric symptoms will be selfreported using the geriatric depression scale (gds) [ ] in addition to the rss [ ] . data on adl for the pwd will be proxy rated by the caregiver utilizing instrumental (i-adl) and personal (p-adl) measures [ ] . data on pain will be obtained by self-report from the pwd using the mobid- pain scale [ ] [ ] [ ] [ ] [ ] and the level of comorbidity will be evaluated by the interviewer according to the general medical health rating scale (gmrh) [ ] . the clinical global impression of change scale (cgic) will be assessed after the intervention to quantify and track patient progress and treatment response [ ] . in addition to the instruments presented in table , other outcome measures include the number of adverse events (falls, disappearances outdoors, fire hazard), use of assistive technology (number of technical aids, cognitive intervention devices and assisted living systems), involvement of volunteers (number of participants with contact with a volunteer, number of hours spent with a volunteer), number of medications used (both regular and on demand) and participation in educational programs for the pwd and the caregiver. these outcome measures will be described as the mean change in sum of events (number devices, hours, medications, educational programs) over the intervention period compared to controls (as outlined in table ). prior to inclusion and baseline data collection, a -day seminar will be arranged for the study personal to secure training in the use of tablets and scoring of relevant psychometric scales. a study manual has been developed to guide data collectors during their visits to secure standardized reporting. close to h/day, telephone and mail support will be offered by the research team during times of data collection. researchers and municipal study personal will collect data at baseline as well as , , and -month follow-up. the municipalities will receive nok per enrolled dyad to compensate for extra administrative work. at baseline, demographic data such as year of birth, gender, marital status, housing characteristics, education and employment will be collected, as well as data on the dementia syndrome, including the current score on the mini-mental state examination, norwegian version (mmse-nr ) [ , ] , mean difference in score over the -month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groups a mean difference in score over the follow-up period in -month intervals stratified by time from end of intervention b all assessment will be made by research personal or affiliated staff in the municipalities during home visits with the person with disability (pwd) and the caregiver a intervention groups: group (red), t -t ; group (yellow), t -t ; group (green), t -t . control groups: (t -t + t -t ) (see fig. a ) b group (red): three -month periods, t -t , t -t and t -t . group (yellow): two -month periods, t -t and t -t . group (green): one -month period, t -t (see fig. a ) functional assessment staging test (fast) [ ] and the informant questionnaire on cognitive decline in the elderly (iqcode) [ , ] . the mmse-nr [ ] will be assessed every months during the trial. intention-to-treat analyses will be performed accounting for municipality as a random effect in mixed-effect models and the generalized estimating equation (gee) with nonlinear effect comparing the intervention groups to controls. repeated observations within persons will be accounted for with a correlation matrix. all secondary outcomes will be adjusted for multiple comparisons using the hochberg method [ ] . given the potentially informative censoring due to dropout, institutionalization and death, we will jointly model the primary outcome and attrition through a shared person-specific random intercept. missing data will be handled using multiple imputations by chained equations (mice). the study was approved in may by the regional committee for medical and health research ethics, north norway ( / ) and west norway ( / ) (the pilot), and registered at clinicaltrials.gov (nct ). assessment and utilization of personal data from the dyads as well as from volunteers and volunteer coordinators from nonprofit organizations are approved by the norwegian centre for research data (nsd) (ref. ). after verbal and written information, spoken and written informed consent was obtained in direct conversation with the caregiver and the pwd, if capable of providing consent for participation. if not, the next of kin or a legal advocate provided consent based on their determination on whether the pwd, when they were able, would have agreed to participate in the trial. compared to care as usual, we expect the live@home.-path trial to innovate the clinical pathway in dementia care, facilitating cost-effective, feasible and independent living at home through learning, innovation, volunteering and empowerment. participation in research is based on affirmative, unambiguous, informed and specific consent [ ] . persons with cognitive impairment will often not be able to provide such a comprehensive consent or understand the scope and consequences of data assessment. local legislation for obtaining ethical permission in studies varies substantially between european countries [ ] . in norway, the next of kin or a legal advocate can provide consent based on their determination of whether the person, when they were able, would have agreed to participate in the trial [ ] . these principles for obtaining informed consent were applied in the live@home.path trial. from , the european union-wide law on data protection, the general data protection regulation (gdpr), represents a significant step toward protection of participants in research [ ] . in particular, article protects pwds and their relatives from being coerced to consent without awareness of how their data will be used [ , ] . when assessing sensitive data such as mental health, article requires a data protection impact assessment (dpia), a formal process systematically analyzing, identifying and minimizing the data protection risks of a project. we developed a dpia (ephorte uib: / ) for the live@home.path trial in collaboration with the data protection official at the university of bergen, encouraging us to again evaluate which data to assess, as well as focus on safe data management. nonetheless, we anticipate the participation in the live@home.path trial to be less burdensome relative to, for example, rcts on effect of medications, due to the user-oriented approach emphasizing the investigation of the perspective "what matters to you?" stakeholders and research funders increasingly require patient and public involvement (ppi) at all stages of research from design, implementation and dissemination of results, shifting focus from research "about" or "for" to research "with" or "by" someone [ , ] . our userrepresentative has provided feedback on a close to weekly basis through participation in the working group and advisory board of the trial. a related principle, responsible research and innovation (rri), is defined as a transparent, interactive process making societal actors and innovators mutually responsive to each other, and encouraging them to set up a critical perspective when evaluating the innovation and marketability of products [ , ] . taken together, these components constitute a framework for sustainable ethic innovation in dementia research (fig. ) , a model that easily can be applied when designing and conducting research on other vulnerable patient groups. a stepped-wedge randomized controlled trial design is recommended for evaluation of a multicomponent intervention in health-care services as it provides a number of practical and scientific benefits compared to an ordinary rct [ ] . it is increasingly used in effectiveness studies in the geriatric field [ , ] . most importantly, the design allows for providing the intervention to all participants, overcoming ethical and logistical challenges arising from withholding the intervention. this design is, however, more vulnerable to temporal external changes, as more participants are exposed to the intervention toward the end of the study than in earlier stages. if the live intervention fails to prove an effect on resource utilization, we will examine whether this is due to a lack of proper implementation. thus, if the implementation process is satisfactory, it may suggest that the live components were not tailored to be sufficiently cost-effective if no effects on primary outcome measures are found. an alternative interpretation is that the intervention may not be cost-effective even if primary outcomes change significantly, as resource use by the intervention is more time consuming and/or expensive than the alternative. some challenges have emerged during the start of the trial. first, it is demanding to include the estimated number of participants, and, additionally, to keep the number of dropouts low due to the progression of the disease. we should have established closer collaborations with the geriatric specialist health-care services, as we experienced that patients recruited from geriatric outpatient clinics were in the most optimal disease stage for this trial. to increase recruitment, we prolonged the inclusion period to december and expanded the inclusion criteria to age ≥ years and mmse range - , while the sefas researchers, journalist and co-researcher with user experience continuously work on positive media coverage. second, data collection from home-dwelling persons in three distinct municipalities is resource and logistically demanding. third, being selected as a pilot for the data collection software has been challenging, as the file format initially generated handled missing data in a way that was not compatible with our statistical programs. finally, the participants have so far been recruited in various ways, from home-care services in the municipality and memory clinics at hospitals, to self-referrals after advertisements in the general media. this implies that the dyads included in our trial represent a heterogeneic group of home-dwelling people with dementia. in conclusion, we expect the implementation of live to lead to a pathway for dementia treatment and care that is cost-effective, feasible and supports independent living, at home. a total of dyads had been screened for participation from may , of which were included in the trial. by january , when recruitment ended, dyads had dropped out. mainly due to a more rapid inclusion process than anticipated, this protocol was submitted after the end of the recruitment period but in due time before the last visit for data collection. at the time of resubmission in may , the covid- pandemic had profoundly impacted the norwegian healthcare system, including services in the municipal sector, challenging the implementation of the intervention in group . newsletters with status, possible modifications and upcoming events will be sent by e-mail to the site leaders and coordinators every - months. final protocol version number will be prepared by june . plan for dissemination apart from the usual academic publications from the live trial in terms of papers and conference presentations, the authors will ensure maximum publicity through the collaborating centers' popular blogs, media work and scientific network. the latter includes most of the world's leading experts on pain, bpsd, palliative care, and wearable and sensing technology for people with dementia. we will exploit the technology network, cost-action td group, and conduct research visits to three of the overseas associated centers of excellence (harvard university, yale university and tohoku university) that are part of our management group; host at least four visits by overseas members of the network; host two major -day international workshops (years and ); and host nine seminars for formal caregivers in homecare services. the live website will also provide a forum for outreach for the public, including research participants, continuously updated with results from the trial. researchers will attend two international conferences per year, while we expect each researcher to attend a conference every other year to achieve coverage and exposure of the trial. conception or design of the work: bsh is the principal investigator of the trial, lib is the site lead for the trial. all coauthors have contributed substantially to the conception of the idea and at the different stages of development of the trial and/or toward the different components of the intervention and/or practical conduction of the trial. drafting the article: bsh and lib drafted the manuscript. critical revision of the article: all coauthors contributed significantly to the critical revision of the drafts, improving the method and its content. final approval of the version to be published: all coauthors approved the final submitted version of the manuscript. the international committee of medical journal editors criteria for authorship will be applied to evaluate whether contributors fulfill the criteria for authorship on future publications with data from the trial. no professional writers will be involved in manuscripts with data from the trial. the trial is funded by the research council of norway (www.forskningsradet. no) (sponsor's protocol code ), the research council of norway (sponsor's protocol code-pre-project (uib) and (haraldsplass deaconess hospital)), including two phd positions (mv and mhg) and three postdoctoral positions (rca, np and lib). the dignity centre funds one additional phd position (eh). the sponsors will have no role in planning the design, collection, management, analysis, interpretation of data and writing of reports and will have no decision on where to submit the report for publication. data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. the public will not receive full access to the complete protocol, dataset and statistical procedures; however, this information can be made available to other researchers upon request. the study was approved in may by the regional committee for medical and health research ethics, north 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public deliberations on how technology and humans may support independent living for older adults nurse-led medicines' monitoring for patients with dementia in care homes: a pragmatic cohort stepped wedge cluster randomised trial alleviating staff stress in care homes for people with dementia: protocol for stepped-wedge cluster randomised trial to evaluate a web-based mindfulness-stress reduction course publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the live@home.path trial is funded by the research council of norway with two phd grants and three postdoctorate grants. the centre for elderly and nursing home medicine at the university of bergen responsible for conducting the trial is funded by gc rieber foundations and the norwegian government. the authors acknowledge valuable support from the collaborating municipalities and their main contact person anne marie hanson (baerum), beate sørensen (kristiansand) and anita krokeide (bergen), as well as from the dignity centre, the dam foundation western norway university of applied sciences and the norwegian national advisory unit on women's health, oslo university hospital. supplementary information accompanies this paper at https://doi.org/ . /s - - -y.additional file . implementation seminar for the live@home.path trial. key: cord- -x gd kq authors: kelly, frank j.; mudway, ian s.; fussell, julia c. title: air pollution and asthma: critical targets for effective action date: - - journal: pulm ther doi: . /s - - - sha: doc_id: cord_uid: x gd kq evidence to advocate for cleaner air for people with asthma is not in short supply. we know that air pollution is associated with the development and worsening of the condition and that mitigating interventions can improve respiratory outcomes. we have clear targets, particularly traffic emissions, especially in urban areas, and plenty of potentially effective actions. road traffic must be reduced, and what remains should be cleaner and greener. urban green spaces, safe cycle networks and wider pavements will promote active travel and leisure time exercise. healthcare professionals must ensure people are aware of their air quality, its impact on asthma and the appropriate behaviour to safeguard health. what remains are realistic policies and effective measures, based on the correct scientific evidence, to be taken forth with political courage and investment so that air pollution no longer contributes to the development or worsening of respiratory ill health. we know that air pollution is associated with the development and worsening of asthma and that improving air quality can result in respiratory health gains. the challenge associated with achieving sustained reductions in air pollutants to reduce new-onset asthma and prevent worsening symptoms in those already afflicted should not be considered an intractable one. we have clear targets and a wealth of opportunities to effectively act and make progress. in this review, we discuss a broad array of interventions, targeted to multiple sectors of society, with the aim to bring multiple public health benefits, in addition to air quality improvements. asthma is a common and chronic condition of the lung in which inflammation causes the bronchi to swell and narrow the airways, leading to episodic periods of wheezing, shortness of breath, cough and chest tightness. it affects around million people worldwide [ ] . incidence and prevalence are higher in children, however morbidity and mortality are higher in adults [ ] . asthma tends to be a disease of more developed economies where there is some evidence that prevalence may have peaked [ ] . in contrast, rates are increasing in low-and middle-income countries where outcomes are much worst [ , ] . superimposed upon day-to-day symptoms, sufferers experience life-threatening exacerbations lasting from days to weeks, which are caused by a variety of stressors, including respiratory viral infections, allergen exposure and air pollution. there is now consistent evidence that exposure to traffic-related air pollution (trap; particularly nitrogen dioxide [no ]) is associated with an increased risk of developing asthma across the entire life course, and evidence is accumulating for a link between poor indoor air quality and new cases [ , ] . a recent global (incorporating countries and major cities) estimate of the burden of paediatric asthma incidence attributable to ambient no at a spatial resolution fine enough to resolve intra-urban and near-roadway exposure gradients reported that each year million new paediatric asthma cases could be attributable to no pollution; % of these in urban centres (table ) [ ] . the work also estimated that about % of children lived, and % of new asthma cases attributable to no occurred, in areas with annual average no concentrations lower than the world health organisation's annual air quality guideline of lg/m . whilst there is no known cure for asthma, pharmacological intervention significantly improves symptoms [ , ] . unfortunately, however, despite international guidelines, treatment compliance rates ([ %) required to maintain disease control is often poor, even in countries where treatment is readily accessible [ , ] . reducing the onset of asthma and safely controlling symptoms through air pollution mitigation strategies, discussed herein, should therefore be regarded a significant component of the overall armamentarium against this debilitating respiratory condition. the studies selected for inclusion in this review were collected through a search of the pubmed database and grey literature using the following keywords: 'asthma' and 'air pollution' or 'traffic' or 'indoor air' or 'particulate matter (pm)' or 'no ' or 'oxides of nitrogen (no x )' or 'diesel' and 'mitigating' or 'interventions' or 'policy' or 'reducing' or 'action' or 'public awareness'. the information included in this review has been chosen to deliver a broad discussion of interventions, targeted to multiple sectors of society, to reduce the burden of air pollution on the prevalence and severity of asthma. this article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. data from many parts of the world strongly suggest that policies designed to reduce air pollution can improve respiratory outcomes. in california, reductions in pm . (pm with a diameter \ . lm) and no between and reduced the risk of incident asthma in children by % (fig. ) [ ] . in a swiss cohort of adults, a decline in pm (pm with a diameter \ lm) concentrations from to was associated with a % decrease in the annual rate of decline in forced expiratory volume in s [ ] . a follow-up study found that for every , persons in the community, a further decline in pm from to was associated with fewer people with wheeze or shortness of breath [ ] . in japan, legislation was passed in to limit transportation-related emissions. by , decreases in pm . and no were linked to a lower ( . - . %) prevalence of paediatric asthma [ ] . benefits have also been observed following local air quality interventions associated with factory closures and hosting of olympic games. hospital admissions for childhood asthma fell by half, in association with a significant reduction in pm . , because of a -month closure of a steel mill in the utah valley [ ] . a -day ''alternative transportation strategy'' implemented by the city of atlanta in the summer of brought about a % decrease in peak morning traffic; within weeks of this decrease, there was a % reduction in children seeking medical care and a % decrease in hospitalisations for asthma [ ] . in preparation for the beijing olympics, the chinese government enacted factory emission and travel restrictions that resulted in pollutant concentrations decreasing by up to % [ ] . within months, these reductions were linked to an improvement in lung function among both healthy adults and those with asthma [ ] as well as % fewer asthma-related physician visits [ ] . benefits of improving indoor air quality have also been documented. installing less polluting heating appliances (heat pump, wood pellet burner, flued gas) in homes of children with asthma in new zealand reduced symptoms, days off school, healthcare use and visits to a pharmacist [ ] . australian schools randomly allocated either to retain unflued gas heaters or have replacement flued gas/electric heaters installed reported a significant reduction in breathing difficulties, chest tightness and asthma attacks in the intervention group [ ] . the substantial challenges associated with achieving the sustained reductions in air pollutants necessary to reduce new-onset asthma and to prevent a worsening of symptoms in those already afflicted reflect not only the insidious nature of this environmental insult, but also the wealth and complexity of issues entwined with sub-optimal air quality. europe's car fleets have been transformed to being powered by diesel (emitting more pm and no x than their petrol or hybrid counterparts) [ ] . the powering of light and heavy goods vehicles [ ] , machinery on the ground [ ] and ships in the port area [ ] are also dominated by diesel. schools are invariably sited near busy roads and traffic junctions made worse by the 'school run' that is synonymous with idling engines as parents drop off or wait for their children [ ] . in , schools within london were in areas exceeding the annual mean no eu limit value [ ] . people on low incomes and ethnic minorities tend to be more affected than others by equivalent exposure to air pollutants [ ] and are also exposed to some of the worst outdoor and indoor air quality [ , ] . indoor environments, where most human activities now take place within an enclosed space, are characterised by a chemically diverse and complex air quality [ ] . furthermore, unlike tobacco smoke, healthcare professionals have yet to take effective ownership of the problems that air pollution inflicts on society. on a more optimistic note, and one that this commentary attempts to take, such a challenge should not be regarded as intractable, but one in which there plenty of opportunities and ways, some of which are discussed below, to effectively act and make progress. one of the most significant sources of air pollution in urban areas, where % of the world's population now resides [ ] , is road traffic (exhaust emissions, as well as particles from tyre, brake and road surface wear). it is, as stated earlier, also the source that has repeatedly been shown to cause/worsen asthma. the main traps of concern to health in european cities are pm . (particularly the fraction derived from the tailpipe) and no . in london in the uk, traffic is responsible for around % of no x and % of pm and pm . concentrations at roadside locations [ ] . this is not only due to the significant growth in vehicle numbers, but also to failures of vehicle manufacturers to ensure that they meet emissions limits in realworld driving conditions. across markets, representing approximately % of global diesel vehicle sales, anenberg et al. [ ] reported that over one-half of light-duty and nearly one-third of heavy-duty diesel vehicle emissions are in excess of certification limits. cleaning up the air in heavily populated urban areas to reduce the heavy toll on people with asthma therefore requires a reduction in road traffic as well as a cleaner and greener element to what remains on the road. cleaner fossil-fuelled vehicles require tougher regulations to reduce exhaust emissions, not only for new vehicles, but also afterwards in annual safety/roadworthy tests. commonly cited disincentives aimed at removing the most polluting components of the fleet, i.e. those fuelled by diesel, include levies on fuel, surcharges for parking and the introduction of lowemission zones (lez). however, whilst largescale lezs can deliver improvements in urban air quality, data suggest that, at least in densely populated european cities, more ambitious schemes are required to meet legislative limits and deliver improvements to childhood respiratory health, including asthma symptoms [ ] . the introduction and rigorous evaluation of zones with greater reductions in pollutant concentrations are clearly warranted and may benefit from adjuvant clean air zones that introduce no vehicle idling areas, minimise congestion and support active and low-emission travel through the integration of public transport networks, including park-and-ride schemes. the continued development of new technologies by motor manufacturers in producing vehicles that rely on alternative fuels (electricity, hydrogen) coupled with seamless interfaces with sustainable energy suppliers must also be actively encouraged and incentivised. alternatively fuelled vehicles are not however the sole answer to poor air quality since zero-emission road transport does not currently exist. particulate pollution from road traffic not only includes engine emissions, but also an increasing contribution from brake/tyre wear and road surface abrasions [ ] . it is noteworthy that the potential of non-tailpipe emissions to elicit health effects is largely ignored at the regulatory level despite links with pulmonary toxicity [ ] . to this end, non-tailpipe particulate pollution must be tackled by considering regulation in line with exhaust emissions and innovations in the development of 'safer' tyres, brakes and road surfaces. procurement of appropriate vehicles in the public and commercial sectors is crucially important and nowhere more so than for school buses. data from the usa show that although school bus commutes usually make up only a small part of a child's day, they can contribute up to one-third of a child's -h overall exposure to black carbon during a school day [ ] . moreover, data support the emission reduction benefits of high-efficiency cabin air filtration system [ ] and anti-idling [ ] , as well as health benefits associated with changing fuel from diesel to compressed natural gas [ ] . it should also be stressed that cleaner road transport will not only emerge from the vehicle itself, but also from practices, such improved energy-efficient driving skills that could be introduced through tests and training programmes. for example, a smooth driving style (vs. frequent stopping and starting) ensures that motorists travel steadily at an optimum speed, thereby reducing fuel consumption and in turn air pollution through reduced exhaust emissions, as well as particles emitted from brake and tyre wear [ , ] . the safe and efficient movement of people around towns and cities ultimately necessitates fewer vehicles. this can only be achieved through: ( ) clean, efficient and expanded public transport systems coupled with car share/club schemes and ( ) as much active transport in the form of walking and safe cycling as is feasibly possible. people need to be given more cost-effective and easier alternatives to move through the urban environment, be that on the school run and/or on the commute to work, without necessarily owning a car or taking one out for short journeys. a report by the european court of auditors reveals that commuters in europe are still choosing their cars over public transport, enduring ever-longer journey times into some city centres owing to traffic congestion [ ] . cost, convenience and time-efficiency were all factors cited as challenges in persuading citizens to leave the comfort of their cars for other forms of transport. it is likely however that perception and beliefs also come into play, with car ownership construed to be symbols of success and social status [ ] . the built environment incorporates multiple components that can influence local air quality and in turn ill health. some examples include neighborhood design (walkability, bikeability, connectivity), housing quality, schools, transport facilities (roads, railways, ports, airports), power plants, industrial facilities, accessibility to shops and green space. cities created prior to the introduction of cars tend to be more densely populated and more walkable compared to newer conurbations, which tend to be less populated and more reliant on cars for transport. a vicious circle often ensues in that the mass use of cars in newer cities often goes hand in hand with inadequate public transport, poor infrastructure for active commuting, lack of green space and higher exposures to air pollution. strategies to clean up the air in cities of all ages should focus on the 'cleaner/fewer vehicles' formula already discussed. a cleaner element should be encouraged by not only providing, but also maintaining, adequate charge points for electric vehicles. fewer vehicles will ensue from siting new buildings in locations near essential amenities, thereby reducing the requirement for motorised travel and thus minimising the exposure of vulnerable/disadvantaged groups to inadequate air quality. this could be achieved by locating new homes for essential workers, schools, nurseries and care homes away from roads and avoiding the creation of configurations such as deep street canyons that encourage dangerous concentrations of air pollution to build up [ ] . when air pollution limits are exceeded, local authorities need to act strategically to close or divert roads to reduce the volume of traffic, especially near schools and vulnerable communities. this of course can only be achieved by adequate, accurate and accessible air pollution monitoring programmes. planting trees and the construction of green walls and roofs to create an organic barrier to intercept pm and absorb gaseous pollutants have had mixed results by either improving air quality or in fact worsening it by restricting street ventilation. that the absolute effect of urban greening strategies will depend on factors such street configuration and canopy design means that the appropriate management of urban vegetation (siting, choice of species, maintenance regimes) is critical to maximise potential benefits [ ] . with relevance to asthma, any beneficial and cost-effective to these greening strategies should avoid the use of highly allergenic plants. failure to do so risks marginal gains in air quality being offset by a significant increased risk of exposure to known triggers of asthma exacerbations [ ] . compared to the growth in the volumes of road traffic in the uk over the last years, active transport (walking and cycling) has been on the decline [ ] despite its social, economic and health benefits [ ] [ ] [ ] . well-designed and maintained urban green spaces, coupled with fewer vehicles on the road to permit expanded safe cycle networks, wider pavements and other public areas (as discussed above) will create the much-needed opportunities for active travel. additional mechanisms to promote a step change include mandatory cycle training at schools, cycle-to-work schemes and steps to support cyclists and pedestrians by, for example, providing a choice of routes to avoid highly polluted roads. beyond active transport to reach schools, higher education establishments and workplaces, the provision of pleasant and mixed-activity spaces will also encourage more exercise taken as a form of leisure. a marvellous exemplar is the infamous la ciclovía in bogotá that, every sunday between and hours, hands miles of its usually choking city streets over to over million cyclists, skaters, walkers, runners and other athletes (fig. ) [ ] . this much-loved programme began in as a citizen protest that the city was becoming too car-focused, and now attracts city-dwellers of all ages and social backgrounds who exercise alongside each other through the colourful neighbourhoods of columbia's capital city [ ] . as one of the world's most successful mass recreation events, it has become one of the city's most famous exports. ciclovías have sprung up in numerous south american countries as well as cities in canada and the united states. we need more ciclovías around the world to provide a tangible vision of what a city with more cycle paths and fewer cars might look like, not just for weekly recreation, but also how cities could be designed and run differently. in addition, by truly embracing young children, they can create a generation that look at the street from a completely different perspectiveone that feels like an extension of their driveway and is therefore a safe place for recreation in a dense urban metropolis. promoting physical activity in car-free urban spaces is a double positive for asthmatics in reducing trap, increasing exercise and promoting healthier lifestyles and wellbeing. evolving research suggests that structured exercise routines may help improve some aspects of asthma control. indeed, results from several recent systematic reviews and meta-analyses not only strongly support the safety of structured exercise routines in children and adults with asthma, but also suggest such routines favour improvements in asthma symptoms and quality of life [ ] . up until relatively recently, air pollution was invariably deemed to be solely an outdoor issue, in the general belief that the confines of an inside space, and particularly one's home, offer protection. there are however unique factors which, when combined, have created challenges to indoor living: increased time spent indoors owing to dramatic changes in the lifestyle and working conditions of modern society [ ] ; the transition from natural (wooden floors and woolen carpets) to synthetic (synthetic floor coverings with added stain repellants and flame retardants) materials that have been introduced into indoor spaces [ ] ; the construction of energy-efficient-and with this, airtight-homes that lack inadequate ventilation and promote the buildup of air pollutants [ , ] . in response to these trends and evidence that ill-health, including the severity and/or prevalence of asthma, is heightened by many indoor air pollutants, including no x from gas cooking [ ] , cleaning products [ ] , formaldehyde [ ] , phthalates [ ] , allergens [ ] , mould [ ] and carbon monoxide [ ] , a set of recommendations from experts and young people have recently been published [ ] . this welcome initiative provides wide-ranging advice for government, local authorities, building and child healthcare professions and the public about the changes that are needed ensure that air quality in homes, nurseries and schools does not pose a health risk to children. there is clearly ample evidence to advocate for cleaner air for people with asthma, but since clear and objective scientific assessments are so crucially important to guide the development of evidence-based public health policies, there remains the need for further cross-disciplinary research into the respiratory health effects of air pollution, as well as the effectiveness of mitigation strategies. for example, the independent effects of no and pm are still unclear and need to be deciphered, especially at a time when uptake of electric vehicles is eliminating no emissions, with little of no impact on pm emissions from tyre and brake wear [ ] . another area of uncertainty is the potential of pm from biomass burning to contribute to asthma. this is especially pertinent in the light of the fashionable return of residential wood burning in europe owing to aesthetic appeal and quest to reduce fossil fuel combustion [ ] . research themes applicable to indoor spaces that require greater scientific understanding include the benefits of indoor air filtration, placement of building air intake away from sources of air pollution and vegetative/physical barriers between roadways and homes and schools. such areas of research will benefit from the considerable advances in mobile sensors that can be carried by individuals to monitor personal air pollutant exposure, as well by modeled-based approaches using big data. one such exemplar that is the breathe london: wearables study that provided children and teachers with wearable sensors to carry to and from school to characterise london's school children's exposure to air pollution [ ] . initiatives such as this one, which gathered million measurements, create unique data sets to determine where children may be exposed to elevated concentrations and which forms of transport are more polluting, and to compare air quality within and surrounding schools. validation studies are also reporting coherent epidemiological trends that support the use of smart phone application (app)-sourced data to examine relationships between asthma symptoms and air quality [ , ] . these rapidly evolving technologies will enable estimates of personal air pollution exposures for large populations-currently an elusive goal, but a central one to determine health impacts, evaluate exposure sources, detect susceptible populations and identify intervention opportunities. when individuals, especially vulnerable patients with respiratory problems such as asthma and chronic obstructive pulmonary disease, are exposed to such a well-established and preventable cause of ill health and premature death, our public health and healthcare professionals must have the knowledge to provide sound, evidence-based advice. this requires training about air quality and health risks and being equipped with toolkits to screen and identify at risk populations, raise public awareness, influence behavioural change, help prevent and/or control associated disease and take collective action to bring about positive change. defining patient exposure to air pollution can be difficult since sources and composition vary between communities and within households. one way to open up knowledge and awareness would be for primary healthcare workers to simply pose pertinent questions to patients, alongside those already asked about diet, exercise, smoking and alcohol, and document the answers in medical records [ ] . for indoor air pollution, asking what type of fuel is used for cooking and heating, how the home is ventilated and what sort of cleaning, do-ityourself and personal care products are routinely used may provide important information to help gauge the extent of exposure and advise on lifestyle or products changes that can improve indoor air quality. an understanding of outdoor air pollution exposure requires clinicians to be equipped with reliable local air pollution data supplied by a reputable source, whilst questions to patients should focus on proximity of the household/workplace to urban or industrial environments, commuting practices, occupation and time spent near heavy traffic. additional inquiries to provide a qualitative picture of exposure should focus on outdoor physical exertion (e.g. active transport during commutes, manual work, exercising) and open-ended questions about air pollution in the local community to identify any sources of risk that may otherwise go undetected. such a screening approach will allow clinicians to be better placed to design and discuss individualtailored strategies. recommendations to reduce exposure should always emphasize the importance of avoiding the pollutant source-the most effective intervention. they must also be practical and inexpensive and guard against negative behavioural patterns, such as healthy individuals avoiding outdoor exercise. furthermore, recommendations must avoid advocating the use of inaccurate personal pollution-monitoring devices and any interventions designed to reduce air pollution exposure/the risk of adverse respiratory outcomes that are scientifically unproven. the public must also have access to engaging and high-quality educational materials in primary care and hospital settings. this will go some way in ensuring patients (including low-risk individuals) are better informed on this key issue. as influential members of the community, healthcare workers have a particularly important role to play in advocating for cleaner and safer air on behalf of their patients and thereby advance the global effort to combat the adverse effects of air pollution. a hugely successful analogy is the effective anti-tobacco campaigns that facilitated the smoke-free legislation. the resulting health gains documented worldwide exceeded expectation, including a reduction in childhood and adult hospital admissions for asthma [ ] . outside of clinical settings, approaches to raise awareness of air quality where people, and especially susceptible individuals, congregate (e.g. bus stops, rail stations, shopping areas, etc.) are a crucial as a way of warning of the potential health risks. in an ideal world, people should also regularly check an air quality index (using traditional and social media) or a smart phone app before going to work or school or pursuing leisure activities, prompting them to take action (reduce exposure and/or increase use of inhaled reliever medication) in the event of increased pollution [ ] . alert services accessed via apps are becoming increasingly informative and engaging by providing realtime data and proactively warning registered users of impending pollution events (fig. ) [ , ] . these services also offer tailored advice on how specific groups can reduce emissions by, for example, providing low-pollution journey planners to reduce exposure. the breathe london: wearables study described earlier spans the scientific research/public awareness divide by introducing initiatives such the relatable presentation of collected data to participating school communities, science lessons and surveys/focus groups for children and parents to assess views and perceptions of air pollution [ ] . to recap, we do not have a shortage of evidence to advocate for cleaner air for people with asthma. we know that air pollution is associated with the development and worsening of the condition and, importantly, since we are dealing with an avoidable health risk, mitigating interventions can result in prompt and substantial health gains. we also have a clear target, namely traffic emissions, especially in urban areas, and plenty of potential actions to safeguard the health of people of all ages. this is all good news. a crucial component to what remains is political will, guided by the science, since the recommendations discussed herein would need to be supported by a new clean air act, based upon world health organisation health-based air quality limits, the adequacy of which are currently being revisited. however, deciding upon and executing the necessary policies is a complex challenge when it necessitates among other measures, a reduction in road traffic and a cleaner and greener element to what remains on the road-coupled to a heavy burden of expenditure. policymakers are invariably torn between tightening controls on emissions to enhance health and succumbing to economic pressures not to reduce emissions. several actions in combination must however be taken since multiple measures, each producing a benefit of varying size, are likely to act cumulatively to produce significant change. the response to the coronavirus disease (covid- ) pandemic across the world, in the form of economic rescue packages, has however clearly demonstrated the power of governments and the speed at which they can act when the political will is there and when there is a shared sense of an emergency. we really need to hold onto this, and must guard against voices that may say we need to de-regulate to get the economy going again in a non-sustainable way. in support, findings suggest that the pandemic and, specifically, imposed lockdown measures could result in behavioural changes and thus environmental improvements to benefit those living with asthma. it has clearly given people the opportunity to appreciate how much they depend on exercise in treasured green spaces. there are also glimmers of hope that reduced reliance on the car and increased active travel may emerge. in the uk, an aa-populus poll fig. cityair smartphone app. the app shows: ( ) advice tailored to specific user groups; ( ) air pollution forecast; ( ) low-pollution journey planners survey reported that one-fifth of drivers will use their cars less when restrictions are lifted [ ] . fear of contracting coronavirus on public transport has also led to a boom in cycle-towork schemes, whilst demand for greater mobility and exercise amid lifestyle changes has also boosted bike sales across the uk [ ] . mindset shifts such as these should now be skilfully harnessed with realistic policies and effective measures. in turn, they must be taken forth with political courage and investment so that air pollution no longer contributes to the development or worsening of respiratory ill health. between public health england and imperial college. the views expressed are those of the author(s) and not necessarily those of the nihr, public health england or the department of health and social care. the study was also part supported by the mrc centre for environment and health, which is currently funded by the medical research council (mr/s / , - ). infrastructure support was provided by the nihr imperial biomedical research centre (brc). no rapid service fee was received by the journal for the publication of this article. authorship. all named authors meet the international committee of medical journal editors (icmje) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. disclosures. frank kelly, ian mudway and julia fussell have nothing to disclose. compliance with ethics guidelines. this article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. data availability. data sharing is not applicable to this article, as no datasets were generated or analysed during the current study. open access. this article is licensed under a creative commons attribution-non-commercial . 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and at work in relation to lung function decline and airway poor air quality in classrooms related to asthma and rhinitis in primary schoolchildren of the french cities study associations between selected allergens, phthalates, nicotine, polycyclic aromatic hydrocarbons, and bedroom ventilation and clinically confirmed asthma, rhinoconjunctivitis, and atopic dermatitis in preschool children childhood asthma and early life exposure to indoor allergens, endotoxin and beta ( , )-glucans asthma related school absenteeism, morbidity and modifiable factors current asthma and respiratory symptoms among pupils in shanghai, china: influence of building ventilation, nitrogen dioxide, ozone, and formaldehyde in classrooms diesel, children and respiratory disease lethal but legal: air pollution from domestic burning. london: institute of public policy research wearables study: engaging primary school children to monitor air pollution in london the asthma mobile health study, smartphone data collected using researchkit can smartphone data identify the local environmental drivers of respiratory disease? developing a clinical approach to air pollution and cardiovascular health smoke-free legislation and child health monitoring air pollution: use of early warning systems for public health london air. mobile apps cityair app automobile association (aa) coronavirus: boom time for bikes as virus changes lifestyles funding. this study was funded by the national institute for health research (nihr) health protection research unit in environmental exposures and health, a partnership key: cord- -q rhbroy authors: fischer, alexandra r.; green, sha-rhonda m.; gunn, heather e. title: social-ecological considerations for the sleep health of rural mothers date: - - journal: j behav med doi: . /s - - - sha: doc_id: cord_uid: q rhbroy using a social-ecological framework, we identify social determinants that interact to influence sleep health, identify gaps in the literature, and make recommendations for targeting sleep health in rural mothers. rural mothers experience unique challenges and protective factors in maintaining adequate sleep health during the postpartum and early maternal years. geographic isolation, barriers to comprehensive behavioral medicine services, and intra-rural ethno-racial disparities are discussed at the societal (e.g., public policy), social (e.g., community) and individual levels (e.g., stress) of the social-ecological model. research on sleep health would benefit from attention to methodological considerations of factors affecting rural mothers such as including parity in population-level analyses or applying community-based participatory research principles. future sleep health programs would benefit from using existing social support networks to disseminate sleep health information, integrating behavioral health services into clinical care frameworks, and tailoring culturally-appropriate telehealth/mhealth programs to enhance the sleep health of rural mothers. . moreover, within rural populations, socio-demographic differences and disparities contribute to elevated risk for poor sleep health and other related health outcomes (doering et al. ; mersky et al., ) . individuals located at the margins of mainstream rural communities (e.g., migrant farm workers), with intersectional identities composed of multiple social positions embedded within systems of inequality (lópez and gadsden ) , may experience even more barriers to accessing healthcare (ceballos et al. ; schminkey et al. ) , are currently underrepresented in research efforts (hargraves ; jackson et al. ; schminkey et al. ) , and are underserved in their communities tangel et al. ) . a focus on a modifiable health behavior (sleep) in a vulnerable population (rural mothers) is critical and pressing, especially in light of the current economic and healthcare crises due to covid- , which may disproportionally affect women (thapa et al. ) and contributes to increased distress during the perinatal period (berthelot et al. ) . importantly, dimensions of sleep health are modifiable and can be targeted across overlapping socialecological domains to improve overall health outcomes in rural areas for clinical and general populations (chang et al. ; douthit et al. ; grandner et al. ) . although literature on structural and social determinants of sleep health specifically in rural populations is limited, we draw evidence from other bodies of literature, such as studies of rural ppd in which sleep is featured as a prominent symptom (lawson et al. ; tham et al. ) and is partially accounted for by social determinants (nidey et al. ) . thus, using a social-ecological framework, the current review will highlight existing research focused on the sleep health in rural mothers, identify gaps in the literature, and make recommendations for targeting sleep health in this population. in particular, we outline the social determinants that interact to influence the sleep health of rural mothers with a focus on socioeconomic and ethno-racial health disparities. we apply a social-ecological framework ( fig. ; grandner ) to organize existing literature, and proposed mechanisms by which rural mothers are at a greater risk for poor sleep health, and in turn may be more likely to have negative consequences because of this risk. use of an ecological model can provide clarity about how social determinants impact sleep health beyond an individual focus to include social/interpersonal (e.g., culture) and societal (e.g., public policy) domains that shape health outcomes (grandner ; lópez and gadsden ) . societal, social, and individual-level categories are not entirely discrete; broad societal-level factors influence social and individual contributions to sleep health and vice-versa. however, we organize the current literature around these themes to facilitate identification of gaps in the literature and next steps for this population. societal influences include aspects of larger systems that contribute to sleep health in groups or individuals. some factors are amenable to large scale change (e.g., public policy to reduce sleepy driving); however, studying sleep health likely requires contextual considerations of other immutable factors. to that end, approximately million individuals ( % of the us population) reside in rural america (ratcliffe et al. ) . the geographic isolation of rural communities creates unique challenges for women who need to access comprehensive and coordinated perinatal care, including behavioral medicine services (han et al. ) . rural mothers often live far from their health care providers and subsequently travel long distances for obstetric or specialized perinatal care-a potential source of psychosocial distress and increased risk for childbirth-related complications (dipietro mager et al. ; hung et al. ) . the average distance of travel for rural intrapartum care (i.e. labor and delivery) is miles and access to hospitals with obstetric units with specialized medical staff continues to decline in rural areas at a rate of % from to (hung et al. ) . consequently, family physicians are increasingly relied upon to provide comprehensive postpartum care. (hung et al. ) . this is particularly concerning for the sleep health of rural mothers because family practitioners may have fewer resources (e.g., training, staff) to coordinate behavioral sleep health services for postpartum women . furthermore, women in rural areas report fewer regular sources of specialized women's healthcare (dipietro mager et al. ) and only % of rural family clinics are geographically co-located with behavioral health services, as compared to urban areas in which % of services are co-located (levin and hanson ) . shifts in national and state healthcare policies may contribute to rural healthcare access disparities. in states that did not expand medicaid coverage under the patient protection and affordable care act ( ), low-income women, disproportionally black and rural, reported worse health indicators, less perceived access to medical care, and less preventative care utilization than low-income women in medicaid-expanded coverage states (han et al. ) . indeed, there is a significant gap in coverage for low-income mothers in non-medicaid expansion states because temporary perinatal healthcare coverage may end as soon as weeks postpartum for those who would otherwise not qualify for medicare with income exceeding % of the federal poverty limit (adams and johnston ) . systematic limitations to healthcare access challenge the recommendations of practitioners who overwhelmingly call for more comprehensive postpartum care (american college of obstetrics and gynecology [acog] ), including consideration of behavioral indicators of health such as sleep (hamilton et al. ; sharkey ) . expanded healthcare access for new mothers through national and state policy change is associated with improved health indicators, particularly for underserved populations (dickson et al. ; han et al. ) ; thus, they should be considered for intervention to improve the sleep health of rural mothers. one important aspect of policy change that could enhance sleep health in mothers who reside in non-medicaid expansion states is guaranteeing paid maternity leave. postpartum sleep is associated with highly fragmented sleep in the first weeks postpartum (montgomery-downs et al. ), short sleep duration (doering et al. ) , and excessive daytime sleepiness (filtness et al. ) yet mothers often report returning to work within weeks of giving birth. recently, paid postpartum leave demonstrated positive effects on mental and physical health in australia, particularly for those who had insecure work situations (hewitt et al. ) . while some workers in the us are eligible for weeks of unpaid maternity leave under the family and medical leave act, the us is the only developed nation to not provide nationally protected paid maternity/parental leave (jou et al. ) . racial and ethnic minority residents, who account for - % of rural residents by region, (rastogi et al., ) , may be more vulnerable to poor health and socio-economic disparities that exacerbate poor sleep health in mothers (caldwell et al. ; grandner et al. ; jones et al. ; kumar chattu et al. ; petrov and lichstein ; weaver et al. ) ethno-racial diversity has historically existed in rural communities and it continues to increase with demand for labor in agricultural, natural resources, and construction industries (lee & sharp ; lobao ). yet media imagery and research efforts disproportionately focus on white rural residents . inclusion in an ethno-racial rural minority, such as in the black belt of the southeastern us, may also confer unique strengths and coping strategies that positively affect well-being such as the physical environment, ties to kinship, and spirituality (ceballos et al. ; dolbier et al. ; mollard et al. ) . thus, understanding the complex social context of health disparities for ethno-racial minorities is crucial to addressing the dynamics of intra-rural health disparities, particularly for rural indigenous people, descendants of enslaved people, and recent immigrants affected by the historical context of systematic oppression and contemporary structural inequity (caldwell et al. ; hargraves ; . in sum, at the societal level, the geographic isolation of rural communities and lack of access to healthcare disproportionally affects rural women. future research and healthcare policy initiatives would benefit from examining the societal factors that influence sleep health (i.e., assessing rurality) in mothers. expanding our understanding of intrarural ethno-racial disparities that inform the complex relationship between societal determinants and sleep health would also be beneficial. the community, culture, and interpersonal relationships that shape rural women's lives (e.g., family, socioeconomic position) influence rural maternal sleep health. rurality, strongly associated with low socioeconomic-position, is a strong determinant of sleep health in the general population and partially accounts for some of the sleep health disparities among ethno-racial groups and along the rural-urban continuum (grandner et al. ) . for example, sleep health beyond the first weeks postpartum is more likely to remain poor for mothers of low socioeconomic position and is associated with increased anxiety and depression (sivertsen et al. ; tomfohr et al. ) . the social climate of rural communities may place mothers at a disadvantage in experiencing role strain, a state of increased stress due to competing demands of multiple social roles that is associated with poor mental and physical health outcomes, particularly with ppd (evans et al. ; mollard et al. ) . traditional gender roles and conservative family values are more prominent in rural areas, yet there are fewer jobs that can support single-income families in traditionally male-dominated fields (lobao ) ; there are also fewer jobs with employment benefits such as paid parental leave (lichter ) . therefore, rural mothers commonly return to work sooner than urban counterparts (weaver et al. ) and may need to reconcile a desire to stay at home with the financial necessity of returning to work sooner. for ethnoracial minorities, balancing multiple roles in the context of gender and racism can further compound the balancing of role responsibilities which, in turn, exacerbates role strain (green-davis ; schminkey et al. ) . role strain and socioeconomic-related stressors can be mitigated by the social support network. indeed, social support is related to better sleep and psychological health among mothers of diverse socio-demographic backgrounds (belete and misgan ; mersky et al. ; sinai and tikotzky ) . in rural families, close-knit communities, familial women, and parental partners comprise the core support systems (gjesfjeld et al. ; reynolds and walther ) . literature on social support and sleep health in rural mothers was scarce; however, strong family ties, more intergenerational co-caregiving, and flexibility in parental responsibilities are associated with less risk for ppd in rural mothers (brown and lumley ; edwards et al. ) . social support enhances sleep health, particularly in already vulnerable populations (mersky et al. ) , and rural mothers prefer informal, non-medical advice during the transition to parenthood (mollard et al. (mollard et al. , ; therefore, existing social networks for rural mothers may be considered a resource in disseminating information about sleep health and promoting early intervention. given the risk of false health information about maternal and infant sleep spreading through social networks (craswell et al. ; rouhi et al. ) , collaboration between health professionals and communities could focus on accurate dissemination. this could include training in sleep health promotion and assessment for perinatal in-home visitation care models, peer-to-peer counseling, and structured social networks for new mothers with culturally-relevant consultation with sleep health educators (krans and davis ) . increasingly, mothers are turning to virtual social networking platforms for emotional and instrumental support (craswell et al. ) which could be another avenue of support for mothers facing geographic isolation. in an effort to combat the lack of behavioral health resources in rural areas, technology has facilitated the possibility of behavioral health specialists reaching rural communities through telehealth services (parsons et al. ) . tailored sleep health programs in rural areas through telehealth interventions are promising, but many rural communities do not have affordable, high-quality broadband internet access, which prevents synchronous telehealth interventions from reaching underserved rural areas (drake et al. ). on the other hand, mobile health (mhealth, which only requires cellular service) programs could be used to help mothers manage sleep health during the transition to motherhood, as suggested by emerging research in preventative programs targeting ppd symptoms (dol et al. ; drake et al. ) . most mothers experience changes in sleep quality and quantity during the transition to parenthood, but for some mothers, it can become a more severe problem that is overlooked in clinical postpartum care (acog ; sharkey ) . severe sleep disruption is an almost universal complaint for the estimated - % of women who develop severe psychological disorders after childbirth (e.g., depression, psychosis; lawson et al. ; wilkerson and uhde ) ; therefore, the lack of assessment and treatment of sleep problems, and related mental health disorders, in rural communities is critical (dolbier et al. ; mollard et al. ; weaver et al. ) . although the literature comparing rural versus urban rates of mental health disorders is mixed, it is likely that rural mothers face unique challenges in healthcare access, which can make the burden of mental health disorders more severe. again, the geographic isolation of rural communities translates to declining rates of health care providers in rural areas with specialized training (hamilton et al. ; henning-smith et al. ; hung et al. ) in the unique challenges of maternal sleep (e.g., nocturnal infant care) and the risk of comorbid severe psychopathology. furthermore, the widespread reliance on pharmacologic treatments for behavioral health problems in rural areas (carpenter-song and snell-rood ; metse and bowman, ) is problematic in terms of sleep health; behavioral interventions (e.g., cbti) are considered bestpractice for chronic sleep problems (kalmbach et al. ; van straten et al. ) . moreover, pregnant and nursing mothers often prefer non-pharmacologic treatment due to concerns about the potential teratogenic effects on the health of their children (ceulemans et al. ) . for rural ethno-racial minority populations, access to quality healthcare in rural communities may be worse due to discrimination in interactions with health care institutions (hardeman et al. ) , particularly for black women (hoffman et al. ; smith et al. ) , hispanic/latinx women (schminkey et al. ) , and american indian women (serbin ). there is also emerging evidence that sexual and gender minority mothers, who are more vulnerable to poor sleep health (cunningham et al. ) , may also experience discrimination and barriers to healthcare access in rural communities (barefoot et al. ; puckett et al. ) . mothers in rural communities face geographic isolation, less access to high-quality internet, and barriers to health care in the community, even so, there is strength in closeknit relationships with peers and care providers which can enhance cost-efficient preventative sleep health interventions. for example, maternal sleep health programs could be folded into existing care models such as community-based perinatal care models that use home-visitation, paraprofessional/peer counseling (e.g., doulas, peer health educators), and comprehensive birthing centers (e.g., midwife-led model of care) to improve mother and infant health outcomes while simultaneously reducing cost of care for low-income families (alliman et al. ; dodge et al. ). the societal and social determinants of sleep health described above converge to influence rural mothers' sleep health at the individual level. while it is important to address individual factors, they may be the result of, or influenced by, broader determinants, and should be considered embedded within the social-ecological system (grandner ) . this is particularly important as the field increasingly recognizes that poor maternal sleep and stress are related to-but not unilaterally defined by-infant and toddler sleep patterns (sharkey et al. ; zambrano et al. ) . poor sleep health is a hallmark of perinatal anxiety and depression and it is almost universally present among severe mood disorders and/or postpartum psychosis (bhati and richards ; lawson et al. ; okun et al. ) . ppd is the most common post-childbirth complication, occurring in approximately - % of us childbearing women (bauman et al. ; bhati and richards ; chang et al. ; hasin and grant ; nidey et al. ) ; it is associated with numerous negative physical and psychological health outcomes in mothers and infants (slomian et al. ) . although the literature regarding differences between rural and urban prevalence of sleep and anxiety/depression is mixed, the social context of rural life (e.g., geographic isolation, social stigma) translates to a greater impact on the lives of rural women and their families (chang et al. ) . research would benefit from a deeper understanding of anxiety in rural mothers; indeed, anxiety in mothers may be more pervasive than depression at the sub-clinical level (field ) and may be exacerbated by the stressors of rural life. because of the elevated risk of depression and anxiety associated with poor sleep health, the promotion of sleep health in rural communities could serve as an acceptable and efficacious intervention for better health outcomes overall. rural women may also face barriers in establishing positive health behaviors that are linked to sleep health and that are protective factors against the development of postpartum depression, postpartum weight gain (herring et al. ) , and negative health outcomes, such as cardiovascular disease risk and diabetes (guardino et al. ). these individual health behaviors are all affected by more broad community and societal determinants; for example, mothers in rural areas, especially low-income and ethno-racial minority women, are more likely to have inadequate physical activity compared to urban women. regular exercise is associated with better sleep quality, yet rural women are less active due to challenges in the built environment (e.g., no sidewalks, fewer exercise facilities) of rural communities (bagley et al. ; king et al. ) . the individual factors that shape maternal sleep are influenced by upstream determinants such as socio-economic position and physical environments. as our understanding of the complexity of maternal sleep health continues to grow, the range of interventions to improve sleep health in mothers should include the social context beyond individual characteristics and health behaviors. current literature suggests that sleep health is likely worse, or at least a pressing concern, for rural mothers. sleep health is becoming increasingly relevant in the mood, anxiety, and health challenges that mothers encounter. access to providers and systems, role strain, and cultural values (e.g., independence and mental health stigma) suggest that mothers residing in rural areas may have sleep health issues that are more likely to go undetected and treated. furthermore, for individuals with pre-existing sleep problems or for those who develop sleep problems during pregnancy or after childbirth, there is less access to behavioral sleep medicine resources in rural communities. however, based on the current literature, it is difficult to determine the extent of sleep health problems in this population. moreover, it is not yet known how some aspects of rurality could mitigate poor sleep health. an emerging literature suggests that better sleep health is associated with interpersonal support (gunn et al. ; kent de grey et al. troxel et al. ). in partnered high-income mothers, tangible paternal involvement (e.g., nighttime infant caregiving) is associated with better sleep health (tikotzky et al. ) and at least one finding in a population of low-income mothers suggests social support is associated with better sleep health (mersky et al. ). in addition, belonging to a church community, which is more common in rural areas, is associated with lower odds of ppd (cheadle and dunkel schetter ; jesse and swanson ) . however, we know little of the impact of the types of close relationships that are more common in lowincome rural populations (barnett et al. ) that could be protective of sleep health in new mothers . cohabitating multigenerational co-caregivers (i.e., grandparents) and extended kinship networks (blalock et al. ; brown et al. ) offer tangible social support such as childcare and co-parenting which could offset sleep problems in new mothers. for example, a live-in family member may help a new mother sleep at night by providing nighttime care for the infant. on the other hand, new mothers without these social networks could fare worse due to isolation and loneliness (kurina et al. ) . as outlined below, the literature would benefit from a combination of community-based participatory research efforts to explore the particular sleep health needs of this population, as well as population-based studies of rural residents with expanded analysis of sociodemographic differences (e.g., gender, parity, and race/ethnicity). first, it is important to determine the extent of sleep health issues in rural mothers and identify targets for improving. when advancing towards improving sleep health, we recommend drawing from models in related fields; in particular, a stepped approach to sleep health promotion and integrated behavioral healthcare (krug and umylny ; rybarczyk and mack, ) . the field would benefit from these methodological considerations in identifying the population, drawing out the context, and community-based participatory research. researchers and practitioners would benefit from identifying the rurality of their patients and research participants' community. indeed, clinicians and researchers in urban hospitals and primary care clinics may be already working with rural mothers who bypass local healthcare or do not have providers in their community (radcliff et al. ; sanders et al. ) . socioeconomic position and ethno-racial diversity are rarely accounted for in sleep research (grandner et al. ) , and even less so in perinatal sleep and women's health research nidey et al. ) . population-level studies of regional health disparities would benefit from accounting for gender differences and reporting parity (number of children) for women of childbearing age (evans et al. ; metse and bowman ; young et al. ). in clinical practice, patients could self-identify as rural in their medical records so that clinicians consider this aspect of their care. for example, it may cue practitioners to be sensitive to cultural values and norms in low-income, rural women (e.g., independence, positive thinking) that can impede engagement in psychological treatment . geographically, awareness of the rurality of a patient could invite more flexible modes of treatment delivery (e.g., telehealth services) and coordination with supportive services within their local community. future research would also benefit from drawing out the context of rural sleep health through community-based participatory methodology (israel et al. ) , including qualitative interviews with mothers and practitioners (carpenter-song and snell-rood ) in partnership with local community organizations. using a stepped approach to care, promotion of rural perinatal sleep health can draw support from existing programs tailored for socioeconomically-disadvantaged, ethno-racially diverse women (drake, et al. ; pekmezi et al. ; stevens et al. ) . in particular, trauma informed, intersectional care with collaboration in the community has demonstrated positive gains in health outcomes (sweeney et al. ) . at the societal level, sleep health researchers and clinicians may advocate for public policy changes to expand healthcare coverage for rural mothers. at the social level, sleep health professionals may use existing social support networks to provide accurate information about sleep hygiene, stress management, and infant sleep schedule strategies to promote sleep health for the whole family. in order to expand the availability of behavioral sleep medicine treatment in rural communities, primary care practitioners would benefit from collaboration with remote sleep health professionals through telehealth consultation (parsons et al. ); however, care should not be limited to telehealth. other available interventions may bridge the gap between specialists and community care providers to improve behavioral health care in rural mothers. to that end, to improve sleep health in rural populations, it is useful to draw upon existing, brief and flexible models of behavioral sleep treatments. brief behavioral treatment for insomnia (bbti) is one such paradigm. it is a manualized treatment to reduce symptoms of insomnia through behavioral modification (buysse et al. ) administrable by non-psychologist/psychiatrist health professionals in - sessions with flexible delivery methods (e.g., in-person and remote sessions, or solely via video-conferencing; gunn et al. ) . bbti is suited for rural populations because it requires few office visits (if in-person) and focuses on physiological and behavioral aspects of insomnia which may be more acceptable to those who are distrustful of psychological interventions (buysse et al. ) . furthermore, sleep disturbance may be one of the few modifiable risk factors of ppd (bhati and richards ) . therefore, bbti, or a similar behavioral model, could be a cost-effective and acceptable way to reduce incidence of postpartum depression (swanson et al. ) . while bbti has not been applied to rural perinatal populations, it has been tested in other clinical populations (e.g., older adults, veterans) with overlapping treatment barriers (gunn et al. ) . integrating behavioral health services into rural primary care can also be achieved through increased screening for behavioral health problems (drake et al. ) and provider-led discussions of mental health during perinatal appointments (bauman et al. ) . additionally, focusing on strengthening social support (mersky et al. ) and fostering strong alliances between patients and their health care providers can help improve mental health outcomes for mothers and their families (batra ) . for example, peer support has been helpful in improving adherence to treatment for obstructive sleep apnea (parthasarathy et al. ) and a systematic review by ramchand et al. ( ) found that didactic peer support has led to behavioral changes that positively affect general health outcomes. new mothers often seek advice from friends and family before consulting with a health professional (rouhi et al. ) , therefore, peer-topeer parenting groups could be designed as a cost-effective community-focused program. as previously discussed in the context of social-level influences on sleep health, existing perinatal care models that use peer counseling and strong patient-provider alliances could integrate a focus on sleep health in rural mothers. although such models of care are not necessarily designed for rural populations, collaborative relationships with a focus on social determinants of health may be the best antidote to rising healthcare costs and closure of rural hospitals (parsons et al. ) . sleep health is a modifiable behavior that can influence outcomes in mothers, including postpartum depression and heightened psychosocial stress during the transition to motherhood. research, clinical practice, and program development regarding the sleep health of mothers in the perinatal period would benefit from examining the upstream socialecological determinants, which includes consideration of geographic location (i.e., rurality). considerations for rural mothers, in particular, will advance research among underserved populations and serve as an example of the importance of examining sleep health beyond the individual, while emphasizing the diverse, intersectional nature of social determinants of sleep health. funding this work was supported by the pickens county pilot project grant - , college of community health sciences, university of alabama. conflict of interest alexandra r. fischer has no known conflict of interest to disclose. sha-rhonda m. green has no known conflict of interest to disclose. heather e. gunn havs no known conflict of interest to disclose. this article does not contain any studies with human participants or animals performed 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vs rural residence and the prevalence of depression and mood disorder among african american women and non-hispanic white women perinatal sleep problems dietary behaviors and poor sleep quality among young adult women: watch that sugary caffeine! sleep health it's not all about my baby's sleep": a qualitative study of factors influencing low-income african american mothers' sleep quality key: cord- -ncot tvn authors: hansstein, francesca valeria; echegaray, fabián title: exploring motivations behind pollution-mask use in a sample of young adults in urban china date: - - journal: global health doi: . /s - - -y sha: doc_id: cord_uid: ncot tvn background: wearing a pollution mask is an effective, practical, and economic way to prevent the inhalation of dangerous particulate matter (pm). however, it is not uncommon to observe negligence in adopting such behaviour, and this especially among young segments of the population. using the theory of planned behaviour (tpb) as conceptual framework, this study explores the role of socio-cognitive factors that affect the decision of wearing a pollution mask in the context of young educated people. this is done by selecting a sample of college students in urban china, a country that has seen air quality as one of the major challenges in the last decades. while young urban college students might be expected to be receptive to standard attempts to be influenced through reason-based cognitive stimuli, it is often found that this is not the case. the empirical analysis was articulated it in two steps. structural equation modelling (sem) was first used to examine the relationships among the conceptual constructs derived from the tpb conceptual model, and second step-wise ordinary least squares regressions (swols) were employed to observe the partial effect played by each item on the decision to wear a mask. results: results show that, while reason-based stimuli play a role, attitude, social norm, and self-efficacy were the most important predictors of the behavioural intention (p < . ). the role of past behaviour was also acknowledged as strongly associated with the dependent variable (p < . ). overall, the likelihood of wearing a pollution mask increases with the importance of others socio-cognitive and psychological factors, which could help understand behavioural biases, and explain the relative role of several mechanisms behind the decision to wear a mask. conclusions: while tackling pollution requires multiple and synergic approaches, encouraging self-prevention using pollution mask is a simple and effective action, implementable at negligible costs. resistance among younger, well-educated cohorts to wear masks can be overcome by stressing the social desirability of action and the sense of empowerment derived from its usage. this study has the potential to inform policies aimed at changing suboptimal behavioural attitudes by identifying triggers for change, and it could serve in improving the tailoring of health promotion messages aimed at nudging healthy behaviour. electronic supplementary material: the online version of this article ( . /s - - -y) contains supplementary material, which is available to authorized users. since the beginning of its rapid economic development, china started experiencing one of the worst air pollution emergencies in the world's history, affecting especially urban areas and that has become one of the leading threats to public health [ , ] . according to the yale and columbia university's environmental performance index, and with the exception of a handful of poor nations, china's pollution trails all developed and developing countries, and ranked second to last in air quality [ ] . particulate matter of inhalable and respirable size fractions (i.e. pm and pm . ) represents the air pollutant of greatest health concern in urban china [ , ] due to their microscopic size particles of this nature easily enter the human respiratory system, contributing to respiratory illnesses.. moreover, prolonged exposure to air pollution has negative effects on cognitive abilities later in life [ ] , whereas expecting mothers can experience a higher frequency of pregnancy complications related to excessive exposure to pm [ ] . in terms of tangible health effects caused by pollution, low-educated and elderly females are the most vulnerable population segment [ ] . in addition to the negative effects on individual health, air pollution represents a direct drag on public resources by rising costs for the health system, and an indirect hindrance to the economic and social order by incentivizing mass emigration. in , the chinese government has launched a five-year plan to radically tighten air pollution and initiated a process of green growth and development. during the asia-pacific economic cooperation in , the chinese government successfully implemented rigorous emission reduction initiatives to lower air pollution levels in the city of beijing [ , ] . the experiment achieved excellent results, demonstrating that pollution can be tackled with adequate policy measures. however, the positive effects of these measures on health are likely to emerge in the long-run. far less clear is government success in redressing pollution effects upon individuals and in affecting individuals to responsibly handle preventive health measures when dealing with pollution. the chinese government took in fact several initiatives and leveraged on mass media dissemination to encourage prevention against pollution. these included, for example, the daily reporting of environmental conditions, the dissemination of scientific knowledge about the adverse effects of pollution exposure, advising sensitive groups like the elderly, children, or people with respiratory diseases against spending long periods outdoors and several others. among the solutions to reduce exposure to air pollution are: (a) staying indoors with air purifiers, (b) avoiding physical activity during severely polluted days, and (c) reducing frying of food and smoking at home. one of the most effective alternatives to reducing personal exposure to particulate matter, specifically outdoors, is also wearing a pollution mask. the promotion of pollution mask wearing has been one of the core government-initiated programs to guide individual responses to pollution exposures. however, in spite of public promotion, being a practical and straightforward form of self-prevention, as well as one of the cheapest, it is found that a large number of individuals do not wear a pollution mask during polluted days. this resistance is stronger among the youngest and best educated people of big cities in the country, who interestingly are also the ones more easily targeted by those initiatives of government officials aiming at a wide dissemination of information, warnings, and best practices to protect against pollution [ ] . this is puzzling to some extent, and suggests that, because of the extreme cost effectiveness and accessibility to masks, most of the impediments to adopt such a healthy habit are likely to be found in behaviours informed and conditioned by individual attitudes and social pressure. moreover, the efficacy of facemasks in preventing the inhalation of pm has been successfully tested, and previous research has shown that there are immediate positive outcomes on blood pressure and heart rate [ ] . finally, masks are a useful tool to protect individuals from the transmission of acute respiratory infections and pandemic influenza [ ] . however, to our knowledge, there is no study documenting the reasons for the lack of adherence to mask-wearing registered especially among the youngest population. this paper aims at filling this gap, and provides empirical evidence gauging the relative contribution of extra-cognition stimuli in driving accurate preventive behaviours regarding pollution facemask use among young, well-educated, and urban chinese population. this is the population segment with the greatest resistance to adopt risk-averse health practices when dealing with pollution. to conduct the empirical investigation, the theory of planned behaviour (tpb) was applied to determine the role that socio-cognitive factors play on the decision of wearing a pollution mask among a sample of chinese students. at this scope, two quantitative analyses were employed. the first is based on structural equation modelling (sem); this methodology was used to examine the relationships among conceptual constructs measuring the intention to wear a mask. the second model used step-wise ordinary least squares regressions (swols) to estimate the marginal effect of each item, identified at the sem stage, on mask wearing intention. beyond simple utility-based rational models of behaviours, the literature acknowledges a diversity of reasons behind the use of facemasks. awareness of adverse consequences towards future health, as well as raw fears for personal wellbeing, are among the more emotional forces reported by the literature [ , ] to trigger the use of facemasks. likewise, environmental conditions also seem to drive behaviours, given that a -point increase in the air quality index (aqi) has been linked to an increase in the purchase of facemasks by . % and anti-pm . masks by . %; in fact, the search of the word "mask" (口罩 in chinese) on internet search engines escalated in days with a high the aqi [ ] . emotional reactions are fed by perceived effects of air pollution which implies that individuals first and foremost develop attitudes based on perceptions and assess the extent to which the target behaviour is within their reach. additionally, the elasticity of demand for face mask suggests that affordability issues do not impair individuals from adopting the behaviour if they want so, in other words, they don't feel disempowered to perform the action. given the shortcomings of cognitive modelling of action for facemask use, socio-psychological stimuli should be recognized as influential like how individuals perceive the legitimacy of performing the target behaviour, their ability and capacity to do so, and how this target behaviour is associated with positive feelings. the theory of planned behaviour (tpb) [ ] assumes that individuals make choices based on weighting the possibilities and obstacles to enact the expected action, and thus building a sense of confidence in actually achieving desired results, their broader feelings towards the action at stake, and their surrounding social context. other forces may be at play as well such as their past reactions to similar situations. previous research had proven the validity of the theory-based psychological models in explaining the intention to take preventive measure for limiting the health effects of air pollution [ , ] . our hypothesis is that other influences like the prevailing social norms, inertial reactions replicating past behaviours, and the perceived feasibility of implementing new behaviours have also a role in making sense of unhealthy personal choices. tpb proposes that behavioural intention is determined by attitude towards the behaviour, subjective or social norm, and perceived behavioural control (pbc). three types of perceptions influence involvement with the target action: (a) the perceptions of how socially acceptable or mandatory the intended behaviour among individual's salient reference groups is (i.e., social norms); (b) the perceptions of how easy or hard it is to set such behaviour in motion, in other words, the perceived capacity of overcoming barriersor to take advantage of facilitatorsto engage the behaviour (i.e., pbc); (c) and lastly the perceptions of how likeable or unwanted the intended behaviour pictured in people's minds is, mostly based on the perceived relevance and payoffs of the consequences of enacting such behaviour (attitudes) [ , ] . tpb is one of the most widely applied theories for health prevention, while also contributing to the understanding and overcoming of behavioural-change resistance [ ] (fig. ). this study employed an exploratory sequential mixed methods research design. a preliminary qualitative phase on a small sample of the target population -to elicit the salient beliefs towards the behaviour and to build the questionnaire -was followed by data collection and the quantitative analysis. qualitative research also enabled the validation of how expressions of social norms, perceived behavioural control and attitudes towards mask use actually play a role in students' calculus of mask use, together with the recognition of other forces influencing choice such as past behaviours, that is, the influence of inertial behaviour. to evaluate the appropriateness of the questionnaire items, a principal component factor analysis was first performed, and, as a second step, the model constructs were built using the mean score method. in particular, for each respondent, one score was calculated as the mean of the answers to the items. the main difference between factor-score and mean-score method is that mean score assumes that each item is equally important to the concept being measured, while factor score does not. in our analysis, the assumption was met so constructs were calculated using the mean score method. in addition, the interpretation of the mean score is straightforward because each construct has the original scale used for the items. secondly, the mean score manages missing values more efficiently [ ] . the dependent variable of this study was measured based on respondents' degree of agreement towards seven different behavioural reactions all connected to wearing a pollution mask when confronted with a very specific situation which is "if the aqi is higher than and i have to stay outdoors for more than one hour". it is fair to acknowledge that the average aqi during fieldwork did not reach . those seven reactions related to ) expecting, ) wanting, ) choosing, ) intending, ) preferring, ) suitability, and ) future commitment to use a mask. a seven-point likert scale was used to identify the level of agreement with each reaction. to account for the nominal heterogeneity behind construct's content, the measure included a variety of states which demand different intensity of individual commitment to action. all reactions cluster together yielding a high cronbach's alpha reliability index of . . accordingly, the intention to behave construct is thereby robustly measured. the need for specifying in greater detail the exact context of performing the action (that is, reaching aqi higher than ) derived from the former round of qualitative research which clearly suggested that a context-free assessment of pollution-related preventive behaviours would have led to a problematic unbinding of the action, which in turn stimulated overstatements about individual unwillingness to adopt health-conscious practices. the other measures of the standard tpb model also followed a multi-item construct composition. attitudes towards the behaviour aims to measure the perceived consequences and value of performing the action and thus was measured using a seven-point likert scale that grasped the agreement with the idea of wearing a mask as ) necessary, ) effective, ) beneficial, and ) useful. except for the latter item which loads at . , all other items have a high correlation to the latent trait, and therefore contribute to yielding a valid and reliable construct. cronbach's alpha for the construct was . . social norms capture the surrounding environment of pressures and conformity to other people's expectations with regards to using a facemask against pollution, thus it was measured as the perceived reaction of four groups: ) parents, ) friends, ) schoolmates, and ) roommates to that behaviour, using a seven-point likert agreement scale. the inter-item correlation was sufficiently high to yield a highly satisfactory cronbach alpha coefficient of . . our study also included questions for perceived behavioural control (pbc) and self-efficacy. pbc relates to the possibilities that action could be performed in practical terms and the degree of confidence that initiatives taken will amount to the desired behaviour and the expected outcomes from it. self -efficacy is a key factor in explaining the adoption of health-related behaviours and is in fact always included in many health behavioural models [ ] . although there are criticisms in the literature towards the measurement redundancy of pbc and self-efficacy [ ] constructs were kept separated in this research following the approach of similar studies examining health behaviours or college students [ , ] . these studies effectively demonstrated the separability of the two concepts: one side there is the perceived confidence in individual ability to achieve the behavioural outcome, on the other the belief that the outcome can successfully be influenced by one's own effort. from an empirical point of view, in our study, while pbc measured the role of objective obstacles (like accessibility and affordability), the question on self-efficacy was intended to measure the general subjective evaluation on oneself capacity to succeed in performing the specific task, which is not just simply wearing a mask, but also adopting self-preventive behaviours. buying an anti-pollution mask on campus is a relatively easy task -therefore unrelated to individual self-efficacy. it seems reasonable to acknowledge that a simple task like buying a mask cannot necessarily affect the target behaviour whereas the belief that wearing a mask can successfully protect ones' health may drive the behavioural intention. this was also confirmed by the low correlation between the pbc and self-efficacy items (r = . ). lastly, in order to better specify the model and given its weight in shaping health prevention choices past behaviour was also included in the analysis. this choice integrates the role of habits and, mainly, prior experience. a meta-analysis research on health behavioural determinants has shown how the addition of past behaviour increased by % the variance explained by the core constructs. when possible, the inclusion of past behaviour is recommended for a better model's specification and more precision in coefficient estimation. it captures the essential role of habit in shaping the behavioural intention and it has also found to attenuate the role of other attitude [ ] . past behaviour was measured asking first: in the last year (s), did you wear a pollution mask during high polluted days? and then for those who answered positively, the variable's frequency was recoded to be consistent with the other constructs (how often, from never to always). the questionnaire was administered in chinese and was translated into english for dataset building and data analysis purposes (see additional file for more information). survey data were collected between nov and nov , , and a total of respondents participated in the study. of these, completed the questionnaire, thus leading to a completion rate of %. during the days of data collection, the average aqi was . (respectively , , and ). for this average aqi level government indicates that slight irritations may occur; individuals with breathing or heart problems should reduce outdoor activities. this study employed a convenient sample, and participants were recruited among students living on campus in shanghai. although this choice can introduce a bias in the generalization of the results, the primary goal of this study is to study the factors affecting the behaviour within an educated and urban sample of chinese young individuals. a more detailed discussion about the use of convenience samples can be found in the discussion. informed consent was obtained from all participants included in the study. interviewers were properly trained on how to conduct the survey and responses were collected via self-administered questionnaires. also, the interviewers were reachable anytime in case the respondents needed some clarification. this procedure left respondents the privacy to reflect and answer the questions, and, at the same time, guaranteed the comprehension of the items in case they needed clarifications. table reports a detailed description of the variables used to calculate the model constructs, together with the cronbach's alpha and factor loadings for each item. cronbach's alpha is a measure of internal consistency and indicates whether a measure is one-dimensional. the minimum standard accepted threshold is . . similarly, factor loadings indicate how much variability of each item is correlated to the latent construct (in this case, factor ), with values above . it is considered very good [ ] . descriptive statistics were first calculated to determine the distributions of the core model constructs. structural equation models in the form of path analyses were performed to evaluate the relative impact of each construct on the intention to wear a pollution mask. the fit of the model was assessed through the examination of these fit indices: chi test, the comparative fix index (cfi) and the root mean square error of approximation (rmsea). table presents the descriptive statistics of the core variables. overall, % of respondents were females, and % males; % came from urban areas, and % had a rural origin. respondents were on average years old. although the mean value of the construct intention was quite high ( . ), the average of the frequency with which respondents used a facemask in the past was quite low ( . ). subjective norm, attitude, self-efficacy, and pbc were also relatively high. the next step was to estimate the structural equation model in the form of path analysis using maximum likelihood method. the model with standardized coefficients and p-values is reported in fig. . except for pbc, attitude, social norm, and self-efficacy were all statistically associated with behavioural intention (their coefficients were, respectively β a➔i = . , β sn➔i = . , and β se➔i = . , p < . ). in the model' s structure, past behaviour was employed as a proxy for actual behaviour. the path connecting intention to behaviour was units, as in our case, it is very common to obtain a significant chi-square, even when the model is accurate [ ] . therefore, other fit indices should be considered. the cfi is above . indicates that our model does % better than a null model that assumes that all the coefficients are unrelated to each other, but the ramsea not below the recommended . . in order to observe how each model factor affected intention, ols stepwise regression models were successively run. as reported in table , each model adds a new predictor in the specification. as long as more constructs were included in the model, the r-squared substantially improved, going from r = . in model where only attitude was included, to r = . in model were all the predictors were added. attitude, social norm, self-efficacy, and past behaviour were all positively related to the intention of wearing a pollution mask and also highly significant (specifically, β a = . , p < . , β sn = . , p < . , β sn = . , p < . , β pb = . , p < . ). pbc was instead not significantly correlated with intention. with the worsening of the air quality, the chinese population' s awareness of both the issue itself and its health consequences has rapidly increased [ ] . underperformance of risk-averse behaviour seems more acute among a human asset of crucial importance for the country: its college-level generation. this paper was intended to describe the effects of a wider set of influences beyond information exposure to understand the actual triggers which are more likely to favor the intention of wearing a pollution mask. highly educated individuals, i.e., young college students, a segment of the population which is plausibly quite able to understand and assimilate cost-benefit analysis and efficiently conduct the rational processing of scientific information would be expected to respond positively to reason-based cognitive stimuli. yet, social norms, self-efficacy, attitudes, and past behaviour, all clearly played a critically important role in the decision of wearing a mask. our findings suggest that young chinese college students condition their use of pollution mask to what their social circle think of it, in particular friends and roommates. the social legitimacy of this action is a critical shaper of their intentions. accordingly a language and approach that reinforces social adequacy and "coolness" of the target behaviour may prove effective in mobilizing facemask use through peer-pressure. this finding falls in line with studies showing how social pressure critically influenced mask wearing during the outbreak of sars [ ] as well as for favouring other health prevention measures especially among youngest cohorts [ ] and during quarantine times [ ] . an individual's perception of his/her competence to enact the action is also critical, as epitomized by the high loading of the self-efficacy variable. interestingly, this effect runs independently of individual perception of external obstacles or facilitators to attain the ultimate result. this finding echoes other studies analysing the role of self-efficacy in following preventive behaviours [ , ] . accordingly, appealing to this sense of impact of one' s confidence in implementing the behaviur is critical to scaling up facemask use. conversely, given that wearing a pollution mask requires little volitional control, behaviour control-related barriers like price, quality, and brand recommendation hardly determines the odds of performing the target behaviour. naturally, the practical irrelevance of tpb for facemask use cannot be extended to other health prevention behaviors. in fact, tpb has proved greatly effective in shaping early cancer screenings and use of seat-belts [ ] . our study also confirmed the importance of past behaviour which, in this case, strengthens the relationship between intention and behaviour by acting as an intention stabilizer. in general, the inclusion of past behaviour had been shown to improve the prediction of future behaviour and, also, had sometimes been found to be the only significant predictor [ ] . this validates the analytical gains of putting behavioural change into a broader and more realistic context than merely knowledge exposure. it also signals the potential advantages of identifying a more effective mobilizational language to encourage a wider embracement of the proposed action. in the health promotion literature, there are several examples on how by slightly changing behavioural triggers, or by adding almost-invisible nudges, individuals are more likely going to adopt healthier behaviours [ ] . past evidence has proven how public health programs aimed at increasing the adoption of preventive behaviour are more successful when the health intervention design includes the understanding of the complexity of the behavioural determinants [ ] . the variations in individual responses to smog are also critical to the development of adequate public policies, as well as interventions to promote changes in behaviours [ , ] . besides government and universities' actions aimed at reducing pollution levels by rackling the sources of it, self-protection measures are taken at the individual level, and are not homogenous among different echelons of the society. a recent study from zhang et al. [ ] found for example that richer and urban chinese are much more likely willing to invest in anti-pollution masks and air-filters. our study suggests that knowledge-intensive approaches to mobilize individuals towards new health-preventive behaviours do not warrant successful results. to succeed, government and institutional programs are required to support the adoption of new habits by framing them in a language of social legitimacy, that is, by building a narrative of the expected behaviour that socially relevant references (peers) demand from the individual or in terms of levelling up with the socially acceptable behaviour already set in practice by relevant personal references (legitimacy). communication approaches that motivate mask-wearing in social neighbours or convoke to champion one's social circle by meeting loved ones' expectations to take care of one's health may prove effective. a language around social comparisons may thus prove effective. consequently, given the salience of social norms (particularly among educated youngsters) using celebrities, key opinion leaders, or authoritative spoke-persons to highlight the reputation gains of adopting new behaviours (or the embarrassment of not doing so) can help overcome resistance or indifference. conversely, our results suggest that it might be pointless to emphasize exclusively accessibility of affordability issues, or execute any action on those table step-wise ols regression, beta and standard errors in parenthesis controls for gender, residency, and age were also included notes: beta and se; *** p-values < . domains, as these are not recognized as obstacles or barriers towards higher pollution mask use among students. in other terms, as these conditions are necessary, they might be confused as sufficient factors leading to the straight adoption of the intended behaviour. on the other hand, interventions aimed at altering the opportunity costs of maintaining forms of social status and self-image, as acquired from adopting or omitting the advocated behaviour, might reveal themselves more effective and successful. this has to work both on the side of self-perception and peer-effect. this study has one limitation that needs to be acknowledged. it relates to the sample which is composed of students, not a representative cross-section of population, therefore it is not possible to stretch inferences to urban china as a whole. having said that, given that young, highly educated urban chinese seem to compose one of the groups more resistant to adopt this health prevention measure, it makes sense to prioritize motivations for mask use among this social segment. arguments for and against the use of college students as research subjects have tended to focus on whether results obtained from such subjects are generalizable to non-student populations. in our case, and for the reasons reported above, this research is less subject to this critique, as it is already studying the population of interest, and is less in need to justify the external validity of our effort. researchers such as kardes [ ] and lucas [ ] have argued that college students are appropriate research subjects when the research emphasis is on basic psychological processes or the theory tested links to human behaviours independent of sample characteristics. according to berkowitz and donnerstein [ ] , the "meaning the subjects assign to the situation they are in and the behaviour they are carrying out plays a greater part in determining the generalizability of an experiment's outcome than does the sample's demographic representativeness." however, other researchers, such as sears [ ] and gallander, north, and sugar [ ] , have expressed unease about the use of a narrow database of college students in behavioural research. in particular, sears suggests that what is apparently "known" about humans is biased because college students tend to have stronger cognitive skills, less crystallized attitudes, more compliant behaviour, and less stable peer group relationships than older adults. it cannot be denied that such characteristics can endanger the external validity of survey studies. however, in our case, these are all factors that help understanding better the main mechanisms, as these underlying characteristics have at least been found to be salient when talking about healthy behaviour in this framework. while the risks of over response cannot be denied, selecting individuals possessing on average stronger cognitive skills would certainly bias our findings, but in the sense that responses are stronger not weaker in the whole population, given that non-rational drivers would presumably be amplified in this second case. this might at least in part mitigate our bias. despite the low cost, accessibility, and easiness of using pollution masks, and notwithstanding the public campaigns and media coverage stressing the associated benefits of their usage, numerous individuals struggle to adopt 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response to criticisms about research based on undergraduate participants: a developmental perspective social psychology of seat belt use: a comparison of theory of planned behavior and health belief model the authors would like to thank their two research assistants, ms. sherry when and ms. liang yuqi, for their excellent support in data collection, database building, and data cleaning. thanks also to ms. marilyn fisher for her help in editing the manuscript. we also would like to thank the participants to the conference environmental pollution and public health (epph, suzhou ) for their helpful insights, and professor alberto batinti, for his useful and thoughtful comments. this study was supported by the individual research funding from shanghai university of finance and economics. all data generated or analysed during this study are included in this published article [and its additional file ].authors' contributions fh was responsible for the research design, data collection, statistical analysis and part of manuscript writing. fe was in charge of manuscript writing, especially concerning the theoretical implications. both authors read and approved the final manuscript.ethics approval and consent to participate participants were given both oral and written information regarding the aim of the study, purpose of the interview, research methods as well as methods for ensuring confidentiality. participation was voluntary and data anonymous. the research design and questionnaire was in compliance with the ethical standards of the shanghai university of finance and economics. formal approval of the study with a reference number is not applicable / required. not applicable. questionnaires were anonymous and all data are presented in an aggregated form. the authors declare that they have no competing interests. key: cord- - rxhkg a authors: sun, xinying; shi, yuhui; zeng, qingqi; wang, yanling; du, weijing; wei, nanfang; xie, ruiqian; chang, chun title: determinants of health literacy and health behavior regarding infectious respiratory diseases: a pathway model date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: rxhkg a background: health literacy has been defined as the degree to which individuals have the capacity to obtain, process, and understand the basic health information and services needed to make appropriate health decisions. currently, few studies have validated the causal pathways of determinants of health literacy through the use of statistical modeling. the purpose of the present study was to develop and validate a health literacy model at an individual level that could best explain the determinants of health literacy and the associations between health literacy and health behaviors even health status. methods: skill-based health literacy test and a self-administrated questionnaire survey were conducted among chinese adult residents. path analysis was applied to validate the model. results: the model explained . % of variance for health literacy, . % for health behavior and . % for health status: (gfi = . ; rmr = . ; χ( ) = . , p = . ). education has positive and direct effect on prior knowledge (β = . ) and health literacy (β = . ). health literacy is also affected by prior knowledge (β = . ) and age (β = - . ). health literacy is a direct influencing factor of health behavior (β = . ). the most important factor of health status is age (β = . ). health behavior and health status have a positive interaction effect. conclusion: this model explains the determinants of health literacy and the associations between health literacy and health behaviors well. it could be applied to develop intervention strategies to increase individual health literacy, and then to promote health behavior and health status. health literacy has been defined as the degree to which individuals have the capacity to obtain, process, and understand the basic health information and services needed to make appropriate health decisions [ , ] .over the last decade, health literacy has become a hot spot of research [ , ] . with a deeper understanding of health literacy in academic circles, more and more researchers find that a lack of health literacy can cause some adverse effects for individuals and society. low literacy is associated with a variety of adverse health outcomes, including increased mortality, hospitalization, and in some cases poorer control of chronic health conditions [ ] [ ] [ ] [ ] [ ] . additionally, limited health literacy impacts on the prevention and screening of diseases, health behavior, the taking of patients' history and the interpretation of diagnoses [ ] [ ] [ ] [ ] [ ] . knowing little about preventive care, people with low health literacy tend to use more medicines and more expensive healthcare services, including hospitalization and emergency services [ , , ] . some investigators have elucidated explained the relationship of between limited health literacy and socioeconomic indicators, health behaviors, and health outcomes [ , ] . researchers have focused on explaining the potential mechanisms between these variables. aging, the language barrier, low education, bad socio-economic status and suffering from chronic diseases were all regarded as risk factors of limited health literacy [ , ] . though limited health literacy has been shown to be associated with worse health outcomes and some socioeconomic characteristics, the causal pathways are not entirely known. several researches have focused on explaining potential mechanisms. the conceptual model by baker illustrates these hypothesized relationships by highlighting individual capacities that are associated with literacy skill, the complexity of both printed and spoken health information and other factors such as cultural norms that are relevant to health outcomes [ ] . in , paasche-orlow and wolf proposed a conceptual causal model to explain associations between limited health literacy and health outcomes [ ] . in their model, socioeconomic indicators are the basic factors influencing health literacy. these include level of education reached, ethnicity, age, occupation and income. their model distinguishes three different types of health action that mediate the impact of health literacy on health: access to and utilization of health care, patientprovider interaction, and self-care. each of these domains is defined not only by patient factors but also by external factors that can be attributed to the health care provider or the health system. the pathways are particularly useful in highlighting the role of health actions and providing a useful taxonomy of behavioral domains. von wagner's review introduced a framework drawing on ideas from health psychology and proposing that associations between health literacy and health outcomes could be mediated by a range of health actions involving access to and use of health care, patient-provider interactions, and the management of health and illness [ ] . the framework outlines ways in which health literacy might affect either health actions themselves or their motivational and volitional determinants, which have been identified in social cognition models. mccormack established a conceptual framework for individual health literacy [ ] . the framework illustrates how health literacy functions at the level of the individual, while acknowledging that factors external to the individual (including family, setting, community, culture and media) influence all the relationships represented in the model. the framework is organized into four primary elements: ( ) health-related stimulus; ( ) factors that influence the development and use of health literacy skills, including socio-demographic characteristics, resources , prior knowledge and capabilities; ( ) health literacy skills needed to comprehend the stimulus and perform the task; and ( ) mediators between health literacy and health outcomes including motivation, attitudes, emotions, and self-efficacy. the health related outcomes include behaviors and status. although all these models or frameworks have given the relationship between socio-demographic characteristics, prior knowledge, health literacy, health behavior/action and health outcomes, they are all theoretical explanations. few studies have tried to validate them through the use of statistical modeling. so this study aimed to develop a health literacy model and to statistically validate it using path analysis. with the models of baker, paasche-orlow, von wagner and mccormack for reference, we proposed a health literacy model at an individual level. figure represents this model. in this model, socio-demographic indicators, including age, gender, level of education reached, occupation and income, are the basic factors influencing other variables. besides socio-demographic indicators, prior knowledge also influences the development of health literacy skills. then health literacy has direct effect on health behavior, meanwhile, as a mediator between prior knowledge and health behavior. finally, health behavior influences health status. the first part of the questionnaire was concerned with socio-demographic characteristics including age, gender, ethnicity, household registration status, marital status, education, occupation and income. the second part measured knowledge of infectious respiratory diseases, known as prior knowledge. questions were asked about the different types of infectious respiratory diseases and their prevention methods. the maximum possible score for this part of the questionnaire was . the third category asked about individual behaviors and actions including washing hands, wearing a face mask, sneezing, room ventilation and treatments for infectious respiratory diseases. the maximum possible score for the health behaviors category was . the last part of the questionnaire was concerned with individual health status. information sought included how frequently the subject fell sick, how often they saw a doctor, the degree of severity for each sickness as well as the duration of the sickness. this category was marked with a maximum score of . a skill-based health literacy instrument was established using ratzan and parker's ( ) definition of health literacy: "the degree to which individuals can obtain, process, understand, and communicate about healthrelated information needed to make informed health decisions [ ] .the instrument included sixteen stimuli materials involving the distribution of epidemics, immunization programs, early symptoms, means of disease prevention and individual's preventative behavior. the instrument included five different subscales: print-prose, print-document , print-quantitative, oral and internet. the print-prose scale measured the knowledge and skills needed to search, comprehend, and use information from texts that were organized in sentences or paragraphs, while the printdocument scale measured from non-continuous texts in various formats. the print-quantitative scale measured the knowledge and skills needed to identify and perform computations using numbers embedded in printed materials [ ] . mccormack developed a more comprehensive measure of health literacy, named the health literacy skills instrument (hlsi). similar to other studies, this instrument measures print literacy. however, it was innovative in that it also uses non-print stimuli and examines oral and internet-based information seeking skills [ ] . in this study, oral literacy was tested though six questions from three pieces of audio or video. we too used nonprint stimuli and measured oral and internet-based skills, but we did so using a series of questions to test the ability of internet-based information seeking rather than having the participants actually seek information online. the measurement instrument consisted of items ( table ) : five concerning print-prose literacy, eight for print-document literacy, six for print-quantitative literacy, six for oral literacy and five for internet-based information seeking literacy. the overall degree of difficulty and discrimination of the instrument were . and . respectively. the instrument demonstrated good internal consistency reliability with a cronbach's alpha of . . as for validity, confirmatory factor analysis showed that the items were grouped into five subscales representing prose, document, quantitative, oral and internet based information seeking skills. while the first three instruments pertained to print health literacy, the between may and december , surveys were carried out in beijing city (the capital of china), datong city (in shanxi province, north china) and shenzhen city (in guangdong province, south china). multi-stage sampling was employed. the target population was first stratified into residents from cities and residents from villages (living in cities at the time and having lived for more than months), with an equally divided sample size. they must be more than years old. then, based on the principle of balancing samples among factors like age and occupation, cluster sampling was conducted in six places where locals gather (including communities, factories, government organizations and other institutions), and six places where non-local residents gather (including hotels, building sites, assembly shops and employment medical examination centers). the sample size was calculated by the function n = z -a/ p ( − p)/d × deff. according to data obtained from the national health literacy survey in regarding health literacy towards infectious diseases, the expected percentage was % (p = . ) [ ] . the minimum sample size is . considering recovery rates and efficiency rates of the questionnaire, the actual sample size should be at least . in total, residents responded to the survey. the study received approval from the peking university institutional review board and the approval number is irb - . it was also accordance with helsinki declaration. the investigations were performed in large multimedia conference rooms. the survey was carried out by trained investigators. information about the study was provided by the investigators and informed consent was obtained from each participant. all participants were then instructed to answer the questions that related to audio & video materials. the rest of the questionnaire was answered by participants themselves. in order to ensure the quality of data, questionnaires with more than % of items unanswered were considered ineligible and removed before analysis. epi data . was used for data double entry and spss . for data analysis. descriptive statistics were employed to examine demographic characteristics. anova was applied to compare the differences among social demographic groups and the student-newman-keuls method was used to control the total α level. scale and factor analyses were conducted to verify the scale's reliability and construct validity. confirmatory factor analysis of a half randomly selected sample was implemented by the statistical analysis system (sas, version . ). path analysis was also implemented by sas. covariance analysis of linear structural equations (calis) was performed to examine the model. furthermore, maximum likelihood estimation was used to appraise the parameters with the covariance matrix. the path model was modified for several times until the main indexes of goodness of fit implied the final model fit the data well. generally, the α level was set at . . initial eigenvalue > was the criterion in the factor analysis. among respondents, . % of them were male and . % of them were female. the range of age was from to years and the average age was . ± . . the majority ( . %) of the respondents ware the han nationality. as for the marriage status, the proportions of single, married and other status were . %, . %, and . %, respectively. occupations of the respondents distributed across a number of fields, such as worker ( . %), service provider ( . %), office worker ( . %), farmer ( . %), retired ( . %) and others(including students, scientific and technical workers, teachers and doctors) ( . %). table shows other social demographic characteristics. table also shows the differences among age groups, education levels and income levels on prior knowledge about infectious respiratory diseases, health literacy, health behavior and health status. prior knowledge score and health literacy score increased as education levels and income rose, but tended to decline with increasing age. health behavior scores increased with higher levels of education and health status scores increase slightly with age. the effect of age on prior knowledge and health behavior had no linear trend. as seen in table , the correlations between demographic characteristics and various scores reflected the same characteristic with table . as for scores of prior knowledge, health literacy, health behavior, the correlations between each other were strong, while health status only has slightly strong correlation with health behavior. based on the proposed model on figure , a path model was tested and validated, seen as figure shows the determinants of health literacy and its effect on health behavior, even the relationship between health behavior and health status. the bold arrows show the strong effects among variables, especially "education", "prior knowledge", "health literacy" and "health behavior". education is the most important factor. it strongly and directly affects both prior knowledge and health literacy. the higher the level of education, the higher one tends to score in terms of prior knowledge and health literacy. prior knowledge is slightly affected by income, with those earning higher incomes possessing greater prior knowledge. health literacy is also affected by prior knowledge and age; the effect from prior knowledge is positive and that from increasing age note: ns, no significant difference; *, p < . ; **, p < . ; ***, p < . . the student-newman-keuls method was used to control the total α level. there were significant differences between §, †, ‡ and # groups, but no significant differences within each group. is negative. health literacy is a direct influencing factor of health behavior, but its effect is weaker than that of prior knowledge. the strongest influence factor for health status is age. with increasing age, health status is better. health behavior and health status have an interactional relationship, and the role of health behavior on health status is a little greater than that of health status on health behavior. this study established and validated a health literacy model at the individual level. this model included sociodemographic characteristics, prior knowledge, health literacy, health behavior and health status. it is a simple empirical model rather than a complicated conceptual model. in the model, socio-demographic characteristics are the basic factors. in this research, a number of sociodemographic factors were tested, such as gender, ethnicity, marital status, and occupation. there was no significant difference between genders and ethnic groups when it came to measurements of health literacy. the main reason is that the awareness of the public on the prevention of infectious respiratory disease has been greatly increased with various intervention activities being conducted after the outbreak of severe acute respiratory syndromes (sars) in and the outbreak of highly pathogenic avian influenza in in china. there was, however, a significant difference between the unmarried and married group, but the difference is explainable by age differences. in addition, there was a significant difference in health literacy across three categories of occupation. highest health literacy scores were seen among students, scientific and technical workers, teachers and doctors. office workers, service providers, general workers and other workers scored lower, while farmers and retired people scored lower still. due to the strong relationship between education level and subsequent occupation, the effect of occupation on health literacy reflected the effect of education on health literacy in a similar fashion. therefore, the model incorporated only three important factors: age, education and income. undoubtedly, educational background is the most important factor. in a structural equation, the coefficient of education background on health literacy was . , which indicates that with each level of education (classified as primary school, junior high school, senior high school, college and graduate students), participants score almost . points more in the health literacy test, which is roughly equivalent to understanding eight percent more health information in daily life. this indicates how important education is for the promotion of health literacy. education has the same strong effect on prior knowledge, and a further indirect effect on health literacy though prior knowledge. as an important social source of information, the effect of higher education levels on health literacy has been demonstrated in many studies [ , ] . in this study, we confirmed the quantitative relationship between education and health literacy, and the standardized coefficient (β)was . almost same with cho's study (β = . ) [ ] . age is the second important factor. through careful measurement, we find that prior knowledge and health literacy tend to increase slightly among younger age groups, but then decrease significantly with age among the older age groups. therefore, targeting the under- age group for the popularization and publicity of health literacy programwhen perception and behavior form and develop stablycan promote their health skills and knowledge, bringing them lifetime benefits. for those aged over , health communication and health education must be consolidated due to the downward trend of knowledge and health literacy with aging. conversely, the study found older age groups' health status was better than that of the younger groups, with the - age group as the dividing point. this finding is contrary to what other studies have measured. the main reason for this is that the health status category was only concerned with the frequency an individual got a cold and the severity of such sicknesses because it is relatively easier and more feasible to measure the frequency of catching a cold and its severity than other kinds of infectious respiratory diseases. as we know, older people have often developed stronger resistance to these illnesses than younger people. for example, kumar's review of h n flu shows that the virus is causing critical illnesses mostly in young adults. the researchers concluded that h n (swine flu) primarily affects young adults who are in relatively good health and free of underlying illnesses [ ] . income is the weakest of the three influencing factors in this study. it has only a slight effect on prior knowledge. usually, those of higher individual incomes own more sources of knowledge. therefore, the measured negative effect of income on health behavior is an unexpected phenomenon, though the standardized coefficient is very little and the t value of − . is only just significant. therefore, the relationship between income and prior health knowledge needs further research to confirm. in this study, prior knowledge is defined as an individual's knowledge at the time before reading, watching or listening to the health-related materials. baker's article cited the report of the institute of medicine's expert panel, and gave a more expansive definition of health literacy which included conceptual knowledge as part of health literacy [ ] . however, more researchers view conceptual knowledge or prior knowledge as a resource or a moderator that a person has, which facilitates health literacy, but does not in itself constitute health literacy [ , , , ] . this study finds that prior knowledge has a strong direct effect on health literacy. that is to say that a person with more health knowledge is better able to obtain, comprehend and use health information. in the model, we confirmed that health literacy and prior knowledge are the top two determinants of health behavior. prior knowledge's effect on health behavior stands to reason, for example in the kap model [ ] . health behavior and health status are interactional. in baker's model, health literacy is one of many factors that lead to the acquisition of new knowledge, more positive attitudes, greater self-efficacy, positive health behaviors, and better health outcomes [ ] . in von wagner's model, health outcomes depend on a range of mediating processes, most obviously actions to promote health, prevent disease, or comply with diagnosis and treatment, which the author calls health actions [ ] . in paasche-orlow and wolf's model, they proposed causal pathways between limited health literacy and health outcomes [ ] . their models distinguish three different types of health actions that mediate the impact of health literacy on health: access to and utilization of health care, patient-provider interaction, and self-care. in this study, health behavior mainly focused on self-care and utilization of health care, while health status reflected health outcome. however, health behavior and health status did not show a good relationship. the measurement of health status in this study was conditioned to respiratory infection due to the restriction of the project scope. it is obvious that respiratory infections are influenced by many things, not only individual behavior, but also a variety of biological and social factors. therefore, the relationship between health behavior and health outcomes, and the effect of health literacy on health outcomes though health behavior need further study to validate. this model explains the determinants of health literacy and the associations between health literacy and health behaviors well. education has positive, strong and direct effect on prior knowledge and health literacy. health literacy is also affected by prior knowledge and age, the effect from prior knowledge is positive and that from age is negative. health literacy is a direct influencing factor of health behavior. the most important factor of health status is age. health behavior and health status have a positive interaction effect. in this study, we focus on a health literacy model at the individual level. we should also try to highlight the importance of future research to extend the scope of health literacy beyond the individual. the research indicates that medical knowledge and health literacy are the main determinants of health behavior and health status, so health educators and health care providers should focus on developing culturally sensitive educational materials using a variety of media. increased staffing of health educators in clinical settings and community interventions would also help increase health literacy. we would like to develop an intervention that demonstrates how health literacy can be addressed to target community outcomes as opposed to individual outcomes. it is also important for this model to be testedand likely revisedso that intervention strategies to mitigate the impact of low health literacy are informed and conceptually driven. limited by the project's background, this study only measures health literacy where it concerns infectious respiratory diseases. therefore, the feasibility of the model should be tested in regards to other diseases and aspects of health. the study, participated in its design and coordination. all authors read and approved the final manuscript. introduction, in national library of medicine current bibliographies in medicine:health literacy health literacy: what is it? new directions in research on public health and health literacy the 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integrated model of health literacy using diabetes as an exemplar the development of health literacy in patients with a long-term health condition: the health literacy pathway model education, literacy, and health: mediating effects on hypertension knowledge and control the meaning and the measure of health literacy the causal pathways linking health literacy to health outcomes health literacy and health actions: a review and a framework from health psychology what is health literacy and how do we measure it the health literacy of america' s adults: results from the measuring health literacy: a pilot study of a new skills-based instrument survey on the status of health literacy of chinese residents in critically ill patients with influenza a(h n ) infection in canada health literacy, social support, and health: a research agenda an experimental evaluation of the kap model for he submit your next manuscript to biomed central and take full advantage of: • convenient online submission • thorough peer review • no space constraints or color figure charges • immediate publication on acceptance • inclusion in pubmed, cas, scopus and google scholar • research which is freely available for redistribution this study was funded by china-us collaborative program on emerging and re-emerging infectious diseases ( u gghh - ). we would like to acknowledge the cdc china office and rti international for their support and valuable comments. we also thank all health care workers in beijing, shenzhen and datong for their help in data collection. we have no competing interests.authors' contributions xs participated in the design of the study, performed the statistical analysis and involved in drafting the manuscript. ys participated in the fieldwork of the study and interpretation of data. qz participated in the fieldwork of the study and analysis of data. yw participated in the fieldwork and involved in revising the manuscript. wd made contributions to design and participated in the fieldwork. nw conceived of the study and participated in its design. rx conceived of the study and participated in its design. cc conceived of key: cord- -hmii bvq authors: gostin, lawrence o.; friedman, eric a. title: health inequalities date: - - journal: hastings cent rep doi: . /hast. sha: doc_id: cord_uid: hmii bvq health inequalities are embedded in a complex array of social, political, and economic inequalities. responding to health inequalities will require systematic action targeting all the underlying (“upstream”) social determinants that powerfully affect health and well‐being. systemic inequalities are a major reason for the rise of modern populism that has deeply divided polities and infected politics, perhaps nowhere more so than in the united states. concerted action to mitigate shocking levels of inequality could be a powerful antidote to nationalist populism. a basic yet critical start to addressing health inequalities is to recognize them, which demands improving data collection and analysis. certainly, global indicators show vast progress in reducing poverty and extending life. yet aggregate health data mask a deeper reality: health gains have disproportionately benefited the well‐off, leaving the poor and middle‐class behind. t he perceived injustice of the hoarding of global wealth ( percent of it in ) by the top percent of individuals has driven both left-and right-wing political populism that is deeply suspicious of globalism, trade liberalization, and corporate wealth and influence. wealth, though, is hardly the only area where vast inequalities are manifest. socioeconomic position is also a core determinant of whether a person will be able to live a long and healthy life. health inequalities are embedded in a complex array of social, political, and economic inequalities-as the covid- pandemic is making glaringly evident. responding to health inequalities will require systematic action targeting all the underlying ("upstream") social determinants that powerfully affect health and well-being. systemic inequalities are a major reason for the rise of modern populism that has deeply divided polities and infected politics, perhaps nowhere more so than in the united states. concerted action to mitigate shocking levels of inequality could be a powerful antidote to nationalist populism. a basic yet critical start to addressing health inequalities is to recognize them, which demands improving data collection and analysis so that overall improvements in health do not disguise the dark reality of health inequalities. certainly, global indicators show vast progress in reducing poverty and ex-tending life. (the united states is an outlier, as average life expectancy ticked down three years running, mostly due to "diseases of despair," such as opioid overdoses and suicides, until edging upward in . ) globally, deaths of children under five, maternal deaths, and deaths from infectious diseases (like hiv/aids, tuberculosis, and malaria) have all been trending down for years. yet aggregate health data mask a deeper reality: health gains have disproportionately benefited the well-off, leaving the poor and middle-class behind. a baby born in a largely white, wealthy suburb of st. louis can expect to live thirty-five years longer than one born in a mostly black, lower-income suburb a few miles away. average life expectancy among black south africans is sixteen years lower than for whites. while people in japan and switzerland live an average of eighty-four years (monaco's life expectancy is eightysix ), those in the central african republic and lesotho average fiftytwo and fifty-three years, respectively, and those in chad, sierra leone, and nigeria, fifty-four. (the united states ranks twenty-sixth among organisation for economic co-operation and development countries, near the bottom, with an average of seventy-nine years. ) the circumstances of your life-where you are born, your identity, your socioeconomic position-are the greatest predictors of your future. most health gains align with the united nations millennium development goals (mdgs), which used aggregate measures of progress, thereby concealing grossly inequitable distribution. within countries, the wealthier percent of populations saw rapid reductions in hiv, for example, while the poorer percent made few gains. in paraguay, the indigenous aché people have a tuberculosis incidence seventy-five times that of the country's population overall, while tb incidence among canada's indigenous inuit people is over three hundred times that of nonnative canadians. in low-and middle-income countries, percent of communities have seen lower child mortality, but one study found that in one-quarter of sixty-four countries surveyed, the poorer percent of the population were experiencing worse mdg health outcomes as the mdg period progressed. persistent opportunity gaps mean that more than half the world's population lacks access to essential health services. in new york city, maternal deaths of black women are twelve times higher than those of white women. and even early covid- data has made clear that black americans are becoming infected and dying at considerably higher rates than white americans are. at the current rate, many countries will not close core health equity gaps this century, much less achieve the u.n.'s sustainable development agenda's pledge that "no one will be left behind" by . public discontent with these alarming health disparities is palpable. much of the anger is directed toward the very rich-the top percent-and at "greedy" corporations, especially those selling health products and services, like pharmaceutical companies and health insurers. as the costs of essential medicines and health insurance inextricably at law health inequalities by lawrence o. gostin and eric a. friedman rise, the public perceives that profit trumps health. there can be little doubt that the richest percent and mega corporations leverage their influence to gain advantage, such as lower taxes and lax regulation. we're seeing a race to the bottom, with corporations of all sorts seeking the lowest tax and weakest regulation destinations. transnational corporations are not paying their fair share for the social safety net (including health costs), and they evade more rigorous health, safety, and environmental regulations-all of which threatens people's health. in essence, this is the populist claim: advantages are going to the wealthy and bypassing middle-and lower-income people. undoubtedly, this narrative rings true, but there are other deeply consequential reasons for health inequalities. we can't fix what we don't measure t he u.s. gross domestic product was up for ten straight years before covid- , but economists were seeing a disconnect between rosy economic indicators and deep social discontent. the public is not wrong in feeling despair; the fault is with the data. the gdp is a measure of aggregate national economic growth, but wealth growth most benefits the top percent. at least before the economic ramifications of covid- , upper-income families had more wealth than they did before the great recession, while middle-and lower-income families remained well below prerecession ( ) levels, and the wealth of middle-and lower-income families is sure to fall further due to the pandemic. a new indicator, distributional accounts, would show how much of the economy's bounty is flowing to various income groups. the failure to gather, analyze, and disseminate the most pertinent data also hampers understanding of health disparities. with limited exceptions, statisticians measure overall health outcomes, so we have too little understanding of who is left behind, where they live, and why they suffer disproportionate health burdens. most importantly, if policy-makers are blithely unaware of health inequities, they are unlikely to do anything about them. thus, the first step in addressing health inequities is to measure them. by all means, continue aggregate assessments of the health of the nation, but also rigorously examine granulated data to understand better the stark variances in health outcomes. it's about public health and social determinants w hen discussing solutions to problems of health and equity, the political class almost invariably talks about health care and, specifically, about how to achieve universal health coverage. the democratic primaries feature outsized debates on "medicare for all," while tedros ghebreyesus, director-general of the world health organization, says, "all paths lead to universal health coverage." yet, as important as medical services are, they are not particularly strong drivers of population health. the more consequential health services by far are population-based public health interventions like sanitation, potable water, safe nutritious food, vector abatement, and alcohol and tobacco control. and public health measurements do not track visits to doctors or hospitals but, rather, the incidence and prevalence of injuries and diseases in the population. less than percent of all health dollars in the united states flow to public health, with the rest invested in medical and hospital services. if you ask any epidemiologist what the single biggest predictor of health outcomes is, she would point to social determinants outside the health sector, including employment, education, housing, and transportation. yet while a physician can, for example, counsel an asthmatic patient to avoid environmental triggers, if the patient lives in a neighborhood replete with indoor and outdoor pollution, or if she is homeless, no amount of medical care will prevent wheezing and breathing difficulties. deeply rooted structural factors, such as low social status or racism, are causally related to poor health. scholars observe that a history of racial segregation adversely affects health outcomes for african americans across generations. the remedies for health inequities are therefore complex, requiring action across sectors, including access to justice. intersectoral collaboration and action require new mindsets across government agencies. yet the data we collect do not account for systemic structural factors. without explicit attention to them, little progress will be made. a s important as health and economic equity are, they offer only a partial explanation for populism's rise. the united states appears separated by social class, education, and geography. working-class rural inhabitants feel that the wealthy, professional classes in the city look down at them. and many of these well-off city dwellers may, in fact, not understand concerns from the heartland; some might not even genuinely listen to them. in short, the polity feels that it is told that it must trust people they see as "the other," those who seem very different culturally and politically. voting for a plain-speaking, even vulgar and dishonest populist leader is, in part, a rebellion against a feeling of being neglected, even disrespected. and, as many rural americans see their communities becoming more diverse and see cultural norms shifting, some respond by turning to politicians who exploit their fears, and even their prejudices. there are also tangible realities undermining health and well-being in rural america. rural americans struggle to find well-paying jobs, quality education, and health services. small towns suffer the loss of the many educated young people who migrate to cities. in many communities, affordable health insurance is scarce, qualified health workers either leave or never come, and hospitals are closing. and many rural populations live in states that haven't expanded medicaid under the affordable care act, thus blocking health care access for the working poor. a combination of low socioeconomic status and a diminishing social safety net is driving deep systemic inequalities in health. the sense among less-educated, rural voters of being disrespected contributed to president trump's election in . however, he has cut supplemental nutrition assistance program benefits, undermined the affordable care act, and allowed work requirements for medicaid coverageactions that contribute to health inequalities and harm many of the very people who voted for him. just recently, the supreme court allowed the trump administration's "public charge" rule to take effect even as challenges to the rule continue to work their way through the courts. the rule is a major obstacle for legal immigrants who require public assistance, including medicaid, housing vouchers, and food stamps, and will cause many of these people to go without vital support. what can we do now? i f we want to fix health inequalities, we must focus on them. equity solutions require dedicated, sustained, prioritized, and well-resourced plans, which we call "health equity programs of action." programs of action would be systematic and systemic and would include explicit targets, costed actions, rigorous measurement, and accountability through a comprehensive national effort. every country could benefit. the united states could choose to lead, which would be a powerful political commitment to health equity and justice. the sustainable development agenda's pledge to leave no one behind will surely go unfulfilled unless we act decisively. with inequities causing millions of preventable deaths globally every year, offending the deepest values of fairness, there is no time to lose. it would be a grave injustice to see approaching and, yet again, find the world has failed to dramatically reduce health inequalities. and if we succeed, an intangible yet powerful benefit will be to restore a sense of dignity for all of society and, in turn, act collectively to elect truthful, compassionate leaders who bring us together as a nation. richest % own half the world's wealth, study finds american life expectancy rises for first time in four years forward through ferguson: a path toward racial equity (stl positive change, ferguson commission life expectancy at birth, total (years) united health foundation progress on global health goals: are the poor being left behind? us-china trade war imperils efforts to beat poverty, warns bill gates easing the dangers of childbirth for black women putting health equity at heart of universal coverage-the need for national programmes of action how wealth inequality has changed in the u.s. since the great recession, by race, ethnicity and income public health's falling share of u.s. health spending on charlottesville putting health equity at heart of universal coverage key: cord- -tny bn authors: watkins, johnathan; wulaningsih, wahyu title: three further ways that the covid- pandemic will affect health outcomes date: - - journal: int j public health doi: . /s - - - sha: doc_id: cord_uid: tny bn nan the covid- pandemic represents an unprecedented challenge. policy makers, the medical and research community, as well as the wider public have rightly focussed on the deaths caused by the virus. however, we believe there are three further ways in which this pandemic will affect mortality rates around the world. first, there is the likely mortality rise during the pandemic as health system resources are diverted to helping covid- patients. interruptions to planned care (e.g. for cancer) and even to non-elective care are likely to cause a modest but significant spike in non-covid- -related deaths. for example, one study showed that most head and neck cancers double in size within - months (jensen et al. ). delays to screening or management are likely to generate a much higher caseload of late-stage disease. second, there is the effect of the ensuing recession, characterised by potentially record levels of unemployment in many countries. in general, health outcomes improve during recessions, mostly driven by fewer cardiovascularrelated deaths possibly as a result of more active lifestyles (strumpf et al. ). on the other hand, some disease outcomes worsen, such as suicides (reeves et al. ) and treatable cancers in countries without universal health coverage (maruthappu et al. ) . in this recession though, the pandemic-enforced home isolation could mean that the aforementioned cardiovascular benefits do not materialise, leading to a net rise in mortality rates. finally, there is the consequence of the economic response. if countries respond with austerity measures that lead to a real-terms decline in public health and social care spending, we could see hundreds of thousands of 'excess' deaths or more. our work and that of others have shown that reducing spending without gains in health system efficiency is associated with poor outcomes across all disease areas (watkins et al. ) . to mitigate the negative effects of the first and second points, governments should start defining strategies on when and how to safely exit from lockdown measures as soon as possible. health system capacity along with the number of new cases and hospitalisations over time, and the emergence of new pharmaceutical interventions are critical inputs to an exit strategy. there are at least three benefits to making plans for an exit strategy now. first, it returns focus on the system capacity measures and pharmaceutical interventions that can save lives independent of non-pharmaceutical demand management measures. second, it gives visibility to government departments and other organisations on what needs to be put into place for a successful recovery once measures are lifted. finally, it generates public confidence in policy makers possibly improving adherence to ongoing demand management measures. to address the economic response challenge, governments need to be prepared to maintain health and care spending in line with demand. avoiding austerity through increased borrowing or reallocating of budgets is merely a couple of the mechanisms by which such spending objectives could be achieved. in summary, therefore, the number of lives lost due to covid- has the potential to be dwarfed by the number of lives lost as a result of these three knock-on effects of the pandemic. governments can prevent or mitigate this effect by: ( ) planning and communicating an exit strategy early to avoid needlessly protracted lockdowns and/or illprepared exits and ( ) seeking to maintain public health and social care spending levels. tumor progression in waiting time for radiotherapy in head and neck cancer economic downturns, universal health coverage, and cancer mortality in high-income and middle-income countries, - : a longitudinal analysis increase in state suicide rates in the usa during economic recession did the great recession affect mortality rates in the metropolitan united states? effects on mortality by age, gender and cause of death effects of health and social care spending constraints on mortality in england: a time trend analysis conflict of interest the authors declare no conflicts of interest. key: cord- -x yrnnux authors: wu, qiwei l.; street, richard l. title: factors affecting cancer patients’ electronic communication with providers: implications for covid- induced transitions to telehealth date: - - journal: patient educ couns doi: . /j.pec. . . sha: doc_id: cord_uid: x yrnnux objective: because of the pandemic, electronic communication between patients and clinicians has taken on increasing significance in the delivery of cancer care. the study explored personal, clinical, and technology factors predicting cancer survivors’ electronic communication with clinicians. methods: data for this investigation came from the health information national trends survey (hints , cycle ) that included respondents who previously or currently had cancer. multivariate regression analyses were used to predict electronic communication with clinicians. predictors included demographic variables and health status, technology use (online health information-seeking behavior, tracking of health-related data such as using a fitbit), and quality of past communication experiences with clinicians. results: in this pre covid- sample, % respondents (n = ) did not engage in any type of electronic communication (e.g., emailing, texting, data sharing) with providers. in multivariate analyses, predictors of more electronic communication with clinicians included frequency of seeking health-related information online (ß = . , p < . ) and better communication experiences with clinicians (ß = . , p = . ), while no demographic variable showed significance. the technology use variables (online health information seeking, health tracking) were significantly higher predictors of electronic communication with clinicians (Δr( ) = . , p < . ) than was past experiences with clinicians (Δr( ) = . , p = . ). conclusions: access and past experience with interactive media technologies are strong predictors of cancer patients’ electronic communication than with clinicians. adoption of telehealth technology likely depends as much on patients’ relationships with technology as it does their relationships with clinicians. practice implications: since covid- , cancer care providers have turned to telehealth provide patients with needed cancer care services. enhancing patients’ digital competence and experience with electronic communication will help them more easily navigate telehealth care. providers can leverage their relationship with patients to facilitate more effective use of telehealth services. public's use of cancer-related information and changing communication trends and practices, including their e-communication with clinicians. although pre covid- , this survey does allow for an examination of factors associated with cancer survivors' willingness to engage in e-communication with clinicians via secure messaging, emailing, and data sharing. while hints does not address synchronous telehealth visits per se, these forms of e-communication (e.g., patient portals, text messages) have become even more important since the pandemic so that patients can access information, lab results, support resources, and have interactions with clinicians [ , , ] . in order to identify factors affecting patients' willingness to use e-communication with cancer care providers, this investigation embraces a key premise of social cognitive theory (sct) [ ] that posits that an individual's behavior is a function of personal factors and environmental influences. given past research, we expect personal characteristics (e.g., higher education, health status, younger age) may influence one's e-communication with providers [ , ] . cancer patients' interactions with their environments would include their relationships with health care providers as well as their relationships with technology. some research indicates each may independently influence e-communication with clinicians [ , ] . guided by sct, this investigation examined the following research question: rq: to what extent do cancer patients' demographic and health-related characteristics, past health care experiences (frequency of seeing providers, quality of communication), and use of technology for health-related purposes (seeking online health information, using health tracking devices such as fitbit) predict their utilization of e-communication with providers? j o u r n a l p r e -p r o o f we used the hints data, a nationally representative mail survey gathered in the us from january to may , and included respondents who had a previous cancer diagnosis. table shows the study variables and how they were measured. the outcome variable, e-communication with clinicians, was the sum of whether in the past year respondents had texted, emailed, and/or electronically shared information with a health care provider (scale range - ). to answer the research question, predictor variables were grouped into categories based on the premises of sct-(a) personal and health-related (age, education, race/ethnicity, gender, time since cancer diagnoses, physical and mental health status), (b) past experiences with health care providers (how many visits with providers over past months, quality of past communication experiences), and (c) use of technology for health-related purposes (using the internet to seek health information, using technology to track health data). regression analyses were conducted in three blocks using the grouped variables. first, demographic and health variables were entered into the model (model ), followed by variables related to past experiences with providers (model ), and finally use of technology for health purposes (model ). to assess significance in variances explained, we observed the r-squared change in models and . j o u r n a l p r e -p r o o f most participants were females (n = , %) and reported good to excellent physical (n = , . %) and mental health (n = , . %) ( table ) . education levels varied, and time since cancer first diagnosed cancer ranged from to years (m = . , sd = . ). approximately % respondents (n = ) had not engaged in any e-communication with providers. in bivariate analyses, e-communication was higher among the younger (r = -. , p < . ) and more educated respondents (r = . , p < . ), as well as those who more often sought health information online (r = . , p < . ), tracked health data (r = . , p < . ), and who visited providers more often over the last months (r = . , p < . ). in multivariate analysis, demographic and health factors (model ) explained . table for full regression results). j o u r n a l p r e -p r o o f had some positive experiences using telehealth services, including saving personal protective equipment (ppe) and reducing the need for hospital services [ ] . other evidence indicates that telehealth has not increased physicians' workload and that both cancer patients and providers have expressed satisfaction with transitions to telehealth for certain services [ ] . recent surveys in various countries suggests that, while many patients still prefer in-person visits for some aspects of care, telehealth platforms offer a reasonable and satisfactory alternative for other cancer care services [ , , ] . however, successful transitioning to telehealth for cancer care services will depend on patients' willingness and capacity to use digital forms of communication with their providers. based on our findings, the quality of patients' relationships with clinicians and their experiences with using technology for health-related purposes will be important determinants. this study has limitations. our analysis was exploratory, and we did not examine patients' use of telehealth visits during covid- . attitudes toward live telehealth visits were not assessed by hints, and factors affecting real-time virtual visits may be different from asynchronous e-communication. also, as a cross-sectional survey, hints allows for identifying correlations among variables and not necessarily causation. finally, hints did not query respondents' access to and quality of internet connectivity, which greatly affects one's experiences using telehealth. the most important implication of our findings is that the transition from face-to-face to telehealth consultations involves more than simply adapting to a different medium for clinical encounters; it also depends on users' (both patients and clinicians) relationships with interactive j o u r n a l p r e -p r o o f media technology. just as medical care transitioned from the biomedical model to the biopsychosocial model of clinical care [ ] , health communication researchers need to think beyond the body, mind, and social dimensions of health to also include the technological context of health-related experiences. our study suggests that cancer patients' relationships with technology for health-related purposes, along with their relationships with clinicians, are key components for successfully engaging cancer patients with telehealth. there are at least two ways health care providers can help patients more smoothly transition to telehealth for some cancer care services. first, clinicians can develop strategies to promote and maintain effective clinician-patient communication when using digital platforms. these include proactively using the technology to reach out to patients to stay connected, taking steps to offering longer time during virtual visits, and finding ways to maintain the humanness of supportive relationships [ ] . second, transitioning to telehealth has been a learning curve for both providers and patients. in light of pre-covid research showing that most patients do not discuss their use of health information technology (e.g., use of the internet for health information) with their providers [ ] , clinicians could initiate conversations on this subject to guide patients' use of telehealth, address any concerns around its use, and assist patients in navigating various digital functions (e.g., online consultations, examinations, data sharing) afforded by virtual platforms [ ] . the importance of having positive initial telehealth visits was shown in a recent study [ ] note. ** correlation is significant at the . level ( -tailed), * correlation is significant at the . level ( -tailed) j o u r n a l p r e -p r o o f telehealth transformation: covid- and the rise of virtual care rapid utilization of telehealth in a comprehensive cancer center as a response to covid- : cross-sectional analysis oncology practice during the covid- pandemic patients' satisfaction with and preference for telehealth visits an evaluation of patient-physician communication style during telemedicine consultations specialist-primary care provider-patient communication in telemedical consultations revisiting effective communication between patients and physicians: cross-sectional questionnaire study comparing text-based electronic versus face-to-face communication e-mail in patient-provider communication: a systematic review effective health communication-a key factor in fighting the covid- pandemic innovative use of patient portals during cancer survivorship: a first step optimizing the communication with cancer patients during the covid- pandemic: patient perspectives health promotion by social cognitive means a systematic review of unmet needs of newly diagnosed older cancer patients undergoing active cancer treatment verdonck-de leeuw, cancer survivors' perceived need for supportive care and their attitude towards selfmanagement and ehealth factors influencing communication with doctors via the internet: a -sectional analysis of hints survey the association of patient factors, digital access, and online behavior on sustained patient portal use: a prospective cohort of enrolled users barriers and facilitators to online portal use among patients and caregivers in a safety net health care system: a qualitative study i want to keep the personal relationship with my doctor": understanding barriers to portal use among african americans and latinos patient-provider communication and trust in relation to use of an online patient portal among diabetes patients: the diabetes and aging study use of telemedicine and virtual care for remote treatment in response to covid- pandemic a practical approach to the management of cancer patients during the novel coronavirus disease (covid- ) pandemic: an international collaborative group telemedicine for cancer patients during covid- pandemic: between threats and opportunities telemedicine during the covid- pandemic: impact on care for rare cancers telehealth in uro-oncology beyond the pandemic: toll or lifesaver? telemedicine for head and neck ambulatory visits during covid- : evaluating usability and patient satisfaction the clinical application of the biopsychosocial model maintaining patient relationships in the age of hospitalists, urgent care, and a pandemic communication about health information technology use between patients and providers use of expectation disconfirmation theory to test patient satisfaction with asynchronous telemedicine for diabetic retinopathy detection an ultra-brief screening scale for anxiety and depression: the phq- patient-centered communication in cancer care: promoting healing and reducing suffering key: cord- - wqpvf authors: chiu, hsiao-hsuan; hsieh, jui-wei; wu, yi-chun; chou, jih-haw; chang, feng-yee title: building core capacities at the designated points of entry according to the international health regulations : a review of the progress and prospects in taiwan date: - - journal: glob health action doi: . /gha.v . sha: doc_id: cord_uid: wqpvf background: as designated points of entry (poes) play a critical role in preventing the transmission of international public health risks, huge efforts have been invested in taiwan to improve the core capacities specified in the international health regulations (ihr ). this article reviews how taiwan strengthened the core capacities at the taoyuan international airport (tia) and the port of kaohsiung (pok) by applying a new, practicable model. design: an ihr poe program was initiated for implementing the ihr core capacities at designated poes. the main methods of this program were ) identifying the designated poes according to the pre-determined criteria, ) identifying the competent authority for each health measure, ) building a close collaborative relationship between stakeholders from the central and poe level, ) designing three stages of systematic assessment using the assessment tool published by the world health organization (who), and ) undertaking action plans targeting the gaps identified by the assessments. results: results of the self-assessment, preliminary external assessment, and follow-up external assessment revealed a continuous progressive trend at the tia ( , , and %, respectively), and at the pok ( , , and . %, respectively). the results of the follow-up external assessment indicated that both these designated poes already conformed to the ihr requirements. these achievements were highly associated with strong collaboration, continuous empowerment, efficient resource integration, and sustained commitments. conclusions: considering that many countries had requested for an extension on the deadline to fulfill the ihr core capacity requirements, taiwan's experiences can be a source of learning for countries striving to fully implement these requirements. further, in order to broaden the scope of public health protection into promoting global security, taiwan will keep its commitments on multisectoral cooperation, human resource capacity building, and maintaining routine and emergency capacities. t aiwan, an island situated in the subtropical zone, economically relies on international trade and has long been aware about preventing the import of communicable diseases through the thriving international traffic. the point of entry (poe) plays a critical role for early detection of disease risks and the mitigation of the impact of the rapid spread of infections. therefore, border health measures have been applied at all international airports and seaports by the taiwan centers for disease control (tcdc). however, the emergence of new import infections urged taiwan to ensure the capability of responding to the pandemic at poes. as it has always been a challenge to ensure prompt mobilization of various stakeholders at poes for jointly battling a threat of an epidemic, tcdc invested substantial efforts to seek a systematic and focused approach that can develop poe capacities with the strong collaboration of stakeholders. meanwhile, as the severe acute respiratory syndrome (sars) epidemic had challenged the traditional rationale of global health protection ( Á ), the international health regulations (ihr) were revised and formally approved by the th world health assembly (wha) in (therefore called international health regulations ; ihr ) ( ). the new regulations require state parties to enhance and monitor eight national core capacities. in addition, it also extends its scope by including the responsibility to respond to zoonotic, food safety, chemical, and radiological hazards ( ) . the intent is to assist countries in focusing their efforts on the improvement of the detection, control, and response to international public health emergencies at their sources. taiwan spared no efforts in conforming to the ihr provisions and announced the willingness to implement them year ahead of schedule. thus, before the ihr was officially enforced on june , , taiwan had coordinated relevant government authorities to adopt the ihr provisions into domestic legislations, specifically in acts such as the 'communicable disease control act' and 'regulations governing quarantine at ports'. the amended legislations, which were regarded as the foundation of fulfilling ihr requirements, combined the goals and measures to be implemented in taiwan, with the emphasis on the improvement of capacities in detecting, assessing, notifying, and responding to public health threats. in the ihr , the provisions for poes have been designed to minimize public health risks caused by the spread of diseases through international traffic ( ) . based on the requirements stated in the regulations, the state party need to designate specific poes, to develop the capacities listed in annex b of the ihr . in , the world health organization (who) published an assessment tool for core capacity requirements at designated airports, ports and ground crossings ( ) . in this tool, the capacity requirements have been transformed into assessing indicators, which enable state parties to identify existing capacities or potential gaps, along with the formulation of plans of action that address the capacities that need to be improved, by assessing the stage of implementation. the assessing indicators can be separated into three parts: ) part a: communication and coordination framework among various stakeholders, ) part bi: capacities necessary at all times (called routine capacities), and ) part bii: responding to public health events of international concern (pheic, also called emergencies). right after the tcdc learned that the who assessment tool was published, the institute found that poe requirements listed in the tool highly echoed its continuous anticipation of improving taiwanese poes' own capacities in routine preparedness and effective response to health emergencies, in a manner that avoids the unnecessary interference with international travel and trade. therefore, the who assessment tool seemed very helpful in this context because it provided a concrete framework for taiwan to identify the capacities to be examined, and the actions to be taken for achieving the goals. subsequently, the tcdc decided to concentrate on adopting this tool in taiwan, as soon as possible. in the absence of the who's guidance on how to adopt this tool to develop pragmatic readiness, the tcdc collected extensive information about the expertise and experiences of other countries by website and article searches ( Á ), email inquiries, and on-site visits (canada and australia). on the other hand, from their experience with previous pandemics, the global societies realized that a consistent policy based on common protocols and the cooperation between authorities at regional, national, and international levels are very critical for effective management of public health risks ( , ) . similarly, as the ihr requirements for core capacities of the poes mainly address the public health events, many additional aspects such as financial support, human resources, poe facilities, poe routine activities, and so on need to be considered while making policies and developing related protocol. it also highlights the importance of close communication and collaboration between international organizations, the central and local governments, and various competent authorities at poes ( ) . it was found that meeting ihr obligations at a poe is a universal challenge involving human resources, multisectoral engagement, and communication ( ) . further, some countries developed a crossdepartmental network/ platform, at either the central or poe level, in order to facilitate the development of these core capacities ( , ) . based on the abovementioned findings, several important conclusions were made, which includes: ) the designation of the poes should be based on consensus; ) the stakeholders with the responsibility of implementing the core capacities should be brought together, not only from the health sector, but also from other public and private sectors; ) the successful implementation of this program requires strong support from the cabinet and its subordinate organizations; ) a coordination mechanism, with clear functions and structure, is necessary; ) an agreed protocol, which clarifies the strategies, timeline, and multidisciplinary/multisectoral duties, is essential, and ) all strategies should be harmonized with the currently available resources, national administrative structure, and consensus made by the participants. in accordance with important conclusions drawn from the preparatory analysis, the tcdc submitted a protocol for a new program (called 'ihr poe program') to the executive yuan. subsequently, through extensive review and discussion, the protocol was formally approved to be implemented in january . after consulting various authorities, four criteria were taken into consideration while identifying designated hsiao-hsuan chiu et al. poes: ) the number of international conveyances, ) the number of international travelers, ) the geographical distribution, and ) the existing facilities and logistic capabilities. thus, one airport (the taoyuan international airport; tia) and one seaport (the port of kaohsiung; pok) were consensually designated at the first stage. every year, over % of the travelers enter taiwan through the tia. the airport has experienced a remarkable annual increase in the number of international travelers and aircraft during recent years, and an additional terminal is being planned. the pok, which is the largest seaport in taiwan, traditionally dealt with freight transportation. however, in the past few years, it is also being used to harbor cruise vessels and has shown a rising trend in the number of arriving travelers. in addition, a new travel center is currently being constructed. it is noted that, to upgrade competencies and promote the development of the tia and pok, during Á , the responsibility of operation and management of both the poes was shifted from the government authority to the state-run corporations. since then, these state-run corporations have been responsible for the coordination and consolidation of various agencies stationed in the designated poes, under the supervision of the ministry of transportation and communications (motc) of the central government. since the beginning of the implementation of the ihr poe program, there has been an interesting discussion on the competent authority at the designated poes. according to the ihr definition, a competent authority means 'an authority responsible for the implementation and application of ''health measures'''. originally, it was perceived that the tcdc shall serve this role. however, when the core capacity requirements were examined in detail, it was realized that some of the health measures mentioned in ihr were being conducted by other government authorities in reality. for example, if an ill traveler with symptoms of a possible communicable disease was reported in the pok, the tcdc will be responsible for the assessment of the traveler. if the tcdc decided to refer the traveler to a hospital for further diagnosis and treatment, the pok fire brigade would be responsible for transporting the traveler to the hospital (with their trained personnel and equipment). thus, in order to cater to the practical situation in taiwan, it was consensually decided that the competent authority shall vary according to the different health measures. at the poe level after the sars outbreak in , the importance of enhancing the cross-sectoral involvement through an integrated coordinative structure at poe level was highlighted. subsequently, while implementing the ihr , each poe in taiwan established a 'port sanitary group' as a network of various stakeholders. the group comprised authorities from departments responsible for customs, immigration, quarantine, security and port management, and conveyance operators, as well as the local health authorities. it has successfully served as a coordinating platform at poe level, targeted to the preparedness and the effective contingency arrangement of port health matters. during the h n pandemic in , the port sanitary group functioned very well on efficient information sharing, policy declaration, and coordination about any public health measures carried out at the poes. based on the positive coordination experiences, a specific taskforce (also called poe taskforce) was established under the port sanitary group at the tia and pok to facilitate the fulfillment of the core capacity requirements. in addition to members of the port sanitary group, this taskforce also involved private sectors such as sky catering, ground handling, and cargo terminal services. the poe taskforce coordinated with members ) to conduct core capacity self-assessment, ) to develop poe action plans that address gaps identified from the assessment, ) to monitor the progress of the action plans, and ) to provide feedback to the central governments on difficulties that have been identified regarding core capacity development. the competent authorities at the poe level in taiwan are mainly under the supervision of central governments that are in charge of national policy making, budget, and legislation. therefore, it is believed that while developing the poe core capacities, it would be more efficient if any important consensus and resource integration can be achieved in advance, at the central level, especially in terms of jurisdiction clarification and financial support. furthermore, problems that universally exist among various poes are often related to issues in general structure, which can never be resolved by the individual poes alone. in this case, problem solving must highly rely on the mobilization of resources/support from the central government to the poes. for example, initially, both tia and pok felt that they lacked the expertise/capability to cope with radiological events, or plan their response to them because the central atomic energy council commissioned no affiliated units at the poes. consequently, the council dispatched experts directly to the tia and pok, to assist them in formulating radiological emergency planning, and provided necessary training for the early detection, operation of equipment, and approach to seek external support from the national radiological response team. an inter-ministerial central government task force (also called central government taskforce) has subsequently been constituted. under the successive leadership of ministers without portfolio, ministries and agencies discussed important issues such as whether to grant poes financial support to purchase protective equipment, when to dispatch radiological/toxic chemical experts to poe to provide technical consultation. the taskforce supervised and regularly reviewed the progress of the designated poes. it can also deliver assignments and provide the poe taskforce policy-related and technical guidance (fig. ) . additionally, authorities stationed in designated poes can seek immediate assistance from their superiors at the central governments, to solve problems or to arbitrate the disagreements. for instance, the tia co. ltd, the government-owned company responsible for the operation and management of the airport, would like to clarify and improve current procedures related to security checks of postal parcels transported through the airport. therefore, apart from police and custom authorities, the company also requested its superior motc to collaborate with the national postal services (also under the supervision of motc) in the discussion. thus, the motc acted as the intermediary as well as the final decision maker (in case of any disagreements), and it was very helpful in facilitating improvement work. the ihr poe program designed three systematic assessments (self-assessment, preliminary external assessment, and follow-up external assessment), together with the implementation of action plans that addressed the identified gaps. each assessment applied the assessment indicators and scoring system provided in the who tool ( ). the self-assessment before investing resources for establishing core capacities, the poes must have an overall idea of its present status. therefore, the tia and pok had respectively completed self-assessments during march , by a poe taskforce. at the first stage, the secretariat of the taskforce led the introduction of the assessment indicators, so that members could thoroughly understand the implication of the ihr core capacity requirements. following this, members were asked to report their field activities concerning the ihr core capacities. in addition, a field visit was arranged for, if necessary. for instance, the tia taskforce visited the airport cargo terminal services to understand the operation of the transportation of dangerous goods according to international air transport association (iata) regulations. finally, members worked together to complete the who assessment tool, by describing any measures, facilities, and approaches available at the poe, and listed documents which can provide evidence on the compliance of the core capacity requirements. based on the information collected, the taskforce jointly decided the perceived stage of implementation (fully implemented, partially implemented, not implemented). the preliminary external assessment through the self-assessment, both the tia and pok obtained the baseline information of their existing core capacities, and then implemented some improvements to address the identified gaps. yet, in order to avoid bias due to subjective judgments, an external expert was invited from japan to conduct an in-depth review of the designated poes, from an international perspective, in august . during the preliminary external assessment, the reviewer carefully verified the documents that evidenced the compliance of assessment indicators. sites were visited to investigate facilities, equipment, and practices implemented in the field. in addition, the reviewer interviewed key personnel, raised inquiries, and obtained feedback during the assessment. to facilitate the assessment, a pre-designed assessment protocol was provided to the reviewer and the poes to prepare them for the same. in addition, background materials such as self-assessment reports and a brief introduction of both the poes, were provided to the reviewer in advance. the reviewer was requested to predesignate the document and the potential sites to be assessed. the follow-up external assessment in order to ensure the poe's efforts for improvement were already consistent with the ihr requirements, two experts were invited from the australia government's department of health and ageing to undertake a follow-up external assessment in mid-march . similar assessment in taiwan, a minister without portfolio refers to a minister who does not head a particular ministry. being the premier's key aides, such ministers are responsible in managing and reviewing the affairs of different government ministries and commissions, to enhance the competencies and governance quality of the cabinet. procedures (document reviews and on-site visits) were applied in the two external assessments to ensure that their results were comparable. improvement intervention on unfulfilled core capacity requirements based on findings discovered from the self and the preliminary external assessment, a series of activities were identified to improve the designated poes in taiwan. firstly, both the poe taskforces respectively prioritized the identified gaps, while taking into account factors such as urgency, resource availability, and achievability. subsequently, action plans that described practicable approaches and resource investments, and which set a defined timeline with checking points, were developed. as improvement is always a dynamic process, regular monitoring and feedback is crucial to ensure progress and that outcomes are in line with expectations. the poe taskforces were allowed to adjust the scope and timeline of the plans according to current need and performance (fig. ) . the who assessment tool also provided an ms excel spreadsheet file model, which enabled reviewers to choose their response (fully implemented, partially implemented, or not implemented) to each indicator. when the performance of each indicator is determined, the model automatically generates numerical results with graphic representations of the same. according to the who, a poe with a final score of above % is defined as fairly consistent with the requirements of the ihr annex . assessment results of the tia the tia taskforce reported a self-assessment score of %. among assessment indicators (six indicators specific to seaports/ground crossing were excluded), . % were assessed as 'fully implemented', while . % were reported to be 'partially implemented' in the airport. it was found that the tia owns a communication network among various stakeholders for communicable diseases or biological events, while the reporting system for radiological and chemical events had not yet been established. the airport exhibited routine capacities of adequate on-site medical services for ill travelers, and an inspection/surveillance program of the terminal environment and aircraft. however, the response plans toward radiological, chemical, and biological emergencies were not in place. the external reviewer of the preliminary external assessment reported that . % of the assessment indicators had been 'fully implemented', while . % had been 'partially implemented'. the total score of the tia was %, which showed a fair progress as compared to the self-assessment. from the reviewer's viewpoint, the tia had already or nearly fulfilled part a (communication & coordination) and part bi (routine) requirements, and suggested that further efforts need to be invested in developing its capabilities to respond to pheic. it was noted that all the competent authorities in the tia answered that if they encountered a problem that was difficult to address, they would consult their headquarters. however, the horizontal communication between agencies at the tia was rarely mentioned. based on the learning from the previous two assessments, the tia applied its action plans on the following areas: ) reconstructing the communication flow to ensure that event information is notified by and disseminated to stakeholders including outsourcing companies and service providers; ) formulating/updating emergency plans with the consideration of the surge response. contents of the plans, along with the communication link with various targets, were validated by table exercises or scenario drills; ) developing regular and irregular inspection mechanisms to ensure the quality of outsourcing services, and specifying all requirements in contracts; ) designating a specific location for the decontamination of pheic; ) replacing personal protective equipments (ppes) that had passed their expiry date, or purchasing required ones; and ( ) updating standard operating procedures (sops) for inspecting and responding to air postal parcels. the reviewers of the follow-up external assessment reported that % of the indicators had been 'fully implemented' (fig. ) . in general, reviewers determined five strengths of the tia: ) communication link with travelers for health-related information; ) the operation control center provides comprehensive infrastructure and management for pheic; ) on-site medical facilities and integration of resources with contracted hospitals; ) capacities for radiological and chemical inspection, and emergency response; and ) providing access to, and training in the use of, ppe for all hazards. in addition, two areas of consideration were proposed in the further implementation of the core capacities. first, as the detection of fever-screening limits for respiratory diseases was an area of concern, broader surveillance parameters may be considered to enable the detection of nonrespiratory diseases. second, it was suggested that a risk assessment may be implemented to determine whether vector control measures are warranted, and whether a response protocol should be established to mitigate the risk of introduction of vectors detected in an aircraft. in response to the reviewers' recommendations, the tcdc, as the competent authority for these matters, are carrying out policy analysis of current entry screening procedures, as well as the vector surveillance/control on aircrafts (table ) . in the self-assessment, the pok taskforce reported that . % of the assessment indicators (seven indicators were not applicable for seaports) had been 'fully implemented', . % had been 'partially implemented', while . % were evaluated as 'not implemented'. the total score of the pok was %. it was found that the communication link with senior health officials and sops for assessing urgent reports and disseminating information from the who were to be established. in addition, inspectors found a lack of knowledge about water management, swimming pool/spa, and air quality management on ships and terminal facilities. emergency planning and ppes toward radiological and chemical events were either absent or out of date, and a place had not been designated for decontamination. concerning the preliminary external assessment, the total score of the pok was %. among the assessing indicators, . % were assessed as 'fully implemented', . % as 'partially implemented', and . % as 'not implemented'. the reviewer observed that, similar to the problems identified at the tia, agencies in the pok sometimes omitted the dissemination of the information to their partners in the poes. on the other hand, since the inspection of conveyances are sometimes closely linked with the management and the inspection of the port facilities (i.e. potable water, ballast water, and waste are transported between ships and seaport), it was appreciated that the pok improved cross-sectional capacities by holding joint training programs for both ship and facility inspectors. in terms of emergencies, the reviewer perceived that the response system in the pok has been improved since the self-assessment. it was also highly valued that the pok planned 'cross-unit human resources support programs', which aimed to seek personnel belonging to other poes to support large-scale events immediately. it might help the surge capacity at the port in total. the previous two assessments provided the pok with clear clues to identify their action plan, which was as follows: ) re-examining the communication flow, taking into account private sectors such as shipping agents; ) completing the emergency response protocols toward pheic. protocols shall not only be approved by both poe stakeholders and central authorities, but also tested by drill exercises; and ) taking the ihr core capacity requirements into consideration while planning the new travel center, especially for terminal facilities such as water supply system, waste management, toilets, food/ beverage services. external reviewers of the follow-up assessment scored the pok . % (fig. ) , which implied that . % of the assessment indicators had been 'fully implemented', and . % were 'partially implemented'. it was mentioned that the sops and arrangements were in place with several hospitals for the diagnosis and treatment of ill travelers, and isolation, if required, including those affected by radiation, toxic chemicals, or explosives. it was noted that the pok disaster mitigation and prevention program had been integrated to handle chemical, microbiological, and radiological emergencies. the reviewers observed the breadth of equipment and supplies used by inspection staff trained in public health risk evaluation. however, the reviewers suggested that training courses shall be developed to address risks from recreational swimming and spa areas on ships, and systems developed for the detection, assessment, and application of the recommended measures. in addition, as a new pok travel center is underway, it was suggested that strategic workforce planning should be undertaken in anticipation of the expansion of the pok to ensure adequate staff to implement and strengthen the ihr core capacities ( table ) . based on reviewers' suggestions, the tcdc implemented inspection and control measures for recreational swimming and spa activities on ships into the annual training program for ship sanitation inspectors. in addition, the clarify the procedure of security inspection of air postal parcels. the preliminary external assessment (august ) ensure vertical consultation within competent authorities, as well as horizontal information sharing among competent authorities at poe when faced by an immediate risk. a communication exercise might be necessary, especially for events with mass casualty or high profile event. as water and food services highly rely on outsourcing companies, it might be required to review documents regularly, and to conduct direct inspection by competent authorities for monitoring the sanitation. event information should be circulated rapidly not only to public health sectors but also to the large number of service providers and outsourcing companies involved at the airport. the competent authority to be responsible for airport facilities will be expected to play a more intensive role as the control center, and it might be necessary to consider the overall appropriate 'surge capacity' of the tia. broader surveillance parameters may be considered to enable detection of non-respiratory diseases. undertake a risk assessment to determine whether expanded measures are warranted, and whether a response protocol should be established to mitigate the risk of introduction of vectors detected in aircrafts. building core capacities at the designated poes in taiwan port management authority is increasing the number of trained inspectors, and arranging for provision of training, to increase staff knowledge. in this section, we have discussed the main issues that originated from the implementation of 'ihr poe program'. results of the self-assessment, preliminary external assessment, and follow-up external assessment revealed continuously progressive trends in the tia and pok (fig. ) . the follow-up external assessment (a final evaluation of this program) found that both of these designated poes were already highly consistent with the ihr requirements. during every assessment, it was ensured that the results were not compared between the poes because the tia is a site for human travelers, while the pok mainly handles cargo. the different situations cause different risks for human health, and need to be responded to differently. furthermore, competition among the poes may lead to the perusal of higher scores, rather than the core capacity itself. such competition should be avoided as far as possible. as the upcoming pok travel center, and a new tia terminal are expected to increase passenger numbers in the next few years, existing core capacities (such as the number of skilled personnel, facilities, or surge capacity) may not be enough to handle the magnitude of travelers. it is therefore necessary to be attentive to the needs of further improvement in the core capacities through an analysis of the potential impact of the rising numbers of passengers. enhancing emergency response capacity: a matter of concern the first two assessments found that capabilities to respond to radiological and chemical events effectively were underdeveloped or nonexistent in both, the tia and the pok; however, the response planning for a large-scale outbreak/pandemic had been established after the sars epidemic. these findings corroborated the evidence generated from the general review of global ihr implementation, specifically indicating that, 'the chemical, nuclear, and radiological threats encompassed in the the self-assessment (march ) develop an inspector training program to fulfill the knowledge/skill gaps. complete emergency response protocol, involving the decontamination planning. replenish equipment for detection and personal protection. the preliminary external assessment (august ) in addition to notifying upper-level authorities, it is necessary to make provisions for sharing information among competent authorities at other poes. all authorities shall be familiarized about the agreed response protocol to handle the information according to the level of confidentiality, reliability, and indicated action determined. as construction of a new travel center is currently being planned, it will be a good opportunity to consider inclusion of capacities that make it an ideal healthy and safe poe. ihr presents a unique challenge to the surveillance and response community in both developed and developing countries' ( ) . since the beginning of the implementation of the ihr poe program, there was a discussion on whether radiological and chemical capacities were needed to be involved in the assessments, as the who ambiguously described in one of the assessment indicators (part bi d. . ) that 'harmful contamination, other than microbial contamination, such as from radionuclear sources, could also be found on ships, but is outside the scope of this guidance'. further, due to the lack of international guidance, it seemed easier and less complicated to restrict the assessments to communicable diseases. however, it was subsequently determined that taiwan should not ignore radiological and chemical hazards because the type of accidents that may occur at the poes cannot be predicted or selected. sometimes, an accidental or deliberate release of chemical, biological, and radiological agents on arriving conveyances would have the potential to cause adverse health and financial consequences ( ) . in this case, imported risks cannot be identified, nor be properly dealt with, without the relevant surveillance and response capacities. the fukushima nuclear disaster in highlighted the need to involve diversified public health risks in taiwan. since then, more than containers imported from japan have been detected as being contaminated in the pok. in this case, once possible potential nuclear hazard was detected, the custom authority, authorized to undertake radiological inspections, will implement a series of sops including risk identification/evaluation, reporting, ppes for staff, etc. through understanding the risk profile of the tia and pok as well as in consultation with technical experts dispatched by the central governments and national disaster response authorities, it was determined that the emergency response at poes level should meet the following six basic criteria: ) poe response protocols are aligned with those at the national and local level to ensure the seamless flow of information from the various response systems; ) clear identification of duties and responsibilities of each stakeholder; ) knowledge and equipment for early detection and personal protection; ) communication mechanisms to disseminate information to relevant stakeholders at the poes; ) access to external assistance from the local or central disaster response system; and ) clear command and control system before the arrival of external assistance, and the process of command transfer. according to the criteria defined above, the tia and pok updated their emergency plans, and integrated them into protocols for various types of pheics ( , ) . the drafts were submitted to stakeholders at the poe and national disaster response authorities for peer-review before finalization. meanwhile, required equipment was provided for the initial detection and personal protection (amount and type of equipment were suggested by experts from central authorities). in addition, as the success of any response is highly linked to the people who perform their roles, the required competencies and skills needed for specific response personnel were identified, and relevant training programs were designed. regular drill exercises were conducted to verify the adequacy and interoperability of the plans, as well as to increase the stakeholders' familiarity with their responsibilities and operational procedures. through the abovementioned efforts, the reviewers of the follow-up assessment noted a significant progress in establishing emergency response sops, as well as ensuring that resources were available to ensure rapid responses. from these experiences, it was learned that despite a lack of international principles and guidance for establishing core capacities, countries should try to take its own decisions on what to do and how to do it, based on its current infrastructure, and resources and demands. in addition, where possible, countries should build on existing systems and infrastructure for strengthening their capacities, rather than immediately investing in large-scale systems or infrastructure changes. the advocacy of the ihr poe program was very challenging initially. due to a lack of understanding of the ihr , key stakeholders at central ministries and poes perceived that the regulations were only under the jurisdiction of the health ministries. therefore, the tcdc invested considerable effort in advocating the aim and concepts of the ihr . despite these efforts, the ihr poe program was not implemented very smoothly, due to the resistance and complaints from the field, until the japan fukushima nuclear disaster occurred in . fearing the impact of nuclear contaminations (as traffic and trade are very frequent between japan and taiwan), people working at the poes were keenly aware of the importance of protecting themselves by enhancing the surveillance and response system. they found a selfmotivated actor ( ) to participate in developing the poe's core capacities, and gradually realized that they were jointly contributing to something beneficial for their own workplace, safety, and health. this change of attitude was helpful for further activities. subsequently, to protect themselves, these stakeholders were willing to think about and invest more efforts in developing capacities to address the emergency response. for instance, people were very concerned if they were to be notified about anything unusual. therefore, they carefully reviewed and updated the contact details of every stakeholder to ensure that event information can be disseminated immediately. it was also observed that the process of preparing for each assessment brought the stakeholders closer. as they shared the same objective of obtaining better results for the next assessment, partners involved in the poe met frequently to discuss matters. this extensive participation of various professionals led to a robust unity and mutual understanding. the reviewers observed that all the relevant units at each poe were united with a well-organized structure, and the contribution of the staff toward the implementation of the ihr was a major strength in the implementation of core capacities at poes in taiwan. it is believed that this solidarity shaped through the ihr poe program will continue even after the core capacity requirements have been fulfilled. it shall be continuously beneficial, not only for the daily operation of the poes, but also in co-confronting future crises. strong national efforts throughout all the governmental agencies, to achieve the core capacity requirements at the poe, were noted by the reviewers of the preliminary and follow-up external assessments. sometimes the application of the program was affected by bureaucracy and sectionalism, especially with reference to jurisdiction and expenditure allocation. the solution was the continuous communication and strong commitment of the higherlevel authorities to carry through the program and to arbitrate contentions. thus, taiwan was inspired by the reviewers' conclusions that the progress achieved is testament to the strong commitment, professionalism, and enthusiasm demonstrated by the staff, in their respective roles. this article introduced a new, but applicable, model that taiwan developed for developing ihr core capacities at designated poes. the ihr poe program focused on ) designating two poes according to the pre-determined criteria, ) identifying the competent authority for each health measure, ) building a close collaborative relationship with stakeholders from the central and poe levels, ) designing and implementing three stages of systematic assessment, and ) undertaking action plans targeting the gaps identified by the assessments. with incessant efforts invested in the 'learning by doing' process, the designated poes of tia and pok were assessed as highly consistent with the capacity requirements of the ihr . as many countries had requested extensions to fulfill the ihr core capacity requirements ( ) , it is expected that experiences generated from taiwan can provide some clues on how to identify and strengthen core capacities at designated poes. nevertheless, the achievements of the ihr poe program do not imply an end, of a process, but are a starting point to address the increase in international traffic, and to respond to future challenges at airports and seaports effectively. as the reviewers suggested, it is necessary to continue to maintain core capacities in the designated poes and flexibly adjust the overall strategy in the face of new diseases (such as middle east respiratory syndrome coronavirus infection or new strains of avian flu), new terms of emergencies, new international guidance, as well as new transporting routes and destinations. for this purpose, the taiwanese government will remain committed toward implementing and reviewing the content of the ihr poe program. so far, the coordination and collaboration at poes functioned well in response to the h n outbreak that began in china at the end of march . the emergency of a new disease reminded taiwan that the collaborative mechanism and the partnership, which were already successfully triggered or shaped, should be continuously maintained to ensure the sustainability of the core capacities. currently, taiwanese government has launched the second stage of the ihr poe program. five more poes (three airports and two seaports) have been identified as designated poes to develop their core capacities. the new task will rely highly on the experiences from the development undertaken at the tia and pok. in addition, it will adapt to the characteristics of the specific poes and the ever-changing environment. these efforts are expected to extend the safety of the lives and property of taiwanese people extensively and to bolster the competitive advantages of poes in taiwan. global health improvement and who: shaping the future learning from sars in hong kong and toronto germs, governance, and global public health in the wake of sars geneva: world health organization ihr core capacity monitoring framework: checklist and indicators for monitoring progress in the development of ihr core capacities in states parties ihr brief no assessment tool for core capacity requirements at designated airports, ports and ground crossings. geneva: world health organization implementation of the international health regulations at points of entry from the german perspective guidance for public health units about the core capacities required at new zealand international airports under the international health regulations meeting on points of entry capacity and preparedness for public health emergency response under the international health regulations international health regulations ports, airports and ground crossings. international health regulations awareness workshop for btwc delegations the decision making process for public health measures related to passenger ships: the example of the influenza pandemic of targeting public health events on ships world health organization department of global capacities, alert and response. world health organization perspective on implementation of international health regulations disease surveillance, capacity building and implementation of the international health regulations (ihr audit report Á quarantine, migration and travel health and international health regulations port of rotterdam. establishment of 'virtual' port health authority rotterdam. press releases and news articles actions for prevention and control of health threats related to maritime transport in european union guide for public health emergency contingency planning at designated points of entry. geneva: world health organization building national public health capacity for managing chemical events: a case study of the development of health protection services in the united kingdom challenges to the implementation of international health regulations ( ) on preventing infectious diseases: experience from julius nyerere international airport report by the director-general in sixty sixth world health assembly a / building core capacities at the designated poes in taiwan citation: glob health action we wish to thank the numerous government agencies and individuals who jointly contributed to the success of fulfillment of ihr core capacities at the designated poes in taiwan through the years. we also thank our partner countries for generously sharing their experiences and providing technical advices. we especially gratefully acknowledge dr. kiyosu taniguchi from japan, ms. teresa morahan and ms. gigi o'sullivan from australia, whose expertise and efforts had been fervently devoted in assisting our works. the authors declare that they have no conflict of interests. key: cord- - muxz c authors: phillips, sally; lavin, roberta title: readiness and response to public health emergencies: help needed now from professional nursing associations date: - - journal: j prof nurs doi: . /j.profnurs. . . sha: doc_id: cord_uid: muxz c nan t he tragedy of september , anthrax attacks, and severe acute respiratory syndrome (sars) and other recent infectious disease outbreaks have heightened our awareness of the need for health care system readiness and response capabilities. at the same time, the economic realities of our modern health care system are reflected in cost-containment strategies toward low-volume inventories, reduced bed availability, downsizing of staff, and a shift to outpatient services (american hospital association, ) . decreased reimbursement structures and workforce shortages have diminished the health care system's ability to meet minimum patient demands, let alone the surge of patients that would be expected in a mass-casualty incident. furthermore, the infrastructure needed for detection and response from the public health sector has been seriously eroded by decades of insufficient funds. agencies within the department of health and human services (hhs) have been working to address readiness and response capabilities, but private organizations and professional associations also have a role to play. in keeping with the public health security and bioterrorism preparedness and response act of , hhs developed a department-wide strategic plan to delineate its priorities. within the plan, the centers for disease control (http://www.bt.cdc.gov) and health resources and services administration (hrsa; http://www.hrsa.gov/bioterrorism. htm) have strategic activities in education, training, licensure, and credentialing for the public health care workforce and for hospital readiness. the agency for healthcare research and quality also has strategic activities related to education and training, as well as uses of information technology and electronic communication networks (phillips, burstin, dillard, & clancy, ; . hhs's working definition of health surge capacity is the ability a health care system has to rapidly expand beyond normal services to meet the increased demand for medical care and public health services that would be required to care for patients in the event of a large-scale public health emergency or disaster. needed resources include beds, personnel to staff the beds, equipment, ability to transport victims and personnel, and the ability to provide ongoing care. all aspects of surge capacity present challenges, but the demand for qualified health care personnel is particularly complex. although nursing is not the only health profession experiencing a workforce shortage, nursing is vital to any largescale demand for care. nationally, there are , , licensed registered nurses, or registered nurses per , people (hrsa, ) . these numbers are insufficient to meet current capacity needs and would be woefully inadequate in the event of a mass-casualty incident. a masscasualty event would require mobilization of additional nurses from outside the affected jurisdiction. such a mobilization, however, would have to overcome issues of credentialing and licensing. when licensed health care clinicians arrived as good samaritans and volunteered after / , hospital administrators turned them away because they did not have the proper credentials. nurses must collaborate and coordinate and train for future crises. issues of competency, standards, and mechanisms for education and training must be approved to certify qualified nurses for mass-casualty events. a major step was taken in march , when the international nursing coalition for mass casualty education (incmce) was founded to ensure a competent nurse workforce in response to mass-casualty incidents. the incmce consists of organizational representatives from schools of nursing, nursing accrediting bodies, nursing specialty organizations, and governmental agencies. in july , incmce developed a set of national, consensus-based, validated competencies for all entry-level nurses (incmce, ) . nurses must also initiate systems that promote their ability to respond in the next crisis. in , president clinton signed presidential decision directive/nsc- (white house, ) , which established a national strategy for ensuring critical infrastructure protection, primarily cybersecurity. in , president bush replaced pdd- with homeland security presidential directive (white house, ) , which identified the roles of the health care and public health sectors. specifically, it charged the sector-specific agencies to "collaborate with appropriate private sector entities and continue to encourage the development of infor- mation sharing and analysis mechanisms" (pdd- ). under the directive, hhs established the healthcare sector coordinating council, which has responsibility for activities such as communicating potential risks, threats, and vulnerabilities to private organizations. nurses make up the largest health profession, yet they lack a mechanism that enables them to gather and disseminate nursing-specific information and communicate potential risks, threats, and vulnerabilities. a coordinating group comprising nurses from university, public health, and response settings, with a secure system that would allow collaboration on issues like identifying and providing a roster of volunteers, would be a good national, consistent approach to identifying and addressing vulnerabilities. this group would provide valuable insight to and receive vital information from the healthcare sector coordinating council and would disseminate that information to nurses throughout the country. nurses would be better prepared and the country would be safer. it is time for nursing to endorse such an entity and become engaged at this level of strategic initiative. by the american hospital association with the support of the office of emergency preparedness, us department of health and human services ahrq's bioterrorism research portfolio: real linkages in real time the agency for healthcare research and quality responds to emerging threats of bioterrorism homeland security presidential directive key: cord- -venpta authors: filgueiras, a.; stults-kolehmainen, m. title: factors linked to changes in mental health outcomes among brazilians in quarantine due to covid- date: - - journal: nan doi: . / . . . sha: doc_id: cord_uid: venpta the covid- pandemic is a crisis of global proportions with a significant impact on the country of brazil. the aims of this investigation were to track changes and risk factors for mental health outcomes during state-mandated quarantine. adults residing in brazil (n = , . years of age, . % female) were surveyed at the start of quarantine and month later. outcomes assessed included perceived stress, state anxiety and depression. aside from demographics, behaviors and attitudes assessed included exercise, diet, use of tele-psychotherapy and number of covid- related risk factors, such as perceived risk of covid- , information overload, and feeling imprisoned. overall, all mental health outcomes worsened from time to time , although there was a significant gender x time interaction for stress. . % of the sample reported stress above the clinical cut-off ( sd above mean), while . % and . % were above this cutoff for depression and anxiety, respectively. in repeated measures analysis, female gender, worsening diet and excess of covid- information was related to all mental health outcomes. changes in diet for the worse were associated with increases in anxiety. exercise frequency was clearly related to state anxiety ( days/week > days/week). those who did aerobic exercise did not have any increase in depression. use of tele-psychotherapy predicted lower levels of depression and anxiety. in multiple regression, anxiety was predicted by the greatest number of covid- specific factors. in conclusion, mental health outcomes worsened for brazilians during the first month of quarantine and these changes are associated with a variety of risk factors. the covid- pandemic is a crisis of global proportions with a significant impact on the country of brazil. the aims of this investigation were to track changes and risk factors for mental health outcomes during state-mandated quarantine. adults residing in brazil (n = , . years of age, . % female) were surveyed at the start of quarantine and month later. outcomes assessed included perceived stress, state anxiety and depression. aside from demographics, behaviors and attitudes assessed included exercise, diet, use of tele-psychotherapy and number of covid- related risk factors, such as perceived risk of covid- , information overload, and feeling imprisoned. overall, all mental health outcomes worsened from time to time , although there was a significant gender x time interaction for stress. . % of the sample reported stress above the clinical cut-off ( sd above mean), while . % and . % were above this cutoff for depression and anxiety, respectively. in repeated measures analysis, female gender, worsening diet and excess of covid- information was related to all mental health outcomes. changes in diet for the worse were associated with increases in anxiety. exercise frequency was clearly related to state anxiety ( days/week > days/week). those who did aerobic exercise did not have any increase in depression. use of tele-psychotherapy predicted lower levels of depression and anxiety. in multiple regression, anxiety was predicted by the greatest number of introduction mental health comprises the set of emotions, thoughts and behaviours that enable individuals to work, cope and deal with problems in everyday tasks (who, ) . historically, although researchers from the biomedical sciences dedicated more time and resources in the study of physical health, findings from the last years have slowly captured the interest of scientists from diverse fields to look upon mental health to explain somatic diseases, physical functioning, quality-of-life, well-being and work productivity, (christensen et al., ; prince et al., ; stults-kolehmainen, tuit & sinha, ) . for instance, mental health is associated with disability-adjusted life years (dalys) and premature mortality (vigo, kestel, pendakur et al., ) with % of dalys attributable to mental health in brazil and % in the united states. those with worse mental health, such as higher levels of chronic stress, have a greater risk for physical health problems, such as cardiovascular disease (stults-kolehmainen, ). poor mental health costs society a great deal of money, in terms of lost productivity, strain on healthcare systems, loss of income and other consequences (trautman, rehm, wittchen, ). on the other hand, recent research from the world health organization suggests that every one american-dollar spent in mental health care is equivalent to a return of four american-dollars in better well-being and ability to work (who, ).thus, a person who has good mental health entails someone who is physically healthy, happy and productive for themselves and the greater functioning of society (prince et al., ; who, ) . the recent outbreak of the corona virus disease (covid- or sars-cov- ) around the world at the end of and the beginning of led to a series of guidelines to avoid mass contamination and limit its lethality (who, ). among these recommendations are quarantine, confinement and social distancing (wilder-smith & freeman, ). these impositions mean that people cannot walk freely from their homes; they need to keep a -meter physical distance from one another on the streets and sick people are obliged to be confined in hospitals or their own homes without any kind of physical proximity to others. these restrictions are intended to benefit the physical health and safety of all people and must be adopted to save lives. unfortunately, such directives come at a cost to the mental health and well-being a substantial proportion of the population (rubin & wessely, is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . an updated systematic review on the effects of social distancing and quarantine on mental health revealed that anxiety, depression, stress, anger, insomnia, hopelessness, and sadness were all increased during those conditions (brooks et al., ) . a recent study (hu, su et al., ) from a cross-national sample (n = ) in china found that levels of anxiety increased, and . % of the population was anxious at clinically relevant levels. other behavioural problems also appear during this period; participants in a nationwide survey recently published in china reported nutritional issues, lack of ability to exercise and numerous changes in daily routines and habits (qiu et al., ) . accordingly, psychosocial and behavioural dimensions seem associated under quarantine conditions (filgueiras & stults-kolehmainen, unfortunately, resources are scarce in every field of the health system, including those for mental health (qiu et al., ) . therefore, it is pivotal to establish a priori where and how to invest those scarce resources. this is a difficult task because the current stressor is highly unique. quarantine is due to a pandemic of truly global proportions that has reached every level of society, with a long duration and remarkable social upheaval (who, ). there is no research on the association between psychological, demographic and behaviour variables in the general population during society-wide social isolation. furthermore, it is a consensus that psychological phenomena, such as stress and depression, are multifactorial with a large amount of variables to consider (who, ; ) . in order to help governments, service providers and scientists to . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) comparing before and during quarantine (options were "no changes"; "increased exercise frequency" and "decreased exercise frequency") and (xiii) types of exercise (aerobic, anaerobic, both, no exercise). it also collected data regarding diet and nutritional habits: (xiv) possible changes on diet by comparing before and during quarantine; whether the person (xv) gained or (xvi) lost more than kilograms since the beginning of the quarantine. finally, attitudinal questions were also computed. one question (xvii) asked about the amount of information the participant felt he/she was receiving and the answers were provided in three possible categories to choose from: "too much information", "enough information" and "little information". . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . another three items were informed in a five-point likert-type scale ranging from "totally agree" to "totally disagree"; the items were: (xviii) "do you feel imprisoned due to this quarantine?", (xix) "do you feel you are able to understand what is happening?", (xx) "do you trust your own ability to differentiate good from bad sources of information?". the pss- (cohen & williamson, ) is a -item questionnaire that asks individuals about their perception regarding stress-like symptoms. it is answered in a five-point likert-type scale ranging from "never" to "very often" (scores range from - ). the population mean is . (sd = . ) with a score over indicating excessive stress (cacciari, haddad, dalmas, ) . the fdi (filgueiras et al., ) is a -item scale that asks individuals to grade the level of association between the respondent's own self-perception and one-word items extracted from depression symptoms listed in the dsm-v in the last fortnight. it is rated in a six-point likert- type scale ranging from "not related to me at all" to "totally related to me" (scores range from - of the respondent who answers questions about own feelings in a four-point likert-type scale ranging from "not at all" to "very much so" (scores range from - ). gender-specific reference means are . (sd = . ) for men and . ( . ) for women, with cut-offs being for men and for women (pasquali, pinelli jr, soha, ) . volunteers of the present research answered the questionnaires in the google forms online platform that was configured in the same order of presentation: ) term of consent, ) demographic and attitudinal questionnaire, ) pss- , ) fdi, ) s-stai, ) thank you page. those participants who answered "no" to the term of consent were addressed to the thank you page without having any contact with the other questionnaires. first round of data collection (time ) took place between march th and march th , , whereas the second round (time ) happened between april th and april th , . after data collection, google spreadsheets were utilized to consolidate the database and to export it in the format .csv. then, researchers used spss (ibm, version . ) to run the analyses. descriptive statistics of pss- , fdi and s-stai were calculated for each categorical (demographic) variable with exception of those that were answered in likert-type scales. due to the large amount of variables collected in an online platform, cronbach's alpha (α) was calculated for the three scales in time and time ; results were expected to show α > . . pairwise t-test comparisons between groups were computed to identify significant differences between the first round (time ) and second round (time ) of data collection for the whole sample. a repeated-measures anova was performed to compare within and between groups for each demographic independent variable. furthermore, prevalence of stress, depression and anxiety-like symptoms were calculated in percentage of participants above the means and cut-off . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . for perceived stress, ( . %) and ( . %) of participants scored above the population mean at time and , respectively. prevalence of excessive stress (> sd above reference mean) was . % (ic . %- . %) in the first round and . % (ic . %- . %) in the second round. of the individuals in this category, % of these individuals were women. % did no exercise at all, but the remaining % complete days a week of exercise. also, % utilized tele-psychotherapy. regarding depression, ( . %) and ( . %) of participants were above the reference mean at time and , respectively. high depression (> sd above reference mean) had a prevalence of . % (ic . %- . %) at time and . % (ic . %- . %) at . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . time . participants > sd (n = ) were mostly women ( %) and did not utilized tele psychotherapy ( % as exercise frequency and perceived stress (r = -. ); whereas, moderate correlations were found between the same variable between time and time (intertemporal correlations). tables and supplemental provide the correlation matrix of the psychological variables. to understand what is happening, level of education and gender respectively. independent variables explained % of the variance of depression in the second round of data collection. finally, the state anxiety lmr depicted that the dependent variable (s-stai time ) was predicted, in order of association, risk for covid- , feeling safe, the score of s-stai time , weight loss, changes on diet, amount of information, feeling imprisoned and age. independent variables of this lmr explained cumulatively % of the variance. table presents the coefficient β , the t-test statistics, effect-size and coefficient of determination for the three lmr. the current investigation provides a unique glimpse into the mental health of brazilians in the midst of quarantine from the covid- pandemic, a novel, disruptive and society-wide stressor. findings indicate that a substantial portion of respondents were distressed at both time points, . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . https://doi.org/ . / . . . doi: medrxiv preprint with worsening mental health from the initiation of quarantine to a point one month later. more specifically, increases in perceived stress, depression and state anxiety were observed, with a gender x time interaction recorded for stress. men experienced increases in depression and anxiety over time, but not for perceived stress. across genders, the number of days in quarantine was linearly related to worse perceptions of perceived stress. repeated measures anova revealed that factors were all related to worse levels of stress, depression and anxiety: female gender, worsening diet and excess of covid- information. in regression analyses, however, mental health outcomes were influenced by a variety of other demographic, covid- specific, and behavioural factors, such as use of tele-psychotherapy. exercise-related factors, such as exercise frequency, were the predominate predictors of perceived stress. a substantial portion of the participants reported levels of stress, depression and anxiety above established means for the population. at time , greater than % of the sample was above the normative mean for both stress and depression. for anxiety, > % of both men and women were above the normative mean. more importantly, some participants scored very high for mental health disturbances, especially at time . for stress, . % of the sample was above sd at time , whereas the prevalence according to the brazilian norms is . % (cacciari, haddad & dalmas, ) . this was an increase from . % at time . similar trends were seen for depression ( . % at time , . % at time ; versus a norm of . %) (filgueiras et al., ) and state anxiety ( . % increasing to . %; versus a norm of . %) (pasquali, pinelli jr & solha, ) . this is similar to anxiety levels observed in a large sample during quarantine in china (hu, su et al., ) . while the percentage of individuals scoring at these extremes is still relatively low, it potentially represents a huge increase in burden to society when multiplied across the entire population. mental health initiatives on the national level would have to be scaled up to meet new demand (who, ) . key to this endeavour would be a) identifying those most at risk and b) properly assessing their condition. in the effort to identify those most at risk, pertinent predictors of mental health outcomes were analysed. interestingly, each mental health indicator was predicted by a varying set of factors. condition of regrets about the past (buechler, ) , was understandably not predicted by covid- related factors. only "understanding what is happening" was a significant inverse predictor. stress was predicted by feelings of being imprisoned, days in quarantine and risk for covid- and also by a number of exercise factors. in general, exercise was associated with mental health outcomes in the expected manner -more frequent exercise and aerobic exercise being related to the lowest levels of distress. for all . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. the copyright holder for this preprint this version posted may , . . mental health outcomes, those with no exercise ( days per week) had the highest average levels of stress ( . at time to . at time ), depression ( . to . ) and anxiety ( . to . ). these seems to support the previous findings that "something is better than nothing" ( slightly different, with changes in exercise not being significant, but use of online fitness coaching reaching significance. an interaction was observed in that those who performed aerobic exercise had the lowest levels of depression at both time points. in fact, those who did aerobic exercise did not have any increase in depression. however, the clearest association of exercise frequency and mental health was for anxiety. those at the highest levels of exercise had the lowest anxiety and each day less was associated with more anxiety. aside from exercise, there were notable findings for dietary habits and use of tele- psychotherapy. those who rated their dietary habits as becoming worse also had the highest levels of stress, depression and anxiety. those with the highest levels of anxiety were those with worsening diet at the second time point (effect size for interaction was . ). those who used online nutrition services had lower levels of depression, but there was no difference for stress or anxiety. those who utilized online psychotherapy reported lower levels of depression and anxiety. while there is no income data to explain use of online resources, those using online resources were more educated. thus one might surmise that those from better off demographic groups are less affected partly because of greater access to resources. given the limited quantity of resources to mitigate mental health impairments during crises, such as pandemic and quarantine, it is crucial to identify the risk factors that may predispose individuals for worsening outcomes. despite the progress this study makes in tracking changes in mental health and identifying risk factors, the current research does demonstrate some limitations. first of all, there was no pre- quarantine baseline and assessments spanned just a single month. furthermore, this was a relatively well-off population with higher-educated individuals being over-represented in the sample. there was no measure of adherence to quarantine guidelines. it is possible that those with higher compliance to regulations could be of either higher or lower distress. to lessen . cc-by . international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) the copyright holder for this preprint this version posted may , . . survey fatigue for participants, validated measures of exercise and dietary habits, which can be very lengthy, were not utilized. more importantly, the current data needs interpreted with some caution because factors other than quarantine could contribute to changes in the mental health outcomes observed, such as growing political and economic unrest in brazil (the lancet, ). also, it should be noted that effect sizes for changes over month were small (cohen's d were . -stress, . -depression, and . -anxiety), possibly because in some cases individuals had improved mental health (n = ; . %) due to quarantine conditions, such as being closer to loved ones throughout the day or being removed from dangerous work environments. lastly, correlations between instruments at time or time were small -possibly indicating the uniqueness of the quarantine as a stressor, particularly given the rapidly changing circumstances during this time period (main, zhou et al., ) . this study provides crucial data needed to understand how pandemic, state-mandated quarantine is related to changes in mental health outcomes. from the time point when quarantine was decreed until month later, worsening perceived stress, depression and anxiety was observed in this sample of the brazilian population. moreover, many individuals in the sample reported very high levels of distress (> sd). at the time of writing of this study, the quarantine is still being enforced and cases of covid- and associated deaths on rising rapidly (the lancet, ; imperial college covid- response team, ). future research should continue to track these trends as the crisis unfolds. analyses from this study identified several risk factors for mental health, including gender (being female), lower education, less exercise, worsening diet and a lack of resources, such as access to tele-psychotherapy. covid- related factors predicted anxiety and stress more so than depression. the implications of these data is clear; mental health worsens with great change, requiring more resources to improve the experience of life in quarantine. the extent to which these can be diligently developed and allocated will depend on a data-driven process such as described here. everyday stressors and gender differences in daily distress survey of stress reactions among health care workers involved with the sars outbreak the psychological impact of quarantine and how to reduce it: rapid review of the evidence la alegría, la vergüenza, el arrepentimiento y la tristeza en la terapia nível de estresse em trabalhadores readequados e readaptados em universidade estadual pública. texto & contexto-enfermagem hope, hopelessness, and anxiety: a pilot instrument comparison study perceived stress in a probability sample of the united states age differences in depression and anxiety symptoms: a structural equation modelling analysis of data from a general population sample. psychological medicine the effect of exercise on clinical depression and depression resulting from mental illness: a meta-analysis walking in (affective) circles: can short walks enhance affect? development and psychometric properties of a novel depression measure the relationship between behavioural and psychosocial factors among brazilians in quarantine due to covid- . ssrn, e feeling safe and content: a specific affect regulation system? relationship to depression, anxiety, stress, and self- criticism sars control and psychological effects of quarantine countrywide quarantine only mildly increased anxiety level during covid- outbreak in china. medrxiv short-term forecasts of covid- deaths in multiple countries mapa brasileiro da covid- [brazilian map for covid- mental health status of people isolated due to middle east respiratory syndrome physical activity and mental health relations of sars-related stressors and coping to chinese college students' psychological adjustment during the beijing sars epidemic diet quality and depression risk: a systematic review and dose-response meta-analysis of prospective studies gender differences in depression. current directions in psychological science the association between physical activity and depression among individuals residing in brazil. social psychiatry and psychiatric epidemiology relationship between diet and mental health in children and adolescents: a systematic review contribuiçäo à validaçäo e normalizaçäo da escala de ansiedade-traço do idate no health without mental health a nationwide survey of psychological distress among chinese people in the covid- epidemic: implications and policy recommendations the psychological effects of quarantining a city decreto . : decreta quarentena no estado de são paulo, no contexto da pandemia do covid- (novo coronavírus), e dá providências complementares stai: manual for the state-trait anxiety inventory education level, income level and mental health services use in canada: associations and policy implications the interplay between stress and physical activity in the prevention and treatment of cardiovascular disease the effects of stress on physical activity and exercise. sports medicine lower cumulative stress is associated with better health for physically active adults in the community factors influencing psychological distress during a disease epidemic: data from australia's first outbreak of equine influenza covid- in brazil the economic costs of mental disorders disease burden and government spending on mental, neurological, and substance use disorders, and self-harm: cross-sectional, ecological study of health system response in the americas physical activity and depression: is min/week of moderate to vigorous physical activity a necessary threshold for decreasing risk of depression in adults? different views from the same data. social psychiatry and psychiatric epidemiology isolation, quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus ( - ncov) outbreak out of the shadows: making mental health a global development priority world bank group and world health organization promoting mental health: concepts, emerging evidence, practice (summary report). geneva: world health organization considerations for quarantine of individuals in the context of containment for coronavirus disease (covid- ): interim guidance the anxiolytic effects of exercise: a meta-analysis of randomized trials and dose-response analysis the present research is funded by the coordenacao de aperfeicoamento de pessoal de nivel superior (capes) of the ministry of education of brazil under the proap program. key: cord- -yz buegp authors: gushulak, bd; weekers, j; macpherson, dw title: migrants and emerging public health issues in a globalized world: threats, risks and challenges, an evidence-based framework date: - - journal: emerg health threats j doi: . /ehtj. . sha: doc_id: cord_uid: yz buegp international population mobility is an underlying factor in the emergence of public health threats and risks that must be managed globally. these risks are often related, but not limited, to transmissible pathogens. mobile populations can link zones of disease emergence to lowprevalence or nonendemic areas through rapid or high-volume international movements, or both. against this background of human movement, other global processes such as economics, trade, transportation, environment and climate change, as well as civil security influence the health impacts of disease emergence. concurrently, global information systems, together with regulatory frameworks for disease surveillance and reporting, affect organizational and public awareness of events of potential public health significance. international regulations directed at disease mitigation and control have not kept pace with the growing challenges associated with the volume, speed, diversity, and disparity of modern patterns of human movement. the thesis that human population mobility is itself a major determinant of global public health is supported in this article by review of the published literature from the perspective of determinants of health (such as genetics/biology, behavior, environment, and socioeconomics), population-based disease prevalence differences, existing national and international health policies and regulations, as well as inter-regional shifts in population demographics and health outcomes. this paper highlights some of the emerging threats and risks to public health, identifies gaps in existing frameworks to manage health issues associated with migration, and suggests changes in approach to population mobility, globalization, and public health. the proposed integrated approach includes a broad spectrum of stakeholders ranging from individual health-care providers to policy makers and international organizations that are primarily involved in global health management, or are influenced by global health events. several current emerging threats and risks exposing public health vulnerabilities are linked to global processes, such as economics, trade, transportation, environment and climate change, and civil security. many of these processes are influenced or affected by the migration and mobility of human populations. , international migration, which is a supporting component and a consequence of globalization, increasingly affects health in migrant source, transit, and recipient nations. the flow of populations between locations with widely different health determinants and outcomes creates situations in which locally defined public health threats and risks assume international or global relevance. this fact is illustrated by the rapid awareness, detection, and response to the emergence of a novel influenza a/h n virus in the spring of . , global demographic predictions indicate that the forces promoting and supporting international migration will continue to do so, and may become stronger in all regions of the world as populations attempt to move up gradients of opportunity (such as economic, educational, security, health). both the diversity (the term 'diversity' describes the dissimilarities between host and migrant populations relevant to the determinants of health (such as genetics and biology, environment, behavior, and socioeconomics); 'disparity' reflects the burden of inequalities present at both individual and societal levels, which affects the determinants of health.) and the nature of modern mobility and migration frequently exceed the capacities of and thereby challenge existing policies and programs designed to address migration and health. the goals of this paper are to promote a change in thinking and approach to global health issues that reflects emerging evidence and importance of population-based factors, as opposed to disease or pathogen-based regulatory frameworks that have been traditionally used. this approach focuses on factors of human population mobility and shifting demographics that affect both health determinants and disease outcomes. attention in the public health community is traditionally drawn toward the potential and real effects of infectious diseases associated with migration. common examples observed in nations that receive migrant populations include tuberculosis [ ] [ ] [ ] [ ] and hepatitis b. [ ] [ ] [ ] however, sustained migration between disparate health environments also affects the longer-term epidemiology of chronic noninfectious diseases; this has a downstream impact on health promotion, health services for disease prevention and management, and occupational health outcomes at migrant destinations. as a result of these impacts, migration exerts increasing influence on public health policy, education of health-service providers, health system design, and service delivery. examples of these influences include the need to regulate or manage the use of alternative medicines and pharmaceuticals imported by migrants, or the introduction of alternative medical procedures. [ ] [ ] [ ] in terms of public health, migration has implications for recognition of threats, as well as for surveillance and response capacity. migration also influences broader aspects of the 'health of the public,' including the background burden of chronic or latent diseases (both infectious and noninfectious) and patterns of preexisting immunity; it also influences the use and uptake of disease prevention and health promotion interventions, and health-care service utilization in general. , ensuring that necessary information is both available and understood by diverse communities is an increasingly important aspect of public health planning and preparedness [ ] [ ] [ ] in nations with large mobile populations. this was recently shown by responses to the threat of influenza a/h n importation, which included quarantine, isolation, or preventive interventions. [ ] [ ] [ ] traditional regulatory approaches to public health risks in the context of migration are commonly disease oriented or event based. frequently, these concepts assume or are based on the view that a degree of homogeneity or similarity characterizes migrant populations; they also relate to the administrative or legal status of the population. this article puts forth the observation that many of the important public health aspects of migration originate from or are based on the diversity and disparity of the populations themselves and extend beyond the legal and temporal processes involved in changing one's residence. addressing migration-associated health threats and risks will be more effectively accomplished if approached from this population-based framework, rather than from traditional disease-or immigration status-based views. it is proposed that the development of standardized, programmatic approaches to health and migration that are based on collective international evidence would be an effective strategic and operational approach to global health. failure or further delays in addressing emerging health issues associated with migration and population mobility will continue to impair the effectiveness of policies and programs designed to tackle modern global health challenges. , methods the peer-reviewed literature was accessed through electronic searchable sites (pubmed, promed, and others) using standard search strategies for literature related to migrants, mobile populations, and specific disease outcomes. in addition, publicly available reports from international and national organizations and agencies were accessed for information on migrants, mobile populations, and health. organizations and agencies included the world health organization, international organization for migration, international labour organization, other united nations (un) agencies, world bank, centers for disease control and prevention (atlanta, usa), european centres for disease prevention and control, the health protection agency (uk), and others. in all the literature or reports, population demographics, source country, reporting region, and health outcome measurements were sought. as the study involved no contact with patients or individuals or personal medical information, research ethics approval was not sought. several factors associated with human population mobility make it a significant determinant of future health threats and risks for all regions of the world. these include the number of people on the move, as well as the diversity and disparity of population characteristics between source, transit, and recipient destinations. taken together, these factors exert a significant influence on the globalization of disease threats and risks. a third factor that continues to challenge objective measurement of health outcomes in migrants is the lack of standardization in terminology that applies to mobile populations. doing so would allow correlation and differentiation of populations on the basis of health-risk characteristics rather than administrative categories. part of the growth in migration is simply due to the increase in human population (the rate of growth is no longer increasing). the global population in was estimated at b . billion people. the global population estimate in was . billion. in , it was estimated that there were million international migrants. current estimates of international migrants place their numbers at b million. if this population were considered a national population, international migrants would be the world's fifth largest nation. a report from the un showed that % of all migrants resided in nations; migrants constitute at least % of the total population of nations; % of international migrants live in high-income economies; % of migrants have moved from a low-to-middle income country to a similar economically designated nation; and % of migrants have moved from a low-to-middle income nation to a high-income nation. ('south-to-south' migrants are about as numerous as 'south-to-north' migrants.) of the b million international migrants reported by the un in , b % arrived in the united states alone. these trends can be associated with profound demographic impacts on migrant source and destination countries. these global population figures, although important in their magnitude, also reflect significant differences in the demographic and health determinants of the migrants themselves. there are millions of migrant workers who leave their families behind to be supported by their financial remittances. the migrant worker population is increasingly composed of women, particularly within asia. these population figures also comprise refugees and internally displaced individuals who seek a safe haven and security after fleeing conflict and disaster (see table ). in addition, there are those populations for whom the numbers and statistics are less definitive. this refers to population movements of migrants without legal permission or authority to migrate, who enter and reside unofficially in a host country. the clandestine nature of these unauthorized migrant ('unauthorized migrants' is emerging as the preferred terminology for international migrants who arrive without the necessary approvals, permissions, or documents (such as identification, citizenship cards, visas, passports, and other travel documents). irregular migrants, undocumented migrants, and those who are smuggled or trafficked outside their own country are included in this terminology.) flows, including smuggling and trafficking, makes the determination of their numbers difficult and estimates inexact. the quality of data for unauthorized migrants decreases as the migration process becomes less formally organized. nonstandardized use of terminology describing migrants a major challenge in assessing health impacts of migration is the lack of agreed definitions and consistency in the use of terminology to describe migrant populations over time. some migratory movements may involve international travel across formal boundaries, whereas others, such as rural-urban migration and the internal displacement of populations through conflict or disaster may remain internal national processes. each of the processes and movements can be associated with several descriptive or definitive terms that can vary over time, use, location, and legal or administrative standards. the terminology used to describe a group of migrants in one location, for example, immigrants, may refer to a different migrant group in another setting. in some settings, the term 'immigrant' refers only to those accepted as residents in the destination country and granted legal status to remain there. in other jurisdictions, the term 'immigrant' may be used to refer to any foreign national including those without a formal legal status. although many health risks are associated with movement between locations with different health determinants and outcomes, many definitions of migrant populations currently are based on administrative measures, such as the duration of stay. the un distinguishes migrants according to the duration of stay, classifying them into long-term migrants (residence in a country other than the usual place of residence for months) and short-term migrants (a period of residence of months but o year). this definition does not apply to those individuals traveling for business, to visit friends or relatives, to seek medical treatment, or to undertake pilgrimage. this variability in the use of terminology and lack of direct descriptions related to health creates challenges in the analysis and interpretation of health outcomes associated with migration. international organizations and agencies are attempting to standardize the terminology of migration, but these activities are largely based on administrative and residency principles and may not adequately reflect the health characteristics and determinants of the person or population. furthermore, many modern migration flows are temporary or reciprocal, reflecting the global integration of economic, educational, and labor markets. such movements include populations composed of temporary and seasonal workers, international students, or medical tourists, as well as the growing numbers of those with dual or multiple citizenship and right of residence. these populations, although experiencing and reflecting the health and public health influences of migration, are not systematically captured in traditional national or international immigration statistics. it has been proposed that the health aspects of migration can be better addressed through a standardized, population health-based functional approach rather than by the administrative consideration of processes of modern migration (see table ; modified from gushulak and macpherson ). emerging health threats, risks, and challenges resulting from migration identifying threats related to migrant populations has been driven by historical outbreaks of transmissible infectious diseases of public health significance, such as plague and cholera. as seen in recent years with the severe acute respiratory syndrome (sars, ) and influenza a/h n ( pandemic), many national responses with regard to migrant populations tend to be traditional, on the basis of the principles of border inspection, isolation or quarantine, and exclusion. in migration health, threat and risk identification, assessment and management rarely occur 'pre-event.' examples of poorly studied health threats of potential societal and public health importance include domestic violence against migrant women in destination locations, , long-term impact of dietary changes , on the incidence of cardiovascular disease, diabetes, and certain forms of cancer in foreignborn migrants and their locally born offspring, or the importation of health services or pharmaceutical products from less-regulated environments, representing traditional but often unregulated or unmonitored patterns of self-care. efforts aimed at addressing these challenges can begin through the identification of vulnerabilities within different migrant populations. once identified, demographic and population-based risk analysis can reveal the extent to which mobility globalizes risks for national health systems. some health factors associated with migration are simply a function of the size of the populations on the move, and can be considered as affecting all migrants. there are specific factors associated with vulnerability, risk of illness, and adverse health outcomes that are not equally distributed across migrant groups. they may be relatively more prevalent in some migrant cohorts reflecting uneven influences of behavioral, environmental, genetic, biological, and socioeconomic determinants of health. migrants originating from areas of poverty, those who are forcibly displaced by conflict or environmental calamity, those with limited educational and linguistic skills, and those who are dependent on their communities for protection (such as people with preexisting health conditions, unaccompanied minors, the elderly, the young ,and single-parent families) are at greater risk of adverse health outcomes. at the same time, new arrivals who are subjected to legal, economic, and/or social exclusion can be very vulnerable to contracting disease resulting from poor living environments and exploitative working conditions, including lack of access to health care and preventive services. through a combination of genetic or biological, behavioral, environmental, and socioeconomic determinants of health, many global populations display major differences in the frequency and expression of poor health. the introduction of population movement into an area characterized by sustained differences in measures of population health allows for the transfer or elaboration of these characteristics between locations. this is a concept with far-reaching implications for health maintenance and promotion, disease prevention, intervention and health-services management, and education and training programs. in the sphere of infectious diseases, population mobility is one of the underlying factors in the emergence and reemergence of diseases of international public health importance as shown by communicable disease outbreaks. prevalence disparities between migrant source and destination countries can also exist for noninfectious diseases and conditions, although the direction of disparity from high to low prevalence and vice versa may vary depending on the condition being studied. as a consequence, migrant-receiving nations are sometimes required to respond to adverse health outcomes that originate beyond their jurisdiction and normal planning considerations. in addition, migrants who are subjected to legal, social, or economic isolation and deprivation may develop levels of ill health much different from those seen in the local or host population. taken together, evidence clearly suggests that health interventions and attempts to mitigate adverse health outcomes in migrant communities may require approaches that differ from those required by the locally born community. , the impact of migration on national health and disease epidemiology many economically advantaged nations have gained the benefits of long-standing and effective public health and disease-control programs. the effective control of tuberculosis in much of the high-income world means that the major remaining public health challenges presented by the disease in developed countries are related to migration. in terms of noninfectious conditions and chronic diseases, programs directed at detection and treatment for malignancies (cervical, breast, and colon), interventions to manage anemia and some endocrine disorders, and the significance of maternal-child health issues have resulted in the moderation of the impact of these illnesses locally. migration from less economically advantaged areas will affect the epidemiology of diseases in 'low-incidence' host environments. this is particularly true for diseases that occur at very low incidence levels, or which have been virtually eliminated locally. the relationship between migration and disease epidemiology at the destination of the migrant is not always negative. differential risk and variability in adverse health outcomes may exist between migrant and host populations for a number of diseases. variations in prevalence may go in several directions or vary over time and across generations. health impacts of population mobility may occur in an epidemiologically neutral context. large populations of labor migrants moving within asia or western europe represent situations in which there may be no significant health disparities between mobile and host populations, and any significant migrant effects on health instead are related to the scale of demand for services. finally, population mobility may result in situations in which new arrivals exhibit more positive health characteristics than those observed in the host population. examples of the latter type are observed in the context of some noninfectious or chronic diseases, such as cardiovascular diseases and eating disorders, and are described as representing the 'healthy immigrant effect.' , even this 'healthy immigrant effect' concept varies depending on time, social situation, and clinical condition. although preexisting health conditions and illnesses can be associated with changes in disease patterns, the act of migration can also pose new threats and health risks. postmigration public health impacts include the consequences of ill health when newly arriving migrants experience isolation, social exclusion, and/or poverty. in situations in which migrant communities' access to health or social services is limited, post-arrival susceptibilities may increase, manifested by the expression of a more severe or advanced disease. programs and strategies designed to promote and improve the health of migrants and mobile populations vary between nations. they often reflect national health priorities and local migration dynamics. examples include developing migrant-friendly clinics and hospitals, ensuring that some categories of unauthorized migrants, such as those without documents, can receive care without being reported to immigration authorities, providing medical care or screening guidelines indicating the role had by mobile populations in the epidemiology of a given disease or illness, and in terms of public health risk, considering migrant and mobile populations in emergency and contingency plans for disease risk mitigation. health system challenges migration-associated adverse health outcomes present two sets of challenges to health systems in migrant-receiving nations. the first challenge is the early appreciation and recognition of the diversity and disparity components of the population, which could result in significant migrant health issues. early recognition can be achieved through effective engagement of the health-services system by a health professional or the migrant. the size of the migrant population and the diversity within migrant communities and populations can mask significantly different groups with disease vulnerabilities. health practices may differ significantly by group, particularly in health-promotion strategies and approaches to disease screening between source and host nations (for example, hypertension, diabetes in pregnancy, colon, uterine or breast cancer). these differences may also extend to infectious disease prevention and control measures, such as vaccination or outbreak response. if health indicators are collected or recorded in terms of broad administrative classifications, such as 'migrant' or 'place of birth,' health risks in populations composed of internally displaced, refugees, or trafficked individuals may be obscured. the second set of challenges is related to access to care for migrant populations. even with the recognition of adverse health outcomes in migrant populations, providing secure access to equitable health services for populations of migrants can be difficult. these difficulties can exist even in nations with long-standing immigration programs. for nations that have only recently begun to deal with the growing dynamics of international migration, the difficulties can be much greater. professional and population education, training, and orientation to societal values in health promotion and maintenance, disease prevention, and health services utilization also take time and commitment to achieve. new and evolving populations of migrants and mobile populations can result in rapid arrival and growth of large communities with diverse characteristics, which include social, linguistic, cultural, and economic status; these can be associated with disparate health outcomes. access to and utilization of health and medical services by some foreignborn communities may have a different pattern than those of the host population. , specialized services encompassing linguistically and culturally competent providers, designed for the problems of migrants, will be required to ensure adequate health-care programs and service delivery models. similar features may need to be integrated into public health and disease-control programs designed to mitigate health threats or risks. this is reflected in the need to have educational and instructional information prepared in the language of migrants at an appropriate level for comprehension, and the need for translation or visual tools to deliver messages in a culturally appropriate manner. depending on the location and health sector capacities, these forces can affect the design and function of the health program. migrant-specific programs may be more effective for the migrant community, but they may engender additional costs and resource demands. additional challenges occur as a result of migrant diversity itself and can be seen in many locations where demands or needs for culturally competent health services can extend across several nationalities and ethnicities. strategies to deal with these situations include ( ) support for acculturalization and integration to allow migrants to better use domestic medical and health services and ( ) the provision of migrant-specific or migrant-friendly health services. national, regional, and municipal differences in migrant history and demography make it unlikely that a single approach will be applicable to all venues. however, modern information technology and networking does provide opportunities for the sharing and exchange of best practices and information across cultural environments. , the legal or administrative status of the migrant does affect access to services and care. migrants in an unauthorized situation and some foreign-born women have been shown to have a lower utilization of health services than the local population. for example, health services may be too costly for migrants who do not have health insurance coverage. although linguistically appropriate health services are available and affordable, they may not be used because of migrants' lack of information about their rights and entitlements or out of fear for deportation. limitations to traditional responses to the health challenges of migration traditional approaches to health and migration frequently deal with specific diseases, primarily communicable diseases of public health significance that may be associated with the arrival of migrants. , coordinated attempts at the international level to manage infectious disease transmission were organized and consolidated into the international health regulations (ihr), which was revised in . some nations with integrated and long-standing immigration programs have systematically screened applicants for permanent residency status (immigrants) and some other classes of mobile populations (such as temporary resident applicants, including foreign students or migrant workers ), for various health conditions and illnesses. immigration medical screening, quarantine, and isolation have been used in attempts to address the possible introduction of health threats by exclusion. major immigration-receiving nations continue to use these processes to reduce the impact of health disparities in arriving mobile populations. important as they are from a legal and administrative perspective, programs and policies that continue to embrace responses of inspection and exclusion will be increasingly costly and ineffective in the context of modern migration and population mobility. furthermore, attempting to manage or mitigate health risks in arriving travelers, when many of the health risks may be latent or subclinical, without affecting international travel and commerce is operationally and logistically impractical. modern migration is an integral component of the broader process of globalization and is intimately linked to other nonhealth aspects of globalization, such as global trade and economics, safety and security, and environmental and climatic changes. population mobility underpins the labor and economic demands for human capital. it also helps mitigate the social, demographic, and economic impacts of aging populations in many economically advanced nations where increased migration is required to sustain labor markets and population growth. in addition, modern migration is greater in magnitude and more diverse in health demographics than the traditional immigration process. at present, many people migrate temporarily or travel back and forth between their community of origin and their destination. as international migration will be an increasingly important aspect of human activity, improving the health of migrants and reducing adverse health outcomes related to migration can be expected to be a growing concern globally. some migrant-receiving nations are beginning to appreciate the impact of chronic illnesses in migrants. this includes the demand on and the use of health and medical services by foreign-born populations, and the impact of lifestyle and behavioral factors on health and the health sector. [ ] [ ] [ ] [ ] [ ] standardized approaches to manage health implications associated with population mobility have been proposed, which extend beyond traditional immigration administrative processes to encompass an integrated health framework for modern population mobility (see table ). managing health threats, risks, and challenges in a global context the need for modern and global approaches to population mobility and health is not an abstract goal. considerable attention in the field of migrant health is devoted to the investigation and improved documentation of health indicators among migrant populations in receiving nations. however, many of the health threats, risks, and challenges related to health outcomes due to migration result from factors and influences present outside the jurisdiction and hence the direct influence, of the migrant-receiving nations. , even in nations where long-standing immigration programs are a component of national policies, the health aspects of migration may not be addressed systematically and much of the attention toward migrant health issues is only national in scope. some regional strategies have been proposed, but analysis suggests that they may not be evenly applied or supported. , as a result, there is a paucity of systematic programs and policies to support the health of migrants. to improve global health management and preventive health practices, there is a need for coordinated international actions and partnerships between governments and organizations in nations of origin, transit, and destination. studies have suggested that primary health prevention endeavors such as tuberculosis control in countries of migrant origin are more economical over the longer term than traditional immigration screening programs and policies. they address better universal access in support of equity and the right to health, and have secondary preventive benefits manifested through the improvement of health indicators in migrant source countries. there is growing interest in and appreciation of efforts to address the importance of health and migration at the global level. in , the who world health assembly resolved to take on the issue through its member states by adopting a resolution on migrant health. approaching the topic through coordinated, international action will require considerable changes in many current national and regional health strategies and disease-control policies. national programs based on immigration status, nationality, historical roles of national borders, and traditional travel patterns will need to be redesigned to allow for equitable access to health services for migrants, and greater exchange of information and data to improve research into migrants' health. threats, risks, and challenges will need to be conceptualized in terms of mobility and population dynamics, and to consider migrant origin and transit practices. developing multisectoral approaches the health of migrants is intrinsically linked to all determinants of health but particularly to the unequal distribution of socioeconomic determinants, including income status, housing and accommodation, education, nutrition, sanitation, and employment. , as a consequence, societal responses will be most effective if they are multidisciplinary and involve stakeholders from all relevant sectors working together to reduce adverse outcomes and improve the health of migrants. international dialogue and activities in the field of migration are centered around the principles and policies of more effectively managing migration for the benefit of origin and recipient nations. sustaining and improving the health of migrants is a lateral issue that must be integrated into all aspects of migration management. this implies integrating migration into health policies and strategies that are directly related to desired health outcomes. it implies an increasing awareness among health-care providers and educators, as well as migration policy makers on how to address health threats, risks, and challenges associated with or resulting from population mobility and disparities in health services between geographical locations. a systematic approach to managing adverse migration health outcomes must reflect and integrate the several patchwork policies that have been evolving in many nations for more than a century to deal with situational aspects of migration. at present, various policies exist that address issues related to the health of trafficked and smuggled migrants, labor migrants, those traveling for medical and religious reasons, and for those applying for formal immigration. other broader policy instruments deal with aspects of health for bona fide refugees and asylum seekers or refugee claimants, detained and incarcerated migrants, and for those being returned or deported. integrated health policies that respect the rights of migrants will greatly facilitate coordinated approaches. these must be based on standardized international terminologies and principles reflecting the tools of the un, international organizations, and national programs. systematic actions that support migrant health improvement access to health services, and those that address the specific vulnerabilities of certain migrant populations, will assist nations in developing programs to meet current and future demands. these measures are in the global and national public health interest of sending and receiving communities from a social equity and equality perspective. prioritized programs to reduce disparities responsible for the greatest health risks several of the adverse health outcomes related to migration, particularly those associated with infectious diseases, are already the subject of international and in some cases global attention. many of these diseases are being addressed through initiatives that involve international and regional programs dedicated to improving global health. they include international efforts to expand immunization (gavi), reduce the impact of high-burden diseases (such as tuberculosis, hiv/aids, and malaria), manage the implications of pandemic influenza, and improve public health responses in general (ihrs). although migration and population mobility may feature in some aspects of these endeavors, there is a paucity of integrated collective action on migration-associated components. integrating a migration component into these activities can facilitate the global approach to disease control and demonstrate immediate benefit for both source and recipient nations. mobile populations are one of the means by which locally arising risks can become global challenges. mitigation programs and control strategies must encompass migration components in terms of both threat-to-risk assessment and intervention planning. the importance of these issues has been noted during responses to global health events such as sars ( ) and the more recent pandemic influenza ( ) event, wherein travel-related control measures included screening, inspection, isolation, quarantine, and exclusion. the scale of migration and population mobility has required many of these responses to have cultural and linguistically appropriate services. to be effective, such programs need to reflect the ongoing health impacts of migration that extend well beyond the 'immigration' process. a relatively new phenomenon in international population mobility is the number of migrants who, greatly facilitated by modern travel industry, return to their place of origin to visit relatives or friends; they are known as vfr (visiting friends and relatives) travelers. vfr travelers typically take longer trips, stay in local homes or accommodations, eat locally prepared meals, and take fewer pretravel precautions. many vfr travelers return to their country of origin with children who were born at the new place of residence and lack the immunity their parents acquired before migration. these migrant-related populations of vfr travelers have been identified as being associated with increased adverse health outcomes. , education and training in health and migration processes of migration and population mobility have complex ethical, legal, administrative, and social components that relate to the health of the migrant and host communities. studies have shown that the lack of familiarity with migrant health conditions or the nature of health determinants in migrant communities can negatively affect the effectiveness of care. better understanding of the nature of the health aspects of migration can prevent some adverse health outcomes in international migrants through activities that support the early detection and treatment of health problems in these populations. this is accomplished through early access to and availability and affordability of health care for newly arriving migrants. minimum standards for the provision of linguistically and culturally appropriate tools that assist in health-care delivery , are emerging health-system requirements in some nations. as the world becomes increasingly mobile, multicultural health-care providers in many locations will need to acquire greater capacity to understand, study, and address health needs of migrant communities. migration and international population mobility are facts of global life. the volume of mobile populations within and beyond national boundaries is bringing increasingly high numbers of diverse and disparate populations together. this may occur in areas where traditional administrative approaches to managing migration processes cannot address the health-care needs of migrant populations nor the impacts that these populations may have on transit, recipient, and home communities. addressing the health needs of migrants improves migrant health, avoids stigmatization and marginalization, may reduce long-term health and social costs, protects global public health, facilitates integration, and contributes to social and economic cohesion and development. this paper posits that many of the health challenges associated with modern migration have their origins in the international and global extension of inter-regional disparities in health indicators and determinants. mobile populations provide population bridges across these gaps in health indicators, and effectively globalize risks and negative health outcomes. national and international policies and programs reflecting existing geo-political boundaries represent traditional approaches to dealing with health and migration but are becoming progressively ineffective in the face of migration that is growing in volume and diversity, while extending across locations with disparate health determinants and outcomes. related to specific migrant populations or individual diseases and varying between nations, these traditional administrative approaches may not represent the most effective methods and means of meeting the current or future needs of an increasingly diverse and globalized population. the recent resolution by the who world health assembly reflects the growing international recognition of the importance of the health effects of modern population mobility. addressing migration health needs through a global lens will be best achieved with regional and global strategies that consider public health aspects previously considered to be limited to national needs. policies, programs, and health services for migrants may still be prepared and delivered at a local and national level, but they should be based on and reflect international and global principles and standards. systematic and integrated approaches to migration health, based on global processes and migrants' rights, represent an effective method of managing these issues. globalization: people, perspectives, and progress modernity at large: cultural dimensions of globalization globalization and health: a critical appraisal the signature features of 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organization department of economic and social affairs, population division. international migration vision -forecasting international student mobility a uk perspective towards a fair deal for migrant workers in the global economy office to monitor and combat trafficking in persons trafficking in persons report the opinions expressed in this paper are entirely those of the authors and do not necessarily reflect or represent the positions of any organization to which the authors have been or are currently associated. key: cord- - hu so authors: marsch, lisa a. title: digital health data-driven approaches to understand human behavior date: - - journal: neuropsychopharmacology doi: . /s - - - sha: doc_id: cord_uid: hu so advances in digital technologies and data analytics have created unparalleled opportunities to assess and modify health behavior and thus accelerate the ability of science to understand and contribute to improved health behavior and health outcomes. digital health data capture the richness and granularity of individuals’ behavior, the confluence of factors that impact behavior in the moment, and the within-individual evolution of behavior over time. these data may contribute to discovery science by revealing digital markers of health/risk behavior as well as translational science by informing personalized and timely models of intervention delivery. and they may help inform diagnostic classification of clinically problematic behavior and the clinical trajectories of diagnosable disorders over time. this manuscript provides a review of the state of the science of digital health data-driven approaches to understanding human behavior. it reviews methods of digital health assessment and sources of digital health data. it provides a synthesis of the scientific literature evaluating how digitally derived empirical data can inform our understanding of health behavior, with a particular focus on understanding the assessment, diagnosis and clinical trajectories of psychiatric disorders. and, it concludes with a discussion of future directions and timely opportunities in this line of research and its clinical application. overview and limitations of theoretical models of human behavior and diagnostic models of psychiatric disorders human behavior is one of the biggest drivers of health and wellness as well as mortality and morbidity. indeed, health risk behavior, including poor diet, physical inactivity, tobacco, alcohol, and other substance use, causes as much as % of the illness, suffering, and early death related to chronic diseases [ ] [ ] [ ] . health risk behavior is linked to obesity, type diabetes [ ] , heart disease, liver disease, kidney failure, and neurological diseases. it is also linked to many mental health disorders including anxiety and depression [ , ] . and it greatly increases one's risk for a wide variety of cancers. for example, heavy alcohol use greatly increases risk of breast [ ] [ ] [ ] , esophageal, and upper [ ] digestive and liver cancers [ , ] . smoking is strongly linked to lung cancer and is also a major contributor to esophageal cancer [ ] [ ] [ ] [ ] . and, obesity increases risk of colorectal and esophageal cancer [ ] [ ] [ ] . research designed to explain and predict health behavior and events influencing health outcomes has heavily relied on theoretical models of health behavior and behavior change [ , ] . at the psychological level, the cognitive literature has focused on such performance-related processes as goal maintenance in working memory, impulsivity, and cognitive homeostasis. the affective science and social psychology literatures have focused on emotion regulation processes, social influences and resource models. in parallel, the health psychology and behavioral medicine literatures have focused on processes, such as self-efficacy and outcome expectancies. at the behavioral level, focus has been largely placed on behavioral disinhibition and temporal discounting. at the neural level [ ] , health behavior can be conceptualized in terms of top-down control (implemented by fronto-parietal networks) over impulsive drives or habits (implemented by subcortical and ventromedial prefrontal regions [ ] ). and an emerging framework from neuroeconomics has characterized decision processes in terms of goal-directed versus habitual or pavlovian control over action [ ] [ ] [ ] . overall, these models afford a conceptual framework for illustrating causal processes of key constructs hypothesized to influence or change a target behavior. theoretical models may be useful for developing, implementing, and evaluating behavior change interventions. and, interventions informed by theories of human behavior are generally more effective compared with those that are not [ ] . collectively, various theoretical models have articulated that an individual's beliefs and attitudes, behavior intentions, level of motivation for behavior change, and social and cognitive processes impact health behavior [ ] . despite the promise of theoretical models of health behavior, their ability to explain and predict health behavior has been only modestly successful [ ] [ ] [ ] . many theoretical models have regarded human behavior as linear or static in nature and have not recognized that behavior is dynamic and responsive to diverse social, biological, and environmental contexts. and, theoretical models have heavily focused on between-person differences in behavior and have not embraced the study of important withinperson differences in behavior. further, many theoretical models of health behavior and behavior change have often been derived within siloed disciplines (e.g., health psychology, neuroscience) with little crosstalk [ , ] . in addition, research examining factors that influence health behavior has tended to examine a small set of potential moderators or mediators of health behavior at a specific level of analysis (e.g., emotion regulation alone or impulsivity alone) and may lead to over-simplified accounts of behavior [ ] [ ] [ ] [ ] change. finally, little research has established the temporal precedence of a broad array of potential factors impacting health behavior [ ] . more frequent and longer assessment of moderators, mediators, and outcome(s) will be necessary to elucidate the temporal dynamics between changes in specific mechanisms [ ] and behavior [ , ] . similar limitations are evident in our current models for understanding and determining clinical diagnoses for psychological or psychiatric disorders. the current process for identifying diagnosable disorders heavily relies on measuring the number and type of symptoms that a person may be experiencing as well as associated distress or impairment. although this current diagnostic process provides a useful common language of mental disorders for clinicians, the process is largely based on consensus from expert panels and may oversimplify our understanding of human behavior [ ] . and indeed, many mental health clinicians do not measure behavior, cognition, and emotion when ascribing a psychiatric disorder to a patient. further, mental health professionals usually interact with, and provide diagnoses to, patients at a specific moment in patients' lives, but recent evidence shows that people with psychological disorders may experience many different kinds of disorders across diagnostics families over their lifespan [ ] . there is tremendous opportunity to understand psychological/biological systems that span the full range of human behavior from normal to abnormal and to empirically assess how they are situated in environmental and neurodevelopmental contexts [ ] . examining a broad array of factors impacting health behavior at multiple levels of empirical analysis and over time will enable a more comprehensive picture of health behavior and will increase our ability to develop more impactful interventions and better understand the conditions under which replications of effects do and do not occur. advances in digital technologies and data analytics have created unparalleled opportunities to assess and modify health behavior and thus accelerate the ability of science to understand and contribute to improved health behavior and health outcomes. digital health refers to the use of data captured via digital technology to measure individuals' health behavior in daily life and to provide digital therapeutic tools accessible anytime and anywhere [ , ] . for example, smartphones have an array of native sensors including bluetooth, gps, light sensor, accelerometer, microphone, and proximity sensors as well as systems logs of calls, and short message service use. smartphones, as well as some wearable devices (e.g., smartwatches), thus enable passive, ecological sensing of behavioral, and physiological features, such as one's sleep, physical activity, social interactions, electrodermal activity, and cardiac activity [ ] . individuals can also offer responses to questions they are prompted to answer on mobile devices (sometimes called "ecological momentary assessment" or ema) to provide snapshots into, for example, their context, social interactions, stress, pain, mood, eating, physical activity, mental health symptoms, and substance use. and, social media data, that many individuals produce in high volume, provide information about individuals' behavior, preferences, and social networks. these "digital exhaust" [ ] data or "digital footprints" [ ] enable the continuous measurement of individuals' behavior and physiology in naturalistic settings. these digital data may greatly complement and extend traditional sources of clinical data (which is typically captured on an episodic basis in a clinical context) with intensive, longitudinal ecologically valid data. digital health data capture the richness and granularity of individuals' behavior, the confluence of factors that impact behavior in the moment, and the within-individual evolution of behavior over time. as such, they may contribute to discovery science by revealing digital markers of health and risk behavior [ , ] . they may help us to better develop empirically based diagnostic classifications of aberrant/dysfunctional behavior and the clinical trajectories of diagnosable disorders over time [ ] . and, they may help us in translational science by informing more personalized, biomarker-informed, and timely models of intervention delivery. as the majority of the world has access to digital technologyindeed, there are billion mobile phone subscriptions worldwide [ ] -digital health data-driven approaches can be used to understand human behavior across the population. this manuscript provides a review of the state of the science of digital health data-driven approaches to understanding human behavior. the manuscript first describes various methods of digital health assessment and sources of digital health data. it then provides a synthesis of the scientific literature evaluating how digitally derived empirical data can inform our understanding of health and risk behavior. it then focuses on how digital health may help us to develop a better empirically based understanding in the assessment, diagnosis, and measurement of clinical trajectories of aberrant/dysfunctional disorders in the field of psychiatry (a field that has led pioneering research in digital health [ ] ). finally, it concludes with a discussion of future directions and timely opportunities in this line of research and its clinical application, including the development of personalized digital interventions (e.g., behavior change interventions) informed by digital health assessment. digital health assessment methods although digitally derived data have been used to understand behavior and context in the field of computer science for over years, a primary term currently used to capture digital health assessment is "digital phenotyping" [ ] and is increasingly used by scientists, funders, as well as the popular press. digital phenotyping [ ] primarily employs passively sensed data to allow for a moment-by-moment (in situ) quantification of behavior. these data can include data derived from smartphone or smartwatch sensors (e.g., an individual's activity, location), features of voice and speech data collected by mobile devices (e.g., prosody and sentiment), as well as data that captures a person's interaction with their mobile device (e.g., patterns of typing or scrolling). digital phenotyping largely employs passive data (to reduce burden to participants in data collection), and some researchers confine their definition of digital phenotyping to passive data. however, digital measurement and analytics also encompass many other sources of data that are actively generated by individuals, including social media data, ema data, and online search engine activity. overall, digital phenotyping focuses on the use of such digital data to understand and predict health outcomes of behaviors of interest. sophisticated inferences from these data are increasingly possible due to the rapidly advancing fields of big-data analytics and advanced artificial intelligence (including advanced machine learning approaches that focus on the creation of systems that learn from data instead of simply following programmed instructions). behavioral health systems that leverage passive sensing and machine learning to learn and adapt to a person's actual behavior and surroundings offer a promising foundation for predictive modeling of an individual's behavioral health trajectory and may support new breakthrough intervention technologies targeting health behavior. these developments enable behavioral monitoring to occur in the background as individuals go about their lives and build dynamic computational models tailored to the user that can lead to effective interventions. and digital phenotyping may reveal new insights into how other data sources (such as genetic, molecular and neural circuitry data) interrelate with clinically observable psychopathology [ , ] . overview of the scientific literature on the application of digitally derived empirical data to understand health behavior and psychopathology a robust and rapidly growing scientific literature is increasingly demonstrating the potential utility of digital assessment in revealing new insights into human behavior, including psychological and psychiatric disorders. digital health biomarkers of health and risk behavior captured via mobile technology. continuous smartphone sensing (e.g., of activity, mobility, sleep) has been shown to be significantly linked to mental well-being, academic performance (grade point average), and behavioral trends of a college student body, such as increased stress, reduced sleep, and reduced affect as the college term progresses and stress increases [ ] . these patterns may help us to understand, in close to real time, when individuals may be at risk of academic and/or mental health decline. assessment of individual's interactions with mobile devices (e.g., swipes, taps and keystroke events) have been shown to capture neurocognitive function in the real world and may provide an ecological surrogate for laboratory-based neuropsychological assessment [ ] . and, continuous smartphone monitoring can measure brain health and cognitive impairment in daily life [ ] . and, digital data derived from mobile sensing (e.g., calling, texting, conversation and app use) have also been used to characterize behavioral sociability patterns and to map these behaviors onto personality traits [ ] . further, phenotypic data gathered via wearable sensors have shown that several metrics of sleep (total sleep time and sleep efficiency) are associated with cardiovascular disease risk markers, such as waist circumference and [ ] body mass index and that insufficient sleep is linked to premature telomere attrition. thus, these digitally derived health risk data can provide real time insights into biological aging. digital health measurement of aberrant/dysfunctional behavior and the clinical trajectories of diagnosable disorders over time captured via mobile technology. digital assessment has also illuminated novel insights into the nature and course of psychological and psychiatric disorders. high-frequency assessment of cognition and mood via wearable devices among persons with major depressive disorder has been shown to be feasible and valid over an extended period [ ] . behavioral indicators passively collected through a mobile sensing platform (e.g., the sum of outgoing calls, a count of unique numbers texted, the dynamic variation of voice, speaking rate) have been shown to predict symptoms of depression and ptsd [ ] . features derived from gps data collected via phone sensors, including location variance, entropy, and circadian movement, have been shown to predict severity of depressive symptoms and that these relationships can differ at different points in time (e.g., weekend vs. weekday [ ] ). and assessment of voice data has identified vocal acoustic biomarkers that have shown promise in predicting treatment response among persons with depression [ ] . movement data from actigraphs alone, a single measure of gross motor activity from a sensor worn on the wrist, were able to identify the diagnostic group status of individuals with major depression or bipolar vs. healthy controls % of the time. this level of accuracy in diagnostic classification is greater than published inter-reliability rates for second raters using the structured clinical interview for the dsm (scid). and results showed that actigraphy data predicted the majority of variation in patients' depression severity over an~ -week period [ ] . emotion dynamics captured over time via digital technology have been shown to differentially predict bipolar and depressive symptoms concurrently and prospectively [ ] . and, ema data captured on smartphones has been shown to predict future mood among persons with bipolar disorder [ ] . in addition, smartphone usage patterns have been shown to be linked to functional brain activity related to depression. for example, phone unlock duration has been shown to be positively linked to resting-state functional connectivity between the subgenual cingulate cortex (an area understood to be involved in depression) and the ventromedial/ orbitofrontal cortex [ ] . results suggest that digital biomarker data may reflect readily capturable data that relate to brain functioning. further, a small pilot study evaluated changes in mobility patterns and social behavior among persons diagnosed with schizophrenia using passively collected smartphone data. results indicated that the rate of behavioral anomalies that were identified in the weeks prior to a clinical relapse were markedly higher ( %) than rates of behavioral anomalies during other periods of time [ ] . and, other research has underscored the significant variability across individuals in digital indicators of a psychotic relapse [ ] thus underscoring the multi-dimensional nature of a diagnosis of a psychotic disorder. in addition, a small series of case studies demonstrated that selfreported psychotic symptoms are linked to various behaviors (cognition scores on games) and activity levels (step count) among persons with psychotic illness. importantly, results revealed considerable variability in the patterns in these data streams across individuals, underscoring the utility of these approaches in understanding and monitoring within-individual clinical trajectories [ ] . and other research has demonstrated that decreased variability in physical activity and noisy conditions on an inpatient psychiatric unit, captured via multimodal measurement, is associated with violent ideation among inpatients with serious mental illness [ ] . assessment of geography via passive sensing of geolocation using gps has demonstrated that drug craving, stress, and mood among persons with an opioid use disorder were predicted by exposure to visible signs of environmental disorder along a gpsderived [ , ] track (such as visible signs of poverty, violence, and drug activity). a recent digital health ema study demonstrated a stronger link between drug craving and drug use than between stress and drug use-a result that was not well-documented or understood from prior traditional clinical assessment [ ] . and, among smokers trying to quit, lapses to smoking were shown to be associated with increases in negative mood for many days (and not just hours) before a smoking lapse [ ] . these studies reveal new insights into the dynamic nature of drug use events and the confluence of factors that impact them. unfortunately, only a few studies have included randomized controlled evaluations of the clinical utility of digital phenotyping in the clinical treatment of psychological disorders. among these studies, one recent, controlled study that investigated the effect of smartphone monitoring of persons with bipolar disorder did not show a statistically significant benefit on depressive or manic symptoms compared with a control group, although persons with smartphone monitoring reported higher quality of life and lower stress [ , ] . digital health measurement of health behavior captured via additional (non-mobile) data sources. in addition to data captured via mobile devices, other sources of digital data have been shown to reveal insights into human behavior. for example, social media data have provided new insights into mental health and substance use behavior. in one study, a deep-learning method was able to identify individuals' risk for substance use using content from their instagram profiles [ ] . and another evaluation demonstrated that community-generated instagram data (post captions and comments from friends or followers), when evaluated along with user-generated content (individuals' post captions and comments), were able to identify depression among individuals. other work has also demonstrated that facebook status updates can predict postpartum depression [ ] and that depression can be identified via daily variation in word sentiment analysis among twitter and facebook users [ , ] . such methods offer promise for conducting population-level risk assessments and inform population-level interventions [ ] . data from online search engine activities are another source of consumer-generated digital data that can reveal individual-level as well as population-level behavioral patterns. for example, online health-seeking behavior has been shown to predict real-world healthcare utilization [ ] . online search activity has been shown to be related to changes in use of new substances [ ] , and substance use search data have been strongly correlated with overdose deaths [ ] . and, a recent study analyzed over million google search queries across the united state related to mental health during the covid- global pandemic. results revealed that mental health search queries increased rapidly prior to the issuance of stay-athome order within states, and these searches markedly decreased after the announcement and implementation of these orders, presumably once a response/management plan was in place [ ] . overall, the existing scientific literature demonstrates a compelling "proof of concept" that digital health data can provide new insights into human behavior, including psychopathology. this line of research offers great promise for advancing our theoretical models of health behavior and informing behavior change interventions that are responsive to the dynamic nature of health behavior. the promise of digital health is particularly compelling when applied to the field of psychiatry. digital assessment allows for the continuous, empirical quantification of clinically useful digital biomarkers that can be useful in identifying and refining diagnostic processes over time. these data may also be useful as outcomes in measurement-based care. these data may help us to generate predictive models that reflect the confluence of factors, and their relations over time, that may inform when an individual may be at risk for a clinically significant event (such as a relapse or psychotic event). these methods may help detect a problem before it occurs and inform in-the-moment preventative interventions. and, given that psychiatric conditions are often chronic and recurrent, digital data captured in an intensive longitudinal manner can inform strategies for optimizing responsive and adaptive models of clinical care over time. thus, digital health offers value along a full spectrum from measurement to intervention delivery-by providing novel digital biomarkers, new insights into clinical diagnoses of psychiatric disorders, personalized intervention delivery on digital platforms, as well as digital outcome measurement over time. these multiple applications of digital health can complement one another by measuring behavior and informing interventions that are responsive to that measurement. despite the promise of digital health data-driven approaches to understanding human behavior, there remain many gaps and opportunities in the field. as noted above, most digital health research has not embraced rigorous experimental research designs. indeed, only a paucity of trials has embraced well-powered, randomized, controlled research designs to allow for causal inference about the value of digital assessment and associated data analytics in informing clinical outcomes [ ] . in addition, tremendous variability exists in the specific digital metrics being employed in digital health research-ranging from smartphone sensing data, smartwatch sensing data, ema data, social media data, and online search engine data. and within each of these categories, there is also great variability in the types of features that are being extracted and applied to clinical inference. for example, in smartphone sensing alone, some research focuses heavily on gps, other work focuses on actigraphy, while still other research focuses on movement. the specific features and sources of digital health data (including the potential combination of multiple sources of digital data) that provide maximal precision in characterizing human behavior and behavioral disorders remain understudied as do the psychometric characteristics (e.g., validity and reliability) of such metrics [ ] . in order to realize the potential of digital health and provide the most robust and replicable results, a priority focus on experimental rigor and reproducibility is critically needed. in addition, digital health research to date has been conducted within our existing classification systems (e.g., patients with bipolar disorder or depression) which, as noted above, can be refined with digital health approaches. and most digital health research has been focused on disease-specific models (e.g., focusing on depression alone or substance use alone). the rich, granular data afforded by digital health approaches offer tremendous opportunity to transcend siloed disease-specific models of behavior and care to empirically embrace, understand, and treat the complexity and interrelatedness of behavioral patterns and clinical disorders. indeed, scientific research has demonstrated that many disorders co-occur and interrelate in meaningful ways and that these disorders evolve and change over the lifespan. digital health offers great (but yet unrealized) promise to provide a data-informed understanding of this full spectrum of health and wellness. this may include the development of an ontology of behavior that is informed by digital health data, which may enable a new understanding of co-occurring aberrant/dysfunctional behaviors and their evolution over time. and this may include digital therapeutic interventions that are responsive to the combination of needs and goals of each individual and their evolution over time. finally, much of the current research appears to ground in assumptions that digital health data will be of interest and of value to consumers, patients, and clinicians. although one could make the case that patients may value self-monitoring and feedback on their behavior and their clinical status and that clinicians may welcome actionable digital health data that can aid them in the care of patients, this may not always be the case. for example, if patients do not experience value in generating and sharing these data, they will not be inclined to do so (or to do so for any extended period of time). if providers receive large volumes of unsolicited data and/or data that do not directly inform their clinical work, they may perceive such a model to be burdensome and unhelpful. and if patients do not understand the privacy and security considerations of how their sensitive data will be handled and/or if healthcare systems do not understand data sharing/protection policies of industry vendors, this will undoubtedly impact adoption [ ] . indeed, it is possible that the current scientific literature largely reflects a subset of the population that are willing to share personal health data collected on digital devices, which may not be broadly generalizable. a broader dialog is needed to establish fundamental principles of privacy and research ethics in the digital health space. this may include establishing best practices for ensuring protections of patient privacy and sensitive information while still allowing for data to be shared between parties (e.g., patients and clinicians) in accordance with patient and provider preferences. and, this may include informed consent processes that are adaptive and dynamic in response to each individual's digital literacy and data sharing preferences [ ] . overall, as research and clinical application of digital measurement of behavior expands, there is an urgent need to ensure that implementation science approaches are employed to systematically assess the preferences of all the relevant digital health stakeholders and to inform models of development and deployment that have the greatest chance of scalability and sustainability. this will undoubtedly require an interdisciplinary effort across the scientific arena (including behavioral science, data science, computer science and neuroscience) as well as the digital health industry and experts in public policy. digital health and data analytics are transforming our world. and, the real-world precision assessment that digital health methods enable are providing unprecedented insights into human behavior and psychiatric disorders and can inform interventions that are personalizable and adaptive to individuals' changing needs and preferences over time. now is the moment of opportunity to embrace a systematic, rigorous, and comprehensive research agenda to realize this vision. research 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considerations when sharing individual-level research data open access this article is licensed under a creative commons attribution . international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons license, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons license, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this license, visit http://creativecommons. org/licenses/by/ . /. key: cord- -hvrly e authors: stanton, robert; to, quyen g.; khalesi, saman; williams, susan l.; alley, stephanie j.; thwaite, tanya l.; fenning, andrew s.; vandelanotte, corneel title: depression, anxiety and stress during covid- : associations with changes in physical activity, sleep, tobacco and alcohol use in australian adults date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: hvrly e the novel coronavirus (covid- ) has enforced dramatic changes to daily living including economic and health impacts. evidence for the impact of these changes on our physical and mental health and health behaviors is limited. we examined the associations between psychological distress and changes in selected health behaviors since the onset of covid- in australia. an online survey was distributed in april and included measures of depression, anxiety, stress, physical activity, sleep, alcohol intake and cigarette smoking. the survey was completed by adults (mean age . ± . years, % female). negative change was reported for physical activity ( . %), sleep ( . %), alcohol ( . %) and smoking ( . %) since the onset of the covid- pandemic. significantly higher scores in one or more psychological distress states were found for females, and those not in a relationship, in the lowest income category, aged – years, or with a chronic illness. negative changes in physical activity, sleep, smoking and alcohol intake were associated with higher depression, anxiety and stress symptoms. health-promotion strategies directed at adopting or maintaining positive health-related behaviors should be utilized to address increases in psychological distress during the pandemic. ongoing evaluation of the impact of lifestyle changes associated with the pandemic is needed. first reported in november , the novel coronavirus (covid- ) has resulted in a global health emergency. as of june , the virus has claimed more than , lives globally and infected more than . million people. the scale of the pandemic has resulted in worldwide concern, not only for the loss of life but also the social and economic impacts. there is significant concern over how the changes in the ways that people normally engage in everyday activities impact their health and well-being. this is especially relevant for those in self-isolation or quarantine, where feelings of depression, fear, guilt, and anger may manifest [ ] . in australia, similar to other countries, social distancing, travel bans, the cancellation of sporting and other mass participation events, and changes to work practices have dramatically affected daily life. the partial lockdown procedures implemented by the australian government to protect citizens and reduce the spread of the virus forced the closure of many businesses in late march saw unemployment levels rise to . %, more than three times higher than the pre-covid- predicted unemployment rate [ ] . the impact of these changes likely comes at significant personal cost, including the onset, or worsening, of mental health issues. to address the psychological distress experienced by australians in the current pandemic, more than aud million has been committed to the development and delivery of mental health and well-being support services in australia. multiple calls to ensure the preparedness of psychological services have been presented [ ] [ ] [ ] ; however, the uptake and immediate and long-term impacts of these services are unclear. the covid- pandemic may also lead to adverse changes in health behaviors, such as physical activity, smoking, alcohol use and sleep. with the enactment of social isolation and physical distancing restrictions in march , the usual places to be physically active, such as gyms and outdoor recreation facilities, were no longer accessible. although some people may have sufficient autonomous regulation of physical activity to pursue alternate activities (e.g., online fitness classes, other home-based physical activities), others may reduce their physical activity due to the lack of social support available or concerns for contracting the virus in an outdoor environment. on the other hand, those forced to work from home may have spent less time commuting, and may have seized the opportunity to create new physical activity habits. alternatively, since exercise was one of few legitimate reasons for being able to leave the home some people may have developed a walking or cycling habit as a reason to escape being housebound. as many studies have demonstrated strong positive associations between physical activity and lower psychological distress [ , ] , the commencement or continuation of physical activity during the pandemic will likely aid in reducing psychological distress. however, some concern has been expressed regarding increased risk of respiratory illness in those engaged in high-and very-high intensity exercise due to the potential for reduced immune response [ ] . in contrast to health-promoting behavior such as physical activity, some people may manage social isolation and any pandemic-related psychological distress by commencing or increasing adverse health behaviors such as smoking or alcohol use. since covid- is an acute respiratory illness, commencement or continuation of tobacco use during the covid- pandemic may lead to the worsening of outcomes for those infected with the virus [ ] . indeed, early indications suggest the proportion of current and former smokers is higher among those with severe disease and among those admitted to intensive care and requiring ventilation [ , ] . harmful intake of alcohol leads to neuroadaptations that exacerbate alcohol cravings during times of stress [ ] . hence, social isolation, coupled with changes in employment status or uncertainty about the future may trigger an increase in alcohol intake for susceptible individuals [ ] . the combined effect of changes in lifestyle behaviors; confinement to the home through government restrictions in travel; and elevated depression, anxiety and stress associated with the current covid- pandemic, may have significant negative impacts on sleep [ ] . this has been especially evident in healthcare workers, who may be required to work longer shifts in highly stressful environments [ , ] . poorer sleep quality has been associated with higher levels of depression, stress, and anxiety [ ] . maintaining sleep quality is important in strengthening immunity [ ] , hence any sleep disturbances subsequent to covid- -pandemic-induced stress, may increase susceptibility to infection, or compromise recovery in the case of infection [ ] . there is currently limited research regarding psychological distress subsequent to the covid- pandemic. two recent studies from china reported high levels of psychological distress during the initial stages of the pandemic [ , ] ; however, the association between psychological distress and health behaviors remains unclear. early evidence during the covid- outbreak suggests positive associations between increased physical activity and physical health and inverse associations between sedentary behavior and physical and mental health outcomes [ ] . a more detailed exploration of health behaviors during stages of the covid- pandemic may help direct future public health messaging to promote positive behaviors and guard against uptake or the worsening of negative behaviors in order to maintain community well-being and mental health. therefore, the present study aims to examine associations between depression, anxiety and stress and changes in health behaviors, including physical activity, sleep, smoking and alcohol use subsequent to the onset of covid- and the implementation of social isolation rules in australia. an anonymous online survey was hosted on the survey platform qualtrics and distributed using social media sources (facebook and twitter) and via institutional sources including email and public marketing. eligible participants included all australian adults aged years and over. ethical approval was granted by central queensland university's human research ethics committee (approval number ). data collection occurred between and april . at the time of survey distribution, australia was in the midst of significant personal distancing, partial lockdown and travel restrictions. social distancing measures included keeping a minimum . meters between people, a ban on any public gatherings, a limit of no more than five people at personal gatherings such as weddings and funerals, and no person was allowed to meet with more than one other person outside of their own household. lockdown restrictions also included the closure of restaurants and bars, many retail stores, and restricted access to outdoor parks. most schools were closed, with students advised to study from home while being supported by online learning platforms and materials. university campuses limited or ceased face-to-face teaching and transitioned to online learning, with most clinical placements, residential schools, and simulations postponed. inter-and intra-state travel was banned, and travel within towns and cities was only permitted for essential work/workers, or to access essential services such as medical or health care, or to shop for groceries. existing covid- surveys from china, the united kingdom and germany were reviewed to inform development of the present survey. in addition to demographic information, the survey included questions examining chronic health conditions; depression, anxiety and stress; and physical and health behaviors such as physical activity, sleep, smoking and alcohol consumption. the current paper only reports on measures included in the survey associated with the study aim. demographic characteristics included age, gender, marital status, educational attainment, income and chronic disease status. psychological distress was assessed using the well-established -item depression, anxiety and stress scale (dass ) [ ] . seven items for each component were scored on a -point likert scale ranging from (did not apply to me at all) to (applied to me very much, or most of the time). scores for depression, anxiety and stress items were summed with valid scores ranging from - for each component. symptom severity was scored according standard cut-points [ ] . physical activity was assessed using the active australia survey (aas) which comprises eight items assessing frequency and duration of walking, moderate and vigorous leisure physical activities, and vigorous gardening over the past seven days. total physical activity was calculated according to the aas guidelines, where total minutes of physical activity = minutes of walking + minutes of moderate activity + (minutes of vigorous activity × ) [ ] . a single item asked participants to report their change in physical activity since the onset of covid- , with six response options ranging from (i am much more physically active than usual) to (i have ceased physical activity altogether). sleep was assessed using two items. first, participants were asked how many hours, on average, they slept per night prior to the onset of the covid- pandemic (sleep quantity). second, participants indicated the effect of the covid- pandemic on current sleep quality using the question, "since the onset of the covid- pandemic, i...". five response options ranged from "am sleeping much better than usual" to "am sleeping much worse than usual". smoking behavior was assessed by asking whether respondents consumed cigarettes or other tobacco products prior to the onset of covid- . change in smoking behavior was examined using a single item with ten response options ranging from "since the onset of the covid- pandemic, i... smoke much more than usual", to "have not smoked (i am a non-smoker)". current alcohol use was examined using the first item of the alcohol use disorder identification test consumption (audit-c) [ ] , which asks how often alcohol is consumed. response options were "never", "monthly or less", " - times a month", " - times a week", and " or more times a week". changes in alcohol consumption was assessed using a single self-report question: "since the onset of the covid- pandemic i . . . ", with the following response options: "drink much more than usual", "drink a little more than usual", "drink about the same as usual", "drink less than usual", "drink much less than usual", "intend to reduce my drinking", "intend to cease drinking", or "have ceased drinking altogether". sas v . (sas institute inc., lane cove, australia) was used for the analysis. the descriptive statistics, including frequencies and percentages, were generated for categorical variables; means and standard deviations (sd) were generated for continuous variables. depression, anxiety and stress scores were compared based on participant's sociodemographic and health status using non-parametric analysis of wilcoxon rank-sum, the kruskal-wallis test and spearman's correlation. the responses for each behavior, i.e., physical activity, sleep, smoking and alcohol use, were recoded into negative change (− ), no change ( ), or positive change (+ ) for separate analyses of changes in each behavior. a multiple lifestyle behavior index [ ] was created by summing the scores of the four behavior change items to reflect a composite health behavior change score, ranged from - to + . the average composite health behavior change scores and sd were presented separately for each level of depression, anxiety and stress. linear regression was used to test associations between composite health behavior change score and depression, anxiety and stress. crude estimates and estimates adjusted for age, years of education, gender, marital status, household income and chronic disease status were reported with % confidence intervals (ci). logistic regression was used to test whether negative changes in individual behavior change items were associated with depression, anxiety and stress. crude odds ratios (or) (model ) and ors adjusted for age, years of education, gender, marital status, household income and chronic disease status (model ) with % ci were reported. all p-values were two-sided and considered significant if less than . . the sociodemographic and health characteristics of the study sample are presented in table . in total, people (mean age . ± . years, female) completed the survey. most (n = , . %) were married or in a relationship, and almost half (n = , . %) reported having at least one chronic health condition. the average score for depression was . ± . ; anxiety, . ± . ; and stress, . ± . . the average physical activity of participants was . minutes/week, but almost half (n = , . %) reported a reduction in physical activity since the onset of the covid- pandemic. the average sleep duration reported prior to the onset of covid- was . ± . h per night, with half (n = , . %) reporting no change in sleep quality since covid- . most (n = , . %) were non-smokers, and the majority (n = , . %) reported no change in smoking since the onset of covid- . almost one-quarter (n = , . %) reported consuming alcohol on four or more occasions per week, and just over half (n = , . %) reported no change in alcohol consumption. the depression, anxiety and stress scores in relation to different sociodemographic and health characteristics are presented in table . no significant differences were found between males and females for depression and anxiety; however, females had significantly higher stress scores compared to males. younger individuals ( - years) had significantly higher depression, anxiety and stress scores compared to their older counterparts. similarly, those who were not in a relationship had significantly higher depression, anxiety and stress scores compared to other categories of relationship status. the spearman's correlation showed a significant negative association between years of education (recorded as a continuous variable) and scores for depression, but not for the anxiety or stress scores. those in the lowest income category had significantly higher depression scores compared to higher income categories; however, no difference was observed between different weekly household incomes and anxiety and stress. respondents who had been diagnosed with a chronic illness reported significantly higher depression, anxiety and stress scores, compared to those without chronic illness. diagnosed with a chronic disease the mean changes in composite health behavior score, stratified by depression, anxiety and stress severity, are presented in table . for depression, anxiety and stress, the number of people in each symptom severity category decreased as the symptom severity increased, except for the categories of extremely severe depression and anxiety. for depression, anxiety and stress, the mean composite health behavior change score decreased as the symptom severity increased, except for the categories of extremely severe anxiety and stress. associations between depression, anxiety and stress severity and negative change in behavior are outlined in table . since adjustment for age, years of education, gender, marital status, household income and chronic disease status did not impact associations, only adjusted or's are presented. participants who reported a negative change in physical activity were more likely to have higher depression (adjusted or = . , % ci = . , . ), anxiety (adjusted or = . , % ci = . , . ), and stress (adjusted or = . , % ci= . , . ) symptoms. those who reported a negative change in sleep were more likely to have higher depression (adjusted or = . , % ci = . , . ), anxiety (adjusted or = . , % ci = . , . ), and stress (adjusted or = . , % ci = . , . ) symptoms. for those who reported a negative change in smoking, they were more likely to have higher depression (adjusted or = . , % ci = . , . ), anxiety (adjusted or = . , % ci = . , . ), and stress (adjusted or = . , % ci = . , . ) symptoms. similarly, those who reported a negative change in alcohol intake were more likely to have higher depression (adjusted or = . , % ci = . , . ), anxiety (adjusted or = . , % ci = . , . ), and stress (adjusted or = . , % ci = . , . ) symptoms. the results were consistent for composite change scores. there was a decrease of . ( % ci = − . , − . ), . ( % ci = − . , − . ), and . ( % ci = − . , − . ) points in composite change score for every point increase in depression, anxiety and stress. the present study examined the association between depression, anxiety and stress and the change in health behaviors of physical activity, sleep, smoking and alcohol use subsequent to the onset of covid- , as individual health behaviors and as a health behavior change index composite score. the main findings were that all aspects of psychological distress (depression, anxiety and stress) were significantly associated with changes in health behavior, both independently and as a composite score. numerous studies have examined the association between a range of health behaviors and psychological distress factors. for example, rebar and colleagues reported significant inverse associations between physical activity participation and depression and anxiety levels in their meta-analysis [ ] . previous work has reported significant positive associations between smoking, and depression [ ] , but not between smoking cessation and reductions in depression or anxiety [ ] . large-scale studies also demonstrate a significant association between alcohol misuse and psychological distress [ ] . taken together, the findings of previous work suggest variability in the associations between lifestyle behaviors and depression, anxiety and stress that appear to depend on the nature of the behavior under investigation. the present study also demonstrated that, as the severity of depression increased, the composite health behavior change score worsened. that is, those with normal levels of depression symptoms reported a small negative change (− . points), while for those with extremely severe symptoms, the change in composite health behavior change score was more than three times greater (− . ). for anxiety and stress, as symptom severity increased from normal to severe, so did negative changes in composite health behavior change score. linear regression showed a significant association between increased depression, anxiety and stress, and negative changes in composite health behavior change scores. logistic regression showed that, compared to no change or positive change, a negative change in all behaviors was associated with a significantly greater likelihood of increased depression, anxiety and stress. a number of reports suggest covid- is likely to have significant impacts on psychological distress [ , ] ; however, the data from the present study suggest that the mean scores for depression, anxiety and stress are mostly within the normal to mild range. moreover, the mean scores for depression and stress were only slightly elevated when compared to normative data for australian adults, and anxiety the scores were marginally lower [ ] . viewed another way, more than % of all respondents reported psychological distress within the normal range, and less than % reported severe to extremely severe scores. the mean scores for depression, anxiety and stress in the present study are all substantially lower than those reported in italy. mazza and colleagues [ ] reported mean depression, anxiety and stress scores of . , . , and . , respectively, compared to . , . , and . , respectively, in the present study. these differences may be accounted for in the timing of data collection as data from italy were collected in mid-march, differences in government responses to the pandemic, and differences in the severity of impact on the population. the prevalence of moderate to severe depression in the present study ( . %) is comparable to that reported in china ( . %) [ ] ; however, the prevalence of moderate to severe anxiety is markedly less in this study ( . %) compared to that in china ( . %). in contrast, the prevalence of moderate to severe stress reported in this study ( . %) is almost double that reported in china ( . %). the timing of data collection may account for some of these differences since the data from china were collected from residents in cities during late january-early february, one day after the world health organization declared a public health emergency. in contrast, the data for the present study were collected in early to mid-april when significant travel and social distancing restrictions were already in place. it is possible that the low prevalence of depression may also be a result of government investment in mental health support services. the lower anxiety scores in the present study may be attributed to respondents being somewhat accustomed to changes in social contact, whereas the higher stress levels may be attributed to the uncertainly about the future, particularly regarding job losses and economic stress. the total average physical activity was . ± . min/week. this is similar to recent australian bureau of statistics data based on the active australia survey, showing that australians aged and over reported min of daily activity, or min per week on average [ ] , but substantially less than the peak of min of activity per week reported by alley and colleagues using the same measure [ ] . physical activity guidelines for australian adults suggest they should accumulate - min of moderate intensity physical activity, - min of vigorous intensity physical activity, or an equivalent combination of both, per week. however, here we report total physical activity, not moderate or moderate-to-vigorous activity. the aas is known to overreport physical activity participation, but actigraphy is not practical in large samples [ ] . therefore, our data may be an over-representation of actual physical activity performed. almost half of our respondents ( . %) reported a negative change (reduction) in physical activity since the onset of the covid- pandemic, but about % also reported a positive change. this is important to note, since there has been considerable emphasis in the media on the importance of maintaining physical activity for physical and mental health benefits [ , ] . our data suggests these recommendations may have been ineffective for most people, but not all. these data are hard to interpret as there has been a visible increase in people using walking paths all over the country, as well as a strong increase in registrations to the , steps australia program [ ] . it may be that the extra people who are walking are predominantly those who were already active (e.g., gym and sports club members) prior to the covid- onset, but had to undertake different activities at different locations due to the closure of exercise and sporting facilities. the reported overall decline in physical activity is likely a consequence of social distancing, travel restrictions, the closure of usual exercise venues, or unwillingness to change previous exercise habits. nonetheless, given the psychological distress responses to covid- , [ ] and the established benefits of physical activity on psychological distress [ , ] , additional strategies to promote physical activity are needed. prior to the covid- pandemic, mean sleep duration was . ± . h, which meets the guidelines of - h for adults [ ] and aligns with a recent national study of australian adults [ ] . although half ( . %) of all respondents reported no change in sleep quality since the onset of the covid- pandemic, . % reported a negative change. this is unsurprising given the potential for psychological distress during a global pandemic, change in exercise behaviors, and employment and relationship concerns. a number of recommendations have been made to address poor sleep during covid- , including maintaining a regular sleep routine, taking time for self-reflection, limiting exposure to covid- -related news, and getting regular exercise during daylight hours [ ] . apart from these covid- -specific recommendations, most principles mirror those recommended for good sleep hygiene in usual circumstances. only % of survey respondents were smokers. this is less than the % prevalence of smoking recently reported among australian adults [ ] . overwhelmingly, respondents have not changed their smoking behavior, with almost % reporting no change or a positive change (reduction) in smoking status since the onset of the covid- pandemic. among smokers, . % (n = ) report a positive change (reduction), . % (n = ) report no change, while . % (n = ) report a negative change (increase) in smoking behavior. since covid- is a respiratory illness, and smokers are more susceptible to respiratory tract infections, there is significant potential for adverse events in this population. early evidence from china suggests either a significant association, [ ] or at least a trend [ ] toward smoking being associated with poor prognosis in covid- cases. to date, there has been limited attention in the media to smoking cessation programs or adverse risk associated with smoking. although more research is needed, health promotion efforts directed at educating the population regarding the risks for smokers during the covid- pandemic are needed. these may include higher exposure to passive smoking during periods of lockdown or relapse-preventions strategies targeting those who have recently ceased smoking. almost three quarters of respondents reported no change or a positive change (reduction) in alcohol use since the onset of covid- . a reduction in alcohol use might be driven by closures to licensed establishments such as bars and clubs and temporary restrictions on alcohol purchases. in contrast, around one quarter of respondents reported a negative change (increase) in alcohol consumption. this is consistent with research by australia's foundation for alcohol research and education [ ] reporting that % of australians increased alcohol purchases since the onset of covid- and % were drinking more than usual. worryingly, this report suggests that almost % of adults are drinking more to cope with psychological distress [ ] . concerns such as these have prompted the australian government to invest more than aud million into drug-and alcohol-related services to combat the risk of substance abuse and related harms, such as domestic violence, due to the pandemic. to the best of our knowledge, this is the first published study to report associations between health behaviors and psychological distress in australian adults during the covid- pandemic. one published study from europe reported that reductions in physical activity and increased sedentary behaviors during lockdown were associated with negative changes in physical and mental health [ ] . moreover, a number of reports have highlighted the need for rapid and comprehensive responses to increasing mental health needs during covid- [ , ] ; however, it is expected this support will need to be maintained for some years to come given the magnitude of the covid- pandemic. there are a number of strengths of the present study, including the inclusion of multiple health behaviors, a large sample size, and the timing of data collection relative to lockdown restrictions in australia. however, there are also some limitations to consider. firstly, all data are self-reported meaning responses are subject to recall bias. secondly, data are cross-sectional and therefore causality cannot be inferred. thirdly, participants in the present study are older compared to other studies examining health behaviors such as sleep [ ] , and thus the generalizability to other populations needs to be confirmed. additionally, longitudinal data are needed to observe changes over time to assess the impact of changes in social restrictions. finally, our sample was recruited conveniently and therefore the results may not be generalizable to populations with different characteristics. in conclusion, our data suggests negative changes in health behaviors are associated with increased psychological distress in australian adults during the covid- pandemic. effective health promotion strategies directed at adopting or maintain positive health-related behaviors such as targeted social media messaging and balanced media reporting, should be used to reduce the acute and chronic increases in psychological distress during these unprecedented times. ongoing evaluation of the impact of lockdown rules and social distancing (associated with the pandemic) on health behaviors is necessary to inform these targeted health promotion strategies. the psychological impact of quarantine and how to reduce it: rapid review of the evidence psychological interventions for people affected by the covid- epidemic the emotional impact of coronavirus -ncov (new voronavirus disease) the mental health consequences of covid- and physical distancing: the need for prevention and early intervention role of physical activity and sedentary behavior in the mental health of preschoolers, children and adolescents: a systematic review and meta-analysis the evidence for physical activity in the management of major mental illnesses: a concise overview to 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sales and use during covid- ; foundation for the enemy who sealed the world: effects quarantine due to the covid- on sleep quality, anxiety, and psychological distress in the italian population this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the research received no external funding. the authors declare no conflict of interest. key: cord- -m v q gk authors: bidaisee, satesh; macpherson, calum n. l. title: zoonoses and one health: a review of the literature date: - - journal: j parasitol res doi: . / / sha: doc_id: cord_uid: m v q gk background. one health is a concept that was officially adopted by international organizations and scholarly bodies in . it is the notion of combining human, animal, and environmental components to address global health challenges that have an ecological interconnectedness. methods. a cross-sectional study of the available literature cited was conducted from january when the one health concept was adopted till december to examine the role of the one health approach towards zoonoses. inclusion criteria included publications, professional presentations, funding allocations, official documentation books, and book chapters, and exclusion criteria included those citations written outside the period of review. results. a total of resources met the inclusion criteria and were considered in this review. resources showed a continuous upward trend for the years from to . the predominant resources were journal publications with environmental health as the significant scope focus for one health. there was also an emphasis on the distribution of the work from developed countries. all categories of years, resources, scopes, and country locale differed from the means (p = . ). year of initiative, scope, and country locale showed a dependent relationship (p = . , p = . , and p = . , resp.). conclusion. our findings demonstrate the rapid growth in embracing the concept of one health, particularly in developed countries over the past six years. the advantages and benefits of this approach in tackling zoonoses are manifold, yet they are still not seemingly being embraced in developing countries where zoonoses have the greatest impact. one health is a concept that aims to bring together human, animal, and environmental health. researchers including louis pasteur and robert koch and physicians such as william osler and rudolph virchow demonstrated the collaborative links between animal and human health. more recently, calvin schwabe revived the concept of one medicine [ ] . as the traditional boundaries between medical and veterinary practice continue to pervade society there is a need for the practical application of one health. one health is defined by the one health commission [ ] as "the collaborative effort of multiple disciplines to obtain optimal health for people, animals, and our environment. " in another definition, the one health initiative task force (ohitf) [ ] defines one health as "the promotion, improvement, and defense for the health and well-being of all species by enhancing cooperation and collaboration between physicians, veterinarians, and other scientific health professionals and by promoting strengths in leadership and management to achieve these goals. " the one health approach plays a significant role in the prevention and control of zoonoses. it has been noted by the world health organization (who) [ ] and graham et al. [ ] that approximately % of new emerging human infectious diseases are defined as zoonotic, meaning that they may be naturally transmitted from vertebrate animals to humans. new and reemerging zoonoses have evolved throughout the last three decades partly as a consequence of the increasing interdependence of humans on animals and their products and our close association with companion animals. zoonoses should therefore be considered the single most critical risk factor to human health and well-being, with regard to infectious diseases. of the , infectious diseases journal of parasitology research recognized to occur in humans by the national academy of sciences, institute of medicine [ ] , approximately % are caused by multihost pathogens, characterized by their movement across various species. this gives significant credence to the importance of examining health effects across species, in order to fully understand the public health and economic impact of such diseases and to help implement treatment and preventive programs. the one health concept is a broad term that covers a variety of subcategories identified as bioterrorism, animals as predictors for disease, and the psychological bonds that can exist between an animal and a human [ ] . zoonoses comprised the primary focus for this review with the overall objective to determine the status of the one health approach and its applications to zoonoses, using scholarly peer-reviewed literature that has been published since the global adoption of the concept in (for study purposes, january , , until december , . four subobjectives were considered. the first assessed scholarly resources on the one health approach published works between january , , and december , . one health scholarly resources were classified as peer-reviewed publications, professional presentations, grants or funding allocations, reports from the who, and books or book chapters. the second objective examined the preferred scope of one health published works within the period of study. scopes of one health subject categorizations were, namely, zoonoses, food safety, agriculture, environmental health and global health. the third objective analyzed the geographic distribution of scholarly one health resources, whether they were in developed nations or developing nations listed by the international monetary fund (imf). the final objective reviewed trends in the application of the one health concept. a cross-sectional study using internet resources was carried out to analyze one health applications to zoonoses in scholarly resources from to , representing a -year review. before conducting the internet search, clear definitions were made of the one health resources. scholarly material was distinguished as eligible and ineligible using the following criteria which were found on google scholar and ebscohost. ( ) peer-reviewed publications were classified as scientific journals and literature reviews of the pertinent subject matter (human, animal, and environmental health) that had been published in peer-reviewed journals. ( ) professional presentations were represented by formal presentations made by organizations and other professionals on the subject matter of human, animal, and environmental health, presenting research material, policy developments, or promotional activities in support of one health. ( ) grants and funding allocations were characterized as proposals for funding research, policy development, and so forth in the collaborative subject matter of humans, animals, and the environment accessed from reviewing all professional publications available from the systematic search conducted. ( ) who-related reporting included updates from the website that involved relevant health issues, specifically reflecting the one health approach. ( ) book and book chapters were qualified as books or selections involving the subject matter. the target population included all published studies that addressed the one health philosophy and which met the inclusion criteria. the documentation review included resources found on the internet through the search engines and databases identified, which fit into the criteria of a one health approach and which took place from the concept's adoption of january , . excluded from this study were studies that were not found on the internet databases, those that did not involve the one health concept, or fit the criteria of a one health approach, or those that were reported outside the period of study. database searches were conducted from may to july . in the search fields for google scholar and ebscohost, the terms "one health, " "health, " "human, " "animal, " and "zoonoses" were typed in. the first result that appeared from the database was reviewed and then assessed, using the definitions, to determine whether it fits into one of the one health approach criteria. every fifth search result was examined and after reaching results on both databases numbered onward, every second result was then considered. for every result that did not meet the inclusion criteria, the very next result was examined, and so forth, until a result did meet the criteria. after a result met the criteria, the fifth result from the last selected result was examined to be included in the review. each scholarly initiative that met the inclusion criteria was separated into its initiative category as well as into its year of publication. in addition, each resulting initiative was further categorized by the subject matter covered in the scholarly work. considering one health scopes, these were the common subject areas covered: zoonoses, agriculture, food safety, environmental health, and global health. these categories were condensed from a larger, more complex list provided by the one health initiative task force [ ] . for resources that contributed to more than one scope, such as agriculture and food safety, the final determination was made on the emphasis of one of the scopes from within the contents of the title. finally, each initiative was also categorized into being conducted in, or having an analysis on, either a developed or developing nation based on a country's gross domestic product (gdp). all the results were then categorized by their year of publication, the initiative that was represented, scope covered within the work, and the geographic distribution of where the initiative was conducted or what area was analyzed. spss statistical software package version . was used to analyze the frequencies of the years of scholarly resources, the initiative types, scopes categories, and geographic distribution. all years for the review were represented, except for , , and as there were no publications that were sourced for these three years. there were a total of resources in ( %) and in ( . %). the year began a continuous presence of one health resources annually. the year began a continued increase in one health resources for the period of review. the years to were the most productive for publications on one health as % of publications occurred during this period of time. an overall increase in the number of published one health scholarly works was found for the review with a marked increase in the most recent years ( figure ). journal articles, presentations, who reports, and books or book chapters were included in the analysis. grants and funding allocations were not represented in the data gathering process. of the resulting resources, peer-reviewed journal articles took precedence ( %) of all publications, while presentations and books accounted for . % and . %, respectively; only one who report was recorded. evaluation of scopes, covered in the scholarly resources (figure ), revealed that the predominant topics were global health, with scopes ( . %), and environmental health, with total scopes ( . %). in terms of geographic distribution of the scholarly resources, most of the resources focused their objectives within or towards countries that were already developed ( %) (figure ). an assessment on how one health initiatives were distributed by country size and gdp was achieved by mapping and measuring the burden of zoonoses and its distribution across the world ( table ) . events of zoonoses were found to be disproportionately distributed as a result of the poverty and emerging market interface. outbreaks or epidemics of emerging zoonoses were also noted to be sporadic in temporal and spatial distribution and appeared in developed countries where emerging zoonoses had not previously been reported but are increasing in incidence or geographical range. data on zoonoses extracted from the global burden of diseases noted that endemic zoonoses were concentrated among the developing countries of india, nigeria, democratic republic of congo, china, ethiopia, and bangladesh, whereas emerging zoonoses events were reported in the developed countries of the united states, united kingdom, australia, france, brazil, canada, germany, and japan (table ) [ ] . for data analysis, chi-square was conducted to determine if, in the resulting reviewed years, one health resources themselves, scopes, and country locale differed significantly from the averages expected. analysis revealed values of less than . ( < . ), meaning that the resources, scopes, and country locale were all statistically different ( table ) . further analysis employed linear regression, using each focus, year, one health resource, scope, and country as the dependent variables and comparing them against independent variables of themselves. this showed whether the relationship between the independent and dependent variables was predictive or dependent on one another [ ] . in the case of using year as the dependent variable, the regression shows that it was dependent on the initiative ( = . ), scope ( = . ) and the country locale ( = . ) ( table ) . since all the values were < . , the null hypothesis was rejected and it was concluded that the years selected for the study showed a dependent relationship on the one health approach conducted, the scope topic areas and the represented country in the scholarly work. the same linear regression was performed, this time using the initiative as a dependent variable against the other variables (table ) . for this analysis, the initiative showed it to be dependent on the year ( = . ), as also noted in table , but not dependant on scope ( = . ) nor on the country's locale ( = . ). the null hypothesis failed to be rejected because no complete dependency relationships were formed between all the variables from the regression test that was conducted, as compared to the regression testing done with year. next, scope was selected as the dependent variable against the year, initiative, and country. the linear regression showed that the scope was dependent on the year, as seen before ( = . ), but not dependent on the initiative ( = . ) nor on the country ( = . ) ( table ). the null hypothesis thus failed to be rejected. the country locale was used as the dependent variable against the others in the last linear regression. it was demonstrated that the country, whether developed or developing, was dependent on the year ( = . ) but not on the initiative ( = . ) nor the scope ( = . ) ( table ) . again, the null hypothesis failed to be rejected for the whole dependency of scope on all other variables. the only rejected null was the dependency displayed between the year of the initiative and the initiative itself, its scope, and the country covered from within the initiative. many of the results of this study could be attributed to the occurrences in the world during the time period of the study. when observing the trend of the one health approach over time, there was a minimal spike in , an increased output from , and marked increase from to . four [ , ] and also to the passing of the one health initiative task force in [ ] . two ( . %) of the defined resources in involved agriculture, eight involved environmental health ( . %), were on zoonoses ( . %), were on global health ( . %), and four were on food safety ( . %). the marked increase since may have resulted from the developments since which continued into which allowed for the one health approach to be placed on the research and scholarly agenda. ( %) of the recorded resources in involved agriculture, ( %) involved environmental health, ( . %) were on zoonoses, ( . %) were on global health, and ( %) were on food safety. the distribution of the years of the one health approach, the scholarly resources, the scopes, and the countries' locale were not equally represented. for the one health concept to be appropriately beneficial to the global population, it would be necessary for a significant equal distribution of scholarly works to exist. the data, suggesting that the scopes of global health ( . %) and environmental health ( . %) dominated the others, including the zoonoses, produces an area of concern. the issues relating to one health, while in their genesis involved zoonoses and food safety, were identified as environmental and global health issues in the reporting and publications. while this shows evidence of the profound efforts to boost environmental and global knowledge about one health, it also demonstrated the limited body of knowledge of zoonoses, agriculture, and food safety. zoonoses, agriculture, and food safety are all interconnected topics in that they all directly impact the health of humans. in the last years, there has been an average of one newly discovered emerging infectious disease every year [ ] . a total of emerging infectious diseases were identified between and [ ] . considering that more than % of infectious diseases are zoonotic, they have an important and increasing impact on human health. agriculture, livestock production, and food safety practices are intimately linked with the prevention and control of zoonoses through the one health approach [ ] . considering the significance of agriculture and food safety, it was surprising that these scopes did not have a greater representation in the literature reviewed. developed countries, by virtue of their greater institutional facilities, trained personnel and financial resources are able to address the issues of one health approach. this is extremely beneficial as it enables developed nations to gain an awareness of one health initiatives and the added synergistic value of this approach. the one health initiative task force [ ] has reported that while the developed countries prevail in making one health discoveries, it is the developing countries that suffer the most from the effects of zoonoses. it has been estimated that % of the reasons for poverty in africa can be attributed to poor livestock production practices [ ] . zoonotic infections significantly impact animal production in this region further jeopardizing human and animal livelihoods. the dependency of the initiative year, initiative, scope, and country locale on one another revealed that the incidence of the scope or country location is somewhat dependent on the year. in other words, it can be argued that the scope or country locale was represented due to that particular year, namely, due to the associated events during that year. immediate action and scholarly resources are commonly implemented after a devastating event occurs [ ] , proving that the publishing of a particular one health topic may not be due to chance during that specific year. it is important to note that the general availability of one health resources is likely to be higher in the more recent years than in the s, as the internet was still in its evolutionary stage and not yet a global resource, as it is today [ ] . the free availability of scholarly information on the internet is evolving rapidly which will equalize the field. it will then be a matter of trained personnel and resources to make appropriate advances. many of the classifications which determined the scope of an initiative were subjective. even though many of them clearly fit into their appropriate scope, some were hard to decipher, as some titles could have easily been included in more than one scope. as a result, one author's classification of an initiative could differ from another's opinion, resulting in interobserver bias. some resources truly belonged in their own category; however, for the purposes of this study, only five scopes were included. this resulted in many resources being placed in the global health scope, as it is a category that could be applied to all one health approaches. subjectivity was also a limitation in classifying the country locale. in some cases, resources' locations were clear from the article's title or content, and others were not. some scholarly resources covered subject matter concerning a developing country, yet the actual work was conducted in a developed country. the one health approach, according to the one health initiative, has been utilized to accelerate biomedical research discoveries, enhance public health efficacy, expeditiously expand the scientific knowledge base, and improve medical education and clinical care [ ] . the increasing encroachment of people and livestock into wildlife habitats provided a multifaceted need to study bats and offer understanding for study at the human-wildlife interface [ ] . bats are an important reservoir and vector for spread of a number of emerging infectious diseases and they are associated with zoonoses with global public health significance such as lyssa, hendra and nipah viruses, severe acute respiratory syndrome (sars) like coronaviruses, and ebola and marburg viruses. the importance of wildlife as reservoirs of human diseases has also been widely recognized for most of the parasitic zoonoses, including american and african trypanosomiasis, leishmaniasis, giardiasis, cryptosporidiosis, balantidiasis, fascioliasis, opisthorchiasis, clonorchiasis, paragonimiasis, schistosomiasis, echinococcosis, taeniasis, diphyllobothriasis, sparganosis, dipylidiasis, trichinellosis, toxocariasis, strongyloidiasis, and ancylostoma caninum and a. braziliense infections. molecular phylogenetic methods used to examine the genetic diversity and species composition of these parasites in humans and their domestic and wild reservoir, paratenic, definitive, and intermediate host species have shown that they are in many instances identical. for example, african trypanosomes identified in wildlife in the serengeti in tanzania and the luangwa valley in zambia which harbour a wide range of trypanosomes are the same species which infect humans and livestock [ ] . the one health concept has successfully replaced the disease centered approach to zoonoses with a system based approach that aligns multiple disciplines, working locally, nationally, and globally, to attain optimal health for people, domestic, and wild animals and the environment. zoonotic diseases pose both major health threats and complex scientific and policy challenges, to which the social, cultural, and political norms and values are essential to address successful control outcomes [ ] . the need to employ one health is illustrated in the cases of h n avian influenza in which control failed due to the lack of addressing the complex dynamics of zoonotic diseases. rapid response briefing [ ] produced a report on the ebola haemorrhagic fever outbreak which occurred in kibaale and kampala in uganda in . the number of deaths in kibaale was at least ; the outbreak was spread miles away to kampala four months later. these two outbreaks demonstrated the continuing existence of ebola in uganda which recorded an earlier outbreak in and led to cases; more than half of the cases died. the one health approach, employing disease surveillance, management, and eradication through collaboration between veterinarians dealing with livestock and wild animal populations and ecologists examining ecosystem biodiversity and public health experts, may have yielded a more rapid resolution to the outbreak the application of the one health approach has been recognized as a critical need by international organizations as well as the preferred approach to address global health issues. the grand challenges in global health [ ] is based on the theme "the "one health" concept: bringing together human and animal health for new solutions. " the recent call for proposals for funding recognizes the lack of knowledge sharing and an artificial barrier that separates the fields of human and animal health. the grand challenges in global health specifically identified that advances in drug and vaccine discoveries for human diseases can be applied to provide tools and approaches for animal diseases that still plague developing countries. it is also noted that knowledge in veterinary medicine and animal nutrition and husbandry could provide insights into human nutrition and growth. one health has gained momentum and now encompasses zoonotic infections, food safety, and even health delivery systems [ ] . there is also an integrated epidemiological and economic framework for assessing zoonoses using a "one health" concept building on the medical focus of zoonoses [ ] . in recent times the one health concept has been expanded to encompass the health and sustainability of the world's ecosystems [ ] . based on complex ecological thinking that goes beyond humans and animals, these approaches consider inextricable linkages beyond the human, animal, and environmental interface. collaboration between veterinary, medical, and public health professionals to understand the ecological interactions and reactions to flux in a system can facilitate a clearer understanding of climate change impacts on environmental, animal, and human health. climate change adds complexity and uncertainty to human health issues, such as emerging infectious diseases, food security, and national sustainability planning [ ] . these issues intensify the importance of interdisciplinary and collaborative research. evidence for expanded application of one health compared to separate sectoral thinking is growing [ ] and this integrative thinking is increasingly being considered in academic curricula in schools of medicine, veterinary medicine and public health [ ] , clinical practice, ministries of health and livestock/agriculture, and international organizations [ ] . the one health approach to zoonoses however remains an average priority for health care professionals. the impact of zoonoses on animal health has been largely neglected but the effects on public health usually drive control initiatives on zoonoses and are much better defined by the use of disability adjusted life years (dalys) [ ] . the first zoonoses prioritization exercise involving health professionals in north america who had a limited knowledge of infectious diseases identified zoonoses as an area of priority [ ] . another study reported that local public health agencies in north america were not prepared and potentially unaware of their responsibility to be the initiator of the work on zoonotic disease information intelligence [ ] . the advancement of the one health approach has increased the discussion and reporting on the topic. there remains a lack of knowledge and application of the integrated approach to health care by the health care professionals. reaching the goal of control, and elimination and/or ultimate eradication of zoonoses pose a significant challenge for the future. standardized interlaboratory test validation, intersectoral collaboration and establishment of an international one health diagnostic platform are considered to be important strategies [ ] . the sharing of best practices on diagnosis of zoonoses and the further refinement of new, cheaper, multispecies tests which can be interpreted by minimally trained individuals could contribute to a greater level of intersectoral integration, control, and elimination of zoonoses. the projection from one health may eventually lead to a one system approach based on the inherent challenges to intersect disciplines that belong to different systems. one health approaches applied across international boundaries that share the same challenges are required to create sustainable and coordinated control. the one system approach focusing on the strengthening of the community model health system as a whole as well as developing effective and novel tools to be applied across all aspects of health, is fundamental of a one world one health approach [ ] . the future of one health is a one world approach with the continued effort towards integration of the contributing parts that form the whole which is health. the one health approach continues to be a highly investigated concept, via the pursuit of scholarly resources involving the health of humans, animals, and the environment. there is a need to increase research on zoonoses, food safety, and agriculture and to improve the understanding of the one health concept. this could be achieved by introducing more scholarly resources in developing countries by the further development of the internet and the free availability of online information on one health. the use of massive open online courses (mooc) available to developing countries is now being offered to deliver courses on the approach and applications of one health [ ] . this is critical because most of the public health and economic impacts that occur within the concept of one health occur in developing nations. the lack of basic health infrastructure in developing countries means that everything else suffers as a result, namely, the environment, human, and animal health and well-being. the future of one health is at a crossroad; there is a need to more clearly define its boundaries and demonstrate its benefits. the greatest acceptance of one health is seen where it is having significant impacts on control of infectious diseases. there is also a continuing need for further efforts towards integration with the global community serving as the unit of a one system approach. one health: its origins and future. current topics in microbiology and immunology one health. 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environmental healthchampions of one health towards improved diagnosis of neglected zoonotic trematodes using a one health approach elimination of tropical disease through surveillance and response massive open online course (mooc) course on the canvas network the authors declare that there is no conflict of interests regarding the publication of this paper. key: cord- -th jo u authors: akseer, nadia; kandru, goutham; keats, emily c; bhutta, zulfiqar a title: covid- pandemic and mitigation strategies: implications for maternal and child health and nutrition date: - - journal: am j clin nutr doi: . /ajcn/nqaa sha: doc_id: cord_uid: th jo u coronavirus disease (covid- ) continues to ravage health and economic metrics globally, including progress in maternal and child nutrition. although there has been focus on rising rates of childhood wasting in the short term, maternal and child undernutrition rates are also likely to increase as a consequence of covid- and its impacts on poverty, coverage of essential interventions, and access to appropriate nutritious foods. key sectors at particular risk of collapse or reduced efficiency in the wake of covid- include food systems, incomes, and social protection, health care services for women and children, and services and access to clean water and sanitation. this review highlights key areas of concern for maternal and child nutrition during and in the aftermath of covid- while providing strategic guidance for countries in their efforts to reduce maternal and child undernutrition. rooted in learnings from the exemplars in global health's stunting reduction exemplars project, we provide a set of recommendations that span investments in sectors that have sustained direct and indirect impact on nutrition. these include interventions to strengthen the food-supply chain and reducing food insecurity to assist those at immediate risk of food shortages. other strategies could include targeted social safety net programs, payment deferrals, or tax breaks as well as suitable cash-support programs for the most vulnerable. targeting the most marginalized households in rural populations and urban slums could be achieved through deploying community health workers and supporting women and community members. community-led sanitation programs could be key to ensuring healthy household environments and reducing undernutrition. additionally, several covid- response measures such as contact tracing and self-isolation could also be exploited for nutrition protection. global health and improvements in undernutrition will require governments, donors, and development partners to restrategize and reprioritize investments for the covid- era, and will necessitate data-driven decision making, political will and commitment, and international unity. as a highly communicable disease, coronavirus disease continues to ravage the state of the world's health and economy ( ) . its impact also underscores the limited progress we have made against noncommunicable diseases (ncds). children and adults with underlying comorbidities, particularly ncds such as diabetes, hypertension, undernutrition, and overweight/obesity, are strikingly vulnerable to serious illness and death from covid- ( ) . yet, covid- response measures such as self-isolation, social distancing, and lockdowns of communities can lead to poor management of key risk factors such as unhealthy diets and physical activity ( ) , and limited access to preventive care in primary care settings. additionally, insecure economic conditions, restricted travel and access to health care services, delayed vaccination schedules, and shuttering of educational facilities further compound poor health conditions for young children, especially in low-and middleincome countries (lmics) ( ) . there is significant concern that covid- responses have had a negative impact on the nutritional status of women and children, and that these could worsen over time. a recent modelling exercise of various estimates of the potential impact of covid- -related economic deterioration, food insecurity, and interruption of programs of community-based detection and management of malnutrition suggests that the prevalence of wasting could increase by - % with an excess of ∼ , - , , child deaths ( ) . we believe that these projected nutrition effects of the global pandemic could well be underestimates, as they fail to take into account the potential effect on maternal nutrition, micronutrient deficiencies, and intrauterine growth as well as downstream impacts on maternal and child health programs that can impact linear growth and childhood stunting. this is unfortunate since the world has made some, albeit slow, progress in reducing childhood stunting over the last decade. current estimates indicate that million children under y are stunted, a reduction from million in but still far from the required global targets for progress ( ) . covid- now threatens to halt or reverse gains even further. if unaddressed, the effects on linear growth in children and consequent stunting could be much more consequential than short-term effects of undernutrition. sectors critical to reducing childhood undernutrition at particular risk of collapse or reduced efficiency due to widespread impact of covid- are summarized below and in figure . • food insecurity and poor-quality diets • building resilient food systems during covid- requires innovative context-specific demand and supply-side initiatives. food supply chains (fscs) are of particular interest, since % of all foods consumed in africa and asia are now dependent on these markets ( ) . despite being nominally "exempt" from lockdowns, covid can have direct and indirect impacts on fsc function in lmics, especially the informal sectors. while direct impacts, through closures of restaurants and restrictions on vendors, represent a small share of the total food economy in urban settings, the impact on rural markets could be much greater additionally, indirect impacts due to unemployment and falling incomes of daily wage laborers and industry workers have taken a heavy toll on people in lmic settings ( ) . further compounding this is the issue of food pricing. restrictions on mechanisms for production and delivery may drive up cost, while fear of shortages could drive speculative hoarding ( ) . loss of household income exposes vulnerable families to price spikes and food shortages, while low agricultural productivity and breaks in the food import-export system disrupt local food markets and small businesses ( ). • additionally, given limited access to fresh produce, children and families may be more likely to resort to cheaper and more accessible processed and prepackaged, highsodium, and less-nutritious foods ( ), with deleterious health consequences. • reduced income and limited financial resources • covid- has pushed millions of households into economic despair and has been described as more lethal than the global financial crisis ( ) . oxfam predicts that half a billion people could be pushed into poverty ( ) , while the world bank contends that an additional - million people could be pushed into extreme poverty ( ) . the interruption of existing social safety nets, especially for women, is a challenge in many lmics struggling with covid- as funds are diverted to immediate needs compounded by limited mobility and access to services. • limited care and restricted health services • given overburdened health systems, restricted travel, and changing priorities at the primary care level, access to routine health services for women and children has suffered tremendously. while quality of care was an ongoing challenge prior to covid- ( ) , in its current state and onward for years targeted efforts for highquality health care for those in the most need will likely take a backseat. consequently, the health and risk of undernutrition in mothers and their children may increase dramatically, especially if current conditions persist long term. in pakistan, available data from district health systems indicate a dramatic drop in access for and provision of antenatal care services (za bhutta, personal communication, ), and others have highlighted the importance of the unmet need for mental health services and interventions ( ) . as has been indicated by united nations population fund (unfpa) ( ) , reduced access to family-planning services and enforced confinement of families is projected to lead to million unintended births in some of the poorest countries of the world. persistent disruptions to routine and requisite maternal care and nutrition could lead to adverse fetal outcomes including preterm birth, low birth weight, and small-for-gestationalage newborns. • interrupted education for children and adults • educational facilities, including primary, secondary, postsecondary, and specialized training institutions, have been shuttered almost completely worldwide in the wake of covid- ( , ) . one of the major effects of covid- has been on exacerbating inequities in education. much has been made of alternative forms of learning, such as online classrooms, web-based courses, and homeschooling, but these are inaccessible to most children in lmics. women and girls, who often experience the highest rates of illiteracy and school drop-outs in lmics, are yet further debilitated and disadvantaged. the benefits of general and specialized health and nutrition education to improve maternal nutrition and reducing intergenerational childhood stunting are indisputable, having been shown consistently in stunting case studies ( ) ( ) ( ) . an additional setback has been the interruption of school nutrition programs, the mainstay of addressing food insecurity in some of the poorest sections of the population. • unhealthy household environment • given diverted funds and priorities, building safe and healthy household and community environments, particularly as related to clean water, appropriate sanitation, and hygiene (wash), may fall behind on country agendas. yet now more than ever, wash interventions are essential to protecting human health and preventing undernutrition ( ) . for instance, in urban slums (some of the most vulnerable communities), lockdowns and limited mobility have impacted access to clean water and safe sanitation services. given the nature of covid- transmission, this could result in lethal outbreaks of infectious diseases. • limited access / proximity to available services (e.g., clean water, safe sanitation) we believe that countries can address these extraordinary nutrition risks across the continuum of mothers, newborns, children, and adolescents by addressing determinants and implementing evidence-informed strategies for action. this narrative is aimed at reviewing key areas of concern for supporting maternal and child nutrition progress during and in the aftermath of covid- , while providing strategic guidance for countries to continue making headway in reducing maternal and child undernutrition while battling covid- . as our research into stunting reduction exemplars has demonstrated, stunting progress in lmics has been driven by a multifactorial set of investments in sectors that have direct and indirect impacts on nutrition (figure ) , most of which are extremely relevant in the current covid- crisis and must be continued. our exemplars underscore multiple examples of high-impact strategies both within and outside a country's traditional health system. these examples were data-driven and enabled by strong, focused country leadership, efficient financing, and effective partnerships ( ) . we believe that the same approach is needed within lmics to address the nutritional consequences of covid- mitigation strategies. the state of the world and our collective response to covid- is continually evolving as new information is received. nevertheless, initial observations across different countries and contexts, along with key lessons from countries managing through other crises in the past, suggest that we prioritize the following approaches to address and prevent exacerbating maternal and child undernutrition: • food insecurity interventions • given the diversity of food environment and security challenges experienced by lmics during covid- , solutions must be context specific. lessons from many stunting-reduction exemplar countries could be useful. in the kyrgyz republic, for instance, the unprecedented economic collapse after the dissolution of the soviet union created new opportunities for mobilizing the agricultural sector to drive economic recovery. a range of radical agrarian reforms focused on revitalizing institutions for land, livestock, capital, and labor, while concurrently, shifting land ownership from the state to private households was considered among the most pivotal driving factors of stunting reduction in kyrgyz republic between and ( ) . while agrarian land reforms focused on shifting land ownership and adopting innovative/efficient agricultural practices may yield dividends on undernutrition in the long term, immediate solutions also have value. one of ethiopia's solutions to food insecurity (i.e., the productive safety net program) was aimed at providing emergency food aid to million individuals vulnerable to food insecurity and was considered important to the country's stuntingreduction narrative ( ) . such long-and short-term solutions addressing both supply and demand-side challenges could be considered for nutrition protection in covid- -affected countries. • social protection programs • the prioritization of efforts to provide economic security by governments to their at-risk populations (e.g., through innovative and targeted social safety net programs, payment deferrals, or tax breaks) is essential to preventing financial collapse of vulnerable households. socialprotection programs are increasingly taking center stage in policy dialogues for tackling poverty, vulnerability, and social exclusion. several exemplar countries, notably peru ( ) and the kyrgyz republic ( ), employed successful financial-incentive based models as a means for providing social safety nets for reaching marginalized and vulnerable populations. in peru, for instance, the juntos conditional cash transfer program provided households with a fixed monthly cash transfer (∼$ usd) to comply with basic education, health, and nutrition services for children. this was paired with strong data-management systems that allowed for identification of vulnerable populations and effective targeting to ensure that resources were disbursed effectively. the kyrgyz republic's monthly benefit for poor families with children program is an analogous essential social-protection scheme that was found to be notably important to stunting reduction in the country. in today's covid- environment, such systems in peru, kyrgyz republic, and many other countries can be leveraged to build on and enhance social and economic protection for vulnerable families, and consequently prevent ill health and chronic undernutrition in children. • access to health care • as has been shown in several stunting-reduction exemplar countries, access to health care for even the most remote and hard-to-reach populations can happen with an effective community health extension system. ethiopia's health extension workers (hews) ( ) and nepal's female community health volunteers (fchvs) ( ) showcase successful models of mobilizing community health workers (chws; who receive basic training and commodities) to deliver vaccines, nutritional supplements, health and nutrition education, and even reproductive, maternal, and newborn care. the current recommendations are to remunerate such chws rather than rely on pure volunteerism. amidst the covid- crises, while the primary health care system may not be fully functional and supplies short, governments could consider calling on existing chw cadres to reprioritize their tasks and cater to emerging maternal, child health, and nutrition screening in communities. these chws are also key to reestablishing programs for community-based management of malnutrition. governments could also invest in deploying additional health workers and incentivizing current workers to continue delivering high-quality essential interventions to families (e.g., vaccines, antenatal care, referrals) and provide essential communication related to covid- preparedness and triage. where community health extension programs currently do not exist, countries may want to consider piloting or adopting such a program to supplement primary health care, as a short-or long-term solution. • educational programs • in the wake of closed formal education systems, countries could mobilize informal institutions such as chws and women's and community support groups to deliver health and general education. these systems are already in place in many lmics and could be revitalized and repurposed for continuing education. several stunting-reduction exemplar countries have shown the potential utility and impact of these mechanisms on stunting reduction. having learned from their experience with ebola, senegal's chw program ( ) has proven to be an effective mechanism for communicating health best practices to the community. nepal's fchv ( ) and ethiopia's hew ( ) programs have also had highly successful health and nutrition counseling components. the kyrgyz republic used women's support groups in communities as a means to keep updated on the evolving health situation and share knowledge ( ), a model that could continue to be expanded upon. • safe and healthy household/community environments • ensuring safe water access and appropriate sanitation and hygiene practices is critical to the covid- containment agenda and health outcomes beyond. while providing infrastructural support to households and communities (e.g., through building wells, community pipes, latrines) is critical, it may fall off short-term agendas as handwashing and hygiene campaigns take precedence. lessons from exemplar countries suggest that high-impact, low-cost community mobilization efforts could play a pivotal role in creating a healthy environment by reducing open defecation and encouraging hygienic practices and have been linked to stunting reduction. the community led total sanitation (clts) programs in nepal ( ), ethiopia ( ) , and senegal ( ) focus on behavioral change to create open-defecation-free villages. the programs trigger the community's desire for collective change through encouraging innovation and context-specific solutions while fostering a sense of community ownership. the clts programs in exemplar countries such as nepal have had a notable impact on childhood stunting reduction. beyond interventions targeting specific challenges for childhood stunting, many ongoing covid- response measures could double as opportunities to address other health and wellbeing priorities such as malnutrition prevention and management in lmics. governments, donors, and development partners during covid- response policy and funding dialogues should strategize on cost and system efficiencies for targeting broader health and nutrition goals within their covid- response plans. the covid- pandemic has thrown the world into an unprecedented crisis, fighting a pathogen that could well be with us for a long time to come. as countries lurch from the shock of large-scale lockdowns to a gradual return to normalcy, the transition will be slow and the new normal very different from the past. safeguarding the health and nutrition of vulnerable women and children is a key policy response and must be based on the best evidence of what works, so that gains in survival and women's and children's health and nutrition are not reversed. governments, donors, and development partners will together need to restrategize and reprioritize investments for the covid- era using data-driven decision making. effective execution of strategies will require money, political will, and commitment, and international unity; these will be pivotal drivers, securing not only covid- -specific gains but also overall protection of global health and improvements in undernutrition. estimates of the severity of coronavirus disease : a model-based analysis comment: prevention and control of noncommunicable diseases in the covid- response don't let children be the hidden victims of covid- pandemic: statement by unicef executive director henrietta fore early estimates of the indirect effects of the covid- pandemic on maternal and child mortality in lowincome and middle-income countries: a modelling study rapid transformation of food systems in developing regions: highlighting the role of agricultural research & innovations covid- lockdowns are imposing substantial economic costs on countries in africa how covid- may disrupt food supply chains in developing countries food security and covid- what does junk food have to do with covid- deaths? environmental health news coronavirus crisis could plunge half a billion people into poverty: oxfam [internet]. world economic forum / /coronavirus-crisis-could-plunge-half-a-billion-people-into-pove rty-oxfam dignity not destitution: an 'economic rescue plan for all' to tackle the coronavirus crisis and rebuild a more equal world the impact of covid- (coronavirus) on global poverty: why sub-saharan africa might be the region hardest hit world bank blogs high quality health systems in the sdg era: countryspecific priorities for improving quality of care impact of the covid- pandemic on family planning and ending gender-based violence, female genital mutilation and child marriage million students out of school due to covid- : unesco releases first global numbers and mobilizes response covid- and children, in the north and in the south drivers of stunting reduction in ethiopia: a country case study drivers of stunting reduction in nepal: a country case study drivers of stunting reduction in peru: a country case study unicef wash programme contribution to covid- prevention and response how can countries reduce child stunting at scale: lessons from exemplar countries drivers of stunting reduction in kyrgyz republic: a country case study drivers of stunting reduction in senegal: a country case study the authors reported no funding received for this study. data described in the manuscript, code book, and analytic code will not be made available because this is a review article and did not have primary data analysis.we thank drs. oliver rothschild and niranjan bose from gates ventures for funding support and overall technical/research support this perspective.the authors' responsibilities were as follows-na, gk, and zab: conceived the perspective outline; na and gk: conducted research and prepared the first draft of the manuscript; zab and eck: provided critical review and feedback; zab: is overall guarantor of the content; and all authors: read and approved the final manuscript. the authors report no conflicts of interest. key: cord- -px e hhi authors: liu, tao; li, jixia; chen, juan; yang, shaolei title: regional differences and influencing factors of allocation efficiency of rural public health resources in china date: - - journal: healthcare (basel) doi: . /healthcare sha: doc_id: cord_uid: px e hhi in the face of increasingly growing health demands and the impact of various public health emergencies, it is of great significance to study the regional differences in the allocation efficiency of the rural public health resources and its improvement mechanism. in this paper, the game competition relationship is included in the evaluation model, and the game cross-efficiency model is used to measure the allocation efficiency of the rural public health resources in provinces of china from to . then, the theil index model and the gini index model are applied in exploring the regional differences in the allocation efficiency of rural public health resources and its sources. finally, the bootstrap truncated regression model is used to analyze the influencing factors of the allocation efficiency of the rural public health resources in china. the results show that, first, the total allocation efficiency level of the rural public health resources in china from to is relatively low, and it presents a u-shaped trend, first falling and then rising. second, the changing trend of the allocation efficiency of the rural public health resources in the eastern, central, and western regions of china is similar to that in the nationwide region, and it shows a gradient trend that “the allocation efficiency in the eastern region is high, the allocation efficiency in the western region is low, and the allocation efficiency in the central region is at the medium level”. however, the gap among the three regions is continually narrowing. third, the calculation results of the theil index and the gini index show that intra-regional differences are the major source of the regional differences in the allocation efficiency of the rural public health resources in china, and the inter-regional differences demonstrate an expansion trend. finally, the improvement of the education level and the social support level will generally improve the allocation efficiency of the rural public health resources in china and its three regions. the increased governmental financial support and urbanization level will reduce the allocation efficiency of the rural public health resources in china and its three regions. the economic development level, the living conditions and the population density are the important influencing factors of the allocation efficiency differences of the rural public health resources in the three regions. therefore, on the basis of ensuring the increase of the total supply of the rural public health resources, more attention should be paid to the improvement of the allocation efficiency. moreover, on the basis of continually narrowing the inter-regional differences among the eastern, central, and western regions, more attention should be paid to the intra-regional differences of the allocation efficiency of the rural public health resources among the different provinces. the various economic and social policies should be constantly optimized to jointly improve the allocation efficiency of the rural public health resources. people's health is an important symbol of national prosperity. with the rapid development of china's economy, the people's demand for health services is growing continually. to meet the demand, there must be a high-quality public health service system. as a developing country, china has a large rural population. the data from national bureau of statistics of the people's republic of china indicates that the rural population of the chinese mainland was million at the end of , accounting for . % of the total population. however, the per capita health expenditure of the rural residents was only yuan, accounting for only . % of the per capita health expenditure of the urban residents. several main indexes reflecting the public health situation in the rural areas, such as the total service amount of the public health, the diagnosis and treatment person-time, the utilization rate of hospital beds, and the number of beds in the township hospitals per person, showed a downward trend [ ] . according to the statistical information of national health commission of the people's republic of china, in recent years, with the continuous deepening of the poverty alleviation strategy, the proportion of poverty caused by diseases has not decreased, but increased from . % in to . % in . this shows that diseases have become one of the main reasons for the increase of poverty [ ] . the economist banerjee won the nobel prize in economics in for his contributions to global poverty alleviation through experimental methods. his research found that investment in the health of rural poor groups can improve their health level and then reduce the poverty caused by diseases [ ] . therefore, in consideration of the current urban and rural public health resource situation and the poverty alleviation, the rural public health career must be the top priority of the whole public health career development and therefore great importance should be attached to this. in addition, owing to the change of climate and environment as well as the increasingly frequent cross-border movements, the spread of infectious diseases has become ever more serious, such as the frequent occurrence of influenza including h n and h n in recent years and the attack of "dengue fever". in particular, the corona virus disease (covid- ) incident, which began at the end of , has brought a severe challenge to the rural public health service system of china. in the face of the increasingly growing health demand of the people and the impact of various public health emergencies, it is of great significance to study how to improve the allocation efficiency of the rural public health resources and ensure the effective supply of the rural public health resources. public health has always been the focus of attention in countries around the world. how to improve the effective allocation of the public health resources is the major problem facing most countries in the world [ ] . at the same time, it has also attracted the extensive attention from academia, and a large number of studies of the effective allocation of the public health resources have been carried out. some scholars have discussed the evaluation method of the hospital efficiency. for example, varabyova et al. [ ] and xu et al. [ ] comparatively analyzed the application of ratio analysis (ra), stochastic frontier analysis (sfa), and data envelopment analysis (dea) in the hospital efficiency evaluation. mitropoulos et al. [ ] and rouyendegh et al. [ ] respectively combined the dea method with bayesian analysis and fuzzy analytic hierarchy process (fahp) method to evaluate the hospital efficiency. due to the complexity of the public health resource supply, a single index cannot fully reflect its allocation efficiency. the dea method can be used to evaluate multiple input and output indexes, has become the first choice for scholars. at present, many scholars use the dea method to analyze the allocation efficiency of the public health resources from different angles, mainly including the following two aspects below. first, the hospital efficiency in different countries or regions is discussed by using the classical dea method from the microcosmic level. kawaguchi et al. [ ] , sohn et al. [ ] , chowdhury et al. [ ] , gholami et al. [ ] , flokou et al. [ ] , blatnik et al. [ ] , campanella et al. [ ] , and fuentes et al. [ ] respectively evaluated the hospital efficiency of developed countries or regions, namely japan, south korea, the united states, ontario, greece, slovenia, italy, and murcia of spain. jat et al. [ ] and gimenez et al. [ ] assessed the hospital efficiency of the developing countries india and colombia. other scholars have evaluated the hospital efficiency in china and some areas. hu et al. [ ] used the undesirable output dea method to evaluate china's regional hospital efficiency. cheng et al. estimated the efficiency of rural township hospital in xiaogan city of hubei province, china from to [ ] . zheng et al. evaluated the relative efficiency of the public hospitals in china after the implementation of new medical reforms [ ] . li et al. analyzed the determinants and differences of the township hospital efficiency among chinese provinces from to [ ] . other scholars have further discussed the impacts of management and organization [ ] , the medical reform [ , ] , and the increasing geographic elevation [ ] on hospital efficiency. second, the classical dea method is used to study the allocation efficiency of the public health resources among different countries and within a country from the macroscopic level. some scholars have evaluated and studied the efficiency of the public health systems in countries worldwide [ ] , the organization for economic co-operation and development (oecd) countries [ , ] , the low-and middle-income countries [ ] , and the asian countries [ ] . other scholars have estimated the public health efficiency in greece [ ] , india [ ] , lebanon [ ] , méxico [ ] , and slovakia [ ] . some scholars have deeply discussed china's public health efficiency, and respectively calculated and studied the chinese provincial community health service efficiency [ ] [ ] [ ] [ ] [ ] [ ] and the allocation efficiency of the public health resources in the coastal provinces of china [ ] . a few scholars have preliminarily analyzed the allocation efficiency of the rural public health resources [ , ] . after analyzing the allocation efficiency of the public health resources, some scholars further discussed the influencing factors. mitropoulos et al. and lee et al. assessed the impact of the public health policies on the health efficiency [ , ] . han et al. [ ] introduced such variables as population density, per capita gross domestic product (gdp), the residents' education level, the fiscal decentralization, and the healthcare system reform into the tobit model. zhang [ ] and liu [ ] incorporated fiscal decentralization, the medical and health system reform policies, per capita gdp, the residents' education level, the population density, and the urbanization level into the explained variables. guo et al. believe that the social, economic, and policy variables, such as the population density, the residents' education level, and the fiscal decentralization, are important reasons for the efficiency difference [ ] . to sum up, the research results of scholars such as kawaguchi [ ] , jat [ ] , li [ ] , liu [ ] , and xue [ ] on the measurement of the allocation efficiency of the public health resources and its influencing factors provide a great deal of experience as a reference for the study of this paper. compared with the existing studies, this paper has three main contributions. first, a comprehensive and systematic study on the regional differences and the causes of the allocation efficiency of the rural public health resources in china is conducted in this paper. although the existing studies cover multiple levels, they are less involved in the field of the rural public health, and there are even fewer studies that explore it from the perspective of regional differences. second, the game competition relationship is included in the evaluation model, and the improved game cross-efficiency model is used to replace the traditional dea model. this solves the problem of overestimating the allocation efficiency of the regional public health resources in the traditional dea model. third, when analyzing the influencing factors of the allocation efficiency of the rural public health resources, the traditional tobit regression model is replaced by the bootstrap truncated regression model. this solves the deviation problem of the classical tobit regression model when measuring the influencing factors of efficiency [ ] . consequently, this paper uses the game cross-efficiency model and theil index model to evaluate and analyze the regional differences and the causes of the allocation efficiency of the rural public health resources in provinces of china from to , and uses the bootstrap truncated regression model to find out the influencing factors, so as to provide the policy basis for improving the allocation efficiency of the rural public health resources in china. the game cross-efficiency model is an improvement to the traditional dea model. in the evaluation process of the traditional dea models, such as the charnes-cooper-rhodes (ccr) model [ ] and the banker-charnes-cooper (bcc) model [ ] , each decision making unit (dmu) tends to give more weight to itself so as to result in the overestimation of its efficiency. in order to overcome this shortcoming, sexton proposed a cross-efficiency dea model [ ] . based on the ccr model framework, the weight of mutual evaluation was added between dmus to correct the pure self-evaluation problem in the traditional ccr. however, as ccr and bcc models have more than one optimal weight, the cross-efficiency value is not unique. in order to solve this problem, liang et al. proposed a game cross-efficiency model. on the basis of solving the problem that the traditional ccr and bcc models cannot be effectively ordered, the game relationship between the evaluation units is introduced. while avoiding the secondary target selection of the cross-efficiency model, the strict assumption conditions of the traditional models are relaxed to make it more practical [ , ] . the main operation process of the model is as follows: assume that there are n dmu, and each decision-making unit dmu j obtains s outputs through m inputs. the i input and the r output of dmu j ( j = , · · · , n) is expressed, respectively, as x ij (i = , · · · , m) and y rj (r = , . . . , s) . first, the efficiency value of any evaluation unit dmu d under the ccr model is obtained by solving the following linear programming problem: ω id x ij ≤ , j = , , . . . , n µ rd ω id ≥ , r = , , . . . , s; i = , , . . . , m. ( ) in equation ( ), ω id and µ rd are respectively the i input weight and the r output weight of the evaluation unit dmu d . second, equation ( ) is used to solve the cross-efficiency e dj of dmu j taking dmu d as its weight: by solving equation ( ), the n sets of optimal weights ω * d , ω * d , . . . , ω * md and µ * d , µ * d , . . . , µ * sd can be obtained. then, all results of the cross-efficiency e dj constitute the following cross-efficiency matrix: therein, the elements on the main diagonal, e dd , d = , · · · n, are the optimum solution of the ccr model, namely the self-evaluation efficiency value of the traditional dea model. the elements on the off-diagonal are the cross-efficiency value that the decision-making unit dmu j ( j = , · · · , n, and j d) obtains by using the weight of dmu d . then, the cross-efficiency value of the decision-making unit dmu j ( j = , · · · , n) is the arithmetic mean value of the corresponding j column in the matrix: it should be noticed that the optimal weight of equation ( ) is not unique, and accordingly, the cross-efficiency value of the decision-making unit dmu d taking dmu d as its weight is not unique either. the final cross-efficiency is determined in the multiple optimum solutions by introducing the quadratic objective. meanwhile, because there is a direct or indirect competitive relation between each decision-making unit, the final efficiency value can be determined by game. it is assumed that there is a non-cooperative game relationship between participants and this relationship is reflected in the constraint conditions of the mathematical programming. suppose that the efficiency value of the participant dmu d is α d , and the remaining participant dmu j maximizes its own efficiency value while keeping the efficiency value of dmu d from being reduced. here, the game cross-efficiency value that dmu j obtains by using the weight of dmu d is defined as: in equation ( ), µ d rj and ω d ij are the feasible weights of the model, while α dj is the game cross-efficiency of dmu j for dmu d , and can be calculated by the following linear programming: in equation ( ), α d ≤ is the parameter. its initial value is the traditional cross-efficiency value, and its subsequent value can be calculated through the iterative algorithm. in summary, the game cross-efficiency value of dmu j is defined as: this paper applies the advanced maxdea uitra . software to solve the complex linear programming problem in the game cross-efficiency model. theil index model was originally proposed by theil to measure the differences between samples, and can effectively measure the contribution of the intra-and inter-group gaps to the total gap [ ] . this paper uses theil index model to measure the regional gap of the rural public health resource allocation efficiency in china. because of the additivity of theil index, the total regional differences are decomposed into the intra-regional differences and the inter-regional differences. first of all, the total regional differences of the allocation efficiency of the rural public health resources are measured by the total theil index (tl), and the methods of decomposing the theil index and its structure by bourguignon, cowell, and shorrocks are used for reference [ ] [ ] [ ] . thus, the calculation formula is tl = n n i= y i y log y i y . the intra-regional differences are measured by the intra-regional theil index, and the calculation formula is tl w = m k= n k n y k y tl k . the inter-regional differences are measured by the inter-regional theil index, and the calculation formula is n k n y k y log y k y . in the above formulas, y represents the allocation efficiency of the rural public health resources in each province, n represents the number of provinces, n k represents the number of provinces in k region. in addition, the ratio of the intra-regional theil index to the total theil index, namely, tl w /tl, represents the contribution rate of the intra-regional differences to the total regional differences. similarly, the ratio of the inter-regional theil index to the total theil index, namely tl b /tl represents the contribution rate of the inter-regional differences to the total regional differences. the gini index model proposed by dagum ( ) [ ] is used to analyze the differences in the allocation efficiency of the rural public health resources in china and its three regions. according to the gini index and its subgroup decomposition method proposed by dagum, the gini coefficient of the allocation efficiency of the rural public health resources in china can be defined as: thereinto, y hi (y jr ) is the allocation efficiency of the rural public health resources in h(j) region, y is the mean value of the allocation efficiency of the rural public health resources in each region, n is the number of provinces, k is the number of regions, n h (n k ) is the number of provinces in h(j) region, g is the total gini index, h and j are the different region division, and i and r are the different provinces in the region. according to the gini index decomposition method proposed by dagum, g = g w + g nb + g t . the regional difference of the allocation efficiency of the rural public health resources can be accordingly divided into three parts: g w represents the intra-regional difference contribution of the total differences of the allocation efficiency of the rural public health resources, g nb represents the inter-regional difference contribution of the total differences of the allocation efficiency of the rural public health resources, and g t represents the contribution of the intensity of transvariation of the inter-regional allocation efficiency of the rural public health resources. the specific calculation formula can be seen in the literature of dagum [ ] . the value range of the allocation efficiency of the rural public health resources is ( , ], and it belongs to the truncated data. if the least squares method is directly used for the regression analysis, the results will be biased and inconsistent. simar and wilson proved that the classic tobit regression model for processing the truncated data is not suitable for testing the influencing factors of efficiency, and accordingly proposed the bootstrap truncated regression model that can minimize the uncertainty of data and the statistical noise to overcome this limitation [ ] . the expression is as follows: in the equation ( ), θ i is the explained variable, β is the regression parameter, z i is the explanatory variable, and ε i obeys the normal distribution of n( , δ ), i = , , . . . , n. ( ) input index: the input index of the public health resources usually includes three main categories, that is, the health human resources, the health material resources and the health financial resources. in the design of the specific indexes, the number of doctors, nurses and beds are generally selected as the input indexes [ , ] . according to the statistical data of the health departments in china, considering the representativeness and accessibility of the input index, the number of personnel in the rural health institutions (the total number of doctors and nurses) is selected as an alternative index of the labor input, and the number of beds in the rural health institutions is selected as an alternative index of the material input. meanwhile, considering the fact that health institutions are the important spatial carrier for carrying out the health activities, the number of the rural health institutions is also used as another alternative index of the material input. although drugs are an important variable of the material input, they are mainly suitable for the hospital efficiency evaluation level. because it is difficult to obtain the regional data of drugs, they are not considered here. the rural medical and healthcare expenditure can provide the financial support for the rural health activities, and so it is selected as an alternative index of the financial input. ( ) output index: the final output of the public health resource input is the improvement of the population health. however, because of the complexity of the health improvement measurement and the difficulty of the data acquisition, some process indexes are usually used to replace it [ ] . according to the statistical data of the health departments in china, considering the representativeness and accessibility of the output index, the rural diagnosis and treatment person-time, the rural number of people receiving hospitalizations and the rural average hospitalization days are selected as the output indexes of the rural public health resources. see table for details. this paper applies maxdea uitra . software and selects the ccr model and the game crossefficiency model, and measures the average situation of the rural public health resource allocation efficiency of provinces in china from to under the two dea models, and calculates the efficiency variance value of the two models, as shown in figure . through the comparison between the ccr model and the game cross-efficiency model, it can be found that the efficiency value measured by the ccr model is obviously higher than that of the game cross-efficiency model. from the perspective of the national level, the efficiency value ( . ) measured by the ccr model is higher than that ( . ) of the game cross-efficiency model, which is . % higher on average. from the perspective of the eastern, central, and western regions, the efficiency value measured by the ccr model is respectively . , . , and . and is higher than that ( . , . , and . ) measured by the game cross-efficiency model, which is . %, . %, and . % higher, respectively. from the perspective of each province, the efficiency value measured by the ccr model is higher than that of the game cross-efficiency model, and the higher range is slightly different. this paper uses the deviation to measure the range that the ccr model is higher than the game cross-efficiency model. as shown in figure , the deviation in tibet is the highest, and the efficiency value measured by the ccr model is . however, after it is proofread by the game cross-efficiency model, the actual efficiency value is only . and the deviation is as high as . %. generally speaking, if the game relationship between each region is not taken into consideration, the measured efficiency value of the rural public health resource allocation in each province will be exaggerated, and is not consistent with the actual situation of the rural public health resource allocation. in order to solve this problem, this paper uses the game cross-efficiency model to measure the allocation efficiency of the rural public health resources in provinces in china, and truly reveals this paper applies maxdea uitra . software and selects the ccr model and the game cross-efficiency model, and measures the average situation of the rural public health resource allocation efficiency of provinces in china from to under the two dea models, and calculates the efficiency variance value of the two models, as shown in figure . through the comparison between the ccr model and the game cross-efficiency model, it can be found that the efficiency value measured by the ccr model is obviously higher than that of the game cross-efficiency model. from the perspective of the national level, the efficiency value ( . ) measured by the ccr model is higher than that ( . ) of the game cross-efficiency model, which is . % higher on average. from the perspective of the eastern, central, and western regions, the efficiency value measured by the ccr model is respectively . , . , and . and is higher than that ( . , . , and . ) measured by the game cross-efficiency model, which is . %, . %, and . % higher, respectively. from the perspective of each province, the efficiency value measured by the ccr model is higher than that of the game cross-efficiency model, and the higher range is slightly different. this paper uses the deviation to measure the range that the ccr model is higher than the game cross-efficiency model. as shown in figure , the deviation in tibet is the highest, and the efficiency value measured by the ccr model is . however, after it is proofread by the game cross-efficiency model, the actual efficiency value is only . and the deviation is as high as . %. generally speaking, if the game relationship between each region is not taken into consideration, the measured efficiency value of the rural public health resource allocation in each province will be exaggerated, and is not consistent with the actual situation of the rural public health resource allocation. in order to solve this problem, this paper uses the game cross-efficiency model to measure the allocation efficiency of the rural public health resources in provinces in china, and truly reveals the actual situation of the allocation efficiency of the rural public health resources in each province of china. next, the game cross-efficiency model will be used to analyze the allocation efficiency situation of the rural public health resources in china in detail. from the perspective of the regional comparison, it shows a gradient trend that "the allocation efficiency in the eastern region is high, the allocation efficiency in the western region is low, and the allocation efficiency in the central region is at the medium level", and this conclusion is similar to the research results of jiang et al. [ ] . however, the gap among the three regions is continually narrowing. the efficiency value in the eastern, central, and western regions from to is respectively . , . , and . , and presents a state that "the efficiency value in the eastern region is the highest, the efficiency value in the western region is the lowest, and the efficiency value in the central region is at the medium level" as a whole. from the perspective of different years, the gap among regions is continually narrowing. in , the eastern region with the highest efficiency value was . higher than the western region with the lowest efficiency value. the gap between the two regions had been continually narrowing since then, and the eastern region was only . higher than the western region in . the allocation efficiency value of the rural public health resources (aev) in provinces of china is divided into three grades: high-efficiency (aev > = . ), medium-efficiency ( . > aev > = . ) and low-efficiency (aev < . ). on this basis, gis . from the perspective of the regional comparison, it shows a gradient trend that "the allocation efficiency in the eastern region is high, the allocation efficiency in the western region is low, and the allocation efficiency in the central region is at the medium level", and this conclusion is similar to the research results of jiang et al. [ ] . however, the gap among the three regions is continually narrowing. the efficiency value in the eastern, central, and western regions from to is respectively . , . , and . , and presents a state that "the efficiency value in the eastern region is the highest, the efficiency value in the western region is the lowest, and the efficiency value in the central region is at the medium level" as a whole. from the perspective of different years, the gap among regions is continually narrowing. in , the eastern region with the highest efficiency value was . higher than the western region with the lowest efficiency value. the gap between the two regions had been continually narrowing since then, and the eastern region was only . higher than the western region in . the allocation efficiency value of the rural public health resources (aev) in provinces of china is divided into three grades: high-efficiency (aev ≥ . ), medium-efficiency ( . > aev ≥ . ) and low-efficiency (aev < . ). on this basis, gis . software is used to draw the spatial distribution map of the allocation efficiency of the rural public health resources in china in , , , and , as shown in figure . in , the allocation efficiency of the rural public health resources showed an obvious aggregation effect of "the high-efficiency province aggregation and the low-efficiency province aggregation" [ ] . in terms of high-efficiency, there are provinces with high-efficiency, including six provinces in the eastern region, three provinces in the central region, and four provinces in the western region. in terms of low-efficiency, there are provinces with low-efficiency, accounting for % of provinces. these provinces with low efficiency are mainly concentrated in the central and western regions, including seven provinces in the western region, three provinces in the central region, and four provinces in the eastern region. there are four provinces with medium efficiency, that is, shanghai, hubei, hunan and yunnan, and their distribution is relatively scattered. in , the allocation efficiency of the rural public health resources showed an obvious aggregation effect of "the high-efficiency province aggregation and the low-efficiency province aggregation" [ ] . in terms of high-efficiency, there are provinces with high-efficiency, including six provinces in the eastern region, three provinces in the central region, and four provinces in the western region. in terms of low-efficiency, there are provinces with low-efficiency, accounting for % of provinces. these provinces with low efficiency are mainly concentrated in the central and western regions, including seven provinces in the western region, three provinces in the central region, and four provinces in the eastern region. there are four provinces with medium efficiency, that is, shanghai, hubei, hunan and yunnan, and their distribution is relatively scattered. because of the unbalanced development of china's economy, the supply of the rural public health resources in different provinces showed an unbalanced state in , and accordingly resulted that the allocation efficiency of the rural public health resources presented an obvious unbalanced trend of "the high-efficiency province reduction, the medium-and low-efficiency province expansion". the number of the high-efficiency provinces shrank from to six, with hebei in the eastern region becoming a low-efficiency province and six provinces becoming the medium-efficiency provinces, namely, zhejiang, fujian, and shandong in the eastern region, anhui and henan in the central region, and guangxi in the western region. with this change, the number of the low-efficiency provinces increased to and the number of the medium-efficient provinces increased to . in , because of the implementation of the regional coordinated development strategy, the supply of the rural public health resources tended to balance, and the unbalanced trend of "the high-efficiency province reduction, the medium-and low-efficiency province expansion" presented by the allocation efficiency of the rural public health resources was eased. the number of the low-efficiency provinces had no changes and was still . the number of the medium-efficiency provinces shrank to seven. the number of the high-efficiency provinces had an obvious increase, from six to nine. although the regional coordinated development strategy has been continuously deepened, the allocation efficiency condition of the rural public health resources in is the same as that in . in short, the unbalanced problem of the rural public health resource supply is still noticeable. there is a long way to further reform the allocation of the rural public health resources. in order to further explore the source of the regional differences in the allocation efficiency of the rural public health resources in china, the theil index model and gini index model are used to measure the regional differences and their sources in the allocation efficiency of the rural public health resources in china. figure presents the total theil index and the total gini index of the regional differences in the allocation efficiency of the rural public health resources in china from to . the total theil index is slightly higher than the total gini index, and they show the same change rule. the regional differences in the allocation efficiency of the rural public health resources in china show an inverted u-shaped development trend, first rising and then falling as a whole. specifically, the total theil index of the allocation efficiency of the rural public health resources was the lowest in , and was only . . then it was in a rising condition from - and rose to . in . this is because china launched the rural medical and health system reform in , but the impact of the financial crisis led to the different promotion speed of the rural medical and health system reform in different provinces, and then resulted in an increasingly expanding total theil index of the allocation efficiency of the rural public health resources among different provinces. the rural medical and health system reform of different provinces had entered a stable period after , and the policy effect was beginning to gradually appear. the total theil index of the allocation efficiency of the rural public health resources was tending to shrink and had fallen slightly after , and rose slightly in . through the comparison, it is found that the changing trend of the intra-regional and inter-regional differences in the allocation efficiency of the rural public health resources are basically consistent with that of the total regional differences. table presents the theil index decomposition and the gini index decomposition of the regional differences in the allocation efficiency of the rural public health resources in china from to . from to , the average contribution rate of the intra-regional differences measured by the theil index is . % and much higher than that of the inter-regional differences ( . %), while the average contribution rate of the intra-regional differences measured by the gini index is . % and also much higher than that of the inter-regional differences ( . %). this shows that the intraregional differences have become the major source of the regional differences in the allocation efficiency of the rural public health resources in china. this is because, since , the chinese government has attached great importance to the equalization of the inter-regional rural public health resource supply, and has put forward a new round of regional coordinated development policies, such as western development, the overall revitalization of the old industrial bases in the northeast china, and the rise of the central china, especially increasing support for the ethnic minority areas, the border areas, and the poor areas, and has fully implemented a series of health poverty alleviation policies. those play an important role in promoting the optimal allocation of the regional rural public health resources. as the complex natural geographical situation, economic conditions, and social background among provinces within different regions, there is a great difference in the improvement degree of the allocation efficiency of the rural public health resources. the intra-regional differences become the major cause of the regional differences in the allocation efficiency of the rural public health resources in china. china's economy has gradually recovered from the financial crisis after , but the recovery degree varies in different regions. the economically developed eastern region is recovering faster than the central and western regions. the contribution rate of the inter-regional differences of the allocation efficiency of the rural public health resources had presented a sustained rising state after , and the inter-regional theil index and gini index rose to . % and . % separately in . the result shows that if the inter-regional differences in the allocation efficiency of the rural public health resources are allowed to expand, it will not only deviate from the coordinated development goal of the regional rural public health resources, but also increase the difficulty of the coordinated development of the regional rural public health resources. table presents the theil index decomposition and the gini index decomposition of the regional differences in the allocation efficiency of the rural public health resources in china from to . from to , the average contribution rate of the intra-regional differences measured by the theil index is . % and much higher than that of the inter-regional differences ( . %), while the average contribution rate of the intra-regional differences measured by the gini index is . % and also much higher than that of the inter-regional differences ( . %). this shows that the intra-regional differences have become the major source of the regional differences in the allocation efficiency of the rural public health resources in china. this is because, since , the chinese government has attached great importance to the equalization of the inter-regional rural public health resource supply, and has put forward a new round of regional coordinated development policies, such as western development, the overall revitalization of the old industrial bases in the northeast china, and the rise of the central china, especially increasing support for the ethnic minority areas, the border areas, and the poor areas, and has fully implemented a series of health poverty alleviation policies. those play an important role in promoting the optimal allocation of the regional rural public health resources. as the complex natural geographical situation, economic conditions, and social background among provinces within different regions, there is a great difference in the improvement degree of the allocation efficiency of the rural public health resources. the intra-regional differences become the major cause of the regional differences in the allocation efficiency of the rural public health resources in china. china's economy has gradually recovered from the financial crisis after , but the recovery degree varies in different regions. the economically developed eastern region is recovering faster than the central and western regions. the contribution rate of the inter-regional differences of the allocation efficiency of the rural public health resources had presented a sustained rising state after , and the inter-regional theil index and gini index rose to . % and . % separately in . the result shows that if the inter-regional differences in the allocation efficiency of the rural public health resources are allowed to expand, it will not only deviate from the coordinated development goal of the regional rural public health resources, but also increase the difficulty of the coordinated development of the regional rural public health resources. table . theil index decomposition and gini index decomposition of regional differences and their sources of allocation efficiency of rural public health resources in china from to . gini index source of differences contribution rate (%) total g source of differences contribution rate (%) intra-regional inter-regional intra-regional inter-regional note: g w is the intra-group differences, g nb is the inter-group differences, and g t is the differences of the intensity of transvariation; g = g w + g nb + g t . in addition, the gini index also provides the specific decomposition of the regional differences in the allocation efficiency of the rural public health resources in china, as shown in table . from the perspective of the inter-regional differences, the differences between the eastern and western region are the largest, followed by the differences between the eastern and central region, and the differences between the central and western region are the smallest. from the perspective of the change rule, with the implementation of strategies such as western development and the rise of the central china, the differences between the central and western region are narrowing. however, due to the agglomeration effect and policy advantages of the economic development in the eastern region, the differences between the eastern and central regions and the differences between the eastern and western regions have been maintaining a very high level. from the perspective of the intra-regional differences, because the economic development level and the location characteristics are very similar, the gini index of the regional differences in the allocation efficiency of the rural public health resource among provinces in the central region is the smallest, and the gap is generally narrow during the research period. there are great differences in each province within the eastern and western regions and their gini index has been maintaining a very high level, and the gap is generally expanding during the research period. table . gini index decomposition of regional differences in allocation efficiency of rural public health resources in china from to . year inter-regional gini index intra-regional gini index through the calculation result of the allocation efficiency of the rural public health resources in china, it is found that the allocation efficiency of the rural public health resources in china is relatively low and the interregional differences are noticeable. next, this paper will further study the major factors that affect the change of the allocation efficiency of the rural public health resources in china. drawing on the research results of the existing literature, this paper indicates that the allocation efficiency of the rural public health resources is mainly affected by the economic and social factors, as follows in detail: ( ) economic factors. according to the relevant literature, this paper mainly investigates the three economic variables including the economic development level, the living conditions, and the governmental financial support. first, the economic development level is expressed by the per capita gdp (yuan). it is generally believed that the economic development of a region can provide the strong support for the rural public health expenditure. second, the living conditions are expressed by the per capita disposable income of rural residents (yuan). it is generally believed that the higher the living standard of rural residents, the higher the cognition and demand for the public health resources. third, the governmental financial support is expressed by the proportion of the public health expenditure to the total fiscal expenditure. it is generally believed that the higher the public health expenditure, the more likely to cause the waste of funds and the lax management, resulting in the low allocation efficiency. ( ) social factors. according to common practice of the existing literature, the social factors affecting the public health expenditure are mainly considered from four aspects: the population quantity, the population quality, the population structure, and the social support level. first, the population quantity reflects the demand degree for the public health resources, and then affects the governmental public health expenditure and the allocation efficiency of the public health resources. it is measured by the population density index and is expressed by the number of people per square kilometer in the rural areas. second, the population quality in an area is mainly reflected in the education level of population. the lower the education level of residents, the lower the cognition and demand for the public health resources, resulting in a lower allocation efficiency of the rural public health resources. the education level is concretely expressed by the proportion of illiterate persons to the rural population aged and above. third, the population structure will affect the demand for the public health resources and the fiscal expenditure. the larger the urban population in a region, the more public health resources need to be invested in cities, and then the supply and management of the rural public health resources are ignored, resulting in the decline of the allocation efficiency. the population structure is measured by the urbanization level and is concretely expressed by the proportion of the urban population to the total population. fourth, the social support level reflects the major demand groups of the rural public health resources in a region. it is expressed by the proportion of the rural children, youth, and the elderly population to the total population. the higher the social support level, the higher the demand for the rural public health resources, which will lead to the improvement of the allocation efficiency. next, this paper takes seven aspects as the influencing factors of the allocation efficiency of the rural public health resources, that is, the economic development level, the living conditions, the governmental financial support, the population density, the education level, the urbanization level, and the social support level. according to the regional classification standard of the eastern, central, and western regions, the target samples are selected to construct a quantitative model between the allocation efficiency and the influencing factors of the rural public health resources, so as to quantify and analyze the influence of each factor on the allocation efficiency of the rural public health resources in china and its three regions. because the value range of the allocation efficiency of the rural public health resources is ( , ], this paper uses the bootstrap truncated regression model that can minimize the uncertainty of data and the statistical noise to estimate the parameters. stata software is used in the regression process. through calculation, it can be seen that the r-squared value and the adj r-squared value of the four models are bigger than . , and the overall goodness of fit of models is good. the estimation results are shown in table . ( ) there are the regional differences in the impact of the economic development level on the allocation efficiency of the rural public health resources. the eastern and western regions have passed the % significance test, and the regression coefficient is respectively . and − . . this indicates that the variable promotes the allocation efficiency of the rural public health resources in the eastern region and hinders that in the western region. for the eastern region, the improvement of the economic development level enables more rural residents to enjoy the fruits of the economic development and obtain more public health resources. for the western region, although the economy has developed, the city-centric unbalanced development strategy will make the government invest more resources in the urban development. not only is the supply of the rural public health resources insufficient, but the allocation efficiency is also low. the nationwide and the central regions have not passed the significance test. ( ) there are the regional differences in the impact of the living conditions on the allocation efficiency of the rural public health resources. the living condition variable in the nationwide, eastern, and western regions has all passed the % significance test except for that in the central region, and the regression coefficient is respectively . , − . , and . . this indicates that the variable promotes the allocation efficiency of the rural public health resources in the nationwide and western regions, and hinders that in the eastern region. as a developing country, china has a large proportion of rural residents with poor living conditions. with the implementation of the national poverty alleviation strategy, the living conditions of rural residents have been improved and the demand for the public health resources has increased, and then the allocation efficiency of the rural public health resources has been improved. the improvement of the living conditions has greatly increased the demand for the public health resources and has a bigger improvement effect on the allocation efficiency of the rural public health resources, especially in the western region with the relatively low per capita disposable income of rural residents. however, the per capita disposable income of rural residents in the eastern region is very high, and they pay more attention to their own health and are less likely to get sick. the further improvement of the living standards reduces the allocation efficiency of the rural public health resources instead. , and all of them have passed the % and below significance test except for that in the central region. this shows that with the increase of the total financial inputs into the public health in china, the rural public health expenditure is also increasing year by year. however, the system and mechanism problem of the public health management gives rise to the spatial imbalance of the public health resource supply, and accordingly leads to the mismatch between supply and demand and distorts the allocation efficiency of the rural public health resources. ( ) the population density plays a promotion role in improving the allocation efficiency of the rural public health resources in china. the population density variable in the nationwide, eastern, and western regions has all passed the % and below significance test except for that in the central region, and the regression coefficient is respectively . , . , and . . this is mainly because the high population density brings the scale efficiency to the utilization of the rural public health resources, and then improves the allocation efficiency of the rural public health resources. ( ) the education level plays a promotion role in improving the allocation efficiency of the rural public health resources in china. the regression coefficient of the education level variable in the nationwide, eastern, central, and western regions is respectively − . , − . , − . , and − . , and all have passed the % and below significance test. this indicates that the higher the illiterate person rate in rural residents, the lower the allocation efficiency of the public health resources. with the higher education level of villagers, the greater the demand for the public health resources. this is conducive to the effective allocation of the rural public health resources. resources. therefore, the higher the rural social support level, the higher the demand for the rural public health resources, and the more fully the rural public health resources may be utilized. and then improve the allocation efficiency of the rural public health resources. note: z value is expressed in brackets; * represents % significance level, ** represents % significance level, *** represents % significance level. bootstrap method is used to set the sample number of times. in this paper, the game competition relationship is included in the evaluation model, and the game cross-efficiency model is used to measure the allocation efficiency of the rural public health resources in provinces of china from to . then, the theil index model and the gini index model are applied in exploring the regional differences in the allocation efficiency of the rural public health resources and its sources. finally, the bootstrap truncated regression model is used to analyze the influencing factors of the allocation efficiency of the rural public health resources in china. the major conclusions are as follows: ( ) the total allocation efficiency level of the rural public health resources in china from to is relatively low, and it presents a u-shaped trend of first falling and then rising. ( ) the changing trend of the allocation efficiency of the rural public health resources in the eastern, central, and western regions of china from to is similar to that in the nationwide region, and it shows a gradient trend that "the allocation efficiency in the eastern region is high, the allocation efficiency in the western region is low, and the allocation efficiency in the central region is at the medium level". however, the gap among the three regions is continually narrowing. ( ) because of the unbalanced development of china's economy, the supply of the rural public health resources in different provinces showed an unbalanced state, and accordingly resulted that the allocation efficiency of the rural public health resources presented an obvious unbalanced trend of "the high-efficiency province reduction, the medium-and low-efficiency province expansion". with the continuous deepening of the regional coordinated development strategy, the supply of the rural public health resources tended to balance, and the unbalanced trend of the allocation efficiency of the rural public health resources was eased. however, the unbalanced problem of the rural public health resource supply is still noticeable. ( ) to judge from the source of the regional differences, from to , the average contribution rate of the intra-regional differences measured by the theil index is . % and much higher than that of the inter-regional differences ( . %), while the average contribution rate of the intra-regional differences measured by the gini index is . % and also much higher than that of the inter-regional differences ( . %). this shows that the intra-regional differences have become the major source of the regional differences in the allocation efficiency of the rural public health resources in china. however, the contribution rate of the inter-regional differences had presented a sustained rising state after , and it cannot be ignored. ( ) the improvement of the education level and the social support level will generally improve the allocation efficiency of the rural public health resources in china and its three regions. the improvement of the governmental financial support and the urbanization level will reduce the allocation efficiency of the rural public health resources in china and its three regions. the economic development level, the living conditions and the population density are the important influencing factors of the allocation efficiency differences of the rural public health resources in the three regions. the above research results can provide the policy basis for improving the allocation efficiency of the rural public health resources in china. first, the health poverty alleviation project should be deeply implemented to ensure that the rural poor population enjoys the basic medical and health services, and prevent the poverty caused by diseases. the prices of the rural public health products should be continuously reduced, and the government should provide the corresponding free health preventive services, or subsidize families who take the initiative to take the health preventive services, so that the rural population can get the health preventive services as easily as possible. by constantly perfecting the national poverty alleviation strategy and policy system, the organic connection between the health services and the poverty alleviation can be realized, and the incidence of the rural poverty can be greatly reduced. second, the healthy china strategy should be further pushed forward, and more attention should be paid to the improvement of the allocation efficiency on the basis of ensuring the growth of the total supply of the rural public health resources. on one hand, the city-centric supply mode of the public health resources should be changed, the public health resources should be constantly pushed forward to tilt to the rural areas, and the system reform of the new rural cooperative medical insurance should be deepened. the hierarchical diagnosis and treatment system reform of china should be actively pushed forward, and it should be ensured that the high-quality medical resources can enter the rural areas to make the rural residents share the public health and economic development fruits. on the other hand, the system and mechanism reform of the rural public health resource supply should be deepened, restructuring of the rural grass-roots medical institutions should be pushed further forward, and the medical community should be established. a large information sharing platform of the urban and rural medical systems should be established to achieve the continuous records of the electronic health archives and the electronic medical records of the rural residents as well as the information sharing among different levels and types of medical institutions, so as to improve the accessibility of the high-quality medical resources and the total medical service efficiency. third, on the basis of continually narrowing the inter-regional differences among the eastern, central, and western regions, more attention should be paid to the intra-regional differences of the allocation efficiency of the rural public health resources among the different provinces. on one hand, the regional rural public health coordinated development strategy should be thoroughly implemented, and the mechanism and system reform of the rural public health resource supply within the region should be coordinated and pushed forward, so as to constantly promote the spatial balanced development of the rural public health resource supply. on the other hand, the regulatory mechanism and the accountability mechanism of the rural public health funds should be established and perfected, and efforts should be made to establish an efficiency-oriented regional rural public health resource supply mechanism, so as to constantly narrow the regional differences in the allocation efficiency of the rural public health resources and realize the effective match for supply and demand of the rural public health resources. fourth, various economic and social policies should be constantly optimized to jointly improve the allocation efficiency of the rural public health resources. first of all, each region should increase the investment in the rural education and constantly improve the education level of rural residents, so as to improve their demand for and utilization rate of the rural public health resources. secondly, each region should follow up and pay attention to the rural unoccupied village phenomenon caused by the improvement of the urbanization level, and duly adjust the layout of the rural public health resource supply, so as to avoid the efficiency loss caused by the idle rural public health resources. thirdly, the rural revitalization strategy should be accelerated. each region should promote the transformation of the unoccupied villages into the gathered 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miranda-schaeubinger, monica; blumfield, einat; chavhan, govind b.; farkas, amy b.; joshi, aparna; kamps, shawn e.; kaplan, summer l.; sammer, marla b. k.; silvestro, elizabeth; stanescu, a. luana; sze, raymond w.; zerr, danielle m.; chandra, tushar; edwards, emily a.; khan, naeem; rubio, eva i.; vera, chido d.; iyer, ramesh s. title: a primer for pediatric radiologists on infection control in an era of covid- date: - - journal: pediatr radiol doi: . /s - - - sha: doc_id: cord_uid: iy o pediatric radiology departments across the globe face unique challenges in the midst of the current covid- pandemic that have not been addressed in professional guidelines. providing a safe environment for personnel while continuing to deliver optimal care to patients is feasible when abiding by fundamental recommendations. in this article, we review current infection control practices across the multiple pediatric institutions represented on the society for pediatric radiology (spr) quality and safety committee. we discuss the routes of infectious transmission and appropriate transmission-based precautions, in addition to exploring strategies to optimize personal protective equipment (ppe) supplies. this work serves as a summary of current evidence-based recommendations for infection control, and current best practices specific to pediatric radiologists. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. a cluster of patients with severe viral pneumonia was first described in wuhan, china, in december . the following month, genome sequencing of the virus isolated from a patient's lower respiratory tract revealed the pathogen to be a novel coronavirus, now known as severe acute respiratory syndrome coronavirus (sars-cov- ), causing the disease covid- (coronavirus disease ) [ , ] . since first described, covid- has spread rapidly across the globe; it was declared a pandemic by the world health organization (who) on march , [ ] . as our understanding of covid- evolves, hospitals around the world have been rapidly modifying practice guidelines. each institution struggles with maintaining the critical balance between resource availability and safety for staff and patients. pediatric radiology departments are inextricably linked to this struggle because urgent diagnostic imaging and image-guided procedures continue despite reduction in outpatient volume. the goal of the authors in this paper is to review current infection control practices in the literature and online across the multiple institutions that represent the society for pediatric radiology (spr) quality and safety committee. the discussion is informed by current evidence and societal guidelines, though these concepts may change with time. additional information is available in the online supplementary material regarding examples of institutional practices for personal protective equipment (ppe) usage depending on covid- status, as well as tutorials for donning and doffing ppe. put succinctly, the current concern for most pediatric radiologists is this: what level of ppe is required for a mask-off, likely aerosol-generating procedure in a child of uncertain covid- status? the answer is complex and varies based on institutional guidelines and equipment availability. this paper better informs the radiologist's decision during such an encounter. infections are commonly transmitted by contact, droplet and airborne routes (tables and ) [ , ] . contact transmission occurs when infectious organisms are transferred from an infected person to a susceptible individual, either directly through physical contact, or indirectly via contaminated objects (e.g., us transducer, fluoroscopy table, doorknob, computer mouse); susceptible individuals could then inoculate themselves by touching their eyes, nose or mouth with contaminated fingers. droplet transmission occurs when larger infectious particles (> μm) travel from the infected individual to the mucosal surfaces of a susceptible person's eyes, nose or mouth; droplets might travel in the air as far as ft. airborne transmission occurs when smaller infectious particles (generally < μm), known as aerosols, remain suspended in the air for prolonged periods ranging from minutes to days; these particles might contact mucosal surfaces or be inhaled. importantly, an organism might be spread by more than one of these routes. for example, there is strong evidence of influenza virus transmission by droplet, airborne and contact modes [ ] . these pathogenic particles are absorbed via the respiratory mucosa and potentially across the conjunctivae. both droplets and aerosols can be generated during coughing, sneezing, talking and exhaling, which generates different numbers of respiratory particles. the particle size and infective capacity also varies among these activities. coughing and sneezing expel a cloud of respiratory particles of many different sizes, ranging from . μm to greater than μm [ ] [ ] [ ] . a sneeze generally contains more particles than a cough [ ] . although particles are somewhat arbitrarily categorized as either aerosols or droplets, their behavior varies along a spectrum. for example, settling times (i.e. the time it takes particulate matter to fall m, or approximately the height of a room) for particles of different diameters are s for μm, min for μm, min for μm, and min for μm [ ] . this behavior can be further affected by environmental factors like airflow and humidity [ ] [ ] [ ] . aerosols typically travel longer distances in the air and are more likely to be inhaled deeper in the lungs, while larger droplets are typically trapped in the upper airways [ , ] . airflow dynamics of coughing, sneezing, breathing, speaking, toilet flushing and even vomiting have been studied and shown to generate aerosols [ ] , but there is little available evidence regarding airflow dynamics of many other processes that might be encountered by the pediatric radiologist, such as crying, burping and passing flatus. the most common symptoms of covid- include fever, cough, dyspnea, fatigue and myalgia [ , ] . patients might also experience headache, loss of smell or taste, nasal congestion and gastrointestinal symptoms (e.g., vomiting, diarrhea) [ , ] . about - % of affected adults progress to severe pneumonia, adult respiratory distress syndrome (ards) and respiratory failure [ , ] . reported mortality rates among different countries range . - . %, including an estimated . % mortality rate in the united states, though these figures might be inaccurate because there could be a large number of people with the disease who have not been tested [ ] . in children, covid- is generally milder than in adults, and gastrointestinal symptoms are more prevalent [ , ] . as of this writing, the etiology and pathophysiology of the newly identified multisystem inflammatory syndrome in children (mis-c) associated with covid- have not yet been elucidated (https://www.cdc.gov/coronavirus/ -ncov/daily-lifecoping/children/mis-c.html). children younger than years account for only % of severely affected patients. however, of greater public concern, children might be asymptomatic viral carriers and transmit the disease to more vulnerable individuals [ ] . the sars-cov- virus binds to the angiotensin-converting enzyme- (ace ) receptor, which is abundant in respiratory epithelial cells [ ] , accounting for the high prevalence of respiratory symptoms in this disorder. before it reaches the lungs, the virus must first come in contact with mucosal cells in the lips, nasal cavity, or conjunctivae that also express the ace receptor [ ] . ace receptors are also expressed in the gastrointestinal tract, which might explain the gastrointestinal symptomatology occurring in - % of patients. this might be of special interest in children in whom gastrointestinal symptoms are more common [ ] . our understanding of the virus is still growing, but early data suggest that sars-cov- is primarily spread through the respiratory droplets of sick individuals. there is still concern that airborne transmission occurs; data from the university of nebraska have demonstrated aerosolization of the virus both within and outside the rooms of patients hospitalized with covid- [ ] . it is also clear that asymptomatic infection occurs. while it is uncertain to what degree asymptomatic people transmit the virus, these individuals can have high viral loads in their airway [ , ] , and the virus can be recovered from the environment that they inhabit [ , ] . this potential for airborne transmission of sars-cov- is particularly concerning for pediatric radiology departments regarding aerosol-generating procedures (discussed later). although viral load for covid- is certainly the highest in sputum and upper respiratory secretions, another potential route of transmission is through viral shedding in stool. several studies demonstrated the presence of viral ribonucleic acid (rna) in - % of stool samples of covid- patients, with persistence of viral rna in the stool even after respiratory samples became negative. furthermore, it was found that stool samples were positive at a higher rate in patients who experienced diarrhea [ ] [ ] [ ] [ ] . although viral rna is present in covid- patients' stool, feco-oral transmission has not been documented, and there is no convincing evidence of viable pathogenic sars-cov- particles cultured from these stool samples. aerosol-generating medical procedures are increasingly recognized as a source of nosocomial infections that pose risk for health care professionals, particularly in the covid- era. many procedures performed by radiologists have the potential of inducing aerosol formation by patients either with coughing, or with aerosolization of bowel contents. aerosolgenerating procedures may be classified as: ( ) procedures that mechanically create and disperse aerosols and ( ) procedures that induce the patient to produce aerosols. the first classification includes nebulizer treatment, suctioning, manual ventilation and noninvasive ventilation (e.g., bilevel positive airway pressure, continuous positive airway pressure, and high-frequency oscillatory ventilation). the second classification includes endotracheal intubation, bronchoscopy, cardiopulmonary resuscitation, and sputum induction (produced by the patient coughing) [ ] . personal protective equipment (ppe) ( table ) the purpose of wearing ppe is to minimize exposure to hazards that can cause injuries and illnesses in the workplace [ ] . the use of ppe should meet standards specifically developed for each exposure risk level of a particular task. in the context of the current covid- pandemic, it is of utmost importance that each workplace prepares for the corresponding levels of exposure defined by the occupational safety and health administration [ ] . in pediatric radiology departments, the risk involved ranges from low (e.g., office workers, remote workers, telemedicine) to very high (e.g., workers performing aerosol-generating procedures on known or suspected covid- patients), depending on the job task assigned [ , ] . when caring for anyone with confirmed or suspected sars-cov- infection, health care personnel should adhere to standard and transmission-based precautions [ ] [ ] [ ] . the preferred ppe for these covid- precautions includes a face shield or goggles, a n or higher respirator, non-sterile gloves and an isolation gown ( fig. , online supplementary material and ) [ ] . the u.s. department of labor's occupational safety and health administration has established the following standards for eye and face protection (these are designated as cfr . ) [ ] . & eye protection: goggles or shields can be used to protect from splashes of blood and body fluids [ , ] . eye glasses and contact lenses do not meet requirements for eye protection but may be used underneath goggles or shield [ ] . reusable eye protection should be cleaned and disinfected prior to reuse [ ] . & face shields: face shields are used to protect the facial area and associated mucous membranes, and must cover the front and sides of the face [ , ] . while there is no current standard for face/eye protection for airborne pathogens, the current recommendations by the occupational safety and health administration for bloodborne pathogens include "masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields" [ , ] . face shields have been shown to reduce a respirator's contamination by % and to block % of inhalational exposure immediately after a cough ( . μm particles at a distance of in.) [ ] . & surgical masks: surgical masks are loose-fitting disposable devices. these masks protect the wearer's mouth and nose with a physical barrier [ ] . surgical masks are fluidresistant, and they guard others from the wearer's respiratory emissions (> μm) [ ] . these masks also protect against large droplets, splashes and sprays of bodily or other hazardous fluids. & respirators: respirators are used to reduce the risk of inhaling hazardous airborne particles, gases or vapors, and should cover at least the nose and mouth [ ] . respirators • extended use of equipment • use of alternate equipment (e.g., cloth gowns, coveralls, equipment meeting international standards) • selectively cancel elective and non-urgent procedures and appointments for which eye protection is typically required • shift eye protection supplies from disposable to reusable devices such as goggles and face shields • selectively cancel elective and non-urgent procedures and appointments for which facemask, gown or eye protection is typically used by the provider • prioritize use of facemask, gown and eye protection equipment by activity type (use during aerosol-generating procedures or other high-contact patient care activities) • consider using safety glasses (e.g., trauma glasses) that have extensions to cover the side of the eyes • reprocess eye protection with effective cleaning methods when no equipment is available • exclude provider at higher risk for severe illness from covid- (e.g., immunocompromised) from contact with known or suspected covid- patients • designate convalescent provider for provision of care to known or suspected covid- patients • consider using gown alternatives that have not been evaluated as effective (preferably with long sleeves and closures such as snaps, buttons) • if facemask not available, consider: use of face shield that covers the entire front (extends to the chin or below) and sides of the face with no facemask; use of expedient patient isolation rooms for risk reduction; use of ventilated headboards, and provider use of homemade masks (e.g., bandana, scarf) protect either by removing contaminants from the air or by supplying clean air from a different source [ ] . they are certified by the centers for disease control and prevention (cdc) and the national institute for occupational safety and health (niosh) [ ] . & n respirators: these masks are filtering facepiece respirators (ffr) that efficiently filter out at least % of large and small (≥ . μm) airborne particles. they fit close to the face and are non-resistant to oil-based aerosols [ , , , ] . of note, most n respirators are not manufactured to be used in health care. prior to patient care, n respirators should be fit-tested and seal-checked. the wearer should meet facial hair requirements because n masks cannot be used when facial hair comes between the sealing surface of the facepiece and the wearer's face [ , , ] . the wearer of an n should be medically cleared to use a respirator because it could prove hazardous for people with certain breathing conditions [ ] . & powered air purifying respirators (paprs): certified by occupational safety and health administration, paprs are battery-powered respirators that use a blower to force filtered ambient air to the inlet covering [ ] . in contradistinction to n respirators, these are loose-fitting, provide eye protection, do not obscure the mouth, may be used with facial hair, and do not require a fit test. challenges when using a papr might include impeded hearing for the user because of the sound of the fan, pediatric patient apprehension, and decontamination after use [ , , ] . current guidelines do not require gowns to conform to specific standards [ ] .the choice of gown depends on the risk level for contamination [ ] . there should be enough fabric in the gown to wrap around the body and cover the back, even while sitting down or squatting [ ] . isolation gowns and surgical [ ] gowns, which are commonly used fluid-resistant and impermeable protective gowns, provide moderate to high barrier protection [ ] . surgical gowns should be prioritized for sterile procedures; disposable isolation gowns are sufficient for most patient encounters in pediatric radiology departments, even with high risk of contamination [ , ] . nonsterile disposable patient examination gloves are appropriate when caring for patients with suspected or confirmed covid- , similar to all contact precaution encounters [ ] . double gloves are not recommended for caring for covid- patients [ ] . standard precautions to minimize the spread of infection within health care facilities from direct contact with contaminations include hand hygiene, use of ppe based on anticipated contact with contaminated material, respiratory hygiene/ cough etiquette, cleaning and disinfection of the environment, and proper handling of patient care equipment and waste [ ] . the who and the cdc provide guidelines for transmissionbased precautions to be taken for patients with proven or suspected infection with certain pathogens [ , ] . transmission-based precautions are based on the mode of transmission of the pathogen and can be categorized as contact, droplet and airborne. these precautions are used for infections that can be transmitted through hand-to-hand contact and self-inoculation of nasal mucosa or conjunctiva [ ] . contact precaution measures include patient placement in a single room (if available), limiting the transport and movement of the patient outside the room only for medically necessary purposes, using disposable or dedicated patient-care equipment whenever possible, and frequent cleaning and disinfection of rooms. the appropriate ppe for contact precautions includes gloves and a gown, which must be worn for all interactions with the patient or the patient's environment. health care workers should wash their hands and don ppe before entering the room, and discard ppe before exiting and wash hands after doffing gloves. droplet precautions are used for patients who might be infected with pathogens transmitted via respiratory droplets. to control the source of pathogen spread, the infected patient should wear a surgical mask, be placed in a single room (if fig. proposed triage mechanism for resource allocation for aerosol-generating procedures (reprinted with permission from the society of interventional radiology). papr powered air purifying respirator, ppe personal protective equipment, pui person under investigation available), and instructed to follow respiratory hygiene and cough etiquette (e.g., covering mouth and nose with a tissue when coughing or sneezing, disposing the tissue in the nearest waste bin, and performing frequent hands hygiene). transport and movement of the patient must be limited to medically necessary purposes. as per cdc recommendations, upon entry into a patient room or space, the health care worker's eyes, nose and mouth should be covered with appropriate ppe, including a surgical mask and goggles. while recommendations regarding eye protection in the form of goggles or a face shield are still an "unresolved issue" as per the cdc, eye protection should be implemented during procedures and patient care activities that are likely to generate splashes or spray of body fluids or secretions [ ] . these precautions are appropriate for patients who might be infected with pathogens transmitted by an airborne route, including sars-cov , according to cdc guidelines. other examples of common airborne infections include tuberculosis, measles and chickenpox. the patient must wear a mask to control the source of infection. the best placement for the patient is an airborne infection isolation room, which is a negative-pressure room with dedicated exhaust. if an airborne infection isolation room is not available, the patient should be placed in a negative-pressure room without dedicated exhaust, or a private room with the doors closed. if transport is necessary, the patient must wear a surgical mask and follow respiratory hygiene and cough etiquette. for health care workers caring for these patients, the cdc recommends a fit-tested n or higher-level respirator as ppe. the cdc also recommends restricting susceptible health care personnel from entering the room of the patient, and immunizing susceptible people as soon as possible following unprotected contact (if a vaccine is available for the particular pathogen). appropriate personal protective equipment usage stratified by covid- status (table ) because of the possibility of airborne transmission of the virus, the cdc recommends respirators for care of all patients with covid- if adequate supplies are available. if respirators are not available, facemasks are a reasonable alternative. in contrast to the cdc guidelines, the who calls for airborne precautions only for aerosol-generating procedures. according to cdc guidance and general concepts of infection prevention, use of ppe in pediatric radiology departments should be determined by the principles underlying standard precautions (e.g., a basic risk assessment of the likelihood of contact with infectious material) and transmission-based precautions (e.g., routes of transmission of the proven or suspected pathogens). because contact with bodily secretions is expected during aerosolgenerating procedures, providers should at least wear a gown, gloves, a mask and eye protection. the conditions of the covid- pandemic demand judicious use of limited ppe supplies. to that end, patients can be stratified into five groups. the group raising highest concern among providers is those with positive reverse transcription polymerase chain reaction (rt-pcr) tests. a second, similar group consists of patients who have not been tested but are symptomatic, and have traveled to a high-risk area in the last days, or have had close contact with a person with covid- . the -day cut-off is based on the viral incubation period [ ] . this group should be presumed and treated as though covid- -positive, and testing may or may not be sent for these individuals. inpatient and emergency department settings might have the capacity for more widespread testing than outpatient environments, and might test mildly symptomatic or asymptomatic patients prior to an aerosol-generating procedure. once a covid- test has been sent, some consider this a third category, with the term "person under investigation" (pui) applied. turnaround time for these tests currently varies from min to a few days. therefore, patients with pending tests can be treated as presumed covid- positive until test results return [ ] . a fourth category is those who have been tested and whose rt-pcr test is negative. finally, the fifth category is those who are presumed covid- -negative, in whom suspicion of covid- is low and for whom no test is sent. depending on hospital workflow, patients might pass through several of these categories during the course of an encounter. providing n , eye protection, gloves and gowns to health care workers seeing all patients would be reasonable, but is not possible in most cases because of limitations on supplies [ ] . therefore, during this pandemic, ppe should be distributed where it will be most effective at preventing the spread of covid- . the highest risk of transmission arises during aerosol-generating procedures, especially those involving airway procedures or support. in the setting of limited ppe, respirators (n masks or paprs) should be reserved for these procedures, with papr used by those who cannot wear an n . all covid- -positive patients need these expanded precautions during aerosolizing procedures. for emergent cases, patients with pending tests or presumed positive patients need similar precautions to those with confirmed disease. for less urgent cases, it might be possible to wait for a covid- test to return. a more difficult question is how to approach aerosolizing procedures on patients who are either covid- -negative or who have not been tested. many practices require a covid- test be sent prior to performing an aerosol-generating procedure. a provider might want to consider the sensitivity of that test [ ] when deciding how heavily to rely on test results for categorizing risk [ , ] . for example, while many of the laboratory-developed tests have high analytical sensitivity (> - %), some automated platforms and point-of-care tests are less sensitive. clinical sensitivity of any test is difficult to confirm because there is no established gold standard. ultimately, if the provider is uncomfortable with the possibility of a false-negative test, then the provider should don airborne precaution ppe and perform the aerosol-generating procedure without waiting for test results. finally, for patients who test covid- -negative, standard ppe should be used. the cdc has published strategies for optimizing the supply of ppe and ventilators, and for managing surge capacity. three levels of surge capacity are described (table ) : conventional no change in normal daily practices; contingencymeasures may change daily standard practices, but may not have significant impact on patient care or health care provider safety; and crisisnot commensurate with u.s. standards of care. these measures, alone or in combination, may be necessary during periods of shortages [ , ] . extended use of ppe is a contingency capacity strategy in which the same ppe is used by one provider when interacting with more than one patient. for respirators, this strategy has been used during previous outbreaks for patients housed in the same location (cohorted). the maximum recommended extended use period is - h. reuse ("limited reuse") of ppe is a crisis capacity strategy in which the same ppe is used by one provider for multiple encounters with different patients, but is removed after each encounter or periodically. for respirators, a maximum of five uses per device is recommended. ppe should be discarded if it is grossly contaminated with patient bodily fluids or if it loses structural integrity. if possible, the cdc proposes a strategy where five respirators are issued to each provider who might be caring for covid- patients. the provider wears one per day, then stores the respirator in a breathable paper bag at the end of shift until the next week, allowing a minimum of five days between each use (the expected survival time of the sars-cov virus under these conditions is h). a number of other reprocessing or sterilization strategies have been proposed and have been validated to varying extents [ , ] . the increased demand for ppe and other medical devices has caused a breakdown in the supply chain. additive manufacturing ( -d printing) groups are addressing the resultant shortages. the first reported experience during the covid- pandemic was from an italian engineering team that re-created respirator parts [ ] . different sectors of the additive manufacturing industry have long shared their information through open-source file platforms, expanding their expertise into public and academic spaces, from forums like thingiverse [ ] to the national institute of health (nih) -d printing exchange [ ] . as an example, the -d printing team from the radiology department at children's hospital of philadelphia has partnered with supply chain management to produce or begin development of face shields and goggles, mask ear strap adaptors, papr hosing connectors, disposable exhalation ports, and reusable n respirators. on a local level, crowdsourced efforts might bring together additive manufacturing laboratories to share files, diversify machine styles and materials, collect limited raw materials, and ramp up productionsuch that a process that would usually take months, or even years, could be pared down to days or weeks. this could also reduce competition for raw materials in high demand, like thermoplastics and polymers. if distribution of these materials is also hampered by a supply chain breakdown, they could possibly be deemed non-essential and their production halted. in the near future, these efforts could be supported by industry partners with printing farms and large industrial machines. the speed of production in additive manufacturing is certainly an advantage, but it is essential to consider safety, both in quality control of the processes and in regulatory aspects of the products. a quality-control method entails documentation of manufacturing (e.g., confirming materials, printed files, and resolution) and use to ensure consistent output (e.g., inspecting and fixing burrs, delamination gaps, and cracks). it also establishes checkpoints for inspection and cleaning before each part enters the general supply. these methods are particularly important in efforts to solicit public donations. from a regulatory standpoint, now might be an opportune time to test the boundaries of approved applications like those in emergency use authorization [ ]. however, it must be done in a controlled fashion defined by specific conditions (e.g., the fda enforcement discretion policy [ ] ) to prevent a free-for-all beyond the scope of the situation. other considerations with additive manufacturing in this setting are: the limited supply of some of the necessary raw materials, such as clear polymers for face shields; and prioritizing design plans that result in products that can be cleaned and are durable enough for reuse. appropriate personal protective equipment usage specific to pediatric radiology (table , online supplementary material , pediatric radiology staff can be exposed to covid- while performing fluoroscopic or interventional procedures, scintigraphy or exams associated with anesthesia use. for these exams, there is increased risk from direct contact with body fluids, either in droplet or aerosolized form, to unprotected mucous membranes of the eyes, nose or mouth. at many institutions, all patients presenting for a radiology exam from the emergency department or as outpatients receive covid- tests. however, at the time of exam, test results from emergency department patients are often unavailable because test results can take up to days. despite the lack of evidencebased standards related to radiology procedures in the setting of covid- , many evolving practices are similar across the authors' institutions. lists of aerosol-generating procedures have been compiled by professional societies, but none is specific to pediatric radiology (fig. ) [ ] . standard aerosol-generating procedures remain undefined for many areas of practice, and the debate continues in the setting of the covid- pandemic. based on our collective experience, as well as recent guidelines published by the society of interventional radiology (sir) and society for nuclear medicine and molecular imaging (snmmi), common pediatric fluoroscopic, scintigraphic, and interventional procedures requiring ppe for airborne (aerosol) precautions are described in table . nasoenteric tube placements and exchanges are common for urgent or emergent fluoroscopic procedures performed in pediatric patients. both types are considered aerosol-generating because of the potential for sneeze or cough induction. upper gastrointestinal exams can also lead to aerosol formation in the setting of aspiration and cough. air enemas for intussusception reduction are typically considered aerosol-generating procedures, given their similarity to lower endoscopic procedures where the colon is insufflated and that they can lead to generation of aerosols containing fecal material while gas is evacuated [ ] . some argue that liquid contrast agent might be safer for intussusception reductions because it might decrease risk of aerosolization compared with droplets. however, given that luminal pressure is still elevated in combination with increased intraabdominal pressure, and that there is evidence that viral shedding in stool may be found weeks after resolution of fever in covid- -positive patients [ ] , many think that aerosolization remains a risk in all intussusception reductions, regardless of contrast agent, because of the risk of spraying fecal material. discussions about aerosol-generating procedure risk between air-and liquid-contrast intussusception reductions should also incorporate safety profiles, which tend to favor air reductions because of their comparable success rate with lower radiation [ , ] . for all aerosol-generating procedures in children who have either unknown or confirmed positive covid- status, radiologists should adhere to the highest level of respiratory protection available: a respirator, an eye shield, a disposable gown and gloves. additional measures to augment safety might include requiring the child to also wear a mask. only essential personnel should be present in the fluoroscopy suite during the procedure. if the covid- test is negative, appropriate ppe for the specific patient encounter should be used for aerosol-generating fluoroscopy exams, which might include precautions against viral droplets or spray of bodily fluids (following cdc standard precautions philosophy) [ ] . pediatric interventional radiology procedures are often performed under sedation or anesthesia. accordingly, all such procedures are considered aerosol-generating because of airway manipulation from intubation and airway rescue or suctioning during the exam. many institutions, such as seattle children's hospital, require all patients undergoing anesthesia or sedation to have a covid- test performed within h prior to the procedure. for patients with positive covid- test results, the highest level of respiratory protection is required for all health care workers involved throughout the duration of the procedure. for sterile procedures, scrubbed personnel close to the sterile field should use papr shrouds to prevent air blown into the sterile field. in nuclear medicine, ventilation scans use xenon- or, l e s s c o m m o n l y , a e r o s o l i z e d t e c h n e t i u m - mdiethylenetriamine pentaacetate (tc- m-dtpa). if a ventilation/perfusion (v/q) scan is requested, aerosolgenerating procedure risk can be mitigated by performing perfusion only [ ] . scintigraphic gastric emptying, esophageal reflux, and salivary gland exams can also induce vomiting or coughing in children, and therefore aerosol-generating procedure precautions might be taken. because of the length of time required for many scintigraphic exams, patients should wear a mask if possible. because of the broad net cast by the sir in classifying sedated procedures as aerosol-generating procedures [ ] , further clarifications are warranted regarding the true risks of airborne transmission in what would inherently be a nonaerosol-generating procedure. for example, one might reasonably question whether a sedated voiding cystourethrogram in a child with unknown covid- status should necessitate airborne ppe precautions because of the low risk of airway rescue. while the authors think that many such procedures are not necessarily aerosol-generating procedures because of the low risk of additional airway manipulation and subsequent aerosolization, evidence to support or dispute this rationale has not been established. such nonurgent examinations are uncommon during this pandemic, but speak to the need to establish clear guidelines around aerosol-generating procedures as outpatient imaging volumes return to normal levels. for all children undergoing examinations in the radiology department, ppe usage by patients should be consistent with the appropriate level of transmission precautions required for their care, following cdc standard precautions [ ] . all patients should wear masks and follow basic respiratory hygiene and cough etiquette principles if possible, if they are symptomatic for a viral upper respiratory infection [ ] . wearing a mask might not be possible for children undergoing an aerosol-generating procedure that requires access to nose or mouth (e.g., upper gastrointestinal series or nasogastric tube placement), for infants and young children, or for cognitively impaired children. the accompanying caregiver may be encouraged or required to wear a mask, even when asymptomatic, depending on the particular hospital's policies. symptomatic caregivers should be asked to leave and find an asymptomatic caregiver to accompany the child whenever possible. limiting the number of caregivers in these encounters minimizes the possibility of exposure between an asymptomatic adult carrier of the virus and health care provider. risk of exposure is particularly high for technologists, who perform a wide variety of radiology exams across the department and have direct contact with patients. consequently, radiologists should be sensitive to and supportive of their technologists' workflow. technologists should wear the highest level of protection when interacting with emergency department patients who are symptomatic for viral infection, regardless of a verified covid- status. for patients who are asymptomatic, technologists should take respiratory (droplet) precautions (mask and face shield), with or without additional contact precautions (gown and gloves). technologists also have more interaction with other health care staff while performing portable exams or receiving patient care teams at the scanner. it is important that the ppe worn by radiology technologists is similar to that worn in the patient care environment, with increased protection as necessary depending on the technologist's task. similarly, other critical support staff in the radiology department, such as nurses, should adhere to ppe precautions commensurate with each encounter because of their close contact with patients. of note, the presence of child life specialists to optimize chances for a successful study should be balanced with the need to minimize exposure between staff and patient. the ppe available to radiology staff might be limited by hospital supply chains. radiologists should advocate for safe ppe for department personnel, as those distributing hospital ppe might have a limited understanding of the varied roles technologists have. finally, we return to the initial question posed regarding appropriate ppe usage for the pediatric radiologist about to perform an aerosol-generating procedure on a child with unknown covid- status. a conservative approach, and one that is backed by current cdc guidelines, would recommend that radiologist don airborne and contact transmission precautions, which include a respirator if available, eye protection, gown and gloves. however, droplet and contact precautions eye protection, surgical mask, gown and glovesmight be a reasonable alternative depending on ppe availability. health care providers are faced with an overwhelming amount of data and constantly evolving recommendations regarding the covid- pandemic. it can be challenging to remain current with evolving guidelines while also providing optimal patient care and fulfilling other professional obligations. first and foremost, each radiology department should align with institutional guidelines regarding infection control. current versions of these materials should be distributed to all radiology personnel. the cdc is also actively adapting ppe recommendations as the situation evolves [ ] . professional societies, including the american academy of pediatrics and the society for healthcare epidemiology of america, refer directly to the cdc for guidance on the recommended use of ppe. health care organizations with early experience in managing covid- patients have also developed extensive policies and protocols, including ppe recommendations, which are available for review. additional resources and clinical guidelines are provided by the university of washington medicine covid- resource site [ ] and the brigham and women's hospital [ ] . the covid- pandemic has presented an array of unique and daunting challenges, not the least of which is maintaining the safety of health care providers while they care for patients. although respiratory droplet transmission of the virus is most likely, our current understanding indicates health care providers should nonetheless don a respirator, if available, whenever caring for a covid- -positive patient. in pediatric radiology departments, this is particularly true for aerosolgenerating procedures that might result in cough or spray of fecal matter, such as intussusception reductions. this precaution also applies to procedures involving intubated and sedated children. fundamental knowledge of ppe and infectious transmission is crucial for pediatric radiologists as we navigate through this pandemic and enter a world of heightened awareness of infection control. covid- epidemic: disease characteristics in children epidemiology, virology, and clinical 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resource site hospital ( ) brigham and women's hospital covid- clinical guidelines publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations acknowledgments the authors wish to thank lydia sheldon for her editorial contributions to this manuscript. key: cord- -wka q s authors: vong, sirenda; samuel, reuben; gould, philip; el sakka, hammam; rana, bardan j; pinyowiwat, vason; bezbaruah, supriya; ofrin, roderico title: assessment of ebola virus disease preparedness in the who south-east asia region date: - - journal: bull world health organ doi: . /blt. . sha: doc_id: cord_uid: wka q s objective: to conduct assessments of ebola virus disease preparedness in countries of the world health organization (who) south-east asia region. methods: nine of countries in the region agreed to be assessed. during february to november a joint team from who and ministries of health conducted – day missions to bangladesh, bhutan, indonesia, maldives, myanmar, nepal, sri lanka, thailand and timor-leste. we collected information through guided discussions with senior technical leaders and visits to hospitals, laboratories and airports. we assessed each country’s ebola virus disease preparedness on tasks under nine key components adapted from the who ebola preparedness checklist of january . findings: political commitment to ebola preparedness was high in all countries. planning was most advanced for components that had been previously planned or tested for influenza pandemics: multilevel and multisectoral coordination; multidisciplinary rapid response teams; public communication and social mobilization; drills in international airports; and training on personal protective equipment. major vulnerabilities included inadequate risk assessment and risk communication; gaps in data management and analysis for event surveillance; and limited capacity in molecular diagnostic techniques. many countries had limited planning for a surge of ebola cases. other tasks needing improvement included: advice to inbound travellers; adequate isolation rooms; appropriate infection control practices; triage systems in hospitals; laboratory diagnostic capacity; contact tracing; and danger pay to staff to ensure continuity of care. conclusion: joint assessment and feedback about the functionality of ebola virus preparedness systems help countries strengthen their core capacities to meet the international health regulations. the - ebola virus disease epidemic in west africa was the largest ever reported, with cases and deaths as of june . in august , the world health organization (who) declared the epidemic a public health emergency of international concern, in accordance with the international health regulations (ihr). in january , nine of the countries from the who south-east asia region agreed to a joint assessment by who and ministries of health of their preparedness and operational readiness for ebola virus disease. the framework for the assessment were the key components and tasks proposed as indicators in the who consolidated ebola preparedness checklist issued in january . as the likelihood of ebola virus disease introduction in the region was considered low, we focused mainly on minimum preparedness requirements and adapted the tasks according to the regional context. this report summarizes the findings of the country reviews in bangladesh, bhutan, indonesia, maldives, myanmar, nepal, sri lanka, thailand and timor-leste. during february to november a series of - day missions were undertaken to each country by a joint assessment team comprising staff from who and the respective ministry of health (and in thailand the united states centers for disease control and prevention as invited partners). information was collected through guided discussions ( or days) with key ministry of health technical leaders (i.e. those responsible for ministry departments or divisions, and unit, branch or team leaders). the guided discussion technique aimed to elicit dialogue and exchanges between the assessors and participants, to review procedures and interdepartmental interactions and to analyse the functionality of the health emergency systems. discussions continued with technical leaders during visits to specific settings: the country's major international airport and its ebola virus disease reference hospital and reference laboratory ( day). we dedicated a half day to train the joint assessment team members and another half day to present preliminary findings to the same audience for clarification and to reach consensus ( day). the final results and recommendations were summarized in the form of a report and presented to the health authorities of the country on the last day of the visit ( day). who committed to monitoring the implementation of the recommendations. we designed a checklist to review each country's preparedness activities and procedures on nine key components: a. emergency planning; b. risk assessment; c. leadership and coordination; d. surveillance and early warning; e. laboratory diagnosis; f. rapid investigation and containment; g. infection control and clinical management; h. communication; and i. points of entry. each assessment component comprised several objective to conduct assessments of ebola virus disease preparedness in countries of the world health organization (who) south-east asia region. methods nine of countries in the region agreed to be assessed. during february to november a joint team from who and ministries of health conducted - day missions to bangladesh, bhutan, indonesia, maldives, myanmar, nepal, sri lanka, thailand and timor-leste. we collected information through guided discussions with senior technical leaders and visits to hospitals, laboratories and airports. we assessed each country's ebola virus disease preparedness on tasks under nine key components adapted from the who ebola preparedness checklist of january . findings political commitment to ebola preparedness was high in all countries. planning was most advanced for components that had been previously planned or tested for influenza pandemics: multilevel and multisectoral coordination; multidisciplinary rapid response teams; public communication and social mobilization; drills in international airports; and training on personal protective equipment. major vulnerabilities included inadequate risk assessment and risk communication; gaps in data management and analysis for event surveillance; and limited capacity in molecular diagnostic techniques. many countries had limited planning for a surge of ebola cases. other tasks needing improvement included: advice to inbound travellers; adequate isolation rooms; appropriate infection control practices; triage systems in hospitals; laboratory diagnostic capacity; contact tracing; and danger pay to staff to ensure continuity of care. conclusion joint assessment and feedback about the functionality of ebola virus preparedness systems help countries strengthen their core capacities to meet the international health regulations. functionality of tasks was scored as follows: no structure in place or activities not addressed (score ); activities planned but not implemented (score ); activities in place but low evidence of functionality (score ); or complete response, i.e. evidence of fully functional activities and readiness or planning for surge capacity (score ). (. . .continued) tasks or activities (total ) ( table ) . each task addressed one of the three aspects of preparedness: what activities are currently operational for handling the threat of ebola virus disease (currently functional activities); how prepared the country is for the introduction of an ebola virus disease case (operational readiness); and how prepared the country is to face a wider outbreak of ebola virus (surge capacity; table ). core questions were prepared to trigger guided discussion and contextual questions about the tasks (available from the corresponding author). to standardize analysis across countries and facilitate discussion between the joint assessment team members we scored the functionality of each task from to : no structure in place or activities not addressed (score ); activities planned but not implemented (score ); activities in place but with low evidence of functionality (score ); or complete response, i.e. evidence of fully functional activities and readiness or planning for surge capacity (score ; table ). readiness of a structure that was already in place was assessed on the level of training as follows: low evidence of functionality, when simple training such as a lecture or demonstration was carried out (score ); or high evidence of functionality, if simulations were conducted regularly and reported to be followed by improvements (score ). high surge capacity was defined as evidence of surge planning in terms of sufficient enrolment of trained staff and adequate space and supplies. our assessments were based on documented evidence or participants' descriptions of procedures. the who ethical research committee reviewed the programme methods and concluded that the activity did not qualify as research with human subjects. all nine countries had some level of preparedness for ebola virus disease (fig. ) . however, only seven of the countries had developed a specific, written ebola virus disease preparedness plan (task a ), including four that had detailed a risk-based approach and some level of linkage with their pandemic influenza preparedness plans. only five of them had costed and budgeted the plan. six countries had disseminated the plan, generally via the ministry of health website (bangladesh, bhutan, indonesia, maldives, sri lanka and thailand). all countries reported having a mechanism for releasing funds for a potential ebola virus disease importation or outbreak (task a ), including eight whose mechanism relied on a legislative framework that was not necessarily associated with disaster situations. however, five countries expressed difficulties in releasing funds dedicated to preparedness activities, two of which struggled with major bottlenecks in funding and had asked who for financial support. only bhutan, maldives and thailand had introduced a bonus system or hazard pay for health and non-health professionals in high-risk assignments, or compensation in case of infection or death (task a ). others countries had it only for health-care professionals or had some sort of compensation based on promotion or choice of transfer. bangladesh and nepal reported no special plan for staff motivation or compensation for high-risk assignments. risk assessment is a core capacity requirement of the ihr. it provides objective information needed for decision-making and adequate risk-based preparedness and response. our review showed that risk assessment (i.e. evaluating the likelihood of ebola virus disease being imported or introduced into a non-affected country) had been formally or informally conducted in six countries (bhutan, indonesia, maldives, sri lanka, thailand and timor-leste). of these, most had conducted a risk assessment only once at the early phase of preparedness, rather than as a continuous evaluation, and most relied on the results of the regular who global risk assessments in which country-specific recommendations are limited. only sri lanka and thailand used risk assessment for preparedness by identifying several scenarios of ebola virus disease to be addressed in the preparedness process. at the time of our review, no reports of such risk assessment were documented and none of the countries had developed formal risk assessment procedures or a manual (task b ). high level authorities of all countries were committed to ebola virus disease preparedness planning. coordination mechanisms and systems relied on existing structures (a committee or task force) that had been developed during the avian influenza pandemic threats (e.g. a/h n , a/h n ) or the a/h n influenza pandemic. all of these committees were multisectoral and multilevel and led by high-level health authorities (task c ). usually a technical subcommittee had been set up to develop and implement the ebola virus disease plan, backed by a multidisciplinary expert committee (task c ). the incident management structure, with roles and responsibilities defined, were detailed in the ebola virus disease preparedness plans (task c ). indonesia, myanmar and sri lanka had encouraged committees at the subnational level to develop preparedness plans. countries had different understandings of the functions of an emergency operating centre, such as where a centre should be located and whether they needed several centres or one comprehensive emergency operating centre encompassing all types of response. also, the potential to use such a centre as a centre for data management and analysis was often overlooked. while many epidemiology and surveillance departments did not have a functional emergency operating centre or a definite location for it at the time of the review, all ministries of health had such a centre handled by the ministry's disaster management department (task c ). among the reviewed countries, sri lanka and thailand fully satisfied the effectiveness criteria of an early warning system (task d ) and capacity to identify potential incubating travellers (i.e. travellers who had visited ebolaaffected countries) for medical followup (task i ). most countries use an internetbased system to report diseases. bangladesh, myanmar, nepal and timor-leste had no national system of immediate reporting (e.g. legally binding system of notifiable diseases). others relied solely on sentinel public hospitals and tally sheets to report cases in an aggregated manner. indonesia and nepal reported insufficient focus on raising awareness about ebola virus disease among clinicians from the private and public sectors (task d ). in general, a country's surveillance/ epidemiology unit should coordinate the -day follow-up of at-risk travellers returning from affected countries from the list provided by airport health offices. the system was in place in all countries and appeared functional in most. event-based surveillance was acknowledged by all countries to be efficient for detecting clusters of unknown events in the community or hospitals (task d and d ). with respect to laboratory preparedness, all countries had at least one national reference laboratory. bangladesh, indonesia, nepal and thailand possessed a biosafety level facility; however, only two of these (in indonesia and thailand) were actually functional at the time of our visit. nevertheless, all these laboratories had, or could upgrade rapidly to, biosafety level + capacity if necessary (i.e. a minimum capacity that could permit inactivation of specimens and where laboratory technicians are well trained in use of personal protective equipment; task e ). while the smaller countries (bhutan, maldives and timor-leste) did not have virologists with higher degree qualifications, all countries had laboratory technicians skilled in polymerase chain reaction (pcr) testing methods, who could process samples in biosafety level + conditions; this was a direct result of the development of national influenza surveillance centres (task e ). only bangladesh, indonesia and thailand had developed a molecular technique for ebola virus disease diagnosis; all three had identified suspected ebola virus disease cases in the past year. others had stand-by arrangements with a courier company to transport specimens, and expected to rely on the who regional office for south-east asia to assist in directing the specimens to a suitable reference laboratory (task e ). all countries had integrated the concept of rapid response teams into their response to a public health event. all had such teams at the central and subnation-al level and were using a multisectoral and multidisciplinary approach (task f ). some countries conducted extensive training or simulations regarding an ebola virus disease outbreak, followed by refresher courses; the primary trainings were on personal protective equipment and information about ebola virus disease. some countries (bhutan, sri lanka and thailand) had developed a more cost-effective approach, which involved extensive training and simulations at the central level and only providing instructions to the subnational level. training would be rolled out to the subnational rapid response teams should the risk of introduction or spread of ebola virus increase (tasks f - ). smaller countries (bhutan, maldives and timor-leste) reported issues related to insufficient skills among rapid response team staff, and a high turnover of staff, which meant that refresher courses needed to be conducted more frequently. all countries had designated at least one national reference hospital for management of patients with ebola virus disease; all but one had evidence that ebola disease information was disseminated as part of educational activities among health and non-health hospital staff. indonesia, sri lanka and thailand conducted training extensively within the hospital or in many designated hospitals using a cascade training approach or mobile training teams (task g ). our review found that only indonesia, maldives, sri lanka and thailand showed evidence of operational readiness to isolate and manage a suspected or confirmed ebola virus disease case (i.e. had suitable isolation rooms ready to accommodate and treat patients; staff trained in ebola virus disease response; appropriate supplies; and systems for management of clinical and human waste). of these, one country recognized that it would face difficulties if several cases were to be isolated or if contacts needed to be quarantined (task g ). many of the visited hospitals had primarily developed a system for separating referred suspected ebola virus disease patients from other patients. triage procedures for use by health-care personnel for suspected walk-in patients at an emergency department were poorly planned or adopted. comprehensive exercises had been conducted in the visited hospitals in five countries (bhutan, indonesia, maldives, sri lanka and thailand; task g ). all but two countries acknowledged having limited clinical expertise for managing an ebola virus disease case; participants reported that most infectious disease physicians had selftrained using who and other international institutions' clinical management guidelines, and few of them had been to the regional training on ebola clinical management held in bangkok, thailand in march . all but one country had prepared a telephone hotline support system connecting health-care providers with a team of clinicians with expert knowledge (task g ). capacity for raising public awareness and social mobilization about ebola virus disease was high across the countries. thanks to high internet coverage, countries could easily disseminate information and who guidelines about ebola virus disease to the subnational level. most countries acknowledged gaps in risk communication and requested support for further strengthening of this. all countries reported having functioning communication coordination mechanisms involving all government sectors and other stakeholders and these had been strengthened and tested during the avian influenza threats and the recent pandemic influenza periods. our visits to international airports in each country found a high level of awareness about the threat posed by the possible arrival of ebola-infected patients. who has recommended that airport staff should identify international travellers exhibiting signs and symptoms of ebola virus disease, or with a history of exposure to ebola virus, and provide a coordinated response on arrival. while some airports were not up to standard or poorly equipped (e.g. without an isolation or holding-area facility), there was close collaboration between the airport authorities and the health authorities in all countries. mechanisms for sharing information about at-risk travellers between the surveillance department and the health offices at airports were in place and appeared to be functional (task i ). specific emergency plans for importation of ebola virus disease or middle east respiratory syndrome ebola virus disease preparedness sirenda vong et al. (mers) coronavirus were tested by undertaking drills that encompassed detection of a suspected ebola virus disease case and transfer from the airport to the reference hospital (with whom stand-by arrangements had been made beforehand) (task i ). communication to travellers is paramount so that any at-risk travellers can report to the health authorities for medical screening and a -day followup. nevertheless, we felt that in some airports in bhutan, indonesia, maldives and nepal, the authorities had recently lowered their guard on communication and advice to travellers, probably due to ebola preparedness fatigue. this situation may increase the risk of a traveller with incubating ebola virus entering the country and not reporting voluntarily (particularly those travelling from a non-affected third country; task i ). all of the countries that we reviewed have committed to ebola virus disease preparedness and response planning. preparedness was most advanced on the following key components: multilevel and multisectoral collaboration and coordination structures; multidisciplinary rapid response teams at the central level; capacity for public communication and social mobilization; some level of preparedness in international airports; training on personal protective equipment; and laboratories with molecular diagnostic capacity. planning was triggered in all countries after who declared ebola virus disease as a public health emergency of international concern in . the ebola preparedness plans tended to rely on generic structures previously established for influenza pandemics in the countries. effectiveness in implementing ebola virus disease preparedness can therefore be interpreted as a return on investment in ihr capacities. this underscores the fundamental importance of the ihr mechanism for global health security. our study provides not only an indication of ebola disease preparedness but also a measure of countries' progress towards meeting ihr core capacity requirements. by the end of only thailand and indonesia have reported to who that they have met ihr require-ments in . several improvements are needed if all countries in the who south-east asia region are to comply with the ihr. first, efforts are needed to strengthen risk assessment capacity across the region. risk assessment, when conducted, was limited in scope in most countries, because processes, risk questions and recommendations were unclear or not made available. there was a limited use of risk assessment, with its potential to evaluate system vulnerabilities in a transparent way and to identify process and knowledge gaps. , second, the risk communication capacity of countries was also weak: unsurprisingly, as this is closely linked with risk assessment. [ ] [ ] [ ] most countries had deficiencies in this area, and recognized difficulties in developing their risk communication strategic and action plan. third, preparedness efforts to ensure continuity of care for potential ebola cases, which include danger pay for staff, were not optimal in many of the countries. most participants in the discussions felt that keeping health-care staff on the job if an ebola case were suspected would be a challenge. only indonesia and thailand had experience in handling a highly contagious disease (e.g. h n influenza virus infection since ). fourth, while all the countries possessed indicator-based and event-based surveillance, as required by the ihr, , most acknowledged that a timely and sensitive early warning system was difficult to achieve. this was due to several factors: slow collection of data from a limited number of sites; no case-based, immediate reporting mechanism; and limited capacity to process and analyse data. further investments in automated surveillance that rapidly collects and analyses large amounts of data may be needed. fifth, most countries had not attempted to introduce molecular techniques for ebola virus disease diagnosis, even though they had pcr testing capacity for other viruses (e.g. merscoronavirus or influenza viruses) and had laboratory capacity at the minimum biosecurity level for ebola virus inactivation (biosafety level + or ). in some of these countries, experience with a handful of suspected patients (later found to be negative) showed that patients' pcr results took - days to be returned from reference laboratories in other countries. this delay highlights a need for in-country capacity for ebola virus disease diagnosis, supported by stand-by arrangements with global who collaborating centres. other challenges that needed improvement in the countries included several elements that were prominent in the - west african ebola virus disease epidemic: advice to inbound travellers; adequate isolation rooms; appropriate infection control practices; emergency department triage systems in general hospitals; contact tracing; and danger pay to health-care workers to ensure continuity of care. staff fears about ebola virus contagion are important to address, as even the best plans can fail if there is absenteeism and disruptions in supporting services and supplies. finally, in some countries, particularly the smaller ones, substantial shortfalls in preparedness were revealed concerning: accommodating a surge of cases in health-care facilities; testing for multiple cases and contacts; and mobilizing staff for contact tracing. countries need to be prepared for a scenario that rapidly overwhelms the capacity of health authorities. they should therefore consider detailed surge capacity planning that includes stand-by arrangements with other ministries (e.g. defence or interior) and civil society or international partners. our findings have some limitations. first, the results are just a snapshot of each country's situation: a status that is dynamic and can improve or deteriorate. second, findings were based on a broad review of procedures rather than a quality analysis of the documents or direct observations of performance. an overall high level of readiness should be interpreted as indicating that the country is taking steps to ensure that its plan is truly operational and that the planned activities are actionable. third, our assessment indicators were adapted from the who ebola preparedness checklist, but, due to time constraints, have not been formally piloted. the choice of indicators and the scoring system can be debated. for example, due to time research ebola virus disease preparedness sirenda vong et al. constraints we chose not to study preparedness on specific logistics of ebola virus disease from the who checklist. instead we focused on the main pillars of the ihr. rather than evaluating and comparing countries, our joint who and health ministry approach aimed to help countries to prioritize and formally document their most urgent needs to enhance preparedness and response within their health security system. we appreciate that sri lanka has made the report publicly available, which is one of the goals of the review. we hope that other countries are encouraged to use a similar transparent and constructive process whereby who and national participants work together in interactive sessions to reach a consensus with clear justifications. transparency and consensus were adopted by who's joint external evaluation in to monitor ihr compliance and help attract and direct resources to where they are needed most. this study has provided a general picture of comparative strengths and weaknesses across various aspects of ebola disease preparedness that are also key components of the ihr core capacity requirements. further strengthening of ihr capacities must involve testing the functionality of preparedness and response systems. an ihr monitoring and evaluation mechanism is needed that incorporates joint assessment processes, repeated simulation exercises and risk assessment processes that look into system vulnerabilities. many countries have a limited ability to address every type of hazard or large-scale event. ihr-related planning should therefore include detailed stand-by arrangements between countries and with who on areas of vulnerability. ■ осуществлении контроля над событием, а также было выявлено, что применение молекулярных технологий диагностики недостаточно развито. Во многих странах планирование действий в случае вспышки лихорадки Эбола было ограниченным. К числу других задач, требующих улучшения, относятся следующие: рекомендации для лиц, перемещающихся внутри страны, достаточно оснащенные изоляторы, соответствующие практики ограничения распространения инфекции, системы сортировки пациентов в больницах, наращивание возможностей лабораторной диагностики, отслеживание контактов и дополнительная оплата работникам за риск для обеспечения непрерывного ухода за больными. Вывод Совместная оценка и отзывы относительно функционирования сис тем готовнос ти к вирусной лихорадке Эбола помогают странам укрепить ключевые возможности, необходимые для соблюдения международных медико-санитарных правил. evaluación de la preparación ante el virus del Ébola en la región del sudeste asiático de la oms objetivo llevar a cabo evaluaciones de la preparación ante el virus del Ébola en países de la región del sudeste asiático de la organización mundial de la salud (oms). métodos nueve de once países de la región aceptaron ser evaluados. de febrero a noviembre de , un equipo conjunto de la oms y los ministerios de sanidad llevaron a cabo misiones de entre y días en bangladesh, bután, indonesia, maldivas, myanmar, nepal, sri lanka, tailandia y timor-leste. se recopiló información a través de conversaciones dirigidas con jefes técnicos y visitas a hospitales, laboratorios y aeropuertos. se evaluó la preparación ante el virus del Ébola de cada país en tareas con componentes clave adaptados de la lista de preparación ante el ébola de la oms de enero de . resultados el compromiso político para la preparación ante el ébola era elevado en todos los países. la planificación era más avanzada para los componentes que habían sido previamente planificados o probados para pandemias de gripe: coordinación de varios niveles y sectores, equipos de respuesta rápida multidisciplinares, comunicación pública y movilización social, simulacros en aeropuertos internacionales y formación sobre equipos de protección individual. entre las principales vulnerabilidades se encontraba una evaluación de riesgos y comunicación de riesgos poco adecuadas, lagunas en la gestión y el análisis de datos para el control de acontecimientos y una capacidad limitada en técnicas de diagnóstico molecular. muchos países tenían una planificación limitada en caso de que resurgieran casos de ébola. entre otras tareas que necesitaban mejorar se encontraban: asesoría a viajeros entrantes, salas de aislamiento adecuadas, prácticas de control de infecciones adecuadas, sistemas de clasificación en hospitales, capacidad de diagnóstico en laboratorios, localización de contactos y prima de peligrosidad para el personal para garantizar la continuidad de la atención. conclusión la evaluación conjunta y los comentarios sobre la funcionalidad de los sistemas de preparación ante el virus del Ébola ayudan a los países a fortalecer sus capacidades principales para cumplir el reglamento sanitario internacional. geneva: world health organization geneva: world health organization world health organization eugene: lane community college developing the science of health care emergency preparedness and response ebola event management at points of entry. interim guidance. geneva: world health organization pandemic influenza preparedness plan. who guidance document. geneva: world health organization pandemic influenza risk management. who interim guidance. geneva: world health organization rapid risk assessment methodology. ecdc technical document. stockholm: european centre for disease control rapid risk assessment of acute public health events. geneva: world health organization geneva: world health organization risk communication-the link between risk assessment and action-poster corner european food safety authority scientific committee ihr core capacity monitoring framework: checklist and indicators for monitoring progress in the development of ihr core capacities in states parties. geneva: world health organization ebola virus disease preparedness sirenda vong et al new delhi: world health organization regional offices for south-east asia and western pacific automated detection and reporting of notifiable diseases using electronic medical records versus passive surveillance-massachusetts laboratory diagnosis of ebola virus disease. interim guideline new delhi: world health organization regional office for south-east asia joint external evaluation tool: international health regulations we thank country-specific partners and who staff in all participating sites: key: cord- - db gwhk authors: vento, sandro; cainelli, francesca; vallone, alfredo title: violence against healthcare workers: a worldwide phenomenon with serious consequences date: - - journal: front public health doi: . /fpubh. . sha: doc_id: cord_uid: db gwhk nan verbal and physical violence against healthcare workers (hcws) have reached considerable levels worldwide, and the world medical association has most recently defined violence against health personnel "an international emergency that undermines the very foundations of health systems and impacts critically on patient's health" ( ) . two systematic reviews and meta-analyses published at the end of found a high prevalence of workplace violence by patients and visitors against nurses and physicians ( ) , and show that occupational violence against hcws in dental healthcare centers is not uncommon ( ) . in the first study ( ) , the authors systematically searched pubmed, embase, and web of science from their inception to october , and included eligible studies (with a total of , participants). . % of the participants reported exposure to any form of workplace violence, . % reported exposure to non-physical violence, and . % experienced physical violence in the past year. verbal abuse ( . %) was the most common form of non-physical violence, followed by threats ( . %) and sexual harassment ( . %). the prevalence of violence against hcws was particularly high in asian and north american countries, in psychiatric and emergency departments, and among nurses and physicians ( ) . in the second study ( ), a systematic review and analysis of the literature was done using pubmed, sciencedirect, scopus, web of science, cochrane library and proquest. original articles published between january and august and written in english were included in the analysis. the violence experienced by dental healthcare workers was both physical and nonphysical (shouting, bullying, and threatening) and also included sexual harassment ( ) , and in most cases, male patients, or coworkers were responsible. violent events ranged from . to . % with a mean prevalence of %, and physical abuse ranged from . to % ( ). most recently, the world medical association has condemned the increasingly reported cases of health care workers being attacked because of the fear that they will spread sars-cov- . the situation in india is particularly shocking, with health care workers stigmatized, ostracized, discriminated against, and physically attacked, but incidents have been reported across the world, for instance from france, mexico, philippines, turkey, uk, australia, and usa ( , ) . the recent systematic reviews and meta-analyses and the world health organization condemnation of the attacks against hcws treating patients with covid- have confirmed the seriousness of the situation regarding violence against doctors and nurses worldwide. many countries have reported cases of violence, and some are particularly affected by this problem. a chinese hospital association survey collecting data from hospitals revealed that % of the hospitals surveyed experienced workplace violence in ( ) , and a study done by the chinese medical doctor association in showed that over % of physicians ever experienced verbal abuse or physical injuries at work ( ) . an examination of all legal cases on violence against health professionals and facilities from the criminal ligation records - , released by the supreme court of china, found that beating, pushing, verbal abuse, threatening, blocking hospital gates, and doors, smashing hospital property were frequently reported types of violence ( ) . in india, violence against healthcare workers and damage to healthcare facilities has become a debated issue at various levels ( ) , and the government has made violence against hcws an offense punishable by up to years imprisonment, after various episodes of violence and harassment of hcws involved in covid- care or contact tracing ( ) . in germany, severe aggression or violence has been experienced by % of primary care physicians ( ) . in spain, there has been an increase in the magnitude of the phenomenon in recent years ( ) . in the uk, a health service journal and unison research found that nhs trusts in england reported , physical assaults on staff in - ( ) . in the usa, - % of workplace assaults occur in healthcare settings ( ) . in italy, in just one year, % of nurses were verbally assaulted in the workplace, % experienced physical violence, % were threatened with a weapon ( ); % of physicians were verbally, and % physically, assaulted ( ) . in poland, czech republic, slovakia, turkey many nurses have been physically attacked or verbally abused in the workplace ( ) . according to the south african medical association, over hospitals across south africa reported serious security incidents in just months in ( ) , and in cape town violence against ambulance crews is widespread ( ) . in iran, the prevalence of physical or verbal workplace violence against emergency medical services personnel is and % respectively ( ) . the world health organization lists australia, brazil, bulgaria, lebanon, mozambique, portugal, thailand as other countries where studies on violence directed at hcws have been conducted ( ) . the consequences of violence against hcws can be very serious: deaths or life-threatening injuries ( ) , reduced work interest, job dissatisfaction, decreased retention, more leave days, impaired work functioning ( ) , depression, post-traumatic stress disorder ( ), decline of ethical values, increased practice of defensive medicine ( ) . workplace violence is associated directly with higher incidence of burnout, lower patient safety, and more adverse events ( ) . which are the most at-risk services and what are the underlying factors of this growing violence? emergency departments, mental health units, drug and alcohol clinics, ambulance services and remote health posts with insufficient security and a single hcw are at higher risk. working in remote health care areas, understaffing, emotional or mental stress of patients or visitors, insufficient security, and lack of preventative measures have been identified as underlying factors of violence against physicians in a systematic review and meta-analysis ( ) . in public hospital/services, insufficient time devoted to patients and therefore insufficient communication between hcws and patients, long waiting times, and overcrowding in waiting areas ( ) , lack of trust in hcws or in the healthcare system, dissatisfaction with treatment or care provided ( ), degree of staff professionalism, unacceptable comments of staff members, and unrealistic expectations of patients and families over treatment success ( ) are thought to contribute. indeed, in public hospitals worldwide, staff shortages prevent front-line hcws from adequately coping with patients' demands. in private hospitals/services, too extended hospital stays, unexpectedly high bills, prescription of expensive and unnecessary investigations are key factors. finally, the media frequently report extreme cases of possible malpractice and portray them as representative of "normal" practice in hospitals ( ) . what can be done to reduce the escalating violence against hcws? hcws worldwide generally advocate for more severe laws, but harsher penalties alone are unlikely to solve the problem. importantly, evidence on the efficacy of interventions to prevent aggression against doctors is lacking, and a systematic review and meta-analysis found that only few studies have provided such evidence ( ) . just one randomized controlled trial indicated that a violence prevention program decreased the risks of patient-to-worker violence and of related injury in hospitals ( ) , whereas contrasting results in violence rates after implementation of workplace violence prevention programs have been observed from longitudinal studies ( ) . there is no evidence on the effectiveness of good place design and work policies aimed to reduce long waiting times or crowding in waiting areas ( ) . more studies are clearly needed to provide evidence-based recommendations, and interdisciplinary research with the involvement of anthropologists, sociologists, and psychologists should be encouraged. however, certain measures have to be taken and can be corrected, should they be shown as ineffective in properly conducted studies. security measures have been advocated for years ( ) and should be taken to safeguard particularly the most at-risk services. first, staff shortages, so common in public hospitals worldwide, should be acted upon, and increased funding should be allocated to employ more doctors and nurses. hence, the duration of each patient encounter would be augmented, particularly in overburdened public hospitals, allowing the (often young) ( ) doctors to develop a meaningful relationship with the patient. second, healthcare organizations and universities should considerably improve the communication skills of current and future hcws to reduce unrealistic expectations or misunderstanding of patients and families. third, hcws who denounce any verbal or physical violence should be fully supported by their healthcare organizations; this would reduce the huge issue of under-reporting of workplace violence ( , ) . good courses should be organized for hcws to learn how to identify early signs that somebody may become violent, how to manage dangerous situations, and how to protect themselves. prompt communication about delays in service provision should be given to patients and their relatives when waiting times are long because certain conditions are prioritized. alarms and closed-circuit televisions should be placed in the higher-risk departments and in areas where doctors and/or nurses work in isolation. sanctioning of violence by patients, relatives or visitors must be imposed. staff should be increased and security officers should be placed, particularly at night, in remote health posts and emergency departments and at particular times (violence tends to happen in the evenings/nights, when more patients under the influence of drugs and alcohol present); the number of night shifts should be limited ( ) . efforts should be made to improve job satisfaction of hcws ( ) . finally, media should cease to contribute to the general public's distrust toward hcws and institutions. many patients report their negative experiences of medical care to news or media outlets which are highly interested in these stories and very often do not check the information before publishing it ( ) . these biased media reports may exacerbate the tension. all workers have a right to be safe on their job, and healthcare workers are no exception. the idea that violence is inherent to doctors and nurses' work, especially in certain departments, needs to be fought; urgent measures must be implemented to ensure the safety of all hcws in their environment, and the needed resources must be allocated. failure to do so will worsen the care that they are employed to deliver and will ultimately negatively affect the whole healthcare system worldwide. sv had the idea of writing the manuscript and drafted it. fc co-drafted the manuscript. av contributed to the drafting, and reviewed the manuscript. all the authors approved the final version. covid- pandemic response prevalence of workplace violence against healthcare workers: a systematic review and meta-analysis prevalence and policy of occupational violence against oral healthcare workers: systematic review and meta-analysis available online at attacks against health-care personnel must stop, especially as the world fights covid- stop violence against medical workers in china workplace violence and its aftermath in china's health sector: implications from a crosssectional survey across three tiers of the health system violence against health professionals and facilities in china: evidence from criminal litigation records academic college of emergency experts and academy of family physicians of india position statement on preventing violence against healthcare workers and vandalization of health-care facilities in india covid- : indian government vows to protect healthcare workers from violence amid rising cases aggression and violence against primary care physicians -a nationwide questionnaire survey agresiones a profesionales del sector sanitario en españa, revisión sistemática. [aggression to health care personnel in spain: a systematic review guidelines for preventing workplace violence for healthcare and social service workers (osha workplace violence in the health sector. world health organization survey questionnaire onu. rapporto italia. rome ( ) un medico su due ha subito aggressioni. i dati preliminari dello studio fnomceo sancho cantus d. violence against nurses working in the health sector in five european countries-pilot study more than sa hospitals report serious security incidents in past months paramedics, poetry, and film: health policy and systems research at the intersection of theory, art, and practice prevalence of workplace violence types against personnel of emergency medical services in iran: a systematic review and meta-analysis world health organization. violence against healthcare workers workplace violence is associated with impaired work functioning in nurses: an italian cross-sectional study workplace violence against healthcare workers in emergency departments. a case-control study medical malpractice, defensive medicine and role of the "media" in italy addressing risks of violence against healthcare staff in emergency departments: the effects of job satisfaction and attachment style prevalence of type ii and type iii workplace violence against physicians: a systematic review and meta-analysis violence towards healthcare workers: a study conducted in abha city, saudi arabia violence against physicians and nurses in a hospital: how does it happen? a mixed-methods study interventions to prevent aggression against doctors: a systematic review preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention tackling violence against health-care workers physical violence against doctors: a content analysis from online indian newspapers unreported workplace violence in nursing underreporting of workplace violence: comparison of self-report and actual documentation of hospital incidents the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.copyright © vento, cainelli and vallone. this is an open-access article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- -vl zhxyh authors: giallonardo, vincenzo; sampogna, gaia; del vecchio, valeria; luciano, mario; albert, umberto; carmassi, claudia; carrà, giuseppe; cirulli, francesca; dell’osso, bernardo; nanni, maria giulia; pompili, maurizio; sani, gabriele; tortorella, alfonso; volpe, umberto; fiorillo, andrea title: the impact of quarantine and physical distancing following covid- on mental health: study protocol of a multicentric italian population trial date: - - journal: front psychiatry doi: . /fpsyt. . sha: doc_id: cord_uid: vl zhxyh the covid- pandemic and its related containment measures—mainly physical distancing and isolation—are having detrimental consequences on the mental health of the general population worldwide. in particular, frustration, loneliness, and worries about the future are common reactions and represent well-known risk factors for several mental disorders, including anxiety, affective, and post-traumatic stress disorders. the vast majority of available studies have been conducted in china, where the pandemic started. italy has been severely hit by the pandemic, and the socio-cultural context is completely different from eastern countries. therefore, there is the need for methodologically rigorous studies aiming to evaluate the impact of covid- and quarantine measures on the mental health of the italian population. in fact, our results will help us to develop appropriate interventions for managing the psychosocial consequences of pandemic. the “covid-it-mental health trial” is a no-profit, not-funded, national, multicentric, cross-sectional population-based trial which has the following aims: a) to evaluate the impact of covid- pandemic and its containment measures on mental health of the italian population; b) to identify the main areas to be targeted by supportive long-term interventions for the different categories of people exposed to the pandemic. data will be collected through a web-platform using validated assessment tools. participants will be subdivided into four groups: a) group —covid- quarantine group. this group includes the general population which are quarantined but not isolated, i.e., those not directly exposed to contagion nor in contact with covid- + individuals; b) group —covid- + group, which includes isolated people directly/indirectly exposed to the virus; c) group —covid- healthcare staff group, which includes first- and second-line healthcare professionals; d) group —covid- mental health, which includes users of mental health services and all those who had already been diagnosed with a mental disorder. mental health services worldwide are not prepared yet to manage the short- and long-term consequences of the pandemic. it is necessary to have a clear picture of the impact that this new stressor will have on mental health and well-being in order to develop and disseminate appropriate interventions for the general population and for the other at-risk groups. the covid- pandemic and its related containment measures-mainly physical distancing and isolation-are having detrimental consequences on the mental health of the general population worldwide. in particular, frustration, loneliness, and worries about the future are common reactions and represent well-known risk factors for several mental disorders, including anxiety, affective, and post-traumatic stress disorders. the vast majority of available studies have been conducted in china, where the pandemic started. italy has been severely hit by the pandemic, and the socio-cultural context is completely different from eastern countries. therefore, there is the need for methodologically rigorous studies aiming to evaluate the impact of covid- and quarantine measures on the mental health of the italian population. in fact, our results will help us to develop appropriate interventions for managing the psychosocial consequences of pandemic. the "covid-it-mental health trial" is a no-profit, notfunded, national, multicentric, cross-sectional population-based trial which has the following aims: a) to evaluate the impact of covid- pandemic and its containment measures on mental health of the italian population; b) to identify the main areas to be targeted by supportive long-term interventions for the different categories of people exposed to the pandemic. data will be collected through a web-platform using validated assessment tools. participants will be subdivided into four groups: a) group -covid- quarantine group. this group includes the general population which are quarantined but not isolated, i.e., those not directly exposed to contagion nor in contact with covid- + individuals; b) group -covid- + group, which includes isolated people directly/indirectly exposed to the virus; c) group -covid- healthcare staff group, which includes firstand second-line healthcare professionals; d) group -covid- mental health, which includes users of mental health services and all those who had already been diagnosed with a mental disorder. mental health services worldwide are not prepared yet to manage the short-and long-term consequences of the pandemic. it is necessary to have a clear picture of the impact that this new stressor will have on mental health and well-being in order to develop and disseminate appropriate interventions for the general population and for the other at-risk groups. keywords: pandemic, global mental health, post-traumatic stress disorder, burn-out, anxiety, depression, resilience background the ongoing covid- pandemic represents an unprecedented event in terms of consequences for physical and mental health of individuals and for the society at large ( ) ( ) ( ) ( ) . in order to reduce the spread of the virus, national and international bodies and institutions have ordered quarantine, physical distancing, and isolation almost everywhere in the world. however, the psychological consequences of quarantine, such as frustration, loneliness, and worries about the future are well-known risk factors for several mental disorders, including anxiety, affective disorders, and psychoses ( ) ( ) ( ) . from a medical and sociological viewpoint, the pandemic caused by covid- represents a unique event, since it does not resemble any other previous traumatic event, such as earthquakes or tsunamis ( ) . in those cases, the traumatic factors are usually limited to a specific area and to a given time; affected people know that they can "escape" from the event. on the contrary, in the case of covid- pandemic, the "threat" can be everywhere and can be carried by every person next to us ( ) ( ) ( ) . therefore, people living in cities most severely impacted by the pandemic are experiencing extremely high levels of uncertainties, worries about the future and fear of being infected. the only comparable studies are those carried out during the sars outbreak ( ) ( ) ( ) ( ) ( ) . those studies showed that people experienced fear of falling sick or dying, feelings of helplessness, increased levels of self-blame, fear, and depression ( ) ( ) ( ) ( ) . during quarantine and physical distancing, internet and the social media can be useful in reducing isolation and increasing opportunities to keep in contact with family members, friends, and co-workers at any time ( , ) . however, internet may also represent a risk factor for mental disorders, in particular internet gaming disorder. moreover, internet can also have a negative impact on mental health of the most vulnerable people, such as those who live alone or the elderly, since it spreads an uncontrolled amount of information (a situation known as "infodemic"). in the current pandemic, the impact of quarantine and physical distancing on the mental health of the general population has been explored only in a few studies, mostly conducted in china, where the pandemic started ( ) ( ) ( ) . qiu et al. ( ) found that % of the population experienced psychological distress; in particular, those more vulnerable to stress and more likely to develop post-traumatic stress disorder were women and individuals aged between and years or older than years. moreover, people were more concerned about their own health and that of their family members, while less concerned about leisure activities and relationships with friends ( , ) . after china, italy has been the first country to face the contagion of covid- and one of the countries with the highest number of deaths due to this coronavirus (http://www. salute.gov.it/portale/nuovocoronavirus/). on march , the lockdown status has been declared by the italian government. this status included the definition of specific containment and quarantine measures, such as the interdiction of all public meetings and strict movement restrictions (i.e., possibility to go out only for working, serious health reasons, or other urgent needs). these containment measures have been prolonged until may . moreover, the expected psychosocial and emotional reactions to the pandemic observed in the general population may be significantly different in the chinese and italian populations due to their socio-cultural characteristics and historical contexts, which obviously impact on people's behaviors and attitudes. furthermore, the organization of public health system is different in italy compared to china and other eastern asian countries, also due to financial constraints. in fact, although in those countries the model of care has shifted in the last years to become more similar to a western model of care, it has to be acknowledged that years is a relatively short period of time, and differences may still persist. methodologically rigorous studies are needed in order to evaluate the impact of covid- and quarantine measures on the mental health of italian population. these data will help us to develop appropriate interventions for managing the psychosocial consequences of the pandemic ( ) ( ) ( ) . the present study has been developed with the aims to: a) evaluate the impact of covid- pandemic and its containment measures on mental health of the italian population; b) to identify the main areas to be targeted by supportive long-term interventions for the different categories of people exposed to the pandemic. the "covid-it-mental health trial" is a no-profit, not-funded, national, multicentric, cross-sectional population-based trial involving the following eleven sites: university of campania "luigi vanvitelli" (naples), università politecnica delle marche (ancona), università milano bicocca, università "statale" (milan), university of perugia, university of pisa, sapienza university of rome, "cattolica" university of rome, university of trieste, university of ferrara; the center for behavioral sciences and mental health of the istituto superiore di sanità (rome). the department of psychiatry of the university of campania "luigi vanvitelli" in naples is the coordinating center, which has originally conceived the study idea and design. an online survey has been set up through eusurvey, a web platform launched in by the european commission. the application, hosted at the department for digital services (dg digit) of the european commission, is available to all eu citizens at https://ec.europa.eu/eusurvey. the survey will be online from march to june , (https://ec.europa.eu/ eusurvey/runner/covidsurvey ). the survey takes approximately - min to be completed. participants can stop the survey at any time and save their answers as "draft" on the web-platform. furthermore, participants can interact with the principal investigator of the study and with all researchers through email messages at any time during and after study participation. participants will be subdivided into four groups: a) group -covid- quarantine group. this group includes the general population which are quarantined but not isolated, i.e., those not directly exposed to contagion nor in contact with covid- + individuals; b) group -covid- + group, which includes isolated people directly/indirectly exposed to the virus; c) group -covid- healthcare staff group, which includes firstand second-line healthcare professionals; d) group -covid- mental health, which includes users of mental health services and all those who had already been diagnosed with a mental disorder. the survey addresses the italian population aged over years through a multistep procedure: ) email invitation to health professionals and their patients; ) dissemination of the link through social media channels (facebook, twitter, instagram) and the mailing lists of national psychiatric associations; ) involvement of national associations of stakeholders (e.g., associations of users/carers); ) official communication channels (e.g., university websites; websites of the hospitals directly involved in the management of the pandemic). the invitation letter includes information on study purposes and confidentiality. the provision of the informed consent is mandatory in order to start the survey. the snowball sampling procedure-without the definition of strict inclusion/exclusion criteria (except that of age limit)-will give us the opportunity to recruit a large sample of the italian population and to evaluate the effect of the studied variables on the outcome measures. the survey includes the following self-reported questionnaires: the general health questionnaire - items (ghq- ) ( ); the depression, anxiety and stress scale - items (dass- ) ( ); the obsessive-compulsive inventory -revised (oci-r) ( ); the insomnia severity index ( ) ; the severity-of-acute-stress-symptoms-adult ( ); the suicidal ideation attributes scale (sidas) ( ); the impact of event scale - items ( ); the ucla loneliness scale -short version ( ) ; the brief cope ( ); the post traumatic growth inventory short form ( ) ; the connor-davidson resilience scaleshort form ( ) ; the multidimensional scale of perceived social support ( ); the pattern of care schedule (pcs)-modified version ( ); the maslach burnout inventory (only for health professionals) ( ) . respondents' main socio-demographic characteristics, as well as data on their internet use, will be collected through an ad hoc schedule. all assessment instruments used for the study are detailed in table . the primary outcome of the study is the global score at the dass- . this choice is due to the fact that this assessment measure has already been used in a large population study carried out in china, thus giving us the opportunity to compare the italian situation with the chinese one ( ) . our study hypothesis is that the pandemic and the related containment measures are associated with higher levels of depressive and anxiety symptoms in the surveyed population compared to a community italian sample not exposed to the pandemic ( ) . furthermore, a significant difference between groups will be identified (covid- quarantine group = covid- healthcare professional second-line < covid- + group = covid- healthcare professional first-line group < covid- mental health group). in the covid- quarantined group, the severity of obsessivecompulsive symptoms, evaluated through the oci-r, the perceived loneliness and suicidal ideation will be considered as secondary outcome measures. in the covid- + patient group, the severity of post-traumatic symptoms at the severity-of-acute-stress-symptoms-adult scale will be considered. the hypothesis is that post-traumatic symptoms are more severe in this group compared to the other ones. in the covid- health staff group, the presence of burn-out symptoms, in particular mental exhaustion, and suicidal ideation will be considered. we anticipate that first-line professionals will report higher levels of mental exhaustion and suicidal ideation compared to second-lines staff members. in the covid- mental health group, the secondary outcome measures will include the adoption of maladaptive coping strategies (e.g., drinking alcohol) and a poor resilience style. patients with pre-existing mental disorders are expected to adopt more maladaptive coping strategies and poorer resilience styles compared to the other three groups. the use of internet and social media will be tested as possible moderator of the impact of pandemic and quarantine ( figure ) . moreover, the exposure time to covid- and to the related containment measures will be tested as possible mediators of the severity of the clinical symptomatology. finally, the other exploratory outcomes will include the variety of coping strategies and resilience styles as well as the different levels of post-traumatic growth. statistical analyses will be conducted according to a multistep plan. missing data will be handled using the multiple imputation approach ( ) . descriptive statistics will be calculated for the dependent and confounding variables. a bilateral alpha of . is considered, and error and confidence intervals are calculated at %. the analytic plan will include: ) data cleaning of the online dataset and replacement of missing values; ) descriptive statistics of the general characteristics of the recruited sample, in terms of levels of depressive and anxiety symptoms, posttraumatic and stress-related symptoms, insomnia, satisfaction with life, suicidal ideation, hopelessness, post-traumatic growth, resilience, coping strategies, and social support; ) sub-groups analyses based on the level of exposure to the pandemic (i.e., covid- quarantine group vs. covid- + patients group vs. covid- healthcare staff group vs. covid- mental health group); ) calculation of a propensity score, in order to adjust our findings for the likelihood of being exposed to the pandemic and to the quarantine ( , ) . this method is adopted since it produces a better adjustment for differences at baseline, rather than simply including potential confounders in the multivariable models. the independent variables used for calculating the propensity score will include gender, age, socio-economic status, and geographical region. the obtained propensity score will be used to weight the observations in the multivariable analyses. in the final regression model, the inverse probability weights, based on the propensity score, will be applied in order to model for the independence between exposure to the pandemic/ quarantine and mental health outcomes and estimation of causal effects ( , ); ) development of a structural equation model (sem), in order to evaluate the possible role as mediators and moderators of coping strategies, post-traumatic growth and usage of social networks on the severity of depressive and anxiety symptoms, post-traumatic and stress-related symptoms, suicidal ideation, and hopelessness. in order to improve the external validity and generalizability of our findings, all analyses will be controlled for the impact of confounding variables, such as age, gender, and geographical region. data will be stored in an online dataset by the coordinating center. for safety reasons, the dataset will be protected by a twostep password. it will be possible to export data in compatible formats with common calculation software (e.g., microsoft access and excel) and in specific softwares (e.g., spss and stata) for the statistical analyses. this study is being conducted in accordance with globally accepted standards of good practice, in agreement with the declaration of helsinki and with local regulations. the study protocol has been approved by the ethical review board of the university of campania "l. vanvitelli" (protocol number: /i). our survey will give us the opportunity to describe the impact of the pandemic on the mental health of different subgroups of the italian population. in fact, the analyses will be run according to the four subgroups of respondents: the general population not directly affected by the virus (covid- quarantine group); people who have had a direct or indirect contact with the virus (covid- + patients group); those working in health care units as first or second-line staff (covid- healthcare staff group); people with mental health problems, independently from the contact with the virus (covid- mental health). this choice is due to the evidence that stress and traumas have a different impact on different target groups ( , ( ) ( ) ( ) . in the covid- -quarantine group, we anticipate that the pandemic and the related containment measures will increase the levels of stress, anxiety and depression, as well as other stress-related symptoms. in particular, physical distancing has obviously changed the patterns of daily routine in order to mitigate the spread of the disease, with serious consequences on mental health and well-being in both the short-and long-term ( ) . similar consequences would require immediate efforts for developing preventive strategies as well as direct interventions aiming to mitigate the impact of the outbreak on individual and population mental health. the longer the pandemic will last the most the ordinary life of the general population will be seriously affected. in particular, zhang et al. ( ) have highlighted the need to pay attention to the mental health of people who have not been directly infected by the virus though have been forced to stop all their activities during the outbreak. these people represent the most susceptible group to the detrimental impact of quarantine and physical distancing measures adopted during the lockdown. moreover, during the current pandemic, it is reasonable to expect that the incidence of severe mental disorders will increase, but also that of other mental health disturbances not reaching the threshold for a full-blown diagnosis ( ) . however, currently available data are based on studies carried out in china and the different socio-cultural context may limit the generalizability of findings to the italian and western contexts. therefore, we consider essential to collect italian data in order to develop data-driven guidelines for an adequate management of mental health problems during the emergency and the post-emergency phases. in fact, this survey will represent the starting point for developing, validating, and implementing psychosocial supportive interventions ( , ) , as discussed later in this paper. we hypothesized that internet and social media can play a buffering role in the development of psychiatric symptoms ( , ) . it may be that online contacts and interactions will limit the detrimental effects of social isolation ( ) . moreover, internet can represent the ideal setting for providing supportive interventions through tele-mental health applications ( - ). however, the positive effect of internet and social media has to be confirmed yet, since it is only speculative at this stage. in the covid- + patient group (i.e., those with a direct or indirect contagion), the impact on mental health has been mostly neglected during the acute emergency phase. of course, this has been due to the fact that the infection is a potentially lifethreatening condition, as confirmed by the need for hospitalization in intensive care units for many patients ( ) . in particular, the experience of being isolated in the hospital, the perceived danger, uncertainty about own physical conditions and the fear of dying alone can be considered risk factors for the development of post-traumatic, anxiety, and depressive symptoms ( , ) . the only study conducted in china so far has documented that over % of covid+ patients admitted to the hospital reported significant post-traumatic stress symptoms ( , , ) . furthermore, the authors found that providing patients with psychoeducational intervention is well received and perceived as helpful and useful by users. as regards the effects on mental health of those working in health care units as first-line or second-line staff (covid- healthcare staff group), we expect that many health professionals will experience symptoms of burn-out, including mental exhaustion, irritability, detachment from reality, and insomnia. in a survey involving medical and non-medical health workers, zhang et al. ( ) found a higher prevalence of insomnia, anxiety, depressive symptoms, somatization, and obsessive-compulsive symptoms in mental health staff. moreover, front-line medical staff working in close contact with infected patients (e.g., staff professionals working in the departments of respiratory, emergency, infectious disease, and intensive care unit) showed higher scores on depressive/anxiety symptoms and had a twofold increase in risk to develop a mental health problem ( ) ( ) ( ) ( ) . however, the effect on suicidal ideation of health professionals has not been investigated yet and will be the focus of one of our work-packages. finally, the pandemic will affect the mental health status of people who already suffer from mental health problems, independently from the contact with the virus (covid- mental health group). although the effects of the coronavirus on mental health have not been systematically studied, it is likely that the covid- will have detrimental effects on patients with pre-existing mental health problems. many patients with severe mental disorders have been overlooked during the pandemic, although they can have a higher risk of contracting the virus and of death considering the higher prevalence of somatic comorbidities compared to general population and the difficulties in accessing health services ( ) . however, if protracted, social isolation may increase the risk of recurrences of episodes of mental disorders, beyond triggering the onset of new mental disorders in most vulnerable people. moreover, objective social isolation and subjective feelings of loneliness are associated with a higher risk of suicidal ideation and suicide attempts ( ) . for many persons with mental disorders, being alone is a heavy burden, far beyond that experienced by many other persons ( ) . in patients with pre-existing anxiety disorders or obsessivecompulsive disorder, we expect an exacerbation or worsening of their clinical symptoms. moreover, the fact that there is not (yet) a definitive treatment for the covid infection represents another potential stressor, further increasing the levels of anticipatory anxiety and reducing personal functioning. in our study, both obsessive-compulsive and anxiety symptom clusters will be evaluated through reliable and validated questionnaires. we believe that our study has several strengths, which should be highlighted. first, this is the first national multicentric, noprofit study carried out in italy with a rigorous methodology for evaluating the impact of pandemic and quarantine on mental health. second, the development of a web-based platform for data collection will give us the opportunity to recruit a high number of participants. based on previous population surveys carried out in italy, an ideal target would have been , participants, but this target has been reached in only days. therefore, we expect to reach more than , people within the study period. a third relevant strength of our study is the selection of validated and reliable assessment instruments, which are available and validated in several languages. the next step of the project will be to adapt our survey to the european level, by involving several countries. fourth, several psychopathological dimensions will be evaluated, not only those usually assessed following natural disasters, such as the post-traumatic and depressive-anxious dimensions. in this study, we will also evaluate the obsessive-compulsive spectrum, the suicidal ideation, the maladaptive use of internet, among the others, which represent novel targets for psychiatrists ( , ) . our study has obviously also some limitations. in particular, the study sample includes the adult population only, due to existing restrictions related to the provision of informed consent of children and adolescents in italy. however, it is likely that the pandemic will have a detrimental impact on the mental health of adolescents as well ( , ) . moreover, being exposed to a traumatic event during early life is associated with alterations in the social, emotional, and cognitive development and could determine a variety of impairment in the adulthood. the effects of the pandemic on children and adolescents will be evaluated in an ad hoc study, in which we will explore the relationship between parents and their underage children during the pandemic. another limitation is related to the recruitment process, which might partially bias our findings, since only persons interested in the topic of the survey may have voluntarily participated. however, we expect that most people are interested in participating in the survey given the global magnitude of the current traumatic threat with collective psychological and social reactions. another possible limitation of our study is the choice to use a web-based online survey, which may have limited the participation of people not having access to the internet or not familiar with online tools, particularly the elderly. the cross-sectional design of the study does not allow an evaluation of changes over time as regards the levels of severity of symptoms. however, in order to overcome this possible bias, we will compare our findings with those already available from the italian population ( ) and will adopt a propensity score approach in order to understand the impact of the duration of exposure to the pandemic on the risk of developing psychiatric symptoms. with this methodology, we will be able to evaluate the levels of post-traumatic growth and the type of resilience styles in the study population in order to identify possible critical areas to be targeted in the post-acute phase. however, these psychological constructs are slow to change, and this is why we will promote a second wave of the survey, which will start six months after the end of the "lockdown phase" in italy. finally, the survey link can be used multiple times in order to allow sharing and re-posting it. this methodological choice could bias the findings, since the same person can potentially compile the survey several times. however, this methodological choice was due to the adoption of the "snowball" sampling, and it is rather unlikely that someone can compile the same long survey more than once. based on the findings of this study and on our previous work in the development of psychosocial interventions ( - ), we aim to develop a psychosocial intervention which will include elements of classic psychoeducation, cognitive-behavioral therapy, and motivational intervention ( ) ( ) ( ) ( ) ( ) . in particular, we are developing an experimental intervention which includes information on the mental health consequences of the pandemic and on strategies to prevent them; practical advices for promoting healthy lifestyle behaviors (e.g., healthy eating, regular sleeping patterns, physical activity, etc.); stress-management techniques; communication strategies; problem-solving skills. based on participants' needs, additional sessions on suicide prevention, burn-out, and internet dependence may be provided. the intervention will include face-to-face sessions and telemental health sessions ( , ) . information will be provided through instant messages (e.g., chatbot), email contacts, and the development of an ad hoc app. the modules of the intervention will be adapted according to the characteristics and the needs of the four above-mentioned target groups. in particular, in the covid- quarantine group, the main focus of the intervention will be the improvement of healthy lifestyle behaviors; for the covid- + patients group, the intervention will include a specific focus on post-traumatic symptoms and on the risk of being socially stigmatized; for the covid- healthcare staff group, specific sessions will be dedicated to the burn-out syndrome and the management of stressful situations; for the covid- mental health group, sessions on resilience, coping strategies, and the detection of early warning signs of relapses will be included. the proposed experimental intervention will be tested in a randomized controlled trial which will start when the acute phase of the pandemic will be over, and the control group will be represented by an informative group intervention on the effects of the pandemic on mental health. moreover, our survey is going to be translated into different languages in order to assess the impact of the pandemic in other european countries. the pandemic and the quarantine may have a detrimental impact on mental health. an increase of psychiatric symptoms and of mental health problems in the general population is expected. most health professionals working in isolation units and resuscitation departments very often do not receive any training or support for their mental health care. mental health services worldwide are not prepared to manage the short-and long-term consequences of pandemic. it is necessary to have a clear picture of the impact that these new stressors are having on mental health and well-being in order to develop and disseminate appropriate preventive interventions for the general population as well as for the different atrisk groups. this study is being conducted in accordance with globally accepted standards of good practice, in agreement with the declaration of helsinki and with local regulations. the study protocol has been approved by the ethical review board of the university of campania "l. vanvitelli" (protocol number: /i). vg, gais, ml, vv, and af designed the study and wrote the protocol. ua, gc, cc, fc, bdo, mn, mp, gabs, at, and uv revised the draft of the paper. all authors contributed to the article and approved the submitted version. we are very grateful to the healthcare professionals, patients, and general population who have dedicated their time to participate in our study. the consequences of the covid- pandemic on mental health and implications for clinical practice the psychological impact of 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study protocol psychoeducational intervention for perinatal depression: study protocol of a randomized controlled trial family management of schizophrenia: a controlled study of clinical, social, family and economic benefits a protection motivation theory of fear appeals and attitude change toward a theory of motivational interviewing scaling up psychological treatments for common mental disorders: a call to action hickie ib. the role of new technologies in monitoring the evolution of psychopathology and providing measurement-based care in young people the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. key: cord- -aowxr authors: stoeva, preslava title: dimensions of health security—a conceptual analysis date: - - journal: glob chall doi: . /gch . sha: doc_id: cord_uid: aowxr discussions of the politics and practicalities of confronting health security challenges—from infectious disease outbreaks to antimicrobial resistance and the silent epidemic of noncommunicable diseases—hinge on the conceptualization of health security. there is no consensus among analysts about the specific parameters of health security. this inhibits comparative evaluation and critique, and affects the consistency of advice for policymakers. this article aims to contribute to debates about the meaning and scope of health security by applying baldwin’s ( ) framework for conceptualizing security with a view to propose an alternative framing. asking baldwin’s concept‐defining questions of the health security literature highlights how implicit and explicit assumptions currently place health security squarely within a narrow traditionalist analytical framework. such framing of health security is inaccurate and constraining, as demonstrated by practice and empirical observations. alternative approaches to security propose that security politics can also be multiactor, cooperative, and ethical, while being conscious of postcolonial and feminist critique in search of sustainable solutions to existential threats to individuals and communities. a broader conceptualization of health security can transform the politics of health security, improving health outcomes beyond acute crises and contribute to broader security studies’ debates. discussions of health security periodically climb up the global political agenda, mostly in response to global health-related concerns and challenges-from public health emergencies of international concern and pandemics, e.g., h n , ebola, zika, and the covid- pandemic, [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] to concerns about antimicrobial resistance, defined by the world health organisation (who) as a fundamental threat to human health, development and security, [ ] and the "silent" noncommunicable disease pandemic. [ , ] academic interest in and appetite for health security analysis has not abated either, as indicated by recent "lancet" contributions. [ , [ ] [ ] [ ] [ ] the response to the global conceptualizations of health security emerged over time in response to specific health challenges, political and institutional developments. [ , ] academic analysis has broadly (with a few exceptions) sought to fit health into mainstream security studies paradigms instead of using health to broaden security debates through reflection on practice and the engagement of emerging security paradigms. there is a notable reliance on the securitization framework promoted by the copenhagen school [ ] to explain the rise to prominence of health concerns in security politics, but that, it will be argued here has supported, validated, even justified a narrow, privileged view of health security. in his overview of the multiple meanings of health security, mcinnes argues that just like "security," "health security" is "essentially contested" and it is therefore not possible to reach an agreement on the meaning and application of the term. [ ] he observes that the different framings of health security are "not amenable to a single set of agreed criteria" because they have been constructed to serve a particular purpose, are premised on different sets of assumptions, have different uses and privilege diverse interests and agendas. [ ] such observations, however, default on the need for systematic discussion and critical reflection on the way health security has been conceptualized, or the interests that such conceptualization might be serving. the following brief review of the most common health security conceptualizations in historic context highlights the limited engagement with existing specialist knowledge both from across the spectrum of security studies paradigms including critical security studies, postcolonial and feminist approaches, with specialist knowledge of foreign policy, foreign policy analysis, governance, and global health governance or with key developments in practice. the failure to engage with the broader spectrum of existing knowledge constrains the diversity of discussions, interdisciplinary dialog and learning, as well as the possibility of progressive policy impact. links between national security and infectious disease outbreaks were initially identified by us analysts in the mid to late s. [ ] [ ] [ ] [ ] [ ] [ ] the promotion of health in developing countries was included in us national security strategies (nss) in - . [ ] [ ] [ ] infectious diseases were described as a significant challenge in low and middle-income countries, contributing to a slowdown in economic growth. the us "nss a national security strategy for a new century" was the first such document to state that health problems "can undermine the welfare of us citizens, and compromise our national security, economic and humanitarian interests abroad for generations." [ ] health issues of particular interest to the united states included food-borne diseases from imported foodstuffs, new and emerging infectious diseases and hiv/aids. the bush administration re-iterated concerns about the threats posed by biological weapons and pandemic health threats but did not prioritize health-related security as much. [ ] considerations about national and global health made their way back into the us nss in and under the obama administration. pandemic disease was considered a threat to "the security of regions and the health and safety of the american people." [ ] the first uk national security strategy published in claimed it was premised on a broader conceptualization of national security that included "threats to individual citizens and to our way of life, as well as to the integrity and interests of the state" [ ] and listed infectious diseases (particularly the threat of a global influenza pandemic) and bioterrorism as national security concerns. the uk national security strategy defined the risk of a severe influenza pandemic as one of the top three civil emergencies risks. [ ] while the qualification "broader conceptualization" is intended to refer to a move away from concerns of defense and military security, the narrow focus on bioterrorism and communicable disease is symptomatic of traditional, state-centric thinking about security from acute threats originating outside of it. fidler ( ) provides detailed analysis of the practical ways in which the linkages between public health and national security have emerged. he concludes that the realpolitik perspective on national security is driving the development of the concept of public health security in the united states despite three other possible formulations-common, human and ecological security. [ ] rushton ( ) also observes that health security continues to be framed in narrow traditional terms as national security and underpinned by particular concerns of interest to rich industrialized states, which shape a narrow discourse that largely disregards the needs of the global south. [ ] mcinnes adds that "health issues are not identified as national security risks by reference to an explicit set of criteria but rather have arisen in an ad hoc manner and been agreed to intersubjectively by key national and international actors." [ ] these observations inadvertently contribute to normalizing dominant political discourses about the paramount nature of the national interest, the centrality of the interests of powerful states and the relevance of only acute health threats to security thinking. national security is often considered the key objective of foreign policy. hiv/aids was framed as a foreign policy problem by the clinton administration's interagency working group on emerging and re-emerging infectious diseases' report "infectious disease: a global health threat," and the national intelligence council's report "the global infectious disease threat and its implications for the united states." fidler's analysis, however, mistook us' foreign policy focus on emerging and reemerging communicable diseases and bioterrorism for a global trend and a normative shift, claiming that health had achieved "pre-eminent political value for st century humanity." [ ] kickbusch ( ) argued that the us had shaped the international agenda to fit in with its national interests and priorities and in doing so had preferenced a "unilateral hegemonic approach" to multilateral cooperation. [ ] the implications of us leadership in shaping the international health security agenda remain understudied, and yet critically relevant to what is included and excluded from that agenda. the political recognition of health issues as a matter of foreign policy by other states was marked by the oslo ministerial declaration on global health and foreign policy (ministers of foreign affairs of brazil, france, indonesia, norway, senegal, south africa, and thailand, ) and the adoption of un general assembly resolution / , which "recognizes the close relationship between foreign policy and global health and their interdependence and… urges member states to consider health issues in the formulation of foreign policy." [ ] the reason given for linking health policy with foreign policy at the international level was that health problems of global magnitude were deemed to require cooperative solutions. the international community continues to struggle, however, to find such cooperative state-led solutions, as illustrated by the response to the ebola crisis [ ] and by the current response to the covid- pandemic, which has broadly been marked by states leading individual responses. considering the inclusion of health issues on states' foreign policy agendas as novelty, of course, ignores a long tradition of state cooperation dating back at least to the th century. [ ] the analysis of health concerns as issues of national security and foreign policy suffers from some prominent shortcomings. discussions of foreign policy and health make virtually no reference to analytical frameworks from the field of foreign policy and foreign policy analysis, failing to draw on its methodologies, paradigms and empirical knowledge. in other words, the presence of health on foreign policy agendas and its construction as a threat to national security is observed in practice, but not sufficiently interrogated in analytical terms. furthermore, studies often assume generalizability beyond one state (most commonly the usa), which has skewed analysis and aligned it almost exclusively with dominant paradigms of great-power politics, failing to reflect on how health features in the foreign policy agendas of a broader spectrum of states. health concerns have been conceptualized as international security challenges in a number of high-level policy pronouncements. in her role as director general of the world health organisation (who), gro harlem brundtland argued that health was an underlying determinant of development, security, and global stability and that in an interdependent world the functional separation between domestic and international health policy lost its meaning. [ ] brundtland advocated international cooperation in addressing health-related global threats because "[a] world where a billion people are deprived, insecure and vulnerable, is an unsafe world." [ ] these observations are poignantly relevant years on in the fight against the covid- pandemic. further recognition of health issues as "threats to international peace and security" is evident in un security council resolutions. security council resolution ( ) acknowledged the growing impact of the hiv/aids pandemic in africa on social instability and emergency situations, and stressed that if left unchecked, it "may pose a risk to stability and security." [ ] this historic resolution was followed by two others-resolution ( ) and ( ) respectively on hiv/aids and ebola. the eu security strategy ( ) is another example of framing health as an international security threat. it links infectious diseases to poverty, economic failure, political problems and ultimately violent conflict, [ ] and also notes the threat posed by the potential rapid spread of new diseases and the devastation caused by the hiv/aids pandemic. the concept of international security has been discussed almost in passing in the security literature by buzan ( ) , describing it as focused "on the sources and causes of threats, [with its]… purpose being not to block or offset the threats, but to reduce or eliminate them by political action." [ ] this definition is in contrast to his discussion of national security, which focuses on "reducing the vulnerabilities of the state… by increasing self-reliance, or by building countervailing forces to deal with specific threats. [ ] the concept of 'world security" is in the words of ken booth "more encompassing than the notion of international security… [including] the structures and processes within human society… that work toward the reduction of the threats and risks that determine individual and group lives." [ ] both concepts-of international and world security-are very relevant to thinking about mechanisms to reduce health insecurity, but are rarely used by analysts to frame interrogations of the nature, scope and focus of health security politics. it is curious that there has been so little conceptual analysis of these political statements pronouncing health as a global/international security concern. health security as an aspect of human security has received the least attention in the health security literature. health is one of the seven areas identified by undp's "human development report" ( ) as pertinent to human security. much contemporary analysis, however, focuses on the mechanisms through which health affects human security, and not on the political or policy implications of promoting and pursuing human security, or indeed on what such health security policy might look like. health as a human security issue is broadly defined and premised on who's definition of health as "a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity." [ ] this in turn means a broader view of the range of relevant health threats-going beyond communicable diseases and bioterrorism, to include for example noncommunicable diseases, neglected tropical diseases; as well as considerations about the social determinants of health. this view considers "the many other health challenges faced by more vulnerable groups who are amongst those most affected by the burden of disease." [ ] proponents of this approach further note that health threats are experienced most acutely by marginalized groups and communities and that gains in health anywhere in the world benefit everyone everywhere. [ ] takemi et al. argue that a human security approach can contribute to improvements in health because it focuses on the needs of communities, recognizes people's vulnerabilities and strengthens the interface between protection and empowerment. [ ] critics have argued that human security does not have sufficient political traction, [ , ] building on critiques of the concept as being too broad to serve as a guide for academic research or governmental policy making. [ ] while the term "human security" might have lost political traction, however, the value of promoting human-centered security is deeply embedded in existing human rights norms and humanitarian law, as well as doctrines such as the responsibility to protect. this calls for further substantive analysis of the positioning of health security in a broader normative and political context. as the commission on human security has suggested individual and state security need to be considered as complementary-an avenue for analysis that remains largely unexplored. [ ] all the different framings above share a conscious or an unconscious drive to embed public health concerns into existing frameworks for thinking about security. as barkawi and laffey posit, however, "security relations today [sic] are about the contradictions between old security logics and new security problematics." [ ] health security politics provide an accurate illustration of these tensions between understandings of security as a zero-sum game between great powers and the everyday realities of challenges posed by disease and ill-health, affecting the life and well-being many across the world. these tensions, however, cannot be reconciled by the old security theories, premised on old security logics, because they are partly the cause of the problem. analysis, instead, needs to draw on practice and emerging security paradigms. new frameworks for analyzing security politics include, but are not limited to cooperative security, [ ] [ ] [ ] [ ] [ ] multiactor approaches to security politics, [ , ] ethical security studies. [ ] these are particularly relevant to analyzing health security politics, which, as will be discussed, include complex interactions between public and private actors, aim to address issues that transcend national borders, and affect individuals and groups more acutely than states. a synthesis between alternative security approaches and empirical insight would provide a solid foundation for a more pragmatic understanding of how the political realms of health and security intersect and indeed interact. conceptual clarity is key in situating analysis, generating comparable findings, and facilitating understanding of commonality and diversity, argues baldwin. [ ] it is the first step in facilitating meaningful scholarly engagement and the development of policy proposals that are "comparable with each other and with the policies of pursuing other goals" and can easily be evaluated by end users. [ ] the questions that define the concept of security are: "security for whom? security for which values? how much security? from what threats? by what means? at what cost?" [ ] this framework is applied here with a view to highlighting implicit and explicit assumptions made about the nature and scope of health security politics in the existing literature. some of the questions from baldwin's framework have been used to frame discussions of health security already in two influential works by simon rushton-"global health security: security for whom? security from what?" [ ] and security and public health. [ ] there are two main issues with these worksfirst, rushton's analysis, as will be discussed below, is cautious and does not push conceptual boundaries far enough to explore the outer limits of health security; and secondly, these works only partially engage with baldwin's framework, meaning that rushton's analysis does not give us a ° view of the implications of assumptions made in relation to each aspect of the concept of health security. mainstream theories of international relations (ir) and security studies assume the state as the main referent object of security. [ ] current health security analysis is also predominantly premised on this assumption. while some studies assert it explicitly, [ , , ] most do so implicitly by either discussing security only in relation to health threats that challenge states' strategic interests, [ , , ] or by examining health as a foreign policy or national security concern, both of which are by definition state-centric. [ , , , ] the main consequence of focusing on the state as the sole referent object of security is that only a narrow set of health problems, which are perceived to cause acute state instability, state failure or destabilize other interstate relations, qualify as relevant security challenges, while many others remain ignored, excluded, and understudied. direct threats to state security are perceived to emanate from diseases that cause large-scale morbidity and mortality, cross national borders and affect populations, rather than just individuals. [ ] it has been argued that such diseases are destabilizing for states only in extreme circumstances-by affecting the health status of military personnel or peacekeepers, [ ] by undermining state structures and political stability, by exacerbating existing political instability, or by impacting the labor force and the economy, and reversing years of economic development. [ ] [ ] [ ] even in these situations, however, the impact of ill-health would be most acutely felt by individuals and communities. diseases (both communicable and noncommunicable) pose an existential threat to individuals, affecting their own and their families' sense of daily security, stability, predictability, well-being, economic, and development prospects, in a way that cannot be experienced at state-level. what is more, ill-health is the most relevant existential threat to people with out of the top causes of death worldwide being healthrelated, [ , ] which makes a strong argument for promoting human-centered security. baldwin argues that conceptually, and for purposes of specifying the concept of security, individuals, states, the international community can all be considered relevant referent objects of security. [ ] but while such analysis is central to gaining a more accurate and nuanced understanding of dynamic and evolving security problematics globally, existing security, and international relations paradigms are poorly equipped for such multiscalar analysis. traditional ir theories consider the preservation of the sovereignty, autonomy, and territorial integrity of states as core values to be secured. [ ] [ ] [ ] the raison d'etre of the state is to protect itself from external invasion or transgression, they argue, and it is only by ensuring its own security that the state is able to guarantee the security of its people. baldwin argues that in practice, other values are sometimes added to the national security agenda and that the values, which are being pursued by security politics ought to be clearly specified, so as to assist analysts in evaluating their relative importance and resource needs in comparison with other policy objectives. [ ] importantly, baldwin further argues against specifying security objectives in absolute terms, because absolute security is unattainable, which justifies his next question about the degree of security sought in a particular issue area. political and normative developments in international politics demonstrate that the spectrum of values that states have agreed to secure is growing. this is illustrated by the emergence of concepts such as human development, [ ] human security, [ ] responsibility to protect. [ ] [ ] [ ] increasing attention has been paid to the protection of civilians in inter-state conflicts through the growing body of international humanitarian law. states have further committed to seeking individual criminal responsibility for acts of genocide, war crimes and crimes against humanity by accepting the jurisdiction of the international criminal court and thus offering further protection for people from the exigencies of uncontrolled power. [ ] the influence that these norms and values are having on security policy is understudied by both traditional and critical security studies. these norms demonstrate a shift in values toward securing and protecting individual life and population well-being, alongside traditional state security. most analyses of health security do not engage in depth either with this evolving international normative context or with security studies paradigms that are more human-centered. health security studies struggle to effectively reconcile the values pursued by public health-i.e., the protection and promotion of the health of communities and traditional security studies-identified as existential threats to states. [ ] the values to be secured according to this literature, therefore, continue to be the stability and integrity of states-by means of preventing internal instability and state vulnerability that may be caused by high morbidity and mortality, and external instability caused by state failure and conflict. since assumptions about what values ought to be secured are implicit in the health security literature, the implications of these choices for security policy have not been sufficiently evaluated. at first glance, this question might appear futile and its answer obvious-surely, more security is always better. baldwin clarifies its significance-"[i]n a world in which scarce resources must be allocated among competing objectives, none of which is completely attainable, one cannot escape from the question 'how much is enough?" and one should not try." [ ] morgenthau sets out the realist position on this question: "all nations must allocate their scarce resources as rationally as possible" to guarantee national survival. [ ] offensive and defensive neorealists agree, but disagree on whether state security is best achieved through gaining the "appropriate amount of power" [ ] or through the maximization of power relative to other states. [ ] in practice, increasing spending on the pursuit of some values invariably means reducing spending on the pursuit of others. in a world where most states are not "great powers," the scope of security politics is richer and much more nuanced than presented by ir theories. the question of "how much security" has not been addressed at great length in the health security literature. the literature has broadly operated on the assumption that should health-related issues be "securitized" successfully, they will get the resources needed, which is in line with traditional security thinking on the issue. the scale of resources committed to addressing health crises, however, has so far been decided on an ad hoc basis, primarily by donors (public or private), and has often reflected the perceived proximity or scale of a health threat to national security as argued by rushton. [ ] thus, for example, a recent round of replenishment for the global fund to fight hiv/aids, tuberculosis and malaria saw donors pledge nearly $ billion. [ ] these diseases carry a similar burden of morbidity and mortality as some noncommunicable diseases, which have not received nowhere near as much funding. [ , [ ] [ ] [ ] [ ] [ ] nuclear defense spending in the uk and us, for example, far outweighs pandemic-preparedness spending, as highlighted by the current coronavirus pandemic. further analysis of the theory and practice of framing health security challenges is therefore urgently needed, with attention drawn specifically to existential threats facing individuals and communities. threats to security are traditionally defined as being external to the state, predetermined by the anarchic structure of the international system, and military in nature. [ ] the sharp decline in violent interstate conflicts and conflict-related deaths, however, as noted by the human security report project, [ ] threatens to deprive these studies of an object. does this mean, then that states and people are secure? one could hardly say so. with the majority of conflicts taking place within states and involving at least one nonstate armed group, [ , ] (with the intensification of violence against civilians, increasing intractability of conflicts and the spread of violent conflict to middle-income countries (iraq, syria, ukraine), assumptions about the nature and causes of conflict are continuously being challenged. [ ] the human cost of these conflicts is currently born extensively by civilians. [ ] in addition to conflict, people across the world lead daily battles for survival against disease, poverty, malnutrition, environmental degradation, climate change, lack of access to clean water, safe food, basic health services, against political oppression, gender-based violence, and so on. in this context, baldwin's argument that there is no reason to limit the concept of security to narrow, vague references at the expense of referring to practical threats that are comported with common usage, [ ] is particularly relevant. the health security literature has broadly kept in line with traditional security approaches on this question as well, by focusing analysis primarily on issues with a crossborder impact on national security, which has led to an overall narrow focus on health-related causes of insecurity-namely, emerging and re-emerging infectious diseases (erids) and bioterrorism. [ , , , ] some scholars have acknowledged that this focus is too narrow, proposing the inclusion of other issues such as internal state instability and illicit activities and an increased engagement of health security with public health and not just with the concerns raised by the foreign policy and security communities. [ ] this, however, is only a marginal broadening of the agenda, which fails to engage with two central questions-the protection of individuals and communities from danger, hazard and risk; and the much more complex question of whether security policy is just about negative security "security from" or whether consideration should be given to positive security as "security to." [ ] mcsweeney also talks about the importance of considering "structural" threats, namely, the unintended consequences of social action [ ] -the structure of the global economy, the pattern of power relations and dependencies within it, the profound influence of the food, tobacco and alcohol industry on government policy, gender inequality, levels of relative and absolute poverty, income inequality, etc. this is not to say that the health security literature is not cognizant of these, just that they have not been explored systematically and in sufficient depth, because too much attention has often been focused on dealing with acute threats. sovereignty grants states legitimate monopoly over the use of violence. employing the sovereign authority of states to respond to security problems is usually synonymous with the threat or use of military force or other types of coercive action. baldwin argues that the "specification of this dimension of security is especially important in discussions of international politics" and expresses concern that tendencies to define the field entirely in terms of the threat and use of military force "can prejudice discussion to favor of military solutions to security problems." [ ] improving and securing health, for example cannot be achieved by military means, even though military personnel and logistics can and have been utilized in emergency responses. pursuing security through nonmilitary means requires a human-centered focus and cooperative approach, where states engage not only with each other but also with a broad spectrum of nonstate actors. in security politics the state is increasingly becoming one actor among many, but with a key facilitating function in delivering security to individuals and communities. responses to health security challenges involve a broad spectrum of public and private actors, including intergovernmental organizations, inter-agency cooperation, civil society organizations, philanthropic foundations, corporate actors, etc.making for a complex governance architecture and a dynamic combination of various means and resources. the role of this panoply of actors has been explored in the context of global health governance, [ ] [ ] [ ] but not sufficiently so in the context of security politics, where the dynamics of governance interactions are distorted. in addition, promoting and improving health requires investment in infrastructure, education, knowledge development, in lifting people out of poverty, enhancing food and environmental security, all of which require concerted, cooperative efforts. this is a different model of thinking about security politics and appropriate security policy, compared with the zero-sum game, military, confrontational approaches proposed by mainstream security studies. some analysts promote the concept of "cooperative security," [ , [ ] [ ] [ ] premised on the changing nature of security threats as well as changing practices of security governance. this is an emerging fields of security analysis on which health security studies ought to draw more extensively. even though the assumption that security ought to be pursued at any cost is at the heart of traditional thinking about security politics, such conceptualization is unrealistic in most situations. as baldwin points out-"costs always matter." [ ] there are virtually no instances in practice where no restrictions on the means and costs of responding to a threat to security are in place, nor where other values are not competing for or having to be sacrificed in the distribution of scarce resources. this is not a question that has been examined in great detail either in mainstream security studies or in the health security literature, suggesting that analysts have adopted the traditional, exceptionalist frame of thinking about security, whereby a successful "securitizing move," automatically guarantees the availability of "sufficient" funds and resources to address security threats. addressing threats to security stemming from ill-health requires resources that go beyond the cost of medicines, as has become apparent through campaigns dealing with the spread of hiv/aids, tuberculosis, malaria, the fight against polio, and recent infectious disease crises-ebola, zika, and the covid- pandemic. the global health security agenda launched in , by the united states together with other states, who, the food and agricultural organisation and the world organisation for animal health, is one such attempt to promote activities aimed at strengthening "core capacities… of public health systems needed to protect global health security." [ ] analysis of the relative cost of security through the improvement of health and the alleviation of existential threats through the strengthening of health systems can be of particular importance in setting out domestic and global security priorities, but also in raising the required funds. cost is in many situations an inhibiting factor in pursuing particular interventions, despite evidence of the need for the latter. it should therefore always be a significant consideration in any health security policy analysis. mainstream international relations theories do not make a significant distinction between long-, medium-, and short-term security goals. their atemporal approach to security is premised on the assumption that the causes of conflict and insecurity do not change over time, due to the unchanging character of the anarchic international system. [ ] ahistoric realist and neorealist analysis seeks to justify the perpetual need to invest in military resources. in his brief discussion of this aspect of security, baldwin warns that short-term security politics often respond to an immediate threat, but a longer-term strategy for security may well conflict with the short-term approach. [ ] the existing health security literature does not tend to explore medium and long-term policy horizons, despite the pertinence of such temporal considerations to a broader view of health security. the health security literature has mainly taken an interest in current crisis [ , , [ ] [ ] [ ] with the aim of understanding the politics and institutions involved in the responses to these. and while such analysis is important and relevant, conclusions often point toward the need for a medium and long-term planning and investment. improvements in overall health security require much more than pandemic preparedness measures, including investment in the development of healthcare infrastructure, health systems strengthening, training of medical personnel. addressing the root causes of noncommunicable diseases, for example, may not be possible in the short-term, as they necessitate regulation and preventive action, which takes time to negotiate and implement as well as longer term planning and infrastructure investment. thinking about health security in differentiated time frames, therefore, could allow for a broader range of goals to be pursued, for more effective distribution of resources between acute and long-term needs and for pursuing goals of prevention, while also providing care where needed. baldwin's concept of security provides a structured and comprehensive framework for thinking about health security. it promotes systematic thinking about the assumptions and practice of health security politics that is not confined by the rigid ontologies of traditional security paradigms, but is open, flexible, and practice oriented. this conceptual framework enables the combination of rich empirical insight from existing studies of health security with a broader spectrum of approaches to security studies, to not only enhance understanding of political dynamics, but to also generate pragmatic policy options, accommodating of normative considerations. this section sets out new parameters for health security analysis that go beyond the constraints of traditional security studies. these require further analysis of practice and engagement with alternative security frameworks to inform health security policy on how best to address persistent criticisms and shortcomings. baldwin's guiding questions are grouped in three categories-ontological, normative and material considerations, and discussed in turn. concerns about the security of individuals have continuously been embodied in new international legal norms and made part of the global policy agenda over the course of the last few decades. the post-cold war years "exposed the fragility of the state in the face of complex forces within it and of trans-state limitations on its practical sovereignty outside it." [ ] instances of conflict, civil strife, political instability, state fragility, and now of the covid- pandemic are reminders that states are not always able or willing to guarantee the security of their citizens. the dominant view of security as a state-centric concept has been presented by its proponents "not as an option, a choice, but as the only one which is valid and rel-evant… [but] the assumption of security studies which ignores the human dimension is contradicted by the practical dependence of policy-makers and theorists alike on the human individual as the ultimate referent, or subject of security," argues mcsweeney. [ ] the argument in favor of foregrounding the security of individuals and communities in conceptual and theoretical debates is supported by practice. its relevance is particularly obvious in the context of (ill)health, which is probably one of the most prominent existential threats to humans, alongside environmental and food security. if the survival of individuals is not safeguarded, the survival of social structures and institutions loses its significance. contextualizing the security of individuals and groups in relation to and within state security is an area of security analysis that needs further attention in a changing landscape of political conflict-examples include the health security of populations in the context of civil war, failed or fragile states, [ ] [ ] [ ] or the provision of health-services in territories held by nonstate groups, e.g., rebels, guerrilla groups, isis; or the security of women and girl refugees fleeing conflict. [ , ] empirical evidence needs to be brought to bear on understandings of security politics in general and health security in particular. in addition to analyzing the relationship between individual, group, and state security, attention needs to further focus on the "providers" of security, which increasingly include specialized nongovernmental organizations, public-private partnerships, philanthropic foundations, multilateral agencies, and others. it has been assumed that this dynamic governance architecture is still under the control of sovereign governments, but there is little evidence to support that, particularly in contexts of conflict, fragile or failing states such as syria, afghanistan, yemen, south sudan. rushton and williams' "partnerships and foundations in global health governance," [ ] harman's "global health governance," and [ ] jeremy youde's "private actors, global health and learning the lessons of history" [ ] are useful starting points in outlining the architecture of health governance, but further analysis is needed to reflect on the idiosyncrasies of security-focused governance and politics. gjorv ( ) advocates the need to adopt a multiactor security model to explore the patterns of security-related governance, which she argues is prompted not only by normative considerations, but is a reflection of the empirical realities facing security practitioners, illustrating her argument with two examples civilmilitary operations and climate change in the arctic. [ ] baldwin's conceptualization of security demonstrates that restrictions on the referent object of security are superficial. when health-related risks and challenges pose an existential danger, they need to be considered as security risks, in recognition that individual and community security is as relevant a consideration to state security and vice versa. health-related existential threats to individuals and communities are further exacerbated by poverty, political instability, state fragility, conflict, and civil strife. but since state security can both determine and be determined by the security of individuals and communities, and since there are other actors involved who impact or are impacted by such insecurities, a more comprehensive understanding of the politics and frameworks of health security policy making is urgently needed. despite traditional theories of international relations discounting normative considerations in matters of security and national security, such considerations are always present. as discussed earlier, adopting a narrow state-centric, militaristic view of security is both an option and a normative choice, and not the only possible or valid one. this is the premise of much critique from critical security studies, as illustrated by works such as krause and williams, [ ] barkawi and laffey, [ ] booth, [ ] peoples and vaughan-williams, [ ] sjoberg, [ ] wibben, [ ] and shepherd. [ ] some analysts are further advocating consideration of security in terms of both positive and negative security, where negative security aligns more with traditional notions of security as "security from," while positive security is seen as enabling and emancipatory-"security to." [ , , ] such a lens enables values such as human life, life in good health, life with dignity, to be placed at the center of security strategy and policy, which in turn demands that security politics become more inclusive, more protective, less focused on privileged views and experiences of security, more human-centric. framing security as a positive value creates space for considerations such as health system strengthening, the provision of primary care and universal health coverage, the prevention of noncommunicable diseases, to be given greater policy priority, which as analysts have argued would not only improve health outcomes overall, but could also strengthen health responses to acute crises. health is an important value on a global scale, as evidenced by the constitution of the who ( ), the alma ata declaration ( ), the international health regulations ( ), the sustainable development goals ( ), along with the intrinsic value of human life, which is the bedrock of all international human rights norms, treaties, and declarations. if life and good health are the values to be secured, however, state policies would have to go beyond seeking to protect individuals and populations from emerging and re-emerging infectious diseases and bioterrorism and take into account a broader spectrum of health-related existential threats to people. diseases posing significant risks to people in low-and middle-income countries include among others neglected tropical diseases (ntds) [ ] [ ] [ ] and noncommunicable diseases. ntds' burden of disease measured in dalys ranked these diseases fourth after lower respiratory infections, hiv/aids, and diarrheal diseases, preceding malaria, tb, and measles. [ ] "noncommunicable diseases (ncds) are the leading cause of death globally and one of the major challenges of the st century." [ ] an estimated % of all deaths globally in resulted from ncds, the world health organisation (who) reports. over the next years, ncds will cost more than usd trillion, pushing millions of people below the poverty line. [ ] much like other global problems, health insecurity disproportionately affects low-and middle-income countries, as well as the poorest and often most disadvantaged strata of societies in high-income countries. an infectious disease pandemic like covid- further worsens health outcomes by compacting morbidity, exponentially increasing mortality and creating a perfect storm even for the relatively well-resourced health systems in high income countries. securing health and well-being is an important goal in a dynamic portfolio of values that need to be protected. how much attention should be devoted to health overall, and to specific health concerns, or the needs of particular groups within this portfolio, are questions that needs to be examined further and in greater detail, drawing on studies of public health in individual states and across borders. the answer to the question "how much security" is also likely to vary over time. analysis of the relative threat posed by a given health issue to individual, community, and state security is a valid consideration for health security politics-using a structured framework to enable comparative analysis is central to health security analysis. due to the relatively high morbidity and mortality, the covid- pandemic has demonstrated that health threats can be elevated to almost absolute, primary status. actions taken to contain the pandemic have included social distancing measures, limiting travel, shutting down economies, governments promising to pay salaries, support private businesses, etc., which are measures that appear unthinkable in most other cases. in the midst of this crisis, however, it is important to remember that pandemics of such scale and scope are relatively rare and to use covid- more as an extreme example than a baseline one. contrary to traditional security approaches premised on the use of military means, health security (whether broadly or narrowly defined) requires the employment of nonviolent, cooperative measures-including investment, humanitarian aid, development assistance, multiactor cooperation, coordination, sharing of information and expertise, etc. as discussed previously, the cost of addressing health security problems is significant, due to the need to establish and support a functioning health system, to train and retain professional staff, to create infrastructure that facilitates the functioning of the health system, but the cost of inaction is high and puts lives at risk. the challenges posed by public health emergencies of international concern and pandemics can be exceptionally far-reaching and damagingglobally, locally, trans-locally, as illustrated by the current spread of the sars cov virus. the human cost of this pandemic has been unprecedented in recent history, the economic costs are yet to be calculated with more than a quarter of the global population in lockdown, international travel restricted and economies shrinking fast. in a world of scarce resources, the means for securing health and the cost of doing it are pertinent policy considerations, which need to be examined in conjunction with the opportunity cost of both not investing in health security and of investing in a different field. the short-termism and immediacy of conventional security politics is counter-productive in approaching problems such as anti-microbial resistance, noncommunicable diseases, maternal and infant mortality. even responses to public health emergencies of international concern, in the form of communicable disease outbreaks, have demonstrated the need to develop a systematic approach-including properly resourcing the work of the who, investing in health systems strengthening and infrastructure. the report of an independent review committee on the h n response noted that "the world is illprepared to respond… to a global, sustained, and threatening public health emergency" as health capacities were not on a path to timely, worldwide implementation. [ ] the international community collectively and states individually appear to have squandered the time since to prepare for the next global pandemic. the health systems in high-income countries are buckling under the weight of the covid pandemic. concerns are growing over its effects the pandemic will have on low-and middle-income countries. in the conclusion to their discussion of the global response to zika virus, gostin and hodge point out that the apathy and short-sightedness of the international community must change, as the consequences of fast-moving epidemics are comparable with humanitarian crises, climate change, and war. [ ] such analysis and current events clearly illustrate that planning has to include the short-, medium-, and long-term and might be more effectively organized at the global level, as states are better off responding together than individually. to sum up, this discussion of the dimensions of health security demonstrates that health security can be conceived of as focusing on the security of people, communities, and states, if we accept that health security politics are centered on the protection of the core values of life and life in good health. since health security is concerned with issues that both pose an existential threat to people and also threaten and destabilize communities, its significance ought to be ranked relatively high. health security politics need to be viewed both as being embedded within the existing normative context of human rights and as themselves promoting a range of valuesincluding dignity, respect, nondiscrimination, emancipation, and empowerment. the pursuit of health security requires material resources like any other type of security. part of the politics surrounding health challenges center on competition for attention and scarce resources. the resources required for the enhancement of health security can be significant, as they involve developing infrastructure, training health professionals, the delivery of care, ensuring the accessibility of medicines, disease prevention, health promotion, and strengthening health systems. [ ] conceptualizing health security in this way, calls for a more holistic approach to encompass both the important work done through responses to global health emergencies and the need for medium-and long-term policies, because in health, just like in strategic politics, prevention is always better than cure. thinking about health security in a systematic way simultaneously highlights the idiosyncrasy of the health security field compared with other fields of security politics and demonstrates the interconnectedness and overlaps between them. baldwin's concept of security provides a guiding framework, a structured conceptualization through which to rethink the way in which health security has been imagined. the flexibility of ontological assumptions that it provides opens possibilities for health security studies to connect with contemporary security paradigms, defying the stereotypes, and constraints of traditional thinking about security. at the very least, it provides a structured framework that allows for comparative analysis of competing accounts of security politics with diverse paradigmatic assumptions. the framework is able to accommodate not just conceptual debate but observations of and reflections on practice. this article sought to contribute to debates about conceptualizing health security and understanding health security politics. it set out to challenge the use of traditional security paradigms, which obscure the significance of public health threats to individual and community security and well-being. the current covid- pandemic has brought these issues to the fore with a much sharper focus than previous public health emergencies of international concern. the brief overview of the different denominations of health security demonstrated that the grounding of existing analysis in securitization theory and constructivist thought has been driven in part by the desire to validate the claim that health-related challenges were indeed relevant security concerns, and in part by the need to fit within existing debates. overall, as has been demonstrated, health security analysis has remained predominantly anchored to the securitization approach, despite critiques levied at the copenhagen school by critical and feminist scholars. [ ] [ ] [ ] health security analysis has only marginally engaged with related bodies of work in the fields of foreign policy, human security or with alternative security paradigms, which has limited the field's dynamism, critical edge, and ability to influence policy debates. this article applied baldwin's framework of the concept of security to existing conceptual and empirical studies of health security to demonstrate how narrowly health security has been conceptualized and how much more analysis is needed for a better understanding of this complex field. traditional security analysis is broadly inhospitable to claims that health issues are a relevant security consideration, leading some analysts to reject the relevance of health to strategic security instead of questioning whether the way that security is framed and defined is still relevant to political and strategic realities and practice. baldwin's framework helps liberate health security analysis from the dogmatic assumptions of traditional security theories, while at the same time providing a structure for rigorous, comprehensive and comparable conceptual debate. experimenting with novel thinking about the ontological, normative and material considerations in health security can help push the boundaries not only of the health security field, but of security studies overall. particular questions for further research emerge-e.g., about the relationship between individual, community and state security, about the way in which resources are allocated to specific fields of security politics, about the differences in short-, medium-, and long-term planning in health security politics, about ways in which to evaluate the relative importance of competing security challenges, the relationship between perceptions and indicators, and so on. the exploration of these questions, based on a clear, explicitly defined concept of health security will promote more systematic thinking about security politics that is open, flexible, and practice oriented. taking a broader, more holistic and historically grounded approach to understanding the politics of health and security brings its own set of challenges. a comprehensive rather than parsimonious way of thinking would inevitably complicate analysis, as it incorporates more variables and tries to capture more, not less of the political and social complexities of security policymaking. questions about normativity and ethics need to be considered. drawing on knowledge across disciplinary borders is rarely unproblematic, as ontological, epistemological, and methodological differences may hinder multidisciplinary dialog. none of these difficulties, however, are insurmountable, as demonstrated by novel approaches to security studies, on which health security analysis ought to build. the pressing needs to rethink the dimensions of health security has regretfully been validated by the unfolding covid- pandemic. writing in the midst of this crisis, it is difficult to assess what the implications of this pandemic would be for societies, economies, health systems. the issues that the pandemic is bringing to the fore, however, are not new. academics have grappled with and tried to draw attention to some of these for at least the last years. [ ] sars cov , the virus that causes covid- , is a health security threat-make no mistake about it. this virus poses an existential risk to humansit threatens individuals, but impacts on communities and on almost every aspect of societal life-family life, social relations and activities, culture, education, the economy, government. governments around the world are using an unprecedented spectrum of measures to reduce morbidity and mortality, previously unseen in peacetime. the who has repeatedly noted that the response to the pandemic would be most effective if states work together in a spirit of cooperation, solidarity, and care. states need people, businesses (including private health care providers) and voluntary organizations to support the pandemic response, which is an illustration of multiactor security politics coordinated by governments and intergovernmental organizations. there is no doubt that this pandemic will bring about change-the extent and nature of the change is 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of urban conflict in iraq disease and security-natural plagues and biological weapons in east asia identity and interests: a sociology of international relations secur. hum. rights international theory: positivism and beyond south sudan conflict: violence against healthcare conflict survival critical security studies: concepts and strategies critical security studies: an introduction gender and international security-feminist perspectives feminist security studies-a narrative approach critical approaches to security-an introduction to theories and methods world health organisation, noncommunicable diseases country profiles , world health organisation the global economic burden of non-communicable diseases key: cord- -idflfwpb authors: alcover, carlos-maría; rodríguez, fernando; pastor, yolanda; thomas, helena; rey, mayelin; del barrio, josé luis title: group membership and social and personal identities as psychosocial coping resources to psychological consequences of the covid- confinement date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: idflfwpb the confinement imposed by measures to deal with the covid- pandemic may in the short and medium term have psychological and psychosocial consequences affecting the well-being and mental health of individuals. this study aims to explore the role played by group membership and social and personal identities as coping resources to face the experience of the covid- confinement and radical disruption of social, work, family and personal life in a sample of people who have experienced a month of strict confinement in the region of madrid. our results show that identity-resources (membership continuity/new group memberships, and personal identity strength) are positively related to process-resources (social support and perceived personal control), and that both are related to better perceived mental health, lower levels of anxiety and depression, and higher well-being (life satisfaction and resilience) during confinement. these results, in addition to providing relevant information about the psychological consequences of this experience, constitute a solid basis for the design of psychosocial interventions based on group memberships and social identity as coping resources. the accelerated expansion of covid- in the early months of forced governments to enact extraordinary and emergency measures of social distancing to deal with the pandemic. as a consequence, millions of people were suddenly isolated and confined to their households. in march , in just one week large cities such as milan, madrid or new york underwent rigid limitations on mobility and going out on the street, attending non-essential work and normal activities of daily life were forbidden. in the following days, the number of people infected and dead from covid- increased in fairly fast progression. overflowing hospitals, intensive care units at risk of collapse, overwhelmed health authorities and shortages of health resources to protect health professionals and citizens, generated a state of alarm unknown to current generations in developed countries. investigating and understanding how people dealt with a situation without referents is essential to identify resources that can be useful in an emergent and global crisis. there are antecedents of pandemic situations related to contagious diseases (i.e., the epidemics of sars - , the pandemic h n , or the ebola virus disease epidemic - ) [ ] , natural disasters and humanitarian crises caused by war conflicts. however, the scopes, large-scale and sudden nature of the covid- pandemic in a globalized world, make it an unprecedented experience for most of humanity. consequently, we need data that sheds light on the mechanisms and processes that people mobilize and develop to coping experiences that, directly and vicariously, dramatically affect their lives and, eventually, their physical and mental health. disaster research pointed out the importance of going beyond psychological coping approaches. thus, a perspective that considers coping as a social process includes a collective dimension, an experience-based dimension, and a local dimension, highlighting resources such as social capital and community resilience [ ] . social identity theory (sit) [ ] argues that in any social context people define themselves from their group membership, which means define their self in terms of social identity. if the multiple groups that define the self "provide a person with stability, meaning, purpose, and direction, then this will typically have positive implications for that individual's mental health" ( [ ] , p. ). extensive research from the social cure approach [ ] has provided robust evidence on the importance of social factors, specifically of the curative role played by social integration and social support, for mental and physical health [ ] . based on these approaches, this study aims first, to explore the possible existence of significant differences in relation to several socio-demographic and occupational variables regarding group memberships, social and personal identities, social support and health and well-being factors during the covid- pandemic. and second, to explore the role played by group membership, social and personal identities and social support as coping resources to face the experience of the covid- confinement and radical disruption of social, work, family and personal life. to do this, it uses a sample of people who have experienced a month of strict confinement in the region of madrid. in mid-july, spain had the third most deaths proportionally to their covid- cases for population in the world ( . deaths for , population, behind belgium, . , and united kingdom, . ) [ ] ; and madrid was one of the european cities with the highest incidence of contagion ( per , population) and deaths ( per , population; people have died ( . % of deaths in spain), suffered between march and june . the rapid global expansion since the end of in wuhan, in the chinese province of huabei, of the coronavirus named covid- , led to the majority of the european governments decreeing confinement, quarantine and isolation measures in their own homes or in public dependencies (hospitals, hotels, ocean liners, etc.). these measures affected millions of people on a scale never previously known. confinement is considered a public health preventive measure to reduce the risk of disease transmission, and affects not only sick people, but also healthy or asymptomatic individuals. quarantine involves separating and restricting the movement of people who have potentially been exposed to the contagious disease to determine if they are ill or have symptoms; their goal is to reduce the risk that they could infect other people in their close or public social context. and isolation refers to the social separation of people who have already been diagnosed with the contagious disease, so that they are not in contact with non-sick people [ , ] . despite these differences between public health measures, the terms are often used interchangeably, and in practice people subjected to them by the authorities experience diverse thoughts and emotions due to the limitation or loss of freedom of movement, doubts or fear of being infected (themselves or their loved ones and acquaintances), the loss or reduction of interpersonal and social contact, the disruption of daily habits both at work and leisure, boredom, stigma, and uncertainty about the future [ , , ] . there is scientific evidence of the psychological and psychosocial consequences of the confinement, quarantine and isolation measures studied in recent infectious diseases, such as sars, n h , or ebola [ , , [ ] [ ] [ ] [ ] , and the current covid- in china [ ] . these consequences are usually related to problems of anxiety, negative affectivity, irritability, fear, frustration, panic, depression and other negative emotional reactions, leading to infected people experiencing stigma and suicidal ideation or intentions. in turn, these consequences can lead to other health problems, both physical and mental, and a reduction in the quantity and quality of sleep. overall, literature review suggests [ , ] that the psychological impact of quarantine and confinement is wide-ranging, substantial, detrimental, and can be long lasting, depending on how long it lasts; evidence shows that a longer quarantine is associated with poorer psychological outcomes. however, this evidence has been obtained basically from an individual perspective, or a clinical approach, and as far as we are aware, the role played by collective and social factors in the psychological consequences of confinement and quarantine has not been sufficiently investigated. the social world is the canvas where human lives are painted. given the social nature of human beings, group membership and high-quality social relationships are vital for health and well-being. social contact and belonging to many groups are fundamental and pervasive human motivations [ ] and shape the roots of personal and social identity. for decades, research has accumulated data and solid arguments that show an association between social relationships and health [ ] . social factors play a central role in shaping health outcomes, and its effects are similar and often larger than that of poor health habits [ ] . less socially isolated or more socially included people had better psychological and physical health and less likely to die, at least prematurely [ ] . large meta-analytic data across , individuals, followed for an average of . years, was conclusive [ ] . individuals with adequate levels in two social factors associated with interpersonal relationships (social inclusion and social support) have a % greater likelihood of survival compared to those with poor or sparse social relationships. in an additional meta-analysis across independent studies in which several possible confounders were statistically controlled for, the weighted average effect sizes corresponded to an average of increased likelihood of mortality by % for social isolation, % for loneliness, and % for living alone [ ] . social inclusion occurs primarily through group membership. being a member of multiple groups satisfies the need to belong and, especially, provides identities [ ] . sit theory has demonstrated the central role of groups in building the social self. furthermore, individual self-concept includes both personal identity and group memberships, since people need others to validate their attitudes and behaviors [ ] . as tajfel [ ] has pointed out, social identity is the part of self-concept that derives from their awareness of belonging to social groups, as well as from the emotional and evaluative meaning associated with these multiple memberships. in sum, sit [ , ] has stressed that social behavior depends largely on the degree to which people see others sharing their social identities with them. internalized group memberships provide shared social identities. in turn, important psychological resources with implications for health are derived from shared social identities [ ] . these psychological resources primarily refer to perceptions of social connection and positive orientation to other people; a sense of meaning, purpose, self-worth through social connectedness and group life; social support exchange with people who define themselves in terms of shared social identity; and the development of a sense of control, efficacy and power [ , ] . extensive research has shown that one of the key resources that flow from shared social identities and group memberships are social support exchange opportunities, that is, interaction contexts for receiving, giving, and benefit from both social actions [ , , ] . empirical evidence in different contexts revealed that receiving social support was generally beneficial for psychosocial health [ ] [ ] [ ] [ ] [ ] , although there were some inconsistent results [ ] , and also that providing it might be even more beneficial than receiving it [ , ] . finally, although from the sit perspective traditionally personal and social identities are considered as the end points of a continuum [ ] , identity theory research has also analyzed the relationships of social identity with personal identity strength e.g., [ ] . from this perspective [ ] , people have different components of self-linked to each of the group role behavioral sets that they perform. the self, or personal identity, can be seen as a collection of identities that reflects the multiple roles that a person occupies in groups to which he/she belongs [ , ] . even if personal and social identity can be theorized and measured as separate, the fact of being strongly intertwined structures allows for the permeability of personal and social identities [ ] . furthermore, it has been suggested [ , ] "that a strong sense of 'me' flows from a strong sense of 'us'" ( [ ] , p. ). consistent with this idea, and in accordance with sit, research has shown [ , ] that a sense of shared social identity-as a result of group membership-has the ability to make group members feel capable and with personal control over their lives, through the development of a sense of agency, self-efficacy and power [ ] , with positive consequences for their health and well-being. in sum, these results show that social group memberships generate personal benefits through greater perceived personal control [ ] . the social cure approach proposed by [ , ] posits a three component model: social identity and identification factors (e.g., multiples identities, multiple group membership, social identity continuity, personal identity strength, and so on), process factors (e.g., group norms, social support, perceived discrimination, perceived personal control, and so on), and health and well-being factors (such as depression, anxiety, stress, resilience, affect, personal self-esteem, life satisfaction or general health) related with both antecedent factors (social identity and process) ( [ ] , see p. for an overview of the model). based on this model, our study explores whether: ( ) group memberships (specifically, membership continuity and new memberships) and personal identity strength, considered as identity-resources derived from group social identities, and ( ) social support (received and provided) and perceived personal control, considered as process-resources derived from the identity-resources, are related to well-being and psychological health in the confinement experience during the covid- pandemic. figure summarizes the proposed model. identity can be theorized and measured as separate, the fact of being strongly intertwined structures allows for the permeability of personal and social identities [ ] . furthermore, it has been suggested [ , ] "that a strong sense of 'me' flows from a strong sense of 'us'" ( [ ] , p. ). consistent with this idea, and in accordance with sit, research has shown [ , ] that a sense of shared social identity-as a result of group membership-has the ability to make group members feel capable and with personal control over their lives, through the development of a sense of agency, self-efficacy and power [ ] , with positive consequences for their health and well-being. in sum, these results show that social group memberships generate personal benefits through greater perceived personal control [ ] . the social cure approach proposed by [ , ] posits a three component model: social identity and identification factors (e.g., multiples identities, multiple group membership, social identity continuity, personal identity strength, and so on), process factors (e.g., group norms, social support, perceived discrimination, perceived personal control, and so on), and health and well-being factors (such as depression, anxiety, stress, resilience, affect, personal self-esteem, life satisfaction or general health) related with both antecedent factors (social identity and process) ( [ ] , see p. for an overview of the model). based on this model, our study explores whether: ( ) group memberships (specifically, membership continuity and new memberships) and personal identity strength, considered as identity-resources derived from group social identities, and ( ) social support (received and provided) and perceived personal control, considered as process-resources derived from the identity-resources, are related to well-being and psychological health in the confinement experience during the covid- pandemic. figure summarizes the proposed model. in the absence of previous studies from this theoretical perspective on the effects of confinement, and based on the propositions of the sit and the social cure model on the specified relationships between these constructs, as well as on the available empirical evidence on their combined effects on health, we formulated the following research questions: rq : how will group memberships be related to psychological health and well-being during the confinement experience? rq : how will the strength of personal identity be related to psychological health and wellbeing during the confinement experience? in the absence of previous studies from this theoretical perspective on the effects of confinement, and based on the propositions of the sit and the social cure model on the specified relationships between these constructs, as well as on the available empirical evidence on their combined effects on health, we formulated the following research questions: rq : how will group memberships be related to psychological health and well-being during the confinement experience? rq : how will the strength of personal identity be related to psychological health and well-being during the confinement experience? rq : how will social support received and social support provided be related to psychological health and well-being during the confinement experience? rq : how will perceived personal control be related to psychological health and well-being during the confinement experience? this study has been approved by the research ethics committee of universidad rey juan carlos (madrid, spain), record number , dated - - , and meets all ethical and legal standards applicable to research of this survey modality. the participants were inhabitants from the region of madrid, women ( . %) and men ( . %), mean age . years (sq = . , range = - ). the most frequent level of studies completed was a bachelor's degree ( . %), followed by a master's degree ( . %) and a high school diploma ( . %). participants completed a questionnaire via the qualtrics platform, that included socio-demographical data and self-report measures related to the study variables. the socio-demographic and occupational variables were evaluated by means of ad hoc items, related to age, gender, current occupational status, educational level, maintaining or not a couple relationship during confinement, having or not having children, belonging to a covid- risk group, type of work during confinement, and being or not a health professional. this variable was measured with the exeter identity transition scales (exits) [ ] . the scale has two dimensions: membership (or social identity) continuity and new membership. membership continuity: four items, scored on a -point likert response format ranging from (completely disagree) to (completely agree). the time frame is before confinement. an example item is: "before the confinement start: . . . i belonged to many different groups". new memberships: four items, with the same -point likert response format. "during the period of confinement: . . . i've joined one or more new groups" is an example item. the internal consistency was adequate for both dimensions (α = . and α = . , respectively). higher scores indicated higher levels of group membership. this scale [ ] consisted of five items scored on a -point likert response format ( = completely disagree, = completely agree). item example, "i know what i want in life", and the reliability was good. the internal consistency was α = . . this is a short version of a -item measure originally developed by [ ] . the measure incorporates items designed two subscales, received social support (e.g., "i know what i want in life") and provided social support (e.g., "get the emotional support you need from others"), with -items each one and with -point likert format, from (completely disagree) to (completely agree). both subscales showed high reliability (α = . and α = . , respectively). this is measured with the scale developed by [ ] ; items scored on a -point likert response format ( = completely disagree, = completely agree). the alpha coefficient was α = . . an example item is: "i feel in control of my life". the instrument used was the generalized anxiety disorder- (gad- ) [ ] in its spanish adaptation [ ] . this widely used test consists of seven items, in which the subject must respond according to his agreement with one of the four possible alternatives, thinking about what happened during the last week, = never; = several days; = more than half the days; = almost every day. an example item statement is: "feeling nervous, anxious or on edge". higher scores indicated higher levels of anxiety symptoms. the reliability was α = . . we used the patient health questionnaire-depression scale (phq- ) [ ] adapted to spanish [ ] . nine items scored on a -point likert response format ( = never; = several days; = more than half the days; = almost every day) to answer about the personal situation in the last week. an example item statement is: "little interest or pleasure in doing things". higher scores indicated higher levels of depressive symptoms. cronbach's alpha was α = . . brief resilience scale (brs) [ ] : six items with a likert scale scored on a -point likert response format ( = completely disagree to = completely agree) to answers for items such as "i tend to bounce back quickly after hard times". the internal consistency was α = . . this parameter was measured by the satisfaction with the life scale (swls) [ ] , in its spanish version [ ] . this scale consisted of five items that were scored on a -point likert-type scale ( = completely disagree, = completely agree). an item example is: "the kind of life i lead is similar to the kind of life i always dreamed of leading". cronbach's alpha was α = . . two measures developed by [ ] were used. the mental health one has four items, with a dichotomous response (yes/no) and people should think about what happened last week to answer questions like: "have you enjoyed life most of the time?" cronbach's alpha was α = . . the questions of the perceived physical health scale have a different answer format for each of the three items, and score was calculated as an index. an example item is "do you often have pain problems?" in spain, population lockdown took effect at : on sunday, march . due to the isolation circumstances in which the research team conducted this study, a virtual snowball sampling was used. for the sampling to produce significant monitoring data, access to subjects was ensured from six personal and two professional networks. participants completed a self-report questionnaire on a qualtrics online platform which they accessed via a web link, after being informed of the study and giving their consent to be included in it. the data collection was carried out from to april , after one month of confinement. for statistical procedures, statistical package for social sciences (spss) v. (ibm corp., armonk, ny, usa) was used. the kolmogorov-smirnov normality test was used to verify data distribution. results for normality test failed, and therefore nonparametric contrast tests were conducted. to verify the relation between identity, social support and well-being measures, spearman's rank correlation coefficient test was used. to assess differences on these non-normally distributed continuous variables among socio-demographic characteristic groups, analyses of covariate were conducted using mann-whitney u test for independently sampled groups and kruskal-wallis h test for or more groups using post-hoc dunn test with bonferroni adjustment. mann-whitney u tests and kruskal-wallis tests results are expressed as median (range). the socio-demographic characteristics of our study sample are described in table . firstly, we offer the most significant differences in relation to gender ( table ) , age (table ) , educational level (table ) , working and occupational status (table ) , people who were (or not) in a relationship in confinement (table ) , and membership of a covid- risk group. table . descriptives (md (iqr)) and post-hoc differences by age group. regarding gender differences (table ) , the mann-whitney test indicated that the provided social support was greater for females than for males, although females also showed higher values for anxiety and depression. males scored higher in resilience and physical health. with regard to age group differences, the kruskal-wallis h test performed showed a significant difference in new memberships (χ ( , n = ) = . , p = . ). the most significant post hoc results showed (table ) worse results for the younger age groups (less than years). notably, group ( - years old) presented worse general indicators, with higher levels of anxiety and depression and lower levels of mental health than participants over , and lower levels of perceived physical health, resilience and life satisfaction than those in group ( - years). similarly, group ( - years) presented greater anxiety and worse mental health than the participants over years old, the latter result also obtained by those of - years old. dunn-bonferroni post hoc test. only significant differences between groups appear (p < . ). table . descriptives (md (iqr)) of the variables with significant differences for "having or not a relationship during confinement" and "having or not children". in reference to the educational level, the kruskal-wallis h test reported significant differences between groups in continuity in membership (χ ( , n = ) = . , p = . ) and new memberships (χ ( , n = ) = - , p = . ). as can be seen in table , participants with higher levels of education showed better general indicators. specifically, those with doctoral degrees expressed lower levels of anxiety and depression than high school graduates, and higher levels of mental health and resilience than those with primary education. while those with a master's degree reported greater group membership continuity than high school graduates, and more new group memberships than those with a bachelor's degree. as shown in table , people who were working during the period of confinement (teleworking or face-to-face) presented greater membership continuity, life satisfaction, resilience and mental health than people who didn't work (temporary suspension of contract, sick leave, erte or inactivity due to confinement). moreover, people who didn't work expressed higher levels of depression that people who were in working in confinement. regarding occupational status, the most significant results showed that retirees experienced lower levels of anxiety and depression than part-time workers and students, better mental health than part-time workers, the unemployed, covid- unemployed, and students, and also less depression than the latter three groups. in addition, students showed less resilience than retirees, worse mental health and greater depression than self-employed and full-time workers, and greater anxiety than the latter. the results shown by the students are consistent with those already mentioned for the younger age groups (table ). compared to other professionals (o), health professionals (hp) reported that they developed more new group memberships, showed greater personal identity strength, provided more social support, and had more perceived personal control. the results in table show that people who were in a relationship in confinement showed lower levels of depression and better mental health. in turn, people with children showed less anxiety and depression, and also displayed higher personal identity strength, life satisfaction, resilience, mental health and physical health. finally, people who belonged to a covid- risk group only reported worse perceived physical health (mdn = . , iqr = . - . ) than those who did not belonged (mdn = . , iqr = . - . ), u = . , p = . ). as shown in table , maintenance of memberships before quarantine was correlated with the building of new ones during quarantine (ρ = . , p < . ). membership continuity was associated with identity strength (ρ = . , p < . ), but new memberships were not correlated with it. meanwhile, received social support correlated with membership continuity (ρ = . , p < . ) and with personal identity strength (ρ = . , p < . ). and provided social support was positively associated with membership continuity (ρ = . , p < . ), new memberships (ρ = . , p < . ) and highly with personal identity strength (ρ = . , p < . ). moreover, perceptions of received and provided social support were strongly correlated (ρ = . , p < . ). spearman's rank correlation coefficients related to perceived control are also presented in table . personal identity strength showed a significant association (ρ = . , p < . ), and also received social support (ρ = . , p < . ) and provided social support (ρ = . , p < . ). correlations regarding relationships group and identity-resources measures and health and well-being perceptions are also shown in table . membership continuity was correlated with resilience (ρ = . , p < . ). personal identity strength was positively associated with resilience (ρ = . , p < . ), life satisfaction (ρ = . , p < . ), mental health (ρ = . , p < . ) and perceived physical health (ρ = . , p < . ) and negatively with anxiety (ρ = − . , p < . ) and depression (ρ = − . , p < . ). new identities showed no associations with well-being. meanwhile, received social support was positively associated with resilience (ρ = . , p < . ), life satisfaction (ρ = . , p < . ), mental health (ρ = . , p < . ) and perceived physical health (ρ = . , p < . ) and negatively with anxiety (ρ = − . , p < . ) and depression (ρ = − . , p < . ). whereas provided social support was positively associated with resilience (ρ = . , p < . ), life satisfaction (ρ = . , p < . ), mental health (ρ = . , p < . ) and perceived physical health (ρ = . , p < . ) and negatively with anxiety (ρ = − . , p < . ). lastly, perceived control was positively associated with resilience (ρ = . , p < . ), strongly with life satisfaction (ρ = . , p < . ), mental health (ρ = . , p < . ) and perceived physical health (ρ = . , p < . ) and negatively with anxiety (ρ = − . , p < . ) and depression (ρ = − . , p < . ). we conducted additional analysis in order to delve deeper into the relationships between received and provided social support during the pandemic, perceived personal control and personal identity strength and the different health and well-being factors. to this end, these variables were recoded in three clusters or groups as follows: level or low (equal to or below the th percentile), level or medium (above the th and below the th percentile), and level or high (equal to or above the th percentile). to study the differences between the three clusters of each variable, the kruskal-wallis h test and the dunn-bonferroni post hoc test were performed. with respect to differences between levels of received social support, the kruskal-wallis h test showed significant differences in life satisfaction (χ ( , n = ) = . , p < . ), depression (χ ( , n = ) = . , p = . ), mental health (χ ( , n = ) = . , p < . ), resilience (χ ( , n = ) = . , p = . ) and physical health (χ ( , n = ) = . , p < . ). the results of the dunn-bonferroni post hoc test pointed out that people who experienced a high level of received social support had greater mental health (p < . ), and physical health (p < . ) than those who had a low or medium level. they also expressed greater resilience (p < . ) and lower depression (p < . ) than the low-level group. in addition, the medium group had greater life satisfaction (p < . ) than those with low level. as for the differences in the levels of provided social support, our data reported significant differences in life satisfaction (χ ( , n = ) = . , p < . ), mental health (χ ( , n = ) = . , p = . ), resilience (χ ( , n = ) = . , p < . ) and physical health (χ ( , n = ) = . , p = . ). the dunn-bonferroni post hoc test showed that those with a high level of provided social support had greater life satisfaction (p < . ), mental health (p < . ), resilience (p < . ) and physical health (p < . ) than the group of low level. medium level group presented greater life satisfaction (p < . ) and resilience (p < . ) than low level group. with regard to the differences between the three groups of perceived personal control, the performed test reported significant differences in life satisfaction (χ ( , n = ) = . , p < . ), anxiety (χ ( , n = ) = . , p < . ), depression (χ ( , n = ) = . , p < . ), mental health (χ ( , n = ) = . , p < . ), resilience (χ ( , n = ) = . , p < . ), and physical health (χ ( , n = ) = . , p < . ). the dunn-bonferroni post hoc test showed that those with a high level of perceived personal control had greater life satisfaction (p < . ), mental health (p < . ), resilience (p < . ) and physical health (p < . ), and lower levels of anxiety (p < . ) and depression (p < . ) than the group of low level. moreover, presented greater life satisfaction (p < . ), mental (p < . ) and physical (p < . ) health and lower depression (p < . ) than the group of medium level. in addition, the group of medium level showed greater life satisfaction (p < . ), mental health (p < . ), resilience (p < . ) and physical health (p < . ) and lower anxiety (p < . ) and depression (p < . ) levels than the group of low level. finally, attending to the differences between the levels of personal identity strength, the results indicated the existence of significant differences in life satisfaction (χ ( , n = ) = . , p < . ), depression (χ ( , n = ) = . , p = . ), mental health (χ ( , n = ) = . , p < . ), resilience (χ ( , n = ) = . , p < . ) and physical health (χ ( , n = ) = . , p = . ). the post hoc tests reported than those with high level of personal identity strength had greater life satisfaction (p < . ), resilience (p < . ), mental (p < . ) and physical health (p < . ) and lower depression (p = . ) than those belonging to the low group. also presented greater resilience (p = . ) than the medium level group. moreover, the medium level group had greater life satisfaction (p < . ) and mental health (p < ) than the low-level group. in relation to the first objective of our study, our preliminary results showed that women had poorer mental health (anxiety and depression) than men, who showed better physical health and greater resilience. prior evidence on gender differences in relation to the psychological consequences of quarantine was inconclusive, with some studies [ ] showing a greater negative psychological impact on women, while others [ , ] found no difference. our results did show a higher incidence in women, although it would be necessary to know the history of psychiatric illness in order to conclude that these worse mental health indicators were related to the experience of confinement. meanwhile, our data showed that women were providers of social support to a greater extent than men. this result was consistent with the evidence for women's greater ability to provide social support-as gender (femininity) not as sex [ ] ; however, by showing higher levels of depression than men, it appears that the social support exchanged between women, and that received from men, was not sufficient to buffer the negative effect of confinement stressors. this interpretation is consistent with the evidence suggesting [ ] that women are better providers of social support to men than men are to women. however, this result does not confirm the prediction [ ] that the modalities of social support (empathy, active coping assistance, and role modeling) provided by experientially similar others-i.e., women-be efficacious in alleviating the psychological impacts of stressors. regarding age groups, the worst mental health (anxiety and depression) and the lowest well-being (life satisfaction) of the - year-old group and the students can be highlighted. this result is also consistent with prior evidence; for instance [ ] found that the [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] year age group suffered the most negative psychological impact in a quarantine situation, and [ ] , in a study conducted in china in the context of covid- , have found that the younger population perceived more impacts of the epidemic outbreak (changes over living situations or emotional control), negative coping style and had higher level of psychological distress. the poorer mental health and lower life satisfaction of young people, as well as of students, can be explained by the disruption of their lifestyle by confinement, at an age where relationships and social contact are high valued. in addition, the economic effects of covid- on employment may further affect young people's precarious employment and career opportunities, increasing their frustration. regarding educational level, people with doctoral degree show greater continuity of membership and more new memberships than people with close educational levels (high school and bachelor's degrees), as well as better mental health, lower anxiety and depression, and greater resilience than those with primary education and elementary school degree. consistent with these results, there is broad evidence (e.g., [ , , ] ) that people with high (perceived) socio-economic status (assessed in terms of level of education) or with high (perceived) group status have more social capital and it is beneficial for their well-being and health. people who had a relationship and cared for children during confinement manifest better mental health and higher strength of identity, life satisfaction, resilience and physical health. data from china's population in the early stages of the covid- quarantine [ ] showed that unmarried people were more aware of the impacts of the epidemic outbreak and had a higher level of psychological distress. these data seem to indicate that affective and family relationships can play a buffering role of confinement stressors. the results also indicated that continuing to work (face-to-face or teleworking) was associated with better indicators of social identity and mental health compared with those who did not work for any reason. in this case, it appears that the potential stress from working under the conditions imposed by the pandemic was not experienced or added to the confinement stressors. rather, it can be interpreted that group membership continuity (i.e., identity continuity) facilitated by work activity is related to a perception of less life disruption, and consequently, to better mental health and greater resilience and vital satisfaction [ ] . it is also possible that downward social comparisons of people in working with those who lost their jobs or were infected by covid- , may have facilitated their perception of psychological well-being [ ] . regarding retirees, the results also seem to underline the importance of identity, as is the case for working people. in this regard, although they no longer worked, their mental health indicators were better (along with those of full-time employees) than those of most occupational groups. this interpretation is consistent with previous data [ , ] indicating that new group memberships and identification as a retiree play a protective role and has positive effects on well-being and mental health. as for our second objective and the four research questions that we asked, our results allow us to give a preliminary answer to all of them. identity-resources showed a significant relationship between them, so that membership continuity was associated with new memberships during confinement. this result may be relevant, as it indicates that in such a life disruptive experience the identities associated with group memberships were maintained and could facilitate new identities through memberships that were necessarily largely adopted without face-to-face contact. this result is consistent with sit's postulates [ , ] and self-categorization theory (sct) [ ] that the (cognitive) perception of group membership is sufficient to create a group identity. as sct posit [ , ] , group membership and social category-based self-conceptualization are motivated by uncertainty reduction [ ] . thus, contextual uncertainty created by confinement and the covid- pandemic could be reduced entering new groups, adopting new identities and by group action, although within the limits imposed by social distancing and quarantine measures. a significant relationship was also found between membership continuity and personal identity strength, which coincides with sit's approaches that defend the links between social identity and personal identity [ , ] and permeability of both [ ] . the correlation between the new memberships and personal identity strength was not significant, but this may be due to the relatively short time that has passed since the adoption of new group identities (less than a month), so it will be relevant to analyze whether this relationship is reinforced over time. in sum, our results show that participants had both identity-resources during the confinement, and it is important to check, as our model based on the social cure approach [ ] proposes, if they are related to process-resources and, especially, to well-being and health perceptions. with regards to social support, a significant relationship was found between support received and support provided. this result is relevant, because prior evidence indicates [ ] that both occur when the size of social network is large, which again is associated with group membership, since a positive relationship was found between continuity and social support received and given, and new membership and social support provided during confinement. our results are coincident with prior research founding that shared social identities and group memberships are social support exchange opportunities for receiving, giving, and benefit from both social actions [ , , ] . in addition, personal identity strength was positively related to received and provided social support and perceived personal control. in turn, both types of social support were significantly related to perceived personal control, which is consistent with the previous literature [ ] [ ] [ ] . thus, it can be concluded that social support exchange with people who define themselves in terms of shared social identity are related with the development of a sense of control, which constitute important psychological resources for people [ , ] . our model based on the social cure approach [ ] suggested that both types of social and personal resources (identity-resources and process-resources) would be related to perceived well-being and health. correlational analyses and, especially, additional analyses conducted clustering in low, medium and high levels of identity and process resources, confirm the relationships between strength of personal identity, social support received and provided, and perceived personal control and health and psychological well-being consequences experienced during the covid- pandemic. the clearest indicator of these relationships is resilience, since all resource variables, except for new memberships, are positively and significantly related to it. these results are reinforced by the significant differences found in the greater resilience of groups with high levels of social support received and provided, perceived personal control, and strength of personal identity in relation to groups with medium and low levels of these three resources. these results are consistent with previous evidence that identifies multiple group memberships [ ] , strength of personal identity [ ] , social support received [ ] , especially in people exposed to trauma [ ] , and perceptions of personal control [ ] as antecedents to resilience. overall, our results are aligned with the perspective that postulates social identity as a basis for resilience, both individual [ ] and collective resilience [ ] , and have important implications for the design of psychosocial interventions that foster group membership and participation, specially to coping with potential future confinement experiences in cases of new outbreaks of the covid- . for their part, anxiety experienced during confinement was less, perceived mental health was greater, and life satisfaction was higher for people who felt personal identity strength, received and provided social support, and perceived personal control. these results are also consistent with extensive prior evidence [ , [ ] [ ] [ ] , and are relevant for future interventions, as discussed below. similar results were found for depression, although in this case the social support provided was not significantly related. finally, people who pertained to the cluster of high levels of provided and received social support, personal identity strength, and perceived personal control experienced in general greater mental health and life satisfaction and better overall physical health than groups of medium and low level, which is also consistent with prior evidence [ , , ] . the main implications of our study concern the design of psychosocial interventions. for instance, the team of haslam et al. [ ] has successfully implemented a social intervention program labeled groups health that develops the social identity model of identity change (simic) [ ] , applied to life transitions as retirement. in a similar vein, our model proposal and the results obtained can be useful for the design of strategies and psychosocial interventions in the sense of strengthening social networks and the potential social support derived from them. given the strong link between social relations, support and mental health [ , ] , actions aimed at strengthening interpersonal relations and social networks through, for example, support groups, community initiatives or networks of people who share similar characteristics (of studies, profession, interests, etc.) [ ] , can be very effective in providing social coping and resilience resources that increase the personal resources of those who experience, for example, post-traumatic stress following confinement. interventions designed with the groups health model to address problems of social isolation or loneliness, stress, anxiety and depression have proven effective [ ] , so that its adaptation to address the potential psychological consequences of confinement appears promising. this proposal for group-based interventions is even more relevant if we take into account the warnings of health authorities regarding potential outbreaks of covid- in the coming months. this study was conducted with a non-probabilistic sample and using a measure of the study variables one month after the start of the confinement. consequently, only relationships between variables can be established, so our aim is for future studies to include a greater number of temporary measures with subsequent follow-ups in order to identify causal relationships between variables. in this sense, longitudinal studies may allow to test the potential mediating role of process-resources in the relationship between identity-processes and factors related to health and well-being [ ] . likewise, the participants were residents of the region of madrid and the sample size is relatively small, so the results cannot be generalized to the spanish population. however, given that madrid was one of the european regions where the covid- was most virulent, our results are relevant for understanding the experiences of citizens and their perceived levels of well-being and health in a situation of extreme alarm. future research, as well as potential interventions, should test whether resources based on social and personal identity and group membership, as well as the process resources provided by them (social support and perceived control), can play a protective (buffering) role for well-being and health in disruptive situations such as that triggered by the covid- pandemic. if future threats of virus outbreaks or similar health crises occur, this knowledge can be of great value and use in helping people to cope and overcome them with as little harm to their well-being and health as possible. in short: our results provide a first overall answer to our research questions: identity-resources and process-resources associated with them have positive relationships with the levels of well-being and health experienced during confinement. furthermore, as far as we know, this is the first time that the social cure model [ , ] is used in a sample of the spanish population, and our results may complement those obtained by other studies carried out in spain during the covid- pandemic (i.e., [ ] [ ] [ ] ). finally, our study may also contribute to the design of interventions based on this model, as we discussed in the prior section. infectious disease pandemic planning and response: incorporating decision analysis understandings of coping: a critical review of coping theories for disaster contexts the social identity theory of intergroup behavior social identity, health and well-being: an emerging agenda for applied psychology the new psychology of health. unlocking 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distress and psychic morbidity in spanish population funding: this research received no external funding. the authors declare no conflict of interest. key: cord- -zpzncgiv authors: galimberti, andrea; cena, hellas; campone, luca; ferri, emanuele; dell'agli, mario; sangiovanni, enrico; belingheri, michael; riva, michele augusto; casiraghi, maurizio; labra, massimo title: rethinking urban and food policies to improve citizens safety after covid- pandemic date: - - journal: front nutr doi: . /fnut. . sha: doc_id: cord_uid: zpzncgiv the ongoing pandemic caused by the coronavirus disease (covid- ) is literally changing the world. from december to date, more than million cases have been reported worldwide and global health institutions are acting to slow down the virus transmission and are looking for possible prevention strategies in case of a new outbreak. as in other endemic or pandemic phenomena, the issues mostly covered by scientific and media attention are related to the diagnostic and therapeutic approach of covid- . however, a still neglected issue regards the adoption of a more systemic approach considering the close connection among the infection, the environment, and human behaviors, including the role of diet and urban management. to shed light on this issue, we brought together a faculty group involving experts in environment and biodiversity, food safety, human nutrition, and behavior, bioprospecting, as well as medical doctors having a deep knowledge of the complex historical relationship between humanity and vector-borne infections. two main aspects emerged from the integrative overview of the current covid- pandemic: (i) the scientific community should start sharing social actions and policy advocacy based on the assumption that human health strongly depends upon a sustainable exploitation of natural resources in populated areas; (ii) the specific strategic role of the cities in developing sustainable food systems and promoting healthy dietary patterns. definitely, some priority issues should be addressed to achieve these goals, such as global efforts to increase food safety and security, which would benefit from urban and peri-urban agriculture enhancement, smallholder food producers support, and ecosystem services and local biodiversity maintenance. the ongoing pandemic caused by the coronavirus disease (covid- ) is literally changing the world. from december to date, more than million cases have been reported worldwide and global health institutions are acting to slow down the virus transmission and are looking for possible prevention strategies in case of a new outbreak. as in other endemic or pandemic phenomena, the issues mostly covered by scientific and media attention are related to the diagnostic and therapeutic approach of covid- . however, a still neglected issue regards the adoption of a more systemic approach considering the close connection among the infection, the environment, and human behaviors, including the role of diet and urban management. to shed light on this issue, we brought together a faculty group involving experts in environment and biodiversity, food safety, human nutrition, and behavior, bioprospecting, as well as medical doctors having a deep knowledge of the complex historical relationship between humanity and vector-borne infections. two main aspects emerged from the integrative overview of the current covid- pandemic: (i) the scientific community should start sharing social actions and policy advocacy based on the assumption that human health strongly depends upon a sustainable exploitation of natural resources in populated areas; (ii) the specific strategic role of the cities in developing sustainable food systems and promoting healthy dietary patterns. definitely, some priority issues should be addressed to achieve these goals, such as global efforts to increase food safety and security, which would benefit from urban and peri-urban agriculture enhancement, smallholder food producers support, and ecosystem services and local biodiversity maintenance. the ongoing pandemic caused by the coronavirus disease (covid- ) is literally changing the world ( , ) . from the first documented human patient in wuhan (hubei, people's republic of china) in december , on august , more than million cases have been reported worldwide, of which more than six million still active ( % in serious or critical conditions) and almost k deaths. who and other authorities soon realized that it was no longer possible to contain the virus spread, but only to slow down its transmission and try, at least, to reduce "pressure" on national health systems. as in other endemic or pandemic outbreaks, the issues mostly covered by scientific and media attention are related to the diagnostic and therapeutic approach of covid- contagion. however, greater consideration should be given to a systemic approach considering the close connection between this disease, the environment and human behaviors, in a framework of building a safer, more sustainable and healthier world ( ) . how is it possible that a virus from a chinese market has spread to other continents so quickly, penetrating the heart of cities and killing the weakest citizens? to shed light on this issue, we brought together a faculty group involving experts in environment and biodiversity, food safety, human nutrition, and behavior, biological activity of natural products as well as medical doctors having a deep knowledge of the complex historical relationship between humanity and vector-borne infections. we believe that unlike the pandemics of the past, the factors triggering the current spread of covid- outbreak, should be analyzed not only by scientists and politicians but also by societal stakeholders. many european countries most afflicted with covid- have started thinking ahead are now facing with the "phase two" of the covid- situation by operating the recovery of industrial and social activities keeping, at the same time, the infection spread as low as possible. in such a context, the linear science, which analyzes those biological variables dealing with the pathogen and its infectivity to find possible solutions [e.g., a vaccine or a therapy ( )], clashes with the "post-normal science" (psn) approach, for which, societal values (e.g., the right to freedom, economic needs, and relational aspects) claim their importance ( ) . pns is designed to deal with situations of uncertain facts, values in dispute, high stake and urgent decisions [( ); figure ]. pns should be operated together with responsible research and innovation (rri) tools (https://www.rri-tools.eu/aboutrri) that offer a broad set of strategies to address global challenges throughout the analysis of "real-world complexities' considering new scientific knowledge and technologies, but also the needs of different stakeholder categories. the contrast between these approaches to science is exerting some pressure on governments that even proposed solving the problem of covid- with autonomous strategies or hypothesized to reach a sort of herd immunity by sacrificing an entire generation of older people ( , ) . this situation demonstrates the lack of organization by the modern society to address complex global issues. our contribution aims at supporting the adoption of a pns response to covid- pandemic, also considering the geopolitical and social aspects which caused the dramatic susceptibility to such infection. for this reason, we aimed at better addressing two main concepts regarding covid- "effect" on cities and citizen-led community responses, to prevent future pandemic events. the first point to discuss is the unexpected permeability of cities to this virus and hypothesize how the spillover from wildlife of such a kind of pathogens can reach urban centers. this evaluation is of primary concern to better define suitable prevention strategies for limiting or blocking the current one and other future pandemic spreads. what characterizes covid- contagion, is that it fully took advantage of globalization facilities, enabling rapid spread of the virus across the world. generally, accurate controls are performed on goods transported worldwide but in case of novel pathogens (e.g., the covid- ) diagnostic options are very limited. moreover, when human mobility is a major factor in the spread of infectious diseases, we should acknowledge that screening measures adopted at airports or customs should be implemented ( ) . temperature screening alone may not be very effective as it may miss travelers incubating the disease or concealing fever during travel, or it may yield false positives (e.g., having fever of a different cause), therefore it should be accompanied by other health messages, questionnaires and data collection ( ) . a different scenario occurs for the trading of food commodities for which strict regulations about quality and safety impose the adoption of analytical tools and innovation technologies to prevent the spread of foodborne pathogens or other contaminants ( , ) . in most cases, food quality evaluation is based on bioindicators, both at chemical and microbiological level ( , ) . most diagnostic techniques allow to characterize the internal microbiome and virome ( ) ( ) ( ) ( ) . considering covid- , what can be said with certainty is that such controls did not occur in the wuhan market where the virus started its incredible global spread. this situation further remarks the concept that pandemics are strictly linked to insufficient or absent food safety assessment and disease prevention protocols (e.g., as happening every time ebola viruses outbreak in central africa). it is necessary to remark that the food regulations across countries vary and the quality standards of the same food items produced in different countries are not the same ( , ). the current covid- pandemic, perhaps more than others, highlights that it is necessary to align food security protocols on a global scale since country specific inadequacies may cause serious global consequences. therefore, we believe that to prevent future pandemic outbreaks it is more and more important to consider issues arising from the establishment of supranational risk-governance systems. these typically operate in a framework of compromise between the local governance and local producers needs and the global safety for human health. safety is a priority for all the stakeholders associated with the entire food supply-chain. moreover, after the covid- emergency, it is desirable that citizens enhance its awareness toward the topic of food control and the concept of food safety will acquire a stronger social meaning based on "shared values, beliefs and norms that affect human mindset and behavior" ( ) . consumers' behavior and choices will help modify food supply-chains safety to prevent zoonoses and reduce other risks for humans. ( )] provides a framework to map systems uncertainty against decision stakes. global citizenship is based on rights to be actively involved in debates, responsibility, shared decisions (following careful risk evaluation), and actions to control and implement shared strategies. with regard to covid- , we know that a bat species and/or the malayan pangolin have been found to be likely reservoir hosts for the virus; however, the definitive identity of any intermediate host that might have facilitated spillover to humans is still unknown ( , ) . overall, the identification of the vector has a relatively important value. the central point is that the unceasing exploitation of wildlife and habitat has dramatically increased the risk of exposure to zoonotic diseases, as already and sadly demonstrated for example by hiv, ebola and h n ( ) . but how calculating the risk of these phenomena? are stakeholders and citizens aware of the risks? these elements are fundamental for a pns discussion that is necessary to drive the path of food safety. it is time to realize that food safety cannot rely only on the production chain but potential risks to human health and the environment should be considered as well. the increasing advances in scientific and technological tools have now been adopted to assess such risks, thus opening a new era of "prediction" rather than "reaction" to reduce pathogen contamination and foodborne outbreaks ( ) . for example, the current trends in food safety research rely on the application of (i) genomic analyses for foodborne pathogen identification and traceability, (ii) geographic information systems (gis) to prevent and predict the spatial spread of pathogens outbreak, (iii) tools adapted from landscape ecology (species distribution and niche modeling) and social network analysis for predicting patterns of disease outbreaks, as well as guidance for interventions, and (iv) meta-analysis tools to confer an overall summary of available study findings, providing generalizable estimates and generating strategic highlights to be used by policymakers and decision makers ( ) . overall, risk prevention remains the key factor. the history of pandemics teaches us that almost all recent human pandemics and most of the emerging infectious diseases originated from animals (mainly in wildlife). it is known that species more resistant to human pressure are likely to become the new competent hosts of vector-borne diseases and then to become the most probable spillover agents toward human hosts ( , ) . furthermore, we must remember that biodiversity perturbation and its trivialization is the main trigger of virus spillover events ( ) , as probably happened for covid- (figure ) . given these assumptions, the international food policies concerning food safety should consider biodiversity and ecological interventions to prevent zoonotic spillover events. this would be especially urgent in rural areas, where farming and livestocking often overlap with wildlife species ranges and it has been documented that livestock species usually act as figure | list of the principal pandemic and emerging zoonotic viruses showing human-to-human transmission after the spillover is occurred. summarized host and spillover interface data are provided as in ( ) (mouse: directly from wildlife; swine: directly from domestic animals; mosquito: transmission by vector involving wildlife or domestic host respectively; u: unknown). detailed references for each listed virus are provided in ( ) . frontiers in nutrition | www.frontiersin.org intermediate hosts of spillover events (e.g., influenza a and sars coronavirus, figure ). for this reason, it is also time to rethink urban areas by projecting proximity buffer zones to prevent direct contact between agricultural/zootechnic activities and natural habitats. finally, the conservation of natural biodiversity and its related species interactions are essential conditions to reduce the risk of spillover events ( ) . on the whole, a cooperative work (rri-driven) involving human-health agencies, agricultural authorities, farmers, and natural resource managing institutions, could be essential to promote the global ecological management to avoid the spread of a new putative pandemic "covid- " or other risky vector-borne pathogens that may adversely affect human health, the environment and economy. our second consideration regards the fragility of citizens, especially the weakest ones such as the elderly, and their sensitivity to diseases. it is now clear that these social categories are the most susceptible to severe covid- outcomes, particularly if they already suffer from multiple pathologies. diabetes is the most common comorbidity observed in infected deceased patients in italy, after hypertension ( ) . furthermore, recent data showed a high prevalence of obesity ( %) and overweight ( %) in italian patients, median age years, from different italian icus, confirming evidence available so far in the literature supporting impaired immune response to viral infections ( ) . therefore, beyond the infectious capacity of this virus, it is important to focus on those elements of modern society which could increase citizens' vulnerability, including diet, lifestyle and environmental factors, strictly linked to morbidity and mortality for all non-communicable diseases (ncds) ( , ) . although this concept is well-established, today, the global average consumption of healthy foods is substantially lower than the reference dietary intake, whereas overconsumption of highly processed, energy dense, and nutrient-poor foods is increasing ( ) . the mediterranean diet is considered by unesco as one of the "intangible cultural heritage of humanity" with multiple health benefits, including fortification of immune defenses. however, epidemiological data on covid- would seem to contradict this belief since mediterranean countries (e.g., italy and spain) have the highest number of confirmed covid- cases in the world. five years after the expo , dedicated to the theme "feeding the planet, energy for life, " the city of milan, which hosted the event, is under siege by covid- pandemic. recent dietary changes within the mediterranean basin, with a decreased consumption of plant foods, increased consumption of fast meals and junk food, and negative health consequences such as rise in obesity rates and in ncds incidence (e.g., diabetes, cardiovascular diseases, and cancer) are partially responsible of this burden ( ) . the modern-day change in food choices is the results of lifestyle standardization, enhanced technologies in food production and processing and limited time for culinary activities. this caused for example the progressive erosion of mediterranean food cultures ( , ) . moreover, environmental emergence, such as water scarcity in most mediterranean countries and land wasting also has deleterious consequences on mediterranean food production. global climate changes have also produced the failure of several crops, fisheries, and livestock productions, and the declining of mediterranean biodiversity and agrobiodiversity does not allow the selection of new varieties and resistant breeds. so, once again the erosion of the environment and biodiversity is closely connected to health risks ( ) . how to react to these social and environmental changes showing serious health consequences? the sustainability of the food supply chain is certainly essential ( ) . kinnunen et al. showed that less than one-third of the world's population can meet their food demand within a -km radius ( ) . we should also change our view of food and diet which should no longer, or rather not only, considered an energy source but a reservoir of bioactive molecules beneficial to human health. greater consumption of health-promoting foods and limited intake of unhealthier options are intrinsic to the eating habits of certain regional diets such as the mediterranean diet ( ) . healthy dietary patterns positively influence health and promotes the prevention of common non-communicable diseases (ncds), strengthening host community defenses ( , ) . this concept assumes a particular importance since the over years old citizens could be more at risk of being infected by covid- , not only for intrinsic conditions due to natural aging processes and comorbidities development, but also for inadequate nutritional status and related inadequate intake of macronutrients (e.g., proteins and healthy fatty acids, like omega- ), micronutrients (e.g., vitamins a, b , b , c, d, e, and folate), trace elements (e.g., zinc, iron, selenium, magnesium, and copper) and phytochemicals which are pillars in preventing many chronic degenerative diseases and supporting the immune system ( ) . this would seem to be true even for younger patients with metabolic and cardiovascular diseases, showing severe acute respiratory distress syndrome (ards) caused by covid- ( ) . these considerations are also well-known for past pandemics. a recent retrospective data analysis from the pandemic flu, showed that nutrition played a consistent role in the severity of the disease and was related to mortality also in younger age groups ( ) . more recently, chronic malnutrition has been correlated to high morbidity and mortality during the influenza pandemic ( ) . similarly, malnourished children appear to be at increased risk for viral pneumonia ( ) . in dietary recommendation, fat quality has to be addressed ( ) , since evidence shows the need to achieve a balance between dietary intake of omega- and omega- for optimal nutrition ( ) , especially in those subjects more vulnerable to malnutrition and "silent inflammation" which disposes to a greater propensity to viral infections ( , ) . certainly, the presence of an unbalance between pro-and anti-inflammatory lipid mediators has been reported in literature ( ) and it is important to remark that science has already given solutions ( ) which are not adopted in new diagnostic policies for primary and secondary prevention. moreover, food supplements such as vitamins c and d might also be considered to help both innate and adaptive immune cells ( ) ( ) ( ) ( ) . studies on human coronaviruses (hcovs), including severe acute respiratory syndrome coronavirus (sars-cov), have highlighted that secondary metabolites of some plant species seem to inhibit virus proteins, cellular infection, and intracellular replication ( ) . extracts of spontaneous plants such as root tubers from rheum officinale baill. (rhubarb), root tubers or vines from polygonum multiflorum thunb., (polygonaceae) showed an inhibitory activity against the interaction of sars-cov s protein with ace ( ). procyanidins and other secondary metabolites extracted from cinnamomi cortex (cinnamomum cassia j. presl) can reduce the virus infection by interfering with endocytosis ( ) . the extract of cimicifuga rhizoma, meliae cortex, coptidis rhizoma, phellodendron cortex, and sophora subprostrata radix showed an ability to inhibit of rna-dependent rna polymerase and/or proteases crucial for coronavirus rna replication ( ) . finally, the antiviral activity of licorice (glycyrrhiza glabra l.), containing glycyrrhizin, inhibits replication, absorption and penetration of the sars-cov acting on the early steps of the replicative cycle ( ) . in this field, traditional chinese medicine is working actively to identify dedicated compounds to specifically contrast covid- infection ( ) . this practice relying on biodiversity and known as "bioprospecting, " may be a good strategy to find compounds having a positive effect on human health as well as to find new raw materials to produce novel and fortified foods for modern citizens. recently, di marco et al. ( ) suggested that the risk of emerging infectious diseases (eids) is a key aspect for developing suitable policy strategies at the global scale. within this framework, the conservation of biodiversity and food production are two additional pillars that should be considered to prevent drastic environmental changes and the risks of zoonoses, and virus spread. in figure we aimed at further remarking this concept including additional factors strictly related to covid- pandemic. from a nutritional point of view, addressing subclinical micronutrient deficiencies is one of the first steps that must be considered to improve resistance to infectious diseases like covid- (and other pathogens) ( ) . it is therefore recommended that micronutrient testing, such as vitamin d measurement, should be applied in the annual check up of selected individuals at high risk of deficiency ( ) . a nutritional approach, ensuring a long-term sustainability, is essential to improve micronutrient status by increasing the availability and consumption of micronutrient-rich foods ( ) . besides lifestyle changes, including diet has been shown to positively affect metabolic and cardiovascular diseases, which are the most frequent comorbidities associated to severe covid- disease. the spread of inappropriate eating habits and inactivity in western societies, particularly among the younger, "comfortably off " generations, has led to the development of chronic degenerative diseases defined as "comfort" diseases ( ) early in life, leading to an increase in premature deaths for ncds. food is readily available in developed countries but there is an evident split-up between scientific evidence, food choices, and dietary patterns of consumers. this, over time has favored the spread of the obesity epidemic and other diet-related diseases. it is time to acknowledge that environmental factors exert a major influence on dietary behavior, primarily by facilitating meals consumption away from home and by minimizing time dedicated to meal preparation and consumption and secondly, making food of poor nutritional quality available on the market and appealing for appearance, taste and price. this burden is exerted by market rules that affect behavior and food choices with scarce public awareness of the potential negative impact on health. it is necessary that science, technology, education, legislation, and community policies combine to create the urban structures and environment required to encourage healthy lifestyle including dietary choices, not just for few, but for everyone ( ) . more efforts must be addressed to reduce exposure to ambient air pollution, strongly associated with population density ( ), promoting chronic inflammatory state and affecting resilience to infectious diseases not last covid- ( ) . finally, western medicine generally tends to identify pharmacological molecules that act on specific disease mechanisms; however, human body complexity and individual answers are sometimes underestimated. thus, it could happen that infected patients die more due to comorbidities associated to infection with covid- than for covid- per se. the time has come to apply a systems biology approach where drugs, foods and lifestyle work in synergy to promote patient healing and prevent further infections, gaining a holistic approach to community health ( ) to support the further personalization of health and social care ( ) . for these reasons, in our scheme, we stressed the impact of environment and food system of therapeutic approaches. this integrative framework demands both an increased attitude of sharing by the scientific and technical community as well as a social participation since we believe that, as previously anticipated, food safety and human health should be regarded more as a social issue. our final suggestion is to start a frank and open scientific discussion on covid- issues and future risks for new pandemic outbreaks, continuing the legacy of expo , declared in the milan urban food policy pact, signed by more than cities in the world ( ) . in this document, the strategic role of the cities in developing sustainable food systems and promoting healthy diets is stated, yet acknowledging all the differences in their natural and policy endowments, including economic background and cultural innovation, managing vast public resources, infrastructure, investments, and expertise. these issues will be fundamental especially for those countries that are coming out of covid- lockdown restrictions and where it is more expected that political and social contrast will emerge if different stakeholders needs and opinions will not be analyzed and considered for planning the recovery after the pandemic event. we would like to undermine and integrate this overview with few take-home messages that arise from the teachings of this dramatic situation we are experiencing firsthand: (i) food safety is a global issue. the unsafety of local food markets, like the wuhan's one, can exert severe and global impact. (ii) smallholder food producers play a key role in feeding cities, by helping to maintain resilient, equitable, culturally appropriate food systems, and promote sustainable diets. in cities with a high percentage of elderly, local food production should be tailored for specific targets to maintain adequate nutritional status, including fortification of immune system. similarly, in developing countries, smallholder farms should improve the production of local crops rich in macro and micronutrients to improve food security and health of local populations ( ) . (iii) acknowledgment that urban and peri-urban agriculture may offer opportunities to protect and integrate biodiversity into urban landscapes and food systems, thereby contributing to synergies across food security, ecosystem services, and human wellbeing. this is very important to prevent the spillover of viruses but also to offer better efficacy of new drugs synthesized to fight future diseases. a unified approach to nutritional screening and assessment is recommended guiding toward integrated panels of biomarkers to investigate the nutritional status and predict future health outcomes of the individual and moving from stratified to personalized to precision nutrition ( ) . the whole scientific community should start sharing directions, social actions and policy advocacy recognizing that the health of people is closely connected to the health of biodiversity and ecosystems where they live. in this context, the "one health" approach (https://www. cdc.gov/onehealth/basics/index.html) represent a good starting point for successful public health interventions by fostering collaboration across all sectors, taking the right steps to promote health not for the few but for the whole planet. the original contributions presented in the study are included in the article/supplementary materials, further inquiries can be directed to the corresponding author/s. this opinion paper was conceived by ml, ag, and hc. all authors contributed to its execution and write up with ml leading on the manuscript structure, biodiversity-related aspects were contributed ag and mc, nutrition aspects by hc, botanic and phytochemistry aspects by md, es, ef, and lc, and medical aspects by mr and mb. covid- : what is next for public health? the epidemiology and pathogenesis of coronavirus disease (covid- ) outbreak the junction of health, environment and the bioeconomy: foresight and implications for european research and innovation policies the early landscape of coronavirus disease vaccine 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patients with covid- disease vitamin d testing and treatment: a narrative review of current evidence improving diets and nutrition: food-based approaches. rome: cabi dietary attitudes and diseases of comfort available online at air pollution and population health: a global challenge is there an association between exposure to air pollution and severity of covid- infection? oxford covid- evidence service team centre for evidence-based medicine ( ) putting the patient back together-social medicine, network medicine, and the limits of reductionism developing the power of strong, inclusive communities. a framework for health and wellbeing boards office for public management potential role of neglected and underutilized plant species in improving women's empowerment and nutrition in areas of sub-saharan africa the authors are grateful to davide magnani for artworks support. the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.the reviewer ml declared a past co-authorship with one of the author mr to the handling editor.copyright © galimberti, cena, campone, ferri, dell'agli, sangiovanni, belingheri, riva, casiraghi and labra. this is an open-access article distributed under the terms of the creative commons attribution license (cc by). the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. key: cord- -rtm dn authors: o’connor, karen; wrigley, margo; jennings, rhona; hill, michele; niazi, amir title: mental health impacts of covid- in ireland and the need for a secondary care mental health service response date: - - journal: irish journal of psychological medicine doi: . /ipm. . sha: doc_id: cord_uid: rtm dn the covid- pandemic is a global health emergency, the scale, speed and nature of which is beyond anything most of us have experienced in our lifetimes. the mental health burden associated with this pandemic is also likely to surpass anything we have previously experienced. in this editorial, we seek to anticipate the nature of this additional mental health burden and make recommendations on how to mitigate against and prepare for this significant increase in mental health service demand. the psychosocial footprint associated with a major emergency is typically larger than the medical footprint. this is because the psychosocial impact extends beyond those who suffer direct medical injury to first responders, healthcare professionals delivering care to the ill, family, friends and the wider community (nato joint medical committee, ; shultz et al. ; health service executive, ) . the covid- pandemic is a global health emergency, the scale, speed and nature of which is beyond anything most of us, service users, healthcare staff or the general public have experienced in our lifetimes. the mental health burden associated with this pandemic is also likely to surpass anything we have previously experienced. therefore, it is essential for mental health services in ireland to anticipate the nature of this need and plan a coordinated response to address it (see fig. ). to better define and plan for the mental health impact of this pandemic, an expert working group was formed in the office of the national clinical advisor and group lead for mental health in the health service executive in ireland. this expert working group was made of up of the authors and involved additional consultation with mental health experts from across the mental health specialties including general adult, child and adolescent, intellectual disabilities and psychiatry of later life. the likely timeline and nature of the various waves of health needs that will arise because of the covid- pandemic are illustrated in fig. . while the irish health service must prepare in the first instance for the first pandemic wave, we also need to plan and mitigate against the impact of the subsequent three waves of healthcare need (see fig. ). the second wave will arise because people who are in acute need of health care, for example, myocardial infarction or first-episode psychosis forestall accessing care because of fears of covid- infection or because in isolation their symptoms are not recognised. this could result in a significant increase in acute non-covid morbidity and mortality. the third wave will arise from the longer-term impact on people with established health problems, for example, diabetes, eating disorder or schizophrenia not accessing routine care due to health service reconfiguration, service reduction or fears of infection. this will result in people who were stable, deteriorating over time. for example, an individual is unable to attend the diabetic clinic because it is cancelled or delayed, resulting in poorer glycaemic control. a mental health example might be where an individual with an established psychotic illness is unable to attend their weekly therapeutic group, loses their job, has their routine outpatient review rescheduled and experiences increased loneliness, isolation and a relapse of psychotic symptoms. the largest and longest fourth wave of healthcare need will encompass the psychosocial and mental health burden associated with this pandemic. this final tsunami will not peak until sometime afterwards (months) and will sustain for months to years after the covid- pandemic itself. a proportion of this psychosocial and mental health need can be met at a community and primary care level in the first instance. however, a significant proportion will require specialist intervention from secondary care mental health services. in this editorial, we seek to describe and make recommendations on how to mitigate against and prepare for this increase in mental health service demand. however, it is important to note that any plan developed in the context of this pandemic will require review and revision as further evidence becomes available. features particular to this pandemic that will result in an increased mental health burden in the medium to longer term there are several features particular to the covid- emergency that are likely to amplify and prolong both the psychosocial and the mental health burden associated with this pandemic. these features include the morbidity and mortality associated with covid- , the relentless media coverage, the social distancing measures, the altered pathways to access care, the changes to the care that is available, the suspension of development plans in mental health services and the economic impact on all populations in society. table describes these features in more detail. the social distancing measures do not impact on all equally. those with the fewest social and economic resources to alleviate the effects of social restrictions will be impacted the most (morgan & rose, ) . this includes those living in deprived areas, with insecure and or low-income jobs, insecure housing, singleparent households or abusive relationships. it also acutely affects those with existing mental health problems, whose symptoms may worsen when access to social connections and healthcare support is restricted. the economic impact of the pandemic will further exacerbate and prolong this. the national clinical programmes (ncps) in mental health were developed in conjunction with the college of psychiatrists of ireland and are nationally led programmes seeking to improve access, quality and cost of mental health care. there are also two nationally led initiatives to support the development of perinatal mental health services and mental health services for people with an intellectual disability. these programmes were developed to address areas of known service deficit, or indeed where there was an absence of service. the continued implementation and investment in these ncps need to be enhanced during covid- . groups who will be particularly vulnerable to the emergence of new mental health difficulties requiring secondary care interventions this pandemic will be associated with an increase in people presenting for the very first time with significant mental health difficulties. several groups are likely to be particularly vulnerable. some people who have had a severe episode of covid- illness may experience high levels of psychiatric family members who have lost a loved one, who were separated from loved ones who were very ill and or died may be vulnerable to developing psychiatric relentless media coverage difficult to cope with anxiety, fear and anticipation of the pandemic. difficulty sleeping, eating, taking a break from coverage and impact. social distancing measures greater impact on vulnerable groups, for example, those in poverty, insecure housing/work, single-parent families, abusive relationships, direct provision and people with mental illness who will have less social and professional support. secondary economic crisis well-established association with higher rates of mental illness, suicide and substance use disorders reduced non-covid- health service utilization reluctance to attend for acute care due to fears of covid- infection resulting in delays in effective treatment and increase in crisis presentations reduced availability/altered access to mental health services reconfiguration of services and redeployment of staff results in reduced access to care retraction of the national clinical programmes • self-harm • inability to meet the anticipated increase in self-harm presentations • associated with increased morbidity, mortality and increased burden on community mental health teams • early intervention for psychosis failure to implement national roll out in line with model of care resulting in: • increase in duration of untreated psychosis and an associated worsening of prognosis. • failure to deliver evidence-based interventions resulting in increased relapse, increased crisis presentations, increased hospital admissions, worse health outcomes. • eating disorders failure to implement national roll out in line with model of care resulting in: • delays in accessing service • increased reliance on costly hospital admissions and expensive out of country placements. • failure to deliver evidence-based interventions resulting in poorer prognosis, increased crisis care and increased reliance on hospital admissions • attention deficit hyperactivity disorder in adults failure to implement national roll out in line with model of care resulting in: • little to no access to assessment and treatment in adults mental health impacts of covid- in ireland illness. it was estimated that % of family members of sars patients experienced psychological problems (mainly depressive symptoms) and stigmatisation (tsang et al. ) . in the sars research, healthcare professionals were found to be particularly vulnerable to psychiatric morbidity during and after the acute pandemic wave (wu et al. ). a study of healthcare workers in beijing, china, years after the sars epidemic found that % continued to experience high levels of posttraumatic stress (wu et al. ). those with fewer social and economic resources as described previously, those living in difficult or unstable personal/housing/employment circumstances will likely experience greater mental health impact and burden. leading theories of suicide emphasise the critical role that social connections play in suicide prevention (reger et al. ) . individuals experiencing suicidal ideation may lack connections to other people and often disconnect from others as suicide risk rises. social distancing itself may be a significant risk factor for an increase in self-harm and suicide for some people. the economic impact of the pandemic is becoming increasingly apparent, with unemployment rates rising dramatically, which is an established risk factor for mental ill health across the lifespan. this is likely to further compound this vulnerability and increase these risks (corcoran et al. ) . while these issues effect all age groups, there are subgroups that are likely to be more vulnerable. older people who are at higher risk of developing a severe form of covid- , particularly those who have been asked to cocoon, may be experiencing more anxiety and more isolation. disrupted routines and reduced activity levels may undermine independence, exacerbate frailty and poor health outcomes in this population. for those with dementia living at home, an incomprehensible disruption to the person's usual routine can lead to anxiety, agitation and sleep disturbance. not being able to leave the house may cause an extreme reaction towards well-meaning family carers causing distress to all. in nursing homes, family and friends no longer being able to visit will distress residents. this is particularly true of those who are cognitively intact who may be equally worried about their families catching covid- . this is especially the case if they are aware of the deaths of fellow residents from covid- . young people (aged - ) are already the highest risk age for developing a mental disorder, and third-level students report even higher levels of distress than their age-matched peers (karwig et al. ; union of students of ireland, ). a combination of accelerated brain development and the developmental task of transition to adult life and learning are some of the explanatory factors (duffy et al. ) . these preexisting vulnerabilities are not removed by the pandemic, and fears and uncertainty about future employment and economic stability are likely to be exacerbated by the financial impact on all of society. prior to covid, the my world survey in , a self-report survey, showed that the already high rates of depression, anxiety and self-harm in young people reported in my world survey ( ) had risen even further (dooley, ) . irish youths have the fourth highest suicide rate in europe (unicef, ). covid is likely to impact more on the mental rather than the physical health of this group. with austerity measures, separation from peers and forced quarantine with family (who in some cases may not be a safe space) are being challenges for young people. many have had their school and college lives disrupted, their state or college exams altered or brought forward. their already uncertain futures looking even less clear. there are of course exceptions, for example, those with social anxiety or who were experiencing bullying. however, those subgroups will likely need even further support to re-engage with society after social restrictions are lifted. individuals with intellectual disability may struggle to understand the requirements of social restrictions and may find the disruption to their routines and reduced access to usual social supports, for example, work, and day programmes as very distressing. people with autism, within the learning disability population, may be particularly impacted, as changes in routine can be incredibly challenging for them. rates of mental ill health within the learning disability population already exceed those in the general population and the pandemic may exacerbate this further (hughes-mccormack et al. ). some individuals with intellectual disability live in congregated settings. such settings may be more vulnerable to covid- infection outbreak, and this may result in increased exposure to the morbidity and mortality and, therefore, opportunity to witness the impact on others of this pandemic. the covid- pandemic is associated with a combination of factors such as worry about infection, direct effects of the virus on the foetus or on an infant, visitor restrictions, social isolation, financial strain, domestic violence and grief due to loss of family members that are likely to increase the prevalence of mental health difficulties in women during the perinatal period. the impact of no visitors in the post-partum period, or of no partner being permitted during caesarean sections during covid- , may be very anxiety provoking for some. reduced social support in the post-partum period, increased economic pressure and increased risk of domestic violence are additional potential stressors in this population. as mentioned previously, there are two nationally led clinical programmes in place to support the development of mental health services for people with an intellectual disability and the perinatal mental health services. it is critical that in the context of covid- , the development of these services is fast-tracked. people with established mental illness are likely to be particularly vulnerable to relapse, exacerbation of symptoms and impaired functioning in the context of the covid- pandemic (see table ). furthermore, people with established mental illness also have a lower life expectancy and poorer physical health outcomes compared to people in the general population (rodgers et al. ) . risk factors associated with poorer outcomes in covid- infection include smoking, diabetes, cardiovascular disease and obesity. these risk factors are all more prevalent in people with established mental illness. as such, people with established mental illness may be at risk of poorer mental health and physical outcomes in this pandemic (cullen et al. ) . funding of mental health services in ireland has remained consistently low,~ % of the overall health budget (compared to % in new zealand and united kingdom) (college of psychiatrists of ireland, ). ireland has the third lowest number of psychiatric beds in europe (eurostat, ). the staffing recommendations for mental health teams set out in a vision for change have never been achieved. the latest data from the health service executive in december put the staffing levels of child and adolescent mental health teams, psychiatry for older persons teams and psychiatry for people with an intellectual disability, as a percentage of avfc recommendations at %, % and %, respectively. mental health services are underfunded across the board; however, there is a societal recognition of the mental health needs of young people, and yet they struggle the most to access secondary care. this is perhaps a result of the traditional adult-paediatric split, which does not match the epidemiology. it may also be a consequence of underfunded services being unable to respond to young people until conditions are much more entrenched or repeated crises have occurred. like the scenario faced by intensive care units at the start of this covid pandemic, in mental health, we are starting at a low base and facing into a tsunami of mental health need. similar to the approach taken in the acute hospitals, we need urgent investment, building of capacity and innovation to ensure that mental health services are not overwhelmed and are able to respond to service users in a timely manner. ring fence a specific budget to allow mental health services to build capacity, adapt and innovate. in line with slaintecare, we need to have the right care, available at the right time, in the right place (houses of the oireachtas committee on the future of healthcare, ). redeployment of mental health staff during the acute pandemic should be minimised and only occur in very extreme and time-limited circumstances. a ring-fenced covid- research budget, within a collaborative interagency framework, should also be introduced. services will need to adapt and transform. however, it is critical that evolving approaches are evaluated to ensure feasibility/ acceptability and that they are associated with good health outcomes for service users and their families. youth mental health services rest in the domain of primary care counselling services in ireland, with no representation from psychiatry, perhaps reflecting a misguided belief in the general population, and at government level, that mental illness can always be prevented. these services are ill equipped to manage the full range of presentations that seek help. without funded vertical integration pathways and ring-fenced funding to secondary care, there is a risk that already limited funding in amhs and camhs will be channelled away from where it is most needed. even in countries with significantly more enhanced primary care youth mental health services, there is a recognition that % of young people who present (headspace australia) have needs that are in excess of what can be managed there (rickwood et al. ) . the youth mental health taskforce recommended appointment of national and local ymh leads, a focus on improving mental health services in third-level institutions, and upscaling of digital interventions all of which now need to be implemented (national youth mental health taskforce, ) . mental health impacts of covid- in ireland increased risk of relapse of anxiety disorder symptoms including panic attacks, agoraphobia, health-related anxiety symptoms obsessive-compulsive disorderfear of contamination and increased compulsive behaviours, for example, handwashing, checking, routines. increased risk of trauma relating to the experience of covid- illness or witnessing impact of illness on service user, friend and family. increased social isolation and loneliness insomnia, altered appetite, reduced exercise, disrupted routine. personal experience of covid- in self/family or friends. rates of isolation and loneliness are higher in this population at baseline. increased difficulty accessing care due to altered pathways and increased isolation from family/friends. those with negative symptoms will be particularly affected by the change in routines, reduced interaction and social distancing measures. viral infection appears to be a general risk factor for psychotic disorders, and coronavirus infection may also be a specific risk factor, conferring acute and long-term risk for psychosis (cowan, ) . trauma and social marginalisation are risk factors associated with longer term increased risk of psychosis (radua et al. ) . relapse of psychotic symptoms, for example, hallucinations, delusions. increased duration of untreated psychosis resulting in poorer prognosis. further impairment of social and occupational functioning, which will be difficult to re-establish after covid- . difficulty/fear of accessing evidence-based interventions, for example, psychological interventions, family interventions, individual placement support, physical health interventions. impact of telephone versus face-to-face assessments, therapeutic interventions. potentially increased longer-term risk of psychosis in the population. the rapid upscaling of the information technology infrastructure has been a very positive consequence of covid- . however, access to smart phones, laptops and high-quality broadband is an issue in many areas. this needs to be addressed as a priority. we also need to adapt and develop digital health interventions, for example, psychological interventions, family interventions, peer to peer supports, physical health interventions to augment services capacity to deliver evidence based care in the context of covid- (alvarez-jimenez et al. ) . the need for electronic records and data collection systems that monitor patient outcomes should also be developed in tandem with telemedicine. a specific budget to support and protect the implementation of the ncps during covid- should be identified. adequate resourcing of these programmes will ensure that areas of the mental health service that have already been identified as severely lacking will be able to meet demand. now is not the time to fall backwards in the delivery of high quality, accessible care. rather we need to accelerate service transformation and to build and strengthen capacity in our mental health services. because of covid- , secondary care mental health services are facing a huge escalation of mental health need. it is emerging now, will peak in a few months' time and will last for many months to years. now is the time to flatten this curve. unless we anticipate, plan and invest in all our secondary care mental health services as a priority, they will be overwhelmed with terrible consequences for the mental health and economic recovery of our country. the authors have no conflict of interest to disclose. the author asserts that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committee on human experimentation with the helsinki declaration of , as revised in . the authors assert that ethical approval was not required for publication of this manuscript. this article received no specific grant from any funding agency, commercial or not for profit sector. online social media: new data, new horizons in psychosis treatment mental health in 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cord_uid: qgny f y in kenya, millions of children have limited access to nurturing care. with the coronavirus disease (covid- ) pandemic, it is anticipated that vulnerable children will bear the biggest brunt of the direct and indirect impacts of the pandemic. this review aimed to deepen understanding of the effects of covid- on nurturing care from conception to four years of age, a period where the care of children is often delivered through caregivers or other informal platforms. the review has drawn upon the empirical evidence from previous pandemics and epidemics, and anecdotal and emerging evidence from the ongoing covid- crisis. multifactorial impacts fall into five key domains: direct health; health and nutrition systems; economic protection; social and child protection; and child development and early learning. the review proposes program and policy strategies to guide the reorientation of nurturing care, prevent the detrimental effects associated with deteriorating nurturing care environments, and support the optimal development of the youngest and most vulnerable children. these include the provision of cash transfers and essential supplies for vulnerable households and strengthening of community-based platforms for nurturing care. further research on covid- and the ability of children’s ecology to provide nurturing care is needed, as is further testing of new ideas. the coronavirus disease (covid- ) pandemic is spreading in unprecedented ways and has a significant impact on nurturing care and early childhood development outcomes. currently, there are over eighteen million covid- confirmed cases globally, kenya recording over , cases as of of therefore, there is a need to mitigate the impact of covid- by prioritizing programs and policies that support the continuum of ecd [ ] . anecdotal evidence in kenya shows that the covid- pandemic is contributing to deteriorating optimal environments that threaten children's early development and has direct health impacts on caregivers and children [ ] [ ] [ ] . strategies are required to prioritize a range of ecd interventions during the covid- pandemic to support caregivers so that they can meet the needs of their young children. ecd goes beyond improving child survival to enabling children to reach their full potential through cognitive, socio-emotional and physical development. failure to prioritize ncfecd will lead to a future pandemic where children who are presently most vulnerable, will have significant deficits on their health, wellbeing and productivity. previous pandemics have had long-term negative impacts over multiple generations. the development of children who were exposed to the asian influenza pandemic in , while in utero, was hampered with evidence of poor cognitive development [ ] . the spanish flu was reported to lower educational attainment for those individuals whose mothers had potential in utero exposure [ ] . in japan, primary school children born between to were shorter than those in surrounding cohorts [ ] . the timing of the prenatal exposure to influenza was also reported to have had worse consequences in those who were exposed in early gestational to weeks, as it was associated with delayed psychomotor development at months of age [ ] . in fact, it has been established that the spanish flu had negative outcomes in later life for those who were exposed in utero in several countries such as the usa [ ] , brazil [ ] , switzerland [ ] , and taiwan [ ] . in a narrative review of infants and children with congenital zika virus, epilepsy and motor abnormalities were noted [ ] . wearing masks to prevent the transmission of sars also negatively impacted communication between children and adults, and was also threatening to children who had been sexually abused [ ] . the hiv pandemic had a negative impact on child growth and development. globally and in sub-saharan africa including in kenya, young children affected by hiv particularly those who are hiv-infected, have a high risk of mental health problems, neurocognitive deficiencies, developmental delay, and poor nutrition outcomes [ ] [ ] [ ] [ ] [ ] . the hiv pandemic generated a lot of lessons related to ecd. however, for a very long time, ecd was associated with child survival only, without a strong focus on promoting thriving and transforming [ ] . ecd-related outcomes such as cognitive impairment and developmental delays as well as long-term impacts across the life course have not been tracked widely. even where there are attempts to focus on thriving and transforming, during epidemics and pandemics, the focus reverts to child survival. despite the frequency of epidemics, there is a scarcity of research on holistic ecd outcomes in the sub-saharan africa context. where research in sub-saharan africa exists, it has focused on other types of emergencies such as conflict and refugee crises [ ] . there are several far-reaching, interlinked direct and indirect impacts of the covid- pandemic and associated control measures on nurturing care and related ecd outcomes including children's cognitive, physical, language, motor, and social and emotional development (figure ). these include direct physical and mental health impacts resulting in illness and/or death from covid- infection, and severe stress leading to deterioration of mental health and well-being. with deaths increasing, many children are becoming orphaned or experiencing greater adversity. covid- has also affected access to health and nutrition systems including routine immunizations. social impacts include increased teenage pregnancies and a rise in gender based violence, all with a bearing on ecd outcomes. they also include lack of social and child protection services to support parents and primary caregivers. furthermore, child development and learning impacts including lack of access to institutional-based childcare services and critical nurturing environments have become more severe during this period, affecting the learning that children need during the most critical period of brain development. finally, the economic impacts have a direct interplay with all other impacts, and have contributed to increased stress among caregivers and children. in some places, it has resulted in food insecurity, thereby also influencing children's physical health. all these impacts have short-term consequences that will translate into long-term changes in children's life trajectories. deaths increasing, many children are becoming orphaned or experiencing greater adversity. covid- has also affected access to health and nutrition systems including routine immunizations. social impacts include increased teenage pregnancies and a rise in gender based violence, all with a bearing on ecd outcomes. they also include lack of social and child protection services to support parents and primary caregivers. furthermore, child development and learning impacts including lack of access to institutional-based childcare services and critical nurturing environments have become more severe during this period, affecting the learning that children need during the most critical period of brain development. finally, the economic impacts have a direct interplay with all other impacts, and have contributed to increased stress among caregivers and children. in some places, it has resulted in food insecurity, thereby also influencing children's physical health. all these impacts have short-term consequences that will translate into long-term changes in children's life trajectories. . . . impacts on children's health covid- is an evolving pandemic, and despite the worldwide spread, the effects of covid- on pregnancy, childbirth in addition to newborns and toddlers are not well-established, and the evidence is mixed. recent experience suggests there is a low risk of intrauterine infection by vertical transmission in women with covid- disease [ ] [ ] [ ] , although the first case of vertical transmission was recorded in july in india [ ] . a systematic review by zimmermann and curtis ( ) [ ] on covid- in children, pregnancy and neonates reported fetal distress in % of pregnancies, with % of women having preterm deliveries. neonatal complications including respiratory distress or pneumonia ( %), disseminated intravascular coagulation ( %), asphyxia ( %) and two perinatal deaths were also reported. . . . impacts on children's health covid- is an evolving pandemic, and despite the worldwide spread, the effects of covid- on pregnancy, childbirth in addition to newborns and toddlers are not well-established, and the evidence is mixed. recent experience suggests there is a low risk of intrauterine infection by vertical transmission in women with covid- disease [ ] [ ] [ ] , although the first case of vertical transmission was recorded in july in india [ ] . a systematic review by zimmermann and curtis ( ) [ ] on covid- in children, pregnancy and neonates reported fetal distress in % of pregnancies, with % of women having preterm deliveries. neonatal complications including respiratory distress or pneumonia ( %), disseminated intravascular coagulation ( %), asphyxia ( %) and two perinatal deaths were also reported. the epidemiological and pathophysiology of covid- in children remains unclear. evidence from china [ ] , italy [ ] , netherlands and the uk [ ] indicate that children represent less than % of diagnosed covid- cases. however, children under one year and those with comorbidities such as asthma are more likely to be hospitalized [ ] . although covid- in children seems to have mild symptoms, there is a high prevalence of pneumonia associated with covid- in children at % [ ] . the majority of children have less severe symptoms, and thus are less likely to be tested, leading to an underestimate of child infections. indeed, studies confirm that severe illness and mortality from covid- is rare in children [ ] . however, there are emerging concerns of a novel severe kawasaki-like disease in children related to covid- that may represent a post-covid infectious syndrome [ ] . in a systematic review, children were found less likely to be the main drivers of the pandemic compared to adults who get severe disease [ ] . in kenya, the reported cases of young children testing positive for covid- are low; % of reported cases as of th july were children aged - years with a % case fatality rate [ ] . although children do not account for the majority of cases, they are likely to face the most substantial impact of the covid- pandemic [ ] . consequently, a focus on children, and especially the youngest, is vital not only due to the impact that they may face during the current crisis, but also because the negative impact has the potential of persisting across their lives in many years to come. there is also heightened stress and psychosocial difficulties among parents and caregivers that threaten the provision of optimal nurturing care environments which children need to achieve their potential [ ] . worry, stress, and being anxious have been reported among % of kenyans due to covid- [ ] . school and daycare closure, job losses, economic uncertainty, inability to afford food and lack of access to essential services have resulted in increased stress and anxiety among caregivers. some level of stress is normal and can even be beneficial when it is positive, but when it is elevated, constant and adds to existing adverse conditions, it can become toxic [ ] . toxic stress can have long-term impacts on a person's hormones, thereby affecting a child's brain architecture, physiological and chemical makeup, and overall development over a lifetime that may never be fully reversed [ ] . the ministry of health in kenya developed a comprehensive guide for health workers on mental health and psychosocial support during the covid- pandemic to cover the needs of the population and people on treatment for covid- [ ] . however, it is not clear if this has been widely disseminated, and the extent to which various population segments are benefitting from the guidance is also unclear. access to material and psychosocial support, caregivers' and families' ability to cope with the pandemic and its consequences may be limited, and they may not be able to provide effective nurturing care [ , ] . when children experience trauma, experience adversity and lose secure attachment and bonding due to deficiencies in responsive caregiving, they experience stress, which has negative impacts on their health, wellbeing and lifelong learning, including a higher risk for developing a variety of cognitive, behavioral and emotional difficulties later in life [ ] . aside from the direct health impacts on the physical and mental health and wellbeing of children, caregivers and families, covid- has also affected health systems and disrupted access to routine nurturing care services. covid- has placed a strain on the overstretched healthcare systems, a key entry point for nurturing care, and disrupted the delivery of vaccination of children under five years due to supply chain and human resource constraints [ ] . the weak health systems in lmics such as kenya are vulnerable to the spread and impact of covid- , having witnessed service disruptions and lack of preparedness in the face of the crisis. the basic tenets of the right to health are being tested. public health expenditure as a percentage to gdp is deficient in the region, and kenya stands at . %, far below the recommended % per the abuja declaration [ ] . the country already had a shortage and maldistribution of health workers, but with covid- , the disparities in access to healthcare between the rich and the poor in urban areas, as well as between the rural and urban divide, are widening. though most nurturing care interventions in kenya begin at birth, maternal preconception health and wellbeing influences child development. intrauterine growth restriction has been linked to adverse outcomes including prematurity, low birth weight, stunting, anemia, neurodevelopmental conditions, stillbirths and child mortality [ , ] . evidence from lmics shows that reproductive, maternal, newborn and child health interventions including iodine, iron and folate supplementation during preconception have had a significant impact on children's cognitive, physical and socio-emotional wellbeing [ ] . the uptake of preconception care in kenya is very low since over % of the pregnancies in the country are unintended [ ] . notably, the majority of the unintended pregnancies occur in young girls who take time to acknowledge their pregnancies. this leads to delay of the first antenatal visit and, in some instances, non-uptake of antenatal services throughout the pregnancy [ ] . in a context where covid- has led to an increase in the number of teenage pregnancies as well as a disruption in routine care, the net effect will be delays and low uptake of antenatal services. consequently, there may be an increased risk of infant and maternal morbidity and mortality. the covid- pandemic has disrupted maternal and child health and nutrition, including antenatal, skilled delivery and postnatal services, as well as immunizations, health education and promotion, all resulting in a reversal of the previous gains made in reducing maternal and neonatal mortality [ ] . the reduced accessibility of essential maternal and child health and nutrition services is worsening ecd outcomes and further exacerbating disparities among vulnerable households such as those living in informal urban settlements. the pandemic threatens the continuity of critical and essential services for expectant women, newborns, and children under five years including those with disabilities and developmental delays. the reluctance of parents to visit clinics due to fear of infection with covid- may also interrupt immunization and other child health programs [ ] . the social distancing, lockdown and curfew measures have led to decreased utilization of maternal health services. pregnant women experience challenges in accessing health and nutrition services, which has been worsened by the covid- crisis. for example, lack of transport during lockdown and curfews, and fear of visiting health facilities due to concerns regarding covid- infection have been observed [ ] . maternal and child malnutrition, including micronutrient deficiencies and child stunting are expected to increase [ ] . mothers and children need access to key essential nutrition actions and services so that they are well-nourished pre-conceptually, intrapartum and during lactation. furthermore, they also need services to diagnose and address micronutrient deficiencies through iron and folic acid (ifa) supplementation to prevent neuro-developmental disabilities in children [ ] . however, anecdotal reports confirm reduced utilization of maternal and child health services in kenya, worsened by infection of some health workers leading to the suspension of maternal services [ ] . likewise, in sierra leone and liberia, the ebola crisis exacerbated the poor health outcomes within weak health systems [ , ] . liberia and guinea experienced a sharp decline of more than % in the monthly number of children vaccinated against measles in and due to the ebola outbreak as compared to the previous years [ ] . the indirect effects of ebola on maternal and child health were believed to be greater than the direct consequences [ ] . antenatal care, family planning, facility delivery and postnatal care were adversely affected, leading to an increase in maternal neonatal and stillbirth deaths in - [ ] . the economic well-being of a family affects a child's ecd outcomes because it affects the child's ability to be in a safe and protective home and access health services and programs and nutritious foods, all of which cost money. children growing up in vulnerable households face even greater challenges to thrive given the pandemic and existing adversities [ ] . the directives to reduce transmission through social distancing, hand-washing, self-isolation and self-quarantine for days for those exposed to the virus may be unattainable for informal settlement residents who have space limitations and limited access to water, sanitizers and masks. families who were already vulnerable prior to the pandemic have been pushed to dire circumstances with losses in income and are unable to afford basic necessities, while others juggle work and childcare among other responsibilities. stay at home orders and lockdowns are unlikely to be followed through as quest for food and basic commodities is necessary [ ] . the economic impacts of the pandemic are anticipated to have far-reaching consequences on long-term health and wellbeing of the population compared to the direct health impacts [ ] . there is a downward trend in the kenyan economy marked by job losses, inconsistent food supply and an increase in stress levels among adults and children [ ] . the pandemic has caused a severe unemployment crisis in kenya, with at least one million people having lost their jobs or been placed on indefinite unpaid as of june in both the formal and informal sectors [ ] . there was a marked decline in labor force participation from % in to % in april , and women are the most affected with a participation rate of % compared to men at . % [ ] . the government has introduced various fiscal policy and income support measures such as tax waivers, reduction in taxes for all micro, small and medium enterprises, as well as covid- emergency funds and earmarked funds for social protection in the form of cash transfers [ ] . however, the number of vulnerable families continues to increase as the pandemic persists. families living in informal settlements live in overcrowded areas and lack basic housing, water and sanitation, which make them vulnerable to disease outbreaks despite having the knowledge of covid- measures [ , ] . contact tracing has shown local transmission of covid- to rise as community transmission becomes a significant driver, especially with people living in a big families leading to an increase in deaths [ ] . this can be related to the respiratory viral transmission of covid- through direct contact in the households where space is inadequate and social distancing impossible. families also continue to experience other non-covid- -related health challenges coupled with movement restrictions, placing caregivers of children at greater risk of morbidity and mortality. as the situation continues to unfold and countries adopt this 'new normal', the potential negative impact of the prevailing situation on unborn and young children cannot be ignored [ ] . holistic child development requires a stimulating, safe environment, social interaction, education opportunities and adequate nutrition, all of which have been affected in one way or another [ ] . the resultant economic impacts of covid- have been felt at household level with a ripple of negative impacts on nurturing care. there has also been increased risk of abuse, neglect and violence against children of all ages [ ] and domestic violence in kenya [ , ] . children with developmental delays and disabilities are very vulnerable and are often subjected to stigma and various forms of neglect and abuse [ ] . stress and anxiety among children are also likely due to disrupted routines. routines are critical to enabling children to thrive in supportive environments in the home, childcare and early learning centers. all these circumstances mean that children in lmics such as kenya are at risk of faltering outcomes, as caregivers find it challenging to provide their children with the nurturing care they need during this pandemic. children need a safe, secure and loving environment, yet these stressful experiences in early life increase the risk of developmental delays and non-communicable disease in later life [ , ] . therefore, to promote safety and security, families and children need to live in safe environments, where children experience supportive discipline and do not experience neglect or violence. responsive caregiving ensures sensitivity to children's cues, thus promoting play and stimulation for early learning through day-to-day activities as well as caregiver-child interactions that are enjoyable [ , ] . it is plausible that with the lockdown and restrictions on movement, caregivers and families may have limited access to child protection services and programs. where the services are present, they may experience difficulties reaching and providing care to vulnerable children. the closure of "babycares" may have implications for child protection, as the children are not being looked after by caregivers who offer an environment with some level of safety and security. due to the ongoing crisis, children may also be locked up and restricted from exploring their environments or playing with other children due to fear of infection. without access to social protection, caregivers facing heightened vulnerability due to loss of income may lack the safety nets to provide for and protect children. in cases where caregivers succumb to direct covid- infection or due to the indirect health impacts of covid- , children are orphaned. this affects children's access to basic needs and nurturing care [ ] . the experience of bereavement itself is a form of adversity, and could lead to emotional and psychological trauma, and induce fear and a sense of helplessness in children without positive coping mechanisms [ ] . orphaned and vulnerable children have an increased risk of being neglected, harmed, exploited, and they may experience gender-based violence, including early marriage. they also miss out on opportunities for play, a crucial aspect of child development and early learning. in kenya, there is weak oversight of services to support orphaned and vulnerable children. traditionally children would live with other relatives, and, in general, family-based care is preferred to institutional care where there are reports of abuse, neglect and exploitation [ ] . however, with covid- putting increasing food insecurity and economic hardships of families, orphaned and vulnerable children may not be supported in these families without the provision of safety nets. high teenage pregnancy is not new in kenya. data from the demographic and health surveys show that almost out of girls between the ages of and are reported to be pregnant or already had a child [ , ] . this trend has been fairly consistent for more than two decades with little change in prevalence between and . nevertheless, in light of the covid- pandemic, the trend of teenage pregnancy is already showing signs of being more severe as a result of prolonged school closure, sexual violence and the declining economic situation in kenya [ ] . this trend is dire, as girls from poor families across the country are engaging in transactional sex to acquire money to buy sanitary pads and food [ , ] . globally, it is predicted that due to the harsh economic times, the number of girls involved in survival sex will increase [ ] . previously, girls were able to access free sanitary towels through their schools; however, this is no longer the case since schools were closed following the covid- crisis [ ] . teenage pregnancy presents significant health consequences to both mothers and newborns. complications in pregnancy and childbirth are the leading cause of death among girls aged - years globally [ ] . the risks are even higher for girls below the age of years. pregnant adolescents face a higher risk of eclampsia, endometritis and puerperal infections than women aged - years [ ] . in addition, adolescent births are more likely to result in preterm births, low birth weight and newborns with severe congenital conditions. furthermore, teenage pregnancy is a major contributor to a never ending cycle of ill-health and poverty [ ] . the impact of teenage pregnancy includes loss of education opportunities, early marriages, and economic disempowerment [ , ] . studies have shown that most teenage pregnancies occur among teenagers from deprived backgrounds [ , ] . therefore, all these factors result in the intergenerational transmission of poverty from the teen mothers to their children with poor ecd outcomes. the situation is bound to get worse with the covid- pandemic. furthermore, cases of gender-based violence, in particular, child and early marriages are also on the rise [ , , ] . it is well understood that children of teenage mothers tend to have poor ecd outcomes. the children have lower iqs and academic achievement, and are at a greater risk of repeating a grade. they are also at a greater risk of perinatal death and having a fatal accident before turning one year old [ , ] . the ministry of education announced that all schools within the territory of the republic of kenya shall remain closed until january [ ] . this announcement is worrisome given the increasing cases of teenage pregnancy during the extended period of schools' closure [ ] . the closure of daycares and pre-primary classes, which includes children up to four years, has affected children's access to early learning, that is, building their brains in a safe and stimulating environment and developing their social and emotional skills while their parents work. children learn best through play and interaction with peers; with daycares and other early learning centers closed, many children are not able to receive these critical inputs. these centers are also important sites for immunizations, meals and psychosocial support, all of which are being disrupted due to covid- [ ] . prior to the covid- pandemic in kenya, along with the rising urban population and the need for parents to find informal work, there was a growing demand for childcare and early learning services. high unemployment and literacy rates of parents, and the absence of extended family support and public amenities and the prohibitive cost of quality childcare services led families relying on informal childcare centers as they sought employment. there was a proliferation of relatively low-cost, non-regulated and informal privately owned childcare centers for children aged three years and below, commonly referred to as 'babycares' with at least of them in nairobi [ ] . these informal babycares are often home-based or faith-based and lack the minimum standards, expertise and infrastructure required to support children to attain their developmental potentials. some of these have poor lighting, are crowded with children that sleep most of the time, lacking play and stimulation and being served nutrient-poor or deficient foods. this large number is exacerbated by the lack of policy and legal framework to guide the services they provide for children below four years and their families. the national ecd policy framework of was not implemented due to operational issues [ ] . numerous conversations among stakeholders continue on the state of ecd for children below the age of four. with the nurturing care framework adopted in kenya, the focus on children below four years is taking center stage alongside the prioritization of programs and services to meet their needs. while nascent, at the beginning of covid- , there had been considerable traction. with the pandemic, these gains are threatened, as policy makers' focus and funds have been diverted to physical health, which includes preventing and treating those with covid- , rather than considering all aspects of child development. for middle-and upper-class families, they can hire childcare or early learning support, but this is out of reach for poor families. during the covid- pandemic and beyond, the kenyan government and other ecd stakeholders interested in ensuring that the youngest of children in the country are able to survive, thrive and continue on a positive life trajectory can reorient nurturing care. this is possible through utilizing the lens of direct health; health and nutrition systems; economic and social protection; and child development and early learning. children's needs are inter-related and holistic and so support must also possess these qualities. kenya has a number of policies and systems in place to bolster nurturing care during the covid- pandemic, but as is the case with many countries around the world, they are not fully financed and operational. actions to mitigate the negative impact on maternal, newborn, child and adolescent health need to be addressed by borrowing, developing, and implementing strategies utilized in previous epidemics and pandemics. this will guarantee continuity of care and avoid a rise in maternal and newborn morbidity and mortality. support to caregivers and families would enable them to nurture their young through a multi-sectoral approach that builds on existing programs [ ] . it is crucial to examine existing evidence on the direct effects of covid- on maternal and newborn care and develop programs that target easy access to maternal and newborn health services, warranting safety for mothers, children and health professionals following the guidelines. this could include increased bottom-up community health education and promotion strategies on the current covid- guidelines, utilizing a multi-sectoral approach through establishment of partnerships with community gatekeepers to teach mothers and caregivers. these strategies should be designed to be evidence-based and culturally appropriate, leading to holistic well-being for caregivers. particularly, families and caregivers of children with developmental delays and disabilities require targeted support that meets their needs during the ongoing crisis, enabling them to practice responsive caregiving through ensuring child safety and security [ ] . these children and those who are orphaned should be prioritized for social protection interventions implemented by both the government and development agencies. this support could include some or a combination of the following: cash transfers, food packs, mobile health and nutrition services, as well as regular support and monitoring by child protection teams. children with disabilities may experience stress, have underlying health conditions that increase their risk of complications from covid- , and may also be unable to access therapy during this period. similarly, their caregivers may have heightened stress. therefore, it is important to take care of their physical and mental health by improving access to community and home-based play spaces, therapy, health and psychosocial services, as well as other service navigation support. creatively delivering parenting education focused on enhancing caregiver capacities to become more responsive, promote maternal and child health and wellbeing, as well as adequate nutrition services will be at the core of driving nurturing care, and hence improving ecd outcomes. critical and essential health and nutrition, as well as other social services, can be delivered and sustained during the pandemic period with adherence to adequate infection prevention and control measures. furthermore, health education and promotion in addition to continuous engagement and referrals of caregivers and families through community health structures is crucial. innovative culturally acceptable strategies that transcend the existing pandemic barriers with a strong emphasis on strengthening community-based reproductive, maternal, newborn, child and adolescent health services are required. these services include family planning services; maternal nutrition such as promoting the uptake of iron and folic acid supplements; antenatal care; seeking skilled delivery and post-natal services; as well as essential nutrition services to support infant and young child feeding, routine growth monitoring and counselling through baby-friendly community initiatives. these should be further complemented with adequate transport to a health facility during curfew or lockdown situations. in some settings, health services are being taken to families in remote locations, especially those through mobile vans or clinics, thereby enabling greater and equitable nurturing care support for the youngest of children during the covid- crisis [ , ] . essential new-born care should be an area of sustained focus: early initiation and assessment for exclusive breastfeeding, addressing danger signs for referrals and timely linkages to health services. mothers and caregivers also need timely referrals and access to services for treatment of maternal and child undernutrition. integrated community case management of common childhood diseases, in particular malaria, diarrhea, pneumonia and malnutrition, should not be neglected. mental health, often overlooked, has risen to the consciousness of policy makers and donors. this pandemic provides an opportunity to take the innovations and expand mental health/psycho-social services throughout kenya. all people, young and old, are facing mental and emotional difficulties. caregivers juggling full-time jobs, caring for others such as the elderly and children at home, are feeling especially overwhelmed. development agencies are supporting families' mental health and psycho-social wellbeing where possible by establishing phone helplines to increase access to free professional mental health support. referral systems are also being established through these helplines, and this needs to be expanded and accessible. simple tips and exercises, relevant to both the young and old, are being broadcast on tv, radio, social media (facebook (facebook, inc., san francisco, ca, usa) or whatsapp (whatsapp inc., san francisco, ca, usa)) and through short videos. the design and utilization of mhealth can lead to improved ecd outcomes. in particular, the use of telehealth consultations where possible, with health professionals, can also help to minimize hospital visits. efforts should be made to scale up provision of nurturing care through integration into their health systems by adopting the mnurturingcare app in clinical encounters and at the community level [ ] . in addition, partnerships with the local communities are important to increase engagement and dialogue on the measures for supporting nurturing through heightened communication with health professionals who can offer prompt identification of complications and provide appropriate referrals. as covid- is negatively affecting the economic situation of many families in kenya, especially those who work in the informal sector and/or were already in precarious economic situations prior to the outbreak, innovative approaches such as cash transfers are necessary. in various emergencies around the world and in kenya, conditional and unconditional cash transfer programs have provided an economic safety net and positively impacted health during difficult periods such as the one we face [ ] [ ] [ ] . although the government has instituted social protection schemes in the form of cash transfers to cushion vulnerable families, the need is greater. more investments are required, particularly programs that support those who were previously working in the informal sector and have lost incomes. this can be achieved through reallocation of funds to social protection to increase the resources available for cash transfers and food supplies in order to mitigate socio-economic impacts, including addressing food insecurity [ , ] . these measures should be accompanied with the introduction of functional community mechanisms for identifying vulnerable households and children who lack access to basics such as food, water, shelter and healthcare, and provide targeted support. social safety nets for vulnerable families during this pandemic enable them to provide nurturing care to promote resilience among children, despite the stressors surrounding them. it is clear that many social and child protection services targeted at children and adolescents in kenya, such as meals and sanitary pads among others, have largely been delivered through childcare and school platforms; with school closures, this avenue is not viable. there is a need to build and leverage community level programs and policy support, targeting children at risk of abuse and neglect, and adolescents at risk of early pregnancy, to ameliorate the negative effects of the pandemic, such as poor nurturing care environments and transactional sex for food and pads among adolescent girls, all of which subsequently leading to poor child development outcomes. mitigation strategies should focus on safety nets for poor families in addition to identifying and supporting vulnerable children and adolescents within these families. urgent strategies are required to protect young children and girls from the increased gender-based violence during the pandemic period. these strategies include improved access to psychosocial support services through community agents or call-in centers to reduce caregiver stress, expansion of social and child protection services such as family tracing and reunification of separated or orphaned children, and increased delivery of reproductive health services through mobile reproductive health services and telemedicine in remote communities. for orphaned children, evidence indicates that family-based care is better for young children than institutional care [ ] . the landmark longitudinal study of romania's orphans led by the bucharest early intervention project showed that brain development can be severely affected when orphaned children are in institutional care without nurturing care [ ] . the study indicates that this effect can last over a person's lifetime. key stakeholders therefore should find safe and protective homes for orphaned children with other relatives and ensure they benefit from social and child protection services. this could also include conditional and unconditional cash transfers to help relatives of orphaned children that want to take care of them in supportive family environments. other critical community outreach strategies are also required to address poor nurturing care environments and rising transactional sex in partnership with nurses and community workers. these include expanding community outreach for nurturing care skills among caregivers and increasing access to sexual and reproductive health and rights education, as well as distribution of sanitary pads and contraceptives among adolescent girls. these strategies must be accompanied by facility and community-based youth-friendly reproductive health services. special attention needs to be given to the children of young teen mothers through social protection schemes to ensure that their children can achieve the highest developmental potential during this period. children and their primary caregivers/parents need social and educational support to ensure socio-emotional well-being, safety and security from violence and harm and opportunities to boost young children's brain development. children are separated from peers and extended family members such as grandparents, and are unable to attend early learning centers, daycares, and crowded areas. some children, just by being home, are exposed to domestic violence; early evidence points to an increase in such cases as stress levels of families' increase [ ] . concerted efforts including awareness raising are necessary to reduce violence against children. some innovations are being tested in this area by development agencies. for instance, the use of tv, radio, pre-made videos and social media to support early childhood educators, teachers, and family members with simple ways to support young children's learning and development at home has been observed. parents and caregivers are the most important support structure for young children, and their ability to nurture adequately while remaining physically and mentally healthy is critical. parents and caregivers should therefore become a critical target audience for ecd stakeholders in kenya and the region, ensuring that nurturing care becomes a family-centered with a whole-society approach. with the additional burdens being placed on parents and caregivers, they need to prioritize their physical and mental health. the strategies suggested above in the section on health and health systems support can be crucial. additionally, parents and caregivers also need practical tools and guidance to enable them to provide early nurturing care in the home environment, particularly providing opportunities for early learning as well as increasing community-led sanitation and nutrition programs. this includes strategies on how to regularly interact and communicate with children and provide them with age-appropriate play and learning resources at home, using locally available, low-cost or household materials easily found in their surrounding environment. the care for child development package is a useful intervention that can be cascaded widely, leveraging multi-sectoral community counselling platforms to encourage greater parental or caregiver responsiveness through communication and play [ ] . this will contribute to the healthy development and growth of children by supporting caregivers to build stronger relationships with their children and solve challenges in providing nurturing care. for those children who may have been attending babycares that have been closed due to the crisis, the caregivers need practical support to provide quality early learning in the home environment. linkages with child and social protection actors should be strengthened to promote nurturing care, as parents have now taken over childcare and schooling in the home while balancing dual roles of work and managing the household. in the critical early years, young children need at least one loving and trusted adult to feel secure, grow and develop holistically. in this period of adversity, children need nurturing relationships with caregivers and families to provide a buffer to counterbalance the hardships [ ] . covid- is still ravaging kenya and most of the world. there is still a lot to learn about what can work and what cannot. little research is currently published on how to support nurturing care for children under years in the wake of such a pandemic, especially in africa. while the impacts of the pandemic on the lives of young kenyan children and their families have been severe, and evidence around further impacts is coming to light, there are opportunities to learn and "build back better". interventions need to address five critical areas: direct health impacts, health and nutrition systems impacts, economic impacts, social and child protection impacts and child development learning impacts. there is need to leverage technology and use a community-based approach to support continuity of nurturing care services with timely referral and follow-up to a wide range of cross-sectoral services including psychosocial support. kenya has an opportunity to learn from other countries about how to develop practical and feasible guidance to reopen childcare centers and early learning spaces, given the low incidence of covid- in younger children. tailored plans are required for children with unique needs, and consideration should be given to provide holistic and inclusive support. the government and development actors need to consider increasing their investments to scale-up nurturing care through the development of policies and coordinated intervention programs during this pandemic period. this paper took stock of what we currently know about the impacts of covid- on nurturing care for the youngest kenyans, but this is just the tip of the iceberg. although our review paper has provided useful insights and made an important contribution to the body of knowledge, the key limitation is that it is mainly based on secondary sources including grey literature, and it did not rely on primary data. further primary research and investigation on the youngest children and the ability of children's ecology to provide nurturing care is needed, as is the further testing of new ideas. primary research is required particularly to explore the mental health impacts on caregivers and children; understand how domestic violence has impacted nurturing care; and shed more light on the experiences and support available to teenage mothers and caregivers of children living with disabilities. additional evidence would light the way forward for kenya and similar settings to ensure its youngest citizens can reach their full developmental potential. the authors declare no conflict of interest. first case of coronavirus disease confirmed in kenya; ministry of health the covid 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childhood; development and cooperation: frankfurt am main determinants of adolescent pregnancy in sub-saharan africa: a systematic review impact of covid- on children: special focus on psychosocial aspect domestic violence: the shadow pandemic risking the future: adolescent sexuality, pregnancy, and childbearing teenage children of teenage mothers: psychological, behavioural and health outcomes from an australian prospective longitudinal study kcse exams as covid- bites. daily nation we must mitigate teenage pregnancy crisis amidst covid- framework for reopening schools there are at least informal child daycares in nairobi-tiny totos is working to help them upgrade their services national pre-primary education policy; ministry of education the assessment of satisfaction with care in the perinatal period mobile health clinic model in the covid- pandemic: lessons learned and opportunities for policy changes and innovation health educator uses a mobile van to educate communities about covid- mthrive: a nurturing care app that supports community health workers. early chilhood matters cash transfer programs have differential effects on health: a review of the literature from low and middle-income countries the cash dividend: the rise of cash transfer programs in sub-saharan africa an emergency cash transfer program promotes weight gain and reduces acute malnutrition risk among children - months old during a food crisis in niger romania's abandoned children care for child development: an intervention in support of responsive caregiving and early child development. child care health dev key: cord- - rnvawfa authors: cousineau, j; girard, n; monardes, c; leroux, t; jean, m stanton title: genomics and public health research: can the state allow access to genomic databases? date: - - journal: iran j public health doi: nan sha: doc_id: cord_uid: rnvawfa because many diseases are multifactorial disorders, the scientific progress in genomics and genetics should be taken into consideration in public health research. in this context, genomic databases will constitute an important source of information. consequently, it is important to identify and characterize the state’s role and authority on matters related to public health, in order to verify whether it has access to such databases while engaging in public health genomic research. we first consider the evolution of the concept of public health, as well as its core functions, using a comparative approach (e.g. who, paho, cdc and the canadian province of quebec). following an analysis of relevant quebec legislation, the precautionary principle is examined as a possible avenue to justify state access to and use of genomic databases for research purposes. finally, we consider the influenza pandemic plans developed by who, canada, and quebec, as examples of key tools framing public health decision-making process. we observed that state powers in public health, are not, in quebec, well adapted to the expansion of genomics research. we propose that the scope of the concept of research in public health should be clear and include the following characteristics: a commitment to the health and well-being of the population and to their determinants; the inclusion of both applied research and basic research; and, an appropriate model of governance (authorization, follow-up, consent, etc.). we also suggest that the strategic approach version of the precautionary principle could guide collective choices in these matters. "during the past century, achievements in public health have led to enormous improvements and benefits in the health and life expectancy of people around the world" ( ). however, even now, at the dawn of the xxi st century, public health still faces important challenges. new zoonoses such as bovine spongiform encephalopathy (bse) ( ) or west nile virus (wnv) ( ) as well as new infectious diseases such as acquired immune deficiency syndrome (aids) ( ) or severe acute respiratory syndrome (sars) ( ) come easily to mind and provide good examples. moreover, the continuing and growing prevalence of chronic diseases such as cancer and diabetes also merits considerable attention. because many of these diseases are multifactorial disorders, the scientific progress in genomics and genetics must be taken into consideration in public health research ( , ) this approach, integration of genomics into public health, requires that we: "assess […] the impact of genes and their interaction with behaviour, diet, and the environment on the population's health. the promise of public health genomics is to have practitioners and researchers accumulating data on the relationships between genetic traits and diseases across populations, to use this information to develop strategies to promote health and prevent disease in populations, and to more precisely target and evaluate population-based interventions" ( ) . in short, "public health genomics uses population based data on genetic variation and geneenvironment interactions to develop evidencebased tools for improving health and preventing disease" ( ) . thus, genomic databases will constitute an important source of information, on the one hand, in order to pursue research aiming to understand better the genetic susceptibility to a disease regarding certain individuals within a population, and on the other, to implement eventually public health interventions. consequently, from this viewpoint, it is important to identify and characterize the state's role and authority on matters related to public health, in order to verify whether it has access to such databases while engaging in public health genomic ( ) research. then, is the mandate of our public health authorities adapted to the actual expansion of the genomic research domain? to answer this question, we first examine the evolution of the concept of public health, as well as its core functions, using a comparative approach (e.g. who, paho, cdc, and the canadian province of quebec) . following an overview of the essential roles of public health and an analysis of relevant quebec legislation, the precautionary principle is examined as another possible avenue to justify state access to and use of genomic databases for research purposes or, for the management of a pandemic. finally, we consider the influenza pandemic plans developed by who, canada, and quebec, which are key tools framing public health decision-making. they public health genomics is defined as : "the responsible and effective translation of genome-based and technologies into public policies, programs and services for the benefit of population". quebec is one of the ten canadian provinces. canada is a federal state where health is a shared jurisdiction. in public health matters, both the federal and provincial levels have some competencies. could illustrate the first steps in the evolutionary inclusion of genomics into public health. we think that this paper could help countries to examine their own definitions and legislations of public health to see if they contain provision that could form the foundation of the state powers to access genomic databases. the world health organisation (who) defines public health as "the art of applying science in the context of politics so as to reduce inequalities in health while ensuring the best health for the greatest number" ( ). despite the fact that who is the lead agency in health, up to now, no definition of public health has yet produced a general consensus ( ) . the notion is heterogeneous, depending on whether public health is defined in terms of objectives, methods, actors, or values. this can result in difficulties in assessing health in its collective dimension such as the contribution of various disciplines, of determinants of health and of various practices that are used in the development of health knowledge ( ) . the current trend for western countries is to adopt a broad definition ( ) . for example, the canadian institutes of health research define it as "the combination of sciences, skills, and beliefs that is directed to the maintenance and improvement of the health of all the people through collective or social actions" ( ) . this definition illustrates the importance of the collective dimension of public health measures and puts forward the idea that the concept of public health is constantly evolving. the american institute of medicine's committee for the study of the future of public health reminded us that the very substance of public health has expanded with the passage of time. indeed: "early public health focused on sanitary measures and the control of communicable disease. with the discovery of bacteria and immunologic advances, disease prevention was added to the subject matter of public health. in recent decades, health promotion has become an increasingly im-portant theme, as the interrelationship among the physical, mental, and social dimensions of wellbeing has been clarified" ( ) . for example, until quite recently, the vision of the quebec legislator concerning public health meant health protection and protection of the population's well-being. this observation is based in part on the evolving title of quebec legislation, which was changed from public health protection act (r.s.q., c. p- ; act abrogated april ) to public health act ( ). in adopting the public health act, the quebec legislator chose to implement a proactive rather than a defensive approach in order to respond to society's evolution and to knowledge about health determinants and therefore to encompass prevention, promotion and surveillance in the expression "public health" . along these same lines, article states: "[t]he object of this act is the protection of the health of the population and the establishment of conditions favorable to the maintenance and enhancement of the health and well-being of the general population". in this context, well-being is to the social sphere what health is to the medical sphere. it is a positive concept that goes beyond the absence of social problems and resembles the concept of quality of life. in fact, health and wellbeing are often linked ( ) . the who stresses that a growing understanding of various health determinants is transforming the assessment of public health ( ) . thus, in order for a public health system to adequately fulfill its function and keep up with advances in the discovery of health determinants, it must adopt a global approach to public health and define its components. indeed, "[s]uch an approach will when examining the bill in november , minister rémy trudel specified that more than just to ensure health protection in case of threat, the new law would also deal with prevention and promotions. help to ensure that the public health infrastructure covers all appropriate public health activities adequately and that it can function well in an increasingly complex and changing environment" ( ) according to the canadian institutes of health research, "[t]here is a critical need to reach consensus on the core essential functions of the public health system. it will not be possible to assess and develop a system infrastructure if these are not defined" ( ) . the study of essential functions of public health is helpful in understanding public health legislation, its functioning and the scope of its application; essential functions are "the set of actions that should be carried out specifically to achieve the central objective of public health: improving the health of populations" ( , ) . in effect, "in january , the who executive board recommended that work proceed on the concept as a tool for implementing the renewed [health for all] policy in the st century" ( ) . the regional office for the western pacific of who specifies that it is the responsibility of governments to define the fundamental missions of public health more precisely and systematically and to articulate them, without having the obligation to execute them and finance them ( ) . definitions of the main functions of public health, unlike broader definitions, address the need for the clarification of roles and responsibilities in the public health domain ( ) . in fact, a univocal definition of the field of public health is impossible; rather, referring to the missions and roles of the field would illustrate the actionbased character, the knowledge, and the areas of intervention in public health ( ) . although many categories and definitions of essential functions have been suggested, these categories and definitions are constantly evolving ( ) and are specific to each organization. interestingly, quebec's approach to public health, proposed in and still in force, refers to measures relating to the determinants of health and well-being at the population level and the systems, which govern them ( ) . these measures are delimited by the essential and the supporting functions of public health ( ) . in order to better understand the fundamental concept of public health, we drew up a table of the categories used by the québec public health program and compared them to those of the who, the pan american health organization and the national public health. a similar analytical approach has been proposed in quebec ( ) . according to lévesque and bergeron such a comparative analysis constitute an interesting basis for reviewing the roles of public health. the authors specify that the selected organizations seem to equate elements related to roles of public health (health promotion, prevention, etc.) with elements related to the type of intervention used (information, education, empowerment) as well as to the strategies used (social participation, partnership mobilization, legislation). furthermore, in terms of healthcare, they limit themselves to evaluating its quality and to the defense of access equality ( ) . similarly, other authors indicate that various functions defined by the american program, the who and paho have much in common, even though they demonstrate some specificities. studying quebec legislation, we retain the public health functions adopted by the provincial government. these are listed and defined in the québec national public health program program - . the program distinguishes core functions from support functions. thus, core functions include ongoing surveillance of the population's state of health; promoting health and well-being, prevention of disease, psychosocial problems, and trauma; health protection. as for supporting functions, they refer to the regulation, legislation, and public policies that can have an impact on health; to research and innovation; to the development and the maintaining of professional competencies. a more in-depth understanding of the functions of public health is susceptible to this echoes the population-centered approach that must guide public health according to provision of the public health act, r.s.q. c. s- . . provide a legal basis for public health legislation to allow access, by the state, to genomic databases for research purposes. the next section is therefore devoted to their definition. the ongoing surveillance function has two main objectives: to follow closely the evolution of the population's health status and of its determinants and to inform the public and those responsible for the planning, organization and evaluation of services, within and outside of the healthcare network of this evolution ( ) . included in this function are measures that delimit access to information, as well as those needed for the description and analysis of the population's health status and then for the distribution of this information to each targeted public ( ) . the ongoing surveillance function also encompasses vigilance, producing snapshots of health and well-being (sociomedical statistics), analysis of determinants, and finally, identification of vulnerable groups and of efficient interventions ( ) . it accounts for observed variations and tendencies, detects emerging problems, and elaborates prospective scenarios of health status and well-being, taking into account the natural evolution of problems, interventions and the change of determinants. it also implies communicating information on the state of public health and well-being to the population itself ( ) . ongoing surveillance thus differs from public health research. surveillance aims to support decision-making concerning the health and wellbeing status of a given population. research, as a source of new scientific knowledge is better characterized as a support function of public health (table ) . public health legislation and regulations. strengthening of public health regulation and enforcement capacity. enforce laws and regulations that protect health and ensure safety. **regulation, legislation and public policies that have an impact on health. public health management. development of policies and institutional capacity for health planning and management. develop policies and plans that support individual and community health efforts. human resources development and training in public health. assure competent public and personal health care workforce. **skills development and maintenance. quality assurance in personal and populationbased health services. evaluate effectiveness, accessibility, and quality of personal and population-based health services. personal health care for vulnerable and high risk populations. evaluation and promotion of equitable access to necessary health services. link people to needed personal health services and assure the provisions of health care when otherwise unavailable. research in public health. research for new insights and innovative solutions to health problems. **research and innovation. social participation in health. mobilize community partnerships and action to identify and solve health problems. occupational health protecting the environment * core functions ** support functions prevention specifically targets chronic diseases, trauma, and social problems having an impact on the health of the population (suicide, violence, drug addiction, etc.) this includes reducing risk factors, vulnerability, and early screening ( ) . prevention thus has a double objective: reducing risk factors for disease, psychosocial problems and trauma and detecting these problems before they become exacerbated ( ) . prevention can be carried out among individuals and at-risk groups by bolstering existing aptitudes, developing the acquisition of new skills, and practicing preventive care, including screening ( ) . protection refers to the collection, by public health officials, of information deemed necessary in preventing or responding to a dangerous situation; this information is to be collected from individuals, groups, and populations in the case of a real or anticipated threats to public health ( ) . a threat to public health occurs as stated by article , when there is the "presence within the population of a biological, chemical, or physical agent that may cause an epidemic if it is not controlled" ( ). in the case of a real or apprehended health threat, health authorities will act at the scale of either the entire population, groups, or individuals ( ) . health protection measures apply to harmful situations and particularly to biological, physical, and chemical aggressors, including the battle against sexually transmitted diseases and aids, workplace health, and environmental health ( ) . the compilation of information for epidemiological studies, in order to better determine the threat and implement measures to counter or assess the situation is authorized. medical observation by public health teams, established by article of the quebec public health act ( ) allows the discovery of threats to population health in real time ( ) . for the québec national public health program - ( ) , health promotion refers to actions supporting individuals and communities in their effort to exert better control over essential factors of health and well-being. these actions, while encouraging individual progress, emphasize social and political dimensions: supporting community action, developing public policies, and creating a (physical, cultural, social, economical, and political) environment that is favorable to health ( , ) . this is in line with article of the quebec public health act ( ), in virtue of which measures provided by the act are geared towards "exerting a positive influence on major health determinants, in particular through trans-sectoral coordination". thus, its aim is, from an ecological perspective, to facilitate the development of conditions favorable to health in the social and economic environment as well as in individual and collective behaviors ( ) . this includes interventions not only on lifestyle but also on the totality of health determinants and the development of conditions and environments that are favorable to health and well-being ( ). according to the québec national public health program - ( ) , this function involves identifying the problems and situations which call for a regulatory, legislative or policy-based solution in order to enhance or maintain the health of the population. it consists also in assessing the consequences of public policies for the population's health and recommending measures to reduce their negative effects on health; finally, it includes carrying out mandates related to the application of regulations, laws, or policies, which come under spheres other than public health in order to prevent certain health problems ( ) . overall, this function illustrates the support needed for the elaboration and application of laws and regulations, which have an effect on the health, and well-being of citizens ( ) . this support function demands the development and the maintenance of professional resources, expertise, and skills ( ) . of course, it includes the importance of evaluating the program's training needs in order to offer continuing education ( ) . as expected, "the research and innovation function includes all activities focused on the production, dissemination, and application of scientific knowledge as well as on innovation" ( ) . in short, this element refers to research needed to maintain and develop expertise for the implementation and evaluation of public health programs ( ) . if genomics research is a new tool in public health action, should not the research and innovation function be integrated into the core functions of public health as an important activity, thus enabling the state to achieve its public health objectives? in this respect, should state powers in public health allow access to databases for the purposes of genomic research? in this section of the paper, in order to understand the legislative powers and the possibility of research in genomics, the public health act ( ) is firstly examined and, secondly, the act respecting institut national de santé publique du québec ( ), which allows powers for public health research. an overview of the public health act is helpful to identify the powers of the state in the protection of public health. the act does not contain any specific provision regarding access to genomic databases for research purposes. it is nevertheless important to examine the different options laid out by the legislation. in fact, be it in the context of common practices related to public health, in an alert or in an emergency, the act establishes certain powers related to the collection or transmission of information necessary for exercising public health powers. within the framework of current practices related to public health, the public health act stipulates that public health authorities may collect information by means of registries or information and data collection systems. registries, which are established for the purpose of clinical preventive care or for protecting the health of the population, contain personal information on certain health services or health care received by the population ( ). the best example is the vaccination registry described at article ( ). data and information collection systems administered by public health authorities are divided into two categories. the first category refers to the system established by the minister of health and social services for the compilation of sociological and health-related personal or non-personal information on births, stillbirths, and deaths ( ). this system is not intended for genetic information. the second category refers to systems for the collection of data and personal and non-personal information on the prevalence, incidence, and distribution of health problems and in particular on problems having a significant impact on premature mortality and on morbidity and disability ( ). these systems could be used to investigate the prevalence of infectious diseases. these collection systems have been implemented within the framework of the ongoing surveillance entrusted exclusively to the minister and to public health directors (art. , par. ). ongoing surveillance is carried out in order to: ) "obtain an overall picture of the health status of the population; ) monitor trends and temporal and spatial variations; ) detect emerging problems; ) identify major problems; ) develop prospective scenarios of the health status of the population; a copy of the opinion of the ethics committee must then be forwarded to the commission. public health act, r.s.q. c. s- . , art. , par. . ) monitor the development within the population of certain specific health problems and of their determinants" (art. ). undoubtedly, points , and could be perceived by some as legislative basis for the creation of a data collection system of genomic information; nevertheless, ongoing surveillance, as prescribed by the act, is surveillance of the "health status of the general population and of health determinants so as to measure their evolution and be able to offer appropriate services to the population" (art. , par. ). ongoing surveillance does not apply "to research and knowledge development activities carried out in the sector of health or social services in particular, by the institut national de santé publique du québec" (art. , par. ). in addition, although the act stipulates that "[p]eriodic surveys on health and social issues shall be conducted to gather the recurrent information necessary for ongoing surveillance of the health status of the population" (art. ), the nature of such surveys leads us to believe that they cannot be used in the context of genomic databases. indeed, the act specifies that "[t]he carrying out of national surveys shall be entrusted to the institut de la statistique du québec created under the act respecting the institut de la statistique du québec (chapter i- . ), which shall comply with the objectives determined by the minister" (art. , par. ). conducting genetic susceptibility research is not equivalent to conducting statistical surveys. having established the lack of a legislative basis for genomic research by the state in the course of the normal practice of public health, and more specifically, in ongoing surveillance, would it be possible for other previously collected data to be used by the state for other purposes, such as genomic research? the public health act provides measures for monitoring public health and for ensuring proper transmission of information. four areas are outlined: reporting of unusual clinical manifestations associated with a vaccination (art. ); mandatory reporting of intoxications, infections and diseases (art. - ); notification of the public health director in the case where a person who is likely suffering from a disease or infection, subject to mandatory reporting, is refusing or neglecting to submit to an examination (art. ); alerting public authorities to health threats (other than those arising from a sexually transmitted biological agent) (art. - ). two areas outlined by the act are particularly relevant to our study: mandatory reporting of intoxication, infections, and diseases, and the alerting of public authorities to health threats. first, we ask ourselves if genetic susceptibilities should be included in the category of reportable intoxications, infections, and diseases pursuant to section. it is important to specify that "the list may include only intoxications, infections or diseases that are medically recognized as capable of constituting a threat to the health of a population and as requiring vigilance on the part of public health authorities or an epidemiological investigation" (art. ) . thereby: "with respect to the list drawn up pursuant to section of the act, the intoxications, infections and diseases that may be included for reporting to public health authorities must satisfy the following criteria : ( ) they either present a risk for the occurrence of new cases in the population, because the disease or infection is contagious, or because the origin of the intoxication, infection, or disease may lie in a source of contamination or exposure in the environment of the person affected; ( ) they are medically recognized as a threat to the health of the population, as defined in section of the act, which may result in serious health problems in the persons affected; ( ) they require vigilance on the part of public health authorities or an epidemiological investigation; and ( ) public health or other authorities have the power to take action in their respect to prevent new cases, to control an outbreak or to limit the magnitude of an epidemic, through the use of medical or other means" ( ) . genetic susceptibility does not satisfy these criteria; the above list enumerates diseases, rather than methods for the detection of disease akin to the detection of susceptible genes. secondly, government departments and bodies, local municipalities, health care professionals, directors of institutions must report threats, other than those that arise from a sexually transmitted infection, to the public health director (art. - ). given the current legislative framework, reporting "does not authorize the person making the report to disclose personal or confidential information unless, after evaluating the situation, the public health authority concerned requires such information in the exercise of the powers provided for" in the case of threat to the public health (art. ). a threat to public health occurs when there is the "presence within the population of a biological, chemical, or physical agent that may cause an epidemic if it is not controlled" (art. , par. ). therefore, in any situation where the public health director believes on reasonable grounds that the health of the population is or could be threatened, he may conduct an epidemiological investigation (art. ). where required within the scope of an epidemiological investigation, the public health director may: ) "require that every substance, plant, animal or other thing in a person's possession be presented for examination; […] ) take or require a person to take samples of air or of any substance, plant, animal or other thing; ) require that samples in a person's possession be transmitted for analysis to the institut national de santé publique du québec or to another laboratory; ) require any director of a laboratory or of a private or public medical biology department to transmit any sample or culture the public health director considers necessary for the purposes of an investigation to the institut national de santé publique du québec or to another laboratory; ) order any person, any government department, or any body to immediately communicate to the public health director or give the public health director immediate access to any document or any information in their possession; even if the information is personal information or the document or information is confidential; ) require a person to submit to a medical examination or to furnish a blood sample or a sample of any other bodily substance, if the public health director believes on reasonable grounds that the person is infected with a communicable biological agent"(art. , ). if certain authorities have powers to sanction the collection and transfer of biological samples or of personal information (held by a third party or by the individual concerned), is it conceivable that these powers could be used to sanction genomic research, for example research into genetic susceptibility to an infectious disease endangering the health of the population? in declaring a public health emergency, the government has extraordinary powers at its disposal. the declaration of a public health emergency in all or part of the territory of quebec will occur "where a serious threat to the health of the population, whether real or imminent, requires the immediate application of certain measures to protect the health of the population" (art. ). the government or the minister (if he or she has been so empowered) may, notwithstanding any contrary provisions, order any person, government department or body to communicate or provide immediate access to any document or information held, even personal or confidential information or a confidential document, in order to protect the health of the population (art. , par. ( )). the state of emergency is considered so paramount that "[t]he government, the minister or another person may not be prosecuted by reason of an act performed in good faith" (art. , par. ). unless such "emergency" information is available and workable, genomic research will not be possible due to time constraints; the research would take too long before results could determine which measures to adopt. if the government has extraordinary powers at its disposal, we consider that they are inappropriate in this research con-text. in fact, such information should already be accessible under these powers. not only does the public health act not expressly permit research in public health, but also, our analysis leads us to conclude that these provisions do not give appropriate powers to the state to access genomic databases for research purposes. on the other hand, because the act respecting institut national de santé publique du québec ( ) already gives certain powers for research into public health, it seems appropriate to examine whether this act presents a new avenue to explore. the institut national de santé publique du québec (inspq) was established to contribute to the development, consolidation, dissemination and application of knowledge in the field of public health (art. , par. ( )) and also to develop and promote research in the field of public health in collaboration with the various research organizations and funding bodies (art. , par. ( ), ). a review published by the inspq also notes that research into the health and well-being of the population and its determinants seeking to produce, integrate, disseminate and apply scientific knowledge to the exercise of public health functions, belong to the field of public health research ( ). knowing this, could the inspq initiate fundamental research in genomics? this would present a challenge since the government of quebec prioritizes applied research over fundamental research in public health ( ) . on this matter, the inspq states that basic research, the results and applications of which are not expected in the short or medium term have been excluded from for example, are considered as public health research activities research related to the surveillance of a population's health status and well-being; on the relationship between a population's health status and wellbeing and its determinants; on intervention and on promotional, preventive and protective programs aimed at maintaining and improving the health and well-being of a population; on public policies related to a population's health and well-being the field of research in public health, while applied research was included ( ) . if all legislative texts examined here do not create an explicit power to access and use genomic databases for research purposes, we can ask ourselves if it is possible to invoke the precautionary principle to legitimate a state power allowing this type of intervention. is there a clear definition of the precautionary principle? the framework for the application of precaution in science-based decision making about risk ( ) outlines guiding principles for the application of precaution to science-based decision making in areas of federal regulatory activity regarding the protection of health, the environment, and the conservation of natural resources. the concept of precaution is presented as resting on the notion that the absence of full scientific certainty shall not be used as a reason for postponing decisions where there is a risk of serious or irreversible harm ( ) . formalized in international environmental law, the precautionary principle was incrementally introduced into the domain of public health . spe- the precautionary principle has not been explicitly integrated in the provincial (quebec) and international public health legislations. see: loi sur la santé publique, l.r.q., c. s- . ; international health regulations ( ), art. ( )d) and c). however, both the programme national de santé publique ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) , which identifies public action that provincial (quebec) authorities must put into place until year , and the report of the review committee of the functioning of the international health regulation ( ) cifically, we can emphasize its use in food safety. its direct applicability was explicitly recognized by the european court of justice, notably in the case of the embargo on british beef during the mad cow crisis ( ) . the principle has also been recognized as an important risk management tool in the context of pandemics. in france, as in canada, it was prominent in the reports of commissioners appointed to inquire into the tainted blood scandal and the sars crisis ( ) ( ) ( ) . three fundamental components of the precautionary principle are outlined: the lack of full scientific certainty, the risk of serious or irreversible harm and the need for a decision ( ) . the first two elements are criteria for the application of the principle, whereas the third determines its normative scope. however, these application parameters establish standards that cannot be determined objectively, and are therefore subject to different interpretations. for example, concerning scientific uncertainty, the level, and threshold of scientific knowledge on potential risk, required to apply the principle, is unclear . in the same line of thought, the severity or the irreversibility of the potential harm cannot always be evaluated solely by objective scientific criteria ( ) . furthermore, the conceptual "the response of who and many countries to the pandemic was a reflection of this mindset. this was affirmed in the sentiments expressed by many member states to the review committee: in the face of uncertainty and potentially serious harm, it is better to err on the side of safety. public-health officials believe and act on this conviction. it is incumbent upon political leaders and policy-makers to understand this core value of public health and how it pervades thinking in the field". to this effect, we cite the krever's report on contaminated blood as well as judge campbell's report on sars in canada, in addition to commissioner legal's report in france. this question constitutes one of the most important problems faced by the doctrine with regards to the application of the principle. one can wonder whether theoretical knowledge is enough or if it is necessary to support the hypothesis of risk by empirical data. it is also important to question the degree of consensus needed within the scientific community, so that a scientific hypothesis is regarded plausible. framework of the third element, the need for a decision, does not anticipate the nature or the scope of the precautionary measures, leaving the authorities with a margin of discretion. different interpretations of the precautionary principle resulting from the articulation of these three key elements have been developed and reviewed in the literature ( ) . indeed, the precautionary principle is a concept of "variable geometry" ( ) . it has a malleable character; the definition and its impact on the decision making process vary according to the context of application. there is no strict consensus on this issue. a typology of the precautionary principle permits an examination of interpretations in line with our primary objective, which is to legitimate a state power allowing access and use by the authorities of genomic databases for research purposes and to see if, for this end, it is possible to invoke the precautionary principle. the first two versions, "the institutional model" and "the cautious approach", can be qualified as antagonistic . they are based on the proportionality and the severity of the precautionary measures adopted. the institutional model promotes early action that is proportionate to the potential risks. the cautious approach, instead, calls for the implementation of more demanding precautionary measures and favors eradicating risk. in its extreme form, the cautious approach constitutes the rule of abstention or prohibition. the institutional model was recognized by justice krever in the tainted blood report ( ) . he stated that additional precautionary measures, such as heating blood products and screening of blood donors to reduce the risk of hiv transmission via blood products should have been taken at an earlier point in the crisis. the cautious approach, which favours eradication of risks, can be associ- the articulation of these three elements leads to differences regarding the measures adopted, the precocity of the application of the principle, etc., as well as its normative character (ethical principal or legal etc.). with the exception of antagonistic versions, it is possible for precautionary measures adopted by authorities to stem from different interpretations of the principle. ated with the implementation of quarantine measures once fatalities occurred (e.g. efforts to counter the threat of sars). the third and fourth versions of the precautionary principle, the "tactic approach", and the "strategic approach" deal with the timeframe of the enactment of precautionary measures. according to the tactic approach, precaution is a temporary and flexible instrument; uncertainty is thought to dissipate with knowledge. the tactic approach operates in the short and medium term. thus, measures are provisional and revisable, subject to change in response to increased knowledge. the tactic approach, used in the area of food safety, is associated with moratoriums, embargos, and all other reversible measures ( ) . in the specific context of pandemics, quarantine measures could also serve as an example of this particular interpretation. the strategic approach relates to the vorsorgeprinzip, a legal concept developed in germany, which inspired the creation of the precautionary principle. the strategic approach is premised on the notion that obtaining scientific certainties cannot always be done in time to allow for guidance of collective choices. its proponents argue that a policy of prevention based on medium and longterm objectives should be adopted. thus, attention should be shifted from advances in the understanding of risks, to understanding the evolution of the technological and economic resources available for risk prevention (i.e. the invention of new and substitute treatments, etc.) ( ) . among the different versions discussed above, this final version, the strategic approach, could legitimate power authorities to use genetic databanks for research purposes and to utilize their findings in the context of public health interventions. the implementation of surveillance systems and pre-authorized procedures illustrate measures corresponding to this approach. recently, the possibility of a pandemic caused by the avian influenza mobilized the forces of many international and national public health bodies. various surveillance mechanisms were recommended. it would be particularly interesting to verify whether these governing bodies, in the elaboration of their intervention plan, intend to take advantage of the field of genomics, and if so, in which manner they plan to do it. our analysis of the pandemic influenza recommendations proposed by the world health organization, canada and quebec, all of which are important planning instruments, centers on the four principal functions of public health: monitoring, promotion, prevention and protection. the emergency issue is dealt with separately to accentuate the characteristics of this specific context. canada's and quebec's plans emphasize the responsibility of governments in the risk management of pandemic influenza. the world health organization's influenza preparedness plan ( ) has had a significant impact on the design and on the implementation strategies of the canadian and quebec plans. the canadian pandemic influenza plan ( ) can be studied in parallel with the new quarantine act ( ) . the purpose of the act is to prevent the introduction and spread of communicable diseases (art. ). it specifically addresses the screening of travelers or conveyances leaving and entering canada (art. ). by definition, a pandemic affects several countries. public health measures at the borders will therefore be crucial in preventing and controlling outbreaks. precise details concerning various types of data to be collected and the roles and responsibilities of individuals at the local, provincial, territorial and federal levels can be found in the canadian plan, and specifically in the pandemic influenza surveil-lance guidelines ( ) . the document also outlines the responsibility of canadian officials towards the world health organization. a number of factors are likely to influence the nature of surveillance measures. in addition to the various phases and periods of a pandemic, which shape the surveillance objectives and officials roles, the guidelines recommend considering changes in circumstances and new information ensued. this approach requires attentiveness to any development or variation in multiple areas. in particular, all aspects of a disease or of the epidemiology of the infection will require special attention: clinical manifestation (case definition and pathogenesis of influenza), virulence, mode of transmission, incubation period, period of transmissibility, and its effect on the population (distribution and frequency of the disease). could this latter aspect possibly include the need for population genomic data on gene-environment relationships? in addition to the recommendations of the pandemic influenza surveillance guidelines ( ) , annex c of the canadian plan sets out recommendations concerning the virological monitoring and laboratory tests and procedures ( ) . the annex c is not as explicit as the surveillance guidelines on the subject of research studies. nonetheless, annex c institutes a context of investigation and information updates for laboratories by addressing certain test protocols as well as communication between stakeholders. apart from citizens and health professionals, communication and health promotion tools are also intended for a third category of persons: politicians. any information regarding the influenza pandemic would certainly be valuable in guiding different public health authorities (public health directors, ministers, governments). the annex on communication in the canadian plan describes national objectives of communication in detail and according to pandemic periods ( ) . the plan favors transparency and stakeholder responsibility in risk communication. the canadian plan thus strives to ensure that up-to-date information about a situation and risks for society are transmitted to the political authorities concerned ( ) . a large portion of the canadian plan deals with functions linked to prevention and protection. for instance, guidelines on public health measures set out recommendations on education and communication of information to the population, community measures, such as school closures and public assembly limitations, and the care and services to be offered to persons infected by the new influenza virus and to their contacts ( ) . our analysis of the annexes of the canadian plan concerning prevention and protection demonstrates two guiding ideas in the elaboration of recommendations: updating the information to be used for public health interventions, but also, in parallel, maximum use of existing expertise in devising scenarios and hypotheses of an influenza pandemic in canada. annex l of the canadian plan, entitled federal emergency preparedness and response system, outlines the federal government's responsibilities in the area of public health, particularly the powers conferred to the public health agency of canada and health canada. this annex does not include a definition of "emergency" per se, but the concept is elucidated by the examples provided. from these examples, we can infer that emergencies share the following characteristics: severity, need for immediate action, and a large number of people affected. the examples listed include sars, the ice storm of , nuclear emergencies, pandemic influenza and "events or catastrophes of natural origin or deliberately caused". similarly, to its federal counterpart, the québec pandemic influenza plan -health mission ( ) serves as a reference document in preparing for an influenza pandemic. its implementation will take into account new epidemiological knowledge of pan-demics and the overall evolution of the situation ( ) . the québec plan proposes participation methods for all susceptible individuals in the event of a pandemic influenza, including decision-makers, citizens, informal caregivers, and workers. with respect to this participation, "three rules of governance" are provided as guiding principles: protection, solidarity, responsibility, and sound management. as the authors point out, the three rules of governance "are interdependent and have the common condition that everyone be vigilant as to their own state and the state of others and act accordingly" ( ) . the government of quebec, in partnership with political and health authorities, has a responsibility to protect the lives and health of the population, and more generally, its well-being ( ) . the québec plan reflects this complex objective in distinguishing five broad facets of state intervention: "protecting the health of the population (public health); providing medical care (physical health); ensuring people's psychosocial well-being (psychosocial response); providing clear, relevant and mobilizing information (communication) […] [, and] keeping the network working (continuity of services)" ( ) . our analysis of the québec plan continues in light of the public health ethics committee's study of this document. the public health ethics committee was created by the public health act. as mentioned, "scientific activity" plays a significant role in controlling pandemic influenza ( ) . yet, although the need to obtain the best knowledge possible and to adopt the most effective measures is evident, other documents fail to mention scientific activity. this acuteness with regards to knowing about ones own health status is now coupled with a traveller's duty to disclose their suspicion that they have or might have a communicable disease listed in the schedule or are infested with vectors as provided by law: quarantine act, s.c. , c. , art. . this disclosure shall be done to a screening or quarantine officer while crossing the country's border and this without waiting to be questioned by the officer. we must point out; however, that "scientific activity" is an area that can have significant demands. these demands lead us to question whether the collection and analysis of genetic or genomic information can be pursued as a means of obtaining the best public health intervention strategies . influenza control plans only refer to genetics under the label of "scientific information". for example, though the canadian plan mentions the impact of "information from the viral genome" ( ) , no direct or indirect mention is made of genomic information as it relates to information concerning individuals or group of people. the same observation is true for the québec plan ( ) , and that of the world health organization ( ) . nevertheless, the obligation to protect the population in the event of a pandemic places an incumbent responsibility on different levels of government to implement measures to attain this objective. could genomic research programs be a part of these measures? after having examined different definitions and legislations regarding public health particularly in the canadian province of québec to see if they provide the basis to allow the state to access genomic databases, we offer the following conclusion. we must admit that genomics, or more specifically, genomic susceptibility to disease, offers interesting avenues for action in public health. in a not too distant future, genomics may well become a health determinant ( ) . in fact, in quebec, biological and genetic predispositions, lifestyles and other health-related behaviours, living conditions and social settings; physical environment and finally, organisation of health and social we note that the public health ethics committee opinion does not mention genetic nor genomic information. the consideration of its inclusion among scientific activities is ours. services as well as access to resources ( , ) are considered health determinants. nonetheless, we have observed in the paper that state powers in public health, are not, in québec, well adapted to the expansion of genomics research. currently in canada, in the absence of emergencies, states powers to access genomics databases for research purposes are not explicitly and clearly established. however, to the extent that it can be shown that the genomic can be a very useful tool to respond more efficiently to a crisis in public health, should the state not take into account this new field of knowledge? the influenza control plans by highlighting the important responsibilities incumbent upon states to implement effective interventions in a pandemic, and by recognizing the contribution of knowledge and research, promote an open approach toward public health genomics. this leads us to make an important recommendation. in the future, the scope of the concept of research in public health should be clear and include the following characteristics: a commitment to the health and well-being of the population and to their determinants; the inclusion of both applied research and basic research; and, an appropriate model of governance (authorization, follow-up, consent, etc.). medium and long-term objectives should be adopted in relation to the possible future use of research results for public health interventions (public health promotion, prevention, and planning). therefore, we propose that the strategic approach version of the precautionary principle, based on premise that scientific certainties cannot always be obtained in a timely manner, could guide collective choices in these matters. as an autonomous discipline, public health deals with the global health of populations in all its curative, preventive, and social aspects; its objective is to develop systems and initiatives of health promotion, prevention, and treatment of illnesses, and rehabilitation of handicaps ( , ) . as mentioned, the concept of public health is far from being static; it demonstrates a flexibility that guarantees a perpetual adaptation to new forms of risks attributable to the determinants of health. on the one hand, this flexi-bility is a consequence of the evolution of the notions of health, well-being, and illness, which are recognized as multifactorial phenomena. on the other hand, it is the result of developments in informational and biomedical technologies ( ) . as such, the flexibility of public health may allow it to embrace new research tools, such as genomics. however, how can this innovative tool be utilized to reach the public health objectives of protection, prevention, promotion, and surveillance? in order to insure its appropriate use, it is essential to take into account the state's powers and responsibilities and to decide on the most suitable model of governance for this new biomedical research asset. interestingly enough, world health report no health without research ( ) will discuss the impact of research in the elaboration of effective and efficient policy options, recognizing that, unfortunately, health policies are often not well-informed by research evidence. as stated, "the theme was selected in part to meet who's core function of stimulating the generation, translation and dissemination of valuable knowledge" ( ) . keeping in mind that, in april , the who department of research policy and cooperation established the who initiative on genomics & public health ( ), it will be fascinating to find out the importance given to genomics. ethical issues (including plagiarism, informed consent, misconduct, data fabrication and/or falsification, double publication and/or submission, redundancy, etc) have been completely observed by the authors. getting ready for the future: integration of genomics into public health research, policy and practice in europe and globally understanding the bse threat mad cow update: risk now limited Étude d'impact stratégique du plan d'intervention gouvernemental de protection de la santé publique contre le virus du nil occidental west nile virus: don't underestimate its persistence learning from sras -renewal of public health chemokine (c-c motif) receptor - genotype in patients receiving highly active antiretroviral therapy: race-specific influence on virologic success committee on genomics and the public's health in the st century -board on health promotion and disease prevention -institute of medicine of the national academies years of public health genomics at cdc - the path from genomebased research to population health: development of an international public health genomics network le risque comme problème politique: sur les obstacles de nature politique au développement de la santé publique. revue française des affaires sociales de l'individuel au collectif: une vision décloisonnée de la santé publique et des soins. ruptures, revue transdisciplinaire en santé la santé publique au québec à l'aube du xxi e siècle. santé publique the future of public health in canada: developing a public health system for the st century committee for the study of the future of public health -division of health care services regional office for the west pacific, provisional agenda item (document wpr/rc / ): essential public health functions: the role of ministries of health, regional committee, fifty-third session, kyoto (japan) public health in the americas: conceptual renewal, performance assessment, and bases for action redefining the scope of public health beyond the year essential public health functions: results of the international delphi study les fonctions essentielles de santé publique : histoire, définition et applications possibles. santé publique québec public health program québec, institut national de santé publique du québec et ministère de la santé et des services sociaux pan american health organization national public health performance standards program -the essential public health services programme national de santé publique - , version abrégée. québec, direction des communications du ministère de la santé et des services sociaux Éthique et santé publique : enjeux, valeurs et normativité. les presses de l'université laval framework for the application of precaution in science-based decision making about risk uk/commission krever commission report, ottawa, public works and government services canada the sars commission -spring of fear: final report. government of ontario le développement durable contre le principe de précaution le principe de précaution comme norme de l'action publique, ou la proportionnalité en question. revue économique le principe de précaution dans le contexte du commerce international : une intégration difficile pandemic influenza preparedness and response: a who guidance document her majesty the queen in right of canada, canadian pandemic influenza plan for the health sector pandemic influenza surveillance guidelines in her majesty the queen in right of canada, supra, note , annex n (date of latest version pandemic influenza laboratory guidelines in her majesty the queen in right of canada, supra, note , annex c (date of latest version canadian pandemic influenza plan for the health sector: communications annex in her majesty the queen in right of canada, annex k (date of latest version quebec pandemic influenza plan -health mission volet santé publique du plan québécois de lutte à une pandémie d'influenza -mission santé, avis adopté à la e séance du comité d'éthique de santé publique, le juin les défis de la santé au xxi e siècle: approche législative des déterminants de la santé santé publique : santé de la communauté population health in canada : a systematic review. canadian policy research networks secrétariat du comité d'éthique de la santé publique -ministère de la santé et des services sociaux world health report the initiative on genomics & public health the authors want to thank genome canada, genome québec and the social sciences and con humanities research council of canada for their financial support. the authors declare that there is no conflict of interests. key: cord- -naz vct authors: rostal, melinda k.; olival, kevin j.; loh, elizabeth h.; karesh, william b. title: wildlife: the need to better understand the linkages date: - - journal: one health: the human-animal-environment interfaces in emerging infectious diseases doi: . / _ _ sha: doc_id: cord_uid: naz vct wildlife are frequently a neglected component of one health; however, the linkages between the health of wildlife and human, domestic animal, and environmental health are clear. the majority of emerging zoonotic diseases are linked to wildlife, primarily driven by anthropogenic land changes. despite this risk, wildlife have important links to people as environmental indicators, food security and safety, and through human livelihoods. this chapter will describe these linkages and demonstrate the need to understand these linkages through targeted surveillance and understanding the ecology of wildlife diseases. while the management of wildlife diseases presents a significant challenge, such practices will greatly improve the health of people, domestic animals, wildlife and the environment. one health is the all-encompassing concept that recognizes the inextricable links between the health of people, animals (wild and domestic), and the environment. while the link between people and domestic animals is well recognized, as they have been used for food, work, and products for millennia, the link between the health of people and wildlife is often neglected. this may be due to a perceived distance between wildlife and people and a lack of understanding of the important linkages that unite human health with the health of all animals. in an ever more urbanized and globalized world, the distance between people and wildlife is shrinking and these linkages are becoming ever more evident. in this chapter, we will discuss the linkages between human health and wildlife from multiple perspectives. this includes direct linkages with human health, such as emerging and nonemerging zoonotic diseases, as well as linkages between wildlife health and the environment, food security and the health of domestic animals, and sustainable human livelihoods. wildlife are an important component of one health, but is often neglected due to difficulty in conducting health studies and limited data and funding. we will further discuss the importance of understanding these linkages with wildlife through targeted surveillance, understanding the ecology of wildlife diseases, and the management of wildlife diseases. when wildlife are discussed in the context of one health, it is frequently in terms of their role as hosts to emerging infectious diseases (eids). with the number of eids significantly increasing during the past years, recent work has demonstrated that the majority are zoonotic ( %) and approximately % of those are of wildlife origin (jones et al. ). an eid is frequently defined as a disease that has recently been jumped into a new host, has evolved a new pathogenicity, is increasing in incidence, or has expanded into a new geographic range (lederberg et al. ; jones et al. ) . while outbreaks of eids may seem like rare events, as a group they cause hundreds of thousands of deaths annually (bogich et al. ) and a single event may cost us$ - billion to the global economy (newcomb ) . the process of disease emergence is complex and often multifactorial, but it can be better understood using broadscale, ecological approaches in identifying these factors, or drivers. in the first attempt to classify the underlying drivers of disease emergence, the institute of medicine (iom) identified six factors including: human demographics and behavior; technology and industry; economic development and land use; international travel and commerce; microbial adaptation and change; and breakdown of public health measures (lederberg et al. ) . in , seven additional drivers were added to the iom report including: human susceptibility to infection; climate and weather; changing ecosystems; poverty and social inequity; war and famine; lack of political will; and intent to harm (smolinski et al. ). iom's classification of the ''factors in emergence'' largely paved the way for current research investigating the underlying drivers of infectious disease emergence. it is important to note that these drivers are not mutually exclusive, and that factors may act in concert and will vary at different stages of the emergence process. for example, anthropogenic land use change has resulted in cross-species transmission of disease or initial emergence, from animal hosts to humans both directly by increasing human contact with animal populations, and in other cases indirectly by changing vector populations (daszak et al. ; patz et al. ) . climate and weather can augment these affects and modulate outbreak size; particularly with vector or waterborne diseases, and global trade and travel has facilitated the spread of those diseases (hufnagel et al. ). these eid drivers function on a different scales, vary geographically (keesing et al. ) , and can be attributed to a combination of environmental, ecological, political, and social forces. despite ongoing research investigating the role of eid drivers, additional studies and modeling approaches are needed to more fully understand the complex mechanisms of emergence (bogich et al. ). one important driver of zoonotic disease emergence that has often been overlooked by the one health community is the wildlife trade. trade in wildlife, both legal and illegal, can lead to the introduction of zoonoses and/or foreign animal diseases that may impact domestic animals or native wildlife species (karesh et al. ) . the illegal wildlife trade is estimated to be approximately us$ billion, the second largest black market after narcotics (karesh et al. ) . it is likely that this estimate is overly conservative as a recent study found that within one tropical country, venezuela, - million animals are traded annually at an estimated cost of us$ million (asmüssen et al. ). an estimated . billion live wild animals were legally imported into united states between and . nearly, % of those animals were destined for the pet trade (smith et al. ). with the magnitude of stressed, and possibly immune compromised, wild animals being transported on a global scale, it is not surprising that this has resulted in the spread and transmission of diseases that affect native wildlife, domestic animals, and people. previous outbreaks of important zoonotic diseases have already been attributed to the wildlife trade; notable, among these in the twenty-first century are severe acute respiratory syndrome (sars) and monkeypox. sars is a novel coronavirus that shifted from bats into civets and humans causing severe morbidity and mortality (case fatality rate of . - . %) (donnelly et al. ) . globalization and airline networks expidited the spread of sars from its point of origin in southern china to infect people in countries, making it the first pandemic of the twenty-first century (zhou and yan ) . the ''wet market'' where sars emerged in guangzhou, china had stalls where wild mammals, domestic animals, reptiles, and birds were sold in conditions of poor hygiene and in close proximity. after the sars outbreak was traced back to these markets, the chinese government reportedly confiscated , wild animals (karesh et al. ) . the most likely scenario of initial spillover and emergence was that rhinolophid bats harboring a sars or sars-like coronavirus were kept in cages in close proximity to civets that contracted and amplified the virus in the markets (li et al. ) . however, the evidence demonstrating bats as the original natural reservoir of sars-like coronaviruses was not discovered until years after the initial outbreak (li et al. ; field ). ongoing research has now revealed large numbers of novel coronaviruses from bats, and the hypothesis of sars originating from these hosts has been further validated (woo et al. ; yuan et al. ) . monkeypox emerged under similar conditions through the legal pet trade in the us in . it is hypothesized that prairie dogs (cynomys spp.) were in contact with a shipment containing gambian rats (cricetomys spp.) and african dormice (graphiurus spp.) at a wholesale pet store. the prairie dogs became ill, as did people in contact with them (guarner et al. ) . despite the serious threat of eids from wildlife in the legal and illegal trade, few international programs exist to screen imported wildlife for pathogens of concern. a recent study analyzed wildlife products confiscated by the us customs and border protection at john f. kennedy airport in queens, ny as well as seizures from airports in philadelphia, washington, dc, houston, and atlanta . smith et al. ( ) detected simian foamy virus (sfv) and several herpesviruses from bushmeat samples, including nonhuman primates, e.g., chimpanzees (pan troglodytes), mangabeys (cercocebus spp.), and guenons (cercopithecus spp.), that were imported from guinea, liberia, and nigeria. while sfv has not yet been shown to be pathogenic in people, approximately % of bushmeat hunters in close contact with dead primates were found to be infected with sfvs (wolfe et al. ) . wolfe et al. ( ) demonstrated sporadic transmission of sfvs to humans, and offered a better understanding of how human immunodeficiency virus/acquired immunodeficiency syndrome (hiv/aids) may have emerged from primates. we know that simian immunodeficiency virus (siv) jumped several times into people hunting and consuming nonhuman primates before mutating into the pandemic hiv strains that are now circulating (heeney et al. ). this recent work by smith et al. ( ) demonstrates that zoonotic pathogens can be transported in bushmeat and potentially could cause an outbreak in a location far from its endemic region, underscoring the need for better port surveillance and regulation of this trade. left unregulated, legal and illegal wildlife trade can potentially have a large impact on human health, as well as direct impacts on wildlife and domestic animal health (discussed below). the health of wildlife is closely linked to the health of the environment and can be extremely sensitive to anthropogenic changes. this includes direct physiological and behavioral responses to chemicals and pollution as well as competition and other effects from the introduction of nonnative wildlife and/or new pathogens. animals have long been used as indicators of a toxic environment. the proverbial ''canary in a coal mine'', as later memorialized by sting in a song, stems from the use of canaries to detect trace amounts of methane and carbon monoxide in mines since the early s. their death indicated to miners that they needed to evacuate the mine to prevent asphyxiation. dichlorodiphenyltrichloroethane (ddt) was one of the first global acknowledgments of chemicals affecting nontarget animals. ddt was found to reduce the eggshell thickness of multiple bird species (porter and wiemeyer ) . it was later discovered that bioaccumulation of the chemical through the trophic levels had devastating effects on the populations of certain top predators and insectivorous birds (e.g., raptors such as peregrine falcons (falco peregrinus) and bald eagles (haliaeetus leucocephalus) (grier ) . these effects became widely distributed by rachel carson's ''silent spring'' (carson ) and wildlife and plants were increasingly recognized as important indicators of man-made environmental health threats. during the s, the us environmental protection agency (epa) began using ecological risk assessment (in addition to human risk assessment) to evaluate the risk of agrochemicals or other manufactured chemicals, superfund sites, as well as air and water pollution (epa ) . ecological risk assessment depends on scientific assessment of the risk a chemical poses to a wide variety of plants and animals, including invertebrates, fish, birds, and small mammals (epa ). while the system continues to be improved, risk assessments have been important in identifying the detrimental effect of acid rain (beamish ), perfluorinated chemicals ( van de vijver et al. ) , and most recently endocrine disruptors (kloas and lutz ) . these ecological risk assessments have contributed to several us national environmental laws that were created to protect the health of people. in addition to top predators, small mammals are frequently used in ecological risk assessments and have been proposed as sentinels for heavy metal contamination. talmage ( ) suggests that small mammals make good indicators of environmental pollution because of their abundance, widespread distribution, short dispersal distance, generalized food habits, short life span, high reproductive rate, and relative ease of capture. in particular, they can be used to assess the environmental contamination of landfills and mine areas (torres et al. ) . insectivorous mammals appear to be the best indicators as they are exposed more directly through invertebrates that may consume soil (e.g., earthworms) (hamers et al. ) . in particular, small mammals have been used successfully to assess cadmium, fluoride, lead, and mercury exposures (talmage ) . one relatively recent study found that both rodents and children living around a mining site in mexico had nearly twice the levels of lead and arsenic as the respective controls from the reference site (jasso-pineda et al. ) . despite the many studies that have successfully demonstrated that various rodent species can be used as environmental indicators for heavy metals and chronic pollution and the frequent use of rodents in risk assessments for new chemicals on the market, rodents are rarely used for regulatory purposes (e.g., for long-term monitoring of mining sites) (handy et al. ) . when used appropriately, environmental indicators could be a very valuable tool in long-term monitoring of the risk of pollution and contamination of both terrestrial and aquatic habitats (lam and gray ; jasso-pineda et al. ) and should be utilized more frequently. as with zoonotic eids, emerging diseases of wildlife have increased during recent decades (daszak et al. ) and have frequently been linked to anthropogenic ecological changes. specifically, it is likely that trade, travel, invasive species, and poor biosecurity measures are driving many of these diseases. we highlight this with two emerging fungal pathogens that have caused devastating impact on two vertebrate groups, chytrid fungus in amphibians and white-nose syndrome (wns) in bats, with indirect one health consequences for human health and food security. during the late twentieth century, amphibian populations began to decline on a global scale (heyer et al. ; young et al. ) . chytridiomycosis (batrachochytrium dendrobatidis; chytrid fungus) was determined to be the causative agent in many of the declines (daszak et al. ) . this fungus caused multiple species declines (even local extirpation of multiple amphibian populations in some areas) in pristine habitats in the americas and australia (daszak et al. ) . it is believed that the chytrid fungus was spread through the trade of african clawed frogs (xenopus laevis), the original host, and the north american bullfrog (rana catesbeiana) (weldon et al. ; schloegel et al. ). r. catesbeiana is frequently raised and traded for food, with greater than , kg of this species sold within brazil every year (schloegel et al. ). it has been suggested that out of more than species of amphibians noted to be rapidly declining due to enigmatic causes (stuart et al. ), a significant portion of them may have been due to chytrid (skerratt et al. ). this fungus demonstrates how seemingly unrelated anthropogenic actions (wildlife trade) can have far-reaching effects on the environment and wildlife. additionally, the loss of amphibians may disrupt ecological processes, such as a reduction in predation on mosquito larvae, resulting in consequent indirect impacts on human or animal health. wns is an emerging disease of hibernating bats caused by the fungus geomyces destructans (blehert et al. ; lorch et al. ) . it was first documented in the us in , and was most likely introduced accidentally by people traveling to and from europe, where it is ubiquitous and causes no bat mortality (puechmaille et al. ). this cold-loving fungus thrives in the winter environment of bat hibernacula and disrupts the hibernation and physiology of over-wintering bats. bat mortality is frequently attributed to starvation and dehydration as the infection causes arousal during the winter leading to the depletion of the fat reserves of the hibernating animals (cryan et al. ; reeder et al. ). the fungus grows on the muzzle and wing membranes of susceptible bats. mortality rates at many hibernacula are extremely high, commonly in the range of - % (turner et al. ). wns has rapidly spread south and west across the us, being confirmed in us states and four canadian provinces; and by early , the us fish and wildlife service estimated that over . million bats have died from the disease. wns is predicted to cause the local extirpation or possibly the extinction of the little brown bat (myotis lucifugus), which was once the most populous bat in the us (frick et al. ) . once a wildlife disease such as wns is established, control becomes very difficult. researchers are currently working to understand the environmental and life-history variables that allow the fungus to persist and spread, with hopes that areas or microclimates can be set aside for management intervention ahead of the epidemic wave (boyles and willis ; wilder et al. ; langwig et al. ) . other unproven solutions being developed include antifungal treatment, maintaining rescue captive breeding colonies, and artificially heating caves. wns, like chytrid, is an introduced fungal pathogen and arguably they are two of the most significant wildlife diseases-threatening a wide range of species with possible ecological and global extinction (fisher et al. ) . the value of bats in control of agricultural pests in north america alone has been estimated to us$ . billion annually, with a loss of bats translating into increased production costs (pesticides and other pest control methods) and smaller crop yields (boyles et al. ). as introduced above, food safety and security is an important component of one health, especially as the fao estimates that . billion people are undernourished worldwide (fao ) . wildlife is linked with food security as wildlife can contaminate foodstuff with zoonotic diseases, bushmeat is a major protein source for people living in many tropical countries, and wildlife and domestic animals can share significant pathogens. foodborne illnesses pose a serious threat to public health with growing economic and international trade ramifications. standard epidemiological public health methods are frequently used to investigate foodborne outbreaks among people. however, foodborne diseases are good examples of the intricate link between human and animal populations, and the surrounding environment. in , a virulent strain of e. coli o :h was linked to spinach and affected approximately people in states (cdc ) . a typical epidemiological investigation of this outbreak would have extended only to human morbidity, mortality, assessments of risk and probable source, laboratory diagnosis, and clinical treatment. however, when domestic and wild animal health and ecology were considered, warnert ( ) found the same strain of e. coli o :h isolates that caused the human outbreak in wild pig feces, the feces of several cows, and in a stream on one of the four spinach farms in the area. thus, a one health perspective integrating our knowledge of epidemiology, clinical diagnostics, the environment and ecology, was required to fully investigate and understand this outbreak and has great utility in understanding the foodborne illness outbreaks. foodborne pathogens from wildlife span the taxonomic spectrum from helminthes to viruses. emerging foodborne diseases represent the majority of foodborne illnesses in the us and an even larger percentage of the foodborne illnesses are likely due to yet undescribed pathogens (tauxe ) . many of the known foodborne pathogens and up to % of foodborne eid events are zoonotic and many may be linked to wildlife. commonly, both wild and domestic animals are implicated as sources of food contamination (beuchat and ryu ; doyle and erickson ; newell et al. ; gorski et al. ; cima ) . despite this, definitive identification of a specific source animal or species is rare, particularly as epidemiological investigations often occur long after the index case, as it can take time for an outbreak across various states or counties to be detected. however, in some cases, detailed ecological studies can determine the exact route of food contamination from wildlife. for example, nipah virus, a bat-borne emerging encephalitic paramyxovirus, is primarily transmitted through contaminated date palm sap in bangladesh. with annual outbreaks in people and very high fatality rates ([ %), this is a pathogen of special concern (luby et al. (luby et al. , . recent serological and pathogen discovery studies have shown that pteropus giganteus, a large fruit bat, is likely the primary reservoir for this virus (epstein et al. ) . further, using techniques of wildlife surveillance and infrared camera traps, the exact mechanism of transmission was determined. bats were observed feeding from date palm sap collecting pots at night and currently specific interventions that do not entail bat eradication are being developed to prevent this transmission (nahar et al. ; khan et al. ). wild animals provide a substantial portion of our food globally, with nearly half of all seafood coming from wild sources. in some regions of the world, wild meat from terrestrial animals represents a primary source of protein on which people are dependent. the volume of wild meat (''bushmeat'') harvested from central africa alone totals more than billion kg per year (wilkie and carpenter ) . this volume of meat, almost all of which is processed and distributed to consumers with few if any modern hygiene practices, provides a constant opportunity for human exposure to both rare and common foodborne pathogens (karesh et al. ; smith et al. ). modeling has been used to indicate direct linkages between health and bushmeat consumption. golden et al. ( ) used generalized linear mixed-model regression to suggest that if bushmeat were removed from the diet of children in madagascar, hemoglobin concentration would decrease by . g/dl leading to a likely increase in anemic children of nearly %. the overconsumption of wildlife resources may soon lead to the loss of bushmeat protein to diets. fa et al. ( ) predict that the percentage of dietary protein consumed through bushmeat is unsustainable and will decrease from an estimated % in to % by in the congo basin. this prediction is based on increasing wildlife extraction to production ratios that will ultimately lead to a decline in wildlife abundance. without the availability of bushmeat or the redistribution of global food sources, food insecurity in this region is likely to increase. this link between bushmeat hunting and food insecurity has been supported by the results of a study, which found the alleviation of food security concerns of villagers in zambia by improving domestic animal production over years led hunters to turn in , snares and firearms, saving an estimated , wild animals (lewis and jackson ). wildlife can be reservoirs of important diseases of domestic animals, some of which were originally diseases of livestock and are now maintained in wildlife populations despite eradication of the disease in domestic animals. diseaseinduced morbidity and mortality in domestic animals as well as economic sanctions associated with the presence of certain diseases can adversely affect the supply of food animals. certain wildlife diseases can cause morbidity and mortality in domestic animals that are accidental or dead-end hosts. one such example is malignant catarrhal fever, caused by alcelaphine herpesvirus of wildebeest (connochaetes taurinus), which can cause acute mortality in cattle (russell et al. ). while its significance is limited to regions endemic for wildebeest (or zoos housing them), outbreaks of the virus can cause significant losses and hardships for local herders in africa. some diseases have larger economic ramifications, such as foot-and-mouth disease (fmd). though the virus affects all species with cloven hooves (order: artiodactyla), there are specific strains that are more likely to circulate in different geographic locations and possibly primary reservoir species (e.g., cattle or african buffalo, syncerus caffer) (klein ). while the virus is not highly fatal to the animals, trade restrictions to prevent the introduction of the virus in fmd-free regions has led to it becoming an economically important virus. it is estimated that during the fmd outbreak in the uk, losses to agricultural industry and the food supply chain amounted to £ . billion (thompson et al. ) . outbreak response led to the destruction of million animals (thompson et al. ) . it is likely that the virus was imported into the country from cattle in virus endemic regions (samuel and knowles ) . some diseases of concern have their origins in domestic animals, but have now been established into wildlife populations where they can then be retransmitted back to domestic animals (daszak et al. ). in the us, brucella abortus is generally believed to be introduced to the continent by cattle (meagher and meyer ) . after a successful eradication campaign, all states were declared free of brucellosis in domestic cattle herds in ; however, the maintenance of the bacteria in herds of elk and bison in the greater yellowstone area has allowed the pathogen to persist and continue to cause outbreaks. the debate over how to eradicate brucellosis from the country is ongoing. management methods that have been discussed include: test and cull, depopulation, and prohibiting winter feeding sites for elk as well as vaccination (olsen ) . a similar story follows the introduction of bovine tuberculosis (mycobacterium bovis) into wildlife hosts (see box ). one health includes considering pathogens originating from domestic animals that can severely affect wildlife. rinderpest virus was introduced into africa during the early s. the virus swept across the continent killing susceptible cattle and wild artiodactyls en masse. it has been reported that over . million cattle died in southern africa and up to % of the african buffalo population was decimated (plowright ) . fortunately, rinderpest was not able to be maintained in large wildlife populations without the presence of cattle (plowright ) . it is believed that the massive loss of multiple species of grazers (buffalo, wildebeest etc.) actually led to a change in the ecosystem of the region that is still in effect today, although as these species are recovering, the ecosystem is likely reverting to that which was believed to have been prior to the outbreak (holdo et al. ). rinderpest is now the second virus that has been eradicated through the use of vaccinations, after smallpox virus (yamanouchi ) . box . bovine tuberculosis: a persistent linkage between wildlife and domestic animals wildlife reservoirs of domestic animal diseases can make it exceedingly difficult or even impossible to eradicate economically important pathogens. often, diseases that originated in domestic animals persist in wildlife at such low prevalences that they are not detected in the wildlife until the disease is controlled or eliminated in domestic animals. in the us, a program to eliminate bovine tuberculosis (mycobacterium bovis; btb) was initiated in . by , every state had been declared to be free of btb (knust et al. ) , when a case of btb was reported in a white-tailed deer (odocoileus virginianus; wtd) in michigan. the outbreak was confirmed after of hunter-killed deer tested positive for btb (schmitt et al. ) . genetic analyses have confirmed that this strain of btb has been circulating in the wtd population at a low prevalence (o'brien et al. ) . efforts by the michigan department of agriculture and michigan department of natural resources (mdnr) initially focused on depopulation of wtd in the -county affected area and a ban on feeding or baiting deer during winter. while they have been successful in decreasing the prevalence by %, low levels of btb ( . % prevalence) continue to circulate in the wtd and occasionally spillover into cattle, leading to depopulation of the cattle herd (o'brien et al. ) . the circulation of btb in wildlife has a high economic cost to agriculture in the region as michigan now has a splitstate tuberculosis accreditation (the upper peninsula of michigan is still considered tuberculosis free, while the rest of the state is divided between accredited free, modified accredited advanced, and modified accredited, depending on the distance from the nidus of btb. it is estimated that btb and the accreditation change cost michigan's agriculture industry us$ million from to and us$ million from to (thiel ) . eradication of btb in the wtd population has been prevented partially due to the lack of public support for continued lethal population control. hunters contribute us$ million to michigan's economy and with other sympathetic electorate, who desire to view deer in their yards, have significant political clout (o'brien et al. ) . political pressure to decrease the level of lethal control has lead the mdnr to look to developing new vaccine-related technologies. while no such vaccine has yet been developed, pressure continues to mount as wtd in minnesota were found to have btb (most likely a cattle strain) following outbreaks in cattle in (knust et al. ) . several other wildlife species are known to be reservoirs of bovine tb in countries beyond the us, making it very difficult to eradicate globally. (o'brien et al. ) . bovine tuberculosis demonstrates the difficulty of sustainable control of a zoonotic and economically costly disease. the challenges of either eradication or control in wildlife also highlight the cost-effectiveness of prevention, i.e., investment in efforts to prevent domestic animal diseases from becoming established in wildlife populations would be more cost-effective and more less effort than trying to remove a pathogen from wildlife populations. many of the most biologically diverse regions coincide with human populations living at the highest poverty levels. as people raise themselves out of poverty, they can provide their families with better medical care, leading to better health. one proposed method of community development for improving livelihoods and health is the sustainable use and conservation of wildlife. an important component of ensuring sustainable use of wildlife is engaging all of the relevant stakeholders, especially the people living around the conservation areas whose livelihoods can be directly impacted by wildlife. people living in areas with free-ranging wildlife are frequently in conflict with wildlife, e.g., crop raiding. the sustainable use of wildlife can lead the community to accept the risks of coexisting with wildlife to support conservation and the health of the natural ecosystem. ecotourism has been defined by many different groups, here we will use the same definition as stronza and pêgas ( ) -nature tourism that intentionally seeks to deliver net positive contributions to environmental conservation and sustainable development for local communities. this definition links conservation directly with the health and development of the local communities. this concept aims to harness resources from the ever-growing tourism industry (walpole and thouless ) . for example, in kenya wildlife tourism grossed nearly us$ . billion in tourism-related industries in , with . million visitors to parks and game reserves (knbs ) . that amount of earnings contributes significantly to the national economy. however, despite the significant earnings from wildlife-based tourism and safari hunting, the equitable distribution of the funds is important in achieving the sustainability of wildlife resources. the success of ecotourism can be evaluated by measuring local economic benefits and participation as well as conservation indicators. there are many factors that may contribute to the success or failure of ecotourism, including: the presence of a flagship species, the biodiversity index and ease of viewing wildlife, the popularity of a particular location, the attitudes and current livelihood of the local communities, the perceived risk of wildlife to the community (e.g., crop raiding, disease, safety, or competition with, or consumption of domestic animals), and the perceived cost of living near the protected area (e.g., loss of access to cultivable or grazing land, watering holes, and inability to hunt) (walpole and thouless ) . a recent analysis of perceived cost from villages around kibale national park, uganda suggested a distinct geographical variation in households with perceived loss compared to those with perceived benefit. households within . km of the park boundary perceived the highest losses, while benefits were perceived up to km from the boundary (mackenzie ) . salafsky et al. ( ) worked with local communities to establish and support business operations and evaluate them with financial, social, and conservation indicators. they found that community participation in an operation was significantly linked to conservation success, even if the focus of the operation itself was not involved in conservation, such as the example from zambia discussed earlier where snares were turned in. interestingly, few operations were able to cover their costs after years and those that did required strong management systems to remain financially viable (salafsky et al. ) . in particular, creating successful community-based ecotourism programs can be very difficult given the competition and the high cost associated with start-ups in resource poor areas. it can take several years before such operations are able to cover their costs and it is not always clear that benefits for human health will trickle down from these operations (kiss ; walpole and thouless ) . few projects have successfully linked wildlife conservation directly to health care, although there are a few examples of large-scale initiatives seeking to do so. in the qomolangma national nature preserve in tibet, a collaboration among the villages, government, and various ngos led to the training of local villagers to protect the nature preserve with the benefits being improved access to basic health care. several individuals from local villages were educated in: preventative health care, distribution of medicines, environmental protection, ecotourism, poverty reduction, and income generation. these trainees provide services and education to the villagers. the success of the program was measured by a doubling of the estimated wildlife populations in the preserve, a decrease in logging by two-thirds, a decrease in the incidence of diarrheal diseases, and a reduction of infant mortality by % (melnyk ; taylor-ide and taylor ) . rarely mentioned in one health publications, discussions, or meetings is the topic of anthropozoonoses-diseases transmitted from humans to animals. much of the original literature on this subject area comes from studies with nonhuman primates, especially the great apes. butynski ( ) provides an extensive review of anthropozoonotic risks to great apes, including measles, herpesviruses, poliovirus, mycobacterium tuberculosis, sarcoptes scabeii, and a number of intestinal parasites. one survey found that % of tourists visiting sepilok orangutan rehabilitation centre in sabah, malaysia reported having one or more symptoms of an infectious disease while they were visiting the center (muehlenbein et al. ) . it has long been recognized that human tuberculosis (m. tuberculosis) can infect nonhuman primates. standard practices for captive nonhuman primates include routine testing of both the nonhuman primates and people who have contact with them (e.g., zoo keepers). interestingly, there is genetic evidence that suggests m. tuberculosis is significantly older than strains found in domestic livestock (m. bovis). it has been hypothesized that m. bovis evolved from an existing human pathogen or a common ancestor (brosch et al. ) . this is consistent with evidence of human tuberculosis preceding the to , -year-old domestication of animals (gutierrez et al. ) . excluding anthropozoonotic diseases from one health discussions alters the discourse to a narrow anthropocentric view of the world. the prevention of transmission of human diseases and improved human health can provide simple and cost-effective methods to protect wildlife from anthropozoonotic diseases. the linkages discussed above clearly indicate that wildlife health is intricately tied to the health of people, domestic animals, and the environment. despite these linkages and their key role as reservoirs of human eids, global efforts for wildlife health surveillance are lacking and underfunded. wildlife health surveillance can be used to better understand the pool of pathogens that may spillover into people or domestic animals; it can also be used to track the spread of wildlife diseases through populations. this surveillance can be used to investigate the ecology of the pathogen and hosts, which in turn can facilitate the prevention and control of important diseases. frequently, responses to emerging disease outbreaks are reactive and costly (childs and gordon ) . surveillance based on disease-specific control programs has successfully mobilized financial resources and delivered short-term results against disease-specific objectives (oliveira-cruz et al. ) . however, some have criticized this approach for focusing exclusively on a single disease and failing to reduce the risk of most pandemics (oliveira-cruz et al. ; travis et al. ). further, pathogen-specific surveillance often lacks sustainability and cannot be scaled-up, as benefits and outcomes are generally limited to the target area and funding cycle (oliveira-cruz et al. ) . to better target wildlife surveillance, there are several factors that need to be considered including geographic risk of emergence, the host species of the greatest concern for zoonotic spillover, and transmission pathways. the initial work to identify geographic ''eid hotspots'' found that countries with high biodiversity and human density are at the greatest risk for outbreaks (jones et al. ). most of these hotspots are located within developing countries, which often lack the infrastructure to conduct wildlife surveillance, either active or passive, and the ability to conduct diagnostic assays for rare or new diseases. one example of a multinational effort is the usaid predict project (see box ), which is based on initiating wildlife surveillance and investigating viral diversity in wildlife in these geographic hotspots. as zoonotic disease surveillance in wildlife clearly represents a great challenge (i.e., there are , + mammal species globally), predictive modeling and known patterns in host range can be used to focus the effort on the species and pathogens that pose the greatest risk of zoonotic emergence. new tools may make it possible to predict general patterns of host range in unsampled hosts, given known patterns from the past years of the published literature, knowledge of a species ecological and life-history traits, and some measure of surveillance or sampling bias from both a host and disease perspective. initial reviews of the literature were largely descriptive and grouped host species at higher taxonomic levels (e.g., ungulates, carnivores, rodents, and nonmammals) (cleaveland et al. ; woolhouse and gowtage-sequeria ; woolhouse and gaunt ) . more recent studies have tested patterns of pathogen-host range in a more mechanistic way, by explicitly including information on phylogenetic relatedness, although these studies are usually limited to a single host group or pathogen, e.g., bats and rabies (streicker et al. ) ; primates (davies and pedersen ) ; and fish ectoparasites (krasnov et al. ; poulin ) . similar approaches are currently being used to look at patterns of zoonotic disease emergence for all known mammal viruses and to test mechanistic drivers of cross-species viral emergence (bogich et al. ) . another useful way to focus surveillance efforts, speed up early detection, and reduce the risk of cross-species transmission is to target transmission pathways at specific human-animal interfaces. a key advantage of this approach is that surveillance efforts and control measures for one route of transmission should also mitigate a number of infectious diseases sharing the same transmission pathway. a multipathogen approach targeting disease transmission routes would be a useful way to target pathogen surveillance and control. it may also effectively focus prevention efforts, achieve early detection, and reduce additional risk of transmission. box . the usaid predict project: establishing a global wildlife surveillance network the predict project is part of the us agency for international development's emerging pandemic threats program. this project is developing a global wildlife virus surveillance system in countries that are in geographic hotspots (jones et al. ) in the amazon basin, mexico, southeast asia, and china, the gangetic plain, and the congo basin. this active surveillance system is aimed at understanding the importance of various human-wildlife interfaces. based on phylogenetic modeling, rodents, bats, and nonhuman primates were selected as target taxa due to their higher likelihood of harboring zoonotic pathogens (olival et al., unpublished data) . specifically, the project is targeting bushmeat sold in markets, wildlife that is collected by hunters, and wildlife living in proximity and/or conflict with people. predict is also investigating how changes in land use (using a landscape development index) can affect biodiversity and viral diversity of wildlife across a gradient of urban areas, rural areas with forest fragmentation, and in areas of pristine forest. this project works within each country's infrastructure to build surveillance and diagnostic capacity. viral discovery is conducted using degenerative primers to target viral families of zoonotic importance, which is then confirmed through genetic sequencing. in addition, deep sequencing methods are being used to discover new viruses. this diagnostic method maximizes the likelihood of discovering viruses, instead of targeting specific pathogens that may not be present. the predict project is standardizing surveillance methods across the globe to target potentially zoonotic viruses before they spillover. it is an example of combining high-level modeling with on-the-ground field data to target a surveillance system to efficiently detect potential pandemic viral threats. understanding wildlife diseases necessitates a multidisciplinary team, including epidemiologists, ecologists, and medical professionals. the ecology of the reservoir hosts as well as other competent species can be used to target disease management and mitigation (see box ). the importance of this is clear when considering pathogens such as ebola virus, where we have only recently discovered the probable reservoir (leroy et al. ), yet often cannot trace the transmission events from bats to nonhuman primates and/or people. further, new surveillance is finding evidence for ebola-like viruses in natural mammal reservoirs (e.g., bats and primates) well outside of their previously known range in africa (nidom et al. ; olival et al. unpublished data) . these recent findings point to a more urgent need to implement general, not pathogen-host specific, strategies to prevent zoonotic disease spillover from wildlife, i.e., by targeting transmission pathways or specific groups of hosts as were mentioned above. highly pathogenic avian influenza a/h n is a good example of the importance of understanding the ecology and epidemiology of a zoonotic disease in wildlife. this strain of avian influenza was first diagnosed in people in and in subsequent outbreaks has had an observed case fatality rate up to % (kandun et al. ) , although seroprevalence data indicate that it may be as low as - % (li et al. ) . when a/h n spread into europe and africa in there was an immediate reaction and assumption that it was transported by migrating birds, despite the lack of data at that time. the role of wild birds in the transmission and maintenance of a/h n remains controversial. outbreaks of a/h n in wild bird populations have occurred in isolation of poultry outbreaks and caused severe morbidity and mortality in some species. more than , birds at qinghai lake in china died during an outbreak, % of which were bar-headed geese (ansar indicus) (chen et al. ) . similar outbreaks occurred in mongolia and europe, indicating that there is occasional long-distance transmission by migratory birds (alexander ) . the effectiveness of longdistance transmission varies by species, as some species are severely affected by a/h n and others may be nonclinical shedders (based on studies in domestic mallards) (sturm-ramirez et al. ) . modeling by kilpatrick et al. ( ) suggests that the spread of a/h n may be a combination of the trade of poultry, the commercial trade in wild birds and transmission through migratory birds. their model suggests that the spread throughout asia was primarily due to poultry trade, and the spread in africa was partly due to poultry trade and partly due to migrating birds and the spread in europe was most likely through migrating birds. however, transmission by migratory birds appears to be rare, as proposed by gilbert et al. ( ) , who suggest that wild birds stopping over in areas at high risk for poultry strains of a/h n may occasionally transmit the virus via migration. a lack of sufficient information on the frequency or likelihood of spread through migratory birds indicates that further surveillance of a/h n should be conducted to better understand the transmission dynamics. without further ecological and epidemiological studies on the dynamics of a/h n , wild birds may have continued to be blamed for the maintenance of a/h n . it is known that waterfowl can be a mixing vessel for various subtypes of avian influenza (hatchette et al. ) , and it is rational to assume that they are the reservoir for a/h n . however, the seroprevalence of the h subtype is low in apparently healthy wild water bird populations (kang et al. ) . analyses of epidemics of a/h n in thailand found a strong association with the presence of free-grazing domestic ducks (gilbert et al. ) . additional analyses by gilbert et al. ( ) suggest that the presence of domestic ducks is the main factor associated with risk of a/h n in south asia, while human population and chicken density were also associated. recent modeling suggests that moderately sized flocks of poultry could maintain transmission of a/h n , whereas isolated small flocks or large commercial flocks are unlikely to maintain the virus (hosseini et al., unpublished data). thus, ecological studies of a/h n in both wild and domestic birds will continue to be important in understanding the maintenance of this virus. box . vulpine rabies: the importance of understanding ecology for control of rabies in europe vulpine rabies was first introduced to poland in and has since radiated out through eastern and western europe (anderson et al. ) . passive surveillance of wildlife throughout europe found that red foxes (vulpes vulpes) represented % of all wildlife diagnosed with rabies (who ) . attempts to control the fox population through culling did not succeed at preventing the spread of rabies, which expanded at an annual rate of - km. several papers in the early s illustrate the need for approaches and models that combined research on the viral pathogenesis, fox ecology, mapping of the development of epidemics, and importantly, the contact rate between foxes (anderson et al. ; macdonald and bacon ) . the social structure and density of foxes in some urban areas (five foxes per kilometer) would require a culling rate of - % to have a high probability of eliminating rabies (smith and wilkinson ) . culling adult foxes leaves empty territories that are quickly filled by dispersing yearlings and other young foxes. additionally, cub production is density dependent; thus, if culling were to decrease the population, more susceptibles would be introduced into the system as the reproductive rate of foxes would increase (macdonald and bacon ) . vaccination has been demonstrated to be effective in parts of europe and has two major advantages over culling: ( ) immunity decreases the likelihood of contact between two susceptible foxes and ( ) the reproductive rate remains stable, preventing the surge of susceptibles that follows a decrease in fox density (macdonald and bacon ) . for point-source infections, such as what would happen if rabies was introduced into britain, culling is more likely to be successful than in areas where rabies is endemic, especially as control efficacy may vary according to season (smith and wilkinson ) . the current control method for britain is to cull foxes within km of the point source followed by a ring of vaccine bait to prevent escape (smith ) . the ecological and epidemiological theory behind the development of control strategies for rabies in foxes can be transferred to other similar systems. in developing countries, the domestic dog remains the primary rabies reservoir. research in india has shown that trap, vaccinate (with or without sterilization), and release programs have led to a decreased number of rabies cases in humans, and may have led to a decrease in the stray dog population as well (reece and chawla ) . understanding the ecology of rabies in foxes and other carnivores has lead to a significant decrease in human rabies cases. wildlife are elusive, and have different ownership and custodian status among states and countries, and are often perceived in a variety of ways (emotional, religious, cultural, or utilitarian, etc.) by the general public; all of which necessitates new methods of disease control that consider the whole ecosystem including human interactions. artois et al. ( ) recently wrote a review of methods for controlling disease in wildlife and the risks associated with these methods. the primary goals of control are to limit the number of susceptibles or to treat/eliminate infected individuals to limit infectious period. lethal control and vaccination are the primary methods available to limit the number of susceptibles. lethal control, or culling, has frequently been shown to be very difficult to maintain in large populations of wildlife with high reproductive or immigration rates and is increasingly considered socially unacceptable (caughley and sinclair ) . further, culling is generally not a viable option when dealing with outbreaks in rare or endangered species, and the act of culling itself actually increases the human-wildlife contact interface and potential transmission of zoonoses. vaccination is increasingly being considered as a control option and is predicted to be the most efficient method to control hosts with relatively low reproductive rates. however, the production of a vaccine that is efficacious, stable in the environment, and easily deliverable (frequently orally) makes vaccination a difficult control method (artois et al. ). in addition, most effective wildlife vaccines (e.g. for rabies) are modified live vaccines that have the potential to harm nontarget species. another possible control method is fencing or other physical barriers to prevent direct contact. this is being recommended to farmers in michigan and minnesota as a method to prevent btb transmission from wtd sharing feed or entering cattle lots (palmer et al. ). low-tech bamboo skirts are also being used to keep bats out of date palm sap harvest areas to prevent the transmission of nipah virus (nahar et al. ). however, fences and barriers can sometimes interrupt nontarget species as well as the local ecosystem, e.g., in southern africa where fences prevent the migration of large herbivores, such as elephants (loarie et al. ). innovative methods of wildlife disease management will continue to be needed, especially as diseases emerge in difficult to manage species such as wns in bats. one health links the health of humans with that of domestic and wild animals and the environment. in this chapter, we have explored various linkages that connect wildlife health to human and domestic animal health. wildlife are linked to people through the risk of pathogen spillover, food security and safety, changes in the environment, and a human dependence on wildlife for livelihoods. each of these linkages can have positive and negative effects; e.g., human and wildlife transportation can increase the risk of spreading an emerging disease in either population; zoonoses may be balanced by the effects of anthrpozoonoses (though little research has been done to determine this); wildlife are a vital protein or income source for some human populations and can be responsible for food contamination or income loss for others. a better 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in asia acknowledgments we would like to acknowledge the generous support from our funders for this work. including the us agency for international development emerging pandemic threats predict project, a niaid nonbiodefense emerging infectious disease research opportunities award r ai - , an nih/nsf ''ecology of infectious diseases'' award from the john e. fogarty international center ( r -tw ). key: cord- -nrhe aek authors: shah, kaushal; mann, shivraj; singh, romil; bangar, rahul; kulkarni, ritu title: impact of covid- on the mental health of children and adolescents date: - - journal: cureus doi: . /cureus. sha: doc_id: cord_uid: nrhe aek the coronavirus disease (covid- ) outbreak was first reported in wuhan, china, and was later reported to have spread throughout the world to create a global pandemic. as of august th, , the coronavirus had spread to more than countries with at least , , confirmed cases, resulting in , deaths globally. several countries declared this pandemic as a national emergency, forcing millions of people to go into lockdown. this unexpected imposed social isolation has caused enormous disruption of daily routines for the global community, especially children. among the measures intended to reduce the spread of the virus, most schools closed, canceled classes, and moved it to home-based or online learning to encourage and adhere to social distancing guidelines. education and learnings of . % of students are impacted globally due to coronavirus in countries. the transition away from physical classes has significantly disrupted the lives of students and their families, posing a potential risk to the mental well-being of children. an abrupt change in the learning environment and limited social interactions and activities posed an unusual situation for children's developing brains. it is essential and obligatory for the scientific community and healthcare workers to assess and analyze the psychological impact caused by the coronavirus pandemic on children and adolescents, as several mental health disorders begin during childhood. countries across the globe, including the united states, are in the dilemma of determining appropriate strategies for children to minimize the psychological impact of coronavirus. the design of this review is to investigate and identify the risk factors to mental health and propose possible solutions to avoid the detrimental consequence of this crisis on the psychology of our future adult generations. since the first reported coronavirus case in wuhan, china, in , the outbreak, now known as covid- , has spread globally [ ] . the world health organization (who) acknowledged this coronavirus epidemic as a pandemic and declared the outbreak as a public health emergency of international concern [ - ]. most regions around the world are affected severely, including the united states, brazil, india, russia, and europe, which have seen an increasing number of cases and deaths than the rest of the world [ - ] . as of august th, , the coronavirus had spread to more than countries and has at least , , confirmed cases, resulting in , confirmed deaths globally. in the united states, between january th and august th, , there have been , , confirmed cases of covid- with , deaths [ ] . the spread of the virus has caused global economic and social disruptions and has brutally overwhelmed the healthcare and educational systems [ ] . the unexpected disruption of the social fabric and norms has affected the behavioral and mental health of the public, including children. the mental health of children has been influenced by several ways, as this unprecedented situation changed a way they typically grow, learn, play, behave, interact, and manage emotions. children with pre-existing psychiatric disorders such as attention-deficit/hyperactivity disorder (adhd), anxiety, depression, mood disorders, and behavior disorders could be adversely impacted during this stressful situation [ ] . mental disorders are the leading cause of disability worldwide in adolescents and children. about % of children and adolescents in the world have mental health disorders or conditions. nearly % of mental disorders start to affect the children by the age of . if left untreated, a child's mental development has been found to be drastically and detrimentally impacted. it is well established that mental health is one of the essential parts of human development and determines the outcome of a child's educational attainments and the potential to live fulfilling and productive lives [ ] . mental illness can affect children at any point during their childhood, but it most significantly affects them during adolescence. among the several mental illnesses that can be prevalent in childhood, depression is one of the major leading causes of mental illness amongst children. in , an estimated , deaths were due to adolescent suicide, which is the third leading cause of morbidity in this group. this emphasizes that adolescence is a period of vulnerability for the onset of mental health conditions [ ] . as of august th, , countries have closed schools and educational facilities worldwide due to the covid- pandemic, impacting , , , learners, consisting of about . % of students globally. it has forced several countries to implement home-based learning or online training [ ] [ ] [ ] . approximately . billion students and their families have been affected by school closures due to the pandemic. these students are experiencing further distress due to the unavailability of adequate help and attention from the trained instructors, making education more expensive for them and their families as they need to utilize additional time, support, and resources. due to the closing of schools, students' interaction and communication with school mates, play, exercises, and peer-activities are hindered, which have proven vital for the growth, development, and learning of the young human minds [ ] . the children who are at most significant risk are the youngest ones as their brains are still developing and are being exposed to high levels of stress and isolation, which can lead to permanent abnormal development. children exposed to stressors such as separation through isolation from their families and friends, seeing or being aware of critically ill members affected with coronavirus, or the passing of loved ones or even thinking of their own death from the virus can cause them to develop anxiety, panic attacks, depression, and other mental illnesses [ ] [ ] . the conducted literature search was through medline, pubmed, pubmed central, and embase using the keywords, 'coronavirus,' 'covid- ,' 'mental health,' 'child and adolescent,' 'behavioral impact,' 'psychological conditions,' 'quarantine,' and 'online education.' the indexed search aimed to identify literature and articles relevant to our focused topic. the objectives of this review article are . to understand the overall psychological impact of covid- on children and adolescents; . identifying factors contributing adversely to their mental health; and . proposing interventions based on the guidelines and evidence-based practices. the outbreak of covid- has disrupted the lives of many people across the world. the pandemic has imposed a sense of uncertainty and anxiety, as the world was unable to predict or prepare for this crisis. it has caused a tremendous stress level among children, adolescents, and all students in general, primarily due to the closure of their schools. this stress may lead to undesirable adverse effects on the learning and psychological health of students [ ] . children exposed to these incidents can precipitate the development of anxiety, panic attacks, depression, mood disorders, and other mental illnesses [ ] . distressing events such as separation from family and friends, seeing or being aware of critically ill members affected with coronavirus, or the passing of loved ones or even thinking of themselves perhaps dying from the virus would have a detrimental effect on the mental health. additionally, the healthy daily routines of children have been disrupted due to the covid- , which contributes to the additional stress and sleeping difficulties that many children face. uncertainty of their future ambitions, academics, personal relationships, and inactivity due to the pandemic poses a significant threat to their mental well-being and putting them at risk of drug abuse [ ] . covid- can seriously leave a negative impact on children's mental health, just like other traumatic experiences humans may face. it can lead to higher rates of depression, anxiety, and post-traumatic stress disorder. this causes fear in children because the virus threatens not just them but also their families and surroundings, especially as they see their parents working from home, leading to fear and shock [ ] . previous studies on severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers), and ebola have revealed that the disease causes severe emotional distress during the outbreaks. unfortunately, studies were not adequately conducted on the children and adolescents during the past outbreaks to measure its impact on their mental health, but several parallels can be drawn. the situation of covid- is comparable with the mers and sars, as similar claims made about the severity of mers caused fear, worry, and anxiety among the public. a study on the sars survivors with psychiatric disorders revealed that about % of the patients showed signs of post-traumatic stress disorder (ptsd), and . % of them had worsening depression [ ] . this finding corresponds to the increased suicide deaths among sars survivors, consisting of older adults from hong kong in and [ ] . among those mers survivors, lower quality of life was also noticed. neuropsychiatric linkage has been established based on the previous outbreaks [ ] . during this pandemic, children and their families have been exposed to direct or indirect factors that could pose stress and emotional disturbance. several weeks of homestay has forced parents and/or caregivers to work from home. also, many families lost their financial independence due to job losses [ ] . this disease is installing fear in children because children are worried about not only getting infected but also having their parents staying at home and not leaving for work [ ] . some families are struggling to feed their children, as many were dependent on school programs or food stamps, and not all families with resources can provide adequate supplies [ ] . however, the reach of the pandemic is unequal as numerous families have lost loved ones while others live in regions untouched by the virus. some children have parents who work on the front lines in covid- settings, and others have parents who now work from home or have recently been terminated [ ] . additionally, international students are impacted by uncontrollable factors such as school closure, campus closure, and travel restrictions. nations across the globe have restricted their borders to internationals to help mitigate the pandemic as many students might not have any other place to reside. this sudden closure of many nations to outsiders has placed a great burden on school administrators to ensure housing, sustenance, and safety of their international students [ ] [ ] . while transitioning to online classes has helped both international and national students to continue their education, several children and faculty members are experiencing distress because they may not have the technological capability or expertise required to navigate this new mode of interaction. the online teaching method has raised questions for the faculty about their capability to deal with the existing technology [ ]. the covid- pandemic has caused unprecedented health and humanitarian crisis. it has created an economic downturn due to the necessary measures to contain the spread of the virus. as per the latest global financial stability report, there is likely to be financial instability, which would lead to a devastating recession. the combined economic uncertainty and emotional distress placed on a family will challenge the overall well-being of families as well as their mental health [ ] . it is paramount to encourage and adopt healthy behavior to maintain the overall well-being of families. the well being of caregivers or parents can directly impact the mental health of the children. parents are advised to follow and practice the guideline provided by the world health organization (who). the who has urged people to follow social distancing guidelines and avoid close contact with anyone, especially from the person showcasing any respiratory symptoms [ ] . the health organization has also emphasized maintaining better hygiene by consistently washing hands and using appropriate protective gear such as facial masks [ ] . it has also advised to take breaks from watching, reading, or listening to news stories, including social media, because continually being bombarded by news of the pandemic can be distressing. exercising regularly, practicing yoga or meditation, eating healthy, taking adequate and proper sleeping properly, and avoiding alcohol or drugs is key to maintaining mental health. it is also crucial that parents provide enough support to their children and help them to process the information about the pandemic because these interventions could help minimize their anxiety or fear [ ] . schools, parents, and healthcare institutions can also implement psychological first aid (pfa) guidelines to assist children with their mental distress. pfa can provide psychosocial support to any survivors of epidemic or disaster [ ] . it is developed to mitigate acute distress and assess the need for more advanced psychiatric care. it is beneficial to implement it during the early stages of crisis to assist survivors in coping with grief and avoiding the long-term impact of stress on mental health. the 'rapid' model of the john hopkins pfa tool includes five steps, (i) r -rapport and reflective listening, implemented throughout the interaction; (ii) a -assessing and evaluating the psychological needs; (iii) p -prioritizing the needs based on severity; (iv) i -intervening to mitigate distressing factors; (v) d -disposition and distribution of intervention to stabilize the survivor [ ] [ ] . schools should emphasize the mental health of students by supporting and providing updated health organization guidelines through online lectures. also, a licensed counselor should help students manage the covid- related stress by providing coping mechanisms and strategies in both group and individual sessions. counseling services should be available to support the mental health and well being of students on time. universities can establish a task force to make a plan to reduce the spread of the virus and for the following centers for disease control and preventions (cdc) guidelines. the committee should include members from diverse professional backgrounds and experiences, such as public health department, physicians, psychiatrists, psychologists, social workers, administrators, health and human services, international services center, human resources, admission offices, enrolment, and billing department, athletic department, and teachers. to reduce the distress experienced by students and faculty related to information technology (it) issues, a technical team should be available continuously, and learning tutorial videos should be shared with the end-users. similarly, teachers and faculty should support students and their parents through clear communication and assigning clear expectations [ ] . a licensed counsel should take a comprehensive assessment of students deemed susceptible through risk factors such as psychological issues, including poor mental health before the crisis, bereavement, injury to self or family members, life-threatening circumstances, panic, separation from family, and low household income. minimizing the interruption of psychiatric care for patients with pre-existing conditions via telepsychiatry will be helpful to continue monitoring patients as the pandemic may worsen some patients' conditions and would adversely impact them if they were unable to contact their doctor. psychological assessment will help them to cope with their mental issues and stabilize their condition as they gain more education and discuss the impact of a pandemic. it will provide them support and reassurance to build resilience and encourage them to stay positive and motivated [ ] . mental health involves the regulation of our emotions, psychological, and social well-being. per the cdc, mental health affects how we think, feel, and act. it also helps determine how we react to stress, correlate with others, and our decision-making. mental health is significant throughout our lives, from early childhood to adolescence and through adulthood. mental illnesses occur when mental health is affected and leads to conditions that affect the way a person thinks, feels, or behaves, such as depression, anxiety, bipolar disorder, or schizophrenia. mental health can cause conditions that may be acute or chronic and alter the way we live our lives daily by our rationalizations. psychological and physical health are interdependent, both working together to form who we are. mental illness, especially depression, limits rational thinking, and increases the risk for other health problems such as diabetes. the presence of chronic conditions can increase the risk of mental illness. it is vital to strike a healthy balance between students' physical and psychological well-being [ ] . protecting and maintaining the mental health of the future adult generation is only possible with the robust schooling and healthcare system. it is necessary to have adequate resources to overcome this crisis. recruiting additional school personnel, clinicians, and mental health counselors are needed to address the strain on the system for supporting students during this pandemic [ ] [ ] . comprehensive school mental health systems (csmhss) is required to deliver adequate assistance for the students effectively [ ] . csmhss is a school-community association developed for all students to provide a variety of services for every type of students, such as mental health services, health promotion and prevention, early identification and interventions of diseases, and treatments for students evidence-based medicine [ ] . the csmhss should be enabled to collaborate with counselors, community mental health, and physical healthcare providers to help prevent mental health issues and make necessary referrals through an online interface for the treatment. the recruitment of additional school personnel and mental health counselors will help the students manage their anxiety, depression, and/or stress due to covid- ; and to stabilize any previously diagnosed mental illness or prevent new mental illness from developing [ , ] . moreover, children with inadequate information about why quarantine measures have been taken are found to have more anxiety. therefore, it is essential to expose children to more information about covid- through several sources, such as the evening news [ ] [ ] . this will make children more aware of the reason behind not only why quarantine measures were put in place, but they will also learn more about what covid- is. parents and guardians are encouraged to speak with their children about the information they learned, which may help lessen the negativity associated with covid- and quarantine. additionally, communicating with children about how they are processing the information will provide children with the emotional tools they require to do well in quarantine [ ] . not only can parents inform children about quarantine, but they can also employ "positive parenting" [ ] . children are prone to observe parents' and family members' moods during quarantine, which the children react to. through positive parenting, parents, guardians, and family members can create consistent daily routines to avoid the distress of unstructured days [ ] [ ] . while parents can provide a deeper understanding of the covid- and quarantine, school systems can provide further reassurances and educate children about emotions [ ] . school systems have the unique opportunity to provide consistent information to a large student body, who is unable to access other mental health programs in the areas [ ] . furthermore, school systems must adapt to the new online learning method and help students adjust and thrive in online classes [ ] [ ] . additionally, children can be taught coping mechanisms to self-regulate their own emotions without dependence on others. one method that achieves this goal is behavioral activation, which focuses on participating in activities they enjoy and not employing avoidance behaviors [ ] [ ] . alongside the other interventions mentioned above, behavioral activation can help children improve their problem-solving skills by engaging in healthy behaviors rather than unhealthy ones [ ] . due to the isolation indirectly imposed by the pandemic, children would be expected to prosper better in these times when they are taught ways to help themselves [ , ] . the epidemiology and clinical information about covid- covid- strategy update children's mental health child and adolescent mental health adolescent mental health empowering students with disabilities during the covid- crisis covid- is hurting children's mental health coping with stress as coronavirus prompts colleges to close, students grapple with uncertainty long-term psychiatric morbidities among sars survivors a revisit on older adults suicides and severe acute respiratory syndrome (sars) epidemic in hong kong coronavirus: universities are shifting classes online -but it's not as easy as it sounds covid- crisis poses threat to financial stability focus on mental health during the coronavirus (covid- ) pandemic: applying learnings from the past outbreaks sustainability of psychological first aid training for the disaster response workforce the johns hopkins model of psychological first aid (rapidpfa): curriculum development and content validation the role of psychological first aid to support public mental health in the covid- pandemic guidance to states and school systems on addressing mental health and substance use issues in schools how essential is to focus on physician's health and burnout in coronavirus (covid- ) pandemic? lifetime prevalence of mental disorders in u.s. adolescents: results from the national comorbidity survey replication-adolescent supplement (ncs-a) lifetime prevalence and age-of-onset distributions of mental disorders in the world health organization's world mental health survey initiative. world psychiatry psychological burden of quarantine in children and adolescents: a rapid systematic review and proposed solutions mental health effects of school closures during covid- psychological interventions during covid- : challenges for low and middle income countries mental health interventions in schools in low-income and middle-income countries school closure and management practices during coronavirus outbreaks including covid- : a rapid systematic review key: cord- -dx wvqkm authors: dahl, viktor; tegnell, anders; wallensten, anders title: communicable diseases prioritized according to their public health relevance, sweden, date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: dx wvqkm to establish strategic priorities for the public health agency of sweden we prioritized pathogens according to their public health relevance in sweden in order to guide resource allocation. we then compared the outcome to ongoing surveillance. we used a modified prioritization method developed at the robert koch institute in germany. in a delphi process experts scored pathogens according to ten variables. we ranked the pathogens according to the total score and divided them into four priority groups. we then compared the priority groups to self-reported time spent on surveillance by epidemiologists and ongoing programmes for surveillance through mandatory and/or voluntary notifications and for surveillance of typing results. pathogens were scored. the result of the prioritization process was similar to the outcome of the prioritization in germany. common pathogens such as calicivirus and influenza virus as well as blood-borne pathogens such as human immunodeficiency virus, hepatitis b and c virus, gastro-intestinal infections such as campylobacter and salmonella and vector-borne pathogens such as borrelia were all in the highest priority group. % of time spent by epidemiologists on surveillance was spent on pathogens in the highest priority group and all pathogens in the highest priority group, except for borrelia and varicella-zoster virus, were under surveillance through notifications. ten pathogens in the highest priority group (borrelia, calicivirus, campylobacter, echinococcus multilocularis, hepatitis c virus, hiv, respiratory syncytial virus, sars- and mers coronavirus, tick-borne encephalitis virus and varicella-zoster virus) did not have any surveillance of typing results. we will evaluate the possibilities of surveillance for the pathogens in the highest priority group where we currently do not have any ongoing surveillance and evaluate the need of surveillance for the pathogens from the low priority group where there is ongoing surveillance in order to focus our work on the pathogens with the highest relevance. national public health agencies need to prioritize their activities as there are limited resources for surveillance of on communicable diseases. established routines, personal interests and short-term political agendas can lead to a situation where resources are spent on surveillance of pathogens with less relevance for public health. the public health agency of sweden identified the need to use a structured method that takes relevant aspects into account in order to rationally prioritize between different pathogens when allocating resources for surveillance. in the literature we found several attempts to create frameworks and procedures for prioritization in public health [ ] [ ] [ ] [ ] [ ] . some attempts have also been made to prioritize among pathogens causing communicable diseases [ , ] . the method we identified to be most appropriate to our needs was one that was developed at the robert koch institute in germany in [ ] [ ] [ ] . the robert koch institute started by generating a list of pathogens to prioritize and included pathogens that were a) notifiable according to german law, b) reportable within the european union, c) reportable to the world health organization under the international health regulations, d) agents with potential for deliberate release, and e) pathogens represented in the "control of communicable disease manual" by heymann et al. [ ] occurring in germany. some pathogens were then grouped together when biologically and clinically plausible. the robert koch institute invited ten senior external experts and ten internal experts and asked them to score the pathogens with - , or for ten variables"incidence", "work and school absenteeism", "health care utilization", "chronicity of illness or sequelae", "case fatality rate", "proportion of events requiring public health actions", "trend", "public attention", "prevention and treatment possibilities") ( table ). the scoring was done in a modified delphi process consisting of two rounds. first, the panel of experts received the list of pathogens they should score. they then gave their score and motivation for the score given. the scores and motivations were anonymized and sent out in a second round so each participant could change their answers in light of the other experts' replies. this was done so that the panel could reach a consensus without letting "group dynamics" affect the process. internal and external experts were then asked to give a weight of to for each criterion and the median value was then used to give each criterion a weight. the score for each pathogen was multiplied by the weight and re-scaled from - . the pathogens were divided into four priority groups (the highest, high, medium and low) based on their final score. the cut-off limits for the groups were - , - , - , and - . we made some modifications to the prioritization method and then applied it in sweden in order to generate a prioritized list of pathogens. we then measured the current allocation of resources for surveillance at the public health agency of sweden in order to examine to what degree resources were spent after public health relevance. we used the methodology developed at the robert koch institute [ ] , with some modifications as described below. we started with the list of pathogens that had been used during the prioritization procedure in germany. we then distributed the list among experts at the public health agency of sweden (at the time "the swedish institute for communicable disease control"). experts at each unit at the institute were allowed to make additions to the list if they deemed it to be necessary. after additions we then removed pathogens where spread is not ongoing, or deemed not likely to occur, in sweden. this gave us the final list of pathogens to prioritize. we used the same scoring criteria as in the original method with some modifications. the criterion for incidence was changed to include not only symptomatic infections but also asymptomatic infections (but not asymptomatic colonization with bacteria). we also changed the table . prioritization variables. the ten variables that pathogens were scored for during the prioritization and the criteria for each score. scoring values need for medical treatment is established but currently no effective treatment is available or amr limits treatment options amr = anitimicrobial resistance note . all criteria apply to the geographical settings where the prioritization is conducted; the time-frame applicable to the requested epidmiological data should be defined prior to the process initiation and depends on the frequency with which pathogens are planned to be re-scored. indicated numercial thresholds apply to the country where the prioritization is conducted: in other geographical settings different thresholds might need to be considered. note . event is defined as the occurrence of a disease that is unusual with respect to a particular time, place or circumstances. for certain infectious diseases one case may be sufficient to constitute an event (e.g. polio virus). public health actions are any kind of targeted actions aiming to identify the nature of the event and/or to apply control measures in response to the event occurrence. *assessed against the total burden of infectious diseases. **assessed for each particular pathogen in question, e.g., the criterion "treatment possibilities and needs" refers to availability and adequacy of treatment for each case of an illness caused by a particular pathogen but does not take into account the incidence of illnesses or the availability of preventive measures. doi: . /journal.pone. .t criteria of "chronicity of illness and sequelae" from the contribution of a pathogen to the total amount of chronicity or sequelae to "the risk for each pathogen to cause chronicity and sequelae" (table ) . five experts were invited to participate in the scoring procedure. one expert from the national board of health and welfare, one from the public health agency of sweden and three experts who were county communicable disease control officers. we sent out the pathogens for scoring in batches of around ten pathogens in each batch. the weighting step was removed. this was the other modification of the german method in addition to those mentioned in the "scoring" paragraph. as in the original method, the scores for each variable for each pathogen were summarized and the score for the pathogen was then re-scaled to - in order to reach the final score. we then compared the outcome of the prioritization process in sweden to the outcome in germany by examining which (if any) pathogens were prioritized more than one group higher or lower in the swedish list compared to the german list. for those pathogens we examined how the scores for each variable differed. in order to examine how resources are currently allocated in relation to the outcome of the prioritization procedure, we selected three key indicators. first, we compiled a list of all pathogens that are currently under surveillance by the public health agency of sweden through mandatory and/or voluntary notifications of cases by clinicians and/or laboratories. we did not include systems for "event-based surveillance". even if only one manifestation of the pathogen (e.g. invasive infection or strains with antibiotic resistance) was under surveillance, that pathogen was considered to be under surveillance. in addition, according to swedish law, all cases of viral meningoencephalitis are notifiable. thus we considered the viruses that can cause viral meningoencephalitis to be under surveillance. second, we asked all epidemiologists responsible for surveillance of a particular pathogen at the national public health agency to estimate how many full-time equivalents (ftes) ( year of full time work = fte) that were spent on surveillance activities for each pathogen, as an average over a year (if several people worked with one pathogen their work time was combined). time spent on surveillance of typing results was not included in this estimation. third, we compiled a list of all pathogens that were under surveillance through typing (e.g. sequencing, pulsed-field gel electrophoresis and resistance patterns for antibiotics) of all isolates or a sample of isolates depending on the pathogen. either through collection of typing results from the laboratories at the county level or where isolates were collected and typed at the public health agency of sweden. this work was considered to be part of the duties of the public health agency of sweden and clearance was given by the public health agency of sweden before the study was started. the study did not involve human subjects. experts in infectious diseases were consulted as part of their job as communicable disease officers. using the process described in the method section "selection of pathogens" we generated a list of pathogens. this list of pathogens were distributed in batches to the experts for scoring. after scoring and re-scaling of the scores pathogens were in the highest priority group, in the high priority group, in the medium priority group and in the low priority group ( table and s table) . in sweden pathogens were prioritized compared to in germany. twelve pathogens were prioritized in sweden but not in germany and pathogens were prioritized in germany but not in sweden. three pathogens differed by more than one group when comparing the swedish to the german list ( table ) . borrelia was placed in the highest priority group in sweden but in the medium priority group in germany. staphylococcus epidermidis (coagulase-negative staphylococcus) was placed in the medium priority group in sweden but in the highest priority group in germany. hepatitis e virus was placed in the lowest priority group in sweden but in the high priority group in germany. borrelia differed in the scores for "chronicity of illness or sequelae", s. epidermidis differed in both "incidence" and "chronicity of illness or sequelae" and hepatitis e differed in "incidence" when comparing the swedish to the german scoring for each variable (data not shown). at the national public health agency of sweden we currently conduct surveillance based on mandatory notifications for of the pathogens and on voluntary notifications for pathogens, of the pathogens that were prioritized ( table ) . of the pathogens under surveillance through notification of cases ( %) were in the highest priority group, ( %) in the high priority group, ( %) in the medium priority group and ( %) in the low priority group ( table ) . two pathogens, (borrelia and varicellazoster virus) were in the highest priority group but did not have any ongoing surveillance through notification of cases. eight pathogens under surveillance through notifications of cases were placed in the low priority group (atypical mycobacteria, chlamydiophila psittacci, entamoeba histolytica, hepatitis e virus, jc-virus, salmonella typhi and paratyphi, vibrio cholerae and vibrio non-cholerae). work-time for epidemiologist for surveillance corresponded to . fte per year (this was however distributed among more epidemiologist than since some work part-time and for some not all of their work time is dedicated to surveillance related activities) (s table) . . fte:s ( %) of the ftes were spent on pathogens in the highest priority group. . fte:s ( %) were spent on pathogens in the high priority group and . fte:s ( %) were spent on pathogens in the medium priority group. of the pathogens under surveillance through typing ( %) where in the highest priority group, ( %) were in the high priority group, ( %) in the medium priority group and ( %) were in the low priority group ( table ). ten pathogens in the highest priority group did not have any surveillance through typing (borrelia, campylobacter, calicivirus, e. multilocularis, hepatitis c virus, human immunodeficiency virus, respiratory syncytial virus, sarsand mers coronavirus, tick borne encephalitis virus and varicella-zoster virus). in the low priority group there was only surveillance through typing for salmonella typhi and paratyphi. we used a standardized procedure developed at the robert koch institute to generate a list of pathogens prioritized for surveillance to be used by the public health agency of sweden. before applying the robert koch institute prioritization procedure in sweden we made two modifications in order to make the procedure less time consuming. first, we excluded pathogens where there was no ongoing spread in sweden or where spread in sweden was not deemed likely. second, we excluded the weighting step described in the original procedure. the reasons for excluding the weighting step was that in the experience from germany for some variables, such as "public attention" there was a high variation in the weight given by different experts. in addition for some variables the weight given differed between different groups of experts in germany. for example "incidence" was given a high weight by epidemiologists and public health experts but a low weight by clinicians. the relationship was reversed for the criteria "work and school absenteeism" and "health care utilization". the number of experts invited from each category therefore affected the weighting score. due to these limitations and in order to make the procedure less time consuming we decided to remove the weighting step. we also made modifications to the scoring criteria for two of the ten variables. we changed the criteria for "incidence" so that it would also include asymptomatic infections. we made this change since even asymptomatic infections can require interventions such as contact tracing and vaccination of those exposed. in addition, the swedish sureveillance system for notifiable diseases does not include data on whether the infection was symptomatic or not. thus, there is a lack of epidemiological data in sweden that differentiates between symptomatic and asymptomatic infections. we also modified the criteria for chronicity of illness and sequelae from the contribution of a pathogen to the total amount of chronicity or sequelae for all pathogens combined to the individual risk for each pathogen to cause chronicity and sequalae. this was done in order to give the incidence of a pathogen less influence as incidence was already included as a separate variable. only three of the pathogens (borrelia, s. epidermidis and hepatitis e virus) that were included in the prioritization procedure in both sweden and germany differed by more than one priority group. to some extent this difference could have been due to changes in the scoring criteria for the variables "incidence" and for "chronicity of illness or sequelae", but this was likely not the entire explanation to the differences in priority groups for these pathogens. true differences in incidence could explain why "work and school abseentism" and "health care utilization" was scored lower in sweden than in germany for s. epidermidis. the incidence for borrelia could also be higher in sweden which could have affected the scoring for "incidence" and "chronicity of illness or sequelae". public and media attention probably also differ between countries, which could explain why "public attention" for s. epidermidis and hepatitis e scored lower in sweden than in germany. lower scores for "prevention possibilities and needs" and "treatment possibilities and needs" for hepatitis e in sweden than in germany more likely reflect a difference in the interpretation of the available evidence on if and how this infection should be treated than a real difference in the available interventions for prevention or treatment between sweden and germany. we compared the ongoing surveillance at the public health agency of sweden to the prioritized list of pathogens which gave a useful indication on how well resources were currently allocated. when comparing the existing surveillance through notifications in sweden to the priority groups we found that the public health agency of sweden did not have any surveillance through notifications for two pathogens in the highest priority groups (borrelia and varicellazoster virus). we found that for eight pathogens in the low priority group (mycobacterium non-tuberculosis, chlamydophila psittaci, entamoeba histolytica, hepatitis e virus, jc-virus, salmonella typhi and paratyphi, vibrio cholerae and vibrio non-cholerae) there was ongoing surveillance through notifications. this could partly be explained by the law requiring all viral meningoencephalitis to be under surveillance, thus jc virus is under surveillance. for salmonella our method divided salmonella spp and salmonella typhi and non-typhi but the law requires surveillance for all forms of salmonella which could explain why salmonella typhi and non-typhi was under surveillance although it was considered to be of low relevance to public health. when we estimated ftes for surveillance through notifications per pathogen we found that % of ftes were spent on surveillance through notifications for pathogens in the highest and the high priority group. we take this as an indication that surveillance through notifications at the public health agency of sweden is already focused on the most important pathogens. we also compared the existing surveillance through typing results in sweden to the different priority groups. the surveillance through typing was to a large extent focused on the highest and the high priority group. however, ten pathogens in the highest priority group lacked programs for surveillance through typing (borrelia, campylobacter, calicivirus, e. multilocularis, hepatitis c, human immunodeficiency virus, respiratory syncytial virus, sars-and mers coronavirus, tick borne encephalitis virus and varicella-zoster virus). reasons for this could be that in the past, suitable methods for typing for some of the pathogens were lacking, but as new techniques such as whole-genome sequencing become less expensive, this might change. another reason for lack of surveillance through typing be due to the pathogenesis of the disease caused by the pathogen under surveillance. for example, when the symptoms for tick-borne encephalitis virus are seen, the virus is usually no longer detectable and isolation for typing is therefore not possible. discrepancies between ongoing surveillance through notifications and surveillance through typing and the outcome of the prioritization procedure should be interpreted with caution since there might be good reasons for not having surveillance for the pathogens in the highest priority group or for having surveillance for pathogens in the low priority group. the results should mainly function as an indication that the need for surveillance, or lack of surveillance, for certain pathogens should be evaluated. a key aspect to evaluate would be the availability of actions that could be triggered by the data from the surveillance system. this study had limitations. despite the modifications to the procedure, the delphi process was very time consuming and took over a year to carry out. apart from the associated costs, it could have led to "expert fatigue" and a changing interpretation of the ranking criteria over time. another limitation of this study is that we estimated full-time equivalents for surveillance through notifications per pathogen by self-assessment. this might not accurately reflect the actual time spent on surveillance through notifications for over a year. for example surveillance activities with a yearly variation (e.g. for influenza virus) might be overestimated if the assessment takes place during the influenza season and vice versa. in addition to that, ftes per pathogen also depend on the efficiency of the surveillance system. a poorly designed surveillance system might require more time spent than several well designed systems. we did not have the possibility to assess ftes for surveillance of typing results. furthermore, we did not measure the resources spent on research activities at the public health agency of sweden. it would be of interest to find out how they are distributed among the priority groups. in conclusion we have generated a list of pathogens prioritized for surveillance that can be used by the public health agency of sweden. the list could also be used when prioritizing among public health research projects on communicable diseases. we have made the prioritization method less time consuming when comparing the prioritized list to the current activities at the public health agency of sweden we found that to a large extent our activities are already focused on the pathogens with higher priority. we did however identify pathogens where surveillance (or discontinuation of surveillance) should be evaluated. the public health agency of sweden will consider surveillance for the pathogens in the highest priority group where we currently do not have any ongoing surveillance and to evaluate the possibilities to stop the surveillance for the pathogens from the low priority group where there is ongoing surveillance. in addition the results indicate that other countries with a similar panorama of communicable diseases and the same level of health care as in sweden and germany could consider using the list from either sweden or germany in order to save time. for countries who plan to conduct the prioritization method we recommend to consider additional modifications of the prioritization method in order to make it less time consuming, such as replacing the delphi procedure with a "mini-delphi" that can take place during a one-day workshop, which has previously been done in other settings [ ] . supporting information s table. scores for each pathogen and all variables. individual score, total score, re-scaled score and priority group for all pathogens prioritized. sweden, . (docx) s table. full-time equivalents spent on surveillance for each pathogen. self-estimated time spent on surveillance of notifications at the public health agency of sweden for all pathogens that were prioritized. sweden, . (docx) setting priorities for research. health policy on being a good listener: setting priorities for applied health services research. the milbank quarterly evaluating priority setting success in healthcare: a pilot study. bmc health services research priority setting: what constitutes success? a conceptual framework for successful priority setting. bmc health services research a checklist for health research priority setting: nine common themes of good practice establishing priorities for national communicable disease surveillance. the canadian journal of infectious diseases strategic emphases for tropical diseases research: a tdr perspective communicable diseases prioritized for surveillance and epidemiological research: results of a standardized prioritization procedure in germany prioritisation of infectious diseases in public health-call for comments. euro surveillance: bulletin europeen sur les maladies transmissibles = european communicable disease bulletin how can infectious diseases be prioritized in public health? a standardized prioritization scheme for discussion control of communicable disease manual a standardized process for developing a national notifiable diseases list in a pacific island setting. asia-pacific journal of public health / asia-pacific academic consortium for public health we want to express our gratitude to drs leif dotevall, anders lindberg, gunnar nylén and arne runehagen who participated in the scoring and to dr marion muehlen for valuable comments on the manuscript. we also want to than dr yanina balbanova from the robert koch institute, germany, for kindly providing us with data from the prioritization procedure carried out in germany. conceived and designed the experiments: vd at aw. performed the experiments: vd at aw. analyzed the data: vd aw. wrote the paper: vd at aw. key: cord- - x nmwwt authors: patel, love; elliott, amy; storlie, erik; kethireddy, rajesh; goodman, kim; dickey, william title: ethical and legal challenges during the covid‐ pandemic – are we thinking about rural hospitals? date: - - journal: j rural health doi: . /jrh. sha: doc_id: cord_uid: x nmwwt nan another ethical challenge is health care provider concerns regarding occupational hazard. health care providers, like any other humans, are not immune to flight or fight responses during stressful situations. health care providers' willingness to work against a potentially lethal infectious agent has also been investigated in several studies. , in these studies % of physicians reported willingness to work with patients with contagious and potentially lethal conditions, but only % agreed that "physicians have an obligation to work during an epidemic even if doing so endangers their health." rural communities, whose population makes up % of the us, frequently struggle with limited health care workforce and resources under ordinary conditions. when tertiary care hospitals reach capacity, rural hospitals and their communities may experience severely reduced access to critical care services and related resources as a result of timing and proximity, further exacerbating pre-existing real and perceived health care disparities. these disparities have not been well-studied, but they are a source of concern during preparation for widespread disasters such as pandemic infection. distribution of scarce medical resources including personnel, equipment, and services is a sensitive issue during a pandemic. complicating the picture, older adults with multiple preexisting medical comorbidities are more vulnerable for worst outcomes of this pandemic and make up a higher share of the population in rural areas, which are already ailing with poor medical resources. in addition to ethical dilemmas, another concern among health care providers and health systems are legal issues they may face during and after crisis situations. the history of medical malpractice dates back to the first half of the th century. legal and ethical education is very limited in medical schools and training programs across the us. law can help to establish a more flexible response by authorizing quick actions that otherwise would not have been permitted, for example waiving specific laws and providing liability protection for entities acting in good faith. conversely, law can be used to hold hospitals and health care workers accountable for patient injuries and harms, or for failing to plan for disasters. during the current situation, as in any other disaster, health providers are entering into unknown territory of ethical and legal complexity. ethical guidance and legal and medical frameworks are an increasingly common component of disaster response plans, particularly mass casualty events. because standards of care address not only what care is given, but to whom, when, by whom, under what circumstances, and in what places, planning must address all these factors to define appropriate standards of care in planning prior to mass casualty events. although the health and medicine division of the national academies of science, engineering and medicine offers important guidance about frameworks of overall crisis standards of care plans, different states embrace somewhat different basic ethical frameworks. legal and ethical challenges are inevitable in health care, and impossible to understand fully prior to, and during, an unprecedented event like the one we are currently facing. review committees were formed in the s for approval of abortion decisions. in the s, dialysis priorities were reviewed by ethics committees. while only % of hospitals had hecs in , this rate increased to over % by . limited data exist on effectiveness of ethical case intervention in adult patients. ethics committees are involved in different roles in different hospitals, but most are involved in patient care discussions following a request from the bedside care team facing an ethical dilemma. active and organized ethics committees are needed to facilitate thoughtful and equitable planning and execution of care throughout the medical care delivery system during the current crisis. the reorganization of ethics committees and development of institution-and system-level policies for allocation of health care resources requires input from multiple stakeholders. physicians and nurses, legal professionals, ethicists, risk management staff, the general public, and patient advocates can all provide invaluable perspective and guidance during this process. smaller hospitals, including community hospitals and rural institutions, frequently have less organized or non-existent ethics teams. when ethics teams do exist in these facilities they may meet infrequently, be consulted infrequently, and lack robust support from the health care and lay communities. further, local relationships in rural areas are often overlapping, which further complicates ethical decision-making as objective parties with appropriate knowledge and perspective are sometimes not available. our health system includes both large urban hospitals, medium-sized suburban hospitals, and rural and critical access hospitals. this allows us to work in concert to prepare for the challenges, and to bring the strengths of each health campus to bear on our current crisis. at our large urban hospital the clinical ethics and value program was organized recently, about a year ago. previous work of this team was limited to its home hospital, and included challenging decisions about goals of care; assisting with management of patients with substance use disorder; and clarifying how to manage challenges in frontline health care. currently, the program has expanded its reach to bring together professionals with wideranging perspectives throughout the health system to ensure that our process for ethical decision-making during the covid- pandemic includes the concerns of small and large facilities, and shares resources in a way that all the communities we serve can understand and support. hospitalists, intensivists, ed physicians, medical staff leaders, and nurses are working closely with ethics specialists, administration and legal counsel, and preparing as a team for the worst case scenario. the ama code of ethics advises, "because of their commitment to care for the sick and injured, individual physicians have an obligation to provide urgent medical care during disasters. this obligation holds even in the face of greater than usual risks to physicians' own safety, health, or life." the ability of health systems to support providers with practical tools such as clinical education, specialist consultation, and adequate ppe will be part of this story. ethical support, with fair allocation of scarce resources and support for frontline staff experiencing moral distress as a result of the crisis, will also contribute. in the end, if history is any guide, most clinicians will choose to stay following the heroic example established through history and today. , the point at which preparedness dissolves into panic will always be context dependent. but the tragedy in italy reinforces the wisdom of many public health experts: the best outcome of this pandemic would be being accused of having over prepared. covid- and italy: what next? coronavirus disease (covid- ) outbreak in iran; actions and problems augmentation of hospital critical care capacity after bioterrorist attacks or epidemics: recommendations of the working group on emergency mass critical care ready and willing? physicians' sense of preparedness for bioterrorism factors predicting nurses' consideration of leaving their job during the sars outbreak the impact of disasters on populations with health and health care disparities. disaster medicine and public health preparedness the ethics of responding to a novel pandemic america's first medical malpractice crisis medical malpractice litigation: a fellow's perspective legal preparedness: care of the critically ill and injured during pandemics and disasters: chest consensus statement assessing liability for health care entities that insufficiently prepare for catastrophic emergencies ethical guidance for disaster response, specifically around crisis standards of care: a systematic review allocation of ventilators in a public health disaster at law. ethics committees: from ethical comfort to ethical cover a national study of ethics committees ethical case interventions for adult patients preparing for covid- : early experience from an intensive care unit in singapore the presence of ethics programs in critical access hospitals facing covid- in italy -ethics, logistics, and therapeutics on the epidemic's front line must i respond if my health is at risk? physicians' legal duty of care and legal right to refuse to work during a pandemic key: cord- -hadtwybp authors: bell, sue anne title: practice informs research and research informs practice: the making of a disaster nurse scientist date: - - journal: j emerg nurs doi: . /j.jen. . . sha: doc_id: cord_uid: hadtwybp nan sue anne bell, phd, fnp-bc, nhdp-bc o ne of the greatest things about being a nurse is the multitude of paths and directions that a nursing career can take. nursing has led me from my first position in a -bed emergency department in south georgia to that of an assistant professor at the university of michigan, studying the health effects of disasters on vulnerable populations. the goal of this editorial is to describe my journey as a disaster nurse scientist, which i hope will inspire others to consider this area of scholarship. growing up in the florida panhandle, i lived through hurricanes and severe storms on a regular basis without too many personal consequences. recently, however, nearly every one of my relatives living there has experienced some kind of disaster-related loss. last year, i traveled with an emergency nurses association delegation to meet with emergency nurses in the town of port st. joe, florida, where i saw evidence of similar damage and loss. hurricane michael had devastated this small town in the fall of . the popular news cycle had already passed on this community's sufferings, but the devastation there still remained; not just damage to buildings and roads but also damage to the health and well-being of its residents. loss of jobs, damage to homes and businesses, changes in access to health care; all of these together critically affect the resilience of a community and the ability of its residents to lead healthy lives. port st. joe is recovering-and will be for years-while disasters across the united states are increasing in frequency and severity, affecting more and more communities, often with protracted recovery periods. , through my experience while studying disasters and health and providing care during the study, one of the most important things i have learned is that words do matter. one of them is 'natural disaster,' a term i avoid using. disasters in themselves are not natural. hazards such as hurricanes, wildfires and tornadoes are naturally occurring, but the impact that they have on societies is largely humanmade. these extreme weather events and fires are occurring more and with greater impact, as the effects of climate change advance. , characterizing disasters as natural implies that we cannot do anything about them, when we absolutely can make changes to become resilient to these events. , consider the difference between seasonal floods in uninhabited areas compared with the effects of flooding on communities, with the lower th ward in new orleans after hurricane katrina as an example. this is an area that has high levels of inequalities and was crippled by its already suspect infrastructure after hurricane katrina, which undoubtedly cost many lives. hurricane katrina devastated new orleans over years ago, but neither have we advanced very far in terms of a scientific understanding of the mechanisms behind disasters that affect health, nor have we taken the steps needed to mitigate their effects. as a new emergency nurse, i knew that i wanted a career where i could contribute in some small way to bring a meaningful change in the world, and that responding to crisis situations, like i experienced in the emergency department, would be part of that. i spent most of my early years in nursing in the emergency department and, later, in public health, both areas of practice that took time to learn and reach the point of practice mastery. then, i focused on issues of health equity in the emergencies that occurred in these settings, whether from a critical illness in the emergency department or loss of housing in the public health setting. these experiences eventually led me to the path of disaster nursing, as a volunteer with a local chapter of the american red cross. there, i supported families affected by small disasters, such as house fires or floods. in this role, i helped navigate immediate health and safety needs, such as obtaining new prescriptions for lost medications or securing short-term housing. one of the most formative parts of my nursing career, though, came when i joined a disaster medical assistance team (dmat) over a decade ago. this is an on-call position with the us department of health and human services national disaster medical system, to respond to disasters, public health emergencies and events of national security significance (such as state funerals) as a clinician. in this role, i have deployed to numerous areas of large-scale disasters and have often been away for weeks at a time with a short (or no) notice. i supported overwhelmed emergency departments after hurricane irma in , spent a month in puerto rico after hurricane maria working in urgent care, provided shelter care after the paradise, california, wildfires, and most recently, responded to separate deployments related to coronavirus (covid- ): one to the cruise ship quarantines and the other to conduct nursing home assessments and provide infection control training in maryland. each deployment brings different challenges and new opportunities to learn-in some i am asked to work to the full extent of my license and training. at other times, i provide very basic nursing care comparable with a novice's skillset. the bottom line for me is that i help meet crucial needs during national emergencies. dmat has also provided me the opportunity to receive the highest level of training available in disaster response; a year ago i spent a week at the university of nebraska's national training, simulation and quarantine center, preparing to respond to highly infectious disease situations, preparation that was then essential for the covid- pandemic, and gaining on-the-ground experience in providing care in disaster settings, experience that is crucial for a nurse scientist, not to mention the lifelong friends and colleagues i have made. a common challenge for academic nurses, such as myself, is walking the line between being a clinician and a scientist. many nursing faculty roles require leaving clinical practice. i am currently involved in efforts calling for new models of nursing education that value the ongoing clinical focus needed to inform research innovations in clinical care. i became a nurse scientist a few years into my nursing career, when i started asking questions about populations that were being affected disproportionately by disasters and about nursing practice in disasters and other emergencies, questions that i could not answer in my clinical setting alone. i knew there were answers to these questions, but i did not have the skills or sufficient knowledge to find these answers on my own at that time. there is much we know anecdotally about the effects of disasters, but much less has been substantiated through research. i also saw the need for leadership in disasters and health, and a space where i could use my clinical experience and educational preparation to advocate for those most likely to experience adverse health effects from disasters. i completed a phd in nursing from the university of michigan, focusing on health promotion and disease prevention, benefiting from formal training in advanced quantitative analysis, qualitative analysis, and health services research. i spent an additional years of postdoctoral training focusing specifically on health policy in the context of disasters. today, my program of research focuses on the longterm health effects of acute community-level disruptions, specifically weather and climate-related disasters, concentrating on aging and the associated vulnerabilities. older age itself does not make an individual vulnerable to disasters; however, social isolation, frailty, chronic and comorbid diseases, and cognitive impairment-all issues common among older adults-do. the shared scientific rationale that i build upon is that adverse health effects on older adults increase after a disaster due to potentially modifiable factors that occur not only at the individual level, but at the community level as well. identifying these factors can allow for progress toward the development of interventions to promote health, well-being and resilience in the face of these events. there is an unmet need for evidence-based interventions to prevent or minimize the impact of health breakdowns and improve health outcomes of older adults related to disasters. in addition to my nursing training, i draw upon multiple disciplines, including sociology, emergency management, geography, and epidemiology; as well as on nursing colleagues to conduct my research. a fundamental goal of my work has been to understand the effects of disasters on health through the analysis of large data sets. this has led to a greater understanding of health care and ed utilization, which impacts staffing for both emergency nursing and clinical practice. i examine the impact the large-scale disruption caused by a disaster has on individual and community functioning among older adults. for example, in an analysis using medicare claims data, we found that hospitalizations for any cause increased significantly among older adults in the -day period following a series of tornadoes in the southeastern united states. this study demonstrated that older adults remain affected by disasters longer than expected outside of the immediate recovery period. i have expanded the results of this study to include recent large-scale disasters, finding similar results. i have also provided evidence of the relationship between health risk behaviors and disasters, demonstrated through an analysis using longitudinal data from a larger study of retired adults. this research shows that this sample of older adults had an increase in weight gain and a more sedentary lifestyle after living through a disaster. and finally, in an analysis of cancer program data, our research team found that individuals with a cancer diagnosis who lived through a disaster were more likely to die sooner than those who did not. through my work, i have sought to understand the mechanisms behind older adults' responses to disasters throughout the disaster life cycle. by studying home-based care, my team identified challenges in provision of care in the postdisaster period for older adults, setting the stage for our ongoing qualitative study of home-based care after a disaster. using the national poll on healthy aging, a nationally representative survey of community-dwelling older adults, my colleagues and i found decreased preparedness actions among older adults, particularly among those who are socially isolated or medically vulnerable. , our systematic review explored the current state of science around health outcomes for older adults after disasters, which demonstrated the need for data-driven solutions on how best to provide care for older adults during and after disasters. these studies are relevant to emergency nursing as they drive decision-making on supporting older adults to remain healthy and resilient to disasters in their community, thereby avoiding ed visits. a crucial aspect of my research and clinical life is being an advocate for nursing and the populations i serve. serving in national leadership positions has been a route for me to contribute to defining and developing policy related to health and disasters. as a member of emergency nurses association's emergency preparedness committee, i had opportunities to co-author topic briefs related to crisis standards of care and active shooter emergencies, and also to contribute to a disaster response toolkit for emergency nurses. [ ] [ ] [ ] in response to the controversy surrounding disaster-related deaths due to hurricane maria in puerto rico, i joined the national academies of science, engineering and medicine committee on best practices to assess morbidity and mortality after large-scale disasters. this committee, sponsored by the federal emergency management agency, is defining the needs of the disaster research community to understand how to account for disaster-related deaths and illnesses, with a report to be released this fall. the covid- pandemic highlighted numerous gaps in the nursing workforce around preparedness. studies included in this special issue of the journal of emergency nursing have found a low-tomoderate level of disaster preparedness of emergency nurses around the globe, suggesting that a quality improvement project to increase nurse disaster preparedness through an education intervention may be an avenue to increase preparedness. leaders in the disaster nursing community and i called for needed changes in policy around pandemic preparedness for nurses in a recent report. finally, i am serving a -year term as health scientist representative on the federal emergency management agency's national advisory council, where i have the unique opportunity to contribute to recommendations to improve the federal response to disasters and other emergencies. in recent weeks, i have spent time as a clinician working with skilled nursing facilities affected by covid- , and i have also labored over my next research grant proposal that will allow me to continue my study of the larger effects of disasters on aging. as a nurse scientist, both are equally important, and both are rewarding. my goal is to build not only a better response to disasters, but also to contribute to building healthy and resilient communities that can withstand the effects of disasters for years to come. billion-dollar weather and climate disasters: overview. national centers for environmental information board on health sciences policy, institute of medicine. healthy, resilient, and sustainable communities after disasters: strategies, opportunities, and planning for recovery. national academy of sciences community resilience building community resilience to disasters: a way forward to enhance national health security maximizing the academic nursing model in the era of covid- and beyond all-cause hospital admissions among older adults after a natural disaster health risk behaviors after disaster exposure among older adults the effect of exposure to disaster on cancer survival home health service provision after hurricane harvey predictors of emergency preparedness among older adults in the united states supporting the health of older adults before, during and after disasters health outcomes after disaster for older adults with chronic disease: a systematic review emergency nurses association. disaster emergency essentials toolkit emergency nurses association. topic brief: crisis standards of care topic brief: active shooter preparedness in the emergency department increasing disaster preparedness in emergency nurses: a quality improvement initiative recommendations for improving national nurse preparedness for pandemic response: early lessons from covid- . security key: cord- -u u jho authors: hawton, annie; boddy, kate; kandiyali, rebecca; tatnell, lynn; gibson, andy; goodwin, elizabeth title: involving patients in health economics research: “the pacts principles” date: - - journal: patient doi: . /s - - - sha: doc_id: cord_uid: u u jho discussion of public and patient involvement (ppi) in health economics (he) research is growing. there is much literature on ppi principles and standards, but little specifically regarding involving patients in he research. here, we outline “pacts”, a set of principles, developed with a ppi group, for considering patient involvement in he research. planning: involvement is best built in to research plans from the outset. this includes setting specific goals for involvement activities, and clearly communicating the background and purpose of involvement. approach selection: we describe two main approaches to involvement—discussion-based and task-based. discussion-based approaches are useful for generating broad insights and revealing “unknown unknowns”. task-based approaches offer a more focused means of shedding light on “known unknowns”. continuous involvement: involving patients throughout the research process and across a range of projects helps build expertise for patients and insight for he researchers. team building: meaningful involvement creates a shared sense of ownership of the research and, over time, helps to develop a team ethos, enhancing the positive impacts of involvement. sensitivity: he research can be perceived as technical and impersonal. addressing this requires sensitivity, clarity, and an honest and open approach. there is increased recognition that patient contributors are experts at providing a “lived experience” perspective, in the way that clinicians are experts at providing an overview of conditions and hes are experts in the methodology of their discipline. we hope these “pacts principles” complement existing ppi approaches and provide a useful foundation for health economists considering patient involvement. electronic supplementary material: the online version of this article ( . /s - - - ) contains supplementary material, which is available to authorized users. public and patient involvement (ppi) in research is "research being carried out 'with' or 'by' members of the public rather than 'to', 'about' or 'for' them" [ ] . the role and presence of ppi in health research is developing internationally [ ] [ ] [ ] [ ] . ppi has particularly evolved over the last decades in the united kingdom (uk), to the point that it is now embedded in the policies of the national health service (nhs) [ ] and the culture of health services research [ ] . however, to date ppi has not been so explicitly prominent in the context of health economics (he) research. this is beginning to change, and focussed discussion of ppi in he research is growing [ ] [ ] [ ] . there is a broad body of literature on ppi practices, frameworks, and standards. for example, "uk standards for public involvement" was recently released to encourage "better public involvement for health and social care research". this sets out hallmarks of good public there are five main principles which may help health economists consider and approach patient involvement: planning, approach selection, continuous involvement, team building, and sensitivity. a "task-based" approach to patient involvement can help with the more technical aspects of health economics research. the development of ongoing patient-health economist partnerships can enrich patient involvement, ensuring it is non-tokenistic, meaningful, and helpful. ms and developed a task to facilitate the identification of implausible health states. this is described in detail elsewhere [ ] . following a debriefing session, during which the researchers and people with ms reflected on their experiences of the task, we agreed on a number of lessons for the researchers to take forward into future patient involvement. with these lessons in mind, our subsequent work with the hems group has been better planned and more inclusive. the group has expanded substantially, through recruitment of additional members from the south west region. invitations to join the ppi group were placed in local newspapers and ms centres. invitations were sent to existing ppi groups, such as the public involvement group at the national institute for health research's (nihr's) applied research collaboration south west peninsula (penarc) and local ms support groups. there are now members who work with us, as and when their ms permits. particular attention has been paid to addressing gaps in the membership of the group, particularly people aged under , who are in employment, and/or have relapsing-remitting ms [ ] . the role of group members is set out in a document based on the involve role description template [ ] , with amendments based on input from the hems ppi group and the researchers. the hems group has worked with us to develop successful funding applications, with plans for patient involvement integrated into all stages of our research protocols. we meet regularly to review progress and for the group to advise on specific aspects of the research. these have included identifying an appropriate research area and developing the associated research questions for a study; helping to design an interview schedule for cognitive interviews; advising on the content and wording of documentation for research participants; informing the development of resource use questionnaires for economic evaluations; developing attributes for a discrete choice experiment; identifying health-related events that may affect the wellbeing of people with ms; and assisting with the interpretation of results across a range of studies. their involvement has ensured our research reflects issues of importance to people with ms, improved the suitability of research materials for intended participants (potentially enhancing response rates and data quality), and given people with ms a voice in the interpretation of data. these lessons have been developed by the four people who have been involved throughout the lifetime of the hems group: the longest serving hems member (lt), two health economists (ah and eg), and a ppi practitioner (kb), and have been informed by formal and informal feedback from the wider hems group membership. this includes a recent involvement such as flexibility, sharing and learning, and respect for each other [ ] . such approaches are key for guiding supportive, non-tokenistic, meaningful, and useful ppi, but there has been little consideration of the particularities of he research and "what works" in terms of ppi in this specific discipline [ ] . over the last years, we have worked with people with multiple sclerosis (ms) to inform the development of a variety of he research studies. in this paper, we draw on our experiences, the experiences of those with whom we have collaborated, and our shared perspectives about what could have worked better and what has worked well. we outline the lessons we have learned about involving patients in he research, and offer some guidance to health economists and patients wishing to undertake research together. we do not seek to add another ppi framework to a crowded "marketplace", rather we aim to provide a way of thinking for he researchers who are getting started with ppi, introducing some principles to consider. we hope these reflections will be relevant to a wide range of conditions and aspects of he research, and complement more prescriptive frameworks. the health economics and ms (hems) patient involvement group was initially established to inform a specific aspect of a study that aimed to develop a preference-based measure of health-related quality of life for use with people with ms [ ] . this involved selecting a subset of the health states described by the measure for inclusion in a preference elicitation survey. we wanted to avoid selecting health states that seemed implausible to respondents, and considered that people with ms were best placed to identify which health states were implausible. we worked with three people with online video meeting with eight members of the group specifically to discuss these principles. where possible, we have drawn on available literature to compare our experiences with those of other research groups. it is considered best practice to build involvement into the overall research plan at the application stage; indeed, many funders require this [ ] . we have found that making involvement activities an integral part of the research from the outset has enabled us to identify which areas of a study require focused involvement activities and to formulate plans for monitoring and oversight of the research programme. when developing research ideas, we have found it useful to ask ourselves, "what information do we need for this research study that we can only (or best) get from patients?" a clear aim regarding the intended outputs from any involvement activity, and how these will be used to guide the research, is essential [ ] . previous research has found that involving people early in the research process, and setting clear goals and plans for involvement, engenders a sense of "ownership" of the research and enhances the impact of involvement [ ] . it also provides a basis from which to determine which involvement methods might be appropriate to meet the aims of each aspect of the planned involvement [ , ] . a crucial aspect when planning involvement activities is to ensure that the background and purpose can be communicated coherently to those involved in the research [ ] . one barrier to involving patients in he research that has been identified is that many of its main concepts and research methods are highly technical and can be inaccessible to lay audiences [ ] . we have found the key is to go back to the basics of what we are trying to achieve and to clearly define any core concepts, e.g. "plausibility". a particularly useful piece of advice from our ppi practitioner is that patient involvement materials do not need to be technically correct in the way that would be expected by an academic audience. rather, they should convey sufficient information to enable patients to understand the purpose of the research and to engage with it meaningfully. for example, using the description "an experiment where you are asked to make choices" might be a useful route in to discussing discrete choice experiments. in our experience, and as others have found [ ] , designing and planning involvement activities requires investment of time and resources, to ensure they generate intended outputs and make sense to the patients involved. we anticipate that designing involvement activities will become easier as more papers of this type are published, building a literature base that provides sources of different approaches for involvement in he research. plans for involvement also need to be responsive to changing circumstances. an obvious example is the impact of the coronavirus disease (covid- ) pandemic. there may be major changes in terms of treatments, etc., that arise unexpectedly and change the landscape for patients. risks and mitigations in relation to ppi can be considered alongside other aspects of he research, in order to maximise its flexibility to altered conditions. patients should be involved in a meaningful, non-tokenistic way that will provide the required inputs and insights [ , ] . in our view, there are two broad approaches to involvement: task-based and discussion-based approaches. each offers their own advantages and disadvantages, and will be more or less appropriate depending on the purpose and nature of any given research activity. this corresponds to dudley et al's. [ ] distinction between "focused" and "diffuse" impacts of ppi in relation to clinical trials, where the former represent specific effects on particular aspects of a study and the latter represent more general, less tangible benefits arising from researchers and ppi contributors working together. in our research, discussion-based approaches have worked well for generating "diffuse" impacts and revealing "unknown unknowns". these have included developing research questions, contributing to funding applications, overseeing research programmes, assisting with planning, and advising on communication with lay audiences. discussion-based approaches facilitate the identification of broad themes of importance to patients, and can provide crucial information that would otherwise be inaccessible to researchers who lack lived experience of a condition. where the research activity is more directed towards shedding light on "known unknowns", we have found that a task-based approach provides a useful framework for guiding detailed work on highly specific aspects of a study to generate "focused" impacts. the identification of health-related events that affect the wellbeing of people with ms and of attributes for a discrete choice experiment are two examples of "known unknowns" that were addressed successfully via a task-based activity. more detail on these is provided in the "appendix" (see the electronic supplementary material). the hems group have often commented on their enjoyment of using task-based approaches, which they have described as "hard work", but "thought-provoking" and "fascinating". the direct relationship between the tasks and the intended impacts on the research has ensured that exercises "did not feel tokenistic" and gave them "a sense of achievement". task-based approaches mandate a narrow focus, which is beneficial for developing aspects of a study where broader opinions, insights, and experiences would not impact the research design. this is advantageous in he, where many research techniques are highly prescriptive, with fixed parameters that are not open to influence from patient involvement (e.g. preference elicitation techniques, discrete choice experiment designs) [ , ] . in such cases, the use of a discussion-based approach could be considered disingenuous, as the broader inputs this generates could not be used to influence the research design without compromising the integrity of the research from an economic perspective [ ] , and ineffective, as it may not produce the precise information required. nonetheless, the focused nature of a task-based approach can result in issues of importance to patients being missed, and provides little opportunity to challenge orthodox he research practice from a patient perspective. thus it is important to acknowledge that this is not an "either-or" dichotomy, and that the two approaches can be used in concert. we have found that dividing up a session into discussion-based and task-based segments provides a useful balance of specific, focused information and broader insights. the most important lesson that the researchers took from their initial foray into patient involvement [ ] was the need to involve patients in developing patient involvement. in subsequent feedback, the hems group pointed out that various problems encountered during this session could have been avoided if we had worked with them to design the task. this highlights the importance of involving patients meaningfully at all stages of the research process [ ] . in our subsequent research, the continuous involvement of the hems group has both improved our research by integrating a patient perspective throughout the duration of each study and provided the hems group with a context for any specific involvement activities. this, coupled with the involvement of hems group members in the design of involvement activities, has resulted in clearer, more accessible activities that run smoothly, produce the intended (and some useful unintended) outputs and are more enjoyable for everyone involved. we have also found it invaluable to include funding for an experienced ppi practitioner as part of the research team, to provide specialist support for this work throughout the project. the continuity of involvement by the hems group has extended over a number of research programmes, enabling both group members and researchers to engage in a continuous process of gaining expertise and insight, which they then apply to future work [ , ] . we acknowledge that this scale and duration of involvement places a demand on people who have other things to do with their time, and are also dealing with a long-term condition. this can make involvement difficult to sustain over time [ ] . as recommended [ ] , we make it clear that hems group members can dip in and out over time, depending on their health or other circumstances, without need for explanation. we make use of various modes of involvement, including group meetings, one-to-one conversations, email, and social media, enabling meaningful involvement without the requirement to attend or speak at meetings [ ] . rather than meeting at fixed time intervals, we schedule hems group meetings to coincide with the points in the research programme when their specialist input is required, in order to make best use of their time [ ] . it is imperative that patients have the opportunity to receive summaries of research findings and their impacts. these should be conveyed regardless of the length of time since the research was conducted. better still is the involvement of patients in interpreting he research findings, considering their implications, and disseminating results. when reflecting on our first patient involvement task, the hems group felt it would have been beneficial to hold an introductory meeting prior to undertaking the task to build a working relationship and to discuss the broader context of the research. as other researchers have found, taking the time to establish strong working relationships, typified by shared understanding and trust, can generate greater positive impacts from involvement [ , , ] . successful patient involvement groups tend to feel increasingly safe within their own space over time, enriching and strengthening patients' input [ ] . we have found that the continuous involvement of the hems group across a number of projects over the years has enabled us to get to know one another and has engendered a shared sense of ownership of the research programme. in this way, we have become a team, each of us with our own expertise and knowledge to bring to the research. maintaining, extending, and strengthening these relationships over time has required us all to be flexible in our approach as we are challenged by each other's perspectives [ ] . crucially, we have aimed to make our involvement sessions enjoyable, to be clear about what impact the hems group's input will have on the research, and to ensure that they know how much we value this input [ ] . this has enabled us to increase the number of people with ms involved, and the extent and variety of their involvement. a realist evaluation study of ppi in health research [ ] found that providing informal opportunities for researchers and ppi contributors to socialise together can help foster good working relationships, and our experience supports this. scheduling social time before and after each formal hems meeting allows everyone to physically and mentally arrive, have an initial catch-up, and introduce any agenda items they wish to raise at the meeting, and provides a shared opportunity to reflect and to consider other issues that the session may have brought up. the group frequently use this as an opportunity to share information, e.g. which is the best company locally for building an outside ramp, and how to access physiotherapy services. it also provides the health economists with a greater awareness of what is important to people with ms, and of how their work could be made more inclusive, accessible, and relevant to patients. pandya-wood et al. [ ] have suggested that involvement can be emotionally challenging for patients if it causes them to reflect on negative aspects of their condition. other research studies have identified barriers to involvement in he research such as the perception of he as a highly technical discipline, far removed from real patient experience [ , ] , and controversies around the role of the national institute for health and care excellence (nice) in approving new drugs and treatments for use by the nhs [ ] . these factors caused us concern regarding our initial involvement activity with the hems group, in which we described some quite severe health states that the group members might imagine they would experience in the future. these concerns proved unfounded. the hems group have addressed these issues and other aspects of this complex discipline. there is a need to be considerate and sensitive when working with patients [ ] , but, as our hems coauthor remarked, "we come as a hardy bunch with armour already inbuilt!" the development of working relationships over time, described above, and the adoption of an honest and open approach are particularly important here. our aim in this paper has been to share the pacts principles: planning, approach selection, continuous involvement, team building, and sensitivity. we have aimed to provide practical guidance and illustrative examples for health economists and patients who wish to work together. there is increased recognition that patients are experts at providing a "lived experience" perspective in he research, in the same way that clinicians are experts at providing an overview of conditions and hes are experts in the methodology of their discipline. we hope the pacts principles complement existing ppi approaches and frameworks and provide useful foundations for health economists when considering patient involvement, and will ultimately build towards the development of practical guidance for patient involvement in he research. australia: consumers health forum of australia canadian institutes of health research. cihr's framework for citizen engagement. partnerships and citizen engagement branch. ottawa, canada: canadian institutes of health research new zealand health research strategy: public discussion document public involvement at national institute of mental health department of health. nhs constitution. london: hmso the missing stakeholder group: why patients should be involved in health economic modelling involving members of the public in health economics research: insights from selecting health states for valuation to estimate quality-adjusted life-year (qaly) weights. appl health econ health policy working with patients and members of the public: informing health economics in child health research uk standards for public involvement: better public involvement for better health and social care research knowledge of public patient involvement among health economists in ireland: a baseline audit estimating a preference-based index for an eight dimensional health state classification system derived from the multiple sclerosis impact scale (msis- ) a framework for public involvement at the design stage of nhs health and social care research: time to develop ethically conscious standards briefing note five: be clear with the people you want to involve. template two: role description. national institute for health research what difference does patient and public involvement make and what are its pathways to impact? qualitative study of patients and researchers from a cohort of randomised clinical trials patient and public involvement: how much do we spend and what are the benefits? continuous patient engagement in comparative effectiveness research research with patient and public involvement: a real-ist evaluation -the rapport study evaluating patient and public involvement in health research: from theoretical model to practical workshop is it worth it? patient and public views on the impact of their involvement in health research and its assessment: a uk-based qualitative interview study author contributions all listed authors ( ) made substantial contributions to the conception or design of the work or the acquisition, analysis, or interpretation of data; ( ) drafted the work or revised it critically for important intellectual content; ( ) approved the version to be published; and ( ) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. funding this work was funded by the ms society and supported by the national institute for health research (nihr) collaboration for leadership in applied health research and care south west peninsula. the views expressed are those of the authors and not necessarily those of the nhs, the nihr, or the department of health. code availability not applicable. key: cord- - fuiind authors: lee, albert; chuh, antonio at title: facing the threat of influenza pandemic - roles of and implications to general practitioners date: - - journal: bmc public health doi: . / - - - sha: doc_id: cord_uid: fuiind the pandemic of h n influenza, compounded with seasonal influenza, posed a global challenge. despite the announcement of post-pandemic period on august by thewho, h n ( ) virus would continue to circulate as a seasonal virus for some years and national health authorities should remain vigilant due to unpredictable behaviour of the virus. majority of the world population is living in countries with inadequate resources to purchase vaccines and stockpile antiviral drugs. basic hygienic measures such as wearing face masks and the hygienic practice of hand washing could reduce the spread of the respiratory viruses. however, the imminent issue is translating these measures into day-to-day practice. the experience from severe acute respiratory syndrome (sars) in hong kong has shown that general practitioners (gps) were willing to discharge their duties despite risks of getting infected themselves. sars event has highlighted the inadequate interface between primary and secondary care and valuable health care resources were thus inappropriately matched to community needs. there are various ways for gps to contribute in combating the influenza pandemic. they are prompt in detecting and monitoring epidemics and mini-epidemics of viral illnesses in the community. they can empower and raise the health literacy of the community such as advocating personal hygiene and other precautious measures. gps could also assist in the development of protocols for primary care management of patients with flu-like illnesses and conduct clinical audits on the standards of preventive and treatment measures. gps with adequate liaison with public health agencies would facilitate early diagnosis of patients with influenza. in this article, we summarise the primary care actions for phases - of the pandemic. we shall discuss the novel roles of gps as alternative source of health care for patients who would otherwise be cared for in the secondary care level. the health care system would thus remain sustainable during the public health crisis. the outbreak of novel influenza a (h n ) has caused a global challenge since the first case was identified on april . within nine weeks, all six who regions of the world were affected [ ] . the impact of this pandemic is compounded by the ageing population in many countries and the new epidemics of "non-communicable diseases" [ ] . more than , laboratory-confirmed cases from countries were identified by october [ ] . although who announced the post-pandemic period on august , h n ( ) virus would continue to circulate as a seasonal virus for some years and national health authorities should remain vigilant during the immediate post pandemic period due to unpredictable behaviour of the virus (who pandemic h n briefing note ) . a semi-quantitative study in australia reported that additional daily presentations to general practice surgeries would be - presentations per day [ ] . one of us (al) serving in public primary care setting had to re-organise some designated clinics in the catchment area to manage patients with influenza-like illnesses. however, such venture induced an increase in workload demand of other clinics for chronic illnesses, subsequently leading to double burden of diseases. another author (ac) working in a private primary care setting in the community experienced around % increase in workload demand for influenza-like presentations. if a new outbreak occurs, increase in patient load will be inevitable. should the presentations, risks of complications, and the infectivity of the new influenza pandemic be different, the situation could be much worse. how should we build up the spare capacity to prepare for and respond to the pandemic if it arises again? our capability of responding to the pandemic most countries have contingency planning. the royal college of general practitioners in the uk, for example, has issued clear guidelines for the management and control of pandemic influenza [ ] . however, the less developed countries are experiencing difficulties in putting these guidelines in operation owing to inadequate stockpiles of antiviral drugs to go beyond rapid containment in supporting the mitigation efforts [ ] . for the south-east asian countries, the hospital bed capacity and medical personnel might not have the capacity to care for sudden surges of large number of patients [ ] . during the early phase of the pandemic in may , concerns of the delay in launching of the uk national flu line were raised in an article published in the british medical journal. the line acted as the main route for the public to get advice and access to antiviral treatment [ ] . widespread community transmission of an infectious disease could overwhelm our health care system globally. close collaboration with functional components of public health such as home-based care and primary health care is therefore indispensable [ ] . absenteeism amongst health care workers could pose another threat to the health care system with the prolonged periods of a pandemic. a us-based survey found that nearly half of the health care workers might fail to report for duties during an influenza pandemic, particularly the technical and supporting staff [ ] . another study reported that % of german health care workers might remain absent from work in order to protect themselves [ ] . results from uk study on randomly selected healthcare workers suggest that absenteeism could be as high as % at any point during a pandemic [ ] . it has been estimated that a general practitioner (gp) might expect to see new cases per week for an average list size, which would rise to at the height of the pandemic if % of other gps were sick [ ] . however, these studies were done prior to the h n pandemic, and the data analyses were based on an h n situation which might not be valid to be extrapolated for the h n pandemic [ , ] . an uk study on how gps responded to an influenza pandemic revealed that at least one-quarter of the respondents would respond poorly to such a pandemic [ ] . non-urban gps were less prepared to an influenza pandemic as compared to urban gps and also less likely to be aware of pandemic preparedness plans. an article authored by jennings et al outlined the multistrategic approach to pandemic preparedness which would be categorised as non-pharmaceutical (public health) and pharmaceutical measures [ ] . the former is aimed to reduce the social impacts such as social distancing by prompt case isolation, household quarantine, and closure of school and workplaces. responce of health services with increasing number of possible flu cases and the existing care of other patients, risk communication, data collection and surveillance, and basic respiratory hygiene practices are all important public health measures. the pharmaceutical measures included vaccination, anti-viral medications, stockpiling of vaccines and drugs and co-ordinated effort in distribution. this would involve pre-pandemic vaccination and treatment of cases for secondary prevention. although vaccination for h n is now available, it does not entail overall willingness to accept. a study in hong kong amongst , health care workers showed that the overall willingness to accept pre-pandemic h n vaccine was only . % during a who influenza pandemic alert phase [ ] . no significant change in the level of willingness to accept vaccine was observed despite an escalation to alert phase [ ] . public health measures would be more effective with close collaboration between public health authorities and gps. gps in uk were generally praised on their dedication and efforts during the pandemic [ ] . most of the influenza cases were diagnosed clinically by gps, not virologically in the laboratories [ ] . the royal college of general practitioners closely liaised with health authorities and external agencies in the battle against h n influenza [ ] . daily updates were sent to their college members, and formal guidelines were in place specifically for gps in england [ ] and scotland [ ] . moreover, gps had access to a dedicated email address flu@rcgp.org.uk for enquiries and support. preventive interventions are more effective in primary care setting which are not related to any one disease or organ system [ ] . effective primary care integrates vertical care concerning the management of specific diseases from primary to tertiary care as well as horizontal care with emphasis on addressing the needs of individuals, families and the community [ ] . this is particularly important for preparing and responding to a pandemic of influenza. although routine long term implementation of some physical measures to interrupt or reduce the spread of respiratory viruses could be difficult, a systematic review showed that simple and inexpensive interventions could be effective in reducing the spread of respiratory viruses [ ] . good infection control (comprising policies and procedures to prevent or minimise the risk of transmission) is a well known cornerstone of disease management and should be the focus of general practice management of respiratory outbreaks [ ] . gps should be in excellent position to self-demonstrate as well as educating patients on the pertinence and efficacies of hygienic measures. the imminent issue now is how to translate these basic personal hygienic measures into day-to-day practice. gps possess unique skills to empower patients, and patients felt that they are better helped and more understood by gps [ ] . gps are in excellent positions to translate national guidelines into public health educationand put the daily lives of patients into context. they could also help to improve the health literacy of the community on infection control. gps in hong kong played this role during sars. the hong kong medical association established doctors' network amongst gps in different districts to support the local communities [ ] . if gps could play the role of health educators on preventive controls and the reinforcement of personal hygiene and other precautious measures in the community and serve as reliable resource persons to share and disseminate information to the community, the well subjects would thus be reassured. their important role of gps providing psycho-social support to the community during health crises is unique. gps are prompt in detecting and reporting epidemics and mini-epidemics of viral illnesses [ , ] . the epidemiological data obtained in primary care represents the best proxy measurements of the day-by-day prevalence of ailments in the community. gps can also assist in the development of protocols for primary care management of patients with flu-like illnesses in accordance to national guidelines to avoid missing cases while at the same time preventing panics in the community. a study conducted in hong kong revealed that gps were amongst the first group of doctors performing clinical audits in their practice in order to improve the structures, processes, and outcomes of their services [ ] . gps could play the frontier role in management of patients with influenza without complications to allow unexpectedly large numbers of ill patients to be managed in the community. gps could support the continuity of health care provision by acting as alternate source of health care for those patients who would otherwise attend specialist outpatient clinics, accident and emergency departments [ ] , or be hospitalised. moreover, gps are trained as generalists, so they can manage a diverse range of health problems. in some countries fully trained gps are capable of providing counselling to patients, their families, and alerted members in the community. pharmaceutical measures for pandemic preparedness include the provision of vaccines particularly during the pre-pandemic period, and anti-viral drugs for treatment of cases as well as secondary prevention for selective cases. although it was expected that the australian health management plan for pandemic influenza (ahmppi) would enable frontline australian gps to maintain a central role during the swine flu pandemic, their task was rendered extremely difficult owing to deficiencies in the implementation of ahmppi [ ] . this included resource supply failures, time-consuming administrative burdens, delays in receiving laboratory test results and approval for providing oseltamivir to patients, and a lack of clear communication about policy changes as the situation progressed [ ] . better consultation with front-line clinicians, particularly gps, is crucial; and this must occur as a matter of high priority. different countries have initiatives for gps to play their roles during the flu pandemic [ , ] . of specific interest is the "flu champion" in some australian practices, which actively advocates educational activities, promotes vaccinations, and ascertains the availability of antiviral medications [ ] . gps in the uk can access influenza vaccines subject to their clinical discretion during serious periods of the pandemic [ ] . no effort was spared to assure that gps would continue their services during the pandemic [ ] . the outbreak of sars in hong kong exposed the lack of support and guidance for gps and other primary healthcare professionals during a public health crisis [ , ] . despite fear, anxiety and uncertainty, gps in hong kong demonstrated their willingness and commitments to discharge their duties as healers [ ] . a study showed that . % of gps aspired deeper involvements in the war against sars in the community -as educators ( . %), as gatekeepers ( . %), utilising rapid diagnostic tests ( . %), and administering vaccines when available ( . %) [ ] . some gps expressed their wish to "share the government's outpatient burden and/or outreach services at elderly homes", and one doctor had volunteered to serve in a sars screening clinic [ ] . in terms of public health measures taken by gps, more measures were taken by gps in hong kong when compared to those in toronto [ ] . as the outbreaks were larger in scale and occurred at the community level in hong kong, the sense of vulnerability for possible infection in gps should be higher in hong kong. however gps in private practice voluntarily incurred negative commercial initiatives such as sharing patient loads, supplying appropriate protective barriers including expensive masks, delivering lectures in school and community centres, and being medical advisors for deprived members of the society such as inmates in elderly homes. those initiatives would become public health actions with public health authorities drawing up the action plans for the gps. the sars experience also revealed that patients were also unnecessarily referred to secondary care because of ineffective communications and the unavailability of some investigations to gps. valuable health care resources were thus inappropriately matched to community needs [ ] . this would put even heavier burdens on the health care system during the outbreak of influenza. if the public health authorities would work more closely with gps with more rapid communications in clinical information, epidemiological update and results of investigations, gps being the first point of contact for most patients in the health care system would provide better, comprehensive and continuing care during the public health crisis. studies in singapore, australia and uk all showed the willingness of gps to provide professional services during pandemic [ , ] . the findings were in sharp contrast to the sarcastic remarks by dawes in an editorial "caring for patient is a moral imperative during a pandemic influenza outbreak. i wouldn't be much of a human being if i closed up and headed for the hill." [ ] . however the motivation was also altruistic as gps participating in the australian study did not have stockpiles of antiviral or personal protective equipments within their own practices [ ] . they also believed that most appropriate setting to manage these patients was within gp practices and the government had a duty of care to stockpile on behalf of the gps. public health authorities would make good use of the public health initiatives currently in place in order to strengthen the roles of gps within the system. reassurance of well subjects, the assessment and management of patients unwell with influenza, the continuous care of unaffected patients, and the attendance to the psychological consequences of the disaster were defined by an australian study as key roles of gps during pandemic [ ] . gps should provide optimal management for patients without flu-like illnesses, empower self care of patients, and act as alternate sources of health care for stable patients from secondary care. the ultimate goal is to enable gps to relieve the workload of overwhelmed secondary care setting during the flu pandemic. the framework for general practice by nori and william described how to establish an effective level of infection control for different stages of outbreak [ ] . table summarises the primary care actions for different components at the different pandemic phases ( ) ( ) ( ) as defined by who [ ] . the framework of table goes beyond infection control at clinic level. it also covers measures to handle the suspected cases and close contacts, advice to patients returning from high risk areas, and the identification of high risk cases. this framework also enables the primary care system to play a leading role to sustain the health care services during the pandemic so that the health care system can cope with a large influx of patients with influenza like illnesses without jeopardising the care of chronic illnesses patients. primary health care should be more proactive as an alternate sources of health care for hospital patients with stable conditions, developing of protocol for self management for certain illnesses, acting as resource persons for patient health education in the community and providing leadership to re-organise the local resources meeting the local health care needs. it is highly crucial that such primary care action plan should be made readily available to gps not only during but also before a pandemic. all levels of primary care professionals from administrators to individual gp surgery professionals and allied health professionals should be alerted to the existence and elements of these action plans. when resources including time and manpower are available, mini-drills could be conducted in surgeries to investigate the practicalities and logistical barriers of these actions. we also recommend conducting clinical audits to assess the structure, processes and outcomes of these primary care actions. what should be the next step? the success of primary care in handling emerging health crises prompts us to re-conceptualise primary care as the foundation of care for all people rather than the mere provision of basic services for the lower strata of the society [ ] . this is particularly important for developing countries where the delivery of primary care is usually more fragmented, rendering the entire health care system more vulnerable to the emergence of an influenza pandemic. the roles of gps should also be broadened to take up greater share of patient care in the entire health care system, particularly the co-ordination of triage systems for suspected cases, disease prevention and health promotion, improvement of health literacy of the community, alternate sources of care for patients in secondary care, surveillance, and close monitoring of suspected cases and/or close contacts. clinical audits should be conducted to assess whether the actions are being implemented effectively and to identify barriers of implementing such actions in order to enact remedial solutions. we are convinced that implementation of the table roles of general practitioners in preparing for and responding to pandemics phase phase - running and coordination co-ordination of triage system for suspected cases. liaison with national/local health authority for prioritisation of primary health care during pandemic. standardisation of procedures in handling suspected cases and cautious cases. chair of gp network participates and gives advice in national/sub-national crisis committee. action plan to avoid cross infection of suspected cases and other patients. co-ordination of care at primary care level for large influx of influenza patients and patients with other illness. co-ordination of other sectors to care for large number of ill patients. provide local leadership in rational use of multi-sectoral resources in meeting the local health needs and demand. identify the vulnerable and at risk groups for necessary 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the general practitioner's response to pandemic influenza: a qualitative study infection prevention and control during health care for confirmed, probable, or suspected cases of pandemic (h n ) virus infection and influenza-like illnesses pre-publication history the pre-publication history for this paper can be accessed here cite this article as: lee and chuh: facing the threat of influenza pandemic -roles of and implications to general practitioners the authors would like to express sincere thanks to alpha lee for his kindest assistance in editing the manuscript. authors' contributions al is a general practitioner and an academic in the field of general practice and public health. his ideas of the paper come from researching, working experience with who as temporary advisor on many occasions, training of health professionals in disease prevention and health promotion, review of current evidence, and experience as general practitioner in different settings. ac is a general practitioner and an academic in general practice. his ideas of the paper come from researching, community services, training of health professionals, review of current literature, and experience as a general practitioner. both are authors of the paper and contributed to initial idea, and to the serial drafts and agreed the final submission. the author declares that they have no competing interests. key: cord- -a r gjc authors: dubb, s.s. title: coronavirus pandemic: applying a whole-of-society model for the whole-of-the world date: - - journal: br j oral maxillofac surg doi: . /j.bjoms. . . sha: doc_id: cord_uid: a r gjc during a pandemic, a national government is often considered solely responsible for dealing with the outbreak with local-based policies. a whole-of-society approach to a pandemic is evidence-based and used successfully in countries with a history of pandemic infections. this collaborative approach assumes that no single entity has the capacity to successfully manage the dynamic, complex problems that arise in a pandemic environment. application of the whole-of-society model globally would provide a more harmonious and concerted response with mutual and synergistic benefits to all affected nations. central entities within the model include; civil society, business and government. these are addressed at the community, local government and sub-national level. nine essential services are also identified including health, defence, law & order, finance, transport, telecommunication, energy, food and water. a continuing cycle of readiness, response and recovery of services encapsulates this model. pandemics affect the whole of the world, a global whole-ofsociety approach is therefore needed to tackle them. fritz described "disaster" as being a concentrated event in time and space in which society undergoes disruption such that essential functions are impaired. this disruption occurs on multiple levels; osterholm describes even in a mild pandemic the catastrophic loss of life and devastating impact on world economy, potentially lasting for several years. the cost of preparedness, an estimated $ . billion per year, is dwarfed by the estimated $ billion annual pandemic costs. such disasters and their inevitable consequences occur as the situation exceeds beyond the protective measures placed to contain it. international cooperation remains * corresponding author. e-mail address: ssd @ic.ac.uk fundamental and despite improved general medical care and institutional plans pandemics continue to overwhelm these public health protocols. as witnessed during this current coronavirus pandemic crisis and past pandemics; although the responsibility of control falls upon the country affected by the outbreak there does not currently exist a foolproof singular response system. . these emerging infection threats are made more potent by the increasing international transportation modalities upon which we have come to depend on. lessons have been learned from past pandemics and an evidence-based plan now exists. the world health organisation (who) first proposed a whole-of-society (wos) preparation plan in with risk management update in based upon lessons learned from the a(h n ) pandemic. , , in this model they describe central entities; government, civil society and business with surrounding essential services such as health, defense and food. these are all managed by a continuum of readiness, response and recovery (fig. ) . on declaring the coronavirus pandemic on march th dr. tedros adhanom ghebreyesus, who director-general stated: "this is not just a public health crisis, it is a crisis that will touch every sector, so every sector and every individual must be involved in the fights" is this too complex of a problem to tackle from a local systems perspective let alone on a world scale? complexity within healthcare systems has been described as individual agents able to act independently and unpredictably, their actions are interconnected and become defined by these same interactions. we are naturally used to working within a well-oiled rigid system with specific targets and outcomes, meeting them allows us to level up in the game of healthcare. complex systems in reality are more akin to the matrix; some rules can be bent, others can be broken with rigid boundaries being more blurred than clear. the features of a pandemic are not dissimilar to the features of complexity within a health system; the rapid pace and changing narrative of spreading infection; decisions based on inadequate, incomplete or debated data and adaptive solutions to fix local problems. is a surgical mask superior to an ffp mask? the roth score is widely used one week only to be discounted the next, does wearing theatre shoe covers have any evidence-based impact on reducing infection? the medical research council (mrc) itself adapted to this challenge evolving from rigid randomised control trials to including non-linear, mixed-method approaches to aid in the answering of these questions. as with the wos approach that utilises a multivariate approach this is reflected in the guidance and approach to dealing with complex problems in healthcare itself. the wos approach aims to utilize the principles of complexity within systems and seeks to improve the global effort against pandemic infections, increase information sharing and further institutionalize pandemic responses. although simple in theory, executing such measures requires national, political and local involvement incorporating the entirety of society, the so-called wos pandemic collaboration. this collaborative approach incorporates public agencies including but not limited to businesses, philanthropic organisations, communities and the entire public as a whole. this collaborative approach assumes that no single entity has the capacity to successfully manage the dynamic, complex problems that arise in a pandemic environment. pan-collaboration allows for responses to local changes and appropriate allocation of resources to meet national requirements. despite this well-versed plan on paper, lockdowns initiated as per the advice from the who protocols initially appeared draconian with many countries still not following recommendations of widespread testing, strict quarantine, contact tracing and social distancing. the now ubiquitous and familiar social distancing protocols, restricted transport and hand-hygiene measures were sluggishly adopted in italy, spain and the usa amongst others which in hindsight appear poorly judged decisions. the uk itself went through several different strategies starting with "contain-delay-mitigate-research", a plan that overlooked the who recommendation of testing and "detect, protect and treat". the new plan now aims to "suppress-shield-treat-palliate". another phrase that comes to mind is "singing from the same hymn sheet", a wos approach applied on a global scale would aim to mitigate the plethora of policy changes adopted with every country effectively trying to re-invent the wheel unnecessarily. italy as a case example went from its' discovery of the first official coronavirus case to the biggest crisis it has faced since world war ii within the space of weeks. many other countries have unfortunately suffered the same fate demonstrating not a lack of available knowledge but failure to efficiently and systematically execute this knowledge. from a political perspective pandemics, with their tendency to start small but exponentially and dramatically increase, represent a tightrope walk. strict and systematic measures are best undertaken early before cases are even officially confirmed. in retrospect, these actions would inevitably appear as overreactions if the interventions are successful. partial solutions, however, have been shown to fail time and again with confirmation bias a significant confounder when making daily objective assessments of infection progression. , from a governing body perspective a unified message of preparedness, not panic, is required with prudence overriding politics. an important aspect of this collaborative approach is trust and situation awareness. during the h n pandemic in taiwan, despite mass production of a vaccine, a negative media story centred around the death of a physicians' son led to a significant loss of trust. not only were vaccinations refused but this lack of trust then also extended to government recommendations and inhibited protective measures. situation awareness, so easily lost on a macro-scale again reflects the dynamic, ever-changing environment that is not dissimilar to an operating room . errors on a local level but magnified on a national and international setting may occur often because of tunnel vision toward achieving a particular action or goal to the exclusion of all other factors. conversely, relevant information may be present yet ignored due to distraction or hierarchy or a combination of these factors. examples of this may include panic-buying items despite no suggestion of shortage in supplies or ability to access, listening to local evidence and policy to the exclusion of globally available information and changing events. a government plea for businesses to help in the manufacture and production of ventilators was met with positive pledges from multiples businesses, related and not, to aid in the production of these vital machines. an important aspect missed in the early rush to produce more physical machines was the awareness of training need, recognising the deployment of healthcare workers from a familiar to an unfamiliar environment and different devices having different operational instructions. this very human and relevant clinical factor applies equally to the rapid production of safe machines that make it easy to use under considerable stress and pressure. to this end, further guidance has been appropriately released for a rapidly manufactured ventilator system specification that is minimally, clinically acceptable. other successful collaborations include that of telecommunication companies. these have recently committed to combined resources to support the government and nhs with broadband and mobile network services to support the almost overnight conversion of physical gp and outpatient appointments to remote and digital consultations. a real-life example of the wos model at work can be seen in the h n influenza pandemic. as the who raised the pandemic alert level the taiwanese government, using the wos model utilized many of the measures across multiple entities that we have started to witness in the uk also. this included mass school closure with public education through mass media, enhanced border controls, enhanced border controls and a mass vaccination programme. retired healthcare workers, volunteers and active members of the workforce were also readily mobilized as part of their preparedness measures. more localized examples of this included containment strategies utilized across cities and the triaging process of patients within the hospital. in the former, the city was segregated into sub-districts and districts led by a mayorappointed official. using six sigma principles of breaking down a complex process into smaller, simpler steps these districts were given allocations based on infection status. a "hot zone" for infection outbreaks, "intermediate zones" as buffers and lastly "cold zones" for no outbreaks. checkpoints limited interzonal traffic and isolated outbreaks within a cold zone were transported to isolated hospitals for treatment. triaging of patients for hospital often took place outside of the hospital environment. clear zones of contamination with confirmed cases, clean zones and disinfection stations in between these clearly marked areas. the starkest example of the effectiveness of these measures when followed and when not is that of lombardy and veneto, neighbouring regions within italy of similar socioeconomic profiles. lombardy has suffered , deaths in its' population of million compared to deaths in veneto's population of million. obvious confounders such as population density have played a part however lombardy and veneto adopted opposing public health strategies. whilst lombardy adopted a more relaxed approach veneto undertook many of the wos measures that included extensive testing, proactive tracing of cases and widespread quarantine. at-risk populations including healthcare workers, pharmacists, supermarket cashiers and other essential exposure-prone workers were specifically targeted. the wos model mobilized on the global canvas has untold potential benefits that we have already started to witness. the who-led solidarity trial is a global, coordinated research effort combining worldwide expertise for the discovery of potential treatments of coronavirus. similarly, unicef, who and the coalition for epidemic preparedness innovations (cepi) have combined their efforts, raising funds to help across multiple levels including protective equipment for health workers, mitigate the considerable societal impacts; education, health and safety among others. these are true examples of facet of the wos model applied across the whole of the world and what can be achieved. the occurrence of any pandemic, by definition, is panic inducing and responsibility is often considered to be solely of the governing body within that country. past pandemics have demonstrated that mobilizing all aspects of society in a collaborative effort has dramatically improved results. the most effective response requires an orchestrated, systematic approach undertaken simultaneously rather in partial measures. a whole-ofsociety-approach applied on the global canvas characterizes the most effective response to a global pandemic; the combined efforts of society undertaking a multitude of effective actions undertaken harmoniously and simultaneously. q [ ] . no conflicts complexity science: the challenge of complexity in health care actor management in the development of health financing reform: health insurance in south africa collaborative governance in theory and practice world health organisation. who guidelines for pandemic preparedness and response in the nonhealth sector offline: covid- and the nhs-"a national scandal lessons from italy's response to coronavirus pandemic risk: how large are the expected losses? mass psychogenic illness in nationwide in-school vaccination for pandemic influenza a(h n ) , taiwan situation awareness in anesthesia: concept and research leading article: what can we do to improve individual and team situational awareness to benefit patient safety? department of health & social care. rapidly manufactured ventilator system specification media & sport and the rt hon oliver dowden cbe mp. industry and government joint statement on telecommunications support for the nhs toward a collaborative model of pandemic preparedness and response: taiwan's changing approach to pandemics from sars in to h n in : lessons learned from taiwan in preparation for the next pandemic world health organisation. who and unicef to partner on pandemic response through covid- solidarity response fund i would like to thank professor trisha greenhalgh, professor of primary care sciences, nuffield department of primary care health sciences for her insight, support and advice in primary care and public health for this paper. i would like to thank professor peter a brennan, consultant maxillofacial surgeon & honorary professor of surgery for his insight, support and advice in clinical human factors. key: cord- -jfd gd p authors: bong, choon-looi; brasher, christopher; chikumba, edson; mcdougall, robert; mellin-olsen, jannicke; enright, angela title: the covid- pandemic: effects on low- and middle-income countries date: - - journal: anesth analg doi: . /ane. sha: doc_id: cord_uid: jfd gd p coronavirus disease (covid- ) is spreading rapidly around the world with devastating consequences on patients, health care workers, health systems, and economies. as it reaches low- and middle-income countries, its effects could be even more dire, because it will be difficult for them to respond aggressively to the pandemic. there is a great shortage of all health care providers, who will be at risk due to a lack of personal protection equipment. social distancing will be almost impossible. the necessary resources to treat patients will be in short supply. the end result could be a catastrophic loss of life. a global effort will be required to support faltering economies and health care systems. mere anarchy is loosed upon the world. -william butler yeats, the second coming a s news of a novel viral illness in china emerged in january and until the day when the director general of the world health organization (who) declared a pandemic, those who live and work in low-and middle-income countries (lmics) held their collective breath. as the single red dot on the world map morphed into red dots in almost every country in the world, the enormity of the problems facing all countries, but especially those with serious economic and health resource challenges, became evident. in this special article, we outline what those problems might be and possible ways to address them. the new coronavirus, officially named severe acute respiratory syndrome coronavirus (sars-cov- ), probably emerged in november and first caused cases of pneumonia of unknown origin in wuhan, china. the spectrum of illness caused by sars-cov- is now called coronavirus disease . initially thought to be transmitted from an animal or bird source to humans, it is now clear that there is efficient and thus widespread human-to-human transmission via airborne droplets. despite a massive effort to contain the virus within china, it has disseminated throughout the world. as of march , , there have been , confirmed cases, in countries, with , deaths. the clinical spectrum of the disease is quite variable, ranging from undiagnosed asymptomatic infection through mild upper respiratory infection to severe viral pneumonia leading to respiratory failure and death. the incidence of respiratory failure in wuhan was % overall; of those patients who died, % had respiratory failure compared to % of those who survived. all of those who succumbed had sepsis, and % had acute respiratory distress syndrome (ards), while % of survivors had sepsis and % had ards. also noted in this wuhan cohort was a % prevalence of comorbidities in those who died, most commonly hypertension, diabetes mellitus, and coronary artery disease. increasing age was also associated with increased risk of death. overall, in-hospital mortality rate was %, and for those requiring mechanical ventilation, it was %. the disease has spread rapidly throughout the world. existing antiviral medications seem to be ineffective. the number of deaths from covid- is staggering. italy, which has become another major epicenter of the outbreak, is reporting, as of march , , a total of , cases with associated deaths. countries have closed their borders, enforced strict social isolation and quarantine procedures, and increased testing coronavirus disease (covid- ) is spreading rapidly around the world with devastating consequences on patients, health care workers, health systems, and economies. as it reaches low-and middle-income countries, its effects could be even more dire, because it will be difficult for them to respond aggressively to the pandemic. there is a great shortage of all health care providers, who will be at risk due to a lack of personal protection equipment. social distancing will be almost impossible. the necessary resources to treat patients will be in short supply. the end result could be a catastrophic loss of life. a global effort will be required to support faltering economies and health care systems. (anesth analg xxx;xxx: - ) the covid- pandemic: effects on low-and middle-income countries for the virus. travel has almost ceased worldwide. businesses have closed, and economies are almost collapsing. yet it seems the virus continues to spread, and health care systems are being overwhelmed. why are some countries responding better than others? china put in place extraordinary measures, including tracing and testing of covid- contacts, and major quarantine restrictions, which included a complete lockdown that prevented all travel and commerce in and out of the wuhan region. normal life was basically suspended. in contrast, singapore seems to have done better with a much less severe approach. singapore applied a comprehensive surveillance strategy early on in the outbreak, with rigorous tracing of all case contacts followed by rapid quarantining. it used widespread testing so a patient with any suspicion of covid- could be rapidly tested. strict infection control practices were instituted at health care facilities, and health care workers were provided with adequate personal protective equipment (ppe). communication of information to the population was clear and transparent. request for the public to exercise social responsibility in containing the spread of the virus was met with compliance. with these measures, singapore has been relatively successful in managing the outbreak; however, new cases are beginning to occur, likely from travelers returning home. as a result, singapore has now adopted more stringent measures on social distancing. in efforts to continue tracing covid- contacts, the government of singapore has developed a contact tracing app, "trace together," that works by bluetooth technology. singapore will make this freely available globally. italy, on the other hand, has been ravaged by this disease. , the mean age of those who have died has been years, and more than two-thirds of these individuals were past smokers or had chronic disease such as diabetes mellitus, cardiovascular disease, or cancer. in spite of widespread aggressive measures imposed by the italian government, the incidence and death rate continue to rise. it is clear that, even in countries with strong economies and sturdy health care systems, there can be variable responses and case fatality rates with the outbreak. at this point, it seems that the sars-cov- has spread to almost every country in the world. even though many lmics have closed their borders to prevent travel-related dissemination, it is merely a matter of time before community-level spread becomes the norm. lmics frequently have large populations living in overcrowded conditions where "social distancing" is impossible to maintain, where clean water is rarely available in every household, and where supplies of hand sanitizer are impossible to find. thus people living in lmics will generally be unable to follow the usual public health advice on how to reduce the spread of virus and infection. mr cyril ramaphosa, president of the republic of south africa, accurately described the pandemic as a "national disaster." one infected case in south korea was determined to have been responsible for secondary cases. with such rapid, exponential spread, the situation in lmics, refugee camps, and war-torn regions will be catastrophic. health care facilities in lmics will be overwhelmed by patients with covid- . they are already overcrowded with those suffering from pneumonia, human immunodeficiency virus (hiv), tuberculosis (tb), and malaria, and patients in need of surgical treatment. covid- testing will be useful in confirming that patients have a viral illness and therefore do not require precious antibiotics. hospital beds will be in short supply, but unlike well-off, high-income countries (hics), poorer countries will be unable to significantly reduce their surgical volumes to make room for covid- patients. this is because the largest segment of surgical volume in lmics is emergent and urgent surgeries that cannot be safely postponed. moreover, a large percentage of these cases are patients undergoing cesarean deliveries. , if cesarean deliveries are delayed or cancelled, there is a likely risk of worsening already high maternal and neonatal mortality rates. another major challenge will be the shortage of intensive care beds. even if they were abundant, there is a significant shortage of resources such as oxygen, ventilators, infusion pumps, and all of the other necessities for taking care of patients with severe respiratory failure. even water and electricity supplies cannot be relied on in lmics. that brings us to the most overwhelming shortage of all-namely, health care personnel, including physicians-especially, anesthesiologists, who are on the front lines of any pandemic like covid- . in many lmics, anesthesiologists take care of patients in intensive care units (icus). they will be called on to intubate sick patients in emergency departments and in the operating rooms, as will nonphysician anesthesia providers. these health care workers will be at extremely high risk for infection, as intubation is considered one of the highest-risk procedures when dealing with covid- patients. lessons learned from the sars epidemic in included the importance of full personal protection when performing high-risk procedures. this is already also clear from the current covid- pandemic, as there have been deaths of many health care professionals in both china and italy. , adequate ppe is mandated in all available guidelines for managing covid- patients. ppe is in enormous demand around the world, and procurement will thus prove especially difficult in lmics. the prospect of losing any of our already scarce colleagues to this disease is terrifying. just as the world was waking up to the necessity of having safe anesthesia and surgery as part of universal health care, , all of the efforts may be sidelined or derailed by an enemy < μm in diameter. in the midst of their own crisis, well-resourced governments and organizations should remember the needs of those less well-off. economies will be devastated all over the world. this is the time to consider debt erasure for countries most in need. the international monetary fund has committed us $ billion in interest-free loans to low-income countries. the united nations has released emergency funds to assist vulnerable countries in the fight. much more will be needed now and in the foreseeable future. the world economic forum has launched a covid action platform to pull together a public-private partnership to support action on the pandemic. it is likely that a fund similar to the global fund for hiv/acquired immune deficiency syndrome (aids), tb, and malaria will be needed to further support the development of medications and vaccines for covid- . a fund such as the us president's emergency plan for aids relief (pepfar) will be required to provide medications and vaccines when they become available. pepfar is the largest commitment ever made by government to address a single disease. nongovernmental organizations (ngos) that normally work in low-income countries also need to offer support and practical help. for example, the lifebox foundation, partnering with smile train and gradian health care, has secured pulse oximeters for distribution to countries most in need (k. torgeson, ceo lifebox, personal communication, march , ) . since most of the complications of covid- are respiratory, pulse oximeters will be essential in the management of patients. however, without reliable oxygen supplies, oximeters will not help. massive efforts will be needed to improve oxygen availability. these will include not only a steady supply of oxygen tanks with a reliable delivery service but also provision of new oxygen concentrators and regular maintenance of those already available. without oxygen, many lives will be unnecessarily lost. doctors without borders (médecins sans frontières, msf) is providing health education activities, distributing soap and ppe for health care workers, and reinforcing hygiene measures in all of its facilities. will other ngos step up to help? governments, departments of health, and medical professional organizations need to be providing clear and unequivocal information about covid- : how to prevent its spread, who needs to be tested for it, and how to manage it if one becomes infected. one of the major problems for lmics is communication. radio, television, and newspapers are no longer the main methods of conveying information. social media in all of its forms is much more likely to carry the message. who has recognized this and launched a messaging service in conjunction with whatsapp and facebook. people can access the service, ask questions, and get advice. many journals, for example, the lancet and the new england journal of medicine, are publishing all articles on covid- with free access to everyone. , the same is true for anesthesia journals like anesthesia & analgesia. likewise, the cochrane library is available for unrestricted access for all, with special collections on infection control measures and evidence relevant to critical care. uptodate (wolters kluwer, waltham, ma) is also providing open access to clinical content on covid- . there are many advisories and guidelines available on the management of covid- patients in the icu and operating suite. , most of them apply to countries with significant resources and strong health care systems. they often include links to other useful sites for information. for example, reference includes links to the who site, the us centers for disease control and prevention (cdc), and the public health agency for canada, all of which have very useful information available. most lmics will have to adapt these resource documents to their needs and to the availability of equipment and resources at their centers. we are including table and figures that may be useful for those working in areas where resources are scarce. the table emphasizes the key points in managing patients. figure offers some low-cost suggestions for creating or extending ppe. figure offers recommendations on oxygen therapy. in addition, we are recommending applying a very useful system for those working in icus. this rubric is very practical and contains many educational materials filed under an a, b, c system. the african federation for emergency hand washing: soap and water; alcohol-based sanitizer . dedicated triage and inpatient areas for covid- patients . personal protective equipment: practical, locally sourced . therapeutic plan: locally devised, known to and agreed on by all staff . oxygen: increased supplies, maintenance of existing sources medicine has also prepared a useful booklet for those working in lmics. unfortunately, there are no medications demonstrated to successfully treat covid- . work continues apace to find them. false claims may be made, which can result in fatal outcomes. in addition, normal medication supply chains may be severely affected by the worldwide shutdown of factories, leaving many patients unable to access their normal medication supplies. current treatment is supportive. in many mild cases, people may convalesce at home. however, the severe cases are placing enormous strain on hospitals because of their growing numbers and the large percentage of patients who are requiring intensive care management. these severe cases are posing the greatest threat to health care workers in terms of cross-infection, and their resource needs will outstrip those available in many low-resource environments. there will be many ethical challenges to be faced. guidance is available from several sources, and we suggest having clear agreement on the relevant issues as soon as possible. each center will have to make its own decisions based on its currently available resources. to answer this question, we can only rely on what has been learned from the ebola epidemic of - in west africa. according to a report of the united nations development group (undg), at that time, the epidemic was "the longest, largest, deadliest and most complex" in history. covid- is already orders of magnitude greater than this. the us cdc estimates that there were just under , infected patients and just over , deaths during the ebola epidemic of - in west africa. liberia lost % of its doctors, nurses, and midwives; sierra leone %; and guinea %. the epidemic set back the management of all health care services and especially treatment and control of tb, hiv, and malaria. the number of women giving birth in health centers in sierra leone dropped by %; cesarean delivery rate dropped by %. it is estimated that $ . billion was lost from the gross domestic product of the countries. the united states, the united kingdom, and germany donated over us $ . billion in aid. the undg observed that "the global community is ill prepared for a devastating pandemic like ebola, and the next pandemic should not take the world by surprise." how correct this prediction has been. another lesson to be learned from the ebola epidemic has to do with "health security." this will not be a term familiar to most people, but it certainly will become so. basically, health security means protection from threats to our health. with modern travel and globalization, an epidemic in west africa or china, or anywhere else in the world, can easily become a threat in another location far away. thus it is imperative that governments and supranational organizations like the who work together to reduce the risks everywhere. there are international health regulations that aim to stop the spread of infectious diseases. however, they need to be expanded and modernized to address the issues of our time. "collective health security is the sum of individual health security, and compels global action to provide individuals in all countries with access to essential health care. this is indispensable for achievement of individual health security and, therefore, collective health and human security." in the absence of specific, effective treatment and given a lack of resources in managing active covid- patients, prevention and early containment of the disease appear to be the most feasible option for lmics. as the global covid- situation unfolds and countries are forced to take unprecedented drastic measure, including border closures, travel bans, and social distancing, we will likely witness the devastating and profound impact of this pandemic not only in health care but also on the world economy. this will further reduce resources available for health care, not just in managing covid- patients, but also for those with many other major medical conditions. this will be particularly challenging for lmics. the recent catastrophic clinical scenarios in many hics, including italy, spain, france, the united states, and the united kingdom, caused by a shortage of ppe, as well as other vital material and human resources, are a solemn reminder that many lmics will be facing similar or likely much worse constraints and outcomes. in the midst of all this doom and gloom, thousands of volunteers work tirelessly to ensure that food and medical supplies reach the millions of our fellow human beings in lmics who need them. increased connectivity allows rapid sharing of information and resources, all of which could help in "flattening the curve" in an attempt to avoid overwhelming individual health care systems. in the end, we must rely on the generosity of mankind and the resilience of the human spirit. e specter of possible new virus emerging from central china raises alarms across asia tor-general-s-opening-remarks-at-the-media-briefing-oncovid clinical course and risk factors for mortality of adult inpatients with covid- in wuhan, china: a retrospective cohort study covid- -the search for effective therapy integrated surveillance of covid- in italy upward trajectory or flattening the curve? this is how countries are faring with covid- cases the global community needs to swiftly ramp up the response to contain covid- interrupting transmission of covid- : lessons from containment efforts in singapore software for singapore contact tracing app to be free for global use covid- and italy: what next? lancet who covid - situation report viruse/situation-reports/ -sitrep- -covid- . pdf?sfvrsn=d cb dd_ a ticking time bomb: scientists worry about coronavirus spread in africa transmission potential and severity of covid- in south korea emergency-to-elective surgery ratio: a global indicator of access to surgical care percentage of cesarean sections among total surgical procedures in sub-saharan africa: possible indicator of the overall adequacy of surgical care intensive care unit capacity in low-income countries: a systematic review challenges experienced by health care professionals working in resource-poor intensive care settings in the limpopo province of south africa the wfsa global anesthesia workforce survey covid- airway recommendations during airway manipulation. available at illness in intensive care staff after brief exposure to severe acute respiratory syndrome several young doctors in china have died of the coronavirus. medical workers are far more vulnerable to infection than the general population italian doctors tell stories of sorrow and hope. globe and mail global surgery : evidence and solutions for achieving health, welfare, and economic development world health organization. wha . : strengthening emergency and essential surgical care and anaesthesia as a component of universal health coverage. geneva: who world health assembly donor funding for the global novel coronavirus response un releases emergency funds to help vulnerable countries fight coronavirus covid- covid- : what is msf doing? available at new health alert service launched with whatsapp the lancet: covid- resource center coronavirus (covid- ). available at covid- ) -cochrane rsources and news uptodate ® clinical content available to all choong see k. preparing for covid- : an early experience from an intensive care unit in singapore covid- recommendations during airway manipulation quick icu training for covid- . the critical care education pandemic preparedness (ccepp) team. available at: www.quickicutraining emergency care of covid- in adults in low resource settings. african federation for emergency medicine two nigerians overdose self-medicating with chloroquine after trump praised anti-malarial drug as possible covid- treatment indian pharma threatened by covid- shutdowns in china fair allocation of scarce medical resources in the time of covid- socio-economic impact of ebola virus disease in west african countries cost of the ebola epidemic effects of the ebola outbreak on antenatal care and delivery outcomes in liberia: a nation-wide analysis global health security: the wider lessons from the west african ebola virus disease epidemic key: cord- -mc pifep authors: rowhani-farid, anisa; allen, michelle; barnett, adrian g. title: what incentives increase data sharing in health and medical research? a systematic review date: - - journal: res integr peer rev doi: . /s - - - sha: doc_id: cord_uid: mc pifep background: the foundation of health and medical research is data. data sharing facilitates the progress of research and strengthens science. data sharing in research is widely discussed in the literature; however, there are seemingly no evidence-based incentives that promote data sharing. methods: a systematic review (registration: . /osf.io/ pz e) of the health and medical research literature was used to uncover any evidence-based incentives, with pre- and post-empirical data that examined data sharing rates. we were also interested in quantifying and classifying the number of opinion pieces on the importance of incentives, the number observational studies that analysed data sharing rates and practices, and strategies aimed at increasing data sharing rates. results: only one incentive (using open data badges) has been tested in health and medical research that examined data sharing rates. the number of opinion pieces (n = ) out-weighed the number of article-testing strategies (n = ), and the number of observational studies exceeded them both (n = ). conclusions: given that data is the foundation of evidence-based health and medical research, it is paradoxical that there is only one evidence-based incentive to promote data sharing. more well-designed studies are needed in order to increase the currently low rates of data sharing. electronic supplementary material: the online version of this article (doi: . /s - - - ) contains supplementary material, which is available to authorized users. research waste: hidden data, irreproducible research the foundation of health and medical research is data-its generation, analysis, re-analysis, verification, and sharing [ ] . data sharing is a key part of the movement towards science that is open, where data is easily accessible, intelligible, reproducible, replicable, and verifiable [ ] . data sharing is defined here as making raw research data available in an open data depository, and includes controlled access where data is made available upon request which may be required due to legal or ethical reasons. despite the wide-scale benefits of data sharing such as addressing global public health emergencies, it is yet to become common research practice. for instance, the severe acute respiratory syndrome (sars) disease was controlled only months after its emergence by a world health organization-coordinated effort based on extensive data sharing [ ] . likewise, the researchers working on the ebola outbreak have recently committed to work openly in outbreaks to honour the memory of their colleagues who died at the forefront of the ebola outbreak, and to ensure that no future epidemic is as devastating [ ] . notwithstanding these benefits, numerous studies have demonstrated low rates of data sharing in health and medical research, with the leading journal the british medical journal (bmj) having a rate as low as . % [ ] and biomedical journal articles % [ ] . there are of course legitimate reasons to withhold data, such as the concern about patient privacy, and the requirement for patient consent for sharing [ ] . with % of the world's spending on health and medical research, an estimated $ billion, wasted every year, it is clear that the scientific community is in crisis, leading to questions about the veracity of scientific knowledge [ ] . data sharing and openness in scientific research should be fundamental to the philosophy of how scientific knowledge is generated. thomas kuhn introduced the concept of paradigm shifts that arise from a scientific crisis. the paradigm shift before us today is from closed, hidden science to open science and data sharing [ ] . sharing scientific data will allow for data verification and re-analysis, and for testing new hypotheses. open data reduces research waste in terms of time, costs, and participant burden, and in turn, strengthens scientific knowledge by ensuring research integrity [ , ] . the many current problems in health and medical research have led to the emergence of a new field, metaresearch, which is concerned with improving research practices [ ] . meta-research has five sub-themes with 'reproducibility' and 'incentives' as two of the themes [ ] . reproducibility is concerned with the verification of research findings, which can be achieved through the sharing of data and methods [ ] . incentives is concerned with rewarding researchers, which includes incentives to share their data and methods [ ] . we were interested in how researchers are incentivised to openly share their raw data, thus combining two sub-themes of meta-research. historically, it has not been common practice for the content of a research article to include access to the raw data from scientific experiments [ ] . this flaw, created by technological limitations among others, has hindered the progress of scientific knowledge [ ] . however, we can no longer blame technology for outdated research practices. there are many data depositories which allow researchers to easily share their data using a citable doi. there have also been many recent policies and frameworks to encourage openness in research [ ] . yet, uptake in health and medicine is low and what is lacking, it appears, are rewards that incentivize researchers to share their data [ ] . incentives are defined here as rewards that are given to researchers if they participate in sharing their raw scientific data [ ] . the queensland university of technology (qut) library staff assisted in developing a rigorous and clearly documented methodology for both the search strategy and the selection of studies. the aim was to minimise bias by documenting the search process and the decisions made to allow the review to be reproduced and updated. the cochrane handbook for systematic reviews was used as a guide for this systematic review: http://handbook.cochrane.org/. the equator network additional file : prisma ( ) checklist [ ] was used to ensure good practice as well as accurate reporting. three systematic review registries (prospero, joanna briggs institute, and cochrane) were checked to ensure our proposed systematic review had not already been done. our systematic review protocol was registered at the open science framework on august (doi.org/ . /osf.io/ pz e). this review considered published journal articles with empirical data that trialed any incentive to increase data sharing in health and medical research. articles must have tested an incentive that could increase data sharing in health and medical research. for the purposes of this review, health and medical research data is defined as any raw data that has been generated through research from a health and medical facility, institute or organisation. incentives are defined here as 'a benefit, reward, or cost that motivates an […] action'. this was based on the definition of incentives in economics, which groups incentives into four categories: financial, moral, natural, and coercive [ ] . the review included any paper with empirical data on sharing that compared an intervention and control, which used a clear research design (including randomised and non-randomised designs). the types of measures included are the percent of datasets shared, or the number of datasets shared, or the relative ratio of data sharing. this review excluded the following, but still classified these excluded papers by field: all editorial and opinion pieces that only discuss strategies to increase data sharing without trialling them. strategies that do not involve incentives, e.g., education seminars, change in a data sharing policy or some other policy, access to data management tools and managers. observational studies that describe data sharing patterns. this search strategy was designed to access published articles through the following steps: ) ((("open science" or "open data" or "data sharing") and (incentive* or motivation* or reward* or barrier*))) ) ) relevant articles that did not appear in the database search but were known to the reviewers were handpicked and extracted into endnote. two reviewers, arf and ma, screened the titles of the articles and based on the inclusion and exclusion criteria, extracted them into endnote. duplicates were removed. the reviewers independently screened the extracted article titles and abstracts based on the inclusion and exclusion criteria and categorised them into five groups: arf read the titles and abstracts of all extracted articles and ma verified her findings by reading a random sample of %. discrepancies between the two reviewers were approximately %, however these were relatively minor and resolved through discussion of the scope of each of the categories. for instance, a research paper outlined the introduction of a data system, one reviewer classified it as an observational study, but after discussion it was agreed that it was a strategy article as its objective was to increase data sharing rates rather than observing data sharing patterns. the two reviewers independently read eligible documents and extracted data sharing incentives in health and medical research. both reviewers were agnostic regarding the types of incentives to look for. the final list of incentives was determined and agreed on by all authors [ ] . individual incentives were grouped into research fields. a qualitative description of each incentive was presented. based on our prior experience of the literature, the research fields and sub-fields for classification were: a. health and medical research i. psychology ii. genetics iii. other (health/medical) b. non-health and medical research i. information technology ii. ecology iii. astronomy iv. other (non-health/medical) the other article-strategies, opinion pieces, and observational studies were also grouped into the same research fields. the database searches found articles, of which met the inclusion criteria based on assessment of titles and abstracts and were exported into endnote. after automatically removing duplicates, articles remained and after manually removing the remainder of the duplicates, articles remained. titles and abstracts were read and categorised based on the above inclusion and exclusion criteria. one study was hand-picked as it met the inclusion criteria, bringing the total number of extracted articles to . after screening titles and abstracts, nine articles were classified under incentives in health and medical research. these articles were then read in full, and one of them was judged as an incentive that satisfied the inclusion criteria. the prisma [ ] flow chart that outlines the journey of the articles from identification to inclusion is in fig. . the categorisation of all articles into the sub-fields and article type is in table . a review of the reference list for the one included intervention was undertaken [ ] . the titles and abstracts of the full reference list of this study ( papers) and those that cited the study ( papers) were read, but none met the inclusion criteria of this systematic review. articles were irrelevant, bringing the total number of screened articles to . the distribution of articles across type of study was similar for both health and medical research and non-health and medical research ( table ) . observational studies were the most common type (n = , n = ), then opinion pieces (n = , n = ), then articles testing strategies (n = , n = ), and articles testing incentives were uncommon (n = , n = ). these articles did not fit the inclusion criteria, but based on the abstracts they were mostly concerned with observing data sharing patterns in the health and medical research community, using quantitative and qualitative methods. the motivation behind these studies was often to identify the barriers and benefits to data sharing in health and medical research. for instance, federer et al. ( ) conducted a survey to investigate the differences in experiences with and perceptions about sharing data, as well as barriers to sharing among clinical and basic science researchers [ ] . these articles also did not fit the inclusion criteria, but based on the abstracts they were opinion and editorial pieces that discussed the importance and benefits of data sharing and also outlined the lack of incentives for researchers to share data. open data and open material badges were created by the center of open science and were tested at the journal psychological science [ ] . [ ] . a limitation of the badge study was that it did not use a randomized parallel group design; notwithstanding, it was the only incentive that was tested in the health and medical research community, with pre-and postincentive empirical data [ ] . the pre-and post-design of the study makes it vulnerable to other policy changes over time, such as a change from a government funding agency like the recent statement on data sharing from the australian national health and medical research council [ ] . however, the kidwell et al. study addressed this concern with contemporary control journals. a limitation of the badge scheme was that even with badges, the accessibility, correctness, usability, and completeness of the shared data and materials was not %, which was attributable to gaps in specifications for earning badges. in late , the center for open science badges committee considered provisions for situations in which the data or materials for which a badge was issued somehow disappear from public view and how adherence to badge specifications can be improved by providing easy procedures for editors/journal staff to validate data and material availability before issuing a badge, and by providing community guidelines for validation and enforcement [ ] . of the non-health/medical incentives, seven were categorised as information technology, and nine as other. upon reading the full text, all the non-health/medical incentives were proposed incentives or strategies as opposed to tested incentives with comparative data. given that the systematic review found only one incentive, we classified the data sharing strategies tested in the health and medical research community. seventy-six articles were classified under 'strategies' and table shows the further classification into categories based on a secondary screening of titles and abstracts. the articles are grouped by whether they presented any data, descriptive, or empirical. the majority, / , of strategies were technological strategies such as the introduction of a data system to manage and store scientific data. seven of the strategies concerned encouraging collaboration among research bodies to increase data sharing. eight were a combination of collaboration across consortia and the introduction of a technological system. three had a data sharing policy as the strategy but did not test the effectiveness of the policy, but two of them reported descriptive data from their experience in implementing the policy. one strategy was an open data campaign. below we give some examples of the strategies used to promote data sharing. two articles discussed an incentive system for human genomic data and data from rare diseases, namely, microattribution and nanopublication-the linkage of data to their contributors. however, the articles only discussed the models and did not present empirical data [ , ] . another article discussed the openfmri project that aims to provide the neuroimaging community with a resource to support open sharing of fmri data [ ] . in , the openfmri database had full datasets from seven different laboratories and in october , the database had datasets openly available (https://openfmri.org/dataset/). the authors identified credit as a barrier towards sharing data and so incorporated attribution into the openfmri website where a dataset is linked to the publication and the list of investigators involved in collecting the data [ ] . an article discussed open source drug discovery and outlined its experience with two projects, the praziquantel (pzg) project and the open source malaria project [ ] . the article did not have pre-and post-strategy data. the authors discussed the constituent elements of an open research approach to drug discovery, such as the introduction of an electronic lab notebook that allows the deposition of all primary data as well as data management and coordination tools that enhances community input [ ] . the article describes the benefits and successes of the open projects and outlines how their uptake needs to be incentivised in the scientific community [ ] . an article discussed the development of the collaboratory for ms d (c-ms d), an integrated knowledge environment that unites structural biologists working in the area of mass spectrometric-based methods for the analysis of tertiary and quaternary macromolecular structures (ms d) [ ] . c-ms d is a web-portal designed to provide collaborators with a shared work environment that integrates data storage and management with data analysis tools [ ] . the goal is not only to provide a common data sharing and archiving system, but also to assist in the building of new collaborations and to spur the development of new tools and technologies [ ] . one article outlined the collaborative efforts of the global alzheimer's association interactive network (gaain) to consolidate the efforts of independent alzheimer's disease data repositories around the world with the goals of revealing more insights into the causes of alzheimer's disease, improving treatments, and designing preventative measures that delay the onset of physical symptoms [ ] . in , they had registered data repositories from around the world with over , subjects using gaain's search interfaces [ ] . the methodology employed by gaain to motivate participants to voluntarily join its federation is by providing incentives: data collected by its data partners are advertised, as well as the identity of the data partners, including their logos and url links, on each gaain search page [ ] . gaiin attributes its success in registering data repositories to date to these incentives which provide opportunities for groups to increase their public visibility while retaining control of their data, making the relationship between gaiin and its partners mutually beneficial [ ] . this study did not have pre-and post-strategy empirical data, but described the importance of incentives in motivating researchers to share their data with others [ ] . an article described how data sharing in computational neuroscience was fostered through a collaborative workshop that brought together experimental and theoretical neuroscientists, computer scientists, legal experts, and governmental observers [ ] . this workshop guided the development of new funding to support data sharing in computational neuroscience, and considered a conceptual framework that would direct the data sharing movement in computational neuroscience [ ] . the workshop also unveiled the impediments to data sharing and outlined the lack of an established mechanism to provide credit for data sharing as a concern [ ] . a recommendation was that dataset usage statistics and other user feedback be used as important measures of credit [ ] . one article addressed the need to facilitate a culture of responsible and effective sharing of cancer genome data through the establishment of the global alliance for genomic health (ga gh) in [ ] . the collaborative body unpacked the challenges with sharing cancer campaign ( ) [ ] genomic data as well as the potential solutions [ ] . the ga gh developed an ethical and legal framework for action with the successful fostering of an international 'coalition of the willing' to deliver a powerful, globally accessible clinic-genomic platform that supports datadriven advances for patients and societies [ ] . an article discussed the efforts of the wellcome trust sanger institute to develop and implement an institutewide data sharing policy [ ] . the article outlined that successful policy implementation depends on working out detailed requirements (guidance), devoting efforts and resources to alleviate disincentives (facilitation), instituting monitoring processes (oversight), and leadership [ ] . the topic of disincentives (facilitation) included concerns about lack of credit [ ] . they propose that cultural barriers to data sharing continue to exist and that it is important to align the reward system to ensure that scientists sharing data are acknowledged/cited and that data sharing is credited in research assessment exercises and grant career reviews [ ] . one intervention was an open data campaign which was included in the review via an open letter in june from the alltrials campaign to the director of the european medicines agency to remove barriers to accessing clinical trial data [ ] . the alltrials campaign is supported by more than , people and organisations worldwide [ ] . this letter contributed to the european medicines agency publishing the clinical reports underpinning market authorization requests for new drugs, which was part of a more proactive policy on transparency that applied to all centralized marketing authorisations submitted after january [ ] . the adoption of this policy was a significant step in ensuring transparency of health and medical research in europe [ ] . this systematic review verified that there are few evidence-based incentives for data sharing in health and medical research. the irony is that we live in an evidence-based world, which is built upon the availability of raw data, but we hardly have any evidence to demonstrate what will motivate researchers to share data. [ ] . it is interesting to note the great number of opinion pieces (n = ) on the importance of developing incentives for researchers, which outnumbered the number of articles that tested strategies to increase data sharing rates (n = ). 'opinion pieces' are mutually exclusive from 'strategies' as the former is concerned with discussing possible strategies and incentives and the latter tests the ideas and strategies and provides evidence of what works or does not work. these strategies included: the introduction of data systems such as electronic laboratory notebooks and databases for data deposition that incorporated a system of credit through data linkage; collaboration across consortia that also introduce data systems that also use data attribution as an incentive; collaboration across consortia through workshops and development of frameworks for data sharing; implementation of data sharing policies; and campaigns to promote data sharing. these strategies discussed the requirement of introducing rewards to increase data sharing rates and the only form of incentive used was via data attribution and advertising on websites. studies that test the effectiveness of attribution and advertising as a form of credit are necessary. in light of the small number of studies, we see a clear need for studies to design and test incentives that would motivate researchers to share data. organisations are promoting the development of incentives to reduce research waste. in late , the cochrane and the reward alliance combined to create the annual cochrane-reward prize for reducing waste in research. the monetary prize is awarded to 'any person or organisation that has tested and implemented strategies to reduce waste in one of the five stages of research production [question selection, study design, research conduct, publication, and reporting] in the area of health'. this prize is an example of an incentive for researchers to design studies or implement policies that reduce research waste; it will be interesting to see the impact of this initiative [ ] . another endeavour in the area of developing incentives and rewards for researchers is the convening in early of a group of leaders from the usa and europe from academia, government, journals, funders, and the press to help develop new models for academic promotion and professional incentives that would promote the highest quality science, organised by the meta-research innovation center at stanford (met-rics). the focus will be on designing practical actions that embody principles that this community has embraced, while also recognizing that the effect of any such policies will need empirical evaluation. while the systematic barriers to widespread data sharing are being addressed through the general shift towards more openness in research, the conversation on data sharing includes an alternative view where users of shared data are called 'research parasites' who 'steal from research productivity' and who are 'taking over' [ , ] . there is also some questioning of whether data sharing is worth the effort [ ] . these points, however, are contrary to the purpose of sharing data, which is to progress science as a body of knowledge and to make the research process more robust and verifiable [ , ] . a limitation of this systematic review is that we did not search the grey literature (materials and research produced by organizations outside of the traditional commercial or academic publishing and distribution channels). this review could be perceived as having a narrow design, given that we anticipated a lack of evidence-based incentives for data sharing in health and medical research, hence making the topic of this systematic review too simple. however, we could not be sure that there were no incentives and the recent paper by lund and colleagues ( ) emphasises the importance of conducting systematic reviews prior to designing interventions in order to avoid adding to the already large issue of research waste [ ] . the current meta-research discourse outlines the numerous benefits of openness in research: verification of research findings, progressing health and medicine, gaining new insights from re-analyses, reducing research waste, increasing research value, and promoting research transparency. however, this systematic review of the literature has uncovered a lack of evidencebased incentives for researchers to share data, which is ironic in an evidence-based world. the open data badge is the only tested incentive that motivated researchers to share data [ ] . this low-cost incentive could be adopted by journals and added to the reward system to promote reproducible and sharable research [ , ] . other incentives like attribution require empirical data. instead of evidence-based incentives, the literature is full of opinion pieces that emphasize the lack of incentives for researchers to share data, outweighing the number of strategies that aim to increase data sharing rates in health and medicine. observational studies that identify data sharing patterns and barriers are also plentiful, and whilst these studies can provide useful background knowledge, they do not provide good evidence of what can be done to 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harnessing the innovative power of the semantic web to explore the genetic basis of diseases brisk-research-oriented storage kit for biologyrelated data isa-tab-nano: a specification for sharing nanomaterial research data in spreadsheet-based format usage: a web-based approach towards the analysis of sage data. serial analysis of gene expression a universal open-source electronic laboratory notebook grin-global: an international project to develop a global plant genebank information management system padma database: pathogen associated drosophila microarray database all the world's a stage: facilitating discovery science and improved cancer care through the global alliance for genomics and health scens: a system for the mediated sharing of sensitive data the us-mexico border infectious disease surveillance project: establishing binational border surveillance medetect: domain entity annotation in biomedical references using linked open data open science cbs neuroimaging repository: 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studies one health surveillance -more than a buzz word? xnat central: open sourcing imaging research data flexible specification of data models for neuroscience databases health care provider quality improvement organization medicare data-sharing: a diabetes quality improvement initiative the global alzheimer's association interactive network (gaain) pediatric patients in the track tbi trial-testing common data elements in children rapid learning in practice: validation of an eu population-based prediction model in usa trial data for h&n cancer developing the foundation for syndromic surveillance and health information exchange for yolo county, california. online journal of public health informatics the national academies collection: reports funded by national institutes of health new models of open innovation to rejuvenate the biopharmaceutical ecosystem, a proposal by the acnp liaison committee the preclinical data forum network: a new ecnp initiative to improve data quality and robustness for (preclinical) neuroscience data sharing in neuroimaging research sharing data with physicians helps break down barriers. data strategies & benchmarks : the monthly advisory for health care executives sharing overdose data across state agencies to inform public health strategies: a case study act levels the playing field on healthcare performance the qut librarians assisted in designing the search strategy for this review. no monetary assistance was provided for this systematic review; however, support was provided in kind by the australian centre for health services innovation at the institute of health and biomedical innovation at qut. the datasets generated and analysed during the current study are available at the open science framework repository (doi . /osf.io/dspu ). authors' contributions arf collected and analysed all the data for the study and wrote the manuscript. ma collected the data and analysed ( %) for the study and edited the manuscript. agb provided close student mentorship for this research, which is a part of arf's phd under his primary supervision, and was a major contributor for the writing of this manuscript. all authors read and approved the final manuscript. the authors declare that they have no competing interests. not applicable.ethics approval and consent to participate not applicable. key: cord- -q kqjvvf authors: moghadas, seyed m; haworth-brockman, margaret; isfeld-kiely, harpa; kettner, joel title: improving public health policy through infection transmission modelling: guidelines for creating a community of practice date: journal: can j infect dis med microbiol doi: nan sha: doc_id: cord_uid: q kqjvvf background: despite significant research efforts in canada, real application of modelling in public health decision making and practice has not yet met its full potential. there is still room to better address the diversity of the canadian population and ensure that research outcomes are translated for use within their relevant contexts. objectives: to strengthen connections to public health practice and to broaden its scope, the pandemic influenza outbreak research modelling team partnered with the national collaborating centre for infectious diseases to hold a national workshop. its objectives were to: understand areas where modelling terms, methods and results are unclear; share information on how modelling can best be used in informing policy and improving practice, particularly regarding the ways to integrate a focus on health equity considerations; and sustain and advance collaborative work in the development and application of modelling in public health. method: the use of mathematical modelling in public health decision making for infectious diseases workshop brought together research modellers, public health professionals, policymakers and other experts from across the country. invited presentations set the context for topical discussions in three sessions. a final session generated reflections and recommendations for new opportunities and tasks. conclusions: gaps in content and research include the lack of standard frameworks and a glossary for infectious disease modelling. consistency in terminology, clear articulation of model parameters and assumptions, and sustained collaboration will help to bridge the divide between research and practice. l'amélioration des politiques de santé publique par la modélisation de la transmission des infections : des directives pour créer une communauté de pratique historique : malgré l'ampleur des recherches au canada, la mise en oeuvre de la modélisation n'a pas encore atteint son plein potentiel en santé publique dans la prise de décision et la pratique. il y a matière à mieux intégrer la diversité de la population canadienne et d'utiliser les résultats de la recherche dans les contextes pertinents. objectifs : pour renforcer les liens avec l'exercice de la santé publique et en élargir la portée, l'équipe de pandemic influenza outbreak research modelling s'est associée au centre de collaboration nationale des maladies infectieuses pour organiser un atelier national. cet atelier visait à déterminer les secteurs où la terminologie, les méthodo-logies et les résultats de la modélisation manquent de clarté, à transmettre de l'information sur l'utilisation optimale de la modélisation pour étayer les politiques et améliorer la pratique, notamment en accordant plus d'importance aux questions d'équité en santé, et à maintenir et faire progresser la collaboration pour élaborer et mettre en oeuvre la modélisation en santé publique. mÉthodologie : l'atelier sur l'utilisation de la modélisation mathématique dans la prise de décision relative aux maladies infectieuses en santé publique a réuni des chercheurs modélisateurs, des professionnels de la santé publique, des décideurs et d'autres experts du pays. les conférenciers ont mis en contexte les discussions dans le cadre de trois séances. une dernière séance a suscité des réflexions et des recommandations sur les futures tâches et possibilités. conclusions : les lacunes en matière de contenu et de recherche incluent l'absence de cadres standardisés et de glossaire de la modélisation des maladies infectieuses. une terminologie uniforme, la formulation claire des paramètres et des hypothèses de modélisation ainsi qu'une collaboration soutenue contribueront à corriger l'écart entre la recherche et la pratique. seyed m moghadas phd , margaret haworth-brockman msc , harpa isfeld-kiely ma , joel kettner md research defines a mathematical model as a framework "representing some aspects of reality at a sufficient level of detail to inform a clinical or policy question" ( ). mathematical, computational and statistical models and techniques have been applied in the canadian public health system, especially after the severe acute respiratory syndrome (sars) epidemic, but it is unclear to what degree their outcomes have been used to shape policy and improve practice. furthermore, the diversity of the canadian population has not been adequately addressed in public health models, and research outcomes are often not translated for use within their relevant contexts. to improve the applicability and impact of models in public health, it is necessary to understand areas where modelling results are unclear, the value of a common language between modelling and public health, and how to sustain and enhance the application of modelling in public health. established during the early stages of the h n pandemic in canada, the pandemic influenza outbreak research modelling (pan-inform) team has a mandate to develop innovative modelling frameworks and knowledge translation methods that inform public health by linking theory, policy and practice. aligned with its mandate, on october and , , pan-inform held its fourth biannual workshop ( ) ( ) ( ) cohosted by the national collaborating centre for infectious diseases. this workshop brought together public health this open-access article is distributed under the terms of the creative commons attribution non-commercial license (cc by-nc) (http:// creativecommons.org/licenses/by-nc/ . /), which permits reuse, distribution and reproduction of the article, provided that the original work is properly cited and the reuse is restricted to noncommercial purposes. for commercial reuse, contact support@pulsus.com practitioners and leading research modellers (a list of attendees is available at <http://pan-inform.yorku.ca/events/pan-inform-workshop- / participants.html>) to enhance cross-discipline communications by providing a forum for knowledge to flow freely in a 'jargon-free' setting. the expected outcome was to identify the infrastructure, expertise and resources necessary to establish a 'communities of practice' (cop) network. the cop concept, initially developed by jean lave and etienne wenger, refers to groups of people who share a concern, a set of problems or a passion about something they do, and learn how to do it better by interacting regularly ( ) ( ) ( ) ( ) . the proposed cop, as a new initiative to be catalyzed from this workshop, would offer new approaches to addressing problems at different levels of health care and population health and enable the development of strategic plans to move evidence to action. an important role for this cop is to develop a common language that can be used in understanding the outcomes of health research and disease modelling. the workshop objectives were to: understand areas where modelling terms, methods and results are unclear; share information on how modelling can best be used in informing policy and improving practice, particularly regarding the ways to integrate a focus on health equity considerations; and sustain and advance collaborative work in the development and application of modelling in public health. the two-day event unfolded in four sessions. the first two, "modelling in public health: opportunities and challenges" and "mathematical modelling in public health practice", helped to set the context regarding scientific methods and research applications, particularly for the evaluation of research uptake and provided public health perspectives on the utility of modelling in decision making. the third session, "muddling through modelling: communication, common language and health equity", spurred discussion regarding the need for common language between researchers and knowledge users, to improve the use of modelling study results. this included foundational issues regarding access to data and the involvement of indigenous and other community representation. in the final session, "developing our network and communities of practice", participants reflected on earlier presentations and discussions to clarify what is needed to continue collaboration and knowledge exchange that can increase the value of research modelling in public health. the presentations and discussions that ensued created compelling arguments that the most prominent and observable outcomes can be achieved when communication barriers between disciplines are eliminated. the present report discusses key presentations and discussions that took place, and summarizes the outcomes and action plans that emerged from the workshop. setting the context: opportunities and challenges for modelling in public health sessions and of the workshop began with a presentation regarding the development of infectious diseases modelling in canada. before the sars epidemic, modelling activities were largely driven by research interests of individuals or small groups, with a significant emphasis on the theoretical aspects of exploring complex mathematical phenomena. for the most part, these activities were carried out in isolation, with minimal communication and engagement with public health professionals and policymakers ( ) . during and following the sars epidemic, various groups of disease modellers were formed to engage with, and develop models for application to public and population health in more specific contexts. despite the importance and relevance of these initiatives, knowledge translation remained a challenge that the pan-inform was established in part to address ( ). the canadian institutes of health research supported the establishment of pan-inform to address the limited knowledge exchange between modelling researchers and those who could potentially make use of models to inform health policy and improve practice. since its inception, pan-inform has undertaken several national initiatives for knowledge brokering, including the evaluation of canada's response to the spring and winter waves of the novel h n pandemic, identification of strategies for protecting vulnerable populations from emerging infectious diseases, and development of approaches that can enrich existing links with aboriginal health organizations and foster multijurisdictional collaborative efforts in canada ( ) ( ) ( ) . in canada, public health decision making occurs within orders of government at all levels. situations are often very complex for a number of reasons including the availability and adequacy of health resources; inconsistent or absent evidence regarding the effectiveness and cost effectiveness of intervention strategies; pressure from the public, media and government under which public health must operate; other competing public health services; and ethical considerations to balance the protection of community health against individuals' rights and freedoms. other pertinent challenges include the lack of data to estimate potential outcomes of a public health program, paralysis resulting from having too much information on occasion, differing opinions and short timelines. in this context, as one presenter put it, there are three questions decision makers face: what is the benefit of the public health program or intervention; who will benefit from the program and; is the program cost-effective? often, the evidence to answer these questions is not available in a timely manner. ideally, one would address these questions by investigating the effects experimentally. however, controlled trials may not be feasible or ethical, and can also be time consuming, laborious, expensive or inconclusive. models provide a useful tool to overcome these challenges and systematically evaluate possible effects by using existing data and knowledge, generating quantitative outcomes and mapping out interdependencies that may be key factors for determining policy needs. given these capabilities, models can be used to identify key uncertainties in the parameters and generate qualitative predictions, such as the effect of behavioural changes on the trends and distribution of an infection in the population. indeed, the overarching goal of modelling is to support evidence-based public health policy. to enhance the utility of models, communication and collaboration between modellers and public health leaders must take place early in a decision making process. models are more valuable when end users are engaged in formulating the questions because models are built so that they truly reflect a public health question. end users who understand a model are likely to be better able to assess the results. during the construction and validation of a model, the relevance and importance of input parameters must be understood, and the sources for their values and ranges, uncertainty about the parameters, and sensitivity of the model outcomes with respect to parameter variation and original model assumptions, must be determined. new knowledge generated by a model should address the target question and be translated and disseminated for uptake and action appropriate to the context. furthermore, when data are limited, it is essential to quantify any uncertainty in parameterization, because different sets of parameters may fit equally well. ideally, the process to improve the model structure and its outcomes is iterative. the value of direct conversations between modellers and public health leaders, in particular with regard to the availability and access to data and other critical information that are essential for model inputs of real-time scenarios ( ) , was exemplified in the use of modelling and the implementation of model recommendations for antiviral use and vaccination in canada's response to the h n pandemic ( , ) . table summarizes key issues presented and discussed for modelling in public health during the workshop. the international society for pharmacoeconomics and outcome research guidelines highlight the importance of a common language for drafting a health decision question and addressing it through a modelling framework. the guidelines for transparency and validation state: every model should have non-technical documentation that is freely accessible to any interested reader. at a minimum, it should describe in nontechnical terms, the type of model and intended applications; funding sources; structure of the model; inputs, outputs, other components that determine the model's function and their relationships; data sources, validation methods and results; and limitations ( ). good communication flows to and from knowledge producers and users, and requires a common language to build effective partnerships and understanding of the groups' respective concerns. there are a number of challenges to developing a common language: determining a common lexicon; understanding priorities and contributions, which may shift depending on the political climate or population health status; asking the right questions that are appropriate to the given context; knowing the right audience; and being able to communicate findings to others outside the research community. the lack of such common language may have been an impediment to addressing key parameters in 'determinants of health' and 'health equity'. in the canadian context, one needs to take into account differential health status and population structure of first nations, inuit and métis people, population-level patterns of abuse, poverty and historical trauma, challenges regarding access to health services in rural and remote areas, and limits in identifying "vulnerable" populations in available datasets with no real markers. building partnerships and an iterative exchange allows for goals and facts to be clearly identified, and outcomes to be assessed for their value to inform decisions about the potential benefits and risks of policy development and program delivery. effective partnerships require willingness and commitment, alignment of values, mechanisms to engage early and continuously, and plans to regularly review goals, objectives, roles, and responsibilities and outcomes. a recent review of literature highlights the inconsistency in definitions and interpretations of epidemiological terms in several modelling studies and the need for common language to sustain and enhance the application of models in public health ( ) . the review found that disparate outcomes and interpretations for policy decisions may arise from inconsistent use of terms in model structures, even when the assumptions and input parameters are identical. discrepancies in how terms are used for modelling are generally associated with two main reasons. first, it is often assumed that the particular terms are well defined or well understood. for example, 'infectiousness' and 'infectious' were found to be used interchangeably; the former describes a characteristic of the disease and/or how readily the disease is transmitted, while the latter describes a patient state ( ) . second, definitions of some terms have drifted over time as understanding of the mechanisms of disease processes and control has evolved. for example, the way terms such as 'prevention', 'protection' and 'reduced susceptibility' are used related to communicable disease may lead to different results depending how they are used in modelling. developing a common modelling has an important place in public health policy and practice. the utilization of modelling has been far less that its potential in the canadian context create a national infrastructure or network in canada to develop useful and applicable models based on realistic assumptions and quality data closer working relationships collaboration, engagement and exchange between modellers, and policymakers are needed to facilitate iterative processes that optimize the value and understanding of models and their results identify partners at the provincial level within acute care, emergency services and public health divisions. formalize exchange processes for regular communication and education applying health equity and other lenses limited attention has been paid to using health equity or sex and gender analyses. the availability of aboriginal-specific information has been inconsistent at best modellers and users can be called on to create model frameworks and ask questions that will provide better information about where there are inequities and inequalities. involve the people who understand equity issues data quality and access access to good-quality, population level data is essential to validate a model and its outcomes. such data may not necessarily be available or accessible in a timely fashion during an emerging infectious disease evaluate data quality and the type of information provided by surveillance for its potential to be used for research modelling. engage with provinces to determine the nature and availability of data required for modelling standardization of approaches to develop useful models, three aspects of the modelling will need to be standardized: what (ie, frameworks that are context specific and take into account the population demographic and geographic characteristics); who (ie, involvement of policymakers, knowledge users and modellers with relevant expertise), and how (ie, develop an iterative process from the formulation of health policy questions to the dissemination of model outcomes) a communities of practice network can be tasked with the standardization of this process to ensure that synergies exist when models are formulated to inform clinical or health policy decisions roles and responsibilities clarification on the roles of health agencies and jurisdictions are needed to engage partners from academic institutes, government health organizations and health industries national collaborating centre for infectious diseases will lead the initiative to forge the linkages and develop appropriate channels and effective methods of communication between the involved partners capacity some jurisdictions lack modelling capacity. there is also a lack of information about which modellers are available to work with public health and their expertise a centralized list or network could contribute to greater capacity for public health jurisdictions. develop opportunities for public health personnel to learn more about models and their value language will help to reduce possible variation in study results produced by different research communities. this will in turn decrease misinterpretation of the outcomes by allowing for comparisons of scientific evidence from multiple disciplines involving health research, and helping knowledge users and policymakers to better understand research outcomes and their applicability to policy and practice. there are other factors responsible for variation in model findings, including different strategies or approaches and assumptions, different population demographic variables, and the objectives for evaluating policy effectiveness that can vary from one situation to another. the latter can be exemplified in two recent studies on the effectiveness of school closure during pandemic influenza outbreaks. when assessing the effect of school closure strategies in reducing community attack rates, halder et al ( ) found that due to the difficulty in determining the true degree of epidemic spread and its severity in the early stages of an outbreak, a strategy of individual school closures would be more effective than simultaneous closures across a region. the outcomes are drawn from an agent-based simulation model of albany, a small community in western australia with a popula tion of approximately , individuals. in contrast, to evaluate the impact of local reactive school closures on critical care provision in the united kingdom population setting, house et al ( ) concluded that school closures should be coordinated in time (simultaneous) and location (all schools within a school district) to become an effective strategy to reduce infection transmission and, consequently, relieve capacity pressures of hospital intensive care unit admissions. the population demographics and the objectives for closing schools are distinctly different between the two studies, suggesting that different modelling approaches are required for measuring the effectiveness of school closures. understanding scenario-specific outcomes and their applications requires a critical evaluation to address the following questions: • is the methodology appropriate for the specific population setting? • do the assumptions and parameters address the reality of demographic and geographic characteristics? • can the outcomes be compared with other studies and validated with observed data? • how generalizable are the outcomes to address different scenarios or population settings? a consensus emerged during the workshop regarding the need to develop a common language for modelling to enhance its application in a public health context and promote bidirectional communication ( table ). to address this need, the fourth session of the workshop provided an opportunity for participants to discuss the establishment and potential impact of a community of practice. during the final discussion session, a number of important issues related to the development of a cop network were discussed, including its structure and governance, leadership and research capacity, memberships and partnerships, strategic plans for sustainability and resources, and the impact and uptake of outcomes (table ) . the october national workshop propelled new discussion on the value of mathematical models in public health planning and the need for greater cohesion and collaboration among stakeholders. the workshop concluded with a consensus among participants that there is work to be done and a willingness to continue to work together. the creation of a common lexicon is a tangible, initial task that should be undertaken as an immediate response to the workshop discussions. we expect that through sustained cross-disciplinary dialogues, a cop will initially produce a 'book of terminology' that describes current usage and proposes common terminology (community standards) in different areas, including medical and infectious diseases epidemiology, public health and disease modelling. this reference book can then be updated regularly when new terms need clarification for shared understanding and agreement in use. furthermore, in times of uncertainty, the virtual cop network will provide opportunities to access, analyze, synthesize and utilize reliable information and databases in a timely fashion, and drive a broad consensus around plausible alternatives and integrated courses of action. it is also true, however, that ongoing discussions between modellers and public health personnel will help to clarify language use and break down perceived barriers. ispor-smdm modeling good research practices task force. modeling good research practices-overview: a report of the ispor-smdm modeling good research practices task force- managing public health crises: the role of models in pandemic preparedness canada in the face of the h n pandemic indigenous populations health protection: a canadian perspective the development, design, testing, refinement, simulation and application of an evaluation framework for communities of practice and social-professional networks communities of practice: an opportunity for interagency working communities of practice: learning, meaning and identity pandemic influenza outbreak research modelling team (pan-inform), fisman d. modelling an influenza pandemic: a guide for the perplexed pandemic influenza: modelling and public health perspectives available at <www.cihr-irsc.gc. ca/e/ .html> (accessed on annex e. the use of antiviral drugs during a pandemic review of terms used in modelling influenza infection developing guidelines for school closure interventions to be used during a future influenza pandemic modelling the impact of local reactive school closures on critical care provision during an influenza pandemic modelling for public health (mod ph) <www.linkedin.com/ groups? within a number of weeks after the workshop, a new virtual community of practice, created by national collaborating centre for infectious diseases through linkedin, called mod ph (modelling for public health) ( ) key: cord- - n n p b authors: javed, bilal; sarwer, abdullah; soto, erik b.; mashwani, zia‐ur‐rehman title: the coronavirus (covid‐ ) pandemic's impact on mental health date: - - journal: int j health plann manage doi: . /hpm. sha: doc_id: cord_uid: n n p b throughout the world, the public is being informed about the physical effects of sars‐cov‐ infection and steps to take to prevent exposure to the coronavirus and manage symptoms of covid‐ if they appear. however, the effects of this pandemic on one's mental health have not been studied at length and are still not known. as all efforts are focused on understanding the epidemiology, clinical features, transmission patterns, and management of the covid‐ outbreak, there has been very little concern expressed over the effects on one's mental health and on strategies to prevent stigmatization. people's behavior may greatly affect the pandemic's dynamic by altering the severity, transmission, disease flow, and repercussions. the present situation requires raising awareness in public, which can be helpful to deal with this calamity. this perspective article provides a detailed overview of the effects of the covid‐ outbreak on the mental health of people. consigned people to stay in their homes to help break the chain of transmission. however, the restrictive measures undoubtedly have affected the social and mental health of individuals from across the board. as more and more people are forced to stay at home in self-isolation to prevent the further flow of the pathogen at the societal level, governments must take the necessary measures to provide mental health support as prescribed by the experts. professor tiago correia highlighted in his editorial as the health systems worldwide are assembling exclusively to fight the covid- outbreak, which can drastically affect the management of other diseases including mental health, which usually exacerbates during the pandemic. the psychological state of an individual that contributes toward the community health varies from person-to-person and depends on his background and professional and social standings. quarantine and self-isolation can most likely cause a negative impact on one's mental health. a review published in the lancet said that the separation from loved ones, loss of freedom, boredom, and uncertainty can cause a deterioration in an individual's mental health status. to overcome this, measures at the individual and societal levels are required. under the current global situation, both children and adults are experiencing a mix of emotions. they can be placed in a situation or an environment that may be new and can be potentially damaging to their health. | children and teens at risk children, away from their school, friends, and colleagues, staying at home can have many questions about the outbreak and they look toward their parents or caregivers to get the answer. not all children and parents respond to stress in the same way. kids can experience anxiety, distress, social isolation, and an abusive environment that can have short-or long-term effects on their mental health. some common changes in children's behavior can be : • excessive crying and annoying behavior elderly people are more prone to the covid- outbreak due to both clinical and social reasons such as having a weaker immune system or other underlying health conditions and distancing from their families and friends due to their busy schedules. according to medical experts, people aged or above are more likely to get the sars-cov- and can develop a serious and life-threatening condition even if they are in good health. physical distancing due to the covid- outbreak can have drastic negative effects on the mental health of the elderly and disabled individuals. physical isolation at home among family members can put the elderly and disabled person at serious mental health risk. it can cause anxiety, distress, and induce a traumatic situation for them. elderly people depend on young ones for their daily needs, and self-isolation can critically damage a family system. the elderly and disabled people living in nursing homes can face extreme mental health issues. however, something as simple as a phone call during the pandemic outbreak can help to console elderly people. covid- can also result in increased stress, anxiety, and depression among elderly people already dealing with mental health issues. family members may witness any of the following changes to the behavior of older relatives ; • irritating and shouting behavior everyone may feel differently and have a different welcome by society when they come out of quarantine. people who recently recovered may have to exercise social distancing from their family members, friends, and relatives to ensure their family's safety because of unprecedented viral nature. different age groups respond to this social behavior differently, which can have both short-and long-term effects. health workers trying to save lives and protect society may also experience social distancing, changes in the behavior of family members, and stigmatization for being suspected of carrying covid- . previously infected individuals and health professionals (dealing pandemic) may develop sadness, anger, or frustration because friends or loved ones may have unfounded fears of contracting the disease from contact with them, even though they have been determined not to be contagious. however, the current situation requires a clear understanding of the effects of the recent outbreak on the mental health of people of different age groups to prevent and avoid the covid- pandemic. • understanding the effects of the covid- outbreak on the mental health of various populations are as important as understanding its clinical features, transmission patterns, and management. • spending time with family members including children and elderly people, involvement in different healthy exercises and sports activities, following a schedule/routine, and taking a break from traditional and social media can all help to overcome mental health issues. • public awareness campaigns focusing on the maintenance of mental health in the prevailing situation are urgently needed. psychiatrists beware! the impact of covid- and pandemics on mental health. psychiatric times is pakistan's response to coronavirus (sars-cov- ) adequate to prevent an outbreak? front med who warning on lockdown mental health sars-cov- pandemics: the lack of critical reflection addressing short-and long-term challenges mental health and coping during covid- patients with mental health disorders in the covid- epidemic looking after your mental health during the coronavirus outbreak. mental health foundation mental health considerations for children quarantined because of covid- concerns for the mental health of children and adolescents during the coronavirus pandemic covid- and the consequences of isolating the elderly an expert explains: how to help older people through the covid- pandemic how to protect older people from the coronavirus. the new york times the authors declare no potential conflict of interest. https://orcid.org/ - - - key: cord- -eqn kl p authors: drissi, nidal; ouhbi, sofia; janati idrissi, mohammed abdou; ghogho, mounir title: an analysis on self-management and treatment-related functionality and characteristics of highly rated anxiety apps date: - - journal: int j med inform doi: . /j.ijmedinf. . sha: doc_id: cord_uid: eqn kl p background and objective: anxiety is a common emotion that people often feel in certain situations. but when the feeling of anxiety is persistent and interferes with a person's day to day life then this may likely be an anxiety disorder. anxiety disorders are a common issue worldwide and can fall under general anxiety, panic attacks, and social anxiety among others. they can be disabling and can impact all aspects of an individual's life, including work, education, and personal relationships. it is important that people with anxiety receive appropriate care, which in some cases may prove difficult due to mental health care delivery barriers such as cost, stigma, or distance from mental health services. a potential solution to this could be mobile mental health applications. these can serve as effective and promising tools to assist in the management of anxiety and to overcome some of the aforementioned barriers. the objective of this study is to provide an analysis of treatment and management-related functionality and characteristics of high-rated mobile applications (apps) for anxiety, which are available for android and ios systems. method: a broad search was performed in the google play store and app store following the preferred reporting items for systematic reviews and meta-analysis (prisma) protocol to identify existing apps for anxiety. a set of free and highly rated apps for anxiety were identified and the selected apps were then installed and analyzed according to a predefined data extraction strategy. results: a total of anxiety apps were selected ( android apps and ios apps). besides anxiety, the selected apps addressed several health issues including stress, depression, sleep issues, and eating disorders. the apps adopted various treatment and management approaches such as meditation, breathing exercises, mindfulness and cognitive behavioral therapy. results also showed that % of the selected apps used various gamification features to motivate users to keep using them, % provided social features including chat, communication with others and links to sources of help; % offered offline availability; and only % reported involvement of mental health professionals in their design. conclusions: anxiety apps incorporate various mental health care management methods and approaches. apps can serve as promising tools to assist large numbers of people suffering from general anxiety or from anxiety disorders, anytime, anywhere, and particularly in the current covid- pandemic. education, and relationships [ , ] . the exact causes of anxiety disorders are still unknown. according to the national institute of mental health, it is likely to be a combination of genetic and environmental factors [ ] . other possible factors that can lead to susceptibility include brain chemistry, personality type, exposure to certain mental and/or physical disorders, trauma and stress [ ] . the covid- outbreak, in addition to being a public health emergency, is also affecting mental health in individuals on a global scale causing people to suffer from stress, anxiety, and depression [ , ] . the pandemic is also triggering feelings of fear, worry, sadness, and anger [ , ] . quarantines, self-isolation, fear of the unknown, loss of freedom and other factors are causing psychological issues in people around the world [ , ] . these situations and circumstances can trigger several anxiety disorders, mainly separation anxiety disorder which is defined as fear of being away from home or loved ones, illness anxiety disorder which is defined as anxiety about a person's health (formerly called hypochondria) [ ] and panic attacks that are affecting a large number of people because of excessive worrying. psychiatric patients are additionally at a higher risk of experiencing symptoms related to psychological issues caused by the pandemic [ ] . people with preexisting anxiety disorders are showing aggravation of their conditions, for example, many people with ocd are developing new fixations on the covid- virus and are experiencing compulsive cleaning [ ] . due to the covid- pandemic, social interactions have significantly decreased in several parts of the world. while this may have provided relief to some people with social anxiety, it is possible this lack of interaction may have negative consequences in the longer term [ ] . returning to work after a period of lockdown, while still in the state of pandemic, is also causing the workforce to exhibit symptoms related to ptsd, stress, anxiety, depression and insomnia [ ] . the current covid- situation is also affecting the mental well-being of health care workers, who are at a high risk of psychological distress [ ] , especially those who are experiencing physical symptoms [ ] . the situation is further worsened by the recommended avoidance of inperson contact and fear of infection, as people with anxiety and other mental disorders might not be able to consult with a mental health professional. there are various barriers to mental health care delivery, such as cost, stigma, lack of mental health care professionals, and distance from health care services [ , ] . mobile mental health or m-mental health, which uses mobile technologies for providing mental health services, has the potential to help overcome mental health care delivery barriers, as it provides anonymous access to care, low to no cost care, and remote communication. smartphones can be a convenient tool to reach a large number of people from different parts of the world. there are many mobile applications (apps) for mental health problems such as ptsd [ , ] , stress [ ] , depression [ ] and alcohol dependence [ ] , as well as other health issues such as obesity, that apps can help with, especially due to lack of exercise during circumstances similar to the current lockdown [ ] . smartphone apps have high rates of acceptance among the general public, and especially in young people [ ] due to its cost effectiveness [ ] . many studies have reported that apps have shown positive results in the treatment and management of anxiety [ , , ] . this study aims to analyze the functionality and characteristics of highly j o u r n a l p r e -p r o o f rated anxiety apps to identify users' preferred features and management methods delivered for anxiety with a smartphone or a tablet. for the purposes of this study, only free apps were selected, as recent statistics in march showed that . % of android apps and . % of ios apps were freely available worldwide [ ] . a total of apps, android apps, and ios apps were selected. the anxiety management approaches used in these apps among other aspects of functionality have been extracted and analyzed. this section presents the methodology that was followed in order to select and analyze android and ios anxiety apps. this paper follows the quality reporting guidelines set out by the preferred reporting items for systematic reviews and meta-analysis (prisma) group to ensure clarity and transparency of reporting [ ] . google play repository and the app store were used as sources to select anxiety apps. both app repositories are very popular with a high number of available health care apps: more than , apps are available in the google play store, and more than , apps are available in the app store [ ] . a general search string, composed of only one word "anxiety", was used. it was automatically applied to the titles and descriptions of android and ios apps. j o u r n a l p r e -p r o o f each app from the search result was examined by the first author to decide whether or not to be included in the final selection. the second author revised the final apps selection. the following inclusion criteria (ic) were applied: • ic : anxiety related apps in google play store and app store. • ic : apps that have a free version. • ic : apps that have + stars rating. ic reflects a level of user satisfaction with the app. the focus is on highly rated anxiety apps so as to discover the functionality features and characteristics that provide high user satisfaction. the following exclusion criteria (ec) were applied to the candidate apps to identify the final selection that would be included in this study: • ec : apps that have less than raters. • ec : apps that could not be installed. • ec : apps that crashed and could not be used after installation. apps that match any of the ec were excluded from the selection. ec is based on the heuristic guideline by nielsen [ ] , which recommends having five evaluators to form an idea about the problems related to usability. the apps' selection process was established as follows: . the search string was used to identify candidate apps in the google play store and app store in order to create a broad selection from which to choose from. . ic were used to identify relevant apps. . apps that met one or more of the ec were excluded. the above actions were carried out in march . a final selection of android apps and ios apps was identified after application of ic and ec. fig. presents the selection results. data collection was carried out using the data extraction form presented in table . each app was installed and assessed to explore its functionality features and characteristics. the devices used for the apps' assessment were: oppo a (android ), and ipad (ios ). a template was designed in an excel file to provide basic information about the apps as well as specifying their main features and functionality characteristics. some of these characteristics and functionality features were retrieved from the app's description available in the app repository. this section presents and discusses the results of this study. a total of apps, android apps, and ios apps were identified as both free and highly rated apps. tables a. , a. , a. , a. , a. and a. in appendix present general information about the apps such as name, link, rating, number of raters, number of installations (not available for ios apps), and date of latest update. the majority of the selected apps ( %) offer in-app purchases for paid features and functionality. these apps are free to download and use, but many of their proposed functionality features are not available without purchase. thus, it can be said that users may not fully benefit from the app unless they purchase these specific features. however, it should also be noted that in-app purchases are a way for many developers to monetize their work j o u r n a l p r e -p r o o f apps general information: -name of the app. -date of the latest update. -users rating (scored out of ): to report the level of user satisfaction from the apps. -number of raters: to report the number of raters satisfied with the app. -number of installations (not available for ios apps): to identify the most installed apps. -in-app purchase: to identify whether free apps charge users for certain functionality features. -management method: to identify management and treatment methods for anxiety that could be delivered through an app, and the most used ones in the available apps. -intervention approach: to identify approaches that could be transmitted through an app, and the most followed approaches in the available apps. -targeted mental problem/symptoms: to identify anxiety related issues addressed by the apps and issues that might be managed with similar management methods and approaches as ones for anxiety, as well as to identify problems that could be treated and managed through apps. -involvement of mental health care professional: this information was extracted from apps' descriptions in-app repositories and from apps' content. we consider mental health care professionals to be those professionals with a mental health background including psychiatrists, therapists, counselors and experts in psychological issues or management methods. -physical health information such as hr and bp: to identify whether the app relies on physical indicators to assess the mental status of the user. -authentication method: to identify if the app provides users with the option to keep their personal health data inaccessible to other users of the same device. -gamification features: to identify whether gamification features are included in the app to encourage and motivate the users to keep using it. -social features which might include: links to communities, associations, and centers; interoperability with other apps or websites; the possibility to share content via social networks (sn); and contact information in case of emergencies. -languages: identify the availability of the apps in multiple languages, which reflects the degree of internationalization of the app. -offline availability: identify whether the app can be used without internet access. [ ] . the free version of the app is used by many developers as an advertisement tool to attract users into purchasing and unlocking more features [ ] . free apps with in-app options are becoming the norm in-app markets. in , in-app purchases accounted for more than % of ios app revenue in the us and % of revenue in asia [ ] . the majority of the selected apps ( %) updated their functionality and content in the three first months of . this could be linked to the current covid- pandemic situation. on december st, the who china office was informed of a number of pneumonia cases from an unknown cause, that were later linked to the coronavirus [ ] , which has now spread to all regions of the world [ ] . to limit the spread and risk of the virus, the who advised the public to practice social distancing and to stay home [ ] . many countries have declared obligatory lockdowns and people were quarantined, which has created a state of fear and worry that has elevated many individuals' anxiety and stress. various existing anxiety apps have, thus, been updated to include covid- related content. table presents various management methods identified in the selected anxiety apps with meditation and breathing exercises being the most common. the main goal of meditation is to help the user enter a deep state of relaxation or a state of restful alertness. it helps to reduce worrying thoughts, which play a key role in symptoms of anxiety, and bring about a feeling of balance, calmness, and focus [ ] . several studies have presented evidence supporting the use of meditation in anxiety treatments [ , , ] . one study reported that it was beneficial for a group of chinese nursing students j o u r n a l p r e -p r o o f meditation a , a , a , a , a , a , a -a , a , a , a , a -a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , i , i , i -i , i , i , i , i , i , i , i , i , i , i , i , i breathing exercises a , a , a , a , a , a , a , a a , a , a , , i i i i games a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , i , i , i , i , i -i , i , i , i , i , i -i , i , i , i assessment tests a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , i , i stories a , a , a , a , a , a , a , a , a , i , i , i , i , i , i , i mindfulness practices a , a , a , a , a , a , a , a , i , i , i , i , i , i , i , i guided relaxation a , a , a , a , a , a , a , a , a , a , i , i , i , i community chats with app users via the app a , a , a , a , a , a , a , a , a , a ,i yoga and physical exercises a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , i motivational and inspirational statements a , a , a , a , a , a , a , a , a ,i , i , i online therapy and coaching a , a , a , a , a , a , a , a i , i recommending activities and tips a , a , a , a , a , a , a , a ,i interactive messaging a , a , a , a in reducing anxiety symptoms and lowering systolic bp [ ] . another study reported that it showed improvements in the reduction of anxiety for breast cancer patients [ ] . a meta-analysis of controlled trials for the use of meditation for anxiety also reported a level of efficacy of meditative therapies in reducing anxiety symptoms [ ] . additionally, meditation has been shown to be effective in managing various types of anxiety such as panic disorder and agoraphobia [ ] . breathing exercises are another mechanism that can help to relax and relieve stress. while practicing deep breathing, a message is sent to the brain to calm down and relax. biochemical changes subsequently decrease hr and bp and help the person to relax [ ] . studies have shown that breathing exercises can improve cognition and overall well-being [ ] , while also reducing anxiety [ , , , , ] . breathing exercises can also have a positive impact on psychological distress, quality of sleep [ ] , depression [ , , ] , everyday stress, ptsd, and stress-related medical illnesses [ , ] . breathing exercises are also used to help with asthma, which was the case in a and a . however, it should be noted that such exercises may help patients whose quality of life is impaired by asthma, but they are unlikely to reduce the need for anti-inflammatory medication [ ] . many of the selected apps provided educational content about anxiety and other mental issues, symptoms, and management methods, either in the form of courses, articles, videos, or others. educating users about anxiety can help to reassure them and provide them with the necessary knowledge by answering questions and correcting misinformation that they might have. educating users about the provided management method and its benefits may also increase their trust in the management approach and their willingness to try it. mental assessment tests have been provided by some apps to give the user an idea about his/her mental status, anxiety, stress and/or depression levels. relaxing music and sounds, is a noninvasive and free of side-effects ap-proach that has been used in apps as a management method. it has been shown to be an effective tool for the reduction of anxiety, stress, and depression [ , ] . it has also shown positive results in the prevention of anxiety and stress-induced changes like hr and bp [ ] . developers should take into account the type of music and sounds used, as well as the accompanying environment, as they both affect the effectiveness of this method [ , ] . thirty-one apps provided journaling and writing diaries to help users plan their day, track their mood, and express their thoughts, feelings, and emotions. securing the privacy and confidentiality of users' information is critical in such apps. all selected ios apps providing journaling provide authentication methods, while only % of android apps with this functionality provide users with the same level of authentication. eleven apps provide the user with the possibility of communicating with other users. in these apps, users are able to share their experiences, talk about their issues, help each other, and relate to others who are undergoing similar problems as their own. in the current covid- pandemic, being in a state of isolation but having the ability to connect with an online community can be very helpful. the idea of enabling interaction with a community of people with similar issues is quite interesting and can be extremely helpful, especially given that people with anxiety often tend to avoid direct communication [ ] . for users who prefer communication with mental health care professionals, there are ten apps available that provide online therapy and coaching, enabling users to communicate with mental health care professionals, without having to travel, while also avoiding obstacles like stigma and distance. selected apps offering online therapy services charge fees for these services. these apps also provide information on the mental health care professionals' credentials. this information is important as it allows the user to check whether these professionals are appropriately accredited and decide which mental health care professional is most suited for his/her needs. thirty-three apps provide users with games like coloring books, puzzles, and slime simulations, as management methods for anxiety. these games help the user to relax, and to take his/her mind off worrying thoughts or feelings. games are usually enjoyable and entertaining and this may motivate users to continue using these apps. the variety of management methods identified in the selected apps points to the high potential of apps usage for coping with anxiety. developers have integrated various promising and effective management methods in their apps' functionality features. users can access these features at any time and in any place. this could be beneficial for users with anxiety disorders, especially in situations where immediate help is needed (e.g., during panic attacks), or in cases where mental health care professional cannot be reached due to circumstances like distance or the current global lockdown situation. table presents the selected apps which state the use of specific intervention approaches for anxiety management. the most used ones included mindfulness, cognitive behavioral therapy (cbt), and hypnosis. mindfulness was the most adopted management approach. it is defined as "bringing one's complete attention to the present experience on a moment-tomoment basis" [ ] . mindfulness practices allow practitioners to shift their concentration to their internal experiences occurring in each moment, such as anxiety and mood problems [ , ] , and improving an individual's internal cognitive, emotional, and physical experience [ ] . some findings suggest that mindfulness can be more complicated than it might seem, as many el-ements like attention emotional balance, differences in emotion-responding variables, and clinical context can influence its effect [ , , ] . therefore, these elements should be taken into account while developing mindfulnessbased anxiety apps. cbt is a form of psychological treatment, mainly based on efforts to change thinking patterns [ ] . many studies have supported the effectiveness of cbt-based interventions for the treatment of anxiety, and have reported on the long-term positive effect it has on both children and adults [ , ] . a study examining available evidence on cbt have yielded positive results and confirmed its effectiveness for anxiety disorders [ ] . cbt has also been used in the treatment of some specific anxiety disorders like ptsd [ ] and ocd [ ] . it has also been proved effective for depression, alcohol and drug use problems, eating disorders, and severe mental illness [ ] . cbt and mindfulness-based therapy can also be useful in reducing anxiety during the covid- pandemic [ ] . hypnosis is a therapeutic technique designed to bring relaxation and focus to the mind [ ] . many studies have reported the effectiveness of hypnosis for the treatment of anxiety. one study stated that it can reduce anxiety among palliative care patients with cancer [ ] , and another reported on its considerable benefits to terminally ill patients [ ] . hypnosis is also used to treat and manage stress and phobias [ ] , as well as sleep and physical symptoms [ ] . other approaches have also been identified in the selected apps as shown in table , but it should be noted that a few of them were not based on scientific approaches. table presents the different health issues besides anxiety that were addressed by the selected apps. all selected apps addressed general anxiety. some apps addressed specific types of anxiety like social anxiety, separation anxiety, performance anxiety, ocd, ptsd, and panic attacks. focus and concentration a , a , a , a , a , a , a , i , i , i self-esteem and confidence a , a , a , a , a , a , a , i , i , i , i , i pain a , a , a , a , a , a , a , i , i mood a , a , a , a , a , a , a , a , a some apps addressed other mental and physical issues, which usually occur with anxiety like stress [ , ] , sleep issues [ ] , and depression [ , , ] . some apps used management methods to treat addiction-related issues, eating disorders [ ] , phobias, [ ] , and asthma [ ] . the majority of the apps do not use physical health information. hr and bp are impacted by anxiety and stress [ ] . both can be used by apps to indicate the anxiety level of the user [ ] . yet in our selection only two apps provided this functionality feature (a and a ). a collects data on hr variability, using the photoplethysmogram (ppg) technique to get insights on the user's health, including stress, energy, and productivity levels. the app also allows the user to manually enter bp as a convenient way of journaling. it should be noted that a provides cardiovascular tests, including hr and peripheral blood circulation, as an app purchase option. only % of the selected apps reported involvement of mental health care professionals as presented in table . apps providing online therapy specified information about the therapists that the user can contact. this information includes their specialty, experience, and diplomas. some apps shown in table provided names of the professionals involved in their co-creation. providing names gives the user the possibility to look online for the credentials of the involved professionals and might increase the user's trust toward these apps. we cross-checked the names displayed in table and found them to be legitimate. table table presents the authentication methods identified in the selected apps. the majority of the selected apps ( %) do not require authentication. the absence of authentication might give the user a sense of anonymity. however, authentication can help the user ensure the privacy of his/her data. the app a requests a nickname and a password, ensuring security and confidentiality as well as keeping the anonymity of the user, since it does not use any information or sources that could reveal the identity of the user like facebook account, google account, or email. nickname and password a gamification is the use of game elements in non-gaming systems which are mainly used to improve user experience and user engagement [ ] . table presents the different gamification methods identified in the selected apps. note that some apps use more than one gamification method. the majority of the selected apps used gamification features to encourage and motivate the user. creating a fun, interactive user experience with the adoption of game elements can create an enjoyable user experience, which can further reduce boredom and motivate users keep using the app. this can also increase user engagement, leading to users providing more accurate information about their mental health status and to increased benefit for the user from the provided mental health care management method. gamification is a widely used approach that has shown effectiveness with anxiety and other mental health problems, such as depression and ptsd for military personnel [ , ] , and aggression for veterans [ ] . combining j o u r n a l p r e -p r o o f game a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , a , i , i , i , i -i , i , i , i , i , i -i , i , i , i graphics a , a , a , a , a , a , a , a , a , a , a , a , a unlocking new features a , a , i , i , i score and points a , a , a , i stickers, awards and stars a , a , a , a , i game elements and knowledge on game players' behaviors with known mental health care management methods is an interesting approach that can result in the creation of effective anxiety apps. table presents the different social features provided by the selected apps. many apps provide social and communication features, which allow the user to connect with communities of app users as well as with centers and associations, or with others to share content and progress. those social features could prove to be beneficial to the user. for instance, sharing progress and content from the app via social networks (sn) and emails helps provide social support to the user from family and friends. social support is significantly associated with well-being and absence of psychological distress [ ] . it has a favorable effect on certain psychological issues [ ] , and can serve as a mediator to stress and anxiety caused by life events [ ] . providing social support is also among the behavioral change techniques implemented in m-health apps to promote app usage [ ] . additionally, providing contacts in case of emergencies is crucial and might help the user in critical situations j o u r n a l p r e -p r o o f where he/she feels the need for immediate help. links to associations, websites, and centers can provide the user with more helpful resources. social features are very important as they help the user connect with others in a beneficial way. emergency contacts' information a , a , a , a , a , a , a , a , a group treatment i , i table presents the languages available in the selected apps. the majority of the apps ( app) are available only in english, which can be explained by the fact that the search string applied in app repositories was in english. only one app (a ) automatically translates its content to the device's preferred language. while the rest of the apps are available in more than one language. availability in multiple languages can help reach a larger number of users. i , i -i , i , i , i , i , i , i , i , i -i , i -i , i , i , i -i more than one language a , a , a , a , a , a -a , a , a , a , a , a , a -a , a , a , a , a , a , a , a , i , i , i , i , i , i -i , i , i , i , i , i , i system's languages a j o u r n a l p r e -p r o o f table shows whether an app requires internet access to function or not. internet access is required to install and create accounts for all apps, but once that is done, many apps function without internet access. offline availability is an aspect that will help users benefit from the app without necessarily being in a setting with internet access. this will decrease the app's limitations and make it more accessible to users. however, some of the management methods identified do require internet access, like online therapy and communication with communities of app users. additionally, offline availability may require downloading more data that could be permanently stored, which may affect a phone's memory and performance. some apps were only partially available offline, resulting in limited functionality when internet access was not available. other apps only made downloaded data available offline, meaning the user chooses and downloads content that he/she wants to be available while offline. these are convenient solutions to offline availability that do not compromise on app functionality. this study is subject to limitations, such as: (i) missing terms (e.g., stress, depression) in the search string that might have resulted in the selection of relevant apps, as usually an app targets more than one mental health issue. however, the search string used identified any app that mentions anxiety in its title and/or description, therefore this can alleviate the threat of missing relevant apps; and (ii) the first author conducted the search and applied the ec and ic to the initial selection. however, the final selection has been reviewed by the second author. with the current development in mobile communication and the wide ownership of mobile devices, m-mental health seems to be one of the most promising ways to deliver care to people in need regardless of their situation. under certain circumstances like the current covid- pandemic, the use of mobile communication and apps for anxiety might become a necessity. panic attacks can mimic covid- symptoms, which might worsen the condition of people with anxiety disorders [ ] . having an app on hand that can ease anxiety in such circumstances is useful. this study highlights the functionality and characteristics of anxiety apps that are well rated by users. we plan to build on the reported findings to develop a reusable requirements catalog for anxiety apps. mental health care professionals and people with anxiety disorders will be involved in the co-creation of this catalog. the catalog will also include software quality requirements based on the iso/iec standard and recommendations from the uk national health service (nhs) and the health insurance portability and accountability act (hipaa) on health apps. since the reusable requirements catalog for anxiety apps will be based on functionality of existing highly rated apps, as well-being based on inputs from mental health care professionals and people suffering from anxiety, it could be used to assist developers to select relevant requirements for anxiety apps. apps could therefore be designed based on the catalog to assist people dealing with anxiety. requirements from the catalog could also be used to generate checklists for audit and evaluation purposes [ ] , either to evaluate apps or to compare their functionality and characteristics. the findings from this study may also assist researchers and developers interested in the field of m-mental health, especially in the sub-field of anxiety, to have an overview of the characteristics and functionality of existing highly rated apps for anxiety. our findings could also assist mental health professionals to find anxiety apps that could be integrated in their mental health care process, as well as assist people suffering from anxiety to find mobile apps best suited for their needs. during the covid- pandemic, mhealth can also help disseminate health information among health personnel and community workers [ ] . all authors contributed to the creation of the manuscript. nd: design, conception, acquisition and interpretation of data, classification of selected apps, drafting of the manuscript, revision. so: design, conception, statisti- j o u r n a l p r e -p r o o f what was already known on the topic: -anxiety disorders are a common mental issue. -there are many barriers to mental health care delivery, mainly cost, stigma and distance from health professionals. -apps were found to be effective tools to deliver mental health care, and overcome the aforementioned barriers. what this study added to our knowledge: - free and high-rated anxiety apps were analysed: android apps, and ios apps. -anxiety apps addressed other health issues, such as: stress, depression, sleep issues, and eating disorders. -anxiety apps adopted various management, treatment and coping approaches such as, meditation, breathing exercises, mindfulness and cognitive behavioral therapy. cal support, interpretation of data, drafting of the manuscript, critical revision. maji and mg: critical revision. all authors read and approved this manuscript. the authors have no conflict of interest. this article does not contain any studies with human participants or animals. j o u r n a l p r e -p r o o f what to know about 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recently, racial and ethnic disparities within the current coronavirus disease- (covid- ) pandemic at the state level have received attention and notably highlight the ongoing issues surrounding health disparities within the united states. among the discussions around health disparities lies a discussion on the role of psychosocial stress during this pandemic, especially with broadly applied social distancing and isolation recommendations. in nonpandemic times, psychosocial stressors have a significant association with physiological responses and behavioral responses. within the current pandemic, increased attention on health-promoting behaviors, such as cooking and physical activity, has occurred. however, based on disparities from structural racism and socioeconomic effects on neighborhood environments, we may see a limiting value to the possible mitigating role of health behaviors within some disparate communities. we present in this perspective that there may be a role for behavioral interventions to mitigate psychosocial stressors and promote health behaviors. it may also be important to consider the use of multilevel behavioral interventions designed in the context of environmental and perceptual barriers during the coivd- pandemic. early data at the state level show that disparities within the case and mortality rate from coronavirus disease- (covid- ) likely exist and disproportionately affect african americans. although not an infection with a predilection for one racial/ethnic group more than another, disparities in cases of covid- may reflect disparities within the health care and economic systems that can lead to inequity of the effects of covid- . reasons for the disparity in covid- affecting african americans are likely multifactorial, including structural inequities and social injustice, misinformation about infection risk, limited testing availability and health care access, and disproportionate prevalence of preexisting conditions. the downstream effects of the disparity, however, may be long lasting within the african american community beyond when the pandemic subsides and may mirror health consequences of known social determinants of health. african americans are not the only racial/ethnic minority community in the united states that may become disproportionately affected by covid- . however, examining the expected disparity among african americans may shed light on the role of health and socioeconomic inequities as well as identify areas for mitigating the devastating effects of covid- on communities of color. it is important to note that calls for attention to health inequities affecting covid- cases are not limited to the united states as similar concerns have been expressed within china. in addition, racial/ethnic minorities being disproportionately affected by pandemics are not unique to covid- , as during the h n pandemic, hospitalization rates among minority groups were consistently disproportionate. as seen in other pandemics within the past century, the current pandemic covid- can create great psychosocial difficulties for affected individuals. research from prior pandemics has found a wide range of psychosocial impacts, including feelings of helplessness and stigmatization, with negative emotions compounded with the closures of schools and businesses. psychosocial studies from the prior severe acute respiratory syndrome (sars) outbreak between and in china showed disparities in psychosocial effects of that pandemic based on socioeconomic status. , a unique factor that may lead to psychosocial disturbance from this pandemic versus others, such as ebola, is that for covid- , it is difficult and challenging to detect and distinguish the infection from benign conditions. this may place additional psychosocial stress on individuals because social isolating recommendations such as distancing or self-quarantining may be more broadly applied. most pandemics in the past century have received limited study by behavioral scientists. , for those studies that have occurred, attention has rightfully focused on the effect of psychological stressors on preventive or infection-related behaviors. in addition, less attention has been given to the role of health-promoting behaviors during pandemics. in the united states, the biased social construct of race has led to a historical legacy of african americans being the recipients of prejudicial, discriminatory, and racially based exclusionary practices. the ultimate culmination of these practices has led to many african americans having life experiences rooted in racial injustice at individual, structural, and institutional levels. the consequences of these racial injustice experiences may impact and constrain health. experiences with receiving care that is driven by implicit racial biases, explicit use of race in medical decision making, or perceptions of differential health care services have led to significant barriers surrounding trust when it comes to interactions in health care settings. [ ] [ ] [ ] also, repeated exposure to microaggressions, discrimination, and racist practices, especially those of social exclusion, can stimulate physiological stress responses that, when occurring daily, or when occurring in an unpredictable pattern, can be akin to chronic stressors. in addition, discriminatory and exclusionary practices have led to significant racial differences and inequities. predominately, african american communities have fewer economic opportunities, including less home ownership and a disproportionate poverty concentration. consequences of these neighborhood environments can directly impact physical and mental health: less access to foods identified to prevent chronic diseases, increased exposure to violence, , and less access to green space, a known mitigating factor of psychosocial stress. as a result, chronic physiological, psychosocial, and environmental stressors may overburden african americans and, in an inequitable manner, influence poorer health outcomes. furthermore, immune responses to adverse psychosocial and environmental conditions may contribute to an increased risk of covid- morbidity and mortality among african americans. , specifically in relation to covid- , interleukin- (il- ), an inflammatory cytokine associated with chronic stress and with demonstrated racial/ethnic differences, appears to be a key mechanism involved in covid- disease severity. in particular, an association between the sympathetic nervous system hormone adrenaline and il- is found in conditions with increased covid- mortality and underlying chronic diseases disproportionately found among african americans, including cardiovascular disease, diabetes, and hypertension. novel or unique stressors, as may be experienced during a pandemic, can lead to exaggerated sympathetic responses. therefore, there may be a key reason to examine a role for psychosocial factors related to african americans during this pandemic. as already stated, a key consideration within the pandemic is the role of health behaviors and how they impact psychosocial health. health-promoting behaviors, those behaviors actively done by an individual for maintenance or improvement of one's health or to maintain a healthy lifestyle, typically include physical activity, sleep, and dietary behaviors. in nonpandemic situations, psychosocial factors are noted to have a significant association with health-promoting behaviors through physiological (neuroendocrine, cardiovascular, inflammatory, and immune effects) and behavioral responses. [ ] [ ] [ ] hence these behaviors may help to restore some biological and psychological mechanisms negatively affected by psychosocial stress. but engagement in these behaviors may be encouraged or hindered by psychosocial stressors during a pandemic. in fact, a recent web-based survey involving the general population in china found a significant association with anxiety around covid- and sleep disturbances. since the start of the covid- pandemic, two health-promoting behaviors have received specific attention: cooking and physical activity. although there is emerging interest on the role of cooking in psychosocial health, in particular, physical activity may lead to positive effects on lowering il- levels and on immunity and inflammation even in non-covid- viral respiratory infections. examination of reports on these and other covid- -related health behaviors may provide areas of investigation that are key to understanding the impact of this pandemic on health-promoting behaviors. for example, are socioeconomic factors, time availability, or psychosocial factors driving or limiting participation in healthy behaviors during the covid- outbreak? what is the significance of having a history of health-promoting behavior before the covid- pandemic? do motivation and self-efficacy play a role in engagement in the healthy behavior during prolonged social distancing? and are interpersonal psychosocial changes occurring as a result of either starting or increasing the behavior? most importantly, once the covid- social restrictions are lifted, will this health-promoting behavior be maintained or cease, and what are the significant social determinants of such actions? identifying the role of covid- on health behaviors could be especially important for certain populations that are affected by health disparities, such as african americans. as covid- -related social distancing and quarantining conditions may influence involvement in health behaviors, there may be a limit to engaging in these behaviors among these communities due to known social determinants of health, such as type of employment, food access, and perceived or objective neighborhood environment conditions. recognizing the connection of psychosocial experiences to broader social and environmental conditions, in , the who commission on social determinants of health recognized psychosocial factors as social determinants to health outcomes. these factors included social support, social exclusion, and psychological stress. this connection provides a context for understanding the importance of targeting different areas that influence psychosocial health and related health behaviors. we suggest work is urgently needed to not only elucidate mechanisms by which these psychosocial factors may be influenced by other social determinants such as an individual's physical environment, but also to develop interventions that might effectively reduce psychosocial stressors during the covid- pandemic for the most vulnerable populations. for example, mindfulness-based stressreduction interventions are shown to decrease blood pressure readings among low-income african american adults. and intervention studies shown to increase self-compassion and increase social cohesion may lead to decreased il- levels. notably, social cohesion and activities that promote such cohesion, including engaging in church services, are recognized psychosocial coping factors among african americans, , even within the context of psychosocially stressful events. thus, these intervention approaches may allow for the leveraging of existing coping skills and resilience factors in african american communities. the use of sociocultural resilience skills may lead to compounded benefits through reinforcing a positive collective identity. the resultant social capital from this may help to propagate further the use of these skills among individuals. multilevel interventions based on socioecological models including levels for institutional/policy, neighborhood, interpersonal relationships, and individual factors may be especially important to consider. these interventions are uniquely effective at addressing minority health and disparities by providing interventions based on the interconnected levels involved in creating disparities. examples of how multilevel interventions may be useful during this pandemic to address psychosocial health and health-promoting behaviors may include health communication and messaging interventions (institutional and societal levels); promotion and identification of locations within an area to engage in social distancing physical activities (neighborhood levels); family-based interventions around instrumental or emotional support (interpersonal level); and psychological interventions on perception and self-awareness of behaviors (individual level). disciplines involved in these interventions may include health behavior research, positive psychology, and social science. lastly leveraging technology, especially accessibility of smartphone-based platforms, may help to advance the use of multilevel interventions during the current pandemic. in conclusion, to strategically and effectively address health disparity outcomes during the covid- pandemic will require local, state, and federal public health resources with focused health behavior and public health research to address issues related to specific risks among communities of color, specifically african americans. we suggest that deliberate and timely attention to psychosocial health among african americans during the pandemic may also offer opportunities to mitigate expected disproportionate effects of covid- , may help to highlight the role of certain environmental factors on psychosocial health, and may additionally introduce novel health-promoting strategies to individuals, families, and their communities. the statements and contents expressed in this perspective are those of the authors and do not 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disclose. the authors receive intramural funding from the national institutes of health clinical center, national heart, lung, and blood institute and the intramural research program, national institute on minority and health disparities. key: cord- -ik gpxf authors: gonzález-rodríguez, alexandre; labad, javier title: mental health in times of covid: thoughts after the state of alarm() date: - - journal: med clin (engl ed) doi: . /j.medcle. . . sha: doc_id: cord_uid: ik gpxf nan coronavirus disease type of the severe acute respiratory syndrome (sars-cov- ), also known as covid- , was first described in wuhan, china in december and has spread rapidly around the world. as of july , more than million people in the world have been infected by the virus. although some aspects of transmission, infection and treatment are still unknown, the mortality associated with the covid- disease is mainly related to the presence of previous pathologies and expansion in vulnerable populations with chronic lung diseases, immunosuppression, etc. , other factors related to mortality from the covid- disease are age, sex, the appearance of an extreme systemic immune response, bleeding disorders (an increase in d-dimer levels would be associated with an increased risk of mortality) and difficulties in accessing the health system. in view of this, and given the rapid spread of the virus, on march the world health organization (who) decreed a pandemic due to covid- . in spain, one of the countries most affected by the virus, the rapid spread led the government to decree a state of alarm by means of a decree of urgent extraordinary health, economic and social measures (royal decree-law / , of march). the measures taken included isolation, quarantine, social distancing, and confinement. all these measures have proven to be effective in reducing transmission and have been adopted by most countries. we herein reflect on aspects related to mental health during the three months of the state of alarm. first, we will discuss the specific side effects, the adaptation of isolation and the drug treatment in patients with covid- disease. second, we will mention the recommendations or psychological support strategies that are offered to relatives of patients with covid- , and the preventive and psychological support measures for the professionals who care for these patients. lastly, we will address aspects related to the impact on mental health of a stressful situation such as the pan- demic itself or the imposed public health measures, both in patients with previous mental illness and in the general population. in the hospital setting, patients with covid- disease have required isolation and restrictions on transfer and mobility with respect to other patients and professionals. on many occasions it has been necessary to restrict visits from family and friends, thus reducing psychosocial support. in addition to the stress component associated with the isolation or the fear of having a serious infectious disease, the psychopharmacological management of the covid patient with psychopathological symptoms has been a challenge for interconsultation psychiatrists. they have had to care for patients who were being administered medicinal products for the infectious disease that carry the risk of inducing neuropsychiatric symptoms, such as azithromycin, hydroxychloroquine or glucocorticoids, which have been positively linked with psychotic symptoms and mood disorders (depression/mania). the safety of psychopharmacological treatment has been an important aspect to monitor, given the potential interactions that exist between drugs metabolised by cyp a (e.g. hydroxychloroquine), i.e. the risk of qt prolongation when co-administering drugs used for covid- (e.g. azithromycin, hydroxychloroquine) with psychotropic drugs that can lengthen the qt (e.g. antipsychotics or antidepressants). adapting hospitals to the care of covid- patients has had consequences on the mental health of patients. rates of anxiety have increased with restrictions on family visits and uncertainty about the prognosis of the disease. in addition, affective and psychotic symptoms related to the pharmacological treatments of the infection have appeared in some patients which has made the management of these patients more complex. the covid- disease has also been a source of stress for family members, due to the pandemic itself and because some have had to experience bearing the death of a family member. during the state of alarm there have been many cases reported when the family members could not say goodbye to their loved one or carry out the grieving process under normal conditions, with the risk this carries of presenting emotional symptoms that can become chronic in the context of unresolved grief. during these months of health crisis and lockdown, specific care programmes have been put into place for family members whose relatives have suffered - /© elsevier españa, s.l.u. all rights reserved. medcle- ; no. of pages the disease or have died. some general recommendations include the cognitive-behavioral therapy model and strategies to promote interaction with family members. for example, covid- patients admitted to the icu ask about their relatives and seek interaction through conversations and photos. in some cases, audio recordings are recommended, and if end of life is foreseen, a restricted farewell can be organised. another fundamental aspect to take into account in this health crisis is the acute stress generated by situations of high emotional burden and post-traumatic and chronic stress that some groups of professionals who have worked on the front line can develop. in many hospitals, psychological support strategies have been implemented for professionals. in addition, who makes some recommendations for the reduction of stress and psychological anxiety in health professionals, which include the normalisation of emotions, fulfillment of basic needs, social support and a distribution of tasks with flexible working hours. however, individual and group psychological support for these professionals can be helpful in reducing the emotional anxiety and stress they suffer. in a recent study conducted in china that included nurses exposed to covid- , the incidence of post-traumatic stress disorder was . %. post-traumatic stress symptoms were associated with female gender, lower job satisfaction and stress coping strategies (positive relationship with negative coping strategies, inverse relationship with positive coping strategies). as yet, we still do not know the effectiveness of the psychological support measures for professionals in reducing the risk of mental pathology and posttraumatic stress disorder in health professionals. if we focus on the impact of the pandemic and lockdown on the mental health of patients with psychiatric disorders, there are several points to consider. first, the risk and fear of becoming infected by sars-cov- are potentially stressful conditions that modulate the psychopathological characteristics of different psychiatric disorders. given the risk of contagion, the difficulties in controlling the pandemic and the recommendations for hand washing and avoiding physical contact, patients with obsessive-compulsive disorder (ocd) may present a worsening of symptoms, particularly in obsessive ideas of contamination. recent studies suggest a worsening of obsessive-compulsive symptoms in patients with ocd during confinement. other disorders that may have seen an increase in prevalence are substance use disorders, specifically opioid use disorder. during this period, telemedicine visits have also increased in specific addiction units with the aim of reducing the displacement of patients to the outpatient and/or hospital health centers. the covid- crisis may increase the consumption of substances in individual consumption patterns and at home. that is why recommendations have been made to intensify prevention and treatment strategies. also, an escalation in the appearance or exacerbation of behavioral addictions may occur, particularly due to the increase in the use of audiovisual media, such as the so-called «binge-watching». the safety and clinical stability of patients with affective disorders and schizophrenia can also be altered by the pandemic, the state of alarm and the lockdown situation. patients with psychotic disorders may present an increased risk of relapses and hospitalisations, especially those with little awareness of the disease and the need for treatment. recent studies also suggest the existence of brief reactive psychoses triggered by the covid- pandemic. during the covid- pandemic, the use and prescription of long-acting injectable antipsychotics has been one of the great challenges. the restrictions due to the pandemic have made it necessary to modify clinical practice and establish new action protocols. some patients have refused to go to hospitals or mental health outpatient centres for the administration of injectable treatment. in many cases it has been necessary for nursing professionals to visit private homes to administer injectable medication. specific mental health home care programmes have been furthered, which have been considered of special relevance during the current epidemiological crisis. during these three months of state of alarm, outpatient mental health care has had to adapt. face-to-face visits have been reduced and telemedicine strategies have been strengthened, conducting telephone interviews and via videoconference. on certain occasions the face-to-face visits have been maintained, especially in some specific outpatient programmes (administration of injectables, methadone maintenance programme, etc.). in a hospitalisation setting, the protocol of performing the pcr for sars-cov- has been adapted to patients requiring admission to acute units. during the state of alarm, visits by family members and home-visits have been restricted, but little by little there has been a return to normality with the de-escalation phase. electroconvulsive therapy (ect) is another procedure that has required adjustments to be made. when the pandemic was at its peak there was a difficulty to find available anaesthetists, as they were providing care to critically ill patients with covid- . now, when it has been possible to resume activity, security measures have been implemented in the ect protocols, including the intensification of protection measures for healthcare personnel and patients to reduce the risk of infection. even so, the response to mental health services has differed between countries, regions and health areas. in the united kingdom, as in spain, the mental health services and primary care have been flexible in attending to patients, prioritising the most serious cases and intensifying collaborative work. in some countries, such as the united states, accessibility to health services is more difficult because of the state health system. therefore, it remains to know the real impact of the pandemic on the mental health of the general population. it has been hypothesised that there will be a "wave" of mental illness associated with the risk factors of the pandemic: social isolation, loss of employment, economic and housing problems, gender violence, trauma related to work and grief due to loss of family members. future longitudinal studies are necessary to establish the true impact of the pandemic on mental health. a recent study on the impact of the covid- pandemic on the mental health of children and adolescents reported the importance of evaluating anxiety and depressive symptoms in this group. the authors found high rates of depressive symptoms in the chinese population, as well as an increase in behavioral addictions (such as the use of smartphone). in conclusion, the covid- pandemic has forced mental health services and professionals to adapt. some of these changes, such as the development of telepsychiatry or the promotion of mental health prevention in health workers, should be continued over time until they form a part of the department's everyday portfolio. the commitment to home intervention in mental health, with the promotion of home hospitalisation devices and intensive home care, is another positive aspect that should be maintained in the future as an alternative to conventional hospitalisation. it is not known whether there will be another wave in the coming months, and that adds further weight to taking advantage of the changes and the teamwork carried out during the pandemic. in the post-covid period, the early detection of negative consequences for mental health of patients, families, and professionals, as well as the evaluation of the effectiveness of the preventive interventions implemented during the pandemic, is of special importance. it will be an opportunity to strengthen our public health system and mental health research, which has been weakened by the stressful situation suffered throughout these months. dr. gonzález-rodríguez has received fees and/or conference registrations from janssen-cilag, lundbeck-ostuka, and angelini, and dr. labad has been a consultant or has received fees or research funds from janssen-cilag, lundbeck-otsuka and angelini, but these personal relationships are not related to the content of our manuscript. pathophysiology, transmission, diagnosis, and treatment of coronavirus disease (covid- ): a review clinical course and risk factors for mortality of adult inpatients with covid- in wuhan, china: a retrospective cohort study predictors of mortality for patients with covid- pneumonia caused by sars-cov- : a prospective cohort study estimation of covid- prevalence in italy, spain, and france isolation, quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus ( -ncov) outbreak safety of psychotropic medications in people with covid- : evidence review and practical recommendations caring for bereaved family members during the covid- pandemic: before and after the death of a patient umgang mit psychischer belastung bei gesundheitsfachkräften im rahmen der covid- -pandemie factors associated with posttraumatic stress disorder of nurses exposed to corona virus disease in china the impact of the covid- pandemic on patients with ocd: effects of contamination symptoms and remission state before the quarantine in a preliminary naturalistic study innovation during covid- : improving addiction treatment access health behaviour changes during covid- and the potential consequences: a mini-review binge watching behavior during covid pandemic: a cross-sectional, cross-national online survey reactive psychoses in the context of the covid- pandemic: clinical perspectives from a case series long acting injectable antipsychotic medications: ensuring care continuity during the covid- pandemic restrictions the role of mental health home hospitalization care during the covid- pandemic a strategy for management of ect patients during the covid- pandemic what does covid mean for uk mental health care? flattening the curve of mental ill-health: the importance of primary prevention in managing the mental health impacts of covid- an investigation of mental health status of children and adolescents in china during the outbreak of covid- key: cord- - yardtss authors: jephcott, freya l.; wood, james l. n.; cunningham, andrew a. title: facility-based surveillance for emerging infectious diseases; diagnostic practices in rural west african hospital settings: observations from ghana date: - - journal: philos trans r soc lond b biol sci doi: . /rstb. . sha: doc_id: cord_uid: yardtss the aim of this study was to better understand the effectiveness of integrated disease surveillance and response (idsr) facility-based surveillance in detecting newly emerging infectious diseases (eids) in rural west african settings. a six-month ethnographic study was undertaken in in the techiman municipality of the brong-ahafo region of ghana, aimed at documenting the trajectories of febrile illness cases of unknown origin occurring within four rural communities. particular attention was paid to where these trajectories involved the use of formal healthcare facilities and the diagnostic practices that occurred there. seventy-six participants were enrolled in the study, and complete episodes of illness were documented. while participants routinely used hospital treatment when confronted with enduring or severe illness, the diagnostic process within clinical settings meant that an unusual diagnosis, such as an eid, was unlikely to be considered. facility-based surveillance is unlikely to be effective in detecting eids due to a combination of clinical care practices and the time constraints associated with individual episodes of illness, particularly in the resource-limited settings of rural west africa, where febrile illness due to malaria is common and specific diagnostic assays are largely unavailable. the success of the ‘one health' approach to eids in west africa is predicated on characterization of accurately diagnosed disease burdens. to this end, we must address inefficiencies in the dominant approaches to eid surveillance and the weaknesses of health systems in the region generally. this article is part of the themed issue ‘one health for a changing world: zoonoses, ecosystems and human well-being'. emerging infectious diseases (eids) represent a major threat to global health. in recent years, re-emerging and newly emerging wildlife-associated zoonoses such as ebola virus in west africa, severe acute respiratory syndrome (sars), human immunodeficiency virus (hiv) and numerous novel strains of influenza have led to substantial economic and human losses [ ] . prior to constituting a major outbreak, many zoonoses may exist within communities for some time as isolated or small clusters of cases [ , ] . such cases represent an important opportunity for early intervention but often proceed undetected due to a range of poorly defined clinical and social factors, many of which are exacerbated by the remote and tropical environments in which wildlife-associated spillover events tend to occur. west africa has been identified as an environment particularly prone to zoonotic spillover and as such requires special attention for this role in global health [ ] . the recent west african ebola epidemic exemplifies this. the integrated disease surveillance and response (idsr) programme is a centers for disease control and prevention (cdc) and world health organization (who) devised template for domestic infectious disease control infrastructure. in common with much of sub-saharan africa, west african countries rely on the idsr to implement the revised international health regulations (ihr, ) . the revised ihr include mandated surveillance and reporting requirements for 'any event of potential international public health concern, including those of unknown causes or sources' [ ] . previously, the ihr only required cases of three named diseases (cholera, plague and yellow fever) to be reported. substantial changes to reporting and surveillance requirements were triggered by the international spread of sars in , a previously unidentified zoonosis. the idsr primarily relies on facility-based surveillance for the detection of individual or small numbers of cases [ ] . this approach involves a healthcare worker, typically a doctor, identifying a significant disease within their normal professional activities treating patients. as often noted, rare or novel conditions such as an eid are difficult to detect through this approach, especially in a resource-limited clinical setting where there is a high burden of routine infectious diseases. here, we elucidate some of the sociomedical mechanisms that have an impact on facility-based surveillance in an under-resourced rural west african setting. we explore clinical diagnostic processes and their implications for the unseen emergence of novel pathogens. this context places this study of how novel zoonoses may be diagnosed (or not) at the centre of real world one health issues; if diseases are not diagnosed, they will remain neglected. the assumption is often made that important zoonoses can be detected and responded to 'at source', although the lack of reporting of single cases or isolated clusters of important human diseases like ebola is evidence that primary cases that do not spread are almost invariably missed. it is of great concern that current systems must be missing a significant burden of disease. for this study, we set out to explore the effectiveness of facility-based surveillance in rural west africa by undertaking a -month ethnographic study aimed at documenting complete trajectories of cases of cryptic febrile illness arising in the rural community of buoyem in the techiman district of the brong-ahafo region of ghana. buoyem is a rural agricultural community comprising a central town with a population of approximately and a collection of around smaller satellite villages accounting for another inhabitants. the study involved participants recruited from nine households in the buoyem area (table ). of the participants enrolled, came from three households in the main town and from six households taken from peripheral villages selected for their progressive remoteness, as measured by distance to a paved road (an established determinant of formal healthcare utilization) [ ] . enrolled households were visited approximately twice a week for the duration of the fieldwork so that febrile illness episodes could be detected early on and followed in their entirety. during the course of the study, of the enrolled participants developed fevers of unknown origin and were thus incorporated into the research as case studies. the criterion for inclusion as a case study was a self-reported fever of unknown origin occurring within the previous h. fever (a body temperature exceeding . c) is a fairly universal symptom in response to infection. it was reasoned therefore that health-seeking behaviours in response to fever with any combination of other symptoms should provide a good insight into how eids might progress in a remote environment. when a participant self-reported a fever, they were observed throughout the illness episode with particular attention being paid to their health-seeking behaviours and, where the episode involved formal healthcare settings, the processes of nosology. in addition to participant observation in clinical settings, subsequent interviews with the involved healthcare workers and the collection of data from secondary sources, such as patient files and hospital records, took place. sixteen of the recorded illness episodes were deemed 'routine', meaning they were perceived as non-life-threatening and resolved within days with only informal local treatment. this typically comprised the use of licensed pharmaceuticals leftover from previous illness episodes or purchased from a local drug seller, sometimes in combination with a homemade herbal preparation. of the eight participants who had illness episodes that were categorized as 'severe' or 'enduring', meaning they were perceived to be life-threatening or else failed to resolve within days of informal treatment, all used a nearby hospital. three participants belonging to town households attended the town's nurse-run clinic prior to presenting at a hospital (figure ). participants coming from village households tended to shun the clinic, claiming it was too costly relative to the effectiveness of the treatments available there. as all of the cases deemed 'severe' or 'enduring' ultimately ended up presenting to a hospital, shortcomings with facility-based surveillance are therefore likely not a consequence of the health-seeking behaviours of rural populations. rather, if facility-based surveillance is not working, the dysfunction must be within the healthcare setting. as such, our discussion is focused on our observations of the nature and effect of the diagnostic processes within clinical settings. across the eight patients and illness episodes that involved hospital treatment and consultation with a doctor, the observed diagnostic processes were extremely diverse and apparently vulnerable to the interactions of numerous material and human factors. with little or no available literature on the drivers of diagnosis in resource-limited settings, a discussion, even one based on this limited sample, is insightful and important. as expected for any clinical setting, the doctors within the study reported employing a differential diagnostic approach to choosing treatment strategies for their patients. a differential diagnosis is commonly perceived as a systematic and exhaustive process. the three basic steps of a differential diagnosis are examining the patient, compiling a list of candidate conditions and testing candidate conditions in order of perceived likelihood until the underlying condition, or rstb.royalsocietypublishing.org phil. trans. r. soc. b : conditions, has been identified. what follows is a description of the most obvious impediments to accurate diagnosis of a patient presenting to a regional ghanaian hospital with a febrile illness, organized in terms of the three primary steps of differential diagnosis. the following description reveals that, when performed in a resource-limited clinical setting, the diagnostic process is often neither linear nor conclusive. the first step in performing a differential diagnosis involves the physician gathering the relevant information about the patient and their condition. this often involves the taking of a medical history and sometimes a physical examination of the patient. in this study, however, this step was limited to a nurse measuring the patient's temperature, weight and blood pressure and the doctor prompting the patient for a list of their current symptoms. this limited interaction comprised all of the communication during the consultation for all of the eight case studies. all participants remained unaware of their diagnosis and the nature of the drugs that were prescribed, which is consistent with findings from other studies of ghanaian clinical settings [ ] . this lack of communication was associated with poor doctor-patient relationships and perhaps reflected a low doctor-to-patient ratio (about doctors served a population of approximately people in ) [ ] . for seven of the eight cases, this lack of communication-in particular a tendency for patient records to be maintained but not reviewed-led to doctors unknowingly prescribing treatments that had already been prescribed to, and taken by, the patient following earlier visits to formal healthcare facilities, such as the hospital and town clinic. this resulted in therapeutically and diagnostically redundant visits and additional costs to the patient. following the assessment of the patient, the next stage of the differential diagnosis process involves the doctor compiling a list of possible candidate conditions. in theory, these are organized according to likelihood based on the presentation of the patient and the doctor's knowledge of local disease prevalence. in practice, all eight participants who presented to a clinic or hospital with a fever or a reported history of fever were initially diagnosed with, and treated for, malaria. no diagnostic tests, including malaria rapid diagnostic tests (rdts), which were available at some sites, were employed. this practice of presumptive treatment of fever cases for malaria can be linked to a now superseded set of who guidelines on the treatment of malaria in children. however, a growing body of research suggests that it is still commonplace in clinical settings across much of africa [ , ] . as revealed in interviews with the doctors, where antimalarial treatment failed to relieve the symptoms of the patient, the next recourse was the prescription of a broad-spectrum antibiotic. this unofficial treatment protocol was observed in five of the eight case studies. one doctor explained that this was due to the availability of broad-spectrum antibiotics and that it was often a successful strategy. given that a primary role of doctors in this setting is to treat successfully as many patients as possible within severe material and time restraints, the identification of a particular disease aetiology is not always necessary or pursued. the presumptive diagnosis of malaria and subsequent presumptive diagnosis of bacterial infection were both hurdles for the consideration of other candidate conditions. these would not have caused such significant setbacks to the diagnostic process if the testing and discrediting of candidate diagnoses had been done with diagnostic tests and not through the trial and error of different treatments. from the limited number of case studies presented, we cannot establish any patterns of utilization for the diagnostic tests available at the hospitals. there were significant financial disincentives to the use of diagnostic tests, however, both for the hospital and for the patient. patients had to coordinate their own testing, often requiring multiple trips to the hospital at their own expense. uninsured patients were required to pay for diagnostic tests, and the national health insurance scheme (nhis) would provide only limited reimbursement to the hospital for insured patients. the morespecialized tests required to identify any uncommon eid, should a relevant test exist, would be even less accessible and unlikely to be used. it was apparent through the case studies that diagnostic technology is not routinely used when managing a febrile illness, at least not in the early stages. as this resulted in most candidate conditions being tested through the patient's response to various treatments, often only one diagnosis could be considered or discredited at each visit. this had particularly severe repercussions for the rural villagers seeking hospital treatment. the increased associated transport costs the villagers faced and the lower average income and likelihood of nhis membership meant they had to source money communally for their trip and treatment. this typically limited them to no more than two hospital attendances per episode of illness. participants from the town experienced fewer financial restrictions than the villagers and were able to pursue hospital treatment across lengthy courses of illness. they typically only ceased hospital care when failure to resolve the illness led them to doubt the efficacy of the biomedical approach. it was often at this point that a participant would engage a professional traditional healer such as a spiritualist. both the villagers and the townsfolk were largely unaware that many of their hospital visits were redundant. however, these repetitive and often unproductive visits were instrumental in the decision of both groups to not return to the hospital. within the differential diagnosis process, there was no mechanism for feedback to notify the doctor of a successful diagnosis and treatment of a patient. it was therefore impossible to differentiate between a successful and failed diagnosis. correct diagnosis, spontaneous recovery, premature exit resulting from lack of funds or lack of faith in the biomedical approach or death all produced a final untested diagnosis. for example, one of the participants was diagnosed and treated for malaria twice at a hospital in the week prior to his admission as a suspected meningitis case. he died the day following admission. during his admission, a diagnosis of meningitis was rejected and replaced by a tentative diagnosis of hepatic encephalopathy that was not explored. as the illness episode concluded, this diagnosis was recorded as the cause of death without laboratory testing. another factor reducing any consideration of an uncommon diagnosis is the disproportionate representation of diseases perceived to be common locally. in the course of a single episode of illness, multiple disease labels were generated across multiple hospital attendances. for instance, in the case above, the hospital recorded two cases of malaria and one case of hepatic encephalopathy. such a process distorts doctors' perceptions of local epidemiology by skewing disease surveillance data towards already common conditions and further prejudicing them against unusual or less well-established diagnoses. the exact combination of factors that reduced the reliability of the differential diagnosis process varied between cases. in all eight cases, however, confounding factors were sufficient to precipitate an early departure from the process. not one of the eight participants captured in the study ceased to pursue hospital treatment because they had been successfully treated. many of the factors implicated in the consistent failure to diagnose participants are improving across ghana. healthcare and transport infrastructure are improving, there is a decreasing burden of many common infectious diseases and there are interventions aimed at improving doctorpatient relationships [ , ] . many of the recurring problems in identifying early cases of eids are not unique to ghana or west africa. the diagnosis of a rare condition within the time restrictions of a single episode of illness is problematic in any clinical setting. this difficulty is due primarily to the differential diagnosis process being based on a likelihood model and the uncommon (by definition) nature of eids. the processes of identifying and labelling diseases via clinical diagnosis therefore make facility-based surveillance unsuitable as a primary source of eid surveillance. the use of facility-based surveillance for eids within the idsr framework is likely by default rather than by design. the idsr technical guidelines were originally developed to tackle major burdens of infectious disease and, as such, do not include specific instructions for eid surveillance. this results in the task of eid surveillance being absorbed by the system in place for identifying and controlling common infectious diseases. as the idsr is the elected vehicle for the revised ihr ( ) in most of africa, an effective eid surveillance system needs to be developed, especially in environments prone to eids. a more suitable alternative to facility-based surveillance could be the establishment of specialized national diagnostic laboratories that are able to receive and test samples without the patient or local health clinic incurring additional costs or crippling bureaucracy. a number of studies have shown that the existence of a previously unknown pathogen within a human population often does not signal an impending pandemic. indeed, some novel zoonoses have been found to cause only a single case or a small number of cases before apparently disappearing from the population entirely [ ] [ ] [ ] . taking a slower approach to detection, one that exceeds the length of an episode of illness, might be a possible solution. a similar approach is already employed in ghana for influenza surveillance, where regional hospitals act as sentinel sites routinely sending samples to a specialized laboratory to monitor the strains circulating within the country. an archival approach to eid surveillance has utility by slowly contributing to a more nuanced knowledge of the local epidemiology. this characteristic, however, is at the expense of the immediate utility promised by facility-based surveillance in containing the threat of an outbreak, a function it may serve in response to larger and more sudden spillover and outbreak events. as such, the introduction of a laboratory-based system for eid detection should not usurp the place of the facility-based system within the idsr framework but, rather, complement it by providing a more systematic and reliable approach to surveillance. such a reformed system needs to be targeted at regions, such as central and west africa, which are particularly susceptible to zoonotic spillover and therefore likely to see the emergence of a new infectious disease. regardless of the exact approach taken, the creation and incorporation of a dedicated system of eid surveillance into african countries' national disease control infrastructure is imperative. this is not to say that there is not also a need to address the various factors confounding healthcare providers' use of differentials diagnoses in resource-limited settings, which are crucial to the delivery of effective clinical care. however, the success of the one health approach to eids in west africa is predicated on characterization of accurately diagnosed disease burdens. we must attend, therefore, to the inefficiencies in our dominant approaches to eid surveillance in west africa or we will be unable to effectively set public health priorities and prevent future disease outbreaks such as the recent ebola epidemic. ethics. this work was conducted with approval of the noguchi memorial institute for medical research institutional review board ( permit # / - ), the university of cambridge human biology research ethics committee ( permit #hbrec. . ) and the zoological society of london ethics committee (human impacts ref. wle ). the perpetual challenge of infectious diseases epidemic dynamics at the human-animal interface avian influenza a viruses: from zoonosis to pandemic global trends in emerging infectious diseases international health regulations technical guidelines for integrated disease surveillance and response in the african region modelling and understanding primary health care accessibility and utilization in rural south africa: an exploration using a geographical information system perceived quality of healthcare delivery in a rural district of ghana techiman municipal health directorate annual report improved diagnostic testing and malaria treatment practices in zambia guidelines and mindlines: why do clinical staff over-diagnose malaria in tanzania? a qualitative study ministry of health (ghana) the health sector in ghana: facts and figures human viruses: discovery and emergence nosocomial outbreak of novel arenavirus infection b-virus (cercopithecine herpesvirus ) infection in humans and macaques: potential for zoonotic disease competing interests. we have no competing interests. key: cord- - m ch ls authors: ford, james d.; berrang-ford, lea; king, malcolm; furgal, chris title: vulnerability of aboriginal health systems in canada to climate change date: - - journal: glob environ change doi: . /j.gloenvcha. . . sha: doc_id: cord_uid: m ch ls climate change has been identified as potentially the biggest health threat of the st century. canada in general has a well developed public health system and low burden of health which will moderate vulnerability. however, there is significant heterogeneity in health outcomes, and health inequality is particularly pronounced among aboriginal canadians. intervention is needed to prevent, prepare for, and manage climate change effects on aboriginal health but is constrained by a limited understanding of vulnerability and its determinants. despite limited research on climate change and aboriginal health, however, there is a well established literature on aboriginal health outcomes, determinants, and trends in canada; characteristics that will determine vulnerability to climate change. in this paper we systematically review this literature, using a vulnerability framework to identify the broad level factors constraining adaptive capacity and increasing sensitivity to climate change. determinants identified include: poverty, technological capacity constraints, socio-political values and inequality, institutional capacity challenges, and information deficit. the magnitude and nature of these determinants will be distributed unevenly within and between aboriginal populations necessitating place-based and regional level studies to examine how these broad factors will affect vulnerability at lower levels. the study also supports the need for collaboration across all sectors and levels of government, open and meaningful dialogue between policy makers, scientists, health professionals, and aboriginal communities, and capacity building at a local level, to plan for climate change. ultimately, however, efforts to reduce the vulnerability of aboriginal canadians to climate change and intervene to prevent, reduce, and manage climate-sensitive health outcomes, will fail unless the broader determinants of socio-economic and health inequality are addressed. climate change has been identified as potentially the biggest health threat of the st century (costello et al., ) . addressing the challenge will be a defining question for public policy (campbell-lendrum et al., ; costello et al., ; lim et al., ; parry et al., ) . while reducing greenhouse gas emissions responsible for climate change is essential (i.e. mitigation), health systems will have to adapt to climate change through interventions to manage climate-sensitive health outcomes, many of which are now unavoidable ebi and semenza, ; frumkin et al., ; furgal and prowse, ). without such intervention, the burden of climate-sensitive health outcomes will increase confalonierei et al., ) . international assessments have highlighted that developed nations have a high capacity to adapt to the health effects of climate change (confalonierei et al., ; costello et al., ). on the whole, this is true: individuals, communities, and governments have access to significant resources and engage in a range of actions to manage and control climate-sensitive health outcomes (ebi, ; ebi et al., ; watson et al., ) . this assumption, however, does not adequately consider the persistence of withincountry economic and health inequities and their implications for vulnerable populations. this is particularly pertinent for developed nations with indigenous populations living in what has been referred to as the 'fourth world' (o'neill, ) . indigenous peoples in canada, new zealand, united states, and australia all experience a disproportionate burden of morbidity and mortality, with many social, economic, and health indicators similar to those in middleincome nations (cooke et al., ; green et al., ; stephens et al., ) . the existing burden of ill-health increases the sensitivity of indigenous peoples to the adverse impacts of climate change, which combined with a proportionally higher dependence of many indigenous climate change health adaptation vulnerability aboriginal inuit mé tis first nations canada social determinants of health inequality indigenous a b s t r a c t climate change has been identified as potentially the biggest health threat of the st century. canada in general has a well developed public health system and low burden of health which will moderate vulnerability. however, there is significant heterogeneity in health outcomes, and health inequality is particularly pronounced among aboriginal canadians. intervention is needed to prevent, prepare for, and manage climate change effects on aboriginal health but is constrained by a limited understanding of vulnerability and its determinants. despite limited research on climate change and aboriginal health, however, there is a well established literature on aboriginal health outcomes, determinants, and trends in canada; characteristics that will determine vulnerability to climate change. in this paper we systematically review this literature, using a vulnerability framework to identify the broad level factors constraining adaptive capacity and increasing sensitivity to climate change. determinants identified include: poverty, technological capacity constraints, socio-political values and inequality, institutional capacity challenges, and information deficit. the magnitude and nature of these determinants will be distributed unevenly within and between aboriginal populations necessitating place-based and regional level studies to examine how these broad factors will affect vulnerability at lower levels. the study also supports the need for collaboration across all sectors and levels of government, open and meaningful dialogue between policy makers, scientists, health professionals, and aboriginal communities, and capacity building at a local level, to plan for climate change. ultimately, however, efforts to reduce the vulnerability of aboriginal canadians to climate change and intervene to prevent, reduce, and manage climate-sensitive health outcomes, will fail unless the broader determinants of socio-economic and health inequality are addressed. ß elsevier ltd. all rights reserved. livelihoods on the environment, spiritual and cultural ties to the land, demographic trends, and experience of marginalization, makes indigenous peoples particularly vulnerable (furgal, ; furgal and seguin, ; green et al., ) . public health interventions focused on indigenous peoples are needed to prevent, prepare for, and manage climate change risks (i.e. adaptation). assessing vulnerability is essential to this end, locating at-risk populations, identifying vulnerability determinants that need to be addressed, and directing attention to the most appropriate level for intervention (ipcc, b) . canada has been a leader in vulnerability assessment in public health (berrang-ford, ; berrang-ford and noble, ; berrang ford et al., ; charron, charron, , charron et al., ; doyon et al., ; health canada, a,c; ogden et al., ; thomas et al., ) . natural resources canada's from impacts to adaptation: canada in a changing climate , for example, assesses the current state of knowledge on climate change for six regions of canada, and health canada's human health in a changing climate (seguin, ) specifically focuses on climate change and health. however, there remains a significant deficit in information required to inform and guide adaptation among aboriginal peoples-part of what we broadly term an indigenous peoples 'vulnerability deficit.' major canadian assessments of climate change, for example, identify research on aboriginal health a priority for action , and while furgal and prowse ( ) focus on the health of mostly inuit inhabitants in the north, other aboriginal populations have been less studied (healey and meadows, ; wilson and young, ) . this lack of information leaves aboriginal health systems insufficiently prepared to identify the risks of climate change and develop adaptations (seguin, ) . the vulnerability deficit is further evident in the peer-reviewed literature. a review of pubmed ( pubmed ( - , for example, reveals only articles referring to a combination of ''indigenous or aboriginal'' and ''health'' and ''climate change'' and ''canada.'' of this literature, only article formally assesses vulnerability with a focus on the north (furgal and seguin, ) , and only are explicitly concerned with aspects of health in a changing climate. for comparison, articles match the search criteria for canada if ''indigenous or aboriginal'' are excluded. addressing the vulnerability deficit should be a priority for aboriginal health research and planning on climate change (furgal, ; green et al., ; seguin, ) . a common approach to examining health vulnerability begins with the question, 'given projected climate changes, how will this affect health systems?' the long range future is the focus of interest here (often or ), with assessment starting by modeling how health exposures will be affected by climate projections. an alternative approach starts with the question 'what predisposes health systems to be negatively affected by climate change.' the first step here is to characterize the current structure and functioning of health systems, and identify the processes and conditions which affect how health risks are experienced and managed: these characteristics in turn will determine sensitivity and adaptive capacity to climate change (smit and wandel, ) . given that the second approach focuses on current capacity and vulnerability of the health system, we can use existing literature to characterize sensitivity and adaptive capacity to climate changes. this is important given the volume of research on all aspects of aboriginal health: articles using search terms ''indigenous or aboriginal'' and ''health'' and ''canada'' in pubmed ( - ) . in this paper we systematically review the literature on aboriginal health in canada to identify health outcomes, determinants, and trends, and use a vulnerability framework to synthesize how these factors will affect the vulnerability (and resilience) of aboriginal health systems to climate change. on this basis we identify strategic priorities for policy intervention and research needs. aboriginal peoples in canada are constitutionally defined as north american indian (commonly referred to as first nations), mé tis, and inuit (table ). in , aboriginal peoples accounted for % of canada's population, numbering approximately . million, and are the fastest growing segment of the population (table ). in many instances, indicators of economic, social and health well-being among aboriginal canadians compare unfavourably with the canadian population in general (table ) (adelson, ; cooke et al., ; phac, ; stephens et al., ) . aboriginal peoples experience lower life expectancy, higher incidence of chronic diseases (e.g. diabetes), higher rates of infectious diseases (in particular tuberculosis and childhood rsv bronchiolitis), and higher rates of substance abuse, suicide, and addiction, than canadians in general (table ) (adelson, ; banerji et al., ; clark and cameron, ; frohlich et al., ; macdonald et al., ; macmillan et al., ; mcdonald and trenholm, ) . canada's aboriginal population is diverse, including people living on reserves, in the territories, and in rural communitiesthese groups account for approximately half the aboriginal population. we collectively refer to this segment of the population as the 'remote aboriginal population': they are generally remote and rural in character, maintain a close and intimate relationship with the environment, with many still practicing aspects of traditional lifestyles (table and fig. ) (furgal and seguin, ; richmond and ross, ). this remoteness, combined with close links to environmental conditions for livelihoods, creates particular sensitivity to climate change. the remainder of the aboriginal population lives in urban areas, and this population is growing rapidly with migration from remote communities, particularly among young people seeking education and employment (siggner and costa, ; statistics canada, a) . urban aboriginal peoples, in many respects, are engaged in livelihood activities similar to non-aboriginal people and are often disconnected from land based activities. nevertheless, many retain connections with their traditional home (inac, ) . we recognize that focusing on all aboriginal subpopulations risks overgeneralization as there is significant heterogeneity in health outcomes and determinants of health between urban and remote and rural aboriginal populations, and also between and within first nations, inuit, and mé tis. table characteristics of aboriginal habitation. reserves are tracts of land, the legal title to which is held by the crown, set apart for the use and benefit of first nations with constitutional responsibility resting with the federal government. there are approximately reserves in canada. the territories are administrative subdivisions of canada which, unlike provinces, derive their mandate and powers from the federal government. a significant proportion of the population of territories is aboriginal, residing in approximately communities. over half of the aboriginal population lives in urban centres. winnipeg, edmonton, saskatoon, and regina are major urban areas where aboriginal people make up > of the population. aboriginal people also reside in rural settlements outside of the territories and not on reserves, data on this segment of the aboriginal population is lacking. there are, however, shared experiences of health inequalities which result in a unique vulnerability to climate change. the focus in this paper on canada's aboriginal population reflects the serious risks posed by climate change to aboriginal health. canada has already experienced disproportionate warming with climate change, with average temperatures in some northern regions increasing beyond c (acia, ; barber et al., ; ford, a; ipcc, a; prowse et al., b,c) . implications for aboriginal health have already documented, particularly in the arctic (ford, b; ford et al., a; furgal, ; furgal and prowse, ; furgal and seguin, ) . projections of relevance to aboriginal health include: changing temperature and precipitation regimes will increase the probability and severity of extreme events including heatwaves, storms, floods, drought, and wildfire with implications for asthma, chronic respiratory disease, water quality, cardiovascular disease, and the health effects of dislocation and displacement ( fig. ) (charron et al., ; doyon et al., ; hess et al., ; thomas et al., ) . sea level rise and associated coastal erosion are already threatening the viability of some aboriginal settlements . remote aboriginal settlements are particularly sensitive to these impacts, with many dependent on water delivery and sewage collection by truck, basic water treatment facilities, and some settlements located on marginal and hazardous locations, a consequence of government relocation in the s and s (furgal and prowse, ; lemmen et al., ) . warmer, wetter summers have the potential to increase the incidence of water and insect borne disease (e.g. entamoeba histolytica, giardia lamblia, cryptosporidium parvum) (hennessy et al., ; martin et al., ) , while rising temperatures are expected to increase the incidence of temperature-dependant food-borne diseases, including salmonella as well as toxins produced by staphylococcus aureus and clostridium botulinm (hess et al., ; parkinson et al., ) . these are important in an aboriginal context given traditional food cultures, which includes the consumption of raw meats, in which small changes in storage and transport temperatures can significantly increase the risk of food-borne diseases. there will be a number of indirect pathways through which climate change will affect health involving second, third, or even fourth order indirect impacts. these are generally less researched and understood but could be more extensive and disruptive (hess et al., ; mcmichael, ) changing temperatures, for example, are likely to impact the distribution and availability of animal populations important in aboriginal subsistence hunting with implications for community health, nutrition, and well-being ( fig. ) (ford, b; furgal and seguin, ) . climate change could result in increased migration to urban centres as traditional activities and livelihoods are compromised, with implications for disease transmission and diagnosis (parkinson et al., ) . changes to the incidence and prevalence of some infectious diseases will also be indirect, stemming for example from climate impacts in other countries from which diseases may be introduced into canada, or changes in the distribution and densities of vector habitat or animal hosts of zoonotic and vectorborne diseases (berrang-ford, ; berrang ford et al., ). there might also be positive health implications associated with increased economic opportunity with improved transportation in areas currently inaccessible (e.g. by melting sea ice). we structure the literature review using the concept of vulnerability-a concept that underpins much of the research in the human dimensions of climate change (hdcc) field. vulnerability is a measure of the susceptibility to harm in a system in response to a stimulus or stimuli, and can essentially be thought of as the 'capacity to be wounded,' (smit and wandel, ) . in this paper we are interested in aboriginal health systems, defined collectively as organizations, institutions (formal and informal) and resources whose primary purpose is aboriginal health. this includes frontline health personnel, community and territorial health authorities, federal agencies, aboriginal organizations, research bodies, and also individuals and households who are an important informal component of health care provision and advice in many aboriginal communities. the stimulus or stimuli are health risks linked directly or indirectly to climate change. a general model of vulnerability has emerged in climate change scholarship that conceptualizes vulnerability as a function of exposure and sensitivity to climate change and adaptive capacity (ebi et al., ; ipcc, b; smit and wandel, ) . in a health context, exposure refers to the nature of climate-related (direct or indirect) health outcomes. sensitivity concerns the organization and structure of health systems relative to the climate-related health outcomes and determines the pathways through which exposure is manifest. adaptive capacity reflects the ability of health systems to address, plan for, or adapt to adverse climate-related health outcomes and take advantage of new opportunities (ebi and burton, ; ebi et al., ; ebi and semenza, ; ford and smit, ) . exposure, sensitivity, and adaptive capacity are not mutually exclusive, with interaction between these components potentially moderating or exacerbating vulnerability. the recognition of the role of adaptive capacity and sensitivity is important, directing attention to health systems themselves and the nonclimatic factors operating at multiple spatial-temporal scales that determine how climate change will be experienced and responded to (ebi and burton, ; ebi et al., ; ford and smit, ; ford et al., b ). this general model of vulnerability has been applied essentially in two main ways in vulnerability research (burton et al., ; o'brien et al., ; ford et al., b) . firstly, 'end point' approaches begin by projecting climate change impacts and then estimate potential vulnerabilities to future conditions, and have historically dominated the hdcc literature in general. the first step towards tackling the vulnerability deficit for aboriginal health using this approach would be to develop climate scenarios to model changing exposure. this is a time consuming and intensive process, however, and is particularly problematic in a canadian aboriginal context where baseline data that is needed for health modelling is lacking . more generally, 'end point' assessments have been criticized for neglecting the complex dynamics that shape how climate change is experienced and responded to, focus on future conditions and risks as opposed to current stresses that are relevant to the people being affected, neglect of indirect health risks that cannot easily be modeled, and failure to capture the dynamic nature of vulnerability (brooks et al., ; ford and smit, ; o'brien et al., o'brien et al., , smit and wandel, ) . conversely, 'starting point' approaches begin with the system of interest, examining the factors that determine sensitivity and adaptive capacity to climate related risks and change (burton et al., ; o'brien et al., ) . common in the hdcc literature in general (adger, ; burton et al., ; o'brien et al., ; smit and wandel, ) and increasingly in a health context (ebi and burton, ; ebi et al., ; ebi and semenza, ; furgal and seguin, ) , vulnerability here is viewed as a state or condition, not an outcome, continually evolving and changing. the 'starting point' approach seeks, therefore, not to identify vulnerability independently attributable to climate change, but to understand the conditions and processes that predispose a system to negative effects. in the context of the vulnerability deficit this approach directs attention to aboriginal health systems themselves, a topic which has been the focus of significant research. recurring themes in this literature concern the social, economic, political conditions that affect aboriginal health outcomes. this work has renewed importance for understanding climate change vulnerability, and we use a 'staring point' approach to identify and examine the broad characteristics of aboriginal health systems that influence their sensitivity and adaptive capacity. we used keyword combinations to search for peer reviewed articles on aboriginal health published from to july using pubmed database. keywords used included: ''aboriginal '' or ''indigenous'' or ''first nations'' or ''inuit'' or ''health problems,'' and ''social determinants of health.'' information was also obtained from other sources, including aboriginal organization websites, government reports about the status and health of aboriginal peoples and health of canadians in general. our search was limited to publications in english. once all relevant sources were identified and retrieved, pertinent information on aboriginal health outcomes, determinants, and trends, was extracted, categorized, and analyzed using the vulnerability framework described above. in this section we examine the broad characteristics of aboriginal health systems that will determine vulnerability to climate change. these determinants do not exist in isolation and fig. captures important interactions and highlights how these broad scale or underlying factors provide the context within which local to regional health systems will experience and respond to [ ( f i g . _ ) t d $ f i g ] table provides an overview of the determinants of vulnerability. canada is a wealthy nation consistently placed near the top of the united nations develop programs human development index, and as such is expected to be less vulnerable to climate change (cooke et al., ; o'brien et al., ) . national level indicators, however, hide significant disparities, with aboriginal peoples at substantively higher risk of living in poverty and experiencing housing and food insecurity (adelson, ; mcdonald and trenholm, ; phac, ; raphael et al., ) . these gaps continue to grow despite policy intervention, and are particularly pronounced among the remote aboriginal population (table ) . a complex interplay of factors has been identified to contribute towards high rates of poverty including low labour force participation, lack of employment opportunities, low educational attainment, loss of land and sovereignty, high cost of living in remote areas, job market discrimination, and the burden of illhealth (rcap, ; adelson, ; phac, ) . poverty influences climate vulnerability at two main levels: individual/household level and institutional level. firstly, at an individual and household level, poverty translates to negative health outcomes through material conditions and associated behavioural factors (frohlich et al., ; woolf, ) increasing the sensitivity of aboriginal canadians to climate risks. poverty forces many to live in suboptimal conditions, engage in dangerous livelihood activities, live in areas at high risk, and increases the risk of engaging in unhealthy behaviours (e.g smoking, drinking). overcrowding in inadequate housing and food and water insecurity, for example, are chronic poverty-related problems facing aboriginal people across canada (boult, ; dunn et al., ; egeland et al., ; ford and berrang-ford, ; hamelin et al., hamelin et al., , harvey, , ; shaw, ) . those who are nutritionally challenged will be particularly vulnerable to changing access, availability, and quality of traditional foods with climate change, and susceptible to increasing incidence of climate-sensitive infectious diseases (ford, b; furgal and seguin, ) . similarly, house overcrowding and high rates of tobacco use increase the risk of person-to-person spread of infectious diseases, favor transmission of respiratory and gastrointestinal diseases, and increase susceptibly to heat stress; health outcomes with a strong link to climate and expected to increase in prevalence with warming temperatures and changing precipitation regimes (furgal and seguin, ; orr et al., ; parkinson et al., ) . the sensitivity of aboriginal canadians will result in health impacts of climate change occurring faster, sooner, and of a greater magnitude than for non-aboriginal people. this will challenge the ability of health systems to adequately invest time and resources in prevention, preparedness, and response seguin, ) . adaptive capacity at an individual and household level is also negatively affected by poverty, with many adaptations exceeding financial means. poverty has already been noted as a major constraint to adaptation to climate change related disruptions to subsistence hunting and fishing in arctic regions with implications for food security (furgal, ; furgal and seguin, ; turner and clifton, ; wolfe et al., ) . a number of behavioral and psychological conditions associated with poverty including substance abuse, addiction, stress, family disruption, alienation, and compromised education are also strongly associated with limited capacity to identify and respond to risks phac, ; tanner and mithcell, ) . research has identified how social networks which increase uptake of adaptive measures and are essential to well-being and managing climate change can be undermined by addictive behaviour (chan et al., ; beaumier and ford, in press; ford et al., a; pearce et al., ). notwithstanding, a critical factor in moderating the effects of climate change on aboriginal health lies in the adaptability and the resilience of aboriginal peoples (ford, a; ford and furgal, ; furgal, ; furgal and seguin, ) . aboriginal peoples have a deep attachment to their lands and their cultures, and this forms part of identity, which is a determinant of health . however, aboriginal cultures and identity are not static or fixed in time. aboriginal peoples are adaptable if they are allowed to, and current rates of poverty, and associated health impacts challenge this capacity. secondly, poverty is a major constraint on institutional capacity to respond to climate change. institutions with jurisdiction over reserve and territory-based aboriginal populations are challenged by human and financial resources, and exacerbated by the challenge of poverty (adelson, ; . substantial shortfalls remain in meeting basic needs, and planning for future health problems frequently ranks behind other existing challenges (mathias et al., ) . even in nunavut, which is globally believed to be a climate change 'hot spot' and where awareness of climate change is high, health systems at a local and territorial level have not had the financial or human resources to assess or plan for climate change health impacts; poverty related issues are more pressing (boyle and dowlatabadi, in press; ford et al., ) . to compound these difficulties, it has also been argued by some policy makers that resources and attention directed to climate change should be invested in poverty alleviation, with climate change perceived as a distant, diffuse, and uncertain threat (mathias et al., ) . this is ill-advised on a number of levels yet is challenging institutional response to climate change. firstly, climate change has the potential to exacerbate poverty, further increasing health vulnerability to climate change. secondly, climate change projections for canada in the ipcc (ipcc, c) and lemmen et al. ( ) are now widely believed to be conservative, with significantly greater impacts projected (barber et al., ; schellnhuber, ) . finally, addressing climate change and poverty need not be a zero sum game: climate policy has significant potential for co-benefits and can be mainstreamed into ongoing health activities and planning (campbell-ledrum and woodruff, ; ebi and burton, ; ebi and semenza, ; patz et al., ) . ameliorating poverty is a key challenge to improving aboriginal health, reducing vulnerability to the health effects of climate change, and creating an enabling environment for adaptation. as long as aboriginal people experience a higher prevalence of poverty than canadians in general they will bear a disproportionate vulnerability to climate change. reversing the current state of poverty is a significant undertaking requiring long term strategic investments in sustainable economic development, education, infrastructure, health care, the settlement of outstanding land claims, and greater involvement of aboriginal communities and organizations in decision making (rcap, ) . there is evidence that the cycle of poverty is being broken in some communities and regions, offering hope for the future. the assembly of first nations, for example, has recently launched a strategic plan to decrease poverty through creating opportunities, building on community assets and structural change for management of resources (assembly of first nations (afn), ) while the northern territories are trying to harness resource development to provide a basis for creating new and lasting economic opportunities. technological capacity refers to the ability of health systems to identify, respond to, and manage health risks, including those associated with climate change, through the application of appropriate technical strategies or interventions in the areas of diagnosis, treatment, surveillance, early warning, and planning. the canadian health system generally has a high technological capacity: geographical information systems are widely utilized to project future health burden and optimize planning, advanced treatments and preventive care are universally available, a strong educational and scientific base underpins a vigorous health research sector, and effective surveillance and early warning systems are in development or operation (davidson, ; gosselin et al., ) . this capacity reduces vulnerability to climate change and provides a strong basis for adaptive planning ipcc, b; phac, ) . aboriginal canadians enjoy many of the health benefits of the technologically sophisticated canadian health system. diagnosis and treatments, for example, are provided to aboriginal peoples through canada's universal and comprehensive health care system (madore, ) . however, technological capacity to address health outcomes for aboriginal peoples and plan for future risks is constrained by the accessibility of health services and availability of technology to health systems, contributing to unequal health burden (romanow, ) . this increases the sensitivity of aboriginal health systems to climate-related health outcomes and compromises adaptive capacity. firstly, canada's remote aboriginal population frequently note barriers to accessing health services, ranging from wait times, a shortage of doctors/nurses in the area, limited access to specialty and emergency services, the cost of transportation to health centres, to complaints that services provided are inadequate or not culturally sensitive (mackinnon, ; minore et al., b; muttitt et al., ; nti, ; wardman et al., ) . this is partly a function of geography. servicing small communities located in remote regions, many only accessible by air, is difficult and poses significant strain on health budgets. frontline health care in communities therefore often only involves basic diagnostic and treatment services, with other services provided in regional centres which may require significant travel and associated family disruption and financial stress (anderson et al., ; muttitt et al., ; wardman et al., ) . challenges of geography are compounded by the cross-cultural context of health provision. in particular, high turn-over of frontline health personnel, lack of training on working in aboriginal contexts for health professionals, language, and history of oppression through the medical system, have been noted to create reluctance among aboriginal people to seek health advice (adelson, ; bird et al., ; minore et al., b; tester and irniq, ) . urban aboriginal populations generally face fewer problems with health care services widely available. physical availability of services however, does not ensure health services are accessed or considered accessible; in many ways challenges associated with cultural sensitivity are more pronounced among urban aboriginal populations as they leave community health networks to the anonymity of urban health systems (adelson, ) . improving access and reducing inequalities to health services is a major challenge and has significant importance for climate change vulnerability. preventing, reducing, and managing the health burden of climate change requires individuals having access to timely and effective information, diagnosis, and treatment (berrang-ford, ; kovats and haines, ) . while some barriers to health service access reflect the reality of living in remote areas and others will only be overcome over time (e.g. trust in health system), some of the more egregious determinants can be addressed. entry points suggested in the literature include: collaboration between aboriginal stakeholders, policy makers, and frontline health workers to improve cultural sensitivity, training of health practitioners in both traditional and western health systems, and improved use of multi-media technology to communicate health messages (abonyi and jeffery, ; minore et al., b; muttitt et al., ; . secondly, effective surveillance and early warning systems are critical components of efforts to anticipate and respond to the effects of climate change and other risks on health (ebi and semenza, ; harrell and baker, ; parkinson et al., ) . surveillance involves the systematic collection of information on health determinants and outcomes necessary to determine the occurrence and spread of health risks, identify the emergence of new risks, and disseminate information to relevant actors. early warning systems provide timely information to populations and frontline health personnel when a threat is expected. current surveillance and early warning capacity for canada's remote aboriginal population, is underdeveloped (furgal, ; furgal and prowse, ; parkinson et al., ) . the fundamental challenge, as note, is the inadequacy of health data for planning: data sources that do exist are often inconsistent, sometimes based on faulty calculation methods, and are of limited coverage, baseline data do not exist for some health conditions and universally accepted measures, collection methods and techniques vary over time limiting the possibility for longitudinal analyses, surveillance among small populations limits analytical capacity for identifying significant changes and thresholds, and culturally and locally specific indicators have not been developed. these problems are compounded by challenges to institutional memory and high staff turnover in aboriginal health systems noted in sections . and . . early warning and surveillance capacity in canada's urban centres is generally more advanced, and information on a range of emerging health risks is available to urban aboriginal populations as part of broader health initiatives. nevertheless, problems surrounding culturally specific communication, surveillance of aboriginal-specific health sensitivities, and lack of baseline data on health outcomes, have also been noted in urban contexts (health canada, b; tudiver et al., ) . for remote aboriginal populations, existing surveillance is insufficient to detect the occurrence and spread of climate change related health risks, and early warning systems are insufficient to deliver projections in a timely and effective manner (kondro, ; , increasing sensitivity and reducing adaptive capacity to climate-related risks negative health outcomes. investments are needed to increase surveillance and early warning capacity, including the identification and monitoring of culturally specific and locally relevant health indicators in a systematic manner, examination of the potential to use sentinal health events as indicators, identification of indicators to monitor emerging climate change impacts and vulnerabilities, and development of infrastructure to link indicators to early warning (eyles and furgal, ; furgal and gosselin, ) . several aboriginal groups have initiated projects to develop indicators for surveillance, including climate change indicators, and offer insights for the development of national level systems (abonyi and jeffrey, ) . researchers have also started to work with communities to develop innovative surveillance approaches (martin et al., ; tremblay et al., ) . continuation and expansion of these initiatives requires addi-tional financial and human resource commitments at all levels of government. climate change will result in the emergence of health risks which cross borders, extend over multiple spatial-temporal scales, and span jurisdictions of government departments (campbell-lendrum and woodruff, ) . addressing these risks will require new governance structures, including increased participation of vulnerable peoples in decision making, increased accountability, and financial commitments (costello et al., ) . aboriginal canadians, however, face unique political challenges to achieving a range of social, economic, environmental, and health goals, with implications for sensitivity and adaptive capacity to climate change effects on health. as damman et al. ( ) note, government policies and actions often do not sufficiently address aboriginal interests, culture and lifestyle, specifically socioeconomic and spiritual connections to the land. inequality is evident in the neglect of aboriginal rights which are -in theoryprotected by the canadian constitution and international human rights obligations of the canadian state (damman et al., ; nilsson, ; raphael et al., ) . overcrowded living conditions, food and water insecurity, discrimination, and outstanding land claims are a few examples of this neglect, earning canada rebukes from the united nations (inac, ; statistics canada, b; united nations human rights council, ). marginalization of aboriginal peoples has been compounded by refusal of the canadian government to ratify international treaties which establish obligations for states towards indigenous peoples including the un declaration on the rights of indigenous peoples (un, ) , and domestic initiatives including the kelowna accord which aimed to substantively invest in programs to address aboriginal inequality (government of canada, november - , ; patterson, ) . political inequality links to climate change vulnerability in a number of ways. firstly, political inequality has been linked to a range of negative social, economic and health outcomes which increase sensitivity to climate-related health outcomes (adelson, ; richmond and ross, ). secondly, concerning adaptive capacity, inequality reduces the political power of aboriginal peoples to draw attention to pressing issues and develop interventions to manage emerging threats including climate change. this is evident in the reluctance of successive federal governments to advocate aboriginal rights on an international stage and develop effective policy domestically, for example with regards food and water security, and health inequality (budreau and mcbean, ) . this is also evident with climate policy. canada has made limited progress towards meeting its ratified commitments under the un framework convention on climate change (fccc), specifically its mitigation commitments to ''stabili [ze] greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system,'' (fccc, ) ; indeed emissions have rapidly increased since the signing of kyoto (weaver, ) . the fact that this commitment is unmet has particular relevance for aboriginal canadians who's livelihoods are sensitive to climate change, particularly in arctic regions where a strong climate change signal has already been detected (cbc, ; prowse and furgal, ; prowse et al., a) . the canadian state nevertheless has obligations to aboriginal peoples through the constitution and human rights treaties. while these obligations have often been overlooked, increasing public sympathy with aboriginal issues, visibility of inequality, and increasing political power of aboriginal peoples as reflected in self government for some regions, provides a basis for renewed political lobbying. the recent apology by the federal government to aboriginal canadians for past abuses of the state also potentially signals willingness for a new era of cooperation. this will be important with climate change which has the potential to compromise the basic human rights of many aboriginal peoples in absence of intervention, particularly in remote and northern regions (crump, ; ford, a; lukovich and mcbean, ). open and meaningful dialogue will be essential to ensure that policies respect, protect and fulfill the rights of aboriginal peoples. federal departments (e.g. health canada, indian and northern affairs canada, public health agency) are also working with aboriginal communities in vulnerable, mostly arctic, regions to develop programs and measures to facilitate adaptation. aboriginal canadians are also uniquely sensitive to climate change deriving from the cultural and spiritual relationship to ''the land.'' the ability to engage in traditional activities (e.g. hunting and fishing) and environmental stewardship remain central to aboriginal identify and culture and are closely linked to health, even for many urban aboriginal populations who no longer live on traditional lands or regularly engage in traditional activities. climate change threatens this: changing ice regimes are limiting access and availability of culturally and nutritionally important animal species, warming temperatures are increasing incidence of abnormalities and certain diseases in animals with implication for meat consumption, coastal erosion is threatening important cultural sites, and changing weather and wind patterns are challenging traditional environmental knowledge lemmen et al., ) . policy intervention can help manage some of these changes but some predicted impacts will result in irreplaceable cultural loss. in arctic regions, for example, climate change will make some communities uninhabitable and necessitate relocation, in other instances changing access to traditional areas and loss of livelihood may precipitate increased migration away from aboriginal communities (parkinson and berner, ). relocation could lead to an exacerbation of loss of culture and disconnection from the land, with implications for depression, anxiety, and substance abuse (berry et al., ; hess et al., ; kvernmo and heyerdahl, ) . these socio-cultural impacts present limits to adaptive capacity, where a limit implies an absolute barrier to adapting (adger et al., ) and indicates the continued importance of mitigation. health systems are composed of multiple institutions, including government health departments at municipal to federal levels, frontline health provision, research institutions, international donors, and informal community wellness groups. high income countries including canada are generally believed to have well developed institutional capacity underpinning the ability to identify, recognize, evaluate, anticipate and respond to health risks and learn from past mistakes. recent experiences in canada and developed nations more generally, however, including severe acute respiratory syndrome (sars), h n , and hurricane katrina, have challenged this complacency (ebi, ; ebi and semenza, ) . the institutional capacity of aboriginal health systems in remote areas is a particular concern, and is constrained by two key challenges: jurisdictional conflict over health care provision and human and financial resource limits. firstly, health care provision in canada for first nations and inuit falls under two jurisdictions, federal and provincial. all canadians are entitled to comprehensive, accessible, portable and universal health care as stated in the canada health act, , with provinces responsible for providing and financing the majority of health care services. however, provincial jurisdiction on health care in most instances does not extend to reserves which, along with the territories, fall directly under the jurisdiction of the federal government. through the first nations and inuit health branch, the federal government is mandated to provide a range of services to aboriginal people not covered by provincial jurisdiction, including primary health care and mental health (madore, ) . more recently, health transfer initiatives have sought to empower aboriginal communities and regions directly to manage their own health care with varying degrees of success. many services remain federally directed however. while in theory this model should cover aboriginal health needs, the reality is often much different. as documented in the literature, jurisdictional responsibility is not always clear and in some instances is shared, the status of health as a treaty right has not been settled with implications for local level health provision, decision making is often fragmented, and disputes within and between federal and provincial agencies regarding a range of health services for which there are pressing needs impedes health care access (adelson, ; mackinnon, ; minore et al., b) . urban aboriginal populations receive health care through provincial health care systems and do not generally face the same jurisdictional challenges. the consequences of this jurisdictional predicament are fragmented delivery of health care for aboriginal peoples on reserves and in the territories, uncoordinated management, constrained and short-term policy development, and a bureaucratic maze that constrains health provision and compromises health kirby, ; romanow, ) . these problems have implications for climate change vulnerability. indirectly, institutional constraints increase sensitivity and reduce adaptive capacity to climate change and act as a barrier to adaptation by limiting access to health services, constraining technology transfer and development, and posing barriers to developing baseline information on health vulnerabilities. directly, institutions characterized by jurisdictional conflicts, limited accountability, and complex bureaucracy are less likely to be able to identify, prepare for, and manage emerging risks like climate change, and learn from past mistakes (adger, ; berkes et al., ; gunderson and holling, ; keskitalo and kulyasova, ) . secondly, institutional capacity, particularly in remote areas, is constrained by human and financial resources. this has direct implications for sensitivity and adaptive capacity to climate change because local capacity is important for identifying and managing risks: evidence from multiple contexts has shown that well developed local health capacity increases the likelihood that policies and actions will be appropriate, effective and acceptable (blas et al., ; ford et al., ) . difficulty in recruiting and retaining human health resources has been widely noted (bird, ; boyle and dowlatabadi, in press; marrone, ; minore et al., a) . high staff turnover presents barriers to developing relationships with community members and stakeholders and creates problems for basic service delivery with employees often overworked and fatigued, key positions vacant, and inexperienced personnel undertaking responsibilities for which they do not have the necessary training or expertise. in this context, action on climate change is often undermined by other priorities, dependant on personnel, and subject to sudden change. if the health of aboriginal peoples is to be improved, sensitivity to climate change reduced and adaptive capacity enhanced, there is a need to build health systems that work well, provide universal care, ensure enough staff, and provide adequate health education (adelson, ) . policy discussion has focused on numerous ways to address institutional problems including resolving aboriginal land claims, consolidating fragmented funding, adapting health programs to local priorities, giving aboriginal people a direct voice in health planning, making aboriginal health the responsibility of provincial and territorial governments, and increasing self reliance (mackinnon, ; phac, ; richards, ; romanow, ) . as romanow ( ) reports, this will require a new structured approach that cuts across jurisdictional barriers and develops a new ethos of coordination and cooperation among government levels. the inadequacy of attempts to address the institutional determinants of poor health that have been widely recognized since the s is discouraging. however, increased self government, self determination, community level health initiatives, and the recent apology to aboriginal peoples by the federal government provide a strong basis from which to build. as fankhuaser and tol ( ) argue, ''successful adaptation requires a recognition of the necessity to adapt, knowledge about available options, the capacity to assess them, and the ability to implement most suitable ones.'' without this information, health systems are less likely to develop anticipatory adaptation interventions, leaving them sensitive to climate change risks and constraining adaptive capacity. vulnerability assessment is an important first step for providing the necessary information for adaptation. as noted in the introduction, however, information on aboriginal health system vulnerability is limited. this paper goes some way towards addressing this deficit, developing an understanding of the broad level or underlying determinants of vulnerability (fig. ) . this needs to be complimented by in-depth vulnerability assessments at local to regional scales to examine how broader determinants interact and shape local level factors, and specifically identify high risk regions and groups, characterize sensitivity to important health outcomes, evaluate current health planning in light of current impacts and future projections, and assess and prioritize response options (fig. ) . such initiatives require close collaboration with aboriginal communities, organizations, and policy makers, integrating local expertise, knowledge, and understanding of health determinants (adelson, ; green et al., ; pearce et al., pearce et al., , raphael et al., ; richmond and ross, ) . there is also need for a comprehensive assessment of the various pathways through which climate change will affect the incidence and prevalence of various outcomes affecting aboriginal health systems, many of which will be unique influenced by livelihoods, living conditions, and traditional food cultures. uncertainly about climate change impacts on aboriginal health characterises much current scientific understanding, and is magnified at regional and local levels where risks are largely unknown among policy makers and communities. this constrains effective risk assessment and planning. improved scientific understanding needs to be complimented by more effective partnerships with aboriginal communities and organizations and culturally relevant knowledge translation. the significant body of literature on aboriginal health provides considerable insights on the broad level determinants of vulnerability which will shape the extent to which aboriginal health systems are able to prevent, prepare for, and manage the effects of climate change. a number of key trends are highlighted in the review: material conditions and behaviours associated with poverty will increase sensitivity and constrain adaptive capacity to climate change. surveillance and early warning capacity for those living in remote regions is underdeveloped for identifying emerging risks and vulnerable populations. comprehensive, reliable, and culturally specific health assessment measures from which to assess climate change impacts are absent. access to health information, diagnosis, and treatment is insufficient for timely and effective intervention to manage climate-sensitive health outcomes. the special rights and needs of aboriginal peoples have often been neglected, resulting in continued and persistent inequality which exacerbates climate change health vulnerability. institutions responsible for aboriginal health are challenged by jurisdictional conflict and resource constraints, limiting the ability to identify and prepare for future risks and address inequalities. these underlying determinants provide the context within which health system vulnerability at regional to local levels will be influenced. how they influence vulnerability at lower scales, however, will not be uniform. inuit will probably experience the greatest vulnerability to climate change on account of the sensitivity of arctic environments to climate change, magnitude of projected changes, remoteness of communities, dependence on the environment, burden of poor health, and limited institutional capacity (furgal and prowse, ; furgal and prowse, ). however, the settlement of outstanding land claims with inuit could provide the basis for progress in addressing inequalities that lie at the heart of many health problems (tester and irniq, ) . the challenges facing first nations and mé tis will be similarly diverse, reflecting colonial history, extent of environmental dispossession, existence of outstanding land claims, and local institutional capacity and accountability. geography also matters. aboriginal peoples living in remote areas generally face more challenges and enhanced climate vulnerability than urban populations on account of their remoteness, close links to the land, and more pronounced socio-economic-political marginalization. access to informal health networks (e.g. through family, community wellness initiatives), however, remain strong in remote settlements and more is known about the burden of ill health among remote aboriginal populations than urban-based populations (adelson, ; wilson and young, ) . the factors that are identified here as creating aboriginal health system vulnerability in canada are also evident among indigenous populations in other 'fourth world' contexts. similarly, many adaptation challenges noted here are comparable to those documented by other studies in mostly middle-and some lowincome nations, challenging the generalization that developed nations have a high capacity to adapt to climate change. yet despite this, there are few examples of systematic attempts to assess the vulnerability of indigenous peoples, identify adaptation needs, or initiate adaptation action. as has been argued in the general climate change and health literature, a new public health movement is required to promote adaptation to the health effects of climate change (costello et al., ) . for indigenous peoples in developed nations this movement needs: interdisciplinary scientific research to characterize climate vulnerabilities specifically at local and regional levels and identify and prioritize opportunities for adaptation. health sector leadership to integrate climate change into health planning and provide guidance on the risks of climate change and importance of adaptation. effective communication from 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research in the social sciences: current trends and future directions from isotopes to tk interviews: towards interdisciplinary research in fort resolution and the slave river delta, northwest territories future health consequences of the current decline in us household income this project was supported by the social sciences and humanities research council of canada, the canadian institutes of health research, arcticnet, and the international polar year caviar project. two anonymous reviewers provided detailed and constrcutive feedback. thanks to adam bonnycastle for figures and . key: cord- -burm nxm authors: eckmanns, tim; füller, henning; roberts, stephen l. title: digital epidemiology and global health security; an interdisciplinary conversation date: - - journal: life sci soc policy doi: . /s - - - sha: doc_id: cord_uid: burm nxm contemporary infectious disease surveillance systems aim to employ the speed and scope of big data in an attempt to provide global health security. both shifts - the perception of health problems through the framework of global health security and the corresponding technological approaches – imply epistemological changes, methodological ambivalences as well as manifold societal effects. bringing current findings from social sciences and public health praxis into a dialogue, this conversation style contribution points out several broader implications of changing disease surveillance. the conversation covers epidemiological issues such as the shift from expert knowledge to algorithmic knowledge, the securitization of global health, and the construction of new kinds of threats. those developments are detailed and discussed in their impacts for health provision in a broader sense. the term digital epidemiology is in this special compilation defined by marcel salathe as epidemiology that uses data that was generated outside the public health system, i.e. with data that was not generated with the primary purpose of doing epidemiology (salathe ) . arguably a narrow definition, we will use this conceptualization as the starting point for our conversation. the so defined digital epidemiology promises faster detection of disease outbreaks and improved surveillance as well as reduction in administrative and financial burden, among other things. at hand in the following conversation is less the question if those promises are kept. instead we are interested to reflect epistemological/methodological, ethical/legal, social/political, and organizational aspects and implications corresponding to the promise of digital epidemiology. what will be the relationship of traditional and digital epidemiology? will a possible change influence the scope of public health and global health? tim eckmanns, henning füller and stephen roberts discuss political implications of digital epidemiology. digital infectious disease early detection systems such as the promed-mail, global public health intelligence network (gphin), healthmap, the now closed google flu trends or the syndromic surveillance system essence are central elements of global public health surveillance. however, with increasingly digitalized (algorithmic) global public health surveillance systems and related data-driven epidemiological analyses (e.g., digital epidemiology and other research methodologies), there seem to emerge epistemological shifts, as well as methodological ambivalences and diverse social and political effects. you, henning and stephen, both work from a social (or rather political) science perspective on the societal implications of digital epidemiology, which is shaped by multiple imperatives, e.g., of 'global health security' as well the potentials of big data. over the past two decades, i would argue, we have seen an unleashing of the algorithm across practices of health security and surveillance. algorithmically-guided infectious disease surveillance systems have proliferated across global health geographies, seemingly in response to a series of interconnected and complex transformations within global health governance (ghg), as well as the practice of international relations and international security. we have seen the rise of a seeming 'epidemic of epidemics' from the late twentieth century onward, including the emergence of hiv-aids, novel strains of avian and swine influenza, sars, ebola, mers, the zika virus, and the re-emergence of cholera, polio and multi-drug resistant tuberculosis across low and middle income countries (lmics) clinical and public health surveillance practices with their routinised processes of data collection, analysis, and dissemination from national health institutes have increasingly fallen out of pace with the capacity to timely identify the globalised spread of novel and re-emergent pathogens. correspondingly, the rise of the digital era, resultant from technological interconnectivity and innovation, has generated infinite, voluminous and diverse data at a rate never feasible in history. between and , . quintillion bytes of data have been produced continually, every day in the mere span months (ibm ). celebrated for the capacity to connect the operational 'dots' between these seemingly unintelligible and largely unstructured streams of data in the surveillance and identification of infectious disease outbreaks, the algorithm has emerged as salient and novel technology of security in the pre-emption of pandemic threats in the twenty-first century. to firstly illustrate this shift, in late november , the global public health intelligence network (gphin), a semi-automated online health surveillance system, which piloted the use of retrieval algorithms to filter international media sources, identified the early reporting of a form of atypical pneumonia circulating in guangdong province, china. the 'algorithmic gaze' of gphin identified the origins of the severe acute respiratory syndrome (sars) in advance of months of traditional public health and governance authorities. more than a decade following the rapid spread of sars, healthmap, an online health surveillance system, identified again, via algorithmic processing of digital data streams, the emergence of a mysterious hemorrhagic fever occurring in macenta, guinea. healthmap critically captured and presented strategic epidemic intelligence detailing the emergence of the ebola virus disease (evd) on march , days in advance of the official notification of outbreak by the guinean health authorities. digital epidemiology -from expert knowledge to 'knowledge without truth' the increasing integration of algorithmically-driven infectious disease surveillance systems contemporary logics of health security are critical and significant for a number of reasons (roberts and elbe ) . first, reflective of a growing recourse to the harnessing of novel information sources to contain pandemic illness, the who, via the revision of the international health regulations ( ) , has clearly authorised the collection, assessment and utilisation of non-governmental sources of epidemic intelligence and data (article . ), without prior clearance of member-states. (world health organization ) in this regard, the algorithm emerges a new purveyor of varied, voluminous and expedited data sources to be leveraged in the risk assessment of future infectious disease threats. epistemically, what we can see is how the centralisation of the algorithm within security technologies such as digital disease surveillance systems re-contour previous relations and understandings of knowledge production, the practice of surveillance and the regulation of pandemic risk. the cultivation of knowledge to address the contingent within past 'regimes of truth' were largely sustained, as illustrated by foucault by the 'avalanche of statistical numbers' (hacking ) . increasingly however, within these contemporary security technologies, the vs of big data (volume, variety, and velocity) are now being mined, scanned, and reassembled via algorithmic processing of data to produce findings and alerts on the next pandemic. information and 'truths' about the physical world and the contingent threat of infectious disease are increasingly extracted in the forms of signals and signs of the realm of the digital, and no longer solely generated from statistical processes via human analysis. furthermore, as the conceptual work of antoinette rouvroy ( rouvroy ( , rouvroy ( , , has demonstrated, algorithms have emerged within health surveillance technologies as purely 'rational' or 'objective' instruments of forecasting, indifferent to the causes of phenomena and seeking only to accrue maximal reservoirs of data to address that which constitutes the contingent or the uncertain. what this means therefore is information and knowledge generated by these algorithmic techniques now appear to bypass the traditions of human assessment, analysis, hypothesis, testing and trial which were essential to the statistical calculation of the contingent. rouvroy has referred to this dissemination of this new form of understanding future-situated uncertainty as "knowledge without truth", represented in the context of this discussion by disease tracking systems including gphin and healthmap, which have, with upward intensity sought to apprehend infinitely expanding data sources through an intensified recourse to algorithmic-suffused disease surveillance. what is absolutely vital to emphasise here is that amid the widespread deployment of big data analytics and increasingly sophisticated algorithms for tracing the next outbreak, little critical assessment has been formulated by global health security theorists and practitioners on the ramifications 'digital' turn of health surveillance and the implications of big data and algorithmic surveillance practices on individuals, populations and states. thus, these continued shifts towards employing advanced algorithms to make sense of unprecedented amounts of information (leese ) , across practices of contemporary disease surveillance must be continually matched with equally robust interrogations of the unforeseen or unprecedented implications of securitization by algorithms in the realms of ethics, law, politics and society. thanks, stephen for underlining the function of algorithms in current approaches of disease surveillance in global health policies. in addition, i pose that the rationale of an 'emerging diseases world view' (king ) is similarly influential for public health surveillance on a domestic scale. especially in the us, systems of syndromic surveillance have been explicitly employed to answer the challenges of the 'next pandemic' with a new algorithmic form of public health monitoring. going a bit into the details of one specific example of syndromic surveillance, i want to illustrate the problem of "knowledge without truth" stephen mentioned above. the argument is that those systems 'call back' in several ways, influencing both truth claims and practices of public health provision. my empirical example is a study on the use of the "electronic surveillance system for the early notification of community-based epidemics" (essence) in the u.s. national capitol region, an application of syndromic surveillance that received considerable attention as a pilot project (füller ) . technically the essence system provides the server infrastructure to draw together diverse data-sources that are considered indicative for public health. its 'syndromic' approach consists in the integration of several so called surrogate data, signals of diseases or public health problems generated before a confirmed medical diagnosis (velasco et al. ). in the case of essence, such surrogates are for example emergency department chief complaints, daily over-the-counter sales of the two big pharmacy chains cvs and rite aid, reports on absenteeism data gathered from public schools and others. essence claims to provide an unmatched situational awareness partly due to the near real-time nature of those data (collected and reported at least daily). given the amount and unstructured nature of this data, the system employs algorithms to continually search the gathered data-stream for unusual patterns and a gui to visualize and map resulting alerts. if there is an unusual coocurrence of for example the sale of headache pills and school absenteeism in a region, the system will flag out a warning. importantly, the base for this pattern recognition are at no times diagnosed health problems but assumptions generated through the association of different data sets. eventually the system promises to automatically provide an early notification of any unusual public health event before it has been medically diagnosed (fearnley ) . the turn towards infection control and surveillance in public health and the introduction of syndromic surveillance systems have both been contested early on and from several vantage points (reingold ) . the focus here is to point out the performative character of technologies and their related practices in altering the goals and modes of public health provision. my argument centers on the fact that the system is constantly producing health related truth claims. whether it is just quietly monitoringas it does most of the timeor in the rare cases that it is flagging out a public health emergency, the system claims a certain truth about the health of the monitored population. in both cases, the algorithmically produced knowledge becomes performative in different ways. both forms of truth claims illustrate the 'knowledge without truth' problematic stephen already mentioned. on the one hand, those systems introduce a new expectation and a demand to constantly assure the normal state of affairs. new technologies of surveillance are employed to be able to illustrate an absence, to be able to constantly assure that there is nothing to worry about, as kezia barker argues (barker ) . in order to be aware of unusual events, resources, work and infrastructure are invested to extensively monitor the routine state of public health. but this additionally generated knowledge does not provide a qualified, actionable truth about the state of public health. trying to see short-term events, those systems measure against the baseline of the 'normal'. in its usually quiet mode of monitoring, the systems make the implicit claim about a 'normal' , 'well functioning' , 'unproblematic' state of public health, ignoring any long-term and structural health issues. on the other hand, in the case of actually flagging out an incidence, automated monitoring systems such as essence are problematic in their rendering of disassociated facts into medical truths. the threat of an emerging public health event is especially burdening for the executive branch of the local state. decision-makers are pressured to act early, at best before the expected cascading of an infection gets out of control. this expectation makes it tempting to base a decision on the syndromic signals as they are readily available and -through the included mapping tool -often clearly localized. while those signals are explicitly handled as an additional but clearly undiagnosed source of information among epidemiologists and public health experts, for the executive branch they have a tempting appeal of providing a near real-time situational awareness and as such an actionable grasp on the emerging public health event. importantly, using essence as a base for decision-making approaches the signal as if it was an authoritative medical fact instead of just an indicator for the clustering of certain syndromes. the danger of misinterpretation as the algorithmically generated knowledge travels contexts may result in wrongly employed public health interventions with negative social effects. besides the problem of false positives prevalent to those systems (fearnley ) the system always suggests a spatialized source of the problem that may or may not be medically justified. employing public health interventions based on those seemingly objective and localized realities can easily mean the wrong allocation of scarce resources and attention or effect an unjustified stigmatization of a 'problematic' area. from my perspective, as a medical infectious epidemiologist and public health expert who advises on the development of new surveillance systems and who constantly needs to be aware of their effectiveness as well as the consequences of their use, stephen and henning's analyses offer extremely important contributions on how to think about and evaluate increasingly digitized health-and infectious disease control. to add to this, i would, in the following, like to make a few further comments about the epistemic and political aspects of the digitization of infection control. in particular, i am able to speak to activities and experiences at germany's national public health institute, the robert koch institute (rki), and to those at the world health organization (who), where i was within the framework of the west african ebola outbreak ( to ) (owada et al. ) . first of all, i agree with stephen's analysis that there is the risk, as a result of the successive propagation of algorithmic approaches and technologies for infectious disease control, an epidemiology traditionally based on diagnostic findings and controlled statistical processes is becoming increasingly marginalized and, in parallel, the necessary verification loops are being replaced in favour of 'big data' ideologies and trends of dataification. in this context, it seems to me that widespread assumptions that advance the idea that a digital, unofficial infectious disease surveillance and monitoring is quicker than traditional, official information and reporting systems need to be modified. it is true in retrospect that existing digital systems and their associated early warnings could have been faster if their first signals had been correctly named or interpreted at an early stage. at the same time, however, it is mostly ignored that even official state authorities often have knowledge about specific events at relatively early stagesonly that they either initially withhold such information or distribute it in other ways according to the official information/notification systems, e.g. the example of stephen, the authorities of guinea were aware that there was something going on, but they waited with the reporting. so have i experienced it at the who: few countries directly provided all available information to the organization. it can also be observed again and again that official information either minimizes or plays to the media or other entities in a targeted way. in this context, non-state surveillance platforms such as promed or healthmap, for example, should be commended especially for their dimension of political transparency, as they put pressure on governments not to keep information from the public as much as possible. at the same time, however, the increasingly digitized identification, analysis and distribution of epidemiological indications of infectious disease these platforms enable not only leads to increasing likelihood of false positives, but also to specific problems of an immediate, uncontrollable communication of risk. the danger of panic and the great effort required to avoid panic are to be feared. henning provides very important information in this regards. he describes that specific public health actors (here: local health authorities) may be compelled to equate technologically-generated signals with epidemiologically certified public health events, and, on the basis of these unproven indications, initiate public health measures. further, this is also a problematic development from the perspective of resource retention in an already thinly-resourced public health service. early responses and over-reactions from political decision-makers or the media are to be feared in equal measure. in the broader context of the focus and framework of a 'global health security' , such potentially exaggerated perceptions and reactions are tied to perceptions of elevated threats of infectionwhether from (quasi) natural or man-made infection (e.g., in the context of war or incidents of terror)and, consequently, to urgent demands for comprehensive and constant attention, outbreak detection, and further crisis/disaster preparedness measures. as a result of this, infectious disease epidemiology is increasingly being, in my humble opinion, in an irritating way integrated into the national and international security architectures. so it was during the west african ebola outbreak in sierra leone and liberia, two of the three hardest hit countries, that the military was constantly present in the planning of public health measures. e.g. in one situation in sierra leone i remember this resulted in prioritizing quarantining over other public health measurements like community engagement. quarantining is not per se negative but in this particular case turned out very ambivalent as the measure evoked strong resistance among the population and potential new infected individuals increasingly were actively hidden as a consequence. also in non-outbreak times, the cooperation between security forces and public health entities is becoming increasingly narrow. this can be seen, for example, in the global health security initiative, which addresses both the biological threats of pandemic flu and possible threats from chemical or radio-nuclear terrorism. these perspectives as well as the social aspects and subsequent costs of a digitized infection control should be discussed. they are closely linked to the imperatives of constant monitoring and early detection, as well as the similar focus of a 'global health security'. as such, they should be considered with the view not only to the (not new) anticipated restrictions or marginalizations associated with classical, structural and also socially-reformed, areas of public health, as well as to further possible negative costs resulting from of a 'securitized' public health. i would like to hear from you -stephen and henning -especially with regard to these broader health and social policy debates, from your social science perspectives, what is your understanding of 'global health security' in general and of the 'preemptive security logic' , which is often discussed in this context, especially? henning i would suggest to understand "global health security" as a set of preferences and truth claims that are currently framing our understanding of health issues of international relevance. this understanding results from a perspective, that interrogates threat discourses and related policies as a structured but contingent formation of problem descriptions. problems do not exist 'naturally' but they have to be articulated and put on the agenda in a process of social interaction. this approach draws back to michel foucault and his proposal to acknowledge a power/knowledge nexus in general and specifically the power effects of truth claims. according to this, articulating and framing an issue are powerful ways to predetermine the range of thinkable approaches and solutions. by using the term "global health", policy-makers, non-governmental actors and academic observers are drawing together several health problems into a common frame, but also marking this frame as a field of intervention and claiming its relevance. the contours of this frame are still blurry and there exist numerous approaches to define "global health" (brown et al. ; farmer et al. ; fassin ) . there is no accepted definition and "global health […] is more a bunch of problems than a discipline". (kleinman ) the ongoing emergence of a problem field "global health" is an interesting moment then, where new truth claims are put forward and a new understanding of related issues such as 'health' and 'the global' are formed. those newly related ideas are powerful as they are confining the agenda setting and plausible goals and methods of intervention. approaching "global health" from this angle, what is striking from the outset is a strong undercurrent of security. the recent surge of "global health" can be attributed to a confluence of two separate discourses. on the one hand, globalization is increasingly narrated as a health risk. an "emerging diseases" discourse paints the picture of a global spread of infectious diseases due to unparalleled levels of global connectivity and frequency of global travel (barrett et al. ). on the other hand, the concept of national security is being reimagined, facing a new multi-polar and complex world order. today, in order to achieve national security, one has to look beyond military dominance and to take societal issues such as health, poverty but also climate change as security threats into account (redclift and grasso ) . for example in the us, facing the threat of bioterrorism, public health has become a concern for the department of homeland security and international infection control resurfaced as a security issue. both the fear induced by 'globalisation of disease' and the rethinking of national security are underlining a new relevance of global health issues. the resulting tremendous development in global health policies and programs accordingly are often following a security rationale (genest ) . one example is the newly installed global health surveillance mechanisms and the revised international health regulations (ihr) (fidler ) . the recent conception presents global health as part of a security problem rather than as a humanitarian issue. this securitization of 'global health' has already been described in some detail (cook ; king ; pereira ) . here i want to underline the corresponding shift in the perception of threats and its implications. current problems of global health security are often depicted as essentially incalculable. emerging diseases, acts of intentional bioterrorism, food security in an increasingly global connected distribution system, antimicrobial resistant agents, − more than ever we now seem to be confronted with "unknown unknowns". we not only do not know when those events will happen, but we even do not know what the threat is exactly. the reformulated international health regulations (ihr) tellingly have shifted from monitoring a fixed catalogue of diseases to the obligation to warn about anything unexpected. according to the ihr, the national health agencies have now to signal any unspecific "public health emergencies of international concern" (world health organization ) to the who. this specific perception of "global health security problems" as incalculable threats calls for a certain pre-emptive and outbreak-oriented intervention. the implications of the employed "preemptive security" logic have been detailed in critical security studies (de goede and randalls ; lakoff and collier ; massumi ; caduff ) . as those studies have shown, preemption often demands the extension of (technological) surveillance and orients efforts towards the event and away from structural conditions. comparable tendencies have been shown for current "global health" policies, for example an orientation towards containment of an event rather than the search for a broader structural prevention (rushton ) . to sum it up, i would argue that global health is currently presented as a problem and has been put on the political agenda in a way that calls for a very specific answer in the form of a "preemptive security logic". firstly, the underlying truth claims about the problems to solve frame the emerging field of global health partly as security issue. secondly, the incalculability problem evoked in many threat discourses of current global health thinking demands a certain security rationale. the problem of an unknown unknown has to be dealt with preemptively. this way of presenting the problem of global health then implicitly constraints plausible interventions. approaching health as a security issue does often not tackle the actual problems of health on the ground. for example, this approach inclines to invest scarce resources into monitoring and surveillance rather than education and local health infrastructure. in order to reach the goal of more substantial health policies it is important to be aware of this securitization bias in the current problematization of global health. building further on excellent points articulated by henning, this epistemic shift in government and politics towards 'global health security' has been resultant, as i argue, from significant larger geopolitical transformations, and new reconsiderations of security perspective, in a post-cold war era of rapidly proliferating non-traditional security challenges, which extend beyond traditional security correlations of the state/military, are transnational or global in scope, and again, to underscore the centrality of henning's earlier points, which cannot be prevented entirely, only addressed through coping mechanisms and the development of techniques of preemption and forecasting (caballero-anthony ). the rise of global health security and its securitizing processes have transformed the ways in which international relations and global politics are understood, orientated and practiced. in the united nations security council (unsc) adopted resolution (unsc ) which emphasised that the current hiv/aids pandemic, if unchecked, posed a risk to international security and stability, marking the first time in which a health threat was discussed before the un body mandated to maintain international peace and security (fidler ) . years following the seminal security council resolution on hiv/aids, the united nations launched its first and only to date, military mission to combat the spread of an infectious disease outbreak. known as the united nations mission for ebola emergency response (unmeer), the first ever un emergency health mission sought to contain the spiraling west african ebola outbreak following the un security council resolution , which determined that the ongoing outbreak in west africa 'constituted a threat to international peace and security' (unsc ), and we can understand these grand transformations within global politics and international relations as permeated by emergent logics to preempt both occurring public health emergencies and also probable future pandemics. contrastingly, for critical theorists, global health security has emerged as a concept which denotes a novel biopolitical project, or rather, the appearance of a new governmental problem in public health: how to effectively manage 'emerging infectious diseases' at a global scale (lakoff ) . contemporary global health systems are therefore problematized not only by the rapid emergence of pathogens on a global scale, but the risk posed by these circulating pathogens are no longer calculable using tools of risk assessment, which are based on patterns of historical incidence (ibid). in this regard, global health security rationalities, i assert, galvanise and accelerate the facilitation and development of novel techniques and practices of anticipatory or preemptive security, which emphasise the real-time, continuous and cost-effective surveillance of potential disease outbreak and public health emergencies. increasingly, in an era of innumerable digital data sources, the preemption of health risks are managed and analysed via an assemblage of innovative and evolving surveillance practices which combine multiple data sources and disease-tracking techniques, enacted at local, regional and global levels. syndromic surveillance platforms, and digital epidemic intelligence systems including promed-mail, gphin, healthmap, bio-caster, epispider, and the now-defunct google flu trends can thus be conceptualised as new governmental technologies of overarching global health security practices, developed and installed around yet unforeseen events in order to halt or preempt the 'sudden, circular bolting' of pandemic phenomena (foucault ) . collectively then, in my view and building upon the expert points provided by henning, processes of securitization of global health and the rise of preemptive security logics have advanced calls for the deployment of novel security technologies and surveillance apparatuses over the past two decades. these calls have been met with the re-drawing of disease surveillance operations and the launching of new technologies which now seemingly patrol digital datascapes in the surveillance of potential public health emergencies. such novel technologies constitute critical components of an evolving ensemble of new governing practices, knowledges, techniques and rationalities of health security, increasingly influenced by digitised, automated and computerized algorithms. . as components in an emergent socio-technological apparatus of security for the strengthening of global health governmentalities, it is also crucial to consider the ways in which these expanding digital syndromic surveillance systems re-contour previous understandings of the temporalities, form and practice of preemption in the identification of forthcoming pandemics. firstly, the rise of syndromic surveillance technologies for the forecasting of probable disease outbreaks, departs significantly from previous methodologies to identify and further preempt pathogenic threats. as seen with the steady integration of algorithmic programming over the past two decades from promed-mail, to gphin, and to healthmap, syndromic surveillance technologies increasingly draw upon and aggregate open-source data pulled via algorithmic processing from the realm of the digital to inform contemporary practices of health security in the non-digital/physical world. within the politics of preemption, this marks a novel transition towards the harnessing of infinite online data sources, afforded by increasingly sophisticated algorithms to identify unusual data correlations or patterns indicative of a potential disease outbreak. in turn, this represents a process that is distinct and divergent from previous methodologies of health surveillance which utilised clinical and laboratory testing, analysis, observation, and the collation of statistics in order to render visible and intelligible, occurring or emergent infectious disease outbreaks. in the new era of digital disease surveillance, the data warehouse emerges alongside the traditional clinic as a new critical site of surveillance and zone of security praxis in the preemption and surveying of disease risk. further to this, novel techniques to preempt looming pandemic threats via these digital syndromic surveillance systems now also correspond with new problematizations of data and knowledge forms in the securitization of uncertain [pathogenic] futures. unlike previous systems of infectious disease surveillance which were routinely marked by an incompleteness of data in which to understand forthcoming pandemic risks, the deluge of 'big data' of the early twenty-first century has now reversed this problematization of data.. contemporary digital disease surveillance systems and the practice of health security are no longer hindered by a scarcity of data but rather burdened by an excess of infinitely generating, unstructured and diffuse streams of digital data. in order then to preempt and track the emergence of disease outbreaks in a present world that is submerged in data sources, digital disease practices must navigate, as matteo pasquinelli ( ) writes, 'vast data oceans' to detect that which constitutes the anomaly, be it common patterns of behaviours in social media, buying or selling tendencies in stock markets, the oscillation of temperatures in a specific region, or suspicious keywords in disease surveillance networks (ibid). again, in this new practice of 'navigating vast data oceans' , the digital algorithm emerges once more as a strategic, pragmatic and celebrated technology of government with the capacity to apprehend, process and project new insights of disease patterns from troves of digital data which manifest beyond human cognitive and analytic capacities. thus, the politics of preemption in the present era of elevated pandemic threat are intimately intertwined with expanding recourses to apprehending big data sources and employing algorithmic processing techniques to produce advanced alerts, indications and insights of potential pathogenic uncertainties. indeed, during several critical public health emergencies over the past two decades, a combination of big data sources and algorithmic techniques produced meaningful and advanced insights into emergent public health emergencies, including during the early and critical stages of the emergence of severe acute respiratory syndrome (sars) in china and ebola in guinea. however, the success and rise of the algorithm in these health histories should not distract from the imperative for continued meaningful-and indeed critical investigations and interrogations of emergent digital disease surveillance practices which utilize diffuse big data sources and processing of such data streams via algorithm. algorithms are not only famously opaque, but have also been shown to be cantankerous, if not delicate technologies, illustrated famously by a false reporting of a cholera outbreak in the united states by google in , as a result of oprah winfrey picking love in the time of cholera as book of the month in her book club (simonsen et al. ). however, as technology and innovation advance, algorithms are getting smarter, more insightful and more precise, but the growing commonplace of these knowledge producing machines with intensifying technical complexities makes the monitoring and regulation of these data-processing technologies ever the more urgent and vital. the ascendancy of the era of big data and the rise of digital disease surveillance systems have afforded unprecedented new opportunities towards the enhancement and bolstering of disease detection capacities in an era increasingly preoccupied with the emergence of future security challenges-among them pandemic illness. the objective of this discussion has been to provide an overview and highlight the potential gains and benefits yielded by these new data sources and processing techniques, while also emphasising that key ethical, legal, political and societal concerns abound and must not be sidelined in contemporary efforts to accrue maximal data reserves and to effectively track and detect the next pandemic before it occurs. tim dear stephen, dear henning, thank you very much for this inspiring conversation. again, it made clear the necessity of an interdisciplinary and social sciences inspired debate about contemporary epidemiology and public health. for me three insights emerge. first of all, the gains in timeliness and scope of digital epidemiology come at the cost of providing a different type of knowledge. the information provided through such systems is not the same as the traditional expert knowledge based on human assessment, analysis, hypothesis, statistical testing and trials but an algorithmic 'knowledge without truth'. the status of this knowledge may not be totally clear in all the different contexts where it is used. this may result in ill-informed decision making. a driving force for the demand of digital epidemiology is a reformulated conception of global health. a common thread running through the diverse debates about global health policies today is the issue of security. this securitization of global health does frame current policies. specifically, threats to global health are increasingly identified as incalculable emergencies (unknown unknowns). this results in a demand for preemptive ways to act on those emergencies before they have evolved. this preemptive security logic also fosters an unlimited big data surveillance as a practice of 'navigating vast data oceans'. for sure these points need further critical examination. thus i am looking forward to future interdisciplinary exchange and discussion. biosecurity: securing circulations from the microbe to the macrocosm emerging and re-emerging infectious diseases: the third epidemiologic transition the world health organization and the transition from "international" to "global" public health non-traditional security challenges, regional governance, and the asean political-security community (apsc) cook ah. securitization of disease in the united states: globalization, public policy, and pandemics. risk, hazards crisis public policy precaution, preemption: arts and 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infectious disease surveillance in the big data era: towards faster and locally relevant systems security council resolution on the responsibility of the security council in the maintenance of international peace and security: hiv/aids and international peace-keeping operations unsc ( ) security council resolution social media and internet-based data in global systems for public health surveillance: a systematic review. the milbank quarterly world health organisation. fifty-eighth world health assembly resolution wha . : revision of the international health regulations. geneva: world health organization tim eckmanns thanks klaus scheuermann for intellectual input. german federal ministry for education and research (förderkennzeichen: gp ). authors' contributions all authors contributed equal to the manuscript. all authors read and approved the final manuscript. the authors declare that they have no competing interests. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord- - ldkbl g authors: taylor, a.l. title: international law and public health policy date: - - journal: international encyclopedia of public health doi: . /b - - . - sha: doc_id: cord_uid: ldkbl g the field of international public health and the contribution of international organizations to its development is described. the growth and elaboration of the field of international public health law in the last decade and a half is one of the most notable developments in global health policy. in this new era of global health governance, international law has an important, albeit limited, role to play in promoting and coordinating international cooperation and national action to protect and promote global health. particular attention is paid to the global health impact of international law developed under the auspices of the world health organization and the world trade organization. the growth and elaboration of the field of international public health law in the last decade and a half has been a notable development in global health policy. traditionally, public health was viewed as a realm of almost exclusive national jurisdiction and multilateral cooperation in this realm was restricted to discrete areas. public health law today remains predominantly domestic and national, but the field of international public health law is extant and growing. through the codification of binding global health law standards that regulate interstate behavior and national conduct as well as the creation of other global norms that influence state actions, international public health law has expanding significance in national public health law and policy. the domain of international public health law now encompasses increasingly diverse concerns, including aspects of biomedical science and human reproduction/ cloning, organ transplantation and xenotransplantation, infectious and noncommunicable diseases, the control of the safety of health services, food and pharmaceuticals in international trade, and the control of addictive and harmful substances such as tobacco and narcotics (grad, ) . international health law is also increasingly linked to other traditional areas of international legal concern. environmental law and the control of toxic pollutants, arms control, and the banning of weapons of mass destruction, human rights law, nuclear safety and radiation protection, and occupational health and safety are increasingly recognized as connected to public health. table hereto provides a variety of examples of the wide domain of international law related to public health, including international agreements that have positive as well as negative implications for public health. this article provides an overview of the field of international public health law. it examines the historical origins of the field and the factors contributing to its contemporary evolution. in addition, the article briefly reviews the nature and the significance of international law and the contribution of international organizations to the codification of international public health law. finally, the role of two international organizations, the world health organization and the world trade organization, in the contemporary development of international law are considered in connection with recent examples of lawmaking with important public health and public health policy implications. although public health is one of the earliest fields of international cooperation and one of the first domains in which an intergovernmental organization was created, the scope of international legal cooperation in public health was, until recently, highly limited. disease has been the unwelcome traveling companion of international commerce throughout history and international public health cooperation from the beginning was as concerned with facilitating trade as with protecting public health. the functions of the early international health organizations of the nineteenth and twentieth centuries centered on combating infectious and communicable diseases and preventing their spread across international boundaries (pannenborg, ) . for example, the conseil superieur de santé (superior council of health) of constantinople, composed of delegates of the ottoman empire and the chief maritime states, was established in to supervise sanitary regulation of the turkish ports to prevent the spread of cholera. as a further example, the international legal activities of the first permanent international health organization, l'office international d'hygiene publique, were restricted to the administration of international sanitary conventions, including the international exchange of epidemiological information. international communicable disease control remained the predominant area of international legal cooperation throughout the mid-nineteenth century and most of the twentieth century. with a focus limited to international communicable disease control, public health law remained a relatively neglected field of international legal concern throughout most of the twentieth century. in particular, the world health organization (who), established in as the specialized agency of the united nations in the field of health, stood out as unique among such un agencies in that the organization traditionally neglected the use of international legislative strategies to promote its global public policies (taylor, ) . who member states also paid little attention to the potential contribution of international law in advancing global health during most of the last century. although public health remained a narrow realm of multilateral cooperation for over years, the long-standing historical connection between international law and communicable disease control pointed to the larger role that international law could serve in future international health diplomacy. in the last decade and a half, the field of international public health law has expanded significantly. the breadth and depth of contemporary international health law can be traced to a number of recent and interconnected developments, including: ( ) the impact of globalization on public health diplomacy; ( ) the growth of global concern with economic and social rights, including the right to health, and ( ) expanding appreciation of the nexus between public health law and other realms of international legal concern. globalization and the expanding domain of international health law it is widely recognized that contemporary globalization is contributing to the expansion of the field of international public health law. although increasing global integration is not an entirely new phenomenon, contemporary globalization has had an unprecedented impact on global public health and is creating new and increasingly difficult governance needs and health policy making challenges (lee et al., ) . globalization has contributed to the rapid decline in the practical capacity of sovereign states to address public health challenges through unilateral national action alone and expanded the need for health governance structures that transcend traditional and increasingly inadequate national approaches. treaty law, often referred to as conventional international law, has received new prominence as a mechanism or a tool that can be used by states to facilitate multilateral cooperation in this era of globalization, as states increasingly recognize the need for international cooperation to attain national public health objectives for which domestic law and other policy responses are increasingly inadequate (taylor, ) . for example, rapid worldwide dissemination of recent advances in scientific knowledge and technology has encouraged international cooperation in a wide range of treaties, including those concerning the safety of chemicals, pesticides and food, and the disposal of hazardous wastes. globalization has increased the need for new, formalized frameworks for international cooperation, including international law, to address emerging global health threats. for example, the dynamics of globalization have created fertile global breeding conditions for the crossborder spread of emerging threats to health, such as weapons of mass destruction, including bioterrorism; emerging and reemerging infectious diseases; and noncommunicable diseases including tobacco use and obesity. in addition, globalization has expanded global interest in codifying new international commitments to protect the health status of poor states that have not benefited from globalization -the so-called losers of globalization. for example, the need to promote more equitable innovation and universal access in health-care products, including medicines, pharmaceuticals, diagnostics, and medical devices, is generating ongoing debate about the efficacy of codifying a new international instrument on medical research and design. because of the momentum of globalization, states must increasingly turn to international cooperation in order to protect and promote domestic health. consequently, we are likely to see wider use of international legal instruments in this century to control the risks and threats to health associated with globalization and, perhaps, to take advantage of the opportunities to improve world health that have been afforded by global change. for example, the who international health regulations, the sole international legal instrument designed to provide a framework for multilateral efforts to combat infectious diseases, were revised in to address the increasing threat posed by the transnationalization of infectious diseases and to incorporate newly developed mechanisms for international coordination and response. the evolution of international health law in the last decade and a half is very much tied to the protection and promotion of human rights related to physical and mental integrity. the principal international legal basis for the right to health is found in the core instruments of international human rights law promulgated under the auspices of the united nations: the international bill of rights, which consists of the universal declaration of human rights ( ) , the international covenant on economic, social and cultural rights ( ) , and the international covenant on civil and political rights ( ) . despite the historic linkage, the strong connection between health and human rights has only recently received significant attention. a number of emerging global concerns, including hiv/aids and women's health issues, including rape and other forms of violence against women, brought the intrinsic connection between health and human rights to the forefront of international policy concern beginning in the late s and early s. of particular importance was a pioneering human rights approach to the global hiv/aids pandemic adopted by who in the late s. it is widely recognized that this novel emphasis on the linkage between public health and human rights law had a groundbreaking impact in that it compelled governments to be publicly accountable on an international stage for their actions against persons living with hiv/aids (gruskin and tarantola, ) . ultimately, this innovative global political approach to public health issues publicly highlighted for the very first time the underlying legal responsibility of governments to protect and promote the health of their populations and has served as a forerunner for increasingly widespread links between human rights and other public health issues (mann and tarantola, ) . the domain of health and human rights has expanded significantly under the auspices of agencies and organs of the united nations and other international organizations. specific international legal instruments addressing the rights of particular populations, such as persons with hiv/aids, women, children, migrant workers, and refugees have recently been adopted. as a further example, on december , , the united nations general assembly adopted the convention on the rights of persons with disabilities, a comprehensive and integral international convention on the protection and promotion of the rights and dignity of persons with disabilities. other contemporary developments are contributing to the further elaboration of international legal instruments in the realm of health and human rights, including, in particular, globalization. for example, widespread recognition of growing inequalities in health status and differential access to medical advances in rich and poor states has expanded interest in the relationship between social and economics rights and health. of particular concern is the impact of international intellectual property protection under the world trade organization trips agreement, discussed in the section titled 'the world trade organization: trade related aspects of intellectual property agreement and access to essential medicines,' in restricting access to essential medicines, particularly hiv/aids antiretrovirals, in most developing countries. the unprecedented human catastrophe posed by hiv/ aids has led the international community to adopt a number of nonbinding resolutions at the united nations general assembly, the former united nations commission on human rights and the world health organization specifying the relationship between hiv/aids, human rights, and access to medicines. most recently, in june , the united nations general assembly adopted a political declaration on aids (un res. / ) reaffirming that access to medicines in the context of pandemics, including hiv/aids, is one of the fundamental elements to achieving full realization for everyone of the international right to health. globalization is also furthering the elaboration of international instruments in this realm because increasing global integration is compounding the impact of other contemporary global developments associated with health status and human rights. for example, the spread of communication and information technologies has dramatically accelerated the rate of scientific progress as well as its global diffusion. for instance, the implications of recent advances in biotechnology for the protection of human rights and human dignity have also been a topic of recent interest by international and regional organizations, including consideration of bans on novel technologies. in , the united nations educational, scientific and cultural organization (unesco) adopted a nonbinding instrument, the universal declaration on the human genome and human rights. in addition, in the wake of failed treaty negotiations, in the united nations general assembly adopted a declaration urging member states to prohibit reproductive cloning as incompatible with human rights. at the regional level, the council of europe adopted a convention on the protection of human rights and human dignity with regard to the application of biology and medicine: the convention on human rights and biomedicine in . protocols to the convention -separate agreements -on human cloning, biomedical research, and transplantation have also been adopted by the council of europe. finally, it is important to note that the rapid expansion of the domain of health and human rights also serves as an important illustration of another interconnected factor contributing to the breadth of contemporary international health law: the increasingly recognized nexus between public health and other international legal concerns. the expanding domain of international health law can be understood, in part, as a product of recently enhanced appreciation of the interconnectedness of contemporary global concerns and, concomitantly, the linkage of health to other legal issues. international legal scholars have traditionally compartmentalized and treated substantive subject matters such as human rights, environmental protection, arms control, and public health as discrete selfcontained areas with limited connections. rapid global integration propelled by contemporary globalization has contributed to the fairly recent recognition of the nexus among different realms of international law. as a consequence of issue linkage, international health is increasingly understood to be a central component of other international legal regimes, including labor law, human rights, arms control, and international trade. the recent connection between health and human rights in contemporary international law and practice discussed in the preceding section is an important example of the linkage of two traditionally distinct realms of international law. the evolution of the concept of human security provides another interesting example of this development. the traditional understanding of human security has come under increasing pressure in recent years, with growing support for a comprehensive approach to human security that addresses the wide-ranging factors that impact upon the vulnerability of people. in , the un commission on human security released a report proposing a new security framework and recognizing the linkage between health and human security (united nations commission on human security, ). in addition, expanding global concern with weapons of mass destruction and terrorism has underscored the strong interconnection between public health and security. for example, legal commitments established under who's new international health regulations, described further herein, are clearly designed to apply to releases of biological, chemical, and radiological events, accidental and deliberate. the nature and sources of international law understanding the implications of recent developments in international health law, including those for domestic public health policy, requires some appreciation of the nature of international law and the international political system. since the end of the thirty years war in , the global political system has principally involved the interactions of sovereign states. consequently, the elaboration of international law has focused on the establishment of consensual rules concerning the status of states and their fundamental rights and obligations as well as commitments. international law, therefore, is primarily focused on the interactions of sovereign states and can broadly be defined as the rules that govern the conduct and relations of states. international law is traditionally understood as consisting of two core realms: public international law and private international law. while public international law is primarily concerned with the relations of states, private international law focuses on the law of private transactions of individuals and corporations. the traditional distinction between public and private international law persists even though it is not fully accurate. for example, much of private international law concerns the transactions of public entities. in addition, while states are the primary subjects of public international law, they are not the only subjects. international organizations and, through the development of international human rights law, individuals, as discussed above, are now considered subjects of public international law. in international law, the sources of legal rules are very different than in most domestic legal systems because the global political system of sovereign states differs fundamentally from domestic political systems. while there are important differences in the sources of law among countries, domestic law generally comes from national constitutions, municipal statutes, parliamentary or executive regulations, and decisions of municipal courts. in contrast to domestic political systems, there is generally no supranational authority within the international system to develop and enforce law against sovereign states. in the absence of a supranational authority, states establish the rules of international law. article ( ) of the statute of the international court of justice is generally regarded as an authoritative list of the sources of international law ( table ) . although there is a wide and complex array of international legal sources, most international law today, including international public health law, can be found in treaties. the word treaty is a generic term that encompasses all written instruments concluded between states by which states establish obligations by and among themselves. treaties function essentially as contracts between states whereby states make binding written rules to govern their own conduct and the conduct of their individual and corporate nationals. when states become parties to treaties, they explicitly agree to limit their sovereign freedom of action in some respect to achieve mutually agreed-upon goals. generally, treaties are only binding upon states that give their express written consent. treaties are also subject to a significant corpus of international law: the vienna convention on the law of treaties (the vienna convention). the vienna convention, the so-called law of treaties, provides general rules of treaty implementation and interpretation. the vienna convention confirms the generic use of the term treaty by defining a treaty as 'an international agreement concluded between states in written form and governed by international law, whether embodied in a single instrument or in two or more related instruments and whatever its particular designation.' the terms treaty, convention, protocol, and pact are largely used interchangeably in international legal parlance. article of the vienna convention sets forth the basic legal principle concerning the observance of treaties, pacta sunt servanda: 'every treaty in force is binding upon the parties to it and must be performed in good faith.' a second important source of international law is customary international law. analogous to domestic table statute of the international court of justice the court, whose function it is to decide in accordance with international law such disputes as are submitted to it, shall apply: a. international conventions, whether general or particular, establishing rules expressly recognized by the contesting states: b. international custom, as evidence of a general practice accepted as law; c. the general principles of law recognized by civilized nations; d. subject to the provisions of article , judicial decisions and the teachings of the most highly qualified publicists of the various nations, as subsidiary means for the determination of rules of law legal concepts such as usage of the trade and course of dealing, the idea behind customary international law is that widespread international practice undertaken out of a sense of legal duty creates reasonable expectations of future observance and constitutes implicit consent to the creation of legal rules. the determination of whether or not a particular practice constitutes customary international law is a complex analysis that is more like an art than a science. but, generally, the determination requires near uniform state practice undertaken because of a sense of legal obligation. with some important exceptions, once a rule is recognized as part of customary international law, it is generally considered binding upon all states. for example, the vienna convention is accepted as declaratory of customary international law and binding for all states, including those that have not formally ratified it. like treaty law, customary international law is said to emanate from the consent of states. states party to a treaty explicitly consent to be bound by codified rules, whereas with customary international law states implicitly agree to be bound to particular rules through consistent state practice. in addition to binding international law, states produce a wide variety of nonbinding international legal instruments that can have an important impact on state behavior. such instruments include resolutions, declarations, codes of conduct, guidelines or standards. however named, general declaratory resolutions are, for the most part, intended to be nonbinding instruments expressing the common interest of many states in specific areas of international cooperation. of course, nothing in such resolutions prohibits states from incorporating the terms of the instruments into national law. one well-known example of a nonbinding international code in the public health field is the who code of marketing breastmilk substitutes. although generally nonbinding, such instruments are not without significance. like treaties, these nonbinding instruments can be mechanisms for advancing international consensus on rules and for promoting consistent state action. for example, the wto doha declaration on trade and public health, discussed below, is widely considered to have advanced global understanding and, perhaps, action on trade and health matters, particularly in relation to access to essential medicines, even though the legal significance of the declaratory instrument is unclear. at times such intergovernmental resolutions have been highly persuasive and the conduct of states has tended to follow the principles embodied in these resolutions. the effectiveness of some nonbinding intergovernmental resolutions in promoting international cooperation has led some commentators to refer to them as soft-law, although the term is highly controversial. such instruments are often carefully negotiated and, at times, drafted with the intention to influence state practice. soft-law instruments, at times, have also paved the way for the evolution of treaty law by generating an on-going diplomatic forum. it is important to recognize that not all resolutions lead to the development of formalized obligations or are a significant factor in state practice. however, intergovernmental resolutions, particularly resolutions of the un general assembly that are supported by influential states often have a political significance that can stimulate national behavior and lead to the eventual development of binding international law. it is important to recognize that international law is an inherently imperfect mechanism for international cooperation. the innate weakness of international law stems in large part from the core principle of state sovereignty. the law that is made and the law that is implemented depend upon the will of states. in the treaty-making process, states are explicitly agreeing to make rules to govern and, thereby, limit their own conduct and that of their nationals through the development and implementation of legislation and other policies, depending upon the terms of the treaty, which are consistent with their international commitments. the concept of sovereignty looms large in the international system and states are generally loath to sacrifice their freedom of action through the development of binding international obligations. a related weakness stemming from the principle of sovereignty is the general lack of enforcement mechanisms in most contemporary economic and social agreements. in contrast to the dispute resolution mechanism established under the wto, described below in the section on the 'world trade organization', in most social and economic treaties states do not include machinery to compel parties to comply with their international legal commitments. the fact that many treaties tend to be well respected in practice largely ref lects the fact that they are generally seen as mutually beneficial for states' parties. in addition, there is increasing awareness that the failure of states at times to implement international commitments may reflect more a lack of capacity than political will. many states, particularly developing countries, face acute problems of limitations of resources and capacity in implementing contemporary treaties. recent advances in the international legislative process have expanded mechanisms to address these problems of domestic capacity through international technical and financial assistance programs incorporated in the texts of relevant conventions. international law and the international legislative process suffer from other important difficulties. notably, the international legislative process itself is characterized by numerous challenges and limitations -including challenges to timely national commitment by states through timely treaty ratification and implementationalthough considerable advances have been made in the last few decades. an emerging challenge in international health lawmaking is the limited scope of entities that are subjects of international law and thereby entitled to participate in international agreements and hold rights and duties thereunder. as described above in the 'nature and sources of international law' section, states have traditionally been the sole subjects of international law. the scope of international law was only expanded in the twentieth century to include individuals and international organizations. however, the nature of global health and the major actors in health policy are changing in such a way that challenges this restricted approach to international legal cooperation. to begin with, in an era of globalization the exclusive focus on territorial statehood is irrelevant to global health policy. non-states ranging from taiwan to palestine are excluded from a range of international agreements because of lack of statehood. in addition, the major actors in global health policy today, including foundations, most notably the bill and melinda gates foundation, and a wide range of significant public-private partnerships, such as the global alliance for vaccines and immunizations and the global fund for aids, tuberculosis and malaria, or civil society organizations, such as medicines sans frontiers, are also excluded from the international lawmaking process. a major challenge for this century is to establish mechanisms to promote more effective cooperation between states and the other major health actors under international law. despite the conspicuous limitations of the international lawmaking process and the inherent challenges of using treaties to promote collective action, treaties can be useful for raising global awareness, and stimulating international commitment and national action. as an increasing number of health threats are global in scope or have the potential to become so, international legal agreements are likely to become of increasing importance and an essential component of global health governance. consequently, international legal agreements are likely to become an increasingly important factor underpinning and guiding national policy and action on health. the process of international lawmaking, like the identification of international legal rules, is very different than it is in most domestic legal systems. the unique character of the international lawmaking process, like the international legal rules themselves, can be understood as a consequence of the core principle of state sovereignty. in the international political system, there generally exists no supranational authority to make binding international rules. international health law is largely treaty-based and most international treaty making today is typically conducted under the auspices of international organizations. the vast majority of international legislative projects tend to be undertaken at public international organizations because such institutions function as formal mechanisms for multilateral negotiation and cooperation for their member states. international organizations can anchor and facilitate treatymaking efforts because their organizational structures and administrative arrangements enable them to serve as stable and ongoing negotiating forums. in recent years, there has been considerable development in the field of international organization with a significant increase in the number of international organizations active in the domain of health. within the united nations system, for example, organizations with significant involvement in the health sector include who, unicef, fao, unep, undp, unfpa, and the world bank. overall, an increasing number of international organizations have served as platforms for the codification of international health law, while others have had a significant influence on the development of international law in this field. it is important to recognize that not all international organizations have lawmaking authority or the legal mandate to serve as a platform for international health negotiations. the world bank, for example, is an organization that is highly influential in the field of health but has no actual legal authority to serve as a framework for treaty negotiations. in the international legal system, lawmaking authority is always expressed and never implied. the existence and scope of lawmaking authority can generally be identified by carefully examining an organization's constituent instrument, typically its constitution. today there is considerable jurisdictional overlap in the field of international health lawmaking. unlike most domestic systems where lawmaking efforts are largely coordinated into an integrated legal system, in the international legal system lawmaking efforts among different international organizations are notoriously uncoordinated. in the absence of an umbrella organization to manage lawmaking efforts, the proliferation of international organizations with overlapping legal authority and ambitions is creating the risk of institutional overload and inconsistent standard setting (taylor, ) . for example, during the early stages of the who framework convention on tobacco control negotiation process, other international organizations initiated novel efforts to negotiate binding instruments on global tobacco control. in , the pan american health organization, a regional office of who with separate constitutional status, initiated efforts to develop a regional treaty on tobacco control under the auspices of the organization of american states. as a further example, in the secretary general of the world customs organization (wco), an international organization outside of the united nations framework, advanced efforts to develop a wco treaty on global tobacco control. while both of these overlapping treaty-making efforts ultimately failed, problems of jurisdictional overlap and inconsistent standard setting are occurring in other realms. international law allows considerable f lexibility in the process by which multilateral agreements are developed. the primary source of international law governing the creation of treaties, the vienna convention, provides a limited number of ground rules for the conclusion of treaties, concerning the capacity of states to enter into agreements, adoption and authentication of a treaty by a valid representative, and expressions of consent to be bound by a treaty. beyond these few basic requirements, the vienna convention does not mandate any particular methods of negotiation or ratification. in the absence of binding international rules, international organizations have adopted a wide variety of strategies to initiate, negotiate, and conclude international agreements. despite the differences in legal processes the treaty-making process generally consists of four stages: initiation, negotiation, adoption, and entry into force (szasz, ) . negotiations are the most difficult and generally the longest substage of the treaty process. in practice, all recent public health negotiations have been open to participation by all states or all states' members of the international organization sponsoring the negotiations. the world health organization, the largest international health agency and one of the largest specialized agencies of the united nations system, has wide-ranging responsibilities to address global public health concerns based upon responsibilities assigned by its constitution and by its affiliation with the united nations. the structure of the relationship between who and the united nations, a separate international organization, is grounded in the united nations charter and, in particular, those sections that describe the objectives of the united nations. article of the charter describes the goals that the united nations has pledged to promote among its members, including solutions to international economic, social, health, and related problems. as the united nations specialized agency with the constitutional directive to act as 'directing and co-ordinating authority' on international health work, who has the cardinal responsibility to fulfill the aims of the charter with respect to health. who's broad authority to serve as a platform for international health lawmaking is expressly established by the terms of its constitution. article of the who constitution specifies that the world health assembly, who's legislative body composed of all of its member states, 'shall have the authority to adopt conventions or agreements with respect to any matter within the competence of the organization'. article of the constitution defines the objective of who as 'shall be the attainment by all peoples of the highest possible level of health.' the broad scope of who's mandate under article vests the organization with the legal authority to serve as a platform for conventions and agreements that potentially address all aspects of national and global public health, as long as advancing human health is the primary objective of such instruments. despite who's wide authority in the field of international health lawmaking, it has only recently used its constitutional authority to develop conventions by serving as a platform for the negotiation of the who framework convention on tobacco control (fctc). initiated in the early s by taylor and roemer, the who fctc was envisioned as a mechanism to promote national public health interventions and multilateral cooperation on aspects of tobacco control that transcend national boundaries. formally negotiated between and in six negotiation rounds open to all who member states, the text of the treaty was adopted by the world health assembly in may and entered into force in february . the final text of the convention cuts across a wide range of tobacco control topics, including advertising, production, smuggling and counterfeit cigarettes, warning labels, clean indoor air policies, and health education (roemer et al., ) . one of the important lessons from who's first treaty negotiation process is the significance of the international lawmaking process itself in promoting national action and international cooperation long before the treaty is adopted and formally entered into force, the 'power of the process.' it is widely recognized that who's efforts to achieve global public support for an international regulatory framework for tobacco control, stimulated national policy change in a number of countries and thus made an important, albeit limited, contribution to curtailing the epidemic well before global consensus on binding tobacco control norms was secured. the fctc negotiations were also the raison d'être for the establishment of the first global alliance of tobacco control activists, the framework convention alliance -a coalition of over nongovernmental organizations worldwide -and thus further influenced the strengthening and deepening of tobacco control legislation in many states around the world. in another recent lawmaking initiative, on may , , the world health assembly adopted the new international health regulations (ihr). as described above in the 'evolution of international public health law' section, virulent infectious diseases have a long history in civilization and international disease control was one of the earliest areas of international cooperation. who, upon its founding, inherited the responsibility for the management of the international legal regime for the control of the international spread of diseases. the ihr, first adopted by the health assembly in and last modified in , were designed to provide an effective framework for addressing the international spread of disease while ensuring minimum interference with world traffic. however, the ihr were ineffective in ensuring national action and global cooperation to stop the spread of disease. the ihr only applied to a highly narrow subset of infectious diseases and were routinely ignored by states. the magnitude of the global impact of catastrophic appearances of new infectious diseases and the virulent re-emergence of old contagions during the s and s underscored the irrelevancy of the old ihr in global health initiatives and initiated global interest in securing more effective international cooperation to control infectious diseases. although the ihr revision process has been underway since , the negotiations were galvanized by the well-publicized global threats of severe acute respiratory syndrome (sars) in late and and outbreaks of both human (h n ) and avian (h n ) influenza less than a year later. the sars epidemic spread rapidly from its origins in southern china until it had reached more than countries within a matter of months. the magnified public attention to these recent epidemics jolted global awareness of the global vulnerability spurred by the rapid spread of disease in this era of globalization as well as the necessity of international cooperation in halting the spread of deadly agents. as such the sars epidemic provided a mobilizing vision for coordinated health action. consequently, the ihr revision process provides an important lesson in the significant role played by a galvanizing event, and associated global public and media attention, in bringing states to the table in contemporary international law negotiations. the new ihr are also an important example of the linkage of traditionally distinct subject matters for the protection of global public health. the new regulations bring together under one treaty intertwined concerns of public health, security, international trade, and human rights. the complex regulations include articles divided into ten parts as well as nine annexes. the new ihr expand the scope of disease coverage, incorporate human rights principles, and institute demanding obligations for state surveillance and response (fidler and gostin, ) . the ihr were adopted pursuant to article of who's constitution, a fairly unique lawmaking device in the international system. article of the who constitution provides that regulations adopted under article are adopted pursuant to a contracting-out procedure designed to simplify and expedite the lawmaking process. regulations come into force automatically for all who member states, except for those states that notify who's director-general, the organization's executive head, of any rejection or reservations. the drafters of the who constitution severely circumscribed the scope of this simplified lawmaking process, however, by limiting the scope of the regulatory authority under article to traditional public health concerns ( table ). in the case of the new ihr, who member states who do not opt out of the ihr pursuant to who's constitution are legally required to update policy and law to comport with the provisions of the new instrument. this article would be remiss if it did not discuss the significant role of the world trade organization in international health law and policy. the connection between international trade and health is an important example of the contemporary linkage of two traditionally distinct realms of international legal concern discussed above. the growth of international trade means that the link between world trade organization treaties is becoming increasingly manifest in a wide range of areas, including table article of the constitution of the world health organization the health assembly shall have the authority to adopt regulations concerning: a. sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease; b. nomenclatures with respect to diseases, causes of death, and public health practices; c. standards with respect to diagnostic procedures for international use; d. standards with respect to the safety, purity and potency of biological, pharmaceutical and similar products moving in international commerce; e. advertising and labeling of biological, pharmaceutical and similar products moving in international commerce access to medicines, health services, food security, nutrition, infectious disease control, and biotechnology. the wto, formed at the conclusion of the uruguay round of the general agreement on tariffs and trade ( ) , is the primary international institution governing international trade with over % of world trade conducted according to its rules. the uruguay round brought about a complete overhaul of the international trading system by the conclusion of a number of new international agreements addressing trade issues and by the establishment of the new wto. certain organizational features of the world trade organization make it uniquely powerful in contemporary international relations and international law. first, as a condition of membership in the new organization, member states were required to agree and bind themselves to different agreements, contained in annexes - of the marrakesh agreement. second, the wto established a powerful dispute resolution procedure with a structured process, a prompt timetable, and the capacity to enforce rulings that is very rare in the international legal system. pursuant to the wto dispute settlement understanding, a wto dispute settlement body is authorized to formally adjudicate trade disputes between members and can authorize the winning party to apply trade sanctions if the losing party does not modify the violating law or policy. this mandatory and enforceable dispute resolution process stands in sharp contrast to the limited implementation mechanisms established by most treaties. notably, the world trade organization does not have a direct legal mandate in international health. article iii of the marrakesh agreement that established the wto, specifies that the organization shall 'provide a forum for negotiations among its members concerning their multilateral trade relations. . . .' the wto's impact on health law and policy is collateral to its role in establishing a legal framework for international trade relations. since the principal aim of the wto is the reduction of barriers to trade and not the protection of public health, the pervasive and growing influence of wto agreements on national and international health policy has been a subject of increasing concern. a number of the wto trade liberalization agreements have a significant impact on health policy. for example, the wto's general agreement on trade in services (gats) has resulted in the liberalization of international trade in health services and has exacerbated concerns about equity and quality in the health sector in developing countries. as a further example, the agreement on agriculture has had an important impact on food security through its downward pressure on non-tariff barriers to trade, opening up developing country markets to food imports from industrialized states. similarly, the general agreement on tariffs and trade ( ) has expanded international trade in harmful commodities, such as tobacco, by mandating that states lower tariff and nontariff barriers to trade. the impact of the world trade organization's trade related aspects of intellectual property agreement (trips) in impeding drug development capacity and access to medicines in developing countries has received the most public attention during the last decade. as discussed above in the 'health and human rights' section, the concern about trips has arisen particularly in the context of global access to hiv/aids antiretrovirals in poor nations. it is estimated that % of the world's population of million people living with hiv live in developing countries and that most do not have access to life-saving antiretrovirals. the trips agreement brought intellectual property rights under one common set of international rules for the first time and established minimum levels of protection that all members of the wto must accord to the intellectual property of fellow members. according to the wto, trips attempts to balance long-term social objectives of providing incentives for future inventions with short-term access to such inventions. trips is the most comprehensive agreement ever reached on intellectual property. notably, trips is one of the mandatory agreements that all wto members, including developing countries, were required to ratify. developing countries were given transition periods to bring their national intellectual property legislation in compliance with trips. by , all member states of the wto, except for the poorest, were required to be trips-compliant. the most significant aspect of trips, for public health purposes, is that it strengthened international protection of pharmaceutical patents. prior to trips, most developing countries did not recognize patents on pharmaceuticals in order to promote widespread and costeffective access to medicines through generic competition and to strengthen the development of the local pharmaceutical industry. trips requires patent protection of pharmaceuticals for years. the patent monopolies established by trips are a significant concern to many countries because such monopolies tend to increase the price of medicines and restrict generic competition. the trips agreement contains a wide range of safeguards that can be used to protect public health at the national level, including the possibility of overriding patents through compulsory licensing or parallel imports. these and other trips flexibilities as well as the legal authority of developing countries to use them to protect public health were battled out in the wto during this decade. a large part of the concern was settled in november in the declaration on the trips agreement and public health, the so-called doha declaration, discussed above, in which wto members reaffirmed the right of states to use trips f lexibilities to protect public health and, in particular, promote universal access to essential medications. although it is beyond the scope of this article to provide a detailed analysis of trips, it should be noted that the doha declaration did not solve all of the problems associated with intellectual property protection and public health. the conf lict between the imperatives of ensuring access to essential medications, particularly in the poorest countries, and providing incentives to industry to develop new products through the trips framework continues to dominate international public health law discourse. despite the doha declaration and a subsequent, related wto decision for countries that lack domestic generic capacity, few countries have instituted trips flexibilities to expand access to essential medicines and many have come under pressure from industrialized countries to provide broader intellectual property protection than that required by trips, particularly through the use of bilateral agreements. in addition, the transition period for most developing countries to become trips-compliant has recently come to an end. this means that all new medicines are and will be patented in all export-capable countries and will in all likelihood limit the supply of generics of new essential medicines in the poorest countries that depend on such imports. the battle over universal access to antiretroviral therapy is symptomatic of the overall challenge of securing access to essential medicines for developing nations. onethird of the world's population lacks access to basic medicines. the introduction of patent protection for drugs has made efforts to promote universal access more difficult by raising prices and reducing access. the failure of the international community to secure an effective mechanism under trips to ensure the production and export of essential medicines to meet the health needs of developing states as well as growing recognition of the link between access to medicines and human rights have led to proposals for a radical shift in the way in which pharmaceutical research and development is undertaken, including proposals for a new research and development treaty described above. a critical global public health challenge for the coming years will be to ensure pharmaceutical research and access to essential medicines for the benefit of all. this article has provided a broad overview of the rapidly expanding field of international health law. this is an era of significant change in health policy. over the last decade and a half, public health has emerged as an issue central to virtually all areas of multilateralism, ranging from arms control to security to human rights to trade. at the same time, the global dimensions of public health are transforming traditional approaches to public health. globalization has limited the capacity of governments to protect health within their sovereign borders through unilateral action alone and national and international health are increasingly recognized as intertwined and inseparable. in addition, the idea that governments have human rights responsibilities to protect and promote public health and can and should be held accountable domestically and internationally for their actions is gaining widespread acceptance. in this new era of global health governance, international law has an important role to play in promoting and coordinating international cooperation and national action. through the establishment of international health commitments, states legally bind themselves to establish, implement and, at times, coordinate national health laws and national health policy. the effective design and management of international health law will be one of the major challenges for global health governance in this century. recent developments in international health law and diplomacy have led to increasing calls for international lawmaking in an expanding number of areas related to public health. it is important to recognize that international law is not an appropriate policy instrument for all global health problems. given the substantial limitations of international law and the international legislative process, careful consideration should be given to the selection of global health concerns and the construction of legal regimes in future international health lawmaking enterprises. policy makers must give high priority to identifying if and how legal strategies can contribute to the agenda in international health cooperation, including, most importantly, the major challenges that plague many developing nations. at the same time, increased attention should be paid to the impact, both positive and negative, of existing international law on population health. it is hoped that increased attention to the impact of international law, most notably international trade law, will open up critical avenues for advancing human health. the internet has had a pervasive impact on communities, directly or indirectly affecting the way the majority of people in technologically advanced societies work, communicate, become informed, entertain themselves, or buy goods and services. the public health impact of the internet is also wide reaching, affecting many aspects of people's social lives and practices. the internet might be exacerbating some public health problems. for example, extensive use of the internet can increase hours of sedentary activity and cont ribute to obe sity ( lajun en et al ., ) and the inter net incr eases the accessibil ity of gambling and purchase of drugs. but it has also become central to health information for patients and the public, as well as a core element in health promotion and the provision of health care (including telemedicine). telemedicine has been defined as ''the use of telecommunications technology for medical diagnostic, monitoring, and therapeutic purposes where distance and/or time se par ates the patient an d health care provider'' ( her sh et al., : ) . however, telem edicine raises a lar ge number of issues that are more germane to the delivery and organization of clinical services, and therefore is not further considered in this article. as well, the use of the internet in public health practice is considered elsewhere. it is the personal use of websites for information, communication, and support that is the focus of this article. access to health information is a key public health and health promotion issue, and the internet is becoming the key source of information for the community. websites can incorporate a wide variety of content, including: . static website pages (e.g., information, personal stories, blogs) . tools to enable self-help or best use of health care (e.g., decision aids, referral information) . directories of other public web sources . interactive materials (including tests, online diaries, or monitoring tools) . audiovisual communication (sound and/or video) . moderated or unmoderated online peer support (bulletin boards, chatrooms, online forums) . systematic instructional programs via modules . open public access to an expert reply to emails . access to a therapist or health practitioner as part of an interactive module . real-ti me group mee tings or c lasses online ( national institu te of clini cal studies, ). foundations in public health law; human rights, approach to public health policy global health governance: a conceptual review the new international health regulations: an historic development for international law and public health the public health law manual oxford textbook of public health responding to hiv/aids: a historical perspective a new international health order: an inquiry into international relations of world health and medical care the origins of the framework convention on tobacco control general law-making processes making the world health organization work: a legal framework for universal access to the conditions for health governing the globalization of public health human security now the wto medicines decision: world pharmaceutical trade and the protection of public health international law and the environment principles of public international law, th edn public health law: power world health law: toward a new conception of global health governance for the st century global public goods for health: health economic and public health perspectives international health instruments: an overview who commission on intellectual property rights, innovation and public health ( ) public health, innovation and intellectual property rights health information on the h bastian, german institute for quality and efficiency in health care (iqwig) key: cord- -ha xts authors: thakur, aditya title: mental health in high school students at the time of covid- : a student’s perspective date: - - journal: j am acad child adolesc psychiatry doi: . /j.jaac. . . sha: doc_id: cord_uid: ha xts nan to the editor: the global impact of covid- is unprecedented and has left countries grappling with uncertainties. various public health measures all over the world have been implemented to reduce associated illness severity and mortality. countries are now coming out of 'lockdown' with cautious optimism after successfully "flattening the curve" with measures such as social distancing, quarantine and closure of public places including schools. however, the challenges related to the impact on students' mental health continue beyond this phase of the pandemic. this paper highlights key issues and offers practical solutions to address the mental health of adolescents during covid- pandemic, from a high school student's (hss) perspective. as with many schools and universities, my school has been closed since march th, , and it is uncertain when classes will resume. adolescence is a crucial period for social development. social distancing and school closures during the covid- pandemic can worsen existing mental health problems in adolescents and increases the risk of future mental health issues. a loss of routine for many students, social isolation and feelings of loneliness increases the risk of mental illness. an increase in domestic violence and abuse during this pandemic further exposes adolescents to risks of developing mental health problems. historically, schools may provide a social support network and mental health services for vulnerable teens. however, closure of schools during covid- pandemic have taken away the protective layer of school-based mental health support. closure of community agencies makes the situation even harder. conversely, the covid- quarantine has afforded time for family bonding over traditional board games and other activities. however, some students may need additional support for their wellbeing. virtual meetings with guidance counselors from schools can facilitate early recognition and referral to primary care and mental health services. within a pandemic environment of furloughs and job cuts, families may struggle to purchase technology for high schoolers who can benefit from school-based counseling support for mental health problems. efforts should be made for equitable access to technology for adolescents seeking telemental health services through school and community providers. the last few months have seen social media platforms such as instagram, snapchat, reddit and tiktok flooded with covid- materials. the information that trends on these social media sites are due to the 'likes' and 'shares' and any misinformation leaves adolescents exposed to associated vulnerabilities. the "social media infodemic" has been linked to anxiety, feeling powerless and 'catastrophizing' situations. further, covid- themed jokes and memes circulating on social media can lead to pandemic issues not being taken seriously, which increases the risk of infection, and associated distress and trauma. partnerships with parents and social influencers can guide students towards healthy information-seeking behavior and positive mental health strategies. both increased social media use and traditional forms of education moving to digital platforms have led to majority of adolescents spending more time in front of screens. excessive screen time is often associated with poor sleep, sedentary habits, mental health problems and physical health issues. uncertainty, fear of getting the virus, sleep problems and worries about the future are some of the common mental health issues impacting adolescents in the face of the pandemic. increased incidence of mental health problems including stress related disorders, depression, anxiety and substance abuse have been described in adolescents during a pandemic. quarantine, trauma and grief during the covid- pandemic further increase the risk of mental health problems. a lack of adequate support system leaves adolescents to find resources by themselves in an underfunded area that continues to face j o u r n a l p r e -p r o o f stigma. family and community supports to foster stronger relationships with children and adolescents and involvement of children safe-guarding agencies when needed can help mitigate risks. five strategies to support students' mental health during the covid- pandemic covid- is a challenging time and a multi-layered action plan to support students' mental health during the pandemic is necessary: • improving resilience of high schoolers: self-help strategies: the psychological impact of covid- on adolescents will be felt both in the short and long term and efforts should be made to equip adolescents with strategies to build resilience. students can be encouraged to create short-term goals, schedules and taught mindfulness techniques to build resilience. acts of gratitude and compassion such as helping those in need by voluntary activities can also help. • developing peer support networks (buddy system): creating a buddy system allows hss to form peer connections and check in on friends through network hubs or mentoring supports, either created by adolescents connected to each other eg, sports clubs, hobby clubs or facilitated by youth organizations. • leverage digital technology for mental health support: hss can access digital options for support and resources by exploring online portals that offer resource hubs and self-assessment tools. self-help apps, digital counseling and telemedicine services will continue to allow increased access to mental health services from home. • collaborative partnerships: community mental health organizations should partner with hss, their families and schools to co-create mental health promotion programs. covid- pandemic has provided us with an opportunity to be digitally connected and work on collaborative projects such as community mindfulness sessions. • ongoing government support through its networks: as an hss, i would like to advocate for greater cohesiveness in governance across all levels, regional, provincial, and national to mobilize and invest in community resources that promote engagement with local youth organizations. benjamin franklin famously said: out of adversity comes opportunity. covid- has presented with myriad challenges and the way we respond is going to shape the mental health of adolescents for the future. aditya thakur, student j o u r n a l p r e -p r o o f potential effects of "social" distancing measures and school lockdown on child and adolescent mental health. european child & adolescent psychiatry mental health effects of school closures during covid- . the lancet child & adolescent health covid- ) pandemic for child and adolescent mental health: a narrative review to highlight clinical and research needs in the acute phase and the long return to normality. child and adolescent psychiatry and mental health social media use during social distancing. cyberpsychology, behavior and social networking screen time for children and adolescents during the covid- pandemic ):e . -all statements expressed in this column are those of the authors and do not reflect the opinions of the journal of the american academy of child and adolescent psychiatry j o u r n a l p r e -p r o o f funding information: . this manuscript did not receive any funding support financial disclosure statement . the author has no financial interest or conflict of interest related to this manuscript. . the author wishes to disclose that he has received honoraria from children's mental health ontario (cmho) and reach out centre for kids (rock) for various volunteer roles. key: cord- -y mxnth authors: williams, roger d.; brundage, jessica a.; williams, erin b. title: moral injury in times of covid- date: - - journal: j health serv psychol doi: . /s - - - sha: doc_id: cord_uid: y mxnth health care providers are facing increased risk of moral distress during the covid- pandemic because of changes in clinical practice and resource allocation procedures. health care systems that employ a proactive approach in mitigating the lasting effects of moral distress will fare better in the long run. psychologists are well poised to apply timely psychological first aid to the crisis needs of patients, colleagues, and even themselves. key interventions are detailed, including creating and promoting safety, calmness, connectedness, self-efficacy, and hope. franklin, a -year-old, married, father of three children, was admitted as a person under investigation (pui) for likely covid- infection. he has multiple comorbidities including long-term tobacco use, congestive heart disease, chronic obstructive pulmonary disease, and diabetes. upon admission, he was found to be declining rapidly with increased oxygen need and possible escalation of care to intubation with mechanical ventilator support. his spouse was not allowed to be at bedside because of the medical center's recently implemented infection control "no visitors" policy. the icu physician told the patient's wife that there was a shortage of ventilators and that the triage team had made a negative escalation-of-care decision regarding her husband's treatment. she began begging to see her husband. as the team psychologist, you were asked to calm her and provide compassionate support. you had previously participated in the facility's scarce resource allocation discussions, and you know that her husband will die without assisted ventilation. the patient's wife began wailing from the first sentence of your conversation, which is agonizing to hear. she tells you that she has been quarantined at home alone for the past days and she desperately wants to see her husband. you provide empathic listening as you grapple with the realities of the couple's separation during his final hours. despite her incessant pleading, it is critical that you abide by the visitation policy resulting from the hospital's escalation of care model and standardized treatment protocol. this was the third case of the day for which you had been forced to "hold the line" on the nocontact policy. what is it costing you to do this work? will it ever end? will it have long-term effects on you? being forced to make clinical decisions, based on resource scarcity, that are inconsistent with therapeutic values is painful and distressing. knowing that one patient will receive lifesustaining treatment while another will be denied that same treatment takes a significant emotional toll on the care provider. being constrained by circumstances and system-issued protocols can cause an assault on the health care provider's moral core and foundational values. jameton ( ) defined this as "moral distress"-the experience of knowing the right thing to do while being in a situation in which it is nearly impossible to do it. moral distress is likely to occur in acute health-care crises because the ability to provide optimal care is not absolute, but most often relative. just because a ventilator or a necessary medication is available does not mean there is equal access for all, particularly during a crisis. the allocation choices made may result in dire consequences for some patients. these are real lives. conversations must occur with patients about the treatment (or nontreatment) decisions, as well as with the families who will suffer the pain and loss. the health care provider's sense of responsibility is substantial whether or not the individual participated in the resource allocation decisions or had to uphold the decisions with the patient and family. conflicts of interest, expressed and unexpressed biases, institutional constraints, limited resources, and personal values can become at odds. serving others is a fundamental value in the health care professional's pursuit of education, training, and career choice. altruistic goals can become overshadowed by the realization of significant personal cost in time of crisis. during the covid- pandemic, hospital psychologists are faced with the risk of illness or death of the patient as well as personal health risk. this also includes the realization of being an inadvertent carrier of disease to one's family. it is an emotional challenge to be forced to choose between your professional values and duties and the fundamental priority to protect our family from harm. this moral distress touches the deepest core of one's being. it can disrupt family systems and functional routines. some health care workers have opted to live separately from their families, either alone or with coworkers, to limit potential virus exposure to loved ones. others may not have that option. moral distress has been known to manifest as physical ailment and/or psychological suffering. muscle tension, headaches, gastrointestinal upset, and fractured sleep are common. feelings of exhaustion, frustration, helplessness, guilt, shame and worry are experienced by many health care providers. sustained distress can evolve into moral injury, which is an erosion of trust in self, leadership, and the system as a whole (shay, ) . perceived loss of ethical integrity can diminish one's personal and professional identity. therapeutic effectiveness can become compromised and isolation from professional colleagues more likely. moral injury for the health care provider can lead to burnout and even the decision to leave the profession altogether. care provision is most commonly based on patient need and within the bounds of available insurance coverage. this was true on any routine day in in most u.s. hospitals, clinics, and private practices. if an insurance policy did not cover a particular procedure or medication, another option was found that did. supplies were more abundant, and there was minimal rationing of care, services, and supplies. the covid- pandemic has fundamentally changed both practice and care decisions. national news stories highlight health care workers lacking sufficient personal protection equipment (ppe), such as being restricted to one gown and one mask per shift. graphs and charts flood social media with numbers of needed icu beds and the limited number of ventilators available. washington state was headlined with these shortages in march, new york city in april, and one wonders which cities it will be in may. will there be more beyond? the covid- pandemic response will continue to benefit from psychologists' involvement in scarce resource allocation decisions. these decisions occur on many levels whether within a medical institution or in a private practice setting. institutional policies, prevailing norms regarding terminally ill patients, institutional limitations, staffing availability, equipment, and resource capability have major influence on decision-making. not surprisingly, a tug-of-war between individual health ethics and public health ethics arises during pandemics. tensions are experienced between the needs of individual patients versus the community, patient-centered care versus the common good, and patient preference versus fair resource distribution. these disparate factors occur at all levels within the health care delivery system. emergency departments, primary care practices, specialty services, and rehabilitation and long-term care programs must adjust service provisions to meet the changing treatment demands of the pandemic. standard operating procedures are modified, and some longstanding operations must be discontinued entirely. times of crisis bring to light the challenging realities of maintaining ethical decision-making. administrators, managers, and team leaders are forced to make decisions that are both informed and participatory. yet, decision-making during a crisis typically does not permit lengthy gathering of all of the facts and all stakeholder views. a decision needs to be made, immediately. best practice would dictate employing a logical and valuebased decision-making process. these preemergency operational plans for use in crisis situations can prove invaluable. options are weighted based on organizational values, shortand long-term consequences, benefit outweighing harm, applicability of established precedents to similar cases, and rationale for how decisions are made is apparent. ethical leadership in crisis planning is a good guide for facilities delivering health care amid a pandemic. it is imperative that the psychological health and well-being of those required to implement crisis plans are addressed at all levels, from the decision-makers down to the patients served. a rational model for allocating health care resources is imperative. fortunately, many facilities have emergency plans with standardized review processes. these often-aspirational policies are met with the unforeseen realities of crisis, which demand real-time adjustments. resource capacity extends beyond limited equipment, operating systems, and physical structures. the foundational goal of resource allocation is justice and fairness, the greatest good for the greatest number of people, consistently applied. this is best accomplished through transparent, reasonable, feasible, legal, and practical means. some scarce resource allocation systems have used unfair criteria such as age, disability status, pay source, and other biased and inappropriate factors. psychologists provide helpful training for identifying biases, particularly social justice factors that result in some groups being disproportionally targeted for denial of treatment. an example is the growing evidence of racial/ethnic disparities in treatment decision. the city of chicago ( ) reported the highest prevalence of infection and mortality in black non-latinx residents among all racial/ethnic groups. compared to white non-latinx residents, black non-latinx residents had double the prevalence of infection ( . % vs. . %, respectively) and mortality ( . % vs. . %, respectively). there are clear benefits from scarce resource processes, if resources are distributed fairly and services are provided equitably. when crisis standards of care are implemented systematically, allocation plans ensure ethical quality of care, promote accountability, reduce liability risk, potentially lower the risk of moral distress, and provide a feasible road map from the chaos inherent in the crisis. allocation plans can include mechanisms to evaluate outcomes and adjust distribution based on resource availability. one well-recognized resource is "meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the veterans health administration" (pandemic influenza ethics initiative work group of the veterans health administration's national center for ethics in health care, ). scarce resource allocation processes that only assess administrators' risk obscure the patients' psychological needs and well-being. similarly, processes that solely account for frontline caregivers may be fraught with personal reactions and prejudices. several health care systems have adopted the vha ethics center guidance (noted above) regarding standard of crisis care. it guides implementation of triage protocol by emphasizing survivability rather than use of arbitrary exclusion criteria such as age, disability status, or ability to pay. the "human factor" has traditionally been missing in scare resource allocation business models. it is critical that choices are made while balancing the needs of the patient with system constraints and adopted protocols. covid- underscores the shared risk for systems, but also for patients and health care providers alike. the psychological cost of making such life and death decisions can be profound for the individuals involved. health care systems are rapidly developing and implementing support systems to address the unique demands placed on providers during the covid- pandemic. a proactive approach grounded in "psychological first aid" principles can partially mitigate the effects of moral distress in the short-and long-term (brymer et al., ; epstein & hamric, ). psychologists can apply psychological first aid principles to bolster their own coping efforts. they can do the same in their interactions with patients and colleagues, which will foster moral resilience across the health care continuum. psychologists are uniquely positioned to develop and provide education and interventions within the larger organization or the community. attending to safety concerns in times of crisis is fundamental. this involves using strategies that target both emotional needs and physical safety. psychologists can disseminate resources to assist patients and colleagues, as well as model healthy sleep, proper nutrition, regular exercise, and stress management techniques. they can engage individuals who are struggling in brief problem-solving exercises. individuals will then be able to identify and eliminate modifiable barriers that are interfering with goal attainment. mutual problem solving can be effective in a casual conversation with coworkers in the hallway or in formal psychotherapy with a patient. methods for conveying safety in clinical contexts have transformed in light of the covid- pandemic. working behind the barriers of face shields/masks and other required contact isolation gear increases the sense of distance between provider and patients as well as between colleagues. it feels unnatural to deliver health care services within these confines. face shields/masks are hot and uncomfortable, especially with extended use. simply acknowledging the frustration associated with these constraints can create a shared experience and a safer emotional landscape. in the outpatient setting, access to telepsychology services during the covid- crisis has grown exponentially, with % of practicing psychologists having moved their practices online (sammons et al., ) . the shift from in-person care to email, telephone, and video contact has necessitated changes in how psychologists establish rapport. the intersection of technology and psychotherapy can be challenging because of equipment availability and access to technology. when technology is available, attention must be given to ensuring adequate connection bandwidth, monitor resolution, camera and microphone placement, sitting position, and the focal point on the screen for natural eye contact. all of these aspects of telehealth provision can foster or compromise a sense of safety and support (glueck, ) . practicing mindfulness and teaching patients and colleagues these techniques promotes emotion regulation and reduces depression and anxiety (hempel et al., ) . two simple tools require only - s: mindful breathing and centering presence can be used during a shift or to help ease the transition from work to home. mindful breathing involves slowly inhaling through the nose, and exhaling through the mouth, while focusing one's attention on the bodily sensation of the breathing process (and letting all other thoughts go). building a centered presence involves pausing briefly before entering the next patient encounter, taking a few long, slow, deep breaths, letting the thoughts of the last encounter drift away, and calmly orienting self to the present (norcross & vandenbos, ) . identifying physical quiet spaces for staff to decompress and recharge during shift breaks normalizes that downtime is necessary amid stressful working conditions. having mental health staff available to help frontline providers process the demanding and unfamiliar situations in crisis care can help them regain their composure and focus. psychologists can also assist colleagues by providing other healthy ways to relieve pent-up energy, which contributes to agitation and detracts from efficiency and effectiveness at work and at home. psychologists have a proclivity of fostering connectedness. it is important to recognize that social distancing is not commensurate with professional isolation. we are all in this together. we cannot underestimate the power of being present, showing support, and empathizing through ever-evolving practice during a crisis. increasing caseloads require complex treatment approaches, grieving relatives are deprived of contact, and personal suffering within one's family can result in pervasive desensitization. it is important to build routines that emphasize mutual understanding of each other's struggles and contributions. it is particularly critical for leaders at all levels to voice their appreciation of staff as often as possible. this outward praise can strengthen the connection between providers and patients. likewise, being able to express concerns or distress can have utility, allowing individuals to tap into the shared experiences of personal suffering, and one's imperfections can become critical points for self-kindness that strengthen empathy when helping others (nouwen, ) . virtual peer-led support groups are another way for staff to connect, commiserate, and bolster resilience through normalization and shared problem solving. psychologists are ideal facilitators for these support forums. dialog about the clash between clinical ethics and public health ethics may be common themes in these groups. knowing these ethical principles and how they are impacting scarce resource allocation and triage protocols in hospital settings can bolster efforts to resolve moral distress when violations occur. for instance, when a patient's treatment preference to use mechanical ventilation cannot be upheld because of standardized triage decisions, identifying the principles in conflict (autonomy vs. justice) becomes an important first step in understanding why feelings of guilt might surface. subsequently, reconstructing more flexible moral schemas that integrate contextual factors can reduce a sense of responsibility and promote healing (litz et al., ). the onslaught of health care stressors during a pandemic, like those experienced in military combat, results in substantial personal and professional loss, pain, and injury. when under duress, leaders in systems may slip into harsh reactions to negative patient outcomes. organizational responses can cause providers and psychologists to feel helpless in the face of growing tragedy. psychologists are susceptible to this, too. guilt and blame associated with moral distress can undermine self-confidence. identifying and evaluating these feelings through mindfulness activities and consultation with colleagues can lay the groundwork to challenge cognitive (mis)attributions that have contributed to these emotions. redirecting attention and focusing energy on what one can control improves quality of patient care and reduces negative outcomes. although the format may vary, delivering evidence-based interventions to patients can be a powerful reminder of eventual benefit while in the midst of overwhelming circumstances. psychologists' collegial interventions can lessen the burden of staff shortages and difficult work conditions. psychologists can benefit by anchoring themselves in the intrinsic value gained from clinical activities, especially those that provide a sense of joy and confidence, bolstering satisfaction. reconnecting with personal values and a mission can provide a sense of purpose in the midst of the health care crisis. a mission can be adopted from the organization in which the psychologist works, or an expressed aim of the patients being treated, or even a personal creed of the individual provider. printing a copy of the mission and displaying it where it can regularly be seen and read is a helpful reminder, especially in times of despair. imagining the future in a positive way and sharing this vision with patients, colleagues, and leadership can birth hope. additionally, instilling hope in work rituals can have a positive effect. rather than having staff simply leave when their shift is completed, perhaps invite them to meet briefly in a common area that allows reasonable social distancing, maybe with coffee or tea, to share a positive or heartwarming event that occurred during the shift. each person can be asked to share something for which they are grateful, whether it is something at work or in their personal lives. this is an example of translating positive psychology interventions into collective debriefing and mutual support activities. the covid- pandemic has generated many sources of stress and subsequent distress for health care workers, patients, and families. it is critical to be aware of the various feelings that may arise and try not to hide emotional reactions. psychological first aid tenets provide a road map that fosters resilience for patients, providers, and health care systems to navigate the ethical dimensions of the covid- pandemic. & acknowledge stress, pressure, and sacrifice. acknowledgement from leaders and peers is vital for normalizing staff reactions and knowing that our experiences are shared. & adopt an ethical mindset. early awareness of two or more ethical principles being at odds can cause moral distress and if recurrent, moral injury. be proactive to mitigate harmful consequences. & lean on colleagues. find ways to dialog through video chat, telephone, and email. talk about your reactions and the distress you are experiencing. if moral distress-a seemingly impossible conflict between values and actions-arises, talk about it. & connect with patients. create empathic interactions despite current barriers to usual care (e.g., social distancing, ppe, intervention type). delivering evidence-based interventions promotes self-efficacy and reminds health care providers to not give up in the midst of overwhelming circumstances. & bolster resilience. there is continual need for resources that foster moral repair and resilience. without such resources, personal guilt will erode professional confidence. realize that you, your colleagues, and other health care providers may grapple with the moral residue of covid- beyond its actual period of immediate threat. national child traumatic stress network and national center for ptsd moral distress, moral residue, and the crescendo effect telemental health: clinical, technical, and administrative foundations for evidence-based practice evidence map of mindfulness. va-esp project # - nursing practice: the ethical issues moral injury and moral repair in war veterans: a preliminary model and intervention strategy leaving it at the office: a guide to psychotherapist self-care new york: image doubleday meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the veterans health administration psychological practice and the covid- crisis: a rapid response survey moral injury publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations he is the zvamc ethics consult co-coordinator as well as a member of the scarce resource allocation team and integrated ethics council. he is also an associate professor in the department of psychiatry and behavioral medicine she serves on the ethics consultation service at zvamc. she is also an assistant professor in the department of psychiatry and behavioral medicine she is a crisis intervention trainer for first responders, police and sheriff departments, correction officers, crisis negotiation teams, and federal agents in wisconsin key: cord- -rmf azon authors: maldonado-castellanos, isaac title: ethical issues when planning mental health services after covid- outbreak date: - - journal: asian j psychiatr doi: . /j.ajp. . sha: doc_id: cord_uid: rmf azon nan recently, a paper written by ransing et al. ( ) adressed a conceptual framework aiming to guide the development, implementation and evaluation of mental health interventions during the covid- outbreak. the proposed model includes the following main topics coordination and preparation, monitoring and assessment, reduction of the mental distress due to misinformation and "myths", sustainability of mental health services and communication. in addition to this, ethical considerations should be incorporated when planning novel mental health programs. it is widely known that covid- pandemic has changed people's lives. as a consequence, a new social dynamic has been stablished where people need to engage in healthy preventive behaviors by adopting social distance measures. in this respect, uncertainty on the duration of confinement actions, the unavailability of vaccines or treatments for covid- and the increase of the number of people infected might increase worry, fear, confusion, or anxiety making adaptation process difficult to these new circumstances during a public global emergency. in this context, the increase of mental health problems among socially distanced and selfisolated people is one of the major concerns encompassed by mental health professionals. ransing et al. ( ) have described that mental health problems are common during a j o u r n a l p r e -p r o o f pandemic, but they need to be well identified by proper epidemiological studies. as a consequence, people have opted the use of digital technologies like telemedicine or hotlines to cope with mental health issues during the confinement actions taken by governments to stop the spread of the virus. these alternative approaches represent a non-traditional ways of mental health services delivery that might facilitate access to health services but at the same time, they rise new ethical challenges. for instance, protection of personal data is a major concern of mental health users that might lead people to feel unsteady when talking about intimate issues ethical principles like justice, integrity, beneficence, nonmaleficence and autonomy must be incorporated in a new ethical framework to regulate the use of digital technologies related to health services. culture practices are been transformed after the covid- and new ethical controversies on mental health digital services are yet to be identified (bauer et al., ) . to accomplish this challenge, professionals need to discuss, and review topics related to informed consent, data protection, patient privacy, identity confirmation or digital medical j o u r n a l p r e -p r o o f prescription in order to incorporate these subjects when developing contemporary mental health programs. as a psychologist, i think there is an opportunity to adapt to a new social digital complexity by developing new codes of conduct aimed at psychologist, psychiatrist and other mental health professionals. things are changing. apa's ethical principles of psychologists and code of conduct and other ethical codes for psychologists and psychiatrists need to habituate to this current humanity's challenge. we are facing a paradigm shift in psychological and psychiatric services provided through digital platforms that need a comprehensive and contemporary ethical analysis. this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. author declare no conflicts of interest in connection with this paper the consejo nacional de ciencia y tecnología (conacyt) through doctoral scolarship. ethical principles of psychologists and code of conduct ethical perspective on recommending digital technology for patients with mental illness mental health interventions during the covid- pandemic: a conceptual framework by early career psychiatrists towards the design of ethical standards related to digital mental health and all its applications key: cord- - r b id authors: sun, hongpeng; zhang, qiuju; luo, xiao; quan, hude; zhang, feng; liu, chang; liu, meina title: changes of adult population health status in china from to date: - - journal: plos one doi: . /journal.pone. sha: doc_id: cord_uid: r b id objectives: the purpose of this study was to examine the change in health status of china's adult population between the years of and due to rapid economic growth and medical system improvement. methods: data from the third and fourth chinese national health services surveys covering , residents in and , residents in who were aged > years were analyzed. results: chinese respondents in were more likely to report disease than in . smoking slightly decreased among men and women, and regular exercise showed much improvement. stratified analyses revealed significant subpopulation disparities in rate ratios for / in the presence of chronic disease, with greater increases among women, elderly, the han nationality, unmarried and widow, illiterate, rural, and regions east of china than other groups. conclusions: chinese adults in had worse health status than in in terms of presence of chronic disease. china's reform of health care will face more complex challenges in coming years from the deteriorating health status in chinese adults. in recent years, the healthcare system in china has significantly improved [ , , , ] . in , beijing succeeded in the bid to host the olympic games. subsequently, chinese government and civil organizations launched extensive fitness programs for the general public to raise the level of physical activity and health. as a result, more sports facilities were built with free access in the community, there was increased parkland, and news media also participated in this campaign [ ] . china suffered greatly in the when the worldwide prevalence of severe acute respiratory syndrome (sars) took a sharp rise. since that lesson, there is evidence that chinese people have improved their general and personal hygiene and diet, undertaken more intensive physical exercise, and increased the overall frequency of hand washing [ ] . over the next years, following , chinese healthcare systems have made significant reforms, and reflected on the vulnerability of public health [ , ] . available health resources in china have been continuously increasing along with china's dramatic economic development [ , , ] . from to , the medical insurance system in china underwent rapid development and the government input among total health expenditure increased by %. a new type of rural cooperative medical care system, a form of community-based health insurance for the rural population, was piloted in some counties in ; coverage rate reached . % by december , and would gradually cover all rural residents by [ , ] . at the same time, urban resident health insurance scheme included % of cities by the end of . urban employee basic health insurance scheme in china has covered all cities since [ , , ] . with healthcare reform deepening, these systems made the proportion of out-of-pocket payments drop to % and will be further reduced in future [ ] . during the last decade, the health status of china's population has been changing. chinese life expectancy increased from . years in to years in ; infant mortality decreased from . / live births in to . / live births in while maternal mortality declined from . / , to . / , live births at the same time [ ] . although infectious disease, malnutrition, child, and maternal mortality rates have decreased, chronic and noncommunicable disease mortality has gradually increased [ ] . for example, cancer and stroke are the major causes of death, accounting for . % of all deaths in , followed by respiratory disease and heart disease; chronic and noncommunicable disease mortality increased from . % of allcause death in to . % in [ ] . on the other hand, such indicators are insensitive to nonfatal conditions that contribute indirectly to death. whether chinese overall health status changed during the period from to remains unresolved. hence it is imperative to assess population health using indicators that reflect contemporary health issues. this study aimed to describe the male and female adult chinese population health status in multiple dimensions, including overall morbidity, presence of illness in the last weeks and chronic disease in the last months, and healthy behavior as regards smoking, alcohol consumption, and physical activity, using data from the most recent national health services surveys by the chinese government in and . the main objective of these surveys was to measure performance of health systems and forecast health demand and long-term health problems. our study provided important information for furthering research questions for future studies. the china national survey employed a multistage cluster sampling to select the sample randomly. the mainland of china was clustered according to the government administrative geographic system [ ] . both surveys were conducted in the same sampling areas, whereas all households were randomly selected again. first, counties and cities were randomly selected from rural and urban areas ( areas were selected in ). second, towns were selected from each county and communities from each city respectively, resulting in towns or communities. third, villages in each town and neighborhoods in each community were randomly selected. fourth, households were randomly selected in each village or neighborhood, resulting in about , households in ( , households in ). during the survey, candidate households that could not be contacted by interviewers on three calls on different days were replaced. survey completion rate was maintained at . %. interviewers, who were trained, explained the purposes and confidentiality of the survey then invited family members to participate. residents could choose not to participate and their participation in the survey was accepted as oral consent. adult residents were themselves required to answer questions; if they were not at home at the time of the survey then their nearest relative could serve as proxy. as a result, the survey response rate for adults was % in ( . % in ). completeness of questionnaires was checked by a district survey manager at the end of each day. if there was missing information and errors on the survey, probands could be re-surveyed the next day. a % sample of households was randomly selected and resurveyed to examine survey quality by telephone or visit again; the agreement was %. the quality of survey data and consistency check demonstrated a myer's index of . ; there was no age preference in the survey. the results of goodness-of-fit showed that the sample was not significantly different with the general population in age distribution. similarity coefficient and gini concentration ratio indicated that family size in the survey was consistent with the established national picture. demographic variables included sex, age, ethnicity, marital status, education level, rural/urban residency, and geographic region. ethnicity was grouped into han or minority. educational level was categorized into five categories such as illiterate, elementary school, junior high school, senior high school, and college or university or higher. china was geographically grouped into urban (city) or rural areas (town or village) after the governmental administration system, as well as eastern china, mid-china, and western china based on economic development status; eastern china is considered the most developed region, mid-china less developed, and western china the least. information about smoking, alcohol consumption, and physical exercise were collected. presence of illness in the previous weeks and physician-diagnosed chronic diseases in the last months was recorded. the same survey method was used in both the and surveys. definitions of variables have been described in detail elsewhere [ , ] . all analyses were conducted separately for women and men, urban and rural, and total. descriptive statistics were used to test the statistical differences in sociodemographic characteristics, smoking, alcohol consumption, physical exercise, presence of illness (in the previous weeks) and chronic disease between the two surveys. because of the large sample size and multiple categories in sociodemographic characteristics variables, p-values for differences between the two surveys were not reported. finally, multiple binomial regressions with a log link were used to generate adjusted p-values to examine whether chinese residents of had better health status compared with in . clustering of individuals within family was adjusted for using generalized estimating equations in sas . proc genmod [ , ] . stratified analyses by sociodemographic variables were conducted for chronic disease to determine whether adjusted rate ratio (rr) and % confidence interval ( %ci) for / differed across strata. demographic characteristics for residents are presented in table . there was a difference in composition of some age groups between the two surveys: presence of illness in the previous weeks was (table ) . however, the proportion of drank alcohol frequently was similar between and . chinese residents in were significantly more likely to perform regular exercise than in ( . % vs. . %). compared with men, women were less likely to smoke and frequently drink alcohol in and , and had more likelihood to perform regular exercise. rural residents did less regular exercise than urban residents, and smoked more. after adjusting for independent variables listed in table our review of data for the china third and fourth national health services surveys suggests conclusions in three broad areas. first, we found that chinese population in was more likely to report illness compared with , but less likely to smoke and more likely to do regular exercise. second, chronic diseases in were more highly prevalent than in , particularly hypertension, diabetes, heart disease, and stroke. third, the disparity in the prevalence chronic disease of the two surveys was distinctly evident in different subpopulations. in the current study, we found that prevalence rates of chronic diseases in the last months before the surveys increased from to . for example, the prevalence of hypertension and diabetes in approximately doubled since , and that of stroke increased by . times. however, the prevalence of infectious disease did not change. there are several possible explanations for the above findings. first, china's population has been in very rapid transition from a youthful to an aging population as life expectancy has increased [ , , ] . birth rates have fallen, and china's one-child family policy has been a strong driver of population aging [ ] . the rapid decrease in china's birth rate, combined with stable or improving life expectancy, has led to an increasing proportion of elderly people. in , only . % of the population was aged . years; this proportion grew to . % by . in our study this proportion was . % in and . % in . the un predicts that . million chinese will be aged . years by [ ] . this so-called graying of china's population has increased the incidence rates of diseases associated with elderly populations, and will become more problematic in future [ ] . second, many of the known risk factors for chronic diseases have dramatically increased as societal change progresses. these behavioral elements include changing diets, levels of physical activity, and alcohol and tobacco consumption and have accelerated shift at a historically unprecedented pace and scale in china. dietary grains intake decreased substantially, whereas that of meat, fat, and edible oil increased [ , , ] . consequently, obesity in chinese people has increased as well as hypercholesterolemia [ , ] . obesity is a major public health problem since it contributes to development and exacerbation of major chronic diseases [ , , ] including heart disease, type diabetes, and some cancers. in addition, the increase in overweight people and obesity can be attributed to physical inactivity [ ] . physical activity helps a person maintain better posture and balance, stronger muscles and bones, more vitality, reduced stress, and continued independent living in later life [ ] . although the present research revealed that chinese adults were more physically active in compared with , only . % of adult residents reported exercising $ times per week. this may be due to improved access to physical activities or enhanced awareness of health. however, overall chinese adult population health status has not been improved due to short time and small proportion of residents performing frequent exercise; hence it seems that the prevalence and burden of chronic diseases will continue to grow. the third possible explanation is that the prevalence of hypertension in china has been rising rapidly during the period from to . our results indicate that the prevalence of hypertension in the last months before the survey has doubled from . % in to . % in ; and . % of chinese people had been diagnosed with hypertension by medical doctors. however, the true prevalence of hypertension should be higher than reported because of respondents' unawareness of their condition. previous national studies suggest that the prevalence of hypertension in the chinese adult population has increased from . % in , to . % in , to . % in , and to . % in [ , , ] . nevertheless they should be compared cautiously owing to methodological differences in sampling and to differences in the criteria used to define hypertension. in addition, control of hypertension in china is far from optimum. according to the national nutrition survey of , . % of chinese adults had hypertension, and of the % affected individuals who were aware of their condition, % were treated and % adequately controlled [ , ] . at the same time, . % of diabetes patients took medication and . % achieved controlled diabetes [ ] . therefore a national education program that can eliminate the huge gaps among presence, awareness, treatment, and ability to control of hypertension and diabetes should be given to the public, clinicians, and healthcare decision makers. fourth, insurance coverage that has been increasing in china, leading to higher health services utilization [ ] . previous national health services surveys revealed that the -week consultation rates were . % of urban residents and . % rural residents in [ ] . the percentages increased to . % of urban and . % rural in . therefore chinese adults in seemed more likely to detect disease. the increasing range in the prevalence of chronic disease was more significant in women, han chinese, elderly, widowed, illiterate, rural, and eastern china than other subpopulations. the presence of chronic disease is rapidly increasing among more affluent people. for example rural residents, who have benefited from china's economic development similarly to urban populations, have experienced dramatic lifestyle changes in the past two decades. they are doing less physical work owing to mechanization and eating more high-protein or -fat food; and are therefore more likely to be aware of the presence of chronic disease and insurance coverage, especially the new rural cooperative medical care scheme, more health service utilization, and better transport have enabled rural residents to visit physicians [ , ] . as a result, they are more likely to report illness. social determinants of health have become important factors associated with the decline of health status. our findings suggest that to promote health status we should focus on elderly and widowed people and promote higher national educational level. prevention strategies such as reduction of tobacco use, exposure to second-hand smoke, less dietary intake of salt and fat, and promotion of increased physical activity should also be prioritized. there are four major limitations to this study. a major limitation is that data were collected through two cross-sectional surveys, whereas the two questionnaires did not have precisely the same structure. also, the cross-sectional nature allows for errors in recall. a second limitation is that the present study was based on observational data; therefore we cannot be completely sure of the association between demographic characteristics and health status, even after controlling for potential confounders. a third limitation is that we only analyzed seven major risk factors but were unable to assess other important risk factors of diet and obesity. the fourth major limitation is that the prevalence of chronic disease was likely underestimated because only physician-diagnosed chronic disease in the last months was recorded. however, this study mainly explored relative change for presence of chronic disease from to . some bias in both cross-sectional surveys could be offset to some extent. despite these limitations, our findings make a significant contribution to address the health characteristics of chinese adult population. additional research is needed to explore the reasons for the patterns we found, including how the outcomes examined in our study might differ for rural residents compared with urban residents. future studies also might explore how types of health insurance might be related to health status. in conclusion, our analysis demonstrates that chinese adults in had worse health status than in terms of presence of various chronic diseases. especially, prevalence of hypertension and diabetes in was twice that in . however, smoking showed slight decrease among men and women, and regular exercise suggested much improvement. our results also indicate that prevalence of chronic illnesses increased more among women, elderly, han chinese, unmarried and widowed, illiterate, rural, and those in eastern china. public health policy should pay explicit attention to these issues. as economic development and environmental degradation continue, systems of disease prevention and health promotion in china will face ever-bigger difficulties and challenges. adjusted p value , . for versus after adjustment for age, minority, marital status, education, gender (or 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implications trend of population aging in china and the strategy the sixth national population census main data communique in china's family planning policy: an overview of its past and future tackling the challenges to health equity in china emergence of chronic non-communicable diseases in china the nutritional status and dietary pattern of chinese adolescents a new stage of the nutrition trends of obesity and underweight in older children and adolescents in the united states obesity: preventing and managing the global epidemic is china facing an obesity epidemic and the consequences? the trends in obesity and chronic disease in china human body composition and the epidemiology of chronic disease who reassesses appropriate body-mass index for asian populations overweight and obesity in china prevalence, awareness, treatment, and control of hypertension in china: data from the china national nutrition and health survey hypertension prevalence and status of awareness, treatment and control in china a description on the chinese national nutrition and health survey in the authors thank the china ministry of health for providing the data for the analysis. conceived and designed the experiments: ml hs hq. analyzed the data: hs qz. wrote the paper: hs xl fz cl. key: cord- - q h bwj authors: goswami, mridula; sharma, sadhna; kumar, gyanendra; gogia, monica; grewal, monika; garg, aditi; bhardwaj, sakshi; vignesh, ramanand p; narula, vashi; bidhan, ravita title: dealing with “coronavirus pandemic”: a dental outlook date: journal: int j clin pediatr dent doi: . /jp-journals- - sha: doc_id: cord_uid: q h bwj an emergent pneumonia outbreak, denoted as coronavirus disease- (covid- ) by the world health organization (who) originated in wuhan city, in late december and spread at an alarming rate to become a pandemic affecting more than countries. the covid- is caused by a novel coronavirus ( -ncov), which is highly contagious and is associated with a high mortality rate. the current covid- outbreak has created a major havoc among every strata of the society with a detrimental impact on healthcare professionals, including dentists limiting their capabilities at large. the transmission of virus through aerosols produced by high- and low-speed handpieces, ultrasonic scalers, air/water syringes, or an infected patient coughing, and even when taking intraoral radiographs has made it difficult for dental personnel to provide even the most basic services to the needful. the virus survives on environmental surfaces for extended periods of time, including metal and plastic surfaces commonly found in dental offices making it utmost necessary to follow the precautions and recommendations issued by various organizations in order to contain its spread. this article aims to provide the latest knowledge encompassing the various aspects of covid- to pediatric dentists in india. how to cite this article: goswami m, sharma s, kumar g, et al. dealing with “coronavirus pandemic”: a dental outlook. int j clin pediatr dent ; ( ): – . the human body is prone to a plethora of infections caused by various microorganisms, which damage the tissues by different mechanisms. these infectious agents can be broadly classified into viruses, bacteria, fungi, protozoa, and helminths. amongst these five groups, viruses hold special significance due to their ability to manipulate the host-cell machinery in a unique manner and evolve continuously to thrive and survive in all species. nearing by the end of , a group of pneumonia cases occurred in wuhan, a city in the hubei province of china with the causative agent being identified as a novel coronavirus. it spread at a rapid pace in china culminating into an epidemic with widespread involvement of other countries across the globe. the world health organization (who) declared the outbreak as a 'public health emergency of international concern' on january, , and subsequently designated the disease as 'covid- ', which stands for coronavirus disease . the number of covid- cases in areas other than china increased multifold and the global burden of the disease rose to an alarming , cases in countries with a loss of , lives. this led who to ultimately declare covid- as a pandemic on march, . the cases are still increasing at an alarming rate involving a total of countries with , , confirmed cases and , reported deaths till april, . it is also designated as novel coronavirus acute respiratory disease or novel coronavirus pneumonia. this is the first ever pandemic to be initiated by a coronavirus and a situation of this gravitas has not been experienced by the world post the second world war (ww ii: - . the second world war with nearly million causalities including more than countries was undoubtedly the most dangerous event in human history. at that time, all the countries diligently utilized their entire scientific and economic capabilities in order to strengthen their position on the war front. mirroring this to the present scenario, all the countries must diagnose, isolate, provide treatment, locate, and mobilize the people to the maximum extent. this approach can prevent the conversion of a few cases into clusters and further limit the spread via community transmission. even countries with widespread involvement can turn the tide on this virus by coming together as one unit and effectively screening, isolating, and tracing all the possible cases. major events have been canceled, rescheduled, or modified to curb the transmission of this deadly disease. the grand slam tennis tournament at wimbledon scheduled for june- july, has been canceled for the first time since world war ii on april, . the tournament has been rescheduled between june and july, . another mega event, such as, the summer olympics to be held in tokyo has been postponed until pandemic as a word should be used cautiously and the intensity of using this word must be understood carefully. an inappropriate use of this word can either lead to undue fear or create a false impression of the fight being over. also, delineation of a situation as a pandemic should not alter the course of estimation of its danger and should strengthen the efforts to control the disease. the who propagates that in order to contain the spread and minimize the impact, every country must adopt a comprehensive approach involving both the governing bodies and the societies at large. viruses are miniature organisms which can multiply only inside a living cell. they contain nucleic acid, such as, rna or dna surrounded by a protein shell. viruses are generally classified by the organisms they infect including animals, plants, or bacteria. coronaviruses are single-stranded rna viruses surrounded by an envelope, belonging to the family coronaviridae. they mostly affect mammals including humans and birds. they possess unique crown-like projections on their surface which correspond to large spike proteins as seen on electron microscopy. coronaviruses have been classified into three groups based on serology and genetic characteristics with the human coronaviruses (hcovs) belonging to groups and . in humans, coronaviruses are implicated for causing common cold as well as more severe respiratory infections including both severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers). the world health organization (who) has classified novel coronavirus ( -ncov) as a beta-coronavirus (β cov) of group b belonging to subfamily orthocoronavirinae. the genetic attributes of the -ncov are highly identical to sars-cov and mers-cov with their source of origin being bats. another piece of evidence, which supports that -ncov is of bat origin, is the existence of a high degree of homology of the angiotensin converting enzyme- (ace- ) receptor amongst different species of animals causing them to either act as intermediate hosts or be utilized for research-oriented studies for -ncov infections. the epithelial cells of lungs have been hypothesized as the primary targets of -ncov. the first step of infection with the virus involves binding with a host-cell receptor and subsequent union with the host-cell membrane. thus, there is a strong evidence, which points toward human-to-human transmission of -ncov via binding between viral surface spike proteins and host ace- receptor. in wuhan city, the wet animal markets being a source of live animals were largely implicated for a high number of positive cases, strongly pointing at the zoonotic origin of -ncov. efforts were made to identify the reservoir host transmitting the infection to humans with preliminary evidence suggesting two species of snakes as possible reservoirs of -ncov. however, there is still a lack of concrete data, which identifies any coronavirus reservoir other than birds and mammals. the high degree of genetic similarity between -ncov and two sars-like coronaviruses indicates mammals as the mode of transmission of -ncov to humans. the cause of spread of -ncov infection has been identified as person-to-person transmission. , the basis of this observation lies with the fact that a large number of cases were identified among those families who had never visited wuhan's wet animal markets. direct contact with an infected individual and spread of infection via droplets either by sneezing or coughing are the two most important modes of person-to-person transmission. also, no definitive vaccine is yet available against the virus with trials underway for the same. coronavirus disease- (covid- ) was first seen in wuhan, china, in the end of and spread at an alarming speed to involve a large number of countries, culminating into a deadly pandemic. in december , a group of pneumonia cases of unknown cause was linked to a local seafood market in wuhan. following this, a total of five patients with acute respiratory distress syndrome were hospitalized from december, to december, with one reported fatality. as of april, , a total of , , cases of covid- have been reported in countries and territories, resulting in nearly , deaths. more than , people have recovered. the large variations in number of these cases are dependent upon their region of origin, time since initial outbreak, degree to which diagnostic tests are being conducted, healthcare infrastructure and services, treatment facilities, and various other population parameters. amongst the six who regions including the western pacific, european, south-east asia, eastern mediterranean region, region of the americas and african region, local transmission has been reported in several countries. in western pacific region, china reported highest number of cases ( , ) followed by south korea ( , ), australia ( , ), malaysia ( , ), and japan ( , ) . in european region, italy had highest cases ( , ) followed by spain ( , ), germany ( , ), france ( , ), uk ( , ), and switzerland ( , ) . iran had reported , cases followed by pakistan ( , ) and saudi arabia ( , ) in eastern mediterranean region. usa reported the highest cases ( , ) among the region of americas followed by canada ( , ), brazil ( , ), and chile. in african region, south africa reported , cases followed by algeria. in south-east asia, indonesia reported , cases followed by india ( , ), thailand ( , ), sri lanka ( ), bangladesh ( ), and maldives ( ). in india, first case was reported on january, in kerala. as of april, , there were approximately , cases among which recovered with casualties. maharashtra had reported the highest number of cases ( ) followed by kerala ( ), tamil nadu ( ), delhi ( ), and uttar pradesh ( ). the total number of confirmed covid- cases, deaths, and summary of cases among different countries till th of april, can be summarized as depicted in tables to , respectively. the increase in confirmed covid- cases and deaths among different countries till april, , has been depicted in figures and , respectively. the current covid- outbreak has created a major havoc amongst healthcare professionals, including dentists. since dental professionals perform procedures which create aerosols and are in direct contact with saliva and blood, the exposure risk is high among dentists. as a result, the entire dental team is highly vulnerable, facing a high possibility of direct exposure to the virus, which also implies a major negative psychological impact. due to this emergent outbreak and difficulty in screening the patient for covid- , dentists are mostly uncertain of encountering a positive patient. seasonal flu is common among children, and with the changing weather conditions, cold and cough have become extremely prevalent. these may present with overlapping signs and symptoms of covid- , complicating all elective dental procedures and provision of noncritical dental care. the centers for medicare and medicaid services (cms) recommend that all nonessential dental examinations and procedures must be postponed until further notice. since the announcement of a total lockdown in india on march, , a vast number of private and government dental colleges and hospitals along with private clinics have been completely shut so as to prevent the exposure. the indian dental association (ida) has recommended that all the private dental clinics must not perform any type of nonemergency dental care. the indian society of pedodontics and preventive dentistry (isppd) also issued an advisory for oral health professionals and pediatric dentists including c (clean, cover, and confine), o (observe, online, or telephonic consultation as possible), r (restrict to emergency treatment only and all elective treatment to be postponed as far as possible), o (obey), n (no aerosol), and a (avoid). the declarations issued by these various organizations prove the threatening nature of the current situation for dental professionals. with the closure of various private dental clinics, provision of essential services has become difficult with the dentists incurring economic losses of varying magnitudes. despite these guidelines, hospitals, such as, maulana azad institute of dental sciences, (maids) new delhi, centre for dental education and research (cder) aiims, new delhi, and dental department at ram manohar lohia hospital, new delhi along with various other hospitals across the country, still continue to provide emergency dental services to the needful. even in grave circumstances, such as, todays, a patient reporting with a dental emergency is being effectively treated by dental professionals at such hospitals. the covid- pandemic has continued to unfold dramatically all over the world, bringing us to the current state of an international emergency. the cases have seen an exponential rise and so has they have been continuously trying to reinforce the precautionary guidelines for all, time and again. to ensure everyone's safety and following the restrictions laid on travel and large gatherings, the scheduled international conferences have also been postponed. the dental practices have been limited to emergency services only and our entire dental fraternity has been challenged academically, professionally, and financially. to cope up with academic loss, continuous efforts are being made to provide high-quality educational content. social platforms are being used to conduct webinars in an effort to connect people all around the world with the experts, in various interactive learning sessions. surveys are being conducted to evaluate the stress and future implications of this pandemic on dental professionals in order to seek solutions to deal with it on a wide spectrum. efforts are being made by various dental organizations and societies to not connect 'physically' but 'digitally'. the current situation has created a severe negative psychological impact among dental professionals. though all precautionary measures are taken and no procedure is performed without the use of personal protective equipment (ppe), the risk of being exposed and carrying the infection to home is still a major concern. also, the limited availability of ppes is becoming a matter of great concern among health professionals largely restricting their capabilities for providing emergent health services. though the responsibilities are major and expectations are high, dental professionals are at the forefront to provide with whatever best they can! the covid- pandemic, caused by novel coronavirus, has caused a major disruption in the indian healthcare system including both medical and dental facilities. the risk of infection is particularly high among the dental professionals due to a variety of reasons. the covid- virus may spread through handpiece-generated aerosols, aerosols produced while using ultrasonic scalers, use of air/water syringes in different dental procedures, or via infected droplets through coughing and sneezing. this virus has a high tendency to survive on exposed environmental surfaces, such as, those found in dental offices for extended periods of time. also, it has been seen that asymptomatic individuals infected with the virus may shed the virus via various body secretions, such as, saliva and transmit the disease. the risk is even higher in pediatric dentistry as children may be asymptomatic but infectious posing a high risk not only to the dentist but also to the parents or guardians accompanying the patient. due to the impending danger of spreading the infection, various dental organizations, such as, american dental association (ada), american dental hygienists' association (adha), indian dental association (ida), indian society of pedodontics and preventive dentistry (isppd), and many others have advised the dental professionals to undertake only essential and urgent dental procedures. , , , present scenario it is important that the dental professionals must carefully weigh the risk associated with provision of nonessential treatment and emergency care to the needful against the availability of personal protective equipment (ppe) for limiting the transmission of infection. the ada, isppd, centers for disease control and prevention (cdc) and occupational safety and health administration (osha) have proposed various measures and guidelines for the safety of both the patients and dental professionals. , [ ] [ ] [ ] the following measures should be taken to minimize risk during dental treatment , - : • dentists should follow appropriate hand hygiene practices and proper usage of personal protective equipment (ppe). • while treating patients in close approximation to their respiratory system, usage of n masks, with proper sealing of areas around the nose and mouth, together with a full-face shield and goggles should be worn. • rinsing the oral cavity with . % povidone-iodine prior to any dental procedure can cause significant reduction in salivary viral load. • use of disposable mouth mirror, syringes, and blood pressure cuff to prevent cross contamination. • take extraoral radiographs whenever possible; intraoral techniques may induce coughing. • while taking intraoral radiographs, double barriers must be used for protection of sensors and to further limit the chances of cross infection. • use of hand instruments should be preferred over aerosolgenerating procedures and high-speed suction facility must be available. • use of dental dam must be encouraged during various dental procedures in order to limit splashing of saliva. also, covering the nose with rubber dam sheet can provide additional benefit to the patient. • dental treatment of patients with suspected or confirmed covid- disease must be carried out in negative pressure treatment rooms or airborne infection isolation rooms. • proper disinfection of all the inanimate surfaces must be carried out daily by mopping with a linen/absorbable cloth soaked in % sodium hypochlorite and must maintain a dry environment. during the active covid- crisis and lockdown period: • creating awareness among people regarding the disease, transmission, and protective measures to be taken (table ). • it is also essential to impart knowledge to them regarding the importance of social distancing. • in this crucial time, it is mandatory to make the patients understand what is dental emergency and to realize the pros and cons of providing unnecessary exposure. • screening for patients with dental emergencies with a history of contact. • using teledentistry in order to limit the spread of infection. • clean your hands often: • with soap and water for at least for seconds. • with sanitizer having % alcohol. • avoid touching your eyes, nose, and mouth with unwashed hands. • avoid close contact with people who are sick. • social distancing with other people due to asymptomatic cases (at least feet). • cover your mouth and nose with a cloth face cover when around others. • cover coughs and sneezes. • throw used tissues in the closed bin and immediately wash your hands. • clean and disinfect frequently touched surfaces daily by the following: • diluting household bleach. • alcohol solutions with at least % concentration. • other common epa-registered household disinfectants. if surfaces are dirty, clean them: use detergent or soap and water prior to disinfection. the cases of covid- seem to be rising at an alarming rate across the world. if the conditions continue to deteriorate, the healthcare professionals will have to face the grave challenge of balancing the treatment needs with the available workforce. in such circumstances, dental professionals with their basic knowledge of human body and vast usage of aseptic techniques can prove to be highly indispensable to the healthcare workforce. this will certainly provide an opportunity for the local hospitals facing the highest demand to utilize dentists' skills in the time of need. some of the ways dentists can provide their assistance may include: • primary screening of patients with history regarding symptoms of covid- . • recording the four primary vital signs, i.e., body temperature, blood pressure, heart rate, and respiratory rate. • performing diagnostic tests for covid- detection. • triaging to determine the priority of treatment. • providing emergency dental care. • oxygen administration along with provision of essential vaccinations. • writing prescriptions. • provision of services including deep sedation or general anesthesia along with intubations by dental anesthesiologists. • donating spare ppe, n , and surgical masks, face shields, gowns, gloves, and hand sanitizers to hospitals in order to meet the increased treatment demands. in this way, the dental healthcare professionals can accomplish their role as healthcare workers and help in serving the nation. the anticipated difficulties in the future can be rationally divided into immediate implications, which would be observed after completion of lockdown period and before the availability of a therapeutic drug or vaccine, and extended implications may be seen after the availability of a therapeutic drug or vaccine and hence emerge over an extended period of time thereafter. , anticipated immediate implications social front: even after india overcomes the disaster stage of the pandemic, the viral infection would still prevail and should not be overlooked. hence, preventive measures and use of safety equipment would be necessary till a potential vaccine or therapeutic drug is made to overpower the covid- virus. measures at the public front would include the following: , • wearing masks in public places • social distancing • good hygiene measures • continued screening for covid- at all potential places involving airports, railway stations, hotels, and hospitals. • limited social gatherings/conferences • limited international travel • immediate consultation on appearance of symptoms and quarantining the healthcare sector's active participation on following the current protocol for disease screening, evaluation, and treatment is necessary. measures adopted: , impacts on dental sector: • detailed past medical and traveling history should be taken from the patients with elaborated discussion on symptoms for the infection -continuing screening of patients. • all patients should be treated under universal precautions. • use of masks and personal protective equipment (ppe) while treating a patient should be mandatory. • patients with symptoms of covid- should be referred and elective dental treatment deferred till recovery. • minimizing aerosol production to avoid infection from asymptomatic patients. the present time is proving to be difficult for every strata of the society but it is expeditiously arduous for healthcare professionals design principles in virus particle construction world health organisation world health organization, director-general's opening remarks at the media briefing on covid- - world health organization, coronavirus disease (covid- ) pandemic. world health organisation coronavirus pathogenesis symmetry in virus architecture origin and evolution of pathogenic coronaviruses receptor recognition by the novel coronavirus from wuhan: an analysis based on decade-long structural studies of sars coronavirus a novel coronavirus from patients with pneumonia in china coronavirus update (live) available from: www.worldometers.info/ coronavirus situation report - . world health organisation ministry of health and family welfare ada recommending dentists postpone elective procedures. american dental association. [last accessed on adha covid- updates for dental hygienists. american dental hygienists' association. [last accessed on cms adult elective surgery and procedures recommendations. centers for medicare and medicaid services. [last accessed on advisory by isppd head office to all the oral health professioanls & pediatric dentists. indian society of pedodontics and preventive dentistry summary of ada guidance during the covid- crisis interim infection prevention and control guidance for dental settings during the covid- response preparedness and lessons learned from the novel coronavirus disease the sars, mers and novel coronavirus (covid- ) epidemics, the newest and biggest global health threats: what lessons have we learned? international journal of clinical pediatric dentistry, volume issue (may-june ) including dental personnel. although all the necessary precautions are being diligently followed at various dental hospitals, providing services even to most needful has become a tedious expedition. with so much uncertainty and peculiarly precarious nature of the present situation, we can only hope to contribute in the best of our capabilities without overlooking the need for adopting all the necessary steps to prevent and limit the spread of this deadly disease at large. key: cord- -l icku i authors: olaoye, omotayo; tuck, chloe; khor, wei ping; mcmenamin, roisin; hudson, luke; northall, mike; panford-quainoo, edwin; asima, derrick mawuena; ashiru-oredope, diane title: improving access to antimicrobial prescribing guidelines in african countries: development and pilot implementation of an app and cross-sectional assessment of attitudes and behaviour survey of healthcare workers and patients date: - - journal: antibiotics (basel) doi: . /antibiotics sha: doc_id: cord_uid: l icku i smartphone apps have proven to be an effective and acceptable resource for accessing information on antimicrobial prescribing. the purpose of the study is to highlight the development and implementation of a smartphone/mobile app (app) for antimicrobial prescribing guidelines (the commonwealth partnerships for antimicrobial stewardship—cwpams app) in ghana, tanzania, uganda and zambia and to evaluate patients’ and healthcare providers’ perspectives on the use of the app in one of the participating institutions. two structured cross-sectional questionnaires containing likert scale, multiple-choice, and open-ended questions were issued to patients and healthcare workers six months after the introduction of the app at one of the hospital sites. metrics of the use of the app for a one-year period were also obtained. download and use of the app peaked between september and november with pharmacists accounting for the profession that the most frequently accessed the app. more than half of the responding patients had a positive attitude to the use of the app by health professionals. results also revealed that more than % of health care workers who had used the cwpams app were comfortable using a smartphone/mobile device on a ward round, considered the app very useful, and found it to improve their awareness of antimicrobial stewardship, including documentation of the indication and duration for antimicrobials on the drug chart. it also encouraged pharmacists and nurses to challenge inappropriate antimicrobial prescribing. overall, our findings suggest that its use as a guide to antimicrobial prescribing sparked positive responses from patients and health professionals. further studies will be useful in identifying the long-term consequences of the use of the cwpams app and scope to implement in other settings, in order to guide future innovations and wider use. antimicrobial stewardship programs in hospitals are focused on optimising antimicrobial prescribing to improve individual patient care, decrease healthcare costs and combat antimicrobial resistance [ ] . the availability of accurate and up-to-date information is important to guide the right diagnosis and prescription of antimicrobials. healthcare providers' attempts to access this information are influenced by previous training, availability of the information, ability to access and leverage technology [ ] . there has been a recent rise in the use of smartphones generally across global population and it is predicted to be rising fastest in africa. there has been increased development of smartphone apps designed for use in healthcare, including in the area of antimicrobial stewardship [ ] [ ] [ ] [ ] [ ] . current research in medicine has shown that the use of mobile phones and devices in medical settings is more popular and is increasingly being brought to the fore of international research [ ] . for instance, recent studies have shown that % of smartphone users access medical information through their devices [ ] . a study by kamerow, chief scientist and associate editor for the british medical journal, revealed that there are approximately , health-oriented smartphone apps and, by the year , over million smartphone owners worldwide will use these apps [ ] . the study also highlighted that, although designed for health professionals, around % of health apps are now marketed to patients to help them monitor, evaluate, and transmit medical data such as blood pressure and body weight among other health checks [ ] . the author also stated that the use of these apps was higher amongst the younger population, females, and people who earned a higher income. similarly, results from a longitudinal study of medical doctors working at hannover medical school, germany in the summer of and spring of also revealed a rapid increase in the use of mobile devices in medical settings during patient interaction and professional collaboration [ ] . this significant increase was observed in both the frequency of use and the expansion of the areas of application of these devices. smartphones have specific features that support their increasing use in healthcare delivery and behavioural interventions. they are highly portable, more convenient, cost-effective and interconnected compared to reference books and computers, thus promoting improved communication and the sharing of knowledge, data and resources among health professionals and as well as facilitating regular updates as new data becomes available [ ] [ ] [ ] . furthermore, the ability of smartphones to use internal sensors to deduce context including emotions, location and activity has greatly increased their relevance in the consistent monitoring and tracking of health-related behaviours and healthcare delivery [ ] [ ] [ ] [ ] [ ] [ ] . in the early days of their use, there was a significant paucity of academic research on users' viewpoints and experiences with the use of these apps. the recent literature has provided positive feedback on the acceptability and workability of smartphone apps although it has also been recognized that this evolving technology may raise concerns regarding privacy and security [ , ] . in the past decade, there has been a rapid increase in the use of mobile phones in africa [ ] . there has also been a rapid integration of mobile health technologies and telecommunication into the healthcare system, especially in low and middle-income countries. in addition to this there has been an increased investment in mobile healthcare interventions including the use of these technologies for behavioural change communication [ ] . with the increasing burden of communicable and non-communicable diseases in africa, low-cost mobile health technology has the potential to make healthcare more accessible to disadvantaged communities [ ] . for example, in zambia and ghana adverse event reporting apps were developed by medical regulatory authorities in [ ] . the zambia medicines regulatory authority-zamra also launched adverse drug reaction application (adra), a new mobile application for android phone users for reporting adverse medicines reactions in [ ] . furthermore, apps have been used to identify falsified and substandard medicines in kenya [ ] . these technologies also offer great solutions aimed at improving the speed, safety and quality of healthcare provision in resource-constrained settings by providing easy access to local and international guidelines and resources. the purpose of the study is to highlight the development and implementation of an app to support prudent antimicrobial prescribing and improved antimicrobial stewardship practice; as part of the commonwealth partnerships for antimicrobial stewardship (cwpams) programme in ghana, tanzania, uganda and zambia and to conduct a pilot antibiotics , , of study assessing patients and healthcare providers' perspectives on the use of the app in one of the hospitals in ghana. the commonwealth partnerships for antimicrobial stewardship app was developed to improve antimicrobial prescribing and stewardship practices among health professionals in ghana, tanzania, uganda and zambia. the app provides, for the first time in the four countries, easy access to infection management resources to improve appropriate use of antimicrobials in line with national and international guidelines. following the launch of the app in four countries, there were downloads of the app and , guide opens within months. ghana had more page hits ( . %) than uganda ( %), tanzania ( %), zambia ( . %) and others ( . %) ( table ). the most visited section of the app was the national prescribing guidelines, accounting for . % of the total number of page hits while the section for updates on antimicrobial resistance (amr) (coming soon) was the least visited ( . %). pharmacists ( . %) and nurses ( . %) accounted for the highest number of registered users while pharmacists ( . %) and medical doctors ( . %) had the highest frequency of downloads and guide opens ( table ). a cross-sectional attitude and behaviour survey was carried out on patients and healthcare professionals to determine their attitudes/views on the use of antimicrobial prescribing guidelines by health professionals. a total of patients and health professionals participated in the survey; response rates were % and %, respectively. demographics presented in table shows that respondents comprise various age groups and educational qualifications and professions. patients' views on the use of the app by health professionals obtained using a likert scale of five options (strongly agree, agree, neutral, disagree and strongly disagree) are presented in table . more than % of patients had a positive attitude to the use of smartphone apps by health professionals and the fact that it increases the quality of healthcare offered by health professionals and quickens access to healthcare. patients' greatest concern was that the use of smart phone mobile apps in healthcare delivery could be a distraction to healthcare provision. this was followed by concerns that their data may not be protected/secure and that mobile devices may not be technically reliable enough. patients' least concern was that the health professional "may not be competent enough". the highest proportion of patients who had no concerns with their use of smartphone apps by health professionals were aged - ( . %). this was followed by patients aged and above ( . %), - ( . %), - ( . %) and - ( . %) in descending order. patients aged - had concerns with health professionals' use of smartphone apps. patients with the most concern with health professionals' use of smartphones were aged - . with respect to patients' highest level of education, patients with tertiary education ( . % had the least concern with health professionals' use of smartphone apps while patients with basic primary education ( %) had the most concern. patients' preferences for health professionals' use to access medicines information the highest proportion of patients wanted health professionals to use a computer or laptop ( . %). this was followed by smartphone mobile apps ( . %), reference books ( . %) and tablets ( . %) in descending order. a computer/laptop/reference book was preferred by . % of patients while . % preferred any of a smartphone, computer/laptop or tablet, a smartphone, computer/laptop or reference book, a smartphone or tablet, and a computer/laptop, reference book or tablet. additionally, . % of patients had no preference (n = ). thirty-eight healthcare workers (hcws) comprising of four doctors, eighteen nurses, six pharmacists and ten other healthcare workers participated in the survey. on a daily basis, mobile phones ( . %) and printed posters ( . %) were most predominantly used by the hcws, while tablets and computers ( . % each) were the least used devices (table ). mobile phones were used more than once a day by . % of healthcare workers. percentages of healthcare workers antibiotics , , of who had never used a tablet, pocketbook, printed posters and computers were . %, . %, . % and . %, respectively. healthcare workers' responses showed that many respondents had not consulted the cwpams app for antimicrobial prescribing information. the british national formulary (bnf)/national guidelines, a printed copy of standard treatment guidelines, senior colleagues and junior doctors were mostly consulted daily. in descending order, internet search engines, senior colleagues and pharmacists were consulted more than once a day. no additional source of information on antimicrobial prescribing was mentioned. an assessment of the various sources of information on antimicrobial prescribing used by healthcare workers showed that the cwpams app was mostly used by nurses and other health workers. bnf and national guidelines were mostly used by doctors ( %) and pharmacists ( . %) and least used by nurses ( . %). internet search engines were mostly used by pharmacists ( %) and least used by doctors ( %) (see figure ). pharmacists were seen to refer to their senior colleagues for antibiotic information more than doctors, nurses and other health professionals. more doctors and other healthcare workers (midwives, dispensing technicians and medication counter assistants) sought information from pharmacists than nurses. printed copies of the standard treatment guidelines were mostly used by pharmacists and least used by nurses. assistants) sought information from pharmacists than nurses. printed copies of the standard treatment guidelines were mostly used by pharmacists and least used by nurses. all responding healthcare practitioners admitted being concerned about the emergence of drug resistant infections while . % agreed or strongly agreed that these guidelines are easy to access. a total of . % stated that they preferred their senior's preferences over standard treatment guidelines. only . % preferred to use non-standard treatment guidelines for antimicrobial prescribing while . % felt the standard treatment guidelines did not apply to their patients (table ). all responding healthcare practitioners admitted being concerned about the emergence of drug resistant infections while . % agreed or strongly agreed that these guidelines are easy to access. a total of . % stated that they preferred their senior's preferences over standard treatment guidelines. only . % preferred to use non-standard treatment guidelines for antimicrobial prescribing while . % felt the standard treatment guidelines did not apply to their patients (table ). perception and assessment of the cwpams smartphone app all healthcare workers who had used the app agreed that the app was very useful, relevant to their patient population and considered it the best way to access standard antimicrobial treatment guidelines. in addition, they all felt comfortable using a smartphone on a ward round, admitting that the app increased their awareness of antimicrobial stewardship and encouraged them to challenge antibiotics , , of inappropriate prescribing and to document the indication and duration for antimicrobials on the drug chart. furthermore, participants found the country-specific standard treatment guidelines most useful. this was followed by the who essential medicines list section and the antimicrobial stewardship (ams) resource section. analysis of the cwpams app metrics revealed that the months with the highest downloads and page hits were september, october and november. the increase in september and october can be largely attributed to partnership project visits and antimicrobial stewardship interventions in all four countries. the spike in the month of november can most likely be linked to events during the world antibiotic awareness week in all four countries as well as the app promotion by the commonwealth pharmacists association during the world antibiotic awareness week. pharmacists accounted for the highest number of registered users and had more page hits and downloads than other health care professionals and workers. while this could mean that the app is more common among pharmacy teams, it calls for increased app promotion among doctors and other health professionals, who have also begun to use the app. the variations in the number of page hits and app downloads in each country can be explained by the number of partnerships in per country as ghana and uganda had the highest number of partnerships while tanzania and zambia had the lowest number of partnerships. the use of smartphone mobile apps in healthcare delivery has gained acceptance over the years among patients and health professionals in sub-saharan africa and worldwide [ ] . the cwpams app was developed by the commonwealth pharmacists association to provide easy access to medicine management information for health professionals across ghana, tanzania, uganda and zambia. in addition to providing health professionals with relevant national and international guidelines, notable advantages of the app are its usability without internet access, a feature which suits low and middle-income countries, and its easy adaptability. most recently, the app was updated to provide health care professionals across the commonwealth with links to relevant country-specific and international resources on covid- from the world health organization (who), international pharmaceutical federation (fip) and the africa centres for disease control and prevention, among other relevant sources. the pilot study showed that more than % of patients were content with their health professional's use of smartphone apps while attending to them. age and education level had an impact on the patient's acceptance of smartphone mobile technology as middle-aged patients had the least acceptance while the young and the most elderly had the greatest acceptance. patients with tertiary education had the highest acceptance for these technologies while those with basic primary education had the least acceptance. these results correlate with a study carried out in on the acceptance and use of health technology by community-dwelling elders which revealed that income, education and age were found to significantly affect the acceptance of technology in healthcare. patients with higher education and income used the internet at rates close to or exceeding the general population [ ] . another study also revealed that the acceptance of mobile phone technology among the older population was on the increase as they were found to constitute the fastest-growing group using the internet and computers [ ] . regarding patients' preferences, our survey reveals that more patients preferred their health professionals using a computer/laptop to access information over a smartphone or reference book. this can be explained by the fact that the patients' greatest concern was that smartphones could be a distraction to healthcare provision. this concern corroborates findings from a study by wu et al. which revealed that on an average, physicians' smartphones received . emails and . telephone calls, sent out . emails and initiated . telephone calls within h. the study also revealed that . % of perfusionists admitted that they had used a cellular phone for purposes other than healthcare delivery while performing their duties [ ] . on the contrary, a cross-sectional survey of adult patients in metropolitan academic and private dermatological clinics carried out in revealed that most patients ( . %) considered personal smartphones an acceptable reference tool to provide information in patient care [ ] . to access medical information more than once a day, health care workers mostly use mobile phones ( . %) and printed posters ( . %). these sources were also the most predominantly used daily ( . % and . %), respectively. this supports previous studies which have highlighted an increase in the use of smartphone mobile apps by health professionals [ ] [ ] [ ] . healthcare workers were also found to mostly consult internet search engines ( %), senior colleagues ( . %) and pharmacists ( . %) to access antibiotic prescribing information more than once a day. this demonstrates the need to involve these groups in promoting the app as they have a significant influence on antibiotic prescribing behaviours and healthcare workers' decisions. furthermore, healthcare professionals' responses to the use of the cwpams app was found to correspond with results obtained from a similar study by panesar et al. involving healthcare professionals. both studies show that the health professionals found apps useful and relevant to their patient population. they also agreed that apps encouraged them to challenge inappropriate prescribing [ ] . the concern displayed by healthcare workers for the emergence of drug-resistant infections and the use of the standard treatment guidelines as seen in table was highly impressive. healthcare workers also found the country-specific section of the cwpams app most useful. this correlates with the app metrics from all four countries which revealed that the national prescribing guidelines had the highest number of page hits from may to may . the study highlights the need for more healthcare workers, especially doctors, to use the cwpams app as app metrics and the pilot cross-sectional survey both reveal that more nurses and pharmacists than doctors had used the app. there is also the need for more focused implementation as well as app promotion at all partnership sites and among all health professionals, especially doctors who are prescribers. furthermore, there may be a need for subsequent studies to be carried out within the hospital when a higher number of healthcare professionals have used the app, in order to have a broader perspective from patients and health professionals. it would also be important to incorporate regular reminders about the app into the implementation strategy. a recently published study by lester et al. [ ] highlighted that implementing a locally appropriate, pragmatic antibiotic guideline through an app, supported by a simple educational strategy of weekly 'reminders', led to a significant reduction in third generation cephalosporin usage as well as an increase in the proportion of -h antibiotic reviews. the cwpams microguide antimicrobial prescribing app is the first of its kind to combine country-specific and international guidelines and information on antimicrobial prescribing for ghana, tanzania, uganda and zambia. hence, based on our knowledge, this study on the development, implementation and use of the app in these four countries is novel. one of the limitations is the low sample size for the surveys, which was due to the time constraint in carrying out the survey, limited time spent by patients at the waiting room of a single hospital site and health care workers' busy schedules. however, it is important to note that this section of the full study was intended to be a pilot in one setting and to provide initial descriptive findings. extensive surveying across other sites would enable a test of significance and to confirm trends. in addition, the survey encompassed a wide range of health care workers, including doctors, pharmacists, nurses, midwives and other health care workers. patients' who participated where across a broad range with respect to age and education, providing a wide perspective. the response rate was greater for patients than health professionals, most likely because patients were available to fill questionnaires whilst in waiting rooms compared to health professionals. the proportion of healthcare workers groups that responded to the survey were not comparable. this is due to more nurses and other health care workers being available in the hospital compared to doctors and pharmacists. though not all healthcare workers had used the app, there was an . % response rate from those who had used the app to questions on the use of the app. frequent updates and increased use of the app by health care workers highlight the need for further studies. the cwpams app was developed by the commonwealth pharmacists association using the microguide platform (http://www.microguide.eu). the platform provides a cloud-based service that allows local pharmacists to develop, manage, update and publish clinical guidelines to various apps for any mobile operating system including ios (apple, cupertino, ca, usa), android (google, mountain view, ca, usa), windows devices (microsoft, redmond, wa, usa) among other operating systems. it offers healthcare professionals offline access to clinical guidelines and content autonomously managed by pharmacy teams. it is also available online via https://viewer.microguide.global/cpa/cwpams. the cwpams app contains national and international guidelines listed into various sections including the who essential medicines list, surveillance tools, antimicrobial stewardship training, infection prevention and control (ipc) resources, and country-specific standard treatment guidelines. the app metrics and statistics were derived from routine data collection by horizon strategic partners. the cwpams app was developed for use by secondary care institutions that were part of the cwpams programme in four countries ghana, tanzania, uganda and zambia (s -s , video s ). one of the hospitals in the partnership was used as the pilot study site. the hospital is a secondary health facility with a -bed capacity. cwpams is a health partnership programme funded by the uk department of health and social care's fleming fund to tackle antimicrobial resistance (amr) globally. cwpams will support partnerships between the uk nhs and institutions in ghana, tanzania, uganda and zambia to work together on ams initiatives. this aims to enhance implementation of protocols and evidenced based decision making to support antimicrobial prescribing, as well as capacity for antimicrobial surveillance. further information about cwpams is available via https://commonwealthpharmacy. org/commonwealth-partnerships-for-antimicrobial-stewardship/. cwpams is being run by the commonwealth pharmacists association (cpa) and tropical health education trust (thet). the cwpams app metrics were obtained from data collected by the horizon strategic partners. these assessed the frequency of page hits, guide opens and the number of registered users and downloads. the pilot study was a cross-sectional survey with patients and healthcare workers in one of the hospital sites, six months after the introduction of the app using questionnaires adapted from panesar et al. [ ] . patients' questionnaires comprised of four sections with eight questions using a likert scale and multiple-choice questions. the first section comprised of demographics including age, gender, highest education qualification and occupation. the second section assessed patients' attitudes to health professionals' use of smart phone mobile apps in healthcare delivery. the third section was designed to obtain patients' concerns about the use of these smart phone apps, while the last section requested patients' preferences for health professionals reference ranging from a smart phone mobile app to a tablet, computer/laptop and a reference book. the health care workers' questionnaires comprised of nine sections with questions designed as a likert scale and open-ended questions. the first section obtained healthcare workers' demographics including country, specialty, year of graduation, grade, type of institution and profession and role. the eight sections following comprised of health professionals' attitudes to the use of the cwpams app and current practices. a convenience sample size determination of maximum each was used for the cross-sectional study. app metrics for user engagement evaluating the number of registered users, downloads, guide opens and page hits for various sections of the app from april to may were obtained through the microguide platform. (http://www.microguide.eu). health professionals survey: questionnaires were distributed among healthcare workers comprising of doctors, pharmacists, nurses and other healthcare workers at various points of care in the hospital including consulting rooms, nurses' station, pharmacy sections and wards. a total of questionnaires were distributed to health professionals with returned questionnaires completed anonymously. patients survey: patients' questionnaires were distributed to patients in the waiting room within the consulting area. patients' questionnaires comprised of demographic data and questions regarding attitude to the use of smartphone apps among health professionals over a one-week period. patients' consent was sought for before administration of the questionnaires. a total of questionnaires were distributed to patients based on patients available in hospital during the study period. all questionnaires (s : questionnaires) were completed anonymously with no personally identifiable information documented. study was conducted under service improvement as part of the cwpams project therefore no ethical approval was required but the ghana health service and the ghana amr platform were made aware of the pilot project. microsoft excel was used to analyse the data obtained from the pilot study using descriptive statistics. our study provides insight into the overall perception of the use of mobile apps as a means to improve antimicrobial stewardship, demonstrating general acceptance among patients and healthcare professionals. in general, the patients and healthcare workers surveyed had a positive attitude following the introduction of the cwpams app as a fundamental resource for accessing information on antimicrobial prescribing. hence, increased and more comprehensive use of all sections of the app could contribute to improved antimicrobial stewardship practices among healthcare workers and increased acceptance of the use of smartphone apps among patients. app downloads and utilization were found to be highest during partnership visits and app promotion, highlighting the need for more focused implementation and promotion of the app among all health professionals, especially doctors. further studies will be useful in evaluating the impact of the app on antimicrobial prescribing as well as guide future antimicrobial stewardship interventions. supplementary materials: the following are available online at http://www.mdpi.com/ - / / / /s : s : launch communications presentation, s : ams app-commonwealth pharmacists association (cpa) press release https://commonwealthpharmacy.org/ams-app-cpa-press-release/, video s : commonwealth partnerships for antimicrobial stewardship app https://www.youtube.com/watch?v=mj fa_algci, s : app launch posters, s : questionnaires healthcare workers and patients. antimicrobial stewardship programs in health care systems how primary healthcare workers obtain information during consultations to aid safe prescribing in low-income and lower middle-income countries: a systematic review a mixed methods pilot study to investigate the impact of a hospital-specific iphone application (itreat) within a british junior doctor cohort attitudes and behaviours to antimicrobial prescribing following introduction of a smartphone app medical students and personal smartphones in the clinical environment: the impact on confidentiality of personal health information and professionalism mobile health regulating medical apps: which ones and how much? professional use of mobile devices at a university medical center mobile, social, and wearable computing and the evolution of psychological practice health and the mobile phone therapeutic applications of the mobile phone bewell: a smartphone application to monitor, model and promote wellbeing mobile sensing for mass-scale behavioural intervention emotionsense: a mobile phones based adaptive platform for experimental social psychology research the potential of internet-delivered behaviour change interventions mhealth in africa: challenges and opportunities effectiveness of mhealth behavior change communication interventions in developing countries: a systematic review of the literature mobile phone-based behavioural interventions for health: a systematic review the economics of ehealth and mhealth updates-fda launches med safety app to improve health care delivery in ghana together we unite: the role of the commonwealth in achieving universal health coverage through pharmaceutical care amidst the covid- pandemic recent news-kenya's e-health department has begun piloting a system to curb fake goods older adults and technology use computer use by older adults: a multi-disciplinary review an evaluation of the use of smartphones to communicate between clinicians: a mixed-methods study patient perception on the usage of smartphones for medical photography and for reference in dermatology sustained reduction in third-generation cephalosporin usage in adult inpatients following introduction of an antimicrobial stewardship program in a large urban hospital in malawi this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license the funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. mk and lh work at horizon strategic partners who own and manage the microguide app. key: cord- -jwweg f authors: abebe, ayele; mekuria, abinet; balchut, awraris title: awareness of health professionals on covid- and factors affecting it before and during index case in north shoa zone, ethiopia, date: - - journal: infect drug resist doi: . /idr.s sha: doc_id: cord_uid: jwweg f background: covid- is a disease caused by a sars-cov . the main way of transmission is from person to person through droplet nuclei. in this time, this disease has no treatment and vaccination. hence, the who recommends countries to work intensively on prevention and control measures. objective: this study aimed to assess the level of awareness on clinical and epidemiological spectrum of covid- and factors affecting it in the north shoa zone, amhara regional state, ethiopia, . methods: a facility-based cross-sectional study design was used to assess awareness of health professionals on covid- and associated factors affecting it before and during index case. a total of participants selected from hospitals participated in this study. the data were entered and coded using epi-info version . . and then transferred to spss version for analysis. bivariable and multivariable logistic regression were computed. variables with a p-value less than . were taken as predictor variables. results: a total of respondents with a response rate of % participated in this study. the proportion of participants with an awareness of covid- was ( . %). the types of profession (aor= . , % ci= . – . ) and level of a profession (aor= . , % ci= . – . ) of the profession, availability of television at home (aor= . , % ci= . , . ) and hearing of the emerging diseases in the past (aor= . , % ci= . – ) were factors that determine the awareness of health professionals on covid- clinical and epidemiological spectrum. conclusion and recommendations: the level of the health professional’s awareness on the clinical and epidemiological spectrum of covid- was promising. there is a need for a coordinated effort from stakeholders and health professionals to increase awareness. covid- is a disease caused by a new strain of the coronavirus, sars cov- . [ ] [ ] [ ] coronaviruses have the potential to cause severe transmissible human disease. coronaviruses cause illness ranging from the common cold to more severe diseases respiratory tracts. the known transmission routes for coronaviruses include sustained human-tohuman transmission via respiratory, by touching a contaminated surface or objects. one of the challenges of covid- outbreaks is that it is difficult to differentiate from other respiratory illnesses. covid- affects all people especially older age, with chronic medical conditions, such as diabetes and heart disease were at a greater risk of developing severe symptoms. since december and as of april , globally cases of covid- have been reported, including deaths. in africa, , covid- cases and deaths were reported since april , . african countries with the highest estimated numbers of covid- cases were south africa, egypt, morocco, algeria, and cameroon. ethiopia reported covid- cases and deaths with cases in these days as of april , . the covid- has effect on the entire world economy including africa. examples of this include tourism, air transport, and the oil sector. based on africa centers for disease control and prevention (africa cdc), african countries have reported covid- cases so far. the incidence of both infectious and non-communicable diseases such as chronic obstructive pulmonary disease (copd) or asthma is high in africa which is most vulnerable to the coronavirus, for whom the virus is often fatal. ethiopia confirmed the first case of covid- on march , . ethiopia reported a total of covid_ cases and deaths with cases in these days as of april , . pandemic and newly emerging infectious diseases strike developing countries including ethiopia beyond the health system. to prevent and control newly emerging infectious diseases including covid- ; there was a need for increased awareness, skill, and attitude of a health professional. as covid- was a newly emerging pandemic disease globally, assessment of the health professionals' awareness towards clinical and epidemiological spectrum and factors influencing it was a very important agenda. many covid- cases fully had recovery. but minority of its cases had been developed acute respiratory distress syndrome (ards), multiple organ failure, and sometimes death. the ratio of case-fatality is currently unknown but is estimated to be within the range of . - %. the impact of covid- to all human beings is inevitable. for example, the proportions of hypertension, cardio-cerebrovascular disease, and diabetes patient with covid- were . %, . %, and . %, respectively. the incidences of hypertension, cardio-cerebrovascular diseases, and diabetes were about twofold upper in health care facilities. , the covid- virus has many dimensional negative impact on the world. , the most common symptoms were fever and cough. most cases have mild disease and % cases progress to severe respiratory diseases, and in some cases death. , , currently, the diagnosis of covid- is based on gene detection via real-time rt-pcr. with the isolation of the causative agent, the development of serological tests and rapid diagnostic tests in addition to virus detection will be required. in addition to the pcr test, x-ray and ctimages can be used as a suggestive diagnostic modality. on the other hand, scientists around the world are actively exploring drugs but efficacy and safety of these candidate drugs in the treatment of covid- need to be confirmed in further preclinical and clinical trials. still, there is no drug treatment or vaccine for this disease except supportive care. once an individual gets sick with covid- , cdc recommends staying home, separate himself from other people, wear a facemask, avoid sharing personal household items and monitor symptoms. [ ] [ ] [ ] in most scenarios, highly effective contact tracing and case isolation are best for the prevention and control of covid- . therefore, isolation and contact tracing decreased transmission by a decrease in the effective reproduction number. the hospitals were also safeguarded by their staff who care for patients and monitoring them for signs or symptoms of infection. hence, support is provided to the morale and well-being of the workforce. the experience of hangzhou on the prevention and control of covid- showed that awareness creation, contact minimization, and travel restriction were the most pertinent measures for its prevention and control. different countries were following potential policies towards covid- prevention and control with regards to patients, visitors, and health care workers. these were screening all visitors for any respiratory symptoms, restricting health care workers from working if they have any upper respiratory tract symptoms and screening all patients with signs and symptoms. [ ] [ ] [ ] in some countries, work from the home arrangement for some employee was also made due to the covid- related closure. the effect of covid- on developing countries is in all aspects of the globe people. this negative impact covid- is very high in african country including ethiopia. so, this study was aimed to assess the level of awareness (clinical and epidemiological spectrum) and factors related to it among health care professionals, north shoa zone, ethiopia. a facility-based cross-sectional study was carried out to identify the level of awareness (clinical and epidemiological spectrum) of covid- and factors affecting it among health professionals at governmental public health hospitals in the north shoa zone, ethiopia. the study was conducted in north shoa zone, amhara regional state. this zone is found in the amhara national regional state. a study has been conducted from march - / . the zone has located km from addis ababa. regarding the health facilities there are public hospitals from which primary public hospital and one referral hospital, there are health centers, health posts in the zone. health professionals who worked in north shoa zone government hospitals. health professionals who worked in north shoa zone government hospitals. all health professionals who were working in the selected hospitals with a professional level of the diploma and above included in this study. health professionals who were unable to talk, seriously ill, and recruited less than six months of duration were excluded from this study. the sample size was calculated using a single population proportion formula as follows with a % confidence level, and marginal of error %. n = z(α/ ) p ( -p)/d where n = minimum sample size; z(α/ ) = % confidence level; p = proportion of awareness of covid- among health professional in which p= % since there is no previous study; d= % margin of error. in which n=[( . ) ( . )( - . )]/( . ) = adding % non-response rate; n= . a total of hospitals were found in the north shoa zone, of which are district hospitals, and one is referral hospital. as the two district hospitals started to provide the service recently and a few staff available (molle and mida hospital), not included in the study. the remaining hospitals were included in the study and a proportional to size allocation was used to collect the data ( figure ). a structured questionnaire prepared in english and then translated to amharic and back to english to maintain tool consistency. seven physicians and one bsc nurse were assigned as data collectors and supervised by the principal. the data collection tool was pre-tested in private hospitals with a similar setup to sort out language barriers and contextual differences. hence, any ambiguity in the questionnaires was corrected for the final data collection. questionnaires were checked and pre-test in a private hospital on % of participants. principal investigators were checked for consistency and completeness to maintain the quality of data. also, one-day training on data collection techniques and briefing of the questioners were made by the principal investigators. data were entered, coded, and cleaned by using epi-info version . . software, and then the cleaned data were exported to spss version software for analysis. descriptive analysis (text, percent, mean and median) was used to describe the study population concerning relevant variables. variable having a p-value less than . with bivariable analysis were transferred into the multivariable analysis. variables with a p-value of less than . in the final model were considered as statistically significant. levels of the association were reported using aor and a % confidence interval. covid- awareness -health professional was considered aware of covid- in its different spectrum if they score the mean value and above from questions. a spectrum of covid- -the spectrum of covid- refers to knowing the epidemiology, risk factor, sign and symptom, diagnostic approach, management, majority ( . %) of the participants had a television at home while ( . %) had a radio. about % ( ) of the participants had a smartphone and three-fourth ( ) of them did have a habit of searching health-related information via the internet. with regard to the institution, only ( . %) of the health professionals reported that their institution avail television to their department. the majority of the respondents, ( . %) mentioned that their institution had internet access. only ( . %) of the health professionals reported as their institution has a seminar on emerging diseases (table ) . the proportion of participants who were aware of covid- in this study was ( . %). among the health professionals, who heard of emerging disease, heard about covid- , and said covid- affects mainly respiratory system were ( . %), ( . %) and ( . %) respectively. fever ( ( . %)), cough ( ( . %)), and shortness of breath ( ( . %)) were the most common mentioned sign and symptoms of covid- and have vaccination, respectively. direct contact was the most common mode of transmission for covid- mentioned by health professionals (table ) . one hundred ( %) of the participants were explained that isolation was one of the early recognized measures of covid- while ( . %) were health promotion (figure ). the major reason ( . %) rose by the respondents for a suspect patient with the coronavirus infection were travel to an epidemic country with fever and travel to china with fever ( figure ). vaccination of cases, hand washing and using face mask were among the most common prevention, and control methods mentioned by the health professionals, north shoa one, (n= ) (figure ). the association between different independent variables and health professionals' awareness of covid- was assessed using a binary logistic regression model. accordingly, working health institutions, types of profession, level of the profession, availability of television at home, availability of television in the department of the working institution, and hearing about emerging diseases in the past have a significant association with health professional awareness in crude odds' ratio. to determine the independent effect of variables on health professional awareness, multiple logistic regression analysis was done. here in multi-variable analysis working health institutions, types of profession, level of the profession, availability of television at home, and hearing of the emerging diseases in the past had a significant association with an awareness of health professionals on covid- at % ci (table ) . regarding the working health institution, ( . %) of debre berhan referral hospital was aware of covid- . about ( %) of nurses were aware of covid- . midwife health professionals were about times more likely to be aware of covid- than that of laboratory (aor= . , % ci= . - . ) . regarding the level of the profession, % of the study participants who were aware had degree level of education. health professionals with a degree level of education were two times more likely to be aware than that of a diploma level (aor= . , % ci= . - . ) . (table ) more than half of the respondents ( . %) who had a television at their home were aware of covid- . health professionals who had a television at home were two times more aware of covid- than their counterparts. similarly, health professionals who had heard about emerging diseases were , times more likely to be aware of covid- than who did not hear (aor= . , % ci= . . (table ) according to this study, the proportion of participants who were aware of covid- was ( . %) while according to the who recommendations, health professionals were expected to be aware and competent in medical screening and management, including health monitoring. the possible reason for % of health professionals not to be aware might be the data were collected before covid- cases reported in ethiopia. among the health professionals, heard about covid- and said covid- affects mainly respiratory system was ( . %) and ( . %) respectively. this in case of sign and symptom; fever ( . %), cough ( . %) and shortness of breath ( . %) were the most common mentioned sign and symptoms of covid- by the health professionals while studies and guidelines show that covid- cases had a runny nose, sore throat, a cough, and fever. , , , out of respondents, ( . %) were responded as covid- is a zoonotic disease. based on this study, ( . %) of health professionals explained as covid- is % fatal while studies and guidelines show that the outcomes and prognosis of covid- accounts vast most cases had cured. on the other hand, covid- has been rapid progression to acute respiratory distress syndrome (ards), multiple organs failure, and sometimes death in small cases. the ratio case-fatality is currently unknown but is estimated to be within the range of . - %. among the critical ills, mortality was attributed to secondary bacterial infections with multi-drug resistant organisms, sepsis, and septic shock. in this study, ( . %) of health professionals explained as covid- affects all segments of the population. similarly, other studies showed that covid- had negative impact on all segments of the population even though there was an epidemiological and clinical difference among age and co-morbid conditions. , nearly ( . %) of health professionals explained as covid- have a specific treatment while to date, there is no specific treatment for this virus. the efficacy and safety of these candidate drugs in the treatment of covid- need to be confirmed in further preclinical and clinical trials. supportive care, including hospitalization and intensive care unit management, was the only therapeutic option. furthermore, the possibility that pneumonia caused by sars-cov- could, like influenza, potentiate fatal bacterial secondary infections need to be urgently investigated. about ( . %) of health professionals explained as covid- have vaccination while studies and guidelines show as there was no currently approved vaccine. direct contact is the most common mode of transmission for covid- mentioned by health professionals. in the case of independent factors associated with an awareness were the level of a profession in which about % of the study participants who were aware were degree while health professionals with a degree level of education were two times more likely to be aware than that of diploma (aor= . , % ci= . - . ) . there were no studies on the factors associated with the level of awareness to date to compare these findings. according to this study, more than half of the respondents ( ( . %)) who had a television at their homes were aware of covid- . health professionals who had a television at home were two times more aware of covid- than their counterparts. similarly, health professionals who had heard about emerging diseases were . times more likely to be aware of covid- than those who did not hear (aor= . , % ci= . . the authors conclude that the level of awareness on covid- by the health professionals was promising ( . %). the types and level of the profession, availability of television at home, and hearing of the emerging diseases in the past were factors determine the awareness of health professional on covid- . based on results found in this study, the authors recommended health institutions should have a system to address the expected competency of all health professionals during the pandemic like covid- . the practice of seminar presentation and selflearning among health professionals at the hospital level should also be strengthened. furthermore, the authors recommended researches on the awareness, utilization of different health promotion channels among health professionals. the study design was facility-based cross-sectional. so, it had its drawback (this does not show which one was come first effect or cause). all data are accessed in this manuscript. ethical clearance gained from debre birhan university research committee. the study protocol was evaluated and approved by the research ethics review committee [dbumf ] of college of health sciences, debre berhan university. supportive letter gained from zonal health office to all selected kebeles administrative office to get their cooperative letter to show for selected mother during the data collection. each study participant adequately informed about the purpose, method and anticipated benefit and risk of the study by their data collector. written consent was obtained from study participants. confidentiality and privacy kept by omitting the name of the respondents during data collection procedure. infection and drug resistance is an international, peer-reviewed openaccess journal that focuses on the optimal treatment of infection (bacterial, fungal and viral) and the development and institution of preventive strategies to minimize the development and spread of resistance. the journal is specifically concerned with the epidemiology of antibiotic resistance and the mechanisms of resistance development and diffusion in both hospitals and the community. the manuscript management system is completely online and includes a very quick and fair peerreview system, which is all easy to use. visit http://www.dovepress.com/ testimonials.php to read real quotes from published authors. what is novel coronavirus; frequently asked questions unicef_school_guidance_covid _v _english_ pm monday severer respiratory illness caused by a novel coronavirus-euro-surveillance covid - response plan coronavirus disease (covid- ) outbreaks in residential care facilities european centre for disease prevention and control. covid- situational report impact of the coronavirus covid- on the african economy african union report covid- in africa: a call for coordinated governance, improved health structures, and better data rapid evidence synthesis on covid- pandemic to inform the ethiopian ministry of health (moh) clinical management of suspected or confirmed covid- disease prevalence and impact of cardiovascular metabolic diseases on covid- in china covid- clinical guidance for the cardiovascular care team coronavirus disease (covid- ) estimating the potential impact of covid- on the australian economy the global macroeconomic impacts of covid- : seven scenarios covid- ) outbreak: rights, roles, and responsibilities of health workers, including key considerations for occupational safety and health a comparative study on the clinical features of covid- pneumonia to other pneumonia world health organization. golf industry guidelines to coronavirus (covid- ) novel coronavirus( -ncov) situation report identification of coronavirus isolated from a patient in korea with covid- . osong public health res perspect discovering drugs to treat coronavirus disease (covid- ) new coronavirus outbreak: framing questions for pandemic prevention what to do if you are sick with coronavirus disease (covid- ) contact transmission of covid- in south korea: novel investigation techniques for tracing contacts interim_guidance_for_businesses_ and_employers_to_ plan_and_ respond_ to_covid- feasibility of controlling covid- outbreaks by isolation of cases and contacts how should u.s. hospitals prepare for coronavirus disease (covid- )? the novel coronavirus (covid- ) infection in hangzhou: an experience to share geographical tracking and mapping of coronavirus disease covid- /severe acute respiratory syndrome coronavirus (sars-cov- ) epidemic and associated events around the world: how st century gis technologies are supporting the global fight against outbreaks and epidemics covid- ): protecting hospitals from the invisible acha's covid- task force. acha guidelines preparing for covid- guidelines for state employee leave time and staffing -covid- iasc interim guidance on covid- -focus on persons deprived of their liberty early epidemiological and clinical characteristics of cases of coronavirus disease in south korea chinese expert consensus on the perinatal and neonatal management for the prevention and control of the novel coronavirus infection the authors would like to thank debre berhan university and debre birhan town health bureau for providing sponsoring ship. all study participants are thankful for their cooperation during sample collection. all authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work. there is no funding to report. the authors declare that they have no competing interests. key: cord- - a pq e authors: freitas, Ângela; rodrigues, teresa c.; santana, paula title: assessing urban health inequities through a multidimensional and participatory framework: evidence from the euro-healthy project date: - - journal: j urban health doi: . /s - - - sha: doc_id: cord_uid: a pq e urban health inequities often reflect and follow the geographic patterns of inequality in the social, economic and environmental conditions within a city—the so-called determinants of health. evidence of patterns within these conditions can support decision-making by identifying where action is urgent and which policies and interventions are needed to mitigate negative impacts and enhance positive impacts. within the scope of the eu-funded project euro-healthy (shaping european policies to promote health equity), the city of lisbon was selected as a case study to apply a multidimensional and participatory assessment approach of urban health whose purpose was to inform the evaluation of policies and interventions with potential to address local health gaps. in this paper, we present the set of indicators identified as drivers of urban health inequities within the city of lisbon, exploring the added value of using a spatial indicator framework together with a participation process to orient a place-based assessment and to inform policies aimed at reducing health inequities. two workshops with a panel of local stakeholders from health and social care services, municipal departments (e.g. urban planning, environment, social rights and education) and non-governmental and community-based organizations were organized. the aim was to engage local stakeholders to identify locally critical situations and select indicators of health determinants from a spatial equity perspective. to support the analysis, a matrix of indicators of health determinants, with data disaggregated at the city neighbourhood scale, was constructed and was complemented with maps. the panel identified critical situations for urban health equity in indicators across eight intervention axes: economic conditions, social protection and security; education; demographic change; lifestyles and behaviours; physical environment; built environment; road safety and healthcare resources and performance. the geographical distribution of identified critical situations showed that all city neighbourhoods presented one or more problems. a group of neighbourhoods systematically perform worse in most indicators from different intervention axes, requiring not only priority action but mainly a multi- and intersectoral policy response. the indicator matrices and maps have provided a snapshot of urban inequities across different intervention axes, making a compelling argument for boosting intersectoral work across municipal departments and local stakeholders in the city of lisbon. this study, by integrating local evidence in combination with social elements, pinpoints the importance of a place-based approach for assessing urban health equity. abstract urban health inequities often reflect and follow the geographic patterns of inequality in the social, economic and environmental conditions within a citythe so-called determinants of health. evidence of patterns within these conditions can support decisionmaking by identifying where action is urgent and which policies and interventions are needed to mitigate negative impacts and enhance positive impacts. within the scope of the eu-funded project euro-healthy (shaping european policies to promote health equity), the city of lisbon was selected as a case study to apply a multidimensional and participatory assessment approach of urban health whose purpose was to inform the evaluation of policies and interventions with potential to address local health gaps. in this paper, we present the set of indicators identified as drivers of urban health inequities within the city of lisbon, exploring the added value of using a spatial indicator framework together with a participation process to orient a placebased assessment and to inform policies aimed at reducing health inequities. two workshops with a panel of local stakeholders from health and social care services, municipal departments (e.g. urban planning, environment, social rights and education) and nongovernmental and community-based organizations were organized. the aim was to engage local stakeholders to identify locally critical situations and select indicators of health determinants from a spatial equity perspective. to support the analysis, a matrix of indicators of health determinants, with data disaggregated at the city neighbourhood scale, was constructed and was complemented with maps. the panel identified critical situations for urban health equity in indicators across eight intervention axes: economic conditions, social protection and security; education; demographic change; lifestyles and behaviours; physical environment; built environment; road safety and healthcare resources and performance. the geographical distribution of identified critical situations showed that all city neighbourhoods presented one or more problems. a group of neighbourhoods systematically perform worse in most indicators from different intervention axes, requiring not only priority action but mainly a multi-and intersectoral policy response. the indicator matrices and maps have provided a snapshot of urban inequities across different intervention axes, making a compelling argument for boosting intersectoral work across municipal departments and local stakeholders in the city of lisbon. this study, by integrating local evidence in combination with social elements, pinpoints the introduction evidence on health inequities between and within cities has been globally documented across all countries and regions, regardless of the level of economic development and health system organization [ ] [ ] [ ] [ ] . the places where people live within a city and how that city is governed can shape individual and population health and create inequities [ , ] . there is ample evidence that health inequities have a spatial footprint, often following the geographical patterns of inequality in the social, economic, built and physical environmental conditions in which people are born, grow, live, work and age-the so-called social determinants of health (sdoh) [ , ] . these conditions are not distributed randomly within a city, the result of which creates different living conditions, degrees of vulnerability, levels of exposure to environmental risks and hazards, levels of access to resources, services and amenities and the populations' chances of living a flourishing life [ , [ ] [ ] [ ] [ ] . tackling the harmful effects of an unequal distribution of sdoh within a city is a matter of health equity and justice, understood here as principles underlying the commitment to provide conditions and opportunities to every individual to achieve good health and wellbeing, regardless of one's place of residence, ethnicity, age, gender identity, sexual orientation or economic and social situation, among any other status likely to cause disadvantage [ ] [ ] [ ] . policy decisions of different sectors shape processes that influence the distribution of urban determinants of health. examples of this include access to education, economic opportunities, social protection, safety, healthcare, social services, culture, sports and recreation, provision of housing, air and water quality, public transport, green spaces and healthy food [ , [ ] [ ] [ ] . for this reason, resulting inequities are considered both multidimensional and a complex problem: there are multiple contributors and multiple solutions, and these can neither be viewed in isolation nor understood without being situated in their place and local context [ , ] . while healthcare policy can go some of the way, when it comes to addressing the causes of urban health inequities, gains can only be achieved via the engagement and actions of other sectors. local and municipal governments play a very important role, not only by having the capacity to effect change through policies and interventions to address problems locally and allocate or redress the inequitable distribution of resources, but also due to their ability to work across sectors and with local stakeholders [ , [ ] [ ] [ ] [ ] . the united nations agenda for sustainable development, reflected in the new urban agenda [ ] and in the sustainable development goals (sdgs) [ ] , places strong emphasis on the leadership role played by cities when taking action to create healthier and more sustainable environments as they are considered the settings that hold the highest potential to address the determinants of health. in this context, it is important to note the work that the who healthy cities movement has been developing over the last years to put health on the social, economic and political agendas of city governments across the globe. embedded is the recognition that more effective initiatives to address health inequities require a shift of paradigm in health promotion: we must reduce "the focus on individual behavior change interventions within settings and focus more on interventions which change the structure of setting themselves as this is what constitutes action on broader determinants of health inequities" (p ) . yet, in an environment of great complexity, the following question arises: "what issues should governments consider when trying to identify what evidence is useful?" (p ) evidence-based policy is based on the principle that decisions are informed by available evidence and this should include a rational analysis [ ] capable of representing the key issues, illustrating the gaps in equity among neighbourhoods, and ultimately inform action to close those gaps [ ] [ ] [ ] [ ] . several initiatives have been undertaken over the last years to compile and standardize urban health indicators with the aim of informing urban policy and decision-making; worthy of mention is the who urban health equity assessment and response tool-urban heart [ , ] . recent literature reviews on the development and use of metrics for analysing urban health equity highlight the existent plethora of indicator frameworks which exhibit great diversity in the aim, spatial scale, domains analysed, characteristics measured, indicator selection methodology and data visualization [ , [ ] [ ] [ ] [ ] . a system of urban health equity indicators using "area-level health determinants" is of considerable value to city mayors, municipal departments and other local stakeholders because they allow for monitoring related inequities across place and time and address critical situations and set priorities [ ] . furthermore, disaggregated data at the level of city neighbourhood invariably reveal inequities, stemming from a locational or "placebased" disadvantage. within a setting that is geographical by nature-the city-the adoption of a place-based approach allows for the analysis of health inequities through a lens that incorporates data on local indicators (of economic, social, physical and built environment) [ ] and involves multiple stakeholders and the community [ , [ ] [ ] [ ] [ ] . making sound decisions to determine the primary inequities to address, thus producing desirable outcomes for population health, is both a technical and a social process [ ] . the inherent complexity and multidimensionality of assessing urban health demand evidence from multiple fields of knowledge and the engagement of stakeholders from different sectors [ , ] . participation processes at the local level are broadly advocated and considered a current trend in urban health studies [ ] , not only because they provide a venue for inclusive decision-making [ ] but more importantly contribute to efforts to reach agreement on an issue where plurality and heterogeneity of points of view arise [ ] . stakeholders have a wide range of social values and interests that result in different perceptions of what evidence is most useful and relevant to guide priority setting [ ] . this necessarily involves an effective use of stakeholders from a wide range of fields interpreting that evidence for them in a clear way and applying appropriate approaches to elicit information from them, thus making their perspectives explicit when making choices [ , ] . the euro-healthy project (shaping european policies to promote health equity) was a -year project ( - ) funded by the european commission to advance knowledge on policies with the highest potential to promote health equity across european regions, with a specific focus on urban areas. at its core is the application of a multidimensional and participatory approach to population health with the goal of understanding the key drivers of health inequities and advancing evidence and methods to better inform policymakers at different decision-making levels, the european union (eu), national, regional and local [ , , ] . the flagship tool of this project is a population health index (phi), a measure that characterizes european population health across multiple areas of concern, dimensions and indicators of health determinants and health outcomes [ ] [ ] [ ] [ ] . the city of lisbon was engaged in this project as a case study for the analysis and evaluation of policies with potential to promote health equity on an urban scale. the specific aim was to analyse municipal policies considering not only the benefit to promote health and reduce inequities in the sdoh among city neighbourhoods but also the doability [ ] in light of two scenarios for the evolution of health inequalities in europe (detailed information can be found in [ ] ) [ ] . a fundamental step was to build the evidence base for the policy evaluation exercise, which comprised the structuring of intervention axes (areas of concern in which the city has problems that can be addressed by policies) and the definition of a multidimensional set of indicators reflecting the status quo of urban health equity issues in lisbon. this paper describes this first stage of assessment and the respective outputs, namely the set of indicators identified as drivers of place-based health inequities and the implications for future policy prioritization. the design of this socio-technical process was based on the following key assumptions and principles: (i) multidimensionality of urban health equity: recognition that multiple conditions influence urban health and sdoh are entry points for action to promote health equity, as the analysis of their unequal distribution within a city represents a crucial requirement to identify appropriate policy responses [ , , , ] ; (ii) evidence-based: informed by key sdoh and looking to all urban features likely to produce health inequities, the domains defined for analysing urban health inequities in lisbon follow the areas of concern considered relevant to evaluate population health in the european context, under the euro-healthy project [ , , , ] ; (iii) data-driven and context-specific: availability of data to measure indicators that are relevant for the specific context and can characterize local conditions. data is gathered from area-level indicators to capture geographical inequalities, with readily available data representative at the neighbourhood scale [ , , , , ] ; (iv) data quality and validity: the selection of indicators is based on readily available and timely data at the local level, obtained from official and accurate data sources that report current rather than historic data [ , ] ; (v) policy-relevant and action oriented: indicators need to be linked to policies and interventions with potential to effect change at the local level. indicators provide information that is understood by those responsible for taking action and are considered appropriate and useful for guiding local decision-making. data is spatially disaggregated at the neighbourhood level to inform place-based and multisectoral action [ , , , ] ; (vi) stakeholder engagement: a range of stakeholders from a variety of backgrounds must be involved, as local knowledge is considered vital, alongside with data, when it comes to both identifying and analysing context-specific urban health inequities. the engagement of key players includes local government, healthcare services and local associations and community groups. the objective is not necessarily to reach mutual consensus or to come to a joint decision on what the priority interventions will be, given that it is the policymakers who ultimately hold the final authority and are held accountable for final decisions [ , , ] .; (vii) participation and collaborative process: the participatory process is designed to promote shared understanding about urban health inequities while capturing multiple stakeholders' values and perspectives, creating a collaborative environment that enables management of eventual conflicts of values and promote agreement. the aim is to create a joint learning experience as a means of creating space for all stakeholders to express their views [ , , , ] . (viii) output validity: the outputs must be considered valid, that is, able to reflect what it is intended to reflect as relevant and meaningful for the specific context of evaluation and local situation (contextual validity), by the group of stakeholders actively engaged in the participatory process (participatory validity). here, validation is assessed through "face validity" [ ] , that is, in the view of the evidence presented (indicator data) and the variety of perspectives, the group considers that the indicators selected provide a general picture and are representative of the main drivers of urban health inequities (intersubjective and content validity). additionally, the process must increase empathy among the participants (empathy validity) [ , , ] . the process of identification of urban health inequities in the city of lisbon involved three steps: the formation of a local stakeholder panel ( step ), the development of a provisional list of indicators of sdoh and collection of available data at a neighbourhood level (step ) and the organization of stakeholder workshops to consult and collect views on what indicators are influencing urban health inequities and where (in which neighbourhoods) the action addressing identified issues is more needed (step ). in the following sections, more information is provided on the panel members, indicator data and workshop protocol. step : formation of the local stakeholder panel a total of individuals, representing regional and local institutions from different sectors, were invited to participate and form the local stakeholder panel. a welcome and introductory session was organized to allow stakeholders to (i) become better acquainted and engage with the topic of urban health and health equity from a sdoh approach; (ii) have a general overview of the lisbon case study, namely its objectives and methodological approach, and (iii) share commitment towards their roles and tasks. overall, the panel represented different stakeholder groups: (i) local and regional government (including elected officials and officers from various departments linked to urban determinants of health); (ii) charities and other non-profit and nongovernmental organizations (e.g. working in the field with vulnerable or marginalized populations) and (iii) public health and healthcare (e.g. from primary healthcare and regional health planning) (table ) . step informed by the euro-healthy project [ , , , ] , eight independent intervention axes for appraising health were considered: (i) economic conditions, social protection and security, (ii) education, (iii) demographic change, (iv) lifestyle and health behaviours, road safety and (viii) healthcare resources and performance. to investigate how lisbon performed in these intervention axes, the research team selected indicators to be included in the provisional matrices. along with the need to be context-specific (relevant for the context of the city of lisbon), the selection of indicators was based on the following criteria: (i) ability to describe and measure one relevant aspect for health within each intervention axis (e.g. socioeconomic characteristics of population within economic conditions, social protection and security; environmental factors that can influence health within built environment and physical environment); (ii) address health determinants that can be shaped by local policies and interventions, (iii) data disaggregation at the civil parish scale, to capture inequalities and enable the intra-city analysis of inequities and (iv) data quality and validity. indicator data was collected for the municipality of lisbon, at the civil parish level (the smallest administrative unit in portugal), for the year with the most recent data (between and ) and relied, as much as possible, on the use of available datasets from official statistics. together with the use of indicators provided by statistics portugal (e.g. census data on population, employment, education, housing), a number of indicators were built by the research team, specifically for this study, using data provided by the city departments (e.g. data on pollution, built environment, transportation, social and healthcare services) and by stakeholders involved in the study, representing local ngos (e.g. data on the living conditions of vulnerable populations, such as the elderly and homeless). the municipality of lisbon supported the data collection by authorizing access to local databases and geographical data (for mapping). as complementary to the main list of indicators of health determinants, data on health outcomes (e.g. mortality by cause of death, disease incidence rates, hospital discharges) were also collected and mapped at the civil parish level. for each indicator, relevant information was gathered in the form of an identity card with the following attributes: (i) indicator metadata (name of indicator, definition, unit of measurement, calculation, geographical scale, year of data, data source), (ii) indicator purpose (health-based rationale stating how the indicator effects health) and (iii) map showing the respective geographical distribution across the city of lisbon (data disaggregated at the civil parish level) (see fig. ). step : workshops two workshops were held in lisbon between november and february . in the first workshop, participants were divided into three multidisciplinary workgroups. each group was assigned a specific set of intervention axes and respective indicators according to the stakeholders' area of expertise or work ( table ). the aim of each workgroup was to identify locally critical situations with respect to health determinant inequities and select indicators that may be entry points for priority intervention. the workshop protocol was built around the analysis of data collected on indicators based on the following questions: [ ] what indicators (health determinants) are the key drivers of local health inequities? and [ ] where (in which civil parishes) is the priority action that addresses those indicators most needed? to support the analysis, the research team prepared material for consultation in the workshops. the consultation material included the following documents: (i) three indicator matrices with the indicators of health determinants (in rows) and respective performances in each geographic unit- civil parishes (in columns) across the eight intervention axes and (ii) a dossier with each indicator identity card, with metadata, its "population health meaning", that is, its relevance and how it effects health, and a map showing how the indicator varies across the civil parishes. each participant was provided with a matrix, in line with the axes assigned to the respective workgroup (see figs. , and ) . the indicator data was organized in the matrix in such a way that participants could easily analyse the performance of each civil parish for each indicator against given benchmarks: the city average, the worst and the best performances within the municipality of lisbon. each of the civil parishes was colour-coded for each of the indicators using the following metric: performances worse than the city average (cells shaded in dark grey) and performances better than the city average (cells shaded in light grey). in each indicator, the two best (and worst) city parishes were also highlighted (performance in bold). the colour attributed to the "worse than/worst" and "better than/best" performances reflect a value judgement considering the potential effect of the indicator on population health. for instance, a civil parish presenting higher percentages of unemployed people when compared with the city average is colour-coded in dark grey, considering that high levels of unemployment have a negative impact on health. in this first workshop, two exercises were conducted. the first exercise was to seek the opinion of each participant as to which civil parish/indicator represented critical situations for health equity in the city of lisbon by marking the cells in question red. for the purpose of this study, a critical situation depicted a civil parish where, in light of the evidence provided, its performance in one or more indicators would potentially have a negative effect on health equity in the municipality and should consequently be considered a priority for intervention. the analysis was individual and was made in light of the consultation material provided, namely the publication which included the indicator's identity card and respective maps (see fig. a ). the second exercise was to discuss the individual assessments (matrices with cells coloured red) within each workgroup and to reach a tentative agreement on a set of indicators considered problematic situations and potential entry points for intervention (see fig. b ). after the workshop, and in order to reach a clear and effective agreement on a single matrix of critical situations by workgroup, individual matrices were analysed by applying a majority agreement rule. the workgroup opinion (aggregate of individual assessments) was calculated taking into account the number of participants who had shaded a cell in red in relation with the total number of participants in the workgroup. then, a single workgroup matrix was built showing the cells shaded red by more than % of the participants. the second workshop was performed to validate the resulting single workgroup matrices. the three workgroups were presented with the respective aggregate of individual assessments and given the opportunity to revise the single workgroup matrix and to remove, change or add critical situations (fig. c) . the main aim of the assessment was to obtain a comprehensive picture of the critical situations across the city by examining the geographical distribution of several health determinants at the neighbourhood scale (civil parishes). the final matrix with the identification of the critical situations (cells coloured in red) reflects the indicators and the geographical areas with the poorer performances, pinpointing the status quo of inequalities that should be addressed in order to promote equity in the city of lisbon. the assessment was made considering eight independent intervention axes, meaning that stakeholders worked each intervention axis independently without prioritizing one above the other, and that participants did not weigh the importance or ranked indicators. in the matrix and within each independent intervention axis, they identified the respective indicators and the civil parishes that, given the material provided (data and maps) together with their own local knowledge and perceptions, are in "red alert". the final matrix of critical situations is shown in fig. . from the initial set of indicators, a total of were selected ( %), representing a wide range of health determinants where one or more civil parishes revealed worse performances and were marked red (see table ). from this list, more than one third ( . %, indicators) are from built environment. there are three intervention axes where all the indicators included in the provisional matrix were selected; this occurred with lifestyles and health behaviours, physical environment and road safety. an examination of the distribution of critical situations identified by majority shows that all civil parishes registered red cells in one or more indicators. the indicators unemployment rate (%) and school drop-out (%) encompassed almost half of the civil parishes marked in red ( out of ). the number of red cells per civil parish in the matrix also varies widely, from only one in the civil parish estrela to in beato ( . % of all indicators). figure shows that the geographical distribution of critical situations is not homogeneous across civil parishes and across the eight intervention axes. almost all civil parishes ( out of ) present critical situations within built environment axis (in one to nine indicators). in contrast, within lifestyles and health behaviours, here measured by one indicator (live births from overall, the higher number of critical situations is concentrated in the eastern part of the city (civil parishes of beato, marvila, penha de frança) and in the historic city centre (santa maria maior, são vicente, misericórdia) comprising neighbourhoods located along the tagus riverfront area. this is more evident in the following intervention axes: economic conditions, social protection and security, education, demographic change, built environment and healthcare resources and performance. the identification of critical situations within physical environment (mainly in the indicators of air pollution) and road safety (road traffic accidents) showed a different spatial pattern, being concentrated in the civil parishes located along the intersection of main roads and highways that traverse the city from north to south (e.g. eixo norte-sul) and from east to west (e.g. the °c ircular ring road). urban health indicator frameworks are considered useful tools with the aim of informing urban policy and decision-making. in this study, a place-based approach was applied to assess urban health inequities in the city of lisbon, using a spatial indicator framework together with a participation process. a total of local stakeholders, including city officials, participated in two workshops where they had the opportunity to discuss urban issues from a population health perspective and identify critical situations across the city. the main output is the generation of a matrix of health determinants that are deemed representative of existent inequities across eight intervention axes (critical situations reflect the indicators and the geographical areas with worse performances). together, these indicators, disaggregated at the parish scale, provide a picture of inequalities that should be addressed by local policies and interventions in order to promote equity in the city of lisbon. critical situations were identified in indicators covering a wide range of health determinants (e.g. unemployment, early school leaving, older adults living in social isolation, air pollution, noise exposure, inadequate housing conditions, road accidents involving pedestrians). the intervention axis of built environment was found to have the highest number of critical situations (cells were marked red in indicators and civil parishes) mainly reflecting poor housing and building conditions (e.g. households without central heating, buildings without wheelchair access, buildings in need of major repairs or very run-down) that persist in many civil parishes of lisbon. similarly, concerns related to urban mobility and transportation within the city were highlighted. a total of civil parishes were marked as critical due to low percentages of the population using public transportation and soft modes of mobility (e.g. walking, cycling). this confirms the need to change the existing mobility paradigm to a more sustainable one, which is already an expressed priority of the lisbon city government for the next decade. overall, several civil parishes systematically perform worse in most of the indicators of health determinants (accumulating critical situations) when compared with the others, making these neighbourhoods a priority for intervention. the eastern part of the city (civil parishes of marvila and beato) and certain neighbourhoods in the city centre are characterized by higher rates of socio- material deprivation and are home to vulnerable populations, such as older adults living in poor housing conditions or social isolation. furthermore, the indicators of unemployment and school drop-out were considered critical issues across a considerable section of the municipality (in out of civil parishes). these indicators are a reflection of the deterioration of socioeconomic conditions driven by the - economic and financial crisis that hit portugal and, in particular, lisbon. addressing socioeconomic and educational inequities, namely employment and education, were considered by stakeholders as key to promoting health and equity. this study presents a general framework to assess urban health inequities, useful to identify priority issues and neighbourhoods needing policy intervention. the indicators identified as critical situations for health equity are from diverse intervention axes, linked directly to the action of many municipal departments and dependent on place-based interventions (e.g. reducing pollution, improving housing, territorial and social cohesion, urban design, mobility). the indicator framework described in this study present a number of characteristics that are considered by pineo and colleagues [ ] as facilitators to the use of urban health indicators by local government: (ii) neighbourhood-scale data; (iii) indicators from social and built environment; (iv) local and diverse knowledge are incorporated via a participation process [ ] . the interconnectedness among those situations identified as critical serves to reinforce the need for an integrated approach to urban health in lisbon and the implementation of a health in all policies (hiap) strategy [ , ] . in the words of the local city councillor for social rights, "this case study highlighted the link between health determinants ( a s s e s s m e n t ) a n d po l i c y a c t i o n ( r e s p o n s e ) , emphasizing the role that non-healthcare sectors (from social assistance to urban planning to housing) have on promoting health equity". in portugal, the responsibility for public health is a very centralized, one that to a large degree still remains in the hands of the health sector through regional health administrations. additionally, the use of participation processes in local decision-making is considered modest with a deficit of stakeholder engagement and intersectoral work. integrating health equity in all policies, specifically into local plans, requires an effective political will and commitment as key elements to act upon the causes of health inequalities at the municipal level [ ] . the recent decentralization of competences to municipalities and inter-municipal associations (law / , january ) endowed local governments with a more formal health mandate and can offer space to design effective policies addressing population health needs. within the scope of new competences, municipalities are responsible for developing a municipal health plan, a strategy document that contains a comprehensive picture of municipal health issues, priorities and plan for actions. this study can provide a basis for developing the municipal scan (first stage of the planning process), providing a place-based and context-specific approach to population health, focusing on multiple determinants of health inequities and on how they are distributed among city neighbourhoods. a good understanding of determinants of health outcomes, together with evidence on their geographical inequalities, are vital to informing decisionmaking at multiple levels (at the civil parish, municipal and metropolitan levels) and to orientating the prioritization of critical issues to address [ ] . the participation of different groups of stakeholders (local and regional government, charities and other nonprofit associations and ngos, public health and healthcare services) working in the municipality and in varied fields of intervention contributes to raising and (b and c) . a consultation material. b workshop . c workshop awareness on the importance of implementing intersectoral and interinstitutional action [ ] . overall, at the end of the workshops, stakeholders stated that they gained new insights and broadened their views on while they recognized this participatory process as very important to initiating a dialogue and leveraging intersectoral action targeting the identified urban health issues, it may not be effective by itself in the process of influencing decision-making to change the status quo of health inequalities within the city. there is no great tradition in portuguese municipalities to conduct participation processes with local stakeholders, and intersectoral action for health still lags behind in comparison with other countries. for example, city departments work in silos and do not collaborate very often. to our knowledge, this was the first participation and collaborative process on urban health and related inequities to take place in lisbon, here understood through the lens of sdoh and hiap approaches. youth neither employed nor in education or training (neet) (%) homeless people (n°) people receiving social integration subsidies (number per active population) ( out of ) school drop-out rate (%) demographic change ( out of ) older adults living alone and in social isolation (%) older adults reporting limitations/disabilities (%) older adults living in buildings with floors or more without elevator (%) lifestyles and hbs ( out of ) live births from adolescent mothers (age under ) (%) physical environment ( out of ) particulate matter (pm ) concentrations (μg/m ) population exposed to noise levels greater than lden db (%) population potentially affected by flooding (%) built environment ( out of ) overcrowded housing (%) households without central heating (%) buildings without wheelchair access (%) buildings in need of major repairs or very run-down (%) walkability index average walking distance to the nearest adult day-care centre (minutes) average walking distance to the nearest sports facility (minutes) capacity after the case study of lisbon, the research team continued to collaborate with the city council, extending this study to the field of policy analysis and prioritization using participation processes with the same group of stakeholders. in , two participatory processes were organized in which city departments, civil parishes and local stakeholders from multiple sectors engaged with the topic "intersectoral action to promote urban health equity in lisbon". however, changes in the governance structure and policymaking process that incorporate health equity considerations in city plans are dependent upon strong political will and commitment. fig. geographical distribution of identified critical situations by intervention axis, in the municipality of lisbon. note: civil parishes are coloured using a monochromatic colour scheme with a gradient ranging from light red to dark red according to the number of indicators identified by the majority as a critical situation. civil parishes in light red were marked as critical in less than % of the indicators selected in the intervention axis. civil parishes in dark red were marked as critical in more than % of the selected indicators. civil parishes in white were not marked red for any indicator of the intervention axis. political conviction and extended governance, including the involvement and participation of practitioners and citizens in the evaluation and selection of policies, are critical in the city's efforts to move towards achieving urban health equity. this topic will be explored in a subsequent paper analysing which municipal policies have the greatest potential to reduce urban health inequalities in lisbon in light of the evidence gathered in this study. a list of policies and actions addressing the identified critical situations (indicators and civil parishes) was produced and analysed in consideration of their overall benefit to reducing inequities in each intervention axis. finally, the current global challenge to health equity, posed by the covid- pandemic, places greater urgency in the analysis of current sdoh inequities at the local level. covid- , and the wider governmental and societal response, have brought existing health inequalities into keener focus [ , ] . the emerging debate on the pivotal role of local government in addressing the virus outbreak includes recommendations to integrate responses tailored to the local context and oriented to neighbourhoods with worse health determinants (e.g. overcrowded housing, poor sanitation, socioeconomic deprivation, lack of green spaces, poor access to healthcare). this study could provide a basis for adopting a place-based and territorially sensitive approach to prioritize those neighbourhoods in most need, as well as to inform intersectoral action and collaborative work across municipal departments and public health stakeholders in the city of lisbon. the methodology used can provide input that informs local plans and strategies. the use of area-level indicators was an efficient means of analysing existing variations in health determinants and identifying those neighbourhoods that need to be prioritized [ , , ] . a simple indicator matrix combined with a convivial workshop protocol offered an integrated, transparent and comprehensive way of examining urban inequities, by including indicators from different intervention axes and area-level data at the civil parish scale. the material for consultation provided during the workshops in the form of maps and indicator's identity card (together with indicators of health outcomes) allowed stakeholders to better understand how the unequal distribution of health determinants across lisbon is potentially contributing to health inequities. stakeholders had the opportunity to analyse the overlapping pattern between worse performances in health determinants and worse performances in health outcomes. the workshop format provided face-to-face interaction enabling the participants to work in small groups thus affording them a space for the in-depth exploration of indicator data and the exchange of points of view and perspectives, not all of which were perfectly concordant. at the beginning of the workshop, the research team presented the assumptions and principles followed in the design of the exercise. the aim was to introduce the objective of the exercise and guide the assessment towards the identification of critical situations in each intervention axis to inform decision-making and future prioritization. the assessment was carried out across eight independent intervention axes, meaning that stakeholders worked each intervention axis independently and did not prioritize one above the other. the research team acted as facilitators in the group discussion, providing clarifications on the consultation material and helping to keep participants engaged and focused on the aim of the workshop, allowing all voices to be heard and leaving participants willing to engage in further discussion. the role of the research team was not to influence the results but to create the environment for effective communication so both disagreement and mutual understanding could surface. in the group discussion phase, each participant had the opportunity to present their own opinions on indicators. by asking stakeholders to review and discuss the final matrix, mistakes and instances of underreporting were detected and clarified. overall, participants showed agreement on the list presented, stating that the list was very comprehensive, already integrating enough determinants from a wide range of relevant dimensions to assess lisbon urban health. the assumption of "outputs validity" was reached [ , ] : stakeholders acknowledged that the results are accurate, clear and transparent and provide a comprehensive picture of the equity problems the city is facing. the preliminary matrix of indicators was built with measurable variables, reflecting the status quo of an urban community (civil parish) generated through valid and available data from official statistics. one of the criteria underlying a good indicator framework informing a place-oriented intervention to urban health equity is exhaustivity, that is, indicators which measure different health determinants (all eight intervention axes had to include one or more indicators) and allow for monitoring inequality across time and space. similar to other urban health assessments reported in the literature [ , ] , the availability of data disaggregated at the parish level was considered paramount in the case study of lisbon although it also offered some barriers. a specific limitation was data collection at the parish level for some very relevant indicators to assess urban health equity, such as household income or cost of housing. in recent years, the access to affordable and adequate housing, linked to the growing gentrification taking place in many neighbourhoods, is considered the main issue affecting urban equity in lisbon and is currently a top priority in terms of policies reflecting social justice. at the time this study was being developed, there was no information available and reliable on this topic at the parish level. additionally, participants claimed the need to include lifestyles and health behaviours in the assessment (e.g. alcohol and tobacco consumption, physical activity levels, diet). yet, they immediately recognized the data constraints regarding the availability of these indicators at the local level. this case study does not prescribe a specific approach or set of indicators for use on every urban health assessment. in fact, current frameworks or indicator's systems of urban health differ substantially, reflecting the diversity of purpose [ , ] . however, there is some homogeneity in terms of the domains or dimensions of analysis. indicators used in the lisbon case study can be identified as examples of indicators of relevance to urban areas such as those relating to socioeconomic conditions and physical and built environment. as an example, similarities can be found with the who urban health equity assessment and response tool-urban heart, where the urban health assessment departs from an indicator matrix with data disaggregated at the neighbourhood level [ ] . establishing a framework for indicators should be meaningful for the context and city, using locally available data, to effectively address the needs of each neighbourhood. promoting health equity is a place-based issue. this study, by integrating local data in combination with a participatory process, pinpoints the added value of a context-specific and place-based approach for assessing urban health inequities. the use of indicator matrices and maps made it possible to see-in a simple, transparent and comprehensive way-geographical variations on multiple determinants of health across eight intervention axes considered relevant to promote health equity. evidence of these patterns supported stakeholder's analysis on what health determinants are shaping local health inequities and where (in which civil parishes) action is urgent. the results show that some civil parishes systematically perform worse in most of the indicators when compared with the others, thus becoming a priority for intervention. critical situations were identified in indicators covering a wide range of health determinants (e.g. social and economic, built and physical environment) linked to the action of many municipal departments and ones that can be addressed by city plans. the participation process created a collaborative environment, offering opportunities for researchers, policymakers and practitioners to engage in dialogue and co-learning on the importance of assessing and monitoring urban health through neighbourhood-level health determinants. finally, this study could provide a basis for adopting a place-based and territorially sensitive approach to prioritizing those neighbourhoods in most need, as well as to inform intersectoral action and collaborative work across municipal departments and local stakeholders in the city of lisbon. homem gouveia and teresa craveiro; civil parish council: maria capitolina marques; regional coordination and development commission scml): filomena gerardo, maria luís calinas and noémia silveiro; médicos do mundo (doctors of the world): fernando vasco marques; diabetes portugal (portuguese diabetes association-apdp): rogério ribeiro alzheimer portugal (portuguese alzheimer's association): ana sofia gomes and filipa gomes; observatório -luta contra a pobreza na cidade de lisboa (lisbon observatory for the european anti-poverty network-eapn): catarina cruz; the directorate-general of health (dgs/national health plan): rui portugal faculty of medicine of the university of lisbon (fmul): paulo nicola; primary health care fátima quitério; primary health care center group of western lisbon and oeiras (aces lisboa ocidental e oeiras): fátima nogueira and rafic nordin. finally, we would like to thank our english language reviewer grant agreement no , and received support from the centre of studies in geography and spatial planning (cegot), funded by national funds through the foundation for science and technology (fct) under the reference uid/geo/ / . angela freitas is a recipient of an individual doctoral fellowship funded by national funds through the foundation for science and technology (fct), under the reference sfrh/bd/ / . references . who and un-habitat. hidden cities: unmasking and overcoming health inequities in urban settings global report on urban health: equitable, healthier cities for sustainable development atlas of population health in european union regions population health inequalities across and within european metropolitan areas through the lens of the euro-healthy population health index healthy city planning: from neighbourhood to national health equity global report on urban health: equitable, healthier cities for sustainable development closing the gap in a generation: health equity through action on the social determinants of health. final report of the commission on social determinants of health. geneva: world health organization inequities in the freedom to lead a flourishing and healthy life: issues for healthy public policy urban place 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barcelona: a tool for action mapping environmental inequalities relevant for health for informing urban planning interventions-a case study in the city of dortmund, germany health equity and covid- : global perspectives the covid- pandemic and health inequalities acknowledgements the authors would like both to acknowledge the support received from the municipality of lisbon (cml) and to express gratitude for the opportunity to work with the city of lisbon in a case study. namely, the authors sincerely thank joão afonso (city councillor for social rights between and -cml/pds), teresa craveiro and her team (municipal health and wellbeing plan of lisbon-cml/ep-plhds) for the active involvement and support provided throughout the case study, namely in the preparation of workshops and support given on data collection. the authors are also grateful to the investigators involved in the preparation of the consultation materials that informed the workshops (indicator's identity card, tables and maps), namely adriana loureiro, claudia costa, ricardo almendra and joaquim patriarca from the university of coimbra and investigators involved in the design of the overall methodological approach of the euro-healhy project, namely paulo correia, carlos bana e costa and mónica oliveira from the instituto superior técnico, university of lisbon.then, we would like to gratefully acknowledge the participation of all local stakeholders involved in the participatory process (see list of institutions/participants below). disclosure statement the authors declare that they have no conflict of interest. key: cord- -xuiswu l authors: wang, weier; tang, jianming; wei, fangqiang title: updated understanding of the outbreak of novel coronavirus ( ‐ncov) in wuhan, china date: - - journal: j med virol doi: . /jmv. sha: doc_id: cord_uid: xuiswu l to help health workers and the public recognize and deal with the novel coronavirus ( ‐ncov) quickly, effectively, and calmly with an updated understanding. a comprehensive search from chinese and worldwide official websites and announcements was performed between december and : am january (beijing time). a latest summary of ‐ncov and the current outbreak was drawn. up to pm, january , a total of cases of ‐ncov infection were confirmed in mainland china with a total of deaths having occurred. the latest mortality was approximately . % with a total of cases still suspected. the china national health commission reported the details of the first deaths up to pm, january . the deaths included males and females. the median age of the people who died was (range ‐ ) years. fever ( . %) and cough ( . %) were the most common first symptoms among those who died. the median number of days from the occurence of the first symptom to death was . (range ‐ ) days, and it tended to be shorter among people aged years or more ( . [range ‐ ] days) than those aged less than years ( [range ‐ ] days; p = . ). the ‐ncov infection is spreading and its incidence is increasing nationwide. the first deaths occurred mostly in elderly people, among whom the disease might progress faster. the public should still be cautious in dealing with the virus and pay more attention to protecting the elderly people from the virus. , japan ( ), south korea ( ), vietnam ( ), nepal ( ) the rest cases unlocated | suggested bats or snakes to be the potential natural reservoir of -ncov. however, based on the latest statement by who on january , the source of -ncov is still unknown. the -ncov appears to cause symptoms similar to sars based on clinical data from the initial cases and seems to be capable of spreading from humans to humans and between cities, according to two latest studies , published in lancet on january . although who suggested that the current event did not constitute a public health emergency of international concern (pheic), they also indicated that the situation was urgent and needed further examination. january , january , the distribution of -ncov infection in china and worldwide is shown in table and figure . as listed in table ( ), yunnan ( ), tianjin ( ), shanxi ( ), heilongjiang ( ), hebei ( ), guizhou ( ), gansu( ), jilin ( ), xinjiang ( ), ningxia ( ), ( ), qinghai ( ) hong kong ( ), states ( ), japan ( ), south korea ( ), vietnam ( ), nepal ( ), australia ( ) the rest cases unlocated our study also showed that the first occurred deaths were mainly among elderly people. although most of them had comorbidities or a history of surgery before admission, the potential association of underlying medical conditions and -ncov-associated death was not clear. by far, the median number of days of first symptom to death was , which was comparable to that of days (median) of mers. for sars, it was reported that the average duration of first symptoms to hospital admission was . days, and admission to death was . days for casualties. our study also found that people years or older had shorter median days ( . days) from the first symptom to death than those with ages below years ( days), demonstrating that elderly people might have faster disease progression than younger people. similar results were found in sars in that the mean duration from admission to death was . days for people aged to years, . days for those aged to years, and above . days for those under years of age. it was also reported that older age (> years) was a risk factor that correlated with mortality in mers. in addition, the who also provided an interim guidance for infection prevention and control when a novel coronavirus was suspected and further improved the guidance by indicating that patients with mild symptoms and without chronic conditions or symptomatic patients no longer requiring hospitalization might be cared for in home environment. another aspect worth noting is that health workers should minimize the possibility of exposure when collecting and transporting lab specimens of suspected infected patients. , a goggle was necessary when health workers were questioning patients at fever clinics or performing operations for suspected patients since the virus might infect the eye conjunctiva through droplets. it would be interesting to test if robotics might be used in questioning or treating the infected or suspected patients, which will definitely decrease the possibility of exposure of health workers. although the etiology is still unclear, some scholars suggest that -ncov and sars/sars-like coronaviruses may share a common ancestor resembling the bat coronavirus hku - . the -ncov may interact with human ace molecules via its s-protein for human -to-human transmission. however, future studies are warranted to uncover the source of the virus and potential mechanisms for humanto-human transmission. the -ncov infection is spreading fast with an increasing number of infected patients nationwide. the future development of the disease is not clear but the public should be cautious in dealing with the virus since it may be very contagious. the first occurred deaths were majorly elderly people who might have faster disease progression. the public should pay more attention to protecting elderly people who have contracted the virus. wuhan municipal health commission's briefing on the pneumonia epidemic situation xinhuanet. new-type coronavirus causes pneumonia in wuhan: expert. released on global health concern stirred by emerging viral infections national health commission's briefing on the pneumonia epidemic situation coronaviruses: genome structure, replication, and pathogenesis molecular evolution analysis and geographic investigation of severe acute respiratory syndrome coronavirus -like virus in palm civets at an animal market and on farms bats are natural reservoirs of sars-like coronaviruses evolution of the novel coronavirus from the ongoing wuhan outbreak and 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wuhan the authors declare that there are no conflict of interests. http://orcid.org/ - - - key: cord- -aapg af authors: tambo, ernest; tang, shenglan; ai, lin; zhou, xiao-nong title: the value of china-africa health development initiatives in strengthening “one health” strategy date: - - journal: global health journal doi: . /s - ( ) - sha: doc_id: cord_uid: aapg af implementing national to community-based “one health” strategy for human, animal and environmental challenges and migrating-led consequences offer great opportunities, and its value of sustained development and wellbeing is an imperative. “one health” strategy in policy commitment, partnership and financial investment are much needed in advocacy, contextual health human-animal and environmental development. therefore, appropriate and evidence-based handling and management strategies in moving forward universal health coverage and sustainable development goals (sdgs) are essential components to the china-africa health development initiatives. it is necessary to understand how to strengthen robust and sustainable “one health” approach implementation in national and regional public health and disaster risk reduction programs. understanding the foundation of “one health” strategy in china-africa public health cooperation is crucial in fostering health systems preparedness and smart response against emerging and re-emerging threats and epidemics. building the value of china-africa “one health” strategy partnerships, frameworks and capacity development and implementation through leveraging on current and innovative china-africa health initiatives, but also, mobilizing efforts on climatic changes and disasters mitigation and lifestyle adaptations strategies against emerging and current infectious diseases threats are essential to establish epidemic surveillance-response system under the concept of global collaborative coordination and lasting financing mechanisms. further strengthen local infrastructure and workforce capacity, participatory accountability and transparency on “one health” approach will benefit to set up infectious diseases of poverty projects, and effective monitoring and evaluation systems in achieving african union agenda and sdgs targets both in africa and china. the china-africa partnership is one of the most important geopolitical and economic relationships of the st century that has ushered a new era of investment in mutual health development [ ] . china has become the world's second-largest economy and offered africa various based on win-win cooperation. traditionally, china is willing to work together with africa to achieve mutual benefits by taking advantage of its status as assistanceprovider in tackling infectious diseases of poverty [ , ] . furthermore, since africa is home to seven of world's ten fastest growing economies, chinese investments in the health sector in the continent can produce substantial financial gains and generate invaluable public health commodities and other goods that are much needed [ , ] . the need for an african centre for disease control and prevention (cdc) was recognized at the african union special summit on hiv and aids, tb and malaria held in abuja, nigeria, in july . the africa cdc has launched year with the establishment of an african surveillance and response unit, which will include an emergency operations center and exchanges on china's national disease surveillance and reporting system [ ] . currently, africa continent is experiencing a rapid economic growth, with a gross domestic product (gdp) of $ . trillion usd in and is estimated to increase to $ . trillion usd by . health-care spending rose from $ . billion usd in to $ billion usd in across african countries [ ] [ ] [ ] . the fact that sub-saharan africa accounts for % of the world's population and % of the global burden of infectious diseases caused by poverty, millions of people could be lifted out of poverty through bilateral trade and cooperation between china and africa. increasing and robust new commitments of outbreak and accounts for about % of all deaths recorded (a total of suspected cases, confirmed cases and deaths recorded since disease onset in august . in , us cdc estimated the yearly number of lf cases to be between , to , resulting in about , deaths across west africa. lf is endemic in most parts of west africa with sporadic cases occurring in other african countries every year. studies have predicted approximately % of liberia and sierra leone, % of nigeria, and % of benin to be at risk of lf through spatial analysis. in nigeria, approximately cases and deaths have been reported from to date. due to a paucity of data, the actual number of cases in other west african countries to date is still unknown. however, seroprevalence studies in the past have shown a prevalence of lassa igg antibodies in % to % of the general population in sierra leone and in guinea, and as high as % to % among inhabitants of tropical rain forest and % to % in hospital staff of gueckedou and lola prefectures in guinea. direct transmission from rodent to humans mainly occurs through inhalation of primary aerosols from infected rodent urine, ingestion of food contaminated with rodent excreta or by direct contact with broken skin. regional and nosocomial outbreaks of lf are commonplace in lf endemic countries and played a major role in recent outbreak. in nigeria, the lf outbreak has been estimated to have an overall case fatality rate of % and % in confirmed cases; the impact on healthcare workers due to inadequately equipped, weak preventive measure for hospital associated infections (hai) and well trained staff and facilities with poor laboratory and clinical management practices were the main reasons for a dearth of data. while there is no known vaccine for lf, early supportive care and treatment with ribavirin. prevention efforts include isolation of cases, implementing infection control measures such as barrier nursing supplies, rodent control and practicing adequate food hygiene (storing grain and other foodstuffs in rodent-proof containers) and personal hygiene. although treatment for lf is available, early diagnosis, prevention and prompt management of infection are necessary (table ) . these growing public health emergencies and challenges prompted a memorandum on building the africa cdc that was signed by the african union with two parties are including chinese and us govemrnents. this cooperation exploring ways of further cooperation and lessons learning from china's national disease surveillance and reporting system model [ , ] . based on a unified and integrated plan, china and us government are willing to leverage their respective strengths to support the african union in building this system, which will be the first regional disease surveillance system on the african continent from the ebola crisis. it is important to strengthen disease surveillance and monitoring efforts at the regional level in providing technical expertise and response coordination in future health emergencies, address complex health challenges, and build needed capacity responses, responsible for disease surveillance, investigations, analysis, and reporting trends and anomalies. this is a landmark event in african ownership of improving health across the continent. the us cdc looks forward to engaging in this partnership for many years to come to advance public health across africa and global health security [ , ] results from the first and second china-africa ministerial health development forum held in beijing, china and cape town, south africa in and , respectively, showed that china-africa health development partnership had entered a new collaborative paradigm with great global health opportunities [ , , ] . chinese and african health ministers have adopted a declaration to increase access to facilities, medication, health workers and training, linking chinese scholars with those in africa into shared responsibility and global solidarity [ ] . importantly, china-africa collaboration in health development will use "one health" approach to set the collaborative priorities, such as developing innovative information and communication technology for health, building regional surveillance systems, improving the core capacities of international health regulations and enhancing the using regulation of traditional medicines, etc [ , , ] . the significance of africa-china cooperation health development initiative milestone was the broad consensus mou aimed to support the establishment of africa cdc signed on april , as part of the agreement and of the pledge made at the summit that was held under focac in johannesburg, south africa december [ ] . this laudable mutual commitment was realized through the full operationalisation of the africa cdc in early supported by the chinese government, including providing infrastructure construction, equipment, information system, expertise, and professional training, etc. as well fostering continuous strengthening african states public health prevention and control system under the chinese supports are also provided through comprehensively capacity building (e.g., staff, postdocs and students) and providing technical assistance and technology transfering to africa cdc sub-regional centres. the benefits of the translation of the immense mutual public health priority aligns "africa union health vision " in the fields of infectious diseases of poverty surveillance and elimination, emergency preparedness timely response to early alert and risk communication capabilities against public health emergencies and disaster crises events. previously, china has already provided two million us dollars cash aid for the africa cdc in terms of capacity building and the on-site chinese experts visit for the regional collaboration with other partners' support [ ] . africa cdc has now developed a five year strategic plan to improve surveillance, emergency response, prevention and resilience against infectious diseases threats and outbreaks, man-made and natural disasters, antimicrobial resistance and chronic diseases public health events of regional and international concerns. africa cdc focus on strategic priority areas and innovative programs aiming at improving evidence-based decision making and practice in event-based capacity development for surveillance, disease prediction, and improved functional clinical and public health laboratory networks and actions in minimizing health inequalities, and promoting quality care delivery, public health emergency preparedness and response best practices in achieving regional [ , , ] . africa cdc collaborating sub-regional centres in five countries provides an opportunity for effective collaboration, integration and coordination in harnessing existing public health assets, epidemiological surveillance, strengthening existing networks of quality laboratories for early detection and response. infectious public health preparedness and emegergency response cannot deliver effectively if we do not implement "one health and biosecurity" approach bringing human, animal and environmental health. building evidence-based and adequate capacity building need to support integrated "one health" surveillance, laboratory systems and networks, emergency preparedness and response, and public health research for evidence-based heath programing and ample resource allocation. greater commitment to strengthen local and regional operationalization of integrated disease surveillance and response, public health systems and core capacities have been documented to critically address public health emergencies, biosecurity and disaster risk across the continent. national and regional public health emergencies, biosecurity surveillance, preparedness, rapid response, and recovery policy and strategies are robust and sustainable assets for socioeconomic transformation in line with africa health strategy ( - ), the africa union agenda and in attaining sdgs [ , , , ] . firstly, developing innovative information and communication technology for health will provide opportunities to avert thousands of deaths and disability by improving access to good-quality essential drugs, by increasing coverage of vaccines immunization and use of other pharmaceutical and medical commodities nationwide [ , , ] . in addition, leveraging on the unique "one health" approach to transform health care and health policy and to prioritize collaborative programs can be extended from infectious diseases to maternal and child health and health disparity in the poorest populations in africa [ , [ ] [ ] [ ] . secondly, building regional surveillance systems is another way to enhance the local health system. the importance of implementing a local and national "one health" policy and programs holds tremendous prospects, such as co-tackling the epidemiological and environmental challenges, and accelerating in the transition from control to elimination of infectious diseases under china-africa collaboration [ , ] . furthermore, it has potential to revolutionize national health systems, policies and strategic priorities and the patterns in health financing and resources allocation of african countries that require careful understanding of the local context of diverse stressors and drivers [ , ] . these will continue to dominate the performance and effectiveness of "one health" in threats and epidemics prevention strategies and policies on healthcare and health outcomes. thus, assessing health impact especially how greenhouse gas and ozone emissions, rising temperature and environmental pollution resulted in climate change impacts to health ecosystem, such as population movement, animal trading and ecology of vectorborne disease and ill health, aging, chronic disease, drug use and domestic violence, inequity and poverty [ ] . thirdly, improving the core capacities of international health regulations is the sustained efforts to improve the human welfare. for example, china's response impacting the global health fund (e.g., malaria, hiv/aids, schistosomiasis, ebola, influenza, tb, hepatitis, etc.) has shown robust global health leadership engagement [ , , ] . the leadership reflected in the strategic mobilization and investment of resources fostering more easily accessible, availability and cost effectiveness of prevention and treatment interventions to resources limited countries including african countries [ ] . the growing mutual china-africa win-win collaboration spans to technical expertise, technology transfer and capacity development using scientific and advanced methods to tackle the disease, and have enhanced their commitment to respect the dignity of the people such as chinese ebola outbreak emergency response in west africa. fourthly, enhancing the use and management of traditional medicines could improve the community involvement in health care and extend the trade among countries. so far, trade between china and africa is projected to reach $ million usd a year by . increasingly, embracing "one health" strategy to increase universal coverage of healthcare is significant as sharing china's rich expertise and lessons learnt in strengthening health systems and tackling public health burden both in china and africa communities. thus, africa has the opportunity to improve capacity of community health workers to reach remotes rural communities living beyond the margins of traditional health care systems [ , ] . therefore, china's advancements in research and development, technical and scientific capacity transferring can support african next generation of proactive scientists to develop more sensitive simplified diagnostic tools and reduce the costs of laboratory diagnosis and medical equipment. furthermore, research and development (r&d) is needed in examining the biological mechanisms of stressors or risk factors exposure and health effects, assessing evidence-based mitigation or adaptation interventions and benefits [ , , ] . innovative solutions and breakthroughs in human-animal-environment fields would not only enable africa to meet its own growing needs, but also support integrating health systems, including strengthening the capacities of laboratory diagnostics and medical care, as well as establishing the china-africa platforms that could generate evidence-based low-cost, available and easy-to-use health packages and solutions for the reduction of public health burden. the present paper has analyzed the values of implementing national to regional "one health" strategy for dealing with human, animal and environment related public health threats, diseases outbreaks emergencies and disaster risk challenges, and promote healthy mitigation measures and resilient management approaches in advancing targeted local, national and global health agenda. also, understanding how to develop, package and implement evidence-based and sustainable "one health" approach needs partnerships and investment for strategic priorities and resource mobilization. in addition, it also needs better financing mechanisms and participatory coordination in building capacity and technical assistance, monitoring, performance and effectiveness metrics evaluation for one health indicators. understanding the foundation of "one health" strategy in china-africa public health needs and challenges although significant progress has been made in improving health and safety of vulnerable population in low and middle-income countries (lmics), there is growing unprecedented public health emergencies crises due to natural disasters (such as disease outbreaks, floods, climate change, droughts and mud-/land-sliding) and man-made disasters including armed conflict and resulting forced refugees and displaced populations in lmics and mainly in africa as well as china. these have been resulting in significant direct and indirect health impacts including limited access to food, clean water, medicines, pre-existing mental health and other health services. conflict-affected countries have not achieved a single millennium development goal and have significantly higher maternal and infant mortality rates compared to stable and peaceful countries. natural disasters affect nearly million people each year, with a disproportionate effect on populations and environment. there is also limited quantity of highquality and integrated research to build evidence "one health" approach response. for example, recent emerging zika virus is known to be circulating in latin america, america, africa, asia-pacific and middle east regions due to climate change and rapid urbanization, intense regional and global travel and trade impact on zika virus risk transmission and documented congenital complications on fetal and maternal health. efforts to strengthen regional and global public health emergencies surveillance and preparedness should be maintained in order to better characterize the intensity of aedes and culex vectorial capacity, asymptomatic or syndromic viral circulation and geographical infection spread, epidemiology and laboratory monitoring of zika virus related complications in vulnerable settings. we found that most existing and emerging infectious diseases of poverty and chronic diseases public health programs are based more on top-down and anecdotal experiences rather than accurate research in fostering an integrated humananimal and environment or "one health" community practice in most vulnerable settings in africa and china (table ) . "one health" approach was officially adopted by international organizations and scholarly bodies in in response to the growing global human-animal and environment inter-dependence challenges and issues including climate change which needed new approaches. in such, "one health" broader interconnections understanding offers tremendous advantages and manifold benefits in tackling emerging zoonotic diseases and chronic diseases to disaster risk consequences, but also in improving safety health of people and animals, and safeguarding environment against pollutants and pollution. it aims to enhance across disciplinary and interagencies assessment complex including human-animal health systems vis-a-vis environmental and climatic determinants of health, development of contextual health or disease detection and surveillance-response systems, data sharing and communication; partnerships and mutual learning for positive transformation and behavioral changes outcomes. hence, strengthening firmer foundation in building evidence-based integrated healthy approach decision making, health programming and actions plans implementation, training and research practice to community-based programs ownership, shared values and experiences in integrated cost effective and beneficial china-africa "one health" strategy initiatives for mutual wellbeing and economic prosperity. prioritizing "one health" approach in emerging and current infectious diseases public health emergencies and disaster risk reduction is essential in attaining the regional africa union and global health agenda promises and benefits. it requires promoting and implementing evidence-based, effective and sustainable national "one health" strategy advocacy and mitigation strategies in most africa countries and worldwide [ ] [ ] [ ] . strengthening evidence-based, consistent and reliable community, national and regional 'one health' and biosecurity people's medical publishing house co., ltd. partnerships, leadership, road maps commitment, approaches and strategies is a crucial for zoonotic diseases threats and outbreaks public health emergencies and other disasters risks humanitarian crises. integration "one health" principles and frameworks in health and relating multisectorial units or agencies planning and actions plans in generating comprehensive, consistent and real time knowledge and information in guiding evidence-based decision-making policy and participatory commitment and investment [ , , ] . articulated interest and reliance of all stakeholders will cover communities and public articulated actions in preparedness and response to climate changes, infectious and zoonotic threat and epidemics public health burden has provided [ , , ] . the extent and nature of "one health" approach through political engagement and funding is critical in advancing community social mobilization and awareness on "one health" strategy integration in public health systems and primary health care. the needs and value is prerequisite in sustainable public emergencies and disaster risk reduction priorities, preparedness, preventive and control programs and activities. while, providing the enabling health-animal and environment interface biosecurity and protection of legislative and technical assistance support to policy makers, planners and implementers including the local vulnerable communities in transforming contextual positive knowledge, behavioural and attitudes changes [ , ] . understanding the climate change, global migration and country-specific complexities of emerging and current infectious diseases of poverty is needed in tackle operational programs challenges and bottlenecks, improved sustained control into elimination. for example national immunization programs hesitancy and resistance issues, such as misconceptions and mistrust or fear, weak coverage and non-adherence, persistent resurgence of zoonotic threats and emerging epidemics, continue to place a huge toll of maternal and child health morbidity and mortality on burden and coupled with the rising trend of chronic diseases related inequities and poverty vicious cycle [ , , , , ] . building china-africa "one health" strategy partnerships, frameworks and capacity development china's global health approach is an unique and distinctive path. this approach based on contextual policies and realities-based on their history, driveninter sectoral and multidisciplinary government related ministries strengthen health systems in different african countries [ , , , , ] . there is a steadily growth in depth and strength of china's global engagement and collective participation in fostering global health agenda through china-africa health development strategies. event-based preparedness and transparent support management and technical assistance on transferable chinese lessons in infectious diseases elimination and eradication including measles, filariasis, schistosomiasis, malaria, sars and ebola, etc. for example, the china-tanzania pilot project of community-based and integrated malaria control strategy and applications funded by china-uk partnership aimed at assessing the feasibility and transferability of chinese malaria skills in strengthening malaria health education, awareness knowledge and access to vector control interventions (e.g., rdt, llin, acts) to reduce the risk of malaria infection in tanzania [ , ] . moreover, in the absence of specific ebola infection treatment, the partners or organizations, including african governments, who, the gavi alliance and "ebola ça suffit ring vaccination trial consortium" should accelerate on joint consensus for the adoption and "expanded access" to proven efficacious and safe rvsv-zebov vaccine ring ebola immunization strategy implementation to boost immune response and protect vulnerable populations and global travelers from potential ebola outbreaks [ , , ] . china-africa mutual and comprehensive partnership in health and pharmaceutical has been encouraging and promoting the use of community-based health services; and increasing government investment in public health interventions [ , , ] . china has been very supportive on african countries' efforts in building medical facilities and health service. for example, in , the chinese government constructed medical facilities and provided batches of medical equipments and supplies to african countries. chinese enterprises and nongovernmental organizations have helped african people get quality medical services by means of building and running hospitals, investing in pharmaceutical factories and localizing medicine production in improving health management and well-being, including maternal and child health, and emerging pandemic threat programs, etc. moreover, chinese medical assistance to africa has been sustained and operative win-win mutual support tailored to local settings, which could enhance research priorities in dynamic mapping of vectors and infectious diseases transmission with interaction of human-animal-environment, and provide evidence-based strategies in national or regional diseases control programmes and effective response packages [ , , [ ] [ ] [ ] . good progress remains in developing and implementing these policies and strategies coupled with shared lessons learnt and experiences against unprecedented infectious diseases public health emergencies and rising non-communicable diseases (ncds) challenges, such as obesity, cardiac arrest and stroke, hypertension, diabetes, cancer, kidney disorders and mental health, etc. there is a shortage of qualified health professionals at grassroots health facilities. it is also shortage in accessing to basic health control and elimination packages and service delivery including vaccine preventable diseases immunization programs coverage inadequacies in most rural and remote settings across africa compared to china, insufficient public and private sector funding to r&d on safety and effective vaccines or drugs against most emerging coupled with unattended public health diseases threats and epidemics impact preparedness, and strategies mutually gains and economic benefits [ ] . remarkable results and outcomes have been documented from chinese medical assistance in of african countries, ranging from health workers, implementers and policy-makers. capacity development and skills acquisition were achieved in over health-related training courses to , health implementers and health workers since . chinese medical teams friendship and health cooperation, including construction of ophthalmic center where more than , free cataract surgeries were completed in four african countries and construction of more than six other chinese medical hospitals in the last decades [ , , ] . it is also worth noting the robust and efficient participation and contribution of twenty-seven chinese provinces, autonomous regions and municipalities with accumulated more than , chinese medical workers in medical centers since , and currently over , medical workers are working in african countries. continuous support in building medical facilities, africa cdc reference laboratories per excellence and health service capacity has been appraised in embarking on assessing public health emergencies needs, risk factors and determinants in understanding the perception, knowledge, attitude and practice in evidence-based promotion of integrated "one health" approach and biosecurity decision-making approach. this also provide priority and targets, methodologies and programs through effective indicators surveillance and monitoring. for examples, chinese government dispatched over medical facilities and over batches of comprehensive medical equipment for early diagnostics and prompt treatment or response, and supplies across africa since [ , ] . chinese partnerships with local firms and communities have helped medical services delivery to remote and rural vulnerable populations through joint activities in building and running hospitals, investing in improving and scaling up localized production in pharmaceutical and biotechnologies industries in africa. in addition, we also recorded the establishment of more than clinics of standard traditional chinese medicine (tcm) integrated to africa traditional medicine (atm) [ , ] . in achieving universal coverage and healthcare for all, upgrading china-africa mutual health development cooperation and collaboration through independent and joint institutional research project and capacity development in health services delivery and in promoting science and technology capabilities, joint projects and activities have been increasingly developed and implemented. these projects and activities aim at tackling the persistent and growing burden of infectious diseases of poverty, maternal and child morbidity and mortality, and responding timely to the global health concerns and emergency response called on emerging threats and epidemics in the continent. some examples of the landmark achievements include the china-zanzibar and china-tanzania projects on sharing chinese lessons and experiences in infectious diseases to support schistosomiasis and malaria prevention and control in african countries respectively, as well as chinese maternal-child heath safety and children nutrition, dissemination and transfer experiences in ghana [ , , ] . furthermore, china-comoros support to national malaria elimination that led to interruption of transmission and reducing in malaria mortality to zero in the last eight years in comoros [ , , ] . likewise, understanding strategic public health financing and human resources systems capacity is necessary in promoting uptake and efficiency of chinese global health initiatives and innovations in strengthening healthcare delivery system and quality outcomes in lmics including africa, asia-pacific, middle east and latin american countries. strikingly again, during the west africa ebola outbreaks in - , the chinese assistance in response valued at $ million usd and more than , experienced medical professionals were deployed in the frontline affected and neighboring communities to combat and contain the rapid spread of the ebola virus epidemics [ ] . in addition to the mobile biosafety laboratory, china also built permanent and well-equipped public biosafety laboratory in seirra leone and dr congo to improve the national capacity to detect, prevent and respond to future threats and epidemics. over batches of public health, clinical medicine and laboratory experts were dispatched in african countries in scaling up public healthcare delivery capacity and training of health workers and communities in risk assessment, communication, and response measures in effective ebola, malaria, schistosomiasis prevention and containment, amongst other shared responsibility and mutual commitment [ , , , , [ ] [ ] [ ] . future expansion of china-africa health development initiatives offers immense opportunities in increasing mutual benefits and growth to both continents' several domains not only limited to health, technology and trade. the scale and sustainability of existing and forthcoming programs and plan of actions will require aligning of national priorities and defining contextual performance and effectiveness indicators, but also mutual respect and trust, accountability and transparency with good governance and proactive stewardship. it is imperative that efforts should also be made in strengthening evidence-based translation to the benefits of vulnerable populations and global community through sharing of lessons learnt and care knowledge experiences and information for all generations in combating infectious diseases and rising burden of noncommunicable diseases. fostering health systems preparedness and smart response against emerging and re-emerging threats and epidemics chinese and african rapid economic growth and the importance of strengthening the local and national public health laboratory systems in both continents have been recognized in tackling the rising healthcare needs, challenges and issues [ , , ] . globalization of travel and trade is ever increasing local, national and global emerging and re-emerging infectious diseases threats and their impacts on human and animal health. resolving the persistent and unprecedented rising of emerging and reemerging epidemics, and new priorities of ebola, zika, hiv/aids, tuberculosis, malaria and neglected tropical diseases (ntds) requires collaborative and mutual cooperation with governments, bilateral and multilateral initiatives, including boosting private-public partnerships, regional and international organizations in achieving the global health security threat and agenda [ , , , , ] . for example, china has dispatched more than , medical experts to resist west africa ebola epidemics through contributions to coordinated international emergency response efforts that helped to contain ebola virus transmission dynamics and spread that retrieved lives of over , people [ , , ] . similarly, zika virus belongs to the family flaviviridae, genus flavivirus, and includes africa subtype and asia subtype. it is a mosquitoborne virus primarily transmitted by aedes aegypti mosquitoes, sexual transmission; blood transmission and mother-to-fetus transmission have been also reported. zika virus can go through blood-brain barrier and infect central nervous system. symptoms are generally mild and self-limited, but recent evidence suggests a possible association between maternal zika virus infection and adverse fetal outcomes, such as congenital microcephaly, as well as a possible association with guillain-barré syndrome. in absence of safe vaccine or effective antiviral zika medication for prevention and control zika virus infection, early laboratorial diagnosis includes nucleic acid detection, serological test, and isolation of virus and epidemiology and clinical risk assessment and syndromic surveillance is crucial [ , , ] . nevertheless, there remains a need to build a platform with function of effective surveillance, recovery, preparedness, consultation and communication, and to share surveillance based on the principle of sincerity, real time problem-solving and results-giving, and good faith towards collaborative global health solutions [ , [ ] [ ] [ ] . fostering surveillance capacity in laboratory, clinical, veterinary and allied health sciences in the africa continent are critical to overcoming the growing burden of diseases and ensuring a healthy future of its citizens [ , ] . meeting the urgent growing healthcare needs in africa requires strategic and technical approaches in the development and integration of sound and harmonized regulatory systems for diagnostic products, new drugs and vaccine r&d. while reinforcing the national and international public health laboratories networks are able to improve collaborative and participative early disease detection, early warning and surveillance research in guiding proactive vigilance and smart response activities. effective good governance and leadership coordination of sustainable strategies on emerging outbreak preparedness and response capacity is necessary towards the transformation from traditional to modernized digital laboratory systems in timely and effective quality service delivery. however, the need for laboratories quality improvements and accreditation of methods, tools and programs are critical in upholding the gains preparedness, and emergency response in various infectious diseases programs and strategies should be supported through both national and international initiatives. bilateral and multilateral cooperation with the world bank, un and who, global fund to fight aids, tuberculosis and malaria, worthy philanthropic individuals and organizations efforts can enable country to be ready and capable of early detection, prognosis, prevention, and smart response or management in any detrimental natural or man-made epidemics eventuality, while facing operational challenges and setting new research priorities [ , , , ] , for contextual "one health and biosecurity" programs, are also need to be supported with appropriate regulations and guidelines. there is an urgent need to invest in basic and operational research on climatic, ecological and evolutionary changes for understanding and forecasting persistent and future emerging threats dynamics and epidemics. timely evidence-based translation into policy programs and interventions is imperative to defeat the budding threat and burden through coordinate robust actions and better stakeholders leadership in response advocacy and mitigation in line with the paris climate change declaration in december, [ , ] . fostering integrated approaches with cuttingedge inter-sectoral and trans-disciplinary partnership is also needed evidence-based nationwide scaling up contextual surveillance and response capacity. moreover, with improvement of targeted strategies to deal with emerging outbreaks and infectious diseases of poverty elimination, understanding human-animal interface with increasing urbanization, globalization of trade and travel are necessary. hence, china-africa "one health" strategy sustainable implementation and alignment with local and national priorities hold great promises. integrating collaborative human-animal-environmental projects and programs have substantial prospects in increasing local and national food production and global food security [ , ] . this is critical in averting or reducing the persistent malnutrition, under-nutrition and related health complications and diseases (e.g. malnutrition linked kwashiorkor or rickets, obesity, typhoid, diarrhea, dysentery) resulted in children and youth developmental retardation, poor educational performance, poor quality of life and living including high daly and low qaly short life expectancy, worsening the vicious cycle of poverty and premature death documented in africa countries [ , , , , ] . similar high public health challenges and burden in africa were recorded in china before s, mainly in chinese rural communities circumventing with the implementation of the chinese rural cooperative medical insurance schemes. however, more investment is still needed in achieving food autosufficient and balanced food and nutrition/diet for all in both continents [ ] . developing and integrating climate changes resilience , mitigation and adaptation measures in allied health programs is vital in protection, conservation and management of the adverse socio-demographic, ecological, health and economic effects of greenhouse gas emissions and changes consequences, and in securing the future benefits of green and eco-friendly environment. the value of china-africa "one health" strategy implementation financial support from governments and various levels, advocacy and social mobilization to develop supportive community environment for infectious and emerging zoonoses threats and epidemics in population-based public health control and elimination interventions is imperative through implementation of evidence based and cost-effective "one health" surveillance and response strategy, in order to integrate human, animal, and environmental landscape, continue health education promotion, improve awareness and quality public health service delivery performance and effectiveness metrics across africa. enhanced disease surveillance response, community capacity development and strain capacity can provide significant opportunities in health education and promotion, shared responsibility, positive behavior changes and best practices by different health facilities, training health practitioners of diagnosis, treatment and rehabilitation services. identification of local and national health needs and evidence-based effectiveness of "one health" solutions are urgently needed to improve appropriate and sustainable resource development policies and strategic programs across africa. such new partnership initiatives linked to china belt and silk initiative action plan should attract more indigenous and international partners and stakeholders, more qualified multidisciplinary professionals to work, communicate and share experiences and lessons collectively. building local and national trans-disciplinary and trans-sectoral research teams towards improved understanding the genetic and molecular mechanisms of invasive pest and drug resistance, and control of complex disease systems and in strengthening continuous improvements of human, animal, ecosystem health and well-being [ ] [ ] [ ] [ ] . robust evidence in comprehensive control for multiple risk factors including health guidance on diet, fitness activity and promoting individual and community self-management model is important to services by general practitioners and mainly in translational research directed toward sustainable development activities and global environmental health. to support integrated veterinary, medical and ecosystem education, and to provide more professional career development opportunities, the governments need to continuously increase its investment in public health intervention programs and financial support to health insurance schemes. increased funding from both central and local governments needs to be directed to the underdeveloped regions and poorer rural areas to support global and national programes on infectious diseases of poverty and sustain control and elimination agenda for emerging epidemics tackle maternal and child health challenges, improve ncds mitigation interventions, and set up better health insurance schemes. in addition, it is equally important to strengthen monitoring of the use for public health interventions. "one health and biosafety" systems research projects development and implementation are also urgently needed in improving training programs and educational empowerment in guiding human-animal health and environment programming and technical assistance. addressing the existing and unprecedented public health emergencies or disaster risks requires optimizing the "one health and biosecurity" targets and interventions which will benefit indicators metrics monitoring in routine public health programs and humanitarian emergencies crises response [ , ] . there is need to promoting "one health and biosecurity" youths voices in healthy and ecofriendly "one health" community advocacy, engagement and participation. strengthening and sustaining "one health and biosecurity" strategy will improve the cost-effectiveness surveillance and communication interventions through continuous awareness, and knowledge improvements for the overall china-africa and global health security benefits [ , , , ] . robust and sustainable leadership commitment and investment is needed in integration of "one health" and global health security. advocacy and mitigation programs is needed in china-africa health development initiatives. to establish public emergencies indicators and metrics for early and timely community engagement and effective risk communication, following actions need to be handled to achieve sdgs and global health agenda: ( ) community-based partnerships and programs ownership, ( ) assessment for evidence based "one health", ( ) identification of the various stressors or risk factors, ( ) programmatic and proactive development and implementation of appropriate and sustainable "one health", ( ) resource mobilization mechanisms and solutions based on animal-humanenvironment interface challenges and impacts surveillance, preparedness, and timely collective response to public health threats and humanitarian emergency crises. china-africa health development initiatives: benefits and implications for shaping innovative and evidenceinformed national health policies and programs in subsaharan african countries enhancing collaboration between china and african countries for schistosomiasis control china-africa cooperation initiatives in malaria control and elimination establishing the africa centres for disease control and prevention: responding to africa's health threats tackling the challenges to health equity in china china's distinctive engagement in global health implementing a one health approach to emerging infectious disease: reflections on the sociopolitical, ethical and legal dimensions one health: an opportunity for an interprofessional approach to healthcare new orientation for china's health assistance to africa elimination of tropical disease through surveillance and response global implications of china's healthcare reform rift valley fever epidemic in niger near border with mali. the lancet inf diseases deciphering emerging zika and dengue viral epidemics: implications for global maternal-child health burden joint china-us call for employing a transdisciplinary approach to emerging infectious diseases china harvard africa network (chan) team. china, africa, and us academia join hands to advance global health china-africa cooperation initiatives in malaria control and elimination global health security: the wider lessons from the west african ebola virus disease epidemic one health: the hong kong experience with avian influenza genetic diversity and evolutionary dynamics of ebola virus in sierra leone building international genomics collaboration for global health security china's role as a global health donor in africa: what can we learn from studying under reported resource flows? the ebola threat: china's response to the west african epidemic and national development of prevention and control policies and infrastructure china's distinctive engagement in global health china takes an active role in combating an ebola outbreak: on-site observations and reflections from a chinese healthcare provider schistosomiasis control: experiences and lessons from china a strategy to control transmission of schistosoma japonicum in china schistosomiasis and water resources development: systematic review, meta-analysis, and estimates of people at risk surveillance-response systems: the key to elimination of tropical diseases rebuilding transformation strategies in post-ebola epidemics in africa evidence on public health interventions in humanitarian crises thanks to nipd, china cdc, shanghai, and universite des montagnes for the enabling environment to complete this review. data are freely available and accessible. the authors have no conflict of interests. not applicable. key: cord- -vwxbo b authors: taylor, allyn l; habibi, roojin; burci, gian luca; dagron, stephanie; eccleston-turner, mark; gostin, lawrence o; meier, benjamin mason; phelan, alexandra; villarreal, pedro a; yamin, alicia ely; chirwa, danwood; forman, lisa; ooms, gorik; sekalala, sharifah; hoffman, steven j title: solidarity in the wake of covid- : reimagining the international health regulations date: - - journal: lancet doi: . /s - ( ) - sha: doc_id: cord_uid: vwxbo b nan amid frenzied national responses to covid- , the world could soon reach a critical juncture to revisit and strengthen the international health regulations (ihr), the multilateral instrument that governs how states and who collectively address the global spread of disease. , in many countries, ihr obligations that are vital to an effective pandemic response remain unfulfilled, and the instrument has been largely sidelined in the covid- pandemic, the largest global health crisis in a century. it is time to reimagine the ihr as an instrument that will compel global solidarity and national action against the threat of emerging and re-emerging pathogens. we call on state parties to reform the ihr to improve supervision, international assistance, dispute resolution, and overall textual clarity. first, the covid- pandemic highlights longstanding challenges in the identification of a public health emergency of international concern (pheic). the ihr obliges states to notify who of any event that may constitute a pheic within h after public health authorities' assessment. evidence indicates that some public health authorities in wuhan, china, suspected what later became known as severe acute respiratory syndrome coronavirus for several weeks before who was privy to the information. without legal authority to independently visit china and review the outbreak situation, who faced a barrier in mounting a cogent global response. in a reimagined ihr, states should allow for information to be received from non-state actors without being subject to verification from the state in question, as currently required by the ihr. moreover, national accountability should be strengthened by mandating independent experts to conduct missions to states so that they can review potential outbreak situations. arms control treaties bear the strongest examples of such inspection mechanisms, but they have also been wielded in other realms of global health, principally the international drug control regime. the concrete links between infectious disease control and global security provide a compelling rationale for an inspection mechanism that encourages states to be more forthright and accountable in reporting a potential pheic. relatedly, the process for declaring a pheic must be revisited. in a reimagined ihr, states should call for transparency in the deliberations that lead to a pheic, by publishing, for example, the transcript of discussion that led to the declaration of a pheic. transparency would enhance accountability in the ihr process. furthermore, states should consider replacing the rigid binary pheic architecture, whereby the decision is either no pheic or a pheic, with an incremental mechanism that would enable intermediate stages for ihr-based alerts and guidance. this change would enable greater flexibility and global coordination in responding to disease outbreaks as they unfold. second, covid- has shown that all states must invest more domestic resources in their public health systems. following more than a decade under the revised ihr, only a third of countries meet the core capacities of public health systems required therein, impacting countries' abilities to prevent, detect, and respond to disease outbreaks and putting "the whole world at risk". however, even in states where public health core capacities are deemed strong, public health responses to covid- are woefully inadequate. strengthening public health core capacities in all countries demands the concretisation of global solidarity and international support in our shared vulnerability to pathogens. states should consider bolstering the ihr provisions for international assistance, including incorporating a financial mechanism to assist lowincome countries in building and sustaining required capacities. to ensure accountability for national capacity building, states should integrate an effective reporting mechanism to monitor implementation of ihr obligations. robust reporting procedures generally require states to submit periodic national reports on the measures adopted, progress made, and problems encountered in the implementation of a treaty and, crucially, to incorporate some type of independent review. periodic reporting procedures assist states in identifying and alleviating obstacles they face when implementing commitments, without criticising their performance. international monitoring is crucial for treaty implementation in a wide range of fields and can be imagined as a key mechanism to catalyse cooperation in a post-covid- world. the absence of any provision for such monitoring in the ihr hampers its effectiveness and relevance. third, the covid- pandemic confirms how disruptive health measures can be for trade, transport, and economic activities. [ ] [ ] [ ] disputes over the legality of such health measures are likely, and agreed mechanisms to settle them would prevent political tensions from becoming disruptions. some disputes lend themselves to longer judicial processes, but many would benefit from prompt and practical mechanisms of resolution. the ihr provides a range of options, but these have never been publicly used. multilateral dispute resolution processes, including consultation forums among concerned states and an active good offices role by the who director-general preceding the dispute resolution process, could provide pragmatic solutions. fundamentally, states must tackle the overarching issue of ambiguity in the text of the regulations in any future ihr reform process. the widespread lack of clarity with respect to key state obligations in the current ihr undermines compliance by producing a "zone of ambiguity within which it is difficult to say with precision what is permitted and what forbidden". there will soon come a time when negotiators will meet to reimagine the ihr or devise a new legal instrument to promote global cooperation to address infectious disease outbreaks and other global health threats. the challenge should be met head on, not squandered or hidden behind a veil of ambiguity so that a strengthened ihr is better equipped to respond to future global health challenges and acts as an instrument for global solidarity. alt was a legal adviser at who and a consultant to who on global health law matters. glb reports personal fees from who regional office for europe for consultancy on governance and procedural questions; the fees relate to a consultancy on the governance of the office and the procedures of the regional committee. sd is a member of the who research ethics review committee. me-t previously worked as a consultant to who on unrelated matters. ap reports grants and personal fees as past and current consultant to who on global and public health law matters, including the ihr. graduate institute of international and development studies who director-general's opening remarks at the world health assembly. world health organization who. international health regulations, wha . , nd edn. geneva: world health organization clinical features of patients infected with novel coronavirus in wuhan, china addressing the global tragedy of needless pain: rethinking the united nations single convention on narcotic drugs security council resolution transparency in ihr emergency committee decision making: the case for reform interim report on who's response to covid- global preparedness monitoring board. a world at risk: annual report on global preparedness for health emergencies rethinking pandemic preparation: global health security index (ghsi) is predictive of covid- burden, but in the opposite direction in: oxford handbook of united nations treaties trade set to plunge as covid- pandemic upends global economy global economic prospects effects of novel coronavirus (covid- ) on civil aviation: economic impact analysis the new sovereignty key: cord- - vd d authors: hinchman, angelica; ali, diab; goodwin, bailey w.; gillie, monica; boudreaux, jacob; laborde, yvens title: global health is local health: a multidisciplinary perspective of covid- date: journal: ochsner j doi: . /toj. . sha: doc_id: cord_uid: vd d nan in december , the novel coronavirus-severe acute respiratory syndrome coronavirus (sars-cov- )-likely originated from a wet animal wholesale market in wuhan, china. originating from hospitalizations for respiratory illness in the hubei province on december , , infections quickly erupted to confirmed cases by january , in provinces throughout china and to , cases by january , . [ ] [ ] [ ] the affordability and availability of modern travel, crowded airports, and the recycled air of planes aided in unprecedented geographic reach and rapid escalation of viral transmission. globalization, in combination with the prolonged incubation of covid- , its lengthy survival time on surfaces, and the extended period of viral shedding in infected persons, enhanced the virus's largely undetected proliferation. by january , additional cases were reported beyond china's borders in taiwan, thailand, vietnam, malaysia, nepal, sri lanka, cambodia, japan, singapore, south korea, united arab emirates, united states, philippines, india, australia, canada, finland, france, and germany. the virus spread beyond local and national borders. what was previously a vague and distant global health problem quickly became a local public health concern everywhere. by the end of march , new orleans, la, had emerged as the city with the highest fatality rate per capita in the united states. this fatality rate disproportionately affected african americans who accounted for % of coronavirus deaths in louisiana, while making up only % of the state's population. the heavy burden of noncommunicable disease in louisiana, compounded by recent social events in the city of new orleans, including the carnival season, catalyzed the rapid transmission of sars-cov- throughout the state. in this paper, we review the multidisciplinary impacts of the covid- pandemic across the healthcare system. from a local focus on new orleans to a global perspective, we relate how rapidly changing healthcare policy, evolving use of technology, and social media dynamics played roles in perception and response to the pandemic. we reflect on the perspectives of evolving national health policy, public health demands, impact on mental health, strain on primary and emergency care, and the emergence of telehealth on a global and local scale. the rapid escalation from the outbreak in wuhan, hubei province, china, to global pandemic in a matter of days presented a challenge for the coordination of a federal public health response in the united states. the federal government's response during the early days after the world health organization alert on december , consisted of evacuating american diplomats from wuhan, banning air travel from china, and preparing to repatriate americans from abroad while managing stirring fears at home ( figure ). [ ] [ ] [ ] the government's facilitation of communication between healthcare experts and the public during an emerging pandemic amplified an existing challenge in public health: finding a balance between informing the public of imminent health threats while preventing increased anxiety and panic in response to elevated risk perceptions. as us government officials struggled to keep up with the rapidly evolving data on covid- , a disjointed public health policy response resulted, leading to public distrust, panic, and polarized perceptions of the disease. as in china, delays in information sharing and guidelines by the us government created a window of uncertainty, providing the opportunity for social media platforms to assert themselves as primary news sources for the american people, resulting in rumors and misinformation being spread within the united states via social media posts and the sharing of obscure news outlets. , content-shaping algorithms that personalize the user experience, popular on websites such as facebook, compounded the cycling of misinformation, enabling public confusion, anxiety, and mistrust of the government. one outcome was the panic buying of toilet paper, hand sanitizer, antimicrobial wipes, and other goods during the early days of the covid- outbreak. [ ] [ ] [ ] public confusion was amplified by inconsistent information shared by us government representatives. on march , president trump announced a national -day policy of social distancing. six days later, the president tweeted that social distancing may be "worse than the problem itself." on april , although the president echoed recommendations by the us centers for disease control and prevention (cdc) for americans to don cloth face coverings while in public, he emphasized that these recommendations were temporary and voluntary and stated that he would not wear a mask himself. such communications led to the emergence of competing narratives surrounding how people should best protect themselves and others from the virus based on a patchwork of guideline interpretations. the contradictory information from government officials demonstrated the importance of having coordinated public health policy information and responses. the majority of covid- confirmed cases appeared to occur in patients to years of age ( . %), but the population group with the highest mortality are those ࣙ years old. preliminary findings from the china cdc show a positive correlation between age and fatality ( figure ). among , cases, confirmed covid- positive patients ࣙ years of age had a . % mortality rate. age is not the only contributing factor for increased mortality; preexisting comorbidities including hypertension, diabetes, cardiovascular disease, chronic respiratory disease, and all types of cancer increase the risk of fatality compared to having no comorbid conditions at all. however, these factors are not mutually exclusive as older patients are more likely to have one or more comorbid conditions. the state of louisiana is particularly at risk given the prevalence of comorbidities in the population. in the most recent census ( ), louisiana ranked th in overall health outcomes based on behavior, policy, clinical care, community, and environment ( figure ). in reports focused on particular conditions, % of adults were reported as having hypertension, . % with diabetes, . % with chronic obstructive pulmonary disease, and % with heart disease. [ ] [ ] [ ] [ ] the prevalence of these comorbid conditions makes the population of louisiana as a whole susceptible to poor health outcomes. in addition to the effect of comorbid conditions, preliminary data revealed race as a contributing factor in covid- cases and mortality. in louisiana as of early may, african americans accounted for approximately % of covid- associated fatalities ( figure ) . , statewide data showed that % of deaths occurred in orleans parish, where roughly % of the population is african american. , consolidated cdc data from states from the month of march showed that % of hospitalized, covid- -confirmed patients were black, while this group made up only % of the surrounding population. in new york city, both african american and hispanic covid- -related death rates outnumbered those of whites or asians. meanwhile, the american public media research lab independently began collecting racial breakdown data from the district of columbia and states and found alarming evidence of a % increased likelihood of covid- fatality among black patients compared to white, hispanic, or asian patients. an important note is that the collective data reporting on covid- are incomplete, as states are only reporting the racial breakdown on a portion of recorded deaths. this racial disparity is thought to be attributable to a combination of socioeconomic factors, including a long history of structural injustice and oppression in the united states that has resulted in social inequity, higher rates of chronic conditions, poverty, and unemployment among african americans. this sentiment is reflected in data demonstrating that african americans aged to years are twice more likely to die from heart disease, and, on average, develop heart disease at a younger age than white americans. this statistic is in addition to documented higher rates of hypertension, diabetes, cerebrovascular disease, asthma, and obesity in african american communities. furthermore, minority populations are more likely to work in the so-called essential labor sector as workers in healthcare, transportation, government, and food supply. one in african americans and in hispanics have a job that does not allow them to stay at home and social distance. , minority populations' ability to social distance is also impacted by the higher likelihood of living in multigenerational households and densely packed living situations. finally, african americans are more likely to report financial barriers to accessing healthcare. financial barriers may delay presentation, allowing case severity to advance and increasing the likelihood of intensive care unit (icu) admission. the racial bias, stereotyping, and prejudice known to affect quality of care by healthcare providers, as well as patient experience in the healthcare system, are also contributing factors. to further explore these racial and demographic disparities, more comprehensive research and data are needed to guide population-specific interventions and health policy. without these data, health officials and lawmakers will not be able to adequately address health inequities or understand the scope of the disparities. emergency departments (eds) and urgent care centers across the world are classically on the frontline of disaster and are where the first encounters with patients generally occur. as rumors mounted and anxiety built in the absence of communication from national leaders, eds were flooded by patients with covid- -related complaints, reaching a total of , , visits in the united states and peaking at , visits in week. with the influx of patients rushing to hospitals for care, resources were reallocated to address the dramatic increase in patient volume and to mitigate transmission within these facilities. healthcare institutions across the globe prioritized frontline emergency and intensive care departments to directly address mounting patient demands. resources, including personnel, were shuffled within systems, and elective and nonemergent procedures were canceled. these steps had the positive effects of distancing healthy patients from disease-laden hospitals, permitting the conversion of unused space to additional icu capacity, and conserving personal protective equipment (ppe), but the resource reallocation also left a void in the care of thousands of patients. as crowded waiting rooms devolved into vectors for viral spread with the surge of patient encounters, protective measures became necessary to decrease transmission among waiting patients. one hospital in taiwan implemented buffer areas to segregate patients based on risk. patients with fever and respiratory tract symptoms were categorized into high, intermediate, or undetermined risk groups and allocated to separate areas to minimize the potential spread of covid- throughout the hospital. patients were managed in these designated areas and transferred to isolation rooms for the collection of nasopharyngeal swabs. by establishing this protocol, the hospital was able to achieve a positive predictive value of . % for covid- infection in the high-risk area of the buffer zone. however, strategies such as these are hindered by time availability, lack of well-established protocols, and limited accessibility to ppe, further compounded by significant drops in ppe production in china. institutions compensated for the increase of patient needs by establishing call-in telephone lines to mitigate the brunt of public panic and minimize the burden on the ed. strategies evolved to keep healthier patients away from hospitals through the establishment of large-scale communication lines that encouraged home management of mild symptoms to limit transmission within healthcare institutions. ochsner health established a nurse-and medical studentrun call center to triage sick patients outside of the ed that eventually evolved into a platform for symptom monitoring of covid- -positive patients from home. integrating this call center into ochsner's covid- response plan enabled ongoing resource-sparing medical contact with a large patient population at one of the major hotspots for infection in the united states. despite the implementation of new hospital protocols in response to the covid- pandemic, the public's fear of waiting rooms as vectors for disease swelled, and ed attendance began to drop while the percentage of covid- associated illness continued to rise. noninfected patients began avoiding the ed out of fear of contracting the virus. as a result, care was delayed for some patients with potential health emergencies, further contributing to the escalating mortality observed in the united states. hospitals in other parts of the world have reported consequences of complex covid- protocols. a hospital in hong kong, china, has documented evidence of delayed primary percutaneous coronary intervention treatment of stsegment-elevation myocardial infarction, not only because of delays in seeking care but also because of institutional delays caused by new covid- safety protocols. although necessary to limit the transmission of disease, some emergency and triage adaptations have resulted in unforeseen consequences to patient care. new zealand and denmark had some of the earliest and most aggressive responses to the covid- pandemic. new zealand began mandatory quarantines for all visitors on march , one of the strictest policies in the world at the time, even though only cases had been documented nationwide. just days later, new zealand instituted a complete countrywide lockdown, including a moratorium on domestic travel. under these level restrictions, grocery stores, pharmacies, hospitals, and gas stations were the only commerce allowed; vehicle travel was restricted; and social interaction was limited to within households. denmark, which already has one of the world's highest functioning healthcare systems, had more than times as many beds with ventila-tors as it had patients hospitalized with critical covid- symptoms. additionally, because of the universal healthcare model in denmark, all treatment, including testing, was without cost to those who needed it. in contrast, the primary care system in the united states lacks a standardized healthcare unit. public and private outpatient practices vary in size and ownership, creating hurdles to identifying the problems covid- presented to primary care. the primary care collaborative (pcc) began conducting weekly surveys to try to identify the issues primary care workers were facing. on march , , the pcc published results from a survey of more than physicians, nurses, nurse practitioners, and physician assistants working in the primary care sector. survey responses indicated limited capacity for testing in the outpatient setting, which was compounded by the stress of addressing an abundance of patient concerns, challenges in limiting the exposure of healthy patients, and a shortage of ppe for both staff and patients. as the surveys continued in subsequent weeks, the stressors shifted to limiting routine visits and clinic staff absences because of illness or isolation. despite patients being receptive to telehealth visits, % of primary care workers who responded to the survey did not work at a practice that offered e-visits. interestingly, this number decreased to % by the next week, highlighting the rapid expansion of telehealth services. by week , more than , primary care workers from all states had responded to the survey, and the major issues impacting access to care were identified as disparities among racial minorities, patients with low income, and patients with no internet access. the adaptations to minimize in-person appointments created new challenges for treating patients with preexisting conditions and training patients and physicians in a new way of practicing medicine. the week survey showed that % of responders felt that patients avoiding or delaying care until after the pandemic will lead to non-covid- deaths, and % believed that patients will experience avoidable illness. in england, primary care physicians suspended routine checks for all patients > years nationwide. , similarly, primary care physicians in new orleans limited in-person visits and moved routine checks to telemedicine when possible. as a result, clinicians are having to learn new skills, platforms, and ways to care for patients. from a healthcare standpoint, pandemics cause a predictable surge in demand because of the infectious agent itself and because of the associated mass anxiety. the unfamiliar and mysterious nature of an invisible agent makes it seem "powerful, evil, and imperceptible." further, as misinformation rapidly spread, the pandemic had a profound behavioral impact, resulting in avoidance or anger, scapegoating, disruption of work-life balance, restricted activities, and substance use. factors such as the deaths of those seen as vulnerable, inadequate resources, paranoia, conspiracy theories, loss of faith in leaders and institutions, and the restriction of civil liberties all may have unforeseen impacts on downstream societal perception and social participation. , in new orleans, the compounded fears of infection, isolation, and quarantine, as well as resource shortages and scarcity, contributed to a heavy cognitive-emotional burden. vulnerable populations requiring additional mental health considerations include migrants and refugees, people with cognitive or mobility impairments, the disadvantaged and homeless, children and adolescents, pregnant and postpartum women, and people who depend on systems of care. people with preexisting psychiatric disorders, including those with addiction and substance abuse issues, are especially vulnerable, not only to the uncertainty associated with covid- but also to the potential to be more stigmatized and marginalized compared to their already problematic acceptance. at the end of march , market research by nielsen demonstrated a % increase in alcoholic beverage sales compared to the prior year, but only % of americans reported an increase in alcohol or substance use intake. , despite the predictable increase in the need for mental health support, resources were reallocated to support primary care and hospital settings to directly address covid- infection, leaving mental health services insufficiently prioritized in new orleans. the new orleans national alliance on mental illness (nami) chapter had to suspend all new patient intakes, psychosocial rehabilitation, community support, and education programs in the early stages of the pandemic with scarce virtual options to take their place. a few new orleans phone and virtual support groups have become available, including the #getyamindright virtual support group hosted by the institute of women & ethnic studies, the nami new orleans-associated survivors of suicide loss virtual support group, keep calm through covid crisis phone line providing mental health and substance abuse counseling services. however, these very few mental health resources adapted to address pandemic-relevant mental health may be underprepared for the compounding roles of providing specialized care to those with preexisting mental health disorders, substituting for preestablished community support groups, and handling pandemic-related psychiatric problems. both in new orleans and worldwide, substantial increases in anxiety and mood disorders, substance use, domestic violence, and child abuse appear to be likely as schools remain closed. the downstream effects of this mental health emergency are difficult to predict. telemedicine was initially developed as a tool to address resource-limited populations that lacked accessibility to healthcare centers. it has increasingly become a focus of research in all health sectors globally, with the original emphasis placed on its use in psychotherapy and mental health services. prior to the covid- pandemic, telehealth was not recognized or established as an integral part of the american healthcare system and was accessible to only slightly more than institutions across the country. since the beginning of the covid- pandemic, the needs for isolating patients, limiting exposure, providing medical maintenance, and delivering essential care have highlighted telemedicine as a critically important solution for healthcare delivery. in addition to conserving resources, providing virtual care through telemedicine allows physicians to assess infected patients and patients under investigation without risking exposure to the practitioner, support staff, and other patients. as the supply of ppe, medical staff, and hospital beds dwindled, the importance of effective, resourceconserving measures shined a spotlight on telemedicine. now, more than ever, the global need for resource-sparing healthcare options is reflected on the local level. the united states has been slow to incorporate telehealth into its healthcare systems, unlike other countries such as china. however, sudden demands for a platform that enabled social distancing-compliant healthcare access accelerated the adoption of telehealth in the united states. the covid- emergency declaration allowed for enactment of an waiver under the social security act to expand medicare coverage to patients seen by video visit for any purpose. the waiver also allows for the prescription via telepsychiatry service of schedule ii to v controlled substances that previously required an in-person visit, thus giving patients covered by medicare access to medications without the risk of physical exposure in the office. this waiver bypasses major barriers to care, including limitation of services, range of treatment, and state-specific restrictions in licensing that stunted previous government telemedicine incentives. however, a gap remains for those covered by private insurance or medicaid, for whom this waver does not apply to date. in new orleans, telemedicine programs were adapted to address the needs of the pandemic. patients in high-risk demographic groups were targeted specifically for remote visits so that they could avoid going into clinics and hospitals. the majority of these targeted patients had low socioeconomic status, high comorbidities, and low technology literacy, and they were older in age. while telehealth options circumvent classic socioeconomic barriers to care, such as transportation and financial restraints, new barriers such as the inability to be trained on and navigate the telemedicine system, lack of access to smart devices, and inadequate wireless internet connections are obstacles in converting to a virtual visit system. inequities to accessing telemedicine services will need to be addressed in future health policies. existing social factors-such as psychological, cultural, health, and socioeconomic status-collectively contribute to the public perception and interpretation of risk in a pandemic. pandemic communications must balance public engagement to optimize a unified capacity for citizens to practice precautions that reduce transmission while also minimizing panic. a article analyzing the role of uk twitter in regard to information sharing during the h n pandemic found that the largest category of information users interacted with were resource information tweets that shared links or were descriptive in nature. in this category, news sources had significantly more engagement than health authorities. news publications have the power to sway public perception through tone and recontextualization of the information being shared. early sharing of information from public health officials may establish health authorities as the primary resource regarding health information, reduce public speculation and distrust, moderate public paranoia and anxiety, and unify public involvement in health initiatives such as social isolation. increasing public health awareness by providing information and promoting guidelines could facilitate compliance with government mandates. one example is to develop a list of recommended items and suggested quantities for a -week quarantine per household. this public health promotion could be extended to grocery stores, with the recommendation to assemble kits of items to minimize shoppers' time in public settings. overall, a prompt and aggressive approach to information sharing by public health officials could ease public anxiety and enable an organized public response to improve health outcomes in a pandemic. the covid- pandemic has affected all healthcare practitioners, including students. medical students across the united states in their final years of schooling, primarily working in the clinical setting, had their studies suspended to minimize their exposure to the coronavirus. these alterations may have a lasting impact on their careers. removal from clinical settings, suspension of away rotations, and canceled board examinations left many third-and fourthyear students without the opportunity to meet the standard requirements of the national resident matching program to secure an intern placement for the next year. at the ochsner clinical school in new orleans, as at several other us medical schools, third-and fourth-year students refused to be sidelined. despite a -week suspension of studies that removed students from their clinical rotations, approximately students volunteered during their reallocated vacation time to assist in the response to the pandemic. students volunteered at call centers, contributed to the development of louisiana's first rapid testing center, and acted as family liaisons/advocates to take some of the load off of physicians and nurses who typically fill these roles, thereby allowing them to focus on direct patient care. the need for public mental health support has been critically demonstrated during the covid- pandemic, revealing weaknesses in both public and private healthcare systems and the need for improved mechanisms for basic care and refill/delivery of essential psychiatric medicines. mental illness, already a barrier to traditional care because of its nature, was exacerbated by the isolation, anxiety, and compounded stigmas of the pandemic. the literature supports using a system of stepped care in treatment that involves the universal offering of effective, resource-conservative treatment and then advancing care as necessary based on individual patient needs. given the capabilities of telehealth, virtual platforms could be used for psychiatric telehealth consults and group visits in resource-limited settings. even if these recommended changes are implemented, the healthcare system will likely remain insufficient unless community support is also strengthened. the social distancing measures of the covid- pandemic resulted in a lack of programs that provided community support, rehabilitation, and therapeutic services. in conjunction with comprehensive telehealth programs, social media could be used to connect people to evidence-based mental health resources and healthy practices. these platforms could also integrate check-in functions; promote collective resilience in the face of community stressors; and improve systems of mental health surveillance, reporting, and intervention for the anticipated increase in domestic violence and child abuse during the covid- pandemic. further, nontraditional groups could be trained to provide psychological first aid, reinforcing the public's ability to check in with one another and provide effective support. these nontraditional groups can include community populations that have been well documented in studies of task-shifting in the global mental health literature (teachers, religious leaders, barbers) or could be those involved in healthcare (medical students, medical assistants, pharmacists, physical therapists). training an expanded range of multidisciplinary healthcare team members in psychological first aid could also help address the mental health burden these providers have as vulnerable populations themselves. covid- illuminated the need for increased understanding of the impact of collective community stressors on healthcare workers, as well as programs dedicated to optimizing the mental health of providers susceptible to both direct and vicarious trauma. telemedicine rapidly expanded to meet the demand of the covid- pandemic. however, many obstacles to care still exist, including health access inequity. patients without smart devices or internet access are unable to receive comprehensive, virtual care. this inequity is compounded by lagging health policy that historically has and continues to funnel funding for telemedicine into medicare-specific programs. while the population covered by medicare will benefit from access to virtual visits, this policy leaves those with private insurance, those covered by medicaid, and uninsured patients out of the picture. barriers also include reimbursement restrictions, licensure, credentialing restrictions, and broadband internet connectivity. reimbursement and licens-ing restrictions have been temporarily suspended to allow greater telehealth access during the pandemic. this suspension highlights the need for sustainable change to increase access. the goal is to have telemedicine systems in place and health policies that support their use and availability so that a fully integrated and stable system is available, and patients are comfortable using it as a primary source of care. preexisting limitations of healthcare access were compounded during the covid- pandemic by recommendations to avoid eds and efforts to decrease outpatient visits for patients with noncommunicable diseases. despite the increased availability of telehealth services, patients without internet access or smart devices cannot access this mode of healthcare effectively. because of the racial inequity in covid- cases and mortality, the need to address socioeconomic disparities affecting covid- outcomes is clear, especially in new orleans and other cities where preliminary data support this imbalance. to understand the breadth of the issue, the compilation of comprehensive nationwide data on the racial and socioeconomic breakdown of cases, complications, and deaths is imperative. these data can help guide population-specific interventions and health policy in preparation for future epidemics. with the suspension of nonessential work in states by mid-april, millions of americans lost their jobs and health insurance. in some locations, % of individuals obtaining assistance from soup kitchens and food pantries had never visited one prior to the pandemic. delays in business reopenings may lead to long-term repercussions in health and access to healthcare. in early april, the estimated unemployment rate was % (the highest rate of unemployment since the great depression), and million americans had applied for unemployment in the prior weeks. reduced access to care because of economic hardship increases the risk of disease, as classically, people of lower socioeconomic status typically have worse health outcomes than those in higher socioeconomic brackets. while incentives to protect the economy, such as lifting shelter-in-place mandates, may seem protective by increasing health insurance coverage, lifting isolation measures prematurely may risk a second wave of infection similar to the one that occurred during the spanish flu epidemic and further deplete the primary care system. the decrease in access to healthcare is also attributable to physician and medical staff shortage. the covid- pandemic has amplified the stresses of global physician shortages. a report from the association of american medical colleges identified a shortfall of , to , physicians during the prior decade. older physicians are being called out of retirement, and medical students in their final year of study are accelerating their graduation to expand the workforce and aid in the increasing workload in response to the pandemic. as more healthcare workers are infected themselves, the population continues to age, and the ripple effects of covid- impact the health of our nation, the burden on the healthcare system will continue to grow. the need for more physicians is undeniable, and this need must be reflected in the number of available residency positions. facing such shortages, we cannot afford to turn away educated professionals seeking training. in anticipation of new orleans reopening, ochsner health, in conjunction with the city of new orleans, began the first phase of a study to assess the covid- disease burden in the greater new orleans area. nontraditional testing centers were established, including one at the new hope baptist church, to increase access to testing in communities where people lack transportation to travel to established testing sites. selected study participants were tested for covid- using both nasopharyngeal swabs and serum antibody tests. these data, combined with previously documented cases, will be used to gain insight into the extent of the spread of covid- prior to the reopening of the city. increasing the access to testing among underserved populations could facilitate quarantine measures and expedite connections to care prior to an escalation of symptoms. in addition, outreach programs are targeting african americans to help address healthcare disparities. the louisiana perinatal quality collaborative (lapqc) has a dedicated health equity task force focused on addressing health inequity associated with provider practice. the lapqc has implemented unit huddles that allocate time specifically for participating teams to discuss health equity in the context of covid- and create space for the discussion of ideas to minimize the impact of implicit bias in practice. ochsner medvantage clinics are creating healthcare access equity by removing financial barriers to care. these ochsner-based clinics work primarily with patients who are considered high risk for hospital readmission and for poor outcomes with covid- . as a result, services have been focused on supporting high-risk populations via telemedicine with waived copay fees. when normal operations resume, medvantage clinics will offer home visits and lyft health rides to patients who are unable to access transportation or who are physically unable to come to the clinic and will focus on addressing goals of care, including advance care planning. institutions and providers can take further action to tackle disparities in health by increasing awareness of implicit bias and how it can affect practice. using tools such as those provided by the government alliance on race and equity can help identify and address racialized health inequities. race-driven health disparities are prevalent throughout the american healthcare system and will require a unified response guided by comprehensive data to eliminate them. the word global in the term global health refers to the scope of current issues, not their location. global health problems are too often portrayed as the distant issues of others-until they reach our doorstep. globalization has made all populations vulnerable to disease, exploiting our interdependence with a clear predilection for the socioeconomically disadvantaged. innovative primary care solutions must address community inequity and the social determinants of health, clearly illustrated in louisiana where african americans account for the vastly disproportionate majority of covid- -associated cases and fatalities. solutions should not be limited to the pandemic response but necessitate adaptation from the clinical to political level. during the pandemic, men-tal health has been unprioritized despite a rapidly increasing need for resources and initiatives that support collective resilience, the minimization of stigma, and the feeling of social closeness while physically distant. the unstable and unsupported telemedicine infrastructure has been forced to expand without proper patient or healthcare provider training, understanding of outcomes, or systems in place for dissemination or optimization. this infrastructure must become an integrated, fluent system prepared for disaster response, while also optimized for routine use to combat current barriers in primary care. last, to aid in providing unified messages to government officials, systems must be developed to better synthesize medical knowledge among stakeholders. an increase in trained professionals is necessary, and the trained professionals and students at the crossroads of medicine, technology, economics, and diplomacy will be increasingly critical in the evolution of healthcare. the digital age of the st century has played a role in many of the devastating effects of covid- . yet technology has also provided and facilitated new tools, collaboration, and creativity for 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equity. www.racialequityalliance.org © by the author(s) this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license (creativecommons.org/licenses/by/ . /legalcode) that permits unrestricted use, distribution, and reproduction in any medium key: cord- -duxm u v authors: sweileh, waleed m. title: bibliometric analysis of peer-reviewed literature on climate change and human health with an emphasis on infectious diseases date: - - journal: global health doi: . /s - - - sha: doc_id: cord_uid: duxm u v background: assessing research activity is important for planning future protective and adaptive policies. the objective of the current study was to assess research activity on climate change and health with an emphasis on infectious diseases. method: a bibliometric method was applied using sciverse scopus. documents on climate change and human health were called “health-related literature” while documents on climate change and infectious diseases were called “infection-related literature”. the study period was from to . results: the search query found documents in the health-related literature and in the infection-related literature. the growth of publications showed a steep increase after . there were four research themes in the health-related literature: ( ) climate change and infectious diseases; ( ) climate change, public health and food security; ( ) heat waves, mortality, and non-communicable diseases; and ( ) climate change, air pollution, allergy, and respiratory health. the most frequently encountered pathogens/infectious diseases in the infection-related literature were malaria and dengue. documents in infection-related literature had a higher h-index than documents in the health-related literature. the top-cited documents in the health-related literature focused on food security, public health, and infectious diseases while those in infection-related literature focused on water-, vector-, and mosquito-borne diseases. the european region had the highest contribution in health-related literature (n = ; . %) and infection-related literature (n = ; . %). the usa led with ( . %) documents in health-related literature and ( . %) documents in infection-related literature. the australian national university ranked first in the health-related literature while the london school of hygiene & tropical medicine ranked first in the infection-related literature. international research collaboration was inadequate. documents published in the environmental health perspectives journal received the highest citations per document. a total of ( . %) documents in the health-related literature were funded while ( . %) documents in the infection-related literature were funded. conclusion: research on climate change and human health is on the rise with research on infection-related issues making a good share. international research collaboration should be funded and supported. future research needs to focus on the impact of climate change on psychosocial, mental, innovations, policies, and preparedness of health systems. climate change refers to long-term statistical shifts of the earth's climate system that result in new climate patterns [ ] . over the past century, industrial activities have led to long-term changes in the climate system that included global warming, flooding, and drought [ ] . the paris agreement, an agreement within the united nations framework convention on climate change (unfccc) signed in , represents an opportunity for all countries to implement measures to reduce, combat, and adapt to climate change [ ] [ ] [ ] [ ] . combating and reducing climate change is an important goal of the sustainable development goals (sdgs) which states "take urgent action to combat climate change and its impacts" [ ] . the implications of climate change on human health have led the world health organization (who) to declare climate change as one of the top ten global health threats in [ ] . climate change is negatively affecting human lives by changing the quality of air, water, and food supply [ ] [ ] [ ] . it is estimated that between and , climate change will cause approximately , additional deaths per year and - billion usd loss per year by [ ] . these devastating economic and health consequences require national and international planning to slow down climate change and to build resilient health systems that can tackle these changes [ ] . the effects of climate change are global and diverse [ , , ] . however, the impact on developing countries with limited resources and weak health systems will be more obvious [ ] [ ] [ ] [ ] [ ] . climate change has affected the epidemiology and pattern of both communicable and non-communicable diseases [ ] . for example, changes in temperature have serious adverse effects on the pattern and incidence of infectious diseases [ ] . global warming favors the survival and transmission of causative pathogens or vectors of the causative agent [ ] [ ] [ ] [ ] [ ] . climate change influences the dynamics of vector-borne, water-borne, foodborne, rodent-borne, and air-borne infectious diseases [ , ] . furthermore, a recent study predicted that climate change might worsen antimicrobial resistance [ ] . the study indicated that a spike in temperature of c was linked with a . % increase in antibiotic resistance to e.coli, which can trigger serious food poisoning; a . % increase in staphylococcus aureus, which can cause skin infections and food poisoning; and a . % increase in klebsiella pneumoniae, which can cause pneumonia. the spread of antimicrobial resistance is believed to have a serious negative global impact on human health [ ] . a study predicted that if antimicrobial resistance is not addressed, then by , million people will die because of antimicrobial resistance [ ] . many recent studies predicted that serious and emerging infectious diseases could appear or get worsened by climate change [ , ] . it is expected that the epidemiology and geography of many infectious diseases will change due to climate variability [ ] . for example, climate change will be an important factor for the spread of lassa virus in western africa [ ] . droughts are expected to increase the epidemics of west nile virus globally [ ] . higher incidence of cases of chikungunya and zika virus infections in brazil have been attributed to areas with more frequent rainfall and severe droughts [ ] . climate change and increased global temperatures have been associated with an increase in the probability of rift valley fever, cholera and malaria [ ] . the expected rapid spread of infectious diseases with climate change in the presence of antimicrobial resistance might cause global mass fatalities [ ] [ ] [ ] . the who considers climate change as a new threat to global health. this threat is compounded by globalization and modernization which can allow novel diseases to travel rapidly as what happened in the case of covid- [ ] . actually, the emergence of entirely novel diseases, like covid- , reintroduced the discussion of the impact of climate change on infectious diseases carried by wild animals or mosquitos and transmitted to humans. assessing research activity on climate change helps identify the national and international contribution to this field, the hot themes discussed by researchers, and research gaps in the field. climate change is a broad scientific topic and assessing research activity on climate change, in general, might not be very helpful. therefore, in the current study, the research activity of climate change on human health with an emphasis on infectious diseases was investigated. emphasis on infections was made due to suspected serious global outbreaks of infectious diseases such as dengue, ebola, and others [ ] [ ] [ ] [ ] [ ] . second, investigating research activity on climate change will help understand the type of infections mostly affected by climate change. third, research on climate change helps in developing appropriate protective measures and preparedness plans for certain infectious diseases in certain geographical areas. fourth, research on climate change comes as a response to calls made by international organizations such as the who on the importance of the impact of climate change on health and infectious diseases. based on the argument mentioned above and based on calls for papers made by certain specialized and prestigious journals in the field of public health and infectious diseases, the current study was undertaken to analyze the research aspects and research activity of climate change and human health with an emphasis on infectious diseases. the method used to display the research pattern and research activity on a certain topic is the bibliometric analysis which has been commonly used recently in various health topics [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . climate change has diverse effects that include aquatic organisms, forests, animals, and humans. the use of a bibliometric analysis is a suitable methodology to identify the volume and growth pattern of literature focusing on humans for further analysis related to health and infectious diseases. furthermore, bibliometric analysis is a suitable methodology to spot important research themes and active researchers and research institutions for future funding and planning. a literature search using well-known databases and search engines such as scopus database and google scholar revealed that there were at least ten bibliometric studies on climate change and its effects on various aspects on ecology or agriculture or adaptation [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . however, no bibliometric research papers were published on climate change and health or climate change and infectious diseases. therefore, the current study will establish the first baseline data on this topic for future comparisons and for policymakers to draw plans on climate change and human health with an emphasis on infectious diseases. the first step in any bibliometric study is to decide on the appropriate database to be used to retrieve the relevant documents. in the current study, sciverse scopus was used to accomplish the objective of the study. scopus is larger than web of science and has more than , indexed journals in all scientific fields [ ] . scopus is % inclusive of medline and therefore, it is far better than medline. furthermore, the export of data from scopus to other programs is easy to perform. scopus offers two methods of search; a basic and an advanced search in which complex and long search queries can be made to accomplish the objective with high validity. scopus allows for search using terms in titles or titles/abstracts or name of the journal or name of the author or affiliation. the second challenge in any bibliometric study is to build a valid search query that will retrieve as many documents as possible but with minimum irrelevant (false-positive) results. in the field of climate change, many keywords could be used. however, in the current study, the authors reviewed many articles published as "systematic reviews" or "bibliometric analyses" to build a search query for climate change [ , [ ] [ ] [ ] [ ] [ ] . the keywords used included, but not restricted to, the followings "climat* chang*" or "greenhouse effect" or "changing climate" or "global warming" or "extreme weather" or "climate variability" or "greenhouse gas" or "rising temperature" or "heat waves". other non-specific keywords were also used but under certain constraints. for example, keywords such as flood, drought, temperature, warm*, rain*, and "air pollution" were used under the condition that a phrase related to "climat* chang*" was also present in the title/abstract of the same document. the keyword "air pollution/air pollutant*" was used with restrictions because air pollution and climate change are closely related but are not the same. therefore, documents on air pollution within the context of climate change were included [ ] . actually, in systematic review studies on climate change, the keyword air pollution was not included [ , ] . similarly, in previously published blibliometric studies on climate change, air pollution was not included in the search terms [ ] . in scopus, the quotation marks were used to retrieve the exact words while the asterisk was used as a wild card. in the current study, the authors developed an extensive and comprehensive search query to retrieve all potential documents focusing on climate change and human health. the keywords used to retrieve healthrelated documents included, but not restricted to, health, respirat*, mood, cardiac, heart, hunger, "food *security", pregnancy, asthma, infect*, "infectious", "vector-borne disease", "water-borne disease", and many others. the search query was built mainly on title search to make sure that the retrieved documents are obviously and directly related to human health. additional file included all keywords and steps used to retrieve documents on climate change and health. documents retrieved from the search query on human health and climate change were called "health-related literature". for documents related to infectious diseases, the authors used the same search query stated above but with all possible keywords related to infection/infectious diseases, pathogens, and vectors transmitting pathogens to humans. documents retrieved for infectious diseases were called "infection-related document". details on the search query are shown in additional file . validation of the search queries was based on two approaches. in the first approach, the top cited documents in the health-and infection-related literature were reviewed to make sure that they fit within the scope of climate change and health or climate change and infectious diseases. this approach was adopted to eliminate false-positive results by excluding documents focusing on the impact of climate change on certain plants or animals or any document irrelevant to human health. the second approach was based on comparing the actual number of articles for each author, obtained from his/her personal scopus profile, with the number of articles obtained by the search query for active authors. the comparison was made using the pearson correlation test. a significant and strong correlation is indicative of a high validity of the search query and the absence of missing results. this approach was previously used in several bibliometric studies [ ] . data in the retrieved literature was exported to microsoft excel. the exported data included annual growth of publications, types of documents, languages, countries, authors, institutions, journals, citations, and funding agencies. the retrieved literature was also exported to vosviewer program [ ] to create network visualization maps. the strength of international research collaboration was presented as total link strength (tls) which is automatically given by vosviewer upon mapping research activity of selected countries. the tls is proportional to the extent of international research collaboration where higher tls value indicates greater collaboration. bibliometric indicators were presented as top ten active ones. for annual growth, statistical package for social sciences (spss statistics for windows, version . . armonk, ny: ibm corp.) was used to draw the annual growth of publications. for geographical distribution of documents, the who regional classification was used: the region of the americas (amro), the european region (euro), the western pacific region (wpro), the eastern mediterranean region (emro), the south-eastern asia region (searo), and african region (afro). the quality of publications was measured by the number of citations and h-index [ ] while the quality or impact of the journal was measured using the quartile ranking of journals obtained from scimago journal rank [ ] . journals in the q rank are considered to have the highest impact. the study period was from to . all citation analysis and data export were carried out on the same day (april , ) to avoid misinterpretation. the search query found documents on healthrelated literature and documents on infectionrelated literature. therefore, infection-related literature constituted . % of the health-related literature. retrieved documents were of different types (table ). research articles constituted . % (n = ) of the health-related literature and % (n = ) of the infection-related literature. there was a larger percentage of editorials (n = ; . %) in the health-related literature compared with that in the infection-related literature (n = ; . %). the annual growth of publications in the health-related literature was low in the s and s but showed a steep increase after . the annual growth pattern of documents in the infection-related literature followed the same pattern. however, the annual growth of documents in infectionrelated literature was relatively faster than that of the health-related literature. figure shows the growth of publications in the health-and infection-related literature depicted in dual-axis for easy comparison. mapping the most frequent terms in title/abstract fields of documents in the health-related literature with a minimum occurrence of gave terms distributed in four clusters representing four main research themes ( fig. ): . the first cluster (red) included items and focused on the following topics arranged alphabetically: adaptation, climate change, food production, food security, public health, health policy, healthcare system, and psychology. analysis of author keywords in infection-related literature indicated that malaria ( occurrences), dengue ( occurrences), and arboviruses (arthropod-borne viruses) ( occurrences) were the most frequent infectious diseases/pathogens encountered ( (table ). there was a significant and strong correlation between the percentage contribution of each region to health-and infection-related literature (p < . , r = . ). the top ten cited documents in health-related literature focused on the impact of climate change on food security, public health, and infections [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . in the infection-related literature, the top ten cited documents discussed water-, vector-, and mosquito-borne diseases as well as general effects of climate change on infectious diseases, particularly malaria and dengue [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] . the list of top active institutions/organizations for the health-related literature was dominated by australian and american institutions with australian national university ranking first with ( . %) documents ( for the health-related literature, international journal of environmental research and public health was the leading journal with ( . %) documents. in the list of active journals, two journals were in the field of infection while the remaining were in the field of public health, environment, and general medicine ( table ) . table shows the top ten active authors of health-and infection-related literature. researchers from europe, north america, australia, and china dominated both lists. the top active author for the health-related literature was from the usa while the top active author for the infection-related literature was from china. in total, author names participated in publishing the infection-related literature, an average of . authors per cholera salmonella west nile virus plasmodium falciparum influenza tick-borne encephalitis ross river virus zika rift valley fever leishmaniasis japanese encephalitis campylobacter cercariae hantaviruses a this list is not % inclusive of all pathogens or infections present in the retrieved literature. please see result section and fig. for more details document. one hundred and thirty-nine ( . %) documents were single-authored. for health-related literature, a total of ( . %) documents were funded. the national natural science foundation in china was the most active funding agency (n = ; . %) followed by the national institutes of health (nih; usa) and national science foundation (nsf; usa) ( table ) . for the infection-related literature, analysis showed that ( . %) documents were funded. the nih (usa) was the most active in funding (n = ; . %) followed by nsf (usa) (n = ; . %). the who was listed as one of the top ten active funding agencies infection-related literature. the current study was carried out to give a snap shot of research on climate change on human health with an emphasis on infectious diseases. the current study showed an increasing number of publications on climate change and health in the past decade. the gradual increase in the number of publications was parallel to international warning signals since the early s about the impact of climate change on human health. the first major international conference on the greenhouse effect at villach, austria, warned that greenhouse gases will cause a rise of global mean temperature which is greater than any in man's history [ ] . in , the united nations (un) created the intergovernmental panel on climate change (ipcc) to analyze and report on scientific findings. in , climate change convention, agrees to [ ] . in , the kyoto protocol calls for cutting emissions from industrialized nations [ ] . however, due to political and economic reasons in industrialized nations, the koyoto protocol did not come into force until . the ipcc fourth report issued in called for all countries to take adaptive measures to face climate changes [ ] . the steep rise in the number of publications on climate change and human health coincided with the release of the fourth ipcc report which blamed humankind activities for the irreversible climate changes. in the face of increasing evidence of the impact of climate change on human health, the who took an active role in developing policies to minimize the impact of climate change on health. in , the who executive board endorsed a new work plan on climate change and health that included raising awareness, endorse science and research on climate change, and support public health adaptive measures for climate change [ ] . the timeline history, debate, negotiations, and conventions at the international levels affected both the volume and pattern of research on climate change and its impact on human health. the current study indicated that there were four research themes on climate change and human health. these research themes were closely related. of particular interest in the current study was the research theme focusing on climate change and infectious disease. however, there was a small cluster representing the interplay of climate change and air pollution in the context of human health. air pollution is a complex subject and has fundamental effects on human health. in the current study, we focused on air pollution within the context of climate change and the resultant effect on human health. that is why the air pollution research theme was the smallest research theme as shown in the map. both climate change and air pollution are global environmental problems that are closely related and considered as twins but they are not the same thing. climate change is the global variation of the earth's climate which is accelerated by greenhouse gases caused by human activity. carbon dioxide is the main gas contributing to climate change, but it is not harmful to human health. air pollution is defined as the presence, in the air, of substances or particles that imply danger, damage or disturbance for humans, flora or fauna. the main sources of atmospheric contamination are gases that result mainly from emissions caused by the burning of fossil fuels emissions generated by transport, industrial processes, burning of forests, aerosol use, and radiation. both climate change and air pollution are worsened by the burning of fuel, increasing the co emissions which cause global warming. meanwhile, the generation of other pollutants, such as nitrogen oxides (no and no ), sulfur oxides (so and so ) and particulate matter, is the main reason the air is contaminated [ , ] . climate variations affect air quality; air pollution can worsen climate change and both can directly or indirectly affect health [ ] . the major and obvious health effect of climate change and air pollution is on respiratory health where both can exacerbate allergies and bronchial asthma [ ] . the complex interactions between climate change and air quality is a new area of research that requires further investigation [ , ] . the current study indicated that infections constituted a major theme of research on climate change and human health. climate change and temperature rise affect the transmission and spread of many pathogens [ ] . the current study showed that documents about malaria and dengue were among the top ten cited documents. malaria was the most frequently encountered infectious disease affected by climate change. malaria is a vectorborne disease that is sensitive to long-term climate change. for example, malaria epidemic risk increases around five-fold in the year after an el niño event in india [ ] . researchers have developed mathematical models to forecast future climatic influences on infectious diseases. the model aims to apply the statistical equations to future climate scenarios in order to predict the actual distribution of the disease. these models have been applied to malaria and dengue fever [ , , [ ] [ ] [ ] [ ] [ ] [ ] . the case incidence of dengue fever has multiplied fold since the s [ ] . according to the who estimation, . - . % of the world's population ( . - . billion) is living in areas where dengue viruses can be transmitted [ ] . in ranking, two equally active journals were given similar ranks and one position in the rank was skipped. c/d = number of citations per document. q = quartile infection-related literature: documents on climate change and infectious diseases. health-related literature: documents on climate change and health the current study showed that more than two-thirds of the global publications came from the amro and euro regions. there are many reasons for the leading role of these two regions. the presence of the us cdc, euro cdc, and many other governmental and nongovernmental research and academic institutions the field of public health and infectious diseases helped these two regions to make this tremendous and significant contribution. second, the main funding agencies are located in these two regions. third, infections have no borders and pathogens could travel with human migration waves which made europe and north american regions in a critical geographic position to any infectious disease outbreak. fourth, both regions have a great responsibility toward climate change since many of these changes were made by industrial activities. the current study showed that china was among the top ten active countries. the contribution of china might be underestimated because it is possible that most publications from china were published in national chinese journals that are not indexed in scopus. the same argument could be applied to other regions and countries with a limited number of peer-reviewed journals indexed in scopus such as russia or certain countries in south america. the current study showed that afro region made a greater contribution than either emro or searo region. a possible reason for the relatively higher contribution of the afro region is the strong research collaboration between certain african countries and the usa and the uk. climate change in the afro region increased the number of people in africa who are at risk of malaria [ , ] . the increase in the number of mosquitoes increased the opportunity for both plasmodium falciparum and plasmodium vivax parasites to proliferate and place more people at risk of contracting malaria [ , ] . aside from malaria, the afro region is expected to suffer from hunger and food insecurity due to climate change [ , ] . the climate change in the afro region is worsened by the weak economies, lack of resilient health systems, and lack of political stability in certain african regions. the current study showed that the emro region had the least contribution despite that the region is expected to suffer from serious climate variations [ ] . a systematic review on climate change and health in the emro region identified many knowledge and research gaps with research scarcity in this field [ ] . the authors of the systematic review concluded that the impact of climate change on health is not recognized as a priority area by health researchers, health professionals and policymakers in the emro region. international research collaboration and funding are important for countries in the emro, afro, searo regions where effects of climate change are expected to be beyond their economic and research capabilities. the current study showed that retrieved publications received a high number of citations suggestive of a large number of researchers who are interested in the topic. this could be attributed to the following reasons: first, the topic of climate change has caught the attention of scientists all over the world since the early s with many national and international warning reports about the climate change. second, the climate change is a multidisciplinary subject and therefore, researchers and scientists in public health, infectious diseases, nutrition, environmental health, ecology, and others were highly keen to investigate the subject and to have an input in this evolving topic. third, the fact that the top ten active journals in publishing documents were influential in their field gave credibility and attracted a larger number of citations. fourth, the leading role of the who as an international health agency played a positive role in raising the number of citations. finally, the number of authors played a positive role in increasing the number of citations [ ] . the current study indicated that infection-related documents received a higher number of citations and a higher h-index than documents in the health-related literature. this finding suggests that of the diverse health effects of climate change, its impact on the epidemiology and emerging infections receives the greatest scientific attention. this is due to the high and immediate risks of emerging and re-merging infections on global health. the h-index of the infectionrelated literature was higher than that reported for strongyloidiasis literature [ ] , epidermal parasitic skin diseases [ ] , antimalarial drug resistance [ ] , but lower than that on campylobacter or carbapenem resistance [ , ] . the current study emphasizes the importance of certain future research directions in the field of climate change and human health. the current study has a few limitations. the literature investigated has been retrieved from journals indexed in scopus while grey literature and publications in nonindexed journals have not been analyzed. therefore, journals from non-english speaking countries might be underestimated. this has further consequences on the top ten active countries, institutions and authors. the second limitation was the method for counting the number of documents for each country or author or institution. scopus makes all analysis based on the number of different affiliations in the documents. therefore, a document with several authors having the same country affiliation was counted once for that country. however, a document with two authors having two different country affiliations were counted once for each country. this has increased the research output of certain countries with greater international research collaboration even if the authors from that country was not the main or corresponding author. the citation analysis did not take into consideration the self-citations which could create a bias in the number of citations for countries, journals, and authors. finally, the search query was built to focus on climate change and human health. the definition and scope of human health and climate change are broad and complex. therefore, it is difficult to ensure a % inclusion of literature on both topics. however, the author did his best to include all relevant literature with minimum irrelevant documents. the final point is the inclusion of air pollution and air pollutants in the search query. the author included these keywords with restrictions to keep the manuscript focused on climate change. the purpose of including these terms was to retrieve documents discussing air pollution and health within the context of climate change. therefore, the number of documents retrieved in this topic was presented by research theme (cluster ) which was the smallest cluster. inclusion of air pollution in the search query without restriction will retrieve large volume of irrelevant documents on pollution that were irrelevant to climate change. this was the first bibliometric study on climate change and health or infection-related literature. key players, research themes, and research gaps were identified. the current study provided researchers and policymakers with baseline data in this field. the current study emphasized the importance of climate change on the epidemiology and geography of infectious diseases. adaptive national and international measures to combat climate change should include plans to contain the expected increase in vector-borne diseases particularly malaria and dengue. the current study showed inadequate international research collaboration which is highly needed for countries in emro, afro, and searo regions. finally, national and international health organizations should encourage and fund researchers to do continuous assessment and research on the impact of climate 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publications on antimalarial drug resistance bibliometric analysis of global scientific research on carbapenem resistance bibliometric analysis of publications on campylobacter publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the authors would like to thank an-najah national university for giving us the opportunity to access most recent information sources. supplementary information accompanies this paper at https://doi.org/ . /s - - - .additional file . search strategy and keywords for documents on climate change and health (health-related literature). the authors declare that they have no competing interests.received: january accepted: may key: cord- -bi a o authors: benjamin, georges c. title: ensuring health equity during the covid- pandemic: the role of public health infrastructure date: - - journal: rev panam salud publica doi: . /rpsp. . sha: doc_id: cord_uid: bi a o the covid- pandemic has significantly stressed public health systems around the world and exposed the gaps in health care for underserved and vulnerable populations. in the context of the social determinants of health, focusing on health system preparedness is paramount for protecting the health of all of society. faced with old threats (e.g., re-emergence of measles), disruptive new technologies (e.g., electronic cigarettes), increased challenges (e.g. drug-resistant organisms), and new threats (e.g., the current pandemic, climate change, politicized misinformation), our health systems must be robust and resilient. the response must include those who now suffer disproportionately—the poor and the vulnerable. current world health organization priorities call for infrastructures capable of detecting, monitoring, and responding to health emergencies, such as covid- , and the health impacts of climate change in the context of health for all. health care infrastructure can be better prepared and more equitable if systems are strengthened by building on core competencies and following the recommendations made for leadership, stakeholder involvement, accreditation, data collection, and funding resources. ensuring health equity in a pandemic requires robust and resilient public health infrastructure during normal times. on december , officials in the people's republic of china identified four cases of individuals with severe pneumonia linked to a wholesale seafood market. shortly afterward, several other cases were reported, and within weeks an epidemic had engulfed wuhan, the capital city of the hubei province in china. this outbreak of what was a novel coronavirus was the beginning of a worldwide pandemic of sars-cov- , the virus that we now know causes covid- . the pandemic has stressed public health services around the world and has shown the importance of having robust, well-structured, and well-resourced health systems in place. the current pandemic demonstrates the challenges that we must overcome as a global community to ensure equitable health care access, economic security, and public health protections for vulnerable communities. in the united states, the practice environment for public health has changed in many ways, much like that of public health contexts in other nations ( ) . we are in a globalized world, possibly a plane ride away from a major disaster. globalization changes the way we manage health threats-it has closely integrated commerce, transportation, economics, and all forms of communication. the internet and social media have actively democratized information, doing good in many ways when they serve as a major source of factual information. but misinformation and disinformation are also commonplace and create an enormous threat to public health by spreading inaccurate and deceitful material. in addition, the speed at which information now moves around the world is staggering, compounding the difficulties of advancing factual information during a public health emergency. the competition for goods and services has also intensified worldwide and becomes problematic when multiple nations must vie for limited resources in a crisis. given that about % of what makes one healthy occurs outside of the clinical setting, public health systems are working diligently to address the social determinants of health. issues around enhanced social supports, policy changes to encourage healthier choices, improved education, safe transportation, and healthy housing and other improvements to the built environment are some ways public health is addressing the fundamental reasons for health inequities. because of uneven access to resources in underserved and poor communities, social determinants play an over-sized role in undermining health equity. these disparities are especially important when serving people across the lifespan in a changing world. new and disruptive technologies can bring back old threats. for instance, electronic cigarettes are bringing back the dangers of tobacco just when some countries were seeing substantial reductions in tobacco use. also, big tobacco companies in some countries continue incessant marketing and regulatory interference to promote the scourge of tobacco addiction. we have also seen the return of old infectious threats, e.g., measles and tuberculosis; an increase in sexually-transmissible diseases and drug-resistant organisms; and the emergence of new threats, such as ebola, west nile virus, and zika. these remind us that there is still much to be done to ensure a healthy society. we have also had some near successes-polio and chagas' disease, for example. but antivaccine activists who spew disinformation, those who distrust government, and ongoing armed conflicts continue to inhibit our ability to stamp-out many preventable diseases. in many countries, public health has become a political football, with politicians undermining sound public health policies to the detriment of the population. too often, scientific principles are being questioned by politicians and policy-makers solely for political gain and ideological reasons. we live in a dangerous world, with many health threats, among which climate change is paramount. our changing climate continues its dramatic impact on the planet's ecology and produces major threats to public health. the world health organization (who) has identified the health impacts of climate and environmental change as a priority area, reporting that over . million people die annually from unhealthy environmental conditions ( ) . furthermore, the underserved are extremely climate sensitive and suffer disproportionately from climate change. another who priority is public health preparedness for health emergencies ( ) . this priority addresses the scope of emergencies around the world that impact public health, from famine and armed conflicts to environmental disasters and infectious pandemics. the covid- pandemic is one such global health emergency. a robust public health system, one capable of detecting any new health threat and monitoring and responding to it, is an essential component of a resilient health system. in , the institute of medicine of the national academies of sciences, engineering, and medicine authored a consensus report titled the future of public health ( ) . it defined three core competencies of public health -assessment, policy development, and assurance-and core competencies of effective health departments ( figure ). these competencies are currently being reviewed by the public health accreditation board (phab) of the united states, the country's accrediting body for state and local governmental public health agencies. recently, the phab began to consider offering accreditation to non-u.s. agencies. a concept called public health . ( ) was released in by a working group under the auspices of the united states department of health and human services, the federal agency that serves as the country's ministry of health. public health . lays out five recommendations for public health agencies that seek to meet the challenges of the st century ( ). these are relevant for agencies in other country's health systems as well: strategist for all communities. this is a leadership role that works with all stakeholders to address the social determinants of health. it may be assumed by stakeholders in other sectors when appropriate, however all members of the leadership team should develop the competencies to support this system-wide leadership role. effects, and creating economic hardship as physical distancing forces the shutdown of many nations' economies for months at a time. tragically, underserved and vulnerable populations are being disproportionately affected, just as they are by most health threats. it is essential that we focus efforts on ensuring that vulnerable populations receive equal access to testing, community protections, and treatment when they get sick. in addition, economic burdens for this population can be overwhelming as many live from paycheck to paycheck during normal times and are dependent on a range of social supports for survival. during extraordinary times such as this, extraordinary levels of support are needed to alleviate food insecurity, strengthen health care systems, and protect human rights, especially the rights of women and children, who frequently experience domestic violence and social practices that harm them disproportionately. economic support is also essential because severe economic disruptions affect low-income workers the most. nations with weak health systems are at significant risk from this pandemic and will require significant support from other nations to prevent widespread morbidity and mortality. strengthening public health systems should be a global priority for addressing health equity. the covid- pandemic is imposing enormous strain on public health systems and is a tragic example of the need for strong systems to promote and protect health and ensure health equity. a well-resourced and properly-structured public health system that is accountable, properly resourced, and able to perform the core competencies can meet the needs of vulnerable populations and ensure equity is achieved across the lifespan in all communities. disclaimer. authors hold sole responsibility for the views expressed in the manuscript, which may not necessarily reflect the opinion or policy of the rpsp/pajph and/or paho. should ensure they have the leadership and collaborative skills to engage all relevant stakeholders across multiple private and public sectors. these collaborations should have shared governance that works to obtain adequate resources and collective action to achieve shared health promotion and disease prevention objectives. actions should produce equitable and resilient communities. . public health accreditation. public health agencies should seek accountability for their public health responsibilities. in the united states, this can be done by becoming phab accredited. accreditation has been shown to improve agency capacity and quality ( ) . the recommendations of public health . are embedded in the appropriate phab criteria. currently, about % of the united states population is covered by an accredited health department (https://phaboard.org/ / / / benefits-of-phab-accreditation-reaching-more-communitiesas-covered-population-continues-to-climb/) and the goal is to achieve %. . improving data for decision making. public health agencies must have access to more secure, granular data (preferably at the sub-county or postal-code level) in a timely way to make actionable health decisions. today, health threats enter communities with great speed and the need to address them requires cross-sectoral data systems that allow for the ability to measure impact in a variety of ways. data systems must collect data in a way that allows health equity to be evaluated. . adequate public health funding. funding for public health has been inadequate, not only in the united states, but also in many industrialized nations, and especially those with weak health systems ( ). public health . supports enhancing resources for public health systems to ensure adequacy and sustainability. development of new and innovative models to achieve this enhanced support are recommended, both for core activities and community-wide initiatives. funding is essential for achieving health equity objectives. covid- , the pandemic that the world has feared, is here. it is ravishing the health of communities through its direct asegurar la equidad en la salud durante la pandemia de covid- : el papel de la infraestructura de salud pública resumen la pandemia de covid- ha sometido a una gran exigencia a los sistemas de salud pública de todo el mundo y ha puesto de manifiesto las deficiencias de la atención de la salud de las poblaciones desatendidas y vulnerables. en el contexto de los determinantes sociales de la salud, es fundamental centrarse en la preparación del sistema de salud para proteger la salud de toda la sociedad. frente a las viejas amenazas (p. ej., la reaparición del sarampión), las nuevas tecnologías perturbadoras (p. ej., los cigarrillos electrónicos), los mayores desafíos (p. ej., los microorganismos resistentes a los medicamentos) y las nuevas amenazas -la pandemia actual, el cambio climático, la politización de la información y la desinformación sobre la saludnuestros sistemas de salud deben ser sólidos y resilientes. su respuesta debe incluir a quienes ahora sufren de manera desproporcionada, los pobres y los vulnerables. las prioridades actuales de la organización mundial de la salud requieren infraestructuras capaces de detectar, vigilar y responder a las emergencias sanitarias, como la covid- , y a los efectos del cambio climático sobre la salud en el contexto de la salud para todos. si se fortalecen los sistemas de salud reforzando sus competencias básicas y siguiendo las recomendaciones formuladas en materia de liderazgo, participación de los interesados, acreditación, recolección de datos y recursos de financiación la infraestructura de atención de la salud estará mejor preparada y será más equitativa. para garantizar la equidad en la salud en una pandemia se requiere una infraestructura de salud pública sólida y resiliente en épocas normales. políticas, planificación y administración en salud; control de enfermedades transmisibles; poblaciones vulnerables; equidad en salud. equidade em saúde durante a pandemia da covid- : o papel da infraestrutura pública de saúde resumo em todo o mundo, a pandemia da covid- tem colocado ênfase significativa nos sistemas públicos de saúde e exposto as lacunas nos cuidados em saúde para populações carentes e vulneráveis. no contexto dos determinantes sociais da saúde, o foco na prontidão dos sistemas de saúde é fundamental para a proteção de toda a sociedade. diante de antigas ameaças (por exemplo, o ressurgimento do sarampo), novas tecnologias disruptivas (por exemplo, cigarros eletrônicos), maiores desafios (por exemplo, organismos resistentes a drogas) e novas ameaças -a atual pandemia, as mudanças climáticas, a politização da informação/informação sobre saúde -os sistemas de saúde devem ser robustos e resilientes. a resposta desses sistemas deve incluir grupos que agora sofrem de forma desproporcional, os pobres e os vulneráveis. as prioridades atuais da organização mundial da saúde exigem infraestruturas capazes de detectar, monitorar e responder a emergências de saúde como a covid- e aos impactos das mudanças climáticas sobre a saúde no contexto da saúde para todos. a infraestrutura de saúde estará mais bem preparada e será mais equitativa se os sistemas forem fortalecidos com base em competências essenciais e seguirem recomendações com foco em liderança, envolvimento das partes interessadas, acreditação, coleta de dados e recursos de financiamento. garantir a equidade na saúde em uma pandemia requer uma infraestrutura pública de saúde robusta e resiliente, mesmo em tempos normais. palavras-chave políticas, planejamento e administração em saúde; populações vulneráveis; controle de doenças transmissíveis; equidade em saúde. committee on investing in health systems in low-and middle-income countries; board on global health investing in global health systems: sustaining gains, transforming lives institute of medicine (us) committee for the study of the future of public health. the future of public health public health . : a call to action for public health to meet the challenges of the st century evaluating the impact of national public health department accreditation key: cord- -rj te fz authors: stone, teresa e.; kunaviktikul, wipada; omura, mieko; petrini, marcia title: editorial: facemasks and the covid pandemic: what advice should health professionals be giving the general public about the wearing of facemasks? date: - - journal: nurs health sci doi: . /nhs. sha: doc_id: cord_uid: rj te fz nan and a lack of personal protective gear. hospitals resorted to pleading on social media for more protective equipment (gan, thomas, & culver, ) . medical staff during the height of the crisis in wuhan, had only one protective suit per day and were forced to wear diapers as they could not change their protective gear for as long as hours. the numbers of health professionals falling ill have obviously led to further shortages and one wuhan doctor was quoted as saying, "just a very rough estimate, nurses and doctors can look after ordinary beds and icu beds. if they are sick, not only do they occupy beds, but the staff taking care of beds are gone. that means a hospital loses the capacity of beds." (ma et al., ) . in the light of this, china's national health commission's warning to health professionals to make "reasonable use" of protection gear warning against "excessive and disorderly use" (frias, ) seems unreasonably harsh. the same issues are being seen across the globe as the pandemic spreads: over italian health workers contracted the disease and there have been many deaths partly as a result of a lack of availablity of personal protective equipment (international council of nurses, ) . it is a similar story in spain with over health workers infected as of the end of march nearly % of the total infections in that country (minder & peltier, ) . panic buying of masks has resulted in shortages across the world. over , people queued up for masks in hong kong, with one woman waiting for over hours, and another reported that she had used the same mask for over five days (huang & tong, ) . a shipment to hong kong was deemed so valuable it had an armed escort (woodhouse, kuchler, & liu, ) . the world health organization's director general, dr. tedros adhanom ghebreyesus, said that, as a result of the covid- outbreak, demand for personal protective equipment was times higher than average, and prices had risen to times higher resulting in global stocks of masks and respirators being insufficient to meet supply (boseley, ) . he went on to say that there were delays of four to six months in supply and that the shortage was due to "widespread inappropriate use" by those who were not ill or not medical staff. one consequence is that the second-worst hit city in hubei province faces a shortfall of , of protective gear, , masks, as well as , this article is protected by copyright. all rights reserved. accepted article goggles and face shields (frias, ) and there are people in the streets wearing the n mask and other professional masks that healthcare workers need. videos have emerged from wuhan, the epicenter of covid- , of the chinese government using drones to admonish people for not wearing masks (pietsch, ) and villagers have taken to the same tactics: this clip shows a woman being scolded by a man operating a drone in an inner mongolian village https://www.youtube.com/watch?v=--nn k rc u. ironically the wearing of masks has hindered efforts to trace suspected carriers because the surveillance technology cannot recognize faces (chen, ) . despite the advice from the world health organization (who) ( ) that frequent handwashing with soap and water or use of an alcohol-based hand rub is the primary means of prevention along with respiratory hygiene, maintaining social distance and avoiding touching the eyes, nose and mouth many organizations outside of health are advising mask use. for example, across japan, hotels, transport, and retail staff wear masks and frequently, this is a company directive. for instance, all nippon airways (ana), japan airlines (jal) and japan railways (jr) have explained that staff wears masks "to provide safe services for customers," among other reasons. in some other cases the request to wear masks has come from employees, for example, the association of flight attendants-cwa, which represents flight attendants from hawaiian and more than a dozen other airlines, is asking airline to allow flight attendants to wear masks on flights to and from asia (oliver & thompson, ) . to date, there has been mounting anger as the airlines have refused this request citing the centers for disease control and prevention ( ) policy that that face masks should only be used by airline crew members when they "are helping sick travelers with respiratory symptoms such as coughing or sneezing." facemasks are also advised for sick travelers and those sitting near passengers with respiratory conditions. more concerningly, some health professionals and government organizations have misconceptions about mask efficacy: for example, the thai health minister is strongly this article is protected by copyright. all rights reserved. accepted article advocating the use of face masks contrary to who advice and health officials in many asian countries have required the general public to wear masks (boonbandit, ; tufekci, ) . so, is wearing a mask likely to be preventive? experts tell us that it is less useful than frequently washing hands. the world health organization's director general recently pointed out that masks were not always beneficial for the healthy general public, "masks don't necessarily protect you, but they doif you have the diseasestop you from giving it to anybody else" (boseley, ) . authors of a recent systematic review of ten randomized control trials found limited evidence for face mask effectiveness in preventing influenza virus transmission either when worn by the infected person to avoid transmission or when worn by uninfected people to reduce exposure (xiao et al., ) summing up evidence pawlowski ( ) notes that surgical masks are designed for surgeons to wear to prevent the transmission of pathogens from their nose and mouth to the surgical field; they are not intended to avoid viruses being inhaled through the mask. neither are they designed to be worn for extended periods as many of the general public do. the shortage of masks has led to a range of inappropriate and potentially dangerous ways of covering the nose and mouth. children and adults in china have used plastic bags to cover themselves and resorted to other desperate measures such as wearing plastic bottles over their heads, ski masks and even sanitary towels. more frequently seen are cloth masks or scarves used as a mask, and there is no compelling evidence to suggest that these are effective. knowledge about the sars-cov- virus is rapidly evolving, but it is thought that the virus is transmitted through droplets, direct contact, and by coming into contact with contaminated surfaces and it is not known to be airborne and cannot circulate through the air (united nations, ). the respiratory droplets may travel up to six feet from someone who is sneezing or coughing. bai ( ) cites chiu an infectious disease expert who states that "if you have an infected person in the front of the plane, for instance, and you're in the back of the plane, your risk is close to zero simply because the area of exposure is thought to be roughly six feet from the infected person." authors of a recent systematic review concluded that most viruses from the respiratory tract, such as corona, influenza, or sars can persist on surfaces for a few days and can thereby be a continuous source of transmission if no regular preventive surface disinfection is performed (kramer, schwebke, & kampf, ) . the sars-cov- virus resembles other human coronaviruses, such as those that cause sars and mers and can stay on surfacessuch as metal, glass or plastic this article is protected by copyright. all rights reserved. accepted article for as long as nine days but can be efficiently inactivated by surface disinfection procedures with - % ethanol, . % hydrogen peroxide or . % sodium hypochlorite within minute (kampf, todt, pfaender, & steinmann, ) . the extensive media reporting and frequent use of pictures of people wearing masks may have had a role in fueling the mask-wearing frenzy, but there have been many articles with sensible, evidence-based advice cautioning against a reliance on masks and instead washing hands frequently in soapy water, using correct etiquette when coughing and sneezing and avoiding touching the face and referencing reliable sources for the information they give (boseley, ; secon, ) . the director general of the centers for disease (cdc) control said: "i think this virus is probably with us beyond this season, beyond this year, and i think the virus eventually will find a foothold and we'll get community-based transmission and you can start to think about it like seasonal flu. the only difference is we don't understand this virus" (moreno, ) . we need to respond appropriately to the threat from this threat knowing that climate change, global interconnectedness, antivaccine sentiment and a myriad of other factors leave us vulnerable to global pandemics and increasing infectious disease outbreaks (global preparedness monitoring, ). along with unknown viruses, we also need to manage the ones we know. in the - season, there have been at least million cases of influenza and , deaths including children in the united states alone (guzman, ) . as health professionals, we need to be clear about what preventative measures we should take and about the advice we give the public. the primary advice for prevention is effective handwashing with soap and water for at least seconds, rubbing the hands together and avoid touching the mouth, nose and eyes (world health organization, ). the inappropriate use of masks has become a moral issue leaving frontline health workers without the necessary protective equipment. as health professionals, we have an obligation to model appropriate health behaviors and disseminate accurate health information based on current evidence that the use of surgical facemasks by the general public is not recommended unless they are looking after a sick person in a household setting or are themselves suffering an illness. far more effective is through handwashing and maintaining a safe distance from other people. how-to-use-masks how to choose and wear a mask safely how the new coronavirus spreads and progresses -and why one test may not be enough anutin: farangs who don't wear masks 'should be kicked out who warns of global shortage of face masks and protective suits coronavirus outbreak tests china's surveillance technology thousands of chinese doctors volunteered for the frontline of the coronavirus outbreak. they are overwhelmed, under-equipped, exhausted, and even dying over , frontline medics infected with coronavirus in china a world at risk: annual report on global preparedness for health emergencies coronavirus is spreading -but the flu is a greater threat to americans coronavirus outbreak: hong kong mask shortage reveals failings of a free market high proportion of healthcare workers with covid- in italy is a stark warning to the world: protecting nurses and their colleagues must be the number one priority persistence of coronaviruses on inanimate surfaces and its inactivation with biocidal agents how long do nosocomial pathogens persist on inanimate surfaces? a systematic review hundreds of chinese medical staff infected with coronavirus face mask use and control of respiratory virus transmission in households virus knocks thousands of health workers out of action in europe cdc director says coronavirus could stay in us through this year and beyond flight attendants ask hawaiian airlines to permit expanded mask usage amid coronavirus concerns coronavirus outbreak leads stores to sell out of face masks china is using drones to scold people for going outside and not wearing masks amid the coronavirus outbreak people are racing to buy face masks amid the coronavirus outbreak, but they probably won't protect you from illness preventing spread of disease on commercial aircraft: guidance for cabin crew why telling people they don't need masks backfired coronavirus: un health agency moves fast to tackle 'infodemic'; guterres warns against stigmatization masks and n respirators clinical characteristics of hospitalized patients with novel coronavirus-infected pneumonia in exploring the reasons for healthcare workers infected with novel coronavirus disease (covid- ) in china mask mania: coronavirus sparks global scramble for face covers advice on the use of masks in the community setting in influenza a (h n ) outbreaks basic protective measures against the new coronavirus nonpharmaceutical measures for pandemic influenza in nonhealthcare settings-international travel-related measures key: cord- -w catjj authors: degeling, chris; johnson, jane; kerridge, ian; wilson, andrew; ward, michael; stewart, cameron; gilbert, gwendolyn title: implementing a one health approach to emerging infectious disease: reflections on the socio-political, ethical and legal dimensions date: - - journal: bmc public health doi: . /s - - - sha: doc_id: cord_uid: w catjj background: ‘one health’ represents a call for health researchers and practitioners at the human, animal and environmental interfaces to work together to mitigate the risks of emerging and re-emerging infectious diseases (eids). a one health approach emphasizing inter-disciplinary co-operation is increasingly seen as necessary for effective eid control and prevention. there are, however, socio-political, ethical and legal challenges, which must be met by such a one health approach. discussion: based on the philosophical review and critical analysis of scholarship around the theory and practice of one health it is clear that eid events are not simply about pathogens jumping species barriers; they are comprised of complex and contingent sets of relations that involve socioeconomic and socio-political drivers and consequences with the latter extending beyond the impact of the disease. therefore, the effectiveness of policies based on one health depends on their implementation and alignment with or modification of public values. summary: despite its strong motivating rationale, implementing a one health approach in an integrated and considered manner can be challenging, especially in the face of a perceived crisis. the effective control and prevention of eids therefore requires: (i) social science research to improve understanding of how eid threats and responses play out; (ii) the development of an analytic framework that catalogues case experiences with eids, reflects their dynamic nature and promotes inter-sectoral collaboration and knowledge synthesis; (iii) genuine public engagement processes that promote transparency, education and capture people’s preferences; (iv) a set of practical principles and values that integrate ethics into decision-making procedures, against which policies and public health responses can be assessed; (v) integration of the analytic framework and the statement of principles and values outlined above; and (vi) a focus on genuine reform rather than rhetoric. the recent ebolavirus (ebov) outbreak in west africa and continuing human infections with a novel h n influenza a virus in mainland china are salient reminders of how human and nonhuman health are inextricably linked. nonhuman animals are the source of % of emerging and re-emerging infectious disease (eid) threats to human health [ ] , and more than half of all established human pathogens [ ] . the threats posed by eids are dynamic. eids are caused by pathogens that can change their behaviour over timeeither through genetic modification or through changes in the patterns and pathways of transmission [ ] . social, economic and political systems can either promote or inhibit pathogen transfer, and the incidence and pathogenicity of the disease [ ] . while a lack of data makes quantitation difficult, eids and zoonoses account for a significant proportion of the global disease burden [ ] . eids and emergence of zoonotic pathogens, including human immunodeficiency virus (hiv), are direct causes of an estimated million deaths worldwide each year [ ] . a one health approach is increasingly considered to be the most effective way of managing eid threats [ , ] because it represents an acknowledgement of certain facts about the nature of disease, which are then deployed to structure the response. one health is grounded in a recognition that human, animal and environmental health are interdependent [ ] , that animal species provide a shared reservoir for pathogen exchange and spread, and that many eids are driven by varied and dynamic human-animal interactions [ , ] . the response one health offers is to deconstruct the disciplinary silos [ ] which have separated biomedical and social sciences devoted to the study of human disease from those devoted to nonhuman disease and ecological concerns [ , ] . inter-disciplinary research is called for and required, as is interventionist practice at local, national and international levels involving: policymakers, planners, regulators, physicians, veterinarians, ecologists, public and animal health officials, environmental health officers, microbiologists, and other allied natural and social scientists [ , ] . although principally associated with eid prevention and control, one health is also relevant to prevention and control of endemic and zoonotic animal diseases, as well as securing food safety [ , ] . considering the magnitude and complexity of global issues surrounding infectious disease and food security, the one health approach has the potential to provide the creative, effective and sustainable solutions required. despite its strong motivating rationale, implementing a one health approach can be challenging. dealing with eids in an integrated and considered manner can be highly problematic, especially in the face of a perceived crisis. in this paper we examine the socio-political, ethical and legal considerations implied by a one health approach to eids. first we describe how a one health approach could galvanise and enhance current capacity in eid prevention and control. making reference to case examples, we then identify and characterise sociopolitical, ethical and legal concerns that have the potential to limit the effectiveness of one health interventions. finally, we draw on this data to provide guidance as to how these concerns and issues might be addressed, and point to remaining challenges to the likely success of the one health approach to eid control and prevention. in order to explore the broader implications of a one health approach we employed philosophical and qualitative methods to map existing and potential scientific, ethical and political responses to eids in australia and our region. the overarching philosophical approach is that of developing sustained arguments that critically analyse the existing literature and reconceptualise or refine key concepts. this conceptual information is often observed in exemplars and paradigm cases. in particular we focused on materials pertaining to the social, political and ethical consequences of responses to the risks posed to human health and wellbeing by hendra virus [hev], nipah virus [niv] and rabies virus [rbv] in australasia, and compared them with international responses to canonical examples of pandemic and food borne zoonoses severe acute respiratory syndrome (sars) [ ] and bovine spongiform encephalitis/variant creutzfeldt jacob disease (bse/vcjd), respectively. a synopsis of the characteristics and burdens of these diseases and the pathogens that cause them are outlined in boxes and . because our aim was to generate inductive insights and develop a robust set of argumentsrather than a comprehensive catalogue of every case example or publicationthe sample evolved iteratively from searches of textual sources such as publicly available international (e.g. who) and government reports; academic databases (e.g. pubmed); online/print news services (factiva); organizational newsfeeds (centers for disease control); and the websites of major one health collaborations [ ] . materials in the sample were read and qualitatively reviewed through an iterative process of testing, revising and refining our definitions, principles and theoretical generalisations [ , ] against the emerging conceptual map and feedback from the research team. led by the first author, this cycle of searching, mapping and critical analysis continued until a period where new textual materials were not providing substantive new insights and the team was confident that a position of conceptual saturation had been achieved. in what follows we draw on these analyses and reflections to describe the content, context and nature of the challenges that need to be faced for the effective implementation of a one health approach to eid control and prevention. findings eid prevention and control strategies require a one health approach one health is a holistic approach that emphasizes, but is not restricted to, the need to understand and regulate the environmental context (human-animalecosystem interface) of disease emergence and expression [ ] . eids are characterized by their complexity and uncertainty as to their causes, consequences and likely solutions [ ] . in broad terms, the occurrence and cross-species transmissibility of many emerging pathogens, like ebolavirus (ebov) and h n , arise from human activities such as changes in land use, growth in global trade and travel and intensification of animal husbandry practices [ ] [ ] [ ] . the speed with which our understanding of the biology and epidemiology of h n has developed demonstrates how much our ability to respond to new eid threats has improved over the last few decades. yet despite advances in immunobiology and genomics that have contributed to diagnostics, therapeutics, and vaccine development, the threat of eids to human health and community wellbeing persists. part of the reason why eid threats remain in spite of scientific advances, are that eid events are not simply about pathogens jumping species barriers. the threats posed by eids are comprised of complex and contingent sets of relations that involve socioeconomic and sociopolitical drivers and consequences, with the latter extending beyond the impact of the disease. the social, cultural and economic impacts of zoonoses are significant. the examples contained in tables and demonstrate the difficult balance between the human health risks and socioeconomic and cultural costs of eid control [ , ] . policy decisions should be based on sound evidencebut it is often the case in dealing with eids that the evidence required is absent or fluid. eid events are often dynamic situations that are characterised by uncertainty. as events unfold new evidence is created. consequently decisions made on the basis of present data can be seen as wrong in the future, as more evidence and a better understanding emerges. official reviews of canonical eid events such sars [ ] and bse/vcjd [ ] share two key findings: (i) that actions to reduce risk should not be predicated on scientific certainty; and (ii) that policies to deal with the risks and effects of an eid need to be founded on widely held values, so that people understand, in advance, the kinds of choices that will have to be made. this suggests that the one health approach needs more than inter-sectoral collaboration and robust health legislation, as the unique nature of eids critically limits the effectiveness of scientific, top-down and technocratic approaches to governance [ ] . hendra virus infection is endemic among at least two species of flying fox in australia and causes rare, but catastrophic, human infection [ ] . loss of habitat has led to increasingly intense incursions of flying foxes into populated rural and peri-urban areas and promoted the 'spill-over' of hendra virus into horses and then to people [ ] . hundreds of people have been directly exposed to hendra virus, with seven confirmed human infections and four deaths since . with over one hundred dead horses and persistent risk, the emergence of hendra has had significant impact on equine and tourist industries in north eastern australia, diverted major research resources and caused significant distress and controversy in the broader community [ , ] . nipah virus, a close relative of hendra, is endemic in east asian flying fox populations. in , after a program of deforestation and agricultural development in eastern malaysia it spread to pigs then humans and other animals, causing respiratory disease and severe encephalitis [ ] . it subsequently was reported in india and bangladesh. humans can be infected directly from bats, by ingestion of contaminated food and from other humans. among confirmed human cases, the overall mortality was greater than % [ ] . nipah control programs devastated malaysia's pig industry and caused high unemployment and dislocation of rural populations, at a cost of more than us$ billion to the national economy [ ] . nipah virus has been identified by who as a likely cause of future pandemics. rabies virus infects the central nervous systems of people, wildlife and domestic mammals. the disease is transmitted by bites from infected animals and once it becomes symptomatic, it is virtually always fatal. , people die and . million receive post exposure prophylaxis annually, costing $ billion [ ] . rabies is endemic in much of south east asia but its range is expanding. focusing on australia, the continent is free from rabies, but the current expansion of the disease in indonesia [ ] is a genuine threat to northern regions. although likely controllable in domestic dog populations [ ] , if rabies were to become endemic amongst wild or feral animals in this setting, current modelling indicates it would be almost impossible to eradicate [ ] . table significant historical (i.e. effectively eradicated) eids severe acute respiratory syndrome (sars) is a human respiratory infection, caused by a coronavirus isolated from chinese horseshoe bats [ ] . it was first reported in asia in and, within a few months, spread to thirty seven countries in the americas, europe and asia. it affected more than people and caused deaths, before being successfully eliminated by concerted international efforts. the outbreak and fear that another pandemic could occur are estimated to have cost canadian and east asian economies us$ billion [ ] . bovine spongiform encephalitis/variant creutzfeldt jacob disease (bse/ vcjd) is a rare but fatal human neurodegenerative condition, caused by consumption of bovine products contaminated with the prions that cause bse. since vcjd was first identified in , cases have been reported in the uk and forty nine elsewhere. the world bank estimates that the direct costs of vcjd/bse to date exceed more than us $ billion. infected herds and the control measure imposed to prevent further infections devastated agricultural communities. the impacts of the emergence of a new zoonotic disease amongst the british public were far broader than agriculture, including the cessation of uk plasma production because of potential iatrogenic infection. with an estimated one in uk residents carrying vcjd, the burdens will continue well into this century [ ] . the success of one health depends on more than scientific knowledge and technical achievement because some of the issues that arise in addressing eid risks are socalled 'wicked problems' [ ] . when a new eid threat emerges there are rarely ready-made solutions and health policymakers and practitioners are often forced to make tragic choices that may contravene widely held values. considerations must include the need to protect public health and the wider social, economic and environmental impacts of proposed interventions. economic and political interests can complicate the decisionmakers' motives and decision-maker uncertainty is compounded by policy decisions becoming entangled in political, ethical and legal considerations [ ] [ ] [ ] . as events surrounding the ebov outbreak in west africa illustrate, the importance placed on a specific eid threat at any one time also depends on who is setting the agenda [ ] . therefore to be successfully implemented, the one health approach must address a range of socio-political, ethical and legal challenges that arise as a consequence of the spread of infection within and between species. most of these challenges are not unique to one health, but are shared by any approach to addressing eids. however these challenges frequently go unrecognized. in the following section we will clarify the nature of these issues so they can be addressed later in the paper. ( )socio-political challenges a focus on individualism, perceptions, short term solutions, populism and avoiding controversy are features of political life, which can prove challenging for eid policy and work against developing effective strategies for addressing eids. policy responses to eid events such as nipah and hendra virus infections (outlined in box ) tend to focus on necessary and proximal causes (what individuals do to put themselves at direct risk from an infectious pathogen) because the science about other aspects of eids is often complex, uncertain and lacking a clear narrative. compounding this, our moral psychologies have evolved to respond to direct harmsnot indirect distal causal stories. many people in liberal democracies believe that they are entitled to rights and freedoms that cannot be sacrificed merely for the marginal gains of others. as the discourse surrounding climate change and other wicked problems illustrates, this promotes technological solutions because they do not require substantive changes in human behaviours and underlying values systems. [ ] the net result is that the policy focus for eid prevention and control tends to remain on individual behaviours rather than the structural drivers of emergence and transmissiona case example being the focus on vaccine development and the husbandry practices of horse owners in response to the zoonotic risks of hendra virus [ , ] .. the political impetus for action in response to many eids is not necessarily scientific evidence but societal perceptions. indeed, in the face of scientific uncertainty and ethical ambiguity, ideological perspectives and short-term political considerations often supplant efforts to devise effective long-term interventions [ , ] . political imperatives to avoid, or at least minimise, public concern whilst dealing with eids can also prove challenging. in the case of bse, powerful interests dominated early government responses, leading policymakers to make decisions that avoided public controversy, but had major economic consequences. as the crisis unfolded, expertise became politicized leading to conflict between agencies and policy inconsistency between health communication strategies and the measures being taken to minimize the risks to human health [ ] . even when the link between bse and vcjd became clear, existing feed bans were poorly enforced and risk communication was dominated by fear of public panic [ ] ; even as the decision was made to remove all potential sources of human infection from the uk food supply, messages were confused and policy implementation impeded by poor co-ordination between agencies [ ] . a common but problematic response to eid threats has been to invoke the precautionary principle. roughly speaking, the precautionary principle can be applied in situations where human activities create a scientifically plausible, but uncertain, risk of significant harm. in response the principle advocates that actions ought to be taken to avoid or reduce the harm, and that these actions need to be proportionate to the seriousness of the potential harm. in other word, in the absence of evidence take a conservative approach. however applying the precautionary principle to eids in an attempt to protect the public can result in what, in retrospect, amounts to an excessive response. this occurred with attempts to control nipah infection, where significant damage was inflicted on industry, livelihoods and the economy. similarly, experience with highly pathogenic avian influenza (hpai) h n in china and se-asia showed that overzealous policy responses can destroy livelihoods and threaten food supplies [ , ] . in vietnam alone, almost million birds were culled in in an attempt to eradicate hpai. although many birds were owned by large commercial operations, others were kept by 'backyard' farmers and villagers. mass culling of poultry appears decisive, but places excessive burdens on vulnerable populations, is ineffective in the context of extensive 'backyard' poultry farming and can, in fact, promote the spread of disease [ ] . a similar scenario is currently playing out with rabies control in bali. unfortunately, the precautionary principle and analytic tools and concepts appealed to in this domain, fail to deliver what is required at times of eid outbreaks since they do not advance public engagement or help resolve disagreements in times of uncertainty [ , ] . philosophical critiques of the precautionary principle applied to eids have also shown its limitations, including that defining criteria by which to judge a threat as plausible and a response proportionate, often will only substitute one uncertainty for two others [ ] . ( )ethical challenges the effectiveness of an eid control policy will depend on the context of its implementation and particularly its alignment with stakeholder and public values [ , ] . in modern liberal democracies at least some consensus over what is in the public interest and an understanding of the values which support it, is therefore required for the successful implementation of eid responses. yet this is precisely what has been lacking in outbreaks where fracture lines, differences and value conflicts have become apparent. when the stakes are high, evidence and the implications of actions are uncertain, the situation is complex and resources may be limited but where decisions need to be made, differences are exposed. such differences could be around beliefs about how to deal with ecological and environmental issues, which may conflict with the importance people attach to public goods, protection of individual autonomy and animal welfare [ ]. these conditions of crisis and division are conducive to undesirable consequences including public fear, mistrust, misinformation and non-compliance with public health directives. for example in canada during the sars crisis, leaders were unprepared for the range of ethical conflicts that arose, including those over: individual freedom versus the common good; healthcare workers' safety versus their duty to care for the sick; and economic costs versus the need for containment [ ] . as indicated in box , both the outbreak itself and fear that another outbreak could occur had significant economic consequences. any approach which hopes to successfully respond to eid threats, including a one health approach, needs to address the ethical concerns articulated above. to this end, potentially conflicting values and logic must be negotiated to realise effective, sustainable and just solutions. prioritisation and resource allocation require political processes based on fundamental ethical questions about what is valuable, what is to be protected and, ultimately, what is dispensable. to be effective, public policy must be consistent with the values of citizens to whom it is applied, otherwise it can become mired in controversy about whose values should prevail [ , , ] . therefore, one of the first and most important tasks of policy work is to establish how the public interest is best defined. ( )legal challenges the legal environment in which eid policy is made and in which responses to outbreaks occur, presents its own set of challenges. the law surrounding eid responses in most jurisdictions is diffuse, complicated and often subject to re-interpretation on the basis of whose interests are given primacy at the time decisions are made. moreover, in many countries different approaches by state/provincial and local authorities, overlaid by federal/national powers, complicate regulation so much that 'hard law' is often replaced by resort to 'soft law' of executive and administrative powers and international instruments, such as the international health regulations (ihr) [ ] . this may add complexity and confusion to the eid regulatory structures, rather than facilitating public health responses to a new threat. such confusion provides a salient reminder that even in 'global law' approaches to eids, the sovereign state remains the institution responsible for regulation and control [ ] . public health law responses to eids tend to be oriented towards controlling cross-border pathogen transfer and community outbreaks rather than the underlying deficiencies and structural conditions from which the threats emerge. other laws, such as environmental law, may be more useful in addressing structural conditions for emergence. changes in land use and agricultural intensification in developing societies are major drivers of eid. however, the cost of laws that restrict development may be greater global health inequities, with consequential effects for health outcomes. in order to clarify eidrelated legal tensions between economic development and health security, a more explicit recognition is needed of who are the primary beneficiaries and who bears the costs of a one health approach to eids [ ] . legal clarity around the frameworks designed to protect populations from eids is critical to providing an enabling infrastructure to co-ordinate and support the one health-based work of policymakers, development planners, human and animal health-workers and biosecurity agencies. the health of humans, animals, and ecosystems are interconnected. a one health approach promises a better understanding of how to prevent and control eids at the human-animal-ecosystem interface. however the socio-political, ethical and legal challenges of eids illustrated above highlight how responses to infectious disease threats are intrinsically value laden. when a new infectious pathogen such as hendra or nipah virus first appears, or a known threat such as rabies or ebola encroaches on a new setting, there is limited scientific evidence or past experience to guide decisions or determine whether a planned response will be proportionate. vastly different interpretations of eid events and their likely outcomes might be supported by the available data. policymakers and practitioners therefore have little guidance as to what they should do when faced with a nascent infectious disease threat, only what they can do. as others [ ] [ ] [ ] have cogently argued, they must therefore ask themselves: whose health is being prioritized; which public and which good are we seeking to protect? notwithstanding recognition of a need for complementary work on values-based questions that inevitably surround eid risks and eid control, the adoption of the one health approach, so far, has not included development of a comprehensive, ethically-informed policy and implementation framework; this has limited its practical utility [ , ] . despite rhetorical and some financial support for one health as the guiding ethos by which to address interconnected human, animal and environmental health issues, its impact will be minimal unless implications of uncertainty on, and potential conflicts between, human values and political processes are recognised and articulated. any attempt to address these ethical and normative dimensions must take into account the dynamic nature of eid risk management. a policy that seems reasonable today may be inappropriate tomorrow, in light of new evidence. and when situations are uncertain, decision-makers inevitably fall back on their values. therefore, a solid framework based on shared values is needed to support decision-making surrounding eids when "evidence" isor may beunreliable, and rapidly changing or fluid. what is needed to guide a one health approach to eids? to successfully meet the challenges described above, particularly the necessity to align eid policy with public values, a one health approach needs to engage in the following. (i) social science and economic research to help catalogue and describe the drivers, mechanisms and social and political configurations through which eids become threats to human, animal and ecological health [ , ] . the complex connections between individual social needs and the local socioeconomic context of affected or at-risk communities, need to be understood and addressed by policymaking processes. this should ensure that manifest injustice, livelihood-based decisions and other social and cultural factors do not undermine the effectiveness of favoured control measures. without adequate knowledge of specific local arrangements, there is a danger that insufficiently nuanced or unified approaches to eids will actually undermine the heterogeneous relationships and contingent practices that make health possible in circumstances of structural disadvantage [ , ] . the social sciences are analytically broader and more policy focussed than the natural sciences. whereas the natural sciences tend to frame infectious disease threats narrowly as matters of biological integrity and security, such that barrier technologies and hygiene practices dominate the logic of interventions [ ] , social science approaches go beyond this. building social scientific evidence for use in conjunction with natural scientific evidence about eids aligns with the growing realization that eid emergence is as much about the social and economic configuration of capital flow as it is about the biological features of host-pathogen interactions. current approaches to the economic and structural drivers of eid emergence still presume that state and market neoliberalism is part of the natural order, even as evidence is mounting that these systems of development are central to the problem [ , ] . moreover, the current emphasis on microbiology and focus on newer molecular techniques to characterise pathogens, is drawing attention away from developing better understandings of the environmental, economic and social drivers of eids. while this is understandable given the desire for vaccines and drugs to solve eids, if one health researchers and practitioners broaden their approach to causality to include upstream, social and economic systemic causes, questions and issues that have been traditionally bracketed or thought best avoided will become central to the cross-sectoral collaboration implied by one health. framework (ohaf) needs to be pursued. such a framework would catalogue case-based experiences and reflect the particular dynamics of specific eids, and promote inter-sectoral collaboration and knowledge synthesis, including integration of information about social, cultural and economic impacts, control measures and uncertainty [ , ] . the framework would serve as a prompt to ensure that minority perspectives are represented and all relevant concerns are considered. an ohaf could provide a rubric for comparisons between outbreaks. this would allow the inherent complexities of economic and societal responses to eids to be compared, to inform policy processes. it is vital for discussions about eid prevention and control to have this kind of sound empirical foundation, because uncertainty and media coverage have the potential to drive bad policy. development of an ohaf could be facilitated by adopting well established and methodically rigorous processes such as framework analysis, produced by the national centre for social research (uk) [ ] , or multi-criteria decision analysis [mcda] developed within the field of decision science [ ] . in the first instance framework analysis would allow for systematic incorporation of the perspectives and contributions of different scholarly disciplines and expert stakeholders. framework analysis facilitates movement between different datasets, thematic areas, theoretical resources, and levels of abstraction without loss of conceptual clarity [ ] . the framework method is used to organize and manage research and interpretation through the process of summarization, which is codified into a robust and flexible matrix that allows the policymaker/researcher to analyze data both by case and theme. it is commonly used in areas such as health research, policy development and program evaluation. equally, mcda methods offer an alternative and potentially complementary approach to ohaf development. comprised of a suite of analytic strategies, mcda have been shown to be valuable tools for prioritization and decision-making in animal and human health [ ] . mcda provides a framework to compare policy alternatives with diverse and often intangible impacts, which can be particularly useful in determining and justifying the prioritization and mobilization of limited research and public health resources [ , ] . (iii)genuine processes of public engagement across the developed and developing world are also essential to a successful one health approach. these processes are not so much about engaging in deliberative democracy for policy decision-making, as about defining the principles and values that should guide decision-making. this means procedural inclusiveness alone is not enough to ensure transparency and reflexivity, to capture people's preferences and to effectively communicate with the public [ ] . the successful implementation of the one health approach to eids will depend on public trust and cooperation. public support for unpalatable measures is more likely if citizens understand the issues, and policy implementation reflects community values and preferences. to this end, citizens' juries have been employed in the uk, australia, the us and elsewhere [ ] [ ] [ ] [ ] to explore similar issues and identify citizens' preferences. they represent informed public opinion better than other social research methods (e.g. surveys or focus groups) because they give participants factual information, bring them into a structured and constructive dialogue with experts, provide them with time to reflect and deliberate, and allow them to represent their views directly to policymakers. to be successful, one health needs to be about more than disease prevention and control. the dynamic, unpredictable effects and risks to peoples' lives of eids necessitate a public health and biosecurity infrastructure equipped to address the ethical problems that arise. eid management must therefore be based on normative principles as well as local knowledge, operational experience and disease-specific scientific and economic evidence. this means that governments and policy-makers need to explain and justify the values that underlie decision-making and engage the public in discussions about ethical choices, so that when difficult decisions arise in the face of uncertainty, they will be accepted as fair and essential for the public good [ ] . this necessitates that the guiding values and likely ethical choices need to be articulated in a formal statement in advance, as in the heat of emerging health threat, decision makers will be under pressure from many sources to 'do something quickly'. (v)integration of an ohaf and spv with the ihr and relevant national health and biosecurity legislation is essential so that policymakers and practitioners can dynamically test their decision-making. our response should of course be based on the best scientific evidence, but eids are not just scientific issues, they also have significant social, ethical and animal rights dimensions. experiences of infectious disease threats such as bse/vcjd and sars indicate that there have been problems combining evidence and human values at both local and policy levels [ , ] . the communicability of diseases between species raises social, ethical and legal issues that have not been clearly elucidated or adequately addressed. our response to nonhuman animal disease is not determined solely by bio-scientific knowledge; the way people and animals live with and amongst each other is also shaped by social norms, economic imperatives and human values. in matters of public health it is no longer sufficient to ask what works and what is the strength of the evidence; we also need to ask ethical questions about how we should seek to live, and what is the right thing to do [ ] [ ] [ ] . consensus about the best approaches to eid control and prevention are not always possible, however an agreed set of guiding principles and values can be a means to ensure dialogue, if not always agreement. the development of an ohaf and spv will also promote clearer communication about public risk. significant eid threats have major implications for distribution of scarce resources, access to and regulation of health services and maintenance of social order. as described above it is also clear that policy and legal responses to eid threats are often highly politicised and compromised by failure to communicate clearly with the public. policymakers responsible for responding to disasters such as eids typically find that there is a dissonance between transparency that may appear alarmist versus withholding information to avoid panic. regardless of advice, people will make their own decisions based on their interpretation of available information, from formal and informal channels. so public communication, before and during a public health emergency, is frequently as important as political decisions and regulatory changes [ , ] . this means that, to be effective, a one health approachlike any eid policymust deal with scientific uncertainty, whilst addressing the socio-political, ethical and legal dimensions of effective health communication and intervention strategies [ ] . by exposing decision-making processes to reveal the scientific and normative uncertainties and ethical complexities, the introduction of an ohaf and a spv into one health theory and practice may incorporate iterative deliberation and learning into eid policy processes. (vi)finally, one health must be about genuine reform rather than merely rhetoric. a one health approach rests on the assumption that the cross-sectoral integration of expertise, research methodologies and public health infrastructure will inevitably improve capacity for disease-risk prediction and effective intervention. however, calls for increased intersectoral co-operation by public health practitioners, clinicians, scientists and policy-makers are not a new phenomenon. for example in the s advocates of "new public health" called for health authorities to turn their attention to the social, economic and environmental factors that affect healthrequiring the realignment and policy integration of health departments with other government agencies [ , ] . unfortunately in this case as others, attempts at promoting inter-sectoral approaches rarely move beyond rhetoriceven when driven by the best intentions and supported by substantial resources [ ] [ ] [ ] . the problem is that arguments that promote the need for greater co-operation between sectors tend to focus on the likely benefits of collaboration rather than what reform would entailthat is, what needs to be done organisationally and politically to achieve the desired outcomes [ ] . established 'sectors'whether orientated towards human or animal health, agriculture or the environmenthave genealogies, traditions and rationalities of "what we are here for" that have been shaped by social, political and administrative processes [ ] . as institutions, they are philosophically and structurally resistant to change that diverts resources and re-orients practices away from their own sectoral priorities [ ] . in essence, they have their own constituencies to serve. as a consequence, establishment and implementation of mechanisms that enhance information-sharing, collaboration and inter-sectoral co-operation, such as working groups and interdepartmental committees, have rarely delivered the outcomes promised in the past. responses to bse/vcjd in the uk [ ] , hpai in south east asia [ ] , and recent case studies of one health programs in uganda [ ] , suggest that more work is needed to coordinate implementation and overcome sectoral interests. the complexity of the problems posed by eids mean that organising effective control and prevention programs will require genuine cross-sectoral integration and, potentially, re-sectoring of some institutional and professional responsibilities [ ] . and as the recent ebolavirus disease outbreak illustrates, there must also be sustained social and political willingness to achieve control. if one health is genuinely the way forward, as we believe it is, then we should do more than talk about its potential benefits. without genuine cross-sectoral reform and a radical broadening of the scope of its inquiry into how specific social, cultural and spatial configurations promote the risks of eid emergence, one health is in danger of becoming merely a rhetorical strategy to avoid conflict between its core disciplines, whereby practitioners, researchers and policymakers will espouse the methodological and moral case for interdisciplinary collaboration yet remain in their silos [ ] . even if these barriers are overcome the one health approach will only succeed if it explicitly acknowledges local contingent and contextual dimensions of disease risk and disease expression and the political impacts of scientific uncertainty, while also seeking to accommodate the values and preferences of 'at risk' and affected individuals. further, we suggest that decision making around eids requires an ethical framework that reflects the values of affected and 'at risk' communities, privileges justice, takes account of human flourishing, protects animal health and welfare and is developed in consultation with relevant stakeholders and the public. eid risk management is a major global public health issue to which one health represents a promising approach, but its potential benefits have not been fully realised [ , ] . despite recognition that the social and cultural dimensions are critical to the success of one health, social scientists are yet to play a central or substantive role in shaping research programs and interventions [ , ] . at the same time as the literature on the ethics of pandemic responses and preparedness continues to grow, the one health approach to eids has received little formal ethical consideration. even the most ethically attuned existing frameworks for biosecurity and infection prevention and control provide only general operational principles that do not guide actions in times of uncertainty. if one health is to be meaningful − let alone successful − more attention must be paid to how these different types of knowledge are brought together and brought to public attention. effective responses to eids are likely to be delayed or precluded unless all the socio-political, ethical and legal implications are articulated, publicly 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a framework for health promotion does health promotion need a code of ethics? early response to the emergence of influenza a (h n ) virus in humans in china: the central role of prompt information sharing and public communication the new public health what is the "new public health joining up or pulling apart? the use of appraisal to coordinate policy making for sustainable development what's new about the "new public health"? learning lessons from past mistakes: how can health in all policies fulfil its promises? the significance of 'sectors' in calls for urban public health intersectroralism: an australian perspective one world-one health and neglected zoonotic disease: elimination, emergence and emergency in uganda ecological aspects of hendra virus cross-species virus transmission and the emergence of new epidemic diseases the hendra virus report: an investigation into agency responses to hendra virus incidents between new directions in conservation medicine: applied cases of ecological health henipaviruses: unanswered questions of lethal zoonoses the nipah virus outbreak and the effect on the pig industry in malaysia the cost of canine rabies on four continents review of rabies epidemiology and control in south, south east and east asia: past, present and prospects for elimination development of a novel rabies simulation model for application in a non-endemic environment australian veterinary emergency plan (ausvetplan) review of bats and sars an update on the assessment and management of the risk of transmission of variant creutzfeldt-jakob disease by blood and plasma products the work was funded by nhmrc grant # and seed funding from the marie bashir institute for infectious disease and biosecurity and the school of public health at the university of sydney. the funding source has had no involvement in how the paper was interpreted or written. the authors declare that they have no competing interests.authors' contributions cd led the conceptualization, review, critical analysis and drafting of the article. jj, gg, ik, aw, mw, and cs all made significant contributions to the critical analysis and drafting of the paper. jj and cd led the final preparation of the paper for submission. all authors read and approved the final manuscript.• we accept pre-submission inquiries • our selector tool helps you to find the most relevant journal submit your next manuscript to biomed central and we will help you at every step: key: cord- -r fccx authors: ogle, h.l.; sharma, r.k. title: who must take responsibility for the health of the profession? us date: - - journal: public health doi: . /j.puhe. . . sha: doc_id: cord_uid: r fccx nan letter to the editor who must take responsibility for the health of the profession? us this letter is not a commentary on the specifics of pandemic responses by nations or healthcare services. this is a wholly inward reflection as to one vital way in which we, as healthcare workers, can and must take control of the controllable. it may be an unfortunate benefit if instigated now due to the pandemic-induced anxieties, but benefit, nonetheless. when their profession is health, it should be surprising that many doctors do not adequately manage their own. however, to most doctors, this is an accepted sacrifice superseded by the long hours and stressful nature of the work. with few spare hours, exercise cannot be made a priority, and almost one in four doctors engage in absolutely no physical activity. in turn, it cannot then be a shock to see that . % of healthcare professionals are obese. across the profession, the benefits of an active lifestyle and healthy diets are pushed unapologetically. but why does it seem so fundamentally unachievable in ourselves? is it as suggested, a tacit inability, or is it in fact a more blatant hypocrisy? in recent times, health has dominated all aspects of our lives. the global population has become acutely aware of the existence of comorbidities and the negative consequences of poor health. from the very start, it has been apparent that those worst affected by coronavirus disease (covid- ) suffer from underlying health conditions. recent figures state that % of total deaths from the virus have occurred in patients with at least one comorbidity. given the innate vulnerabilities of working in health care at such a time, the additional susceptibility owing to ill-health is just one factor completely within our control. healthier lifestyles are needed across the entire profession, and this is a learning opportunity that we cannot afford to ignore. the pandemic has provided abundant proof that this is a matter of life or death. promoting a healthy lifestyle within the profession must be integral as we forge the route into the 'new normal' of healthcare provision. this is before mentioning the innumerable benefits for all other parties, including employees, from longevity in the workforce through to improved patient adherence. we concede that there is a certain degree of optimism that change will be so easy to come by, but there is already evidence that small and cumulative changes make vast differences. action, quite simply, must be taken. the onus, for this at least, is on us. do as we say, not as we do?" the lifestyle behaviours of hospital doctors working in ireland: a national cross-sectional study obesity prevalence by occupation in washington state, behavioral risk factor surveillance system covid- : underlying metabolic health in the spotlight the effectiveness of worksite nutrition and physical activity interventions for controlling employee overweight and obesity key: cord- -zol k p authors: hill-cawthorne, grant; negin, joel; capon, tony; gilbert, gwendolyn l; nind, lee; nunn, michael; ridgway, patricia; schipp, mark; firman, jenny; sorrell, tania c; marais, ben j title: advancing planetary health in australia: focus on emerging infections and antimicrobial resistance date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: zol k p with rising population numbers, anthropogenic changes to our environment and unprecedented global connectivity, the world economic forum ranks the spread of infectious diseases second only to water crises in terms of potential global impact. addressing the diverse challenges to human health and well-being in the st century requires an overarching focus on ‘planetary health’, with input from all sectors of government, non-governmental organisations, academic institutions and industry. to clarify and advance the planetary health agenda within australia, specifically in relation to emerging infectious diseases (eid) and antimicrobial resistance (amr), national experts and key stakeholders were invited to a facilitated workshop. eid themes identified included animal reservoirs, targeted surveillance, mechanisms of emergence and the role of unrecognised human vectors (the ‘invisible man’) in the spread of infection. themes related to amr included antimicrobial use in production and companion animals, antimicrobial stewardship, novel treatment approaches and education of professionals, politicians and the general public. effective infection control strategies are important in both eid and amr. we provide an overview of key discussion points, as well as important barriers identified and solutions proposed. with rising population numbers, anthropogenic changes to our environment and unprecedented global connectivity, the world economic forum ranks the spread of infectious diseases second only to water crises in terms of potential global impact. addressing the diverse challenges to human health and well-being in the st century requires an overarching focus on 'planetary health', with input from all sectors of government, non-governmental organisations, academic institutions and industry. to clarify and advance the planetary health agenda within australia, specifically in relation to emerging infectious diseases (eid) and antimicrobial resistance (amr), national experts and key stakeholders were invited to a facilitated workshop. eid themes identified included animal reservoirs, targeted surveillance, mechanisms of emergence and the role of unrecognised human vectors (the 'invisible man') in the spread of infection. themes related to amr included antimicrobial use in production and companion animals, antimicrobial stewardship, novel treatment approaches and education of professionals, politicians and the general public. effective infection control strategies are important in both eid and amr. we provide an overview of key discussion points, as well as important barriers identified and solutions proposed. the st century confronts us with profound global challenges such as food, water and energy security, reduced resilience of our planet's life-giving ecosystems and threats from emerging and antimicrobial-resistant infections. according to the world economic forum, the spread of infectious diseases is now ranked second only to water crises as the global risk with the greatest likelihood and potential impact, while the one world one health concept recognises that human and animal health are intimately linked and ultimately dependent on healthy ecosystems. in , the rockefeller foundation invested us$ million to establish the pillars of a new discipline called planetary health, which identifies the need for integration of social, economic, environmental and health knowledge. in a similar vein, the wellcome trust launched the our planet, our health initiative, investing £ million over years to explore the link between human health and environmental change. the united nations' sustainable development goals (sdgs) also emphasise the dependence of human health on the resilience of the planet's ecosystems, with specific targets that prioritise and focus global action. within australia, the 'foundations for the future: a long-term plan for australian ecosystem science' report, published in , stated that: 'our natural and managed ecosystems form the world we live, play and work in; the settings for our industry; and the distinctive natural heritage that characterises the australian nation. they are the basis of our current and future prosperity, and our national well-being'. however, a national summary box ► the emergence and spread of infectious diseases, including antimicrobial-resistant infections, pose a major health security threat. ► a more holistic approach to emerging infectious diseases (eid) and antimicrobial resistance (amr) is essential to encourage 'resilience thinking'. the main themes identified were: animal reservoirs of emerging human pathogens, pathogen surveillance, mechanisms of disease emergence and disease spread by asymptomatic individuals (the so-called 'invisible man'). tables and summarise relevant participant responses. the severe acute respiratory syndrome coronavirus (sars-cov) outbreak in highlighted the importance of animal reservoirs as a source of human infection. henipavirus outbreaks, including hendra on the australian eastern seaboard and nipah in malaysia and bangladesh, demonstrated the importance of bats as viral reservoir species and of domestic animals (horses and pigs, respectively) as amplifying hosts. for the middle east respiratory syndrome coronavirus (mers-cov), domestic camels have been implicated as the likely amplifying hosts. fortunately, serological testing of camels in australia, which is home to the largest population of wild camels in the world, has revealed no evidence of mers-cov infection to date. bats may also carry ebolavirus, but its environmental reservoirs remain uncertain. in general, the inter-relationships between animal reservoirs and amplifying hosts, as well as the circumstances that lead to pathogen overspill or backspill between wildlife, livestock and humans are poorly characterised. in the absence of systematic pathogen surveillance in wildlife and domestic animals, human cases often act as bmj global health across the usa. the risk of infections spreading from wildlife reservoirs into human populations is exacerbated by the expansion of agriculture and mining into natural environments, road infrastructure, deforestation, subsistence hunting and co-location of wild and domestic animals in so-called wet markets. strategically, targeted surveillance of the environment, domestic and wild animals, infection vectors and vulnerable human populations will facilitate early detection and better control of disease emergence risk. the importance of pathogen surveillance has been emphasised by both the ebola interim assessment panel chaired by dame barbara stocking and the independent panel on the global response to ebola chaired by professor peter piot. the stocking report recognised poor implementation of international health regulations (ihr), which were approved by the world health assembly in , as well as the need for global solidarity to build local capacity, which has been incorporated in target .d of the sdgs: 'strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks'. ihr implementation requires strong government commitment to establish and maintain public health laboratory and service provider capacity. the us committed us$ billion towards the global health security agenda, while the uk created a £ billion fund in partnership with the bill and melinda gates foundation to tackle malaria and other infectious diseases. the australian government committed $a million over years - to the indo-pacific centre for health security, assisting core capacity strengthening and complementing who's regional strategy for emerging diseases and public health emergencies in the asia-pacific (asia pacific strategy for emerging diseases; apsed iii ). the synthesis of data on the ecology and evolutionary biology of various organisms provide enhanced understanding of pathogen emergence, but information on the social mechanisms that underpin disease outbreaks and persistence remains rudimentary. for example, the reasons for increasing rates of human non-typhoidal salmonellosis in australia (noted at the workshop), at a time when rates were falling in most comparable countries, were poorly understood. integration of food, animal and human surveillance data could provide the insight needed to improve control of these infections. the impact of climate change, particularly on water and vector-borne diseases, was highlighted as a key concern. viruses spread by aedes aegypti and a. albopictus mosquitoes (zika, dengue and chikungunya) pose a significant risk to global health. so far, australia has successfully restricted these mosquito populations, but the likelihood of their permanent establishment will increase with climate change. mosquito surveillance in australia is undertaken on a state-by-state basis with coordination by the national arbovirus and malaria advisory committee. more comprehensive and better standardised surveillance programmes will facilitate accurate mapping of mosquito populations and better tracking of endemic and imported viruses. the 'invisible man' presymptomatic or asymptomatic individuals can unwittingly spread infection. salient examples include the spread of hiv from asymptomatically infected individuals, the hours presymptomatic period during which patients with influenza are infectious and unrecognised colonisation with multidrug-resistant organisms. outbreak control strategies usually depend on syndromic diagnosis and cluster identification to guide intervention strategies. when outbreaks are fuelled by unrecognised human vectors, the importance of routine infection control precautions becomes evident and pre-emptive control measures such as quarantine of high-risk individuals or large-scale social distancing may be appropriate. such measures are difficult to implement. risk assessment and modelling to predict the most likely eventualities in advance and develop realistic scenarios to aid public health response preparedness are important to guide mitigation strategies. strengthening of public health systems, especially in low-income and middle-income countries, is essential to achieve core ihr capacities. the australian government's health for development strategy - articulated most of the important elements required for a comprehensive regional response, but australia's bmj global health international aid budget has declined to its lowest level in many decades; falling well short of international targets. effective implementation of the joint external evaluation process in the asia-pacific region has provided a valuable overview of country-level preparedness, but it needs to be combined with the world organisation of animal health (oie) evaluation of performance of veterinary services assessment to improve one health surveillance, while ongoing monitoring is essential to ensure that identified capacity gaps are addressed and best practices shared. it is predictable that eids will escalate in frequency. although much effort has been expended in developing pandemic preparedness policies, recent experiences with sars and mers-cov demonstrated that even the most advanced medical systems require continued vigilance linked to careful scenario response planning. [ ] [ ] [ ] epidemic outbreaks, or even the perceived threat of an epidemic, usually lead to a flurry of activity, but lessons learnt and interim policies developed are rarely consolidated during interepidemic periods. successful policy implementation requires an expert panel that represents all relevant disciplines, to work with the commonwealth office of health protection to draft national guidelines and monitor implementation of actions to reduce the likelihood and negative impact of eids. it could also oversee the drafting of generic research proposals to test interventions and generate enhanced insight during epidemic outbreaks. methodologies for better decision-making during emergencies require refinement. [ ] [ ] [ ] the rockefeller-lancet commission identified three important strategies, adopting a threshold approach, scenario planning and resilience thinking. these require pre-emptive scoping of relevant risks, as well as possible scenarios and outcomes associated with identified courses of action. effective public communication in times of uncertainty poses a major challenge. the australian media were more measured than media outlets in the usa during the ebola virus outbreak, but news reports still generated considerable public anxiety. detailed scenario planning will help to identify priority actions and communication strategies to reassure the public that the situation is under control and that perceived risks are manageable. optimal communication will require close liaison between researchers, public health officials (for human, animal and environmental health), policymakers and the media. within australia, there is no formal framework within academic institutions or government to facilitate and support cross-disciplinary collaboration, although the national framework for communicable disease control does encourage a one health approach to pandemic preparedness. increased amr awareness has been encouraging, but like climate change progress is slow, given the multiple vested interests and differences in risk/benefit perception. much can also be learnt from the roadmap developed by the us centers for disease control and prevention (cdc) to assist one health operationalisation. the australian national antimicrobial resistance strategy - , jointly developed by the departments of health and agriculture and water resources, represents an example of how these silos can be linked, but implementation remains challenging. table summarises participant responses to open-ended questions focused on amr. the main discussion themes included antimicrobial use in production animals, amr in companion animals, antimicrobial stewardship and public education. table provides an overview of key barriers and potential solutions identified. the ecological effects of antimicrobial selection pressure, including its effects on the human and animal microbiome, are poorly understood. antimicrobial use in production animals has been restricted in australia following the recommendations of the swann report. when avoparcin use in feedlot cattle was shown to increase the prevalence of enterococcus faecium resistance to vancomycin (a glycopeptide antibiotic used for the treatment of human infections), it was voluntarily withdrawn from the australian market. fluoroquinolones were never approved for use in production animals in australia, which probably explains the low levels of fluoroquinolone resistance observed in campylobacter, salmonella and escherichia species compared with other countries where agricultural use is unrestricted. globally, the pork and chicken industries are the biggest users of antimicrobials. recent descriptions of highly resistant bacteria found on chicken and swine farms in china, linked to outbreaks of human infection with bacteria containing similar plasmid-mediated resistance, offer a stark example of the health risks associated with unregulated antimicrobial use in production animals. however, it was acknowledged that the responsible use of antimicrobials to address concerns about food security and animal welfare require careful consideration. companion animals are important to australians; % of households own pets and the pet industry contributes nearly us$ . billion to the australian economy, employing people. the health benefits of pet ownership are estimated to save the healthcare system approximately us$ . billion per year. despite the intensity of interaction, there has been surprisingly little research into the transmission of amr between pathogens of humans and their pets. a better understanding of antimicrobial use in companion animals is needed, since there is no regulatory guidance and pets fall outside the agriculture and health portfolios. australian doctors prescribe more than twice the amount (in defined daily doses per population per day) of antibiotics compared with their counterparts in the bmj global health table responses to open-ended questions on antimicrobial resistance (amr) nightmare scenario ► global spread and dominance of totally antimicrobial resistant pathogensreturning to the preantibiotic era priorities for future research/policy ► environmental impact of antimicrobial use in humans, animals and crops ► emerging bacterial resistance to biocides and disinfectants. ► amr transmission from and to companion animals. ► balancing food production capacity with amr concerns. ► need for comprehensive amr surveillance; understanding the selection, expansion and spread of multidrug-resistant mobile genetic elements (mapping the mobile gene pool). ► antibiotic stewardship-understanding why doctors prescribe and patients demand, antimicrobials inappropriately. ► better infection control within health and aged care facilities. ► point-of-care diagnostics (including rapid species identification and drug susceptibility testing). ► use of highly selective bacteriophage therapy. ► adaptive clinical trial designs for rapid assessment of multidrug regimens ► alternative drug development funding models that considers the public good. ► non-antimicrobial approaches to controlling infections. ► are there effective treatment strategies that will reduce selective pressure and on-going evolutionary 'escape', such as increasing bacterial susceptibility to immune attack or reducing the risk/impact of invasive bacterial infection only? ► what are the key characteristics of a healthy microbiome and the short and long term impacts of antimicrobial induced changes? issues that require public consultation ► restricting antimicrobial access to reduce inappropriate use, for example stronger regulation or increases in price ► how best to educate the general public and prescribers about the dangers (personal and environmental) of inappropriate antimicrobial use. ► balancing animal and human welfare considerations. ► balancing distributive justice and community versus individual cost-benefit. amr, antimicrobial resistance. netherlands. at least % of prescriptions are judged by experts to be clinically inappropriate, inadequate or unnecessary. litigation risk aversion, diagnostic uncertainty, time pressure and perceived patient demand are among the reasons why doctors overprescribe antibiotics. evidence of previously unrecognised harm related to impacts on the human microbiome, as well as the social and ecological harm from amr, should inform development of novel strategies to optimise antimicrobial use. a public policy research agenda, informed by social scientists and psychologists, should explore how best to reform policy settings, devise appropriate incentives and disincentives, develop innovative public and professional education programmes and use social media to improve public understanding and influence responsible regulation expectations. both the general public and professional groups require an enhanced appreciation of basic infection control principles. based on scenarios of increasing amr prevalence for six pathogens, it has been estimated that by , million lives per year and trillion usd of economic output may be lost due to amr infections. a divisive debate has focused on the relative impacts of human versus animal or agricultural use of antimicrobials, but constructive collaboration is essential to elucidate and mitigate the key drivers of amr. a major advance in promoting a one/eco health approach to amr in australia was achieved through the joint support of the australian chief medical and veterinary officers to develop and implement a national amr strategy. this is the first joint ministerial initiative between the australian government departments of health and of agriculture and water resources. the who's antimicrobial resistance: global report on surveillance ( ) identified a policy package with broad goals that included strengthened surveillance and laboratory capacity. however, without adequate funding and accountability measures, such farsighted policies will continue to fall short, especially in the asia-pacific region where antimicrobial use is essentially unregulated and strong financial incentives exist to retain the status quo. the who western pacific region's action agenda is a step towards tackling these problems, but the agenda includes no plans for bmj global health lack of funding for cross-disciplinary research was identified as a significant barrier; participants believed that this was exacerbated by the separation of the two major australian public research funding bodies-the national health and medical research council (medical) and the australian research council (non-medical). breaking down traditional medical, veterinary and biological research silos is crucial, with dedicated funding to support cross-disciplinary initiatives. few new antimicrobials have been developed in recent years, as antimicrobials do not deliver attractive returns on investment. private-public partnerships have been used with success to develop vaccines for neglected diseases, but this requires generous philanthropic support. new economic models should reward antimicrobial discovery (or novel non-antibiotic approaches to reducing amr) as a public good, delinking the return on investment from the volume of sales. the association of british pharmaceutical industries antibiotics network has suggested an insurance-based model that guarantees an annual license fee, providing a more predictable return on investment. while the development of new antimicrobial drugs is important in the short term, history has shown that resistance will develop frameworks for the optimal and ethical application of new technologies, such as social network surveillance and advanced pathogen genomics. provide leadership within the asia pacific region and link with international efforts ► strengthen linkages with and support of regional who offices (western pacific and southeast asia), especially the 'health security and emergencies' and 'communicable diseases' sections and other regional mechanisms and forums, including the south pacific commission, the east asia summit and the asia pacific economic cooperation, as well as global initiatives such as global health security agenda and the development banks. ► encourage adequate funding of dfat's regional health security strategy. ► link with one/eco/planetary health communities in other countries, encourage a 'united front' and support international efforts *this was recently completed, but many of the core elements remain to be executed. develop in response to selection pressure and spread without appropriate infection control measures. alternative therapeutic strategies, such as bacteriophage treatment may be successful if linked to rapid and accurate pathogen identification. attempts to reduce selection pressure fuelled by indiscriminate microbial killing, includes highly targeted bacteriophage-based approaches, modification of disease causing microbes to make them more susceptible to immune attack and developing strategies that prevent or selectively treat invasive disease only. rapid point-of-care tests that differentiate viral and bacterial infections, and provide antimicrobial susceptibility profiles, would assist more targeted use of conventional antibiotics. the challenge posed by eids and amr requires careful consideration of effective mechanisms for prevention and response. table summarises the processes and activities identified for a coordinated australian response to the threat of eids, supported by the recently released national action plan for health security. while the national amr strategy emphasises bmj global health the need for a coordinated one health approach, implementation within existing government structures remains challenging without significant internal reform. public education should also target politicians and key decision-makers, since implementation requires strong political will and requisite funding. global risks one world, one health: beyond the millennium development goals influenza coordination, unicef, the world bank safeguarding human health in the anthropocene epoch: report of the rockefeller foundation-lancet commission on planetary health wellcome trust launches our planet, our health initiative sustainable development goals [internet]. sust aina bled evel opment. un. org foundations for the future: a long-term plan for australian ecosystem science from public to planetary health: a manifesto ecological dynamics of emerging bat virus spillover antibodies against mers coronavirus in dromedary camels absence of mers-cov antibodies in feral camels in australia: implications for the pathogen's origin and spread a new approach for monitoring ebolavirus in wild great apes emerging infectious diseases of wildlife--threats to biodiversity and human health west nile virus: success of public health response underlines failure of the system ecology of zoonoses: natural and unnatural histories who. stocking b. final report of the ebola interim assessment panel will ebola change the game? ten essential reforms before the next pandemic. the report of the harvard-lshtm independent panel on the global response to ebola fact sheet: the global health security agenda chancellor george osborne and bill gates to join forces to end malaria aspx? w= tb cagpkpx% fls k% bg zkeg% d% d pacific strategy for emerging diseases and public health emergencies (apsed iii): advancing implementation of the international health regulations dengue and climate change in australia: predictions for the future should incorporate knowledge from the past australian department of foreign affairs and trade a new strategy for global development improving emergency preparedness and response in the asia-pacific public health measures to control the spread of the severe acute respiratory syndrome during the outbreak in toronto mers-cov outbreak following a single patient exposure in an emergency room in south korea: an epidemiological outbreak study developments in non-expected utility theory: the hunt for a descriptive theory of choice under risk an axiomatic approach to choice under uncertainty with catastrophic risks decision-making under great uncertainty: environmental management in an era of global change national framework for communicable disease control department of health. uk five year antimicrobial resistance strategy tackling drug-resistant infections globally one health": a policy perspective commonwealth of australia. responding to the threat of antimicrobial resistance report of the joint committee on the use of antibiotics in animal husbandry and veterinary medicine avoparcin used as a growth promoter is associated with the occurrence of vancomycin-resistant enterococcus faecium on danish poultry and pig farms low-level fluoroquinolone resistance among campylobacter jejuni isolates in australia control of fluoroquinolone resistance through successful regulation global trends in antimicrobial use in food animals emergence of plasmid-mediated colistin resistance mechanism mcr- in animals and human beings in china: a microbiological and molecular biological study species shift and multidrug resistance of campylobacter from chicken and swine, china, - australian companion animal council health benefits and health cost savings due to pets: preliminary estimates from an australian national survey australian commission on safety and quality in health care. antimicrobial prescribing practice in australia cultures of resistance? a bourdieusian analysis of doctors' antibiotic prescribing antimicrobial resistance: global report on surveillance . who. world health organization action agenda for antimicrobial resistance in the western pacific region s partnership model association of the british pharmaceutical industry. antimicrobial resistance. house of commons science and technology select committee australia's national action plan for health security aust-nat-action-plan-health-security- - . pdf . marais bj. ethics; the third dimension acknowledgements the authors would like to thank kerri anton for developing and designing the layout and structure of the workshop, and christine aitken for event organisation. we also thank participants from all the different sectors that took part, including martin kirk (national centre for epidemiology & population health at the australian national university, canberra, australia), elizabeth harry (the ithree institute, the university of technology sydney, australia) and ben howden (microbiological diagnostic unit public health laboratory, the doherty institute for infection and immunity, melbourne, australia) who contributed to the closed group discussion. the meeting was supported by the university of sydney contributors bm and gh-c conceptualised the manuscript and led the workshop. all authors contributed to the workshop and assisted with the development of the content and review of the manuscript.funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. competing interests none declared.patient consent for publication not required.provenance and peer review not commissioned; internally peer reviewed. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc . ) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. see: http:// creativecommons. org/ licenses/ by-nc/ . /. key: cord- - x idzn authors: ibrahim, mohamed izham mohamed; wertheimer, albert i. title: introduction: discovering issues and challenges in low- and middle-income countries date: - - journal: social and administrative aspects of pharmacy in low- and middle-income countries doi: . /b - - - - . - sha: doc_id: cord_uid: x idzn there are gaps and challenges in pharmacy practice in developing countries and possible solutions for various pharmacy stakeholders. health and public health are essentials for development. the weak global economy has hindered progress toward the sustainable development goals. many people are still living in poverty with poor health status and inadequate healthcare. poor health and pharmaceutical sectors in a country will increase the vulnerability of the country and leaves the society at risk. effective public health interventions can save hundreds of millions of lives. pharmacy system is one of the core components in a healthcare system, and pharmacists play a very important role. this book sheds light on various topics that individually and in combination determine the status of pharmacy practice in individual countries. this book incorporates multiple data sources and when outliers are discovered, that may be called to the attention of the reader. this book also provides knowledge and understanding about social and administrative aspects of pharmacy in healthcare in low- and middle-income countries. reminded us that the major obstacle to the establishment of pharmacy administration is due to the negative attitudes and imbalanced focus and emphasis between professionalism versus business orientation that are inherent in pharmacy practice. the book that was edited by fathelrahman, mohamed ibrahim, and wertheimer ( ) , explored the pharmacy practice in developing countries in asia, africa and latin america and provided an excellent overview of pharmacy practice. the book also provides us with gaps, challenges and possible solutions for various pharmacy stakeholders in the developing countries. there is a great deal of work that needs to be done by the pharmacy stakeholders in order to improve the pharmaceutical health services for fulfilling the needs of the society. it is understood that under the sustainable development goals (sdgs), every country is in need for development (united nations, ). yet unfortunately, the weak global economy has hindered progress toward the sdgs, especially for countries with lower economic level. development is everyone's problem and everyone's dream. there is no clear definition of the terms "developed and developing countries" or no consensus on how to categorize these countries. developing countries include, in decreasing order of economic growth or size of the capital market: newly industrialized countries, emerging markets, frontier markets, and least developed countries. list of developing countries according to the united nations ( ) can be classified into three categories: developed economies, economies in transition, and developing economies. geographical regions for developing economies are as follows: africa, east asia, south asia, western asia, and latin america and the caribbean. according to the o' sullivan and sheffrin ( , p. ) , a developing country is a country with a relatively low standard of living, undeveloped industrial base, and moderate to low human development index. this index is a comparative measure of poverty, literacy, education, life expectancy, and other factors for countries worldwide. for the sake of the discussion, the book will consider the classification of countries based on per capita gross national income (i.e., low-and middle-income countries (lmics)). the political, economic, and pharmaceutical sector conditions differ between the countries; some have to do much more and work harder to improve their situations than others. there are significant social and economic differences between developed countries and lmics. many of the underlying causes of these differences are rooted in the long history of the development of such nations and include social, cultural, and economic variables; historical, political, and geographical factors; as well as international relations. furthermore, it is not the intention of the book to indicate the level of the inferiority of an lmic or an undeveloped country compared with a developed country or between east and west, but rather to trigger and stimulate the mind of the people in the lmics about the challenges and problems the societies are facing for decades. no country in this world is free from problems and challenges, but people in the developing world suffer relatively more. the focus of this book is to highlight, discuss, and document policy issues in lmics and about having best practices in the pharmaceutical sector. so far, to what extent is the contribution of pharmacists to this matter? health and public health are essentials for development. around % of the world's population are residing in lmics and they are still living in poverty with poor health status and inadequate healthcare. in any healthcare system, pharmacy system is one of the core components and pharmacists play a very important role. with the dynamic changes happening in healthcare, disease, information communication technology and regulations, and the roles and responsibilities of pharmacists are becoming more important than before. the expectations on the pharmacists are changing; the societal needs and demands are much greater compared with several decades ago. on the other hand, there are growing problems with medicines, the health system, and human resources, especially in the lmics. there are countries with high prices of medicines, a wide prevalence of nonquality medicines (i.e., substandard and counterfeit), lack of access to medicines, and absence of a national medicines policy (nmp) even with strong encouragement from world health organization (who). poor health and pharmaceutical sectors in a country will increase the vulnerability of the country toward several critical problems at micro-and macrolevels and leaves the society at risk. in the medicines supply system, to ensure access to medicines, the following aspects are critical: • reliable health and supply systems; • sustainable financing; • rational selection; and • affordable prices of medicines. the importance of a healthcare system must be looked from three angles: the institutions, organizations, and resources; resources include workforce, financial, and infrastructure. to achieve universal health coverage, the system must function well. the three elements, i.e., institutions, organizations, and resources must be brought together to deliver quality health services to meet the demands of the society. unfortunately, according to mills ( ) , the goals of universal health coverage in lmics could not be achieved, child and maternal deaths are still high, financial protection is lacking, and people do not seek care because of lack of financial support. even though the rational use and quality use of medicines are worldwide issues, but they are particularly pertinent to lmics. access to medicines is still crucial, as children suffering from tuberculosis worldwide die daily, largely because of low access to appropriate treatment (who, a (who, , b . ranganathan and gazarian ( ) reported that there are several key challenges for delivering rational use of medicines (rum) to children in the developing countries. among the problems are as follows: • lack of coordinated nmp to support rum; • availability, affordability, and accessibility to medicines' issues; • inappropriate standards of quality, safe, and efficacy of medicines; • lack of independent, unbiased, and evidence-based information; • lack of information, knowledge, and skills among healthcare practitioners who are dealing with medication use process among children; • lack of proper devices and tools (e.g., calculator and weighing machine) used when deciding on the appropriate dosage for the children; and • retailers selling prescription medicines extensively over the counter. dowse ( ) reported that the likelihood of poor health literacy in developing countries is prevalent. health literacy is fundamental to the effectiveness of health programs and improvement to the quality of life. the united nations educational, scientific and cultural organization institute for statistics found that around % of countries ( / ) indicate an adult literacy rate below %. all these countries are from sub-saharan africa, and the lowest adult literacy rate is in mali with a . % (united nations, ). another issue is corruption. corruption (e.g., misinformation, bribery, theft, and bureaucratic corruption) is a global problem and negatively affects the medicines supply chain and the overall healthcare system. the backbone of the health system is formed by well-functioning supply chains that deliver various pharmaceutical products (yadav, ) . the corruption perception index illustrated that none of the lmics listed top of the transparent (i.e., clean) ranking. on the scale of (highly corrupt) to (very clean), over two-thirds of the countries and territories in this index fall below the midpoint (transparency international, ). people also faced with issues related to substandard medicines, counterfeit drugs, nutrition, tobacco consumption, maternal and child health, and environmental hazards (who, ) . who ( ) reported that the environmental hazards such air pollution caused around million premature deaths a year. most areas affected were densely populated lmics. the conditions in the developing countries become worse when people suffer from various turmoil conditions such as war, humanitarian conflict, and public health crisis, which further collapse completely the healthcare system. these aspects make working in the healthcare system and the practice of pharmacists more challenging. in short, the lmics are facing social, economic, environmental, human capital, political, and infrastructure issues that directly or indirectly affecting the health and pharmaceutical health services. much needs to be done in lmics. the following are important elements for functioning global supply systems and availability of safe and effective medical products at prices equitable to all: effective and innovative health and medicines policies, coordinated approaches, international cooperation, and effective oversight. especially for the pharmacy regulators, policy makers, and practitioners, they must appreciate the complexity of the healthcare system and human life. what is considered fine or rational in one country and society might not be fine or considered irrational among other societies with different cultures, beliefs, and backgrounds. regulators, policy makers, and practitioners in countries of the developing world should evaluate thoroughly health-and pharmaceutical-related issues in their country and find solutions that are appropriate and relevant according to the environment. there are several significant initiatives to ensure health for all and rum in lmics that were advocated by organizations such as health action international asia pacific (haiap), people health movement (phm), third world network (twn), international network for rational use of drugs (inrud) and who, just to name a few. chowdhury ( ) noted that "since the nairobi conference on the rational use of drugs, for every two steps we have advanced we have gone one step backward. a progressive agenda for people-centred, rational and affordable healthcare continues to be undermined by powerful vested interests." we are getting closer and closer, but are not there yet. the phm's member developed the people's charter for health in . it was established after realizing that vision and goals of alma-ata declaration that was established in failed to ensure "health for all by the year ." phm felt that the health status of the lmics has not improved as aimed, but instead worsened further. health crisis happened everywhere, especially in the lmics. there are significant inequalities between and within countries. new threats to health are continually developing (phm, n.d.) . according to international monetary fund (imf) ( ), "the world is a healthier place today but major issues continue to confront humanity." the world has improved greatly with eliminating and controlling few of the communicable diseases such as smallpox and polio. quality and better medicines have been produced to improve the health conditions. people have better sanitation and accessible to clean water. even with the innovations and cost-effective interventions in healthcare, individuals continue to experience and suffer from health threats such as malaria, dengue, typhoid, chikungunya, severe acute respiratory syndrome, middle east respiratory syndrome-related coronavirus, ebola virus crisis. in addition, the prevalence of mental disorders and noncommunicable diseases continues to increase. chronic diseases such as cancer, cardiovascular diseases, and diabetes cause serious ill health and millions of premature death. it is reported that % of them are in lmics. all these threats and disorders negatively affect the public health system and infrastructure, cause disability, and ruin businesses, workforce, and productivity of the affected country (imf, ; who, ) . thanks to pharmaceutical industries, which have produced antibiotics to fight against infectious diseases. the practice of medicine has been transformed. but, unfortunately due to the irresponsible and irrational used of antibiotics by healthcare providers and public, it has resulted in an increase in resistance and caused a worldwide decline in antibiotic effectiveness. the primary healthcare sectors failed to play their roles in containing these threats. the primary healthcare providers failed to perform their responsibilities. pharmacists have a responsibility regarding antibiotic stewardship to help contain or reduce amount of unnecessary antibiotic use especially against viruses and in trivial diseases. we need cost-effective, affordable, and practical interventions. the use of health technology assessment tools becomes helpful at this point. where are the pharmacists when the nations are crippled by these threats? do the pharmaceutical policies fail to curb these problems? the lack of adequate, resilient public health surveillance systems, infrastructure to effectively deploy resources, and a health workforce to provide accessible, quality care where needed leaves us vulnerable to regional and global spread. despite the progress that has been made in the last two decades, more needs to be done to create enabling regulatory environments. understanding the social and cultural contexts that may contribute to these problems, plus effective solutions, is also crucial. health communication often receives less attention and fewer resources than medical, scientific, or policy areas. there is an urgent need for society to value and invest more in evidence-informed public health strategies. the multifactorial nature of broader global health issues poses an enormous challenge to all stakeholders (who, b). effective public health action depends on understanding the scale and nature of threats to health (who, ) . according to the ottawa patient charter, the public health community has a duty to make the invisible visible. they must measure and assess the burden of diseases, health status, and risk factors including the protection factors. the public health community must make the best use of data to promote health. public health interventions should be evaluated, using rigorous research methods, and the results disseminated. the public health community must ensure that evidence is used to give voice to those who would otherwise be unheard. research findings must be disseminated effectively to the different stakeholders in the health sectors, including public, policy makers, practitioners, and (social) media. findings at times are complex and this information should be delivered in ways that are comprehensible and in a timely manner (lomazzi, ) . effective public health interventions can save hundreds of millions of lives in lmics, as well as create broad social and economic benefits. according to frieden and henning ( ) , it is often assumed that public health interventions applied in developed countries are not appropriate in developing countries. main public health functions are similar regardless of a country's income level. many basic public health measures achieved decades ago in developed countries are urgently needed, highly appropriate, extremely cost-effective, and eminently attainable in lmics today. further according to frieden and henning ( ) , a progress of public health in developing countries is possible but will require sufficient funding and human resources; improved physical infrastructure and information systems; effective program implementation and regulatory capacity; and, most importantly, political will at the highest levels of government. most change is due to money. for instance, robotics, automation, and technicians are widely used to save money. in the hospital setting, unit dose, unit-of-use, etc. are done to save cost. similarly, medication therapy management is done to save money and that is why most other changes are accepted, provided if they are cost-effective. pharmacists are dedicated and in a strategic position to preserve and advance public health. their efforts enhance the quality of individual's lives by helping people to live as free as possible from disease, pain, and suffering (jandovitz & brygider, ) . with respect to their relationship with the public, pharmacists are often portrayed as an underused resource for health-and medicines-related advice and information. furthermore, the practice of pharmacy involves both pharmacist and public and can be conceptualized as a social process (harding & taylor, , p. ) . don't we need something about the efforts to locate new pharmacy roles, e.g., in relation to immunizations, patient advisor, educator and advocator for wellness, screening and prevention activities, birth control promotions, and other population health initiatives? pharmacists have an obligation to educate the public in lmics, for example, teaching poor rural women about birth control and safe sex especially if their partner has hiv, etc. the other one is to encourage immunizations. in certain places, some cult leader and religious groups discourage their followers not to be immunized and then we end up with local epidemics of preventable conditions such as polio. hence, understanding the concepts and principles behind social pharmacy disciplines is important and useful. there is a need to apply a socioecological model to public health issues that are impacting the health of the population. what is social pharmacy? social pharmacy is a discipline driven by social needs (fukushima, ) and more focus on the society at large. it is interdisciplinary subject, which helps to understand the interaction between drugs and society. experts have defined social pharmacy as a discipline concerned with the behavioral sciences relevant to the utilization of medicine by both consumers and healthcare professionals (wertheimer, ) . sørensen, mount, and christensen ( ) defined social pharmacy as studying "…the drug/medicine sector… from the social scientific and humanistic perspectives. topics relevant to social pharmacy consist of all the social factors that influence medicine use, such as medicine-and health-related beliefs, attitudes, rules, relationships, and processes." almarsdottir and granas ( ) also agree that social pharmacy is a discipline where there is use of the social sciences in pharmacy to add its usefulness to the society. it is also known as "pharmacy administration" or "social and administrative pharmacy." it has two components: the social sciences and the administrative sciences. the social sciences component includes demography, anthropology, psychology, social psychology, sociology, political sciences, and geography (mount, ) , while the administrative sciences component includes areas such as management, marketing, finance, economics, organizational behavior, law, policy, ethics, information technology, and statistics. social and administrative pharmacy is the integration and application of the social and administrative sciences disciplines in pharmacy, i.e., education and practice. social pharmacy scientists utilize both sciences to improve clinical practice, enhance the effectiveness of pharmaceutical regulations and policy, advocate political awareness, and promote improvements in pharmaceutical health services and healthcare delivery. social pharmacy applied a biopsychosocial or socioenvironmental method to understand health and illness conditions (claire, ) . many types of research use either the quantitative or qualitative or a mixed method approach, from simple to complex statistical methods and modeling in pharmacy practice to make changes and improvement in the healthcare system, quality of care, and patient's quality of life. in addition, there are many useful tools from the social and behavioral sciences literature that researchers could use, for example, in helping with patient-pharmacist communication and compliance enhancement efforts. according to wertheimer ( ) , "there are very few similarities in the education and practice of pharmacy around the world." many individuals have an ethnocentric, regiocentric, or geocentric approach in which they believe. for example, pharmacy colleges in a country might be reluctant to accept improvement in the curriculum. the pharmacy educators think that they are superior, and the curriculum developed and used, for example, in the last decades was excellent. in some cases, there is an imbalance of focus between the pharmaceutical sciences courses and the pharmacy practice and administration courses. they consider teaching more of the basic pharmaceutical sciences subjects to the undergraduate students or just offering pharmaceutical sciences-related research (i.e., lab-based research) at the msc and phd level is adequate to provide the pharmacy graduates knowledge and skill to practice. the regiocentric or geocentric phenomenon in pharmacy practice is quite common and could be observed in the middle east region, for example. further, political struggle and lack of leadership could hurt the dynamic and mission of the pharmacy profession. according to morgall and almarsdóttir ( ) , the pharmacy profession could lose its monopoly and become weak due to the internal conflicts. pharmacists need to advocate locally to upgrade the quality of pharmacy education away from massive amounts of chemistry to applied patient care science and practice and to upgrade the level of standards in each country to work with legislators to ban pharmacies not operated by qualified, licensed personnel. when wertheimer and smith ( ) published the first edition of their book in , social pharmacy or social and administrative pharmacy was a very new discipline and possibly not known in the lmics. the book includes topics such as the contribution of the social sciences; pharmacy, pharmacist, and the professions; the contribution of psychosocial aspects; the contribution of sociology; and behavioral aspects of drugs and medication use, ethics, pharmacist and public health and the future of pharmacists. in the united kingdom, according to harding and taylor ( ) , social pharmacy was introduced in the pharmacy curriculum of uk colleges sometime in the early . the mills commission report in recognized the importance to develop the behavioral and social sciences aspects in pharmacy (study commission on pharmacy, ) . but, actually, the social pharmacy components were first experienced in the united states in the s (wertheimer, ) . then later, the uk and european colleges of pharmacy introduced social pharmacy into their curriculum (claire, ) . it is doubtful if pharmacy colleges in the lmics have successfully introduced this discipline in their pharmacy curriculum. most of the times, the internal politics and a lack of understanding limit or even counteract the collaboration of clinical and social pharmacy, thus weakening both fields (almarsdottir & granas, ) . however, there are cases, to name a few, which had reported positive experience such as in malaysia. school of pharmaceutical sciences, universiti sains malaysia that was established in , first introduced a course "drugs in developing countries" (mohamed izham, awang, & abdul razak, ) in the early s. after a long struggle, the discipline was established in (school of pharmaceutical sciences, n.d.) . several important courses (e.g., drug and society, social and public health pharmacy, pharmaceutical management and marketing, and pharmacoeconomics) managed to be included in the pharmacy curriculum. these additions offer a perspective on the pharmacy that balances and complements the behavioral and natural/physical sciences component of the pharmacy curriculum (hassali et al., ) to produce well-rounded graduates. in addition, the department has also produced hundreds pieces of social and administrative pharmacy-related research generated from more than msc and phd students from around lmics. kostriba, alwarafi, and vlcek ( ) identified large differences in approach and scope of teaching social pharmacy courses as a field of study in the undergraduate pharmacy education worldwide. they also identified regional trends connected with the political, economic, and social aspects of particular regions. basak ( ) expressed concern with the recent changes in the indian pharmacy education. according to the author, in the introduction of the pharmd program (pharmacy council of india, n.d.), social pharmacy is the least developed discipline in the curriculum. it called for cooperation in an attempt to develop social pharmacy components in teaching and research in india. there is a drive to incorporate the social pharmacy topics in the yemeni pharmacy education even with all the challenges and limitations that the country is experiencing nowadays (alshakka, aldubhani, basaleem, hassali, & mohamed ibrahim, ) . in libya, according to abrika, hassali, and abduelkarem ( ) , the pharmacy practitioners were supportive with the ideas of inclusion of social pharmacy subjects in the curriculum because it will enhance the pharmacists' professional roles. in contrast, in the united states, zorek, lambert, and popovich ( ) noted that even though the basic and clinical sciences provide a critical scientific foundation for direct patient care, pharmacists are likely to flounder in the face of social and behavioral challenges without a practical mastery of the relevant principles of modern social and behavioral science. according to the authors, pharmacy education and practice must require greater mastery of social and behavioral science. in the united kingdom, the incorporation of social and behavioral sciences into the curricula of all schools of pharmacy, reflecting a broad recognition that pharmacy practice does not simply involve supplying medicines and advice to a passive public who take their medicines and follow expert advice without question (harding & taylor, , p. ). we know a great deal about pharmacy in the developed world but we know very little about pharmacy practice, education, and science in the lesser developed countries. that is unfortunate because if we in the developed countries understood what the major problems and impediments were in the lesser developed countries, we could be in a better situation to offer advice and aid. very little has been published in the main stream, international literature about the status of pharmacy in the lesser developed countries. it is possible that some more is published in local journals in local languages that may be of limited help to others outside of that country. there are other problems as well. one is that accurate and timely vital health statistics may not be available for any of many possible reasons, such as budget restrictions, and shame in reporting accurate and precise reports that are not flattering to that country's leaders in the healthcare area. this book sheds light on various topics that individually and in combination determine the status of pharmacy practice in individual countries. the nature of pharmacy characteristics in a country has a great deal to do with traditions and characteristics from colonial times, the wealth of the country, its political and economic systems, the level of capital available for investment, the extent of technical education among the population, the presence of a middle class and the size of an upper class, if there is one, and the extent of a culture of corruption. there is one other reason why we need this book. when resources are constrained, sometimes clever persons devise exceptional strategies and schemes that require minimal resources. we are never so good that we cannot learn from our less fortunate colleagues, nor should we be too proud to borrow ideas and systems from nonindustrialized countries. if one of us wanted to learn about some aspects of pharmacy practice, education, or research in jordan, for example, it would be a time-consuming, complicated task, extracting various parts of our goal from a large array of journals, textbooks, and websites, and often a doomed task since some of the references importance of social pharmacy education in libyan pharmacy schools: perspectives from pharmacy practitioners social pharmacy and clinical pharmacy-joining forces importance of incorporating social pharmacy education in yemeni pharmacy school's curriculum social pharmacy concept in pharmacy education social pharmacy-the current scenario the limitations of current health literacy measures for use in developing countries the history of pharmacy pharmacy practice in developing countries: achievements and challenges public health requirements for rapid progress in global health social pharmacy: its performance and promise social dimensions of pharmacy: the social context of pharmacy teaching social pharmacy: the uk experience. pharmacy education social pharmacy as a field of study: the needs and challenges in global pharmacy education pharmacists: unsung heroes. wliw (television station social pharmacy as a field of study in undergraduate pharmacy education global charter for the public's health-the public health system: role, functions, competencies and education requirements health care systems in low-and middle-income countries introducing social pharmacy courses to pharmacy students in malaysia no struggle, no strength: how pharmacists lost their monopoly contributions of the social sciences economics: principles in action people health movement (phm) rational use of medicines (rum) for children in the developing world: current status, key challenges and potential solutions the concept of social pharmacy corruption perceptions index world economic situation and prospects country classification world economic situation and prospects international comparisons social/behavioural pharmacy: the minnesota experience pharmacy practice: social and behavioral aspects ottawa charter for health promotion from burden to 'best buys': reducing the economic impact of non-communicable diseases in low-and middle-income countries public health, environmental and social determinants of health who essential medicines and health products global disease outbreaks world health organization (who) health product supply chains in developing countries: diagnosis of the root causes of underperformance and an agenda for reform the -year evolution of a social and behavioral pharmacy course will be missing, unavailable, obsolete, or in foreign languages. some citations may only be available through the interlibrary loan organization, requiring several weeks.one may realize immediately that having all or nearly all of the desired data and information in one, easy-to-use source makes data collection and subsequent analysis far easier, and the work may be performed in a fraction of the time required to search here and there. in addition, relying on a single source for primary data can be dangerous. governmental statistics offices often spin data-related reports to underreport communicable diseases so as not to discourage tourism or so as not to put a country behind its neighboring nations in its effectiveness in combating health problems, childhood immunizations, etc.this book incorporates multiple data sources and when outliers are discovered, which may be called to the attention of the reader. this book also provides knowledge and understanding about social and administrative aspects of pharmacy in healthcare in lmics. it also creates awareness among readers, providing ideas and possible solutions to these obstacles. it is hoped that the pharmacists and other stakeholders will be better equipped to tackle any problems and challenges facing them in practice.if i had one hour to save the world, i would spend the first fifty-five minutes defining the problem and the last five minutes solving it. the world bank. world bank country and lending groups. https://datahelpdesk.worldbank.org/knowledgebase/ articles/ -world-bank-country-and-lending-groups. key: cord- -f u hbt authors: ni, zhao; lebowitz, eli r.; zou, zhijie; wang, honghong; liu, huaping; shrestha, roman; zhang, qing; hu, jianwei; yang, shuying; xu, lei; wu, jianjun; altice, frederick l. title: response to the covid- outbreak in urban settings in china date: - - journal: res sq doi: . /rs. .rs- /v sha: doc_id: cord_uid: f u hbt the covid- outbreak in china was devastating, and spread throughout the country before being contained. stringent physical distancing recommendations and shelter-in-place were first introduced in the hardest-hit provinces, and by march, these recommendations were uniform throughout the country. in the presence of an evolving and deadly pandemic, we sought to investigate the impact of this pandemic on individual well-being and prevention practices among chinese urban residents. from march - , , , individuals were recruited from provinces with varying numbers of covid- casers using the social networking app wechat to complete a brief, anonymous, online survey. the analytical sample was restricted to , urban residents. standardized scales measured generalized anxiety disorder (gad), the primary outcome. multiple logistic regression was conducted to identify correlates of gad alongside assessment of community practices in response to the covid- pandemic. we found that during the covid- pandemic, recommended public health practices significantly (p < . ) increased, including wearing facial mask, practicing physical distancing, handwashing, decreased public spitting, and going outside in urban communities. overall, . % of participants met screening criteria for gad and . %, . %, and . % reported that their work, social life, and family life were interrupted by anxious feelings, respectively. independent correlates of having anxiety symptoms included being a healthcare provider (aor= . , p < . ), living in regions with a higher density of covid- cases (aor= . , p < . ), having completed college (aor= . , p = . ), meeting screening criteria for depression (aor= . , p < . ) and poorer perceived health status (aor= . , p < . ). covid- had a profound impact on the health of urban dwellers throughout china. not only did they markedly increase their self- and community-protective behaviors, but they also experienced high levels of anxiety associated with a heightened vulnerability like depression, having poor perceived health, and the potential of increased exposure to covid- such as living closer to the epicenter of the pandemic. the novel coronavirus disease (covid- ) pandemic rst rapidly spread throughout china, and by august th , , it had manifested in countries with , , con rmed cases and , deaths worldwide. in the absence of effective vaccines or treatments, public health authorities have relied upon sheltering in place (self-quarantine at home), physical distancing in public settings, hand washing and wearing facial masks to prevent further spread. , without fully understanding its transmission, risk of progression, and widespread death from covid- , panic and even hysteria were common. the world health organization made public the covid- outbreak in january , and observed that the outbreaks were more severe in urban settings with a higher density of people. consequently, chinese residents increasingly complied with recommended containment measures that are necessary under this time of crisis, but those measures could disrupt their work and social and family life. also, during the pandemic, many urban dwellers remained relatively segregated within their neighborhoods, and this negatively impacted their psychological well-being. , anxiety symptoms among urban dwellers dealing with a volatile covid- pandemic, however, has not been broadly examined since it does not affect everyone equally. over the past years, various settings have reacted to new infectious diseases epidemics like sars, mers, and ebola and, though none of these developed pandemic proportions, understanding factors that may undermine the health of the community are important for future public health disaster planning efforts. we, therefore, conducted a nationwide online survey of people in china to identify those factors associated with anxiety from covid- and focused only on urban dwellers here, since they experienced covid- differently than their nonurban counterparts. we conducted baseline, online survey with , participants living in china; two additional waves are underway. participants inclusion criteria included: ) ≥ years old; ) living in mainland china; ) able to read chinese; and ) had access to wechat (the largest social networking app in china). all recruited participants were asked to complete a baseline survey over ten days from march - , . a total of , individuals from provinces, with the varied impact of the covid- pandemic, completed the online survey. the analytical sample was restricted to , urban residents who completed the enrollment survey. in this paper, the time point of covid- outbreak refers to january rd , , when wuhan city was placed in quarantine. the study protocol was approved by the institutional review board of yale university and received ethical approval from wuhan university. in this study, we used a modi ed snowball recruitment strategy where participants (seeds) were recruited one each from representative provinces in china. eleven representative provinces were selected from mainland china based on two criteria: ) being in one of mainland china's six socialeconomic regions as classi ed by the national bureau of statistics of china: north (beijing, tianjin, heibei, shanxi, inner mongolia), northeast (liaoning, jilin, heilongjiang), east (shanghai, jiangsu, zhejiang, anhui, fujian, jiangxi, shandong), central south (henan, huibei, hunan, guangdong, guangxi, hainai), southwest (chongqing, sichuan, guizhou, yunnan, tibet), and northwest (shaanxi, gansu, qinghai, ningxia, xinjiang); and ) covid- severity as was categorized by china national health commission (diagnosed covid- cases≥ , ; , - , ; - ; ≤ ) based on the percentage of provinces in each stratum in march ( figure ). using these criteria, we selected the following representative provinces: beijing, inner mongolia, heilongjiang, shandong, henan, hubei, hunan, guizhou, shaanxi, gansu, and xinjiang. seeds were recruited using convenience sampling method. to address the impact of the covid- pandemic, the survey was developed, and pilot tested using methods that have been described elsewhere. in brief, standardized scales were used, and responses to covid- were created. after drafting candidate questions, ten experts in the eld took the survey and provided feedback to re ne the survey. the revised survey was then designed on questionnaire star (https://www.wjx.cn/), a professional platform for online surveys, and a web link, and a qr code was generated. we then pilot-tested the survey with individuals who accessed the survey from a weblink or qr code and sought feedback. using feedback, we nalized the electronic survey and applied the webbased sampling method to recruit participants after identifying the seed in each province. the selected seed participants completed the survey and then distributed a yer that contained recruitment information, quick response (qr) code, and a link to the online survey among their social network. the distribution of the yer occurred through wechat moments ("peng you quan" in chinese) or their wechat groups ("wei xin qun" in chinese). interested individuals who clicked on the link were directed to an eligibility screener. each eligible participant voluntarily completed an online consent form by acknowledging that they understood the purpose, risks, and bene ts of the study prior to completing the survey. on average, participants took minutes to complete the anonymous online survey. the questionnaire was available in both english and chinese languages and was translated and backtranslated to ensure culture meaning. sociodemographic characteristics included age, sex, educational level, income, health, employment, and marital status. income was strati ed based on the relationship to the national levels. traveling history in the past days included whether they had traveled after the covid- outbreak, and whether they were put in quarantine. living environment was based on with whom they lived, and the region where they lived, strati ed by the density of covid- cases, with hubei province being the highest. we also measured where participants accessed information pertaining to covid- and what measures that their communities had taken to control covid- . participants' self-perceived health status were measured by the question "how is your current health status?" with a response of "very good", "good", "fair", "poor", and "very poor". these answers were dichotomized into "good" ("very good" + "good"), and "not good" ("fair" + "poor" + "very poor"). in addition, we assessed the frequency of the following health-related behaviors, before and after the covid- outbreak, which included wearing face masks, practicing physical distancing, washing hands, spitting, and showering. the questions related to each construct are included in table . the primary outcome was the presence of anxiety symptoms severity, which was measured by the generalized anxiety disorder -item (gad- ) scale, which has good reliability, sensitivity, and speci city for measuring anxiety in chinese populations. generalized anxiety disorder (gad) cut-offs for mild, moderate, and severe symptoms including scores of - , - , and > , respectively. other screening for mental illness included assessment of obsessive-compulsive symptoms using the obsessive-compulsive inventory and depression using the patient health questionnaire- . all data analyses were performed using sas . (sas institute, cary, north carolina, united states). data were presented using frequencies and means. chi-square test was used to compare the behaviors of wearing face masks and practicing physical distancing before and after the covid- . student's t-test was used to examine differences in hand washing, spitting, going outside, and showering, before and after the outbreak. logistic regression was used to examine the association between potential explanatory variables and the presence of anxiety. anxiety was dichotomized for values > , which is associated with the presence of anxiety symptoms. any variable signi cant at p< . in bivariate analyses were then entered into the multivariate logistic regression model to determine the odds ratio and % con dence intervals for the nal model. an additional analysis (supplementary data) for moderate to severe anxiety symptoms (cut-off > ) was also conducted. most participants (table ) were female ( . %), in their s ( . ± . ), completed a college degree ( . %), and perceived themselves to be in good health status ( . %). nearly % of the participants have an annual income of greater than ¥ , ( times greater than the international poverty threshold; equivalent to , usd), and . % of the participants were healthcare providers. nearly all ( . %) participants were living with families and remained in one city during the days prior to the study. participants were from regions with different density of covid- cases, . % of them were from the epicenter -hubei province. nearly half of the participants were married ( . %). most participants reported that they didn't travel ( . %) after the covid- outbreak, and most communities ( . %) had taken strict measures to control covid- . overall, the top three commonly used preventative measures in chinese urban areas were: controlling the entry and exit of people by checking their body temperature, banning gatherings in the community, and cleaning and sanitizing communal spaces ( figure ). the number of participants who wore face masks and practiced physical distancing, and the frequency of hand washing increased signi cantly after the covid- outbreak (p< . ). the rate of spitting in public places and going outside of one's home decreased signi cantly (p< . ; table ). [ insert table here] . . correlates of having generalized anxiety disorder several independent correlates were associated with having mild, moderate, and severe anxiety symptoms, including poor perceived health status (aor= . , p< . ), being a healthcare provider (aor= . , p< . ), received a college degree or above (aor= . , p= . ), living in hubei (aor= . , p< . ), and meeting screening criteria for depression (aor= . , p< . ; table ). . correlates of moderate to severe generalized anxiety disorder as shown in table in the supplementary appendix, poor self-perceived health status (aor= . , p< . ), higher frequency of washing hands (aor= . , p= . ), living in hubei (aor= . , p< . ), and meeting screening criteria for depression (aor= . , p< . ) were independently associated with moderate and severe anxiety symptoms. the unprecedented covid- pandemic has raised signi cant public health concerns and has an extended impact on the psychological well-being of society, especially in urban areas most profoundly impacted by the disease. the covid- epidemic unleashed a rapid and cataclysmic response by society, in which we report the profound protective response to the covid- outbreak. in response to government guidance and clear messaging, frequency of hand washing and physical distancing practices increased, while venturing outside in crowded urban spaces or spitting in public places decreased. though public spitting is unlawful in some chinese cities like beijing, hangzhou, and tianjin, it remains legal and practiced elsewhere; but during covid- , such practices markedly reduced. on may , , the chinese government of shanxi province passed china's rst provincial law prohibiting spitting in public places, which aimed to change uncivilized behaviors and prevent the spread of infectious diseases. , unlike physical distancing and handwashing that were widely recommended by public health authorities' sources, public spitting messages were mostly from non-o cial online sources. another explanation for a decrease in this behavior is that people remained inside more and such public spitting opportunities were less. these ndings do not appear to be driven by social desirability response since other hygienic measures that were not suggested in governmental and public sources, like showering, were not impacted. anxiety levels were high in this large sample. surveys from multiple countries, including china, germany, italy, saudi arabia, and turkey have shown that the prevalence of anxiety increased signi cantly with the global escalation of the covid- pandemic. for example, prior to the covid- outbreak, the prevalence of anxiety among a national sample of , chinese urban dwellers was . %, and in a post-covid survey of , chinese citizens, the prevalence rose to . % using the same gad screening instrument. our study had a similar prevalence to the other, but we identi ed more factors that were correlated with gad. unlike the other survey that found younger age (< years) and time spent (> hours daily) focusing on covid- , our assessment of urban dwellers found that gad was correlated with being a healthcare worker, living in region more profoundly impacted by covid- , having poorer self-perceived health status, having a college education and having moderate to severe depression. findings from our urban study, combined with those from both urban and non-urban dwellers, underscores the importance of providing support to a large number of people impacted by a new and evolving epidemic. our ndings, however, provide important insights into how to focus such intervention efforts to provide trauma-informed care. for example, healthcare workers, which have been identi ed elsewhere to experience exceptional levels of stress, should be targeted for screening and intervention. additionally, those with lower self-perceived health should be targeted. many such individuals may potentially have co-morbid conditions that increase their likelihood of experiencing more severe covid- disease if they become infected. , this is especially true since they may perceive they are unable to access needed healthcare services since during the pandemic, only essential medical visits were allowed, leaving them without support to self-manage their medical conditions. while patients with depression may also experience anxiety symptoms, in our survey, these variables were not collinear, but suggests that such patients have a lower psychological reserve to deal with stress and experienced heightened anxiety symptoms. this nding is born out in our additional analysis that shows depression is highly correlated with moderate to severe anxiety symptoms. in the initial stage of responding to covid- , most healthcare facilities in the outbreak regions shuttered their doors to patients, except for those with urgent needs. consequently, care was transitioned to telehealth. one potential implication from this survey is that healthcare providers, when providing tele-health to patients with chronic diseases that may heighten risk for more severe consequences of covid- , and even those with depression, should screen such patients for gad and provide supportive counseling, which can effectively be done using tele-health. as pandemics evolve, unscienti c ideas may proliferate about how infections can be prevented, treated and cured. in the early stage of covid- , rumors of several effective treatments were touted to suppress covid- from unsubstantiated online sources, which in turn generated the public anxiety because everyone wanted the treatments, yet they were unavailable for purchase. providing accurate health information guided by science is therefore important to mitigate excess anxiety during the pandemic. unsubstantiated rumors have been found to provoke anxiety and exacerbate mental health before sars, avian u, and swine u epidemics. - in times of crisis, it is even more important to ensure information is accurate and scienti cally grounded to ensure that people feel safe. in the case of covid- , considerable uncertainty existed and in an evolving crisis, conspiracy theories and hyperbole abound which, in turn, perpetuates anxiety. health information, however, often comes from multiple sources, but should be derived from someone who is respected, has authority and trusted by society. during an infectious pandemic that requires physical distancing, mobile technology may be crucial as a conduit of accurate (and sometimes inaccurate) information. , such information is more powerful, however, when collaborative learning is used and people can teach each other as long as an expert is there to guide discussion. collaborative learning in communities, de ned as integrating meaningful community engagement with education, instruction, and re ection to promote the capacity of individuals to take collective actions to improve the quality of life, is a key method considered by many international and national bodies to prepare for, respond to, and recover from emergency situations. , mobile technology-based interventions (e.g., telemedicine) could easily be repurposed to promote community learning not only as a dissemination method of accurate information, but also to address anxiety, maintain social connectivity while physically distancing, mobilize resources, and support communitybased networks of people in need. for instance, a tele-health visit using video or telephone from local clinicians could screen, motivate and treat patients and families. even when stigma about mental illness is common, as it is in china, brief motivational enhancement techniques can be deployed as part of trauma-informed care that can be done routinely without making a diagnosis. building such interventions and messages in public forums and giving people an opportunity to discuss how the pandemic is affecting them can provide an open opportunity for assistance. this would be especially crucial in some regions of mainland china where it might be considered "abnormal" or a shameful to seek treatment for anxiety. such individual or public messaging to provide trauma-informed care to individuals with anxiety would minimally include examples to support self-regulation of stressors, prioritize healthy relationships, explain why health restrictions are being made that otherwise limit routine daily activities, visualize what to expect within reason of what is known, and reframe behaviors to account for people not being at their best during times of crisis. it is no surprise that urban dwellers living closest to the epicenter and with the high density of covid- cases (e.g., hubei) experienced the most anxiety, relative to those in less dense covid- cases. these individuals had the most uncertainty as they were impacted rst and had the least amount of accurate information. such individuals might have also perceived themselves at highest risk, which is similar to our nding that healthcare workers, also at substantial risk, experienced heightened anxiety symptoms. of note, healthcare workers had an increased association of experiencing mild anxiety symptoms, but not moderate or severe anxiety symptoms. one might expect that such individuals would have the most severe anxiety symptoms because they are at the highest risk for covid- combined with extreme workloads during a heightened crisis management scenario where personal protective equipment and testing were inadequate. one potential explanation is that healthcare workers self-manage life and death situations on a daily basis and have established functional coping mechanisms. alternatively, data from wuhan suggested that over half of healthcare workers accessed support services, which may have helped them better deal with anxiety-provoking stressors. last, the healthcare workers in this survey may not have been those providing the most direct patient care and therefore did not experience the highest levels of anxiety. though this large survey assessing responses and anxiety symptoms across a large number of regions of china had many important and new ndings, it is without limitations. first, convenience sampling using wechat does not make this a fully representative sample and restrict generalizability. second, though markedly higher levels of generalized anxiety disorders were reported relative to the general population before covid- , we could not infer that covid- was causative due to the cross-sectional nature of the survey. last, some factors that may have contributed to anxiety symptoms may not have been measured, like time spent online seeking covid-related information or various types of coping mechanism. future research should more comprehensively study the possible negative psychological consequences of various countermeasures to nd out the best solution. finally, this study compared anxiety levels from before the outbreak to march but did not assess changes in anxiety levels over the entire period of the pandemic. more research should be conducted to examine changes in mental health outcomes over the entire pandemic period. covid- has had a profound impact on china initially and continues to do so globally. in china, urban residents markedly changed their health behaviors in response to the evolving epidemic. these urban dwellers also experienced profound levels of anxiety, especially in settings closest most profoundly impacted by the epidemic and in those most vulnerable like healthcare workers and those with poor perceived health, including those with depression. much has been learned from prior epidemics to guide a trauma-informed response, but when physical distancing practices are imposed, innovations in reaching screening, motivating and treating such individuals at increased risk for anxiety are urgently needed. technology-based interventions like online collaborative learning environments and tele-health can be used to solve such obstacles to service delivery. such lessons can be useful as new settings become susceptible to covid- and as secondary outbreaks emerge before an effective vaccine is made widely available. * in bivariate logistic regression models, those variables whose p-value is less than . was included in the multiple logistic regression. ** variables that have been significant at . level in multiple logistic regression model. ‡ participants who divorced or lost spouse were categorized into the categorize of married. a health-related behavior after the covid- outbreak. b health-related behavior before the covid- outbreak. compliance with ethical standards this work was supported by grants from the national institute on drug abuse for career development (k da to rs and k da to fla). the authors have no con icts of interest to disclose. the study protocol was approved by the institutional review board of yale university and received ethical approval from wuhan university. all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the helsinki declaration and its later amendments or comparable ethical standards. electronic informed consent was obtained from all individual participants included in the study. figure in this study, we used a modi ed snowball recruitment strategy where participants (seeds) were recruited one each from representative provinces in china. eleven representative provinces were qinghai, ningxia, xinjiang); and ) covid- severity as was categorized by china national health commission (diagnosed covid- cases≥ , ; , - , ; - ; ≤ ) based on the percentage of provinces in each stratum in march note: the designations employed and the presentation of the material on this map do not imply the expression of any opinion whatsoever on the part of research square concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. this map has been provided by the authors. covid- dashboard by the center for systems science and engineering (csse) at johns hopkins university (jhu). available at covid- : prevention and control measures in community changes in contact patterns shape the dynamics of the covid- outbreak in china fear and the front line mental health and psychosocial considerations during the covid- outbreak urban residents in states hit hard by covid- most likely to see it as a threat to daily life the mental health consequences of covid- and physical distancing: the need for prevention and early intervention centers for disease control and prevention. outbreaks can be stressful national health commission of the people's republic of china. 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of psychological distress among italian people during the covid- pandemic: immediate psychological responses and associated factors the psychological impact of covid- pandemic on the general population of saudi arabia levels and predictors of anxiety, depression and health anxiety during covid- pandemic in turkish society: the importance of gender generalized anxiety disorder in urban china: prevalence, awareness, and disease burden addressing the covid- pandemic in populations with serious mental illness a pilot randomized controlled trial of a depression and disease management program delivered by phone immediate psychological responses and associated factors during the initial stage of the coronavirus disease (covid- ) epidemic among the general population in china this is a list of supplementary les associated with this preprint. click to download.supplementalappendix.docx key: cord- -wzracd t authors: lemley, trey; fenske, rachel finch title: health sciences librarians supporting health and nutrition education in a culinary medicine curriculum date: - - journal: journal of the medical library association : jmla doi: . /jmla. . sha: doc_id: cord_uid: wzracd t background: culinary medicine is an innovative approach to teaching health sciences students and other health professionals the basics of healthy eating, food preparation, and nutrition through applied instruction. it is hoped these professionals will, in turn, share their knowledge with patients. the university of south alabama mitchell cancer institute licensed the tulane university's goldring center for culinary medicine curriculum and began teaching medical, nursing, and other health sciences students as well as community members in . the authors describe a collaboration between librarians and health professionals to connect with underserved community members by teaching the basics of good nutrition and healthy meal preparation. case presentation: two health sciences librarians provided instruction to community members in the use of quality health information resources during various modules of the culinary medicine curriculum. demonstrations of the use of medlineplus and choosemyplate were conducted using topics from module content. evaluations were distributed after each module to evaluate the effectiveness of the library component, the results of which enabled librarians to subsequently increase their instruction time and implement ipad use for more engaging participation. conclusion: librarians were seen as invaluable partners in this innovative program and became an integral part of the curriculum. evaluation results helped librarians advocate for more instructional time. as a result of their involvement, librarians were given additional outreach opportunities to educate younger populations at risk of developing chronic health diseases. background: culinary medicine is an innovative approach to teaching health sciences students and other health professionals the basics of healthy eating, food preparation, and nutrition through applied instruction. it is hoped these professionals will, in turn, share their knowledge with patients. the university of south alabama mitchell cancer institute licensed the tulane university's goldring center for culinary medicine curriculum and began teaching medical, nursing, and other health sciences students as well as community members in . the authors describe a collaboration between librarians and health professionals to connect with underserved community members by teaching the basics of good nutrition and healthy meal preparation. case presentation: two health sciences librarians provided instruction to community members in the use of quality health information resources during various modules of the culinary medicine curriculum. demonstrations of the use of medlineplus and choosemyplate were conducted using topics from module content. evaluations were distributed after each module to evaluate the effectiveness of the library component, the results of which enabled librarians to subsequently increase their instruction time and implement ipad use for more engaging participation. conclusion: librarians were seen as invaluable partners in this innovative program and became an integral part of the curriculum. evaluation results helped librarians advocate for more instructional time. as a result of their involvement, librarians were given additional outreach opportunities to educate younger populations at risk of developing chronic health diseases. culinary medicine is a new approach to health education that is becoming popular in the curricula of medical, nursing, and other health sciences schools. its goal is to help health care providers empower their patients with the knowledge to combat and prevent chronic illnesses so that patients can make good decisions about their eating habits, food consumption, food selection, and food preparation. as defined by la puma, culinary medicine is "a new evidence-based field in medicine that blends the art of food and cooking with the help of medicine" [ ] . dieticians and other health care providers provide information on specific diet plans and give sound advice for patients; however, many providers do not have the training or understanding of how healthy meal selection and preparation can assist in the overall well-being of a patient. culinary medicine helps both patients and health care providers understand the mechanics of food and how the choice of food can help improve various health conditions. when patients are told to change their diets, they are not generally given explanations in detail of why certain foods are better than others from their physicians. culinary medicine attempts to provide an understanding not only of eating behaviors, but also how food "influences metabolism, immunity, pathophysiology and well-being" [ ] . empowering patients to take a more informed approach to what they eat and how they prepare food provides them with a better understanding of the role food plays in everyday see end of article for supplemental content. living. when healthy food consumption can be seen as a treatment method for reducing elements of disease such as high cholesterol, patients will begin to associate food as medicine [ ] . tulane university's goldring center for culinary medicine is the pioneer in the field of culinary medicine. the first of its kind, the goldring center is a medical school-based teaching initiative led by a physician and trained chef that addresses deficiencies in nutrition education competencies among newly trained physicians [ ] . the goldring center has developed a culinary medicine curriculum to teach nutrition and cooking skills to medical students. currently, more than fifty academic medical centers including medical schools, nursing schools, and residency programs use the goldring center's curriculum. to illustrate, medical students at the university of central florida who participate in the goldring center curriculum not only learn culinary skills, but also transfer this knowledge to provide practical solutions for their future patients. presented with patient case scenarios, medical students are "asked to determine how food choices 'can impact and help heal'" [ ] . in addition, the goldring center convenes yearly conferences to expand knowledge in this evolving curriculum, showcasing cooking skills, research forums, and panel discussions on the importance of healthy eating and good health [ ] . the primary goal of the curriculum is to educate participants in the preparation of nutritious, tasty, and affordable food. using the mediterranean diet as its basis, the curriculum includes topics on nutrition and health, kitchen sanitation and workflow, healthy food shopping, weight management, and metabolic risk factors [ ] . participants learn portion control, how to read food labels, and culinary behaviors, such as preparing and cooking breakfast or using beans and legumes as part of a nutritious diet [ , ] . according to birkhead et al., participants benefit from practical instruction in the kitchen or classroom on changing eating habits, thus setting the stage for collaborative patient/physician relationships as participants engage in healthy eating and enjoy good health [ ] . talking to patients about the practicality of preparing and choosing good food can help reduce chronic disease and create conversations in the exam room that help patients understand the importance of healthy eating and nutrition. since , the curriculum has been offered to over , community participants in new orleans. the university of south alabama (usa) mitchell cancer institute (mci) licensed the culinary medicine curriculum from tulane university's goldring center in . to fund the program, mci obtained a well-integrated screening and evaluation for women across the nation (wisewoman) grant from the centers for disease control and prevention via the alabama department of public health. the wisewoman program focuses on low income, uninsured, or underinsured women aged forty to sixty-five years [ ] . classes were taught collaboratively onsite at bishop state community college (bscc) in mobile, alabama. mci is an academic cancer treatment center and research enterprise. since its founding, mci has become an integral part of the health care community and a much-needed resource for the central gulf coast region, performing interdisciplinary cancer treatment, a wide variety of clinical trials, and both basic and translational research. in addition, mci makes community outreach a major priority given the health disparities that exist in the surrounding community. because of its mission, mci actively promotes activities aimed at cancer control and prevention. after licensing the goldring center curriculum, mci disseminated information about the program to potential stakeholders at usa and in the mobile area who, in turn, immediately saw its value and possible benefit to medically underserved women in the community. although the initiative at tulane was aimed at medical students, numerous groups in mobile expressed interest in collaborating, and the culinary medicine program expanded to be a joint effort among several stakeholders, including usa, bscc, and members of the mobile area community. under the auspices of usa, a program administrator and a registered dietitian from mci, two librarians from the charles m. baugh biomedical library, and faculty and students from the colleges of allied health, medicine, and nursing participated. librarians' involvement included providing instruction on locating current, reliable, and highquality information on nutrition and other jmla.mlanet.org components of a healthy lifestyle to help participants gain a better understanding of their health and dietary needs and enable them to make beneficial lifestyle changes. faculty members from the colleges of allied health, medicine, and nursing enlisted a small cohort of students to become immersed in the curriculum so that they could gain nutrition competencies while learning how to connect with their patients in a more effective way. learning how to do this by cooking was a novel way of integrating nutritional knowledge with everyday applications for meal planning and execution. bscc was the site location where classes were taught, because it had an established commercial food service program and a teaching kitchen that accommodated sixteen people. the director of the commercial food service program was a trained chef and graduate of the college of culinary arts at johnson and wales university. she and other commercial food service program faculty assumed key leadership roles and participated in every class. since the culinary medicine program was initiated, there have been numerous cohorts of participants, who have consisted of community members or usa health sciences students, depending on the decisions of program leaders. during the first year of our involvement, participants consisted of community members from the mobile area. in particular, franklin primary health center in mobile encouraged their patients to participate in the program. incentives to enroll, such as health progress monitoring over the course of a year and a one-time yearly gym membership, were provided. the culinary medicine curriculum comprised modules per cohort, with classes held once a week from : p.m.- : p.m. over a -week period. each module commenced with a discussion led by culinary medicine faculty about the instructional content covered in the module (figure ), followed by actual meal preparation ( figure ). all attendees then shared the meal, during which time the chef discussed the meal's nutritional content ( figure ). the module concluded with an interactive discussion on how the meal preparation could be incorporated into the participants' weekly meal rotation. the six modules include: one of the authors (lemley), a senior librarian, was a long-time member of mci's cancer control & prevention committee. in , committee members were invited to attend an introductory meeting to learn about the culinary medicine program, during which time it was decided to license the curriculum from the goldring center. in , the librarian asked mci program officers if they would allow librarians to participate by providing consumer health information to participants in the curriculum. mci enthusiastically embraced this idea and was very supportive. during that year, the librarian attended several planning sessions with major stakeholders. when onsite involvement began in , the lead author (lemley) invited the second author (fenske), the new outreach services librarian, to join the initiative as a way to expand her contacts in the community. this involvement proved to be very successful, as additional outreach activities were initiated by virtue of participation in this project. in all cohorts, library instruction sessions were based on teaching objectives for a particular module and were tailored to address the concepts introduced in the module. for example, when a module included materials on the mediterranean diet, we demonstrated how to find information on this diet using the health topics category in medlineplus, a consumer-friendly health database from the national library of medicine. in response to questions from participants, we demonstrated how to access the medlineplus medical encyclopedia to explain unfamiliar terminology. because module included materials on dietary fiber, we demonstrated how to easily obtain quality information on this topic by reading the "dietary fiber" entry in the medlineplus health topics section. finally, we introduced participants to choosemyplate, an online resource from the us department of agriculture. at the end of our presentation, we distributed informational packets with pamphlets and brochures about medlineplus and other relevant health resources for participants' use. jmla.mlanet.org ( ) october journal of the medical library association throughout the presentation, we emphasized that medlineplus and choosemyplate were free, easy to use, current, and of the highest quality, and are produced by major federal agencies. during the first year of our involvement, the time frame of the library session was very brief, no more than fifteen minutes. this was an extremely short time period to demonstrate the resources; however, we were able to introduce the resources and make participants aware of their ease of use and quality. with this limited time period, we did not have the opportunity to engage in hands-on activities to reinforce concepts that were introduced in the module. however, we appreciated the opportunity to participate in the program and, by doing so, were hopeful that participants would use these resources to find current and reliable consumer health information relevant to good nutrition and a healthy lifestyle. in , the first year of our involvement, we participated in cohorts (n= ), both consisting entirely of community members. after each presentation, we distributed a short evaluation survey (supplemental appendix) to participants. the purposes of this evaluation were to determine the possible value and benefit of the library component of the program and to gauge whether participants planned to apply the information to their specific health needs after the program. in addition, we wanted to justify the need for additional class time to integrate hands-on activities. our evaluation results suggested that most participants felt that the library component of the program was beneficial and that the information presented was new to them (table ). most participants agreed that medlineplus was a valuable, easy-to-use, consumer-friendly health resource that would empower them to apply the information for their specific health needs. although our instructional sessions were short (i.e., fifteen minutes), we were pleased to see that participants indicated that they would begin using the presented resources for their health information needs and would recommend the websites to their friends and family, thus promoting the use of quality health resources by a greater population. another beneficial discovery was that participants wanted more time to explore the health resources and indicated that a hands-on session would be helpful. although participants indicated the class time allotted for teaching was adequate, responses to two additional questions gauging participants' interest in having more time to learn the databases and participate in a hands-on activity provided evidence that our allotted time was not sufficient. with these data, we were able to justify more instruction time in future cohorts to program administrators. informal comments from program officials, faculty, and participants regarding our lectures and participation in numerous cohorts from to have been very positive. participants were excited to see librarians included in the curriculum and were given a new perspective on the work that health sciences librarians performed. based on the evaluation results and positive reinforcement from program officials, we participated in additional cohorts in and and were asked to continue our involvement with three additional cohorts in , all of which were cancelled due to the covid- pandemic. beginning with the cohort, library instruction sessions expanded to a thirtyminute segment and included a hands-on component using ipads. since implementing these changes in , we distributed another evaluation form and found that participants, consisting of both community members and health sciences students (n= ), liked having a hands-on component, and many wanted more time to learn about medlineplus (table ) . therefore, the use of evaluation tools to assess the library sessions was beneficial for justifying our changes to the curriculum. because of our positive impact in the curriculum, other avenues of instruction and outreach surfaced for the outreach librarian. she was invited to teach instructional sessions on medlineplus and other national institutes of health resources to undergraduate nutrition students at bscc and taught a high school dietetics class about health issues and concerns that were prevalent in the community. jmla.mlanet.org the adoption of the culinary medicine program at usa's mci created a unique opportunity for health sciences librarians to become full partners in this multidisciplinary approach to healthy eating. we were seen as valuable allies in curriculum development and integral members of the program. using evaluation tools to collect data validated our involvement and was vital in helping us successfully advocate for more time in the classroom, thereby providing an enhanced instructional experience. our involvement in the program demonstrated an effective method of building alliances with health professionals and community members to provide resources for nutrition education, promotion of healthy eating habits, and prevention of chronic diseases. other librarians in health sciences could also use this approach to increase exposure to the services they provide while building healthier communities. this collaboration has also enabled the outreach librarian to expand into other community engagement activities that have benefited the younger generation, who are themselves at risk of developing chronic health issues. while heart disease is the leading cause of death in mobile county, community assessment data also indicate that diabetes is on the rise locally [ ] . with our community confronting these health issues, having the opportunity to provide information on healthy eating habits and nutrition to college and high school students has been extremely beneficial. most importantly, this collaboration helped community members learn the importance of healthy eating and meal preparation. when community members have access to current and reliable information that can be easily understood, they become better informed, which can lead to more engaging conversations with their health care providers. thus, patient education has huge potential for improving the quality of care and resulting in better health outcomes [ ] . the emergence of culinary medicine programs has addressed the inadequacies of nutrition education in the curricula of medical, nursing, and health sciences schools, where content focuses more on traditional science-based disciplines such as anatomy than food-related knowledge and skills [ , , , , ] . additionally, with the rise in obesity and other chronic diseases, the impetus to improve preventive medicine among health professionals and their competency in clinical nutrition becomes imperative [ ] . the goldring center has led the way to significant changes in the medical school curriculum and has proved to be critical in medical students' competency in providing nutrition education and nutrition counseling to their patients [ ] . the culinary medicine initiative has broadened to include nursing, allied health, and other health sciences departments, which in turn have partnered with culinary schools, chefs, and dieticians to give health sciences students the knowledge to prepare and cook tasty food while learning about its nutritional value. this, in turn, has provided them with the skills to communicate with their patients the importance of healthy eating choices that prevent and treat diseases that are diet related [ ] . our opportunity to partner with the mci culinary medicine program has enabled us to bring awareness of quality consumer health resources that can be used to enhance these patient provider conversations. in addition, the exposure to these resources has planted the seed for continued use by community members for their health information needs. health sciences librarians have always supported the research needs of health sciences students and the professional community, but in our case, these constituencies saw how easy-tounderstand consumer health resources could be incorporated into their patient consultations. culinary medicine provides students with the skills to counsel patients in preventive health behaviors that enhance a patient's self-care and well-being. with our contribution, they have learned about new tools to assist in this endeavor [ ] . our demonstration of how to locate recipes using medlineplus to community members brought the use of reputable library resources into the kitchen, and the medical student instructor in the first cohort saw the ease with which they could be used for counseling patients. thus, the handson approach to dietary counseling and education was enriched by our involvement. with the implementation of culinary medicine, physicians, nurses, and other health care providers can help patients make sound medical decisions about their eating habits in a way that they understand best: through the foods they eat [ , ] . providers can begin conversations with patients on a practical level and be more confident in the information that they provide. patients can learn how to eat healthier and be more participatory in their well-being, and librarians can be seen as a positive force in culinary medicine education by providing essential information for all. we hope that other culinary medicine collaborations will enlist the participation of health sciences librarians to further enhance the overall effectiveness of this exciting development in health education and patient empowerment. funding for the wisewoman program (https://www.cdc.gov/wisewoman/) was made available through the centers for disease control and prevention. what is culinary medicine and what does it do? popul health manag medical student-led community cooking classes: a novel preventive medicine model that's easy to swallow innovative med schools put future doctors in the kitchen health meets food: the culinary medicine curriculum health-related culinary education: a summary of representative emerging programs for health professionals and patients. glob adv health med the centers - community health needs assessment improving health outcomes through patient education and partnerships with patients nutrition education: strategies for improving nutrition and healthy eating in individuals and communities nutrition education in an era of global obesity and diabetes: thinking outside the box information services librarian, and head of reference and collection development assistant librarian and information services/outreach librarian, charles m key: cord- - wvly f authors: low, daniel m; rumker, laurie; talkar, tanya; torous, john; cecchi, guillermo; ghosh, satrajit s title: natural language processing reveals vulnerable mental health support groups and heightened health anxiety on reddit during covid- : observational study date: - - journal: j med internet res doi: . / sha: doc_id: cord_uid: wvly f background: the covid- pandemic is impacting mental health, but it is not clear how people with different types of mental health problems were differentially impacted as the initial wave of cases hit. objective: the aim of this study is to leverage natural language processing (nlp) with the goal of characterizing changes in of the world’s largest mental health support groups (eg, r/schizophrenia, r/suicidewatch, r/depression) found on the website reddit, along with non–mental health groups (eg, r/personalfinance, r/conspiracy) during the initial stage of the pandemic. methods: we created and released the reddit mental health dataset including posts from , unique users from to . using regression, we analyzed trends from text-derived features such as sentiment analysis, personal pronouns, and semantic categories. using supervised machine learning, we classified posts into their respective support groups and interpreted important features to understand how different problems manifest in language. we applied unsupervised methods such as topic modeling and unsupervised clustering to uncover concerns throughout reddit before and during the pandemic. results: we found that the r/healthanxiety forum showed spikes in posts about covid- early on in january, approximately months before other support groups started posting about the pandemic. there were many features that significantly increased during covid- for specific groups including the categories “economic stress,” “isolation,” and “home,” while others such as “motion” significantly decreased. we found that support groups related to attention-deficit/hyperactivity disorder, eating disorders, and anxiety showed the most negative semantic change during the pandemic out of all mental health groups. health anxiety emerged as a general theme across reddit through independent supervised and unsupervised machine learning analyses. for instance, we provide evidence that the concerns of a diverse set of individuals are converging in this unique moment of history; we discovered that the more users posted about covid- , the more linguistically similar (less distant) the mental health support groups became to r/healthanxiety (ρ=– . , p<. ). using unsupervised clustering, we found the suicidality and loneliness clusters more than doubled in the number of posts during the pandemic. specifically, the support groups for borderline personality disorder and posttraumatic stress disorder became significantly associated with the suicidality cluster. furthermore, clusters surrounding self-harm and entertainment emerged. conclusions: by using a broad set of nlp techniques and analyzing a baseline of prepandemic posts, we uncovered patterns of how specific mental health problems manifest in language, identified at-risk users, and revealed the distribution of concerns across reddit, which could help provide better resources to its millions of users. we then demonstrated that textual analysis is sensitive to uncover mental health complaints as they appear in real time, identifying vulnerable groups and alarming themes during covid- , and thus may have utility during the ongoing pandemic and other world-changing events such as elections and protests. unemploy, economy, rent, mortgage, evict, enough money, more money, pay the bills, owe, debt, make ends meet, afford, save enough, salary, wage, income, job, eviction table s : manually constructed lexicons. developed to assess the prevalence of tokens related to these topics in all of the subreddits. the dictionary created as described in section . was applied to all posts to create a bag-of-words corpus which was used to create an lda model using passes and workers. models with , , , , and topics were created. models were also generated multiple times with different subsamples of posts to assess stability of topics. a manually chosen lda model with topics was then applied to all posts across all subreddits (mental health and non-mental health) to assess the distribution of topics, allowing for comparison between the distribution of posts prepandemic vs midpandemic. a manually chosen lda model created on midpandemic data was applied to posts from r/covid _support to assess any change in topic distribution. since umap contains parameters that could affect relative distance between subreddits as could downsampling the data to obtain balanced classes, we estimated the precision of this approach on data. first, hyperparameter tuning was performed ( samples for each subreddit) to find the parameter set that optimized clustering measured through silhouette score using n neighbors ( , , , , , ) , min dist ( . , . , . , . , . , . ) and metric (euclidean, cosine). second, to tackle the variance caused by subsampling, we measured the pairwise hausdorff distances between clusters across runs, each with new random subsampling. using a distance metric between clusters, rather than their absolute centroid location, allows for avoiding rotation or flipping effects of dimensions. bootstrapping across runs provides an estimate of the method's precision and also allows us to measure how rare changes in distances are with respect to a distribution of regular fluctuations for a non-pandemic year ( ). for , we also compute the median distance across bootstrapping samples for our final analysis. see figure s for examples of trends and regression. see figure s for main results and figures s and s for comparisons to and trends. see table in the main text for examples of significant trends in figure s . figure s for more details. table s . cluster annotations. cluster annotations were assigned based on a review of the features found to distinguish each cluster, using wilcoxon rank-sum tests with bonferroni correction. representative significantly cluster-associated features informing the annotation are shown, along with the total number of significant features per cluster. clustering was performed separately with k= on the prepandemic posts dataset from and the midpandemic posts dataset from . the majority of clusters were approximately replicated between the two time periods. each pair of clusters (one from the prepandemic data and one from the midpandemic data) assigned the same annotation are shown side-by-side to illustrate the overlap of their predictive features. a few clusters were detected only in the prepandemic dataset (e.g., general mental health, seeking advice) and a few were only detected in the midpandemic dataset (e.g., self harm, entertainment). two "resources" clusters were detected in the prepandemic dataset, and three were detected in the midpandemic dataset. the characteristic features were not meaningfully distinct for any among these "resources" clusters and these clusters partitioned an island of posts visible in umap space, so all "resources" clusters detected in a given dataset were collapsed into a single cluster. columns are marked with stars for subreddits on which posts from the given cluster were significantly enriched. see figure b for the full set of cluster enrichments on the analysed subreddits. we analyzed whether the subreddits that most increased in their health anxiety topic correlated with the ones that most increased in negative semantic change as measured by the trend analysis, but this was not significant (ρ = - . , p = . ). . this highlights that the distributions of these particular topics within a single subreddit largely did not change between pre and midpandemic timeframes, except for an increase in the topics "health anxiety" and "life" and a decrease in the "alcohol/addiction" topic. figure s : prepandemic lda model over non-mental health subreddits. distribution of prepandemic lda topics for posts in non-mental health subreddits prepandemic (left) and midpandemic (right). as with the mental health subreddits, distributions of these particular topics within a single subreddit largely did not change between pre a parsimonious rule-based model for sentiment analysis of social media text operator's manual and midpandemic timeframes, except for an increase in the topics "health anxiety" and "life" and a decrease in the "alcohol/addiction" topic. figure s . pairwise changes in distance between subreddits throughout pandemic. total pairwise distance between subreddits for each time window displaying only extreme values with regards to normal fluctuations (top and bottom th percentiles), which indicates they are less likely to be part of regular fluctuations in distance (see supplement . for a precision analysis of this approach). key: cord- -ajlmyjoe authors: ullrich, sarah; cheung, maija; namugga, martha; sion, melanie; ozgediz, doruk; yoo, peter title: navigating the covid- pandemic: lessons from global surgery date: - - journal: ann surg doi: . /sla. sha: doc_id: cord_uid: ajlmyjoe nan development of open source ventilators, and reprocessing n masksusing the hydrogen peroxide vapor sterilization technique. [ ] [ ] [ ] [ ] in many lmic, healthcare supply chains arevulnerable at baseline, and providers are regularly faced with shortages of supplies and ppe.items that are considered disposable in hic, such as et tubes and electrocautery tips and pads, are often reused after high level disinfection. equipment shortages in lmic have led to the expanded use of regional anesthesia with iv sedation, and most surgeries are performed open rather than via laparoscopy.operating room supplies are opened only as-needed and evaluated after each case; only the most essential available instruments for every case are opened, and key instruments are prioritized for sterilization throughout the day. similar strategies towards the pragmatic use of operating room resources could be considered in hic and may even decrease perioperative costs. public private partnerships and innovative local production strategies have emerged in lmic in response to widespread oxygen shortages. , such strategies may be considered in hic should there be an oxygen shortage during the covid- pandemic. additionally, surgical gowns, head covers, and surgical drapes in lmic are cloth, requiring washing and reuse,whereas such supplies are disposable in the majority of hospitals in hic, particularly in the us. the use of disposable surgical textiles is largely driven by reimbursements to hospitals based on volume of purchases, and there is a lack of evidence to suggest that the use of disposables have an overall cost or safety benefit. transitioning to increased use of reusable products where possible would make hic hospitals less vulnerable to supply chain disruptions and would additionally have a substantial sustainability benefit. amid the covid- pandemic, the number of patients requiringmechanical ventilation in the us could range between . and patients per available ventilator, which would necessitate thoughtful resource allocation should hic face a ventilator shortage. even outside the setting of pandemics, lmicface a constant shortage of ventilators and icu care, even in national referral hospitals. as a result, many young patients die from reversible etiologies, such assurgical disease, postsurgical complications, infectious diseases, trauma, and peripartum maternal or neonatal complications. providers in these settings routinely make difficult ethical and practical decisions about theallocation of icu care,often informed by the local context and cultural factors. this extends through the entirety of the perioperative journey, from who can be offered copyright © wolters kluwer health, inc. unauthorized reproduction of this article is prohibited. surgery, to operative approaches and post-operative care.scoring systemsappropriate for the lmic context have been developed, andtake into account some of these factors. , other mitigation strategies include the development of high-dependency units,which have increased capacity for monitoring and oxygen delivery, and training programs for the limited numbers of ward nurses emphasizing early recognition and intervention for critically ill patients. should ventilator shortages become apparent, a planning exercise for this type of scenario in hic may be worthwhile given the current reality of ventilator shortages to potential need. . a large volume of critically-ill patients combined with potentially high rates of healthcare worker infections and exposures hasled to staffing shortages in both hic and lmic during covid- . lmic already face severe staffing shortages due to a variety of factors, including low numbers of graduates, poor salaries and working conditions as well as high attrition rates. addressing such shortages has required a number of innovations, some of which could potentially be adapted for use in hic. a program to engagefamily members in multiple aspects of patient care has been used successfully by narayana health in india. family members were trained to perform tasks such as monitoring fluid balance, taking and recording vital signs and assisting with incentive spirometry, which not only cut costs and addressed staffing shortages, but reduced post-operative complication rates. due to social distancing guidelines and visitor restrictions in hospitals this may be most effectively utilized for post-hospitalization care and rehabilitation programs as support staff and rehab centers are also part of the overwhelmed healthcare community. in lmic, both physician and non-physician general practitioners are commonly called upon to perform essential surgery. such task sharing, where healthcare workers are reorganized and required to work in alternative roles in order to meet changes in workforce demands, is a common solution to staffing shortages in lmic. during the covid- pandemic, this practice been a necessary adaptation in hic as the imminent need for many specialties declined, whereas intensivists and generalists have been in high demand. in our own hic institutions we have seen the re-allocation of surgical critical care physicians and surgeons into roles assisting in the medical intensive care units and medical floors helping care for both covid and non-covid medical patients. this crisis has brought attention to the need to address the shortage of more broadly trained personnel and generalist physicians, which is largely attributed to the high costs copyright © wolters kluwer health, inc. unauthorized reproduction of this article is prohibited. of medical school and procedure-based reimbursement strategies, resulting in higher salaries for specialist physicians. going forward, the expansion of policies to incentivize young doctors to enter general practice, such as tuition reimbursement and a transition to value-based payment strategies in both hic and lmic may be necessary. the widespread, immediate implications of the acute shortages during the covid- pandemic have highlighted the need for systems strengthening in both hic and lmic and haveforced us to re-examine our approach to healthcare delivery.telemedicine is being optimized globally more than ever before to prevent surges through forward triage, minimize healthcare worker exposures and address workforce shortages. the widespread implementation of telehealth interventions can be leveraged long after the pandemic ends to overcome challenges of distance and patient access in both hicand lmic.this will need to be done thoughtfully to ensure that alternatives are developed when necessary for vulnerable populations that may have challenges in technology use.disruption in the global supply chain for healthcare supplies has underscored the importance of building redundancies into the system, and has led to the opening up of new local supply chains by linking local stakeholders. shortages of ppe and other essential equipment have also highlighted the need for a transparent, centrally controlledstrategic reserve of medical supplies. hospitals have had to rapidly scale up icu capacity, which has underlined the value of redundant capacities and flexibility within the healthcare system. these lessonshave highlighted the need for long-term investment to build flexible, resilient health systems and are sure to help providers in both hic and lmic care for more patients safely and effectively both during this pandemic and long after it ends. learning how lmic providers manage resource limitations through global surgery collaborations can give surgeons working in hic valuable perspective that has become increasingly relevant during the covid- pandemic. the rapid expansion of social media has facilitated such collaborations, and is a valuable tool for networking, mentorship and information sharing. additionally, the rapid sharing of research findings via social media is enhancing our ability as a global health community to respond to this pandemic in a strong evidence based manner. however, it is essential that social media be used responsibly, and precautions are taken to prevent the spread of misinformation. copyright © wolters kluwer health, inc. unauthorized reproduction of this article is prohibited. for surgeons working in hic, there is much to learn from counterparts in lmic. healthcare systems in many lmic, particularly in africa, have more experience responding to infectious disease pandemics, especially in contact tracing and community mobilization.the extensive network of community health workers in lmic is an essential component of grass roots public health infrastructure that hic may be able to emulate. triage systems, finite resources, and limited personnel in lmic require constant thoughtfulness regarding testing, treatment, and disposition. more importantly, working in a resource-variable environment requires fostering a set of soft skills that lmic practitioners utilize on a daily basis. these include adaptability, resourcefulness, frugality of supplies, humility, and leadership among others.these lessons highlight the importance of fostering bilateral partnershipsand increasing relevance of global health competencies to surgical training. examples such as task sharing illustrate that hic can adapt and can respond to these challenges with resilience. this requires vigilant monitoring of the situation and constant improvisation in the face of unpredictable challenges. these and other nontechnical skills are always essential to ensure safe and high quality surgical care but become especially pertinent during this trying time. the most vulnerable populations, often linked to the underlying social determinants of health such as poverty, food security, literacy, gender, and racial and ethnic factors, are most at risk of adverse outcomes during these health and social shocks. there is already data demonstrating that racial and ethnic minorities in the us and uk are at increased risk of death from covid- . difficulty in accessing care for emergent conditions exists at baseline for these populations, and extensive backlogs for essential operations are commonplace, especially in lmic. this is likely only to get worse during the current crisis and underscores the importance of our professional commitment to health equity -regardless of geography.new estimates of the "collateral damage" caused by the pandemic are very concerning and also illustrate the urgent need to mitigate this impact through local and global coordinated action. the overall lack of collective and individual health equity around the globe dramatically weakens our global heath security and without addressing this disparity, the even the best attempts by hic to ensure safeguard domestic health will always be undermined. the grave reality is in both lmic and now in hic, population needs vastly outpace our resources, and it is the patients who are affected unless we too improvise, adapt and innovate. global surgery collaborations with reciprocity between copyright © wolters kluwer health, inc. unauthorized reproduction of this article is prohibited. partners,with trainees and faculty working together, enhance our capacity to share our collective expertise and navigate this pandemic resiliently. best care at lower cost: the path to continuously learning health care in america critical supply shortages -the need for ventilators and personal protective equipment during the covid- pandemic global surgery : evidence and solutions for achieving health, welfare, and economic development global surgery : evidence and solutions for achieving health, welfare, and economic development intensive care unit capacity in low-income countries: a systematic review variation in critical care services across north america and western europe scarcity of protective items against hiv and other bloodborne infections in low-and middle-income countries making your own reusable elastomeric respirator for use during covid- viral pandemic n shortage hydrogen peroxide vapor sterilization of n respirators for reuse wolters kluwer health, 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forward in resource-limited settings workforce innovations to expand the capacity for surgical services wolters kluwer health, inc. unauthorized reproduction of this article is prohibited india on post-operative health perceptions and outcomes of cardiothoracic surgical patients surgical task-sharing to non-specialist physicians in low-resource settings globally: a systematic review of the literature the united states health care system is sick: from adam smith to overspecialization virtually perfect? telemedicine for covid- opening up new supply chains community health and equity of outcomes: the partners in health experience contextual challenges to safe surgery in a resource-limited setting: a multicenter, multiprofessional qualitative study sharpening the global focus on ethnicity and race in the time of covid- early estimates of the indirect effects of the covid- pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study. the lancet global health global health security: the wider lessons from the west african ebola virus disease epidemic wolters kluwer health, inc. unauthorized reproduction of this article is prohibited key: cord- -e fhlo authors: semaan, aline; audet, constance; huysmans, elise; afolabi, bosede; assarag, bouchra; banke-thomas, aduragbemi; blencowe, hannah; caluwaerts, séverine; campbell, oona maeve renee; cavallaro, francesca l; chavane, leonardo; day, louise tina; delamou, alexandre; delvaux, therese; graham, wendy jane; gon, giorgia; kascak, peter; matsui, mitsuaki; moxon, sarah; nakimuli, annettee; pembe, andrea; radovich, emma; van den akker, thomas; benova, lenka title: voices from the frontline: findings from a thematic analysis of a rapid online global survey of maternal and newborn health professionals facing the covid- pandemic date: - - journal: bmj glob health doi: . /bmjgh- - sha: doc_id: cord_uid: e fhlo introduction: the covid- pandemic has substantially impacted maternity care provision worldwide. studies based on modelling estimated large indirect effects of the pandemic on services and health outcomes. the objective of this study was to prospectively document experiences of frontline maternal and newborn healthcare providers. methods: we conducted a global, cross-sectional study of maternal and newborn health professionals via an online survey disseminated through professional networks and social media in languages. information was collected between march and april on respondents’ background, preparedness for and response to covid- and their experience during the pandemic. an optional module sought information on adaptations to care processes. descriptive statistics and qualitative thematic analysis were used to analyse responses, disaggregating by low-income and middle-income countries (lmics) and high-income countries (hics). results: we analysed responses from maternal and newborn health professionals. only one-third received training on covid- from their health facility and nearly all searched for information themselves. half of respondents in lmics received updated guidelines for care provision compared with % in hics. overall, % of participants in lmics and % in hics felt mostly or completely knowledgeable in how to care for covid- maternity patients. facility-level responses to covid- (signage, screening, testing and isolation rooms) were more common in hics than lmics. globally, % of respondents reported somewhat or substantially higher levels of stress. there was a widespread perception of reduced use of routine maternity care services, and of modification in care processes, some of which were not evidence-based practices. conclusions: substantial knowledge gaps exist in guidance on management of maternity cases with or without covid- . formal information-sharing channels for providers must be established and mental health support provided. surveys of maternity care providers can help track the situation, capture innovations and support rapid development of effective responses. introduction the covid- pandemic has substantially impacted maternity care provision worldwide. studies based on modelling estimated large indirect effects of the pandemic on services and health outcomes. the objective of this study was to prospectively document experiences of frontline maternal and newborn healthcare providers. methods we conducted a global, cross-sectional study of maternal and newborn health professionals via an online survey disseminated through professional networks and social media in languages. information was collected between march and april on respondents' background, preparedness for and response to covid- and their experience during the pandemic. an optional module sought information on adaptations to care processes. descriptive statistics and qualitative thematic analysis were used to analyse responses, disaggregating by low-income and middleincome countries (lmics) and high-income countries (hics). results we analysed responses from maternal and newborn health professionals. only one-third received training on covid- from their health facility and nearly all searched for information themselves. half of respondents in lmics received updated guidelines for care provision compared with % in hics. overall, % of participants in lmics and % in hics felt mostly or completely knowledgeable in how to care for covid- maternity patients. facility-level responses to covid- (signage, screening, testing and isolation rooms) were more common in hics than lmics. globally, % of respondents reported somewhat or substantially higher levels of stress. there was a widespread perception of reduced use of routine maternity care services, and of modification in care processes, some of which were not evidence-based practices. coronavirus disease (covid- ) has affected . million cases as of may and caused more than deaths globally, with an estimated case fatality rate of . %. this highly infectious disease is transmitted through close contact with what is already known? ► in addition to lack of healthcare worker protection, staffing shortages, heightened risk of nosocomial transmission and decreased healthcare use described in previous infectious disease outbreaks, maternal and newborn care during the covid- pandemic has also been affected by large-scale lockdowns/curfews. ► the two studies assessing the indirect effects of covid- on maternal and child health have used models to estimate mortality impacts. ► experiences of frontline health professionals providing maternal and newborn care during the covid- pandemic have not been empirically documented to date. infected persons or via contaminated surfaces. vertical transmission (antenatally or intrapartum) remains a possible concern, and covid- effects during the first and second trimesters of pregnancy are unclear. breastfeeding continues to be encouraged with appropriate hygiene measures, including wearing face masks. the limited available evidence suggests that pregnant women do not face higher risks of infection and disease severity. [ ] [ ] [ ] a meta-analysis of pregnant women with covid- showed higher risk of preterm birth, pre-eclampsia and caesarean section. symptoms among newborns seem to be mild, though one study reported a higher perinatal death risk. more data and larger sample sizes must be collected to draw definitive conclusions. it is prudent to protect pregnant women from covid- through both individual-level and population-level measures, considering the increased risk of infection with other respiratory viruses such as influenza, and the increased mortality linked with h n . however, recommendations to avoid infection remain similar for pregnant women and the general public. some countries, such as the uk, categorised pregnant women as a vulnerable group and issued stricter measures for them. the pandemic's indirect effects will likely surpass the direct infection effects on women and newborns. previous outbreaks severely reduced health systems' capacity to provide essential maternal and newborn health (mnh) care, with negative impacts on health outcomes. [ ] [ ] [ ] ebola virus disease (evd), severe acute respiratory syndrome and middle east respiratory syndrome (mers) outbreaks highlighted challenges in countries' preparedness to face outbreaks, amplified by weak existing systems. these include lack of protection of healthcare workers leading to disruptions in staffing, heightened risk of nosocomial transmission and elevated stress among service providers. other indirect consequences of outbreaks include limited capacity for public health surveillance and lower use of healthcare. [ ] [ ] [ ] during the covid- pandemic, large disruptions to healthcare provision and utilisation also stem from unprecedented largescale measures implemented by countries (eg, lockdowns, curfews and transport restrictions). indirect influences of previous outbreaks persisted long after their containment, but much of the evidence available about mnh is modelled or uses secondary data such as population-based surveys and routine health information systems that are originally collected for purposes other than studying the effect of the outbreak on mnh and fail to prospectively document these impacts over time. to date, studies assessing potential indirect effects of the covid- pandemic on sexual, reproductive, maternal and child health in low-income and middleincome countries (lmics) have used modelling approaches. roberton and colleagues modelled three scenarios projecting a decrease in the coverage of basic life-saving interventions. they estimated an increase in maternal deaths between and , and - additional deaths of children under years. similar conclusions were drawn by riley et al, who projected that a modest decline in the use of sexual and reproductive healthcare services in lmics will result, over a year, in million additional women with unmet need for modern contraceptives, million additional unwanted pregnancies and over million additional unsafe abortions. it is therefore critical that the precise nature of both direct and indirect impacts of covid- , and the adaptations and innovations tested to reduce its impact are prospectively captured and described. health professionals' views and experiences when providing care to women and newborns during this pandemic have not been empirically documented to date, and there is a necessity for prospectively assessing the effects of the covid- pandemic on mnh services. the objective of this paper is to synthesise key themes identified in the first round of a global online survey of health professionals working in mnh along four dimensions: preparedness for covid- , response to covid- , personal experience in the workplace and changes in care provision and processes. this online survey is part of a larger study seeking to: ( ) understand how health professionals and health facilities prepare and respond to covid- in regard to the care provided to women and their babies; and ( ) document and analyse the effect of the covid- pandemic on the services available to pregnant, labouring and what are the new findings? ► respondents in high-income countries more commonly reported available/updated guidelines, access to covid- testing and dedicated isolation rooms for confirmed/suspected covid- maternity patients. ► levels of stress increased among health professionals globally, including due to changed working hours, difficulties in reaching health facilities and staff shortages. ► healthcare providers are worried about the impact of rapidly changing care practices on health outcomes: reduced access to antenatal care, fewer outpatient visits, shorter length of stay in facilities after birth, banning birth companions, separating newborns from covid- positive mothers and postponing routine immunisations. what do the new findings imply? ► covid- illustrates the susceptibility of maternity care services to emergencies, including by reversing hard-won gains in healthcare utilisation and use of evidence-based practices. ► maternity care differs from other services, inasmuch as healthy women are being brought into health facilities that are operating suboptimally, and potentially increasing risk of infection, from covid- and other healthcare-associated infections. ► these rapid findings can inform countries of the main issues emerging and help develop effective responses, but similar efforts are needed to understand women's experiences. postpartum women and their newborns, including as a result of increasing pressures on the healthcare system. this is a cross-sectional study of health professionals providing mnh care services. the target population was health professionals directly providing maternal (antenatal, intrapartum and/or postnatal) or newborn care, including midwives, nurses, obstetricians/gynaecologists, neonatologists, paediatricians, anaesthetists, general practitioners, medical officers, clinical officers, community health workers, lactation counsellors, paramedics, health technicians and health professionals in training. due to the unavailability of a global sampling frame for this study population, sampling was non-random and not intended to generate generalisable nationally representative results of either health professionals or facilities. rather, our intention was to collect and synthesise the voices and experiences of mnh professionals from various countries, contexts, services and facility types at the early stage of the covid- pandemic. an invitation to complete the survey was distributed using personal networks of the multicountry research team members, maternal/newborn platforms and social media (eg, facebook, twitter and whatsapp). respondents were encouraged to share the survey with other colleagues in an attempt to snowball the sample population. respondents provided informed consent online by checking a box affirming that they voluntarily agreed to participate in the survey. a questionnaire was developed in english by an international team of collaborators including health professionals, experts in health systems, infectious diseases, infection prevention and control, maternal health epidemiologists and public health researchers from various global settings. it was piloted by asking five mnh professionals from different settings to complete the questionnaire and provide feedback, which was used to assess face validity and refine the wording of questions and response options. the final version was translated into languages that were made available consecutively (french and arabic were available at launch; italian, portuguese, spanish, japanese, german and dutch were available within days; chinese, russian and kiswahili were added after weeks). we collected data on respondents' background, preparedness for covid- , response to covid- and own work experience during the pandemic. all respondents were invited to participate in an optional module that asked about adaptations to care processes and respondents' perceptions regarding changes in the uptake of care by women and newborns. the questionnaire is provided in online supplementary file . we use responses collected between march and april . we cleaned received responses by removing duplicate submissions (n= ), refusals to participate (n= ) and submissions made by those not directly providing maternal or newborn care (eg, lecturers and public health officials; n= ). quantitative analysis involved descriptive statistics (frequencies and percentages) using stata/se v. . responses were stratified by country income levels according to world bank classification. we conducted a qualitative thematic analysis of free-text answers to derive common themes of respondents' experiences and changes in the work environment and care process by country income levels. when possible, we triangulated qualitative and quantitative results to validate emerging themes. from the remaining responses, we dropped from the analysis responses with missing answers on more than % of questions. the extent of missingness to closeended questions ranged from . % to . % and that to open-ended questions from % to % of respondents. missing answers to the 'country' question were recoded based on the 'region' answer for responses; for example, a respondent with a missing response for country but region reported as maharashtra was coded as from india. the sample included mnh care professionals, % of whom participated in the questionnaires' optional module (n= ). participants worked in countries and % were from high-income countries (hics; table ). online supplementary file includes a map showing respondents' geographic distribution and the total number of confirmed cases as of the midpoint of our data collection period ( april ). most were obstetricians/gynaecologists or midwives ( % and %, respectively), and around % worked in public sector facilities. nearly half of respondents from hics ( %) reported that their facilities had seen covid- confirmed or suspected maternity patients, compared with % of respondents from lmics. most respondents ( %) received information on covid- , including on transmission, treatment, prevention, screening and updated policies, and only one-third attended trainings/drills on the response to covid- (table ) . several perceived that trainings would make them 'feel better prepared' to respond to women's needs during the outbreak. half of lmic-based respondents received updated guidelines reflecting measures for the outbreak when providing mnh care, compared with % of those from hics (table ) . this was a source of concern for some bmj global health respondents from tanzania, rwanda, uganda and india, as remarked by an obstetrician/gynaecologist from uganda: 'i am worried that no national guidelines [are] rolled out yet regarding care for pregnant women and newborns'. some midwives in hics requested clearer guidelines on home-based midwifery care. nearly all respondents searched personally for information on covid- ( %) and received informal guidance from colleagues ( %, table ). some lmic-based participants worried about lack of access to/availability of evidence on covid- effects during pregnancy and possible transmission to fetus and/or newborn. only % of participants perceived that they were completely knowledgeable of providing care to covid- maternity patients (table ) . personal experiences facilities adopted several measures in response to covid- . most hic-based respondents noted that their low-income and middle-income countries ( ) ( ) high-income countries ( ) ( ) region east asia and pacific ( ) ( ) europe and central asia ( ) ( ) latin america and caribbean ( ) ( ) middle east and north africa ( ) ( ) north america ( ) ( ) south asia ( ) ( ) sub-saharan africa ( ) ( ) cadre midwife ( ) ( ) nurse-midwife ( ) ( ) nurse ( ) ( ) obstetrician/gynaecologist ( ) ( ) neonatologist general practitioner ( ) ( ) medical doctor (no specialisation) ( ) ( ) medical student/intern/resident ( ) ( ) community health worker/outreach worker ( ) ( ) other ( ) ( ) position head of facility ( ) ( ) head of department or ward ( ) ( ) head of team ( ) ( ) team member ( ) ( ) locum or interim member ( ) ( ) other † ( ) ( ) type of care provided (multiple responses allowed) outpatient anc ( ) ( ) home-based childbirth care ( ) ( ) ( ) private for profit ( ) ( ) non-governmental ( ) ( ) faith-based or mission ( ) ( ) other ( ) ( ) type of area large city (more than million inhabitants) ( ) ( ) small city ( to million inhabitants) ( ) ( ) town (fewer than inhabitants) ( ) bmj global health care (anc) outpatients and inpatients were screened either in person or over the phone before appointments/admission. the ability to test maternity patients for covid- was limited in lmics ( %), rural areas ( % in lmics; % in hics) and completely unavailable in refugee and/or displaced persons camps (n= , data not shown). healthcare workers reported various concerns regarding care provision during the outbreak. respondents perceived the lack of covid- symptom screening and testing as threats to staff and patient safety. a midwife from canada wrote, 'i'm worried about being infected by someone who is asymptomatic, and then being a vector to others'. personal protective equipment (ppe) deficiencies also compromised patients' and healthcare providers' safety across all settings but more prominently in lmics ( most respondents noted that covid- affected their work ( %) and that their stress levels were higher than usual ( % , table ). an obstetrician from mozambique described, 'my stress level is immeasurable. every time a pregnant woman with flu-like symptoms [visits the health facility], i feel almost completely lost. i need to be equally protected and i don't feel any protection from whoever [is responsible of protecting me]'. challenges included shortage of qualified staff, either because of symptoms, self-isolation after potential exposure, or inability to reach their workplace, as a midwife in uganda described: '[t]ransport to work is a big challenge due to lockdown; many staff live far away from the hospital. staff who manage to come to work hurry to leave early to observe the curfew time of . p.m.'. this shortage led to an increase in workload and frequent changes in schedules. certain healthcare facilities increasingly relied on locum workers and students to fill staffing shortages. some respondents requested more support from management as exhaustion increased. a department head in uganda reported, '[t] here are no more clear work schedules as i get to attend many unscheduled/emergency meetings. staff are very anxious and panicky and need talking to all the time, which is exhausting'. some participants from lmics such as india, bangladesh, bolivia and syria expressed concerns regarding 'patients and relatives not following instructions given by staff members', such as social/physical distancing and hygiene. a nurse from syria attributed this to a 'lack of awareness and knowledge, and indifference among beneficiaries'. changes to care provided to women and newborns bmj global health they are sick'. most respondents noted shorter visiting hours and fewer allowed visitors, while others reported screening visitors for symptoms or banning visits altogether. the number of labour companions was limited to one person (also allowed to accompany the mother after birth), or none at all. an obstetrician from the czech republic remarked that: '[the] gynaecological and obstetrical society recommended to ban partners and doulas from accompanying a woman at birth -outrageous!!!'. among the reported changes, some facilities implemented social/physical distancing in waiting areas and in hospital rooms by reducing the number of beds. however, this was difficult to achieve in small facilities; an obstetrician/gynaecologist from india noted: '[it is] not practically possible [to place each patient in a separate birthing room] in our set up'. non-essential services including elective gynaecological procedures and infertility treatments were postponed or cancelled. several facilities restricted routine anc to the management of high-risk patients. a respondent from new york reported a 'significant decrease in number of anc visits', whereby new policies recommended reducing face-to-face visits during pregnancy 'from to [visits] , to four [visits]'. other changes include eliminating waiting areas, spacing appointments to reduce contact between patients and cancelling group activities such as health education sessions. the pandemic entailed adaptations to care process and content, subsequently affecting quality. anc and postnatal care (pnc) provision and breastfeeding counselling shifted to telemedicine. participants in lmics acknowledged that women's inadequate access to communication infrastructure prevents equitable healthcare provision. respondents were concerned over uncertain impacts of reduced contacts on the quality of care. a midwife from the uk wrote: '[w]hilst i completely see the need to restrict face-to-face care to protect staff and patients, my heart just breaks for women and families who we won't be able to offer the full range of midwifery support to… that is, breastfeeding support, daily visits, and just generally our time'. across all settings, the demand for home births increased and new practices aimed to reduce labour inductions. in certain hics, induction of labour was discouraged before weeks of gestation, using nitrous oxide for pain relief diminished to reduce risk of transmission through aerosols, and waterbirths were suspended. caesarean sections were commonly performed among women diagnosed with covid- and some facilities dedicated theatres specifically for this purpose. elective caesarean sections decreased among 'healthy' maternity patients. however, some facilities aimed to reduce labour duration and time spent in the labour room by augmentation. respondents speculated about a potential rise in caesarean section rates in their facilities, as noted by an obstetrician/gynaecologist from india: 'we will not allow as much time in second stage [of labour], this is likely to push up our caesarean rate'. respondents frequently mentioned shortened length of stay in facilities after childbirth; for example, a reduction 'to - from or more [hours]' (midwife from canada). a midwife from the uk wrote, '[the] lack of time and staff will lead to mothers and babies going home with very little feeding support or knowledge which will have a short and long term impact on their health and ability to deal with infections'. routine postnatal checks were postponed or substituted with telemedicine in some cases as reported by a nursemidwife from the usa, '[w]e are postponing the routine postpartum visit until weeks postpartum, and are prescribing most contraceptives over the phone and breastfeeding support is all done virtually'. changes to newborn pnc were infrequent and included monitoring and isolating babies of mothers with covid- . three respondents from india noted that vaccination schedules were disrupted or postponed. mnh professionals feared that changes in standards of care would lead to poor health outcomes among women and newborns and subsequently to the loss of achieved progress. 'i am worried about the implications of policies that call for separating newborns from covid- positive mothers immediately after birth, without allowing for skin-toskin or delayed cord clamping', wrote a nurse-midwife from the usa. this paper uses a rapid collection of data from health professionals providing care to women and newborns globally during initial stages of the covid- pandemic. we describe preparedness for covid- , response to covid- , personal experience in the workplace and changes in care provision and processes. healthcare providers commonly resort to personal searches and informal networks to fulfil information needs. accessing unreliable information related to covid- is likely, particularly on social media. facility-specific creation and distribution of guidelines for managing maternity patients is somewhat lagging behind despite frequent updates by ministries of health and professional associations. [ ] [ ] [ ] [ ] [ ] [ ] [ ] information sharing channels must be established to secure providers' timely access to accurate information. [ ] [ ] [ ] midwives supporting pregnant and labouring women during the pandemic, particularly independent practitioners, need clear guidelines for providing home-based care. response sharp discrepancies in facility-level responses to covid- between hics and lmics could stem from the differential progression of the outbreak (online supplementary file ) or be partly attributed to limited health system capacities and resources in some countries. an attenuated outbreak is speculated in africa, yet it is equally possible that trends similar to those witnessed in europe will occur. this indicates an urgent need to mobilise resources, improve testing capacities and upgrade responses, with the needs and complexities of mnh care provision in mind. absence of testing in refugee and/or displaced persons camps raises concerns. overcrowding and inadequate water and sanitation in underserved settlements are barriers to basic infection prevention measures. [ ] [ ] [ ] [ ] displaced women's and newborns' access to mnh services is suboptimal, and they experienced poor outcomes before the pandemicinduced disruptions of essential care. [ ] [ ] [ ] [ ] efforts should ensure that displaced populations are protected, with adequate access to testing, treatment and quality mnh care to halt anticipated exacerbations of negative health outcomes. personal experiences mnh care workers during the pandemic experience increased stress and anxiety, consistently with experiences from previous outbreaks. stress levels in lmics were comparable with those in hics, although countries were battling different outbreak stages (online supplementary file ). this might be due to uniformly reported shortages in skilled workforce leading to higher workloads and staff burnout. wilson et al suggest measures to prevent burnout among maternity care providers along prioritising adequate emotional, social and mental health support, including from managers. as our findings show, this adds burdens to management staff, a group that deserves special focus during this outbreak. reliance on students increases their vulnerability to stressors considering their lack of experience, and senior colleagues should actively advocate for their well-being. future research should explore the availability and effectiveness of mental and social support to mnh care providers during the pandemic. insufficient ppe intensifies the fear of nosocomial transmission. in some facilities, ppe supplies are prioritised for departments treating covid- cases and do not reach maternity wards. mnh care workers and patients could experience uneven risks of nosocomial infection during outbreaks. in some countries, obstetricians/ gynaecologists commonly work in multiple facilities, and their risk of exposure might be exacerbated by the higher number of contacts they experience in this dual practice. although ppe are essential, their rational use is recommended by the who given universal shortage. these guidelines must be clearly communicated to mnh care providers and patients. health workers caring for women around the time of birth might be used to wearing some ppe; yet, it can make them feel dehumanised, and the donning and doffing of ppe might delay emergency service provision. changes in care provision and processes care practices are rapidly changing and their consequences on health outcomes are uncertain. our findings support narratives told by healthcare providers, and align with disruptions witnessed during previous outbreaks, [ ] [ ] [ ] which have increased maternal and neonatal mortality. currently, there are signs of similar trends in two maternity hospitals in uganda. our knowledge of the impact of these changes is restricted to predictions resulting from modelling, which strongly suggest a threat to achieved improvements in lmics. the actual impact is yet to be quantified, and the effect in hics remains unclear. prioritising measures depending on contextual needs can mitigate the pandemic's indirect consequences. previous outbreaks of infectious diseases such as evd in west africa and mers in south korea have imposed barriers to healthcare access and utilisation, including fear of nosocomial transmission, healthcare facilities' closure and loss of trust in the healthcare workforce. our findings show that in the case of covid- , fear of disease spread was perceived to reduce healthcare use, and unprecedented societal measures such as lockdowns, curfews and transport restrictions emerge as new challenges to healthcare provision and utilisation. although some changes to care content and process matched updated guidelines other modifications diverge from available evidence. these include eliminating birth companions, banning visitors, performing caesarean section on all covid- positive women, augmenting labour or performing unindicated caesarean sections to control timing of deliveries, separating newborns from covid- positive mothers, not allowing breast feeding and reducing length of stay with fewer home-based follow-ups. such practices deny women's access to quality care and jeopardise their wellbeing and that of their babies. unlike curative services, maternity care provides holistic support to women going through a normal physiological process; both overintervention and underintervention can result in a massive preventable burden. additionally, and although only reported in india in our survey, alarming disruptions or delays in routine immunisation are also implemented in other lmics. during evd outbreak, vaccination activities were similarly disrupted for safety purposes, leading to substantial declines in immunisation coverage. catch-up campaigns should be prioritised following the relaxation of preventive measures. introducing new models of care such as telehealth guidance was described as a 'virtually perfect solution' to continuing care provision. however, this model is not compatible with all healthcare services and providers dread its impact on care quality. patient and community resistance to outbreak control measures and mutual incomprehension between patients and providers could shape the impact of covid- on mnh care. health-seeking behaviours rely on provider-patient relationships and common cultural, economic and social understanding of health and hygiene. [ ] [ ] [ ] [ ] hierarchical issues may affect mnh care quality as shown in west african urban areas and malagasy hospitals. understanding social and cultural responses to epidemics is essential to mitigate disasters and avoid a top-down management of outbreak guidelines that may miss the mark of preexisting factors. the lack of representativeness and related sample bias are limitations of this sampling approach. our sample might over-represent higher qualified cadres of health professionals in settings with limited use of technology among lower cadres of staff, and under-represent overstretched staff, or those with limited or no access to internet connection, as we received few responses from professionals working in lower level facilities, particularly in lmics. some cadres were less represented (eg, neonatologists and paediatricians). the sample's representativeness is affected by the availability of the survey in three languages (english, french and arabic) for a longer time than the remaining nine languages. the questionnaire asks about facilities where respondents work, which is not relevant to independently practising professionals, especially midwives; this might have discouraged some of them from completing the survey. finally, data were collected across countries going through different stages of the outbreak; in some countries, responding to such surveys is discouraged or forbidden by authorities (eg, china). this is the first study describing the preparedness for, response to, and effect of the covid- pandemic on mnh care provision. the multicountry survey creates an innovative platform for lessons to be documented and shared. our findings, ideally combined with an understanding of women's perspectives, hold enormous potential for establishing a timely, evidence-based decision-making platform. continued collection, rapid synthesis and timely dissemination of health workers' voices to planners, programmers and policymakers is crucial to guide the development and implementation of contextually relevant guidance. the covid- pandemic illustrates a susceptibility to emergencies, which is not restricted to healthcare systems in lmics. this crisis is challenging health systems and providers and disrupting access to basic services worldwide. health system preparedness might have been equally inadequate in lmics and hics in some aspects, such as shortage in skilled staff, training provision and ppe sufficiency. however, it is likely that hics were able to respond more effectively due to better health system resilience such as existing coordination systems to develop and implement changes to protocols. findings from this study will be useful in supporting the development of effective responses to main identified issues, during various stages of the covid- pandemic and more broadly during future health system shocks. coronavirus disease (covid- ) situation report- characteristics of and important lessons from the coronavirus disease 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expert group from the field of medical anthropology what is a resilient health system? lessons from ebola acknowledgements we would like to thank the study participants who took time to respond to this survey despite the difficult circumstances and increased workload. we acknowledge the institutional review committee at the institute of tropical medicine for providing helpful suggestions on this study protocol and for the expedited review of this study. we would like to thank all study collaborators and colleagues who distributed the invitation for this survey and provided suggestions on the questionnaire, including the coauthors of this paper, dr susannah woodd and dr jean-paul dossou. we are immensely grateful to all those who volunteered to translate the survey, including contributors lb conceptualised the study and obtained funding. all authors contributed to the design of the study and development of the survey tool. as analysed the data. ca, lb, eh and as wrote the original draft of the manuscript. all authors contributed to the development of the manuscript and read and approved the final version. the corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. as is the guarantor. key: cord- -vt qovf authors: ogojiaku, chinonso n.; allen, jc; anson-dwamena, rexford; barnett, kierra s.; adetona, olorunfemi; im, wansoo; hood, darryl b. title: the health opportunity index: understanding the input to disparate health outcomes in vulnerable and high-risk census tracts date: - - journal: int j environ res public health doi: . /ijerph sha: doc_id: cord_uid: vt qovf the health opportunity index (hoi) is a multivariate tool that can be more efficiently used to identify and understand the interplay of complex social determinants of health (sdh) at the census tract level that influences the ability to achieve optimal health. the derivation of the hoi utilizes the data-reduction technique of principal component analysis to determine the impact of sdh on optimal health at lower census geographies. in the midst of persistent health disparities and the present covid- pandemic, we demonstrate the potential utility of using -input variables to derive a composite metric of health (hoi) score as a means to assist in the identification of the most vulnerable communities during the current pandemic. using gis mapping technology, health opportunity indices were layered by counties in ohio to highlight differences by census tract. collectively we demonstrate that our hoi framework, principal component analysis and convergence analysis methodology coalesce to provide results supporting the utility of this framework in the three largest counties in ohio: franklin (columbus), cuyahoga (cleveland), and hamilton (cincinnati). the results in this study identified census tracts that were also synonymous with communities that were at risk for disparate covid- related health outcomes. in this regard, convergence analyses facilitated identification of census tracts where different disparate health outcomes co-exist at the worst levels. our results suggest that effective use of the hoi composite score and subcomponent scores to identify specific sdh can guide mitigation/intervention practices, thus creating the potential for better targeting of mitigation and intervention strategies for vulnerable communities, such as during the current pandemic. of health, functioning, and quality-of-life outcomes and risks [ ] . a shift in focus in the field of public health has caused additional attention to be paid to sdh. understanding the impact these determinants have on a community's health is a vital part of achieving health equity [ ] . researchers estimate that approximately % of health can be attributed to social and economic factors and % are due to factors related to the physical environment [ ] . these sdh vary both between and within communities based on variety of demographic characteristics. examples of sdh include access to healthcare services, neighborhood crime and violence levels, and food security and availability. due to the current coronavirus disease (covid- ) pandemic, the united states is currently experiencing a higher number in cases and deaths than what we are seeing globally [ ] . the asymptomatic nature of the disease combined with pattern of transmission of covid- , emphasizes the importance of community health. within the u.s., there are existing disparities of underlying health conditions that influences the way the pandemic is impacting marginalized groups and communities. the disparities in covid- related health outcomes can be linked to a number of factors. african american communities and other communities of color in new york for example, are experiencing higher rates of infection and death during the covid- pandemic than their white counterparts within the city [ ] . various factors within these communities render them to being more vulnerable to disease. for example, residents are struggling to access healthcare resources in their neighborhoods, while multigenerational homes put older residents' home at risk. in addition, communities that have higher perveances of heart disease, diabetes, and other chronic diseases are seeing worse outcomes. furthermore, the composition of the essential worker population is predominantly black and brown, who do not have the luxury of staying at home. this results in these workers returning to their segregated community with the higher potential of spreading infectious diseases. public health practitioners, health systems, and community-based organizations often do not have tools to understand the complex interaction of social determinants linked to poor health outcomes. given that disparate health outcomes from chronic conditions or pandemics such as covid- are influenced by sdh and underlying health conditions, the ability to target these high-risk communities and provide interventions with a high degree of precision is critical to slowing the spread of the pandemic. health opportunity index (hoi) is a tool to understand the effect of sdh on health outcomes. tools such as the hoi can demonstrate how the sdh can shape a community's overall opportunity for optimal health. using tools for geospatial analysis with data from the hoi is an effective method of identifying health disparities as well as the sdh, which drive these disparities out of control [ ] . a thematic map can overlay sdh over a community of interest, highlighting rates of a determinant or adverse health outcome in the area. while such an approach is functional-a more robust, informative method needs to be explored in order to develop a deeper understanding of a community's health. the hoi is a tool used to better identify the determinants in a community that drive poor health outcomes. the utilization of the hoi can assist in identifying communities with the lowest health outcomes and reduce health disparities. the hoi was developed by rexford anson-dwamena, an epidemiologist and gis/spatial analyst at virginia's public health department. the tool was later adopted by johnnie (chip) allen, director of health equity at the ohio department of health (odh). allen found that the hoi could become a useful asset in the state's effort to reduce health disparities and actively pursue true health equity. health equality calls for providing the same health interventions to all individuals, regardless of the level of health disparity they face. health equity, on the other hand, is achieved when every individual has the same opportunity to achieve their full health potential. achieving health equity requires the identification of communities that might need a variety of interventions to overcome social, economic, and structural barriers to reach their peak level of health. sdhs are multifaceted, complex and often operate at varying levels of severity from one neighborhood to the next. the dynamic nature of sdh makes it difficult to address them in a comprehensive manner. moreover, tools required for understanding the dynamic nature of sdh are needed now more than ever. one of odh's primary equity goals is to develop wide-spread capacity to identify and understand how specific sdhs operate at the local/neighborhood level. this understanding can empower local communities to comprehensively address these issues using targeted interventions with the help of broad-based coalitions. the hoi utilizes principal component analysis in order to create an individual score for each census tract. principal component analysis (pca) is a statistical procedure used in exploratory data analysis. pca is useful for data reduction and simplification, modeling, outlier detection, variable selection, classification, predictions, and unmixing. for the hoi, pca's data reduction functionality is critical. for example, literacy and educational determinants are both sdh and are strongly correlated. food accessibility and hunger behave similarly. for this reason, it can be useful to adopt clustering methodology approaches in an attempt to identify sdh within census tract profiles. common profiles include economic stability, education, health and built environment. while the hoi is a relatively new tool to the public health field, it shares similarities with another tool. the child opportunity index (coi) is a tool that measures the resources and conditions of a neighborhood that are critical to the development of a child [ ] . its purpose is similar to the hoi, in that the tool aims to compare opportunity levels of different neighborhoods around the country under one metric. therefore, the goals of the present analyses are to; ( ) educate environmental public health professionals and communities about the conditions children are exposed to in their neighborhoods, ( ) inform the relevant policy makers who control the distribution of resources, and ( ) improve equity and health outcomes in vulnerable populations. the index uses indicators to measure neighborhood health for residents. some of these indicators include school poverty, access to healthy food, access to green space, home ownership rate as well as other related indicators. each indicator has an individual weight which correlates to the indicators ability to impact health. the indicators are all measured on different scales. for example, high school graduation rate and employment rate are expressed using percentages versus the hazardous waste site index, which is measured using a count. in order to combine these values, the raw data is standardized using z-score transformation. these indicators are then combined into one of three domains: education, health and environment, and social and economic. the scores are then weighted based on their health and economic impact and combined to a single score, scaled between and . the coi contains information on over , census tracts that can be compared with other metro areas and across time periods. the coi . was released in and version . was released in january . disparate health outcomes do not exist in a vacuum. moreover, it is important but difficult to understand how disparate health outcomes simultaneously exist at their worst levels and the social determinants which impact these disparities. to help understand how these issues are connected, j. chip allen also developed the convergence analysis (ca) to help contextualize the hoi. the ca is a technique that uses geographically referenced health data with gis mapping tools to visualize where various disparate health outcomes simultaneously exist at their worst levels. any dataset that is geographically referenced can be used with the ca. this paper reflects the ca which uses selected data sets from the cdc behavior risk factor surveillance survey (brfss) cities project, - , ohio department of health vital statistics data on prematurity and as well as data on lead exposure from the ohio department of health at the census tract level. specific datasets for the brfss cities project data included crude prevalence rates of asthma, coronary heart disease, diabetes, high blood pressure, stroke, and poor mental health. the health opportunity index (hoi) is the primary outcome variable in this study and is comprised of indices: affordability, income inequality, townsend deprivation, job participation, employment access, education, population churning, population-weighted density, segregation, food accessibility, walkability, access to care, and environmental quality index. these indices are separated into profiles based on how they co-exist in the state of ohio. indices will fall into the environmental, consumer, mobility, or economic profile. hoi scores are calculated for each census tracts in order to highlight specific community needs. scores of census tracts were converted into shapefiles, then uploaded to arcgis to be displayed over a thematic map. hoi scores ranged from to . the closer to zero the score is, the lower the probability residents in the census tract have the opportunity to achieve optimal health. a score closer to signifies greater opportunity to achieve good health. the following section describes the methodology used to create the -index scores that make up the hoi within each of the four profiles. the environmental profile consists of six indices, which include affordability, health care access, walkability, employment, population density, and environmental quality. each index is described below. the affordability index measures the proportion of a neighborhood's income that is spent on housing and transportation. the equation used to derive the affordability index is as follows: the us census bureau has its own metric that it uses to measure poverty. however, this metric carries its own flaws as it assumes that the cost-of-living is uniform across the united states. this assumption is known to be false. to better account for this, the affordability index of the hoi identifies the most significant expenses a family incurs and weights the impact of that cost on disposable income [ ] . the two major expenses factored into affordability are housing and transportation. the proportion of income spent on these two combined factors help account for the cost-of living variability and provide a better sense of affordability. the health care access index measures an area's access to healthcare. the is accomplished using a two-step process to assess physician availability [ ] . first, within a predetermined travel radius from a healthcare provider, the total population that the supplier could reach is established. this is then converted to a provider-to population ratio, with the total number of providers in a healthcare setting being accounted for. next, once the area of interest (census tract) is established, the same predetermined travel radius is applied. every healthcare setting in the radius is captured and the provider-to-population ratios are summed to give part of the access to care index. the additional portion of the index comes from the percentage of uninsured population. the percentages come from the american community survey, which records uninsured levels at the census tract level. the walkability index is an epa tool used to differentiate census groups based on their walkability. the walkability of an area is based on the built environment that promotes or discourages walking as a mode of transportation. factors such as street connectivity, crime, and facilities for walking are examples of factors that can contribute to the walkability of an area [ ] . the walkability index is derived from a four-variable formula from the international physical activity and the environment network (ipen). the equation is as follows: wai = ( × con) + ent + far + hdens. ( the four variables represent what is known as the d's. design ( × con), diversity (ent), distance (far), and density (hdens) make up the new walkability index. design refers to the design of the built environment and safety features of an area. a large number of street crossings that support safe pedestrian travel in a census block will increase this variable. diversity refers to the diversity of land use in the census block. it measures the variety of activities that are within a walkable distance. distance measures the distance to transit or how accessible it is for pedestrians to reach a transit stop. density refers to residential and employment density. these variables measure the density of activities within a walkable distance. the employment access index measures the accessibility of jobs in a particular area. poor job access can include barriers such as distance from residents and transportation availability. communities that experience poor employment access tend to have more employment instability [ ] , which in turn leads to more socioeconomic disadvantages. the employment access index score is determined by utilizing a gravity model. the equation for the index is as follows: a i = job accessibility at location i, j j = the number jobs in location i, d = the travel time between them, β = the friction coefficient, n = the total number of job locations, v j = job location's proximity to all workers. this index is calculated by summing the total number of jobs in an area and dividing by the square of the distance to those jobs. this allows for further examination of the presence and proximity of jobs in an area. the gravity model makes it possible to observe what job opportunities are available in or around block group or census tract, which provides a better picture of job access. the population-weighted density index is critical to better understand the spatial differences between rural and urban populations [ ] . the index captures the density at which the average individual lives. the index is calculated by dividing the total population-weighted by the square miles in the area. the higher the index score, the higher the concentration of people per square mile. the environmental quality index is calculated using the epa's national air toxics assessments (nata) environmental data. this assesses the level of air pollution by census tract. the nata has six indicators: neurological risk, cancer risk, respiration risk, on-road pollution, non-road pollution, and non-point pollution. the six indicators are combined into one indicator using principal component analysis. principal component analysis converts the individual variables into latent variables which are then standardized into hazard quotients. higher hazard quotients result in a higher possibility that the exposure to environmental conditions will result in a negative health outcome. the consumer profile consists of three indices which include education, food access, and material deprivation. these indices are described below. the education index measures the average education level achieved by the adult population in an area [ ] . this is based on the average years of schooling in an area. higher educational attainment has been shown to have positive impacts on economic earning and positive health outcomes. the equation for this index is as follows: ays = average years of schooling, µ = average years of schooling for the concerned population, p i = proportion of population with certain level of schooling, y i = years of schooling at different education attainment levels. this index however does not take into account the quality of the education received, only average level of attainment. the food accessibility index measures low access to grocery stores, supermarket, and other suppliers of healthy foods. proximity to healthy food options plays a critical role in maintaining a well-balanced and healthy diet [ ] . the index score is based on the proportion of the census tract population that fits into one of three usda criteria. the criteria on whether a significant portion of the population ( individuals) or % of a low-income census tract live within a certain proximity to a grocery store or supermarket. the proximity to grocery store or supermarket depends on the population density of the census tract. residents who live further than . or mile away from a grocery store or supermarket in an urban area are considered to have low food access. residents who live further than or miles away from a grocery store or supermarket in a rural area are considered to have low food access. the townsend deprivation index is used to measure material deprivation. material deprivation, according to sociologist peter townsend, encompasses the lack of goods, services, amenities, resources and physical environment that are typically found and approved by society [ ] . the index is made up of four variables: unemployment, car ownership, home ownership, and overcrowding. the unemployment variable is derived by determining the percentage of active residents in a community between the ages of to who are unemployed. the car ownership variable is based on the percentage of private households who do not possess a car. home ownership is based off the percentage of private homes not currently occupied by the homeowner. the overcrowding variable is the percentage of private households with more than one person per room. each of these variables are equally weighed and combined together to determine the townsend deprivation index. in order to combine the variables, first the unemployment variable and the overcrowding variable must be log transformed. next, the z-score is calculated for each of the four variables and the scores are summed up for the composite score for the index. the higher the score, the more a particular area lacks access to the resources. the third profile in the hoi is the economic profile, which consists of three indices: job participation, segregation, and income inequality, which are described below: the job participation index is a measure of the percentage of working aged individuals ( - years of age) in the active labor force. the equation for the variable is as follows unlike the unemployment variable of the townsend deprivation index, the job participation index is supposed to identify the employment rate of the active working class of an area. this index is considered very sensitive to the attributes of the local community. attributes such as educational attainment, household composition, and car ownership can all influence an area's employment rates. this index is a strong indicator of economic growth and income, which are strong factors in individual and community health status [ ] . the higher the index, the healthier the labor market. the segregation index, or the spatial dissimilarity index, measures how the racial composition of a population in a census tract compares to that of the rest of the state [ ] . the mapping software tool arcgis (mapplerx, nashville, tn, usa) has a toolbox to assist in the calculation of this index. the equation to calculate spatial dissimilarity is noted below. the income inequality index within the hoi is measured using the gini coefficient. the gini coefficient (index) is a statistical measure typically used to measure economic inequality [ ] . of the coefficient accomplishes this by measuring the diversity of actual earned income of a neighborhood. the equation is as follows: µ = the mean of the variable (income), n = total number of observations, y i and y j = dollar values of income of individuals. absolute neighborhood equality, or homogeneity, would result in a gini coefficient of . complete diversity in income for a neighborhood would result in a gini coefficient of . income inequality is a critical variable to account for due to its correlation with health outcomes. as the wage gap in the united states continues to increase, the disparities in health outcomes and life expectancy between high-income and low-income americans continue to increase [ ] . the final profile in the hoi is the population mobility profile, which includes the population churning index and is described below. the churning index is used to capture the total migration of individuals into a community. population churning can bring both positive and negative aspects to a community. the in migration can bring an influx of social capital and opportunities. new community member can bring new business and employment opportunities. on the other hand, out migration can lead to the disruption of services that are critical to health and wellness [ ] . the equation for the population churning index is as follows: population churning rate = in migration + out migration total population . population churning accounts for population movement in a manner that is different from net migration. rather than simply indicating the balance of movement as net migration does, population churning gives a standardized measure of the amount of movement in relation to the population at large. for the hoi, census mobility data was used to show -year mobility patterns. to provide assurance that the hoi was truly sensitive to major shifts in health status throughout the state, we used the most general definitions of good health, i.e., "life expectancy at birth" (le) and "years of potential life lost" (ypll) data to determine if the hoi demonstrated systematic public health differences between areas. figure , above present's life expectancies at birth by hoi quintiles. the indicators (le and ypll) were chosen as the health outcomes of interest because they; ( ) provide a global indication of health across a population and across the life span; and ( ) summarize health in a manner that is easily understood by all-how long a life can i expect to live? our indicators also aligned with the notion that social determinants of health (sdh) are fundamental causes of disease. therefore, access or lack of access to sdh would be expected to influence the entire range of health outcomes, and not just those associated with the same behavior (for example, physical activity being associated with obesity and diabetes but not hiv). hoi was constructed to simplify a very complex social landscape important to the health of a community by specifying some very simple process-oriented indicators and determine how they interact within a local spatial context. of course, no traditional public health concern (e.g., infant mortality, asthma, or cardiovascular, stroke or hiv) is incorporated in the composite index. these are what we want to view in terms of the index. upon maximal refinement of the hoi, we can then explore how these health-based indicators relate to the broader community conditions. provide a global indication of health across a population and across the life span; and ( ) summarize health in a manner that is easily understood by all-how long a life can i expect to live? our indicators also aligned with the notion that social determinants of health (sdh) are fundamental causes of disease. therefore, access or lack of access to sdh would be expected to influence the entire range of health outcomes, and not just those associated with the same behavior (for example, physical activity being associated with obesity and diabetes but not hiv). the state of virginia is our reference point for the maturation of the hoi and in virginia, the aforementioned independent variables were analyzed to determine which of these variables were associated with birth outcomes. as can be seen in figure below, on a statewide level, infant mortality per live births increases with hoi quintile to demonstrate that hoi variables were in fact, associated with low birth weight infants and infant mortality. we can conclude that residents of very low hoi quintiles are more likely to experience infant deaths by a striking . % as compared to residents of very high hoi quintiles. this striking disparity and trajectory by hoi quintile are also true for diabetes hospitalization. areas" on average is expected to live over four more years compared to the persons in "very low opportunity areas". hoi was constructed to simplify a very complex social landscape important to the health of a community by specifying some very simple process-oriented indicators and determine how they interact within a local spatial context. of course, no traditional public health concern (e.g., infant mortality, asthma, or cardiovascular, stroke or hiv) is incorporated in the composite index. these are what we want to view in terms of the index. upon maximal refinement of the hoi, we can then explore how these health-based indicators relate to the broader community conditions. the state of virginia is our reference point for the maturation of the hoi and in virginia, the aforementioned independent variables were analyzed to determine which of these variables were associated with birth outcomes. as can be seen in figure below, on a statewide level, infant mortality per live births increases with hoi quintile to demonstrate that hoi variables were in fact, associated with low birth weight infants and infant mortality. we can conclude that residents of very low hoi quintiles are more likely to experience infant deaths by a striking . % as compared to residents of very high hoi quintiles. this striking disparity and trajectory by hoi quintile are also true for diabetes hospitalization. post processing of data via principal component analysis (pca): as described above, the indicators for the hoi were carefully chosen as core variables to provide a broad aerial view of an "opportunity structure" that can be easily and intuitively recognized by most community residents. these indicators therefore circumscribe what residents in a particular area have to navigate to accomplish their normal daily life tasks. we chose to apply principal component analysis (pca) to reduce the noise and the dimension of the data structure, as recently discussed by kahlia et al., ( ) [ ] . the -place based indicators were normalized (z scores), combined, and weighted using pca to discern local patterns in the data at the census tract level. the use of pca is greatest in scenarios where there are a large number of variables being considered in answering a question. in these post processing of data via principal component analysis (pca): as described above, the -indicators for the hoi were carefully chosen as core variables to provide a broad aerial view of an "opportunity structure" that can be easily and intuitively recognized by most community residents. these indicators therefore circumscribe what residents in a particular area have to navigate to accomplish their normal daily life tasks. we chose to apply principal component analysis (pca) to reduce the noise and the dimension of the data structure, as recently discussed by kahlia et al., ( ) [ ] . the -place based indicators were normalized (z scores), combined, and weighted using pca to discern local patterns in the data at the census tract level. the use of pca is greatest in scenarios where there are a large number of variables being considered in answering a question. in these situations, it is difficult to partition and understand how each variable is interacting [ ] . engaging in dimensional reduction reduces the amount of interactions between variables and pca achieves this through feature extraction by combining variables in specific ways. the methodology prioritizes critical parts of the variables while leaving out the less important aspects of the variables. therefore, pca was used in the present study to find the appropriate latent variables that might measure the landscape of an area. to maximize all indicators, the -indices were standardized into z-score and rotated using varimax with kaiser normalization method to retain four components based on an eigenvalue cut-off of or more. this process means that, if the eigenvalue is greater than , it indicates that that component explains more variance than a single variable because the sum of the eigenvalues equals the number of variables in the model. each component was weighted using the proportion of their variance explained in the model as a percent of the cumulative variance and summed (weighted sum) to compute the composite index for each census tract. the hoi analysis results are presented in table (below) using a census tract in cuyahoga county as an example. the analysis includes a number of data points which can be assessed. the primary data point is the hoi composite score. step : hoi composite score and profile scores range from to . the closer the score is to zero, the lower the chances for residents in the census tract to experience opportunity for good health. conversely, the closer the score is to , the greater the chances that residents will experience high opportunities for good health. the public health professional can gauge health opportunity by looking at the quintile. quintile reflects low health opportunity. quintile reflects high health opportunity. life expectancy can also help gauge health opportunity. step : once overall health opportunity is determined; the public health professional can search for the social determinants that drive health opportunity. this requires an analysis of each of the profile scores (environmental, consumer, economic, and population mobility) to discern the profile with the lowest score. step : based on the profile with the lowest score, (in this case, consumer profile) the public health professional would select the social determinant(s) for that profile with the lowest score (in this case, food access). step : a public health professional might use other available data for the convergence analysis (see methodology section). the convergence analysis reveals that there are six ( ) health outcomes that are simultaneously at the worst levels in this census tract. step : interpret/summarize findings ( data): census tract has overall low health opportunity for the residents to achieve good health. these sub-optimal outcomes include poor mental health, diabetes, stroke, coronary heart disease, asthma, and high blood pressure. the cities data also reflects that chronic obstructive pulmonary disease and kidney disease are at their worst levels. a deeper examination of the hoi data reveals that the social determinants of the consumer profile drive the observed poor health opportunity. a closer examination of the consumer profile reveals that food access is a major factor contributing factor to poor health opportunity in this census tract. as a result, the public health professional might recommend that interventions to improve overall health opportunity and disparate health conditions must take into account food access. as mentioned above, the composite index score serves to provide an overall indication for the health of a particular community. the relative profiles of a particular tract can then be examined to explain what variables are making the greatest contribution to a low (or high) composite score. by analyzing the various profile scores, the low numbers are indicative of the primary drivers of poor health opportunity in the community. by extrapolating further, the specific index within the profile can be identified as the primary driver of poor health opportunity in the community. the hoi analysis report in table provides an example of the composite score for a census tract in cuyahoga county. the . score is reflective of a low health opportunity for the census tract. this is reinforced by the score's inclusion in the first quintile. by examining the four profiles, the consumer profile is shown to be the primary driver of low health opportunity with a score of . . further, food access appears to be the index that is driving the consumer profile. table . health opportunity index score card. see text for details. the score card displays the composite, profile and index score from the hoi the scores range from to . the closer the number is to , the more responsible the score is for driving low health opportunity. the thematic mapping of hoi composite scores provides a visual breakdown of health opportunity disparities across census tracts in an area. figure depicts an arcgis map with a shapefile containing composite scores from the cuyahoga county area. using the thematic map feature from arcgis, differing census tract composite scores can be highlighted by quintile. the closer the census tract is to yellow, the lower the health opportunity. census tracts highlighted in red provide higher health opportunity. the concentration of yellow census tracts aligns with the metropolitan area of downtown cleveland, ohio. figure depicts the same hoi composite score but in the franklin county area. the concentration of the yellow census tracts aligns with the metropolitan area of downtown columbus, ohio. the thematic mapping of hoi composite scores provides a visual breakdown of health opportunity disparities across census tracts in an area. figure depicts an arcgis map with a shapefile containing composite scores from the cuyahoga county area. using the thematic map feature from arcgis, differing census tract composite scores can be highlighted by quintile. the closer the census tract is to yellow, the lower the health opportunity. census tracts highlighted in red provide higher health opportunity. the concentration of yellow census tracts aligns with the metropolitan area of downtown cleveland, ohio. figure depicts the same hoi composite score but in the franklin county area. the concentration of the yellow census tracts aligns with the metropolitan area of downtown columbus, ohio. to determine the validity of the health opportunity index's ability to predict high or low health opportunity, a disease convergence layer was added to the map. a disease convergent area is a census tract where multiple negative health outcomes simultaneously occur at their worst levels. using the cities online database, crude prevalence rates for health outcomes such as coronary heart disease, copd, asthma, chronic kidney disease, and diabetes were analyzed at the census tract level. figure shows a hoi composite score map for the hamilton county area. similar to the map from figure the thematic mapping of hoi composite scores provides a visual breakdown of health opportunity disparities across census tracts in an area. figure depicts an arcgis map with a shapefile containing composite scores from the cuyahoga county area. using the thematic map feature from arcgis, differing census tract composite scores can be highlighted by quintile. the closer the census tract is to yellow, the lower the health opportunity. census tracts highlighted in red provide higher health opportunity. the concentration of yellow census tracts aligns with the metropolitan area of downtown cleveland, ohio. figure depicts the same hoi composite score but in the franklin county area. the concentration of the yellow census tracts aligns with the metropolitan area of downtown columbus, ohio. to determine the validity of the health opportunity index's ability to predict high or low health opportunity, a disease convergence layer was added to the map. a disease convergent area is a census tract where multiple negative health outcomes simultaneously occur at their worst levels. using the cities online database, crude prevalence rates for health outcomes such as coronary heart disease, copd, asthma, chronic kidney disease, and diabetes were analyzed at the census tract level. figure shows a hoi composite score map for the hamilton county area. similar to the map from figure to determine the validity of the health opportunity index's ability to predict high or low health opportunity, a disease convergence layer was added to the map. a disease convergent area is a census tract where multiple negative health outcomes simultaneously occur at their worst levels. using the cities online database, crude prevalence rates for health outcomes such as coronary heart disease, copd, asthma, chronic kidney disease, and diabetes were analyzed at the census tract level. figure shows a hoi composite score map for the hamilton county area. similar to the map from figure in cuyahoga county, the census tracts with the lowest opportunity scores are highlighted in yellow and concentrated around the metropolitan area around downtown cincinnati, ohio. the convergence analysis for census tract fips code revealed that there were six health conditions that simultaneously exist at their worst levels. they include poor mental health, diabetes, stroke, coronary heart disease, asthma, and high blood pressure. in figure , the additional layer for disease convergence in hamilton county ohio has been added to the map as a cluster of outlined census tracts in the lowest scoring areas. in cuyahoga county, the census tracts with the lowest opportunity scores are highlighted in yellow and concentrated around the metropolitan area around downtown cincinnati, ohio. the convergence analysis for census tract fips code revealed that there were six health conditions that simultaneously exist at their worst levels. they include poor mental health, diabetes, stroke, coronary heart disease, asthma, and high blood pressure. in figure , the additional layer for disease convergence in hamilton county ohio has been added to the map as a cluster of outlined census tracts in the lowest scoring areas. the hoi can function as an essential tool in advancing health equity. it is important to note that the hoi tool is not meant to assess health outcome. the purpose of this tool is to provide public health practitioners, policy makers, and local organizations with a tool to assess sdh at the census tract level. the hoi can then inform the actions of policy makers and local communities who embark in cuyahoga county, the census tracts with the lowest opportunity scores are highlighted in yellow and concentrated around the metropolitan area around downtown cincinnati, ohio. the convergence analysis for census tract fips code revealed that there were six health conditions that simultaneously exist at their worst levels. they include poor mental health, diabetes, stroke, coronary heart disease, asthma, and high blood pressure. in figure , the additional layer for disease convergence in hamilton county ohio has been added to the map as a cluster of outlined census tracts in the lowest scoring areas. the hoi can function as an essential tool in advancing health equity. it is important to note that the hoi tool is not meant to assess health outcome. the purpose of this tool is to provide public health practitioners, policy makers, and local organizations with a tool to assess sdh at the census tract level. the hoi can then inform the actions of policy makers and local communities who embark the hoi can function as an essential tool in advancing health equity. it is important to note that the hoi tool is not meant to assess health outcome. the purpose of this tool is to provide public health practitioners, policy makers, and local organizations with a tool to assess sdh at the census tract level. the hoi can then inform the actions of policy makers and local communities who embark on the difficult work of improving the most serious health concerns of their communities by addressing the sdh that impacts health. first, the hoi provides a method of comparing overall health opportunities of surrounding areas using the composite score. it is important to note that the hoi does not function as a health ranking. while the composite hoi score can be used for comparison of health opportunity among counties, its great advantage is its ability to highlight challenges and opportunities within the county and its census tracts. when applying and allocating funds for health-related grants, it is critical that all parties use a tool that is standardized to provide a common understanding of sdh which drive health outcomes. the hoi also provides insight to similar challenges faced by different communities. the ability to highlight which census tracts have the lowest opportunities for optimal health can lead to specific policies, social, economic, environmental and structural changes to advance health equity. further, breaking down the hoi by examining its subcomponents makes it possible to highlight which aspects of a community need the most attention to increase overall health. for example, in table , the consumer profile has a score of . which is identified as the primary driver of low health opportunity. the food access index score of . signifies that the census block in cuyahoga county suffers particularly from access to grocery stores, supermarkets and other suppliers of healthy food. with this information, the state's public health department or community supporters could implement healthy food interventions to improve food access. this detailed process offers a more accurate method of addressing health equity issues. the disease convergence layer is added over the hoi in order to provide better context of health. that is, to understand how different types of health disparities, at their worst levels, reflect low health opportunity and all of its complications. figure highlights census tracts that are highlighted as convergence areas in hamilton county. each of the convergence area census tracts highlighted are in low health opportunity census tracts. the occurrence of multiple chronic health conditions simultaneously present at their worst levels in a single census tract indicate the influence of challenging sdh on these disparities. one of the shortcomings in public health practice is the proliferation of programmatic silos, which often address a particular health issue at any given time. convergence analysis provides the opportunity for cross sector collaboration. in a census tract where diabetes, heart disease and hypertension all are occurring at their highest levels, health organizations with different programs can combine resources to address health conditions simultaneously. moreover, the hoi empowers collaborating organizations to be able to identify specific sdh to focus their collaborative interventions on. the hoi provides a large-scale image of an area's health opportunity. figure highlights the census tracts that make up cuyahoga county. the thematic map presented displays the concentration of low health opportunity census tracts closer to proximity to downtown cleveland. urbanization provides a number of factors that can drive the health opportunity of an area down such as overcrowding, air pollution, and high unemployment rates [ ] . these factors provide a potential explanation of the differences in health opportunity between downtown cleveland in figure and columbus in figure and their surrounding suburban census tracts. additionally, the thematic map allows stakeholders and policy makers to identify potential systematic issues that could be linked to low health opportunities. demographic information on the low health opportunity census tracts are publicly available. for figure , the converging point for the cluster of low health opportunity census tracts is cleveland city, ohio. according to the united states census bureau, the cleveland city comprises approximately % of the cuyahoga county population and is predominately african american ( . %) [ ] . combining this knowledge with the hoi provides the potential for highly detailed and accommodating interventions in areas of the most need. our dashboard can be utilized by state and local health departments in municipalities across the us. microsoft access and arcgis online can be used to link the hoi with convergence analysis to create reports and thematic maps to better visualize and contextualize both datasets to target vulnerable communities. in the present study, the use of cities data featuring the natural brakes classification method with seven ( ) classes proved to be very useful, as was the - vital statistics data on prematurity, and the lead data using the equal ranges classification method with five classes (brfss ). each dataset was selected based on the highest two classes that reflected the highest burden of disease. all data were imported into a ms access database system. a query entitled "convergence" was created to create linking both dataset by the census tract fips code. a report was then created to identify census tracts that had at least four ( ) of any of the conditions with a given census tract. additionally, to identify census tracts for the convergence of different health issues, a filter tool in arcgis online can be easily applied. by selecting the map layers with the appropriate data, it is possible to mimic the function of the ms access query by using the filter for the highest rates of disease based on the natural breaks or equal range classes of the original dataset. relevant to the public health emergency that we are currently experiencing, the hoi provides an opportunity for municipalities to address the capacity of health systems by identifying areas where the availability of physicians are low using a provider-to-population ratio. prior to the covid- pandemic, the hoi was able to identify communities where access to health care was limited. this access, or lack thereof, would be expected to be further exacerbated and strained during a pandemic such as the current covid- pandemic. as we have witnessed, as the pandemic has worsened across the united states, we continue to observe an increase in the population in need of health care as cases of covid- continue to rise. further, it is now apparent that these very low and low hoi areas are synonymous with the census tracts that are most disproportionately impacted in the covid- pandemic. therefore, we put forth the proposition that this novel tool will allow local, state, regional and national agencies to respond to covid- impacted areas and other chronic health concerns due to its ability to predict and identify communities were the need for a robust response is likely to be the greatest. the hoi utilizes data sets from a variety of sources. for urban areas, often times this information is more readily available and accessible. however, for rural areas, the inability to access these data could prove difficult to incorporate the hoi evenly across an entire state. the hoi is still in its early stages of implementation so, cleveland, columbus, and cincinnati are the initial major cities that have been hoi mapped across census tracts. additionally, the hoi is created on a state by state basis. the index is built according to available datasets at the census tract level for that particular state, including variables that stakeholders and health departments identify as important and actionable. if the variables can be linked to health outcomes through academic literature, then they will serve as the framework for that area's hoi. the hoi for the state of ohio does not contain the same indices as the hoi for the state of virginia. for this reason, cross state comparisons would prove to be difficult. hopefully, nationwide adoption of the hoi would facilitate the creation of a nationwide baseline hoi. finally, the hoi is a measure of access or availability of opportunity within a community. this tool does not measure utilization or individual level barriers but rather assesses opportunity at the community level. likewise, the hoi is not designed to address the sociocultural, organizational, geographic, and gender-related barriers in health care. again, the purpose of the hoi tool is to move beyond the health care setting and examine the social determinants of health that impact health outcomes. while health care is an important determinant, the tool is aimed at assessing access to healthcare based on the availability of physicians and that segment of the population that is uninsured. therefore, these issues are limitations of the hoi tool. the differences in opportunity to achieve optimal health among communities around the state of ohio further exasperate the disparities in health between these communities. the hoi is a novel tool capable of aiding public health officials and local stakeholders alike in identifying the differences in health opportunity. conditions that drive poor health are extremely complex, exemplified by the possibility of two adjacent census tracts having low hoi scores caused by different sdh. without having tools such as the hoi to understand which specific sdh drive poor health opportunity, it is highly likely that the wrong interventions will be applied, which will negatively impact efforts to advance health equity. it is not sufficient to just identify the differences, but understanding what factors are potentially driving down health are necessary for impactful health interventions. using geospatial mapping tools such as arcgis, it is possible to create interactive tools that facilitate collaborative efforts to address the sdh on many different levels to improve impact disparate chronic health outcomes in census tracts. as communities continue to diversify, so do their health concerns and troubles. addressing these growing concerns will require a more detailed intervention methodology by public health officials [ ] . the implementation of the hoi presents a new tool to assist in this process. the fact that -of the indices in the hoi are related to socioeconomic factors, its use in conjunction with the public health exposome framework presents an exciting future for environmental health science [ ] . the recently described public health exposome framework can model the relationships between environmental and socio-demographic variables and health outcomes [ ] . we have used the exposome framework to reveal latent associations between chemical stressors and low birth weights and pre-term births, both which have high prevalence rates in ohio. both the public health exposome and the hoi incorporate datasets from a variety of locations to present a geographical approach to combating health disparities. parallel use of these frameworks may prove to be beneficial to public health officials and local stakeholders alike. in combination with the public health exposome, the question as to how chemical stressors such as components of ambient pollution negatively impact vulnerable populations to result in premature death, including ischemic cardiovascular disease, stroke, respiratory infections, chronic obstructive pulmonary disease, and lung cancer might be more appropriately addressed [ ] [ ] [ ] [ ] [ ] . using the public health exposome [ ] [ ] [ ] and hoi analytics to integrate public health with exposure science and population-based epidemiological designs will likely provide novel and innovative theories and interventions to address disparate health outcomes. a recent study used data from the global burden of disease study to address the question: "how much does exposure to chemical stressor (as pm . air pollution) shorten human life expectancy around the world?" the study used a prior dataset that evaluated chemical stressor levels in and from us counties and effects on life expectancy. the analysis revealed that in , chemical stressor exposure reduced average global life expectancy at birth by ∼ year with reductions of ∼ . - . years in polluted countries of asia and africa. a major conclusion from that study was; if exposure to chemical stressors in all countries met the world health organization air quality guideline ( µg/m ), the estimated life expectancy would increase by a population-weighted median of . year (interquartile range of . - . year), a benefit of a magnitude similar to that 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